PRODUCTID PRODUCTNDC PRODUCTTYPENAME PROPRIETARYNAME PROPRIETARYNAMESUFFIX NONPROPRIETARYNAME DOSAGEFORMNAME ROUTENAME STARTMARKETINGDATE ENDMARKETINGDATE MARKETINGCATEGORYNAME APPLICATIONNUMBER LABELERNAME SUBSTANCENAME ACTIVE_NUMERATOR_STRENGTH ACTIVE_INGRED_UNIT PHARM_CLASSES DEASCHEDULE 0002-1200_4322f73b-3cb5-4e67-a909-0725bbe666c3 0002-1200 HUMAN PRESCRIPTION DRUG Amyvid Florbetapir F 18 INJECTION, SOLUTION INTRAVENOUS 20120601 NDA NDA202008 Eli Lilly and Company FLORBETAPIR F-18 51 mCi/mL Radioactive Diagnostic Agent [EPC],Positron Emitting Activity [MoA] 0002-1407_e7af3676-cd9d-4c30-b127-9f6c46ff1589 0002-1407 HUMAN PRESCRIPTION DRUG Quinidine Gluconate Quinidine Gluconate SOLUTION INTRAVENOUS 19510301 NDA NDA007529 Eli Lilly and Company QUINIDINE GLUCONATE 80 mg/mL Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] 0002-1433_74a7bee2-54e0-4d64-bbe6-cf542ea74bbb 0002-1433 HUMAN PRESCRIPTION DRUG Trulicity Dulaglutide INJECTION, SOLUTION SUBCUTANEOUS 20141001 BLA BLA125469 Eli Lilly and Company DULAGLUTIDE .75 mg/.5mL 0002-1434_74a7bee2-54e0-4d64-bbe6-cf542ea74bbb 0002-1434 HUMAN PRESCRIPTION DRUG Trulicity Dulaglutide INJECTION, SOLUTION SUBCUTANEOUS 20141001 BLA BLA125469 Eli Lilly and Company DULAGLUTIDE 1.5 mg/.5mL 0002-1975_530a0021-450d-4fea-9e96-8e2a8b590684 0002-1975 HUMAN PRESCRIPTION DRUG AXIRON testosterone SOLUTION TOPICAL 20101201 NDA NDA022504 Eli Lilly and Company TESTOSTERONE 30 mg/1.5mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0002-3004_ee18b5a1-2942-46b5-9f57-cb983ef14bbe 0002-3004 HUMAN PRESCRIPTION DRUG Prozac Weekly Fluoxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20010316 NDA NDA021235 Eli Lilly and Company FLUOXETINE HYDROCHLORIDE 90 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0002-3227_c3c47b76-f1d4-4ec5-9057-803a4e918b98 0002-3227 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 Eli Lilly and Company ATOMOXETINE HYDROCHLORIDE 10 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 0002-3228_c3c47b76-f1d4-4ec5-9057-803a4e918b98 0002-3228 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 Eli Lilly and Company ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 0002-3229_c3c47b76-f1d4-4ec5-9057-803a4e918b98 0002-3229 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 Eli Lilly and Company ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 0002-3230_5cfbd12c-6be4-4ac3-a91a-80e201226476 0002-3230 HUMAN PRESCRIPTION DRUG Symbyax Olanzapine and Fluoxetine hydrochloride CAPSULE ORAL 20070409 NDA NDA021520 Eli Lilly and Company FLUOXETINE HYDROCHLORIDE; OLANZAPINE 25; 3 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0002-3231_5cfbd12c-6be4-4ac3-a91a-80e201226476 0002-3231 HUMAN PRESCRIPTION DRUG Symbyax Olanzapine and Fluoxetine hydrochloride CAPSULE ORAL 20040119 NDA NDA021520 Eli Lilly and Company FLUOXETINE HYDROCHLORIDE; OLANZAPINE 25; 6 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0002-3232_5cfbd12c-6be4-4ac3-a91a-80e201226476 0002-3232 HUMAN PRESCRIPTION DRUG Symbyax Olanzapine and Fluoxetine hydrochloride CAPSULE ORAL 20040119 NDA NDA021520 Eli Lilly and Company FLUOXETINE HYDROCHLORIDE; OLANZAPINE 25; 12 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0002-3233_5cfbd12c-6be4-4ac3-a91a-80e201226476 0002-3233 HUMAN PRESCRIPTION DRUG Symbyax Olanzapine and Fluoxetine hydrochloride CAPSULE ORAL 20040119 NDA NDA021520 Eli Lilly and Company FLUOXETINE HYDROCHLORIDE; OLANZAPINE 50; 6 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0002-3234_5cfbd12c-6be4-4ac3-a91a-80e201226476 0002-3234 HUMAN PRESCRIPTION DRUG Symbyax Olanzapine and Fluoxetine hydrochloride CAPSULE ORAL 20040119 NDA NDA021520 Eli Lilly and Company FLUOXETINE HYDROCHLORIDE; OLANZAPINE 50; 12 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0002-3235_5c54ac0e-6074-43eb-a1c2-8b7064378212 0002-3235 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Eli Lilly and Company DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0002-3238_c3c47b76-f1d4-4ec5-9057-803a4e918b98 0002-3238 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 Eli Lilly and Company ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 0002-3239_c3c47b76-f1d4-4ec5-9057-803a4e918b98 0002-3239 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 Eli Lilly and Company ATOMOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 0002-3240_5c54ac0e-6074-43eb-a1c2-8b7064378212 0002-3240 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Eli Lilly and Company DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0002-3250_c3c47b76-f1d4-4ec5-9057-803a4e918b98 0002-3250 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20060301 NDA NDA021411 Eli Lilly and Company ATOMOXETINE HYDROCHLORIDE 80 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 0002-3251_c3c47b76-f1d4-4ec5-9057-803a4e918b98 0002-3251 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20060301 NDA NDA021411 Eli Lilly and Company ATOMOXETINE HYDROCHLORIDE 100 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 0002-3270_5c54ac0e-6074-43eb-a1c2-8b7064378212 0002-3270 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20100115 NDA NDA021427 Eli Lilly and Company DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0002-4112_ef1ff1d3-09be-47ef-89a2-c7494215be74 0002-4112 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19970623 NDA NDA020592 Eli Lilly and Company OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 0002-4115_ef1ff1d3-09be-47ef-89a2-c7494215be74 0002-4115 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 Eli Lilly and Company OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 0002-4116_ef1ff1d3-09be-47ef-89a2-c7494215be74 0002-4116 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 Eli Lilly and Company OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 0002-4117_ef1ff1d3-09be-47ef-89a2-c7494215be74 0002-4117 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 Eli Lilly and Company OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 0002-4165_54fdc48e-f164-4e4a-b057-b784231f8a48 0002-4165 HUMAN PRESCRIPTION DRUG Evista Raloxifene hydrochloride TABLET ORAL 19980106 NDA NDA020815 Eli Lilly and Company RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 0002-4415_ef1ff1d3-09be-47ef-89a2-c7494215be74 0002-4415 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20000110 NDA NDA020592 Eli Lilly and Company OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 0002-4420_ef1ff1d3-09be-47ef-89a2-c7494215be74 0002-4420 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20010301 NDA NDA020592 Eli Lilly and Company OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 0002-4453_ef1ff1d3-09be-47ef-89a2-c7494215be74 0002-4453 HUMAN PRESCRIPTION DRUG ZYPREXA Zydis Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20000601 NDA NDA021086 Eli Lilly and Company OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 0002-4454_ef1ff1d3-09be-47ef-89a2-c7494215be74 0002-4454 HUMAN PRESCRIPTION DRUG ZYPREXA Zydis Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20000601 NDA NDA021086 Eli Lilly and Company OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 0002-4455_ef1ff1d3-09be-47ef-89a2-c7494215be74 0002-4455 HUMAN PRESCRIPTION DRUG ZYPREXA Zydis Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20010901 NDA NDA021086 Eli Lilly and Company OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 0002-4456_ef1ff1d3-09be-47ef-89a2-c7494215be74 0002-4456 HUMAN PRESCRIPTION DRUG ZYPREXA Zydis Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20010901 NDA NDA021086 Eli Lilly and Company OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 0002-4462_481c7868-2d86-4ecf-96e5-609c4a887dee 0002-4462 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Eli Lilly and Company TADALAFIL 5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0002-4463_481c7868-2d86-4ecf-96e5-609c4a887dee 0002-4463 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Eli Lilly and Company TADALAFIL 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0002-4464_481c7868-2d86-4ecf-96e5-609c4a887dee 0002-4464 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Eli Lilly and Company TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0002-4465_481c7868-2d86-4ecf-96e5-609c4a887dee 0002-4465 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20080107 NDA NDA021368 Eli Lilly and Company TADALAFIL 2.5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0002-4770_1814c9b1-201a-4389-9a60-0ae9cc5006af 0002-4770 HUMAN PRESCRIPTION DRUG Livalo pitavastatin calcium TABLET, FILM COATED ORAL 20100515 NDA NDA022363 Eli Lilly and Company PITAVASTATIN CALCIUM 1 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0002-4771_1814c9b1-201a-4389-9a60-0ae9cc5006af 0002-4771 HUMAN PRESCRIPTION DRUG Livalo pitavastatin calcium TABLET, FILM COATED ORAL 20100515 NDA NDA022363 Eli Lilly and Company PITAVASTATIN CALCIUM 2 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0002-4772_1814c9b1-201a-4389-9a60-0ae9cc5006af 0002-4772 HUMAN PRESCRIPTION DRUG Livalo pitavastatin calcium TABLET, FILM COATED ORAL 20100515 NDA NDA022363 Eli Lilly and Company PITAVASTATIN CALCIUM 4 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0002-5121_13e7ccaa-0643-484a-add7-0ccc2fb10246 0002-5121 HUMAN PRESCRIPTION DRUG Effient Prasugrel hydrochloride TABLET, FILM COATED ORAL 20120301 NDA NDA022307 Eli Lilly and Company PRASUGREL HYDROCHLORIDE 5 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 0002-5123_13e7ccaa-0643-484a-add7-0ccc2fb10246 0002-5123 HUMAN PRESCRIPTION DRUG Effient Prasugrel hydrochloride TABLET, FILM COATED ORAL 20120301 NDA NDA022307 Eli Lilly and Company PRASUGREL HYDROCHLORIDE 10 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 0002-7140_da423d8f-0105-410f-8384-43b5df8603b4 0002-7140 HUMAN PRESCRIPTION DRUG REOPRO abciximab INJECTION, SOLUTION INTRAVENOUS 19931216 BLA BLA103575 Eli Lilly and Company ABCIXIMAB 2 mg/mL 0002-7335_b1d3aee8-a192-4bbb-a3e9-2f4c1e27ebf5 0002-7335 HUMAN PRESCRIPTION DRUG HUMATROPE Somatropin KIT INTRAMUSCULAR; SUBCUTANEOUS 19870401 NDA NDA019640 Eli Lilly and Company 0002-7501_86761cc7-ee40-4d33-b4f2-fe6c81900a77 0002-7501 HUMAN PRESCRIPTION DRUG Gemzar Gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19960522 NDA NDA020509 Eli Lilly and Company GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0002-7502_86761cc7-ee40-4d33-b4f2-fe6c81900a77 0002-7502 HUMAN PRESCRIPTION DRUG Gemzar Gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19960522 NDA NDA020509 Eli Lilly and Company GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0002-7510_c2c423aa-2d1b-47bd-b84d-7c28d7a3784d 0002-7510 HUMAN PRESCRIPTION DRUG Humalog Insulin lispro INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19960724 NDA NDA020563 Eli Lilly and Company INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0002-7511_e9211eab-d0f2-4043-8974-e47a09a0c9ee 0002-7511 HUMAN PRESCRIPTION DRUG Humalog Mix75/25 Insulin lispro INJECTION, SUSPENSION SUBCUTANEOUS 19991222 NDA NDA021017 Eli Lilly and Company INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0002-7512_e6f896f2-77ea-4045-8734-b791be72b1cd 0002-7512 HUMAN PRESCRIPTION DRUG Humalog Mix50/50 Insulin lispro INJECTION, SUSPENSION SUBCUTANEOUS 20060207 NDA NDA021018 Eli Lilly and Company INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0002-7516_c2c423aa-2d1b-47bd-b84d-7c28d7a3784d 0002-7516 HUMAN PRESCRIPTION DRUG Humalog Insulin lispro INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19980220 NDA NDA020563 Eli Lilly and Company INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0002-7597_ef1ff1d3-09be-47ef-89a2-c7494215be74 0002-7597 HUMAN PRESCRIPTION DRUG ZYPREXA Intramuscular Olanzapine INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20040401 NDA NDA021253 Eli Lilly and Company OLANZAPINE 10 mg/2mL Atypical Antipsychotic [EPC] 0002-7623_e30a34c7-b935-4e34-a66f-7dafa4f72ea2 0002-7623 HUMAN PRESCRIPTION DRUG Alimta Pemetrexed disodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20040213 NDA NDA021462 Eli Lilly and Company PEMETREXED DISODIUM 500 mg/20mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0002-7635_35d0bf2e-75d6-4077-8690-cb2f0a54af82 0002-7635 HUMAN PRESCRIPTION DRUG ZYPREXA Relprevv Olanzapine pamoate KIT INTRAMUSCULAR 20100301 NDA NDA022173 Eli Lilly and Company 0002-7636_35d0bf2e-75d6-4077-8690-cb2f0a54af82 0002-7636 HUMAN PRESCRIPTION DRUG ZYPREXA Relprevv Olanzapine pamoate KIT INTRAMUSCULAR 20100301 NDA NDA022173 Eli Lilly and Company 0002-7637_35d0bf2e-75d6-4077-8690-cb2f0a54af82 0002-7637 HUMAN PRESCRIPTION DRUG ZYPREXA Relprevv Olanzapine pamoate KIT INTRAMUSCULAR 20100301 NDA NDA022173 Eli Lilly and Company 0002-7640_e30a34c7-b935-4e34-a66f-7dafa4f72ea2 0002-7640 HUMAN PRESCRIPTION DRUG Alimta Pemetrexed disodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080115 NDA NDA021462 Eli Lilly and Company PEMETREXED DISODIUM 100 mg/4mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0002-7669_41a768cb-a0ad-4d43-8e4c-8fc10504a209 0002-7669 HUMAN PRESCRIPTION DRUG CYRAMZA ramucirumab SOLUTION INTRAVENOUS 20140421 BLA BLA125477 Eli Lilly and Company RAMUCIRUMAB 10 mg/mL 0002-7678_41a768cb-a0ad-4d43-8e4c-8fc10504a209 0002-7678 HUMAN PRESCRIPTION DRUG CYRAMZA ramucirumab SOLUTION INTRAVENOUS 20140421 BLA BLA125477 Eli Lilly and Company RAMUCIRUMAB 10 mg/mL 0002-8031_6ec7d335-6b45-42a0-8fe6-7e2f53e23758 0002-8031 HUMAN PRESCRIPTION DRUG Glucagon glucagon KIT 19990301 NDA NDA020928 Eli Lilly and Company 0002-8147_b1d3aee8-a192-4bbb-a3e9-2f4c1e27ebf5 0002-8147 HUMAN PRESCRIPTION DRUG HUMATROPE Somatropin KIT INTRAMUSCULAR; SUBCUTANEOUS 20060127 NDA NDA019640 Eli Lilly and Company 0002-8148_b1d3aee8-a192-4bbb-a3e9-2f4c1e27ebf5 0002-8148 HUMAN PRESCRIPTION DRUG HUMATROPE Somatropin KIT INTRAMUSCULAR; SUBCUTANEOUS 20060127 NDA NDA019640 Eli Lilly and Company 0002-8149_b1d3aee8-a192-4bbb-a3e9-2f4c1e27ebf5 0002-8149 HUMAN PRESCRIPTION DRUG HUMATROPE Somatropin KIT INTRAMUSCULAR; SUBCUTANEOUS 20060127 NDA NDA019640 Eli Lilly and Company 0002-8215_20aaa7c2-bbd4-41a1-9ec8-00fc616671b3 0002-8215 HUMAN OTC DRUG Humulin R Insulin human INJECTION, SOLUTION PARENTERAL 20100610 NDA NDA018780 Eli Lilly and Company INSULIN HUMAN 100 [iU]/mL 0002-8215_2476a377-7577-4467-a7e9-d106e75c886a 0002-8215 HUMAN OTC DRUG Humulin R Insulin human INJECTION, SOLUTION PARENTERAL 19830627 NDA NDA018780 Eli Lilly and Company INSULIN HUMAN 100 [iU]/mL 0002-8315_500a6e55-8591-4c8e-aabe-40a2f15e300b 0002-8315 HUMAN OTC DRUG Humulin N Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 19830627 NDA NDA018781 Eli Lilly and Company INSULIN HUMAN 100 [iU]/mL 0002-8315_7d47a9c3-c7fe-40ca-bb65-b9c38fb883fa 0002-8315 HUMAN OTC DRUG Humulin N Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 20100610 NDA NDA018781 Eli Lilly and Company INSULIN HUMAN 100 [iU]/mL 0002-8400_15e46511-c1ce-487b-a7ef-d44202601541 0002-8400 HUMAN PRESCRIPTION DRUG Forteo Teriparatide INJECTION, SOLUTION SUBCUTANEOUS 20081001 NDA NDA021318 Eli Lilly and Company TERIPARATIDE 250 ug/mL Parathyroid Hormone [Chemical/Ingredient],Parathyroid Hormone Analog [EPC] 0002-8501_56852e9d-9832-4a7e-a19f-7ae855017bd6 0002-8501 HUMAN PRESCRIPTION DRUG Humulin R U-500 Insulin human INJECTION, SOLUTION SUBCUTANEOUS 19970106 NDA NDA018780 Eli Lilly and Company INSULIN HUMAN 500 [iU]/mL Insulin [Chemical/Ingredient],Insulin [EPC] 0002-8715_33c8bf82-faa6-4ccf-8b8f-83e9a6f971bc 0002-8715 HUMAN OTC DRUG Humulin 70/30 Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 20100610 NDA NDA019717 Eli Lilly and Company INSULIN HUMAN 100 [iU]/mL 0002-8715_5bad88c7-f2e9-43ca-913d-5bfa7ea9909f 0002-8715 HUMAN OTC DRUG Humulin 70/30 Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 19890626 NDA NDA019717 Eli Lilly and Company INSULIN HUMAN 100 [iU]/mL 0002-8730_500a6e55-8591-4c8e-aabe-40a2f15e300b 0002-8730 HUMAN OTC DRUG Humulin N Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 19990201 20151031 NDA NDA018781 Eli Lilly and Company INSULIN HUMAN 100 [iU]/mL 0002-8770_5bad88c7-f2e9-43ca-913d-5bfa7ea9909f 0002-8770 HUMAN OTC DRUG Humulin 70/30 Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 19990201 20151031 NDA NDA019717 Eli Lilly and Company INSULIN HUMAN 100 [iU]/mL 0002-8797_e9211eab-d0f2-4043-8974-e47a09a0c9ee 0002-8797 HUMAN PRESCRIPTION DRUG Humalog Mix75/25 KwikPen Insulin lispro INJECTION, SUSPENSION SUBCUTANEOUS 20080116 NDA NDA021017 Eli Lilly and Company INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0002-8798_e6f896f2-77ea-4045-8734-b791be72b1cd 0002-8798 HUMAN PRESCRIPTION DRUG Humalog Mix50/50 KwikPen Insulin lispro INJECTION, SUSPENSION SUBCUTANEOUS 20060207 NDA NDA021018 Eli Lilly and Company INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0002-8799_c2c423aa-2d1b-47bd-b84d-7c28d7a3784d 0002-8799 HUMAN PRESCRIPTION DRUG Humalog KwikPen Insulin lispro INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20080116 NDA NDA020563 Eli Lilly and Company INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0002-8803_5bad88c7-f2e9-43ca-913d-5bfa7ea9909f 0002-8803 HUMAN OTC DRUG Humulin 70/30 Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 20131107 NDA NDA019717 Eli Lilly and Company INSULIN HUMAN 100 [iU]/mL 0002-8805_500a6e55-8591-4c8e-aabe-40a2f15e300b 0002-8805 HUMAN OTC DRUG Humulin N Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 20131107 NDA NDA018781 Eli Lilly and Company INSULIN HUMAN 100 [iU]/mL 0003-0249_7d355981-e4d6-4d06-a2b3-eb83edce221b 0003-0249 HUMAN PRESCRIPTION DRUG HALOG Halcinonide SOLUTION TOPICAL 20090101 NDA NDA017823 E.R. Squibb & Sons, L.L.C. HALCINONIDE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0003-0293_5e263d16-bc5c-4e08-b712-da8c75187c3c 0003-0293 HUMAN PRESCRIPTION DRUG KENALOG-40 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 20090601 NDA NDA014901 E.R. Squibb & Sons, L.L.C. TRIAMCINOLONE ACETONIDE 40 mg/mL 0003-0371_1834cca2-134c-44bb-9d96-f517fc5e4e82 0003-0371 HUMAN PRESCRIPTION DRUG NULOJIX BELATACEPT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110615 BLA BLA125288 E.R. Squibb & Sons, L.L.C. BELATACEPT 250 mg/1 T Lymphocyte Costimulation Activity Blockade [PE],Selective T Cell Costimulation Blocker [EPC],CD80-directed Antibody Interactions [MoA],CD86-directed Antibody Interactions [MoA] 0003-0494_d4b32ead-3b1e-48ae-8713-c967fd81b15f 0003-0494 HUMAN PRESCRIPTION DRUG KENALOG-10 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL 20090601 NDA NDA012041 E.R. Squibb & Sons, L.L.C. TRIAMCINOLONE ACETONIDE 10 mg/mL 0003-0524_fb30247e-9d1b-4225-b276-5e789493b9f6 0003-0524 HUMAN PRESCRIPTION DRUG SPRYCEL dasatinib TABLET ORAL 20060627 NDA NDA021986 E.R. Squibb & Sons, L.L.C. DASATINIB 70 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0003-0527_fb30247e-9d1b-4225-b276-5e789493b9f6 0003-0527 HUMAN PRESCRIPTION DRUG SPRYCEL dasatinib TABLET ORAL 20060627 NDA NDA021986 E.R. Squibb & Sons, L.L.C. DASATINIB 20 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0003-0528_fb30247e-9d1b-4225-b276-5e789493b9f6 0003-0528 HUMAN PRESCRIPTION DRUG SPRYCEL dasatinib TABLET ORAL 20060627 NDA NDA021986 E.R. Squibb & Sons, L.L.C. DASATINIB 50 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0003-0830_e5ba67cd-b04d-4a13-a3f1-b13149b724d8 0003-0830 HUMAN PRESCRIPTION DRUG HYDREA HYDROXYUREA CAPSULE ORAL 20090601 NDA NDA016295 E.R. Squibb & Sons, L.L.C. HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] 0003-0852_fb30247e-9d1b-4225-b276-5e789493b9f6 0003-0852 HUMAN PRESCRIPTION DRUG SPRYCEL dasatinib TABLET ORAL 20080530 NDA NDA021986 E.R. Squibb & Sons, L.L.C. DASATINIB 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0003-0855_fb30247e-9d1b-4225-b276-5e789493b9f6 0003-0855 HUMAN PRESCRIPTION DRUG SPRYCEL dasatinib TABLET ORAL 20101028 NDA NDA021986 E.R. Squibb & Sons, L.L.C. DASATINIB 80 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0003-0857_fb30247e-9d1b-4225-b276-5e789493b9f6 0003-0857 HUMAN PRESCRIPTION DRUG SPRYCEL dasatinib TABLET ORAL 20101028 NDA NDA021986 E.R. Squibb & Sons, L.L.C. DASATINIB 140 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0003-0893_7e83ade1-86b1-465c-84ba-7694a1b65acc 0003-0893 HUMAN PRESCRIPTION DRUG ELIQUIS apixaban TABLET, FILM COATED ORAL 20121228 NDA NDA202155 E.R. Squibb & Sons, L.L.C. APIXABAN 2.5 mg/1 Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 0003-0894_7e83ade1-86b1-465c-84ba-7694a1b65acc 0003-0894 HUMAN PRESCRIPTION DRUG ELIQUIS apixaban TABLET, FILM COATED ORAL 20121228 NDA NDA202155 E.R. Squibb & Sons, L.L.C. APIXABAN 5 mg/1 Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 0003-1427_9867963c-f0d9-4b4e-8d6e-6fc901df56eb 0003-1427 HUMAN PRESCRIPTION DRUG FARXIGA DAPAGLIFLOZIN TABLET, FILM COATED ORAL 20140108 NDA NDA202293 E.R. Squibb & Sons, L.L.C. DAPAGLIFLOZIN PROPANEDIOL 5 mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA] 0003-1428_9867963c-f0d9-4b4e-8d6e-6fc901df56eb 0003-1428 HUMAN PRESCRIPTION DRUG FARXIGA DAPAGLIFLOZIN TABLET, FILM COATED ORAL 20140108 NDA NDA202293 E.R. Squibb & Sons, L.L.C. DAPAGLIFLOZIN PROPANEDIOL 10 mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA] 0003-1611_473ee8b2-cf23-41af-984a-519971f6f81e 0003-1611 HUMAN PRESCRIPTION DRUG BARACLUDE entecavir TABLET, FILM COATED ORAL 20050329 NDA NDA021797 E.R. Squibb & Sons, L.L.C. ENTECAVIR .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0003-1612_473ee8b2-cf23-41af-984a-519971f6f81e 0003-1612 HUMAN PRESCRIPTION DRUG BARACLUDE entecavir TABLET, FILM COATED ORAL 20050329 NDA NDA021797 E.R. Squibb & Sons, L.L.C. ENTECAVIR 1 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0003-1614_473ee8b2-cf23-41af-984a-519971f6f81e 0003-1614 HUMAN PRESCRIPTION DRUG BARACLUDE entecavir SOLUTION ORAL 20050329 NDA NDA021798 E.R. Squibb & Sons, L.L.C. ENTECAVIR .05 mg/mL Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0003-1964_a2d79a48-429f-41d0-b0e0-6ae41fdd6b4e 0003-1964 HUMAN PRESCRIPTION DRUG ZERIT Stavudine CAPSULE, GELATIN COATED ORAL 19940624 NDA NDA020412 E.R. Squibb & Sons, L.L.C. STAVUDINE 15 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0003-1965_a2d79a48-429f-41d0-b0e0-6ae41fdd6b4e 0003-1965 HUMAN PRESCRIPTION DRUG ZERIT stavudine CAPSULE, GELATIN COATED ORAL 19940624 NDA NDA020412 E.R. Squibb & Sons, L.L.C. STAVUDINE 20 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0003-1966_a2d79a48-429f-41d0-b0e0-6ae41fdd6b4e 0003-1966 HUMAN PRESCRIPTION DRUG ZERIT stavudine CAPSULE, GELATIN COATED ORAL 19940624 NDA NDA020412 E.R. Squibb & Sons, L.L.C. STAVUDINE 30 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0003-1967_a2d79a48-429f-41d0-b0e0-6ae41fdd6b4e 0003-1967 HUMAN PRESCRIPTION DRUG ZERIT stavudine CAPSULE, GELATIN COATED ORAL 19940624 NDA NDA020412 E.R. Squibb & Sons, L.L.C. STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0003-1968_a2d79a48-429f-41d0-b0e0-6ae41fdd6b4e 0003-1968 HUMAN PRESCRIPTION DRUG ZERIT stavudine POWDER, FOR SOLUTION ORAL 19960906 NDA NDA020413 E.R. Squibb & Sons, L.L.C. STAVUDINE 1 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0003-2187_768ebc34-4474-4f89-9674-15fb91307e67 0003-2187 HUMAN PRESCRIPTION DRUG ORENCIA abatacept INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090101 BLA BLA125118 E.R. Squibb & Sons, L.L.C. ABATACEPT 250 mg/15mL Decreased Cytokine Activity [PE],Selective T Cell Costimulation Modulator [EPC],Recombinant Fusion Proteins [Chemical/Ingredient] 0003-2188_768ebc34-4474-4f89-9674-15fb91307e67 0003-2188 HUMAN PRESCRIPTION DRUG ORENCIA abatacept INJECTION, SOLUTION SUBCUTANEOUS 20110729 BLA BLA125118 E.R. Squibb & Sons, L.L.C. ABATACEPT 125 mg/mL Decreased Cytokine Activity [PE],Selective T Cell Costimulation Modulator [EPC],Recombinant Fusion Proteins [Chemical/Ingredient] 0003-2230_66c3b04a-c7ec-4784-a515-2f5601c648ba 0003-2230 HUMAN PRESCRIPTION DRUG AZACTAM AZTREONAM INJECTION, SOLUTION INTRAVENOUS 20100401 NDA NDA050632 E.R. Squibb & Sons, L.L.C. AZTREONAM 1 g/50mL Monobactam Antibacterial [EPC],Monobactams [Chemical/Ingredient] 0003-2240_66c3b04a-c7ec-4784-a515-2f5601c648ba 0003-2240 HUMAN PRESCRIPTION DRUG AZACTAM AZTREONAM INJECTION, SOLUTION INTRAVENOUS 20100401 NDA NDA050632 E.R. Squibb & Sons, L.L.C. AZTREONAM 2 g/50mL Monobactam Antibacterial [EPC],Monobactams [Chemical/Ingredient] 0003-2327_58fbcd6c-86c2-4e6f-be1a-0331132e2d87 0003-2327 HUMAN PRESCRIPTION DRUG YERVOY ipilimumab INJECTION INTRAVENOUS 20110325 BLA BLA125377 E.R. Squibb & Sons, L.L.C. IPILIMUMAB 5 mg/mL CTLA-4-directed Blocking Antibody [EPC],CTLA-4-directed Antibody Interactions [MoA],Increased T Lymphocyte Activation [PE] 0003-2328_58fbcd6c-86c2-4e6f-be1a-0331132e2d87 0003-2328 HUMAN PRESCRIPTION DRUG YERVOY ipilimumab INJECTION INTRAVENOUS 20110325 BLA BLA125377 E.R. Squibb & Sons, L.L.C. IPILIMUMAB 5 mg/mL CTLA-4-directed Blocking Antibody [EPC],CTLA-4-directed Antibody Interactions [MoA],Increased T Lymphocyte Activation [PE] 0003-2560_a5fce801-f057-467e-ac01-a2966f9c76dd 0003-2560 HUMAN PRESCRIPTION DRUG AZACTAM AZTREONAM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100401 NDA NDA050580 E.R. Squibb & Sons, L.L.C. AZTREONAM 1 g/1 Monobactam Antibacterial [EPC],Monobactams [Chemical/Ingredient] 0003-2570_a5fce801-f057-467e-ac01-a2966f9c76dd 0003-2570 HUMAN PRESCRIPTION DRUG AZACTAM AZTREONAM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100401 NDA NDA050580 E.R. Squibb & Sons, L.L.C. AZTREONAM 2 g/1 Monobactam Antibacterial [EPC],Monobactams [Chemical/Ingredient] 0003-3622_4d969fef-ec40-44c7-9852-8c820924edd2 0003-3622 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20030624 NDA NDA021567 E.R. Squibb & Sons, L.L.C. ATAZANAVIR SULFATE 300 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 0003-3623_4d969fef-ec40-44c7-9852-8c820924edd2 0003-3623 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20030624 20150731 NDA NDA021567 E.R. Squibb & Sons, L.L.C. ATAZANAVIR SULFATE 100 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 0003-3624_4d969fef-ec40-44c7-9852-8c820924edd2 0003-3624 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20030624 NDA NDA021567 E.R. Squibb & Sons, L.L.C. ATAZANAVIR SULFATE 150 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 0003-3631_4d969fef-ec40-44c7-9852-8c820924edd2 0003-3631 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20030624 NDA NDA021567 E.R. Squibb & Sons, L.L.C. ATAZANAVIR SULFATE 200 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 0003-4214_2ce17a7b-7952-42a6-adb3-b669bc6709c7 0003-4214 HUMAN PRESCRIPTION DRUG ONGLYZA SAXAGLIPTIN TABLET, FILM COATED ORAL 20090731 20170430 NDA NDA022350 E.R. Squibb & Sons, L.L.C. SAXAGLIPTIN HYDROCHLORIDE 2.5 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 0003-4215_2ce17a7b-7952-42a6-adb3-b669bc6709c7 0003-4215 HUMAN PRESCRIPTION DRUG ONGLYZA SAXAGLIPTIN TABLET, FILM COATED ORAL 20090731 20170430 NDA NDA022350 E.R. Squibb & Sons, L.L.C. SAXAGLIPTIN HYDROCHLORIDE 5 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 0003-4221_c6216adf-3a9a-424c-8ae1-7ed2da42a108 0003-4221 HUMAN PRESCRIPTION DRUG KOMBIGLYZE XR SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101105 NDA NDA200678 E.R. Squibb & Sons, L.L.C. METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 500; 5 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0003-4222_c6216adf-3a9a-424c-8ae1-7ed2da42a108 0003-4222 HUMAN PRESCRIPTION DRUG KOMBIGLYZE XR SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101105 NDA NDA200678 E.R. Squibb & Sons, L.L.C. METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 1000; 2.5 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0003-4223_c6216adf-3a9a-424c-8ae1-7ed2da42a108 0003-4223 HUMAN PRESCRIPTION DRUG KOMBIGLYZE XR SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101105 NDA NDA200678 E.R. Squibb & Sons, L.L.C. METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 1000; 5 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0003-5178_1df7e691-9b98-43a9-ac46-24fa96652062 0003-5178 HUMAN PRESCRIPTION DRUG PRAVACHOL PRAVASTATIN SODIUM TABLET ORAL 20090601 NDA NDA019898 E.R. Squibb & Sons, L.L.C. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0003-5194_1df7e691-9b98-43a9-ac46-24fa96652062 0003-5194 HUMAN PRESCRIPTION DRUG PRAVACHOL PRAVASTATIN SODIUM TABLET ORAL 20090601 NDA NDA019898 E.R. Squibb & Sons, L.L.C. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0003-5195_1df7e691-9b98-43a9-ac46-24fa96652062 0003-5195 HUMAN PRESCRIPTION DRUG PRAVACHOL PRAVASTATIN SODIUM TABLET ORAL 20090601 NDA NDA019898 E.R. Squibb & Sons, L.L.C. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0003-6335_5570c6a4-8c9e-4cba-8d34-7b6fc656b05b 0003-6335 HUMAN PRESCRIPTION DRUG DROXIA HYDROXYUREA CAPSULE ORAL 20090601 NDA NDA016295 E.R. Squibb & Sons, L.L.C. HYDROXYUREA 200 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] 0003-6336_5570c6a4-8c9e-4cba-8d34-7b6fc656b05b 0003-6336 HUMAN PRESCRIPTION DRUG DROXIA HYDROXYUREA CAPSULE ORAL 20090601 NDA NDA016295 E.R. Squibb & Sons, L.L.C. HYDROXYUREA 300 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] 0003-6337_5570c6a4-8c9e-4cba-8d34-7b6fc656b05b 0003-6337 HUMAN PRESCRIPTION DRUG DROXIA HYDROXYUREA CAPSULE ORAL 20090601 NDA NDA016295 E.R. Squibb & Sons, L.L.C. HYDROXYUREA 400 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] 0004-0028_e3d235c8-7147-4db6-a358-2b973a3c479a 0004-0028 HUMAN PRESCRIPTION DRUG Naprosyn naproxen SUSPENSION ORAL 19870323 NDA NDA018965 Genentech, Inc. NAPROXEN 125 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0004-0038_c2591f0f-0e36-4867-9ac7-a3d10b9ad644 0004-0038 HUMAN PRESCRIPTION DRUG Valcyte valganciclovir hydrochloride TABLET, FILM COATED ORAL 20010329 NDA NDA021304 Genentech, Inc. VALGANCICLOVIR HYDROCHLORIDE 450 mg/1 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 0004-0039_c2591f0f-0e36-4867-9ac7-a3d10b9ad644 0004-0039 HUMAN PRESCRIPTION DRUG Valcyte valganciclovir hydrochloride POWDER, FOR SOLUTION ORAL 20090828 NDA NDA022257 Genentech, Inc. VALGANCICLOVIR HYDROCHLORIDE 50 mg/mL Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 0004-0058_6f0237c8-528e-4fd7-b05b-34801a6a3ed6 0004-0058 HUMAN PRESCRIPTION DRUG Klonopin Clonazepam TABLET ORAL 19750602 NDA NDA017533 Genentech, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0004-0068_6f0237c8-528e-4fd7-b05b-34801a6a3ed6 0004-0068 HUMAN PRESCRIPTION DRUG Klonopin Clonazepam TABLET ORAL 19750602 NDA NDA017533 Genentech, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0004-0086_9ec9b0cd-93ef-45d8-8d4b-54583a5b8323 0004-0086 HUMAN PRESCRIPTION DRUG Copegus Ribavirin TABLET, FILM COATED ORAL 20021203 NDA NDA021511 Genentech, Inc. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 0004-0098_6f0237c8-528e-4fd7-b05b-34801a6a3ed6 0004-0098 HUMAN PRESCRIPTION DRUG Klonopin Clonazepam TABLET ORAL 19750602 NDA NDA017533 Genentech, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0004-0186_c2d4ad91-60cb-48a1-8142-852a54db154d 0004-0186 HUMAN PRESCRIPTION DRUG Boniva ibandronate sodium TABLET, FILM COATED ORAL 20020715 NDA NDA021455 Genentech, Inc. IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0004-0191_f80c3913-a660-4c74-8f16-3634da971f9b 0004-0191 HUMAN PRESCRIPTION DRUG Boniva ibandronate sodium INJECTION, SOLUTION INTRAVENOUS 20110601 NDA NDA021858 Genentech, Inc. IBANDRONATE SODIUM 3 mg/3mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0004-0244_a0d54641-f23e-4f2b-a24f-dcc8dacdf59c 0004-0244 HUMAN PRESCRIPTION DRUG Invirase saquinavir mesylate TABLET, FILM COATED ORAL 20041217 NDA NDA021785 Genentech, Inc. SAQUINAVIR MESYLATE 500 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 0004-0245_a0d54641-f23e-4f2b-a24f-dcc8dacdf59c 0004-0245 HUMAN PRESCRIPTION DRUG Invirase saquinavir mesylate CAPSULE ORAL 19951206 NDA NDA020628 Genentech, Inc. SAQUINAVIR MESYLATE 200 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 0004-0257_23c3db3e-039e-4291-9769-7093b5cc486b 0004-0257 HUMAN PRESCRIPTION DRUG Xenical orlistat CAPSULE ORAL 20101217 NDA NDA020766 Genentech, Inc. ORLISTAT 120 mg/1 Intestinal Lipase Inhibitor [EPC],Lipase Inhibitors [MoA] 0004-0259_a4b76f4b-ba8a-42c7-93ba-1c3935836a58 0004-0259 HUMAN PRESCRIPTION DRUG CellCept Mycophenolate Mofetil CAPSULE ORAL 19950503 NDA NDA050722 Genentech, Inc. MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 0004-0260_a4b76f4b-ba8a-42c7-93ba-1c3935836a58 0004-0260 HUMAN PRESCRIPTION DRUG CellCept Mycophenolate Mofetil TABLET, FILM COATED ORAL 19970619 NDA NDA050723 Genentech, Inc. MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 0004-0261_a4b76f4b-ba8a-42c7-93ba-1c3935836a58 0004-0261 HUMAN PRESCRIPTION DRUG CellCept Mycophenolate Mofetil POWDER, FOR SUSPENSION ORAL 19980812 NDA NDA050759 Genentech, Inc. MYCOPHENOLATE MOFETIL 200 mg/mL Antimetabolite Immunosuppressant [EPC] 0004-0298_a4b76f4b-ba8a-42c7-93ba-1c3935836a58 0004-0298 HUMAN PRESCRIPTION DRUG CellCept Mycophenolate Mofetil hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19981001 NDA NDA050758 Genentech, Inc. MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500 mg/20mL Antimetabolite Immunosuppressant [EPC] 0004-0350_d9af3189-1bec-44b8-841c-e96471bb01dd 0004-0350 HUMAN PRESCRIPTION DRUG Pegasys peginterferon alfa-2a INJECTION, SOLUTION SUBCUTANEOUS 20021016 BLA BLA103964 Genentech, Inc. PEGINTERFERON ALFA-2A 180 ug/mL Interferon alpha [EPC],peginterferon alfa-2a [Chemical/Ingredient] 0004-0357_d9af3189-1bec-44b8-841c-e96471bb01dd 0004-0357 HUMAN PRESCRIPTION DRUG Pegasys peginterferon alfa-2a INJECTION, SOLUTION SUBCUTANEOUS 20110329 BLA BLA103964 Genentech, Inc. PEGINTERFERON ALFA-2A 180 ug/.5mL Interferon alpha [EPC],peginterferon alfa-2a [Chemical/Ingredient] 0004-0360_d9af3189-1bec-44b8-841c-e96471bb01dd 0004-0360 HUMAN PRESCRIPTION DRUG Pegasys peginterferon alfa-2a INJECTION, SOLUTION SUBCUTANEOUS 20111101 BLA BLA103964 Genentech, Inc. PEGINTERFERON ALFA-2A 135 ug/.5mL Interferon alpha [EPC],peginterferon alfa-2a [Chemical/Ingredient] 0004-0365_d9af3189-1bec-44b8-841c-e96471bb01dd 0004-0365 HUMAN PRESCRIPTION DRUG Pegasys peginterferon alfa-2a INJECTION, SOLUTION SUBCUTANEOUS 20111101 BLA BLA103964 Genentech, Inc. PEGINTERFERON ALFA-2A 180 ug/.5mL Interferon alpha [EPC],peginterferon alfa-2a [Chemical/Ingredient] 0004-0381_0927a327-ce61-4513-bff8-3f42b4dbdd2e 0004-0381 HUMAN PRESCRIPTION DRUG FUZEON Enfuvirtide KIT 20120410 NDA NDA021481 Genentech, Inc. 0004-0401_08812f0a-9569-482c-ba8e-152b8bd2dde8 0004-0401 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 BLA BLA125164 Genentech, Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 50 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 0004-0402_08812f0a-9569-482c-ba8e-152b8bd2dde8 0004-0402 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 BLA BLA125164 Genentech, Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 75 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 0004-0403_08812f0a-9569-482c-ba8e-152b8bd2dde8 0004-0403 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 BLA BLA125164 Genentech, Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 100 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 0004-0404_08812f0a-9569-482c-ba8e-152b8bd2dde8 0004-0404 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 BLA BLA125164 Genentech, Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 150 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 0004-0405_08812f0a-9569-482c-ba8e-152b8bd2dde8 0004-0405 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 BLA BLA125164 Genentech, Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 200 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 0004-0406_08812f0a-9569-482c-ba8e-152b8bd2dde8 0004-0406 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 BLA BLA125164 Genentech, Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 250 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 0004-0800_1820a01b-1929-4b64-b230-5f8c3a3bb74f 0004-0800 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 19991027 NDA NDA021087 Genentech, Inc. OSELTAMIVIR PHOSPHATE 75 mg/1 0004-0801_1820a01b-1929-4b64-b230-5f8c3a3bb74f 0004-0801 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 19991027 NDA NDA021087 Genentech, Inc. OSELTAMIVIR PHOSPHATE 45 mg/1 0004-0802_1820a01b-1929-4b64-b230-5f8c3a3bb74f 0004-0802 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 19991027 NDA NDA021087 Genentech, Inc. OSELTAMIVIR PHOSPHATE 30 mg/1 0004-0822_1820a01b-1929-4b64-b230-5f8c3a3bb74f 0004-0822 HUMAN PRESCRIPTION DRUG Tamiflu Oseltamivir Phosphate POWDER, FOR SUSPENSION ORAL 20130801 NDA NDA021246 Genentech, Inc. OSELTAMIVIR PHOSPHATE 6 mg/mL 0004-1100_aae6e1f7-909f-49d9-90b3-2c959464d77f 0004-1100 HUMAN PRESCRIPTION DRUG Xeloda capecitabine TABLET, FILM COATED ORAL 19980430 NDA NDA020896 Genentech, Inc. CAPECITABINE 150 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0004-1101_aae6e1f7-909f-49d9-90b3-2c959464d77f 0004-1101 HUMAN PRESCRIPTION DRUG Xeloda capecitabine TABLET, FILM COATED ORAL 19980430 NDA NDA020896 Genentech, Inc. CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0004-1963_86e3103c-9d8b-4693-b5db-3fd62330c754 0004-1963 HUMAN PRESCRIPTION DRUG Rocephin ceftriaxone sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19930813 ANDA ANDA063239 Genentech, Inc. CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0004-1964_86e3103c-9d8b-4693-b5db-3fd62330c754 0004-1964 HUMAN PRESCRIPTION DRUG Rocephin ceftriaxone sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19930813 ANDA ANDA063239 Genentech, Inc. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0004-6202_e3d235c8-7147-4db6-a358-2b973a3c479a 0004-6202 HUMAN PRESCRIPTION DRUG Anaprox naproxen sodium TABLET ORAL 19800904 NDA NDA018164 Genentech, Inc. NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0004-6203_e3d235c8-7147-4db6-a358-2b973a3c479a 0004-6203 HUMAN PRESCRIPTION DRUG Anaprox DS naproxen sodium TABLET ORAL 19800904 NDA NDA018164 Genentech, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0004-6313_e3d235c8-7147-4db6-a358-2b973a3c479a 0004-6313 HUMAN PRESCRIPTION DRUG Naprosyn naproxen TABLET ORAL 19760311 NDA NDA017581 Genentech, Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0004-6314_e3d235c8-7147-4db6-a358-2b973a3c479a 0004-6314 HUMAN PRESCRIPTION DRUG Naprosyn naproxen TABLET ORAL 19760311 NDA NDA017581 Genentech, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0004-6316_e3d235c8-7147-4db6-a358-2b973a3c479a 0004-6316 HUMAN PRESCRIPTION DRUG Naprosyn naproxen TABLET ORAL 19760311 NDA NDA017581 Genentech, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0004-6415_e3d235c8-7147-4db6-a358-2b973a3c479a 0004-6415 HUMAN PRESCRIPTION DRUG EC-Naprosyn naproxen TABLET, DELAYED RELEASE ORAL 19941014 NDA NDA020067 Genentech, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0004-6416_e3d235c8-7147-4db6-a358-2b973a3c479a 0004-6416 HUMAN PRESCRIPTION DRUG EC-Naprosyn naproxen TABLET, DELAYED RELEASE ORAL 19941014 NDA NDA020067 Genentech, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0004-6940_484024de-e593-46db-aec2-ce1276432822 0004-6940 HUMAN PRESCRIPTION DRUG Cytovene IV ganciclovir sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19890623 NDA NDA019661 Genentech, Inc. GANCICLOVIR SODIUM 500 mg/10mL Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 0005-0100_4a20370a-121f-475b-bb77-32eaf1e6de01 0005-0100 VACCINE Trumenba meningococcal group B vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20141105 BLA BLA125549 Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, a subsidiary of Pfizer Inc. NEISSERIA MENINGITIDIS SEROGROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN; NEISSERIA MENINGITIDIS SEROGROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN 60; 60 ug/.5mL; ug/.5mL 0005-1970_5702cded-2182-1089-765f-b00d10bcce62 0005-1970 VACCINE Prevnar Pneumococcal 7-valent INJECTION, SUSPENSION INTRAMUSCULAR 20000301 BLA BLA103905 Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, a subsidiary of Pfizer Inc. STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2; 2; 2; 2; 2; 4; 2 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Conjugate [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient] 0005-1971_cf5e8314-68f7-418d-8113-7e7c5ac35eca 0005-1971 VACCINE PREVNAR 13 pneumococcal 13-valent conjugate vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20100312 BLA BLA125324 Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, a subsidiary of Pfizer Inc. STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 4.4; 2.2; 2.2 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Conjugate [Chemical/Ingredient] 0005-2500_ffb6c98d-e53e-474b-a4c6-1bc7f02b90bb 0005-2500 HUMAN OTC DRUG FIBERCON CALCIUM POLYCARBOPHIL TABLET ORAL 20040105 OTC MONOGRAPH NOT FINAL part334 Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, a subsidiary of Pfizer Inc. CALCIUM POLYCARBOPHIL 625 mg/1 0006-0005_7075c923-6704-44f8-8ae5-c55639bb735b 0006-0005 HUMAN PRESCRIPTION DRUG BELSOMRA suvorexant TABLET, FILM COATED ORAL 20140829 NDA NDA204569 Merck Sharp & Dohme Corp. SUVOREXANT 5 mg/1 CIV 0006-0019_a790b9b2-98ce-4a21-9f62-c1efe3850054 0006-0019 HUMAN PRESCRIPTION DRUG PRINIVIL lisinopril TABLET ORAL 19871229 NDA NDA019558 Merck Sharp & Dohme Corp. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0006-0031_52cfcb3c-56c4-48ff-ac22-3cdf02d7bf58 0006-0031 HUMAN PRESCRIPTION DRUG FOSAMAX alendronate sodium TABLET ORAL 19950929 NDA NDA020560 Merck Sharp & Dohme Corp. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0006-0032_1bd71a49-88a0-4a58-8d78-13bd07871f6c 0006-0032 HUMAN PRESCRIPTION DRUG STROMECTOL ivermectin TABLET ORAL 19961122 NDA NDA050742 Merck Sharp & Dohme Corp. IVERMECTIN 3 mg/1 Antiparasitic [EPC],Pediculicide [EPC] 0006-0033_7075c923-6704-44f8-8ae5-c55639bb735b 0006-0033 HUMAN PRESCRIPTION DRUG BELSOMRA suvorexant TABLET, FILM COATED ORAL 20140829 NDA NDA204569 Merck Sharp & Dohme Corp. SUVOREXANT 10 mg/1 CIV 0006-0071_c32453b1-1683-4fe8-bbf5-dba927966729 0006-0071 HUMAN PRESCRIPTION DRUG PROPECIA finasteride TABLET, FILM COATED ORAL 19971219 NDA NDA020788 Merck Sharp & Dohme Corp. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 0006-0072_788fb676-fff1-42c0-8d6f-000bd8183c78 0006-0072 HUMAN PRESCRIPTION DRUG PROSCAR FINASTERIDE TABLET, FILM COATED ORAL 19920619 NDA NDA020180 Merck Sharp & Dohme Corp. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 0006-0078_25d4dfc2-860d-4eb1-8403-5de0b7293e67 0006-0078 HUMAN PRESCRIPTION DRUG JANUMET XR sitagliptin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120202 NDA NDA202270 Merck Sharp & Dohme Corp. METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 500; 50 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0006-0080_25d4dfc2-860d-4eb1-8403-5de0b7293e67 0006-0080 HUMAN PRESCRIPTION DRUG JANUMET XR sitagliptin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120202 NDA NDA202270 Merck Sharp & Dohme Corp. METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 1000; 50 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0006-0081_25d4dfc2-860d-4eb1-8403-5de0b7293e67 0006-0081 HUMAN PRESCRIPTION DRUG JANUMET XR sitagliptin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120202 NDA NDA202270 Merck Sharp & Dohme Corp. METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 1000; 100 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0006-0106_a790b9b2-98ce-4a21-9f62-c1efe3850054 0006-0106 HUMAN PRESCRIPTION DRUG PRINIVIL lisinopril TABLET ORAL 19871229 NDA NDA019558 Merck Sharp & Dohme Corp. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0006-0112_a37dabd5-fb11-4691-a3be-238a398895ae 0006-0112 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20061016 NDA NDA021995 Merck Sharp & Dohme Corp. SITAGLIPTIN PHOSPHATE 50 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 0006-0207_a790b9b2-98ce-4a21-9f62-c1efe3850054 0006-0207 HUMAN PRESCRIPTION DRUG PRINIVIL lisinopril TABLET ORAL 19871229 NDA NDA019558 Merck Sharp & Dohme Corp. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0006-0221_a37dabd5-fb11-4691-a3be-238a398895ae 0006-0221 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20061016 NDA NDA021995 Merck Sharp & Dohme Corp. SITAGLIPTIN PHOSPHATE 25 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 0006-0227_1894af42-fece-4d87-93f1-e562c4481e80 0006-0227 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, FILM COATED ORAL 20071012 NDA NDA022145 Merck Sharp & Dohme Corp. RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] 0006-0266_a21a1340-aa80-48e5-a4ad-9e85c2e4a37e 0006-0266 HUMAN PRESCRIPTION DRUG MAXALT rizatriptan benzoate TABLET ORAL 19980629 NDA NDA020864 Merck Sharp & Dohme Corp. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0006-0267_a21a1340-aa80-48e5-a4ad-9e85c2e4a37e 0006-0267 HUMAN PRESCRIPTION DRUG MAXALT rizatriptan benzoate TABLET ORAL 19980629 NDA NDA020864 Merck Sharp & Dohme Corp. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0006-0270_a8546eb0-6ee5-40ad-ad42-6d08425dcd9b 0006-0270 HUMAN PRESCRIPTION DRUG FOSAMAX PLUS D ALENDRONATE SODIUM and CHOLECALCIFEROL TABLET ORAL 20050407 NDA NDA021762 Merck Sharp & Dohme Corp. ALENDRONATE SODIUM; CHOLECALCIFEROL 70; 5600 mg/1; [iU]/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0006-0275_7a0ed70f-3343-407c-9823-6bd237598c45 0006-0275 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 19980220 NDA NDA020830 Merck Sharp & Dohme Corp. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0006-0277_a37dabd5-fb11-4691-a3be-238a398895ae 0006-0277 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20061016 NDA NDA021995 Merck Sharp & Dohme Corp. SITAGLIPTIN PHOSPHATE 100 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 0006-0325_7075c923-6704-44f8-8ae5-c55639bb735b 0006-0325 HUMAN PRESCRIPTION DRUG BELSOMRA suvorexant TABLET, FILM COATED ORAL 20140829 NDA NDA204569 Merck Sharp & Dohme Corp. SUVOREXANT 15 mg/1 CIV 0006-0335_7075c923-6704-44f8-8ae5-c55639bb735b 0006-0335 HUMAN PRESCRIPTION DRUG BELSOMRA suvorexant TABLET, FILM COATED ORAL 20140829 NDA NDA204569 Merck Sharp & Dohme Corp. SUVOREXANT 20 mg/1 CIV 0006-0351_34d5e7aa-7c18-4046-ba13-3ec17b61c262 0006-0351 HUMAN PRESCRIPTION DRUG ZONTIVITY vorapaxar TABLET, FILM COATED ORAL 20140508 NDA NDA204886 Merck Sharp & Dohme Corp. VORAPAXAR SULFATE 2.08 mg/1 0006-0461_0f22cf2c-09b7-4a19-89fc-6b25b15e9241 0006-0461 HUMAN PRESCRIPTION DRUG EMEND aprepitant CAPSULE ORAL 20030326 NDA NDA021549 Merck Sharp & Dohme Corp. APREPITANT 80 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA] 0006-0462_0f22cf2c-09b7-4a19-89fc-6b25b15e9241 0006-0462 HUMAN PRESCRIPTION DRUG EMEND aprepitant CAPSULE ORAL 20030326 NDA NDA021549 Merck Sharp & Dohme Corp. APREPITANT 125 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA] 0006-0464_0f22cf2c-09b7-4a19-89fc-6b25b15e9241 0006-0464 HUMAN PRESCRIPTION DRUG EMEND aprepitant CAPSULE ORAL 20030326 NDA NDA021549 Merck Sharp & Dohme Corp. APREPITANT 40 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA] 0006-0473_1894af42-fece-4d87-93f1-e562c4481e80 0006-0473 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, CHEWABLE ORAL 20111221 NDA NDA203045 Merck Sharp & Dohme Corp. RALTEGRAVIR POTASSIUM 25 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] 0006-0477_1894af42-fece-4d87-93f1-e562c4481e80 0006-0477 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, CHEWABLE ORAL 20111221 NDA NDA203045 Merck Sharp & Dohme Corp. RALTEGRAVIR POTASSIUM 100 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] 0006-0533_c41b4a12-6504-4fe8-abbe-e7f3ba0d28e2 0006-0533 HUMAN PRESCRIPTION DRUG JUVISYNC SITAGLIPTIN and SIMVASTATIN TABLET, FILM COATED ORAL 20120918 NDA NDA202343 Merck Sharp & Dohme Corp. SIMVASTATIN; SITAGLIPTIN PHOSPHATE 10; 50 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0006-0535_c41b4a12-6504-4fe8-abbe-e7f3ba0d28e2 0006-0535 HUMAN PRESCRIPTION DRUG JUVISYNC SITAGLIPTIN and SIMVASTATIN TABLET, FILM COATED ORAL 20120918 NDA NDA202343 Merck Sharp & Dohme Corp. SIMVASTATIN; SITAGLIPTIN PHOSPHATE 20; 50 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0006-0537_c41b4a12-6504-4fe8-abbe-e7f3ba0d28e2 0006-0537 HUMAN PRESCRIPTION DRUG JUVISYNC SITAGLIPTIN and SIMVASTATIN TABLET, FILM COATED ORAL 20120918 NDA NDA202343 Merck Sharp & Dohme Corp. SIMVASTATIN; SITAGLIPTIN PHOSPHATE 40; 50 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0006-0543_e0d845b5-f301-4215-aabf-05c7b1d65e88 0006-0543 HUMAN PRESCRIPTION DRUG ZOCOR SIMVASTATIN TABLET, FILM COATED ORAL 19911223 NDA NDA019766 Merck Sharp & Dohme Corp. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0006-0568_296e188c-87ab-47fa-b2e8-ca8020733991 0006-0568 HUMAN PRESCRIPTION DRUG ZOLINZA vorinostat CAPSULE ORAL 20061006 NDA NDA021991 Merck Sharp & Dohme Corp. VORINOSTAT 100 mg/1 Histone Deacetylase Inhibitor [EPC],Histone Deacetylase Inhibitors [MoA] 0006-0571_a0914204-b6d4-4b46-8fa3-951d3619d3eb 0006-0571 HUMAN PRESCRIPTION DRUG CRIXIVAN indinavir sulfate CAPSULE ORAL 19960313 NDA NDA020685 Merck Sharp & Dohme Corp. INDINAVIR SULFATE 200 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 0006-0573_a0914204-b6d4-4b46-8fa3-951d3619d3eb 0006-0573 HUMAN PRESCRIPTION DRUG CRIXIVAN indinavir sulfate CAPSULE ORAL 19960313 NDA NDA020685 Merck Sharp & Dohme Corp. INDINAVIR SULFATE 400 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 0006-0575_6fae19ff-435a-4e5c-a42f-a024bae6950f 0006-0575 HUMAN PRESCRIPTION DRUG JANUMET SITAGLIPTIN and METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20070330 NDA NDA022044 Merck Sharp & Dohme Corp. METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 500; 50 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0006-0577_6fae19ff-435a-4e5c-a42f-a024bae6950f 0006-0577 HUMAN PRESCRIPTION DRUG JANUMET SITAGLIPTIN and METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20070330 NDA NDA022044 Merck Sharp & Dohme Corp. METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 1000; 50 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0006-0705_d385a6c4-00a4-41c2-be82-f9799e0e2e9d 0006-0705 HUMAN PRESCRIPTION DRUG NOROXIN Norfloxacin TABLET, FILM COATED ORAL 19861031 NDA NDA019384 Merck Sharp & Dohme Corp. NORFLOXACIN 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0006-0710_a8546eb0-6ee5-40ad-ad42-6d08425dcd9b 0006-0710 HUMAN PRESCRIPTION DRUG FOSAMAX PLUS D ALENDRONATE SODIUM and CHOLECALCIFEROL TABLET ORAL 20050407 NDA NDA021762 Merck Sharp & Dohme Corp. ALENDRONATE SODIUM; CHOLECALCIFEROL 70; 2800 mg/1; [iU]/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0006-0711_7a0ed70f-3343-407c-9823-6bd237598c45 0006-0711 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 19980220 NDA NDA020830 Merck Sharp & Dohme Corp. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0006-0717_65b2a0bb-fa62-42ee-821d-aa6528484a4c 0006-0717 HUMAN PRESCRIPTION DRUG HYZAAR losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Merck Sharp & Dohme Corp. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0006-0726_e0d845b5-f301-4215-aabf-05c7b1d65e88 0006-0726 HUMAN PRESCRIPTION DRUG ZOCOR SIMVASTATIN TABLET, FILM COATED ORAL 19911223 NDA NDA019766 Merck Sharp & Dohme Corp. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0006-0731_21e581c7-ce82-4966-8b4c-1dd4b1ef1377 0006-0731 HUMAN PRESCRIPTION DRUG MEVACOR lovastatin TABLET ORAL 19870831 NDA NDA019643 Merck Sharp & Dohme Corp. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0006-0732_21e581c7-ce82-4966-8b4c-1dd4b1ef1377 0006-0732 HUMAN PRESCRIPTION DRUG MEVACOR lovastatin TABLET ORAL 19870831 NDA NDA019643 Merck Sharp & Dohme Corp. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0006-0735_e0d845b5-f301-4215-aabf-05c7b1d65e88 0006-0735 HUMAN PRESCRIPTION DRUG ZOCOR SIMVASTATIN TABLET, FILM COATED ORAL 19911223 NDA NDA019766 Merck Sharp & Dohme Corp. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0006-0740_e0d845b5-f301-4215-aabf-05c7b1d65e88 0006-0740 HUMAN PRESCRIPTION DRUG ZOCOR SIMVASTATIN TABLET, FILM COATED ORAL 19911223 NDA NDA019766 Merck Sharp & Dohme Corp. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0006-0745_65b2a0bb-fa62-42ee-821d-aa6528484a4c 0006-0745 HUMAN PRESCRIPTION DRUG HYZAAR losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Merck Sharp & Dohme Corp. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0006-0747_65b2a0bb-fa62-42ee-821d-aa6528484a4c 0006-0747 HUMAN PRESCRIPTION DRUG HYZAAR losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Merck Sharp & Dohme Corp. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0006-0749_e0d845b5-f301-4215-aabf-05c7b1d65e88 0006-0749 HUMAN PRESCRIPTION DRUG ZOCOR SIMVASTATIN TABLET, FILM COATED ORAL 19911223 NDA NDA019766 Merck Sharp & Dohme Corp. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0006-0753_c41b4a12-6504-4fe8-abbe-e7f3ba0d28e2 0006-0753 HUMAN PRESCRIPTION DRUG JUVISYNC sitagliptin and simvastatin TABLET, FILM COATED ORAL 20111007 NDA NDA202343 Merck Sharp & Dohme Corp. SIMVASTATIN; SITAGLIPTIN PHOSPHATE 10; 100 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0006-0757_c41b4a12-6504-4fe8-abbe-e7f3ba0d28e2 0006-0757 HUMAN PRESCRIPTION DRUG JUVISYNC sitagliptin and simvastatin TABLET, FILM COATED ORAL 20111007 NDA NDA202343 Merck Sharp & Dohme Corp. SIMVASTATIN; SITAGLIPTIN PHOSPHATE 20; 100 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0006-0773_c41b4a12-6504-4fe8-abbe-e7f3ba0d28e2 0006-0773 HUMAN PRESCRIPTION DRUG JUVISYNC sitagliptin and simvastatin TABLET, FILM COATED ORAL 20111007 NDA NDA202343 Merck Sharp & Dohme Corp. SIMVASTATIN; SITAGLIPTIN PHOSPHATE 40; 100 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0006-0951_fdb356ce-b25c-434e-bac8-3e80b4eb0ad9 0006-0951 HUMAN PRESCRIPTION DRUG COZAAR losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Merck Sharp & Dohme Corp. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0006-0952_fdb356ce-b25c-434e-bac8-3e80b4eb0ad9 0006-0952 HUMAN PRESCRIPTION DRUG COZAAR losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Merck Sharp & Dohme Corp. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0006-0960_fdb356ce-b25c-434e-bac8-3e80b4eb0ad9 0006-0960 HUMAN PRESCRIPTION DRUG COZAAR losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Merck Sharp & Dohme Corp. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0006-1711_7a0ed70f-3343-407c-9823-6bd237598c45 0006-1711 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 19980220 NDA NDA020830 Merck Sharp & Dohme Corp. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0006-3029_6b6e18bb-5462-4dea-b41a-ea265ec65499 0006-3029 HUMAN PRESCRIPTION DRUG KEYTRUDA pembrolizumab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140904 BLA BLA125514 Merck Sharp & Dohme Corp. PEMBROLIZUMAB 50 mg/2mL 0006-3395_0dc6d7ff-27f3-44ad-ac61-d0bbb0635d14 0006-3395 HUMAN PRESCRIPTION DRUG AMINOHIPPURATE SODIUM PAH aminohippurate sodium INJECTION, SOLUTION INTRAVENOUS 19441230 NDA NDA005619 Merck Sharp & Dohme Corp. AMINOHIPPURATE SODIUM 2 g/10mL 0006-3514_44394709-c009-4365-a3c4-1b50cd90a841 0006-3514 HUMAN PRESCRIPTION DRUG PRIMAXIN IV imipenem and cilastatin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19851126 NDA NDA050587 Merck Sharp & Dohme Corp. CILASTATIN SODIUM; IMIPENEM 250; 250 mg/100mL; mg/100mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 0006-3516_44394709-c009-4365-a3c4-1b50cd90a841 0006-3516 HUMAN PRESCRIPTION DRUG PRIMAXIN IV imipenem and cilastatin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19851126 NDA NDA050587 Merck Sharp & Dohme Corp. CILASTATIN SODIUM; IMIPENEM 500; 500 mg/100mL; mg/100mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 0006-3519_0ab2a390-2925-4b2c-98d3-24f338eee2c2 0006-3519 HUMAN PRESCRIPTION DRUG TRUSOPT dorzolamide hydrochloride SOLUTION OPHTHALMIC 19941209 NDA NDA020408 Merck Sharp & Dohme Corp. DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] 0006-3551_44394709-c009-4365-a3c4-1b50cd90a841 0006-3551 HUMAN PRESCRIPTION DRUG PRIMAXIN IV imipenem and cilastatin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19870108 ANDA ANDA062756 Merck Sharp & Dohme Corp. CILASTATIN SODIUM; IMIPENEM 250; 250 mg/100mL; mg/100mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 0006-3552_44394709-c009-4365-a3c4-1b50cd90a841 0006-3552 HUMAN PRESCRIPTION DRUG PRIMAXIN IV imipenem and cilastatin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19870108 ANDA ANDA062756 Merck Sharp & Dohme Corp. CILASTATIN SODIUM; IMIPENEM 500; 500 mg/100mL; mg/100mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 0006-3603_1894af42-fece-4d87-93f1-e562c4481e80 0006-3603 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR GRANULE, FOR SUSPENSION ORAL 20131220 NDA NDA203045 Merck Sharp & Dohme Corp. RALTEGRAVIR POTASSIUM 100 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] 0006-3628_0e120c24-ff81-4433-a0bd-c4390047f6bd 0006-3628 HUMAN PRESCRIPTION DRUG COSOPT dorzolamide hydrochloride and timolol maleate SOLUTION OPHTHALMIC 19980407 NDA NDA020869 Merck Sharp & Dohme Corp. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0006-3629_b784342e-91c5-471e-9229-e00c8f708bc8 0006-3629 HUMAN PRESCRIPTION DRUG COSOPT PF DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE SOLUTION OPHTHALMIC 20120201 NDA NDA202667 Merck Sharp & Dohme Corp. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0006-3800_a21a1340-aa80-48e5-a4ad-9e85c2e4a37e 0006-3800 HUMAN PRESCRIPTION DRUG MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 19980629 NDA NDA020865 Merck Sharp & Dohme Corp. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0006-3801_a21a1340-aa80-48e5-a4ad-9e85c2e4a37e 0006-3801 HUMAN PRESCRIPTION DRUG MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 19980629 NDA NDA020865 Merck Sharp & Dohme Corp. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0006-3822_fcf4365c-cd24-4d9b-ba14-a6ce33342763 0006-3822 HUMAN PRESCRIPTION DRUG CANCIDAS CASPOFUNGIN ACETATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010126 NDA NDA021227 Merck Sharp & Dohme Corp. CASPOFUNGIN ACETATE 5 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] 0006-3823_fcf4365c-cd24-4d9b-ba14-a6ce33342763 0006-3823 HUMAN PRESCRIPTION DRUG CANCIDAS CASPOFUNGIN ACETATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010126 NDA NDA021227 Merck Sharp & Dohme Corp. CASPOFUNGIN ACETATE 7 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] 0006-3841_7a0ed70f-3343-407c-9823-6bd237598c45 0006-3841 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium GRANULE ORAL 20020726 NDA NDA021409 Merck Sharp & Dohme Corp. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0006-3843_424b0d88-6662-498a-9aff-68b7bba48d14 0006-3843 HUMAN PRESCRIPTION DRUG INVANZ ertapenem sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20011121 NDA NDA021337 Merck Sharp & Dohme Corp. ERTAPENEM SODIUM 1 g/1 Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 0006-3845_424b0d88-6662-498a-9aff-68b7bba48d14 0006-3845 HUMAN PRESCRIPTION DRUG INVANZ ertapenem sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20011121 NDA NDA021337 Merck Sharp & Dohme Corp. ERTAPENEM SODIUM 1 g/1 Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 0006-3862_0f22cf2c-09b7-4a19-89fc-6b25b15e9241 0006-3862 HUMAN PRESCRIPTION DRUG EMEND aprepitant KIT 20030326 NDA NDA021549 Merck Sharp & Dohme Corp. 0006-3884_380fb104-7b53-49c5-852d-350660f24fb3 0006-3884 HUMAN PRESCRIPTION DRUG EMEND FOSAPREPITANT DIMEGLUMINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080125 NDA NDA022023 Merck Sharp & Dohme Corp. FOSAPREPITANT DIMEGLUMINE 115 mg/5mL Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA] 0006-3915_6145f3e9-40af-4662-896e-5953bff18453 0006-3915 HUMAN PRESCRIPTION DRUG SINEMET carbidopa and levodopa TABLET ORAL 19750502 NDA NDA017555 Merck Sharp & Dohme Corp. CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0006-3916_6145f3e9-40af-4662-896e-5953bff18453 0006-3916 HUMAN PRESCRIPTION DRUG SINEMET carbidopa and levodopa TABLET ORAL 19750502 NDA NDA017555 Merck Sharp & Dohme Corp. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0006-3917_6145f3e9-40af-4662-896e-5953bff18453 0006-3917 HUMAN PRESCRIPTION DRUG SINEMET carbidopa and levodopa TABLET ORAL 19750502 NDA NDA017555 Merck Sharp & Dohme Corp. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0006-3918_6f98927f-48cd-4c54-a67d-f318eac3e5fe 0006-3918 HUMAN PRESCRIPTION DRUG SINEMET CR carbidopa and levodopa TABLET, EXTENDED RELEASE ORAL 19910530 NDA NDA019856 Merck Sharp & Dohme Corp. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0006-3919_6f98927f-48cd-4c54-a67d-f318eac3e5fe 0006-3919 HUMAN PRESCRIPTION DRUG SINEMET CR carbidopa and levodopa TABLET, EXTENDED RELEASE ORAL 19910530 NDA NDA019856 Merck Sharp & Dohme Corp. CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0006-3931_feaedfa1-7511-48a2-a33c-4200c90b57cd 0006-3931 HUMAN PRESCRIPTION DRUG ZIOPTAN TAFLUPROST SOLUTION OPHTHALMIC 20120210 NDA NDA202514 Merck Sharp & Dohme Corp. TAFLUPROST .0045 mg/.3mL Prostaglandin Analog [EPC],Prostaglandin Receptor Agonists [MoA],Increased Prostaglandin Activity [PE],Prostaglandins [Chemical/Ingredient] 0006-3941_380fb104-7b53-49c5-852d-350660f24fb3 0006-3941 HUMAN PRESCRIPTION DRUG EMEND FOSAPREPITANT DIMEGLUMINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080125 NDA NDA022023 Merck Sharp & Dohme Corp. FOSAPREPITANT DIMEGLUMINE 150 mg/5mL Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA] 0006-4045_2b955ce0-6209-4198-8a63-44c682073843 0006-4045 VACCINE GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant INJECTION, SUSPENSION INTRAMUSCULAR 20060608 BLA BLA125126 Merck Sharp & Dohme Corp. HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN 40; 40; 20; 20 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4047_1d1605ec-f16c-45ef-a737-a299f8d50c9d 0006-4047 VACCINE RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent SOLUTION ORAL 20060203 BLA BLA125122 Merck Sharp & Dohme Corp. HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN 2200000; 2800000; 2200000; 2000000; 2300000 [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient] 0006-4084_0a9ed47a-275e-48cf-8595-ac616df9856e 0006-4084 PLASMA DERIVATIVE ANTIVENIN Latrodectus mactans KIT 19470514 BLA BLA101062 Merck Sharp & Dohme Corp. 0006-4093_1644ba2a-c49d-4c92-afe5-3fd922dbc8ae 0006-4093 VACCINE RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR; SUBCUTANEOUS 19860723 BLA BLA101066 Merck Sharp & Dohme Corp. HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 5 ug/.5mL Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4094_1644ba2a-c49d-4c92-afe5-3fd922dbc8ae 0006-4094 VACCINE RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR; SUBCUTANEOUS 19860723 BLA BLA101066 Merck Sharp & Dohme Corp. HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 10 ug/mL Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4095_f749f703-1238-47c3-9cf3-5d1da6d2a985 0006-4095 VACCINE VAQTA hepatitis A vaccine, inactivated INJECTION, SUSPENSION INTRAMUSCULAR 19960329 BLA BLA103606 Merck Sharp & Dohme Corp. HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU]/.5mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4096_f749f703-1238-47c3-9cf3-5d1da6d2a985 0006-4096 VACCINE VAQTA hepatitis A vaccine, inactivated INJECTION, SUSPENSION INTRAMUSCULAR 19960329 BLA BLA103606 Merck Sharp & Dohme Corp. HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 50 [iU]/mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4109_2b955ce0-6209-4198-8a63-44c682073843 0006-4109 VACCINE GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant INJECTION, SUSPENSION INTRAMUSCULAR 20060608 BLA BLA125126 Merck Sharp & Dohme Corp. HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN 40; 40; 20; 20 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4119_82974218-c0c8-4142-80a7-2c80fb5928b9 0006-4119 VACCINE GARDASIL 9 Human Papillomavirus 9-valent Vaccine, Recombinant INJECTION, SUSPENSION INTRAMUSCULAR 20141210 BLA BLA125508 Merck Sharp & Dohme Corp. HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN 40; 60; 40; 20; 20; 20; 20; 20; 30 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4121_82974218-c0c8-4142-80a7-2c80fb5928b9 0006-4121 VACCINE GARDASIL 9 Human Papillomavirus 9-valent Vaccine, Recombinant INJECTION, SUSPENSION INTRAMUSCULAR 20141210 BLA BLA125508 Merck Sharp & Dohme Corp. HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN 40; 60; 40; 20; 20; 20; 20; 20; 30 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4229_06ae4676-8b8d-41c1-9e08-6ee2f21be2f1 0006-4229 STANDARDIZED ALLERGENIC GRASTEK Timothy Grass Pollen Allergen Extract TABLET SUBLINGUAL 20140411 BLA BLA125473 Merck Sharp & Dohme Corp. PHLEUM PRATENSE POLLEN 2800 [BAU]/1 Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0006-4309_3e8145dc-57df-4c0a-a3ec-837050b34f95 0006-4309 VACCINE STERILE DILUENT Sterile Water INJECTION SUBCUTANEOUS 20060525 BLA BLA125123 Merck Sharp & Dohme Corp. 0006-4681_99cd2b05-e5ba-4dcd-bede-efa6acbb6e81 0006-4681 VACCINE M-M-R II measles, mumps, and rubella virus vaccine live INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION SUBCUTANEOUS 19710421 BLA BLA101069 Merck Sharp & Dohme Corp. MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN; MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN; RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN 1000; 12500; 1000 [TCID_50]/.5mL; [TCID_50]/.5mL; [TCID_50]/.5mL Live Attenuated Measles Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Measles Vaccine [Chemical/Ingredient],Live Attenuated Mumps Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Mumps Vaccine [Chemical/Ingredient],Live Attenuated Rubella Virus Vaccine [EPC],Actively Acquired Immunity [PE],Rubella Vaccine [Chemical/Ingredient],Vaccines, Attenuated [Chemical/Ingredient] 0006-4739_164d0c51-eb05-4171-880f-bf7baa9dd136 0006-4739 VACCINE PNEUMOVAX 23 pneumococcal vaccine polyvalent INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 19830707 BLA BLA101094 Merck Sharp & Dohme Corp. STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4826_87a30a1e-083a-4397-aa75-745b7780fa69 0006-4826 VACCINE VARIVAX Varicella Virus Vaccine Live INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION SUBCUTANEOUS 19950317 BLA BLA103552 Merck Sharp & Dohme Corp. VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN 1350 [PFU]/.5mL Live Attenuated Varicella Zoster Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Chickenpox Vaccine [Chemical/Ingredient],Live Attenuated Herpes Zoster Virus Vaccine [EPC],Herpes Zoster Vaccine [Chemical/Ingredient] 0006-4827_87a30a1e-083a-4397-aa75-745b7780fa69 0006-4827 VACCINE VARIVAX Varicella Virus Vaccine Live INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION SUBCUTANEOUS 19950317 BLA BLA103552 Merck Sharp & Dohme Corp. VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN 1350 [PFU]/.5mL Live Attenuated Varicella Zoster Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Chickenpox Vaccine [Chemical/Ingredient],Live Attenuated Herpes Zoster Virus Vaccine [EPC],Herpes Zoster Vaccine [Chemical/Ingredient] 0006-4831_f749f703-1238-47c3-9cf3-5d1da6d2a985 0006-4831 VACCINE VAQTA hepatitis A vaccine, inactivated INJECTION, SUSPENSION INTRAMUSCULAR 19960329 BLA BLA103606 Merck Sharp & Dohme Corp. HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU]/.5mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4837_164d0c51-eb05-4171-880f-bf7baa9dd136 0006-4837 VACCINE PNEUMOVAX 23 pneumococcal vaccine polyvalent INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20140721 BLA BLA101094 Merck Sharp & Dohme Corp. STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4841_f749f703-1238-47c3-9cf3-5d1da6d2a985 0006-4841 VACCINE VAQTA hepatitis A vaccine, inactivated INJECTION, SUSPENSION INTRAMUSCULAR 19960329 BLA BLA103606 Merck Sharp & Dohme Corp. HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 50 [iU]/mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4897_96eff106-f303-4140-b50f-34ebb8ad0fb8 0006-4897 VACCINE PedvaxHIB Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) INJECTION, SUSPENSION INTRAMUSCULAR 19891220 BLA BLA103237 Merck Sharp & Dohme Corp. HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN 7.5 ug/.5mL Inactivated Haemophilus Influenzae B Vaccine [EPC],Actively Acquired Immunity [PE],Haemophilus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4898_3266f73b-fc48-4e3d-b466-c8b54803bef8 0006-4898 VACCINE COMVAX Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 19961002 BLA BLA103623 Merck Sharp & Dohme Corp. HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN; HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 7.5; 5 ug/.5mL; ug/.5mL Inactivated Haemophilus Influenzae B Vaccine [EPC],Actively Acquired Immunity [PE],Haemophilus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4943_164d0c51-eb05-4171-880f-bf7baa9dd136 0006-4943 VACCINE PNEUMOVAX 23 pneumococcal vaccine polyvalent INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 19830707 BLA BLA101094 Merck Sharp & Dohme Corp. STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4963_3e8145dc-57df-4c0a-a3ec-837050b34f95 0006-4963 VACCINE ZOSTAVAX Zoster Vaccine Live INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION SUBCUTANEOUS 20060525 BLA BLA125123 Merck Sharp & Dohme Corp. VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN 19400 [PFU]/.65mL Live Attenuated Varicella Zoster Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Chickenpox Vaccine [Chemical/Ingredient],Live Attenuated Herpes Zoster Virus Vaccine [EPC],Herpes Zoster Vaccine [Chemical/Ingredient] 0006-4981_1644ba2a-c49d-4c92-afe5-3fd922dbc8ae 0006-4981 VACCINE RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR; SUBCUTANEOUS 19860723 BLA BLA101066 Merck Sharp & Dohme Corp. HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 5 ug/.5mL Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4992_1644ba2a-c49d-4c92-afe5-3fd922dbc8ae 0006-4992 VACCINE RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR; SUBCUTANEOUS 19860723 BLA BLA101066 Merck Sharp & Dohme Corp. HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 40 ug/mL Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4995_1644ba2a-c49d-4c92-afe5-3fd922dbc8ae 0006-4995 VACCINE RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR; SUBCUTANEOUS 19860723 BLA BLA101066 Merck Sharp & Dohme Corp. HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 10 ug/mL Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 0006-4999_c793f42e-aeb0-46fe-b372-99f76d688cf4 0006-4999 VACCINE ProQuad Measles, Mumps, Rubella and Varicella Virus Vaccine Live INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION SUBCUTANEOUS 20050906 BLA BLA125108 Merck Sharp & Dohme Corp. MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN; MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN; RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN; VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN 1000; 20000; 1000; 9772 [TCID_50]/.5mL; [TCID_50]/.5mL; [TCID_50]/.5mL; [PFU]/.5mL Live Attenuated Measles Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Measles Vaccine [Chemical/Ingredient],Live Attenuated Mumps Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Mumps Vaccine [Chemical/Ingredient],Live Attenuated Rubella Virus Vaccine [EPC],Actively Acquired Immunity [PE],Rubella Vaccine [Chemical/Ingredient],Vaccines, Attenuated [Chemical/Ingredient],Live Attenuated Varicella Zoster Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Chickenpox Vaccine [Chemical/Ingredient],Live Attenuated Herpes Zoster Virus Vaccine [EPC],Herpes Zoster Vaccine [Chemical/Ingredient] 0006-5420_d3bcee7a-e4b2-47ec-b8c1-b67c5c83a766 0006-5420 STANDARDIZED ALLERGENIC RAGWITEK Short Ragweed Pollen Allergen Extract TABLET SUBLINGUAL 20140417 BLA BLA125478 Merck Sharp & Dohme Corp. AMBROSIA ARTEMISIIFOLIA POLLEN 12 [Amb'a'1'U]/1 Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0006-5424_0a9ed47a-275e-48cf-8595-ac616df9856e 0006-5424 PLASMA DERIVATIVE ANTIVENIN Latrodectus mactans KIT 20140501 BLA BLA101062 Merck Sharp & Dohme Corp. 0006-9117_7a0ed70f-3343-407c-9823-6bd237598c45 0006-9117 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, FILM COATED ORAL 19980220 NDA NDA020829 Merck Sharp & Dohme Corp. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0006-9275_7a0ed70f-3343-407c-9823-6bd237598c45 0006-9275 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 19980220 NDA NDA020830 Merck Sharp & Dohme Corp. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0007-3230_26db3097-342b-48cb-a91d-8f39d64c46ca 0007-3230 HUMAN PRESCRIPTION DRUG ARIXTRA fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20050330 20161031 NDA NDA021345 GlaxoSmithKline LLC FONDAPARINUX SODIUM 2.5 mg/.5mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 0007-3232_26db3097-342b-48cb-a91d-8f39d64c46ca 0007-3232 HUMAN PRESCRIPTION DRUG ARIXTRA fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20041117 20161130 NDA NDA021345 GlaxoSmithKline LLC FONDAPARINUX SODIUM 5 mg/.4mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 0007-3234_26db3097-342b-48cb-a91d-8f39d64c46ca 0007-3234 HUMAN PRESCRIPTION DRUG ARIXTRA fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20041117 20161130 NDA NDA021345 GlaxoSmithKline LLC FONDAPARINUX SODIUM 7.5 mg/.6mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 0007-3236_26db3097-342b-48cb-a91d-8f39d64c46ca 0007-3236 HUMAN PRESCRIPTION DRUG ARIXTRA fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20041117 20160930 NDA NDA021345 GlaxoSmithKline LLC FONDAPARINUX SODIUM 10 mg/.8mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 0007-3370_e387006e-1cc8-4bdc-9e60-8ba56941542f 0007-3370 HUMAN PRESCRIPTION DRUG COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070209 NDA NDA022012 GlaxoSmithKline LLC CARVEDILOL PHOSPHATE 10 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0007-3371_e387006e-1cc8-4bdc-9e60-8ba56941542f 0007-3371 HUMAN PRESCRIPTION DRUG COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070206 NDA NDA022012 GlaxoSmithKline LLC CARVEDILOL PHOSPHATE 20 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0007-3372_e387006e-1cc8-4bdc-9e60-8ba56941542f 0007-3372 HUMAN PRESCRIPTION DRUG COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070214 NDA NDA022012 GlaxoSmithKline LLC CARVEDILOL PHOSPHATE 40 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0007-3373_e387006e-1cc8-4bdc-9e60-8ba56941542f 0007-3373 HUMAN PRESCRIPTION DRUG COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070220 NDA NDA022012 GlaxoSmithKline LLC CARVEDILOL PHOSPHATE 80 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0007-3650_7f36d5b8-7b3a-4190-865f-9fed31b84c9e 0007-3650 HUMAN PRESCRIPTION DRUG DYAZIDE hydrochlorothiazide and triamterene CAPSULE ORAL 19940330 NDA NDA016042 GlaxoSmithKline LLC HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 0007-4139_85ba9af4-cafa-4bec-8e69-03914484e2fb 0007-4139 HUMAN PRESCRIPTION DRUG COREG carvedilol TABLET, FILM COATED ORAL 19970603 NDA NDA020297 GlaxoSmithKline LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0007-4140_85ba9af4-cafa-4bec-8e69-03914484e2fb 0007-4140 HUMAN PRESCRIPTION DRUG COREG carvedilol TABLET, FILM COATED ORAL 19970603 NDA NDA020297 GlaxoSmithKline LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0007-4141_85ba9af4-cafa-4bec-8e69-03914484e2fb 0007-4141 HUMAN PRESCRIPTION DRUG COREG carvedilol TABLET, FILM COATED ORAL 19970603 NDA NDA020297 GlaxoSmithKline LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0007-4142_85ba9af4-cafa-4bec-8e69-03914484e2fb 0007-4142 HUMAN PRESCRIPTION DRUG COREG carvedilol TABLET, FILM COATED ORAL 19970603 NDA NDA020297 GlaxoSmithKline LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0007-4201_436feba7-d2db-4957-9bc4-134917e0f7bd 0007-4201 HUMAN PRESCRIPTION DRUG HYCAMTIN topotecan hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19960607 NDA NDA020671 GlaxoSmithKline LLC TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0007-4205_e7b3abdc-a4c8-491c-bbdc-2b0a329b64a8 0007-4205 HUMAN PRESCRIPTION DRUG HYCAMTIN topotecan hydrochloride CAPSULE ORAL 20080916 NDA NDA020981 GlaxoSmithKline LLC TOPOTECAN HYDROCHLORIDE .25 mg/1 Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0007-4207_e7b3abdc-a4c8-491c-bbdc-2b0a329b64a8 0007-4207 HUMAN PRESCRIPTION DRUG HYCAMTIN topotecan hydrochloride CAPSULE ORAL 20080916 NDA NDA020981 GlaxoSmithKline LLC TOPOTECAN HYDROCHLORIDE 1 mg/1 Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0007-4401_09d0d860-542d-46a3-a3eb-96fc14a8a87a 0007-4401 HUMAN PRESCRIPTION DRUG ARRANON nelarabine INJECTION INTRAVENOUS 20060119 NDA NDA021877 GlaxoSmithKline LLC NELARABINE 5 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0007-4407_4d2ea710-a167-4197-bf9c-41c9e60d6ec6 0007-4407 HUMAN PRESCRIPTION DRUG ARGATROBAN argatroban INJECTION, SOLUTION INTRAVENOUS 20001128 NDA NDA020883 GlaxoSmithKline LLC ARGATROBAN 100 mg/mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] 0007-4640_11098ce0-9c63-435b-b927-ec228de70933 0007-4640 HUMAN PRESCRIPTION DRUG PROMACTA eltrombopag olamine TABLET, FILM COATED ORAL 20081124 NDA NDA022291 GlaxoSmithKline LLC ELTROMBOPAG OLAMINE 25 mg/1 Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoiesis Stimulating Agent [EPC],Thrombopoietin Receptor Agonists [MoA],Thrombopoietin Receptor Interactions [MoA] 0007-4641_11098ce0-9c63-435b-b927-ec228de70933 0007-4641 HUMAN PRESCRIPTION DRUG PROMACTA eltrombopag olamine TABLET, FILM COATED ORAL 20081124 NDA NDA022291 GlaxoSmithKline LLC ELTROMBOPAG OLAMINE 50 mg/1 Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoiesis Stimulating Agent [EPC],Thrombopoietin Receptor Agonists [MoA],Thrombopoietin Receptor Interactions [MoA] 0007-4642_11098ce0-9c63-435b-b927-ec228de70933 0007-4642 HUMAN PRESCRIPTION DRUG PROMACTA eltrombopag olamine TABLET, FILM COATED ORAL 20090105 NDA NDA022291 GlaxoSmithKline LLC ELTROMBOPAG OLAMINE 75 mg/1 Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoiesis Stimulating Agent [EPC],Thrombopoietin Receptor Agonists [MoA],Thrombopoietin Receptor Interactions [MoA] 0007-4643_11098ce0-9c63-435b-b927-ec228de70933 0007-4643 HUMAN PRESCRIPTION DRUG PROMACTA eltrombopag olamine TABLET, FILM COATED ORAL 20120102 NDA NDA022291 GlaxoSmithKline LLC ELTROMBOPAG OLAMINE 12.5 mg/1 Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoiesis Stimulating Agent [EPC],Thrombopoietin Receptor Agonists [MoA],Thrombopoietin Receptor Interactions [MoA] 0007-4646_11098ce0-9c63-435b-b927-ec228de70933 0007-4646 HUMAN PRESCRIPTION DRUG PROMACTA eltrombopag olamine TABLET, FILM COATED ORAL 20140310 NDA NDA022291 GlaxoSmithKline LLC ELTROMBOPAG OLAMINE 100 mg/1 Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoiesis Stimulating Agent [EPC],Thrombopoietin Receptor Agonists [MoA],Thrombopoietin Receptor Interactions [MoA] 0007-4882_a6770559-10ee-485e-baf0-6bed610b3cf5 0007-4882 HUMAN PRESCRIPTION DRUG REQUIP XL ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081120 NDA NDA022008 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0007-4883_a6770559-10ee-485e-baf0-6bed610b3cf5 0007-4883 HUMAN PRESCRIPTION DRUG REQUIP XL ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090803 NDA NDA022008 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0007-4885_a6770559-10ee-485e-baf0-6bed610b3cf5 0007-4885 HUMAN PRESCRIPTION DRUG REQUIP XL ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080630 NDA NDA022008 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0007-4887_a6770559-10ee-485e-baf0-6bed610b3cf5 0007-4887 HUMAN PRESCRIPTION DRUG REQUIP XL ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080630 NDA NDA022008 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0007-4888_a6770559-10ee-485e-baf0-6bed610b3cf5 0007-4888 HUMAN PRESCRIPTION DRUG REQUIP XL ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080630 NDA NDA022008 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0007-4890_2ce65527-2c46-452f-80b2-0a1f67493fe0 0007-4890 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 19971010 NDA NDA020658 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0007-4891_2ce65527-2c46-452f-80b2-0a1f67493fe0 0007-4891 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 19971010 NDA NDA020658 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0007-4892_2ce65527-2c46-452f-80b2-0a1f67493fe0 0007-4892 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 19971001 NDA NDA020658 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0007-4893_2ce65527-2c46-452f-80b2-0a1f67493fe0 0007-4893 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 19971003 NDA NDA020658 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0007-4894_2ce65527-2c46-452f-80b2-0a1f67493fe0 0007-4894 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 19971010 NDA NDA020658 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0007-4895_2ce65527-2c46-452f-80b2-0a1f67493fe0 0007-4895 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 20010619 NDA NDA020658 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0007-4896_2ce65527-2c46-452f-80b2-0a1f67493fe0 0007-4896 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 19990921 NDA NDA020658 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0007-5180_6c1cb7a1-f49c-4179-9ab4-6a844a32b35b 0007-5180 HUMAN PRESCRIPTION DRUG ALTABAX retapamulin OINTMENT TOPICAL 20070502 NDA NDA022055 GlaxoSmithKline LLC RETAPAMULIN 10 mg/g pleuromutilin [Chemical/Ingredient],Pleuromutilin Antibacterial [EPC] 0008-0045_d347a992-be44-4c96-8a13-185a4997d70f 0008-0045 HUMAN PRESCRIPTION DRUG vinorelbine tartrate vinorelbine tartrate INJECTION, SOLUTION INTRAVENOUS 20080213 ANDA ANDA178408 Wyeth Pharmaceuticals Company VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 0008-0407_6d0f94b4-82ca-37c7-edb0-4f0702cf6c8d 0008-0407 HUMAN PRESCRIPTION DRUG ANTIVENIN (MICRURUS FULVIUS) antivenin (micrurus fulvius) INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19670601 BLA BLA101099 Wyeth Pharmaceuticals Company NORTH AMERICAN CORAL SNAKE ANTIVENIN (MICRURUS FULVIUS) (EQUINE) 1 g/10mL 0008-0606_292bbd17-528a-4877-b8b9-3fffc08d3a61 0008-0606 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20080131 NDA NDA020987 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0008-0607_292bbd17-528a-4877-b8b9-3fffc08d3a61 0008-0607 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20080131 NDA NDA020987 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0008-0833_f3c3a7b6-79bf-4730-b3b0-4560d305c972 0008-0833 HUMAN PRESCRIPTION DRUG Effexor XR VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0008-0836_f3c3a7b6-79bf-4730-b3b0-4560d305c972 0008-0836 HUMAN PRESCRIPTION DRUG Effexor XR VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0008-0837_f3c3a7b6-79bf-4730-b3b0-4560d305c972 0008-0837 HUMAN PRESCRIPTION DRUG Effexor XR VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0008-0841_7103b8cf-cd9a-4847-a478-cc82563df836 0008-0841 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20000501 NDA NDA020987 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0008-0843_7103b8cf-cd9a-4847-a478-cc82563df836 0008-0843 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20000501 NDA NDA020987 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0008-0844_7103b8cf-cd9a-4847-a478-cc82563df836 0008-0844 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release PANTOPRAZOLE SODIUM GRANULE, DELAYED RELEASE ORAL 20080229 NDA NDA022020 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0008-0923_c3a7ad67-afad-497f-88c1-934aa26c3ed7 0008-0923 HUMAN PRESCRIPTION DRUG Protonix I.V. PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20010501 NDA NDA020988 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PANTOPRAZOLE SODIUM 40 mg/10mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0008-0941_e34a748c-2385-4c4c-91d5-762411a4a759 0008-0941 HUMAN PRESCRIPTION DRUG Protonix I.V. pantoprazole sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20010501 NDA NDA020988 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PANTOPRAZOLE SODIUM 40 mg/10mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0008-1030_bc16cb70-3946-415c-8477-ab19b50f7156 0008-1030 HUMAN PRESCRIPTION DRUG Rapamune SIROLIMUS SOLUTION ORAL 19990901 NDA NDA021083 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. SIROLIMUS 1 mg/mL Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA] 0008-1040_bc16cb70-3946-415c-8477-ab19b50f7156 0008-1040 HUMAN PRESCRIPTION DRUG Rapamune SIROLIMUS TABLET, SUGAR COATED ORAL 20100301 NDA NDA021110 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. SIROLIMUS .5 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA] 0008-1041_bc16cb70-3946-415c-8477-ab19b50f7156 0008-1041 HUMAN PRESCRIPTION DRUG Rapamune SIROLIMUS TABLET, SUGAR COATED ORAL 20010701 NDA NDA021110 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. SIROLIMUS 1 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA] 0008-1042_bc16cb70-3946-415c-8477-ab19b50f7156 0008-1042 HUMAN PRESCRIPTION DRUG Rapamune SIROLIMUS TABLET, SUGAR COATED ORAL 20010701 NDA NDA021110 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. SIROLIMUS 2 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA] 0008-1123_de4e31f2-7874-4eb7-8ed0-3b78f1adc969 0008-1123 HUMAN PRESCRIPTION DRUG Duavee conjugated estrogens/bazedoxifene TABLET, FILM COATED ORAL 20131003 NDA NDA022247 Wyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc. BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED 20; .45 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 0008-1179_af55b937-261b-43ae-9684-e2b1a9546560 0008-1179 HUMAN PRESCRIPTION DRUG Torisel temsirolimus KIT 20070701 NDA NDA022088 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 0008-1211_1b42d40f-5788-4694-b283-c299c4d75db0 0008-1211 HUMAN PRESCRIPTION DRUG Pristiq Extended-Release desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20080501 NDA NDA021992 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0008-1222_1b42d40f-5788-4694-b283-c299c4d75db0 0008-1222 HUMAN PRESCRIPTION DRUG Pristiq Extended-Release desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20080501 NDA NDA021992 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. DESVENLAFAXINE SUCCINATE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0008-2001_d62b9f5e-9d66-4f24-a653-632d9a731b19 0008-2001 HUMAN PRESCRIPTION DRUG Protonix I.V. PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140317 NDA NDA020988 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PANTOPRAZOLE SODIUM 40 mg/10mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0008-4001_0eb1566b-d18e-4f44-acf3-5671b4846981 0008-4001 HUMAN PRESCRIPTION DRUG Protonix I.V. PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130501 NDA NDA020988 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PANTOPRAZOLE SODIUM 40 mg/10mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0008-4117_3a225a1c-6a29-4f41-927b-e1534108c1fe 0008-4117 HUMAN PRESCRIPTION DRUG Trecator ethionamide TABLET, FILM COATED ORAL 20041108 NDA NDA013026 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ETHIONAMIDE 250 mg/1 Antimycobacterial [EPC] 0008-4188_e2f5bfdd-07f1-4b4a-8684-dfb5ff78300d 0008-4188 HUMAN PRESCRIPTION DRUG Cordarone amiodarone hydrochloride TABLET ORAL 19851201 NDA NDA018972 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0008-4990_69dcffa8-8010-45fe-abe1-9d2e8c49a555 0008-4990 HUMAN PRESCRIPTION DRUG Tygacil TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20050601 NDA NDA021821 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. TIGECYCLINE 50 mg/5mL Tetracycline-class Antibacterial [EPC],Tetracyclines [Chemical/Ingredient] 0009-0003_e08a2f5f-56e7-48f5-bdc2-0bcca62eeba3 0009-0003 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Pharmacia and Upjohn Company METHYLPREDNISOLONE SODIUM SUCCINATE 500 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0005_5c2470f6-721d-465e-be68-c4bf15b63435 0009-0005 HUMAN PRESCRIPTION DRUG Solu-Cortef hydrocortisone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19550427 NDA NDA009866 Pharmacia and Upjohn Company HYDROCORTISONE SODIUM SUCCINATE 1000 mg/8mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0011_5c2470f6-721d-465e-be68-c4bf15b63435 0009-0011 HUMAN PRESCRIPTION DRUG Solu-Cortef hydrocortisone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19550427 NDA NDA009866 Pharmacia and Upjohn Company HYDROCORTISONE SODIUM SUCCINATE 100 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0012_b045ffdb-e790-4c6d-8fe7-29e4eaa08a6b 0009-0012 HUMAN PRESCRIPTION DRUG CORTEF hydrocortisone TABLET ORAL 19521215 NDA NDA008697 Pharmacia and Upjohn Company HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0013_5c2470f6-721d-465e-be68-c4bf15b63435 0009-0013 HUMAN PRESCRIPTION DRUG Solu-Cortef hydrocortisone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19550427 NDA NDA009866 Pharmacia and Upjohn Company HYDROCORTISONE SODIUM SUCCINATE 250 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0016_5c2470f6-721d-465e-be68-c4bf15b63435 0009-0016 HUMAN PRESCRIPTION DRUG Solu-Cortef hydrocortisone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19550427 NDA NDA009866 Pharmacia and Upjohn Company HYDROCORTISONE SODIUM SUCCINATE 500 mg/4mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0017_c65fbac2-a76d-42f6-ae03-c5d9bcff0d83 0009-0017 HUMAN PRESCRIPTION DRUG Halcion triazolam TABLET ORAL 19821115 NDA NDA017892 Pharmacia and Upjohn Company TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0009-0018_e08a2f5f-56e7-48f5-bdc2-0bcca62eeba3 0009-0018 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Pharmacia and Upjohn Company METHYLPREDNISOLONE SODIUM SUCCINATE 1 g/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0020_ce98572b-7987-4dcd-b6c2-a7f99662ef43 0009-0020 HUMAN PRESCRIPTION DRUG Medrol methylprednisolone TABLET ORAL 20130920 NDA NDA011153 Pharmacia and Upjohn Company METHYLPREDNISOLONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0022_ce98572b-7987-4dcd-b6c2-a7f99662ef43 0009-0022 HUMAN PRESCRIPTION DRUG Medrol methylprednisolone TABLET ORAL 19571024 NDA NDA011153 Pharmacia and Upjohn Company METHYLPREDNISOLONE 8 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0024_e566d833-649e-4cd5-b2f7-e3f44fa47606 0009-0024 HUMAN PRESCRIPTION DRUG DIDREX benzphetamine hydrochloride TABLET ORAL 19601026 NDA NDA012427 Pharmacia and Upjohn Company BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 0009-0029_2aba4639-15d3-409a-8854-db3ece551e79 0009-0029 HUMAN PRESCRIPTION DRUG Xanax alprazolam TABLET ORAL 19811016 NDA NDA018276 Pharmacia and Upjohn Company ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0009-0031_b045ffdb-e790-4c6d-8fe7-29e4eaa08a6b 0009-0031 HUMAN PRESCRIPTION DRUG CORTEF hydrocortisone TABLET ORAL 19521215 NDA NDA008697 Pharmacia and Upjohn Company HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0039_a1061e71-dc94-4284-9900-f53e05dddbda 0009-0039 HUMAN PRESCRIPTION DRUG Solu-Medrol methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Pharmacia and Upjohn Company METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0039_e08a2f5f-56e7-48f5-bdc2-0bcca62eeba3 0009-0039 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Pharmacia and Upjohn Company METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0044_b045ffdb-e790-4c6d-8fe7-29e4eaa08a6b 0009-0044 HUMAN PRESCRIPTION DRUG CORTEF hydrocortisone TABLET ORAL 19521215 NDA NDA008697 Pharmacia and Upjohn Company HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0047_a1061e71-dc94-4284-9900-f53e05dddbda 0009-0047 HUMAN PRESCRIPTION DRUG Solu-Medrol methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Pharmacia and Upjohn Company METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0047_e08a2f5f-56e7-48f5-bdc2-0bcca62eeba3 0009-0047 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Pharmacia and Upjohn Company METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0049_ce98572b-7987-4dcd-b6c2-a7f99662ef43 0009-0049 HUMAN PRESCRIPTION DRUG Medrol methylprednisolone TABLET ORAL 19571024 NDA NDA011153 Pharmacia and Upjohn Company METHYLPREDNISOLONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0050_48446e5e-e21e-4865-843d-6e1bbf262a77 0009-0050 HUMAN PRESCRIPTION DRUG Provera medroxyprogesterone acetate TABLET ORAL 19590603 NDA NDA011839 Pharmacia and Upjohn Company MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0009-0055_2aba4639-15d3-409a-8854-db3ece551e79 0009-0055 HUMAN PRESCRIPTION DRUG Xanax alprazolam TABLET ORAL 19811016 NDA NDA018276 Pharmacia and Upjohn Company ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0009-0056_ce98572b-7987-4dcd-b6c2-a7f99662ef43 0009-0056 HUMAN PRESCRIPTION DRUG Medrol methylprednisolone TABLET ORAL 19571024 NDA NDA011153 Pharmacia and Upjohn Company METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0057_1748568e-3be2-4dee-8865-ce3c19164d65 0009-0057 HUMAN PRESCRIPTION DRUG Xanax XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA NDA021434 Pharmacia and Upjohn Company ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0009-0059_1748568e-3be2-4dee-8865-ce3c19164d65 0009-0059 HUMAN PRESCRIPTION DRUG Xanax XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA NDA021434 Pharmacia and Upjohn Company ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0009-0064_48446e5e-e21e-4865-843d-6e1bbf262a77 0009-0064 HUMAN PRESCRIPTION DRUG Provera medroxyprogesterone acetate TABLET ORAL 19590603 NDA NDA011839 Pharmacia and Upjohn Company MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0009-0066_1748568e-3be2-4dee-8865-ce3c19164d65 0009-0066 HUMAN PRESCRIPTION DRUG Xanax XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA NDA021434 Pharmacia and Upjohn Company ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0009-0068_1748568e-3be2-4dee-8865-ce3c19164d65 0009-0068 HUMAN PRESCRIPTION DRUG Xanax XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA NDA021434 Pharmacia and Upjohn Company ALPRAZOLAM 3 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0009-0073_ce98572b-7987-4dcd-b6c2-a7f99662ef43 0009-0073 HUMAN PRESCRIPTION DRUG Medrol methylprednisolone TABLET ORAL 19571024 NDA NDA011153 Pharmacia and Upjohn Company METHYLPREDNISOLONE 16 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0085_d5f31a00-673d-447a-925e-97651b82163a 0009-0085 HUMAN PRESCRIPTION DRUG Depo-Testosterone testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 20140701 ANDA ANDA085635 Pharmacia and Upjohn Company TESTOSTERONE CYPIONATE 100 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0009-0086_d5f31a00-673d-447a-925e-97651b82163a 0009-0086 HUMAN PRESCRIPTION DRUG Depo-Testosterone testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 20140701 ANDA ANDA085635 Pharmacia and Upjohn Company TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0009-0090_2aba4639-15d3-409a-8854-db3ece551e79 0009-0090 HUMAN PRESCRIPTION DRUG Xanax alprazolam TABLET ORAL 19811016 NDA NDA018276 Pharmacia and Upjohn Company ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0009-0094_2aba4639-15d3-409a-8854-db3ece551e79 0009-0094 HUMAN PRESCRIPTION DRUG Xanax alprazolam TABLET ORAL 19811016 NDA NDA018276 Pharmacia and Upjohn Company ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0009-0176_ce98572b-7987-4dcd-b6c2-a7f99662ef43 0009-0176 HUMAN PRESCRIPTION DRUG Medrol methylprednisolone TABLET ORAL 19571024 NDA NDA011153 Pharmacia and Upjohn Company METHYLPREDNISOLONE 32 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0225_80bdd6cf-09b5-4712-af13-8c9993aa4b8b 0009-0225 HUMAN PRESCRIPTION DRUG Cleocin Hydrochloride clindamycin hydrochloride CAPSULE ORAL 19700522 NDA NDA050162 Pharmacia and Upjohn Company CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-0233_8aaf9bf1-1224-41e4-a1f3-baba4a16b072 0009-0233 HUMAN PRESCRIPTION DRUG Bacitracin Bacitracin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 19480729 ANDA ANDA060733 Pharmacia and Upjohn Company BACITRACIN A 5000 [USP'U]/mL 0009-0233_8f2b6d4c-cd9d-4b0a-98f2-9785350c3606 0009-0233 HUMAN PRESCRIPTION DRUG Bacitracin Bacitracin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 19480729 ANDA ANDA060733 Pharmacia and Upjohn Company BACITRACIN A 5000 [USP'U]/mL 0009-0234_20dde80c-fc22-4af4-a054-ed674a0d3707 0009-0234 HUMAN PRESCRIPTION DRUG Bacitracin Bacitracin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 19480729 ANDA ANDA060733 Pharmacia and Upjohn Company BACITRACIN 50000 [iU]/9.8mL Decreased Cell Wall Synthesis & Repair [PE] 0009-0241_5a95d362-4ca9-4a07-a480-b5f23aead04b 0009-0241 HUMAN PRESCRIPTION DRUG Bacitracin Bacitracin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 19480729 ANDA ANDA060733 Pharmacia and Upjohn Company BACITRACIN A 5000 [USP'U]/mL 0009-0260_c09602d2-5038-40c2-aec0-ca554bbcb58f 0009-0260 HUMAN PRESCRIPTION DRUG Colestid Colestipol Hydrochloride GRANULE, FOR SUSPENSION ORAL 19770404 NDA NDA017563 Pharmacia and Upjohn Company COLESTIPOL HYDROCHLORIDE 5 g/5g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 0009-0271_bd40c86d-8531-437d-90f4-5240da9f9640 0009-0271 HUMAN PRESCRIPTION DRUG Depo-Estradiol estradiol cypionate INJECTION INTRAMUSCULAR 19790815 ANDA ANDA085470 Pharmacia and Upjohn Company ESTRADIOL CYPIONATE 5 mg/mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0009-0274_e2554b27-9759-4741-9889-7b5bede73ce2 0009-0274 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company METHYLPREDNISOLONE ACETATE 20 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0280_d5c7d140-4ca4-4f25-ab21-1cb2ef2ab226 0009-0280 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0280_e2554b27-9759-4741-9889-7b5bede73ce2 0009-0280 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0286_48446e5e-e21e-4865-843d-6e1bbf262a77 0009-0286 HUMAN PRESCRIPTION DRUG Provera medroxyprogesterone acetate TABLET ORAL 19590603 NDA NDA011839 Pharmacia and Upjohn Company MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0009-0302_ea41b6fc-3d34-4666-9829-98edbf7a9ffc 0009-0302 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140410 NDA NDA050441 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-0306_d5c7d140-4ca4-4f25-ab21-1cb2ef2ab226 0009-0306 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0306_e2554b27-9759-4741-9889-7b5bede73ce2 0009-0306 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0331_80bdd6cf-09b5-4712-af13-8c9993aa4b8b 0009-0331 HUMAN PRESCRIPTION DRUG Cleocin Hydrochloride clindamycin hydrochloride CAPSULE ORAL 19700522 NDA NDA050162 Pharmacia and Upjohn Company CLINDAMYCIN HYDROCHLORIDE 75 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-0341_c3adf81a-f67f-4c96-ba00-b4b2ae229b7c 0009-0341 HUMAN PRESCRIPTION DRUG Glynase glyburide TABLET ORAL 19920304 NDA NDA020051 Pharmacia and Upjohn Company GLYBURIDE 1.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0009-0347_59c7e601-1c2a-46e8-bf85-7162e69754db 0009-0347 HUMAN PRESCRIPTION DRUG Depo-Testosterone testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 19790725 ANDA ANDA085635 Pharmacia and Upjohn Company TESTOSTERONE CYPIONATE 100 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 0009-0352_c3adf81a-f67f-4c96-ba00-b4b2ae229b7c 0009-0352 HUMAN PRESCRIPTION DRUG Glynase glyburide TABLET ORAL 19920304 NDA NDA020051 Pharmacia and Upjohn Company GLYBURIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0009-0370_c09602d2-5038-40c2-aec0-ca554bbcb58f 0009-0370 HUMAN PRESCRIPTION DRUG Flavored Colestid Colestipol Hydrochloride GRANULE, FOR SUSPENSION ORAL 19770404 NDA NDA017563 Pharmacia and Upjohn Company COLESTIPOL HYDROCHLORIDE 5 g/7.5g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 0009-0395_80bdd6cf-09b5-4712-af13-8c9993aa4b8b 0009-0395 HUMAN PRESCRIPTION DRUG Cleocin Hydrochloride clindamycin hydrochloride CAPSULE ORAL 19700522 NDA NDA050162 Pharmacia and Upjohn Company CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-0417_59c7e601-1c2a-46e8-bf85-7162e69754db 0009-0417 HUMAN PRESCRIPTION DRUG Depo-Testosterone testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 19790725 ANDA ANDA085635 Pharmacia and Upjohn Company TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 0009-0436_77b58b42-5ffb-4e35-ba1b-d0e76193b645 0009-0436 HUMAN PRESCRIPTION DRUG R-Gene Arginine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19760615 NDA NDA016931 Pharmacia and Upjohn Company ARGININE HYDROCHLORIDE 10 g/100mL 0009-0450_6d9c3161-83e1-405e-b758-65ff9c57121c 0009-0450 HUMAN PRESCRIPTION DRUG Colestid Colestipol Hydrochloride TABLET ORAL 19940719 NDA NDA020222 Pharmacia and Upjohn Company COLESTIPOL HYDROCHLORIDE 1 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 0009-0520_0b8017d5-ed43-4fcd-9954-d7ef1e4db955 0009-0520 HUMAN PRESCRIPTION DRUG Depo-Testosterone testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 20140331 ANDA ANDA085635 Pharmacia and Upjohn Company TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 0009-0555_dcc9151e-aabc-4337-897e-55cc15a203c6 0009-0555 HUMAN PRESCRIPTION DRUG Lincocin lincomycin hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL 19641229 NDA NDA050317 Pharmacia and Upjohn Company LINCOMYCIN HYDROCHLORIDE 300 mg/mL 0009-0602_ea41b6fc-3d34-4666-9829-98edbf7a9ffc 0009-0602 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140410 NDA NDA050441 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-0626_b92bbdd1-183c-40b7-82e7-1378837f65fb 0009-0626 HUMAN PRESCRIPTION DRUG Depo-Provera medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19601101 NDA NDA012541 Pharmacia and Upjohn Company MEDROXYPROGESTERONE ACETATE 400 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0009-0698_e08a2f5f-56e7-48f5-bdc2-0bcca62eeba3 0009-0698 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Pharmacia and Upjohn Company METHYLPREDNISOLONE SODIUM SUCCINATE 1 g/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0728_367111ac-fc16-4ac1-a148-12477f0829e9 0009-0728 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19721002 NDA NDA050441 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-0746_0f2c896b-7eb8-4bd6-829a-75b2c01d6bbd 0009-0746 HUMAN PRESCRIPTION DRUG Depo-Provera medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19921029 NDA NDA020246 Pharmacia and Upjohn Company MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0009-0758_e08a2f5f-56e7-48f5-bdc2-0bcca62eeba3 0009-0758 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Pharmacia and Upjohn Company METHYLPREDNISOLONE SODIUM SUCCINATE 500 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0760_d0a08552-1611-4a22-9b26-38c407c90ad6 0009-0760 HUMAN PRESCRIPTION DRUG Cleocin Pediatric clindamycin palmitate hydrochloride GRANULE, FOR SOLUTION ORAL 19860417 ANDA ANDA062644 Pharmacia and Upjohn Company CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-0775_367111ac-fc16-4ac1-a148-12477f0829e9 0009-0775 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19721002 NDA NDA050441 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-0796_e08a2f5f-56e7-48f5-bdc2-0bcca62eeba3 0009-0796 HUMAN PRESCRIPTION DRUG Solu-Medrol methylprednisolone sodium succinate KIT 19590402 NDA NDA011856 Pharmacia and Upjohn Company 0009-0825_5c2470f6-721d-465e-be68-c4bf15b63435 0009-0825 HUMAN PRESCRIPTION DRUG Solu-Cortef hydrocortisone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19550427 NDA NDA009866 Pharmacia and Upjohn Company HYDROCORTISONE SODIUM SUCCINATE 100 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0827_f5c08da9-1a0a-41e5-a144-6b5dd7dc9ef9 0009-0827 HUMAN PRESCRIPTION DRUG Prostin E2 dinoprostone SUPPOSITORY VAGINAL 19780118 NDA NDA017810 Pharmacia and Upjohn Company DINOPROSTONE 20 mg/1 Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 0009-0856_4367d7bb-cb69-43c5-a06f-90b0f62d9162 0009-0856 HUMAN PRESCRIPTION DRUG Hemabate carboprost tromethamine INJECTION, SOLUTION INTRAMUSCULAR 19790109 NDA NDA017989 Pharmacia and Upjohn Company CARBOPROST TROMETHAMINE 250 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 0009-0870_367111ac-fc16-4ac1-a148-12477f0829e9 0009-0870 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19721002 NDA NDA050441 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-0900_fdfda1b3-5224-4e9a-a5dd-52aa9e8833b8 0009-0900 HUMAN PRESCRIPTION DRUG SOLU-CORTEF hydrocortisone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVASCULAR 19800427 20150201 NDA NDA009866 Pharmacia and Upjohn Company HYDROCORTISONE SODIUM SUCCINATE 100 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-0901_ea41b6fc-3d34-4666-9829-98edbf7a9ffc 0009-0901 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140410 NDA NDA050441 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-0902_367111ac-fc16-4ac1-a148-12477f0829e9 0009-0902 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19721002 NDA NDA050441 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-1111_bf88217e-95c4-4aac-ae7a-a078a5cb629f 0009-1111 HUMAN PRESCRIPTION DRUG Camptosar irinotecan hydrochloride INJECTION, SOLUTION INTRAVENOUS 19960614 NDA NDA020571 Pharmacia and Upjohn Company IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0009-3073_29060fdb-f59a-4f1e-bad2-6d0269f82b6f 0009-3073 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-3073_436dfa26-1390-4e21-bbef-361a7b7a21e5 0009-3073 HUMAN PRESCRIPTION DRUG Depo-Medrol METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-3116_547ae0e6-3fe9-4324-a027-baa184f79e11 0009-3116 HUMAN PRESCRIPTION DRUG Cleocin T clindamycin phosphate SOLUTION TOPICAL 19800620 NDA NDA050537 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-3124_367111ac-fc16-4ac1-a148-12477f0829e9 0009-3124 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 19871016 ANDA ANDA062803 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-3169_d014cf03-a6e6-4f8b-8085-42573a437189 0009-3169 HUMAN PRESCRIPTION DRUG PROSTIN VR PEDIATRIC alprostadil INJECTION, SOLUTION INTRAVASCULAR; INTRAVENOUS 19811016 NDA NDA018484 Pharmacia and Upjohn Company ALPROSTADIL 500 ug/mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 0009-3329_547ae0e6-3fe9-4324-a027-baa184f79e11 0009-3329 HUMAN PRESCRIPTION DRUG Cleocin T clindamycin phosphate LOTION TOPICAL 19890531 NDA NDA050600 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-3331_547ae0e6-3fe9-4324-a027-baa184f79e11 0009-3331 HUMAN PRESCRIPTION DRUG Cleocin T clindamycin phosphate GEL TOPICAL 19870107 NDA NDA050615 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-3359_ec612309-558f-4491-ab1a-4ec1118a7ad8 0009-3359 HUMAN PRESCRIPTION DRUG Prepidil dinoprostone GEL VAGINAL 19921209 NDA NDA019617 Pharmacia and Upjohn Company DINOPROSTONE .5 mg/3g Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 0009-3375_367111ac-fc16-4ac1-a148-12477f0829e9 0009-3375 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 19900830 NDA NDA050639 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 12 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-3381_367111ac-fc16-4ac1-a148-12477f0829e9 0009-3381 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 19900830 NDA NDA050639 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 6 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-3382_367111ac-fc16-4ac1-a148-12477f0829e9 0009-3382 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 19900830 NDA NDA050639 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 18 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-3447_367111ac-fc16-4ac1-a148-12477f0829e9 0009-3447 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 19871016 ANDA ANDA062803 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-3448_d8db4e1b-0820-460e-b265-051f8671654a 0009-3448 HUMAN PRESCRIPTION DRUG Cleocin clindamycin phosphate CREAM VAGINAL 19920811 NDA NDA050680 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 20 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-3449_c3adf81a-f67f-4c96-ba00-b4b2ae229b7c 0009-3449 HUMAN PRESCRIPTION DRUG Glynase glyburide TABLET ORAL 19920304 NDA NDA020051 Pharmacia and Upjohn Company GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0009-3470_ea41b6fc-3d34-4666-9829-98edbf7a9ffc 0009-3470 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140926 NDA NDA050639 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 6 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-3475_29060fdb-f59a-4f1e-bad2-6d0269f82b6f 0009-3475 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-3475_436dfa26-1390-4e21-bbef-361a7b7a21e5 0009-3475 HUMAN PRESCRIPTION DRUG Depo-Medrol METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0009-3701_ae20976a-01b8-4721-8e71-2eeadae86a16 0009-3701 HUMAN PRESCRIPTION DRUG Caverject ALPROSTADIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 19950706 NDA NDA020379 Pharmacia and Upjohn Company ALPROSTADIL 20.5 ug/mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 0009-3778_ae20976a-01b8-4721-8e71-2eeadae86a16 0009-3778 HUMAN PRESCRIPTION DRUG Caverject ALPROSTADIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 19950706 NDA NDA020379 Pharmacia and Upjohn Company ALPROSTADIL 10.5 ug/mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 0009-3794_1bbb1f6e-272b-444e-87da-90bf9bb2d2ed 0009-3794 HUMAN PRESCRIPTION DRUG Corvert IBUTILIDE FUMARATE INJECTION, SOLUTION INTRAVENOUS 19951228 NDA NDA020491 Pharmacia and Upjohn Company IBUTILIDE FUMARATE .1 mg/mL Antiarrhythmic [EPC] 0009-3794_95941eee-746e-4a33-bb93-4b778336b233 0009-3794 HUMAN PRESCRIPTION DRUG Corvert ibutilide fumarate INJECTION, SOLUTION INTRAVENOUS 19951228 NDA NDA020491 Pharmacia and Upjohn Company IBUTILIDE FUMARATE .1 mg/mL Antiarrhythmic [EPC] 0009-3794_f7c9eee7-1a20-4b49-bcb7-bf67aaa535a3 0009-3794 HUMAN PRESCRIPTION DRUG Corvert IBUTILIDE FUMARATE INJECTION, SOLUTION INTRAVENOUS 19951228 NDA NDA020491 Pharmacia and Upjohn Company IBUTILIDE FUMARATE .1 mg/mL Antiarrhythmic [EPC] 0009-4541_2fd42b47-4ae7-436b-a2c7-202b6fe3379b 0009-4541 HUMAN PRESCRIPTION DRUG Detrol tolterodine tartrate TABLET, FILM COATED ORAL 19980325 NDA NDA020771 Pharmacia and Upjohn Company TOLTERODINE TARTRATE 1 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0009-4544_2fd42b47-4ae7-436b-a2c7-202b6fe3379b 0009-4544 HUMAN PRESCRIPTION DRUG Detrol tolterodine tartrate TABLET, FILM COATED ORAL 19980325 NDA NDA020771 Pharmacia and Upjohn Company TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0009-4709_2711ea0b-1e97-442c-bc7c-24f492d45f48 0009-4709 HUMAN PRESCRIPTION DRUG Depo-SubQ Provera medroxyprogesterone acetate INJECTION, SUSPENSION SUBCUTANEOUS 20050502 NDA NDA021583 Pharmacia and Upjohn Company MEDROXYPROGESTERONE ACETATE 104 mg/.65mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0009-5012_c318aa27-7018-4aee-be0b-8917d0b05a97 0009-5012 HUMAN PRESCRIPTION DRUG Glyset miglitol TABLET, FILM COATED ORAL 19961218 NDA NDA020682 Pharmacia and Upjohn Company MIGLITOL 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 0009-5013_c318aa27-7018-4aee-be0b-8917d0b05a97 0009-5013 HUMAN PRESCRIPTION DRUG Glyset miglitol TABLET, FILM COATED ORAL 19961218 NDA NDA020682 Pharmacia and Upjohn Company MIGLITOL 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 0009-5014_c318aa27-7018-4aee-be0b-8917d0b05a97 0009-5014 HUMAN PRESCRIPTION DRUG Glyset miglitol TABLET, FILM COATED ORAL 19961218 NDA NDA020682 Pharmacia and Upjohn Company MIGLITOL 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 0009-5091_4f41c98d-f05d-4c33-9e72-3bfcec56c703 0009-5091 HUMAN PRESCRIPTION DRUG Ellence epirubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 19990915 NDA NDA050778 Pharmacia and Upjohn Company EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0009-5093_4f41c98d-f05d-4c33-9e72-3bfcec56c703 0009-5093 HUMAN PRESCRIPTION DRUG Ellence epirubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 19990915 NDA NDA050778 Pharmacia and Upjohn Company EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0009-5131_ae20976a-01b8-4721-8e71-2eeadae86a16 0009-5131 HUMAN PRESCRIPTION DRUG Caverject ALPROSTADIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 19950706 NDA NDA020379 Pharmacia and Upjohn Company ALPROSTADIL 5.4 ug/mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 0009-5135_6a75fc1f-890c-4f7d-8377-e70425290a48 0009-5135 HUMAN PRESCRIPTION DRUG Zyvox linezolid TABLET, FILM COATED ORAL 20000418 NDA NDA021130 Pharmacia and Upjohn Company LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] 0009-5136_6a75fc1f-890c-4f7d-8377-e70425290a48 0009-5136 HUMAN PRESCRIPTION DRUG Zyvox linezolid SUSPENSION ORAL 20000418 NDA NDA021132 Pharmacia and Upjohn Company LINEZOLID 100 mg/5mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] 0009-5137_6a75fc1f-890c-4f7d-8377-e70425290a48 0009-5137 HUMAN PRESCRIPTION DRUG Zyvox linezolid INJECTION, SOLUTION INTRAVENOUS 20000418 NDA NDA021131 Pharmacia and Upjohn Company LINEZOLID 200 mg/100mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] 0009-5139_6a75fc1f-890c-4f7d-8377-e70425290a48 0009-5139 HUMAN PRESCRIPTION DRUG Zyvox linezolid INJECTION, SOLUTION INTRAVENOUS 20000418 NDA NDA021131 Pharmacia and Upjohn Company LINEZOLID 400 mg/200mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] 0009-5140_6a75fc1f-890c-4f7d-8377-e70425290a48 0009-5140 HUMAN PRESCRIPTION DRUG Zyvox linezolid INJECTION, SOLUTION INTRAVENOUS 20000418 NDA NDA021131 Pharmacia and Upjohn Company LINEZOLID 600 mg/300mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] 0009-5176_38445056-314d-4717-9208-0f2a05419711 0009-5176 HUMAN PRESCRIPTION DRUG SOMAVERT pegvisomant KIT 20030525 NDA NDA021106 Pharmacia and Upjohn Company 0009-5178_38445056-314d-4717-9208-0f2a05419711 0009-5178 HUMAN PRESCRIPTION DRUG SOMAVERT pegvisomant KIT 20030525 NDA NDA021106 Pharmacia and Upjohn Company 0009-5180_38445056-314d-4717-9208-0f2a05419711 0009-5180 HUMAN PRESCRIPTION DRUG SOMAVERT pegvisomant KIT 20030525 NDA NDA021106 Pharmacia and Upjohn Company 0009-5181_0c2f1183-ea80-4f44-8f57-92939476da8a 0009-5181 HUMAN PRESCRIPTION DRUG Caverject Impulse Alprostadil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 20020611 NDA NDA021212 Pharmacia and Upjohn Company ALPROSTADIL 10 ug/.5mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 0009-5182_0c2f1183-ea80-4f44-8f57-92939476da8a 0009-5182 HUMAN PRESCRIPTION DRUG Caverject Impulse Alprostadil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 20020611 NDA NDA021212 Pharmacia and Upjohn Company ALPROSTADIL 20 ug/.5mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 0009-5190_aeab16fd-eef9-4aaa-a7cb-6086f01ca422 0009-5190 HUMAN PRESCRIPTION DRUG Detrol LA tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20000222 NDA NDA021228 Pharmacia and Upjohn Company TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0009-5191_aeab16fd-eef9-4aaa-a7cb-6086f01ca422 0009-5191 HUMAN PRESCRIPTION DRUG Detrol LA tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20000222 NDA NDA021228 Pharmacia and Upjohn Company TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0009-5199_38445056-314d-4717-9208-0f2a05419711 0009-5199 HUMAN PRESCRIPTION DRUG SOMAVERT pegvisomant KIT 20140731 NDA NDA021106 Pharmacia and Upjohn Company 0009-5200_38445056-314d-4717-9208-0f2a05419711 0009-5200 HUMAN PRESCRIPTION DRUG SOMAVERT pegvisomant KIT 20140731 NDA NDA021106 Pharmacia and Upjohn Company 0009-5400_ce322acf-793c-48e0-8115-a476e7c27b63 0009-5400 HUMAN PRESCRIPTION DRUG Nicotrol nicotine INHALANT RESPIRATORY (INHALATION) 19970502 NDA NDA020714 Pharmacia and Upjohn Company NICOTINE 4 mg/1 Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient] 0009-5401_d434a84f-9736-45d9-8b49-65b2f031b8ef 0009-5401 HUMAN PRESCRIPTION DRUG Nicotrol nicotine SPRAY, METERED NASAL 19960522 NDA NDA020385 Pharmacia and Upjohn Company NICOTINE 10 mg/mL Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient] 0009-6780_ea41b6fc-3d34-4666-9829-98edbf7a9ffc 0009-6780 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140926 NDA NDA050639 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 12 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-7224_aa7b949b-29dc-4c20-995c-18278668bec1 0009-7224 HUMAN PRESCRIPTION DRUG Atgam EQUINE THYMOCYTE IMMUNE GLOBULIN INJECTION, SOLUTION INTRAVENOUS 19811117 BLA BLA103676 Pharmacia and Upjohn Company EQUINE THYMOCYTE IMMUNE GLOBULIN 50 mg/mL Immunoglobulin G [EPC],Lymphocyte Function Alteration [PE],Increased T Lymphocyte Destruction [PE],Antibody-Surface Protein Interactions [MoA],Immunoglobulins [Chemical/Ingredient] 0009-7376_0f2c896b-7eb8-4bd6-829a-75b2c01d6bbd 0009-7376 HUMAN PRESCRIPTION DRUG Depo-Provera medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19921029 NDA NDA020246 Pharmacia and Upjohn Company MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0009-7529_4968599f-322e-4ed5-9657-ba5adceb1837 0009-7529 HUMAN PRESCRIPTION DRUG Camptosar IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19960614 NDA NDA020571 Pharmacia and Upjohn Company IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0009-7663_55de4eb7-606a-4f33-bd2b-21ead32406ff 0009-7663 HUMAN PRESCRIPTION DRUG Aromasin exemestane TABLET ORAL 19991021 NDA NDA020753 Pharmacia and Upjohn Company EXEMESTANE 25 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 0009-7667_72478fd5-9700-4111-9534-f02d7cc59888 0009-7667 HUMAN PRESCRIPTION DRUG Cleocin clindamycin phosphate SUPPOSITORY VAGINAL 19990813 NDA NDA050767 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 100 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0009-7686_ae20976a-01b8-4721-8e71-2eeadae86a16 0009-7686 HUMAN PRESCRIPTION DRUG Caverject ALPROSTADIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 19950706 NDA NDA020379 Pharmacia and Upjohn Company ALPROSTADIL 41.1 ug/mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 0009-9890_ea41b6fc-3d34-4666-9829-98edbf7a9ffc 0009-9890 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140926 NDA NDA050639 Pharmacia and Upjohn Company CLINDAMYCIN PHOSPHATE 18 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0013-0101_b52b01bd-134a-4d50-a29e-a0e9e9f4cc12 0013-0101 HUMAN PRESCRIPTION DRUG Azulfidine Sulfasalazine TABLET ORAL 19500620 NDA NDA007073 Pharmacia and Upjohn Company SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 0013-0102_143406c0-0c6e-4522-b54d-1362b96a922b 0013-0102 HUMAN PRESCRIPTION DRUG Azulfidine EN-tabs Sulfasalazine TABLET, DELAYED RELEASE ORAL 19500620 NDA NDA007073 Pharmacia and Upjohn Company SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 0013-0132_4fa4f7fb-b11d-4772-a876-562a785d92e3 0013-0132 HUMAN PRESCRIPTION DRUG Emcyt estramustine phosphate sodium CAPSULE ORAL 19920101 NDA NDA018045 Pharmacia and Upjohn Company ESTRAMUSTINE PHOSPHATE SODIUM 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC],Estradiol [Chemical/Ingredient],Nitrogen Mustard Compounds [Chemical/Ingredient] 0013-1114_5212cd75-23f7-4585-a74d-9b48ff9e8f9c 0013-1114 HUMAN PRESCRIPTION DRUG Cyklokapron TRANEXAMIC ACID INJECTION, SOLUTION INTRAVENOUS 19861230 NDA NDA019281 Pharmacia and Upjohn Company TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 0013-2150_553d7e3d-9f24-428e-8c36-b9750b1b405b 0013-2150 HUMAN PRESCRIPTION DRUG Estring estradiol RING VAGINAL 19960426 NDA NDA020472 Pharmacia and Upjohn Company ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0013-2576_d7d12e55-cb11-4958-9231-67c2ee48eded 0013-2576 HUMAN PRESCRIPTION DRUG Idamycin PFS idarubicin hydrochloride SOLUTION INTRAVENOUS 19970217 NDA NDA050734 Pharmacia and Upjohn Company IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0013-2586_d7d12e55-cb11-4958-9231-67c2ee48eded 0013-2586 HUMAN PRESCRIPTION DRUG Idamycin PFS idarubicin hydrochloride SOLUTION INTRAVENOUS 19970217 NDA NDA050734 Pharmacia and Upjohn Company IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0013-2596_d7d12e55-cb11-4958-9231-67c2ee48eded 0013-2596 HUMAN PRESCRIPTION DRUG Idamycin PFS idarubicin hydrochloride SOLUTION INTRAVENOUS 19970217 NDA NDA050734 Pharmacia and Upjohn Company IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0013-2626_80988ec5-334e-4808-9844-d0cc5138f7c1 0013-2626 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company 0013-2646_80988ec5-334e-4808-9844-d0cc5138f7c1 0013-2646 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company 0013-2649_80988ec5-334e-4808-9844-d0cc5138f7c1 0013-2649 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company 0013-2650_80988ec5-334e-4808-9844-d0cc5138f7c1 0013-2650 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company 0013-2651_80988ec5-334e-4808-9844-d0cc5138f7c1 0013-2651 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company 0013-2652_80988ec5-334e-4808-9844-d0cc5138f7c1 0013-2652 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company 0013-2653_80988ec5-334e-4808-9844-d0cc5138f7c1 0013-2653 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company 0013-2654_80988ec5-334e-4808-9844-d0cc5138f7c1 0013-2654 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company 0013-2655_80988ec5-334e-4808-9844-d0cc5138f7c1 0013-2655 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company 0013-2656_80988ec5-334e-4808-9844-d0cc5138f7c1 0013-2656 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company 0013-2657_80988ec5-334e-4808-9844-d0cc5138f7c1 0013-2657 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company 0013-2658_80988ec5-334e-4808-9844-d0cc5138f7c1 0013-2658 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company 0013-5301_b4193269-9831-4bf9-b455-61c8e201435d 0013-5301 HUMAN PRESCRIPTION DRUG Mycobutin rifabutin CAPSULE ORAL 19921223 NDA NDA050689 Pharmacia and Upjohn Company RIFABUTIN 150 mg/1 Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient] 0013-8303_f24694e2-1e03-43e8-b10c-d514bda49dd6 0013-8303 HUMAN PRESCRIPTION DRUG Xalatan latanoprost SOLUTION OPHTHALMIC 19950320 NDA NDA020597 Pharmacia and Upjohn Company LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 0013-8717_891ea90b-a13c-4b30-ad77-c67db3fb9df7 0013-8717 HUMAN PRESCRIPTION DRUG Zinecard dexrazoxane INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19950526 NDA NDA020212 Pharmacia and Upjohn Company DEXRAZOXANE HYDROCHLORIDE 250 mg/25mL Cytoprotective Agent [EPC] 0013-8727_891ea90b-a13c-4b30-ad77-c67db3fb9df7 0013-8727 HUMAN PRESCRIPTION DRUG Zinecard dexrazoxane INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19950526 NDA NDA020212 Pharmacia and Upjohn Company DEXRAZOXANE HYDROCHLORIDE 500 mg/50mL Cytoprotective Agent [EPC] 0015-0508_e4bcfee5-5c3b-4fa5-8ec0-0babd48f5c86 0015-0508 HUMAN PRESCRIPTION DRUG MEGACE MEGESTROL ACETATE SUSPENSION ORAL 20090601 NDA NDA020264 E.R. Squibb & Sons, L.L.C. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0015-1910_7eec50cc-e8cd-4728-b6fd-729651a284ae 0015-1910 HUMAN PRESCRIPTION DRUG IXEMPRA ixabepilone KIT 20071016 NDA NDA022065 E.R. Squibb & Sons, L.L.C. 0015-1911_7eec50cc-e8cd-4728-b6fd-729651a284ae 0015-1911 HUMAN PRESCRIPTION DRUG IXEMPRA ixabepilone KIT 20071016 NDA NDA022065 E.R. Squibb & Sons, L.L.C. 0015-3012_c1780c96-9c2b-4b57-a863-6bbe54216cac 0015-3012 HUMAN PRESCRIPTION DRUG BICNU carmustine KIT 20090601 20150930 NDA NDA017422 E.R. Squibb & Sons, L.L.C. 0015-3030_41126f73-4e7d-4f0f-bdc1-ff89bbba6fb5 0015-3030 HUMAN PRESCRIPTION DRUG CEENU LOMUSTINE CAPSULE, GELATIN COATED ORAL 20081215 20160415 NDA NDA017588 E.R. Squibb & Sons, L.L.C. LOMUSTINE 10 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0015-3031_41126f73-4e7d-4f0f-bdc1-ff89bbba6fb5 0015-3031 HUMAN PRESCRIPTION DRUG CEENU LOMUSTINE CAPSULE, GELATIN COATED ORAL 20081215 20160415 NDA NDA017588 E.R. Squibb & Sons, L.L.C. LOMUSTINE 40 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0015-3075_9498b55f-00bd-41cb-85f0-0220e4817805 0015-3075 HUMAN PRESCRIPTION DRUG VUMON TENIPOSIDE INJECTION, SOLUTION INTRAVENOUS 19920714 20150714 NDA NDA020119 E.R. Squibb & Sons, L.L.C. TENIPOSIDE 10 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0015-3080_1b5c2018-656a-4dce-99c4-315cfc28c43b 0015-3080 HUMAN PRESCRIPTION DRUG LYSODREN MITOTANE TABLET ORAL 20090601 NDA NDA016885 E.R. Squibb & Sons, L.L.C. MITOTANE 500 mg/1 0015-3404_529624cb-22f1-48db-a80b-b751718bdae7 0015-3404 HUMAN PRESCRIPTION DRUG ETOPOPHOS etoposide phosphate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090601 NDA NDA020457 E.R. Squibb & Sons, L.L.C. ETOPOSIDE PHOSPHATE 100 mg/1 Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0019-0862_31aab0d2-6a0b-40e5-a7e8-ac458f22c1f0 0019-0862 HUMAN PRESCRIPTION DRUG Cysto-Conray II Iothalamate meglumine INJECTION URETERAL 20101008 NDA NDA017057 Mallinckrodt Inc. IOTHALAMATE MEGLUMINE 172 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0019-0952_2643b518-8de1-47c9-a24d-8a6f93350c35 0019-0952 HUMAN PRESCRIPTION DRUG Conray 30 Iothalamate Meglumine INJECTION INTRAVASCULAR 20120326 NDA NDA016983 Mallinckrodt Inc. IOTHALAMATE MEGLUMINE 300 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0019-0953_a6fd1249-d86a-49ef-b652-240659258045 0019-0953 HUMAN PRESCRIPTION DRUG Conray iothalamate meglumine INJECTION INTRAVASCULAR 20031014 NDA NDA013295 Mallinckrodt Inc. IOTHALAMATE MEGLUMINE 600 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0019-1177_6a04ff13-9d20-4e77-83a1-56294402ef58 0019-1177 HUMAN PRESCRIPTION DRUG OPTIMARK gadoversetamide INJECTION, SOLUTION INTRAVENOUS 20120122 NDA NDA020937 Mallinckrodt Inc. GADOVERSETAMIDE .5 mmol/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] 0019-1177_93e297a0-73f8-484e-8533-3b87b0452c3e 0019-1177 HUMAN PRESCRIPTION DRUG OPTIMARK GADOVERSETAMIDE INJECTION, SOLUTION INTRAVENOUS 20101210 NDA NDA020975 Mallinckrodt Inc. GADOVERSETAMIDE .5 mmol/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] 0019-1177_c3ffd415-41e9-4e50-9bbe-4d96ef563674 0019-1177 HUMAN PRESCRIPTION DRUG OPTIMARK gadoversetamide INJECTION, SOLUTION INTRAVENOUS 20120122 NDA NDA020976 Mallinckrodt Inc. GADOVERSETAMIDE .5 mmol/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] 0019-1188_d88a144e-853d-4510-8fbe-d4c55cce33ba 0019-1188 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVASCULAR 20120901 NDA NDA021569 Mallinckrodt Inc. SODIUM CHLORIDE .9 mg/mL 0019-1317_2bddf8ba-0aae-4bd2-8be1-ec84dd2e74bc 0019-1317 HUMAN PRESCRIPTION DRUG MD-76R Diatrizoate meglumine and Diatrizoate sodium SOLUTION INTRAVENOUS 19890929 NDA NDA019292 Mallinckrodt Inc. DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM 660; 100 mg/mL; mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0019-1323_7969413f-4ebe-43bc-85de-7869dc890b19 0019-1323 HUMAN PRESCRIPTION DRUG Optiray Pharmacy Bulk Package - 320 Ioversol INJECTION INTRA-ARTERIAL; INTRAVENOUS 20111017 NDA NDA020923 Mallinckrodt Inc. IOVERSOL 678 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0019-1323_f0252133-cdf0-4d91-9dd4-39081e08dcde 0019-1323 HUMAN PRESCRIPTION DRUG Optiray 320 Ioversol INJECTION INTRA-ARTERIAL; INTRAVENOUS 20120304 NDA NDA019710 Mallinckrodt Inc. IOVERSOL 678 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0019-1324_f0252133-cdf0-4d91-9dd4-39081e08dcde 0019-1324 HUMAN PRESCRIPTION DRUG Optiray 240 Ioversol INJECTION INTRA-ARTERIAL; INTRAVENOUS 20120304 NDA NDA019710 Mallinckrodt Inc. IOVERSOL 509 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0019-1332_7969413f-4ebe-43bc-85de-7869dc890b19 0019-1332 HUMAN PRESCRIPTION DRUG Optiray Pharmacy Bulk Package - 300 Ioversol INJECTION INTRA-ARTERIAL; INTRAVENOUS 20111017 NDA NDA020923 Mallinckrodt Inc. IOVERSOL 636 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0019-1332_f0252133-cdf0-4d91-9dd4-39081e08dcde 0019-1332 HUMAN PRESCRIPTION DRUG Optiray 300 Ioversol INJECTION INTRA-ARTERIAL; INTRAVENOUS 20120304 NDA NDA019710 Mallinckrodt Inc. IOVERSOL 636 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0019-1333_7969413f-4ebe-43bc-85de-7869dc890b19 0019-1333 HUMAN PRESCRIPTION DRUG Optiray Pharmacy Bulk Package - 350 Ioversol INJECTION INTRA-ARTERIAL; INTRAVENOUS 20111017 NDA NDA020923 Mallinckrodt Inc. IOVERSOL 741 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0019-1333_f0252133-cdf0-4d91-9dd4-39081e08dcde 0019-1333 HUMAN PRESCRIPTION DRUG Optiray 350 Ioversol INJECTION INTRA-ARTERIAL; INTRAVENOUS 20120304 NDA NDA019710 Mallinckrodt Inc. IOVERSOL 741 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0019-3183_ce8be782-88bf-495d-84f1-e7d0147b5db4 0019-3183 HUMAN PRESCRIPTION DRUG Conray 43 iothalamate meglumine INJECTION INTRAVASCULAR 20101011 NDA NDA013295 Mallinckrodt Inc. IOTHALAMATE MEGLUMINE 430 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0019-4816_15774f9c-0fef-475a-85b9-942de1d961aa 0019-4816 HUMAN PRESCRIPTION DRUG MD-GASTROVIEW diatrizoate meglumine and diatrizoate sodium SOLUTION ORAL; RECTAL 20090831 ANDA ANDA087388 Mallinckrodt Inc. DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM 600; 100 mg/mL; mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0019-5505_a0bf36b3-e4d5-4f67-907f-4110d21dbd83 0019-5505 HUMAN PRESCRIPTION DRUG Hexabrix IOXAGLATE MEGLUMINE and IOXAGLATE SODIUM INJECTION INTRAVASCULAR 19850726 NDA NDA018905 Mallinckrodt Inc. IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM 393; 196 mg/mL; mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0019-9050_335881c4-fcb1-49b4-8335-804aa2705436 0019-9050 HUMAN PRESCRIPTION DRUG OCTREOSCAN Indium In -111 Pentetreotide KIT 20070501 NDA NDA020314 Mallinckrodt Inc. 0019-9068_924787d9-7d80-4bad-adbb-00bb06f13a4b 0019-9068 HUMAN PRESCRIPTION DRUG UltraTag RBC Kit for the preparation of Technetium Tc 99m-Labeled Red Blood Cells KIT 19910610 NDA NDA019981 Mallinckrodt Inc. 0019-9091_02ee4825-1fdd-437b-bc8a-cf22e345095e 0019-9091 HUMAN PRESCRIPTION DRUG TechneScan HDP Technetium Tc 99m Oxidronate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20070227 NDA NDA018321 Mallinckrodt Inc. OXIDRONATE DISODIUM 3.15 mg/1 0019-9092_96931fd5-5e19-486b-b8c5-7fee2c92c893 0019-9092 HUMAN PRESCRIPTION DRUG Kit for the Preparation of Technetium Tc 99m Sestamibi Tc 99m Sestamibi INJECTION INTRAVENOUS 20111031 ANDA ANDA078098 Mallinckrodt Inc. TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1 mg/10mL 0019-9094_40cc2e9f-cb0c-46f4-a516-531d7d3ed019 0019-9094 HUMAN PRESCRIPTION DRUG KIT FOR THE PREPARATION OF TC 99M PYROPHOSPHATE TechneScan PYP INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090320 NDA NDA017538 Mallinckrodt Inc. SODIUM PYROPHOSPHATE; STANNOUS CHLORIDE 11.9; 3.2 mg/10mL; mg/10mL 0019-9096_70b8e0d3-b5ce-427a-ae4f-266ca90b0eef 0019-9096 HUMAN PRESCRIPTION DRUG TechneScan MAG3 Mertiatide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19900615 NDA NDA019882 Mallinckrodt Inc. BETIATIDE 1 mg/1 0019-9120_1c4a4249-890a-44d9-ac04-642fbd45dbdd 0019-9120 HUMAN PRESCRIPTION DRUG THALLOUS CHLORIDE Tl 201 thallous chloride, Tl 201 INJECTION, SOLUTION INTRAVENOUS 20120229 NDA NDA018150 Mallinckrodt Inc. THALLOUS CHLORIDE TL-201 1 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 0019-9132_072b3596-e938-41e4-acea-e45e91a8637e 0019-9132 HUMAN PRESCRIPTION DRUG INDIUM IN 111 CHLORIDE indium in 111 chloride SOLUTION INTRAVENOUS 20071207 NDA NDA019841 Mallinckrodt Inc. INDIUM IN-111 CHLORIDE 10 mCi/mL 0019-9180_df4419b2-3574-4d87-9a50-c5dd16354fb1 0019-9180 HUMAN PRESCRIPTION DRUG GALLIUM CITRATE GA-67 gallium citrate ga-67 INJECTION, SOLUTION INTRAVENOUS 20080221 NDA NDA018058 Mallinckrodt Inc. GALLIUM CHLORIDE GA-67 2 mCi/mL 0019-9450_a07cd378-3b19-4513-8b1f-46349ba21455 0019-9450 HUMAN PRESCRIPTION DRUG Sodium Iodide I-131 Therapeutic sodium iodide, i-131 SOLUTION ORAL 20110822 NDA NDA016515 Mallinckrodt Inc. SODIUM IODIDE I-131 5 mCi/mL Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA] 0019-9451_a07cd378-3b19-4513-8b1f-46349ba21455 0019-9451 HUMAN PRESCRIPTION DRUG Sodium Iodide I-131 Therapeutic sodium iodide, i-131 SOLUTION ORAL 20110822 NDA NDA016515 Mallinckrodt Inc. SODIUM IODIDE I-131 25 mCi/mL Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA] 0019-9452_4d0b6cce-18d2-4aa7-b4e2-93b3550788d9 0019-9452 HUMAN PRESCRIPTION DRUG SODIUM IODIDE I 131 sodium iodide i 131 CAPSULE, GELATIN COATED ORAL 20120125 NDA NDA016517 Mallinckrodt Inc. SODIUM IODIDE I-131 1 mCi/mL Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA] 0019-9601_041daf20-3208-415d-8c52-62f63eb2bfa6 0019-9601 HUMAN PRESCRIPTION DRUG SODIUM IODIDE I 123 sodium iodide i 123 CAPSULE, GELATIN COATED ORAL 20070411 ANDA ANDA071909 Mallinckrodt Inc. SODIUM IODIDE I-123 100 uCi/1 0019-9602_041daf20-3208-415d-8c52-62f63eb2bfa6 0019-9602 HUMAN PRESCRIPTION DRUG SODIUM IODIDE I 123 sodium iodide i 123 CAPSULE, GELATIN COATED ORAL 20070411 ANDA ANDA071910 Mallinckrodt Inc. SODIUM IODIDE I-123 200 uCi/1 0019-9883_94d10086-15c4-42c6-8ff6-8f4ecd9f40ab 0019-9883 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m Generator INJECTION, SOLUTION INTRAVENOUS 19960716 NDA NDA017243 Mallinckrodt Inc. MOLYBDENUM MO-99 1 Ci/1 0019-9884_94d10086-15c4-42c6-8ff6-8f4ecd9f40ab 0019-9884 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m Generator INJECTION, SOLUTION INTRAVENOUS 19960716 NDA NDA017243 Mallinckrodt Inc. MOLYBDENUM MO-99 1.5 Ci/1 0019-9885_94d10086-15c4-42c6-8ff6-8f4ecd9f40ab 0019-9885 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m Generator INJECTION, SOLUTION INTRAVENOUS 19960716 NDA NDA017243 Mallinckrodt Inc. MOLYBDENUM MO-99 2 Ci/1 0019-9886_94d10086-15c4-42c6-8ff6-8f4ecd9f40ab 0019-9886 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m Generator INJECTION, SOLUTION INTRAVENOUS 19960716 NDA NDA017243 Mallinckrodt Inc. MOLYBDENUM MO-99 2.5 Ci/1 0019-9887_94d10086-15c4-42c6-8ff6-8f4ecd9f40ab 0019-9887 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m Generator INJECTION, SOLUTION INTRAVENOUS 19960716 NDA NDA017243 Mallinckrodt Inc. MOLYBDENUM MO-99 3 Ci/1 0019-9888_94d10086-15c4-42c6-8ff6-8f4ecd9f40ab 0019-9888 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m Generator INJECTION, SOLUTION INTRAVENOUS 20050701 NDA NDA017243 Mallinckrodt Inc. MOLYBDENUM MO-99 3.5 Ci/1 0019-9889_94d10086-15c4-42c6-8ff6-8f4ecd9f40ab 0019-9889 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m Generator INJECTION, SOLUTION INTRAVENOUS 20050701 NDA NDA017243 Mallinckrodt Inc. MOLYBDENUM MO-99 5 Ci/1 0019-9890_94d10086-15c4-42c6-8ff6-8f4ecd9f40ab 0019-9890 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m Generator INJECTION, SOLUTION INTRAVENOUS 20050701 NDA NDA017243 Mallinckrodt Inc. MOLYBDENUM MO-99 6 Ci/1 0019-9891_94d10086-15c4-42c6-8ff6-8f4ecd9f40ab 0019-9891 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m Generator INJECTION, SOLUTION INTRAVENOUS 20050701 NDA NDA017243 Mallinckrodt Inc. MOLYBDENUM MO-99 7.5 Ci/1 0019-9892_94d10086-15c4-42c6-8ff6-8f4ecd9f40ab 0019-9892 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m Generator INJECTION, SOLUTION INTRAVENOUS 20050701 NDA NDA017243 Mallinckrodt Inc. MOLYBDENUM MO-99 11 Ci/1 0019-9893_94d10086-15c4-42c6-8ff6-8f4ecd9f40ab 0019-9893 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m Generator INJECTION, SOLUTION INTRAVENOUS 20050701 NDA NDA017243 Mallinckrodt Inc. MOLYBDENUM MO-99 14 Ci/1 0019-9894_94d10086-15c4-42c6-8ff6-8f4ecd9f40ab 0019-9894 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m Generator INJECTION, SOLUTION INTRAVENOUS 20050701 NDA NDA017243 Mallinckrodt Inc. MOLYBDENUM MO-99 16 Ci/1 0019-9895_94d10086-15c4-42c6-8ff6-8f4ecd9f40ab 0019-9895 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m Generator INJECTION, SOLUTION INTRAVENOUS 20050701 NDA NDA017243 Mallinckrodt Inc. MOLYBDENUM MO-99 19 Ci/1 0023-0042_07a5c024-17aa-4198-87a7-8db5d0dfcd54 0023-0042 HUMAN PRESCRIPTION DRUG TAZORAC tazarotene GEL CUTANEOUS 19970801 NDA NDA020600 Allergan, Inc. TAZAROTENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0023-0066_b92c96dd-1869-4fa7-8ac9-7d417e1f3a9e 0023-0066 HUMAN PRESCRIPTION DRUG PRED-G gentamicin sulfate and prednisolone acetate OINTMENT OPHTHALMIC 19900101 NDA NDA050612 Allergan, Inc. GENTAMICIN SULFATE; PREDNISOLONE ACETATE 3; 6 mg/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0023-0106_e6bd006e-c092-43d0-a9a1-f9bc9596a50b 0023-0106 HUMAN PRESCRIPTION DRUG PRED-G gentamicin, prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19900219 NDA NDA050586 Allergan, Inc. GENTAMICIN; PREDNISOLONE ACETATE 3; 10 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0023-0240_748e5be4-4838-4625-b697-0752ffe4f41f 0023-0240 HUMAN OTC DRUG REFRESH P.M. mineral oil, petrolatum OINTMENT OPHTHALMIC 19900423 OTC MONOGRAPH FINAL part349 Allergan, Inc. MINERAL OIL; PETROLATUM 425; 573 mg/g; mg/g 0023-0312_33707096-4210-49e2-953d-23c5c0c1cf48 0023-0312 HUMAN OTC DRUG REFRESH LACRI-LUBE mineral oil, petrolatum OINTMENT OPHTHALMIC 19771215 OTC MONOGRAPH FINAL part349 Allergan, Inc. MINERAL OIL; PETROLATUM 425; 568 mg/g; mg/g 0023-0313_b7b076a9-d41c-438c-8e03-4a0d94605419 0023-0313 HUMAN PRESCRIPTION DRUG BLEPHAMIDE sulfacetamide sodium and prednisolone acetate OINTMENT OPHTHALMIC 19870101 ANDA ANDA087748 Allergan, Inc. PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM 2; 100 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0023-0316_9c77b0ad-2660-4ef1-bd0c-c98c80310633 0023-0316 HUMAN PRESCRIPTION DRUG FML fluorometholone OINTMENT OPHTHALMIC 19851209 NDA NDA017760 Allergan, Inc. FLUOROMETHOLONE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0023-0403_3dcbdeaa-82fd-4ec8-b426-bbef0a5d59c4 0023-0403 HUMAN OTC DRUG REFRESH PLUS carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 19961009 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL 0023-0506_29f3768b-45bc-4ef0-9987-9b3068cf3c86 0023-0506 HUMAN OTC DRUG REFRESH Classic Polyvinyl Alcohol, Povidone SOLUTION/ DROPS OPHTHALMIC 19850912 OTC MONOGRAPH FINAL part349 Allergan, Inc. POLYVINYL ALCOHOL; POVIDONE 14; 6 mg/mL; mg/mL 0023-0798_10553be3-92e1-4051-b5f1-229bb6493d98 0023-0798 HUMAN OTC DRUG REFRESH TEARS carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 19970516 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL 0023-1145_a1d4db54-f02d-491f-be91-15e2f5f2876b 0023-1145 HUMAN PRESCRIPTION DRUG BOTOX onabotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRADERMAL; INTRAMUSCULAR 19891215 BLA BLA103000 Allergan, Inc. BOTULINUM TOXIN TYPE A 100 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] 0023-2181_c3d6f9f9-77f8-4f00-a435-59320ec5e6c8 0023-2181 HUMAN PRESCRIPTION DRUG Acular Ketorolac Tromethamine SOLUTION/ DROPS OPHTHALMIC 19921201 NDA NDA019700 Allergan, Inc. KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0023-3205_0b46a9bd-8f36-4eb8-9dc5-b27efc4665e3 0023-3205 HUMAN PRESCRIPTION DRUG LUMIGAN bimatoprost SOLUTION/ DROPS OPHTHALMIC 20100910 NDA NDA022184 Allergan, Inc. BIMATOPROST .1 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 0023-3240_2358c98f-9740-4da7-ba6d-201984584521 0023-3240 HUMAN OTC DRUG REFRESH OPTIVE carboxymethylcellulose sodium and glycerin SOLUTION/ DROPS OPHTHALMIC 20060906 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL 0023-3348_95e19b00-4334-44d1-9726-487bf786bdff 0023-3348 HUMAN PRESCRIPTION DRUG OZURDEX dexamethasone IMPLANT INTRAVITREAL 20090901 NDA NDA022315 Allergan, Inc. DEXAMETHASONE .7 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0023-3416_18fb4f49-3480-42a9-89ce-b47dcc6f585b 0023-3416 HUMAN OTC DRUG Refresh Optive Carboxymethylcellulose Sodium, Glycerin SOLUTION/ DROPS OPHTHALMIC 20080822 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL 0023-3459_9bf01981-aae8-4c1b-8c6e-e6fa157891bf 0023-3459 HUMAN OTC DRUG VIVITE Daily Facial Moisturizer with Sunscreen SPF 30 octinoxate, octisalate, oxybenzone LOTION TOPICAL 20080519 OTC MONOGRAPH NOT FINAL part352 Allergan, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 60 mg/mL; mg/mL; mg/mL 0023-3507_96918342-3667-470b-86c0-d2640e4a5467 0023-3507 HUMAN PRESCRIPTION DRUG ACUVAIL ketorolac tromethamine SOLUTION/ DROPS OPHTHALMIC 20090801 NDA NDA022427 Allergan, Inc. KETOROLAC TROMETHAMINE 4.5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0023-3513_b5827e15-d555-4f45-bbf5-45648cb9bc2a 0023-3513 HUMAN PRESCRIPTION DRUG SANCTURA trospium chloride TABLET ORAL 20071201 20150919 NDA NDA021595 Allergan, Inc. TROSPIUM CHLORIDE 20 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0023-3615_61a50da5-fd02-4e99-b37f-1680de74967d 0023-3615 HUMAN PRESCRIPTION DRUG ZYMAXID gatifloxacin SOLUTION/ DROPS OPHTHALMIC 20100519 NDA NDA022548 Allergan, Inc. GATIFLOXACIN 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0023-3616_10cf1091-3019-421e-90ba-44d3cc76ae87 0023-3616 HUMAN PRESCRIPTION DRUG LATISSE bimatoprost SOLUTION/ DROPS OPHTHALMIC 20090126 NDA NDA022369 Allergan, Inc. BIMATOPROST .3 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 0023-3670_76d49ab9-6426-4d7e-8f72-fb6f8ad780e2 0023-3670 HUMAN PRESCRIPTION DRUG ACZONE dapsone GEL TOPICAL 20090624 NDA NDA021794 Allergan, Inc. DAPSONE 50 mg/g Sulfone [EPC],Sulfones [Chemical/Ingredient] 0023-3919_b35cb2f6-813a-4693-8a83-2879fe17d510 0023-3919 HUMAN PRESCRIPTION DRUG BOTOX Cosmetic onabotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20080520 BLA BLA103000 Allergan, Inc. BOTULINUM TOXIN TYPE A 50 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] 0023-3921_a1d4db54-f02d-491f-be91-15e2f5f2876b 0023-3921 HUMAN PRESCRIPTION DRUG BOTOX onabotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRADERMAL; INTRAMUSCULAR 20100111 BLA BLA103000 Allergan, Inc. BOTULINUM TOXIN TYPE A 200 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] 0023-4290_e5fae790-23a7-4176-89f7-58cfceeda145 0023-4290 HUMAN PRESCRIPTION DRUG LASTACAFT alcaftadine SOLUTION/ DROPS OPHTHALMIC 20101101 NDA NDA022134 Allergan, Inc. ALCAFTADINE 2.5 mg/mL 0023-4307_f58bb64b-6a8e-4769-9789-df89df449cb2 0023-4307 HUMAN OTC DRUG REFRESH OPTIVE Advanced carboxymethylcellulose sodium, glycerin, and polysorbate 80 SOLUTION/ DROPS OPHTHALMIC 20111130 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN; POLYSORBATE 80 5; 10; 5 mg/mL; mg/mL; mg/mL 0023-4383_a84cc145-308e-4cd3-a622-5e9fe1493b40 0023-4383 HUMAN OTC DRUG VIVITE Aftercare Environmental Protection Sunscreen SPF 30 octinoxate, octisalate, zinc oxide CREAM TOPICAL 20111015 20150630 OTC MONOGRAPH NOT FINAL part352 Allergan, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 40; 78 mg/g; mg/g; mg/g 0023-4385_fcd68e21-f2a9-4de5-bc51-668a7c3c11b9 0023-4385 HUMAN PRESCRIPTION DRUG BETAGAN levobunolol hydrochloride SOLUTION/ DROPS OPHTHALMIC 19860724 NDA NDA019219 Allergan, Inc. LEVOBUNOLOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0023-4491_ecfbf5e7-9b65-43f4-983e-b278a481f13c 0023-4491 HUMAN OTC DRUG REFRESH OPTIVE Advanced carboxymethylcellulose sodium, glycerin, polysorbate 80 SOLUTION/ DROPS OPHTHALMIC 20130115 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN; POLYSORBATE 80 5; 10; 5 mg/mL; mg/mL; mg/mL 0023-4554_e7f9d92e-898b-494b-94fe-7516c0a92a5a 0023-4554 HUMAN OTC DRUG REFRESH CELLUVISC carboxymethylcellulose sodium GEL OPHTHALMIC 19891004 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM 10 mg/mL 0023-4857_0cabbfd5-ec30-44a9-9f64-2532fa0cfe07 0023-4857 HUMAN PRESCRIPTION DRUG VANIQA eflornithine hydrochloride CREAM TOPICAL 20130601 NDA NDA021145 Allergan, Inc. EFLORNITHINE HYDROCHLORIDE 139 mg/g Antiprotozoal [EPC],Decarboxylase Inhibitor [EPC],Decarboxylase Inhibitors [MoA] 0023-4948_b1d568c7-6251-4d63-8bb5-de5a7b450b63 0023-4948 HUMAN OTC DRUG SKIN MEDICA Purifying Foaming Wash salicylic acid LIQUID TOPICAL 20130101 OTC MONOGRAPH FINAL part333D Allergan, Inc. SALICYLIC ACID 20 mg/mL 0023-4951_4a06acb8-2861-4553-a411-53c2c297fd59 0023-4951 HUMAN OTC DRUG SkinMedica Purifying Toner Salicylic Acid LIQUID TOPICAL 20130101 20151031 OTC MONOGRAPH FINAL part333D Allergan, Inc. SALICYLIC ACID 20 mg/mL 0023-4953_76d3e6b9-77a9-40c2-84c9-3bcc173be9b4 0023-4953 HUMAN OTC DRUG SkinMedica TNS Ultimate Daily Moisturizer Sunscreen SPF 20 octinoxate, zinc oxide CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 Allergan, Inc. OCTINOXATE; ZINC OXIDE 75; 53 mg/g; mg/g 0023-4963_0d9101b5-ef9e-421a-8ae8-c614b4cf425d 0023-4963 HUMAN OTC DRUG SkinMedica Daily Physical Defense SPF 30 Sunscreen Titanium Dioxide, zinc oxide CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 Allergan, Inc. TITANIUM DIOXIDE; ZINC OXIDE 73; 34 mg/g; mg/g 0023-4964_2e3b5888-b8e2-4c52-9f53-f777701a603b 0023-4964 HUMAN OTC DRUG SkinMedica Environmental Defense Sunscreen SPF 50 Octinoxate, Octisalate, Octocrylene, Oxybenzone, Zinc Oxide CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 Allergan, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 75; 50; 20; 60; 33 mg/g; mg/g; mg/g; mg/g; mg/g 0023-4965_757fa897-abad-43a3-8f73-facd8bb0f521 0023-4965 HUMAN OTC DRUG SkinMedica Acne Treatment benzoyl peroxide LOTION TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333D Allergan, Inc. BENZOYL PEROXIDE 25 mg/g 0023-7824_d4e588bc-ab78-4f31-9867-a2d6921c58b7 0023-7824 HUMAN PRESCRIPTION DRUG Polytrim polymyxin b sulfate and trimethoprim sulfate SOLUTION/ DROPS OPHTHALMIC 19900123 NDA NDA050567 Allergan, Inc. POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 100000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0023-8335_07a5c024-17aa-4198-87a7-8db5d0dfcd54 0023-8335 HUMAN PRESCRIPTION DRUG TAZORAC tazarotene GEL CUTANEOUS 19970801 NDA NDA020600 Allergan, Inc. TAZAROTENE .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0023-8694_3638e98c-d8f7-4fd5-9e95-c694b5fff976 0023-8694 HUMAN PRESCRIPTION DRUG AZELEX azelaic acid CREAM CUTANEOUS 19960321 NDA NDA020428 Allergan, Inc. AZELAIC ACID .2 g/g Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE] 0023-8842_2f35a2aa-54f1-4abb-b1be-056b17a0d3c5 0023-8842 HUMAN PRESCRIPTION DRUG ALOCRIL nedocromil sodium SOLUTION/ DROPS OPHTHALMIC 20000203 NDA NDA021009 Allergan, Inc. NEDOCROMIL SODIUM 20 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] 0023-9155_f00dc25e-c69b-4685-bdd0-48d8fd634ce3 0023-9155 HUMAN PRESCRIPTION DRUG TAZORAC tazarotene CREAM CUTANEOUS 20001115 NDA NDA021184 Allergan, Inc. TAZAROTENE .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0023-9156_f00dc25e-c69b-4685-bdd0-48d8fd634ce3 0023-9156 HUMAN PRESCRIPTION DRUG TAZORAC tazarotene CREAM CUTANEOUS 20001113 NDA NDA021184 Allergan, Inc. TAZAROTENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0023-9163_f90b48b2-5c9c-4e7b-8b0c-cf23a9486f55 0023-9163 HUMAN PRESCRIPTION DRUG RESTASIS cyclosporine EMULSION OPHTHALMIC 20030401 NDA NDA050790 Allergan, Inc. CYCLOSPORINE .5 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0023-9177_5aef5742-0096-4aee-ab72-1f21d83a3f23 0023-9177 HUMAN PRESCRIPTION DRUG ALPHAGAN P brimonidine tartrate SOLUTION/ DROPS OPHTHALMIC 20010710 NDA NDA021262 Allergan, Inc. BRIMONIDINE TARTRATE 1.5 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0023-9201_e2252a1e-b2f8-40f3-98f5-eacd97fa8683 0023-9201 HUMAN PRESCRIPTION DRUG ELESTAT epinastine hydrochloride SOLUTION/ DROPS OPHTHALMIC 20040119 NDA NDA021565 Allergan, Inc. EPINASTINE HYDROCHLORIDE .5 mg/mL Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 0023-9205_23a03f48-c918-4c61-bd2f-a3803620f781 0023-9205 HUMAN OTC DRUG REFRESH LIQUIGEL Carboxymethylcellulose sodium GEL OPHTHALMIC 20011004 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM 10 mg/mL 0023-9211_f39d9b4d-1cc3-4198-82bf-4bd976bdd360 0023-9211 HUMAN PRESCRIPTION DRUG COMBIGAN brimonidine tartrate, timolol maleate SOLUTION/ DROPS OPHTHALMIC 20071114 NDA NDA021398 Allergan, Inc. BRIMONIDINE TARTRATE; TIMOLOL MALEATE 2; 5 mg/mL; mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0023-9232_b35cb2f6-813a-4693-8a83-2879fe17d510 0023-9232 HUMAN PRESCRIPTION DRUG BOTOX Cosmetic onabotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20020429 BLA BLA103000 Allergan, Inc. BOTULINUM TOXIN TYPE A 100 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] 0023-9236_cd77700e-efb3-455f-897f-b997013a989e 0023-9236 HUMAN PRESCRIPTION DRUG AVAGE tazarotene CREAM CUTANEOUS 20030107 NDA NDA021184 Allergan, Inc. TAZAROTENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0023-9277_429300a4-c16b-4925-b202-ae83efb73d73 0023-9277 HUMAN PRESCRIPTION DRUG ACULAR LS ketorolac tromethamine SOLUTION/ DROPS OPHTHALMIC 20030819 NDA NDA021528 Allergan, Inc. KETOROLAC TROMETHAMINE 4 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0023-9321_5aef5742-0096-4aee-ab72-1f21d83a3f23 0023-9321 HUMAN PRESCRIPTION DRUG ALPHAGAN P brimonidine tartrate SOLUTION/ DROPS OPHTHALMIC 20060125 NDA NDA021770 Allergan, Inc. BRIMONIDINE TARTRATE 1 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0023-9350_c6ed8e13-e1e4-4a85-9c39-836e6cdb7a9c 0023-9350 HUMAN PRESCRIPTION DRUG SANCTURA XR trospium chloride CAPSULE, EXTENDED RELEASE ORAL 20071201 20150304 NDA NDA022103 Allergan, Inc. TROSPIUM CHLORIDE 60 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0024-0222_30ed9b7c-a6e6-4f4e-bfb5-396bae4cc4a0 0024-0222 HUMAN PRESCRIPTION DRUG ELIGARD leuprolide acetate KIT 20020123 NDA NDA021379 sanofi-aventis U.S. LLC 0024-0335_4b1bd4df-00b7-4620-9dc5-bce675a412eb 0024-0335 HUMAN PRESCRIPTION DRUG Demerol Meperidine Hydrochloride TABLET ORAL 19421110 NDA NDA005010 sanofi-aventis U.S. LLC MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0024-0335_e880e6cc-4018-4bea-a722-b8c94a588b34 0024-0335 HUMAN PRESCRIPTION DRUG Demerol Meperidine Hydrochloride TABLET ORAL 20130401 NDA NDA005010 sanofi-aventis U.S. LLC MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0024-0337_4b1bd4df-00b7-4620-9dc5-bce675a412eb 0024-0337 HUMAN PRESCRIPTION DRUG Demerol Meperidine Hydrochloride TABLET ORAL 19421110 NDA NDA005010 sanofi-aventis U.S. LLC MEPERIDINE HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0024-0337_e880e6cc-4018-4bea-a722-b8c94a588b34 0024-0337 HUMAN PRESCRIPTION DRUG Demerol Meperidine Hydrochloride TABLET ORAL 20120521 NDA NDA005010 sanofi-aventis U.S. LLC MEPERIDINE HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0024-0393_e9562081-3217-454f-bb4c-b063baa3e35e 0024-0393 HUMAN PRESCRIPTION DRUG DRISDOL Ergocalciferol CAPSULE, LIQUID FILLED ORAL 19741111 NDA NDA003444 sanofi-aventis U.S. LLC ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 0024-0590_b2765875-6f43-436b-ba0a-acabeaf31461 0024-0590 HUMAN PRESCRIPTION DRUG ELOXATIN oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060602 NDA NDA021759 sanofi-aventis U.S. LLC OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0024-0591_b2765875-6f43-436b-ba0a-acabeaf31461 0024-0591 HUMAN PRESCRIPTION DRUG ELOXATIN oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060602 NDA NDA021759 sanofi-aventis U.S. LLC OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0024-0605_30ed9b7c-a6e6-4f4e-bfb5-396bae4cc4a0 0024-0605 HUMAN PRESCRIPTION DRUG ELIGARD leuprolide acetate KIT 20020123 NDA NDA021731 sanofi-aventis U.S. LLC 0024-0610_30ed9b7c-a6e6-4f4e-bfb5-396bae4cc4a0 0024-0610 HUMAN PRESCRIPTION DRUG ELIGARD leuprolide acetate KIT 20020123 NDA NDA021488 sanofi-aventis U.S. LLC 0024-0793_30ed9b7c-a6e6-4f4e-bfb5-396bae4cc4a0 0024-0793 HUMAN PRESCRIPTION DRUG ELIGARD leuprolide acetate KIT 20020123 NDA NDA021343 sanofi-aventis U.S. LLC 0024-1535_1d226524-68e6-4137-930c-7d2760c7ff39 0024-1535 HUMAN PRESCRIPTION DRUG Phisohex hexachlorophene EMULSION TOPICAL 19760611 NDA NDA006882 sanofi-aventis U.S. LLC HEXACHLOROPHENE 30 mg/mL Antiseptic [EPC] 0024-1562_c91c752e-ad6d-4b17-b1b5-2edc8a86856c 0024-1562 HUMAN PRESCRIPTION DRUG Plaquenil Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 19550418 NDA NDA009768 sanofi-aventis U.S. LLC HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 0024-1596_27e4d62f-6bb1-4fc0-a3a3-3123147a6a4f 0024-1596 HUMAN PRESCRIPTION DRUG Primaquine Phosphate Primaquine Phosphate TABLET, FILM COATED ORAL 20110415 NDA NDA008316 sanofi-aventis U.S. LLC PRIMAQUINE PHOSPHATE 15 mg/1 Antimalarial [EPC] 0024-2791_29b2d12e-c34d-4e6e-bbcb-23b9a1f56e51 0024-2791 HUMAN PRESCRIPTION DRUG Ferrlecit sodium ferric gluconate complex INJECTION INTRAVENOUS 19990218 NDA NDA020955 sanofi-aventis U.S. LLC SODIUM FERRIC GLUCONATE COMPLEX 12.5 mg/mL 0024-2791_915fa27c-c35f-414c-968e-2e87010dd2c1 0024-2791 HUMAN PRESCRIPTION DRUG Ferrlecit sodium ferric gluconate complex INJECTION INTRAVENOUS 19990218 NDA NDA020955 sanofi-aventis U.S. LLC SODIUM FERRIC GLUCONATE COMPLEX 12.5 mg/mL 0024-2792_915fa27c-c35f-414c-968e-2e87010dd2c1 0024-2792 HUMAN PRESCRIPTION DRUG Ferrlecit sodium ferric gluconate complex INJECTION INTRAVENOUS 20110301 NDA NDA020955 sanofi-aventis U.S. LLC SODIUM FERRIC GLUCONATE COMPLEX 12.5 mg/mL 0024-2794_586f2e14-e9ca-4669-ad40-54ec070ec78e 0024-2794 HUMAN PRESCRIPTION DRUG Ferrlecit sodium ferric gluconate complex INJECTION INTRAVENOUS 20140707 NDA NDA020955 sanofi-aventis U.S. LLC SODIUM FERRIC GLUCONATE COMPLEX 12.5 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 0024-4142_29aff701-1cfc-4269-9709-6f3f6e5bcc09 0024-4142 HUMAN PRESCRIPTION DRUG Multaq Dronedarone TABLET, FILM COATED ORAL 20090701 NDA NDA022425 sanofi-aventis U.S. LLC DRONEDARONE 400 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0024-4200_eadeab0a-60dc-4c43-a280-352d1ea0bd73 0024-4200 HUMAN PRESCRIPTION DRUG Uroxatral alfuzosin hydrochloride TABLET, EXTENDED RELEASE ORAL 20090605 NDA NDA021287 sanofi-aventis U.S. LLC ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0024-5150_e4f5664a-70e5-4f00-9150-b569031af3d3 0024-5150 HUMAN PRESCRIPTION DRUG Elitek rasburicase KIT 20020712 BLA BLA103946 sanofi-aventis U.S. LLC 0024-5151_e4f5664a-70e5-4f00-9150-b569031af3d3 0024-5151 HUMAN PRESCRIPTION DRUG Elitek rasburicase KIT 20060601 BLA BLA103940 sanofi-aventis U.S. LLC 0024-5401_679d24ad-d705-4685-94c6-33080910a1ba 0024-5401 HUMAN PRESCRIPTION DRUG Ambien zolpidem tartrate TABLET, FILM COATED ORAL 19930401 NDA NDA019908 sanofi-aventis U.S. LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0024-5421_679d24ad-d705-4685-94c6-33080910a1ba 0024-5421 HUMAN PRESCRIPTION DRUG Ambien zolpidem tartrate TABLET, FILM COATED ORAL 19930401 NDA NDA019908 sanofi-aventis U.S. LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0024-5501_871d10c2-17cd-4e75-994e-b316c2fd3852 0024-5501 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20050919 NDA NDA021774 sanofi-aventis U.S. LLC ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0024-5521_871d10c2-17cd-4e75-994e-b316c2fd3852 0024-5521 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20050919 NDA NDA021774 sanofi-aventis U.S. LLC ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0024-5800_226af22f-7dd3-4c63-a40f-0c1635868d8e 0024-5800 HUMAN PRESCRIPTION DRUG Xyzal levocetirizine dihydrochloride TABLET, FILM COATED ORAL 20070809 NDA NDA022064 Sanofi-Aventis U.S. LLC LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0024-5801_226af22f-7dd3-4c63-a40f-0c1635868d8e 0024-5801 HUMAN PRESCRIPTION DRUG Xyzal levocetirizine dihydrochloride SOLUTION ORAL 20080402 NDA NDA022157 Sanofi-Aventis U.S. LLC LEVOCETIRIZINE DIHYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0024-5810_c25bf565-8061-450a-9217-a7a280ee0424 0024-5810 HUMAN PRESCRIPTION DRUG Aplenzin bupropion hydrobromide TABLET, EXTENDED RELEASE ORAL 20090330 20170331 NDA NDA022108 sanofi-aventis U.S. LLC BUPROPION HYDROBROMIDE 174 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0024-5811_c25bf565-8061-450a-9217-a7a280ee0424 0024-5811 HUMAN PRESCRIPTION DRUG Aplenzin bupropion hydrobromide TABLET, EXTENDED RELEASE ORAL 20090330 20170331 NDA NDA022108 sanofi-aventis U.S. LLC BUPROPION HYDROBROMIDE 348 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0024-5812_c25bf565-8061-450a-9217-a7a280ee0424 0024-5812 HUMAN PRESCRIPTION DRUG Aplenzin bupropion hydrobromide TABLET, EXTENDED RELEASE ORAL 20090330 NDA NDA022108 sanofi-aventis U.S. LLC BUPROPION HYDROBROMIDE 522 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0024-5820_427ec1c3-2a1f-43e0-a2f0-377355265f00 0024-5820 HUMAN PRESCRIPTION DRUG Oforta fludarabine phosphate TABLET, FILM COATED ORAL 20091231 NDA NDA022273 sanofi-aventis U.S. LLC FLUDARABINE PHOSPHATE 10 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0024-5824_91e49aa8-fe67-4c33-8391-0ef4f80d82a5 0024-5824 HUMAN PRESCRIPTION DRUG Jevtana cabazitaxel KIT 20100617 NDA NDA201023 Sanofi-Aventis U.S. LLC 0024-5831_8b98cc58-c32d-4255-b9c9-8ad2ebd7c5ae 0024-5831 HUMAN PRESCRIPTION DRUG Auvi-Q epinephrine INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20121115 NDA NDA201739 sanofi-aventis U.S. LLC EPINEPHRINE .15 mg/1 Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0024-5833_8b98cc58-c32d-4255-b9c9-8ad2ebd7c5ae 0024-5833 HUMAN PRESCRIPTION DRUG Auvi-Q epinephrine INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20121115 NDA NDA201739 sanofi-aventis U.S. LLC EPINEPHRINE .3 mg/1 Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0024-5840_2009f010-9a4b-4b65-932b-cf6e21aa95b5 0024-5840 HUMAN PRESCRIPTION DRUG ZALTRAP ziv-aflibercept SOLUTION, CONCENTRATE INTRAVENOUS 20120803 BLA BLA125418 sanofi-aventis U.S. LLC AFLIBERCEPT 100 mg/4mL 0024-5841_2009f010-9a4b-4b65-932b-cf6e21aa95b5 0024-5841 HUMAN PRESCRIPTION DRUG ZALTRAP ziv-aflibercept SOLUTION, CONCENTRATE INTRAVENOUS 20120803 BLA BLA125418 sanofi-aventis U.S. LLC AFLIBERCEPT 200 mg/8mL 0024-5843_95b04916-3ce2-4785-b102-35b1d3984d59 0024-5843 HUMAN PRESCRIPTION DRUG Leukine SARGRAMOSTIM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 19910501 BLA BLA103362 sanofi-aventis U.S. LLC SARGRAMOSTIM 250 ug/mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] 0024-5844_95b04916-3ce2-4785-b102-35b1d3984d59 0024-5844 HUMAN PRESCRIPTION DRUG Leukine SARGRAMOSTIM LIQUID INTRAVENOUS; SUBCUTANEOUS 19961201 BLA BLA103362 sanofi-aventis U.S. LLC SARGRAMOSTIM 500 ug/mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] 0024-5850_2990431a-da7e-4dbb-a970-4f532c56e8b2 0024-5850 HUMAN PRESCRIPTION DRUG Avapro irbesartan TABLET ORAL 20130101 NDA NDA020757 sanofi-aventis U.S. LLC IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0024-5851_2990431a-da7e-4dbb-a970-4f532c56e8b2 0024-5851 HUMAN PRESCRIPTION DRUG Avapro irbesartan TABLET ORAL 20130101 NDA NDA020757 sanofi-aventis U.S. LLC IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0024-5852_2990431a-da7e-4dbb-a970-4f532c56e8b2 0024-5852 HUMAN PRESCRIPTION DRUG Avapro irbesartan TABLET ORAL 20130101 NDA NDA020757 sanofi-aventis U.S. LLC IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0024-5855_22ca6571-211f-44a5-9b22-c84d27dedf68 0024-5855 HUMAN PRESCRIPTION DRUG Avalide irbesartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130101 NDA NDA020758 sanofi-aventis U.S. LLC HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0024-5856_22ca6571-211f-44a5-9b22-c84d27dedf68 0024-5856 HUMAN PRESCRIPTION DRUG Avalide irbesartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130101 NDA NDA020758 sanofi-aventis U.S. LLC HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0024-5860_43279229-5e81-49e4-8b37-f8f75319ea1b 0024-5860 HUMAN PRESCRIPTION DRUG Clolar clofarabine INJECTION INTRAVENOUS 20130401 NDA NDA021673 sanofi-aventis U.S. LLC CLOFARABINE 1 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0024-5862_6329d865-a7d0-4275-9bd3-06438497d131 0024-5862 HUMAN PRESCRIPTION DRUG Mozobil PLERIXAFOR SOLUTION SUBCUTANEOUS 20130901 NDA NDA022311 sanofi-aventis U.S. LLC PLERIXAFOR 24 mg/1.2mL Hematopoietic Stem Cell Mobilizer [EPC],Increased Hematopoietic Stem Cell Mobilization [PE] 0024-5874_f0956137-4806-4625-bdf4-e356246e6971 0024-5874 HUMAN PRESCRIPTION DRUG Afrezza Insulin Human POWDER, METERED RESPIRATORY (INHALATION) 20140711 NDA NDA022472 Sanofi-Aventis U.S. LLC INSULIN HUMAN 4 1/1 Insulin [Chemical/Ingredient],Insulin [EPC] 0024-5882_f0956137-4806-4625-bdf4-e356246e6971 0024-5882 HUMAN PRESCRIPTION DRUG Afrezza Insulin Human KIT 20140711 NDA NDA022472 Sanofi-Aventis U.S. LLC 0024-5884_f0956137-4806-4625-bdf4-e356246e6971 0024-5884 HUMAN PRESCRIPTION DRUG Afrezza Insulin Human KIT 20140711 NDA NDA022472 Sanofi-Aventis U.S. LLC 0025-0061_185f08c9-15bf-46b1-ada9-89b6782bd868 0025-0061 HUMAN PRESCRIPTION DRUG Lomotil diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19600915 NDA NDA012462 G.D. Searle LLC Division of Pfizer Inc ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 0025-0166_18b4b539-a579-48ba-bc49-fdc416e48464 0025-0166 HUMAN PRESCRIPTION DRUG Synarel nafarelin acetate SPRAY, METERED NASAL 19900213 NDA NDA019886 G.D. Searle LLC Division of Pfizer Inc NAFARELIN ACETATE 2 mg/mL Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] 0025-1001_2271afc6-4f6c-4830-a8f0-090d286831ef 0025-1001 HUMAN PRESCRIPTION DRUG Aldactone spironolactone TABLET, FILM COATED ORAL 19600121 NDA NDA012151 G.D. Searle LLC Division of Pfizer Inc SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0025-1011_50269666-316e-47d1-b276-34ac9c12532e 0025-1011 HUMAN PRESCRIPTION DRUG ALDACTAZIDE spironolactone and hydrochlorothiazide TABLET, FILM COATED ORAL 19780101 NDA NDA012616 G.D. Searle LLC Division of Pfizer Inc HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 25; 25 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0025-1021_50269666-316e-47d1-b276-34ac9c12532e 0025-1021 HUMAN PRESCRIPTION DRUG ALDACTAZIDE spironolactone and hydrochlorothiazide TABLET, FILM COATED ORAL 19780101 NDA NDA012616 G.D. Searle LLC Division of Pfizer Inc HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 50; 50 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0025-1031_2271afc6-4f6c-4830-a8f0-090d286831ef 0025-1031 HUMAN PRESCRIPTION DRUG Aldactone spironolactone TABLET, FILM COATED ORAL 19600121 NDA NDA012151 G.D. Searle LLC Division of Pfizer Inc SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0025-1041_2271afc6-4f6c-4830-a8f0-090d286831ef 0025-1041 HUMAN PRESCRIPTION DRUG Aldactone spironolactone TABLET, FILM COATED ORAL 19600121 NDA NDA012151 G.D. Searle LLC Division of Pfizer Inc SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0025-1381_62795077-f593-470b-b6ad-2b65d57998e4 0025-1381 HUMAN PRESCRIPTION DRUG Daypro OXAPROZIN TABLET, FILM COATED ORAL 19921029 NDA NDA018841 G.D. Searle LLC Division of Pfizer Inc OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0025-1411_84a410a4-8ae5-42a4-993c-b65222f65533 0025-1411 HUMAN PRESCRIPTION DRUG ARTHROTEC diclofenac sodium and misoprostol TABLET, FILM COATED ORAL 19971224 NDA NDA020607 G.D. Searle LLC Division of Pfizer Inc DICLOFENAC SODIUM; MISOPROSTOL 50; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 0025-1421_84a410a4-8ae5-42a4-993c-b65222f65533 0025-1421 HUMAN PRESCRIPTION DRUG ARTHROTEC diclofenac sodium and misoprostol TABLET, FILM COATED ORAL 19971224 NDA NDA020607 G.D. Searle LLC Division of Pfizer Inc DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 0025-1451_6bf000f8-f90f-4bf3-aaeb-6a536baa7af3 0025-1451 HUMAN PRESCRIPTION DRUG Cytotec misoprostol TABLET ORAL 19861227 NDA NDA019268 G.D. Searle LLC Division of Pfizer Inc MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 0025-1461_6bf000f8-f90f-4bf3-aaeb-6a536baa7af3 0025-1461 HUMAN PRESCRIPTION DRUG Cytotec misoprostol TABLET ORAL 19861227 NDA NDA019268 G.D. Searle LLC Division of Pfizer Inc MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 0025-1515_0478a0f7-9267-418e-ab41-e22a200cab28 0025-1515 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 G.D. Searle LLC Division of Pfizer Inc CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0025-1520_0478a0f7-9267-418e-ab41-e22a200cab28 0025-1520 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 G.D. Searle LLC Division of Pfizer Inc CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0025-1525_0478a0f7-9267-418e-ab41-e22a200cab28 0025-1525 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 G.D. Searle LLC Division of Pfizer Inc CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0025-1530_0478a0f7-9267-418e-ab41-e22a200cab28 0025-1530 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 G.D. Searle LLC Division of Pfizer Inc CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0025-1710_6b15df56-c44c-4b44-849a-569166f277a5 0025-1710 HUMAN PRESCRIPTION DRUG Inspra eplerenone TABLET, FILM COATED ORAL 20020927 NDA NDA021437 G.D. Searle LLC Division of Pfizer Inc EPLERENONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0025-1720_6b15df56-c44c-4b44-849a-569166f277a5 0025-1720 HUMAN PRESCRIPTION DRUG Inspra eplerenone TABLET, FILM COATED ORAL 20020927 NDA NDA021437 G.D. Searle LLC Division of Pfizer Inc EPLERENONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0025-1821_44833e43-bd49-48c9-9dc7-e52341c8afef 0025-1821 HUMAN PRESCRIPTION DRUG Flagyl Metronidazole TABLET, FILM COATED ORAL 19630718 NDA NDA012623 G.D. Searle LLC Division of Pfizer Inc METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0025-1831_44833e43-bd49-48c9-9dc7-e52341c8afef 0025-1831 HUMAN PRESCRIPTION DRUG Flagyl Metronidazole TABLET, FILM COATED ORAL 19630718 NDA NDA012623 G.D. Searle LLC Division of Pfizer Inc METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0025-1851_50009bf4-bef1-431d-8e8c-c52b64aa35ba 0025-1851 HUMAN PRESCRIPTION DRUG CALAN verapamil hydrochloride TABLET, FILM COATED ORAL 19840910 NDA NDA018817 G.D. Searle LLC Division of Pfizer Inc VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0025-1861_50009bf4-bef1-431d-8e8c-c52b64aa35ba 0025-1861 HUMAN PRESCRIPTION DRUG CALAN verapamil hydrochloride TABLET, FILM COATED ORAL 19840910 NDA NDA018817 G.D. Searle LLC Division of Pfizer Inc VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0025-1891_59a41064-e261-4491-9ddf-a3fb27033629 0025-1891 HUMAN PRESCRIPTION DRUG CALAN SR verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19861216 NDA NDA019152 G.D. Searle LLC Division of Pfizer Inc VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0025-1901_59a41064-e261-4491-9ddf-a3fb27033629 0025-1901 HUMAN PRESCRIPTION DRUG CALAN SR verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19910306 NDA NDA019152 G.D. Searle LLC Division of Pfizer Inc VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0025-1911_59a41064-e261-4491-9ddf-a3fb27033629 0025-1911 HUMAN PRESCRIPTION DRUG CALAN SR verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19891215 NDA NDA019152 G.D. Searle LLC Division of Pfizer Inc VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0025-1942_49af4d12-8490-4579-8b44-f5acca80bb8a 0025-1942 HUMAN PRESCRIPTION DRUG Flagyl metronidazole CAPSULE ORAL 19950503 NDA NDA020334 G.D. Searle LLC Division of Pfizer Inc METRONIDAZOLE 375 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0025-1961_fc9ef6f6-e77c-4383-b7fd-51e2fb85eafa 0025-1961 HUMAN PRESCRIPTION DRUG Flagyl ER Metronidazole TABLET, FILM COATED, EXTENDED RELEASE ORAL 19971126 NDA NDA020868 G.D. Searle LLC Division of Pfizer Inc METRONIDAZOLE 750 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0025-2011_7adc7e2d-7125-4751-951a-77137249344d 0025-2011 HUMAN PRESCRIPTION DRUG Covera-HS verapamil hydrochloride TABLET, EXTENDED RELEASE ORAL 19960226 NDA NDA020552 G.D. Searle LLC Division of Pfizer Inc VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0025-2021_7adc7e2d-7125-4751-951a-77137249344d 0025-2021 HUMAN PRESCRIPTION DRUG Covera-HS verapamil hydrochloride TABLET, EXTENDED RELEASE ORAL 19960226 NDA NDA020552 G.D. Searle LLC Division of Pfizer Inc VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0025-2732_c4faa477-f97c-41d6-8bd7-6e095ec75067 0025-2732 HUMAN PRESCRIPTION DRUG Norpace disopyramide phosphate CAPSULE, GELATIN COATED ORAL 19820720 NDA NDA018655 G.D. Searle LLC Division of Pfizer Inc DISOPYRAMIDE PHOSPHATE 100 mg/1 Antiarrhythmic [EPC] 0025-2742_c4faa477-f97c-41d6-8bd7-6e095ec75067 0025-2742 HUMAN PRESCRIPTION DRUG Norpace disopyramide phosphate CAPSULE, GELATIN COATED ORAL 19820720 NDA NDA018655 G.D. Searle LLC Division of Pfizer Inc DISOPYRAMIDE PHOSPHATE 150 mg/1 Antiarrhythmic [EPC] 0025-2752_c4faa477-f97c-41d6-8bd7-6e095ec75067 0025-2752 HUMAN PRESCRIPTION DRUG Norpace disopyramide phosphate CAPSULE, GELATIN COATED ORAL 19770901 NDA NDA017447 G.D. Searle LLC Division of Pfizer Inc DISOPYRAMIDE PHOSPHATE 100 mg/1 Antiarrhythmic [EPC] 0025-2762_c4faa477-f97c-41d6-8bd7-6e095ec75067 0025-2762 HUMAN PRESCRIPTION DRUG Norpace disopyramide phosphate CAPSULE, GELATIN COATED ORAL 19770901 NDA NDA017447 G.D. Searle LLC Division of Pfizer Inc DISOPYRAMIDE PHOSPHATE 150 mg/1 Antiarrhythmic [EPC] 0026-3782_519965f9-1cb7-46d2-993b-6662f765850f 0026-3782 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20000626 BLA BLA103332 Bayer HealthCare LLC 0026-3782_828e7fb9-2779-4082-99ae-fef39776c74c 0026-3782 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20130626 BLA BLA103332 Bayer HealthCare LLC 0026-3783_519965f9-1cb7-46d2-993b-6662f765850f 0026-3783 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20000626 BLA BLA103332 Bayer HealthCare LLC 0026-3783_828e7fb9-2779-4082-99ae-fef39776c74c 0026-3783 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20130626 BLA BLA103332 Bayer HealthCare LLC 0026-3785_519965f9-1cb7-46d2-993b-6662f765850f 0026-3785 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20000626 BLA BLA103332 Bayer HealthCare LLC 0026-3785_828e7fb9-2779-4082-99ae-fef39776c74c 0026-3785 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20130626 BLA BLA103332 Bayer HealthCare LLC 0026-3786_519965f9-1cb7-46d2-993b-6662f765850f 0026-3786 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20070607 BLA BLA103332 Bayer HealthCare LLC 0026-3786_828e7fb9-2779-4082-99ae-fef39776c74c 0026-3786 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20130626 BLA BLA103332 Bayer HealthCare LLC 0026-3787_519965f9-1cb7-46d2-993b-6662f765850f 0026-3787 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20090731 BLA BLA103332 Bayer HealthCare LLC 0026-3787_828e7fb9-2779-4082-99ae-fef39776c74c 0026-3787 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20130626 BLA BLA103332 Bayer HealthCare LLC 0026-3792_0c57b877-1bf5-4094-abe9-dcc2dcc1f690 0026-3792 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20051117 BLA BLA103332 Bayer HealthCare LLC 0026-3793_0c57b877-1bf5-4094-abe9-dcc2dcc1f690 0026-3793 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20051117 BLA BLA103332 Bayer HealthCare LLC 0026-3795_0c57b877-1bf5-4094-abe9-dcc2dcc1f690 0026-3795 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20051117 BLA BLA103332 Bayer HealthCare LLC 0026-3796_0c57b877-1bf5-4094-abe9-dcc2dcc1f690 0026-3796 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20080704 BLA BLA103332 Bayer HealthCare LLC 0026-3797_0c57b877-1bf5-4094-abe9-dcc2dcc1f690 0026-3797 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20090731 BLA BLA103332 Bayer HealthCare LLC 0029-1525_bcdde078-52b3-41ef-bc9c-661d129dac0b 0029-1525 HUMAN PRESCRIPTION DRUG BACTROBAN mupirocin OINTMENT TOPICAL 20000407 NDA NDA050591 GlaxoSmithKline LLC MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 0029-1526_92eeca50-44e2-43ef-b8fe-f2773d19aecd 0029-1526 HUMAN PRESCRIPTION DRUG BACTROBAN mupirocin calcium OINTMENT TOPICAL 19960410 NDA NDA050703 GlaxoSmithKline LLC MUPIROCIN CALCIUM 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 0029-1527_723d3ecc-d8e6-477f-8b58-3e5d4bd79a34 0029-1527 HUMAN PRESCRIPTION DRUG BACTROBAN mupirocin calcium CREAM TOPICAL 19980123 NDA NDA050746 GlaxoSmithKline LLC MUPIROCIN CALCIUM 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 0029-6571_6537eaaf-652b-4f59-b00e-e0a2e77489f5 0029-6571 HUMAN PRESCRIPTION DRUG TIMENTIN ticarcillin disodium and clavulanate potassium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19901022 NDA NDA050590 GlaxoSmithKline LLC CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM 1; 30 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0029-6575_6537eaaf-652b-4f59-b00e-e0a2e77489f5 0029-6575 HUMAN PRESCRIPTION DRUG TIMENTIN ticarcillin disodium and clavulanate potassium INJECTION, SOLUTION INTRAVENOUS 19901022 NDA NDA050658 GlaxoSmithKline LLC CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM 1; 30 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0029-6579_6537eaaf-652b-4f59-b00e-e0a2e77489f5 0029-6579 HUMAN PRESCRIPTION DRUG TIMENTIN ticarcillin disodium and clavulanate potassium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19901022 NDA NDA050590 GlaxoSmithKline LLC CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM 1; 30 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0031-2234_4d975f93-20f1-486d-b57d-8555f5e36e46 0031-2234 HUMAN OTC DRUG CHILDRENS DIMETAPP COLD AND COUGH brompheniramine maleate, dextromethorphan HBr, phenylephrine HCl LIQUID ORAL 20060523 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 0031-2235_67764bf0-af50-4689-8f4a-7fc2d8687dc2 0031-2235 HUMAN OTC DRUG CHILDRENS DIMETAPP COLD AND ALLERGY brompheniramine maleate, phenylephrine HCl LIQUID ORAL 20070207 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 0031-2238_059a3e6e-ea98-b0c5-ba27-b7cbbdedc917 0031-2238 HUMAN OTC DRUG CHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD chlorpheniramine maleate, dextromethorphan HBr LIQUID ORAL 20050304 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 1; 7.5 mg/mL; mg/5mL 0031-2246_044a2c5e-15f4-fab3-df78-3a62d1230e74 0031-2246 HUMAN OTC DRUG CHILDRENS DIMETAPP MULTISYMPTOM COLD AND FLU acetaminophen, chlorpheniramine maleate, dextromethorphan HBr, phenylephrine HCl LIQUID ORAL 20101004 OTC MONOGRAPH NOT FINAL part343 Richmond Division of Wyeth ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 0031-2247_04a7f8bc-3d81-569e-7c7d-9c276a497072 0031-2247 HUMAN OTC DRUG CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION diphenhydramine HCl, phenylephrine HCl LIQUID ORAL 20071101 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth LLC, a subsidiary of Pfizer Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 0031-2249_bc20445e-2f92-432e-9677-095369ffe3ee 0031-2249 HUMAN OTC DRUG Childrens Dimetapp Multi-Symptom Cold and Flu acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride LIQUID ORAL 20140701 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 320; 12.5; 5 mg/10mL; mg/10mL; mg/10mL 0031-2293_d3fdc5ee-9822-3eb8-993d-a3cf276cc600 0031-2293 HUMAN OTC DRUG CHILDRENS DIMETAPP COLD AND ALLERGY brompheniramine maleate, phenylephrine HCl TABLET, CHEWABLE ORAL 20050927 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth LLC, a subsidiary of Pfizer Inc. BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/1; mg/1 0031-8649_ab8a877b-879d-4dd2-be2f-d6e14f447022 0031-8649 HUMAN OTC DRUG Robitussin Medi-Soothers Cough DM dextromethorphan hydrobromide and menthol LOZENGE ORAL 20140901 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL, UNSPECIFIED FORM 5; 5 mg/1; mg/1 0031-8692_ee07a83b-7af3-414c-94ba-bb6ab62915d2 0031-8692 HUMAN OTC DRUG Childrens Robitussin Nighttime Cough Long-Acting DM chlorpheniramine maleate, dextromethorphan hyrdrobromide LIQUID ORAL 20140701 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 2; 15 mg/10mL; mg/10mL 0031-8693_becb4025-b63e-f2ea-9d11-d51fdf4e5c13 0031-8693 HUMAN OTC DRUG CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING chlorpheniramine maleate, dextrometrorphan HBr LIQUID ORAL 20040101 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 1; 7.5 mg/5mL; mg/5mL 0031-8694_6170c7d9-2e73-4761-a753-913e85753e20 0031-8694 HUMAN OTC DRUG Childrens Robitussin Cough Long-Acting DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20040101 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg/5mL 0031-8698_e08eea30-66dd-7c00-2527-2cfd83821456 0031-8698 HUMAN OTC DRUG ROBITUSSIN NIGHT TIME COUGH AND COLD diphenhydramine HCl, phenylephrine HCl LIQUID ORAL 20060209 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 0031-8712_eac4dd2a-959b-1214-f17c-70cb896f9f48 0031-8712 HUMAN OTC DRUG ROBITUSSIN TO GO COUGH AND CHEST CONGESTION DM dextromethorphan HBr, guaifenesin LIQUID ORAL 20070731 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 2; 20 mg/mL; mg/mL 0031-8713_55f6e151-92cf-438a-8272-47aaa9b761bc 0031-8713 HUMAN OTC DRUG ROBITUSSIN TO GO COUGH AND COLD CF dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20080107 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 0031-8715_83764afb-8c9b-4506-aa4d-3c1b0d3aa2a9 0031-8715 HUMAN OTC DRUG Childrens Robitussin Cough and Chest Congestion DM dextromethorphan hydrobromide, guaifenesin LIQUID ORAL 20140701 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 0031-8716_543ffdb2-72cb-4d3a-9152-89ea324d8357 0031-8716 HUMAN OTC DRUG Childrens Robitussin Cough and Cold CF DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20090901 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 50; 2.5 mg/5mL; mg/5mL; mg/5mL 0031-8717_7957def3-7e2d-426e-918c-38cf16f47c22 0031-8717 HUMAN OTC DRUG Robitussin Maximum Strength Nighttime Cough DM DEXTROMETHORPHAN HYDROBROMIDE and DOXYLAMINE SUCCINATE LIQUID ORAL 20130301 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/10mL; mg/10mL 0031-8719_9a2d37af-1979-4fd8-9a7c-9b2519782ea1 0031-8719 HUMAN OTC DRUG Robitussin Maximum Strength Cough Plus Chest Congestion DM dextromethorphan hydrobromide and guaifenesin CAPSULE, LIQUID FILLED ORAL 20130523 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/1; mg/1 0031-8721_95223329-9780-4950-ac4d-8de865d31432 0031-8721 HUMAN OTC DRUG ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20120415 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 0031-8722_bd07047f-e2b7-4784-86db-24994b4c12dc 0031-8722 HUMAN OTC DRUG ROBITUSSIN PEAK COLD NIGHTTIME COLD PLUS FLU Acetaminophen, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20120415 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 0031-8724_d83a381c-62f6-4e04-9db0-7528a5c9e6e3 0031-8724 HUMAN OTC DRUG Robitussin Mucus Plus Chest Congestion GUAIFENESIN LIQUID ORAL 20120718 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth GUAIFENESIN 100 mg/5mL 0031-8731_3f5205c9-9029-3555-0993-e19624354ada 0031-8731 HUMAN OTC DRUG ROBITUSSIN PEAK COLD NASAL RELIEF acetaminophen, phenylephrine HCl TABLET ORAL 20110606 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 0031-8732_8140f56b-469c-d437-b26b-d5d9517a8829 0031-8732 HUMAN OTC DRUG ROBITUSSIN PEAK COLD NIGHTTIME NASAL RELIEF acetaminophen, chlorpheniramine maleate, phenylephrine HCl TABLET ORAL 20110606 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 0031-8734_1b7e5948-97dc-a4ae-e545-2c8adb0e4003 0031-8734 HUMAN OTC DRUG ROBITUSSIN PEAK COLD MAXIMUM STRENGTH MULTI-SYMPTOM COLD dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20110615 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL 0031-8735_06753c55-eac0-9317-b80f-714989238eca 0031-8735 HUMAN OTC DRUG ROBITUSSIN PEAK COLD NIGHTTIME MULTI-SYMPTOM COLD acetaminophen, diphenhydramine HCl, phenylephrine HCl LIQUID ORAL 20110615 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 6.25; 2.5 mg/5mL; mg/5mL; mg/5mL 0031-8736_876ca3a0-be3a-42ca-b2ef-a48afd3aaeea 0031-8736 HUMAN OTC DRUG Robitussin Peak Cold Cough Plus Chest Congestion DM dextromethorphan hydrobromide and guaifenesin LIQUID ORAL 20110615 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 0031-8737_876ca3a0-be3a-42ca-b2ef-a48afd3aaeea 0031-8737 HUMAN OTC DRUG Robitussin Peak Cold Sugar-Free Cough Plus Chest Congestion DM dextromethorphan hydrobromide and guaifenesin LIQUID ORAL 20110615 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 0031-8738_e4132f66-f28f-14cb-417b-aabdf12e3364 0031-8738 HUMAN OTC DRUG ROBITUSSIN PEAK COLD MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM dextromethorphan HBr, guaifenesin LIQUID ORAL 20110615 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/5mL; mg/5mL 0031-8740_03f9663b-f98d-b611-4c83-9c3b643e7a31 0031-8740 HUMAN OTC DRUG ROBITUSSIN LINGERING COLD LONG-ACTING COUGH dextromethorphan HBr LIQUID ORAL 20110615 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 0031-8741_e2441138-42ac-4201-8b80-a86c9afd5b8f 0031-8741 HUMAN OTC DRUG ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS dextromethorphan hbr CAPSULE, LIQUID FILLED ORAL 20110606 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 0031-8742_5cc98f97-8f38-43ee-b3ab-c6258384803e 0031-8742 HUMAN OTC DRUG Robitussin Peak Cold Multi-Symptom Cold dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride LIQUID ORAL 20110612 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 0032-1203_3885d979-489b-1335-2fe0-1c848c4bc061 0032-1203 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE ORAL 20100813 NDA NDA020725 AbbVie Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 15000; 3000; 9500 [USP'U]/1; [USP'U]/1; [USP'U]/1 0032-1206_3885d979-489b-1335-2fe0-1c848c4bc061 0032-1206 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE PELLETS ORAL 20100813 NDA NDA020725 AbbVie Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 30000; 6000; 19000 [USP'U]/1; [USP'U]/1; [USP'U]/1 0032-1212_3885d979-489b-1335-2fe0-1c848c4bc061 0032-1212 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE PELLETS ORAL 20100813 NDA NDA020725 AbbVie Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 60000; 12000; 38000 [USP'U]/1; [USP'U]/1; [USP'U]/1 0032-1224_3885d979-489b-1335-2fe0-1c848c4bc061 0032-1224 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE PELLETS ORAL 20100813 NDA NDA020725 AbbVie Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 120000; 24000; 76000 [USP'U]/1; [USP'U]/1; [USP'U]/1 0032-1708_7f8185dd-b6bd-5056-3d49-1350058a5bbb 0032-1708 HUMAN PRESCRIPTION DRUG Prometrium Progesterone CAPSULE ORAL 20100730 NDA NDA019781 AbbVie Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 0032-1711_7f8185dd-b6bd-5056-3d49-1350058a5bbb 0032-1711 HUMAN PRESCRIPTION DRUG Prometrium Progesterone CAPSULE ORAL 20100730 NDA NDA019781 AbbVie Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 0032-3016_3885d979-489b-1335-2fe0-1c848c4bc061 0032-3016 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE PELLETS ORAL 20130104 NDA NDA020725 AbbVie Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 180000; 36000; 114000 [USP'U]/1; [USP'U]/1; [USP'U]/1 0037-0110_5acbd400-e995-11de-bc2c-0002a5d5c51b 0037-0110 HUMAN PRESCRIPTION DRUG Butisol Sodium Butabarbital Sodium SOLUTION ORAL 19780601 ANDA ANDA085380 Meda Pharmaceuticals Inc. BUTABARBITAL SODIUM 30 mg/5mL CIII 0037-0113_5acbd400-e995-11de-bc2c-0002a5d5c51b 0037-0113 HUMAN PRESCRIPTION DRUG Butisol Sodium Butabarbital Sodium TABLET ORAL 19390801 NDA NDA000793 Meda Pharmaceuticals Inc. BUTABARBITAL SODIUM 30 mg/1 CIII 0037-0114_5acbd400-e995-11de-bc2c-0002a5d5c51b 0037-0114 HUMAN PRESCRIPTION DRUG Butisol Sodium Butabarbital Sodium TABLET ORAL 19390801 NDA NDA000793 Meda Pharmaceuticals Inc. BUTABARBITAL SODIUM 50 mg/1 CIII 0037-0241_35e42814-098b-45b3-939a-05fda315c77f 0037-0241 HUMAN PRESCRIPTION DRUG Astelin azelastine hydrochloride SPRAY, METERED NASAL 19961115 20161130 NDA NDA020114 Meda Pharmaceuticals Inc. AZELASTINE HYDROCHLORIDE 137 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0037-0243_4f06675c-8605-428e-88bc-c834a10e7a07 0037-0243 HUMAN PRESCRIPTION DRUG Astepro Azelastine Hydrochloride SPRAY, METERED NASAL 20091012 NDA NDA022371 Meda Pharmaceuticals Inc. AZELASTINE HYDROCHLORIDE 205.5 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0037-0245_39682160-fdf4-11e3-a3ac-0800200c9a66 0037-0245 HUMAN PRESCRIPTION DRUG DYMISTA Azelastine Hydrochloride and Fluticasone Propionate SPRAY, METERED NASAL 20120501 NDA NDA202236 Meda Pharmaceuticals Inc. AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE 137; 50 ug/1; ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0037-0430_1f3aad90-0bde-11e1-be50-0800200c9a66 0037-0430 HUMAN PRESCRIPTION DRUG Felbatol felbamate TABLET ORAL 19930729 NDA NDA020189 Meda Pharmaceuticals Inc. FELBAMATE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0037-0431_1f3aad90-0bde-11e1-be50-0800200c9a66 0037-0431 HUMAN PRESCRIPTION DRUG Felbatol felbamate TABLET ORAL 19930729 NDA NDA020189 Meda Pharmaceuticals Inc. FELBAMATE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0037-0442_1f3aad90-0bde-11e1-be50-0800200c9a66 0037-0442 HUMAN PRESCRIPTION DRUG Felbatol felbamate SUSPENSION ORAL 19930729 NDA NDA020189 Meda Pharmaceuticals Inc. FELBAMATE 600 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0037-0521_ad9da214-d96d-427a-a754-f3a6cf48e274 0037-0521 HUMAN PRESCRIPTION DRUG Lufyllin Dyphylline TABLET ORAL 19760831 ANDA ANDA084566 Meda Pharmaceuticals Inc. DYPHYLLINE 200 mg/1 0037-0731_ad9da214-d96d-427a-a754-f3a6cf48e274 0037-0731 HUMAN PRESCRIPTION DRUG Lufyllin Dyphylline TABLET ORAL 19760831 ANDA ANDA084566 Meda Pharmaceuticals Inc. DYPHYLLINE 400 mg/1 0037-1221_ca3d5380-e0d8-11e1-8960-0002a5d5c51b 0037-1221 HUMAN PRESCRIPTION DRUG Cesamet Nabilone CAPSULE ORAL 20100301 NDA NDA018677 Meda Pharmaceuticals Inc. NABILONE 1 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CII 0037-2001_427ef120-7164-11e2-bcfd-0800200c9a66 0037-2001 HUMAN PRESCRIPTION DRUG Soma Carisoprodol TABLET ORAL 19590701 NDA NDA011792 Meda Pharmaceuticals Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 0037-2250_427ef120-7164-11e2-bcfd-0800200c9a66 0037-2250 HUMAN PRESCRIPTION DRUG Soma Carisoprodol TABLET ORAL 20070901 NDA NDA011792 Meda Pharmaceuticals Inc. CARISOPRODOL 250 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 0037-4401_8afdaf40-dcb8-11e1-baf1-0002a5d5c51b 0037-4401 HUMAN PRESCRIPTION DRUG Depen Penicillamine TABLET ORAL 19781130 NDA NDA019854 Meda Pharmaceuticals Inc. PENICILLAMINE 250 mg/1 Antirheumatic Agent [EPC] 0037-5001_51890c30-f460-11e2-b778-0800200c9a66 0037-5001 HUMAN PRESCRIPTION DRUG Demadex Torsemide TABLET ORAL 20090220 NDA NDA020136 Meda Pharmaceuticals Inc. TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0037-5005_51890c30-f460-11e2-b778-0800200c9a66 0037-5005 HUMAN PRESCRIPTION DRUG Demadex Torsemide TABLET ORAL 20090220 NDA NDA020136 Meda Pharmaceuticals Inc. TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0037-5010_51890c30-f460-11e2-b778-0800200c9a66 0037-5010 HUMAN PRESCRIPTION DRUG Demadex Torsemide TABLET ORAL 20090220 NDA NDA020136 Meda Pharmaceuticals Inc. TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0037-5020_51890c30-f460-11e2-b778-0800200c9a66 0037-5020 HUMAN PRESCRIPTION DRUG Demadex Torsemide TABLET ORAL 20090220 NDA NDA020136 Meda Pharmaceuticals Inc. TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0037-6010_e1c9f570-33d4-11e4-8c21-0800200c9a66 0037-6010 HUMAN PRESCRIPTION DRUG Edluar Zolpidem Tartrate TABLET ORAL 20090724 NDA NDA021997 Meda Pharmaceuticals Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0037-6050_e1c9f570-33d4-11e4-8c21-0800200c9a66 0037-6050 HUMAN PRESCRIPTION DRUG Edluar Zolpidem Tartrate TABLET ORAL 20090724 NDA NDA021997 Meda Pharmaceuticals Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0037-6631_cbcaf7a6-1c21-45b9-bb74-9ca750d2d9c9 0037-6631 HUMAN PRESCRIPTION DRUG AVC sulfanilamide CREAM VAGINAL 20141201 NDA NDA006530 MEDA Pharmaceuticals SULFANILAMIDE 15 g/100g 0037-6820_ad34d2e0-1e98-11e4-8c21-0800200c9a66 0037-6820 HUMAN PRESCRIPTION DRUG COLYTE peg-3350 and electrolytes POWDER, FOR SOLUTION NASOGASTRIC 20140805 NDA NDA018983 MEDA Pharmaceuticals POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE 240; 2.98; 6.72; 5.84; 22.72 g/4L; g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0037-6822_5d50bef0-1d8b-11e4-8c21-0800200c9a66 0037-6822 HUMAN PRESCRIPTION DRUG PROCTOFOAM HC pramoxine hydrochloride hydrocortisone acetate AEROSOL, FOAM TOPICAL 20140815 ANDA ANDA086457 MEDA Pharmaceuticals HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 100; 100 mg/10g; mg/10g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0037-6823_cddc8d80-21b8-11e4-8c21-0800200c9a66 0037-6823 HUMAN OTC DRUG PROCTOFOAM NS pramoxine hydrochloride AEROSOL, FOAM RECTAL 20140818 OTC MONOGRAPH FINAL part346 MEDA PHARMACEUTICALS INC. PRAMOXINE HYDROCHLORIDE 150 mg/15g 0037-6824_b22b8b40-2f1e-11e4-8c21-0800200c9a66 0037-6824 HUMAN PRESCRIPTION DRUG EPIFOAM pramoxine hydrochloride and hydrocortisone acetate AEROSOL, FOAM TOPICAL 20140825 ANDA ANDA086457 MEDA Pharmaceuticals HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 100; 100 mg/10g; mg/10g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0037-6885_08251205-3e27-11e2-a25f-0800200c9a66 0037-6885 HUMAN PRESCRIPTION DRUG BiferaRx Iron Supplement TABLET ORAL 20121031 UNAPPROVED DRUG OTHER Meda Pharmaceuticals Inc. CYANOCOBALAMIN; FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN 25; 1; 6; 22 ug/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 0037-7025_64c2811b-d917-11e2-a28f-0800200c9a66 0037-7025 HUMAN PRESCRIPTION DRUG Optivar Azelastine Hydrochloride SOLUTION/ DROPS INTRAOCULAR 20000522 NDA NDA021127 Meda Pharmaceuticals Inc. AZELASTINE HYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0037-8110_4d8040e0-0063-11e3-b778-0800200c9a66 0037-8110 HUMAN PRESCRIPTION DRUG MUSE Alprostadil SUPPOSITORY URETHRAL 20110722 NDA NDA020700 Meda Pharmaceuticals Inc. ALPROSTADIL 125 ug/1 Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 0037-8120_4d8040e0-0063-11e3-b778-0800200c9a66 0037-8120 HUMAN PRESCRIPTION DRUG MUSE Alprostadil SUPPOSITORY URETHRAL 20110722 NDA NDA020700 Meda Pharmaceuticals Inc. ALPROSTADIL 250 ug/1 Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 0037-8130_4d8040e0-0063-11e3-b778-0800200c9a66 0037-8130 HUMAN PRESCRIPTION DRUG MUSE Alprostadil SUPPOSITORY URETHRAL 20110722 NDA NDA020700 Meda Pharmaceuticals Inc. ALPROSTADIL 500 ug/1 Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 0037-8140_4d8040e0-0063-11e3-b778-0800200c9a66 0037-8140 HUMAN PRESCRIPTION DRUG MUSE Alprostadil SUPPOSITORY URETHRAL 20110722 NDA NDA020700 Meda Pharmaceuticals Inc. ALPROSTADIL 1000 ug/1 Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 0039-0017_d1ea0a9e-f54d-498c-8520-b8e0315a260a 0039-0017 HUMAN PRESCRIPTION DRUG Claforan cefotaxime sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19810311 NDA NDA050547 Sanofi-Aventis U.S. LLC CEFOTAXIME SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0039-0018_d1ea0a9e-f54d-498c-8520-b8e0315a260a 0039-0018 HUMAN PRESCRIPTION DRUG Claforan cefotaxime sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19810311 NDA NDA050547 Sanofi-Aventis U.S. LLC CEFOTAXIME SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0039-0019_d1ea0a9e-f54d-498c-8520-b8e0315a260a 0039-0019 HUMAN PRESCRIPTION DRUG Claforan cefotaxime sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19810311 NDA NDA050547 Sanofi-Aventis U.S. LLC CEFOTAXIME SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0039-0020_d1ea0a9e-f54d-498c-8520-b8e0315a260a 0039-0020 HUMAN PRESCRIPTION DRUG Claforan cefotaxime sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19810311 NDA NDA050547 Sanofi-Aventis U.S. LLC CEFOTAXIME SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0039-0023_d1ea0a9e-f54d-498c-8520-b8e0315a260a 0039-0023 HUMAN PRESCRIPTION DRUG Claforan cefotaxime sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19870113 ANDA ANDA062659 Sanofi-Aventis U.S. LLC CEFOTAXIME SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0039-0024_d1ea0a9e-f54d-498c-8520-b8e0315a260a 0039-0024 HUMAN PRESCRIPTION DRUG Claforan cefotaxime sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19870113 ANDA ANDA062659 Sanofi-Aventis U.S. LLC CEFOTAXIME SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0039-0037_d1ea0a9e-f54d-498c-8520-b8e0315a260a 0039-0037 HUMAN PRESCRIPTION DRUG Claforan cefotaxime sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19850520 NDA NDA050596 Sanofi-Aventis U.S. LLC CEFOTAXIME SODIUM 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0039-0038_d1ea0a9e-f54d-498c-8520-b8e0315a260a 0039-0038 HUMAN PRESCRIPTION DRUG Claforan cefotaxime sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19850520 NDA NDA050596 Sanofi-Aventis U.S. LLC CEFOTAXIME SODIUM 2 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0039-0051_7db9946e-c00c-4e3c-af5c-2b9bffcce746 0039-0051 HUMAN PRESCRIPTION DRUG DiaBeta glyburide TABLET ORAL 20090601 NDA NDA017532 Sanofi-Aventis U.S. LLC GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0039-0052_7db9946e-c00c-4e3c-af5c-2b9bffcce746 0039-0052 HUMAN PRESCRIPTION DRUG DiaBeta glyburide TABLET ORAL 20090601 NDA NDA017532 Sanofi-Aventis U.S. LLC GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0039-0053_7db9946e-c00c-4e3c-af5c-2b9bffcce746 0039-0053 HUMAN PRESCRIPTION DRUG DiaBeta glyburide TABLET ORAL 20090601 NDA NDA017532 Sanofi-Aventis U.S. LLC GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0039-0060_0980536d-7652-41a6-a618-8a708d9ac695 0039-0060 HUMAN PRESCRIPTION DRUG Lasix furosemide TABLET ORAL 19660701 NDA NDA016273 Sanofi-Aventis U.S. LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0039-0066_0980536d-7652-41a6-a618-8a708d9ac695 0039-0066 HUMAN PRESCRIPTION DRUG Lasix furosemide TABLET ORAL 19660701 NDA NDA016273 Sanofi-Aventis U.S. LLC FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0039-0067_0980536d-7652-41a6-a618-8a708d9ac695 0039-0067 HUMAN PRESCRIPTION DRUG Lasix furosemide TABLET ORAL 19660701 NDA NDA016273 Sanofi-Aventis U.S. LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0039-0221_f5d5b7d9-1658-44ef-a7ad-040555ab36f5 0039-0221 HUMAN PRESCRIPTION DRUG AMARYL glimepiride TABLET ORAL 20090618 NDA NDA020496 Sanofi-Aventis U.S. LLC GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0039-0222_f5d5b7d9-1658-44ef-a7ad-040555ab36f5 0039-0222 HUMAN PRESCRIPTION DRUG AMARYL glimepiride TABLET ORAL 20090618 NDA NDA020496 Sanofi-Aventis U.S. LLC GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0039-0223_f5d5b7d9-1658-44ef-a7ad-040555ab36f5 0039-0223 HUMAN PRESCRIPTION DRUG AMARYL glimepiride TABLET ORAL 20090618 NDA NDA020496 Sanofi-Aventis U.S. LLC GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0041-0241_d2619d49-23ad-49d4-b73c-6add34d237f5 0041-0241 HUMAN PRESCRIPTION DRUG Oral-B NeutraCare Mint Neutral Sodium Fluoride GEL DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories SODIUM FLUORIDE 11 mg/g 0041-0340_127fdd22-f93e-49f6-86fe-beaa3a2e413b 0041-0340 HUMAN PRESCRIPTION DRUG Oral-B Minute-Foam Banana Splitz Acidulated Phosphate Fluoride AEROSOL DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories SODIUM FLUORIDE 10 mg/g 0041-0341_c5c2aabe-1929-4388-bfd4-63ea48385792 0041-0341 HUMAN PRESCRIPTION DRUG Oral-B Minute-Foam Mellow Mint Acidulated Phosphate Fluoride AEROSOL DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories SODIUM FLUORIDE 10 mg/g 0041-0342_d02a95f1-c32d-4b91-87f6-45fff1cefea2 0041-0342 HUMAN PRESCRIPTION DRUG Oral-B Minute-Foam Orang-A-Tangy Acidulated Phosphate Fluoride AEROSOL DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories HYDROFLUORIC ACID; SODIUM FLUORIDE 2.3; 10 mg/g; mg/g 0041-0345_cbc81e44-7ce5-4827-b478-44614f591735 0041-0345 HUMAN PRESCRIPTION DRUG Oral-B Minute-Foam Bubble Gum Acidulated Phosphate Fluoride AEROSOL DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories SODIUM FLUORIDE 10 mg/g 0041-0346_e0762a31-0020-4991-8ac6-76f16518a5be 0041-0346 HUMAN PRESCRIPTION DRUG Oral-B Minute-Foam Strawberry Acidulated Phosphate Fluoride AEROSOL DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories SODIUM FLUORIDE 10 mg/g 0041-0347_d4818be4-8820-43b1-86bd-becae2b54e91 0041-0347 HUMAN PRESCRIPTION DRUG Oral-B Minute-Foam Grape Punch Acidulated Phosphate Fluoride AEROSOL DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories SODIUM FLUORIDE 10 mg/g 0041-0348_c2e54b0c-64bc-4a0d-9a23-925f4e039441 0041-0348 HUMAN PRESCRIPTION DRUG Oral-B Neutra-Foam Mint Neutral Sodium Fluoride AEROSOL DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories SODIUM FLUORIDE 9 mg/g 0041-0350_528a2579-cba0-42c0-9202-f79ab840298b 0041-0350 HUMAN PRESCRIPTION DRUG Oral-B Fluorinse Mint Oral-B Fluorinse Mint MOUTHWASH DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories SODIUM FLUORIDE 2 mg/mL 0041-1420_fdb37c8d-9768-4e34-a17a-27124a0895ca 0041-1420 HUMAN OTC DRUG Oral-B Anti-Bacterial Cetylpyridinium Chloride LIQUID DENTAL 20051015 OTC MONOGRAPH NOT FINAL part356 Oral-B Laboratories CETYLPYRIDINIUM CHLORIDE 500 ug/mL 0041-1421_64705480-a0f6-4765-8dc4-7ae64816d3a4 0041-1421 HUMAN OTC DRUG Oral-B Anticavity Sodium Fluoride LIQUID DENTAL 20051015 OTC MONOGRAPH NOT FINAL part355 Oral-B Laboratories SODIUM FLUORIDE 500 ug/mL 0043-0460_f05ad117-0438-4010-a4f8-0640bd7694b3 0043-0460 HUMAN OTC DRUG Theraflu Warming Relief Nighttime Severe Cold And Cough Acetaminophen, Diphenhydramine HCl, Phenylepherine HCl SYRUP ORAL 20070504 OTC MONOGRAPH FINAL part341 Novartis Consumer Health ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL 0043-0461_76c6bf6c-407a-4195-94b2-62ffe4a940e1 0043-0461 HUMAN OTC DRUG Theraflu Warming Relief Daytime Severe Cold And Cough Acetaminophen, Dextromethorphan HBr, Phenylepherine HCl SYRUP ORAL 20070504 OTC MONOGRAPH FINAL part341 Novartis Consumer Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 0043-0483_e8537c20-66d4-41a7-a92a-32eeac6a026d 0043-0483 HUMAN OTC DRUG Theraflu Flu and Chest Congestion Acetaminophen, Guaifenesin POWDER, FOR SOLUTION ORAL 20060623 OTC MONOGRAPH FINAL part341 Novartis Consumer Health ACETAMINOPHEN; GUAIFENESIN 1000; 400 mg/1; mg/1 0043-6256_f705ff57-2dcb-4a1b-9871-9ab453852570 0043-6256 HUMAN OTC DRUG Theraflu Nighttime Severe Cold and Cough ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE POWDER, FOR SOLUTION ORAL 20120924 OTC MONOGRAPH FINAL part341 Novartis Consumer Health ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 0043-6257_919eece1-ed48-4003-b629-c5a6db24d211 0043-6257 HUMAN OTC DRUG Theraflu Daytime Severe Cold and Cough ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE POWDER, FOR SOLUTION ORAL 20120924 OTC MONOGRAPH FINAL part341 Novartis Consumer Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 0043-6265_db758d7e-10b4-42da-8ca9-86f74a93cb12 0043-6265 HUMAN OTC DRUG Theraflu Warming Relief Flu and Sore Throat Acetaminophen, Diphenhydramine HCl, Phenylepherine HCl SYRUP ORAL 20070703 OTC MONOGRAPH FINAL part341 Novartis Consumer Health ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL 0043-6296_8fcf13a1-8c7e-4454-a5fe-cca2e28a95d3 0043-6296 HUMAN OTC DRUG Theraflu Warming Relief Cold and Chest Congestion Acetaminophen, Guaifenesin and Phenylephrine HCl SYRUP ORAL 20050806 OTC MONOGRAPH FINAL part341 Novartis Consumer Health ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/15mL; mg/15mL; mg/15mL 0046-0749_eaad8e44-f510-4b8c-a5da-c6f0cd29b466 0046-0749 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19561201 NDA NDA010402 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED 25 mg/5mL Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 0046-0872_a0f0d49c-e098-46be-b60a-af7946f33b7d 0046-0872 HUMAN PRESCRIPTION DRUG Premarin Vaginal conjugated estrogens CREAM VAGINAL 19781101 NDA NDA020216 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED .625 mg/g Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 0046-1065_c816159b-3987-4164-87bf-8e4ce8e2c3fe 0046-1065 HUMAN PRESCRIPTION DRUG Phospholine Iodide Ophthalmic echothiophate iodide KIT 19591204 NDA NDA011963 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 0046-1100_8ad0ae7d-b73f-40ee-af80-3707bc997c95 0046-1100 HUMAN PRESCRIPTION DRUG Premarin ESTROGENS, CONJUGATED TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED .3 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 0046-1101_8ad0ae7d-b73f-40ee-af80-3707bc997c95 0046-1101 HUMAN PRESCRIPTION DRUG Premarin ESTROGENS, CONJUGATED TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED .45 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 0046-1102_8ad0ae7d-b73f-40ee-af80-3707bc997c95 0046-1102 HUMAN PRESCRIPTION DRUG Premarin ESTROGENS, CONJUGATED TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED .625 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 0046-1103_8ad0ae7d-b73f-40ee-af80-3707bc997c95 0046-1103 HUMAN PRESCRIPTION DRUG Premarin ESTROGENS, CONJUGATED TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED .9 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 0046-1104_8ad0ae7d-b73f-40ee-af80-3707bc997c95 0046-1104 HUMAN PRESCRIPTION DRUG Premarin ESTROGENS, CONJUGATED TABLET, FILM COATED ORAL 20040901 NDA NDA004782 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED 1.25 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 0046-1105_4de8777c-8c84-41fd-877c-9ba0fd7ce0c0 0046-1105 HUMAN PRESCRIPTION DRUG Prempro CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE TABLET, SUGAR COATED ORAL 20090921 NDA NDA020527 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .3; 1.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0046-1106_4de8777c-8c84-41fd-877c-9ba0fd7ce0c0 0046-1106 HUMAN PRESCRIPTION DRUG Prempro CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE TABLET, SUGAR COATED ORAL 20090921 NDA NDA020527 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .45; 1.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0046-1107_4de8777c-8c84-41fd-877c-9ba0fd7ce0c0 0046-1107 HUMAN PRESCRIPTION DRUG Prempro CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE TABLET, SUGAR COATED ORAL 20090921 NDA NDA020527 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .625; 2.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0046-1108_4de8777c-8c84-41fd-877c-9ba0fd7ce0c0 0046-1108 HUMAN PRESCRIPTION DRUG Prempro CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE TABLET, SUGAR COATED ORAL 20121203 NDA NDA020527 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .625; 2.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0046-2575_4de8777c-8c84-41fd-877c-9ba0fd7ce0c0 0046-2575 HUMAN PRESCRIPTION DRUG Premphase conjugated estrogens and medroxyprogesterone acetate KIT 20120301 NDA NDA020527 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 0046-2579_4de8777c-8c84-41fd-877c-9ba0fd7ce0c0 0046-2579 HUMAN PRESCRIPTION DRUG Premphase conjugated estrogens and medroxyprogesterone acetate KIT 19951201 NDA NDA020527 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 0049-0013_7facddcd-dd7e-4f56-9189-8347b7c1f382 0049-0013 HUMAN PRESCRIPTION DRUG UNASYN ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911122 NDA NDA050608 Roerig AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0049-0014_7facddcd-dd7e-4f56-9189-8347b7c1f382 0049-0014 HUMAN PRESCRIPTION DRUG UNASYN ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911122 NDA NDA050608 Roerig AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0049-0022_7facddcd-dd7e-4f56-9189-8347b7c1f382 0049-0022 HUMAN PRESCRIPTION DRUG UNASYN ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911122 NDA NDA050608 Roerig AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0049-0023_7facddcd-dd7e-4f56-9189-8347b7c1f382 0049-0023 HUMAN PRESCRIPTION DRUG UNASYN ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911122 NDA NDA050608 Roerig AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0049-0024_a7b34969-b914-475e-b782-1be3a6fabb82 0049-0024 HUMAN PRESCRIPTION DRUG UNASYN ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911122 NDA NDA050608 Roerig AMPICILLIN SODIUM; SULBACTAM SODIUM 100; 50 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0049-0031_7facddcd-dd7e-4f56-9189-8347b7c1f382 0049-0031 HUMAN PRESCRIPTION DRUG UNASYN ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911122 NDA NDA062901 Roerig AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0049-0032_7facddcd-dd7e-4f56-9189-8347b7c1f382 0049-0032 HUMAN PRESCRIPTION DRUG UNASYN ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911122 NDA NDA062901 Roerig AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0049-0052_ceb369b7-2071-4f64-bf14-c0ee76a6e869 0049-0052 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20131101 NDA NDA020825 Roerig ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 0049-0054_ceb369b7-2071-4f64-bf14-c0ee76a6e869 0049-0054 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20131101 NDA NDA020825 Roerig ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 0049-0056_ceb369b7-2071-4f64-bf14-c0ee76a6e869 0049-0056 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20131101 NDA NDA020825 Roerig ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 0049-0058_ceb369b7-2071-4f64-bf14-c0ee76a6e869 0049-0058 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20131101 NDA NDA020825 Roerig ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 0049-0114_1a027b8b-c30b-426b-9e77-447de0a633ca 0049-0114 HUMAN PRESCRIPTION DRUG ERAXIS ANIDULAFUNGIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20060217 NDA NDA021632 Roerig ANIDULAFUNGIN 50 mg/15mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] 0049-0116_1a027b8b-c30b-426b-9e77-447de0a633ca 0049-0116 HUMAN PRESCRIPTION DRUG ERAXIS ANIDULAFUNGIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20060217 NDA NDA021632 Roerig ANIDULAFUNGIN 100 mg/30mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] 0049-0170_e0b0a85f-8400-43e6-8bc9-01ba651bd6c3 0049-0170 HUMAN PRESCRIPTION DRUG Glucotrol XL glipizide TABLET, EXTENDED RELEASE ORAL 20130715 NDA NDA020329 Roerig GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0049-0174_e0b0a85f-8400-43e6-8bc9-01ba651bd6c3 0049-0174 HUMAN PRESCRIPTION DRUG Glucotrol XL glipizide TABLET, EXTENDED RELEASE ORAL 20131001 NDA NDA020329 Roerig GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0049-0178_e0b0a85f-8400-43e6-8bc9-01ba651bd6c3 0049-0178 HUMAN PRESCRIPTION DRUG Glucotrol XL glipizide TABLET, EXTENDED RELEASE ORAL 20130509 NDA NDA020329 Roerig GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0049-0520_4f711558-a54a-482f-8dbb-ccbbcf197e28 0049-0520 HUMAN PRESCRIPTION DRUG Pfizerpen penicillin G potassium POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRATHECAL; INTRAVENOUS 20100601 ANDA ANDA060657 Roerig PENICILLIN G POTASSIUM 5000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0049-0520_95c40455-d2fe-40c2-ba2c-765c85f21518 0049-0520 HUMAN PRESCRIPTION DRUG Pfizerpen penicillin G potassium POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRATHECAL; INTRAVENOUS 20100601 ANDA ANDA060657 Roerig PENICILLIN G POTASSIUM 5000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0049-0520_b6b4775b-cb59-4787-b2da-bb5efc5e407d 0049-0520 HUMAN PRESCRIPTION DRUG Pfizerpen penicillin G potassium POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRATHECAL; INTRAVENOUS 20100601 ANDA ANDA060657 Roerig PENICILLIN G POTASSIUM 5000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0049-0530_4f711558-a54a-482f-8dbb-ccbbcf197e28 0049-0530 HUMAN PRESCRIPTION DRUG Pfizerpen penicillin G potassium POWDER, FOR SOLUTION INTRAVENOUS 20100601 ANDA ANDA060657 Roerig PENICILLIN G POTASSIUM 20000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0049-0530_95c40455-d2fe-40c2-ba2c-765c85f21518 0049-0530 HUMAN PRESCRIPTION DRUG Pfizerpen penicillin G potassium POWDER, FOR SOLUTION INTRAVENOUS 20100601 ANDA ANDA060657 Roerig PENICILLIN G POTASSIUM 20000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0049-0530_b6b4775b-cb59-4787-b2da-bb5efc5e407d 0049-0530 HUMAN PRESCRIPTION DRUG Pfizerpen penicillin G potassium POWDER, FOR SOLUTION INTRAVENOUS 20100601 ANDA ANDA060657 Roerig PENICILLIN G POTASSIUM 20000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0049-1550_e0b0a85f-8400-43e6-8bc9-01ba651bd6c3 0049-1550 HUMAN PRESCRIPTION DRUG Glucotrol XL glipizide TABLET, EXTENDED RELEASE ORAL 19940426 NDA NDA020329 Roerig GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0049-1560_e0b0a85f-8400-43e6-8bc9-01ba651bd6c3 0049-1560 HUMAN PRESCRIPTION DRUG Glucotrol XL glipizide TABLET, EXTENDED RELEASE ORAL 19990410 NDA NDA020329 Roerig GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0049-2100_332740ec-d49a-4564-92fa-9446a131c20c 0049-2100 HUMAN PRESCRIPTION DRUG Antivert MECLIZINE HYDROCHLORIDE TABLET ORAL 19970411 NDA NDA010721 Roerig MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 0049-2110_332740ec-d49a-4564-92fa-9446a131c20c 0049-2110 HUMAN PRESCRIPTION DRUG Antivert MECLIZINE HYDROCHLORIDE TABLET ORAL 19970411 NDA NDA010721 Roerig MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 0049-2140_332740ec-d49a-4564-92fa-9446a131c20c 0049-2140 HUMAN PRESCRIPTION DRUG Antivert MECLIZINE HYDROCHLORIDE TABLET ORAL 19970411 NDA NDA010721 Roerig MECLIZINE HYDROCHLORIDE 50 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 0049-2330_721f4d21-9c26-42a2-ad57-d5ee3584746c 0049-2330 HUMAN PRESCRIPTION DRUG Relpax eletriptan hydrobromide TABLET, FILM COATED ORAL 20021226 NDA NDA021016 Roerig ELETRIPTAN HYDROBROMIDE 20 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0049-2340_721f4d21-9c26-42a2-ad57-d5ee3584746c 0049-2340 HUMAN PRESCRIPTION DRUG Relpax eletriptan hydrobromide TABLET, FILM COATED ORAL 20021226 NDA NDA021016 Roerig ELETRIPTAN HYDROBROMIDE 40 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0049-2710_5d793492-6ce4-4e31-b21e-758072b071b9 0049-2710 HUMAN PRESCRIPTION DRUG Cardura XL doxazosin mesylate TABLET, MULTILAYER, EXTENDED RELEASE ORAL 20050222 NDA NDA021269 Roerig DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0049-2720_5d793492-6ce4-4e31-b21e-758072b071b9 0049-2720 HUMAN PRESCRIPTION DRUG Cardura XL doxazosin mesylate TABLET, MULTILAYER, EXTENDED RELEASE ORAL 20050222 NDA NDA021269 Roerig DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0049-2750_81ab70e7-368a-40a8-b310-4d2d3180fac9 0049-2750 HUMAN PRESCRIPTION DRUG Cardura doxazosin mesylate TABLET ORAL 19901102 NDA NDA019668 Roerig DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0049-2760_81ab70e7-368a-40a8-b310-4d2d3180fac9 0049-2760 HUMAN PRESCRIPTION DRUG Cardura doxazosin mesylate TABLET ORAL 19901102 NDA NDA019668 Roerig DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0049-2770_81ab70e7-368a-40a8-b310-4d2d3180fac9 0049-2770 HUMAN PRESCRIPTION DRUG Cardura doxazosin mesylate TABLET ORAL 19901102 NDA NDA019668 Roerig DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0049-2780_81ab70e7-368a-40a8-b310-4d2d3180fac9 0049-2780 HUMAN PRESCRIPTION DRUG Cardura doxazosin mesylate TABLET ORAL 19901102 NDA NDA019668 Roerig DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0049-3160_652897a0-a789-4b65-90ac-0574c129b809 0049-3160 HUMAN PRESCRIPTION DRUG VFEND voriconazole POWDER, FOR SUSPENSION ORAL 20030328 NDA NDA021630 Roerig VORICONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0049-3170_652897a0-a789-4b65-90ac-0574c129b809 0049-3170 HUMAN PRESCRIPTION DRUG VFEND voriconazole TABLET, FILM COATED ORAL 20030328 NDA NDA021266 Roerig VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0049-3180_652897a0-a789-4b65-90ac-0574c129b809 0049-3180 HUMAN PRESCRIPTION DRUG VFEND voriconazole TABLET, FILM COATED ORAL 20030328 NDA NDA021266 Roerig VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0049-3190_3f501dc1-b6f1-4089-ba2a-f56408234858 0049-3190 HUMAN PRESCRIPTION DRUG VFEND VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20020524 NDA NDA021267 Roerig VORICONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0049-3190_652897a0-a789-4b65-90ac-0574c129b809 0049-3190 HUMAN PRESCRIPTION DRUG VFEND voriconazole INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20030328 NDA NDA021267 Roerig VORICONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0049-3190_b372731b-600b-49e9-941b-caeef9a0381b 0049-3190 HUMAN PRESCRIPTION DRUG VFEND VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20121024 NDA NDA021267 Roerig VORICONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0049-3410_d0493a66-2c59-42b1-875b-625ebde75c3f 0049-3410 HUMAN PRESCRIPTION DRUG Diflucan fluconazole TABLET ORAL 19900129 NDA NDA019949 Roerig FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0049-3420_d0493a66-2c59-42b1-875b-625ebde75c3f 0049-3420 HUMAN PRESCRIPTION DRUG Diflucan fluconazole TABLET ORAL 19900129 NDA NDA019949 Roerig FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0049-3430_d0493a66-2c59-42b1-875b-625ebde75c3f 0049-3430 HUMAN PRESCRIPTION DRUG Diflucan fluconazole TABLET ORAL 19900129 NDA NDA019949 Roerig FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0049-3440_d0493a66-2c59-42b1-875b-625ebde75c3f 0049-3440 HUMAN PRESCRIPTION DRUG Diflucan fluconazole POWDER, FOR SUSPENSION ORAL 19931223 NDA NDA020090 Roerig FLUCONAZOLE 350 mg/35mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0049-3450_d0493a66-2c59-42b1-875b-625ebde75c3f 0049-3450 HUMAN PRESCRIPTION DRUG Diflucan fluconazole POWDER, FOR SUSPENSION ORAL 19931223 NDA NDA020090 Roerig FLUCONAZOLE 1400 mg/35mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0049-3500_d0493a66-2c59-42b1-875b-625ebde75c3f 0049-3500 HUMAN PRESCRIPTION DRUG Diflucan fluconazole TABLET ORAL 19900129 NDA NDA019949 Roerig FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0049-3920_ceb369b7-2071-4f64-bf14-c0ee76a6e869 0049-3920 HUMAN PRESCRIPTION DRUG Geodon ziprasidone mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20031223 NDA NDA020919 Roerig ZIPRASIDONE MESYLATE 20 mg/mL Atypical Antipsychotic [EPC] 0049-3960_ceb369b7-2071-4f64-bf14-c0ee76a6e869 0049-3960 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Roerig ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 0049-3970_ceb369b7-2071-4f64-bf14-c0ee76a6e869 0049-3970 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Roerig ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 0049-3980_ceb369b7-2071-4f64-bf14-c0ee76a6e869 0049-3980 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Roerig ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 0049-3990_ceb369b7-2071-4f64-bf14-c0ee76a6e869 0049-3990 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Roerig ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 0049-4110_99e51107-91c4-4e7c-ae74-14c383ca6bda 0049-4110 HUMAN PRESCRIPTION DRUG Glucotrol glipizide TABLET ORAL 19840508 NDA NDA017783 Roerig GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0049-4120_99e51107-91c4-4e7c-ae74-14c383ca6bda 0049-4120 HUMAN PRESCRIPTION DRUG Glucotrol glipizide TABLET ORAL 19840508 NDA NDA017783 Roerig GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0049-4190_8e9dfc73-06a4-4d12-a385-6abacdb840ec 0049-4190 HUMAN PRESCRIPTION DRUG VFEND VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20121024 NDA NDA021267 Roerig VORICONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0049-4900_7e9173f2-fb30-4c4c-aae9-96421c24bf2c 0049-4900 HUMAN PRESCRIPTION DRUG Zoloft sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Roerig SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0049-4910_7e9173f2-fb30-4c4c-aae9-96421c24bf2c 0049-4910 HUMAN PRESCRIPTION DRUG Zoloft sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Roerig SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0049-4940_7e9173f2-fb30-4c4c-aae9-96421c24bf2c 0049-4940 HUMAN PRESCRIPTION DRUG Zoloft sertraline hydrochloride SOLUTION, CONCENTRATE ORAL 19920211 NDA NDA020990 Roerig SERTRALINE HYDROCHLORIDE 20 mg/mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0049-4960_7e9173f2-fb30-4c4c-aae9-96421c24bf2c 0049-4960 HUMAN PRESCRIPTION DRUG Zoloft sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Roerig SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0049-5460_a9f98a5e-8c61-4c99-8801-b477a5b8293f 0049-5460 HUMAN PRESCRIPTION DRUG Vistaril hydroxyzine hydrochloride SOLUTION INTRAMUSCULAR 19570918 NDA NDA011111 Roerig HYDROXYZINE HYDROCHLORIDE 50 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0049-5710_a2746fad-d967-413b-8abc-228056a1be6c 0049-5710 HUMAN PRESCRIPTION DRUG Navane Thiothixene CAPSULE ORAL 19670724 NDA NDA016584 Roerig THIOTHIXENE 1 mg/1 Typical Antipsychotic [EPC] 0049-5720_a2746fad-d967-413b-8abc-228056a1be6c 0049-5720 HUMAN PRESCRIPTION DRUG Navane Thiothixene CAPSULE ORAL 19670724 NDA NDA016584 Roerig THIOTHIXENE 2 mg/1 Typical Antipsychotic [EPC] 0049-5730_a2746fad-d967-413b-8abc-228056a1be6c 0049-5730 HUMAN PRESCRIPTION DRUG Navane Thiothixene CAPSULE ORAL 19670724 NDA NDA016584 Roerig THIOTHIXENE 5 mg/1 Typical Antipsychotic [EPC] 0049-5740_a2746fad-d967-413b-8abc-228056a1be6c 0049-5740 HUMAN PRESCRIPTION DRUG Navane Thiothixene CAPSULE ORAL 19670724 NDA NDA016584 Roerig THIOTHIXENE 10 mg/1 Typical Antipsychotic [EPC] 0049-5770_a2746fad-d967-413b-8abc-228056a1be6c 0049-5770 HUMAN PRESCRIPTION DRUG Navane Thiothixene CAPSULE ORAL 19670724 NDA NDA016584 Roerig THIOTHIXENE 20 mg/1 Typical Antipsychotic [EPC] 0051-0021_152cd664-8ede-40f7-25ee-74a00f025736 0051-0021 HUMAN PRESCRIPTION DRUG Marinol Dronabinol CAPSULE ORAL 20100713 NDA NDA018651 AbbVie Inc. DRONABINOL 2.5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 0051-0022_152cd664-8ede-40f7-25ee-74a00f025736 0051-0022 HUMAN PRESCRIPTION DRUG Marinol Dronabinol CAPSULE ORAL 20100713 NDA NDA018651 AbbVie Inc. DRONABINOL 5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 0051-0023_152cd664-8ede-40f7-25ee-74a00f025736 0051-0023 HUMAN PRESCRIPTION DRUG Marinol Dronabinol CAPSULE ORAL 20100713 NDA NDA018651 AbbVie Inc. DRONABINOL 10 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 0051-8425_dbacb078-d63a-5011-85b5-7ad50820ee1c 0051-8425 HUMAN PRESCRIPTION DRUG Androgel Testosterone GEL TRANSDERMAL 20110314 NDA NDA021015 AbbVie Inc. TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0051-8450_dbacb078-d63a-5011-85b5-7ad50820ee1c 0051-8450 HUMAN PRESCRIPTION DRUG Androgel Testosterone GEL TRANSDERMAL 20110314 NDA NDA021015 AbbVie Inc. TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0051-8462_8f35f73d-9b04-e28e-dc68-2d73cc0e773d 0051-8462 HUMAN PRESCRIPTION DRUG Androgel Testosterone GEL TRANSDERMAL 20110429 NDA NDA022309 AbbVie Inc. TESTOSTERONE 16.2 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0051-8488_dbacb078-d63a-5011-85b5-7ad50820ee1c 0051-8488 HUMAN PRESCRIPTION DRUG Androgel Testosterone GEL TRANSDERMAL 20110314 NDA NDA021015 AbbVie Inc. TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0052-0105_2b05ea6f-ca8d-4192-8d59-467995b41af3 0052-0105 HUMAN PRESCRIPTION DRUG REMERON MIRTAZAPINE TABLET, FILM COATED ORAL 19960614 NDA NDA020415 Organon USA Inc. MIRTAZAPINE 15 mg/1 0052-0106_fb539d14-cac6-4d6b-be8e-88c9d914b7f2 0052-0106 HUMAN PRESCRIPTION DRUG REMERONSOLTAB MIRTAZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20010112 NDA NDA021208 Organon USA Inc. MIRTAZAPINE 15 mg/1 0052-0107_2b05ea6f-ca8d-4192-8d59-467995b41af3 0052-0107 HUMAN PRESCRIPTION DRUG REMERON MIRTAZAPINE TABLET, FILM COATED ORAL 19960614 NDA NDA020415 Organon USA Inc. MIRTAZAPINE 30 mg/1 0052-0108_fb539d14-cac6-4d6b-be8e-88c9d914b7f2 0052-0108 HUMAN PRESCRIPTION DRUG REMERONSOLTAB MIRTAZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20010112 NDA NDA021208 Organon USA Inc. MIRTAZAPINE 30 mg/1 0052-0109_2b05ea6f-ca8d-4192-8d59-467995b41af3 0052-0109 HUMAN PRESCRIPTION DRUG REMERON MIRTAZAPINE TABLET, FILM COATED ORAL 19970311 NDA NDA020415 Organon USA Inc. MIRTAZAPINE 45 mg/1 0052-0110_fb539d14-cac6-4d6b-be8e-88c9d914b7f2 0052-0110 HUMAN PRESCRIPTION DRUG REMERONSOLTAB MIRTAZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20010112 NDA NDA021208 Organon USA Inc. MIRTAZAPINE 45 mg/1 0052-0118_da55e2fe-c473-46cc-a4b4-d31c8e63d148 0052-0118 HUMAN PRESCRIPTION DRUG SAPHRIS Asenapine Maleate TABLET SUBLINGUAL 20090813 NDA NDA022117 Organon Pharmaceuticals USA ASENAPINE MALEATE 5 mg/1 Atypical Antipsychotic [EPC] 0052-0119_da55e2fe-c473-46cc-a4b4-d31c8e63d148 0052-0119 HUMAN PRESCRIPTION DRUG SAPHRIS Asenapine Maleate TABLET SUBLINGUAL 20090813 NDA NDA022117 Organon Pharmaceuticals USA ASENAPINE MALEATE 10 mg/1 Atypical Antipsychotic [EPC] 0052-0261_08212edd-44be-4875-825c-9f1997e4c366 0052-0261 HUMAN PRESCRIPTION DRUG Desogen desogestrel and ethinyl estradiol KIT 20100610 NDA NDA020071 Organon USA Inc. 0052-0272_487fd1c9-8394-4d1e-8e98-fd0aef326221 0052-0272 HUMAN PRESCRIPTION DRUG IMPLANON etonogestrel IMPLANT SUBCUTANEOUS 20110906 NDA NDA021529 Organon USA Inc. ETONOGESTREL 68 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0052-0273_5dd9ac75-3bc7-4e99-8ad1-3187f78f6605 0052-0273 HUMAN PRESCRIPTION DRUG NuvaRing etonogestrel and ethinyl estradiol INSERT, EXTENDED RELEASE VAGINAL 20011003 NDA NDA021187 Organon USA Inc. ETHINYL ESTRADIOL; ETONOGESTREL .015; .12 mg/d; mg/d Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0052-0274_79a9ebeb-f1ac-467e-bdf2-2a9d52795e46 0052-0274 HUMAN PRESCRIPTION DRUG Nexplanon etonogestrel IMPLANT SUBCUTANEOUS 20060717 NDA NDA021529 Organon USA Inc. ETONOGESTREL 68 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0052-0283_4080c852-552b-4f11-b927-6cc73b30ea3c 0052-0283 HUMAN PRESCRIPTION DRUG CYCLESSA desogestrel and ethinyl estradiol KIT 20001220 NDA NDA021090 Organon USA Inc. 0052-0301_c158e3b8-cf8d-42e7-9a3b-24ca69fbdd30 0052-0301 HUMAN PRESCRIPTION DRUG Ganirelix Acetate Ganirelix Acetate INJECTION, SOLUTION SUBCUTANEOUS 19990729 NDA NDA021057 Organon USA Inc. GANIRELIX ACETATE 250 ug/.5mL Decreased GnRH Secretion [PE],Gonadotropin Releasing Hormone Antagonist [EPC],Gonadotropin Releasing Hormone Receptor Antagonists [MoA] 0052-0308_fc24862f-3cac-4a57-b1d7-155b87a54a6b 0052-0308 HUMAN PRESCRIPTION DRUG Follistim AQ follitropin INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20100628 NDA NDA021273 Organon USA Inc. FOLLITROPIN 75 [iU]/.5mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] 0052-0309_fc24862f-3cac-4a57-b1d7-155b87a54a6b 0052-0309 HUMAN PRESCRIPTION DRUG Follistim AQ follitropin INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20100628 NDA NDA021273 Organon USA Inc. FOLLITROPIN 150 [iU]/.5mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] 0052-0313_e62d5590-aa17-468f-9f84-7d611347e9cd 0052-0313 HUMAN PRESCRIPTION DRUG Follistim AQ follitropin INJECTION, SOLUTION SUBCUTANEOUS 20100628 NDA NDA021211 Organon USA Inc. FOLLITROPIN 350 [iU]/.42mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] 0052-0315_3dab7afd-ea38-46bb-9c0d-f0af687f6e9d 0052-0315 HUMAN PRESCRIPTION DRUG Pregnyl CHORIOGONADOTROPIN ALFA KIT 19761020 NDA NDA017692 Organon USA Inc. 0052-0316_e62d5590-aa17-468f-9f84-7d611347e9cd 0052-0316 HUMAN PRESCRIPTION DRUG Follistim AQ follitropin INJECTION, SOLUTION SUBCUTANEOUS 20100628 NDA NDA021211 Organon USA Inc. FOLLITROPIN 650 [iU]/.78mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] 0052-0326_e62d5590-aa17-468f-9f84-7d611347e9cd 0052-0326 HUMAN PRESCRIPTION DRUG Follistim AQ follitropin INJECTION, SOLUTION SUBCUTANEOUS 20100628 NDA NDA021211 Organon USA Inc. FOLLITROPIN 975 [iU]/1.17mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] 0052-0450_a3e9ac47-97ae-479b-90a5-33e31e3d7b9a 0052-0450 HUMAN PRESCRIPTION DRUG Zemuron rocuronium bromide INJECTION, SOLUTION INTRAVENOUS 19940317 NDA NDA020214 Organon USA Inc. ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0052-0602_f772957c-59c6-41b7-826e-ca8bd3c4b5cc 0052-0602 HUMAN PRESCRIPTION DRUG TICE BCG BACILLUS CALMETTE-GUERIN POWDER, FOR SUSPENSION INTRAVESICAL 19900824 BLA BLA102821 Organon USA Inc. BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN 50 mg/50mL Live Attenuated Bacillus Calmette-Guerin Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],BCG Vaccine [Chemical/Ingredient],Live Attenuated Bacillus Calmette-Guerin Immunotherapy [EPC],Increased Macrophage Proliferation [PE],Increased Immunologically Active Molecule Activity [PE] 0052-0603_ffcb1677-5fc1-4969-8ea6-8e12163527d3 0052-0603 VACCINE BCG VACCINE BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS 19890621 BLA BLA103050 Organon USA Inc. BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN 50 mg/1 Live Attenuated Bacillus Calmette-Guerin Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],BCG Vaccine [Chemical/Ingredient],Live Attenuated Bacillus Calmette-Guerin Immunotherapy [EPC],Increased Macrophage Proliferation [PE],Increased Immunologically Active Molecule Activity [PE] 0052-2139_da55e2fe-c473-46cc-a4b4-d31c8e63d148 0052-2139 HUMAN PRESCRIPTION DRUG SAPHRIS Asenapine Maleate TABLET SUBLINGUAL 20100621 NDA NDA022117 Organon Pharmaceuticals USA ASENAPINE MALEATE 5 mg/1 Atypical Antipsychotic [EPC] 0052-2142_da55e2fe-c473-46cc-a4b4-d31c8e63d148 0052-2142 HUMAN PRESCRIPTION DRUG SAPHRIS Asenapine Maleate TABLET SUBLINGUAL 20100621 NDA NDA022117 Organon Pharmaceuticals USA ASENAPINE MALEATE 10 mg/1 Atypical Antipsychotic [EPC] 0052-4330_79a9ebeb-f1ac-467e-bdf2-2a9d52795e46 0052-4330 HUMAN PRESCRIPTION DRUG Nexplanon etonogestrel IMPLANT SUBCUTANEOUS 20130927 NDA NDA021529 Organon USA Inc. ETONOGESTREL 68 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0053-6232_b441d459-3d1b-44c7-ae3e-eecdce5656d9 0053-6232 PLASMA DERIVATIVE Mononine coagulation factor IX human KIT 19920820 BLA BLA103957 CSL Behring LLC 0053-6233_b441d459-3d1b-44c7-ae3e-eecdce5656d9 0053-6233 PLASMA DERIVATIVE Mononine coagulation factor IX human KIT 19920820 BLA BLA103957 CSL Behring LLC 0053-6871_288faa68-9d71-441c-8fd0-6b6aeda2070f 0053-6871 HUMAN PRESCRIPTION DRUG Stimate desmopressin acetate SPRAY, METERED NASAL 20110916 NDA NDA020355 CSL Behring LLC DESMOPRESSIN ACETATE 1.5 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 0053-7201_32730430-18c1-4bcb-8faa-d3272ceb1256 0053-7201 PLASMA DERIVATIVE Zemaira alpha-1-proteinase inhibitor human KIT 20030708 BLA BLA125078 CSL Behring LLC 0053-7596_be002d84-ee9f-4a1e-a396-3a59a4e5b834 0053-7596 HUMAN PRESCRIPTION DRUG Vivaglobin Human Immunoglobulin G SOLUTION SUBCUTANEOUS 20060109 BLA BLA125115 CSL Behring LLC HUMAN IMMUNOGLOBULIN G 160 mg/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 0053-7631_aef1f9f9-aece-492d-9c09-8099ea79c0cc 0053-7631 PLASMA DERIVATIVE Monoclate-P ANTIHEMOPHILIC FACTOR HUMAN KIT 19900530 BLA BLA103953 CSL Behring LLC 0053-7632_aef1f9f9-aece-492d-9c09-8099ea79c0cc 0053-7632 PLASMA DERIVATIVE Monoclate-P ANTIHEMOPHILIC FACTOR HUMAN KIT 19900530 BLA BLA103953 CSL Behring LLC 0053-7633_aef1f9f9-aece-492d-9c09-8099ea79c0cc 0053-7633 PLASMA DERIVATIVE Monoclate-P ANTIHEMOPHILIC FACTOR HUMAN KIT 19900530 BLA BLA103953 CSL Behring LLC 0053-7634_aef1f9f9-aece-492d-9c09-8099ea79c0cc 0053-7634 PLASMA DERIVATIVE Monoclate-P ANTIHEMOPHILIC FACTOR HUMAN KIT 20040304 BLA BLA103953 CSL Behring LLC 0053-7670_8c05c89c-bfb6-490e-804f-33d8af768315 0053-7670 PLASMA DERIVATIVE Albuminar-5 Albumin (Human) SOLUTION INTRAVENOUS 20090106 BLA BLA103955 CSL Behring LLC ALBUMIN HUMAN 2.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 0053-7680_7c29155f-1295-4bf8-8a93-ff1ea3ed6999 0053-7680 PLASMA DERIVATIVE Albuminar-25 Albumin (Human) SOLUTION INTRAVENOUS 20090106 BLA BLA103955 CSL Behring LLC ALBUMIN HUMAN 25 g/100mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 0053-7695_37faea5f-f558-4102-a9db-93b1510a22b7 0053-7695 PLASMA DERIVATIVE Albuminar-20 Albumin (Human) SOLUTION INTRAVENOUS 20090106 BLA BLA103955 CSL Behring LLC ALBUMIN HUMAN 20 g/100mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 0053-8131_d466b491-d9d2-4332-a180-01f36b46a96c 0053-8131 PLASMA DERIVATIVE Helixate FS Antihemophilic Factor, Recombinant KIT 20000818 BLA BLA103332 CSL Behring LLC 0053-8132_d466b491-d9d2-4332-a180-01f36b46a96c 0053-8132 PLASMA DERIVATIVE Helixate FS Antihemophilic Factor, Recombinant KIT 20000818 BLA BLA103332 CSL Behring LLC 0053-8133_d466b491-d9d2-4332-a180-01f36b46a96c 0053-8133 PLASMA DERIVATIVE Helixate FS Antihemophilic Factor, Recombinant KIT 20000818 BLA BLA103332 CSL Behring LLC 0053-8134_d466b491-d9d2-4332-a180-01f36b46a96c 0053-8134 PLASMA DERIVATIVE Helixate FS Antihemophilic Factor, Recombinant KIT 20080116 BLA BLA103332 CSL Behring LLC 0053-8135_d466b491-d9d2-4332-a180-01f36b46a96c 0053-8135 PLASMA DERIVATIVE Helixate FS Antihemophilic Factor, Recombinant KIT 20090731 BLA BLA103332 CSL Behring LLC 0054-0002_0f992932-3f41-4700-8fb3-462db3786c4b 0054-0002 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20040729 ANDA ANDA076246 Roxane Laboratories, Inc FLUCONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0054-0003_0f992932-3f41-4700-8fb3-462db3786c4b 0054-0003 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20040729 ANDA ANDA076246 Roxane Laboratories, Inc FLUCONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0054-0007_a7fcdf88-564e-45d9-8c41-ae135262ef89 0054-0007 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE ORAL 20060327 ANDA ANDA076917 Roxane Laboratories, Inc. CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0054-0010_29867cbe-27b3-4979-afd5-39c3f6aa8a01 0054-0010 HUMAN PRESCRIPTION DRUG Flecainide Acetate flecainide acetate TABLET ORAL 20030114 ANDA ANDA076278 Roxane Laboratories, Inc. FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] 0054-0011_29867cbe-27b3-4979-afd5-39c3f6aa8a01 0054-0011 HUMAN PRESCRIPTION DRUG Flecainide Acetate flecainide acetate TABLET ORAL 20030114 ANDA ANDA076278 Roxane Laboratories, Inc. FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] 0054-0012_29867cbe-27b3-4979-afd5-39c3f6aa8a01 0054-0012 HUMAN PRESCRIPTION DRUG Flecainide Acetate flecainide acetate TABLET ORAL 20030114 ANDA ANDA076278 Roxane Laboratories, Inc. FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] 0054-0017_645709c0-48d1-444f-8d51-f38b7109ecf3 0054-0017 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA084122 Roxane Laboratories, Inc. PREDNISONE 10 mg/1 0054-0018_645709c0-48d1-444f-8d51-f38b7109ecf3 0054-0018 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA087342 Roxane Laboratories, Inc. PREDNISONE 20 mg/1 0054-0019_645709c0-48d1-444f-8d51-f38b7109ecf3 0054-0019 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030314 ANDA ANDA084283 Roxane Laboratories, Inc. PREDNISONE 50 mg/1 0054-0020_d08da757-0760-4837-af41-688fe24d76da 0054-0020 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20040105 ANDA ANDA076691 Roxane Laboratories, Inc LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] 0054-0021_a71bcc65-08c0-44be-b78e-c062631185b4 0054-0021 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20041028 ANDA ANDA076832 Roxane Laboratories, Inc LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 0054-0025_2e7c85a4-b3ba-4436-850d-04e1a29075e5 0054-0025 HUMAN PRESCRIPTION DRUG Mefloquine Hydrochloride mefloquine hydrochloride TABLET ORAL 20041001 ANDA ANDA076523 Roxane Laboratories, Inc. MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC] 0054-0028_9ac3e991-ff0b-4923-90a7-e5d53a9de648 0054-0028 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20050517 ANDA ANDA077024 Roxane Laboratories, Inc CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0054-0036_ab1d41d9-7e92-49ce-8ba0-cc2003667cd8 0054-0036 HUMAN PRESCRIPTION DRUG Clarithromycin clarithromycin TABLET, COATED ORAL 20041122 ANDA ANDA065178 Roxane Laboratories, Inc CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0054-0037_ab1d41d9-7e92-49ce-8ba0-cc2003667cd8 0054-0037 HUMAN PRESCRIPTION DRUG Clarithromycin clarithromycin TABLET, COATED ORAL 20040525 ANDA ANDA065178 Roxane Laboratories, Inc CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0054-0044_9ac3e991-ff0b-4923-90a7-e5d53a9de648 0054-0044 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20110105 ANDA ANDA077024 Roxane Laboratories, Inc CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0054-0045_e39e571b-47a1-48d1-853c-c51acb6af663 0054-0045 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SPRAY NASAL 20031105 ANDA ANDA076664 Roxane Laboratories, Inc IPRATROPIUM BROMIDE 21 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0054-0046_5a5389c8-d149-4f65-8216-8fe690eb3a2f 0054-0046 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SPRAY NASAL 20031115 ANDA ANDA076598 Roxane Laboratories, Inc IPRATROPIUM BROMIDE 42 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0054-0052_1bc145d8-4484-4068-9bf2-8c4683d52e36 0054-0052 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET ORAL 20050919 ANDA ANDA076844 Roxane Laboratories, Inc ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0054-0056_a470fd86-49f3-4bd0-bd2d-ab52c32e8acf 0054-0056 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride TABLET ORAL 20041222 20160311 ANDA ANDA076963 Roxane Laboratories, Inc PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 0054-0057_7fdbf456-3792-48a4-98e7-a376a5678494 0054-0057 HUMAN PRESCRIPTION DRUG Digoxin Digoxin SOLUTION ORAL 20040826 NDA NDA021648 Roxane Laboratories, Inc DIGOXIN .05 mg/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0054-0062_2cd9d784-43dd-47d8-aa3c-66a851b27154 0054-0062 HUMAN PRESCRIPTION DRUG Citalopram Citalopram SOLUTION ORAL 20040525 ANDA ANDA065178 Roxane Laboratories, Inc CITALOPRAM HYDROBROMIDE 10 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0054-0063_4a2f52c1-3e95-4083-a27d-2aaf9844b253 0054-0063 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20090729 ANDA ANDA076904 Roxane Laboratories, Inc RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] 0054-0064_199daf0e-a7c9-4114-9180-b0a6f5edfc1e 0054-0064 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride SOLUTION ORAL 20061226 ANDA ANDA076960 Roxane Laboratories, Inc ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0054-0077_c5b24aa5-1bf5-4b7d-9220-564a80668209 0054-0077 HUMAN PRESCRIPTION DRUG TORSEMIDE TORSEMIDE TABLET ORAL 20050303 ANDA ANDA076943 Roxane Laboratories, Inc TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0054-0079_f1cba08b-2630-47a0-83d2-6f3665d84ed1 0054-0079 HUMAN PRESCRIPTION DRUG Balsalazide Disodium Balsalazide Disodium CAPSULE ORAL 20071228 ANDA ANDA077806 Roxane Laboratories, Inc BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 0054-0080_581f9d6d-026a-49ce-9f89-120bc3d439d6 0054-0080 HUMAN PRESCRIPTION DRUG Exemestane Exemestane TABLET, FILM COATED ORAL 20110401 ANDA ANDA077431 Roxane Laboratories, Inc EXEMESTANE 25 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 0054-0084_f8013bd1-c508-4ca8-bc70-ff4674f17e97 0054-0084 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20080606 ANDA ANDA077237 Roxane Laboratories, Inc ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 0054-0085_f8013bd1-c508-4ca8-bc70-ff4674f17e97 0054-0085 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20080606 ANDA ANDA077237 Roxane Laboratories, Inc ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 0054-0086_2028d564-a747-412d-afa6-f676555524e6 0054-0086 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070427 ANDA ANDA077214 Roxane Laboratories, Inc ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0054-0087_2028d564-a747-412d-afa6-f676555524e6 0054-0087 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070427 ANDA ANDA077214 Roxane Laboratories, Inc ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0054-0088_1ddf6426-9aca-49cf-93f8-479feb2c4ded 0054-0088 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20080226 ANDA ANDA077728 Roxane Laboratories, Inc CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0054-0097_786f6a4d-ee2c-4ce8-b3a1-b75339040fda 0054-0097 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20071009 ANDA ANDA077795 Roxane Laboratories, Inc OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0054-0098_786f6a4d-ee2c-4ce8-b3a1-b75339040fda 0054-0098 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20071009 ANDA ANDA077795 Roxane Laboratories, Inc OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0054-0099_786f6a4d-ee2c-4ce8-b3a1-b75339040fda 0054-0099 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20071009 ANDA ANDA077795 Roxane Laboratories, Inc OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0054-0100_44b8b5ec-4fe3-4076-aa42-4573a7ca415e 0054-0100 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070709 ANDA ANDA077262 Roxane Laboratories, Inc AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0054-0101_44b8b5ec-4fe3-4076-aa42-4573a7ca415e 0054-0101 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070709 ANDA ANDA077262 Roxane Laboratories, Inc AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0054-0102_44b8b5ec-4fe3-4076-aa42-4573a7ca415e 0054-0102 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070709 ANDA ANDA077262 Roxane Laboratories, Inc AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0054-0106_7ef5e23b-e5a0-441a-85d4-4b50a060ec9f 0054-0106 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 Roxane Laboratories, Inc RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0054-0107_7ef5e23b-e5a0-441a-85d4-4b50a060ec9f 0054-0107 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 Roxane Laboratories, Inc RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0054-0108_7ef5e23b-e5a0-441a-85d4-4b50a060ec9f 0054-0108 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 Roxane Laboratories, Inc RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0054-0109_7ef5e23b-e5a0-441a-85d4-4b50a060ec9f 0054-0109 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 Roxane Laboratories, Inc RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0054-0110_d70811f7-f7d0-442b-a5d8-1738212d41f6 0054-0110 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA090072 Roxane Laboratories, Inc. PERINDOPRIL ERBUMINE 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0054-0111_d70811f7-f7d0-442b-a5d8-1738212d41f6 0054-0111 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA090072 Roxane Laboratories, Inc. PERINDOPRIL ERBUMINE 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0054-0112_d70811f7-f7d0-442b-a5d8-1738212d41f6 0054-0112 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA090072 Roxane Laboratories, Inc. PERINDOPRIL ERBUMINE 8 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0054-0114_4400f9b9-a634-4ee1-bc54-cf10cbd29717 0054-0114 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET ORAL 20100524 ANDA ANDA078656 Roxane Laboratories, Inc VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0054-0115_4400f9b9-a634-4ee1-bc54-cf10cbd29717 0054-0115 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET ORAL 20100524 ANDA ANDA078656 Roxane Laboratories, Inc VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0054-0116_0a05317b-c7b0-444d-9bd5-21ddbfa3d6cf 0054-0116 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Roxane Laboratories, Inc ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0054-0117_0a05317b-c7b0-444d-9bd5-21ddbfa3d6cf 0054-0117 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Roxane Laboratories, Inc ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0054-0118_0a05317b-c7b0-444d-9bd5-21ddbfa3d6cf 0054-0118 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Roxane Laboratories, Inc ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0054-0119_0a05317b-c7b0-444d-9bd5-21ddbfa3d6cf 0054-0119 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Roxane Laboratories, Inc ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0054-0120_0a05317b-c7b0-444d-9bd5-21ddbfa3d6cf 0054-0120 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Roxane Laboratories, Inc ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0054-0121_0a05317b-c7b0-444d-9bd5-21ddbfa3d6cf 0054-0121 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Roxane Laboratories, Inc ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0054-0122_0a05317b-c7b0-444d-9bd5-21ddbfa3d6cf 0054-0122 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Roxane Laboratories, Inc ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0054-0123_7b68746e-fc5f-4148-a35e-6c18bee862eb 0054-0123 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA077459 Roxane Laboratories, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0054-0124_7b68746e-fc5f-4148-a35e-6c18bee862eb 0054-0124 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA077459 Roxane Laboratories, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0054-0125_7b68746e-fc5f-4148-a35e-6c18bee862eb 0054-0125 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA077459 Roxane Laboratories, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0054-0126_48ce361f-a3e7-4b9a-9cc1-790019e2cea8 0054-0126 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA077732 Roxane Laboratories, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0054-0127_48ce361f-a3e7-4b9a-9cc1-790019e2cea8 0054-0127 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA077732 Roxane Laboratories, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0054-0137_674e238f-643a-44fa-a474-6fe2e8e43692 0054-0137 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide Oral Solution Galantamine Hydrobromide Oral Solution SOLUTION ORAL 20090814 ANDA ANDA078185 Roxane Laboratories, Inc GALANTAMINE HYDROBROMIDE 4 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0054-0140_41b1a657-32cc-4036-8a25-2c363c2609bc 0054-0140 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20080507 ANDA ANDA078470 Roxane Laboratories, Inc ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 0054-0141_41b1a657-32cc-4036-8a25-2c363c2609bc 0054-0141 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20080507 ANDA ANDA078470 Roxane Laboratories, Inc ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 0054-0142_41b1a657-32cc-4036-8a25-2c363c2609bc 0054-0142 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20080507 ANDA ANDA078470 Roxane Laboratories, Inc ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 0054-0143_76f7d910-455c-4e41-a8a2-cfa38118d683 0054-0143 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride TABLET ORAL 20080516 ANDA ANDA077842 Roxane Laboratories, Inc GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0054-0163_2002c96c-9d91-4058-ab8d-98d2c85bdb50 0054-0163 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20080729 ANDA ANDA065410 Roxane Laboratories, Inc MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 0054-0164_064876a8-97d8-495e-8240-0df8ed2a97d1 0054-0164 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100628 ANDA ANDA078485 Roxane Laboratories, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 0054-0166_2002c96c-9d91-4058-ab8d-98d2c85bdb50 0054-0166 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET ORAL 20080729 ANDA ANDA065413 Roxane Laboratories, Inc MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 0054-0176_ac0167d4-3f1a-45f5-910c-4926946956b2 0054-0176 HUMAN PRESCRIPTION DRUG Buprenorphine HCl Buprenorphine HCl TABLET SUBLINGUAL 20091008 ANDA ANDA078633 Roxane Laboratories, Inc BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 0054-0177_ac0167d4-3f1a-45f5-910c-4926946956b2 0054-0177 HUMAN PRESCRIPTION DRUG Buprenorphine HCl Buprenorphine HCl TABLET SUBLINGUAL 20091008 ANDA ANDA078633 Roxane Laboratories, Inc BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 0054-0188_713db2c6-0544-4633-b874-cfbeaf93db89 0054-0188 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride and naloxone hydrochloride dihydrate buprenorphine hydrochloride and naloxone hydrochloride dihydrate TABLET SUBLINGUAL 20140627 ANDA ANDA203326 Roxane Laboratories, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 0054-0189_713db2c6-0544-4633-b874-cfbeaf93db89 0054-0189 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride and naloxone hydrochloride dihydrate buprenorphine hydrochloride and naloxone hydrochloride dihydrate TABLET SUBLINGUAL 20140627 ANDA ANDA203326 Roxane Laboratories, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 0054-0196_e00d8005-b761-4348-a1d2-90bc17c1700d 0054-0196 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET ORAL 20110103 ANDA ANDA090128 Roxane Laboratories, Inc. FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0054-0197_e00d8005-b761-4348-a1d2-90bc17c1700d 0054-0197 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET ORAL 20110103 ANDA ANDA090128 Roxane Laboratories, Inc. FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0054-0198_e00d8005-b761-4348-a1d2-90bc17c1700d 0054-0198 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET ORAL 20110103 ANDA ANDA090128 Roxane Laboratories, Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0054-0199_195d2176-fa12-44f4-977e-5920cfa743fb 0054-0199 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine SUSPENSION ORAL 20121003 ANDA ANDA201193 Roxane Laboratories, Inc OXCARBAZEPINE 300 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0054-0210_2e1c79e2-ae88-4cc0-8db3-85e520a42c58 0054-0210 HUMAN PRESCRIPTION DRUG Protriptyline Hydrochloride Protriptyline Hydrochloride TABLET ORAL 20080916 ANDA ANDA078913 Roxane Laboratories, Inc PROTRIPTYLINE HYDROCHLORIDE 5 mg/1 Tricyclic Antidepressant [EPC] 0054-0211_2e1c79e2-ae88-4cc0-8db3-85e520a42c58 0054-0211 HUMAN PRESCRIPTION DRUG Protriptyline Hydrochloride Protriptyline Hydrochloride TABLET ORAL 20080916 ANDA ANDA078913 Roxane Laboratories, Inc PROTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0054-0220_aac4fb7d-f9f6-4742-8ed8-1be38d89b1a3 0054-0220 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090749 Roxane Laboratories, Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 0054-0221_aac4fb7d-f9f6-4742-8ed8-1be38d89b1a3 0054-0221 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090120 Roxane Laboratories, Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 0054-0222_aac4fb7d-f9f6-4742-8ed8-1be38d89b1a3 0054-0222 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090120 Roxane Laboratories, Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 0054-0223_aac4fb7d-f9f6-4742-8ed8-1be38d89b1a3 0054-0223 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090120 Roxane Laboratories, Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 0054-0224_cac1eb83-3c78-4b43-8669-9d3c79b57cac 0054-0224 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090115 ANDA ANDA078582 Roxane Laboratories, Inc LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0054-0228_fb129d48-37b5-4aee-9fca-408b10bc5829 0054-0228 HUMAN PRESCRIPTION DRUG meloxicam meloxicam SUSPENSION ORAL 20011101 NDA AUTHORIZED GENERIC NDA021530 Roxane Laboratories, Inc. MELOXICAM 7.5 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0054-0229_aac4fb7d-f9f6-4742-8ed8-1be38d89b1a3 0054-0229 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090120 Roxane Laboratories, Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 0054-0230_aac4fb7d-f9f6-4742-8ed8-1be38d89b1a3 0054-0230 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090120 Roxane Laboratories, Inc. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 0054-0235_88f755b6-a949-48aa-a777-80512b94c638 0054-0235 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080317 NDA NDA022207 Roxane Laboratories, Inc MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0236_88f755b6-a949-48aa-a777-80512b94c638 0054-0236 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080317 NDA NDA022207 Roxane Laboratories, Inc MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0237_81d14a02-5271-4090-990e-74effd5ec392 0054-0237 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20080317 NDA NDA022195 Roxane Laboratories, Inc MORPHINE SULFATE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0238_81d14a02-5271-4090-990e-74effd5ec392 0054-0238 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20080317 NDA NDA022195 Roxane Laboratories, Inc MORPHINE SULFATE 20 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0243_a46e28cb-5a25-4313-bdd4-85cae244e149 0054-0243 HUMAN PRESCRIPTION DRUG Codeine sulfate codeine sulfate TABLET ORAL 20091001 NDA NDA022402 Roxane Laboratories, Inc CODEINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0244_a46e28cb-5a25-4313-bdd4-85cae244e149 0054-0244 HUMAN PRESCRIPTION DRUG Codeine sulfate codeine sulfate TABLET ORAL 20091001 NDA NDA022402 Roxane Laboratories, Inc CODEINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0245_a46e28cb-5a25-4313-bdd4-85cae244e149 0054-0245 HUMAN PRESCRIPTION DRUG Codeine sulfate codeine sulfate TABLET ORAL 20091001 NDA NDA022402 Roxane Laboratories, Inc CODEINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0250_17fd7c65-0614-4f2e-81b5-25ced8734558 0054-0250 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20121015 ANDA ANDA090201 Roxane Laboratories, Inc. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0054-0251_17fd7c65-0614-4f2e-81b5-25ced8734558 0054-0251 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20121015 ANDA ANDA090201 Roxane Laboratories, Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0054-0252_17fd7c65-0614-4f2e-81b5-25ced8734558 0054-0252 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20121015 ANDA ANDA090201 Roxane Laboratories, Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0054-0254_aaecddd3-6e85-4068-af44-76f2682629b4 0054-0254 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20121015 ANDA ANDA090351 Roxane Laboratories, Inc. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0054-0255_aaecddd3-6e85-4068-af44-76f2682629b4 0054-0255 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20121015 ANDA ANDA090351 Roxane Laboratories, Inc. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0054-0259_cb53b4e2-fbf4-43e0-a6d8-67a98f1c6003 0054-0259 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET ORAL 20120803 ANDA ANDA090655 Roxane Laboratories, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0054-0264_739702f0-d97b-4d21-8a70-158f9bfebd12 0054-0264 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride hydromorphone hydrochloride TABLET ORAL 20090729 ANDA ANDA074597 Roxane Laboratories, Inc HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0265_739702f0-d97b-4d21-8a70-158f9bfebd12 0054-0265 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride hydromorphone hydrochloride TABLET ORAL 20090729 ANDA ANDA074597 Roxane Laboratories, Inc HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0269_e0bc0144-d7b0-405f-909f-1ef3c982cbaa 0054-0269 HUMAN PRESCRIPTION DRUG Letrozole Letrozole TABLET ORAL 20110603 ANDA ANDA090838 Roxane Laboratories, Inc. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 0054-0273_34ec133d-d707-472e-886a-c298aab9f49c 0054-0273 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100419 ANDA ANDA091099 Roxane Laboratories, Inc IMIPRAMINE PAMOATE 75 mg/1 Tricyclic Antidepressant [EPC] 0054-0274_34ec133d-d707-472e-886a-c298aab9f49c 0054-0274 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100419 ANDA ANDA091099 Roxane Laboratories, Inc IMIPRAMINE PAMOATE 100 mg/1 Tricyclic Antidepressant [EPC] 0054-0275_34ec133d-d707-472e-886a-c298aab9f49c 0054-0275 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100419 ANDA ANDA091099 Roxane Laboratories, Inc IMIPRAMINE PAMOATE 125 mg/1 Tricyclic Antidepressant [EPC] 0054-0276_34ec133d-d707-472e-886a-c298aab9f49c 0054-0276 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100419 ANDA ANDA091099 Roxane Laboratories, Inc IMIPRAMINE PAMOATE 150 mg/1 Tricyclic Antidepressant [EPC] 0054-0277_48ce361f-a3e7-4b9a-9cc1-790019e2cea8 0054-0277 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20100406 ANDA ANDA077732 Roxane Laboratories, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0054-0278_98eeae65-0ca6-4c45-8554-02246907f6e9 0054-0278 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET ORAL 20100707 ANDA ANDA090381 Roxane Laboratories, Inc. NARATRIPTAN HYDROCHLORIDE 1 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0054-0279_98eeae65-0ca6-4c45-8554-02246907f6e9 0054-0279 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET ORAL 20100707 ANDA ANDA090381 Roxane Laboratories, Inc. NARATRIPTAN HYDROCHLORIDE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0054-0283_bdf41186-97f5-4512-8d4a-fb0f95ea1de3 0054-0283 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride oxymorphone hydrochloride TABLET ORAL 20100927 ANDA ANDA090964 Roxane Laboratories, Inc OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0284_bdf41186-97f5-4512-8d4a-fb0f95ea1de3 0054-0284 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride oxymorphone hydrochloride TABLET ORAL 20100927 ANDA ANDA090964 Roxane Laboratories, Inc OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0288_cb53b4e2-fbf4-43e0-a6d8-67a98f1c6003 0054-0288 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA091128 Roxane Laboratories, Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0054-0289_cb53b4e2-fbf4-43e0-a6d8-67a98f1c6003 0054-0289 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA091128 Roxane Laboratories, Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0054-0290_aafd8c09-69ee-4cc0-8e05-afa0314b3317 0054-0290 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20140415 ANDA ANDA091153 Roxane Laboratories, Inc. ESZOPICLONE 1 mg/1 CIV 0054-0291_aafd8c09-69ee-4cc0-8e05-afa0314b3317 0054-0291 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20140415 ANDA ANDA091153 Roxane Laboratories, Inc. ESZOPICLONE 2 mg/1 CIV 0054-0292_aafd8c09-69ee-4cc0-8e05-afa0314b3317 0054-0292 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20140415 ANDA ANDA091153 Roxane Laboratories, Inc. ESZOPICLONE 3 mg/1 CIV 0054-0293_0a1de051-166f-4b9e-9bdc-a9557b29770a 0054-0293 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride Azelastine Hydrochloride SPRAY, METERED NASAL 20141027 ANDA ANDA091444 Roxane Laboratories, Inc. AZELASTINE HYDROCHLORIDE 137 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0054-0334_1167360c-7e0f-4619-9d1a-ad4ee56cab71 0054-0334 HUMAN PRESCRIPTION DRUG Cevimeline Hydrochloride Cevimeline Hydrochloride CAPSULE ORAL 20130708 ANDA ANDA091591 Roxane Laboratories, Inc. CEVIMELINE HYDROCHLORIDE 30 mg/1 Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 0054-0338_1bb3ce2f-c77a-436f-980f-a02668f99fed 0054-0338 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol CAPSULE ORAL 20140218 ANDA ANDA091433 Roxane Laboratories, Inc. DOXERCALCIFEROL .5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] 0054-0339_1bb3ce2f-c77a-436f-980f-a02668f99fed 0054-0339 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol CAPSULE ORAL 20140218 ANDA ANDA091433 Roxane Laboratories, Inc. DOXERCALCIFEROL 2.5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] 0054-0347_4d5ea1c2-6126-432f-be61-44fb24d67b7e 0054-0347 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET, FILM COATED ORAL 20120430 ANDA ANDA201172 Roxane Laboratories, Inc TINIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0054-0348_4d5ea1c2-6126-432f-be61-44fb24d67b7e 0054-0348 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET, FILM COATED ORAL 20120430 ANDA ANDA201172 Roxane Laboratories, Inc TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0054-0356_719b12b2-061b-4893-b888-34191e45bc57 0054-0356 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20141104 ANDA ANDA202652 Roxane Laboratories, Inc DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] 0054-0357_719b12b2-061b-4893-b888-34191e45bc57 0054-0357 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20141104 ANDA ANDA202652 Roxane Laboratories, Inc DISULFIRAM 500 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] 0054-0379_6f91832b-2034-4dfb-afec-cdb291c74147 0054-0379 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate Sodium Polystyrene Sulfonate SUSPENSION ORAL; RECTAL 20130617 ANDA ANDA089049 Roxane Laboratories, Inc. SODIUM POLYSTYRENE SULFONATE 15 g/60mL 0054-0382_bd1316c9-f0e9-4e70-bef9-6bd57722d499 0054-0382 HUMAN PRESCRIPTION DRUG Cyclophosphamide Cyclophosphamide CAPSULE ORAL 20130916 NDA NDA203856 Roxane Laboratories, Inc. CYCLOPHOSPHAMIDE 25 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0054-0383_bd1316c9-f0e9-4e70-bef9-6bd57722d499 0054-0383 HUMAN PRESCRIPTION DRUG Cyclophosphamide Cyclophosphamide CAPSULE ORAL 20130916 NDA NDA203856 Roxane Laboratories, Inc. CYCLOPHOSPHAMIDE 50 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0054-0386_739702f0-d97b-4d21-8a70-158f9bfebd12 0054-0386 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride hydromorphone hydrochloride SOLUTION ORAL 20120301 ANDA ANDA074653 Roxane Laboratories, Inc HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0388_1bb3ce2f-c77a-436f-980f-a02668f99fed 0054-0388 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol CAPSULE ORAL 20140218 ANDA ANDA091433 Roxane Laboratories, Inc. DOXERCALCIFEROL 1 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] 0054-0391_be690f1f-2534-4c85-b62b-a9f3e7fea972 0054-0391 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride CONCENTRATE ORAL 19880430 ANDA ANDA089897 Roxane Laboratories, Inc METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0392_be690f1f-2534-4c85-b62b-a9f3e7fea972 0054-0392 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride CONCENTRATE ORAL 19880430 ANDA ANDA040180 Roxane Laboratories, Inc METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0404_81d14a02-5271-4090-990e-74effd5ec392 0054-0404 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20110125 NDA NDA022195 Roxane Laboratories, Inc MORPHINE SULFATE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0434_ae7585ec-1280-40fe-b888-613b8a0e6ef6 0054-0434 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET ORAL 20120215 NDA AUTHORIZED GENERIC NDA012836 Roxane Laboratories, Inc. DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0054-0435_ae7585ec-1280-40fe-b888-613b8a0e6ef6 0054-0435 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET ORAL 20120215 NDA AUTHORIZED GENERIC NDA012836 Roxane Laboratories, Inc. DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0054-0436_ae7585ec-1280-40fe-b888-613b8a0e6ef6 0054-0436 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET ORAL 20120215 NDA AUTHORIZED GENERIC NDA012836 Roxane Laboratories, Inc. DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0054-0438_86fde2f6-35d0-4d7f-b6b8-724fdcc3fc6c 0054-0438 HUMAN PRESCRIPTION DRUG LEVORPHANOL TARTRATE LEVORPHANOL TARTRATE TABLET ORAL 20000331 ANDA ANDA074278 Roxane Laboratories, Inc LEVORPHANOL TARTRATE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0450_645607af-3ef3-4765-bbff-ba9c483be141 0054-0450 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine SUSPENSION ORAL 20120521 NDA AUTHORIZED GENERIC NDA020933 Roxane Laboratories, Inc. NEVIRAPINE 50 mg/5mL Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 0054-0459_645607af-3ef3-4765-bbff-ba9c483be141 0054-0459 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET ORAL 20120521 NDA AUTHORIZED GENERIC NDA020636 Roxane Laboratories, Inc. NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 0054-0522_42b60d78-0239-47eb-8a2b-1f8c8b5e2fe7 0054-0522 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20130716 ANDA ANDA203208 Roxane Laboratories, Inc. OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0523_72260dc5-08eb-4b91-ae54-c7be35242b70 0054-0523 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride SOLUTION ORAL 20130715 ANDA ANDA204037 Roxane Laboratories, Inc. OXYCODONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-0542_3181d225-4ceb-4071-bf45-7a8bd734b60f 0054-0542 HUMAN PRESCRIPTION DRUG Telmisartan telmisartan TABLET ORAL 20140108 NDA AUTHORIZED GENERIC NDA020850 Roxane Laboratories, Inc. TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0054-0543_3181d225-4ceb-4071-bf45-7a8bd734b60f 0054-0543 HUMAN PRESCRIPTION DRUG Telmisartan telmisartan TABLET ORAL 20140108 NDA AUTHORIZED GENERIC NDA020850 Roxane Laboratories, Inc. TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0054-0544_3181d225-4ceb-4071-bf45-7a8bd734b60f 0054-0544 HUMAN PRESCRIPTION DRUG Telmisartan telmisartan TABLET ORAL 20140108 NDA AUTHORIZED GENERIC NDA020850 Roxane Laboratories, Inc. TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0054-0545_7be16898-c8ee-43df-a013-edc01c3c96a2 0054-0545 HUMAN PRESCRIPTION DRUG telmisartan and hydrochlorothiazide telmisartan and hydrochlorothiazide TABLET ORAL 20140228 NDA AUTHORIZED GENERIC NDA021162 Roxane Laboratories, Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0054-0546_7be16898-c8ee-43df-a013-edc01c3c96a2 0054-0546 HUMAN PRESCRIPTION DRUG telmisartan and hydrochlorothiazide telmisartan and hydrochlorothiazide TABLET ORAL 20140228 NDA AUTHORIZED GENERIC NDA021162 Roxane Laboratories, Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0054-0547_7be16898-c8ee-43df-a013-edc01c3c96a2 0054-0547 HUMAN PRESCRIPTION DRUG telmisartan and hydrochlorothiazide telmisartan and hydrochlorothiazide TABLET ORAL 20140228 NDA AUTHORIZED GENERIC NDA021162 Roxane Laboratories, Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 25; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0054-0551_2cdfb509-e962-439a-9c0f-d91568b4a905 0054-0551 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 19910201 ANDA ANDA087003 Roxane Laboratories, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-2526_9e91dceb-800c-41af-ab37-f9e8ecb30386 0054-2526 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19870128 NDA NDA017812 Roxane Laboratories, Inc LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] 0054-2527_9e91dceb-800c-41af-ab37-f9e8ecb30386 0054-2527 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19801126 NDA NDA017812 Roxane Laboratories, Inc LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 0054-2531_9e91dceb-800c-41af-ab37-f9e8ecb30386 0054-2531 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19870128 NDA NDA017812 Roxane Laboratories, Inc LITHIUM CARBONATE 600 mg/1 Mood Stabilizer [EPC] 0054-2795_1b0fb66f-9614-4d30-9c08-cf117266e552 0054-2795 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride and Acetaminophen Oxycodone Hydrochloride and Acetaminophen CAPSULE ORAL 19950703 ANDA ANDA040061 Roxane Laboratories, Inc ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-3025_75406bd9-25e8-4696-8cd7-20fef714d887 0054-3025 HUMAN PRESCRIPTION DRUG Acetylcysteine Acetylcysteine SOLUTION ORAL; RESPIRATORY (INHALATION) 19960501 ANDA ANDA072323 Roxane Laboratories, Inc. ACETYLCYSTEINE 100 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 0054-3026_75406bd9-25e8-4696-8cd7-20fef714d887 0054-3026 HUMAN PRESCRIPTION DRUG Acetylcysteine Acetylcysteine SOLUTION ORAL; RESPIRATORY (INHALATION) 19960501 ANDA ANDA072324 Roxane Laboratories, Inc. ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 0054-3027_75406bd9-25e8-4696-8cd7-20fef714d887 0054-3027 HUMAN PRESCRIPTION DRUG Acetylcysteine Acetylcysteine SOLUTION ORAL; RESPIRATORY (INHALATION) 19960501 ANDA ANDA072323 Roxane Laboratories, Inc. ACETYLCYSTEINE 100 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 0054-3028_75406bd9-25e8-4696-8cd7-20fef714d887 0054-3028 HUMAN PRESCRIPTION DRUG Acetylcysteine Acetylcysteine SOLUTION ORAL; RESPIRATORY (INHALATION) 19960501 ANDA ANDA072324 Roxane Laboratories, Inc. ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 0054-3068_36332579-ec2e-44a4-8c4c-3d8d62b8a769 0054-3068 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam SOLUTION, CONCENTRATE ORAL 19931031 ANDA ANDA074312 Roxane Laboratories, Inc ALPRAZOLAM 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0054-3090_0bb84f88-a162-40df-860c-09968535c9f5 0054-3090 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate Butorphanol Tartrate SPRAY, METERED NASAL 20020312 ANDA ANDA075824 Roxane Laboratories, Inc BUTORPHANOL TARTRATE 10 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV 0054-3117_66a5d7e7-c57b-4621-802f-1096c6214576 0054-3117 HUMAN OTC DRUG Calcium Carbonate Calcium Carbonate SUSPENSION ORAL 20091124 OTC MONOGRAPH FINAL part331 Roxane Laboratories, Inc. CALCIUM CARBONATE 1250 mg/5mL 0054-3120_18655b58-5dd4-42b9-9a89-1821d9539bc0 0054-3120 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol SOLUTION ORAL 20030718 ANDA ANDA076242 Roxane Laboratories, Inc CALCITRIOL 1 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0054-3176_b15200fb-1826-472b-a907-e677a272513b 0054-3176 HUMAN PRESCRIPTION DRUG Dexamethasone Intensol Dexamethasone Intensol SOLUTION, CONCENTRATE ORAL 19830901 ANDA ANDA088252 Roxane Laboratories, Inc DEXAMETHASONE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-3177_b15200fb-1826-472b-a907-e677a272513b 0054-3177 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone SOLUTION ORAL 20071101 ANDA ANDA088248 Roxane Laboratories, Inc DEXAMETHASONE .5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-3185_962d8ac0-a959-4a96-8a30-a3b317890d97 0054-3185 HUMAN PRESCRIPTION DRUG Diazepam Intensol Diazepam Intensol SOLUTION, CONCENTRATE ORAL 19870403 ANDA ANDA071415 Roxane Laboratories, Inc DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0054-3188_962d8ac0-a959-4a96-8a30-a3b317890d97 0054-3188 HUMAN PRESCRIPTION DRUG Diazepam Diazepam SOLUTION ORAL 19870403 ANDA ANDA070928 Roxane Laboratories, Inc DIAZEPAM 5 mg/5mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0054-3194_06034f54-49c8-41ef-84c4-1c538a18ec2c 0054-3194 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate SOLUTION ORAL 19820503 ANDA ANDA087708 Roxane Laboratories, Inc ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Antidiarrheal [EPC] CV 0054-3270_331a591a-2e19-4a15-8f25-a9cf198a1ce3 0054-3270 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20060222 ANDA ANDA076504 Roxane Laboratories, Inc FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-3294_37a8d24e-44c9-4f93-8e3d-d7f0d5ae3fff 0054-3294 HUMAN PRESCRIPTION DRUG Furosemide Furosemide SOLUTION ORAL 19880712 ANDA ANDA070434 Roxane Laboratories, Inc FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0054-3298_37a8d24e-44c9-4f93-8e3d-d7f0d5ae3fff 0054-3298 HUMAN PRESCRIPTION DRUG Furosemide Furosemide SOLUTION ORAL 19870422 ANDA ANDA070433 Roxane Laboratories, Inc FUROSEMIDE 40 mg/5mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0054-3486_2fe38f65-1206-4dd9-8256-6cba1f955855 0054-3486 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL 19920529 ANDA ANDA073591 Roxane Laboratories, Inc LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 0054-3500_e06bfca3-68a6-4401-bde1-25eded30c3bf 0054-3500 HUMAN PRESCRIPTION DRUG Lidocaine Viscous Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19850426 ANDA ANDA088802 Roxane Laboratories,Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0054-3505_a2c3e4a0-e5f7-4b1a-99f1-3d4de7075b0b 0054-3505 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION TOPICAL 19850403 ANDA ANDA088803 Roxane Laboratories,Inc. LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0054-3527_9e91dceb-800c-41af-ab37-f9e8ecb30386 0054-3527 HUMAN PRESCRIPTION DRUG Lithium Lithium SOLUTION ORAL 19820429 NDA NDA018421 Roxane Laboratories, Inc LITHIUM CITRATE 8 meq/5mL Mood Stabilizer [EPC] 0054-3532_107e39a2-bcfa-457f-bedf-b465918e92d4 0054-3532 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam SOLUTION, CONCENTRATE ORAL 19910628 ANDA ANDA073079 Roxane Laboratories, Inc LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0054-3542_1996ecaa-9f50-4bc8-88e5-aad797eafb61 0054-3542 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20020215 ANDA ANDA075997 Roxane Laboratories, Inc MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0054-3545_74376865-f251-4e4a-91d2-02b632d03836 0054-3545 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride SOLUTION ORAL 19850130 ANDA ANDA088744 Roxane Laboratories, Inc MEPERIDINE HYDROCHLORIDE 50 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-3553_fb4b9557-67da-44fa-a714-d44f8f38b8ff 0054-3553 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride CONCENTRATE ORAL 19880906 ANDA ANDA089897 Roxane Laboratories, Inc METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-3555_8124c319-ec50-4fff-9cbf-abda52a854c6 0054-3555 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride SOLUTION ORAL 19810522 ANDA ANDA087393 Roxane Laboratories, Inc. METHADONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-3556_8124c319-ec50-4fff-9cbf-abda52a854c6 0054-3556 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride SOLUTION ORAL 19820830 ANDA ANDA087997 Roxane Laboratories, Inc. METHADONE HYDROCHLORIDE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-3566_de03416b-cc43-4bb3-9fff-da39f413d4f8 0054-3566 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride SYRUP ORAL 20020430 ANDA ANDA075873 Roxane Laboratories, Inc MIDAZOLAM HYDROCHLORIDE 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0054-3567_d94ebb8a-2576-4fb5-8712-584166f88949 0054-3567 HUMAN OTC DRUG Milk of Magnesia Milk of Magnesia CONCENTRATE ORAL 20010312 OTC MONOGRAPH NOT FINAL part334 Roxane Laboratories, Inc. MAGNESIUM HYDROXIDE 2400 mg/10mL 0054-3686_4edd4ea0-ca1e-4a3a-8786-71d29d46fe62 0054-3686 HUMAN PRESCRIPTION DRUG Roxicet Oxycodone and Acetaminophen SOLUTION ORAL 19861203 ANDA ANDA089351 Roxane Laboratories, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-3721_645709c0-48d1-444f-8d51-f38b7109ecf3 0054-3721 HUMAN PRESCRIPTION DRUG PredniSONE Intensol PredniSONE Intensol SOLUTION, CONCENTRATE ORAL 19850220 ANDA ANDA088810 Roxane Laboratories, Inc. PREDNISONE 5 mg/mL 0054-3722_645709c0-48d1-444f-8d51-f38b7109ecf3 0054-3722 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE SOLUTION ORAL 19861213 ANDA ANDA088703 Roxane Laboratories, Inc. PREDNISONE 5 mg/mL 0054-3727_79f8cbf5-fd1b-4c0b-bbd0-8dbc7b626dd9 0054-3727 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride SOLUTION ORAL 19870515 ANDA ANDA070979 Roxane Laboratories, Inc PROPRANOLOL HYDROCHLORIDE 20 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0054-3730_79f8cbf5-fd1b-4c0b-bbd0-8dbc7b626dd9 0054-3730 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride SOLUTION ORAL 19870515 ANDA ANDA070690 Roxane Laboratories, Inc PROPRANOLOL HYDROCHLORIDE 40 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0054-4084_3e0b2618-5bcc-4c58-adc8-00038bf74bf3 0054-4084 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 19960216 ANDA ANDA074069 Roxane Laboratories, Inc AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 0054-4120_c7165c57-f550-4c9d-9055-1ccf8282c639 0054-4120 HUMAN OTC DRUG Calcium Carbonate Calcium Carbonate TABLET ORAL 20041118 OTC MONOGRAPH FINAL part331 Roxane Laboratories, Inc. CALCIUM CARBONATE 1250 mg/1 0054-4129_da1a5cfb-b6b0-4cd0-a002-1425ae11a7a7 0054-4129 HUMAN PRESCRIPTION DRUG Cyclophosphamide Cyclophosphamide TABLET ORAL 19990817 ANDA ANDA040032 Roxane Laboratories, Inc CYCLOPHOSPHAMIDE 25 mg/1 0054-4130_da1a5cfb-b6b0-4cd0-a002-1425ae11a7a7 0054-4130 HUMAN PRESCRIPTION DRUG Cyclophosphamide Cyclophosphamide TABLET ORAL 19990817 ANDA ANDA040032 Roxane Laboratories, Inc CYCLOPHOSPHAMIDE 50 mg/1 0054-4146_88c6d4ab-df0d-4638-85c7-331414d01947 0054-4146 HUMAN PRESCRIPTION DRUG Clotrimazole Clotrimazole LOZENGE ORAL; TOPICAL 20040729 ANDA ANDA076387 Roxane Laboratories, Inc CLOTRIMAZOLE 10 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0054-4179_b15200fb-1826-472b-a907-e677a272513b 0054-4179 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750725 ANDA ANDA084611 Roxane Laboratories, Inc DEXAMETHASONE .5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-4180_b15200fb-1826-472b-a907-e677a272513b 0054-4180 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750603 ANDA ANDA084613 Roxane Laboratories, Inc DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-4181_b15200fb-1826-472b-a907-e677a272513b 0054-4181 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19830915 ANDA ANDA088306 Roxane Laboratories, Inc DEXAMETHASONE 1 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-4182_b15200fb-1826-472b-a907-e677a272513b 0054-4182 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20060707 ANDA ANDA084610 Roxane Laboratories, Inc DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-4183_b15200fb-1826-472b-a907-e677a272513b 0054-4183 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19820826 ANDA ANDA087916 Roxane Laboratories, Inc DEXAMETHASONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-4184_b15200fb-1826-472b-a907-e677a272513b 0054-4184 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 Roxane Laboratories, Inc DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-4186_b15200fb-1826-472b-a907-e677a272513b 0054-4186 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19830915 ANDA ANDA088316 Roxane Laboratories, Inc DEXAMETHASONE 6 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-4218_b7a85ddb-5975-47fc-a9ef-f723dacae96a 0054-4218 HUMAN PRESCRIPTION DRUG DOLOPHINE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 Roxane Laboratories, Inc METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-4219_b7a85ddb-5975-47fc-a9ef-f723dacae96a 0054-4219 HUMAN PRESCRIPTION DRUG DOLOPHINE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 Roxane Laboratories, Inc METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-4297_37a8d24e-44c9-4f93-8e3d-d7f0d5ae3fff 0054-4297 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 Roxane Laboratories, Inc FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0054-4299_37a8d24e-44c9-4f93-8e3d-d7f0d5ae3fff 0054-4299 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 Roxane Laboratories, Inc FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0054-4301_37a8d24e-44c9-4f93-8e3d-d7f0d5ae3fff 0054-4301 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19910313 ANDA ANDA070086 Roxane Laboratories, Inc FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0054-4496_8bd4163e-0c69-4c76-bff1-5225e73fe16d 0054-4496 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19930222 ANDA ANDA072733 Roxane Laboratories, Inc. LEUCOVORIN CALCIUM 5 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 0054-4497_8bd4163e-0c69-4c76-bff1-5225e73fe16d 0054-4497 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19930222 ANDA ANDA072734 Roxane Laboratories, Inc. LEUCOVORIN CALCIUM 10 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 0054-4498_8bd4163e-0c69-4c76-bff1-5225e73fe16d 0054-4498 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19930222 ANDA ANDA072735 Roxane Laboratories, Inc. LEUCOVORIN CALCIUM 15 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 0054-4499_8bd4163e-0c69-4c76-bff1-5225e73fe16d 0054-4499 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19930222 ANDA ANDA072736 Roxane Laboratories, Inc. LEUCOVORIN CALCIUM 25 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 0054-4527_9e91dceb-800c-41af-ab37-f9e8ecb30386 0054-4527 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET ORAL 19820129 NDA NDA018558 Roxane Laboratories, Inc LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 0054-4538_590eb00c-f20a-4704-b748-d530ed4013f0 0054-4538 HUMAN PRESCRIPTION DRUG DISKETS Methadone Hydrochloride TABLET ORAL 19730314 NDA NDA017058 Roxane Laboratories, Inc METHADONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-4550_46e54fca-77b9-465b-9da6-f5be1d88d356 0054-4550 HUMAN PRESCRIPTION DRUG Methotrexate Sodium Methotrexate Sodium TABLET ORAL 19940801 ANDA ANDA040054 Roxane Laboratories, Inc METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0054-4570_f59ac417-c75d-4245-beab-19ffc52923b8 0054-4570 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 Roxane Laboratories, Inc METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-4571_f59ac417-c75d-4245-beab-19ffc52923b8 0054-4571 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 Roxane Laboratories, Inc METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-4581_0f8495c5-dce6-459e-b319-f13eca423087 0054-4581 HUMAN PRESCRIPTION DRUG Mercaptopurine Mercaptopurine TABLET ORAL 20040213 ANDA ANDA040528 Roxane Laboratories, Inc MERCAPTOPURINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0054-4595_74376865-f251-4e4a-91d2-02b632d03836 0054-4595 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 19970312 ANDA ANDA040110 Roxane Laboratories, Inc MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-4596_74376865-f251-4e4a-91d2-02b632d03836 0054-4596 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 19970312 ANDA ANDA040110 Roxane Laboratories, Inc MEPERIDINE HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-4603_7bdb1eb9-df94-4a69-b6c0-2ec3d58c2b09 0054-4603 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19950929 ANDA ANDA074458 Roxane Laboratories, Inc MEGESTROL ACETATE 20 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0054-4604_7bdb1eb9-df94-4a69-b6c0-2ec3d58c2b09 0054-4604 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19950929 ANDA ANDA074458 Roxane Laboratories, Inc MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0054-4650_4edd4ea0-ca1e-4a3a-8786-71d29d46fe62 0054-4650 HUMAN PRESCRIPTION DRUG Roxicet Oxycodone and Acetaminophen TABLET ORAL 19910201 ANDA ANDA087003 Roxane Laboratories, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-4721_3887c838-ce02-49dd-b7e2-b352e8f9e258 0054-4721 HUMAN PRESCRIPTION DRUG Propantheline Bromide Propantheline Bromide TABLET, FILM COATED ORAL 19811214 ANDA ANDA080927 Roxane Laboratories, Inc. PROPANTHELINE BROMIDE 15 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0054-4728_645709c0-48d1-444f-8d51-f38b7109ecf3 0054-4728 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 Roxane Laboratories, Inc. PREDNISONE 5 mg/1 0054-4741_645709c0-48d1-444f-8d51-f38b7109ecf3 0054-4741 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087800 Roxane Laboratories, Inc. PREDNISONE 1 mg/1 0054-4742_645709c0-48d1-444f-8d51-f38b7109ecf3 0054-4742 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087801 Roxane Laboratories, Inc. PREDNISONE 2.5 mg/1 0054-4784_bdebf90a-74f9-44fa-b37e-3ea41d9caba9 0054-4784 HUMAN PRESCRIPTION DRUG Roxicet Oxycodone and Acetaminophen TABLET ORAL 19890112 ANDA ANDA089775 Roxane Laboratories, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-4858_a019aa8d-3e29-496a-a01a-1910707956e2 0054-4858 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 20090713 ANDA ANDA074224 Roxane Laboratories, Inc. TRIAZOLAM .125 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0054-8084_3e0b2618-5bcc-4c58-adc8-00038bf74bf3 0054-8084 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 19960216 ANDA ANDA074069 Roxane Laboratories, Inc AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 0054-8120_c7165c57-f550-4c9d-9055-1ccf8282c639 0054-8120 HUMAN OTC DRUG Calcium Carbonate Calcium Carbonate TABLET ORAL 20041118 OTC MONOGRAPH FINAL part331 Roxane Laboratories, Inc. CALCIUM CARBONATE 1250 mg/1 0054-8146_88c6d4ab-df0d-4638-85c7-331414d01947 0054-8146 HUMAN PRESCRIPTION DRUG Clotrimazole Clotrimazole LOZENGE ORAL; TOPICAL 20040729 ANDA ANDA076387 Roxane Laboratories, Inc CLOTRIMAZOLE 10 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0054-8174_b15200fb-1826-472b-a907-e677a272513b 0054-8174 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19830915 ANDA ANDA088306 Roxane Laboratories, Inc DEXAMETHASONE 1 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-8175_b15200fb-1826-472b-a907-e677a272513b 0054-8175 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 Roxane Laboratories, Inc DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-8176_b15200fb-1826-472b-a907-e677a272513b 0054-8176 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19820826 ANDA ANDA087916 Roxane Laboratories, Inc DEXAMETHASONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-8179_b15200fb-1826-472b-a907-e677a272513b 0054-8179 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750725 ANDA ANDA084611 Roxane Laboratories, Inc DEXAMETHASONE .5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-8180_b15200fb-1826-472b-a907-e677a272513b 0054-8180 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750603 ANDA ANDA084613 Roxane Laboratories, Inc DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-8181_b15200fb-1826-472b-a907-e677a272513b 0054-8181 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20060707 ANDA ANDA084610 Roxane Laboratories, Inc DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-8183_b15200fb-1826-472b-a907-e677a272513b 0054-8183 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19830915 ANDA ANDA088316 Roxane Laboratories, Inc DEXAMETHASONE 6 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0054-8207_962d8ac0-a959-4a96-8a30-a3b317890d97 0054-8207 HUMAN PRESCRIPTION DRUG Diazepam Diazepam SOLUTION ORAL 19900614 ANDA ANDA070928 Roxane Laboratories, Inc DIAZEPAM 5 mg/5mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0054-8297_37a8d24e-44c9-4f93-8e3d-d7f0d5ae3fff 0054-8297 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 Roxane Laboratories, Inc FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0054-8298_37a8d24e-44c9-4f93-8e3d-d7f0d5ae3fff 0054-8298 HUMAN PRESCRIPTION DRUG Furosemide Furosemide SOLUTION ORAL 19870422 ANDA ANDA070433 Roxane Laboratories, Inc FUROSEMIDE 40 mg/5mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0054-8299_37a8d24e-44c9-4f93-8e3d-d7f0d5ae3fff 0054-8299 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 Roxane Laboratories, Inc FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0054-8301_37a8d24e-44c9-4f93-8e3d-d7f0d5ae3fff 0054-8301 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19860124 ANDA ANDA070086 Roxane Laboratories, Inc FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0054-8486_2fe38f65-1206-4dd9-8256-6cba1f955855 0054-8486 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL 19920529 ANDA ANDA073591 Roxane Laboratories, Inc LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 0054-8496_8bd4163e-0c69-4c76-bff1-5225e73fe16d 0054-8496 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19930222 ANDA ANDA072733 Roxane Laboratories, Inc. LEUCOVORIN CALCIUM 5 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 0054-8500_e06bfca3-68a6-4401-bde1-25eded30c3bf 0054-8500 HUMAN PRESCRIPTION DRUG Lidocaine Viscous Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19850426 ANDA ANDA088802 Roxane Laboratories,Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0054-8526_9e91dceb-800c-41af-ab37-f9e8ecb30386 0054-8526 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19870128 NDA NDA017812 Roxane Laboratories, Inc LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] 0054-8527_9e91dceb-800c-41af-ab37-f9e8ecb30386 0054-8527 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19870728 NDA NDA017812 Roxane Laboratories, Inc LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 0054-8528_9e91dceb-800c-41af-ab37-f9e8ecb30386 0054-8528 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET ORAL 19820614 NDA NDA018558 Roxane Laboratories, Inc LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 0054-8529_9e91dceb-800c-41af-ab37-f9e8ecb30386 0054-8529 HUMAN PRESCRIPTION DRUG Lithium Lithium SOLUTION ORAL 19820429 NDA NDA018421 Roxane Laboratories, Inc LITHIUM CITRATE 8 meq/5mL Mood Stabilizer [EPC] 0054-8531_9e91dceb-800c-41af-ab37-f9e8ecb30386 0054-8531 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19870128 NDA NDA017812 Roxane Laboratories, Inc LITHIUM CARBONATE 600 mg/1 Mood Stabilizer [EPC] 0054-8550_46e54fca-77b9-465b-9da6-f5be1d88d356 0054-8550 HUMAN PRESCRIPTION DRUG Methotrexate Sodium Methotrexate Sodium TABLET ORAL 19940801 ANDA ANDA040054 Roxane Laboratories, Inc METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0054-8553_f59ac417-c75d-4245-beab-19ffc52923b8 0054-8553 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 Roxane Laboratories, Inc METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-8554_f59ac417-c75d-4245-beab-19ffc52923b8 0054-8554 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 Roxane Laboratories, Inc METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-8595_74376865-f251-4e4a-91d2-02b632d03836 0054-8595 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 19970312 ANDA ANDA040110 Roxane Laboratories, Inc MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-8603_7bdb1eb9-df94-4a69-b6c0-2ec3d58c2b09 0054-8603 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19950929 ANDA ANDA074458 Roxane Laboratories, Inc MEGESTROL ACETATE 20 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0054-8604_7bdb1eb9-df94-4a69-b6c0-2ec3d58c2b09 0054-8604 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19950929 ANDA ANDA074458 Roxane Laboratories, Inc MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0054-8648_4edd4ea0-ca1e-4a3a-8786-71d29d46fe62 0054-8648 HUMAN PRESCRIPTION DRUG Roxicet Oxycodone and Acetaminophen SOLUTION ORAL 19910117 20160702 ANDA ANDA089351 Roxane Laboratories, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-8650_4edd4ea0-ca1e-4a3a-8786-71d29d46fe62 0054-8650 HUMAN PRESCRIPTION DRUG Roxicet Oxycodone and Acetaminophen TABLET ORAL 19870311 ANDA ANDA087003 Roxane Laboratories, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0054-8722_645709c0-48d1-444f-8d51-f38b7109ecf3 0054-8722 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE SOLUTION ORAL 19841108 20160909 ANDA ANDA088703 Roxane Laboratories, Inc. PREDNISONE 5 mg/mL 0054-8724_645709c0-48d1-444f-8d51-f38b7109ecf3 0054-8724 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 Roxane Laboratories, Inc. PREDNISONE 5 mg/1 0054-8739_645709c0-48d1-444f-8d51-f38b7109ecf3 0054-8739 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087800 Roxane Laboratories, Inc. PREDNISONE 1 mg/1 0054-8740_645709c0-48d1-444f-8d51-f38b7109ecf3 0054-8740 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087801 Roxane Laboratories, Inc. PREDNISONE 2.5 mg/1 0054-8858_a019aa8d-3e29-496a-a01a-1910707956e2 0054-8858 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 19940601 ANDA ANDA074224 Roxane Laboratories, Inc. TRIAZOLAM .125 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0054-8859_a019aa8d-3e29-496a-a01a-1910707956e2 0054-8859 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 19940601 20160130 ANDA ANDA074224 Roxane Laboratories, Inc. TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0056-0168_c7381986-586c-4a51-9001-739f0d24b65c 0056-0168 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0056-0169_c7381986-586c-4a51-9001-739f0d24b65c 0056-0169 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0056-0170_c7381986-586c-4a51-9001-739f0d24b65c 0056-0170 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0056-0172_c7381986-586c-4a51-9001-739f0d24b65c 0056-0172 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0056-0173_c7381986-586c-4a51-9001-739f0d24b65c 0056-0173 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0056-0174_c7381986-586c-4a51-9001-739f0d24b65c 0056-0174 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0056-0176_c7381986-586c-4a51-9001-739f0d24b65c 0056-0176 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0056-0188_c7381986-586c-4a51-9001-739f0d24b65c 0056-0188 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0056-0189_c7381986-586c-4a51-9001-739f0d24b65c 0056-0189 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0056-0470_b4cf9419-4f35-475e-bb90-1c0f6053d850 0056-0470 HUMAN PRESCRIPTION DRUG SUSTIVA Efavirenz CAPSULE, GELATIN COATED ORAL 19980917 NDA NDA020972 Bristol-Myers Squibb Pharma Company EFAVIRENZ 50 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] 0056-0474_b4cf9419-4f35-475e-bb90-1c0f6053d850 0056-0474 HUMAN PRESCRIPTION DRUG SUSTIVA efavirenz CAPSULE, GELATIN COATED ORAL 19980917 NDA NDA020972 Bristol-Myers Squibb Pharma Company EFAVIRENZ 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] 0056-0510_b4cf9419-4f35-475e-bb90-1c0f6053d850 0056-0510 HUMAN PRESCRIPTION DRUG SUSTIVA efavirenz TABLET, FILM COATED ORAL 20020102 NDA NDA021360 Bristol-Myers Squibb Pharma Company EFAVIRENZ 600 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] 0062-0165_cd5837f0-e610-11e1-857a-df256288709b 0062-0165 HUMAN PRESCRIPTION DRUG Retin-A Tretinoin CREAM TOPICAL 19881030 NDA NDA019049 Ortho-McNeil Janssen Pharmaceuticals, Inc. TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0062-0175_cd5837f0-e610-11e1-857a-df256288709b 0062-0175 HUMAN PRESCRIPTION DRUG Retin-A Tretinoin CREAM TOPICAL 19740730 NDA NDA017522 Ortho-McNeil Janssen Pharmaceuticals, Inc. TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0062-0187_c11f06e2-891e-4cf4-8c03-2249a943219a 0062-0187 HUMAN PRESCRIPTION DRUG Renova Tretinoin CREAM TOPICAL 20111018 20151031 NDA NDA021108 Ortho-McNeil Janssen Pharmaceuticals, Inc. TRETINOIN .2 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0062-0190_3b7f070c-5790-4243-9ce7-cc41509ea947 0062-0190 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 20110501 NDA NDA020475 Ortho-McNeil Pharmaceuticals TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0062-0204_3b7f070c-5790-4243-9ce7-cc41509ea947 0062-0204 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 20110501 NDA NDA020475 Ortho-McNeil Pharmaceuticals TRETINOIN .4 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0062-0275_cd5837f0-e610-11e1-857a-df256288709b 0062-0275 HUMAN PRESCRIPTION DRUG Retin-A Tretinoin CREAM TOPICAL 19730430 NDA NDA017340 Ortho-McNeil Janssen Pharmaceuticals, Inc. TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0062-0475_cd5837f0-e610-11e1-857a-df256288709b 0062-0475 HUMAN PRESCRIPTION DRUG Retin-A Tretinoin GEL TOPICAL 19750730 NDA NDA017579 Ortho-McNeil Janssen Pharmaceuticals, Inc. TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0062-0575_cd5837f0-e610-11e1-857a-df256288709b 0062-0575 HUMAN PRESCRIPTION DRUG Retin-A Tretinoin GEL TOPICAL 19790730 NDA NDA017955 Ortho-McNeil Janssen Pharmaceuticals, Inc. TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0062-5350_c884b618-0de0-11e0-98a8-3a04dfd72085 0062-5350 HUMAN PRESCRIPTION DRUG Terazol 7 TERCONAZOLE CREAM VAGINAL 19880627 NDA NDA019579 Ortho-McNeil-Janssen Pharmaceutical TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0062-5351_c884b618-0de0-11e0-98a8-3a04dfd72085 0062-5351 HUMAN PRESCRIPTION DRUG Terazol 3 TERCONAZOLE SUPPOSITORY VAGINAL 19880627 NDA NDA019641 Ortho-McNeil-Janssen Pharmaceutical TERCONAZOLE 80 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0062-5356_c884b618-0de0-11e0-98a8-3a04dfd72085 0062-5356 HUMAN PRESCRIPTION DRUG Terazol 3 TERCONAZOLE CREAM VAGINAL 19910221 NDA NDA019964 Ortho-McNeil-Janssen Pharmaceutical TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0064-0300_d26473d3-3e16-4927-b3f1-c86821eb6d0c 0064-0300 HUMAN OTC DRUG PROSHIELD PLUS SKIN PROTECTANT DIMETHICONE OINTMENT TOPICAL 19970101 OTC MONOGRAPH FINAL part347 HEALTHPOINT, LTD DIMETHICONE .01 g/g 0064-0810_c080f728-52c4-4c59-a2b5-4959f144ccb0 0064-0810 HUMAN PRESCRIPTION DRUG REGRANEX becaplermin GEL TOPICAL 20111101 BLA BLA103691 HEALTHPOINT, LTD BECAPLERMIN 100 ug/g Human Platelet-derived Growth Factor [EPC],Platelet-Derived Growth Factor [Chemical/Ingredient] 0064-0850_f63dff0e-678c-46b0-a506-0d10c2ddd594 0064-0850 HUMAN OTC DRUG PROSHIELD GLOVE SKIN PROTECTANT DIMETHICONE CREAM TOPICAL 20070101 OTC MONOGRAPH FINAL part347 HEALTHPOINT, LTD DIMETHICONE .01 g/g 0064-1011_2c0306c4-5016-4b57-bfcc-15d54dd07bb4 0064-1011 HUMAN OTC DRUG ACTIPREP PREOPERATIVE SKIN PREPARATION ETHYL ALCOHOL LOTION TOPICAL 20011001 OTC MONOGRAPH NOT FINAL part333E HEALTHPOINT, LTD ALCOHOL .79 mL/mL 0064-1030_65dd8689-6a41-4ae2-8742-8828cdc715f8 0064-1030 HUMAN OTC DRUG TRISEPTIN WATER AIDED ALCOHOL LOTION TOPICAL 20000501 OTC MONOGRAPH NOT FINAL part333E HEALTHPOINT, LTD ALCOHOL .7 mL/mL 0064-1040_b83ce388-332a-42bc-ab5a-13442711c86b 0064-1040 HUMAN OTC DRUG TRISEPTIN WATERLESS ETHYL ALCOHOL SOLUTION TOPICAL 20040301 OTC MONOGRAPH NOT FINAL part333E HEALTHPOINT, LTD ALCOHOL .61 g/g 0064-1050_39ef369b-8e81-442a-9e31-55ee8b2585bf 0064-1050 HUMAN OTC DRUG TRISEPTIN HAND AND BODY ANTISEPTIC ALCOHOL LOTION TOPICAL 20020401 OTC MONOGRAPH NOT FINAL part333E HEALTHPOINT, LTD ALCOHOL .7 mL/mL 0064-1080_52f6b789-93c1-4c90-8c1d-3d1cf8fb664b 0064-1080 HUMAN OTC DRUG SURGICEPT Waterless, Surgical Handscrub and Healthcare Personnel Handwash ethyl alcohol SOLUTION TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333E HEALTHPOINT, LTD ALCOHOL .75 mL/mL 0064-3600_3b1e2e6a-4d54-4687-af79-042a4932c5e1 0064-3600 HUMAN PRESCRIPTION DRUG PRUDOXIN doxepin hydrochloride CREAM TOPICAL 20011001 NDA NDA020126 HEALTHPOINT, LTD DOXEPIN HYDROCHLORIDE 50 mg/g Tricyclic Antidepressant [EPC] 0064-3900_abd6a939-8282-4e26-89b9-b0920f3f39f7 0064-3900 HUMAN PRESCRIPTION DRUG XENADERM Balsam Peru, Castor Oil and Trypsin OINTMENT TOPICAL 20020301 UNAPPROVED DRUG OTHER HEALTHPOINT, LTD BALSAM PERU OIL; CASTOR OIL; TRYPSIN 87; 788; 90 mg/g; mg/g; [USP'U]/g 0064-5010_4a7d5058-59c6-410e-8dec-e30d05a072ca 0064-5010 HUMAN PRESCRIPTION DRUG COLLAGENASE SANTYL COLLAGENASE SANTYL OINTMENT TOPICAL 20061018 BLA BLA101995 HEALTHPOINT, LTD COLLAGENASE CLOSTRIDIUM HISTOLYTICUM 250 [arb'U]/g Collagenases [Chemical/Ingredient],Collagen-specific Enzyme [EPC] 0065-0002_d0ce806c-1f96-4db7-be22-24d1873ae863 0065-0002 HUMAN PRESCRIPTION DRUG NEVANAC nepafenac SUSPENSION OPHTHALMIC 20050906 NDA NDA021862 Alcon Laboratories, Inc. NEPAFENAC 1 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0065-0006_6f90aa43-79b3-c4fa-7a59-337245229d7f 0065-0006 HUMAN PRESCRIPTION DRUG MOXEZA moxifloxacin hydrochloride SOLUTION OPHTHALMIC 20110118 NDA NDA022428 Alcon Laboratories, Inc. MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0065-0023_bea74344-8646-44c0-8979-a686fb265402 0065-0023 HUMAN PRESCRIPTION DRUG MIOSTAT carbachol SOLUTION OPHTHALMIC 19740415 NDA NDA016968 Alcon Laboratories, Inc. CARBACHOL .1 mg/mL 0065-0085_6dfea27f-84de-7c12-81e1-1e1ada280cd4 0065-0085 HUMAN OTC DRUG Naphcon A naphazoline hydrochloride and pheniramine maleate SOLUTION/ DROPS OPHTHALMIC 19940608 NDA NDA020226 Alcon Laboratories, Inc. NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .25; 3 mg/mL; mg/mL 0065-0092_74dbab96-e810-471d-9130-4b7975153c76 0065-0092 HUMAN PRESCRIPTION DRUG FLUORESCITE fluorescein sodium INJECTION, SOLUTION OPHTHALMIC 19720915 NDA NDA021980 Alcon, Inc. FLUORESCEIN SODIUM 100 mg/mL Diagnostic Dye [EPC],Dyes [MoA] 0065-0096_f3ed1cd6-c8d8-4126-8caf-e2b9229a28dd 0065-0096 HUMAN PRESCRIPTION DRUG Flarex fluorometholone acetate SUSPENSION OPHTHALMIC 19920206 NDA NDA019079 Alcon Laboratories, Inc. FLUOROMETHOLONE ACETATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0065-0246_a2957c48-05ee-4300-b55a-11461b4a9548 0065-0246 HUMAN PRESCRIPTION DRUG Betoptic S betaxolol hydrochloride SUSPENSION OPHTHALMIC 19960115 NDA NDA019845 Alcon Laboratories, Inc. BETAXOLOL HYDROCHLORIDE 2.8 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0065-0260_9464bd7e-a00b-8441-52ed-e7442a88ad65 0065-0260 HUMAN PRESCRIPTION DRUG Travatan Z travoprost SOLUTION OPHTHALMIC 20061020 NDA NDA021994 Alcon Laboratories, Inc TRAVOPROST .04 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 0065-0271_d9fc5f0c-e855-4919-8d90-78755533f614 0065-0271 HUMAN PRESCRIPTION DRUG Patanol olopatadine hydrochloride SOLUTION/ DROPS OPHTHALMIC 19970217 NDA NDA020688 Alcon Laboratories, Inc. OLOPATADINE HYDROCHLORIDE 1 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 0065-0272_0faca3f4-e954-44f1-95bf-43ae8a65b4e2 0065-0272 HUMAN PRESCRIPTION DRUG PATADAY olopatadine hydrochloride SOLUTION/ DROPS OPHTHALMIC 20070215 NDA NDA021545 Alcon Laboratories, Inc. OLOPATADINE HYDROCHLORIDE 2 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 0065-0275_fba05aa8-ae46-a5cf-4487-9dc82eed4f9d 0065-0275 HUMAN PRESCRIPTION DRUG Azopt brinzolamide SUSPENSION OPHTHALMIC 19980430 NDA NDA020816 Alcon Laboratories, Inc. BRINZOLAMIDE 10 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] 0065-0325_0807675a-79c7-4d50-9c00-5d42c18bd052 0065-0325 HUMAN PRESCRIPTION DRUG EMADINE EMEDASTINE DIFUMARATE SOLUTION OPHTHALMIC 19980215 NDA NDA020706 Alcon Laboratories, Inc. EMEDASTINE DIFUMARATE .884 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 0065-0332_f66ac0b2-4803-e013-7941-ffa92db8082e 0065-0332 HUMAN PRESCRIPTION DRUG PATANASE olopatadine hydrochloride SPRAY, METERED NASAL 20080428 NDA NDA021861 ALCON LABORATORIES, INC. OLOPATADINE HYDROCHLORIDE 665 ug/1 Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 0065-0333_7bb0d74e-7db8-5fd2-193e-cd1540ed6f7a 0065-0333 HUMAN OTC DRUG ZADITOR ketotifen fumarate SOLUTION OPHTHALMIC 20090922 NDA NDA021066 Alcon Laboratories, Inc. KETOTIFEN FUMARATE .35 mg/mL 0065-0342_496b1b6a-72a1-b825-e3c3-2655a8c20c42 0065-0342 HUMAN PRESCRIPTION DRUG Mydfrin phenylephrine hydrochloride SOLUTION OPHTHALMIC 19790215 UNAPPROVED DRUG OTHER Alcon Laboratories, Inc. PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 0065-0345_d3df0c03-3d1d-4ebd-885a-f139d4507ca3 0065-0345 HUMAN PRESCRIPTION DRUG ALOMIDE lodoxamide tromethamine SOLUTION/ DROPS OPHTHALMIC 19930930 NDA NDA020191 Alcon Laboratories, Inc. LODOXAMIDE TROMETHAMINE 1.78 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] 0065-0355_d62153f0-c46f-4c63-b16a-bbca36149981 0065-0355 HUMAN PRESCRIPTION DRUG Mydriacyl tropicamide SOLUTION OPHTHALMIC 19590401 ANDA ANDA084306 Alcon Laboratories, Inc. TROPICAMIDE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0065-0359_b628f767-5888-40f1-bd62-140aa64632e4 0065-0359 HUMAN PRESCRIPTION DRUG Cyclomydril cyclopentolate hydrochloride and phenylephrine hydrochloride SOLUTION/ DROPS OPHTHALMIC 19580630 ANDA ANDA084300 Alcon Laboratories, Inc. CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10 mg/mL; mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 0065-0395_04b7e0eb-3b7f-4f6f-a84f-14d9abf1749c 0065-0395 HUMAN PRESCRIPTION DRUG Cyclogyl cyclopentolate hydrochloride SOLUTION OPHTHALMIC 19751015 ANDA ANDA084108 Alcon Laboratories, Inc. CYCLOPENTOLATE HYDROCHLORIDE 5 mg/mL 0065-0396_04b7e0eb-3b7f-4f6f-a84f-14d9abf1749c 0065-0396 HUMAN PRESCRIPTION DRUG Cyclogyl cyclopentolate hydrochloride SOLUTION OPHTHALMIC 19751015 ANDA ANDA084108 Alcon Laboratories, Inc. CYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL 0065-0397_04b7e0eb-3b7f-4f6f-a84f-14d9abf1749c 0065-0397 HUMAN PRESCRIPTION DRUG Cyclogyl cyclopentolate hydrochloride SOLUTION OPHTHALMIC 19751015 ANDA ANDA084108 Alcon Laboratories, Inc. CYCLOPENTOLATE HYDROCHLORIDE 20 mg/mL 0065-0411_1cb196ea-0234-4316-b912-d085b9326e89 0065-0411 HUMAN PRESCRIPTION DRUG Betadine povidone-iodine SOLUTION OPHTHALMIC 20000401 NDA NDA018634 Alcon Laboratories, Inc. POVIDONE-IODINE 5 mg/mL 0065-0416_3ca1102f-5239-b759-3b60-727055ad339a 0065-0416 HUMAN OTC DRUG Tears Naturale Free dextran 70, hypromellose 2910 SOLUTION/ DROPS OPHTHALMIC 19901101 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S) 1; 3 mg/mL; mg/mL 0065-0418_74a35013-1c6e-41cb-a867-e2b7bf28187e 0065-0418 HUMAN OTC DRUG Tears Naturale II Polyquad dextran 70 and hypromellose 2910 SOLUTION/ DROPS OPHTHALMIC 19900801 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S) 1; 3 mg/mL; mg/mL 0065-0419_a3df9cbc-2383-ae3c-1a17-8dca671b0d8a 0065-0419 HUMAN OTC DRUG BION TEARS Dextran, Hypromellose SOLUTION/ DROPS OPHTHALMIC 19921019 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S) 1; 3 mg/mL; mg/mL 0065-0426_331cd37b-5826-bd74-adb7-c13167c6fb81 0065-0426 HUMAN OTC DRUG TEARS Naturale FORTE Dextran 70, Glycerin, Hypromellose SOLUTION/ DROPS OPHTHALMIC 20030102 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. DEXTRAN 70; GLYCERIN; HYPROMELLOSES 1; 2; 3 mg/mL; mg/mL; mg/mL 0065-0429_39aedb5c-f253-e94a-8ea9-554d88bf7ebf 0065-0429 HUMAN OTC DRUG Systane Lubricant polyethylene glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20030301 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL 0065-0431_049b9fcf-0d61-4f1f-bd60-9b048600574e 0065-0431 HUMAN OTC DRUG Systane polyethylene glycol 0.4% and propylene glycol 0.3% SOLUTION/ DROPS OPHTHALMIC 20090814 OTC MONOGRAPH FINAL part349 Alcon Research Ltd POLYETHYLENE GLYCOL; PROPYLENE GLYCOL .4; .3 mL/mL; mL/mL 0065-0454_718fb8b3-3933-6f09-1410-7107eedf8547 0065-0454 HUMAN OTC DRUG Systane polyethylene glycol 400 and propylene glycol GEL OPHTHALMIC 20110209 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL 0065-0474_3c2aecf8-04b4-b1a6-69ff-ad039c2175bb 0065-0474 HUMAN OTC DRUG Systane hypromellose GEL OPHTHALMIC 20121215 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. HYPROMELLOSE 2910 (4000 MPA.S) 3 mg/g 0065-0509_a2c681ba-9612-e2ba-a49c-22c4cbdfcb64 0065-0509 HUMAN OTC DRUG Systane Nighttime mineral oil and white petrolatum OINTMENT OPHTHALMIC 20080626 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. MINERAL OIL; PETROLATUM 30; 940 mg/g; mg/g 0065-0530_b783e03c-2e96-9df7-c6b1-eaccd5b358c6 0065-0530 HUMAN OTC DRUG Eye Stream purified water SOLUTION OPHTHALMIC 19900930 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. WATER 986 mg/mL 0065-0543_a2412381-d9ed-4d7e-acb1-a97e730b12db 0065-0543 HUMAN PRESCRIPTION DRUG TRIESENCE triamcinolone acetonide INJECTION OPHTHALMIC 20101001 NDA NDA022048 Alcon Laboratories, Inc. TRIAMCINOLONE ACETONIDE 40 mg/mL 0065-0627_4369f9ff-e961-4c02-b539-264f59ee7892 0065-0627 HUMAN PRESCRIPTION DRUG Vexol rimexolone SUSPENSION OPHTHALMIC 19950915 NDA NDA020474 Alcon Laboratories, Inc RIMEXOLONE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0065-0631_d2e56679-1620-4497-a9a3-5a333e873d5e 0065-0631 HUMAN PRESCRIPTION DRUG MAXITROL neomycin sulfate, polymyxin b sulfate and dexamethasone OINTMENT OPHTHALMIC 19720117 NDA NDA050065 Alcon Laboratories, Inc. DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0065-0638_671f0d1f-fad2-4f27-b4b9-4e2fabd3e83f 0065-0638 HUMAN PRESCRIPTION DRUG OMNIPRED prednisolone acetate SUSPENSION OPHTHALMIC 20071106 NDA NDA017469 Alcon Laboratories, Inc. PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0065-0643_222896e5-38c7-158b-1145-07001b361d5a 0065-0643 HUMAN PRESCRIPTION DRUG Tobrex tobramycin SOLUTION OPHTHALMIC 19810315 NDA NDA050541 Alcon Laboratories, Inc. TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0065-0644_2e5b10f7-9127-4dc0-84bf-0fd88b25d374 0065-0644 HUMAN PRESCRIPTION DRUG TOBREX tobramycin OINTMENT OPHTHALMIC 19810628 NDA NDA050555 Alcon Laboratories, Inc. TOBRAMYCIN 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0065-0645_b703806d-0139-42aa-a8ea-8dd3e9470a98 0065-0645 HUMAN PRESCRIPTION DRUG NATACYN natamycin SUSPENSION OPHTHALMIC 19801231 NDA NDA050514 Alcon Laboratories, Inc. NATAMYCIN 50 mg/mL Polyene Antimicrobial [EPC],Polyenes [Chemical/Ingredient] 0065-0647_8ea6e851-7529-4e50-ba22-92400b6923ed 0065-0647 HUMAN PRESCRIPTION DRUG TobraDex tobramycin and dexamethasone SUSPENSION OPHTHALMIC 19880915 NDA NDA050592 Alcon Laboratories, Inc. DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0065-0648_0c5b0aec-0c14-43b5-a807-cb5ea4928f75 0065-0648 HUMAN PRESCRIPTION DRUG TobraDex tobramycin and dexamethasone OINTMENT OPHTHALMIC 19881015 NDA NDA050616 Alcon Laboratories, Inc. DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0065-0652_9daa066f-64fa-4fd2-9d63-0b71d780ff8d 0065-0652 HUMAN PRESCRIPTION DRUG TOBRADEX ST tobramycin / dexamethasone SUSPENSION OPHTHALMIC 20100907 NDA NDA050818 Alcon Laboratories, Inc. DEXAMETHASONE; TOBRAMYCIN .5; 3 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0065-0654_8a7f41ac-66a6-4812-ac6d-909ea6912579 0065-0654 HUMAN PRESCRIPTION DRUG CILOXAN ciprofloxacin hydrochloride OINTMENT OPHTHALMIC 19980602 NDA NDA020369 Alcon Laboratories, Inc. CIPROFLOXACIN HYDROCHLORIDE 3.33 mg/g Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0065-0656_dfc84b0a-5724-41b3-99fc-e64688fcd4fc 0065-0656 HUMAN PRESCRIPTION DRUG Ciloxan ciprofloxacin hydrochloride SOLUTION OPHTHALMIC 19910115 NDA NDA019992 Alcon Laboratories, Inc. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0065-0660_99b736eb-b121-46d9-b7a0-840cd042363e 0065-0660 HUMAN PRESCRIPTION DRUG IOPIDINE apraclonidine hydrochloride SOLUTION OPHTHALMIC 19880515 NDA NDA019779 Alcon Laboratories, Inc. APRACLONIDINE HYDROCHLORIDE 10 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0065-0665_f59759c2-e814-4998-8800-a646a0f1c2a7 0065-0665 HUMAN PRESCRIPTION DRUG Iopidine apraclonidine SOLUTION OPHTHALMIC 19931001 NDA NDA020258 Alcon Laboratories, Inc. APRACLONIDINE HYDROCHLORIDE 5 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0065-0702_c391d01e-09dc-b032-899a-0352cd74c282 0065-0702 HUMAN PRESCRIPTION DRUG atropine sulfate atropine sulfate SOLUTION OPHTHALMIC 20000612 UNAPPROVED DRUG OTHER Alcon Laboratories, Inc. ATROPINE SULFATE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0065-0741_7bc36479-fa1f-39ee-303a-e671915e09a6 0065-0741 HUMAN PRESCRIPTION DRUG Tetracaine Hydrochloride tetracaine hydrochloride SOLUTION OPHTHALMIC 19690328 UNAPPROVED DRUG OTHER Alcon Laboratories, Inc. TETRACAINE HYDROCHLORIDE 5 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 0065-0795_4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea 0065-0795 HUMAN PRESCRIPTION DRUG BSS balanced salt solution SOLUTION OPHTHALMIC 19690328 NDA NDA020742 Alcon Laboratories, Inc. CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE .48; .3; .75; 3.9; 6.4; 1.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0065-0795_d2f55b3f-0873-4536-aedb-2829a91927c7 0065-0795 HUMAN PRESCRIPTION DRUG BSS balanced salt solution SOLUTION OPHTHALMIC 19690328 NDA NDA020742 Alcon Laboratories, Inc. CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE .48; .3; .75; 3.9; 6.4; 1.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0065-0800_286cc060-8659-c92e-a056-edf6746d3de1 0065-0800 HUMAN PRESCRIPTION DRUG BSS PLUS balanced salt solution enriched with bicarbonate, dextrose, and glutathione KIT 19820628 NDA NDA018469 Alcon Laboratories, Inc. 0065-0800_452b57f7-1b9e-57f3-8555-ad3d7117563d 0065-0800 HUMAN PRESCRIPTION DRUG BSS PLUS balanced salt solution enriched with bicarbonate, dextrose, and glutathione KIT 20130620 NDA NDA018469 Alcon Laboratories, Inc. 0065-0800_bc616aad-0be0-bd23-58d2-cf727aa9bb2a 0065-0800 HUMAN PRESCRIPTION DRUG BSS PLUS balanced salt solution enriched with bicarbonate, dextrose, and glutathione KIT 19820628 NDA NDA018469 Alcon Laboratories, Inc. 0065-1431_04158e63-bdbc-071f-1300-302b3255e943 0065-1431 HUMAN OTC DRUG Systane Ultra Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20091130 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL 0065-1432_5837e14a-3e32-462e-96a3-212b20cc11fa 0065-1432 HUMAN OTC DRUG Systane ULTRA polyethylene glycol 0.4% and propylene glycol 0.3% SOLUTION/ DROPS OPHTHALMIC 20090727 OTC MONOGRAPH FINAL part349 Alcon Research Ltd POLYETHYLENE GLYCOL; PROPYLENE GLYCOL .4; .3 mL/mL; mL/mL 0065-1433_c7b1a03a-a5f2-409e-a34a-d6f166671de5 0065-1433 HUMAN OTC DRUG Systane Balance propylene glycol EMULSION OPHTHALMIC 20100727 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. PROPYLENE GLYCOL .06 mg/mL 0065-1750_0137bde7-f3a1-60dc-8198-1754c08df5c1 0065-1750 HUMAN PRESCRIPTION DRUG ILEVRO nepafenac SUSPENSION OPHTHALMIC 20121220 NDA NDA203491 Alcon Laboratories, Inc. NEPAFENAC 3 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0065-1795_28488c7b-cf6a-4a03-916f-cc66b3afdc57 0065-1795 HUMAN PRESCRIPTION DRUG BSS balanced salt solution SOLUTION OPHTHALMIC 19690328 NDA NDA020742 Alcon Laboratories, Inc. CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE .48; .3; .75; 3.9; 6.4; 1.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0065-2800_2d721281-13c5-a3b6-742a-79251efc14c2 0065-2800 HUMAN PRESCRIPTION DRUG IZBA travoprost SOLUTION OPHTHALMIC 20140602 NDA NDA204822 Alcon Laboratories, Inc. TRAVOPROST .03 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 0065-4011_e4300e4b-b43d-f1fa-6860-1d87ebc9bfa8 0065-4011 HUMAN OTC DRUG Zaditor ketotifen fumarate SOLUTION OPHTHALMIC 20121221 ANDA ANDA077200 Alcon Laboratories, Inc. KETOTIFEN FUMARATE .35 mg/mL 0065-4013_48fc0ac4-6192-6fc8-90f8-97bb35aaa1a0 0065-4013 HUMAN PRESCRIPTION DRUG VIGAMOX moxifloxacin hydrochloride SOLUTION OPHTHALMIC 20030507 NDA NDA021598 Alcon Laboratories, Inc. MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0065-4147_668bddfa-a083-d9a3-3823-818504c59e73 0065-4147 HUMAN PRESCRIPTION DRUG SIMBRINZA brinzolamide/brimonidine tartrate SUSPENSION/ DROPS OPHTHALMIC 20130501 NDA NDA204251 Alcon Laboratories, Inc. BRIMONIDINE TARTRATE; BRINZOLAMIDE 2; 10 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0065-8531_f89ae7a5-0aeb-4e66-b406-973eb90c48c3 0065-8531 HUMAN PRESCRIPTION DRUG CIPRO HC ciprofloxacin hydrochloride and hydrocortisone SUSPENSION AURICULAR (OTIC) 19990315 NDA NDA020805 Alcon Laboratories, Inc. CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE 2; 10 mg/mL; mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0065-8533_2ea874af-d374-43cc-ae82-6f98084d8e45 0065-8533 HUMAN PRESCRIPTION DRUG CIPRODEX ciprofloxacin and dexamethasone SUSPENSION AURICULAR (OTIC) 20030815 NDA NDA021537 Alcon, Inc. CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE 3; 1 mg/mL; mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0065-9240_983dd12c-2fb5-48cc-a954-5f61c18861e0 0065-9240 HUMAN PRESCRIPTION DRUG DUREZOL DUREZOL EMULSION OPHTHALMIC 20110125 NDA NDA022212 Alcon Laboratories, Inc. DIFLUPREDNATE .5 mg/mL 0066-0507_fd24a643-1331-4ac6-a7b6-3c9c733f5c42 0066-0507 HUMAN PRESCRIPTION DRUG Dermatop prednicarbate CREAM TOPICAL 19931029 20150930 NDA NDA020279 Dermik Laboratories PREDNICARBATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0066-0508_a80b05f6-fea8-4138-a8a1-a156007700cc 0066-0508 HUMAN PRESCRIPTION DRUG Dermatop prednicarbate OINTMENT TOPICAL 19910923 20150630 NDA NDA019568 Dermik Laboratories PREDNICARBATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0066-0510_6a7a92f3-a91d-491c-9309-4c73c7e90f62 0066-0510 HUMAN PRESCRIPTION DRUG Benzamycin erythromycin and benzoyl peroxide KIT 19850101 20160131 NDA NDA050557 Dermik Laboratories 0066-7150_e1573ba5-b3c1-49b2-a7b5-55d2f5b66355 0066-7150 HUMAN PRESCRIPTION DRUG Carac fluorouracil CREAM TOPICAL 20001027 20151130 NDA NDA020985 Dermik Laboratories FLUOROURACIL 5 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0067-0003_62544c2f-6e30-4cec-ae63-233715ef0699 0067-0003 HUMAN OTC DRUG EX-LAX REGULAR STRENGTH STIMULANT LAXATIVE SENNOSIDES PILL ORAL 20120101 OTC MONOGRAPH NOT FINAL part334 Novartis Consumer Health, Inc. SENNOSIDES 15 mg/1 0067-0005_2309bcee-5eb1-45a6-921d-ad788f37c67e 0067-0005 HUMAN OTC DRUG EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE SENNOSIDES TABLET, CHEWABLE ORAL 20100101 OTC MONOGRAPH NOT FINAL part334 Novartis Consumer Health, Inc. SENNOSIDES 15 mg/1 0067-0016_800366b2-e974-4791-9a0d-c341c80ac859 0067-0016 HUMAN OTC DRUG EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE SENNOSIDES PILL ORAL 20120101 OTC MONOGRAPH NOT FINAL part334 Novartis Consumer Health, Inc. SENNOSIDES 25 mg/1 0067-0113_c70b8a69-f853-4981-aff5-389aa58f7169 0067-0113 HUMAN OTC DRUG Gas-X Regular Strength Chewable Cherry Simethicone TABLET, CHEWABLE ORAL 20120101 OTC MONOGRAPH FINAL part332 Novartis Consumer Health, Inc. DIMETHICONE 80 mg/1 0067-0116_86804088-9f48-4a3b-9be3-17bad6e26a81 0067-0116 HUMAN OTC DRUG Gas-X Regular Strength Chewable Peppermint Simethicone TABLET, CHEWABLE ORAL 20120101 OTC MONOGRAPH FINAL part332 Novartis Consumer Health Inc. DIMETHICONE 80 mg/1 0067-0117_d885096d-99cb-4232-bf0e-06aa811551a4 0067-0117 HUMAN OTC DRUG Gas-X Extra Strength Simethicone TABLET, CHEWABLE ORAL 20120101 OTC MONOGRAPH FINAL part332 Novartis Consumer Health DIMETHICONE 125 mg/1 0067-0129_a8312477-f0f2-408c-a6c3-ca371e379c62 0067-0129 HUMAN OTC DRUG Gas-X Extra Strength Simethicone TABLET, CHEWABLE ORAL 20120101 OTC MONOGRAPH FINAL part332 Novartis Consumer Health DIMETHICONE 125 mg/1 0067-0134_980362cf-1d15-4286-8ab8-bfeac7d34f4a 0067-0134 HUMAN OTC DRUG Gas-X Extra Strength Simethicone GEL ORAL 20101027 OTC MONOGRAPH FINAL part332 Novartis Consumer Health, Inc. DIMETHICONE 125 mg/1 0067-0143_ca296e03-59d2-4cc2-83b8-8fd7f6241fc6 0067-0143 HUMAN OTC DRUG Ascriptin Maximum Strength Buffered Aspirin Aspirin TABLET, FILM COATED ORAL 20091231 OTC MONOGRAPH FINAL part343 Novartis Consumer Health, Inc. ASPIRIN 500 mg/1 0067-0149_4f676dc2-71de-431a-82ef-53c6bb9a6e01 0067-0149 HUMAN OTC DRUG Ascriptin Regular Strength Buffered Aspirin Aspirin TABLET, FILM COATED ORAL 20090924 OTC MONOGRAPH FINAL part343 Novartis Consumer Health, Inc. ASPIRIN 325 mg/1 0067-0949_c2ec4973-07d6-480f-b47a-ac57b4b703f1 0067-0949 HUMAN OTC DRUG Desenex MICONAZOLE NITRATE POWDER TOPICAL 20090803 OTC MONOGRAPH FINAL part333C Novartis Consumer Health, Inc. MICONAZOLE NITRATE 2 g/100g 0067-0959_86f0e58f-26ae-4f06-9c4e-751f3c66257e 0067-0959 HUMAN OTC DRUG Desenex MICONAZOLE NITRATE AEROSOL, POWDER TOPICAL 20060201 OTC MONOGRAPH FINAL part333C Novartis Consumer Health, Inc. MICONAZOLE NITRATE 2 g/100g 0067-0969_8fc53acf-6393-44a4-adcf-18f5b506c8d2 0067-0969 HUMAN OTC DRUG Desenex MICONAZOLE NITRATE AEROSOL, SPRAY TOPICAL 20060201 OTC MONOGRAPH FINAL part333C Novartis Consumer Health, Inc. MICONAZOLE NITRATE 2 g/100g 0067-1170_94baa7ac-b84b-4ca7-ac4a-c915ad8bf2e3 0067-1170 HUMAN OTC DRUG Myoflex Pain Relieving Cream Trolamine salicylate 10% CREAM CUTANEOUS 20111221 OTC MONOGRAPH NOT FINAL part348 Novartis Consumer Health, Inc. TROLAMINE SALICYLATE 10 g/1 0067-1190_fbfa10f7-6bcc-4904-b375-9b9c1cdfaf11 0067-1190 HUMAN OTC DRUG TAVIST ALLERGY Clemastine fumarate TABLET ORAL 20100101 NDA NDA020925 Novartis Consumer Health, Inc. CLEMASTINE FUMARATE 1.34 mg/1 0067-2000_dea3d3e3-03c3-4059-982e-108aaa1867c8 0067-2000 HUMAN OTC DRUG Excedrin Extra Strength Pain Reliever Acetaminophen, Aspirin (NSAID), and Caffeine TABLET, FILM COATED ORAL 20060927 OTC MONOGRAPH NOT FINAL part343 Novartis Consumer Health, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0067-2021_11a8439b-0159-4351-b0f5-fe7fad6a33c0 0067-2021 HUMAN OTC DRUG Excedrin Extra Strength Geltabs Acetaminophen, Asprin, Caffeine TABLET, COATED ORAL 20110913 OTC MONOGRAPH NOT FINAL part343 Novartis Consumer Health, Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0067-2030_0e09dc0d-9c5f-4e2b-b1c9-c365c30dd476 0067-2030 HUMAN OTC DRUG Excedrin Extra Strength Acetaminophen, Aspirin (NSAID), and Caffeine TABLET, FILM COATED ORAL 20060927 OTC MONOGRAPH NOT FINAL part343 Novartis Consumer Health, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0067-2035_cc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff8 0067-2035 HUMAN OTC DRUG Excedrin Migraine Geltabs Acetaminophen, Asprin, Caffeine TABLET, COATED ORAL 20110913 NDA NDA020802 Novartis Consumer Health, Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0067-2037_bdd243cd-972d-4ea5-9877-7b96d528a7e2 0067-2037 HUMAN OTC DRUG EXCEDRIN MIGRAINE Acetaminophen, Aspirin and Caffeine TABLET, FILM COATED ORAL 20100215 NDA NDA020802 Novartis Consumer Health, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0067-2039_9c6c9f12-1f92-4f87-b8dd-7024eda5aab6 0067-2039 HUMAN OTC DRUG EXCEDRIN MIGRAINE Acetaminophen, Aspirin (NSAID) and Caffeine TABLET, FILM COATED ORAL 20100215 NDA NDA020802 Novartis Consumer Health, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0067-2045_cc17ee50-1401-4b31-8c01-e153b4291c7a 0067-2045 HUMAN OTC DRUG EXCEDRIN Tension Headache Acetaminophine, caffeine TABLET, FILM COATED ORAL 20051031 OTC MONOGRAPH FINAL part343 Novartis Consumer Health, Inc. ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 0067-2053_375ba5bf-16c1-4912-9aa1-a8e7196aed31 0067-2053 HUMAN OTC DRUG Excedrin PM Acetaminophen, Diphenhydramine Citrate TABLET ORAL 20100301 OTC MONOGRAPH FINAL part343 Novartis Consumer Health, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 0067-2055_57ca5972-09b5-45e7-848f-367ebc633ea2 0067-2055 HUMAN OTC DRUG Excedrin PM Acetaminophen, Diphenhydramine Citrate TABLET, FILM COATED ORAL 20090701 OTC MONOGRAPH FINAL part343 Novartis Consumer Health, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 0067-2056_b3812d27-40af-40d7-864a-dfa4ae34cb9e 0067-2056 HUMAN OTC DRUG Excedrin PM Triple Action Caplets Acetaminophen, Aspirin (NSAID) and Diphenhydramine Citrate TABLET, COATED ORAL 20140924 OTC MONOGRAPH NOT FINAL part343 Novartis Consumer Health, Inc. ACETAMINOPHEN; ASPIRIN; DIPHENHYDRAMINE CITRATE 250; 250; 38 mg/1; mg/1; mg/1 0067-2067_aa7e4592-76d4-43cd-9e4b-3a112672c305 0067-2067 HUMAN OTC DRUG Mineral Ice Pain Relieving Menthol GEL TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part348 Novartis Consumer Health, Inc. MENTHOL .02 g/g 0067-2070_7ef8b03c-245a-424f-bf75-438559c4418b 0067-2070 HUMAN OTC DRUG NoDoz MAXIMUM STRENGTH ALERTNESS AID Caffine TABLET, COATED ORAL 20091231 OTC MONOGRAPH FINAL part340 Novartis Consumer Health, Inc. CAFFEINE 200 mg/1 0067-2077_717009a9-877f-47ac-971f-f44c87ef5e5a 0067-2077 HUMAN OTC DRUG COMTREX Maximum Strength Cold and Cough Non-Drowsy Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET, COATED ORAL 20061208 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 15 mg/1; mg/1; mg/1 0067-2083_801d3659-d0e8-4c3b-ac03-4fc0b9b211dc 0067-2083 HUMAN OTC DRUG COMTREX Maximum Strength Day / Night Severe Cold and Sinus Acetaminophen, Chlorpheniramine Maleate, Phenylephrin HCl KIT 20100701 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. 0067-2086_5e857646-9619-4d12-854a-66c41490356e 0067-2086 HUMAN OTC DRUG 4 Way Fast Acting Phenylephrine hydrochloride SPRAY NASAL 20100101 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL 0067-2090_78ebebac-fc6a-42b9-a402-8a830c51a043 0067-2090 HUMAN OTC DRUG Vagistat-1 Tioconazole OINTMENT VAGINAL 19970211 NDA NDA020676 Novartis Consumer Health, Inc TIOCONAZOLE 300 mg/1 0067-2091_c91cba6b-61fc-4708-9edb-3ba086cc1038 0067-2091 HUMAN OTC DRUG Vagistat-3 Miconazole nitrate KIT 20000225 ANDA ANDA075329 Novartis Consumer Health, Inc. 0067-2094_e15b44f1-fda7-4140-bdc4-7ce626f2bd03 0067-2094 HUMAN OTC DRUG 4 Way Moisturizing Relief Phenylephrine hydrochloride SPRAY NASAL 20100101 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. XYLOMETAZOLINE HYDROCHLORIDE .01 L/L 0067-3998_14072289-a79f-4556-a9e9-bf28a1ed8025 0067-3998 HUMAN OTC DRUG Lamisil AT TERBINAFINE HYDROCHLORIDE CREAM TOPICAL 20050810 NDA NDA020980 Novartis Consumer Health, Inc. TERBINAFINE HYDROCHLORIDE 10 mg/g 0067-3999_1757a9c4-e989-4f2d-bedc-0ba5137c68dc 0067-3999 HUMAN OTC DRUG Lamisil AT Jock Itch TERBINAFINE HYDROCHLORIDE CREAM TOPICAL 20061208 NDA NDA020980 Novartis Consumer Health, Inc. TERBINAFINE HYDROCHLORIDE 10 mg/g 0067-4000_e74fbb63-b66b-4f2e-ab77-f3916d73540f 0067-4000 HUMAN OTC DRUG LAMISIL AT TERBINAFINE HYDROCHLORIDE SPRAY TOPICAL 20000501 NDA NDA021124 Novartis Consumer Health, Inc. TERBINAFINE HYDROCHLORIDE 1 mL/100mL 0067-4345_99ea3737-e82b-44eb-b125-b20e43e5044d 0067-4345 HUMAN PRESCRIPTION DRUG Transderm Scop scopolamine PATCH, EXTENDED RELEASE TRANSDERMAL 20071002 NDA NDA017874 Novatris Consumer Health, Inc. SCOPOLAMINE 1 mg/3d Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0067-4850_066bc3e8-678e-4ae1-9220-201a2dd9f37a 0067-4850 HUMAN OTC DRUG Habitrol Patch Nicotine Transdermal System, Step 3 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20030226 NDA NDA020076 Novartis Consumer Health, Inc. NICOTINE 7 mg/24h 0067-4860_cc4416c6-e620-44c0-a6b4-433bbe6cba37 0067-4860 HUMAN OTC DRUG Habitrol Patch Nicotine Transdermal System, Step 2 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20030226 NDA NDA020076 Novartis Consumer Health, Inc. NICOTINE 14 mg/24h 0067-4870_92761472-2bdb-4ef9-9c81-a39b1852d7e0 0067-4870 HUMAN OTC DRUG Habitrol Patch Nicotine Transdermal System, Step 1 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20030226 NDA NDA020076 Novartis Consumer Health, Inc. NICOTINE 21 mg/24h 0067-4920_6caf783a-5a67-492c-a84d-da1c1138e90f 0067-4920 HUMAN OTC DRUG American Fare Nicotine Transdermal System Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20120102 NDA NDA020076 Novartis Consumer Health, Inc. NICOTINE 14 mg/1 0067-4970_a7467362-ae8e-4ab0-ac02-0e1ee5c9edc4 0067-4970 HUMAN OTC DRUG SAFEWAY NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20071107 NDA NDA020076 Novartis Consumer Health NICOTINE 7 mg/24h 0067-4980_a7467362-ae8e-4ab0-ac02-0e1ee5c9edc4 0067-4980 HUMAN OTC DRUG SAFEWAY NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20071107 NDA NDA020076 Novartis Consumer Health NICOTINE 14 mg/24h 0067-4990_a7467362-ae8e-4ab0-ac02-0e1ee5c9edc4 0067-4990 HUMAN OTC DRUG SAFEWAY NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20071107 NDA NDA020076 Novartis Consumer Health NICOTINE 21 mg/24h 0067-5000_e3b6995e-ed95-4463-9a77-d30a81c63d93 0067-5000 HUMAN OTC DRUG KROGER NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 Novartis Consumer Health NICOTINE 7 mg/24h 0067-5010_e3b6995e-ed95-4463-9a77-d30a81c63d93 0067-5010 HUMAN OTC DRUG KROGER NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 Novartis Consumer Health NICOTINE 14 mg/24h 0067-5020_e3b6995e-ed95-4463-9a77-d30a81c63d93 0067-5020 HUMAN OTC DRUG KROGER NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 Novartis Consumer Health NICOTINE 21 mg/24h 0067-5050_5fed7712-495a-44f7-8d2d-dc5e0bd44290 0067-5050 HUMAN OTC DRUG EQUALINE NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20060102 20150630 NDA NDA020076 Novartis Consumer Health NICOTINE 21 mg/24h 0067-5060_f5bbd895-c2c4-41c7-94cf-1b5c1a38509f 0067-5060 HUMAN OTC DRUG Rite Aid Nicotine Transdermal System Step 3 Nicotine PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 Novartis Consumer Health NICOTINE 7 mg/24h 0067-5070_f5bbd895-c2c4-41c7-94cf-1b5c1a38509f 0067-5070 HUMAN OTC DRUG Rite Aid Nicotine Transdermal System Step 2 Nicotine PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 Novartis Consumer Health NICOTINE 14 mg/24h 0067-5080_f5bbd895-c2c4-41c7-94cf-1b5c1a38509f 0067-5080 HUMAN OTC DRUG Rite Aid Nicotine Transdermal System Step 1 Nicotine PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 Novartis Consumer Health NICOTINE 21 mg/24h 0067-5124_c50855ec-9dca-4267-b80e-4a5631b40fc4 0067-5124 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 19991112 NDA NDA020076 Novartis Consumer Health, Inc. NICOTINE 7 mg/24h 0067-5125_e39033dd-b94b-4e9d-babc-a56a413db7df 0067-5125 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 19991112 NDA NDA020076 Novartis Consumer Health, Inc. NICOTINE 14 mg/24h 0067-5126_820f18bf-5501-48f4-9ead-934484387524 0067-5126 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 19991112 NDA NDA020076 Novartis Consumer Health, Inc. NICOTINE 21 mg/24h 0067-6011_15222328-8031-4303-b6af-0ae617aa2cff 0067-6011 HUMAN OTC DRUG Meijer NICOTINE TRANSDERMAL SYSTEM Step 3 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20071105 NDA NDA020076 Novartis Consumer Health NICOTINE 7 mg/1 0067-6012_24ca5a20-ce04-4b9b-9676-e128dd7ab020 0067-6012 HUMAN OTC DRUG Meijer NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20071105 NDA NDA020076 Novartis Consumer Health NICOTINE 21 mg/24h 0067-6013_e6681e9d-cde2-4184-b76f-bf7b01a6f8bc 0067-6013 HUMAN OTC DRUG Meijer NICOTINE TRANSDERMAL SYSTEM Step 1 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20071105 NDA NDA020076 Novartis Consumer Health NICOTINE 21 mg/1 0067-6025_7374ae02-74d4-4250-9116-21872e9545ed 0067-6025 HUMAN OTC DRUG Perdiem Sennosides, stimulant laxative PILL ORAL 20071101 OTC MONOGRAPH NOT FINAL part334 Novartis Consumer Health SENNOSIDES 15 mg/1 0067-6045_e555de67-674b-495f-9784-342143ec51eb 0067-6045 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM PATCH KIT NICOTINE KIT 20040721 NDA NDA020076 Novartis Consumer Health, Inc. 0067-6046_45ae63bd-b700-4404-8d83-0e33d76846e7 0067-6046 HUMAN OTC DRUG EXCHANGE SELECT NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20071105 NDA NDA020076 Novartis Consumer Health NICOTINE 7 mg/24h 0067-6051_7128c76a-1308-41a2-be46-a6e9a4e96719 0067-6051 HUMAN OTC DRUG CareOne Nicotine Transdermal System Step 3 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20071207 NDA NDA020076 Novartis Consumer Health, Inc. NICOTINE 7 mg/1 0067-6052_7128c76a-1308-41a2-be46-a6e9a4e96719 0067-6052 HUMAN OTC DRUG CareOne Nicotine Transdermal System Step 2 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20071102 NDA NDA020076 Novartis Consumer Health, Inc. NICOTINE 14 mg/1 0067-6053_7128c76a-1308-41a2-be46-a6e9a4e96719 0067-6053 HUMAN OTC DRUG CareOne Nicotine Transdermal System Step 1 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20071102 NDA NDA020076 Novartis Consumer Health, Inc. NICOTINE 21 mg/1 0067-6066_7a2f0eef-7803-497d-926c-a6163a89eb56 0067-6066 HUMAN OTC DRUG allergy relief loratadine TABLET ORAL 20100104 NDA NDA075209 Novartis Consumer Health, Inc. LORATADINE 10 mg/1 0067-6070_bd385a9f-f82f-4965-83fd-273c795f9b4f 0067-6070 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20040930 NDA NDA021375 Novartis Consumer Health, Inc. LORATADINE 10 mg/1 0067-6114_36393a51-bca1-4c47-9ba0-94ceff5bd1ae 0067-6114 HUMAN OTC DRUG LAMISL AF DEFENSE Tolnaftate AEROSOL, SPRAY TOPICAL 20060201 OTC MONOGRAPH FINAL part333C Novartis Consumer Health, Inc. TOLNAFTATE 10 mg/g 0067-6117_5dcf31c6-5be7-45c8-8c89-42b735b5ae8b 0067-6117 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20040930 NDA NDA021375 Novartis Consumer Health, Inc. LORATADINE 10 mg/1 0067-6122_6f8c55ff-124b-4e91-893d-5e7c5663b60b 0067-6122 HUMAN OTC DRUG allergy relief loratadine TABLET ORAL 20100111 NDA NDA075209 Novartsi Consumer Health, Inc. LORATADINE 10 mg/1 0067-6128_b8be838f-37b7-46b3-9dfd-ec2294cf22e4 0067-6128 HUMAN OTC DRUG SUNMARK NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 Novartis Consumer Health, Inc. NICOTINE 7 mg/24h 0067-6129_b8be838f-37b7-46b3-9dfd-ec2294cf22e4 0067-6129 HUMAN OTC DRUG SUNMARK NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 Novartis Consumer Health, Inc. NICOTINE 14 mg/24h 0067-6130_b8be838f-37b7-46b3-9dfd-ec2294cf22e4 0067-6130 HUMAN OTC DRUG SUNMARK NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 Novartis Consumer Health, Inc. NICOTINE 21 mg/24h 0067-6171_b666efb8-bcff-43da-8c45-1e223f8a12f0 0067-6171 HUMAN OTC DRUG Lamisil AT TERBINAFINE HYDROCHLORIDE CREAM TOPICAL 20050810 NDA NDA020980 Novartis Consumer Health, Inc. TERBINAFINE HYDROCHLORIDE 10 mg/g 0067-6238_4b77be54-e962-4e6b-a244-e3d53a8fecd9 0067-6238 HUMAN OTC DRUG EXCEDRIN BACK AND BODY Acetaminophen, Aspirin TABLET, FILM COATED ORAL 20100215 OTC MONOGRAPH FINAL part343 Novartis Consumer Health, Inc. ACETAMINOPHEN; ASPIRIN 250; 250 mg/1; mg/1 0067-6239_02859315-2972-4db0-b18a-b787385a6072 0067-6239 HUMAN OTC DRUG LAMISIL AT ANTIFUNGAL TERBINAFINE GEL TOPICAL 20100101 NDA NDA021958 Novartis Consumer Health, Inc. TERBINAFINE 10 mg/g 0067-6266_c0ad1ce5-bdb3-43cc-8d07-84f250eb289f 0067-6266 HUMAN OTC DRUG LAMISL AF DEFENSE Tolnaftate CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Novartis Consumer Health, Inc. TOLNAFTATE 10 mg/g 0067-6274_ee9a8404-0653-433f-90e5-7ac69bdab8df 0067-6274 HUMAN OTC DRUG Gas-X Ultra Strength AntiGas Softgels Simethicone CAPSULE, LIQUID FILLED ORAL 20070901 OTC MONOGRAPH FINAL part332 Novartis Consumer Health Inc. DIMETHICONE 180 mg/1 0067-6275_925a95c3-fa9f-453d-97c7-4c5563da0067 0067-6275 HUMAN OTC DRUG Gas-X Extra Strength Softgels Simethicone CAPSULE, LIQUID FILLED ORAL 20110912 OTC MONOGRAPH FINAL part332 Novartis Consumer Health, Inc. DIMETHICONE 125 mg/1 0067-6280_1ee52d89-b40e-4d8d-aed9-6b1aced5d75a 0067-6280 HUMAN OTC DRUG Maalox Advanced Maximum Strength Cherry Aluminum Hydroxide, Magnesium Hydroxide,Simethicone LIQUID ORAL 20080306 OTC MONOGRAPH FINAL part332 Novartis Consumer Health, Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 0067-6281_57b3a01f-e2c8-4e5f-8790-368e270cf423 0067-6281 HUMAN OTC DRUG Maalox Advanced Regular Strength Mint Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20080404 OTC MONOGRAPH FINAL part332 Novartis Consumer Health, Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 0067-6282_ac12f0ae-6f06-4fa4-8265-37d27db8cb5d 0067-6282 HUMAN OTC DRUG Maalox Advanced Maximum Strength Mint Aluminum Hydroxide, Magnesium Hydroxide,Simethicone LIQUID ORAL 20080306 OTC MONOGRAPH FINAL part332 Novartis Consumer Health, Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 0067-6286_9edfd43b-ecbd-40b7-8471-5b967e514f3c 0067-6286 HUMAN OTC DRUG Prevacid 24 HR Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091012 NDA NDA022327 Novartis Consumer Health LANSOPRAZOLE 15 mg/1 0067-6290_ff859c0c-083c-4b6c-bc24-59a8896a63ce 0067-6290 HUMAN OTC DRUG Maalox Advanced Maximum Strength Wild Berry Aluminum Hydroxide, Magnesium Hydroxide,Simethicone LIQUID ORAL 20080306 OTC MONOGRAPH FINAL part332 Novartis Consumer Health, Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 0067-6291_fc454ce5-633d-4128-85f2-8d6223f99787 0067-6291 HUMAN OTC DRUG Maalox Advanced Maximum Strength Antacid and Antigas TABLET, CHEWABLE ORAL 20061212 OTC MONOGRAPH FINAL part332 Novartis Consumer Health, Inc. DIMETHICONE 60 mg/1 0067-6292_8a8f2d12-a621-4334-b790-7879704aeff8 0067-6292 HUMAN OTC DRUG LAMISIL AT Continuous Spray TERBINAFINE HYDROCHLORIDE LIQUID TOPICAL 20090723 NDA NDA021124 Novartis Consumer Health, Inc. TERBINAFINE HYDROCHLORIDE 1.25 mL/125mL 0067-6293_cab1adfd-d20e-47ae-9c80-b023401b4633 0067-6293 HUMAN OTC DRUG LAMISIL AT Continuous Spray TERBINAFINE HYDROCHLORIDE LIQUID TOPICAL 20090723 NDA NDA021124 Novartis Consumer Health, Inc. TERBINAFINE HYDROCHLORIDE 1.25 mL/125mL 0067-6318_b9bc72b1-eebf-475f-99a8-0b2c9825e878 0067-6318 HUMAN OTC DRUG THERAFLU SUGAR FREE NIGHTIME SEVERE COLD AND COUGH ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE POWDER, FOR SOLUTION ORAL 20090810 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 0067-6319_46932df8-87ca-4e15-8239-afb14127f3ee 0067-6319 HUMAN OTC DRUG Theraflu Sinus and Cold Acetaminophen, Pheniramine Maleate, Phenylephrine HCl POWDER, FOR SOLUTION ORAL 20080516 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 20; 10 mg/1; mg/1; mg/1 0067-6341_5afd3b6f-f33d-4cdb-990c-b96b5aa1a31b 0067-6341 HUMAN OTC DRUG Excedrin Menstrual Complete Acetaminophen, Asprin (NSAID) and Caffine CAPSULE, GELATIN COATED ORAL 20091210 OTC MONOGRAPH FINAL part343 Novartis Consumer Health, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0067-6344_00f66f25-3469-4c16-9baf-fba21e9628bd 0067-6344 HUMAN OTC DRUG TRIAMINIC Childrens Night Time Cold and Cough Diphenhydramine HCl, Phenylephrine HCl SYRUP ORAL 20080926 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 0067-6345_4bf1db28-b8d9-4bc2-a3fa-ae20a8e6537b 0067-6345 HUMAN OTC DRUG Triaminic Day Time Cold and Cough Dextromethorphan HBr, Phenylephrine HCl SYRUP ORAL 20111101 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 0067-6346_0fc400f2-fd87-4516-af0b-f7d3e0753717 0067-6346 HUMAN OTC DRUG TRIAMINIC Childrens Cold and Allergy Chlorpheniramine maleate, Phenylephrine HCl SYRUP ORAL 20080926 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 0067-6347_b4a55555-74a6-42f7-a843-82e94fbc389e 0067-6347 HUMAN OTC DRUG Triaminic Chest and Nasal Congestion Guaifenesin, Phenylephrine HCl SYRUP ORAL 20111101 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 50; 2.5 mg/5mL; mg/5mL 0067-6348_bccbf604-768c-4e20-995a-bb0212374202 0067-6348 HUMAN OTC DRUG Triaminic Cough and Sore Throat Acetaminophen, Dextromethorphan HBr SYRUP ORAL 20080906 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 5 mg/5mL; mg/5mL 0067-6350_83bb1f25-23e8-4827-bfc4-25ff3c87de18 0067-6350 HUMAN OTC DRUG Triaminic Long Acting Cough Dextromethorphan HBr SYRUP ORAL 20111208 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg/5mL 0067-6394_f2fff324-bbb8-405a-b085-460afbaba097 0067-6394 HUMAN OTC DRUG Triaminic Multi-Symptom Fever Acetaminophen, Chlorpheniramine maleate, Dextromethorphan SYRUP ORAL 20120927 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 7.5 mg/5mL; mg/5mL; mg/5mL 0067-6395_be105f3f-0205-417b-894a-e5d8fcfc9b94 0067-6395 HUMAN OTC DRUG Theraflu Warming Relief Nighttime Multi-Symptom Cold Caplets Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephreine HCI TABLET, COATED ORAL 20090902 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 0067-6396_d1792be4-f6e2-4f62-ae7a-c016722f6202 0067-6396 HUMAN OTC DRUG Theraflu Warming Relief Daytime Multi-Symptom Cold Caplets Acetaminophen, Dextromethorphan HBr, Phenylephreine HCI TABLET, COATED ORAL 20090902 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 0067-6416_a3386d18-845f-48df-89f3-95d71400247b 0067-6416 HUMAN OTC DRUG athletes foot terbinafin hydrochloride CREAM TOPICAL 20090831 NDA NDA020980 Novartis Cosnumer Health, Inc TERBINAFINE HYDROCHLORIDE 10 mg/g 0067-6424_46f1c9a8-590f-47db-a060-4be0c59f55ca 0067-6424 HUMAN OTC DRUG BUFFERIN LOW DOSE BUFFERED ASPIRIN ASPIRIN TABLET ORAL 20110311 OTC MONOGRAPH FINAL part343 Novartis Consumer Health, Inc. ASPIRIN 81 mg/1 0067-6426_94a593f0-e819-43c1-9492-a8bf775574e2 0067-6426 HUMAN OTC DRUG THERAFLU MULTI SYMPTOM SEVERE COLD ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl POWDER, FOR SOLUTION ORAL 20140701 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 0067-6427_e71c1e5b-9783-4481-b163-0a9877a5031b 0067-6427 HUMAN OTC DRUG Theraflu Max-D ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl POWDER, FOR SOLUTION ORAL 20100801 OTC MONOGRAPH NOT FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 1000; 30; 400; 60 mg/1; mg/1; mg/1; mg/1 0067-6431_56564534-8ff7-43e3-87d4-b55269aca004 0067-6431 HUMAN OTC DRUG Triaminic Fever Reducer ACETAMINOPHEN SYRUP ORAL 20100601 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN 160 mg/5mL 0067-6432_56564534-8ff7-43e3-87d4-b55269aca004 0067-6432 HUMAN OTC DRUG Triaminic Fever Reducer ACETAMINOPHEN SYRUP ORAL 20100601 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN 160 mg/5mL 0067-6440_d8b68434-2d0b-4431-b79d-7d6510f50e1b 0067-6440 HUMAN OTC DRUG Triaminic Infants Fever Reducer Pain Reliever - Grape ACETAMINOPHEN SYRUP ORAL 20120926 OTC MONOGRAPH NOT FINAL part343 Novartis Consumer Health, Inc. ACETAMINOPHEN 160 mg/5mL 0067-6441_d8b68434-2d0b-4431-b79d-7d6510f50e1b 0067-6441 HUMAN OTC DRUG Triaminic Infants Fever Reducer Pain Reliever - Bubblegum ACETAMINOPHEN SYRUP ORAL 20120926 OTC MONOGRAPH NOT FINAL part343 Novartis Consumer Health, Inc. ACETAMINOPHEN 160 mg/5mL 0067-6716_6172fb35-a310-452a-aeef-ef148e1cbf25 0067-6716 HUMAN OTC DRUG Theraflu Cold and Sore Throat Acetaminophen, Pheniramine Maleate, Phenylephrine HCl POWDER, FOR SOLUTION ORAL 20050527 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 20; 10 mg/1; mg/1; mg/1 0067-7916_44e1e7b4-d867-4aab-9a51-7a72456eeaa0 0067-7916 HUMAN OTC DRUG Theraflu Flu and Sore Throat Acetaminophen, Pheniramine Maleate, Phenylephrine HCl POWDER, FOR SOLUTION ORAL 20050513 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 0067-7917_c0689223-5c90-4dbc-bbfa-f94e267504c3 0067-7917 HUMAN OTC DRUG Theraflu Daytime Severe Cold and Cough ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE POWDER, FOR SOLUTION ORAL 20120924 OTC MONOGRAPH FINAL part341 Novartis Consumer Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 0067-7918_e839a10c-e70f-4702-86c1-4bc83da123de 0067-7918 HUMAN OTC DRUG THERAFLU NIGHTTIME SEVERE COLD AND COUGH ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL POWDER, FOR SOLUTION ORAL 20140701 OTC MONOGRAPH FINAL part341 Novartis Consumer Health ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 0067-8100_532f0f10-33b0-41d2-9781-da34dea341ba 0067-8100 HUMAN OTC DRUG Lamisil AT Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Novartis Consumer Health, Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g 0067-8103_f0069d4c-4993-4b47-8bcf-067e4e9cd6a3 0067-8103 HUMAN OTC DRUG Excedrin Migraine Acetaminophen, Aspirin (NSAID) and Caffeine TABLET, FILM COATED ORAL 20121022 ANDA ANDA075794 Novartis Consumer Health, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0067-8104_63d1a6d4-6bd7-468c-9b5b-3f6f059fb3d2 0067-8104 HUMAN OTC DRUG Excedrin Extra Strength Caplets Acetaminophen, Aspirin (NSAID), and Caffeine TABLET, FILM COATED ORAL 20130116 OTC MONOGRAPH NOT FINAL part343 Novartis Consumer Health, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0067-8105_9437b637-fb70-41dd-8ead-d79698a61e22 0067-8105 HUMAN OTC DRUG Triaminic Day Time Cold and Cough Dextromethorphan HBr, Phenylephrine HCl SYRUP ORAL 20121015 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 0067-8106_40ae8bfc-4007-4483-bb08-cf32f2e802c6 0067-8106 HUMAN OTC DRUG TRIAMINIC Night Time Cold and Cough Diphenhydramine HCl, Phenylephrine HCl SYRUP ORAL 20121015 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 0067-8114_5aa3987c-3a64-41d0-8ef0-b240aa16b18c 0067-8114 HUMAN OTC DRUG Lamisil AT for Jock Itch Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Novartis Consumer Health, Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g 0067-8115_f61a3668-1526-4124-b203-dc51bc33c201 0067-8115 HUMAN OTC DRUG Triaminic cough and sore throat Acetaminophen, Dextromethorphan HBr SUSPENSION ORAL 20140723 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 5 mg/5mL; mg/5mL 0067-8116_4e1a8f72-0ff6-4a0e-82ab-e97200ca6f28 0067-8116 HUMAN OTC DRUG Triaminic Multi-Symptom Fever and Cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20130930 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 0067-8117_0da4b415-6aaf-4c64-9c1c-f59e7edc4db2 0067-8117 HUMAN OTC DRUG Triaminic Cold and Allergy Brompheniramine maleate, Phenylephrine HCl SYRUP ORAL 20130920 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 0067-8118_85cdcb69-2336-4e36-9f24-711d391f3215 0067-8118 HUMAN OTC DRUG Triaminic Cough and Congestion Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20140620 OTC MONOGRAPH FINAL part341 Novartis Consumer Health Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 0067-8119_231eac6c-a601-4c64-b1ce-2236ba0acde6 0067-8119 HUMAN OTC DRUG Excedrin Tension Headache Pain Reliever Acetaminophen and Caffeine TABLET, FILM COATED ORAL 20140627 OTC MONOGRAPH NOT FINAL part343 Novartis Consumer Health, Inc. ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 0067-8120_1057b7ab-1304-47ea-b122-214ee0f5027d 0067-8120 HUMAN OTC DRUG Excedrin Mild Headache Caplets Acetaminophen and Caffeine TABLET, COATED ORAL 20140924 OTC MONOGRAPH NOT FINAL part343 Novartis Consumer Health, Inc. ACETAMINOPHEN; CAFFEINE 325; 65 mg/1; mg/1 0068-0007_d4068d3c-8a8e-464e-8298-99c2c38056e2 0068-0007 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 sanofi-aventis U.S. LLC DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0068-0011_d4068d3c-8a8e-464e-8298-99c2c38056e2 0068-0011 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 sanofi-aventis U.S. LLC DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0068-0015_d4068d3c-8a8e-464e-8298-99c2c38056e2 0068-0015 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 sanofi-aventis U.S. LLC DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0068-0019_d4068d3c-8a8e-464e-8298-99c2c38056e2 0068-0019 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 sanofi-aventis U.S. LLC DESIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 0068-0020_d4068d3c-8a8e-464e-8298-99c2c38056e2 0068-0020 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 sanofi-aventis U.S. LLC DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 0068-0021_d4068d3c-8a8e-464e-8298-99c2c38056e2 0068-0021 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 sanofi-aventis U.S. LLC DESIPRAMINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 0068-0037_d7ad49d4-36f7-4d14-8e13-56263a00c094 0068-0037 HUMAN PRESCRIPTION DRUG Cantil mepenzolate bromide TABLET ORAL 19561114 NDA NDA010679 sanofi-aventis U.S. LLC MEPENZOLATE BROMIDE 25 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0068-0277_e5d36c00-3c13-49cf-a507-5e748cf35682 0068-0277 HUMAN PRESCRIPTION DRUG Hiprex methenamine hippurate TABLET ORAL 19760909 NDA NDA017681 Sanofi-Aventis U.S. LLC METHENAMINE HIPPURATE 1 g/1 0068-0508_469b14ef-2403-4313-b246-f95ecb9cd3e8 0068-0508 HUMAN PRESCRIPTION DRUG Rifadin rifampin CAPSULE ORAL 19710521 NDA NDA050420 Sanofi-Aventis U.S. LLC RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 0068-0509_fd8367d6-8dbe-4b44-9f1f-90604e106884 0068-0509 HUMAN PRESCRIPTION DRUG Rifamate rifampin and isoniazid CAPSULE ORAL 19750711 ANDA ANDA061884 sanofi-aventis U.S. LLC ISONIAZID; RIFAMPIN 150; 300 mg/1; mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient],Antimycobacterial [EPC] 0068-0510_469b14ef-2403-4313-b246-f95ecb9cd3e8 0068-0510 HUMAN PRESCRIPTION DRUG Rifadin rifampin CAPSULE ORAL 19810715 ANDA ANDA062303 Sanofi-Aventis U.S. LLC RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 0068-0597_469b14ef-2403-4313-b246-f95ecb9cd3e8 0068-0597 HUMAN PRESCRIPTION DRUG Rifadin IV rifampin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19890525 NDA NDA050627 Sanofi-Aventis U.S. LLC RIFAMPIN 600 mg/10mL Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 0069-0006_259db6df-55bb-4f4b-a4fc-4670364e2bd8 0069-0006 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION INTRAVENOUS 20120203 ANDA ANDA078289 Pfizer Laboratories Div Pfizer Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 0069-0038_a67e5c6e-0b3d-444e-9ea5-316d0aa049a1 0069-0038 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION, SOLUTION INTRAVENOUS 20040729 ANDA ANDA076766 Pfizer Laboratories Div Pfizer Inc FLUCONAZOLE 200 mg/100mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0069-0043_67d1a097-8baa-40a7-9540-5e5fa5e3fe6c 0069-0043 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20110721 NDA NDA201370 Pfizer Laboratories Div Pfizer Inc HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0069-0045_a67e5c6e-0b3d-444e-9ea5-316d0aa049a1 0069-0045 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION, SOLUTION INTRAVENOUS 20040729 ANDA ANDA076766 Pfizer Laboratories Div Pfizer Inc FLUCONAZOLE 400 mg/200mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0069-0058_67d1a097-8baa-40a7-9540-5e5fa5e3fe6c 0069-0058 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20110721 NDA NDA201370 Pfizer Laboratories Div Pfizer Inc HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0069-0059_67d1a097-8baa-40a7-9540-5e5fa5e3fe6c 0069-0059 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20110721 NDA NDA201370 Pfizer Laboratories Div Pfizer Inc HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0069-0062_67d1a097-8baa-40a7-9540-5e5fa5e3fe6c 0069-0062 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20110721 NDA NDA201370 Pfizer Laboratories Div Pfizer Inc HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0069-0067_2d79aad4-1444-4d81-a7e2-f98d303cbbce 0069-0067 HUMAN PRESCRIPTION DRUG OXALIPLATIN OXALIPLATIN POWDER, FOR SOLUTION INTRAVENOUS 20120809 ANDA ANDA200979 Pfizer Laboratories Div Pfizer Inc. OXALIPLATIN 50 mg/10mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0069-0070_bcebcbab-fcb4-4f34-bf2e-e986fb321c16 0069-0070 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20120809 ANDA ANDA091358 Pfizer Laboratories Div Pfizer Inc. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0069-0074_bcebcbab-fcb4-4f34-bf2e-e986fb321c16 0069-0074 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20120809 ANDA ANDA091358 Pfizer Laboratories Div Pfizer Inc. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0069-0075_fba979ce-f5d1-4c4a-8a2f-0f170a496ec9 0069-0075 HUMAN PRESCRIPTION DRUG Topotecan Hydrochloride Topotecan Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120829 ANDA ANDA091542 Pfizer Laboratories Div Pfizer Inc. TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0069-0076_38668414-00b8-4c53-b48c-9de28ed0be5f 0069-0076 HUMAN PRESCRIPTION DRUG paclitaxel paclitaxel INJECTION INTRAVENOUS 20110930 ANDA ANDA091540 Pfizer Laboratories Div Pfizer Inc. PACLITAXEL 100 mg/16.7mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 0069-0078_38668414-00b8-4c53-b48c-9de28ed0be5f 0069-0078 HUMAN PRESCRIPTION DRUG paclitaxel paclitaxel INJECTION INTRAVENOUS 20110930 ANDA ANDA091540 Pfizer Laboratories Div Pfizer Inc. PACLITAXEL 300 mg/50mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 0069-0079_38668414-00b8-4c53-b48c-9de28ed0be5f 0069-0079 HUMAN PRESCRIPTION DRUG paclitaxel paclitaxel INJECTION INTRAVENOUS 20110930 ANDA ANDA091540 Pfizer Laboratories Div Pfizer Inc. PACLITAXEL 30 mg/5mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 0069-0080_5815a273-349f-4a9b-b6fd-af44958ba67c 0069-0080 HUMAN PRESCRIPTION DRUG Mitoxantrone Hydrochloride Mitoxantrone Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20121212 ANDA ANDA201014 Pfizer Laboratories Div Pfizer Inc. MITOXANTRONE HYDROCHLORIDE 2 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0069-0081_64db63dd-9e65-4c4e-937f-09a8ae9dcfab 0069-0081 HUMAN PRESCRIPTION DRUG Cisplatin Cisplatin INJECTION INTRAVENOUS 20120419 ANDA ANDA091062 Pfizer Laboratories Div Pfizer Inc. CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0069-0084_64db63dd-9e65-4c4e-937f-09a8ae9dcfab 0069-0084 HUMAN PRESCRIPTION DRUG Cisplatin Cisplatin INJECTION INTRAVENOUS 20120419 ANDA ANDA091062 Pfizer Laboratories Div Pfizer Inc. CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0069-0085_c6576edd-be23-40c4-bded-081f486c7605 0069-0085 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR; INTRAVENOUS 20110511 ANDA ANDA078299 Pfizer Laboratories Div Pfizer Inc KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0069-0086_5a1b9efb-8d26-43a1-909b-d59ca0dc382a 0069-0086 HUMAN PRESCRIPTION DRUG Cladribine Cladribine INJECTION INTRAVENOUS 20110710 ANDA ANDA200510 Pfizer Laboratories Div Pfizer Inc. CLADRIBINE 1 mg/mL Purine Antimetabolite [EPC] 0069-0087_c6576edd-be23-40c4-bded-081f486c7605 0069-0087 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR; INTRAVENOUS 20110511 ANDA ANDA078299 Pfizer Laboratories Div Pfizer Inc KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0069-0088_075a3185-cd77-4dbc-8058-8b478bd01879 0069-0088 HUMAN PRESCRIPTION DRUG Tobramycin Sulfate TOBRAMYCIN SULFATE INJECTION INTRAMUSCULAR; INTRAVENOUS 20110510 ANDA ANDA065407 Pfizer Laboratories Div Pfizer Inc TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0069-0091_075a3185-cd77-4dbc-8058-8b478bd01879 0069-0091 HUMAN PRESCRIPTION DRUG Tobramycin Sulfate TOBRAMYCIN SULFATE INJECTION INTRAMUSCULAR; INTRAVENOUS 20110510 ANDA ANDA065407 Pfizer Laboratories Div Pfizer Inc TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0069-0093_61554a82-303e-44d9-a02f-cfecedcacfb7 0069-0093 HUMAN PRESCRIPTION DRUG FLUMAZENIL FLUMAZENIL INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078595 Pfizer Laboratories Div Pfizer Inc FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 0069-0094_d8ba5590-0ff9-4ce2-a208-dff4b098732f 0069-0094 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110511 ANDA ANDA090243 Pfizer Laboratories Div Pfizer Inc VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0069-0099_f3bacbbc-308e-4182-9ac1-ab6e9afccfd8 0069-0099 HUMAN PRESCRIPTION DRUG Vinorelbine Vinorelbine INJECTION, SOLUTION INTRAVENOUS 20120901 ANDA ANDA200148 Pfizer Laboratories Div Pfizer Inc. VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 0069-0103_f3bacbbc-308e-4182-9ac1-ab6e9afccfd8 0069-0103 HUMAN PRESCRIPTION DRUG Vinorelbine Vinorelbine INJECTION, SOLUTION INTRAVENOUS 20120901 ANDA ANDA200148 Pfizer Laboratories Div Pfizer Inc. VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 0069-0104_3b1ff388-8f64-46b2-821c-84804ec1c72b 0069-0104 HUMAN PRESCRIPTION DRUG Doxycycline DOXYCYCLINE HYCLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120821 ANDA ANDA091406 Pfizer Laboratories Div Pfizer Inc DOXYCYCLINE HYCLATE 100 mg/10mL 0069-0105_61554a82-303e-44d9-a02f-cfecedcacfb7 0069-0105 HUMAN PRESCRIPTION DRUG FLUMAZENIL FLUMAZENIL INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078595 Pfizer Laboratories Div Pfizer Inc FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 0069-0106_eaf4cf19-3fc2-4165-a91a-56bf2fc5612d 0069-0106 HUMAN PRESCRIPTION DRUG ELELYSO Taliglucerase alfa INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120501 NDA NDA022458 Pfizer Laboratories Div Pfizer Inc TALIGLUCERASE ALFA 200 U/5mL Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC],Glucosylceramidase [Chemical/Ingredient] 0069-0107_497716fe-8f8f-4f36-b284-8490c3701abf 0069-0107 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078520 Pfizer Laboratories Div Pfizer Inc PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0069-0108_d8ba5590-0ff9-4ce2-a208-dff4b098732f 0069-0108 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110511 ANDA ANDA090243 Pfizer Laboratories Div Pfizer Inc VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0069-0109_497716fe-8f8f-4f36-b284-8490c3701abf 0069-0109 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078520 Pfizer Laboratories Div Pfizer Inc PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0069-0112_071ffdb5-425e-4cb9-8ebf-76ac94700405 0069-0112 HUMAN PRESCRIPTION DRUG Rifampin Rifampin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110510 ANDA ANDA065421 Pfizer Laboratories Div Pfizer Inc RIFAMPIN 600 mg/10mL Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 0069-0113_e0674bdd-1ce0-4c7b-a8ee-0983abb885f3 0069-0113 HUMAN PRESCRIPTION DRUG HALOPERIDOL HALOPERIDOL LACTATE INJECTION, SOLUTION INTRAMUSCULAR 20110510 ANDA ANDA078347 Pfizer Laboratories Div Pfizer Inc HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] 0069-0121_39a272d6-473a-4895-92a9-a61b5637900d 0069-0121 HUMAN PRESCRIPTION DRUG Famotidine FAMOTIDINE INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078642 Pfizer Laboratories Div Pfizer Inc FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0069-0122_28350c25-147a-48ee-bf07-eeaa57749912 0069-0122 HUMAN PRESCRIPTION DRUG Tessalon benzonatate CAPSULE ORAL 19580210 NDA NDA011210 Pfizer Laboratories BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 0069-0125_39a272d6-473a-4895-92a9-a61b5637900d 0069-0125 HUMAN PRESCRIPTION DRUG Famotidine FAMOTIDINE INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078641 Pfizer Laboratories Div Pfizer Inc FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0069-0126_39a272d6-473a-4895-92a9-a61b5637900d 0069-0126 HUMAN PRESCRIPTION DRUG Famotidine FAMOTIDINE INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078641 Pfizer Laboratories Div Pfizer Inc FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0069-0135_bfea1a92-f6f9-439d-bba2-6ed6e97532bf 0069-0135 HUMAN PRESCRIPTION DRUG BOSULIF Bosutinib monohydrate TABLET, FILM COATED ORAL 20120904 NDA NDA203341 Pfizer Laboratories Div Pfizer Inc BOSUTINIB MONOHYDRATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0069-0136_bfea1a92-f6f9-439d-bba2-6ed6e97532bf 0069-0136 HUMAN PRESCRIPTION DRUG BOSULIF Bosutinib monohydrate TABLET, FILM COATED ORAL 20120904 NDA NDA203341 Pfizer Laboratories Div Pfizer Inc BOSUTINIB MONOHYDRATE 500 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0069-0137_67d1a097-8baa-40a7-9540-5e5fa5e3fe6c 0069-0137 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20130311 NDA NDA201370 Pfizer Laboratories Div Pfizer Inc HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0069-0138_3c80c11e-30c3-4a7a-8705-a8b1b47e1377 0069-0138 HUMAN PRESCRIPTION DRUG ALSUMA sumatriptan INJECTION, SOLUTION SUBCUTANEOUS 20090831 NDA NDA022041 Pfizer Laboratories Div Pfizer Inc SUMATRIPTAN 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0069-0141_21fccf79-2ee5-4f14-b667-be38858cfb99 0069-0141 HUMAN PRESCRIPTION DRUG Rifampin RIFAMPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110510 ANDA ANDA065421 Pfizer Laboratories Div Pfizer Inc RIFAMPIN 600 mg/10mL Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 0069-0145_80b780b7-5c6b-415f-b2ef-14cbd9a22768 0069-0145 HUMAN PRESCRIPTION DRUG INLYTA axitinib TABLET, FILM COATED ORAL 20120127 NDA NDA202324 Pfizer Laboratories Div Pfizer Inc AXITINIB 1 mg/1 Kinase Inhibitor [EPC],Receptor Tyrosine Kinase Inhibitors [MoA] 0069-0146_1419b93e-84c5-4d48-a4a5-9524447280d0 0069-0146 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Pfizer Laboratories Div Pfizer Inc. METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0069-0147_1419b93e-84c5-4d48-a4a5-9524447280d0 0069-0147 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Pfizer Laboratories Div Pfizer Inc. METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0069-0148_1419b93e-84c5-4d48-a4a5-9524447280d0 0069-0148 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Pfizer Laboratories Div Pfizer Inc. METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0069-0149_93c825f1-995c-427f-b62e-f550beab61f2 0069-0149 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201530 Pfizer Laboratories Div Pfizer Inc. METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0069-0151_80b780b7-5c6b-415f-b2ef-14cbd9a22768 0069-0151 HUMAN PRESCRIPTION DRUG INLYTA axitinib TABLET, FILM COATED ORAL 20120127 NDA NDA202324 Pfizer Laboratories Div Pfizer Inc AXITINIB 5 mg/1 Kinase Inhibitor [EPC],Receptor Tyrosine Kinase Inhibitors [MoA] 0069-0152_c296d15c-df78-49e7-b55a-ff070822fdf9 0069-0152 HUMAN PRESCRIPTION DRUG Cytarabine Cytarabine INJECTION INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS 20111214 ANDA ANDA200915 Pfizer Laboratories Div Pfizer Inc. CYTARABINE 100 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0069-0153_50594983-22ae-41d5-b790-f2964b9d1560 0069-0153 HUMAN PRESCRIPTION DRUG Cytarabine Cytarabine INJECTION INTRAVENOUS; SUBCUTANEOUS 20111214 ANDA ANDA200916 Pfizer Laboratories Div Pfizer Inc. CYTARABINE 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0069-0154_161b694a-9bd5-4ef7-8524-ec9bcd366294 0069-0154 HUMAN PRESCRIPTION DRUG Cytarabine Cytarabine INJECTION INTRAVENOUS; SUBCUTANEOUS 20111214 ANDA ANDA200914 Pfizer Laboratories Div Pfizer Inc. CYTARABINE 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0069-0155_4c82b965-4389-47bf-b314-f29fbe8f5438 0069-0155 HUMAN PRESCRIPTION DRUG Cytarabine Cytarabine INJECTION INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS 20120131 ANDA ANDA201784 Pfizer Laboratories Div Pfizer Inc. CYTARABINE 2 g/20mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0069-0169_1e38c74e-af2c-4bb7-a0b6-bd646ab7d184 0069-0169 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20120718 ANDA ANDA202668 Pfizer Laboratories Div Pfizer Inc. FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0069-0170_2a0ae887-7d16-468e-b3c5-8eae3ad48828 0069-0170 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20111029 ANDA ANDA200170 Pfizer Laboratories Div Pfizer Inc. DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0069-0171_2a0ae887-7d16-468e-b3c5-8eae3ad48828 0069-0171 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20111029 ANDA ANDA200170 Pfizer Laboratories Div Pfizer Inc. DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0069-0173_1e38c74e-af2c-4bb7-a0b6-bd646ab7d184 0069-0173 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20120718 ANDA ANDA202668 Pfizer Laboratories Div Pfizer Inc. FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0069-0174_e98fc8d3-90d7-4718-90b8-b3b2cbad57c8 0069-0174 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20120718 ANDA ANDA202669 Pfizer Laboratories Div Pfizer Inc. FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0069-0176_e98fc8d3-90d7-4718-90b8-b3b2cbad57c8 0069-0176 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20120718 ANDA ANDA202669 Pfizer Laboratories Div Pfizer Inc. FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0069-0177_0c978be1-8988-47ec-b565-610ee675d53e 0069-0177 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110511 ANDA ANDA040802 Pfizer Laboratories Div Pfizer Inc DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0069-0178_0c978be1-8988-47ec-b565-610ee675d53e 0069-0178 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Pfizer Laboratories Div Pfizer Inc DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0069-0179_0c978be1-8988-47ec-b565-610ee675d53e 0069-0179 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Pfizer Laboratories Div Pfizer Inc DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0069-0181_1419b93e-84c5-4d48-a4a5-9524447280d0 0069-0181 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Pfizer Laboratories Div Pfizer Inc. METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0069-0186_b5e71e22-eb51-4442-94e0-cc2ffffbc87b 0069-0186 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078520 Pfizer Laboratories Div Pfizer Inc PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0069-0192_0c978be1-8988-47ec-b565-610ee675d53e 0069-0192 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Pfizer Laboratories Div Pfizer Inc DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0069-0201_f9732eb4-371e-4c2c-9798-8d36542ef76a 0069-0201 HUMAN PRESCRIPTION DRUG Cladribine Cladribine INJECTION INTRAVENOUS 20111007 ANDA ANDA200510 Pfizer Laboratories Div Pfizer Inc. CLADRIBINE 1 mg/mL Purine Antimetabolite [EPC] 0069-0204_72bcae83-d22e-4b5c-b61e-40b68414e2ac 0069-0204 HUMAN PRESCRIPTION DRUG Methotrexate Sodium Methotrexate Sodium INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Pfizer Laboratories Div Pfizer Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0069-0205_c2195389-bdd9-4449-963d-42b21bc7a668 0069-0205 HUMAN PRESCRIPTION DRUG Vinorelbine Vinorelbine INJECTION, SOLUTION INTRAVENOUS 20120901 ANDA ANDA200148 Pfizer Laboratories Div Pfizer Inc. VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 0069-0242_9e31c023-90f7-42b0-a4f3-1e8d0bb91c58 0069-0242 HUMAN PRESCRIPTION DRUG Toviaz fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081031 NDA NDA022030 Pfizer Laboratories Div Pfizer Inc FESOTERODINE FUMARATE 4 mg/1 0069-0244_9e31c023-90f7-42b0-a4f3-1e8d0bb91c58 0069-0244 HUMAN PRESCRIPTION DRUG Toviaz fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081031 NDA NDA022030 Pfizer Laboratories Div Pfizer Inc FESOTERODINE FUMARATE 8 mg/1 0069-0301_7ca5bb40-708c-4c5f-a3bb-ef57924a5bd6 0069-0301 HUMAN PRESCRIPTION DRUG Tobramycin Sulfate TOBRAMYCIN SULFATE INJECTION INTRAMUSCULAR; INTRAVENOUS 20110510 ANDA ANDA065407 Pfizer Laboratories Div Pfizer Inc TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0069-0302_7ca5bb40-708c-4c5f-a3bb-ef57924a5bd6 0069-0302 HUMAN PRESCRIPTION DRUG Tobramycin Sulfate TOBRAMYCIN SULFATE INJECTION INTRAMUSCULAR; INTRAVENOUS 20110510 ANDA ANDA065407 Pfizer Laboratories Div Pfizer Inc TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0069-0336_d91dbb24-097f-486b-a6d6-0adf98e74353 0069-0336 HUMAN PRESCRIPTION DRUG Revatio sildenafil citrate POWDER, FOR SUSPENSION ORAL 20140602 NDA NDA203109 Pfizer Laboratories Div Pfizer Inc SILDENAFIL CITRATE 10 mg/mL Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0069-0338_d91dbb24-097f-486b-a6d6-0adf98e74353 0069-0338 HUMAN PRESCRIPTION DRUG Revatio sildenafil citrate INJECTION, SOLUTION INTRAVENOUS 20091118 NDA NDA022473 Pfizer Laboratories Div Pfizer Inc SILDENAFIL CITRATE .8 mg/mL Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0069-0400_a3f99f4e-114c-47e4-ab48-413f25248fda 0069-0400 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19970130 NDA NDA050733 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 500 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0069-0468_3b90229e-d0cb-4a6c-8ce8-d4a0d6754b92 0069-0468 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate TABLET, FILM COATED ORAL 20060510 NDA NDA021928 Pfizer Laboratories Div Pfizer Inc VARENICLINE TARTRATE .5 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] 0069-0469_3b90229e-d0cb-4a6c-8ce8-d4a0d6754b92 0069-0469 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate TABLET, FILM COATED ORAL 20060510 NDA NDA021928 Pfizer Laboratories Div Pfizer Inc VARENICLINE TARTRATE 1 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] 0069-0471_3b90229e-d0cb-4a6c-8ce8-d4a0d6754b92 0069-0471 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate KIT 20060510 NDA NDA021928 Pfizer Laboratories Div Pfizer Inc 0069-0550_7f62bdd7-225a-4e53-8ed6-f376273c64ee 0069-0550 HUMAN PRESCRIPTION DRUG SUTENT Sunitinib malate CAPSULE ORAL 20060126 NDA NDA021938 Pfizer Laboratories Div Pfizer Inc SUNITINIB MALATE 12.5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0069-0700_2a09af01-3983-466f-8ed8-c849af848b56 0069-0700 HUMAN PRESCRIPTION DRUG Ondansetron hydrochloride and dextrose ondansetron hydrochloride and dextrose INJECTION, SOLUTION INTRAVENOUS 20090501 ANDA ANDA078308 Pfizer Labs, Division of Pfizer Inc. ONDANSETRON HYDROCHLORIDE 32 mg/50mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0069-0770_7f62bdd7-225a-4e53-8ed6-f376273c64ee 0069-0770 HUMAN PRESCRIPTION DRUG SUTENT Sunitinib malate CAPSULE ORAL 20060126 NDA NDA021938 Pfizer Laboratories Div Pfizer Inc SUNITINIB MALATE 25 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0069-0807_091ac88c-36c9-45b5-8115-934c2b0dac42 0069-0807 HUMAN PRESCRIPTION DRUG SELZENTRY Maraviroc TABLET, FILM COATED ORAL 20070806 NDA NDA022128 Pfizer Laboratories Div Pfizer Inc MARAVIROC 150 mg/1 CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] 0069-0808_091ac88c-36c9-45b5-8115-934c2b0dac42 0069-0808 HUMAN PRESCRIPTION DRUG SELZENTRY Maraviroc TABLET, FILM COATED ORAL 20070806 NDA NDA022128 Pfizer Laboratories Div Pfizer Inc MARAVIROC 300 mg/1 CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] 0069-0830_7f62bdd7-225a-4e53-8ed6-f376273c64ee 0069-0830 HUMAN PRESCRIPTION DRUG SUTENT Sunitinib malate CAPSULE ORAL 20140712 NDA NDA021938 Pfizer Laboratories Div Pfizer Inc SUNITINIB MALATE 37.5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0069-0950_ee369268-fc2e-47c2-965e-23ce43e1214e 0069-0950 HUMAN PRESCRIPTION DRUG Vibramycin Hyclate doxycycline hyclate CAPSULE ORAL 19671205 NDA NDA050007 Pfizer Laboratories Div Pfizer Inc DOXYCYCLINE HYCLATE 100 mg/1 0069-0970_ee369268-fc2e-47c2-965e-23ce43e1214e 0069-0970 HUMAN PRESCRIPTION DRUG Vibramycin Monohydrate doxycycline POWDER, FOR SUSPENSION ORAL 19671206 NDA NDA050006 Pfizer Laboratories Div Pfizer Inc DOXYCYCLINE 25 mg/5mL 0069-0971_ee369268-fc2e-47c2-965e-23ce43e1214e 0069-0971 HUMAN PRESCRIPTION DRUG Vibramycin Calcium doxycycline calcium SYRUP ORAL 19740923 NDA NDA050480 Pfizer Laboratories Div Pfizer Inc DOXYCYCLINE CALCIUM 50 mg/5mL 0069-0980_7f62bdd7-225a-4e53-8ed6-f376273c64ee 0069-0980 HUMAN PRESCRIPTION DRUG SUTENT Sunitinib malate CAPSULE ORAL 20060126 NDA NDA021938 Pfizer Laboratories Div Pfizer Inc SUNITINIB MALATE 50 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0069-0990_ee369268-fc2e-47c2-965e-23ce43e1214e 0069-0990 HUMAN PRESCRIPTION DRUG Vibra-Tabs doxycycline hyclate TABLET, FILM COATED ORAL 19800115 NDA NDA050533 Pfizer Laboratories Div Pfizer Inc DOXYCYCLINE HYCLATE 100 mg/1 0069-1001_05769384-6322-4389-bb8e-6390372bf996 0069-1001 HUMAN PRESCRIPTION DRUG XELJANZ tofacitinib TABLET, FILM COATED ORAL 20121109 NDA NDA203214 Pfizer Laboratories Div Pfizer Inc TOFACITINIB CITRATE 5 mg/1 Janus Kinase Inhibitor [EPC],Janus Kinase Inhibitors [MoA] 0069-1010_2d79aad4-1444-4d81-a7e2-f98d303cbbce 0069-1010 HUMAN PRESCRIPTION DRUG OXALIPLATIN OXALIPLATIN POWDER, FOR SOLUTION INTRAVENOUS 20120809 ANDA ANDA200979 Pfizer Laboratories Div Pfizer Inc. OXALIPLATIN 100 mg/20mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0069-1340_060b9a97-bc91-4def-ae99-ad416fdc9e35 0069-1340 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110510 ANDA ANDA078257 Pfizer Laboratories Div Pfizer Inc ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0069-1340_c54fac3e-25da-46a0-b370-e3ec49140695 0069-1340 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110510 ANDA ANDA078244 Pfizer Laboratories Div Pfizer Inc ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0069-1441_b1e53357-44a4-46cf-b0b1-7027ce1a813f 0069-1441 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20130504 ANDA ANDA090648 Pfizer Laboratories Div Pfizer Inc ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0069-1441_fb308df3-afb4-417d-9e23-334a9de862dc 0069-1441 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20130504 ANDA ANDA079224 Pfizer Laboratories Div Pfizer Inc ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0069-1520_a895f8bf-e5f2-45a4-83c1-4a5b0db3a4f9 0069-1520 HUMAN PRESCRIPTION DRUG Norvasc AMLODIPINE BESYLATE TABLET ORAL 19920731 NDA NDA019787 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0069-1530_a895f8bf-e5f2-45a4-83c1-4a5b0db3a4f9 0069-1530 HUMAN PRESCRIPTION DRUG Norvasc AMLODIPINE BESYLATE TABLET ORAL 19920731 NDA NDA019787 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0069-1540_a895f8bf-e5f2-45a4-83c1-4a5b0db3a4f9 0069-1540 HUMAN PRESCRIPTION DRUG Norvasc AMLODIPINE BESYLATE TABLET ORAL 19920731 NDA NDA019787 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0069-2150_00750590-284a-414f-9a11-bd2730d0d2ca 0069-2150 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0069-2160_00750590-284a-414f-9a11-bd2730d0d2ca 0069-2160 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0069-2170_00750590-284a-414f-9a11-bd2730d0d2ca 0069-2170 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0069-2180_00750590-284a-414f-9a11-bd2730d0d2ca 0069-2180 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0069-2190_00750590-284a-414f-9a11-bd2730d0d2ca 0069-2190 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0069-2250_00750590-284a-414f-9a11-bd2730d0d2ca 0069-2250 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0069-2260_00750590-284a-414f-9a11-bd2730d0d2ca 0069-2260 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0069-2270_00750590-284a-414f-9a11-bd2730d0d2ca 0069-2270 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0069-2390_9db2ddc3-8193-4efc-bd39-f532ccec47c5 0069-2390 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole INJECTION, SOLUTION INTRAVENOUS 20081120 ANDA ANDA078084 Pfizer Labs, Division of Pfizer Inc METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0069-2587_c1f85278-2a01-4c46-99d7-376315eba022 0069-2587 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110510 ANDA ANDA065397 Pfizer Laboratories Div Pfizer Inc VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0069-2589_c1f85278-2a01-4c46-99d7-376315eba022 0069-2589 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110510 ANDA ANDA065397 Pfizer Laboratories Div Pfizer Inc VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0069-2590_5ca413b8-c1d8-4b9a-95f6-f1410350eb2e 0069-2590 HUMAN PRESCRIPTION DRUG STERILE VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110510 ANDA ANDA065432 Pfizer Laboratories Div Pfizer Inc VANCOMYCIN HYDROCHLORIDE 5 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0069-2599_75f989f8-2943-4841-abca-37f4e0f88026 0069-2599 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110510 ANDA ANDA091469 Pfizer Laboratories Div Pfizer Inc VANCOMYCIN HYDROCHLORIDE 10 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0069-2600_bd1b5b65-6640-460b-9d5a-8b31340146ff 0069-2600 HUMAN PRESCRIPTION DRUG Procardia NIFEDIPINE CAPSULE ORAL 19811231 NDA NDA018482 Pfizer Laboratories Div Pfizer Inc NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0069-2601_53d9a66f-33f1-4670-af3b-76709840ecf9 0069-2601 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110919 ANDA ANDA091554 Pfizer Laboratories Div Pfizer Inc. VANCOMYCIN HYDROCHLORIDE 10 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0069-2650_f8eaa611-e521-4566-8d1a-f772590bac1f 0069-2650 HUMAN PRESCRIPTION DRUG Procardia XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19890906 NDA NDA019684 Pfizer Laboratories Div Pfizer Inc NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0069-2660_f8eaa611-e521-4566-8d1a-f772590bac1f 0069-2660 HUMAN PRESCRIPTION DRUG Procardia XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19890906 NDA NDA019684 Pfizer Laboratories Div Pfizer Inc NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0069-2670_f8eaa611-e521-4566-8d1a-f772590bac1f 0069-2670 HUMAN PRESCRIPTION DRUG Procardia XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19890906 NDA NDA019684 Pfizer Laboratories Div Pfizer Inc NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0069-2960_00750590-284a-414f-9a11-bd2730d0d2ca 0069-2960 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0069-2970_00750590-284a-414f-9a11-bd2730d0d2ca 0069-2970 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0069-2980_00750590-284a-414f-9a11-bd2730d0d2ca 0069-2980 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0069-3030_eacedc65-9701-4030-a558-82ad405b3178 0069-3030 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19871223 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0069-3031_eacedc65-9701-4030-a558-82ad405b3178 0069-3031 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19871223 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0069-3032_eacedc65-9701-4030-a558-82ad405b3178 0069-3032 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19871223 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0069-3033_eacedc65-9701-4030-a558-82ad405b3178 0069-3033 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19871223 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0069-3034_eacedc65-9701-4030-a558-82ad405b3178 0069-3034 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19871223 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0069-3051_8a077a18-f750-4a1b-80b8-bbf2ed387f1d 0069-3051 HUMAN PRESCRIPTION DRUG ZITHROMAX AZITHROMYCIN DIHYDRATE POWDER, FOR SUSPENSION ORAL 19940928 NDA NDA050693 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 1 g/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0069-3060_cef7a116-8e30-4dbb-ba8d-53f611f38d93 0069-3060 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate TABLET, FILM COATED ORAL 19960718 NDA NDA050711 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0069-3070_cef7a116-8e30-4dbb-ba8d-53f611f38d93 0069-3070 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate TABLET, FILM COATED ORAL 20020524 NDA NDA050784 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0069-3080_8a077a18-f750-4a1b-80b8-bbf2ed387f1d 0069-3080 HUMAN PRESCRIPTION DRUG ZITHROMAX AZITHROMYCIN DIHYDRATE TABLET, FILM COATED ORAL 19960612 NDA NDA050730 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0069-3110_cef7a116-8e30-4dbb-ba8d-53f611f38d93 0069-3110 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate POWDER, FOR SUSPENSION ORAL 19951019 NDA NDA050710 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0069-3120_cef7a116-8e30-4dbb-ba8d-53f611f38d93 0069-3120 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate POWDER, FOR SUSPENSION ORAL 19951019 NDA NDA050710 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0069-3130_cef7a116-8e30-4dbb-ba8d-53f611f38d93 0069-3130 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate POWDER, FOR SUSPENSION ORAL 19951019 NDA NDA050710 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0069-3140_cef7a116-8e30-4dbb-ba8d-53f611f38d93 0069-3140 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate POWDER, FOR SUSPENSION ORAL 19951019 NDA NDA050710 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0069-3150_071a2e0b-347d-4d7f-88c0-1b33cee1aed2 0069-3150 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19970130 NDA NDA050733 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 500 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0069-3220_83c40d73-dbdc-4f37-a006-2b164a15429a 0069-3220 HUMAN PRESCRIPTION DRUG Feldene piroxicam CAPSULE ORAL 19940525 NDA NDA018147 Pfizer Laboratories Div Pfizer Inc PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0069-3230_83c40d73-dbdc-4f37-a006-2b164a15429a 0069-3230 HUMAN PRESCRIPTION DRUG Feldene piroxicam CAPSULE ORAL 19940525 NDA NDA018147 Pfizer Laboratories Div Pfizer Inc PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0069-3241_e916bb8c-38ef-4f8c-ac32-254013339e33 0069-3241 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090911 ANDA ANDA078062 Pfizer Labs, Division of Pfizer Inc CIPROFLOXACIN 10 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0069-3342_e916bb8c-38ef-4f8c-ac32-254013339e33 0069-3342 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090911 ANDA ANDA078062 Pfizer Labs, Division of Pfizer Inc CIPROFLOXACIN 10 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0069-3857_4c567dd8-534e-49e4-9bc3-dea0aeaca2fe 0069-3857 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA200145 Pfizer Laboratories Div Pfizer Inc. GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0069-3858_4c567dd8-534e-49e4-9bc3-dea0aeaca2fe 0069-3858 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA200145 Pfizer Laboratories Div Pfizer Inc. GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0069-3859_4c567dd8-534e-49e4-9bc3-dea0aeaca2fe 0069-3859 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA200145 Pfizer Laboratories Div Pfizer Inc. GEMCITABINE HYDROCHLORIDE 2 g/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0069-4004_953f4ce5-27dc-49a0-bd57-a43f986e2cf7 0069-4004 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130317 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0069-4015_953f4ce5-27dc-49a0-bd57-a43f986e2cf7 0069-4015 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20140317 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0069-4026_953f4ce5-27dc-49a0-bd57-a43f986e2cf7 0069-4026 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20140317 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0069-4030_809ea6ab-087e-4845-88f6-edb2d9124ee2 0069-4030 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20130305 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0069-4031_809ea6ab-087e-4845-88f6-edb2d9124ee2 0069-4031 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20130305 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0069-4032_809ea6ab-087e-4845-88f6-edb2d9124ee2 0069-4032 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20130305 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0069-4033_809ea6ab-087e-4845-88f6-edb2d9124ee2 0069-4033 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20130305 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0069-4034_809ea6ab-087e-4845-88f6-edb2d9124ee2 0069-4034 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20130305 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0069-4037_953f4ce5-27dc-49a0-bd57-a43f986e2cf7 0069-4037 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20140317 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0069-4170_e1993d26-627e-441f-828f-b01d0ea9a2a7 0069-4170 HUMAN PRESCRIPTION DRUG ZMAX azithromycin dihydrate POWDER, FOR SUSPENSION ORAL 19950610 NDA NDA050797 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 2 g/60mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0069-4190_d91dbb24-097f-486b-a6d6-0adf98e74353 0069-4190 HUMAN PRESCRIPTION DRUG Revatio sildenafil citrate TABLET, FILM COATED ORAL 20050603 NDA NDA021845 Pfizer Laboratories Div Pfizer Inc SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0069-4200_bc2209af-2784-4c0b-a2f9-3cbf3e21a646 0069-4200 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Pfizer Laboratories Div Pfizer Inc SILDENAFIL CITRATE 25 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0069-4210_bc2209af-2784-4c0b-a2f9-3cbf3e21a646 0069-4210 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Pfizer Laboratories Div Pfizer Inc SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0069-4220_bc2209af-2784-4c0b-a2f9-3cbf3e21a646 0069-4220 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Pfizer Laboratories Div Pfizer Inc SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0069-4310_39ffb31d-92e3-462c-899e-527758fbf31d 0069-4310 HUMAN PRESCRIPTION DRUG Minipress prazosin hydrochloride CAPSULE ORAL 19940510 NDA NDA017442 Pfizer Laboratories Div Pfizer Inc PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0069-4370_39ffb31d-92e3-462c-899e-527758fbf31d 0069-4370 HUMAN PRESCRIPTION DRUG Minipress prazosin hydrochloride CAPSULE ORAL 19940510 NDA NDA017442 Pfizer Laboratories Div Pfizer Inc PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0069-4380_39ffb31d-92e3-462c-899e-527758fbf31d 0069-4380 HUMAN PRESCRIPTION DRUG Minipress prazosin hydrochloride CAPSULE ORAL 19940510 NDA NDA017442 Pfizer Laboratories Div Pfizer Inc PRAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0069-4395_e916bb8c-38ef-4f8c-ac32-254013339e33 0069-4395 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION INTRAVENOUS 20090911 ANDA ANDA078024 Pfizer Labs, Division of Pfizer Inc CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0069-4396_e916bb8c-38ef-4f8c-ac32-254013339e33 0069-4396 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION INTRAVENOUS 20090911 ANDA ANDA078024 Pfizer Labs, Division of Pfizer Inc CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0069-4495_4bb31494-d895-4d80-a72a-c80aff94f402 0069-4495 HUMAN PRESCRIPTION DRUG Ifosfamide Ifosfamide INJECTION, SOLUTION INTRAVENOUS 20121127 ANDA ANDA201689 Pfizer Laboratories Div Pfizer Inc. IFOSFAMIDE 50 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] 0069-4496_4bb31494-d895-4d80-a72a-c80aff94f402 0069-4496 HUMAN PRESCRIPTION DRUG Ifosfamide Ifosfamide INJECTION, SOLUTION INTRAVENOUS 20121127 ANDA ANDA201689 Pfizer Laboratories Div Pfizer Inc. IFOSFAMIDE 50 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] 0069-4541_428d765b-b52f-48f9-883c-4699a8cc6c52 0069-4541 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110511 ANDA ANDA040802 Pfizer Laboratories Div Pfizer Inc DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0069-4543_428d765b-b52f-48f9-883c-4699a8cc6c52 0069-4543 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Pfizer Laboratories Div Pfizer Inc DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0069-4545_428d765b-b52f-48f9-883c-4699a8cc6c52 0069-4545 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Pfizer Laboratories Div Pfizer Inc DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0069-4547_428d765b-b52f-48f9-883c-4699a8cc6c52 0069-4547 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Pfizer Laboratories Div Pfizer Inc DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0069-5410_7c9a39fa-a05e-4952-9f96-d7668a0cbf10 0069-5410 HUMAN PRESCRIPTION DRUG Vistaril HYDROXYZINE PAMOATE CAPSULE ORAL 19941128 NDA NDA011459 Pfizer Laboratories Div Pfizer Inc HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0069-5420_7c9a39fa-a05e-4952-9f96-d7668a0cbf10 0069-5420 HUMAN PRESCRIPTION DRUG Vistaril HYDROXYZINE PAMOATE CAPSULE ORAL 19681115 NDA NDA011459 Pfizer Laboratories Div Pfizer Inc HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0069-5800_12179284-1c75-43c4-8492-40095a66d9c0 0069-5800 HUMAN PRESCRIPTION DRUG Tikosyn dofetilide CAPSULE ORAL 19991001 NDA NDA020931 Pfizer Laboratories Div Pfizer Inc DOFETILIDE .125 mg/1 Antiarrhythmic [EPC] 0069-5810_12179284-1c75-43c4-8492-40095a66d9c0 0069-5810 HUMAN PRESCRIPTION DRUG Tikosyn dofetilide CAPSULE ORAL 19991001 NDA NDA020931 Pfizer Laboratories Div Pfizer Inc DOFETILIDE .25 mg/1 Antiarrhythmic [EPC] 0069-5820_12179284-1c75-43c4-8492-40095a66d9c0 0069-5820 HUMAN PRESCRIPTION DRUG Tikosyn dofetilide CAPSULE ORAL 19991001 NDA NDA020931 Pfizer Laboratories Div Pfizer Inc DOFETILIDE .5 mg/1 Antiarrhythmic [EPC] 0069-6001_e65bd02a-0505-437d-9bb5-915ae21a834d 0069-6001 HUMAN PRESCRIPTION DRUG CEREBYX Fosphenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131028 NDA NDA020450 Pfizer Laboratories FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0069-8140_6427427a-821b-48b4-8f06-0477f0ae4e36 0069-8140 HUMAN PRESCRIPTION DRUG Xalkori CRIZOTINIB CAPSULE ORAL 20110826 NDA NDA202570 Pfizer Laboratories Div Pfizer Inc CRIZOTINIB 250 mg/1 Kinase Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Receptor Tyrosine Kinase Inhibitors [MoA] 0069-8141_6427427a-821b-48b4-8f06-0477f0ae4e36 0069-8141 HUMAN PRESCRIPTION DRUG Xalkori CRIZOTINIB CAPSULE ORAL 20110826 NDA NDA202570 Pfizer Laboratories Div Pfizer Inc CRIZOTINIB 200 mg/1 Kinase Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Receptor Tyrosine Kinase Inhibitors [MoA] 0069-9141_89631d9b-6528-430b-832f-2ee0dec0a624 0069-9141 HUMAN PRESCRIPTION DRUG Docetaxel docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140623 NDA NDA202356 Pfizer Laboratories Div Pfizer Inc DOCETAXEL ANHYDROUS 20 mg/2mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 0069-9142_89631d9b-6528-430b-832f-2ee0dec0a624 0069-9142 HUMAN PRESCRIPTION DRUG Docetaxel docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140623 NDA NDA202356 Pfizer Laboratories Div Pfizer Inc DOCETAXEL ANHYDROUS 80 mg/8mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 0069-9144_89631d9b-6528-430b-832f-2ee0dec0a624 0069-9144 HUMAN PRESCRIPTION DRUG Docetaxel docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140623 NDA NDA202356 Pfizer Laboratories Div Pfizer Inc DOCETAXEL ANHYDROUS 200 mg/20mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 0069-9321_6d989a92-a292-4f20-bf5e-1b5b10fd9bea 0069-9321 HUMAN PRESCRIPTION DRUG Fludarabine Phosphate Fludarabine Phosphate INJECTION INTRAVENOUS 20111222 ANDA ANDA200647 Pfizer Laboratories Div Pfizer Inc. FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0071-0007_c4a08474-6528-4206-a67c-0381560e8b48 0071-0007 HUMAN PRESCRIPTION DRUG Dilantin Infatabs Phenytoin TABLET, CHEWABLE ORAL 19790226 ANDA ANDA084427 Parke-Davis Div of Pfizer Inc PHENYTOIN 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0071-0155_be9f7e70-f7af-46bc-a336-e352d20b1685 0071-0155 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Parke-Davis Div of Pfizer Inc ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0071-0156_be9f7e70-f7af-46bc-a336-e352d20b1685 0071-0156 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Parke-Davis Div of Pfizer Inc ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0071-0157_be9f7e70-f7af-46bc-a336-e352d20b1685 0071-0157 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Parke-Davis Div of Pfizer Inc ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0071-0158_be9f7e70-f7af-46bc-a336-e352d20b1685 0071-0158 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20000407 NDA NDA020702 Parke-Davis Div of Pfizer Inc ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0071-0220_5709eaad-3b5d-4d96-a20f-ad65b20b29b5 0071-0220 HUMAN PRESCRIPTION DRUG ACCURETIC quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 19991228 NDA NDA020125 Parke-Davis Div of Pfizer Inc HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0071-0222_5709eaad-3b5d-4d96-a20f-ad65b20b29b5 0071-0222 HUMAN PRESCRIPTION DRUG ACCURETIC quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 19991228 NDA NDA020125 Parke-Davis Div of Pfizer Inc HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0071-0223_5709eaad-3b5d-4d96-a20f-ad65b20b29b5 0071-0223 HUMAN PRESCRIPTION DRUG ACCURETIC quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 19991228 NDA NDA020125 Parke-Davis Div of Pfizer Inc HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0071-0237_395e8cf5-7f48-488e-97ad-7e60400aba42 0071-0237 HUMAN PRESCRIPTION DRUG Zarontin Ethosuximide CAPSULE ORAL 20000922 NDA NDA012380 Parke-Davis Div of Pfizer Inc ETHOSUXIMIDE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0071-0350_76b62e2b-a6e0-4377-8b55-2316944e3396 0071-0350 HUMAN PRESCRIPTION DRUG Nardil Phenelzine Sulfate TABLET, FILM COATED ORAL 19610609 NDA NDA011909 Parke-Davis Div of Pfizer Inc PHENELZINE SULFATE 15 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] 0071-0369_e77b90bf-2e95-423c-9438-96ff79bf4c78 0071-0369 HUMAN PRESCRIPTION DRUG Dilantin Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 19760827 ANDA ANDA084349 Parke-Davis Div of Pfizer Inc PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0071-0401_0bb1519b-7832-4dfd-a482-cd696dd660e4 0071-0401 HUMAN PRESCRIPTION DRUG Neurontin gabapentin TABLET, FILM COATED ORAL 19981009 NDA NDA020882 Parke-Davis Div of Pfizer Inc GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0071-0417_f52979cf-aa9b-444d-a942-2aef6619a4f4 0071-0417 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 Parke-Davis Div of Pfizer Inc NITROGLYCERIN .3 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0071-0418_f52979cf-aa9b-444d-a942-2aef6619a4f4 0071-0418 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 Parke-Davis Div of Pfizer Inc NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0071-0419_f52979cf-aa9b-444d-a942-2aef6619a4f4 0071-0419 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 Parke-Davis Div of Pfizer Inc NITROGLYCERIN .6 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0071-0513_0bb1519b-7832-4dfd-a482-cd696dd660e4 0071-0513 HUMAN PRESCRIPTION DRUG Neurontin gabapentin TABLET, FILM COATED ORAL 19981009 NDA NDA020882 Parke-Davis Div of Pfizer Inc GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0071-0525_fe1649b6-8f71-467b-aad4-275615657668 0071-0525 HUMAN PRESCRIPTION DRUG Celontin methsuximide CAPSULE ORAL 19570208 NDA NDA010596 Parke-Davis Div of Pfizer Inc METHSUXIMIDE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0071-0527_a96d5f95-3535-44f7-abd1-06ad8f0881a3 0071-0527 HUMAN PRESCRIPTION DRUG Accupril quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA NDA019885 Parke-Davis Div of Pfizer Inc QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0071-0530_a96d5f95-3535-44f7-abd1-06ad8f0881a3 0071-0530 HUMAN PRESCRIPTION DRUG Accupril quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA NDA019885 Parke-Davis Div of Pfizer Inc QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0071-0532_a96d5f95-3535-44f7-abd1-06ad8f0881a3 0071-0532 HUMAN PRESCRIPTION DRUG Accupril quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA NDA019885 Parke-Davis Div of Pfizer Inc QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0071-0535_a96d5f95-3535-44f7-abd1-06ad8f0881a3 0071-0535 HUMAN PRESCRIPTION DRUG Accupril quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA NDA019885 Parke-Davis Div of Pfizer Inc QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0071-0737_6cbb392d-64a2-4ccd-98e5-69f7d5da03c6 0071-0737 HUMAN PRESCRIPTION DRUG Lopid gemfibrozil TABLET, FILM COATED ORAL 20040330 NDA NDA018422 Parke-Davis Div of Pfizer Inc GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0071-0803_0bb1519b-7832-4dfd-a482-cd696dd660e4 0071-0803 HUMAN PRESCRIPTION DRUG Neurontin gabapentin CAPSULE ORAL 19931230 NDA NDA020235 Parke-Davis Div of Pfizer Inc GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0071-0805_0bb1519b-7832-4dfd-a482-cd696dd660e4 0071-0805 HUMAN PRESCRIPTION DRUG Neurontin gabapentin CAPSULE ORAL 19931230 NDA NDA020235 Parke-Davis Div of Pfizer Inc GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0071-0806_0bb1519b-7832-4dfd-a482-cd696dd660e4 0071-0806 HUMAN PRESCRIPTION DRUG Neurontin gabapentin CAPSULE ORAL 19931230 NDA NDA020235 Parke-Davis Div of Pfizer Inc GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0071-1012_acba4ee8-32fd-42e9-a2c6-6e3f28184267 0071-1012 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Parke-Davis Div of Pfizer Inc PREGABALIN 25 mg/1 CV 0071-1013_acba4ee8-32fd-42e9-a2c6-6e3f28184267 0071-1013 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Parke-Davis Div of Pfizer Inc PREGABALIN 50 mg/1 CV 0071-1014_acba4ee8-32fd-42e9-a2c6-6e3f28184267 0071-1014 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Parke-Davis Div of Pfizer Inc PREGABALIN 75 mg/1 CV 0071-1015_acba4ee8-32fd-42e9-a2c6-6e3f28184267 0071-1015 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Parke-Davis Div of Pfizer Inc PREGABALIN 100 mg/1 CV 0071-1016_acba4ee8-32fd-42e9-a2c6-6e3f28184267 0071-1016 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Parke-Davis Div of Pfizer Inc PREGABALIN 150 mg/1 CV 0071-1017_acba4ee8-32fd-42e9-a2c6-6e3f28184267 0071-1017 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Parke-Davis Div of Pfizer Inc PREGABALIN 200 mg/1 CV 0071-1018_acba4ee8-32fd-42e9-a2c6-6e3f28184267 0071-1018 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Parke-Davis Div of Pfizer Inc PREGABALIN 300 mg/1 CV 0071-1019_acba4ee8-32fd-42e9-a2c6-6e3f28184267 0071-1019 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Parke-Davis Div of Pfizer Inc PREGABALIN 225 mg/1 CV 0071-1020_acba4ee8-32fd-42e9-a2c6-6e3f28184267 0071-1020 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN SOLUTION ORAL 20041230 NDA NDA022488 Parke-Davis Div of Pfizer Inc PREGABALIN 20 mg/mL CV 0071-2012_0bb1519b-7832-4dfd-a482-cd696dd660e4 0071-2012 HUMAN PRESCRIPTION DRUG Neurontin gabapentin SOLUTION ORAL 20000302 NDA NDA021129 Parke-Davis Div of Pfizer Inc GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0071-2214_c4f8bb5c-781f-4be8-bf4d-755a2dc4bfd3 0071-2214 HUMAN PRESCRIPTION DRUG Dilantin-125 Phenytoin SUSPENSION ORAL 19530106 NDA NDA008762 Parke-Davis Div of Pfizer Inc PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0071-2418_620e03e5-28ed-423a-ae87-8ceec4f255c3 0071-2418 HUMAN PRESCRIPTION DRUG Zarontin Ethosuximide SOLUTION ORAL 20020227 ANDA ANDA080258 Parke-Davis Div of Pfizer Inc ETHOSUXIMIDE 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0071-3740_e77b90bf-2e95-423c-9438-96ff79bf4c78 0071-3740 HUMAN PRESCRIPTION DRUG Dilantin Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 19760827 ANDA ANDA084349 Parke-Davis Div of Pfizer Inc PHENYTOIN SODIUM 30 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0074-0522_67f816b1-bcb4-171d-3761-b2154995d99c 0074-0522 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20100618 NDA NDA021906 AbbVie Inc. LOPINAVIR; RITONAVIR 100; 25 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA] 0074-1040_e3fe41a1-c9f7-6c2d-5aed-0c1c41745ebb 0074-1040 HUMAN PRESCRIPTION DRUG Survanta Beractant SUSPENSION ENDOTRACHEAL 19910701 NDA NDA020032 AbbVie Inc. BERACTANT 25 mg/mL Alveolar Surface Tension Reduction [PE],Surfactant [EPC],Surfactant Activity [MoA] 0074-1052_15ffacd8-aa9d-af40-e148-645bd60cc169 0074-1052 HUMAN PRESCRIPTION DRUG Lupaneta Pack leuprolide acetate and norethindrone acetate KIT 20130701 NDA NDA203696 AbbVie Inc. 0074-1053_46caf01d-0a39-e0d4-76e9-1ce207be4ddd 0074-1053 HUMAN PRESCRIPTION DRUG Lupaneta Pack leuprolide acetate and norethindrone acetate KIT 20130701 NDA NDA203696 AbbVie Inc. 0074-1564_005c2dff-47b3-46ec-06aa-bcc5da9228b9 0074-1564 HUMAN PRESCRIPTION DRUG Depacon Valproate Sodium INJECTION INTRAVENOUS 19961230 NDA NDA020593 AbbVie Inc. VALPROATE SODIUM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0074-1658_a6ac052c-cdd6-420c-f1a6-47ada2354c1a 0074-1658 HUMAN PRESCRIPTION DRUG Zemplar Paricalcitol INJECTION, SOLUTION INTRAVENOUS 19980417 NDA NDA020819 AbbVie Inc. PARICALCITOL 5 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0074-1940_b2157f1d-6964-cd20-a05e-c3d5bb75d37d 0074-1940 HUMAN PRESCRIPTION DRUG Norvir Ritonavir SOLUTION ORAL 20100506 NDA NDA020659 AbbVie Inc. RITONAVIR 80 mg/mL HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA] 0074-2108_1b54bb3f-ed23-244b-117a-bfb8d1c769b7 0074-2108 HUMAN PRESCRIPTION DRUG Lupron Depot-PED leuprolide acetate KIT 19930416 NDA NDA020263 AbbVie Inc. 0074-2277_28cbbc67-5453-40c8-3685-b8fbbf080f21 0074-2277 HUMAN PRESCRIPTION DRUG Vicoprofen Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 19970923 NDA NDA020716 AbbVie Inc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 0074-2278_942fdd32-3f0a-14be-101d-14782bd82840 0074-2278 HUMAN PRESCRIPTION DRUG Mavik Trandolapril TABLET ORAL 19960426 NDA NDA020528 AbbVie Inc. TRANDOLAPRIL 1 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0074-2279_942fdd32-3f0a-14be-101d-14782bd82840 0074-2279 HUMAN PRESCRIPTION DRUG Mavik Trandolapril TABLET ORAL 19960426 NDA NDA020528 AbbVie Inc. TRANDOLAPRIL 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0074-2280_942fdd32-3f0a-14be-101d-14782bd82840 0074-2280 HUMAN PRESCRIPTION DRUG Mavik Trandolapril TABLET ORAL 19960426 NDA NDA020528 AbbVie Inc. TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0074-2282_1b54bb3f-ed23-244b-117a-bfb8d1c769b7 0074-2282 HUMAN PRESCRIPTION DRUG Lupron Depot-PED leuprolide acetate KIT 19930416 NDA NDA020263 AbbVie Inc. 0074-2440_1b54bb3f-ed23-244b-117a-bfb8d1c769b7 0074-2440 HUMAN PRESCRIPTION DRUG Lupron Depot-PED leuprolide acetate KIT 19930416 NDA NDA020263 AbbVie Inc. 0074-2586_69651db8-0f37-f1bc-9e3a-087494e4a977 0074-2586 HUMAN PRESCRIPTION DRUG Biaxin Clarithromycin TABLET, FILM COATED ORAL 19911031 NDA NDA050662 AbbVie Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0074-3005_dd75ea29-aa0b-2d03-0817-ada4500fe3f6 0074-3005 HUMAN PRESCRIPTION DRUG Advicor niacin and lovastatin TABLET, EXTENDED RELEASE ORAL 20011217 NDA NDA021249 AbbVie Inc. LOVASTATIN; NIACIN 20; 500 mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0074-3007_dd75ea29-aa0b-2d03-0817-ada4500fe3f6 0074-3007 HUMAN PRESCRIPTION DRUG Advicor niacin and lovastatin TABLET, EXTENDED RELEASE ORAL 20011217 NDA NDA021249 AbbVie Inc. LOVASTATIN; NIACIN 20; 1000 mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0074-3010_dd75ea29-aa0b-2d03-0817-ada4500fe3f6 0074-3010 HUMAN PRESCRIPTION DRUG Advicor niacin and lovastatin TABLET, EXTENDED RELEASE ORAL 20011217 NDA NDA021249 AbbVie Inc. LOVASTATIN; NIACIN 40; 1000 mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0074-3015_3181041b-cd07-d252-bd0d-953350a9d9ca 0074-3015 HUMAN PRESCRIPTION DRUG Teveten HCT Eprosartan Mesylate and Hydrochlorothiazide TABLET ORAL 20100524 NDA NDA021268 AbbVie Inc. EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE 600; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0074-3020_3181041b-cd07-d252-bd0d-953350a9d9ca 0074-3020 HUMAN PRESCRIPTION DRUG Teveten HCT Eprosartan Mesylate and Hydrochlorothiazide TABLET ORAL 20100524 NDA NDA021268 AbbVie Inc. EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE 600; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0074-3023_67005c9f-30e0-3f59-385c-cd4ff0cedd7c 0074-3023 HUMAN PRESCRIPTION DRUG K-Tab Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19800609 NDA NDA018279 AbbVie Inc. POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0074-3025_f3076488-3dcf-7eae-051e-090a81caa565 0074-3025 HUMAN PRESCRIPTION DRUG Teveten Eprosartan Mesylate TABLET ORAL 20100524 NDA NDA020738 AbbVie Inc. EPROSARTAN MESYLATE 400 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0074-3040_f3076488-3dcf-7eae-051e-090a81caa565 0074-3040 HUMAN PRESCRIPTION DRUG Teveten Eprosartan Mesylate TABLET ORAL 20100524 NDA NDA020738 AbbVie Inc. EPROSARTAN MESYLATE 600 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0074-3041_ab72d415-8b22-1156-7eaf-d5cdaa54bc96 0074-3041 HUMAN PRESCRIPTION DRUG Vicodin Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120910 ANDA ANDA040658 AbbVie Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0074-3043_ab72d415-8b22-1156-7eaf-d5cdaa54bc96 0074-3043 HUMAN PRESCRIPTION DRUG Vicodin ES Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120910 ANDA ANDA040556 AbbVie Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0074-3045_5be08c5b-24f9-43b0-bb9d-21b822619fd3 0074-3045 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 AbbVie Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0074-3054_ab72d415-8b22-1156-7eaf-d5cdaa54bc96 0074-3054 HUMAN PRESCRIPTION DRUG Vicodin HP Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120910 ANDA ANDA040556 AbbVie Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0074-3058_67005c9f-30e0-3f59-385c-cd4ff0cedd7c 0074-3058 HUMAN PRESCRIPTION DRUG K-Tab Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19800609 NDA NDA018279 AbbVie Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0074-3061_5be08c5b-24f9-43b0-bb9d-21b822619fd3 0074-3061 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 AbbVie Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0074-3062_5be08c5b-24f9-43b0-bb9d-21b822619fd3 0074-3062 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 AbbVie Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0074-3063_5be08c5b-24f9-43b0-bb9d-21b822619fd3 0074-3063 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 AbbVie Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0074-3064_5be08c5b-24f9-43b0-bb9d-21b822619fd3 0074-3064 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 AbbVie Inc. DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0074-3069_5be08c5b-24f9-43b0-bb9d-21b822619fd3 0074-3069 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 AbbVie Inc. DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0074-3072_dd75ea29-aa0b-2d03-0817-ada4500fe3f6 0074-3072 HUMAN PRESCRIPTION DRUG Advicor niacin and lovastatin TABLET, EXTENDED RELEASE ORAL 20011217 NDA NDA021249 AbbVie Inc. LOVASTATIN; NIACIN 20; 750 mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0074-3074_e4e7ba51-0aa5-71c4-f257-88c3f59a31ab 0074-3074 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100629 NDA NDA020381 AbbVie Inc. NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 0074-3079_e4e7ba51-0aa5-71c4-f257-88c3f59a31ab 0074-3079 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970728 NDA NDA020381 AbbVie Inc. NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 0074-3080_e4e7ba51-0aa5-71c4-f257-88c3f59a31ab 0074-3080 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970728 NDA NDA020381 AbbVie Inc. NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 0074-3093_5bc2dfb2-fc87-a863-b6df-42df2e0f7c2f 0074-3093 HUMAN PRESCRIPTION DRUG Viekira Pak Dasabuvir and Ombitasvir and Paritaprevir and Ritonavir KIT 20141219 NDA NDA206619 AbbVie Inc. 0074-3163_69651db8-0f37-f1bc-9e3a-087494e4a977 0074-3163 HUMAN PRESCRIPTION DRUG Biaxin Clarithromycin GRANULE, FOR SUSPENSION ORAL 19931223 NDA NDA050698 AbbVie Inc. CLARITHROMYCIN 125 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0074-3165_69651db8-0f37-f1bc-9e3a-087494e4a977 0074-3165 HUMAN PRESCRIPTION DRUG Biaxin Clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000303 NDA NDA050775 AbbVie Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0074-3188_69651db8-0f37-f1bc-9e3a-087494e4a977 0074-3188 HUMAN PRESCRIPTION DRUG Biaxin Clarithromycin GRANULE, FOR SUSPENSION ORAL 19931223 NDA NDA050698 AbbVie Inc. CLARITHROMYCIN 250 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0074-3197_b7168a94-a567-22b0-7ac3-60982b3a2edb 0074-3197 HUMAN PRESCRIPTION DRUG Moderiba Ribavirin TABLET, FILM COATED ORAL 20140120 ANDA ANDA077456 AbbVie Inc. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 0074-3224_b7168a94-a567-22b0-7ac3-60982b3a2edb 0074-3224 HUMAN PRESCRIPTION DRUG Moderiba Ribavirin KIT 20140120 ANDA ANDA077456 AbbVie Inc. 0074-3239_b7168a94-a567-22b0-7ac3-60982b3a2edb 0074-3239 HUMAN PRESCRIPTION DRUG Moderiba Ribavirin TABLET, FILM COATED ORAL 20140120 ANDA ANDA077456 AbbVie Inc. RIBAVIRIN 400 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 0074-3271_b7168a94-a567-22b0-7ac3-60982b3a2edb 0074-3271 HUMAN PRESCRIPTION DRUG Moderiba Ribavirin KIT 20140120 ANDA ANDA077456 AbbVie Inc. 0074-3282_b7168a94-a567-22b0-7ac3-60982b3a2edb 0074-3282 HUMAN PRESCRIPTION DRUG Moderiba Ribavirin TABLET, FILM COATED ORAL 20140120 ANDA ANDA077456 AbbVie Inc. RIBAVIRIN 600 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 0074-3287_87a5f498-a58f-deec-247d-fb4d91e5eec3 0074-3287 HUMAN PRESCRIPTION DRUG Tarka Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19961022 NDA NDA020591 AbbVie Inc. TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2; 180 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0074-3288_87a5f498-a58f-deec-247d-fb4d91e5eec3 0074-3288 HUMAN PRESCRIPTION DRUG Tarka Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19961022 NDA NDA020591 AbbVie Inc. TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 1; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0074-3289_87a5f498-a58f-deec-247d-fb4d91e5eec3 0074-3289 HUMAN PRESCRIPTION DRUG Tarka Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19961022 NDA NDA020591 AbbVie Inc. TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0074-3290_87a5f498-a58f-deec-247d-fb4d91e5eec3 0074-3290 HUMAN PRESCRIPTION DRUG Tarka Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19961022 NDA NDA020591 AbbVie Inc. TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 4; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0074-3312_2c637fa7-6e1c-ee74-199d-089e8a90b10c 0074-3312 HUMAN PRESCRIPTION DRUG Simcor Niacin and Simvastatin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080215 NDA NDA022078 AbbVie Inc. NIACIN; SIMVASTATIN 500; 20 mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0074-3315_2c637fa7-6e1c-ee74-199d-089e8a90b10c 0074-3315 HUMAN PRESCRIPTION DRUG Simcor Niacin and Simvastatin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080215 NDA NDA022078 AbbVie Inc. NIACIN; SIMVASTATIN 750; 20 mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0074-3333_b2157f1d-6964-cd20-a05e-c3d5bb75d37d 0074-3333 HUMAN PRESCRIPTION DRUG Norvir Ritonavir TABLET, FILM COATED ORAL 20100506 NDA NDA022417 AbbVie Inc. RITONAVIR 100 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA] 0074-3346_3908b94f-cd09-92d2-a1ef-d3d2774b3ffd 0074-3346 HUMAN PRESCRIPTION DRUG Lupron Depot leuprolide acetate KIT 19951222 NDA NDA020517 AbbVie Inc. 0074-3368_69651db8-0f37-f1bc-9e3a-087494e4a977 0074-3368 HUMAN PRESCRIPTION DRUG Biaxin Clarithromycin TABLET, FILM COATED ORAL 19911031 NDA NDA050662 AbbVie Inc. CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0074-3455_2c637fa7-6e1c-ee74-199d-089e8a90b10c 0074-3455 HUMAN PRESCRIPTION DRUG Simcor Niacin and Simvastatin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110127 NDA NDA022078 AbbVie Inc. NIACIN; SIMVASTATIN 1000; 20 mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0074-3457_2c637fa7-6e1c-ee74-199d-089e8a90b10c 0074-3457 HUMAN PRESCRIPTION DRUG Simcor Niacin and Simvastatin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100806 NDA NDA022078 AbbVie Inc. NIACIN; SIMVASTATIN 1000; 40 mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0074-3459_2c637fa7-6e1c-ee74-199d-089e8a90b10c 0074-3459 HUMAN PRESCRIPTION DRUG Simcor Niacin and Simvastatin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100806 NDA NDA022078 AbbVie Inc. NIACIN; SIMVASTATIN 500; 40 mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0074-3473_3908b94f-cd09-92d2-a1ef-d3d2774b3ffd 0074-3473 HUMAN PRESCRIPTION DRUG Lupron Depot leuprolide acetate KIT 19951222 NDA NDA020517 AbbVie Inc. 0074-3641_c22160df-8f23-1eac-d9a4-462a78528ae4 0074-3641 HUMAN PRESCRIPTION DRUG Lupron Depot leuprolide acetate KIT 19901022 NDA NDA020011 AbbVie Inc. 0074-3642_3908b94f-cd09-92d2-a1ef-d3d2774b3ffd 0074-3642 HUMAN PRESCRIPTION DRUG Lupron Depot leuprolide acetate KIT 19890126 NDA NDA019732 AbbVie Inc. 0074-3663_8918ce4d-b17f-7867-0e81-63404ed65513 0074-3663 HUMAN PRESCRIPTION DRUG Lupron Depot leuprolide acetate KIT 20101108 NDA NDA020708 AbbVie Inc. 0074-3683_3908b94f-cd09-92d2-a1ef-d3d2774b3ffd 0074-3683 HUMAN PRESCRIPTION DRUG Lupron Depot leuprolide acetate KIT 19951222 NDA NDA020517 AbbVie Inc. 0074-3727_7ac06272-06f4-fbf2-d038-1dd57223c961 0074-3727 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0074-3753_a587d651-288c-a08b-e786-268bce889f48 0074-3753 HUMAN PRESCRIPTION DRUG Tridione Trimethadione TABLET, CHEWABLE ORAL 19460125 NDA NDA005856 AbbVie Inc. TRIMETHADIONE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0074-3779_1b54bb3f-ed23-244b-117a-bfb8d1c769b7 0074-3779 HUMAN PRESCRIPTION DRUG Lupron Depot-PED leuprolide acetate KIT 19930416 NDA NDA020263 AbbVie Inc. 0074-3797_33edabd6-d4d6-9ee7-61eb-7cc9e3e7a5f8 0074-3797 HUMAN PRESCRIPTION DRUG Humira Adalimumab INJECTION, SOLUTION SUBCUTANEOUS 20021230 BLA BLA125057 AbbVie Inc. ADALIMUMAB 40 mg/.8mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] 0074-3799_33edabd6-d4d6-9ee7-61eb-7cc9e3e7a5f8 0074-3799 HUMAN PRESCRIPTION DRUG Humira Adalimumab KIT 20110405 BLA BLA125057 AbbVie Inc. 0074-3826_4626270f-7a41-2c3d-5ef5-74890c58c4c5 0074-3826 HUMAN PRESCRIPTION DRUG Depakote ER Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20000804 NDA NDA021168 AbbVie Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0074-3956_67f816b1-bcb4-171d-3761-b2154995d99c 0074-3956 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir SOLUTION ORAL 20100618 NDA NDA021251 AbbVie Inc. LOPINAVIR; RITONAVIR 80; 20 mg/mL; mg/mL HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA] 0074-4314_ebf66bc3-6a57-35c2-8a16-e6b284a2b05d 0074-4314 HUMAN PRESCRIPTION DRUG Zemplar Paricalcitol CAPSULE, LIQUID FILLED ORAL 20100614 NDA NDA021606 AbbVie Inc. PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0074-4315_ebf66bc3-6a57-35c2-8a16-e6b284a2b05d 0074-4315 HUMAN PRESCRIPTION DRUG Zemplar Paricalcitol CAPSULE, LIQUID FILLED ORAL 20100614 NDA NDA021606 AbbVie Inc. PARICALCITOL 4 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0074-4317_ebf66bc3-6a57-35c2-8a16-e6b284a2b05d 0074-4317 HUMAN PRESCRIPTION DRUG Zemplar Paricalcitol CAPSULE, LIQUID FILLED ORAL 20100614 NDA NDA021606 AbbVie Inc. PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0074-4339_33edabd6-d4d6-9ee7-61eb-7cc9e3e7a5f8 0074-4339 HUMAN PRESCRIPTION DRUG Humira Adalimumab KIT 20110405 BLA BLA125057 AbbVie Inc. 0074-4341_7ac06272-06f4-fbf2-d038-1dd57223c961 0074-4341 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0074-4378_d7108a58-e395-de4c-888b-feda73f63571 0074-4378 HUMAN PRESCRIPTION DRUG Nimbex Cisatracurium besylate INJECTION INTRAVENOUS 20101209 NDA NDA020551 AbbVie Inc. CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0074-4380_d7108a58-e395-de4c-888b-feda73f63571 0074-4380 HUMAN PRESCRIPTION DRUG Nimbex Cisatracurium Besylate INJECTION INTRAVENOUS 20101209 NDA NDA020551 AbbVie Inc. CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0074-4382_d7108a58-e395-de4c-888b-feda73f63571 0074-4382 HUMAN PRESCRIPTION DRUG Nimbex Cisatracurium Besylate INJECTION INTRAVENOUS 19951215 NDA NDA020551 AbbVie Inc. CISATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0074-4456_21c3defe-2a5c-8652-a385-886df473db42 0074-4456 HUMAN PRESCRIPTION DRUG Ultane Sevoflurane LIQUID RESPIRATORY (INHALATION) 19950607 NDA NDA020478 AbbVie Inc. SEVOFLURANE 250 mL/250mL General Anesthesia [PE],General Anesthetic [EPC] 0074-4456_8929502f-5ca1-1d42-17c1-39ef0f465372 0074-4456 HUMAN PRESCRIPTION DRUG Ultane Sevoflurane LIQUID RESPIRATORY (INHALATION) 19950607 NDA NDA020478 AbbVie Inc. SEVOFLURANE 250 mL/250mL General Anesthesia [PE],General Anesthetic [EPC] 0074-4552_7ac06272-06f4-fbf2-d038-1dd57223c961 0074-4552 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0074-4637_a6ac052c-cdd6-420c-f1a6-47ada2354c1a 0074-4637 HUMAN PRESCRIPTION DRUG Zemplar Paricalcitol INJECTION, SOLUTION INTRAVENOUS 19980417 NDA NDA020819 AbbVie Inc. PARICALCITOL 2 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0074-5182_7ac06272-06f4-fbf2-d038-1dd57223c961 0074-5182 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0074-5681_588b3f09-6d88-1611-6490-fddc7881692a 0074-5681 HUMAN PRESCRIPTION DRUG Depakene Valproic Acid CAPSULE, LIQUID FILLED ORAL 19780228 NDA NDA018081 AbbVie Inc. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0074-5682_588b3f09-6d88-1611-6490-fddc7881692a 0074-5682 HUMAN PRESCRIPTION DRUG Depakene Valproic Acid SOLUTION ORAL 19780228 NDA NDA018082 AbbVie Inc. VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0074-6114_086efa3f-1e63-b1d6-648d-725377ffd120 0074-6114 HUMAN PRESCRIPTION DRUG Depakote Sprinkles Divalproex Sodium CAPSULE ORAL 19890912 NDA NDA019680 AbbVie Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0074-6122_b04764d6-bddb-e056-53c5-bc9ec56eaf69 0074-6122 HUMAN PRESCRIPTION DRUG Tricor Fenofibrate TABLET ORAL 20041105 NDA NDA021656 AbbVie Inc. FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0074-6123_b04764d6-bddb-e056-53c5-bc9ec56eaf69 0074-6123 HUMAN PRESCRIPTION DRUG Tricor Fenofibrate TABLET ORAL 20041105 NDA NDA021656 AbbVie Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0074-6212_541e7221-96bb-ac2f-1715-c93e54457e40 0074-6212 HUMAN PRESCRIPTION DRUG Depakote Divalproex Sodium TABLET, DELAYED RELEASE ORAL 19830310 NDA NDA018723 AbbVie Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0074-6214_541e7221-96bb-ac2f-1715-c93e54457e40 0074-6214 HUMAN PRESCRIPTION DRUG Depakote Divalproex Sodium TABLET, DELAYED RELEASE ORAL 19830310 NDA NDA018723 AbbVie Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0074-6215_541e7221-96bb-ac2f-1715-c93e54457e40 0074-6215 HUMAN PRESCRIPTION DRUG Depakote Divalproex Sodium TABLET, DELAYED RELEASE ORAL 19830310 NDA NDA018723 AbbVie Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0074-6316_9b3590fe-1b63-4eda-89d4-6f48d31ad982 0074-6316 HUMAN PRESCRIPTION DRUG Erythrocin Stearate Erythromycin Stearate TABLET, FILM COATED ORAL 19640624 ANDA ANDA060359 AbbVie Inc. ERYTHROMYCIN STEARATE 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0074-6347_33edabd6-d4d6-9ee7-61eb-7cc9e3e7a5f8 0074-6347 HUMAN PRESCRIPTION DRUG Humira Adalimumab KIT 20140923 BLA BLA125057 AbbVie Inc. 0074-6463_0b73c86d-bfe8-8ecd-394e-fe93e017e9a4 0074-6463 HUMAN PRESCRIPTION DRUG Gengraf Cyclosporine CAPSULE ORAL 20100524 ANDA ANDA065003 AbbVie Inc. CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0074-6479_0b73c86d-bfe8-8ecd-394e-fe93e017e9a4 0074-6479 HUMAN PRESCRIPTION DRUG Gengraf Cyclosporine CAPSULE ORAL 20100524 ANDA ANDA065003 AbbVie Inc. CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0074-6594_7ac06272-06f4-fbf2-d038-1dd57223c961 0074-6594 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0074-6624_7ac06272-06f4-fbf2-d038-1dd57223c961 0074-6624 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0074-6633_648bce36-7cf3-7db8-c55c-8df73ffcc8d7 0074-6633 HUMAN PRESCRIPTION DRUG Norvir Ritonavir CAPSULE ORAL 20100506 NDA NDA020945 AbbVie Inc. RITONAVIR 100 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA] 0074-6799_67f816b1-bcb4-171d-3761-b2154995d99c 0074-6799 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20100618 NDA NDA021906 AbbVie Inc. LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA] 0074-7068_7ac06272-06f4-fbf2-d038-1dd57223c961 0074-7068 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0074-7069_7ac06272-06f4-fbf2-d038-1dd57223c961 0074-7069 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0074-7070_7ac06272-06f4-fbf2-d038-1dd57223c961 0074-7070 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0074-7126_4626270f-7a41-2c3d-5ef5-74890c58c4c5 0074-7126 HUMAN PRESCRIPTION DRUG Depakote ER Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20000804 NDA NDA021168 AbbVie Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0074-7148_7ac06272-06f4-fbf2-d038-1dd57223c961 0074-7148 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020224 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0074-7149_7ac06272-06f4-fbf2-d038-1dd57223c961 0074-7149 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 300 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0074-7269_b1dadf00-cac8-fd18-7b44-d5b34dfef186 0074-7269 HUMAN PRESCRIPTION DRUG Gengraf Cyclosporine SOLUTION ORAL 20100525 ANDA ANDA065025 AbbVie Inc. CYCLOSPORINE 100 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0074-7804_67005c9f-30e0-3f59-385c-cd4ff0cedd7c 0074-7804 HUMAN PRESCRIPTION DRUG K-Tab Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19800609 NDA NDA018279 AbbVie Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0074-8110_05ce9cea-a32f-104c-d9b9-0a94f02f2413 0074-8110 HUMAN PRESCRIPTION DRUG Calcijex Calcitriol INJECTION, SOLUTION INTRAVENOUS 20100601 NDA NDA018874 AbbVie Inc. CALCITRIOL 1 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0074-9189_a3cccbf8-be77-8e5e-bfd0-1eb98c7dec10 0074-9189 HUMAN PRESCRIPTION DRUG Trilipix Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20081215 NDA NDA022224 AbbVie Inc. FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 0074-9296_7ac06272-06f4-fbf2-d038-1dd57223c961 0074-9296 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0074-9374_33edabd6-d4d6-9ee7-61eb-7cc9e3e7a5f8 0074-9374 HUMAN PRESCRIPTION DRUG Humira Adalimumab KIT 20110405 BLA BLA125057 AbbVie Inc. 0074-9642_a3cccbf8-be77-8e5e-bfd0-1eb98c7dec10 0074-9642 HUMAN PRESCRIPTION DRUG Trilipix Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20081215 NDA NDA022224 AbbVie Inc. FENOFIBRIC ACID 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 0074-9694_1b54bb3f-ed23-244b-117a-bfb8d1c769b7 0074-9694 HUMAN PRESCRIPTION DRUG Lupron Depot-PED leuprolide acetate KIT 19930416 NDA NDA020263 AbbVie Inc. 0075-0016_594ad44c-9c5d-47ad-b596-f667476a6b2f 0075-0016 HUMAN PRESCRIPTION DRUG DDAVP Desmopressin Acetate TABLET ORAL 19950906 NDA NDA019955 sanofi-aventis U.S. LLC DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 0075-0026_594ad44c-9c5d-47ad-b596-f667476a6b2f 0075-0026 HUMAN PRESCRIPTION DRUG DDAVP Desmopressin Acetate TABLET ORAL 19950906 NDA NDA019955 sanofi-aventis U.S. LLC DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 0075-0620_2cb4222b-718d-4e8f-96ce-fc65b9a2738f 0075-0620 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20080312 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-0620_48062fc5-2c31-4d2e-9685-8ef185b56fb5 0075-0620 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-0621_2cb4222b-718d-4e8f-96ce-fc65b9a2738f 0075-0621 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20080417 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-0621_48062fc5-2c31-4d2e-9685-8ef185b56fb5 0075-0621 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-0622_2cb4222b-718d-4e8f-96ce-fc65b9a2738f 0075-0622 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20080421 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-0622_48062fc5-2c31-4d2e-9685-8ef185b56fb5 0075-0622 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-0623_2cb4222b-718d-4e8f-96ce-fc65b9a2738f 0075-0623 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20080421 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-0623_48062fc5-2c31-4d2e-9685-8ef185b56fb5 0075-0623 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-0624_2cb4222b-718d-4e8f-96ce-fc65b9a2738f 0075-0624 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20080312 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 30 mg/.3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-0624_48062fc5-2c31-4d2e-9685-8ef185b56fb5 0075-0624 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 30 mg/.3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-0626_2cb4222b-718d-4e8f-96ce-fc65b9a2738f 0075-0626 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20080421 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 300 mg/3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-0626_48062fc5-2c31-4d2e-9685-8ef185b56fb5 0075-0626 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 300 mg/3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-1506_fd9979a4-63d0-4e2c-b012-240af67540eb 0075-1506 HUMAN PRESCRIPTION DRUG NASACORT AQ triamcinolone acetonide SPRAY, METERED NASAL 19960520 NDA NDA020468 sanofi-aventis U.S. LLC TRIAMCINOLONE ACETONIDE 55 ug/1 0075-2450_b1b1e14c-afba-44c1-a384-5aae6a624046 0075-2450 HUMAN PRESCRIPTION DRUG DDAVP Rhinal Tube Desmopressin Acetate SOLUTION NASAL 19780221 NDA NDA017922 sanofi-aventis U.S. LLC DESMOPRESSIN ACETATE .1 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 0075-2451_5e30ba6d-ebb3-4950-b03a-7f1e946da982 0075-2451 HUMAN PRESCRIPTION DRUG DDAVP desmopressin acetate SOLUTION INTRAVENOUS 19840330 NDA NDA018938 sanofi-aventis U.S. LLC DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 0075-2452_517c673f-db39-4b91-bd86-eb35db5bea7f 0075-2452 HUMAN PRESCRIPTION DRUG DDAVP desmopressin acetate SOLUTION NASAL 19780221 NDA NDA017922 sanofi-aventis U.S. LLC DESMOPRESSIN ACETATE .1 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 0075-2912_2cb4222b-718d-4e8f-96ce-fc65b9a2738f 0075-2912 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20080421 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 120 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-2912_48062fc5-2c31-4d2e-9685-8ef185b56fb5 0075-2912 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 120 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-2915_2cb4222b-718d-4e8f-96ce-fc65b9a2738f 0075-2915 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20080421 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-2915_48062fc5-2c31-4d2e-9685-8ef185b56fb5 0075-2915 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-7700_3d0700b2-3cee-4276-8228-dbf608fb2612 0075-7700 HUMAN PRESCRIPTION DRUG Rilutek riluzole TABLET, FILM COATED ORAL 19951212 NDA NDA020599 sanofi-aventis U.S. LLC RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] 0075-8003_26584fe8-a8ad-45e5-8f30-268f43ef1ae5 0075-8003 HUMAN PRESCRIPTION DRUG TAXOTERE Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100802 NDA NDA020449 sanofi-aventis U.S. LLC DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 0075-8004_26584fe8-a8ad-45e5-8f30-268f43ef1ae5 0075-8004 HUMAN PRESCRIPTION DRUG TAXOTERE Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100802 NDA NDA020449 sanofi-aventis U.S. LLC DOCETAXEL 80 mg/4mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 0075-8013_df04d406-e9e4-42f7-b4a5-114811c63431 0075-8013 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 30 mg/.3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-8014_df04d406-e9e4-42f7-b4a5-114811c63431 0075-8014 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-8016_df04d406-e9e4-42f7-b4a5-114811c63431 0075-8016 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-8018_df04d406-e9e4-42f7-b4a5-114811c63431 0075-8018 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-8020_df04d406-e9e4-42f7-b4a5-114811c63431 0075-8020 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-8022_df04d406-e9e4-42f7-b4a5-114811c63431 0075-8022 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 120 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-8025_df04d406-e9e4-42f7-b4a5-114811c63431 0075-8025 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0075-8030_df04d406-e9e4-42f7-b4a5-114811c63431 0075-8030 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 300 mg/3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0076-0111_3060b295-92d1-47ad-8985-8f2ab934a3e0 0076-0111 HUMAN PRESCRIPTION DRUG URIBEL Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate CAPSULE ORAL 20100801 UNAPPROVED DRUG OTHER Star Pharmaceuticals, LLC HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .12; 120; 10; 36; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1 0076-0901_e41d0ad9-49e8-4e8a-9f8d-4b6785cc66ab 0076-0901 HUMAN PRESCRIPTION DRUG Hyophen Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate TABLET ORAL 20100921 UNAPPROVED DRUG OTHER Star Pharmaceuticals, LLC BENZOIC ACID; HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE 9; .12; 81.6; 10.8; 36.2 mg/1; mg/1; mg/1; mg/1; mg/1 Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] 0076-0902_a6d51c75-6728-4150-beba-151296950f4e 0076-0902 HUMAN PRESCRIPTION DRUG Phosphasal Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate TABLET ORAL 20100921 UNAPPROVED DRUG OTHER Star Pharmaceuticals, LLC HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .12; 81.6; 10.8; 36.2; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1 0076-0903_45e5335e-a119-4939-9d1a-28225f65f65a 0076-0903 HUMAN PRESCRIPTION DRUG Ustell Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate CAPSULE ORAL 20100927 UNAPPROVED DRUG OTHER Star Pharmaceuticals LLC HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .12; 120; 10; 36; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1 0078-0053_dd6825de-629d-4ba3-a94c-20c290b7ebe6 0078-0053 HUMAN PRESCRIPTION DRUG Methergine methylergonovine maleate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020128 20150301 NDA NDA006035 Novartis Pharmaceuticals Corporation METHYLERGONOVINE MALEATE .2 mg/mL Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 0078-0109_33a3681d-22d7-4738-93b9-eff8f9a2a6a1 0078-0109 HUMAN PRESCRIPTION DRUG Sandimmune cyclosporine INJECTION INTRAVENOUS 19831114 NDA NDA050573 Novartis Pharmaceuticals Corporation CYCLOSPORINE 50 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0078-0110_33a3681d-22d7-4738-93b9-eff8f9a2a6a1 0078-0110 HUMAN PRESCRIPTION DRUG Sandimmune cyclosporine SOLUTION ORAL 19831114 NDA NDA050574 Novartis Pharmaceuticals Corporation CYCLOSPORINE 100 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0078-0126_eefdd8e2-64b0-4e2b-a5c5-0672676521b3 0078-0126 HUMAN PRESCRIPTION DRUG Clozaril clozapine TABLET ORAL 19890930 NDA NDA019758 Novartis Pharmaceuticals Corporation CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] 0078-0127_eefdd8e2-64b0-4e2b-a5c5-0672676521b3 0078-0127 HUMAN PRESCRIPTION DRUG Clozaril clozapine TABLET ORAL 19890930 NDA NDA019758 Novartis Pharmaceuticals Corporation CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] 0078-0149_aa9d8a0e-400a-40e5-b403-a81d9c3a83bd 0078-0149 HUMAN PRESCRIPTION DRUG Miacalcin calcitonin salmon INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 19860703 NDA NDA017808 Novartis Pharmaceuticals Corporation CALCITONIN SALMON 200 [iU]/mL Calcitonin [Chemical/Ingredient],Calcitonin [EPC] 0078-0176_ee5808ab-44eb-4d3a-bbc8-c7950aca0fc6 0078-0176 HUMAN PRESCRIPTION DRUG Lescol fluvastatin sodium CAPSULE ORAL 19931230 NDA NDA020261 Novartis Pharmaceuticals Corporation FLUVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0078-0179_22b84c09-ffeb-4468-8e1a-c2c09374a89f 0078-0179 HUMAN PRESCRIPTION DRUG Lamisil terbinafine hydrochloride TABLET ORAL 19960510 NDA NDA020539 Novartis Pharmaceuticals Corporation TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 0078-0180_99b5ec1c-b6bc-4b1c-b34f-413e36d6ce8c 0078-0180 HUMAN PRESCRIPTION DRUG Sandostatin octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19881021 NDA NDA019667 Novartis Pharmaceuticals Corporation OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 0078-0181_99b5ec1c-b6bc-4b1c-b34f-413e36d6ce8c 0078-0181 HUMAN PRESCRIPTION DRUG Sandostatin octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19881021 NDA NDA019667 Novartis Pharmaceuticals Corporation OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 0078-0182_99b5ec1c-b6bc-4b1c-b34f-413e36d6ce8c 0078-0182 HUMAN PRESCRIPTION DRUG Sandostatin octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19881021 NDA NDA019667 Novartis Pharmaceuticals Corporation OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 0078-0183_99b5ec1c-b6bc-4b1c-b34f-413e36d6ce8c 0078-0183 HUMAN PRESCRIPTION DRUG Sandostatin octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19981021 NDA NDA019667 Novartis Pharmaceuticals Corporation OCTREOTIDE ACETATE 200 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 0078-0184_99b5ec1c-b6bc-4b1c-b34f-413e36d6ce8c 0078-0184 HUMAN PRESCRIPTION DRUG Sandostatin octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19881021 NDA NDA019667 Novartis Pharmaceuticals Corporation OCTREOTIDE ACETATE 1000 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 0078-0234_ee5808ab-44eb-4d3a-bbc8-c7950aca0fc6 0078-0234 HUMAN PRESCRIPTION DRUG Lescol fluvastatin sodium CAPSULE ORAL 19931230 NDA NDA020261 Novartis Pharmaceuticals Corporation FLUVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0078-0240_33a3681d-22d7-4738-93b9-eff8f9a2a6a1 0078-0240 HUMAN PRESCRIPTION DRUG Sandimmune cyclosporine CAPSULE, LIQUID FILLED ORAL 19900302 NDA NDA050625 Novartis Pharmaceuticals Corporation CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0078-0241_33a3681d-22d7-4738-93b9-eff8f9a2a6a1 0078-0241 HUMAN PRESCRIPTION DRUG Sandimmune cyclosporine CAPSULE, LIQUID FILLED ORAL 19900302 NDA NDA050625 Novartis Pharmaceuticals Corporation CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0078-0246_99f18f2d-a976-48fe-8498-b5c1baacea61 0078-0246 HUMAN PRESCRIPTION DRUG Neoral cyclosporine CAPSULE, LIQUID FILLED ORAL 19950714 NDA NDA050715 Novartis Pharmaceuticals Corporation CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0078-0248_99f18f2d-a976-48fe-8498-b5c1baacea61 0078-0248 HUMAN PRESCRIPTION DRUG Neoral cyclosporine CAPSULE, LIQUID FILLED ORAL 19950714 NDA NDA050715 Novartis Pharmaceuticals Corporation CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0078-0249_8822317c-1d65-4f19-bfa1-d7d9d5cf83e9 0078-0249 HUMAN PRESCRIPTION DRUG Femara letrozole TABLET, FILM COATED ORAL 19970731 NDA NDA020726 Novartis Pharmaceuticals Corporation LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 0078-0274_99f18f2d-a976-48fe-8498-b5c1baacea61 0078-0274 HUMAN PRESCRIPTION DRUG Neoral cyclosporine SOLUTION ORAL 19950714 NDA NDA050716 Novartis Pharmaceuticals Corporation CYCLOSPORINE 100 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0078-0311_bbd80843-5b89-4b66-b1d2-c5c5a28c346e 0078-0311 HUMAN PRESCRIPTION DRUG Miacalcin calcitonin salmon SPRAY, METERED NASAL 19950801 NDA NDA020313 Novartis Pharmaceuticals Corporation CALCITONIN SALMON 200 [iU]/1 Calcitonin [Chemical/Ingredient],Calcitonin [EPC] 0078-0314_117c8047-5ba3-4bf5-a8a1-ba4b2936098f 0078-0314 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Novartis Pharmaceuticals Corporation HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0315_117c8047-5ba3-4bf5-a8a1-ba4b2936098f 0078-0315 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Novartis Pharmaceuticals Corporation HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0323_99b816fe-30d2-4ef1-a3b5-22e24c3d2972 0078-0323 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20000430 NDA NDA020823 Novartis Pharmaceuticals Corporation RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0078-0324_99b816fe-30d2-4ef1-a3b5-22e24c3d2972 0078-0324 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20000430 NDA NDA020823 Novartis Pharmaceuticals Corporation RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0078-0325_99b816fe-30d2-4ef1-a3b5-22e24c3d2972 0078-0325 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20000430 NDA NDA020823 Novartis Pharmaceuticals Corporation RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0078-0326_99b816fe-30d2-4ef1-a3b5-22e24c3d2972 0078-0326 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20000430 NDA NDA020823 Novartis Pharmaceuticals Corporation RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0078-0327_8bf11520-4157-4708-9f78-ab62c632d799 0078-0327 HUMAN PRESCRIPTION DRUG Comtan entacapone TABLET, FILM COATED ORAL 19991019 NDA NDA020796 Novartis Pharmaceuticals Corporation ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0078-0331_88e1d8f7-be69-4d69-b417-0125a8a6b4b9 0078-0331 HUMAN PRESCRIPTION DRUG Simulect basiliximab INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19980512 BLA BLA103764 Novartis Pharmaceuticals Corporation BASILIXIMAB 20 mg/5mL Interleukin 2 Receptor Antagonists [MoA],Interleukin 2 Receptor-directed Antibody Interactions [MoA],Interleukin-2 Receptor Blocking Antibody [EPC] 0078-0337_00b78f8e-7e89-44f1-9136-62d211d37c48 0078-0337 HUMAN PRESCRIPTION DRUG Trileptal oxcarbazepine TABLET, FILM COATED ORAL 20000130 NDA NDA021014 Novartis Pharmaceuticals Corporation OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0078-0340_aab8ec14-84ee-4fd0-8be3-925bf1724ce3 0078-0340 HUMAN PRESCRIPTION DRUG Sandostatin LAR Depot octreotide acetate KIT 19881101 NDA NDA021008 Novartis Pharmaceuticals Corporation 0078-0341_aab8ec14-84ee-4fd0-8be3-925bf1724ce3 0078-0341 HUMAN PRESCRIPTION DRUG Sandostatin LAR Depot octreotide acetate KIT 19881101 NDA NDA021008 Novartis Pharmaceuticals Corporation 0078-0342_aab8ec14-84ee-4fd0-8be3-925bf1724ce3 0078-0342 HUMAN PRESCRIPTION DRUG Sandostatin LAR Depot octreotide acetate KIT 19881101 NDA NDA021008 Novartis Pharmaceuticals Corporation 0078-0343_aa024b22-8a80-4e58-b809-8cafb8c1e06e 0078-0343 HUMAN PRESCRIPTION DRUG Vivelle-Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 19990108 NDA NDA020538 Novartis Pharmaceuticals Corporation ESTRADIOL .0375 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0078-0344_aa024b22-8a80-4e58-b809-8cafb8c1e06e 0078-0344 HUMAN PRESCRIPTION DRUG Vivelle-Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 19990108 NDA NDA020538 Novartis Pharmaceuticals Corporation ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0078-0345_aa024b22-8a80-4e58-b809-8cafb8c1e06e 0078-0345 HUMAN PRESCRIPTION DRUG Vivelle-Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 19990108 NDA NDA020538 Novartis Pharmaceuticals Corporation ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0078-0346_aa024b22-8a80-4e58-b809-8cafb8c1e06e 0078-0346 HUMAN PRESCRIPTION DRUG Vivelle-Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 19990108 NDA NDA020538 Novartis Pharmaceuticals Corporation ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0078-0347_00eb6ea3-4b93-4f9d-b879-13005d59399c 0078-0347 HUMAN PRESCRIPTION DRUG Desferal deferoxamine mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19680402 NDA NDA016267 Novartis Pharmaceuticals Corporation DEFEROXAMINE MESYLATE 2000 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC] 0078-0351_66b44509-9d6c-4d67-aaec-17525b1e82c4 0078-0351 HUMAN PRESCRIPTION DRUG Starlix nateglinide TABLET ORAL 20001204 NDA NDA021204 Novartis Pharmaceuticals Corporation NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0078-0352_66b44509-9d6c-4d67-aaec-17525b1e82c4 0078-0352 HUMAN PRESCRIPTION DRUG Starlix nateglinide TABLET ORAL 20001204 NDA NDA021204 Novartis Pharmaceuticals Corporation NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0078-0354_ee5808ab-44eb-4d3a-bbc8-c7950aca0fc6 0078-0354 HUMAN PRESCRIPTION DRUG Lescol XL fluvastatin sodium TABLET, EXTENDED RELEASE ORAL 20001006 NDA NDA021192 Novartis Pharmaceuticals Corporation FLUVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0078-0357_00b78f8e-7e89-44f1-9136-62d211d37c48 0078-0357 HUMAN PRESCRIPTION DRUG Trileptal oxcarbazepine SUSPENSION ORAL 20010530 NDA NDA021285 Novartis Pharmaceuticals Corporation OXCARBAZEPINE 60 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0078-0358_bbde9c2f-044a-4d03-b04e-31805740a465 0078-0358 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Novartis Pharmaceuticals Corporation VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0078-0359_bbde9c2f-044a-4d03-b04e-31805740a465 0078-0359 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Novartis Pharmaceuticals Corporation VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0078-0360_bbde9c2f-044a-4d03-b04e-31805740a465 0078-0360 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Novartis Pharmaceuticals Corporation VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0078-0364_22b7a919-2101-4dcc-ac01-425eb9072bd7 0078-0364 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0078-0365_aa024b22-8a80-4e58-b809-8cafb8c1e06e 0078-0365 HUMAN PRESCRIPTION DRUG Vivelle-Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 19990108 NDA NDA020538 Novartis Pharmaceuticals Corporation ESTRADIOL .025 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0078-0366_ee40d8e6-2255-4f1a-b827-ffd42df97b59 0078-0366 HUMAN PRESCRIPTION DRUG Famvir famciclovir TABLET, FILM COATED ORAL 19940629 NDA NDA020363 Novartis Pharmaceuticals Corporation FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0078-0367_ee40d8e6-2255-4f1a-b827-ffd42df97b59 0078-0367 HUMAN PRESCRIPTION DRUG Famvir famciclovir TABLET, FILM COATED ORAL 19940629 NDA NDA020363 Novartis Pharmaceuticals Corporation FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0078-0368_ee40d8e6-2255-4f1a-b827-ffd42df97b59 0078-0368 HUMAN PRESCRIPTION DRUG Famvir famciclovir TABLET, FILM COATED ORAL 19940629 NDA NDA020363 Novartis Pharmaceuticals Corporation FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0078-0370_77cfa985-4cc5-495c-8961-cee6257b581e 0078-0370 HUMAN PRESCRIPTION DRUG Ritalin LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20020605 NDA NDA021284 Novartis Pharmaceuticals Corporation METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0371_77cfa985-4cc5-495c-8961-cee6257b581e 0078-0371 HUMAN PRESCRIPTION DRUG Ritalin LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20020605 NDA NDA021284 Novartis Pharmaceuticals Corporation METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0372_77cfa985-4cc5-495c-8961-cee6257b581e 0078-0372 HUMAN PRESCRIPTION DRUG Ritalin LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20020605 NDA NDA021284 Novartis Pharmaceuticals Corporation METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0377_66e77bf4-f0ed-4c88-9e6c-dffe89d90078 0078-0377 HUMAN PRESCRIPTION DRUG CombiPatch estradiol and norethindrone acetate PATCH, EXTENDED RELEASE TRANSDERMAL 19980807 NDA NDA020870 Novartis Pharmaceuticals Corporation ESTRADIOL; NORETHINDRONE ACETATE .05; .14 mg/d; mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0078-0378_66e77bf4-f0ed-4c88-9e6c-dffe89d90078 0078-0378 HUMAN PRESCRIPTION DRUG CombiPatch estradiol and norethindrone acetate PATCH, EXTENDED RELEASE TRANSDERMAL 20000101 NDA NDA020870 Novartis Pharmaceuticals Corporation ESTRADIOL; NORETHINDRONE ACETATE .05; .25 mg/d; mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0078-0379_22b7a919-2101-4dcc-ac01-425eb9072bd7 0078-0379 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0078-0380_66faca00-61f6-4bfc-8757-d5e1d6099d5d 0078-0380 HUMAN PRESCRIPTION DRUG Focalin dexmethylphenidate hydrochloride TABLET ORAL 20011130 NDA NDA021278 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0381_66faca00-61f6-4bfc-8757-d5e1d6099d5d 0078-0381 HUMAN PRESCRIPTION DRUG Focalin dexmethylphenidate hydrochloride TABLET ORAL 20011130 NDA NDA021278 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0382_66faca00-61f6-4bfc-8757-d5e1d6099d5d 0078-0382 HUMAN PRESCRIPTION DRUG Focalin dexmethylphenidate hydrochloride TABLET ORAL 20011130 NDA NDA021278 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0383_117c8047-5ba3-4bf5-a8a1-ba4b2936098f 0078-0383 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Novartis Pharmaceuticals Corporation HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0384_22b7a919-2101-4dcc-ac01-425eb9072bd7 0078-0384 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0078-0385_bb8afa5f-a96d-47b4-b4d4-317b40ea7ca9 0078-0385 HUMAN PRESCRIPTION DRUG Myfortic mycophenolic acid TABLET, DELAYED RELEASE ORAL 20040227 NDA NDA050791 Novartis Pharmaceuticals Corporation MYCOPHENOLATE SODIUM 180 mg/1 Antimetabolite Immunosuppressant [EPC] 0078-0386_bb8afa5f-a96d-47b4-b4d4-317b40ea7ca9 0078-0386 HUMAN PRESCRIPTION DRUG Myfortic mycophenolic acid TABLET, DELAYED RELEASE ORAL 20040227 NDA NDA050791 Novartis Pharmaceuticals Corporation MYCOPHENOLATE SODIUM 360 mg/1 Antimetabolite Immunosuppressant [EPC] 0078-0387_44ea8328-2d19-4291-8281-8f329b9b8ae1 0078-0387 HUMAN PRESCRIPTION DRUG Zometa zoledronic acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20010820 NDA NDA021223 Novartis Pharmaceuticals Corporation ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0078-0393_88e1d8f7-be69-4d69-b417-0125a8a6b4b9 0078-0393 HUMAN PRESCRIPTION DRUG Simulect basiliximab INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19980512 BLA BLA103764 Novartis Pharmaceuticals Corporation BASILIXIMAB 10 mg/2.5mL Interleukin 2 Receptor Antagonists [MoA],Interleukin 2 Receptor-directed Antibody Interactions [MoA],Interleukin-2 Receptor Blocking Antibody [EPC] 0078-0400_6640cc61-edee-4808-a26f-cbc2c0b7af86 0078-0400 HUMAN PRESCRIPTION DRUG Lopressor metoprolol tartrate INJECTION, SOLUTION INTRAVENOUS 19780115 NDA NDA018704 Novartis Pharmaceuticals Corporation METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0078-0401_cccd8152-9ff2-4e91-a8eb-91c0fe48c3e4 0078-0401 HUMAN PRESCRIPTION DRUG Gleevec imatinib mesylate TABLET ORAL 20010515 NDA NDA021588 Novartis Pharmaceuticals Corporation IMATINIB MESYLATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0078-0404_22b7a919-2101-4dcc-ac01-425eb9072bd7 0078-0404 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0078-0405_22b7a919-2101-4dcc-ac01-425eb9072bd7 0078-0405 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0078-0406_22b7a919-2101-4dcc-ac01-425eb9072bd7 0078-0406 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0078-0407_49247404-19d5-4cdf-83d9-58fe92fbb289 0078-0407 HUMAN PRESCRIPTION DRUG Stalevo carbidopa, levodopa, and entacapone TABLET, FILM COATED ORAL 20030611 NDA NDA021485 Novartis Pharmaceuticals Corporation CARBIDOPA; ENTACAPONE; LEVODOPA 12.5; 200; 50 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0078-0408_49247404-19d5-4cdf-83d9-58fe92fbb289 0078-0408 HUMAN PRESCRIPTION DRUG Stalevo carbidopa, levodopa, and entacapone TABLET, FILM COATED ORAL 20030611 NDA NDA021485 Novartis Pharmaceuticals Corporation CARBIDOPA; ENTACAPONE; LEVODOPA 25; 200; 100 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0078-0409_49247404-19d5-4cdf-83d9-58fe92fbb289 0078-0409 HUMAN PRESCRIPTION DRUG Stalevo carbidopa, levodopa, and entacapone TABLET, FILM COATED ORAL 20030611 NDA NDA021485 Novartis Pharmaceuticals Corporation CARBIDOPA; ENTACAPONE; LEVODOPA 37.5; 200; 150 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0078-0414_007c5b4e-7e8d-40b2-8d4f-02512e88d8ac 0078-0414 HUMAN PRESCRIPTION DRUG Zortress everolimus TABLET ORAL 20100422 NDA NDA021560 Novartis Pharmaceuticals Corporation EVEROLIMUS .5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0078-0415_007c5b4e-7e8d-40b2-8d4f-02512e88d8ac 0078-0415 HUMAN PRESCRIPTION DRUG Zortress everolimus TABLET ORAL 20100422 NDA NDA021560 Novartis Pharmaceuticals Corporation EVEROLIMUS .75 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0078-0417_007c5b4e-7e8d-40b2-8d4f-02512e88d8ac 0078-0417 HUMAN PRESCRIPTION DRUG Zortress everolimus TABLET ORAL 20100422 NDA NDA021560 Novartis Pharmaceuticals Corporation EVEROLIMUS .25 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0078-0423_bbde9c2f-044a-4d03-b04e-31805740a465 0078-0423 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Novartis Pharmaceuticals Corporation VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0078-0424_77cfa985-4cc5-495c-8961-cee6257b581e 0078-0424 HUMAN PRESCRIPTION DRUG Ritalin LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20020605 NDA NDA021284 Novartis Pharmaceuticals Corporation METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0425_d84efbd9-c39a-3c0a-5918-2ed77f5cf4fb 0078-0425 HUMAN OTC DRUG GenTeal Moderate to Severe hypromelloses and carboxymethylcellulose sodium GEL OPHTHALMIC 20090914 OTC MONOGRAPH FINAL part349 Novartis Pharmaceutical Corporation CARBOXYMETHYLCELLULOSE SODIUM; HYPROMELLOSES 2.5; 3 mg/mL; mg/mL 0078-0429_77126265-7983-4c3b-b172-73149a7a9890 0078-0429 HUMAN OTC DRUG GenTeal Severe HYPROMELLOSE GEL OPHTHALMIC 20090914 OTC MONOGRAPH FINAL part349 Novartis Pharmaceuticals Corporation HYPROMELLOSE 2910 (4000 MPA.S) .003 g/g 0078-0430_bb7f8a24-7c97-4537-9901-3c6ea16b4893 0078-0430 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0431_bb7f8a24-7c97-4537-9901-3c6ea16b4893 0078-0431 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0432_bb7f8a24-7c97-4537-9901-3c6ea16b4893 0078-0432 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0433_bb7f8a24-7c97-4537-9901-3c6ea16b4893 0078-0433 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0434_bb7f8a24-7c97-4537-9901-3c6ea16b4893 0078-0434 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0435_88545612-28d8-4d6e-a10b-a9cfaba778d0 0078-0435 HUMAN PRESCRIPTION DRUG Reclast zoledronic acid INJECTION, SOLUTION INTRAVENOUS 20070401 NDA NDA021817 Novartis Pharmaceuticals Corporation ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0078-0436_cc6c7862-52fd-4ddd-a61d-2699517f9f1b 0078-0436 HUMAN PRESCRIPTION DRUG Cataflam diclofenac potassium TABLET, SUGAR COATED ORAL 19931124 NDA NDA020142 Novartis Pharmaceuticals Corporation DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0078-0438_cccd8152-9ff2-4e91-a8eb-91c0fe48c3e4 0078-0438 HUMAN PRESCRIPTION DRUG Gleevec imatinib mesylate TABLET ORAL 20010515 NDA NDA021588 Novartis Pharmaceuticals Corporation IMATINIB MESYLATE 400 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0078-0439_ff8b29b0-ba85-43b9-a54b-ec0e3544b73f 0078-0439 HUMAN PRESCRIPTION DRUG Ritalin methylphenidate hydrochloride TABLET ORAL 19551231 NDA NDA010187 Novartis Pharmaceuticals Corporation METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0440_ff8b29b0-ba85-43b9-a54b-ec0e3544b73f 0078-0440 HUMAN PRESCRIPTION DRUG Ritalin methylphenidate hydrochloride TABLET ORAL 19551231 NDA NDA010187 Novartis Pharmaceuticals Corporation METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0441_ff8b29b0-ba85-43b9-a54b-ec0e3544b73f 0078-0441 HUMAN PRESCRIPTION DRUG Ritalin methylphenidate hydrochloride TABLET ORAL 19551231 NDA NDA010187 Novartis Pharmaceuticals Corporation METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0442_ff8b29b0-ba85-43b9-a54b-ec0e3544b73f 0078-0442 HUMAN PRESCRIPTION DRUG Ritalin SR methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 19820331 NDA NDA018029 Novartis Pharmaceuticals Corporation METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0446_bd95d8d8-0041-4bec-9f63-18039b1404d8 0078-0446 HUMAN PRESCRIPTION DRUG Voltaren XR diclofenac sodium extended release tablets TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960308 NDA NDA020254 Novartis Pharmaceuticals Corporation DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0078-0449_889ad719-16c0-464b-8f25-61cf7a3a2381 0078-0449 HUMAN PRESCRIPTION DRUG Lotensin Benazepril Hydrochloride TABLET ORAL 19910625 20160201 NDA NDA019851 Novartis Pharmaceuticals Corporation BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0078-0450_889ad719-16c0-464b-8f25-61cf7a3a2381 0078-0450 HUMAN PRESCRIPTION DRUG Lotensin Benazepril Hydrochloride TABLET ORAL 19910625 20160101 NDA NDA019851 Novartis Pharmaceuticals Corporation BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0078-0453_ee6593b0-c2d7-46af-83b6-95cde9aff6f8 0078-0453 HUMAN PRESCRIPTION DRUG Lotensin HCT benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 19920530 20150930 NDA NDA020033 Novartis Pharmaceuticals Corporation BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0456_00b78f8e-7e89-44f1-9136-62d211d37c48 0078-0456 HUMAN PRESCRIPTION DRUG Trileptal oxcarbazepine TABLET, FILM COATED ORAL 20000130 NDA NDA021014 Novartis Pharmaceuticals Corporation OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0078-0457_00b78f8e-7e89-44f1-9136-62d211d37c48 0078-0457 HUMAN PRESCRIPTION DRUG Trileptal oxcarbazepine TABLET, FILM COATED ORAL 20000130 NDA NDA021014 Novartis Pharmaceuticals Corporation OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0078-0458_00557380-0ab6-49a7-8101-0c8ae2a31fec 0078-0458 HUMAN PRESCRIPTION DRUG Lopressor metoprolol tartrate TABLET ORAL 19780115 20160831 NDA NDA017963 Novartis Pharmaceuticals Corporation METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0078-0459_00557380-0ab6-49a7-8101-0c8ae2a31fec 0078-0459 HUMAN PRESCRIPTION DRUG Lopressor metoprolol tartrate TABLET ORAL 19780115 20160930 NDA NDA017963 Novartis Pharmaceuticals Corporation METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0078-0467_00eb6ea3-4b93-4f9d-b879-13005d59399c 0078-0467 HUMAN PRESCRIPTION DRUG Desferal deferoxamine mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19680402 NDA NDA016267 Novartis Pharmaceuticals Corporation DEFEROXAMINE MESYLATE 500 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC] 0078-0468_88d7f743-652b-4b3e-9cbc-8366ab3c36e3 0078-0468 HUMAN PRESCRIPTION DRUG Exjade deferasirox TABLET, FOR SUSPENSION ORAL 20051130 NDA NDA021882 Novartis Pharmaceuticals Corporation DEFERASIROX 125 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA] 0078-0469_88d7f743-652b-4b3e-9cbc-8366ab3c36e3 0078-0469 HUMAN PRESCRIPTION DRUG Exjade deferasirox TABLET, FOR SUSPENSION ORAL 20051130 NDA NDA021882 Novartis Pharmaceuticals Corporation DEFERASIROX 250 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA] 0078-0470_88d7f743-652b-4b3e-9cbc-8366ab3c36e3 0078-0470 HUMAN PRESCRIPTION DRUG Exjade deferasirox TABLET, FOR SUSPENSION ORAL 20051130 NDA NDA021882 Novartis Pharmaceuticals Corporation DEFERASIROX 500 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA] 0078-0471_117c8047-5ba3-4bf5-a8a1-ba4b2936098f 0078-0471 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20060428 NDA NDA020818 Novartis Pharmaceuticals Corporation HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0472_117c8047-5ba3-4bf5-a8a1-ba4b2936098f 0078-0472 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20060428 NDA NDA020818 Novartis Pharmaceuticals Corporation HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0473_7998f93b-a4f2-7fdf-f9fd-621d3bc53b72 0078-0473 HUMAN OTC DRUG GenTeal Night-time PM white petrolatum OINTMENT OPHTHALMIC 20091214 OTC MONOGRAPH FINAL part349 Novartis Pharmaceutical Corporation MINERAL OIL; PETROLATUM .15; .85 g/g; g/g 0078-0476_8a8ae065-07da-4e38-b9d8-9a6937f94f58 0078-0476 HUMAN OTC DRUG Zaditor Antihistamine Eye Drops Ketotifen Fumarate SOLUTION OPHTHALMIC 20090922 NDA NDA021066 Novartis Pharmaceuticals Corporation KETOTIFEN FUMARATE .345 mg/mL 0078-0478_6c5976d5-702b-25d9-18a2-edeffd8df30c 0078-0478 HUMAN PRESCRIPTION DRUG VOLTAREN diclofenac sodium SOLUTION OPHTHALMIC 19910328 NDA NDA020037 Novartis Pharmaceutical Corporation DICLOFENAC SODIUM 1 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0078-0485_dd1fca65-98f3-4cb3-a0bf-2c4fe90bdf88 0078-0485 HUMAN PRESCRIPTION DRUG Tekturna aliskiren hemifumarate TABLET, FILM COATED ORAL 20070305 NDA NDA021985 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE 150 mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA] 0078-0486_dd1fca65-98f3-4cb3-a0bf-2c4fe90bdf88 0078-0486 HUMAN PRESCRIPTION DRUG Tekturna aliskiren hemifumarate TABLET, FILM COATED ORAL 20070305 NDA NDA021985 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE 300 mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA] 0078-0488_ee603c1f-4332-4247-9b37-ff281605fbf2 0078-0488 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20070620 NDA NDA021990 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0078-0489_ee603c1f-4332-4247-9b37-ff281605fbf2 0078-0489 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20070620 NDA NDA021990 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; VALSARTAN 10; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0078-0490_ee603c1f-4332-4247-9b37-ff281605fbf2 0078-0490 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20070620 NDA NDA021990 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0078-0491_ee603c1f-4332-4247-9b37-ff281605fbf2 0078-0491 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20070620 NDA NDA021990 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0078-0492_55ddc863-9ab4-4a60-aaea-8ebdb0d54aed 0078-0492 HUMAN PRESCRIPTION DRUG Tegretol carbamazepine TABLET, CHEWABLE ORAL 19811214 NDA NDA018281 Novartis Pharmaceuticals Corporation CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0078-0493_bb7f8a24-7c97-4537-9901-3c6ea16b4893 0078-0493 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0494_9903a3d0-6f8d-4881-aead-8c5ce55da18b 0078-0494 HUMAN PRESCRIPTION DRUG TOBI Tobramycin SOLUTION ORAL 19971222 NDA NDA050753 Novartis Pharmaceuticals Corporation TOBRAMYCIN 300 mg/5mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0078-0495_d7232a34-b86b-47f3-b921-13a27fdf93a6 0078-0495 HUMAN PRESCRIPTION DRUG PROLEUKIN Aldesleukin INJECTION INTRAVENOUS 19920506 BLA BLA103293 Novartis Pharmaceuticals Corporation ALDESLEUKIN 1.1 mg/mL Increased Lymphocyte Activation [PE],Increased Lymphocyte Cell Production [PE],Interleukin-2 [Chemical/Ingredient],Lymphocyte Growth Factor [EPC] 0078-0499_009b4cf5-3c26-4ddb-97a4-e6b8297939c7 0078-0499 HUMAN PRESCRIPTION DRUG Lamisil terbinafine hydrochloride GRANULE ORAL 20070928 NDA NDA022071 Novartis Pharmaceuticals Corporation TERBINAFINE HYDROCHLORIDE 125 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 0078-0500_009b4cf5-3c26-4ddb-97a4-e6b8297939c7 0078-0500 HUMAN PRESCRIPTION DRUG Lamisil terbinafine hydrochloride GRANULE ORAL 20070928 NDA NDA022071 Novartis Pharmaceuticals Corporation TERBINAFINE HYDROCHLORIDE 187.5 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 0078-0501_33ec21a9-1f45-4c1a-8a6e-1107766ccfea 0078-0501 HUMAN PRESCRIPTION DRUG Exelon rivastigmine PATCH, EXTENDED RELEASE TRANSDERMAL 20070706 NDA NDA022083 Novartis Pharmaceuticals Corporation RIVASTIGMINE 4.6 mg/24h Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0078-0502_33ec21a9-1f45-4c1a-8a6e-1107766ccfea 0078-0502 HUMAN PRESCRIPTION DRUG Exelon rivastigmine PATCH, EXTENDED RELEASE TRANSDERMAL 20070706 NDA NDA022083 Novartis Pharmaceuticals Corporation RIVASTIGMINE 9.5 mg/24h Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0078-0503_33ec21a9-1f45-4c1a-8a6e-1107766ccfea 0078-0503 HUMAN PRESCRIPTION DRUG Exelon rivastigmine PATCH, EXTENDED RELEASE TRANSDERMAL 20070706 NDA NDA022083 Novartis Pharmaceuticals Corporation RIVASTIGMINE 13.3 mg/24h Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0078-0508_55ddc863-9ab4-4a60-aaea-8ebdb0d54aed 0078-0508 HUMAN PRESCRIPTION DRUG Tegretol carbamazepine SUSPENSION ORAL 19871218 NDA NDA018927 Novartis Pharmaceuticals Corporation CARBAMAZEPINE 100 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0078-0509_55ddc863-9ab4-4a60-aaea-8ebdb0d54aed 0078-0509 HUMAN PRESCRIPTION DRUG Tegretol carbamazepine TABLET ORAL 19680311 NDA NDA016608 Novartis Pharmaceuticals Corporation CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0078-0510_55ddc863-9ab4-4a60-aaea-8ebdb0d54aed 0078-0510 HUMAN PRESCRIPTION DRUG Tegretol XR carbamazepine TABLET, EXTENDED RELEASE ORAL 19960325 NDA NDA020234 Novartis Pharmaceuticals Corporation CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0078-0511_55ddc863-9ab4-4a60-aaea-8ebdb0d54aed 0078-0511 HUMAN PRESCRIPTION DRUG Tegretol XR carbamazepine TABLET, EXTENDED RELEASE ORAL 19960325 NDA NDA020234 Novartis Pharmaceuticals Corporation CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0078-0512_55ddc863-9ab4-4a60-aaea-8ebdb0d54aed 0078-0512 HUMAN PRESCRIPTION DRUG Tegretol XR carbamazepine TABLET, EXTENDED RELEASE ORAL 19960325 NDA NDA020234 Novartis Pharmaceuticals Corporation CARBAMAZEPINE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0078-0517_10686b14-888b-f19a-cbc0-8f9b59264689 0078-0517 HUMAN OTC DRUG GenTeal Mild hypromellose LIQUID OPHTHALMIC 20090914 OTC MONOGRAPH FINAL part349 Novartis Pharmaceutical Corporation HYPROMELLOSE 2910 (4000 MPA.S) .002 L/L 0078-0518_f9a7c50d-feb8-375d-cc86-1a779df24eea 0078-0518 HUMAN OTC DRUG GenTeal Mild to Moderate hypromellose LIQUID OPHTHALMIC 20090914 OTC MONOGRAPH FINAL part349 Novartis Pharmaceutical Corporation HYPROMELLOSE 2910 (4000 MPA.S) .003 L/L 0078-0519_1f11fbef-9c86-c646-a1f9-cdff7fea102f 0078-0519 HUMAN OTC DRUG HypoTears polyvinyl alcohol and polyehtylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20050701 OTC MONOGRAPH FINAL part349 Novartis Pharmaceutical Corporation POLYETHYLENE GLYCOL 400; POLYVINYL ALCOHOL 10; 10 mg/mL; mg/mL 0078-0521_aa9647cd-46f9-415b-aa82-0a642e6f27b2 0078-0521 HUMAN PRESCRIPTION DRUG Tekturna HCT aliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20080801 NDA NDA022107 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Renin Inhibitor [EPC],Renin Inhibitors [MoA] 0078-0522_aa9647cd-46f9-415b-aa82-0a642e6f27b2 0078-0522 HUMAN PRESCRIPTION DRUG Tekturna HCT aliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20080801 NDA NDA022107 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE 150; 25 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0523_aa9647cd-46f9-415b-aa82-0a642e6f27b2 0078-0523 HUMAN PRESCRIPTION DRUG Tekturna HCT aliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20080801 NDA NDA022107 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0524_aa9647cd-46f9-415b-aa82-0a642e6f27b2 0078-0524 HUMAN PRESCRIPTION DRUG Tekturna HCT aliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20080801 NDA NDA022107 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE 300; 25 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0526_99822abb-0c62-4d42-bb4a-1c749d8a3cd7 0078-0526 HUMAN PRESCRIPTION DRUG Tasigna nilotinib CAPSULE ORAL 20071029 NDA NDA022068 Novartis Pharmaceuticals Corporation NILOTINIB 200 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0078-0527_49247404-19d5-4cdf-83d9-58fe92fbb289 0078-0527 HUMAN PRESCRIPTION DRUG Stalevo carbidopa, levodopa, and entacapone TABLET, FILM COATED ORAL 20070802 NDA NDA021485 Novartis Pharmaceuticals Corporation CARBIDOPA; ENTACAPONE; LEVODOPA 50; 200; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0078-0538_ffdc0d21-6d1f-46e0-826f-bb0e7de4afad 0078-0538 HUMAN PRESCRIPTION DRUG Tyzeka telbivudine TABLET, FILM COATED ORAL 20061025 NDA NDA022011 Novartis Pharmaceuticals Corporation TELBIVUDINE 600 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0078-0539_ffdc0d21-6d1f-46e0-826f-bb0e7de4afad 0078-0539 HUMAN PRESCRIPTION DRUG Tyzeka telbivudine SOLUTION ORAL 20090428 NDA NDA022154 Novartis Pharmaceuticals Corporation TELBIVUDINE 20 mg/mL Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0078-0544_49247404-19d5-4cdf-83d9-58fe92fbb289 0078-0544 HUMAN PRESCRIPTION DRUG Stalevo carbidopa, levodopa, and entacapone TABLET, FILM COATED ORAL 20080926 NDA NDA021485 Novartis Pharmaceuticals Corporation CARBIDOPA; ENTACAPONE; LEVODOPA 18.75; 200; 75 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0078-0545_49247404-19d5-4cdf-83d9-58fe92fbb289 0078-0545 HUMAN PRESCRIPTION DRUG Stalevo carbidopa, levodopa, and entacapone TABLET, FILM COATED ORAL 20080926 NDA NDA021485 Novartis Pharmaceuticals Corporation CARBIDOPA; ENTACAPONE; LEVODOPA 31.25; 200; 125 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0078-0559_ddf43891-ec9d-4051-80cf-edca5525bad6 0078-0559 HUMAN PRESCRIPTION DRUG Exforge HCT amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20090404 NDA NDA022314 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5; 12.5; 160 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0560_ddf43891-ec9d-4051-80cf-edca5525bad6 0078-0560 HUMAN PRESCRIPTION DRUG Exforge HCT amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20090404 NDA NDA022314 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5; 25; 160 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0561_ddf43891-ec9d-4051-80cf-edca5525bad6 0078-0561 HUMAN PRESCRIPTION DRUG Exforge HCT amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20090404 NDA NDA022314 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10; 12.5; 160 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0562_ddf43891-ec9d-4051-80cf-edca5525bad6 0078-0562 HUMAN PRESCRIPTION DRUG Exforge HCT amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20090404 NDA NDA022314 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10; 25; 160 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0563_ddf43891-ec9d-4051-80cf-edca5525bad6 0078-0563 HUMAN PRESCRIPTION DRUG Exforge HCT amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20090404 NDA NDA022314 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10; 25; 320 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0566_ee8b355a-e598-4c57-a1d0-ba96ce5f0155 0078-0566 HUMAN PRESCRIPTION DRUG Afinitor everolimus TABLET ORAL 20090331 NDA NDA022334 Novartis Pharmaceuticals Corporation EVEROLIMUS 5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0078-0567_ee8b355a-e598-4c57-a1d0-ba96ce5f0155 0078-0567 HUMAN PRESCRIPTION DRUG Afinitor everolimus TABLET ORAL 20090331 NDA NDA022334 Novartis Pharmaceuticals Corporation EVEROLIMUS 10 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0078-0568_22e08d44-21dd-4ee7-a974-d82da2626c40 0078-0568 HUMAN PRESCRIPTION DRUG COARTEM artemether and lumefantrine TABLET ORAL 20090407 NDA NDA022268 Novartis Pharmaceuticals Corporation ARTEMETHER; LUMEFANTRINE 20; 120 mg/1; mg/1 Antimalarial [EPC],Antimalarial [EPC] 0078-0569_22dbd9a5-52d5-452b-b764-772f25152591 0078-0569 HUMAN PRESCRIPTION DRUG EXTAVIA Interferon beta-1b KIT 20090814 BLA BLA125290 Novartis Pharmaceuticals Corporation 0078-0582_2219199a-37bc-4936-9237-558a4475d00f 0078-0582 HUMAN PRESCRIPTION DRUG Ilaris canakinumab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20090618 BLA BLA125319 Novartis Pharmaceuticals Corporation CANAKINUMAB 150 mg/mL 0078-0590_44ea8328-2d19-4291-8281-8f329b9b8ae1 0078-0590 HUMAN PRESCRIPTION DRUG Zometa zoledronic acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20010820 NDA NDA021223 Novartis Pharmaceuticals Corporation ZOLEDRONIC ACID 4 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0078-0592_99822abb-0c62-4d42-bb4a-1c749d8a3cd7 0078-0592 HUMAN PRESCRIPTION DRUG Tasigna nilotinib CAPSULE ORAL 20071029 NDA NDA022068 Novartis Pharmaceuticals Corporation NILOTINIB 150 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0078-0594_ee8b355a-e598-4c57-a1d0-ba96ce5f0155 0078-0594 HUMAN PRESCRIPTION DRUG Afinitor everolimus TABLET ORAL 20100709 NDA NDA022334 Novartis Pharmaceuticals Corporation EVEROLIMUS 2.5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0078-0595_22ae60cc-b992-4b87-8e70-c217ce57cd0c 0078-0595 HUMAN PRESCRIPTION DRUG FANAPT Iloperidone TABLET ORAL 20091001 NDA NDA022192 Novartis Pharmaceuticals Corporation ILOPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 0078-0596_22ae60cc-b992-4b87-8e70-c217ce57cd0c 0078-0596 HUMAN PRESCRIPTION DRUG FANAPT Iloperidone TABLET ORAL 20091001 NDA NDA022192 Novartis Pharmaceuticals Corporation ILOPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 0078-0597_22ae60cc-b992-4b87-8e70-c217ce57cd0c 0078-0597 HUMAN PRESCRIPTION DRUG FANAPT Iloperidone TABLET ORAL 20091001 NDA NDA022192 Novartis Pharmaceuticals Corporation ILOPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 0078-0598_22ae60cc-b992-4b87-8e70-c217ce57cd0c 0078-0598 HUMAN PRESCRIPTION DRUG FANAPT Iloperidone TABLET ORAL 20091001 NDA NDA022192 Novartis Pharmaceuticals Corporation ILOPERIDONE 6 mg/1 Atypical Antipsychotic [EPC] 0078-0599_22ae60cc-b992-4b87-8e70-c217ce57cd0c 0078-0599 HUMAN PRESCRIPTION DRUG FANAPT Iloperidone TABLET ORAL 20091001 NDA NDA022192 Novartis Pharmaceuticals Corporation ILOPERIDONE 8 mg/1 Atypical Antipsychotic [EPC] 0078-0600_22ae60cc-b992-4b87-8e70-c217ce57cd0c 0078-0600 HUMAN PRESCRIPTION DRUG FANAPT Iloperidone TABLET ORAL 20091001 NDA NDA022192 Novartis Pharmaceuticals Corporation ILOPERIDONE 10 mg/1 Atypical Antipsychotic [EPC] 0078-0601_22ae60cc-b992-4b87-8e70-c217ce57cd0c 0078-0601 HUMAN PRESCRIPTION DRUG FANAPT Iloperidone TABLET ORAL 20091001 NDA NDA022192 Novartis Pharmaceuticals Corporation ILOPERIDONE 12 mg/1 Atypical Antipsychotic [EPC] 0078-0602_22ae60cc-b992-4b87-8e70-c217ce57cd0c 0078-0602 HUMAN PRESCRIPTION DRUG FANAPT Iloperidone KIT ORAL 20091001 NDA NDA022192 Novartis Pharmaceuticals Corporation 0078-0603_11fa07d0-de9c-4b02-b27c-ed3ee432c34c 0078-0603 HUMAN PRESCRIPTION DRUG Tekamlo Aliskiren Hemifumarate and Amlodipine Besylate TABLET, FILM COATED ORAL 20100101 NDA NDA022545 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE 150; 5 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0078-0604_11fa07d0-de9c-4b02-b27c-ed3ee432c34c 0078-0604 HUMAN PRESCRIPTION DRUG Tekamlo Aliskiren Hemifumarate and Amlodipine Besylate TABLET, FILM COATED ORAL 20100101 NDA NDA022545 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE 150; 10 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0078-0605_11fa07d0-de9c-4b02-b27c-ed3ee432c34c 0078-0605 HUMAN PRESCRIPTION DRUG Tekamlo Aliskiren Hemifumarate and Amlodipine Besylate TABLET, FILM COATED ORAL 20100101 NDA NDA022545 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE 300; 5 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0078-0606_11fa07d0-de9c-4b02-b27c-ed3ee432c34c 0078-0606 HUMAN PRESCRIPTION DRUG Tekamlo Aliskiren Hemifumarate and Amlodipine Besylate TABLET, FILM COATED ORAL 20100101 NDA NDA022545 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE 300; 10 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0078-0607_aadcde42-f818-4207-9071-7ab01b8408ea 0078-0607 HUMAN PRESCRIPTION DRUG Gilenya Fingolimod hcl CAPSULE ORAL 20100921 NDA NDA022527 Novartis Pharmaceuticals Corporation FINGOLIMOD HYDROCHLORIDE .5 mg/1 Sphingosine 1-Phosphate Receptor Modulators [MoA],Sphingosine 1-phosphate Receptor Modulator [EPC] 0078-0608_bb7f8a24-7c97-4537-9901-3c6ea16b4893 0078-0608 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 25 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0609_bb7f8a24-7c97-4537-9901-3c6ea16b4893 0078-0609 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 35 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0078-0610_5514e3b0-22f5-4174-afe0-14718cbb95c7 0078-0610 HUMAN PRESCRIPTION DRUG Amturnide Aliskiren Hemifumarate and Amlodipine Besylate and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101221 NDA NDA200045 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 150; 5; 12.5 mg/1; mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0611_5514e3b0-22f5-4174-afe0-14718cbb95c7 0078-0611 HUMAN PRESCRIPTION DRUG Amturnide Aliskiren Hemifumarate and Amlodipine Besylate and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101221 NDA NDA200045 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 300; 5; 12.5 mg/1; mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0612_5514e3b0-22f5-4174-afe0-14718cbb95c7 0078-0612 HUMAN PRESCRIPTION DRUG Amturnide Aliskiren Hemifumarate and Amlodipine Besylate and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101221 NDA NDA200045 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 300; 5; 25 mg/1; mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0613_5514e3b0-22f5-4174-afe0-14718cbb95c7 0078-0613 HUMAN PRESCRIPTION DRUG Amturnide Aliskiren Hemifumarate and Amlodipine Besylate and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101221 NDA NDA200045 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 300; 10; 12.5 mg/1; mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0078-0614_5514e3b0-22f5-4174-afe0-14718cbb95c7 0078-0614 HUMAN PRESCRIPTION DRUG Amturnide Aliskiren Hemifumarate and Amlodipine Besylate and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101221 NDA NDA200045 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 300; 10; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Renin Inhibitor [EPC],Renin Inhibitors [MoA] 0078-0616_99b9a738-b0f7-4213-b15f-a9d3f7e82570 0078-0616 HUMAN PRESCRIPTION DRUG Hecoria Tacrolimus CAPSULE ORAL 20111220 ANDA ANDA065461 Novartis Pharmaceuticals Corporation TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0078-0617_99b9a738-b0f7-4213-b15f-a9d3f7e82570 0078-0617 HUMAN PRESCRIPTION DRUG Hecoria Tacrolimus CAPSULE ORAL 20111220 ANDA ANDA065461 Novartis Pharmaceuticals Corporation TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0078-0618_99b9a738-b0f7-4213-b15f-a9d3f7e82570 0078-0618 HUMAN PRESCRIPTION DRUG Hecoria Tacrolimus CAPSULE ORAL 20111220 ANDA ANDA065461 Novartis Pharmaceuticals Corporation TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0078-0619_667e2dcc-3942-4c17-91d2-4f1936a02633 0078-0619 HUMAN PRESCRIPTION DRUG Arcapta Neohaler Indacaterol maleate CAPSULE ORAL; RESPIRATORY (INHALATION) 20110701 NDA NDA022383 Novartis Pharmaceuticals Corporation INDACATEROL MALEATE 75 ug/1 0078-0620_ee8b355a-e598-4c57-a1d0-ba96ce5f0155 0078-0620 HUMAN PRESCRIPTION DRUG Afinitor everolimus TABLET ORAL 20110729 NDA NDA022334 Novartis Pharmaceuticals Corporation EVEROLIMUS 7.5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0078-0626_ee8b355a-e598-4c57-a1d0-ba96ce5f0155 0078-0626 HUMAN PRESCRIPTION DRUG Afinitor Disperz everolimus TABLET, FOR SUSPENSION ORAL 20120829 NDA NDA203985 Novartis Pharmaceuticals Corporation EVEROLIMUS 2 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0078-0627_ee8b355a-e598-4c57-a1d0-ba96ce5f0155 0078-0627 HUMAN PRESCRIPTION DRUG Afinitor Disperz everolimus TABLET, FOR SUSPENSION ORAL 20120829 NDA NDA203985 Novartis Pharmaceuticals Corporation EVEROLIMUS 3 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0078-0628_ee8b355a-e598-4c57-a1d0-ba96ce5f0155 0078-0628 HUMAN PRESCRIPTION DRUG Afinitor Disperz everolimus TABLET, FOR SUSPENSION ORAL 20120829 NDA NDA203985 Novartis Pharmaceuticals Corporation EVEROLIMUS 5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0078-0630_6659a17c-d1a1-43c6-8dba-a94de47e7c19 0078-0630 HUMAN PRESCRIPTION DRUG TOBI Podhaler Tobramycin CAPSULE ORAL; RESPIRATORY (INHALATION) 20130322 NDA NDA201688 Novartis Pharmaceuticals Corporation TOBRAMYCIN 28 mg/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0078-0633_88ecfc4f-cb6f-4306-9f74-d63f7097d3cb 0078-0633 HUMAN PRESCRIPTION DRUG Signifor pasireotide INJECTION SUBCUTANEOUS 20121214 NDA NDA200677 Novartis Pharmaceuticals Corporation PASIREOTIDE .3 mg/mL 0078-0634_88ecfc4f-cb6f-4306-9f74-d63f7097d3cb 0078-0634 HUMAN PRESCRIPTION DRUG Signifor pasireotide INJECTION SUBCUTANEOUS 20121214 NDA NDA200677 Novartis Pharmaceuticals Corporation PASIREOTIDE .6 mg/mL 0078-0635_88ecfc4f-cb6f-4306-9f74-d63f7097d3cb 0078-0635 HUMAN PRESCRIPTION DRUG Signifor pasireotide INJECTION SUBCUTANEOUS 20121214 NDA NDA200677 Novartis Pharmaceuticals Corporation PASIREOTIDE .9 mg/mL 0078-0640_11777191-b199-4081-9aa6-2f935beb3a17 0078-0640 HUMAN PRESCRIPTION DRUG ZYKADIA ceritinib CAPSULE ORAL 20140429 NDA NDA205755 Novartis Pharmaceuticals Corporation CERITINIB 150 mg/1 Kinase Inhibitor [EPC],Receptor Tyrosine Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0078-0641_5504116c-d531-4d47-b160-41c6671d52aa 0078-0641 HUMAN PRESCRIPTION DRUG Signifor LAR pasireotide KIT 20141215 NDA NDA203255 Novartis Pharmaceuticals Corporation 0078-0642_5504116c-d531-4d47-b160-41c6671d52aa 0078-0642 HUMAN PRESCRIPTION DRUG Signifor LAR pasireotide KIT 20141215 NDA NDA203255 Novartis Pharmaceuticals Corporation 0078-0643_5504116c-d531-4d47-b160-41c6671d52aa 0078-0643 HUMAN PRESCRIPTION DRUG Signifor LAR pasireotide KIT 20141215 NDA NDA203255 Novartis Pharmaceuticals Corporation 0078-0649_cccd8152-9ff2-4e91-a8eb-91c0fe48c3e4 0078-0649 HUMAN PRESCRIPTION DRUG Gleevec imatinib mesylate TABLET ORAL 20141223 NDA NDA021588 Novartis Pharmaceuticals Corporation IMATINIB MESYLATE 400 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0078-9342_aab8ec14-84ee-4fd0-8be3-925bf1724ce3 0078-9342 HUMAN PRESCRIPTION DRUG Sandostatin LAR Depot Demonstration Kit octreotide acetate KIT 19881101 NDA NDA021008 Novartis Pharmaceuticals Corporation 0085-0091_726124e3-de9d-4e5e-9fdd-ad162c461685 0085-0091 HUMAN PRESCRIPTION DRUG IMDUR isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20060105 ANDA ANDA075155 Schering Corporation ISOSORBIDE MONONITRATE 120 mg/1 0085-0314_dfab77e8-337d-404e-9719-162aae7e2351 0085-0314 HUMAN PRESCRIPTION DRUG VICTRELIS BOCEPREVIR CAPSULE ORAL 20110513 NDA NDA202258 Merck Sharp & Dohme Corp. BOCEPREVIR 200 mg/1 HCV NS3/4A Protease Inhibitors [MoA],Hepatitis C Virus NS3/4A Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA] 0085-0370_3bc023ff-9289-4c7a-8f4c-f81cc7ea6df1 0085-0370 HUMAN PRESCRIPTION DRUG ELOCON mometasone furoate OINTMENT TOPICAL 19870430 NDA NDA019543 Merck Sharp & Dohme Corp. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0085-0492_3795461a-d394-4446-ac0a-5129cb976cd8 0085-0492 HUMAN PRESCRIPTION DRUG Guanidine hydrochloride Guanidine hydrochloride TABLET ORAL 19391002 NDA NDA001546 Merck Sharp & Dohme Corp. GUANIDINE HYDROCHLORIDE 125 mg/1 Acetylcholine Releasing Agent [EPC],Increased Acetylcholine Activity [PE] 0085-0517_fd55d570-7ce6-4448-8edc-0b677c96e8f7 0085-0517 HUMAN PRESCRIPTION DRUG DIPROLENE AF betamethasone dipropionate CREAM TOPICAL 19870427 NDA NDA019555 Merck Sharp & Dohme Corp. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0085-0539_f6b948ee-12b2-4443-b54f-a10141965e79 0085-0539 HUMAN PRESCRIPTION DRUG INTRON A Interferon alfa-2b KIT 19860604 BLA BLA103132 Merck Sharp & Dohme Corp. 0085-0566_85c0a29a-ec24-44e6-b300-58fe58d5809e 0085-0566 HUMAN PRESCRIPTION DRUG CELESTONE SOLUSPAN Betamethasone Acetate and Betamethasone Sodium Phosphate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 19650315 NDA NDA014602 Merck Sharp & Dohme Corp. BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE 3; 3 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0085-0567_62605cd0-212e-401b-bbe9-18de6886d486 0085-0567 HUMAN PRESCRIPTION DRUG ELOCON Mometasone Furoate CREAM TOPICAL 19870506 NDA NDA019625 Merck Sharp & Dohme Corp. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0085-0571_f6b948ee-12b2-4443-b54f-a10141965e79 0085-0571 HUMAN PRESCRIPTION DRUG INTRON A Interferon alfa-2b KIT 19860604 BLA BLA103132 Merck Sharp & Dohme Corp. 0085-0575_e79e84ec-fb29-4186-aab1-b0c6e96547e8 0085-0575 HUMAN PRESCRIPTION DRUG DIPROLENE betamethasone dipropionate OINTMENT TOPICAL 19830727 NDA NDA018741 Merck Sharp & Dohme Corp. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0085-0819_a3925ec2-2c8e-4c48-b4dd-d7655f823173 0085-0819 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 19950404 NDA NDA020145 Merck Sharp & Dohme Corp. NITROGLYCERIN 160 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0085-0854_44d631b1-6e50-4dcc-9028-18761ef21d1b 0085-0854 HUMAN PRESCRIPTION DRUG ELOCON Mometasone Furoate LOTION TOPICAL 19890330 NDA NDA019796 Merck Sharp & Dohme Corp. MOMETASONE FUROATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0085-0924_8cd5ab45-f658-416b-9f58-58b465ebbee9 0085-0924 HUMAN PRESCRIPTION DRUG Lotrisone Clotrimazole and Betamethasone dipropionate CREAM TOPICAL 19840710 NDA NDA018827 Merck Sharp & Dohme Corp. BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE .5; 10 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0085-0962_d0a02f18-cf77-4ffd-8e66-176199ca58af 0085-0962 HUMAN PRESCRIPTION DRUG DIPROLENE betamethasone dipropionate LOTION TOPICAL 19880801 NDA NDA019716 Merck Sharp & Dohme Corp. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0085-1110_f6b948ee-12b2-4443-b54f-a10141965e79 0085-1110 HUMAN PRESCRIPTION DRUG INTRON A Interferon alfa-2b KIT 19860604 BLA BLA103132 Merck Sharp & Dohme Corp. 0085-1132_e5ae5d23-a2bf-411b-87c6-810a712e4f7c 0085-1132 HUMAN PRESCRIPTION DRUG Proventil HFA Albuterol Sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20011001 NDA NDA020503 Merck Sharp & Dohme Corp. ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0085-1133_e5baa082-f5cd-4f70-b2eb-39a890543a12 0085-1133 HUMAN PRESCRIPTION DRUG INTRON A Interferon alfa-2b INJECTION, SOLUTION INTRALESIONAL; INTRAMUSCULAR; SUBCUTANEOUS 19860604 BLA BLA103132 Merck Sharp & Dohme Corp. INTERFERON ALFA-2B 19.2 ug/.5mL Interferon Alfa-2b [Chemical/Ingredient],Interferon alpha [EPC],Interferon-alpha [Chemical/Ingredient] 0085-1136_0d4f321d-46bb-4789-a1a3-a6fbc08c61fa 0085-1136 HUMAN PRESCRIPTION DRUG Integrilin Eptifibatide INJECTION, SOLUTION INTRAVENOUS 19980518 NDA NDA020718 Merck Sharp & Dohme Corp. EPTIFIBATIDE .75 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0085-1136_27acb463-64cf-4e25-a294-2b9022848225 0085-1136 HUMAN PRESCRIPTION DRUG Integrilin Eptifibatide INJECTION, SOLUTION INTRAVENOUS 20140818 NDA NDA020718 Merck Sharp & Dohme Corp. EPTIFIBATIDE .75 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0085-1168_e5baa082-f5cd-4f70-b2eb-39a890543a12 0085-1168 HUMAN PRESCRIPTION DRUG INTRON A Interferon alfa-2b INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 19860604 BLA BLA103132 Merck Sharp & Dohme Corp. INTERFERON ALFA-2B 11.6 ug/.5mL Interferon Alfa-2b [Chemical/Ingredient],Interferon alpha [EPC],Interferon-alpha [Chemical/Ingredient] 0085-1177_0d4f321d-46bb-4789-a1a3-a6fbc08c61fa 0085-1177 HUMAN PRESCRIPTION DRUG Integrilin Eptifibatide INJECTION, SOLUTION INTRAVENOUS 19980518 NDA NDA020718 Merck Sharp & Dohme Corp. EPTIFIBATIDE 2 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0085-1194_24bc568f-32a4-4ba7-8157-bbbd1e3e21e9 0085-1194 HUMAN PRESCRIPTION DRUG REBETOL ribavirin CAPSULE ORAL 19980603 NDA NDA020903 Merck Sharp & Dohme Corp. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 0085-1264_14ad0485-2a57-43c6-bdf4-561c7fe9a755 0085-1264 HUMAN PRESCRIPTION DRUG Clarinex Desloratadine TABLET, FILM COATED ORAL 20011221 NDA NDA021165 Merck Sharp & Dohme Corp. DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0085-1279_9e71ada1-27a1-4b6a-b403-cf122df087ac 0085-1279 HUMAN PRESCRIPTION DRUG PEGINTRON peginterferon alfa-2b KIT 20010119 BLA BLA103949 Merck Sharp & Dohme Corp. 0085-1287_34decc89-74d4-40b0-82ee-e816864517d9 0085-1287 HUMAN PRESCRIPTION DRUG SYLATRON peginterferon alfa-2b KIT 20110329 BLA BLA103949 Merck Sharp & Dohme Corp. 0085-1288_64c52e50-dc68-43cd-b73d-bb6542997f2a 0085-1288 HUMAN PRESCRIPTION DRUG NASONEX Mometasone furoate monohydrate SPRAY, METERED NASAL 19971001 NDA NDA020762 Merck Sharp & Dohme Corp. MOMETASONE FUROATE MONOHYDRATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0085-1291_9e71ada1-27a1-4b6a-b403-cf122df087ac 0085-1291 HUMAN PRESCRIPTION DRUG PEGINTRON peginterferon alfa-2b KIT 20010119 BLA BLA103949 Merck Sharp & Dohme Corp. 0085-1297_245feb39-3777-4b7a-8879-eabcf92d49ac 0085-1297 HUMAN PRESCRIPTION DRUG PEGINTRON Peginterferon alfa-2b INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20010119 BLA BLA103949 Merck Sharp & Dohme Corp. PEGINTERFERON ALFA-2B 120 ug/.5mL Interferon Alfa-2b [Chemical/Ingredient],Interferon alpha [EPC],Interferon-alpha [Chemical/Ingredient] 0085-1304_9e71ada1-27a1-4b6a-b403-cf122df087ac 0085-1304 HUMAN PRESCRIPTION DRUG PEGINTRON peginterferon alfa-2b KIT 20010119 BLA BLA103949 Merck Sharp & Dohme Corp. 0085-1312_34decc89-74d4-40b0-82ee-e816864517d9 0085-1312 HUMAN PRESCRIPTION DRUG SYLATRON peginterferon alfa-2b KIT 20110329 BLA BLA103949 Merck Sharp & Dohme Corp. 0085-1316_245feb39-3777-4b7a-8879-eabcf92d49ac 0085-1316 HUMAN PRESCRIPTION DRUG PEGINTRON Peginterferon alfa-2b INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20010119 BLA BLA103949 Merck Sharp & Dohme Corp. PEGINTERFERON ALFA-2B 80 ug/.5mL Interferon Alfa-2b [Chemical/Ingredient],Interferon alpha [EPC],Interferon-alpha [Chemical/Ingredient] 0085-1318_24bc568f-32a4-4ba7-8157-bbbd1e3e21e9 0085-1318 HUMAN PRESCRIPTION DRUG REBETOL ribavirin LIQUID ORAL 20030729 NDA NDA021546 Merck Sharp & Dohme Corp. RIBAVIRIN 40 mg/mL Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 0085-1322_1d0efe62-6e65-4b2b-83a0-d76c5ed62c4e 0085-1322 HUMAN PRESCRIPTION DRUG CLARINEX-D 12 HOUR desloratadine and pseudoephedrine sulfate TABLET, EXTENDED RELEASE ORAL 20060201 NDA NDA021313 Merck Sharp & Dohme Corp. DESLORATADINE; PSEUDOEPHEDRINE SULFATE 2.5; 120 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0085-1323_245feb39-3777-4b7a-8879-eabcf92d49ac 0085-1323 HUMAN PRESCRIPTION DRUG PEGINTRON Peginterferon alfa-2b INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20010119 BLA BLA103949 Merck Sharp & Dohme Corp. PEGINTERFERON ALFA-2B 50 ug/.5mL Interferon Alfa-2b [Chemical/Ingredient],Interferon alpha [EPC],Interferon-alpha [Chemical/Ingredient] 0085-1328_d4239e7b-7049-4989-b92d-6281636d5df5 0085-1328 HUMAN PRESCRIPTION DRUG NOXAFIL posaconazole SUSPENSION ORAL 20060915 NDA NDA022003 Merck Sharp & Dohme Corp. POSACONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0085-1334_14ad0485-2a57-43c6-bdf4-561c7fe9a755 0085-1334 HUMAN PRESCRIPTION DRUG Clarinex Desloratadine SOLUTION ORAL 20040901 NDA NDA021300 Merck Sharp & Dohme Corp. DESLORATADINE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0085-1341_5ff4ad68-7890-49f2-837b-ac9a2d76ce4d 0085-1341 HUMAN PRESCRIPTION DRUG ASMANEX Mometasone Furoate INHALANT RESPIRATORY (INHALATION) 20050330 NDA NDA021067 Merck Sharp & Dohme Corp. MOMETASONE FUROATE 220 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0085-1351_24bc568f-32a4-4ba7-8157-bbbd1e3e21e9 0085-1351 HUMAN PRESCRIPTION DRUG REBETOL ribavirin CAPSULE ORAL 19980603 NDA NDA020903 Merck Sharp & Dohme Corp. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 0085-1366_2bbdd58b-a2ea-49bc-a523-61e1311fba47 0085-1366 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 19990811 NDA NDA021029 Merck Sharp & Dohme Corp. TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0085-1368_9e71ada1-27a1-4b6a-b403-cf122df087ac 0085-1368 HUMAN PRESCRIPTION DRUG PEGINTRON peginterferon alfa-2b KIT 20010119 BLA BLA103949 Merck Sharp & Dohme Corp. 0085-1370_245feb39-3777-4b7a-8879-eabcf92d49ac 0085-1370 HUMAN PRESCRIPTION DRUG PEGINTRON Peginterferon alfa-2b INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20010119 BLA BLA103949 Merck Sharp & Dohme Corp. PEGINTERFERON ALFA-2B 150 ug/.5mL Interferon Alfa-2b [Chemical/Ingredient],Interferon alpha [EPC],Interferon-alpha [Chemical/Ingredient] 0085-1374_726124e3-de9d-4e5e-9fdd-ad162c461685 0085-1374 HUMAN PRESCRIPTION DRUG IMDUR isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20060105 ANDA ANDA075155 Schering Corporation ISOSORBIDE MONONITRATE 30 mg/1 0085-1381_2bbdd58b-a2ea-49bc-a523-61e1311fba47 0085-1381 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090227 NDA NDA022277 Merck Sharp & Dohme Corp. TEMOZOLOMIDE 2.5 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] 0085-1385_24bc568f-32a4-4ba7-8157-bbbd1e3e21e9 0085-1385 HUMAN PRESCRIPTION DRUG REBETOL ribavirin CAPSULE ORAL 19980603 NDA NDA020903 Merck Sharp & Dohme Corp. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 0085-1388_34decc89-74d4-40b0-82ee-e816864517d9 0085-1388 HUMAN PRESCRIPTION DRUG SYLATRON peginterferon alfa-2b KIT 20110329 BLA BLA103949 Merck Sharp & Dohme Corp. 0085-1401_00bebd7a-774a-41d5-9f65-aa625531f6f7 0085-1401 HUMAN PRESCRIPTION DRUG Foradil formoterol fumarate CAPSULE RESPIRATORY (INHALATION) 20010216 NDA NDA020831 Merck Sharp & Dohme Corp. FORMOTEROL FUMARATE 12 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0085-1402_00bebd7a-774a-41d5-9f65-aa625531f6f7 0085-1402 HUMAN PRESCRIPTION DRUG Foradil formoterol fumarate CAPSULE RESPIRATORY (INHALATION) 20010216 NDA NDA020831 Merck Sharp & Dohme Corp. FORMOTEROL FUMARATE 12 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0085-1417_2bbdd58b-a2ea-49bc-a523-61e1311fba47 0085-1417 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 19990811 NDA NDA021029 Merck Sharp & Dohme Corp. TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0085-1425_2bbdd58b-a2ea-49bc-a523-61e1311fba47 0085-1425 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 19990811 NDA NDA021029 Merck Sharp & Dohme Corp. TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0085-1430_2bbdd58b-a2ea-49bc-a523-61e1311fba47 0085-1430 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 19990811 NDA NDA021029 Merck Sharp & Dohme Corp. TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0085-1461_5ff4ad68-7890-49f2-837b-ac9a2d76ce4d 0085-1461 HUMAN PRESCRIPTION DRUG ASMANEX Mometasone Furoate INHALANT RESPIRATORY (INHALATION) 20050330 NDA NDA021067 Merck Sharp & Dohme Corp. MOMETASONE FUROATE 110 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0085-1519_2bbdd58b-a2ea-49bc-a523-61e1311fba47 0085-1519 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 19990811 NDA NDA021029 Merck Sharp & Dohme Corp. TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0085-1733_9fade4a0-6217-46f6-802b-5087680e7a56 0085-1733 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride TABLET, FILM COATED ORAL 19991210 NDA NDA021085 Schering Plough Corporation MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0085-1737_9fade4a0-6217-46f6-802b-5087680e7a56 0085-1737 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride INJECTION, SOLUTION INTRAVENOUS 20011130 NDA NDA021277 Schering Plough Corporation MOXIFLOXACIN HYDROCHLORIDE 400 mg/250mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0085-2028_726124e3-de9d-4e5e-9fdd-ad162c461685 0085-2028 HUMAN PRESCRIPTION DRUG IMDUR isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20060105 ANDA ANDA075155 Schering Corporation ISOSORBIDE MONONITRATE 60 mg/1 0085-3004_2bbdd58b-a2ea-49bc-a523-61e1311fba47 0085-3004 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 19990811 NDA NDA021029 Merck Sharp & Dohme Corp. TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0085-3149_62605cd0-212e-401b-bbe9-18de6886d486 0085-3149 HUMAN PRESCRIPTION DRUG ELOCON Mometasone Furoate CREAM TOPICAL 19870506 NDA NDA019625 Merck Sharp & Dohme Corp. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0085-3305_a3925ec2-2c8e-4c48-b4dd-d7655f823173 0085-3305 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 19950404 NDA NDA020145 Merck Sharp & Dohme Corp. NITROGLYCERIN 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0085-3310_a3925ec2-2c8e-4c48-b4dd-d7655f823173 0085-3310 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 19950404 NDA NDA020145 Merck Sharp & Dohme Corp. NITROGLYCERIN 40 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0085-3315_a3925ec2-2c8e-4c48-b4dd-d7655f823173 0085-3315 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 19950404 NDA NDA020145 Merck Sharp & Dohme Corp. NITROGLYCERIN 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0085-3320_a3925ec2-2c8e-4c48-b4dd-d7655f823173 0085-3320 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 19950404 NDA NDA020145 Merck Sharp & Dohme Corp. NITROGLYCERIN 80 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0085-3330_a3925ec2-2c8e-4c48-b4dd-d7655f823173 0085-3330 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 19950404 NDA NDA020145 Merck Sharp & Dohme Corp. NITROGLYCERIN 120 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0085-4324_d4239e7b-7049-4989-b92d-6281636d5df5 0085-4324 HUMAN PRESCRIPTION DRUG NOXAFIL posaconazole TABLET, COATED ORAL 20131125 NDA NDA205053 Merck Sharp & Dohme Corp. POSACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0085-4331_d4239e7b-7049-4989-b92d-6281636d5df5 0085-4331 HUMAN PRESCRIPTION DRUG NOXAFIL posaconazole SOLUTION INTRAVENOUS 20140313 NDA NDA205596 Merck Sharp & Dohme Corp. POSACONAZOLE 18 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0085-4333_5eb17433-96c5-416d-9585-9fc1d2bebde1 0085-4333 HUMAN PRESCRIPTION DRUG ASMANEX HFA MOMETASONE FUROATE AEROSOL RESPIRATORY (INHALATION) 20140425 NDA NDA205641 Merck Sharp & Dohme Corp. MOMETASONE FUROATE 100 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0085-4334_5eb17433-96c5-416d-9585-9fc1d2bebde1 0085-4334 HUMAN PRESCRIPTION DRUG ASMANEX HFA MOMETASONE FUROATE AEROSOL RESPIRATORY (INHALATION) 20140425 NDA NDA205641 Merck Sharp & Dohme Corp. MOMETASONE FUROATE 200 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0085-4347_019cbd92-7f2c-4026-981c-31ffa03871cd 0085-4347 HUMAN PRESCRIPTION DRUG SYLATRON peginterferon alfa-2b KIT 20140830 BLA BLA103949 Merck Sharp & Dohme Corp. 0085-4348_019cbd92-7f2c-4026-981c-31ffa03871cd 0085-4348 HUMAN PRESCRIPTION DRUG SYLATRON peginterferon alfa-2b KIT 20110329 BLA BLA103949 Merck Sharp & Dohme Corp. 0085-4349_019cbd92-7f2c-4026-981c-31ffa03871cd 0085-4349 HUMAN PRESCRIPTION DRUG SYLATRON peginterferon alfa-2b KIT 20110329 BLA BLA103949 Merck Sharp & Dohme Corp. 0085-4350_e5baa082-f5cd-4f70-b2eb-39a890543a12 0085-4350 HUMAN PRESCRIPTION DRUG INTRON A interferon alfa-2b KIT 20140811 BLA BLA103132 Merck Sharp & Dohme Corp. 0085-4351_e5baa082-f5cd-4f70-b2eb-39a890543a12 0085-4351 HUMAN PRESCRIPTION DRUG INTRON A interferon alfa-2b KIT 20140811 BLA BLA103132 Merck Sharp & Dohme Corp. 0085-4352_e5baa082-f5cd-4f70-b2eb-39a890543a12 0085-4352 HUMAN PRESCRIPTION DRUG INTRON A interferon alfa-2b KIT 20140811 BLA BLA103132 Merck Sharp & Dohme Corp. 0085-4353_245feb39-3777-4b7a-8879-eabcf92d49ac 0085-4353 HUMAN PRESCRIPTION DRUG PEGINTRON peginterferon alfa-2b KIT 20140811 BLA BLA103949 Merck Sharp & Dohme Corp. 0085-4354_245feb39-3777-4b7a-8879-eabcf92d49ac 0085-4354 HUMAN PRESCRIPTION DRUG PEGINTRON peginterferon alfa-2b KIT 20140811 BLA BLA103949 Merck Sharp & Dohme Corp. 0085-4355_245feb39-3777-4b7a-8879-eabcf92d49ac 0085-4355 HUMAN PRESCRIPTION DRUG PEGINTRON peginterferon alfa-2b KIT 20140811 BLA BLA103949 Merck Sharp & Dohme Corp. 0085-4356_245feb39-3777-4b7a-8879-eabcf92d49ac 0085-4356 HUMAN PRESCRIPTION DRUG PEGINTRON peginterferon alfa-2b KIT 20140811 BLA BLA103949 Merck Sharp & Dohme Corp. 0085-4610_21af5460-0aac-4b4d-8d1f-0ebca8e101c9 0085-4610 HUMAN PRESCRIPTION DRUG Dulera mometasone furoate and formoterol fumarate dihydrate AEROSOL RESPIRATORY (INHALATION) 20100622 NDA NDA022518 Merck Sharp & Dohme Corp. FORMOTEROL FUMARATE; MOMETASONE FUROATE 5; 200 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0085-7206_21af5460-0aac-4b4d-8d1f-0ebca8e101c9 0085-7206 HUMAN PRESCRIPTION DRUG Dulera mometasone furoate and formoterol fumarate dihydrate AEROSOL RESPIRATORY (INHALATION) 20100622 NDA NDA022518 Merck Sharp & Dohme Corp. FORMOTEROL FUMARATE; MOMETASONE FUROATE 5; 100 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0087-2771_928a14af-4865-47e7-8803-57678039d656 0087-2771 HUMAN PRESCRIPTION DRUG AVAPRO IRBESARTAN TABLET ORAL 19970930 20150831 NDA NDA020757 Bristol-Myers Squibb Company IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0087-2772_928a14af-4865-47e7-8803-57678039d656 0087-2772 HUMAN PRESCRIPTION DRUG AVAPRO IRBESARTAN TABLET ORAL 19970930 20160331 NDA NDA020757 Bristol-Myers Squibb Company IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0087-2773_928a14af-4865-47e7-8803-57678039d656 0087-2773 HUMAN PRESCRIPTION DRUG AVAPRO IRBESARTAN TABLET ORAL 19970930 20160331 NDA NDA020757 Bristol-Myers Squibb Company IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0087-2875_85ab1689-68f7-4e98-a3a5-ed35386292de 0087-2875 HUMAN PRESCRIPTION DRUG AVALIDE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20110225 20150831 NDA NDA020758 Bristol-Myers Squibb Company HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0087-2876_85ab1689-68f7-4e98-a3a5-ed35386292de 0087-2876 HUMAN PRESCRIPTION DRUG AVALIDE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20110224 20151130 NDA NDA020758 Bristol-Myers Squibb Company HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0087-6060_b70560f3-91dc-47f5-8b97-957b0ecc3ccf 0087-6060 HUMAN PRESCRIPTION DRUG GLUCOPHAGE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20090601 NDA NDA020357 Bristol-Myers Squibb Company METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0087-6063_b70560f3-91dc-47f5-8b97-957b0ecc3ccf 0087-6063 HUMAN PRESCRIPTION DRUG GLUCOPHAGE XR METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20090601 NDA NDA021202 Bristol-Myers Squibb Company METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0087-6064_b70560f3-91dc-47f5-8b97-957b0ecc3ccf 0087-6064 HUMAN PRESCRIPTION DRUG GLUCOPHAGE XR METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20090601 NDA NDA021202 Bristol-Myers Squibb Company METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0087-6070_b70560f3-91dc-47f5-8b97-957b0ecc3ccf 0087-6070 HUMAN PRESCRIPTION DRUG GLUCOPHAGE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20090601 NDA NDA020357 Bristol-Myers Squibb Company METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0087-6071_b70560f3-91dc-47f5-8b97-957b0ecc3ccf 0087-6071 HUMAN PRESCRIPTION DRUG GLUCOPHAGE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20090601 NDA NDA020357 Bristol-Myers Squibb Company METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0087-6073_d5ebab4c-b944-446d-a388-f144abd47fb4 0087-6073 HUMAN PRESCRIPTION DRUG GLUCOVANCE GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20081215 NDA NDA021178 Bristol-Myers Squibb Company GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0087-6074_d5ebab4c-b944-446d-a388-f144abd47fb4 0087-6074 HUMAN PRESCRIPTION DRUG GLUCOVANCE GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20081215 NDA NDA021178 Bristol-Myers Squibb Company GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0087-6632_3fa5142e-1bd4-4487-91a1-76eaef65ebf2 0087-6632 HUMAN PRESCRIPTION DRUG VIDEX didanosine POWDER, FOR SOLUTION ORAL 19911009 NDA NDA020156 Bristol-Myers Squibb Company DIDANOSINE 10 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0087-6633_3fa5142e-1bd4-4487-91a1-76eaef65ebf2 0087-6633 HUMAN PRESCRIPTION DRUG VIDEX didanosine POWDER, FOR SOLUTION ORAL 19911009 NDA NDA020156 Bristol-Myers Squibb Company DIDANOSINE 10 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0087-6671_83f4464b-9548-459c-9e47-1ef47b73c35c 0087-6671 HUMAN PRESCRIPTION DRUG VIDEX EC didanosine CAPSULE, DELAYED RELEASE ORAL 20001031 NDA NDA021183 Bristol-Myers Squibb Company DIDANOSINE 125 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0087-6672_83f4464b-9548-459c-9e47-1ef47b73c35c 0087-6672 HUMAN PRESCRIPTION DRUG VIDEX EC didanosine CAPSULE, DELAYED RELEASE ORAL 20001031 NDA NDA021183 Bristol-Myers Squibb Company DIDANOSINE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0087-6673_83f4464b-9548-459c-9e47-1ef47b73c35c 0087-6673 HUMAN PRESCRIPTION DRUG VIDEX EC didanosine CAPSULE, DELAYED RELEASE ORAL 20001031 NDA NDA021183 Bristol-Myers Squibb Company DIDANOSINE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0087-6674_83f4464b-9548-459c-9e47-1ef47b73c35c 0087-6674 HUMAN PRESCRIPTION DRUG VIDEX EC didanosine CAPSULE, DELAYED RELEASE ORAL 20001031 NDA NDA021183 Bristol-Myers Squibb Company DIDANOSINE 400 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0088-0576_99e5e964-c6d0-422d-8555-a67d80d15453 0088-0576 HUMAN PRESCRIPTION DRUG Rifater rifampin, isoniazid and pyrazinamide TABLET, SUGAR COATED ORAL 19940531 NDA NDA050705 sanofi-aventis U.S. LLC ISONIAZID; PYRAZINAMIDE; RIFAMPIN 50; 300; 120 mg/1; mg/1; mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient],Antimycobacterial [EPC],Antimycobacterial [EPC] 0088-1090_0af9d08a-03a2-4626-8049-6822d108c4c0 0088-1090 HUMAN PRESCRIPTION DRUG Allegra D-12 Hour fexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 19971224 NDA NDA020786 sanofi-aventis U.S. LLC FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0088-1095_ddeb18f2-822a-45ce-b8da-5e93f185ff2b 0088-1095 HUMAN PRESCRIPTION DRUG Allegra--D 24 Hour fexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, FILM COATED ORAL 20041019 NDA NDA021704 sanofi-aventis U.S. LLC FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180; 240 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0088-1097_2892ecac-9078-460d-a940-2be297b6da59 0088-1097 HUMAN PRESCRIPTION DRUG ALLEGRA fexofenadine hydrochloride SUSPENSION ORAL 20061016 NDA NDA021963 sanofi-aventis U.S. LLC FEXOFENADINE HYDROCHLORIDE 6 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0088-1111_7fc5e6f1-25b1-45b6-9655-35d094c9cc89 0088-1111 HUMAN PRESCRIPTION DRUG Nilandron Nilutamide TABLET ORAL 19960919 NDA NDA020169 sanofi-aventis U.S. LLC NILUTAMIDE 150 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 0088-1202_2af2ca54-c0d7-4b54-91e4-acf6f92e5544 0088-1202 HUMAN PRESCRIPTION DRUG Anzemet dolasetron mesylate TABLET, FILM COATED ORAL 19970911 NDA NDA020623 sanofi-aventis U.S. LLC DOLASETRON MESYLATE 50 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0088-1203_2af2ca54-c0d7-4b54-91e4-acf6f92e5544 0088-1203 HUMAN PRESCRIPTION DRUG Anzemet dolasetron mesylate TABLET, FILM COATED ORAL 19970911 NDA NDA020623 sanofi-aventis U.S. LLC DOLASETRON MESYLATE 100 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0088-1206_9a32e15f-3a74-4fd6-934f-58f94836be80 0088-1206 HUMAN PRESCRIPTION DRUG Anzemet dolasetron mesylate INJECTION INTRAVENOUS 19970911 NDA NDA020624 sanofi-aventis U.S. LLC DOLASETRON MESYLATE 100 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0088-1208_9a32e15f-3a74-4fd6-934f-58f94836be80 0088-1208 HUMAN PRESCRIPTION DRUG Anzemet dolasetron mesylate INJECTION INTRAVENOUS 19970911 NDA NDA020624 sanofi-aventis U.S. LLC DOLASETRON MESYLATE 12.5 mg/.625mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0088-1209_9a32e15f-3a74-4fd6-934f-58f94836be80 0088-1209 HUMAN PRESCRIPTION DRUG Anzemet dolasetron mesylate INJECTION INTRAVENOUS 19970911 NDA NDA020624 sanofi-aventis U.S. LLC DOLASETRON MESYLATE 500 mg/25mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0088-2100_355c83f1-a99f-4aee-b5a6-0377291ad1e6 0088-2100 HUMAN PRESCRIPTION DRUG Priftin rifapentine TABLET, FILM COATED ORAL 20090330 NDA NDA021024 sanofi-aventis U.S. LLC RIFAPENTINE 150 mg/1 Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient] 0088-2160_5a636d73-c518-47c2-95f5-3d8925335681 0088-2160 HUMAN PRESCRIPTION DRUG Arava leflunomide TABLET, FILM COATED ORAL 19980910 NDA NDA020905 sanofi-aventis U.S. LLC LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] 0088-2161_5a636d73-c518-47c2-95f5-3d8925335681 0088-2161 HUMAN PRESCRIPTION DRUG Arava leflunomide TABLET, FILM COATED ORAL 19980910 NDA NDA020905 sanofi-aventis U.S. LLC LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] 0088-2162_5a636d73-c518-47c2-95f5-3d8925335681 0088-2162 HUMAN PRESCRIPTION DRUG Arava leflunomide TABLET, FILM COATED ORAL 19980919 NDA NDA020905 sanofi-aventis U.S. LLC LEFLUNOMIDE 100 mg/1 Antirheumatic Agent [EPC] 0088-2219_41e78e34-6718-46f1-ba91-a00e65a1e5f1 0088-2219 HUMAN PRESCRIPTION DRUG Lantus Solostar insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20090923 NDA NDA021081 sanofi-aventis U.S. LLC INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0088-2220_41e78e34-6718-46f1-ba91-a00e65a1e5f1 0088-2220 HUMAN PRESCRIPTION DRUG Lantus insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20090923 NDA NDA021081 sanofi-aventis U.S. LLC INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0088-2223_6f759736-f006-41fc-a744-c31418254573 0088-2223 HUMAN PRESCRIPTION DRUG Ketek telithromycin TABLET, FILM COATED ORAL 20100601 NDA NDA021144 sanofi-aventis U.S. LLC TELITHROMYCIN 300 mg/1 Ketolide Antibacterial [EPC],Ketolides [Chemical/Ingredient] 0088-2225_6f759736-f006-41fc-a744-c31418254573 0088-2225 HUMAN PRESCRIPTION DRUG Ketek telithromycin TABLET, FILM COATED ORAL 20100601 NDA NDA021144 sanofi-aventis U.S. LLC TELITHROMYCIN 400 mg/1 Ketolide Antibacterial [EPC],Ketolides [Chemical/Ingredient] 0088-2500_e8cc5c71-18e6-4013-ab32-8bc55bd95d44 0088-2500 HUMAN PRESCRIPTION DRUG Apidra insulin glulisine INJECTION, SOLUTION SUBCUTANEOUS 20090224 NDA NDA021629 Sanofi-Aventis U.S. LLC INSULIN GLULISINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0088-2502_e8cc5c71-18e6-4013-ab32-8bc55bd95d44 0088-2502 HUMAN PRESCRIPTION DRUG Apidra SoloStar insulin glulisine INJECTION, SOLUTION SUBCUTANEOUS 20090224 NDA NDA021629 Sanofi-Aventis U.S. LLC INSULIN GLULISINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 00904-5899_1340298f-2e7b-4993-8122-6b0d08241c5a 00904-5899 HUMAN OTC DRUG Major Oral Pain Relief Maximum Strength Oral Anesthetic LIQUID ORAL 20080801 OTC MONOGRAPH FINAL part356 Major Pharmaceuticals BENZOCAINE 200 mg/mL 00904-7851_1daa463f-7e91-47cb-a16d-7a95ca295b2e 00904-7851 HUMAN OTC DRUG Major Camphor and Phenol Antiseptic LIQUID TOPICAL 20080509 OTC MONOGRAPH FINAL part348 Major Pharmaceuticals CAMPHOR (SYNTHETIC); PHENOL 10.8; 4.7 g/100mL; g/100mL 0091-2489_911d2066-26ee-494b-ac35-9fe4c793e911 0091-2489 HUMAN PRESCRIPTION DRUG VERELAN verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 UCB, Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0091-2490_911d2066-26ee-494b-ac35-9fe4c793e911 0091-2490 HUMAN PRESCRIPTION DRUG VERELAN verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 UCB, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0091-2491_911d2066-26ee-494b-ac35-9fe4c793e911 0091-2491 HUMAN PRESCRIPTION DRUG VERELAN verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 UCB, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0091-2495_911d2066-26ee-494b-ac35-9fe4c793e911 0091-2495 HUMAN PRESCRIPTION DRUG VERELAN verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 UCB, Inc. VERAPAMIL HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0091-3321_9f72e288-cf78-4ebf-a999-0e1bbbb0d119 0091-3321 HUMAN PRESCRIPTION DRUG Niravam alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20050120 NDA NDA021726 Schwarz Pharma Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0091-3322_9f72e288-cf78-4ebf-a999-0e1bbbb0d119 0091-3322 HUMAN PRESCRIPTION DRUG Niravam alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20050120 NDA NDA021726 Schwarz Pharma Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0091-3323_9f72e288-cf78-4ebf-a999-0e1bbbb0d119 0091-3323 HUMAN PRESCRIPTION DRUG Niravam alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20050120 NDA NDA021726 Schwarz Pharma Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0091-3324_9f72e288-cf78-4ebf-a999-0e1bbbb0d119 0091-3324 HUMAN PRESCRIPTION DRUG Niravam alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20050120 NDA NDA021726 Schwarz Pharma Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0091-3707_ec8857ca-39a4-47ba-868c-dfb38ac04eec 0091-3707 HUMAN PRESCRIPTION DRUG Univasc moexipril hydrochloride TABLET, FILM COATED ORAL 19950715 NDA NDA020312 UCB, Inc. MOEXIPRIL HYDROCHLORIDE 7.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0091-3712_3f3f9376-9e54-40d9-82ba-9010a4ad982f 0091-3712 HUMAN PRESCRIPTION DRUG Uniretic moexipril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 19970915 NDA NDA020729 UCB, Inc. HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5; 7.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0091-3715_ec8857ca-39a4-47ba-868c-dfb38ac04eec 0091-3715 HUMAN PRESCRIPTION DRUG Univasc moexipril hydrochloride TABLET, FILM COATED ORAL 19950715 NDA NDA020312 UCB, Inc. MOEXIPRIL HYDROCHLORIDE 15 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0091-3720_3f3f9376-9e54-40d9-82ba-9010a4ad982f 0091-3720 HUMAN PRESCRIPTION DRUG Uniretic moexipril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20020215 NDA NDA020729 UCB, Inc. HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5; 15 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0091-3725_3f3f9376-9e54-40d9-82ba-9010a4ad982f 0091-3725 HUMAN PRESCRIPTION DRUG Uniretic moexipril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 19970915 NDA NDA020729 UCB, Inc. HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 25; 15 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0091-4085_c51ec9b1-3c59-4498-bc30-79e4ebaa9bc2 0091-4085 HUMAN PRESCRIPTION DRUG VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 UCB, Inc. VERAPAMIL HYDROCHLORIDE 100 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0091-4086_c51ec9b1-3c59-4498-bc30-79e4ebaa9bc2 0091-4086 HUMAN PRESCRIPTION DRUG VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 UCB, Inc. VERAPAMIL HYDROCHLORIDE 200 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0091-4087_c51ec9b1-3c59-4498-bc30-79e4ebaa9bc2 0091-4087 HUMAN PRESCRIPTION DRUG VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 UCB, Inc. VERAPAMIL HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0091-4500_e6fd62bb-4643-401a-90ef-471d6dbb6c16 0091-4500 HUMAN PRESCRIPTION DRUG Levatol penbutolol sulfate TABLET ORAL 19950615 NDA NDA018976 UCB, Inc. PENBUTOLOL SULFATE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0091-6701_f27f9efd-87cb-4e4a-b207-78108f2059c4 0091-6701 HUMAN PRESCRIPTION DRUG Reglan metoclopramide hydrochloride TABLET ORAL 20030505 NDA NDA017854 UCB, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0091-6705_f27f9efd-87cb-4e4a-b207-78108f2059c4 0091-6705 HUMAN PRESCRIPTION DRUG Reglan metoclopramide hydrochloride TABLET ORAL 20030619 NDA NDA017854 UCB, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0091-7429_d88de2b1-e3b0-4bcb-8bd6-90c21b21fbd9 0091-7429 HUMAN PRESCRIPTION DRUG Robaxin Methocarbamol TABLET, FILM COATED ORAL 20030115 NDA NDA011011 Schwarz Pharma Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0091-7449_d88de2b1-e3b0-4bcb-8bd6-90c21b21fbd9 0091-7449 HUMAN PRESCRIPTION DRUG Robaxin Methocarbamol TABLET, FILM COATED ORAL 20030120 NDA NDA011011 Schwarz Pharma Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0093-0011_cc6317a0-f22f-4859-bbb9-ed6da03921fe 0093-0011 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071221 ANDA ANDA077056 Teva Pharmaceuticals USA Inc PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0093-0012_cc6317a0-f22f-4859-bbb9-ed6da03921fe 0093-0012 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071219 ANDA ANDA077056 Teva Pharmaceuticals USA Inc PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0093-0017_2fca5cf6-f0a0-42a4-9485-de56f6ac8dbe 0093-0017 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET, FILM COATED ORAL 20030508 ANDA ANDA076204 Teva Pharmaceuticals USA Inc MOEXIPRIL HYDROCHLORIDE 7.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0093-0026_3c3c0613-0a30-413c-a036-d60da2c4147f 0093-0026 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000823 ANDA ANDA075479 Teva Pharmaceuticals USA Inc ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0093-0027_3c3c0613-0a30-413c-a036-d60da2c4147f 0093-0027 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000823 ANDA ANDA075479 Teva Pharmaceuticals USA Inc ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0093-0028_3c3c0613-0a30-413c-a036-d60da2c4147f 0093-0028 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000823 ANDA ANDA075479 Teva Pharmaceuticals USA Inc ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0093-0029_3c3c0613-0a30-413c-a036-d60da2c4147f 0093-0029 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000823 ANDA ANDA075479 Teva Pharmaceuticals USA Inc ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0093-0039_c9e57ca5-e493-4c48-98c4-a34b75a365dc 0093-0039 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20080722 ANDA ANDA076388 Teva Pharmaceuticals USA Inc LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0093-0041_dba43208-815a-4159-8578-a3a0e70b804e 0093-0041 HUMAN PRESCRIPTION DRUG ClomiPHENE Citrate ClomiPHENE citrate TABLET ORAL 19921101 NDA AUTHORIZED GENERIC NDA018361 Teva Pharmaceuticals USA Inc CLOMIPHENE CITRATE 50 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 0093-0050_6334c49b-9ce1-47d6-a729-a93f391406a2 0093-0050 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19900930 ANDA ANDA088627 Teva Pharmaceuticals USA Inc ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0093-0051_b186b5ce-431f-4219-94f4-302594f3125e 0093-0051 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070906 ANDA ANDA076373 Teva Pharmaceuticals USA Inc CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0093-0053_77aba923-3a73-421f-bbad-ae6aee683773 0093-0053 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020228 ANDA ANDA075022 Teva Pharmaceuticals USA Inc BUSPIRONE HYDROCHLORIDE 5 mg/1 0093-0054_77aba923-3a73-421f-bbad-ae6aee683773 0093-0054 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020228 ANDA ANDA075022 Teva Pharmaceuticals USA Inc BUSPIRONE HYDROCHLORIDE 10 mg/1 0093-0058_b0f07428-46e8-461d-aa69-d4cf07f32b80 0093-0058 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED ORAL 20020620 ANDA ANDA075977 Teva Pharmaceuticals USA Inc TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 0093-0064_8470974b-92e9-4f41-8019-9e8ba2509ed5 0093-0064 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole Sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA076822 Teva Pharmaceuticals USA Inc RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0093-0073_45c7c4fe-4fc4-45d3-8f35-29ff5cb369c5 0093-0073 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076410 Teva Pharmaceuticals USA Inc ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0093-0074_45c7c4fe-4fc4-45d3-8f35-29ff5cb369c5 0093-0074 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076410 Teva Pharmaceuticals USA Inc ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0093-0083_1005c6bc-abb5-47dd-a334-a3f22b4d5c3c 0093-0083 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070710 ANDA ANDA076846 Teva Pharmaceuticals USA Inc AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0093-0088_599eb2bc-bea3-4fe3-8dd4-c47b1da1f021 0093-0088 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 19900930 ANDA ANDA070030 Teva Pharmaceuticals USA Inc SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0093-0089_599eb2bc-bea3-4fe3-8dd4-c47b1da1f021 0093-0089 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim (Double Strength) Sulfamethoxazole and Trimethoprim TABLET ORAL 19900930 ANDA ANDA070037 Teva Pharmaceuticals USA Inc SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0093-0090_a1def148-d525-4cce-9eec-76591971187b 0093-0090 HUMAN PRESCRIPTION DRUG Epitol Carbamazepine TABLET ORAL 19900930 ANDA ANDA070541 Teva Pharmaceuticals USA Inc CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0093-0109_4657f90b-f723-4e8e-8673-02f4f27da9ff 0093-0109 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19900930 ANDA ANDA070541 Teva Pharmaceuticals USA Inc CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0093-0129_5b6b788b-42ed-477c-8aa5-428a95eb22c4 0093-0129 HUMAN PRESCRIPTION DRUG Estazolam Estazolam TABLET ORAL 19970714 ANDA ANDA074921 Teva Pharmaceuticals USA Inc ESTAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0093-0130_5b6b788b-42ed-477c-8aa5-428a95eb22c4 0093-0130 HUMAN PRESCRIPTION DRUG Estazolam Estazolam TABLET ORAL 19970714 ANDA ANDA074921 Teva Pharmaceuticals USA Inc ESTAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0093-0132_b7e65908-3686-4286-b020-e488a29397b3 0093-0132 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20060629 ANDA ANDA076420 Teva Pharmaceuticals USA Inc LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0093-0135_b186b5ce-431f-4219-94f4-302594f3125e 0093-0135 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070906 ANDA ANDA076373 Teva Pharmaceuticals USA Inc CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0093-0147_313c3462-ed11-421d-8fc4-f171def47fce 0093-0147 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 19931222 ANDA ANDA074201 Teva Pharmaceuticals USA Inc NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-0148_313c3462-ed11-421d-8fc4-f171def47fce 0093-0148 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 19931222 ANDA ANDA074201 Teva Pharmaceuticals USA Inc NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-0149_313c3462-ed11-421d-8fc4-f171def47fce 0093-0149 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 19931222 ANDA ANDA074201 Teva Pharmaceuticals USA Inc NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-0150_6334c49b-9ce1-47d6-a729-a93f391406a2 0093-0150 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19900930 ANDA ANDA088628 Teva Pharmaceuticals USA Inc ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0093-0154_9eb85706-4a4a-441f-9fa7-b06ccd4c3c59 0093-0154 HUMAN PRESCRIPTION DRUG Ticlopidine Hydrochloride Ticlopidine Hydrochloride TABLET, FILM COATED ORAL 19990907 ANDA ANDA075149 Teva Pharmaceuticals USA Inc TICLOPIDINE HYDROCHLORIDE 250 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0093-0155_8251c4c2-9c4a-4a5c-afdc-eba2811bf48f 0093-0155 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20090331 ANDA ANDA076317 Teva Pharmaceuticals USA Inc TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0093-0173_d5b7c6ef-43b9-4058-936f-6f8ced6b003a 0093-0173 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET, FILM COATED ORAL 20050914 ANDA ANDA077084 Teva Pharmaceuticals USA Inc LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] 0093-0174_d5b7c6ef-43b9-4058-936f-6f8ced6b003a 0093-0174 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET, FILM COATED ORAL 20050914 ANDA ANDA077084 Teva Pharmaceuticals USA Inc LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] 0093-0199_36292521-33b7-4167-97e3-40bdf91c8970 0093-0199 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20060804 ANDA ANDA076690 Teva Pharmaceuticals USA Inc VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-0220_89e39874-c015-4332-bec6-37f152102bff 0093-0220 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20090706 ANDA ANDA076932 Teva Pharmaceuticals USA Inc BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 0093-0233_0f611c9e-16b0-4bf2-b237-80142542fb29 0093-0233 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070703 ANDA ANDA076252 Teva Pharmaceuticals USA Inc ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0093-0248_2833ade2-1e46-4af4-8e71-45d0608e08db 0093-0248 HUMAN PRESCRIPTION DRUG Clotrimazole Clotrimazole SOLUTION TOPICAL 19960710 ANDA ANDA073306 Teva Pharmaceuticals USA Inc CLOTRIMAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0093-0262_deb5e6d4-4008-4c2f-a420-89e61b2460ff 0093-0262 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19900930 ANDA ANDA072488 Teva Pharmaceuticals USA Inc FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0093-0263_deb5e6d4-4008-4c2f-a420-89e61b2460ff 0093-0263 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19900930 ANDA ANDA072490 Teva Pharmaceuticals USA Inc FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0093-0264_deb5e6d4-4008-4c2f-a420-89e61b2460ff 0093-0264 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide OINTMENT TOPICAL 19920501 ANDA ANDA073481 Teva Pharmaceuticals USA Inc FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0093-0265_deb5e6d4-4008-4c2f-a420-89e61b2460ff 0093-0265 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide GEL TOPICAL 19900930 ANDA ANDA072537 Teva Pharmaceuticals USA Inc FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0093-0292_47b082f4-a99e-400b-97a8-f054120d1671 0093-0292 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19930301 ANDA ANDA073618 Teva Pharmaceuticals USA Inc CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0093-0293_47b082f4-a99e-400b-97a8-f054120d1671 0093-0293 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19930401 ANDA ANDA073589 Teva Pharmaceuticals USA Inc CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0093-0294_47b082f4-a99e-400b-97a8-f054120d1671 0093-0294 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19930101 ANDA ANDA073607 Teva Pharmaceuticals USA Inc CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0093-0308_65028f6e-f472-411f-a1b6-01795959f561 0093-0308 HUMAN PRESCRIPTION DRUG Clemastine Fumarate Clemastine Fumarate TABLET ORAL 19920401 ANDA ANDA073283 Teva Pharmaceuticals USA Inc CLEMASTINE FUMARATE 2.68 mg/1 0093-0309_ba83cf20-12a4-4542-a5e7-a2a0a1da6457 0093-0309 HUMAN PRESCRIPTION DRUG Clemastine Fumarate Clemastine Fumarate SYRUP ORAL 19950329 ANDA ANDA073399 Teva Pharmaceuticals USA Inc CLEMASTINE FUMARATE .5 mg/5mL 0093-0311_d09e19c3-65ac-49a9-b98a-25fd473c060f 0093-0311 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA073192 Teva Pharmaceuticals USA Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 0093-0314_8d49fd63-db80-46fb-892c-0662d748550d 0093-0314 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 19980617 ANDA ANDA074754 Teva Pharmaceuticals USA Inc KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-0318_d65c5f7f-e3de-4349-ad59-07ed8984cba7 0093-0318 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Teva Pharmaceuticals USA Inc DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0093-0319_d65c5f7f-e3de-4349-ad59-07ed8984cba7 0093-0319 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Teva Pharmaceuticals USA Inc DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0093-0320_d65c5f7f-e3de-4349-ad59-07ed8984cba7 0093-0320 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Teva Pharmaceuticals USA Inc DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0093-0321_d65c5f7f-e3de-4349-ad59-07ed8984cba7 0093-0321 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951226 ANDA ANDA074185 Teva Pharmaceuticals USA Inc DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0093-0350_6334c49b-9ce1-47d6-a729-a93f391406a2 0093-0350 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19900930 ANDA ANDA088629 Teva Pharmaceuticals USA Inc ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0093-0463_c9e57ca5-e493-4c48-98c4-a34b75a365dc 0093-0463 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20080722 ANDA ANDA076388 Teva Pharmaceuticals USA Inc LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0093-0536_1ca74648-7ef2-401c-98b7-abe62656e6b1 0093-0536 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 19931222 ANDA ANDA074198 Teva Pharmaceuticals USA Inc NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-0537_1ca74648-7ef2-401c-98b7-abe62656e6b1 0093-0537 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 19931222 ANDA ANDA074198 Teva Pharmaceuticals USA Inc NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-0576_636ad30b-5b10-4749-88ce-dc3152fe944b 0093-0576 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075551 Teva Pharmaceuticals USA Inc LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0093-0657_95aa72d1-53d4-489f-b581-34fb744d8d0c 0093-0657 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20011015 ANDA ANDA075765 Teva Pharmaceuticals USA Inc CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0093-0658_95aa72d1-53d4-489f-b581-34fb744d8d0c 0093-0658 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20011015 ANDA ANDA075765 Teva Pharmaceuticals USA Inc CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0093-0661_c43d014e-afae-46a2-be4b-f012c76c0bb0 0093-0661 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP ORAL 19920501 ANDA ANDA073419 Teva Pharmaceuticals USA Inc ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0093-0670_446c9ce4-8be8-48b9-8737-da556bec0bb2 0093-0670 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19931124 ANDA ANDA074256 Teva Pharmaceuticals USA Inc GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0093-0688_b7e65908-3686-4286-b020-e488a29397b3 0093-0688 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20060828 ANDA ANDA076420 Teva Pharmaceuticals USA Inc LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0093-0711_615cb35c-8b9c-4c24-94e9-acb4fd2633f8 0093-0711 HUMAN PRESCRIPTION DRUG Flurbiprofen Flurbiprofen TABLET, FILM COATED ORAL 19950602 ANDA ANDA074431 Teva Pharmaceuticals USA Inc FLURBIPROFEN 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-0733_a302d9b2-a3f6-475f-b28a-df549966aad3 0093-0733 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 19950406 ANDA ANDA074141 Teva Pharmaceuticals USA Inc METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0093-0734_a302d9b2-a3f6-475f-b28a-df549966aad3 0093-0734 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 19950406 ANDA ANDA074141 Teva Pharmaceuticals USA Inc METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0093-0738_797a7a46-f54a-4ef3-9a2e-c5bc31e063fe 0093-0738 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110531 20151031 ANDA ANDA090425 Teva Pharmaceuticals USA Inc DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0093-0739_797a7a46-f54a-4ef3-9a2e-c5bc31e063fe 0093-0739 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110531 20150731 ANDA ANDA090425 Teva Pharmaceuticals USA Inc DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0093-0752_7e76b2a6-b16d-4667-91d2-a5c811f5b8ca 0093-0752 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950222 ANDA ANDA074056 Teva Pharmaceuticals USA Inc ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0093-0753_7e76b2a6-b16d-4667-91d2-a5c811f5b8ca 0093-0753 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950217 ANDA ANDA074056 Teva Pharmaceuticals USA Inc ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0093-0755_b889ad3b-a7c8-4bd8-8f3c-ec0cd5f2806f 0093-0755 HUMAN PRESCRIPTION DRUG Diflunisal Diflunisal TABLET, FILM COATED ORAL 19921101 ANDA ANDA073673 Teva Pharmaceuticals USA Inc DIFLUNISAL 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-0756_676506d5-2bec-4e37-9a27-f1044b36de6b 0093-0756 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 19941019 ANDA ANDA074131 Teva Pharmaceuticals USA Inc PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-0757_676506d5-2bec-4e37-9a27-f1044b36de6b 0093-0757 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 19940126 ANDA ANDA074131 Teva Pharmaceuticals USA Inc PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-0771_d85e5a03-381d-4a3e-9cd0-f97ced630300 0093-0771 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20060425 ANDA ANDA076056 Teva Pharmaceuticals USA Inc PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0093-0778_4657f90b-f723-4e8e-8673-02f4f27da9ff 0093-0778 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, CHEWABLE ORAL 19950918 ANDA ANDA073524 Teva Pharmaceuticals USA Inc CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0093-0782_e3503377-5756-46f4-9465-14f9fb786826 0093-0782 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20030221 ANDA ANDA074858 Teva Pharmaceuticals USA Inc TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 0093-0784_e3503377-5756-46f4-9465-14f9fb786826 0093-0784 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20030220 ANDA ANDA075797 Teva Pharmaceuticals USA Inc TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 0093-0787_7e76b2a6-b16d-4667-91d2-a5c811f5b8ca 0093-0787 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20041116 ANDA ANDA074056 Teva Pharmaceuticals USA Inc ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0093-0810_48df30ec-294f-4179-b284-383b6435b977 0093-0810 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Teva Pharmaceuticals USA Inc NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0093-0811_48df30ec-294f-4179-b284-383b6435b977 0093-0811 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950406 ANDA ANDA074132 Teva Pharmaceuticals USA Inc NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0093-0812_48df30ec-294f-4179-b284-383b6435b977 0093-0812 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Teva Pharmaceuticals USA Inc NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0093-0813_48df30ec-294f-4179-b284-383b6435b977 0093-0813 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Teva Pharmaceuticals USA Inc NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 0093-0819_2a4f333b-0dfe-4762-8fee-94e7f4242bb3 0093-0819 HUMAN PRESCRIPTION DRUG Nifedical XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20010209 ANDA ANDA075289 Teva Pharmaceuticals USA Inc NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0093-0832_d6db2ac2-93f8-4d95-915a-ed5fa80a023a 0093-0832 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960918 ANDA ANDA074569 Teva Pharmaceuticals USA Inc CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0093-0833_d6db2ac2-93f8-4d95-915a-ed5fa80a023a 0093-0833 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960917 ANDA ANDA074569 Teva Pharmaceuticals USA Inc CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0093-0834_d6db2ac2-93f8-4d95-915a-ed5fa80a023a 0093-0834 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960918 ANDA ANDA074569 Teva Pharmaceuticals USA Inc CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0093-0840_42c3397a-c894-4f0c-af40-9dcabc0ae926 0093-0840 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20000427 ANDA ANDA075581 Teva Pharmaceuticals USA Inc KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0093-0892_0418f6ee-bc12-4645-91e5-310f531c8fe4 0093-0892 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980520 ANDA ANDA075009 Teva Pharmaceuticals USA Inc ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-0900_1e0cf120-8a49-4d12-9d3d-e04fcc6ad147 0093-0900 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615 ANDA ANDA075273 Teva Pharmaceuticals USA Inc KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0093-0924_e7b816b2-ab4d-45af-87df-6b7f9bc203c8 0093-0924 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20030512 ANDA ANDA075849 Teva Pharmaceuticals USA Inc OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-0926_636ad30b-5b10-4749-88ce-dc3152fe944b 0093-0926 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075551 Teva Pharmaceuticals USA Inc LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0093-0928_636ad30b-5b10-4749-88ce-dc3152fe944b 0093-0928 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075551 Teva Pharmaceuticals USA Inc LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0093-0948_a5509855-5fcf-4227-be45-e3bbf926a3f5 0093-0948 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19980811 ANDA ANDA075219 Teva Pharmaceuticals USA Inc DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-0983_28415493-e4d9-4d63-a557-9ee7d9433fdd 0093-0983 HUMAN PRESCRIPTION DRUG Nystatin Nystatin TABLET, FILM COATED ORAL 19900930 ANDA ANDA062506 Teva Pharmaceuticals USA Inc NYSTATIN 500000 [USP'U]/1 Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 0093-1003_77aba923-3a73-421f-bbad-ae6aee683773 0093-1003 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020301 ANDA ANDA075022 Teva Pharmaceuticals USA Inc BUSPIRONE HYDROCHLORIDE 15 mg/1 0093-1005_53a5bc28-6887-4e5a-813f-8421536c0b64 0093-1005 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 19980731 ANDA ANDA075227 Teva Pharmaceuticals USA Inc NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-1006_53a5bc28-6887-4e5a-813f-8421536c0b64 0093-1006 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 19980729 ANDA ANDA075227 Teva Pharmaceuticals USA Inc NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-1010_ca6bd3d9-d7c1-4bed-9b66-b12690c5eb47 0093-1010 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20031107 ANDA ANDA065085 Teva Pharmaceuticals USA Inc MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 0093-1015_6ef5de86-f3ac-4dc4-9d4e-c1e94713bb7c 0093-1015 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20010820 ANDA ANDA075189 Teva Pharmaceuticals USA Inc NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-1016_6ef5de86-f3ac-4dc4-9d4e-c1e94713bb7c 0093-1016 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20010926 ANDA ANDA075189 Teva Pharmaceuticals USA Inc NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-1024_75d6633e-1f1d-46cd-baec-d8a91c223df9 0093-1024 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Teva Pharmaceuticals USA Inc NEFAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 0093-1025_75d6633e-1f1d-46cd-baec-d8a91c223df9 0093-1025 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Teva Pharmaceuticals USA Inc NEFAZODONE HYDROCHLORIDE 200 mg/1 Serotonin Reuptake Inhibitor [EPC] 0093-1026_75d6633e-1f1d-46cd-baec-d8a91c223df9 0093-1026 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Teva Pharmaceuticals USA Inc NEFAZODONE HYDROCHLORIDE 250 mg/1 Serotonin Reuptake Inhibitor [EPC] 0093-1041_c2855478-5678-4c86-94e9-e57390c324eb 0093-1041 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000228 ANDA ANDA075492 TEVA Pharmaceuticals USA Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-1044_15a72455-2895-4783-8c0a-52017e83d772 0093-1044 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleate and Hydrochlorothiazide TABLET ORAL 20010919 ANDA ANDA075727 Teva Pharmaceuticals USA Inc ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 5; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0093-1048_0ce4d94c-3472-4839-967b-45e845290a36 0093-1048 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020128 ANDA ANDA075978 Teva Pharmaceuticals USA Inc METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0093-1049_0ce4d94c-3472-4839-967b-45e845290a36 0093-1049 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020211 ANDA ANDA075978 Teva Pharmaceuticals USA Inc METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0093-1052_15a72455-2895-4783-8c0a-52017e83d772 0093-1052 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleate and Hydrochlorothiazide TABLET ORAL 20010919 ANDA ANDA075727 Teva Pharmaceuticals USA Inc ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0093-1060_ce2aaec4-9210-46ff-a9a0-cb0bd717c954 0093-1060 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20000505 ANDA ANDA075429 Teva Pharmaceuticals USA Inc SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC] 0093-1061_ce2aaec4-9210-46ff-a9a0-cb0bd717c954 0093-1061 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20000504 ANDA ANDA075429 Teva Pharmaceuticals USA Inc SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 0093-1062_ce2aaec4-9210-46ff-a9a0-cb0bd717c954 0093-1062 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20000505 ANDA ANDA075429 Teva Pharmaceuticals USA Inc SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC] 0093-1063_ce2aaec4-9210-46ff-a9a0-cb0bd717c954 0093-1063 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20000505 ANDA ANDA075429 Teva Pharmaceuticals USA Inc SOTALOL HYDROCHLORIDE 240 mg/1 Antiarrhythmic [EPC] 0093-1075_a23a103f-43ff-4e2e-8e0c-7b0a01794d10 0093-1075 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20060304 ANDA ANDA065236 Teva Pharmaceuticals USA Inc CEFPROZIL 125 mg/5mL 0093-1076_a23a103f-43ff-4e2e-8e0c-7b0a01794d10 0093-1076 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20051223 ANDA ANDA065236 Teva Pharmaceuticals USA Inc CEFPROZIL 250 mg/5mL 0093-1077_8b8b21e7-4d8f-4992-b36a-d7857706a827 0093-1077 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20051223 ANDA ANDA065208 Teva Pharmaceuticals USA Inc CEFPROZIL 250 mg/1 0093-1078_8b8b21e7-4d8f-4992-b36a-d7857706a827 0093-1078 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20051223 ANDA ANDA065208 Teva Pharmaceuticals USA Inc CEFPROZIL 500 mg/1 0093-1087_5c479eda-031e-4097-ae8b-62b6d1b19181 0093-1087 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020926 ANDA ANDA065058 Teva Pharmaceuticals USA Inc CEFACLOR 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0093-1118_45516aef-46cc-46bd-a506-3a33ed033534 0093-1118 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000817 ANDA ANDA075665 Teva Pharmaceuticals USA Inc ETODOLAC 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-1122_45516aef-46cc-46bd-a506-3a33ed033534 0093-1122 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20010209 ANDA ANDA075665 Teva Pharmaceuticals USA Inc ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-1135_8a3ae735-a24f-4c8e-8ab1-4138a547e2e0 0093-1135 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20130719 ANDA ANDA091455 Teva Pharmaceuticals USA Inc ACITRETIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 0093-1136_8a3ae735-a24f-4c8e-8ab1-4138a547e2e0 0093-1136 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20130719 ANDA ANDA091455 Teva Pharmaceuticals USA Inc ACITRETIN 25 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 0093-1138_8a3ae735-a24f-4c8e-8ab1-4138a547e2e0 0093-1138 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20130719 ANDA ANDA202897 Teva Pharmaceuticals USA Inc ACITRETIN 17.5 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 0093-1172_a993a059-e57f-471c-84da-acb642075a40 0093-1172 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 19900930 ANDA ANDA060711 Teva Pharmaceuticals USA Inc PENICILLIN V POTASSIUM 250 mg/1 0093-1174_a993a059-e57f-471c-84da-acb642075a40 0093-1174 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 19900930 ANDA ANDA060711 Teva Pharmaceuticals USA Inc PENICILLIN V POTASSIUM 500 mg/1 0093-1177_ac986dd9-08bf-43fc-82bd-b27c3133f233 0093-1177 HUMAN PRESCRIPTION DRUG Neomycin Sulfate Neomycin Sulfate TABLET ORAL 19900930 ANDA ANDA060304 Teva Pharmaceuticals USA Inc NEOMYCIN SULFATE 500 mg/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0093-1389_d31b4852-4c99-42e5-afe2-36f4cbb27167 0093-1389 HUMAN PRESCRIPTION DRUG Cromolyn Sodium cromolyn sodium SOLUTION/ DROPS OPHTHALMIC 19980526 ANDA ANDA074443 Teva Pharmaceuticals USA Inc. CROMOLYN SODIUM 40 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] 0093-1893_0418f6ee-bc12-4645-91e5-310f531c8fe4 0093-1893 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20090909 ANDA ANDA075009 Teva Pharmaceuticals USA Inc ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-2026_0f25cd2f-ba51-4ebf-a422-0fcb22be5d88 0093-2026 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20101217 ANDA ANDA065246 Teva Pharmaceuticals USA Inc AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0093-2027_0f25cd2f-ba51-4ebf-a422-0fcb22be5d88 0093-2027 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20101228 ANDA ANDA065246 Teva Pharmaceuticals USA Inc AZITHROMYCIN MONOHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0093-2046_3c52f60a-9068-4606-8056-02cebd614d74 0093-2046 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 Teva Pharmaceuticals USA Inc PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0093-2047_3c52f60a-9068-4606-8056-02cebd614d74 0093-2047 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 Teva Pharmaceuticals USA Inc PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0093-2048_3c52f60a-9068-4606-8056-02cebd614d74 0093-2048 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 Teva Pharmaceuticals USA Inc PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0093-2049_221604d4-e944-4e90-87a3-e50fc457d962 0093-2049 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20140102 NDA AUTHORIZED GENERIC NDA021228 Teva Pharmaceuticals USA Inc TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0093-2050_221604d4-e944-4e90-87a3-e50fc457d962 0093-2050 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20140102 NDA AUTHORIZED GENERIC NDA021228 Teva Pharmaceuticals USA Inc TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0093-2055_db6a1c57-99da-4739-82db-e249de780583 0093-2055 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate TABLET, FILM COATED ORAL 20120511 NDA NDA020771 TEVA Pharmaceuticals USA Inc TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0093-2056_db6a1c57-99da-4739-82db-e249de780583 0093-2056 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate TABLET, FILM COATED ORAL 20120511 NDA NDA020771 TEVA Pharmaceuticals USA Inc TOLTERODINE TARTRATE 1 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0093-2057_01cb6971-52c2-4325-b2af-ba5358148d75 0093-2057 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20121018 ANDA ANDA075269 TEVA PHARMACEUTICALS USA NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0093-2058_1a105a59-dcd5-4fa6-a675-995d6ab5c58d 0093-2058 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20121108 ANDA ANDA075269 TEVA PHARMACEUTICALS USA NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0093-2059_03d4e97e-a5fd-4131-a5dd-56fb0268a074 0093-2059 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20130802 ANDA ANDA076070 TEVA PHARMACEUTICALS USA NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0093-2060_dfc2b92a-2259-b233-a67e-97e2a21d3b9e 0093-2060 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20041105 NDA AUTHORIZED GENERIC NDA021656 Teva Pharmaceuticals USA Inc FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0093-2061_dfc2b92a-2259-b233-a67e-97e2a21d3b9e 0093-2061 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20041105 NDA AUTHORIZED GENERIC NDA021656 Teva Pharmaceuticals USA Inc FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0093-2063_8bd44d47-53c8-4e20-b827-dbca04bcc3f7 0093-2063 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20130717 ANDA ANDA077745 Teva Pharmaceuticals USA Inc QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 0093-2064_4d492d98-9306-4c8a-8f77-48bc0b51525e 0093-2064 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20121024 ANDA ANDA077027 Teva Pharmaceuticals USA Inc CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0093-2065_4d492d98-9306-4c8a-8f77-48bc0b51525e 0093-2065 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20120424 ANDA ANDA077027 Teva Pharmaceuticals USA Inc CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0093-2067_e23f5217-0b77-4e2d-b419-335c649a3739 0093-2067 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20130329 ANDA ANDA075536 Teva Pharmaceuticals USA Inc DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0093-2068_e23f5217-0b77-4e2d-b419-335c649a3739 0093-2068 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20130329 ANDA ANDA075536 Teva Pharmaceuticals USA Inc DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0093-2069_e23f5217-0b77-4e2d-b419-335c649a3739 0093-2069 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20130329 ANDA ANDA075536 Teva Pharmaceuticals USA Inc DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0093-2070_e23f5217-0b77-4e2d-b419-335c649a3739 0093-2070 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20130329 ANDA ANDA075536 Teva Pharmaceuticals USA Inc DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0093-2075_e7185968-584c-4b36-aae8-fc7b546e715f 0093-2075 HUMAN PRESCRIPTION DRUG Tolmetin Sodium Tolmetin Sodium CAPSULE ORAL 20120726 ANDA ANDA073290 Teva Pharmaceuticals USA Inc TOLMETIN SODIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-2085_1e134990-e41c-4fa5-920c-8c18da002482 0093-2085 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide SPRAY, METERED NASAL 20110615 ANDA ANDA078104 Teva Pharmaceuticals USA Inc TRIAMCINOLONE ACETONIDE 55 ug/1 0093-2090_294afe54-ed37-46a3-9769-c9e4b20bdebb 0093-2090 HUMAN PRESCRIPTION DRUG ZEOSA norethindrone and ethinyl estradiol, and ferrous fumarate KIT 20110325 ANDA ANDA078965 Teva Pharmaceuticals USA Inc 0093-2109_4714a677-33ef-4a57-8925-98bb6d1f4d61 0093-2109 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20111003 ANDA ANDA090591 Teva Pharmaceuticals USA Inc PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0093-2110_4714a677-33ef-4a57-8925-98bb6d1f4d61 0093-2110 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20110309 ANDA ANDA090591 Teva Pharmaceuticals USA Inc PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0093-2130_0370b5b3-aebd-4fa7-b8ad-39bf6b60d750 0093-2130 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20070308 ANDA ANDA073671 Teva Pharmaceuticals USA Inc NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 0093-2131_0370b5b3-aebd-4fa7-b8ad-39bf6b60d750 0093-2131 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20070308 ANDA ANDA073652 Teva Pharmaceuticals USA Inc NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 0093-2158_8ec39e74-27c3-4823-84e0-9703ea091cf1 0093-2158 HUMAN PRESCRIPTION DRUG Trimethoprim Trimethoprim TABLET ORAL 19900930 NDA NDA018679 Teva Pharmaceuticals USA Inc TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0093-2203_caf7ec0e-ee80-479b-acbc-7446d36cab75 0093-2203 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 Teva Pharmaceuticals USA Inc METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0093-2204_caf7ec0e-ee80-479b-acbc-7446d36cab75 0093-2204 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19930701 ANDA ANDA072801 Teva Pharmaceuticals USA Inc METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0093-2210_4db8cb98-4335-464d-a3f1-1045f5e6f86b 0093-2210 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 19961111 ANDA ANDA070848 Teva Pharmaceuticals USA Inc SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 0093-2238_4d9aa03f-c465-4dd2-b361-70f46ca77770 0093-2238 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin TABLET ORAL 19900930 ANDA ANDA063023 Teva Pharmaceuticals USA Inc CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0093-2240_4d9aa03f-c465-4dd2-b361-70f46ca77770 0093-2240 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin TABLET ORAL 19900930 ANDA ANDA063024 Teva Pharmaceuticals USA Inc CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0093-2263_2ac1dd75-40fb-4723-90f3-c66d3c949014 0093-2263 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20001121 ANDA ANDA065056 Teva Pharmaceuticals USA Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0093-2264_2ac1dd75-40fb-4723-90f3-c66d3c949014 0093-2264 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20000926 ANDA ANDA065056 Teva Pharmaceuticals USA Inc AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0093-2267_7f926075-b631-427e-93de-30f0e893e657 0093-2267 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, CHEWABLE ORAL 19951001 ANDA ANDA064013 Teva Pharmaceuticals USA Inc AMOXICILLIN 125 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0093-2268_7f926075-b631-427e-93de-30f0e893e657 0093-2268 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, CHEWABLE ORAL 19930101 ANDA ANDA064013 Teva Pharmaceuticals USA Inc AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0093-2270_0192652d-27db-4bef-b42c-567d1e83a92a 0093-2270 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, CHEWABLE ORAL 20050322 ANDA ANDA065205 Teva Pharmaceuticals USA Inc AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0093-2272_0192652d-27db-4bef-b42c-567d1e83a92a 0093-2272 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, CHEWABLE ORAL 20050210 ANDA ANDA065205 Teva Pharmaceuticals USA Inc AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0093-2274_0192652d-27db-4bef-b42c-567d1e83a92a 0093-2274 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065101 Teva Pharmaceuticals USA Inc AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0093-2275_0192652d-27db-4bef-b42c-567d1e83a92a 0093-2275 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 Teva Pharmaceuticals USA Inc AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0093-2277_0192652d-27db-4bef-b42c-567d1e83a92a 0093-2277 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20050113 ANDA ANDA065089 Teva Pharmaceuticals USA Inc AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0093-2279_0192652d-27db-4bef-b42c-567d1e83a92a 0093-2279 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20050113 ANDA ANDA065089 Teva Pharmaceuticals USA Inc AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0093-2748_2a8cc600-4995-4279-b169-206d7ef8a93f 0093-2748 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20140515 ANDA ANDA075512 Teva Pharmaceuticals USA Inc FAMOTIDINE 10 mg/1 0093-2929_aaf9fb05-07ab-479e-8604-16c6aafd2fcd 0093-2929 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20090123 ANDA ANDA087056 Teva Pharmaceuticals USA Inc CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 0093-2931_2d56136a-9922-4bc6-84ea-d02556511783 0093-2931 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 20090223 ANDA ANDA070098 Teva Pharmaceuticals USA Inc METHYLDOPA 250 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0093-2932_2d56136a-9922-4bc6-84ea-d02556511783 0093-2932 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 20090428 ANDA ANDA070343 Teva Pharmaceuticals USA Inc METHYLDOPA 500 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0093-3002_0486a646-d108-48e9-95fe-a83ea9e5a473 0093-3002 HUMAN PRESCRIPTION DRUG Quinine Sulfate Quinine Sulfate CAPSULE ORAL 20120928 ANDA ANDA091661 Teva Pharmaceuticals USA Inc QUININE SULFATE 324 mg/1 Antimalarial [EPC] 0093-3010_4ca5ecb2-e072-43f9-a3d5-94d4ce5ca826 0093-3010 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET, ORALLY DISINTEGRATING ORAL 20120830 NDA AUTHORIZED GENERIC NDA021590 Teva Pharmaceuticals USA Inc CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] 0093-3011_4ca5ecb2-e072-43f9-a3d5-94d4ce5ca826 0093-3011 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET, ORALLY DISINTEGRATING ORAL 20120830 NDA AUTHORIZED GENERIC NDA021590 Teva Pharmaceuticals USA Inc CLOZAPINE 12.5 mg/1 Atypical Antipsychotic [EPC] 0093-3012_4ca5ecb2-e072-43f9-a3d5-94d4ce5ca826 0093-3012 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET, ORALLY DISINTEGRATING ORAL 20120830 NDA AUTHORIZED GENERIC NDA021590 Teva Pharmaceuticals USA Inc CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] 0093-3043_fa645492-03e3-4243-bdef-468ebebdeb96 0093-3043 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140310 ANDA ANDA074587 Teva Pharmaceuticals USA Inc VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0093-3044_fa645492-03e3-4243-bdef-468ebebdeb96 0093-3044 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140129 ANDA ANDA074587 Teva Pharmaceuticals USA Inc VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0093-3045_fa645492-03e3-4243-bdef-468ebebdeb96 0093-3045 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140407 ANDA ANDA074587 Teva Pharmaceuticals USA Inc VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0093-3107_7f926075-b631-427e-93de-30f0e893e657 0093-3107 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19900930 ANDA ANDA061926 Teva Pharmaceuticals USA Inc AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0093-3109_7f926075-b631-427e-93de-30f0e893e657 0093-3109 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19900930 ANDA ANDA061926 Teva Pharmaceuticals USA Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0093-3122_fe0af637-f290-49da-b761-345acb8124bd 0093-3122 HUMAN PRESCRIPTION DRUG Jinteli norethindrone acetate and ethinyl estradiol TABLET ORAL 20110217 ANDA ANDA076221 Teva Pharmaceuticals USA Inc ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 5; 1 ug/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0093-3123_f5cf34cb-e32d-418f-9eb9-593c73e653d9 0093-3123 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19900930 ANDA ANDA062286 Teva Pharmaceuticals USA Inc DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0093-3125_f5cf34cb-e32d-418f-9eb9-593c73e653d9 0093-3125 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19900930 ANDA ANDA062286 Teva Pharmaceuticals USA Inc DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0093-3127_216f38f8-ee5a-470d-8ab4-ca6441006409 0093-3127 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 19900930 ANDA ANDA070101 Teva Pharmaceuticals USA Inc DISOPYRAMIDE PHOSPHATE 100 mg/1 Antiarrhythmic [EPC] 0093-3129_216f38f8-ee5a-470d-8ab4-ca6441006409 0093-3129 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 19900930 ANDA ANDA070102 Teva Pharmaceuticals USA Inc DISOPYRAMIDE PHOSPHATE 150 mg/1 Antiarrhythmic [EPC] 0093-3134_a77b50c7-8eb0-4879-bf18-5fcbd09fdc8c 0093-3134 HUMAN PRESCRIPTION DRUG CAMRESE levonorgestrel / ethinyl estradiol and ethinyl estradiol KIT 20100728 NDA AUTHORIZED GENERIC NDA021840 TEVA Pharmaceuticals USA Inc 0093-3145_4d9aa03f-c465-4dd2-b361-70f46ca77770 0093-3145 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 19900930 ANDA ANDA062702 Teva Pharmaceuticals USA Inc CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0093-3147_4d9aa03f-c465-4dd2-b361-70f46ca77770 0093-3147 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 19900930 ANDA ANDA062702 Teva Pharmaceuticals USA Inc CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0093-3160_3bc043e3-b46e-443e-97ef-2a34a95a642b 0093-3160 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20070509 ANDA ANDA065368 Teva Pharmaceuticals USA Inc CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0093-3165_c62b6326-2aed-4bb0-a22a-25f3d4e144b7 0093-3165 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19920501 ANDA ANDA063011 Teva Pharmaceuticals USA Inc MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0093-3167_c62b6326-2aed-4bb0-a22a-25f3d4e144b7 0093-3167 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19920501 ANDA ANDA063009 Teva Pharmaceuticals USA Inc MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0093-3171_20ae7fd0-cd99-45ad-971b-120084e1f2fa 0093-3171 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 19900930 20151130 ANDA ANDA063029 Teva Pharmaceuticals USA Inc CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0093-3193_d026018a-1f31-457a-994d-883653762087 0093-3193 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101 ANDA ANDA073516 Teva Pharmaceuticals USA Inc KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-3195_d026018a-1f31-457a-994d-883653762087 0093-3195 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101 ANDA ANDA073517 Teva Pharmaceuticals USA Inc KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-3196_061ef414-4bc6-461c-bc95-f71de2055b2e 0093-3196 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20070131 ANDA ANDA065282 Teva Pharmaceuticals USA Inc CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0093-4029_d3ba6c88-9df4-4124-ae10-e44d9155af3f 0093-4029 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20071214 ANDA ANDA070719 Teva Pharmaceuticals USA Inc INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-4030_d3ba6c88-9df4-4124-ae10-e44d9155af3f 0093-4030 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20071214 ANDA ANDA070756 Teva Pharmaceuticals USA Inc INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-4059_5950969d-6cbb-4327-a649-af4b77b39692 0093-4059 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil TABLET ORAL 20070131 ANDA ANDA062774 Teva Pharmaceuticals USA Inc CEFADROXIL 1000 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0093-4067_136cd1d5-5dcf-4457-8ce1-3b61029f132d 0093-4067 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071994 Teva Pharmaceuticals USA Inc PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0093-4068_136cd1d5-5dcf-4457-8ce1-3b61029f132d 0093-4068 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071995 Teva Pharmaceuticals USA Inc PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0093-4069_136cd1d5-5dcf-4457-8ce1-3b61029f132d 0093-4069 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070118 ANDA ANDA071745 Teva Pharmaceuticals USA Inc PRAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0093-4085_1b1823e2-05bb-49cd-9b73-d7305ab119ac 0093-4085 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION RESPIRATORY (INHALATION) 20131119 ANDA ANDA091589 Teva Pharmaceuticals USA Inc TOBRAMYCIN 300 mg/5mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0093-4125_a993a059-e57f-471c-84da-acb642075a40 0093-4125 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 19900930 ANDA ANDA060456 Teva Pharmaceuticals USA Inc PENICILLIN V POTASSIUM 125 mg/5mL 0093-4127_a993a059-e57f-471c-84da-acb642075a40 0093-4127 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 19900930 ANDA ANDA060456 Teva Pharmaceuticals USA Inc PENICILLIN V POTASSIUM 250 mg/5mL 0093-4136_408ccfec-13f6-422b-aaa4-bf0a3de5fe7e 0093-4136 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070508 ANDA ANDA065332 Teva Pharmaceuticals USA Inc CEFDINIR MONOHYDRATE 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0093-4137_408ccfec-13f6-422b-aaa4-bf0a3de5fe7e 0093-4137 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070508 ANDA ANDA065332 Teva Pharmaceuticals USA Inc CEFDINIR MONOHYDRATE 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0093-4145_83aa60ae-4aa5-4be5-8918-09e36109ec66 0093-4145 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol SOLUTION RESPIRATORY (INHALATION) 20130429 ANDA ANDA090297 Teva Pharmaceuticals USA Inc LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0093-4146_83aa60ae-4aa5-4be5-8918-09e36109ec66 0093-4146 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol SOLUTION RESPIRATORY (INHALATION) 20130429 ANDA ANDA090297 Teva Pharmaceuticals USA Inc LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0093-4147_64338698-5ddc-42ec-99b7-2d8142effe21 0093-4147 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol SOLUTION, CONCENTRATE RESPIRATORY (INHALATION) 20141208 ANDA ANDA200875 Teva Pharmaceuticals USA Inc LEVALBUTEROL HYDROCHLORIDE 1.25 mg/.5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0093-4148_83aa60ae-4aa5-4be5-8918-09e36109ec66 0093-4148 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol SOLUTION RESPIRATORY (INHALATION) 20130429 ANDA ANDA090297 Teva Pharmaceuticals USA Inc LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0093-4150_7f926075-b631-427e-93de-30f0e893e657 0093-4150 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 Teva Pharmaceuticals USA Inc AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0093-4155_7f926075-b631-427e-93de-30f0e893e657 0093-4155 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 Teva Pharmaceuticals USA Inc AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0093-4160_c697d936-8450-4701-b16e-9328e67572d3 0093-4160 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20030402 ANDA ANDA065119 Teva Pharmaceuticals USA Inc AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0093-4161_c697d936-8450-4701-b16e-9328e67572d3 0093-4161 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20030226 ANDA ANDA065119 Teva Pharmaceuticals USA Inc AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0093-4175_4d9aa03f-c465-4dd2-b361-70f46ca77770 0093-4175 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 Teva Pharmaceuticals USA Inc CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0093-4177_4d9aa03f-c465-4dd2-b361-70f46ca77770 0093-4177 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 Teva Pharmaceuticals USA Inc CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0093-4180_034ac4bd-7916-4c95-ae3d-8f7e9e064d38 0093-4180 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20100202 ANDA ANDA065278 TEVA Pharmaceuticals USA Inc CEFADROXIL 250 mg/5mL 0093-4181_034ac4bd-7916-4c95-ae3d-8f7e9e064d38 0093-4181 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20100202 ANDA ANDA065278 TEVA Pharmaceuticals USA Inc CEFADROXIL 500 mg/5mL 0093-4232_cf5bdbcd-f4c8-46dc-98eb-d6a6f22788fe 0093-4232 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Teva Pharmaceuticals USA Inc BUMETANIDE .5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0093-4233_cf5bdbcd-f4c8-46dc-98eb-d6a6f22788fe 0093-4233 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Teva Pharmaceuticals USA Inc BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0093-4234_cf5bdbcd-f4c8-46dc-98eb-d6a6f22788fe 0093-4234 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Teva Pharmaceuticals USA Inc BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0093-4235_83539758-6c72-4707-9e63-5a2499d3f99a 0093-4235 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081103 ANDA ANDA074229 Teva Pharmaceuticals USA Inc NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0093-4236_83539758-6c72-4707-9e63-5a2499d3f99a 0093-4236 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081103 ANDA ANDA074229 Teva Pharmaceuticals USA Inc NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0093-4237_83539758-6c72-4707-9e63-5a2499d3f99a 0093-4237 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081103 ANDA ANDA074255 Teva Pharmaceuticals USA Inc NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0093-4346_47df74f2-cc3e-4d9d-9444-4dc3ff7bd4fa 0093-4346 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20120829 ANDA ANDA075245 Teva Pharmaceuticals USA Inc FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-4359_1c56e83b-8de2-4b41-9e3f-30896e3a192b 0093-4359 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20070510 ANDA ANDA074949 Teva Pharmaceuticals USA Inc CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] 0093-4404_1c56e83b-8de2-4b41-9e3f-30896e3a192b 0093-4404 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20070319 ANDA ANDA076809 Teva Pharmaceuticals USA Inc CLOZAPINE 50 mg/1 Atypical Antipsychotic [EPC] 0093-4405_1c56e83b-8de2-4b41-9e3f-30896e3a192b 0093-4405 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20070515 ANDA ANDA076809 Teva Pharmaceuticals USA Inc CLOZAPINE 200 mg/1 Atypical Antipsychotic [EPC] 0093-4443_10f65a22-6240-4d27-bd28-f105424bc17c 0093-4443 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20080711 ANDA ANDA076017 Teva Pharmaceuticals USA Inc GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0093-4444_10f65a22-6240-4d27-bd28-f105424bc17c 0093-4444 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20080801 ANDA ANDA076017 Teva Pharmaceuticals USA Inc GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0093-4740_b21162cd-5f3d-4156-9070-3c053921a20c 0093-4740 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20070222 ANDA ANDA077048 Teva Pharmaceuticals USA Inc CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-4741_b21162cd-5f3d-4156-9070-3c053921a20c 0093-4741 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20070222 ANDA ANDA077048 Teva Pharmaceuticals USA Inc CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-4742_b21162cd-5f3d-4156-9070-3c053921a20c 0093-4742 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20071108 ANDA ANDA077048 Teva Pharmaceuticals USA Inc CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-4820_3f5dbf3a-8334-4681-8b6f-76655517e1ad 0093-4820 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070201 ANDA ANDA077396 Teva Pharmaceuticals USA Inc LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0093-4821_3f5dbf3a-8334-4681-8b6f-76655517e1ad 0093-4821 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070201 ANDA ANDA077396 Teva Pharmaceuticals USA Inc LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0093-4822_3f5dbf3a-8334-4681-8b6f-76655517e1ad 0093-4822 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070201 ANDA ANDA077396 Teva Pharmaceuticals USA Inc LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0093-5035_b064d556-cff0-486d-89cf-c5ca37b56adf 0093-5035 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20110415 ANDA ANDA088482 Teva Pharmaceuticals USA Inc DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] 0093-5036_b064d556-cff0-486d-89cf-c5ca37b56adf 0093-5036 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20110719 ANDA ANDA088483 Teva Pharmaceuticals USA Inc DISULFIRAM 500 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] 0093-5049_a7ece92f-babe-421f-830c-4ea9561cc62c 0093-5049 HUMAN PRESCRIPTION DRUG Pioglitazone and Metformin Hydrocholride pioglitazone and metformin hydrochloride TABLET, FILM COATED ORAL 20120817 NDA AUTHORIZED GENERIC NDA021842 Teva Pharmaceuticals USA METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0093-5050_a7ece92f-babe-421f-830c-4ea9561cc62c 0093-5050 HUMAN PRESCRIPTION DRUG Pioglitazone and Metformin Hydrocholride pioglitazone and metformin hydrochloride TABLET, FILM COATED ORAL 20120817 NDA AUTHORIZED GENERIC NDA021842 Teva Pharmaceuticals USA METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0093-5060_9496a84b-2717-4b8f-95cd-2952407fa20e 0093-5060 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20130219 ANDA ANDA088617 Teva Pharmaceuticals USA Inc HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0093-5061_9496a84b-2717-4b8f-95cd-2952407fa20e 0093-5061 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20121009 ANDA ANDA088618 Teva Pharmaceuticals USA Inc HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0093-5062_9496a84b-2717-4b8f-95cd-2952407fa20e 0093-5062 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20121022 ANDA ANDA088619 Teva Pharmaceuticals USA Inc HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0093-5105_e498875f-55a0-9b01-0fc3-b94fc6c29191 0093-5105 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076133 Teva Pharmaceuticals USA OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 0093-5112_81291f8a-c451-4aef-9ba9-8ca1338cb781 0093-5112 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 TEVA Pharmaceuticals USA Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0093-5116_50d43265-faf4-42c7-b69f-261f3eb16341 0093-5116 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, EXTENDED RELEASE ORAL 19980731 ANDA ANDA075028 Teva Pharmaceuticals USA Inc PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 0093-5117_81291f8a-c451-4aef-9ba9-8ca1338cb781 0093-5117 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 TEVA Pharmaceuticals USA Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0093-5118_81291f8a-c451-4aef-9ba9-8ca1338cb781 0093-5118 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 TEVA Pharmaceuticals USA Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0093-5119_81291f8a-c451-4aef-9ba9-8ca1338cb781 0093-5119 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 TEVA Pharmaceuticals USA Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0093-5124_055401c6-22a0-4204-b0b6-80c00f7f4205 0093-5124 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 Teva Pharmaceuticals USA Inc BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0093-5125_055401c6-22a0-4204-b0b6-80c00f7f4205 0093-5125 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 Teva Pharmaceuticals USA Inc BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0093-5126_055401c6-22a0-4204-b0b6-80c00f7f4205 0093-5126 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 Teva Pharmaceuticals USA Inc BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0093-5127_055401c6-22a0-4204-b0b6-80c00f7f4205 0093-5127 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 Teva Pharmaceuticals USA Inc BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0093-5140_f08db725-fc65-4eb4-87f3-fd04d41fe5d1 0093-5140 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Teva Pharmaceuticals USA Inc ALENDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0093-5141_f08db725-fc65-4eb4-87f3-fd04d41fe5d1 0093-5141 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Teva Pharmaceuticals USA Inc ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0093-5142_f08db725-fc65-4eb4-87f3-fd04d41fe5d1 0093-5142 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Teva Pharmaceuticals USA Inc ALENDRONATE SODIUM 40 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0093-5150_2fca5cf6-f0a0-42a4-9485-de56f6ac8dbe 0093-5150 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET, FILM COATED ORAL 20030508 ANDA ANDA076204 Teva Pharmaceuticals USA Inc MOEXIPRIL HYDROCHLORIDE 15 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0093-5161_c5a243a6-da46-4bdb-9e3b-b0c88d5f403e 0093-5161 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 20030415 20160131 ANDA ANDA076023 Teva Pharmaceuticals USA Inc HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 0093-5171_f08db725-fc65-4eb4-87f3-fd04d41fe5d1 0093-5171 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Teva Pharmaceuticals USA Inc ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0093-5172_f08db725-fc65-4eb4-87f3-fd04d41fe5d1 0093-5172 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Teva Pharmaceuticals USA Inc ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0093-5173_2a4f333b-0dfe-4762-8fee-94e7f4242bb3 0093-5173 HUMAN PRESCRIPTION DRUG Nifedical XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20001211 ANDA ANDA075289 Teva Pharmaceuticals USA Inc NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0093-5200_77aba923-3a73-421f-bbad-ae6aee683773 0093-5200 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20040326 ANDA ANDA075022 Teva Pharmaceuticals USA Inc BUSPIRONE HYDROCHLORIDE 30 mg/1 0093-5206_5cb537c1-c3cd-4612-9416-1329f9bd1e26 0093-5206 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20070511 ANDA ANDA076745 TEVA Pharmaceuticals USA Inc OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0093-5207_5cb537c1-c3cd-4612-9416-1329f9bd1e26 0093-5207 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20070511 ANDA ANDA076745 TEVA Pharmaceuticals USA Inc OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0093-5208_5cb537c1-c3cd-4612-9416-1329f9bd1e26 0093-5208 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20061110 ANDA ANDA076745 TEVA Pharmaceuticals USA Inc OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0093-5213_7176f8ee-94b8-4bc0-bb0e-e659a9ff2735 0093-5213 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20070307 ANDA ANDA076980 Teva Pharmaceuticals USA Inc HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5; 7.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0093-5214_7176f8ee-94b8-4bc0-bb0e-e659a9ff2735 0093-5214 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20070307 ANDA ANDA076980 Teva Pharmaceuticals USA Inc HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5; 15 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0093-5215_7176f8ee-94b8-4bc0-bb0e-e659a9ff2735 0093-5215 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20070307 ANDA ANDA076980 Teva Pharmaceuticals USA Inc HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 25; 15 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0093-5245_abae9d2f-462e-4296-9c67-2be135255078 0093-5245 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120217 ANDA ANDA077243 Teva Pharmaceuticals USA Inc OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 0093-5246_abae9d2f-462e-4296-9c67-2be135255078 0093-5246 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120217 ANDA ANDA077243 Teva Pharmaceuticals USA Inc OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 0093-5247_abae9d2f-462e-4296-9c67-2be135255078 0093-5247 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120124 ANDA ANDA077243 Teva Pharmaceuticals USA Inc OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 0093-5248_abae9d2f-462e-4296-9c67-2be135255078 0093-5248 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120124 ANDA ANDA077243 Teva Pharmaceuticals USA Inc OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 0093-5256_20ae7fd0-cd99-45ad-971b-120084e1f2fa 0093-5256 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20050809 20151031 ANDA ANDA063029 Teva Pharmaceuticals USA Inc CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0093-5268_9bac465d-1dea-483d-a9fe-34f87675ee76 0093-5268 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20080606 ANDA ANDA077239 Teva Pharmaceuticals USA Inc ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 0093-5269_9bac465d-1dea-483d-a9fe-34f87675ee76 0093-5269 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20080606 ANDA ANDA077239 Teva Pharmaceuticals USA Inc ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 0093-5270_4bc2d76a-4672-46b4-8a32-6cc5f8886d01 0093-5270 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol Fumarate TABLET, FILM COATED ORAL 20040601 ANDA ANDA075644 Teva Pharmaceuticals USA Inc BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0093-5271_4bc2d76a-4672-46b4-8a32-6cc5f8886d01 0093-5271 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol Fumarate TABLET, FILM COATED ORAL 20040601 ANDA ANDA075644 Teva Pharmaceuticals USA Inc BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0093-5275_47515ad1-d92c-47d9-9585-5bf38b36ada6 0093-5275 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20070608 ANDA ANDA077107 Teva Pharmaceuticals USA Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0093-5276_47515ad1-d92c-47d9-9585-5bf38b36ada6 0093-5276 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20070608 ANDA ANDA077107 Teva Pharmaceuticals USA Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0093-5277_47515ad1-d92c-47d9-9585-5bf38b36ada6 0093-5277 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20070608 ANDA ANDA077107 Teva Pharmaceuticals USA Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0093-5289_5b991aed-b438-4a94-a117-0cb58ffe27e0 0093-5289 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20120601 ANDA ANDA091658 Teva Pharmaceuticals USA Inc VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0093-5290_5b991aed-b438-4a94-a117-0cb58ffe27e0 0093-5290 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20120601 ANDA ANDA091658 Teva Pharmaceuticals USA Inc VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0093-5292_ae88c94e-2e64-41c6-9e44-463a64956796 0093-5292 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (CD) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120927 ANDA ANDA078873 Teva Pharmaceuticals USA Inc METHYLPHENIDATE HYDROCHLORIDE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0093-5293_ae88c94e-2e64-41c6-9e44-463a64956796 0093-5293 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (CD) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120927 ANDA ANDA078873 Teva Pharmaceuticals USA Inc METHYLPHENIDATE HYDROCHLORIDE 60 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0093-5295_ae88c94e-2e64-41c6-9e44-463a64956796 0093-5295 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (CD) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120927 ANDA ANDA077707 Teva Pharmaceuticals USA Inc METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0093-5296_ae88c94e-2e64-41c6-9e44-463a64956796 0093-5296 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (CD) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120927 ANDA ANDA077707 Teva Pharmaceuticals USA Inc METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0093-5297_ae88c94e-2e64-41c6-9e44-463a64956796 0093-5297 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (CD) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120927 ANDA ANDA077707 Teva Pharmaceuticals USA Inc METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0093-5298_ae88c94e-2e64-41c6-9e44-463a64956796 0093-5298 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (CD) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120927 ANDA ANDA078873 Teva Pharmaceuticals USA Inc METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0093-5346_1b3f2abf-564b-4abe-814d-f0779950bcb5 0093-5346 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120716 ANDA ANDA079031 Teva Pharmaceuticals USA Inc METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0093-5347_1b3f2abf-564b-4abe-814d-f0779950bcb5 0093-5347 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120716 ANDA ANDA079031 Teva Pharmaceuticals USA Inc METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0093-5348_1b3f2abf-564b-4abe-814d-f0779950bcb5 0093-5348 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120716 ANDA ANDA079031 Teva Pharmaceuticals USA Inc METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0093-5353_f6548d54-f5e5-4df2-95a0-6d60fa663904 0093-5353 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20120301 ANDA ANDA202121 Teva Pharmaceuticals USA Inc PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 0093-5354_f6548d54-f5e5-4df2-95a0-6d60fa663904 0093-5354 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20120301 ANDA ANDA202121 Teva Pharmaceuticals USA Inc PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 0093-5378_4ec56c3d-298f-43da-9af1-201876085576 0093-5378 HUMAN PRESCRIPTION DRUG Buprenorphine Hydrochloride Buprenorphine Hydrochloride TABLET SUBLINGUAL 20100525 ANDA ANDA090360 Teva Pharmaceuticals USA Inc BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 0093-5379_4ec56c3d-298f-43da-9af1-201876085576 0093-5379 HUMAN PRESCRIPTION DRUG Buprenorphine Hydrochloride Buprenorphine Hydrochloride TABLET SUBLINGUAL 20100525 ANDA ANDA090360 Teva Pharmaceuticals USA Inc BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 0093-5385_e07a7d84-748f-4ca1-bfb8-5fc686692bb6 0093-5385 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20111227 ANDA ANDA079081 Teva Pharmaceuticals USA Inc LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0093-5401_8146908c-2e09-41e8-891c-fe21452b2ebe 0093-5401 HUMAN PRESCRIPTION DRUG Omega-3-Acid Ethyl Esters Omega-3-Acid Ethyl Esters CAPSULE, LIQUID FILLED ORAL 20140407 ANDA ANDA091028 Teva Pharmaceuticals USA Inc OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] 0093-5414_54a6695b-4502-4454-b56e-653ecd0f3233 0093-5414 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20080922 ANDA ANDA077523 Teva Pharmaceuticals USA Inc FLUCONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0093-5415_54a6695b-4502-4454-b56e-653ecd0f3233 0093-5415 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20080922 ANDA ANDA077523 Teva Pharmaceuticals USA Inc FLUCONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0093-5420_14b8ea8a-e1e7-459b-a196-d67d8f5dd55e 0093-5420 HUMAN PRESCRIPTION DRUG Cabergoline Cabergoline TABLET ORAL 20070307 ANDA ANDA077750 Teva Pharmaceuticals USA Inc CABERGOLINE .5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 0093-5423_f424c283-aae7-4777-a8dc-9c87487f8db1 0093-5423 HUMAN PRESCRIPTION DRUG Gianvi Drospirenone and ethinyl estradiol KIT 20110330 NDA AUTHORIZED GENERIC NDA021676 Teva Pharmaceuticals USA Inc 0093-5454_c8dea98b-89ae-411a-914a-b1acc48129af 0093-5454 HUMAN PRESCRIPTION DRUG Mimvey Lo Estradiol and Norethindrone Acetate TABLET ORAL 20140602 ANDA ANDA200747 Teva Pharmaceuticals USA Inc ESTRADIOL; NORETHINDRONE ACETATE .5; .1 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0093-5455_c8dea98b-89ae-411a-914a-b1acc48129af 0093-5455 HUMAN PRESCRIPTION DRUG Mimvey Estradiol and Norethindrone Acetate TABLET, FILM COATED ORAL 20100602 ANDA ANDA079193 Teva Pharmaceuticals USA Inc ESTRADIOL; NORETHINDRONE ACETATE 1; .5 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0093-5502_bfacd9e7-0033-44b7-84cb-c92536b7f817 0093-5502 HUMAN PRESCRIPTION DRUG BUDEPRION SR BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20040323 20150131 ANDA ANDA075913 TEVA Pharmaceuticals USA Inc BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0093-5503_05acd4a4-ae3a-4086-b29f-981dd9cfc0c9 0093-5503 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20130410 ANDA ANDA202074 Teva Pharmaceuticals USA Inc FLUOXETINE HYDROCHLORIDE; OLANZAPINE 25; 3 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-5504_05acd4a4-ae3a-4086-b29f-981dd9cfc0c9 0093-5504 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20120619 ANDA ANDA077528 Teva Pharmaceuticals USA Inc FLUOXETINE HYDROCHLORIDE; OLANZAPINE 25; 6 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-5505_05acd4a4-ae3a-4086-b29f-981dd9cfc0c9 0093-5505 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20120619 ANDA ANDA077528 Teva Pharmaceuticals USA Inc FLUOXETINE HYDROCHLORIDE; OLANZAPINE 50; 6 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-5506_05acd4a4-ae3a-4086-b29f-981dd9cfc0c9 0093-5506 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20120619 ANDA ANDA077528 Teva Pharmaceuticals USA Inc FLUOXETINE HYDROCHLORIDE; OLANZAPINE 25; 12 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-5507_05acd4a4-ae3a-4086-b29f-981dd9cfc0c9 0093-5507 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20120619 ANDA ANDA077528 Teva Pharmaceuticals USA Inc FLUOXETINE HYDROCHLORIDE; OLANZAPINE 50; 12 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-5510_6be3d9b2-043b-424e-ab6d-e547fb6a593c 0093-5510 HUMAN PRESCRIPTION DRUG Mercaptopurine Mercaptopurine TABLET ORAL 20050427 NDA NDA009053 Teva Pharmaceuticals USA Inc MERCAPTOPURINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0093-5512_6a81a7e7-967b-427b-b4f8-3623b5873e92 0093-5512 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20130715 ANDA ANDA078592 Teva Pharmaceuticals USA Inc CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0093-5513_6a81a7e7-967b-427b-b4f8-3623b5873e92 0093-5513 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20130211 ANDA ANDA078592 Teva Pharmaceuticals USA Inc CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0093-5514_6a81a7e7-967b-427b-b4f8-3623b5873e92 0093-5514 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20130211 ANDA ANDA078592 Teva Pharmaceuticals USA Inc CARBAMAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0093-5517_925923b0-128a-49b6-8d31-a3ed26d979c4 0093-5517 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20130531 ANDA ANDA078380 Teva Pharmaceuticals USA Inc SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0093-5537_2837074b-d93b-4a24-ab7c-195e5639a216 0093-5537 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140414 ANDA ANDA091169 Teva Pharmaceuticals USA Inc ESZOPICLONE 1 mg/1 CIV 0093-5538_2837074b-d93b-4a24-ab7c-195e5639a216 0093-5538 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140414 ANDA ANDA091169 Teva Pharmaceuticals USA Inc ESZOPICLONE 2 mg/1 CIV 0093-5539_2837074b-d93b-4a24-ab7c-195e5639a216 0093-5539 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140414 ANDA ANDA091169 Teva Pharmaceuticals USA Inc ESZOPICLONE 3 mg/1 CIV 0093-5550_80027f6e-afa9-414e-b6bd-5ba6550f6e9b 0093-5550 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141110 ANDA ANDA078908 Teva Pharmaceuticals USA Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0093-5552_80027f6e-afa9-414e-b6bd-5ba6550f6e9b 0093-5552 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140521 ANDA ANDA078908 Teva Pharmaceuticals USA Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0093-5554_b507e95a-3885-40ed-abf5-619e47d0d5d9 0093-5554 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140519 ANDA ANDA202731 Teva Pharmaceuticals USA Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0093-5562_b507e95a-3885-40ed-abf5-619e47d0d5d9 0093-5562 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20131121 ANDA ANDA202731 Teva Pharmaceuticals USA Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0093-5703_16d1b61c-c646-43b5-bce4-60142d540d1c 0093-5703 HUMAN PRESCRIPTION DRUG BUPROBAN BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20040527 ANDA ANDA075914 TEVA Pharmaceuticals USA Inc BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0093-5710_f6e1b46f-48d8-412e-a33d-2025ad38efd9 0093-5710 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20070614 ANDA ANDA076345 Teva Pharmaceuticals USA Inc GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0093-5711_f6e1b46f-48d8-412e-a33d-2025ad38efd9 0093-5711 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20070507 ANDA ANDA076345 Teva Pharmaceuticals USA Inc GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0093-5712_f6e1b46f-48d8-412e-a33d-2025ad38efd9 0093-5712 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20070614 ANDA ANDA076345 Teva Pharmaceuticals USA Inc GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0093-5720_036ddabb-7886-49a4-8ab4-094f74f0609c 0093-5720 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone Buprenorphine and Naloxone TABLET SUBLINGUAL 20141201 ANDA ANDA091149 Teva Pharmaceuticals USA Inc BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 0093-5721_036ddabb-7886-49a4-8ab4-094f74f0609c 0093-5721 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone Buprenorphine and Naloxone TABLET SUBLINGUAL 20141201 ANDA ANDA091149 Teva Pharmaceuticals USA Inc BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 0093-5767_bca1e992-10ca-4e2e-b4d7-e267d1ae5453 0093-5767 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Teva Pharmaceuticals USA Inc OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 0093-5768_bca1e992-10ca-4e2e-b4d7-e267d1ae5453 0093-5768 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Teva Pharmaceuticals USA Inc OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 0093-5769_bca1e992-10ca-4e2e-b4d7-e267d1ae5453 0093-5769 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Teva Pharmaceuticals USA Inc OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 0093-5770_bca1e992-10ca-4e2e-b4d7-e267d1ae5453 0093-5770 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Teva Pharmaceuticals USA Inc OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 0093-5771_bca1e992-10ca-4e2e-b4d7-e267d1ae5453 0093-5771 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Teva Pharmaceuticals USA Inc OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 0093-5786_64f5bae6-0d50-481e-9641-30160f94146d 0093-5786 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET, FILM COATED ORAL 20140904 ANDA ANDA202122 Teva Pharmaceuticals USA Inc ENTECAVIR .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0093-5787_64f5bae6-0d50-481e-9641-30160f94146d 0093-5787 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET, FILM COATED ORAL 20140904 ANDA ANDA202122 Teva Pharmaceuticals USA Inc ENTECAVIR 1 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0093-5850_ba234e00-2fb8-4a3d-b486-49226bce92d1 0093-5850 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Teva Pharmaceuticals USA Inc ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-5851_ba234e00-2fb8-4a3d-b486-49226bce92d1 0093-5851 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Teva Pharmaceuticals USA Inc ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-5852_ba234e00-2fb8-4a3d-b486-49226bce92d1 0093-5852 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Teva Pharmaceuticals USA Inc ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-5861_8468c167-08d7-4e16-a2f1-e83c97f34c79 0093-5861 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20130411 ANDA ANDA091443 Teva Pharmaceuticals USA Inc OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0093-5862_8468c167-08d7-4e16-a2f1-e83c97f34c79 0093-5862 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20130411 ANDA ANDA091443 Teva Pharmaceuticals USA Inc OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0093-6108_c043d576-b78d-4757-8d56-a821c5010c97 0093-6108 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine SOLUTION ORAL 20010802 ANDA ANDA075506 Teva Pharmaceuticals USA Inc FLUOXETINE HYDROCHLORIDE 20 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-6118_62254419-e57f-45eb-8540-9de9b989412a 0093-6118 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 19981211 ANDA ANDA089081 Teva Pharmaceuticals USA Inc PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0093-6126_8e629f40-8f07-411d-badc-41bd2cd7d257 0093-6126 HUMAN PRESCRIPTION DRUG Imiquimod Imiquimod CREAM TOPICAL 20131205 ANDA ANDA200481 Teva Pharmaceuticals USA Inc IMIQUIMOD 50 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 0093-6137_d9e39f4e-ac62-4521-a1db-650295e6d260 0093-6137 HUMAN PRESCRIPTION DRUG Diazepam Diazepam GEL RECTAL 20101001 NDA AUTHORIZED GENERIC NDA020648 Teva Pharmaceuticals USA Inc DIAZEPAM 2.5 mg/.5mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0093-6138_d9e39f4e-ac62-4521-a1db-650295e6d260 0093-6138 HUMAN PRESCRIPTION DRUG Diazepam Diazepam GEL RECTAL 20100903 NDA AUTHORIZED GENERIC NDA020648 Teva Pharmaceuticals USA Inc DIAZEPAM 10 mg/2mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0093-6139_d9e39f4e-ac62-4521-a1db-650295e6d260 0093-6139 HUMAN PRESCRIPTION DRUG Diazepam Diazepam GEL RECTAL 20100903 NDA AUTHORIZED GENERIC NDA020648 Teva Pharmaceuticals USA Inc DIAZEPAM 20 mg/4mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0093-6148_1cad1cf5-e7e2-4fd2-b4d8-bf108e3fad43 0093-6148 HUMAN PRESCRIPTION DRUG CamreseLo levonorgestrel/ethinyl estradiol and ethinyl estradiol KIT 20101207 NDA AUTHORIZED GENERIC NDA022262 Teva Pharmaceuticals USA Inc 0093-6300_035b60b5-b0f0-4791-87f3-cb310611f034 0093-6300 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SYRUP ORAL 20080530 20151130 ANDA ANDA077279 Teva Pharmaceuticals USA Inc CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0093-6301_12ec87d0-8a07-4d80-ba71-70420c4993d2 0093-6301 HUMAN PRESCRIPTION DRUG Adapalene Adapalene GEL TOPICAL 20100602 ANDA ANDA090962 Teva Pharmaceuticals USA Inc ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0093-6723_bca3e1ad-3173-4d0f-bb4b-c327bb3b52c9 0093-6723 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20080102 ANDA ANDA076724 Teva Pharmaceuticals USA Inc ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 2.5; .5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0093-6815_493f0d81-2ae4-4451-bfae-40153a269c22 0093-6815 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20081119 ANDA ANDA077519 Teva Pharmaceuticals USA Inc BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0093-6816_493f0d81-2ae4-4451-bfae-40153a269c22 0093-6816 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20081119 ANDA ANDA077519 Teva Pharmaceuticals USA Inc BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0093-6900_2c809d02-3765-4150-8f11-87ab7a3c4c2e 0093-6900 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20081222 ANDA ANDA077449 Teva Pharmaceuticals USA Inc FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0093-6901_2c809d02-3765-4150-8f11-87ab7a3c4c2e 0093-6901 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20081222 ANDA ANDA077449 Teva Pharmaceuticals USA Inc FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0093-6902_2c809d02-3765-4150-8f11-87ab7a3c4c2e 0093-6902 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20081020 ANDA ANDA077449 Teva Pharmaceuticals USA Inc FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0093-6903_2c809d02-3765-4150-8f11-87ab7a3c4c2e 0093-6903 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20081020 ANDA ANDA077449 Teva Pharmaceuticals USA Inc FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0093-7037_1d8398fe-6389-4e11-9e55-71508cb33475 0093-7037 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan, and Hydrochlorothiazide Amlodipine, Valsartan, and Hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 ANDA ANDA200435 Teva Pharmaceuticals USA Inc AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5; 25; 160 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0093-7038_1d8398fe-6389-4e11-9e55-71508cb33475 0093-7038 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan, and Hydrochlorothiazide Amlodipine, Valsartan, and Hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 ANDA ANDA200435 Teva Pharmaceuticals USA Inc AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10; 25; 160 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0093-7102_b2dbae30-4320-4400-9d15-dca3c1a72728 0093-7102 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin SUSPENSION ORAL 20080212 ANDA ANDA065354 Teva Pharmaceuticals USA Inc GRISEOFULVIN 125 mg/5mL Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 0093-7113_75d6633e-1f1d-46cd-baec-d8a91c223df9 0093-7113 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Teva Pharmaceuticals USA Inc NEFAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 0093-7114_c8d0f8ca-15a3-4987-bc72-17e03ae4b510 0093-7114 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20051107 ANDA ANDA076618 Teva Pharmaceuticals USA Inc PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-7115_c8d0f8ca-15a3-4987-bc72-17e03ae4b510 0093-7115 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20051003 ANDA ANDA076618 Teva Pharmaceuticals USA Inc PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-7116_c8d0f8ca-15a3-4987-bc72-17e03ae4b510 0093-7116 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20051102 ANDA ANDA076618 Teva Pharmaceuticals USA Inc PAROXETINE HYDROCHLORIDE ANHYDROUS 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-7121_c8d0f8ca-15a3-4987-bc72-17e03ae4b510 0093-7121 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20051102 ANDA ANDA076618 Teva Pharmaceuticals USA Inc PAROXETINE HYDROCHLORIDE ANHYDROUS 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-7146_932933b7-3254-4229-916b-f6542fe92ef9 0093-7146 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065153 Teva Pharmaceuticals USA Inc AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0093-7147_ec78999e-70ea-4946-9846-a23d5f37d193 0093-7147 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065150 Teva Pharmaceuticals USA Inc AZITHROMYCIN MONOHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0093-7148_277bc0b6-4ffa-4ccc-a471-747dc23b8d7b 0093-7148 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin Monohydrate POWDER, FOR SUSPENSION ORAL 20080922 ANDA ANDA065419 Teva Pharmaceuticals USA Inc AZITHROMYCIN MONOHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0093-7149_277bc0b6-4ffa-4ccc-a471-747dc23b8d7b 0093-7149 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin Monohydrate POWDER, FOR SUSPENSION ORAL 20080922 ANDA ANDA065419 Teva Pharmaceuticals USA Inc AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0093-7152_d2fc2c17-c8a1-4889-b363-8f69e78bd7a3 0093-7152 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 Teva Pharmaceuticals USA Inc SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0093-7153_d2fc2c17-c8a1-4889-b363-8f69e78bd7a3 0093-7153 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 Teva Pharmaceuticals USA Inc SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0093-7154_d2fc2c17-c8a1-4889-b363-8f69e78bd7a3 0093-7154 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 Teva Pharmaceuticals USA Inc SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0093-7155_d2fc2c17-c8a1-4889-b363-8f69e78bd7a3 0093-7155 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 Teva Pharmaceuticals USA Inc SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0093-7156_d2fc2c17-c8a1-4889-b363-8f69e78bd7a3 0093-7156 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA076052 Teva Pharmaceuticals USA Inc SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0093-7157_c641e54a-c511-4936-b1bf-0c20dae3eecc 0093-7157 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20050628 ANDA ANDA065155 Teva Pharmaceuticals USA Inc CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0093-7158_c641e54a-c511-4936-b1bf-0c20dae3eecc 0093-7158 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20050628 ANDA ANDA065155 Teva Pharmaceuticals USA Inc CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0093-7165_aa63f75d-5a60-4f3e-b029-41bd68c8f31b 0093-7165 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 Teva Pharmaceuticals USA Inc CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-7166_aa63f75d-5a60-4f3e-b029-41bd68c8f31b 0093-7166 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 Teva Pharmaceuticals USA Inc CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-7167_1005c6bc-abb5-47dd-a334-a3f22b4d5c3c 0093-7167 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070710 ANDA ANDA076846 Teva Pharmaceuticals USA Inc AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0093-7168_1005c6bc-abb5-47dd-a334-a3f22b4d5c3c 0093-7168 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070710 ANDA ANDA076846 Teva Pharmaceuticals USA Inc AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0093-7169_932933b7-3254-4229-916b-f6542fe92ef9 0093-7169 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065193 Teva Pharmaceuticals USA Inc AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0093-7170_aa63f75d-5a60-4f3e-b029-41bd68c8f31b 0093-7170 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 Teva Pharmaceuticals USA Inc CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-7172_45516aef-46cc-46bd-a506-3a33ed033534 0093-7172 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000811 ANDA ANDA075665 Teva Pharmaceuticals USA Inc ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-7178_75d6633e-1f1d-46cd-baec-d8a91c223df9 0093-7178 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Teva Pharmaceuticals USA Inc NEFAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 0093-7180_0c10a51f-d6c8-4ccb-bdb4-cbdb0fdae89f 0093-7180 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin TABLET, FILM COATED ORAL 20040128 20150331 ANDA ANDA076182 Teva Pharmaceuticals USA Inc OFLOXACIN 200 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0093-7181_0c10a51f-d6c8-4ccb-bdb4-cbdb0fdae89f 0093-7181 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin TABLET, FILM COATED ORAL 20040128 20150731 ANDA ANDA076182 Teva Pharmaceuticals USA Inc OFLOXACIN 300 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0093-7182_0c10a51f-d6c8-4ccb-bdb4-cbdb0fdae89f 0093-7182 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin TABLET, FILM COATED ORAL 20040128 20150731 ANDA ANDA076182 Teva Pharmaceuticals USA Inc OFLOXACIN 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0093-7188_9c95ae63-b571-4cc7-982e-db029d03992c 0093-7188 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride TABLET, FILM COATED ORAL 20020130 ANDA ANDA075872 Teva Pharmaceuticals USA Inc FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-7198_4aaaad60-932c-4101-9a66-109e10d0f732 0093-7198 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020130 ANDA ANDA075452 Teva Pharmaceuticals USA Inc FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-7201_d85e5a03-381d-4a3e-9cd0-f97ced630300 0093-7201 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20060425 ANDA ANDA076056 Teva Pharmaceuticals USA Inc PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0093-7202_d85e5a03-381d-4a3e-9cd0-f97ced630300 0093-7202 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20060425 ANDA ANDA076056 Teva Pharmaceuticals USA Inc PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0093-7206_ef729829-f014-4332-b1b3-ea2a46a1545e 0093-7206 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030129 ANDA ANDA076119 Teva Pharmaceuticals USA Inc MIRTAZAPINE 15 mg/1 0093-7207_ef729829-f014-4332-b1b3-ea2a46a1545e 0093-7207 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030129 ANDA ANDA076119 Teva Pharmaceuticals USA Inc MIRTAZAPINE 30 mg/1 0093-7208_ef729829-f014-4332-b1b3-ea2a46a1545e 0093-7208 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076119 Teva Pharmaceuticals USA Inc MIRTAZAPINE 45 mg/1 0093-7212_c3bc4fec-4d87-4602-888a-d7121f561a35 0093-7212 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20050413 ANDA ANDA076864 Teva Pharmaceuticals USA Inc METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0093-7214_0ce4d94c-3472-4839-967b-45e845290a36 0093-7214 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20030417 ANDA ANDA075978 Teva Pharmaceuticals USA Inc METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0093-7219_8251c4c2-9c4a-4a5c-afdc-eba2811bf48f 0093-7219 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20090331 ANDA ANDA076317 Teva Pharmaceuticals USA Inc TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0093-7220_8251c4c2-9c4a-4a5c-afdc-eba2811bf48f 0093-7220 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20090331 ANDA ANDA076317 Teva Pharmaceuticals USA Inc TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0093-7222_a733b7d3-d690-42ab-aa97-eadfee03e976 0093-7222 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20031201 ANDA ANDA076139 Teva Pharmaceuticals USA Inc FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0093-7223_a733b7d3-d690-42ab-aa97-eadfee03e976 0093-7223 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20031201 ANDA ANDA076139 Teva Pharmaceuticals USA Inc FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0093-7224_a733b7d3-d690-42ab-aa97-eadfee03e976 0093-7224 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20031201 ANDA ANDA076139 Teva Pharmaceuticals USA Inc FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0093-7227_4afa835e-046a-46d8-ae04-59157f36675c 0093-7227 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin CAPSULE ORAL 20041004 20151130 ANDA ANDA076277 Teva Pharmaceuticals USA Inc RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 0093-7232_cbb0affc-7ca6-434b-abb4-84dbbf482c5a 0093-7232 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, COATED ORAL 20051205 ANDA ANDA077053 Teva Pharmaceuticals USA Inc RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 0093-7234_8b865b02-2a5e-45e4-af3b-c9ca69284876 0093-7234 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060720 ANDA ANDA077936 Teva Pharmaceuticals USA Inc MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-7236_0f611c9e-16b0-4bf2-b237-80142542fb29 0093-7236 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070703 ANDA ANDA076252 Teva Pharmaceuticals USA Inc ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0093-7244_95b5b736-0de2-4a50-9bd2-af5348f1286c 0093-7244 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060623 ANDA ANDA065154 Teva Pharmaceuticals USA Inc CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0093-7247_c9e57ca5-e493-4c48-98c4-a34b75a365dc 0093-7247 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20080722 ANDA ANDA076388 Teva Pharmaceuticals USA Inc LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0093-7248_c9e57ca5-e493-4c48-98c4-a34b75a365dc 0093-7248 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20080722 ANDA ANDA076388 Teva Pharmaceuticals USA Inc LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0093-7254_a46fa6cf-69fe-4231-a610-9508407f3be1 0093-7254 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA076802 Teva Pharmaceuticals USA Inc GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0093-7255_a46fa6cf-69fe-4231-a610-9508407f3be1 0093-7255 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA076802 Teva Pharmaceuticals USA Inc GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0093-7256_a46fa6cf-69fe-4231-a610-9508407f3be1 0093-7256 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA076802 Teva Pharmaceuticals USA Inc GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0093-7258_8460afa3-ef0e-48b1-baa9-3d6eb130f325 0093-7258 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20100524 ANDA ANDA077655 Teva Pharmaceuticals USA Inc VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0093-7259_8460afa3-ef0e-48b1-baa9-3d6eb130f325 0093-7259 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20100524 ANDA ANDA077655 Teva Pharmaceuticals USA Inc VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0093-7267_c3bc4fec-4d87-4602-888a-d7121f561a35 0093-7267 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20040618 ANDA ANDA076269 Teva Pharmaceuticals USA Inc METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0093-7270_b3c43184-9c68-4d9e-813c-70bc97b5bc8c 0093-7270 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20080929 ANDA ANDA077793 Teva Pharmaceuticals USA Inc PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0093-7285_e6ff7b7e-4271-4a6d-b65f-53200b0169f6 0093-7285 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078101 Teva Pharmaceuticals USA Inc LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0093-7286_e6ff7b7e-4271-4a6d-b65f-53200b0169f6 0093-7286 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078101 Teva Pharmaceuticals USA Inc LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0093-7287_e6ff7b7e-4271-4a6d-b65f-53200b0169f6 0093-7287 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078101 Teva Pharmaceuticals USA Inc LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0093-7290_37114fe5-d4b0-4033-b055-454c31e9b412 0093-7290 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET, FILM COATED ORAL 20140328 ANDA ANDA078193 Teva Pharmaceuticals USA Inc RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 0093-7291_d141d571-9dc3-429d-a450-e6c61f295a6d 0093-7291 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Teva Pharmaceuticals USA Inc LEVOFLOXACIN 250 mg/1 0093-7292_d141d571-9dc3-429d-a450-e6c61f295a6d 0093-7292 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Teva Pharmaceuticals USA Inc LEVOFLOXACIN 500 mg/1 0093-7293_d141d571-9dc3-429d-a450-e6c61f295a6d 0093-7293 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Teva Pharmaceuticals USA Inc LEVOFLOXACIN 750 mg/1 0093-7295_b186b5ce-431f-4219-94f4-302594f3125e 0093-7295 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070906 ANDA ANDA076373 Teva Pharmaceuticals USA Inc CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0093-7296_b186b5ce-431f-4219-94f4-302594f3125e 0093-7296 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070906 ANDA ANDA076373 Teva Pharmaceuticals USA Inc CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0093-7299_8b865b02-2a5e-45e4-af3b-c9ca69284876 0093-7299 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060720 ANDA ANDA077936 Teva Pharmaceuticals USA Inc MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-7300_c62b6326-2aed-4bb0-a22a-25f3d4e144b7 0093-7300 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20040630 ANDA ANDA063009 Teva Pharmaceuticals USA Inc MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0093-7303_f35b7222-09af-405f-8d30-c43d6bfbc187 0093-7303 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20050901 ANDA ANDA076901 Teva Pharmaceuticals USA Inc MIRTAZAPINE 15 mg/1 0093-7304_f35b7222-09af-405f-8d30-c43d6bfbc187 0093-7304 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20050901 ANDA ANDA076901 Teva Pharmaceuticals USA Inc MIRTAZAPINE 30 mg/1 0093-7305_f35b7222-09af-405f-8d30-c43d6bfbc187 0093-7305 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20050901 ANDA ANDA076901 Teva Pharmaceuticals USA Inc MIRTAZAPINE 45 mg/1 0093-7306_aa63f75d-5a60-4f3e-b029-41bd68c8f31b 0093-7306 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 Teva Pharmaceuticals USA Inc CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0093-7314_90c2699c-bee5-48a3-bfda-478d66c5a261 0093-7314 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA076999 Teva Pharmaceuticals USA Inc CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 0093-7316_12d17045-dd4a-44b9-95bc-3f40a94c0ca3 0093-7316 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20060127 ANDA ANDA077122 Teva Pharmaceuticals USA Inc DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 0093-7317_12d17045-dd4a-44b9-95bc-3f40a94c0ca3 0093-7317 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20060127 ANDA ANDA077122 Teva Pharmaceuticals USA Inc DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 0093-7325_3b2cd97a-6549-41ed-8ca8-df758d8cce60 0093-7325 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070207 ANDA ANDA077489 Teva Pharmaceuticals USA Inc TRANDOLAPRIL 1 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0093-7326_3b2cd97a-6549-41ed-8ca8-df758d8cce60 0093-7326 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070207 ANDA ANDA077489 Teva Pharmaceuticals USA Inc TRANDOLAPRIL 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0093-7327_3b2cd97a-6549-41ed-8ca8-df758d8cce60 0093-7327 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070207 ANDA ANDA077489 Teva Pharmaceuticals USA Inc TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0093-7334_930ada08-007e-429d-94d9-55682868a380 0093-7334 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20090506 ANDA ANDA065491 Teva Pharmaceuticals USA Inc MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 0093-7335_d7dd5635-0975-4193-84b1-4302055fa200 0093-7335 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, COATED PELLETS ORAL 20090417 ANDA ANDA076575 Teva Pharmaceuticals USA Inc TOPIRAMATE 15 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0093-7336_d7dd5635-0975-4193-84b1-4302055fa200 0093-7336 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, COATED PELLETS ORAL 20090417 ANDA ANDA076575 Teva Pharmaceuticals USA Inc TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0093-7338_7d58a348-e8c2-4c12-a274-a4be6b657b46 0093-7338 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100427 20151231 ANDA ANDA077630 Teva Pharmaceuticals USA Inc TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0093-7350_b944787d-4dc0-4086-a5aa-e5beafa6e37d 0093-7350 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091111 ANDA ANDA077255 Teva Pharmaceuticals USA Inc LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0093-7351_b944787d-4dc0-4086-a5aa-e5beafa6e37d 0093-7351 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091111 ANDA ANDA077255 Teva Pharmaceuticals USA Inc LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0093-7355_dc6e4a24-fddf-42e2-b295-c4e24055d69d 0093-7355 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20061215 ANDA ANDA076511 Teva Pharmaceuticals USA Inc FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 0093-7364_74e5949f-269f-448e-9b76-68e70b97e46b 0093-7364 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Teva Pharmaceuticals USA Inc LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0093-7365_74e5949f-269f-448e-9b76-68e70b97e46b 0093-7365 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Teva Pharmaceuticals USA Inc LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0093-7366_74e5949f-269f-448e-9b76-68e70b97e46b 0093-7366 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Teva Pharmaceuticals USA Inc LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0093-7367_a17dfbe6-22ad-46e9-80f1-331e3535be17 0093-7367 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100406 ANDA ANDA077157 Teva Pharmaceuticals USA Inc HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0093-7368_a17dfbe6-22ad-46e9-80f1-331e3535be17 0093-7368 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100406 ANDA ANDA077157 Teva Pharmaceuticals USA Inc HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0093-7369_a17dfbe6-22ad-46e9-80f1-331e3535be17 0093-7369 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100406 ANDA ANDA077157 Teva Pharmaceuticals USA Inc HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0093-7370_baaa3048-da88-4c85-9f9f-f83c901a7fc5 0093-7370 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20070521 ANDA ANDA077179 Teva Pharmaceuticals USA Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0093-7371_baaa3048-da88-4c85-9f9f-f83c901a7fc5 0093-7371 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20070521 ANDA ANDA077179 Teva Pharmaceuticals USA Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0093-7372_baaa3048-da88-4c85-9f9f-f83c901a7fc5 0093-7372 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20070521 ANDA ANDA077179 Teva Pharmaceuticals USA Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0093-7373_baaa3048-da88-4c85-9f9f-f83c901a7fc5 0093-7373 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20070521 ANDA ANDA077179 Teva Pharmaceuticals USA Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0093-7380_36292521-33b7-4167-97e3-40bdf91c8970 0093-7380 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20060804 ANDA ANDA076690 Teva Pharmaceuticals USA Inc VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-7381_36292521-33b7-4167-97e3-40bdf91c8970 0093-7381 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20060804 ANDA ANDA076690 Teva Pharmaceuticals USA Inc VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-7382_36292521-33b7-4167-97e3-40bdf91c8970 0093-7382 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20060804 ANDA ANDA076690 Teva Pharmaceuticals USA Inc VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-7383_36292521-33b7-4167-97e3-40bdf91c8970 0093-7383 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20060804 ANDA ANDA076690 Teva Pharmaceuticals USA Inc VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-7384_081cfdef-2c53-44be-956b-de321df37adf 0093-7384 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Teva Pharmaceuticals USA Inc VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-7385_081cfdef-2c53-44be-956b-de321df37adf 0093-7385 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Teva Pharmaceuticals USA Inc VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-7386_081cfdef-2c53-44be-956b-de321df37adf 0093-7386 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Teva Pharmaceuticals USA Inc VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-7387_a33b594f-866d-4824-8690-0b4b1876f793 0093-7387 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride TABLET, FILM COATED ORAL 20140219 ANDA ANDA077437 Teva Pharmaceuticals USA Inc MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0093-7392_77563e0c-ff7b-4362-948f-cf7f814af488 0093-7392 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20130920 ANDA ANDA076378 Teva Pharmaceuticals USA Inc NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 0093-7393_77563e0c-ff7b-4362-948f-cf7f814af488 0093-7393 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20130920 ANDA ANDA076378 Teva Pharmaceuticals USA Inc NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 0093-7394_77563e0c-ff7b-4362-948f-cf7f814af488 0093-7394 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20130920 ANDA ANDA076250 Teva Pharmaceuticals USA Inc NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 0093-7424_3c314c4d-ea2d-456a-bff9-ecf46e1fb77f 0093-7424 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA078723 Teva Pharmaceuticals USA Inc MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0093-7425_3c314c4d-ea2d-456a-bff9-ecf46e1fb77f 0093-7425 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA078723 Teva Pharmaceuticals USA Inc MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0093-7426_3c314c4d-ea2d-456a-bff9-ecf46e1fb77f 0093-7426 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA078605 Teva Pharmaceuticals USA Inc MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0093-7436_73de05fa-7471-4c50-81f4-04617626bab4 0093-7436 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080624 ANDA ANDA077470 Teva Pharmaceuticals USA Inc RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0093-7437_73de05fa-7471-4c50-81f4-04617626bab4 0093-7437 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080624 ANDA ANDA077470 Teva Pharmaceuticals USA Inc RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0093-7438_73de05fa-7471-4c50-81f4-04617626bab4 0093-7438 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080624 ANDA ANDA077470 Teva Pharmaceuticals USA Inc RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0093-7439_c26979a8-2fbf-48f5-b91e-707efa7c9ef5 0093-7439 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA076941 Teva Pharmaceuticals USA Inc DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0093-7440_c26979a8-2fbf-48f5-b91e-707efa7c9ef5 0093-7440 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA076941 Teva Pharmaceuticals USA Inc DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0093-7441_c26979a8-2fbf-48f5-b91e-707efa7c9ef5 0093-7441 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA076941 Teva Pharmaceuticals USA Inc DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0093-7442_acd656cf-3edc-499c-9630-17ac45753572 0093-7442 HUMAN PRESCRIPTION DRUG Fluvastatin Fluvastatin CAPSULE ORAL 20120705 ANDA ANDA078407 Teva Pharmaceuticals USA Inc FLUVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0093-7443_acd656cf-3edc-499c-9630-17ac45753572 0093-7443 HUMAN PRESCRIPTION DRUG Fluvastatin Fluvastatin CAPSULE ORAL 20120705 ANDA ANDA078407 Teva Pharmaceuticals USA Inc FLUVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0093-7455_7932ca17-c49a-4e57-856b-11792c08a03c 0093-7455 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051028 ANDA ANDA077270 Teva Pharmaceuticals USA Inc GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0093-7456_7932ca17-c49a-4e57-856b-11792c08a03c 0093-7456 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051028 ANDA ANDA077270 Teva Pharmaceuticals USA Inc GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0093-7457_7932ca17-c49a-4e57-856b-11792c08a03c 0093-7457 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051028 ANDA ANDA077270 Teva Pharmaceuticals USA Inc GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0093-7464_641dffac-cf63-4489-8d71-38cd5fc4f7ca 0093-7464 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120330 ANDA ANDA077159 Teva Pharmaceuticals USA Inc IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0093-7465_641dffac-cf63-4489-8d71-38cd5fc4f7ca 0093-7465 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120330 ANDA ANDA077159 Teva Pharmaceuticals USA Inc IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0093-7471_a0d43bf3-1147-4e85-98fe-f410b8bb1583 0093-7471 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20130212 ANDA ANDA077263 Teva Pharmaceuticals USA Inc RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0093-7472_a0d43bf3-1147-4e85-98fe-f410b8bb1583 0093-7472 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20130212 ANDA ANDA077263 Teva Pharmaceuticals USA Inc RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0093-7473_1cb3211c-4ed2-4821-a8cd-8d8c45a0470d 0093-7473 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20140307 ANDA ANDA091649 Teva Pharmaceuticals USA Inc CAPECITABINE 150 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0093-7474_1cb3211c-4ed2-4821-a8cd-8d8c45a0470d 0093-7474 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20140307 ANDA ANDA091649 Teva Pharmaceuticals USA Inc CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0093-7477_930ada08-007e-429d-94d9-55682868a380 0093-7477 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET, FILM COATED ORAL 20090505 ANDA ANDA065457 Teva Pharmaceuticals USA Inc MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 0093-7485_c26b1649-abca-4ec1-88d6-3e6a1c69864a 0093-7485 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride TABLET, FILM COATED ORAL 20080102 ANDA ANDA078080 Teva Pharmaceuticals USA Inc GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0093-7493_e6ff7b7e-4271-4a6d-b65f-53200b0169f6 0093-7493 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078101 Teva Pharmaceuticals USA Inc LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0093-7514_641dffac-cf63-4489-8d71-38cd5fc4f7ca 0093-7514 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20130510 ANDA ANDA077159 Teva Pharmaceuticals USA Inc IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0093-7528_56db4c73-a95f-4233-8a32-66c7cd19e652 0093-7528 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20141216 ANDA ANDA065155 Teva Pharmaceuticals USA Inc CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0093-7529_56db4c73-a95f-4233-8a32-66c7cd19e652 0093-7529 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20141216 ANDA ANDA065155 Teva Pharmaceuticals USA Inc CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0093-7536_327d6dd3-df90-41ca-bf77-8426c40c791a 0093-7536 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, FILM COATED ORAL 20100628 ANDA ANDA078058 Teva Pharmaceuticals USA Inc ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 0093-7540_8251c4c2-9c4a-4a5c-afdc-eba2811bf48f 0093-7540 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20090331 ANDA ANDA076317 Teva Pharmaceuticals USA Inc TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0093-7542_e789db2e-95e7-4018-986a-87107582331d 0093-7542 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090783 Teva Pharmaceuticals USA Inc DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-7543_e789db2e-95e7-4018-986a-87107582331d 0093-7543 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090783 Teva Pharmaceuticals USA Inc DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-7544_e789db2e-95e7-4018-986a-87107582331d 0093-7544 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090783 Teva Pharmaceuticals USA Inc DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0093-7599_503bd25c-a44f-47ab-9ef5-1cdb8fd89214 0093-7599 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 ANDA ANDA078879 Teva Pharmaceuticals USA Inc TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0093-7600_503bd25c-a44f-47ab-9ef5-1cdb8fd89214 0093-7600 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 ANDA ANDA078879 Teva Pharmaceuticals USA Inc TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0093-7601_503bd25c-a44f-47ab-9ef5-1cdb8fd89214 0093-7601 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 ANDA ANDA078879 Teva Pharmaceuticals USA Inc TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0093-7602_503bd25c-a44f-47ab-9ef5-1cdb8fd89214 0093-7602 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 ANDA ANDA078879 Teva Pharmaceuticals USA Inc TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0093-7618_59a1ac24-f723-41e0-b938-79bd70d22a73 0093-7618 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride Dorzolamide Hydrochloride SOLUTION OPHTHALMIC 20100128 ANDA ANDA078756 Teva Pharmaceuticals USA Inc DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] 0093-7620_b76f97ca-f892-4b31-ad28-6e0f016fd559 0093-7620 HUMAN PRESCRIPTION DRUG Letrozole Letrozole TABLET, FILM COATED ORAL 20110603 ANDA ANDA090289 Teva Pharmaceuticals USA Inc LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 0093-7638_503bd25c-a44f-47ab-9ef5-1cdb8fd89214 0093-7638 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 ANDA ANDA078879 Teva Pharmaceuticals USA Inc TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0093-7639_503bd25c-a44f-47ab-9ef5-1cdb8fd89214 0093-7639 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 ANDA ANDA078879 Teva Pharmaceuticals USA Inc TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0093-7656_ba173664-ed94-4009-9119-44f444ffdec3 0093-7656 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20130930 ANDA ANDA090829 Teva Pharmaceuticals USA Inc PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0093-7657_ba173664-ed94-4009-9119-44f444ffdec3 0093-7657 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20130930 ANDA ANDA090829 Teva Pharmaceuticals USA Inc PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0093-7658_ba173664-ed94-4009-9119-44f444ffdec3 0093-7658 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20130930 ANDA ANDA090829 Teva Pharmaceuticals USA Inc PARICALCITOL 4 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0093-7670_baaa3048-da88-4c85-9f9f-f83c901a7fc5 0093-7670 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20110720 ANDA ANDA077179 Teva Pharmaceuticals USA Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0093-7671_baaa3048-da88-4c85-9f9f-f83c901a7fc5 0093-7671 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20110720 ANDA ANDA077179 Teva Pharmaceuticals USA Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0093-7701_6f9985e0-3b59-4146-aa9c-81d059245cee 0093-7701 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET, FILM COATED ORAL 20110906 ANDA ANDA090199 Teva Pharmaceuticals USA Inc LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0093-7772_1c56e83b-8de2-4b41-9e3f-30896e3a192b 0093-7772 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20090918 ANDA ANDA074949 Teva Pharmaceuticals USA Inc CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] 0093-7795_72ba1bc5-cae0-4e36-a5c4-1037fda21c1c 0093-7795 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110914 ANDA ANDA091430 Teva Pharmaceuticals USA Inc LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0093-7796_72ba1bc5-cae0-4e36-a5c4-1037fda21c1c 0093-7796 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110914 ANDA ANDA091430 Teva Pharmaceuticals USA Inc LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0093-7807_1d8398fe-6389-4e11-9e55-71508cb33475 0093-7807 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan, and Hydrochlorothiazide Amlodipine, Valsartan, and Hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 ANDA ANDA200435 Teva Pharmaceuticals USA Inc AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5; 12.5; 160 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0093-7809_1d8398fe-6389-4e11-9e55-71508cb33475 0093-7809 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan, and Hydrochlorothiazide Amlodipine, Valsartan, and Hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 ANDA ANDA200435 Teva Pharmaceuticals USA Inc AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10; 25; 320 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0093-7810_1d8398fe-6389-4e11-9e55-71508cb33475 0093-7810 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan, and Hydrochlorothiazide Amlodipine, Valsartan, and Hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 ANDA ANDA200435 Teva Pharmaceuticals USA Inc AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10; 12.5; 160 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0093-8034_3eed9b03-e24f-4fff-be1c-636c63db2f5f 0093-8034 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19990511 ANDA ANDA074686 Teva Pharmaceuticals USA Inc GLYBURIDE 1.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0093-8035_3eed9b03-e24f-4fff-be1c-636c63db2f5f 0093-8035 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19990511 ANDA ANDA074686 Teva Pharmaceuticals USA Inc GLYBURIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0093-8036_3eed9b03-e24f-4fff-be1c-636c63db2f5f 0093-8036 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19990512 ANDA ANDA074686 Teva Pharmaceuticals USA Inc GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0093-8055_67f59b66-704b-445a-b06a-46501c3e4b16 0093-8055 HUMAN PRESCRIPTION DRUG Lansoprazole Amoxicillin Clarithromycin Lansoprazole Amoxicillin Clarithromycin KIT 20130909 ANDA ANDA200218 Teva Pharmaceuticals USA Inc 0093-8117_ae8b7487-813b-47aa-9bc3-d6251c67d3c4 0093-8117 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20070905 ANDA ANDA077487 Teva Pharmaceuticals USA Inc FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0093-8118_ae8b7487-813b-47aa-9bc3-d6251c67d3c4 0093-8118 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20070905 ANDA ANDA077487 Teva Pharmaceuticals USA Inc FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0093-8119_ae8b7487-813b-47aa-9bc3-d6251c67d3c4 0093-8119 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20070905 ANDA ANDA077487 Teva Pharmaceuticals USA Inc FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0093-8120_63ce3abd-f084-4c3e-bad0-27b800983a66 0093-8120 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20001020 ANDA ANDA075536 Teva Pharmaceuticals USA Inc DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0093-8121_63ce3abd-f084-4c3e-bad0-27b800983a66 0093-8121 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20001020 ANDA ANDA075536 Teva Pharmaceuticals USA Inc DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0093-8122_63ce3abd-f084-4c3e-bad0-27b800983a66 0093-8122 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20001020 ANDA ANDA075536 Teva Pharmaceuticals USA Inc DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0093-8123_63ce3abd-f084-4c3e-bad0-27b800983a66 0093-8123 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20001020 ANDA ANDA075536 Teva Pharmaceuticals USA Inc DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0093-8161_74eacde3-1c55-4071-af37-af34a0c5682d 0093-8161 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 20150430 ANDA ANDA077745 Teva Pharmaceuticals USA Inc QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 0093-8162_8bd44d47-53c8-4e20-b827-dbca04bcc3f7 0093-8162 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 Teva Pharmaceuticals USA Inc QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 0093-8163_8bd44d47-53c8-4e20-b827-dbca04bcc3f7 0093-8163 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 Teva Pharmaceuticals USA Inc QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 0093-8164_8bd44d47-53c8-4e20-b827-dbca04bcc3f7 0093-8164 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 Teva Pharmaceuticals USA Inc QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 0093-8165_8bd44d47-53c8-4e20-b827-dbca04bcc3f7 0093-8165 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 Teva Pharmaceuticals USA Inc QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 0093-8166_8bd44d47-53c8-4e20-b827-dbca04bcc3f7 0093-8166 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 Teva Pharmaceuticals USA Inc QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 0093-8192_8314bb76-fae2-4935-a6f0-1bcf9d8aa8d0 0093-8192 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20031124 ANDA ANDA074151 Teva Pharmaceuticals USA Inc CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0093-8204_8314bb76-fae2-4935-a6f0-1bcf9d8aa8d0 0093-8204 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20040202 ANDA ANDA074151 Teva Pharmaceuticals USA Inc CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0093-8232_77fef6e2-fd71-4e1d-900c-e3c07dc9dfb9 0093-8232 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130827 ANDA ANDA077369 Teva Pharmaceuticals USA Inc HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0093-8238_77fef6e2-fd71-4e1d-900c-e3c07dc9dfb9 0093-8238 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130124 ANDA ANDA077369 Teva Pharmaceuticals USA Inc HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0093-8305_8314bb76-fae2-4935-a6f0-1bcf9d8aa8d0 0093-8305 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20031206 ANDA ANDA074463 Teva Pharmaceuticals USA Inc CIMETIDINE 800 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0093-8342_2b9040f2-68e4-48b5-80a9-ff7483e9f3c4 0093-8342 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Teva Pharmaceuticals USA Inc GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0093-8343_2b9040f2-68e4-48b5-80a9-ff7483e9f3c4 0093-8343 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Teva Pharmaceuticals USA Inc GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0093-8344_2b9040f2-68e4-48b5-80a9-ff7483e9f3c4 0093-8344 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Teva Pharmaceuticals USA Inc GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0093-8522_7a8cb2cd-47ed-477f-99b2-63982bfbf935 0093-8522 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET, FILM COATED ORAL 20130812 ANDA ANDA078751 Teva Pharmaceuticals USA Inc NARATRIPTAN HYDROCHLORIDE 1 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0093-8523_7a8cb2cd-47ed-477f-99b2-63982bfbf935 0093-8523 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET, FILM COATED ORAL 20130809 ANDA ANDA078751 Teva Pharmaceuticals USA Inc NARATRIPTAN HYDROCHLORIDE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0093-8675_4c5ea014-9404-47c7-94de-9da15dc602ec 0093-8675 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20040923 ANDA ANDA065162 Teva Pharmaceuticals USA Inc AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0093-8739_6ccbead8-34a8-4ca8-9d99-0a8ad6f799b7 0093-8739 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 19950605 ANDA ANDA074377 Teva Pharmaceuticals USA Inc MEXILETINE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] 0093-8740_6ccbead8-34a8-4ca8-9d99-0a8ad6f799b7 0093-8740 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 19950605 ANDA ANDA074377 Teva Pharmaceuticals USA Inc MEXILETINE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC] 0093-8741_6ccbead8-34a8-4ca8-9d99-0a8ad6f799b7 0093-8741 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 19950605 ANDA ANDA074377 Teva Pharmaceuticals USA Inc MEXILETINE HYDROCHLORIDE 250 mg/1 Antiarrhythmic [EPC] 0093-8940_5f18e8b0-0262-4fdd-b6ad-e5dedbae1af1 0093-8940 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 19970423 ANDA ANDA074578 Teva Pharmaceuticals USA Inc ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0093-8943_5f18e8b0-0262-4fdd-b6ad-e5dedbae1af1 0093-8943 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970423 ANDA ANDA074556 Teva Pharmaceuticals USA Inc ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0093-8947_5f18e8b0-0262-4fdd-b6ad-e5dedbae1af1 0093-8947 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970430 ANDA ANDA074556 Teva Pharmaceuticals USA Inc ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0093-9133_2177ba12-8777-4f80-be67-c75bc16ac5e4 0093-9133 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 19981130 ANDA ANDA074739 Teva Pharmaceuticals USA Inc AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0093-9175_4f15a822-c86d-4160-a6b6-06f1ce017fc7 0093-9175 HUMAN PRESCRIPTION DRUG Quinidine Sulfate Quinidine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19950101 ANDA ANDA040045 Teva Pharmaceuticals USA Inc QUINIDINE SULFATE 300 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] 0093-9364_7322959e-7269-43b8-835b-96ec22432891 0093-9364 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19840501 NDA AUTHORIZED GENERIC NDA017532 TEVA Pharmaceuticals USA Inc GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0093-9433_7322959e-7269-43b8-835b-96ec22432891 0093-9433 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19840501 NDA AUTHORIZED GENERIC NDA017532 TEVA Pharmaceuticals USA Inc GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0093-9477_7322959e-7269-43b8-835b-96ec22432891 0093-9477 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19840501 NDA AUTHORIZED GENERIC NDA017532 TEVA Pharmaceuticals USA Inc GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0093-9604_27b7bf00-4206-4d5b-87c9-3c890cf108a0 0093-9604 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol lactate SOLUTION, CONCENTRATE ORAL 19881201 ANDA ANDA071617 Teva Pharmaceuticals USA Inc HALOPERIDOL LACTATE 2 mg/mL Typical Antipsychotic [EPC] 0093-9612_7917de8e-e717-47ad-9633-9d125816edef 0093-9612 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride SOLUTION, CONCENTRATE ORAL 19871106 ANDA ANDA071609 Teva Pharmaceuticals USA Inc DOXEPIN HYDROCHLORIDE 10 mg/mL Tricyclic Antidepressant [EPC] 0093-9614_712e3cc8-d6af-4c78-99a1-e9ee44c062cd 0093-9614 HUMAN PRESCRIPTION DRUG Silver Nitrate Silver Nitrate SOLUTION TOPICAL 19910101 UNAPPROVED DRUG OTHER Teva Pharmaceuticals USA Inc SILVER NITRATE .005 g/mL 0093-9643_6a98a1ea-d344-4655-9291-13cebf1b537b 0093-9643 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960725 ANDA ANDA040120 Teva Pharmaceuticals USA Inc PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0093-9652_6a98a1ea-d344-4655-9291-13cebf1b537b 0093-9652 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960725 ANDA ANDA040120 Teva Pharmaceuticals USA Inc PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0093-9660_55b2fc61-dabd-435f-839d-e03c09b4b060 0093-9660 HUMAN PRESCRIPTION DRUG Ethosuximide Ethosuximide SOLUTION ORAL 19940701 ANDA ANDA081306 Teva Pharmaceuticals USA Inc ETHOSUXIMIDE 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0095-0049_8d08ceaf-d1a9-4352-9046-111b5aa4e80d 0095-0049 HUMAN PRESCRIPTION DRUG Cormax Clobetasol Propionate SOLUTION TOPICAL 20120705 ANDA ANDA074222 ECR Pharmaceuticals Co., Inc. CLOBETASOL PROPIONATE .4625 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0095-0054_90422d3d-7d40-4e38-a17c-ce77715bdbf8 0095-0054 HUMAN PRESCRIPTION DRUG TussiCaps hydrocodone polistirex and chlorpheniramine polistirex CAPSULE, EXTENDED RELEASE ORAL 20110902 ANDA ANDA077273 ECR Pharmaceuticals CHLORPHENIRAMINE; HYDROCODONE 4; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CIII 0095-0073_49a31634-a2f7-46fa-ba93-fb2e5d99c0e4 0095-0073 HUMAN PRESCRIPTION DRUG HYLASE Wound Sodium Hyaluronate GEL TOPICAL 20120106 UNAPPROVED DRUG OTHER ECR Pharmaceuticals Co., Inc. HYALURONATE SODIUM 2.5 g/100g 0095-0086_7021a1c8-d2b4-455d-b6fd-4d2658b7b55b 0095-0086 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20090401 ANDA ANDA040700 ECR Pharmaceuticals DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0095-0087_e5b4a757-8a3a-4d1d-ad7e-8dda8df0234e 0095-0087 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20060901 ANDA ANDA040700 ECR Pharmaceuticals DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0095-0088_e228f669-e488-4930-a03e-1358ccfd8c83 0095-0088 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20000401 ANDA ANDA040700 ECR Pharmaceuticals DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0095-0089_67c356da-eeea-4fdd-8231-df03f3ee2c56 0095-0089 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20090401 ANDA ANDA040700 ECR Pharmaceuticals DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0095-0108_90422d3d-7d40-4e38-a17c-ce77715bdbf8 0095-0108 HUMAN PRESCRIPTION DRUG TussiCaps hydrocodone polistirex and chlorpheniramine polistirex CAPSULE, EXTENDED RELEASE ORAL 20110902 ANDA ANDA077273 ECR Pharmaceuticals CHLORPHENIRAMINE; HYDROCODONE 8; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CIII 0095-0201_1c6c2a83-33de-4992-8091-33d54c1bd0c6 0095-0201 HUMAN PRESCRIPTION DRUG VoSoL HC hydrocortisone and acetic acid SOLUTION AURICULAR (OTIC) 20090622 NDA NDA012770 ECR Pharmaceuticals Co., Inc. ACETIC ACID; HYDROCORTISONE 20.75; 10.375 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0095-0202_39de0239-a4f6-45b0-a3cf-c6fba941c08e 0095-0202 HUMAN PRESCRIPTION DRUG VoSoL acetic acid SOLUTION AURICULAR (OTIC) 20100315 NDA NDA012179 ECR Pharmaceuticals Co., Inc. ACETIC ACID 20.65 mg/mL 0095-0674_5b67d708-f4ca-4e40-ba2e-7d9348c8dbcc 0095-0674 HUMAN PRESCRIPTION DRUG Zolvit hydrocodone bitartrate and acetaminophen SOLUTION ORAL 20120101 ANDA ANDA040881 ECR Pharmaceuticals Co., Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 10 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0095-0860_cc61a3af-f08d-4ab1-8ec2-0f5d86182089 0095-0860 HUMAN OTC DRUG Lodrane D brompheniramine maleate and pseudoephedrine hydrochloride CAPSULE ORAL 20111021 OTC MONOGRAPH FINAL part341 ECR Pharmaceuticals BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 60 mg/1; mg/1 0095-0950_f7e9e48b-b2be-4bb7-bfce-777b33e0f112 0095-0950 HUMAN PRESCRIPTION DRUG Zolpimist zolpidem tartrate SPRAY, METERED ORAL 20101201 NDA NDA022196 ECR Pharmaceuticals ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0095-3000_5076f608-70b9-4786-b33c-0bba73be6e63 0095-3000 HUMAN PRESCRIPTION DRUG BUPAP Butalbital and Acetaminophen Tablets TABLET ORAL 20130624 ANDA ANDA090956 ECR Pharmaceuticals ACETAMINOPHEN; BUTALBITAL 300; 50 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] CIII 0095-9090_6eeaec7c-4f77-4abf-8f08-9af4afd08c84 0095-9090 HUMAN PRESCRIPTION DRUG Lortab hydrocodone bitartrate and acetaminophen SYRUP ORAL 20130925 ANDA ANDA040881 ECR Pharmaceuticals ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 10 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0096-0682_8fc3afb4-bc36-4df1-a205-61c3a028df52 0096-0682 HUMAN OTC DRUG Solbar Shield SPF40 Solbar Shield SPF40 CREAM TOPICAL 19960601 OTC MONOGRAPH FINAL part352 Person and Covey TITANIUM DIOXIDE; ZINC OXIDE .05; .075 g/g; g/g 0096-0685_51ba9fe6-6686-43e5-8c96-c27cf25aadc8 0096-0685 HUMAN OTC DRUG Solbar Thirty SPF 30 Solbar Thirty SPF30 CREAM TOPICAL 19960601 OTC MONOGRAPH FINAL part352 Person and Covey AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE .03; .12; .075; .015; .06 g/g; g/g; g/g; g/g; g/g 0096-0687_a5aacdda-3128-4ba6-b613-c46201490ad1 0096-0687 HUMAN OTC DRUG Solbar Avo SPF35 Solbar Avo SPF35 CREAM TOPICAL 19960601 OTC MONOGRAPH FINAL part352 Person and Covey AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYBENZONE .03; .08; .075; .06 g/g; g/g; g/g; g/g 0096-0688_2aeca9c6-3eb5-4ceb-b023-9d91e4259848 0096-0688 HUMAN OTC DRUG Solbar Zinc SPF38 Solbar Zinc SPF38 CREAM TOPICAL 19960601 OTC MONOGRAPH FINAL part352 Person and Covey HOMOSALATE; OCTINOXATE; ZINC OXIDE .1015; .077; .077 1/g; 1/g; 1/g 0096-0709_fe74bb41-d2d1-4f03-9154-0afe36811499 0096-0709 HUMAN OTC DRUG Xerac AC Xerac AC LIQUID TOPICAL 19960601 OTC MONOGRAPH FINAL part350 Person and Covey ALUMINUM CHLORIDE .0625 g/g 0096-0736_e6418e4b-22e0-4da9-9ebe-52507c98b54e 0096-0736 HUMAN OTC DRUG DHS TAR GEL 8 oz DHS TAR GEL SHAMPOO TOPICAL 19960601 OTC MONOGRAPH FINAL part358H Person and Covey COAL TAR .005 g/g 0096-0737_bc619ce2-35ee-4373-b56b-21d7d96e21fd 0096-0737 HUMAN OTC DRUG DHS TAR coal tar SHAMPOO TOPICAL 19950601 OTC MONOGRAPH FINAL part358H Person and Covey COAL TAR .005 g/g 0096-0738_2d56db87-d7b7-423c-b0f4-249f27eca779 0096-0738 HUMAN OTC DRUG DHS SAL 4 oz. DHS SAL SHAMPOO TOPICAL 19950601 OTC MONOGRAPH FINAL part333D Person and Covey SALICYLIC ACID .035 g/g 0096-0741_1a5d1b15-73ff-4bf1-a088-72831fb48032 0096-0741 HUMAN OTC DRUG Solbar Fifty SPF50 Solbar Fifty SPF50 CREAM TOPICAL 19960601 OTC MONOGRAPH FINAL part352 Solbar Fifty SPF 50 AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE .011; .08; .1; .06 g/g; g/g; g/g; g/g 0113-0002_a228f77a-ea23-41d7-937a-535bf77ee55d 0113-0002 HUMAN OTC DRUG good sense enema Saline ENEMA RECTAL 20091123 OTC MONOGRAPH NOT FINAL part334 L Perrigo Company SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 0113-0008_ed11da35-0e92-46c8-b255-b748de0e848e 0113-0008 HUMAN OTC DRUG good sense pain relief infants concentrated Acetaminophen SUSPENSION/ DROPS ORAL 19900815 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ACETAMINOPHEN 80 mg/.8mL 0113-0013_820f9c74-1a77-4050-b065-6542d3459934 0113-0013 HUMAN OTC DRUG good sense allergy and congestion relief Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120404 ANDA ANDA076050 L Perrigo Company LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 0113-0014_4339b464-c6d0-4955-afde-55fd303c431d 0113-0014 HUMAN OTC DRUG good sense cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20100901 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 0113-0020_bfb7ef35-1fa9-4e58-89dc-4957c8b5ec07 0113-0020 HUMAN OTC DRUG good sense childrens pain and fever Acetaminophen SUSPENSION ORAL 20140320 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL 0113-0022_f78c4813-0036-4d3b-8339-8eb00026c50c 0113-0022 HUMAN OTC DRUG Good Sense Heartburn Relief Cimetidine TABLET ORAL 20021230 ANDA ANDA075285 L. Perrigo Company CIMETIDINE 200 mg/1 0113-0027_41383480-69f4-4b21-936f-88c7df91f8c7 0113-0027 HUMAN OTC DRUG good sense allergy eye Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 19971118 ANDA ANDA077958 L Perrigo Company KETOTIFEN FUMARATE .25 mg/mL 0113-0029_845e2477-7356-49b0-a625-126add45e0b8 0113-0029 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050506 ANDA ANDA076775 L. Perrigo Company NICOTINE 2 mg/1 0113-0041_a64323a5-7d68-48f2-ad8d-7050166b44d2 0113-0041 HUMAN OTC DRUG Good Sense Night Time acetaminophen, dextromethorphan hydrobromide, doxylamine succinate LIQUID ORAL 20060407 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 0113-0046_550b962a-16a9-421a-bd3d-6647482f7856 0113-0046 HUMAN OTC DRUG Good Sense Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20090828 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ACETAMINOPHEN 500 mg/1 0113-0047_61c143ea-eb38-4f96-8e05-6008a73f8573 0113-0047 HUMAN OTC DRUG Acid Reducer Maximum Strength Ranitidine TABLET ORAL 20080219 ANDA ANDA078653 L. Perrigo Company RANITIDINE HYDROCHLORIDE 150 mg/1 0113-0049_6e278630-34b4-4ee4-85f0-256db31b28eb 0113-0049 HUMAN OTC DRUG Good Sense Muscle Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20090324 OTC MONOGRAPH NOT FINAL part348 L Perrigo Company CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g 0113-0050_5067128f-f2d8-446b-bdcc-790c87c1bd80 0113-0050 HUMAN OTC DRUG good sense ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090305 ANDA ANDA079113 L Perrigo Company DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 0113-0052_586a738e-fbce-4131-b527-24323a9e4158 0113-0052 HUMAN OTC DRUG good sense sleep time Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140206 OTC MONOGRAPH FINAL part338 L. Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0113-0054_1de8a7f6-e7bb-437d-8794-c4b9f43b89c9 0113-0054 HUMAN OTC DRUG Good Sense Suphedrine 12 Hour Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19991029 ANDA ANDA075153 L Perrigo Company PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 0113-0056_e47dffdf-5778-4804-8ce2-54c5a72bba3a 0113-0056 HUMAN OTC DRUG good sense night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140530 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 0113-0057_c79e65e7-149b-450f-b083-99e16ff71729 0113-0057 HUMAN OTC DRUG Good Sense ibuprofen infants ibuprofen SUSPENSION ORAL 20000208 ANDA ANDA075217 L Perrigo Company IBUPROFEN 50 mg/1.25mL 0113-0061_00510548-f6e7-47b5-847b-a12eb14cda85 0113-0061 HUMAN OTC DRUG good sense tussin mucus and chest congestion Guaifenesin SYRUP ORAL 19910115 OTC MONOGRAPH FINAL part341 L. Perrigo Company GUAIFENESIN 200 mg/10mL 0113-0065_b185b1ed-881d-4eaf-b34b-7ebe0dcfcbf6 0113-0065 HUMAN OTC DRUG good sense nasal Oxymetazoline HCl SPRAY NASAL 19940323 OTC MONOGRAPH FINAL part341 L Perrigo Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 0113-0067_f3d7dfe5-6c1c-46bd-bfb3-48e12b2fee6f 0113-0067 HUMAN OTC DRUG Good Sense Triple Antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20060208 OTC MONOGRAPH FINAL part333B L Perrigo Company BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 0113-0074_19239a12-d915-40b3-8a6a-e326d3c733c6 0113-0074 HUMAN OTC DRUG Good Sense ibuprofen Ibuprofen TABLET, COATED ORAL 20060310 ANDA ANDA077349 L Perrigo Company IBUPROFEN 200 mg/1 0113-0081_9aeac709-001b-4617-8046-186264847ec8 0113-0081 HUMAN OTC DRUG Good Sense Miconazole 3 Miconazole nitrate KIT 20070402 ANDA ANDA075329 L Perrigo Company 0113-0083_f273a521-1292-40b0-9d41-3522677705ca 0113-0083 HUMAN OTC DRUG good sense ibuprofen cold and sinus Ibuprofen, Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011009 ANDA ANDA074567 L Perrigo Company IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 0113-0084_3eadd35c-3df2-4e46-b76d-a6e537895917 0113-0084 HUMAN OTC DRUG Good Sense First Aid Antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20140428 OTC MONOGRAPH FINAL part333B L. Perrigo Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 0113-0090_4e9a64de-2922-4015-9588-4e8362c4dbb6 0113-0090 HUMAN OTC DRUG good sense DayTime Night Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110610 OTC MONOGRAPH FINAL part341 L Perrigo Company 0113-0090_7653f12e-5476-4a6c-a8e9-15b9c752c851 0113-0090 HUMAN OTC DRUG good sense daytime nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20101117 OTC MONOGRAPH FINAL part341 L Perrigo Company 0113-0094_c1f9fddf-216a-42eb-9d2c-29d1bb87b5ab 0113-0094 HUMAN OTC DRUG Good Sense Nasal Decongestant PE Phenylephrine Hydrochloride TABLET ORAL 20050621 OTC MONOGRAPH FINAL part341 L. Perrigo Company PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 0113-0096_50c53794-0d6e-400d-b0c0-7e9fd8fa90aa 0113-0096 HUMAN OTC DRUG good sense flu and severe cold and cough daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20110131 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 0113-0105_9fec0ce6-912b-4a47-9d81-3af1de86dddd 0113-0105 HUMAN OTC DRUG good sense pain relief childrens Acetaminophen SUSPENSION ORAL 19960515 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ACETAMINOPHEN 160 mg/5mL 0113-0110_da859235-7954-4f4f-91f2-c769bd05254c 0113-0110 HUMAN OTC DRUG fresh and pure Povidone-iodine KIT 20091109 OTC MONOGRAPH NOT FINAL part333A L Perrigo Company 0113-0112_b8c8c5fa-d015-40e1-a1c7-28f4c071adaf 0113-0112 HUMAN OTC DRUG good sense nausea relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 20141103 UNAPPROVED DRUG OTHER L. Perrigo Company DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 0113-0117_0a141605-a929-47f6-84fc-8072c6415f54 0113-0117 HUMAN OTC DRUG Good Sense lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120524 ANDA ANDA202319 L. Perrigo Company LANSOPRAZOLE 15 mg/1 0113-0130_a19be8dc-e9fd-4d76-a302-de512ba1ba12 0113-0130 HUMAN OTC DRUG good sense pain relief childrens Acetaminophen SUSPENSION ORAL 19930225 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL 0113-0131_b9166777-cba8-47a4-a853-73bb34cfe1dd 0113-0131 HUMAN OTC DRUG GOOD SENSE IBUPROFEN Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100128 ANDA ANDA079205 L Perrigo Company IBUPROFEN 200 mg/1 0113-0133_fd481b7e-31a7-4b27-bd46-9d9ee11b669d 0113-0133 HUMAN OTC DRUG good sense flu and sore throat acetaminophen,pheniramine maleate, phenylephrine hydrochloride POWDER, FOR SUSPENSION ORAL 20110106 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/15000mg; mg/15000mg; mg/15000mg 0113-0139_6f6cb34d-00d6-4448-acd4-02661a788f0d 0113-0139 HUMAN OTC DRUG good sense cold and allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20061011 OTC MONOGRAPH FINAL part341 L Perrigo Company CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 0113-0141_cc77f6ff-a534-4731-b971-491280840899 0113-0141 HUMAN OTC DRUG good sense acid reducer Famotidine TABLET ORAL 20091023 ANDA ANDA075400 L Perrigo Company FAMOTIDINE 10 mg/1 0113-0142_37c664c9-4bb4-4a86-9321-3227715d5b19 0113-0142 HUMAN OTC DRUG good sense vagicaine anti itch Benzocaine, Resorcinol CREAM TOPICAL 20110726 OTC MONOGRAPH NOT FINAL part348 L Perrigo Company BENZOCAINE; RESORCINOL 20; 3 g/100g; g/100g 0113-0145_91eb9580-2367-435d-9549-97d44a8d190e 0113-0145 HUMAN OTC DRUG Good Sense Mucus Relief Cold and Sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130702 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 0113-0151_b9e0fcda-c530-4970-a8c8-722748a35f67 0113-0151 HUMAN OTC DRUG good sense nighttime sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20090902 OTC MONOGRAPH FINAL part338 L Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0113-0154_3d7d3f9d-67ec-40b6-a146-4842dc73b242 0113-0154 HUMAN OTC DRUG good sense athletes foot tolnaftate SPRAY TOPICAL 20050614 OTC MONOGRAPH FINAL part333C L Perrigo Company TOLNAFTATE 1 g/100g 0113-0160_6f85e72b-b323-4e1f-973c-5ced01564988 0113-0160 HUMAN OTC DRUG Good Sense Hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20121226 OTC MONOGRAPH FINAL part346 L. Perrigo Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g 0113-0161_fd17380a-7f5e-4b84-adf0-a9191cee8067 0113-0161 HUMAN OTC DRUG Good Sense pain and fever Acetaminophen SUSPENSION ORAL 20110921 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL 0113-0165_51edb3c8-7f23-4960-b770-ca38cd6d97ba 0113-0165 HUMAN OTC DRUG Good Sense Allergy and Congestion Relief Pseudoephedrine sulfate, Loratadine TABLET, FILM COATED ORAL 20090622 ANDA ANDA075989 L Perrigo Company LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 0113-0166_66713de4-9ec2-47f7-9866-5fe311b5e5ea 0113-0166 HUMAN OTC DRUG good sense ibuprofen childrens Ibuprofen SUSPENSION ORAL 20020504 ANDA ANDA074937 L. Perrigo Company IBUPROFEN 100 mg/5mL 0113-0170_ecb06677-2bbc-4524-8f05-44bac5473cd9 0113-0170 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050506 ANDA ANDA076789 L. Perrigo Company NICOTINE 4 mg/1 0113-0173_02390abe-962b-4eb6-90bf-1890569b3010 0113-0173 HUMAN OTC DRUG good sense complete lice treatment Piperonyl Butoxide, Pyrethrum Extract Shampoo KIT 20081119 OTC MONOGRAPH FINAL part358G L. Perrigo Company 0113-0173_631a3be8-309e-48ae-9d89-e203251ffb0f 0113-0173 HUMAN OTC DRUG Good Sense Complete Lice Treatment Piperonyl Butoxide, Pyrethrum Extract KIT 20081119 OTC MONOGRAPH FINAL part358G L. Perrigo Company 0113-0175_827aee99-5af0-4bc0-ac36-7df3578efeb3 0113-0175 HUMAN OTC DRUG good sense pain relief childrens Acetaminophen SUSPENSION ORAL 19931008 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL 0113-0176_d5883129-0650-41ef-984d-a8fc4303f5fd 0113-0176 HUMAN OTC DRUG Good Sense All Day Allergy D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080502 ANDA ANDA077170 L Perrigo Company CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 0113-0179_21e9152c-6e83-454d-a782-00c2ced5b3fa 0113-0179 HUMAN OTC DRUG good sense antacid Calcium carbonate TABLET, CHEWABLE ORAL 19950525 OTC MONOGRAPH FINAL part331 L Perrigo Company CALCIUM CARBONATE 750 mg/1 0113-0186_fdab82d5-244b-408a-95d1-8307cf32f897 0113-0186 HUMAN OTC DRUG Good Sense Sleep Time Diphenhydramine HCl SOLUTION ORAL 20130702 OTC MONOGRAPH FINAL part338 L. Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 0113-0187_18d0ba09-e230-4367-8db3-5c9c2a4e0c3b 0113-0187 HUMAN OTC DRUG good sense pain relief extra strength Acetaminophen TABLET, COATED ORAL 19941005 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ACETAMINOPHEN 500 mg/1 0113-0188_2492ee1b-01f1-46e7-8790-b6ebc48f2aff 0113-0188 HUMAN OTC DRUG Good Sense Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20131121 OTC MONOGRAPH FINAL part346 L. Perrigo Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 0113-0189_19120ef7-e9ca-435d-beab-6278b5756d6b 0113-0189 HUMAN OTC DRUG Good Sense Childrens All Day Allergy Cetirizine HCl LIQUID ORAL 20140103 ANDA ANDA204226 L. Perrigo Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 0113-0194_39cb0f15-d177-46eb-a549-7acb885fbf07 0113-0194 HUMAN OTC DRUG Good Sense Acid Reducer Famotidine TABLET ORAL 20070316 ANDA ANDA077351 L Perrigo Company FAMOTIDINE 20 mg/1 0113-0202_250461a1-aeae-4338-b5e7-8e0bb8a7cbc7 0113-0202 HUMAN OTC DRUG good sense hair regrowth treatment for women minoxidil SOLUTION TOPICAL 20120211 ANDA ANDA075357 L Perrigo Company MINOXIDIL 2 g/100mL 0113-0206_6b67ee5f-9029-4ea8-b99a-330ea74f7616 0113-0206 HUMAN OTC DRUG good sense nicotine mint Nicotine Polacrilex GUM, CHEWING ORAL 19910415 ANDA ANDA078325 L. Perrigo Company NICOTINE 2 mg/1 0113-0212_c6b79501-d08b-4430-9545-70da5f545975 0113-0212 HUMAN OTC DRUG Good Sense Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 19930225 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL 0113-0214_4902029e-47dd-483b-af03-b1b5936e98ea 0113-0214 HUMAN OTC DRUG Good Sense Miconazole 7 Miconazole nitrate CREAM VAGINAL 19990730 ANDA ANDA074760 L Perrigo Company MICONAZOLE NITRATE 2 g/100g 0113-0217_0ea68251-8ebc-4da1-9d89-ec37acc23680 0113-0217 HUMAN OTC DRUG good sense pain relief 8 hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060213 ANDA ANDA075077 L. Perrigo Company ACETAMINOPHEN 650 mg/1 0113-0224_9c1d811d-f8d0-418c-aaf7-7b6477deea20 0113-0224 HUMAN OTC DRUG Good Sense anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030225 ANDA ANDA075232 L Perrigo Company LOPERAMIDE HYDROCHLORIDE 2 mg/1 0113-0227_3dc530c9-60d2-4ef0-8a3a-0ee605dd39cb 0113-0227 HUMAN OTC DRUG Good Sense Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20060213 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 500 mg/1 0113-0234_51efc779-f78c-416a-bd91-d1dba2b65695 0113-0234 HUMAN OTC DRUG good sense cold head congestion severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20080223 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 0113-0259_cf9c4e4a-11e6-4108-ac3b-7838ca5e799b 0113-0259 HUMAN OTC DRUG good sense aspirin Aspirin TABLET, CHEWABLE ORAL 19990825 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ASPIRIN 81 mg/1 0113-0271_ae8ffdae-90d5-4d05-b3c9-37f7f336ead6 0113-0271 HUMAN OTC DRUG Good Sense Acid Reducer Ranitidine TABLET ORAL 20090521 ANDA ANDA076760 L Perrigo Company RANITIDINE HYDROCHLORIDE 75 mg/1 0113-0272_c67f41d3-389a-483c-b184-298bf74658fc 0113-0272 HUMAN OTC DRUG Good Sense Sinus Congestion and Pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20061227 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 0113-0274_444b4ec9-2ce6-44d8-8371-0ea276a2cb8e 0113-0274 HUMAN OTC DRUG Good Sense aspirin Aspirin TABLET, CHEWABLE ORAL 19970808 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ASPIRIN 81 mg/1 0113-0277_2da738b8-ae3c-45e5-85fc-588f54154d57 0113-0277 HUMAN OTC DRUG good sense aspirin Aspirin TABLET, FILM COATED ORAL 19930709 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ASPIRIN 81 mg/1 0113-0279_379f8738-a871-4b09-abd1-c86386dfee04 0113-0279 HUMAN OTC DRUG Good Sense Hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140904 OTC MONOGRAPH FINAL part346 L. Perrigo Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 0113-0282_385b3e90-1f1c-40c5-9f0a-3948bf3f0d9c 0113-0282 HUMAN OTC DRUG Good Sense dayhist allergy Clemastine fumarate TABLET ORAL 19960711 ANDA ANDA074512 L Perrigo Company CLEMASTINE FUMARATE 1.34 mg/1 0113-0288_e0ca9979-4850-4ebd-be67-8883bb075cb6 0113-0288 HUMAN OTC DRUG Good Sense Mucus Relief Guaifenesin LIQUID ORAL 20071106 OTC MONOGRAPH FINAL part341 L Perrigo Company GUAIFENESIN 100 mg/5mL 0113-0289_e167efa2-ae41-4a9c-b58f-3143ba61ccc6 0113-0289 HUMAN OTC DRUG good sense pain relief infants concentrated Acetaminophen SUSPENSION/ DROPS ORAL 19931116 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ACETAMINOPHEN 80 mg/.8mL 0113-0291_d55dc546-ea99-4fc4-b50a-74c1c1a8287b 0113-0291 HUMAN OTC DRUG good sense anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 19940221 UNAPPROVED DRUG OTHER L Perrigo Company DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 0113-0294_db9c9efe-3012-43e2-86b6-a4c238d7fa25 0113-0294 HUMAN OTC DRUG good sense hair regrowth treatment Minoxidil AEROSOL, FOAM TOPICAL 20120301 ANDA ANDA091344 L. Perrigo Company MINOXIDIL 5 g/100g 0113-0296_8b6c8d1a-8b15-4d12-a6d0-3e98a80f291d 0113-0296 HUMAN OTC DRUG good sense tussin cf max dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20130111 OTC MONOGRAPH FINAL part341 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL 0113-0299_831a78b9-537d-42ed-afe3-fdf34eb856d3 0113-0299 HUMAN OTC DRUG good sense cold and flu severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20140317 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 0113-0302_613ce98c-9cbc-4f4a-9854-1e8e10de0e06 0113-0302 HUMAN OTC DRUG Good Sense Stomach Relief original strength Bismuth subsalicylate SUSPENSION ORAL 19890915 OTC MONOGRAPH FINAL part335 L. Perrigo Company BISMUTH SUBSALICYLATE 525 mg/30mL 0113-0304_3e34b952-2f99-4964-9769-cdb575b7ced2 0113-0304 HUMAN OTC DRUG Good Sense Nasal oxymetazoline hydrochloride SPRAY NASAL 19890915 OTC MONOGRAPH FINAL part341 L. Perrigo Company OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL 0113-0306_0e12cb95-ae16-4724-8137-e8e28e24a49a 0113-0306 HUMAN OTC DRUG Good Sense Clear Lax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 L. Perrigo Company POLYETHYLENE GLYCOL 3350 17 g/17g 0113-0308_d5fd1911-e247-498b-a4ca-702e50d66542 0113-0308 HUMAN OTC DRUG Good Sense cold multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20100927 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 0113-0310_3cf6891a-465a-4e47-950b-9d5357fc8cfa 0113-0310 HUMAN OTC DRUG good sense tussin chest congestion Guaifenesin SYRUP ORAL 19910115 OTC MONOGRAPH FINAL part341 L Perrigo Company GUAIFENESIN 100 mg/5mL 0113-0321_72cd0797-e844-4e82-a4ce-7944cd38fae8 0113-0321 HUMAN OTC DRUG Good Sense Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080805 ANDA ANDA077355 L Perrigo Company CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 0113-0323_b0648a57-69e0-4abc-8cf1-8e9b603ecebe 0113-0323 HUMAN OTC DRUG Good Sense Lubricating Plus carboxymethylcellulose sodium SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20131111 OTC MONOGRAPH FINAL part349 L. Perrigo Company CARBOXYMETHYLCELLULOSE SODIUM .5 g/100mL 0113-0328_76e79b97-f04f-40db-b466-faa32118b23f 0113-0328 HUMAN OTC DRUG Good Sense Sore Throat Phenol SPRAY ORAL 19930106 OTC MONOGRAPH NOT FINAL part356 L Perrigo Company PHENOL 1.4 g/100mL 0113-0332_98c5cb7f-a717-4a56-b4cc-840b71a086cc 0113-0332 HUMAN OTC DRUG good sense milk of magnesia stimulant free Magnesium hydroxide SUSPENSION ORAL 19910615 OTC MONOGRAPH NOT FINAL part334 L Perrigo Company MAGNESIUM HYDROXIDE 1200 mg/15mL 0113-0333_48e1633b-d2e4-49fe-bc50-ae246ec738bf 0113-0333 HUMAN OTC DRUG Good Sense enema mineral oil Mineral Oil LIQUID RECTAL 20091228 OTC MONOGRAPH NOT FINAL part334 L Perrigo Company MINERAL OIL 100 mL/100mL 0113-0335_ed8ab390-01ab-4c04-9fff-18b241336fb3 0113-0335 HUMAN OTC DRUG good sense night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110819 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 0113-0337_224fbb40-485d-4a87-919b-2e7b048668b8 0113-0337 HUMAN OTC DRUG Good Sense Stomach Relief bismuth subsalicylate LIQUID ORAL 19900115 OTC MONOGRAPH FINAL part335 L. Perrigo Company BISMUTH SUBSALICYLATE 1050 mg/30mL 0113-0340_5b845d2d-dec4-49ef-89ad-6dc6a064ceb6 0113-0340 HUMAN OTC DRUG good sense antacid aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 19900415 OTC MONOGRAPH FINAL part331 L Perrigo Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 0113-0344_be4b89bf-700c-463e-9479-9836fd229491 0113-0344 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex LOZENGE ORAL 20060725 ANDA ANDA077007 L. Perrigo Company NICOTINE 2 mg/1 0113-0345_0f251a73-ca3e-4390-b46f-57e7b483c701 0113-0345 HUMAN OTC DRUG Good Sense Severe Sinus Congestion Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140128 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 0113-0352_2bf35538-58f9-4d0b-ad1d-dd778765f2cc 0113-0352 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20130514 ANDA ANDA078547 L. Perrigo Company NICOTINE 2 mg/1 0113-0355_b776726d-e42f-4307-a6a9-d3b0d190fe18 0113-0355 HUMAN OTC DRUG Good Sense headache pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19960912 OTC MONOGRAPH FINAL part338 L Perrigo Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 0113-0357_859a7940-d98b-4f45-9008-8be6e87fdfea 0113-0357 HUMAN OTC DRUG Good Sense Antacid Regular Strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19900715 OTC MONOGRAPH FINAL part332 L. Perrigo Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 0113-0358_d4bcb524-2135-4eda-945e-d87fd42003c4 0113-0358 HUMAN OTC DRUG good sense sinus and allergy pe Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20061128 OTC MONOGRAPH FINAL part341 L Perrigo Company CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 0113-0359_74842118-0121-4a5c-b6cc-24a6653df53a 0113-0359 HUMAN OTC DRUG good sense tussin dm Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 19910918 OTC MONOGRAPH FINAL part341 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 0113-0368_426231be-c09f-494d-a8e0-b1654eaa5f65 0113-0368 HUMAN OTC DRUG Good Sense All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 19970114 ANDA ANDA074661 L. Perrigo Company NAPROXEN SODIUM 200 mg/1 0113-0371_3dce0b7a-1158-495f-b2c8-cff88955965a 0113-0371 HUMAN OTC DRUG Good Sense cold multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 19891015 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 0113-0374_b6864534-6687-4234-b345-41187b5e1f30 0113-0374 HUMAN OTC DRUG good sense migraine formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20020417 ANDA ANDA075794 L Perrigo Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0113-0377_3cb25c6f-fee6-461f-8f8f-56d9123faec3 0113-0377 HUMAN OTC DRUG Good Sense Anti Diarrheal Loperamide HCl SOLUTION ORAL 19920330 ANDA ANDA073243 L. Perrigo Company LOPERAMIDE HYDROCHLORIDE 1 mg/5mL 0113-0379_bf5039a0-2109-41a2-84a9-b5167d0a93da 0113-0379 HUMAN OTC DRUG good sense allergy Diphenhydramine HCl LIQUID ORAL 19890915 OTC MONOGRAPH FINAL part341 L Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 0113-0381_b62fe87f-eb6e-4017-a6f0-6c45bb72ee02 0113-0381 HUMAN OTC DRUG Good Sense Mucus Relief cold flu and sore throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130626 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 0113-0384_ecc09b2e-6e22-456b-8c30-73642f494fbe 0113-0384 HUMAN OTC DRUG good sense cough dm dextromethorphan polistirex SUSPENSION ORAL 20130201 ANDA ANDA091135 L Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 0113-0388_5d42adb9-3625-4072-a6b1-29a229f255c8 0113-0388 HUMAN OTC DRUG good sense nasal Oxymetazoline HCl SPRAY NASAL 20020513 OTC MONOGRAPH FINAL part341 L Perrigo Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 0113-0393_07ad3c6e-71be-4681-98f8-275d84599b8e 0113-0393 HUMAN OTC DRUG good sense cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070906 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 0113-0394_02f6064c-8030-4784-a975-de9722498f26 0113-0394 HUMAN OTC DRUG Good Sense hemorrhoidal Cocoa butter, Phenylephrine HCl, Shark liver oil SUPPOSITORY RECTAL 19980325 OTC MONOGRAPH FINAL part346 L Perrigo Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2137.5; 75; 6.375 mg/1; mg/1; mg/1 0113-0396_72b54b18-82d4-4969-8565-82963575fa85 0113-0396 HUMAN OTC DRUG Good Sense milk of magnesia stimulant free Magnesium hydroxide SUSPENSION ORAL 19910615 OTC MONOGRAPH NOT FINAL part334 L. Perrigo Company MAGNESIUM HYDROXIDE 1200 mg/15mL 0113-0397_b66add8a-c964-4c2f-8bb3-41e838d955d5 0113-0397 HUMAN OTC DRUG Good Sense Pain and Fever acetaminophen SUSPENSION ORAL 20120322 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ACETAMINOPHEN 160 mg/5mL 0113-0400_a7b35676-10e7-48db-8a4d-29f271471ad3 0113-0400 HUMAN OTC DRUG Good Sense Hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 19951220 OTC MONOGRAPH FINAL part346 L Perrigo Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 0113-0402_3cfb537f-6ff8-4d0e-afd1-f18821217f2a 0113-0402 HUMAN OTC DRUG Good Sense Cold Head Congestion Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 19920508 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 0113-0403_8b56bfc0-2253-458d-99a6-0b0f9ae0ba50 0113-0403 HUMAN OTC DRUG good sense pain relief Acetaminophen TABLET ORAL 19890815 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ACETAMINOPHEN 325 mg/1 0113-0404_5f70e468-be32-4c4f-891e-437bc38fe9fd 0113-0404 HUMAN OTC DRUG good sense allergy relief 4 hour Chlorpheniramine Maleate TABLET ORAL 19910729 OTC MONOGRAPH FINAL part341 L. Perrigo Company CHLORPHENIRAMINE MALEATE 4 mg/1 0113-0405_f8ef49de-5545-4aec-a32b-4d62310d91a7 0113-0405 HUMAN OTC DRUG good sense pain relief extra strength Acetaminophen TABLET ORAL 19890815 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ACETAMINOPHEN 500 mg/1 0113-0409_930f104d-fe3f-4081-be91-a19b56a9c43a 0113-0409 HUMAN OTC DRUG good sense stay awake Caffeine TABLET ORAL 19930323 OTC MONOGRAPH FINAL part340 L Perrigo Company CAFFEINE 200 mg/1 0113-0416_4e27246f-f8a9-408f-a57d-6eae3341562b 0113-0416 HUMAN OTC DRUG good sense aspirin Aspirin TABLET ORAL 19910415 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ASPIRIN 325 mg/1 0113-0419_b14b7b17-bf25-4a68-8953-8fac614e708f 0113-0419 HUMAN OTC DRUG Good Sense Childrens Mucus Relief Cough Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20071127 OTC MONOGRAPH FINAL part341 L Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 0113-0422_acfd3c21-a5ae-4ff2-8e24-2a107a4425de 0113-0422 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050422 ANDA ANDA078326 L Perrigo Company NICOTINE 4 mg/1 0113-0425_8604d951-cf44-41a0-a6ad-c66f4fde876c 0113-0425 HUMAN OTC DRUG Good Sense Aller Ease Fexofenadine HCl TABLET, FILM COATED ORAL 20110914 ANDA ANDA076447 L Perrigo Company FEXOFENADINE HYDROCHLORIDE 60 mg/1 0113-0428_6b2d8591-cc58-457e-92b6-c719eee85605 0113-0428 HUMAN OTC DRUG Good Sense Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 19990209 OTC MONOGRAPH FINAL part332 L Perrigo Company DIMETHICONE 125 mg/1 0113-0430_4f9ae045-cd88-4fdb-8375-5e222e60e0a1 0113-0430 HUMAN OTC DRUG Good Sense headache formula added strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19920120 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0113-0431_ba2adc30-0301-4d53-bce6-fc8b7e34b076 0113-0431 HUMAN OTC DRUG good sense nighttime sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20010425 OTC MONOGRAPH FINAL part338 L Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0113-0432_455b35b4-3969-411b-8036-887615d71e11 0113-0432 HUMAN OTC DRUG Good Sense Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 19890915 OTC MONOGRAPH FINAL part341 L Perrigo Company PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 0113-0437_8a68ccfb-dba9-431d-8839-7250369cb96a 0113-0437 HUMAN OTC DRUG good sense pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19920723 OTC MONOGRAPH FINAL part338 L Perrigo Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 0113-0441_438a81ec-0c5f-466f-8457-260d2776f044 0113-0441 HUMAN OTC DRUG Good sense sleep aid Doxylamine succinate TABLET ORAL 19970414 ANDA ANDA040167 L. Perrigo Company DOXYLAMINE SUCCINATE 25 mg/1 0113-0445_04f3ab0b-1a3c-4a9f-9519-ba296ccfd1f0 0113-0445 HUMAN OTC DRUG good sense flu and severe cold and cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20141030 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 0113-0456_4cf93e46-57e8-4179-b452-91e2ee52adb3 0113-0456 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070307 ANDA ANDA076777 L. Perrigo Company NICOTINE 2 mg/1 0113-0459_c159e362-5dae-4a22-ade1-82e94fa501a4 0113-0459 HUMAN OTC DRUG good sense nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110822 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 0113-0461_67e15204-4f36-434d-8b2d-4889d7608204 0113-0461 HUMAN OTC DRUG Good Sense ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20041109 ANDA ANDA076359 L Perrigo Company IBUPROFEN 100 mg/1 0113-0462_089cfa21-0614-40b9-be41-718a9c424f4d 0113-0462 HUMAN OTC DRUG Good Sense Allergy Relief diphenhydramine hydrochloride CAPSULE ORAL 19890915 OTC MONOGRAPH FINAL part341 L Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0113-0463_126385d1-d924-4d9c-9f99-766e27749749 0113-0463 HUMAN OTC DRUG good sense allergy Chlorpheniramine Maleate TABLET ORAL 19910729 OTC MONOGRAPH FINAL part341 L Perrigo Company CHLORPHENIRAMINE MALEATE 4 mg/1 0113-0467_23f4e2c8-2b36-4ad6-81a0-a8ce25e0912e 0113-0467 HUMAN OTC DRUG good sense aspirin Aspirin TABLET, CHEWABLE ORAL 19921104 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ASPIRIN 81 mg/1 0113-0468_56b3d9d6-afba-44d2-8333-164f6f344f01 0113-0468 HUMAN OTC DRUG good sense antacid Calcium carbonate TABLET, CHEWABLE ORAL 19970918 OTC MONOGRAPH FINAL part331 L Perrigo Company CALCIUM CARBONATE 750 mg/1 0113-0469_8b74e2db-3c9a-479f-9047-0082f500f220 0113-0469 HUMAN OTC DRUG good sense stomach relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 19930824 OTC MONOGRAPH FINAL part335 L Perrigo Company BISMUTH SUBSALICYLATE 262 mg/1 0113-0476_60f23b95-3e0c-49ba-aa9a-7bab2bc2b7cc 0113-0476 HUMAN OTC DRUG Good Sense Allergy Multi Symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20051006 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 0113-0477_82a7a50d-b6ce-435b-9de8-8f2d46887df9 0113-0477 HUMAN OTC DRUG Good Sense Fiber Laxative Calcium polycarbophil TABLET, FILM COATED ORAL 19970801 OTC MONOGRAPH NOT FINAL part334 L. Perrigo Company CALCIUM POLYCARBOPHIL 625 mg/1 0113-0478_8dcb1fbb-3a4e-4783-92b2-912cff5a5552 0113-0478 HUMAN OTC DRUG good sense antacid calcium carbonate TABLET, CHEWABLE ORAL 19891215 OTC MONOGRAPH FINAL part331 L Perrigo Company CALCIUM CARBONATE 500 mg/1 0113-0479_ef62e143-c2da-411f-8eef-4d239643ab58 0113-0479 HUMAN OTC DRUG good sense allergy relief Diphenhydramine Hydrochloride TABLET ORAL 19910820 OTC MONOGRAPH FINAL part341 L. Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0113-0484_e2c36776-8b15-43cc-bd81-89cb052704d9 0113-0484 HUMAN OTC DRUG Good Sense Pain Relief Acetaminophen TABLET ORAL 19890915 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 500 mg/1 0113-0485_4ab7bbff-6be5-4959-be0e-8c0ea1b487ab 0113-0485 HUMAN OTC DRUG good sense antacid calcium carbonate TABLET, CHEWABLE ORAL 19920617 OTC MONOGRAPH FINAL part331 L Perrigo Company CALCIUM CARBONATE 500 mg/1 0113-0486_4658d162-6e62-4d84-b5d6-7bf16c915558 0113-0486 HUMAN OTC DRUG good sense stool softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 19911029 OTC MONOGRAPH NOT FINAL part334 L Perrigo Company DOCUSATE SODIUM 100 mg/1 0113-0489_5f784a8b-2ee6-456b-9754-4f805caf4398 0113-0489 HUMAN OTC DRUG good sense antacid Calcium carbonate TABLET, CHEWABLE ORAL 20010228 OTC MONOGRAPH FINAL part331 L Perrigo Company CALCIUM CARBONATE 750 mg/1 0113-0498_7528d7ca-84c1-4a96-a06a-b96abc2338bb 0113-0498 HUMAN OTC DRUG Good Sense Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130321 ANDA ANDA078912 L. Perrigo Company GUAIFENESIN 600 mg/1 0113-0516_0ab3f68b-372f-4c9b-b1dc-f60d2f463fe8 0113-0516 HUMAN OTC DRUG good sense tussin cf cough and cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20060428 OTC MONOGRAPH FINAL part341 L Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 0113-0517_aebae4b3-18c8-4ecf-b578-1fe7cc50076b 0113-0517 HUMAN OTC DRUG Good Sense ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060427 ANDA ANDA077349 L Perrigo Company IBUPROFEN 200 mg/1 0113-0532_34296a3d-1ed4-4219-9ed6-8bd8bdfe43a9 0113-0532 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 19900715 ANDA ANDA076779 L. Perrigo Company NICOTINE 4 mg/1 0113-0535_aa46e805-d8f8-4db7-9466-113acae8ecfd 0113-0535 HUMAN OTC DRUG Good Sense Aspirin Enteric Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 19930930 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ASPIRIN 81 mg/1 0113-0541_754263f2-4513-464d-b6a6-b5cfd3c331f7 0113-0541 HUMAN OTC DRUG good sense anti itch Hydrocortisone CREAM TOPICAL 20060224 OTC MONOGRAPH NOT FINAL part348 L. Perrigo Company HYDROCORTISONE 1 g/100g 0113-0544_e98a634b-3854-4575-b634-06d6ed99c76a 0113-0544 HUMAN OTC DRUG good sense pain relief arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA075077 L Perrigo Company ACETAMINOPHEN 650 mg/1 0113-0546_1299479a-9016-4bc9-ac84-236fcc0a6282 0113-0546 HUMAN OTC DRUG good sense complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080805 ANDA ANDA077355 L Perrigo Company CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 0113-0548_63aac156-db78-470f-bf6f-47e357633634 0113-0548 HUMAN OTC DRUG Good Sense Severe Daytime Cold and Flu acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20131119 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 0113-0567_54d894ff-2db5-4a85-8477-53dffbcd5981 0113-0567 HUMAN OTC DRUG Good Sense NightTime DayTime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20140103 OTC MONOGRAPH FINAL part341 L. Perrigo Company 0113-0571_0a2f654a-b433-43c6-b62a-afa098eef385 0113-0571 HUMAN OTC DRUG good sense aller ease fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 L Perrigo Company FEXOFENADINE HYDROCHLORIDE 180 mg/1 0113-0578_3e6f0c8a-2b16-4f50-ad09-5377d6d46dde 0113-0578 HUMAN OTC DRUG good sense tussin dm cough and chest congestion Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19940920 OTC MONOGRAPH FINAL part341 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 0113-0579_4857ba0c-b04c-4e9b-bae6-11dd8cd9d220 0113-0579 HUMAN OTC DRUG good sense severe cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140523 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 0113-0588_dda69179-d981-4e5a-95c5-603e7a26e8d8 0113-0588 HUMAN OTC DRUG Good Sense Antacid Maximum Strength Aluminum Hydroxide, Magnesium Hydroxide, Simethicone LIQUID ORAL 20060213 OTC MONOGRAPH FINAL part332 L Perrigo Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 0113-0590_91daf80b-c8f4-41f9-be85-01710988a755 0113-0590 HUMAN OTC DRUG Good Sense Pain and Fever acetaminophen LIQUID ORAL 20111108 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ACETAMINOPHEN 160 mg/5mL 0113-0595_ceac317b-9068-46be-b598-bbac0aa39eb5 0113-0595 HUMAN OTC DRUG good sense antacid Calcium Carbonate TABLET, CHEWABLE ORAL 19950601 OTC MONOGRAPH FINAL part331 L Perrigo Company CALCIUM CARBONATE 1000 mg/1 0113-0603_d5faf89f-3641-4be1-8d43-35504f12fe8d 0113-0603 HUMAN OTC DRUG Good Sense Severe Daytime Cold and Flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20131119 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 0113-0604_0068711f-cb30-46c6-bc86-f4722a6df740 0113-0604 HUMAN OTC DRUG good sense ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19890915 ANDA ANDA072096 L Perrigo Company IBUPROFEN 200 mg/1 0113-0605_3bfdf3df-6453-4ff3-adb9-c4a260e28847 0113-0605 HUMAN OTC DRUG good sense miconazole 3 Miconazole nitrate KIT 20000225 ANDA ANDA075329 L Perrigo Company 0113-0608_ab96395c-a19e-40d6-b37e-7f988026fc95 0113-0608 HUMAN OTC DRUG good sense childrens pain and fever Acetaminophen SUSPENSION ORAL 19931008 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL 0113-0612_c5aa78b5-2e76-4781-aa3e-b2f6f7fa8f11 0113-0612 HUMAN OTC DRUG good sense allergy relief Loratadine TABLET ORAL 20040921 ANDA ANDA076301 L. Perrigo Company LORATADINE 10 mg/1 0113-0615_49e5068e-7c8c-4e44-a1bd-59abfb48320c 0113-0615 HUMAN OTC DRUG Good Sense itchy eye original prescription strength Ketotifen SOLUTION OPHTHALMIC 19971028 ANDA ANDA077958 L Perrigo Company KETOTIFEN FUMARATE .25 mg/mL 0113-0622_162fe0a3-3995-4e6f-94ed-f839b2b0c80e 0113-0622 HUMAN OTC DRUG good sense itch relief Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20060718 OTC MONOGRAPH NOT FINAL part348 L Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 0113-0645_2967950e-82f5-4d22-8270-bbfee5bf6cdb 0113-0645 HUMAN OTC DRUG good sense loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120131 ANDA ANDA091292 L Perrigo Company LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 0113-0647_88fa5888-ec2d-4162-8744-da57f3c3997b 0113-0647 HUMAN OTC DRUG good sense ibuprofen Ibuprofen TABLET, COATED ORAL 19910215 ANDA ANDA072096 L Perrigo Company IBUPROFEN 200 mg/1 0113-0648_930469c1-384c-4440-b3e6-9dcd674871c4 0113-0648 HUMAN OTC DRUG Good Sense Nasal Four Phenylephrine hydrochloride SPRAY NASAL 20020809 OTC MONOGRAPH FINAL part341 L Perrigo Company PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 0113-0656_0998b59f-daa1-47f9-8a7f-2b75c50d7892 0113-0656 HUMAN OTC DRUG Good Sense Daytime non drowsy cold and flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20060725 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 0113-0657_14caaf5a-6877-40f9-af8f-fb48de94ecfe 0113-0657 HUMAN OTC DRUG good sense gas relief Simethicone CAPSULE, LIQUID FILLED ORAL 20020405 OTC MONOGRAPH FINAL part332 L Perrigo Company DIMETHICONE 180 mg/1 0113-0660_39aa6fd4-fe98-4285-9f10-133c6dfe7c16 0113-0660 HUMAN OTC DRUG Good Sense Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20020409 ANDA ANDA074937 L. Perrigo Company IBUPROFEN 100 mg/5mL 0113-0666_04c0fed5-bce6-4f02-9955-95f7071676e2 0113-0666 HUMAN OTC DRUG good sense cough and sore throat night time Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20060914 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 0113-0668_96bf3b30-38d8-46b6-a335-33d976b62b8e 0113-0668 HUMAN OTC DRUG Good Sense Nighttime Cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20021103 OTC MONOGRAPH FINAL part341 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 0113-0678_1776cee6-fa3d-47e3-b566-c52de6473ab7 0113-0678 HUMAN OTC DRUG good sense hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20121026 OTC MONOGRAPH FINAL part346 L Perrigo Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 0113-0679_8f6409d2-de70-4f23-b3bc-2a0fdbef5fc4 0113-0679 HUMAN OTC DRUG Good Sense Triple Antibiotic and Pain Relief Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20060214 OTC MONOGRAPH FINAL part333B L. Perrigo Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 0113-0685_8a7430d5-248a-4372-bfdf-c6b4f4cc38f2 0113-0685 HUMAN OTC DRUG Good Sense Ibuprofen Ibuprofen LIQUID ORAL 19940509 ANDA ANDA074937 L Perrigo Company IBUPROFEN 100 mg/5mL 0113-0692_2fc42e96-4827-4a46-84fe-337391d87457 0113-0692 HUMAN OTC DRUG good sense cool heat Menthol, Methyl salicylate CREAM TOPICAL 20140415 OTC MONOGRAPH NOT FINAL part348 L. Perrigo Company MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g 0113-0695_6f8aa0fe-5e91-4598-8f30-999824a03a1e 0113-0695 HUMAN OTC DRUG good sense jock itch Tolnaftate SPRAY TOPICAL 20050615 OTC MONOGRAPH FINAL part333C L Perrigo Company TOLNAFTATE 1 g/100g 0113-0698_c624dadd-04b6-4dc2-aea4-37c387805288 0113-0698 HUMAN OTC DRUG good sense cough and sore throat daytime non drowsy Acetaminophen, Dextromethorphan HBr LIQUID ORAL 20070219 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 500; 15 mg/15mL; mg/15mL 0113-0703_a2a23874-efdc-4cad-b82b-9d7a08468c19 0113-0703 HUMAN OTC DRUG Good Sense Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20140729 OTC MONOGRAPH FINAL part341 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 0113-0734_46af1b81-9c39-46e4-be59-c6c084421d97 0113-0734 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex LOZENGE ORAL 20130422 ANDA ANDA203690 L. Perrigo Company NICOTINE 2 mg/1 0113-0742_c7667624-90e0-48dc-8425-5f156a8aec3d 0113-0742 HUMAN OTC DRUG Good Sense Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20101202 NDA NDA021920 L. Perrigo Company NAPROXEN SODIUM 220 mg/1 0113-0751_e99ba6a6-d2ba-4c61-892f-a8cfb23d04be 0113-0751 HUMAN OTC DRUG good sense pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120125 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 0113-0759_b3cc17d5-a413-4b42-99ed-c7c27d333b6e 0113-0759 HUMAN OTC DRUG good sense pain relief Acetaminophen SUSPENSION ORAL 20100729 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ACETAMINOPHEN 160 mg/5mL 0113-0763_f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2 0113-0763 HUMAN OTC DRUG Good Sense Severe NightTime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl LIQUID ORAL 20131119 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 0113-0798_967f700f-094b-4069-9331-6c2425f34e6c 0113-0798 HUMAN OTC DRUG Good Sense Hair Regrowth Treatment for Men Minoxidil SOLUTION TOPICAL 20100210 ANDA ANDA075598 L. Perrigo Company MINOXIDIL 3 g/60mL 0113-0799_40b1e631-79d6-45f4-8515-5835750f3e77 0113-0799 HUMAN OTC DRUG Good Sense tussin dm max Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20100415 OTC MONOGRAPH FINAL part341 L Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 0113-0807_4eac4d1d-6f01-409c-b91b-d463f6b3d49d 0113-0807 HUMAN OTC DRUG good sense cold remedy non drowsy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 19920729 UNAPPROVED HOMEOPATHIC L Perrigo Company ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 0113-0817_01e85881-3ec0-4854-ab65-1fad2f12993e 0113-0817 HUMAN OTC DRUG Good Sense Nasal oxymetazoline hydrochloride SPRAY NASAL 19960418 OTC MONOGRAPH FINAL part341 L. Perrigo Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 0113-0818_cb35de63-84bb-47c6-8d62-a10412eb4e42 0113-0818 HUMAN OTC DRUG good sense day time Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20101028 OTC MONOGRAPH FINAL part341 L Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/15mL; mg/15mL 0113-0825_090ee644-7f73-4a43-aa5e-bfa74b0d5130 0113-0825 HUMAN OTC DRUG good sense miconazole 7 Miconazole nitrate CREAM VAGINAL 20000222 ANDA ANDA074760 L Perrigo Company MICONAZOLE NITRATE 2 g/100g 0113-0829_7c480605-b2c6-48fc-b526-3f3546219c52 0113-0829 HUMAN OTC DRUG Good Sense pain relief pm extra strength Acetaminophen, Diphenhydramine HCl CAPSULE, COATED ORAL 19910615 OTC MONOGRAPH FINAL part338 L Perrigo Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 0113-0837_2633ff8c-0f03-4ec6-beaa-e5c5163b8995 0113-0837 HUMAN OTC DRUG Good Sense Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 19980126 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 0113-0839_afe30126-9879-4bad-aee9-ee21b3fb0444 0113-0839 HUMAN OTC DRUG Good Sense Childrens Mucus Relief dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20140325 OTC MONOGRAPH FINAL part341 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 0113-0851_d6356937-2ada-4f82-8243-f1dc7a43c56f 0113-0851 HUMAN OTC DRUG good sense antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20030204 OTC MONOGRAPH FINAL part332 L Perrigo Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 0113-0852_425129ef-72c7-44dd-b7ce-4b8bec2bf982 0113-0852 HUMAN OTC DRUG Good Sense Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20080219 ANDA ANDA091429 L. Perrigo Company RANITIDINE HYDROCHLORIDE 150 mg/1 0113-0854_7ec2f562-c5f6-4b2b-a6ad-0830b61d6160 0113-0854 HUMAN OTC DRUG Good Sense Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20130514 ANDA ANDA078546 L. Perrigo Company NICOTINE 4 mg/1 0113-0856_1a6bb0a8-a729-4c8e-9451-e60732e37a24 0113-0856 HUMAN OTC DRUG Good Sense hair regrowth treatment for women Minoxidil SOLUTION TOPICAL 20100211 ANDA ANDA075357 L Perrigo Company MINOXIDIL 2 g/100mL 0113-0857_4ec05b38-d8d6-48b5-89fd-d588de0e428a 0113-0857 HUMAN OTC DRUG Good Sense Athletes Foot antifungal Clotrimazole CREAM TOPICAL 20060409 OTC MONOGRAPH FINAL part333 L Perrigo Company CLOTRIMAZOLE 1 g/100g 0113-0866_560ed35e-1d86-40f8-aae4-b9f902ca8873 0113-0866 HUMAN OTC DRUG good sense lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20071208 OTC MONOGRAPH FINAL part358G L Perrigo Company PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 0113-0872_61bd9558-0e4c-4892-ae24-c4fe38f68b5a 0113-0872 HUMAN OTC DRUG Good Sense Night Time Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20130104 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 0113-0873_a09191ce-afff-4001-8e4f-fcf7e5f57798 0113-0873 HUMAN OTC DRUG good sense nicotine Nicotine Polacrilex LOZENGE ORAL 20061227 ANDA ANDA077007 L. Perrigo Company NICOTINE 4 mg/1 0113-0881_9fe9e76e-dc62-499b-9258-fac4dc75be4c 0113-0881 HUMAN OTC DRUG Good Sense Antacid calcium carbonate TABLET, CHEWABLE ORAL 20140923 OTC MONOGRAPH FINAL part331 L. Perrigo Company CALCIUM CARBONATE 1000 mg/1 0113-0882_facbdec7-eb5e-42dc-8ca3-02a426425797 0113-0882 HUMAN OTC DRUG good sense simethicone infants Simethicone EMULSION ORAL 20000223 OTC MONOGRAPH FINAL part332 L Perrigo Company DIMETHICONE 20 mg/.3mL 0113-0884_1a574075-f415-4a6d-8040-1c9d10e3854e 0113-0884 HUMAN OTC DRUG good sense childrens all day allergy cetirizine Hydrochloride LIQUID ORAL 19920615 ANDA ANDA090254 L Perrigo Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 0113-0896_d0924efb-4849-4172-887d-55ca7547de14 0113-0896 HUMAN OTC DRUG Good Sense Lubricant Eye Polyethylene glycol, Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20140218 OTC MONOGRAPH FINAL part349 L. Perrigo Company POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 g/100mL; g/100mL 0113-0897_c4eb25d3-bfd9-4640-83d5-fe0750a21fd4 0113-0897 HUMAN OTC DRUG good sense ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990107 ANDA ANDA074937 L. Perrigo Company IBUPROFEN 100 mg/5mL 0113-0901_29400f56-dd35-4481-ae78-070369252264 0113-0901 HUMAN OTC DRUG Good Sense Naproxen Sodium Naproxen Sodium TABLET ORAL 20140423 ANDA ANDA074661 L. Perrigo Company NAPROXEN SODIUM 220 mg/1 0113-0903_b03f1587-aa21-4417-b634-147086a1886f 0113-0903 HUMAN OTC DRUG good sense cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20101222 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 0113-0904_dbf5d3ee-f467-4ef0-a469-478e8ba52457 0113-0904 HUMAN OTC DRUG good sense antacid Calcium carbonate TABLET, CHEWABLE ORAL 20140923 OTC MONOGRAPH FINAL part331 L. Perrigo Company CALCIUM CARBONATE 1000 mg/1 0113-0906_885b0f5a-4a1f-4786-a5d5-2ca5f7a013a6 0113-0906 HUMAN OTC DRUG good sense childrens cold and allergy phenylephrine hcl, brompheniramine maleate ELIXIR ORAL 20070224 OTC MONOGRAPH FINAL part341 L. Perrigo Company BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 0113-0908_5c63015c-aaaa-4c25-88b9-b3af57121fc5 0113-0908 HUMAN OTC DRUG Good Sense Night Time Cold and Flu acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20060327 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 0113-0911_8aa0f0fe-4393-41b1-bdf9-7148c53db381 0113-0911 HUMAN OTC DRUG good sense childrens ibuprofen oral suspension Ibuprofen SUSPENSION ORAL 20020409 ANDA ANDA074937 L Perrigo Company IBUPROFEN 100 mg/5mL 0113-0915_6ad641e2-e71b-499a-b987-57028d312333 0113-0915 HUMAN OTC DRUG Good Sense Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080228 NDA NDA022032 L. Perrigo Company OMEPRAZOLE 20 mg/1 0113-0916_e303ce9d-ddd2-4abe-bf04-0f6ac87a506b 0113-0916 HUMAN OTC DRUG good sense miconazole 1 Miconazole nitrate KIT 20100629 ANDA ANDA079114 L. Perrigo Company 0113-0917_6b755115-7343-4e65-8fa3-d5c097b8e4a6 0113-0917 HUMAN OTC DRUG good sense pain relief Acetaminophen CAPSULE, COATED ORAL 20110216 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 500 mg/1 0113-0922_4dd7355c-d62b-41eb-885b-4cbea3cfa403 0113-0922 HUMAN OTC DRUG Good Sense Mucus Relief Severe Congestion and Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130626 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 0113-0923_4a5ff1bc-3bb5-4f69-bd7f-0374a8d8468b 0113-0923 HUMAN OTC DRUG good sense eye itch relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20100915 ANDA ANDA077958 L Perrigo Company KETOTIFEN FUMARATE .25 mg/mL 0113-0934_f762ee6b-9cf5-4533-9aab-154d8d13924c 0113-0934 HUMAN OTC DRUG Good Sense Adult Tussin DM dextromethorphan hbr, guaifenesin SUSPENSION ORAL 20130920 OTC MONOGRAPH FINAL part341 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 0113-0944_a402f156-f36c-4c06-b245-d9de266d2cc9 0113-0944 HUMAN OTC DRUG Good Sense Hemorrhoidal Maximum Strength Pain Relief glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20080228 OTC MONOGRAPH FINAL part346 L. Perrigo Company GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g 0113-0946_ed38112f-200e-49cd-80b3-4383f1090641 0113-0946 HUMAN OTC DRUG good sense pain and fever infants Acetaminophen SUSPENSION ORAL 20111108 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ACETAMINOPHEN 160 mg/5mL 0113-0949_61cf955a-b14c-4319-8c47-cdfda0c25c1c 0113-0949 HUMAN OTC DRUG Good Sense Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 20050711 OTC MONOGRAPH NOT FINAL part334 L. Perrigo Company MAGNESIUM HYDROXIDE 1200 mg/15mL 0113-0950_6bbb38d6-2dc1-4a04-a2c4-ab1139a31770 0113-0950 HUMAN OTC DRUG good sense acid reducer Ranitidine TABLET, FILM COATED ORAL 20111021 ANDA ANDA091429 L Perrigo Company RANITIDINE HYDROCHLORIDE 150 mg/1 0113-0955_c62f5903-b714-46c5-83a7-d87bae4d8af3 0113-0955 HUMAN OTC DRUG good sense lice treatment Permethrin LOTION TOPICAL 20111123 ANDA ANDA076090 L Perrigo Company PERMETHRIN 1 mg/100mL 0113-0957_685be4c5-41a0-4d48-a558-d6e574f59cf1 0113-0957 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex LOZENGE ORAL 20130427 ANDA ANDA203690 L. Perrigo Company NICOTINE 4 mg/1 0113-0958_5a2e9bef-42cb-4b72-9a26-c3ae71dcb4ea 0113-0958 HUMAN OTC DRUG Good Sense Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130620 ANDA ANDA091135 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 0113-0962_2ea98f53-4fb5-4a1d-8f20-ee3e7b55f424 0113-0962 HUMAN OTC DRUG good sense antacid Calcium carbonate TABLET, CHEWABLE ORAL 20140923 OTC MONOGRAPH FINAL part331 L. Perrigo Company CALCIUM CARBONATE 1000 mg/1 0113-0964_b1b3153a-5283-4dcc-bb44-eeb79c1a484c 0113-0964 HUMAN OTC DRUG good sense flu and severe cold and cough nighttime Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20100917 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 0113-0973_9d86f709-e5db-49e5-85c6-09f4d666ece3 0113-0973 HUMAN OTC DRUG Good Sense Anti Itch hydrocortisone CREAM TOPICAL 20060307 OTC MONOGRAPH NOT FINAL part348 L Perrigo Company HYDROCORTISONE 1 g/100g 0113-0974_8bf39f7d-fee7-4457-b475-630932b34e42 0113-0974 HUMAN OTC DRUG good sense childrens all day allergy cetirizine hydrochloride LIQUID ORAL 20080418 ANDA ANDA090254 L Perrigo Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 0113-0977_686b4ff4-a7c1-4f01-9d40-2b3d095c2036 0113-0977 HUMAN OTC DRUG Good Sense night time cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20060517 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 0113-0987_8a87104f-94a4-4585-afd5-d610eea32e39 0113-0987 HUMAN OTC DRUG Good Sense Childrens Cold and Cough Elixir Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20070224 OTC MONOGRAPH FINAL part343 L Perrigo Company BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 0113-0990_5467e18c-e154-4f03-b75e-33038528c1a7 0113-0990 HUMAN OTC DRUG good sense night time acetaminophen, dextromethorphan hydrobromide, doxylamine succinate LIQUID ORAL 20101014 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 0113-0994_a9911244-32eb-420d-97bb-d24951d20713 0113-0994 HUMAN OTC DRUG good sense daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20070118 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 0113-0998_7111f326-8350-4039-ab7f-6b4bc39e73ad 0113-0998 HUMAN OTC DRUG Good Sense Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20100729 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL 0113-1165_11bc7e68-0956-4e74-b182-e3a63cd3b96e 0113-1165 HUMAN OTC DRUG good sense allergy and congestion relief non drowsy 24 hour Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20030624 ANDA ANDA075706 L Perrigo Company LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 0113-1411_ffa679f4-04d2-4aac-84df-2b99d08ca25d 0113-1411 HUMAN OTC DRUG smart health aspirin regular strength Aspirin TABLET ORAL 20030409 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ASPIRIN 325 mg/1 0113-2013_61954e87-ff18-4dff-8cb5-a1e665989745 0113-2013 HUMAN OTC DRUG Allergy and Congestion Relief Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120123 ANDA ANDA076050 L. Perrigo Company LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 0113-2054_2830cbbc-7309-4dc3-8622-62497e867fe8 0113-2054 HUMAN OTC DRUG 12 hour decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111004 ANDA ANDA075153 L Perrigo Company PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 0113-2061_bc896906-039e-4da5-842d-af1d3854a878 0113-2061 HUMAN OTC DRUG tussin mucus plus chest congestion Guaifenesin SYRUP ORAL 19870715 OTC MONOGRAPH FINAL part341 L Perrigo Company GUAIFENESIN 200 mg/10mL 0113-2141_508478f6-230e-40a0-93f5-428b18cc70ad 0113-2141 HUMAN OTC DRUG Acid Reducer Famotidine TABLET ORAL 20140723 ANDA ANDA075400 L. Perrigo Company FAMOTIDINE 10 mg/1 0113-2176_e3133af3-d804-4f96-8dda-8471927e6565 0113-2176 HUMAN OTC DRUG All Day Allergy-D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20110906 ANDA ANDA077170 L. Perrigo Company CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 0113-2304_209a0f3c-0f69-4fd0-b3be-4389fd3fda23 0113-2304 HUMAN OTC DRUG Nasal oxymetazoline hydrochloride SPRAY NASAL 19910729 OTC MONOGRAPH FINAL part341 L. Perrigo Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 0113-2310_08a68341-cbd0-483c-96f1-f470781b4304 0113-2310 HUMAN OTC DRUG Tussin Guaifenesin SYRUP ORAL 19870715 OTC MONOGRAPH FINAL part341 L Perrigo Company GUAIFENESIN 100 mg/5mL 0113-2365_87ba26c1-f94d-435c-accc-4961a094879d 0113-2365 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20121129 ANDA ANDA091349 L. Perrigo Company NICOTINE 2 mg/1 0113-2432_df7f68f3-be80-4262-849a-dc4be160b1ef 0113-2432 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 19870715 OTC MONOGRAPH FINAL part341 L Perrigo Company PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 0113-2442_3e13c949-8e79-48e6-9f81-a2780659c4d7 0113-2442 HUMAN OTC DRUG Nicotine Polacrilex Nicotine polacrilex GUM, CHEWING ORAL 20121217 ANDA ANDA091354 L. Perrigo Company NICOTINE 4 mg/1 0113-2476_ba0f265b-73a0-46ef-ba59-fc3405091faa 0113-2476 HUMAN OTC DRUG Allergy Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20140320 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 0113-4368_9ca88d57-2efc-47c0-a79b-69b2553fb2cd 0113-4368 HUMAN OTC DRUG Good Sense Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20140331 ANDA ANDA074661 L. Perrigo Company NAPROXEN SODIUM 220 mg/1 0113-8365_24f0fad2-a60e-435f-a006-a378ca8dedca 0113-8365 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20120119 ANDA ANDA091349 L. Perrigo Company NICOTINE 2 mg/1 0113-8442_84af705a-9d43-4153-8b85-fb3d4672cf38 0113-8442 HUMAN OTC DRUG Nicotine Stop Smoking Aid Nicotine polacrilex GUM, CHEWING ORAL 20120119 ANDA ANDA091354 L. Perrigo Company NICOTINE 4 mg/1 0113-8959_c898a472-9b38-4a80-8df7-f703dca7889f 0113-8959 HUMAN OTC DRUG Good Sense Pain and Fever Acetaminophen SUSPENSION ORAL 20120322 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL 0113-9458_b42bc89c-c2f4-44db-9fd6-fa4bda94bb6c 0113-9458 HUMAN OTC DRUG Good Sense all day allergy Cetirizine Hydrochloride TABLET ORAL 20080116 ANDA ANDA078336 L Perrigo Company CETIRIZINE HYDROCHLORIDE 10 mg/1 0113-9490_e1c69c9b-1da3-462d-bf78-5f16519c9f95 0113-9490 HUMAN OTC DRUG good sense all day pain relief Naproxen Sodium TABLET ORAL 19970114 ANDA ANDA074661 L Perrigo Company NAPROXEN SODIUM 220 mg/1 0115-0511_f90f7ee9-fc66-45fc-8304-4744c8a3ee87 0115-0511 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 Global Pharmaceuticals, Division of Impax Laboratories Inc. FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0115-0522_f90f7ee9-fc66-45fc-8304-4744c8a3ee87 0115-0522 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 Global Pharmaceuticals, Division of Impax Laboratories Inc. FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0115-0533_f90f7ee9-fc66-45fc-8304-4744c8a3ee87 0115-0533 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 Global Pharmaceuticals, Division of Impax Laboratories Inc. FENOFIBRATE 200 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0115-0671_350eb39e-6072-4467-8f57-ed6edcdbccd8 0115-0671 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET ORAL 20130514 NDA NDA020768 Global Pharmaceuticals, Division of Impax Laboratories Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0115-0672_350eb39e-6072-4467-8f57-ed6edcdbccd8 0115-0672 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET ORAL 20130514 NDA NDA020768 Global Pharmaceuticals, Division of Impax Laboratories Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0115-0691_350eb39e-6072-4467-8f57-ed6edcdbccd8 0115-0691 HUMAN PRESCRIPTION DRUG Zolmitriptan Orally Disintegrating Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130514 NDA NDA021231 Global Pharmaceuticals, Division of Impax Laboratories Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0115-0692_350eb39e-6072-4467-8f57-ed6edcdbccd8 0115-0692 HUMAN PRESCRIPTION DRUG Zolmitriptan Orally Disintegrating Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130514 NDA NDA021231 Global Pharmaceuticals, Division of Impax Laboratories Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0115-1030_4bb9956a-d98d-42b4-9aff-ab8b0cc24ca1 0115-1030 HUMAN PRESCRIPTION DRUG Primidone PRIMIDONE TABLET ORAL 20080212 ANDA ANDA040717 Global Pharmaceuticals PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0115-1031_4bb9956a-d98d-42b4-9aff-ab8b0cc24ca1 0115-1031 HUMAN PRESCRIPTION DRUG Primidone PRIMIDONE TABLET ORAL 20080212 ANDA ANDA040717 Global Pharmaceuticals PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0115-1040_2536d04e-08b7-4eee-82fa-c9706b55afdb 0115-1040 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20080212 ANDA ANDA040724 Global Pharmaceuticals, Division of Impax Laboratories Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0115-1041_2536d04e-08b7-4eee-82fa-c9706b55afdb 0115-1041 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20080212 ANDA ANDA040724 Global Pharmaceuticals, Division of Impax Laboratories Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0115-1042_2536d04e-08b7-4eee-82fa-c9706b55afdb 0115-1042 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20080520 ANDA ANDA040791 Global Pharmaceuticals, Division of Impax Laboratories Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0115-1070_691ffcf1-b797-48cd-8966-8bba63f3d97e 0115-1070 HUMAN PRESCRIPTION DRUG Dipyridamole DIPYRIDAMOLE TABLET ORAL 20070718 ANDA ANDA040782 Global Pharmaceuticals, Division of Impax Laboratories Inc. DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0115-1071_691ffcf1-b797-48cd-8966-8bba63f3d97e 0115-1071 HUMAN PRESCRIPTION DRUG Dipyridamole DIPYRIDAMOLE TABLET ORAL 20070718 ANDA ANDA040782 Global Pharmaceuticals, Division of Impax Laboratories Inc. DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0115-1072_691ffcf1-b797-48cd-8966-8bba63f3d97e 0115-1072 HUMAN PRESCRIPTION DRUG Dipyridamole DIPYRIDAMOLE TABLET ORAL 20070718 ANDA ANDA040782 Global Pharmaceuticals, Division of Impax Laboratories Inc. DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0115-1120_2bec3ab0-31c5-48d6-b435-f04d1281665b 0115-1120 HUMAN PRESCRIPTION DRUG GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE ORAL 20090527 ANDA ANDA078484 Global Pharmaceuticals, Division of Impax Laboratories Inc. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0115-1121_2bec3ab0-31c5-48d6-b435-f04d1281665b 0115-1121 HUMAN PRESCRIPTION DRUG GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE ORAL 20090527 ANDA ANDA078484 Global Pharmaceuticals, Division of Impax Laboratories Inc. GALANTAMINE HYDROBROMIDE 16 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0115-1122_2bec3ab0-31c5-48d6-b435-f04d1281665b 0115-1122 HUMAN PRESCRIPTION DRUG GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE ORAL 20090527 ANDA ANDA078484 Global Pharmaceuticals, Division of Impax Laboratories Inc. GALANTAMINE HYDROBROMIDE 24 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0115-1150_b4b8d18e-bfd3-4c8b-b941-bdc988b07259 0115-1150 HUMAN PRESCRIPTION DRUG Acarbose ACARBOSE TABLET ORAL 20090514 ANDA ANDA078441 Global Pharmaceuticals, Division of Impax Laboratories, Inc. ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 0115-1151_b4b8d18e-bfd3-4c8b-b941-bdc988b07259 0115-1151 HUMAN PRESCRIPTION DRUG Acarbose ACARBOSE TABLET ORAL 20090514 ANDA ANDA078441 Global Pharmaceuticals, Division of Impax Laboratories, Inc. ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 0115-1152_b4b8d18e-bfd3-4c8b-b941-bdc988b07259 0115-1152 HUMAN PRESCRIPTION DRUG Acarbose ACARBOSE TABLET ORAL 20090514 ANDA ANDA078441 Global Pharmaceuticals, Division of Impax Laboratories, Inc. ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 0115-1205_fcd628a2-170c-495d-8668-c4139a357b1e 0115-1205 HUMAN PRESCRIPTION DRUG Benzphetamine Hydrochloride Benzphetamine Hydrochloride TABLET ORAL 20081201 ANDA ANDA040845 Global Pharmaceuticals, Division of Impax Laboratories Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] 0115-1208_b7681b12-ddc1-469c-8c7e-c35d689fff6a 0115-1208 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE ORAL 20110411 ANDA ANDA090505 Global Pharmaceuticals, Division of Impax Laboratories, Inc. DOXYCYCLINE HYCLATE 75 mg/1 0115-1209_b7681b12-ddc1-469c-8c7e-c35d689fff6a 0115-1209 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE ORAL 20110411 ANDA ANDA090505 Global Pharmaceuticals, Division of Impax Laboratories, Inc. DOXYCYCLINE HYCLATE 100 mg/1 0115-1231_03344d7d-2e01-4e79-b7a4-4f1f3315278f 0115-1231 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Global Pharmaceuticals, Division of Impax Laboratories, Inc. OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0115-1232_03344d7d-2e01-4e79-b7a4-4f1f3315278f 0115-1232 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Global Pharmaceuticals, Division of Impax Laboratories, Inc. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0115-1233_03344d7d-2e01-4e79-b7a4-4f1f3315278f 0115-1233 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Global Pharmaceuticals, Division of Impax Laboratories, Inc. OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0115-1234_03344d7d-2e01-4e79-b7a4-4f1f3315278f 0115-1234 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Global Pharmaceuticals, Division of Impax Laboratories, Inc. OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0115-1245_e439cf09-76f3-454b-b7ea-852ecd45941b 0115-1245 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090203 ANDA ANDA090024 Global Pharmaceuticals, Division of Impax Laboratories Inc. MINOCYCLINE HYDROCHLORIDE 45 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0115-1246_e439cf09-76f3-454b-b7ea-852ecd45941b 0115-1246 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090203 ANDA ANDA090024 Global Pharmaceuticals, Division of Impax Laboratories Inc. MINOCYCLINE HYDROCHLORIDE 90 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0115-1247_e439cf09-76f3-454b-b7ea-852ecd45941b 0115-1247 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090203 ANDA ANDA090024 Global Pharmaceuticals, Division of Impax Laboratories Inc. MINOCYCLINE HYDROCHLORIDE 135 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0115-1315_03344d7d-2e01-4e79-b7a4-4f1f3315278f 0115-1315 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Global Pharmaceuticals, Division of Impax Laboratories, Inc. OXYMORPHONE HYDROCHLORIDE 7.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0115-1316_03344d7d-2e01-4e79-b7a4-4f1f3315278f 0115-1316 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Global Pharmaceuticals, Division of Impax Laboratories, Inc. OXYMORPHONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0115-1317_03344d7d-2e01-4e79-b7a4-4f1f3315278f 0115-1317 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Global Pharmaceuticals, Division of Impax Laboratories, Inc. OXYMORPHONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0115-1327_41cdae9b-94ad-47f2-9af0-6e9d4f077cd1 0115-1327 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20110217 ANDA ANDA200065 Global Pharmaceuticals, Division of Impax Laboratories Inc. DOXYCYCLINE 150 mg/1 0115-1328_4ddb197e-1ade-40e4-9da2-a5da697e6d88 0115-1328 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20131217 NDA AUTHORIZED GENERIC NDA021303 Global Pharmaceuticals, Division of Impax Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0115-1329_4ddb197e-1ade-40e4-9da2-a5da697e6d88 0115-1329 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20131217 NDA AUTHORIZED GENERIC NDA021303 Global Pharmaceuticals, Division of Impax Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0115-1330_4ddb197e-1ade-40e4-9da2-a5da697e6d88 0115-1330 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20131217 NDA AUTHORIZED GENERIC NDA021303 Global Pharmaceuticals, Division of Impax Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0115-1331_4ddb197e-1ade-40e4-9da2-a5da697e6d88 0115-1331 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20131217 NDA AUTHORIZED GENERIC NDA021303 Global Pharmaceuticals, Division of Impax Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0115-1332_4ddb197e-1ade-40e4-9da2-a5da697e6d88 0115-1332 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20131217 NDA AUTHORIZED GENERIC NDA021303 Global Pharmaceuticals, Division of Impax Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0115-1333_4ddb197e-1ade-40e4-9da2-a5da697e6d88 0115-1333 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20131217 NDA AUTHORIZED GENERIC NDA021303 Global Pharmaceuticals, Division of Impax Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0115-1459_c7a3b53e-9c23-799a-829e-23be8162396d 0115-1459 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20081215 NDA NDA022224 Global Pharmaceuticals, Division of Impax Laboratories Inc. FENOFIBRIC ACID 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 0115-1460_c7a3b53e-9c23-799a-829e-23be8162396d 0115-1460 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20081215 NDA NDA022224 Global Pharmaceuticals, Division of Impax Laboratories Inc. FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 0115-1468_a3873b70-6319-4e2f-8c0b-5f07ecb6445f 0115-1468 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine Lidocaine and Prilocaine CREAM TOPICAL 20030827 ANDA ANDA076320 Global Pharmaceuticals, Division of Impax Laboratories Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0115-1469_250ca78a-7cff-4e25-bc27-84a6d3496e94 0115-1469 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20031114 ANDA ANDA076481 Global Pharmaceuricals, Division of IMPAX Laboratories, Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0115-1470_a7e3350d-983e-4d13-9c85-223cef3096bb 0115-1470 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20070418 ANDA ANDA076591 Global Pharmaceuricals, Division of IMPAX Laboratories, Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0115-1471_1825edfc-c780-47fe-8569-6ca27776b283 0115-1471 HUMAN PRESCRIPTION DRUG Mometasone furoate Mometasone Furoate LOTION TOPICAL 20071121 ANDA ANDA076499 Global Pharmaceutials, Division of IMPAX Laboratories, Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0115-1472_165d0921-cce2-491a-9562-fb54483638f4 0115-1472 HUMAN PRESCRIPTION DRUG Betamethasone Betamethasone CREAM TOPICAL 20040123 ANDA ANDA076603 Global Pharmaceuticals, Division of Impax Laboratories Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0115-1473_21d04b65-c8f4-43da-b8db-f95602da5a5b 0115-1473 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate CREAM TOPICAL 20040514 ANDA ANDA076633 Global Pharmaceuticals, Division of IMPAX Laboratories Inc. FLUTICASONE PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0115-1474_29e089a5-f1b3-4618-90f4-a96a0a2a799c 0115-1474 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL TOPICAL 20060713 ANDA ANDA077547 Global Pharmaceuticals, Division of Impax Laboratories Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0115-1475_414f16cb-bb55-4ddc-8da6-bdc4fb60a43e 0115-1475 HUMAN PRESCRIPTION DRUG Calcipotriene Calcipotriene SOLUTION TOPICAL 20091120 ANDA ANDA077029 Global Pharmaceuticals, Division of Impax Laboratories Inc. CALCIPOTRIENE .05 mg/mL Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 0115-1476_6ac015dd-8d4e-4dc9-acbc-f69e0613371d 0115-1476 HUMAN PRESCRIPTION DRUG Imiquimod Imiquimod CREAM TOPICAL 20110228 ANDA ANDA091044 Global Pharmaceuticals, Division of Impax Laboratories Inc. IMIQUIMOD 50 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 0115-1483_352da3e2-2786-424b-9c9f-47b9948bc64a 0115-1483 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium GEL TOPICAL 20131121 ANDA ANDA200936 Global Pharmaceuticals, Division of Impax Laboratories Inc. DICLOFENAC SODIUM 30 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0115-1494_8f5dbc5a-fe98-42c5-a64f-b54ce51cf780 0115-1494 HUMAN PRESCRIPTION DRUG Sevelamer Carbonate sevelamer carbonate TABLET, FILM COATED ORAL 20140416 NDA AUTHORIZED GENERIC NDA022127 Global Pharmaceuticals Division of IMPAX Laboratories, Inc. SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 0115-1524_ec705d9d-c0a0-4446-98d9-88ebb475874b 0115-1524 HUMAN PRESCRIPTION DRUG URSODIOL URSODIOL TABLET, FILM COATED ORAL 20111223 ANDA ANDA200826 Global Pharmaceuticals, Division of Impax Laboratories, Inc. URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 0115-1525_ec705d9d-c0a0-4446-98d9-88ebb475874b 0115-1525 HUMAN PRESCRIPTION DRUG URSODIOL URSODIOL TABLET, FILM COATED ORAL 20111223 ANDA ANDA200826 Global Pharmaceuticals, Division of Impax Laboratories, Inc. URSODIOL 500 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 0115-1811_98c89104-46cc-4ea1-bda0-aac7aca6d62b 0115-1811 HUMAN PRESCRIPTION DRUG FLAVOXATE HYDROCHLORIDE FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED ORAL 20030828 ANDA ANDA076234 Global Pharmaceuticals FLAVOXATE HYDROCHLORIDE 100 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0115-1911_4d4d38c0-af8a-4e3c-8bc7-d8f3c0b2299b 0115-1911 HUMAN PRESCRIPTION DRUG Rimantadine Hydrochloride Rimantadine Hydrochloride TABLET, FILM COATED ORAL 20050401 ANDA ANDA076132 Global Pharmaceuticals, Division of Impax Laboratories Inc. RIMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 0115-2011_d983fcd0-bbad-4561-888c-1adc6b3257cf 0115-2011 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE ORAL 20000623 ANDA ANDA040368 Global Pharmaceuticals, Division of Impax Laboratories Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0115-2111_17520e02-9937-4258-ac29-4e534bae4f8b 0115-2111 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET, FILM COATED ORAL 20040322 ANDA ANDA065094 Global Pharmaceuticals, Division of Impax Laboratories, Inc. DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 0115-2122_17520e02-9937-4258-ac29-4e534bae4f8b 0115-2122 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET, FILM COATED ORAL 20040322 ANDA ANDA065094 Global Pharmaceuticals, Division of Impax Laboratories, Inc. DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 0115-2611_6842e10e-3287-400a-9785-a72535b34594 0115-2611 HUMAN PRESCRIPTION DRUG TERBUTALINE SULFATE TERBUTALINE SULFATE TABLET ORAL 20010626 ANDA ANDA075877 Global Pharmaceuticals, Division of Impax Laboratories Inc. TERBUTALINE SULFATE 2.5 mg/1 0115-2622_6842e10e-3287-400a-9785-a72535b34594 0115-2622 HUMAN PRESCRIPTION DRUG TERBUTALINE SULFATE TERBUTALINE SULFATE TABLET ORAL 20010626 ANDA ANDA075877 Global Pharmaceuticals, Division of Impax Laboratories Inc. TERBUTALINE SULFATE 5 mg/1 0115-2711_c8e72233-993c-49af-b59c-def2d4b9979b 0115-2711 HUMAN PRESCRIPTION DRUG SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET ORAL 20001107 ANDA ANDA075663 Global Pharmaceuticals SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 0115-2722_c8e72233-993c-49af-b59c-def2d4b9979b 0115-2722 HUMAN PRESCRIPTION DRUG SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET ORAL 20001107 ANDA ANDA075663 Global Pharmaceuticals SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC] 0115-2733_c8e72233-993c-49af-b59c-def2d4b9979b 0115-2733 HUMAN PRESCRIPTION DRUG SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET ORAL 20001107 ANDA ANDA075663 Global Pharmaceuticals SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC] 0115-2744_c8e72233-993c-49af-b59c-def2d4b9979b 0115-2744 HUMAN PRESCRIPTION DRUG SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE TABLET ORAL 20001107 ANDA ANDA075663 Global Pharmaceuticals SOTALOL HYDROCHLORIDE 240 mg/1 Antiarrhythmic [EPC] 0115-2790_23ddc903-ef70-4148-b311-00733a57b153 0115-2790 HUMAN PRESCRIPTION DRUG Chloroquine Phosphate CHLOROQUINE PHOSPHATE TABLET ORAL 19741211 ANDA ANDA080880 Global Pharmaceuticals, Division of Impax Laboratories, Inc. CHLOROQUINE PHOSPHATE 250 mg/1 Antimalarial [EPC] 0115-3000_dc901961-112a-473d-87f7-dcffddc52a66 0115-3000 HUMAN PRESCRIPTION DRUG Riluzole RILUZOLE TABLET, FILM COATED ORAL 20030129 ANDA ANDA076173 Global Pharmaceuticals, Division of Impax Laboratories, Inc. RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] 0115-3511_65e1903c-857a-4e4d-bbfb-d16e6376ba1d 0115-3511 HUMAN PRESCRIPTION DRUG Pyridostigmine Bromide PYRIDOSTIGMINE BROMIDE TABLET ORAL 20030424 ANDA ANDA040502 Global Pharmaceuticals, Division of Impax Laboratories Inc. PYRIDOSTIGMINE BROMIDE 60 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0115-3911_0707431b-0f5e-4dee-8d2c-f121592ef0b6 0115-3911 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa CARBIDOPA and LEVODOPA TABLET, EXTENDED RELEASE ORAL 20040514 ANDA ANDA076521 Global Pharmaceuticals, Division of Impax Laboratories Inc. CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0115-3922_0707431b-0f5e-4dee-8d2c-f121592ef0b6 0115-3922 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa CARBIDOPA and LEVODOPA TABLET, EXTENDED RELEASE ORAL 20040514 ANDA ANDA076521 Global Pharmaceuticals, Division of Impax Laboratories Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0115-4211_f5d3e40f-9ba3-4ca7-a717-7d8257ff82b2 0115-4211 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20040527 ANDA ANDA076449 Global Pharmaceuticals, Division of Impax Laboratories Inc. MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0115-4222_f5d3e40f-9ba3-4ca7-a717-7d8257ff82b2 0115-4222 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20040527 ANDA ANDA076449 Global Pharmaceuticals, Division of Impax Laboratories Inc. MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0115-4233_f5d3e40f-9ba3-4ca7-a717-7d8257ff82b2 0115-4233 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20051216 ANDA ANDA076449 Global Pharmaceuticals, Division of Impax Laboratories Inc. MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0115-4411_8d843823-6c6c-40e5-aba6-7fc9f781020f 0115-4411 HUMAN PRESCRIPTION DRUG Dantrolene Sodium Dantrolene Sodium CAPSULE ORAL 20050301 ANDA ANDA076856 Global Pharmaceuticals, Division of Impax Laboratories Inc. DANTROLENE SODIUM 25 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] 0115-4422_8d843823-6c6c-40e5-aba6-7fc9f781020f 0115-4422 HUMAN PRESCRIPTION DRUG Dantrolene Sodium Dantrolene Sodium CAPSULE ORAL 20050301 ANDA ANDA076856 Global Pharmaceuticals, Division of Impax Laboratories Inc. DANTROLENE SODIUM 50 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] 0115-4433_8d843823-6c6c-40e5-aba6-7fc9f781020f 0115-4433 HUMAN PRESCRIPTION DRUG Dantrolene Sodium Dantrolene Sodium CAPSULE ORAL 20050301 ANDA ANDA076856 Global Pharmaceuticals, Division of Impax Laboratories Inc. DANTROLENE SODIUM 100 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] 0115-5211_0866c3ae-7ac1-408e-9017-f88cd81a14f0 0115-5211 HUMAN PRESCRIPTION DRUG COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20061024 ANDA ANDA077510 Global Pharmaceuticals, Division of Impax Laboratories Inc. COLESTIPOL HYDROCHLORIDE 1 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 0115-5212_d5b3d83a-3be7-48e8-b3a5-5e60d5519569 0115-5212 HUMAN PRESCRIPTION DRUG COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE SUSPENSION ORAL 20060502 ANDA ANDA077277 Global Pharmaceuticals, Division of Impax Laboratories Inc. COLESTIPOL HYDROCHLORIDE 5 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 0115-5213_d5b3d83a-3be7-48e8-b3a5-5e60d5519569 0115-5213 HUMAN PRESCRIPTION DRUG COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE SUSPENSION ORAL 20060502 ANDA ANDA077277 Global Pharmaceuticals, Division of Impax Laboratories Inc. COLESTIPOL HYDROCHLORIDE 5 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 0115-5311_6e424468-1209-4462-93fe-bccdd45d2ff2 0115-5311 HUMAN PRESCRIPTION DRUG Nadolol and Bendroflumethiazide NADOLOL and BENDROFLUMETHIAZIDE TABLET ORAL 20070330 ANDA ANDA077833 Global Pharmaceuticals, Division of Impax Laboratories, Inc. BENDROFLUMETHIAZIDE; NADOLOL 5; 40 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0115-5322_6e424468-1209-4462-93fe-bccdd45d2ff2 0115-5322 HUMAN PRESCRIPTION DRUG Nadolol and Bendroflumethiazide NADOLOL and BENDROFLUMETHIAZIDE TABLET ORAL 20070330 ANDA ANDA077833 Global Pharmaceuticals, Division of Impax Laboratories, Inc. BENDROFLUMETHIAZIDE; NADOLOL 5; 80 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0115-5445_b63446e2-3b6d-467a-ab92-73820a5fb5c1 0115-5445 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041203 ANDA ANDA076711 Global Pharmaceuticals, Division of Impax Laboratories Inc. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0115-5511_804d8060-5c3c-4068-9c50-f96c96a097b6 0115-5511 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20100201 ANDA ANDA076509 Global Pharmaceuticals, Division of Impax Laboratories Inc. FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0115-5522_804d8060-5c3c-4068-9c50-f96c96a097b6 0115-5522 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20100201 ANDA ANDA076509 Global Pharmaceuticals, Division of Impax Laboratories Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0115-5911_929bf2f7-502d-4dce-9590-504720bd97b5 0115-5911 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20070501 ANDA ANDA077248 Global Pharmaceuticals, Division of Impax Laboratories, Inc. PILOCARPINE HYDROCHLORIDE 7.5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 0115-5922_929bf2f7-502d-4dce-9590-504720bd97b5 0115-5922 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20070501 ANDA ANDA077248 Global Pharmaceuticals, Division of Impax Laboratories, Inc. PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 0115-6811_48e6aae0-f5c2-461a-a44e-b4792fd34e71 0115-6811 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090501 ANDA ANDA077415 Global Pharmaceuticals, Division of Impax Laboratories, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0115-6911_cf194488-da12-4e09-bee5-6e254a358884 0115-6911 HUMAN PRESCRIPTION DRUG Divalproex Sodium DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA078791 Global Pharmaceuticals, Division of Impax Laboratories Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0115-6922_cf194488-da12-4e09-bee5-6e254a358884 0115-6922 HUMAN PRESCRIPTION DRUG Divalproex Sodium DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA078791 Global Pharmaceuticals, Division of Impax Laboratories Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0115-7010_7783efe9-0201-42d3-b36b-d3ecc3e11c34 0115-7010 HUMAN PRESCRIPTION DRUG Chloroquine Phosphate CHLOROQUINE PHOSPHATE TABLET ORAL 20051101 ANDA ANDA040516 Global Pharmaceuticals, Division of Impax Laboratories, Inc. CHLOROQUINE PHOSPHATE 500 mg/1 Antimalarial [EPC] 0115-7017_13d8dea9-5f80-45e6-8a0e-9b4fd34a560f 0115-7017 HUMAN PRESCRIPTION DRUG MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE ORAL 19990323 ANDA ANDA065005 Global Pharmaceuticals, Division of Impax Laboratories Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0115-7018_13d8dea9-5f80-45e6-8a0e-9b4fd34a560f 0115-7018 HUMAN PRESCRIPTION DRUG MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE ORAL 19990323 ANDA ANDA065005 Global Pharmaceuticals, Division of Impax Laboratories Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0115-7033_dda5209c-8585-4750-a81f-3a4314ecf966 0115-7033 HUMAN PRESCRIPTION DRUG Fludrocortisone Acetate FLUDROCORTISONE ACETATE TABLET ORAL 20020318 ANDA ANDA040431 Global Pharmaceuticals, Division of Impax Laboratories, Inc. FLUDROCORTISONE ACETATE .1 mg/1 0115-7037_971271a7-ba3d-4817-94ff-dac32e6f99d8 0115-7037 HUMAN PRESCRIPTION DRUG METHITEST METHYLTESTOSTERONE TABLET ORAL 19741017 ANDA ANDA080767 Global Pharmaceuticals, Division of Impax Laboratories Inc. METHYLTESTOSTERONE 10 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0115-7054_13d8dea9-5f80-45e6-8a0e-9b4fd34a560f 0115-7054 HUMAN PRESCRIPTION DRUG MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE ORAL 19990323 ANDA ANDA065005 Global Pharmaceuticals, Division of Impax Laboratories Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0115-8211_f3765f1a-523f-43d9-879e-b894b48c56a1 0115-8211 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100302 ANDA ANDA090377 Global Pharmaceuticals, Division of Impax Laboratories Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0115-8311_46aae948-1edb-4f90-b534-c1c479e14c78 0115-8311 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070524 ANDA ANDA077968 Global Pharmaceuticals, Division of Impax Laboratories Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0115-8322_46aae948-1edb-4f90-b534-c1c479e14c78 0115-8322 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070524 ANDA ANDA077968 Global Pharmaceuticals, Division of Impax Laboratories Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0115-8333_46aae948-1edb-4f90-b534-c1c479e14c78 0115-8333 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070524 ANDA ANDA077968 Global Pharmaceuticals, Division of Impax Laboratories Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0115-8344_46aae948-1edb-4f90-b534-c1c479e14c78 0115-8344 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070524 ANDA ANDA077968 Global Pharmaceuticals, Division of Impax Laboratories Inc. ALPRAZOLAM 3 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0115-9511_3bf679c5-08dd-410e-b5fb-9d3dd176109e 0115-9511 HUMAN PRESCRIPTION DRUG Bethanechol Chloride BETHANECHOL CHLORIDE TABLET ORAL 20070501 ANDA ANDA040739 Global Pharmaceuticals, Division of Impax Laboratories, Inc. BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0115-9522_3bf679c5-08dd-410e-b5fb-9d3dd176109e 0115-9522 HUMAN PRESCRIPTION DRUG Bethanechol Chloride BETHANECHOL CHLORIDE TABLET ORAL 20070501 ANDA ANDA040741 Global Pharmaceuticals, Division of Impax Laboratories, Inc. BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0115-9533_3bf679c5-08dd-410e-b5fb-9d3dd176109e 0115-9533 HUMAN PRESCRIPTION DRUG Bethanechol Chloride BETHANECHOL CHLORIDE TABLET ORAL 20070501 ANDA ANDA040740 Global Pharmaceuticals, Division of Impax Laboratories, Inc. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0115-9544_3bf679c5-08dd-410e-b5fb-9d3dd176109e 0115-9544 HUMAN PRESCRIPTION DRUG Bethanechol Chloride BETHANECHOL CHLORIDE TABLET ORAL 20070501 ANDA ANDA040721 Global Pharmaceuticals, Division of Impax Laboratories, Inc. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0115-9611_a3cc66c4-39da-4578-a16f-c8d6bbca1da7 0115-9611 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20091201 ANDA ANDA078099 Global Pharmaceuticals, Division of Impax Laboratories Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0115-9622_a3cc66c4-39da-4578-a16f-c8d6bbca1da7 0115-9622 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20091201 ANDA ANDA078099 Global Pharmaceuticals, Division of Impax Laboratories Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0115-9633_a3cc66c4-39da-4578-a16f-c8d6bbca1da7 0115-9633 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20091201 ANDA ANDA078099 Global Pharmaceuticals, Division of Impax Laboratories Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0115-9811_1a650451-8648-4771-93da-553ccf81e6e9 0115-9811 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20090720 ANDA ANDA078556 Global Pharmaceuticals, Division of Impax Laboratories Inc. DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0115-9822_1a650451-8648-4771-93da-553ccf81e6e9 0115-9822 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20090720 ANDA ANDA078556 Global Pharmaceuticals, Division of Impax Laboratories Inc. DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0115-9911_44a32960-bbe8-4982-92da-28374563acf1 0115-9911 HUMAN PRESCRIPTION DRUG GEMFIBROZIL GEMFIBROZIL TABLET, COATED ORAL 20091001 ANDA ANDA078207 Global Pharmaceuticals, Division of Impax Laboratories Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0116-1021_e522cf1d-a1fb-4bc0-b5da-99e69872a617 0116-1021 HUMAN OTC DRUG Dyna-Hex 2 CHLORHEXIDINE GLUCONATE LIQUID TOPICAL 20140101 NDA NDA019422 Xttirum Laboratories, Inc. CHLORHEXIDINE GLUCONATE 2 g/100mL 0116-1061_49aa6c3c-9593-42f2-afbb-fb0f59537122 0116-1061 HUMAN OTC DRUG ANTISEPTIC SKIN CLEANSER CHLORHEXIDINE GLUCONATE SOLUTION TOPICAL 20110831 NDA NDA019125 Xttrium Laboratories, Inc. CHLORHEXIDINE GLUCONATE 4 g/100mL 0116-2001_ad2f26ce-fcab-4a96-b099-c00811d7c7a5 0116-2001 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20090801 ANDA ANDA077789 Xttrium Laboratories, Inc. CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] 0116-2994_0f2b1d94-25d8-40d9-8c40-8dff81954f8d 0116-2994 HUMAN OTC DRUG Scrub Care Exidine -4 CHG Chlorhexidine gluconate LIQUID TOPICAL 19900801 NDA NDA019125 Xttrium Laboratories, Inc. CHLORHEXIDINE GLUCONATE 4 mg/100mL 0121-0431_101a578b-aab6-4fce-9c90-d184dd9fd441 0121-0431 HUMAN OTC DRUG Milk of Magnesia Magnesium Hydroxide SUSPENSION ORAL 19790904 OTC MONOGRAPH FINAL part331 Pharmaceutical Associates, Inc. MAGNESIUM HYDROXIDE 400 mg/5mL 0121-0489_5716ef9b-5d87-46c7-a465-58071a2ee3bc 0121-0489 HUMAN PRESCRIPTION DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 19820210 ANDA ANDA087513 Pharmaceutical Associates, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0121-0504_d204d8d1-c182-4d05-a009-00a8d4e4913d 0121-0504 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate ACETAMINOPHEN and CODEINE PHOSPHATE SOLUTION ORAL 19810821 ANDA ANDA087508 Pharmaceutical Associates, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL CV 0121-0527_7e639f77-1e43-45cf-a585-8e7ffa1784c5 0121-0527 HUMAN OTC DRUG MILK OF MAGNESIA MAGNESIUM HYDROXIDE SUSPENSION ORAL 19820420 OTC MONOGRAPH FINAL part331 Pharmaceutical Associates, Inc. MAGNESIUM HYDROXIDE 2400 mg/10mL 0121-0544_191be163-b9ec-4ed6-8e88-990b33fc8e08 0121-0544 HUMAN OTC DRUG Docusate Sodium Docusate Sodium LIQUID ORAL 19830216 OTC MONOGRAPH NOT FINAL part334 Pharmaceutical Associates, Inc. DOCUSATE SODIUM 50 mg/5mL 0121-0547_f42373cd-3894-4b6f-8995-c45f96e931cb 0121-0547 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP ORAL 19881222 ANDA ANDA089647 Pharmaceutical Associates, Inc. CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 0121-0576_9cdbcf47-d27c-4e8c-b988-0642190bf6f4 0121-0576 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride SOLUTION ORAL 19910601 ANDA ANDA072744 Pharmaceutical Associates, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0121-0577_8c740380-0849-4d38-952c-711ecee52e1b 0121-0577 HUMAN PRESCRIPTION DRUG LACTULOSE LACTULOSE SOLUTION ORAL 19660730 ANDA ANDA074623 Pharmaceutical Associates, Inc, LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 0121-0581_e3fe7e7c-9589-4381-bc75-090bf7b0c96d 0121-0581 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol SOLUTION, CONCENTRATE ORAL 20091110 ANDA ANDA073037 Pharmaceutical Associates, Inc. HALOPERIDOL 2 mg/mL Typical Antipsychotic [EPC] 0121-0595_d0d2db48-b6d4-495b-8029-8e8f3b8c07eb 0121-0595 HUMAN PRESCRIPTION DRUG Sodium Citrate and Citric Acid SODIUM CITRATE and CITRIC ACID MONOHYDRATE SOLUTION ORAL 19690101 UNAPPROVED DRUG OTHER Pharmaceutical Associates, Inc. CITRIC ACID MONOHYDRATE; SODIUM CITRATE 334; 500 mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0121-0638_ae45febb-29db-43e3-b407-3a50bbb7323d 0121-0638 HUMAN OTC DRUG GUAIFENESIN DM GUAIFENESIN and DEXTROMETHORPHAN SYRUP ORAL 19920701 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. DEXTROMETHORPHAN; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 0121-0646_1be36e11-a560-4ca5-a9b1-1c002ee996ad 0121-0646 HUMAN PRESCRIPTION DRUG AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE SOLUTION ORAL 19950717 ANDA ANDA074509 Pharmaceutical Associates, Inc. AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 0121-0653_abe173eb-bb83-439a-9bca-6461348dffd7 0121-0653 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride SOLUTION, CONCENTRATE ORAL 20100901 ANDA ANDA074725 Pharmaceutical Associates, Inc. FLUPHENAZINE HYDROCHLORIDE 5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0121-0654_94db77a7-ca1c-4475-82b5-3b9861b05b69 0121-0654 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride ELIXIR ORAL 20100831 ANDA ANDA040106 Pharmaceutical Associates, Inc. FLUPHENAZINE HYDROCHLORIDE .5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0121-0657_d29d15b6-ad06-4783-ae9c-387ec3fb8b4b 0121-0657 HUMAN OTC DRUG Acetaminophen Acetaminophen SOLUTION ORAL 20070801 OTC MONOGRAPH NOT FINAL part343 Pharmaceutical Associates, Inc. ACETAMINOPHEN 160 mg/5mL 0121-0658_bc83a315-b1dd-44ba-80e4-5f0beae2fb30 0121-0658 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride SOLUTION ORAL 19970515 ANDA ANDA040177 Pharmaceutical Associates, Inc. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/5mL 0121-0670_92a08a29-d0a7-42a6-8fd5-0d53e70f0071 0121-0670 HUMAN PRESCRIPTION DRUG ETHOSUXIMIDE ETHOSUXIMIDE SOLUTION ORAL 20001122 ANDA ANDA040253 Pharmaceutical Associates, Inc. ETHOSUXIMIDE 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0121-0671_2000b665-7d6f-415b-b9d5-d4eca54a241b 0121-0671 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE SYRUP ORAL 19981218 ANDA ANDA075137 Pharmaceutical Associates, Inc. OXYBUTYNIN CHLORIDE 5 mg/5mL Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0121-0675_9a5172ac-529f-412d-a35f-51ce186927ff 0121-0675 HUMAN PRESCRIPTION DRUG Valproic Acid VALPROIC ACID SOLUTION ORAL 20050411 ANDA ANDA075379 Pharmaceutical Associates, Inc. VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0121-0676_71913577-5b5e-4f35-a016-b7f2660e92bf 0121-0676 HUMAN PRESCRIPTION DRUG Potassium Citrate and Citric Acid Potassium Citrate and Citric Acid Monohydrate SOLUTION ORAL 19971007 UNAPPROVED DRUG OTHER Pharmaceutical Associates, Inc. CITRIC ACID MONOHYDRATE; POTASSIUM CITRATE 334; 1100 mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0121-0677_57e16fd9-afb8-498f-9c46-ebd46cfaedc4 0121-0677 HUMAN PRESCRIPTION DRUG TRICITRATES POTASSIUM CITRATE, SODIUM CITRATE, and CITRIC ACID MONOHYDRATE SOLUTION ORAL 20050525 UNAPPROVED DRUG OTHER Pharmaceutical Associates, Inc. CITRIC ACID MONOHYDRATE; POTASSIUM CITRATE; SODIUM CITRATE 334; 550; 500 mg/5mL; mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0121-0678_afda75c8-c42c-40f4-ac81-179b3bf0b223 0121-0678 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride SOLUTION ORAL 20000823 ANDA ANDA075606 Pharmaceutical Associates, Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/5mL Tricyclic Antidepressant [EPC] 0121-0721_74d82975-faad-40e6-a50d-e66e4b34112d 0121-0721 HUMAN PRESCRIPTION DRUG Fluoxetine FLUOXETINE HYDROCHLORIDE SOLUTION ORAL 20020130 ANDA ANDA076015 Pharmaceutical Associates, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0121-0727_92bad7f0-8ec4-403d-b285-4809012b9fbc 0121-0727 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SOLUTION ORAL 20090919 ANDA ANDA077405 Pharmaceutical Associates, Inc. RANITIDINE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0121-0744_b2864016-bb8d-46f5-b4c5-d192b5d96c0e 0121-0744 HUMAN OTC DRUG GUAIFENESIN GUAIFENESIN SOLUTION ORAL 20020901 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. GUAIFENESIN 100 mg/5mL 0121-0747_949ebfcc-afcf-439e-8314-ffa6daf31640 0121-0747 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate SUSPENSION ORAL 20091119 NDA NDA019183 Pharmaceutical Associates, Inc. SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 0121-0759_3aaa91d4-15ae-41e4-bb5e-4f6d315c4452 0121-0759 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20050425 ANDA ANDA076913 Pharmaceutical Associates, Inc. PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0121-0766_c2bfaeaa-1ed1-46e5-84b2-3a20c46eb9f4 0121-0766 HUMAN OTC DRUG Calcium Carbonate Calcium Carbonate SUSPENSION ORAL 20041201 OTC MONOGRAPH FINAL part331 Pharmaceutical Associates, Inc. CALCIUM CARBONATE 1250 mg/5mL 0121-0770_e16394ef-e63c-429e-9e9a-fd064d8a1732 0121-0770 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam LIQUID ORAL 20101101 ANDA ANDA090260 Pharmaceutical Associates, Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0121-0772_40abeec9-673b-4385-b38b-9a01b582cba9 0121-0772 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20130729 ANDA ANDA040838 Pharmaceutical Associates, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0121-0775_9b447bdc-8ff9-4010-8e9a-6a961f94a2c8 0121-0775 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate SOLUTION ORAL 20061001 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 0121-0788_fc72c9e4-1bc6-4d5c-b4e9-ca85e11dc8ba 0121-0788 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE CYPROHEPTADINE SYRUP ORAL 20130729 ANDA ANDA091295 Pharmaceutical Associates, Inc. CYPROHEPTADINE 2 mg/5mL 0121-0809_58f894c7-263c-433a-af8d-7073c7079917 0121-0809 HUMAN OTC DRUG Guaifenesin DM GUAIFENESIN and DEXTROMETHORPHAN SOLUTION ORAL 20100517 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. DEXTROMETHORPHAN; GUAIFENESIN 10; 200 mg/5mL; mg/5mL 0121-1465_e12f1141-9061-4e64-a144-8299bc74954b 0121-1465 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE SOLUTION ORAL 19690101 UNAPPROVED DRUG OTHER Pharmaceutical Associates, Inc. POTASSIUM CHLORIDE 1.5 g/15mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0121-1576_9cdbcf47-d27c-4e8c-b988-0642190bf6f4 0121-1576 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride SOLUTION ORAL 19910601 ANDA ANDA072744 Pharmaceutical Associates, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0121-1744_b2864016-bb8d-46f5-b4c5-d192b5d96c0e 0121-1744 HUMAN OTC DRUG GUAIFENESIN GUAIFENESIN SOLUTION ORAL 20020901 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. GUAIFENESIN 100 mg/5mL 0121-1760_590dd219-4a17-43d7-88d6-2bac02ba562c 0121-1760 HUMAN OTC DRUG Mag-AL Liquid Aluminum Hydroxide and Magnesium Hydroxide SUSPENSION ORAL 20040114 OTC MONOGRAPH FINAL part331 Pharmaceutical Associates, Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE 200; 200 mg/5mL; mg/5mL 0121-1761_8b4e59b7-d1f2-4e98-a610-c24071c543f9 0121-1761 HUMAN OTC DRUG Mag-AL Plus Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone SUSPENSION ORAL 20040114 OTC MONOGRAPH FINAL part331 Pharmaceutical Associates, Inc. ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 0121-1762_11928a48-9b30-4547-baaa-76e89599611c 0121-1762 HUMAN OTC DRUG Mag-AL Plus XS Aluminum Hydroxide, Magnesium Hydroxide, and Dimethicone SUSPENSION ORAL 20040114 OTC MONOGRAPH FINAL part331 Pharmaceutical Associates, Inc. ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 0121-1775_9b447bdc-8ff9-4010-8e9a-6a961f94a2c8 0121-1775 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate SOLUTION ORAL 20061001 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 0121-4577_8c740380-0849-4d38-952c-711ecee52e1b 0121-4577 HUMAN PRESCRIPTION DRUG LACTULOSE LACTULOSE SOLUTION ORAL 19660730 ANDA ANDA074623 Pharmaceutical Associates, Inc, LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 0121-4655_0eb4ce5d-e940-4412-ab84-d7959c010640 0121-4655 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20110101 ANDA ANDA040182 Pharmaceutical Associates, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 167; 2.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0121-4675_9a5172ac-529f-412d-a35f-51ce186927ff 0121-4675 HUMAN PRESCRIPTION DRUG Valproic Acid VALPROIC ACID SOLUTION ORAL 20050411 ANDA ANDA075379 Pharmaceutical Associates, Inc. VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0121-4721_74d82975-faad-40e6-a50d-e66e4b34112d 0121-4721 HUMAN PRESCRIPTION DRUG Fluoxetine FLUOXETINE HYDROCHLORIDE SOLUTION ORAL 20020201 ANDA ANDA076015 Pharmaceutical Associates, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0121-4727_92bad7f0-8ec4-403d-b285-4809012b9fbc 0121-4727 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SOLUTION ORAL 20090919 ANDA ANDA077405 Pharmaceutical Associates, Inc. RANITIDINE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0121-4766_c2bfaeaa-1ed1-46e5-84b2-3a20c46eb9f4 0121-4766 HUMAN OTC DRUG Calcium Carbonate Calcium Carbonate SUSPENSION ORAL 20041201 OTC MONOGRAPH FINAL part331 Pharmaceutical Associates, Inc. CALCIUM CARBONATE 1250 mg/5mL 0121-4771_bda6a236-c3b9-466e-b38a-335d7ab3591d 0121-4771 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20080818 ANDA ANDA040834 Pharmaceutical Associates, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 163; 5 mg/7.5mL; mg/7.5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0121-4772_40abeec9-673b-4385-b38b-9a01b582cba9 0121-4772 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20130729 ANDA ANDA040838 Pharmaceutical Associates, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0121-4774_bce2dff0-b80a-472f-9620-f45d26fefa81 0121-4774 HUMAN PRESCRIPTION DRUG Ibuprofen IBUPROFEN SUSPENSION ORAL 20040923 ANDA ANDA076925 Pharmaceutical Associates, Inc. IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0121-4776_0678ee75-8bff-419a-b10f-123ddac98f0d 0121-4776 HUMAN PRESCRIPTION DRUG Megestrol Acetate MEGESTROL ACETATE SUSPENSION ORAL 20060707 ANDA ANDA076721 Pharmaceutical Associates, Inc. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0121-4780_4a1a8f26-6fea-49cd-85cc-9e7ea7e7eee8 0121-4780 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SYRUP ORAL 20090915 ANDA ANDA090300 Pharmaceutical Associates, Inc. CETIRIZINE HYDROCHLORIDE 5 mg/5mL 0121-4785_7f6f191e-0969-4d20-8189-e65fb74bad39 0121-4785 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20090601 ANDA ANDA062512 Pharmaceutical Associates, Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 0121-4788_fc72c9e4-1bc6-4d5c-b4e9-ca85e11dc8ba 0121-4788 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE CYPROHEPTADINE SYRUP ORAL 20130729 ANDA ANDA091295 Pharmaceutical Associates, Inc. CYPROHEPTADINE 2 mg/5mL 0121-4793_024deb75-5165-4051-960d-e3376f4c8a92 0121-4793 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 20080702 ANDA ANDA077612 Pharmaceutical Associates, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0121-4794_d0cc7207-c3ca-4f0b-99b6-82409a0a0255 0121-4794 HUMAN PRESCRIPTION DRUG Theophylline THEOPHYLLINE ANHYDROUS SOLUTION ORAL 20081103 ANDA ANDA085186 Pharmaceutical Associates, Inc. THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0121-4802_6896783a-f114-4488-8538-2cd46eb21460 0121-4802 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM SOLUTION ORAL 20090211 ANDA ANDA090028 Pharmaceutical Associates, Inc. LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0121-4803_e58126c2-3e53-46eb-8c75-367d45aa84bd 0121-4803 HUMAN OTC DRUG Pink Bismuth Bismuth Subsalicylate SUSPENSION ORAL 20090920 OTC MONOGRAPH FINAL part335 Pharmaceutical Associates, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL 0121-4809_58f894c7-263c-433a-af8d-7073c7079917 0121-4809 HUMAN OTC DRUG Guaifenesin DM GUAIFENESIN and DEXTROMETHORPHAN SOLUTION ORAL 20100517 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. DEXTROMETHORPHAN; GUAIFENESIN 10; 200 mg/5mL; mg/5mL 0121-4811_cdf89537-b161-47de-b7d2-a8df29834e85 0121-4811 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide SYRUP ORAL 20091228 ANDA ANDA088008 Pharmaceutical Associates, Inc. HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5; 5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0126-0016_e3eb69a6-969e-4833-8032-deef1e43f969 0126-0016 HUMAN PRESCRIPTION DRUG PreviDent 5000 Dry Mouth Sodium fluoride GEL, DENTIFRICE DENTAL 20090706 UNAPPROVED DRUG OTHER Colgate-Palmolive Company SODIUM FLUORIDE 13.5 mg/mL 0126-0021_48d783af-cd13-454c-b061-ea713b967024 0126-0021 HUMAN OTC DRUG Colgate Dry Mouth Relief SODIUM FLUORIDE RINSE DENTAL 20110114 OTC MONOGRAPH FINAL part355 Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 2.1 mg/10mL 0126-0022_430a6a1e-1089-4626-8965-c0875303b4f2 0126-0022 HUMAN PRESCRIPTION DRUG PreviDent 5000 Enamel Protect SODIUM FLUORIDE and POTASSIUM NITRATE GEL, DENTIFRICE DENTAL 20110330 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. POTASSIUM NITRATE; SODIUM FLUORIDE 57.5; 12.7 mg/mL; mg/mL 0126-0023_f276116e-cbe3-4827-92f8-59756e15fb81 0126-0023 HUMAN OTC DRUG Colgate Total Freshmint CETYLPYRIDINIUM CHLORIDE MOUTHWASH DENTAL 20100701 OTC MONOGRAPH NOT FINAL part356 Colgate Oral Pharmaceuticals, Inc. CETYLPYRIDINIUM CHLORIDE 10.5 mg/20mL 0126-0024_31dd69c6-cc90-4040-8abc-c79c4670e6c2 0126-0024 HUMAN OTC DRUG Colgate Total Peppermint CETYLPYRIDINIUM CHLORIDE MOUTHWASH DENTAL 20100701 OTC MONOGRAPH NOT FINAL part356 Colgate Oral Pharmaceuticals CETYLPYRIDINIUM CHLORIDE 10.5 mg/20mL 0126-0025_1902b258-2ef3-4b9f-8957-9ab43d2001f7 0126-0025 HUMAN OTC DRUG Colgate Total Gentle Care Softmint CETYLPYRIDINIUM CHLORIDE MOUTHWASH DENTAL 20100701 OTC MONOGRAPH NOT FINAL part356 Colgate Oral Pharmaceuticals, Inc. CETYLPYRIDINIUM CHLORIDE 10.5 mg/20mL 0126-0026_a02bd250-d064-4ccc-9135-c8a3306e79f4 0126-0026 HUMAN OTC DRUG Colgate Total Whitening Sparklemint CETYLPYRIDINIUM CHLORIDE MOUTHWASH DENTAL 20100701 OTC MONOGRAPH NOT FINAL part356 Colgate Oral Pharmaceuticals CETYLPYRIDINIUM CHLORIDE 10.5 mg/20mL 0126-0027_b4e77cb8-e8fd-406e-a83d-9cd512cbb403 0126-0027 HUMAN OTC DRUG Colgate Cavity Protection Great Regular Flavor Sodium Monofluorophosphate PASTE DENTAL 20120203 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM MONOFLUOROPHOSPHATE 11.4 mg/g 0126-0065_4f6f8f15-8007-46c8-9319-9d62e2c9e931 0126-0065 HUMAN OTC DRUG Colgate Orabase Benzocaine PASTE, DENTIFRICE TOPICAL 20100831 OTC MONOGRAPH NOT FINAL part356 Colgate Oral Pharmaceuticals, Inc. BENZOCAINE .02 g/g 0126-0070_e4aefcbf-56d5-457e-8dbc-7704f5b3ed36 0126-0070 HUMAN PRESCRIPTION DRUG PreviDent 5000 Sensitive Sodium fluoride GEL, DENTIFRICE DENTAL 20090706 UNAPPROVED DRUG OTHER Colgate-Palmolive Company POTASSIUM NITRATE; SODIUM FLUORIDE 57.5; 12.7 mg/mL; mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0126-0072_1592027d-3079-422c-a3d2-197a37fe88fb 0126-0072 HUMAN PRESCRIPTION DRUG PreviDent 5000 Enhanced with Calcium Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20121101 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 11 mg/mL 0126-0074_6e0f014d-ed3c-4846-aa39-2025f4210cab 0126-0074 HUMAN PRESCRIPTION DRUG PreviDent 5000 Enhanced with Calcium Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20121101 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 11 mg/mL 0126-0075_33c288df-0d48-404b-b280-88ff8ea4a7fa 0126-0075 HUMAN PRESCRIPTION DRUG PreviDent 5000 Booster Sodium fluoride GEL, DENTIFRICE DENTAL 20090706 UNAPPROVED DRUG OTHER Colgate-Palmolive Company SODIUM FLUORIDE 13.4 mg/mL 0126-0076_92e94b16-8990-4ece-b676-ba5edf0d15c8 0126-0076 HUMAN PRESCRIPTION DRUG PreviDent 5000 Booster Sodium fluoride GEL, DENTIFRICE DENTAL 20090706 UNAPPROVED DRUG OTHER Colgate-Palmolive Company SODIUM FLUORIDE 13.4 mg/mL 0126-0082_a983588f-a259-44e8-b3f0-248d58b05ef3 0126-0082 HUMAN OTC DRUG Orabase Benzocaine Purple Ice Benzocaine PASTE, DENTIFRICE DENTAL 20120801 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. BENZOCAINE 19.8 mg/g 0126-0088_94fc6439-bf26-456b-83ef-9a401a86df79 0126-0088 HUMAN PRESCRIPTION DRUG PreviDent Sodium Fluoride GEL, DENTIFRICE DENTAL 20120829 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 11 mg/g 0126-0131_72640a14-d84e-4b3f-ac27-99ccdbb5cdc0 0126-0131 HUMAN PRESCRIPTION DRUG Phos-Flur Sodium Fluoride GEL, DENTIFRICE DENTAL 20120829 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 11 mg/g 0126-0135_42ea2e6f-8b84-4c6a-9233-aaeca295cf0b 0126-0135 HUMAN OTC DRUG Phos-Flur Ortho Defense SODIUM FLUORIDE RINSE DENTAL 20110112 OTC MONOGRAPH FINAL part355 Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 4.42 mg/10mL 0126-0138_b1c3b16f-fae6-463d-a4e5-d0b5fe4a0b62 0126-0138 HUMAN OTC DRUG Phos-Flur Ortho Defense SODIUM FLUORIDE RINSE DENTAL 20110215 OTC MONOGRAPH FINAL part355 Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 4.42 mg/10mL 0126-0139_bc93d2a8-3a13-4f6d-b915-0e23d5abfcfe 0126-0139 HUMAN OTC DRUG Phos-Flur Ortho Defense SODIUM FLUORIDE RINSE DENTAL 20110211 OTC MONOGRAPH FINAL part355 Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 4.42 mg/10mL 0126-0179_3e8f2dee-5e1c-4666-a5ac-36b1730055d2 0126-0179 HUMAN PRESCRIPTION DRUG PreviDent Sodium Fluoride MOUTHWASH DENTAL 20120829 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 2 mg/mL 0126-0271_1def9951-a4e9-4a87-9952-7b61a46c7e0f 0126-0271 HUMAN PRESCRIPTION DRUG Periogard Chlorhexidine Gluconate LIQUID ORAL 20100302 ANDA ANDA073695 Colgate-Palmolive Company CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] 0126-0286_bbe25b36-c11e-4809-9367-b695a89affa5 0126-0286 HUMAN PRESCRIPTION DRUG PreviDent 5000 Plus Fruitastic Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120829 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 11 mg/mL 0126-0287_56ef544c-b840-4290-9618-c5161fac80a5 0126-0287 HUMAN PRESCRIPTION DRUG PreviDent 5000 Plus Spearmint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120829 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 11 mg/mL 0126-0287_bbe25b36-c11e-4809-9367-b695a89affa5 0126-0287 HUMAN PRESCRIPTION DRUG PreviDent 5000 Plus Spearmint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120829 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 11 mg/mL 0126-0288_94fc6439-bf26-456b-83ef-9a401a86df79 0126-0288 HUMAN PRESCRIPTION DRUG PreviDent Sodium Fluoride GEL, DENTIFRICE DENTAL 20120829 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 11 mg/g 0131-1810_76bcc432-7f49-47c8-9724-f186e28917a9 0131-1810 HUMAN PRESCRIPTION DRUG Vimpat lacosamide INJECTION INTRAVENOUS 20090526 NDA NDA022254 Kremers Urban Pharmaceuticals Inc LACOSAMIDE 10 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV 0131-2470_76bcc432-7f49-47c8-9724-f186e28917a9 0131-2470 HUMAN PRESCRIPTION DRUG Vimpat lacosamide KIT 20090526 NDA NDA022253 Kremers Urban Pharmaceuticals Inc 0131-2477_76bcc432-7f49-47c8-9724-f186e28917a9 0131-2477 HUMAN PRESCRIPTION DRUG Vimpat lacosamide TABLET, FILM COATED ORAL 20090526 NDA NDA022253 Kremers Urban Pharmaceuticals Inc LACOSAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV 0131-2478_76bcc432-7f49-47c8-9724-f186e28917a9 0131-2478 HUMAN PRESCRIPTION DRUG Vimpat lacosamide TABLET, FILM COATED ORAL 20090526 NDA NDA022253 Kremers Urban Pharmaceuticals Inc LACOSAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV 0131-2479_76bcc432-7f49-47c8-9724-f186e28917a9 0131-2479 HUMAN PRESCRIPTION DRUG Vimpat lacosamide TABLET, FILM COATED ORAL 20090526 NDA NDA022253 Kremers Urban Pharmaceuticals Inc LACOSAMIDE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV 0131-2480_76bcc432-7f49-47c8-9724-f186e28917a9 0131-2480 HUMAN PRESCRIPTION DRUG Vimpat lacosamide TABLET, FILM COATED ORAL 20090526 NDA NDA022253 Kremers Urban Pharmaceuticals Inc LACOSAMIDE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV 0131-3265_46596bfd-f89e-46c4-9ff8-e5e19917fb69 0131-3265 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100429 NDA AUTHORIZED GENERIC NDA022104 Kremers Urban Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0131-3266_46596bfd-f89e-46c4-9ff8-e5e19917fb69 0131-3266 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100429 NDA AUTHORIZED GENERIC NDA022104 Kremers Urban Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0131-3267_46596bfd-f89e-46c4-9ff8-e5e19917fb69 0131-3267 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100429 NDA AUTHORIZED GENERIC NDA022104 Kremers Urban Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0131-3268_46596bfd-f89e-46c4-9ff8-e5e19917fb69 0131-3268 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100429 NDA AUTHORIZED GENERIC NDA022104 Kremers Urban Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 225 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0131-5410_76bcc432-7f49-47c8-9724-f186e28917a9 0131-5410 HUMAN PRESCRIPTION DRUG Vimpat lacosamide SOLUTION ORAL 20100420 NDA NDA022255 Kremers Urban Pharmaceuticals Inc LACOSAMIDE 10 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV 0132-0079_234e4613-eb0d-4f4f-9270-ea5c5b7a0486 0132-0079 HUMAN OTC DRUG Fleet Glycerin SUPPOSITORY RECTAL 19841101 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. GLYCERIN 2 g/1 0132-0079_a44b056e-ea6b-4284-90db-0df8561dd456 0132-0079 HUMAN OTC DRUG Fleet Glycerin SUPPOSITORY RECTAL 19841101 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. GLYCERIN 2 g/1 0132-0079_e816b2fa-80e2-4fd2-b271-e557928e65cf 0132-0079 HUMAN OTC DRUG Fleet Glycerin SUPPOSITORY RECTAL 19841101 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. GLYCERIN 2 g/1 0132-0081_4248e5ac-63ca-4b5f-bc1d-2cc9eb7c35b1 0132-0081 HUMAN OTC DRUG Pedia-Lax Glycerin SUPPOSITORY RECTAL 20080301 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. GLYCERIN 1 g/1 0132-0106_1224aee7-957c-41cd-a192-4e94a2f8f819 0132-0106 HUMAN OTC DRUG Pedia-Lax Docusate Sodium LIQUID ORAL 20080301 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. DOCUSATE SODIUM 50 mg/118mL 0132-0185_11ac0112-d65c-40cb-91af-04862b3eae99 0132-0185 HUMAN OTC DRUG Fleet Glycerin LIQUID RECTAL 20020603 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. GLYCERIN 5.4 g/1 0132-0190_8a82f421-81dd-482d-9969-f141ce3a2c7a 0132-0190 HUMAN OTC DRUG Pedia-Lax Glycerin LIQUID RECTAL 20080301 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. GLYCERIN 2.8 g/1 0132-0192_3fafa511-2494-460a-b03f-7b57efe0be91 0132-0192 HUMAN OTC DRUG Boudreauxs Dimethicone CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 C.B. Fleet Company, Inc. DIMETHICONE 4.4 g/44g 0132-0201_de558ad9-eff4-4920-8bbc-6762d82c641c 0132-0201 HUMAN OTC DRUG Fleet sodium phosphate, dibasic and sodium phosphate, monobasic ENEMA RECTAL 20020510 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/133mL; g/133mL 0132-0201_e09a2151-442e-4d18-a14c-424eb224e7e0 0132-0201 HUMAN OTC DRUG Fleet sodium phosphate, dibasic and sodium phosphate, monobasic ENEMA RECTAL 20040625 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/230mL; g/230mL 0132-0202_1b079ae9-862c-4257-9125-fed31464bdbf 0132-0202 HUMAN OTC DRUG Pedia-Lax sodium phosphate, dibasic and sodium phosphate, monobasic ENEMA RECTAL 20020510 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC 3.5; 9.5 g/66mL; g/66mL 0132-0208_7cda841f-d3ce-4cb1-8fd5-05e568fd20ad 0132-0208 HUMAN OTC DRUG PHAZYME Simethicone CAPSULE, GELATIN COATED ORAL 20120201 OTC MONOGRAPH FINAL part332 C.B. Fleet Company, Inc. DIMETHICONE 180 mg/1 0132-0211_efb860e7-3786-4596-8208-f639356ff785 0132-0211 HUMAN OTC DRUG PHAZYME Simethicone CAPSULE, GELATIN COATED ORAL 20140401 OTC MONOGRAPH FINAL part332 C.B. Fleet Company, Inc. DIMETHICONE 250 mg/1 0132-0214_109d9533-a06b-4112-be21-0e5ceb8221b9 0132-0214 HUMAN OTC DRUG PHAZYME Simethicone CAPSULE, GELATIN COATED ORAL 20140401 OTC MONOGRAPH FINAL part332 C.B. Fleet Company, Inc. DIMETHICONE 250 mg/1 0132-0215_0ce39838-3a50-4eb0-bb0c-b7774f3d68a5 0132-0215 HUMAN OTC DRUG PHAZYME Simethicone CAPSULE, GELATIN COATED ORAL 20140401 OTC MONOGRAPH FINAL part332 C.B. Fleet Company, Inc. DIMETHICONE 250 mg/1 0132-0301_cc07b787-9d74-43c7-9efd-7877dd0efe41 0132-0301 HUMAN OTC DRUG Fleet Mineral Oil ENEMA RECTAL 20020501 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. MINERAL OIL 118 mL/118mL 0132-0323_39e0c859-ccc3-4761-a2d9-61099c6bafde 0132-0323 HUMAN OTC DRUG Boudreauxs Zinc Oxide CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part347 C.B. Fleet Company, Inc. ZINC OXIDE 40 g/113g 0132-0333_2df6ffc9-9114-4800-9a21-aa1030a7a665 0132-0333 HUMAN OTC DRUG Boudreauxs Zinc Oxide CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part347 C.B. Fleet Company, Inc. ZINC OXIDE 16 g/113g 0132-0334_27f27fcc-262a-43e0-8b12-defb9d3d68f7 0132-0334 HUMAN OTC DRUG Boudreauxs Zinc Oxide CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part347 C.B. Fleet Company, Inc. ZINC OXIDE 16 g/113g 0132-0655_1d2d5fce-72b8-47b9-bb92-486891bbfbb7 0132-0655 HUMAN OTC DRUG Pedia-Lax Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080301 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. MAGNESIUM HYDROXIDE 400 mg/1 0132-0703_9e1d7272-15c4-4f50-9f45-b24367d3804b 0132-0703 HUMAN OTC DRUG Fleet Bisacodyl ENEMA RECTAL 20020510 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. BISACODYL 10 mg/37mL 0132-0704_c669742d-f88e-478b-8be4-f0f8039a6825 0132-0704 HUMAN OTC DRUG Fleet Bisacodyl TABLET ORAL 20020605 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. BISACODYL 5 mg/1 0132-0751_e334b542-26cc-4f54-9e2e-4cd37dd072a1 0132-0751 HUMAN OTC DRUG Fleet Docusate Sodium CAPSULE, GELATIN COATED ORAL 20020630 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. DOCUSATE SODIUM 100 mg/601 0132-8743_07c648cb-ba5e-402a-91a1-271c43d1ae36 0132-8743 HUMAN OTC DRUG Summers Eve POVIDONE-IODINE DOUCHE VAGINAL 20020510 OTC MONOGRAPH NOT FINAL part330 C.B. Fleet Company, Inc. POVIDONE-IODINE 4 g/133mL 0135-0057_732fa64a-715f-4d21-a0e5-dfd0fb939c1d 0135-0057 HUMAN OTC DRUG Sominex diphenhydramine HCl TABLET ORAL 20101108 20170930 OTC MONOGRAPH FINAL part338 GlaxoSmithKline Consumer Healthcare LP DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0135-0058_732fa64a-715f-4d21-a0e5-dfd0fb939c1d 0135-0058 HUMAN OTC DRUG Sominex diphenhydramine HCl TABLET ORAL 20101108 20150731 OTC MONOGRAPH FINAL part338 GlaxoSmithKline Consumer Healthcare LP DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 0135-0070_79863aed-9c6f-45ef-8248-d2f7209816fd 0135-0070 HUMAN OTC DRUG TUMS calcium carbonate TABLET ORAL 20100310 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 500 mg/1 0135-0071_79863aed-9c6f-45ef-8248-d2f7209816fd 0135-0071 HUMAN OTC DRUG TUMS calcium carbonate TABLET ORAL 20100310 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 500 mg/1 0135-0074_1bdfbc91-a562-4518-947d-0393f5808589 0135-0074 HUMAN OTC DRUG TUMS EX calcium carbonate TABLET ORAL 20100118 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 750 mg/1 0135-0076_1bdfbc91-a562-4518-947d-0393f5808589 0135-0076 HUMAN OTC DRUG TUMS EX calcium carbonate TABLET ORAL 20100118 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 750 mg/1 0135-0077_db720f5a-ddb9-4c43-9322-c172440ea922 0135-0077 HUMAN OTC DRUG VIVARIN caffeine TABLET ORAL 20101108 20150831 OTC MONOGRAPH FINAL part340 GlaxoSmithKline Consumer Healthcare LP CAFFEINE 200 mg/1 0135-0089_58abe1e4-4a95-4ce5-968a-e08e2075311b 0135-0089 HUMAN OTC DRUG CITRUCEL methylcellulose POWDER, FOR SOLUTION ORAL 20100916 OTC MONOGRAPH NOT FINAL part334 GlaxoSmithKline Consumer Healthcare LP METHYLCELLULOSE (4000 MPA.S) 2 g/19g 0135-0090_58abe1e4-4a95-4ce5-968a-e08e2075311b 0135-0090 HUMAN OTC DRUG CITRUCEL methylcellulose POWDER, FOR SOLUTION ORAL 20100916 OTC MONOGRAPH NOT FINAL part334 GlaxoSmithKline Consumer Healthcare LP METHYLCELLULOSE (4000 MPA.S) 2 g/10.2g 0135-0094_e89689fb-f0c5-49c6-a957-d378cd039742 0135-0094 HUMAN OTC DRUG GAVISCON aluminum hydroxide and magnesium carbonate LIQUID ORAL 20110114 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare LP ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 95; 358 mg/15mL; mg/15mL 0135-0095_e89689fb-f0c5-49c6-a957-d378cd039742 0135-0095 HUMAN OTC DRUG GAVISCON aluminum hydroxide and magnesium carbonate LIQUID ORAL 20110114 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare LP ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 254; 237.5 mg/5mL; mg/5mL 0135-0096_d719eb56-6ed3-444e-ba3c-c4ab07dd8492 0135-0096 HUMAN OTC DRUG Gaviscon Regular Strength aluminum hydroxide and magnesium trisilicate TABLET, CHEWABLE ORAL 20110613 NDA NDA018685 GlaxoSmithKline Consumer Healthcare LP ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE 80; 14.2 mg/1; mg/1 0135-0098_d719eb56-6ed3-444e-ba3c-c4ab07dd8492 0135-0098 HUMAN OTC DRUG Gaviscon Extra Strength aluminum hydroxide and magnesium carbonate TABLET, CHEWABLE ORAL 20110613 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare LP ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 0135-0118_3ef5baf0-693c-4a5c-a886-a615f49fe9b1 0135-0118 HUMAN OTC DRUG TUMS ULTRA calcium carbonate TABLET, CHEWABLE ORAL 20100212 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 1000 mg/1 0135-0126_7b876188-e7f4-455d-8597-242f4050e5cc 0135-0126 HUMAN OTC DRUG Aquafresh sodium monofluorophosphate PASTE DENTAL 20110128 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM MONOFLUOROPHOSPHATE 1.1 mg/g 0135-0129_fa955d47-ec1d-435c-afad-174087152b75 0135-0129 HUMAN OTC DRUG Aquafresh Cavity Protection sodium monofluorophosphate PASTE DENTAL 20110128 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g 0135-0130_fa955d47-ec1d-435c-afad-174087152b75 0135-0130 HUMAN OTC DRUG Aquafresh Cavity Protection sodium monofluorophosphate PASTE DENTAL 20110128 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g 0135-0132_fc8d9699-f049-42fd-90bb-74c27c905dc9 0135-0132 HUMAN OTC DRUG AQUAFRESH SENSITIVE MAXIMUM STRENGTH potassium nitrate and sodium fluoride PASTE DENTAL 20110329 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 0135-0135_320a7c9d-f4a1-4299-8703-02b150892c2e 0135-0135 HUMAN OTC DRUG PANADOL Extra Strength acetaminophen TABLET ORAL 20110318 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healtcare LP ACETAMINOPHEN 500 mg/1 0135-0136_320a7c9d-f4a1-4299-8703-02b150892c2e 0135-0136 HUMAN OTC DRUG PANADOL Extra Strength acetaminophen TABLET, FILM COATED ORAL 20110318 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healtcare LP ACETAMINOPHEN 500 mg/1 0135-0140_1bdfbc91-a562-4518-947d-0393f5808589 0135-0140 HUMAN OTC DRUG TUMS EX calcium carbonate TABLET ORAL 20100118 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 750 mg/1 0135-0145_f1b0b6f7-678c-4128-be62-bdcf889437f6 0135-0145 HUMAN OTC DRUG NICODERM CQ nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20110512 NDA NDA020165 GlaxoSmithKline Consumer Healthcare LP NICOTINE 21 mg/24h 0135-0148_1e7eacce-aa82-4e49-bd06-3b95449d6e4b 0135-0148 HUMAN OTC DRUG TAGAMET HB cimetidine TABLET ORAL 20100319 20150930 NDA NDA020238 GlaxoSmithKline Consumer Healthcare LP CIMETIDINE 200 mg/1 0135-0150_d6c31d7d-db68-4958-a7ed-522865e3724c 0135-0150 HUMAN OTC DRUG PANADOL PM acetaminophen and diphenhydramine HCl TABLET, FILM COATED ORAL 20110323 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare LP ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 0135-0154_1bdfbc91-a562-4518-947d-0393f5808589 0135-0154 HUMAN OTC DRUG TUMS EX calcium carbonate TABLET ORAL 20100118 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 750 mg/1 0135-0157_75592985-844a-4262-8407-51301501e5cc 0135-0157 HUMAN OTC DRUG Nicorette Original nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA018612 GlaxoSmithKline Consumer Healthcare LP NICOTINE 2 mg/1 0135-0158_75592985-844a-4262-8407-51301501e5cc 0135-0158 HUMAN OTC DRUG Nicorette Original nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA020066 GlaxoSmithKline Consumer Healthcare LP NICOTINE 4 mg/1 0135-0178_1bdfbc91-a562-4518-947d-0393f5808589 0135-0178 HUMAN OTC DRUG TUMS EX calcium carbonate TABLET ORAL 20100118 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 750 mg/1 0135-0179_ff5698a8-0609-4459-826e-6f449b9b28a3 0135-0179 HUMAN OTC DRUG AQUAFRESH TARTAR CONTROL WHITENING sodium fluoride PASTE DENTAL 20110325 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.1 mg/g 0135-0180_3ef5baf0-693c-4a5c-a886-a615f49fe9b1 0135-0180 HUMAN OTC DRUG TUMS ULTRA calcium carbonate TABLET, CHEWABLE ORAL 20100212 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 1000 mg/1 0135-0181_3ef5baf0-693c-4a5c-a886-a615f49fe9b1 0135-0181 HUMAN OTC DRUG TUMS ULTRA calcium carbonate TABLET, CHEWABLE ORAL 20100212 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 1000 mg/1 0135-0194_f1b0b6f7-678c-4128-be62-bdcf889437f6 0135-0194 HUMAN OTC DRUG NICODERM CQ nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20110512 NDA NDA020165 GlaxoSmithKline Consumer Healthcare LP NICOTINE 21 mg/24h 0135-0195_f1b0b6f7-678c-4128-be62-bdcf889437f6 0135-0195 HUMAN OTC DRUG NICODERM CQ nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20110512 NDA NDA020165 GlaxoSmithKline Consumer Healthcare LP NICOTINE 14 mg/24h 0135-0196_f1b0b6f7-678c-4128-be62-bdcf889437f6 0135-0196 HUMAN OTC DRUG NICODERM CQ nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20110512 NDA NDA020165 GlaxoSmithKline Consumer Healthcare LP NICOTINE 7 mg/24h 0135-0199_f64029c6-e697-4e6b-a69e-47e004cd6f73 0135-0199 HUMAN OTC DRUG CITRUCEL methylcellulose TABLET ORAL 20100201 OTC MONOGRAPH NOT FINAL part334 GlaxoSmithKline Consumer Healthcare LP METHYLCELLULOSE (4000 MPA.S) 500 mg/1 0135-0200_48959395-8cf5-471d-928e-b2dc25d4c23b 0135-0200 HUMAN OTC DRUG ABREVA docosanol CREAM TOPICAL 20100319 NDA NDA020941 GlaxoSmithKline Consumer Healthcare LP DOCOSANOL 100 mg/g 0135-0201_ff5698a8-0609-4459-826e-6f449b9b28a3 0135-0201 HUMAN OTC DRUG AQUAFRESH ULTIMATE WHITE sodium fluoride PASTE DENTAL 20110325 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.1 mg/g 0135-0225_75592985-844a-4262-8407-51301501e5cc 0135-0225 HUMAN OTC DRUG Nicorette Fresh Mint nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA018612 GlaxoSmithKline Consumer Healthcare LP NICOTINE 2 mg/1 0135-0226_75592985-844a-4262-8407-51301501e5cc 0135-0226 HUMAN OTC DRUG Nicorette Fresh Mint nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA020066 GlaxoSmithKline Consumer Healthcare LP NICOTINE 4 mg/1 0135-0228_3ef5baf0-693c-4a5c-a886-a615f49fe9b1 0135-0228 HUMAN OTC DRUG TUMS ULTRA calcium carbonate TABLET, CHEWABLE ORAL 20100212 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 1000 mg/1 0135-0229_75592985-844a-4262-8407-51301501e5cc 0135-0229 HUMAN OTC DRUG Nicorette Mint nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA018612 GlaxoSmithKline Consumer Healthcare LP NICOTINE 2 mg/1 0135-0230_75592985-844a-4262-8407-51301501e5cc 0135-0230 HUMAN OTC DRUG Nicorette Mint nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA020066 GlaxoSmithKline Consumer Healthcare LP NICOTINE 4 mg/1 0135-0234_ff5698a8-0609-4459-826e-6f449b9b28a3 0135-0234 HUMAN OTC DRUG AQUAFRESH EXTREME CLEAN WHITENING ACTION sodium fluoride PASTE DENTAL 20110325 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.13 mg/g 0135-0239_8f1f85f4-31fe-4ff6-9e7e-57f05cc7b3d9 0135-0239 HUMAN OTC DRUG PANADOL Extra Strength acetaminophen TABLET, FILM COATED ORAL 20110318 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healtcare LP ACETAMINOPHEN 500 mg/1 0135-0241_a20eba39-a394-4596-aede-aeac1c4d1e8a 0135-0241 HUMAN OTC DRUG Nicorette Fruit Chill nicotine polacrilex GUM, CHEWING ORAL 20090914 NDA NDA018612 GlaxoSmithKline Consumer Healthcare LP NICOTINE 2 mg/1 0135-0242_a20eba39-a394-4596-aede-aeac1c4d1e8a 0135-0242 HUMAN OTC DRUG Nicorette Fruit Chill nicotine polacrilex GUM, CHEWING ORAL 20090914 NDA NDA020066 GlaxoSmithKline Consumer Healthcare LP NICOTINE 4 mg/1 0135-0243_3cf13eae-aee0-496c-b404-b094fc4905a5 0135-0243 HUMAN OTC DRUG TUMS Smoothies calcium carbonate TABLET, CHEWABLE ORAL 20100324 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 750 mg/1 0135-0245_3cf13eae-aee0-496c-b404-b094fc4905a5 0135-0245 HUMAN OTC DRUG TUMS Smoothies calcium carbonate TABLET, CHEWABLE ORAL 20100324 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 750 mg/1 0135-0246_3cf13eae-aee0-496c-b404-b094fc4905a5 0135-0246 HUMAN OTC DRUG TUMS Smoothies calcium carbonate TABLET, CHEWABLE ORAL 20100324 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 750 mg/1 0135-0429_bbf3b915-f680-4cd7-83dd-335033ccd9e7 0135-0429 HUMAN OTC DRUG PHAZYME simethicone CAPSULE, GELATIN COATED ORAL 20110504 20150930 OTC MONOGRAPH FINAL part332 GlaxoSmithKline Consumer Healthcare LP DIMETHICONE 410 180 mg/1 0135-0430_d719eb56-6ed3-444e-ba3c-c4ab07dd8492 0135-0430 HUMAN OTC DRUG Gaviscon Extra Strength aluminum hydroxide and magnesium carbonate TABLET, CHEWABLE ORAL 20110613 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare LP ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 0135-0432_ff5698a8-0609-4459-826e-6f449b9b28a3 0135-0432 HUMAN OTC DRUG AQUAFRESH EXTREME CLEAN DEEP ACTION sodium fluoride PASTE DENTAL 20110325 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.13 mg/g 0135-0433_302b9031-b45d-4f2b-acd6-cbbc612cdfe8 0135-0433 HUMAN OTC DRUG Panadol acetaminophen TABLET, FILM COATED ORAL 20110422 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare LP ACETAMINOPHEN 500 mg/1 0135-0435_ff5698a8-0609-4459-826e-6f449b9b28a3 0135-0435 HUMAN OTC DRUG AQUAFRESH EXTREME CLEAN FRESHENING ACTION sodium fluoride PASTE DENTAL 20110325 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.13 mg/g 0135-0456_3cf13eae-aee0-496c-b404-b094fc4905a5 0135-0456 HUMAN OTC DRUG TUMS Smoothies calcium carbonate TABLET, CHEWABLE ORAL 20100324 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 750 mg/1 0135-0459_5a467b39-2f4b-4eb2-bc04-2e882616b0a3 0135-0459 HUMAN OTC DRUG Panadol Cold and Flu NonDrowsy acetaminophen and phenylephrine HCl TABLET, FILM COATED ORAL 20110831 OTC MONOGRAPH FINAL part341 GlaxoSmithKline Consumer Healthcare LP ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 0135-0460_732a63ee-452b-48da-9653-abfd4f8edf5c 0135-0460 HUMAN OTC DRUG SENSODYNE PRONAMEL potassium nitrate and sodium fluoride PASTE ORAL 20101018 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 0135-0461_e86c34ef-9a81-4a31-90d9-23a4a547eca3 0135-0461 HUMAN OTC DRUG ALLI orlistat CAPSULE ORAL 20070207 NDA NDA021887 GlaxoSmithKline Consumer Healthcare LP ORLISTAT 60 mg/1 0135-0466_75592985-844a-4262-8407-51301501e5cc 0135-0466 HUMAN OTC DRUG Nicorette Cinnamon Surge nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA018612 GlaxoSmithKline Consumer Healthcare LP NICOTINE 2 mg/1 0135-0467_75592985-844a-4262-8407-51301501e5cc 0135-0467 HUMAN OTC DRUG Nicorette Cinnamon Surge nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA020066 GlaxoSmithKline Consumer Healthcare LP NICOTINE 4 mg/1 0135-0468_ff5698a8-0609-4459-826e-6f449b9b28a3 0135-0468 HUMAN OTC DRUG AQUAFRESH ADVANCED 2X ENAMEL sodium fluoride PASTE DENTAL 20110325 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.15 mg/g 0135-0469_128ae103-6d51-4b03-9481-6a2a9b57d987 0135-0469 HUMAN OTC DRUG TUMS calcium carbonate TABLET, CHEWABLE ORAL 20100407 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 750 mg/1 0135-0473_ff5698a8-0609-4459-826e-6f449b9b28a3 0135-0473 HUMAN OTC DRUG AQUAFRESH ADVANCED 2X WHITENING sodium fluoride PASTE DENTAL 20110325 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.1 mg/g 0135-0474_75592985-844a-4262-8407-51301501e5cc 0135-0474 HUMAN OTC DRUG Nicorette White Ice Mint nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA018612 GlaxoSmithKline Consumer Healthcare LP NICOTINE 2 mg/1 0135-0475_75592985-844a-4262-8407-51301501e5cc 0135-0475 HUMAN OTC DRUG Nicorette White Ice Mint nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA020066 GlaxoSmithKline Consumer Healthcare LP NICOTINE 4 mg/1 0135-0484_732a63ee-452b-48da-9653-abfd4f8edf5c 0135-0484 HUMAN OTC DRUG SENSODYNE PRONAMEL potassium nitrate and sodium fluoride PASTE ORAL 20101018 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 0135-0485_0fd1ca4f-5a9b-474b-a3b9-3f95990507bb 0135-0485 HUMAN OTC DRUG SENSODYNE PRONAMEL sodium fluoride PASTE ORAL 20101018 20160617 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.5 mg/g 0135-0487_048e9d43-2854-4c42-bf4a-797e2e589a70 0135-0487 HUMAN OTC DRUG BIOTENE Fresh Mint Original sodium monofluorophosphate PASTE ORAL 20110418 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g 0135-0488_048e9d43-2854-4c42-bf4a-797e2e589a70 0135-0488 HUMAN OTC DRUG BIOTENE Gentle Mint sodium monofluorophosphate GEL ORAL 20110418 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g 0135-0490_048e9d43-2854-4c42-bf4a-797e2e589a70 0135-0490 HUMAN OTC DRUG BIOTENE sodium monofluorophosphate PASTE ORAL 20110418 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g 0135-0502_01281fed-6bd3-4baa-8bdc-f1bf182507fa 0135-0502 HUMAN OTC DRUG SENSODYNE iso-active potassium nitrate and sodium fluoride GEL DENTAL 20090901 20161231 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 0135-0503_01281fed-6bd3-4baa-8bdc-f1bf182507fa 0135-0503 HUMAN OTC DRUG SENSODYNE iso-active potassium nitrate and sodium fluoride GEL DENTAL 20090901 20160831 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 0135-0504_b539fc3b-61c7-40f4-81d6-0a447e617626 0135-0504 HUMAN OTC DRUG AQUAFRESH iso-active sodium fluoride GEL DENTAL 20090901 20150131 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.5 mg/g 0135-0505_b539fc3b-61c7-40f4-81d6-0a447e617626 0135-0505 HUMAN OTC DRUG AQUAFRESH iso-active sodium fluoride GEL DENTAL 20090901 20150131 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.5 mg/g 0135-0507_5b67183a-0c9d-4d6c-902f-4fe425e3e439 0135-0507 HUMAN OTC DRUG Panadol acetaminophen TABLET, FILM COATED ORAL 20110621 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare LP ACETAMINOPHEN 500 mg/1 0135-0508_5194d86d-0c93-42b9-8670-8b06d3362665 0135-0508 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20100301 NDA NDA022360 GlaxoSmithKline Consumer Healthcare LP NICOTINE 2 mg/1 0135-0509_5194d86d-0c93-42b9-8670-8b06d3362665 0135-0509 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20100301 NDA NDA022360 GlaxoSmithKline Consumer Healthcare LP NICOTINE 4 mg/1 0135-0510_1d217011-80ed-4f10-ae93-54c424ed200b 0135-0510 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20101019 NDA NDA021330 GlaxoSmithKline Consumer Healthcare LP NICOTINE 2 mg/1 0135-0511_1d217011-80ed-4f10-ae93-54c424ed200b 0135-0511 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20101019 NDA NDA021330 GlaxoSmithKline Consumer Healthcare LP NICOTINE 4 mg/1 0135-0512_1d217011-80ed-4f10-ae93-54c424ed200b 0135-0512 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20101019 NDA NDA021330 GlaxoSmithKline Consumer Healthcare LP NICOTINE 2 mg/1 0135-0513_1d217011-80ed-4f10-ae93-54c424ed200b 0135-0513 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20101019 NDA NDA021330 GlaxoSmithKline Consumer Healthcare LP NICOTINE 4 mg/1 0135-0514_1d217011-80ed-4f10-ae93-54c424ed200b 0135-0514 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20101019 NDA NDA021330 GlaxoSmithKline Consumer Healthcare LP NICOTINE 2 mg/1 0135-0515_1d217011-80ed-4f10-ae93-54c424ed200b 0135-0515 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20101019 NDA NDA021330 GlaxoSmithKline Consumer Healthcare LP NICOTINE 4 mg/1 0135-0518_49f573f6-300b-4c1a-9189-e1d3775b3935 0135-0518 HUMAN OTC DRUG SENSODYNE Pronamel iso-active potassium nitrate and sodium fluoride GEL DENTAL 20110614 20160331 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 0135-0519_49f573f6-300b-4c1a-9189-e1d3775b3935 0135-0519 HUMAN OTC DRUG SENSODYNE Pronamel iso-active potassium nitrate and sodium fluoride GEL DENTAL 20110614 20160930 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 0135-0520_732a63ee-452b-48da-9653-abfd4f8edf5c 0135-0520 HUMAN OTC DRUG SENSODYNE PRONAMEL potassium nitrate and sodium fluoride PASTE ORAL 20110414 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 0135-0521_1bdfbc91-a562-4518-947d-0393f5808589 0135-0521 HUMAN OTC DRUG TUMS EX calcium carbonate TABLET ORAL 20110323 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 750 mg/1 0135-0522_0667dda4-6843-4eb8-858c-100edaf8ee86 0135-0522 HUMAN OTC DRUG Tums freshers calcium carbonate TABLET, CHEWABLE ORAL 20120202 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare LP CALCIUM CARBONATE 500 mg/1 0135-0523_ff5698a8-0609-4459-826e-6f449b9b28a3 0135-0523 HUMAN OTC DRUG AQUAFRESH PURE BREATH ACTION sodium fluoride PASTE DENTAL 20110325 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.15 mg/g 0135-0524_b539fc3b-61c7-40f4-81d6-0a447e617626 0135-0524 HUMAN OTC DRUG AQUAFRESH iso-active sodium fluoride GEL DENTAL 20110718 20150930 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.5 mg/g 0135-0525_4a434fe7-ff53-43fe-a943-cd1039ed916f 0135-0525 HUMAN OTC DRUG Sensodyne Extra Whitening potassium nitrate and sodium fluoride PASTE DENTAL 19900930 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 0135-0526_4a434fe7-ff53-43fe-a943-cd1039ed916f 0135-0526 HUMAN OTC DRUG Sensodyne Original Flavor potassium nitrate and sodium fluoride PASTE DENTAL 19900930 20160630 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.3 mg/g; mg/g 0135-0527_4a434fe7-ff53-43fe-a943-cd1039ed916f 0135-0527 HUMAN OTC DRUG Sensodyne CoolGel potassium nitrate and sodium fluoride GEL DENTAL 19900930 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 0135-0528_4a434fe7-ff53-43fe-a943-cd1039ed916f 0135-0528 HUMAN OTC DRUG Sensodyne Fresh Impact potassium nitrate and sodium fluoride PASTE DENTAL 20000701 20160630 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 0135-0529_4a434fe7-ff53-43fe-a943-cd1039ed916f 0135-0529 HUMAN OTC DRUG Sensodyne Fresh Mint potassium nitrate and sodium fluoride PASTE DENTAL 19900930 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 0135-0530_ff5698a8-0609-4459-826e-6f449b9b28a3 0135-0530 HUMAN OTC DRUG AQUAFRESH EXTREME CLEAN REVITALIZING ACTION sodium fluoride PASTE DENTAL 20110907 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.13 mg/g 0135-0531_fa955d47-ec1d-435c-afad-174087152b75 0135-0531 HUMAN OTC DRUG Aquafresh Extra Fresh Whitening sodium monofluorophosphate PASTE DENTAL 20120216 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g 0135-0532_75592985-844a-4262-8407-51301501e5cc 0135-0532 HUMAN OTC DRUG Nicorette Spearmint Burst nicotine polacrilex GUM, CHEWING ORAL 20111115 NDA NDA018612 GlaxoSmithKline Consumer Healthcare LP NICOTINE 2 mg/1 0135-0533_75592985-844a-4262-8407-51301501e5cc 0135-0533 HUMAN OTC DRUG Nicorette Spearmint Burst nicotine polacrilex GUM, CHEWING ORAL 20111115 NDA NDA020066 GlaxoSmithKline Consumer Healthcare LP NICOTINE 4 mg/1 0135-0534_7b876188-e7f4-455d-8597-242f4050e5cc 0135-0534 HUMAN OTC DRUG Aquafresh fresh n fruity sodium monofluorophosphate PASTE DENTAL 20120309 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM MONOFLUOROPHOSPHATE 1.1 mg/g 0135-0537_65e86601-b43b-4714-922f-d1b8c0822051 0135-0537 HUMAN OTC DRUG PANADOL acetaminophen SUSPENSION ORAL 20121015 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare LP ACETAMINOPHEN 160 mg/5mL 0135-0539_4a9a8fed-c098-4741-ae40-7aec5e50349b 0135-0539 HUMAN OTC DRUG PANADOL acetaminophen SUSPENSION ORAL 20121015 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare LP ACETAMINOPHEN 160 mg/5mL 0135-0540_3ef5baf0-693c-4a5c-a886-a615f49fe9b1 0135-0540 HUMAN OTC DRUG TUMS ULTRA calcium carbonate TABLET, CHEWABLE ORAL 20100212 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Heathcare LP CALCIUM CARBONATE 1000 mg/1 0135-0541_0667dda4-6843-4eb8-858c-100edaf8ee86 0135-0541 HUMAN OTC DRUG Tums freshers calcium carbonate TABLET, CHEWABLE ORAL 20130801 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare LP CALCIUM CARBONATE 500 mg/1 0135-0544_7117f6d0-ea46-4b64-a616-07f3a38db5f4 0135-0544 HUMAN OTC DRUG Aquafresh Big Kids sodium fluoride PASTE DENTAL 20140107 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.4 mg/g 0135-0547_05fb7866-4f02-4e56-8759-a6c6026ef192 0135-0547 HUMAN OTC DRUG SENSODYNE Repair and Protect Extra Fresh stannous fluoride PASTE ORAL 20130204 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP STANNOUS FLUORIDE 1.5 mg/g 0135-0548_05fb7866-4f02-4e56-8759-a6c6026ef192 0135-0548 HUMAN OTC DRUG SENSODYNE Repair and Protect stannous fluoride PASTE ORAL 20130204 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP STANNOUS FLUORIDE 1.5 mg/g 0135-0549_5369b3d2-b1f5-41ec-a34f-3a2d6a76034d 0135-0549 HUMAN OTC DRUG Sensodyne Pronamel Fluoride Rinse sodium fluoride MOUTHWASH ORAL 20130204 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE .2 mg/L 0135-0550_e4868fb1-83f2-416c-9779-c30aadd30011 0135-0550 HUMAN OTC DRUG Sensodyne potassium nitrate and sodium fluoride GEL DENTAL 20040217 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 0135-0551_e4868fb1-83f2-416c-9779-c30aadd30011 0135-0551 HUMAN OTC DRUG Sensodyne potassium nitrate and sodium fluoride GEL DENTAL 20020102 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 0135-0557_540acfba-e305-4242-babd-be02ccdeacae 0135-0557 HUMAN OTC DRUG BIOTENE Fresh Mint Original sodium fluoride PASTE ORAL 20130715 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.5 mg/g 0135-0558_540acfba-e305-4242-babd-be02ccdeacae 0135-0558 HUMAN OTC DRUG BIOTENE Gentle Mint sodium fluoride PASTE ORAL 20130715 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.5 mg/g 0135-0559_540acfba-e305-4242-babd-be02ccdeacae 0135-0559 HUMAN OTC DRUG BIOTENE PBF sodium fluoride PASTE ORAL 20130715 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.5 mg/g 0135-0560_cb250cbb-322a-4145-bbeb-eaf5aa8122de 0135-0560 HUMAN OTC DRUG Tums Chewy Delights calcium carbonate BAR, CHEWABLE ORAL 20130801 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare LP CALCIUM CARBONATE 1177 mg/1 0135-0561_cb250cbb-322a-4145-bbeb-eaf5aa8122de 0135-0561 HUMAN OTC DRUG Tums Chewy Delights calcium carbonate BAR, CHEWABLE ORAL 20130801 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare LP CALCIUM CARBONATE 1177 mg/1 0135-0563_ff5698a8-0609-4459-826e-6f449b9b28a3 0135-0563 HUMAN OTC DRUG AQUAFRESH CAVITY PROTECTION sodium fluoride PASTE DENTAL 20140509 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.13 mg/g 0135-0564_ff5698a8-0609-4459-826e-6f449b9b28a3 0135-0564 HUMAN OTC DRUG AQUAFRESH EXTRA FRESH PLUS WHITENING sodium fluoride PASTE DENTAL 20140509 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare LP SODIUM FLUORIDE 1.13 mg/g 0135-0568_732a63ee-452b-48da-9653-abfd4f8edf5c 0135-0568 HUMAN OTC DRUG SENSODYNE PRONAMEL potassium nitrate and sodium fluoride PASTE ORAL 20131209 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 0135-0569_cb250cbb-322a-4145-bbeb-eaf5aa8122de 0135-0569 HUMAN OTC DRUG Tums Chewy Delights calcium carbonate BAR, CHEWABLE ORAL 20140815 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare LP CALCIUM CARBONATE 1177 mg/1 0135-0572_e3cc3146-8aed-4f6b-a252-e379418c2b8d 0135-0572 HUMAN OTC DRUG Sensodyne Complete Protection Extra Fresh stannous fluoride PASTE DENTAL 20140714 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP STANNOUS FLUORIDE 1.5 mg/g 0135-0573_e3cc3146-8aed-4f6b-a252-e379418c2b8d 0135-0573 HUMAN OTC DRUG Sensodyne Complete Protection stannous fluoride PASTE DENTAL 20140714 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP STANNOUS FLUORIDE 1.5 mg/g 0135-0574_e89689fb-f0c5-49c6-a957-d378cd039742 0135-0574 HUMAN OTC DRUG GAVISCON aluminum hydroxide and magnesium carbonate LIQUID ORAL 20140801 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare LP ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 254; 237.5 mg/5mL; mg/5mL 0135-0576_9948737b-7fab-487d-a719-aa3133497ef2 0135-0576 HUMAN OTC DRUG FLONASE fluticasone propionate SPRAY, METERED NASAL 20141204 NDA NDA205434 GlaxoSmithKline Consumer Healthcare LP FLUTICASONE PROPIONATE 50 ug/1 0140-0004_ec58f27c-6437-4074-bcf5-0e47ab94e8d8 0140-0004 HUMAN PRESCRIPTION DRUG Valium diazepam TABLET ORAL 19631115 NDA NDA013263 Roche Products Inc DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0140-0005_ec58f27c-6437-4074-bcf5-0e47ab94e8d8 0140-0005 HUMAN PRESCRIPTION DRUG Valium diazepam TABLET ORAL 19631115 NDA NDA013263 Roche Products Inc DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0140-0006_ec58f27c-6437-4074-bcf5-0e47ab94e8d8 0140-0006 HUMAN PRESCRIPTION DRUG Valium diazepam TABLET ORAL 19631115 NDA NDA013263 Roche Products Inc DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0143-0170_d7673793-e24d-42ec-a984-2e73992fa8aa 0143-0170 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine CAPSULE ORAL 19981028 ANDA ANDA040261 West-Ward Pharmaceutical Corp ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0143-1020_a9a6a798-1030-4fd5-ac2d-fdd4c0ed7656 0143-1020 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline dihydrate TABLET ORAL 19751126 ANDA ANDA084540 West-ward Pharmaceutical Corp AMINOPHYLLINE DIHYDRATE 100 mg/1 0143-1025_a9a6a798-1030-4fd5-ac2d-fdd4c0ed7656 0143-1025 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline dihydrate TABLET ORAL 19760528 ANDA ANDA085003 West-ward Pharmaceutical Corp AMINOPHYLLINE DIHYDRATE 200 mg/1 0143-1115_92c69ec9-fe47-4d4c-8812-5eeea3e43504 0143-1115 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 19990818 ANDA ANDA040336 West-Ward Pharmaceutical Corp ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0143-1171_a60779b8-349e-4d09-ad34-4da386887950 0143-1171 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 West-Ward Pharmaceutical Corp CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-1172_a60779b8-349e-4d09-ad34-4da386887950 0143-1172 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 West-Ward Pharmaceutical Corp CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-1173_a60779b8-349e-4d09-ad34-4da386887950 0143-1173 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 West-Ward Pharmaceutical Corp CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-1174_a60779b8-349e-4d09-ad34-4da386887950 0143-1174 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 West-Ward Pharmaceutical Corp CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-1176_589dd668-06d7-41d9-9136-f1951bce2f7f 0143-1176 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19960124 ANDA ANDA040124 West-Ward Pharmaceutical Corp CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 0143-1195_6c3b6cb9-0270-4ce5-aa51-fc8834f39880 0143-1195 HUMAN PRESCRIPTION DRUG Chloroquine Chloroquine Phosphate TABLET ORAL 19750709 ANDA ANDA083082 West-ward Pharmaceutical Corp CHLOROQUINE PHOSPHATE 250 mg/1 Antimalarial [EPC] 0143-1202_81505329-962c-4f65-ab24-f64007740e32 0143-1202 HUMAN PRESCRIPTION DRUG Cortisone Acetate Cortisone Acetate TABLET ORAL 19720613 ANDA ANDA080776 West-ward Pharmaceutical Corp CORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0143-1209_2af0405e-71c2-4074-bbd2-41ef19697dd0 0143-1209 HUMAN PRESCRIPTION DRUG Chlorothiazide Chlorothiazide TABLET ORAL 20050830 ANDA ANDA086028 West-ward Pharmaceutical Corp CHLOROTHIAZIDE 250 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0143-1210_2af0405e-71c2-4074-bbd2-41ef19697dd0 0143-1210 HUMAN PRESCRIPTION DRUG Chlorothiazide Chlorothiazide TABLET ORAL 20050830 ANDA ANDA087736 West-ward Pharmaceutical Corp CHLOROTHIAZIDE 500 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0143-1227_ad8d8eca-e680-459b-81cb-84b58548f5d3 0143-1227 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 West-ward Pharmaceutical Corp DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0143-1240_380631ab-1138-42d9-8122-17fcc0ccab99 0143-1240 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 West-Ward Pharmaceutical Corp DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0143-1241_380631ab-1138-42d9-8122-17fcc0ccab99 0143-1241 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 West-Ward Pharmaceutical Corp DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0143-1246_18cc54af-63ba-47f7-a805-66b2da1f522e 0143-1246 HUMAN PRESCRIPTION DRUG Fludrocortisone Acetate Fludrocortisone Acetate TABLET ORAL 20110722 ANDA ANDA091302 West-ward Pharmaceutical Corp FLUDROCORTISONE ACETATE .1 mg/1 0143-1250_6ce73874-823f-4018-9a79-98c99897a2ec 0143-1250 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20090305 ANDA ANDA040836 West-ward Pharmaceutical Corp GLYCOPYRROLATE 1 mg/1 0143-1251_6ce73874-823f-4018-9a79-98c99897a2ec 0143-1251 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20090305 ANDA ANDA040836 West-ward Pharmaceutical Corp GLYCOPYRROLATE 2 mg/1 0143-1254_c30a36b6-e06a-4bf0-b3cb-bfdd2ffb7b29 0143-1254 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 19730618 ANDA ANDA083365 West-Ward Pharmaceutical Corp HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0143-1256_41215fb1-eeae-491d-99b7-766303842823 0143-1256 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20060801 ANDA ANDA084878 West-ward Pharmaceutical Corp HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0143-1257_41215fb1-eeae-491d-99b7-766303842823 0143-1257 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19770201 ANDA ANDA084878 West-ward Pharmaceutical Corp HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0143-1260_16b86d9e-9f7d-4267-b8f8-73944f57f6ad 0143-1260 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720228 ANDA ANDA080212 West-Ward Pharmaceutical Corp ISONIAZID 100 mg/1 Antimycobacterial [EPC] 0143-1261_16b86d9e-9f7d-4267-b8f8-73944f57f6ad 0143-1261 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19810714 ANDA ANDA087425 West-Ward Pharmaceutical Corp ISONIAZID 300 mg/1 Antimycobacterial [EPC] 0143-1262_d8d5470d-10cc-4485-97e8-1bfe16ecb62b 0143-1262 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 West-Ward Pharmaceutical Corp HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-1263_d8d5470d-10cc-4485-97e8-1bfe16ecb62b 0143-1263 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 West-Ward Pharmaceutical Corp HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-1264_d8d5470d-10cc-4485-97e8-1bfe16ecb62b 0143-1264 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 West-Ward Pharmaceutical Corp HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-1265_4bfecf84-f1d6-46f8-8fa9-e8242b4a954d 0143-1265 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 West-Ward Pharmaceutical Corp LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-1266_4bfecf84-f1d6-46f8-8fa9-e8242b4a954d 0143-1266 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 West-Ward Pharmaceutical Corp LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-1267_4bfecf84-f1d6-46f8-8fa9-e8242b4a954d 0143-1267 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 West-Ward Pharmaceutical Corp LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-1268_4bfecf84-f1d6-46f8-8fa9-e8242b4a954d 0143-1268 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 West-Ward Pharmaceutical Corp LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-1270_4bfecf84-f1d6-46f8-8fa9-e8242b4a954d 0143-1270 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 West-Ward Pharmaceutical Corp LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-1277_760bee09-05a4-4a0d-bff8-4cc2540575ad 0143-1277 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20020906 ANDA ANDA076490 West-Ward Pharmaceutical Corp LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] 0143-1280_4bfecf84-f1d6-46f8-8fa9-e8242b4a954d 0143-1280 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 West-Ward Pharmaceutical Corp LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-1282_cd11964d-780c-4e52-8ec0-a81a2572b817 0143-1282 HUMAN PRESCRIPTION DRUG Mefloquine Hydrochloride Mefloquine Hydrochloride TABLET ORAL 20100421 ANDA ANDA077699 West-ward Pharmaceutical Corp MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC] 0143-1290_819014fe-9ff1-448d-9b67-58027f114582 0143-1290 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 West-Ward Pharmaceutical Corp METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0143-1292_819014fe-9ff1-448d-9b67-58027f114582 0143-1292 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 West-Ward Pharmaceutical Corp METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0143-1300_f27a8c61-3d94-4e67-ade6-7602badc6e0a 0143-1300 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET ORAL 20101228 ANDA ANDA078715 West-Ward Pharmaceutical Corp LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 0143-1333_68b9d139-fbb3-44f1-9933-96598c04dd56 0143-1333 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, COATED ORAL 20001005 ANDA ANDA075361 West-ward Pharmaceutical Corp ISOSORBIDE MONONITRATE 20 mg/1 0143-1346_aee23550-e529-43f8-a57d-eb6178207564 0143-1346 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040114 ANDA ANDA076494 West-ward Pharmaceutical Corp NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0143-1347_aee23550-e529-43f8-a57d-eb6178207564 0143-1347 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040114 ANDA ANDA076494 West-ward Pharmaceutical Corp NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0143-1348_aee23550-e529-43f8-a57d-eb6178207564 0143-1348 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040114 ANDA ANDA076494 West-ward Pharmaceutical Corp NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0143-1410_e6cb8609-d890-4f1a-a740-e4ec301ce43e 0143-1410 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20101101 ANDA ANDA040890 West-Ward Pharmaceutical Corp PREDNISONE 1 mg/1 0143-1425_e6cb8609-d890-4f1a-a740-e4ec301ce43e 0143-1425 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20040108 ANDA ANDA040538 West-Ward Pharmaceutical Corp PREDNISONE 2.5 mg/1 0143-1445_e5cbcb00-9f70-4552-94e2-5f8a36832548 0143-1445 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120301 UNAPPROVED DRUG OTHER West-Ward Pharmaceutical Corp PHENOBARBITAL 15 mg/1 CIV 0143-1450_e5cbcb00-9f70-4552-94e2-5f8a36832548 0143-1450 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120301 UNAPPROVED DRUG OTHER West-Ward Pharmaceutical Corp PHENOBARBITAL 30 mg/1 CIV 0143-1455_e5cbcb00-9f70-4552-94e2-5f8a36832548 0143-1455 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120301 UNAPPROVED DRUG OTHER West-Ward Pharmaceutical Corp PHENOBARBITAL 60 mg/1 CIV 0143-1458_e5cbcb00-9f70-4552-94e2-5f8a36832548 0143-1458 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120301 UNAPPROVED DRUG OTHER West-Ward Pharmaceutical Corp PHENOBARBITAL 100 mg/1 CIV 0143-1473_e6cb8609-d890-4f1a-a740-e4ec301ce43e 0143-1473 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19851204 ANDA ANDA088832 West-Ward Pharmaceutical Corp PREDNISONE 10 mg/1 0143-1475_e6cb8609-d890-4f1a-a740-e4ec301ce43e 0143-1475 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19720522 ANDA ANDA080292 West-Ward Pharmaceutical Corp PREDNISONE 5 mg/1 0143-1477_e6cb8609-d890-4f1a-a740-e4ec301ce43e 0143-1477 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19740226 ANDA ANDA083677 West-Ward Pharmaceutical Corp PREDNISONE 20 mg/1 0143-1480_7a31f17a-308c-45c5-b0d2-7a825de2a619 0143-1480 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 19710723 ANDA ANDA080154 West-Ward Pharmaceutical Corp PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 0143-1482_7d2a9a3b-a440-422e-afa1-7a4d41c2226a 0143-1482 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20060701 ANDA ANDA040667 West-ward Pharmaceutical Corp PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0143-1484_7d2a9a3b-a440-422e-afa1-7a4d41c2226a 0143-1484 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20060701 ANDA ANDA040667 West-ward Pharmaceutical Corp PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0143-1763_eb5e1442-b994-478a-8f26-64cbfbd06eb5 0143-1763 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20000216 ANDA ANDA040337 West-ward Pharmaceutical Corp TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 0143-1764_eb5e1442-b994-478a-8f26-64cbfbd06eb5 0143-1764 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20000216 ANDA ANDA040337 West-ward Pharmaceutical Corp TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 0143-1765_b7c4af42-2c43-4c96-8c33-3711f10cb904 0143-1765 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET SUBLINGUAL 19781201 ANDA ANDA086054 West-ward Pharmaceutical Corp ISOSORBIDE DINITRATE 2.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0143-1767_b7c4af42-2c43-4c96-8c33-3711f10cb904 0143-1767 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET SUBLINGUAL 19781201 ANDA ANDA086055 West-ward Pharmaceutical Corp ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0143-1769_2c781223-5054-47c4-9fed-eeeb1dcc0e1e 0143-1769 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086067 West-Ward Pharmaceutical Corp ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0143-1771_2c781223-5054-47c4-9fed-eeeb1dcc0e1e 0143-1771 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086066 West-Ward Pharmaceutical Corp ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0143-1772_2c781223-5054-47c4-9fed-eeeb1dcc0e1e 0143-1772 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19830426 ANDA ANDA088088 West-Ward Pharmaceutical Corp ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0143-1773_1bf5a3aa-3342-429a-8bd2-1d16550ba5c7 0143-1773 HUMAN PRESCRIPTION DRUG Isosorrbide Dinitrate Isosorbdie Dinitrate TABLET ORAL 20070110 ANDA ANDA040591 West-ward Pharmaceutical Corp ISOSORBIDE DINITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0143-1785_576e3e85-d465-4c0f-9d8a-3a786e2becd2 0143-1785 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine TABLET ORAL 19790605 ANDA ANDA086162 West-ward Pharmaceutical Corp ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 0143-1787_a260a0bc-9b3e-4e23-a062-896874956434 0143-1787 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 19950612 ANDA ANDA089718 West-Ward Pharmaceutical Corp ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0143-2037_037e496d-acee-497d-b039-e37c3d293e4f 0143-2037 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 West-ward Pharmaceutical Corp CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0143-2112_cdc84c89-abd2-41b3-a947-20abbada74f7 0143-2112 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 West-Ward Pharmaceutical Corp DOXYCYCLINE HYCLATE 100 mg/1 0143-2120_2dd70d46-765d-434d-92e6-4f8974dc31af 0143-2120 HUMAN PRESCRIPTION DRUG ERGOTAMINE ergotamine tartrate and caffeine TABLET, FILM COATED ORAL 20040917 ANDA ANDA040510 West-Ward Pharmaceutical Corp CAFFEINE; ERGOTAMINE TARTRATE 100; 1 mg/1; mg/1 Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0143-2125_6c3b6cb9-0270-4ce5-aa51-fc8834f39880 0143-2125 HUMAN PRESCRIPTION DRUG Chloroquine Chloroquine Phosphate TABLET, COATED ORAL 19990917 ANDA ANDA083082 West-ward Pharmaceutical Corp CHLOROQUINE PHOSPHATE 500 mg/1 Antimalarial [EPC] 0143-2128_a631870d-2d3d-4ade-a23f-23d9a8a22f45 0143-2128 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20070815 ANDA ANDA040760 West-ward Pharmaceutical Corp HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 0143-2230_1aca0362-3bb0-41d7-890f-5c6c6b208253 0143-2230 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060330 ANDA ANDA076813 West-Ward Pharmaceutical Corp ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0143-2260_1aca0362-3bb0-41d7-890f-5c6c6b208253 0143-2260 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060330 ANDA ANDA076813 West-Ward Pharmaceutical Corp ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0143-2422_ebd1e2c0-535e-4fd7-b679-177e91e68687 0143-2422 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron hydrochloride TABLET ORAL 20080101 ANDA ANDA077545 West-ward Pharmaceutical Corp ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0143-2423_ebd1e2c0-535e-4fd7-b679-177e91e68687 0143-2423 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron hydrochloride TABLET ORAL 20080101 ANDA ANDA077545 West-ward Pharmaceutical Corp ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0143-2424_ebd1e2c0-535e-4fd7-b679-177e91e68687 0143-2424 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET ORAL 20080101 ANDA ANDA077545 West-ward Pharmaceutical Corp ONDANSETRON HYDROCHLORIDE 24 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0143-3000_e2b0eec4-07d0-44a6-a1e9-be021c3cd1aa 0143-3000 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine with Codeine Phosphate Butalbital, Acetaminophen, Caffeine and Codeine Phosphate CAPSULE ORAL 20010321 ANDA ANDA075618 West-Ward Pharmaceutical Corp ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0143-3018_491e0ab1-f4be-44c8-a42b-338e2f61e40e 0143-3018 HUMAN PRESCRIPTION DRUG Colchicine Colchicine CAPSULE ORAL 20141001 NDA NDA204820 West-Ward Pharmaceutical Corp COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 0143-3125_e77821f2-101f-4189-873c-ed9065083bb9 0143-3125 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20071126 ANDA ANDA077885 West-ward Pharmaceutical Corp HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0143-3126_ad8d8eca-e680-459b-81cb-84b58548f5d3 0143-3126 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19970228 ANDA ANDA040204 West-ward Pharmaceutical Corp DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0143-3141_dcc372ab-9104-44f7-9f6e-8d1bfa7c415e 0143-3141 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19841107 ANDA ANDA062396 West-Ward Pharmaceutical Corp DOXYCYCLINE HYCLATE 50 mg/1 0143-3142_dcc372ab-9104-44f7-9f6e-8d1bfa7c415e 0143-3142 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19840507 ANDA ANDA062396 West-Ward Pharmaceutical Corp DOXYCYCLINE HYCLATE 100 mg/1 0143-3145_136d6fb7-9453-4b03-bcb6-6bb1152fdcc3 0143-3145 HUMAN OTC DRUG Ephedrine Sulfate Ephedrine Sulfate CAPSULE ORAL 19930901 OTC MONOGRAPH FINAL part310.533 West-ward Pharmaceutical Corp EPHEDRINE SULFATE 25 mg/1 0143-3188_1b7af486-c64d-439c-84ca-e13db5375448 0143-3188 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20030301 ANDA ANDA076243 West-Ward Pharmaceutical Corp LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] 0143-3189_1b7af486-c64d-439c-84ca-e13db5375448 0143-3189 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20030301 ANDA ANDA076243 West-Ward Pharmaceutical Corp LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 0143-3190_1b7af486-c64d-439c-84ca-e13db5375448 0143-3190 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20020501 ANDA ANDA078763 West-Ward Pharmaceutical Corp LITHIUM CARBONATE 600 mg/1 Mood Stabilizer [EPC] 0143-3367_3897b6f0-5a9e-4ea1-8f4e-c8cc47547d19 0143-3367 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 19861208 ANDA ANDA077107 West-ward Pharmaceutical Corp FLURAZEPAM HYDROCHLORIDE 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0143-3370_3897b6f0-5a9e-4ea1-8f4e-c8cc47547d19 0143-3370 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 19861208 ANDA ANDA071108 West-ward Pharmaceutical Corp FLURAZEPAM HYDROCHLORIDE 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0143-3991_164477b7-26bf-4c39-b2ac-d086ec30a07d 0143-3991 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 West-ward Pharmaceutical Corp GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0143-3993_164477b7-26bf-4c39-b2ac-d086ec30a07d 0143-3993 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 West-ward Pharmaceutical Corp GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0143-3994_164477b7-26bf-4c39-b2ac-d086ec30a07d 0143-3994 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 West-ward Pharmaceutical Corp GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0143-9130_75e775c1-b2da-4b93-9dd8-1903de92fcc8 0143-9130 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20060727 ANDA ANDA077836 West-ward Pharmaceutical Corp GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0143-9580_b301fcfc-fb14-46cc-ad49-56c5572c40ba 0143-9580 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090810 ANDA ANDA077864 West-ward Pharmaceutical Corp SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0143-9581_b301fcfc-fb14-46cc-ad49-56c5572c40ba 0143-9581 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090810 ANDA ANDA077864 West-ward Pharmaceutical Corp SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0143-9582_b301fcfc-fb14-46cc-ad49-56c5572c40ba 0143-9582 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090810 ANDA ANDA077864 West-ward Pharmaceutical Corp SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0143-9637_00675ece-38a0-4847-9d8e-ac53675caa71 0143-9637 HUMAN PRESCRIPTION DRUG Valproate Sodium Valproate Sodium INJECTION INTRAVENOUS 20130415 ANDA ANDA078523 West-Ward Pharmaceutical Corp VALPROATE SODIUM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0143-9638_ab23cb66-e2bd-4de6-8f75-91401f3c3258 0143-9638 HUMAN PRESCRIPTION DRUG SUMATRIPTAN sumatriptan succinate INJECTION SUBCUTANEOUS 20130916 ANDA ANDA200183 West-Ward Pharmaceutical Corp SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0143-9642_c872d8c8-6ea5-42f4-9020-dc920b26adf5 0143-9642 HUMAN PRESCRIPTION DRUG Zoledronic Acid zoledronic acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130603 ANDA ANDA202182 West-Ward Pharmaceutical Corp ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0143-9649_c53b5eef-2d4f-4143-a0ed-924ecfcd5552 0143-9649 HUMAN PRESCRIPTION DRUG MONTELUKAST MONTELUKAST TABLET, FILM COATED ORAL 20141201 ANDA ANDA202859 West ward Pharmaceutical Corp MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0143-9650_c53b5eef-2d4f-4143-a0ed-924ecfcd5552 0143-9650 HUMAN PRESCRIPTION DRUG MONTELUKAST MONTELUKAST TABLET, CHEWABLE ORAL 20141201 ANDA ANDA203037 West ward Pharmaceutical Corp MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0143-9651_c53b5eef-2d4f-4143-a0ed-924ecfcd5552 0143-9651 HUMAN PRESCRIPTION DRUG MONTELUKAST MONTELUKAST TABLET, CHEWABLE ORAL 20141201 ANDA ANDA203037 West ward Pharmaceutical Corp MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0143-9654_dc482e1f-d461-474e-96a4-ade47f9d3d1d 0143-9654 HUMAN PRESCRIPTION DRUG Sertraline sertraline hydrochloride TABLET, FILM COATED ORAL 20121106 ANDA ANDA077864 West-Ward Pharmaceutical Corp SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0143-9655_dc482e1f-d461-474e-96a4-ade47f9d3d1d 0143-9655 HUMAN PRESCRIPTION DRUG Sertraline sertraline hydrochloride TABLET, FILM COATED ORAL 20121106 ANDA ANDA077864 West-Ward Pharmaceutical Corp SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0143-9656_dc482e1f-d461-474e-96a4-ade47f9d3d1d 0143-9656 HUMAN PRESCRIPTION DRUG Sertraline sertraline hydrochloride TABLET, FILM COATED ORAL 20121106 ANDA ANDA077864 West-Ward Pharmaceutical Corp SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0143-9660_f0108f75-7b4e-4669-9b81-bee279fcb430 0143-9660 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoroprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 20070530 ANDA ANDA077761 West-Ward Pharmaceutical Corp METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0143-9665_bf84ea27-1c71-4bae-bf7a-b96b2d8734c5 0143-9665 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20041018 ANDA ANDA065143 West-Ward Pharmaceutical Corp CEFAZOLIN SODIUM 20 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9666_332a2f81-4e4a-4202-beec-64e2d13d794c 0143-9666 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20120130 ANDA ANDA078764 West-Ward Pharmaceutical Corp FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0143-9667_332a2f81-4e4a-4202-beec-64e2d13d794c 0143-9667 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20120130 ANDA ANDA078764 West-Ward Pharmaceutical Corp FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0143-9668_332a2f81-4e4a-4202-beec-64e2d13d794c 0143-9668 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20120130 ANDA ANDA078698 West-Ward Pharmaceutical Corp FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0143-9669_332a2f81-4e4a-4202-beec-64e2d13d794c 0143-9669 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20120130 ANDA ANDA078698 West-Ward Pharmaceutical Corp FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0143-9673_38906971-3a1b-4664-9e14-63aa4f4d2e4c 0143-9673 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION INTRAVENOUS 20111013 ANDA ANDA090981 West-Ward Pharmaceutical Corp LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0143-9674_e612f5c8-bf82-4962-bb4a-67409204ee65 0143-9674 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION INTRAVENOUS 20120105 NDA NDA203049 West-Ward Pharmaceutical Corp ARGATROBAN 250 mg/2.5mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] 0143-9679_e7ccc4ea-215d-4a99-8583-1a3198aecd5b 0143-9679 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20110921 ANDA ANDA090963 West-Ward Pharmaceutical Corp GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0143-9680_e7ccc4ea-215d-4a99-8583-1a3198aecd5b 0143-9680 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20110921 ANDA ANDA090963 West-Ward Pharmaceutical Corp GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0143-9681_e7ccc4ea-215d-4a99-8583-1a3198aecd5b 0143-9681 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20110921 ANDA ANDA090963 West-Ward Pharmaceutical Corp GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0143-9682_e7ccc4ea-215d-4a99-8583-1a3198aecd5b 0143-9682 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20110921 ANDA ANDA090963 West-Ward Pharmaceutical Corp GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0143-9683_55c7aded-d21a-4257-9daa-de4aaf4f95a6 0143-9683 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION, SOLUTION INTRAVENOUS 20090323 ANDA ANDA078527 West-Ward Pharmaceutical Corp FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 0143-9684_55c7aded-d21a-4257-9daa-de4aaf4f95a6 0143-9684 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION, SOLUTION INTRAVENOUS 20090323 ANDA ANDA078527 West-Ward Pharmaceutical Corp FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 0143-9689_76aaa20c-830a-4075-b32b-de6591ae6030 0143-9689 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION INTRAVENOUS 20120302 NDA NDA022276 West-ward Pharmaceutical Corp NICARDIPINE HYDROCHLORIDE 25 mg/10mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0143-9700_34ce92bc-6223-47ec-86e5-1810ced18047 0143-9700 HUMAN PRESCRIPTION DRUG Cortisone Acetate Cortisone Acetate TABLET ORAL 20130822 ANDA ANDA080776 West-Ward Pharmaceutical Corp CORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0143-9701_c2c36370-5318-4def-8476-2e961c430878 0143-9701 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION INTRAVENOUS 20101220 ANDA ANDA091032 West-Ward Pharmaceutical Corp IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0143-9702_c2c36370-5318-4def-8476-2e961c430878 0143-9702 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION INTRAVENOUS 20101220 ANDA ANDA091032 West-Ward Pharmaceutical Corp IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0143-9707_af7ceba6-da35-41f9-8207-5cfb1b4cea25 0143-9707 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20100816 ANDA ANDA078599 West-ward Pharmaceutical Corp GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0143-9708_f160bf47-1821-4ec0-b552-b16ee670b609 0143-9708 HUMAN PRESCRIPTION DRUG Milrinone Lactate Milrinone Lactate INJECTION, SOLUTION INTRAVENOUS 20101203 ANDA ANDA077966 West-ward Pharmaceutical Corp MILRINONE LACTATE 50 mg/50mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0143-9709_f160bf47-1821-4ec0-b552-b16ee670b609 0143-9709 HUMAN PRESCRIPTION DRUG Milrinone Lactate Milrinone Lactate INJECTION, SOLUTION INTRAVENOUS 20101203 ANDA ANDA077966 West-ward Pharmaceutical Corp MILRINONE LACTATE 20 mg/20mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0143-9710_f160bf47-1821-4ec0-b552-b16ee670b609 0143-9710 HUMAN PRESCRIPTION DRUG Milrinone Lactate Milrinone Lactate INJECTION, SOLUTION INTRAVENOUS 20101203 ANDA ANDA077966 West-ward Pharmaceutical Corp MILRINONE LACTATE 10 mg/10mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0143-9713_ca560525-575a-4204-912d-4462530f0e39 0143-9713 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130213 ANDA ANDA076063 West-Ward Pharmaceutical Corp LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-9714_ca560525-575a-4204-912d-4462530f0e39 0143-9714 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130213 ANDA ANDA076063 West-Ward Pharmaceutical Corp LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-9715_ca560525-575a-4204-912d-4462530f0e39 0143-9715 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130213 ANDA ANDA076063 West-Ward Pharmaceutical Corp LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-9716_ca560525-575a-4204-912d-4462530f0e39 0143-9716 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130213 ANDA ANDA076063 West-Ward Pharmaceutical Corp LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0143-9717_ed44dc8e-76f2-435e-b6c1-1c57c36babf6 0143-9717 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20090609 ANDA ANDA090035 West-ward Pharmaceutical Corp FOLIC ACID 1 mg/1 0143-9718_a498acd3-26af-4e3e-a0d9-cb9b8a6e1766 0143-9718 HUMAN PRESCRIPTION DRUG Milrinone Lactate Milrinone Lactate INJECTION, SOLUTION INTRAVENOUS 20100121 ANDA ANDA090038 West-ward Pharmaceutical Corp MILRINONE LACTATE 200 ug/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0143-9719_a498acd3-26af-4e3e-a0d9-cb9b8a6e1766 0143-9719 HUMAN PRESCRIPTION DRUG Milrinone Lactate Milrinone Lactate INJECTION, SOLUTION INTRAVENOUS 20100121 ANDA ANDA090038 West-ward Pharmaceutical Corp MILRINONE LACTATE 200 ug/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0143-9720_3f756952-2623-4020-96b6-bbd8f85d9213 0143-9720 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20110916 ANDA ANDA091375 West-Ward Pharmaceutical Corp LEVOFLOXACIN 750 mg/150mL 0143-9721_3f756952-2623-4020-96b6-bbd8f85d9213 0143-9721 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20110916 ANDA ANDA091375 West-Ward Pharmaceutical Corp LEVOFLOXACIN 500 mg/100mL 0143-9722_3f756952-2623-4020-96b6-bbd8f85d9213 0143-9722 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20110916 ANDA ANDA091375 West-Ward Pharmaceutical Corp LEVOFLOXACIN 250 mg/50mL 0143-9723_00d89444-a57a-42f0-b392-f44701802be1 0143-9723 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20110101 ANDA ANDA200300 West-ward Pharmaceutical Corp CLONIDINE HYDROCHLORIDE 500 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0143-9724_00d89444-a57a-42f0-b392-f44701802be1 0143-9724 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20110101 ANDA ANDA200300 West-ward Pharmaceutical Corp CLONIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0143-9725_5e444913-7afc-42d3-abf2-6c5dd2d51d7d 0143-9725 HUMAN PRESCRIPTION DRUG Progesterone Progesterone INJECTION INTRAMUSCULAR 20101028 ANDA ANDA091033 West-ward Pharmaceutical Corp PROGESTERONE 50 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 0143-9726_ec94114e-9925-427a-a5a2-f8214a350733 0143-9726 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION INTRAMUSCULAR 20120501 ANDA ANDA091244 West-Ward Pharmaceutical Corp TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0143-9728_e3d84b78-e69d-4898-811c-c00ad67ea830 0143-9728 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol INJECTION INTRAVENOUS 20060208 ANDA ANDA077102 West-ward Pharmaceutical Corp CALCITRIOL 1 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0143-9729_b2f18b99-f374-4d49-a556-babb60918a4f 0143-9729 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20090901 ANDA ANDA090287 West-Ward Pharmaceutical Corp BENZTROPINE MESYLATE 1 mg/mL Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0143-9738_ce1db3f8-396b-4539-89ef-44c709876400 0143-9738 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 West-Ward Pharmaceutical Corp PREDNISONE 20 mg/1 0143-9739_ce1db3f8-396b-4539-89ef-44c709876400 0143-9739 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA088832 West-Ward Pharmaceutical Corp PREDNISONE 10 mg/1 0143-9740_ce1db3f8-396b-4539-89ef-44c709876400 0143-9740 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA080292 West-Ward Pharmaceutical Corp PREDNISONE 5 mg/1 0143-9742_7d661c28-a16f-4ff0-8447-8f8d60208d49 0143-9742 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION INTRAMUSCULAR; INTRAVENOUS 20130213 ANDA ANDA200219 West-Ward Pharmaceutical Corp OXYTOCIN 10 [USP'U]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 0143-9743_7d661c28-a16f-4ff0-8447-8f8d60208d49 0143-9743 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION INTRAMUSCULAR; INTRAVENOUS 20130213 ANDA ANDA200219 West-Ward Pharmaceutical Corp OXYTOCIN 10 [USP'U]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 0143-9744_11245032-719a-471f-9687-28946623205d 0143-9744 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride INJECTION INTRAVENOUS 20091223 ANDA ANDA078629 West-Ward Pharmaceutical Corp GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0143-9745_11245032-719a-471f-9687-28946623205d 0143-9745 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride INJECTION INTRAVENOUS 20091223 ANDA ANDA078629 West-Ward Pharmaceutical Corp GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0143-9746_bbabb8e2-a9e3-4615-8504-48801c87605f 0143-9746 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate INJECTION SUBCUTANEOUS 20090520 ANDA ANDA078630 West-ward Pharmaceutical Corp TERBUTALINE SULFATE 1 mg/mL 0143-9747_3999cda9-e27c-46e9-9cf3-f9d00b62b296 0143-9747 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090247 West-ward Pharmaceutical Corp DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0143-9748_3999cda9-e27c-46e9-9cf3-f9d00b62b296 0143-9748 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090247 West-ward Pharmaceutical Corp DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0143-9749_91bd329a-9bbd-487a-a9c2-ec0a27d3d78c 0143-9749 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19960124 ANDA ANDA040124 West-ward Pharmaceutical Corp CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0143-9750_75b260dd-1430-48d0-9a41-6138f1b9c0fb 0143-9750 HUMAN PRESCRIPTION DRUG TESTOSTERONE ENANTHATE TESTOSTERONE ENANTHATE INJECTION, SOLUTION INTRAMUSCULAR 20120918 ANDA ANDA091120 West-Ward Pharmaceutical Corp TESTOSTERONE ENANTHATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0143-9755_624e570a-6d98-4eb0-8a23-e708ab8df0d1 0143-9755 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20131202 ANDA ANDA091185 West-Ward Pharmaceutical Corp TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0143-9756_624e570a-6d98-4eb0-8a23-e708ab8df0d1 0143-9756 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20131202 ANDA ANDA091185 West-Ward Pharmaceutical Corp TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0143-9757_624e570a-6d98-4eb0-8a23-e708ab8df0d1 0143-9757 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20131202 ANDA ANDA091185 West-Ward Pharmaceutical Corp TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0143-9758_624e570a-6d98-4eb0-8a23-e708ab8df0d1 0143-9758 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20131202 ANDA ANDA091185 West-Ward Pharmaceutical Corp TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0143-9768_8c1c49da-f141-4040-8119-77980f1d10cd 0143-9768 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20090806 ANDA ANDA065328 West-Ward Pharmaceutical Corp CEFTRIAXONE SODIUM 10 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9769_bf7ebcb2-b720-4c58-8dde-a7f5e7eb2374 0143-9769 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin SUSPENSION ORAL 20090901 ANDA ANDA065444 West-ward Pharmaceutical Corp CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9770_bf7ebcb2-b720-4c58-8dde-a7f5e7eb2374 0143-9770 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin SUSPENSION ORAL 20090901 ANDA ANDA065444 West-ward Pharmaceutical Corp CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9771_b81ba160-bb0d-4d28-a191-20d2cd646bea 0143-9771 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride and Dextrose Ondansetron Hydrochloride and Dextrose INJECTION, SOLUTION INTRAVENOUS 20090804 ANDA ANDA078308 West-ward Pharmaceutical Corp ONDANSETRON HYDROCHLORIDE 32 mg/50mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0143-9772_3f26593b-687f-47ba-8ad9-621d39c45b6b 0143-9772 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole INJECTION, SOLUTION INTRAVENOUS 20090804 ANDA ANDA078084 West-ward Pharmaceutical Corp METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0143-9775_6ad21a7c-8e5b-4b61-8f11-d3cd921d8c12 0143-9775 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110621 ANDA ANDA078767 West-ward Pharmaceutical Corp LEVOFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0143-9776_6ad21a7c-8e5b-4b61-8f11-d3cd921d8c12 0143-9776 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110621 ANDA ANDA078767 West-ward Pharmaceutical Corp LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0143-9777_6ad21a7c-8e5b-4b61-8f11-d3cd921d8c12 0143-9777 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110621 ANDA ANDA078767 West-ward Pharmaceutical Corp LEVOFLOXACIN 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0143-9782_fce52518-fe86-4789-89a4-0393a0975bcb 0143-9782 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091202 ANDA ANDA078765 West-Ward Pharmaceutical Corp FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0143-9783_821625e9-3c2d-4b12-90c6-ef18daf6179e 0143-9783 HUMAN PRESCRIPTION DRUG Flumazenil flumazenil INJECTION, SOLUTION INTRAVENOUS 20070101 ANDA ANDA078527 West-ward Pharmaceutical Corp FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 0143-9784_821625e9-3c2d-4b12-90c6-ef18daf6179e 0143-9784 HUMAN PRESCRIPTION DRUG Flumazenil flumazenil INJECTION, SOLUTION INTRAVENOUS 20070101 ANDA ANDA078527 West-ward Pharmaceutical Corp FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 0143-9785_a039252c-3d4e-4d64-94ce-aae9b97b9d16 0143-9785 HUMAN PRESCRIPTION DRUG Valproate Sodium Valproate Sodium INJECTION INTRAVENOUS 20100217 ANDA ANDA078523 West-Ward Pharmaceutical Corp VALPROATE SODIUM 500 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0143-9786_81ce7020-cda4-43fa-bfa3-d642918c5aeb 0143-9786 HUMAN PRESCRIPTION DRUG Enalaprilat enalaprilat INJECTION INTRAVENOUS 20081223 ANDA ANDA078687 West-ward Pharmaceutical Corp ENALAPRILAT 2.5 mg/2mL 0143-9787_81ce7020-cda4-43fa-bfa3-d642918c5aeb 0143-9787 HUMAN PRESCRIPTION DRUG Enalaprilat enalaprilat INJECTION INTRAVENOUS 20081223 ANDA ANDA078687 West-ward Pharmaceutical Corp ENALAPRILAT 1.25 mg/mL 0143-9788_fce52518-fe86-4789-89a4-0393a0975bcb 0143-9788 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVASCULAR 20091202 ANDA ANDA078765 West-Ward Pharmaceutical Corp FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0143-9803_1aa2d989-1240-411e-a8c6-720d9f214063 0143-9803 HUMAN PRESCRIPTION DRUG Doxycyclate Hyclate Doxycycline Hyclate CAPSULE ORAL 19900901 ANDA ANDA062396 West-Ward Pharmaceutical Corp DOXYCYCLINE HYCLATE 100 mg/1 0143-9807_7b46322f-bb56-4669-8215-2ff7862e208d 0143-9807 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 West-ward Pharmaceutical Corp ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0143-9808_7b46322f-bb56-4669-8215-2ff7862e208d 0143-9808 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 West-ward Pharmaceutical Corp ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0143-9809_7b46322f-bb56-4669-8215-2ff7862e208d 0143-9809 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 West-ward Pharmaceutical Corp ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0143-9836_405867ec-0e26-4f0e-96ed-c82296173a4a 0143-9836 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20131011 ANDA ANDA090549 West-Ward Pharmaceutical Corp PENICILLIN V POTASSIUM 500 mg/1 0143-9837_405867ec-0e26-4f0e-96ed-c82296173a4a 0143-9837 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20131011 ANDA ANDA090549 West-Ward Pharmaceutical Corp PENICILLIN V POTASSIUM 250 mg/1 0143-9853_f069c3c1-ff3b-4cc6-9d2c-9e75d208c91e 0143-9853 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium SUSPENSION ORAL 20090803 ANDA ANDA065373 West-ward Pharmaceutical Corp AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0143-9856_a5ec59cb-6c72-4776-af48-da1c0cdef22e 0143-9856 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080110 ANDA ANDA065342 West-Ward Pharmaceutical Corp CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9857_a5ec59cb-6c72-4776-af48-da1c0cdef22e 0143-9857 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080110 ANDA ANDA065342 West-Ward Pharmaceutical Corp CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9858_a5ec59cb-6c72-4776-af48-da1c0cdef22e 0143-9858 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080110 ANDA ANDA065342 West-Ward Pharmaceutical Corp CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9859_a5ec59cb-6c72-4776-af48-da1c0cdef22e 0143-9859 HUMAN PRESCRIPTION DRUG Ceftriaxone ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080110 ANDA ANDA065342 West-Ward Pharmaceutical Corp CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9864_c3796717-85dc-44f9-ac02-52e49830772a 0143-9864 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate Butorphanol Tartrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090501 ANDA ANDA078400 West-ward Pharmaceutical Corp BUTORPHANOL TARTRATE 1 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] 0143-9867_c3796717-85dc-44f9-ac02-52e49830772a 0143-9867 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate Butorphanol Tartrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090501 ANDA ANDA078400 West-ward Pharmaceutical Corp BUTORPHANOL TARTRATE 2 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] 0143-9868_660fbfeb-88d5-43a8-a841-ba51691d99c6 0143-9868 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20080424 ANDA ANDA040737 West-ward Pharmaceutical Corp PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0143-9869_660fbfeb-88d5-43a8-a841-ba51691d99c6 0143-9869 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20080424 ANDA ANDA040737 West-ward Pharmaceutical Corp PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0143-9872_d7703839-d813-46be-9e3b-28e3f5e97043 0143-9872 HUMAN PRESCRIPTION DRUG Propranolol Propranolol INJECTION INTRAVENOUS 20080131 ANDA ANDA077760 West-ward Pharmaceutical Corp PROPRANOLOL HYDROCHLORIDE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0143-9873_f0108f75-7b4e-4669-9b81-bee279fcb430 0143-9873 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 20070530 ANDA ANDA077761 West-Ward Pharmaceutical Corp METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0143-9875_54baacc1-856d-4516-b554-f317643902cc 0143-9875 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20080225 ANDA ANDA077234 West-ward Pharmaceutical Corp AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0143-9876_b432696a-f12e-4fd8-8385-d77613bb8c72 0143-9876 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100226 ANDA ANDA065239 West-ward Pharmaceutical Corp CEFOXITIN SODIUM 1 g/10mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9877_95136ac5-31f8-40bc-b994-6a474806fd0a 0143-9877 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100312 ANDA ANDA065238 West-ward Pharmaceutical Corp CEFOXITIN SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9878_95136ac5-31f8-40bc-b994-6a474806fd0a 0143-9878 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100312 ANDA ANDA065238 West-ward Pharmaceutical Corp CEFOXITIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9886_130649aa-1599-4ab3-a71e-fc3e015fae64 0143-9886 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 West-Ward Pharmaceutical Corp AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0143-9887_130649aa-1599-4ab3-a71e-fc3e015fae64 0143-9887 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 West-Ward Pharmaceutical Corp AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0143-9888_130649aa-1599-4ab3-a71e-fc3e015fae64 0143-9888 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 West-Ward Pharmaceutical Corp AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0143-9889_130649aa-1599-4ab3-a71e-fc3e015fae64 0143-9889 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 West-Ward Pharmaceutical Corp AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0143-9890_612f6c07-309c-45d4-985d-ff9cc8a5fcc5 0143-9890 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA076781 West-Ward Pharmaceutical Corp ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0143-9891_612f6c07-309c-45d4-985d-ff9cc8a5fcc5 0143-9891 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA076780 West-Ward Pharmaceutical Corp ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0143-9897_b0eabaad-ce4d-45db-8c84-95191f9df009 0143-9897 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060201 ANDA ANDA065215 West-ward Pharmaceutical Corp CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9898_b0eabaad-ce4d-45db-8c84-95191f9df009 0143-9898 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060201 ANDA ANDA065215 West-ward Pharmaceutical Corp CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9899_332a2f81-4e4a-4202-beec-64e2d13d794c 0143-9899 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20050823 ANDA ANDA076736 West-Ward Pharmaceutical Corp FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0143-9908_23f89437-006e-4487-b224-f48045dab0b5 0143-9908 HUMAN PRESCRIPTION DRUG NAPROXEN naproxen sodium TABLET, FILM COATED ORAL 19960514 ANDA ANDA074480 West-Ward Pharmaceutical Corp NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0143-9916_23f89437-006e-4487-b224-f48045dab0b5 0143-9916 HUMAN PRESCRIPTION DRUG NAPROXEN naproxen sodium TABLET, FILM COATED ORAL 19980218 ANDA ANDA074480 West-Ward Pharmaceutical Corp NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0143-9918_e4f7414f-bcd6-4440-a4ea-96afb9844838 0143-9918 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20030801 ANDA ANDA075890 West-Ward Pharmaceutical Corp GLYBURIDE 1.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0143-9919_e4f7414f-bcd6-4440-a4ea-96afb9844838 0143-9919 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20030801 ANDA ANDA075890 West-Ward Pharmaceutical Corp GLYBURIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0143-9920_e4f7414f-bcd6-4440-a4ea-96afb9844838 0143-9920 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20030801 ANDA ANDA075890 West-Ward Pharmaceutical Corp GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0143-9923_8c30b3aa-8388-4ad9-bdad-bce3f260021e 0143-9923 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010918 ANDA ANDA065047 West-Ward Pharmaceutical Corp CEFAZOLIN SODIUM 225 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9924_8c30b3aa-8388-4ad9-bdad-bce3f260021e 0143-9924 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010918 ANDA ANDA065047 West-Ward Pharmaceutical Corp CEFAZOLIN SODIUM 330 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9927_06c9c9d0-cbab-4686-9a2c-56abd2a4d8a0 0143-9927 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 West-Ward Pharmaceutical Corp CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0143-9928_06c9c9d0-cbab-4686-9a2c-56abd2a4d8a0 0143-9928 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 West-Ward Pharmaceutical Corp CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0143-9929_06c9c9d0-cbab-4686-9a2c-56abd2a4d8a0 0143-9929 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 West-Ward Pharmaceutical Corp CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0143-9930_3d7a0ba8-fd98-4cd5-9ca3-053c3cdf8df2 0143-9930 HUMAN PRESCRIPTION DRUG Cefotaxime Cefotaxime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20021120 ANDA ANDA065072 West-Ward Pharmaceutical Corp CEFOTAXIME SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9931_3d7a0ba8-fd98-4cd5-9ca3-053c3cdf8df2 0143-9931 HUMAN PRESCRIPTION DRUG Cefotaxime Cefotaxime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20021120 ANDA ANDA065072 West-Ward Pharmaceutical Corp CEFOTAXIME SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9933_3d7a0ba8-fd98-4cd5-9ca3-053c3cdf8df2 0143-9933 HUMAN PRESCRIPTION DRUG Cefotaxime Cefotaxime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20021120 ANDA ANDA065072 West-Ward Pharmaceutical Corp CEFOTAXIME SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9935_6ce0c3b7-f66f-4615-885b-781776832394 0143-9935 HUMAN PRESCRIPTION DRUG Cefotaxime Cefotaxime INJECTION INTRAVENOUS 20021120 ANDA ANDA065071 West-Ward Pharmaceutical Corp CEFOTAXIME SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9938_e90707f9-ab2d-4154-854a-187eb7e12d47 0143-9938 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20070301 ANDA ANDA065291 West-ward Pharmaceutical Corp AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0143-9939_e90707f9-ab2d-4154-854a-187eb7e12d47 0143-9939 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20070301 ANDA ANDA065291 West-ward Pharmaceutical Corp AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0143-9947_30ceca75-1b89-49ef-b18b-9a690f8b068f 0143-9947 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20060207 ANDA ANDA065311 West-Ward Pharmaceutical Corp CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9948_df80802f-b661-445f-ab63-bcbd61a795b1 0143-9948 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil TABLET, FILM COATED ORAL 20060330 ANDA ANDA065260 West-Ward Pharmaceutical Corp CEFADROXIL 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9951_466bcf1d-a4f2-4cd0-bc27-5b9b84e263b2 0143-9951 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20060329 ANDA ANDA065255 West-ward Pharmaceutical Corp AMOXICILLIN 875 mg/1 0143-9959_262ddd0d-1312-4fa6-b479-55ae84214b97 0143-9959 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20110412 ANDA ANDA077771 West-ward Pharmaceutical Corp AMLODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0143-9960_262ddd0d-1312-4fa6-b479-55ae84214b97 0143-9960 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20110412 ANDA ANDA077771 West-ward Pharmaceutical Corp AMLODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0143-9961_262ddd0d-1312-4fa6-b479-55ae84214b97 0143-9961 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20110412 ANDA ANDA077771 West-ward Pharmaceutical Corp AMLODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0143-9962_44d3d32b-6e68-4915-920e-ede52ed92f26 0143-9962 HUMAN PRESCRIPTION DRUG Zolpidem Zolpidem Tartrate TABLET ORAL 20080430 ANDA ANDA078129 West-ward Pharmaceutical Corp ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0143-9963_44d3d32b-6e68-4915-920e-ede52ed92f26 0143-9963 HUMAN PRESCRIPTION DRUG Zolpidem Zolpidem Tartrate TABLET ORAL 20080430 ANDA ANDA078129 West-ward Pharmaceutical Corp ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0143-9964_f3575e3b-3675-4c55-a717-f78cfdc07005 0143-9964 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110419 ANDA ANDA078134 West-ward Pharmaceutical Corp LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0143-9965_f3575e3b-3675-4c55-a717-f78cfdc07005 0143-9965 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110419 ANDA ANDA078134 West-ward Pharmaceutical Corp LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0143-9966_f3575e3b-3675-4c55-a717-f78cfdc07005 0143-9966 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110419 ANDA ANDA078134 West-ward Pharmaceutical Corp LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0143-9967_f3575e3b-3675-4c55-a717-f78cfdc07005 0143-9967 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110419 ANDA ANDA078134 West-ward Pharmaceutical Corp LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0143-9976_a7e702f9-9c04-4d75-8360-5871ca0a2fe5 0143-9976 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION INTRAVENOUS 20040109 ANDA ANDA065046 West-ward Pharmaceutical Corp CEFUROXIME SODIUM 7.5 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9977_c864cc8d-90d5-45b6-b068-e5c720f5d555 0143-9977 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION INTRAMUSCULAR; INTRAVENOUS 20040109 ANDA ANDA065048 West-ward Pharmaceutical Corp CEFUROXIME SODIUM 1.5 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9979_c864cc8d-90d5-45b6-b068-e5c720f5d555 0143-9979 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION INTRAMUSCULAR; INTRAVENOUS 20040109 ANDA ANDA065048 West-ward Pharmaceutical Corp CEFUROXIME SODIUM 750 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9981_910853ad-d8cf-4b3c-8440-17ce438a799b 0143-9981 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20071201 ANDA ANDA065191 West-Ward Pharmaceutical Corp AMOXICILLIN; CLAVULANIC ACID 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0143-9982_910853ad-d8cf-4b3c-8440-17ce438a799b 0143-9982 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20071201 ANDA ANDA065191 West-Ward Pharmaceutical Corp AMOXICILLIN; CLAVULANIC ACID 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0143-9983_bf84ea27-1c71-4bae-bf7a-b96b2d8734c5 0143-9983 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20041018 ANDA ANDA065143 West-Ward Pharmaceutical Corp CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0143-9985_3d7c2e17-44f4-404a-b4ef-e54c41c008f2 0143-9985 HUMAN PRESCRIPTION DRUG CEFACLOR CEFACLOR CAPSULE ORAL 20070501 ANDA ANDA065350 West-ward Pharmaceutical Corp CEFACLOR 250 mg/1 0143-9986_3d7c2e17-44f4-404a-b4ef-e54c41c008f2 0143-9986 HUMAN PRESCRIPTION DRUG CEFACLOR CEFACLOR CAPSULE ORAL 20070501 ANDA ANDA065350 West-ward Pharmaceutical Corp CEFACLOR 500 mg/1 0143-9992_02f23e78-3140-458b-9955-021229fb1d67 0143-9992 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 West-ward Pharmaceutical Corp GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0143-9993_02f23e78-3140-458b-9955-021229fb1d67 0143-9993 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 West-ward Pharmaceutical Corp GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0143-9994_02f23e78-3140-458b-9955-021229fb1d67 0143-9994 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 West-ward Pharmaceutical Corp GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0145-0020_cf4ed061-b795-4aa2-b9e2-7731e884ae02 0145-0020 HUMAN PRESCRIPTION DRUG Fabior tazarotene AEROSOL, FOAM TOPICAL 20130904 NDA NDA202428 Stiefel Laboratories, Inc. TAZAROTENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0145-0021_6094e3c6-ba85-4774-a61d-233f92b92c6c 0145-0021 HUMAN PRESCRIPTION DRUG LUXIQ betamethasone valerate AEROSOL, FOAM TOPICAL 20091016 20150228 NDA NDA020934 Stiefel Laboratories Inc BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0145-0061_d30cbe65-e56a-4e05-998e-c7ecccf253d1 0145-0061 HUMAN PRESCRIPTION DRUG EVOCLIN clindamycin phosphate AEROSOL, FOAM TOPICAL 20091005 20150630 NDA NDA050801 Stiefel Laboratories Inc CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0145-0071_12739e0e-c2c5-4642-8d55-c13eff5cef96 0145-0071 HUMAN PRESCRIPTION DRUG VELTIN clindamycin phosphate and tretinoin GEL TOPICAL 20100729 NDA NDA050803 Stiefel Laboratories Inc CLINDAMYCIN PHOSPHATE; TRETINOIN 10; .25 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient],Retinoid [EPC],Retinoids [Chemical/Ingredient] 0145-0090_e9c803fe-0e27-492a-9ab9-3f7998e14e5d 0145-0090 HUMAN PRESCRIPTION DRUG SORIATANE acitretin CAPSULE ORAL 19961101 NDA NDA019821 Stiefel Laboratories Inc ACITRETIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 0145-0091_e9c803fe-0e27-492a-9ab9-3f7998e14e5d 0145-0091 HUMAN PRESCRIPTION DRUG SORIATANE acitretin CAPSULE ORAL 19961101 NDA NDA019821 Stiefel Laboratories Inc ACITRETIN 25 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 0145-0628_d636434e-d092-49bc-8e6b-2b6c9d8a1f34 0145-0628 HUMAN OTC DRUG Sarna camphor and menthol LOTION TOPICAL 20110222 OTC MONOGRAPH NOT FINAL part348 Stiefel Laboratories, Inc CAMPHOR (NATURAL); MENTHOL .6; .6 mg/mL; mg/mL 0145-0630_6ddf3088-2c0e-414c-a38c-dd327e0d3abb 0145-0630 HUMAN OTC DRUG Sarna pramoxine hydrochloride LOTION TOPICAL 20110222 OTC MONOGRAPH NOT FINAL part348 Stiefel Laboratories, Inc PRAMOXINE HYDROCHLORIDE 1 mg/mL 0145-0982_f6a46e4d-916a-4cb4-89b0-45141f62fd06 0145-0982 HUMAN OTC DRUG PanOxyl benzoyl peroxide SOAP TOPICAL 20101110 OTC MONOGRAPH FINAL part333D Stiefel Laboratories Inc BENZOYL PEROXIDE .5 g/10g 0145-0983_f6a46e4d-916a-4cb4-89b0-45141f62fd06 0145-0983 HUMAN OTC DRUG PanOxyl benzoyl peroxide SOAP TOPICAL 20101110 OTC MONOGRAPH FINAL part333D Stiefel Laboratories Inc BENZOYL PEROXIDE 1 g/10g 0145-0985_4239f211-432b-4ebe-bb17-d538ebcf09fe 0145-0985 HUMAN OTC DRUG PanOxyl benzoyl peroxide CREAM TOPICAL 20110325 OTC MONOGRAPH FINAL part333D Stiefel Laboratories Inc BENZOYL PEROXIDE 146.7 mg/g 0145-1501_22a6b41f-e3c1-445f-a01f-5c5661688d0e 0145-1501 HUMAN OTC DRUG Zeasorb miconazole nitrate POWDER TOPICAL 20110314 OTC MONOGRAPH FINAL part333C Stiefel Laboratories Inc MICONAZOLE NITRATE 20.6 mg/g 0145-1506_22a6b41f-e3c1-445f-a01f-5c5661688d0e 0145-1506 HUMAN OTC DRUG Zeasorb miconazole nitrate POWDER TOPICAL 20110314 OTC MONOGRAPH FINAL part333C Stiefel Laboratories Inc MICONAZOLE NITRATE 20.6 mg/g 0145-2130_58ae05f4-d9a1-4b17-ae95-8b0c7b3f49a7 0145-2130 HUMAN PRESCRIPTION DRUG SORILUX calcipotriene AEROSOL, FOAM TOPICAL 20101026 NDA NDA022563 Stiefel Laboratories Inc CALCIPOTRIENE 50 ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 0145-2371_bde06617-46d2-47a8-9f7f-ccd76f9840c9 0145-2371 HUMAN PRESCRIPTION DRUG DUAC clindamycin phosphate and benzoyl peroxide GEL TOPICAL 20071022 NDA NDA050741 Stiefel Laboratories Inc BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 50; 10 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0145-2651_4239f211-432b-4ebe-bb17-d538ebcf09fe 0145-2651 HUMAN OTC DRUG PanOxyl benzoyl peroxide CREAM TOPICAL 20140408 OTC MONOGRAPH FINAL part333D Stiefel Laboratories Inc BENZOYL PEROXIDE 30 mg/g 0145-2660_4239f211-432b-4ebe-bb17-d538ebcf09fe 0145-2660 HUMAN OTC DRUG PanOxyl benzoyl peroxide CREAM TOPICAL 20110325 OTC MONOGRAPH FINAL part333D Stiefel Laboratories Inc BENZOYL PEROXIDE 58.7 mg/g 0145-3817_e9c803fe-0e27-492a-9ab9-3f7998e14e5d 0145-3817 HUMAN PRESCRIPTION DRUG SORIATANE acitretin CAPSULE ORAL 20100104 NDA NDA019821 Stiefel Laboratories Inc ACITRETIN 17.5 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 0149-0470_05985725-417c-44f4-9e38-4fed7cdfdaad 0149-0470 HUMAN PRESCRIPTION DRUG ACTONEL RISEDRONATE SODIUM TABLET, FILM COATED ORAL 19980327 NDA NDA020835 Warner Chilcott Pharmaceuticals Inc. RISEDRONATE SODIUM 30 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0149-0471_05985725-417c-44f4-9e38-4fed7cdfdaad 0149-0471 HUMAN PRESCRIPTION DRUG ACTONEL RISEDRONATE SODIUM TABLET, FILM COATED ORAL 20000414 NDA NDA020835 Warner Chilcott Pharmaceuticals Inc. RISEDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0149-0472_05985725-417c-44f4-9e38-4fed7cdfdaad 0149-0472 HUMAN PRESCRIPTION DRUG ACTONEL RISEDRONATE SODIUM TABLET, FILM COATED ORAL 20020517 NDA NDA020835 Warner Chilcott Pharmaceuticals Inc. RISEDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0149-0478_05985725-417c-44f4-9e38-4fed7cdfdaad 0149-0478 HUMAN PRESCRIPTION DRUG ACTONEL RISEDRONATE SODIUM TABLET, FILM COATED ORAL 20080422 NDA NDA020835 Warner Chilcott Pharmaceuticals Inc. RISEDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0159-2200_c2621ff6-9cc9-41d2-95f6-d3fda4f2d7a6 0159-2200 HUMAN OTC DRUG Selan Plus Zinc Oxide Selan Plus Zinc Oxide CREAM TOPICAL 19970829 OTC MONOGRAPH FINAL part347 PJ Noyes Co. Inc. DIMETHICONE; ZINC OXIDE 2.1; 2 1/100g; g/100g 0159-2400_0b4797d2-7f03-461b-a839-7ff983767423 0159-2400 HUMAN OTC DRUG Selan Plus Zinc Selan Plus Zinc LOTION TOPICAL 19970829 OTC MONOGRAPH FINAL part347 PJ Noyes Co. Inc. DIMETHICONE; ZINC OXIDE 2.3; 2 g/100g; g/100g 0159-2500_1540e0ad-559d-4897-a972-0e7443086246 0159-2500 HUMAN OTC DRUG Selan Antifungal Selan Antifungal CREAM TOPICAL 20031105 OTC MONOGRAPH FINAL part333C PJ Noyes Co. Inc. MICONAZOLE NITRATE 2 g/100g 0164-2189_5f0f7acc-f134-43bb-9797-48e73a35e64f 0164-2189 HUMAN OTC DRUG CALENDULA DIAPER RASH CREAM ZINC OXIDE CREAM TOPICAL 20130627 OTC MONOGRAPH FINAL part347 Weleda A.G. Schwabisch Gmund, Zweigniederlassung der Weled ZINC OXIDE 12 g/100g 0164-2207_436b3d70-1250-4ad2-a8d9-ead21ada6ec2 0164-2207 HUMAN OTC DRUG WHITE MALLOW DIAPER RASH CREAM ZINC OXIDE CREAM TOPICAL 20140822 OTC MONOGRAPH FINAL part347 Weleda A.G. Schwabisch Gmund, Zweigniederlassung der Weled ZINC OXIDE 14 g/100g 0168-0002_ce26442b-18cd-441f-af9a-43f63f250752 0168-0002 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE 5 mg/g 0168-0003_ce26442b-18cd-441f-af9a-43f63f250752 0168-0003 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE .25 mg/g 0168-0004_ce26442b-18cd-441f-af9a-43f63f250752 0168-0004 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE 1 mg/g 0168-0005_a5f3e9c1-ef55-4362-8298-5e683a8296f8 0168-0005 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide OINTMENT TOPICAL 19780214 ANDA ANDA085691 E. Fougera & CO., A division of Fougera Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE .25 mg/g 0168-0006_a5f3e9c1-ef55-4362-8298-5e683a8296f8 0168-0006 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide OINTMENT TOPICAL 19780214 ANDA ANDA085691 E. Fougera & CO., A division of Fougera Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE 1 mg/g 0168-0007_22c7e939-c21c-44ea-a25a-21799f910b6a 0168-0007 HUMAN PRESCRIPTION DRUG Nystatin nystatin OINTMENT TOPICAL 19820923 ANDA ANDA062124 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 0168-0011_b0d23ca9-a19e-4105-8a2c-14b9065a4cf3 0168-0011 HUMAN OTC DRUG Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 20100108 OTC MONOGRAPH FINAL part333B E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. BACITRACIN ZINC 500 [USP'U]/g 0168-0012_17785628-26c0-4498-aba8-c121fafb36d4 0168-0012 HUMAN OTC DRUG Triple Antibiotic Neomycin and Polymyxin B Sulfates and Bacitracin Zinc OINTMENT TOPICAL 20100106 OTC MONOGRAPH FINAL part333B E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 0168-0014_c93b88e1-c15b-42ba-a8fb-7bbc37cdc0bb 0168-0014 HUMAN OTC DRUG HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 19680101 OTC MONOGRAPH FINAL part348 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 5 mg/g 0168-0015_1e8a8e3b-e3ed-4985-a7e5-4a6b5c093c8d 0168-0015 HUMAN PRESCRIPTION DRUG hydrocortisone Hydrocortisone CREAM TOPICAL 19760430 ANDA ANDA080693 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0016_293ecf1f-6b74-4484-a61f-57e5421c1729 0168-0016 HUMAN OTC DRUG HYDROCORTISONE HYDROCORTISONE OINTMENT TOPICAL 19810101 OTC MONOGRAPH FINAL part348 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 5 mg/g 0168-0020_113f35a6-8ffd-4595-8d5a-21f244fc3fbf 0168-0020 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19750416 ANDA ANDA080692 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0021_443a7f87-7fdc-4c44-aad9-f7d8441e7f2a 0168-0021 HUMAN OTC DRUG Double Antibiotic Bacitracin Zinc and Polymyxin B Sulfate OINTMENT TOPICAL 20100106 OTC MONOGRAPH FINAL part333B E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g 0168-0033_05bc95af-9436-41e0-90ed-745cee7c03d9 0168-0033 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate OINTMENT TOPICAL 19830831 NDA NDA018865 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE VALERATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0035_3378f795-df7c-4de8-96dd-99afa2f5d4b6 0168-0035 HUMAN OTC DRUG Vitamin A and Vitamin D Vitamin A and Vitamin D OINTMENT TOPICAL 19810101 OTC MONOGRAPH FINAL part347 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. PETROLATUM 929.3 mg/g 0168-0037_cbc1646c-2fe3-4140-a73c-aaee7c9013c6 0168-0037 HUMAN PRESCRIPTION DRUG nystatin nystatin SUSPENSION ORAL 19840607 ANDA ANDA062517 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 0168-0040_05bc95af-9436-41e0-90ed-745cee7c03d9 0168-0040 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate CREAM TOPICAL 19830831 NDA NDA018861 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE VALERATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0041_05bc95af-9436-41e0-90ed-745cee7c03d9 0168-0041 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate LOTION TOPICAL 19830831 NDA NDA018866 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE VALERATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0046_cc66c053-6c73-4d9b-979b-f508f7c0aa5c 0168-0046 HUMAN OTC DRUG DIBUCAINE DIBUCAINE OINTMENT TOPICAL 19680101 OTC MONOGRAPH FINAL part346 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. DIBUCAINE 1 g/100g 0168-0053_02ef00c3-1c1d-43f9-977c-3f36133b8f30 0168-0053 HUMAN OTC DRUG White Petrolatum White Petrolatum OINTMENT TOPICAL 19680101 OTC MONOGRAPH FINAL part347 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. PETROLATUM 1 g/g 0168-0054_3d5e563c-5fb7-451c-ba85-2671f67781fb 0168-0054 HUMAN PRESCRIPTION DRUG nystatin nystatin CREAM TOPICAL 19790201 ANDA ANDA062129 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 0168-0055_5116738f-2294-4703-971c-71b81a5b5157 0168-0055 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 19840626 NDA NDA019137 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0056_5116738f-2294-4703-971c-71b81a5b5157 0168-0056 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate OINTMENT TOPICAL 19840904 NDA NDA019141 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0057_5116738f-2294-4703-971c-71b81a5b5157 0168-0057 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate LOTION TOPICAL 19850812 ANDA ANDA070275 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0058_155235f2-b842-4f8e-a204-7b97c7686ae9 0168-0058 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide CREAM TOPICAL 19821216 ANDA ANDA088170 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUOCINOLONE ACETONIDE .1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0059_fba53f3a-9445-4426-83fe-7d37d2643a73 0168-0059 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide SOLUTION TOPICAL 19821216 ANDA ANDA088167 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. FLUOCINOLONE ACETONIDE .1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0060_155235f2-b842-4f8e-a204-7b97c7686ae9 0168-0060 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide CREAM TOPICAL 19821216 ANDA ANDA088169 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0062_9b514216-a692-4785-ae86-1b8f92e67e07 0168-0062 HUMAN OTC DRUG ZINC OXIDE ZINC OXIDE OINTMENT TOPICAL 19680101 OTC MONOGRAPH FINAL part347 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ZINC OXIDE 200 mg/g 0168-0064_9e6ded3b-f4d1-48dd-9cec-939ed9704aa9 0168-0064 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide OINTMENT TOPICAL 19821216 ANDA ANDA088168 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0071_d9702c76-5f4e-4a76-b3a4-e7635f39d504 0168-0071 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate gentamicin sulfate CREAM TOPICAL 19840705 ANDA ANDA062531 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. GENTAMICIN SULFATE 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0168-0078_c6dd33a2-904b-4015-8477-5018db198fdc 0168-0078 HUMAN PRESCRIPTION DRUG Gentamicin sulfate Gentamicin Sulfate OINTMENT TOPICAL 20100317 ANDA ANDA062533 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. GENTAMICIN 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0168-0080_482a2ae5-038d-4002-bd07-aa3fa817b5d1 0168-0080 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 19861216 ANDA ANDA089414 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0081_615fe7b2-2f00-4757-a86a-886d7f19f099 0168-0081 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide nystatin and triamcinolone acetonide CREAM TOPICAL 19851008 ANDA ANDA062599 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP&apos'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 0168-0089_4b0b2154-1180-41e9-a8da-5f112e38be72 0168-0089 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide nystatin and triamcinolone acetonide OINTMENT TOPICAL 19851009 ANDA ANDA062602 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 0168-0099_7441c338-96e3-4515-a079-207e9215c7fe 0168-0099 HUMAN PRESCRIPTION DRUG ketoconazole ketoconazole CREAM TOPICAL 20040428 ANDA ANDA076294 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0168-0111_b0d23ca9-a19e-4105-8a2c-14b9065a4cf3 0168-0111 HUMAN OTC DRUG Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 20100108 OTC MONOGRAPH FINAL part333B E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. BACITRACIN ZINC 500 [USP'U]/g 0168-0126_62aa773d-b562-488f-a5a3-bc42c64ecf6f 0168-0126 HUMAN OTC DRUG Swim-EAR Swim-EAR SOLUTION AURICULAR (OTIC) 19700403 OTC MONOGRAPH FINAL part344 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ISOPROPYL ALCOHOL 950 mg/mL 0168-0133_fbd28591-a9e7-417e-803a-5639b477c542 0168-0133 HUMAN PRESCRIPTION DRUG Clotrimazole clotrimazole CREAM TOPICAL 20080902 ANDA ANDA078338 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. CLOTRIMAZOLE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0168-0134_20f87485-96db-40c5-bd94-79bb8f978bed 0168-0134 HUMAN PRESCRIPTION DRUG fluocinonide fluocinonide SOLUTION TOPICAL 19950227 ANDA ANDA072934 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0135_42bab792-cea3-4562-8b4a-026a7a8774c6 0168-0135 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide GEL TOPICAL 19941230 ANDA ANDA072933 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0139_b90b1619-194a-412b-a1f2-eff73ed26f22 0168-0139 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide CREAM TOPICAL 19941017 ANDA ANDA073030 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0140_535364f5-60b2-4afb-a8dd-c98f4d5a1dbf 0168-0140 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide OINTMENT TOPICAL 19970826 ANDA ANDA074905 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0146_482a2ae5-038d-4002-bd07-aa3fa817b5d1 0168-0146 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19930528 ANDA ANDA081203 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0151_88597cd8-9757-4785-9401-5cf87468e411 0168-0151 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 20120928 ANDA ANDA078657 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0154_c2104699-2e63-42f9-a39a-b9de1b6c7579 0168-0154 HUMAN OTC DRUG HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 19760430 OTC MONOGRAPH NOT FINAL part348 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 10 mg/g 0168-0162_4d279079-4a02-47e3-a641-ac9fe5e26ce0 0168-0162 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate OINTMENT TOPICAL 19960223 ANDA ANDA074407 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0163_4d279079-4a02-47e3-a641-ac9fe5e26ce0 0168-0163 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate CREAM TOPICAL 19960930 ANDA ANDA074392 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0180_d09d230b-d6f3-4576-8d08-36da381e06cf 0168-0180 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 20100629 ANDA ANDA078369 E. Fougera & Co., a division of Fougera Pharmaceuticals Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0181_f565cca1-8ab2-4a59-b137-41388b9d7627 0168-0181 HUMAN OTC DRUG HYDROCORTISONE HYDROCORTISONE OINTMENT TOPICAL 19750406 OTC MONOGRAPH NOT FINAL part348 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 10 mg/g 0168-0201_e0752517-f24c-4706-a832-10cdc9c4fc83 0168-0201 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate SOLUTION TOPICAL 19970605 ANDA ANDA064159 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0168-0202_e0752517-f24c-4706-a832-10cdc9c4fc83 0168-0202 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate GEL TOPICAL 20100128 ANDA ANDA064160 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0168-0203_e0752517-f24c-4706-a832-10cdc9c4fc83 0168-0203 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate LOTION TOPICAL 20020131 ANDA ANDA065067 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0168-0204_3d20b848-227b-468e-9a6a-2c51e06cf681 0168-0204 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 19720630 ANDA ANDA080198 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0168-0215_1f7cee4e-f407-4f4d-84ef-12bb2bbe7f4a 0168-0215 HUMAN PRESCRIPTION DRUG Erythromycin erythromycin SOLUTION TOPICAL 19970930 ANDA ANDA064187 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ERYTHROMYCIN 20 mg/mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0168-0216_2a20dc13-a010-4cc8-a08a-7215c6cc58f7 0168-0216 HUMAN PRESCRIPTION DRUG Erythromycin erythromycin GEL TOPICAL 19970930 ANDA ANDA064184 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. ERYTHROMYCIN 20 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0168-0242_619c5e2e-9e32-4a4d-b36b-31e480a5be3d 0168-0242 HUMAN PRESCRIPTION DRUG Diflorasone Diacetate diflorasone diacetate CREAM TOPICAL 19980330 ANDA ANDA075187 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. DIFLORASONE DIACETATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0243_961ec6d3-69a9-42c8-b0bf-62be0fd55a18 0168-0243 HUMAN PRESCRIPTION DRUG Diflorasone Diacetate Diflorasone Diacetate OINTMENT TOPICAL 19990427 ANDA ANDA075374 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. DIFLORASONE DIACETATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0246_6f553d79-de8b-4624-b271-d508bff0abf1 0168-0246 HUMAN PRESCRIPTION DRUG fluocinonide fluocinonide CREAM TOPICAL 20040623 ANDA ANDA076586 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0258_d8bc6907-3ed0-4b09-a038-e92ae8a480dd 0168-0258 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20010605 ANDA ANDA075502 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE .5; 10 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0263_69a6ebd4-3ce4-4195-8564-0f1835270bf7 0168-0263 HUMAN PRESCRIPTION DRUG Alclometasone Dipropionate alclometasone dipropionate CREAM TOPICAL 20050712 ANDA ANDA076973 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. ALCLOMETASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0264_729b0089-46e0-44e0-bf30-f0fcbd3b3af0 0168-0264 HUMAN PRESCRIPTION DRUG Alclometasone Dipropionate alclometasone dipropionate OINTMENT TOPICAL 20050718 ANDA ANDA076884 E. Fougera & Co., a division of Fougera Pharmaceuticals Inc. ALCLOMETASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0265_e9a87e1b-2b1f-4b79-8866-0445f1f04bc1 0168-0265 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone dipropionate CREAM, AUGMENTED TOPICAL 20031209 ANDA ANDA076215 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0266_70a6cd27-7b38-4928-8a8b-eb334960ef5e 0168-0266 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate GEL TOPICAL 20030513 ANDA ANDA075276 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0267_564acb86-c5bf-49f6-b66b-c55404b998db 0168-0267 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate LOTION, AUGMENTED TOPICAL 20070521 ANDA ANDA077111 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0268_a45847f8-0273-4d42-afa8-57d49ec8a547 0168-0268 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate betamethasone dipropionate OINTMENT, AUGMENTED TOPICAL 19990622 ANDA ANDA075373 E. Fougera & Co., a division of Fougera Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0269_e5627a55-6bec-41da-983c-e1985a6b76f9 0168-0269 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate SOLUTION TOPICAL 19990208 ANDA ANDA075391 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0270_b3cfb8df-de41-468b-a16e-75dd33d6001d 0168-0270 HUMAN PRESCRIPTION DRUG Mometasone Furoate mometasone furoate CREAM TOPICAL 20050408 ANDA ANDA076171 E. Fougera & CO., A division of Fougera Pharmaceuticals Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0271_780b8c67-3d6c-42ea-b30c-0d27c4952e51 0168-0271 HUMAN PRESCRIPTION DRUG Mometasone Furoate mometasone furoate OINTMENT TOPICAL 20050328 ANDA ANDA077061 E. FOUGERA & CO. , A division of Fougera Pharmaceuticals Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0272_0c4c1978-0cc1-4b78-902d-18a9cb3bd545 0168-0272 HUMAN PRESCRIPTION DRUG Mometasone Furoate mometasone furoate SOLUTION TOPICAL 20071129 ANDA ANDA075919 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. MOMETASONE FUROATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0273_e16cc886-1989-4220-85ae-6b0cc2e3dee4 0168-0273 HUMAN PRESCRIPTION DRUG Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate OINTMENT OPHTHALMIC 20080828 ANDA ANDA065022 E. FOUGERA & CO., A division of Nycomed US Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 1/g; 1/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 0168-0275_a732ea3e-7ee6-4eca-a8b2-e95ac7134605 0168-0275 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL TOPICAL 20060606 ANDA ANDA077018 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0168-0277_d79b3d96-5de4-4ebe-861d-28985dcd2836 0168-0277 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate clindamycin phosphate CREAM VAGINAL 20041227 ANDA ANDA065139 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. CLINDAMYCIN PHOSPHATE 20 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0168-0278_5eaae9df-92e8-4c26-890d-54dead7e0ccb 0168-0278 HUMAN PRESCRIPTION DRUG Amcinonide Amcinonide CREAM TOPICAL 20030515 ANDA ANDA076065 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. AMCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0279_dda607c9-29ec-40bd-a925-cb74036f4790 0168-0279 HUMAN PRESCRIPTION DRUG Amcinonide amcinonide OINTMENT TOPICAL 20140403 ANDA ANDA076096 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. AMCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0280_7e020def-6509-4e4d-81be-7aae54242d64 0168-0280 HUMAN PRESCRIPTION DRUG amcinonide amcinonide LOTION TOPICAL 20021106 ANDA ANDA076329 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. AMCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0288_08631d09-d424-422a-af85-2298c8ecaa33 0168-0288 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone LOTION TOPICAL 20000725 ANDA ANDA040351 E.FOUGERA & COMPANY A division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0293_4d279079-4a02-47e3-a641-ac9fe5e26ce0 0168-0293 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate GEL TOPICAL 20000215 ANDA ANDA075368 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0301_8c0b73ca-5497-4694-b116-4df8a7ee4452 0168-0301 HUMAN PRESCRIPTION DRUG Clobetasol Propionate (emollient) clobetasol propionate CREAM TOPICAL 19990526 ANDA ANDA075430 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0309_2dd6a1d1-1076-4b94-bf74-5d900a0c6c18 0168-0309 HUMAN PRESCRIPTION DRUG desonide desonide OINTMENT TOPICAL 20101019 ANDA ANDA075751 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0310_d4ebc0e6-d7cf-41b2-a546-e49b7c9848d7 0168-0310 HUMAN PRESCRIPTION DRUG desonide desonide LOTION TOPICAL 20020319 ANDA ANDA075860 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. DESONIDE .5 mg/1000mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0312_ff081c1e-c154-4c1a-b138-e01f21127b44 0168-0312 HUMAN PRESCRIPTION DRUG Econazole Nitrate econazole nitrate CREAM TOPICAL 20021126 ANDA ANDA076075 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0168-0313_2c9efbd4-8a94-4331-b8b3-271d3036e2ff 0168-0313 HUMAN PRESCRIPTION DRUG ciclopirox olamine ciclopirox olamine CREAM TOPICAL 20041229 ANDA ANDA076435 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 0168-0314_e92fdfd3-7e1e-47d2-8a59-4a53b13e8ca9 0168-0314 HUMAN PRESCRIPTION DRUG Ciclopirox ciclopirox LOTION TOPICAL 20040806 ANDA ANDA076422 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. CICLOPIROX OLAMINE 7.7 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 0168-0323_7991e21a-78a9-4853-9b25-70b7f684fe86 0168-0323 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole CREAM TOPICAL 20040528 ANDA ANDA076408 E.FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0168-0326_c0c4328d-68fc-4fea-87aa-93b385f3e7a9 0168-0326 HUMAN PRESCRIPTION DRUG NITRO-BID Nitroglycerin OINTMENT TOPICAL 20090815 ANDA ANDA087355 E. FOUGERA & CO., A division of Nycomed US Inc. NITROGLYCERIN 20 mg/g Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0168-0332_3d6ba8ce-10be-408a-b108-119aec02046f 0168-0332 HUMAN PRESCRIPTION DRUG FLUTICASONE PROPIONATE fluticasone propionate CREAM TOPICAL 20040514 ANDA ANDA076451 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUTICASONE PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0333_981e2c34-853d-43dd-b35e-48e5c20bb871 0168-0333 HUMAN PRESCRIPTION DRUG Fluticasone Propionate fluticasone propionate OINTMENT TOPICAL 20040514 ANDA ANDA076300 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. FLUTICASONE PROPIONATE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0336_44636333-b6b7-41fc-b018-23a7c8ea02a5 0168-0336 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide LOTION TOPICAL 20030421 ANDA ANDA040467 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE .25 mg/mL 0168-0337_44636333-b6b7-41fc-b018-23a7c8ea02a5 0168-0337 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide LOTION TOPICAL 20030421 ANDA ANDA040467 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE 1 mg/mL 0168-0346_65980ec1-f21c-4083-84cc-4b9c2617ed5a 0168-0346 HUMAN PRESCRIPTION DRUG Terconazole terconazole CREAM VAGINAL 20050218 ANDA ANDA076712 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0168-0347_c0111708-86f4-4ba0-bbe3-aad538c9c313 0168-0347 HUMAN PRESCRIPTION DRUG Terconazole Vaginal Cream 0.8% terconazole CREAM VAGINAL 20041001 NDA NDA021735 E. FOUGERA & CO. A division of Nycomed US Inc. TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0168-0352_4d160d97-b381-4761-a40a-238b10af3aec 0168-0352 HUMAN PRESCRIPTION DRUG Mupirocin mupirocin OINTMENT TOPICAL 20051130 ANDA ANDA065192 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 0168-0353_1e38df0b-1c8b-43ce-baa6-5e383f779629 0168-0353 HUMAN PRESCRIPTION DRUG Diflorasone Diacetate diflorasone diacetate CREAM TOPICAL 20021220 ANDA ANDA076263 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. DIFLORASONE DIACETATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0355_e34aaf90-e2e1-4f14-9ca9-7de9cd01ad86 0168-0355 HUMAN PRESCRIPTION DRUG Halobetasol Propionate halobetasol propionate CREAM TOPICAL 20041216 ANDA ANDA077001 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0356_db5eba0e-781c-4383-ab1f-15c025cf4290 0168-0356 HUMAN PRESCRIPTION DRUG Halobetasol Propionate halobetasol propionate OINTMENT TOPICAL 20041216 ANDA ANDA076903 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0357_e8e79604-7b03-4544-b2c9-f370d62cebb6 0168-0357 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine lidocaine and prilocaine CREAM TOPICAL 20030818 ANDA ANDA076453 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0168-0370_695655fe-be0a-4395-a096-71cea10b2574 0168-0370 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate LOTION TOPICAL 20050616 ANDA ANDA076516 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE .5; 10 mg/mL; mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0381_910000b6-6d3f-4512-80d4-b2e3803ad41a 0168-0381 HUMAN PRESCRIPTION DRUG Prednicarbate prednicarbate CREAM TOPICAL 20060919 ANDA ANDA077287 E. Fougera & Co., a division of Fougera Pharmaceuticals Inc. PREDNICARBATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0382_25de4401-a67c-4a55-ae83-68a260a9e722 0168-0382 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SUSPENSION TOPICAL 20061117 ANDA ANDA077015 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0168-0383_ec4afc1a-fc6f-4913-af38-6888f6c0d790 0168-0383 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole LOTION TOPICAL 20060524 ANDA ANDA077197 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. METRONIDAZOLE 7.5 mg/mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0168-0400_63460907-b494-485c-a557-ec3b472e3e68 0168-0400 HUMAN PRESCRIPTION DRUG Calcipotriene Calcipotriene SOLUTION TOPICAL 20080506 ANDA ANDA078305 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CALCIPOTRIENE .05 mg/mL Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 0168-0407_39573f53-6d85-44d3-8a77-c6f02a55fd19 0168-0407 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox GEL TOPICAL 20080610 ANDA ANDA077896 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CICLOPIROX 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 0168-0410_d533c515-45f5-461c-afde-d12f22c47064 0168-0410 HUMAN PRESCRIPTION DRUG Prednicarbate prednicarbate OINTMENT TOPICAL 20070309 ANDA ANDA077236 E. Fougera & Co., a division of Fougera Pharmaceuticals Inc. PREDNICARBATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0416_38ae76eb-6cd6-4673-a4b6-4f9aaa35f1ac 0168-0416 HUMAN PRESCRIPTION DRUG Tacrolimus tacrolimus OINTMENT TOPICAL 20140909 ANDA ANDA200744 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TACROLIMUS 1 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0168-0417_38ae76eb-6cd6-4673-a4b6-4f9aaa35f1ac 0168-0417 HUMAN PRESCRIPTION DRUG Tacrolimus tacrolimus OINTMENT TOPICAL 20140909 ANDA ANDA200744 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TACROLIMUS .3 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0168-0424_f3ae5047-f195-4ad7-81e2-95862b388fa0 0168-0424 HUMAN PRESCRIPTION DRUG Adapalene adapalene CREAM TOPICAL 20100630 ANDA ANDA090824 E. Fougera & Co. A division of Fougera Pharmaceuticals Inc. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0168-0432_67896bb3-f00a-4555-9f58-9c331305f20f 0168-0432 HUMAN PRESCRIPTION DRUG imiquimod imiquimod CREAM TOPICAL 20100225 ANDA ANDA078548 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. IMIQUIMOD 50 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 0168-0434_db95f812-6760-40c0-bf4f-763451a35463 0168-0434 HUMAN PRESCRIPTION DRUG FLUTICASONE PROPIONATE fluticasone propionate LOTION TOPICAL 20091005 NDA AUTHORIZED GENERIC NDA021152 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUTICASONE PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0449_25807bde-73e7-40ba-9c25-496f404e9fb2 0168-0449 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SHAMPOO TOPICAL 20100525 ANDA ANDA090146 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. CICLOPIROX 10 mg/.96mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 0168-0457_12776f58-c571-438a-9fae-9a6e002173c1 0168-0457 HUMAN PRESCRIPTION DRUG fluocinonide fluocinonide CREAM TOPICAL 20140714 ANDA ANDA200735 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0168-0482_2f0c4bdf-185a-4e44-b7ea-ef3e763762b3 0168-0482 HUMAN PRESCRIPTION DRUG Methscopolamine Bromide methscopolamine bromide TABLET ORAL 20110316 NDA AUTHORIZED GENERIC NDA008848 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. METHSCOPOLAMINE BROMIDE 2.5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0168-0483_2f0c4bdf-185a-4e44-b7ea-ef3e763762b3 0168-0483 HUMAN PRESCRIPTION DRUG Methscopolamine Bromide methscopolamine bromide TABLET ORAL 20110727 NDA AUTHORIZED GENERIC NDA008848 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. METHSCOPOLAMINE BROMIDE 5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0168-0484_cc939c60-abf2-40dd-af3c-87281e9fc1ca 0168-0484 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide Sodium Sulfacetamide SOLUTION TOPICAL 20100312 UNAPPROVED DRUG OTHER E. FOUGERA & Co., A division of Nycomed US Inc. SULFACETAMIDE SODIUM 100 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0168-0522_bafc4391-ccba-485a-8362-297d559cb812 0168-0522 HUMAN PRESCRIPTION DRUG Ciclopirox ciclopirox SHAMPOO TOPICAL 20121119 NDA AUTHORIZED GENERIC NDA021159 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CICLOPIROX 10 mg/.96mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 0168-0803_77de238c-7c04-4709-a431-2093e6b8e86e 0168-0803 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM diclofenac sodium GEL TOPICAL 20130506 NDA AUTHORIZED GENERIC NDA021005 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. DICLOFENAC SODIUM 30 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0169-0081_ae6d771d-3937-4e8d-a357-7ea1c4d90b29 0169-0081 HUMAN PRESCRIPTION DRUG Prandin repaglinide TABLET ORAL 20000103 NDA NDA020741 Novo Nordisk REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0169-0082_ae6d771d-3937-4e8d-a357-7ea1c4d90b29 0169-0082 HUMAN PRESCRIPTION DRUG Prandin repaglinide TABLET ORAL 20000103 NDA NDA020741 Novo Nordisk REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0169-0084_ae6d771d-3937-4e8d-a357-7ea1c4d90b29 0169-0084 HUMAN PRESCRIPTION DRUG Prandin repaglinide TABLET ORAL 20000103 NDA NDA020741 Novo Nordisk REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0169-0092_ad18920e-7672-4fba-841a-6607835064d2 0169-0092 HUMAN PRESCRIPTION DRUG PrandiMet repaglinide and metformin hydrochloride TABLET ORAL 20090115 NDA NDA022386 Novo Nordisk METFORMIN HYDROCHLORIDE; REPAGLINIDE 500; 2 mg/1; mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0169-0093_ad18920e-7672-4fba-841a-6607835064d2 0169-0093 HUMAN PRESCRIPTION DRUG PrandiMet repaglinide and metformin hydrochloride TABLET ORAL 20090116 NDA NDA022386 Novo Nordisk METFORMIN HYDROCHLORIDE; REPAGLINIDE 500; 1 mg/1; mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0169-1833_6ede8238-f902-478d-8cee-997855045083 0169-1833 HUMAN OTC DRUG Novolin R Human Insulin INJECTION, SOLUTION SUBCUTANEOUS 19910625 NDA NDA019938 Novo Nordisk INSULIN HUMAN 100 [iU]/mL 0169-1834_6a1423e7-0de8-4e2f-88ec-e75f4beeabbd 0169-1834 HUMAN OTC DRUG Novolin N Human Insulin INJECTION, SUSPENSION SUBCUTANEOUS 19910701 NDA NDA019959 Novo Nordisk INSULIN HUMAN 100 [iU]/mL 0169-1837_6748f022-4f9d-42ea-9f82-e39abad34324 0169-1837 HUMAN OTC DRUG Novolin 70/30 Human Insulin INJECTION, SUSPENSION SUBCUTANEOUS 19910625 NDA NDA019991 Novo Nordisk INSULIN HUMAN 100 [USP'U]/mL 0169-3303_39c679b5-960c-4c65-8306-2cbb6a9469b2 0169-3303 HUMAN PRESCRIPTION DRUG NovoLog insulin aspart INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20010827 NDA NDA020986 Novo Nordisk INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0169-3685_68c8952b-8437-4efb-bf68-1cade071c2a2 0169-3685 HUMAN PRESCRIPTION DRUG NovoLog Mix 70/30 insulin aspart INJECTION, SUSPENSION SUBCUTANEOUS 20030210 NDA NDA021172 Novo Nordisk INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0169-3687_aa947266-e27c-432b-8e04-c36168d24ddb 0169-3687 HUMAN PRESCRIPTION DRUG Levemir insulin detemir INJECTION, SOLUTION SUBCUTANEOUS 20060327 NDA NDA021536 Novo Nordisk INSULIN DETEMIR 14.2 mg/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0169-3696_68c8952b-8437-4efb-bf68-1cade071c2a2 0169-3696 HUMAN PRESCRIPTION DRUG NovoLog Mix 70/30 insulin aspart INJECTION, SUSPENSION SUBCUTANEOUS 20020911 NDA NDA021172 Novo Nordisk INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0169-4060_49f302f5-f315-48b8-83a4-6ca56f01fded 0169-4060 HUMAN PRESCRIPTION DRUG Victoza liraglutide (rDNA origin) injection INJECTION, SOLUTION SUBCUTANEOUS 20100125 NDA NDA022341 Novo Nordisk LIRAGLUTIDE 6 mg/mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] 0169-5174_e0014a26-ea9d-4243-889b-b532a551abd0 0169-5174 HUMAN PRESCRIPTION DRUG Activella estradiol and norethindrone acetate TABLET, FILM COATED ORAL 20030722 NDA NDA020907 Novo Nordisk ESTRADIOL; NORETHINDRONE ACETATE 1; .5 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0169-5175_e0014a26-ea9d-4243-889b-b532a551abd0 0169-5175 HUMAN PRESCRIPTION DRUG Activella estradiol and norethindrone acetate TABLET, FILM COATED ORAL 20070409 NDA NDA020907 Novo Nordisk ESTRADIOL; NORETHINDRONE ACETATE .5; .1 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0169-5176_77f37e82-4a48-4c02-8c60-a011607408e6 0169-5176 HUMAN PRESCRIPTION DRUG Vagifem estradiol TABLET, FILM COATED VAGINAL 20100111 NDA NDA020908 Novo Nordisk ESTRADIOL 10 ug/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0169-6338_39c679b5-960c-4c65-8306-2cbb6a9469b2 0169-6338 HUMAN PRESCRIPTION DRUG NovoLog insulin aspart INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20131031 NDA NDA020986 Novo Nordisk INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0169-6339_39c679b5-960c-4c65-8306-2cbb6a9469b2 0169-6339 HUMAN PRESCRIPTION DRUG NovoLog insulin aspart INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20030122 NDA NDA020986 Novo Nordisk INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0169-6438_aa947266-e27c-432b-8e04-c36168d24ddb 0169-6438 HUMAN PRESCRIPTION DRUG Levemir insulin detemir INJECTION, SOLUTION SUBCUTANEOUS 20131031 NDA NDA021536 Novo Nordisk INSULIN DETEMIR 14.2 mg/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0169-6439_aa947266-e27c-432b-8e04-c36168d24ddb 0169-6439 HUMAN PRESCRIPTION DRUG Levemir insulin detemir INJECTION, SOLUTION SUBCUTANEOUS 20060327 NDA NDA021536 Novo Nordisk INSULIN DETEMIR 14.2 mg/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0169-7010_5015bee0-796f-44d3-9096-dfa62786eb2c 0169-7010 PLASMA DERIVATIVE NovoSeven RT Coagulation Factor VIIa (Recombinant) KIT 20080430 20150831 BLA BLA103665 Novo Nordisk 0169-7013_f4607f56-9618-4a12-a047-c0de02cafe05 0169-7013 PLASMA DERIVATIVE TRETTEN Coagulation Factor XIII A-Subunit (Recombinant) KIT 20131223 BLA BLA125398 Novo Nordisk 0169-7020_5015bee0-796f-44d3-9096-dfa62786eb2c 0169-7020 PLASMA DERIVATIVE NovoSeven RT Coagulation Factor VIIa (Recombinant) KIT 20080430 20150831 BLA BLA103665 Novo Nordisk 0169-7040_5015bee0-796f-44d3-9096-dfa62786eb2c 0169-7040 PLASMA DERIVATIVE NovoSeven RT Coagulation Factor VIIa (Recombinant) KIT 20100806 20150131 BLA BLA103665 Novo Nordisk 0169-7050_5015bee0-796f-44d3-9096-dfa62786eb2c 0169-7050 PLASMA DERIVATIVE NovoSeven RT Coagulation Factor VIIa (Recombinant) KIT 20080430 20151031 BLA BLA103665 Novo Nordisk 0169-7065_83b3a882-0d44-4e4b-bb1c-3756b39449c1 0169-7065 HUMAN PRESCRIPTION DRUG GlucaGen HypoKit glucagon hydrochloride KIT 20050622 NDA NDA020918 Novo Nordisk 0169-7201_5015bee0-796f-44d3-9096-dfa62786eb2c 0169-7201 PLASMA DERIVATIVE NovoSeven RT Coagulation Factor VIIa (Recombinant) KIT 20121029 BLA BLA103665 Novo Nordisk 0169-7202_5015bee0-796f-44d3-9096-dfa62786eb2c 0169-7202 PLASMA DERIVATIVE NovoSeven RT Coagulation Factor VIIa (Recombinant) KIT 20121029 BLA BLA103665 Novo Nordisk 0169-7205_5015bee0-796f-44d3-9096-dfa62786eb2c 0169-7205 PLASMA DERIVATIVE NovoSeven RT Coagulation Factor VIIa (Recombinant) KIT 20121029 BLA BLA103665 Novo Nordisk 0169-7208_5015bee0-796f-44d3-9096-dfa62786eb2c 0169-7208 PLASMA DERIVATIVE NovoSeven RT Coagulation Factor VIIa (Recombinant) KIT 20121029 BLA BLA103665 Novo Nordisk 0169-7501_39c679b5-960c-4c65-8306-2cbb6a9469b2 0169-7501 HUMAN PRESCRIPTION DRUG NovoLog insulin aspart INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20010827 NDA NDA020986 Novo Nordisk INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 0169-7703_42dfc5da-8aef-4f3e-9e4f-be162bc33862 0169-7703 HUMAN PRESCRIPTION DRUG Norditropin somatropin INJECTION, SOLUTION SUBCUTANEOUS 20090330 NDA NDA021148 Novo Nordisk SOMATROPIN 30 mg/3mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] 0169-7704_42dfc5da-8aef-4f3e-9e4f-be162bc33862 0169-7704 HUMAN PRESCRIPTION DRUG Norditropin somatropin INJECTION, SOLUTION SUBCUTANEOUS 20050103 NDA NDA021148 Novo Nordisk SOMATROPIN 5 mg/1.5mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] 0169-7705_42dfc5da-8aef-4f3e-9e4f-be162bc33862 0169-7705 HUMAN PRESCRIPTION DRUG Norditropin somatropin INJECTION, SOLUTION SUBCUTANEOUS 20060102 NDA NDA021148 Novo Nordisk SOMATROPIN 10 mg/1.5mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] 0169-7708_42dfc5da-8aef-4f3e-9e4f-be162bc33862 0169-7708 HUMAN PRESCRIPTION DRUG Norditropin somatropin INJECTION, SOLUTION SUBCUTANEOUS 20050103 NDA NDA021148 Novo Nordisk SOMATROPIN 15 mg/1.5mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] 0172-2083_aab6b305-de64-4d84-a332-d483dfdd9349 0172-2083 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19730112 ANDA ANDA083177 IVAX Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0172-2089_aab6b305-de64-4d84-a332-d483dfdd9349 0172-2089 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19800107 ANDA ANDA083177 IVAX Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0172-2662_41257a61-409b-4d51-8855-a78c21766010 0172-2662 HUMAN OTC DRUG FAMOTIDINE Famotidine TABLET ORAL 20100218 ANDA ANDA075512 IVAX Pharmaceuticals, Inc. FAMOTIDINE 10 mg/1 0172-2907_21153410-8a2b-44ce-814e-869571a199ae 0172-2907 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831130 NDA NDA018413 IVAX Pharmaceuticals, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0172-2908_21153410-8a2b-44ce-814e-869571a199ae 0172-2908 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831130 NDA NDA018413 IVAX Pharmaceuticals, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0172-3649_6479efda-0272-41cf-8760-872d92e8512a 0172-3649 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950912 20151031 ANDA ANDA074497 IVAX Pharmaceuticals Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0172-3650_6479efda-0272-41cf-8760-872d92e8512a 0172-3650 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950831 20151130 ANDA ANDA074497 IVAX Pharmaceuticals Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0172-3757_a41dabcc-6a91-46a1-bc8d-418c2ac7f56c 0172-3757 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075752 IVAX Pharmaceuticals, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0172-3758_a41dabcc-6a91-46a1-bc8d-418c2ac7f56c 0172-3758 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075752 IVAX Pharmaceuticals, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0172-3759_a41dabcc-6a91-46a1-bc8d-418c2ac7f56c 0172-3759 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075752 IVAX Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0172-3760_a41dabcc-6a91-46a1-bc8d-418c2ac7f56c 0172-3760 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075752 IVAX Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0172-3761_a41dabcc-6a91-46a1-bc8d-418c2ac7f56c 0172-3761 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075752 IVAX Pharmaceuticals, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0172-3762_a41dabcc-6a91-46a1-bc8d-418c2ac7f56c 0172-3762 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075752 IVAX Pharmaceuticals, Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0172-3925_f36dc0dd-c2ed-429a-8450-00ecbab1b3fd 0172-3925 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071307 IVAX Pharmaceuticals, Inc. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0172-3926_f36dc0dd-c2ed-429a-8450-00ecbab1b3fd 0172-3926 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071321 IVAX Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0172-3927_f36dc0dd-c2ed-429a-8450-00ecbab1b3fd 0172-3927 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071322 IVAX Pharmaceuticals, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0172-4096_70aa3223-0501-4615-9856-8891702b8829 0172-4096 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072234 IVAX Pharmaceuticals, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 0172-4097_70aa3223-0501-4615-9856-8891702b8829 0172-4097 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072235 IVAX Pharmaceuticals, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 0172-4280_3e922492-1a9c-4cae-bd70-cb26616291e4 0172-4280 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19920801 20150430 ANDA ANDA073568 IVAX Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0172-4285_3e922492-1a9c-4cae-bd70-cb26616291e4 0172-4285 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19971010 20150331 ANDA ANDA073568 IVAX Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0172-4286_3e922492-1a9c-4cae-bd70-cb26616291e4 0172-4286 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19920801 20150430 ANDA ANDA074330 IVAX Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0172-4357_ecc3f459-efc6-4281-bc61-b2cd092c492b 0172-4357 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 19970912 ANDA ANDA075165 IVAX Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0172-4358_ecc3f459-efc6-4281-bc61-b2cd092c492b 0172-4358 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 19980401 ANDA ANDA075165 IVAX Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0172-4364_0c430ad0-a284-45eb-815c-7c615b584840 0172-4364 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA074787 IVAX Pharmaceuticals, Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0172-4365_0c430ad0-a284-45eb-815c-7c615b584840 0172-4365 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA074787 IVAX Pharmaceuticals, Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0172-4366_0c430ad0-a284-45eb-815c-7c615b584840 0172-4366 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA074787 IVAX Pharmaceuticals, Inc. LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0172-4960_55c76073-6224-4470-9426-2d5446f0781d 0172-4960 HUMAN PRESCRIPTION DRUG Flutamide Flutamide CAPSULE ORAL 20010919 ANDA ANDA075780 IVAX Pharmaceuticals, Inc. FLUTAMIDE 125 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 0172-5032_c61dcfbf-cc83-4a62-b481-514a9458159d 0172-5032 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA075776 IVAX Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0172-5033_c61dcfbf-cc83-4a62-b481-514a9458159d 0172-5033 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA075776 IVAX Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0172-5034_c61dcfbf-cc83-4a62-b481-514a9458159d 0172-5034 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA075776 IVAX Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0172-5240_9cd94c50-53b5-46e4-b2f3-8198992bdc30 0172-5240 HUMAN PRESCRIPTION DRUG Anagrelide Hydrochloride Anagrelide Hydrochloride CAPSULE ORAL 20050418 ANDA ANDA076468 IVAX Pharmaceuticals, Inc. ANAGRELIDE HYDROCHLORIDE 1 mg/1 Decreased Platelet Production [PE],Platelet-reducing Agent [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0172-5241_9cd94c50-53b5-46e4-b2f3-8198992bdc30 0172-5241 HUMAN PRESCRIPTION DRUG Anagrelide Hydrochloride Anagrelide Hydrochloride CAPSULE ORAL 20050418 ANDA ANDA076468 IVAX Pharmaceuticals, Inc. ANAGRELIDE HYDROCHLORIDE .5 mg/1 Decreased Platelet Production [PE],Platelet-reducing Agent [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0172-5311_56ab4182-8a98-4246-a06e-f51a61114902 0172-5311 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076089 IVAX Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0172-5312_56ab4182-8a98-4246-a06e-f51a61114902 0172-5312 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076089 IVAX Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0172-5313_56ab4182-8a98-4246-a06e-f51a61114902 0172-5313 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076089 IVAX Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0172-5410_daf420cb-a429-48ed-a2dc-dca6447ff221 0172-5410 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 IVAX Pharmaceuticals, Inc. FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0172-5411_daf420cb-a429-48ed-a2dc-dca6447ff221 0172-5411 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 IVAX Pharmaceuticals, Inc. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0172-5412_daf420cb-a429-48ed-a2dc-dca6447ff221 0172-5412 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 IVAX Pharmaceuticals, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0172-5413_daf420cb-a429-48ed-a2dc-dca6447ff221 0172-5413 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 IVAX Pharmaceuticals, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0172-5728_eb3c8d4d-cabf-4a26-8453-7431e037a9b8 0172-5728 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075511 IVAX Pharmaceuticals, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0172-5729_eb3c8d4d-cabf-4a26-8453-7431e037a9b8 0172-5729 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075511 IVAX Pharmaceuticals, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0172-6406_1d16436b-c7df-4832-9e8f-552a7ef031e2 0172-6406 HUMAN PRESCRIPTION DRUG Cromolyn Sodium Cromolyn Sodium SOLUTION INTRABRONCHIAL 20000118 ANDA ANDA075271 IVAX Pharmaceuticals, Inc. CROMOLYN SODIUM 20 mg/2mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] 0172-7310_b1a54636-97b1-4221-bcf2-f6135a18dec9 0172-7310 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED ORAL 20050329 ANDA ANDA065110 IVAX Pharmaceuticals, Inc. CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0172-7311_b1a54636-97b1-4221-bcf2-f6135a18dec9 0172-7311 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED ORAL 20050428 ANDA ANDA065110 IVAX Pharmaceuticals, Inc. CYCLOSPORINE 50 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0172-7312_b1a54636-97b1-4221-bcf2-f6135a18dec9 0172-7312 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED ORAL 20050329 ANDA ANDA065110 IVAX Pharmaceuticals, Inc. CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0172-7313_f4635398-8059-4401-bf37-ca3d79d04114 0172-7313 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine SOLUTION ORAL 20050329 ANDA ANDA065078 IVAX Pharmaceuticals, Inc. CYCLOSPORINE 100 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0173-0135_b3617cfd-5110-4952-a2a6-de74e049ed9a 0173-0135 HUMAN PRESCRIPTION DRUG WELLBUTRIN SR bupropion hydrochloride TABLET, FILM COATED ORAL 19961115 NDA NDA020358 GlaxoSmithKline LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0173-0177_704ff5ae-01f7-402b-841e-9ea5450fa617 0173-0177 HUMAN PRESCRIPTION DRUG WELLBUTRIN bupropion hydrochloride TABLET, FILM COATED ORAL 19860204 NDA NDA018644 GlaxoSmithKline LLC BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0173-0178_704ff5ae-01f7-402b-841e-9ea5450fa617 0173-0178 HUMAN PRESCRIPTION DRUG WELLBUTRIN bupropion hydrochloride TABLET, FILM COATED ORAL 19890621 NDA NDA018644 GlaxoSmithKline LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0173-0242_e61563aa-d806-433a-9f31-4681516afa4e 0173-0242 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 19840914 20150930 NDA NDA020405 GlaxoSmithKline LLC DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0173-0249_e61563aa-d806-433a-9f31-4681516afa4e 0173-0249 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 19840702 20150930 NDA NDA020405 GlaxoSmithKline LLC DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0173-0344_2675f3d4-72e4-4abb-86b4-35b89f75a1cd 0173-0344 HUMAN PRESCRIPTION DRUG ZANTAC ranitidine hydrochloride TABLET, FILM COATED ORAL 19891001 NDA NDA018703 GlaxoSmithKline LLC RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0173-0387_d6d26f67-2e6f-4759-b18f-ff423f99e4c4 0173-0387 HUMAN PRESCRIPTION DRUG CEFTIN cefuroxime axetil TABLET, FILM COATED ORAL 19891001 NDA NDA050605 GlaxoSmithKline LLC CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0173-0388_a843e40e-ccff-4f4c-bc32-37a505143fba 0173-0388 HUMAN PRESCRIPTION DRUG BECONASE AQ beclomethasone dipropionate monohydrate SPRAY, SUSPENSION NASAL 19891001 NDA NDA019389 GlaxoSmithKline LLC BECLOMETHASONE DIPROPIONATE MONOHYDRATE 42 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0173-0393_2675f3d4-72e4-4abb-86b4-35b89f75a1cd 0173-0393 HUMAN PRESCRIPTION DRUG ZANTAC ranitidine hydrochloride TABLET, FILM COATED ORAL 19891001 NDA NDA018703 GlaxoSmithKline LLC RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0173-0394_d6d26f67-2e6f-4759-b18f-ff423f99e4c4 0173-0394 HUMAN PRESCRIPTION DRUG CEFTIN cefuroxime axetil TABLET, FILM COATED ORAL 19891001 NDA NDA050605 GlaxoSmithKline LLC CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0173-0442_4360408d-c087-4b68-8ee3-335b869d3694 0173-0442 HUMAN PRESCRIPTION DRUG ZOFRAN ondansetron hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19910204 NDA NDA020007 GlaxoSmithKline LLC ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0173-0446_ad059eb0-8aa8-4055-8191-7884b95bbc07 0173-0446 HUMAN PRESCRIPTION DRUG ZOFRAN ondansetron hydrochloride TABLET, FILM COATED ORAL 19930211 NDA NDA020103 GlaxoSmithKline LLC ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0173-0447_ad059eb0-8aa8-4055-8191-7884b95bbc07 0173-0447 HUMAN PRESCRIPTION DRUG ZOFRAN ondansetron hydrochloride TABLET, FILM COATED ORAL 19930211 NDA NDA020103 GlaxoSmithKline LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0173-0449_72a12b06-e610-4b35-9fcc-0db348d9d961 0173-0449 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate INJECTION SUBCUTANEOUS 19930223 NDA NDA020080 GlaxoSmithKline LLC SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0173-0453_d07f9265-8e86-4ed5-b0a9-8167d78b6322 0173-0453 HUMAN PRESCRIPTION DRUG FLONASE Fluticasone Propionate SPRAY, METERED NASAL 19941108 NDA NDA020121 GlaxoSmithKline LLC FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0173-0470_587b6f39-53c5-427b-8bf0-982ac963a790 0173-0470 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 19951121 20150616 NDA NDA020564 GlaxoSmithKline LLC LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0173-0478_72a12b06-e610-4b35-9fcc-0db348d9d961 0173-0478 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate INJECTION SUBCUTANEOUS 19970127 NDA NDA020080 GlaxoSmithKline LLC SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0173-0479_72a12b06-e610-4b35-9fcc-0db348d9d961 0173-0479 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate INJECTION SUBCUTANEOUS 19970123 NDA NDA020080 GlaxoSmithKline LLC SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0173-0489_ad059eb0-8aa8-4055-8191-7884b95bbc07 0173-0489 HUMAN PRESCRIPTION DRUG ZOFRAN ondansetron hydrochloride SOLUTION ORAL 19970205 NDA NDA020605 GlaxoSmithKline LLC ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0173-0517_15ae1260-2982-4d77-b070-d5bb80daed41 0173-0517 HUMAN PRESCRIPTION DRUG FLOLAN epoprostenol sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19951208 NDA NDA020444 GlaxoSmithKline LLC EPOPROSTENOL SODIUM .5 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] 0173-0519_15ae1260-2982-4d77-b070-d5bb80daed41 0173-0519 HUMAN PRESCRIPTION DRUG FLOLAN epoprostenol sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19951208 NDA NDA020444 GlaxoSmithKline LLC EPOPROSTENOL SODIUM 1.5 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] 0173-0520_5ca340cb-b60c-436c-8be1-e8c8fa119842 0173-0520 HUMAN PRESCRIPTION DRUG SEREVENT DISKUS salmeterol xinafoate POWDER, METERED ORAL; RESPIRATORY (INHALATION) 19971201 NDA NDA020692 GlaxoSmithKline LLC SALMETEROL XINAFOATE 50 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0173-0521_5ca340cb-b60c-436c-8be1-e8c8fa119842 0173-0521 HUMAN PRESCRIPTION DRUG SEREVENT DISKUS salmeterol xinafoate POWDER, METERED ORAL; RESPIRATORY (INHALATION) 19971125 NDA NDA020692 GlaxoSmithKline LLC SALMETEROL XINAFOATE 50 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0173-0523_3339da77-ebd3-418e-be54-d72879b17c53 0173-0523 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan SPRAY NASAL 19970918 NDA NDA020626 GlaxoSmithKline LLC SUMATRIPTAN 20 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0173-0524_3339da77-ebd3-418e-be54-d72879b17c53 0173-0524 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan SPRAY NASAL 19971010 NDA NDA020626 GlaxoSmithKline LLC SUMATRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0173-0526_0990b2e8-6353-44d8-a27a-dc62f18d44cd 0173-0526 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET, CHEWABLE ORAL 19980904 NDA NDA020764 GlaxoSmithKline LLC LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0527_0990b2e8-6353-44d8-a27a-dc62f18d44cd 0173-0527 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET, CHEWABLE ORAL 19980903 NDA NDA020764 GlaxoSmithKline LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0547_25ae0865-ade1-4c83-8742-07fd3d577fa0 0173-0547 HUMAN PRESCRIPTION DRUG MEPRON atovaquone SUSPENSION ORAL 19980918 NDA NDA020500 GlaxoSmithKline LLC ATOVAQUONE 750 mg/5mL Antimalarial [EPC],Antiprotozoal [EPC] 0173-0556_940c1fcb-3387-4c00-96cd-39b89d1852ba 0173-0556 HUMAN PRESCRIPTION DRUG ZYBAN bupropion hydrochloride TABLET, FILM COATED ORAL 19970528 NDA NDA020711 GlaxoSmithKline LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0173-0561_617d474f-b9e7-45f5-b368-1adb63821bef 0173-0561 HUMAN PRESCRIPTION DRUG AMERGE naratriptan hydrochloride TABLET, FILM COATED ORAL 19980226 NDA NDA020763 GlaxoSmithKline LLC NARATRIPTAN HYDROCHLORIDE 1 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0173-0562_617d474f-b9e7-45f5-b368-1adb63821bef 0173-0562 HUMAN PRESCRIPTION DRUG AMERGE naratriptan hydrochloride TABLET, FILM COATED ORAL 19980226 NDA NDA020763 GlaxoSmithKline LLC NARATRIPTAN HYDROCHLORIDE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0173-0565_6f08354b-781c-4d6e-ac8a-33930c5ee663 0173-0565 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 20020812 NDA NDA020487 GlaxoSmithKline LLC VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0173-0569_ad059eb0-8aa8-4055-8191-7884b95bbc07 0173-0569 HUMAN PRESCRIPTION DRUG ZOFRAN ODT ondansetron hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 19990301 NDA NDA020781 GlaxoSmithKline LLC ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0173-0570_ad059eb0-8aa8-4055-8191-7884b95bbc07 0173-0570 HUMAN PRESCRIPTION DRUG ZOFRAN ODT ondansetron hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 19990301 NDA NDA020781 GlaxoSmithKline LLC ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0173-0594_0990b2e8-6353-44d8-a27a-dc62f18d44cd 0173-0594 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine KIT 20030929 NDA NDA020241 GlaxoSmithKline LLC 0173-0600_5d9e5eda-5954-4b82-b848-150bbcfb6902 0173-0600 HUMAN PRESCRIPTION DRUG FLOVENT DISKUS fluticasone propionate POWDER, METERED RESPIRATORY (INHALATION) 20070508 NDA NDA020833 GlaxoSmithKline LLC FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0173-0601_5d9e5eda-5954-4b82-b848-150bbcfb6902 0173-0601 HUMAN PRESCRIPTION DRUG FLOVENT DISKUS fluticasone propionate POWDER, METERED RESPIRATORY (INHALATION) 20081013 NDA NDA020833 GlaxoSmithKline LLC FLUTICASONE PROPIONATE 250 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0173-0602_5d9e5eda-5954-4b82-b848-150bbcfb6902 0173-0602 HUMAN PRESCRIPTION DRUG FLOVENT DISKUS fluticasone propionate POWDER, METERED RESPIRATORY (INHALATION) 20081013 NDA NDA020833 GlaxoSmithKline LLC FLUTICASONE PROPIONATE 100 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0173-0633_0990b2e8-6353-44d8-a27a-dc62f18d44cd 0173-0633 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 19960815 NDA NDA020241 GlaxoSmithKline LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0642_0990b2e8-6353-44d8-a27a-dc62f18d44cd 0173-0642 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 19950117 NDA NDA020241 GlaxoSmithKline LLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0643_0990b2e8-6353-44d8-a27a-dc62f18d44cd 0173-0643 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 19950117 NDA NDA020241 GlaxoSmithKline LLC LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0644_0990b2e8-6353-44d8-a27a-dc62f18d44cd 0173-0644 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 19950118 NDA NDA020241 GlaxoSmithKline LLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0662_a69be4c0-907d-4ccb-93fa-a49f28708720 0173-0662 HUMAN PRESCRIPTION DRUG EPIVIR HBV lamivudine TABLET, FILM COATED ORAL 19981217 NDA NDA021003 GlaxoSmithKline LLC LAMIVUDINE 100 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0173-0663_a69be4c0-907d-4ccb-93fa-a49f28708720 0173-0663 HUMAN PRESCRIPTION DRUG EPIVIR HBV lamivudine SOLUTION ORAL 19981223 NDA NDA021004 GlaxoSmithKline LLC LAMIVUDINE 5 mg/mL Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0173-0665_25ae0865-ade1-4c83-8742-07fd3d577fa0 0173-0665 HUMAN PRESCRIPTION DRUG MEPRON atovaquone SUSPENSION ORAL 19950228 NDA NDA020500 GlaxoSmithKline LLC ATOVAQUONE 750 mg/5mL Antimalarial [EPC],Antiprotozoal [EPC] 0173-0675_9aa63f55-cb37-46ec-9e91-7559ef46994e 0173-0675 HUMAN PRESCRIPTION DRUG MALARONE atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20000726 NDA NDA021078 GlaxoSmithKline LLC ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 0173-0676_9aa63f55-cb37-46ec-9e91-7559ef46994e 0173-0676 HUMAN PRESCRIPTION DRUG MALARONE atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20000726 NDA NDA021078 GlaxoSmithKline LLC ATOVAQUONE; PROGUANIL HYDROCHLORIDE 62.5; 25 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 0173-0681_8fd08cf0-9854-4213-9471-e7160c67ac9c 0173-0681 HUMAN PRESCRIPTION DRUG RELENZA zanamivir POWDER RESPIRATORY (INHALATION) 19990922 NDA NDA021036 GlaxoSmithKline LLC ZANAMIVIR 5 mg/1 Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] 0173-0682_1f282bc3-1973-4fb1-a911-49202f177da0 0173-0682 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 GlaxoSmithKline LLC ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0173-0695_71ce10d8-bcc1-4c7a-8d43-7ccdf88481b7 0173-0695 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20010228 NDA NDA021077 GlaxoSmithKline LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 100; 50 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0173-0696_71ce10d8-bcc1-4c7a-8d43-7ccdf88481b7 0173-0696 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20010205 NDA NDA021077 GlaxoSmithKline LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 250; 50 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0173-0697_71ce10d8-bcc1-4c7a-8d43-7ccdf88481b7 0173-0697 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20010305 NDA NDA021077 GlaxoSmithKline LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 500; 50 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0173-0699_0990b2e8-6353-44d8-a27a-dc62f18d44cd 0173-0699 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET, CHEWABLE ORAL 20001012 NDA NDA020764 GlaxoSmithKline LLC LAMOTRIGINE 2 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0712_f4e01a17-e1b4-4969-9e91-7d9efb39cba0 0173-0712 HUMAN PRESCRIPTION DRUG AVODART dutasteride CAPSULE, LIQUID FILLED ORAL 20021210 NDA NDA021319 GlaxoSmithKline LLC DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 0173-0715_935e0af6-448e-493f-a55d-b56059027946 0173-0715 HUMAN PRESCRIPTION DRUG ADVAIR HFA fluticasone propionate and salmeterol xinafoate AEROSOL, METERED RESPIRATORY (INHALATION) 20080929 NDA NDA021254 GlaxoSmithKline LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 45; 21 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0173-0716_935e0af6-448e-493f-a55d-b56059027946 0173-0716 HUMAN PRESCRIPTION DRUG ADVAIR HFA fluticasone propionate and salmeterol xinafoate AEROSOL, METERED RESPIRATORY (INHALATION) 20080929 NDA NDA021254 GlaxoSmithKline LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 115; 21 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0173-0717_935e0af6-448e-493f-a55d-b56059027946 0173-0717 HUMAN PRESCRIPTION DRUG ADVAIR HFA fluticasone propionate and salmeterol xinafoate AEROSOL, METERED RESPIRATORY (INHALATION) 20090306 NDA NDA021254 GlaxoSmithKline LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 230; 21 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0173-0718_443d255d-e170-4610-af78-bc7ce9f0ab18 0173-0718 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20070406 NDA NDA021433 GlaxoSmithKline LLC FLUTICASONE PROPIONATE 44 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0173-0719_443d255d-e170-4610-af78-bc7ce9f0ab18 0173-0719 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20070129 NDA NDA021433 GlaxoSmithKline LLC FLUTICASONE PROPIONATE 110 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0173-0720_443d255d-e170-4610-af78-bc7ce9f0ab18 0173-0720 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20070125 NDA NDA021433 GlaxoSmithKline LLC FLUTICASONE PROPIONATE 220 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0173-0722_b3617cfd-5110-4952-a2a6-de74e049ed9a 0173-0722 HUMAN PRESCRIPTION DRUG WELLBUTRIN SR bupropion hydrochloride TABLET, FILM COATED ORAL 20020625 NDA NDA020358 GlaxoSmithKline LLC BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0173-0735_d1893ba6-3bf4-4aa2-8dae-6346127462d5 0173-0735 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate TABLET, FILM COATED ORAL 20031217 NDA NDA020132 GlaxoSmithKline LLC SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0173-0736_d1893ba6-3bf4-4aa2-8dae-6346127462d5 0173-0736 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate TABLET, FILM COATED ORAL 20031217 NDA NDA020132 GlaxoSmithKline LLC SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0173-0737_d1893ba6-3bf4-4aa2-8dae-6346127462d5 0173-0737 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate TABLET, FILM COATED ORAL 20031219 NDA NDA020132 GlaxoSmithKline LLC SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0173-0739_72a12b06-e610-4b35-9fcc-0db348d9d961 0173-0739 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate INJECTION SUBCUTANEOUS 20060406 NDA NDA020080 GlaxoSmithKline LLC SUMATRIPTAN SUCCINATE 4 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0173-0740_d6d26f67-2e6f-4759-b18f-ff423f99e4c4 0173-0740 HUMAN PRESCRIPTION DRUG CEFTIN cefuroxime axetil POWDER, FOR SUSPENSION ORAL 20040602 NDA NDA050672 GlaxoSmithKline LLC CEFUROXIME AXETIL 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0173-0741_d6d26f67-2e6f-4759-b18f-ff423f99e4c4 0173-0741 HUMAN PRESCRIPTION DRUG CEFTIN cefuroxime axetil POWDER, FOR SUSPENSION ORAL 20040602 NDA NDA050672 GlaxoSmithKline LLC CEFUROXIME AXETIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0173-0750_7d7039dc-ac30-470f-b434-0631c55f94f5 0173-0750 HUMAN PRESCRIPTION DRUG TREXIMET sumatriptan and naproxen sodium TABLET, FILM COATED ORAL 20080425 NDA NDA021926 GlaxoSmithKline LLC NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE 500; 85 mg/1; mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0173-0752_5f8f09cc-3882-45f1-9572-e896b5338119 0173-0752 HUMAN PRESCRIPTION DRUG TYKERB lapatinib TABLET ORAL 20070316 NDA NDA022059 GlaxoSmithKline LLC LAPATINIB DITOSYLATE 250 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0173-0753_8cb644e1-333f-46f8-bfde-e47966ef2326 0173-0753 HUMAN PRESCRIPTION DRUG VERAMYST fluticasone furoate SPRAY, METERED NASAL 20070515 NDA NDA022051 GlaxoSmithKline LLC FLUTICASONE FUROATE 27.5 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0173-0754_cc987b62-cf1f-48e4-96a8-bc732b585e60 0173-0754 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090706 NDA NDA022115 GlaxoSmithKline LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0755_cc987b62-cf1f-48e4-96a8-bc732b585e60 0173-0755 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090706 NDA NDA022115 GlaxoSmithKline LLC LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0756_cc987b62-cf1f-48e4-96a8-bc732b585e60 0173-0756 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090706 NDA NDA022115 GlaxoSmithKline LLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0757_cc987b62-cf1f-48e4-96a8-bc732b585e60 0173-0757 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090706 NDA NDA022115 GlaxoSmithKline LLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0758_cc987b62-cf1f-48e4-96a8-bc732b585e60 0173-0758 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine KIT 20090706 NDA NDA022115 GlaxoSmithKline LLC 0173-0759_cc987b62-cf1f-48e4-96a8-bc732b585e60 0173-0759 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine KIT 20090706 NDA NDA022115 GlaxoSmithKline LLC 0173-0760_cc987b62-cf1f-48e4-96a8-bc732b585e60 0173-0760 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine KIT 20090706 NDA NDA022115 GlaxoSmithKline LLC 0173-0761_cc987b62-cf1f-48e4-96a8-bc732b585e60 0173-0761 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110331 NDA NDA022115 GlaxoSmithKline LLC LAMOTRIGINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0772_0990b2e8-6353-44d8-a27a-dc62f18d44cd 0173-0772 HUMAN PRESCRIPTION DRUG LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20090605 NDA NDA022251 GlaxoSmithKline LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0774_0990b2e8-6353-44d8-a27a-dc62f18d44cd 0173-0774 HUMAN PRESCRIPTION DRUG LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20090605 NDA NDA022251 GlaxoSmithKline LLC LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0776_0990b2e8-6353-44d8-a27a-dc62f18d44cd 0173-0776 HUMAN PRESCRIPTION DRUG LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20090605 NDA NDA022251 GlaxoSmithKline LLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0777_0990b2e8-6353-44d8-a27a-dc62f18d44cd 0173-0777 HUMAN PRESCRIPTION DRUG LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20090605 NDA NDA022251 GlaxoSmithKline LLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0778_0990b2e8-6353-44d8-a27a-dc62f18d44cd 0173-0778 HUMAN PRESCRIPTION DRUG LAMICTAL ODT lamotrigine KIT 20090605 NDA NDA022251 GlaxoSmithKline LLC 0173-0779_0990b2e8-6353-44d8-a27a-dc62f18d44cd 0173-0779 HUMAN PRESCRIPTION DRUG LAMICTAL ODT lamotrigine KIT 20090605 NDA NDA022251 GlaxoSmithKline LLC 0173-0780_0990b2e8-6353-44d8-a27a-dc62f18d44cd 0173-0780 HUMAN PRESCRIPTION DRUG LAMICTAL ODT lamotrigine KIT 20090605 NDA NDA022251 GlaxoSmithKline LLC 0173-0781_cc987b62-cf1f-48e4-96a8-bc732b585e60 0173-0781 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110815 NDA NDA022115 GlaxoSmithKline LLC LAMOTRIGINE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0173-0783_6640f842-2b68-4ff4-a52d-d27d546911e8 0173-0783 HUMAN PRESCRIPTION DRUG LOVAZA omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20081021 NDA NDA021654 GlaxoSmithKline LLC OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] 0173-0790_c6145160-5166-4278-b2b7-3607a343da93 0173-0790 HUMAN PRESCRIPTION DRUG INNOPRAN XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20080328 20150714 NDA NDA021438 GlaxoSmithKline LLC PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0173-0791_c6145160-5166-4278-b2b7-3607a343da93 0173-0791 HUMAN PRESCRIPTION DRUG INNOPRAN XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20080328 20150713 NDA NDA021438 GlaxoSmithKline LLC PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0173-0792_1c46c0a6-be8c-451c-a115-578b86651f17 0173-0792 HUMAN PRESCRIPTION DRUG RYTHMOL propafenone hydrochloride TABLET, FILM COATED ORAL 20100104 NDA NDA019151 GlaxoSmithKline LLC PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] 0173-0794_1c46c0a6-be8c-451c-a115-578b86651f17 0173-0794 HUMAN PRESCRIPTION DRUG RYTHMOL propafenone hydrochloride TABLET, FILM COATED ORAL 20100104 NDA NDA019151 GlaxoSmithKline LLC PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] 0173-0804_f22eca01-11d3-4225-abd4-01c3e2be15ca 0173-0804 HUMAN PRESCRIPTION DRUG VOTRIENT pazopanib hydrochloride TABLET, FILM COATED ORAL 20091019 NDA NDA022465 GlaxoSmithKline LLC PAZOPANIB HYDROCHLORIDE 200 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] 0173-0809_38b0bddc-6069-4f4a-b4a5-0710df70f0b4 0173-0809 HUMAN PRESCRIPTION DRUG JALYN dutasteride and tamsulosin hydrochloride CAPSULE ORAL 20100621 NDA NDA022460 GlaxoSmithKline LLC DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE .5; .4 mg/1; mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA],Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0173-0810_d60735e5-1f96-4af4-ac42-9fc4f976aaf0 0173-0810 HUMAN PRESCRIPTION DRUG POTIGA ezogabine TABLET, FILM COATED ORAL 20120419 NDA NDA022345 GlaxoSmithKline LLC EZOGABINE 50 mg/1 Potassium Channel Openers [MoA],Potassium Channel Opener [EPC] CV 0173-0812_d60735e5-1f96-4af4-ac42-9fc4f976aaf0 0173-0812 HUMAN PRESCRIPTION DRUG POTIGA ezogabine TABLET, FILM COATED ORAL 20120419 NDA NDA022345 GlaxoSmithKline LLC EZOGABINE 200 mg/1 Potassium Channel Openers [MoA],Potassium Channel Opener [EPC] CV 0173-0813_d60735e5-1f96-4af4-ac42-9fc4f976aaf0 0173-0813 HUMAN PRESCRIPTION DRUG POTIGA ezogabine TABLET, FILM COATED ORAL 20120419 NDA NDA022345 GlaxoSmithKline LLC EZOGABINE 300 mg/1 Potassium Channel Openers [MoA],Potassium Channel Opener [EPC] CV 0173-0814_d60735e5-1f96-4af4-ac42-9fc4f976aaf0 0173-0814 HUMAN PRESCRIPTION DRUG POTIGA ezogabine TABLET, FILM COATED ORAL 20120419 NDA NDA022345 GlaxoSmithKline LLC EZOGABINE 400 mg/1 Potassium Channel Openers [MoA],Potassium Channel Opener [EPC] CV 0173-0817_0990b2e8-6353-44d8-a27a-dc62f18d44cd 0173-0817 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine KIT 20030929 NDA NDA020241 GlaxoSmithKline LLC 0173-0821_d04f1e34-9f93-4e92-a20f-6b5e509f83b5 0173-0821 HUMAN PRESCRIPTION DRUG ARZERRA ofatumumab INJECTION, SOLUTION INTRAVENOUS 20110722 BLA BLA125326 GlaxoSmithKline LLC OFATUMUMAB 20 mg/mL CD20-directed Cytolytic Antibody [EPC],CD20-directed Antibody Interactions [MoA] 0173-0822_214a2cd8-06ce-443a-8eb7-818147eb90e6 0173-0822 HUMAN PRESCRIPTION DRUG Staxyn vardenafil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20110421 NDA NDA200179 GlaxoSmithKline LLC VARDENAFIL HYDROCHLORIDE TRIHYDRATE 11.85 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0173-0823_15ba165d-f71d-4ac8-a4ec-186f470ab340 0173-0823 HUMAN PRESCRIPTION DRUG RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110317 NDA NDA021416 GlaxoSmithKline LLC PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] 0173-0824_15ba165d-f71d-4ac8-a4ec-186f470ab340 0173-0824 HUMAN PRESCRIPTION DRUG RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110317 NDA NDA021416 GlaxoSmithKline LLC PROPAFENONE HYDROCHLORIDE 325 mg/1 Antiarrhythmic [EPC] 0173-0826_15ba165d-f71d-4ac8-a4ec-186f470ab340 0173-0826 HUMAN PRESCRIPTION DRUG RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110317 NDA NDA021416 GlaxoSmithKline LLC PROPAFENONE HYDROCHLORIDE 425 mg/1 Antiarrhythmic [EPC] 0173-0828_f79999a9-4429-4947-b12e-02e7b9952b90 0173-0828 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20030825 NDA NDA021400 GlaxoSmithKline LLC VARDENAFIL HYDROCHLORIDE TRIHYDRATE 2.5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0173-0829_f79999a9-4429-4947-b12e-02e7b9952b90 0173-0829 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20030423 NDA NDA021400 GlaxoSmithKline LLC VARDENAFIL HYDROCHLORIDE TRIHYDRATE 5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0173-0830_f79999a9-4429-4947-b12e-02e7b9952b90 0173-0830 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20030825 NDA NDA021400 GlaxoSmithKline LLC VARDENAFIL HYDROCHLORIDE TRIHYDRATE 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0173-0831_f79999a9-4429-4947-b12e-02e7b9952b90 0173-0831 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20030825 NDA NDA021400 GlaxoSmithKline LLC VARDENAFIL HYDROCHLORIDE TRIHYDRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0173-0834_168aae8d-e4e7-4b3e-bd76-5235afc8e869 0173-0834 HUMAN PRESCRIPTION DRUG AVANDIA rosiglitazone maleate TABLET, FILM COATED ORAL 20110525 NDA NDA021071 GlaxoSmithKline LLC ROSIGLITAZONE MALEATE 2 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0173-0835_168aae8d-e4e7-4b3e-bd76-5235afc8e869 0173-0835 HUMAN PRESCRIPTION DRUG AVANDIA rosiglitazone maleate TABLET, FILM COATED ORAL 20110525 NDA NDA021071 GlaxoSmithKline LLC ROSIGLITAZONE MALEATE 4 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0173-0836_168aae8d-e4e7-4b3e-bd76-5235afc8e869 0173-0836 HUMAN PRESCRIPTION DRUG AVANDIA rosiglitazone maleate TABLET, FILM COATED ORAL 20110525 NDA NDA021071 GlaxoSmithKline LLC ROSIGLITAZONE MALEATE 8 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0173-0837_0aff9421-a65a-4006-b67f-c33558deb87f 0173-0837 HUMAN PRESCRIPTION DRUG AVANDAMET rosiglitazone maleate and metformin hydrochloride TABLET, FILM COATED ORAL 20110524 NDA NDA021410 GlaxoSmithKline LLC METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 500; 2 mg/1; mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0173-0838_0aff9421-a65a-4006-b67f-c33558deb87f 0173-0838 HUMAN PRESCRIPTION DRUG AVANDAMET rosiglitazone maleate and metformin hydrochloride TABLET, FILM COATED ORAL 20110524 NDA NDA021410 GlaxoSmithKline LLC METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 1000; 2 mg/1; mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0173-0839_0aff9421-a65a-4006-b67f-c33558deb87f 0173-0839 HUMAN PRESCRIPTION DRUG AVANDAMET rosiglitazone maleate and metformin hydrochloride TABLET, FILM COATED ORAL 20110524 NDA NDA021410 GlaxoSmithKline LLC METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 500; 4 mg/1; mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0173-0840_0aff9421-a65a-4006-b67f-c33558deb87f 0173-0840 HUMAN PRESCRIPTION DRUG AVANDAMET rosiglitazone maleate and metformin hydrochloride TABLET, FILM COATED ORAL 20110524 NDA NDA021410 GlaxoSmithKline LLC METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 1000; 4 mg/1; mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0173-0841_a3822ef2-d7ec-4288-8151-bc1a7a635bd8 0173-0841 HUMAN PRESCRIPTION DRUG AVANDARYL rosiglitazone maleate and glimepiride TABLET, FILM COATED ORAL 20110524 NDA NDA021700 GlaxoSmithKline LLC GLIMEPIRIDE; ROSIGLITAZONE MALEATE 1; 4 mg/1; mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0173-0842_a3822ef2-d7ec-4288-8151-bc1a7a635bd8 0173-0842 HUMAN PRESCRIPTION DRUG AVANDARYL rosiglitazone maleate and glimepiride TABLET, FILM COATED ORAL 20110524 NDA NDA021700 GlaxoSmithKline LLC GLIMEPIRIDE; ROSIGLITAZONE MALEATE 2; 4 mg/1; mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0173-0843_a3822ef2-d7ec-4288-8151-bc1a7a635bd8 0173-0843 HUMAN PRESCRIPTION DRUG AVANDARYL rosiglitazone maleate and glimepiride TABLET, FILM COATED ORAL 20110524 NDA NDA021700 GlaxoSmithKline LLC GLIMEPIRIDE; ROSIGLITAZONE MALEATE 4; 4 mg/1; mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0173-0844_a3822ef2-d7ec-4288-8151-bc1a7a635bd8 0173-0844 HUMAN PRESCRIPTION DRUG AVANDARYL rosiglitazone maleate and glimepiride TABLET, FILM COATED ORAL 20110524 NDA NDA021700 GlaxoSmithKline LLC GLIMEPIRIDE; ROSIGLITAZONE MALEATE 2; 8 mg/1; mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0173-0845_a3822ef2-d7ec-4288-8151-bc1a7a635bd8 0173-0845 HUMAN PRESCRIPTION DRUG AVANDARYL rosiglitazone maleate and glimepiride TABLET, FILM COATED ORAL 20110524 NDA NDA021700 GlaxoSmithKline LLC GLIMEPIRIDE; ROSIGLITAZONE MALEATE 4; 8 mg/1; mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0173-0846_452c857a-25ea-44c7-95e5-ed8e984c5dbc 0173-0846 HUMAN PRESCRIPTION DRUG Tafinlar dabrafenib CAPSULE ORAL 20130610 NDA NDA202806 GlaxoSmithKline LLC DABRAFENIB MESYLATE 50 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Organic Anion Transporter 1 Inhibitors [MoA],Organic Anion Transporter 3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] 0173-0847_452c857a-25ea-44c7-95e5-ed8e984c5dbc 0173-0847 HUMAN PRESCRIPTION DRUG Tafinlar dabrafenib CAPSULE ORAL 20130610 NDA NDA202806 GlaxoSmithKline LLC DABRAFENIB MESYLATE 75 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Organic Anion Transporter 1 Inhibitors [MoA],Organic Anion Transporter 3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] 0173-0848_6bc39f93-3959-4ac9-93bd-daf2aee3c47c 0173-0848 HUMAN PRESCRIPTION DRUG Mekinist trametinib TABLET, FILM COATED ORAL 20130617 NDA NDA204114 GlaxoSmithKline LLC TRAMETINIB DIMETHYL SULFOXIDE 2 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0173-0849_6bc39f93-3959-4ac9-93bd-daf2aee3c47c 0173-0849 HUMAN PRESCRIPTION DRUG Mekinist trametinib TABLET, FILM COATED ORAL 20130617 NDA NDA204114 GlaxoSmithKline LLC TRAMETINIB DIMETHYL SULFOXIDE .5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0173-0858_6bc39f93-3959-4ac9-93bd-daf2aee3c47c 0173-0858 HUMAN PRESCRIPTION DRUG Mekinist trametinib TABLET, FILM COATED ORAL 20130617 NDA NDA204114 GlaxoSmithKline LLC TRAMETINIB DIMETHYL SULFOXIDE 1 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0173-0859_347cdf04-17b7-47b0-8ae3-58034e5c62bc 0173-0859 HUMAN PRESCRIPTION DRUG Breo Ellipta fluticasone furoate and vilanterol trifenatate POWDER RESPIRATORY (INHALATION) 20130826 NDA NDA204275 GlaxoSmithKline LLC FLUTICASONE FUROATE; VILANTEROL TRIFENATATE 100; 25 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0173-0861_168aae8d-e4e7-4b3e-bd76-5235afc8e869 0173-0861 HUMAN PRESCRIPTION DRUG AVANDIA 2MG rosiglitazone maleate TABLET, FILM COATED ORAL 20110525 NDA NDA021071 GlaxoSmithKline LLC ROSIGLITAZONE MALEATE 2 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0173-0863_168aae8d-e4e7-4b3e-bd76-5235afc8e869 0173-0863 HUMAN PRESCRIPTION DRUG AVANDIA 4MG rosiglitazone maleate TABLET, FILM COATED ORAL 20110525 NDA NDA021071 GlaxoSmithKline LLC ROSIGLITAZONE MALEATE 4 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0173-0864_168aae8d-e4e7-4b3e-bd76-5235afc8e869 0173-0864 HUMAN PRESCRIPTION DRUG AVANDIA 8MG rosiglitazone maleate TABLET, FILM COATED ORAL 20110525 NDA NDA021071 GlaxoSmithKline LLC ROSIGLITAZONE MALEATE 8 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0173-0866_27cc3fd9-8827-4479-8d31-ef4b88ee348c 0173-0866 HUMAN PRESCRIPTION DRUG Tanzeum albiglutide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20140415 BLA BLA125431 GlaxoSmithKline LLC ALBIGLUTIDE 30 mg/.5mL GLP-1 Receptor Agonist [EPC],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] 0173-0867_27cc3fd9-8827-4479-8d31-ef4b88ee348c 0173-0867 HUMAN PRESCRIPTION DRUG Tanzeum albiglutide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20140415 BLA BLA125431 GlaxoSmithKline LLC ALBIGLUTIDE 50 mg/.5mL GLP-1 Receptor Agonist [EPC],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] 0173-0869_e5613536-2962-46fa-a375-fdd2473087c4 0173-0869 HUMAN PRESCRIPTION DRUG Anoro Ellipta umeclidinium bromide and vilanterol trifenatate POWDER RESPIRATORY (INHALATION) 20140131 NDA NDA203975 GlaxoSmithKline LLC UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE 62.5; 25 ug/1; ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0173-0873_6cbc3aa5-2ac7-47a3-9551-3e5836b71150 0173-0873 HUMAN PRESCRIPTION DRUG Incruse Ellipta umeclidinium AEROSOL, POWDER ORAL 20140430 NDA NDA205382 GlaxoSmithKline LLC UMECLIDINIUM BROMIDE 62.5 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0173-0874_8dfb55d2-4b85-4749-8edb-f79e8d336654 0173-0874 HUMAN PRESCRIPTION DRUG Arnuity Ellipta fluticasone furoate POWDER RESPIRATORY (INHALATION) 20140820 NDA NDA205625 GlaxoSmithKline LLC FLUTICASONE FUROATE 100 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0173-0876_8dfb55d2-4b85-4749-8edb-f79e8d336654 0173-0876 HUMAN PRESCRIPTION DRUG Arnuity Ellipta fluticasone furoate POWDER RESPIRATORY (INHALATION) 20140820 NDA NDA205625 GlaxoSmithKline LLC FLUTICASONE FUROATE 200 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0173-0933_6f08354b-781c-4d6e-ac8a-33930c5ee663 0173-0933 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 19950801 NDA NDA020487 GlaxoSmithKline LLC VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0173-0947_b3617cfd-5110-4952-a2a6-de74e049ed9a 0173-0947 HUMAN PRESCRIPTION DRUG WELLBUTRIN SR bupropion hydrochloride TABLET, FILM COATED ORAL 19961115 NDA NDA020358 GlaxoSmithKline LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0173-0949_37b68080-e4bc-42f3-82fd-e8dd38b5507a 0173-0949 HUMAN PRESCRIPTION DRUG ZOVIRAX acyclovir TABLET ORAL 19930729 20150613 NDA NDA020089 GlaxoSmithKline LLC ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0173-0953_37b68080-e4bc-42f3-82fd-e8dd38b5507a 0173-0953 HUMAN PRESCRIPTION DRUG ZOVIRAX acyclovir SUSPENSION ORAL 19900402 20150531 NDA NDA019909 GlaxoSmithKline LLC ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0178-0089_a2e8c52c-2004-4474-8ed8-bd77e71ef3df 0178-0089 HUMAN PRESCRIPTION DRUG Ferralet 90 Iron, Folic Acid, Cyanocobalamin, Ascorbic acid, and Docusate Sodium TABLET, FILM COATED ORAL 20100204 UNAPPROVED DRUG OTHER Mission Pharmacal Company ASCORBIC ACID; CYANOCOBALAMIN; DOCUSATE SODIUM; FOLIC ACID; IRON 120; 12; 50; 1; 90 mg/1; ug/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 0178-0101_96e6578c-a8e7-78ce-1ed2-62dccaa6c6f7 0178-0101 HUMAN PRESCRIPTION DRUG Binosto alendronate sodium TABLET, EFFERVESCENT ORAL 20120903 NDA NDA202344 Mission Pharmacal Company ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0178-0320_db6c0c77-0a20-d574-a98f-e6c9998b941f 0178-0320 HUMAN OTC DRUG Theragesic Creme METHYL SALICYLATE GEL TOPICAL 19810101 OTC MONOGRAPH NOT FINAL part348 Mission Pharmacal Company MENTHOL; METHYL SALICYLATE 10; 150 mg/g; mg/g 0178-0330_4d549c7e-8e66-48c0-98f2-a63fd613bf52 0178-0330 HUMAN OTC DRUG DR SMITHS DIAPER zinc oxide OINTMENT TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part347 Mission Pharmacal ZINC OXIDE 8.5 g/85g 0178-0340_213e239e-3f3a-b35d-c024-17cbd88bc1ee 0178-0340 HUMAN OTC DRUG Dr Smiths Diaper Rash Zinc Oxide SPRAY TOPICAL 20140407 OTC MONOGRAPH FINAL part347 Mission Pharmacal Company ZINC OXIDE 10 g/100g 0178-0345_0a6b5d7c-e58c-a07a-392a-3bac2a390602 0178-0345 HUMAN OTC DRUG Dr Smiths Diaper Rash Zinc Oxide SPRAY TOPICAL 20140407 OTC MONOGRAPH FINAL part347 Mission Pharmacal Company ZINC OXIDE 10 g/100g 0178-0348_9e809b5f-6930-6871-b309-fd2cd8d59c50 0178-0348 HUMAN OTC DRUG Dr Smiths Diaper Rash Zinc Oxide SPRAY TOPICAL 20140407 OTC MONOGRAPH FINAL part347 Mission Pharmacal Company ZINC OXIDE 10 g/100g 0178-0350_6e7bccc8-1823-4b45-d047-f0979a8e0443 0178-0350 HUMAN OTC DRUG Theragesic Plus METHYL SALICYLATE GEL TOPICAL 19810101 OTC MONOGRAPH NOT FINAL part348 Mission Pharmacal Company MENTHOL; METHYL SALICYLATE 40; 250 mg/g; mg/g 0178-0370_e6e61eea-73a0-3936-c648-b87771c24102 0178-0370 HUMAN OTC DRUG Dr. Smiths Rash and Skin Zinc Oxide OINTMENT TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 Mission Pharmacal Company ZINC OXIDE 10 g/100g 0178-0455_2915df51-4fbd-41ee-ac57-cb302593fb6d 0178-0455 HUMAN PRESCRIPTION DRUG Texacort Hydrocortisone SOLUTION TOPICAL 20111215 ANDA ANDA081271 Mission Pharmacal Company HYDROCORTISONE 25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0178-0460_8954e2cb-584e-4600-8fef-db28013047f2 0178-0460 HUMAN PRESCRIPTION DRUG Avar-e Green SULFACETAMIDE SODIUM, SULFUR CREAM TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0178-0465_e4e9d233-5bc8-4925-b7bb-2ac17267da90 0178-0465 HUMAN PRESCRIPTION DRUG Avar-e LS SULFACETAMIDE SODIUM, SULFUR CREAM TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM; SULFUR 100; 20 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0178-0470_e0b8ef12-db05-485a-b01b-1ccadb313399 0178-0470 HUMAN PRESCRIPTION DRUG Avar-e SULFACETAMIDE SODIUM, SULFUR CREAM TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0178-0475_51440f6c-721d-4d6b-8642-49d6511b07f1 0178-0475 HUMAN PRESCRIPTION DRUG AVAR LS SULFACETAMIDE SODIUM, SULFUR EMULSION TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM; SULFUR 100; 20 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0178-0480_23af0af2-6968-432b-9577-3a3d10f2d7f2 0178-0480 HUMAN PRESCRIPTION DRUG AVAR SULFACETAMIDE SODIUM, SULFUR EMULSION TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0178-0485_0af12201-78e9-4081-89ac-2935a457ac7c 0178-0485 HUMAN PRESCRIPTION DRUG OVACE Plus SULFACETAMIDE SODIUM SHAMPOO TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0178-0490_811287ac-0033-48ca-8038-9caa3366bb25 0178-0490 HUMAN PRESCRIPTION DRUG OVACE Plus SULFACETAMIDE SODIUM LIQUID TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0178-0495_677c0361-6cf5-4d60-8f55-c52b0bad793a 0178-0495 HUMAN PRESCRIPTION DRUG OvacePlus Plus SULFACETAMIDE SODIUM CREAM TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM 100 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0178-0499_1931b316-2687-4e44-b55a-4a9bf0c1dde9 0178-0499 HUMAN PRESCRIPTION DRUG OVACE SULFACETAMIDE SODIUM LIQUID TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0178-0500_6660b616-a82d-9109-19ce-2bdf9747acea 0178-0500 HUMAN PRESCRIPTION DRUG Lithostat acetohydroxamic acid TABLET ORAL 19830531 NDA NDA018749 Mission Pharmacal Company ACETOHYDROXAMIC ACID 250 mg/1 Urease Inhibitor [EPC],Urease Inhibitors [MoA] 0178-0513_05e900d7-3b87-4166-b213-b9e26c65ff14 0178-0513 HUMAN PRESCRIPTION DRUG Utira-C methenamine, sodium phosphate monobasic, phenyl salicylate, methylene blue, hyoscyamine sulfate TABLET ORAL 20110911 UNAPPROVED DRUG OTHER Mission Pharmacal Company HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC .12; 81.6; 10.8; 36.2; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1 0178-0582_9d525542-655c-db2b-046b-572a3017a1bf 0178-0582 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Oral Solution Prednisolone Sodium Phosphate SOLUTION ORAL 20121001 ANDA ANDA091396 Mission Pharmacal Company PREDNISOLONE SODIUM PHOSPHATE 25 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0178-0600_8729f913-309b-4f4b-896f-ba3a16821e8e 0178-0600 HUMAN PRESCRIPTION DRUG urocit-k potassium citrate TABLET, EXTENDED RELEASE ORAL 19850901 NDA NDA019071 Mission Pharmacal Company POTASSIUM CITRATE 5 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0178-0610_8729f913-309b-4f4b-896f-ba3a16821e8e 0178-0610 HUMAN PRESCRIPTION DRUG urocit-k potassium citrate TABLET, EXTENDED RELEASE ORAL 19920901 NDA NDA019071 Mission Pharmacal Company POTASSIUM CITRATE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0178-0615_8729f913-309b-4f4b-896f-ba3a16821e8e 0178-0615 HUMAN PRESCRIPTION DRUG urocit-k potassium citrate TABLET, EXTENDED RELEASE ORAL 20100127 NDA NDA019071 Mission Pharmacal Company POTASSIUM CITRATE 15 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0178-0620_f4403c67-4c49-4157-94da-9e74b83fd84f 0178-0620 HUMAN PRESCRIPTION DRUG Ovace Plus SULFACETAMIDE SODIUM LOTION TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM 98 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0178-0630_d173ed3a-224d-44f6-98b9-479b354e86a6 0178-0630 HUMAN PRESCRIPTION DRUG OVACE PLUS SODIUM SULFACETAMIDE LIQUID TOPICAL 20110907 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0178-0640_a6550370-7575-4390-ab14-305078adc78a 0178-0640 HUMAN PRESCRIPTION DRUG Avar LS Cleansing Pads SULFACETAMIDE SODIUM, SULFUR CLOTH TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM; SULFUR 100; 20 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0178-0650_d98cc6a7-5572-404e-bcd9-98f09edb306b 0178-0650 HUMAN PRESCRIPTION DRUG Avar Cleansing Pads SULFACETAMIDE SODIUM, SULFUR CLOTH TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM; SULFUR 95; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0178-0716_53d06b85-b69b-4ac6-9c55-3fa2e80fdcf2 0178-0716 HUMAN PRESCRIPTION DRUG NataFort Ascorbic acid, Cholecalciferol, .alpha.-tocopherol acetate, dl-, Thiamine mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, and Iron TABLET ORAL 20110825 UNAPPROVED DRUG OTHER Mission Pharmacal Company .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; IRON; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE 11; 120; 400; 12; 1; 60; 20; 10; 3; 2 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 0178-0796_445aeccb-7324-451e-8eac-43dc7b492245 0178-0796 HUMAN PRESCRIPTION DRUG CitraNatal Harmony 3.0 Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-Tocopherol, Dl-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent CAPSULE, GELATIN COATED ORAL 20140321 UNAPPROVED DRUG OTHER Mission Pharmacal Company .ALPHA.-TOCOPHEROL; CALCIUM CITRATE; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON; PYRIDOXINE 30; 104; 400; 260; 50; 1; 27; 25 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0178-0797_00ecf076-d840-bee7-38d1-48bae1066bff 0178-0797 HUMAN PRESCRIPTION DRUG Citranatal Harmony 2.1 Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-Tocopherol, Dl-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent CAPSULE, GELATIN COATED ORAL 20130121 UNAPPROVED DRUG OTHER NDA0123456 Mission Pharmacal Company CALCIUM CITRATE; IRON 104; 29 mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0178-0798_8b4cf96f-8706-4121-ab4f-3a469a945d97 0178-0798 HUMAN PRESCRIPTION DRUG CitraNatal Harmony Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-Tocopherol, Dl-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent CAPSULE, GELATIN COATED ORAL 20120115 UNAPPROVED DRUG OTHER MISSION PHARMACAL COMPANY .ALPHA.-TOCOPHEROL, DL-; CALCIUM CITRATE; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON PENTACARBONYL; PYRIDOXINE HYDROCHLORIDE 30; 104; 400; 260; 50; 1; 30; 25 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0178-0799_779591fd-fd24-40fe-870f-df1f1c914b22 0178-0799 HUMAN PRESCRIPTION DRUG CitraNatal Harmony Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-tocopherol, DL-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent CAPSULE, GELATIN COATED ORAL 20110418 UNAPPROVED DRUG OTHER MISSION PHARMACAL COMPANY .ALPHA.-TOCOPHEROL, DL-; CALCIUM CITRATE; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON PENTACARBONYL; PYRIDOXINE HYDROCHLORIDE 30; 100; 400; 250; 50; 1; 28; 25 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0178-0812_ffeb77e7-167b-4049-aa46-81ec06f218d1 0178-0812 HUMAN PRESCRIPTION DRUG CitraNatal Harmony Calcium citrate, Iron pentacarbonyl, Cholecalciferol, Alpha-tocopherol, DL-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent CAPSULE, GELATIN COATED ORAL 20100427 UNAPPROVED DRUG OTHER MISSION PHARMACAL COMPANY ALPHA-TOCOPHEROL, DL-; CALCIUM CITRATE; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON PENTACARBONYL; PYRIDOXINE HYDROCHLORIDE 30; 100; 400; 250; 50; 1; 27; 25 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0178-0821_81e639d7-352e-4eaa-87d9-582da68b9728 0178-0821 HUMAN PRESCRIPTION DRUG CitraNatal 90 DHA Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium TABLET ORAL 20140411 UNAPPROVED DRUG OTHER Mission Pharmacal Company .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM CITRATE; CUPRIC OXIDE; DOCUSATE SODIUM; FOLIC ACID; IRON; NIACINAMIDE; POTASSIUM TRIIODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOPRINE; THIAMINE; VITAMIN D; ZINC OXIDE 30; 120; 159; 2; 50; 1; 90; 20; 150; 20; 3.4; 3; 400; 25 [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0178-0829_62d662f4-a16f-fca3-3bd7-2a407c7bbd13 0178-0829 HUMAN OTC DRUG CitraNatal 90 DHA Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium TABLET ORAL 20100201 UNAPPROVED DRUG OTHER Mission Pharmacal Company .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM CITRATE; CUPRIC OXIDE; DOCUSATE SODIUM; FOLIC ACID; IRON; NIACINAMIDE; POTASSIUM TRIIODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOPRINE; THIAMINE; VITAMIN D; ZINC OXIDE 30; 120; 160; 2; 50; 1; 90; 20; 150; 20; 3.4; 3; 400; 25 [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 0178-0832_85ae2a1d-144d-4739-ac14-93b279b32f76 0178-0832 HUMAN PRESCRIPTION DRUG CitraNatal B-Calm Ascorbic acid, Calcium citrate, Iron, Cholecalciferol, Pyridoxine Hydrochloride, and Folic Acid KIT 20120618 UNAPPROVED DRUG OTHER Mission Pharmacal Company 0178-0858_c02cc80c-adb1-5582-6f60-d819a1e41748 0178-0858 HUMAN PRESCRIPTION DRUG CitraNatal Rx Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium TABLET ORAL 20140811 UNAPPROVED DRUG OTHER Mission Pharmacal Company .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM CITRATE; CUPRIC OXIDE; FOLIC ACID; IRON; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE; VITAMIN D; ZINC OXIDE 30; 120; 124; 2; 1; 27; 20; 150; 20; 3.4; 3; 400; 25 [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0178-0859_8ee7be74-6442-5692-edab-5d8626a510dd 0178-0859 HUMAN PRESCRIPTION DRUG CitraNatal Rx Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium TABLET ORAL 20071126 UNAPPROVED DRUG OTHER Mission Pharmacal Company .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM CITRATE; CUPRIC OXIDE; DOCUSATE SODIUM; FOLIC ACID; IRON; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE; VITAMIN D; ZINC OXIDE 30; 120; 125; 2; 50; 1; 27; 20; 150; 20; 3.4; 3; 400; 25 [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0178-0866_03d6e2ba-0ef8-48ad-ab6f-959bfbabbbf7 0178-0866 HUMAN PRESCRIPTION DRUG CitraNatal B-Calm Ascorbic Acid, Calcium Citrate, Iron Pentacarbonyl, Cholecalciferol, Pyridoxine Hydrochloride, Folic Acid KIT 20100210 UNAPPROVED DRUG OTHER Mission Pharmacal Company 0178-0891_06c529fc-272c-f889-f5e5-7f3e5ef2c59d 0178-0891 HUMAN PRESCRIPTION DRUG CitraNatal Assure ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent KIT 20140430 UNAPPROVED DRUG OTHER Mission Pharmacal Company 0178-0893_5e1b9d10-6c66-4108-9e93-c59d729cd91d 0178-0893 HUMAN PRESCRIPTION DRUG CitraNatal Assure ascorbic acid, calcium citrate, iron, vitamin d, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, DOCONE KIT 20081119 UNAPPROVED DRUG OTHER Mission Pharmacal Company 0178-0894_e5027852-b374-10e4-7acd-42f9ada83f81 0178-0894 HUMAN PRESCRIPTION DRUG CitraNatal DHA Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium KIT 20140522 UNAPPROVED DRUG OTHER Mission Pharmacal Company 0178-0898_32943e5e-f2c2-25de-6075-6ca42c87adb5 0178-0898 HUMAN OTC DRUG CitraNatal DHA Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium TABLET ORAL 20071120 UNAPPROVED DRUG OTHER Mission Pharmacal Company .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM CITRATE; CUPRIC OXIDE; DOCUSATE SODIUM; FOLIC ACID; IRON; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE; VITAMIN D; ZINC OXIDE 30; 120; 125; 2; 50; 1; 27; 20; 150; 20; 3.4; 3; 400; 25 [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 0178-0900_494a714e-923c-cd57-df6c-12886afb265a 0178-0900 HUMAN PRESCRIPTION DRUG Thiola tiopronin TABLET, SUGAR COATED ORAL 19880811 NDA NDA019569 Mission Pharmacal Company TIOPRONIN 100 mg/1 Cystine Disulfide Reduction [MoA],N-substituted Glycines [Chemical/Ingredient],Reducing and Complexing Thiol [EPC] 0178-8250_94492a08-570c-4176-a871-0977fd44d4fa 0178-8250 HUMAN PRESCRIPTION DRUG Tindamax tinidazole TABLET, FILM COATED ORAL 20040517 NDA NDA021618 Mission Pharmacal Company TINIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0178-8500_94492a08-570c-4176-a871-0977fd44d4fa 0178-8500 HUMAN PRESCRIPTION DRUG Tindamax tinidazole TABLET, FILM COATED ORAL 20040517 NDA NDA021618 Mission Pharmacal Company TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0179-0013_c5deded2-b2ea-45e3-80c2-1be15ef80b9e 0179-0013 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate sl Hyoscyamine Sulfate TABLET, ORALLY DISINTEGRATING ORAL; SUBLINGUAL 20090801 UNAPPROVED OTHER KAISER FOUNDATION HOSPITALS HYOSCYAMINE SULFATE .125 1/1 0179-0014_6b062984-4ea5-467c-8aaa-80d9aae6f622 0179-0014 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20110524 ANDA ANDA076119 KAISER FOUNDATION HOSPITALS MIRTAZAPINE 15 mg/1 0179-0015_7e711e7d-e229-48c9-b60c-9dcbdd49934f 0179-0015 HUMAN PRESCRIPTION DRUG Chlorthalidone Chlorthalidone TABLET ORAL 20090608 ANDA ANDA087180 KAISER FOUNDATION HOSPITALS CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0179-0016_0746e5d8-3971-4ad3-a558-7b13f5376f3d 0179-0016 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20090801 ANDA ANDA075347 KAISER FOUNDATION HOSPITALS OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0179-0018_a157b128-5d58-42b4-8567-cd67fc9ad5e9 0179-0018 HUMAN PRESCRIPTION DRUG LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM TABLET ORAL 20090829 ANDA ANDA090097 KAISER FOUNDATION HOSPITALS LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 0179-0019_750673fb-53e1-4c54-a610-8932cef47a0b 0179-0019 HUMAN PRESCRIPTION DRUG LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM TABLET ORAL 20090828 ANDA ANDA090097 KAISER FOUNDATION HOSPITALS LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 0179-0020_38483ace-e86e-4124-b61d-b9cad25452de 0179-0020 HUMAN PRESCRIPTION DRUG PANCRELIPASE PANCRELIPASE CAPSULE, DELAYED RELEASE ORAL 20100201 UNAPPROVED DRUG OTHER KAISER FOUNDATION HOSPITALS PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 56000; 20000; 44000 [USP'U]/1; [USP'U]/1; [USP'U]/1 0179-0021_0e6ba9cf-6c16-4af2-8ffe-90cb97b3e6a3 0179-0021 HUMAN PRESCRIPTION DRUG CLARITHROMYCIN CLARITHROMYCIN TABLET ORAL 20091001 NDA NDA050662 KAISER FOUNDATION HOSPITALS CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0179-0022_75cfa992-7b8f-4895-ae89-3432b57cafe2 0179-0022 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091001 ANDA ANDA079095 KAISER FOUNDATION HOSPITALS BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0179-0023_f1ac382c-d74a-4b01-9e16-fa9e115e9264 0179-0023 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090901 NDA NDA050162 KAISER FOUNDATION HOSPITALS CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0179-0024_f1ac382c-d74a-4b01-9e16-fa9e115e9264 0179-0024 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090901 NDA NDA050162 KAISER FOUNDATION HOSPITALS CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0179-0025_85af4b0d-ad6e-4417-9972-fbcf87c5fd34 0179-0025 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20090901 ANDA ANDA075584 KAISER FOUNDATION HOSPITALS BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0179-0026_fa6cc856-b46d-4237-9b4a-315803ad8c3b 0179-0026 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, EXTENDED RELEASE ORAL 20091028 NDA NDA020234 KAISER FOUNDATION HOSPITALS CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0179-0028_0c80436e-c57d-4cf7-afb4-a3d70e4fb5d4 0179-0028 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20100127 ANDA ANDA078957 KAISER FOUNDATION HOSPITALS STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0179-0030_75cfa992-7b8f-4895-ae89-3432b57cafe2 0179-0030 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090831 ANDA ANDA079095 KAISER FOUNDATION HOSPITALS BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0179-0033_36fb50e0-6e27-4be6-b3c9-f98dd116ad41 0179-0033 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20090901 ANDA ANDA065150 KAISER FOUNDATION HOSPITALS AZITHROMYCIN 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0179-0034_3db6ea40-7654-4370-bf87-a4ad16ff0c3e 0179-0034 HUMAN PRESCRIPTION DRUG DILANTIN PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20090920 ANDA ANDA084349 KAISER FOUNDATION HOSPITALS PHENYTOIN SODIUM 30 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0179-0036_46046ad1-f5b9-4f0a-9e77-a0f466b079f4 0179-0036 HUMAN PRESCRIPTION DRUG RE-PB HYOS ELIXIR BELLADONNA ALKALOIDS W/ PHENOBARBITAL ELIXIR ORAL 20091020 UNAPPROVED DRUG OTHER KAISER FOUNDATION HOSPITALS ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] CIV 0179-0037_435c3587-89b7-43f3-a297-6348d04c80ed 0179-0037 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, COATED ORAL 20091030 ANDA ANDA077836 KAISER FOUNDATION HOSPITALS GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0179-0039_9164a7ef-b869-4973-a552-062674d5b878 0179-0039 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene hydrochlorothiazide TABLET ORAL 20091123 ANDA ANDA072011 KAISER FOUNDATION HOSPITALS HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0179-0040_d975babc-6b9a-4101-84b2-a457140d56a4 0179-0040 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20091130 ANDA ANDA078558 KAISER FOUNDATION HOSPITALS IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0179-0043_db5fcaa7-4f01-4491-8aab-c6b8147dacee 0179-0043 HUMAN PRESCRIPTION DRUG Renvela SEVELAMER CARBONATE TABLET, FILM COATED ORAL 20100212 NDA NDA022127 KAISER FOUNDATION HOSPITALS SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 0179-0045_02ea979b-92fa-405a-b81c-4edcbefbc7bb 0179-0045 HUMAN PRESCRIPTION DRUG TEMAZEPAM temazepam CAPSULE ORAL 20100323 NDA NDA018163 KAISER FOUNDATION HOSPITALS TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0179-0048_8353922d-e8c9-4070-9747-cb84a5907b44 0179-0048 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, COATED ORAL 20100127 ANDA ANDA077836 KAISER FOUNDATION HOSPITALS GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0179-0050_e2fd95d6-8efa-427e-a22a-e7497eaa9ce0 0179-0050 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide CAPSULE, EXTENDED RELEASE ORAL 20100209 ANDA ANDA040904 KAISER FOUNDATION HOSPITALS ACETAZOLAMIDE 500 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 0179-0054_6b696dde-63cd-4c84-be57-bc1e50af323b 0179-0054 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20100226 ANDA ANDA076126 KAISER FOUNDATION HOSPITALS CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0179-0055_b4e0a4ae-4dbf-49a9-95ef-2d69b312abd0 0179-0055 HUMAN PRESCRIPTION DRUG KETOCONAZOLE KETOCONAZOLE TABLET ORAL 20100302 ANDA ANDA075597 KAISER FOUNDATION HOSPITALS KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0179-0056_c4d6eb90-2394-45b9-9c40-613d756fd43a 0179-0056 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 20100305 ANDA ANDA040761 KAISER FOUNDATION HOSPITALS HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0179-0057_097befaa-8c25-45de-a559-00299974a850 0179-0057 HUMAN PRESCRIPTION DRUG cyclobenzaprine hydrochloride cyclobenzaprine hydrochloride TABLET ORAL 20100302 ANDA ANDA077563 KAISER FOUNDATION HOSPITALS CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0179-0058_c4d6eb90-2394-45b9-9c40-613d756fd43a 0179-0058 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 20100305 ANDA ANDA040761 KAISER FOUNDATION HOSPITALS HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0179-0059_5403d9f6-00b9-4fd9-a2ce-c35333ca384f 0179-0059 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET, EXTENDED RELEASE ORAL 20100325 ANDA ANDA040723 KAISER FOUNDATION HOSPITALS ISOSORBIDE DINITRATE 40 mg/1 0179-0060_0dc31683-61c6-408c-b535-044914e900d8 0179-0060 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20100414 ANDA ANDA075245 KAISER FOUNDATION HOSPITALS FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0179-0063_e28d2e41-88d1-44a8-8efe-c95c7bb342c9 0179-0063 HUMAN PRESCRIPTION DRUG Rocaltrol calcitriol CAPSULE, GELATIN COATED ORAL 20100604 NDA NDA018044 KAISER FOUNDATION HOSPITALS CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0179-0065_bbc7e4c5-d18c-462b-a8c7-bcaabc0e0ab4 0179-0065 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100607 ANDA ANDA040907 KAISER FOUNDATION HOSPITALS HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0179-0066_47631e5f-4179-44d2-bf04-3ec5a6ab763b 0179-0066 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20100621 ANDA ANDA040627 KAISER FOUNDATION HOSPITALS BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 0179-0067_045ec573-7a0d-4da3-8534-7181bfbacf18 0179-0067 HUMAN PRESCRIPTION DRUG Ergotamine Tartrate and Caffeine Ergotamine Tartrate and Caffeine TABLET ORAL 20100625 ANDA ANDA040590 KAISER FOUNDATION HOSPITALS CAFFEINE; ERGOTAMINE TARTRATE 100; 1 mg/1; mg/1 Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0179-0068_9cd2b991-c3fa-4c04-99db-c4b64c6396cf 0179-0068 HUMAN PRESCRIPTION DRUG ANASTROZOLE ANASTROZOLE TABLET ORAL 20100713 ANDA ANDA079220 KAISER FOUNDATION HOSPITALS ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 0179-0069_e28d2e41-88d1-44a8-8efe-c95c7bb342c9 0179-0069 HUMAN PRESCRIPTION DRUG Rocaltrol calcitriol CAPSULE, GELATIN COATED ORAL 20100809 NDA NDA018044 KAISER FOUNDATION HOSPITALS CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0179-0070_96e3b125-6174-429d-8140-421afe0427f0 0179-0070 HUMAN PRESCRIPTION DRUG Pyridostigmine Bromide Pyridostigmine Bromide TABLET ORAL 20100802 ANDA ANDA040457 KAISER FOUNDATION HOSPITALS PYRIDOSTIGMINE BROMIDE 60 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0179-0071_6b062984-4ea5-467c-8aaa-80d9aae6f622 0179-0071 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20101007 ANDA ANDA076119 KAISER FOUNDATION HOSPITALS MIRTAZAPINE 30 mg/1 0179-0072_229c10c3-acef-4b91-b161-edc42adc8658 0179-0072 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20101008 ANDA ANDA088618 KAISER FOUNDATION HOSPITALS HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0179-0073_f97fdb38-50b1-46d2-bd1f-98960dabb33e 0179-0073 HUMAN PRESCRIPTION DRUG Estradiol estradiol TABLET ORAL 20101007 ANDA ANDA040326 KAISER FOUNDATION HOSPITALS ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0179-0074_f97fdb38-50b1-46d2-bd1f-98960dabb33e 0179-0074 HUMAN PRESCRIPTION DRUG Estradiol estradiol TABLET ORAL 20101020 ANDA ANDA040326 KAISER FOUNDATION HOSPITALS ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0179-0075_229c10c3-acef-4b91-b161-edc42adc8658 0179-0075 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20101008 ANDA ANDA088618 KAISER FOUNDATION HOSPITALS HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0179-0076_67c5ef8a-f7c1-4d6e-8f6c-b0c93c17d8b9 0179-0076 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20101027 ANDA ANDA065155 KAISER FOUNDATION HOSPITALS CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0179-0079_8850bb3d-e16c-4c47-9156-9c3f61bddb83 0179-0079 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20101210 ANDA ANDA065461 KAISER FOUNDATION HOSPITALS TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0179-0080_cbfd0b5a-23a7-46f6-89b6-2b1dd92e6cb9 0179-0080 HUMAN PRESCRIPTION DRUG Nuvigil ARMODAFINIL TABLET ORAL 20110128 NDA NDA021875 KAISER FOUNDATION HOSPITALS ARMODAFINIL 250 mg/1 CIV 0179-0082_cbfd0b5a-23a7-46f6-89b6-2b1dd92e6cb9 0179-0082 HUMAN PRESCRIPTION DRUG Nuvigil ARMODAFINIL TABLET ORAL 20110128 NDA NDA021875 KAISER FOUNDATION HOSPITALS ARMODAFINIL 50 mg/1 CIV 0179-0083_506833f8-eea6-4714-bf2b-dd6a159d5362 0179-0083 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20110215 ANDA ANDA078920 KAISER FOUNDATION HOSPITALS PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0179-0086_183bf87d-d8d9-4e2a-9bba-b58e42db50b5 0179-0086 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET, EXTENDED RELEASE ORAL 20110315 ANDA ANDA040723 KAISER FOUNDATION HOSPITALS ISOSORBIDE DINITRATE 40 mg/1 0179-0087_625b618a-b57c-45cc-9052-de0586e1997f 0179-0087 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 20110315 NDA NDA020564 KAISER FOUNDATION HOSPITALS LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0179-0088_853b6858-1f2f-4f17-82a4-9af4cd5a18a7 0179-0088 HUMAN PRESCRIPTION DRUG DONNATAL BELLADONNA ALKALOIDS W/ PHENOBARBITAL ELIXIR ORAL 20110330 UNAPPROVED DRUG OTHER KAISER FOUNDATION HOSPITALS ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] CIV 0179-0089_eb4f1418-2342-4174-a448-1335dea53deb 0179-0089 HUMAN PRESCRIPTION DRUG CAFERGOT Ergotamine Tartrate and Caffeine TABLET ORAL 20110421 ANDA ANDA084294 KAISER FOUNDATION HOSPITALS CAFFEINE; ERGOTAMINE TARTRATE 100; 1 mg/1; mg/1 Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0179-0090_f481691b-d760-420e-a1df-e1c6ff084cb4 0179-0090 HUMAN PRESCRIPTION DRUG DARAPRIM pyrimethamine TABLET ORAL 20110420 NDA NDA008578 KAISER FOUNDATION HOSPITALS PYRIMETHAMINE 25 mg/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 0179-0091_91ac7b9e-7290-4397-a097-7e1f487bb463 0179-0091 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20110426 ANDA ANDA076509 KAISER FOUNDATION HOSPITALS FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0179-0092_1b3fb004-351e-4301-83e3-420619f7ec48 0179-0092 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20110606 ANDA ANDA090200 KAISER FOUNDATION HOSPITALS METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0179-0093_ca0b258f-54fb-4f66-ae18-83d45c1702f9 0179-0093 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20110608 ANDA ANDA074342 KAISER FOUNDATION HOSPITALS ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0179-0094_ca0b258f-54fb-4f66-ae18-83d45c1702f9 0179-0094 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20110608 ANDA ANDA074342 KAISER FOUNDATION HOSPITALS ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0179-0095_1b3fb004-351e-4301-83e3-420619f7ec48 0179-0095 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20110607 ANDA ANDA090200 KAISER FOUNDATION HOSPITALS METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0179-0096_65d41ac2-fa4e-4881-9cbe-9e96b3894638 0179-0096 HUMAN PRESCRIPTION DRUG RESCRIPTOR delavirdine mesylate TABLET ORAL 20110706 NDA NDA020705 KAISER FOUNDATION HOSPITALS DELAVIRDINE MESYLATE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] 0179-0098_76c4d6e1-a61f-400e-8293-300773a7faff 0179-0098 HUMAN PRESCRIPTION DRUG ELIPHOS Calcium Acetate TABLET ORAL 20110824 ANDA ANDA078502 KAISER FOUNDATION HOSPITALS CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0179-0099_5fbfa44c-a26e-47aa-82a1-b496375622f5 0179-0099 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET ORAL 20110912 ANDA ANDA077851 KAISER FOUNDATION HOSPITALS ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0179-0100_5fbfa44c-a26e-47aa-82a1-b496375622f5 0179-0100 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET ORAL 20110912 ANDA ANDA077851 KAISER FOUNDATION HOSPITALS ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0179-0101_38e8ad75-0f1b-49dd-bf4e-6a6d51a8b476 0179-0101 HUMAN PRESCRIPTION DRUG ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE ORAL 20111031 ANDA ANDA040009 KAISER FOUNDATION HOSPITALS ISOSORBIDE DINITRATE 40 mg/1 0179-0102_cb3bc5aa-99ed-4705-951a-a2220ef78016 0179-0102 HUMAN PRESCRIPTION DRUG LEVITRA VARDENAFIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20111028 NDA NDA021400 KAISER FOUNDATION HOSPITALS VARDENAFIL HYDROCHLORIDE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0179-0103_91ac7b9e-7290-4397-a097-7e1f487bb463 0179-0103 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20110803 ANDA ANDA076509 KAISER FOUNDATION HOSPITALS FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0179-0104_7b839750-2c0c-41f2-a0d3-09f5a9902ba9 0179-0104 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120106 NDA AUTHORIZED GENERIC NDA019839 KAISER FOUNDATION HOSPITALS SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0179-0105_2118df83-73ab-4150-babc-8b48aacd80af 0179-0105 HUMAN PRESCRIPTION DRUG Erythrocin Stearate ERYTHROMYCIN STEARATE TABLET, FILM COATED ORAL 20120106 ANDA ANDA060359 KAISER FOUNDATION HOSPITALS ERYTHROMYCIN STEARATE 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0179-0107_dcbbc15f-bfe1-43aa-9559-572c4e88a729 0179-0107 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET ORAL 20120105 ANDA ANDA078301 KAISER FOUNDATION HOSPITALS VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0179-0108_dcbbc15f-bfe1-43aa-9559-572c4e88a729 0179-0108 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET ORAL 20120105 ANDA ANDA078301 KAISER FOUNDATION HOSPITALS VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0179-0109_dcbbc15f-bfe1-43aa-9559-572c4e88a729 0179-0109 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET ORAL 20120105 ANDA ANDA078301 KAISER FOUNDATION HOSPITALS VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0179-0110_508792d2-f09b-4cab-9bd7-b58734b649f9 0179-0110 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 20120213 ANDA ANDA074185 KAISER FOUNDATION HOSPITALS DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0179-0111_5efdc7de-6f5f-4922-990d-8aa55938d4f1 0179-0111 HUMAN PRESCRIPTION DRUG ASACOL mesalamine TABLET, DELAYED RELEASE ORAL 20120223 NDA NDA019651 KAISER FOUNDATION HOSPITALS MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 0179-0112_1a082d12-9299-43da-9023-d3d5c97bdcd0 0179-0112 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20120406 ANDA ANDA040409 KAISER FOUNDATION HOSPITALS ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0179-0113_efdf7a98-8df8-4ad1-9c84-8ed8961242be 0179-0113 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20120406 ANDA ANDA040655 KAISER FOUNDATION HOSPITALS ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0179-0115_bc719866-7046-47e0-9506-1d0b79cdc582 0179-0115 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20120509 ANDA ANDA075682 KAISER FOUNDATION HOSPITALS IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0179-0116_efdf7a98-8df8-4ad1-9c84-8ed8961242be 0179-0116 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20120426 ANDA ANDA040355 KAISER FOUNDATION HOSPITALS ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0179-0117_a85e64fd-e5e2-4382-a3f1-8c5ae18c2314 0179-0117 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN Erythromycin CAPSULE, DELAYED RELEASE ORAL 20120426 ANDA ANDA062746 KAISER FOUNDATION HOSPITALS ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0179-0118_aca972ce-fb7a-45eb-82a3-f970669bb658 0179-0118 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 20120531 ANDA ANDA088292 KAISER FOUNDATION HOSPITALS IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0179-0119_bc719866-7046-47e0-9506-1d0b79cdc582 0179-0119 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20120605 ANDA ANDA075682 KAISER FOUNDATION HOSPITALS IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0179-0120_18864075-2cd2-4c15-97e2-a50be9963bc5 0179-0120 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20120531 ANDA ANDA074430 KAISER FOUNDATION HOSPITALS DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0179-0122_06763473-e347-4170-8d55-da76c813795e 0179-0122 HUMAN PRESCRIPTION DRUG Methylergonovine Maleate Methylergonovine Maleate TABLET ORAL 20120531 ANDA ANDA091577 KAISER FOUNDATION HOSPITALS METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 0179-0123_906c42de-5239-4b1e-bef8-479a7e652283 0179-0123 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20120912 ANDA ANDA040197 KAISER FOUNDATION HOSPITALS ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0179-0124_2b664604-2426-4739-ad47-c487c569a2fe 0179-0124 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 20120912 ANDA ANDA040189 KAISER FOUNDATION HOSPITALS METHYLPREDNISOLONE 16 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0179-0125_8db227a4-f232-4c2c-af4c-65afcac2f396 0179-0125 HUMAN PRESCRIPTION DRUG LODOSYN CARBIDOPA TABLET ORAL 20120925 NDA NDA017830 KAISER FOUNDATION HOSPITALS CARBIDOPA 25 mg/1 0179-0126_312d8e1a-cce2-4410-9473-1638d78df5fb 0179-0126 HUMAN PRESCRIPTION DRUG EDECRIN ethacrynic acid TABLET ORAL 20130110 NDA NDA016092 KAISER FOUNDATION HOSPITALS ETHACRYNIC ACID 25 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0179-0127_8ad17089-6918-418d-91ee-6cee09494c11 0179-0127 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20130115 ANDA ANDA071851 KAISER FOUNDATION HOSPITALS HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0179-0128_13b2a26c-df43-4eb1-9983-84de90cccd55 0179-0128 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130201 ANDA ANDA076052 KAISER FOUNDATION HOSPITALS SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0179-0129_5ed9d185-f5dd-4d83-bd04-4492dc8df0f1 0179-0129 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20130314 ANDA ANDA065285 KAISER FOUNDATION HOSPITALS DOXYCYCLINE 100 mg/1 0179-0131_0dc4bedf-b51f-487e-b2f2-a8f5f950cf41 0179-0131 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20130311 ANDA ANDA071403 KAISER FOUNDATION HOSPITALS LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0179-0132_0994a046-29f9-48c3-842a-8ac7f49dfcb3 0179-0132 HUMAN PRESCRIPTION DRUG Donnatal Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide TABLET ORAL 20130702 UNAPPROVED DRUG OTHER KAISER FOUNDATION HOSPITALS ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] CIV 0179-0133_4486fcc5-d3d8-40d9-bf0a-2f8965dd54fc 0179-0133 HUMAN PRESCRIPTION DRUG Mephyton phytonadione TABLET ORAL 20130729 NDA NDA010104 KAISER FOUNDATION HOSPITALS PHYTONADIONE 5 mg/1 Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 0179-0135_10055ce4-847f-456b-949b-b8697a318d9f 0179-0135 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130805 ANDA ANDA077321 KAISER FOUNDATION HOSPITALS LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0179-0137_3d4b2003-5ac2-4d6f-b699-e984faad9cff 0179-0137 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20130819 ANDA ANDA040511 KAISER FOUNDATION HOSPITALS ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 0179-0138_f98753ea-78a4-412f-99af-eb9e18720527 0179-0138 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20130924 ANDA ANDA076899 KAISER FOUNDATION HOSPITALS SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0179-0140_bd18900c-acae-4ac3-86b0-b07f7fe19ec8 0179-0140 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline TABLET ORAL 20140428 ANDA ANDA065070 KAISER FOUNDATION HOSPITALS DOXYCYCLINE 100 mg/1 0179-0141_d332f56a-2571-49b1-abab-68b95e678bd5 0179-0141 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20131105 NDA AUTHORIZED GENERIC NDA020702 KAISER FOUNDATION HOSPITALS ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0179-0142_5d64a942-c06b-4182-9b7d-eb29e910d4a7 0179-0142 HUMAN PRESCRIPTION DRUG Lialda mesalamine TABLET, DELAYED RELEASE ORAL 20131206 NDA NDA022000 KAISER FOUNDATION HOSPITALS MESALAMINE 1.2 g/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 0179-0143_48c67779-1716-4aa6-bcde-1e5803f74503 0179-0143 HUMAN PRESCRIPTION DRUG Rilutek riluzole TABLET ORAL 20140120 NDA NDA020599 KAISER FOUNDATION HOSPITALS RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] 0179-0144_b5ae5515-870d-4baf-8f24-e71d83ee91e1 0179-0144 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140120 ANDA ANDA090778 KAISER FOUNDATION HOSPITALS DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0179-0146_5faf7ef7-7894-4739-a34f-f02aaa6ba325 0179-0146 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140311 ANDA ANDA063083 KAISER FOUNDATION HOSPITALS CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0179-0147_5faf7ef7-7894-4739-a34f-f02aaa6ba325 0179-0147 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140311 ANDA ANDA063083 KAISER FOUNDATION HOSPITALS CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0179-0148_ae73fe84-3592-4606-a09d-e624cff2d23e 0179-0148 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140428 ANDA ANDA071403 KAISER FOUNDATION HOSPITALS LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0179-0149_54ec910c-7486-4de2-ab26-b5d185939197 0179-0149 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20140514 ANDA ANDA091649 KAISER FOUNDATION HOSPITALS CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0179-0150_a361dab4-4407-4297-83e9-45e1ab7d3df1 0179-0150 HUMAN PRESCRIPTION DRUG Riluzole Riluzole TABLET, FILM COATED ORAL 20140514 ANDA ANDA091417 KAISER FOUNDATION HOSPITALS RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] 0179-0151_e31d1911-11a1-4342-b05f-dd3da73ca3fb 0179-0151 HUMAN PRESCRIPTION DRUG Raloxifene hydrochloride Raloxifene hydrochloride TABLET ORAL 20140529 NDA AUTHORIZED GENERIC NDA020815 KAISER FOUNDATION HOSPITALS RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 0179-0152_2240bccc-9851-42bc-ba78-f8cf8f2ae82c 0179-0152 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20140529 ANDA ANDA202941 KAISER FOUNDATION HOSPITALS LAMIVUDINE 100 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0179-0153_6de478f3-9c92-4097-9948-232df518468c 0179-0153 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride TABLET, FILM COATED ORAL 20140529 ANDA ANDA077220 KAISER FOUNDATION HOSPITALS PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 0179-0154_abffd938-0045-4af6-9a78-bb2f730beff1 0179-0154 HUMAN PRESCRIPTION DRUG Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate TABLET ORAL 20140707 UNAPPROVED DRUG OTHER KAISER FOUNDATION HOSPITALS POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 155; 852; 130 mg/1; mg/1; mg/1 0179-0155_4a695bb4-09c6-472d-96db-f38564263242 0179-0155 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20140903 NDA AUTHORIZED GENERIC NDA008697 KAISER FOUNDATION HOSPITALS HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0179-0157_81e118df-add9-4dde-8cfa-e6a7ef58cd69 0179-0157 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20140903 ANDA ANDA078554 KAISER FOUNDATION HOSPITALS VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0179-0158_81e118df-add9-4dde-8cfa-e6a7ef58cd69 0179-0158 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20140903 ANDA ANDA078554 KAISER FOUNDATION HOSPITALS VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0179-0159_81e118df-add9-4dde-8cfa-e6a7ef58cd69 0179-0159 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20140903 ANDA ANDA078554 KAISER FOUNDATION HOSPITALS VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0179-0160_d578896f-5f36-4bac-8ee0-24cf67141252 0179-0160 HUMAN PRESCRIPTION DRUG Sildenafil sildenafil citrate TABLET, FILM COATED ORAL 20140919 NDA AUTHORIZED GENERIC NDA021845 KAISER FOUNDATION HOSPITALS SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0179-0161_1222336d-95b9-499c-bd78-04fd470597b9 0179-0161 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141027 ANDA ANDA200834 KAISER FOUNDATION HOSPITALS VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0179-0162_1222336d-95b9-499c-bd78-04fd470597b9 0179-0162 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141027 ANDA ANDA200834 KAISER FOUNDATION HOSPITALS VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0179-0163_d25bf40a-dd3c-45d2-bfb0-7541ee7b324c 0179-0163 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20141107 ANDA ANDA071404 KAISER FOUNDATION HOSPITALS LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0179-0164_34410165-09ca-46bb-82d0-433b0fdf6e89 0179-0164 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20141111 ANDA ANDA074569 KAISER FOUNDATION HOSPITALS CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0179-0165_c803f04c-c4e0-4120-88e8-86a721323987 0179-0165 HUMAN PRESCRIPTION DRUG Bromocriptine Mesylate bromocriptine mesylate TABLET ORAL 20141010 ANDA ANDA076962 KAISER FOUNDATION HOSPITALS BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 0179-0166_86d22c23-5caf-4297-8658-1a6c223abe87 0179-0166 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20141010 NDA AUTHORIZED GENERIC NDA020796 KAISER FOUNDATION HOSPITALS ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0179-0167_7e2004b6-e4f7-48bf-b60a-bfb267bfdf89 0179-0167 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20141111 ANDA ANDA063083 KAISER FOUNDATION HOSPITALS CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0179-0276_32a7a6d3-83fc-48fd-980b-fcffcf5307e1 0179-0276 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 KAISER FOUNDATION HOSPITALS ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 0179-1026_efdf7a98-8df8-4ad1-9c84-8ed8961242be 0179-1026 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20110331 ANDA ANDA089971 KAISER FOUNDATION HOSPITALS ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0179-1118_704c68fb-5c1d-4ead-bbe1-65d72a2aae9c 0179-1118 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19871222 ANDA ANDA071523 KAISER FOUNDATION HOSPITALS TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 0179-1427_cba68fb7-f59b-41ba-91f5-45f29d1713f1 0179-1427 HUMAN PRESCRIPTION DRUG ERY-TAB ERYTHROMYCIN TABLET, DELAYED RELEASE ORAL 20090828 ANDA ANDA062298 KAISER FOUNDATION HOSPITALS ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0179-1429_01bf0c1a-33f1-4ce4-949c-a9794a2843ef 0179-1429 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20020129 ANDA ANDA071321 KAISER FOUNDATION HOSPITALS DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0179-1431_01bf0c1a-33f1-4ce4-949c-a9794a2843ef 0179-1431 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20020129 ANDA ANDA071322 KAISER FOUNDATION HOSPITALS DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0179-1433_35f632b4-e364-4feb-9ae6-f6e39f0b2c5b 0179-1433 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20110718 ANDA ANDA075636 KAISER FOUNDATION HOSPITALS LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0179-1434_35f632b4-e364-4feb-9ae6-f6e39f0b2c5b 0179-1434 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20110718 ANDA ANDA075636 KAISER FOUNDATION HOSPITALS LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0179-1435_35f632b4-e364-4feb-9ae6-f6e39f0b2c5b 0179-1435 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20110718 ANDA ANDA075636 KAISER FOUNDATION HOSPITALS LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0179-1445_4bafe79e-f2df-4cb8-8508-7e55d21e7ba8 0179-1445 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20140617 ANDA ANDA073553 KAISER FOUNDATION HOSPITALS NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0179-1470_931c59f1-1bf9-4b4a-8577-3a56fa59bd1c 0179-1470 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20030602 ANDA ANDA071638 KAISER FOUNDATION HOSPITALS TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0179-1471_bae2a6dd-5863-4b8e-886e-8b95af461a97 0179-1471 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20050216 ANDA ANDA075511 KAISER FOUNDATION HOSPITALS FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0179-1482_f7ccb1b4-d47a-43f3-9ae9-aef5348f7917 0179-1482 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20031231 ANDA ANDA070033 KAISER FOUNDATION HOSPITALS METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0179-1804_455410ed-69b7-45c1-9400-92318ab5560d 0179-1804 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20060602 ANDA ANDA075410 KAISER FOUNDATION HOSPITALS OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0179-1838_e0f78c42-fdc4-4462-a444-3a5c1a01e5a2 0179-1838 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20060804 ANDA ANDA065062 KAISER FOUNDATION HOSPITALS MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0179-1952_089a379c-072b-49a6-af3f-15ff33b3188c 0179-1952 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20080324 ANDA ANDA075797 KAISER FOUNDATION HOSPITALS TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 0179-1957_1a082d12-9299-43da-9023-d3d5c97bdcd0 0179-1957 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20080319 ANDA ANDA040400 KAISER FOUNDATION HOSPITALS ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0179-1964_713b8b32-8f7c-49cb-9f7f-ff3b754bfaba 0179-1964 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080714 ANDA ANDA074112 KAISER FOUNDATION HOSPITALS ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0179-1965_713b8b32-8f7c-49cb-9f7f-ff3b754bfaba 0179-1965 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080714 ANDA ANDA074112 KAISER FOUNDATION HOSPITALS ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0179-1969_6ded2df8-302e-43ee-bc74-bfcd54783fdf 0179-1969 HUMAN PRESCRIPTION DRUG amlodipine besylate AMLODIPINE BESYLATE TABLET ORAL 20081021 NDA AUTHORIZED GENERIC NDA019787 KAISER FOUNDATION HOSPITALS AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0179-1970_6ded2df8-302e-43ee-bc74-bfcd54783fdf 0179-1970 HUMAN PRESCRIPTION DRUG amlodipine besylate AMLODIPINE BESYLATE TABLET ORAL 20081021 NDA AUTHORIZED GENERIC NDA019787 KAISER FOUNDATION HOSPITALS AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0179-1971_c8056e90-b589-4d6f-82e3-44362afb1a48 0179-1971 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20080802 ANDA ANDA040489 KAISER FOUNDATION HOSPITALS METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0179-1973_6ded2df8-302e-43ee-bc74-bfcd54783fdf 0179-1973 HUMAN PRESCRIPTION DRUG amlodipine besylate AMLODIPINE BESYLATE TABLET ORAL 20081021 NDA AUTHORIZED GENERIC NDA019787 KAISER FOUNDATION HOSPITALS AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0179-1978_e06da151-5168-405d-94e7-2d89737530fc 0179-1978 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20081020 ANDA ANDA078250 KAISER FOUNDATION HOSPITALS NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0179-1980_d17524df-0382-480d-9892-0582c6ee93ab 0179-1980 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, COATED ORAL 20081001 NDA NDA077322 KAISER FOUNDATION HOSPITALS ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0179-1981_d17524df-0382-480d-9892-0582c6ee93ab 0179-1981 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, COATED ORAL 20081001 NDA NDA077322 KAISER FOUNDATION HOSPITALS ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0179-1982_34b7fb5d-113e-4fee-baa5-7b19c3f662e1 0179-1982 HUMAN PRESCRIPTION DRUG Ciprofloxacin hydrochloride Ciprofloxacin hydrochloride TABLET ORAL 20110623 ANDA ANDA076089 KAISER FOUNDATION HOSPITALS CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0179-1984_10055ce4-847f-456b-949b-b8697a318d9f 0179-1984 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20081103 ANDA ANDA077321 KAISER FOUNDATION HOSPITALS LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0179-1985_10055ce4-847f-456b-949b-b8697a318d9f 0179-1985 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20081103 ANDA ANDA077321 KAISER FOUNDATION HOSPITALS LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0179-1988_10055ce4-847f-456b-949b-b8697a318d9f 0179-1988 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20081103 ANDA ANDA077321 KAISER FOUNDATION HOSPITALS LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0179-8012_f31aa13f-2536-4815-b365-899cff4d78a0 0179-8012 HUMAN OTC DRUG KAISER PERMANENTE Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Kaiser Foundation Hospitals BACITRACIN ZINC 500 [iU]/g 0179-8014_8e606bce-9248-4f9e-bfdf-e187b2a5053f 0179-8014 HUMAN OTC DRUG Clotrimazole Athletes Foot Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Kaiser Foundation Hospitals CLOTRIMAZOLE 10 mg/g 0179-8016_80d79abf-cabf-4cd6-9005-a4f272a4f42c 0179-8016 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20010913 OTC MONOGRAPH NOT FINAL part348 Kaiser Foundation Hospitals HYDROCORTISONE .5 g/100g 0179-8017_9d126a09-ab43-43b0-beaa-face4202b702 0179-8017 HUMAN OTC DRUG Kaiser Permanente Miconazole Nitrate Miconazole Nitrate CREAM TOPICAL 19911001 OTC MONOGRAPH FINAL part333C Kaiser Foundation Hospitals MICONAZOLE NITRATE 20 mg/g 0179-8019_de5605f4-f404-45df-906f-29484ce60bed 0179-8019 HUMAN OTC DRUG Kaiser Permanente Tolnaftate Tolnaftate CREAM TOPICAL 20060217 OTC MONOGRAPH FINAL part333C Kaiser Foundations Hospitals TOLNAFTATE 10 mg/g 0179-8104_22c9d184-588a-b631-cdd1-855321c359a4 0179-8104 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20110521 ANDA ANDA078878 Kaiser Permanente OMEPRAZOLE MAGNESIUM 20 mg/1 0179-8301_0f725624-ce3b-493c-9045-40162d7f4e11 0179-8301 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20131213 ANDA ANDA077829 Kaiser Foundation Hospitals CETIRIZINE HYDROCHLORIDE 10 mg/1 0179-8302_2e88539e-c12a-4e2d-b945-2942dfb0f07c 0179-8302 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20131213 ANDA ANDA077829 Kaiser Foundation Hospitals CETIRIZINE HYDROCHLORIDE 5 mg/1 0179-8317_ba205a3b-7606-4696-b613-52c6b5659d16 0179-8317 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20110223 ANDA ANDA076134 Kaiser Foundation Hospitals LORATADINE 10 mg/1 0179-8325_0c653c18-d0c4-ce0c-1ff9-33c5ac239458 0179-8325 HUMAN OTC DRUG Fexofenadine Hydrochloride 180 Fexofenadine Hydrochloride TABLET ORAL 20120705 ANDA ANDA076502 Kaiser Permanente FEXOFENADINE HYDROCHLORIDE 180 mg/1 0179-8702_1f8452ab-d273-4e0d-9f8b-596c544cd9e2 0179-8702 HUMAN OTC DRUG kaiser permanente benzoyl peroxide BENZOYL PEROXIDE GEL TOPICAL 20070608 OTC MONOGRAPH FINAL part333D Kaiser Foundation Hospitals BENZOYL PEROXIDE 5 g/100g 0179-8703_50a228c7-27a8-4d7a-bc93-a562b44a0509 0179-8703 HUMAN OTC DRUG kaiser permanente benzoyl peroxide BENZOYL PEROXIDE GEL TOPICAL 20070608 OTC MONOGRAPH FINAL part333D Kaiser Foundation Hospitals BENZOYL PEROXIDE 10 g/100g 0179-8704_5f7cfd89-5415-4fb6-86c9-fa98c130cd20 0179-8704 HUMAN OTC DRUG kaiser permanente benzoyl peroxide BENZOYL PEROXIDE LIQUID TOPICAL 20070608 OTC MONOGRAPH FINAL part333D Kaiser Foundation Hospitals BENZOYL PEROXIDE 10 g/100g 0179-8705_216e139a-d81a-4727-8365-364765acd675 0179-8705 HUMAN OTC DRUG kaiser permanente benzoyl peroxide BENZOYL PEROXIDE LIQUID TOPICAL 20070608 OTC MONOGRAPH FINAL part333D Kaiser Foundation Hospitals BENZOYL PEROXIDE 5 g/100g 0179-8707_567aaa53-2b89-40cc-b881-e653ca2b8bb2 0179-8707 HUMAN OTC DRUG Kaiser Permanente Double antibiotic Bacitracin zinc and Polymyxin B sulfate OINTMENT TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Kaiser Foundations Hospitals BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g 0179-8710_4ba36b39-12c4-4f96-a8ca-761d70d90ee6 0179-8710 HUMAN OTC DRUG KAISER PERMANENTE Hydrocortisone Hydrocortisone acetate CREAM TOPICAL 20010601 OTC MONOGRAPH NOT FINAL part348 Kaiser Foundation Hospitals HYDROCORTISONE ACETATE 1 g/100g 0179-8711_4986e78a-ac51-461b-a8ea-d49bc4b26331 0179-8711 HUMAN OTC DRUG KAISER PERMANENTE Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Kaiser Foundation Hospitals HYDROCORTISONE 1 g/100g 0179-8715_657d8ac9-5eec-433a-ab09-04e279800d29 0179-8715 HUMAN OTC DRUG KAISER PERMANENTE Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Kaiser Foundation Hospitals TERBINAFINE HYDROCHLORIDE 1 g/100g 0182-1093_182c80dd-f19b-462c-9b9a-ff2d03de17c8 0182-1093 HUMAN OTC DRUG SennaGen Sennosides TABLET, COATED ORAL 20000101 20161231 OTC MONOGRAPH NOT FINAL part334 Goldline Laboratories, Inc. SENNOSIDES A AND B 8.6 mg/1 0182-1093_afc806cd-64d0-49ac-9888-3a2ee54890e2 0182-1093 HUMAN OTC DRUG SENNAGEN Sennosides TABLET, COATED ORAL 20000101 20161231 OTC MONOGRAPH NOT FINAL part334 Goldline Laboratories, Inc. SENNOSIDES A AND B 8.6 mg/1 0182-1113_1568ffd1-b677-43d8-9076-3e3d89c40f46 0182-1113 HUMAN OTC DRUG Senna-S Docusate sodium and Sennosides TABLET, FILM COATED ORAL 19990323 20161031 OTC MONOGRAPH NOT FINAL part334 Goldline Laboratories, Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 0182-1113_a44b5cbd-ea0d-4bd0-8988-d6e5f9fb9a86 0182-1113 HUMAN OTC DRUG Senna-S Docusate sodium and Sennosides TABLET, FILM COATED ORAL 19990323 20161130 OTC MONOGRAPH NOT FINAL part334 Goldline Laboratories, Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 0185-0010_5935b0eb-4384-4bd6-a652-74f8f0c3ab31 0185-0010 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 19980804 ANDA ANDA075113 Eon Labs, Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0185-0017_fce8ec0f-605f-454c-91bd-534f08461eba 0185-0017 HUMAN PRESCRIPTION DRUG fluvoxamine maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20001129 ANDA ANDA075888 Eon Labs, Inc. FLUVOXAMINE MALEATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0185-0020_ebec0e13-3c1e-457b-b95d-02fdafcd173b 0185-0020 HUMAN PRESCRIPTION DRUG mirtazapine mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076219 Eon Labs, Inc. MIRTAZAPINE 15 mg/1 0185-0022_8120fe4d-7799-4de6-bf2f-f8c8721d11ae 0185-0022 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET ORAL 20000215 ANDA ANDA040327 Eon Labs, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0185-0025_57da7501-d1bd-4304-9508-79af23bfd52c 0185-0025 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Eon Labs, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0185-0027_fce8ec0f-605f-454c-91bd-534f08461eba 0185-0027 HUMAN PRESCRIPTION DRUG fluvoxamine maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20001129 ANDA ANDA075888 Eon Labs, Inc. FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0185-0032_0bce1b04-eb86-4f57-a179-bd214732a5d4 0185-0032 HUMAN PRESCRIPTION DRUG Reserpine Reserpine TABLET ORAL 19880311 NDA NDA009838 Eon Labs, Inc. RESERPINE .1 mg/1 Catecholamine-depleting Sympatholytic [EPC],Decreased Sympathetic Activity [PE] 0185-0034_bb87771f-5105-4c5e-825c-0221523fb7c6 0185-0034 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride TABLET ORAL 20021126 ANDA ANDA076280 Eon Labs, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0185-0039_3b36d91d-e979-42ed-9c69-736dd1fbb24a 0185-0039 HUMAN PRESCRIPTION DRUG naltrexone hydrochloride naltrexone hydrochloride TABLET, FILM COATED ORAL 20000308 ANDA ANDA075434 Eon Labs, Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] 0185-0040_d9dd022c-e8cf-4b31-948b-8f8beb556dcb 0185-0040 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20030911 ANDA ANDA076514 Eon Labs, Inc. MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0185-0041_100a257a-261b-411e-8197-dac277df9d53 0185-0041 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040423 ANDA ANDA076483 Eon Labs, Inc. FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0185-0042_100a257a-261b-411e-8197-dac277df9d53 0185-0042 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040423 ANDA ANDA076483 Eon Labs, Inc. FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0185-0043_d9dd022c-e8cf-4b31-948b-8f8beb556dcb 0185-0043 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20030911 ANDA ANDA076514 Eon Labs, Inc. MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0185-0047_100a257a-261b-411e-8197-dac277df9d53 0185-0047 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040423 ANDA ANDA076483 Eon Labs, Inc. FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0185-0048_937be6ce-4d33-4eb0-80e9-6ec7467c3c34 0185-0048 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076402 Eon Labs, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0185-0053_937be6ce-4d33-4eb0-80e9-6ec7467c3c34 0185-0053 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076402 Eon Labs, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0185-0055_a75a7b62-e163-4a4f-adc2-2db73f429239 0185-0055 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20031219 ANDA ANDA076466 Eon Labs, Inc. METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0185-0063_06de89c4-943b-4eaa-881d-a24a101ba245 0185-0063 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970829 ANDA ANDA074979 Eon Labs, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0185-0064_06de89c4-943b-4eaa-881d-a24a101ba245 0185-0064 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970829 ANDA ANDA074979 Eon Labs, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0185-0065_06de89c4-943b-4eaa-881d-a24a101ba245 0185-0065 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970829 ANDA ANDA074979 Eon Labs, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0185-0070_04607cd0-69d3-4ac3-933e-1b624a083ac0 0185-0070 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075636 Eon Labs, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0185-0072_04607cd0-69d3-4ac3-933e-1b624a083ac0 0185-0072 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075636 Eon Labs, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0185-0074_04607cd0-69d3-4ac3-933e-1b624a083ac0 0185-0074 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075636 Eon Labs, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0185-0084_6b7d6ab8-b9ee-40db-a0b0-715194f69d32 0185-0084 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020927 ANDA ANDA040439 Eon Labs, Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0185-0101_57da7501-d1bd-4304-9508-79af23bfd52c 0185-0101 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Eon Labs, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0185-0102_57da7501-d1bd-4304-9508-79af23bfd52c 0185-0102 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Eon Labs, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0185-0103_57da7501-d1bd-4304-9508-79af23bfd52c 0185-0103 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Eon Labs, Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0185-0104_57da7501-d1bd-4304-9508-79af23bfd52c 0185-0104 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Eon Labs, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0185-0111_6b7d6ab8-b9ee-40db-a0b0-715194f69d32 0185-0111 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020614 ANDA ANDA040439 Eon Labs, Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0185-0115_69bb6c03-a786-4ced-9d02-ee541657f376 0185-0115 HUMAN PRESCRIPTION DRUG Ticlopidine Hydrochloride Ticlopidine Hydrochloride TABLET, FILM COATED ORAL 19990820 ANDA ANDA075326 Eon Labs, Inc. TICLOPIDINE HYDROCHLORIDE 250 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0185-0117_5935b0eb-4384-4bd6-a652-74f8f0c3ab31 0185-0117 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 19980804 ANDA ANDA075113 Eon Labs, Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0185-0118_5935b0eb-4384-4bd6-a652-74f8f0c3ab31 0185-0118 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 19980804 ANDA ANDA075113 Eon Labs, Inc. LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0185-0122_7518452b-032f-409c-beed-5b1d1610f379 0185-0122 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin (monohydrate/macrocrystals) CAPSULE ORAL 20050406 ANDA ANDA077066 Eon Labs, Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 0185-0123_e5221d69-4897-4884-a283-726b8485f1e7 0185-0123 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20051108 ANDA ANDA077310 Eon Labs, Inc. CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0185-0124_7c44f0c9-46b4-4ad6-aa20-1b451da9651a 0185-0124 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076631 Eon Labs, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0185-0128_4b10a074-daac-4448-9dbe-b65c549e5c59 0185-0128 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 19961121 ANDA ANDA074700 Eon Labs, Inc. BUMETANIDE .5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0185-0129_4b10a074-daac-4448-9dbe-b65c549e5c59 0185-0129 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 19961121 ANDA ANDA074700 Eon Labs, Inc. BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0185-0130_4b10a074-daac-4448-9dbe-b65c549e5c59 0185-0130 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 19961121 ANDA ANDA074700 Eon Labs, Inc. BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0185-0134_0bce1b04-eb86-4f57-a179-bd214732a5d4 0185-0134 HUMAN PRESCRIPTION DRUG Reserpine Reserpine TABLET ORAL 19880311 NDA NDA009838 Eon Labs, Inc. RESERPINE .25 mg/1 Catecholamine-depleting Sympatholytic [EPC],Decreased Sympathetic Activity [PE] 0185-0139_e0589a18-35ae-4438-9571-7fae8f93faa4 0185-0139 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, COATED ORAL 19990419 ANDA ANDA074903 Eon Labs, Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0185-0140_e0589a18-35ae-4438-9571-7fae8f93faa4 0185-0140 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, COATED ORAL 19970411 ANDA ANDA074903 Eon Labs, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0185-0141_9cc9adbe-0a51-41a6-8b42-a8b66f587c77 0185-0141 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET ORAL 20010131 ANDA ANDA075845 Eon Labs, Inc. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0185-0144_6ba8cf32-fab8-4bac-80ff-936ab23fd747 0185-0144 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 19981223 ANDA ANDA075315 Eon Labs, Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0185-0145_8d481ce1-e155-48d0-a6d3-5a647550b070 0185-0145 HUMAN PRESCRIPTION DRUG Nabumetone Nabumentone TABLET ORAL 20020225 ANDA ANDA075280 Eon Labs, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0185-0146_8d481ce1-e155-48d0-a6d3-5a647550b070 0185-0146 HUMAN PRESCRIPTION DRUG Nabumetone Nabumentone TABLET ORAL 20020225 ANDA ANDA075280 Eon Labs, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0185-0149_d9dd022c-e8cf-4b31-948b-8f8beb556dcb 0185-0149 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20020702 ANDA ANDA076514 Eon Labs, Inc. MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0185-0150_cd03e2cc-e45d-478b-b40f-c931fe874b56 0185-0150 HUMAN PRESCRIPTION DRUG nizatidine nizatidine CAPSULE ORAL 20020705 ANDA ANDA076178 Eon Labs, Inc. NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0185-0152_46203f29-2c3b-4c25-9cd1-7d0e22ad4b0e 0185-0152 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020702 ANDA ANDA076262 Eon Labs, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0185-0157_fce8ec0f-605f-454c-91bd-534f08461eba 0185-0157 HUMAN PRESCRIPTION DRUG fluvoxamine maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20001129 ANDA ANDA075888 Eon Labs, Inc. FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0185-0170_401b80f7-8916-4421-be5f-e0647f553c88 0185-0170 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20000501 ANDA ANDA075366 Eon Labs, Inc. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC] 0185-0171_401b80f7-8916-4421-be5f-e0647f553c88 0185-0171 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20000501 ANDA ANDA075366 Eon Labs, Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 0185-0173_46203f29-2c3b-4c25-9cd1-7d0e22ad4b0e 0185-0173 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA076262 Eon Labs, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0185-0174_401b80f7-8916-4421-be5f-e0647f553c88 0185-0174 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20000501 ANDA ANDA075366 Eon Labs, Inc. SOTALOL HYDROCHLORIDE 240 mg/1 Antiarrhythmic [EPC] 0185-0177_401b80f7-8916-4421-be5f-e0647f553c88 0185-0177 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20000501 ANDA ANDA075366 Eon Labs, Inc. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC] 0185-0193_7e7898d4-7d5a-44cd-9087-9445695ded53 0185-0193 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077644 Eon Labs, Inc. ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0185-0199_7e7898d4-7d5a-44cd-9087-9445695ded53 0185-0199 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077644 Eon Labs, Inc. ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0185-0200_7e7898d4-7d5a-44cd-9087-9445695ded53 0185-0200 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077644 Eon Labs, Inc. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0185-0204_7c44f0c9-46b4-4ad6-aa20-1b451da9651a 0185-0204 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 20150930 ANDA ANDA076631 Eon Labs, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0185-0205_41f340e0-8806-41dd-984b-71a82643a037 0185-0205 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20010327 ANDA ANDA040411 Eon Labs, Inc. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 0185-0210_41f340e0-8806-41dd-984b-71a82643a037 0185-0210 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20010327 ANDA ANDA040411 Eon Labs, Inc. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 0185-0211_7c44f0c9-46b4-4ad6-aa20-1b451da9651a 0185-0211 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076631 Eon Labs, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0185-0212_ebec0e13-3c1e-457b-b95d-02fdafcd173b 0185-0212 HUMAN PRESCRIPTION DRUG mirtazapine mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076219 Eon Labs, Inc. MIRTAZAPINE 30 mg/1 0185-0213_0a0bb8b4-6322-499b-a201-e682a79641a7 0185-0213 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20020125 ANDA ANDA075965 Eon Labs, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0185-0215_0a0bb8b4-6322-499b-a201-e682a79641a7 0185-0215 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20020125 ANDA ANDA075965 Eon Labs, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0185-0221_0a0bb8b4-6322-499b-a201-e682a79641a7 0185-0221 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20020125 ANDA ANDA075965 Eon Labs, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0185-0222_ebec0e13-3c1e-457b-b95d-02fdafcd173b 0185-0222 HUMAN PRESCRIPTION DRUG mirtazapine mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076219 Eon Labs, Inc. MIRTAZAPINE 45 mg/1 0185-0223_e5221d69-4897-4884-a283-726b8485f1e7 0185-0223 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20041123 ANDA ANDA077021 Eon Labs, Inc. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0185-0277_7c44f0c9-46b4-4ad6-aa20-1b451da9651a 0185-0277 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076631 Eon Labs, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0185-0300_cd03e2cc-e45d-478b-b40f-c931fe874b56 0185-0300 HUMAN PRESCRIPTION DRUG nizatidine nizatidine CAPSULE ORAL 20020705 ANDA ANDA076178 Eon Labs, Inc. NIZATIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0185-0325_7c44f0c9-46b4-4ad6-aa20-1b451da9651a 0185-0325 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20140314 ANDA ANDA076631 Eon Labs, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0185-0341_114dc847-8ad5-47c2-ad22-6efd5b73f9a6 0185-0341 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20050928 ANDA ANDA076961 Eon Labs, Inc. FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0185-0342_114dc847-8ad5-47c2-ad22-6efd5b73f9a6 0185-0342 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20050928 ANDA ANDA076961 Eon Labs, Inc. FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0185-0371_7135ba86-24ce-4783-aebd-1768afcb40a0 0185-0371 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Eon Labs, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0185-0372_7135ba86-24ce-4783-aebd-1768afcb40a0 0185-0372 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Eon Labs, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0185-0373_7135ba86-24ce-4783-aebd-1768afcb40a0 0185-0373 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Eon Labs, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0185-0401_6b7d6ab8-b9ee-40db-a0b0-715194f69d32 0185-0401 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020614 ANDA ANDA040439 Eon Labs, Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0185-0404_6b7d6ab8-b9ee-40db-a0b0-715194f69d32 0185-0404 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020614 ANDA ANDA040439 Eon Labs, Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0185-0410_713eee9f-d4e9-4c17-8ec1-dca1fd4fbc15 0185-0410 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20031125 ANDA ANDA075932 Eon Labs, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0185-0415_713eee9f-d4e9-4c17-8ec1-dca1fd4fbc15 0185-0415 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20040322 ANDA ANDA075932 Eon Labs, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0185-0448_641bddd9-e57f-4731-9029-6f4c4f35cf0d 0185-0448 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20100331 ANDA ANDA040445 Eon Labs, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0185-0505_937be6ce-4d33-4eb0-80e9-6ec7467c3c34 0185-0505 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076402 Eon Labs, Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0185-0550_fc6f1487-c72a-4136-8286-79a7628b7a9a 0185-0550 HUMAN PRESCRIPTION DRUG itraconazole itraconazole CAPSULE ORAL 20040528 ANDA ANDA076104 Eon Labs, Inc. ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0185-0613_49fdcd63-2db7-42cf-ad51-fbe2af84f712 0185-0613 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 20190410 ANDA ANDA087479 Eon Labs, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0185-0615_49fdcd63-2db7-42cf-ad51-fbe2af84f712 0185-0615 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA086183 Eon Labs, Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0185-0644_9879efb7-faa3-4e4a-bf31-7e5e503e3f8a 0185-0644 HUMAN PRESCRIPTION DRUG phentermine hydrochloride phentermine hydrochloride CAPSULE ORAL 19810612 ANDA ANDA087190 Eon Labs, Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0185-0647_9879efb7-faa3-4e4a-bf31-7e5e503e3f8a 0185-0647 HUMAN PRESCRIPTION DRUG phentermine hydrochloride phentermine hydrochloride CAPSULE ORAL 19810612 ANDA ANDA087190 Eon Labs, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0185-0648_c9304698-6e7e-418a-893e-39a199d09e25 0185-0648 HUMAN OTC DRUG diphenhydramine hydrochloride diphenhydramine hydrochloride CAPSULE ORAL 20000501 OTC MONOGRAPH FINAL part341 Eon Labs, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0185-0649_c9304698-6e7e-418a-893e-39a199d09e25 0185-0649 HUMAN OTC DRUG diphenhydramine hydrochloride diphenhydramine hydrochloride CAPSULE ORAL 20000501 OTC MONOGRAPH FINAL part341 Eon Labs, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 0185-0674_49fdcd63-2db7-42cf-ad51-fbe2af84f712 0185-0674 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20140627 ANDA ANDA087479 Eon Labs, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0185-0701_45fddb97-5c5d-4607-ae77-08b5a34ddd75 0185-0701 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20000925 ANDA ANDA075579 Eon Labs, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0185-0704_45fddb97-5c5d-4607-ae77-08b5a34ddd75 0185-0704 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20000925 ANDA ANDA075579 Eon Labs, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0185-0707_45fddb97-5c5d-4607-ae77-08b5a34ddd75 0185-0707 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20000925 ANDA ANDA075579 Eon Labs, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0185-0720_d9a8d5d8-74f3-4533-83f7-9d9c99822b65 0185-0720 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 19980528 ANDA ANDA074464 Eon Labs, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0185-0724_501b39a2-0b88-4277-89a1-45b61cdad1bf 0185-0724 HUMAN PRESCRIPTION DRUG Carisoprodol and Aspirin Carisoprodol and Aspirin TABLET ORAL 19960425 ANDA ANDA040116 Eon Labs, Inc. ASPIRIN; CARISOPRODOL 325; 200 mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIV 0185-0749_a6b304e5-073f-48b6-9f17-ddfa94ecf2db 0185-0749 HUMAN PRESCRIPTION DRUG Carisoprodol, Aspirin and Codeine Phosphate Carisoprodol, Aspirin and Codeine Phosphate TABLET ORAL 19960416 ANDA ANDA040118 Eon Labs, Inc. ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE 325; 200; 16 mg/1; mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0185-0757_33de8c40-410d-4f79-8086-614c2dfed025 0185-0757 HUMAN PRESCRIPTION DRUG Sulfadiazine Sulfadiazine TABLET ORAL 19940729 ANDA ANDA040091 Eon Labs, Inc. SULFADIAZINE 500 mg/1 Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0185-0771_b73ef1f0-b0f7-443e-81a3-b6dd20367f3a 0185-0771 HUMAN PRESCRIPTION DRUG bisoprolol fumarate bisoprolol fumarate TABLET, COATED ORAL 20001116 ANDA ANDA075643 Eon Labs, Inc. BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0185-0774_b73ef1f0-b0f7-443e-81a3-b6dd20367f3a 0185-0774 HUMAN PRESCRIPTION DRUG bisoprolol fumarate bisoprolol fumarate TABLET, COATED ORAL 20001116 ANDA ANDA075643 Eon Labs, Inc. BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0185-0799_8db5bef1-33c2-4d65-a655-8f5546936b69 0185-0799 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 19970528 ANDA ANDA064150 Eon Labs, Inc. RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 0185-0801_8db5bef1-33c2-4d65-a655-8f5546936b69 0185-0801 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 19980102 ANDA ANDA064150 Eon Labs, Inc. RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 0185-0820_937be6ce-4d33-4eb0-80e9-6ec7467c3c34 0185-0820 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076402 Eon Labs, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0185-0932_724d0555-2d54-434f-a5e9-0cb3b24d7b4a 0185-0932 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE ORAL 20000113 ANDA ANDA065017 Eon Labs, Inc. CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0185-0933_724d0555-2d54-434f-a5e9-0cb3b24d7b4a 0185-0933 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE ORAL 20000113 ANDA ANDA065017 Eon Labs, Inc. CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0185-0939_b00414ee-6b9a-4217-a805-dd8d7b65fceb 0185-0939 HUMAN PRESCRIPTION DRUG cholestyramine light cholestyramine light POWDER, FOR SUSPENSION ORAL 19941104 ANDA ANDA074558 Eon Labs, Inc. CHOLESTYRAMINE 4 g/5.7g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 0185-0940_7032ad06-da47-4528-80ef-3557d2ee3cd7 0185-0940 HUMAN PRESCRIPTION DRUG Cholestyramine Cholestyramine POWDER, FOR SUSPENSION ORAL 19960815 ANDA ANDA074557 Eon Labs, Inc. CHOLESTYRAMINE 4 g/9g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 0185-1047_ffaceca5-e8c0-4b82-8f3b-582521f30fba 0185-1047 HUMAN PRESCRIPTION DRUG Quinidine Sulfate Quinidine Sulfate TABLET ORAL 19830926 ANDA ANDA088072 Eon Labs, Inc. QUINIDINE SULFATE 300 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] 0185-1111_713eee9f-d4e9-4c17-8ec1-dca1fd4fbc15 0185-1111 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20050622 ANDA ANDA075932 Eon Labs, Inc. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0185-4057_4831ce38-03bc-447e-8435-02eaf8696157 0185-4057 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 19970819 ANDA ANDA085588 Eon Labs, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 0185-4346_ffaceca5-e8c0-4b82-8f3b-582521f30fba 0185-4346 HUMAN PRESCRIPTION DRUG Quinidine Sulfate Quinidine Sulfate TABLET ORAL 19761124 ANDA ANDA088072 Eon Labs, Inc. QUINIDINE SULFATE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] 0185-4350_bd9a4b5c-a1de-4759-a8b4-ff5e322f79a3 0185-4350 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19781211 NDA NDA008678 Eon Labs, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] 0185-4351_bd9a4b5c-a1de-4759-a8b4-ff5e322f79a3 0185-4351 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19781211 NDA NDA008678 Eon Labs, Inc. ISONIAZID 100 mg/1 Antimycobacterial [EPC] 0185-4400_bb87771f-5105-4c5e-825c-0221523fb7c6 0185-4400 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride TABLET ORAL 20020627 ANDA ANDA076280 Eon Labs, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0185-4416_d410d562-e341-47a9-b9ca-258004c808b2 0185-4416 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20041214 ANDA ANDA076873 Eon Labs, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0185-5000_9879efb7-faa3-4e4a-bf31-7e5e503e3f8a 0185-5000 HUMAN PRESCRIPTION DRUG phentermine hydrochloride phentermine hydrochloride CAPSULE ORAL 19810612 ANDA ANDA087190 Eon Labs, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0185-5050_a75a7b62-e163-4a4f-adc2-2db73f429239 0185-5050 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20031219 ANDA ANDA076732 Eon Labs, Inc. METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0185-5254_be93c2d6-0c89-4171-a881-29feeeb949e6 0185-5254 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate CAPSULE, EXTENDED RELEASE ORAL 19770906 NDA NDA018074 Eon Labs, Inc. PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 0185-5368_31417289-8b26-4c9b-a968-879dab5587d9 0185-5368 HUMAN PRESCRIPTION DRUG Eplerenone Eplerenone TABLET ORAL 20080801 ANDA ANDA078510 Eon Labs, Inc. EPLERENONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0185-5369_31417289-8b26-4c9b-a968-879dab5587d9 0185-5369 HUMAN PRESCRIPTION DRUG Eplerenone Eplerenone TABLET ORAL 20080801 ANDA ANDA078510 Eon Labs, Inc. EPLERENONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0185-5400_57da7501-d1bd-4304-9508-79af23bfd52c 0185-5400 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Eon Labs, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0185-5600_a75a7b62-e163-4a4f-adc2-2db73f429239 0185-5600 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20031219 ANDA ANDA076466 Eon Labs, Inc. METOLAZONE 10 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0185-7100_46203f29-2c3b-4c25-9cd1-7d0e22ad4b0e 0185-7100 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA076262 Eon Labs, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0185-7322_033ee32c-9a53-4fdd-ac28-dddce389fb60 0185-7322 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate ipratropium bromide and albuterol sulfate SOLUTION RESPIRATORY (INHALATION) 20010321 NDA NDA020950 Eon Labs, Inc. ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 3; .5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0185-7400_db12d309-92e5-47f0-84d7-aba74956f6e0 0185-7400 HUMAN PRESCRIPTION DRUG Leuprolide Acetate Leuprolide Acetate INJECTION, SOLUTION SUBCUTANEOUS 19980804 ANDA ANDA074728 Eon Labs, Inc. LEUPROLIDE ACETATE 1 mg/.2mL Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] 0186-0004_6abc915a-163a-4e85-a6e6-ce7231b3f4ad 0186-0004 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914 NDA NDA020838 AstraZeneca LP CANDESARTAN CILEXETIL 4 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0186-0008_6abc915a-163a-4e85-a6e6-ce7231b3f4ad 0186-0008 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914 NDA NDA020838 AstraZeneca LP CANDESARTAN CILEXETIL 8 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0186-0016_6abc915a-163a-4e85-a6e6-ce7231b3f4ad 0186-0016 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914 NDA NDA020838 AstraZeneca LP CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0186-0032_6abc915a-163a-4e85-a6e6-ce7231b3f4ad 0186-0032 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914 NDA NDA020838 AstraZeneca LP CANDESARTAN CILEXETIL 32 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0186-0162_4d3c2520-111f-4263-9bfc-218e7c2d3cc5 0186-0162 HUMAN PRESCRIPTION DRUG ATACAND HCT Candesartan cilexetil and Hydrochlorothiazide TABLET ORAL 20000928 NDA NDA021093 AstraZeneca LP CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 16; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0186-0322_4d3c2520-111f-4263-9bfc-218e7c2d3cc5 0186-0322 HUMAN PRESCRIPTION DRUG ATACAND HCT Candesartan cilexetil and Hydrochlorothiazide TABLET ORAL 20000928 NDA NDA021093 AstraZeneca LP CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0186-0324_4d3c2520-111f-4263-9bfc-218e7c2d3cc5 0186-0324 HUMAN PRESCRIPTION DRUG ATACAND HCT Candesartan cilexetil Hydrochlorothiazide TABLET ORAL 20080902 NDA NDA021093 AstraZeneca LP CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0186-0370_27d7a2ed-c38a-42af-a9f9-57fe258d2d9e 0186-0370 HUMAN PRESCRIPTION DRUG SYMBICORT Budesonide and Formoterol Fumarate Dihydrate AEROSOL RESPIRATORY (INHALATION) 20070529 NDA NDA021929 AstraZeneca LP BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE 160; 4.5 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0186-0372_27d7a2ed-c38a-42af-a9f9-57fe258d2d9e 0186-0372 HUMAN PRESCRIPTION DRUG SYMBICORT Budesonide and Formoterol Fumarate Dihydrate AEROSOL RESPIRATORY (INHALATION) 20070529 NDA NDA021929 AstraZeneca LP BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE 80; 4.5 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0186-0450_61f6ed30-f9dc-4caa-a120-54969ed3091e 0186-0450 HUMAN PRESCRIPTION DRUG PLENDIL Felodipine TABLET, EXTENDED RELEASE ORAL 19941004 NDA NDA019834 AstraZeneca LP FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0186-0451_61f6ed30-f9dc-4caa-a120-54969ed3091e 0186-0451 HUMAN PRESCRIPTION DRUG PLENDIL Felodipine TABLET, EXTENDED RELEASE ORAL 19910916 NDA NDA019834 AstraZeneca LP FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0186-0452_61f6ed30-f9dc-4caa-a120-54969ed3091e 0186-0452 HUMAN PRESCRIPTION DRUG PLENDIL Felodipine TABLET, EXTENDED RELEASE ORAL 19910916 NDA NDA019834 AstraZeneca LP FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0186-0510_94e8108f-5c9d-4252-8c0a-95d196e6f784 0186-0510 HUMAN PRESCRIPTION DRUG VIMOVO naproxen and esomeprazole magnesium TABLET, DELAYED RELEASE ORAL 20100706 NDA NDA022511 AstraZeneca LP ESOMEPRAZOLE MAGNESIUM; NAPROXEN 20; 375 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-0520_94e8108f-5c9d-4252-8c0a-95d196e6f784 0186-0520 HUMAN PRESCRIPTION DRUG VIMOVO naproxen and esomeprazole magnesium TABLET, DELAYED RELEASE ORAL 20100706 NDA NDA022511 AstraZeneca LP ESOMEPRAZOLE MAGNESIUM; NAPROXEN 20; 500 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-0606_00b7d931-923e-4fdb-9736-e75e96ad3859 0186-0606 HUMAN PRESCRIPTION DRUG PRILOSEC Omeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 19951115 NDA NDA019810 AstraZeneca LP OMEPRAZOLE MAGNESIUM 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-0610_00b7d931-923e-4fdb-9736-e75e96ad3859 0186-0610 HUMAN PRESCRIPTION DRUG PRILOSEC Omeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20020209 NDA NDA022056 AstraZeneca LP OMEPRAZOLE MAGNESIUM 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-0625_00b7d931-923e-4fdb-9736-e75e96ad3859 0186-0625 HUMAN PRESCRIPTION DRUG PRILOSEC Omeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20020209 NDA NDA022056 AstraZeneca LP OMEPRAZOLE MAGNESIUM 2.5 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-0702_e164e160-3021-4d1c-97c6-71b1b082525f 0186-0702 HUMAN PRESCRIPTION DRUG ENTOCORT EC Budesonide CAPSULE ORAL 20011029 NDA NDA021234 AstraZeneca LP BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0186-0742_00b7d931-923e-4fdb-9736-e75e96ad3859 0186-0742 HUMAN PRESCRIPTION DRUG PRILOSEC Omeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 19901001 NDA NDA019810 AstraZeneca LP OMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-0743_00b7d931-923e-4fdb-9736-e75e96ad3859 0186-0743 HUMAN PRESCRIPTION DRUG PRILOSEC Omeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 19980608 NDA NDA019810 AstraZeneca LP OMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-0777_2903d56b-ba8e-4428-bba3-e33a3d9630b2 0186-0777 HUMAN PRESCRIPTION DRUG BRILINTA Ticagrelor TABLET ORAL 20110805 NDA NDA022433 AstraZeneca LP TICAGRELOR 90 mg/1 P2Y12 Platelet Inhibitor [EPC],Phenylalanine Hydroxylase Activators [MoA],Decreased Platelet Aggregation [PE],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0186-0916_bcc98d74-44e4-4526-9edf-3ca577b2add2 0186-0916 HUMAN PRESCRIPTION DRUG PULMICORT FLEXHALER Budesonide AEROSOL, POWDER RESPIRATORY (INHALATION) 20070319 NDA NDA021949 AstraZeneca LP BUDESONIDE 180 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0186-0917_bcc98d74-44e4-4526-9edf-3ca577b2add2 0186-0917 HUMAN PRESCRIPTION DRUG PULMICORT FLEXHALER Budesonide AEROSOL, POWDER RESPIRATORY (INHALATION) 20070319 NDA NDA021949 AstraZeneca LP BUDESONIDE 90 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0186-1070_db4ce2c5-a1a2-4f37-bb4a-e99d01bce1fb 0186-1070 HUMAN PRESCRIPTION DRUG RHINOCORT AQUA Budesonide SPRAY, METERED NASAL 20010402 NDA NDA020746 AstraZeneca LP BUDESONIDE 32 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0186-1073_8b2657a9-5510-439f-affd-131b23bb28c4 0186-1073 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SPRAY, METERED NASAL 20140513 NDA NDA020746 AstraZeneca LP BUDESONIDE 32 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0186-1087_044641f6-8d64-4fb4-3b94-639dba979043 0186-1087 HUMAN PRESCRIPTION DRUG Dutoprol metoprolol succinate and hydrochlorothiazide TABLET, FILM COATED ORAL 20110916 NDA NDA021956 AstraZeneca LP HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE 12.5; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0186-1088_ff5e8364-a115-475f-a0ad-2e7c300b1990 0186-1088 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20010326 NDA NDA019962 AstraZeneca LP METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0186-1090_ff5e8364-a115-475f-a0ad-2e7c300b1990 0186-1090 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 19920201 NDA NDA019962 AstraZeneca LP METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0186-1092_ff5e8364-a115-475f-a0ad-2e7c300b1990 0186-1092 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 19920201 NDA NDA019962 AstraZeneca LP METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0186-1094_ff5e8364-a115-475f-a0ad-2e7c300b1990 0186-1094 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 19920201 NDA NDA019962 AstraZeneca LP METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0186-1095_044641f6-8d64-4fb4-3b94-639dba979043 0186-1095 HUMAN PRESCRIPTION DRUG Dutoprol metoprolol succinate and hydrochlorothiazide TABLET, FILM COATED ORAL 20110916 NDA NDA021956 AstraZeneca LP HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE 12.5; 50 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0186-1097_044641f6-8d64-4fb4-3b94-639dba979043 0186-1097 HUMAN PRESCRIPTION DRUG Dutoprol metoprolol succinate and hydrochlorothiazide TABLET, FILM COATED ORAL 20110916 NDA NDA021956 AstraZeneca LP HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE 12.5; 100 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0186-1988_37814a0a-646e-44b1-bb71-323bab776259 0186-1988 HUMAN PRESCRIPTION DRUG PULMICORT RESPULES Budesonide SUSPENSION RESPIRATORY (INHALATION) 20000908 NDA NDA020929 AstraZeneca LP BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0186-1989_37814a0a-646e-44b1-bb71-323bab776259 0186-1989 HUMAN PRESCRIPTION DRUG PULMICORT RESPULES Budesonide SUSPENSION RESPIRATORY (INHALATION) 20000908 NDA NDA020929 AstraZeneca LP BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0186-1990_37814a0a-646e-44b1-bb71-323bab776259 0186-1990 HUMAN PRESCRIPTION DRUG PULMICORT RESPULES Budesonide SUSPENSION RESPIRATORY (INHALATION) 20070917 NDA NDA020929 AstraZeneca LP BUDESONIDE 1 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0186-4010_2419e97d-8ed0-4a3f-8f6a-411d46018716 0186-4010 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20080707 NDA NDA022101 AstraZeneca LP ESOMEPRAZOLE MAGNESIUM 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-4020_2419e97d-8ed0-4a3f-8f6a-411d46018716 0186-4020 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20070319 NDA NDA021957 AstraZeneca LP ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-4025_2419e97d-8ed0-4a3f-8f6a-411d46018716 0186-4025 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20120601 NDA NDA021957 AstraZeneca LP ESOMEPRAZOLE MAGNESIUM 2.5 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-4040_2419e97d-8ed0-4a3f-8f6a-411d46018716 0186-4040 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20070319 NDA NDA021957 AstraZeneca LP ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-4050_2419e97d-8ed0-4a3f-8f6a-411d46018716 0186-4050 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20120601 NDA NDA021957 AstraZeneca LP ESOMEPRAZOLE MAGNESIUM 5 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-5020_2419e97d-8ed0-4a3f-8f6a-411d46018716 0186-5020 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010319 NDA NDA021153 AstraZeneca LP ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-5022_2419e97d-8ed0-4a3f-8f6a-411d46018716 0186-5022 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010319 NDA NDA021153 AstraZeneca LP ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-5040_2419e97d-8ed0-4a3f-8f6a-411d46018716 0186-5040 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010319 NDA NDA021153 AstraZeneca LP ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-5042_2419e97d-8ed0-4a3f-8f6a-411d46018716 0186-5042 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010319 NDA NDA021153 AstraZeneca LP ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-6020_64c661b3-bb99-45fe-bb40-9aa2ced68f07 0186-6020 HUMAN PRESCRIPTION DRUG NEXIUM I.V. Esomeprazole sodium INJECTION INTRAVENOUS 20050503 NDA NDA021689 AstraZeneca LP ESOMEPRAZOLE SODIUM 20 mg/5mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0186-6040_64c661b3-bb99-45fe-bb40-9aa2ced68f07 0186-6040 HUMAN PRESCRIPTION DRUG NEXIUM I.V. Esomeprazole sodium INJECTION INTRAVENOUS 20050503 NDA NDA021689 AstraZeneca LP ESOMEPRAZOLE SODIUM 40 mg/5mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0187-0003_c18321c4-1588-440c-b319-a22705847d8d 0187-0003 HUMAN PRESCRIPTION DRUG CAPITAL AND CODEINE Acetaminophen and codeine phosphate SUSPENSION ORAL 20040503 ANDA ANDA086024 Valeant Pharmaceuticals International ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 0187-0007_36b43bbc-8b1d-4253-99f8-31d24bad5d4a 0187-0007 HUMAN PRESCRIPTION DRUG Virazole Ribavirin POWDER, FOR SOLUTION RESPIRATORY (INHALATION) 19860101 NDA NDA018859 Valeant Pharmaceuticals North America LLC RIBAVIRIN 6 g/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 0187-0054_571c1b83-2fde-4339-be0c-cac0dedaf76c 0187-0054 HUMAN PRESCRIPTION DRUG TussiCaps hydrocodone polistirex and chlorpheniramine polistirex CAPSULE, EXTENDED RELEASE ORAL 20110902 ANDA ANDA077273 VALEANT PHARMACEUTICALS NORTH AMERICA LLC CHLORPHENIRAMINE; HYDROCODONE 4; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII 0187-0063_89057c93-8155-4040-acec-64e877bd2b4c 0187-0063 HUMAN PRESCRIPTION DRUG Ativan lorazepam TABLET ORAL 20130501 NDA NDA017794 Valeant Pharmaceuticals North America LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0187-0064_89057c93-8155-4040-acec-64e877bd2b4c 0187-0064 HUMAN PRESCRIPTION DRUG Ativan lorazepam TABLET ORAL 20130501 NDA NDA017794 Valeant Pharmaceuticals North America LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0187-0065_89057c93-8155-4040-acec-64e877bd2b4c 0187-0065 HUMAN PRESCRIPTION DRUG Ativan lorazepam TABLET ORAL 20130501 NDA NDA017794 Valeant Pharmaceuticals North America LLC LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0187-0108_571c1b83-2fde-4339-be0c-cac0dedaf76c 0187-0108 HUMAN PRESCRIPTION DRUG TussiCaps hydrocodone polistirex and chlorpheniramine polistirex CAPSULE, EXTENDED RELEASE ORAL 20110902 ANDA ANDA077273 VALEANT PHARMACEUTICALS NORTH AMERICA LLC CHLORPHENIRAMINE; HYDROCODONE 8; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII 0187-0140_9ed90e7c-043d-4aee-bee7-d4cb24d7dcf9 0187-0140 HUMAN PRESCRIPTION DRUG Vasotec Enalapril Maleate TABLET ORAL 19880726 NDA NDA018998 Valeant Pharmaceuticals North America LLC ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0187-0141_9ed90e7c-043d-4aee-bee7-d4cb24d7dcf9 0187-0141 HUMAN PRESCRIPTION DRUG Vasotec Enalapril Maleate TABLET ORAL 19851224 NDA NDA018998 Valeant Pharmaceuticals North America LLC ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0187-0142_9ed90e7c-043d-4aee-bee7-d4cb24d7dcf9 0187-0142 HUMAN PRESCRIPTION DRUG Vasotec Enalapril Maleate TABLET ORAL 19851224 NDA NDA018998 Valeant Pharmaceuticals North America LLC ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0187-0143_9ed90e7c-043d-4aee-bee7-d4cb24d7dcf9 0187-0143 HUMAN PRESCRIPTION DRUG Vasotec Enalapril Maleate TABLET ORAL 19851224 NDA NDA018998 Valeant Pharmaceuticals North America LLC ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0187-0146_9416bd27-b7d5-4165-9b54-53e14249291c 0187-0146 HUMAN PRESCRIPTION DRUG Vaseretic enalapril maleate and hydrochlorothiazide TABLET ORAL 19861031 NDA NDA019221 Valeant Pharmaceuticals North America LLC ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0187-0152_8ddd2577-311a-4967-bb67-ad72e2b76f83 0187-0152 HUMAN PRESCRIPTION DRUG Isordil Titradose isosorbide dinitrate TABLET ORAL 20130401 NDA NDA012093 Valeant Pharmaceuticals North America LLC ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0187-0192_8ddd2577-311a-4967-bb67-ad72e2b76f83 0187-0192 HUMAN PRESCRIPTION DRUG Isordil Titradose isosorbide dinitrate TABLET ORAL 20130401 NDA NDA012093 Valeant Pharmaceuticals North America LLC ISOSORBIDE DINITRATE 40 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0187-0245_a5c8010a-c55d-4fbd-aea5-701617359f78 0187-0245 HUMAN PRESCRIPTION DRUG Migranal dihydroergotamine mesylate SPRAY NASAL 19971208 NDA NDA020148 Valeant Pharmaceuticals North America LLC DIHYDROERGOTAMINE MESYLATE 4 mg/mL Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient] 0187-0402_01b27f86-8227-4f72-a51b-4d5394239173 0187-0402 HUMAN PRESCRIPTION DRUG Oxsoralen Methoxsalen LOTION TOPICAL 19541203 20160630 NDA NDA009048 Valeant Pharmaceuticals North America LLC METHOXSALEN 10 mg/mL Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE],Psoralen [EPC],Psoralens [Chemical/Ingredient] 0187-0453_ef6a24db-29eb-454d-a0a5-f513513a231c 0187-0453 HUMAN PRESCRIPTION DRUG ZELAPAR SELEGILINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING ORAL 20060614 NDA NDA021479 Valeant Pharmaceuticals North America LLC SELEGILINE HYDROCHLORIDE 1.25 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] 0187-0497_608c8c09-0a7e-4bc7-8d0d-8181d16fe23a 0187-0497 HUMAN PRESCRIPTION DRUG Bontril PDM Phendimetrazine Tartrate TABLET ORAL 19761222 20150731 ANDA ANDA085272 Valeant Pharmaceuticals International PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 0187-0650_5ff2b0f8-9870-4f20-8d28-1ff975ae8274 0187-0650 HUMAN PRESCRIPTION DRUG Oxsoralen-Ultra Methoxsalen CAPSULE, LIQUID FILLED ORAL 19861030 NDA NDA019600 Valeant Pharmaceuticals North America LLC METHOXSALEN 10 mg/1 Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE],Psoralen [EPC],Psoralens [Chemical/Ingredient] 0187-0651_3855ec30-3fe3-4016-8943-c068a74d9d12 0187-0651 HUMAN PRESCRIPTION DRUG 8-MOP Methoxsalen CAPSULE, GELATIN COATED ORAL 19541203 20200101 NDA NDA009048 Valeant Pharmaceuticals North America LLC METHOXSALEN 10 mg/1 Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE],Psoralen [EPC],Psoralens [Chemical/Ingredient] 0187-0658_befe8a8c-72be-40ad-94f9-537feb0fbbda 0187-0658 HUMAN PRESCRIPTION DRUG Diastat diazepam GEL RECTAL 19970729 NDA NDA020648 Valeant Pharmaceuticals North America LLC DIAZEPAM 10 mg/2mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0187-0659_befe8a8c-72be-40ad-94f9-537feb0fbbda 0187-0659 HUMAN PRESCRIPTION DRUG Diastat diazepam GEL RECTAL 19970729 NDA NDA020648 Valeant Pharmaceuticals North America LLC DIAZEPAM 20 mg/4mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0187-0730_3c719a57-99f7-4253-9be3-52a6b065c9e3 0187-0730 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20091223 NDA NDA021515 Valeant Pharmaceuticals North America LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0187-0731_3c719a57-99f7-4253-9be3-52a6b065c9e3 0187-0731 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20091223 NDA NDA021515 Valeant Pharmaceuticals North America LLC BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0187-0771_76f49f6b-2f83-48e8-b07f-4bad60293c2c 0187-0771 HUMAN PRESCRIPTION DRUG Cardizem Diltiazem Hydrochloride TABLET, COATED ORAL 20101225 NDA NDA018602 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-0772_76f49f6b-2f83-48e8-b07f-4bad60293c2c 0187-0772 HUMAN PRESCRIPTION DRUG Cardizem Diltiazem Hydrochloride TABLET, COATED ORAL 20101225 NDA NDA018602 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-0792_76f49f6b-2f83-48e8-b07f-4bad60293c2c 0187-0792 HUMAN PRESCRIPTION DRUG Cardizem Diltiazem Hydrochloride TABLET, COATED ORAL 20101225 NDA NDA018602 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-0795_31167b47-0d95-475c-95b8-94cb61454b4a 0187-0795 HUMAN PRESCRIPTION DRUG Cardizem CD Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20010411 NDA NDA020062 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-0796_31167b47-0d95-475c-95b8-94cb61454b4a 0187-0796 HUMAN PRESCRIPTION DRUG Cardizem CD Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20010411 NDA NDA020062 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-0797_31167b47-0d95-475c-95b8-94cb61454b4a 0187-0797 HUMAN PRESCRIPTION DRUG Cardizem CD Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20010411 NDA NDA020062 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-0798_31167b47-0d95-475c-95b8-94cb61454b4a 0187-0798 HUMAN PRESCRIPTION DRUG Cardizem CD Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20010411 NDA NDA020062 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-0799_31167b47-0d95-475c-95b8-94cb61454b4a 0187-0799 HUMAN PRESCRIPTION DRUG Cardizem CD Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20010411 NDA NDA020062 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-0842_06ca1780-a53c-40db-9b28-794d99d75c52 0187-0842 HUMAN PRESCRIPTION DRUG Phrenilin Butalbital and Acetaminophen TABLET ORAL 20040503 ANDA ANDA087811 Valeant Pharmaceuticals North America LLC ACETAMINOPHEN; BUTALBITAL 325; 50 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] 0187-0844_06ca1780-a53c-40db-9b28-794d99d75c52 0187-0844 HUMAN PRESCRIPTION DRUG Phrenilin Forte Butalbital and Acetaminophen CAPSULE ORAL 20040503 20160930 ANDA ANDA088831 Valeant Pharmaceuticals North America LLC ACETAMINOPHEN; BUTALBITAL 650; 50 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] 0187-0901_eb4f5663-44ba-4b7b-898c-740e22a09bca 0187-0901 HUMAN PRESCRIPTION DRUG Testred C-III MethylTESTOSTERone CAPSULE ORAL 19731203 20170101 ANDA ANDA083976 Valeant Pharmaceuticals North America LLC METHYLTESTOSTERONE 10 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0187-0902_0e285011-438a-4d53-a571-6737ee380eeb 0187-0902 HUMAN PRESCRIPTION DRUG Android MethylTESTOSTERone CAPSULE ORAL 19731203 20170101 ANDA ANDA083976 Valeant Pharmaceuticals North America LLC METHYLTESTOSTERONE 10 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0187-0938_25424afb-0cc5-4ba0-80ad-bc91bf4a0d21 0187-0938 HUMAN PRESCRIPTION DRUG Tasmar Tolcapone TABLET, FILM COATED ORAL 20040727 NDA NDA020697 Valeant Pharmaceuticals North America LLC TOLCAPONE 100 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0187-0993_f9dde4e5-6cec-49dc-8787-f39f4e46472f 0187-0993 HUMAN PRESCRIPTION DRUG Zovirax acyclovir OINTMENT TOPICAL 19820329 NDA NDA018604 Valeant Pharmaceuticals North America LLC ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0187-0994_9ba733ad-5129-4290-9598-21375de2713a 0187-0994 HUMAN PRESCRIPTION DRUG Zovirax acyclovir CREAM TOPICAL 20021230 NDA NDA021478 Valeant Pharmaceuticals North America LLC ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0187-1101_7a62cb1f-0cd0-44b5-9c73-b2a10914036e 0187-1101 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20090801 20160531 NDA NDA022070 Valeant Pharmaceuticals North America LLC TRETINOIN .05 g/100g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0187-1221_01c46f44-14ff-4510-89cb-84114ce439de 0187-1221 HUMAN PRESCRIPTION DRUG Cesamet NABILONE CAPSULE ORAL 20091101 NDA NDA018677 Valeant Pharmaceuticals North America NABILONE 1 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CII 0187-1366_c079f4b9-4f74-41f1-a43e-013c6f4f6c6e 0187-1366 HUMAN OTC DRUG CeraVe AM Sunscreen Broad Spectrum 30 SPF Homosalate, Octinoxate, Zinc Oxide, and Octocrylene LOTION TOPICAL 20121002 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 124; 77; 21; 36 mg/mL; mg/mL; mg/mL; mg/mL 0187-1605_2856b11a-db64-4056-aad1-fee3b789112f 0187-1605 HUMAN OTC DRUG AcneFree 2-in-1 Acne Wipes Salicylic Acid CLOTH TOPICAL 20141101 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC SALICYLIC ACID 5 mg/1 0187-1610_036591e6-bde5-4607-ba0e-4c22d49ccd63 0187-1610 HUMAN OTC DRUG AcneFree Clear Skin Treatments 24 HOUR Acne Clearing System Benzoyl Peroxide KIT 20140625 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC 0187-1611_f69eb043-0139-4c98-96a6-3977ff3910f7 0187-1611 HUMAN OTC DRUG AcneFree Clear Skin Treatments 24 HOUR Severe Acne Clearing System benzoyl peroxide KIT 20140625 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC 0187-1612_d5693b98-6fb6-42f0-b01e-b5c2651d1420 0187-1612 HUMAN OTC DRUG AcneFree Sensitive 24 HOUR Acne Clearing System Benzoyl Peroxide KIT 20140911 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC 0187-1613_1a9053a4-8f29-410b-b9a1-d5fbc7a85b6b 0187-1613 HUMAN OTC DRUG AcneFree Oil-Free Acne Cleanser benzoyl peroxide LIQUID TOPICAL 20130101 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC BENZOYL PEROXIDE 25 mg/mL 0187-1616_06635f3f-93b6-4602-9bed-f426b28f6916 0187-1616 HUMAN OTC DRUG AcneFree Severe Terminator Maximum Strength benzoyl peroxide CREAM TOPICAL 20140915 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC BENZOYL PEROXIDE 100 mg/g 0187-1617_e1907c47-bb39-489d-ae19-850cd8f9f41b 0187-1617 HUMAN OTC DRUG AcneFree Original Strength Terminator benzoyl peroxide CREAM TOPICAL 20140915 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC BENZOYL PEROXIDE 50 mg/g 0187-1618_bcf45186-b02b-461c-aa55-838d7b51900c 0187-1618 HUMAN OTC DRUG AcneFree Clear Skin Treatments Terminator 2.5 benzoyl peroxide CREAM TOPICAL 20140912 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC BENZOYL PEROXIDE 25 mg/g 0187-1619_4257c9a2-d817-49ac-8651-f53b8c622df0 0187-1619 HUMAN OTC DRUG ACNEFREE THERAPEUTIC SULFUR MASK SULFUR CREAM TOPICAL 20140909 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC SULFUR 35 g/g 0187-1640_8f6c33af-7593-4477-bc55-5497cee4e742 0187-1640 HUMAN OTC DRUG AcneFree Drying Salicylic acid LOTION TOPICAL 20141015 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC SALICYLIC ACID 10 mg/mL 0187-1704_5be7bb0a-dddb-4cb4-bf89-a8fafb726c83 0187-1704 HUMAN PRESCRIPTION DRUG Mephyton phytonadione TABLET ORAL 20130319 NDA NDA010104 Valeant Pharmaceuticals North America LLC PHYTONADIONE 5 mg/1 Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 0187-1824_4310621f-ed83-492f-8ce9-703b4aeb082f 0187-1824 HUMAN OTC DRUG Dr. Lewinn by Kinerase Sunscreen Broad Spectrum SPF 15 Octinoxate, Zinc Oxide CREAM TOPICAL 20121205 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC OCTINOXATE; ZINC OXIDE 2.88; 1.44 g/48g; g/48g 0187-2045_3e180dc7-c871-4efc-8755-cae882976c8d 0187-2045 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-2046_3e180dc7-c871-4efc-8755-cae882976c8d 0187-2046 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-2047_3e180dc7-c871-4efc-8755-cae882976c8d 0187-2047 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-2048_3e180dc7-c871-4efc-8755-cae882976c8d 0187-2048 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-2049_3e180dc7-c871-4efc-8755-cae882976c8d 0187-2049 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-2050_3e180dc7-c871-4efc-8755-cae882976c8d 0187-2050 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-2097_af8dd204-add9-4f28-8a27-e40655906456 0187-2097 HUMAN OTC DRUG Kinerase BB Cream with Kinetin Octinoxate, Zinc Oxide CREAM TOPICAL 20130902 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC OCTINOXATE; ZINC OXIDE 2.88; 1.44 g/48g; g/48g 0187-2105_4b8f9ac3-bdfe-4b3f-b7df-3d05a2dde7e7 0187-2105 HUMAN OTC DRUG KINERASE SPF 30 Broad Spectrum UVA/UVB Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20130816 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 25; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 0187-2120_c34f77a7-996b-4470-b5df-d946a7fe5dbe 0187-2120 HUMAN PRESCRIPTION DRUG Syprine trientine hydrochloride CAPSULE ORAL 19851108 NDA NDA019194 Valeant Pharmaceuticals North America LLC TRIENTINE HYDROCHLORIDE 250 mg/1 Metal Chelating Activity [MoA],Metal Chelator [EPC] 0187-2200_5bc9349c-ff3f-4257-ae41-b8dcf278787e 0187-2200 HUMAN OTC DRUG CeraVe Sunscreen Broad Spectrum SPF 30 BODY Homosalate, Meradimate, Octinoxate, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC HOMOSALATE; MERADIMATE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4.95; 4.95; 4.95; 2.48; 23.41 g/99g; g/99g; g/99g; g/99g; g/99g 0187-2201_9fa8d23b-3125-4b61-8a80-906c5d7af2ad 0187-2201 HUMAN OTC DRUG CeraVe Sunscreen Broad Spectrum SPF 30 FACE Homosalate, Meradimate, Octinoxate, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC HOMOSALATE; MERADIMATE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.5; 3.5; 3.5; 1.75; 16.56 g/70g; g/70g; g/70g; g/70g; g/70g 0187-2203_1330e8f9-6bda-49f4-ac44-275ec00e780d 0187-2203 HUMAN OTC DRUG CeraVe Sunscreen Broad Spectrum SPF 30 WET SKIN Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.23; 11.28; 5.64; 11.28; 7.05 g/141g; g/141g; g/141g; g/141g; g/141g 0187-2204_34aea768-a9b9-4220-8363-753ae6c7e261 0187-2204 HUMAN OTC DRUG CeraVe Sunscreen Broad Spectrum SPF 50 Body Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20121225 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC TITANIUM DIOXIDE; ZINC OXIDE 4.165; 3.995 g/85g; g/85g 0187-2205_460ea3b3-444e-40c2-8c00-0de6cc52eba6 0187-2205 HUMAN OTC DRUG CeraVe Sunscreen Broad Spectrum SPF 50 Face Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20121225 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC TITANIUM DIOXIDE; ZINC OXIDE 2.744; 2.632 g/56g; g/56g 0187-2206_3da9fba8-7bfd-4103-8c2f-7d93d716a541 0187-2206 HUMAN OTC DRUG CeraVe Sunscreen Broad Spectrum SPF 50 WET SKIN Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20121128 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.23; 21.15; 7.05; 14.1; 8.46 g/141g; g/141g; g/141g; g/141g; g/141g 0187-2207_beaff0a7-eb82-420d-88e3-bc672abdca3c 0187-2207 HUMAN OTC DRUG CeraVe Kids Sunscreen Broad Spectrum SPF 50 WET SKIN Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20121128 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.23; 21.15; 7.05; 14.1; 8.46 g/141g; g/141g; g/141g; g/141g; g/141g 0187-2208_5251aa24-287e-4a23-a6a7-ef6d696904f6 0187-2208 HUMAN OTC DRUG CeraVe Sunscreen Broad Spectrum SPF 50 Titanium Dioxide, Zinc Oxide STICK TOPICAL 20121203 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC TITANIUM DIOXIDE; ZINC OXIDE .8; .63 g/13.32g; g/13.32g 0187-2221_66821485-381f-406d-be55-dc0b9ee8f2c5 0187-2221 HUMAN OTC DRUG CeraVe Baby Diaper Rash Cream DIMETHICONE and ZINC OXIDE CREAM TOPICAL 20131203 OTC MONOGRAPH FINAL part347 Valeant Pharmaceuticals North America LLC DIMETHICONE; ZINC OXIDE 10; 10 mg/g; mg/g 0187-2303_331ed1de-172f-4a11-b6cf-f3dec987530c 0187-2303 HUMAN OTC DRUG Pro Therapy MD Advanced Ultra Light Day Repair Homosalate, Octinoxate, Octocrylene, and Zinc oxide LOTION TOPICAL 20111219 20150531 OTC MONOGRAPH NOT FINAL part352 Valeant Pharmaceuticals North America LLC HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 12; 7.5; 2; 5 g/100g; g/100g; g/100g; g/100g 0187-2612_c567fe7e-887e-4291-a0d1-2dd3f25cbf25 0187-2612 HUMAN PRESCRIPTION DRUG TIAZAC EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA NDA020401 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-2613_c567fe7e-887e-4291-a0d1-2dd3f25cbf25 0187-2613 HUMAN PRESCRIPTION DRUG TIAZAC EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA NDA020401 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-2614_c567fe7e-887e-4291-a0d1-2dd3f25cbf25 0187-2614 HUMAN PRESCRIPTION DRUG TIAZAC EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA NDA020401 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-2615_c567fe7e-887e-4291-a0d1-2dd3f25cbf25 0187-2615 HUMAN PRESCRIPTION DRUG TIAZAC EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA NDA020401 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-2616_c567fe7e-887e-4291-a0d1-2dd3f25cbf25 0187-2616 HUMAN PRESCRIPTION DRUG TIAZAC EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA NDA020401 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-2617_c567fe7e-887e-4291-a0d1-2dd3f25cbf25 0187-2617 HUMAN PRESCRIPTION DRUG TIAZAC EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA NDA020401 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0187-3010_b91761a5-77fd-486b-beee-728fba475756 0187-3010 HUMAN PRESCRIPTION DRUG Mestinon pyridostigmine bromide TABLET ORAL 19550406 NDA NDA009829 Valeant Pharmaceuticals North America LLC PYRIDOSTIGMINE BROMIDE 60 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0187-3012_b91761a5-77fd-486b-beee-728fba475756 0187-3012 HUMAN PRESCRIPTION DRUG Mestinon pyridostigmine bromide SYRUP ORAL 19650125 NDA NDA015193 Valeant Pharmaceuticals North America LLC PYRIDOSTIGMINE BROMIDE 60 mg/5mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0187-3013_b91761a5-77fd-486b-beee-728fba475756 0187-3013 HUMAN PRESCRIPTION DRUG Mestinon pyridostigmine bromide TABLET, EXTENDED RELEASE ORAL 19590112 NDA NDA011665 Valeant Pharmaceuticals North America LLC PYRIDOSTIGMINE BROMIDE 180 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0187-3050_5433df60-effd-44a9-9435-8e32bb167e87 0187-3050 HUMAN PRESCRIPTION DRUG ONEXTON Clindamycin Phosphate and Benzoyl Peroxide GEL TOPICAL 20141124 NDA NDA050819 Valeant Pharmaceuticals North America LLC BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 37.5; 10 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0187-3100_7fc0058e-a750-4c6e-8c5e-909ba8e449cb 0187-3100 HUMAN PRESCRIPTION DRUG Prostigmin neostigmine bromide TABLET ORAL 20040601 20150430 UNAPPROVED DRUG OTHER Valeant Pharmaceuticals North America LLC NEOSTIGMINE BROMIDE 15 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0187-3204_efb688b0-6c8c-4315-9571-e6c5cea022b0 0187-3204 HUMAN PRESCRIPTION DRUG Efudex Fluorouracil CREAM TOPICAL 19700729 NDA NDA016831 Valeant Pharmaceuticals North America LLC FLUOROURACIL 2 g/40g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0187-3554_64203ac0-dfab-4a54-b457-008751007f5c 0187-3554 HUMAN PRESCRIPTION DRUG ANCOBON Flucytosine CAPSULE ORAL 19711126 NDA NDA017001 Valeant Pharmaceuticals North America LLC FLUCYTOSINE 250 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] 0187-3555_64203ac0-dfab-4a54-b457-008751007f5c 0187-3555 HUMAN PRESCRIPTION DRUG ANCOBON Flucytosine CAPSULE ORAL 19711126 NDA NDA017001 Valeant Pharmaceuticals North America LLC FLUCYTOSINE 500 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] 0187-4100_157fd5d2-17d5-45ff-8ccc-aa186d7fca4d 0187-4100 HUMAN PRESCRIPTION DRUG Librax Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 19660901 NDA NDA012750 Valeant Pharmaceuticals International CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 0187-5010_387c6f97-65d1-4cc9-9b5b-639bdd1fa339 0187-5010 HUMAN OTC DRUG AcneFree Body Clearing Salicylic Acid SPRAY TOPICAL 20140114 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC SALICYLIC ACID 2.84 g/142g 0187-5011_1db24298-f53f-4c23-9326-59885bde6685 0187-5011 HUMAN OTC DRUG AcneFree Energizing Acne Cleanser Benzoyl Peroxide LIQUID TOPICAL 20140115 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC BENZOYL PEROXIDE 4.25 g/170g 0187-5012_86ba4987-6735-46ec-8281-93ad5b2901c9 0187-5012 HUMAN OTC DRUG AcneFree Clear Skin Treatments Advanced Deep Cleansing Duo benzoyl peroxide KIT 20140625 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC 0187-5018_5ac381f9-1724-49c3-861b-8486da5663b0 0187-5018 HUMAN OTC DRUG AcneFree Energizing Acne Wash and Scrub Benzoyl Peroxide CREAM TOPICAL 20140114 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC BENZOYL PEROXIDE 3.4 g/136g 0187-5019_59529edb-077f-485c-a4c2-24e2248066cd 0187-5019 HUMAN OTC DRUG AcneFree Energizing 3-in-1 Acne Wipes Salicylic Acid CLOTH TOPICAL 20140114 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC SALICYLIC ACID 5 mg/1 0187-5100_82f9c636-3e41-4337-8942-375b1c5abf01 0187-5100 HUMAN PRESCRIPTION DRUG ELIDEL Pimecrolimus CREAM TOPICAL 20011202 NDA NDA021302 Valeant Pharmaceuticals North America LLC PIMECROLIMUS 10 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0187-5101_82f9c636-3e41-4337-8942-375b1c5abf01 0187-5101 HUMAN PRESCRIPTION DRUG ELIDEL Pimecrolimus CREAM TOPICAL 20011202 NDA NDA021302 Valeant Pharmaceuticals North America LLC PIMECROLIMUS 10 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0187-5102_82f9c636-3e41-4337-8942-375b1c5abf01 0187-5102 HUMAN PRESCRIPTION DRUG ELIDEL Pimecrolimus CREAM TOPICAL 20011202 NDA NDA021302 Valeant Pharmaceuticals North America LLC PIMECROLIMUS 10 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0187-5103_82f9c636-3e41-4337-8942-375b1c5abf01 0187-5103 HUMAN PRESCRIPTION DRUG ELIDEL Pimecrolimus CREAM TOPICAL 20011202 NDA NDA021302 Valeant Pharmaceuticals North America LLC PIMECROLIMUS 10 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0187-5104_55989c60-a53f-45fe-a543-894782c85f91 0187-5104 HUMAN PRESCRIPTION DRUG Xerese Acyclovir and Hydrocortisone CREAM TOPICAL 20090731 NDA NDA022436 Valeant Pharmaceuticals North America LLC ACYCLOVIR; HYDROCORTISONE 50; 10 mg/g; mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0187-5115_6bfa4c28-87d4-4acd-916f-7bc3bf31f1a7 0187-5115 HUMAN PRESCRIPTION DRUG Ertaczo Sertaconazole Nitrate CREAM TOPICAL 20031210 NDA NDA021385 Valeant Pharmaceuticals North America LLC SERTACONAZOLE NITRATE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0187-5140_2772328d-2eb1-429e-b6ab-681e09f91232 0187-5140 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 19970207 NDA NDA020475 Valeant Pharmaceuticals North America LLC TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0187-5144_2772328d-2eb1-429e-b6ab-681e09f91232 0187-5144 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 20020510 NDA NDA020475 Valeant Pharmaceuticals North America LLC TRETINOIN .4 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0187-5148_2772328d-2eb1-429e-b6ab-681e09f91232 0187-5148 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 20140128 NDA NDA020475 Valeant Pharmaceuticals North America LLC TRETINOIN .8 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0187-5150_3f60649e-7457-4ad3-b5b2-9b6a64b38b8a 0187-5150 HUMAN PRESCRIPTION DRUG Renova Tretinoin CREAM TOPICAL 20000831 NDA NDA021108 Valeant Pharmaceuticals North America LLC TRETINOIN .2 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0187-5160_da23de99-754f-4c25-b122-e1544bb60f61 0187-5160 HUMAN PRESCRIPTION DRUG Retin-A Tretinoin CREAM TOPICAL 19881030 NDA NDA019049 Valeant Pharmaceuticals North America LLC TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0187-5162_da23de99-754f-4c25-b122-e1544bb60f61 0187-5162 HUMAN PRESCRIPTION DRUG Retin-A Tretinoin CREAM TOPICAL 19740730 NDA NDA017522 Valeant Pharmaceuticals North America LLC TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0187-5164_da23de99-754f-4c25-b122-e1544bb60f61 0187-5164 HUMAN PRESCRIPTION DRUG Retin-A Tretinoin CREAM TOPICAL 19730430 NDA NDA017340 Valeant Pharmaceuticals North America LLC TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0187-5170_da23de99-754f-4c25-b122-e1544bb60f61 0187-5170 HUMAN PRESCRIPTION DRUG Retin-A Tretinoin GEL TOPICAL 19750730 NDA NDA017579 Valeant Pharmaceuticals North America LLC TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0187-5172_da23de99-754f-4c25-b122-e1544bb60f61 0187-5172 HUMAN PRESCRIPTION DRUG Retin-A Tretinoin GEL TOPICAL 19790730 NDA NDA017955 Valeant Pharmaceuticals North America LLC TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0187-5180_9793245c-c3e0-4351-a2ab-b54b46aecb43 0187-5180 HUMAN PRESCRIPTION DRUG Penlac ciclopirox SOLUTION TOPICAL 20130501 NDA NDA021022 Valeant Pharmaceuticals North America LLC CICLOPIROX 80 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 0187-5182_ccc7985a-da29-475f-8a53-0f76ba20b86d 0187-5182 HUMAN PRESCRIPTION DRUG Dermatop prednicarbate CREAM TOPICAL 19931029 NDA NDA020279 Valeant Pharmaceuticals North America LLC PREDNICARBATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0187-5183_11c5d43d-7daf-4450-9341-2fdc4caa5f6e 0187-5183 HUMAN PRESCRIPTION DRUG Dermatop prednicarbate OINTMENT TOPICAL 20140623 NDA NDA019568 Valeant Pharmaceuticals North America LLC PREDNICARBATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0187-5190_c5d98f4d-09c3-4242-b39c-4f6fabaef07c 0187-5190 HUMAN PRESCRIPTION DRUG Benzaclin Clindamycin phosphate and benzoyl peroxide GEL TOPICAL 20001221 NDA NDA050756 Valeant Pharmaceuticals North America LLC BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 50; 10 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0187-5198_0c16b9dc-9474-4884-a2ac-45cac65e95d6 0187-5198 HUMAN PRESCRIPTION DRUG Klaron sulfacetamide sodium LOTION TOPICAL 19961223 NDA NDA019931 Valeant Pharmaceuticals North America LLC SULFACETAMIDE SODIUM 10 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0187-5200_73ab6a7d-6643-490a-bee8-428397a616e7 0187-5200 HUMAN PRESCRIPTION DRUG Carac fluorouracil CREAM TOPICAL 20130628 NDA NDA020985 Valeant Pharmaceuticals North America LLC FLUOROURACIL 5 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0187-5202_c217c0e9-2862-42e2-8b24-6dae6d17e064 0187-5202 HUMAN PRESCRIPTION DRUG Noritate metronidazole CREAM TOPICAL 20130809 NDA NDA020743 Valeant Pharmaceuticals North America LLC METRONIDAZOLE 10 mg/60g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0187-5205_db47c1d6-b411-4dc3-96c1-ce2c356fe435 0187-5205 HUMAN PRESCRIPTION DRUG Benzamycin erythromycin and benzoyl peroxide KIT 19841026 NDA NDA050557 Valeant Pharmaceuticals North America LLC 0187-5207_0c76cd91-46b5-4e84-a5d9-e86b0f1e3bd9 0187-5207 HUMAN PRESCRIPTION DRUG Benzamycin Pak erythromycin and benzoyl peroxide GEL TOPICAL 20001127 NDA NDA050769 Valeant Pharmaceuticals North America LLC BENZOYL PEROXIDE; ERYTHROMYCIN 50; 30 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0187-5268_576e70e9-3899-45b2-bb89-cf5267b301bb 0187-5268 HUMAN PRESCRIPTION DRUG Nephrocaps Ascorbic Acid, Folic Acid, Niacin, Thiamine, Riboflavin, Pyridoxine, Cyanocobalamin, Pantothenic Acid, Biotin CAPSULE, LIQUID FILLED ORAL 20120618 UNAPPROVED DRUG OTHER Valeant Pharmaceuticals North America LLC ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; THIAMINE 100; 150; 6; 1; 20; 5; 10; 1.7; 1.5 mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 0187-5269_4627bdf8-a32d-4376-b018-f5944dc9d4a4 0187-5269 HUMAN PRESCRIPTION DRUG Nephrocaps-QT Cholecalciferol, Ascorbic Acid, Folic Acid, Thiamin, Riboflavin, Niacin, Pantothenic Acid, Pyridoxine HCl, Biotin, Cyanocobalamin TABLET, ORALLY DISINTEGRATING ORAL 20120608 UNAPPROVED DRUG OTHER Valeant Pharmaceuticals North America LLC ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE 100; 150; 1750; 6; 1; 20; 5; 10; 1.7; 1.5 mg/1; ug/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 0187-5400_922d4d24-c530-11e1-9b21-0800200c9a66 0187-5400 HUMAN PRESCRIPTION DRUG JUBLIA efinaconazole SOLUTION TOPICAL 20140606 NDA NDA203567 Valeant Pharmaceuticals North America LLC EFINACONAZOLE 100 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0187-5465_c6863713-74a5-48a1-8715-27f201eb3c79 0187-5465 HUMAN OTC DRUG Caladryl Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride LOTION TOPICAL 20130816 OTC MONOGRAPH FINAL part347 Valeant Pharmaceuticals North America LLC FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 1.36; 10; 78.65 mg/mL; mg/mL; mg/mL 0187-5466_9653b0cf-f0f6-4749-b614-752c12c1d335 0187-5466 HUMAN OTC DRUG Caladryl Clear PRAMOXINE HYDROCHLORIDE and ZINC ACETATE LOTION TOPICAL 20130816 OTC MONOGRAPH FINAL part347 Valeant Pharmaceuticals North America LLC PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL 0187-5470_dc017cd1-1b52-486b-b6e3-9c7192b3a33a 0187-5470 HUMAN OTC DRUG Ambi Even and Clear Exfoliating Wash Salicylic Acid CREAM TOPICAL 20141110 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC SALICYLIC ACID 5 mg/g 0187-5471_dc017cd1-1b52-486b-b6e3-9c7192b3a33a 0187-5471 HUMAN OTC DRUG Ambi Even and Clear Exfoliating Wash Salicylic Acid CREAM TOPICAL 20140715 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC SALICYLIC ACID 5 mg/g 0187-5475_36362fb5-6e3c-4ff5-a305-3434392578f9 0187-5475 HUMAN OTC DRUG Ambi Even and Clear Daily Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130711 OTC MONOGRAPH NOT FINAL part352 Valeant Pharmaceuticals North America LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 0187-5478_25f7658e-96c1-4dc6-ae33-fe020027d3ac 0187-5478 HUMAN OTC DRUG Ambi Essentials Avobenzone, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20130820 OTC MONOGRAPH NOT FINAL part352 Valeant Pharmaceuticals North America LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 50; 17; 30 mg/59mL; mg/59mL; mg/59mL; mg/59mL 0187-5479_2e335de0-1593-4abe-94f0-26b492c83fb6 0187-5479 HUMAN OTC DRUG AMBI Fade Normal Skin Hydroquinone and Octinoxate CREAM TOPICAL 20140204 OTC MONOGRAPH NOT FINAL part358A Valeant Pharmaceuticals North America LLC HYDROQUINONE; OCTINOXATE 20; 20 mg/g; mg/g 0187-5485_8b233184-4c65-4a7f-a496-5050da8cb3b0 0187-5485 HUMAN OTC DRUG Ambi Acne Spot Treatment Benzoyl Peroxide CREAM TOPICAL 20140117 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC BENZOYL PEROXIDE 1.4 g/28g 0187-5500_c581e84f-1361-4343-a962-3634949aef36 0187-5500 HUMAN OTC DRUG Purpose Octinoxate, Octisalate and Oxybenzone LOTION TOPICAL 20131007 OTC MONOGRAPH NOT FINAL part352 Valeant Pharmaceuticals North America LLC OCTINOXATE; OCTISALATE; OXYBENZONE 76; 50; 30 mg/mL; mg/mL; mg/mL 0187-5518_f3f31285-4dde-4708-b715-6da36a4f2a14 0187-5518 HUMAN OTC DRUG Cortaid Intensive Therapy Cooling Hydrocortisone SPRAY TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part348 Valeant Pharmaceuticals North America LLC HYDROCORTISONE 10 g/mL 0187-5519_94c6a460-01b9-4c18-ac16-887e10823271 0187-5519 HUMAN OTC DRUG Cortaid 12-Hour Advanced Anti-Itch Hydrocortisone CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part348 Valeant Pharmaceuticals North America LLC HYDROCORTISONE 1 g/100g 0187-5520_78e59b20-42da-44dc-a1ac-5ac19596babc 0187-5520 HUMAN OTC DRUG Cortaid Maximum Strength Hydrocortisone CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part348 Valeant Pharmaceuticals North America LLC HYDROCORTISONE 1 g/100g 0187-5521_78e59b20-42da-44dc-a1ac-5ac19596babc 0187-5521 HUMAN OTC DRUG Cortaid Maximum Strength Hydrocortisone CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part348 Valeant Pharmaceuticals North America LLC HYDROCORTISONE 1 g/100g 0187-5525_d35b4697-3f3b-4aa1-b5d9-153993e83811 0187-5525 HUMAN PRESCRIPTION DRUG Targretin bexarotene GEL TOPICAL 20000628 NDA NDA021056 Valeant Pharmaceuticals North America LLC BEXAROTENE 1 g/100g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0187-5526_1d056725-0576-4338-8089-6336e768ccdc 0187-5526 HUMAN PRESCRIPTION DRUG Targretin bexarotene CAPSULE, LIQUID FILLED ORAL 19991229 NDA NDA021055 Valeant Pharmaceuticals North America LLC BEXAROTENE 75 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 0187-5600_952f4c80-50b1-4308-9ee6-311ffefb13df 0187-5600 HUMAN PRESCRIPTION DRUG Visudyne verteporfin for injection INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20000412 NDA NDA021119 Valeant Pharmaceuticals North America LLC VERTEPORFIN 15 mg/1 Photoabsorption [MoA],Photoenhancer [EPC],Photosensitizing Activity [PE] 0187-5810_6494d2d9-0ce4-4126-b1c7-49684395942b 0187-5810 HUMAN PRESCRIPTION DRUG Aplenzin bupropion hydrobromide TABLET, EXTENDED RELEASE ORAL 20090330 NDA NDA022108 Valeant Pharmaceuticals North America LLC BUPROPION HYDROBROMIDE 174 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0187-5811_6494d2d9-0ce4-4126-b1c7-49684395942b 0187-5811 HUMAN PRESCRIPTION DRUG Aplenzin bupropion hydrobromide TABLET, EXTENDED RELEASE ORAL 20090330 NDA NDA022108 Valeant Pharmaceuticals North America LLC BUPROPION HYDROBROMIDE 348 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0187-5812_6494d2d9-0ce4-4126-b1c7-49684395942b 0187-5812 HUMAN PRESCRIPTION DRUG Aplenzin bupropion hydrobromide TABLET, EXTENDED RELEASE ORAL 20090330 NDA NDA022108 Valeant Pharmaceuticals North America LLC BUPROPION HYDROBROMIDE 522 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0206-2100_e05e7a51-bb0d-4765-9a56-0f6ae9d19f9a 0206-2100 HUMAN PRESCRIPTION DRUG Zosyn piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20131218 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-2404_0fd5dba3-86b9-401d-bc28-d525f7a0e7bc 0206-2404 HUMAN PRESCRIPTION DRUG Zosyn piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19931101 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-2405_0fd5dba3-86b9-401d-bc28-d525f7a0e7bc 0206-2405 HUMAN PRESCRIPTION DRUG Zosyn piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19931101 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-2408_0fd5dba3-86b9-401d-bc28-d525f7a0e7bc 0206-2408 HUMAN PRESCRIPTION DRUG Zosyn piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19931101 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-2409_0fd5dba3-86b9-401d-bc28-d525f7a0e7bc 0206-2409 HUMAN PRESCRIPTION DRUG Zosyn in Galaxy Containers PIPERACILLIN SODIUM and TAZOBACTAM SODIUM INJECTION, SOLUTION INTRAVENOUS 19980301 NDA NDA050750 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; 250 g/50mL; mg/50mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-2411_0fd5dba3-86b9-401d-bc28-d525f7a0e7bc 0206-2411 HUMAN PRESCRIPTION DRUG Zosyn in Galaxy Containers PIPERACILLIN SODIUM and TAZOBACTAM SODIUM INJECTION, SOLUTION INTRAVENOUS 19980301 NDA NDA050750 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; 375 g/50mL; mg/50mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-2413_0fd5dba3-86b9-401d-bc28-d525f7a0e7bc 0206-2413 HUMAN PRESCRIPTION DRUG Zosyn in Galaxy Containers PIPERACILLIN SODIUM and TAZOBACTAM SODIUM INJECTION, SOLUTION INTRAVENOUS 19980301 NDA NDA050750 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; 500 g/100mL; mg/100mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-2416_0fd5dba3-86b9-401d-bc28-d525f7a0e7bc 0206-2416 HUMAN PRESCRIPTION DRUG Zosyn piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19931101 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-2501_1c1bdf53-9679-41d7-b40d-dd7719240a20 0206-2501 HUMAN PRESCRIPTION DRUG Zosyn tazobactam sodium and piperacillin sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130601 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-3100_e05e7a51-bb0d-4765-9a56-0f6ae9d19f9a 0206-3100 HUMAN PRESCRIPTION DRUG Zosyn piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20131218 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-3501_1c1bdf53-9679-41d7-b40d-dd7719240a20 0206-3501 HUMAN PRESCRIPTION DRUG Zosyn tazobactam sodium and piperacillin sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130601 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-4100_e05e7a51-bb0d-4765-9a56-0f6ae9d19f9a 0206-4100 HUMAN PRESCRIPTION DRUG Zosyn piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20131218 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-4501_1c1bdf53-9679-41d7-b40d-dd7719240a20 0206-4501 HUMAN PRESCRIPTION DRUG Zosyn tazobactam sodium and piperacillin sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130601 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-5501_1c1bdf53-9679-41d7-b40d-dd7719240a20 0206-5501 HUMAN PRESCRIPTION DRUG Zosyn Pharmacy Bulk Package tazobactam sodium and piperacillin sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130601 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 36; 4.5 g/180mL; g/180mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-8852_48dd60dd-ffcd-4d34-9935-d38fea37f3af 0206-8852 HUMAN PRESCRIPTION DRUG Zosyn piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19931101 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-8854_48dd60dd-ffcd-4d34-9935-d38fea37f3af 0206-8854 HUMAN PRESCRIPTION DRUG Zosyn piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19931101 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-8855_48dd60dd-ffcd-4d34-9935-d38fea37f3af 0206-8855 HUMAN PRESCRIPTION DRUG Zosyn piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19931101 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-8859_48dd60dd-ffcd-4d34-9935-d38fea37f3af 0206-8859 HUMAN PRESCRIPTION DRUG Zosyn Pharmacy Bulk Package PIPERACILLIN SODIUM and TAZOBACTAM SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19931101 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 36; 4.5 g/180mL; g/180mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-8860_48dd60dd-ffcd-4d34-9935-d38fea37f3af 0206-8860 HUMAN PRESCRIPTION DRUG Zosyn in Galaxy Containers TAZOBACTAM SODIUM and PIPERACILLIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19980301 NDA NDA050750 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; 250 g/50mL; mg/50mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-8861_48dd60dd-ffcd-4d34-9935-d38fea37f3af 0206-8861 HUMAN PRESCRIPTION DRUG Zosyn in Galaxy Containers TAZOBACTAM SODIUM and PIPERACILLIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19980301 NDA NDA050750 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; 375 g/50mL; mg/50mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0206-8862_48dd60dd-ffcd-4d34-9935-d38fea37f3af 0206-8862 HUMAN PRESCRIPTION DRUG Zosyn in Galaxy Containers TAZOBACTAM SODIUM and PIPERACILLIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19980301 NDA NDA050750 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; 500 g/100mL; mg/100mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0219-0203_22488c18-7761-40ea-8905-297af63f9a4b 0219-0203 HUMAN OTC DRUG Humphreys Bendito Alcoholado menthol LIQUID TOPICAL 19720111 OTC MONOGRAPH NOT FINAL part348 Humphreys Pharmacal, Incorporated MENTHOL 12.5 mg/mL 0219-2020_452b8063-1649-4f06-9b6e-99881ba74453 0219-2020 HUMAN OTC DRUG Humphreys Alcoholado Maravilla ALCOHOL LIQUID TOPICAL 19720111 OTC MONOGRAPH NOT FINAL part333A Humphreys Pharmacal, Incorporated ALCOHOL 70 mL/100mL 0219-3103_a9c55662-9362-48f9-a07f-62d865301b7e 0219-3103 HUMAN OTC DRUG Humphreys Baby Teething Relief Very Cherry matricaria recutita, arabica coffee bean, tribasic calcium phosphate PELLET ORAL 20120101 UNAPPROVED HOMEOPATHIC Humphreys Pharmacal, Incorporated ARABICA COFFEE BEAN; MATRICARIA RECUTITA; TRIBASIC CALCIUM PHOSPHATE 3; 3; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1 0219-4103_5170ed26-40b2-47df-b7e3-8f0976abef2f 0219-4103 HUMAN OTC DRUG Humphreys Baby Teething Relief Cherry Swift Strips matricaria recutita, arabica coffee bean, tribasic calcium phosphate FILM, SOLUBLE ORAL 20120101 UNAPPROVED HOMEOPATHIC Humphreys Pharmacal, Incorporated ARABICA COFFEE BEAN; MATRICARIA RECUTITA; TRIBASIC CALCIUM PHOSPHATE 3; 3; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1 0219-6103_1c039fc9-44a5-4788-a5a3-0e9d9e7d5e7e 0219-6103 HUMAN OTC DRUG Humphreys Baby Teething Relief Original matricaria recutita, arabica coffee bean, tribasic calcium phosphate PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Humphreys Pharmacal, Incorporated ARABICA COFFEE BEAN; MATRICARIA RECUTITA; TRIBASIC CALCIUM PHOSPHATE 3; 3; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1 0220-0508_631842d2-a09b-4d26-883c-4787c0f3c963 0220-0508 HUMAN OTC DRUG Arnica ARNICA MONTANA PELLET ORAL 20090501 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA 30 [hp_C]/1 0220-1104_d22aca8a-7845-483f-bc90-0a6163d8f5a5 0220-1104 HUMAN OTC DRUG Calendula CALENDULA OFFICINALIS FLOWERING TOP OINTMENT TOPICAL 19880717 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g 0220-1105_8a8e612b-39ab-4d56-9b53-06fef06ee206 0220-1105 HUMAN OTC DRUG Calendula CALENDULA OFFICINALIS FLOWERING TOP GEL TOPICAL 19930930 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g 0220-1106_75371023-25eb-446f-87a4-b9139a91ac4f 0220-1106 HUMAN OTC DRUG Calendula CALENDULA OFFICINALIS FLOWERING TOP LOTION TOPICAL 19930930 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/mL 0220-1108_084a2c1e-36de-46af-9738-25583ed637da 0220-1108 HUMAN OTC DRUG Calendula CALENDULA OFFICINALIS FLOWERING TOP GEL TOPICAL 19900413 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g 0220-1109_f93b166c-3f68-42a7-ac09-f5283deaf729 0220-1109 HUMAN OTC DRUG Calendula CALENDULA OFFICINALIS FLOWERING TOP CREAM TOPICAL 20060321 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g 0220-3681_fb9a890d-5973-46c7-a68b-2e04368b2e99 0220-3681 HUMAN OTC DRUG Nux Vomica STRYCHNOS NUX-VOMICA SEED PELLET ORAL 20120101 UNAPPROVED HOMEOPATHIC Laboratoires Boiron STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/1 0220-9000_3f1c465c-5769-451b-89c4-58ff588bdbab 0220-9000 HUMAN OTC DRUG Arnicare ARNICA MONTANA GEL TOPICAL 20070109 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA 1 [hp_X]/g 0220-9004_d3da7576-e056-4032-aeb7-65e64cbbc3cd 0220-9004 HUMAN OTC DRUG Acidil PICEA MARIANA RESIN, ACTIVATED CHARCOAL, STRYCHNOS NUX-VOMICA SEED, ROBINIA PSEUDOACACIA BARK TABLET ORAL 19970805 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ACTIVATED CHARCOAL; PICEA MARIANA RESIN; ROBINIA PSEUDOACACIA BARK; STRYCHNOS NUX-VOMICA SEED 4; 4; 4; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9013_d424cd47-1039-4c61-b6ad-061549734887 0220-9013 HUMAN OTC DRUG Avenoc HORSE CHESTNUT, COLLINSONIA CANADENSIS ROOT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK OINTMENT TOPICAL 20070602 UNAPPROVED HOMEOPATHIC Laboratoires Boiron COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g 0220-9015_d83443ab-ce98-4010-bc0e-c6bd097fd100 0220-9015 HUMAN OTC DRUG Avenoc HORSE CHESTNUT, COLLINSONIA CANADENSIS ROOT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK SUPPOSITORY RECTAL 20030224 UNAPPROVED HOMEOPATHIC Laboratoires Boiron COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 0220-9021_eda68053-2c56-45de-bce3-8bb3308feb3c 0220-9021 HUMAN OTC DRUG ARNICARE ARNICA MONTANA CREAM TOPICAL 20070315 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA 1 [hp_X]/g 0220-9023_eca66347-0ff7-4104-907f-3ebe44b96c11 0220-9023 HUMAN OTC DRUG Arnicare ARNICA MONTANA OINTMENT CUTANEOUS 20070602 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA 1 [hp_X]/g 0220-9032_58992243-5a18-4397-968d-55b4a5ab753c 0220-9032 HUMAN OTC DRUG Chestal ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, PROTORTONIA CACTI, DROSERA ROTUNDIFOLIA, IPECAC, PULSATILLA VULGARIS, RUMEX CRISPUS ROOT, PONGIA OFFICINALIS SKELETON, ROASTED, LOBARIA PULMONARIA SYRUP ORAL 19930201 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA FLOWERING TOP; IPECAC; LOBARIA PULMONARIA; PROTORTONIA CACTI; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 3; 3; 3; 3; 3; 6; 6; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 0220-9033_e471b429-38b6-4c8f-b34c-9fdc4e6e9560 0220-9033 HUMAN OTC DRUG Chestal for Children ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, PROTORTONIA CACTI, DROSERA ROTUNDIFOLIA, IPECAC, PULSATILLA VULGARIS, RUMEX CRISPUS ROOT, PONGIA OFFICINALIS SKELETON, ROASTED, LOBARIA PULMONARIA SYRUP ORAL 19960801 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA FLOWERING TOP; IPECAC; LOBARIA PULMONARIA; PROTORTONIA CACTI; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 3; 3; 3; 3; 3; 6; 6; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9042_b24315df-647f-452b-8c5a-10106d160a29 0220-9042 HUMAN OTC DRUG Arnicare Value Pack ARNICA MONTANA KIT 20081101 UNAPPROVED HOMEOPATHIC Laboratoires Boiron 0220-9044_9fe31d95-9dfd-4ce5-8908-62f8d2d3de15 0220-9044 HUMAN OTC DRUG Arnicare Arthritis ARNICA MONTANA, BENZOIC ACID, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, SOLANUM DULCAMARA TOP, POTASSIUM IODIDE, PULSATILLA VULGARIS, RHODODENDRON AUREUM LEAF, TOXICODENDRON PUBESCENS LEAF TABLET ORAL 20071123 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA; BENZOIC ACID; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; POTASSIUM IODIDE; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; SOLANUM DULCAMARA TOP; TOXICODENDRON PUBESCENS LEAF 3; 6; 6; 12; 12; 3; 12; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9045_df15b79a-6b74-4f40-9e03-96d95a4e0d28 0220-9045 HUMAN OTC DRUG Cocyntal ACTIVATED CHARCOAL, CITRULLUS COLOCYNTHIS FRUIT, COPPER LIQUID ORAL 20110715 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ACTIVATED CHARCOAL; CITRULLUS COLOCYNTHIS FRUIT; COPPER 5; 9; 5 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 0220-9046_c7e4e5c1-d81a-44e1-8903-22fb32b95d41 0220-9046 HUMAN OTC DRUG Arnicare Trauma ARNICA MONTANA, BELLIS PERENNIS, BELLIS PERENNIS PELLET ORAL 20091201 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA; BELLIS PERENNIS; LEDUM PALUSTRE TWIG 9; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9047_16e53417-f0f2-4133-a321-ef5b7d4d8698 0220-9047 HUMAN OTC DRUG Arnica Value Pack ARNICA MONTANA KIT 20081101 UNAPPROVED HOMEOPATHIC Laboratoires Boiron 0220-9048_e1e71878-e540-4eb5-866a-dfa9d0a41a65 0220-9048 HUMAN OTC DRUG Coldcalm ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION TABLET ORAL 19950101 UNAPPROVED HOMEOPATHIC Laboratoires Boiron APIS MELLIFERA; ATROPA BELLADONNA; DICHROMATE ION; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ONION; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED 6; 6; 6; 3; 6; 3; 6; 6; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9049_17187d97-5dc5-4ecf-adec-3957309ed9d2 0220-9049 HUMAN OTC DRUG Children Coldcalm ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULG PELLET ORAL 20080908 UNAPPROVED HOMEOPATHIC Laboratoires Boiron APIS MELLIFERA; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ONION; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED 5; 6; 3; 6; 3; 6; 6; 6; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9050_a79b0a7b-68f6-4383-a6b3-cb30d3a8c3bf 0220-9050 HUMAN OTC DRUG Arnicare Procedure Recovery ARNICA MONTANA KIT 20071101 UNAPPROVED HOMEOPATHIC Laboratoires Boiron 0220-9054_374bedab-a86d-421f-81fd-c66c4e001e48 0220-9054 HUMAN OTC DRUG Camilia MATRICARIA RECUTITA, RHUBARB, PHYTOLACCA AMERICANA ROOT LIQUID ORAL 20101201 UNAPPROVED HOMEOPATHIC Laboratoires Boiron MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT; RHUBARB 9; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9054_670b8a14-62cb-4451-8ac4-9fa707c8ef7e 0220-9054 HUMAN OTC DRUG Camilia MATRICARIA RECUTITA, RHUBARB, PHYTOLACCA AMERICANA ROOT LIQUID ORAL 20110715 UNAPPROVED HOMEOPATHIC Laboratoires Boiron MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT; RHUBARB 9; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9054_77b76601-cbab-4d69-a529-52439485525f 0220-9054 HUMAN OTC DRUG Camilia MATRICARIA RECUTITA, RHUBARB, PHYTOLACCA AMERICANA ROOT LIQUID ORAL 20140101 UNAPPROVED HOMEOPATHIC Laboratoires Boiron MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT; RHUBARB 9; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9059_6ddfe8ef-bee6-4dc9-9de9-af0eba46c248 0220-9059 HUMAN OTC DRUG Arnicare Arnica ARNICA MONTANA TABLET ORAL 20110711 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA 9 [hp_C]/1 0220-9061_f18d4bd4-a09c-4d47-82fc-6183669fe7e3 0220-9061 HUMAN OTC DRUG Childrens Sabadil ONION, AMBROSIA ARTEMISIIFOLIA, HISTAMINE DIHYDROCHLORIDE, SCHOENOCAULON OFFICINALE SEED, EUPHRASIA STRICTA, SOLIDAGO VIRGAUREA FLOWERING TOP PELLET ORAL 20100119 UNAPPROVED HOMEOPATHIC Laboratoires Boiron AMBROSIA ARTEMISIIFOLIA; EUPHRASIA STRICTA; HISTAMINE DIHYDROCHLORIDE; ONION; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP 5; 5; 9; 5; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9062_5a6ec4c5-8285-4385-b810-fe68850dfb97 0220-9062 HUMAN OTC DRUG Chestal Child Berry ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, PROTORTONIA CACTI, DROSERA ROTUNDIFOLIA, IPECAC, PULSATILLA VULGARIS, RUMEX CRISPUS ROOT, PONGIA OFFICINALIS SKELETON, ROASTED, LOBARIA PULMONARIA SYRUP ORAL 20110601 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; IPECAC; LOBARIA PULMONARIA; PROTORTONIA CACTI; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 3; 3; 3; 3; 3; 6; 6; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9063_79619fb5-88e1-4139-8e99-5a5ce147b09e 0220-9063 HUMAN OTC DRUG Chestal Berry ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, PROTORTONIA CACTI, DROSERA ROTUNDIFOLIA, IPECAC, PULSATILLA VULGARIS, RUMEX CRISPUS ROOT, PONGIA OFFICINALIS SKELETON, ROASTED, LOBARIA PULMONARIA SYRUP ORAL 20110601 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; IPECAC; LOBARIA PULMONARIA; PROTORTONIA CACTI; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 3; 3; 3; 3; 3; 6; 6; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9067_75317712-ddb3-48c3-a6a7-8cf358fe94c7 0220-9067 HUMAN OTC DRUG Chestal Cough and Cold SOLANUM DULCAMARA TOP, FERRUM PHOSPHORICUM, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED SYRUP ORAL 20130601 UNAPPROVED HOMEOPATHIC Laboratoires Boiron FERRUM PHOSPHORICUM; GOLDENSEAL; POTASSIUM DICHROMATE; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED 9; 9; 9; 5; 9 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 0220-9068_dd72705e-9946-4d68-8707-c411a24ff920 0220-9068 HUMAN OTC DRUG Chestal Childrens Cough and Cold SOLANUM DULCAMARA TOP, FERRUM PHOSPHORICUM, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED SYRUP ORAL 20130601 UNAPPROVED HOMEOPATHIC Laboratoires Boiron FERRUM PHOSPHORICUM; GOLDENSEAL; POTASSIUM DICHROMATE; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED 9; 9; 9; 5; 9 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 0220-9078_e4a0c6b2-8335-4517-9436-ece5f61456cb 0220-9078 HUMAN OTC DRUG Cyclease Cramp BLACK COHOSH, CITRULLUS COLOCYNTHIS FRUIT PULP, ESIUM PHOSPHATE, DIBASIC TRIHYDRATE TABLET ORAL 19920708 UNAPPROVED HOMEOPATHIC Laboratoires Boiron BLACK COHOSH; CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9081_e3928762-73d5-4ab7-a705-a292f479f072 0220-9081 HUMAN OTC DRUG Cyclease PMS ESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICE TABLET ORAL 20020812 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ESTRONE; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE 15; 12; 12 [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9131_fa7878f8-c5ec-4f1f-94ea-1c42a1165567 0220-9131 HUMAN OTC DRUG Flu Relief CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE PELLET ORAL 20100715 UNAPPROVED HOMEOPATHIC Labratoires Boiron CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/g 0220-9134_f9e6201d-b1a0-4efa-93bc-66f88833f08d 0220-9134 HUMAN OTC DRUG Gasalia ACTIVATED CHARCOAL, LYCOPODIUM CLAVATUM SPORE, NUTMEG, DAIKON TABLET ORAL 19970805 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ACTIVATED CHARCOAL; DAIKON; LYCOPODIUM CLAVATUM SPORE; NUTMEG 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9277_c260a5c0-265e-476c-bfa0-ab8a7f79fccf 0220-9277 HUMAN OTC DRUG Optique 1 JACOBAEA MARITIMA, EUPHRASIA STRICTA, CALENDULA OFFICINALIS FLOWERING TOP, POTASSIUM CHLORIDE, SILICON DIOXIDE, MAGNESIUM CARBONATE LIQUID ORAL 19950717 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; EUPHRASIA STRICTA; JACOBAEA MARITIMA; MAGNESIUM CARBONATE; POTASSIUM CHLORIDE; SILICON DIOXIDE 10; 4; 9; 6; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 0220-9280_a6d3fac7-55a0-485a-91a1-07735c1931c8 0220-9280 HUMAN OTC DRUG Oscillococcinum CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE PELLET ORAL 19980801 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/1 0220-9281_900dbef5-71c0-4134-af2a-c1ab90ffbda4 0220-9281 HUMAN OTC DRUG Children Oscillococcinum CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE PELLET ORAL 20080901 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/1 0220-9313_7e740dea-91bd-4f42-97f0-e167e5110b42 0220-9313 HUMAN OTC DRUG Quietude HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM TABLET ORAL 19910613 UNAPPROVED HOMEOPATHIC Laboratoires Boiron DATURA STRAMONIUM; HYOSCYAMUS NIGER; NUTMEG; PASSIFLORA INCARNATA TOP 6; 3; 4; 3 [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1 0220-9314_c1c69dd5-260c-4220-83d4-79e11fe4512f 0220-9314 HUMAN OTC DRUG Quietude HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM TABLET ORAL 20131001 UNAPPROVED HOMEOPATHIC Laboratoires Boiron DATURA STRAMONIUM; HYOSCYAMUS NIGER; NUTMEG; PASSIFLORA INCARNATA TOP 6; 3; 4; 3 [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1 0220-9321_004e3089-74de-481a-abdb-204db7b0a1b6 0220-9321 HUMAN OTC DRUG Roxalia ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED TABLET ORAL 20131001 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARISAEMA TRIPHYLLUM ROOT; ARNICA MONTANA; BELLADONNA LEAF; BROMINE; BRYONIA ALBA ROOT; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED 3; 3; 3; 3; 3; 4; 3; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9322_6d6aa631-eb45-4f87-8562-b537762aee9f 0220-9322 HUMAN OTC DRUG Roxalia ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS, PHYTOLACCA AMERICANA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED TABLET ORAL 19970901 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARISAEMA TRIPHYLLUM ROOT; ARNICA MONTANA; BELLADONNA LEAF; BROMINE; BRYONIA ALBA ROOT; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED 3; 3; 3; 3; 3; 3; 3; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9324_01f6dce2-f7a2-40f4-8b19-a2b9ce201a4e 0220-9324 HUMAN OTC DRUG Sabadil ONION, AMBROSIA ARTEMISIIFOLIA, HISTAMINE DIHYDROCHLORIDE, EUPHRASIA STRICTA, SCHOENOCAULON OFFICINALE SEED, SOLIDAGO VIRGAUREA FLOWERING TOP TABLET ORAL 19970901 UNAPPROVED HOMEOPATHIC Laboratoires Boiron AMBROSIA ARTEMISIIFOLIA; EUPHRASIA STRICTA; HISTAMINE DIHYDROCHLORIDE; ONION; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP 5; 5; 9; 5; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9332_c8ddc810-1b2e-4c17-b4d1-50b823977eb0 0220-9332 HUMAN OTC DRUG Sedalia ACONITUM NAPELLUS, BELLADONNA LEAF, CALENDULA OFFICINALIS FLOWERING TOP, CHELIDONIUM MAJUS, ABRUS PRECATORIUS SEED, VIBURNUM OPULUS ROOT TABLET ORAL 19970705 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ABRUS PRECATORIUS SEED; ACONITUM NAPELLUS; BELLADONNA LEAF; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; VIBURNUM OPULUS BARK 6; 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9341_127eaf4d-2700-46d6-9bf8-1910e18b6905 0220-9341 HUMAN OTC DRUG Sinusalia BELLADONNA LEAF, SANGUINARIA CANADENSIS ROOT, SPIGELIA TABLET ORAL 20110401 UNAPPROVED HOMEOPATHIC Laboratoires Boiron BELLADONNA LEAF; SANGUINARIA CANADENSIS ROOT; SPIGELIA MARILANDICA ROOT 3; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9342_2697f467-cfd3-490c-8111-777662795324 0220-9342 HUMAN OTC DRUG Sinusalia BELLADONNA LEAF, SANGUINARIA CANADENSIS ROOT, SPIGELIA TABLET ORAL 19970901 UNAPPROVED HOMEOPATHIC Labratoires Boiron BELLADONNA LEAF; SANGUINARIA CANADENSIS ROOT; SPIGELIA 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 0220-9343_6572278f-c06a-44c7-bb44-a2ab5c9dd9e7 0220-9343 HUMAN OTC DRUG Sinusalia ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA PELLET ORAL 20080908 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ATROPA BELLADONNA; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 0220-9346_21aa2e59-06b6-4489-9101-47fabb41029c 0220-9346 HUMAN OTC DRUG Sinusalia ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA PELLET ORAL 20111201 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ATROPA BELLADONNA; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA 3; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1 0220-9352_95c981e1-a561-4f4f-b593-d9efc8662cd9 0220-9352 HUMAN OTC DRUG Sportenine ARNICA MONTANA, LACTIC ACID, L-, ZINC OXIDE TABLET ORAL 19870221 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA; LACTIC ACID, L-; ZINC OXIDE 9; 6; 6 [hp_C]/1; [hp_X]/1; [hp_X]/1 0220-9374_2292bb19-0906-4b11-9432-b6f3439ab730 0220-9374 HUMAN OTC DRUG Yeastaway SODIUM BORATE, CALENDULA OFFICINALIS FLOWERING TOP, CANDIDA ALBICANS, GOLDENSEAL SUPPOSITORY VAGINAL 19920708 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CALENDULA OFFICINALIS FLOWERING TOP; CANDIDA ALBICANS; GOLDENSEAL; SODIUM BORATE 1; 30; 1; 14 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 0224-0500_596386cb-29ad-4502-b317-3aa11b59fd5c 0224-0500 HUMAN OTC DRUG KONSYL Daily Therapy Fiber CALCIUM POLYCARBOPHIL TABLET ORAL 20120312 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. CALCIUM POLYCARBOPHIL 625 mg/1 0224-1801_11266362-88c2-4e97-8ae0-21b4794ec4f5 0224-1801 HUMAN OTC DRUG KONSYL Original Formula Psyllium Fiber PSYLLIUM HUSK GRANULE ORAL 20110331 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 6 g/6g 0224-1822_24b6c19b-b959-4422-9183-35f0441c5d16 0224-1822 HUMAN OTC DRUG Konsyl Naturally Sweetened Psyllium Fiber PSYLLIUM HUSK GRANULE ORAL 20110331 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 3.4 g/6.5g 0224-1841_353405a6-de3c-4052-8939-f7c195741d87 0224-1841 HUMAN OTC DRUG KONSYL Orange Flavor Psyllium Fiber - Original Texture PSYLLIUM HUSK GRANULE ORAL 20110331 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 3.4 g/11g 0224-1847_85edee86-655c-4159-834a-43d9055e75ab 0224-1847 HUMAN OTC DRUG KONSYL 100 Percent Natural Psyllium Fiber PSYLLIUM HUSK CAPSULE ORAL 20110331 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 20 mg/1 0224-1852_13cc1fef-3370-4775-a936-9aaddfa32e1c 0224-1852 HUMAN OTC DRUG Konsyl Orange Flavor Psyllium Fiber - Smooth Texture PSYLLIUM HUSK GRANULE ORAL 20110331 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 3.4 g/12g 0224-1855_bcc6f462-4565-4b38-8181-0727470d383a 0224-1855 HUMAN OTC DRUG KONSYL Sugar Free Orange Flavor Psyllium Fiber PSYLLIUM HUSK GRANULE ORAL 20110331 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 3.5 g/5.8g 0224-1856_b578715c-793e-4921-93ff-95de780a3b7f 0224-1856 HUMAN OTC DRUG KONSYL Easy Mix Formula Psyllium Fiber PSYLLIUM HUSK GRANULE ORAL 20110331 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 4.3 g/6g 0224-1860_b9d603ca-1de9-431c-8a24-25ae821c2d53 0224-1860 HUMAN OTC DRUG Konsyl Overnight Relief Senna Prompt PLANTAGO SEED, SENNOSIDES CAPSULE ORAL 20110401 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PLANTAGO SEED; SENNOSIDES 500; 9 mg/1; mg/1 0224-1866_3cd6f885-3a30-4b8d-8d6a-9fd45035382c 0224-1866 HUMAN OTC DRUG KONSYL Sugar Free Orange Flavor Psyllium Fiber Psyllium Hydrophilic Mucilloid GRANULE ORAL 20130620 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 3.5 g/5.8g 0225-0295_3644a71e-d5c1-456f-8446-6e7733be9e89 0225-0295 HUMAN PRESCRIPTION DRUG ANASPAZ HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING ORAL; SUBLINGUAL 19730102 UNAPPROVED DRUG OTHER BF ASCHER AND CO INC HYOSCYAMINE SULFATE .125 mg/1 0225-0360_03e598d8-8da8-2dd0-e054-00144ff88e88 0225-0360 HUMAN OTC DRUG MOBISYL TROLAMINE SALICYLATE CREAM TOPICAL 20140919 OTC MONOGRAPH NOT FINAL part348 BF ASCHER AND CO INC TROLAMINE SALICYLATE 10 g/100g 0225-0495_03c16d33-8f5a-0184-e054-00144ff8d46c 0225-0495 HUMAN OTC DRUG ITCH X BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE GEL TOPICAL 20140919 OTC MONOGRAPH NOT FINAL part348 BF ASCHER AND CO INC BENZYL ALCOHOL; PRAMOXINE HYDROCHLORIDE 10; 1 g/100g; g/100g 0225-0516_03f85dbb-a13b-3126-e054-00144ff8d46c 0225-0516 HUMAN OTC DRUG ITCH-X PRAMOXINE HCL/BENZYL ALCOHOL SPRAY TOPICAL 20140919 OTC MONOGRAPH NOT FINAL part348 BF ASCHER AND CO INC BENZYL ALCOHOL; PRAMOXINE HYDROCHLORIDE 10; 1 g/100mL; g/100mL 0225-0580_03d29b11-debb-3727-e054-00144ff8d46c 0225-0580 HUMAN OTC DRUG CONGESTAC PSEUDOEPHEDRINE HCL/GUAIFENESIN TABLET, FILM COATED ORAL 20140919 OTC MONOGRAPH FINAL part341 BF ASCHER AND CO INC GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 400; 60 mg/1; mg/1 0225-0610_03e598d8-8da9-2dd0-e054-00144ff88e88 0225-0610 HUMAN OTC DRUG BENZEDREX 09-19-2014 PROPYLHEXEDRINE INHALANT NASAL 20140919 OTC MONOGRAPH FINAL part341 BF ASCHER AND CO INC PROPYLHEXEDRINE 250 mg/1 0228-1112_13f01e59-e7fb-41f3-b737-716fae6ccc34 0228-1112 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 ANDA ANDA091022 Actavis Elizabeth LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0228-1113_13f01e59-e7fb-41f3-b737-716fae6ccc34 0228-1113 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 ANDA ANDA091022 Actavis Elizabeth LLC DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0228-1114_13f01e59-e7fb-41f3-b737-716fae6ccc34 0228-1114 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 ANDA ANDA091022 Actavis Elizabeth LLC DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0228-1115_13f01e59-e7fb-41f3-b737-716fae6ccc34 0228-1115 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 ANDA ANDA091022 Actavis Elizabeth LLC DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0228-1116_13f01e59-e7fb-41f3-b737-716fae6ccc34 0228-1116 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 ANDA ANDA091022 Actavis Elizabeth LLC DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0228-1117_13f01e59-e7fb-41f3-b737-716fae6ccc34 0228-1117 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 ANDA ANDA091022 Actavis Elizabeth LLC DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0228-2027_5d876462-2509-4024-ab4d-14e6c3c33d7e 0228-2027 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19950103 ANDA ANDA074342 Actavis Elizabeth LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-2029_5d876462-2509-4024-ab4d-14e6c3c33d7e 0228-2029 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19950103 ANDA ANDA074342 Actavis Elizabeth LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-2031_5d876462-2509-4024-ab4d-14e6c3c33d7e 0228-2031 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19950103 ANDA ANDA074342 Actavis Elizabeth LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-2039_5d876462-2509-4024-ab4d-14e6c3c33d7e 0228-2039 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19950103 ANDA ANDA074342 Actavis Elizabeth LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-2057_cdd3dc93-9266-4bd0-8d83-7478627e4a39 0228-2057 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070103 ANDA ANDA071403 Actavis Elizabeth LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-2059_cdd3dc93-9266-4bd0-8d83-7478627e4a39 0228-2059 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 Actavis Elizabeth LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-2063_cdd3dc93-9266-4bd0-8d83-7478627e4a39 0228-2063 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070108 ANDA ANDA071141 Actavis Elizabeth LLC LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-2067_2e8d64b3-1712-4867-bbe6-c1e5f0f2e88a 0228-2067 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE, GELATIN COATED ORAL 20070102 ANDA ANDA072251 Actavis Elizabeth LLC OXAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-2069_2e8d64b3-1712-4867-bbe6-c1e5f0f2e88a 0228-2069 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE, GELATIN COATED ORAL 20070102 ANDA ANDA072252 Actavis Elizabeth LLC OXAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-2073_2e8d64b3-1712-4867-bbe6-c1e5f0f2e88a 0228-2073 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE, GELATIN COATED ORAL 20070102 ANDA ANDA072253 Actavis Elizabeth LLC OXAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-2076_182db3b4-b3cd-4905-ad4d-65b8b6326968 0228-2076 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19950123 ANDA ANDA071638 Actavis Elizabeth LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-2077_182db3b4-b3cd-4905-ad4d-65b8b6326968 0228-2077 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19950123 ANDA ANDA071620 Actavis Elizabeth LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-2127_a70aed43-d634-4e79-8e5b-3b82c16d1aa0 0228-2127 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070974 Actavis Elizabeth LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0228-2128_a70aed43-d634-4e79-8e5b-3b82c16d1aa0 0228-2128 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070975 Actavis Elizabeth LLC CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0228-2129_a70aed43-d634-4e79-8e5b-3b82c16d1aa0 0228-2129 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070976 Actavis Elizabeth LLC CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0228-2143_9ea4b4c2-4bb8-4094-ac9d-3faa008ba5aa 0228-2143 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19950103 ANDA ANDA071696 Actavis Elizabeth LLC CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0228-2167_eaa14eb1-3ca5-4803-9bf7-8fb5766dd373 0228-2167 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110404 ANDA ANDA090484 Actavis Elizabeth LLC LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0228-2269_b7140a9b-60f5-4416-8156-ffa257188f81 0228-2269 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19851017 ANDA ANDA070581 Actavis Elizabeth LLC METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0228-2348_c66868e0-bc5b-42b6-826e-a538a3e7dc09 0228-2348 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 20060115 ANDA ANDA080172 Actavis Elizabeth LLC PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 0228-2497_f804d060-a333-42dd-b0af-5ba7e79e59b0 0228-2497 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE, LIQUID FILLED ORAL 19910101 ANDA ANDA072579 Actavis Elizabeth LLC NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0228-2530_f804d060-a333-42dd-b0af-5ba7e79e59b0 0228-2530 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE, LIQUID FILLED ORAL 19900920 ANDA ANDA072556 Actavis Elizabeth LLC NIFEDIPINE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0228-2538_4985bff5-a00d-4d7b-9c45-ac8a2285d49a 0228-2538 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 19930901 ANDA ANDA074260 Actavis Elizabeth LLC CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0228-2539_4985bff5-a00d-4d7b-9c45-ac8a2285d49a 0228-2539 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 19930901 ANDA ANDA074260 Actavis Elizabeth LLC CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0228-2540_4985bff5-a00d-4d7b-9c45-ac8a2285d49a 0228-2540 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 19930901 ANDA ANDA074260 Actavis Elizabeth LLC CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0228-2550_d2e24428-678e-4749-ba75-fcbc0cfd1153 0228-2550 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Actavis Elizabeth LLC DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0228-2551_d2e24428-678e-4749-ba75-fcbc0cfd1153 0228-2551 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Actavis Elizabeth LLC DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0228-2571_f1208bc6-d41d-4cb1-8552-16ea535cd4f8 0228-2571 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 20070102 ANDA ANDA074722 Actavis Elizabeth LLC INDAPAMIDE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0228-2577_de202a27-3127-4b73-bdcb-7657072f3aa2 0228-2577 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Actavis Elizabeth LLC DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0228-2578_de202a27-3127-4b73-bdcb-7657072f3aa2 0228-2578 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Actavis Elizabeth LLC DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0228-2579_de202a27-3127-4b73-bdcb-7657072f3aa2 0228-2579 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991224 ANDA ANDA074984 Actavis Elizabeth LLC DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0228-2588_de202a27-3127-4b73-bdcb-7657072f3aa2 0228-2588 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Actavis Elizabeth LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0228-2597_f1208bc6-d41d-4cb1-8552-16ea535cd4f8 0228-2597 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 20070102 ANDA ANDA074722 Actavis Elizabeth LLC INDAPAMIDE 1.25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0228-2620_2bac6cb1-bf1e-4560-9e65-4555124a2290 0228-2620 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET ORAL 19981030 ANDA ANDA075037 Actavis Elizabeth LLC ISOSORBIDE MONONITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0228-2631_2bac6cb1-bf1e-4560-9e65-4555124a2290 0228-2631 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET ORAL 19981030 ANDA ANDA075037 Actavis Elizabeth LLC ISOSORBIDE MONONITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0228-2636_6530638c-15e1-44ca-bcc0-cc327be32ffc 0228-2636 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20040214 ANDA ANDA075694 Actavis Elizabeth LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0228-2637_6530638c-15e1-44ca-bcc0-cc327be32ffc 0228-2637 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20040214 ANDA ANDA075694 Actavis Elizabeth LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0228-2665_1575f255-97a3-4916-8f80-3cffa1ae9f75 0228-2665 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 Actavis Elizabeth LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0228-2666_1575f255-97a3-4916-8f80-3cffa1ae9f75 0228-2666 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 Actavis Elizabeth LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0228-2667_1575f255-97a3-4916-8f80-3cffa1ae9f75 0228-2667 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 Actavis Elizabeth LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0228-2672_262387ed-4c75-4b34-a33b-64ff8eb0a936 0228-2672 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20070103 ANDA ANDA040353 Actavis Elizabeth LLC SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0228-2673_262387ed-4c75-4b34-a33b-64ff8eb0a936 0228-2673 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20070103 ANDA ANDA040353 Actavis Elizabeth LLC SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0228-2717_3e663693-6ed7-48a1-aa41-8b7f74e30af0 0228-2717 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020109 ANDA ANDA075910 Actavis Elizabeth LLC DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0228-2751_d8ec845e-5794-47ca-a855-0424a836399f 0228-2751 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20050628 ANDA ANDA076716 Actavis Elizabeth LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0228-2752_d8ec845e-5794-47ca-a855-0424a836399f 0228-2752 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20050628 ANDA ANDA076716 Actavis Elizabeth LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0228-2753_d8ec845e-5794-47ca-a855-0424a836399f 0228-2753 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20050628 ANDA ANDA076716 Actavis Elizabeth LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0228-2778_3336ccaf-16dd-49a2-a3ff-15840674a3e2 0228-2778 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070810 ANDA ANDA078494 Actavis Elizabeth LLC PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0228-2779_3336ccaf-16dd-49a2-a3ff-15840674a3e2 0228-2779 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070810 ANDA ANDA078494 Actavis Elizabeth LLC PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0228-2780_3336ccaf-16dd-49a2-a3ff-15840674a3e2 0228-2780 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070810 ANDA ANDA078494 Actavis Elizabeth LLC PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0228-2781_3336ccaf-16dd-49a2-a3ff-15840674a3e2 0228-2781 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070810 ANDA ANDA078494 Actavis Elizabeth LLC PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0228-2801_2f444b6e-4806-48f6-9278-a0a4a6703e2a 0228-2801 HUMAN PRESCRIPTION DRUG Pilocarpine hydrochloride Pilocarpine hydrochloride TABLET, FILM COATED ORAL 20110913 NDA NDA020327 Actavis Elizabeth LLC PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 0228-2803_262387ed-4c75-4b34-a33b-64ff8eb0a936 0228-2803 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20070103 ANDA ANDA040353 Actavis Elizabeth LLC SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0228-2820_5b0ffd43-8907-4660-ab09-548fa2ea1b32 0228-2820 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070312 ANDA ANDA040707 Actavis Elizabeth LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0228-2837_2f444b6e-4806-48f6-9278-a0a4a6703e2a 0228-2837 HUMAN PRESCRIPTION DRUG Pilocarpine hydrochloride Pilocarpine hydrochloride TABLET, FILM COATED ORAL 20110913 NDA NDA020237 Actavis Elizabeth LLC PILOCARPINE HYDROCHLORIDE 7.5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 0228-2848_31997b39-0458-4012-a779-dbc39f5620be 0228-2848 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate CAPSULE, EXTENDED RELEASE ORAL 20140805 ANDA ANDA091482 Actavis Elizabeth LLC FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0228-2849_31997b39-0458-4012-a779-dbc39f5620be 0228-2849 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate CAPSULE, EXTENDED RELEASE ORAL 20140805 ANDA ANDA091482 Actavis Elizabeth LLC FLUVOXAMINE MALEATE 150 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0228-2850_26548354-4606-4c43-b9f9-54ca7afaa933 0228-2850 HUMAN PRESCRIPTION DRUG guanfacine guanfacine TABLET, EXTENDED RELEASE ORAL 20141201 ANDA ANDA200881 Actavis Pharma, Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0228-2851_26548354-4606-4c43-b9f9-54ca7afaa933 0228-2851 HUMAN PRESCRIPTION DRUG guanfacine guanfacine TABLET, EXTENDED RELEASE ORAL 20141201 ANDA ANDA200881 Actavis Pharma, Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0228-2853_26548354-4606-4c43-b9f9-54ca7afaa933 0228-2853 HUMAN PRESCRIPTION DRUG guanfacine guanfacine TABLET, EXTENDED RELEASE ORAL 20141201 ANDA ANDA200881 Actavis Pharma, Inc. GUANFACINE HYDROCHLORIDE 3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0228-2855_26548354-4606-4c43-b9f9-54ca7afaa933 0228-2855 HUMAN PRESCRIPTION DRUG guanfacine guanfacine TABLET, EXTENDED RELEASE ORAL 20141201 ANDA ANDA200881 Actavis Pharma, Inc. GUANFACINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0228-2878_c088a64a-27ad-41f0-8a19-797fa0e30a90 0228-2878 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20101224 ANDA ANDA076636 Actavis Elizabeth LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-2879_c088a64a-27ad-41f0-8a19-797fa0e30a90 0228-2879 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20101224 ANDA ANDA076636 Actavis Elizabeth LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-2890_68a237d9-fda8-459e-82f9-82816e3cf0a6 0228-2890 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131217 ANDA ANDA090776 Actavis Elizabeth LLC DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0228-2891_68a237d9-fda8-459e-82f9-82816e3cf0a6 0228-2891 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131217 ANDA ANDA090776 Actavis Elizabeth LLC DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0228-2892_68a237d9-fda8-459e-82f9-82816e3cf0a6 0228-2892 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131217 ANDA ANDA090776 Actavis Elizabeth LLC DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0228-2895_68e794e6-bf7b-4082-8f2c-dd014c413e7e 0228-2895 HUMAN PRESCRIPTION DRUG Doxycycline hyclate Doxycycline hyclate TABLET, DELAYED RELEASE ORAL 20131028 ANDA ANDA090134 Actavis Elizabeth LLC DOXYCYCLINE HYCLATE 75 mg/1 0228-2896_68e794e6-bf7b-4082-8f2c-dd014c413e7e 0228-2896 HUMAN PRESCRIPTION DRUG Doxycycline hyclate Doxycycline hyclate TABLET, DELAYED RELEASE ORAL 20131028 ANDA ANDA090134 Actavis Elizabeth LLC DOXYCYCLINE HYCLATE 100 mg/1 0228-2898_9b3f2744-b1b1-4763-bbd0-363135155417 0228-2898 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, EXTENDED RELEASE ORAL 20030908 ANDA ANDA076467 Actavis Elizabeth LLC GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0228-2899_9b3f2744-b1b1-4763-bbd0-363135155417 0228-2899 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, EXTENDED RELEASE ORAL 20030908 ANDA ANDA076467 Actavis Elizabeth LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0228-2900_9b3f2744-b1b1-4763-bbd0-363135155417 0228-2900 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, EXTENDED RELEASE ORAL 20030908 ANDA ANDA076467 Actavis Elizabeth LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0228-2918_f88d5ad4-6a73-4283-8881-93f7fa508233 0228-2918 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20131125 ANDA ANDA202463 Actavis Elizabeth LLC DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0228-2975_8442b580-9b3a-4e99-b221-d1ef586e8a14 0228-2975 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091557 Actavis Elizabeth LLC LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0228-2980_d354d3cd-2ddf-496a-90c1-12cfd688d3fe 0228-2980 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131210 ANDA ANDA201447 Actavis Elizabeth LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 2.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-2981_d354d3cd-2ddf-496a-90c1-12cfd688d3fe 0228-2981 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131210 ANDA ANDA201447 Actavis Elizabeth LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-2982_d354d3cd-2ddf-496a-90c1-12cfd688d3fe 0228-2982 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20130412 ANDA ANDA201447 Actavis Elizabeth LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-2983_d354d3cd-2ddf-496a-90c1-12cfd688d3fe 0228-2983 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131127 ANDA ANDA201447 Actavis Elizabeth LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-2996_ab8b786d-8c2b-4946-886a-844722affea3 0228-2996 HUMAN PRESCRIPTION DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078801 Actavis Elizabeth LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0228-3003_cdfd5711-1a1c-4b55-bf11-84ba17a0e2a3 0228-3003 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 Actavis Elizabeth LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-3004_cdfd5711-1a1c-4b55-bf11-84ba17a0e2a3 0228-3004 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 Actavis Elizabeth LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-3005_cdfd5711-1a1c-4b55-bf11-84ba17a0e2a3 0228-3005 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 Actavis Elizabeth LLC CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-3059_483e656b-8c6a-421b-98ad-1d4dc9973059 0228-3059 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20121210 ANDA ANDA077302 Actavis Elizabeth LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0228-3060_483e656b-8c6a-421b-98ad-1d4dc9973059 0228-3060 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20121210 ANDA ANDA077302 Actavis Elizabeth LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0228-3061_483e656b-8c6a-421b-98ad-1d4dc9973059 0228-3061 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20121210 ANDA ANDA077302 Actavis Elizabeth LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0228-3062_483e656b-8c6a-421b-98ad-1d4dc9973059 0228-3062 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20121210 ANDA ANDA077302 Actavis Elizabeth LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0228-3063_483e656b-8c6a-421b-98ad-1d4dc9973059 0228-3063 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20121210 ANDA ANDA077302 Actavis Elizabeth LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0228-3064_483e656b-8c6a-421b-98ad-1d4dc9973059 0228-3064 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20121210 ANDA ANDA077302 Actavis Elizabeth LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0228-3083_a0369a8e-0e24-4db5-ad39-6f339553f323 0228-3083 HUMAN PRESCRIPTION DRUG Alprazolam Extended Release Alprazolam TABLET, EXTENDED RELEASE ORAL 20070213 ANDA ANDA078056 Actavis Elizabeth LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-3084_a0369a8e-0e24-4db5-ad39-6f339553f323 0228-3084 HUMAN PRESCRIPTION DRUG Alprazolam Extended Release Alprazolam TABLET, EXTENDED RELEASE ORAL 20070213 ANDA ANDA078056 Actavis Elizabeth LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-3086_a0369a8e-0e24-4db5-ad39-6f339553f323 0228-3086 HUMAN PRESCRIPTION DRUG Alprazolam Extended Release Alprazolam TABLET, EXTENDED RELEASE ORAL 20070213 ANDA ANDA078056 Actavis Elizabeth LLC ALPRAZOLAM 3 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-3087_a0369a8e-0e24-4db5-ad39-6f339553f323 0228-3087 HUMAN PRESCRIPTION DRUG Alprazolam Extended Release Alprazolam TABLET, EXTENDED RELEASE ORAL 20070213 ANDA ANDA078056 Actavis Elizabeth LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-3090_e2af88d3-a82e-4624-af1e-656631b485f4 0228-3090 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140204 ANDA ANDA079040 Actavis Elizabeth LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3091_e2af88d3-a82e-4624-af1e-656631b485f4 0228-3091 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140204 ANDA ANDA079040 Actavis Elizabeth LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3092_e2af88d3-a82e-4624-af1e-656631b485f4 0228-3092 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140204 ANDA ANDA079040 Actavis Elizabeth LLC MORPHINE SULFATE 90 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3093_e2af88d3-a82e-4624-af1e-656631b485f4 0228-3093 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140204 ANDA ANDA079040 Actavis Elizabeth LLC MORPHINE SULFATE 120 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3116_e2af88d3-a82e-4624-af1e-656631b485f4 0228-3116 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140204 ANDA ANDA079040 Actavis Elizabeth LLC MORPHINE SULFATE 45 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3117_e2af88d3-a82e-4624-af1e-656631b485f4 0228-3117 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140204 ANDA ANDA079040 Actavis Elizabeth LLC MORPHINE SULFATE 75 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3154_09b7ced1-dcc2-46c1-9099-386579c5c57d 0228-3154 HUMAN PRESCRIPTION DRUG Buprenorphine hydrochloride and naloxone hydrochloride dihydrate Buprenorphine hydrochloride and naloxone hydrochloride dihydrate TABLET SUBLINGUAL 20130304 ANDA ANDA091422 Actavis Elizabeth LLC BUPRENORPHINE; NALOXONE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 0228-3155_09b7ced1-dcc2-46c1-9099-386579c5c57d 0228-3155 HUMAN PRESCRIPTION DRUG Buprenorphine hydrochloride and naloxone hydrochloride dihydrate Buprenorphine hydrochloride and naloxone hydrochloride dihydrate TABLET SUBLINGUAL 20130304 ANDA ANDA091422 Actavis Elizabeth LLC BUPRENORPHINE; NALOXONE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 0228-3227_882aee70-9ebb-41b4-a4db-98c691f47e72 0228-3227 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20101231 ANDA ANDA079046 Actavis Elizabeth LLC OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3228_882aee70-9ebb-41b4-a4db-98c691f47e72 0228-3228 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20101231 ANDA ANDA079046 Actavis Elizabeth LLC OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3229_882aee70-9ebb-41b4-a4db-98c691f47e72 0228-3229 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20101231 ANDA ANDA079046 Actavis Elizabeth LLC OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3230_882aee70-9ebb-41b4-a4db-98c691f47e72 0228-3230 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20101231 ANDA ANDA079046 Actavis Elizabeth LLC OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3261_882aee70-9ebb-41b4-a4db-98c691f47e72 0228-3261 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20101231 ANDA ANDA079046 Actavis Elizabeth LLC OXYMORPHONE HYDROCHLORIDE 7.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3262_882aee70-9ebb-41b4-a4db-98c691f47e72 0228-3262 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20101231 ANDA ANDA079046 Actavis Elizabeth LLC OXYMORPHONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3263_882aee70-9ebb-41b4-a4db-98c691f47e72 0228-3263 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20101231 ANDA ANDA079046 Actavis Elizabeth LLC OXYMORPHONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3481_e87f49b8-c90f-4001-9219-505ef0e3948b 0228-3481 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101013 ANDA ANDA078179 Actavis Elizabeth LLC ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0228-3482_e87f49b8-c90f-4001-9219-505ef0e3948b 0228-3482 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110607 ANDA ANDA078179 Actavis Elizabeth LLC ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0228-3501_390f3979-3d04-4fe2-b06a-ead95875fdfe 0228-3501 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111111 NDA AUTHORIZED GENERIC NDA020616 Actavis Elizabeth LLC MORPHINE SULFATE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3502_390f3979-3d04-4fe2-b06a-ead95875fdfe 0228-3502 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111111 NDA AUTHORIZED GENERIC NDA020616 Actavis Elizabeth LLC MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3503_390f3979-3d04-4fe2-b06a-ead95875fdfe 0228-3503 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111111 NDA AUTHORIZED GENERIC NDA020616 Actavis Elizabeth LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3504_390f3979-3d04-4fe2-b06a-ead95875fdfe 0228-3504 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111111 NDA AUTHORIZED GENERIC NDA020616 Actavis Elizabeth LLC MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3505_390f3979-3d04-4fe2-b06a-ead95875fdfe 0228-3505 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111111 NDA AUTHORIZED GENERIC NDA020616 Actavis Elizabeth LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3506_390f3979-3d04-4fe2-b06a-ead95875fdfe 0228-3506 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111111 NDA AUTHORIZED GENERIC NDA020616 Actavis Elizabeth LLC MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3507_390f3979-3d04-4fe2-b06a-ead95875fdfe 0228-3507 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111111 NDA AUTHORIZED GENERIC NDA020616 Actavis Elizabeth LLC MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3508_390f3979-3d04-4fe2-b06a-ead95875fdfe 0228-3508 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111111 NDA AUTHORIZED GENERIC NDA020616 Actavis Elizabeth LLC MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0228-3640_c38b260a-3a73-48dd-985c-7963701e969c 0228-3640 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120518 ANDA ANDA090869 Actavis Elizabeh LLC ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0228-3658_c38b260a-3a73-48dd-985c-7963701e969c 0228-3658 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120518 ANDA ANDA090869 Actavis Elizabeh LLC ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0228-3659_c38b260a-3a73-48dd-985c-7963701e969c 0228-3659 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120518 ANDA ANDA090869 Actavis Elizabeh LLC ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0228-3660_c38b260a-3a73-48dd-985c-7963701e969c 0228-3660 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120518 ANDA ANDA090869 Actavis Elizabeh LLC ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0228-3661_c38b260a-3a73-48dd-985c-7963701e969c 0228-3661 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120518 ANDA ANDA090869 Actavis Elizabeh LLC ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0228-4019_f218dc4e-0a8e-4670-a0b7-30cee7147587 0228-4019 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20100316 ANDA ANDA078561 Actavis Elizabeth LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-4022_f218dc4e-0a8e-4670-a0b7-30cee7147587 0228-4022 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20100316 ANDA ANDA078561 Actavis Elizabeth LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-4024_f218dc4e-0a8e-4670-a0b7-30cee7147587 0228-4024 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20100316 ANDA ANDA078561 Actavis Elizabeth LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-4025_f218dc4e-0a8e-4670-a0b7-30cee7147587 0228-4025 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20100316 ANDA ANDA078561 Actavis Elizabeth LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0228-4029_36f62898-717f-41c4-b956-09029902584d 0228-4029 HUMAN PRESCRIPTION DRUG Oxycodone hydrochloride and Ibuprofen Oxycodone hydrochloride and Ibuprofen TABLET, FILM COATED ORAL 20081104 ANDA ANDA078769 Actavis Elizabeth LLC IBUPROFEN; OXYCODONE HYDROCHLORIDE 400; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 0228-4417_8442b580-9b3a-4e99-b221-d1ef586e8a14 0228-4417 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091557 Actavis Elizabeth LLC LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0234-0575_342cd11d-a584-4249-b2a7-4ac686993474 0234-0575 HUMAN OTC DRUG Hibiclens Chlorhexidine gluconate SOLUTION TOPICAL 19760917 NDA NDA017768 Molnlycke Health Care US, LLC CHLORHEXIDINE GLUCONATE 213 g/1000mL 0234-0575_582ac423-cf2a-4a2a-b9c6-d63a2da4b574 0234-0575 HUMAN OTC DRUG Hibiclens Chlorhexidine gluconate SOLUTION TOPICAL 19760917 NDA NDA017768 Molnlycke Health Care US, LLC CHLORHEXIDINE GLUCONATE 213 g/1000mL 0234-0587_21c3470f-a2a8-43a4-8b14-7c57e3dd2287 0234-0587 HUMAN OTC DRUG Hibistat Chlorhexidine gluconate and Isopropyl alcohol SOLUTION TOPICAL 19800523 NDA NDA018300 Molnlycke Health Care US, LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL .525; 70 g/5mL; g/5mL 0245-0003_4fc634d0-6b79-4317-8f0d-2b21add5b041 0245-0003 HUMAN PRESCRIPTION DRUG SSKI Potassium Iodide SOLUTION ORAL 19730430 UNAPPROVED DRUG OTHER Upsher-Smith Laboratories, Inc. POTASSIUM IODIDE 1 g/mL 0245-0008_16dc4caa-2d90-4201-a892-1f49aad78f89 0245-0008 HUMAN PRESCRIPTION DRUG Fortical calcitonin salmon SPRAY, METERED NASAL 20050812 NDA NDA021406 Upsher-Smith Laboratories, Inc. CALCITONIN SALMON 2200 [iU]/mL Calcitonin [Chemical/Ingredient],Calcitonin [EPC] 0245-0012_795a035f-d349-4221-89dc-0899019f3982 0245-0012 HUMAN PRESCRIPTION DRUG Sorine Sotalol Hydrochloride TABLET ORAL 20110215 ANDA ANDA075500 Upsher-Smith Laboratories, Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 0245-0013_795a035f-d349-4221-89dc-0899019f3982 0245-0013 HUMAN PRESCRIPTION DRUG Sorine Sotalol Hydrochloride TABLET ORAL 20110215 ANDA ANDA075500 Upsher-Smith Laboratories, Inc. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC] 0245-0014_795a035f-d349-4221-89dc-0899019f3982 0245-0014 HUMAN PRESCRIPTION DRUG Sorine Sotalol Hydrochloride TABLET ORAL 20110215 ANDA ANDA075500 Upsher-Smith Laboratories, Inc. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC] 0245-0015_795a035f-d349-4221-89dc-0899019f3982 0245-0015 HUMAN PRESCRIPTION DRUG Sorine Sotalol Hydrochloride TABLET ORAL 20110215 ANDA ANDA075500 Upsher-Smith Laboratories, Inc. SOTALOL HYDROCHLORIDE 240 mg/1 Antiarrhythmic [EPC] 0245-0035_da8a88cd-d72c-4328-bfca-3240b098f0fe 0245-0035 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride POWDER, FOR SOLUTION ORAL 20091101 UNAPPROVED DRUG OTHER Upsher-Smith Laboratories, Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0245-0036_7d017034-0540-4610-a63b-cac263aa7cf6 0245-0036 HUMAN PRESCRIPTION DRUG Prevalite cholestyramine POWDER, FOR SUSPENSION ORAL 19960201 ANDA ANDA073263 Upsher-Smith Laboratories Inc. CHOLESTYRAMINE 4 g/5.5g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 0245-0037_da8a88cd-d72c-4328-bfca-3240b098f0fe 0245-0037 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride POWDER, FOR SOLUTION ORAL 20091101 UNAPPROVED DRUG OTHER Upsher-Smith Laboratories, Inc. POTASSIUM CHLORIDE 25 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0245-0039_9678accc-8842-466e-bb16-ff8858b30137 0245-0039 HUMAN PRESCRIPTION DRUG Potassium Bicarbonate Potassium Bicarbonate TABLET, EFFERVESCENT ORAL 20021201 UNAPPROVED DRUG OTHER Upsher-Smith Laboratories, Inc. POTASSIUM BICARBONATE 2.5 g/1 0245-0040_01dbec9b-34d6-45fc-b520-b435dd4070c6 0245-0040 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Upsher-Smith Laboratories, Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0245-0041_01dbec9b-34d6-45fc-b520-b435dd4070c6 0245-0041 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Upsher-Smith Laboratories, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0245-0042_452bf1fd-dc5e-4eb4-a617-51f24b4fee4e 0245-0042 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Upsher-Smith Laboratories, Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0245-0043_452bf1fd-dc5e-4eb4-a617-51f24b4fee4e 0245-0043 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Upsher-Smith Laboratories, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0245-0057_57465df7-5f20-4c31-94e6-ed2f4084391c 0245-0057 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 Upsher-Smith Laboratories, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0245-0058_57465df7-5f20-4c31-94e6-ed2f4084391c 0245-0058 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 Upsher-Smith Laboratories, Inc. POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0245-0067_5c0c8e95-6dba-4603-ad70-3a21a49dff6f 0245-0067 HUMAN PRESCRIPTION DRUG Niacor niacin TABLET ORAL 20000503 ANDA ANDA040378 Upsher-Smith Laboratories Inc. NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 0245-0070_fb054121-f3f9-4488-90af-0746ca998332 0245-0070 HUMAN PRESCRIPTION DRUG Potassium Citrate potassium citrate TABLET ORAL 20060901 NDA NDA019071 Upsher-Smith Laboratories, Inc. POTASSIUM CITRATE 5 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0245-0071_fb054121-f3f9-4488-90af-0746ca998332 0245-0071 HUMAN PRESCRIPTION DRUG Potassium Citrate potassium citrate TABLET ORAL 20060901 NDA NDA019071 Upsher-Smith Laboratories, Inc. POTASSIUM CITRATE 10 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0245-0084_0228fe63-2916-4278-96bf-66b66eab18b2 0245-0084 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110502 ANDA ANDA078311 Upsher-Smith Laboratories, Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0245-0085_0228fe63-2916-4278-96bf-66b66eab18b2 0245-0085 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110502 ANDA ANDA078311 Upsher-Smith Laboratories, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0245-0086_0228fe63-2916-4278-96bf-66b66eab18b2 0245-0086 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110502 ANDA ANDA078311 Upsher-Smith Laboratories, Inc. PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0245-0087_0228fe63-2916-4278-96bf-66b66eab18b2 0245-0087 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110502 ANDA ANDA078311 Upsher-Smith Laboratories, Inc. PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0245-0136_037dcd09-61bf-4919-ac58-6b496e1fbb3a 0245-0136 HUMAN PRESCRIPTION DRUG Trianex triamcinolone acetonide OINTMENT TOPICAL 20110527 ANDA ANDA089595 Upsher-Smith Laboratories, Inc. TRIAMCINOLONE ACETONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0245-0144_05e67f83-928c-44cd-bd00-381e4ece2331 0245-0144 HUMAN PRESCRIPTION DRUG Pacerone Amiodarone Hydrochloride TABLET ORAL 20110119 ANDA ANDA075135 Upsher-Smith Laboratories, Inc. AMIODARONE HYDROCHLORIDE 100 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0245-0145_72dc445d-8ce4-478e-b8ec-9890005f9e07 0245-0145 HUMAN PRESCRIPTION DRUG Pacerone Amiodarone Hydrochloride TABLET ORAL 20000630 ANDA ANDA075315 Upsher-Smith Laboratories, Inc. AMIODARONE HYDROCHLORIDE 400 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0245-0147_05e67f83-928c-44cd-bd00-381e4ece2331 0245-0147 HUMAN PRESCRIPTION DRUG Pacerone Amiodarone Hydrochloride TABLET ORAL 20110119 ANDA ANDA075135 Upsher-Smith Laboratories, Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0245-0150_57465df7-5f20-4c31-94e6-ed2f4084391c 0245-0150 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 Upsher-Smith Laboratories, Inc. POTASSIUM CHLORIDE 1125 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0245-0168_d9cc5e64-aac6-45f4-9b81-8916e8ac9985 0245-0168 HUMAN PRESCRIPTION DRUG Clenia sulfacetamide sodium and sulfur CREAM TOPICAL 20090901 UNAPPROVED DRUG OTHER Upsher-Smith Laboratories, Inc SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0245-0169_d9cc5e64-aac6-45f4-9b81-8916e8ac9985 0245-0169 HUMAN PRESCRIPTION DRUG Clenia sulfacetamide sodium and sulfur CREAM TOPICAL 20090901 UNAPPROVED DRUG OTHER Upsher-Smith Laboratories, Inc SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0245-0178_ca393133-9b1f-421a-b27e-fb80a3988293 0245-0178 HUMAN PRESCRIPTION DRUG PreNexa Ascorbic Acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, doconexent, and docusate sodium CAPSULE, GELATIN COATED ORAL 20100525 UNAPPROVED DRUG OTHER Upsher-Smith Laboratories, Inc. .ALPHA.-TOCOPHEROL; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; TRIBASIC CALCIUM PHOSPHATE 30; 28; 400; 300; 55; 27; 1.25; 25; 160 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0245-0180_5b59555a-3cf9-4062-9e6c-e41085104d0a 0245-0180 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110121 ANDA ANDA078182 Upsher-Smith Laboratories, Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0245-0181_5b59555a-3cf9-4062-9e6c-e41085104d0a 0245-0181 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110121 ANDA ANDA078182 Upsher-Smith Laboratories, Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0245-0182_5b59555a-3cf9-4062-9e6c-e41085104d0a 0245-0182 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110121 ANDA ANDA078182 Upsher-Smith Laboratories, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0245-0211_d0786b1b-22b7-4c79-b0aa-ef7c3f3a6d06 0245-0211 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20041103 ANDA ANDA076725 Upsher-Smith Laboratories Inc. MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0245-0212_d0786b1b-22b7-4c79-b0aa-ef7c3f3a6d06 0245-0212 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20041103 ANDA ANDA076725 Upsher-Smith Laboratories Inc. MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0245-0213_d0786b1b-22b7-4c79-b0aa-ef7c3f3a6d06 0245-0213 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20041103 ANDA ANDA076725 Upsher-Smith Laboratories Inc. MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0245-0214_d724da5e-8f45-4b40-a44a-61564f70f73d 0245-0214 HUMAN PRESCRIPTION DRUG B-Nexa Pyridoxine, Folic Acid, Calcium, and Ginger TABLET ORAL 20111208 UNAPPROVED DRUG OTHER Upsher-Smith Laboratories, Inc. CALCIUM; FOLIC ACID; GINGER; PYRIDOXINE 124.1; 1.2; 100; 40 mg/1; mg/1; mg/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 0245-0215_e049ab4b-175f-4816-8a9f-6ddd0d4717d9 0245-0215 HUMAN PRESCRIPTION DRUG B-Nexa Pyridoxine, Folic Acid, Calcium, and Ginger TABLET ORAL 20120815 UNAPPROVED DRUG OTHER Upsher-Smith Laboratories, Inc. CALCIUM; FOLIC ACID; GINGER; PYRIDOXINE 124.23; 1.22; 100; 42 mg/1; mg/1; mg/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 0245-0219_98701c04-374c-4b22-91f4-445cdc7a7d3a 0245-0219 HUMAN PRESCRIPTION DRUG lamotrigine lamotrigine KIT 20110228 ANDA ANDA078310 Upsher-Smith Laboratories, Inc. 0245-0220_98701c04-374c-4b22-91f4-445cdc7a7d3a 0245-0220 HUMAN PRESCRIPTION DRUG lamotrigine lamotrigine KIT 20110228 ANDA ANDA078310 Upsher-Smith Laboratories, Inc. 0245-0221_98701c04-374c-4b22-91f4-445cdc7a7d3a 0245-0221 HUMAN PRESCRIPTION DRUG lamotrigine Lamotrigine TABLET ORAL 20110228 ANDA ANDA078310 Upsher-Smith Laboratories, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0245-0222_98701c04-374c-4b22-91f4-445cdc7a7d3a 0245-0222 HUMAN PRESCRIPTION DRUG lamotrigine Lamotrigine TABLET ORAL 20110228 ANDA ANDA078310 Upsher-Smith Laboratories, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0245-0223_98701c04-374c-4b22-91f4-445cdc7a7d3a 0245-0223 HUMAN PRESCRIPTION DRUG lamotrigine Lamotrigine TABLET ORAL 20110228 ANDA ANDA078310 Upsher-Smith Laboratories, Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0245-0224_98701c04-374c-4b22-91f4-445cdc7a7d3a 0245-0224 HUMAN PRESCRIPTION DRUG lamotrigine Lamotrigine TABLET ORAL 20110228 ANDA ANDA078310 Upsher-Smith Laboratories, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0245-0242_2e6c555c-abc4-4316-874c-4f62a1edcea7 0245-0242 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Upsher-Smith Laboratories, Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0245-0243_2e6c555c-abc4-4316-874c-4f62a1edcea7 0245-0243 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Upsher-Smith Laboratories, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0245-0245_1cb8000d-775e-440b-8afc-2b7f2982ed75 0245-0245 HUMAN PRESCRIPTION DRUG Nexa Select Rx Prenatal Vitamin with Plant-Based DHA Ascorbic Acid, .Alpha.-Tocopherol, Pyridoxine, Folic Acid, Calcium, Iron, Cholecalciferol, CRYPTHECODINIUM COHNII DHA OIL, and Docusate Sodium CAPSULE ORAL 20121217 UNAPPROVED DRUG OTHER Upsher-Smith Laboratories, Inc. .ALPHA.-TOCOPHEROL; ASCORBIC ACID; CALCIUM; CHOLECALCIFEROL; CRYPTHECODINIUM COHNII DHA OIL; DOCUSATE SODIUM; FOLIC ACID; IRON; PYRIDOXINE 30; 28; 160; 800; 750; 55; 1.25; 29; 28 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0245-0271_af616a6a-0700-4e12-8659-deace3bb9a84 0245-0271 HUMAN PRESCRIPTION DRUG oxandrolone oxandrolone TABLET ORAL 20061201 ANDA ANDA076761 Upsher-Smith Laboratories, Inc. OXANDROLONE 2.5 mg/1 CIII 0245-0272_f4946a88-a77b-4e7a-bf73-9764466f891c 0245-0272 HUMAN PRESCRIPTION DRUG oxandrolone oxandrolone TABLET ORAL 20070322 ANDA ANDA078033 Upsher-Smith Laboratories, Inc. OXANDROLONE 10 mg/1 CIII 0245-0374_32f75719-44c6-4424-aaf8-b0ec6716bafd 0245-0374 HUMAN PRESCRIPTION DRUG Nexa Plus Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol, Pyridoxine, Folic Acid, Biotin, Calcium, Iron, Docusate Calcium, and Crypthecodinium cohnii dha oil CAPSULE ORAL 20120801 UNAPPROVED DRUG OTHER Upsher-Smith Laboratories, Inc. .ALPHA.-TOCOPHEROL; ASCORBIC ACID; BIOTIN; CALCIUM; CHOLECALCIFEROL; CRYPTHECODINIUM COHNII DHA OIL; DOCUSATE CALCIUM; FOLIC ACID; IRON; PYRIDOXINE 30; 28; 250; 160; 800; 660; 55; 1.25; 29; 25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 0245-0420_2a24c828-b0ef-446a-9159-c07d374d41b7 0245-0420 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20130301 20151231 ANDA ANDA077775 Upsher-Smith Laboratories, Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0245-0421_2a24c828-b0ef-446a-9159-c07d374d41b7 0245-0421 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20130301 20151231 ANDA ANDA077775 Upsher-Smith Laboratories, Inc. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0245-0422_2a24c828-b0ef-446a-9159-c07d374d41b7 0245-0422 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20130301 20151231 ANDA ANDA077775 Upsher-Smith Laboratories, Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0245-0423_2a24c828-b0ef-446a-9159-c07d374d41b7 0245-0423 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20130301 20151231 ANDA ANDA077775 Upsher-Smith Laboratories, Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0245-0536_38218c19-e1db-437c-9522-eb238320029a 0245-0536 HUMAN PRESCRIPTION DRUG Cholestyramine Cholestyramine POWDER, FOR SUSPENSION ORAL 20120105 ANDA ANDA074557 Upsher-Smith Laboratories, Inc. CHOLESTYRAMINE 4 g/9g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 0245-0707_8badff59-5fa4-4a8a-a4e0-46800c940d2b 0245-0707 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, COATED ORAL 20110502 ANDA ANDA078499 Upsher-Smith Laboratories, Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0245-0708_8badff59-5fa4-4a8a-a4e0-46800c940d2b 0245-0708 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, COATED ORAL 20110502 ANDA ANDA078499 Upsher-Smith Laboratories, Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0245-0709_8badff59-5fa4-4a8a-a4e0-46800c940d2b 0245-0709 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, COATED ORAL 20110502 ANDA ANDA078499 Upsher-Smith Laboratories, Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0245-0710_8badff59-5fa4-4a8a-a4e0-46800c940d2b 0245-0710 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, COATED ORAL 20110502 ANDA ANDA078499 Upsher-Smith Laboratories, Inc. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0245-0860_02c677d0-e310-4207-8958-9873f5819be6 0245-0860 HUMAN PRESCRIPTION DRUG Vandazole Metronidazole GEL VAGINAL 20051004 NDA NDA021806 Upsher-Smith Laboratories, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0245-0871_095cf807-d1ab-4c5c-bbe3-af795e20668e 0245-0871 HUMAN PRESCRIPTION DRUG VOGELXO Testosterone GEL TOPICAL 20140609 NDA NDA204399 Upsher-Smith Laboratories, Inc. TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0245-0872_095cf807-d1ab-4c5c-bbe3-af795e20668e 0245-0872 HUMAN PRESCRIPTION DRUG VOGELXO Testosterone GEL, METERED TOPICAL 20140609 NDA NDA204399 Upsher-Smith Laboratories, Inc. TESTOSTERONE 12.5 mg/1.25g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0245-0880_f978077b-ac56-402e-9219-77597ba6d82a 0245-0880 HUMAN PRESCRIPTION DRUG Divigel Estradiol GEL TOPICAL 20110228 NDA NDA022038 Upsher-Smith Laboratories, Inc. ESTRADIOL .25 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0245-0881_f978077b-ac56-402e-9219-77597ba6d82a 0245-0881 HUMAN PRESCRIPTION DRUG Divigel Estradiol GEL TOPICAL 20110228 NDA NDA022038 Upsher-Smith Laboratories, Inc. ESTRADIOL .5 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0245-0882_f978077b-ac56-402e-9219-77597ba6d82a 0245-0882 HUMAN PRESCRIPTION DRUG Divigel Estradiol GEL TOPICAL 20110228 NDA NDA022038 Upsher-Smith Laboratories, Inc. ESTRADIOL 1 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0245-1071_a06a3b68-9573-4266-9900-d34220cd3a6b 0245-1071 HUMAN PRESCRIPTION DRUG QUDEXY XR Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140411 NDA NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0245-1072_a06a3b68-9573-4266-9900-d34220cd3a6b 0245-1072 HUMAN PRESCRIPTION DRUG QUDEXY XR Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140411 NDA NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0245-1073_a06a3b68-9573-4266-9900-d34220cd3a6b 0245-1073 HUMAN PRESCRIPTION DRUG QUDEXY XR Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140411 NDA NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0245-1074_a06a3b68-9573-4266-9900-d34220cd3a6b 0245-1074 HUMAN PRESCRIPTION DRUG QUDEXY XR Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140411 NDA NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0245-1075_a06a3b68-9573-4266-9900-d34220cd3a6b 0245-1075 HUMAN PRESCRIPTION DRUG QUDEXY XR Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140411 NDA NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0256-0185_54753dd9-dd90-40ee-a50d-47a7fa5b4754 0256-0185 HUMAN PRESCRIPTION DRUG Nephrocaps Ascorbic Acid, Folic Acid, Niacin, Thiamine, Riboflavin, Pyridoxine, Cyanocobalamin, Pantothenic Acid, Biotin CAPSULE, LIQUID FILLED ORAL 19930201 UNAPPROVED DRUG OTHER Fleming & Company, Pharmaceuticals ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; THIAMINE 100; 150; 6; 1; 20; 5; 10; 1.7; 1.5 mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 0256-0210_a79acae4-af7a-4054-9440-c6433ac9acb1 0256-0210 HUMAN OTC DRUG ThyroShield Potassium Iodide SOLUTION ORAL 20050401 ANDA ANDA077218 Fleming & Company, Pharmaceuticals POTASSIUM IODIDE 65 mg/mL 0258-4000_cb7cdfb2-19b8-4ddd-a9f5-6978e997e463 0258-4000 HUMAN PRESCRIPTION DRUG acamprosate calcium acamprosate calcium TABLET, COATED ORAL 20050111 NDA NDA021431 Forest Laboratories, Inc. ACAMPROSATE CALCIUM 333 mg/1 0259-0501_22138167-a846-49f8-b669-a115c483c3ae 0259-0501 HUMAN PRESCRIPTION DRUG Cuvposa glycopyrrolate LIQUID ORAL 20130101 NDA NDA022571 Merz Pharmaceuticals, LLC GLYCOPYRROLATE 1 mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0259-1101_4c3f337b-3817-4c51-93b0-17926a9fc079 0259-1101 HUMAN OTC DRUG Mederma for Kids Allantoin GEL TOPICAL 20140501 OTC MONOGRAPH FINAL part347 Merz Pharmaceuticals, LLC ALLANTOIN 10 mg/g 0259-1102_e7a673a4-a17a-4844-891a-c2d93b3ce4bb 0259-1102 HUMAN PRESCRIPTION DRUG Naftin Naftifine Hydrochloride CREAM TOPICAL 20120301 NDA NDA019599 Merz Pharmaceuticals, LLC NAFTIFINE HYDROCHLORIDE 10 mg/2g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 0259-1105_8179de3e-b6f5-4fc1-8779-ecb3d019abd2 0259-1105 HUMAN OTC DRUG Mederma Advanced Scar Allantoin GEL TOPICAL 20131101 OTC MONOGRAPH FINAL part347 Merz Pharmaceuticals, LLC ALLANTOIN 5 mg/g 0259-1139_9e08729f-3ade-4d2d-96ab-cb1f962885f7 0259-1139 HUMAN PRESCRIPTION DRUG Aluvea Urea CREAM TOPICAL 20110415 UNAPPROVED DRUG OTHER Merz Pharmaceuticals, LLC UREA 39 g/100g 0259-1202_387726b6-3d9f-4f1e-bc56-06a806e5830f 0259-1202 HUMAN PRESCRIPTION DRUG Naftin Naftifine Hydrochloride GEL TOPICAL 20130901 NDA NDA204286 Merz Pharmaceuticals, LLC NAFTIFINE HYDROCHLORIDE 2 g/100g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 0259-1420_03eb05c6-af6e-453e-828e-247d91eb6185 0259-1420 HUMAN PRESCRIPTION DRUG Onmel ITRACONAZOLE TABLET ORAL 20121101 NDA NDA022484 Merz Pharmaceuticals, LLC ITRACONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0259-1605_9f832c9b-7b81-4874-90c3-c5adda4d7717 0259-1605 HUMAN PRESCRIPTION DRUG Xeomin incobotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20100901 BLA BLA125360 Merz Pharmaceuticals, LLC BOTULINUM TOXIN TYPE A 50 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] 0259-1610_9f832c9b-7b81-4874-90c3-c5adda4d7717 0259-1610 HUMAN PRESCRIPTION DRUG Xeomin incobotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20100901 BLA BLA125360 Merz Pharmaceuticals, LLC BOTULINUM TOXIN TYPE A 100 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] 0259-2102_ec878792-ccc0-4055-adcb-2f93b747d1ca 0259-2102 HUMAN OTC DRUG Mederma Stretch Marks Therapy dimethicone CREAM TOPICAL 20131201 OTC MONOGRAPH FINAL part347 Merz Pharmaceuticals, LLC DIMETHICONE 20 mg/g 0259-2202_7bba7bce-e4c1-41ef-aa0b-b0eb4411abd2 0259-2202 HUMAN OTC DRUG Mederma PM Dimethicone CREAM TOPICAL 20131101 OTC MONOGRAPH FINAL part347 Merz Pharmaceuticals, LLC DIMETHICONE 20 mg/g 0259-3192_a0c53526-3e27-4898-83c2-7b948b010137 0259-3192 HUMAN OTC DRUG Mederma AVOBENZONE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20071201 OTC MONOGRAPH FINAL part352 Merz Pharmaceuticals, LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 30; 100; 60 mg/g; mg/g; mg/g 0259-4126_00829a7d-d654-41d1-a4cd-fd61dd93c1fb 0259-4126 HUMAN PRESCRIPTION DRUG Naftin NAFTIFINE HYDROCHLORIDE CREAM TOPICAL 19980601 NDA NDA019599 Merz Pharmaceuticals, LLC NAFTIFINE HYDROCHLORIDE 10 mg/g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 0259-4770_f62fc834-0f0b-4dd2-a2d9-a49274e51e34 0259-4770 HUMAN PRESCRIPTION DRUG Naftin NAFTIFINE HYDROCHLORIDE GEL TOPICAL 19901001 NDA NDA019356 Merz Pharmaceuticals, LLC NAFTIFINE HYDROCHLORIDE 10 mg/g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 0264-1101_9925a78e-b022-4114-b7a3-55337179ae88 0264-1101 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE INJECTION, SOLUTION INTRAVENOUS 20110727 20150101 UNAPPROVED DRUG OTHER B. Braun Medical Inc. DEXTROSE 5 g/100mL 0264-1102_9925a78e-b022-4114-b7a3-55337179ae88 0264-1102 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE INJECTION, SOLUTION INTRAVENOUS 20110727 20150101 UNAPPROVED DRUG OTHER B. Braun Medical Inc. DEXTROSE 5 g/100mL 0264-1207_9925a78e-b022-4114-b7a3-55337179ae88 0264-1207 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE INJECTION, SOLUTION INTRAVENOUS 20110727 20150101 UNAPPROVED DRUG OTHER B. Braun Medical Inc. DEXTROSE 10 g/100mL 0264-1290_2e0e3715-ffd6-4f3c-b61d-f6f27b1d43ea 0264-1290 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE INJECTION, SOLUTION INTRAVENOUS 20120313 UNAPPROVED DRUG OTHER B. Braun Medical Inc. DEXTROSE MONOHYDRATE 70 g/100mL 0264-1510_e2335516-28c6-449a-871d-747350f5edf9 0264-1510 HUMAN PRESCRIPTION DRUG Dextrose Dextrose INJECTION, SOLUTION INTRAVENOUS 19731221 NDA NDA016730 B. Braun Medical Inc. DEXTROSE MONOHYDRATE 50 mg/mL 0264-1800_4bf22bed-d1d8-41e1-a62a-fba940fd34a8 0264-1800 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19780208 NDA NDA017464 B. Braun Medical Inc. SODIUM CHLORIDE 9 mg/mL 0264-1909_2d6d3c1f-4ea9-485c-b7b2-46c2d27d3f8d 0264-1909 HUMAN PRESCRIPTION DRUG NephrAmine HISTIDINE, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE, and SODIUM BISULFITE INJECTION, SOLUTION INTRAVENOUS 19780224 NDA NDA017766 B. Braun Medical Inc. CYSTEINE HYDROCHLORIDE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE .014; .25; .56; .88; .64; .88; .88; .4; .2; .64 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 0264-1915_1c1b063a-550a-4172-863f-564f20c49c72 0264-1915 HUMAN PRESCRIPTION DRUG ProcalAmine GLYCERIN, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, GLYCINE, ARGININE, HISTIDINE, PROLINE, SERINE, CYSTEINE, SODIUM ACETATE, MAGNESIUM ACETATE, CALCIUM ACETATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, PHOSPHORIC ACID, and POTASSIUM METABISULFITE INJECTION INTRAVENOUS 19820506 NDA NDA018582 B. Braun Medical Inc. ALANINE; ARGININE; CALCIUM ACETATE; CYSTEINE HYDROCHLORIDE; GLYCERIN; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; VALINE .21; .29; .026; .014; 3; .42; .085; .21; .27; .22; .054; .16; .17; .041; .15; .34; .18; .2; .12; .12; .046; .2 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient],Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0264-1940_468dc02f-1933-499f-a1f5-93eff27e4d6b 0264-1940 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE PARENTERAL 19780321 ANDA ANDA085870 B. Braun Medical Inc. POTASSIUM CHLORIDE 14.9 g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-1943_799c5123-e3fb-4311-94db-274870603a52 0264-1943 HUMAN PRESCRIPTION DRUG Hyperlyte CR Multi Electrolyte Concentrate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20120412 UNAPPROVED DRUG OTHER B. Braun Medical Inc. CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; SODIUM ACETATE; SODIUM CHLORIDE .37; .51; 1.96; .68; 1.17 g/20mL; g/20mL; g/20mL; g/20mL; g/20mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-1965_c94d9a39-e232-4333-8c74-095df44d56e7 0264-1965 HUMAN PRESCRIPTION DRUG HESPAN Hetastarch in Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19910404 NDA NDA890105 B. Braun Medical Inc. HETASTARCH; SODIUM CHLORIDE 6; .9 g/100mL; g/100mL Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [Chemical/Ingredient] 0264-2101_bcf719f0-b005-4f01-b264-43ad3669b9a9 0264-2101 HUMAN PRESCRIPTION DRUG Sterile Water Water IRRIGANT IRRIGATION 19700910 NDA NDA016734 B. Braun Medical Inc. WATER 1 mL/mL 0264-2201_6f7aa749-d391-4f57-85b2-45d889efc157 0264-2201 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride IRRIGANT IRRIGATION 20090914 NDA NDA016733 B. Braun Medical Inc. SODIUM CHLORIDE .9 g/100mL 0264-2202_ecf6a0b6-b959-401c-99a4-93bc9fe8e546 0264-2202 HUMAN PRESCRIPTION DRUG Ringers Sodium Chloride, Potassium Chloride, and Calcium Chloride IRRIGANT IRRIGATION 19790806 NDA NDA018156 B. Braun Medical Inc. CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE .033; .03; .86 g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0264-2203_7c56c5b1-0a48-43b6-b39c-954e9735d333 0264-2203 HUMAN PRESCRIPTION DRUG Lactated Ringers Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride IRRIGANT IRRIGATION 19821227 NDA NDA018681 B. Braun Medical Inc. CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE .02; .03; .6; .31 g/100mL; g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0264-2205_6a839778-068d-4ddd-9fdc-6cdec05c10bd 0264-2205 HUMAN PRESCRIPTION DRUG Physiolyte Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, and Magnesium Chloride IRRIGANT IRRIGATION 19840608 NDA NDA019024 B. Braun Medical Inc. MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE .03; .037; .37; .53; .5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0264-2301_9b645c76-5937-4845-81c3-a3e2e5948eba 0264-2301 HUMAN PRESCRIPTION DRUG Sorbitol Sorbitol IRRIGANT IRRIGATION 19780216 NDA NDA016741 B. Braun Medical Inc. SORBITOL 3.3 g/100mL 0264-2302_b1e62532-7654-460a-81fe-5110366ff7c8 0264-2302 HUMAN PRESCRIPTION DRUG Glycine Glycine IRRIGANT IRRIGATION 19780206 NDA NDA016784 B. Braun Medical Inc. GLYCINE 1.5 g/100mL 0264-2303_a6df35d3-121c-42e9-ae15-5ca17bd286a2 0264-2303 HUMAN PRESCRIPTION DRUG Mannitol Mannitol IRRIGANT IRRIGATION 19780210 NDA NDA016772 B. Braun Medical Inc. MANNITOL 5 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 0264-2304_e5500abd-7ea0-4bd2-bb43-bfe581ca7474 0264-2304 HUMAN PRESCRIPTION DRUG Acetic Acid Acetic Acid IRRIGANT IRRIGATION 19790806 NDA NDA018161 B. Braun Medical Inc. ACETIC ACID .25 g/100mL 0264-2514_f0f620d0-55f9-41b8-a52e-40278165f128 0264-2514 HUMAN PRESCRIPTION DRUG Balanced Salt Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate SOLUTION IRRIGATION 20100203 ANDA ANDA091387 B. Braun Medical Inc. CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE .48; .3; .75; 3.9; 6.4; 1.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0264-3103_e54aedef-4aca-489d-9409-ffe8bb3297d4 0264-3103 HUMAN PRESCRIPTION DRUG Cefazolin Sodium Cefazolin Sodium SOLUTION INTRAVENOUS 20000727 NDA NDA050779 B. Braun Medical Inc. CEFAZOLIN SODIUM 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0264-3105_e54aedef-4aca-489d-9409-ffe8bb3297d4 0264-3105 HUMAN PRESCRIPTION DRUG Cefazolin Sodium Cefazolin Sodium SOLUTION INTRAVENOUS 20120113 NDA NDA050779 B. Braun Medical Inc. CEFAZOLIN SODIUM 2 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0264-3123_e2a528c2-4699-451d-98f8-3129aa946780 0264-3123 HUMAN PRESCRIPTION DRUG Cefoxitin and Dextrose CEFOXITIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20060310 NDA NDA065214 B. Braun Medical Inc. CEFOXITIN SODIUM 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0264-3125_e2a528c2-4699-451d-98f8-3129aa946780 0264-3125 HUMAN PRESCRIPTION DRUG Cefoxitin and Dextrose CEFOXITIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20060310 NDA NDA065214 B. Braun Medical Inc. CEFOXITIN SODIUM 2 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0264-3143_ea583795-d769-4858-a2fa-8b8c3fa98491 0264-3143 HUMAN PRESCRIPTION DRUG Ceftazidime and Dextrose CEFTAZIDIME INJECTION, SOLUTION INTRAVENOUS 20110613 NDA NDA050823 B. Braun Medical Inc. CEFTAZIDIME 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0264-3145_ea583795-d769-4858-a2fa-8b8c3fa98491 0264-3145 HUMAN PRESCRIPTION DRUG Ceftazidime and Dextrose CEFTAZIDIME INJECTION, SOLUTION INTRAVENOUS 20110613 NDA NDA050823 B. Braun Medical Inc. CEFTAZIDIME 2 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0264-3153_b7e501be-5190-4a1a-ac81-ef07398f85d3 0264-3153 HUMAN PRESCRIPTION DRUG CEFTRIAXONE AND DEXTROSE CEFTRIAXONE INJECTION, SOLUTION INTRAVENOUS 20050420 NDA NDA050796 B. Braun Medical Inc. CEFTRIAXONE SODIUM 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0264-3155_b7e501be-5190-4a1a-ac81-ef07398f85d3 0264-3155 HUMAN PRESCRIPTION DRUG CEFTRIAXONE AND DEXTROSE CEFTRIAXONE INJECTION, SOLUTION INTRAVENOUS 20050420 NDA NDA050796 B. Braun Medical Inc. CEFTRIAXONE SODIUM 2 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0264-3173_367e39ed-cb4c-443e-87e2-3f8ea50213c7 0264-3173 HUMAN PRESCRIPTION DRUG Cefotetan and Dextrose CEFOTETAN and DEXTROSE INJECTION, SOLUTION INTRAVENOUS 20100820 NDA NDA065430 B. Braun Medical Inc. CEFOTETAN DISODIUM 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0264-3175_367e39ed-cb4c-443e-87e2-3f8ea50213c7 0264-3175 HUMAN PRESCRIPTION DRUG Cefotetan and Dextrose CEFOTETAN and DEXTROSE INJECTION, SOLUTION INTRAVENOUS 20100820 NDA NDA065430 B. Braun Medical Inc. CEFOTETAN DISODIUM 2 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0264-3193_968ef12b-cb19-465e-9458-54d1d42e862c 0264-3193 HUMAN PRESCRIPTION DRUG CEFEPIME HYDROCHLORIDE AND DEXTROSE CEFEPIME HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20100506 NDA NDA050821 B. Braun Medical Inc. CEFEPIME HYDROCHLORIDE 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0264-3195_968ef12b-cb19-465e-9458-54d1d42e862c 0264-3195 HUMAN PRESCRIPTION DRUG CEFEPIME HYDROCHLORIDE AND DEXTROSE CEFEPIME HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20100506 NDA NDA050821 B. Braun Medical Inc. CEFEPIME HYDROCHLORIDE 2 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0264-3200_3862487e-1e55-4cb4-aeae-e3a576c744cf 0264-3200 HUMAN PRESCRIPTION DRUG Amino Acids LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE SOLUTION INTRAVENOUS 20120413 ANDA ANDA091112 B. Braun Medical Inc. ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960 g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0264-3205_3862487e-1e55-4cb4-aeae-e3a576c744cf 0264-3205 HUMAN PRESCRIPTION DRUG Amino Acids LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE SOLUTION INTRAVENOUS 20120413 ANDA ANDA091112 B. Braun Medical Inc. ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960 g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0264-4000_4735d060-8f12-4525-9397-14bd3d818d68 0264-4000 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE SODIUM CHLORIDE SOLUTION INTRAVENOUS 20100623 20151001 UNAPPROVED DRUG OTHER B. Braun Medical Inc. SODIUM CHLORIDE .9 g/100mL 0264-4001_4735d060-8f12-4525-9397-14bd3d818d68 0264-4001 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE SODIUM CHLORIDE SOLUTION INTRAVENOUS 20110908 20151001 UNAPPROVED DRUG OTHER B. Braun Medical Inc. SODIUM CHLORIDE .9 g/100mL 0264-4002_4735d060-8f12-4525-9397-14bd3d818d68 0264-4002 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE SODIUM CHLORIDE SOLUTION INTRAVENOUS 20110311 20151001 UNAPPROVED DRUG OTHER B. Braun Medical Inc. SODIUM CHLORIDE .9 g/100mL 0264-4021_4735d060-8f12-4525-9397-14bd3d818d68 0264-4021 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE SODIUM CHLORIDE SOLUTION INTRAVENOUS 20110908 20151001 UNAPPROVED DRUG OTHER B. Braun Medical Inc. SODIUM CHLORIDE .45 g/100mL 0264-4460_98ac3792-f408-4726-a598-65579e51b05f 0264-4460 HUMAN PRESCRIPTION DRUG NutriLipid I.V. Fat Emulsion Soybean Oil INJECTION, SOLUTION INTRAVENOUS 20140630 NDA NDA019531 B. Braun Medical Inc. SOYBEAN OIL 20 g/100mL 0264-5535_e7c8dd97-1352-4086-88ca-58de493b18ad 0264-5535 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE SOLUTION INTRAVENOUS 19830929 NDA NDA018900 B. Braun Medical Inc. METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0264-7273_77e5a2dc-7324-4a3c-910f-11c7f9efb34e 0264-7273 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION INTRAVENOUS 19880217 NDA NDA019630 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 3.3; .15; .3 g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7385_ba17af6b-3260-4448-bdfc-ab473cd80982 0264-7385 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION INTRAVENOUS 20140904 NDA NDA019633 B. Braun Medical Inc. WATER 1 mL/mL 0264-7386_ce01ad9d-be9e-44c6-8e45-0b07f9e2edb6 0264-7386 HUMAN PRESCRIPTION DRUG Sterile Water Sterile Water IRRIGANT IRRIGATION 20130913 NDA NDA016734 B. Braun Medical Inc. WATER 100 mL/100mL 0264-7388_dacd7f8d-8d59-44a4-975d-461852c1eb73 0264-7388 HUMAN PRESCRIPTION DRUG Sodium Chloride for Irrigation Sodium Chloride for Irrigation SOLUTION IRRIGATION 20130419 NDA NDA016733 B. Braun Medical Inc. SODIUM CHLORIDE .9 g/100mL 0264-7389_1fe16606-f6cf-4bb5-8737-b9f96b51c12e 0264-7389 HUMAN PRESCRIPTION DRUG Lactated Ringers Irrigation sodium chloride, sodium lactate, potassium chloride and calcium chloride SOLUTION IRRIGATION 20140902 NDA NDA018681 B. Braun Medical Inc. CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20; 30; 600; 310 mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0264-7390_d38469b0-8280-4c42-8c67-dc5ff66adc93 0264-7390 HUMAN PRESCRIPTION DRUG Glycine Glycine IRRIGANT IRRIGATION 20131204 NDA NDA016784 B. Braun Medical Inc. GLYCINE 1.5 g/100mL 0264-7510_6c95bbfe-e578-4b18-b221-df37aea9749a 0264-7510 HUMAN PRESCRIPTION DRUG DEXTROSE DEXTROSE SOLUTION INTRAVENOUS 19880202 NDA NDA019626 B. Braun Medical Inc. DEXTROSE 5 g/100mL 0264-7520_6c95bbfe-e578-4b18-b221-df37aea9749a 0264-7520 HUMAN PRESCRIPTION DRUG DEXTROSE DEXTROSE SOLUTION INTRAVENOUS 19880202 NDA NDA019626 B. Braun Medical Inc. DEXTROSE 10 g/100mL 0264-7578_bdb4a9b7-1768-44c8-ab30-b16ba2d28cfd 0264-7578 HUMAN PRESCRIPTION DRUG Mannitol MANNITOL INJECTION, SOLUTION INTRAVENOUS 19930726 NDA NDA020006 B. Braun Medical Inc. MANNITOL 20 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 0264-7605_65b1c173-7c7b-466d-be7c-e8c3c2c8f001 0264-7605 HUMAN PRESCRIPTION DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 2.5; .45 g/100mL; g/100mL 0264-7608_65b1c173-7c7b-466d-be7c-e8c3c2c8f001 0264-7608 HUMAN PRESCRIPTION DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 3.3; .3 g/100mL; g/100mL 0264-7610_65b1c173-7c7b-466d-be7c-e8c3c2c8f001 0264-7610 HUMAN PRESCRIPTION DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 5; .9 g/100mL; g/100mL 0264-7612_65b1c173-7c7b-466d-be7c-e8c3c2c8f001 0264-7612 HUMAN PRESCRIPTION DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 5; .45 g/100mL; g/100mL 0264-7614_65b1c173-7c7b-466d-be7c-e8c3c2c8f001 0264-7614 HUMAN PRESCRIPTION DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 5; .33 g/100mL; g/100mL 0264-7616_65b1c173-7c7b-466d-be7c-e8c3c2c8f001 0264-7616 HUMAN PRESCRIPTION DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 5; .2 g/100mL; g/100mL 0264-7622_65b1c173-7c7b-466d-be7c-e8c3c2c8f001 0264-7622 HUMAN PRESCRIPTION DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 10; .45 g/100mL; g/100mL 0264-7623_65b1c173-7c7b-466d-be7c-e8c3c2c8f001 0264-7623 HUMAN PRESCRIPTION DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 10; .2 g/100mL; g/100mL 0264-7625_469ce3e3-9cde-406f-a967-00e9744d12db 0264-7625 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE IN DEXTROSE DEXTROSE and POTASSIUM CHLORIDE SOLUTION INTRAVENOUS 19890929 NDA NDA019699 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE 5; .15 g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7628_469ce3e3-9cde-406f-a967-00e9744d12db 0264-7628 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE IN DEXTROSE DEXTROSE and POTASSIUM CHLORIDE SOLUTION INTRAVENOUS 19890929 NDA NDA019699 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE 5; .3 g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7634_77e5a2dc-7324-4a3c-910f-11c7f9efb34e 0264-7634 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION INTRAVENOUS 19880217 NDA NDA019630 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; .075; .45 g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7635_77e5a2dc-7324-4a3c-910f-11c7f9efb34e 0264-7635 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION INTRAVENOUS 19880217 NDA NDA019630 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; .15; .45 g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7636_77e5a2dc-7324-4a3c-910f-11c7f9efb34e 0264-7636 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION INTRAVENOUS 19880217 NDA NDA019630 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; .22; .45 g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7638_77e5a2dc-7324-4a3c-910f-11c7f9efb34e 0264-7638 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION INTRAVENOUS 19880217 NDA NDA019630 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; .3; .45 g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7644_77e5a2dc-7324-4a3c-910f-11c7f9efb34e 0264-7644 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION INTRAVENOUS 19880217 NDA NDA019630 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; .075; .2 g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7645_77e5a2dc-7324-4a3c-910f-11c7f9efb34e 0264-7645 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION INTRAVENOUS 19880217 NDA NDA019630 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; .15; .2 g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7646_77e5a2dc-7324-4a3c-910f-11c7f9efb34e 0264-7646 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION INTRAVENOUS 19880217 NDA NDA019630 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; .22; .2 g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7648_77e5a2dc-7324-4a3c-910f-11c7f9efb34e 0264-7648 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION INTRAVENOUS 19880217 NDA NDA019630 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; .3; .2 g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7652_77e5a2dc-7324-4a3c-910f-11c7f9efb34e 0264-7652 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION INTRAVENOUS 19880217 NDA NDA019630 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; .15; .9 g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7655_77e5a2dc-7324-4a3c-910f-11c7f9efb34e 0264-7655 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION INTRAVENOUS 19880217 NDA NDA019630 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; .15; .33 g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7663_77e5a2dc-7324-4a3c-910f-11c7f9efb34e 0264-7663 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION INTRAVENOUS 19880217 NDA NDA019630 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 10; .15; .2 g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7682_77e5a2dc-7324-4a3c-910f-11c7f9efb34e 0264-7682 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION INTRAVENOUS 19880217 NDA NDA019630 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; .3; .9 g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7703_5ade9a91-52fe-4087-8918-e2721e2f43bb 0264-7703 HUMAN PRESCRIPTION DRUG Isolyte S SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19890929 NDA NDA019711 B. Braun Medical Inc. MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE .03; .037; .37; .53; .5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0264-7704_cb81fe4a-10a7-4e24-aa4f-b4315fcfe39b 0264-7704 HUMAN PRESCRIPTION DRUG Isolyte S in Dextrose Hydrous Dextrose, Sodium Chloride, Sodium Gluconate, Sodium Acetate Trihydrate, Potassium Chloride and Magnesium Chloride Hexahydrate INJECTION, SOLUTION INTRAVENOUS 19930809 ANDA ANDA019843 B. Braun Medical Inc. DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE 5; .03; .037; .37; .53; .5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0264-7707_db7b5796-26b4-4bd5-abc8-ce7a2b889e41 0264-7707 HUMAN PRESCRIPTION DRUG Isolyte S pH 7.4 SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE INJECTION, SOLUTION INTRAVENOUS 19890929 NDA NDA019696 B. Braun Medical Inc. MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC .03; .037; .00082; .37; .53; .5; .012 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0264-7730_8b4ab42b-a486-45b6-8ab9-4d2ba5bfa683 0264-7730 HUMAN PRESCRIPTION DRUG Isolyte P in Dextrose Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, and Potassium Phosphate, Dibasic INJECTION, SOLUTION INTRAVENOUS 19930610 NDA NDA019873 B. Braun Medical Inc. DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE 5; .031; .13; .026; .32 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7750_5b78768f-c7eb-4bd7-a4f7-91ebfbd91273 0264-7750 HUMAN PRESCRIPTION DRUG Lactated Ringers Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride INJECTION, SOLUTION INTRAVENOUS 19880229 NDA NDA019632 B. Braun Medical Inc. CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE .02; .03; .6; .31 g/100mL; g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0264-7751_18607458-76ca-4880-86ad-f67e12fa799a 0264-7751 HUMAN PRESCRIPTION DRUG Dextrose in Lactated Ringers DEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019634 B. Braun Medical Inc. CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE .02; 5; .03; .6; .31 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0264-7780_3e706e97-36da-4886-b44a-8c23ce2e8c0d 0264-7780 HUMAN PRESCRIPTION DRUG Ringers Sodium Chloride, Calcium Chloride, and Potassium Chloride INJECTION, SOLUTION INTRAVENOUS 19920417 NDA NDA020002 B. Braun Medical Inc. CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE .033; .03; .86 g/100mL; g/100mL; g/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0264-7800_cea3edff-550a-4a4b-a213-65bcd67832ea 0264-7800 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20131231 NDA NDA019635 B. Braun Medical Inc. SODIUM CHLORIDE .9 g/100mL 0264-7800_f05047f1-6df2-4aad-836b-cbab5e06fcae 0264-7800 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880309 NDA NDA019635 B. Braun Medical Inc. SODIUM CHLORIDE .9 g/100mL 0264-7802_f05047f1-6df2-4aad-836b-cbab5e06fcae 0264-7802 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880309 NDA NDA019635 B. Braun Medical Inc. SODIUM CHLORIDE .45 g/100mL 0264-7805_04ae0ef0-80a1-457d-a7a7-6108de0c2690 0264-7805 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19880319 NDA NDA019635 B. Braun Medical Inc. SODIUM CHLORIDE 3 g/100mL 0264-7806_04ae0ef0-80a1-457d-a7a7-6108de0c2690 0264-7806 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19880309 NDA NDA019635 B. Braun Medical Inc. SODIUM CHLORIDE 5 g/100mL 0264-7850_14c1ad78-1ea2-4c5e-9f08-e87be8a852e6 0264-7850 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION INTRAVENOUS 19880224 NDA NDA019633 B. Braun Medical Inc. WATER 1 mL/mL 0264-7865_4623a0b4-8a80-498a-8341-8b3be7b496c0 0264-7865 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE IN SODIUM CHLORIDE SODIUM CHLORIDE and POTASSIUM CHLORIDE SOLUTION INTRAVENOUS 19890929 NDA NDA019708 B. Braun Medical Inc. POTASSIUM CHLORIDE; SODIUM CHLORIDE .15; .9 g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-7885_4623a0b4-8a80-498a-8341-8b3be7b496c0 0264-7885 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE IN SODIUM CHLORIDE SODIUM CHLORIDE and POTASSIUM CHLORIDE SOLUTION INTRAVENOUS 19890929 NDA NDA019708 B. Braun Medical Inc. POTASSIUM CHLORIDE; SODIUM CHLORIDE .3; .9 g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0264-8612_c04b2b6e-1162-4011-a351-a5b95af57643 0264-8612 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride Dextrose and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20140131 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 5; .45 g/100mL; g/100mL 0264-9010_a7532439-29ef-433d-8505-c0a8bbfd549b 0264-9010 HUMAN PRESCRIPTION DRUG FreAmine III ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, GLYCINE, CYSTEINE, PHOSPHORIC ACID, and SODIUM BISULFITE INJECTION, SOLUTION INTRAVENOUS 19710924 NDA NDA016822 B. Braun Medical Inc. ALANINE; ARGININE; CYSTEINE HYDROCHLORIDE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE .71; .95; .016; 1.4; .28; .69; .91; .73; .53; .56; .12; 1.12; .59; .4; .15; .66 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0264-9341_e116b93b-0b11-405d-a179-8e6ddb133c9b 0264-9341 HUMAN PRESCRIPTION DRUG TrophAmine ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE SOLUTION INTRAVENOUS 19840720 NDA NDA019018 B. Braun Medical Inc. ALANINE; ARGININE; ASPARTIC ACID; CYSTEINE HYDROCHLORIDE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; N-ACETYLTYROSINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE .54; 1.2; .32; .024; .5; .36; .48; .82; 1.4; 1.2; .34; .24; .48; .68; .38; .025; .42; .2; .044; .78 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0264-9350_6ec6a7cd-2af3-4a8f-b727-755c02cd2f88 0264-9350 HUMAN PRESCRIPTION DRUG FreAmine HBC ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, GLYCINE, CYSTEINE, and SODIUM BISULFITE INJECTION, SOLUTION INTRAVENOUS 19710924 NDA NDA016822 B. Braun Medical Inc. ALANINE; ARGININE; CYSTEINE HYDROCHLORIDE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE .4; .58; .014; .33; .16; .76; 1.37; .41; .25; .32; .63; .33; .2; .09; .88 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0264-9361_e116b93b-0b11-405d-a179-8e6ddb133c9b 0264-9361 HUMAN PRESCRIPTION DRUG TrophAmine ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE SOLUTION INTRAVENOUS 19840720 NDA NDA019018 B. Braun Medical Inc. ALANINE; ARGININE; ASPARTIC ACID; CYSTEINE HYDROCHLORIDE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; N-ACETYLTYROSINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE .32; .73; .19; .02; .3; .22; .29; .49; .84; .69; .2; .12; .29; .41; .23; .015; .25; .12; .044; .47 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0264-9371_d026d29b-2206-4be0-8fc6-135fa90effc8 0264-9371 HUMAN PRESCRIPTION DRUG HepatAmine isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alani INJECTION, SOLUTION INTRAVENOUS 19820803 NDA NDA018676 B. Braun Medical Inc. ALANINE; ARGININE; CYSTEINE HYDROCHLORIDE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE .77; .6; .014; .9; .24; .9; 1.1; .61; .1; .1; .115; .8; .5; .45; .066; .84 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0264-9554_60468a47-bce1-442a-8375-6c45e251c914 0264-9554 HUMAN PRESCRIPTION DRUG Theophylline in Dextrose Theophylline Anhydrous and Dextrose INJECTION, SOLUTION INTRAVENOUS 19920814 NDA NDA019826 B. Braun Medical Inc. DEXTROSE MONOHYDRATE; THEOPHYLLINE ANHYDROUS 5; 80 g/100mL; mg/100mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0264-9558_60468a47-bce1-442a-8375-6c45e251c914 0264-9558 HUMAN PRESCRIPTION DRUG Theophylline in Dextrose Theophylline Anhydrous and Dextrose INJECTION, SOLUTION INTRAVENOUS 19920814 NDA NDA019826 B. Braun Medical Inc. DEXTROSE MONOHYDRATE; THEOPHYLLINE ANHYDROUS 5; 160 g/100mL; mg/100mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0264-9567_f16aa82e-b964-4e45-a7b9-5c22ffa9cdab 0264-9567 HUMAN PRESCRIPTION DRUG Heparin Sodium in Dextrose Heparin Sodium and Dextrose INJECTION INTRAVENOUS 19920720 NDA NDA019952 B. Braun Medical Inc. DEXTROSE MONOHYDRATE; HEPARIN SODIUM 5; 4000 g/100mL; [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0264-9577_f16aa82e-b964-4e45-a7b9-5c22ffa9cdab 0264-9577 HUMAN PRESCRIPTION DRUG Heparin Sodium in Dextrose Heparin Sodium and Dextrose INJECTION INTRAVENOUS 19920720 NDA NDA019952 B. Braun Medical Inc. DEXTROSE MONOHYDRATE; HEPARIN SODIUM 5; 5000 g/100mL; [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0264-9587_f16aa82e-b964-4e45-a7b9-5c22ffa9cdab 0264-9587 HUMAN PRESCRIPTION DRUG Heparin Sodium in Dextrose Heparin Sodium and Dextrose INJECTION INTRAVENOUS 19920720 NDA NDA019952 B. Braun Medical Inc. DEXTROSE MONOHYDRATE; HEPARIN SODIUM 5; 10000 g/100mL; [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0264-9594_0f66be0e-6920-4499-b35f-4f576bbbaaaf 0264-9594 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Dextrose LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19920408 NDA NDA019830 B. Braun Medical Inc. DEXTROSE MONOHYDRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 5; .4 g/100mL; g/100mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0264-9598_0f66be0e-6920-4499-b35f-4f576bbbaaaf 0264-9598 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Dextrose LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19920408 NDA NDA019830 B. Braun Medical Inc. DEXTROSE MONOHYDRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 5; .8 g/100mL; g/100mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0264-9872_9926fb9b-384a-463b-8a13-2aadb9e1cfb2 0264-9872 HUMAN PRESCRIPTION DRUG Heparin Sodium in Sodium Chloride Heparin Sodium in Sodium Chloride INJECTION INTRAVENOUS 19920720 NDA NDA019953 B. Braun Medical Inc. HEPARIN SODIUM 200 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0264-9999_5e0c9906-685c-4032-9a14-7a0c42480482 0264-9999 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAVENOUS 20140819 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE B. Braun Medical Inc. SODIUM CHLORIDE 450 mg/500mL 0268-0001_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0001 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 1000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0002_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0002 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 10000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0003_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0003 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 10000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0004_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0004 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 20000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0005_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0005 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 40000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0006_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0006 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 10 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0007_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0007 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 100 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0008_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0008 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 500 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0009_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0009 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST .1 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0010_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0010 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 10000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0011_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0011 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 20000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0012_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0012 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST .1 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0013_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0013 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST .05 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0021_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0021 HUMAN PRESCRIPTION DRUG CENTER-AL - ACACIA LONGIFOLIA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ACACIA LONGIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0024_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0024 HUMAN PRESCRIPTION DRUG CENTER-AL - ALNUS INCANA SSP. RUGOSA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ALNUS INCANA SSP. RUGOSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0027_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0027 HUMAN PRESCRIPTION DRUG CENTER-AL - FRAXINUS AMERICANA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0030_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0030 HUMAN PRESCRIPTION DRUG CENTER-AL - PASPALUM NOTATUM POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0031_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0031 HUMAN PRESCRIPTION DRUG CENTER-AL - PASPALUM NOTATUM POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0034_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0034 HUMAN PRESCRIPTION DRUG CENTER-AL - FAGUS GRANDIFOLIA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. FAGUS GRANDIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0037_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0037 HUMAN PRESCRIPTION DRUG CENTER-AL - CYNODON DACTYLON POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. CYNODON DACTYLON POLLEN 10000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0038_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0038 HUMAN PRESCRIPTION DRUG CENTER-AL - CYNODON DACTYLON POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. CYNODON DACTYLON POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0041_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0041 HUMAN PRESCRIPTION DRUG CENTER-AL - BETULA LENTA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0044_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0044 HUMAN PRESCRIPTION DRUG CENTER-AL - POA ANNUA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. POA ANNUA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0047_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0047 HUMAN PRESCRIPTION DRUG CENTER-AL - ACER NEGUNDO POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ACER NEGUNDO POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0050_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0050 HUMAN PRESCRIPTION DRUG CENTER-AL - BROMUS INERMIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. BROMUS INERMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0053_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0053 HUMAN PRESCRIPTION DRUG CENTER-AL - XANTHIUM STRUMARIUM POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0054_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0054 HUMAN PRESCRIPTION DRUG CENTER-AL - XANTHIUM STRUMARIUM POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM POLLEN 5000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0057_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0057 HUMAN PRESCRIPTION DRUG CENTER-AL - ZEA MAYS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ZEA MAYS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0060_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0060 HUMAN PRESCRIPTION DRUG CENTER-AL - POPULUS DELTOIDES SSP. MONILIFERA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES SSP. MONILIFERA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0063_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0063 HUMAN PRESCRIPTION DRUG CENTER-AL - RUMEX ACETOSELLA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 0268-0066_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0066 HUMAN PRESCRIPTION DRUG CENTER-AL - RUMEX CRISPUS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. RUMEX CRISPUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0069_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0069 HUMAN PRESCRIPTION DRUG CENTER-AL - ULMUS AMERICANA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0072_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0072 HUMAN PRESCRIPTION DRUG CENTER-AL - ULMUS PUMILA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ULMUS PUMILA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0075_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0075 HUMAN PRESCRIPTION DRUG CENTER-AL - CORYLUS AMERICANA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. CORYLUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0078_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0078 HUMAN PRESCRIPTION DRUG CENTER-AL - CARYA OVATA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. CARYA OVATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0081_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0081 HUMAN PRESCRIPTION DRUG CENTER-AL - HOUSE DUST Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 10000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0082_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0082 HUMAN PRESCRIPTION DRUG CENTER-AL - HOUSE DUST Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 1000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0083_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0083 HUMAN PRESCRIPTION DRUG CENTER-AL - HOUSE DUST Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 10 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0084_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0084 HUMAN PRESCRIPTION DRUG CENTER-AL - HOUSE DUST Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 100 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-0087_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0087 HUMAN PRESCRIPTION DRUG CENTER-AL - SORGHUM HALEPENSE POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0090_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0090 HUMAN PRESCRIPTION DRUG CENTER-AL - POA PRATENSIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. POA PRATENSIS POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0091_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0091 HUMAN PRESCRIPTION DRUG CENTER-AL - POA PRATENSIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. POA PRATENSIS POLLEN 10000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0094_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0094 HUMAN PRESCRIPTION DRUG CENTER-AL - KOCHIA SCOPARIA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. KOCHIA SCOPARIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0097_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0097 HUMAN PRESCRIPTION DRUG CENTER-AL - CHENOPODIUM ALBUM POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0100_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0100 HUMAN PRESCRIPTION DRUG CENTER-AL - ACER SACCHARUM POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ACER SACCHARUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0103_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0103 HUMAN PRESCRIPTION DRUG CENTER-AL - FESTUCA PRATENSIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. FESTUCA PRATENSIS POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0104_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0104 HUMAN PRESCRIPTION DRUG CENTER-AL - FESTUCA PRATENSIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. FESTUCA PRATENSIS POLLEN 10000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0107_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0107 HUMAN PRESCRIPTION DRUG CENTER-AL - PROSOPIS JULIFLORA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PROSOPIS JULIFLORA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0110_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0110 HUMAN PRESCRIPTION DRUG CENTER-AL - ARTEMISIA VULGARIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA VULGARIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0113_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0113 HUMAN PRESCRIPTION DRUG CENTER-AL - MORUS RUBRA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. MORUS RUBRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0116_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0116 HUMAN PRESCRIPTION DRUG CENTER-AL - QUERCUS AGRIFOLIA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. QUERCUS AGRIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0119_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0119 HUMAN PRESCRIPTION DRUG CENTER-AL - QUERCUS VIRGINIANA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. QUERCUS VIRGINIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0122_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0122 HUMAN PRESCRIPTION DRUG CENTER-AL - QUERCUS ALBA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0125_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0125 HUMAN PRESCRIPTION DRUG CENTER-AL - AVENA SATIVA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AVENA SATIVA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0128_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0128 HUMAN PRESCRIPTION DRUG CENTER-AL - OLEA EUROPAEA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. OLEA EUROPAEA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0129_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0129 HUMAN PRESCRIPTION DRUG CENTER-AL - OLEA EUROPAEA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. OLEA EUROPAEA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0130_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0130 HUMAN PRESCRIPTION DRUG CENTER-AL - OLEA EUROPAEA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. OLEA EUROPAEA POLLEN 10 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0131_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0131 HUMAN PRESCRIPTION DRUG CENTER-AL - OLEA EUROPAEA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. OLEA EUROPAEA POLLEN 100 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0134_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0134 HUMAN PRESCRIPTION DRUG CENTER-AL - DACTYLIS GLOMERATA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. DACTYLIS GLOMERATA POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0137_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0137 HUMAN PRESCRIPTION DRUG CENTER-AL - CARYA ILLINOINENSIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0140_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0140 HUMAN PRESCRIPTION DRUG CENTER-AL - AMARANTHUS RETROFLEXUS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0141_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0141 HUMAN PRESCRIPTION DRUG CENTER-AL - AMARANTHUS RETROFLEXUS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN 5000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0144_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0144 HUMAN PRESCRIPTION DRUG CENTER-AL - PLANTAGO LANCEOLATA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0145_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0145 HUMAN PRESCRIPTION DRUG CENTER-AL - PLANTAGO LANCEOLATA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 100 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0146_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0146 HUMAN PRESCRIPTION DRUG CENTER-AL - PLANTAGO LANCEOLATA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0147_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0147 HUMAN PRESCRIPTION DRUG CENTER-AL - PLANTAGO LANCEOLATA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 10 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0150_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0150 HUMAN PRESCRIPTION DRUG CENTER-AL - POPULUS ALBA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. POPULUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0153_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0153 HUMAN PRESCRIPTION DRUG CENTER-AL - AMBROSIA ACANTHICARPA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ACANTHICARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0156_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0156 HUMAN PRESCRIPTION DRUG CENTER-AL - AMBROSIA ACANTHICARPA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0157_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0157 HUMAN PRESCRIPTION DRUG CENTER-AL - AMBROSIA ACANTHICARPA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 10000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0160_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0160 HUMAN PRESCRIPTION DRUG CENTER-AL - AMBROSIA TRIFIDA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TRIFIDA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0161_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0161 HUMAN PRESCRIPTION DRUG CENTER-AL - AMBROSIA TRIFIDA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TRIFIDA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0164_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0164 HUMAN PRESCRIPTION DRUG CENTER-AL - AMBROSIA PSILOSTACHYA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMBROSIA PSILOSTACHYA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0167_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0167 HUMAN PRESCRIPTION DRUG CENTER-AL - AGROSTIS GIGANTEA Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AGROSTIS GIGANTEA 20000 [PNU]/mL 0268-0170_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0170 HUMAN PRESCRIPTION DRUG CENTER-AL - SALSOLA KALI POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. SALSOLA KALI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0173_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0173 HUMAN PRESCRIPTION DRUG CENTER-AL - LOLIUM PERENNE POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. LOLIUM PERENNE POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0174_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0174 HUMAN PRESCRIPTION DRUG CENTER-AL - LOLIUM PERENNE POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. LOLIUM PERENNE POLLEN 10000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0177_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0177 HUMAN PRESCRIPTION DRUG CENTER-AL - ARTEMISIA TRIDENTATA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA TRIDENTATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0180_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0180 HUMAN PRESCRIPTION DRUG CENTER-AL - ATRIPLEX WRIGHTII POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ATRIPLEX WRIGHTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0183_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0183 HUMAN PRESCRIPTION DRUG CENTER-AL - ATRIPLEX WRIGHTII POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ATRIPLEX WRIGHTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0186_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0186 HUMAN PRESCRIPTION DRUG CENTER-AL - PLATANUS OCCIDENTALIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PLATANUS OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0189_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0189 HUMAN PRESCRIPTION DRUG CENTER-AL - PLATANUS RACEMOSA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PLATANUS RACEMOSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0192_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0192 HUMAN PRESCRIPTION DRUG CENTER-AL - PHLEUM PRATENSE POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN 10000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0193_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0193 HUMAN PRESCRIPTION DRUG CENTER-AL - PHLEUM PRATENSE POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0196_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0196 HUMAN PRESCRIPTION DRUG CENTER-AL - HOLCUS LANATUS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. HOLCUS LANATUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0199_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0199 HUMAN PRESCRIPTION DRUG CENTER-AL - JUGLANS NIGRA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0202_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0202 HUMAN PRESCRIPTION DRUG CENTER-AL - JUGLANS CALIFORNICA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. JUGLANS CALIFORNICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0205_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-0205 HUMAN PRESCRIPTION DRUG CENTER-AL - SALIX NIGRA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0247_28517fe7-35ea-4ed9-af4c-2800c890460e 0268-0247 HUMAN PRESCRIPTION DRUG Histamine Positive Skin Test Control histamine phosphate SOLUTION PERCUTANEOUS 19891023 BLA BLA103754 ALK-Abello, Inc. HISTAMINE PHOSPHATE 2.75 mg/mL 0268-0248_28517fe7-35ea-4ed9-af4c-2800c890460e 0268-0248 HUMAN PRESCRIPTION DRUG histamine positive skin test control histamine phosphate INJECTION, SOLUTION SUBCUTANEOUS 19891023 BLA BLA103754 ALK-Abello, Inc. HISTAMINE PHOSPHATE .275 mg/mL 0268-0268_55746080-edfc-4d38-9d49-85a4329bbd2c 0268-0268 HUMAN PRESCRIPTION DRUG Cat Pelt, Standardized Cat Pelt, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19920924 BLA BLA103061 ALK-Abello, Inc. FELIS CATUS SKIN 10000 [BAU]/mL Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0269_55746080-edfc-4d38-9d49-85a4329bbd2c 0268-0269 HUMAN PRESCRIPTION DRUG Cat Pelt, Standardized Cat Pelt, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19920924 BLA BLA103061 ALK-Abello, Inc. FELIS CATUS SKIN 100 [BAU]/mL Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0274_55746080-edfc-4d38-9d49-85a4329bbd2c 0268-0274 HUMAN PRESCRIPTION DRUG Cat Pelt, Standardized Cat Pelt, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19920924 BLA BLA103061 ALK-Abello, Inc. FELIS CATUS SKIN 5000 [BAU]/mL Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0275_0fbc190d-80b9-4c94-b8dc-637ae1c75366 0268-0275 HUMAN PRESCRIPTION DRUG Standardized Mite D. farinae Standardized Mite D. farinae INJECTION, SOLUTION SUBCUTANEOUS 19910708 BLA BLA103060 ALK-Abello, Inc. DERMATOPHAGOIDES FARINAE 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0276_0fbc190d-80b9-4c94-b8dc-637ae1c75366 0268-0276 HUMAN PRESCRIPTION DRUG Standardized Mite D. farinae Standardized Mite D. farinae INJECTION, SOLUTION SUBCUTANEOUS 19910708 BLA BLA103060 ALK-Abello, Inc. DERMATOPHAGOIDES FARINAE 5000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0277_0fbc190d-80b9-4c94-b8dc-637ae1c75366 0268-0277 HUMAN PRESCRIPTION DRUG Standardized Mite D. pteronyssinus Standardized Mite D. pteronyssinus INJECTION, SOLUTION SUBCUTANEOUS 19900814 BLA BLA103752 ALK-Abello, Inc. DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0278_0fbc190d-80b9-4c94-b8dc-637ae1c75366 0268-0278 HUMAN PRESCRIPTION DRUG Standardized Mite D. pteronyssinus Standardized Mite D. pteronyssinus INJECTION, SOLUTION SUBCUTANEOUS 19900814 BLA BLA103752 ALK-Abello, Inc. DERMATOPHAGOIDES PTERONYSSINUS 5000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0279_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0279 HUMAN PRESCRIPTION DRUG Timothy, Standardized Timothy, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103058 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0280_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0280 HUMAN PRESCRIPTION DRUG Timothy, Standardized Timothy, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103058 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0281_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0281 HUMAN PRESCRIPTION DRUG Orchard Grass, Standardized Orchard Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103054 ALK-Abello, Inc. ALLERGENIC EXTRACT- ORCHARD GRASS DACTYLIS GLOMERATA 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0282_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0282 HUMAN PRESCRIPTION DRUG Orchard Grass, Standardized Orchard Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103054 ALK-Abello, Inc. ALLERGENIC EXTRACT- ORCHARD GRASS DACTYLIS GLOMERATA 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0283_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0283 HUMAN PRESCRIPTION DRUG Kentucky Bluegrass (June), Standardized Kentucky Bluegrass (June), Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103052 ALK-Abello, Inc. POA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0284_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0284 HUMAN PRESCRIPTION DRUG Kentucky Bluegrass (June), Standardized Kentucky Bluegrass (June), Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103052 ALK-Abello, Inc. POA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0285_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0285 HUMAN PRESCRIPTION DRUG Redtop Grass, Standardized Redtop Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103055 ALK-Abello, Inc. AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0286_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0286 HUMAN PRESCRIPTION DRUG Redtop Grass, Standardized Redtop Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103055 ALK-Abello, Inc. AGROSTIS GIGANTEA POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0287_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0287 HUMAN PRESCRIPTION DRUG Sweet Vernal Grass, Standardized Sweet Vernal Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103057 ALK-Abello, Inc. ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0288_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0288 HUMAN PRESCRIPTION DRUG Sweet Vernal Grass, Standardized Sweet Vernal Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103057 ALK-Abello, Inc. ANTHOXANTHUM ODORATUM POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0289_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0289 HUMAN PRESCRIPTION DRUG Rye Grass, Perennial Standardized Rye Grass, Perennial Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103056 ALK-Abello, Inc. ALLERGENIC EXTRACT- RYEGRASS, PERENNIAL LOLIUM PERENNE 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0290_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0290 HUMAN PRESCRIPTION DRUG Rye Grass, Perennial Standardized Rye Grass, Perennial Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103056 ALK-Abello, Inc. ALLERGENIC EXTRACT- RYEGRASS, PERENNIAL LOLIUM PERENNE 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0291_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0291 HUMAN PRESCRIPTION DRUG Meadow Fescue Grass, Standardized Meadow Fescue Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103053 ALK-Abello, Inc. FESTUCA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0292_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0292 HUMAN PRESCRIPTION DRUG Meadow Fescue Grass, Standardized Meadow Fescue Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103053 ALK-Abello, Inc. FESTUCA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0293_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0293 HUMAN PRESCRIPTION DRUG Bermuda Grass, Standardized Bermuda Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103051 ALK-Abello, Inc. CYNODON DACTYLON POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0603_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0603 NON-STANDARDIZED ALLERGENIC BOS TAURUS SKIN CATTLE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOS TAURUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0604_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0604 NON-STANDARDIZED ALLERGENIC BOS TAURUS SKIN CATTLE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOS TAURUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0605_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0605 NON-STANDARDIZED ALLERGENIC BOS TAURUS SKIN CATTLE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOS TAURUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0606_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0606 NON-STANDARDIZED ALLERGENIC BOS TAURUS SKIN CATTLE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOS TAURUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0609_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0609 NON-STANDARDIZED ALLERGENIC COTTON FIBER COTTON LINTERS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COTTON FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0612_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0612 NON-STANDARDIZED ALLERGENIC COTTON SEED COTTONSEED INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COTTON SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 0268-0615_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0615 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0616_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0616 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN 1000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0617_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0617 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN 10 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0618_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0618 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN 100 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0619_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0619 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0620_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0620 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0621_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0621 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .05 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0622_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0622 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .005 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0623_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0623 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .0005 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0624_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0624 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .001 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0625_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0625 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .01 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0626_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0626 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0627_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0627 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0628_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0628 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN HORSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0629_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0629 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN HORSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0630_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0630 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN HORSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0631_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0631 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN HORSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0632_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0632 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN HORSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN 100 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0635_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0635 NON-STANDARDIZED ALLERGENIC CEIBA PENTANDRA FIBER KAPOK INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CEIBA PENTANDRA FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0638_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0638 NON-STANDARDIZED ALLERGENIC MUS MUSCULUS SKIN MOUSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUS MUSCULUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0639_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0639 NON-STANDARDIZED ALLERGENIC MUS MUSCULUS SKIN MOUSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUS MUSCULUS SKIN 100 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0642_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0642 NON-STANDARDIZED ALLERGENIC ORRIS ORRIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ORRIS .05 g/mL 0268-0645_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0645 NON-STANDARDIZED ALLERGENIC PYRETHRUM CINERARIIFOLIUM PYRETHRUM CINERARIIFOLIUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PYRETHRUM CINERARIIFOLIUM .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 0268-0646_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0646 NON-STANDARDIZED ALLERGENIC PYRETHRUM CINERARIIFOLIUM PYRETHRUM CINERARIIFOLIUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PYRETHRUM CINERARIIFOLIUM .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 0268-0649_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0649 NON-STANDARDIZED ALLERGENIC RABBIT RABBIT INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RABBIT 10000 [PNU]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 0268-0650_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0650 NON-STANDARDIZED ALLERGENIC RABBIT RABBIT INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RABBIT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 0268-0651_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0651 NON-STANDARDIZED ALLERGENIC RABBIT RABBIT INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RABBIT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 0268-0652_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0652 NON-STANDARDIZED ALLERGENIC RABBIT RABBIT INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RABBIT 20000 [PNU]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 0268-0653_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0653 NON-STANDARDIZED ALLERGENIC CAVIA PORCELLUS SKIN GUINEA PIG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CAVIA PORCELLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0654_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0654 NON-STANDARDIZED ALLERGENIC CAVIA PORCELLUS SKIN GUINEA PIG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CAVIA PORCELLUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0655_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0655 NON-STANDARDIZED ALLERGENIC CAVIA PORCELLUS SKIN GUINEA PIG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CAVIA PORCELLUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0656_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0656 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN HORSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0705_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0705 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA AMERICAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0706_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0706 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA AMERICAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0707_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0707 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA AMERICAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0708_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0708 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA AMERICAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA 1000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0709_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0709 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA AMERICAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA 10 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0710_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0710 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA AMERICAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA 100 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0711_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0711 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA AMERICAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA .001 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0714_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0714 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0715_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0715 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA 1000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0716_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0716 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA 10 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0717_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0717 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA 100 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0718_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0718 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0719_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0719 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0720_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0720 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA .001 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0721_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0721 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA 500 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0800_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0800 NON-STANDARDIZED ALLERGENIC ACREMONIUM STRICTUM ACREMONIUM STRICTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACREMONIUM STRICTUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0801_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0801 NON-STANDARDIZED ALLERGENIC ACREMONIUM STRICTUM ACREMONIUM STRICTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACREMONIUM STRICTUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0802_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0802 NON-STANDARDIZED ALLERGENIC ACREMONIUM STRICTUM ACREMONIUM STRICTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACREMONIUM STRICTUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0803_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0803 NON-STANDARDIZED ALLERGENIC ACREMONIUM STRICTUM ACREMONIUM STRICTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACREMONIUM STRICTUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0805_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0805 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0806_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0806 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 100 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0807_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0807 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0808_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0808 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0809_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0809 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0810_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0810 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 10 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0811_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0811 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA .01 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0812_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0812 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0813_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0813 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA .02 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0814_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0814 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 100 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0815_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0815 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0816_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0816 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0817_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0817 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0818_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0818 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0819_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0819 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0820_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0820 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0821_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0821 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 10 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0822_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0822 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 100 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0823_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0823 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS .02 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0824_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0824 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0825_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0825 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0826_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0826 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0827_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0827 NON-STANDARDIZED ALLERGENIC ASPERGILLUS NIGER VAR NIGER ASPERGILLUS NIGER INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS NIGER VAR. NIGER 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0828_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0828 NON-STANDARDIZED ALLERGENIC ASPERGILLUS NIGER VAR NIGER ASPERGILLUS NIGER INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS NIGER VAR. NIGER 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0829_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0829 NON-STANDARDIZED ALLERGENIC ASPERGILLUS NIGER VAR NIGER ASPERGILLUS NIGER INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS NIGER VAR. NIGER 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0830_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0830 NON-STANDARDIZED ALLERGENIC ASPERGILLUS NIGER VAR NIGER ASPERGILLUS NIGER INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS NIGER VAR. NIGER 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0832_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0832 NON-STANDARDIZED ALLERGENIC AUREOBASIDIUM PULLULANS VAR PULLULANS PULLULARIA PULLULANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0833_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0833 NON-STANDARDIZED ALLERGENIC AUREOBASIDIUM PULLULANS VAR PULLULANS PULLULARIA PULLULANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0834_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0834 NON-STANDARDIZED ALLERGENIC AUREOBASIDIUM PULLULANS VAR PULLULANS PULLULARIA PULLULANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0835_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0835 NON-STANDARDIZED ALLERGENIC AUREOBASIDIUM PULLULANS VAR PULLULANS PULLULARIA PULLULANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0836_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0836 NON-STANDARDIZED ALLERGENIC AUREOBASIDIUM PULLULANS VAR PULLULANS PULLULARIA PULLULANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0837_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0837 NON-STANDARDIZED ALLERGENIC BOTRYTIS CINEREA BOTRYTIS CINEREA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOTRYTIS CINEREA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0838_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0838 NON-STANDARDIZED ALLERGENIC BOTRYTIS CINEREA BOTRYTIS CINEREA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOTRYTIS CINEREA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0839_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0839 NON-STANDARDIZED ALLERGENIC BOTRYTIS CINEREA BOTRYTIS CINEREA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOTRYTIS CINEREA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0840_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0840 NON-STANDARDIZED ALLERGENIC BOTRYTIS CINEREA BOTRYTIS CINEREA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOTRYTIS CINEREA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0841_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0841 NON-STANDARDIZED ALLERGENIC BOTRYTIS CINEREA BOTRYTIS CINEREA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOTRYTIS CINEREA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0842_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0842 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS .01 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 0268-0843_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0843 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS 20000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 0268-0844_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0844 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS 10000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 0268-0845_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0845 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS 40000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 0268-0846_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0846 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS 1000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 0268-0847_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0847 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS 100 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 0268-0848_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0848 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS .02 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 0268-0849_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0849 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS 20000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 0268-0850_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0850 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS 10000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 0268-0851_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0851 NON-STANDARDIZED ALLERGENIC CHAETOMIUM GLOBOSUM CHAETOMIUM GLOBOSUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHAETOMIUM GLOBOSUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0852_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0852 NON-STANDARDIZED ALLERGENIC CHAETOMIUM GLOBOSUM CHAETOMIUM GLOBOSUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHAETOMIUM GLOBOSUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0853_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0853 NON-STANDARDIZED ALLERGENIC CHAETOMIUM GLOBOSUM CHAETOMIUM GLOBOSUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHAETOMIUM GLOBOSUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0855_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0855 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0856_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0856 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0857_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0857 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0858_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0858 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES 100 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0859_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0859 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES .01 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0860_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0860 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0861_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0861 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0863_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0863 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0864_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0864 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0865_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0865 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0866_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0866 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0867_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0867 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 10 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0868_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0868 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 100 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0869_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0869 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0870_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0870 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0871_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0871 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0878_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0878 NON-STANDARDIZED ALLERGENIC COCHLIOBOLUS SATIVUS HELMINTHOSPORIUM SOROKINIANUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0879_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0879 NON-STANDARDIZED ALLERGENIC COCHLIOBOLUS SATIVUS HELMINTHOSPORIUM SOROKINIANUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0880_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0880 NON-STANDARDIZED ALLERGENIC COCHLIOBOLUS SATIVUS HELMINTHOSPORIUM SOROKINIANUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0881_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0881 NON-STANDARDIZED ALLERGENIC COCHLIOBOLUS SATIVUS HELMINTHOSPORIUM SOROKINIANUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0882_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0882 NON-STANDARDIZED ALLERGENIC COCHLIOBOLUS SATIVUS HELMINTHOSPORIUM SOROKINIANUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0883_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0883 NON-STANDARDIZED ALLERGENIC COCHLIOBOLUS SATIVUS HELMINTHOSPORIUM SOROKINIANUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0884_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0884 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 20000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 0268-0885_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0885 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 10000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 0268-0886_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0886 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 40000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 0268-0887_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0887 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 1000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 0268-0888_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0888 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 10 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 0268-0889_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0889 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 100 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 0268-0890_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0890 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM .025 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 0268-0891_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0891 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM .001 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 0268-0892_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0892 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 20000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 0268-0893_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0893 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 10000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 0268-0894_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0894 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0895_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0895 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0896_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0896 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0897_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0897 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0898_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0898 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 10 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0899_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0899 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 100 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0900_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0900 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0901_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0901 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0902_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0902 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0903_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0903 NON-STANDARDIZED ALLERGENIC HELMINTHOSPORIUM SOLANI HELMINTHOSPORIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HELMINTHOSPORIUM SOLANI 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0904_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0904 NON-STANDARDIZED ALLERGENIC HELMINTHOSPORIUM SOLANI HELMINTHOSPORIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HELMINTHOSPORIUM SOLANI 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0905_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0905 NON-STANDARDIZED ALLERGENIC HELMINTHOSPORIUM SOLANI HELMINTHOSPORIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HELMINTHOSPORIUM SOLANI 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0906_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0906 NON-STANDARDIZED ALLERGENIC HELMINTHOSPORIUM SOLANI HELMINTHOSPORIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HELMINTHOSPORIUM SOLANI 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0911_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0911 NON-STANDARDIZED ALLERGENIC MUCOR PLUMBEUS MUCOR PLUMBEUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUCOR PLUMBEUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0912_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0912 NON-STANDARDIZED ALLERGENIC MUCOR PLUMBEUS MUCOR PLUMBEUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUCOR PLUMBEUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0913_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0913 NON-STANDARDIZED ALLERGENIC MUCOR PLUMBEUS MUCOR PLUMBEUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUCOR PLUMBEUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0914_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0914 NON-STANDARDIZED ALLERGENIC MUCOR PLUMBEUS MUCOR PLUMBEUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUCOR PLUMBEUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0915_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0915 NON-STANDARDIZED ALLERGENIC MUCOR PLUMBEUS MUCOR PLUMBEUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUCOR PLUMBEUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0916_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0916 NON-STANDARDIZED ALLERGENIC NEUROSPORA INTERMEDIA NEUROSPORA INTERMEDIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. NEUROSPORA INTERMEDIA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0917_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0917 NON-STANDARDIZED ALLERGENIC NEUROSPORA INTERMEDIA NEUROSPORA INTERMEDIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. NEUROSPORA INTERMEDIA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0918_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0918 NON-STANDARDIZED ALLERGENIC NEUROSPORA INTERMEDIA NEUROSPORA INTERMEDIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. NEUROSPORA INTERMEDIA .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0919_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0919 NON-STANDARDIZED ALLERGENIC NEUROSPORA INTERMEDIA NEUROSPORA INTERMEDIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. NEUROSPORA INTERMEDIA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0920_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0920 NON-STANDARDIZED ALLERGENIC NEUROSPORA INTERMEDIA NEUROSPORA INTERMEDIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. NEUROSPORA INTERMEDIA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0921_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0921 NON-STANDARDIZED ALLERGENIC PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM PENICILLIUM CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0922_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0922 NON-STANDARDIZED ALLERGENIC PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM PENICILLIUM CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0923_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0923 NON-STANDARDIZED ALLERGENIC PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM PENICILLIUM CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0924_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0924 NON-STANDARDIZED ALLERGENIC PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM PENICILLIUM CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 100 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0925_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0925 NON-STANDARDIZED ALLERGENIC PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM PENICILLIUM CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0926_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0926 NON-STANDARDIZED ALLERGENIC PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM PENICILLIUM CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0928_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0928 NON-STANDARDIZED ALLERGENIC PHOMA EXIGUA VAR EXIGUA PHOMA HERBARUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PHOMA EXIGUA VAR. EXIGUA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0929_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0929 NON-STANDARDIZED ALLERGENIC PHOMA EXIGUA VAR EXIGUA PHOMA HERBARUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PHOMA EXIGUA VAR. EXIGUA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0930_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0930 NON-STANDARDIZED ALLERGENIC PHOMA EXIGUA VAR EXIGUA PHOMA HERBARUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PHOMA EXIGUA VAR. EXIGUA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0931_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0931 NON-STANDARDIZED ALLERGENIC PHOMA EXIGUA VAR EXIGUA PHOMA HERBARUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PHOMA EXIGUA VAR. EXIGUA .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0932_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0932 NON-STANDARDIZED ALLERGENIC PHOMA EXIGUA VAR EXIGUA PHOMA HERBARUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PHOMA EXIGUA VAR. EXIGUA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0933_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0933 NON-STANDARDIZED ALLERGENIC PHOMA EXIGUA VAR EXIGUA PHOMA HERBARUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PHOMA EXIGUA VAR. EXIGUA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0934_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0934 NON-STANDARDIZED ALLERGENIC RHIZOPUS ARRHIZUS VAR ARRHIZUS RHIZOPUS BATATAS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0935_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0935 NON-STANDARDIZED ALLERGENIC RHIZOPUS ARRHIZUS VAR ARRHIZUS RHIZOPUS BATATAS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0936_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0936 NON-STANDARDIZED ALLERGENIC RHIZOPUS ARRHIZUS VAR ARRHIZUS RHIZOPUS BATATAS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0937_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0937 NON-STANDARDIZED ALLERGENIC RHIZOPUS ARRHIZUS VAR ARRHIZUS RHIZOPUS BATATAS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0939_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0939 NON-STANDARDIZED ALLERGENIC RHODOTORULA RUBRA RHODOTORULA RUBRA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHODOTORULA RUBRA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0940_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0940 NON-STANDARDIZED ALLERGENIC RHODOTORULA RUBRA RHODOTORULA RUBRA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHODOTORULA RUBRA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0941_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0941 NON-STANDARDIZED ALLERGENIC RHODOTORULA RUBRA RHODOTORULA RUBRA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHODOTORULA RUBRA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0942_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0942 NON-STANDARDIZED ALLERGENIC RHODOTORULA RUBRA RHODOTORULA RUBRA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHODOTORULA RUBRA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0943_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0943 NON-STANDARDIZED ALLERGENIC RHODOTORULA RUBRA RHODOTORULA RUBRA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHODOTORULA RUBRA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0944_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0944 NON-STANDARDIZED ALLERGENIC RHODOTORULA RUBRA RHODOTORULA RUBRA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHODOTORULA RUBRA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0945_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0945 NON-STANDARDIZED ALLERGENIC USTILAGO MAYDIS CORN SMUT INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. USTILAGO MAYDIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0946_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0946 NON-STANDARDIZED ALLERGENIC USTILAGO MAYDIS CORN SMUT INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. USTILAGO MAYDIS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0952_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0952 NON-STANDARDIZED ALLERGENIC USTILAGO TRITICI LOOSE WHEAT SMUT INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. USTILAGO TRITICI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0955_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0955 NON-STANDARDIZED ALLERGENIC STEMPHYLIUM SOLANI STEMPHYLIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. STEMPHYLIUM SOLANI 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0956_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0956 NON-STANDARDIZED ALLERGENIC STEMPHYLIUM SOLANI STEMPHYLIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. STEMPHYLIUM SOLANI 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0957_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0957 NON-STANDARDIZED ALLERGENIC STEMPHYLIUM SOLANI STEMPHYLIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. STEMPHYLIUM SOLANI 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0958_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0958 NON-STANDARDIZED ALLERGENIC STEMPHYLIUM SOLANI STEMPHYLIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. STEMPHYLIUM SOLANI .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0959_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0959 NON-STANDARDIZED ALLERGENIC STEMPHYLIUM SOLANI STEMPHYLIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. STEMPHYLIUM SOLANI 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0961_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0961 NON-STANDARDIZED ALLERGENIC TRICHOPHYTON MENTAGROPHYTES TRICHOPHYTON MENTAGROPHYTES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRICHOPHYTON MENTAGROPHYTES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0962_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0962 NON-STANDARDIZED ALLERGENIC TRICHOPHYTON MENTAGROPHYTES TRICHOPHYTON MENTAGROPHYTES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRICHOPHYTON MENTAGROPHYTES 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0963_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0963 NON-STANDARDIZED ALLERGENIC TRICHOPHYTON MENTAGROPHYTES TRICHOPHYTON MENTAGROPHYTES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRICHOPHYTON MENTAGROPHYTES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0965_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0965 NON-STANDARDIZED ALLERGENIC TRICHOPHYTON MENTAGROPHYTES TRICHOPHYTON MENTAGROPHYTES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRICHOPHYTON MENTAGROPHYTES .005 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0966_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0966 NON-STANDARDIZED ALLERGENIC TRICHOPHYTON MENTAGROPHYTES TRICHOPHYTON MENTAGROPHYTES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRICHOPHYTON MENTAGROPHYTES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0967_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0967 NON-STANDARDIZED ALLERGENIC TRICHOPHYTON MENTAGROPHYTES TRICHOPHYTON MENTAGROPHYTES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRICHOPHYTON MENTAGROPHYTES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-0968_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0968 NON-STANDARDIZED ALLERGENIC SACCHAROMYCES CEREVISIAE SACCHAROMYCES CEREVISIAE INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SACCHAROMYCES CEREVISIAE 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 0268-0969_ae94f270-516d-4200-801f-3afd0d482d7d 0268-0969 NON-STANDARDIZED ALLERGENIC SACCHAROMYCES CEREVISIAE SACCHAROMYCES CEREVISIAE INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SACCHAROMYCES CEREVISIAE 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 0268-1000_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1000 NON-STANDARDIZED ALLERGENIC ACACIA Acacia INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACACIA .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1001_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1001 NON-STANDARDIZED ALLERGENIC ACACIA Acacia INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACACIA .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1004_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1004 NON-STANDARDIZED ALLERGENIC AILANTHUS ALTISSIMA POLLEN Ailanthus Tree of Heaven INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AILANTHUS ALTISSIMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1007_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1007 NON-STANDARDIZED ALLERGENIC ALNUS INCANA SSP RUGOSA POLLEN Alder White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1008_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1008 NON-STANDARDIZED ALLERGENIC ALNUS INCANA SSP RUGOSA POLLEN Alder White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1009_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1009 NON-STANDARDIZED ALLERGENIC ALNUS INCANA SSP RUGOSA POLLEN Alder White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1012_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1012 NON-STANDARDIZED ALLERGENIC MEDICAGO SATIVA POLLEN Alfalfa INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MEDICAGO SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1013_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1013 NON-STANDARDIZED ALLERGENIC MEDICAGO SATIVA POLLEN Alfalfa INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MEDICAGO SATIVA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1016_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1016 NON-STANDARDIZED ALLERGENIC FRAXINUS VELUTINA POLLEN Ash Arizona INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS VELUTINA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1017_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1017 NON-STANDARDIZED ALLERGENIC FRAXINUS VELUTINA POLLEN Ash Arizona INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS VELUTINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1018_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1018 NON-STANDARDIZED ALLERGENIC FRAXINUS VELUTINA POLLEN Ash Arizona INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS VELUTINA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1021_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1021 NON-STANDARDIZED ALLERGENIC FRAXINUS AMERICANA POLLEN Ash White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1022_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1022 NON-STANDARDIZED ALLERGENIC FRAXINUS AMERICANA POLLEN Ash White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1023_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1023 NON-STANDARDIZED ALLERGENIC FRAXINUS AMERICANA POLLEN Ash White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1024_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1024 NON-STANDARDIZED ALLERGENIC FRAXINUS AMERICANA POLLEN Ash White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1025_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1025 NON-STANDARDIZED ALLERGENIC FRAXINUS AMERICANA POLLEN Ash White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1026_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1026 NON-STANDARDIZED ALLERGENIC FRAXINUS AMERICANA POLLEN Ash White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1029_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1029 NON-STANDARDIZED ALLERGENIC POPULUS TREMULOIDES POLLEN Aspen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS TREMULOIDES POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1030_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1030 NON-STANDARDIZED ALLERGENIC POPULUS TREMULOIDES POLLEN Aspen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS TREMULOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1033_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1033 NON-STANDARDIZED ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1034_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1034 NON-STANDARDIZED ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1035_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1035 NON-STANDARDIZED ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1036_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1036 NON-STANDARDIZED ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1037_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1037 NON-STANDARDIZED ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1038_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1038 NON-STANDARDIZED ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1041_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1041 NON-STANDARDIZED ALLERGENIC MORELLA CERIFERA POLLEN Bayberry Wax Myrtle INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORELLA CERIFERA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1042_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1042 NON-STANDARDIZED ALLERGENIC MORELLA CERIFERA POLLEN Bayberry Wax Myrtle INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORELLA CERIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1043_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1043 NON-STANDARDIZED ALLERGENIC MORELLA CERIFERA POLLEN Bayberry Wax Myrtle INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORELLA CERIFERA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1046_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1046 NON-STANDARDIZED ALLERGENIC FAGUS GRANDIFOLIA POLLEN Beech INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FAGUS GRANDIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1047_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1047 NON-STANDARDIZED ALLERGENIC FAGUS GRANDIFOLIA POLLEN Beech INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FAGUS GRANDIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1048_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1048 NON-STANDARDIZED ALLERGENIC FAGUS GRANDIFOLIA POLLEN Beech INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FAGUS GRANDIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1049_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1049 NON-STANDARDIZED ALLERGENIC FAGUS GRANDIFOLIA POLLEN Beech INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FAGUS GRANDIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1056_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1056 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1057_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1057 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1058_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1058 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1059_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1059 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN 50000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1062_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1062 NON-STANDARDIZED ALLERGENIC BETULA NIGRA POLLEN Birch River Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1063_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1063 NON-STANDARDIZED ALLERGENIC BETULA NIGRA POLLEN Birch River Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1064_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1064 NON-STANDARDIZED ALLERGENIC BETULA NIGRA POLLEN Birch River Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1065_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1065 NON-STANDARDIZED ALLERGENIC BETULA NIGRA POLLEN Birch River Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1066_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1066 NON-STANDARDIZED ALLERGENIC BETULA NIGRA POLLEN Birch River Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA NIGRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1069_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1069 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1070_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1070 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1071_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1071 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1072_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1072 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .0005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1073_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1073 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1076_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1076 NON-STANDARDIZED ALLERGENIC POA ANNUA POLLEN Bluegrass Annual INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POA ANNUA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1077_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1077 NON-STANDARDIZED ALLERGENIC POA ANNUA POLLEN Bluegrass Annual INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POA ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1080_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1080 NON-STANDARDIZED ALLERGENIC ACER NEGUNDO POLLEN Box Elder Ash Leaf Maple INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER NEGUNDO POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1081_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1081 NON-STANDARDIZED ALLERGENIC ACER NEGUNDO POLLEN Box Elder Ash Leaf Maple INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER NEGUNDO POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1082_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1082 NON-STANDARDIZED ALLERGENIC ACER NEGUNDO POLLEN Box Elder Ash Leaf Maple INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER NEGUNDO POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1083_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1083 NON-STANDARDIZED ALLERGENIC ACER NEGUNDO POLLEN Box Elder Ash Leaf Maple INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER NEGUNDO POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1086_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1086 NON-STANDARDIZED ALLERGENIC BROMUS INERMIS POLLEN Brome Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BROMUS INERMIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1087_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1087 NON-STANDARDIZED ALLERGENIC BROMUS INERMIS POLLEN Brome Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1088_816293f6-fbb5-4ef6-b37c-6f2eefabdbd9 0268-1088 HUMAN PRESCRIPTION DRUG CENTER-AL - BROMUS INERMIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. BROMUS INERMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1089_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1089 NON-STANDARDIZED ALLERGENIC BROMUS INERMIS POLLEN Brome Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BROMUS INERMIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1092_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1092 NON-STANDARDIZED ALLERGENIC AMARANTHUS PALMERI POLLEN Carelessweed INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1093_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1093 NON-STANDARDIZED ALLERGENIC AMARANTHUS PALMERI POLLEN Carelessweed INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS PALMERI POLLEN .025 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1094_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1094 NON-STANDARDIZED ALLERGENIC AMARANTHUS PALMERI POLLEN Carelessweed INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS PALMERI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1097_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1097 NON-STANDARDIZED ALLERGENIC JUNIPERUS ASHEI POLLEN Cedar Mountain INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS ASHEI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1098_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1098 NON-STANDARDIZED ALLERGENIC JUNIPERUS ASHEI POLLEN Cedar Mountain INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1099_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1099 NON-STANDARDIZED ALLERGENIC JUNIPERUS ASHEI POLLEN Cedar Mountain INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS ASHEI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1102_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1102 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1103_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1103 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1104_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1104 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN .005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1105_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1105 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN .0005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1106_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1106 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1107_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1107 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1110_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1110 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1111_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1111 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1112_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1112 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1113_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1113 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1114_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1114 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 10 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1115_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1115 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 100 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1116_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1116 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1117_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1117 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1120_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1120 NON-STANDARDIZED ALLERGENIC ZEA MAYS POLLEN Corn Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ZEA MAYS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1121_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1121 NON-STANDARDIZED ALLERGENIC ZEA MAYS POLLEN Corn Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ZEA MAYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1122_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1122 NON-STANDARDIZED ALLERGENIC ZEA MAYS POLLEN Corn Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ZEA MAYS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1123_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1123 NON-STANDARDIZED ALLERGENIC ZEA MAYS POLLEN Corn Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ZEA MAYS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1126_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1126 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES POLLEN Cottonwood Eastern Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1127_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1127 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES POLLEN Cottonwood Eastern Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1128_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1128 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES POLLEN Cottonwood Eastern Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1129_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1129 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES POLLEN Cottonwood Eastern Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1130_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1130 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES POLLEN Cottonwood Eastern Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1133_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1133 NON-STANDARDIZED ALLERGENIC POPULUS FREMONTII POLLEN Cottonwood Fremont INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS FREMONTII POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1134_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1134 NON-STANDARDIZED ALLERGENIC POPULUS FREMONTII POLLEN Cottonwood Fremont INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS FREMONTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1135_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1135 NON-STANDARDIZED ALLERGENIC POPULUS FREMONTII POLLEN Cottonwood Fremont INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS FREMONTII POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1138_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1138 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES SSP MONILIFERA POLLEN Cottonwood Western INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1139_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1139 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES SSP MONILIFERA POLLEN Cottonwood Western INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1142_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1142 NON-STANDARDIZED ALLERGENIC CUPRESSUS ARIZONICA POLLEN Cypress Arizona INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CUPRESSUS ARIZONICA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1143_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1143 NON-STANDARDIZED ALLERGENIC CUPRESSUS ARIZONICA POLLEN Cypress Arizona INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CUPRESSUS ARIZONICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1146_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1146 NON-STANDARDIZED ALLERGENIC TAXODIUM DISTICHUM POLLEN Cypress Bald INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TAXODIUM DISTICHUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1147_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1147 NON-STANDARDIZED ALLERGENIC TAXODIUM DISTICHUM POLLEN Cypress Bald INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TAXODIUM DISTICHUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1148_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1148 NON-STANDARDIZED ALLERGENIC TAXODIUM DISTICHUM POLLEN Cypress Bald INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TAXODIUM DISTICHUM POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1151_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1151 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Dock Sour Sheep Sorrel INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 0268-1152_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1152 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Dock Sour Sheep Sorrel INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 0268-1153_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1153 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Dock Sour Sheep Sorrel INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 0268-1154_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1154 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Dock Sour Sheep Sorrel INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 0268-1155_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1155 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Dock Sour Sheep Sorrel INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 0268-1156_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1156 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Dock Sour Sheep Sorrel INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN 60000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 0268-1159_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1159 NON-STANDARDIZED ALLERGENIC RUMEX CRISPUS POLLEN Dock Yellow INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX CRISPUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1160_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1160 NON-STANDARDIZED ALLERGENIC RUMEX CRISPUS POLLEN Dock Yellow INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX CRISPUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1161_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1161 NON-STANDARDIZED ALLERGENIC RUMEX CRISPUS POLLEN Dock Yellow INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX CRISPUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1164_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1164 NON-STANDARDIZED ALLERGENIC EUPATORIUM CAPILLIFOLIUM POLLEN Dog Fennel INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1165_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1165 NON-STANDARDIZED ALLERGENIC EUPATORIUM CAPILLIFOLIUM POLLEN Dog Fennel Non Stock INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1168_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1168 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN Elm American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1169_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1169 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN Elm American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1170_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1170 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN Elm American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1171_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1171 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN Elm American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN .005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1172_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1172 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN Elm American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN .0005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1173_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1173 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN Elm American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1174_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1174 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN Elm American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1177_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1177 NON-STANDARDIZED ALLERGENIC ULMUS CRASSIFOLIA POLLEN Elm Cedar INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS CRASSIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1178_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1178 NON-STANDARDIZED ALLERGENIC ULMUS CRASSIFOLIA POLLEN Elm Cedar INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS CRASSIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1181_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1181 NON-STANDARDIZED ALLERGENIC ULMUS PUMILA POLLEN Elm Chinese INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS PUMILA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1182_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1182 NON-STANDARDIZED ALLERGENIC ULMUS PUMILA POLLEN Elm Chinese INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS PUMILA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1185_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1185 NON-STANDARDIZED ALLERGENIC EUCALYPTUS GLOBULUS POLLEN Eucalyptus INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EUCALYPTUS GLOBULUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1186_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1186 NON-STANDARDIZED ALLERGENIC EUCALYPTUS GLOBULUS POLLEN Eucalyptus INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EUCALYPTUS GLOBULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1187_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1187 NON-STANDARDIZED ALLERGENIC EUCALYPTUS GLOBULUS POLLEN Eucalyptus INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EUCALYPTUS GLOBULUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1188_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1188 NON-STANDARDIZED ALLERGENIC EUCALYPTUS GLOBULUS POLLEN Eucalyptus INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EUCALYPTUS GLOBULUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1191_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1191 NON-STANDARDIZED ALLERGENIC SOLIDAGO CANADENSIS POLLEN Goldenrod INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLIDAGO CANADENSIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1192_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1192 NON-STANDARDIZED ALLERGENIC SOLIDAGO CANADENSIS POLLEN Goldenrod INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLIDAGO CANADENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1193_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1193 NON-STANDARDIZED ALLERGENIC SOLIDAGO CANADENSIS POLLEN Goldenrod INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLIDAGO CANADENSIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1194_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1194 NON-STANDARDIZED ALLERGENIC SOLIDAGO CANADENSIS POLLEN Goldenrod INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLIDAGO CANADENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1195_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1195 NON-STANDARDIZED ALLERGENIC SOLIDAGO CANADENSIS POLLEN Goldenrod INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLIDAGO CANADENSIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1198_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1198 NON-STANDARDIZED ALLERGENIC CELTIS OCCIDENTALIS POLLEN Hackberry INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CELTIS OCCIDENTALIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1199_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1199 NON-STANDARDIZED ALLERGENIC CELTIS OCCIDENTALIS POLLEN Hackberry INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CELTIS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1200_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1200 NON-STANDARDIZED ALLERGENIC CELTIS OCCIDENTALIS POLLEN Hackberry INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CELTIS OCCIDENTALIS POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1203_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1203 NON-STANDARDIZED ALLERGENIC CORYLUS AMERICANA POLLEN Hazelnut Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CORYLUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1204_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1204 NON-STANDARDIZED ALLERGENIC CORYLUS AMERICANA POLLEN Hazelnut Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CORYLUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1205_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1205 NON-STANDARDIZED ALLERGENIC CORYLUS AMERICANA POLLEN Hazelnut Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CORYLUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1206_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1206 NON-STANDARDIZED ALLERGENIC CORYLUS AMERICANA POLLEN Hazelnut Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CORYLUS AMERICANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1214_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1214 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1215_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1215 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1216_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1216 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1217_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1217 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN .005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1218_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1218 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN .0005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1219_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1219 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1220_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1220 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1223_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1223 NON-STANDARDIZED ALLERGENIC JUNIPERUS CALIFORNICA POLLEN Juniper Western INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS CALIFORNICA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1224_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1224 NON-STANDARDIZED ALLERGENIC JUNIPERUS CALIFORNICA POLLEN Juniper Western INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1225_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1225 NON-STANDARDIZED ALLERGENIC JUNIPERUS CALIFORNICA POLLEN Juniper Western INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS CALIFORNICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1232_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1232 NON-STANDARDIZED ALLERGENIC KOCHIA SCOPARIA POLLEN Kochia Firebush INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. KOCHIA SCOPARIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1233_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1233 NON-STANDARDIZED ALLERGENIC KOCHIA SCOPARIA POLLEN Kochia Firebush INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. KOCHIA SCOPARIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1234_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1234 NON-STANDARDIZED ALLERGENIC KOCHIA SCOPARIA POLLEN Kochia Firebush INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. KOCHIA SCOPARIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1235_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1235 NON-STANDARDIZED ALLERGENIC KOCHIA SCOPARIA POLLEN Kochia Firebush INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. KOCHIA SCOPARIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1238_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1238 NON-STANDARDIZED ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1239_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1239 NON-STANDARDIZED ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1240_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1240 NON-STANDARDIZED ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1241_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1241 NON-STANDARDIZED ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1242_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1242 NON-STANDARDIZED ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1245_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1245 NON-STANDARDIZED ALLERGENIC ROBINIA PSEUDOACACIA POLLEN Locust Black Non Stock INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ROBINIA PSEUDOACACIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1248_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1248 NON-STANDARDIZED ALLERGENIC ACER RUBRUM POLLEN Maple Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER RUBRUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1249_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1249 NON-STANDARDIZED ALLERGENIC ACER RUBRUM POLLEN Maple Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER RUBRUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1252_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1252 NON-STANDARDIZED ALLERGENIC ACER SACCHARUM POLLEN Maple Sugar INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER SACCHARUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1253_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1253 NON-STANDARDIZED ALLERGENIC ACER SACCHARUM POLLEN Maple Sugar INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER SACCHARUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1254_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1254 NON-STANDARDIZED ALLERGENIC ACER SACCHARUM POLLEN Maple Sugar INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER SACCHARUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1255_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1255 NON-STANDARDIZED ALLERGENIC ACER SACCHARUM POLLEN Maple Sugar INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER SACCHARUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1258_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1258 NON-STANDARDIZED ALLERGENIC IVA XANTHIFOLIA POLLEN Marshelder Burweed INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. IVA XANTHIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1259_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1259 NON-STANDARDIZED ALLERGENIC IVA XANTHIFOLIA POLLEN Marshelder Burweed INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. IVA XANTHIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1260_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1260 NON-STANDARDIZED ALLERGENIC IVA XANTHIFOLIA POLLEN Marshelder Burweed INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. IVA XANTHIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1263_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1263 NON-STANDARDIZED ALLERGENIC IVA ANNUA VAR ANNUA POLLEN Marshelder Rough INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. IVA ANNUA VAR. ANNUA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1264_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1264 NON-STANDARDIZED ALLERGENIC IVA ANNUA VAR ANNUA POLLEN Marshelder Rough INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. IVA ANNUA VAR. ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1265_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1265 NON-STANDARDIZED ALLERGENIC IVA ANNUA VAR ANNUA POLLEN Marshelder Rough INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. IVA ANNUA VAR. ANNUA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1266_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1266 NON-STANDARDIZED ALLERGENIC IVA ANNUA VAR ANNUA POLLEN Marshelder Rough INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. IVA ANNUA VAR. ANNUA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1273_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1273 NON-STANDARDIZED ALLERGENIC MELALEUCA QUINQUENERVIA POLLEN Melaleuca Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MELALEUCA QUINQUENERVIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1274_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1274 NON-STANDARDIZED ALLERGENIC MELALEUCA QUINQUENERVIA POLLEN Melaleuca Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MELALEUCA QUINQUENERVIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1275_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1275 NON-STANDARDIZED ALLERGENIC MELALEUCA QUINQUENERVIA POLLEN Melaleuca Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MELALEUCA QUINQUENERVIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1276_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1276 NON-STANDARDIZED ALLERGENIC MELALEUCA QUINQUENERVIA POLLEN Melaleuca Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MELALEUCA QUINQUENERVIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1279_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1279 NON-STANDARDIZED ALLERGENIC PROSOPIS JULIFLORA POLLEN Mesquite INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PROSOPIS JULIFLORA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1280_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1280 NON-STANDARDIZED ALLERGENIC PROSOPIS JULIFLORA POLLEN Mesquite INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PROSOPIS JULIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1281_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1281 NON-STANDARDIZED ALLERGENIC PROSOPIS JULIFLORA POLLEN Mesquite INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PROSOPIS JULIFLORA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1284_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1284 NON-STANDARDIZED ALLERGENIC CHENOPODIUM AMBROSIOIDES POLLEN Mexican Tea INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM AMBROSIOIDES POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1285_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1285 NON-STANDARDIZED ALLERGENIC CHENOPODIUM AMBROSIOIDES POLLEN Mexican Tea INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM AMBROSIOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1286_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1286 NON-STANDARDIZED ALLERGENIC CHENOPODIUM AMBROSIOIDES POLLEN Mexican Tea INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM AMBROSIOIDES POLLEN .025 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1297_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1297 NON-STANDARDIZED ALLERGENIC ARTEMISIA VULGARIS POLLEN Mugwort Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA VULGARIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1298_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1298 NON-STANDARDIZED ALLERGENIC ARTEMISIA VULGARIS POLLEN Mugwort Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1299_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1299 NON-STANDARDIZED ALLERGENIC ARTEMISIA VULGARIS POLLEN Mugwort Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA VULGARIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1300_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1300 NON-STANDARDIZED ALLERGENIC ARTEMISIA VULGARIS POLLEN Mugwort Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA VULGARIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1301_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1301 NON-STANDARDIZED ALLERGENIC ARTEMISIA VULGARIS POLLEN Mugwort Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA VULGARIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1304_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1304 NON-STANDARDIZED ALLERGENIC MORUS RUBRA POLLEN Mulberry Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS RUBRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1305_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1305 NON-STANDARDIZED ALLERGENIC MORUS RUBRA POLLEN Mulberry Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1306_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1306 NON-STANDARDIZED ALLERGENIC MORUS RUBRA POLLEN Mulberry Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS RUBRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1307_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1307 NON-STANDARDIZED ALLERGENIC MORUS RUBRA POLLEN Mulberry Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS RUBRA POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1310_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1310 NON-STANDARDIZED ALLERGENIC MORUS ALBA POLLEN Mulberry White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1311_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1311 NON-STANDARDIZED ALLERGENIC MORUS ALBA POLLEN Mulberry White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1314_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1314 NON-STANDARDIZED ALLERGENIC QUERCUS AGRIFOLIA POLLEN Oak California Live Coast INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS AGRIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1315_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1315 NON-STANDARDIZED ALLERGENIC QUERCUS AGRIFOLIA POLLEN Oak California Live Coast INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS AGRIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1318_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1318 NON-STANDARDIZED ALLERGENIC QUERCUS RUBRA POLLEN Oak Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS RUBRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1319_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1319 NON-STANDARDIZED ALLERGENIC QUERCUS RUBRA POLLEN Oak Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1322_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1322 NON-STANDARDIZED ALLERGENIC QUERCUS VIRGINIANA POLLEN Oak Virginia Live INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS VIRGINIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1323_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1323 NON-STANDARDIZED ALLERGENIC QUERCUS VIRGINIANA POLLEN Oak Virginia Live INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1324_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1324 NON-STANDARDIZED ALLERGENIC QUERCUS VIRGINIANA POLLEN Oak Virginia Live INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS VIRGINIANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1327_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1327 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oak White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1328_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1328 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oak White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1329_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1329 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oak White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1330_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1330 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oak White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1331_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1331 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oak White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1332_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1332 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oak White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN 50000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1333_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1333 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oak White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1336_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1336 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oat Wild Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1339_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1339 NON-STANDARDIZED ALLERGENIC OLEA EUROPAEA POLLEN Olive Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. OLEA EUROPAEA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1340_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1340 NON-STANDARDIZED ALLERGENIC OLEA EUROPAEA POLLEN Olive Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. OLEA EUROPAEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1347_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1347 NON-STANDARDIZED ALLERGENIC SYAGRUS ROMANZOFFIANA POLLEN Palm Queen Coco Palm INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SYAGRUS ROMANZOFFIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1348_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1348 NON-STANDARDIZED ALLERGENIC SYAGRUS ROMANZOFFIANA POLLEN Palm Queen Coco Palm INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SYAGRUS ROMANZOFFIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1354_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1354 NON-STANDARDIZED ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1355_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1355 NON-STANDARDIZED ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1356_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1356 NON-STANDARDIZED ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1357_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1357 NON-STANDARDIZED ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1358_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1358 NON-STANDARDIZED ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1361_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1361 NON-STANDARDIZED ALLERGENIC SCHINUS MOLLE POLLEN Pepper Tree California INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SCHINUS MOLLE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1364_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1364 NON-STANDARDIZED ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Pigweed Rough Redroot INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1365_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1365 NON-STANDARDIZED ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Pigweed Rough Redroot INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1366_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1366 NON-STANDARDIZED ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Pigweed Rough Redroot INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1367_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1367 NON-STANDARDIZED ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Pigweed Rough Redroot INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1368_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1368 NON-STANDARDIZED ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Pigweed Rough Redroot INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1371_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1371 NON-STANDARDIZED ALLERGENIC AMARANTHUS SPINOSUS POLLEN Pigweed Spiny INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS SPINOSUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1372_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1372 NON-STANDARDIZED ALLERGENIC AMARANTHUS SPINOSUS POLLEN Pigweed Spiny INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS SPINOSUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1373_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1373 NON-STANDARDIZED ALLERGENIC AMARANTHUS SPINOSUS POLLEN Pigweed Spiny INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS SPINOSUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1376_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1376 NON-STANDARDIZED ALLERGENIC CASUARINA EQUISETIFOLIA POLLEN Pine Australian Beefwood INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CASUARINA EQUISETIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1377_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1377 NON-STANDARDIZED ALLERGENIC CASUARINA EQUISETIFOLIA POLLEN Pine Australian Beefwood INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CASUARINA EQUISETIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1378_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1378 NON-STANDARDIZED ALLERGENIC CASUARINA EQUISETIFOLIA POLLEN Pine Australian Beefwood INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CASUARINA EQUISETIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1379_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1379 NON-STANDARDIZED ALLERGENIC CASUARINA EQUISETIFOLIA POLLEN Pine Australian Beefwood INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CASUARINA EQUISETIFOLIA POLLEN 50000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1382_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1382 NON-STANDARDIZED ALLERGENIC PINUS STROBUS POLLEN Pine White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS STROBUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1383_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1383 NON-STANDARDIZED ALLERGENIC PINUS STROBUS POLLEN Pine White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS STROBUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1384_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1384 NON-STANDARDIZED ALLERGENIC PINUS STROBUS POLLEN Pine White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS STROBUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1385_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1385 NON-STANDARDIZED ALLERGENIC PINUS STROBUS POLLEN Pine White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS STROBUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1386_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1386 NON-STANDARDIZED ALLERGENIC PINUS STROBUS POLLEN Pine White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS STROBUS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1389_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1389 NON-STANDARDIZED ALLERGENIC PINUS ECHINATA POLLEN Pine Yellow INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS ECHINATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1390_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1390 NON-STANDARDIZED ALLERGENIC PINUS ECHINATA POLLEN Pine Yellow INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS ECHINATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1394_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1394 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1395_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1395 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1396_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1396 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1397_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1397 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 100 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1398_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1398 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1399_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1399 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1400_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1400 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1401_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1401 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 10 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1402_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1402 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1405_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1405 NON-STANDARDIZED ALLERGENIC POPULUS ALBA POLLEN Poplar White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1406_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1406 NON-STANDARDIZED ALLERGENIC POPULUS ALBA POLLEN Poplar White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1407_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1407 NON-STANDARDIZED ALLERGENIC POPULUS ALBA POLLEN Poplar White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS ALBA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1408_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1408 NON-STANDARDIZED ALLERGENIC POPULUS ALBA POLLEN Poplar White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS ALBA POLLEN .005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1409_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1409 NON-STANDARDIZED ALLERGENIC POPULUS ALBA POLLEN Poplar White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS ALBA POLLEN .0005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1412_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1412 NON-STANDARDIZED ALLERGENIC LIGUSTRUM VULGARE POLLEN Privet INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIGUSTRUM VULGARE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1413_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1413 NON-STANDARDIZED ALLERGENIC LIGUSTRUM VULGARE POLLEN Privet INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIGUSTRUM VULGARE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1414_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1414 NON-STANDARDIZED ALLERGENIC LIGUSTRUM VULGARE POLLEN Privet INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIGUSTRUM VULGARE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1415_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1415 NON-STANDARDIZED ALLERGENIC LIGUSTRUM VULGARE POLLEN Privet INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIGUSTRUM VULGARE POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1418_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1418 NON-STANDARDIZED ALLERGENIC ELYMUS REPENS POLLEN Quack Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ELYMUS REPENS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1419_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1419 NON-STANDARDIZED ALLERGENIC ELYMUS REPENS POLLEN Quack Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ELYMUS REPENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1420_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1420 NON-STANDARDIZED ALLERGENIC ELYMUS REPENS POLLEN Quack Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ELYMUS REPENS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1423_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1423 NON-STANDARDIZED ALLERGENIC AMBROSIA ACANTHICARPA POLLEN Ragweed False Bur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ACANTHICARPA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1424_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1424 NON-STANDARDIZED ALLERGENIC AMBROSIA ACANTHICARPA POLLEN Ragweed False Bur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ACANTHICARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1431_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1431 NON-STANDARDIZED ALLERGENIC AMBROSIA TENUIFOLIA POLLEN Ragweed Slender INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TENUIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1432_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1432 NON-STANDARDIZED ALLERGENIC AMBROSIA TENUIFOLIA POLLEN Ragweed Slender INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TENUIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1435_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1435 NON-STANDARDIZED ALLERGENIC AMBROSIA BIDENTATA POLLEN Ragweed Southern INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA BIDENTATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1436_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1436 NON-STANDARDIZED ALLERGENIC AMBROSIA BIDENTATA POLLEN Ragweed Southern INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA BIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1439_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1439 NON-STANDARDIZED ALLERGENIC AMBROSIA TRIFIDA POLLEN Ragweed Tall Giant INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TRIFIDA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1440_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1440 NON-STANDARDIZED ALLERGENIC AMBROSIA TRIFIDA POLLEN Ragweed Tall Giant INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TRIFIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1441_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1441 NON-STANDARDIZED ALLERGENIC AMBROSIA TRIFIDA POLLEN Ragweed Tall Giant INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TRIFIDA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1442_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1442 NON-STANDARDIZED ALLERGENIC AMBROSIA TRIFIDA POLLEN Ragweed Tall Giant INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TRIFIDA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1445_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1445 NON-STANDARDIZED ALLERGENIC AMBROSIA PSILOSTACHYA POLLEN Ragweed Western INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA PSILOSTACHYA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1446_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1446 NON-STANDARDIZED ALLERGENIC AMBROSIA PSILOSTACHYA POLLEN Ragweed Western INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA PSILOSTACHYA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1453_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1453 NON-STANDARDIZED ALLERGENIC SALSOLA KALI POLLEN Russian Thistle INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALSOLA KALI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1454_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1454 NON-STANDARDIZED ALLERGENIC SALSOLA KALI POLLEN Russian Thistle INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALSOLA KALI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1455_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1455 NON-STANDARDIZED ALLERGENIC SALSOLA KALI POLLEN Russian Thistle INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALSOLA KALI POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1456_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1456 NON-STANDARDIZED ALLERGENIC SALSOLA KALI POLLEN Russian Thistle INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALSOLA KALI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1457_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1457 NON-STANDARDIZED ALLERGENIC SALSOLA KALI POLLEN Russian Thistle INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALSOLA KALI POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1460_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1460 NON-STANDARDIZED ALLERGENIC LOLIUM PERENNE SSP MULTIFLORUM POLLEN Rye Grass Italian INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1467_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1467 NON-STANDARDIZED ALLERGENIC ARTEMISIA FRIGIDA POLLEN Sage Prairie INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA FRIGIDA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1468_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1468 NON-STANDARDIZED ALLERGENIC ARTEMISIA FRIGIDA POLLEN Sage Prairie INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA FRIGIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1471_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1471 NON-STANDARDIZED ALLERGENIC ARTEMISIA TRIDENTATA POLLEN Sagebrush Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA TRIDENTATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1472_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1472 NON-STANDARDIZED ALLERGENIC ARTEMISIA TRIDENTATA POLLEN Sagebrush Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA TRIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1473_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1473 NON-STANDARDIZED ALLERGENIC ARTEMISIA TRIDENTATA POLLEN Sagebrush Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA TRIDENTATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1476_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1476 NON-STANDARDIZED ALLERGENIC DISTICHLIS SPICATA POLLEN Salt Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. DISTICHLIS SPICATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1477_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1477 NON-STANDARDIZED ALLERGENIC DISTICHLIS SPICATA POLLEN Salt Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. DISTICHLIS SPICATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1480_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1480 NON-STANDARDIZED ALLERGENIC ATRIPLEX WRIGHTII POLLEN Saltbush Annual Atriplex INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ATRIPLEX WRIGHTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1481_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1481 NON-STANDARDIZED ALLERGENIC ATRIPLEX WRIGHTII POLLEN Saltbush Annual Atriplex INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ATRIPLEX WRIGHTII POLLEN .025 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1493_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1493 NON-STANDARDIZED ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1494_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1494 NON-STANDARDIZED ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1495_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1495 NON-STANDARDIZED ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1496_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1496 NON-STANDARDIZED ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .0005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1497_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1497 NON-STANDARDIZED ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1498_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1498 NON-STANDARDIZED ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1501_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1501 NON-STANDARDIZED ALLERGENIC PLATANUS OCCIDENTALIS POLLEN Sycamore American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLATANUS OCCIDENTALIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1502_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1502 NON-STANDARDIZED ALLERGENIC PLATANUS OCCIDENTALIS POLLEN Sycamore American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLATANUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1503_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1503 NON-STANDARDIZED ALLERGENIC PLATANUS OCCIDENTALIS POLLEN Sycamore American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLATANUS OCCIDENTALIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1504_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1504 NON-STANDARDIZED ALLERGENIC PLATANUS OCCIDENTALIS POLLEN Sycamore American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLATANUS OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1505_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1505 NON-STANDARDIZED ALLERGENIC PLATANUS OCCIDENTALIS POLLEN Sycamore American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLATANUS OCCIDENTALIS POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1510_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1510 NON-STANDARDIZED ALLERGENIC HOLCUS LANATUS POLLEN Velvet Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOLCUS LANATUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1511_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1511 NON-STANDARDIZED ALLERGENIC HOLCUS LANATUS POLLEN Velvet Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOLCUS LANATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1512_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1512 NON-STANDARDIZED ALLERGENIC JUGLANS NIGRA POLLEN Walnut Black Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1513_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1513 NON-STANDARDIZED ALLERGENIC JUGLANS NIGRA POLLEN Walnut Black Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1514_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1514 NON-STANDARDIZED ALLERGENIC JUGLANS NIGRA POLLEN Walnut Black Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1515_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1515 NON-STANDARDIZED ALLERGENIC JUGLANS NIGRA POLLEN Walnut California Black Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1516_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1516 NON-STANDARDIZED ALLERGENIC JUGLANS REGIA POLLEN Walnut English Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS REGIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1517_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1517 NON-STANDARDIZED ALLERGENIC JUGLANS REGIA POLLEN Walnut English Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS REGIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1518_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1518 NON-STANDARDIZED ALLERGENIC AMARANTHUS TUBERCULATUS POLLEN Water Hemp INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS TUBERCULATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1519_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1519 NON-STANDARDIZED ALLERGENIC AMARANTHUS TUBERCULATUS POLLEN Water Hemp INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS TUBERCULATUS POLLEN .025 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1520_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1520 NON-STANDARDIZED ALLERGENIC AMARANTHUS TUBERCULATUS POLLEN Water Hemp INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS TUBERCULATUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1521_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1521 NON-STANDARDIZED ALLERGENIC AMARANTHUS TUBERCULATUS POLLEN Water Hemp INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS TUBERCULATUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1522_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1522 NON-STANDARDIZED ALLERGENIC TRITICUM AESTIVUM POLLEN Wheat Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRITICUM AESTIVUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1523_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1523 NON-STANDARDIZED ALLERGENIC TRITICUM AESTIVUM POLLEN Wheat Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRITICUM AESTIVUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1524_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1524 NON-STANDARDIZED ALLERGENIC SALIX NIGRA POLLEN Willow Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1525_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1525 NON-STANDARDIZED ALLERGENIC SALIX NIGRA POLLEN Willow Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1526_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1526 NON-STANDARDIZED ALLERGENIC SALIX NIGRA POLLEN Willow Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1527_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1527 NON-STANDARDIZED ALLERGENIC SALIX NIGRA POLLEN Willow Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1528_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1528 NON-STANDARDIZED ALLERGENIC SALIX NIGRA POLLEN Willow Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1529_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1529 NON-STANDARDIZED ALLERGENIC SALIX NIGRA POLLEN Willow Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1530_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1530 NON-STANDARDIZED ALLERGENIC ARTEMISIA ANNUA POLLEN Wormwood Common Annual INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1531_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1531 NON-STANDARDIZED ALLERGENIC AMBROSIA ARTEMISIIFOLIA POLLEN Ragweed Short INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN .1 g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1532_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1532 NON-STANDARDIZED ALLERGENIC AMBROSIA ARTEMISIIFOLIA POLLEN Ragweed Short INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN .05 g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1533_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1533 NON-STANDARDIZED ALLERGENIC AMBROSIA ARTEMISIIFOLIA POLLEN Ragweed Short INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1534_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1534 NON-STANDARDIZED ALLERGENIC AMBROSIA ARTEMISIIFOLIA POLLEN Ragweed Short INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 40000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1600_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1600 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1601_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1601 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN HORSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1602_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1602 NON-STANDARDIZED ALLERGENIC JUNIPERUS ASHEI POLLEN Cedar Mountain INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1603_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1603 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1604_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1604 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1605_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1605 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES POLLEN Cottonwood Eastern Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1606_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1606 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Dock Sour Sheep Sorrel INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 0268-1607_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1607 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN Elm American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1608_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1608 NON-STANDARDIZED ALLERGENIC SOLIDAGO CANADENSIS POLLEN Goldenrod INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLIDAGO CANADENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1609_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1609 NON-STANDARDIZED ALLERGENIC JUNIPERUS CALIFORNICA POLLEN Juniper Western INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1610_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1610 NON-STANDARDIZED ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1611_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1611 NON-STANDARDIZED ALLERGENIC CHENOPODIUM AMBROSIOIDES POLLEN Mexican Tea INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM AMBROSIOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1612_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1612 NON-STANDARDIZED ALLERGENIC QUERCUS AGRIFOLIA POLLEN Oak California Live Coast INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS AGRIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1613_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1613 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oak White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1614_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1614 NON-STANDARDIZED ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1615_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1615 NON-STANDARDIZED ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Pigweed Rough Redroot INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-1616_ae94f270-516d-4200-801f-3afd0d482d7d 0268-1616 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-2000_6199232a-c457-4b50-9112-794d25418367 0268-2000 HUMAN PRESCRIPTION DRUG Cat Hair, Standardized Cat Hair, Standardized INJECTION, SOLUTION SUBCUTANEOUS 20031128 BLA BLA103810 ALK-Abello, Inc. FELIS CATUS HAIR 10000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] 0268-2001_6199232a-c457-4b50-9112-794d25418367 0268-2001 HUMAN PRESCRIPTION DRUG Cat Hair, Standardized Cat Hair, Standardized SOLUTION PERCUTANEOUS 20031128 BLA BLA103810 ALK-Abello, Inc. FELIS CATUS HAIR 10000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] 0268-2002_55746080-edfc-4d38-9d49-85a4329bbd2c 0268-2002 HUMAN PRESCRIPTION DRUG Cat Pelt, Standardized Cat Pelt, Standardized SOLUTION PERCUTANEOUS 19920924 BLA BLA103061 ALK-Abello, Inc. FELIS CATUS SKIN 10000 [BAU]/mL Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-3050_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3050 HUMAN PRESCRIPTION DRUG Bermuda Grass, Standardized Bermuda Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103051 ALK-Abello, Inc. CYNODON DACTYLON POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-3051_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3051 HUMAN PRESCRIPTION DRUG Kentucky Bluegrass (June), Standardized Kentucky Bluegrass (June), Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103052 ALK-Abello, Inc. POA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-3052_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3052 HUMAN PRESCRIPTION DRUG Kentucky Bluegrass (June), Standardized Kentucky Bluegrass (June), Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103052 ALK-Abello, Inc. POA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-3053_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3053 HUMAN PRESCRIPTION DRUG Meadow Fescue Grass, Standardized Meadow Fescue Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103053 ALK-Abello, Inc. FESTUCA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-3054_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3054 HUMAN PRESCRIPTION DRUG Meadow Fescue Grass, Standardized Meadow Fescue Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103053 ALK-Abello, Inc. FESTUCA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-3055_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3055 HUMAN PRESCRIPTION DRUG Orchard Grass, Standardized Orchard Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103054 ALK-Abello, Inc. ALLERGENIC EXTRACT- ORCHARD GRASS DACTYLIS GLOMERATA 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-3056_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3056 HUMAN PRESCRIPTION DRUG Orchard Grass, Standardized Orchard Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103054 ALK-Abello, Inc. ALLERGENIC EXTRACT- ORCHARD GRASS DACTYLIS GLOMERATA 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-3057_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3057 HUMAN PRESCRIPTION DRUG Redtop Grass, Standardized Redtop Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103055 ALK-Abello, Inc. AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-3058_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3058 HUMAN PRESCRIPTION DRUG Redtop Grass, Standardized Redtop Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103055 ALK-Abello, Inc. AGROSTIS GIGANTEA POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-3059_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3059 HUMAN PRESCRIPTION DRUG Rye Grass, Perennial Standardized Rye Grass, Perennial Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103056 ALK-Abello, Inc. ALLERGENIC EXTRACT- RYEGRASS, PERENNIAL LOLIUM PERENNE 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-3060_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3060 HUMAN PRESCRIPTION DRUG Rye Grass, Perennial Standardized Rye Grass, Perennial Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103056 ALK-Abello, Inc. ALLERGENIC EXTRACT- RYEGRASS, PERENNIAL LOLIUM PERENNE 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-3061_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3061 HUMAN PRESCRIPTION DRUG Sweet Vernal Grass, Standardized Sweet Vernal Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103057 ALK-Abello, Inc. ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-3062_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3062 HUMAN PRESCRIPTION DRUG Sweet Vernal Grass, Standardized Sweet Vernal Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103057 ALK-Abello, Inc. ANTHOXANTHUM ODORATUM POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-3063_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3063 HUMAN PRESCRIPTION DRUG Timothy, Standardized Timothy, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103058 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-3064_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3064 HUMAN PRESCRIPTION DRUG Timothy, Standardized Timothy, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103058 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6000_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6000 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 10000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-6001_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6001 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 1000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 0268-6100_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6100 NON-STANDARDIZED ALLERGENIC ALMOND Almond Food INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALMOND .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 0268-6101_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6101 NON-STANDARDIZED ALLERGENIC APPLE Apple Food INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. APPLE .1 g/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] 0268-6102_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6102 NON-STANDARDIZED ALLERGENIC APRICOT Apricot INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. APRICOT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6103_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6103 NON-STANDARDIZED ALLERGENIC ASPARAGUS Asparagus INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPARAGUS .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6104_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6104 NON-STANDARDIZED ALLERGENIC AVOCADO Avocado INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AVOCADO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6105_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6105 NON-STANDARDIZED ALLERGENIC BANANA Banana INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BANANA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6106_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6106 NON-STANDARDIZED ALLERGENIC BARLEY Barley Food INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BARLEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 0268-6107_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6107 NON-STANDARDIZED ALLERGENIC BEAN Pinto Bean Kidney Bean INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6108_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6108 NON-STANDARDIZED ALLERGENIC STRING BEAN String Bean Green Bean INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. STRING BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 0268-6109_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6109 NON-STANDARDIZED ALLERGENIC BEEF Beef INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BEEF .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 0268-6110_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6110 NON-STANDARDIZED ALLERGENIC BRAZIL NUT Brazil Nut INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BRAZIL NUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 0268-6112_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6112 NON-STANDARDIZED ALLERGENIC BROCCOLI Broccoli INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BROCCOLI .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6113_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6113 NON-STANDARDIZED ALLERGENIC BUCKWHEAT Buckwheat INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BUCKWHEAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 0268-6114_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6114 NON-STANDARDIZED ALLERGENIC CABBAGE Cabbage INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CABBAGE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6115_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6115 NON-STANDARDIZED ALLERGENIC CANTALOUPE Cantaloupe INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANTALOUPE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6116_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6116 NON-STANDARDIZED ALLERGENIC CARROT Carrot INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARROT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6118_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6118 NON-STANDARDIZED ALLERGENIC CASEIN Casein INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CASEIN .01 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Caseins [Chemical/Ingredient] 0268-6120_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6120 NON-STANDARDIZED ALLERGENIC CELERY Celery INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CELERY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6121_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6121 NON-STANDARDIZED ALLERGENIC CHERRY Cherry INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHERRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6122_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6122 NON-STANDARDIZED ALLERGENIC CHICKEN Chicken Meat INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHICKEN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 0268-6123_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6123 NON-STANDARDIZED ALLERGENIC CINNAMON Cinnamon INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CINNAMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6124_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6124 NON-STANDARDIZED ALLERGENIC CLAM Clam INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLAM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 0268-6125_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6125 NON-STANDARDIZED ALLERGENIC COCOA BEAN Cocoa Bean Whole Bean Chocolate INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCOA BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 0268-6127_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6127 NON-STANDARDIZED ALLERGENIC COCONUT Coconut INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCONUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6128_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6128 NON-STANDARDIZED ALLERGENIC CODFISH Codfish INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CODFISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 0268-6129_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6129 NON-STANDARDIZED ALLERGENIC COFFEE BEAN Coffee INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COFFEE BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 0268-6130_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6130 NON-STANDARDIZED ALLERGENIC CRAB Crab INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CRAB .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 0268-6132_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6132 NON-STANDARDIZED ALLERGENIC CUCUMBER Cucumber INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CUCUMBER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6133_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6133 NON-STANDARDIZED ALLERGENIC EGG WHITE Egg White INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EGG WHITE .01 g/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 0268-6135_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6135 NON-STANDARDIZED ALLERGENIC EGG Whole Egg INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EGG .01 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] 0268-6136_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6136 NON-STANDARDIZED ALLERGENIC EGG YOLK Egg Yolk INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EGG YOLK .01 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] 0268-6137_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6137 NON-STANDARDIZED ALLERGENIC FLOUNDER Flounder INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FLOUNDER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 0268-6138_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6138 NON-STANDARDIZED ALLERGENIC GARLIC Garlic INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. GARLIC .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 0268-6139_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6139 NON-STANDARDIZED ALLERGENIC GRAPE White Seedless Grape INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. GRAPE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6141_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6141 NON-STANDARDIZED ALLERGENIC GRAPEFRUIT Grapefruit INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. GRAPEFRUIT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6143_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6143 NON-STANDARDIZED ALLERGENIC KARAYA GUM Karaya Gum Bassora INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. KARAYA GUM .005 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6146_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6146 NON-STANDARDIZED ALLERGENIC HONEYDEW MELON Honeydew INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HONEYDEW MELON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6149_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6149 NON-STANDARDIZED ALLERGENIC LAMB Lamb INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LAMB .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 0268-6170_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6170 NON-STANDARDIZED ALLERGENIC LEMON Lemon INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LEMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6171_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6171 NON-STANDARDIZED ALLERGENIC LETTUCE Lettuce INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LETTUCE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6173_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6173 NON-STANDARDIZED ALLERGENIC LIMA BEAN Lima Bean INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIMA BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 0268-6174_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6174 NON-STANDARDIZED ALLERGENIC LOBSTER Lobster INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LOBSTER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 0268-6177_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6177 NON-STANDARDIZED ALLERGENIC GOAT MILK Goat Milk INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. GOAT MILK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] 0268-6178_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6178 NON-STANDARDIZED ALLERGENIC COW MILK Milk Whole Cows INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COW MILK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] 0268-6180_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6180 NON-STANDARDIZED ALLERGENIC MUSHROOM Mushroom Agaricus spp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CULTIVATED MUSHROOM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 0268-6181_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6181 NON-STANDARDIZED ALLERGENIC MUSTARD SEED Mustard Seed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUSTARD SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 0268-6183_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6183 NON-STANDARDIZED ALLERGENIC OAT Oat Grain INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. OAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 0268-6185_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6185 NON-STANDARDIZED ALLERGENIC BLACK OLIVE Olive INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLACK OLIVE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6186_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6186 NON-STANDARDIZED ALLERGENIC ONION Onion INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ONION .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6187_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6187 NON-STANDARDIZED ALLERGENIC ORANGE Orange INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ORANGE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6189_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6189 NON-STANDARDIZED ALLERGENIC OYSTER Oyster INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. OYSTER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 0268-6191_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6191 NON-STANDARDIZED ALLERGENIC PEA Green Pea English INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PEA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6192_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6192 NON-STANDARDIZED ALLERGENIC PEACH Peach INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PEACH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6193_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6193 NON-STANDARDIZED ALLERGENIC PEANUT Peanut INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PEANUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 0268-6195_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6195 NON-STANDARDIZED ALLERGENIC PEAR Pear INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PEAR .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6196_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6196 NON-STANDARDIZED ALLERGENIC PECAN Pecan INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PECAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 0268-6197_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6197 NON-STANDARDIZED ALLERGENIC GREEN BELL PEPPER Bell INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. GREEN BELL PEPPER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6198_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6198 NON-STANDARDIZED ALLERGENIC BLACK PEPPER Black Pepper INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLACK PEPPER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6200_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6200 NON-STANDARDIZED ALLERGENIC PINEAPPLE Pineapple INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINEAPPLE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6202_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6202 NON-STANDARDIZED ALLERGENIC PISTACHIO Pistachio Nut INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PISTACHIO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 0268-6203_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6203 NON-STANDARDIZED ALLERGENIC PLUM Plum INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLUM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6204_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6204 NON-STANDARDIZED ALLERGENIC PORK Pork INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PORK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 0268-6205_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6205 NON-STANDARDIZED ALLERGENIC POTATO Sweet Potato INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POTATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6206_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6206 NON-STANDARDIZED ALLERGENIC POTATO White Potato INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POTATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6208_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6208 NON-STANDARDIZED ALLERGENIC RICE Rice INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RICE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 0268-6210_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6210 NON-STANDARDIZED ALLERGENIC RYE Rye INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RYE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 0268-6212_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6212 NON-STANDARDIZED ALLERGENIC SALMON Salmon INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 0268-6213_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6213 NON-STANDARDIZED ALLERGENIC SESAME SEED Sesame Seed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SESAME SEED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 0268-6214_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6214 NON-STANDARDIZED ALLERGENIC SHRIMP Shrimp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SHRIMP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 0268-6216_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6216 NON-STANDARDIZED ALLERGENIC SOYBEAN Soybean INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOYBEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6218_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6218 NON-STANDARDIZED ALLERGENIC SPINACH Spinach INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SPINACH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6219_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6219 NON-STANDARDIZED ALLERGENIC SQUASH Squash INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SQUASH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6220_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6220 NON-STANDARDIZED ALLERGENIC STRAWBERRY Strawberry INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. STRAWBERRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6221_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6221 NON-STANDARDIZED ALLERGENIC CORN Sweet Corn INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CORN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 0268-6224_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6224 NON-STANDARDIZED ALLERGENIC TOMATO Tomato INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TOMATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 0268-6226_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6226 NON-STANDARDIZED ALLERGENIC TUNA Tuna INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TUNA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 0268-6229_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6229 NON-STANDARDIZED ALLERGENIC TURKEY Turkey Meat INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TURKEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 0268-6230_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6230 NON-STANDARDIZED ALLERGENIC VANILLA Vanilla INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. VANILLA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6231_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6231 NON-STANDARDIZED ALLERGENIC ENGLISH WALNUT English Walnut INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ENGLISH WALNUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 0268-6233_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6233 NON-STANDARDIZED ALLERGENIC WATERMELON Watermelon INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. WATERMELON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 0268-6234_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6234 NON-STANDARDIZED ALLERGENIC WHEAT Whole Wheat Wheat Grain INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. WHEAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 0268-6300_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6300 NON-STANDARDIZED ALLERGENIC BOS TAURUS SKIN Cattle Epithelium INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOS TAURUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6301_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6301 NON-STANDARDIZED ALLERGENIC BOS TAURUS SKIN Cattle Epithelium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. BOS TAURUS SKIN 1000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6302_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6302 NON-STANDARDIZED ALLERGENIC COTTON FIBER Cattle Epithelium INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COTTON FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6303_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6303 NON-STANDARDIZED ALLERGENIC COTTON FIBER Cotton Linters INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. COTTON FIBER .001 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6304_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6304 NON-STANDARDIZED ALLERGENIC COTTON SEED Cottonseed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COTTON SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 0268-6305_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6305 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN Dog Epithelium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN 1000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6306_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6306 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN Dog Epithelium INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6308_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6308 NON-STANDARDIZED ALLERGENIC CAVIA PORCELLUS SKIN Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CAVIA PORCELLUS SKIN 1000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6309_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6309 NON-STANDARDIZED ALLERGENIC CAVIA PORCELLUS SKIN Guinea Pig Epithelium INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CAVIA PORCELLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6310_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6310 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN Horse Epithelium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN 1000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6311_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6311 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN Horse Epithelium INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6312_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6312 NON-STANDARDIZED ALLERGENIC CEIBA PENTANDRA FIBER Kapok INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CEIBA PENTANDRA FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6314_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6314 NON-STANDARDIZED ALLERGENIC MUS MUSCULUS SKIN Mouse Epithelium INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUS MUSCULUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6316_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6316 NON-STANDARDIZED ALLERGENIC MUS MUSCULUS SKIN Mouse Epithelium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. MUS MUSCULUS SKIN 1000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6317_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6317 NON-STANDARDIZED ALLERGENIC ORRIS Orris Root INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ORRIS .05 g/mL 0268-6318_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6318 NON-STANDARDIZED ALLERGENIC PYRETHRUM CINERARIIFOLIUM Pyrethrum INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PYRETHRUM CINERARIIFOLIUM .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 0268-6319_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6319 NON-STANDARDIZED ALLERGENIC RABBIT Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. RABBIT 1000 [PNU]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 0268-6320_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6320 NON-STANDARDIZED ALLERGENIC RABBIT Rabbit Epithelium INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RABBIT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 0268-6400_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6400 NON-STANDARDIZED ALLERGENIC SOLENOPSIS INVICTA Fire Ant INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLENOPSIS INVICTA .01 g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6401_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6401 NON-STANDARDIZED ALLERGENIC SOLENOPSIS INVICTA Fire Ant INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. SOLENOPSIS INVICTA 10 [PNU]/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6402_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6402 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA American Cockroach INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA 100 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6403_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6403 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA American Cockroach INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6405_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6405 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA German Cockroach INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6407_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6407 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA German Cockroach INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA 100 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6500_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6500 NON-STANDARDIZED ALLERGENIC ACREMONIUM STRICTUM ACREMONIUM STRICTUM INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACREMONIUM STRICTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6501_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6501 NON-STANDARDIZED ALLERGENIC ACREMONIUM STRICTUM Acremonium Cephalosporium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ACREMONIUM STRICTUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6502_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6502 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS Alternaria tenuis A alternata INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6503_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6503 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS Alternaria tenuis A alternata INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6504_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6504 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS Aspergillus Fumigatus INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6506_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6506 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS Aspergillus Fumigatus INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6507_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6507 NON-STANDARDIZED ALLERGENIC ASPERGILLUS NIGER VAR NIGER Aspergillus Niger INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS NIGER VAR. NIGER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6508_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6508 NON-STANDARDIZED ALLERGENIC ASPERGILLUS NIGER VAR NIGER Aspergillus Niger INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS NIGER VAR. NIGER 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6509_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6509 NON-STANDARDIZED ALLERGENIC AUREOBASIDIUM PULLULANS VAR PULLULANS PULLULARIA PULLULANS INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6511_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6511 NON-STANDARDIZED ALLERGENIC AUREOBASIDIUM PULLULANS VAR PULLULANS Aureobasidium Pullularia Pullulans INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6512_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6512 NON-STANDARDIZED ALLERGENIC BOTRYTIS CINEREA Botrytis cinerea INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOTRYTIS CINEREA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6513_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6513 NON-STANDARDIZED ALLERGENIC BOTRYTIS CINEREA Botrytis cinerea INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. BOTRYTIS CINEREA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6514_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6514 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS Candida albicans INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS .1 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 0268-6515_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6515 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS Candida albicans INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS 1000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 0268-6516_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6516 NON-STANDARDIZED ALLERGENIC CHAETOMIUM GLOBOSUM Chaetomium globosum INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHAETOMIUM GLOBOSUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6517_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6517 NON-STANDARDIZED ALLERGENIC CHAETOMIUM GLOBOSUM Chaetomium globosum INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CHAETOMIUM GLOBOSUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6518_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6518 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES Cladosporium Cladosporioides Hormodendrum Clad INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6519_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6519 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES Cladosporium Cladosporioides Hormodendrum Clad INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6520_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6520 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM Cladosporium Sphaerospermum Hormodendrum Hordei INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6521_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6521 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM Cladosporium Sphaerospermum Hormodendrum Hordei INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6524_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6524 NON-STANDARDIZED ALLERGENIC COCHLIOBOLUS SATIVUS HELMINTHOSPORIUM SOROKINIANUM INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6525_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6525 NON-STANDARDIZED ALLERGENIC COCHLIOBOLUS SATIVUS Drechslera Helminthosporium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6526_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6526 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM Epicoccum nigrum INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM .1 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 0268-6528_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6528 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 1000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 0268-6529_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6529 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM Fusarium spp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6532_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6532 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM Fusarium spp INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6533_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6533 NON-STANDARDIZED ALLERGENIC HELMINTHOSPORIUM SOLANI Helminthosporium solani Spondylocladium INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HELMINTHOSPORIUM SOLANI .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6535_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6535 NON-STANDARDIZED ALLERGENIC HELMINTHOSPORIUM SOLANI Helminthosporium solani Spondylocladium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. HELMINTHOSPORIUM SOLANI 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6536_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6536 NON-STANDARDIZED ALLERGENIC MUCOR PLUMBEUS Mucor spp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUCOR PLUMBEUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6537_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6537 NON-STANDARDIZED ALLERGENIC MUCOR PLUMBEUS HelminthMucor spp INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. MUCOR PLUMBEUS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6538_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6538 NON-STANDARDIZED ALLERGENIC NEUROSPORA INTERMEDIA Neurospora spp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. NEUROSPORA INTERMEDIA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6539_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6539 NON-STANDARDIZED ALLERGENIC NEUROSPORA INTERMEDIA Neurospora spp INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. NEUROSPORA INTERMEDIA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6540_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6540 NON-STANDARDIZED ALLERGENIC KHUSKIA ORYZAE Nigrospora spp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. KHUSKIA ORYZAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6543_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6543 NON-STANDARDIZED ALLERGENIC PHOMA EXIGUA VAR EXIGUA Phoma herbarum INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PHOMA EXIGUA VAR. EXIGUA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6544_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6544 NON-STANDARDIZED ALLERGENIC PHOMA EXIGUA VAR EXIGUA Phoma herbarum INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. PHOMA EXIGUA VAR. EXIGUA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6545_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6545 NON-STANDARDIZED ALLERGENIC RHIZOPUS ARRHIZUS VAR ARRHIZUS Rhizopus spp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6547_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6547 NON-STANDARDIZED ALLERGENIC RHIZOPUS ARRHIZUS VAR ARRHIZUS Rhizopus spp INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6548_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6548 NON-STANDARDIZED ALLERGENIC RHODOTORULA RUBRA Rhodotorula Rubra INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHODOTORULA RUBRA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6549_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6549 NON-STANDARDIZED ALLERGENIC RHODOTORULA RUBRA Rhodotorula Rubra INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. RHODOTORULA RUBRA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6550_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6550 NON-STANDARDIZED ALLERGENIC USTILAGO MAYDIS Corn Smut INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. USTILAGO MAYDIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6552_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6552 NON-STANDARDIZED ALLERGENIC USTILAGO TRITICI Wheat Smut INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. USTILAGO TRITICI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6553_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6553 NON-STANDARDIZED ALLERGENIC STEMPHYLIUM SOLANI Stemphylium spp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. STEMPHYLIUM SOLANI .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6555_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6555 NON-STANDARDIZED ALLERGENIC STEMPHYLIUM SOLANI Stemphylium spp INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. STEMPHYLIUM SOLANI 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6556_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6556 NON-STANDARDIZED ALLERGENIC TRICHOPHYTON MENTAGROPHYTES Trichophyton Mentagrophytes INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRICHOPHYTON MENTAGROPHYTES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6557_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6557 NON-STANDARDIZED ALLERGENIC TRICHOPHYTON MENTAGROPHYTES Trichophyton Mentagrophytes INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. TRICHOPHYTON MENTAGROPHYTES 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6558_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6558 NON-STANDARDIZED ALLERGENIC PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM Yeast Saccharomyces cerevisiae INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6560_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6560 NON-STANDARDIZED ALLERGENIC SACCHAROMYCES CEREVISIAE Yeast Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. SACCHAROMYCES CEREVISIAE 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 0268-6600_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6600 NON-STANDARDIZED ALLERGENIC ACACIA Acacia INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACACIA .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6601_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6601 NON-STANDARDIZED ALLERGENIC ALNUS INCANA SSP RUGOSA POLLEN White Alder INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6602_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6602 NON-STANDARDIZED ALLERGENIC MEDICAGO SATIVA POLLEN Alfalfa INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MEDICAGO SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6603_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6603 NON-STANDARDIZED ALLERGENIC FRAXINUS AMERICANA POLLEN White Ash INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6605_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6605 NON-STANDARDIZED ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6606_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6606 NON-STANDARDIZED ALLERGENIC MORELLA CERIFERA POLLEN Bayberry Wax Myrtle INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORELLA CERIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6607_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6607 NON-STANDARDIZED ALLERGENIC FAGUS GRANDIFOLIA POLLEN Beech INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FAGUS GRANDIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6608_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6608 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Black Birch INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6609_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6609 NON-STANDARDIZED ALLERGENIC BETULA NIGRA POLLEN River Birch Red INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6610_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6610 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN White Birch INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6612_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6612 NON-STANDARDIZED ALLERGENIC ACER NEGUNDO POLLEN Box Elder Ash Leaf Maple INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER NEGUNDO POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6613_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6613 NON-STANDARDIZED ALLERGENIC AMARANTHUS PALMERI POLLEN Carelessweed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS PALMERI POLLEN .025 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6614_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6614 NON-STANDARDIZED ALLERGENIC JUNIPERUS ASHEI POLLEN Mountain Cedar INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6615_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6615 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Red Cedar INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6616_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6616 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6618_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6618 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES POLLEN Eastern Cottonwood Common INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6619_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6619 NON-STANDARDIZED ALLERGENIC CUPRESSUS ARIZONICA POLLEN Arizona Cypress INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CUPRESSUS ARIZONICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6620_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6620 NON-STANDARDIZED ALLERGENIC TAXODIUM DISTICHUM POLLEN Bald Cypress INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TAXODIUM DISTICHUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6621_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6621 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Sour Dock Sheep Sorrel INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 0268-6622_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6622 NON-STANDARDIZED ALLERGENIC RUMEX CRISPUS POLLEN Yellow Dock INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX CRISPUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6623_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6623 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN American Elm INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6625_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6625 NON-STANDARDIZED ALLERGENIC SOLIDAGO CANADENSIS POLLEN Goldenrod INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLIDAGO CANADENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6626_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6626 NON-STANDARDIZED ALLERGENIC CELTIS OCCIDENTALIS POLLEN Hackberry INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CELTIS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6627_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6627 NON-STANDARDIZED ALLERGENIC CARYA OVATA POLLEN Shagbark Hickory INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA OVATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6629_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6629 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6630_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6630 NON-STANDARDIZED ALLERGENIC JUNIPERUS CALIFORNICA POLLEN Western Juniper INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6631_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6631 NON-STANDARDIZED ALLERGENIC KOCHIA SCOPARIA POLLEN Kochia Firebush INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. KOCHIA SCOPARIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6632_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6632 NON-STANDARDIZED ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6634_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6634 NON-STANDARDIZED ALLERGENIC ACER RUBRUM POLLEN Red Maple INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER RUBRUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6635_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6635 NON-STANDARDIZED ALLERGENIC ACER SACCHARUM POLLEN Sugar Maple INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER SACCHARUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6636_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6636 NON-STANDARDIZED ALLERGENIC IVA XANTHIFOLIA POLLEN Burweed Marshelder INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. IVA XANTHIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6637_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6637 NON-STANDARDIZED ALLERGENIC IVA ANNUA VAR ANNUA POLLEN Rough Marshelder INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. IVA ANNUA VAR. ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6638_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6638 NON-STANDARDIZED ALLERGENIC PROSOPIS JULIFLORA POLLEN Mesquite INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PROSOPIS JULIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6639_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6639 NON-STANDARDIZED ALLERGENIC ARTEMISIA VULGARIS POLLEN Common Mugwort INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6640_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6640 NON-STANDARDIZED ALLERGENIC MORUS RUBRA POLLEN Red Mulberry INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6641_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6641 NON-STANDARDIZED ALLERGENIC MORUS ALBA POLLEN White Mulberry INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6642_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6642 NON-STANDARDIZED ALLERGENIC QUERCUS RUBRA POLLEN Red Oak INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6643_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6643 NON-STANDARDIZED ALLERGENIC QUERCUS VIRGINIANA POLLEN Virginia Live Oak INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6644_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6644 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN White Oak INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6646_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6646 NON-STANDARDIZED ALLERGENIC OLEA EUROPAEA POLLEN Olive Pollen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. OLEA EUROPAEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6647_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6647 NON-STANDARDIZED ALLERGENIC SYAGRUS ROMANZOFFIANA POLLEN Queen Palm Coco Palm INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SYAGRUS ROMANZOFFIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6648_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6648 NON-STANDARDIZED ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6649_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6649 NON-STANDARDIZED ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Rough Pigweed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6651_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6651 NON-STANDARDIZED ALLERGENIC PINUS STROBUS POLLEN White Pine INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS STROBUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6652_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6652 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN English Plantain INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6654_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6654 NON-STANDARDIZED ALLERGENIC POPULUS ALBA POLLEN White Poplar INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6656_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6656 NON-STANDARDIZED ALLERGENIC LIGUSTRUM VULGARE POLLEN Privet INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIGUSTRUM VULGARE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6657_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6657 NON-STANDARDIZED ALLERGENIC ELYMUS REPENS POLLEN Quack Grass INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ELYMUS REPENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6658_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6658 NON-STANDARDIZED ALLERGENIC AMBROSIA TRIFIDA POLLEN Tall Ragweed Giant INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TRIFIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6659_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6659 NON-STANDARDIZED ALLERGENIC SALSOLA KALI POLLEN Russian Thistle INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALSOLA KALI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6670_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6670 NON-STANDARDIZED ALLERGENIC ARTEMISIA TRIDENTATA POLLEN Common Sagebrush INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA TRIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6671_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6671 NON-STANDARDIZED ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6672_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6672 NON-STANDARDIZED ALLERGENIC PLATANUS OCCIDENTALIS POLLEN American Sycamore INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLATANUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6674_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6674 NON-STANDARDIZED ALLERGENIC JUGLANS NIGRA POLLEN Black Pollen Walnut INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6676_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6676 NON-STANDARDIZED ALLERGENIC ACACIA Acacia INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ACACIA 1000 [PNU]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6677_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6677 NON-STANDARDIZED ALLERGENIC AILANTHUS ALTISSIMA POLLEN Ailanthus Tree of Heaven INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AILANTHUS ALTISSIMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6678_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6678 NON-STANDARDIZED ALLERGENIC ALNUS INCANA SSP RUGOSA POLLEN White Alder INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6679_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6679 NON-STANDARDIZED ALLERGENIC FRAXINUS VELUTINA POLLEN Arizona Ash INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS VELUTINA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6680_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6680 NON-STANDARDIZED ALLERGENIC FRAXINUS AMERICANA POLLEN White Ash INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6681_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6681 NON-STANDARDIZED ALLERGENIC POPULUS TREMULOIDES POLLEN Aspen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS TREMULOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6682_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6682 NON-STANDARDIZED ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6683_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6683 NON-STANDARDIZED ALLERGENIC MORELLA CERIFERA POLLEN Bayberry Wax Myrtle INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. MORELLA CERIFERA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6684_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6684 NON-STANDARDIZED ALLERGENIC FAGUS GRANDIFOLIA POLLEN Beech INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. FAGUS GRANDIFOLIA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6686_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6686 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Black Birch INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6687_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6687 NON-STANDARDIZED ALLERGENIC BETULA NIGRA POLLEN River Birch Red INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA NIGRA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6688_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6688 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN White Birch INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6689_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6689 NON-STANDARDIZED ALLERGENIC POA ANNUA POLLEN Annual Bluegrass INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POA ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6690_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6690 NON-STANDARDIZED ALLERGENIC ACER NEGUNDO POLLEN Box Elder Ash Leaf Maple INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ACER NEGUNDO POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6691_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6691 NON-STANDARDIZED ALLERGENIC BROMUS INERMIS POLLEN Brome Grass INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6692_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6692 NON-STANDARDIZED ALLERGENIC BROMUS INERMIS POLLEN Brome Grass INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. BROMUS INERMIS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6693_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6693 NON-STANDARDIZED ALLERGENIC AMARANTHUS PALMERI POLLEN Carelessweed INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS PALMERI POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6694_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6694 NON-STANDARDIZED ALLERGENIC JUNIPERUS ASHEI POLLEN Mountain Cedar INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS ASHEI POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6695_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6695 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Red Cedar INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6696_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6696 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6697_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6697 NON-STANDARDIZED ALLERGENIC ZEA MAYS POLLEN Corn Pollen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ZEA MAYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6699_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6699 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES POLLEN Eastern Cottonwood Common INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6700_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6700 NON-STANDARDIZED ALLERGENIC POPULUS FREMONTII POLLEN Fremont Cottonwood INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS FREMONTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6701_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6701 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES SSP MONILIFERA POLLEN Western Cottonwood INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6702_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6702 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES SSP MONILIFERA POLLEN Western Cottonwood INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6703_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6703 NON-STANDARDIZED ALLERGENIC CUPRESSUS ARIZONICA POLLEN Arizona Cypress INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CUPRESSUS ARIZONICA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6704_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6704 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Sour Dock Sheep Sorrel INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 0268-6705_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6705 NON-STANDARDIZED ALLERGENIC RUMEX CRISPUS POLLEN Yellow Dock INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX CRISPUS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6706_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6706 NON-STANDARDIZED ALLERGENIC EUPATORIUM CAPILLIFOLIUM POLLEN Dog Fennel INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6707_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6707 NON-STANDARDIZED ALLERGENIC EUPATORIUM CAPILLIFOLIUM POLLEN Dog Fennel INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6708_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6708 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN American Elm INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6709_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6709 NON-STANDARDIZED ALLERGENIC ULMUS CRASSIFOLIA POLLEN Cedar Elm INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS CRASSIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6710_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6710 NON-STANDARDIZED ALLERGENIC ULMUS PUMILA POLLEN Chinese Elm INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS PUMILA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6711_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6711 NON-STANDARDIZED ALLERGENIC ULMUS PUMILA POLLEN Chinese Elm INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS PUMILA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6712_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6712 NON-STANDARDIZED ALLERGENIC EUCALYPTUS GLOBULUS POLLEN Eucalyptus INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EUCALYPTUS GLOBULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6713_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6713 NON-STANDARDIZED ALLERGENIC EUCALYPTUS GLOBULUS POLLEN Eucalyptus INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. EUCALYPTUS GLOBULUS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6714_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6714 NON-STANDARDIZED ALLERGENIC CORYLUS AMERICANA POLLEN Hazelnut Pollen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CORYLUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6715_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6715 NON-STANDARDIZED ALLERGENIC CORYLUS AMERICANA POLLEN Hazelnut Pollen INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CORYLUS AMERICANA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6716_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6716 NON-STANDARDIZED ALLERGENIC CARYA OVATA POLLEN Shagbark Hickory INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA OVATA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6717_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6717 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6719_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6719 NON-STANDARDIZED ALLERGENIC JUNIPERUS CALIFORNICA POLLEN Western Juniper INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS CALIFORNICA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6720_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6720 NON-STANDARDIZED ALLERGENIC KOCHIA SCOPARIA POLLEN Kochia Firebush INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. KOCHIA SCOPARIA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6721_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6721 NON-STANDARDIZED ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6722_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6722 NON-STANDARDIZED ALLERGENIC ROBINIA PSEUDOACACIA POLLEN Black Locust INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ROBINIA PSEUDOACACIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6723_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6723 NON-STANDARDIZED ALLERGENIC ROBINIA PSEUDOACACIA POLLEN Black Locust INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ROBINIA PSEUDOACACIA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6724_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6724 NON-STANDARDIZED ALLERGENIC ACER RUBRUM POLLEN Red Maple INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ACER RUBRUM POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6725_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6725 NON-STANDARDIZED ALLERGENIC ACER SACCHARUM POLLEN Sugar Maple INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ACER SACCHARUM POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6726_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6726 NON-STANDARDIZED ALLERGENIC IVA XANTHIFOLIA POLLEN Burweed Marshelder INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. IVA XANTHIFOLIA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6727_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6727 NON-STANDARDIZED ALLERGENIC IVA ANNUA VAR ANNUA POLLEN Rough Marshelder INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. IVA ANNUA VAR. ANNUA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6728_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6728 NON-STANDARDIZED ALLERGENIC MELALEUCA QUINQUENERVIA POLLEN Melaleuca Pollen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MELALEUCA QUINQUENERVIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6730_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6730 NON-STANDARDIZED ALLERGENIC PROSOPIS JULIFLORA POLLEN Mesquite INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. PROSOPIS JULIFLORA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6731_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6731 NON-STANDARDIZED ALLERGENIC CHENOPODIUM AMBROSIOIDES POLLEN Mexican Tea INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM AMBROSIOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6732_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6732 NON-STANDARDIZED ALLERGENIC ARTEMISIA VULGARIS POLLEN Common Mugwort INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA VULGARIS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6734_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6734 NON-STANDARDIZED ALLERGENIC MORUS RUBRA POLLEN Red Mulberry INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS RUBRA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6735_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6735 NON-STANDARDIZED ALLERGENIC MORUS ALBA POLLEN White Mulberry INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS ALBA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6736_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6736 NON-STANDARDIZED ALLERGENIC QUERCUS AGRIFOLIA POLLEN California Live Oak Coast INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS AGRIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6737_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6737 NON-STANDARDIZED ALLERGENIC QUERCUS AGRIFOLIA POLLEN California Live Oak Coast INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS AGRIFOLIA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6738_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6738 NON-STANDARDIZED ALLERGENIC QUERCUS RUBRA POLLEN Red Oak INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS RUBRA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6739_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6739 NON-STANDARDIZED ALLERGENIC QUERCUS VIRGINIANA POLLEN Virginia Live Oak INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS VIRGINIANA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6740_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6740 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN White Oak INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6741_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6741 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Wild Pollen Oat INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6743_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6743 NON-STANDARDIZED ALLERGENIC SCHINUS MOLLE POLLEN California Pepper Tree INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SCHINUS MOLLE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6744_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6744 NON-STANDARDIZED ALLERGENIC AMARANTHUS SPINOSUS POLLEN Spiny Pigweed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS SPINOSUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6745_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6745 NON-STANDARDIZED ALLERGENIC CASUARINA EQUISETIFOLIA POLLEN Australian Pine Beefwood INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CASUARINA EQUISETIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6748_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6748 NON-STANDARDIZED ALLERGENIC PINUS ECHINATA POLLEN Yellow Pine INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS ECHINATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6749_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6749 NON-STANDARDIZED ALLERGENIC AMBROSIA ACANTHICARPA POLLEN False Ragweed Bur INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ACANTHICARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6750_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6750 NON-STANDARDIZED ALLERGENIC AMBROSIA TENUIFOLIA POLLEN Slender Ragweed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TENUIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6751_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6751 NON-STANDARDIZED ALLERGENIC AMBROSIA BIDENTATA POLLEN Southern Ragweed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA BIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6752_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6752 NON-STANDARDIZED ALLERGENIC AMBROSIA PSILOSTACHYA POLLEN Western Ragweed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA PSILOSTACHYA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6754_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6754 NON-STANDARDIZED ALLERGENIC LOLIUM PERENNE SSP MULTIFLORUM POLLEN Italian Rye Grass INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6755_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6755 NON-STANDARDIZED ALLERGENIC ARTEMISIA FRIGIDA POLLEN Prairie Sage INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA FRIGIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6757_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6757 NON-STANDARDIZED ALLERGENIC DISTICHLIS SPICATA POLLEN Salt Grass INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. DISTICHLIS SPICATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6760_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6760 NON-STANDARDIZED ALLERGENIC HOLCUS LANATUS POLLEN Velvet Grass INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOLCUS LANATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6761_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6761 NON-STANDARDIZED ALLERGENIC JUGLANS NIGRA POLLEN California Walnut Black Pollen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6762_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6762 NON-STANDARDIZED ALLERGENIC JUGLANS REGIA POLLEN English Walnut Pollen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS REGIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6763_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6763 NON-STANDARDIZED ALLERGENIC TRITICUM AESTIVUM POLLEN Wheat Pollen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRITICUM AESTIVUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6764_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6764 NON-STANDARDIZED ALLERGENIC ARTEMISIA ANNUA POLLEN Common Wormwood Annual INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6771_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6771 NON-STANDARDIZED ALLERGENIC AMARANTHUS TUBERCULATUS POLLEN Water Hemp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS TUBERCULATUS POLLEN .025 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6772_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6772 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN White Pine INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .002 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6773_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6773 NON-STANDARDIZED ALLERGENIC OLEA EUROPAEA POLLEN Olive Pollen INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. OLEA EUROPAEA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6774_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6774 NON-STANDARDIZED ALLERGENIC SYAGRUS ROMANZOFFIANA POLLEN Queen Palm Coco Palm INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. SYAGRUS ROMANZOFFIANA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6775_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6775 NON-STANDARDIZED ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6776_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6776 NON-STANDARDIZED ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Rough Pigweed Redroot INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6777_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6777 NON-STANDARDIZED ALLERGENIC CASUARINA EQUISETIFOLIA POLLEN Australian Pine Beefwood INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CASUARINA EQUISETIFOLIA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6778_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6778 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN English Plantain INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6779_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6779 NON-STANDARDIZED ALLERGENIC POPULUS ALBA POLLEN White Poplar INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS ALBA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6780_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6780 NON-STANDARDIZED ALLERGENIC LIGUSTRUM VULGARE POLLEN Privet INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. LIGUSTRUM VULGARE POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6781_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6781 NON-STANDARDIZED ALLERGENIC AMBROSIA ACANTHICARPA POLLEN False Ragweed Bur INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ACANTHICARPA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6782_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6782 NON-STANDARDIZED ALLERGENIC AMBROSIA TRIFIDA POLLEN Tall Ragweed Giant INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TRIFIDA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6783_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6783 NON-STANDARDIZED ALLERGENIC AMBROSIA PSILOSTACHYA POLLEN Western Ragweed INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA PSILOSTACHYA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6784_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6784 NON-STANDARDIZED ALLERGENIC SALSOLA KALI POLLEN Russian Thistle INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. SALSOLA KALI POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6785_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6785 NON-STANDARDIZED ALLERGENIC ARTEMISIA FRIGIDA POLLEN Prairie Sage INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA FRIGIDA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6786_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6786 NON-STANDARDIZED ALLERGENIC ARTEMISIA TRIDENTATA POLLEN Common Sagebrush INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA TRIDENTATA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6787_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6787 NON-STANDARDIZED ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum Non Stock INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6788_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6788 NON-STANDARDIZED ALLERGENIC PLATANUS OCCIDENTALIS POLLEN American Sycamore INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. PLATANUS OCCIDENTALIS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6790_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6790 NON-STANDARDIZED ALLERGENIC HOLCUS LANATUS POLLEN Velvet Grass INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. HOLCUS LANATUS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6791_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6791 NON-STANDARDIZED ALLERGENIC JUGLANS NIGRA POLLEN Walnut Black Pollen INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6792_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6792 NON-STANDARDIZED ALLERGENIC JUGLANS NIGRA POLLEN California Walnut Black Pollen INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6793_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6793 NON-STANDARDIZED ALLERGENIC JUGLANS REGIA POLLEN English Walnut Pollen INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS REGIA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6794_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6794 NON-STANDARDIZED ALLERGENIC AMARANTHUS TUBERCULATUS POLLEN Water Hemp INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS TUBERCULATUS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6795_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6795 NON-STANDARDIZED ALLERGENIC TRITICUM AESTIVUM POLLEN Wheat Pollen INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. TRITICUM AESTIVUM POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-6796_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6796 NON-STANDARDIZED ALLERGENIC SALIX NIGRA POLLEN Black Willow INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-7000_0fbc190d-80b9-4c94-b8dc-637ae1c75366 0268-7000 HUMAN PRESCRIPTION DRUG Standardized Mite D. farinae Standardized Mite D. farinae SOLUTION PERCUTANEOUS 19910708 BLA BLA103060 ALK-Abello, Inc. DERMATOPHAGOIDES FARINAE 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0268-7001_0fbc190d-80b9-4c94-b8dc-637ae1c75366 0268-7001 HUMAN PRESCRIPTION DRUG Standardized Mite D. pteronyssinus Standardized Mite D. pteronyssinus SOLUTION PERCUTANEOUS 19900814 BLA BLA103752 ALK-Abello, Inc. DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 0270-0091_4e329c38-8a4f-171b-b5e7-a92b9fcf2eca 0270-0091 HUMAN PRESCRIPTION DRUG CardioGen-82 Rubidium Chloride RB-82 INJECTION, SOLUTION INTRAVENOUS 19891230 NDA NDA019414 Bracco Diagnostics Inc RUBIDIUM CHLORIDE RB-82 150 mCi/1 Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 0270-0149_e9b4f970-2df5-d316-7027-6499476b93b0 0270-0149 HUMAN PRESCRIPTION DRUG Cystografin diatrizoate meglumine INJECTION, SOLUTION INTRAVENOUS 19701103 NDA NDA010040 BRACCO DIAGNOSTICS INC DIATRIZOATE MEGLUMINE 300 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0270-0445_c0afca1c-73d2-1224-0684-682ca346e7bb 0270-0445 HUMAN PRESCRIPTION DRUG Gastrografin diatrizoate meglumine and diatrizoate sodium LIQUID ORAL; RECTAL 19580226 NDA NDA011245 Bracco Diagnostics Inc DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM 660; 100 mg/mL; mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0270-0556_fc40e13d-31f1-42df-93dd-6f4fb747c9c7 0270-0556 HUMAN PRESCRIPTION DRUG KINEVAC sincalide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19760721 NDA NDA017697 Bracco Diagnostics Inc. SINCALIDE 5 ug/5mL Cholecystokinin [Chemical/Ingredient],Cholecystokinin Analog [EPC] 0270-1111_20c27120-6600-4bfd-8701-45c551115005 0270-1111 HUMAN PRESCRIPTION DRUG ProHance gadoteridol INJECTION, SOLUTION INTRAVENOUS 19921116 NDA NDA020131 BRACCO DIAGNOSTICS INC. GADOTERIDOL 279.3 mg/mL Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0270-1111_b998ae4a-9a1d-d58a-0059-d943f0c32538 0270-1111 HUMAN PRESCRIPTION DRUG ProHance gadoteridol INJECTION, SOLUTION INTRAVENOUS 20031009 NDA NDA021489 Bracco Diagnostics Inc GADOTERIDOL 279.3 mg/mL Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0270-1314_5a893692-1fcd-3eec-a114-014adab53132 0270-1314 HUMAN PRESCRIPTION DRUG ISOVUE 200 IOPAMIDOL INJECTION, SOLUTION INTRAVASCULAR 19941012 NDA NDA018735 BRACCO DIAGNOSTICS INC IOPAMIDOL 408 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0270-1315_5a893692-1fcd-3eec-a114-014adab53132 0270-1315 HUMAN PRESCRIPTION DRUG ISOVUE 300 IOPAMIDOL INJECTION, SOLUTION INTRAVASCULAR 19941012 NDA NDA018735 BRACCO DIAGNOSTICS INC IOPAMIDOL 612 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0270-1315_797a11d7-dcd4-43ff-311b-3b48a10da2f2 0270-1315 HUMAN PRESCRIPTION DRUG ISOVUE 300 IOPAMIDOL INJECTION, SOLUTION INTRAVENOUS 19941012 NDA NDA020327 Bracco Diagnostics Inc IOPAMIDOL 612 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0270-1315_a7c9f3eb-7bcf-60d2-0e7c-e3b5a1d8ef96 0270-1315 HUMAN PRESCRIPTION DRUG ISOVUE 300 IOPAMIDOL INJECTION, SOLUTION INTRAVASCULAR 19941012 NDA NDA020327 Bracco Diagnostics Inc IOPAMIDOL 612 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0270-1316_5a893692-1fcd-3eec-a114-014adab53132 0270-1316 HUMAN PRESCRIPTION DRUG ISOVUE 370 IOPAMIDOL INJECTION, SOLUTION INTRAVASCULAR 19941012 NDA NDA018735 BRACCO DIAGNOSTICS INC IOPAMIDOL 755 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0270-1316_797a11d7-dcd4-43ff-311b-3b48a10da2f2 0270-1316 HUMAN PRESCRIPTION DRUG ISOVUE 370 IOPAMIDOL INJECTION, SOLUTION INTRAVENOUS 19941012 NDA NDA020327 Bracco Diagnostics Inc IOPAMIDOL 755 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0270-1316_a7c9f3eb-7bcf-60d2-0e7c-e3b5a1d8ef96 0270-1316 HUMAN PRESCRIPTION DRUG ISOVUE 370 IOPAMIDOL INJECTION, SOLUTION INTRAVASCULAR 19941012 NDA NDA020327 Bracco Diagnostics Inc IOPAMIDOL 755 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0270-1317_5a893692-1fcd-3eec-a114-014adab53132 0270-1317 HUMAN PRESCRIPTION DRUG ISOVUE 250 IOPAMIDOL INJECTION, SOLUTION INTRAVASCULAR 19941012 NDA NDA018735 BRACCO DIAGNOSTICS INC IOPAMIDOL 510 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0270-1317_a7c9f3eb-7bcf-60d2-0e7c-e3b5a1d8ef96 0270-1317 HUMAN PRESCRIPTION DRUG ISOVUE 250 IOPAMIDOL INJECTION, SOLUTION INTRAVASCULAR 19941012 NDA NDA020327 Bracco Diagnostics Inc IOPAMIDOL 510 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0270-1410_1997e06c-b0f7-b642-febc-c16835b848c4 0270-1410 HUMAN PRESCRIPTION DRUG Cystografin Dilute diatrizoate meglumine INJECTION, SOLUTION INTRAVESICAL 19821109 NDA NDA010040 BRACCO DIAGNOSTICS INC DIATRIZOATE MEGLUMINE 180 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0270-1411_a1fa6b9f-6f3f-4692-ab26-041e30552981 0270-1411 HUMAN PRESCRIPTION DRUG Isovue-M iopamidol INJECTION, SOLUTION INTRATHECAL 19851231 NDA NDA018735 Bracco Diagnostics Inc IOPAMIDOL 408 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0270-1412_a1fa6b9f-6f3f-4692-ab26-041e30552981 0270-1412 HUMAN PRESCRIPTION DRUG Isovue-M iopamidol INJECTION, SOLUTION INTRATHECAL 19851231 NDA NDA018735 Bracco Diagnostics Inc IOPAMIDOL 612 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0270-3876_bb8371e8-37e4-b891-ad57-e9d1af8314f5 0270-3876 HUMAN PRESCRIPTION DRUG MDP-Bracco Technetium Tc 99m Medronate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19810217 20150531 NDA NDA018107 Bracco Diagnostics Inc. TECHNETIUM TC-99M MEDRONATE 20 mg/1 Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 0270-5164_5e968d2a-ec71-431d-8b69-b6baef4c0312 0270-5164 HUMAN PRESCRIPTION DRUG MultiHance gadobenate dimeglumine INJECTION, SOLUTION INTRAVENOUS 20041123 NDA NDA021357 BRACCO DIAGNOSTICS INC GADOBENATE DIMEGLUMINE 529 mg/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] 0270-5264_b8ba67d4-f997-4c80-9b97-8001f6ca1103 0270-5264 HUMAN PRESCRIPTION DRUG MultiHance gadobenate dimeglumine INJECTION, SOLUTION INTRAVENOUS 20041123 NDA NDA021358 BRACCO DIAGNOSTICS INC GADOBENATE DIMEGLUMINE 529 mg/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] 0273-0241_5c095de2-9577-48d8-9c6d-34c9f7e90407 0273-0241 HUMAN PRESCRIPTION DRUG Oral B NeutraCare Mint Menthe Sodium Fluoride SOLUTION ORAL 20141123 UNAPPROVED DRUG OTHER YOUNG DENTAL MANUFACTURING CO 1, LLC SODIUM FLUORIDE .5 mg/g 0273-0341_42bbe6e4-a4b7-4dee-983d-f7e9dccd536a 0273-0341 HUMAN PRESCRIPTION DRUG Oral B Minute-Foam Mellow Mint Sodium Fluoride SOLUTION ORAL 20141123 UNAPPROVED DRUG OTHER YOUNG DENTAL MANUFACTURING CO 1, LLC SODIUM FLUORIDE 12.3 mg/g 0273-0342_42bbe6e4-a4b7-4dee-983d-f7e9dccd536a 0273-0342 HUMAN PRESCRIPTION DRUG Oral B Minute-Foam Orange-A-Tangy Sodium Fluoride SOLUTION ORAL 20141123 UNAPPROVED DRUG OTHER YOUNG DENTAL MANUFACTURING CO 1, LLC SODIUM FLUORIDE 12.3 mg/g 0273-0345_42bbe6e4-a4b7-4dee-983d-f7e9dccd536a 0273-0345 HUMAN PRESCRIPTION DRUG Oral B Minute-Foam Bubble Gum Sodium Fluoride SOLUTION ORAL 20141123 UNAPPROVED DRUG OTHER YOUNG DENTAL MANUFACTURING CO 1, LLC SODIUM FLUORIDE 12.3 mg/g 0273-0346_42bbe6e4-a4b7-4dee-983d-f7e9dccd536a 0273-0346 HUMAN PRESCRIPTION DRUG Oral B Minute-Foam Strawberry Sodium Fluoride SOLUTION ORAL 20141123 UNAPPROVED DRUG OTHER YOUNG DENTAL MANUFACTURING CO 1, LLC SODIUM FLUORIDE 12.3 mg/g 0273-0347_42bbe6e4-a4b7-4dee-983d-f7e9dccd536a 0273-0347 HUMAN PRESCRIPTION DRUG Oral B Minute-Foam Grape Sodium Fluoride SOLUTION ORAL 20141123 UNAPPROVED DRUG OTHER YOUNG DENTAL MANUFACTURING CO 1, LLC SODIUM FLUORIDE 12.3 mg/g 0273-0357_658364d8-fe2e-4bc1-8abb-db68a060e949 0273-0357 HUMAN PRESCRIPTION DRUG ZOOBY Spearmint Safari Sodium Fluoride AEROSOL, FOAM DENTAL 20100801 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC SODIUM FLUORIDE 2.72 g/100g 0273-0358_c288236a-9ea9-4ce1-984f-0ba8f80af973 0273-0358 HUMAN PRESCRIPTION DRUG ZOOBY Growlin Grrrape Sodium Fluoride AEROSOL, FOAM DENTAL 20100801 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC SODIUM FLUORIDE 2.72 g/100g 0273-0370_a473c7dd-3ad6-445d-8864-bde10103c1bc 0273-0370 HUMAN PRESCRIPTION DRUG ZOOBY Gator Gum Sodium Fluoride AEROSOL, FOAM DENTAL 20100801 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC SODIUM FLUORIDE 2.72 g/100g 0273-0392_569947be-56fb-4aab-8ed3-25dabfb81e20 0273-0392 HUMAN PRESCRIPTION DRUG ZOOBY Chocolate Chow Sodium Fluoride AEROSOL, FOAM DENTAL 20100801 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC SODIUM FLUORIDE 2.72 g/100g 0273-0393_10c9b613-79eb-46b9-85b4-434ee4fa8019 0273-0393 HUMAN PRESCRIPTION DRUG ZOOBY Happy Hippo Cake Sodium Fluoride AEROSOL, FOAM DENTAL 20100801 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC SODIUM FLUORIDE 2.72 g/100g 0273-0394_af65f399-593d-4476-8866-41efe4b1bba0 0273-0394 HUMAN PRESCRIPTION DRUG ZOOBY Turtle Melon Sodium Fluoride AEROSOL, FOAM DENTAL 20100801 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC SODIUM FLUORIDE 2.72 g/100g 0273-7001_bfd4b968-3454-45bb-9471-fda0a53c154e 0273-7001 HUMAN PRESCRIPTION DRUG Perfect Choice Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20060831 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. HYDROFLUORIC ACID; SODIUM FLUORIDE 4.4; 7.9 mg/g; mg/g 0273-7002_5f49df3b-a2f2-4715-8766-2f6e8cbba5be 0273-7002 HUMAN PRESCRIPTION DRUG Perfect Choice Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20060831 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. HYDROFLUORIC ACID; SODIUM FLUORIDE 4.4; 7.9 mg/g; mg/g 0273-7003_ab492507-24a5-4b58-af31-f23436eec789 0273-7003 HUMAN PRESCRIPTION DRUG Perfect Choice Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20060831 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. HYDROFLUORIC ACID; SODIUM FLUORIDE 4.4; 7.9 mg/g; mg/g 0273-7004_53e33736-042b-4e27-a370-55c0283e5400 0273-7004 HUMAN PRESCRIPTION DRUG Perfect Choice Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20060831 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. HYDROFLUORIC ACID; SODIUM FLUORIDE 4.4; 7.9 mg/g; g/g 0273-7005_efe4ed94-2fec-4c04-93c8-83eaa4c0c418 0273-7005 HUMAN PRESCRIPTION DRUG Perfect Choice Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20060831 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. HYDROFLUORIC ACID; SODIUM FLUORIDE 4.4; 7.9 mg/g; mg/g 0273-7006_2a9105fa-71d7-426b-8636-7c9d4c99eeac 0273-7006 HUMAN PRESCRIPTION DRUG Perfect Choice Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20060831 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. HYDROFLUORIC ACID; SODIUM FLUORIDE 4.4; 7.9 mg/g; mg/g 0273-7007_43a1b357-9b7e-4942-993d-4d27c0228a60 0273-7007 HUMAN PRESCRIPTION DRUG Perfect Choice Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20060831 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. HYDROFLUORIC ACID; SODIUM FLUORIDE 4.4; 7.9 mg/g; mg/g 0280-0030_0a57bb45-d4f8-443b-e054-00144ff8d46c 0280-0030 HUMAN OTC DRUG PHILLIPS ORIGINAL MILK OF MAGNESIA PHILLIPS ORIGINAL MILK OF MAGNESIA LIQUID ORAL 20141216 OTC MONOGRAPH NOT FINAL part334 Bayer HealthCare LLC, Consumer Care MAGNESIUM HYDROXIDE 1200 mg/15mL 0280-0031_0a59f9c3-c14f-2824-e054-00144ff8d46c 0280-0031 HUMAN OTC DRUG PHILLIPS FRESH MINT MILK OF MAGNESIA PHILLIPS FRESH MINT MILK OF MAGNESIA LIQUID ORAL 20141216 OTC MONOGRAPH NOT FINAL part334 Bayer HealthCare LLC, Consumer Care MAGNESIUM HYDROXIDE 1200 mg/15mL 0280-0032_0a6d824a-3d9b-07f9-e054-00144ff8d46c 0280-0032 HUMAN OTC DRUG Phillips Milk Of Magnesia Wild Cherry Phillips Milk Of Magnesia Wild Cherry LIQUID ORAL 20141217 OTC MONOGRAPH NOT FINAL part334 Bayer HealthCare LLC, Consumer Care MAGNESIUM HYDROXIDE 1200 mg/15mL 0280-0033_0a80bfdc-2658-50f8-e054-00144ff8d46c 0280-0033 HUMAN OTC DRUG Phillips Milk of Magnesia Concentrated Fresh Strawberry Phillips Milk of Magnesia Concentrated Fresh Strawberry LIQUID ORAL 20141218 OTC MONOGRAPH NOT FINAL part334 Bayer HealthCare LLC, Consumer Care MAGNESIUM HYDROXIDE 2400 mg/15mL 0280-0034_0965c4e1-492e-1ffe-e054-00144ff88e88 0280-0034 HUMAN OTC DRUG Phillips Chewable Phillips Chewable TABLET, CHEWABLE ORAL 20141204 OTC MONOGRAPH NOT FINAL part334 Bayer HealthCare Consumer Care MAGNESIUM HYDROXIDE 311 mg/1 0280-0052_890ad3da-4090-449b-ab4b-0ecb2dd4a597 0280-0052 HUMAN OTC DRUG Alka-Seltzer Plus Night Cold Formula (Lemon) Aspirin, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE BITARTRATE TABLET, EFFERVESCENT ORAL 20080430 OTC MONOGRAPH FINAL part341 Bayer HealthCare Consumer Care ASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE BITARTRATE 500; 10; 6.25; 7.8 mg/1; mg/1; mg/1; mg/1 0280-0221_f3dc7358-d33f-44da-9fcf-997f679cd6fc 0280-0221 HUMAN OTC DRUG Alka-Seltzer Heartburn ReliefChews CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20140315 OTC MONOGRAPH FINAL part331 Bayer HealthCare Consumer Care CALCIUM CARBONATE 750 mg/1 0280-0222_45366533-2978-4ec8-ba64-0ade2090a80f 0280-0222 HUMAN OTC DRUG Alka-Seltzer Heartburn ReliefChews Cool Mint CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20140315 OTC MONOGRAPH FINAL part331 Bayer HealthCare Consumer Care CALCIUM CARBONATE 750 mg/1 0280-0223_5adb1194-da8e-43e5-aff2-72e3ee63a67e 0280-0223 HUMAN OTC DRUG Alka-Seltzer Heartburn ReliefChews Strawberry CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20140315 OTC MONOGRAPH FINAL part331 Bayer HealthCare Consumer Care CALCIUM CARBONATE 750 mg/1 0280-0224_a13a9fc5-d6b4-4c4b-b247-0c46a148b826 0280-0224 HUMAN OTC DRUG Alka-Seltzer Heartburn ReliefChews Strawberry and Orange CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20140315 OTC MONOGRAPH FINAL part331 Bayer HealthCare Consumer Care CALCIUM CARBONATE 750 mg/1 0280-0225_dfc01caa-d0e0-4c9d-85ae-81b8cbc1c44b 0280-0225 HUMAN OTC DRUG Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical Punch CALCIUM CARBONATE AND SIMETHICONE TABLET, CHEWABLE ORAL 20140315 OTC MONOGRAPH FINAL part331 Bayer HealthCare Consumer Care CALCIUM CARBONATE; DIMETHICONE 750; 80 mg/1; mg/1 0280-0270_edc09ebd-d7df-4063-8add-2c137848b5cb 0280-0270 HUMAN OTC DRUG Menstridol NAPROXEN SODIUM TABLET ORAL 20140701 NDA NDA020204 Bayer HealthCare LLC, Consumer Care NAPROXEN SODIUM 220 mg/1 0280-0700_d04d152b-4532-4f58-8a64-55a92650f2e6 0280-0700 HUMAN OTC DRUG Bactine Original First Aid BENZALKONIUM CHLORIDE and LIDOCAINE HYDROCHLORIDE LIQUID TOPICAL 20020924 OTC MONOGRAPH NOT FINAL part333A Bayer HealthCare LLC, Consumer Care BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .13; 2.5 g/100mL; g/100mL 0280-0730_ad7b85f0-abfb-425e-b9f9-f361ca946486 0280-0730 HUMAN OTC DRUG Bactine Pain Relieving BENZALKONIUM CHLORIDE and LIDOCAINE HYDROCHLORIDE LIQUID TOPICAL 20020924 OTC MONOGRAPH NOT FINAL part333A Bayer HealthCare LLC, Consumer Care BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .13; 2.5 g/100mL; g/100mL 0280-0800_8e84992b-1f2d-4be9-9124-d21283d04fbf 0280-0800 HUMAN OTC DRUG Bronkaid Dual Action Formula EPHEDRINE SULFATE and GUAIFENESIN TABLET, COATED ORAL 20060101 OTC MONOGRAPH FINAL part341 Bayer HealthCare Consumer Care EPHEDRINE SULFATE; GUAIFENESIN 25; 400 mg/1; mg/1 0280-0915_987e1c86-009a-4fe8-9c79-3faa89d9676a 0280-0915 HUMAN OTC DRUG Neo-Synephrine Cold and Sinus Mild Strength Phenylephrine hydrochloride SPRAY NASAL 20140715 OTC MONOGRAPH FINAL part341 Bayer HealthCare Consumer Care PHENYLEPHRINE HYDROCHLORIDE .25 g/100mL 0280-0921_a6ae7e44-14cf-4b78-b2b8-c422c39c791c 0280-0921 HUMAN OTC DRUG Alka-Seltzer Plus Day Severe Cold Plus Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE POWDER, FOR SOLUTION ORAL 20140417 OTC MONOGRAPH FINAL part341 Bayer HealthCare Consumer Care ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 400; 10 mg/1; mg/1; mg/1; mg/1 0280-0922_3c947335-77fb-4d89-a554-363039b62fa2 0280-0922 HUMAN OTC DRUG Alka-Seltzer Plus Night Severe Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE POWDER, FOR SOLUTION ORAL 20140417 OTC MONOGRAPH FINAL part341 Bayer HealthCare Consumer Care ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/1; mg/1; mg/1; mg/1 0280-0923_0e81da10-2903-462a-a033-f24b8b09b17d 0280-0923 HUMAN OTC DRUG Alka-Seltzer Plus Severe Sinus and Cold ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE POWDER, FOR SOLUTION ORAL 20140417 OTC MONOGRAPH FINAL part341 Bayer HealthCare Consumer Care ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 4; 20; 10 mg/1; mg/1; mg/1; mg/1 0280-0924_9c386d6e-b532-4c3e-9e29-5be1e7b8822a 0280-0924 HUMAN OTC DRUG Alka-Seltzer Plus Day and Night Severe Cold and Flu Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, and Doxylamine succinate KIT 20140701 OTC MONOGRAPH FINAL part341 Bayer HealthCare Consumer Care 0280-0925_22eb79c7-ab85-4bbb-b028-d494f719da53 0280-0925 HUMAN OTC DRUG Neo-Synephrine Cold and Sinus Regular Strength Phenylephrine hydrochloride SPRAY NASAL 20140715 OTC MONOGRAPH FINAL part341 Bayer HealthCare Consumer Care PHENYLEPHRINE HYDROCHLORIDE .5 g/100mL 0280-0935_eba2789e-931f-4483-bc8e-e35be7f0bb50 0280-0935 HUMAN OTC DRUG Neo-Synephrine Cold and Sinus Extra Strength Phenylephrine hydrochloride SPRAY NASAL 20140715 OTC MONOGRAPH FINAL part341 Bayer HealthCare Consumer Care PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 0280-1001_11cca8a8-0e53-4890-b5f9-1cd0bf5e7d97 0280-1001 HUMAN OTC DRUG Alka-Seltzer Plus Max Cough, Mucus and Congestion Dextromethorphan hydrobromide and GUAIFENESIN CAPSULE, LIQUID FILLED ORAL 20130927 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC, Consumer Care DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/1; mg/1 0280-1012_db7e0ef8-cb4d-49ad-9483-75434152973c 0280-1012 HUMAN OTC DRUG Phillips Stool Softener Bulk Docusate Docusate sodium CAPSULE, LIQUID FILLED ORAL 20130902 OTC MONOGRAPH NOT FINAL part334 Bayer HealthCare LLC, Consumer Care DOCUSATE SODIUM 100 mg/1 0280-1121_229fd22e-a518-48d2-bc09-916bab0cd58a 0280-1121 HUMAN OTC DRUG Alka-Seltzer Plus Cold and Cough Formula ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC, Consumer Care ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 0280-1122_41d4fc84-ce16-47a3-9beb-c0afadc84ad7 0280-1122 HUMAN OTC DRUG Alka-Seltzer Plus Severe Sinus Congestion and Cough Day and Night Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, and Doxylamine succinate KIT 20131030 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC, Consumer Care 0280-1124_4c3c6260-0bc9-482a-be1d-49d07f63ba06 0280-1124 HUMAN OTC DRUG Alka-Seltzer Plus Night Cold and Flu Formula ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC, Consumer Care ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 0280-1125_871a683f-39ff-4831-a712-9fced1f3d68f 0280-1125 HUMAN OTC DRUG Alka-Seltzer Plus Severe Sinus Congestion, Allergy and Cough ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC, Consumer Care ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 0280-1126_100ed41c-bf10-4123-8662-a99d4a053df8 0280-1126 HUMAN OTC DRUG Alka-Seltzer Plus Day and Night Cold and Flu Formula Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, and Doxylamine succinate KIT 20131030 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC, Consumer Care 0280-1130_86fcfecb-547b-4fa6-9ab2-e459fd8572c0 0280-1130 HUMAN OTC DRUG Alka-Seltzer Plus Cold and Cough Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine maleate, and Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20110601 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC, Consumer Care ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 0280-1134_d9c37082-b1e7-4908-84c6-435d54f5a4ff 0280-1134 HUMAN OTC DRUG Alka-Seltzer Plus Day Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20130730 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC, Consumer Care ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 0280-1146_a43b06a3-3492-4df2-b04f-307267233275 0280-1146 HUMAN OTC DRUG Alka-Seltzer Plus Day and Night Multi-Symptom Cold and Flu Formula Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride and Doxylamine succinate KIT 20120530 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC, Consumer Care 0280-1155_80690033-09cb-4298-ad0c-a2b0d6cbf8b1 0280-1155 HUMAN OTC DRUG Alka-Seltzer Plus Day Severe Cold, Cough And Flu Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride POWDER ORAL 20120731 OTC MONOGRAPH FINAL part343 Bayer HealthCare LLC - Consumer Care ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 0280-1158_5b5c189d-aca6-487c-9d1b-7c36f1247559 0280-1158 HUMAN OTC DRUG Alka-Seltzer Plus Night Severe Cold, Cough And Flu Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride POWDER ORAL 20120731 OTC MONOGRAPH FINAL part343 Bayer HealthCare LLC - Consumer Care ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 0280-1159_d5292b72-8900-4eaf-96d7-5bc0eafc7113 0280-1159 HUMAN OTC DRUG Alka-Seltzer Plus Severe Cold, Mucus and Congestion Acetaminophen, Dextromethorphan hydrobromide, guaifenesin, and Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20130801 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC, Consumer Care ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 250; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 0280-1175_ede350c3-0bdb-4f25-8c2b-a886da1fddf5 0280-1175 HUMAN OTC DRUG Alka-Seltzer Plus Allergy Diphenhydramine Hydrochloride TABLET ORAL 20111107 OTC MONOGRAPH FINAL part336 Bayer HealthCare LLC, Consumer Care DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0280-1180_8b4b35eb-d7eb-44c4-94c2-efbe071d866a 0280-1180 HUMAN OTC DRUG Alka-Seltzer Plus Severe Sinus Congestion and Cough Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20101001 OTC MONOGRAPH FINAL part341 Bayer Corporation Consumer Care Division ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 0280-1186_cb0ffd36-edf7-479f-b0de-04f7ff999d38 0280-1186 HUMAN OTC DRUG Alka-Seltzer Plus Severe Sinus Congestion and Cough Day and Night Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, and Doxylamine succinate KIT 20120703 OTC MONOGRAPH FINAL part343 Bayer HealthCare LLC, Consumer Care 0280-1197_36bbbd59-b642-4b1f-b2de-4eef9d7ac06d 0280-1197 HUMAN OTC DRUG Alka-Seltzer Plus-D Multi-Symptom Sinus and Cold Acetaminophen, Dextromethorphan hydrobromide, chlorpheniramine maleate, and pseudoephedrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130801 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC, Consumer Care ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 325; 2; 10; 30 mg/1; mg/1; mg/1; mg/1 0280-1198_3b48f66e-a50e-48e7-9274-c826f2c5bf17 0280-1198 HUMAN OTC DRUG Alka-Seltzer Plus Severe Allergy Sinus Congestion And Headache Formula Acetaminophen, Doxylamine succinate, and Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20120801 OTC MONOGRAPH FINAL part343 Bayer HealthCare LLC, Consumer Care ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 0280-1200_5c27e4c6-2f86-4551-a027-18fec7ecc30f 0280-1200 HUMAN OTC DRUG Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM TABLET, FILM COATED ORAL 20140909 NDA NDA205352 Bayer HealthCare Consumer Care DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM 25; 220 mg/1; mg/1 0280-1400_5cd21432-c834-49af-aaaf-9241af611090 0280-1400 HUMAN OTC DRUG Alka-Seltzer Plus Cold Medicine Sparkling Original ASPIRIN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE BITARTRATE TABLET, EFFERVESCENT ORAL 20080410 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare Consumer Care ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 0280-1410_a076da72-adbd-4b9c-b3c3-a6bdd782466d 0280-1410 HUMAN OTC DRUG Alka-Seltzer Plus Day Non Drowsy Cold Medicine Citrus Aspirin, Dextromethorphan hydrobromide, and Phenylephrine bitartrate TABLET, EFFERVESCENT ORAL 20100801 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC, Consumer Care ASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE BITARTRATE 325; 10; 7.8 mg/1; mg/1; mg/1 0280-1415_53ba2a0a-c5bd-4549-a51d-b5c687ae4113 0280-1415 HUMAN OTC DRUG Alka-Seltzer Plus Day Non-Drowsy Cold and Flu Formula Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20120530 OTC MONOGRAPH FINAL part343 Bayer HealthCare LLC - Consumer Care ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 0280-1420_96dec32f-5254-4b36-af3a-bf63a1da814b 0280-1420 HUMAN OTC DRUG Alka-Seltzer Plus Cold and Cough Formula Aspirin, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE BITARTRATE TABLET, EFFERVESCENT ORAL 20080519 OTC MONOGRAPH FINAL part341 Bayer HealthCare Consumer Care ASPIRIN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE BITARTRATE 325; 2; 10; 7.8 mg/1; mg/1; mg/1; mg/1 0280-1430_297274bc-2bce-44ae-ad25-291ab2b9bbe9 0280-1430 HUMAN OTC DRUG Alka-Seltzer Plus Night Cold Medicine Aspirin, Doxylamine succinate, Phenylephrine bitartrate, and Dextromethorphan hydrobromide TABLET, EFFERVESCENT ORAL 20100801 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC, Consumer Care ASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE BITARTRATE 500; 10; 6.25; 7.8 mg/1; mg/1; mg/1; mg/1 0280-1435_9863be79-e7e8-485b-8e01-14fc724e4b32 0280-1435 HUMAN OTC DRUG Alka-Seltzer Plus Night Cold and Flu Formula Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, and Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20120530 OTC MONOGRAPH FINAL part343 Bayer HealthCare LLC - Consumer Care ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 0280-1440_5a12ce1d-ebe3-444b-b7e2-aab867ba20d7 0280-1440 HUMAN OTC DRUG Alka-Seltzer Plus Cold Formula (Orange Zest) Aspirin, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE BITARTRATE TABLET, EFFERVESCENT ORAL 20080410 OTC MONOGRAPH FINAL part341 Bayer HealthCare Consumer Care ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 0280-1460_86561121-b9a5-49de-8658-0ab1d8772609 0280-1460 HUMAN OTC DRUG Alka-Seltzer Plus Cold Formula (Cherry Burst) ASPIRIN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE BITARTRATE TABLET, EFFERVESCENT ORAL 20080410 OTC MONOGRAPH FINAL part341 Bayer HealthCare Consumer Care ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 0280-2000_ee45b500-6823-4d8c-a366-c2ca531473ed 0280-2000 HUMAN OTC DRUG Bayer Genuine Aspirin Aspirin TABLET ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare Consumer Care ASPIRIN 325 mg/1 0280-2020_0ae64cdb-4ea1-23af-e054-00144ff88e88 0280-2020 HUMAN OTC DRUG BAYER Aspirin Extra Strength Caplets BAYER Aspirin Extra Strength TABLET ORAL 20141223 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC, Consumer Care ASPIRIN 500 mg/1 0280-2030_a795ca00-6505-4c5d-a21b-0723ee8f99aa 0280-2030 HUMAN OTC DRUG Bayer Migraine Formula Acetaminophen, Aspirin, and Caffeine TABLET ORAL 20120626 ANDA ANDA075794 Bayer HealthCare LLC, Consumer Care ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0280-2090_070d5713-e019-2913-e054-00144ff8d46c 0280-2090 HUMAN OTC DRUG Bayer Chewable - Aspirin Regimen Low Dose Aspirin Cherry Flavored Aspirin TABLET, CHEWABLE ORAL 20020702 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC ASPIRIN 81 mg/1 0280-2100_071e067b-4642-3968-e054-00144ff8d46c 0280-2100 HUMAN OTC DRUG Bayer Low Dose Aspirin TABLET ORAL 20020712 OTC MONOGRAPH FINAL part343 Bayer HealthCare LLC, Consumer Care ASPIRIN 81 mg/1 0280-2500_f1db8522-3061-4d42-b333-c0f8aa9437c3 0280-2500 HUMAN OTC DRUG Bayer Fast Release Aspirin POWDER ORAL 20100630 OTC MONOGRAPH FINAL part341 Bayer Corporation Consumer Care Division ASPIRIN 500 mg/1 0280-2600_cf15286e-3787-4025-b895-277d70f6dac3 0280-2600 HUMAN OTC DRUG Bayer AM extra stength Aspirin and Caffeine TABLET ORAL 20100415 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC, Consumer Care ASPIRIN; CAFFEINE 500; 65 mg/1; mg/1 0280-2605_79e95988-2856-4c8f-acc7-695f622d69b6 0280-2605 HUMAN OTC DRUG Bayer Advanced Aspirin Regular Strength Aspirin TABLET ORAL 20101201 OTC MONOGRAPH FINAL part343 Bayer Corporation Consumer Care Division ASPIRIN 325 mg/1 0280-2610_6de24195-6fa5-428d-8aa2-ad4be9689ab7 0280-2610 HUMAN OTC DRUG Bayer Advanced Aspirin Extra Strength Aspirin TABLET ORAL 20121201 OTC MONOGRAPH FINAL part343 Bayer HealthCare LLC, Consumer Care ASPIRIN 500 mg/1 0280-2635_328e2d1e-22e0-49c1-bb3e-7eb162377cc2 0280-2635 HUMAN OTC DRUG Bayer Headache Relief Aspirin and Caffeine CAPSULE ORAL 20120601 OTC MONOGRAPH FINAL part343 Bayer HealthCare LLC ASPIRIN; CAFFEINE 500; 32.5 mg/1; mg/1 0280-4000_07d899a0-08d3-57b3-e054-00144ff88e88 0280-4000 HUMAN OTC DRUG Alka-Seltzer Original ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20100302 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare Consumer Care ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE 1000; 325; 1916 mg/1; mg/1; mg/1 0280-4020_07478020-5ba1-3b67-e054-00144ff88e88 0280-4020 HUMAN OTC DRUG Alka-Seltzer Lemon Lime Alka-Seltzer Lemon Lime TABLET, EFFERVESCENT ORAL 20141107 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare Consumer Care ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE 1000; 325; 1700 mg/1; mg/1; mg/1 0280-4035_8f02c76b-ef73-4214-8ee9-9e147a23a5b9 0280-4035 HUMAN OTC DRUG Alka-Seltzer XTRA STRENGTH Anhydrous Citric Acid, Sodium Bicarbonate, and Aspirin GRANULE, EFFERVESCENT ORAL 20100302 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC, Consumer Care ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE 1000; 500; 1985 mg/1; mg/1; mg/1 0280-4085_96edc1ed-e191-4d1f-89bb-0a43f3fef8d6 0280-4085 HUMAN OTC DRUG Alka-Seltzer HEARTBURN Anhydrous Citric Acid and Sodium Bicarbonate GRANULE, EFFERVESCENT ORAL 20100302 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC, Consumer Care ANHYDROUS CITRIC ACID; SODIUM BICARBONATE 1000; 1940 mg/1; mg/1 0280-4095_948d8e04-288a-44c7-b884-c1578690313a 0280-4095 HUMAN OTC DRUG Alka-Seltzer Fruit Chews calcium carbonate TABLET, CHEWABLE ORAL 20130315 OTC MONOGRAPH FINAL part331 Bayer HealthCare LLC, Consumer Care CALCIUM CARBONATE 750 mg/1 0280-4100_0824bedb-413c-2fa0-e054-00144ff88e88 0280-4100 HUMAN OTC DRUG Alka-Seltzer Gold Alka-Seltzer Gold TABLET, EFFERVESCENT ORAL 20141119 OTC MONOGRAPH FINAL part331 Bayer HealthCare Consumer Care CITRIC ACID MONOHYDRATE; POTASSIUM BICARBONATE; SODIUM BICARBONATE 1000; 344; 1050 mg/1; mg/1; mg/1 0280-6000_1c537709-b46c-4eda-bc75-f2dbe847c932 0280-6000 HUMAN OTC DRUG Aleve Caplets NAPROXEN SODIUM TABLET ORAL 20140226 NDA NDA020204 Bayer HealthCare LLC, Consumer Care NAPROXEN SODIUM 220 mg/1 0280-6010_1f1e2252-f884-4294-a0e5-6c4ea7d03c3d 0280-6010 HUMAN OTC DRUG Aleve NAPROXEN SODIUM TABLET ORAL 20020726 NDA NDA020204 Bayer HealthCare Consumer Care NAPROXEN SODIUM 220 mg/1 0280-6020_3d5a88b9-79c5-488a-ba87-212a67c8dd09 0280-6020 HUMAN OTC DRUG Aleve Gelcaps NAPROXEN SODIUM TABLET, COATED ORAL 20020801 NDA NDA020204 Bayer HealthCare Consumer Care NAPROXEN SODIUM 220 mg/1 0280-6050_bc0e61a4-3d0f-4d59-94c3-6893c01031a2 0280-6050 HUMAN OTC DRUG Aleve Caplets - Easy Open Arthritis Cap NAPROXEN SODIUM TABLET ORAL 20131111 NDA NDA020204 Bayer HealthCare Consumer Care NAPROXEN SODIUM 220 mg/1 0280-6060_85e22155-16c9-4339-a9d4-ceee4eefe356 0280-6060 HUMAN OTC DRUG Aleve Easy Open Arthritis Cap NAPROXEN SODIUM TABLET ORAL 20020726 NDA NDA020204 Bayer HealthCare Consumer Care NAPROXEN SODIUM 220 mg/1 0280-6070_1cb20ecc-b672-438e-b4d0-c799f00aee7e 0280-6070 HUMAN OTC DRUG Aleve Gelcaps NAPROXEN SODIUM TABLET, COATED ORAL 20020801 NDA NDA020204 Bayer HealthCare Consumer Care NAPROXEN SODIUM 220 mg/1 0280-6080_de7989f6-8ba5-44ae-b9e9-d1b9c60f7fbe 0280-6080 HUMAN OTC DRUG Aleve Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20070220 NDA NDA021920 Bayer HealthCare LLC, Consumer Care NAPROXEN SODIUM 220 mg/1 0280-6091_4b75bba3-e103-4210-ac7a-873b9a51aa38 0280-6091 HUMAN OTC DRUG Aleve Easy Open Arthritis Cap Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20070228 NDA NDA021920 Bayer HealthCare LLC, Consumer Care NAPROXEN SODIUM 220 mg/1 0280-7050_b8a3b5f3-2317-499f-9be4-e875bb96e6fa 0280-7050 HUMAN OTC DRUG Alka-Seltzer Plus Flu Formula Acetaminophen, Chlorpheniramine maleate, Phenylephrine Hydrochloride, and Dextromethorphan hydrobromide TABLET, EFFERVESCENT ORAL 20100801 OTC MONOGRAPH FINAL part341 Bayer Corporation Consumer Care Division ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 250; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 0280-7055_2b01853f-ffc2-41ab-90d3-5a8431699924 0280-7055 HUMAN OTC DRUG Alka-Seltzer Plus Severe Cold And Flu Formula Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine maleate, and Phenylephrine hydrochloride GRANULE, EFFERVESCENT ORAL 20120702 OTC MONOGRAPH FINAL part343 Bayer HealthCare LLC - Consumer Care ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 250; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 0280-7180_5c347d6d-c72b-4dd5-9a40-9c5e4a3e3116 0280-7180 HUMAN OTC DRUG Alka-Seltzer Plus Fast Crystals Packs Cold Formula Acetaminophen, Chlorpheniramine maleate, and Phenylephrine hydrochloride GRANULE, EFFERVESCENT ORAL 20090710 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC, Consumer Care ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 4; 10 mg/1; mg/1; mg/1 0280-7190_67c3f7fd-6ce6-4489-96a2-c1af17b3f51c 0280-7190 HUMAN OTC DRUG Alka-Seltzer Plus Fast Packs Cold and Flu Formula Acetaminophen, Chlorpheniramine maleate, and Phenylephrine Hydrochloride GRANULE, EFFERVESCENT ORAL 20100801 OTC MONOGRAPH FINAL part341 Bayer Corporation Consumer Care Division ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 4; 10 mg/1; mg/1; mg/1 0280-7190_c9bf8c6a-1008-42ce-a54c-220da619af3d 0280-7190 HUMAN OTC DRUG Alka-Seltzer Plus Fast Packs Cold and Flu Formula Acetaminophen, Chlorpheniramine maleate, and Phenylephrine Hydrochloride GRANULE, EFFERVESCENT ORAL 20100801 OTC MONOGRAPH FINAL part341 Bayer Corporation Consumer Care Division ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 4; 10 mg/1; mg/1; mg/1 0280-8005_bcd3f018-23c2-4e62-bd90-bb6bcd46880c 0280-8005 HUMAN OTC DRUG Midol Complete ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE TABLET ORAL 20140210 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC, Consumer Care ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 0280-8015_0a4477ce-0a03-197d-e054-00144ff88e88 0280-8015 HUMAN OTC DRUG Midol Complete Gelcaps Midol Complete TABLET, COATED ORAL 20141215 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC, Consumer Care ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 0280-8030_0733f148-0745-4bb3-e054-00144ff8d46c 0280-8030 HUMAN OTC DRUG Midol Teen Midol Teen TABLET, COATED ORAL 20030701 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC ACETAMINOPHEN; PAMABROM 500; 25 mg/1; mg/1 0280-8050_633aa599-e8ab-4a53-bc38-b22a183606f9 0280-8050 HUMAN OTC DRUG Midol Extended Relief Naproxen Sodium TABLET ORAL 20091020 NDA NDA020204 Bayer HealthCare LLC, Consumer Care NAPROXEN SODIUM 220 mg/1 0280-8070_09b9c5d8-c725-2bb4-e054-00144ff8d46c 0280-8070 HUMAN OTC DRUG Midol PM Midol PM TABLET, COATED ORAL 20141215 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 0280-8080_dfd413f2-1d69-4ed9-82f6-f80b928f1744 0280-8080 HUMAN OTC DRUG Midol Ibuprofen CAPSULE, LIQUID FILLED ORAL 20090518 NDA NDA021472 Bayer HealthCare LLC - Consumer Care IBUPROFEN 200 mg/1 0281-0326_f23fd03e-ba6b-4a2b-b362-6a41690b45ca 0281-0326 HUMAN PRESCRIPTION DRUG NITRO-BID Nitroglycerin OINTMENT TOPICAL 20090815 ANDA ANDA087355 Savage Laboratories a division of Fougera Pharmaceuticals Inc. NITROGLYCERIN 20 mg/g Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0281-0365_e4b895ab-8a6f-46b0-ad84-f4cae6158049 0281-0365 HUMAN PRESCRIPTION DRUG DigiFab ovine digoxin immune fab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010831 BLA BLA103910 SAVAGE LABORATORIES, A division of Nycomed US Inc. OVINE DIGOXIN IMMUNE FAB 38 mg/1 Immunoglobulin G [EPC],Digoxin Binding Activity [MoA],Immunoglobulins [Chemical/Ingredient] 0283-0293_77308ce2-f6a7-4546-b8e8-871d97633dd7 0283-0293 HUMAN OTC DRUG HurriCaine Topical Anesthetic Gel Benzocaine GEL DENTAL; ORAL; PERIODONTAL 19930215 OTC MONOGRAPH NOT FINAL part356 Beutlich LP, Pharmaceuticals BENZOCAINE 200 mg/g 0283-0569_302ec65a-4eb1-4e03-90f4-c23c13276a4e 0283-0569 HUMAN OTC DRUG HurriCaine Topical Anesthetic Liquid Benzocaine LIQUID DENTAL; ORAL; PERIODONTAL 19690515 OTC MONOGRAPH NOT FINAL part356 Beutlich LP, Pharmaceuticals BENZOCAINE 200 mg/g 0283-0610_18bdf860-f654-4072-a2af-0dfca4f4a730 0283-0610 HUMAN OTC DRUG HurriCaine Topical Anesthetic SPRAY DENTAL; ORAL; PERIODONTAL 20100615 OTC MONOGRAPH NOT FINAL part356 Beutlich Pharmaceuticals LLC BENZOCAINE 183 mg/g 0283-0679_030d24c0-db21-42d8-9985-0aa2e6225b4b 0283-0679 HUMAN OTC DRUG HurriCaine Topical Anesthetic Benzocaine SPRAY DENTAL; ORAL; PERIODONTAL 19790615 OTC MONOGRAPH NOT FINAL part356 Beutlich Pharmaceuticals, LLC BENZOCAINE 200 mg/g 0283-0808_e6b1907f-3a88-4d16-941a-cf635ca8640c 0283-0808 HUMAN OTC DRUG CEO-TWO Laxative SUPPOSITORY RECTAL 20080815 OTC MONOGRAPH NOT FINAL part334 Beutlich Pharmaceuticals, LLC POTASSIUM BITARTRATE; SODIUM BICARBONATE 927; 618 mg/3.7g; mg/3.7g 0283-0871_27e52e11-9d06-4dd6-a5a1-453a31ea3618 0283-0871 HUMAN OTC DRUG HurriCaine Topical Anesthetic Benzocaine GEL DENTAL; ORAL; PERIODONTAL 19710815 OTC MONOGRAPH NOT FINAL part356 Beutlich LP, Pharmaceuticals BENZOCAINE 200 mg/g 0283-0871_8be5b416-06df-4061-bff6-34be6b586d24 0283-0871 HUMAN OTC DRUG HurriCaine Topical Anesthetic Benzocaine GEL DENTAL; ORAL; PERIODONTAL 19710815 OTC MONOGRAPH NOT FINAL part356 Beutlich LP, Pharmaceuticals BENZOCAINE 200 mg/g 0283-0886_06ca84d4-abab-470e-98cd-a1b209951e43 0283-0886 HUMAN OTC DRUG HurriCaine Topical Anesthetic Gel Benzocaine GEL DENTAL; ORAL; PERIODONTAL 19860815 OTC MONOGRAPH NOT FINAL part356 Beutlich LP, Pharmaceuticals BENZOCAINE 200 mg/g 0283-0998_5cddcf58-7885-4907-9243-ee55254ceb4c 0283-0998 HUMAN OTC DRUG HurriCaine Topical Anesthetic Benzocaine GEL DENTAL; ORAL; PERIODONTAL 19980915 OTC MONOGRAPH NOT FINAL part356 Beutlich Pharmaceuticals LLC BENZOCAINE 200 mg/g 0283-1886_7d12ba96-4e1f-47e1-ac3b-aad728c05138 0283-1886 HUMAN OTC DRUG HurriCaine Topical Anesthetic Liquid Benzocaine LIQUID DENTAL; ORAL; PERIODONTAL 19860815 OTC MONOGRAPH NOT FINAL part356 Beutlich LP, Pharmaceuticals BENZOCAINE 200 mg/g 0288-1106_75d5beb2-d3d8-4e78-8df1-081095a53774 0288-1106 HUMAN PRESCRIPTION DRUG FLUORITAB CHEWABLE CHERRY SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20110109 UNAPPROVED DRUG OTHER Fluoritab Corporation SODIUM FLUORIDE .5 mg/1 0288-2203_2448eb27-df71-4bb1-814a-4766458a9505 0288-2203 HUMAN PRESCRIPTION DRUG FLUORITAB CHEWABLE CHERRY SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20110109 UNAPPROVED DRUG OTHER Fluoritab Corporation SODIUM FLUORIDE 1 mg/1 0288-5523_3a30ff5c-7903-465a-af66-21f0c24b5e3a 0288-5523 HUMAN PRESCRIPTION DRUG FLUORIDE DROPS SODIUM FLUORIDE LIQUID ORAL 20110109 UNAPPROVED DRUG OTHER Fluoritab Corporation SODIUM FLUORIDE 2.5 mg/mL 0295-1183_07851160-5cbe-4206-9455-36dbee16d474 0295-1183 HUMAN OTC DRUG Decolorized Iodine Iodides tincture LIQUID TOPICAL 19640701 OTC MONOGRAPH FINAL part331 Denison Pharmaceuticals, Inc. ALCOHOL .48 mL/mL 0295-1223_0cd64cba-f266-4875-b7ab-057d33ed854f 0295-1223 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 19790822 OTC MONOGRAPH FINAL part331 Denison Pharmaceuticals, Inc. BACITRACIN 500 [USP'U]/g 0299-2012_e7968460-c003-4a07-a7ce-729e4e61b64e 0299-2012 HUMAN PRESCRIPTION DRUG Vectical calcitriol OINTMENT TOPICAL 20090201 NDA NDA022087 Galderma Laboratories, L.P. CALCITRIOL 3 ug/g Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0299-3820_578810bb-a90d-43bd-8c02-c33bdcfea68a 0299-3820 HUMAN PRESCRIPTION DRUG METROGEL metronidazole GEL TOPICAL 20050630 NDA NDA021789 Galderma Laboratories, L.P. METRONIDAZOLE 10 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0299-3822_cf9019f7-4b23-4b1d-967e-d13d52cf4829 0299-3822 HUMAN PRESCRIPTION DRUG oracea doxycycline CAPSULE, DELAYED RELEASE ORAL 20100514 NDA NDA050805 Galderma Laboratories, L.P. DOXYCYCLINE 40 mg/1 0299-3836_a7ef3281-ba9c-874b-2021-635ffaf17776 0299-3836 HUMAN PRESCRIPTION DRUG MetroCream metronidazole CREAM TOPICAL 19950920 NDA NDA020531 Galderma Laboratories, L.P. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0299-3838_12ebabb0-074a-ca50-13ec-0c6ebca9d1d9 0299-3838 HUMAN PRESCRIPTION DRUG MetroLotion metronidazole LOTION TOPICAL 19981124 NDA NDA020901 Galderma Laboratories, L.P. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0299-3839_81928d4c-2ee7-4313-aa7a-2a228abcdd51 0299-3839 HUMAN PRESCRIPTION DRUG Rosanil sodium sulfacetamide, sulfer SOLUTION TOPICAL 20030131 UNAPPROVED DRUG OTHER Galderma Laboratories, L.P. SULFACETAMIDE; SULFUR 10; 5 g/100g; g/100g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0299-3847_5fe51e0d-1e86-49ce-855b-10bb75b91c45 0299-3847 HUMAN PRESCRIPTION DRUG Clobex clobetasol propionate SHAMPOO TOPICAL 20040301 NDA NDA021644 Galderma Laboratories, L.P. CLOBETASOL PROPIONATE .05 g/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0299-3848_9b1b5e9d-ff0c-4ab0-bddc-e339655af9db 0299-3848 HUMAN PRESCRIPTION DRUG Clobex Clobetasol Propionate LOTION TOPICAL 20030801 NDA NDA021535 Galderma Laboratories, L.P. CLOBETASOL PROPIONATE .05 g/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0299-3849_1433356b-8522-4fb2-892d-52b6137e1fde 0299-3849 HUMAN PRESCRIPTION DRUG CLOBEX clobetasol propionate SPRAY TOPICAL 20051027 NDA NDA021835 Galderma Laboratories, L.P. CLOBETASOL PROPIONATE .05 g/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0299-3913_855cde21-4291-4c1b-8e45-db2625184969 0299-3913 HUMAN OTC DRUG Cetaphil DermaControl SPF 30 octocrylene, octisalate, avobenzone LOTION TOPICAL 20111201 OTC MONOGRAPH FINAL part352 Galderma Laboratories, L.P. AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 7 mL/100mL; mL/100mL; mL/100mL 0299-3925_f83f9fc3-1a29-44af-8068-58bf537e0714 0299-3925 HUMAN OTC DRUG Cetaphil Gentle Cleansing Antibacterial Bar triclosan SOAP TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part333A Galderma Laboratories, L.P. TRICLOSAN .3 g/100g 0299-3928_24aab5c5-a3d2-409c-bbf8-9ab3f65658c2 0299-3928 HUMAN OTC DRUG Cetaphil octocrylene, avobenzone LOTION TOPICAL 20000401 OTC MONOGRAPH FINAL part352 Galderma Laboratories, L.P. AVOBENZONE; OCTOCRYLENE 3; 10 g/100mL; g/100mL 0299-3930_7c7c1cf1-baf4-4ea6-869f-fb8373eb83b9 0299-3930 HUMAN OTC DRUG Cetaphil Daily Facial Moisturizer SPF 50 octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide LOTION TOPICAL 20120101 OTC MONOGRAPH FINAL part352 Galderma Laboratories, L.P. OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 5; 7; 6; 5.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 0299-4500_c8aeebb5-99e8-4e76-bd7f-4a141c9ee371 0299-4500 HUMAN PRESCRIPTION DRUG Clindagel clindamycin phosphate GEL TOPICAL 20001127 20150701 NDA NDA050782 Galderma Laboratories, L.P. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0299-5500_3093997e-097a-df77-4e93-ea1cd3ebc539 0299-5500 HUMAN PRESCRIPTION DRUG Capex fluocinolone acetonide KIT 19841012 NDA NDA020001 Galderma Laboratories, L.P. 0299-5765_05d99fdf-f13a-964c-df62-f6f73c0df868 0299-5765 HUMAN PRESCRIPTION DRUG DesOwen desonide LOTION TOPICAL 19880715 ANDA ANDA072354 Galderma Laboratories, L.P. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0299-5770_05d99fdf-f13a-964c-df62-f6f73c0df868 0299-5770 HUMAN PRESCRIPTION DRUG DesOwen desonide CREAM TOPICAL 19841214 NDA NDA019048 Galderma Laboratories, L.P. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0299-5908_d7afd63b-3dcc-4a22-89a8-880a89b719a9 0299-5908 HUMAN PRESCRIPTION DRUG EPIDUO adapalene and benzoyl peroxide GEL TOPICAL 20081208 NDA NDA022320 Galderma Laboratories, L.P. ADAPALENE; BENZOYL PEROXIDE 1; 25 mg/g; mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0299-5910_79d4f186-a6fc-4fe5-9ca6-246c32317efd 0299-5910 HUMAN PRESCRIPTION DRUG DIFFERIN adapalene GEL TOPICAL 19960531 NDA NDA020380 Galderma Laboratories, L.P. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0299-5912_4e1b23c2-deab-4dff-864f-14b125fe15fd 0299-5912 HUMAN PRESCRIPTION DRUG Differin adapalene LOTION TOPICAL 20100331 NDA NDA022502 Galderma Laboratories, L.P. ADAPALENE .1 g/100mL Retinoid [EPC],Retinoids [Chemical/Ingredient] 0299-5915_49d3222c-eada-de37-78e5-ce32052a3871 0299-5915 HUMAN PRESCRIPTION DRUG Differin Adapalene CREAM TOPICAL 20091124 NDA NDA020748 GALDERMA LABORATORIES, L.P ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0299-5918_48887fea-27f4-4dc7-980b-cf80011f6675 0299-5918 HUMAN PRESCRIPTION DRUG DIFFERIN adapalene GEL TOPICAL 20090915 NDA NDA021753 Galderma Laboratories, L.P. ADAPALENE 3 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0299-5950_b3202a6a-964f-4db7-b77d-f738794adeb4 0299-5950 HUMAN PRESCRIPTION DRUG TRI-LUMA fluocinolone acetonide, hydroquinone, and tretinoin CREAM TOPICAL 20020118 NDA NDA021112 Galderma Laboratories, L.P. FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN .1; 40; .5 mg/g; mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Retinoid [EPC],Retinoids [Chemical/Ingredient] 0299-5980_712ca6fa-b7f5-4f25-89ab-9d9b5161c741 0299-5980 HUMAN PRESCRIPTION DRUG Mirvaso brimonidine tartrate GEL TOPICAL 20130823 NDA NDA204708 Galderma Laboratories, L.P. BRIMONIDINE TARTRATE 5 mg/g Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0299-6100_20237304-10de-4a50-92d9-c073c14a6568 0299-6100 HUMAN PRESCRIPTION DRUG PLIAGLIS lidocaine and tetracaine CREAM TOPICAL 20060629 NDA NDA021717 Galderma Laboratories, L.P. LIDOCAINE; TETRACAINE 70; 70 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 0310-0101_4ba4dffe-0ec0-462b-96a3-fdab78685968 0310-0101 HUMAN PRESCRIPTION DRUG TENORMIN Atenolol TABLET ORAL 19900901 NDA NDA018240 AstraZeneca Pharmaceuticals LP ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0310-0105_4ba4dffe-0ec0-462b-96a3-fdab78685968 0310-0105 HUMAN PRESCRIPTION DRUG TENORMIN Atenolol TABLET ORAL 19900901 NDA NDA018240 AstraZeneca Pharmaceuticals LP ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0310-0107_4ba4dffe-0ec0-462b-96a3-fdab78685968 0310-0107 HUMAN PRESCRIPTION DRUG TENORMIN Atenolol TABLET ORAL 19910201 NDA NDA018240 AstraZeneca Pharmaceuticals LP ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0310-0115_fe61473a-7ca4-44d7-9de1-1e83d820581a 0310-0115 HUMAN PRESCRIPTION DRUG TENORETIC Atenolol and Chlorthalidone TABLET ORAL 19900901 NDA NDA018760 AstraZeneca Pharmaceuticals LP ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0310-0117_fe61473a-7ca4-44d7-9de1-1e83d820581a 0310-0117 HUMAN PRESCRIPTION DRUG TENORETIC Atenolol and Chlorthalidone TABLET ORAL 19900901 NDA NDA018760 AstraZeneca Pharmaceuticals LP ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0310-0130_8ff30a43-8afa-45ec-a5f0-8e41246a08e7 0310-0130 HUMAN PRESCRIPTION DRUG ZESTRIL Lisinopril TABLET ORAL 20091111 NDA NDA019777 AstraZeneca Pharmaceuticals LP LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0310-0131_8ff30a43-8afa-45ec-a5f0-8e41246a08e7 0310-0131 HUMAN PRESCRIPTION DRUG ZESTRIL Lisinopril TABLET ORAL 20090828 NDA NDA019777 AstraZeneca Pharmaceuticals LP LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0310-0132_8ff30a43-8afa-45ec-a5f0-8e41246a08e7 0310-0132 HUMAN PRESCRIPTION DRUG ZESTRIL Lisinopril TABLET ORAL 20090513 NDA NDA019777 AstraZeneca Pharmaceuticals LP LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0310-0133_8ff30a43-8afa-45ec-a5f0-8e41246a08e7 0310-0133 HUMAN PRESCRIPTION DRUG ZESTRIL Lisinopril TABLET ORAL 20100922 NDA NDA019777 AstraZeneca Pharmaceuticals LP LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0310-0134_8ff30a43-8afa-45ec-a5f0-8e41246a08e7 0310-0134 HUMAN PRESCRIPTION DRUG ZESTRIL Lisinopril TABLET ORAL 20100326 NDA NDA019777 AstraZeneca Pharmaceuticals LP LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0310-0135_8ff30a43-8afa-45ec-a5f0-8e41246a08e7 0310-0135 HUMAN PRESCRIPTION DRUG ZESTRIL Lisinopril TABLET ORAL 20110902 NDA NDA019777 AstraZeneca Pharmaceuticals LP LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0310-0141_255bb026-ffbd-4194-a4fb-85a0ce76af8f 0310-0141 HUMAN PRESCRIPTION DRUG ZESTORETIC Lisinopril and Hydrochlorothiazide TABLET ORAL 20100615 NDA NDA019888 AstraZeneca Pharmaceuticals LP HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0310-0142_255bb026-ffbd-4194-a4fb-85a0ce76af8f 0310-0142 HUMAN PRESCRIPTION DRUG ZESTORETIC Lisinopril and Hydrochlorothiazide TABLET ORAL 20110509 NDA NDA019888 AstraZeneca Pharmaceuticals LP HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0310-0145_255bb026-ffbd-4194-a4fb-85a0ce76af8f 0310-0145 HUMAN PRESCRIPTION DRUG ZESTORETIC Lisinopril and Hydrochlorothiazide TABLET ORAL 20100727 NDA NDA019888 AstraZeneca Pharmaceuticals LP HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0310-0201_449d8fd6-abe2-4bc8-8bc9-67874ef86966 0310-0201 HUMAN PRESCRIPTION DRUG ARIMIDEX Anastrozole TABLET ORAL 19960116 NDA NDA020541 AstraZeneca Pharmaceuticals LP ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 0310-0208_6dd1a001-9fbb-4247-59ab-aa31e5283a05 0310-0208 HUMAN PRESCRIPTION DRUG ZOMIG Zolmitriptan SPRAY, METERED NASAL 20031020 NDA NDA021450 AstraZeneca Pharmaceuticals LP ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0310-0209_0caf812b-a1c7-4f82-d797-3d13071f7e80 0310-0209 HUMAN PRESCRIPTION DRUG ZOMIG ZMT Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20010402 NDA NDA021231 AstraZeneca Pharmaceuticals LP ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0310-0210_0caf812b-a1c7-4f82-d797-3d13071f7e80 0310-0210 HUMAN PRESCRIPTION DRUG ZOMIG Zolmitriptan TABLET ORAL 19980110 NDA NDA020768 AstraZeneca Pharmaceuticals LP ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0310-0211_0caf812b-a1c7-4f82-d797-3d13071f7e80 0310-0211 HUMAN PRESCRIPTION DRUG ZOMIG Zolmitriptan TABLET ORAL 19980110 NDA NDA020768 AstraZeneca Pharmaceuticals LP ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0310-0213_0caf812b-a1c7-4f82-d797-3d13071f7e80 0310-0213 HUMAN PRESCRIPTION DRUG ZOMIG ZMT Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20011001 NDA NDA021231 AstraZeneca Pharmaceuticals LP ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0310-0271_ac37e409-4b2b-4db7-86f6-3173c9410120 0310-0271 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 19971001 NDA NDA020639 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 0310-0272_ac37e409-4b2b-4db7-86f6-3173c9410120 0310-0272 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 19971001 NDA NDA020639 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 0310-0274_ac37e409-4b2b-4db7-86f6-3173c9410120 0310-0274 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20001113 NDA NDA020639 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 0310-0275_ac37e409-4b2b-4db7-86f6-3173c9410120 0310-0275 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20030630 NDA NDA020639 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 0310-0278_ac37e409-4b2b-4db7-86f6-3173c9410120 0310-0278 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20060213 NDA NDA020639 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 0310-0279_ac37e409-4b2b-4db7-86f6-3173c9410120 0310-0279 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20060213 NDA NDA020639 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 0310-0280_89481c58-8da5-4636-9f86-562768009d8f 0310-0280 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20090201 NDA NDA022047 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 0310-0281_89481c58-8da5-4636-9f86-562768009d8f 0310-0281 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20090201 NDA NDA022047 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] 0310-0282_89481c58-8da5-4636-9f86-562768009d8f 0310-0282 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20070716 NDA NDA022047 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 0310-0283_89481c58-8da5-4636-9f86-562768009d8f 0310-0283 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20070716 NDA NDA022047 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 0310-0284_89481c58-8da5-4636-9f86-562768009d8f 0310-0284 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20070716 NDA NDA022047 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 0310-0321_247bb5e2-dfb0-4a75-bca8-f4504c71937e 0310-0321 HUMAN PRESCRIPTION DRUG MERREM IV Meropenem INJECTION INTRAVENOUS 19960923 NDA NDA050706 AstraZeneca Pharmaceuticals LP MEROPENEM 1 g/30mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 0310-0325_247bb5e2-dfb0-4a75-bca8-f4504c71937e 0310-0325 HUMAN PRESCRIPTION DRUG MERREM IV Meropenem INJECTION INTRAVENOUS 19960923 NDA NDA050706 AstraZeneca Pharmaceuticals LP MEROPENEM 500 mg/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 0310-0401_2b0262a7-3717-4db6-8be7-f419812dda5f 0310-0401 HUMAN PRESCRIPTION DRUG ACCOLATE Zafirlukast TABLET, FILM COATED ORAL 19961001 NDA NDA020547 AstraZeneca Pharmaceuticals LP ZAFIRLUKAST 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0310-0402_2b0262a7-3717-4db6-8be7-f419812dda5f 0310-0402 HUMAN PRESCRIPTION DRUG ACCOLATE Zafirlukast TABLET, FILM COATED ORAL 19961001 NDA NDA020547 AstraZeneca Pharmaceuticals LP ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0310-0411_305566bf-f62c-4998-0497-8766c30db1b2 0310-0411 HUMAN PRESCRIPTION DRUG ZAFIRLUKAST Zafirlukast TABLET, FILM COATED ORAL 20101119 NDA NDA020547 AstraZeneca Pharmaceuticals LP ZAFIRLUKAST 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0310-0412_305566bf-f62c-4998-0497-8766c30db1b2 0310-0412 HUMAN PRESCRIPTION DRUG ZAFIRLUKAST Zafirlukast TABLET, FILM COATED ORAL 20101119 NDA NDA020547 AstraZeneca Pharmaceuticals LP ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0310-0482_05f93d0b-f393-478e-8f3f-e441c5ff687b 0310-0482 HUMAN PRESCRIPTION DRUG IRESSA Gefitinib TABLET, COATED ORAL 20030513 NDA NDA021399 AstraZeneca Pharmaceuticals LP GEFITINIB 250 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0310-0657_5e31a6a9-864f-4aba-8085-37ee1ddcd499 0310-0657 HUMAN PRESCRIPTION DRUG Lynparza olaparib CAPSULE ORAL 20141224 NDA NDA206162 AstraZeneca Pharmaceuticals LP OLAPARIB 50 mg/1 0310-0705_0f8dbdfb-d6d1-4f1b-ba69-d95546597d60 0310-0705 HUMAN PRESCRIPTION DRUG CASODEX Bicalutamide TABLET ORAL 19951016 NDA NDA020498 AstraZeneca Pharmaceuticals LP BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 0310-0720_95ee8ea3-40dc-472a-8d77-95e45aed7cd5 0310-0720 HUMAN PRESCRIPTION DRUG FASLODEX Fulvestrant INJECTION INTRAMUSCULAR 20101101 NDA NDA021344 AstraZeneca Pharmaceuticals LP FULVESTRANT 50 mg/mL Estrogen Receptor Antagonist [EPC],Estrogen Receptor Antagonists [MoA],Selective Estrogen Receptor Modulators [MoA] 0310-0751_3a498c46-5ad2-416a-875e-18e48b586954 0310-0751 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 AstraZeneca Pharmaceuticals LP ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0310-0752_3a498c46-5ad2-416a-875e-18e48b586954 0310-0752 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 AstraZeneca Pharmaceuticals LP ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0310-0754_3a498c46-5ad2-416a-875e-18e48b586954 0310-0754 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 AstraZeneca Pharmaceuticals LP ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0310-0755_3a498c46-5ad2-416a-875e-18e48b586954 0310-0755 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 AstraZeneca Pharmaceuticals LP ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0310-0950_b7188487-3137-43f3-8dfe-a414084dc2d6 0310-0950 HUMAN PRESCRIPTION DRUG ZOLADEX Goserelin acetate IMPLANT SUBCUTANEOUS 20030505 NDA NDA019726 AstraZeneca Pharmaceuticals LP GOSERELIN ACETATE 3.6 mg/1 Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] 0310-0951_b3a8fc1a-08a4-4291-a154-33b4b8ee184e 0310-0951 HUMAN PRESCRIPTION DRUG ZOLADEX Goserelin acetate IMPLANT SUBCUTANEOUS 20030505 NDA NDA020578 AstraZeneca Pharmaceuticals LP GOSERELIN ACETATE 10.8 mg/1 Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] 0310-1087_ddea171e-59a4-41af-aebc-f7cb995127e6 0310-1087 HUMAN PRESCRIPTION DRUG Dutoprol metoprolol succinate and hydrochlorothiazide TABLET, FILM COATED ORAL 20111230 NDA NDA021956 AstraZeneca Pharmaceuticals LP HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE 12.5; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0310-1095_ddea171e-59a4-41af-aebc-f7cb995127e6 0310-1095 HUMAN PRESCRIPTION DRUG Dutoprol metoprolol succinate and hydrochlorothiazide TABLET, FILM COATED ORAL 20111230 NDA NDA021956 AstraZeneca Pharmaceuticals LP HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE 12.5; 50 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0310-1097_ddea171e-59a4-41af-aebc-f7cb995127e6 0310-1097 HUMAN PRESCRIPTION DRUG Dutoprol metoprolol succinate and hydrochlorothiazide TABLET, FILM COATED ORAL 20111230 NDA NDA021956 AstraZeneca Pharmaceuticals LP HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE 12.5; 100 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0310-6100_c5116390-e0fe-4969-94cb-e9de5165fbab 0310-6100 HUMAN PRESCRIPTION DRUG ONGLYZA SAXAGLIPTIN TABLET, FILM COATED ORAL 20141120 NDA NDA022350 AstraZeneca Pharmaceuticals LP SAXAGLIPTIN HYDROCHLORIDE 2.5 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 0310-6105_c5116390-e0fe-4969-94cb-e9de5165fbab 0310-6105 HUMAN PRESCRIPTION DRUG ONGLYZA SAXAGLIPTIN TABLET, FILM COATED ORAL 20141120 NDA NDA022350 AstraZeneca Pharmaceuticals LP SAXAGLIPTIN HYDROCHLORIDE 5 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 0310-6125_fbd25da4-ebe6-45c9-beb8-93523d11a0b4 0310-6125 HUMAN PRESCRIPTION DRUG KOMBIGLYZE XR SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141204 NDA NDA200678 AstraZeneca Pharmaceuticals LP METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE 1000; 2.5 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0310-6250_ac8a0f7b-9f69-4495-abbc-3a47cd75a859 0310-6250 HUMAN PRESCRIPTION DRUG XIGDUO XR dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141114 NDA NDA205649 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0310-6260_ac8a0f7b-9f69-4495-abbc-3a47cd75a859 0310-6260 HUMAN PRESCRIPTION DRUG XIGDUO XR dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141114 NDA NDA205649 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 5; 1000 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0310-6270_ac8a0f7b-9f69-4495-abbc-3a47cd75a859 0310-6270 HUMAN PRESCRIPTION DRUG XIGDUO XR dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141114 NDA NDA205649 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 10; 500 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0310-6280_ac8a0f7b-9f69-4495-abbc-3a47cd75a859 0310-6280 HUMAN PRESCRIPTION DRUG XIGDUO XR dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141114 NDA NDA205649 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 10; 1000 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0310-6512_53d03c03-ebf7-418d-88a8-533eabd2ee4f 0310-6512 HUMAN PRESCRIPTION DRUG Byetta exenatide INJECTION SUBCUTANEOUS 20141210 NDA NDA021773 AstraZeneca Pharmaceuticals LP EXENATIDE 250 ug/mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] 0310-6524_53d03c03-ebf7-418d-88a8-533eabd2ee4f 0310-6524 HUMAN PRESCRIPTION DRUG Byetta exenatide INJECTION SUBCUTANEOUS 20141212 NDA NDA021773 AstraZeneca Pharmaceuticals LP EXENATIDE 250 ug/mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] 0310-6530_ebc3e0d0-c16a-474f-8bd2-f57ea64e9f33 0310-6530 HUMAN PRESCRIPTION DRUG BYDUREON exenatide INJECTION, SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 20140908 NDA NDA022200 AstraZeneca Pharmaceuticals LP EXENATIDE 2 mg/.65mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] 0310-7810_d1592dcf-a1ba-4c8d-50bf-c88126a930da 0310-7810 HUMAN PRESCRIPTION DRUG Vandetanib Vandetanib TABLET ORAL 20110421 NDA NDA022405 AstraZeneca Pharmaceuticals LP VANDETANIB 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0310-7820_cc6237ad-2ff7-4a29-a028-a41652466708 0310-7820 HUMAN PRESCRIPTION DRUG CAPRELSA Vandetanib TABLET ORAL 20110725 NDA NDA022405 AstraZeneca Pharmaceuticals LP VANDETANIB 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0310-7830_d1592dcf-a1ba-4c8d-50bf-c88126a930da 0310-7830 HUMAN PRESCRIPTION DRUG Vandetanib Vandetanib TABLET ORAL 20110421 NDA NDA022405 AstraZeneca Pharmaceuticals LP VANDETANIB 300 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0310-7840_cc6237ad-2ff7-4a29-a028-a41652466708 0310-7840 HUMAN PRESCRIPTION DRUG CAPRELSA Vandetanib TABLET ORAL 20110725 NDA NDA022405 AstraZeneca Pharmaceuticals LP VANDETANIB 300 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0311-0585_acf2f8d5-3582-4601-9ceb-dee438023b29 0311-0585 HUMAN OTC DRUG Almay Sensitive Skin Antiperspirant - Deodorant Roll-On Fragrance Free ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Almay, Inc ALUMINUM SESQUICHLOROHYDRATE .25 g/mL 0316-0126_d389954d-9312-4fd2-9a91-ac750124925f 0316-0126 HUMAN PRESCRIPTION DRUG Alacort Hydrocortisone CREAM TOPICAL 19730309 ANDA ANDA080706 Crown Laboratories HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0316-0140_fabe3bc4-a6d1-473c-b298-0bc17c4d615b 0316-0140 HUMAN PRESCRIPTION DRUG Ala Scalp Hydrocortisone Acetate LOTION TOPICAL 19730228 ANDA ANDA083231 Crown Laboratories HYDROCORTISONE ACETATE 20 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0316-0170_4c1c95f1-0ad8-4fbc-b80d-4ce99b6c4e53 0316-0170 HUMAN PRESCRIPTION DRUG Triderm Triamcinolone Acetonide CREAM TOPICAL 19840319 ANDA ANDA088042 Crown Laboratories TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0316-1005_eaaf8c06-6aac-4488-a4be-2f8912e30363 0316-1005 HUMAN PRESCRIPTION DRUG Dermasorb HC Complete Kit Hydrocortisone Lotion with Shampoo and Body Wash KIT TOPICAL 20131114 ANDA ANDA083231 Crown Laboratories 0316-1015_c6551aee-3d1b-4888-8311-5dc30f21547f 0316-1015 HUMAN PRESCRIPTION DRUG Dermasorb TA Complete Kit Triamcinolone Acetonide Cream with Emollient Cream KIT 20131114 ANDA ANDA088042 Crown Laboratories 0316-1025_87879f7f-edc8-42e7-8ca8-feebc31bcc29 0316-1025 HUMAN PRESCRIPTION DRUG Dermasorb AF Complete Kit Clioquinol and Hydrocortisone Cream with Hydrating Gel KIT TOPICAL 20131114 UNAPPROVED DRUG OTHER Crown Laboratories 0316-1035_95e5f86e-897b-4ef9-a514-6b003387f84c 0316-1035 HUMAN PRESCRIPTION DRUG Dermasorb XM Complete Kit Urea Cream with Moisturizing Cream KIT 20131114 UNAPPROVED DRUG OTHER Crown Laboratories 0316-2010_702d56b0-d5ab-49cc-a581-1eef70ba6fc6 0316-2010 HUMAN OTC DRUG Blue Lizard Regular Sunscreen LOTION TOPICAL 20010415 OTC MONOGRAPH FINAL part352 Crown Laboratories OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 76.5; 20.4; 30.6; 61.2 mg/mL; mg/mL; mg/mL; mg/mL 0316-2020_e1003e28-743b-4098-99f3-7cdc7f7efee8 0316-2020 HUMAN OTC DRUG Blue Lizard Sport Octinoxate, Octocrylene, Oxybenzone, and Zinc Oxide LOTION TOPICAL 20010415 OTC MONOGRAPH FINAL part352 Crown Laboratories OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 76.5; 20.4; 30.6; 61.2 mg/mL; mg/mL; mg/mL; mg/mL 0316-2035_b0b53658-4cbe-410c-9498-9e9709652ca8 0316-2035 HUMAN OTC DRUG Blue Lizard Baby Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20031208 OTC MONOGRAPH FINAL part352 Crown Laboratories TITANIUM DIOXIDE; ZINC OXIDE 54; 108 mg/mL; mg/mL 0316-2045_f8406afd-500a-44c2-844e-ba3c44ef1cc1 0316-2045 HUMAN OTC DRUG Blue Lizard Sensitive Sunscreen Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20031208 OTC MONOGRAPH FINAL part352 Crown Laboratories TITANIUM DIOXIDE; ZINC OXIDE 54; 108 mg/mL; mg/mL 0316-2055_a3d86213-8b5d-4f18-9cfc-92bf282ce4a8 0316-2055 HUMAN OTC DRUG Blue Lizard Face Sunscreen GEL TOPICAL 20100406 OTC MONOGRAPH NOT FINAL part352 Crown Laboratories OCTINOXATE; ZINC OXIDE 55; 80 mg/g; mg/g 0316-7400_b08ed252-9419-4781-ad45-04209f4afaf0 0316-7400 HUMAN PRESCRIPTION DRUG rea lo 40 urea CREAM TOPICAL 20060522 UNAPPROVED DRUG OTHER Crown Laboratories UREA 400 mg/g 0316-7401_b08ed252-9419-4781-ad45-04209f4afaf0 0316-7401 HUMAN PRESCRIPTION DRUG rea lo 40 urea LOTION TOPICAL 20060522 UNAPPROVED DRUG OTHER Crown Laboratories UREA 400 mg/mL 0316-7405_735e6799-8a15-4387-8a2c-6a966f130c73 0316-7405 HUMAN PRESCRIPTION DRUG rea lo 39 urea CREAM TOPICAL 20140901 UNAPPROVED DRUG OTHER Crown Laboratories UREA 390 mg/g 0322-2222_382926f5-2d08-421e-b8d2-acfeb45e14f2 0322-2222 HUMAN OTC DRUG Percy Medicine Bismuth Subsalicylate LIQUID ORAL 19200101 OTC MONOGRAPH FINAL part335 Merrick Medicine Company, Inc BISMUTH SUBSALICYLATE 1050 mg/10mL 0327-0001_6b3b2d67-4142-4a98-9a73-fb107b19a636 0327-0001 HUMAN OTC DRUG Clorpactin WCS-90 chlorine POWDER, FOR SOLUTION TOPICAL 19550101 UNAPPROVED DRUG OTHER United-Guardian, Inc. CHLORINE .16 g/2g 0327-0011_bdb3cef8-79c4-4322-9a21-c13123abe0cc 0327-0011 HUMAN PRESCRIPTION DRUG Renacidin citric acid, gluconolactone and magnesium carbonate SOLUTION IRRIGATION 19910101 NDA NDA019481 United-Guardian, Inc. ANHYDROUS CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE 6.6; .198; 3.376 g/100mL; g/100mL; g/100mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Calculi Dissolution Agent [EPC],Irrigation [MoA] 0338-0003_3fba913f-aac8-42e5-8439-0e94426af82d 0338-0003 HUMAN PRESCRIPTION DRUG Sterile Water Water IRRIGANT IRRIGATION 19800530 NDA NDA017866 Baxter Healthcare Corporation WATER 100 mL/100mL 0338-0004_2ba47d77-e661-48e2-a844-a2447e94daeb 0338-0004 HUMAN PRESCRIPTION DRUG STERILE WATER sterile water IRRIGANT IRRIGATION 19741231 NDA NDA017428 Baxter Healthcare Corporation WATER 100 mL/100mL 0338-0013_b91257f8-2f69-48f2-b7eb-d59796e6e762 0338-0013 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION, SOLUTION INTRAVENOUS 19820630 NDA NDA018632 Baxter Healthcare Company WATER 100 mL/100mL 0338-0013_c5ca76ea-aa7f-422e-8ec7-6e4e1cf5532c 0338-0013 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION, SOLUTION INTRAVENOUS 19820630 NDA NDA018632 Baxter Healthcare Company WATER 100 mL/100mL 0338-0017_7ee90a7e-d674-4171-8951-0936c0fcf55d 0338-0017 HUMAN PRESCRIPTION DRUG DEXTROSE DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19710304 NDA NDA016673 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 50 g/1000mL 0338-0023_7ee90a7e-d674-4171-8951-0936c0fcf55d 0338-0023 HUMAN PRESCRIPTION DRUG DEXTROSE DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19710125 NDA NDA016694 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 100 g/1000mL 0338-0031_b6a25d49-f74e-40ea-aad8-707902f87860 0338-0031 HUMAN PRESCRIPTION DRUG DEXTROSE Dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 19910702 NDA NDA020047 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 50 g/100mL 0338-0043_b054fb2f-e992-4bfd-9774-58baa0746ae2 0338-0043 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018016 Baxter Healthcare Corporation SODIUM CHLORIDE 4.5 g/1000mL 0338-0047_2cd66530-7d75-4627-9992-b6cb8ba4e3f0 0338-0047 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride IRRIGANT IRRIGATION 19800530 NDA NDA017867 Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL 0338-0047_6ffac585-bc47-4938-aa5c-415cf5283aca 0338-0047 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride IRRIGANT IRRIGATION 19800530 NDA NDA017867 Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL 0338-0048_bbaa6089-9863-4622-9c21-d7ded206e45a 0338-0048 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride IRRIGANT IRRIGATION 19741231 NDA NDA017427 Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL 0338-0049_b054fb2f-e992-4bfd-9774-58baa0746ae2 0338-0049 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19701209 NDA NDA016677 Baxter Healthcare Corporation SODIUM CHLORIDE 9 g/1000mL 0338-0050_0351926d-46d2-4c46-a4ff-22af798b265b 0338-0050 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride SOLUTION EXTRACORPOREAL 19800530 NDA NDA017867 Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL 0338-0051_b60fc8f8-9df2-461d-9442-c0892b1efea6 0338-0051 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride IRRIGANT IRRIGATION 19850517 NDA NDA019319 Baxter Healthcare Corporation SODIUM CHLORIDE 9 g/1000mL 0338-0054_d968f31c-fd6f-4f4d-81b9-442cfbbfe116 0338-0054 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19831101 NDA NDA019022 Baxter Healthcare Corporation SODIUM CHLORIDE 3 g/100mL 0338-0056_d968f31c-fd6f-4f4d-81b9-442cfbbfe116 0338-0056 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19831101 NDA NDA019022 Baxter Healthcare Corporation SODIUM CHLORIDE 5 g/100mL 0338-0073_61fc03bc-93f8-4407-a3ff-2446ca140c5f 0338-0073 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride Dextrose and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19710322 NDA NDA016697 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 2.5; 450 g/100mL; mg/100mL 0338-0077_61fc03bc-93f8-4407-a3ff-2446ca140c5f 0338-0077 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride Dextrose and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19701208 NDA NDA016689 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; 200 g/100mL; mg/100mL 0338-0081_61fc03bc-93f8-4407-a3ff-2446ca140c5f 0338-0081 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride Dextrose and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19710322 NDA NDA016687 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; 330 g/100mL; mg/100mL 0338-0085_61fc03bc-93f8-4407-a3ff-2446ca140c5f 0338-0085 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride Dextrose and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19710322 NDA NDA016683 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; 450 g/100mL; mg/100mL 0338-0089_61fc03bc-93f8-4407-a3ff-2446ca140c5f 0338-0089 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride Dextrose and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19701209 NDA NDA016678 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; 900 g/100mL; mg/100mL 0338-0095_61fc03bc-93f8-4407-a3ff-2446ca140c5f 0338-0095 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride Dextrose and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19710322 NDA NDA016696 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 10; 900 g/100mL; mg/100mL 0338-0104_e56135c4-59d8-41f2-8bec-b4048688aed7 0338-0104 HUMAN PRESCRIPTION DRUG Ringers sodium chloride, calcium chloride, potassium chloride, IRRIGANT IRRIGATION 19820219 NDA NDA018495 Baxter Healthcare Corporation CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 33; 30; 860 mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0105_7c2d5806-0dd7-4d59-b4c3-87b052567d9d 0338-0105 HUMAN PRESCRIPTION DRUG Ringers Sodium Chloride, Calcium Chloride, Potassium Chloride INJECTION INTRAVENOUS 19710322 NDA NDA016693 Baxter Healthcare Corporation CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE .33; .3; 8.6 g/1000mL; g/1000mL; g/1000mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0114_f09f80bf-2f8b-4420-865d-aec2d5e5cd4d 0338-0114 HUMAN PRESCRIPTION DRUG Lactated Ringers sodium chloride, sodium lactate, potassium chloride, calcium chloride IRRIGANT IRRIGATION 19820219 NDA NDA018494 Baxter Healthcare Corporation CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20; 30; 600; 310 mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-0117_89be82de-4d68-4449-8da5-21e5dda26d13 0338-0117 HUMAN PRESCRIPTION DRUG Lactated Ringers Sodium chloride, potassium chloride, sodium lactate and calcium chloride INJECTION, SOLUTION INTRAVENOUS 19710322 NDA NDA016682 Baxter Healthcare Corporation CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20; 30; 600; 310 mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-0118_aab8bc09-17c6-4ea1-8182-b1c70ce00919 0338-0118 HUMAN PRESCRIPTION DRUG Lactated Ringers Sodium Chloride, Sodium Lactate, Potassium Chloride and Calcium Chloride SOLUTION, FOR SLUSH IRRIGATION 19890829 NDA NDA019933 Baxter Healthcare Corporation CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE .2; .3; 6; 3.1 g/1000mL; g/1000mL; g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-0125_1e356eb8-814b-4822-979f-fbb637024fea 0338-0125 HUMAN PRESCRIPTION DRUG Lactated Ringers and Dextrose SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE and DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19710322 NDA NDA016679 Baxter Healthcare Corporation CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20; 5; 30; 600; 310 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-0129_14760f59-f64f-4884-9bb3-62d2a4ca3235 0338-0129 HUMAN PRESCRIPTION DRUG Sodium Lactate Sodium Lactate INJECTION, SOLUTION INTRAVENOUS 19710322 NDA NDA016692 Baxter Healthcare Corporation SODIUM LACTATE 1.87 g/100mL 0338-0137_597ef01a-1da1-4768-abd9-4f42b2fd8084 0338-0137 HUMAN PRESCRIPTION DRUG Lactated Ringers sodium chloride, soldium lactate, potassium chloride and calcium chloride IRRIGANT IRRIGATION 19840403 NDA NDA018921 Baxter Healthcare Corporation CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 200; 300; 6; 3.1 mg/1000mL; mg/1000mL; g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-0143_08f3ee1a-e2d6-4b1c-9a0e-9e56b2e6f650 0338-0143 HUMAN PRESCRIPTION DRUG Dextrose and Electrolyte No. 48 Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride and Dextrose monohydrate INJECTION INTRAVENOUS 19790202 NDA NDA017484 Baxter Healthcare Company DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE 5; 31; 141; 20; 12; 260 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0147_9950b0d5-7530-4059-a825-8771a7460259 0338-0147 HUMAN PRESCRIPTION DRUG PLASMA-LYTE 56 AND DEXTROSE dextrose monohydrate, sodium chloride, potassium acetate, magnesium acetate tetrahydrate INJECTION INTRAVENOUS 19790201 NDA NDA017385 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE 5; 32; 128; 224 g/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0338-0179_f1ed85db-9540-4c2e-a547-28beee16ac0b 0338-0179 HUMAN PRESCRIPTION DRUG Plasma-Lyte 148 SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA017378 Baxter Healthcare Corporation MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE 30; 37; 368; 526; 502 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0338-0190_534b85e0-04e7-4652-a948-244b9d382f7d 0338-0190 HUMAN PRESCRIPTION DRUG TIS-U-SOL sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate IRRIGANT IRRIGATION 19820219 NDA NDA018508 Baxter Healthcare Corporation MAGNESIUM SULFATE HEPTAHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 20; 40; 6.25; 800; 8.75 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0338-0221_a64a49f3-f45d-4fc8-9771-0472cbb06283 0338-0221 HUMAN PRESCRIPTION DRUG Plasma-Lyte A Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA017378 Baxter Healthcare Corporation MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE 30; 37; 368; 526; 502 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0338-0289_d08782ed-bcdc-49e2-bce3-0e757c4692b3 0338-0289 HUMAN PRESCRIPTION DRUG Glycine Glycine SOLUTION IRRIGATION 19800530 NDA NDA017865 Baxter Healthcare Corporation GLYCINE 1.5 g/100mL 0338-0295_d89b3598-0f3f-4e3b-b6db-aa4047caa8eb 0338-0295 HUMAN PRESCRIPTION DRUG Sorbitol Sorbitol IRRIGANT IRRIGATION 19800530 NDA NDA017863 Baxter Healthcare Corporation SORBITOL 30 g/1000mL 0338-0341_4a6f455a-3185-49e3-9696-df5fd25ca9ab 0338-0341 HUMAN PRESCRIPTION DRUG Cardioplegic Calcium Chloride, Magnesium Chloride, Potassium Chloride and Sodium Chloride SOLUTION INTRA-ARTERIAL 20000421 ANDA ANDA075323 Baxter Healthcare Corporation CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 17.6; 325.3; 119.3; 643 mg/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0351_57c99c24-bbd8-4b9d-b29c-67e2c2d7a049 0338-0351 HUMAN PRESCRIPTION DRUG Osmitrol Mannitol INJECTION, SOLUTION INTRAVENOUS 19640608 NDA NDA013684 Baxter Healthcare Corporation MANNITOL 5 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 0338-0353_57c99c24-bbd8-4b9d-b29c-67e2c2d7a049 0338-0353 HUMAN PRESCRIPTION DRUG Osmitrol Mannitol INJECTION, SOLUTION INTRAVENOUS 19640608 NDA NDA013684 Baxter Healthcare Corporation MANNITOL 10 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 0338-0355_57c99c24-bbd8-4b9d-b29c-67e2c2d7a049 0338-0355 HUMAN PRESCRIPTION DRUG Osmitrol Mannitol INJECTION, SOLUTION INTRAVENOUS 19640608 NDA NDA013684 Baxter Healthcare Corporation MANNITOL 15 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 0338-0357_57c99c24-bbd8-4b9d-b29c-67e2c2d7a049 0338-0357 HUMAN PRESCRIPTION DRUG Osmitrol Mannitol INJECTION, SOLUTION INTRAVENOUS 19640608 NDA NDA013684 Baxter Healthcare Corporation MANNITOL 20 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 0338-0409_5fb7c2b0-45b3-45d5-8cc5-588aa45fdeca 0338-0409 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Dextrose Lidocaine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19810422 NDA NDA018461 Baxter Healthcare Corporation LIDOCAINE HYDROCHLORIDE 4 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0338-0411_5fb7c2b0-45b3-45d5-8cc5-588aa45fdeca 0338-0411 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Dextrose Lidocaine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19810422 NDA NDA018461 Baxter Healthcare Corporation LIDOCAINE HYDROCHLORIDE 8 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0338-0431_46103157-0be5-4ded-9131-7b961efb1205 0338-0431 HUMAN PRESCRIPTION DRUG Heparin Sodium and Sodium Chloride HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19820428 NDA NDA018609 Baxter Healthcare Corporation HEPARIN SODIUM 200 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0338-0433_46103157-0be5-4ded-9131-7b961efb1205 0338-0433 HUMAN PRESCRIPTION DRUG Heparin Sodium and Sodium Chloride HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19820428 NDA NDA018609 Baxter Healthcare Corporation HEPARIN SODIUM 200 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0338-0439_16dabaa6-c9cb-429c-ba4d-e2ed6812e7d9 0338-0439 HUMAN PRESCRIPTION DRUG Theophylline in Dextrose Theophylline Anhydrous INJECTION, SOLUTION INTRAVENOUS 19820726 NDA NDA018649 Baxter Healthcare Corporation THEOPHYLLINE ANHYDROUS 80 mg/100mL 0338-0441_16dabaa6-c9cb-429c-ba4d-e2ed6812e7d9 0338-0441 HUMAN PRESCRIPTION DRUG Theophylline in Dextrose Theophylline Anhydrous INJECTION, SOLUTION INTRAVENOUS 19820726 NDA NDA018649 Baxter Healthcare Corporation THEOPHYLLINE ANHYDROUS 160 mg/100mL 0338-0499_d3b0b859-bc5a-4e88-8fe9-eb2abcde6b13 0338-0499 HUMAN PRESCRIPTION DRUG ProSol Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and Tyrosine INJECTION, SOLUTION INTRAVENOUS 19980826 NDA NDA020849 Baxter Healthcare Corporation ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 2.76; 1.96; 600; 1.02; 2.06; 1.18; 1.08; 1.08; 1.35; 760; 1; 1.34; 1.02; 980; 320; 50; 1.44 g/100mL; g/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-0502_4f347cf2-cf17-437e-b2eb-40d12c867aa3 0338-0502 HUMAN PRESCRIPTION DRUG Clinisol Lysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, Tyrosine INJECTION, SOLUTION INTRAVENOUS 19960830 ANDA ANDA020512 Baxter Healthcare Corporation ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960 g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-0503_0f1c5d9a-51ad-42c6-9801-fceba81831de 0338-0503 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate in Sodium Chloride Gentamicin Sulfate INJECTION, SOLUTION INTRAVENOUS 19820907 ANDA ANDA062373 Baxter Healthcare Corporation GENTAMICIN SULFATE 80 mg/100mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0338-0505_0f1c5d9a-51ad-42c6-9801-fceba81831de 0338-0505 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate in Sodium Chloride Gentamicin Sulfate INJECTION, SOLUTION INTRAVENOUS 19820907 ANDA ANDA062373 Baxter Healthcare Corporation GENTAMICIN SULFATE 100 mg/100mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0338-0507_0f1c5d9a-51ad-42c6-9801-fceba81831de 0338-0507 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate in Sodium Chloride Gentamicin Sulfate INJECTION, SOLUTION INTRAVENOUS 19820907 ANDA ANDA062373 Baxter Healthcare Corporation GENTAMICIN SULFATE 60 mg/50mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0338-0509_0f1c5d9a-51ad-42c6-9801-fceba81831de 0338-0509 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate in Sodium Chloride Gentamicin Sulfate INJECTION, SOLUTION INTRAVENOUS 19820907 ANDA ANDA062373 Baxter Healthcare Corporation GENTAMICIN SULFATE 80 mg/50mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0338-0511_0f1c5d9a-51ad-42c6-9801-fceba81831de 0338-0511 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate in Sodium Chloride Gentamicin Sulfate INJECTION, SOLUTION INTRAVENOUS 19820907 ANDA ANDA062373 Baxter Healthcare Corporation GENTAMICIN SULFATE 100 mg/50mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0338-0519_37566c56-cec9-4ec3-8952-0435f83959a5 0338-0519 HUMAN PRESCRIPTION DRUG Intralipid SOYBEAN OIL EMULSION INTRAVENOUS 20040401 NDA NDA018449 Baxter Healthcare Corporation SOYBEAN OIL 20 g/100mL 0338-0519_a32b806c-59e2-4c5a-bd65-305edc8ec7d0 0338-0519 HUMAN PRESCRIPTION DRUG Intralipid SOYBEAN OIL EMULSION INTRAVENOUS 20040401 NDA NDA020248 Baxter Healthcare Corporation SOYBEAN OIL 20 g/100mL 0338-0519_e17646b9-63ea-4420-998d-a742c3deb674 0338-0519 HUMAN PRESCRIPTION DRUG Intralipid SOYBEAN OIL EMULSION INTRAVENOUS 20130530 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SOYBEAN OIL 20 g/100mL 0338-0520_533873b0-2594-4a42-bfa5-0da0fdc730c9 0338-0520 HUMAN PRESCRIPTION DRUG Intralipid SOYBEAN OIL EMULSION INTRAVENOUS 20040401 NDA NDA019942 Baxter Healthcare Corporation SOYBEAN OIL 30 g/100mL 0338-0549_24b42d47-26ae-473f-b648-a4e65004f51e 0338-0549 HUMAN PRESCRIPTION DRUG Heparin Sodium in Dextrose HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20101231 NDA NDA018814 Baxter Healthcare Corporation HEPARIN SODIUM 4000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0338-0550_24b42d47-26ae-473f-b648-a4e65004f51e 0338-0550 HUMAN PRESCRIPTION DRUG Heparin Sodium in Dextrose HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20101231 NDA NDA018814 Baxter Healthcare Corporation HEPARIN SODIUM 5000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0338-0551_99019f44-4dec-44e0-9133-7db12576333d 0338-0551 HUMAN PRESCRIPTION DRUG Dextrose Dextrose Monohydrate INJECTION INTRAVENOUS 19921207 NDA NDA020179 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 5 g/100mL 0338-0552_24b42d47-26ae-473f-b648-a4e65004f51e 0338-0552 HUMAN PRESCRIPTION DRUG Heparin Sodium in Dextrose HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20101231 NDA NDA018814 Baxter Healthcare Corporation HEPARIN SODIUM 10000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0338-0553_82ad51cd-cf01-4ef7-bc50-bd539adcbb01 0338-0553 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAVENOUS 19921207 NDA NDA020178 Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL 0338-0603_268fe287-3c9f-4387-ab97-2d871e5cd3a9 0338-0603 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Potassium Chloride, Dextrose Monohydrate and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19820323 NDA NDA018629 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; 150; 330 g/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0644_03574a36-0578-4b8f-aeb2-3095ee6119a5 0338-0644 HUMAN PRESCRIPTION DRUG Travasol Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine INJECTION INTRAVENOUS 19840823 NDA NDA018931 Baxter Healthcare Corporation ALANINE; ARGININE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 2.07; 1.15; 1.03; 480; 600; 730; 580; 400; 560; 680; 500; 420; 180; 40; 580 g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-0656_5adcd7c3-d3c0-4fc3-af4b-6d9579fcea95 0338-0656 HUMAN PRESCRIPTION DRUG Acetic Acid Acetic Acid IRRIGANT IRRIGATION 19820219 NDA NDA018523 Baxter Healthcare Corporation ACETIC ACID 250 mg/100mL 0338-0663_268fe287-3c9f-4387-ab97-2d871e5cd3a9 0338-0663 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Potassium Chloride, Dextrose Monohydrate and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018037 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; 150; 200 g/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0669_268fe287-3c9f-4387-ab97-2d871e5cd3a9 0338-0669 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Potassium Chloride, Dextrose Monohydrate and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018008 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; 75; 450 g/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0671_268fe287-3c9f-4387-ab97-2d871e5cd3a9 0338-0671 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Potassium Chloride, Dextrose Monohydrate and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018008 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; 150; 450 g/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0673_268fe287-3c9f-4387-ab97-2d871e5cd3a9 0338-0673 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Potassium Chloride, Dextrose Monohydrate and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018008 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; 224; 450 g/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0675_268fe287-3c9f-4387-ab97-2d871e5cd3a9 0338-0675 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Potassium Chloride, Dextrose Monohydrate and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018008 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; 300; 450 g/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0681_d796171c-c769-402c-94e7-8cd0bcb88cd0 0338-0681 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose Potassium Chloride and Dextrose Monohydrate INJECTION, SOLUTION INTRAVENOUS 19790201 NDA NDA017634 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE 5; 75 g/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0683_d796171c-c769-402c-94e7-8cd0bcb88cd0 0338-0683 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose Potassium Chloride and Dextrose Monohydrate INJECTION, SOLUTION INTRAVENOUS 19790201 NDA NDA017634 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE 5; 150 g/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0685_d796171c-c769-402c-94e7-8cd0bcb88cd0 0338-0685 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose Potassium Chloride and Dextrose Monohydrate INJECTION, SOLUTION INTRAVENOUS 19790201 NDA NDA017634 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE 5; 224 g/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0687_d796171c-c769-402c-94e7-8cd0bcb88cd0 0338-0687 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose Potassium Chloride and Dextrose Monohydrate INJECTION, SOLUTION INTRAVENOUS 19790201 NDA NDA017634 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE 5; 300 g/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0691_5ab0219a-78af-4911-a982-1bafc97db420 0338-0691 HUMAN PRESCRIPTION DRUG Potassium Chloride in Sodium Chloride Potassium Chloride and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA017648 Baxter Healthcare Corporation POTASSIUM CHLORIDE; SODIUM CHLORIDE 150; 900 mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0695_5ab0219a-78af-4911-a982-1bafc97db420 0338-0695 HUMAN PRESCRIPTION DRUG Potassium Chloride in Sodium Chloride Potassium Chloride and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA017648 Baxter Healthcare Corporation POTASSIUM CHLORIDE; SODIUM CHLORIDE 300; 900 mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0703_33c0b37a-b236-4cd3-aa90-f14080aab9ff 0338-0703 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19891226 NDA NDA019904 Baxter Healthcare Corporation POTASSIUM CHLORIDE 29.8 g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0704_5ab0219a-78af-4911-a982-1bafc97db420 0338-0704 HUMAN PRESCRIPTION DRUG Potassium Chloride in Sodium Chloride Potassium Chloride and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA017648 Baxter Healthcare Corporation POTASSIUM CHLORIDE; SODIUM CHLORIDE 150; 450 mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0705_33c0b37a-b236-4cd3-aa90-f14080aab9ff 0338-0705 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19891226 NDA NDA019904 Baxter Healthcare Corporation POTASSIUM CHLORIDE 14.9 g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0707_33c0b37a-b236-4cd3-aa90-f14080aab9ff 0338-0707 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19891226 NDA NDA019904 Baxter Healthcare Corporation POTASSIUM CHLORIDE 22.4 g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0709_33c0b37a-b236-4cd3-aa90-f14080aab9ff 0338-0709 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19891226 NDA NDA019904 Baxter Healthcare Corporation POTASSIUM CHLORIDE 7.46 g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0719_a3a835de-06db-4505-8320-d32f341d61b9 0338-0719 HUMAN PRESCRIPTION DRUG Dextrose Dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 19790828 NDA NDA017521 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 70 g/100mL 0338-0719_b6a25d49-f74e-40ea-aad8-707902f87860 0338-0719 HUMAN PRESCRIPTION DRUG DEXTROSE Dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 19910702 NDA NDA020047 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 70 g/100mL 0338-0803_268fe287-3c9f-4387-ab97-2d871e5cd3a9 0338-0803 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Potassium Chloride, Dextrose Monohydrate and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19850405 NDA NDA019308 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; 150; 900 g/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0807_268fe287-3c9f-4387-ab97-2d871e5cd3a9 0338-0807 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Potassium Chloride, Dextrose Monohydrate and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19850405 NDA NDA019308 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 5; 300; 900 g/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0338-0811_14e57ddb-471a-4740-baef-451d53dccefe 0338-0811 HUMAN PRESCRIPTION DRUG Potassium Chloride in Lactated Ringers and Dextrose DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19850405 NDA NDA019367 Baxter Healthcare Corporation CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20; 5; 179; 600; 310 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-1005_6659383d-91ad-4969-a8a5-2baafc7a4f91 0338-1005 HUMAN PRESCRIPTION DRUG Dopamine Hydrochloride and Dextrose Dopamine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19870327 NDA NDA019615 Baxter Healthcare Corporation DOPAMINE HYDROCHLORIDE 80 mg/100mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0338-1007_6659383d-91ad-4969-a8a5-2baafc7a4f91 0338-1007 HUMAN PRESCRIPTION DRUG Dopamine Hydrochloride and Dextrose Dopamine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19870327 NDA NDA019615 Baxter Healthcare Corporation DOPAMINE HYDROCHLORIDE 160 mg/100mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0338-1009_6659383d-91ad-4969-a8a5-2baafc7a4f91 0338-1009 HUMAN PRESCRIPTION DRUG Dopamine Hydrochloride and Dextrose Dopamine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19870327 NDA NDA019615 Baxter Healthcare Corporation DOPAMINE HYDROCHLORIDE 320 mg/100mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0338-1013_3d2b24c4-199b-4745-a840-0b34f90abbe8 0338-1013 HUMAN PRESCRIPTION DRUG OXACILLIN OXACILLIN INJECTION, SOLUTION INTRAVENOUS 19891026 NDA NDA050640 Baxter Healthcare Corporation OXACILLIN SODIUM 1 g/50mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0338-1015_3d2b24c4-199b-4745-a840-0b34f90abbe8 0338-1015 HUMAN PRESCRIPTION DRUG OXACILLIN OXACILLIN INJECTION, SOLUTION INTRAVENOUS 19891026 NDA NDA050640 Baxter Healthcare Corporation OXACILLIN SODIUM 2 g/50mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0338-1017_6defafe9-cc0a-4978-806e-1a796c40a607 0338-1017 HUMAN PRESCRIPTION DRUG NAFCILLIN NAFCILLIN INJECTION, SOLUTION INTRAVENOUS 19891031 NDA NDA050655 Baxter Healthcare Corporation NAFCILLIN SODIUM 1 g/50mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0338-1019_6defafe9-cc0a-4978-806e-1a796c40a607 0338-1019 HUMAN PRESCRIPTION DRUG NAFCILLIN NAFCILLIN INJECTION, SOLUTION INTRAVENOUS 19891031 NDA NDA050655 Baxter Healthcare Corporation NAFCILLIN SODIUM 2 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0338-1021_df0ddc54-27ff-44bb-a38e-5fd4eeed1910 0338-1021 HUMAN PRESCRIPTION DRUG PENICILLIN G POTASSIUM PENICILLIN G INJECTION, SOLUTION INTRAVENOUS 19900625 NDA NDA050638 Baxter Healthcare Corporation PENICILLIN G POTASSIUM 1000000 [iU]/50mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0338-1023_df0ddc54-27ff-44bb-a38e-5fd4eeed1910 0338-1023 HUMAN PRESCRIPTION DRUG PENICILLIN G POTASSIUM PENICILLIN G INJECTION, SOLUTION INTRAVENOUS 19900625 NDA NDA050638 Baxter Healthcare Corporation PENICILLIN G POTASSIUM 2000000 [iU]/50mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0338-1025_df0ddc54-27ff-44bb-a38e-5fd4eeed1910 0338-1025 HUMAN PRESCRIPTION DRUG PENICILLIN G POTASSIUM PENICILLIN G INJECTION, SOLUTION INTRAVENOUS 19900625 NDA NDA050638 Baxter Healthcare Corporation PENICILLIN G POTASSIUM 3000000 [iU]/50mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0338-1047_1a4edcb8-2cee-47b1-a337-f8b9aac09737 0338-1047 HUMAN PRESCRIPTION DRUG Nitroglycerin In Dextrose Nitroglycerin INJECTION INTRAVENOUS 19891229 NDA NDA019970 Baxter Healthcare Company NITROGLYCERIN 10 mg/100mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0338-1049_1a4edcb8-2cee-47b1-a337-f8b9aac09737 0338-1049 HUMAN PRESCRIPTION DRUG Nitroglycerin In Dextrose Nitroglycerin INJECTION INTRAVENOUS 19891229 NDA NDA019970 Baxter Healthcare Company NITROGLYCERIN 20 mg/100mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0338-1051_1a4edcb8-2cee-47b1-a337-f8b9aac09737 0338-1051 HUMAN PRESCRIPTION DRUG Nitroglycerin In Dextrose Nitroglycerin INJECTION INTRAVENOUS 19891229 NDA NDA019970 Baxter Healthcare Company NITROGLYCERIN 40 mg/100mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0338-1055_9d0be69b-5193-4eb9-adca-25dd45806fc7 0338-1055 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole INJECTION, SOLUTION INTRAVENOUS 19811224 NDA NDA018657 Baxter Healthcare Corporation METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0338-1073_e2e34f01-681a-4cde-9ed4-103552946845 0338-1073 HUMAN PRESCRIPTION DRUG Dobutamine Hydrochloride in Dextrose Dobutamine Hydrochloride INJECTION INTRAVENOUS 19930927 NDA NDA020255 Baxter Healthcare Corporation DOBUTAMINE HYDROCHLORIDE 100 mg/100mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 0338-1075_e2e34f01-681a-4cde-9ed4-103552946845 0338-1075 HUMAN PRESCRIPTION DRUG Dobutamine Hydrochloride in Dextrose Dobutamine Hydrochloride INJECTION INTRAVENOUS 19930927 NDA NDA020255 Baxter Healthcare Corporation DOBUTAMINE HYDROCHLORIDE 200 mg/100mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 0338-1077_e2e34f01-681a-4cde-9ed4-103552946845 0338-1077 HUMAN PRESCRIPTION DRUG Dobutamine Hydrochloride in Dextrose Dobutamine Hydrochloride INJECTION INTRAVENOUS 19930923 NDA NDA020255 Baxter Healthcare Corporation DOBUTAMINE HYDROCHLORIDE 400 mg/100mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 0338-1083_0aa46f4c-e595-4301-bc42-c472d9cfe264 0338-1083 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 570; 316; 5; 283; 132; 165; 201; 159; 110; 154; 187; 138; 116; 50; 11; 160 mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1089_0aa46f4c-e595-4301-bc42-c472d9cfe264 0338-1089 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 880; 489; 5; 438; 204; 255; 311; 247; 170; 238; 289; 213; 179; 77; 17; 247 mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1091_0aa46f4c-e595-4301-bc42-c472d9cfe264 0338-1091 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 880; 489; 10; 438; 204; 255; 311; 247; 170; 238; 289; 213; 179; 77; 17; 247 mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1093_0aa46f4c-e595-4301-bc42-c472d9cfe264 0338-1093 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 880; 489; 20; 438; 204; 255; 311; 247; 170; 238; 289; 213; 179; 77; 17; 247 mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1095_0aa46f4c-e595-4301-bc42-c472d9cfe264 0338-1095 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 880; 489; 25; 438; 204; 255; 311; 247; 170; 238; 289; 213; 179; 77; 17; 247 mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1099_0aa46f4c-e595-4301-bc42-c472d9cfe264 0338-1099 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 1035; 575; 15; 515; 240; 300; 365; 290; 200; 280; 340; 250; 210; 90; 20; 290 mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1101_0aa46f4c-e595-4301-bc42-c472d9cfe264 0338-1101 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 1035; 575; 20; 515; 240; 300; 365; 290; 200; 280; 340; 250; 210; 90; 20; 290 mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1103_0aa46f4c-e595-4301-bc42-c472d9cfe264 0338-1103 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 1035; 575; 25; 515; 240; 300; 365; 290; 200; 340; 250; 210; 90; 20; 290 mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1107_8469d6fb-d6ef-476f-8cc3-0905192de0a8 0338-1107 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Ma INJECTION INTRAVENOUS 20110205 NDA NDA020678 Baxter Healthcare Corporation ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 570; 316; 33; 5; 283; 132; 165; 201; 159; 51; 110; 154; 261; 187; 138; 217; 112; 116; 50; 11; 160 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1109_8469d6fb-d6ef-476f-8cc3-0905192de0a8 0338-1109 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Ma INJECTION INTRAVENOUS 20110205 NDA NDA020678 Baxter Healthcare Corporation ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 570; 316; 33; 10; 283; 132; 165; 201; 159; 51; 110; 154; 261; 187; 138; 217; 112; 116; 50; 11; 160 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-1113_8469d6fb-d6ef-476f-8cc3-0905192de0a8 0338-1113 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Ma INJECTION INTRAVENOUS 20110205 NDA NDA020678 Baxter Healthcare Corporation ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 880; 489; 33; 5; 438; 204; 255; 311; 247; 51; 170; 238; 261; 289; 213; 297; 77; 179; 77; 17; 247 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-1115_8469d6fb-d6ef-476f-8cc3-0905192de0a8 0338-1115 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Ma INJECTION INTRAVENOUS 20110205 NDA NDA020678 Baxter Healthcare Corporation ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 880; 489; 33; 10; 438; 204; 255; 311; 247; 51; 170; 238; 261; 289; 213; 297; 77; 179; 77; 17; 247 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-1119_8469d6fb-d6ef-476f-8cc3-0905192de0a8 0338-1119 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Ma INJECTION INTRAVENOUS 20110205 NDA NDA020678 Baxter Healthcare Corporation ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 880; 489; 33; 25; 438; 204; 255; 311; 247; 51; 170; 238; 261; 289; 213; 297; 77; 179; 77; 17; 247 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-1123_8469d6fb-d6ef-476f-8cc3-0905192de0a8 0338-1123 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Ma INJECTION INTRAVENOUS 20110205 NDA NDA020678 Baxter Healthcare Corporation ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 1035; 575; 33; 15; 515; 240; 300; 365; 290; 51; 200; 280; 261; 340; 250; 340; 59; 210; 90; 20; 290 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-1125_8469d6fb-d6ef-476f-8cc3-0905192de0a8 0338-1125 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Ma INJECTION INTRAVENOUS 20110205 NDA NDA020678 Baxter Healthcare Corporation ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 1035; 575; 33; 20; 515; 240; 300; 365; 290; 51; 200; 280; 261; 340; 250; 340; 59; 210; 90; 20; 290 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-1127_8469d6fb-d6ef-476f-8cc3-0905192de0a8 0338-1127 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Ma INJECTION INTRAVENOUS 20110205 NDA NDA020678 Baxter Healthcare Corporation ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE, DL-; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 1035; 575; 33; 25; 515; 240; 300; 365; 290; 51; 200; 280; 261; 340; 250; 340; 59; 210; 90; 20; 290 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-1130_d70e8b14-bb74-43ce-9690-7ed9835b318b 0338-1130 HUMAN PRESCRIPTION DRUG Premasol - sulfite-free (Amino Acid) LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20030619 ANDA ANDA075880 Baxter Healthcare Corporation ALANINE; ARGININE; ASPARTIC ACID; CYSTEINE HYDROCHLORIDE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE .54; 1.2; .32; .016; .5; .36; .48; .82; 1.4; .82; .34; .48; .68; .38; 25; .42; .2; .24; .78 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1131_d70e8b14-bb74-43ce-9690-7ed9835b318b 0338-1131 HUMAN PRESCRIPTION DRUG Premasol - sulfite-free (Amino Acid) LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20030619 ANDA ANDA075880 Baxter Healthcare Corporation ALANINE; ARGININE; ASPARTIC ACID; CYSTEINE HYDROCHLORIDE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE .32; .73; .19; .014; .3; .22; .29; .49; .84; .49; .2; .29; .41; .23; 15; .25; .12; .14; .47 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1132_0aa46f4c-e595-4301-bc42-c472d9cfe264 0338-1132 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 570; 316; 5; 283; 132; 165; 201; 159; 110; 154; 187; 138; 116; 50; 11; 160 mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1133_0aa46f4c-e595-4301-bc42-c472d9cfe264 0338-1133 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 880; 489; 5; 438; 204; 255; 311; 247; 170; 238; 289; 213; 179; 77; 17; 247 mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1134_0aa46f4c-e595-4301-bc42-c472d9cfe264 0338-1134 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 880; 489; 10; 438; 204; 255; 311; 247; 170; 238; 289; 213; 179; 77; 17; 247 mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1135_0aa46f4c-e595-4301-bc42-c472d9cfe264 0338-1135 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 489; 20; 438; 204; 255; 311; 247; 170; 238; 289; 213; 179; 77; 17; 247 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL 0338-1136_0aa46f4c-e595-4301-bc42-c472d9cfe264 0338-1136 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 880; 489; 25; 438; 204; 255; 311; 247; 170; 238; 289; 213; 179; 77; 17; 247 mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1137_0aa46f4c-e595-4301-bc42-c472d9cfe264 0338-1137 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 1035; 575; 15; 515; 240; 300; 365; 290; 200; 280; 340; 250; 210; 90; 20; 290 mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1138_0aa46f4c-e595-4301-bc42-c472d9cfe264 0338-1138 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 1035; 575; 20; 515; 240; 300; 365; 290; 200; 280; 340; 250; 210; 90; 20; 290 mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1139_0aa46f4c-e595-4301-bc42-c472d9cfe264 0338-1139 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 1035; 575; 25; 515; 240; 300; 365; 290; 200; 280; 340; 250; 210; 90; 20; 290 mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0338-1142_8469d6fb-d6ef-476f-8cc3-0905192de0a8 0338-1142 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Ma INJECTION INTRAVENOUS 20110205 NDA NDA020678 Baxter Healthcare Corporation ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 570; 316; 33; 5; 283; 132; 165; 201; 159; 51; 110; 154; 261; 187; 138; 217; 112; 116; 50; 11; 160 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-1143_8469d6fb-d6ef-476f-8cc3-0905192de0a8 0338-1143 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Ma INJECTION INTRAVENOUS 20110205 NDA NDA020678 Baxter Healthcare Corporation ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 570; 316; 33; 10; 283; 132; 165; 201; 159; 51; 110; 154; 261; 187; 138; 217; 112; 116; 50; 11; 160 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-1144_8469d6fb-d6ef-476f-8cc3-0905192de0a8 0338-1144 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Ma INJECTION INTRAVENOUS 20110205 NDA NDA020678 Baxter Healthcare Corporation ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 880; 489; 33; 5; 438; 204; 255; 311; 247; 51; 170; 238; 261; 289; 213; 297; 77; 179; 77; 17; 247 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-1145_8469d6fb-d6ef-476f-8cc3-0905192de0a8 0338-1145 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Ma INJECTION INTRAVENOUS 20110205 NDA NDA020678 Baxter Healthcare Corporation ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 880; 489; 33; 10; 438; 204; 255; 311; 247; 51; 170; 238; 261; 289; 213; 297; 77; 179; 77; 17; 247 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-1146_8469d6fb-d6ef-476f-8cc3-0905192de0a8 0338-1146 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Ma INJECTION INTRAVENOUS 20110205 NDA NDA020678 Baxter Healthcare Corporation ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 880; 489; 33; 25; 438; 204; 255; 311; 247; 51; 170; 238; 261; 289; 213; 297; 77; 179; 77; 17; 247 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-1147_8469d6fb-d6ef-476f-8cc3-0905192de0a8 0338-1147 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Ma INJECTION INTRAVENOUS 20110205 NDA NDA020678 Baxter Healthcare Corporation ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 1035; 575; 33; 15; 515; 240; 300; 365; 290; 51; 200; 280; 261; 340; 250; 340; 59; 210; 90; 20; 290 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-1148_8469d6fb-d6ef-476f-8cc3-0905192de0a8 0338-1148 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Ma INJECTION INTRAVENOUS 20110205 NDA NDA020678 Baxter Healthcare Corporation ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; THREONINE; TYROSINE; VALINE 1035; 575; 33; 20; 515; 240; 300; 365; 290; 51; 200; 280; 261; 340; 250; 340; 59; 210; 90; 20; 290 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-1149_8469d6fb-d6ef-476f-8cc3-0905192de0a8 0338-1149 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Ma INJECTION INTRAVENOUS 20110205 NDA NDA020678 Baxter Healthcare Corporation ALANINE; ARGININE; CALCIUM CHLORIDE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM PHOSPHATE, DIBASIC; PROLINE; SERINE; SODIUM ACETATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 1035; 575; 33; 25; 515; 240; 300; 365; 290; 51; 200; 280; 261; 340; 250; 340; 59; 210; 90; 20; 290 mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-1301_1508fea2-413e-4728-99de-f412959b83b9 0338-1301 HUMAN PRESCRIPTION DRUG Cefepime cefepime INJECTION, SOLUTION INTRAVENOUS 20080805 NDA NDA050817 Baxter Healthcare Corporation CEFEPIME HYDROCHLORIDE 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0338-1305_f83fb36f-d7ce-4d0f-9f14-966b9e098b23 0338-1305 HUMAN PRESCRIPTION DRUG MESNEX mesna INJECTION, SOLUTION INTRAVENOUS 19881230 NDA NDA019884 Baxter Healthcare Corporation MESNA 100 mg/mL Cytoprotective Agent [EPC] 0338-1452_b054fb2f-e992-4bfd-9774-58baa0746ae2 0338-1452 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018016 Baxter Healthcare Corporation SODIUM CHLORIDE 5 g/1000mL 0338-3503_6f498f63-2225-422f-8fdb-c27759a63c20 0338-3503 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin Sodium INJECTION, SOLUTION INTRAVENOUS 19910328 ANDA ANDA063002 Baxter Healthcare Corporation CEFAZOLIN SODIUM 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0338-3551_b6e3ca42-e5dd-43ae-94d4-1f8b1db627ff 0338-3551 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19581114 NDA NDA050671 Baxter Healthcare Corporation VANCOMYCIN HYDROCHLORIDE 500 mg/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0338-3552_b6e3ca42-e5dd-43ae-94d4-1f8b1db627ff 0338-3552 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19581114 NDA NDA050671 Baxter Healthcare Corporation VANCOMYCIN HYDROCHLORIDE 1 g/200mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0338-3580_b6e3ca42-e5dd-43ae-94d4-1f8b1db627ff 0338-3580 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19581114 NDA NDA050671 Baxter Healthcare Corporation VANCOMYCIN HYDROCHLORIDE 750 mg/150mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0338-3991_452b7b81-e660-414f-acb4-08ababd290bc 0338-3991 HUMAN PRESCRIPTION DRUG IFEX ifosfamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19881230 NDA NDA019763 Baxter Healthcare Corporation IFOSFAMIDE 1 g/20mL Alkylating Activity [MoA],Alkylating Drug [EPC] 0338-3993_452b7b81-e660-414f-acb4-08ababd290bc 0338-3993 HUMAN PRESCRIPTION DRUG IFEX ifosfamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19881230 NDA NDA019763 Baxter Healthcare Corporation IFOSFAMIDE 3 g/60mL Alkylating Activity [MoA],Alkylating Drug [EPC] 0338-5002_26c335ab-eb61-4ed0-b5d0-80b9d3a6f550 0338-5002 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, SOLUTION INTRAVENOUS 20050823 ANDA ANDA065224 Baxter Healthcare Corporation CEFTRIAXONE SODIUM 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0338-5003_26c335ab-eb61-4ed0-b5d0-80b9d3a6f550 0338-5003 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, SOLUTION INTRAVENOUS 20050823 ANDA ANDA065224 Baxter Healthcare Corporation CEFTRIAXONE SODIUM 2 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0338-5197_4e56c101-82ad-4ade-99db-00e413318eb9 0338-5197 HUMAN PRESCRIPTION DRUG Famotidine Famotidine INJECTION, SOLUTION INTRAVENOUS 20010510 ANDA ANDA075591 Baxter Healthcare Corporation FAMOTIDINE 20 mg/50mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0338-6010_78d8f819-f097-494d-9701-61ad3ae23e56 0338-6010 HUMAN PRESCRIPTION DRUG Milrinone Lactate in Dextrose MILRINONE LACTATE INJECTION, SOLUTION INTRAVENOUS 20020528 ANDA ANDA075834 Baxter Healthcare Corporation MILRINONE LACTATE .2 mg/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0338-6011_78d8f819-f097-494d-9701-61ad3ae23e56 0338-6011 HUMAN PRESCRIPTION DRUG Milrinone Lactate in Dextrose MILRINONE LACTATE INJECTION, SOLUTION INTRAVENOUS 20020528 ANDA ANDA075834 Baxter Healthcare Corporation MILRINONE LACTATE .2 mg/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0338-6045_7d4c4cd1-b25b-4d21-9687-8e879438c09d 0338-6045 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION, SOLUTION INTRAVENOUS 20040729 ANDA ANDA076766 Baxter Healthcare Corporation FLUCONAZOLE 400 mg/200mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0338-6046_7d4c4cd1-b25b-4d21-9687-8e879438c09d 0338-6046 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION, SOLUTION INTRAVENOUS 20040729 ANDA ANDA076766 Baxter Healthcare Corporation FLUCONAZOLE 200 mg/100mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0338-6304_3dad4be6-25cf-4ef7-a3bb-692bbd26ef1d 0338-6304 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19701209 NDA NDA016677 Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL 0338-6307_77767f95-e9fe-4b49-b49d-265e7cded459 0338-6307 HUMAN PRESCRIPTION DRUG Lactated Ringers Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride INJECTION, SOLUTION INTRAVENOUS 19710322 NDA NDA016682 Baxter Healthcare Corporation CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20; 30; 600; 310 mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0338-6308_ce789852-ac86-41f5-86ee-65055754ed92 0338-6308 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride dextrose and sodium chloride INJECTION, SOLUTION INTRAVENOUS 19710322 NDA NDA016683 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; 450 g/100mL; mg/100mL 0338-6346_ddd3a63e-9424-428a-b6e7-93ee9ddd820e 0338-6346 HUMAN PRESCRIPTION DRUG Dextrose Dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 19710304 NDA NDA016673 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 50 g/1000mL 0338-6347_ddd3a63e-9424-428a-b6e7-93ee9ddd820e 0338-6347 HUMAN PRESCRIPTION DRUG Dextrose Dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 19710125 NDA NDA016694 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 100 g/1000mL 0338-9540_ae98eb03-c0e7-49d1-b024-77968e3d9d6e 0338-9540 HUMAN PRESCRIPTION DRUG Clinolipid Olive Oil and Soybean Oil INJECTION, EMULSION INTRAVENOUS 20140331 NDA NDA204508 Baxter Healthcare Corporation OLIVE OIL; SOYBEAN OIL 16; 4 g/100mL; g/100mL 0338-9542_ee010eb9-77dd-40cb-b456-062a4c4235eb 0338-9542 HUMAN PRESCRIPTION DRUG Sodium Chloride sodium chloride INJECTION, SOLUTION INTRAVENOUS 20140421 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE 9 g/1000mL 0362-0101_58b2920f-6b2a-4b6d-8712-452649e35af0 0362-0101 HUMAN PRESCRIPTION DRUG Oraverse Phentolamine Mesylate INJECTION, SOLUTION SUBMUCOSAL 20110601 NDA NDA022159 Septodont, Inc. PHENTOLAMINE MESYLATE .235 mg/mL Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0362-6000_f019f064-2265-4ba6-be5d-7771f1e524d5 0362-6000 HUMAN OTC DRUG SeptoSan Hand Sanitizer Alcohol LIQUID TOPICAL 20100930 OTC MONOGRAPH NOT FINAL part333E Septodont, Inc. ALCOHOL 60 L/100L 0362-6001_f019f064-2265-4ba6-be5d-7771f1e524d5 0362-6001 HUMAN OTC DRUG SeptoSan Hand Sanitizer Alcohol LIQUID TOPICAL 20100930 OTC MONOGRAPH NOT FINAL part333E Septodont, Inc. ALCOHOL 60 L/100L 0362-6002_f019f064-2265-4ba6-be5d-7771f1e524d5 0362-6002 HUMAN OTC DRUG SeptoSan Hand Sanitizer Alcohol LIQUID TOPICAL 20100930 OTC MONOGRAPH NOT FINAL part333E Septodont, Inc. ALCOHOL 60 L/100L 0362-9010_63b67155-b87d-4f75-b661-8a91b8284c26 0362-9010 HUMAN PRESCRIPTION DRUG Octocaine 50 Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088389 Septodont EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .02; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0362-9011_1c6ac9a6-f8a6-4ba7-a971-1612ff036213 0362-9011 HUMAN PRESCRIPTION DRUG Vivacaine bupivacaine hydrochloride and epinephrine bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20130601 ANDA ANDA077250 Septodont, Inc. BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE 5; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0362-9011_a0e8fd5f-b1f8-4356-a9fc-d24348155081 0362-9011 HUMAN PRESCRIPTION DRUG Vivacaine bupivacaine hydrochloride and epinephrine bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20091217 ANDA ANDA077250 Septodont Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 5; .0091 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0362-9013_e470f75b-5f30-47a1-886c-be1768920f8f 0362-9013 HUMAN PRESCRIPTION DRUG Prilocaine Hydrochloride with Epinephrine prilocaine and epinephrine INJECTION, SOLUTION SUBCUTANEOUS 20110910 ANDA ANDA078959 Septodont Inc. EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE .005; 40 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0362-9014_30b93d20-538b-4c99-8412-24a76b7a6e20 0362-9014 HUMAN PRESCRIPTION DRUG Prilocaine Hydrochloride prilocaine hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA079235 Septodont Inc. PRILOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0362-9023_76664732-6976-4194-8387-02381283e329 0362-9023 HUMAN PRESCRIPTION DRUG Octocaine 100 Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088390 Septodont EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0362-9048_7b2a8174-0405-4caa-962c-0065ca9eacfa 0362-9048 HUMAN PRESCRIPTION DRUG Septocaine and Epinephrine Articaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20110112 NDA NDA020971 Septodont Inc. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0362-9049_7b2a8174-0405-4caa-962c-0065ca9eacfa 0362-9049 HUMAN PRESCRIPTION DRUG Septocaine and Epinephrine Articaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20110112 NDA NDA020971 Septodont Inc. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0363-0002_8fd961d5-de5f-4e3c-b6bc-1944d055db85 0363-0002 HUMAN OTC DRUG enema Saline ENEMA RECTAL 20091125 OTC MONOGRAPH NOT FINAL part334 Walgreen Company SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 0363-0003_5ced2456-e28d-4dc7-8255-a27b22b486b7 0363-0003 HUMAN OTC DRUG IBUPROFEN ibuprofen CAPSULE, LIQUID FILLED ORAL 20110509 ANDA ANDA079205 Walgreen Company IBUPROFEN 200 mg/1 0363-0004_cfb285a9-4953-4238-9703-acbd4ad185aa 0363-0004 HUMAN OTC DRUG Childrens WAL-DRYL Single-Use Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20110825 OTC MONOGRAPH FINAL part341 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 0363-0005_b3f3fe67-6bcb-4a78-8aa0-82427b01b3ec 0363-0005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 Walgreen Company SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 0363-0006_be00f1a8-3269-4b39-a33a-b0a3d13a1d4f 0363-0006 HUMAN OTC DRUG Mineral Oil Lubricant Laxative mineral oil ENEMA RECTAL 20120716 OTC MONOGRAPH NOT FINAL part334 Walgreen Company MINERAL OIL 118 mL/118mL 0363-0008_7a85e458-8dc6-46b5-a120-5aff9fc00253 0363-0008 HUMAN OTC DRUG pain reliever infants Acetaminophen SUSPENSION/ DROPS ORAL 19950827 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 80 mg/.8mL 0363-0010_b665e581-6f6c-e0e9-c880-68367e49c1c1 0363-0010 HUMAN OTC DRUG Wal-Zan Ranitidine Hydrochloride Tablets 150mg TABLET, COATED ORAL 20110611 ANDA ANDA078192 Walgreens Company RANITIDINE HYDROCHLORIDE 150 mg/1 0363-0011_fe8aa876-a6aa-4457-82d7-5091b776ebe1 0363-0011 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090702 OTC MONOGRAPH FINAL part335 Walgreens BISMUTH SUBSALICYLATE 262 mg/15mL 0363-0013_a6a65a06-5e87-48ed-abc3-fc695c7f76db 0363-0013 HUMAN OTC DRUG wal itin d Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120118 ANDA ANDA076050 Walgreen Company LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 0363-0015_ec8402e9-3bc2-451e-ac3a-6b942c59f56d 0363-0015 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20130701 OTC MONOGRAPH NOT FINAL part334 Walgreen Co MAGNESIUM CITRATE 1.745 g/29.6mL 0363-0018_fcb68dc2-c8b3-44ed-a00f-3dbf0da60bc8 0363-0018 HUMAN OTC DRUG Antibiotic Maximum Strength bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 19980616 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 500; 3.5; 10000 [iU]/g; mg/g; [iU]/g 0363-0019_7370a23a-2d20-4dfb-8cd8-80e22013bf23 0363-0019 HUMAN OTC DRUG Cough Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20140210 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 0363-0022_634a0966-b233-4204-ad3d-b6257403899f 0363-0022 HUMAN OTC DRUG cimetidine acid reducer Cimetidine TABLET ORAL 20010327 ANDA ANDA075285 Walgreen Company CIMETIDINE 200 mg/1 0363-0031_2b65ca6d-64b5-45e2-82bf-0da342d78e18 0363-0031 HUMAN OTC DRUG Cough Relief Daytime Nighttime dextromethorphan HBr, doxylamine succinate KIT 20120906 OTC MONOGRAPH FINAL part341 Walgreen Company 0363-0036_4dbb309a-9de7-4086-ab5d-e237ed999960 0363-0036 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20131107 ANDA ANDA090283 Walgreen Company FAMOTIDINE 20 mg/1 0363-0039_fcb38400-787d-47f3-8aa6-95ae6bd64459 0363-0039 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20140731 OTC MONOGRAPH FINAL part347 Walgreens WITCH HAZEL 842 mg/mL 0363-0041_e77ae2d7-7331-4492-9e78-8eb4b2a9bc4e 0363-0041 HUMAN OTC DRUG Walgreen Nighttime Cold and Flu Relief acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid LIQUID ORAL 20090709 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 0363-0045_38078320-3484-4ea0-bede-e0367fde44d1 0363-0045 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20000929 OTC MONOGRAPH NOT FINAL part356 Walgreens Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 0363-0047_5f4064e6-ce03-4028-855a-e064a9ac5f1b 0363-0047 HUMAN OTC DRUG wal zan acid reducer maximum strength Ranitidine TABLET ORAL 20080204 ANDA ANDA078653 Walgreen Company RANITIDINE HYDROCHLORIDE 150 mg/1 0363-0050_aa64cd26-c476-4649-a750-f06b13312bcf 0363-0050 HUMAN OTC DRUG Ibuprofen PM diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090219 ANDA ANDA079113 Walgreen Company DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 0363-0052_95760f77-90d8-43c7-a6ee-c178bbb99fef 0363-0052 HUMAN OTC DRUG Childrens Wal-Fex Fexofenadine Hydrochloride SUSPENSION ORAL 20141219 ANDA ANDA203330 Walgreen Company FEXOFENADINE HYDROCHLORIDE 30 mg/5mL 0363-0054_83022bc1-c372-4c74-93c2-0ed66c57aad3 0363-0054 HUMAN OTC DRUG Wal Phed Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19990924 ANDA ANDA075153 Walgreen Company PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 0363-0055_7aa3cbf9-c368-49da-ae1a-c0a4349b8973 0363-0055 HUMAN OTC DRUG Vaporizing Camphor INHALANT RESPIRATORY (INHALATION) 20090601 OTC MONOGRAPH FINAL part341 Walgreen Co CAMPHOR (SYNTHETIC) 62 mg/mL 0363-0057_b9c7d20e-e3ed-455d-b1a8-d2b57c77202f 0363-0057 HUMAN OTC DRUG Ibuprofen Infants ibuprofen SUSPENSION ORAL 20010413 ANDA ANDA075217 Walgreen Company IBUPROFEN 50 mg/1.25mL 0363-0060_cfb67ead-61f9-4d0f-b2db-792b8df3d148 0363-0060 HUMAN OTC DRUG Wal-Sleep Z Diphenhydramine HCl / Sleep Aid Diphenhydramine Hydrochloride CAPSULE, GELATIN COATED ORAL 20111208 OTC MONOGRAPH FINAL part338 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/21 0363-0061_4bb5f838-f628-406a-a6f8-c18cb9637fc2 0363-0061 HUMAN OTC DRUG walphed d maximum strength non drowsy sinus Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 19990924 ANDA ANDA075153 Walgreen Company PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 0363-0063_3f67b412-7cb5-47b3-b96e-05e89108f517 0363-0063 HUMAN OTC DRUG Hydrocortisone Plus Hydrocortisone CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part348 Walgreens HYDROCORTISONE 10 mg/g 0363-0065_ea5aa7ce-a366-45d7-8d9f-37ebf13b4c4e 0363-0065 HUMAN OTC DRUG anefrin nasal extra moisturizing Oxymetazoline HCl SPRAY NASAL 19940701 OTC MONOGRAPH FINAL part341 Walgreen Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 0363-0067_2ea38a1d-ff9a-49ed-9fbf-dd10642f22bf 0363-0067 HUMAN OTC DRUG Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20080311 OTC MONOGRAPH FINAL part347 Walgreen Co LANOLIN; PETROLATUM 133; 459 mg/g; mg/g 0363-0069_8317e191-da56-4f0f-9d30-c56adecda668 0363-0069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 19950330 OTC MONOGRAPH FINAL part347 Walgreen Co PETROLATUM 1 g/g 0363-0070_e1bc150d-98a6-4e90-ad8d-21a9416a8f5e 0363-0070 HUMAN OTC DRUG Anticavity Sodium Fluoride RINSE ORAL 20130923 OTC MONOGRAPH FINAL part355 Walgreen Co. SODIUM FLUORIDE .05 mg/mL 0363-0072_831aeba0-159a-4fba-98e9-f772017c7c2d 0363-0072 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20070330 OTC MONOGRAPH NOT FINAL part348 Walgreens Co. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 0363-0080_b9742419-3b20-4558-9e81-1287020a1eee 0363-0080 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130910 OTC MONOGRAPH NOT FINAL part356 Walgreen Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 0363-0081_3fb97e73-a088-472b-928e-1807fa822e1b 0363-0081 HUMAN OTC DRUG Miconazole 3 Miconazole nitrate KIT 20050701 ANDA ANDA075329 Walgreen Company 0363-0083_faa26964-a140-4d30-ab1e-19f49f9458ac 0363-0083 HUMAN OTC DRUG wal profen cold and sinus Ibuprofen, Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011008 ANDA ANDA074567 Walgreen Company IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 0363-0089_d3a96d78-13d6-49f7-80c0-8a148e8165fc 0363-0089 HUMAN OTC DRUG Pain and Fever Childrens Acetaminophen LIQUID ORAL 20140530 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN 160 mg/5mL 0363-0091_b859f59c-6a70-4d7a-8a68-432ae1bf7cf1 0363-0091 HUMAN OTC DRUG Pain and Fever Infants Acetaminophen SUSPENSION ORAL 20140831 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN 160 mg/5mL 0363-0096_7b69bbe3-4686-454a-8186-c808515943e1 0363-0096 HUMAN OTC DRUG wal flu severe cold and cough daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20120117 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 0363-0098_24382ade-c86d-4063-97b7-7aa93295fdff 0363-0098 HUMAN OTC DRUG naproxen sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20140804 NDA NDA021920 Walgreen Company NAPROXEN SODIUM 220 mg/1 0363-0099_4d4e84b1-4a8a-402f-ab23-d76d475b63d4 0363-0099 HUMAN OTC DRUG Health Cetylpyridinium chloride MOUTHWASH ORAL 20070419 OTC MONOGRAPH NOT FINAL part356 Walgreen Co CETYLPYRIDINIUM CHLORIDE .7 mg/mL 0363-0104_4f56eedd-3760-4d93-8977-b05daed74af8 0363-0104 HUMAN OTC DRUG Regular Strength Pain Reliever Acetaminophen TABLET ORAL 19900713 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN 325 mg/1 0363-0105_0707e034-3af4-4102-930f-4f47d5e7a147 0363-0105 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 19960125 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL 0363-0108_ac260157-d949-45d0-8aea-a9a6f6de8031 0363-0108 HUMAN OTC DRUG Milk of Magnesia Original MAGNESIUM HYDROXIDE SUSPENSION ORAL 20100204 OTC MONOGRAPH FINAL part334 Walgreens MAGNESIUM HYDROXIDE 1200 mg/15mL 0363-0108_c0e014dd-0865-4415-9a71-c836f359b9b6 0363-0108 HUMAN OTC DRUG Milk of Magnesia Original MAGNESIUM HYDROXIDE SUSPENSION ORAL 20100204 OTC MONOGRAPH FINAL part334 Walgreens MAGNESIUM HYDROXIDE 1200 mg/15mL 0363-0110_456be4e6-6e3f-4344-a31e-1d880cc5bfd9 0363-0110 HUMAN OTC DRUG Feminine Povidone-iodine KIT 20091125 OTC MONOGRAPH NOT FINAL part333A Walgreen Company 0363-0111_a7464be3-352d-485c-8535-2ce82c35e66f 0363-0111 HUMAN OTC DRUG Wal-phed Chlorpheniramine Maleate and Pseudoephedrine HCl TABLET ORAL 19921216 OTC MONOGRAPH FINAL part341 WALGREEN CO. CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 60 mg/1; mg/1 0363-0112_b5b22458-bfb1-4da1-8691-3a56678a9fd7 0363-0112 HUMAN OTC DRUG Wal-phed Pseudophedrine HCl TABLET ORAL 19810825 OTC MONOGRAPH FINAL part341 WALGREEN CO. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 0363-0113_e280f55b-6fe2-452b-b8a6-e5b98259996f 0363-0113 HUMAN OTC DRUG Walgreens Urinary Pain Relief Maximum Strength PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20100405 UNAPPROVED DRUG OTHER Walgreens Co. PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 0363-0117_edd423a3-0ee7-4622-9f95-82d94c3ae354 0363-0117 HUMAN OTC DRUG well at walgreens lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 Walgreen Company LANSOPRAZOLE 15 mg/1 0363-0122_122909d9-119e-43fe-ad8a-8c8e665eb17a 0363-0122 HUMAN OTC DRUG Wal-dryl diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20140327 OTC MONOGRAPH NOT FINAL part348 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 mg/g; mg/g 0363-0123_1bd8afaf-0012-4a7e-a143-3f056c4ee1ea 0363-0123 HUMAN OTC DRUG Triple Antibiotic with Pain Relief Maximum Strength bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride OINTMENT TOPICAL 20140327 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 0363-0124_5919f99c-4721-4826-a1cf-07971efe60d2 0363-0124 HUMAN OTC DRUG nicotine Nicotine polacrilex LOZENGE ORAL 20090915 ANDA ANDA090711 Walgreen Company NICOTINE 2 mg/1 0363-0125_65153d48-2e09-4f53-b993-cec2c8353396 0363-0125 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20120530 OTC MONOGRAPH FINAL part347 Walgreens DIMETHICONE 180 mg/1 0363-0126_086fba92-75d0-4c2b-abcd-72ba10b86574 0363-0126 HUMAN OTC DRUG Oral Saline Laxative dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20121005 OTC MONOGRAPH NOT FINAL part334 Walgreen Co SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC .9; 2.4 g/15mL; g/15mL 0363-0129_f6067c74-0686-46bc-9b93-3984d766e882 0363-0129 HUMAN OTC DRUG Wal-Zyr 24 Hour Allergy Cetirizine HCl TABLET ORAL 20131230 ANDA ANDA078780 Walgreens CETIRIZINE HYDROCHLORIDE 10 mg/1 0363-0130_2b839aff-d60e-43ab-b58c-bd8184a460d6 0363-0130 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 19951013 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL 0363-0131_3962d817-fc15-4a67-c924-af58500d6325 0363-0131 HUMAN OTC DRUG Wal-Zan 75 Ranitidine Tablet USP, 75mg TABLET ORAL 20140106 ANDA ANDA075294 Walgreens Company RANITIDINE HYDROCHLORIDE 75 mg/1 0363-0132_8ec2e78c-c34e-410d-9f42-b823b66fc2d8 0363-0132 HUMAN OTC DRUG Pain and Fever Infants Acetaminophen LIQUID ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN 160 mg/5mL 0363-0133_bf4e9df8-b166-4700-b722-42077eb98f93 0363-0133 HUMAN OTC DRUG wal flu flu and sore throat acetaminophen,pheniramine maleate, phenylephrine hydrochloride POWDER, FOR SUSPENSION ORAL 20101113 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/15000mg; mg/15000mg; mg/15000mg 0363-0140_e28062c5-5889-44a7-8c81-0655fded6392 0363-0140 HUMAN OTC DRUG pain relief Naproxen sodium TABLET, FILM COATED ORAL 20111022 ANDA ANDA074661 Walgreen Company NAPROXEN SODIUM 220 mg/1 0363-0141_98c6ddc9-8103-40b3-a145-ffbe3374ab6c 0363-0141 HUMAN OTC DRUG Acid Controller Original Strength Famotidine TABLET ORAL 20090828 ANDA ANDA075400 Walgreen Company FAMOTIDINE 10 mg/1 0363-0147_98a3602e-5bd2-4cc6-be00-4b6b299b37d3 0363-0147 HUMAN OTC DRUG WALGREENS COOL AND HEAT MUSCLE AND JOINT RELIEF MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20130331 OTC MONOGRAPH NOT FINAL part348 WALGREEN COMPANY MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g 0363-0148_dd1b593c-9461-4032-8eb2-1e107457879e 0363-0148 HUMAN OTC DRUG Extra Strength Wal-Nadol Acetaminophen TABLET ORAL 19930121 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN 500 mg/1 0363-0149_6f0db00f-2cba-4146-88d6-ff9d3b7ce982 0363-0149 HUMAN OTC DRUG WALGREENS MEDICATED PAIN RELIEVING CAMPHOR, MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20130228 OTC MONOGRAPH NOT FINAL part348 WALGREENS CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 7.1; 33; 36 mg/1; mg/1; mg/1 0363-0150_b413af71-fd41-4fe6-a91b-8fb14a3fda74 0363-0150 HUMAN OTC DRUG Cool n Heat Patch for Arm, Neck and Leg Extra Strength Menthol PATCH TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part348 Walgreen Co. MENTHOL .05 mg/g 0363-0151_8f42099d-c592-4952-9905-87766928b689 0363-0151 HUMAN OTC DRUG Pain Relieving Patch Ultra Strength Menthol PATCH TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part348 Walgreen Co. MENTHOL .05 mg/g 0363-0152_a9a1b401-911e-4504-a898-657326fa2c20 0363-0152 HUMAN OTC DRUG Cool n Heat Patch for Back Extra Strength Menthol PATCH TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part348 Walgreen Co. MENTHOL .05 mg/g 0363-0157_4d338be5-0a49-424f-a51e-e1f6e9333a31 0363-0157 HUMAN OTC DRUG Regular Strength Aspirin Aspirin TABLET ORAL 19960210 OTC MONOGRAPH FINAL part343 WALGREEN CO. ASPIRIN 325 mg/1 0363-0159_7912f5f0-b5f3-49d5-8087-179bf6edb85f 0363-0159 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0363-0160_bcf0d84a-b66b-48b9-81e1-f94a115c6f40 0363-0160 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20120929 OTC MONOGRAPH FINAL part346 Walgreen Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g 0363-0161_bc3eb242-eef1-4061-8555-802618f71308 0363-0161 HUMAN OTC DRUG pain and fever Acetaminophen SUSPENSION ORAL 20110916 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL 0363-0163_b888f71b-7ce9-4992-8a74-c575f6126bf4 0363-0163 HUMAN OTC DRUG Mouth Rinse sodium fluoride MOUTHWASH ORAL 20060315 OTC MONOGRAPH FINAL part355 Walgreen SODIUM FLUORIDE .1 mg/mL 0363-0164_ca91d886-f904-4327-8fcb-168ba4724b18 0363-0164 HUMAN OTC DRUG Regular Strength Aspirin Aspirin and Caffeine TABLET, FILM COATED ORAL 20110101 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ASPIRIN; CAFFEINE 400; 32 mg/1; mg/1 0363-0165_a20917e7-5b07-4cbb-a3d0-fef669096c7b 0363-0165 HUMAN OTC DRUG Wal itin D non drowsy Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20030604 ANDA ANDA075706 Walgreen Company LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 0363-0166_e8239f19-1a4a-4bff-bcc7-f9f4b2163710 0363-0166 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 20020304 ANDA ANDA074937 Walgreen Company IBUPROFEN 100 mg/5mL 0363-0168_64a44c77-f25a-4ab5-9b99-64acbb36e45e 0363-0168 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140331 ANDA ANDA079096 Walgreens NAPROXEN SODIUM 220 mg/1 0363-0169_bc95dbc6-6a33-49b1-a2df-06bdd25dc2fc 0363-0169 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140331 ANDA ANDA079096 Walgreens NAPROXEN SODIUM 220 mg/1 0363-0170_b93096ad-1c4d-4209-aa72-7a12995cd1ae 0363-0170 HUMAN OTC DRUG Stool Softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20120701 OTC MONOGRAPH NOT FINAL part334 Walgreens DOCUSATE CALCIUM 240 mg/1 0363-0173_07fe7321-17f8-48db-86c8-d85bc62aa1da 0363-0173 HUMAN OTC DRUG Stop Lice Complete Lice Treatment Piperonyl Butoxide, Pyrethrum Extract KIT 20071029 OTC MONOGRAPH FINAL part358G Walgreen Company 0363-0173_aa78b19c-db29-49f8-8b88-2143845f8fc5 0363-0173 HUMAN OTC DRUG complete lice treatment kit Piperonyl Butoxide, Pyrethrum Extract KIT 20071029 OTC MONOGRAPH FINAL part358G Walgreen Company 0363-0174_b84a34b0-28c8-4d63-a84a-f9d0cc0a2530 0363-0174 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141031 NDA NDA021920 Walgreens NAPROXEN SODIUM 220 mg/1 0363-0175_018350f5-aa77-4d14-9574-f2d2c11a4335 0363-0175 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN 500 mg/1 0363-0176_d1963568-14c0-4c55-bf08-b479e7d13ac3 0363-0176 HUMAN OTC DRUG Wal Zyr D Allergy and Congestion Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080410 ANDA ANDA077170 Walgreen Company CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 0363-0178_dfc4115b-3158-48f9-8245-514964afab0e 0363-0178 HUMAN OTC DRUG Wal-Act Pseudoephedrine HCl and Tripolidine TABLET, FILM COATED ORAL 19930109 OTC MONOGRAPH FINAL part341 WALGREEN CO. PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 60; 2.5 mg/1; mg/1 0363-0179_33b545cc-00a3-4c9b-9405-f0e922d4590a 0363-0179 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin-b sulfate OINTMENT TOPICAL 20050119 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 0363-0180_34edbae8-e952-4908-a425-b9f029bb4502 0363-0180 HUMAN OTC DRUG Senna SENNOSIDES TABLET ORAL 20120817 OTC MONOGRAPH NOT FINAL part334 Walgreens SENNOSIDES 8.6 mg/1 0363-0181_87eb37fb-48c4-40b4-a280-b8d15630609b 0363-0181 HUMAN OTC DRUG smooth lax original prescription strength Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091008 ANDA ANDA090685 Walgreen Company POLYETHYLENE GLYCOL 3350 17 g/17g 0363-0183_73f8df05-b02d-47d4-9bbb-e3d15d51b353 0363-0183 HUMAN OTC DRUG Regular Strength Tri-Buffered Aspirin Aspirin TABLET, FILM COATED ORAL 19900330 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ASPIRIN 325 mg/1 0363-0188_b87b5ed4-98e0-4b84-b739-6f808b495c89 0363-0188 HUMAN OTC DRUG Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140130 OTC MONOGRAPH FINAL part346 Walgreen Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 0363-0189_1ebdf161-e908-4cc6-b6ca-f96202097581 0363-0189 HUMAN OTC DRUG Sleep II Diphenhydramine HCl TABLET ORAL 19921225 OTC MONOGRAPH FINAL part341 WALGREEN CO. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0363-0190_688f2a5e-4b32-4990-b1c2-ce7cb58c5d5f 0363-0190 HUMAN OTC DRUG Wal-Dryl Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part336 WALGREEN CO. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0363-0195_8c76b580-9e1c-4ea4-8198-c5b5677318a6 0363-0195 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20100215 NDA NDA020165 Walgreen Company NICOTINE 14 mg/24h 0363-0196_8c76b580-9e1c-4ea4-8198-c5b5677318a6 0363-0196 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20100215 NDA NDA020165 Walgreen Company NICOTINE 7 mg/24h 0363-0197_69d7d4ff-1dac-47c0-8f14-a57aff5c7a63 0363-0197 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130930 ANDA ANDA078682 Walgreens IBUPROFEN 200 mg/1 0363-0198_6bfcd1dd-be5e-4a72-b401-26dd04036ff0 0363-0198 HUMAN OTC DRUG Wal-Dram Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 WALGREEN CO. DIMENHYDRINATE 50 mg/1 0363-0199_0c5ad8b0-d485-40aa-b4fa-f61d490bcf94 0363-0199 HUMAN OTC DRUG Miconazole 1 Miconazole nitrate KIT 20100610 ANDA ANDA079114 Walgreen Company 0363-0201_07416223-0d61-4ccf-8a9e-e7841bd45051 0363-0201 HUMAN OTC DRUG nicotine Nicotine polacrilex LOZENGE ORAL 20100112 ANDA ANDA090821 Walgreen Company NICOTINE 2 mg/1 0363-0202_9391b4af-a108-4783-9bc0-efcf9761bd50 0363-0202 HUMAN OTC DRUG Minoxidil For Women minoxidil SOLUTION TOPICAL 20110228 ANDA ANDA075357 Walgreen Company MINOXIDIL 2 g/100mL 0363-0205_5a1eb26e-b569-49a4-b8b6-eef87a53a9b0 0363-0205 HUMAN OTC DRUG athletes foot Tolnaftate SPRAY TOPICAL 20040910 OTC MONOGRAPH FINAL part333C Walgreen Company TOLNAFTATE 1 g/100g 0363-0208_ad1bccff-35aa-4c09-b497-fb4f8e9c7def 0363-0208 HUMAN OTC DRUG NICOTINE Original nicotine polacrilex LOZENGE ORAL 20021031 NDA NDA021330 Walgreens NICOTINE 2 mg/1 0363-0209_ad1bccff-35aa-4c09-b497-fb4f8e9c7def 0363-0209 HUMAN OTC DRUG NICOTINE Original nicotine polacrilex LOZENGE ORAL 20021031 NDA NDA021330 Walgreens NICOTINE 4 mg/1 0363-0211_2f4a8f61-60bf-47b3-8dbf-ae6993f494cb 0363-0211 HUMAN OTC DRUG 24 Hour Allergy Cetirizine HCl CAPSULE ORAL 20130301 NDA NDA022429 Walgreens CETIRIZINE HYDROCHLORIDE 10 mg/1 0363-0212_2638fa77-26ea-4812-8418-2ed6be4d2f63 0363-0212 HUMAN OTC DRUG childrens pain and fever Acetaminophen SUSPENSION ORAL 19951013 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL 0363-0213_d103ad81-efd3-4f59-b437-dbe04bf2869c 0363-0213 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130531 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 0363-0214_5d64cc50-c2bf-4449-9989-56f46db7da57 0363-0214 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090929 OTC MONOGRAPH NOT FINAL part356 Walgreens HYDROGEN PEROXIDE 2.65 mL/100mL 0363-0217_bba0b6cd-4573-4625-94d3-c02dadc9cf44 0363-0217 HUMAN OTC DRUG pain reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 19910415 ANDA ANDA075077 Walgreen Company ACETAMINOPHEN 650 mg/1 0363-0218_04e55ab9-f5dd-4081-9030-4ae9054fdd80 0363-0218 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ASPIRIN 81 mg/1 0363-0220_9cf11c80-3aa0-4f2b-83e4-f2ce8425a14d 0363-0220 HUMAN OTC DRUG Clotrimazole clotrimazole CREAM VAGINAL 19980901 ANDA ANDA074165 Walgreen Company CLOTRIMAZOLE 1 g/100g 0363-0223_14c0e8e3-f36f-4b10-8f76-2079600ca6f4 0363-0223 HUMAN OTC DRUG Wal-Som Diphenhydramine hydrochloride TABLET ORAL 20120822 OTC MONOGRAPH FINAL part338 Walgreen DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0363-0224_d67fbd06-c7bc-4679-8362-3b6137c683fc 0363-0224 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19960105 OTC MONOGRAPH FINAL part347 Walgreen Co. FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL 0363-0226_3e722a6e-99ee-4931-94ed-79ea1a0929b5 0363-0226 HUMAN OTC DRUG Stay Awake Maximum Strength Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 WALGREEN CO. CAFFEINE 200 mg/1 0363-0227_cb74f97d-6a34-481b-9f3f-962266fb25fb 0363-0227 HUMAN OTC DRUG Safety Coated Enteric Aspirin Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH FINAL part343 WALGREEN CO. ASPIRIN 325 mg/1 0363-0235_4852eb08-e3ad-4edf-abc9-d683c6521e23 0363-0235 HUMAN OTC DRUG Wal-Nadol PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 0363-0236_614b7a49-7ed3-42a1-b57e-d59d8751fce7 0363-0236 HUMAN OTC DRUG Nighttime Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Walgreens DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 0363-0238_d4d47137-4c86-4af4-9d01-420e066f305d 0363-0238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH NOT FINAL part334 Walgreens DOCUSATE SODIUM 100 mg/1 0363-0243_c03af79f-4561-46e3-bc74-97da3debb096 0363-0243 HUMAN OTC DRUG Antibacterial Hand Triclosan LIQUID TOPICAL 20120404 OTC MONOGRAPH FINAL part333A Walgreen Co TRICLOSAN .15 kg/100L 0363-0244_0e2cba4b-22b6-4d46-b809-6ccfe0f4ba54 0363-0244 HUMAN OTC DRUG Non-Drowsy Formula Wal-Tussin Dextromethorphan HBr CAPSULE, GELATIN COATED ORAL 20060424 OTC MONOGRAPH FINAL part341 WALGREEN CO. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 0363-0246_952c3f32-05ce-4fd9-80f8-ee16ab16473b 0363-0246 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20131030 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 0363-0247_9eebf373-c452-4d18-be0d-488d7f18eca3 0363-0247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140930 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0363-0248_e775c809-5e0a-4cdd-93cd-00a2fa118cba 0363-0248 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20090123 OTC MONOGRAPH FINAL part341 Walgreen CO CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100kg; kg/100kg 0363-0252_f3047812-0c0c-4acd-afb9-63b7e01e7839 0363-0252 HUMAN OTC DRUG Maximum Strength Menstrual Relief Acetaminophen, Caffeine and Pyrilamine maleate CAPSULE ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 0363-0255_e8541364-d649-42e9-9e41-e3201ba10433 0363-0255 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20050513 ANDA ANDA075217 Walgreen Company IBUPROFEN 50 mg/1.25mL 0363-0257_2ae291b4-4ce8-4c6b-a666-889c7f3ecabd 0363-0257 HUMAN OTC DRUG Stool Softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20140731 OTC MONOGRAPH NOT FINAL part334 Walgreens DOCUSATE CALCIUM 240 mg/1 0363-0260_e09f76ca-f401-42a3-a1a6-cfc8eec8eb78 0363-0260 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20090402 OTC MONOGRAPH NOT FINAL part334 Walgreens MINERAL OIL 15 mL/15mL 0363-0271_600fdda8-4384-4082-8e4d-506cb2cded42 0363-0271 HUMAN OTC DRUG Wal Zan 75 Ranitidine TABLET ORAL 20090224 ANDA ANDA076760 Walgreen Company RANITIDINE HYDROCHLORIDE 75 mg/1 0363-0272_d2b6a1d1-91be-4959-b907-c47c574696cc 0363-0272 HUMAN OTC DRUG Wal itin D Pseudoephedrine sulfate, Loratadine TABLET, FILM COATED ORAL 20090324 ANDA ANDA075989 Walgreen Company LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 0363-0279_e511d184-aedd-46f7-ab90-d7724766df73 0363-0279 HUMAN OTC DRUG Hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140926 OTC MONOGRAPH FINAL part346 Walgreen Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 0363-0281_93702004-cfaa-4918-8487-130528378429 0363-0281 HUMAN OTC DRUG Pain and Fever Childrens Acetaminophen LIQUID ORAL 20140530 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN 160 mg/5mL 0363-0282_5243fbe1-e45d-4673-86bf-6f8454d36f39 0363-0282 HUMAN OTC DRUG Wal Hist Clemastine fumarate TABLET ORAL 19960531 ANDA ANDA074512 Walgreen Company CLEMASTINE FUMARATE 1.34 mg/1 0363-0288_9792da6c-1b7b-45d6-8e12-83391768524a 0363-0288 HUMAN OTC DRUG childrens chest congestion Guaifenesin LIQUID ORAL 20070830 OTC MONOGRAPH FINAL part341 Walgreen Company GUAIFENESIN 100 mg/5mL 0363-0289_c89d8329-ff48-4004-a6cc-e02640d27ddb 0363-0289 HUMAN OTC DRUG Pain Reliever Infants Acetaminophen SUSPENSION/ DROPS ORAL 19930803 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 80 mg/.8mL 0363-0291_fb709aad-fbb8-4030-aaf3-96917c553552 0363-0291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 WALGREEN CO. IBUPROFEN 200 mg/1 0363-0292_9c016554-c80c-4830-93b3-e725371ce2ee 0363-0292 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 WALGREEN CO. IBUPROFEN 200 mg/1 0363-0294_ea4bfda0-12ee-4103-a71e-96098f3bf090 0363-0294 HUMAN OTC DRUG minoxidil Minoxidil AEROSOL, FOAM TOPICAL 20120301 ANDA ANDA091344 Walgreen Company MINOXIDIL 5 g/100g 0363-0295_e230b668-0081-43b2-9405-36893cde2b64 0363-0295 HUMAN OTC DRUG Anti-Itch Wal-Dryl Diphenhydramine HCl, Zinc Acetate SPRAY TOPICAL 20110708 OTC MONOGRAPH NOT FINAL part348 Walgreen's Co DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 kg/100L; kg/100L 0363-0296_2840a640-08a8-4969-9499-414b2c180f53 0363-0296 HUMAN OTC DRUG wal tussin cf max dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20120830 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL 0363-0299_92e767ee-e0ef-4b05-8af7-03dc1bb267fa 0363-0299 HUMAN OTC DRUG wal itin d non drowsy 24 hour allergy and congestion Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20030604 ANDA ANDA075706 Walgreen Company LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 0363-0300_1ca727d4-d6cf-49fb-b2c1-1e4a479f3f56 0363-0300 HUMAN OTC DRUG Adult Wal Tussin Cough Long Acting Dextromethorphan Hydrobromide SOLUTION ORAL 20040903 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL 0363-0301_fe5cd0f5-2a49-4865-a48e-4526536acc26 0363-0301 HUMAN OTC DRUG Magnesium Citrate Magnesium Citrate LIQUID ORAL 20090402 OTC MONOGRAPH NOT FINAL part334 Walgreens MAGNESIUM CITRATE 2.65 mL/100mL 0363-0302_1de59be8-4ca1-422b-a2cb-d07a3e25b138 0363-0302 HUMAN OTC DRUG Magnesium Citrate Magnesium Citrate LIQUID ORAL 20090402 OTC MONOGRAPH NOT FINAL part334 Walgreens MAGNESIUM CITRATE 2.65 mL/100mL 0363-0304_46acf193-4b77-4c95-9226-0f8a00cd30ca 0363-0304 HUMAN OTC DRUG Anefrin Nasal Original oxymetazoline hydrochloride SPRAY NASAL 19950928 OTC MONOGRAPH FINAL part341 Walgreen Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 0363-0306_7ed20688-14b0-40a0-a0be-34cc88c6675b 0363-0306 HUMAN OTC DRUG smooth lax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091009 ANDA ANDA090685 Walgreen Company POLYETHYLENE GLYCOL 3350 17 g/17g 0363-0307_c816e31d-e80e-4e32-9d84-f5d2e389fe80 0363-0307 HUMAN OTC DRUG Lubricant Eye Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20130426 OTC MONOGRAPH FINAL part349 Walgreens POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL 0363-0310_583224db-a9c1-44ea-8625-62d8109ebd66 0363-0310 HUMAN OTC DRUG wal tussin adult chest congestion Guaifenesin SYRUP ORAL 19951013 OTC MONOGRAPH FINAL part341 Walgreen Company GUAIFENESIN 200 mg/10mL 0363-0311_a04d44b6-5b74-4528-80eb-f9155c083e2d 0363-0311 HUMAN OTC DRUG Peptic Relief Cherry Bismuth Subsalicylate SUSPENSION ORAL 20090730 OTC MONOGRAPH FINAL part335 Walgreens BISMUTH SUBSALICYLATE 262 mg/15mL 0363-0318_9fc84183-747f-48ab-a892-7d393e9782cc 0363-0318 HUMAN OTC DRUG Mouth Rinse Eucalyptol, menthol, Methyl salicylate, thymol MOUTHWASH ORAL 19900515 OTC MONOGRAPH NOT FINAL part356 Walgreen Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 g/L; g/L; g/L; g/L 0363-0319_d974a19e-8f68-4bf2-b6b7-72b4498e788c 0363-0319 HUMAN OTC DRUG Soothe BISMUTH SUBSALICYLATE TABLET, CHEWABLE ORAL 19980716 OTC MONOGRAPH FINAL part335 WALGREEN CO. BISMUTH SUBSALICYLATE 262 mg/1 0363-0321_2a09cd23-6145-4212-84af-60e80332388b 0363-0321 HUMAN OTC DRUG Acid Controller Complete dual action famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080730 ANDA ANDA077355 Walgreen Company CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 0363-0326_9e3a9f44-513f-43ea-8036-1ac87d6f16e5 0363-0326 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20050212 OTC MONOGRAPH NOT FINAL part334 WALGREEN CO. BISACODYL 5 mg/1 0363-0327_421c8735-3636-4238-9554-9017477474cf 0363-0327 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 WALGREEN CO. BISACODYL 5 mg/1 0363-0329_361a73a0-0d5a-4388-8797-245dff989f6d 0363-0329 HUMAN OTC DRUG WAL-DRYL ALLERGY Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 WALGREEN CO. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0363-0330_a2fc65f3-2870-4335-9812-6ae609826407 0363-0330 HUMAN OTC DRUG infants dye free pain and fever Acetaminophen LIQUID ORAL 20131022 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL 0363-0332_74348b6c-e6ec-4375-8c8d-ec8d7f2a1cb2 0363-0332 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 19951110 OTC MONOGRAPH NOT FINAL part334 Walgreen Company MAGNESIUM HYDROXIDE 1200 mg/15mL 0363-0333_cd2d5c26-3e21-4d20-884e-a230de008153 0363-0333 HUMAN OTC DRUG enema mineral oil ready to use Mineral Oil LIQUID RECTAL 19910315 OTC MONOGRAPH NOT FINAL part334 Walgreen Company MINERAL OIL 100 mL/100mL 0363-0334_a055ff27-c27d-43af-8034-862be8c55e30 0363-0334 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Walgreen Company ACETAMINOPHEN 650 mg/1 0363-0335_b7ec6e9e-d5bb-4c5d-b749-1ef04215e6ce 0363-0335 HUMAN OTC DRUG nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110808 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 0363-0336_776b9951-3ee3-4b38-a321-77ba0bc154a3 0363-0336 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Walgreen Company ACETAMINOPHEN 650 mg/1 0363-0338_b34056cf-b66e-4f56-bc09-919d870cbe11 0363-0338 HUMAN OTC DRUG Extra Strength Backache Relief Magnesium Salicylate Tetrahydrate CAPSULE ORAL 19981107 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. MAGNESIUM SALICYLATE 580 mg/1 0363-0339_87a1e991-3939-42a8-9a3c-07fade8cdc07 0363-0339 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20100716 OTC MONOGRAPH NOT FINAL part348 Walgreen Company HYDROCORTISONE 1 g/100g 0363-0340_e8691c00-0064-4705-9820-8e58dd0f0947 0363-0340 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, EXTENDED RELEASE ORAL 20121221 ANDA ANDA078569 Walgreen Company ACETAMINOPHEN 650 mg/1 0363-0341_8927040e-9c9e-4edb-a35b-b74591fcbede 0363-0341 HUMAN OTC DRUG Athletes Foot Miconazole Nitrate SPRAY TOPICAL 20050609 OTC MONOGRAPH FINAL part333C Walgreen Company MICONAZOLE NITRATE 2 g/100g 0363-0342_18b42bcc-2fb4-4592-a828-2e3419fac88e 0363-0342 HUMAN OTC DRUG Hydrocortisone Regular Strength Hydrocortisone CREAM TOPICAL 19970107 OTC MONOGRAPH NOT FINAL part348 Walgreen Company HYDROCORTISONE .5 g/100g 0363-0343_18b42bcc-2fb4-4592-a828-2e3419fac88e 0363-0343 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 19900101 OTC MONOGRAPH NOT FINAL part348 Walgreen Company HYDROCORTISONE 1 g/100g 0363-0344_762c9fc0-80d9-4e69-bb1f-cd9e4e74d476 0363-0344 HUMAN OTC DRUG Anticavity Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20100722 OTC MONOGRAPH FINAL part355 Walgreen Co SODIUM FLUORIDE .1 mg/mL 0363-0345_9bc859cb-6a2b-4dd9-9340-b07143c11c81 0363-0345 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone OINTMENT TOPICAL 20100716 OTC MONOGRAPH NOT FINAL part348 Walgreen Company HYDROCORTISONE 1 g/100g 0363-0346_e5597e1b-6b4f-4321-8b5e-4f07a4cae307 0363-0346 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate CAPSULE ORAL 20110506 OTC MONOGRAPH FINAL part335 WALGREEN CO. BISMUTH SUBSALICYLATE 262 mg/1 0363-0347_4ddfc463-175d-4c3b-9fd3-30671f4023c5 0363-0347 HUMAN OTC DRUG Laxative Sennoside TABLET ORAL 20031208 OTC MONOGRAPH NOT FINAL part334 WALGREEN CO. SENNOSIDES A AND B 15 mg/1 0363-0348_2ed880b3-d351-414e-9de9-88ff60a2756f 0363-0348 HUMAN OTC DRUG Maximum Strength Laxative Sennosides TABLET ORAL 20030104 OTC MONOGRAPH NOT FINAL part334 WALGREEN CO. SENNOSIDES A AND B 25 mg/1 0363-0350_cf462529-fe36-43eb-b45b-bfde56711349 0363-0350 HUMAN OTC DRUG PAIN RELIEVER PM Extra Strength Acetaminophen, Diphenhydramine HCl CAPSULE, GELATIN COATED ORAL 20130531 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 0363-0351_9a6a22b3-c724-4f8e-9102-2bc2d1637155 0363-0351 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 19950921 OTC MONOGRAPH NOT FINAL part334 WALGREEN CO. DOCUSATE SODIUM 100 mg/1 0363-0352_94d81b3b-2e78-4691-8bb0-f003fddc5395 0363-0352 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130924 ANDA ANDA201745 Walgreen Company RANITIDINE HYDROCHLORIDE 75 mg/1 0363-0359_3fafeaf8-e818-46b8-85b9-bff6d1b88b38 0363-0359 HUMAN OTC DRUG Wal Tussin Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 19951006 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 0363-0360_ce5ea0c1-6d8b-41a3-aac1-5d2f59cee9a1 0363-0360 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20090402 OTC MONOGRAPH NOT FINAL part334 Walgreens MINERAL OIL 15 mL/15mL 0363-0362_7abec99e-33ec-45cc-90cb-85b57e10c247 0363-0362 HUMAN OTC DRUG Wal-Zan Ranitidine TABLET ORAL 20110628 ANDA ANDA200536 Walgreen Company RANITIDINE HYDROCHLORIDE 150 mg/1 0363-0365_45a874d0-b7b7-436d-aea7-76f505625800 0363-0365 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20130322 ANDA ANDA091349 Walgreen Company NICOTINE 2 mg/1 0363-0367_6792e042-6af6-4e77-bddb-dba35d19113c 0363-0367 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 WALGREEN CO. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0363-0368_39b497d4-646d-482d-b36a-3e8d293c45e3 0363-0368 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 19970114 ANDA ANDA074661 Walgreen Company NAPROXEN SODIUM 220 mg/1 0363-0369_40a8c1fc-ef7e-4a1b-8d41-ddd7bf95b2ad 0363-0369 HUMAN OTC DRUG Hydrocortisone maximum strength Hydrocortisone CREAM TOPICAL 20090227 OTC MONOGRAPH NOT FINAL part348 Walgreen Company HYDROCORTISONE 1 g/100g 0363-0372_8a4b81ef-adc2-4335-ab8a-bd2f10d30f25 0363-0372 HUMAN OTC DRUG Mucus Relief Plus Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20020727 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 0363-0373_38f611ac-ce87-4600-839d-bcf4b912a143 0363-0373 HUMAN OTC DRUG Headache Relief PM Acetaminophen and Diphenhydramine Citrate TABLET ORAL 20040607 OTC MONOGRAPH FINAL part338 WALGREEN CO. ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 0363-0374_63289eb2-5192-4a48-9eb4-7fad71b91502 0363-0374 HUMAN OTC DRUG migraine relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20020502 ANDA ANDA075794 Walgreen Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0363-0375_8a82683c-447b-44f9-a5b7-d97f6d728f8e 0363-0375 HUMAN OTC DRUG Anti-Diarrheal Loperamides TABLET ORAL 20050503 ANDA ANDA076497 WALGREEN CO. LOPERAMIDE HYDROCHLORIDE 2 mg/1 0363-0376_a6e2a857-b966-4318-b447-715043428458 0363-0376 HUMAN OTC DRUG Sore throat cherry Phenol SPRAY ORAL 20140831 OTC MONOGRAPH NOT FINAL part356 Walgreens PHENOL 1.4 g/100mL 0363-0378_11702032-8b9e-4a5f-8e41-83289272b2da 0363-0378 HUMAN OTC DRUG advanced firming and anti wrinkle Ensulizole, Octinoxate CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 Walgreen Company ENSULIZOLE; OCTINOXATE 2; 7.5 g/100g; g/100g 0363-0379_1b34fa9f-5b1e-43c3-8125-9c47551e8426 0363-0379 HUMAN OTC DRUG wal dryl allergy childrens Diphenhydramine Hydrochloride LIQUID ORAL 19890715 OTC MONOGRAPH FINAL part341 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 0363-0382_283e8d2a-5acf-4b5c-9428-4add2994f11c 0363-0382 HUMAN OTC DRUG Wal-Finate D Chlorpheniramine maleate, Pseudoephedrine TABLET ORAL 20010521 OTC MONOGRAPH FINAL part341 WALGREEN CO. CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 60 mg/1; mg/1 0363-0384_eac726e8-5dbb-41aa-a3ae-576907b1b543 0363-0384 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120828 ANDA ANDA091135 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 0363-0390_65318f38-44cd-4118-b314-8f447fd3dabc 0363-0390 HUMAN OTC DRUG ephrine nose extra strength Phenylephrine hydrochloride LIQUID NASAL 19951020 OTC MONOGRAPH FINAL part341 Walgreen Company PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 0363-0391_da93a201-1630-4768-98d6-3ee1918292e5 0363-0391 HUMAN OTC DRUG Menstrual Relief Acetaminophen, Caffeine, Pyrilamine maleate CAPSULE, LIQUID FILLED ORAL 20010614 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 0363-0392_4b8bf442-651a-43fa-a09b-d39d84cbc517 0363-0392 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20020330 ANDA ANDA075139 WALGREEN CO. IBUPROFEN 200 mg/1 0363-0393_f37bd88b-8a29-4452-bde6-be952c02de10 0363-0393 HUMAN OTC DRUG Ibuprofen 200 Ibuprofen CAPSULE, COATED ORAL 20020408 ANDA ANDA075139 WALGREEN CO. IBUPROFEN 200 mg/1 0363-0394_fab7f59f-aa4d-4a8b-9d22-cd475ccfbf20 0363-0394 HUMAN OTC DRUG phenylephrine hydrochloride phenylephrine hydrochloride SUPPOSITORY RECTAL 20051201 OTC MONOGRAPH FINAL part346 Walgreen Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2077; 6; 73 mg/1; mg/1; mg/1 0363-0396_01c8472e-e18e-4478-b845-80779589a955 0363-0396 HUMAN OTC DRUG wal tussin dm Dextromethorphan HBr, Guaifenesin LIQUID ORAL 19951006 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 0363-0397_dd999f69-73fe-4a66-9200-f4331cd6ac17 0363-0397 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 20010904 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ASPIRIN 81 mg/1 0363-0400_d8c64882-6264-45a6-af96-4263d3e45b75 0363-0400 HUMAN OTC DRUG Hemorrhoidal Cooling Gel phenylephrine and witch hazel GEL TOPICAL 20060101 OTC MONOGRAPH FINAL part346 Walgreen Company PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/g; g/g 0363-0401_e9d0b6f9-e9f3-431c-9f34-4d63108282a1 0363-0401 HUMAN OTC DRUG Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110808 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 0363-0402_64e1ba10-f315-47f9-ae64-1d47d6e5a241 0363-0402 HUMAN OTC DRUG Walgreen Maximum Strength Diaper Rash ZINC OXIDE OINTMENT TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 WALGREEN COMPANY ZINC OXIDE 400 mg/g 0363-0402_798bc7cd-956d-4936-bb3e-38ce0394308a 0363-0402 HUMAN OTC DRUG Walgreen Maximum Strength Diaper Rash ZINC OXIDE OINTMENT TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 WALGREEN COMPANY ZINC OXIDE 400 mg/g 0363-0403_14912e92-1a99-4158-a42b-ccb4ffa01a66 0363-0403 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 WALGREEN CO. MECLIZINE HYDROCHLORIDE 25 mg/1 0363-0404_8c0c5724-1b04-4b40-b1a8-4ce1bec8ad07 0363-0404 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET, CHEWABLE ORAL 20020529 OTC MONOGRAPH FINAL part336 WALGREEN CO. MECLIZINE HYDROCHLORIDE 25 mg/1 0363-0405_225ef88a-5865-4a37-bbce-f35cfdb66c2c 0363-0405 HUMAN OTC DRUG Well at Walgreens SODIUM BICARBONATE, SODIUM CHLORIDE KIT NASAL 20130401 UNAPPROVED DRUG OTHER Walgreen Company 0363-0407_5e3f402a-34e6-479d-9fd9-cdbacc8bb1b2 0363-0407 HUMAN OTC DRUG Walgreens Cold Sore Treatment Camphor CREAM TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Walgreens BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g 0363-0407_70afbecc-f39b-48d7-9839-907a786a8c29 0363-0407 HUMAN OTC DRUG Walgreens Cold Sore Treatment Camphor CREAM TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part348 Walgreens BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g 0363-0408_734c278c-1b9e-4909-bb6c-64b9af29ce14 0363-0408 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20140831 ANDA ANDA078682 Walgreens IBUPROFEN 200 mg/1 0363-0410_2b7b5560-1aaa-4108-86c4-8de86f6fd527 0363-0410 HUMAN OTC DRUG Mucus Relief Severe Cold Daytime Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL 0363-0411_dcefad7a-5dad-4462-bc2f-57df45fb24c6 0363-0411 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20060223 ANDA ANDA077007 Walgreen Company NICOTINE 2 mg/1 0363-0412_2a6fa219-fa07-4cde-a928-443a03e9120a 0363-0412 HUMAN OTC DRUG Non-Drowsy Wal-Phed PE Triple Relief Aceetaminophen, Guaifenesin and Phenylephrine HCl TABLET ORAL 20050806 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 0363-0413_95e8fbaf-2d4b-4ac6-bfa5-5941fe0a6e2f 0363-0413 HUMAN OTC DRUG Ibuprofen PM Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20100209 ANDA ANDA079113 Walgreen Company DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 0363-0414_b30a696f-86fb-4c91-b3d9-beb093685434 0363-0414 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20040114 OTC MONOGRAPH FINAL part343 WALGREEN CO. ASPIRIN 81 mg/1 0363-0417_d1e25aff-86a5-4add-bb44-1c965079db60 0363-0417 HUMAN OTC DRUG Cough and Chest Congestion DM Maximum Strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Walgreens DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL 0363-0418_a10ade19-ada8-46fd-af71-7576af12d185 0363-0418 HUMAN OTC DRUG Wal-Dryl Allergy Diphenhydramine HCl LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Walgreens DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/10mL 0363-0419_4d32b1af-c12d-476a-96ec-d9fc1a1fab63 0363-0419 HUMAN OTC DRUG Cough Childrens Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 19930409 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 0363-0420_8dad00c0-e8f5-47eb-b468-bef093ecb932 0363-0420 HUMAN OTC DRUG Minoxidil Minoxidil SOLUTION TOPICAL 20110225 ANDA ANDA075357 Walgreen Company MINOXIDIL 2 g/100mL 0363-0422_cba3a5f6-61f1-4ed2-86e7-7347f99efc33 0363-0422 HUMAN OTC DRUG Daytime Nighttime Cold and Cough Childrens Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCl, Phenylephrine HCl KIT 20140930 OTC MONOGRAPH FINAL part341 Walgreens 0363-0423_61e48014-a93d-4512-a34a-1ee16763bad9 0363-0423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, COATED ORAL 20011008 ANDA ANDA074567 Walgreen Company IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 0363-0424_e1a156a3-ef95-479d-8e7e-622d8b728c38 0363-0424 HUMAN OTC DRUG Nicotine Nicotine polacrilex LOZENGE ORAL 20100112 ANDA ANDA090821 Walgreen Company NICOTINE 4 mg/1 0363-0425_e7a5b21a-3c78-4799-b629-2a4220840047 0363-0425 HUMAN OTC DRUG Wal fex Allergy Fexofenadine HCl TABLET, FILM COATED ORAL 20110822 ANDA ANDA076447 Walgreen Company FEXOFENADINE HYDROCHLORIDE 60 mg/1 0363-0426_c05a4413-8a5f-4b91-9c22-b1db785e8e9e 0363-0426 HUMAN OTC DRUG Tioconazole 1 Tioconazole OINTMENT VAGINAL 20071219 ANDA ANDA075915 Walgreen Company TIOCONAZOLE 6.5 g/100g 0363-0428_d1ac4ce7-52aa-4c60-8b39-d9eb2dd2878a 0363-0428 HUMAN OTC DRUG Tension Headache Relief Acetaminophen, Caffeine CAPSULE ORAL 20070117 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 0363-0430_19e08016-d774-4141-8115-c33cfe33f6b4 0363-0430 HUMAN OTC DRUG Eye Allergy Relief Pheniramine Maleate and Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20100831 NDA NDA020065 Walgreen Company NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL 0363-0431_2b7613bd-739c-4034-ac62-c12f2da3ed8a 0363-0431 HUMAN OTC DRUG Extra Strength Back and Body Aspirin, Caffeine CAPSULE ORAL 20040412 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ASPIRIN; CAFFEINE 500; 32.5 mg/1; mg/1 0363-0434_9644cc95-df9e-4dc7-b218-57ac3eee7e03 0363-0434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20131010 OTC MONOGRAPH NOT FINAL part356 Walgreen Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 0363-0438_1cbaab9a-8a36-4001-8820-9a1533acd066 0363-0438 HUMAN OTC DRUG Dye Free Ibuprofen Ibuprofen TABLET ORAL 20040311 ANDA ANDA075139 WALGREEN CO. IBUPROFEN 200 mg/1 0363-0439_57752bd7-db9c-42e2-b2c7-876d09b9da30 0363-0439 HUMAN OTC DRUG Enteric Coated Low Dose Aspirin Aspirin TABLET, COATED ORAL 20040414 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ASPIRIN 81 mg/1 0363-0440_bf5e0afe-a6a5-4e9c-be8a-12cb8c5de14a 0363-0440 HUMAN OTC DRUG Walgreens Children Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20141006 OTC MONOGRAPH NOT FINAL part334 Walgreens GLYCERIN 83 g/100g 0363-0441_83cc3222-6cd4-4c60-9ff2-f411fbfae42a 0363-0441 HUMAN OTC DRUG WAL SOM NIGHTTIME SLEEP AID Doxylamine succinate TABLET ORAL 19990305 ANDA ANDA040167 Walgreen Company DOXYLAMINE SUCCINATE 25 mg/1 0363-0442_1c652bdd-6703-4f1c-a5b0-578874ce705f 0363-0442 HUMAN OTC DRUG Childrens Plus Cough and Sore Throat Acetaminophen,DEXTROMETHORPHAN HYDROBROMIDE SUSPENSION ORAL 20090702 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 5 mg/5mL; mg/5mL 0363-0443_26488c4d-b0bc-40a7-8f2b-32732f47b6ad 0363-0443 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin and Caffeine TABLET, FILM COATED ORAL 20080313 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0363-0444_0709e8e3-9946-46dc-af9a-213d45653958 0363-0444 HUMAN OTC DRUG Nighttime Daytime Cough dextromethorphan HBr, doxylamine succinate KIT 20140225 OTC MONOGRAPH FINAL part341 Walgreen Company 0363-0446_ad1bccff-35aa-4c09-b497-fb4f8e9c7def 0363-0446 HUMAN OTC DRUG NICOTINE nicotine polacrilex LOZENGE ORAL 20110714 NDA NDA021330 Walgreens NICOTINE 2 mg/1 0363-0447_edba5d05-15d1-43e3-accd-fff2eb5bd16f 0363-0447 HUMAN OTC DRUG Childrens Fast-Dissolving Pain and Fever Acetaminophen TABLET, CHEWABLE ORAL 20050203 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN 80 mg/1 0363-0450_b1ff6124-ec0d-4c31-b6b0-057ffbb9b8d8 0363-0450 HUMAN OTC DRUG Junior Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN 160 mg/1 0363-0452_f448cf7f-2d2d-471d-a96b-e2e18fa16d84 0363-0452 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen TABLET, SOLUBLE ORAL 20041206 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN 80 mg/1 0363-0453_a2e61e02-2254-4745-af31-b5df23d83f04 0363-0453 HUMAN OTC DRUG Wal-Phed PE Phenylephrine HCl TABLET, COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 WALGREEN CO. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 0363-0454_484da45d-9abb-4b8c-82be-50592d9c0a1a 0363-0454 HUMAN OTC DRUG tension headache Acetaminophen, Caffeine TABLET, FILM COATED ORAL 20080205 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 0363-0456_b244167a-6977-4081-8463-162b6bd8773c 0363-0456 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061027 ANDA ANDA076777 Walgreen Company NICOTINE 2 mg/1 0363-0458_799aa3e6-f4ce-4fab-85ec-94f5d2793881 0363-0458 HUMAN OTC DRUG Wal Zyr all day allergy Cetirizine Hydrochloride TABLET ORAL 20080109 ANDA ANDA078336 Walgreen Company CETIRIZINE HYDROCHLORIDE 10 mg/1 0363-0459_a8ceb55b-7d4f-48b5-81db-8375607911b8 0363-0459 HUMAN OTC DRUG nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110816 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 0363-0461_aa0617f2-3833-4d28-801c-775aa334c66f 0363-0461 HUMAN OTC DRUG Flu BP Acetaminophen, Dextromethorphan HBr, Chlorpheniramine maleate TABLET, FILM COATED ORAL 20050601 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 500; 2; 15 mg/1; mg/1; mg/1 0363-0462_cd570927-02ac-40b1-af76-fefe97b495bc 0363-0462 HUMAN OTC DRUG Wal-Phed PE Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20050609 OTC MONOGRAPH FINAL part341 WALGREEN CO. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 0363-0470_aabc6f36-032f-4171-b007-6bfc408d14a1 0363-0470 HUMAN OTC DRUG Cold Multi-Symptom Daytime Non-Drowsy Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050715 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 0363-0473_c862c778-85e9-463b-92a2-4adc8500032e 0363-0473 HUMAN OTC DRUG daytime cough non drowsy Dextromethorphan HBr LIQUID ORAL 20091015 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE 15 mg/15mL 0363-0480_23f21e78-9036-44fd-b771-8b2bf55b760e 0363-0480 HUMAN OTC DRUG Oil-Free Daily Face Salicylic Acid CREAM TOPICAL 20140915 OTC MONOGRAPH FINAL part333D Walgreen Company SALICYLIC ACID 2 g/100g 0363-0482_452b8485-2bd8-42dc-97e1-e8b4e7f9b348 0363-0482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20130601 OTC MONOGRAPH FINAL part355 Walgreen Co SODIUM FLUORIDE .1 mg/mL 0363-0484_f6b2d24d-a705-4ec5-a277-e8c0f0c923d2 0363-0484 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20090121 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 500 mg/1 0363-0485_57d55ebf-2adc-4103-8f61-67d768db23c6 0363-0485 HUMAN OTC DRUG Wal-Dryl-D Diphenhydramine HCl and Phenylephrine HCl TABLET ORAL 20050810 OTC MONOGRAPH FINAL part341 WALGREEN CO. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 25; 10 mg/1; mg/1 0363-0490_a28ff1dd-4d63-4547-aa9b-e33361c15aaa 0363-0490 HUMAN OTC DRUG Pain Relief All Day Naproxen Sodium TABLET ORAL 19970114 ANDA ANDA074661 Walgreen Company NAPROXEN SODIUM 220 mg/1 0363-0491_0cd36044-3308-472d-80a3-c9dc3889c568 0363-0491 HUMAN OTC DRUG Wal-Finite Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 WALGREEN CO. CHLORPHENIRAMINE MALEATE 4 mg/1 0363-0495_16625a43-22c1-4754-a7bd-ccc262e2dbd5 0363-0495 HUMAN OTC DRUG Wal Zyr Cetirizine Hydrochloride TABLET ORAL 20080109 ANDA ANDA078336 Walgreen Company CETIRIZINE HYDROCHLORIDE 10 mg/1 0363-0498_c8c5c6b5-9b73-49ac-8533-26a13945251c 0363-0498 HUMAN OTC DRUG Mucus Relief ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130318 ANDA ANDA078912 Walgreen Company GUAIFENESIN 600 mg/1 0363-0500_428d6a02-ff38-4b3b-b301-dca16755064e 0363-0500 HUMAN OTC DRUG Cough Dextromethorphan HBr LIQUID ORAL 20140220 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE 15 mg/15mL 0363-0502_6fd3ba7c-d005-4bc1-a7c4-b95ec4f261af 0363-0502 HUMAN OTC DRUG Wal-Phed PE Maximum Strength, Non-Drowsy Acetaminophen, Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 0363-0503_c5c45299-71d6-40de-9cde-c311ded35106 0363-0503 HUMAN OTC DRUG Daytime Multi-Symptom Severe Cold Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED ORAL 20050804 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 0363-0504_66f343ed-4fe1-4c03-8d34-84f8df1adbb8 0363-0504 HUMAN OTC DRUG Well at Walgreens SODIUM BICARBONATE, SODIUM CHLORIDE KIT NASAL 20130401 UNAPPROVED DRUG OTHER Walgreen Company 0363-0507_695e2435-fea1-4889-a3e8-a71c7dc5688c 0363-0507 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20131209 ANDA ANDA076359 Walgreen Company IBUPROFEN 100 mg/1 0363-0516_8f9bce00-5c29-4916-86d8-e9ffa4fc7706 0363-0516 HUMAN OTC DRUG Wal Tussin Adult Cough and Cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20060714 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 0363-0518_edd442cc-4db5-42a7-a7ee-4159163de7d3 0363-0518 HUMAN OTC DRUG Severe Allergy Acetaminophen and Diphenhydramine HCl TABLET ORAL 20050606 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 12.5 mg/1; mg/1 0363-0519_56fcb241-0a41-4cdd-8b44-b8ae0d49fe8c 0363-0519 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN 500 mg/1 0363-0520_5a88b591-4994-4476-8293-2a0d6be31328 0363-0520 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20120530 NDA NDA021855 Walgreens LOPERAMIDE HYDROCHLORIDE 2 mg/1 0363-0521_bebdc250-07eb-46c5-8de9-4f7ed5e227a4 0363-0521 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20090505 ANDA ANDA076359 Walgreen Company IBUPROFEN 100 mg/1 0363-0522_5abc21be-ea9c-491b-a077-d5a6809f0a4c 0363-0522 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20131205 ANDA ANDA076134 Walgreen Company LORATADINE 10 mg/1 0363-0523_32eb1ff1-07ec-441d-9d1a-a6c05ced4427 0363-0523 HUMAN OTC DRUG Ibuprofen Junior Strength Ibuprofen TABLET, CHEWABLE ORAL 20121218 ANDA ANDA076359 Walgreen Company IBUPROFEN 100 mg/1 0363-0525_e525f6fc-6b1d-4799-a7c2-c6270b6d5fd8 0363-0525 HUMAN OTC DRUG Wal-dryl Itch Relief diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20060118 OTC MONOGRAPH NOT FINAL part348 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; 1 mg/g; mg/g 0363-0526_5a62f571-597c-452f-b827-307c5408c65f 0363-0526 HUMAN OTC DRUG Multi-Symptom Wal-Phed PE Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET, FILM COATED ORAL 20050621 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 0363-0527_15b8b419-43de-48e4-a10a-725ef018564b 0363-0527 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Walgreen Company LORATADINE 10 mg/1 0363-0529_2b022c39-a9f8-4ad4-a0b7-049f5ba5387a 0363-0529 HUMAN OTC DRUG Multi-Symptom Cold Relief Acetaminophen, Chlorpehniramine HCl, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 WALGREEN CO. 0363-0530_a81effb1-2dad-4667-a0aa-ee6149240e84 0363-0530 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20140331 OTC MONOGRAPH FINAL part332 Walgreens DIMETHICONE 180 mg/1 0363-0531_42f9ec3b-7249-43f8-9326-5129f7f6217d 0363-0531 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen TABLET, COATED ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN 500 mg/1 0363-0532_000b6d23-775c-4528-a646-c56b174951be 0363-0532 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20051222 OTC MONOGRAPH FINAL part341 WALGREEN CO. GUAIFENESIN 400 mg/1 0363-0534_fb342c81-f5f5-419d-92e3-aed4e88dbfa3 0363-0534 HUMAN OTC DRUG Daytime Multi-Symptom Non-Drowsy Cold and Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20070919 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 0363-0535_16c88fa5-a730-4300-b21f-ddd9bed9a4a4 0363-0535 HUMAN OTC DRUG Nighttime Multi-Symptom Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20070910 OTC MONOGRAPH NOT FINAL part341 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 0363-0536_6a5339d8-93f2-4f6c-879d-f93d62d1a79f 0363-0536 HUMAN OTC DRUG Walgreens Oil-Free Acne Wash Salicylic Acid SOLUTION TOPICAL 20130105 OTC MONOGRAPH FINAL part333D Walgreens Company SALICYLIC ACID 2 g/100mL 0363-0542_991c4cf3-0aca-4885-bc3b-8231e1110404 0363-0542 HUMAN OTC DRUG Mucus Relief PE Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20060415 OTC MONOGRAPH FINAL part341 WALGREEN CO. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 0363-0543_46bae06a-128c-40b3-a17f-0f2b460f3026 0363-0543 HUMAN OTC DRUG Wal-Dryl Severe Allergy and Sinus Headache Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET ORAL 20070627 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 0363-0544_b656472f-478f-4361-a0d8-fef0302f4977 0363-0544 HUMAN OTC DRUG arthritis pain reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000526 ANDA ANDA075077 Walgreen Company ACETAMINOPHEN 650 mg/1 0363-0546_144ffa07-ba9c-4992-a79b-885e95b320c3 0363-0546 HUMAN OTC DRUG Acid Controller Complete dual action Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080730 ANDA ANDA077355 Walgreen Company CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 0363-0547_2e313f96-37c6-4d03-afa4-454a61099478 0363-0547 HUMAN OTC DRUG Mucus Relief D Guaifenesin, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20070126 OTC MONOGRAPH FINAL part341 WALGREEN CO. GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 400; 40 mg/1; mg/1 0363-0548_569d762d-ed20-49d8-9d91-8d9fea46309a 0363-0548 HUMAN OTC DRUG Wal-Phed PE Non-Drying Sinus Guaifenesin, Phenylephrine HCl TABLET ORAL 20030917 OTC MONOGRAPH FINAL part341 WALGREEN CO. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 200; 5 mg/1; mg/1 0363-0550_1d17ea89-49fd-4c9a-b547-8d1fdb0b7aba 0363-0550 HUMAN OTC DRUG Nighttime D Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Pseudoephedrine HCl LIQUID ORAL 20020619 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1000; 30; 12.5; 60 mg/30mL; mg/30mL; mg/30mL; mg/30mL 0363-0551_1c9084b2-84b3-436b-ab20-b893129c245d 0363-0551 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20030731 OTC MONOGRAPH NOT FINAL part348 Walgreen Co. MENTHOL; ZINC OXIDE 1.5; 10 mg/g; mg/g 0363-0554_e6499ca5-0cdf-4701-8943-a10e738a568d 0363-0554 HUMAN OTC DRUG Nice fresh scent Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Walgreen Co. BENZALKONIUM CHLORIDE .115 g/1 0363-0555_99eb5e5b-4aa9-4fdb-b7bd-53b0b0765e4c 0363-0555 HUMAN OTC DRUG Sinus Relief Daytime Nighttime Acetaminophen, Doxylamine Succinate, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 WALGREEN CO. 0363-0556_b35e05cb-cd30-4fd3-b58f-19727ca8cf01 0363-0556 HUMAN OTC DRUG Extra Strength Pain Reliever PM Acetaminophen, Diphenhydramin HCl CAPSULE, GELATIN COATED ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 0363-0557_1370c061-e2c2-43c2-8abe-f21da4839464 0363-0557 HUMAN OTC DRUG Athletes Foot Miconazole Nitrate SPRAY TOPICAL 20050609 OTC MONOGRAPH FINAL part333C Walgreen Company MICONAZOLE NITRATE 2 g/100g 0363-0558_78cbc26d-468d-4487-abac-be015b11cb82 0363-0558 HUMAN OTC DRUG Sinus Congestion and Pain Daytime Acetaminophen and Phenylephrine HCl CAPSULE ORAL 20080317 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 0363-0559_dd4b669d-01ac-44d6-860c-0fd254fd5df3 0363-0559 HUMAN OTC DRUG Multi-Symptom Allergy Acetaminophen, Phenylephrine HCl, Chlorpheniramine maleate TABLET ORAL 20080317 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 0363-0560_d4a98833-6463-4780-b691-528c23fd8fdf 0363-0560 HUMAN OTC DRUG DayTime Cold Multi-Symptom Acetaminophen, Phenylephrine HCl and Dextromethorphan HBr TABLET ORAL 20080329 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 0363-0563_538fe675-ea9a-45b8-8397-50617c31149a 0363-0563 HUMAN OTC DRUG Enteric Coated Low Dose Aspirin Aspirin TABLET ORAL 20080212 OTC MONOGRAPH NOT FINAL part356 WALGREEN CO. ASPIRIN 81 mg/1 0363-0566_1cce11c3-49dc-4989-8c46-9e35514d8105 0363-0566 HUMAN OTC DRUG Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110816 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 0363-0567_fe60e459-a35b-4dba-873e-96ffd9d0130e 0363-0567 HUMAN OTC DRUG daytime nighttime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120906 OTC MONOGRAPH FINAL part341 Walgreen Company 0363-0571_5813217f-cfb5-46c3-bc32-25a8b7ad0fc5 0363-0571 HUMAN OTC DRUG wal fex allergy fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Walgreen Company FEXOFENADINE HYDROCHLORIDE 180 mg/1 0363-0572_22739321-f349-4017-961d-f45aa06282b3 0363-0572 HUMAN OTC DRUG Tension Headache Relief Acetaminophen, Caffeine CAPSULE, GELATIN COATED ORAL 20090209 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 0363-0578_0d512191-2514-450d-9cc9-44b8bbc1df5e 0363-0578 HUMAN OTC DRUG wal tussin dm adult cough and chest congestion Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19940729 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 0363-0579_f2085b26-5778-4656-8de3-9edd83f914dd 0363-0579 HUMAN OTC DRUG pain reliever fever reducer childrens Acetaminophen SUPPOSITORY RECTAL 20100219 ANDA ANDA070607 Walgreen Company ACETAMINOPHEN 120 mg/1 0363-0582_8e3b7d2b-c7e5-4e30-bc4f-b89680d78814 0363-0582 HUMAN OTC DRUG Vitamin A and D skin protectant Lanolin, Petrolatum OINTMENT TOPICAL 20090819 OTC MONOGRAPH FINAL part347 Walgreen Company LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g 0363-0583_5635d0ca-560d-451d-b533-3b4caebb5161 0363-0583 HUMAN OTC DRUG Wal-Dryl Allergy Plus Cold Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl CAPSULE ORAL 20090710 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 0363-0585_f1601aa7-eb66-4c3b-ada1-208fe6e6c13f 0363-0585 HUMAN OTC DRUG Childrens Wal-Dryl Allergy Diphenhydramine HCl TABLET, CHEWABLE ORAL 20090320 OTC MONOGRAPH FINAL part341 WALGREEN CO. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 0363-0587_3ef4ade7-2807-40a8-b524-af34b604dc9e 0363-0587 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET, COATED ORAL 20090318 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ASPIRIN 81 mg/1 0363-0588_b862113a-3612-49a3-b4b6-79d56bdc61e0 0363-0588 HUMAN OTC DRUG cough relief nighttime Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20020816 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 0363-0590_cf6523a7-f668-42f9-ba1a-df77d7baecb1 0363-0590 HUMAN OTC DRUG pain and fever acetaminophen SUSPENSION ORAL 19930430 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL 0363-0591_513a3f14-9d11-48ef-aff0-79834981c5b8 0363-0591 HUMAN OTC DRUG Multi-Symptom Nighttime Cold Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, GELATIN COATED ORAL 20080329 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 0363-0595_416d3ef9-7d36-4f58-815e-178e17d10521 0363-0595 HUMAN OTC DRUG Childrens Wal Zyr 24 Hour Allergy cetirizine Hydrochloride LIQUID ORAL 20101015 ANDA ANDA090254 Walgreen Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 0363-0599_18746199-abd6-4a7b-b2d3-b054b7a9089b 0363-0599 HUMAN OTC DRUG Childrens Wal-Dryl Allergy Diphenhydramine TABLET, CHEWABLE ORAL 20110425 OTC MONOGRAPH FINAL part338 WALGREEN CO. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 0363-0600_87c8c19f-25c2-4185-a574-fe460c9896b4 0363-0600 HUMAN OTC DRUG Wal Fex 24 Hour Allergy fexofenadine hcl TABLET, FILM COATED ORAL 20140306 ANDA ANDA076447 Walgreen Company FEXOFENADINE HYDROCHLORIDE 180 mg/1 0363-0601_9722369a-5cde-43c4-b262-71c20929a9ba 0363-0601 HUMAN OTC DRUG Walgreens Wal-Flu Cold and Sore Throat Lemon Flavor Acetaminophen, Pheniramine Maleate, Phenylephrine HCl GRANULE, FOR SOLUTION ORAL 20131007 OTC MONOGRAPH FINAL part341 Walgreen Co. ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 20; 10 mg/1; mg/1; mg/1 0363-0602_5db5c520-d7c4-4f57-b328-5b83c29bb3f8 0363-0602 HUMAN OTC DRUG Walgreens Sugar Free Nighttime Wal-Flu severe cold and cough Natural honey lemon flavor Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20140915 OTC MONOGRAPH FINAL part341 Walgreen Co. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 0363-0603_54254b61-7861-4eeb-bd3c-54fd5266f4a7 0363-0603 HUMAN OTC DRUG Severe Cold and Flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20131121 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 0363-0604_37c9b887-190a-4daf-8199-f406913132f0 0363-0604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090121 ANDA ANDA072096 Walgreen Company IBUPROFEN 200 mg/1 0363-0605_33401fdb-f41b-4214-8907-e58d483e9e5f 0363-0605 HUMAN OTC DRUG Miconazole 3 Miconazole nitrate KIT 20050708 ANDA ANDA075329 Walgreen Company 0363-0608_cbdeda20-031e-4f00-9902-e38e51f50ec1 0363-0608 HUMAN OTC DRUG Extra Strength Gas Relief Simethicone TABLET ORAL 20130701 OTC MONOGRAPH FINAL part332 WALGREEN CO. DIMETHICONE 125 mg/1 0363-0609_9fe2bc4c-8697-4c9a-ab48-fe15bb61c104 0363-0609 HUMAN OTC DRUG Nighttime D Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID ORAL 20020628 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 500; 15; 6.25; 30 mg/15mL; mg/15mL; mg/15mL; mg/15mL 0363-0610_d186b442-7413-4447-b3f1-c3c82fb4e258 0363-0610 HUMAN OTC DRUG EYE ITCH RELIEF Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20120501 ANDA ANDA077958 Walgreens KETOTIFEN FUMARATE .25 mg/mL 0363-0611_aebce79a-f4d2-4e03-983f-f4b4670cf78d 0363-0611 HUMAN OTC DRUG Ibuprofen PM Diphenhydramine hydrochloride, ibuprofen CAPSULE, LIQUID FILLED ORAL 20130708 ANDA ANDA200888 WALGREEN CO. DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25; 200 mg/1; mg/1 0363-0612_a1d13341-f54d-400c-bc47-725145e15d48 0363-0612 HUMAN OTC DRUG Wal Itin Loratadine TABLET ORAL 20090213 ANDA ANDA076301 Walgreen Company LORATADINE 10 mg/1 0363-0615_2dadd814-235b-4860-8604-41c32b3a0769 0363-0615 HUMAN OTC DRUG wal zyr Ketotifen SOLUTION OPHTHALMIC 20100312 ANDA ANDA077958 Walgreen Company KETOTIFEN FUMARATE .25 mg/mL 0363-0616_d841a808-9a80-45bf-85a6-d885337e4a6e 0363-0616 HUMAN OTC DRUG Maximum Strength Mucus Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 0363-0617_675e7735-8a9f-40c6-93df-786709201729 0363-0617 HUMAN OTC DRUG Wal itin D 12 hour allergy and congestion Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120118 ANDA ANDA076050 Walgreen Company LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 0363-0619_d5b3ed5a-bf6c-4d7c-96c1-eb12c2d11db3 0363-0619 HUMAN OTC DRUG Daily Moisturizing Daily Moistruizing LOTION TOPICAL 20130206 OTC MONOGRAPH FINAL part347 Walgreen DIMETHICONE 13 mg/g 0363-0627_3df2a341-523f-4d82-8352-fbc3e85dcc9f 0363-0627 HUMAN OTC DRUG Dye Free NIghttime Sleep Aid Diphenhydramine HCl TABLET ORAL 20130701 OTC MONOGRAPH FINAL part338 WALGREEN CO. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0363-0630_72f422b9-5c1e-47e7-b402-2e09bb29b0ff 0363-0630 HUMAN OTC DRUG Walgreens Anticavity and Antigingivitis Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20081124 OTC MONOGRAPH FINAL part355 Walgreen SODIUM FLUORIDE 2.43 mg/g 0363-0631_15482811-438f-44dd-97a3-a3d4eb07a609 0363-0631 HUMAN OTC DRUG Walgreens Maximum Strength Sensitive Fluoride Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20060606 OTC MONOGRAPH NOT FINAL part356 Walgreens POTASSIUM NITRATE; SODIUM FLUORIDE 5; 2.43 mg/g; mg/g 0363-0632_584bfed6-dcfd-4e44-b171-5b61e94af611 0363-0632 HUMAN OTC DRUG Walgreen Sensitive Extra Whitening Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20061206 OTC MONOGRAPH NOT FINAL part356 Walgreen POTASSIUM NITRATE; SODIUM FLUORIDE 5; 2.43 mg/g; mg/g 0363-0633_28140cfe-89d2-497f-a7c4-778557cf3de0 0363-0633 HUMAN OTC DRUG Walgreens Anticavity and Antigingivitis Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110419 OTC MONOGRAPH FINAL part355 Walgreen SODIUM FLUORIDE 2.43 mg/g 0363-0634_e1d1b140-504b-4ddd-b34a-a825872db017 0363-0634 HUMAN OTC DRUG Walgreen Anticavity Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20090211 OTC MONOGRAPH FINAL part355 Walgreen SODIUM FLUORIDE 2.43 mg/g 0363-0635_347b11b1-98e7-44ac-9b83-67df07769995 0363-0635 HUMAN OTC DRUG Extra Strength Gas Relief Simethicone TABLET ORAL 20131001 OTC MONOGRAPH FINAL part332 WALGREEN CO. DIMETHICONE 125 mg/1 0363-0637_aacb0b61-e899-4e84-826b-c696acaf5235 0363-0637 HUMAN OTC DRUG Miconazole 3 Miconazole nitrate KIT 20040719 ANDA ANDA076357 Walgreen Company 0363-0640_bc81722c-1591-4562-bf4c-cffdd051031f 0363-0640 HUMAN OTC DRUG Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET ORAL 20131031 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 0363-0645_a555efad-e756-4fb0-bad5-692b4c042479 0363-0645 HUMAN OTC DRUG loperamide hydrochloride loperamide HCl LIQUID ORAL 20120518 ANDA ANDA091292 Walgreen Company LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 0363-0648_140abac0-43c9-46a4-8991-fa5e75ee35a2 0363-0648 HUMAN OTC DRUG Wal Four Phenylephrine hydrochloride SPRAY NASAL 20020920 OTC MONOGRAPH FINAL part341 Walgreen Company PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 0363-0650_254aacab-e0d6-4eda-a5ed-c9471b59bea7 0363-0650 HUMAN OTC DRUG All Day Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130523 ANDA ANDA076518 Walgreen Company NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 0363-0656_47c47468-5358-451e-aaa0-0a1b0e547528 0363-0656 HUMAN OTC DRUG Daytime Cold and Flu Relief Non Drowsy acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20060707 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 0363-0657_3f8ffe8c-182b-4f0e-9eff-8b75ff4f6ee9 0363-0657 HUMAN OTC DRUG gas relief Simethicone CAPSULE, LIQUID FILLED ORAL 20020726 OTC MONOGRAPH FINAL part332 Walgreen Company DIMETHICONE 180 mg/1 0363-0660_3e691d89-a73a-4acc-9597-ac007214427d 0363-0660 HUMAN OTC DRUG Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20020325 ANDA ANDA074937 Walgreen Company IBUPROFEN 100 mg/5mL 0363-0663_c6f2e000-5661-4ef8-a7ac-b7dd5f6dd2f1 0363-0663 HUMAN OTC DRUG Crisp Apple Hand Sani Ethyl Alcohol LIQUID TOPICAL 20140123 OTC MONOGRAPH NOT FINAL part333A Walgreen CO ALCOHOL 585 g/mL 0363-0664_a5203ea8-0b1f-4498-96dc-4c9a4d18a75a 0363-0664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19930324 OTC MONOGRAPH NOT FINAL part356 Walgreens Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 0363-0666_c5cb09d4-c049-461c-8898-2c5bb6a8a138 0363-0666 HUMAN OTC DRUG Cold and Flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20140207 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 0363-0667_e675dba1-d558-49c0-873d-ee3ab74fbe01 0363-0667 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 19890715 OTC MONOGRAPH NOT FINAL part334 Walgreen Co MAGNESIUM CITRATE 1.745 g/29.6mL 0363-0668_ed67c35e-c7e2-4240-95fa-1fcbd1f2ba13 0363-0668 HUMAN OTC DRUG Nighttime Cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20020816 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 6.25 mg/15mL; mg/15mL 0363-0673_99583d49-f767-4d85-b8c4-5edf2f159625 0363-0673 HUMAN OTC DRUG Anti Itch Benzocaine, Resorcinol CREAM TOPICAL 20060302 OTC MONOGRAPH NOT FINAL part348 Walgreen Company BENZOCAINE; RESORCINOL 5; 2 g/100g; g/100g 0363-0678_670e5428-570a-4440-8a26-3a29830220af 0363-0678 HUMAN OTC DRUG hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20121026 OTC MONOGRAPH FINAL part346 Walgreen Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 0363-0685_319651f0-d86b-46e5-963c-c1c4f8551e07 0363-0685 HUMAN OTC DRUG Ibuprofen Ibuprofen LIQUID ORAL 20080724 ANDA ANDA074937 Walgreen Company IBUPROFEN 100 mg/5mL 0363-0689_9667e73f-80e3-4647-986b-2d60de1c6a25 0363-0689 HUMAN OTC DRUG Cough Relief Daytime Dextromethorphan HBr LIQUID ORAL 20091015 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE 15 mg/15mL 0363-0692_a8763a67-cd36-45ac-a02c-2966d6c6b3c1 0363-0692 HUMAN OTC DRUG Walgreens 7-in-1 Anti-Aging Vitamin Complex Broad Spectrum SPF 15 Sunscreen Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20130105 OTC MONOGRAPH NOT FINAL part352 Walgreen Company AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 mg/100mL; mg/100mL; mg/100mL 0363-0693_4f9abeed-fc58-40da-86e2-0fb484e2175d 0363-0693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20000714 OTC MONOGRAPH NOT FINAL part334 Walgreens Co MAGNESIUM CITRATE 1.745 g/29.6mL 0363-0695_c86ab353-75fb-496c-a812-04a0679edaf7 0363-0695 HUMAN OTC DRUG jock itch Tolnaftate SPRAY TOPICAL 20050608 OTC MONOGRAPH FINAL part333C Walgreen Company TOLNAFTATE 1 g/100g 0363-0696_e0cb3430-1364-4a06-8d14-12559d314c0c 0363-0696 HUMAN OTC DRUG Walgreens Anti-Sagging and Ultra Hydrating Day Cream Broad Spectrum SPF15 Sunscreen Avobenzone, Benzophenone-3, Octinoxate CREAM TOPICAL 20130105 OTC MONOGRAPH NOT FINAL part352 Walgreen Company AVOBENZONE; OCTINOXATE; OXYBENZONE 3; 10; 2 g/100g; g/100g; g/100g 0363-0698_7ecd199e-79ed-4578-8698-09ca6d337a58 0363-0698 HUMAN OTC DRUG cold and cough Acetaminophen, Dextromethorphan HBr LIQUID ORAL 20110909 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 500; 15 mg/15mL; mg/15mL 0363-0699_22d904f7-780b-4143-8584-9b4f8c155ad3 0363-0699 HUMAN OTC DRUG Wal itin Loratadine TABLET ORAL 20090213 ANDA ANDA076301 Walgreen Company LORATADINE 10 mg/1 0363-0701_42392cb1-7958-4a2f-8622-f00f02afd961 0363-0701 HUMAN OTC DRUG Acid Controller Famotidine TABLET ORAL 20060926 ANDA ANDA077351 Walgreen Company FAMOTIDINE 20 mg/1 0363-0702_6de75dcf-30c1-4acc-a722-967c91676e4f 0363-0702 HUMAN OTC DRUG wal tussin dm max Dextromethorphan HBr, Guaifenesin SUSPENSION ORAL 20141031 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 0363-0704_2675ee1a-9a81-4b02-979c-7e7c673a1d32 0363-0704 HUMAN OTC DRUG wal tussin cf cough and cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20060714 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 0363-0706_daaad04e-4fe8-40ce-9022-1115e9f3a42a 0363-0706 HUMAN OTC DRUG childrens fever reducer Acetaminophen SUPPOSITORY RECTAL 20100219 ANDA ANDA070607 Walgreen Company ACETAMINOPHEN 120 mg/1 0363-0707_a049607d-f5b1-4cdd-ada0-71003dd843ab 0363-0707 HUMAN OTC DRUG wal hist 12 hour relief Clemastine fumarate TABLET ORAL 19960531 ANDA ANDA074512 Walgreen Company CLEMASTINE FUMARATE 1.34 mg/1 0363-0708_5e8495f7-bdc3-4d27-ad2a-9de4e463f7c7 0363-0708 HUMAN OTC DRUG childrens wal tap dm cough and cold Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20070309 OTC MONOGRAPH FINAL part341 Walgreen Company BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 0363-0709_42db981b-04e7-4191-9bcd-b9a3c7ca3347 0363-0709 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20130322 ANDA ANDA091354 Walgreen Company NICOTINE 4 mg/1 0363-0724_19633bbd-ea34-4baa-a5c6-708c3af2bca8 0363-0724 HUMAN OTC DRUG wal itin d non drowsy Pseudoephedrine sulfate, Loratadine TABLET, FILM COATED ORAL 20090324 ANDA ANDA075989 Walgreen Company LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 0363-0725_8442e7de-7ea2-4939-bc35-99345f42796a 0363-0725 HUMAN OTC DRUG Loratadine and Pseudoephedrine Loratadine and Pseudoephedrine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131107 ANDA ANDA076557 Walgreen Company LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 0363-0730_ed6c4d2a-3d0e-4783-9d38-56db897a4052 0363-0730 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20001201 ANDA ANDA074164 Walgreen Company MICONAZOLE NITRATE 2 g/100g 0363-0731_1847f0f6-e882-4c4a-a9ac-3da0ad27f9e8 0363-0731 HUMAN OTC DRUG Baby Petroleum Petrolatum JELLY TOPICAL 20140717 OTC MONOGRAPH FINAL part347 Walgreen Company PETROLATUM 100 g/100g 0363-0734_95799f41-aa5c-4540-8b90-5f5ebe136332 0363-0734 HUMAN OTC DRUG nicotine mini Nicotine Polacrilex LOZENGE ORAL 20130119 ANDA ANDA203690 Walgreen Company NICOTINE 2 mg/1 0363-0737_3a539bab-0b35-41dd-b902-1ad129f7f8d2 0363-0737 HUMAN OTC DRUG Miconazole 1 Miconazole nitrate KIT 20100608 ANDA ANDA079114 Walgreen Company 0363-0739_f6150a67-4214-3f90-63c3-b71084320909 0363-0739 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202194 Walgreen Co LANSOPRAZOLE 15 mg/1 0363-0742_87b78eed-95cf-4b11-be1a-39f1ded8baf7 0363-0742 HUMAN OTC DRUG naproxen sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20101130 NDA NDA021920 Walgreen Company NAPROXEN SODIUM 220 mg/1 0363-0751_f859f876-1c7a-4f41-bf2a-7831a7bf0fe1 0363-0751 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin, Caffeine CAPSULE, GELATIN COATED ORAL 20090109 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0363-0759_04b87dba-0fbc-4980-8bbb-0b80549f4492 0363-0759 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 20100215 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL 0363-0763_02f3e739-3153-412f-b2cd-6f01dcd5875b 0363-0763 HUMAN OTC DRUG Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl LIQUID ORAL 20131121 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 0363-0766_48ba5e49-269f-4f3d-aca8-9387d4febd86 0363-0766 HUMAN OTC DRUG pain and fever Acetaminophen LIQUID ORAL 20111104 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL 0363-0773_a67aeb11-89f0-4f62-8348-414dc7d23444 0363-0773 HUMAN OTC DRUG Walgreens Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20010423 UNAPPROVED DRUG OTHER Walgreens Co PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 0363-0784_948db28c-0e48-5f06-3815-793322644b38 0363-0784 HUMAN OTC DRUG Wal-Fex Fexofenadine hydrochloride TABLET ORAL 20110413 ANDA ANDA076502 Walgreens Company FEXOFENADINE HYDROCHLORIDE 180 mg/1 0363-0798_7c604242-c352-44f3-81cd-cb4790068d3d 0363-0798 HUMAN OTC DRUG minoxidil for men Minoxidil SOLUTION TOPICAL 20091113 ANDA ANDA075598 Walgreen Company MINOXIDIL 3 g/60mL 0363-0799_949ecc3f-49da-4fca-83d6-44613584651b 0363-0799 HUMAN OTC DRUG wal tussin cough and chest congestion Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20100126 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/5mL; mg/5mL 0363-0800_321ab39f-4dca-45e2-a2fc-e4ebfbe9743d 0363-0800 HUMAN OTC DRUG childrens pain and fever Acetaminophen SUSPENSION ORAL 19931008 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL 0363-0801_8be31c7b-c543-4772-9717-15b87e4149fa 0363-0801 HUMAN OTC DRUG Well at Walgreens SODIUM BICARBONATE, SODIUM CHLORIDE POWDER, FOR SOLUTION ORAL 20130401 UNAPPROVED DRUG OTHER Walgreen Company SODIUM BICARBONATE; SODIUM CHLORIDE 700; 2300 mg/3000mg; mg/3000mg 0363-0802_29d4e6d1-6c70-4305-8303-1cf6703e8ad9 0363-0802 HUMAN OTC DRUG Well at Walgreens SODIUM BICARBONATE, SODIUM CHLORIDE POWDER, FOR SOLUTION NASAL 20130401 UNAPPROVED DRUG OTHER Walgreen Company SODIUM BICARBONATE; SODIUM CHLORIDE 700; 2300 mg/3000mg; mg/3000mg 0363-0804_aa7b6547-b618-49d5-9c33-3b10f56d1218 0363-0804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19910315 OTC MONOGRAPH NOT FINAL part333A Walgreen Co ISOPROPYL ALCOHOL .91 mg/mL 0363-0806_397c84f3-2ffc-41e8-aefb-cc0b46afc7e7 0363-0806 HUMAN OTC DRUG Childrens Ibuprofen 100 Dye Free Ibuprofen SUSPENSION ORAL 20140224 ANDA ANDA074937 Walgreen Company IBUPROFEN 100 mg/5mL 0363-0807_50cab290-a178-4917-ba05-5b914361b32e 0363-0807 HUMAN OTC DRUG Cold and Flu Nighttime D Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Pseudoephedrine HCl LIQUID ORAL 20140205 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1000; 30; 12.5; 60 mg/30mL; mg/30mL; mg/30mL; mg/30mL 0363-0809_e0f12d59-1d59-4374-b74f-ea16eafec66a 0363-0809 HUMAN OTC DRUG Walgreen Alcohol Isopropyl Alcohol SWAB TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Walgreen Company ISOPROPYL ALCOHOL 70 mL/100mL 0363-0815_a3c5128b-208f-43cd-9cd7-c0287566ea10 0363-0815 HUMAN OTC DRUG Walgreens Advanced Anti-Wrinkle and Firming Day Cream Broad Spectrum SPF18 Sunscreen Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20121215 OTC MONOGRAPH NOT FINAL part352 Walgreen Company AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 5 g/100g; g/100g; g/100g 0363-0817_b166cbb3-c071-4604-ba8c-444eea802de5 0363-0817 HUMAN OTC DRUG Anefrin Nasal oxymetazoline hydrochloride SPRAY NASAL 20090828 OTC MONOGRAPH FINAL part341 Walgreen Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 0363-0818_e772a739-2e69-41a3-832a-dc743ba5b417 0363-0818 HUMAN OTC DRUG daytime Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20100928 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/15mL; mg/15mL 0363-0819_39f876d3-9029-4a5a-b819-c908306ad544 0363-0819 HUMAN OTC DRUG Walgreens Medicated Callus Removers SALICYLIC ACID DISC TOPICAL 20130601 OTC MONOGRAPH FINAL part358F WALGREENS Co. SALICYLIC ACID 17.67 mg/1 0363-0822_d9d1dd0f-5697-439e-b6e5-8ad604450b94 0363-0822 HUMAN OTC DRUG Multi Antibiotic with Pain Relief Maximum Strength Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20000323 OTC MONOGRAPH NOT FINAL part347 Walgreen Company NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 0363-0823_98f82988-f3ee-4fbe-864c-a9e7d67e21e1 0363-0823 HUMAN OTC DRUG Triple Antibiotic with Pain Relief Maximum Strength bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride OINTMENT TOPICAL 20100312 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 0363-0828_d8a8b76f-c6e5-40f8-bddc-350d4cca9e5e 0363-0828 HUMAN OTC DRUG WALGREENS PINK GRAPEFRUIT SALICYLIC ACID LIQUID TOPICAL 20131217 OTC MONOGRAPH FINAL part333D WALGREEN COMPANY SALICYLIC ACID 20 mg/mL 0363-0829_eadf8b3a-7b54-48c6-970c-3fdcb29e43d7 0363-0829 HUMAN OTC DRUG WELL AT WALGREENS PINK GRAPEFRUIT SALICYLIC ACID LIQUID TOPICAL 20131231 OTC MONOGRAPH FINAL part333D WALGREEN COMPANY SALICYLIC ACID 20 mg/mL 0363-0831_a6db18ed-e67e-48b7-8c1d-ddda0e6e9350 0363-0831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 19940616 OTC MONOGRAPH NOT FINAL part334 Walgreen Co MINERAL OIL 999 mg/mL 0363-0835_28b01cc6-6b28-4e92-a51b-49e5924bb48c 0363-0835 HUMAN OTC DRUG Walgreens Intense Toothache Benzocaine PASTE, DENTIFRICE TOPICAL 20110120 OTC MONOGRAPH FINAL part333B walgreens BENZOCAINE 20 g/100g 0363-0838_0a65ae0f-b829-46b1-9e6d-4a9fae91eb68 0363-0838 HUMAN OTC DRUG Severe Oral Pain Reliever Benzocaine LIQUID ORAL 20120110 OTC MONOGRAPH FINAL part333B Walgreens BENZOCAINE 20 g/100g 0363-0839_47688d76-0a17-4a49-8511-ce2688165a5c 0363-0839 HUMAN OTC DRUG Severe Cold and Flu acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20131121 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 0363-0843_ce140374-4b4b-445d-a29c-b0b3bac49a6e 0363-0843 HUMAN OTC DRUG Hemorrhoidal Cooling Phenylephrine HCl, Witch hazel GEL TOPICAL 20110719 OTC MONOGRAPH FINAL part346 Walgreen Company PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/100g; g/100g 0363-0851_6b7b9de7-3da5-4d0e-9e45-5639018e0887 0363-0851 HUMAN OTC DRUG Antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20021120 OTC MONOGRAPH FINAL part332 Walgreen Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 0363-0854_53fed1b7-c040-4bfd-966b-38b5fcd52ab1 0363-0854 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20070910 ANDA ANDA078546 Walgreen Company NICOTINE 4 mg/1 0363-0855_6637c87b-a357-4106-b21b-e8eac41dd1f7 0363-0855 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20140124 OTC MONOGRAPH NOT FINAL part356 Walgreen Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 0363-0856_0c6963a0-b16a-47c6-8a85-ce792943b4d9 0363-0856 HUMAN OTC DRUG Minoxidil Minoxidil SOLUTION TOPICAL 20060914 ANDA ANDA075357 Walgreen Company MINOXIDIL 2 g/100mL 0363-0866_a6809fc5-5e3a-40bc-9c5d-9c6b8e5245db 0363-0866 HUMAN OTC DRUG lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070910 OTC MONOGRAPH FINAL part358G Walgreen Company PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 0363-0871_25b3924a-5a23-40b2-bdb6-9645fb415522 0363-0871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19960327 OTC MONOGRAPH NOT FINAL part333A Walgreens Co. HYDROGEN PEROXIDE .3 kg/100L 0363-0872_25a0faba-cad1-4c8a-bf40-bfd10dad45ae 0363-0872 HUMAN OTC DRUG cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120807 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 0363-0873_2734a922-2595-433c-9fb6-77da0d42fab6 0363-0873 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20060223 ANDA ANDA077007 Walgreen Company NICOTINE 4 mg/1 0363-0878_27b0ac5e-ada2-4f85-995a-862f0a481ffb 0363-0878 HUMAN OTC DRUG anti itch Hydrocortisone LOTION TOPICAL 20120327 OTC MONOGRAPH NOT FINAL part348 Walgreen Company HYDROCORTISONE 1 g/100g 0363-0884_ce216819-a8cf-4128-80ea-299725d56d9f 0363-0884 HUMAN OTC DRUG Wal Zyr Childrens cetirizine Hydrochloride LIQUID ORAL 19890815 ANDA ANDA090254 Walgreen Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 0363-0889_c01307de-f13a-42ca-93d3-cc561b3aa8be 0363-0889 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 19891215 OTC MONOGRAPH FINAL part347 Walgreen Co PETROLATUM 1 mg/g 0363-0891_6bd9dd4a-2e4b-49cc-adc6-1db122855b00 0363-0891 HUMAN OTC DRUG athletes foot medicated antifungal Tolnaftate SPRAY TOPICAL 20040910 OTC MONOGRAPH FINAL part333C Walgreen Company TOLNAFTATE 1 g/100g 0363-0897_d5d80f62-bfc4-4f71-998d-85de52a9c28c 0363-0897 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990311 ANDA ANDA074937 Walgreen Company IBUPROFEN 100 mg/5mL 0363-0901_f7db348d-7a57-4514-96f7-2879562ded75 0363-0901 HUMAN OTC DRUG Baby TALC POWDER TOPICAL 20140717 OTC MONOGRAPH NOT FINAL part347 Walgreen Company TALC 100 g/100g 0363-0902_2b2b2e27-fa4f-4fb1-93d7-b1020758a665 0363-0902 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090107 OTC MONOGRAPH FINAL part333 Walgreens ISOPROPYL ALCOHOL 70 mL/100mL 0363-0903_15ad58b4-4056-4602-a663-d600224ae92d 0363-0903 HUMAN OTC DRUG Wal Fex Allergy Fexofenadine HCl TABLET, FILM COATED ORAL 20110822 ANDA ANDA076447 Walgreen Company FEXOFENADINE HYDROCHLORIDE 60 mg/1 0363-0906_1be4da85-2b3c-4239-9ac0-6593a60de5e9 0363-0906 HUMAN OTC DRUG wal tap elixir childrens phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20070314 OTC MONOGRAPH FINAL part341 Walgreen Company BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 0363-0908_569961e3-06a5-49be-9426-56817093b4f7 0363-0908 HUMAN OTC DRUG Nighttime Cold and Flu Relief acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20060616 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 0363-0911_c6782f34-7d88-413b-aab7-73e1d2a683c4 0363-0911 HUMAN OTC DRUG Pure Cornstarch Baby Corn Starch POWDER TOPICAL 20140717 OTC MONOGRAPH NOT FINAL part348 Walgreen Company STARCH, CORN 99 g/100g 0363-0912_a0fbe78f-2594-41cc-9eeb-40a68803d10f 0363-0912 HUMAN OTC DRUG Multi-Symptom Cold and Cough Daytime Nighttime Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 WALGREEN CO. 0363-0915_114feb63-20b5-4606-be7d-b96143b64234 0363-0915 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080227 NDA NDA022032 Walgreen Company OMEPRAZOLE 20 mg/1 0363-0916_5db599ea-cd91-4734-95ea-ec4903edd6f9 0363-0916 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20111215 ANDA ANDA079114 Walgreen Company 0363-0917_e7a33540-dd67-43b9-a50b-3aa88edcb837 0363-0917 HUMAN OTC DRUG Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20131227 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 0363-0919_29d38ae6-4401-460f-a713-fdc9c5e3af24 0363-0919 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20140318 ANDA ANDA078546 Walgreen Company NICOTINE 4 mg/1 0363-0923_d729d9fa-393a-4cd2-80af-a2be9513e0d7 0363-0923 HUMAN OTC DRUG eye itch relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20100813 ANDA ANDA077958 Walgreen Company KETOTIFEN FUMARATE .25 mg/mL 0363-0926_f7115d98-727f-464a-af1a-1e328ac5630d 0363-0926 HUMAN OTC DRUG Walgreens Chap Aid Cherry Lip Balm Padimate O, Petrolatum STICK TOPICAL 20010424 OTC MONOGRAPH NOT FINAL part352 Walgreen Company PADIMATE O; PETROLATUM 15; 450 mg/g; mg/g 0363-0927_8269487c-bdd3-4867-871f-a141d622b83c 0363-0927 HUMAN OTC DRUG Walgreens Chap Aid Regular Lip Balm Padimate O, Petrolatum STICK TOPICAL 20000815 OTC MONOGRAPH NOT FINAL part352 Walgreen Company PADIMATE O; PETROLATUM 15; 450 mg/g; mg/g 0363-0928_ccdf73bf-8c90-492e-b577-4a84665e6f6d 0363-0928 HUMAN OTC DRUG Walgreens Chap Aid Lip Balm Strawberry Banana Padimate O, Petrolatum STICK TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Walgreen Company PADIMATE O; PETROLATUM 15; 450 mg/g; mg/g 0363-0929_f777bc3f-f34f-4654-a801-82e3c2b0090f 0363-0929 HUMAN OTC DRUG Wal Zyr D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20131206 ANDA ANDA077170 Walgreen Company CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 0363-0934_ec521461-a427-4722-8c38-9fa08c9df46f 0363-0934 HUMAN OTC DRUG wal tussin dm max cough and chest congestion dextromethorphan hbr, guaifenesin SUSPENSION ORAL 20120119 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 0363-0938_f766aad9-bfd7-459f-8885-e075583d4269 0363-0938 HUMAN OTC DRUG all day pain relief Naproxen Sodium TABLET ORAL 20140731 ANDA ANDA074661 Walgreen Company NAPROXEN SODIUM 200 mg/1 0363-0939_00d77cbb-bdd6-4aee-9095-7c836e377f7c 0363-0939 HUMAN OTC DRUG Apothecary PVP Topical Povidone-Iodine SOLUTION TOPICAL 20110613 OTC MONOGRAPH NOT FINAL part333A Walgreen Company POVIDONE-IODINE 10 mL/100mL 0363-0941_0cadb4d7-b29d-4dbb-a561-3e701629bb92 0363-0941 HUMAN OTC DRUG Advanced Healing Petrolatum OINTMENT TOPICAL 20080328 OTC MONOGRAPH FINAL part347 Walgreen Co PETROLATUM .34 g/g 0363-0944_f303936e-e00e-4956-9af6-1331a4648f7b 0363-0944 HUMAN OTC DRUG hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20110117 OTC MONOGRAPH FINAL part346 Walgreen Company GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g 0363-0946_1061c1cf-6b36-4db0-8b1a-37d2c24e135d 0363-0946 HUMAN OTC DRUG pain and fever infants Acetaminophen SUSPENSION ORAL 20110822 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL 0363-0949_9be44971-0b55-46ae-9c1e-ee1087ac8a2a 0363-0949 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 20130508 OTC MONOGRAPH NOT FINAL part334 Walgreen Company MAGNESIUM HYDROXIDE 1200 mg/15mL 0363-0950_ce2000cd-f999-44d4-b6b0-40199bb70ccd 0363-0950 HUMAN OTC DRUG wal zan 150 Ranitidine TABLET, FILM COATED ORAL 20110917 ANDA ANDA091429 Walgreen Company RANITIDINE HYDROCHLORIDE 150 mg/1 0363-0955_2fad4a7f-1f1a-430b-b8b0-14612fd2ea2a 0363-0955 HUMAN OTC DRUG lice treatment Permethrin LOTION TOPICAL 20100715 ANDA ANDA076090 Walgreen Company PERMETHRIN 1 mg/100mL 0363-0957_0ca34747-12e4-43be-bebc-7076fede2001 0363-0957 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20130119 ANDA ANDA203690 Walgreen Company NICOTINE 4 mg/1 0363-0958_1254f10e-da74-4fa4-bd9c-5b1e5fa24ec8 0363-0958 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130614 ANDA ANDA091135 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 0363-0971_6bbe7bc7-d0c3-44b9-acb7-1601b728f1ea 0363-0971 HUMAN OTC DRUG childrens pain and fever Acetaminophen SUSPENSION ORAL 20100215 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL 0363-0974_85cc4b8c-03c3-4bda-8f9a-87bb446a6cae 0363-0974 HUMAN OTC DRUG Childrens Allergy cetirizine hydrochloride LIQUID ORAL 20080425 ANDA ANDA090254 Walgreen Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 0363-0980_fed9bd49-fd93-4521-a1dd-9ec4838cd217 0363-0980 HUMAN OTC DRUG pain relief Acetaminophen SUSPENSION/ DROPS ORAL 20110203 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 80 mg/.8mL 0363-0982_78447e47-b232-4e05-a86e-df6e7745463e 0363-0982 HUMAN OTC DRUG miconazole 3 miconazole nitrate KIT 20060906 ANDA ANDA076357 Walgreen Company 0363-0987_c651b20d-61e9-4704-9672-59b94c86033b 0363-0987 HUMAN OTC DRUG childrens wal tap dm Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20070309 OTC MONOGRAPH FINAL part341 Walgreen Company BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 0363-0990_2568c85a-82ae-43a1-aaca-3ccf35584a8b 0363-0990 HUMAN OTC DRUG Nighttime Cold and Flu Relief acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20080730 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 0363-0995_72cfd123-f863-4add-9d06-4966479926d1 0363-0995 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 19960125 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL 0363-0998_26888163-0316-4df8-a328-7432a3a6723e 0363-0998 HUMAN OTC DRUG Hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 19960104 OTC MONOGRAPH FINAL part346 Walgreen Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 0363-1000_e75e083d-9717-4526-3422-879826ba8182 0363-1000 HUMAN OTC DRUG Daytime Cold and Flu Relief Non Drowsy acetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20121009 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 0363-1003_e75e083d-9717-4526-3422-879826ba8182 0363-1003 HUMAN OTC DRUG Daytime Cold and Flu Relief Non Drowsy acetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20121009 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 0363-1005_51d36d60-6c52-2493-c162-d911d20315d3 0363-1005 HUMAN OTC DRUG nighttime cold and flu relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20121009 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 0363-1007_5afcf90a-12b5-41ad-82a8-c42a31eed46d 0363-1007 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090925 OTC MONOGRAPH FINAL part333 Walgreens ISOPROPYL ALCOHOL 70 mL/100mL 0363-1009_5092d638-6e53-e811-dad4-6060b56cdc93 0363-1009 HUMAN OTC DRUG Day Time Night Time Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130301 OTC MONOGRAPH FINAL part341 Walgreens Company 0363-1014_806e8484-c235-47bf-9c1d-da2e6b599ad7 0363-1014 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090925 OTC MONOGRAPH NOT FINAL part356 Walgreens HYDROGEN PEROXIDE 2.65 mL/100mL 0363-1019_1742b16e-bdfa-1bb2-eb50-d82f2b18e793 0363-1019 HUMAN OTC DRUG Day Time Night Time Sinus Relief Acetaminophen, Doxylamine succinate, Phenylephrine HCl KIT 20130301 OTC MONOGRAPH FINAL part341 Walgeens Company 0363-1024_95dd4d0c-496c-954b-5958-7052e6737afd 0363-1024 HUMAN OTC DRUG Wal-Zyr Wal-Zyr TABLET ORAL 20140902 ANDA ANDA078317 Walgreen Company CETIRIZINE HYDROCHLORIDE 10 mg/1 0363-1100_52a738c3-384a-4094-a302-9228797f1226 0363-1100 HUMAN OTC DRUG Walgreens Daytime Wal-Flu Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20130515 OTC MONOGRAPH FINAL part341 Walgreen Co. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 0363-1101_b7591ef5-145f-4e63-842b-cf27c212ce74 0363-1101 HUMAN OTC DRUG Walgreens night time wal-flu severe cold and cough honey lemon flavor infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20131008 OTC MONOGRAPH FINAL part341 Walgreen Co. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 0363-1102_edcb3093-57d6-459d-b996-19d64a647365 0363-1102 HUMAN OTC DRUG Walgreens Daytime Nighttime Wal-Flu Severe Cold and Cough Kit Acetaminophen, Diphenhydramine HCL, Phenylephrine HCL and Dextromethorphan HBr KIT 20140618 OTC MONOGRAPH FINAL part341 Walgreen Co. 0363-1105_681633f6-0f68-4247-8cb9-f374a5bbb776 0363-1105 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20140531 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC 500 [USP&apos'U]/g 0363-1108_54f74179-bdbe-4241-97b0-877774679c34 0363-1108 HUMAN OTC DRUG Milk of Magnesia Mint MAGNESIUM HYDROXIDE SUSPENSION ORAL 20100204 OTC MONOGRAPH FINAL part334 Walgreens MAGNESIUM HYDROXIDE 1200 mg/15mL 0363-1252_63a1a0ad-4d9f-4014-903e-ed4e9d4bedd7 0363-1252 HUMAN OTC DRUG Infants Dye-Free Ibuprofen Ibuprofen SUSPENSION ORAL 20100524 ANDA ANDA079058 Walgreen Company IBUPROFEN 50 mg/1.25mL 0363-1255_667d9cbb-0e2d-4593-8ced-0fe22842cacc 0363-1255 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20100524 ANDA ANDA074916 Walgreen Company IBUPROFEN 100 mg/5mL 0363-1261_667d9cbb-0e2d-4593-8ced-0fe22842cacc 0363-1261 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20100524 ANDA ANDA074916 Walgreen Company IBUPROFEN 100 mg/5mL 0363-1262_667d9cbb-0e2d-4593-8ced-0fe22842cacc 0363-1262 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20100524 ANDA ANDA074916 Walgreen Company IBUPROFEN 100 mg/5mL 0363-1263_667d9cbb-0e2d-4593-8ced-0fe22842cacc 0363-1263 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20100524 ANDA ANDA074916 Walgreen Company IBUPROFEN 100 mg/5mL 0363-1298_db076afc-674e-472e-ac49-bce5115e9b0b 0363-1298 HUMAN OTC DRUG WALGREENS TOLNAFTATE TOLNAFTATE CREAM TOPICAL 20110504 OTC MONOGRAPH FINAL part333C WALGREEN COMPANY TOLNAFTATE 10 mg/g 0363-1299_203b6279-f8d7-40a2-a379-1567a16324d9 0363-1299 HUMAN OTC DRUG WALGREENS CLOTRIMAZOLE CLOTRIMAZOLE CREAM TOPICAL 20110414 OTC MONOGRAPH FINAL part333C WALGREEN CO CLOTRIMAZOLE 1 g/100g 0363-1303_d60da067-761d-48b8-a6bd-b4a0e7bd68bc 0363-1303 HUMAN OTC DRUG Magnesium Citrate Magnesium Citrate LIQUID ORAL 20090402 OTC MONOGRAPH NOT FINAL part334 Walgreens MAGNESIUM CITRATE 2.65 mL/100mL 0363-1352_b2d7647b-d610-4d37-9e20-0051e56d0d46 0363-1352 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070910 ANDA ANDA078547 Walgreen Company NICOTINE 2 mg/1 0363-1411_0ccf179f-e9a0-4f45-809b-bcd8dd955efa 0363-1411 HUMAN OTC DRUG WALGREENS ANTI ITCH DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part336 WALGREEN COMPANY DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1; .1 g/100g; g/100g 0363-1465_48a1b268-700f-4955-90ba-d639248e801c 0363-1465 HUMAN OTC DRUG WALGREENS MAXIMUM REDNESS RELIEF GLYCERIN, NAPHAZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20141125 OTC MONOGRAPH FINAL part349 WALGREEN COMPANY GLYCERIN; NAPHAZOLINE HYDROCHLORIDE .0025; .00012 mg/mL; mg/mL 0363-1466_e0d7e2eb-b6f2-428d-965c-619363770ac3 0363-1466 HUMAN OTC DRUG WALGREENS LUBRICANT EYE CARBOXYMETHYLCELLULOSE SODIUM SOLUTION OPHTHALMIC 20120930 OTC MONOGRAPH FINAL part349 WALGREEN COMPANY CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL 0363-1597_80b218f7-66bb-4e15-a0dc-ec9b6af1b056 0363-1597 HUMAN OTC DRUG Severe Cold and Flu acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140908 OTC MONOGRAPH FINAL part341 Walgreen Company 0363-1600_5c501fda-7e6e-4690-881e-1e6d35164999 0363-1600 HUMAN OTC DRUG Senna S docusate sodium and sennosides TABLET ORAL 20130330 OTC MONOGRAPH NOT FINAL part334 Walgreens DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 0363-1640_d810c500-6d96-4201-8997-79bf8f307d31 0363-1640 HUMAN OTC DRUG Sore Throat Cherry Chloraseptic LIQUID ORAL 20120201 OTC MONOGRAPH NOT FINAL part356 Walgreens PHENOL 1.5 g/100mL 0363-1650_8358a518-b264-4846-a514-0f8828cf0810 0363-1650 HUMAN OTC DRUG Oral Relief Phenol SPRAY ORAL 20120201 OTC MONOGRAPH NOT FINAL part356 Walgreens PHENOL 1.4 g/100mL 0363-1676_4de572e9-1bc5-42d7-8490-aaf1992c8f3a 0363-1676 HUMAN OTC DRUG Walgreens Sterile Original Eye Drops Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20131002 OTC MONOGRAPH FINAL part349 Walgreens Company TETRAHYDROZOLINE HYDROCHLORIDE .05 mg/10mg 0363-1677_9452d82d-433a-4f1d-8b97-b76ddc84b1aa 0363-1677 HUMAN OTC DRUG Walgreens Sterile Advance Relief Eye Drops Dextran, Polyethylene Glycol, Povidone, Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20141125 OTC MONOGRAPH FINAL part349 Walgreen Company DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .001; .01; .01; .0005 mg/mg; mg/mg; mg/mg; mg/mg 0363-1678_2c376932-8f5d-4a7c-975f-e8df27c83423 0363-1678 HUMAN OTC DRUG Walgreens Artificial Tears Lubricant Eye Drops Dextran 70, Hypromellose 2910 SOLUTION/ DROPS OPHTHALMIC 20131002 OTC MONOGRAPH FINAL part349 Walgreens Company DEXTRAN 70; HYPROMELLOSES .001; .003 mg/mg; mg/mg 0363-1701_142759ab-fbe0-4ea4-a9a7-a9ad66ead224 0363-1701 HUMAN OTC DRUG Walgreens Artificial Tears Lubricant Eye Drops Dextran 70, Hypromellose 2910 SOLUTION/ DROPS OPHTHALMIC 20131002 OTC MONOGRAPH FINAL part349 Walgreens Company DEXTRAN 70; HYPROMELLOSES .001; .003 mg/mg; mg/mg 0363-2004_82b5e839-9e31-4051-8ec7-213ee367af9c 0363-2004 HUMAN OTC DRUG Flu Relief Therapy Acetaminophen, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20090806 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL 0363-2008_e9831cf9-73cb-475e-9a06-dc6c6b0eb5ce 0363-2008 HUMAN OTC DRUG Ology Fluoride Sodium Monofluorophosphate PASTE DENTAL 20130321 OTC MONOGRAPH FINAL part355 Walgreens SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 0363-2009_fd70a054-9555-477d-8a62-ab61a65dc86b 0363-2009 HUMAN OTC DRUG Walgreens Sensitive Dura-namel Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20130118 OTC MONOGRAPH NOT FINAL part356 Walgreens POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 0363-2013_77b7d0ec-6698-40af-a247-5e5709f14eea 0363-2013 HUMAN OTC DRUG studio 35 beauty Clinical Strength Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120601 OTC MONOGRAPH FINAL part350 WALGREEN COMPANY ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g 0363-2014_306c7b87-35d0-40b6-a292-6a6604155f25 0363-2014 HUMAN OTC DRUG studio 35 beauty Clinical Strength Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120610 OTC MONOGRAPH FINAL part350 WALGREEN COMPANY ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g 0363-2016_e0f1960a-65e0-4b84-bac6-6497453090a0 0363-2016 HUMAN OTC DRUG Walgreens Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 0363-2062_5a804fa0-55dc-44df-a087-9e208f73acbc 0363-2062 HUMAN OTC DRUG Walgreens Clotrimazole 3 Clotrimazole CREAM VAGINAL 20000412 NDA NDA021143 Walgreen Company CLOTRIMAZOLE 2 g/100g 0363-2063_37c6bc47-8c43-4389-8738-7604cf2e0990 0363-2063 HUMAN OTC DRUG Walgreens Hydrocortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Walgreen Company HYDROCORTISONE 1 g/100g 0363-2075_0a506bf7-143e-4b59-a5f1-b6d9f7e62ae2 0363-2075 HUMAN OTC DRUG Walgreens Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC 500 [USP'U]/g 0363-2083_f3b4f3fb-1cd4-4589-bb3f-c72b57e5ab8a 0363-2083 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Walgreen Company TERBINAFINE HYDROCHLORIDE 1 g/100g 0363-2085_baec871b-0e97-42ca-88c7-83220512f588 0363-2085 HUMAN OTC DRUG Wal-itin Allergy Relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Walgreen Company LORATADINE 5 mg/5mL 0363-2088_a63774ea-cae4-4c0f-b6d3-9824139359ec 0363-2088 HUMAN OTC DRUG Wal-Zyr Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Walgreen Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 0363-2092_a342cb25-d6e8-43ec-846f-a91c7fae3f99 0363-2092 HUMAN OTC DRUG Childrens Wal-itin Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Walgreen Company LORATADINE 5 mg/5mL 0363-2102_60629fea-af6e-4dc1-8681-7e5683b944cd 0363-2102 HUMAN OTC DRUG Wal-Zyr Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Walgreen Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 0363-2104_cf1b3bb3-2762-4170-80f4-3e2c06389a2e 0363-2104 HUMAN OTC DRUG Flu Relief Therapy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20090806 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 0363-2106_1e8ecd9d-ca6c-40aa-9864-b9deb6eb2e9f 0363-2106 HUMAN OTC DRUG Wal-Zyr All Day Allergy Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 WALGREEN COMPANY CETIRIZINE HYDROCHLORIDE 5 mg/5mL 0363-2109_6cf099cc-ebff-439f-9735-8b7bca42b180 0363-2109 HUMAN OTC DRUG Walgreens Jock Itch Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Walgreen Company CLOTRIMAZOLE 10 mg/g 0363-2172_80d2aa68-1ac5-4e65-ae29-755e3c0088dc 0363-2172 HUMAN OTC DRUG Patch Walgreens Menthol PATCH TOPICAL 20140808 OTC MONOGRAPH NOT FINAL part348 Walgreens MENTHOL 5 g/1001 0363-2177_a1e67d9e-e1a2-45de-bc3b-712b3f82ea2d 0363-2177 HUMAN OTC DRUG EXTRA STRENGTH WAL-DRYL ITCH RELIEF DIPHENHYDRAMINE, ZINC ACETATE SPRAY TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part348 WALGREEN CO DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 mL/100mL; mL/100mL 0363-2181_60da1ec7-4249-4858-b192-f871504306f7 0363-2181 HUMAN OTC DRUG Foaming Acne Face Wash Walgreens Benzoyl Peroxide 10% CREAM TOPICAL 20130215 OTC MONOGRAPH FINAL part333D Walgreens BENZOYL PEROXIDE 10 g/100g 0363-2242_889cb90f-a486-4760-881d-e517be63658a 0363-2242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH FINAL part347 Walgreens DIMETHICONE 125 mg/1 0363-2529_74ac83c5-db2e-485f-8fe4-0c29f94e1006 0363-2529 HUMAN OTC DRUG Bronchial Asthma Relief Ephedrine HCl, Guaifenesin TABLET ORAL 20020213 OTC MONOGRAPH FINAL part341 Walgreens Company EPHEDRINE HYDROCHLORIDE; GUAIFENESIN 12.5; 200 mg/1; mg/1 0363-2990_35dfa3d5-0286-44f0-a047-1f370b7b2781 0363-2990 HUMAN OTC DRUG Dye-Free Wal-Dryl Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20010913 OTC MONOGRAPH FINAL part336 WALGREEN CO. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0363-3000_0289a586-9ffe-424d-a8ce-75cf6ce2bad2 0363-3000 HUMAN OTC DRUG Wal-Sporin Bacitracin Zinc, Polymyxin B Sulfate OINTMENT TOPICAL 20061030 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g 0363-3063_deea44c1-6e4e-4d11-9e8d-e628e3a70702 0363-3063 HUMAN OTC DRUG Walgreens Corn Remover SALICYLIC ACID STRIP TOPICAL 20130601 OTC MONOGRAPH FINAL part358F WALGREENS Co SALICYLIC ACID 4.42 mg/1 0363-3187_70676bf3-5d2b-4f2b-b6a3-a46255d66817 0363-3187 HUMAN OTC DRUG ARTHRITIS RELIEF WELL AT WALGREENS Trolamine Salicylate 10% SPRAY TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part348 Walgreens TROLAMINE SALICYLATE 100 mg/mL 0363-3300_60c2a683-4cec-4304-b5eb-a1d0dff9dd22 0363-3300 HUMAN OTC DRUG WELL AT WALGREENS BABY ADVANCED HEALING PETROLATUM LOTION TOPICAL 20140806 OTC MONOGRAPH FINAL part346 WALGREEN COMPANY PETROLATUM .41 g/g 0363-3350_37e90904-2317-41b2-9412-d978afc2aca0 0363-3350 HUMAN OTC DRUG Mucus Relief Cold and Sinus Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL 0363-3360_e09f0832-a449-4800-9975-df5f1df6b10a 0363-3360 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL 0363-3380_934a2211-daf3-4c4a-a8d7-fcaf031a31e6 0363-3380 HUMAN OTC DRUG Mucus Relief DM Max Maximum Strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Walgreens DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL 0363-3420_c678008c-d1a0-4128-8742-4c3d5729a104 0363-3420 HUMAN OTC DRUG Maximum Strength Allergy Sinus Acetaminophen, Chlorpheniramine maleate, Pseudoephedrine HCl TABLET ORAL 19991001 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 500; 2; 30 mg/1; mg/1; mg/1 0363-3440_69e4a990-3642-4c8a-8484-87458747af1c 0363-3440 HUMAN OTC DRUG Awake Caffeine TABLET ORAL 19980414 OTC MONOGRAPH FINAL part340 WALGREEN CO. CAFFEINE 200 mg/1 0363-3450_9bc859cb-6a2b-4dd9-9340-b07143c11c81 0363-3450 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone OINTMENT TOPICAL 19900101 OTC MONOGRAPH NOT FINAL part348 Walgreen Company HYDROCORTISONE 1 g/100g 0363-3510_e7ea8ee9-0272-4e93-a450-e0feec500bf8 0363-3510 HUMAN OTC DRUG Jock Itch clotrimazole CREAM TOPICAL 20140615 OTC MONOGRAPH FINAL part333C Walgreen Company CLOTRIMAZOLE 1 g/100g 0363-3560_6abadab3-868b-43eb-968d-f0b2eea9ba10 0363-3560 HUMAN OTC DRUG OLOGY TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20130405 OTC MONOGRAPH FINAL part346 WALGREEN COMPANY TITANIUM DIOXIDE; ZINC OXIDE .0255; .03 g/g; g/g 0363-3701_16d34649-6a4b-40d0-a2e0-924fdd02ccb3 0363-3701 HUMAN OTC DRUG STUDIO 35 SPRING MORNING TRICLOSAN LIQUID TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part333E WALGREEN COMPANY TRICLOSAN 1.5 mg/mL 0363-3790_4f2093d8-6cff-4b76-8991-affe697d2402 0363-3790 HUMAN OTC DRUG Childrens Cold and Cough Nighttime Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Walgreens DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 0363-4000_a58a8ff3-1b5c-4c7e-8d94-1765d1d7fbd7 0363-4000 HUMAN OTC DRUG Walgreens Aloe Vera Burn Relief Pain Relieving LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part348 WALGREEN CO. LIDOCAINE HYDROCHLORIDE .5 g/100g 0363-4001_091e79d0-193a-45ca-9511-261bcaf91747 0363-4001 HUMAN OTC DRUG Walgreens Sunscreen SPF 15 OCTINOXATE OXYBENZONE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. OCTINOXATE; OXYBENZONE 7.5; 4.5 g/100g; g/100g 0363-4002_741b4923-11ec-407d-8142-6aafffa78062 0363-4002 HUMAN OTC DRUG Walgreens Aloe Vera Cooling MENTHOL GEL TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part348 WALGREEN CO. MENTHOL .1 g/100g 0363-4003_aac95c08-2eaf-4e50-afd6-c80eae677a96 0363-4003 HUMAN OTC DRUG Walgreens Aloe Vera Pain Relieving LIDOCAINE GEL TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part348 WALGREEN CO. LIDOCAINE; MENTHOL .5; .1 g/100g; g/100g 0363-4004_0b8329b9-858e-4641-94f5-6fd11f5960ce 0363-4004 HUMAN OTC DRUG Walgreens Dark Tanning Oil Sunscreen SPF 4 OCTINOXATE SPRAY TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. OCTINOXATE 3 g/100g 0363-4005_3494c44d-6001-408f-9bb0-308a35332b04 0363-4005 HUMAN OTC DRUG Walgreens Sunscreen Sport SPF 30 OCTINOXATE OXYBENZONE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g 0363-4006_696cda86-c6fd-44a7-8a08-bed5ef62c2c3 0363-4006 HUMAN OTC DRUG Walgreens Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g 0363-4007_e09f7f24-7036-4dc5-a97f-f3a8edf0fb90 0363-4007 HUMAN OTC DRUG Walgreens Sunscreen SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 0363-4008_ae78166e-77e9-4ada-b0b9-e0594f381e86 0363-4008 HUMAN OTC DRUG Walgreens SunscreenSPF 45 SPF 45 SPF 45 ZINC OXIDE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 7.5; 8; 6.86 g/100g; g/100g; g/100g 0363-4009_bcb9a966-3572-4bc2-be16-43fbab91bdf9 0363-4009 HUMAN OTC DRUG Walgreens SunscreenSPF 70 SPF 70 OCTOCRYLENE OXYBENZONE ZINC OXIDE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 2; 3.9 g/100g; g/100g; g/100g 0363-4010_30561192-5799-4c88-99b1-c521a36f9c76 0363-4010 HUMAN OTC DRUG Walgreens Sunscreen Baby SPF 50 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 0363-4011_90c559f2-e631-4748-a03e-fe67c1c55074 0363-4011 HUMAN OTC DRUG Walgreens Sunscreen Sport SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g 0363-4012_18354cb3-68f5-41d5-8a21-c8d7b48463cd 0363-4012 HUMAN OTC DRUG Walgreens PAIN RELIEVING LIDOCAINE MENTHOL GEL TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part348 WALGREEN CO. LIDOCAINE; MENTHOL .7; .2 g/100g; g/100g 0363-4013_15ef02f7-b372-49b5-8227-70059fa0f7ce 0363-4013 HUMAN OTC DRUG Walgreens sunscreen Broad Spectrum SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100g; g/100g; g/100g; g/100g 0363-4014_e58a0c7d-887a-4a2f-b3cd-a59ab469a1f9 0363-4014 HUMAN OTC DRUG Walgreens SUNSCREEN Clear Zinc Broad Spectrum SPF 50 OCTOCRYLENE, ZINC OXIDE LOTION TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. OCTOCRYLENE; ZINC OXIDE 4; 5 g/100g; g/100g 0363-4015_f698b299-fe2a-4ba4-9b16-344119596651 0363-4015 HUMAN OTC DRUG Walgreens SUNSCREEN Sport Broad Spectrum SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g 0363-4016_56f90bc8-bd11-42be-a9ec-c9ff576f20ed 0363-4016 HUMAN OTC DRUG Walgreens Sunscreen Broad Spectrum SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE LOTION TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g 0363-4050_ec08913e-718c-4f15-8156-fc7083421999 0363-4050 HUMAN OTC DRUG Cough Cold and Sore Throat Childrens Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL 0363-4115_29a32a2e-224e-4b00-8045-d1426bdce1ec 0363-4115 HUMAN OTC DRUG Walgreens Original Strength Anti Itch Diphenhydramine hydrochloride, zinc acetate CREAM TOPICAL 20130927 OTC MONOGRAPH NOT FINAL part348 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1; .1 g/100g; g/100g 0363-4190_74f306d4-2a71-48c9-ab98-378260507a9d 0363-4190 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20141105 ANDA ANDA090711 Walgreen Company NICOTINE 4 mg/1 0363-4193_0269211f-74a9-4eb2-8c7f-18aea94a9ca8 0363-4193 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 20141001 OTC MONOGRAPH NOT FINAL part334 Walgreen Company MAGNESIUM HYDROXIDE 1200 mg/15mL 0363-4208_f8185527-7398-4578-8ac6-e7433d146d13 0363-4208 HUMAN OTC DRUG Miconazole Nitrate Athletes Foot Liquid Spray SPRAY TOPICAL 20100518 OTC MONOGRAPH FINAL part333C Walgreens Company MICONAZOLE NITRATE 3 g/150g 0363-4218_cc79eb01-cb2c-48e9-8c88-f5abc5842b3e 0363-4218 HUMAN OTC DRUG Walgreens Clotrimazole Antifungal Clotrimazole CREAM TOPICAL 20141212 OTC MONOGRAPH FINAL part333C Walgreen Company CLOTRIMAZOLE 1 g/100g 0363-4246_8e5348a2-2289-4fb3-8073-c580c7a15236 0363-4246 HUMAN OTC DRUG studio35 Eczema Colloidal Oatmeal CREAM TOPICAL 20140901 OTC MONOGRAPH FINAL part347 Walgreen Company OATMEAL 1 g/100g 0363-4360_b3a5a1d0-4012-436c-8e0c-99bee5cd0229 0363-4360 HUMAN OTC DRUG Walgreens Calamine Skin Protectant FERRIC OXIDE RED, ZINC OXIDE LOTION TOPICAL 20111005 OTC MONOGRAPH FINAL part347 Walgreen Company FERRIC OXIDE RED; ZINC OXIDE 8; 8 mL/100mL; mL/100mL 0363-4429_580f8fef-cda6-4d3b-80a0-134d5a184b5c 0363-4429 HUMAN OTC DRUG Well Beginnings Baby Eczema Colloidal Oatmeal CREAM TOPICAL 20140415 OTC MONOGRAPH FINAL part347 Walgreen Company OATMEAL 1 g/100g 0363-4470_1051c2ff-cb4a-4976-910d-e1c446226d7e 0363-4470 HUMAN OTC DRUG Pain Reliever PM Extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20141230 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 0363-4490_48f4055f-a1d1-42e1-9d85-85053f94345b 0363-4490 HUMAN OTC DRUG Junior Fast-Dissolving Pain and Fever Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN 160 mg/1 0363-4660_ecc8efc3-4378-4a50-a49b-d289237787ff 0363-4660 HUMAN OTC DRUG Oil-Free Daily Face Salicylic Acid CREAM TOPICAL 20140915 OTC MONOGRAPH FINAL part333D Walgreen Company SALICYLIC ACID 2 g/100g 0363-4663_0ac33fd2-ed29-4500-80f3-91f2c47c7b4e 0363-4663 HUMAN OTC DRUG Salicylic Acid Wart Remover Gel Pen GEL TOPICAL 20140315 OTC MONOGRAPH FINAL part358B Walgreen Company SALICYLIC ACID .17 g/g 0363-4730_08354915-1013-4959-b733-bd5b47b2a92c 0363-4730 HUMAN OTC DRUG Nighttime Multi-Symptom Cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl CAPSULE ORAL 20050721 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 0363-4809_b00b5342-8656-41a4-bb12-db875c61a4ae 0363-4809 HUMAN OTC DRUG Walgreen Sterile Lubricant Drops 70 Count Carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20140325 OTC MONOGRAPH FINAL part349 Walgreen Company CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL 0363-4816_4c26c457-6011-480a-9cf5-0e853f805313 0363-4816 HUMAN OTC DRUG Walgreen Sterile Lubricant Drops 30 Count Carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20140325 OTC MONOGRAPH FINAL part349 Walgreen Company CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL 0363-5000_f421c24f-3677-45b2-8002-cb3beb21ab86 0363-5000 HUMAN OTC DRUG Chocolated Laxative Sennosides Stimulant Laxative TABLET, CHEWABLE ORAL 20140410 OTC MONOGRAPH NOT FINAL part334 Walgreens SENNOSIDES 15 mg/1 0363-5270_808832d2-f708-48ce-9b29-b5f4b0143ac2 0363-5270 HUMAN OTC DRUG Sinus Congestion and Pain Severe Daytime Aceetaminophen, Guaifenesin and Phenylephrine HCl TABLET ORAL 20050806 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 0363-5335_3d788650-2349-4193-9fdb-a428ba54acfc 0363-5335 HUMAN OTC DRUG Walgreens Severe Oral Pain Reliever Benzocaine LIQUID ORAL 20120110 OTC MONOGRAPH FINAL part333B Walgreens BENZOCAINE 20 g/100g 0363-5336_37c4bcb1-8d4c-43c1-a9b5-a5b4c6b94f92 0363-5336 HUMAN OTC DRUG Walgreens Severe Toothache Relief Benzocaine PASTE, DENTIFRICE TOPICAL 20130801 OTC MONOGRAPH FINAL part333B Walgreens BENZOCAINE 20 g/100g 0363-5337_6c7ce16e-31b2-4d49-b8e5-b63131462127 0363-5337 HUMAN OTC DRUG Walgreens Maximum Strength Benzocaine PASTE, DENTIFRICE TOPICAL 20130801 OTC MONOGRAPH FINAL part333B Walgreens BENZOCAINE 20 g/100g 0363-5345_5a8606c8-c137-40a8-b3d8-87a70c44f2fa 0363-5345 HUMAN OTC DRUG Infants Gas Relief Non-Staining Formula Dimethicone LIQUID ORAL 20130415 OTC MONOGRAPH FINAL part332 Walgreens DIMETHICONE 20 mg/.3mL 0363-5440_6934291f-9507-4d2b-a169-d6fefa234918 0363-5440 HUMAN OTC DRUG Wal-Phed PE Acetaminophen, Diphenhydramine HCl, Phenyelphrine HCl TABLET ORAL 20060919 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 0363-5460_7da1f0c6-f865-4be7-8ac3-66dd6207ebac 0363-5460 HUMAN OTC DRUG Wal-Phed PE Multi Symptom Acetaminophen, Dextromathorphan HBr, Gauifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20070222 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 0363-5523_395bde9d-043b-4736-a9c9-59864c9b596a 0363-5523 HUMAN OTC DRUG Salicylic Acid Ultra Thin Corn Removers PATCH TOPICAL 20130730 OTC MONOGRAPH FINAL part358F Walgreens Company SALICYLIC ACID 40 mg/91 0363-5773_e88ebb97-08d3-46d7-921c-9812a1a65360 0363-5773 HUMAN OTC DRUG Infants Gas Relief Non-Staining Formula DIMETHICONE LIQUID ORAL 20130615 OTC MONOGRAPH FINAL part332 Walgreens DIMETHICONE 20 mg/.3mL 0363-6040_9633b49b-9152-4bdb-9c2e-e6b39b92006a 0363-6040 HUMAN OTC DRUG Medicated Lip Balm Medicated Lip Balm SALVE TOPICAL 20131030 OTC MONOGRAPH NOT FINAL part348 Walgreen Co CAMPHOR (NATURAL); MENTHOL; PHENOL 1.7; .7; .4 mg/g; mg/g; mg/g 0363-6050_04cd52a1-fc2c-4f46-918c-2e907b099316 0363-6050 HUMAN OTC DRUG Lip Balm Sunscreen SPF 4 Original SPF4 Lip Balm STICK TOPICAL 20130901 OTC MONOGRAPH FINAL part352 Walgreen Co PADIMATE O 1.5 mg/g 0363-6060_1210cd47-4d41-4c70-9a9b-c8e195733041 0363-6060 HUMAN OTC DRUG Lip Balm Sunscreen SPF 4 Cherry Flavor SPF4 Cherry Lip Balm STICK TOPICAL 20130901 OTC MONOGRAPH FINAL part352 Walgreen Co PADIMATE O 1.5 mg/g 0363-6080_6a82dba6-f36e-448c-af67-e98bb33f6da8 0363-6080 HUMAN OTC DRUG Medicated Lip Balm Medicated Lip Balm Stick STICK TOPICAL 20131030 OTC MONOGRAPH NOT FINAL part348 Walgreen Co CAMPHOR (NATURAL); MENTHOL; PHENOL 1.7; .7; .4 mg/g; mg/g; mg/g 0363-6170_dba5de73-ef82-46d7-a203-b8dbeabb9b7e 0363-6170 HUMAN OTC DRUG Maximum Strength Mucus Relief Severe Congestion and Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 0363-6230_ed4d22c4-18a9-402c-a48a-5f00e590fbcb 0363-6230 HUMAN OTC DRUG Walgreens Baby Teething Benzocaine GEL, DENTIFRICE ORAL 20110120 OTC MONOGRAPH FINAL part333B Walgreens BENZOCAINE 7.5 g/100g 0363-6332_68c4cb46-8956-48b6-971c-37d9867914f1 0363-6332 HUMAN OTC DRUG Walgreens Baby Teething Benzocaine GEL, DENTIFRICE ORAL 20130901 OTC MONOGRAPH FINAL part333B Walgreens BENZOCAINE 7.5 g/100g 0363-6450_cde6d291-839c-48ba-87cd-b6ab650e0269 0363-6450 HUMAN OTC DRUG Aspirin Enteric Coated Low Dose Aspirin TABLET ORAL 20140725 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ASPIRIN 81 mg/1 0363-6711_92f51fe6-dc8b-499b-ad38-bd6d0347a169 0363-6711 HUMAN OTC DRUG Walgreen Vanishing Scent Muscle and Joint Menthol GEL TOPICAL 20140528 OTC MONOGRAPH NOT FINAL part348 Walgreen Company MENTHOL 2.5 g/100g 0363-6771_a287fc99-d3d1-4fd1-95d8-728a7ef02bcc 0363-6771 HUMAN OTC DRUG Walgreens Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20140528 OTC MONOGRAPH FINAL part347 Walgreen Company ZINC OXIDE 40 g/100g 0363-6880_05e37456-e923-4ad7-9609-0981435cb33d 0363-6880 HUMAN OTC DRUG Walgreens Pain Relieving for Boils Benzocaine OINTMENT TOPICAL 20140528 OTC MONOGRAPH FINAL part333B Walgreen Company BENZOCAINE 20 g/100g 0363-7110_90832dbe-f8d5-442e-bda3-24040ad22f38 0363-7110 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20130327 OTC MONOGRAPH NOT FINAL part333E Walgreen Co. BENZALKONIUM CHLORIDE 1.2478 g/L 0363-7123_376711a5-402a-4b7a-8107-25fb9657a26b 0363-7123 HUMAN OTC DRUG WalgreensTriple Antibiotic Bacitracin, Neomycin, Polymyxin B OINTMENT TOPICAL 20080701 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 0363-7128_d3de5465-34c3-4a7d-997d-77611e49751c 0363-7128 HUMAN OTC DRUG Walgreens First Aid Antiseptic Lidocaine Hydrochloride, Benzalkonium Chloride SPRAY TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part333A Walgreens BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .0013; .025 g/g; g/g 0363-7215_1e0b6871-f060-43ba-aa12-0313c31a39e1 0363-7215 HUMAN OTC DRUG STUDIO 35 AMBER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part333E WALGREEN COMPANY BENZALKONIUM CHLORIDE 1.3 mg/mL 0363-7220_df022a54-279e-4c8c-af91-3c54c7fba69d 0363-7220 HUMAN OTC DRUG Walgreens Lubricant Eye Drops Polyethylen Glycol and Propylene Gloycol SOLUTION/ DROPS OPHTHALMIC 20140806 OTC MONOGRAPH FINAL part349 Walgreen Company POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mg/100mg; mg/100mg 0363-7730_9b479b8a-fdfe-44d1-a561-8b4f368d19db 0363-7730 HUMAN OTC DRUG Salicylic Acid Extra Thick Callus Removers PATCH TOPICAL 20120816 OTC MONOGRAPH FINAL part358F Walgreen Company SALICYLIC ACID 40 mg/41 0363-7731_ae6498f9-f361-45bd-9ff5-a71d587d6d66 0363-7731 HUMAN OTC DRUG Undecylenic Acid Anti-Fungal Liquid LIQUID TOPICAL 20120816 OTC MONOGRAPH FINAL part333C Walgreen Company UNDECYLENIC ACID .25 g/g 0363-8042_a62d5df3-c050-468d-a463-adc540c878cf 0363-8042 HUMAN OTC DRUG Tolnaftate Athletes Foot Liquid SPRAY TOPICAL 20090311 OTC MONOGRAPH FINAL part333C Walgreens Company TOLNAFTATE 1.5 g/150g 0363-8127_8bea2fa1-ff9e-4522-9de0-48ecf0e0fa90 0363-8127 HUMAN OTC DRUG Walgreens Muscle Rub Ulra Strength Camphor, Menthol, Methyl salicylate CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part348 Walgreen Company CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g 0363-8130_5c786c79-1ba2-4c96-93ea-0e91437e9c73 0363-8130 HUMAN OTC DRUG Walgreens Maximum Strength Benzocaine PASTE, DENTIFRICE TOPICAL 20110120 OTC MONOGRAPH FINAL part333B walgreens BENZOCAINE 20 g/100g 0363-8190_e042ff45-6aa9-427c-8ab9-8fac3cff00ff 0363-8190 HUMAN OTC DRUG Walgreens Chap Aid Moisturizer octinoxate, oxybenzone, white petrolatum STICK TOPICAL 20101011 OTC MONOGRAPH FINAL part352 Walgreen Company OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 407 mg/g; mg/g; mg/g 0363-8201_81d0a950-23da-44da-ba25-d4164a2ca7bb 0363-8201 HUMAN OTC DRUG Walgreens Peroxide Whitening Fluoride PASTE, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part355 Walgreens SODIUM MONOFLUOROPHOSPHATE .76 g/100g 0363-8202_eae11f67-f862-4cf7-86f7-b41eb7160e06 0363-8202 HUMAN OTC DRUG Walgreens Radiant White Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Walgreens SODIUM FLUORIDE .243 g/100g 0363-8203_d325bc79-6215-4ccf-afb7-b3b1d6ae77ab 0363-8203 HUMAN OTC DRUG Walgreens Sulfate Free Fluoride PASTE, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part355 Walgreens SODIUM FLUORIDE .24 g/100g 0363-8204_a7f923e7-43a3-468a-a1e6-6f61c5d0d9b1 0363-8204 HUMAN OTC DRUG Walgreens Stain Care Fluoride PASTE, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part355 Walgreens SODIUM FLUORIDE .243 g/100g 0363-8217_f800def8-86e5-4eb9-bb3e-850cd05a2fa4 0363-8217 HUMAN OTC DRUG Salicylic Acid Liquid Wart Remover LIQUID TOPICAL 20080623 OTC MONOGRAPH FINAL part358F Walgreen Company SALICYLIC ACID .17 g/g 0363-8220_9375d732-216a-4f9b-ae4a-d08224194b6b 0363-8220 HUMAN OTC DRUG Childrens Double Antibiotic with Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20111121 OTC MONOGRAPH NOT FINAL part347 Walgreen Company NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 0363-8396_19d6e254-525a-443b-bf28-e05a7323e1f6 0363-8396 HUMAN OTC DRUG Eye Lubricant polyethylene glycol, propylene glycol LIQUID OPHTHALMIC 20121205 OTC MONOGRAPH FINAL part349 Walgreen Company POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/10mL; mg/10mL 0363-8410_1a59428d-127c-4625-af48-69f8314bdb1b 0363-8410 HUMAN OTC DRUG Studio35 Extra Strength Medicated Body Dimethicone and Menthol LOTION TOPICAL 20140901 OTC MONOGRAPH FINAL part347 Walgreen Company DIMETHICONE; MENTHOL 5; .5 g/100mL; g/100mL 0363-8480_8a1ed5c5-3fb6-4d01-aa35-b40fa52a4b87 0363-8480 HUMAN OTC DRUG Chest Rub camphor, eucalyptus oil, menthol LOTION TOPICAL 20140716 OTC MONOGRAPH FINAL part341 Walgreens Company CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/42.5g; kg/42.5g; kg/42.5g 0363-8588_0950cfaa-a517-4d64-a67f-74cdfbb8cc5a 0363-8588 HUMAN OTC DRUG Calamine Plus Pramoxine HCl Calamine Plus No-Touch AEROSOL, SPRAY TOPICAL 20130312 OTC MONOGRAPH NOT FINAL part348 Walgreens Company FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE .345; 2.72; 24.16 mg/177mL; mg/177mL; mg/177mL 0363-9020_e516a156-209d-4f69-8ebc-9a53e8d98f20 0363-9020 HUMAN OTC DRUG Homeopathic Ear Pain Relief Chamomilla and Mercurius solubilis and Sulphur SOLUTION AURICULAR (OTIC) 20071201 UNAPPROVED HOMEOPATHIC Walgreen Co CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR 10; 15; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 0363-9021_828dd539-9ef9-4bce-9a5d-c67cf686d4df 0363-9021 HUMAN OTC DRUG Ear Ease Chamomile and Mercurius Solubilis and Sulphur SOLUTION AURICULAR (OTIC) 20121214 UNAPPROVED HOMEOPATHIC Walgreen Company CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR 10; 15; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 0363-9030_c0aaf0e0-1df7-480a-835e-3ba9f4146222 0363-9030 HUMAN OTC DRUG Pink Eye Remedy Belladonna and Euphrasia and Hepar sulphuris SOLUTION/ DROPS OPHTHALMIC 20071201 UNAPPROVED HOMEOPATHIC Walgreen Co ATROPA BELLADONNA; CALCIUM SULFIDE; EUPHRASIA STRICTA 6; 12; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 0363-9031_7571e1f3-981a-4141-ba71-261f4bed6fa2 0363-9031 HUMAN OTC DRUG Irritated Eye Atropa Belladonna and Calcium Sulfide and Euphrasia Stricta SOLUTION/ DROPS OPHTHALMIC 20121214 UNAPPROVED HOMEOPATHIC Walgreen Company ATROPA BELLADONNA; CALCIUM SULFIDE; EUPHRASIA STRICTA 6; 12; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 0363-9040_ffa01602-5332-4685-bb93-14edb40a84c5 0363-9040 HUMAN OTC DRUG Sodium Chloride Sodium Chloride SOLUTION/ DROPS OPHTHALMIC 20130212 OTC MONOGRAPH FINAL part349 Walgreens SODIUM CHLORIDE 50 mg/mL 0363-9050_6b786b80-9636-4732-81df-38eb7b56966d 0363-9050 HUMAN OTC DRUG Sodium Chloride Sodium Chloride OINTMENT OPHTHALMIC 20130212 OTC MONOGRAPH FINAL part349 Walgreens SODIUM CHLORIDE 50 mg/g 0363-9060_1c533cbe-1e24-42d7-9572-0e8d31481a75 0363-9060 HUMAN OTC DRUG Ketotifen Fumarate Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20130125 ANDA ANDA077958 Walgreens KETOTIFEN FUMARATE .25 mg/mL 0363-9113_dff99bd0-c214-40a3-81c2-7d1817c9003a 0363-9113 HUMAN OTC DRUG Walgreens Capsaicin Hot Capsaicin Extract PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Walgreen Co CAPSAICIN .6 mg/1 0363-9160_9b3a6dda-2af0-411e-84fa-fddb0246585e 0363-9160 HUMAN OTC DRUG Maximum Strength Diaper Rash Zinc Oxide CREAM TOPICAL 20140501 OTC MONOGRAPH FINAL part347 Walgreen Company ZINC OXIDE 40 g/100g 0363-9170_ad1bccff-35aa-4c09-b497-fb4f8e9c7def 0363-9170 HUMAN OTC DRUG NICOTINE nicotine polacrilex LOZENGE ORAL 20110714 NDA NDA021330 Walgreens NICOTINE 2 mg/1 0363-9171_ad1bccff-35aa-4c09-b497-fb4f8e9c7def 0363-9171 HUMAN OTC DRUG NICOTINE nicotine polacrilex LOZENGE ORAL 20110714 NDA NDA021330 Walgreens NICOTINE 4 mg/1 0363-9180_8c76b580-9e1c-4ea4-8198-c5b5677318a6 0363-9180 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20100215 NDA NDA020165 Walgreen Company NICOTINE 21 mg/24h 0363-9200_ad1bccff-35aa-4c09-b497-fb4f8e9c7def 0363-9200 HUMAN OTC DRUG NICOTINE nicotine polacrilex LOZENGE ORAL 20110714 NDA NDA021330 Walgreens NICOTINE 4 mg/1 0363-9320_ab82e32f-647d-44c3-bc89-ee24cfc877af 0363-9320 HUMAN OTC DRUG WALGREENS INSTANT HAND SANITIZER ETHYL ALCOHOL SPRAY TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333E WALGREEN CO ALCOHOL 62 mL/100mL 0363-9362_151485de-cf01-408e-9869-d12833182129 0363-9362 HUMAN OTC DRUG Walgreens Wrinkle Repair Moisturizer SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20130105 OTC MONOGRAPH NOT FINAL part352 Walgreens Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 4; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL 0363-9529_ab93ed6b-1585-4997-b5cc-bc30036c86c2 0363-9529 HUMAN OTC DRUG Walgreens Anticavity and Antigingivitis Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20081124 OTC MONOGRAPH FINAL part355 Walgreen SODIUM FLUORIDE 2.43 mg/g 0363-9650_fa931256-b009-4c7b-a376-0dc95b7207bc 0363-9650 HUMAN OTC DRUG Naphazoline Hydrochloride and Pheniramine Maleate Naphazoline hydrochloride and Pheniramine Maleate SOLUTION/ DROPS OPHTHALMIC 20130423 ANDA ANDA202795 Walgreens NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .25; 3 mg/mL; mg/mL 0363-9688_ff32ace0-2999-435f-9fb6-0f12fbfaf3b6 0363-9688 HUMAN OTC DRUG Walgreens Anti-Sagging and Ultra Hydrating Day Broad Spectrum SPF15 Sunscreen Avobenzone, Oxybenzone, Octocrylene CREAM TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part352 Walgreen Company AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 10; 2 g/100g; g/100g; g/100g 0363-9757_a9ab0c4c-dd84-444b-9c0c-edc3eb464ab7 0363-9757 HUMAN OTC DRUG Salicylic Acid Corn Removers PATCH TOPICAL 20080722 OTC MONOGRAPH FINAL part358F Walgreen Company SALICYLIC ACID 40 mg/91 0363-9889_40360ff5-c4be-4596-ab66-2415975aeeeb 0363-9889 HUMAN OTC DRUG Salicylic Acid Liquid corn and Callus remover LIQUID TOPICAL 20080709 OTC MONOGRAPH FINAL part358F Walgreen Company SALICYLIC ACID .17 g/g 0372-0004_c863b9be-68be-404d-8a21-16237bbcf43e 0372-0004 HUMAN OTC DRUG Scot-Tussin Original SF Multi-Symptom Acetominophen, Phenylephrine Hydrochloride and Pheniramine Maleate LIQUID ORAL 19561201 OTC MONOGRAPH FINAL part341 SCOT-TUSSIN Pharmacal Co., Inc. ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 160; 4; 4 mg/5mL; mg/5mL; mg/5mL 0372-0006_a02a5ca8-8c0d-4be5-92b1-5271d555f252 0372-0006 HUMAN OTC DRUG Scot-Tussin Expectorant SF Cough Guaifenesin LIQUID ORAL 19740701 OTC MONOGRAPH FINAL part341 SCOT-TUSSIN Pharmacal Co., Inc. GUAIFENESIN 100 mg/5mL 0372-0036_88da39ce-b25d-4403-96e2-82277b4f01d7 0372-0036 HUMAN OTC DRUG Scot-Tussin DM SF Maximum Strength Cough Cold Dextromethorphan Hydrobromide Chlorpheniramine Maleate LIQUID ORAL 19830928 OTC MONOGRAPH FINAL part341 SCOT-TUSSIN Pharmacal Co., Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 2; 15 mg/5mL; mg/5mL 0372-0043_ba9ffd36-c22d-47c5-ab0a-954791e8ddd5 0372-0043 HUMAN OTC DRUG Scot-Tussin Diabetes Cough Formula with DM dextromethorphan hydrobromide LIQUID ORAL 19980318 OTC MONOGRAPH FINAL part341 SCOT-TUSSIN Pharmacal Co., Inc. DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL 0372-0050_29bdfa32-2dde-4ea0-a23a-6b68ed05d44f 0372-0050 HUMAN OTC DRUG Scot-Tussin Senior SF DMEXP Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 19991207 OTC MONOGRAPH FINAL part341 SCOT-TUSSIN Pharmacal Co., Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 15; 200 mg/5mL; mg/5mL 0374-5050_e3bff707-ef5e-4ce1-991c-3d59c6bb74de 0374-5050 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20100830 ANDA ANDA040879 Lyne Laboratories, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0374-5070_5bec8e6b-71af-41ff-8bc9-5df37534fbc2 0374-5070 HUMAN PRESCRIPTION DRUG CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric) CLINDAMYCIN PALMITATE HYDROCHLORIDE GRANULE, FOR SOLUTION ORAL 20120911 ANDA ANDA201821 Lyne Laboratories, Inc. CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0378-0001_014cd4ae-2b02-48d0-847a-a424e9a6b3db 0378-0001 HUMAN PRESCRIPTION DRUG Clorpres clonidine hydrochloride and chlorthalidone TABLET ORAL 20120507 ANDA ANDA071325 Mylan Pharmaceuticals Inc. CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE 15; .1 mg/1; mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0378-0014_605c980c-2897-4765-80dd-60c0fb0a64ff 0378-0014 HUMAN PRESCRIPTION DRUG Methotrexate methotrexate TABLET ORAL 19920518 ANDA ANDA081235 Mylan Pharmaceuticals Inc. METHOTREXATE 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0378-0018_a3f8b950-d8c5-4f43-ad27-10fcb8bcec38 0378-0018 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130422 ANDA ANDA076704 Mylan Pharmaceuticals Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0018_ffab7980-f813-41e4-bc84-b2521598423c 0378-0018 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20120502 ANDA ANDA076704 Mylan Pharmaceuticals Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0023_3981dd97-048a-41c5-b218-183c87ee1607 0378-0023 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20121204 ANDA ANDA072838 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-0027_014cd4ae-2b02-48d0-847a-a424e9a6b3db 0378-0027 HUMAN PRESCRIPTION DRUG Clorpres clonidine hydrochloride and chlorthalidone TABLET ORAL 20120507 ANDA ANDA071325 Mylan Pharmaceuticals Inc. CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE 15; .2 mg/1; mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0378-0028_af74832c-d5c4-4c96-ad1c-5f6c228f09ce 0378-0028 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 19931031 ANDA ANDA074172 Mylan Pharmaceuticals Inc. NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0030_0eb4b0da-2c8a-417c-accf-3fc6a0a4aaad 0378-0030 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium clorazepate dipotassium TABLET ORAL 19870717 ANDA ANDA071858 Mylan Pharmaceuticals Inc. CLORAZEPATE DIPOTASSIUM 3.75 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-0032_a3f8b950-d8c5-4f43-ad27-10fcb8bcec38 0378-0032 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130422 ANDA ANDA076704 Mylan Pharmaceuticals Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0032_ffab7980-f813-41e4-bc84-b2521598423c 0378-0032 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20120502 ANDA ANDA076704 Mylan Pharmaceuticals Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0040_0eb4b0da-2c8a-417c-accf-3fc6a0a4aaad 0378-0040 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium clorazepate dipotassium TABLET ORAL 19870717 ANDA ANDA071858 Mylan Pharmaceuticals Inc. CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-0042_3c380df0-a482-44aa-bbbf-51029c91f612 0378-0042 HUMAN PRESCRIPTION DRUG Perphenazine and Amitriptyline Hydrochloride perphenazine and amitriptyline hydrochloride TABLET, FILM COATED ORAL 19881110 ANDA ANDA071443 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 10; 4 mg/1; mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] 0378-0045_3981dd97-048a-41c5-b218-183c87ee1607 0378-0045 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20121204 ANDA ANDA072838 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-0047_a3f8b950-d8c5-4f43-ad27-10fcb8bcec38 0378-0047 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130422 ANDA ANDA076704 Mylan Pharmaceuticals Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0047_ffab7980-f813-41e4-bc84-b2521598423c 0378-0047 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20120502 ANDA ANDA076704 Mylan Pharmaceuticals Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0048_df6daa71-e68c-41a7-bff8-7dc3b0596701 0378-0048 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 ANDA ANDA076801 Mylan Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0378-0052_19846442-3844-49d3-9442-4282fed37a84 0378-0052 HUMAN PRESCRIPTION DRUG Pindolol pindolol TABLET ORAL 19920903 ANDA ANDA074019 Mylan Pharmaceuticals Inc. PINDOLOL 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0053_f45db833-cec2-45d8-8b5f-ca1e820b8f48 0378-0053 HUMAN PRESCRIPTION DRUG Cimetidine cimetidine TABLET, FILM COATED ORAL 19940517 ANDA ANDA074246 Mylan Pharmaceuticals Inc. CIMETIDINE 200 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0378-0055_cb884a5e-bc13-43d8-9b2f-f3ee50db896c 0378-0055 HUMAN PRESCRIPTION DRUG Timolol Maleate timolol maleate TABLET ORAL 19900608 ANDA ANDA072668 Mylan Pharmaceuticals Inc. TIMOLOL MALEATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0060_30d32a15-5731-4ffc-a69c-b4c76e312a76 0378-0060 HUMAN PRESCRIPTION DRUG Maprotiline Hydrochloride maprotiline hydrochloride TABLET, FILM COATED ORAL 19881003 ANDA ANDA072285 Mylan Pharmaceuticals Inc. MAPROTILINE HYDROCHLORIDE 25 mg/1 0378-0069_4250cbdf-0c7f-447c-9435-190a2c8c51e8 0378-0069 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 19970326 ANDA ANDA074461 Mylan Pharmaceuticals Inc. INDAPAMIDE 1.25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0378-0070_0eb4b0da-2c8a-417c-accf-3fc6a0a4aaad 0378-0070 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium clorazepate dipotassium TABLET ORAL 19870717 ANDA ANDA071858 Mylan Pharmaceuticals Inc. CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-0072_014cd4ae-2b02-48d0-847a-a424e9a6b3db 0378-0072 HUMAN PRESCRIPTION DRUG Clorpres clonidine hydrochloride and chlorthalidone TABLET ORAL 20120507 ANDA ANDA071325 Mylan Pharmaceuticals Inc. CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE 15; .3 mg/1; mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0378-0073_3c380df0-a482-44aa-bbbf-51029c91f612 0378-0073 HUMAN PRESCRIPTION DRUG Perphenazine and Amitriptyline Hydrochloride perphenazine and amitriptyline hydrochloride TABLET, FILM COATED ORAL 19881110 ANDA ANDA071443 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 50; 4 mg/1; mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] 0378-0076_1ed0df93-76a2-4f79-bc38-bb09b75cafb0 0378-0076 HUMAN PRESCRIPTION DRUG Flurbiprofen flurbiprofen TABLET, FILM COATED ORAL 19940620 ANDA ANDA074358 Mylan Pharmaceuticals Inc. FLURBIPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-0078_56660a35-e86a-4eb1-bed4-9f7689182c67 0378-0078 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET ORAL 20110516 ANDA ANDA090324 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0378-0080_4250cbdf-0c7f-447c-9435-190a2c8c51e8 0378-0080 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 19960328 ANDA ANDA074461 Mylan Pharmaceuticals Inc. INDAPAMIDE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0378-0081_3f830175-e2d8-410d-b25a-49e4cc3c97e4 0378-0081 HUMAN PRESCRIPTION DRUG Captopril and Hydrochlorothiazide captopril and hydrochlorothiazide TABLET ORAL 19971229 ANDA ANDA074896 Mylan Phamaceuticals Inc. CAPTOPRIL; HYDROCHLOROTHIAZIDE 25; 15 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0378-0083_3f830175-e2d8-410d-b25a-49e4cc3c97e4 0378-0083 HUMAN PRESCRIPTION DRUG Captopril and Hydrochlorothiazide captopril and hydrochlorothiazide TABLET ORAL 19971229 ANDA ANDA074896 Mylan Phamaceuticals Inc. CAPTOPRIL; HYDROCHLOROTHIAZIDE 25; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0084_3f830175-e2d8-410d-b25a-49e4cc3c97e4 0378-0084 HUMAN PRESCRIPTION DRUG Captopril and Hydrochlorothiazide captopril and hydrochlorothiazide TABLET ORAL 19971229 ANDA ANDA074896 Mylan Phamaceuticals Inc. CAPTOPRIL; HYDROCHLOROTHIAZIDE 50; 15 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0085_56660a35-e86a-4eb1-bed4-9f7689182c67 0378-0085 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET ORAL 20110516 ANDA ANDA090324 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0378-0086_3f830175-e2d8-410d-b25a-49e4cc3c97e4 0378-0086 HUMAN PRESCRIPTION DRUG Captopril and Hydrochlorothiazide captopril and hydrochlorothiazide TABLET ORAL 19971229 ANDA ANDA074896 Mylan Phamaceuticals Inc. CAPTOPRIL; HYDROCHLOROTHIAZIDE 50; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0087_30d32a15-5731-4ffc-a69c-b4c76e312a76 0378-0087 HUMAN PRESCRIPTION DRUG Maprotiline Hydrochloride maprotiline hydrochloride TABLET, FILM COATED ORAL 19881003 ANDA ANDA072285 Mylan Pharmaceuticals Inc. MAPROTILINE HYDROCHLORIDE 50 mg/1 0378-0088_e5d31abe-2f73-4b5b-8c22-d6e0eea7f6c8 0378-0088 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, EXTENDED RELEASE ORAL 20000426 ANDA ANDA075091 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0378-0092_30d32a15-5731-4ffc-a69c-b4c76e312a76 0378-0092 HUMAN PRESCRIPTION DRUG Maprotiline Hydrochloride maprotiline hydrochloride TABLET, FILM COATED ORAL 19881003 ANDA ANDA072285 Mylan Pharmaceuticals Inc. MAPROTILINE HYDROCHLORIDE 75 mg/1 0378-0093_1ed0df93-76a2-4f79-bc38-bb09b75cafb0 0378-0093 HUMAN PRESCRIPTION DRUG Flurbiprofen flurbiprofen TABLET, FILM COATED ORAL 19940620 ANDA ANDA074358 Mylan Pharmaceuticals Inc. FLURBIPROFEN 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-0094_e5d31abe-2f73-4b5b-8c22-d6e0eea7f6c8 0378-0094 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, EXTENDED RELEASE ORAL 19991006 ANDA ANDA075091 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0378-0127_19846442-3844-49d3-9442-4282fed37a84 0378-0127 HUMAN PRESCRIPTION DRUG Pindolol pindolol TABLET ORAL 19920903 ANDA ANDA074019 Mylan Pharmaceuticals Inc. PINDOLOL 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0130_fce8735c-aec4-49bb-b047-2ebc8ff2d753 0378-0130 HUMAN PRESCRIPTION DRUG Propoxyphene Hydrochloride and Acetaminophen propoxyphene hydrochloride and acetaminophen TABLET, FILM COATED ORAL 20091130 ANDA ANDA083978 Mylan Pharmaceuticals Inc. ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE 650; 65 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 0378-0135_3981dd97-048a-41c5-b218-183c87ee1607 0378-0135 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20121204 ANDA ANDA072838 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-0137_bc1ef0b4-9ca2-414b-9984-7c033fd54e09 0378-0137 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 19861024 ANDA ANDA018659 Mylan Pharmaceuticals Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 0378-0141_25869be1-c481-4e3a-9fee-1505c41b39d1 0378-0141 HUMAN PRESCRIPTION DRUG Spironolactone and Hydrochlorothiazide spironolactone and hydrochlorothiazide TABLET ORAL 20120904 ANDA ANDA086513 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 25; 25 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0143_f49baf56-9d2b-4873-9d61-104e08e8c152 0378-0143 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 19840420 NDA NDA018858 Mylan Pharmaceuticals Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-0144_2378410a-1b92-4e4c-af3f-f8f75fa70aaf 0378-0144 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20030220 ANDA ANDA074732 Mylan Pharmaceuticals Inc. TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 0378-0145_b6157f41-db7d-4ca6-b8bb-88c32b0e3da5 0378-0145 HUMAN PRESCRIPTION DRUG doxycycline hyclate doxycycline CAPSULE ORAL 19820329 ANDA ANDA062337 Mylan Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 50 mg/1 0378-0147_f49baf56-9d2b-4873-9d61-104e08e8c152 0378-0147 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 19840420 ANDA ANDA070624 Mylan Pharmaceuticals Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-0148_b6157f41-db7d-4ca6-b8bb-88c32b0e3da5 0378-0148 HUMAN PRESCRIPTION DRUG doxycycline hyclate doxycycline CAPSULE ORAL 19820329 ANDA ANDA062337 Mylan Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 100 mg/1 0378-0150_41f85c2b-59e8-4afd-9e0c-e14692d5c727 0378-0150 HUMAN PRESCRIPTION DRUG Chlorothiazide chlorothiazide TABLET ORAL 19750626 ANDA ANDA084217 Mylan Pharmaceuticals Inc. CHLOROTHIAZIDE 250 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0152_6ef686c6-a01a-4040-b658-851c3ebccc9e 0378-0152 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 19870609 ANDA ANDA070317 Mylan Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0378-0156_f7f0c289-9fed-40e8-b9ca-d1281b1123d6 0378-0156 HUMAN PRESCRIPTION DRUG Probenecid probenecid TABLET, FILM COATED ORAL 19760113 ANDA ANDA084211 Mylan Pharmaceuticals Inc. PROBENECID 500 mg/1 0378-0160_47d25166-6e14-416f-89e0-0c53e9b45a49 0378-0160 HUMAN PRESCRIPTION DRUG Methyclothiazide methyclothiazide TABLET ORAL 19820817 ANDA ANDA087672 Mylan Pharmaceuticals Inc. METHYCLOTHIAZIDE 5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0162_41f85c2b-59e8-4afd-9e0c-e14692d5c727 0378-0162 HUMAN PRESCRIPTION DRUG Chlorothiazide chlorothiazide TABLET ORAL 19750717 ANDA ANDA084217 Mylan Pharmaceuticals Inc. CHLOROTHIAZIDE 500 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0167_b6157f41-db7d-4ca6-b8bb-88c32b0e3da5 0378-0167 HUMAN PRESCRIPTION DRUG doxycycline hyclate doxycycline TABLET ORAL 19830215 ANDA ANDA062432 Mylan Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 100 mg/1 0378-0181_bc1ef0b4-9ca2-414b-9984-7c033fd54e09 0378-0181 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 19861024 ANDA ANDA018659 Mylan Pharmaceuticals Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 0378-0182_08b2638e-d91c-4e55-a83a-303abc533eb3 0378-0182 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 Mylan Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0183_08b2638e-d91c-4e55-a83a-303abc533eb3 0378-0183 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 Mylan Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0184_08b2638e-d91c-4e55-a83a-303abc533eb3 0378-0184 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 Mylan Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0185_08b2638e-d91c-4e55-a83a-303abc533eb3 0378-0185 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 Mylan Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0186_6ef686c6-a01a-4040-b658-851c3ebccc9e 0378-0186 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 19870609 ANDA ANDA070317 Mylan Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0378-0187_08b2638e-d91c-4e55-a83a-303abc533eb3 0378-0187 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 Mylan Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0197_1386c897-5231-4464-9f83-935f8ccc17b0 0378-0197 HUMAN PRESCRIPTION DRUG Chlorpropamide chlorpropamide TABLET ORAL 19840601 ANDA ANDA088549 Mylan Pharmaceuticals Inc. CHLORPROPAMIDE 100 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0378-0199_6ef686c6-a01a-4040-b658-851c3ebccc9e 0378-0199 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 19870609 ANDA ANDA070317 Mylan Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0378-0208_71eb4843-a366-4c7f-9fe9-9f7d63d13abe 0378-0208 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19810827 NDA NDA018487 Mylan Pharmaceuticals Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0378-0210_1386c897-5231-4464-9f83-935f8ccc17b0 0378-0210 HUMAN PRESCRIPTION DRUG Chlorpropamide chlorpropamide TABLET ORAL 19840601 ANDA ANDA088549 Mylan Pharmaceuticals Inc. CHLORPROPAMIDE 250 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0378-0211_02cc34f5-bd04-481c-86fb-5de01995733c 0378-0211 HUMAN PRESCRIPTION DRUG Chlordiazepoxide and Amitriptyline Hydrochloride chlordiazepoxide and amitriptyline hydrochloride TABLET, FILM COATED ORAL 19861210 ANDA ANDA071297 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE 12.5; 5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] CIV 0378-0213_e69d77a7-4979-4b8b-b968-a07d7a0d305e 0378-0213 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 19810226 ANDA ANDA086831 Mylan Pharmaceuticals Inc. CHLORTHALIDONE 50 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0378-0214_108f2d5f-8a99-4fe3-bd51-b7cedc4b2378 0378-0214 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19860610 ANDA ANDA070278 Mylan Pharmaceuticals Inc. HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] 0378-0215_5a786fe8-94d5-460a-9bd5-4d5271f9b2e0 0378-0215 HUMAN PRESCRIPTION DRUG Tolbutamide tolbutamide TABLET ORAL 19891101 ANDA ANDA086445 Mylan Pharmaceuticals Inc. TOLBUTAMIDE 500 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0378-0216_71eb4843-a366-4c7f-9fe9-9f7d63d13abe 0378-0216 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19870827 NDA NDA018487 Mylan Pharmaceuticals Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0378-0217_e55c3303-e629-490e-b2f7-650b99099e74 0378-0217 HUMAN PRESCRIPTION DRUG Tolazamide tolazamide TABLET ORAL 20130118 ANDA ANDA070259 Mylan Pharmaceuticals Inc. TOLAZAMIDE 250 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0378-0218_7ed0ad64-ba3e-427b-bcff-80374aa0cd0b 0378-0218 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20130218 ANDA ANDA073457 Mylan Pharmaceuticals Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0221_cb884a5e-bc13-43d8-9b2f-f3ee50db896c 0378-0221 HUMAN PRESCRIPTION DRUG Timolol Maleate timolol maleate TABLET ORAL 19900608 ANDA ANDA072668 Mylan Pharmaceuticals Inc. TIMOLOL MALEATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0222_e69d77a7-4979-4b8b-b968-a07d7a0d305e 0378-0222 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 19810226 ANDA ANDA086831 Mylan Pharmaceuticals Inc. CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0378-0228_df6daa71-e68c-41a7-bff8-7dc3b0596701 0378-0228 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 ANDA ANDA076801 Mylan Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0378-0231_7ed0ad64-ba3e-427b-bcff-80374aa0cd0b 0378-0231 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20130218 ANDA ANDA073457 Mylan Pharmaceuticals Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0232_71eb4843-a366-4c7f-9fe9-9f7d63d13abe 0378-0232 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19870827 ANDA ANDA070082 Mylan Pharmaceuticals Inc. FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0378-0243_58035cf5-f25a-4e9b-92ba-e4f8622822aa 0378-0243 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20020122 ANDA ANDA040424 Mylan Pharmaceuticals Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0378-0253_79b4b9da-70de-4efb-9eb0-e17db0f64c26 0378-0253 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 20100615 ANDA ANDA075211 Mylan Pharmaceuticals Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0378-0255_7439aed5-77bd-45d8-aaba-7ea4ea721b5e 0378-0255 HUMAN PRESCRIPTION DRUG Albuterol albuterol sulfate TABLET ORAL 19910117 ANDA ANDA072894 Mylan Pharmaceuticals Inc. ALBUTEROL SULFATE 2 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0378-0257_108f2d5f-8a99-4fe3-bd51-b7cedc4b2378 0378-0257 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19860610 ANDA ANDA070278 Mylan Pharmaceuticals Inc. HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] 0378-0261_be7f916c-1865-4b72-93ca-c97ec016e668 0378-0261 HUMAN PRESCRIPTION DRUG Ketoconazole ketoconazole TABLET ORAL 20000223 ANDA ANDA075597 Mylan Pharmaceuticals Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0378-0271_7a741982-0f59-498f-afc6-21af0b487b69 0378-0271 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 19850904 ANDA ANDA070325 Mylan Pharmaceuticals Inc. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-0274_2378410a-1b92-4e4c-af3f-f8f75fa70aaf 0378-0274 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20030220 ANDA ANDA074732 Mylan Pharmaceuticals Inc. TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 0378-0277_02cc34f5-bd04-481c-86fb-5de01995733c 0378-0277 HUMAN PRESCRIPTION DRUG Chlordiazepoxide and Amitriptyline Hydrochloride chlordiazepoxide and amitriptyline hydrochloride TABLET, FILM COATED ORAL 19861210 ANDA ANDA071297 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE 25; 10 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] CIV 0378-0302_79b4b9da-70de-4efb-9eb0-e17db0f64c26 0378-0302 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 20100615 ANDA ANDA075211 Mylan Pharmaceuticals Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0378-0313_f1d13e20-d413-412e-85d5-1384c69d4d6c 0378-0313 HUMAN PRESCRIPTION DRUG Tolmetin Sodium tolmetin sodium TABLET, FILM COATED ORAL 19940830 ANDA ANDA074473 Mylan Pharmaceuticals Inc. TOLMETIN SODIUM 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-0315_f3bdde60-60d7-4653-8fe3-c9c7c0af056d 0378-0315 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA076930 Mylan Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0378-0317_f45db833-cec2-45d8-8b5f-ca1e820b8f48 0378-0317 HUMAN PRESCRIPTION DRUG Cimetidine cimetidine TABLET, FILM COATED ORAL 19940517 ANDA ANDA074246 Mylan Pharmaceuticals Inc. CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0378-0318_df6daa71-e68c-41a7-bff8-7dc3b0596701 0378-0318 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 ANDA ANDA076801 Mylan Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0378-0327_108f2d5f-8a99-4fe3-bd51-b7cedc4b2378 0378-0327 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19860610 ANDA ANDA070278 Mylan Pharmaceuticals Inc. HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 0378-0330_3c380df0-a482-44aa-bbbf-51029c91f612 0378-0330 HUMAN PRESCRIPTION DRUG Perphenazine and Amitriptyline Hydrochloride perphenazine and amitriptyline hydrochloride TABLET, FILM COATED ORAL 19881110 ANDA ANDA071443 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 10; 2 mg/1; mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] 0378-0334_108f2d5f-8a99-4fe3-bd51-b7cedc4b2378 0378-0334 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20090717 ANDA ANDA070278 Mylan Pharmaceuticals Inc. HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] 0378-0335_108f2d5f-8a99-4fe3-bd51-b7cedc4b2378 0378-0335 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20090717 ANDA ANDA070278 Mylan Pharmaceuticals Inc. HALOPERIDOL 20 mg/1 Typical Antipsychotic [EPC] 0378-0344_f3bdde60-60d7-4653-8fe3-c9c7c0af056d 0378-0344 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA076930 Mylan Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0378-0345_7a741982-0f59-498f-afc6-21af0b487b69 0378-0345 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 19850904 ANDA ANDA070325 Mylan Pharmaceuticals Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-0347_8e5880ff-d0a4-4e86-9a05-bcf3d1a11b3d 0378-0347 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride and Hydrochlorothiazide propranolol hydrochloride and hydrochlorothiazide TABLET ORAL 20120906 ANDA ANDA070947 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE 25; 80 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0351_108f2d5f-8a99-4fe3-bd51-b7cedc4b2378 0378-0351 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19860610 ANDA ANDA070278 Mylan Pharmaceuticals Inc. HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] 0378-0353_04af70c5-dfe7-44f0-9037-5cc29ffe65ac 0378-0353 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA201071 Mylan Pharmaceuticals Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-0355_c4d86671-0cb9-4c59-9b0a-c34dd820e220 0378-0355 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020215 ANDA ANDA076152 Mylan Pharmaceuticals Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-0357_9d2cd44f-d766-44bc-9433-719afdfffe24 0378-0357 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970708 ANDA ANDA074425 Mylan Pharmaceuticals Inc. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 0378-0360_04af70c5-dfe7-44f0-9037-5cc29ffe65ac 0378-0360 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA201071 Mylan Pharmaceuticals Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-0372_f45db833-cec2-45d8-8b5f-ca1e820b8f48 0378-0372 HUMAN PRESCRIPTION DRUG Cimetidine cimetidine TABLET, FILM COATED ORAL 19940517 ANDA ANDA074246 Mylan Pharmaceuticals Inc. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0378-0373_e0eb3318-0e80-44c8-8399-747e7b943368 0378-0373 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ENTERAL 19980618 ANDA ANDA040274 Mylan Pharmaceuticals Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 0378-0390_04af70c5-dfe7-44f0-9037-5cc29ffe65ac 0378-0390 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA201071 Mylan Pharmaceuticals Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-0407_e318f4d1-f620-4924-b42d-4bd8ac2d1c93 0378-0407 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20130322 ANDA ANDA075889 Mylan Pharmaceuticals Inc. FLUVOXAMINE MALEATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-0412_e318f4d1-f620-4924-b42d-4bd8ac2d1c93 0378-0412 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20130322 ANDA ANDA075889 Mylan Pharmaceuticals Inc. FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-0414_e318f4d1-f620-4924-b42d-4bd8ac2d1c93 0378-0414 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20130322 ANDA ANDA075889 Mylan Pharmaceuticals Inc. FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-0415_48bb1660-5a04-44c5-b14f-1a44dfe087f2 0378-0415 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19771117 ANDA ANDA085762 Mylan Pharmaceuticals Inc. ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 0378-0421_7c1f226d-4a16-40bc-8b74-8335178d75e6 0378-0421 HUMAN PRESCRIPTION DRUG Methyldopa methyldopa TABLET ORAL 19850418 ANDA ANDA070076 Mylan Pharmaceuticals Inc. METHYLDOPA 500 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0378-0424_64b75ac9-6f61-43af-8f34-bc2d2e559707 0378-0424 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide metoprolol tartrate and hydrochlorothiazide TABLET ORAL 20040823 ANDA ANDA076792 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25; 50 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0427_1577129d-3723-4e8c-8fc1-a62fb7d146dc 0378-0427 HUMAN PRESCRIPTION DRUG Sulindac sulindac TABLET ORAL 19930622 ANDA ANDA073039 Mylan Pharmaceuticals Inc. SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-0433_e95b8141-ab38-4afa-b3f2-5cca67060da2 0378-0433 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20000511 ANDA ANDA075491 Mylan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0378-0434_64b75ac9-6f61-43af-8f34-bc2d2e559707 0378-0434 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide metoprolol tartrate and hydrochlorothiazide TABLET ORAL 20040823 ANDA ANDA076792 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25; 100 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0435_e95b8141-ab38-4afa-b3f2-5cca67060da2 0378-0435 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20000511 ANDA ANDA075491 Mylan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0378-0437_58035cf5-f25a-4e9b-92ba-e4f8622822aa 0378-0437 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20020122 ANDA ANDA040424 Mylan Pharmaceuticals Inc. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0378-0441_896c1d9d-f9c3-467a-b7fb-f4ad95ed427b 0378-0441 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20121203 ANDA ANDA076430 Mylan Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0378-0442_3c380df0-a482-44aa-bbbf-51029c91f612 0378-0442 HUMAN PRESCRIPTION DRUG Perphenazine and Amitriptyline Hydrochloride perphenazine and amitriptyline hydrochloride TABLET, FILM COATED ORAL 19881110 ANDA ANDA071443 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 25; 2 mg/1; mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] 0378-0443_896c1d9d-f9c3-467a-b7fb-f4ad95ed427b 0378-0443 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20121203 ANDA ANDA076430 Mylan Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0378-0444_896c1d9d-f9c3-467a-b7fb-f4ad95ed427b 0378-0444 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20121203 ANDA ANDA076430 Mylan Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0378-0445_64b75ac9-6f61-43af-8f34-bc2d2e559707 0378-0445 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide metoprolol tartrate and hydrochlorothiazide TABLET ORAL 20040823 ANDA ANDA076792 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 50; 100 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0447_896c1d9d-f9c3-467a-b7fb-f4ad95ed427b 0378-0447 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20121203 ANDA ANDA076430 Mylan Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0378-0460_0a3cee1b-82e9-4ef9-82bd-ee57f3f117cb 0378-0460 HUMAN PRESCRIPTION DRUG MAXZIDE maxzide TABLET ORAL 19880513 NDA NDA019129 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0464_0a3cee1b-82e9-4ef9-82bd-ee57f3f117cb 0378-0464 HUMAN PRESCRIPTION DRUG MAXZIDE-25 maxzide TABLET ORAL 19880513 NDA NDA019129 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0471_12cc1dcf-49b6-4316-a724-1d3f37f99e09 0378-0471 HUMAN PRESCRIPTION DRUG Fenoprofen Calcium Fenoprofen Calcium TABLET, FILM COATED ORAL 20091123 ANDA ANDA072267 Mylan Pharmaceuticals Inc. FENOPROFEN CALCIUM 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-0472_960c6aa9-a2c7-4ef6-941a-fdab81c73ffc 0378-0472 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090129 ANDA ANDA077567 Mylan Pharmaceuticals Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0378-0473_960c6aa9-a2c7-4ef6-941a-fdab81c73ffc 0378-0473 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090202 ANDA ANDA077567 Mylan Pharmaceuticals Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0378-0477_7a741982-0f59-498f-afc6-21af0b487b69 0378-0477 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 19850904 ANDA ANDA070325 Mylan Pharmaceuticals Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-0480_a5fa1894-00c1-4b60-8b3c-e6e1f7808326 0378-0480 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000314 ANDA ANDA090649 Mylan Pharmaceuticals Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-0481_a5fa1894-00c1-4b60-8b3c-e6e1f7808326 0378-0481 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000314 ANDA ANDA090649 Mylan Pharmaceuticals Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-0494_a5fa1894-00c1-4b60-8b3c-e6e1f7808326 0378-0494 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000314 ANDA ANDA090649 Mylan Pharmaceuticals Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-0501_479a485d-005f-407a-b1c9-5e865ea89280 0378-0501 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20000925 ANDA ANDA075768 Mylan Pharmaceuticals Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0503_479a485d-005f-407a-b1c9-5e865ea89280 0378-0503 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20000925 ANDA ANDA075768 Mylan Pharmaceuticals Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0505_479a485d-005f-407a-b1c9-5e865ea89280 0378-0505 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20000925 ANDA ANDA075768 Mylan Pharmaceuticals Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0507_939cd970-6d0d-4403-a7fa-21a2b87555df 0378-0507 HUMAN PRESCRIPTION DRUG Methyldopa and Hydrochlorothiazide methyldopa and hydrochlorothiazide TABLET ORAL 19860123 ANDA ANDA070265 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; METHYLDOPA 15; 250 mg/1; mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0512_f83bf6db-25ba-4aba-8f2e-7655e9fb8c93 0378-0512 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED ORAL 20120815 ANDA ANDA071483 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-0523_d81b7a6d-e70b-4f2b-b463-989fabe1ce3c 0378-0523 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate bisoprolol fumarate TABLET, FILM COATED ORAL 20120924 ANDA ANDA075831 Mylan Pharmaceuticals Inc. BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0524_d81b7a6d-e70b-4f2b-b463-989fabe1ce3c 0378-0524 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate bisoprolol fumarate TABLET, FILM COATED ORAL 20120924 ANDA ANDA075831 Mylan Pharmaceuticals Inc. BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0525_3981dd97-048a-41c5-b218-183c87ee1607 0378-0525 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20121204 ANDA ANDA072838 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-0531_1577129d-3723-4e8c-8fc1-a62fb7d146dc 0378-0531 HUMAN PRESCRIPTION DRUG Sulindac sulindac TABLET ORAL 19930622 ANDA ANDA073039 Mylan Pharmaceuticals Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-0541_f45db833-cec2-45d8-8b5f-ca1e820b8f48 0378-0541 HUMAN PRESCRIPTION DRUG Cimetidine cimetidine TABLET, FILM COATED ORAL 19940517 ANDA ANDA074246 Mylan Pharmaceuticals Inc. CIMETIDINE 800 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0378-0542_d36e265c-9fff-4957-87d7-00e4e87f0910 0378-0542 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20070226 ANDA ANDA077093 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0543_d36e265c-9fff-4957-87d7-00e4e87f0910 0378-0543 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20070226 ANDA ANDA077093 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0544_d36e265c-9fff-4957-87d7-00e4e87f0910 0378-0544 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20070226 ANDA ANDA077093 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0551_e55c3303-e629-490e-b2f7-650b99099e74 0378-0551 HUMAN PRESCRIPTION DRUG Tolazamide tolazamide TABLET ORAL 20130118 ANDA ANDA070259 Mylan Pharmaceuticals Inc. TOLAZAMIDE 500 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0378-0552_2be986a1-9980-4c70-b70b-bae6c2bf0519 0378-0552 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20121004 ANDA ANDA079187 Mylan Pharmaceuticals Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-0553_2be986a1-9980-4c70-b70b-bae6c2bf0519 0378-0553 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20121004 ANDA ANDA079187 Mylan Pharmaceuticals Inc. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-0554_2be986a1-9980-4c70-b70b-bae6c2bf0519 0378-0554 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20121004 ANDA ANDA079187 Mylan Pharmaceuticals Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-0557_2be986a1-9980-4c70-b70b-bae6c2bf0519 0378-0557 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20121004 ANDA ANDA079187 Mylan Pharmaceuticals Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-0572_7439aed5-77bd-45d8-aaba-7ea4ea721b5e 0378-0572 HUMAN PRESCRIPTION DRUG Albuterol albuterol sulfate TABLET ORAL 19910117 ANDA ANDA072894 Mylan Pharmaceuticals Inc. ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0378-0574_3c380df0-a482-44aa-bbbf-51029c91f612 0378-0574 HUMAN PRESCRIPTION DRUG Perphenazine and Amitriptyline Hydrochloride perphenazine and amitriptyline hydrochloride TABLET, FILM COATED ORAL 19881110 ANDA ANDA071443 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 25; 4 mg/1; mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] 0378-0577_bc568ed8-6312-4d66-9ea5-80ca9424343e 0378-0577 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride and Hydrochlorothiazide amiloride hydrochloride and hydrochlorothiazide TABLET ORAL 19911031 ANDA ANDA073209 Mylan Pharmaceuticals Inc. AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0611_7c1f226d-4a16-40bc-8b74-8335178d75e6 0378-0611 HUMAN PRESCRIPTION DRUG Methyldopa methyldopa TABLET ORAL 19850418 ANDA ANDA070076 Mylan Pharmaceuticals Inc. METHYLDOPA 250 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0378-0612_0e9d1322-e030-4a75-8935-0cb0befbb08c 0378-0612 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 19830315 ANDA ANDA088004 Mylan Pharmaceuticals Inc. THIORIDAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0378-0614_0e9d1322-e030-4a75-8935-0cb0befbb08c 0378-0614 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 19830315 ANDA ANDA088004 Mylan Pharmaceuticals Inc. THIORIDAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0378-0616_0e9d1322-e030-4a75-8935-0cb0befbb08c 0378-0616 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 19830315 ANDA ANDA088004 Mylan Pharmaceuticals Inc. THIORIDAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0378-0618_0e9d1322-e030-4a75-8935-0cb0befbb08c 0378-0618 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 19831118 ANDA ANDA088004 Mylan Pharmaceuticals Inc. THIORIDAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0378-0711_939cd970-6d0d-4403-a7fa-21a2b87555df 0378-0711 HUMAN PRESCRIPTION DRUG Methyldopa and Hydrochlorothiazide methyldopa and hydrochlorothiazide TABLET ORAL 19860123 ANDA ANDA070265 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; METHYLDOPA 25; 250 mg/1; mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0712_4127ab09-d8ab-4c9f-9b9a-62bb08b4e27e 0378-0712 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide enalapril maleate and hydrochlorothiazide TABLET ORAL 20121009 ANDA ANDA075624 Mylan Pharmaceuticals Inc. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 5; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0715_cb884a5e-bc13-43d8-9b2f-f3ee50db896c 0378-0715 HUMAN PRESCRIPTION DRUG Timolol Maleate timolol maleate TABLET ORAL 19900608 ANDA ANDA072668 Mylan Pharmaceuticals Inc. TIMOLOL MALEATE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0722_2f1b89a2-dd6f-4fc5-8b04-8584881f190e 0378-0722 HUMAN PRESCRIPTION DRUG Tizanidine tizanidine TABLET ORAL 20030506 ANDA ANDA076354 Mylan Pharmaceuticals Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0378-0723_4127ab09-d8ab-4c9f-9b9a-62bb08b4e27e 0378-0723 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide enalapril maleate and hydrochlorothiazide TABLET ORAL 20121009 ANDA ANDA075624 Mylan Pharmaceuticals Inc. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0724_2f1b89a2-dd6f-4fc5-8b04-8584881f190e 0378-0724 HUMAN PRESCRIPTION DRUG Tizanidine tizanidine TABLET ORAL 20030506 ANDA ANDA076354 Mylan Pharmaceuticals Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0378-0731_8e5880ff-d0a4-4e86-9a05-bcf3d1a11b3d 0378-0731 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride and Hydrochlorothiazide propranolol hydrochloride and hydrochlorothiazide TABLET ORAL 20120906 ANDA ANDA070947 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE 25; 40 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0734_c6371dbd-7b22-4ef7-b9a1-badc8ba20cc3 0378-0734 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine TABLET, FILM COATED ORAL 20131223 ANDA ANDA075755 Mylan Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-0735_c6371dbd-7b22-4ef7-b9a1-badc8ba20cc3 0378-0735 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine TABLET, FILM COATED ORAL 20131223 ANDA ANDA075755 Mylan Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-0751_24b22be4-dee4-4f86-9958-ebb37ed0cc08 0378-0751 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 19910530 ANDA ANDA073144 Mylan Pharmaceuticals Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0378-0757_7ed0ad64-ba3e-427b-bcff-80374aa0cd0b 0378-0757 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20130218 ANDA ANDA073457 Mylan Pharmaceuticals Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-0761_24b22be4-dee4-4f86-9958-ebb37ed0cc08 0378-0761 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20130424 ANDA ANDA073144 Mylan Pharmaceuticals Inc. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0378-0771_24b22be4-dee4-4f86-9958-ebb37ed0cc08 0378-0771 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20060203 ANDA ANDA073144 Mylan Pharmaceuticals Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0378-0772_f83bf6db-25ba-4aba-8f2e-7655e9fb8c93 0378-0772 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED ORAL 20120815 ANDA ANDA071483 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-0781_a79a5060-6ba0-4d8a-8a27-70cd2c151f86 0378-0781 HUMAN OTC DRUG Fexofenadine Hydrochloride fexofenadine TABLET, FILM COATED ORAL 20110825 ANDA ANDA077081 Mylan Pharmaceuticals Inc. FEXOFENADINE HYDROCHLORIDE 60 mg/1 0378-0782_a79a5060-6ba0-4d8a-8a27-70cd2c151f86 0378-0782 HUMAN OTC DRUG Fexofenadine Hydrochloride fexofenadine TABLET, FILM COATED ORAL 20110825 ANDA ANDA077081 Mylan Pharmaceuticals Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 0378-0810_35a303b5-470a-4c4c-a181-68e8518e5315 0378-0810 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20120807 ANDA ANDA075640 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-0825_cdd7e923-58eb-4ef4-9a28-9365c1e141ce 0378-0825 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 19990708 ANDA ANDA075417 Mylan Pharmaceuticals Inc. CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] 0378-0860_cdd7e923-58eb-4ef4-9a28-9365c1e141ce 0378-0860 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 19990708 ANDA ANDA075417 Mylan Pharmaceuticals Inc. CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] 0378-0871_017e8de4-474d-42cb-b8ef-a6b1577ae995 0378-0871 HUMAN PRESCRIPTION DRUG Clonidine clonidine PATCH TRANSDERMAL 20130208 ANDA ANDA076166 Mylan Pharmaceuticals Inc. CLONIDINE .1 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0378-0872_017e8de4-474d-42cb-b8ef-a6b1577ae995 0378-0872 HUMAN PRESCRIPTION DRUG Clonidine clonidine PATCH TRANSDERMAL 20130208 ANDA ANDA076166 Mylan Pharmaceuticals Inc. CLONIDINE .2 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0378-0873_017e8de4-474d-42cb-b8ef-a6b1577ae995 0378-0873 HUMAN PRESCRIPTION DRUG Clonidine clonidine PATCH TRANSDERMAL 20130208 ANDA ANDA076166 Mylan Pharmaceuticals Inc. CLONIDINE .3 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0378-0972_cdd7e923-58eb-4ef4-9a28-9365c1e141ce 0378-0972 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 20100420 ANDA ANDA075417 Mylan Pharmaceuticals Inc. CLOZAPINE 50 mg/1 Atypical Antipsychotic [EPC] 0378-0973_cdd7e923-58eb-4ef4-9a28-9365c1e141ce 0378-0973 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 20100420 ANDA ANDA075417 Mylan Pharmaceuticals Inc. CLOZAPINE 200 mg/1 Atypical Antipsychotic [EPC] 0378-1001_942272de-0dad-4718-bdce-b745dff16e9e 0378-1001 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 19870623 ANDA ANDA071093 Mylan Pharmaceuticals Inc. THIOTHIXENE 1 mg/1 Typical Antipsychotic [EPC] 0378-1005_17e7b974-8b98-46a1-87dd-f442164bb584 0378-1005 HUMAN PRESCRIPTION DRUG Azathioprine azathioprine TABLET ORAL 20091228 ANDA ANDA075568 Mylan Pharmaceuticals Inc. AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 0378-1012_40b716ad-a304-492e-8979-2ffe9456d165 0378-1012 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA076113 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-1020_82026df8-13a2-4638-902b-0650a48af124 0378-1020 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride nicardipine hydrochloride CAPSULE ORAL 19960719 ANDA ANDA074642 Mylan Pharmaceuticals Inc. NICARDIPINE HYDROCHLORIDE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-1043_a3a915dc-99cc-4de0-ad72-7f995f2a81c6 0378-1043 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20090406 ANDA ANDA090062 Mylan Pharmaceutical Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0378-1044_a3a915dc-99cc-4de0-ad72-7f995f2a81c6 0378-1044 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20090406 ANDA ANDA090062 Mylan Pharmaceutical Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0378-1045_a3a915dc-99cc-4de0-ad72-7f995f2a81c6 0378-1045 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20090406 ANDA ANDA090062 Mylan Pharmaceutical Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0378-1049_c9372e19-ac62-4066-93a5-b648b614c633 0378-1049 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Mylan Pharmaceuticals Inc. DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0378-1051_75f71737-b105-492f-90e2-f45ac0078863 0378-1051 HUMAN PRESCRIPTION DRUG Enalapril Maleate enalapril maleate TABLET ORAL 20000822 ANDA ANDA075480 Mylan Pharmaceuticals Inc. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0378-1052_75f71737-b105-492f-90e2-f45ac0078863 0378-1052 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000822 ANDA ANDA075480 Mylan Pharmaceuticals Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0378-1053_75f71737-b105-492f-90e2-f45ac0078863 0378-1053 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000822 ANDA ANDA075480 Mylan Pharmaceuticals Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0378-1054_75f71737-b105-492f-90e2-f45ac0078863 0378-1054 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000822 ANDA ANDA075480 Mylan Pharmaceuticals Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0378-1066_0adbd8e7-f4ef-43e5-87ad-4a825a89090c 0378-1066 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077923 Mylan Pharmaceuticals Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-1075_ca60a4d5-ace7-4889-94ee-e2265fd63811 0378-1075 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine telmisartan and amlodipine TABLET ORAL 20140919 ANDA ANDA202516 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; TELMISARTAN 5; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-1076_ca60a4d5-ace7-4889-94ee-e2265fd63811 0378-1076 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine telmisartan and amlodipine TABLET ORAL 20140919 ANDA ANDA202516 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; TELMISARTAN 10; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-1077_ca60a4d5-ace7-4889-94ee-e2265fd63811 0378-1077 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine telmisartan and amlodipine TABLET ORAL 20140919 ANDA ANDA202516 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; TELMISARTAN 5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-1078_ca60a4d5-ace7-4889-94ee-e2265fd63811 0378-1078 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine telmisartan and amlodipine TABLET ORAL 20140919 ANDA ANDA202516 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; TELMISARTAN 10; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-1089_0adbd8e7-f4ef-43e5-87ad-4a825a89090c 0378-1089 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077923 Mylan Pharmaceuticals Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-1101_c4992e8d-2a2d-4ea1-a9e7-36afbd6d217e 0378-1101 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 19890228 ANDA ANDA072575 Mylan Pharmaceuticals Inc. PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0378-1105_6d0cfff6-76b9-4c1d-a87f-b7c9101a09bf 0378-1105 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 19940510 ANDA ANDA074226 Mylan Pharmaceuticals Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0378-1110_6d0cfff6-76b9-4c1d-a87f-b7c9101a09bf 0378-1110 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 19940510 ANDA ANDA074226 Mylan Pharmaceuticals Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0378-1113_5872b60b-ab2a-4290-9695-b67660dc7fc6 0378-1113 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19980209 ANDA ANDA074792 Mylan Pharmaceuticals Inc. GLYBURIDE 1.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0378-1125_5872b60b-ab2a-4290-9695-b67660dc7fc6 0378-1125 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19980209 ANDA ANDA074792 Mylan Pharmaceuticals Inc. GLYBURIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0378-1132_af74832c-d5c4-4c96-ad1c-5f6c228f09ce 0378-1132 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 19931031 ANDA ANDA074172 Mylan Pharmaceuticals Inc. NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-1133_56660a35-e86a-4eb1-bed4-9f7689182c67 0378-1133 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET ORAL 20110516 ANDA ANDA090324 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0378-1134_d9a83438-56ec-4e5d-b8e4-262b029d3eb4 0378-1134 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20130516 ANDA ANDA074761 Mylan Pharmaceuticals Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-1140_f439ff49-bcc0-48ca-a9a9-aa91c9cd8070 0378-1140 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20020321 ANDA ANDA076008 Mylan Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 0378-1142_5872b60b-ab2a-4290-9695-b67660dc7fc6 0378-1142 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19990917 ANDA ANDA074792 Mylan Pharmaceuticals Inc. GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0378-1145_f439ff49-bcc0-48ca-a9a9-aa91c9cd8070 0378-1145 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20130731 ANDA ANDA076008 Mylan Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 7.5 mg/1 0378-1150_f439ff49-bcc0-48ca-a9a9-aa91c9cd8070 0378-1150 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20020321 ANDA ANDA076008 Mylan Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 0378-1160_067a5732-0d42-4570-b9e5-633ca001b42d 0378-1160 HUMAN PRESCRIPTION DRUG Guanfacine guanfacine Hydrochloride TABLET ORAL 19970128 ANDA ANDA074796 Mylan Pharmaceuticals Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0378-1165_f439ff49-bcc0-48ca-a9a9-aa91c9cd8070 0378-1165 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA076008 Mylan Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 0378-1171_af74832c-d5c4-4c96-ad1c-5f6c228f09ce 0378-1171 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 19931031 ANDA ANDA074172 Mylan Pharmaceuticals Inc. NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-1175_f439ff49-bcc0-48ca-a9a9-aa91c9cd8070 0378-1175 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20010801 ANDA ANDA076008 Mylan Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 30 mg/1 0378-1190_067a5732-0d42-4570-b9e5-633ca001b42d 0378-1190 HUMAN PRESCRIPTION DRUG Guanfacine guanfacine Hydrochloride TABLET ORAL 19970128 ANDA ANDA074796 Mylan Pharmaceuticals Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0378-1200_a419d720-1686-40ba-bb56-a823aa9caa3a 0378-1200 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride acebutolol hydrochloride CAPSULE ORAL 19950424 ANDA ANDA074288 Mylan Pharmaceuticals Inc. ACEBUTOLOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-1300_c5dd3758-260e-40ea-80ac-6346cd9f66a8 0378-1300 HUMAN PRESCRIPTION DRUG Lithium Carbonate lithium carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120725 ANDA ANDA202288 Mylan Pharmaceuticals Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 0378-1352_9248811e-e924-4f58-a8e7-6ded25b104cb 0378-1352 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19960916 NDA NDA019129 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-1355_9248811e-e924-4f58-a8e7-6ded25b104cb 0378-1355 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19960916 NDA NDA019129 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-1400_a419d720-1686-40ba-bb56-a823aa9caa3a 0378-1400 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride acebutolol hydrochloride CAPSULE ORAL 19950424 ANDA ANDA074288 Mylan Pharmaceuticals Inc. ACEBUTOLOL HYDROCHLORIDE 400 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-1403_3c0dacc0-3366-42a5-904b-eae8629d17a5 0378-1403 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET ORAL 20121231 ANDA ANDA201993 Mylan Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0378-1404_3c0dacc0-3366-42a5-904b-eae8629d17a5 0378-1404 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET ORAL 20121231 ANDA ANDA201993 Mylan Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0378-1411_183fb627-a66a-46c8-82f4-feba02c2c6f1 0378-1411 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960325 ANDA ANDA074587 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-1418_586313fd-37cb-4a5c-a562-941c73ef70c0 0378-1418 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 20121005 ANDA ANDA091652 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-1419_586313fd-37cb-4a5c-a562-941c73ef70c0 0378-1419 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 20121005 ANDA ANDA091652 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0378-1420_586313fd-37cb-4a5c-a562-941c73ef70c0 0378-1420 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 20121005 ANDA ANDA091652 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-1430_82026df8-13a2-4638-902b-0650a48af124 0378-1430 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride nicardipine hydrochloride CAPSULE ORAL 19960719 ANDA ANDA074642 Mylan Pharmaceuticals Inc. NICARDIPINE HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-1450_cbbd0244-c9b7-4262-aa38-bab969fb4c60 0378-1450 HUMAN PRESCRIPTION DRUG Lithium Carbonate lithium carbonate TABLET, EXTENDED RELEASE ORAL 20120809 ANDA ANDA202219 Mylan Pharmaceuticals Inc. LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] 0378-1452_018c3985-a739-461a-8850-5bea218f2cde 0378-1452 HUMAN PRESCRIPTION DRUG Estradiol estradiol TABLET ORAL 19990617 ANDA ANDA040326 Mylan Pharmaceuticals Inc. ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0378-1454_018c3985-a739-461a-8850-5bea218f2cde 0378-1454 HUMAN PRESCRIPTION DRUG Estradiol estradiol TABLET ORAL 19990617 ANDA ANDA040326 Mylan Pharmaceuticals Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0378-1458_018c3985-a739-461a-8850-5bea218f2cde 0378-1458 HUMAN PRESCRIPTION DRUG Estradiol estradiol TABLET ORAL 19990617 ANDA ANDA040326 Mylan Pharmaceuticals Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0378-1550_ca9b76b2-840e-4bd6-a9d1-f1a7850093e3 0378-1550 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride and Metformin Hydrochloride pioglitazone hydrochloride and metformin hydrochloride TABLET, FILM COATED ORAL 20120817 ANDA ANDA090406 Mylan Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0378-1560_c51aff7d-50d9-47d1-845f-d031c5a72e30 0378-1560 HUMAN PRESCRIPTION DRUG Phenytoin Sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 19990105 ANDA ANDA040298 Mylan Pharmaceuticals Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-1570_0e2b01c4-15cf-45f4-a2d3-f348646e3a2a 0378-1570 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous terazosin hydrochloride anhydrous CAPSULE ORAL 20000222 ANDA ANDA075140 Mylan Pharmaceuticals Inc. TERAZOSIN HYDROCHLORIDE ANHYDROUS 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0378-1575_ca9b76b2-840e-4bd6-a9d1-f1a7850093e3 0378-1575 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride and Metformin Hydrochloride pioglitazone hydrochloride and metformin hydrochloride TABLET, FILM COATED ORAL 20120817 ANDA ANDA090406 Mylan Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0378-1610_82976d90-6219-488c-9e81-e12d4aaa4afd 0378-1610 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride CAPSULE ORAL 20130327 ANDA ANDA040319 Mylan Pharmaceuticals Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0378-1620_82976d90-6219-488c-9e81-e12d4aaa4afd 0378-1620 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride TABLET ORAL 20130327 ANDA ANDA040317 Mylan Pharmaceuticals Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0378-1626_ccb15b4a-87b9-4c4f-8703-7026864384a2 0378-1626 HUMAN PRESCRIPTION DRUG Voriconazole voriconazole TABLET, FILM COATED ORAL 20110215 ANDA ANDA090547 Mylan Pharmaceuticals Inc. VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0378-1640_ccb15b4a-87b9-4c4f-8703-7026864384a2 0378-1640 HUMAN PRESCRIPTION DRUG Voriconazole voriconazole TABLET, FILM COATED ORAL 20110215 ANDA ANDA090547 Mylan Pharmaceuticals Inc. VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0378-1650_815a9bdb-9a40-42bb-bc39-b44f20880747 0378-1650 HUMAN PRESCRIPTION DRUG Nitrofurantoin (macrocrystals) nitrofurantoin (macrocrystals) CAPSULE ORAL 19970909 ANDA ANDA074967 Mylan Pharmaceuticals Inc. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 0378-1657_b4b88748-89a8-46ff-b00d-8ac5e4cb414f 0378-1657 HUMAN PRESCRIPTION DRUG Sildenafil sildinafil TABLET, FILM COATED ORAL 20121109 ANDA ANDA201150 Mylan Pharmaceuticals Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0378-1665_efd81c6c-189b-40a3-9a3b-be50843759e4 0378-1665 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride tizanidine hydrochloride CAPSULE ORAL 20130301 ANDA ANDA091502 Mylan Pharmaceuticals Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0378-1666_efd81c6c-189b-40a3-9a3b-be50843759e4 0378-1666 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride tizanidine hydrochloride CAPSULE ORAL 20130301 ANDA ANDA091502 Mylan Pharmaceuticals Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0378-1667_efd81c6c-189b-40a3-9a3b-be50843759e4 0378-1667 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride tizanidine hydrochloride CAPSULE ORAL 20130301 ANDA ANDA091502 Mylan Pharmaceuticals Inc. TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0378-1700_815a9bdb-9a40-42bb-bc39-b44f20880747 0378-1700 HUMAN PRESCRIPTION DRUG Nitrofurantoin (macrocrystals) nitrofurantoin (macrocrystals) CAPSULE ORAL 20040921 ANDA ANDA077025 Mylan Pharmaceuticals Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 0378-1704_284b0f10-edd6-441a-b253-6d576ebaab53 0378-1704 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride pramipexole dihydrochloride TABLET ORAL 20101104 ANDA ANDA077854 Mylan Pharmaceuticals Inc. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-1705_284b0f10-edd6-441a-b253-6d576ebaab53 0378-1705 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride pramipexole dihydrochloride TABLET ORAL 20101104 ANDA ANDA077854 Mylan Pharmaceuticals Inc. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-1707_284b0f10-edd6-441a-b253-6d576ebaab53 0378-1707 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride pramipexole dihydrochloride TABLET ORAL 20101104 ANDA ANDA077854 Mylan Pharmaceuticals Inc. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-1711_284b0f10-edd6-441a-b253-6d576ebaab53 0378-1711 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride pramipexole dihydrochloride TABLET ORAL 20101104 ANDA ANDA077854 Mylan Pharmaceuticals Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-1712_284b0f10-edd6-441a-b253-6d576ebaab53 0378-1712 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride pramipexole dihydrochloride TABLET ORAL 20101104 ANDA ANDA077854 Mylan Pharmaceuticals Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-1713_284b0f10-edd6-441a-b253-6d576ebaab53 0378-1713 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride pramipexole dihydrochloride TABLET ORAL 20101104 ANDA ANDA090764 Mylan Pharmaceuticals Inc. PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-1743_79dae996-aa1a-4487-93c0-ec310fa98534 0378-1743 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070322 ANDA ANDA078183 Mylan Pharmaceuticals Inc. CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 212.6; 287.5 mg/1; mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0378-1745_79dae996-aa1a-4487-93c0-ec310fa98534 0378-1745 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070322 ANDA ANDA078183 Mylan Pharmaceuticals Inc. CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 425.2; 574.9 mg/1; mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0378-1800_4a6b4f8b-3cb6-4afe-9615-c6a34c1f2fae 0378-1800 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0378-1803_4a6b4f8b-3cb6-4afe-9615-c6a34c1f2fae 0378-1803 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0378-1805_4a6b4f8b-3cb6-4afe-9615-c6a34c1f2fae 0378-1805 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0378-1807_4a6b4f8b-3cb6-4afe-9615-c6a34c1f2fae 0378-1807 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0378-1809_4a6b4f8b-3cb6-4afe-9615-c6a34c1f2fae 0378-1809 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0378-1811_4a6b4f8b-3cb6-4afe-9615-c6a34c1f2fae 0378-1811 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0378-1813_4a6b4f8b-3cb6-4afe-9615-c6a34c1f2fae 0378-1813 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0378-1815_4a6b4f8b-3cb6-4afe-9615-c6a34c1f2fae 0378-1815 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0378-1817_4a6b4f8b-3cb6-4afe-9615-c6a34c1f2fae 0378-1817 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0378-1819_4a6b4f8b-3cb6-4afe-9615-c6a34c1f2fae 0378-1819 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0378-1821_4a6b4f8b-3cb6-4afe-9615-c6a34c1f2fae 0378-1821 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 300 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0378-1823_4a6b4f8b-3cb6-4afe-9615-c6a34c1f2fae 0378-1823 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20061215 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0378-1901_96d49709-65a5-4aba-b0c6-003de3a20ef1 0378-1901 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20030911 ANDA ANDA076577 Mylan Pharmaceuticals Inc. MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0378-1902_96d49709-65a5-4aba-b0c6-003de3a20ef1 0378-1902 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20030911 ANDA ANDA076577 Mylan Pharmaceuticals Inc. MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0378-1903_96d49709-65a5-4aba-b0c6-003de3a20ef1 0378-1903 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20030911 ANDA ANDA076577 Mylan Pharmaceuticals Inc. MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0378-1910_5b4d24e7-a6da-490d-a65d-c877d9f91b58 0378-1910 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 19981020 ANDA ANDA075150 Mylan Pharmaceuticals Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-1912_5b4d24e7-a6da-490d-a65d-c877d9f91b58 0378-1912 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 19981020 ANDA ANDA075150 Mylan Pharmaceuticals Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-1914_5b4d24e7-a6da-490d-a65d-c877d9f91b58 0378-1914 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 19981020 ANDA ANDA075150 Mylan Pharmaceuticals Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-2002_942272de-0dad-4718-bdce-b745dff16e9e 0378-2002 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 19870623 ANDA ANDA071093 Mylan Pharmaceuticals Inc. THIOTHIXENE 2 mg/1 Typical Antipsychotic [EPC] 0378-2003_59f6e174-8c2a-4459-bef3-777f17e379b4 0378-2003 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080514 ANDA ANDA077873 Mylan Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-2004_59f6e174-8c2a-4459-bef3-777f17e379b4 0378-2004 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080514 ANDA ANDA077873 Mylan Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-2005_59f6e174-8c2a-4459-bef3-777f17e379b4 0378-2005 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110505 ANDA ANDA091427 Mylan Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 37.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-2008_e3d5530d-0e4e-476d-8668-8edecbe54810 0378-2008 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100928 ANDA ANDA090942 Mylan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0378-2009_e3d5530d-0e4e-476d-8668-8edecbe54810 0378-2009 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100928 ANDA ANDA090942 Mylan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0378-2012_40b716ad-a304-492e-8979-2ffe9456d165 0378-2012 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA076113 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-2015_2a2e87e1-f8b6-44d5-b72e-931f5926f837 0378-2015 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20120530 ANDA ANDA091226 Mylan Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-2017_2a2e87e1-f8b6-44d5-b72e-931f5926f837 0378-2017 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20120530 ANDA ANDA091226 Mylan Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-2025_40b716ad-a304-492e-8979-2ffe9456d165 0378-2025 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA076113 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-2042_7da3214d-3cbd-44b4-bcec-7126737f4560 0378-2042 HUMAN PRESCRIPTION DRUG Bromocriptine Mesylate bromocriptine mesylate TABLET ORAL 20130606 ANDA ANDA076962 Mylan Pharmaceuticals Inc. BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 0378-2045_03463d4d-e15e-47cb-899c-18b641081421 0378-2045 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20120723 ANDA ANDA090596 Mylan Pharmaceuticals Inc. TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0378-2046_03463d4d-e15e-47cb-899c-18b641081421 0378-2046 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20120723 ANDA ANDA090596 Mylan Pharmaceuticals Inc. TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0378-2047_03463d4d-e15e-47cb-899c-18b641081421 0378-2047 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20120723 ANDA ANDA090596 Mylan Pharmaceuticals Inc. TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0378-2063_a21ca876-4636-47e5-8c7b-9d23134f61bc 0378-2063 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone atenolol and chlorthalidone TABLET ORAL 20130328 ANDA ANDA074203 Mylan Pharmaceuticals Inc. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0378-2064_a21ca876-4636-47e5-8c7b-9d23134f61bc 0378-2064 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone atenolol and chlorthalidone TABLET ORAL 20130328 ANDA ANDA074203 Mylan Pharmaceuticals Inc. ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0378-2071_15139547-5510-42d2-8cac-ea5e6165b84f 0378-2071 HUMAN PRESCRIPTION DRUG Letrozole Letrozole TABLET, FILM COATED ORAL 20110422 ANDA ANDA078190 Mylan Pharmaceuticals Inc. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 0378-2072_189e65cd-cb24-433c-bb35-a6fb764ebbc2 0378-2072 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA076071 Mylan Pharmaceuticals Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0378-2073_189e65cd-cb24-433c-bb35-a6fb764ebbc2 0378-2073 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA076071 Mylan Pharmaceuticals Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0378-2074_189e65cd-cb24-433c-bb35-a6fb764ebbc2 0378-2074 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA076071 Mylan Pharmaceuticals Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0378-2075_189e65cd-cb24-433c-bb35-a6fb764ebbc2 0378-2075 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA076071 Mylan Pharmaceuticals Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0378-2076_189e65cd-cb24-433c-bb35-a6fb764ebbc2 0378-2076 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA076071 Mylan Pharmaceuticals Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0378-2077_189e65cd-cb24-433c-bb35-a6fb764ebbc2 0378-2077 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA076071 Mylan Pharmaceuticals Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0378-2096_966492d6-a65c-4e7f-9316-a438be06e234 0378-2096 HUMAN PRESCRIPTION DRUG Nisoldipine nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110128 ANDA ANDA091001 Mylan Pharmaceuticals Inc. NISOLDIPINE 8.5 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 0378-2097_966492d6-a65c-4e7f-9316-a438be06e234 0378-2097 HUMAN PRESCRIPTION DRUG Nisoldipine nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110128 ANDA ANDA091001 Mylan Pharmaceuticals Inc. NISOLDIPINE 17 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 0378-2098_966492d6-a65c-4e7f-9316-a438be06e234 0378-2098 HUMAN PRESCRIPTION DRUG Nisoldipine nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110128 ANDA ANDA091001 Mylan Pharmaceuticals Inc. NISOLDIPINE 25.5 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 0378-2099_966492d6-a65c-4e7f-9316-a438be06e234 0378-2099 HUMAN PRESCRIPTION DRUG Nisoldipine nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110128 ANDA ANDA091001 Mylan Pharmaceuticals Inc. NISOLDIPINE 34 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 0378-2100_282cc55b-b17e-42ee-8b13-ac6393ebb6de 0378-2100 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 19910918 ANDA ANDA072741 Mylan Pharmaceuticals Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 0378-2120_183fb627-a66a-46c8-82f4-feba02c2c6f1 0378-2120 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970225 ANDA ANDA074587 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-2121_2a2e87e1-f8b6-44d5-b72e-931f5926f837 0378-2121 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20120530 ANDA ANDA091226 Mylan Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-2122_2a2e87e1-f8b6-44d5-b72e-931f5926f837 0378-2122 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20120530 ANDA ANDA091226 Mylan Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-2146_58035cf5-f25a-4e9b-92ba-e4f8622822aa 0378-2146 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19810203 ANDA ANDA040424 Mylan Pharmaceuticals Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0378-2150_7cba9436-2a59-4ba6-82ef-c4e3c869aa6b 0378-2150 HUMAN PRESCRIPTION DRUG Meclofenamate Sodium meclofenamate sodium CAPSULE ORAL 19860903 ANDA ANDA071081 Mylan Pharmaceuticals Inc. MECLOFENAMATE SODIUM 50 mg/1 0378-2180_183fb627-a66a-46c8-82f4-feba02c2c6f1 0378-2180 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970922 ANDA ANDA074587 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-2222_cd2ad627-d618-43b7-9bb5-e460a99d796b 0378-2222 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080725 ANDA ANDA079051 Mylan Pharmaceuticals Inc. NISOLDIPINE 20 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 0378-2223_cd2ad627-d618-43b7-9bb5-e460a99d796b 0378-2223 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080725 ANDA ANDA079051 Mylan Pharmaceuticals Inc. NISOLDIPINE 30 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 0378-2224_cd2ad627-d618-43b7-9bb5-e460a99d796b 0378-2224 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080725 ANDA ANDA079051 Mylan Pharmaceuticals Inc. NISOLDIPINE 40 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 0378-2250_18396d7c-650c-47e2-a8c7-f205d4094903 0378-2250 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil mycophenolate mofetil CAPSULE ORAL 20090504 ANDA ANDA065520 Mylan Pharmaceuticals Inc. MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 0378-2260_0e2b01c4-15cf-45f4-a2d3-f348646e3a2a 0378-2260 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous terazosin hydrochloride anhydrous CAPSULE ORAL 20000222 ANDA ANDA075140 Mylan Pharmaceuticals Inc. TERAZOSIN HYDROCHLORIDE ANHYDROUS 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0378-2264_0e2b01c4-15cf-45f4-a2d3-f348646e3a2a 0378-2264 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous terazosin hydrochloride anhydrous CAPSULE ORAL 20000222 ANDA ANDA075140 Mylan Pharmaceuticals Inc. TERAZOSIN HYDROCHLORIDE ANHYDROUS 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0378-2268_0e2b01c4-15cf-45f4-a2d3-f348646e3a2a 0378-2268 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous terazosin hydrochloride anhydrous CAPSULE ORAL 20000222 ANDA ANDA075140 Mylan Pharmaceuticals Inc. TERAZOSIN HYDROCHLORIDE ANHYDROUS 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0378-2302_c4992e8d-2a2d-4ea1-a9e7-36afbd6d217e 0378-2302 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 19890228 ANDA ANDA072575 Mylan Pharmaceuticals Inc. PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0378-2321_cf93add3-e7fc-47b7-9aef-75c76a9adfb1 0378-2321 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20061227 ANDA ANDA077657 Mylan Pharmaceuticals Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-2401_f060d8e1-b4f4-4968-879c-d9a909fa4c23 0378-2401 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 19970829 ANDA ANDA040209 Mylan Pharmaceuticals Inc. TRIFLUOPERAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0378-2402_f060d8e1-b4f4-4968-879c-d9a909fa4c23 0378-2402 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 19970829 ANDA ANDA040209 Mylan Pharmaceuticals Inc. TRIFLUOPERAZINE HYDROCHLORIDE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0378-2405_f060d8e1-b4f4-4968-879c-d9a909fa4c23 0378-2405 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 19970829 ANDA ANDA040209 Mylan Pharmaceuticals Inc. TRIFLUOPERAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0378-2410_f060d8e1-b4f4-4968-879c-d9a909fa4c23 0378-2410 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 19970829 ANDA ANDA040209 Mylan Pharmaceuticals Inc. TRIFLUOPERAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0378-2457_cf93add3-e7fc-47b7-9aef-75c76a9adfb1 0378-2457 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20061227 ANDA ANDA077657 Mylan Pharmaceuticals Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-2474_57125085-91bb-477d-b721-42193bffef29 0378-2474 HUMAN PRESCRIPTION DRUG Diclofenac Potassium diclofenac potassium TABLET, FILM COATED ORAL 20120813 ANDA ANDA075463 Mylan Pharmaceuticals Inc. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-2500_5d8d1c06-b4e4-44ef-a1a3-fbd5f6afac1c 0378-2500 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA090408 Mylan Pharmaceuticals Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0378-2511_03dd3301-e9ce-40af-84e1-7b70fc6557b0 0378-2511 HUMAN PRESCRIPTION DRUG Capecitabine capecitabine TABLET, FILM COATED ORAL 20140808 ANDA ANDA090943 Mylan Pharmaceuticals Inc. CAPECITABINE 150 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0378-2512_03dd3301-e9ce-40af-84e1-7b70fc6557b0 0378-2512 HUMAN PRESCRIPTION DRUG Capecitabine capecitabine TABLET, FILM COATED ORAL 20140808 ANDA ANDA090943 Mylan Pharmaceuticals Inc. CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0378-2516_b75dbe49-9a2a-4f8a-916a-42297c0b8f4f 0378-2516 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 20130226 ANDA ANDA076351 Mylan Pharmaceuticals Inc. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0378-2520_b75dbe49-9a2a-4f8a-916a-42297c0b8f4f 0378-2520 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 20130226 ANDA ANDA076351 Mylan Pharmaceuticals Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0378-2537_56dc5e13-45e2-40ea-a334-35facf374790 0378-2537 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide triamterene and hydrochlorothiazide CAPSULE ORAL 19960607 ANDA ANDA074701 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 0378-2586_7ee3e15e-2c40-46fd-b763-082652ef4800 0378-2586 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20100723 ANDA ANDA091176 Mylan Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0378-2587_7ee3e15e-2c40-46fd-b763-082652ef4800 0378-2587 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20100723 ANDA ANDA091176 Mylan Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0378-2588_7ee3e15e-2c40-46fd-b763-082652ef4800 0378-2588 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20100723 ANDA ANDA091176 Mylan Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0378-2589_71c34bd6-b64f-42f7-bf72-9badc44f9574 0378-2589 HUMAN PRESCRIPTION DRUG Fenofibric Acid fenofibric acid CAPSULE, DELAYED RELEASE PELLETS ORAL 20130715 ANDA ANDA200913 Mylan Pharmaceuticals Inc. FENOFIBRIC ACID 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 0378-2590_71c34bd6-b64f-42f7-bf72-9badc44f9574 0378-2590 HUMAN PRESCRIPTION DRUG Fenofibric Acid fenofibric acid CAPSULE, DELAYED RELEASE PELLETS ORAL 20130715 ANDA ANDA200913 Mylan Pharmaceuticals Inc. FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 0378-2610_fa8467f1-64e5-4e00-aaa6-a5ee4078d56d 0378-2610 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19780410 ANDA ANDA086009 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0378-2625_fa8467f1-64e5-4e00-aaa6-a5ee4078d56d 0378-2625 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19780410 ANDA ANDA086009 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0378-2650_fa8467f1-64e5-4e00-aaa6-a5ee4078d56d 0378-2650 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19780410 ANDA ANDA086009 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0378-2658_f1ac14d7-38f7-4373-8abb-87ab600a219b 0378-2658 HUMAN PRESCRIPTION DRUG Morphine Sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111026 ANDA ANDA200824 Mylan Pharmaceuticals Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-2659_f1ac14d7-38f7-4373-8abb-87ab600a219b 0378-2659 HUMAN PRESCRIPTION DRUG Morphine Sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111026 ANDA ANDA200824 Mylan Pharmaceuticals Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-2660_f1ac14d7-38f7-4373-8abb-87ab600a219b 0378-2660 HUMAN PRESCRIPTION DRUG Morphine Sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111026 ANDA ANDA200824 Mylan Pharmaceuticals Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-2661_f1ac14d7-38f7-4373-8abb-87ab600a219b 0378-2661 HUMAN PRESCRIPTION DRUG Morphine Sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111026 ANDA ANDA200824 Mylan Pharmaceuticals Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-2662_f1ac14d7-38f7-4373-8abb-87ab600a219b 0378-2662 HUMAN PRESCRIPTION DRUG Morphine Sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111026 ANDA ANDA200824 Mylan Pharmaceuticals Inc. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-2670_ec8b652e-1f00-4ee4-8412-b63d15029548 0378-2670 HUMAN PRESCRIPTION DRUG Phenytek extended phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20011210 ANDA ANDA040298 Mylan Pharmaceuticals Inc. PHENYTOIN SODIUM 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-2675_fa8467f1-64e5-4e00-aaa6-a5ee4078d56d 0378-2675 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19780410 ANDA ANDA086009 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 0378-2685_fa8467f1-64e5-4e00-aaa6-a5ee4078d56d 0378-2685 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19780410 ANDA ANDA086009 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 0378-2695_fa8467f1-64e5-4e00-aaa6-a5ee4078d56d 0378-2695 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19780410 ANDA ANDA086009 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 0378-2721_f096cfa4-3f5d-4812-ae8e-ead52a400653 0378-2721 HUMAN PRESCRIPTION DRUG Galantamine galantamine TABLET, FILM COATED ORAL 20080829 ANDA ANDA077590 Mylan Pharmaceuticals Inc. GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0378-2722_f096cfa4-3f5d-4812-ae8e-ead52a400653 0378-2722 HUMAN PRESCRIPTION DRUG Galantamine galantamine TABLET, FILM COATED ORAL 20080829 ANDA ANDA077590 Mylan Pharmaceuticals Inc. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0378-2723_f096cfa4-3f5d-4812-ae8e-ead52a400653 0378-2723 HUMAN PRESCRIPTION DRUG Galantamine galantamine TABLET, FILM COATED ORAL 20080829 ANDA ANDA077590 Mylan Pharmaceuticals Inc. GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0378-2777_cf93add3-e7fc-47b7-9aef-75c76a9adfb1 0378-2777 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20061227 ANDA ANDA077657 Mylan Pharmaceuticals Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-2800_e068ef51-a8cb-428a-9ab0-89d482ad7527 0378-2800 HUMAN PRESCRIPTION DRUG Cabergoline cabergoline TABLET ORAL 20131202 ANDA ANDA202947 Mylan Pharmaceuticals Inc. CABERGOLINE .5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 0378-2820_3e5e5ac4-5618-490c-8ba9-90aafc784c78 0378-2820 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20120917 ANDA ANDA091053 Mylan Pharmaceuticals Inc. ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 0378-2821_3e5e5ac4-5618-490c-8ba9-90aafc784c78 0378-2821 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20120917 ANDA ANDA091053 Mylan Pharmaceuticals Inc. ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 0378-2822_3e5e5ac4-5618-490c-8ba9-90aafc784c78 0378-2822 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20120917 ANDA ANDA091053 Mylan Pharmaceuticals Inc. ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 0378-2901_3814089a-6701-476a-9a3a-5e26ab729f67 0378-2901 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide telmisartan and hydrochlorothiazide TABLET ORAL 20140306 ANDA ANDA091648 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-2902_3814089a-6701-476a-9a3a-5e26ab729f67 0378-2902 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide telmisartan and hydrochlorothiazide TABLET ORAL 20140306 ANDA ANDA091648 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-2903_3814089a-6701-476a-9a3a-5e26ab729f67 0378-2903 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide telmisartan and hydrochlorothiazide TABLET ORAL 20140306 ANDA ANDA091648 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 25; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-2920_8e40d481-e277-4957-b38e-254620f8bc30 0378-2920 HUMAN PRESCRIPTION DRUG Telmisartan telmisartan TABLET ORAL 20140707 ANDA ANDA202397 Mylan Pharmaceuticals Inc. TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0378-2921_8e40d481-e277-4957-b38e-254620f8bc30 0378-2921 HUMAN PRESCRIPTION DRUG Telmisartan telmisartan TABLET ORAL 20140707 ANDA ANDA202397 Mylan Pharmaceuticals Inc. TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0378-2922_8e40d481-e277-4957-b38e-254620f8bc30 0378-2922 HUMAN PRESCRIPTION DRUG Telmisartan telmisartan TABLET ORAL 20140707 ANDA ANDA202397 Mylan Pharmaceuticals Inc. TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0378-3000_7cba9436-2a59-4ba6-82ef-c4e3c869aa6b 0378-3000 HUMAN PRESCRIPTION DRUG Meclofenamate Sodium meclofenamate sodium CAPSULE ORAL 19860903 ANDA ANDA071081 Mylan Pharmaceuticals Inc. MECLOFENAMATE SODIUM 100 mg/1 0378-3001_8d2059bd-a881-43bc-b63b-e1110a27095d 0378-3001 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil and Hydrochlorothiazide candesartan cilexetil and hydrochlorothiazide TABLET ORAL 20121204 ANDA ANDA090704 Mylan Pharmaceuticals Inc. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 16; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-3002_8d2059bd-a881-43bc-b63b-e1110a27095d 0378-3002 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil and Hydrochlorothiazide candesartan cilexetil and hydrochlorothiazide TABLET ORAL 20121204 ANDA ANDA090704 Mylan Pharmaceuticals Inc. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-3003_8d2059bd-a881-43bc-b63b-e1110a27095d 0378-3003 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil and Hydrochlorothiazide candesartan cilexetil and hydrochlorothiazide TABLET ORAL 20121204 ANDA ANDA090704 Mylan Pharmaceuticals Inc. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-3005_942272de-0dad-4718-bdce-b745dff16e9e 0378-3005 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 19870623 ANDA ANDA071093 Mylan Pharmaceuticals Inc. THIOTHIXENE 5 mg/1 Typical Antipsychotic [EPC] 0378-3007_4c87bdfd-a76e-4f87-a98f-c12c1a4b9b6a 0378-3007 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 20121019 ANDA ANDA074434 Mylan Pharmaceuticals Inc. CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0378-3012_4c87bdfd-a76e-4f87-a98f-c12c1a4b9b6a 0378-3012 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 20121019 ANDA ANDA074434 Mylan Pharmaceuticals Inc. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0378-3015_241be2cb-42bf-4379-87aa-38708044e67a 0378-3015 HUMAN PRESCRIPTION DRUG Nabumetone nabumetone TABLET, FILM COATED ORAL 20120821 ANDA ANDA090516 Mylan Pharmaceuticals Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-3016_241be2cb-42bf-4379-87aa-38708044e67a 0378-3016 HUMAN PRESCRIPTION DRUG Nabumetone nabumetone TABLET, FILM COATED ORAL 20120821 ANDA ANDA090516 Mylan Pharmaceuticals Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-3017_4c87bdfd-a76e-4f87-a98f-c12c1a4b9b6a 0378-3017 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 20121019 ANDA ANDA074434 Mylan Pharmaceuticals Inc. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0378-3020_fc450645-ec1e-4334-a423-f8f77cf720f3 0378-3020 HUMAN PRESCRIPTION DRUG Famotidine famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075704 Mylan Pharmaceuticals Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0378-3022_4c87bdfd-a76e-4f87-a98f-c12c1a4b9b6a 0378-3022 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 20121019 ANDA ANDA074434 Mylan Pharmaceuticals Inc. CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0378-3023_40c2911a-513f-4558-abb7-1e7d569943c3 0378-3023 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20100218 ANDA ANDA090334 Mylan Pharmaceuticals Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 0378-3024_40c2911a-513f-4558-abb7-1e7d569943c3 0378-3024 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20100218 ANDA ANDA090334 Mylan Pharmaceuticals Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 0378-3025_3fc33d04-d093-410b-b0da-7a430f8e95e1 0378-3025 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride clomipramine hydrochloride CAPSULE ORAL 19980511 ANDA ANDA074947 Mylan Pharmaceuticals Inc. CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0378-3030_db0fb6b4-6299-4ad0-b089-8cc75f56ac82 0378-3030 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate doxycycline hyclate TABLET, DELAYED RELEASE ORAL 20120430 ANDA ANDA091052 Mylan Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 150 mg/1 0378-3033_34278cb7-6207-4432-94ee-bd5b66785ab6 0378-3033 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide TABLET ORAL 20120927 ANDA ANDA077969 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-3034_34278cb7-6207-4432-94ee-bd5b66785ab6 0378-3034 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide irbesartan and hydrochlorothiazide TABLET ORAL 20120927 ANDA ANDA077969 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-3040_fc450645-ec1e-4334-a423-f8f77cf720f3 0378-3040 HUMAN PRESCRIPTION DRUG Famotidine famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075704 Mylan Pharmaceuticals Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0378-3050_3fc33d04-d093-410b-b0da-7a430f8e95e1 0378-3050 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride clomipramine hydrochloride CAPSULE ORAL 19980511 ANDA ANDA074947 Mylan Pharmaceuticals Inc. CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0378-3065_17909e52-e78b-4d26-88da-47846228f212 0378-3065 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20130521 ANDA ANDA202856 Mylan Pharmaceuticals Inc. FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0378-3066_17909e52-e78b-4d26-88da-47846228f212 0378-3066 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20130521 ANDA ANDA202856 Mylan Pharmaceuticals Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0378-3075_3fc33d04-d093-410b-b0da-7a430f8e95e1 0378-3075 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride clomipramine hydrochloride CAPSULE ORAL 19980511 ANDA ANDA074947 Mylan Pharmaceuticals Inc. CLOMIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 0378-3110_4dd09557-80ab-4d40-85a4-9fa2fbeb84e9 0378-3110 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 19860710 ANDA ANDA070920 Mylan Pharmaceuticals Inc. TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-3120_4dd09557-80ab-4d40-85a4-9fa2fbeb84e9 0378-3120 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 19860710 ANDA ANDA070920 Mylan Pharmaceuticals Inc. TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-3121_d3e48c58-5722-4243-bd07-2fe16ea65927 0378-3121 HUMAN PRESCRIPTION DRUG Repaglinide repaglinide TABLET ORAL 20130827 ANDA ANDA090252 Mylan Pharmaceuticals Inc. REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0378-3122_d3e48c58-5722-4243-bd07-2fe16ea65927 0378-3122 HUMAN PRESCRIPTION DRUG Repaglinide repaglinide TABLET ORAL 20140122 ANDA ANDA090252 Mylan Pharmaceuticals Inc. REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0378-3123_d3e48c58-5722-4243-bd07-2fe16ea65927 0378-3123 HUMAN PRESCRIPTION DRUG Repaglinide repaglinide TABLET ORAL 20140122 ANDA ANDA090252 Mylan Pharmaceuticals Inc. REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0378-3125_c9372e19-ac62-4066-93a5-b648b614c633 0378-3125 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Mylan Pharmaceuticals Inc. DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0378-3131_bc95ddbc-5275-47e5-a805-14c998586c39 0378-3131 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride glipizide and metformin hydrochloride TABLET, FILM COATED ORAL 20070412 ANDA ANDA078083 Mylan Pharmaceuticals Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0378-3132_bc95ddbc-5275-47e5-a805-14c998586c39 0378-3132 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride glipizide and metformin hydrochloride TABLET, FILM COATED ORAL 20070412 ANDA ANDA078083 Mylan Pharmaceuticals Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0378-3133_bc95ddbc-5275-47e5-a805-14c998586c39 0378-3133 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride glipizide and metformin hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA078083 Mylan Pharmaceuticals Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0378-3151_46c32640-d14e-4379-90e6-60420e15eeb9 0378-3151 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20070501 ANDA ANDA077578 Mylan Pharmaceuticals Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 0378-3205_c4992e8d-2a2d-4ea1-a9e7-36afbd6d217e 0378-3205 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 19890228 ANDA ANDA072575 Mylan Pharmaceuticals Inc. PRAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0378-3266_e8afb8ba-1f76-47f4-985f-d785d5e66212 0378-3266 HUMAN PRESCRIPTION DRUG Etoposide etoposide CAPSULE ORAL 20011022 ANDA ANDA075635 Mylan Pharmaceuticals Inc. ETOPOSIDE 50 mg/1 Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0378-3286_56783440-7417-4c10-8219-426b60d10943 0378-3286 HUMAN PRESCRIPTION DRUG Etidronate Disodium etidronate disodium TABLET ORAL 20080102 ANDA ANDA075800 Mylan Pharmaceuticals Inc. ETIDRONATE DISODIUM 200 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0378-3288_56783440-7417-4c10-8219-426b60d10943 0378-3288 HUMAN PRESCRIPTION DRUG Etidronate Disodium etidronate disodium TABLET ORAL 20080102 ANDA ANDA075800 Mylan Pharmaceuticals Inc. ETIDRONATE DISODIUM 400 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0378-3340_af85d966-90fd-45a8-aa3e-1a5f37c8e55c 0378-3340 HUMAN PRESCRIPTION DRUG XULANE norelgestromin and ethinyl estradiol PATCH TRANSDERMAL 20140416 ANDA ANDA200910 Mylan Pharmaceuticals Inc. ETHINYL ESTRADIOL; NORELGESTROMIN 35; 150 ug/7d; ug/7d Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0378-3349_398aa5e2-6cac-4ce9-8ca9-84d324426bf0 0378-3349 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20000224 ANDA ANDA075182 Mylan Pharmaceuticals Inc. ESTRADIOL .025 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0378-3350_398aa5e2-6cac-4ce9-8ca9-84d324426bf0 0378-3350 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20050328 ANDA ANDA075182 Mylan Pharmaceuticals Inc. ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0378-3351_398aa5e2-6cac-4ce9-8ca9-84d324426bf0 0378-3351 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20060810 ANDA ANDA075182 Mylan Pharmaceuticals Inc. ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0378-3352_398aa5e2-6cac-4ce9-8ca9-84d324426bf0 0378-3352 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20060810 ANDA ANDA075182 Mylan Pharmaceuticals Inc. ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0378-3360_398aa5e2-6cac-4ce9-8ca9-84d324426bf0 0378-3360 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20000224 ANDA ANDA075182 Mylan Pharmaceuticals Inc. ESTRADIOL .0375 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0378-3361_398aa5e2-6cac-4ce9-8ca9-84d324426bf0 0378-3361 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20050328 ANDA ANDA075182 Mylan Pharmaceuticals Inc. ESTRADIOL .06 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0378-3402_5b1a9b23-e00d-45ee-98a6-2ca43acc2bc3 0378-3402 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20140106 ANDA ANDA201486 Mylan Pharmaceuticals Inc. TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0378-3404_5b1a9b23-e00d-45ee-98a6-2ca43acc2bc3 0378-3404 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20140106 ANDA ANDA201486 Mylan Pharmaceuticals Inc. TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0378-3411_73155556-1586-4733-a353-2d2a5fe21e1e 0378-3411 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100409 ANDA ANDA090325 Mylan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0378-3412_73155556-1586-4733-a353-2d2a5fe21e1e 0378-3412 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100409 ANDA ANDA090325 Mylan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0378-3413_73155556-1586-4733-a353-2d2a5fe21e1e 0378-3413 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100409 ANDA ANDA090325 Mylan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0378-3422_f4b0dcb3-bf1e-4184-9625-37de3720bb3e 0378-3422 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/Macrocrystals Nitrofurantoin Monohydrate and Nitrofurantoin, macrocrystalline CAPSULE ORAL 20120914 ANDA ANDA076648 Mylan Pharmaceuticals Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 0378-3495_3935c038-57eb-4b7e-ab89-657ffeeb78d4 0378-3495 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19890906 20150131 NDA NDA019684 Mylan Pharmaceuticals Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-3502_a46817fc-a570-40ff-9277-615536a4202f 0378-3502 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080915 ANDA ANDA076288 Mylan Pharmaceuticals Inc. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 0378-3505_a46817fc-a570-40ff-9277-615536a4202f 0378-3505 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080915 ANDA ANDA076288 Mylan Pharmaceuticals Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 0378-3511_a46817fc-a570-40ff-9277-615536a4202f 0378-3511 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080915 ANDA ANDA076288 Mylan Pharmaceuticals Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 0378-3512_a46817fc-a570-40ff-9277-615536a4202f 0378-3512 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080915 ANDA ANDA076288 Mylan Pharmaceuticals Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 0378-3513_a46817fc-a570-40ff-9277-615536a4202f 0378-3513 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080915 ANDA ANDA076288 Mylan Pharmaceuticals Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 0378-3514_a46817fc-a570-40ff-9277-615536a4202f 0378-3514 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080915 ANDA ANDA076288 Mylan Pharmaceuticals Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 0378-3515_491de953-3911-4e6e-9b4a-b94c48a433f6 0378-3515 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20121228 ANDA ANDA076122 Mylan Pharmaceuticals Inc. MIRTAZAPINE 15 mg/1 0378-3530_491de953-3911-4e6e-9b4a-b94c48a433f6 0378-3530 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20121228 ANDA ANDA076122 Mylan Pharmaceuticals Inc. MIRTAZAPINE 30 mg/1 0378-3545_491de953-3911-4e6e-9b4a-b94c48a433f6 0378-3545 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20121228 ANDA ANDA076122 Mylan Pharmaceuticals Inc. MIRTAZAPINE 45 mg/1 0378-3547_5c7b4fac-4cee-4f3f-a514-e3cc0faa8398 0378-3547 HUMAN PRESCRIPTION DRUG Mercaptopurine mercaptopurine TABLET ORAL 20050714 ANDA ANDA040594 Mylan Pharmaceuticals Inc. MERCAPTOPURINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0378-3566_6b5ca7e9-b86e-41eb-9473-a3a06557b719 0378-3566 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20080804 ANDA ANDA076584 Mylan Pharmaceuticals Inc. ALENDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0378-3567_6b5ca7e9-b86e-41eb-9473-a3a06557b719 0378-3567 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20080804 ANDA ANDA076584 Mylan Pharmaceuticals Inc. ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0378-3568_6b5ca7e9-b86e-41eb-9473-a3a06557b719 0378-3568 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20110325 ANDA ANDA076584 Mylan Pharmaceuticals Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0378-3569_6b5ca7e9-b86e-41eb-9473-a3a06557b719 0378-3569 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20110325 ANDA ANDA076584 Mylan Pharmaceuticals Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0378-3611_4d294c0f-9142-4fd8-9365-55191778efd5 0378-3611 HUMAN PRESCRIPTION DRUG Liothyronine sodium Liothyronine sodium TABLET ORAL 20130123 ANDA ANDA090326 Mylan Pharmaceuticals Inc. LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 0378-3612_4d294c0f-9142-4fd8-9365-55191778efd5 0378-3612 HUMAN PRESCRIPTION DRUG Liothyronine sodium Liothyronine sodium TABLET ORAL 20130123 ANDA ANDA090326 Mylan Pharmaceuticals Inc. LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 0378-3613_4d294c0f-9142-4fd8-9365-55191778efd5 0378-3613 HUMAN PRESCRIPTION DRUG Liothyronine sodium Liothyronine sodium TABLET ORAL 20130123 ANDA ANDA090326 Mylan Pharmaceuticals Inc. LIOTHYRONINE SODIUM 50 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 0378-3627_11394b85-08f9-48ce-bba3-9efb09b02744 0378-3627 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA077665 Mylan Pharmaceuticals Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 0378-3628_11394b85-08f9-48ce-bba3-9efb09b02744 0378-3628 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA077665 Mylan Pharmaceuticals Inc. CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 0378-3631_cb677d92-9518-47a0-85ad-fefb503f3e06 0378-3631 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077316 Mylan Pharmaceuticals Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0378-3632_cb677d92-9518-47a0-85ad-fefb503f3e06 0378-3632 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077316 Mylan Pharmaceuticals Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0378-3633_cb677d92-9518-47a0-85ad-fefb503f3e06 0378-3633 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077316 Mylan Pharmaceuticals Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0378-3634_cb677d92-9518-47a0-85ad-fefb503f3e06 0378-3634 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077316 Mylan Pharmaceuticals Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0378-3635_2333f981-99e6-4f46-a092-b4e0a3c37985 0378-3635 HUMAN OTC DRUG Cetirizine Hydrochloride cetirizine hydrochloride TABLET, FILM COATED ORAL 20071227 ANDA ANDA076677 Mylan Pharmaceuticals Inc. CETIRIZINE HYDROCHLORIDE 5 mg/1 0378-3637_2333f981-99e6-4f46-a092-b4e0a3c37985 0378-3637 HUMAN OTC DRUG Cetirizine Hydrochloride cetirizine hydrochloride TABLET, FILM COATED ORAL 20071227 ANDA ANDA076677 Mylan Pharmaceuticals Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 0378-3701_950b237e-4bc3-42c4-95a5-a0f4469465a7 0378-3701 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20121231 ANDA ANDA078173 Mylan Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0378-3702_950b237e-4bc3-42c4-95a5-a0f4469465a7 0378-3702 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20121231 ANDA ANDA078173 Mylan Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0378-3750_ec8b652e-1f00-4ee4-8412-b63d15029548 0378-3750 HUMAN PRESCRIPTION DRUG Phenytek phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20011210 ANDA ANDA040298 Mylan Pharmaceuticals Inc. PHENYTOIN SODIUM 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-3850_8cb41ae7-3929-46e5-9c6c-c35b1dabab1e 0378-3850 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin TABLET, CHEWABLE ORAL 20121226 ANDA ANDA200691 Mylan Pharmaceuticals Inc. PHENYTOIN 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-3855_83750539-e8a0-4e77-9836-f0f0580af767 0378-3855 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021323 Mylan Pharmaceuticals Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-3856_83750539-e8a0-4e77-9836-f0f0580af767 0378-3856 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021323 Mylan Pharmaceuticals Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-3857_83750539-e8a0-4e77-9836-f0f0580af767 0378-3857 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021323 Mylan Pharmaceuticals Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-3950_a3ee05e3-83f0-4e56-b5ee-636a707f278d 0378-3950 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20130919 ANDA ANDA091226 Mylan Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-3951_a3ee05e3-83f0-4e56-b5ee-636a707f278d 0378-3951 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20130919 ANDA ANDA091226 Mylan Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-3952_a3ee05e3-83f0-4e56-b5ee-636a707f278d 0378-3952 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20130919 ANDA ANDA091226 Mylan Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-3953_a3ee05e3-83f0-4e56-b5ee-636a707f278d 0378-3953 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20130919 ANDA ANDA091226 Mylan Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-4001_0b8d7601-90bf-4d8e-b057-7aac1eca1c97 0378-4001 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20120723 ANDA ANDA074215 Mylan Pharmaceuticals Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-4003_0b8d7601-90bf-4d8e-b057-7aac1eca1c97 0378-4003 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20100225 ANDA ANDA074215 Mylan Pharmaceuticals Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-4005_0b8d7601-90bf-4d8e-b057-7aac1eca1c97 0378-4005 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19940128 ANDA ANDA074215 Mylan Pharmaceuticals Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-4007_0b8d7601-90bf-4d8e-b057-7aac1eca1c97 0378-4007 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19940128 ANDA ANDA074215 Mylan Pharmaceuticals Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-4010_4dd09557-80ab-4d40-85a4-9fa2fbeb84e9 0378-4010 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 19860710 ANDA ANDA070920 Mylan Pharmaceuticals Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-4011_5e0f0e30-09d4-4ba1-8bee-c755b8a95a4b 0378-4011 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20060301 ANDA ANDA077624 Mylan Pharmaceuticals Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0378-4012_5e0f0e30-09d4-4ba1-8bee-c755b8a95a4b 0378-4012 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20060301 ANDA ANDA077624 Mylan Pharmaceuticals Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0378-4013_5e0f0e30-09d4-4ba1-8bee-c755b8a95a4b 0378-4013 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20060301 ANDA ANDA077624 Mylan Pharmaceuticals Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0378-4017_7ab3ca5c-6a0f-4bca-a7a4-6e153faa4206 0378-4017 HUMAN PRESCRIPTION DRUG Desloratadine desloratadine TABLET, FILM COATED ORAL 20120702 ANDA ANDA078351 Mylan Pharmaceuticals Inc. DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0378-4021_127771c7-3326-41e0-9536-7fbf488b4be8 0378-4021 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 Mylan Pharmaceuticals Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0378-4022_127771c7-3326-41e0-9536-7fbf488b4be8 0378-4022 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 Mylan Pharmaceuticals Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0378-4024_127771c7-3326-41e0-9536-7fbf488b4be8 0378-4024 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 Mylan Pharmaceuticals Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0378-4028_127771c7-3326-41e0-9536-7fbf488b4be8 0378-4028 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 Mylan Pharmaceuticals Inc. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0378-4041_e8ca8261-8a1b-4661-a1af-f12bc2be52b8 0378-4041 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 20121206 ANDA ANDA091590 Mylan Pharmaceuticals Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0378-4042_e8ca8261-8a1b-4661-a1af-f12bc2be52b8 0378-4042 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 20121206 ANDA ANDA091590 Mylan Pharmaceuticals Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0378-4043_e8ca8261-8a1b-4661-a1af-f12bc2be52b8 0378-4043 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 20121206 ANDA ANDA091590 Mylan Pharmaceuticals Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0378-4050_58ffda73-9e4c-418c-bdd6-7e758f0b583a 0378-4050 HUMAN PRESCRIPTION DRUG Nevirapine nevirapine TABLET ORAL 20120522 ANDA ANDA202523 Mylan Pharmaceuticals Inc. NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 0378-4065_26edb47e-eca3-4712-9854-d8c61eac87c8 0378-4065 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Mylan Pharmaceuticals Inc. CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-4066_26edb47e-eca3-4712-9854-d8c61eac87c8 0378-4066 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Mylan Pharmaceuticals Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-4067_26edb47e-eca3-4712-9854-d8c61eac87c8 0378-4067 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Mylan Pharmaceuticals Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-4068_26edb47e-eca3-4712-9854-d8c61eac87c8 0378-4068 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Mylan Pharmaceuticals Inc. CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-4070_25f9c2db-5d57-46b7-8cd5-38310bd1ed40 0378-4070 HUMAN PRESCRIPTION DRUG Ketoprofen ketoprofen CAPSULE ORAL 19970115 ANDA ANDA074035 Mylan Pharmaceuticals Inc. KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-4084_315035fe-f5aa-44a4-9484-161cd1a17e41 0378-4084 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride dexmethylphenidate CAPSULE, EXTENDED RELEASE ORAL 20131118 ANDA ANDA202580 Mylan Pharmaceuticals Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0378-4090_edf8aa6f-66a3-4cab-9c84-1a91cfab02e3 0378-4090 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121016 ANDA ANDA200462 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-4091_edf8aa6f-66a3-4cab-9c84-1a91cfab02e3 0378-4091 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121016 ANDA ANDA200462 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-4092_edf8aa6f-66a3-4cab-9c84-1a91cfab02e3 0378-4092 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121016 ANDA ANDA200462 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-4093_edf8aa6f-66a3-4cab-9c84-1a91cfab02e3 0378-4093 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121016 ANDA ANDA200462 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-4094_edf8aa6f-66a3-4cab-9c84-1a91cfab02e3 0378-4094 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121016 ANDA ANDA200462 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-4095_edf8aa6f-66a3-4cab-9c84-1a91cfab02e3 0378-4095 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121016 ANDA ANDA200462 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-4105_f106c27f-d930-4934-9857-9d70fdd25c26 0378-4105 HUMAN PRESCRIPTION DRUG Abacavir Sulfate abacavir sulfate TABLET, FILM COATED ORAL 20120821 ANDA ANDA091294 Mylan Pharmaceuticals Inc. ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0378-4122_d161ffed-9dc8-4bc6-b32d-564487709b6b 0378-4122 HUMAN PRESCRIPTION DRUG Albuterol Sulfate albuterol sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070130 ANDA ANDA078092 Mylan Pharmaceuticals Inc. ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0378-4124_d161ffed-9dc8-4bc6-b32d-564487709b6b 0378-4124 HUMAN PRESCRIPTION DRUG Albuterol Sulfate albuterol sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070130 ANDA ANDA078092 Mylan Pharmaceuticals Inc. ALBUTEROL SULFATE 8 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0378-4145_5ce58f97-db12-4114-b006-ae60ff35ebcc 0378-4145 HUMAN PRESCRIPTION DRUG Riluzole riluzole TABLET, FILM COATED ORAL 20130722 ANDA ANDA203042 Mylan Pharmaceuticals Inc. RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] 0378-4150_c84225c7-1632-4fd1-93fb-7f6fb8dab476 0378-4150 HUMAN PRESCRIPTION DRUG Risedronate Sodium risedronate sodium TABLET, FILM COATED ORAL 20140610 ANDA ANDA200477 Mylan Pharmaceuticals Inc. RISEDRONATE SODIUM ANHYDROUS 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0378-4151_5f0e39a2-b870-442e-b493-c710e3ff69e4 0378-4151 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride tramadol hydrochloride TABLET, FILM COATED ORAL 20020621 ANDA ANDA075986 Mylan Pharmaceuticals Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 0378-4160_6eed2b56-7d04-482d-b30f-6e29558b4f7a 0378-4160 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20140528 ANDA ANDA202362 Mylan Pharmaceuticals Inc. ATOVAQUONE; PROGUANIL HYDROCHLORIDE 62.5; 25 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 0378-4162_6eed2b56-7d04-482d-b30f-6e29558b4f7a 0378-4162 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20140528 ANDA ANDA202362 Mylan Pharmaceuticals Inc. ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 0378-4201_1da187b6-2664-4bef-8c3e-c66980bd6a33 0378-4201 HUMAN PRESCRIPTION DRUG Mycophenolic Acid mycophenilic acid TABLET, DELAYED RELEASE ORAL 20140108 ANDA ANDA091248 Mylan Pharmaceuticals Inc. MYCOPHENOLIC ACID 180 mg/1 Antimetabolite Immunosuppressant [EPC] 0378-4202_1da187b6-2664-4bef-8c3e-c66980bd6a33 0378-4202 HUMAN PRESCRIPTION DRUG Mycophenolic Acid mycophenilic acid TABLET, DELAYED RELEASE ORAL 20140108 ANDA ANDA091248 Mylan Pharmaceuticals Inc. MYCOPHENOLIC ACID 360 mg/1 Antimetabolite Immunosuppressant [EPC] 0378-4250_c9372e19-ac62-4066-93a5-b648b614c633 0378-4250 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Mylan Pharmaceuticals Inc. DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0378-4251_58ec1e49-6c30-4dce-b63e-47fdddcadfdc 0378-4251 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20121011 ANDA ANDA077420 Mylan Pharmaceuticals Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0378-4252_58ec1e49-6c30-4dce-b63e-47fdddcadfdc 0378-4252 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20121011 ANDA ANDA077420 Mylan Pharmaceuticals Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0378-4253_58ec1e49-6c30-4dce-b63e-47fdddcadfdc 0378-4253 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20121011 ANDA ANDA077420 Mylan Pharmaceuticals Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0378-4254_58ec1e49-6c30-4dce-b63e-47fdddcadfdc 0378-4254 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20121011 ANDA ANDA077420 Mylan Pharmaceuticals Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0378-4260_5e0cccb0-4b46-41ae-8822-97733c2914b0 0378-4260 HUMAN PRESCRIPTION DRUG Zolmitriptan zolmitriptan TABLET, FILM COATED ORAL 20130514 ANDA ANDA203186 Mylan Pharmaceuticals Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0378-4261_5e0cccb0-4b46-41ae-8822-97733c2914b0 0378-4261 HUMAN PRESCRIPTION DRUG Zolmitriptan zolmitriptan TABLET, FILM COATED ORAL 20130514 ANDA ANDA203186 Mylan Pharmaceuticals Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0378-4275_08e00a26-a8eb-4e54-8144-77eb2927a7cc 0378-4275 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA078518 Mylan Pharmaceuticals Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0378-4276_08e00a26-a8eb-4e54-8144-77eb2927a7cc 0378-4276 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA078518 Mylan Pharmaceuticals Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0378-4296_319539ef-d349-47ca-9c85-a714e29602a7 0378-4296 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100720 ANDA ANDA090911 Mylan Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 45 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0378-4297_319539ef-d349-47ca-9c85-a714e29602a7 0378-4297 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100720 ANDA ANDA090911 Mylan Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 90 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0378-4298_319539ef-d349-47ca-9c85-a714e29602a7 0378-4298 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100720 ANDA ANDA090911 Mylan Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 135 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0378-4415_caeb779e-748c-46ca-b4f3-d26caac278af 0378-4415 HUMAN PRESCRIPTION DRUG Flurazepam Hydrochloride flurazepam hydrochloride CAPSULE ORAL 19851127 ANDA ANDA070345 Mylan Pharmaceuticals Inc. FLURAZEPAM HYDROCHLORIDE 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-4430_caeb779e-748c-46ca-b4f3-d26caac278af 0378-4430 HUMAN PRESCRIPTION DRUG Flurazepam Hydrochloride flurazepam hydrochloride CAPSULE ORAL 19851127 ANDA ANDA070345 Mylan Pharmaceuticals Inc. FLURAZEPAM HYDROCHLORIDE 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-4450_ffaff8f5-22c7-43db-895a-9e79d5904fca 0378-4450 HUMAN PRESCRIPTION DRUG Naratriptan naratriptan TABLET, FILM COATED ORAL 20120601 ANDA ANDA202431 Mylan Pharmaceuticals Inc. NARATRIPTAN HYDROCHLORIDE 1 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0378-4451_ffaff8f5-22c7-43db-895a-9e79d5904fca 0378-4451 HUMAN PRESCRIPTION DRUG Naratriptan naratriptan TABLET, FILM COATED ORAL 20120601 ANDA ANDA202431 Mylan Pharmaceuticals Inc. NARATRIPTAN HYDROCHLORIDE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0378-4472_18396d7c-650c-47e2-a8c7-f205d4094903 0378-4472 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil mycophenolate mofetil TABLET, FILM COATED ORAL 20090504 ANDA ANDA065521 Mylan Pharmaceuticals Inc. MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 0378-4490_7e4c46b1-cf17-4e81-b4ac-28e82ac59baf 0378-4490 HUMAN PRESCRIPTION DRUG Famciclovir famciclovir TABLET, FILM COATED ORAL 20110418 ANDA ANDA201333 Mylan Pharmaceuticals Inc. FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0378-4491_7e4c46b1-cf17-4e81-b4ac-28e82ac59baf 0378-4491 HUMAN PRESCRIPTION DRUG Famciclovir famciclovir TABLET, FILM COATED ORAL 20110418 ANDA ANDA201333 Mylan Pharmaceuticals Inc. FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0378-4492_7e4c46b1-cf17-4e81-b4ac-28e82ac59baf 0378-4492 HUMAN PRESCRIPTION DRUG Famciclovir famciclovir TABLET, FILM COATED ORAL 20110418 ANDA ANDA201333 Mylan Pharmaceuticals Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0378-4510_4be76756-4114-4d50-a36c-fd410f6c773d 0378-4510 HUMAN PRESCRIPTION DRUG Amlodipine and Atorvastatin amlodipine and atorvastatin TABLET, FILM COATED ORAL 20140211 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-4511_4be76756-4114-4d50-a36c-fd410f6c773d 0378-4511 HUMAN PRESCRIPTION DRUG Amlodipine and Atorvastatin amlodipine and atorvastatin TABLET, FILM COATED ORAL 20140211 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 2.5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-4512_4be76756-4114-4d50-a36c-fd410f6c773d 0378-4512 HUMAN PRESCRIPTION DRUG Amlodipine and Atorvastatin amlodipine and atorvastatin TABLET, FILM COATED ORAL 20140211 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 2.5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-4513_4be76756-4114-4d50-a36c-fd410f6c773d 0378-4513 HUMAN PRESCRIPTION DRUG Amlodipine and Atorvastatin amlodipine and atorvastatin TABLET, FILM COATED ORAL 20140211 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-4514_4be76756-4114-4d50-a36c-fd410f6c773d 0378-4514 HUMAN PRESCRIPTION DRUG Amlodipine and Atorvastatin amlodipine and atorvastatin TABLET, FILM COATED ORAL 20140211 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-4515_4be76756-4114-4d50-a36c-fd410f6c773d 0378-4515 HUMAN PRESCRIPTION DRUG Amlodipine and Atorvastatin amlodipine and atorvastatin TABLET, FILM COATED ORAL 20140211 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-4516_4be76756-4114-4d50-a36c-fd410f6c773d 0378-4516 HUMAN PRESCRIPTION DRUG Amlodipine and Atorvastatin amlodipine and atorvastatin TABLET, FILM COATED ORAL 20140211 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-4517_4be76756-4114-4d50-a36c-fd410f6c773d 0378-4517 HUMAN PRESCRIPTION DRUG Amlodipine and Atorvastatin amlodipine and atorvastatin TABLET, FILM COATED ORAL 20140211 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-4518_4be76756-4114-4d50-a36c-fd410f6c773d 0378-4518 HUMAN PRESCRIPTION DRUG Amlodipine and Atorvastatin amlodipine and atorvastatin TABLET, FILM COATED ORAL 20140211 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-4519_4be76756-4114-4d50-a36c-fd410f6c773d 0378-4519 HUMAN PRESCRIPTION DRUG Amlodipine and Atorvastatin amlodipine and atorvastatin TABLET, FILM COATED ORAL 20140211 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-4520_4be76756-4114-4d50-a36c-fd410f6c773d 0378-4520 HUMAN PRESCRIPTION DRUG Amlodipine and Atorvastatin amlodipine and atorvastatin TABLET, FILM COATED ORAL 20140211 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-4531_c97b337f-9b62-4c03-be08-996ac6606e22 0378-4531 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate doxycycline hyclate TABLET, DELAYED RELEASE ORAL 20101230 ANDA ANDA090431 Mylan Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 75 mg/1 0378-4532_c97b337f-9b62-4c03-be08-996ac6606e22 0378-4532 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate doxycycline hyclate TABLET, DELAYED RELEASE ORAL 20101230 ANDA ANDA090431 Mylan Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 100 mg/1 0378-4560_c64ed4c0-1e27-42b3-9625-fb4e0d31e271 0378-4560 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140821 ANDA ANDA204662 Mylan Pharmaceuticals Inc. POTASSIUM CHLORIDE 8 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0378-4561_c64ed4c0-1e27-42b3-9625-fb4e0d31e271 0378-4561 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140821 ANDA ANDA204662 Mylan Pharmaceuticals Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0378-4595_c28dafbe-8745-4fd3-87aa-95f7a460de3c 0378-4595 HUMAN PRESCRIPTION DRUG Metoprolol Succinate metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111221 ANDA ANDA202033 Mylan Pharmaceuticals Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-4596_c28dafbe-8745-4fd3-87aa-95f7a460de3c 0378-4596 HUMAN PRESCRIPTION DRUG Metoprolol Succinate metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111221 ANDA ANDA202033 Mylan Pharmaceuticals Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-4597_c28dafbe-8745-4fd3-87aa-95f7a460de3c 0378-4597 HUMAN PRESCRIPTION DRUG Metoprolol Succinate metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111221 ANDA ANDA202033 Mylan Pharmaceuticals Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-4598_c28dafbe-8745-4fd3-87aa-95f7a460de3c 0378-4598 HUMAN PRESCRIPTION DRUG Metoprolol Succinate metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111221 ANDA ANDA202033 Mylan Pharmaceuticals Inc. METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-4640_d28bec8f-762e-4f05-a20d-96a42970d6a7 0378-4640 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20141219 ANDA ANDA201675 Mylan Pharmaceuticals Inc. ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0378-4641_d28bec8f-762e-4f05-a20d-96a42970d6a7 0378-4641 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20141219 ANDA ANDA201675 Mylan Pharmaceuticals Inc. ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0378-4642_d28bec8f-762e-4f05-a20d-96a42970d6a7 0378-4642 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20141219 ANDA ANDA201675 Mylan Pharmaceuticals Inc. ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0378-4643_d28bec8f-762e-4f05-a20d-96a42970d6a7 0378-4643 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20141219 ANDA ANDA201675 Mylan Pharmaceuticals Inc. ESTRADIOL .0375 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0378-4644_d28bec8f-762e-4f05-a20d-96a42970d6a7 0378-4644 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20141219 ANDA ANDA201675 Mylan Pharmaceuticals Inc. ESTRADIOL .025 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0378-4710_f6581324-a1dc-4e2e-be05-871798920dea 0378-4710 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate prednisolone TABLET, ORALLY DISINTEGRATING ORAL 20141208 ANDA ANDA202179 Mylan Pharmaceuticals Inc. PREDNISOLONE SODIUM PHOSPHATE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0378-4715_f6581324-a1dc-4e2e-be05-871798920dea 0378-4715 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate prednisolone TABLET, ORALLY DISINTEGRATING ORAL 20141208 ANDA ANDA202179 Mylan Pharmaceuticals Inc. PREDNISOLONE SODIUM PHOSPHATE 15 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0378-4725_166a8efd-aa21-48bb-a33c-ed0fa051d344 0378-4725 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20121203 ANDA ANDA076688 Mylan Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-4727_c84225c7-1632-4fd1-93fb-7f6fb8dab476 0378-4727 HUMAN PRESCRIPTION DRUG Risedronate Sodium risedronate sodium TABLET, FILM COATED ORAL 20140610 ANDA ANDA200477 Mylan Pharmaceuticals Inc. RISEDRONATE SODIUM ANHYDROUS 75 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0378-4730_f6581324-a1dc-4e2e-be05-871798920dea 0378-4730 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate prednisolone TABLET, ORALLY DISINTEGRATING ORAL 20141208 ANDA ANDA202179 Mylan Pharmaceuticals Inc. PREDNISOLONE SODIUM PHOSPHATE 30 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0378-4735_166a8efd-aa21-48bb-a33c-ed0fa051d344 0378-4735 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20121203 ANDA ANDA076688 Mylan Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-4745_166a8efd-aa21-48bb-a33c-ed0fa051d344 0378-4745 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20121203 ANDA ANDA076688 Mylan Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-4775_166a8efd-aa21-48bb-a33c-ed0fa051d344 0378-4775 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20121203 ANDA ANDA076688 Mylan Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-4791_5238fda5-c3a3-4049-8f93-323833e391eb 0378-4791 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil CREAM TOPICAL 20130723 NDA NDA016831 Mylan Pharmaceuticals Inc. FLUOROURACIL 5 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0378-4881_b0a077a9-d29b-42bd-a3d0-430ed0f853cf 0378-4881 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20080614 ANDA ANDA077166 Mylan Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-4882_b0a077a9-d29b-42bd-a3d0-430ed0f853cf 0378-4882 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20080614 ANDA ANDA077166 Mylan Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-4883_b0a077a9-d29b-42bd-a3d0-430ed0f853cf 0378-4883 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20080614 ANDA ANDA077166 Mylan Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-4884_b0a077a9-d29b-42bd-a3d0-430ed0f853cf 0378-4884 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20080614 ANDA ANDA077166 Mylan Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-4885_b0a077a9-d29b-42bd-a3d0-430ed0f853cf 0378-4885 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20080614 ANDA ANDA077166 Mylan Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-4890_690da74b-2481-47fc-93ae-8340e0caf0a4 0378-4890 HUMAN PRESCRIPTION DRUG Nevirapine nevirapine TABLET, EXTENDED RELEASE ORAL 20141029 ANDA ANDA205651 Mylan Pharmaceuticals Inc. NEVIRAPINE 400 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 0378-5005_9e59a08d-3f92-4e5e-ba66-13c7137fd683 0378-5005 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride alfuzosin TABLET, EXTENDED RELEASE ORAL 20110809 ANDA ANDA079014 Mylan Pharmaceuticals Inc. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0378-5010_942272de-0dad-4718-bdce-b745dff16e9e 0378-5010 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 19870623 ANDA ANDA071093 Mylan Pharmaceuticals Inc. THIOTHIXENE 10 mg/1 Typical Antipsychotic [EPC] 0378-5011_a15c0d57-0b54-43d7-a2b1-49c6274878df 0378-5011 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130328 ANDA ANDA078855 Mylan Pharmaceuticals Inc. FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-5012_a15c0d57-0b54-43d7-a2b1-49c6274878df 0378-5012 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130328 ANDA ANDA078855 Mylan Pharmaceuticals Inc. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-5013_a15c0d57-0b54-43d7-a2b1-49c6274878df 0378-5013 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130328 ANDA ANDA078855 Mylan Pharmaceuticals Inc. FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-5021_deb056d8-b47e-4327-a5d8-a101817aaafb 0378-5021 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET, EXTENDED RELEASE ORAL 20060126 ANDA ANDA077391 Mylan Pharmaceuticals Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-5022_deb056d8-b47e-4327-a5d8-a101817aaafb 0378-5022 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET, EXTENDED RELEASE ORAL 20060126 ANDA ANDA077391 Mylan Pharmaceuticals Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-5040_8a539d67-1b2d-43aa-bba3-510f2f7b878c 0378-5040 HUMAN PRESCRIPTION DRUG Stavudine stavudine CAPSULE ORAL 20110824 ANDA ANDA079069 Mylan Pharmaceuticals Inc. STAVUDINE 15 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0378-5041_8a539d67-1b2d-43aa-bba3-510f2f7b878c 0378-5041 HUMAN PRESCRIPTION DRUG Stavudine stavudine CAPSULE ORAL 20110824 ANDA ANDA079069 Mylan Pharmaceuticals Inc. STAVUDINE 20 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0378-5042_8a539d67-1b2d-43aa-bba3-510f2f7b878c 0378-5042 HUMAN PRESCRIPTION DRUG Stavudine stavudine CAPSULE ORAL 20110824 ANDA ANDA079069 Mylan Pharmaceuticals Inc. STAVUDINE 30 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0378-5043_8a539d67-1b2d-43aa-bba3-510f2f7b878c 0378-5043 HUMAN PRESCRIPTION DRUG Stavudine stavudine CAPSULE ORAL 20110824 ANDA ANDA079069 Mylan Pharmaceuticals Inc. STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0378-5050_4dd09557-80ab-4d40-85a4-9fa2fbeb84e9 0378-5050 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 19860710 ANDA ANDA070920 Mylan Pharmaceuticals Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0378-5051_579306fc-ca98-4ff7-b98d-74dc121e7496 0378-5051 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, ORALLY DISINTEGRATING ORAL 20080918 ANDA ANDA078893 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0378-5052_579306fc-ca98-4ff7-b98d-74dc121e7496 0378-5052 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, ORALLY DISINTEGRATING ORAL 20080918 ANDA ANDA078893 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0378-5053_579306fc-ca98-4ff7-b98d-74dc121e7496 0378-5053 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, ORALLY DISINTEGRATING ORAL 20080918 ANDA ANDA078893 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0378-5100_73a94e0d-4e90-4c82-82ec-e37acdaca549 0378-5100 HUMAN PRESCRIPTION DRUG Itraconazole itraconazole CAPSULE ORAL 20120726 ANDA ANDA200463 Mylan Pharmaceuticals Inc. ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0378-5105_c5356e2e-3440-430b-aa62-457894df9d00 0378-5105 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 19961118 ANDA ANDA040185 Mylan Pharmaceuticals Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0378-5110_c5356e2e-3440-430b-aa62-457894df9d00 0378-5110 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 19961118 ANDA ANDA040185 Mylan Pharmaceuticals Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0378-5111_d4a220de-4721-4f24-97d2-df0fde48d7e9 0378-5111 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride hydralazine hydrochloride TABLET ORAL 20101213 ANDA ANDA090413 Mylan Pharmaceuticals Inc. HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 0378-5112_d4a220de-4721-4f24-97d2-df0fde48d7e9 0378-5112 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride hydralazine hydrochloride TABLET ORAL 20101213 ANDA ANDA090413 Mylan Pharmaceuticals Inc. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 0378-5113_d4a220de-4721-4f24-97d2-df0fde48d7e9 0378-5113 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride hydralazine hydrochloride TABLET ORAL 20101213 ANDA ANDA090413 Mylan Pharmaceuticals Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 0378-5114_d4a220de-4721-4f24-97d2-df0fde48d7e9 0378-5114 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride hydralazine hydrochloride TABLET ORAL 20101213 ANDA ANDA090413 Mylan Pharmaceuticals Inc. HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 0378-5123_34a02845-f72e-4944-90ab-b069e10c2e59 0378-5123 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride sotalol hydrochloride TABLET ORAL 20070220 ANDA ANDA077616 Mylan Pharmaceuticals Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 0378-5124_34a02845-f72e-4944-90ab-b069e10c2e59 0378-5124 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride sotalol hydrochloride TABLET ORAL 20070220 ANDA ANDA077616 Mylan Pharmaceuticals Inc. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC] 0378-5125_34a02845-f72e-4944-90ab-b069e10c2e59 0378-5125 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride sotalol hydrochloride TABLET ORAL 20070220 ANDA ANDA077616 Mylan Pharmaceuticals Inc. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC] 0378-5144_a20593d6-f348-4e2d-b44f-9ff063376018 0378-5144 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA090521 Mylan Pharmaceuticals Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0378-5145_a20593d6-f348-4e2d-b44f-9ff063376018 0378-5145 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA090521 Mylan Pharmaceuticals Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0378-5150_505555b2-7534-4269-9569-638814a7b8d1 0378-5150 HUMAN PRESCRIPTION DRUG Nizatidine nizatidine CAPSULE ORAL 20110504 ANDA ANDA075806 Mylan Pharmaceuticals Inc. NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0378-5157_f038ce67-6738-4dc0-9190-abb176e77799 0378-5157 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, FILM COATED ORAL 20130408 ANDA ANDA076866 Mylan Pharmaceuticals Inc. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 0378-5180_ee4524a7-cb68-4a43-ae23-facd5db651bf 0378-5180 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine lamivudine and zidovudine TABLET, FILM COATED ORAL 20140930 ANDA ANDA204005 Mylan Pharmaceuticals Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0378-5200_ed3d0907-14e3-41a5-8afb-6d7cd4edca4b 0378-5200 HUMAN PRESCRIPTION DRUG Tolmetin Sodium tolmetin Sodium CAPSULE ORAL 19930527 ANDA ANDA073393 Mylan Pharmaceuticals Inc. TOLMETIN SODIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-5201_679c3380-da63-47bd-b23f-8fde85587d17 0378-5201 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA079103 Mylan Pharmaceuticals Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0378-5204_679c3380-da63-47bd-b23f-8fde85587d17 0378-5204 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA079142 Mylan Pharmaceuticals Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0378-5205_679c3380-da63-47bd-b23f-8fde85587d17 0378-5205 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA079142 Mylan Pharmaceuticals Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0378-5208_d90a92f5-ec5c-4bf5-b659-401468ea6f65 0378-5208 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20070323 ANDA ANDA076418 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-5209_d90a92f5-ec5c-4bf5-b659-401468ea6f65 0378-5209 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20070323 ANDA ANDA076418 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-5210_d90a92f5-ec5c-4bf5-b659-401468ea6f65 0378-5210 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20070323 ANDA ANDA076418 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0378-5211_50163460-8125-4b49-90c1-629f973824b0 0378-5211 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20030804 ANDA ANDA075876 Mylan Pharmaceuticals Inc. OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0378-5212_f038ce67-6738-4dc0-9190-abb176e77799 0378-5212 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, FILM COATED ORAL 20130408 ANDA ANDA076866 Mylan Pharmaceuticals Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 0378-5215_184a3eeb-c450-4380-b597-e81503dd51c6 0378-5215 HUMAN PRESCRIPTION DRUG Ibandronate Sodium ibandronate sodium TABLET, FILM COATED ORAL 20120319 ANDA ANDA078995 Mylan Pharmaceuticals Inc. IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0378-5220_1408c422-e3cb-4bcd-b338-eeb6a23ec4eb 0378-5220 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120606 ANDA ANDA075124 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-5222_50163460-8125-4b49-90c1-629f973824b0 0378-5222 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20090122 ANDA ANDA075876 Mylan Pharmaceuticals Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0378-5270_841f31e9-3083-43c8-b886-e3c077f57063 0378-5270 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20130326 ANDA ANDA091151 Mylan Pharmaceuticals Inc. ESZOPICLONE 1 mg/1 CIV 0378-5271_841f31e9-3083-43c8-b886-e3c077f57063 0378-5271 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20130326 ANDA ANDA091151 Mylan Pharmaceuticals Inc. ESZOPICLONE 2 mg/1 CIV 0378-5272_841f31e9-3083-43c8-b886-e3c077f57063 0378-5272 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20130326 ANDA ANDA091151 Mylan Pharmaceuticals Inc. ESZOPICLONE 3 mg/1 CIV 0378-5280_1408c422-e3cb-4bcd-b338-eeb6a23ec4eb 0378-5280 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120606 ANDA ANDA075124 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-5300_505555b2-7534-4269-9569-638814a7b8d1 0378-5300 HUMAN PRESCRIPTION DRUG Nizatidine nizatidine CAPSULE ORAL 20110506 ANDA ANDA075806 Mylan Pharmaceuticals Inc. NIZATIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0378-5305_26c39335-0563-4ece-aa7c-bf5708c915e2 0378-5305 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076578 Mylan Pharmaceuticals Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0378-5310_26c39335-0563-4ece-aa7c-bf5708c915e2 0378-5310 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076578 Mylan Pharmaceuticals Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0378-5335_f038ce67-6738-4dc0-9190-abb176e77799 0378-5335 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, FILM COATED ORAL 20130408 ANDA ANDA076866 Mylan Pharmaceuticals Inc. OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 0378-5340_1408c422-e3cb-4bcd-b338-eeb6a23ec4eb 0378-5340 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120606 ANDA ANDA075124 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-5375_c9372e19-ac62-4066-93a5-b648b614c633 0378-5375 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Mylan Pharmaceuticals Inc. DOXEPIN HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 0378-5410_7dc858f4-e7af-4db3-91b0-92c2d35df29f 0378-5410 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride CAPSULE ORAL 20081117 ANDA ANDA078045 Mylan Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-5420_7dc858f4-e7af-4db3-91b0-92c2d35df29f 0378-5420 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride CAPSULE ORAL 20081117 ANDA ANDA078045 Mylan Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-5424_e2ebf80a-1998-4dd8-9908-baaa6a26a9e9 0378-5424 HUMAN PRESCRIPTION DRUG Gabapentin gabapentin TABLET ORAL 20120831 ANDA ANDA090335 Mylan Pharmaceuticals Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-5425_e2ebf80a-1998-4dd8-9908-baaa6a26a9e9 0378-5425 HUMAN PRESCRIPTION DRUG Gabapentin gabapentin TABLET ORAL 20120831 ANDA ANDA090335 Mylan Pharmaceuticals Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-5426_c2f6b41f-4e59-4f2b-8684-ec68bd545df4 0378-5426 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110214 ANDA ANDA090158 Mylan Pharmaceuticals Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-5427_c2f6b41f-4e59-4f2b-8684-ec68bd545df4 0378-5427 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110214 ANDA ANDA090158 Mylan Pharmaceuticals Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-5428_c2f6b41f-4e59-4f2b-8684-ec68bd545df4 0378-5428 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110214 ANDA ANDA090158 Mylan Pharmaceuticals Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-5445_bfc370b4-6a62-44de-a353-dd59768e3133 0378-5445 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate tolterodine TABLET, FILM COATED ORAL 20121128 ANDA ANDA202641 Mylan Pharmaceuticals Inc. TOLTERODINE TARTRATE 1 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0378-5446_bfc370b4-6a62-44de-a353-dd59768e3133 0378-5446 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate tolterodine TABLET, FILM COATED ORAL 20121128 ANDA ANDA202641 Mylan Pharmaceuticals Inc. TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0378-5454_f038ce67-6738-4dc0-9190-abb176e77799 0378-5454 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, FILM COATED ORAL 20130408 ANDA ANDA076866 Mylan Pharmaceuticals Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 0378-5475_4254c4af-ef98-48cc-90d0-9490bb67c53c 0378-5475 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20120612 ANDA ANDA202778 Mylan Pharmaceuticals Inc. DOXYCYCLINE 150 mg/1 0378-5485_930da37c-bf64-4b72-a02a-d41778bed532 0378-5485 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20120919 ANDA ANDA202640 Mylan Pharmaceuticals Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 0378-5486_930da37c-bf64-4b72-a02a-d41778bed532 0378-5486 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20120919 ANDA ANDA202640 Mylan Pharmaceuticals Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 0378-5501_b8402d27-c4e6-4cba-8e11-a1ac9f047c5b 0378-5501 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20080505 ANDA ANDA078881 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-5502_b8402d27-c4e6-4cba-8e11-a1ac9f047c5b 0378-5502 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20080505 ANDA ANDA078881 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-5503_b8402d27-c4e6-4cba-8e11-a1ac9f047c5b 0378-5503 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20080505 ANDA ANDA078881 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-5504_b8402d27-c4e6-4cba-8e11-a1ac9f047c5b 0378-5504 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20080505 ANDA ANDA078881 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-5505_b8402d27-c4e6-4cba-8e11-a1ac9f047c5b 0378-5505 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20080505 ANDA ANDA078881 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-5510_35b52ceb-5c07-49c5-9b1d-4708db66eaff 0378-5510 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140512 ANDA ANDA202285 Mylan Pharmaceuticals Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 0378-5511_35b52ceb-5c07-49c5-9b1d-4708db66eaff 0378-5511 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140512 ANDA ANDA202285 Mylan Pharmaceuticals Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 0378-5512_35b52ceb-5c07-49c5-9b1d-4708db66eaff 0378-5512 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140512 ANDA ANDA202285 Mylan Pharmaceuticals Inc. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 0378-5513_35b52ceb-5c07-49c5-9b1d-4708db66eaff 0378-5513 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140512 ANDA ANDA202285 Mylan Pharmaceuticals Inc. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 0378-5521_01f39bad-4059-4ae7-a8fb-a9722692c943 0378-5521 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100514 ANDA ANDA090941 Mylan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0378-5522_f038ce67-6738-4dc0-9190-abb176e77799 0378-5522 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, FILM COATED ORAL 20130408 ANDA ANDA076866 Mylan Pharmaceuticals Inc. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 0378-5525_b8402d27-c4e6-4cba-8e11-a1ac9f047c5b 0378-5525 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20080505 ANDA ANDA078881 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-5550_b8402d27-c4e6-4cba-8e11-a1ac9f047c5b 0378-5550 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20080505 ANDA ANDA078881 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0378-5573_9df7eb18-b383-4e8a-b661-2b3924771c92 0378-5573 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20120810 ANDA ANDA076594 Mylan Pharmaceuticals Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 0378-5575_9df7eb18-b383-4e8a-b661-2b3924771c92 0378-5575 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20120810 ANDA ANDA076594 Mylan Pharmaceuticals Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 0378-5613_2ea79a3d-714d-431d-b120-6b391f22506f 0378-5613 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20081104 ANDA ANDA076919 Mylan Pharmaceuticals Inc. LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-5615_2ea79a3d-714d-431d-b120-6b391f22506f 0378-5615 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20081104 ANDA ANDA076919 Mylan Pharmaceuticals Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-5617_2ea79a3d-714d-431d-b120-6b391f22506f 0378-5617 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20081104 ANDA ANDA076919 Mylan Pharmaceuticals Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-5619_2ea79a3d-714d-431d-b120-6b391f22506f 0378-5619 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20091210 ANDA ANDA090261 Mylan Pharmaceuticals Inc. LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-5630_18554375-e945-4b78-ba9b-6f202addd26e 0378-5630 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA077744 Mylan Pharmaceuticals Inc. SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0378-5631_18554375-e945-4b78-ba9b-6f202addd26e 0378-5631 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA077744 Mylan Pharmaceuticals Inc. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0378-5632_18554375-e945-4b78-ba9b-6f202addd26e 0378-5632 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA077744 Mylan Pharmaceuticals Inc. SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0378-5713_f038ce67-6738-4dc0-9190-abb176e77799 0378-5713 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, FILM COATED ORAL 20130408 ANDA ANDA076866 Mylan Pharmaceuticals Inc. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 0378-5750_25f9c2db-5d57-46b7-8cd5-38310bd1ed40 0378-5750 HUMAN PRESCRIPTION DRUG Ketoprofen ketoprofen CAPSULE ORAL 19970115 ANDA ANDA074035 Mylan Pharmaceuticals Inc. KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-6004_2ab1e2e6-7efa-48b5-88e7-f6f87dcb863b 0378-6004 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride fluphenazine hydrochloride TABLET, FILM COATED ORAL 19880812 ANDA ANDA089804 Mylan Pharmaceuticals Inc. FLUPHENAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0378-6009_2ab1e2e6-7efa-48b5-88e7-f6f87dcb863b 0378-6009 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride fluphenazine hydrochloride TABLET, FILM COATED ORAL 19880812 ANDA ANDA089804 Mylan Pharmaceuticals Inc. FLUPHENAZINE HYDROCHLORIDE 2.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0378-6015_891be6db-069f-41f0-8ee0-cc7bc8278636 0378-6015 HUMAN PRESCRIPTION DRUG oxybutynin chloride oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 20070510 NDA NDA020897 Mylan Pharmaceuticals Inc. OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0378-6021_17078291-2798-4ed4-8a81-dc3dacc7d223 0378-6021 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20061117 ANDA ANDA065377 Mylan Pharmaceuticals Inc. DOXYCYCLINE 50 mg/1 0378-6022_17078291-2798-4ed4-8a81-dc3dacc7d223 0378-6022 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20061117 ANDA ANDA065377 Mylan Pharmaceuticals Inc. DOXYCYCLINE 75 mg/1 0378-6023_17078291-2798-4ed4-8a81-dc3dacc7d223 0378-6023 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20061117 ANDA ANDA065377 Mylan Pharmaceuticals Inc. DOXYCYCLINE 100 mg/1 0378-6034_71757666-90f3-490c-835e-ac1ab478dfe1 0378-6034 HUMAN PRESCRIPTION DRUG Anastrozole anastrozole TABLET, FILM COATED ORAL 20100628 ANDA ANDA091051 Mylan Pharmaceuticals Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 0378-6040_49606f12-b772-4adc-9fd7-ed8f96f249cd 0378-6040 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast GRANULE ORAL 20130918 ANDA ANDA202776 Mylan Pharmaceuticals Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0378-6042_c62d967a-ca38-4230-81c5-b0306410a89f 0378-6042 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20130311 ANDA ANDA091537 Mylan Pharmaceuticals Inc. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 0378-6043_c62d967a-ca38-4230-81c5-b0306410a89f 0378-6043 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20110511 ANDA ANDA091537 Mylan Pharmaceuticals Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 0378-6044_c62d967a-ca38-4230-81c5-b0306410a89f 0378-6044 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20110511 ANDA ANDA091537 Mylan Pharmaceuticals Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 0378-6045_c62d967a-ca38-4230-81c5-b0306410a89f 0378-6045 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20110511 ANDA ANDA091537 Mylan Pharmaceuticals Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 0378-6046_c62d967a-ca38-4230-81c5-b0306410a89f 0378-6046 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20110511 ANDA ANDA091537 Mylan Pharmaceuticals Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 0378-6047_c62d967a-ca38-4230-81c5-b0306410a89f 0378-6047 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20110511 ANDA ANDA091537 Mylan Pharmaceuticals Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 0378-6060_5d57c2f5-1287-4d58-98d5-b441c78e6d82 0378-6060 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19970502 ANDA ANDA074910 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-6068_84308c49-dcf7-4d24-a45a-2b75c52648af 0378-6068 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride clindamycin hydrochloride CAPSULE ORAL 20130507 ANDA ANDA091225 Mylan Pharmaceuticals Inc. CLINDAMYCIN HYDROCHLORIDE 75 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0378-6069_84308c49-dcf7-4d24-a45a-2b75c52648af 0378-6069 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride clindamycin hydrochloride CAPSULE ORAL 20130507 ANDA ANDA091225 Mylan Pharmaceuticals Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0378-6070_84308c49-dcf7-4d24-a45a-2b75c52648af 0378-6070 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride clindamycin hydrochloride CAPSULE ORAL 20130507 ANDA ANDA091225 Mylan Pharmaceuticals Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0378-6074_2ab1e2e6-7efa-48b5-88e7-f6f87dcb863b 0378-6074 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride fluphenazine hydrochloride TABLET, FILM COATED ORAL 19880812 ANDA ANDA089804 Mylan Pharmaceuticals Inc. FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0378-6088_69a77a15-f81d-41af-a0d4-7efec301d988 0378-6088 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20130222 ANDA ANDA202579 Mylan Pharmaceuticals Inc. FENOFIBRATE 43 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0378-6089_69a77a15-f81d-41af-a0d4-7efec301d988 0378-6089 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20130222 ANDA ANDA202579 Mylan Pharmaceuticals Inc. FENOFIBRATE 130 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0378-6090_5d57c2f5-1287-4d58-98d5-b441c78e6d82 0378-6090 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19970502 ANDA ANDA074910 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-6097_2ab1e2e6-7efa-48b5-88e7-f6f87dcb863b 0378-6097 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride fluphenazine hydrochloride TABLET, FILM COATED ORAL 19880812 ANDA ANDA089804 Mylan Pharmaceuticals Inc. FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0378-6101_bf1a251c-589c-4c97-98cb-dc156cd68461 0378-6101 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20121212 ANDA ANDA076314 Mylan Pharmaceuticals Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-6102_bf1a251c-589c-4c97-98cb-dc156cd68461 0378-6102 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20121212 ANDA ANDA076314 Mylan Pharmaceuticals Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-6103_bf1a251c-589c-4c97-98cb-dc156cd68461 0378-6103 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20121212 ANDA ANDA076314 Mylan Pharmaceuticals Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-6105_bf1a251c-589c-4c97-98cb-dc156cd68461 0378-6105 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20121212 ANDA ANDA076314 Mylan Pharmaceuticals Inc. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-6106_54b75503-313f-4e9a-9b9c-40dad913fdef 0378-6106 HUMAN PRESCRIPTION DRUG Zidovudine zidovudine TABLET, FILM COATED ORAL 20081219 ANDA ANDA078922 Mylan Pharmaceuticals Inc. ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0378-6112_18a72365-8f87-47ca-8dce-25d739f342a8 0378-6112 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 ANDA ANDA091313 Mylan Pharmaceuticals Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-6113_18a72365-8f87-47ca-8dce-25d739f342a8 0378-6113 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 ANDA ANDA091313 Mylan Pharmaceuticals Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-6114_18a72365-8f87-47ca-8dce-25d739f342a8 0378-6114 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 ANDA ANDA091313 Mylan Pharmaceuticals Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-6117_671f8f36-88e3-44e8-a597-376fe74bb831 0378-6117 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride and Aspirin Oxycodone Hydrochloride and Aspirin TABLET ORAL 20110502 ANDA ANDA091670 Mylan Pharmaceuticals Inc. ASPIRIN; OXYCODONE HYDROCHLORIDE 325; 4.8355 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 0378-6120_5d57c2f5-1287-4d58-98d5-b441c78e6d82 0378-6120 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19970502 ANDA ANDA074910 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-6124_17078291-2798-4ed4-8a81-dc3dacc7d223 0378-6124 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20070608 ANDA ANDA065427 Mylan Pharmaceuticals Inc. DOXYCYCLINE 150 mg/1 0378-6140_1d1bb5b1-667c-4d47-917e-06bd0964d4ee 0378-6140 HUMAN PRESCRIPTION DRUG Avita Tretinoin GEL TOPICAL 19980318 NDA NDA020400 Mylan Pharmaceuticals Inc. TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0378-6141_6e24b2f5-28f1-4cc4-80cf-d0f327717926 0378-6141 HUMAN PRESCRIPTION DRUG Avita tretinoin CREAM TOPICAL 20110520 NDA NDA020404 Mylan Pharmaceuticals Inc. TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0378-6150_50163460-8125-4b49-90c1-629f973824b0 0378-6150 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20030804 ANDA ANDA075876 Mylan Pharmaceuticals Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0378-6151_4b1bf215-d98a-40ab-b88c-a4aa5af0636d 0378-6151 HUMAN PRESCRIPTION DRUG MENTAX butenafine hydrochloride CREAM TOPICAL 19961231 NDA NDA020663 Mylan Pharmaceuticals Inc. BUTENAFINE HYDROCHLORIDE 10 mg/g Benzylamine Antifungal [EPC],Benzylamines [Chemical/Ingredient] 0378-6155_ab2c9cb5-a882-4518-a42f-5aac9ff5709c 0378-6155 HUMAN PRESCRIPTION DRUG DIGITEK digoxin TABLET ORAL 20141117 ANDA ANDA040282 Mylan Pharmaceuticals Inc. DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0378-6156_ab2c9cb5-a882-4518-a42f-5aac9ff5709c 0378-6156 HUMAN PRESCRIPTION DRUG DIGITEK digoxin TABLET ORAL 20141117 ANDA ANDA040282 Mylan Pharmaceuticals Inc. DIGOXIN .25 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0378-6160_9704e4bd-1673-490f-83b9-35379eaeb9fd 0378-6160 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070215 ANDA ANDA078022 Mylan Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-6161_98e2cdd3-3554-46ac-a8a5-ba5af9c2d547 0378-6161 HUMAN PRESCRIPTION DRUG Amlodipine besylate/atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA021540 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-6162_98e2cdd3-3554-46ac-a8a5-ba5af9c2d547 0378-6162 HUMAN PRESCRIPTION DRUG Amlodipine besylate/atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA021540 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-6163_98e2cdd3-3554-46ac-a8a5-ba5af9c2d547 0378-6163 HUMAN PRESCRIPTION DRUG Amlodipine besylate/atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA021540 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-6164_98e2cdd3-3554-46ac-a8a5-ba5af9c2d547 0378-6164 HUMAN PRESCRIPTION DRUG Amlodipine besylate/atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA021540 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-6165_98e2cdd3-3554-46ac-a8a5-ba5af9c2d547 0378-6165 HUMAN PRESCRIPTION DRUG Amlodipine besylate/atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA021540 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-6166_98e2cdd3-3554-46ac-a8a5-ba5af9c2d547 0378-6166 HUMAN PRESCRIPTION DRUG Amlodipine besylate/atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA021540 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-6167_98e2cdd3-3554-46ac-a8a5-ba5af9c2d547 0378-6167 HUMAN PRESCRIPTION DRUG Amlodipine besylate/atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA021540 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-6168_98e2cdd3-3554-46ac-a8a5-ba5af9c2d547 0378-6168 HUMAN PRESCRIPTION DRUG Amlodipine besylate/atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA021540 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-6169_98e2cdd3-3554-46ac-a8a5-ba5af9c2d547 0378-6169 HUMAN PRESCRIPTION DRUG Amlodipine besylate/atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA021540 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-6170_98e2cdd3-3554-46ac-a8a5-ba5af9c2d547 0378-6170 HUMAN PRESCRIPTION DRUG Amlodipine besylate/atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA021540 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-6171_98e2cdd3-3554-46ac-a8a5-ba5af9c2d547 0378-6171 HUMAN PRESCRIPTION DRUG Amlodipine besylate/atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA021540 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-6172_cd268401-396a-44bc-a14b-2888ed86ab05 0378-6172 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20040106 ANDA ANDA076698 Mylan Pharmaceuticals Inc. METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0378-6173_cd268401-396a-44bc-a14b-2888ed86ab05 0378-6173 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20041019 ANDA ANDA076698 Mylan Pharmaceuticals Inc. METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0378-6174_cd268401-396a-44bc-a14b-2888ed86ab05 0378-6174 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20041019 ANDA ANDA076698 Mylan Pharmaceuticals Inc. METOLAZONE 10 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0378-6180_9704e4bd-1673-490f-83b9-35379eaeb9fd 0378-6180 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070215 ANDA ANDA078022 Mylan Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-6201_3f217eca-1cdb-49f4-92d5-013fb9b2c28d 0378-6201 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070809 ANDA ANDA078306 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 100 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-6202_3f217eca-1cdb-49f4-92d5-013fb9b2c28d 0378-6202 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070809 ANDA ANDA078306 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 200 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-6203_3f217eca-1cdb-49f4-92d5-013fb9b2c28d 0378-6203 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070809 ANDA ANDA078306 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-6220_9704e4bd-1673-490f-83b9-35379eaeb9fd 0378-6220 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070215 ANDA ANDA078022 Mylan Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-6231_eb7d6b15-2104-4284-a068-54df40eb34db 0378-6231 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20080728 ANDA ANDA077042 Mylan Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-6232_eb7d6b15-2104-4284-a068-54df40eb34db 0378-6232 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20080728 ANDA ANDA077042 Mylan Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-6233_eb7d6b15-2104-4284-a068-54df40eb34db 0378-6233 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20080728 ANDA ANDA077042 Mylan Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-6260_9704e4bd-1673-490f-83b9-35379eaeb9fd 0378-6260 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070215 ANDA ANDA078022 Mylan Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0378-6270_0aeb399e-6038-402a-aa0b-cb6c7e8cbc8a 0378-6270 HUMAN PRESCRIPTION DRUG Voriconazole voriconazole POWDER, FOR SUSPENSION ORAL 20130925 ANDA ANDA202361 Mylan Pharmaceuticals Inc. VORICONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0378-6280_00c44bc0-d8cb-4e59-97b0-89cf89519f8a 0378-6280 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 20100518 ANDA ANDA075281 Mylan Pharmaceuticals Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-6281_00c44bc0-d8cb-4e59-97b0-89cf89519f8a 0378-6281 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 20100518 ANDA ANDA075281 Mylan Pharmaceuticals Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-6320_2ddc6c92-2733-4c9b-97ee-4b37d00fe65c 0378-6320 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130325 ANDA ANDA075138 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-6321_24afd973-4138-4a6e-b5f5-901a2464d4ea 0378-6321 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 ANDA ANDA078020 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-6322_24afd973-4138-4a6e-b5f5-901a2464d4ea 0378-6322 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 ANDA ANDA078020 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-6323_24afd973-4138-4a6e-b5f5-901a2464d4ea 0378-6323 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 ANDA ANDA078020 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-6324_24afd973-4138-4a6e-b5f5-901a2464d4ea 0378-6324 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 ANDA ANDA078020 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-6325_24afd973-4138-4a6e-b5f5-901a2464d4ea 0378-6325 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 ANDA ANDA078020 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0378-6333_1b4d1065-ae01-46c8-904d-8a013cebe2a7 0378-6333 HUMAN PRESCRIPTION DRUG Acamprosate Calcium acamprosate calcium enteric-coated TABLET, DELAYED RELEASE ORAL 20140924 ANDA ANDA200142 Mylan Pharmaceuticals Inc. ACAMPROSATE CALCIUM 333 mg/1 0378-6380_2ddc6c92-2733-4c9b-97ee-4b37d00fe65c 0378-6380 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130325 ANDA ANDA075138 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-6410_c9372e19-ac62-4066-93a5-b648b614c633 0378-6410 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Mylan Pharmaceuticals Inc. DOXEPIN HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 0378-6440_2ddc6c92-2733-4c9b-97ee-4b37d00fe65c 0378-6440 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130325 ANDA ANDA075138 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0378-6510_1aabb5db-8f02-4d6c-a3a4-591c9fc78869 0378-6510 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075451 Mylan Pharmaceuticals Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-6520_1aabb5db-8f02-4d6c-a3a4-591c9fc78869 0378-6520 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075451 Mylan Pharmaceuticals Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-6540_1aabb5db-8f02-4d6c-a3a4-591c9fc78869 0378-6540 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075451 Mylan Pharmaceuticals Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-6550_8cca0a2f-cbbe-4a57-9166-8ce5beaa6d21 0378-6550 HUMAN PRESCRIPTION DRUG LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol and levonorgestrel KIT 20130816 ANDA ANDA091663 Mylan Pharmaceuticals Inc. 0378-6605_4299eef5-947e-41a9-a59f-462fe14a6366 0378-6605 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20061110 ANDA ANDA076702 Mylan Pharmaceuticals Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0378-6610_4299eef5-947e-41a9-a59f-462fe14a6366 0378-6610 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20061110 ANDA ANDA076644 Mylan Pharmaceuticals Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0378-6611_c8aa924f-4df9-4193-b436-6e90d95a5e3c 0378-6611 HUMAN PRESCRIPTION DRUG Amnesteem isotretinoin CAPSULE ORAL 20021111 ANDA ANDA075945 Mylan Pharmaceuticals Inc. ISOTRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 0378-6612_c8aa924f-4df9-4193-b436-6e90d95a5e3c 0378-6612 HUMAN PRESCRIPTION DRUG Amnesteem isotretinoin CAPSULE ORAL 20021111 ANDA ANDA075945 Mylan Pharmaceuticals Inc. ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 0378-6614_c8aa924f-4df9-4193-b436-6e90d95a5e3c 0378-6614 HUMAN PRESCRIPTION DRUG Amnesteem isotretinoin CAPSULE ORAL 20021111 ANDA ANDA075945 Mylan Pharmaceuticals Inc. ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 0378-6629_17740ef7-2a69-4a48-b272-ed178ecab3e0 0378-6629 HUMAN PRESCRIPTION DRUG Eprosartan Mesylate eprosartan mesylate TABLET, FILM COATED ORAL 20111220 ANDA ANDA202012 Mylan Pharmaceuticals Inc. EPROSARTAN MESYLATE 600 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0378-6669_29dd5355-2141-4a66-aa06-43708b3b33c7 0378-6669 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 and Electrolytes polyethylene glycol 3350 and electrolytes for oral solution POWDER, FOR SOLUTION ORAL 20100202 ANDA ANDA090928 Mylan Pharmaceuticals Inc. POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 236; 2.97; 6.74; 5.86; 22.74 g/4L; g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0378-6688_6bb6fbae-c86a-476a-b1d2-a4faeee76840 0378-6688 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA090970 Mylan Pharmaceuticals Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0378-6689_6bb6fbae-c86a-476a-b1d2-a4faeee76840 0378-6689 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA090970 Mylan Pharmaceuticals Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0378-6709_fa0c7441-58de-4ba5-8342-844a27291dde 0378-6709 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium rabeprazole TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA076885 Mylan Pharmaceuticals Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0378-6725_53f323be-a948-4547-8cef-d7519febfaa2 0378-6725 HUMAN PRESCRIPTION DRUG Zonisamide zonisamide CAPSULE ORAL 20121022 ANDA ANDA077637 Mylan Pharmaceuticals Inc. ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-6726_53f323be-a948-4547-8cef-d7519febfaa2 0378-6726 HUMAN PRESCRIPTION DRUG Zonisamide zonisamide CAPSULE ORAL 20121022 ANDA ANDA077637 Mylan Pharmaceuticals Inc. ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-6727_53f323be-a948-4547-8cef-d7519febfaa2 0378-6727 HUMAN PRESCRIPTION DRUG Zonisamide zonisamide CAPSULE ORAL 20121022 ANDA ANDA077637 Mylan Pharmaceuticals Inc. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0378-6750_b57abbc4-b87a-4415-9603-1e30f80bb945 0378-6750 HUMAN PRESCRIPTION DRUG Balsalazide Disodium balsalazide disodium CAPSULE ORAL 20071228 ANDA ANDA077807 Mylan Pharmaceuticals Inc. BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 0378-6805_d5c8b3cc-00e8-4157-8084-01097156696b 0378-6805 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20080606 ANDA ANDA077238 Mylan Pharmaceuticals Inc. ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 0378-6810_d5c8b3cc-00e8-4157-8084-01097156696b 0378-6810 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20080606 ANDA ANDA077238 Mylan Pharmaceuticals Inc. ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 0378-6895_5686245b-690e-4475-a707-37bbbf624a23 0378-6895 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride amlodipine and benazepril hydrochloride CAPSULE ORAL 20120220 ANDA ANDA077375 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0378-6896_5686245b-690e-4475-a707-37bbbf624a23 0378-6896 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride amlodipine and benazepril hydrochloride CAPSULE ORAL 20120220 ANDA ANDA077375 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0378-6897_5686245b-690e-4475-a707-37bbbf624a23 0378-6897 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride amlodipine benazepril hydrochloride CAPSULE ORAL 20120220 ANDA ANDA077375 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0378-6898_5686245b-690e-4475-a707-37bbbf624a23 0378-6898 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride amlodipine and benazepril hydrochloride CAPSULE ORAL 20120220 ANDA ANDA077375 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0378-6899_5686245b-690e-4475-a707-37bbbf624a23 0378-6899 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride amlodipine and benazepril hydrochloride CAPSULE ORAL 20120220 ANDA ANDA079047 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0378-6900_5686245b-690e-4475-a707-37bbbf624a23 0378-6900 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride amlodipine and benazepril hydrochloride CAPSULE ORAL 20120220 ANDA ANDA079047 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0378-6905_12759023-2473-42ed-a00f-e6268e64b9f4 0378-6905 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET, CHEWABLE ORAL 20090126 ANDA ANDA076630 Mylan Pharmaceuticals Inc. LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0378-6925_12759023-2473-42ed-a00f-e6268e64b9f4 0378-6925 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET, CHEWABLE ORAL 20090126 ANDA ANDA076630 Mylan Pharmaceuticals Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0378-6988_0dac8080-e0e5-428c-a25e-c03eeac02307 0378-6988 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate ipratropium bromide and albuterol sulfate SOLUTION RESPIRATORY (INHALATION) 20010321 NDA NDA020950 Mylan Pharmaceuticals Inc. ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 3; .5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0378-6991_3ea432d0-7e24-4c65-ac6d-909cf90dee65 0378-6991 HUMAN PRESCRIPTION DRUG Albuterol Sulfate albuterol sulfate SOLUTION RESPIRATORY (INHALATION) 20091030 NDA NDA020949 Mylan Pharmaceuticals Inc. ALBUTEROL SULFATE .75 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0378-6992_3ea432d0-7e24-4c65-ac6d-909cf90dee65 0378-6992 HUMAN PRESCRIPTION DRUG Albuterol Sulfate albuterol sulfate SOLUTION RESPIRATORY (INHALATION) 20091030 NDA NDA020949 Mylan Pharmaceuticals Inc. ALBUTEROL SULFATE 1.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0378-6993_79e3a468-8b44-46db-ae14-9f6b67d4d799 0378-6993 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20090828 ANDA ANDA078309 Mylan Pharmaceuticals Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/.5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0378-7001_15c588b6-33f1-43ef-ad44-f2748d49650f 0378-7001 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20080324 ANDA ANDA078902 Mylan Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-7002_15c588b6-33f1-43ef-ad44-f2748d49650f 0378-7002 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20080324 ANDA ANDA078902 Mylan Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-7003_15c588b6-33f1-43ef-ad44-f2748d49650f 0378-7003 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20080324 ANDA ANDA078902 Mylan Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-7004_15c588b6-33f1-43ef-ad44-f2748d49650f 0378-7004 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20080324 ANDA ANDA078902 Mylan Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-7005_72b18ba5-dd3a-4aeb-9858-a97f5944e28c 0378-7005 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20041103 ANDA ANDA076762 Mylan Pharmaceuticals Inc. LOXAPINE SUCCINATE 5 mg/1 0378-7010_72b18ba5-dd3a-4aeb-9858-a97f5944e28c 0378-7010 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20041103 ANDA ANDA076762 Mylan Pharmaceuticals Inc. LOXAPINE SUCCINATE 10 mg/1 0378-7017_31690a1f-2b6f-40e7-9fc7-3c79b0f8450b 0378-7017 HUMAN PRESCRIPTION DRUG Bicalutamide bicalutamide TABLET, FILM COATED ORAL 20090706 ANDA ANDA079185 Mylan Pharmaceuticals Inc BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 0378-7025_72b18ba5-dd3a-4aeb-9858-a97f5944e28c 0378-7025 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20041103 ANDA ANDA076762 Mylan Pharmaceuticals Inc. LOXAPINE SUCCINATE 25 mg/1 0378-7050_72b18ba5-dd3a-4aeb-9858-a97f5944e28c 0378-7050 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20041103 ANDA ANDA076762 Mylan Pharmaceuticals Inc. LOXAPINE SUCCINATE 50 mg/1 0378-7096_7da3214d-3cbd-44b4-bcec-7126737f4560 0378-7096 HUMAN PRESCRIPTION DRUG Bromocriptine Mesylate bromocriptine mesylate CAPSULE ORAL 20130617 ANDA ANDA077226 Mylan Pharmaceuticals Inc. BROMOCRIPTINE MESYLATE 5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 0378-7097_a8242369-6fa8-4bb7-a616-351670206e5f 0378-7097 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075817 Mylan Pharmaceuticals Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0378-7098_a8242369-6fa8-4bb7-a616-351670206e5f 0378-7098 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075817 Mylan Pharmaceuticals Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0378-7100_dc07c6f1-42aa-40b8-8bda-1da3fcf6e08d 0378-7100 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20091222 ANDA ANDA076520 Mylan Pharmaceuticals Inc. FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0378-7101_dc07c6f1-42aa-40b8-8bda-1da3fcf6e08d 0378-7101 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20091222 ANDA ANDA076520 Mylan Pharmaceuticals Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0378-7103_6b66d0bc-d03c-4205-8fd0-04f0f0729245 0378-7103 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Mylan Pharmaceuticals Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 2.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-7104_6b66d0bc-d03c-4205-8fd0-04f0f0729245 0378-7104 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Mylan Pharmaceuticals Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-7105_6b66d0bc-d03c-4205-8fd0-04f0f0729245 0378-7105 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Mylan Pharmaceuticals Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-7106_6b66d0bc-d03c-4205-8fd0-04f0f0729245 0378-7106 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Mylan Pharmaceuticals Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-7109_2c775d64-f255-4a60-802c-40f1cd60d52c 0378-7109 HUMAN PRESCRIPTION DRUG Bromfenac Bromfenac sodium SOLUTION/ DROPS OPHTHALMIC 20110511 ANDA ANDA201211 Mylan Pharmaceuticals, Inc. BROMFENAC SODIUM .9 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-7110_2c775d64-f255-4a60-802c-40f1cd60d52c 0378-7110 HUMAN PRESCRIPTION DRUG Bromfenac Bromfenac sodium SOLUTION/ DROPS OPHTHALMIC 20110511 ANDA ANDA201211 Mylan Pharmaceuticals, Inc. BROMFENAC SODIUM .9 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-7111_2c775d64-f255-4a60-802c-40f1cd60d52c 0378-7111 HUMAN PRESCRIPTION DRUG Bromfenac Bromfenac sodium SOLUTION/ DROPS OPHTHALMIC 20110511 ANDA ANDA201211 Mylan Pharmaceuticals, Inc. BROMFENAC SODIUM .9 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-7155_a5c63bee-ad0a-4140-ba53-9d7383b41e36 0378-7155 HUMAN PRESCRIPTION DRUG Budesonide budesonide CAPSULE ORAL 20130823 ANDA ANDA090410 Mylan Pharmaceuticals Inc. BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0378-7180_9b471bcf-06f6-4011-8907-5e647065d467 0378-7180 HUMAN PRESCRIPTION DRUG Quinine Sulfate quinine sulfate CAPSULE ORAL 20121214 ANDA ANDA202581 Mylan Pharmaceuticals Inc. QUININE SULFATE 324 mg/1 Antimalarial [EPC] 0378-7185_1116d85b-f6e2-4f84-845a-f5ee7e12b27c 0378-7185 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20120919 ANDA ANDA075973 Mylan Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0378-7186_1116d85b-f6e2-4f84-845a-f5ee7e12b27c 0378-7186 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20120919 ANDA ANDA075973 Mylan Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0378-7187_1116d85b-f6e2-4f84-845a-f5ee7e12b27c 0378-7187 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20120919 ANDA ANDA075973 Mylan Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0378-7272_367119bf-2453-4d6b-8c4c-9be00dedb989 0378-7272 HUMAN PRESCRIPTION DRUG Norethindrone Norethindrone TABLET ORAL 20130624 ANDA ANDA200980 Mylan Pharmaceuticals Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0378-7280_19023703-4e79-43e7-84e9-7d27426a0641 0378-7280 HUMAN PRESCRIPTION DRUG NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL norethindrone acetate and ethinyl estradiol TABLET ORAL 20140711 ANDA ANDA202771 Mylan Pharmaceuticals Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE .02; 1 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0378-7283_86dc08c7-db51-4f97-85e5-92e925511be1 0378-7283 HUMAN PRESCRIPTION DRUG NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL norethindrone acetate and ethinyl estradiol KIT 20140716 ANDA ANDA202772 Mylan Pharmaceuticals Inc. 0378-7287_eb320501-d78c-4858-82aa-66d89f9bbd10 0378-7287 HUMAN PRESCRIPTION DRUG LEVONORGESTREL AND ETHINYL ESTRADIOL Levonorgestrel and Ethinyl Estradiol KIT 20140626 ANDA ANDA200245 Mylan Pharmaceuticals Inc. 0378-7292_60a13d29-ae6d-48f9-83b3-b686f61d11c9 0378-7292 HUMAN PRESCRIPTION DRUG Norethindrone Norethindrone TABLET ORAL 20130712 ANDA ANDA201483 Mylan Pharmaceuticals Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0378-7296_4986833e-cbac-484e-ae47-5dd177ba3929 0378-7296 HUMAN PRESCRIPTION DRUG DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL desogestrel and ethinyl estradiol and ethinyl estradiol KIT 20140716 ANDA ANDA202296 Mylan Pharmaceuticals Inc. 0378-7301_40239077-d5fb-46d5-967d-9caf937cebcd 0378-7301 HUMAN PRESCRIPTION DRUG NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL norethindrone acetate and ethinyl estradiol KIT 20141030 ANDA ANDA202742 Mylan Pharmaceuticals Inc. 0378-7350_143eaf52-603e-4fbd-8c9e-53fa22c60ef4 0378-7350 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20140624 ANDA ANDA202395 Mylan Pharmaceuticals Inc. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 0378-7351_143eaf52-603e-4fbd-8c9e-53fa22c60ef4 0378-7351 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20140624 ANDA ANDA202395 Mylan Pharmaceuticals Inc. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 0378-7352_143eaf52-603e-4fbd-8c9e-53fa22c60ef4 0378-7352 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20140624 ANDA ANDA202395 Mylan Pharmaceuticals Inc. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 0378-7353_143eaf52-603e-4fbd-8c9e-53fa22c60ef4 0378-7353 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20140624 ANDA ANDA202395 Mylan Pharmaceuticals Inc. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 0378-7732_3aa42303-119c-4015-8d1f-c1ac93e8d770 0378-7732 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20120910 ANDA ANDA078139 Mylan Pharmaceuticals Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0378-7734_3aa42303-119c-4015-8d1f-c1ac93e8d770 0378-7734 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20120910 ANDA ANDA078139 Mylan Pharmaceuticals Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0378-7970_041ea50d-a1ff-422a-af3a-fff0e2a483c5 0378-7970 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20101109 ANDA ANDA075693 Mylan Pharmaceuticals, Inc. IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0378-8008_7447d698-2100-4847-889a-f763d4b9bd62 0378-8008 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium CAPSULE, DELAYED RELEASE ORAL 20130507 ANDA ANDA090407 Mylan Pharmaceuticals Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0378-8011_0be95b09-902b-4cc5-9929-027c01421d0f 0378-8011 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline TABLET, FILM COATED ORAL 20130218 ANDA ANDA078626 Mylan Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-8015_6065e4e0-5302-4ebc-99e1-d01d86b6efc3 0378-8015 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20091110 ANDA ANDA090763 Mylan Pharmaceuticals Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0378-8020_7f4945a8-b0a0-41ec-984c-e2a34812bb8b 0378-8020 HUMAN PRESCRIPTION DRUG Fluvastatin Sodium fluvastatin CAPSULE ORAL 20130319 ANDA ANDA090595 Mylan Pharmaceuticals Inc. FLUVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-8021_7f4945a8-b0a0-41ec-984c-e2a34812bb8b 0378-8021 HUMAN PRESCRIPTION DRUG Fluvastatin Sodium fluvastatin CAPSULE ORAL 20130319 ANDA ANDA090595 Mylan Pharmaceuticals Inc. FLUVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0378-8030_6065e4e0-5302-4ebc-99e1-d01d86b6efc3 0378-8030 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20091110 ANDA ANDA090763 Mylan Pharmaceuticals Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0378-8088_b26c0378-5e2c-4e6c-b602-5a766a187b04 0378-8088 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen tramadol hydrochloride and acetaminophen TABLET, FILM COATED ORAL 20081124 ANDA ANDA077858 Mylan Pharmaceuticals Inc. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 0378-8105_00bed219-4b1f-4ec0-bfc4-87b6f855f853 0378-8105 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20080829 ANDA ANDA090900 Mylan Pharmaceuticals Inc. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0378-8106_00bed219-4b1f-4ec0-bfc4-87b6f855f853 0378-8106 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20080829 ANDA ANDA090900 Mylan Pharmaceuticals Inc. GALANTAMINE HYDROBROMIDE 16 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0378-8107_00bed219-4b1f-4ec0-bfc4-87b6f855f853 0378-8107 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20080829 ANDA ANDA090900 Mylan Pharmaceuticals Inc. GALANTAMINE HYDROBROMIDE 24 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0378-8115_0b538f5e-0fad-4d74-bab7-0b1531825c43 0378-8115 HUMAN PRESCRIPTION DRUG Methamphetamine Hydrochloride Methamphetamine Hydrochloride TABLET ORAL 20100426 ANDA ANDA091189 Mylan Pharmaceuticals Inc. METHAMPHETAMINE HYDROCHLORIDE 5 mg/1 Amphetamine Anorectic [EPC],Amphetamines [Chemical/Ingredient],Appetite Suppression [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE] CII 0378-8121_0be95b09-902b-4cc5-9929-027c01421d0f 0378-8121 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline TABLET, FILM COATED ORAL 20130218 ANDA ANDA078626 Mylan Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-8127_0be95b09-902b-4cc5-9929-027c01421d0f 0378-8127 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline TABLET, FILM COATED ORAL 20130218 ANDA ANDA078626 Mylan Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0378-8170_d3ae47c9-893c-41b8-b2a0-38f5fb3c1a31 0378-8170 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE, LIQUID FILLED ORAL 20111101 ANDA ANDA078501 Mylan Pharmaceuticals Inc. DRONABINOL 2.5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 0378-8171_d3ae47c9-893c-41b8-b2a0-38f5fb3c1a31 0378-8171 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE, LIQUID FILLED ORAL 20111101 ANDA ANDA078501 Mylan Pharmaceuticals Inc. DRONABINOL 5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 0378-8172_d3ae47c9-893c-41b8-b2a0-38f5fb3c1a31 0378-8172 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE, LIQUID FILLED ORAL 20111101 ANDA ANDA078501 Mylan Pharmaceuticals Inc. DRONABINOL 10 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 0378-8200_25f9c2db-5d57-46b7-8cd5-38310bd1ed40 0378-8200 HUMAN PRESCRIPTION DRUG Ketoprofen ketoprofen CAPSULE, EXTENDED RELEASE ORAL 20030904 ANDA ANDA075679 Mylan Pharmaceuticals Inc. KETOPROFEN 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0378-8270_e4a10741-a10f-4d9f-a98c-c8c168cf433a 0378-8270 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20121015 ANDA ANDA077839 Mylan Pharmaceuticals, Inc. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0378-8301_4a535af2-16fc-4fdf-92ec-7941ef23a63a 0378-8301 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa and Entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20131028 NDA AUTHORIZED GENERIC NDA021485 Mylan Pharmaceuticals Inc. CARBIDOPA; ENTACAPONE; LEVODOPA 18.75; 200; 75 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0378-8302_4a535af2-16fc-4fdf-92ec-7941ef23a63a 0378-8302 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa and Entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20131028 NDA AUTHORIZED GENERIC NDA021485 Mylan Pharmaceuticals Inc. CARBIDOPA; ENTACAPONE; LEVODOPA 25; 200; 100 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0378-8303_4a535af2-16fc-4fdf-92ec-7941ef23a63a 0378-8303 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa and Entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20131028 NDA AUTHORIZED GENERIC NDA021485 Mylan Pharmaceuticals Inc. CARBIDOPA; ENTACAPONE; LEVODOPA 31.25; 200; 125 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0378-8304_4a535af2-16fc-4fdf-92ec-7941ef23a63a 0378-8304 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa and Entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20131028 NDA AUTHORIZED GENERIC NDA021485 Mylan Pharmaceuticals Inc. CARBIDOPA; ENTACAPONE; LEVODOPA 37.5; 200; 150 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0378-8305_4a535af2-16fc-4fdf-92ec-7941ef23a63a 0378-8305 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa and Entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20131028 NDA AUTHORIZED GENERIC NDA021485 Mylan Pharmaceuticals Inc. CARBIDOPA; ENTACAPONE; LEVODOPA 50; 200; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0378-8628_6b18628e-998d-42e2-9c11-71c8ad04c6e2 0378-8628 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20121101 ANDA ANDA202676 Mylan Pharmaceuticals Inc. FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0378-8629_6b18628e-998d-42e2-9c11-71c8ad04c6e2 0378-8629 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20121101 ANDA ANDA202676 Mylan Pharmaceuticals Inc. FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0378-8630_6b18628e-998d-42e2-9c11-71c8ad04c6e2 0378-8630 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20121101 ANDA ANDA202676 Mylan Pharmaceuticals Inc. FENOFIBRATE 200 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0378-8688_b5263478-a3b9-42df-b11d-caf20e83e5b0 0378-8688 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate and Benzoyl Peroxide clindamycin phosphate and benzoyl peroxide KIT 20090825 ANDA ANDA065443 Mylan Pharmaceuticals Inc. 0378-8700_ab3c9c7e-1bda-4579-9b90-2133c99c95a8 0378-8700 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir OINTMENT TOPICAL 20130403 ANDA ANDA202459 Mylan Pharmaceuticals Inc. ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0378-8880_e01a3ec3-2000-4180-b929-6b5c40946570 0378-8880 HUMAN OTC DRUG Loratadine loratadine TABLET ORAL 20130327 ANDA ANDA076154 Mylan Pharmaceuticals Inc. LORATADINE 10 mg/1 0378-8886_10bf39de-3320-46f1-9dad-d87c99f2878a 0378-8886 HUMAN PRESCRIPTION DRUG Didanosine didanosine enteric-coated beadlets CAPSULE, DELAYED RELEASE ORAL 20100628 ANDA ANDA090788 Mylan Pharmaceuticals Inc. DIDANOSINE 125 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0378-8887_10bf39de-3320-46f1-9dad-d87c99f2878a 0378-8887 HUMAN PRESCRIPTION DRUG Didanosine didanosine enteric-coated beadlets CAPSULE, DELAYED RELEASE ORAL 20100628 ANDA ANDA090788 Mylan Pharmaceuticals Inc. DIDANOSINE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0378-8888_10bf39de-3320-46f1-9dad-d87c99f2878a 0378-8888 HUMAN PRESCRIPTION DRUG Didanosine didanosine enteric-coated beadlets CAPSULE, DELAYED RELEASE ORAL 20100628 ANDA ANDA090788 Mylan Pharmaceuticals Inc. DIDANOSINE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0378-8889_10bf39de-3320-46f1-9dad-d87c99f2878a 0378-8889 HUMAN PRESCRIPTION DRUG Didanosine didanosine enteric-coated beadlets CAPSULE, DELAYED RELEASE ORAL 20100628 ANDA ANDA090788 Mylan Pharmaceuticals Inc. DIDANOSINE 400 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0378-9040_3aab3b39-52b6-4a79-9a5c-7baa7574f24f 0378-9040 HUMAN PRESCRIPTION DRUG Cystagon cysteamine bitartrate CAPSULE ORAL 19940815 NDA NDA020392 Mylan Pharmaceuticals Inc. CYSTEAMINE BITARTRATE 50 mg/1 Cystine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA] 0378-9045_3aab3b39-52b6-4a79-9a5c-7baa7574f24f 0378-9045 HUMAN PRESCRIPTION DRUG Cystagon cysteamine bitartrate CAPSULE ORAL 19940815 NDA NDA020392 Mylan Pharmaceuticals Inc. CYSTEAMINE BITARTRATE 150 mg/1 Cystine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA] 0378-9080_e41bbc90-bb83-4514-a38f-994e9fa76472 0378-9080 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20130626 NDA AUTHORIZED GENERIC NDA020796 Mylan Pharmaceuticals Inc. ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0378-9102_132b3818-681a-4369-b606-b95b0f2486c6 0378-9102 HUMAN PRESCRIPTION DRUG Nitroglycerin nitroglycerin PATCH TRANSDERMAL 20110919 ANDA ANDA074559 Mylan Pharmaceuticals Inc. NITROGLYCERIN .1 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0378-9104_132b3818-681a-4369-b606-b95b0f2486c6 0378-9104 HUMAN PRESCRIPTION DRUG Nitroglycerin nitroglycerin PATCH TRANSDERMAL 20110919 ANDA ANDA074559 Mylan Pharmaceuticals Inc. NITROGLYCERIN .2 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0378-9112_132b3818-681a-4369-b606-b95b0f2486c6 0378-9112 HUMAN PRESCRIPTION DRUG Nitroglycerin nitroglycerin PATCH TRANSDERMAL 20110919 ANDA ANDA074559 Mylan Pharmaceuticals Inc. NITROGLYCERIN .4 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0378-9116_132b3818-681a-4369-b606-b95b0f2486c6 0378-9116 HUMAN PRESCRIPTION DRUG Nitroglycerin nitroglycerin PATCH TRANSDERMAL 20110919 ANDA ANDA074559 Mylan Pharmaceuticals Inc. NITROGLYCERIN .6 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0378-9119_fa2f94b0-2935-48ed-b5b3-061eadc28085 0378-9119 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH TRANSDERMAL 20070124 ANDA ANDA076258 Mylan Pharmaceuticals Inc. FENTANYL 12 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-9121_fa2f94b0-2935-48ed-b5b3-061eadc28085 0378-9121 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH TRANSDERMAL 20050128 ANDA ANDA076258 Mylan Pharmaceuticals Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-9122_fa2f94b0-2935-48ed-b5b3-061eadc28085 0378-9122 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH TRANSDERMAL 20050128 ANDA ANDA076258 Mylan Pharmaceuticals Inc. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-9123_fa2f94b0-2935-48ed-b5b3-061eadc28085 0378-9123 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH TRANSDERMAL 20050128 ANDA ANDA076258 Mylan Pharmaceuticals Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-9124_fa2f94b0-2935-48ed-b5b3-061eadc28085 0378-9124 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH TRANSDERMAL 20050128 ANDA ANDA076258 Mylan Pharmaceuticals Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0378-9290_d3af20f6-39ab-4cfd-b24b-b83f7692645c 0378-9290 HUMAN PRESCRIPTION DRUG Selegiline Hydrochloride selegiline hydrochloride TABLET ORAL 20100308 ANDA ANDA074866 Mylan Pharmaceuticals Inc. SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] 0378-9639_60aed62b-dabe-4abb-b8dc-06b92721addd 0378-9639 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate butorphanol tartrate SPRAY NASAL 20110121 ANDA ANDA075759 Mylan Pharmaceuticals Inc. BUTORPHANOL TARTRATE 10 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV 0378-9645_1c0c4998-100a-429a-a1c0-e7e96b2e7700 0378-9645 HUMAN PRESCRIPTION DRUG Latanoprost latanoprost SOLUTION OPHTHALMIC 20110322 ANDA ANDA201786 Mylan Pharmaceuticals Inc. LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 0378-9671_abd4d46c-324c-49b7-86fd-00fe38286a49 0378-9671 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20130301 ANDA ANDA202496 Mylan Pharmaceuticals, Inc. ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 3; .5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0378-9680_82db1a78-16f1-4770-a346-f15bde5c874d 0378-9680 HUMAN PRESCRIPTION DRUG Levalbuterol levalbuterol SOLUTION RESPIRATORY (INHALATION) 20130315 ANDA ANDA077800 Mylan Pharmaceuticals Inc. LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0378-9681_82db1a78-16f1-4770-a346-f15bde5c874d 0378-9681 HUMAN PRESCRIPTION DRUG Levalbuterol levalbuterol SOLUTION RESPIRATORY (INHALATION) 20130315 ANDA ANDA077800 Mylan Pharmaceuticals Inc. LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0378-9682_82db1a78-16f1-4770-a346-f15bde5c874d 0378-9682 HUMAN PRESCRIPTION DRUG Levalbuterol levalbuterol SOLUTION RESPIRATORY (INHALATION) 20130315 ANDA ANDA077800 Mylan Pharmaceuticals Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0389-0173_6f8fbf99-dcdd-4167-9d10-1c0463a7f240 0389-0173 HUMAN PRESCRIPTION DRUG Magnesium Chloride Magnesium Chloride INJECTION, SOLUTION INTRAVENOUS 19900903 UNAPPROVED DRUG OTHER The Torrance Company MAGNESIUM CHLORIDE 200 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0389-0486_72133842-ac3f-4a39-a825-38e01930a0a7 0389-0486 HUMAN PRESCRIPTION DRUG Ascorbic Acid Ascorbic Acid INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19990601 UNAPPROVED DRUG OTHER The Torrance Company ASCORBIC ACID 500 mg/mL 0395-0055_7ea39269-0ed8-4926-9eb9-dd43689e5820 0395-0055 HUMAN OTC DRUG Humco Aluminum Acetate (Burrow) Aluminum Acetate LIQUID TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Humco Holding Group, Inc. ALUMINUM ACETATE 530 mg/mL 0395-0073_9c72e3ba-d089-46e3-a555-273b220b2fac 0395-0073 HUMAN OTC DRUG Humco Aromatic Ammonia Spirit Ammonia 2% LIQUID TOPICAL 20080101 UNAPPROVED DRUG OTHER Humco Holding Group, Inc. AMMONIA 20 mg/mL 0395-0119_c8e0d2bb-1717-46d5-a068-f0b4d7b24098 0395-0119 HUMAN OTC DRUG Ivy Wash Pramoxine Hydrochloride LOTION TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part348 Humco Holding Group, Inc. PRAMOXINE HYDROCHLORIDE 10 1/mL 0395-0243_2864b3e8-6abc-45c8-bbcb-b6b7de60db38 0395-0243 HUMAN OTC DRUG Benzoin Compound Tincture Benzoin Resin LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part356 Humco Holding Group, Inc. BENZOIN RESIN 1000 mg/mL 0395-0247_4b4fa6b0-c3f4-4bdc-a13b-3e591788c21d 0395-0247 HUMAN OTC DRUG Benzoin Tincture Benzoin Resin LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part356 Humco Holding Group, Inc. BENZOIN RESIN 1000 mg/mL 0395-0400_7ad170b1-06a0-4e0c-a36f-e17b2e5d2c0a 0395-0400 HUMAN OTC DRUG Humco Calagesic Zinc Acetate and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Humco Holding Group, Inc. PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 10; 80 mg/mL; mg/mL 0395-0407_d0b487b9-a70e-49da-a44f-b172736f46bb 0395-0407 HUMAN OTC DRUG Calamine Phenolated Topical Suspension Calamine and Zinc Oxide and Phenol LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Humco Holding Group, Inc PHENOL; ZINC OXIDE 10; 160 mg/mL; mg/mL 0395-0413_1a4731e6-9a26-4e31-a9f7-bb18dffe9c75 0395-0413 HUMAN OTC DRUG Humco Calamine Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Humco holding Group, Inc. ZINC OXIDE 160 mg/mL 0395-0420_1f83d8cd-91f0-497b-b495-6be06db92b1b 0395-0420 HUMAN OTC DRUG Humco Calagesic Calamine and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Humco Holding Group, Inc. PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 10; 80 mg/mL; mg/mL 0395-0431_5b216b27-07a8-4f7f-8d2c-f2afc69739a0 0395-0431 HUMAN OTC DRUG Calcium Carbonate Calcium Carbonate POWDER ORAL 20080101 OTC MONOGRAPH FINAL part331 Humco Holding Group, Inc. CALCIUM CARBONATE 1 g/g 0395-0467_53777b04-3f17-4aee-95e7-3bef206150cb 0395-0467 HUMAN OTC DRUG HUMCO Camphor Spirit Camphor 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part348 Humco Holding Group, Inc. CAMPHOR (NATURAL) 100 mg/mL 0395-0515_5610858a-81b7-4f3d-89af-67e94647bc6c 0395-0515 HUMAN OTC DRUG Humco Castor Oil Castor Oil LIQUID ORAL 20080101 OTC MONOGRAPH NOT FINAL part334 Humco holding Group, Inc CASTOR OIL 1 mg/mL 0395-0527_14eaf283-2ab2-4f9f-8a77-111c0854aad1 0395-0527 HUMAN OTC DRUG Humco Charcoal Activated Activated Charcoal POWDER ORAL 20080101 UNAPPROVED DRUG OTHER Humco Holding Group. Inc. ACTIVATED CHARCOAL 1000 mg/g 0395-0713_504409ef-412b-40a4-b3a6-49fa4aacf239 0395-0713 HUMAN OTC DRUG Humco Dewees Carminative Magnesium Carbonate SUSPENSION ORAL 19980325 OTC MONOGRAPH FINAL part331 Humco Holding Group, inc. MAGNESIUM CARBONATE 50 mg/mL 0395-0807_d37aa0dd-dbe7-43be-abf5-2232374e8e52 0395-0807 HUMAN OTC DRUG Humco Epson Salt Magnesium Sulfate POWDER, FOR SOLUTION ORAL 19980325 OTC MONOGRAPH NOT FINAL part334 humco Holding Group, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 1000 mg/g 0395-1003_a333c3a5-639e-4597-97f6-d584cb05a35f 0395-1003 HUMAN OTC DRUG Humco Gentian Violet 1% Gentian Violet 1% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Humco holding Group, Inc. GENTIAN VIOLET 10 mg/mL 0395-1005_fb0ab4ac-9b12-4f14-8f1a-b077d7910fd1 0395-1005 HUMAN OTC DRUG Humco Gentian Violet 2% Gentian Violet 2% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. GENTIAN VIOLET 20 mg/mL 0395-1037_f0633de1-4a6e-478d-8af3-a2ecbacccf20 0395-1037 HUMAN OTC DRUG Humco Glycerin and Artificial Rose Water Glycerin LIQUID TOPICAL 19980325 OTC MONOGRAPH FINAL part346 Humco Holding Gruop, Inc. GLYCERIN 100 mg/mL 0395-1113_40b2fb26-99e2-4407-8978-0a67a36d6fb4 0395-1113 HUMAN OTC DRUG Humco Hydrogen Peroxide Hydrogen Peroxide 3% LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. HYDROGEN PEROXIDE 30 mg/mL 0395-1207_8c11ecae-63d2-4b9f-a659-5419a2d7a1de 0395-1207 HUMAN OTC DRUG GNP Iodides Tincture Ethyl Alcohol LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. ALCOHOL .45 mL/mL 0395-1213_2914725b-5cd9-42bc-8bd1-f8774ec42a7c 0395-1213 HUMAN OTC DRUG Iodine Tincture Mild Iodine and Sodium Iodide and Alcohol LIQUID TOPICAL 19790101 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc ALCOHOL; IODINE; SODIUM IODIDE 470; 20; 20.4 mg/mL; mg/mL; mg/mL 0395-1219_1d670f05-c638-4ca4-a9c5-dad31f394eaa 0395-1219 HUMAN OTC DRUG Humco Strong Iodine Tincture Iodine Tincture LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A Humo Holding Group, inc. ALCOHOL; IODINE; POTASSIUM IODIDE 850; 70; 50 mg/mL; mg/mL; mg/mL 0395-1249_abda6e61-4af1-423b-8e3e-be7b31f9b874 0395-1249 HUMAN OTC DRUG HUMCO Isopropyl Rubbing Alcohol 70% Isopropyl Alcohol LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. ISOPROPYL ALCOHOL 700 mg/mL 0395-1637_f4045a51-7641-4a8b-94ee-28c031376acb 0395-1637 HUMAN OTC DRUG HUMCO Mercuroclear Benzalkonium Chloride and Lidocaine Hydrochloride LIQUID TOPICAL 19990225 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 25 mg/mL; mg/mL 0395-1667_89f043d9-c489-46a7-904a-40b7216ab3ba 0395-1667 HUMAN OTC DRUG Humco Wintergreen Oil Methyl Salicylate LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part348 Humco Holding Grou, Inc. METHYL SALICYLATE 980 mg/mL 0395-1670_a4fc66b2-b4bc-4362-b84d-67485697effe 0395-1670 HUMAN OTC DRUG Humco Milk of Magnesia Magnesium Hydroxide SUSPENSION ORAL 19980325 OTC MONOGRAPH FINAL part331 Humco Holding Group, Inc. MAGNESIUM HYDROXIDE 80 mg/mL 0395-1673_66eaca44-0fd1-4964-a526-74ce7ada9e15 0395-1673 HUMAN OTC DRUG Humco Mineral Oil Light Mineral Oil LIQUID TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Humco Holding Group, Inc. MINERAL OIL 1000 mg/mL 0395-1685_68626bd3-6f89-473b-a63d-7da592cdb6de 0395-1685 HUMAN OTC DRUG Humco Mineral Oil Heavy Mineral Oil LIQUID ORAL 19980325 OTC MONOGRAPH NOT FINAL part334 Humco Holding Group, Inc. MINERAL OIL 1000 mg/mL 0395-2075_aeddb109-a2ba-4c20-a04c-b67351846eac 0395-2075 HUMAN OTC DRUG Humco Turpentine Oil Rectified Turpentine LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part348 Humco Holding Group, Inc. TURPENTINE 1000 mg/mL 0395-2300_6d892175-6fe2-4af5-9fcc-aa40188054d2 0395-2300 HUMAN PRESCRIPTION DRUG HUMCO Potassium Chloride Oral Solution 10% Potassium Chloride Solution LIQUID ORAL 19790101 UNAPPROVED DRUG OTHER Humco Holding Group. Inc. POTASSIUM CHLORIDE 100 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0395-2325_d73cebdb-c967-4de0-a704-d651f31511c3 0395-2325 HUMAN OTC DRUG Humco Povidone Iodine Povidone Iodine 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. POVIDONE-IODINE 100 mg/mL 0395-2649_331e0137-3f83-4e69-a1df-640f56615696 0395-2649 HUMAN OTC DRUG Humco Senna Leaves Senna Leaves EXTRACT ORAL 19980325 OTC MONOGRAPH NOT FINAL part334 Humco Holding Group, Inc. SENNOSIDES A AND B 1000 mg/g 0395-2655_09bfdbba-aeb4-44e3-b755-3fa567a8750c 0395-2655 HUMAN OTC DRUG Humco Senna Powder Senna Powder POWDER ORAL 19980325 OTC MONOGRAPH NOT FINAL part334 Humco Holding Group, Inc. SENNOSIDES A AND B 1000 mg/g 0395-2685_901b3dc2-3985-49c8-b820-c5de2f3dd2a0 0395-2685 HUMAN OTC DRUG Humco Sodium Bicarbonate Sodium Bicarbonate POWDER ORAL 19980325 OTC MONOGRAPH FINAL part331 Humco Holding Group, Inc. SODIUM BICARBONATE 1000 mg/g 0395-2775_2635d9a0-2861-4e80-8266-70b898efdd9e 0395-2775 HUMAN PRESCRIPTION DRUG HUMCO Strong Iodine Solution Iodine and potassium iodide LIQUID ORAL 20080101 UNAPPROVED DRUG OTHER Humco Holding Group, Inc. IODINE; POTASSIUM IODIDE 50; 100 mg/mL; mg/mL 0395-4202_83208674-58b0-4fa3-bf0c-59c0bac7aa16 0395-4202 HUMAN OTC DRUG HUMCO Isopropyl Rubbing Alcohol 70% Professional Pack Isopropyl Alcohol LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. ISOPROPYL ALCOHOL 700 mg/mL 0395-4209_78a21fa3-22ef-4319-8025-0737f91c0462 0395-4209 HUMAN OTC DRUG Benzoin Compound Tincture Professional Pack Benzoin Resin LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part356 Humco Holding Group, Inc. BENZOIN RESIN 1000 mg/mL 0395-8010_5295d9eb-0fa8-47b7-915d-ca3dbc793ad7 0395-8010 HUMAN OTC DRUG HUMCO Merthiolate Benzalkonium Chloride LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc BENZALKONIUM CHLORIDE 1.3 mg/mL 0404-0001_50a584d2-109a-4fbd-9721-02c822029ecc 0404-0001 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Henry Schein Inc. HYDROGEN PEROXIDE 30 mg/mL 0404-0002_6493fdda-9388-4ed5-bf49-1a0b5d84faad 0404-0002 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Henry Schein Inc. ISOPROPYL ALCOHOL 700 mg/mL 0404-0042_3b0507f1-bf3e-4a43-b6a6-36a46f039228 0404-0042 HUMAN OTC DRUG Petrolatum petrolatum OINTMENT TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part347 Henry Schein, Inc. PETROLATUM 1 g/g 0404-0360_6d8ee872-bd48-43df-ba9d-e1569cb11dab 0404-0360 HUMAN OTC DRUG Schein Triple Antibiotic neomycin, polymixin, bacitracin OINTMENT TOPICAL 20110412 OTC MONOGRAPH FINAL part333B Henry Schein, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [iU]/g; mg/g; [iU]/g 0404-0370_66c7f737-55f2-49e1-965c-521af5c3ba90 0404-0370 HUMAN OTC DRUG Hydrocortisone hydrocortisone CREAM TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part348 Henry Schein, Inc. HYDROCORTISONE 10 mg/g 0404-0375_4d44cab8-31aa-40b6-ae49-bf8391da4aa4 0404-0375 HUMAN OTC DRUG A and D Petrolatum OINTMENT TOPICAL 20120514 OTC MONOGRAPH FINAL part347 Henry Schein, Inc. PETROLATUM 937.5 mg/g 0404-0400_807ecc1a-2c69-49a8-9634-3a5a6d39a06f 0404-0400 HUMAN OTC DRUG Ultra Seal Bacitracin BACITRACIN ZINC OINTMENT TOPICAL 20111204 OTC MONOGRAPH FINAL part333B Henry Schein, Inc. BACITRACIN ZINC 500 [iU]/g 0404-0703_ddf200c4-718e-4528-87cb-6f375858188a 0404-0703 HUMAN OTC DRUG Henry Schein Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20081230 ANDA ANDA075139 Henry Schein Inc. IBUPROFEN 200 mg/1 0404-0712_6531d233-63de-4308-8cf6-beaa7a1070e9 0404-0712 HUMAN OTC DRUG Henry Schein Aspirin Aspirin TABLET, FILM COATED ORAL 20110725 OTC MONOGRAPH FINAL part343 Henry Schein, Inc. ASPIRIN 325 mg/1 0404-0714_80a23cdf-063e-4db9-ae9d-1a2a6804a0bf 0404-0714 HUMAN OTC DRUG Henry Schein Acetaminophen Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Henry Schein, Inc. ACETAMINOPHEN 325 mg/1 0404-0716_baabf1ab-5551-42cb-9b06-3b0f1a5e32ce 0404-0716 HUMAN OTC DRUG Henry Schein Acetaminophen Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Henry Schein, Inc. ACETAMINOPHEN 500 mg/1 0404-0731_8cdaec7c-f5e2-4a4b-8d75-fa34e7ebae90 0404-0731 HUMAN PRESCRIPTION DRUG Benzo-Jel Banana Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Henry Schein, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0404-1000_845c2617-4795-4ba6-988b-8686a8ed942c 0404-1000 HUMAN PRESCRIPTION DRUG STYPTSTIX Silver Nitrate Applicator STICK TOPICAL 19490419 UNAPPROVED DRUG OTHER Henry Schein Inc. POTASSIUM NITRATE; SILVER NITRATE 12.74; 38.21 mg/1; mg/1 0404-1080_bac98ca9-ab1e-4867-9ef6-236642898675 0404-1080 HUMAN PRESCRIPTION DRUG Topical Hemo-Stat Aluminum Chloride SOLUTION DENTAL 19630219 UNAPPROVED DRUG OTHER Henry Schein ALUMINUM CHLORIDE 250 mg/g 0404-3416_75566fd9-461f-4f06-bb64-2ef6bca44f74 0404-3416 HUMAN PRESCRIPTION DRUG Benzo-Jel Raspberry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Henry Schein, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0404-4075_0829509a-1b9c-5d8a-e054-00144ff8d46c 0404-4075 HUMAN PRESCRIPTION DRUG Acclean Chlorhexidine Gluconate 0.12% Oral Rinse Chlorhexidine Gluconate 0.12% Oral Rinse LIQUID ORAL 20091001 ANDA ANDA077789 Henry Schein, Inc. CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] 0404-4438_8d0f604a-b9ef-4c01-85c3-5f7d6d93528e 0404-4438 HUMAN OTC DRUG Antibacterial Hand chloroxylenol SOAP TOPICAL 20130130 OTC MONOGRAPH NOT FINAL part333A Henry Schein, Inc. CHLOROXYLENOL 6.1 g/L 0404-4441_3fa3143c-d475-4094-b6d4-223580487e91 0404-4441 HUMAN OTC DRUG Antibacterial chloroxylenol LIQUID TOPICAL 20130131 OTC MONOGRAPH NOT FINAL part333A Henry Schein, Inc. CHLOROXYLENOL 6.046 g/L 0404-4445_1a133c7c-aba0-4011-8213-3d889737d502 0404-4445 HUMAN OTC DRUG Hand Sanitizer benzalkonium chloride LIQUID TOPICAL 20130130 OTC MONOGRAPH NOT FINAL part333E Henry Schein, Inc. BENZALKONIUM CHLORIDE 7.49 g/L 0404-5637_66e953a6-6da4-4aad-8758-4a020abaad56 0404-5637 HUMAN OTC DRUG povidine iodine povidine iodine SWAB TOPICAL 20110317 OTC MONOGRAPH FINAL part333C Henry Schein Inc POVIDONE-IODINE 10 mL/100mL 0404-5638_481480de-fc66-4fdf-9b12-76341d0e1974 0404-5638 HUMAN OTC DRUG povidine iodine povidine iodine SWAB TOPICAL 20110317 OTC MONOGRAPH FINAL part333C Henry Schein Inc POVIDONE-IODINE 10 mL/100mL 0404-5639_490c1272-43db-4fe6-88f7-27f83e75ea59 0404-5639 HUMAN OTC DRUG povidine iodine povidine iodine SWAB TOPICAL 20110317 OTC MONOGRAPH FINAL part333C Henry Schein Inc POVIDONE-IODINE 10 mL/100mL 0404-5824_47424e29-8f84-450e-9f13-89a130394660 0404-5824 HUMAN OTC DRUG BZK Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20111005 OTC MONOGRAPH NOT FINAL part333A Henry Schein Inc. BENZALKONIUM CHLORIDE .001 mL/1.4mL 0404-5987_0cded02c-7e59-456c-966d-fd1a24a86cbf 0404-5987 HUMAN OTC DRUG Antimicrobial Hand Wash Chloroxylenol SOAP TOPICAL 20120207 OTC MONOGRAPH NOT FINAL part333A Henry Schein, Inc. CHLOROXYLENOL 6 mL/1000mL 0404-5988_380f0f50-a4fe-44f5-b48f-b9879212fd22 0404-5988 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20120207 OTC MONOGRAPH NOT FINAL part333E Henry Schein, Inc. ALCOHOL 665 mL/1000mL 0404-5990_b5c90e2d-4f6a-4533-829e-233d2bcac71b 0404-5990 HUMAN OTC DRUG Antimicrobial Hand Wash Chloroxylenol SOAP TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333A Henry Schein, Inc. CHLOROXYLENOL 6 mL/1000mL 0404-5991_cdf7e25f-de59-4638-823f-119e20890f21 0404-5991 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Henry Schein, Inc. ALCOHOL 665 mL/1000mL 0404-6500_772e8c9f-b633-47d9-b5c9-2d39dc7e126a 0404-6500 HUMAN PRESCRIPTION DRUG LIDOCAINE Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088389 Henry Schein Inc. EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .02; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0404-6512_ddc1b6bd-a288-4ca1-8c33-605894430939 0404-6512 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088390 Henry Scein Inc EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0404-6620_7c568919-e848-4f65-b57a-25c006c5c05f 0404-6620 HUMAN PRESCRIPTION DRUG Articaine Hydrochloride and Epinephrine Bitartrate Articaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20100827 NDA NDA020971 Henry Schein Inc. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0404-6625_7c568919-e848-4f65-b57a-25c006c5c05f 0404-6625 HUMAN PRESCRIPTION DRUG Articaine Hydrochloride and Epinephrine Bitartrate Articaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20100827 NDA NDA020971 Henry Schein Inc. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0404-6720_08c9d3dd-717a-0148-e054-00144ff8d46c 0404-6720 HUMAN PRESCRIPTION DRUG Acclean Chlorhexidine Gluconate 0.12% Oral Rinse Chlorhexidine Gluconate 0.12% Oral Rinse LIQUID ORAL 20130201 ANDA ANDA077789 Henry Schein, Inc. CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] 0404-6735_c41742ae-2bb7-4014-9448-000665a033d4 0404-6735 HUMAN OTC DRUG BZK benzalkonium chloride LIQUID TOPICAL 20130107 OTC MONOGRAPH NOT FINAL part333E Henry Schein Inc. BENZALKONIUM CHLORIDE .0013 g/g 0404-6918_f7d139dc-8c9f-a925-0dc7-3249a02dd555 0404-6918 HUMAN PRESCRIPTION DRUG Acclean Plus Sodium Flouride GEL, DENTIFRICE ORAL 20140415 UNAPPROVED DRUG OTHER Henry Schein, Inc. SODIUM FLUORIDE 11 mg/g 0404-6919_f7d139dc-8c9f-a925-0dc7-3249a02dd555 0404-6919 HUMAN PRESCRIPTION DRUG Acclean Plus Sodium Flouride GEL, DENTIFRICE ORAL 20140415 UNAPPROVED DRUG OTHER Henry Schein, Inc. SODIUM FLUORIDE 11 mg/g 0404-8016_4b579b08-3519-42f2-92fc-110fda9ff281 0404-8016 HUMAN PRESCRIPTION DRUG Acclean Sodium Flouride GEL, DENTIFRICE ORAL 19970101 UNAPPROVED DRUG OTHER Henry Schein Inc. SODIUM FLUORIDE 5 mg/g 0406-0123_14387b9f-a79b-4391-ae16-46715e868dba 0406-0123 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20140901 ANDA ANDA040409 Mallinckrodt, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0406-0124_14387b9f-a79b-4391-ae16-46715e868dba 0406-0124 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20140901 ANDA ANDA040405 Mallinckrodt, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0406-0125_14387b9f-a79b-4391-ae16-46715e868dba 0406-0125 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20140901 ANDA ANDA040400 Mallinckrodt, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0406-0127_75d18744-d6d3-45b0-94d7-a00191543e86 0406-0127 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Extended-Release Methylphenidate Hydrochloride TABLET ORAL 20120630 ANDA ANDA202608 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-0136_75d18744-d6d3-45b0-94d7-a00191543e86 0406-0136 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Extended-Release Methylphenidate Hydrochloride TABLET ORAL 20120630 ANDA ANDA202608 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 36 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-0154_75d18744-d6d3-45b0-94d7-a00191543e86 0406-0154 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Extended-Release Methylphenidate Hydrochloride TABLET ORAL 20120630 ANDA ANDA202608 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 54 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-0357_14387b9f-a79b-4391-ae16-46715e868dba 0406-0357 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 20170930 ANDA ANDA089160 Mallinckrodt, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0406-0358_14387b9f-a79b-4391-ae16-46715e868dba 0406-0358 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 20180930 ANDA ANDA040201 Mallinckrodt, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0406-0359_14387b9f-a79b-4391-ae16-46715e868dba 0406-0359 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 20160630 ANDA ANDA089725 Mallinckrodt, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0406-0360_14387b9f-a79b-4391-ae16-46715e868dba 0406-0360 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 20160630 ANDA ANDA040084 Mallinckrodt, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0406-0361_14387b9f-a79b-4391-ae16-46715e868dba 0406-0361 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 20160831 ANDA ANDA040084 Mallinckrodt, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0406-0362_14387b9f-a79b-4391-ae16-46715e868dba 0406-0362 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 20160630 ANDA ANDA040084 Mallinckrodt, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 660; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0406-0363_14387b9f-a79b-4391-ae16-46715e868dba 0406-0363 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 20160930 ANDA ANDA040201 Mallinckrodt, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0406-0364_14387b9f-a79b-4391-ae16-46715e868dba 0406-0364 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 20150131 ANDA ANDA040468 Mallinckrodt, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0406-0365_14387b9f-a79b-4391-ae16-46715e868dba 0406-0365 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 20180730 ANDA ANDA040409 Mallinckrodt, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0406-0366_14387b9f-a79b-4391-ae16-46715e868dba 0406-0366 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 20170530 ANDA ANDA040405 Mallinckrodt, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0406-0367_14387b9f-a79b-4391-ae16-46715e868dba 0406-0367 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 20170730 ANDA ANDA040400 Mallinckrodt, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0406-0483_5e95638b-6a33-4071-8785-c931b2844fe2 0406-0483 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 Mallinckrodt, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0406-0484_5e95638b-6a33-4071-8785-c931b2844fe2 0406-0484 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 Mallinckrodt, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0406-0485_5e95638b-6a33-4071-8785-c931b2844fe2 0406-0485 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 Mallinckrodt, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0406-0512_a3461494-5959-4082-ab97-61f1c49fe5c7 0406-0512 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20110308 ANDA ANDA087463 Mallinckrodt, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-0522_a3461494-5959-4082-ab97-61f1c49fe5c7 0406-0522 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20110308 ANDA ANDA040545 Mallinckrodt, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-0523_a3461494-5959-4082-ab97-61f1c49fe5c7 0406-0523 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20110308 ANDA ANDA040545 Mallinckrodt, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-0527_a6c32b30-06b9-4ea3-9e12-f6b4e0130148 0406-0527 HUMAN PRESCRIPTION DRUG METHADOSE methadone hydrochloride CONCENTRATE ORAL 20100310 NDA NDA017116 Mallinckrodt, Inc. METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-0532_f5ae5736-5165-44b3-b4a0-b6afb4503088 0406-0532 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen CAPSULE, GELATIN COATED ORAL 20090707 ANDA ANDA040257 Mallinckrodt, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-0540_e4695145-5da1-4274-825f-961fafb35757 0406-0540 HUMAN PRESCRIPTION DRUG METHADOSE DISPERSIBLE Methadone Hydrochloride TABLET ORAL 20100831 ANDA ANDA074184 Mallinckrodt, Inc. METHADONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-0552_78aa1bbc-4127-4f1e-88bb-fc2c4c599f45 0406-0552 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20090730 ANDA ANDA076758 Mallinckrodt, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-0582_a3461494-5959-4082-ab97-61f1c49fe5c7 0406-0582 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20110308 20150630 ANDA ANDA040550 Mallinckrodt, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-1009_eca24ee0-6725-4cc1-aa32-ff216a404677 0406-1009 HUMAN PRESCRIPTION DRUG OXYMORPHONE HYDROCHLORIDE Oxymorphone Hydrochloride TABLET ORAL 20120412 ANDA ANDA202321 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-1010_eca24ee0-6725-4cc1-aa32-ff216a404677 0406-1010 HUMAN PRESCRIPTION DRUG OXYMORPHONE HYDROCHLORIDE Oxymorphone Hydrochloride TABLET ORAL 20120412 ANDA ANDA202321 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-1142_d4c8dd93-b655-4e7f-96fd-8ed4eb500f3a 0406-1142 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20110318 ANDA ANDA040300 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-1144_d4c8dd93-b655-4e7f-96fd-8ed4eb500f3a 0406-1144 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20110318 ANDA ANDA040300 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-1146_d4c8dd93-b655-4e7f-96fd-8ed4eb500f3a 0406-1146 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20110318 ANDA ANDA040300 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-1170_92e76536-867c-4a28-97bf-35173137abe2 0406-1170 HUMAN PRESCRIPTION DRUG NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET, FILM COATED ORAL 20090729 ANDA ANDA076264 Mallinckrodt, Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] 0406-1445_d4c8dd93-b655-4e7f-96fd-8ed4eb500f3a 0406-1445 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110318 ANDA ANDA075629 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-1473_d4c8dd93-b655-4e7f-96fd-8ed4eb500f3a 0406-1473 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110318 ANDA ANDA075629 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-1510_cffd71e1-3019-4372-aaa9-46ca2b4cc68b 0406-1510 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride POWDER ORAL 20120430 NDA NDA006383 Mallinckrodt, Inc. METHADONE HYDROCHLORIDE 1 g/g Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-1923_e64389d0-af39-4b9c-8f0d-0ca04a05c1ef 0406-1923 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20130222 ANDA ANDA203136 Mallinckrodt, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 0406-1924_e64389d0-af39-4b9c-8f0d-0ca04a05c1ef 0406-1924 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20130222 ANDA ANDA203136 Mallinckrodt, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 0406-2540_e4695145-5da1-4274-825f-961fafb35757 0406-2540 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20100831 ANDA ANDA077142 Mallinckrodt, Inc. METHADONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-3005_25f90951-14f5-404e-afee-6a725ae2301b 0406-3005 HUMAN PRESCRIPTION DRUG Methylphenidate HCl Oral Solution Methylphenidate Hydrochloride SOLUTION ORAL 20130801 NDA AUTHORIZED GENERIC NDA021419 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-3010_25f90951-14f5-404e-afee-6a725ae2301b 0406-3010 HUMAN PRESCRIPTION DRUG Methylphenidate HCl Oral Solution Methylphenidate Hydrochloride SOLUTION ORAL 20130801 NDA AUTHORIZED GENERIC NDA021419 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-3243_52b188fd-3ebb-48c3-9fec-21bdaadfd0a2 0406-3243 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET ORAL 20090514 ANDA ANDA078273 Mallinckrodt, Inc. HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-3244_52b188fd-3ebb-48c3-9fec-21bdaadfd0a2 0406-3244 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET ORAL 20090514 ANDA ANDA078273 Mallinckrodt, Inc. HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-3249_52b188fd-3ebb-48c3-9fec-21bdaadfd0a2 0406-3249 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET ORAL 20090514 ANDA ANDA076855 Mallinckrodt, Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-3308_8525ae7b-f731-4ca1-9244-434259317905 0406-3308 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Extended-Release Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140612 NDA AUTHORIZED GENERIC NDA021217 Mallinckrodt, Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-3312_8525ae7b-f731-4ca1-9244-434259317905 0406-3312 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Extended-Release Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140612 NDA AUTHORIZED GENERIC NDA021217 Mallinckrodt, Inc. HYDROMORPHONE HYDROCHLORIDE 12 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-3316_8525ae7b-f731-4ca1-9244-434259317905 0406-3316 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Extended-Release Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140612 NDA AUTHORIZED GENERIC NDA021217 Mallinckrodt, Inc. HYDROMORPHONE HYDROCHLORIDE 16 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-3332_8525ae7b-f731-4ca1-9244-434259317905 0406-3332 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Extended-Release Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140612 NDA AUTHORIZED GENERIC NDA021217 Mallinckrodt, Inc. HYDROMORPHONE HYDROCHLORIDE 32 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-5755_cad1fc5a-c466-429b-988a-6983e2a78bc3 0406-5755 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20090519 ANDA ANDA040517 Mallinckrodt, Inc. METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-5771_cad1fc5a-c466-429b-988a-6983e2a78bc3 0406-5771 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20090519 ANDA ANDA040517 Mallinckrodt, Inc. METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-6974_8e571f95-d9c4-4f93-89fb-43d775b17feb 0406-6974 HUMAN PRESCRIPTION DRUG METHADOSE methadone hydrochloride TABLET ORAL 20100223 20170131 ANDA ANDA040050 Mallinckrodt, Inc. METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8003_d9fb2d6b-5913-4870-b5f0-2f226e9ffd10 0406-8003 HUMAN PRESCRIPTION DRUG Morphine Sulfate morphine sulfate SOLUTION ORAL 20111003 ANDA ANDA202348 Mallinckrodt, Inc. MORPHINE SULFATE 20 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8091_943658b3-c15a-481d-837c-804a8fa23968 0406-8091 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Extended-Release Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140627 ANDA ANDA202946 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8092_943658b3-c15a-481d-837c-804a8fa23968 0406-8092 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Extended-Release Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140627 ANDA ANDA202946 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8093_943658b3-c15a-481d-837c-804a8fa23968 0406-8093 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Extended-Release Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140627 ANDA ANDA202946 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8094_943658b3-c15a-481d-837c-804a8fa23968 0406-8094 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Extended-Release Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140627 ANDA ANDA202946 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8095_943658b3-c15a-481d-837c-804a8fa23968 0406-8095 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Extended-Release Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140627 ANDA ANDA202946 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 7.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8096_943658b3-c15a-481d-837c-804a8fa23968 0406-8096 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Extended-Release Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140627 ANDA ANDA202946 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8097_943658b3-c15a-481d-837c-804a8fa23968 0406-8097 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Extended-Release Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140627 ANDA ANDA202946 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8315_aae80a3d-dd2e-4899-beb8-dab719d5028e 0406-8315 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20101021 ANDA ANDA076412 Mallinckrodt, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8320_aae80a3d-dd2e-4899-beb8-dab719d5028e 0406-8320 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20101021 ANDA ANDA076438 Mallinckrodt, Inc. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8330_aae80a3d-dd2e-4899-beb8-dab719d5028e 0406-8330 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20101021 ANDA ANDA076412 Mallinckrodt, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8380_aae80a3d-dd2e-4899-beb8-dab719d5028e 0406-8380 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20101021 ANDA ANDA076412 Mallinckrodt, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8390_aae80a3d-dd2e-4899-beb8-dab719d5028e 0406-8390 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20101021 ANDA ANDA076438 Mallinckrodt, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8515_78aa1bbc-4127-4f1e-88bb-fc2c4c599f45 0406-8515 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20090730 ANDA ANDA076758 Mallinckrodt, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8530_78aa1bbc-4127-4f1e-88bb-fc2c4c599f45 0406-8530 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20090730 ANDA ANDA076758 Mallinckrodt, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8553_b679080e-d1a7-4595-95fd-2ce8404ac7b5 0406-8553 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN ORAL SOLUTION oxycodone and acetaminophen SOLUTION ORAL 20110310 ANDA ANDA040680 Mallinckrodt, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8725_a6c32b30-06b9-4ea3-9e12-f6b4e0130148 0406-8725 HUMAN PRESCRIPTION DRUG METHADOSE SUGAR-FREE methadone hydrochloride CONCENTRATE ORAL 20100310 NDA NDA017116 Mallinckrodt, Inc. METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-8884_67c2f300-8fad-4e88-932d-67efac2becd3 0406-8884 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20100218 ANDA ANDA040440 Mallinckrodt, Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-8885_67c2f300-8fad-4e88-932d-67efac2becd3 0406-8885 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20100218 ANDA ANDA040440 Mallinckrodt, Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-8886_67c2f300-8fad-4e88-932d-67efac2becd3 0406-8886 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20100218 ANDA ANDA040440 Mallinckrodt, Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-8891_67c2f300-8fad-4e88-932d-67efac2becd3 0406-8891 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20100218 ANDA ANDA040440 Mallinckrodt, Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-8892_67c2f300-8fad-4e88-932d-67efac2becd3 0406-8892 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20100218 ANDA ANDA040440 Mallinckrodt, Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-8893_67c2f300-8fad-4e88-932d-67efac2becd3 0406-8893 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20100218 ANDA ANDA040440 Mallinckrodt, Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-8894_67c2f300-8fad-4e88-932d-67efac2becd3 0406-8894 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20100218 ANDA ANDA040440 Mallinckrodt, Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-8958_ba012a73-423d-4422-bee7-221cbaf460d2 0406-8958 HUMAN PRESCRIPTION DRUG DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET ORAL 20100205 ANDA ANDA040436 Mallinckrodt, Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-8959_ba012a73-423d-4422-bee7-221cbaf460d2 0406-8959 HUMAN PRESCRIPTION DRUG DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET ORAL 20100205 ANDA ANDA040436 Mallinckrodt, Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-8960_614b8164-2c38-4e89-89ca-0d87434e7f82 0406-8960 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Extended-Release dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111007 ANDA ANDA076353 Mallinckrodt, Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-8961_614b8164-2c38-4e89-89ca-0d87434e7f82 0406-8961 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Extended-Release dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111007 ANDA ANDA076353 Mallinckrodt, Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-8962_614b8164-2c38-4e89-89ca-0d87434e7f82 0406-8962 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Extended-Release dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111007 ANDA ANDA076353 Mallinckrodt, Inc. DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0406-9000_d1c04337-e191-4da8-9bcc-609de105648c 0406-9000 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Mallinckrodt, Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-9025_d1c04337-e191-4da8-9bcc-609de105648c 0406-9025 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Mallinckrodt, Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-9050_d1c04337-e191-4da8-9bcc-609de105648c 0406-9050 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Mallinckrodt, Inc. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-9075_d1c04337-e191-4da8-9bcc-609de105648c 0406-9075 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Mallinckrodt, Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-9202_20a89576-eb6d-4a50-a16f-9e72163e4ded 0406-9202 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE FENTANYL CITRATE LOZENGE TRANSMUCOSAL 20100115 ANDA ANDA078907 Mallinckrodt Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-9204_20a89576-eb6d-4a50-a16f-9e72163e4ded 0406-9204 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE FENTANYL CITRATE LOZENGE TRANSMUCOSAL 20100115 ANDA ANDA078907 Mallinckrodt Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-9206_20a89576-eb6d-4a50-a16f-9e72163e4ded 0406-9206 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE FENTANYL CITRATE LOZENGE TRANSMUCOSAL 20100115 ANDA ANDA078907 Mallinckrodt Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-9208_20a89576-eb6d-4a50-a16f-9e72163e4ded 0406-9208 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE FENTANYL CITRATE LOZENGE TRANSMUCOSAL 20100115 ANDA ANDA078907 Mallinckrodt Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-9212_20a89576-eb6d-4a50-a16f-9e72163e4ded 0406-9212 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE FENTANYL CITRATE LOZENGE TRANSMUCOSAL 20100115 ANDA ANDA078907 Mallinckrodt Inc. FENTANYL CITRATE 1200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-9216_20a89576-eb6d-4a50-a16f-9e72163e4ded 0406-9216 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE FENTANYL CITRATE LOZENGE TRANSMUCOSAL 20100115 ANDA ANDA078907 Mallinckrodt Inc. FENTANYL CITRATE 1600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0406-9906_58134033-d8c2-4c15-b842-837c5851b2fc 0406-9906 HUMAN PRESCRIPTION DRUG ANAFRANIL clomipramine hydrochloride CAPSULE ORAL 20110318 NDA NDA019906 Mallinckrodt, Inc. CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0406-9907_58134033-d8c2-4c15-b842-837c5851b2fc 0406-9907 HUMAN PRESCRIPTION DRUG ANAFRANIL clomipramine hydrochloride CAPSULE ORAL 20110318 NDA NDA019906 Mallinckrodt, Inc. CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0406-9908_58134033-d8c2-4c15-b842-837c5851b2fc 0406-9908 HUMAN PRESCRIPTION DRUG ANAFRANIL clomipramine hydrochloride CAPSULE ORAL 20110318 NDA NDA019906 Mallinckrodt, Inc. CLOMIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 0406-9910_09efb8b1-dcf6-4b85-920a-84037bde93a5 0406-9910 HUMAN PRESCRIPTION DRUG PAMELOR nortriptyline hydrochloride CAPSULE ORAL 20100803 NDA NDA018013 Mallinckrodt, Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0406-9911_09efb8b1-dcf6-4b85-920a-84037bde93a5 0406-9911 HUMAN PRESCRIPTION DRUG PAMELOR nortriptyline hydrochloride CAPSULE ORAL 20100803 NDA NDA018013 Mallinckrodt, Inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0406-9912_09efb8b1-dcf6-4b85-920a-84037bde93a5 0406-9912 HUMAN PRESCRIPTION DRUG PAMELOR nortriptyline hydrochloride CAPSULE ORAL 20100803 NDA NDA018013 Mallinckrodt, Inc. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0406-9913_09efb8b1-dcf6-4b85-920a-84037bde93a5 0406-9913 HUMAN PRESCRIPTION DRUG PAMELOR nortriptyline hydrochloride CAPSULE ORAL 20100803 NDA NDA018013 Mallinckrodt, Inc. NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 0406-9914_347b4906-e7b4-4096-a30b-fcdaf2a1bc28 0406-9914 HUMAN PRESCRIPTION DRUG RESTORIL temazepam CAPSULE ORAL 20110707 NDA NDA018163 Mallinckrodt, Inc. TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0406-9915_347b4906-e7b4-4096-a30b-fcdaf2a1bc28 0406-9915 HUMAN PRESCRIPTION DRUG RESTORIL temazepam CAPSULE ORAL 20110707 NDA NDA018163 Mallinckrodt, Inc. TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0406-9916_347b4906-e7b4-4096-a30b-fcdaf2a1bc28 0406-9916 HUMAN PRESCRIPTION DRUG RESTORIL temazepam CAPSULE ORAL 20110707 NDA NDA018163 Mallinckrodt, Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0406-9917_347b4906-e7b4-4096-a30b-fcdaf2a1bc28 0406-9917 HUMAN PRESCRIPTION DRUG RESTORIL temazepam CAPSULE ORAL 20110707 NDA NDA018163 Mallinckrodt, Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0406-9920_78dbb631-7869-49bc-bc20-8e412e0bc504 0406-9920 HUMAN PRESCRIPTION DRUG TOFRANIL imipramine hydrochloride TABLET, SUGAR COATED ORAL 20110124 ANDA ANDA087844 Mallinckrodt, Inc. IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0406-9921_78dbb631-7869-49bc-bc20-8e412e0bc504 0406-9921 HUMAN PRESCRIPTION DRUG TOFRANIL imipramine hydrochloride TABLET, SUGAR COATED ORAL 20110124 ANDA ANDA087845 Mallinckrodt, Inc. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0406-9922_78dbb631-7869-49bc-bc20-8e412e0bc504 0406-9922 HUMAN PRESCRIPTION DRUG TOFRANIL imipramine hydrochloride TABLET, SUGAR COATED ORAL 20110124 ANDA ANDA087846 Mallinckrodt, Inc. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0406-9923_d3f6eb08-1111-4f30-b198-89dbc8ccf10b 0406-9923 HUMAN PRESCRIPTION DRUG TOFRANIL-PM imipramine pamoate CAPSULE ORAL 20091104 NDA NDA017090 Mallinckrodt, Inc. IMIPRAMINE PAMOATE 75 mg/1 Tricyclic Antidepressant [EPC] 0406-9924_d3f6eb08-1111-4f30-b198-89dbc8ccf10b 0406-9924 HUMAN PRESCRIPTION DRUG TOFRANIL-PM imipramine pamoate CAPSULE ORAL 20091104 NDA NDA017090 Mallinckrodt, Inc. IMIPRAMINE PAMOATE 100 mg/1 Tricyclic Antidepressant [EPC] 0406-9925_d3f6eb08-1111-4f30-b198-89dbc8ccf10b 0406-9925 HUMAN PRESCRIPTION DRUG TOFRANIL-PM imipramine pamoate CAPSULE ORAL 20091104 NDA NDA017090 Mallinckrodt, Inc. IMIPRAMINE PAMOATE 125 mg/1 Tricyclic Antidepressant [EPC] 0406-9926_d3f6eb08-1111-4f30-b198-89dbc8ccf10b 0406-9926 HUMAN PRESCRIPTION DRUG TOFRANIL-PM imipramine pamoate CAPSULE ORAL 20091104 NDA NDA017090 Mallinckrodt, Inc. IMIPRAMINE PAMOATE 150 mg/1 Tricyclic Antidepressant [EPC] 0406-9931_068cf9b1-20e5-4551-b095-32d929006277 0406-9931 HUMAN PRESCRIPTION DRUG IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE CAPSULE ORAL 20091015 NDA NDA017090 Mallinckrodt, Inc. IMIPRAMINE PAMOATE 75 mg/1 Tricyclic Antidepressant [EPC] 0406-9932_068cf9b1-20e5-4551-b095-32d929006277 0406-9932 HUMAN PRESCRIPTION DRUG IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE CAPSULE ORAL 20091015 NDA NDA017090 Mallinckrodt, Inc. IMIPRAMINE PAMOATE 100 mg/1 Tricyclic Antidepressant [EPC] 0406-9933_068cf9b1-20e5-4551-b095-32d929006277 0406-9933 HUMAN PRESCRIPTION DRUG IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE CAPSULE ORAL 20091015 NDA NDA017090 Mallinckrodt, Inc. IMIPRAMINE PAMOATE 125 mg/1 Tricyclic Antidepressant [EPC] 0406-9934_068cf9b1-20e5-4551-b095-32d929006277 0406-9934 HUMAN PRESCRIPTION DRUG IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE CAPSULE ORAL 20091015 NDA NDA017090 Mallinckrodt, Inc. IMIPRAMINE PAMOATE 150 mg/1 Tricyclic Antidepressant [EPC] 0406-9959_56692bb6-8f8c-4bb4-931c-58000a31db7a 0406-9959 HUMAN PRESCRIPTION DRUG TEMAZEPAM temazepam CAPSULE ORAL 20100223 NDA NDA018163 Mallinckrodt, Inc. TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0406-9960_56692bb6-8f8c-4bb4-931c-58000a31db7a 0406-9960 HUMAN PRESCRIPTION DRUG TEMAZEPAM temazepam CAPSULE ORAL 20100223 NDA NDA018163 Mallinckrodt, Inc. TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0407-0690_15b07413-46d6-4b95-b729-bb6a25f86015 0407-0690 HUMAN PRESCRIPTION DRUG OMNISCAN gadodiamide INJECTION INTRAVENOUS 20020419 NDA NDA020123 GE Healthcare Inc. GADODIAMIDE 287 mg/mL Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0407-0690_775e7bb2-943c-4d02-ab68-06361329be31 0407-0690 HUMAN PRESCRIPTION DRUG OMNISCAN gadodiamide INJECTION INTRAVENOUS 20100601 NDA NDA020123 GE Healthcare Inc. GADODIAMIDE 287 mg/mL Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0407-0690_b5f0d4c7-8aaa-4288-9680-090802ed809a 0407-0690 HUMAN PRESCRIPTION DRUG OMNISCAN gadodiamide INJECTION INTRAVENOUS 20071002 NDA NDA022066 GE Healthcare Inc. GADODIAMIDE 287 mg/mL Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0407-0691_15b07413-46d6-4b95-b729-bb6a25f86015 0407-0691 HUMAN PRESCRIPTION DRUG OMNISCAN gadodiamide INJECTION INTRAVENOUS 20060921 NDA NDA020123 GE Healthcare Inc. GADODIAMIDE 287 mg/mL Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0407-0691_775e7bb2-943c-4d02-ab68-06361329be31 0407-0691 HUMAN PRESCRIPTION DRUG OMNISCAN gadodiamide INJECTION INTRAVENOUS 20050729 NDA NDA020123 GE Healthcare Inc. GADODIAMIDE 287 mg/mL Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0407-1401_5e18ba7f-51bb-4292-a54c-151b25de66aa 0407-1401 HUMAN PRESCRIPTION DRUG OMNIPAQUE Iohexol INJECTION INTRAVENOUS 20040525 NDA NDA018956 GE Healthcare Inc. IOHEXOL 302 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0407-1411_5e18ba7f-51bb-4292-a54c-151b25de66aa 0407-1411 HUMAN PRESCRIPTION DRUG OMNIPAQUE Iohexol INJECTION INTRAVENOUS 20040715 NDA NDA018956 GE Healthcare Inc. IOHEXOL 388.3 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0407-1412_5e18ba7f-51bb-4292-a54c-151b25de66aa 0407-1412 HUMAN PRESCRIPTION DRUG OMNIPAQUE Iohexol INJECTION INTRAVENOUS 19851226 NDA NDA018956 GE Healthcare Inc. IOHEXOL 518 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0407-1412_8189551d-c91e-4031-88d9-3dd0f2ab8c97 0407-1412 HUMAN PRESCRIPTION DRUG OMNIPAQUE Iohexol INJECTION INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL 20050811 NDA NDA018956 GE Healthcare Inc. IOHEXOL 518 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0407-1413_4d0518db-f822-4bb2-8a28-c85191bd70ec 0407-1413 HUMAN PRESCRIPTION DRUG Omnipaque Iohexol INJECTION, SOLUTION INTRAVENOUS 20040903 NDA NDA020608 GE Healthcare Inc. IOHEXOL 647.1 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0407-1413_5e18ba7f-51bb-4292-a54c-151b25de66aa 0407-1413 HUMAN PRESCRIPTION DRUG OMNIPAQUE Iohexol INJECTION INTRAVENOUS 19851226 NDA NDA018956 GE Healthcare Inc. IOHEXOL 647 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0407-1413_8189551d-c91e-4031-88d9-3dd0f2ab8c97 0407-1413 HUMAN PRESCRIPTION DRUG OMNIPAQUE Iohexol INJECTION INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL 20060921 NDA NDA018956 GE Healthcare Inc. IOHEXOL 647 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0407-1413_8a4511e4-21bc-4d1a-8876-14b52b282a3a 0407-1413 HUMAN PRESCRIPTION DRUG Omnipaque Iohexol INJECTION INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL 20050803 NDA NDA020608 GE Healthcare Inc. IOHEXOL 300 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0407-1414_4d0518db-f822-4bb2-8a28-c85191bd70ec 0407-1414 HUMAN PRESCRIPTION DRUG Omnipaque Iohexol INJECTION, SOLUTION INTRAVENOUS 20040903 NDA NDA020608 GE Healthcare Inc. IOHEXOL 755 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0407-1414_5e18ba7f-51bb-4292-a54c-151b25de66aa 0407-1414 HUMAN PRESCRIPTION DRUG OMNIPAQUE Iohexol INJECTION INTRAVENOUS 19851226 NDA NDA018956 GE Healthcare Inc. IOHEXOL 755 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0407-1414_8189551d-c91e-4031-88d9-3dd0f2ab8c97 0407-1414 HUMAN PRESCRIPTION DRUG OMNIPAQUE Iohexol INJECTION INTRAVASCULAR; INTRAVENOUS; ORAL 20060721 NDA NDA018956 GE Healthcare Inc. IOHEXOL 755 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0407-1414_8a4511e4-21bc-4d1a-8876-14b52b282a3a 0407-1414 HUMAN PRESCRIPTION DRUG Omnipaque Iohexol INJECTION INTRAVASCULAR; INTRAVENOUS; ORAL 20050803 NDA NDA020608 GE Healthcare Inc. IOHEXOL 350 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0407-2222_7df2a670-375f-4203-a795-5681733ef1d8 0407-2222 HUMAN PRESCRIPTION DRUG Visipaque Iodixanol INJECTION, SOLUTION INTRAVASCULAR 20021213 NDA NDA020351 GE Healthcare Inc. IODIXANOL 270 mg/mL 0407-2222_884908b2-f091-462b-8736-4fdb94a8d4b0 0407-2222 HUMAN PRESCRIPTION DRUG Visipaque Iodixanol INJECTION, SOLUTION INTRAVASCULAR 20090301 NDA NDA020808 GE Healthcare Inc. IODIXANOL 270 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0407-2223_7df2a670-375f-4203-a795-5681733ef1d8 0407-2223 HUMAN PRESCRIPTION DRUG Visipaque Iodixanol INJECTION, SOLUTION INTRAVASCULAR 20030909 NDA NDA020351 GE Healthcare Inc. IODIXANOL 320 mg/mL 0407-2223_884908b2-f091-462b-8736-4fdb94a8d4b0 0407-2223 HUMAN PRESCRIPTION DRUG Visipaque Iodixanol INJECTION, SOLUTION INTRAVASCULAR 20060501 NDA NDA020808 GE Healthcare Inc. IODIXANOL 320 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 0407-2223_8db4e8f0-d5bf-40e4-bd42-b477d36ddda0 0407-2223 HUMAN PRESCRIPTION DRUG Visipaque Iodixanol INJECTION, SOLUTION INTRAVASCULAR 20100601 NDA NDA020351 GE Healthcare Inc. IODIXANOL 320 mg/mL 0407-2707_3362a53e-3f03-40bb-91fa-98b495c37977 0407-2707 HUMAN PRESCRIPTION DRUG Optison Perflutren Protein-Type A Microspheres Human Albumin Microspheres and Perflutren INJECTION, SOLUTION INTRAVENOUS 20020102 NDA NDA020899 GE Healthcare Inc. HUMAN ALBUMIN MICROSPHERES; PERFLUTREN 10; .22 mg/mL; mg/mL Contrast Agent for Ultrasound Imaging [EPC],Ultrasound Contrast Activity [MoA],Contrast Agent for Ultrasound Imaging [EPC],Ultrasound Contrast Activity [MoA] 0407-4086_9534912b-d72f-4ce4-9c67-07a2214ebb59 0407-4086 HUMAN PRESCRIPTION DRUG Cysview hexaminolevulinate hydrochloride KIT 20100901 NDA NDA022555 GE Healthcare Inc. 0409-0106_5aa20a34-65e5-46f0-a2ca-fc3986e68112 0409-0106 HUMAN PRESCRIPTION DRUG Daptomycin DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140912 ANDA ANDA202857 Hospira, Inc. DAPTOMYCIN 50 mg/mL Lipopeptide Antibacterial [EPC],Lipopeptides [Chemical/Ingredient] 0409-0144_7648252e-d00c-4528-bea5-532d42a9a63e 0409-0144 HUMAN PRESCRIPTION DRUG Azithromycin AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090626 ANDA ANDA065511 Hospira, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0409-0144_c0af06bc-9df6-4a9c-9272-eab0ccea1c19 0409-0144 HUMAN PRESCRIPTION DRUG Azithromycin AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090626 ANDA ANDA065500 Hospira, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0409-0181_4d39651e-9634-4600-8e85-a26d59e9fe6a 0409-0181 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110804 NDA NDA200795 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0409-0181_8df4c455-5b17-40a8-ae1d-9d5f86d11727 0409-0181 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110804 NDA NDA200795 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0409-0182_4d39651e-9634-4600-8e85-a26d59e9fe6a 0409-0182 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110804 NDA NDA200795 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0409-0182_8df4c455-5b17-40a8-ae1d-9d5f86d11727 0409-0182 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110804 NDA NDA200795 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0409-0183_4d39651e-9634-4600-8e85-a26d59e9fe6a 0409-0183 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110804 NDA NDA200795 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0409-0183_8df4c455-5b17-40a8-ae1d-9d5f86d11727 0409-0183 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110804 NDA NDA200795 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0409-0185_f63acd13-ba91-4883-b65c-e2dc46a44ffa 0409-0185 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA078339 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0409-0186_f63acd13-ba91-4883-b65c-e2dc46a44ffa 0409-0186 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA078339 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0409-0187_c9981fc3-ae63-483f-bbbf-29de04246233 0409-0187 HUMAN PRESCRIPTION DRUG GEMCITABINE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20101115 ANDA ANDA079183 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0409-0201_5ceb0707-bf63-459c-8b87-7844197849cb 0409-0201 HUMAN PRESCRIPTION DRUG Docetaxel DOCETAXEL ANHYDROUS INJECTION, SOLUTION INTRAVENOUS 20110308 NDA NDA022234 Hospira, Inc. DOCETAXEL ANHYDROUS 10 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 0409-0212_813e8ca2-de54-4a7c-a2d2-8bd44396c341 0409-0212 HUMAN PRESCRIPTION DRUG MILRINONE LACTATE MILRINONE LACTATE INJECTION, SOLUTION INTRAVENOUS 20140903 ANDA ANDA203280 Hospira, Inc. MILRINONE LACTATE 1 mg/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0409-0217_7416ff7b-5b5e-4005-b10b-6fb2bfee2ddf 0409-0217 HUMAN PRESCRIPTION DRUG Maxipime CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121227 NDA NDA050679 Hospira, Inc. CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-0218_7416ff7b-5b5e-4005-b10b-6fb2bfee2ddf 0409-0218 HUMAN PRESCRIPTION DRUG Maxipime CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121227 NDA NDA050679 Hospira, Inc. CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-0219_7416ff7b-5b5e-4005-b10b-6fb2bfee2ddf 0409-0219 HUMAN PRESCRIPTION DRUG Maxipime CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121227 NDA NDA050679 Hospira, Inc. CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-0220_7416ff7b-5b5e-4005-b10b-6fb2bfee2ddf 0409-0220 HUMAN PRESCRIPTION DRUG Maxipime CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121227 NDA NDA050679 Hospira, Inc. CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-0221_7416ff7b-5b5e-4005-b10b-6fb2bfee2ddf 0409-0221 HUMAN PRESCRIPTION DRUG Maxipime CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121227 NDA NDA050679 Hospira, Inc. CEFEPIME HYDROCHLORIDE 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-0302_235d0a2a-594a-45e0-aa4c-74a2df615e1a 0409-0302 HUMAN PRESCRIPTION DRUG Topotecan TOPOTECAN HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130924 NDA NDA200582 Hospira, Inc. TOPOTECAN HYDROCHLORIDE 1 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0409-0302_f132be0d-8fc4-4f55-b213-06e7872c8be8 0409-0302 HUMAN PRESCRIPTION DRUG Topotecan TOPOTECAN HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20110202 NDA NDA200582 Hospira, Inc. TOPOTECAN HYDROCHLORIDE 1 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0409-0468_a78532c7-f1b4-446b-9b2a-103e51590629 0409-0468 HUMAN PRESCRIPTION DRUG Novamine LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20111122 NDA NDA017957 Hospira, Inc. ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960 g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0409-0801_00a48fa7-7e3f-49e0-b06e-db506369e2d3 0409-0801 HUMAN PRESCRIPTION DRUG Nipent PENTOSTATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19911011 NDA NDA020122 Hospira, Inc. PENTOSTATIN 2 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0409-0802_90d7095e-1a39-4c18-a211-8f6f78d8d280 0409-0802 HUMAN PRESCRIPTION DRUG Cefuroxime CEFUROXIME INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20090427 ANDA ANDA065503 Hospira, Inc. CEFUROXIME SODIUM 90 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-0805_ac14c666-8778-44ef-be78-27441eea4e1a 0409-0805 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090324 ANDA ANDA065226 Hospira, Inc. CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-0806_6e650351-f728-4a40-bdc7-9b6c86101d5a 0409-0806 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20090324 ANDA ANDA065247 Hospira, Inc. CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-0807_fc73f16a-66a3-4847-b5bd-11a916889db0 0409-0807 HUMAN PRESCRIPTION DRUG Ceftriaxone sodium CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120820 ANDA ANDA202563 Hospira, Inc. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-0808_fc73f16a-66a3-4847-b5bd-11a916889db0 0409-0808 HUMAN PRESCRIPTION DRUG Ceftriaxone sodium CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120820 ANDA ANDA202563 Hospira, Inc. CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-0809_bc09c6d0-d856-4136-a56c-868739744ad4 0409-0809 HUMAN PRESCRIPTION DRUG Cefepime CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120730 ANDA ANDA202268 Hospira, Inc. CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-0810_bc09c6d0-d856-4136-a56c-868739744ad4 0409-0810 HUMAN PRESCRIPTION DRUG Cefepime CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120730 ANDA ANDA202268 Hospira, Inc. CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-0996_01cca648-abb8-4d0c-80f9-d10befb9f8bd 0409-0996 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine Lidocaine Hydrochloride,Epinephrine Bitartrate INJECTION, SOLUTION DENTAL; INFILTRATION 20100210 ANDA ANDA078772 Hospira, Inc. EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-1007_f85817fb-ede9-4bbd-80ab-a1b67f09fa28 0409-1007 HUMAN PRESCRIPTION DRUG Paricalcitol PARICALCITOL INJECTION, SOLUTION INTRAVENOUS 20141101 NDA NDA201657 Hospira, Inc. PARICALCITOL 2 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0409-1008_f85817fb-ede9-4bbd-80ab-a1b67f09fa28 0409-1008 HUMAN PRESCRIPTION DRUG Paricalcitol PARICALCITOL INJECTION, SOLUTION INTRAVENOUS 20141101 NDA NDA201657 Hospira, Inc. PARICALCITOL 5 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0409-1029_c3fc11e8-99c3-46d1-ba94-2417430c3995 0409-1029 HUMAN PRESCRIPTION DRUG Voluven HYDROXYETHYL STARCH 130/0.4 INJECTION, SOLUTION INTRAVENOUS 20100625 NDA BN070012 Hospira Inc. HYDROXYETHYL STARCH 130/0.4 6 g/100mL Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [Chemical/Ingredient] 0409-1036_464cee15-0d9a-446d-9453-dd9deca4e13f 0409-1036 HUMAN PRESCRIPTION DRUG Carbocaine Mepivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION 20100308 NDA NDA012250 Hospira, Inc. MEPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1038_464cee15-0d9a-446d-9453-dd9deca4e13f 0409-1038 HUMAN PRESCRIPTION DRUG Carbocaine Mepivacaine Hydrochloride INJECTION, SOLUTION INFILTRATION 20100308 NDA NDA012250 Hospira, Inc. MEPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1041_464cee15-0d9a-446d-9453-dd9deca4e13f 0409-1041 HUMAN PRESCRIPTION DRUG Carbocaine Mepivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION 20100308 NDA NDA012250 Hospira, Inc. MEPIVACAINE HYDROCHLORIDE 15 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1067_464cee15-0d9a-446d-9453-dd9deca4e13f 0409-1067 HUMAN PRESCRIPTION DRUG Carbocaine Mepivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION 20100308 NDA NDA012250 Hospira, Inc. MEPIVACAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1105_d8cebadb-7059-47d6-9901-5c133c48dc90 0409-1105 HUMAN PRESCRIPTION DRUG Atracurium Besylate ATRACURIUM BESYLATE INJECTION, SOLUTION INTRAVENOUS 20121018 ANDA ANDA090761 Hospira, Inc. ATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0409-1109_d8cebadb-7059-47d6-9901-5c133c48dc90 0409-1109 HUMAN PRESCRIPTION DRUG Atracurium Besylate ATRACURIUM BESYLATE INJECTION, SOLUTION INTRAVENOUS 20121018 ANDA ANDA090782 Hospira, Inc. ATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0409-1120_bae882a4-8c26-4a66-bb82-c36f406f8362 0409-1120 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070119 ANDA ANDA077840 Hospira, Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0409-1130_9100d08d-dbe9-4b95-bd64-87a6102e14fd 0409-1130 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE SOLUTION, CONCENTRATE INTRAVENOUS 20050526 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM CHLORIDE 234 mg/mL 0409-1134_edf46633-836f-49d7-9163-bd85537832a9 0409-1134 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19960314 UNAPPROVED DRUG OTHER Hospira, Inc. MORPHINE SULFATE 50 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1135_edf46633-836f-49d7-9163-bd85537832a9 0409-1135 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19960314 UNAPPROVED DRUG OTHER Hospira, Inc. MORPHINE SULFATE 25 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1141_e5ea67f2-c000-448c-a1b7-b9546491d311 0409-1141 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050430 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM CHLORIDE 234 mg/mL 0409-1144_e6213a51-c663-4cd4-bdf7-560e4f047d58 0409-1144 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19870506 ANDA ANDA070737 Hospira, Inc. VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0409-1158_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-1158 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 19870303 ANDA ANDA070586 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1159_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-1159 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 19870217 ANDA ANDA070583 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1160_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-1160 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 19870217 ANDA ANDA070590 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1161_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-1161 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INTRACAUDAL 19870303 ANDA ANDA070609 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1162_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-1162 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INTRACAUDAL 19870217 ANDA ANDA070584 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1163_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-1163 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 19870303 ANDA ANDA070597 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1165_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-1165 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; RETROBULBAR 19870303 ANDA ANDA070585 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1171_0f5edb53-271c-4b00-8bef-4c694edbf71c 0409-1171 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20120410 ANDA ANDA074941 Hospira, Inc. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0409-1176_6b4bf17b-3b67-4318-924d-60e3bc24cd2d 0409-1176 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20101130 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 25 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1178_6b4bf17b-3b67-4318-924d-60e3bc24cd2d 0409-1178 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20101130 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 50 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1179_6b4bf17b-3b67-4318-924d-60e3bc24cd2d 0409-1179 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20101130 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 75 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1180_6b4bf17b-3b67-4318-924d-60e3bc24cd2d 0409-1180 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20101130 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 100 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1181_6b4bf17b-3b67-4318-924d-60e3bc24cd2d 0409-1181 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20101130 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 50 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1187_dbe5ebe3-9ef5-4cf7-b00d-c178c9a518e2 0409-1187 HUMAN PRESCRIPTION DRUG Droperidol DROPERIDOL INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19880229 ANDA ANDA071981 Hospira, Inc. DROPERIDOL 2.5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0409-1201_6b4bf17b-3b67-4318-924d-60e3bc24cd2d 0409-1201 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20101130 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 100 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1203_6b4bf17b-3b67-4318-924d-60e3bc24cd2d 0409-1203 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20101130 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 25 mg/.5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1207_9793d819-b777-4312-a731-9cb0665fc944 0409-1207 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate GENTAMICIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19830808 ANDA ANDA062420 Hospira, Inc. GENTAMICIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0409-1207_f05abe69-df12-4141-8688-de977d3dc913 0409-1207 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate GENTAMICIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140701 ANDA ANDA062420 Hospira, Inc. GENTAMICIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0409-1209_34026e93-65f9-4473-a1f2-bd75339c805c 0409-1209 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE and EPINEPHRINE INJECTION, SOLUTION EPIDURAL 19850913 ANDA ANDA088571 Hospira, Inc. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 5; 15 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-1212_5233dfa1-7e54-4151-8463-2b1dd73910dd 0409-1212 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19870107 ANDA ANDA070254 Hospira, Inc. NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 0409-1215_5233dfa1-7e54-4151-8463-2b1dd73910dd 0409-1215 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19870107 ANDA ANDA070256 Hospira, Inc. NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 0409-1215_559966e2-4576-4360-b3e8-aa5ec20f4eec 0409-1215 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20140501 ANDA ANDA070256 Hospira, Inc. NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 0409-1219_5233dfa1-7e54-4151-8463-2b1dd73910dd 0409-1219 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19870107 ANDA ANDA070257 Hospira, Inc. NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 0409-1219_559966e2-4576-4360-b3e8-aa5ec20f4eec 0409-1219 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20140409 ANDA ANDA070257 Hospira, Inc. NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 0409-1253_6b4bf17b-3b67-4318-924d-60e3bc24cd2d 0409-1253 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20101130 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 50 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1254_6b4bf17b-3b67-4318-924d-60e3bc24cd2d 0409-1254 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20101130 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 75 mg/1.5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1255_6b4bf17b-3b67-4318-924d-60e3bc24cd2d 0409-1255 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20101130 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 100 mg/2mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1256_6b4bf17b-3b67-4318-924d-60e3bc24cd2d 0409-1256 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20101130 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 100 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1273_9375075c-22da-41c1-8bdc-07c51593c84c 0409-1273 HUMAN PRESCRIPTION DRUG Diazepam DIAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19881220 ANDA ANDA072079 Hospira, Inc. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-1273_d370ca6c-2c6c-415c-8bea-1c14a0a647f1 0409-1273 HUMAN PRESCRIPTION DRUG Diazepam Diazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19881220 ANDA ANDA072079 Hospira, Inc. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-1276_385842d8-92a7-40fe-aeab-8575af85ffbd 0409-1276 HUMAN PRESCRIPTION DRUG Fentanyl Citrate FENTANYL CITRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19910924 ANDA ANDA072786 Hospira, Inc. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1283_ba33d896-0954-41e7-bc4f-462d84b1c726 0409-1283 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20111201 NDA NDA200403 Hospira, Inc. HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1304_ba33d896-0954-41e7-bc4f-462d84b1c726 0409-1304 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20111201 NDA NDA200403 Hospira, Inc. HYDROMORPHONE HYDROCHLORIDE 4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1312_ba33d896-0954-41e7-bc4f-462d84b1c726 0409-1312 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20111201 NDA NDA200403 Hospira, Inc. HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1316_039e2a91-3ff9-4302-aa48-a117220adfda 0409-1316 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20050228 ANDA ANDA089522 Hospira, Inc. HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0409-1316_71ff3604-21d7-43e5-8276-8c933594a7f8 0409-1316 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19870504 ANDA ANDA089522 Hospira, Inc. HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0409-1317_0dfecd10-384e-4237-8064-3d6a82db90e8 0409-1317 HUMAN PRESCRIPTION DRUG Phenytoin Sodium PHENYTOIN SODIUM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19870317 ANDA ANDA089521 Hospira, Inc. PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0409-1323_5912fa62-8d33-4c9f-bc4e-dc83f55a406f 0409-1323 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19980928 ANDA ANDA040302 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-1402_039e2a91-3ff9-4302-aa48-a117220adfda 0409-1402 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20050131 ANDA ANDA088100 Hospira, Inc. HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0409-1410_4ea8ff7f-609c-4698-9185-a5ece86ccb9f 0409-1410 HUMAN PRESCRIPTION DRUG Isuprel ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20120618 NDA NDA010515 Hospira, Inc. ISOPROTERENOL HYDROCHLORIDE .2 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 0409-1412_0e487e17-d1b6-4595-9f66-b234886e76d8 0409-1412 HUMAN PRESCRIPTION DRUG Bumetanide BUMETANIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19941031 ANDA ANDA074332 Hospira, Inc. BUMETANIDE .25 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0409-1412_c1ef4e6b-8ae0-43ac-9ddd-31764c317920 0409-1412 HUMAN PRESCRIPTION DRUG Bumetanide BUMETANIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080723 ANDA ANDA074332 Hospira, Inc. BUMETANIDE .25 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0409-1442_ccb8f8a1-d89f-46d9-a5d1-0e8bafca27fb 0409-1442 HUMAN PRESCRIPTION DRUG Isuprel ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20130321 NDA NDA010515 Hospira, Inc. ISOPROTERENOL HYDROCHLORIDE .2 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 0409-1443_332eb523-3a2e-42af-8721-78d16c660cd9 0409-1443 HUMAN PRESCRIPTION DRUG Levophed Norepinephrine bitartrate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19500713 NDA NDA007513 Hospira, Inc. NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-1443_5f4cabb5-4911-4464-a1fa-38bcd87ca152 0409-1443 HUMAN PRESCRIPTION DRUG Levophed Norepinephrine bitartrate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19500713 NDA NDA007513 Hospira, Inc. NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-1463_747534be-3bd7-45fa-b758-442d6661ef7a 0409-1463 HUMAN PRESCRIPTION DRUG Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19890203 ANDA ANDA070914 Hospira, Inc. NALBUPHINE HYDROCHLORIDE 10 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] 0409-1464_747534be-3bd7-45fa-b758-442d6661ef7a 0409-1464 HUMAN PRESCRIPTION DRUG Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19890203 ANDA ANDA070915 Hospira, Inc. NALBUPHINE HYDROCHLORIDE 10 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] 0409-1465_747534be-3bd7-45fa-b758-442d6661ef7a 0409-1465 HUMAN PRESCRIPTION DRUG Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19890203 ANDA ANDA070916 Hospira, Inc. NALBUPHINE HYDROCHLORIDE 20 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] 0409-1467_747534be-3bd7-45fa-b758-442d6661ef7a 0409-1467 HUMAN PRESCRIPTION DRUG Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19890203 ANDA ANDA070918 Hospira, Inc. NALBUPHINE HYDROCHLORIDE 20 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] 0409-1482_e9be3cd3-bba7-433b-b194-19fdd4d97d1d 0409-1482 HUMAN PRESCRIPTION DRUG Nitroglycerin in Dextrose NITROGLYCERIN INJECTION, SOLUTION INTRAVENOUS 19900831 ANDA ANDA071847 Hospira, Inc. NITROGLYCERIN 200 ug/mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0409-1483_e9be3cd3-bba7-433b-b194-19fdd4d97d1d 0409-1483 HUMAN PRESCRIPTION DRUG Nitroglycerin in Dextrose NITROGLYCERIN INJECTION, SOLUTION INTRAVENOUS 19900831 ANDA ANDA071846 Hospira, Inc. NITROGLYCERIN 100 ug/mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0409-1484_e9be3cd3-bba7-433b-b194-19fdd4d97d1d 0409-1484 HUMAN PRESCRIPTION DRUG Nitroglycerin in Dextrose NITROGLYCERIN INJECTION, SOLUTION INTRAVENOUS 19900831 ANDA ANDA071848 Hospira, Inc. NITROGLYCERIN 400 ug/mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0409-1513_47f8cdde-d209-40c3-9b18-91b09399424f 0409-1513 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19720316 ANDA ANDA080205 Hospira, Inc. POTASSIUM CHLORIDE 149 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-1539_8aed9b3e-3849-4454-a7a9-1760b8f96894 0409-1539 HUMAN PRESCRIPTION DRUG Lorazepam LORAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110526 ANDA ANDA074243 Hospira, Inc. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-1555_fedfb5c2-d505-488e-832a-e6c4f752dfe5 0409-1555 HUMAN PRESCRIPTION DRUG Hextend HETASTARCH INJECTION, SOLUTION INTRAVENOUS 19990331 NDA BN200952 Hospira, Inc. HETASTARCH 6 g/100mL Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [Chemical/Ingredient] 0409-1559_94b18666-79b1-4baf-a9ba-be34b8066075 0409-1559 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20090908 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1560_94b18666-79b1-4baf-a9ba-be34b8066075 0409-1560 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20100504 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1582_94b18666-79b1-4baf-a9ba-be34b8066075 0409-1582 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; RETROBULBAR 20090909 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1587_94b18666-79b1-4baf-a9ba-be34b8066075 0409-1587 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 20090908 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1590_5cf21128-2bd9-4e95-9bd1-27631b5451a1 0409-1590 HUMAN PRESCRIPTION DRUG Sterile Water WATER LIQUID INTRAVENOUS 19710623 UNAPPROVED DRUG OTHER Hospira, Inc. WATER 1 mL/mL 0409-1593_96fa446d-d34d-4ea7-9f09-b34ffe0f9bf6 0409-1593 HUMAN PRESCRIPTION DRUG THAM TROMETHAMINE INJECTION, SOLUTION INTRAVENOUS 20091116 NDA NDA013025 Hospira, Inc. TROMETHAMINE 3.6 g/100mL 0409-1610_94b18666-79b1-4baf-a9ba-be34b8066075 0409-1610 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 20090909 NDA NDA016694 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1623_d20a679a-6d7c-4604-b864-c0a11b86805d 0409-1623 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate Butorphanol Tartrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970123 ANDA ANDA074626 Hospira, Inc. BUTORPHANOL TARTRATE 1 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV 0409-1626_d20a679a-6d7c-4604-b864-c0a11b86805d 0409-1626 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate Butorphanol Tartrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970123 ANDA ANDA074626 Hospira, Inc. BUTORPHANOL TARTRATE 2 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV 0409-1630_12a8b31c-fd3e-4f2c-999b-9cc83cc6932f 0409-1630 HUMAN PRESCRIPTION DRUG Atropine Sulfate ATROPINE SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110629 NDA NDA021146 Hospira, Inc. ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0409-1631_0b2d8ec5-34d5-4cf1-b3dc-2621d5124683 0409-1631 HUMAN PRESCRIPTION DRUG Calcium Chloride CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110309 NDA NDA021117 Hospira, Inc. CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0409-1632_ffada524-1dcd-486c-ade7-b0336696eb8a 0409-1632 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19991021 ANDA ANDA075164 Hospira, Inc. VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0409-1634_ffada524-1dcd-486c-ade7-b0336696eb8a 0409-1634 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19991021 ANDA ANDA075164 Hospira, Inc. VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0409-1638_d704e5b6-e439-44ca-b4ad-fe5c83cc4313 0409-1638 HUMAN PRESCRIPTION DRUG Precedex DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19991217 NDA NDA021038 Hospira, Inc. DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] 0409-1639_3349611a-e8fd-436d-88e9-d16ee20fd57b 0409-1639 HUMAN PRESCRIPTION DRUG Furosemide FUROSEMIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19990528 ANDA ANDA075241 Hospira, Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0409-1660_d704e5b6-e439-44ca-b4ad-fe5c83cc4313 0409-1660 HUMAN PRESCRIPTION DRUG Precedex DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20130313 NDA NDA021038 Hospira, Inc. DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] 0409-1746_94b18666-79b1-4baf-a9ba-be34b8066075 0409-1746 HUMAN PRESCRIPTION DRUG Marcaine with Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20100506 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; .0091 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-1749_94b18666-79b1-4baf-a9ba-be34b8066075 0409-1749 HUMAN PRESCRIPTION DRUG Marcaine with Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20100510 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 5; .0091 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-1752_94b18666-79b1-4baf-a9ba-be34b8066075 0409-1752 HUMAN PRESCRIPTION DRUG Marcaine with Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION 20100506 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; .0091 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-1754_499148c8-8874-466c-bda4-c1caebcfbeab 0409-1754 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000425 ANDA ANDA075151 Hospira, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-1755_94b18666-79b1-4baf-a9ba-be34b8066075 0409-1755 HUMAN PRESCRIPTION DRUG Marcaine with Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION 20100510 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 5; .0091 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-1761_8b2f4a64-d655-4968-9b2b-3a3e23f35e52 0409-1761 HUMAN PRESCRIPTION DRUG Marcaine Spinal BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION SUBARACHNOID 19840504 NDA NDA018692 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-1775_f68ace11-1801-4576-b63e-57a1cffebade 0409-1775 HUMAN PRESCRIPTION DRUG Dextrose Dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 20101013 NDA NDA019445 Hospira, Inc. DEXTROSE MONOHYDRATE 250 mg/mL 0409-1778_2c9a3bf7-1784-4181-a1b1-0a9806d55789 0409-1778 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate METOPROLOL TARTRATE INJECTION, SOLUTION INTRAVENOUS 19931221 ANDA ANDA074133 Hospira, Inc. METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0409-1778_91f83fba-0d1f-46b6-bc52-e37cb9a86a10 0409-1778 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate METOPROLOL TARTRATE INJECTION, SOLUTION INTRAVENOUS 20080429 ANDA ANDA078085 Hospira, Inc. METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0409-1782_29058a27-d2de-464a-94bb-328e039b8595 0409-1782 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19860924 ANDA ANDA070172 Hospira, Inc. NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 0409-1844_04b97a7b-2db8-4ba2-80ee-82ac50709985 0409-1844 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110217 ANDA ANDA089744 Hospira, Inc. PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0409-1849_5e38556c-d132-4126-a2ac-4ba87921503f 0409-1849 HUMAN PRESCRIPTION DRUG Niphanoid TETRACAINE HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION SUBARACHNOID 19970609 UNAPPROVED DRUG OTHER Hospira, Inc. TETRACAINE HYDROCHLORIDE 10 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 0409-1886_35955ba9-1f0a-4c5f-9e2a-a1ff06dd69f1 0409-1886 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM INJECTION INTRAVENOUS 20120406 ANDA ANDA202869 Hospira, Inc. LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0409-1890_f6069b31-f23d-422d-a56b-3c0eb9e43460 0409-1890 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20111114 NDA NDA202515 Hospira, Inc. MORPHINE SULFATE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1891_f6069b31-f23d-422d-a56b-3c0eb9e43460 0409-1891 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20111114 NDA NDA202515 Hospira, Inc. MORPHINE SULFATE 4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1892_f6069b31-f23d-422d-a56b-3c0eb9e43460 0409-1892 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20111114 NDA NDA202515 Hospira, Inc. MORPHINE SULFATE 8 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1893_f6069b31-f23d-422d-a56b-3c0eb9e43460 0409-1893 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20111114 NDA NDA202515 Hospira, Inc. MORPHINE SULFATE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1894_f6069b31-f23d-422d-a56b-3c0eb9e43460 0409-1894 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20111114 NDA NDA202515 Hospira, Inc. MORPHINE SULFATE 15 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-1902_752f6c6f-3ce0-4c26-b1f4-48e3df74d12b 0409-1902 HUMAN PRESCRIPTION DRUG Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19860212 ANDA ANDA089069 Hospira, Inc. PROCAINAMIDE HYDROCHLORIDE 100 mg/mL Antiarrhythmic [EPC] 0409-1902_c962cdfd-1695-48d0-8b58-122dce35b624 0409-1902 HUMAN PRESCRIPTION DRUG Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140701 ANDA ANDA089069 Hospira, Inc. PROCAINAMIDE HYDROCHLORIDE 100 mg/mL Antiarrhythmic [EPC] 0409-1903_752f6c6f-3ce0-4c26-b1f4-48e3df74d12b 0409-1903 HUMAN PRESCRIPTION DRUG Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19860212 ANDA ANDA089070 Hospira, Inc. PROCAINAMIDE HYDROCHLORIDE 500 mg/mL Antiarrhythmic [EPC] 0409-1903_c962cdfd-1695-48d0-8b58-122dce35b624 0409-1903 HUMAN PRESCRIPTION DRUG Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140701 ANDA ANDA089070 Hospira, Inc. PROCAINAMIDE HYDROCHLORIDE 500 mg/mL Antiarrhythmic [EPC] 0409-1918_b405426e-67be-4984-96a6-8e0372f64fa8 0409-1918 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110913 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM CHLORIDE 9 mg/mL 0409-1920_c3bb60eb-9f59-4720-8245-853a2a34d2f8 0409-1920 HUMAN PRESCRIPTION DRUG Talwin PENTAZOCINE LACTATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20101012 NDA NDA016194 Hospira, Inc. PENTAZOCINE LACTATE 30 mg/mL Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV 0409-1932_afea6ebb-c2f0-4d3c-9f77-f9b0f6723451 0409-1932 HUMAN PRESCRIPTION DRUG Adenosine ADENOSINE INJECTION, SOLUTION INTRAVENOUS 20140324 ANDA ANDA203883 Hospira, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 0409-1933_a3ebe7ce-f059-4207-b846-5bbaf513323b 0409-1933 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20131125 ANDA ANDA203885 Hospira, Inc. AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0409-1934_a3ebe7ce-f059-4207-b846-5bbaf513323b 0409-1934 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20131125 ANDA ANDA203884 Hospira, Inc. AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0409-1941_c3bb60eb-9f59-4720-8245-853a2a34d2f8 0409-1941 HUMAN PRESCRIPTION DRUG Talwin PENTAZOCINE LACTATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20101012 NDA NDA016194 Hospira, Inc. PENTAZOCINE LACTATE 30 mg/mL Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV 0409-1966_4906b8ff-7010-4716-b7b7-020355c78007 0409-1966 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION INTRAVENOUS 19821029 NDA NDA018800 Hospira, Inc. SODIUM CHLORIDE 9 mg/mL 0409-1985_8aed9b3e-3849-4454-a7a9-1760b8f96894 0409-1985 HUMAN PRESCRIPTION DRUG Lorazepam LORAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110526 ANDA ANDA074243 Hospira, Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-1985_b4269d19-18ba-49d7-82bc-b23ab23989ae 0409-1985 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110425 ANDA ANDA074243 Hospira, Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-2012_b995d55b-e827-4650-8462-31da5ebfd1e2 0409-2012 HUMAN PRESCRIPTION DRUG Buprenorphine Hydrochloride Buprenorphine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100712 ANDA ANDA074137 Hospira, Inc. BUPRENORPHINE HYDROCHLORIDE .3 mg/mL Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 0409-2025_258d470b-d59d-4796-9d0f-173f96b64536 0409-2025 HUMAN PRESCRIPTION DRUG DOBUTamine DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19950216 ANDA ANDA074292 Hospira, Inc. DOBUTAMINE HYDROCHLORIDE 12.5 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 0409-2028_ff409c7c-00c5-462b-9da5-bc32db826537 0409-2028 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAVENOUS 19921030 NDA NDA019917 Hospira, Inc. MORPHINE SULFATE .5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-2029_ff409c7c-00c5-462b-9da5-bc32db826537 0409-2029 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAVENOUS 19921030 NDA NDA019916 Hospira, Inc. MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-2047_464cee15-0d9a-446d-9453-dd9deca4e13f 0409-2047 HUMAN PRESCRIPTION DRUG Carbocaine Mepivacaine Hydrochloride INJECTION, SOLUTION INFILTRATION 20100308 NDA NDA012250 Hospira, Inc. MEPIVACAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-2051_4e68bd8f-743c-471d-8211-f4ffac655eb5 0409-2051 HUMAN PRESCRIPTION DRUG Ketamine Hydrochloride KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAMUSCULAR; INTRAVENOUS 19960627 ANDA ANDA074549 Hospira, Inc. KETAMINE HYDROCHLORIDE 100 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII 0409-2053_4e68bd8f-743c-471d-8211-f4ffac655eb5 0409-2053 HUMAN PRESCRIPTION DRUG Ketamine Hydrochloride KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAMUSCULAR; INTRAVENOUS 19960627 ANDA ANDA074549 Hospira, Inc. KETAMINE HYDROCHLORIDE 50 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII 0409-2066_3f59cb2a-0e7f-4c37-9ab9-cc8b56efdddd 0409-2066 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION 20091117 ANDA ANDA040078 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-2102_8560f77a-519f-4486-a384-86e9d16f805e 0409-2102 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20111011 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM CHLORIDE 9 mg/mL 0409-2122_91efc458-cba5-4145-9f01-047330ec5de7 0409-2122 HUMAN PRESCRIPTION DRUG ENALAPRILAT ENALAPRILAT INJECTION, SOLUTION INTRAVENOUS 20000822 ANDA ANDA075458 Hospira, Inc. ENALAPRILAT 1.25 mg/mL Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0409-2122_f676ede3-d5c9-4e2f-b601-78b6eac048ca 0409-2122 HUMAN PRESCRIPTION DRUG Enalaprilat ENALAPRILAT INJECTION, SOLUTION INTRAVENOUS 20050430 ANDA ANDA075458 Hospira, Inc. ENALAPRILAT 1.25 mg/mL Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0409-2168_ad6c179e-75bf-45df-8adc-581ce7dd41c6 0409-2168 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041031 UNAPPROVED DRUG OTHER Hospira, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-2265_72245812-5df9-43dd-bcc6-91ded8d829a4 0409-2265 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20000828 ANDA ANDA075220 Hospira, Inc. DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 0409-2266_1a0213ed-cae0-47c3-bf5b-5e8412fc4a43 0409-2266 HUMAN PRESCRIPTION DRUG ALFENTANIL HYDROCHLORIDE ALFENTANIL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050830 ANDA ANDA075221 Hospira, Inc. ALFENTANIL HYDROCHLORIDE 500 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-2266_8802281c-1e57-451c-8e1e-dfd9b9459205 0409-2266 HUMAN PRESCRIPTION DRUG alfentanil hydrochloride alfentanil hydrochloride INJECTION, SOLUTION INTRAVENOUS 19991028 ANDA ANDA075221 Hospira, Inc. ALFENTANIL HYDROCHLORIDE 500 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-2267_4e1bfdde-fe5c-426e-be80-e0c7b040413f 0409-2267 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130722 ANDA ANDA075240 Hospira, Inc. LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0409-2267_b50eaa5b-ff85-43cb-a171-5ce3e1ec4840 0409-2267 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19991129 ANDA ANDA075240 Hospira, Inc. LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0409-2285_2c9a3bf7-1784-4181-a1b1-0a9806d55789 0409-2285 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate METOPROLOL TARTRATE INJECTION, SOLUTION INTRAVENOUS 19980706 ANDA ANDA075160 Hospira, Inc. METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0409-2287_7759de3a-bb46-4540-bf8f-8d1a33f62861 0409-2287 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19990127 ANDA ANDA074993 Hospira, Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0409-2287_d6ba0bc7-b6a9-4c83-86a1-5c8e7b45609f 0409-2287 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120430 ANDA ANDA074993 Hospira, Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0409-2287_fb0ac89e-e4bd-4c81-b684-5d85a9951ef7 0409-2287 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19990127 ANDA ANDA074993 Hospira, Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0409-2288_7759de3a-bb46-4540-bf8f-8d1a33f62861 0409-2288 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19990127 ANDA ANDA074993 Hospira, Inc. KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0409-2288_fb0ac89e-e4bd-4c81-b684-5d85a9951ef7 0409-2288 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19990127 ANDA ANDA074993 Hospira, Inc. KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0409-2290_4db06176-5f00-4914-beca-11eee9995b4f 0409-2290 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19981120 ANDA ANDA040140 Hospira, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0409-2290_c53ee4fa-f902-4998-8ab1-00522bb88f02 0409-2290 HUMAN PRESCRIPTION DRUG DiphenhydrAMINE Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19881120 ANDA ANDA040140 Hospira, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0409-2304_43495dfa-4cec-4ce4-bd61-e08a58845786 0409-2304 HUMAN PRESCRIPTION DRUG Corlopam FENOLDOPAM MESYLATE INJECTION, SOLUTION INTRAVENOUS 19970923 NDA NDA019922 Hospira, Inc. FENOLDOPAM MESYLATE 10 mg/mL Dopamine Agonists [MoA],Dopaminergic Agonist [EPC] 0409-2305_c80f6ee5-8058-47f9-a0e9-fb5bbf152806 0409-2305 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020722 ANDA ANDA075857 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-2306_023ab7e2-8d9c-4b80-8b63-5a4dd51d363c 0409-2306 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020613 ANDA ANDA075856 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-2306_3f3ed66a-25c0-4c45-bacc-af3fca2a019b 0409-2306 HUMAN PRESCRIPTION DRUG MIDAZOLAM Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020613 ANDA ANDA075856 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-2306_cdeddab6-b3c5-4c1a-a7ea-af1cd0322984 0409-2306 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020613 ANDA ANDA075856 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-2307_023ab7e2-8d9c-4b80-8b63-5a4dd51d363c 0409-2307 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020613 ANDA ANDA075856 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-2307_3f3ed66a-25c0-4c45-bacc-af3fca2a019b 0409-2307 HUMAN PRESCRIPTION DRUG MIDAZOLAM Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020613 ANDA ANDA075856 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-2308_c80f6ee5-8058-47f9-a0e9-fb5bbf152806 0409-2308 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020722 ANDA ANDA075857 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-2312_5e5c85ea-090f-4004-a34c-1c2d9927899e 0409-2312 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091001 ANDA ANDA040372 Hospira, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0409-2312_c3811392-37b8-4e08-a64a-be31c3296c00 0409-2312 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091001 ANDA ANDA040372 Hospira, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0409-2336_6a317138-57a0-4e9a-b651-f0bdd9b0b119 0409-2336 HUMAN PRESCRIPTION DRUG Deferoxamine Mesylate Deferoxamine Mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20040317 ANDA ANDA076019 Hospira, Inc. DEFEROXAMINE MESYLATE 500 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC] 0409-2336_885bedac-c608-4478-aa37-a3e39d03c2c2 0409-2336 HUMAN PRESCRIPTION DRUG Deferoxamine Mesylate Deferoxamine Mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20040317 ANDA ANDA076019 Hospira, Inc. DEFEROXAMINE MESYLATE 500 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC] 0409-2337_6a317138-57a0-4e9a-b651-f0bdd9b0b119 0409-2337 HUMAN PRESCRIPTION DRUG Deferoxamine Mesylate Deferoxamine Mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20040317 ANDA ANDA076019 Hospira, Inc. DEFEROXAMINE MESYLATE 2 g/1 Iron Chelating Activity [MoA],Iron Chelator [EPC] 0409-2337_885bedac-c608-4478-aa37-a3e39d03c2c2 0409-2337 HUMAN PRESCRIPTION DRUG Deferoxamine Mesylate Deferoxamine Mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20040317 ANDA ANDA076019 Hospira, Inc. DEFEROXAMINE MESYLATE 2 g/1 Iron Chelating Activity [MoA],Iron Chelator [EPC] 0409-2339_e8ca5017-fc03-48f7-846d-fcfd2f847f79 0409-2339 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19991129 ANDA ANDA075239 Hospira, Inc. LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0409-2344_332bd47c-f034-40ca-a805-81a8ccb6e079 0409-2344 HUMAN PRESCRIPTION DRUG DOBUTAMINE HYDROCHLORIDE DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19931129 ANDA ANDA074086 Hospira, Inc. DOBUTAMINE HYDROCHLORIDE 12.5 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 0409-2346_5a4866e8-7931-41ef-907b-dd9fc789ae9e 0409-2346 HUMAN PRESCRIPTION DRUG DOBUTamine Hydrochloride in Dextrose DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19931019 NDA NDA020201 Hospira, Inc. DOBUTAMINE HYDROCHLORIDE 100 mg/100mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 0409-2347_5a4866e8-7931-41ef-907b-dd9fc789ae9e 0409-2347 HUMAN PRESCRIPTION DRUG DOBUTamine Hydrochloride in Dextrose DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19931019 NDA NDA020201 Hospira, Inc. DOBUTAMINE HYDROCHLORIDE 200 mg/100mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 0409-2540_ba33d896-0954-41e7-bc4f-462d84b1c726 0409-2540 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20111201 NDA NDA200403 Hospira, Inc. HYDROMORPHONE HYDROCHLORIDE 4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-2552_ba33d896-0954-41e7-bc4f-462d84b1c726 0409-2552 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20111201 NDA NDA200403 Hospira, Inc. HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-2581_b16799af-9280-4963-a139-2b45e8d92529 0409-2581 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20101022 NDA NDA005264 Hospira, Inc. HEPARIN SODIUM 10000 [USP'U]/5mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0409-2584_b16799af-9280-4963-a139-2b45e8d92529 0409-2584 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20101022 NDA NDA005264 Hospira, Inc. HEPARIN SODIUM 25000 [USP'U]/10mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0409-2585_7823b7c5-e711-4dd1-8983-7a2eee5e1ea8 0409-2585 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20070509 ANDA ANDA065345 Hospira, Inc CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-2587_f1d4ae52-682e-4264-9556-ef698f1f3a6f 0409-2587 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075293 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-2596_f1d4ae52-682e-4264-9556-ef698f1f3a6f 0409-2596 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075293 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-2634_154a588a-67dd-4196-8efd-80b529f2b5df 0409-2634 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100819 ANDA ANDA078591 Hospira, Inc. HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-2687_028303e5-40c8-49a7-be82-6c1e7ddc0e55 0409-2687 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam AMPICILLIN and SULBACTAM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120319 ANDA ANDA090646 Hospira, Inc. AMPICILLIN SODIUM; SULBACTAM SODIUM 100; 50 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0409-2687_18c58847-002b-4f47-96e1-7e897ee474c0 0409-2687 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060725 ANDA ANDA065240 Hospira, Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 100; 50 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0409-2689_a0b00a9d-3a58-4a21-8a04-5847d782424a 0409-2689 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and Sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060725 ANDA ANDA065241 Hospira, Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0409-2689_a607e3dd-7917-4c52-9a78-1b7ac7529f5a 0409-2689 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and Sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060725 ANDA ANDA065241 Hospira, Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0409-2720_6e91ecc8-de13-406f-b290-0064213af43c 0409-2720 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20090831 ANDA ANDA090571 Hospira, Inc. HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0409-2721_6e91ecc8-de13-406f-b290-0064213af43c 0409-2721 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20090831 ANDA ANDA090571 Hospira, Inc. HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0409-2723_6e91ecc8-de13-406f-b290-0064213af43c 0409-2723 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20090831 ANDA ANDA090571 Hospira, Inc. HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0409-2776_360511f1-ed46-4cc4-a5f5-cf786ceb0226 0409-2776 HUMAN PRESCRIPTION DRUG Milrinone Lactate Milrinone Lactate INJECTION, SOLUTION INTRAVENOUS 20020528 ANDA ANDA075885 Hospira, Inc. MILRINONE LACTATE 200 ug/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0409-2987_a0b00a9d-3a58-4a21-8a04-5847d782424a 0409-2987 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and Sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060725 ANDA ANDA065241 Hospira, Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0409-2987_a607e3dd-7917-4c52-9a78-1b7ac7529f5a 0409-2987 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and Sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060725 ANDA ANDA065241 Hospira, Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0409-2988_35be7f5f-663f-4aa5-899b-c61ebb9797ca 0409-2988 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam AMPICILLIN SODIUM and SULBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120319 ANDA ANDA090375 Hospira, Inc. AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0409-2988_68fc67a6-7d56-4467-afc3-d8f6d29f03a7 0409-2988 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and Sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060725 ANDA ANDA065241 Hospira, Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0409-2988_97a749c7-ee40-48bb-9477-ee5825783ccc 0409-2988 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam AMPICILLIN and SULBACTAM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120319 ANDA ANDA090653 Hospira, Inc. AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0409-2998_35be7f5f-663f-4aa5-899b-c61ebb9797ca 0409-2998 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam AMPICILLIN SODIUM and SULBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120319 ANDA ANDA090375 Hospira, Inc. AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0409-2998_68fc67a6-7d56-4467-afc3-d8f6d29f03a7 0409-2998 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and Sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060725 ANDA ANDA065241 Hospira, Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0409-2998_97a749c7-ee40-48bb-9477-ee5825783ccc 0409-2998 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam AMPICILLIN and SULBACTAM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120319 ANDA ANDA090653 Hospira, Inc. AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0409-3024_d6c6e333-fcf4-49b7-a4a6-baae41c8d1ab 0409-3024 HUMAN PRESCRIPTION DRUG NITROPRESS SODIUM NITROPRUSSIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19880801 ANDA ANDA071961 Hospira, Inc. SODIUM NITROPRUSSIDE 50 mg/2mL 0409-3073_e4da6d0c-df90-41d3-8a24-24bcc2a0076a 0409-3073 HUMAN PRESCRIPTION DRUG Ephedrine EPHEDRINE SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050908 UNAPPROVED DRUG OTHER Hospira, Inc. EPHEDRINE SULFATE 50 mg/mL 0409-3177_34026e93-65f9-4473-a1f2-bd75339c805c 0409-3177 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 19880621 ANDA ANDA089635 Hospira, Inc. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 5; 5 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-3178_34026e93-65f9-4473-a1f2-bd75339c805c 0409-3178 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 19880621 ANDA ANDA089644 Hospira, Inc. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 10; 10 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-3181_34026e93-65f9-4473-a1f2-bd75339c805c 0409-3181 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE and EPINEPHRINE INJECTION, SOLUTION EPIDURAL; INFILTRATION 19880621 ANDA ANDA089645 Hospira, Inc. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 5; 15 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-3182_34026e93-65f9-4473-a1f2-bd75339c805c 0409-3182 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 19880621 ANDA ANDA089646 Hospira, Inc. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 10; 20 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-3183_34026e93-65f9-4473-a1f2-bd75339c805c 0409-3183 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE and EPINEPHRINE INJECTION, SOLUTION EPIDURAL; INFILTRATION 19880621 ANDA ANDA089651 Hospira, Inc. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 5; 20 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-3213_0d44b53d-1a51-42a2-8b7c-f6c4e3ee2a4f 0409-3213 HUMAN PRESCRIPTION DRUG Diazepam DIAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19871013 ANDA ANDA071583 Hospira, Inc. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-3213_5fdba855-ef26-4d5c-a126-ff306f3768a1 0409-3213 HUMAN PRESCRIPTION DRUG Diazepam DIAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19871013 ANDA ANDA071583 Hospira, Inc. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-3213_ec367398-9bf1-45b2-86a9-1aa1a2937adf 0409-3213 HUMAN PRESCRIPTION DRUG Diazepam DIAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19871013 ANDA ANDA071583 Hospira, Inc. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-3217_9009ea50-f82e-48fe-82b0-aa5182c55a59 0409-3217 HUMAN PRESCRIPTION DRUG A-METHAPRED METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051220 ANDA ANDA040664 Hospira, Inc. METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0409-3218_9009ea50-f82e-48fe-82b0-aa5182c55a59 0409-3218 HUMAN PRESCRIPTION DRUG A-METHAPRED METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051220 ANDA ANDA040665 Hospira, Inc. METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0409-3294_3a51e6f4-3162-40ce-b901-90485be1155a 0409-3294 HUMAN PRESCRIPTION DRUG Potassium Acetate POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19840720 NDA NDA018896 Hospira, Inc. POTASSIUM ACETATE 196.3 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-3294_8ea2d081-123e-4f82-9b25-22f867605d9e 0409-3294 HUMAN PRESCRIPTION DRUG Potassium Acetate POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100408 NDA NDA018896 Hospira, Inc. POTASSIUM ACETATE 196.3 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-3299_c3be2468-45e8-4ecc-a30b-e966743a563f 0409-3299 HUMAN PRESCRIPTION DRUG Sodium Acetate Sodium Acetate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20131119 NDA NDA018893 Hospira, Inc. SODIUM ACETATE ANHYDROUS 164 mg/mL 0409-3299_fbc671e8-95bc-445a-8023-ad5429e86958 0409-3299 HUMAN PRESCRIPTION DRUG Sodium Acetate SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20050430 NDA NDA018893 Hospira, Inc. SODIUM ACETATE ANHYDROUS 164 mg/mL 0409-3307_72d54872-8c94-4f95-a980-b66478320c48 0409-3307 HUMAN PRESCRIPTION DRUG Acetylcysteine ACETYLCYSTEINE SOLUTION ORAL; RESPIRATORY (INHALATION) 19940830 ANDA ANDA073664 Hospira, Inc. ACETYLCYSTEINE 100 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 0409-3308_72d54872-8c94-4f95-a980-b66478320c48 0409-3308 HUMAN PRESCRIPTION DRUG Acetylcysteine ACETYLCYSTEINE SOLUTION ORAL; RESPIRATORY (INHALATION) 19940830 ANDA ANDA074037 Hospira, Inc. ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 0409-3356_ba33d896-0954-41e7-bc4f-462d84b1c726 0409-3356 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20111201 NDA NDA200403 Hospira, Inc. HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-3365_ba33d896-0954-41e7-bc4f-462d84b1c726 0409-3365 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20111201 NDA NDA200403 Hospira, Inc. HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-3373_677d0dc0-7942-4c4b-944d-6213833c368a 0409-3373 HUMAN PRESCRIPTION DRUG Corlopam FENOLDOPAM MESYLATE INJECTION, SOLUTION INTRAVENOUS 20110907 NDA NDA019922 Hospira, Inc. FENOLDOPAM MESYLATE 10 mg/mL Dopamine Agonists [MoA],Dopaminergic Agonist [EPC] 0409-3374_81722095-1564-4abb-ace4-88e4f6cee117 0409-3374 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065363 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0409-3374_f49ccb9a-1229-4bf7-9f51-d05ef538f832 0409-3374 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065363 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0409-3375_683cb843-1c53-4076-9ce2-eefff8d0b149 0409-3375 HUMAN PRESCRIPTION DRUG LEVOPHED NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19500713 NDA NDA007513 Hospira, Inc. NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-3375_6de87310-ce59-4c09-8ae9-954f4ac1e9db 0409-3375 HUMAN PRESCRIPTION DRUG LEVOPHED NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19500713 NDA NDA007513 Hospira, Inc. NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-3378_81722095-1564-4abb-ace4-88e4f6cee117 0409-3378 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065363 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0409-3378_f49ccb9a-1229-4bf7-9f51-d05ef538f832 0409-3378 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065363 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0409-3379_81722095-1564-4abb-ace4-88e4f6cee117 0409-3379 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065363 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0409-3379_f49ccb9a-1229-4bf7-9f51-d05ef538f832 0409-3379 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065363 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0409-3380_6134a6f1-3aac-47d3-bcaf-244e04405925 0409-3380 HUMAN PRESCRIPTION DRUG Sufentanil Citrate SUFENTANIL CITRATE INJECTION, SOLUTION EPIDURAL; INTRAVENOUS 20111011 ANDA ANDA074534 Hospira, Inc. SUFENTANIL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-3382_6134a6f1-3aac-47d3-bcaf-244e04405925 0409-3382 HUMAN PRESCRIPTION DRUG Sufentanil Citrate SUFENTANIL CITRATE INJECTION, SOLUTION EPIDURAL; INTRAVENOUS 20111011 ANDA ANDA074534 Hospira, Inc. SUFENTANIL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-3383_3b50ab70-8955-4556-b2cc-6cc4ccc52730 0409-3383 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065362 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0409-3383_67614022-b317-43e0-a52d-4c1e9e3f279d 0409-3383 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065362 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0409-3385_3b50ab70-8955-4556-b2cc-6cc4ccc52730 0409-3385 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065362 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0409-3385_67614022-b317-43e0-a52d-4c1e9e3f279d 0409-3385 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065362 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0409-3390_3b50ab70-8955-4556-b2cc-6cc4ccc52730 0409-3390 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065362 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0409-3390_67614022-b317-43e0-a52d-4c1e9e3f279d 0409-3390 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065362 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0409-3400_b73f7d63-8035-40bc-8b81-04ff67968d06 0409-3400 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20111130 ANDA ANDA062612 Hospira, Inc. GENTAMICIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0409-3401_b73f7d63-8035-40bc-8b81-04ff67968d06 0409-3401 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20111130 ANDA ANDA062612 Hospira, Inc. GENTAMICIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0409-3402_b73f7d63-8035-40bc-8b81-04ff67968d06 0409-3402 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20111130 ANDA ANDA062612 Hospira, Inc. GENTAMICIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0409-3414_a8f23a7b-c6bf-4751-9593-52b856bd7206 0409-3414 HUMAN PRESCRIPTION DRUG Metoclopramide METOCLOPRAMIDE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19910117 ANDA ANDA073118 Hospira, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0409-3470_93fb3822-7251-4d68-9189-75be9a177324 0409-3470 HUMAN PRESCRIPTION DRUG Tobramycin in Sodium Chloride TOBRAMYCIN SULFATE INJECTION, SOLUTION INTRAVENOUS 19900731 ANDA ANDA063081 Hospira, Inc. TOBRAMYCIN SULFATE .8 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0409-3486_4a937e2c-0a3c-4b85-b9b7-c9df2650759c 0409-3486 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20120418 ANDA ANDA077394 Hospira, Inc. SODIUM BICARBONATE 75 mg/mL 0409-3495_4a937e2c-0a3c-4b85-b9b7-c9df2650759c 0409-3495 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20120418 ANDA ANDA077394 Hospira, Inc. SODIUM BICARBONATE 84 mg/mL 0409-3505_6cd104ad-b6af-4621-8a96-7b8bd963876f 0409-3505 HUMAN PRESCRIPTION DRUG Meropenem MEROPENEM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100623 ANDA ANDA090940 Hospira, Inc. MEROPENEM 500 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 0409-3506_6cd104ad-b6af-4621-8a96-7b8bd963876f 0409-3506 HUMAN PRESCRIPTION DRUG Meropenem MEROPENEM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100623 ANDA ANDA090940 Hospira, Inc. MEROPENEM 1 g/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 0409-3507_0c08ec02-9a42-438e-a9aa-ad536d88d48b 0409-3507 HUMAN PRESCRIPTION DRUG Imipenem and Cilastatin IMIPENEM and CILASTATIN SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20111117 ANDA ANDA090825 Hospira, Inc. CILASTATIN SODIUM; IMIPENEM 500; 500 mg/100mL; mg/100mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 0409-3507_7acf7d76-6755-46c5-86d5-a1a74d8d1955 0409-3507 HUMAN PRESCRIPTION DRUG Imipenem and Cilastatin IMIPENEM and CILASTATIN SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20111117 ANDA ANDA090825 Hospira, Inc. CILASTATIN SODIUM; IMIPENEM 500; 500 mg/100mL; mg/100mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 0409-3507_dc524863-3daf-4be9-b51f-e57b0445b46d 0409-3507 HUMAN PRESCRIPTION DRUG Imipenem and Cilastatin IMIPENEM and CILASTATIN SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20111117 ANDA ANDA091007 Hospira, Inc. CILASTATIN SODIUM; IMIPENEM 500; 500 mg/100mL; mg/100mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 0409-3508_0c08ec02-9a42-438e-a9aa-ad536d88d48b 0409-3508 HUMAN PRESCRIPTION DRUG Imipenem and Cilastatin IMIPENEM and CILASTATIN SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20111117 ANDA ANDA090825 Hospira, Inc. CILASTATIN SODIUM; IMIPENEM 250; 250 mg/100mL; mg/100mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 0409-3508_7acf7d76-6755-46c5-86d5-a1a74d8d1955 0409-3508 HUMAN PRESCRIPTION DRUG Imipenem and Cilastatin IMIPENEM and CILASTATIN SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20111117 ANDA ANDA090825 Hospira, Inc. CILASTATIN SODIUM; IMIPENEM 250; 250 mg/100mL; mg/100mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 0409-3577_1ae57398-956c-4ff7-8d4d-23160579816c 0409-3577 HUMAN PRESCRIPTION DRUG Tobramycin TOBRAMYCIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19910430 ANDA ANDA063112 Hospira, Inc. TOBRAMYCIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0409-3578_1ae57398-956c-4ff7-8d4d-23160579816c 0409-3578 HUMAN PRESCRIPTION DRUG Tobramycin TOBRAMYCIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19910430 ANDA ANDA063111 Hospira, Inc. TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0409-3590_96fab241-e3f0-45ab-a198-affcf5978c59 0409-3590 HUMAN PRESCRIPTION DRUG Tobramycin TOBRAMYCIN SULFATE INJECTION, SOLUTION INTRAVENOUS 19920518 ANDA ANDA063116 Hospira, Inc. TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0409-3613_cbe78197-a58b-44ec-b1dd-b76dac6aef25 0409-3613 HUMAN PRESCRIPTION DRUG Bupivacaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION SUBARACHNOID 19871211 ANDA ANDA071810 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-3724_5a4866e8-7931-41ef-907b-dd9fc789ae9e 0409-3724 HUMAN PRESCRIPTION DRUG DOBUTamine Hydrochloride in Dextrose DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19931019 NDA NDA020201 Hospira, Inc. DOBUTAMINE HYDROCHLORIDE 400 mg/100mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 0409-3793_0084370a-8793-4cb8-bbc9-d58a8a345b86 0409-3793 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970605 ANDA ANDA074802 Hospira, Inc. KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0409-3793_0c5de268-3945-429c-9c3b-69dfb19344c1 0409-3793 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970605 ANDA ANDA074802 Hospira, Inc. KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0409-3795_0084370a-8793-4cb8-bbc9-d58a8a345b86 0409-3795 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970605 ANDA ANDA074802 Hospira, Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0409-3795_0c5de268-3945-429c-9c3b-69dfb19344c1 0409-3795 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970605 ANDA ANDA074802 Hospira, Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0409-3796_0084370a-8793-4cb8-bbc9-d58a8a345b86 0409-3796 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 19970605 ANDA ANDA074802 Hospira, Inc. KETOROLAC TROMETHAMINE 60 mg/2mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0409-3796_0c5de268-3945-429c-9c3b-69dfb19344c1 0409-3796 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 19970605 ANDA ANDA074802 Hospira, Inc. KETOROLAC TROMETHAMINE 60 mg/2mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0409-3814_aec1e167-f9f6-449c-a218-97f3a2a845fb 0409-3814 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION EPIDURAL; INTRATHECAL; INTRAVENOUS 19920930 ANDA ANDA073509 Hospira, Inc. MORPHINE SULFATE .5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-3815_aec1e167-f9f6-449c-a218-97f3a2a845fb 0409-3815 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION EPIDURAL; INTRATHECAL; INTRAVENOUS 19920930 ANDA ANDA073510 Hospira, Inc. MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-3863_2157608c-8ee3-4a95-b05e-71906b223b1f 0409-3863 HUMAN PRESCRIPTION DRUG Foscarnet Sodium Foscarnet Sodium INJECTION, SOLUTION INTRAVENOUS 20100707 ANDA ANDA077174 Hospira, Inc. FOSCARNET SODIUM 24 mg/mL DNA Polymerase Inhibitors [MoA],Pyrophosphate Analog [Chemical/Ingredient],Pyrophosphate Analog DNA Polymerase Inhibitor [EPC] 0409-3977_1326aa0c-252b-49f8-9598-429f61ddaba6 0409-3977 HUMAN PRESCRIPTION DRUG Bacteriostatic Water WATER INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19821027 NDA NDA018802 Hospira, Inc. WATER 1 mL/mL 0409-4011_e6213a51-c663-4cd4-bdf7-560e4f047d58 0409-4011 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19870506 ANDA ANDA070738 Hospira, Inc. VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0409-4031_b2afb88a-4b52-4b3d-a1e9-ad4b4383e91a 0409-4031 HUMAN PRESCRIPTION DRUG Mannitol MANNITOL INJECTION, SOLUTION INTRAVENOUS 19671222 NDA NDA016269 Hospira, Inc. MANNITOL 12.5 g/50mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 0409-4050_fcf173b5-fec9-47eb-851a-96ca975ed848 0409-4050 HUMAN PRESCRIPTION DRUG Clindamycin CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19870724 ANDA ANDA062800 Hospira, Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0409-4051_fcf173b5-fec9-47eb-851a-96ca975ed848 0409-4051 HUMAN PRESCRIPTION DRUG Clindamycin CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19870724 ANDA ANDA062800 Hospira, Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0409-4052_fcf173b5-fec9-47eb-851a-96ca975ed848 0409-4052 HUMAN PRESCRIPTION DRUG Clindamycin CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19870724 ANDA ANDA062800 Hospira, Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0409-4053_80cbe3d0-42f9-48cf-b9ce-178311f20862 0409-4053 HUMAN PRESCRIPTION DRUG Clindamycin CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19870724 ANDA ANDA062801 Hospira, Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0409-4054_80cbe3d0-42f9-48cf-b9ce-178311f20862 0409-4054 HUMAN PRESCRIPTION DRUG Clindamycin CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19870724 ANDA ANDA062801 Hospira, Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0409-4055_80cbe3d0-42f9-48cf-b9ce-178311f20862 0409-4055 HUMAN PRESCRIPTION DRUG Clindamycin CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19870724 ANDA ANDA062801 Hospira, Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0409-4056_0cc59b8b-e04d-40ec-9597-afb5f650f889 0409-4056 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 19720928 ANDA ANDA080408 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 15 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-4057_aec1e167-f9f6-449c-a218-97f3a2a845fb 0409-4057 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION EPIDURAL; INTRATHECAL; INTRAVENOUS 19880511 ANDA ANDA071849 Hospira, Inc. MORPHINE SULFATE .5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-4058_aec1e167-f9f6-449c-a218-97f3a2a845fb 0409-4058 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION EPIDURAL; INTRATHECAL; INTRAVENOUS 19880511 ANDA ANDA071850 Hospira, Inc. MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-4090_9e19eed8-24e8-45c3-82eb-420c11ca39f1 0409-4090 HUMAN PRESCRIPTION DRUG ZINC ZINC CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19860626 NDA NDA018959 Hospira, Inc. ZINC CHLORIDE 1 mg/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 0409-4091_eb5ece66-7cf8-4e97-a834-e1ad21465384 0409-4091 HUMAN PRESCRIPTION DRUG MANGANESE MANGANESE CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19860626 NDA NDA018962 Hospira, Inc. MANGANESE CHLORIDE .1 mg/mL Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0409-4092_830d3311-f51e-48ab-818e-86195f0748a5 0409-4092 HUMAN PRESCRIPTION DRUG COPPER CUPRIC CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19860626 NDA NDA018960 Hospira, Inc. CUPRIC CHLORIDE .4 mg/mL 0409-4093_c1f81371-d0de-4b0b-ba11-79a736668e57 0409-4093 HUMAN PRESCRIPTION DRUG CHROMIUM CHROMIC CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19860626 NDA NDA018961 Hospira, Inc. CHROMIC CHLORIDE 4 ug/mL 0409-4142_488dd10f-6c54-433d-bdab-b64c290cdb7a 0409-4142 HUMAN PRESCRIPTION DRUG DOPamine Hydrochloride and Dextrose Dopamine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19810519 NDA NDA018132 Hospira, Inc. DOPAMINE HYDROCHLORIDE 160 mg/100mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-4160_87abe091-869c-4a19-a67c-0b5fdb518c98 0409-4160 HUMAN PRESCRIPTION DRUG Aminosyn II ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYL-TYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 19860403 NDA NDA019438 Hospira, Inc. ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; N-ACETYL-TYROSINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE 695; 713; 490; 517; 350; 210; 462; 700; 735; 120; 189; 209; 505; 371; 280; 140; 350 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0409-4162_87abe091-869c-4a19-a67c-0b5fdb518c98 0409-4162 HUMAN PRESCRIPTION DRUG Aminosyn II ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYL-TYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 19860403 NDA NDA019438 Hospira, Inc. ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; N-ACETYL-TYROSINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE 844; 865; 595; 627; 425; 255; 561; 850; 893; 146; 230; 253; 614; 450; 340; 170; 425 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0409-4164_87abe091-869c-4a19-a67c-0b5fdb518c98 0409-4164 HUMAN PRESCRIPTION DRUG Aminosyn II ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYL-TYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 19860403 NDA NDA019438 Hospira, Inc. ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; N-ACETYL-TYROSINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE 993; 1018; 700; 738; 500; 300; 660; 1000; 1050; 172; 270; 298; 722; 530; 400; 200; 500 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0409-4166_7106cc84-ca68-4b75-a5f2-e3682ecec1fe 0409-4166 HUMAN PRESCRIPTION DRUG Aminosyn RF ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ARGININE, and HISTIDINE INJECTION, SOLUTION INTRAVENOUS 20110218 NDA NDA018429 Hospira, Inc. ARGININE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE 600; 429; 462; 726; 535; 726; 726; 330; 165; 528 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL 0409-4168_2ab1b1d5-3dc8-4b14-8730-b21bc0f9c845 0409-4168 HUMAN PRESCRIPTION DRUG Aminosyn Isoleucine, Leucine, Lysine acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, And Glycine INJECTION, SOLUTION INTRAVENOUS 20100819 NDA NDA019374 Hospira, Inc. ALANINE; ARGININE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 660; 507; 660; 154; 789; 1576; 265; 206; 228; 448; 221; 272; 88; 33; 789 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0409-4169_eb70c3b3-2c80-4445-ba42-e985e20fac44 0409-4169 HUMAN PRESCRIPTION DRUG Chloroprocaine Hydrochloride CHLOROPROCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 19820416 ANDA ANDA087447 Hospira, Inc. CHLOROPROCAINE HYDROCHLORIDE 20 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 0409-4170_eb70c3b3-2c80-4445-ba42-e985e20fac44 0409-4170 HUMAN PRESCRIPTION DRUG Chloroprocaine Hydrochloride CHLOROPROCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 19820416 ANDA ANDA087446 Hospira, Inc. CHLOROPROCAINE HYDROCHLORIDE 30 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 0409-4171_4b15e7df-6ff7-4ff7-84b4-793ad3bda59b 0409-4171 HUMAN PRESCRIPTION DRUG Aminosyn II with Electrolytes ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, GLYCINE, VALINE, ASPARTIC ACID, N-ACETYL-TYROSINE, GLUTAMIC ACID, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19860403 NDA NDA019437 Hospira, Inc. ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM CHLORIDE; METHIONINE; N-ACETYL-TYROSINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; THREONINE; TRYPTOPHAN; VALINE 844; 865; 595; 627; 425; 255; 561; 850; 893; 102; 146; 230; 253; 492; 614; 450; 60; 425; 340; 170; 425 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-4178_1b15a302-faa0-41b3-b8f8-1f4966707211 0409-4178 HUMAN PRESCRIPTION DRUG Aminosyn-PF ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE INJECTION, SOLUTION INTRAVENOUS 19850906 NDA NDA019398 Hospira, Inc. ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 490; 861; 370; 576; 270; 220; 534; 831; 475; 125; 300; 570; 347; 50; 360; 125; 44; 452 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0409-4179_3b2644cf-39f2-4980-90a8-013e1e4f8c24 0409-4179 HUMAN PRESCRIPTION DRUG Aminosyn-PF ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE INJECTION, SOLUTION INTRAVENOUS 19861017 NDA NDA019492 Hospira, Inc. ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 698; 1227; 527; 820; 385; 312; 760; 1200; 677; 180; 427; 812; 495; 70; 512; 180; 44; 673 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0409-4187_dad76e26-0274-4501-abaf-216a4165a2ae 0409-4187 HUMAN PRESCRIPTION DRUG Aminosyn ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 20120306 NDA NDA017673 Hospira, Inc. ALANINE; ARGININE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 1100; 850; 1100; 260; 620; 810; 624; 340; 380; 750; 370; 460; 150; 44; 680 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0409-4191_dad76e26-0274-4501-abaf-216a4165a2ae 0409-4191 HUMAN PRESCRIPTION DRUG Aminosyn ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 20120306 NDA NDA017673 Hospira, Inc. ALANINE; ARGININE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 1280; 980; 1280; 300; 720; 940; 720; 400; 440; 860; 420; 520; 160; 44; 800 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0409-4192_87246041-7204-4de1-862f-856e646b37e5 0409-4192 HUMAN PRESCRIPTION DRUG Aminosyn Sulfite Free ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 20111027 NDA NDA017673 Hospira, Inc. ALANINE; ARGININE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 1280; 980; 1280; 300; 720; 940; 720; 400; 440; 860; 420; 520; 160; 44; 800 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0409-4196_3d4922c0-c757-4756-88b0-c02ce8a66743 0409-4196 HUMAN PRESCRIPTION DRUG Aminosyn ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, GLYCINE, SODIUM CHLORIDE, POTASSIUM ACETATE, PHOSPHORIC ACID, and MAGNESIUM ACETATE INJECTION, SOLUTION INTRAVENOUS 20110323 NDA NDA017789 Hospira, Inc. ALANINE; ARGININE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM ACETATE; METHIONINE; PHENYLALANINE; PHOSPHORIC ACID; POTASSIUM ACETATE; PROLINE; SERINE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 448; 343; 448; 105; 252; 329; 252; 21; 140; 154; 40; 128; 300; 147; 234; 182; 56; 31; 280 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-4197_5088003c-c8fe-41f4-8d8d-2bb6ce831c5e 0409-4197 HUMAN PRESCRIPTION DRUG Clindamycin CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19880929 ANDA ANDA062943 Hospira, Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0409-4200_3d4922c0-c757-4756-88b0-c02ce8a66743 0409-4200 HUMAN PRESCRIPTION DRUG Aminosyn ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, GLYCINE, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110323 NDA NDA017789 Hospira, Inc. ALANINE; ARGININE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 900; 690; 900; 210; 510; 660; 510; 102; 280; 310; 487; 610; 300; 28; 425; 370; 120; 44; 560 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-4203_3d4922c0-c757-4756-88b0-c02ce8a66743 0409-4203 HUMAN PRESCRIPTION DRUG Aminosyn ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, GLYCINE, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110323 NDA NDA017673 Hospira, Inc. ALANINE; ARGININE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; MAGNESIUM CHLORIDE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 1100; 850; 1100; 260; 620; 810; 624; 102; 340; 380; 487; 750; 370; 28; 425; 460; 150; 44; 680 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0409-4265_feea1a53-bf24-4c1a-bdaa-5bf7b3f69b11 0409-4265 HUMAN PRESCRIPTION DRUG DOPamine Hydrochloride Dopamine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19810519 NDA NDA018132 Hospira, Inc. DOPAMINE HYDROCHLORIDE 80 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-4270_0cc59b8b-e04d-40ec-9597-afb5f650f889 0409-4270 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 19840517 ANDA ANDA088329 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-4272_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-4272 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 19780417 NDA NDA018053 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-4273_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-4273 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INTRACAUDAL 19780417 NDA NDA018053 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-4274_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-4274 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; RETROBULBAR 19780417 NDA NDA018053 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-4275_0cc59b8b-e04d-40ec-9597-afb5f650f889 0409-4275 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 19840731 ANDA ANDA088325 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-4276_0cc59b8b-e04d-40ec-9597-afb5f650f889 0409-4276 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 19840731 ANDA ANDA088299 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-4277_0cc59b8b-e04d-40ec-9597-afb5f650f889 0409-4277 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 19840731 ANDA ANDA088327 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-4278_0cc59b8b-e04d-40ec-9597-afb5f650f889 0409-4278 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; INTRAVENOUS 19840517 ANDA ANDA088328 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-4279_0cc59b8b-e04d-40ec-9597-afb5f650f889 0409-4279 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 19840517 ANDA ANDA088329 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-4282_0cc59b8b-e04d-40ec-9597-afb5f650f889 0409-4282 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 19840516 ANDA ANDA088294 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-4283_bc0f8dbd-4c20-47eb-876f-492cb9cb720d 0409-4283 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION RETROBULBAR; TOPICAL 19840516 ANDA ANDA088295 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-4332_3567d1c5-a226-46cf-b05d-b96d88f654c5 0409-4332 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19880804 ANDA ANDA062911 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0409-4332_a7956f63-2787-4c14-b817-0530622fceac 0409-4332 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19880804 ANDA ANDA062911 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0409-4346_307500dc-af9a-4f32-8e59-bf8b405e282f 0409-4346 HUMAN PRESCRIPTION DRUG Aminocaproic Acid AMINOCAPROIC ACID INJECTION, SOLUTION INTRAVENOUS 19870309 ANDA ANDA070010 Hospira, Inc. AMINOCAPROIC ACID 250 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 0409-4348_e1866cd5-d146-4866-90df-9e2c74325cd5 0409-4348 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20021018 ANDA ANDA075955 Hospira, Inc. AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0409-4350_6c7dc460-9a6a-4364-8bdc-0bef8fc36c37 0409-4350 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE POWDER, FOR SOLUTION INTRAVENOUS 20111020 ANDA ANDA075853 Hospira, Inc. DILTIAZEM HYDROCHLORIDE 100 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0409-4646_4f13a2e0-0fd3-4d27-b031-1c72f954d727 0409-4646 HUMAN PRESCRIPTION DRUG Pancuronium Bromide Pancuronium Bromide INJECTION, SOLUTION INTRAVENOUS 19890119 ANDA ANDA072320 Hospira, Inc. PANCURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0409-4684_31e9668d-c3ed-4a0b-8391-562ac45f2a4c 0409-4684 HUMAN PRESCRIPTION DRUG Fluconazole FLUCONAZOLE INJECTION, SOLUTION INTRAVENOUS 20040729 ANDA ANDA076304 Hospira, Inc. FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0409-4688_31e9668d-c3ed-4a0b-8391-562ac45f2a4c 0409-4688 HUMAN PRESCRIPTION DRUG Fluconazole FLUCONAZOLE INJECTION, SOLUTION INTRAVENOUS 20040729 ANDA ANDA076303 Hospira, Inc. FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0409-4699_37d715e6-ef7c-4597-a1d8-0507a3117764 0409-4699 HUMAN PRESCRIPTION DRUG PROPOFOL PROPOFOL INJECTION, EMULSION INTRAVENOUS 20060317 ANDA ANDA077908 Hospira, Inc. PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 0409-4712_65c33656-c67e-44ed-89d9-a9b2a146ddef 0409-4712 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Dextrose LIDOCAINE HYDROCHLORIDE and DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRASPINAL 19740123 ANDA ANDA083914 Hospira, Inc. DEXTROSE MONOHYDRATE; LIDOCAINE HYDROCHLORIDE 75; 50 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-4713_0cc59b8b-e04d-40ec-9597-afb5f650f889 0409-4713 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 19720928 ANDA ANDA080408 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-4755_5309c948-ff2f-440c-b23f-983c81b4026e 0409-4755 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077548 Hospira, Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0409-4759_5309c948-ff2f-440c-b23f-983c81b4026e 0409-4759 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077473 Hospira, Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0409-4765_c558792e-1b33-4c1b-b621-dcb26057105b 0409-4765 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060828 ANDA ANDA077245 Hospira, Inc. CIPROFLOXACIN 200 mg/20mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0409-4776_0cc59b8b-e04d-40ec-9597-afb5f650f889 0409-4776 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 19720928 ANDA ANDA080408 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 15 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-4777_7e67b5dc-57f4-4a74-b4d0-b8fcef926c7a 0409-4777 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN INJECTION, SOLUTION INTRAVENOUS 20080318 ANDA ANDA077753 Hospira, Inc. CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0409-4777_ef3995cc-4be2-4538-a8b0-1a925a432924 0409-4777 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN INJECTION, SOLUTION INTRAVENOUS 20080318 ANDA ANDA077753 Hospira, Inc. CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0409-4778_c558792e-1b33-4c1b-b621-dcb26057105b 0409-4778 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060828 ANDA ANDA077245 Hospira, Inc. CIPROFLOXACIN 400 mg/40mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0409-4856_0d257d21-5b42-45af-8bf5-c745d7bef226 0409-4856 HUMAN PRESCRIPTION DRUG A-HYDROCORT HYDROCORTISONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110512 ANDA ANDA040666 Hospira, Inc. HYDROCORTISONE SODIUM SUCCINATE 100 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0409-4857_c277eff2-c821-4214-af2c-c9db40b81e8a 0409-4857 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium FOSPHENYTOIN SODIUM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070806 ANDA ANDA078158 Hospira, Inc. FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0409-4887_749a1027-3916-447a-a8ae-74318944ffab 0409-4887 HUMAN PRESCRIPTION DRUG Sterile Water WATER INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19821027 NDA NDA018801 Hospira, Inc. 0409-4888_10bc8b42-50bf-4f09-a914-c9303c0348e4 0409-4888 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19821029 NDA NDA018803 Hospira, Inc. 0409-4900_0511096c-1897-458a-b643-e99664657916 0409-4900 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 19850501 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM BICARBONATE 84 mg/mL 0409-4901_67d56516-99f2-40ed-8704-538980b0a261 0409-4901 HUMAN PRESCRIPTION DRUG Epinephrine EPINEPHRINE INJECTION, SOLUTION ENDOTRACHEAL; INTRACARDIAC; INTRAVENOUS 19850501 UNAPPROVED DRUG OTHER Hospira, Inc. EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-4902_45add090-a517-4f6a-bd89-86922a233e9e 0409-4902 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER Hospira, Inc. DEXTROSE MONOHYDRATE 25 g/50mL 0409-4903_5912fa62-8d33-4c9f-bc4e-dc83f55a406f 0409-4903 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19721031 ANDA ANDA083158 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-4904_5912fa62-8d33-4c9f-bc4e-dc83f55a406f 0409-4904 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19721031 ANDA ANDA083158 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-4910_a1ab081f-2854-4847-b60e-2f428b329c45 0409-4910 HUMAN PRESCRIPTION DRUG Atropine Sulfate ATROPINE SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050825 UNAPPROVED DRUG OTHER Hospira, Inc. ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0409-4911_a1ab081f-2854-4847-b60e-2f428b329c45 0409-4911 HUMAN PRESCRIPTION DRUG Atropine Sulfate ATROPINE SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20051025 UNAPPROVED DRUG OTHER Hospira, Inc. ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0409-4916_0511096c-1897-458a-b643-e99664657916 0409-4916 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 19850214 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM BICARBONATE 75 mg/mL 0409-4921_67d56516-99f2-40ed-8704-538980b0a261 0409-4921 HUMAN PRESCRIPTION DRUG Epinephrine EPINEPHRINE INJECTION, SOLUTION ENDOTRACHEAL; INTRACARDIAC; INTRAVENOUS 19850405 UNAPPROVED DRUG OTHER Hospira, Inc. EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-4928_0feb325b-b587-4933-9aa6-91bcb6aca889 0409-4928 HUMAN PRESCRIPTION DRUG Calcium Chloride CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS; INTRAVENTRICULAR 19840917 UNAPPROVED DRUG OTHER Hospira, Inc. CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0409-5082_4fdc743e-f0fb-45b5-867d-f3bc38dd623e 0409-5082 HUMAN PRESCRIPTION DRUG TAZICEF CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19860306 ANDA ANDA062662 Hospira, Inc. CEFTAZIDIME 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-5084_4fdc743e-f0fb-45b5-867d-f3bc38dd623e 0409-5084 HUMAN PRESCRIPTION DRUG TAZICEF CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19860306 ANDA ANDA062662 Hospira, Inc. CEFTAZIDIME 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-5086_2fca6acb-f9a0-4aa2-951e-e9bed8ed5cc1 0409-5086 HUMAN PRESCRIPTION DRUG TAZICEF CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19860306 ANDA ANDA062662 Hospira, Inc. CEFTAZIDIME 6 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-5092_01ec5226-ccca-4ac0-86c6-5d4b9b57d73a 0409-5092 HUMAN PRESCRIPTION DRUG TAZICEF CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19931031 ANDA ANDA064032 Hospira, Inc. CEFTAZIDIME 20 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-5093_01ec5226-ccca-4ac0-86c6-5d4b9b57d73a 0409-5093 HUMAN PRESCRIPTION DRUG TAZICEF CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19931031 ANDA ANDA064032 Hospira, Inc. CEFTAZIDIME 40 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-5534_0511096c-1897-458a-b643-e99664657916 0409-5534 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 19840127 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM BICARBONATE 42 mg/mL 0409-5622_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-5622 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 19780417 NDA NDA018053 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-5623_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-5623 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; RETROBULBAR 19780417 NDA NDA018053 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-5757_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-5757 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 19780417 NDA NDA018053 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-5758_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-5758 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 19780417 NDA NDA018053 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-5779_e3bae709-c55c-42e2-9813-9db0c9630466 0409-5779 HUMAN PRESCRIPTION DRUG TPN Electrolytes SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, and SODIUM ACETATE ANHYDROUS INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19840720 NDA NDA018895 Hospira, Inc. CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM CHLORIDE 331; 508; 1491; 2420; 321 mg/20mL; mg/20mL; mg/20mL; mg/20mL; mg/20mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-5820_feea1a53-bf24-4c1a-bdaa-5bf7b3f69b11 0409-5820 HUMAN PRESCRIPTION DRUG DOPamine Hydrochloride Dopamine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19810519 NDA NDA018132 Hospira, Inc. DOPAMINE HYDROCHLORIDE 40 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-5921_ae346f72-d711-412a-a90c-3648e23beb7c 0409-5921 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline Dihydrate INJECTION, SOLUTION INTRAVENOUS 19831026 ANDA ANDA087242 Hospira, Inc. AMINOPHYLLINE DIHYDRATE 25 mg/mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0409-5921_b36d72fb-a0fb-4d3e-940b-97090dc8e7a0 0409-5921 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline Dihydrate INJECTION, SOLUTION INTRAVENOUS 19831026 ANDA ANDA087242 Hospira, Inc. AMINOPHYLLINE DIHYDRATE 25 mg/mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0409-5922_ae346f72-d711-412a-a90c-3648e23beb7c 0409-5922 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline Dihydrate INJECTION, SOLUTION INTRAVENOUS 19831026 ANDA ANDA087242 Hospira, Inc. AMINOPHYLLINE DIHYDRATE 25 mg/mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0409-6028_ff409c7c-00c5-462b-9da5-bc32db826537 0409-6028 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAVENOUS 19921030 NDA NDA019916 Hospira, Inc. MORPHINE SULFATE 5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-6030_b2b087fc-bcc3-4092-bfcd-dad65ca86c37 0409-6030 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19840816 ANDA ANDA088432 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-6043_086b9dd9-9ec7-4c4f-93f6-a0240c1163e3 0409-6043 HUMAN PRESCRIPTION DRUG Ammonium Chloride AMMONIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19840613 ANDA ANDA088366 Hospira, Inc. AMMONIUM CHLORIDE 5 meq/mL 0409-6102_3349611a-e8fd-436d-88e9-d16ee20fd57b 0409-6102 HUMAN PRESCRIPTION DRUG Furosemide FUROSEMIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19820528 NDA NDA018667 Hospira, Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0409-6138_a2d3edbf-b554-4230-a2d6-e55791799a84 0409-6138 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE IRRIGANT IRRIGATION 19740408 NDA NDA017514 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL 0409-6139_9e8c83eb-eb20-4342-860d-9a4686c00478 0409-6139 HUMAN PRESCRIPTION DRUG Sterile Water Water IRRIGANT IRRIGATION 19740408 NDA NDA017513 Hospira, Inc. WATER 1 mL/mL 0409-6140_7a6d4e9b-bdfb-4d3a-a2b0-7666dea0f682 0409-6140 HUMAN PRESCRIPTION DRUG Ringers SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE IRRIGANT IRRIGATION 20100621 NDA NDA017635 Hospira, Inc. CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 33; 30; 860 mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0409-6141_9a44d861-5d5c-460e-8457-c91a7a419adc 0409-6141 HUMAN PRESCRIPTION DRUG Physiosol SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE IRRIGANT IRRIGATION 20110211 NDA NDA017637 Hospira, Inc. MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM CHLORIDE; SODIUM GLUCONATE 30; 37; 222; 526; 502 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-6143_dd9a3c93-1bfb-4d8d-9668-5533098af0fa 0409-6143 HUMAN PRESCRIPTION DRUG Acetic Acid Acetic Acid IRRIGANT IRRIGATION 19800101 NDA NDA017656 Hospira, Inc. ACETIC ACID 250 mg/100mL 0409-6177_48cb3a7a-dcfc-46e1-8750-d369ac838f7d 0409-6177 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAVENOUS 19910411 UNAPPROVED DRUG OTHER Hospira, Inc. MORPHINE SULFATE 25 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-6179_48cb3a7a-dcfc-46e1-8750-d369ac838f7d 0409-6179 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAVENOUS 19910411 UNAPPROVED DRUG OTHER Hospira, Inc. MORPHINE SULFATE 25 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-6476_09ad5767-477c-468c-a529-a8b35fc76c17 0409-6476 HUMAN PRESCRIPTION DRUG Erythrocin Lactobionate ERYTHROMYCIN LACTOBIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19861031 ANDA ANDA062638 Hospira, Inc. ERYTHROMYCIN LACTOBIONATE 500 mg/100mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0409-6482_3730e618-1faa-4edd-8ff0-e94873be809b 0409-6482 HUMAN PRESCRIPTION DRUG Erythrocin Lactobionate ERYTHROMYCIN LACTOBIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19860924 NDA NDA050609 Hospira, Inc. ERYTHROMYCIN LACTOBIONATE 500 mg/10mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0409-6509_7f8fbb70-0b6e-4b80-a172-15c547407448 0409-6509 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19901221 ANDA ANDA063076 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0409-6509_b6a16d7f-2d0b-4089-b72a-cc05d4c810e7 0409-6509 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19901221 ANDA ANDA063076 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0409-6510_7f90d1da-53c4-496e-bedc-16ed1502d399 0409-6510 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090429 ANDA ANDA065455 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 100 mg/mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0409-6531_3567d1c5-a226-46cf-b05d-b96d88f654c5 0409-6531 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19880804 ANDA ANDA062912 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 750 mg/15mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0409-6531_3e3bfd13-9e81-49c2-bb60-adb5d7f76caa 0409-6531 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19921029 ANDA ANDA062933 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 750 mg/250mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0409-6533_3567d1c5-a226-46cf-b05d-b96d88f654c5 0409-6533 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19880804 ANDA ANDA062912 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0409-6533_a7956f63-2787-4c14-b817-0530622fceac 0409-6533 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19880804 ANDA ANDA062912 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0409-6534_3e3bfd13-9e81-49c2-bb60-adb5d7f76caa 0409-6534 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19921029 ANDA ANDA062931 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 500 mg/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0409-6534_c834a2fc-e237-4e9c-9ac8-ede6f0638020 0409-6534 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19921029 ANDA ANDA062931 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 500 mg/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0409-6535_3e3bfd13-9e81-49c2-bb60-adb5d7f76caa 0409-6535 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19921029 ANDA ANDA062933 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 1 g/250mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0409-6535_c834a2fc-e237-4e9c-9ac8-ede6f0638020 0409-6535 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19921029 ANDA ANDA062933 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 1 g/250mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0409-6609_34d7b582-1a3c-4908-b411-73517bf9c99d 0409-6609 HUMAN PRESCRIPTION DRUG Neut Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20050822 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM BICARBONATE .2 g/5mL 0409-6609_3b35b803-2487-4eab-af90-787df8bf445a 0409-6609 HUMAN PRESCRIPTION DRUG Neut Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20140503 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM BICARBONATE .2 g/5mL 0409-6625_0511096c-1897-458a-b643-e99664657916 0409-6625 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 19850418 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM BICARBONATE 84 mg/mL 0409-6625_e91511e1-8b96-4786-8e10-001d9be56333 0409-6625 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20140313 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM BICARBONATE 84 mg/mL 0409-6629_c6f59d03-c2f2-4eb0-a488-5404c70da238 0409-6629 HUMAN PRESCRIPTION DRUG Quelicin Succinylcholine Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19530501 NDA NDA008845 Hospira, Inc. SUCCINYLCHOLINE CHLORIDE 20 mg/mL Depolarizing Neuromuscular Blocker [EPC],Neuromuscular Depolarizing Blockade [PE] 0409-6629_f218ec83-c8d2-4602-b9a0-015bc2b049a5 0409-6629 HUMAN PRESCRIPTION DRUG Quelicin Succinylcholine Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19530501 NDA NDA008845 Hospira, Inc. SUCCINYLCHOLINE CHLORIDE 20 mg/mL Depolarizing Neuromuscular Blocker [EPC],Neuromuscular Depolarizing Blockade [PE] 0409-6635_769b86d4-7b81-47aa-9966-8035049001df 0409-6635 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19720316 ANDA ANDA080205 Hospira, Inc. POTASSIUM CHLORIDE 149 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-6636_769b86d4-7b81-47aa-9966-8035049001df 0409-6636 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19720316 ANDA ANDA080205 Hospira, Inc. POTASSIUM CHLORIDE 149 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-6637_0511096c-1897-458a-b643-e99664657916 0409-6637 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 19840413 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM BICARBONATE 84 mg/mL 0409-6648_45add090-a517-4f6a-bd89-86922a233e9e 0409-6648 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19800801 NDA NDA019445 Hospira, Inc. DEXTROSE MONOHYDRATE 25 g/50mL 0409-6651_769b86d4-7b81-47aa-9966-8035049001df 0409-6651 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19720316 ANDA ANDA080205 Hospira, Inc. POTASSIUM CHLORIDE 149 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-6653_769b86d4-7b81-47aa-9966-8035049001df 0409-6653 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19720316 ANDA ANDA080205 Hospira, Inc. POTASSIUM CHLORIDE 149 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-6657_743d33f5-1d30-4178-8c90-13973d110609 0409-6657 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19840720 NDA NDA018897 Hospira, Inc. SODIUM CHLORIDE 2.92 g/20mL 0409-6660_743d33f5-1d30-4178-8c90-13973d110609 0409-6660 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19840720 NDA NDA018897 Hospira, Inc. SODIUM CHLORIDE 5.84 g/40mL 0409-6664_26018b07-2c16-4f23-87ff-df2897613ff4 0409-6664 HUMAN PRESCRIPTION DRUG Sodium Lactate SODIUM LACTATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19840905 NDA NDA018947 Hospira, Inc. SODIUM LACTATE 5.6 g/10mL 0409-6695_d0953fe2-d968-4db0-9c91-09dc109d2b81 0409-6695 HUMAN PRESCRIPTION DRUG Amidate ETOMIDATE INJECTION, SOLUTION INTRAVENOUS 19820907 NDA NDA018227 Hospira, Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 0409-6727_7fbbb2f5-026f-4091-93a3-60e3513a2d46 0409-6727 HUMAN PRESCRIPTION DRUG Magnesium Sulfate in Dextrose MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAVENOUS 19950711 NDA NDA020488 Hospira, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 10 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-6728_7fbbb2f5-026f-4091-93a3-60e3513a2d46 0409-6728 HUMAN PRESCRIPTION DRUG Magnesium Sulfate in Dextrose MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAVENOUS 19950711 NDA NDA020488 Hospira, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 20 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-6729_e0d6a008-e340-4d8c-8aa0-1202a3577cbc 0409-6729 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAVENOUS 19940624 NDA NDA020309 Hospira, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 4 g/100mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-6730_e0d6a008-e340-4d8c-8aa0-1202a3577cbc 0409-6730 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAVENOUS 19940624 NDA NDA020309 Hospira, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 4 g/50mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-6778_76db2ce9-dc0f-4dbc-9893-e6bb1f4bdff3 0409-6778 HUMAN PRESCRIPTION DRUG Lorazepam LORAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19940527 ANDA ANDA074282 Hospira, Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-6779_76db2ce9-dc0f-4dbc-9893-e6bb1f4bdff3 0409-6779 HUMAN PRESCRIPTION DRUG Lorazepam LORAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19940527 ANDA ANDA074282 Hospira, Inc. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-6780_76db2ce9-dc0f-4dbc-9893-e6bb1f4bdff3 0409-6780 HUMAN PRESCRIPTION DRUG Lorazepam LORAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19940527 ANDA ANDA074282 Hospira, Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-6781_76db2ce9-dc0f-4dbc-9893-e6bb1f4bdff3 0409-6781 HUMAN PRESCRIPTION DRUG Lorazepam LORAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19940527 ANDA ANDA074282 Hospira, Inc. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0409-7074_04ef4884-2c4e-4dfa-95bf-b0bb9ca56dcd 0409-7074 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19921130 NDA NDA020161 Hospira, Inc. POTASSIUM CHLORIDE 10 meq/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7075_04ef4884-2c4e-4dfa-95bf-b0bb9ca56dcd 0409-7075 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19921130 NDA NDA020161 Hospira, Inc. POTASSIUM CHLORIDE 200 meq/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7076_04ef4884-2c4e-4dfa-95bf-b0bb9ca56dcd 0409-7076 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19921130 NDA NDA020161 Hospira, Inc. POTASSIUM CHLORIDE 30 meq/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7077_04ef4884-2c4e-4dfa-95bf-b0bb9ca56dcd 0409-7077 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19921130 NDA NDA020161 Hospira, Inc. POTASSIUM CHLORIDE 400 meq/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7100_e1dc7b7d-0215-49e8-b680-8c9dbd4f2aa2 0409-7100 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19850715 NDA NDA019466 Hospira, Inc. DEXTROSE MONOHYDRATE 50 mg/mL 0409-7101_fb4e1dcf-9815-46ee-ac06-247d19ce225c 0409-7101 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19850715 NDA NDA019465 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL 0409-7107_879aa9af-e87c-46e2-b036-f8c66133f41e 0409-7107 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880324 NDA NDA019691 Hospira, Inc. DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 50; 1.49; 9 g/1000mL; g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7109_879aa9af-e87c-46e2-b036-f8c66133f41e 0409-7109 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880324 NDA NDA019691 Hospira, Inc. DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 50; 2.98; 9 g/1000mL; g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7111_693e1e2d-8a3c-4983-8e21-80a490935d94 0409-7111 HUMAN PRESCRIPTION DRUG Potassium Chloride in Lactated Ringers and Dextrose POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19881017 NDA NDA019685 Hospira, Inc. CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE .2; 50; 1.79; 6; 3.1 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0409-7113_693e1e2d-8a3c-4983-8e21-80a490935d94 0409-7113 HUMAN PRESCRIPTION DRUG Potassium Chloride in Lactated Ringers and Dextrose POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19881017 NDA NDA019685 Hospira, Inc. CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE .2; 50; 3.28; 6; 3.1 g/mL; g/mL; g/mL; g/mL; g/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0409-7115_e6716553-ac03-4c3a-bced-afa80b8be925 0409-7115 HUMAN PRESCRIPTION DRUG Potassium Chloride in Sodium Chloride SODIUM CHLORIDE and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19881017 NDA NDA019686 Hospira, Inc. POTASSIUM CHLORIDE; SODIUM CHLORIDE 1.49; 9 g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7116_e6716553-ac03-4c3a-bced-afa80b8be925 0409-7116 HUMAN PRESCRIPTION DRUG Potassium Chloride in Sodium Chloride SODIUM CHLORIDE and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19881017 NDA NDA019686 Hospira, Inc. POTASSIUM CHLORIDE; SODIUM CHLORIDE 2.98; 9 g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7118_dc7d9f9d-c8d8-40fc-8985-323fe0172e4e 0409-7118 HUMAN PRESCRIPTION DRUG Sterile Water WATER INJECTION, SOLUTION INTRAVENOUS 19891226 NDA NDA019869 Hospira, Inc. WATER 2000 mL/1 0409-7120_d5b12266-0d96-4a85-a229-739dadf937c8 0409-7120 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19891226 NDA NDA019893 Hospira, Inc. DEXTROSE MONOHYDRATE 70 g/100mL 0409-7121_d35d54e3-7e26-4c98-8fee-f88ce2eac095 0409-7121 HUMAN PRESCRIPTION DRUG Aminosyn II ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 19911219 NDA NDA020015 Hospira, Inc. ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; N-ACETYLTYROSINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE 993; 1018; 700; 738; 500; 300; 660; 1000; 1050; 172; 270; 298; 722; 530; 400; 200; 500 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0409-7132_fb4e1dcf-9815-46ee-ac06-247d19ce225c 0409-7132 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19880608 NDA NDA019759 Hospira, Inc. SODIUM CHLORIDE 450 mg/100mL 0409-7138_a2d3edbf-b554-4230-a2d6-e55791799a84 0409-7138 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE IRRIGANT IRRIGATION 19740408 NDA NDA017514 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL 0409-7139_9e8c83eb-eb20-4342-860d-9a4686c00478 0409-7139 HUMAN PRESCRIPTION DRUG Sterile Water Water IRRIGANT IRRIGATION 19740408 NDA NDA017513 Hospira, Inc. WATER 1 mL/mL 0409-7171_9072c9b0-4ce9-45ce-8510-8df848da63bd 0409-7171 HUMAN PRESCRIPTION DRUG Aminosyn II ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 19911219 NDA NDA020041 Hospira, Inc. ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; N-ACETYLTYROSINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE 1490; 1527; 1050; 1107; 750; 450; 990; 1500; 1575; 258; 405; 447; 1083; 795; 600; 300; 750 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0409-7172_9072c9b0-4ce9-45ce-8510-8df848da63bd 0409-7172 HUMAN PRESCRIPTION DRUG Aminosyn II ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 19911219 NDA NDA020015 Hospira, Inc. ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; N-ACETYLTYROSINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; VALINE 993; 1018; 700; 738; 500; 300; 660; 1000; 1050; 172; 270; 298; 722; 530; 400; 200; 500 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 0409-7241_07afef12-9fb4-44bd-b46b-1bf2f6104cf8 0409-7241 HUMAN PRESCRIPTION DRUG Epinephrine EPINEPHRINE INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20130812 UNAPPROVED DRUG OTHER Hospira, Inc. EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-7241_8cc9697c-ee91-49c9-96d9-a06077f603b4 0409-7241 HUMAN PRESCRIPTION DRUG Epinephrine EPINEPHRINE INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20050908 UNAPPROVED DRUG OTHER Hospira, Inc. EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-7248_02347866-3cd4-4b9b-9349-b90f1c7cab98 0409-7248 HUMAN PRESCRIPTION DRUG Hetastarch in Sodium Chloride HETASTARCH INJECTION, SOLUTION INTRAVENOUS 19950130 ANDA BA740193 Hospira, Inc. HETASTARCH 6 g/100mL Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [Chemical/Ingredient] 0409-7263_01cca648-abb8-4d0c-80f9-d10befb9f8bd 0409-7263 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine Lidocaine Hydrochloride,Epinephrine Bitartrate INJECTION, SOLUTION DENTAL; INFILTRATION 20100210 ANDA ANDA078772 Hospira, Inc. EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .02; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-7295_69792419-00a6-4dce-9bd1-ef30e8466bc0 0409-7295 HUMAN PRESCRIPTION DRUG Potassium Phosphates POTASSIUM PHOSPHATE, MONOBASIC and POTASSIUM PHOSPHATE, DIBASIC INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19840917 UNAPPROVED DRUG OTHER Hospira, Inc. POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 236; 224 mg/mL; mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7295_b8049560-cb4b-414f-8311-30589575e414 0409-7295 HUMAN PRESCRIPTION DRUG Potassium Phosphates POTASSIUM PHOSPHATE, MONOBASIC and POTASSIUM PHOSPHATE, DIBASIC INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140701 UNAPPROVED DRUG OTHER Hospira, Inc. POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 236; 224 mg/mL; mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7299_2a2c74d1-81e8-4b38-91f5-0b5e96d761ad 0409-7299 HUMAN PRESCRIPTION DRUG Sodium Acetate SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140305 NDA NDA018893 Hospira, Inc. SODIUM ACETATE ANHYDROUS 3.28 g/20mL 0409-7299_41198ce0-5171-43e5-9e76-960dfdd61520 0409-7299 HUMAN PRESCRIPTION DRUG Sodium Acetate SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19830504 NDA NDA018893 Hospira, Inc. SODIUM ACETATE ANHYDROUS 3.28 g/20mL 0409-7332_fafb3502-e241-4879-bd82-decd34ddfb84 0409-7332 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Hospira, Inc CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-7333_142b9166-cc0e-4ced-bd26-d96367823159 0409-7333 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050503 ANDA ANDA065204 Hospira, Inc CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-7333_795399b0-1aef-4445-bf06-8532f179273b 0409-7333 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050503 ANDA ANDA065204 Hospira, Inc CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-7334_7a189a72-851f-461b-a6bd-91ba95918f82 0409-7334 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050517 ANDA ANDA065168 Hospira, Inc CEFTRIAXONE SODIUM 10 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-7335_fafb3502-e241-4879-bd82-decd34ddfb84 0409-7335 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Hospira, Inc CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-7336_142b9166-cc0e-4ced-bd26-d96367823159 0409-7336 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050503 ANDA ANDA065204 Hospira, Inc CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-7336_795399b0-1aef-4445-bf06-8532f179273b 0409-7336 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050503 ANDA ANDA065204 Hospira, Inc CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-7337_fafb3502-e241-4879-bd82-decd34ddfb84 0409-7337 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Hospira, Inc CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-7338_fafb3502-e241-4879-bd82-decd34ddfb84 0409-7338 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Hospira, Inc CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0409-7371_fe2d8a27-74b5-47d6-aa0c-23b7741a27e7 0409-7371 HUMAN PRESCRIPTION DRUG Ionosol and Dextrose DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, DIBASIC, and SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 20110325 NDA NDA019515 Hospira, Inc. DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 5; 53; 100; 100; 180; 280; 16 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7372_027c9dc1-52a8-430f-a15e-8559fe53be65 0409-7372 HUMAN PRESCRIPTION DRUG Ionosol and Dextrose DEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, and SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 20110325 NDA NDA019513 Hospira, Inc. DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 5; 30; 141; 15; 260; 25 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7385_ae346f72-d711-412a-a90c-3648e23beb7c 0409-7385 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline Dihydrate INJECTION, SOLUTION INTRAVENOUS 19831026 ANDA ANDA087242 Hospira, Inc. AMINOPHYLLINE DIHYDRATE 25 mg/mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0409-7386_ae346f72-d711-412a-a90c-3648e23beb7c 0409-7386 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline Dihydrate INJECTION, SOLUTION INTRAVENOUS 19831026 ANDA ANDA087242 Hospira, Inc. AMINOPHYLLINE DIHYDRATE 25 mg/mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0409-7391_43fbcc30-f893-4320-ba35-987410460359 0409-7391 HUMAN PRESCRIPTION DRUG Sodium Phosphates SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE and SODIUM PHOSPHATE, DIBASIC, ANHYDROUS INJECTION, SOLUTION INTRAVENOUS 19830510 NDA NDA018892 Hospira, Inc. SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 142; 276 mg/mL; mg/mL 0409-7418_bd25ca3a-9ae4-43e0-be3b-1931feda07d3 0409-7418 HUMAN PRESCRIPTION DRUG LMD in Dextrose DEXTRAN 40 INJECTION, SOLUTION INTRAVENOUS 19921030 ANDA BA720563 Hospira, Inc. DEXTRAN 40 10 g/100mL Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA] 0409-7419_bd25ca3a-9ae4-43e0-be3b-1931feda07d3 0409-7419 HUMAN PRESCRIPTION DRUG LMD in Sodium Chloride DEXTRAN 40 INJECTION, SOLUTION INTRAVENOUS 19921030 ANDA BA720562 Hospira, Inc. DEXTRAN 40 10 g/100mL Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA] 0409-7517_45add090-a517-4f6a-bd89-86922a233e9e 0409-7517 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19860603 NDA NDA019445 Hospira, Inc. DEXTROSE MONOHYDRATE 25 g/50mL 0409-7551_02a79b05-0dee-4505-8c4e-0e98b09119b6 0409-7551 HUMAN PRESCRIPTION DRUG Mepivacaine Hydrochloride Mepivacaine Hydrochloride INJECTION, SOLUTION DENTAL; INFILTRATION 20091109 ANDA ANDA040806 Hospira, Inc. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-7600_19364556-9400-47fa-9bc9-b42b481e34bf 0409-7600 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride and Epinephrine BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE INJECTION, SOLUTION DENTAL; INFILTRATION 19721003 NDA NDA022046 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 5; .0091 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-7620_bdcb13bb-83b4-45f7-9e69-963938f62d11 0409-7620 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19840131 NDA NDA018916 Hospira, Inc. HEPARIN SODIUM 200 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0409-7650_df1c477c-67ea-4f98-8a64-4622ef25b5b8 0409-7650 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19840131 NDA NDA018916 Hospira, Inc. HEPARIN SODIUM 10000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0409-7651_df1c477c-67ea-4f98-8a64-4622ef25b5b8 0409-7651 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19840131 NDA NDA018916 Hospira, Inc. HEPARIN SODIUM 5000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0409-7666_25ec59eb-003e-4c90-9567-c7b1656ad008 0409-7666 HUMAN PRESCRIPTION DRUG Theophylline in Dextrose THEOPHYLLINE INJECTION, SOLUTION INTRAVENOUS 19840102 NDA NDA019211 Hospira, Inc. THEOPHYLLINE 160 mg/100mL 0409-7668_25ec59eb-003e-4c90-9567-c7b1656ad008 0409-7668 HUMAN PRESCRIPTION DRUG Theophylline in Dextrose THEOPHYLLINE INJECTION, SOLUTION INTRAVENOUS 19840102 NDA NDA019211 Hospira, Inc. THEOPHYLLINE 200 mg/100mL 0409-7670_1ddca328-933a-4812-a4e0-70b69a11a7bd 0409-7670 HUMAN PRESCRIPTION DRUG Normosol-R SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20101004 NDA NDA017586 Hospira, Inc. MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM CHLORIDE; SODIUM GLUCONATE 30; 37; 222; 526; 502 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-7670_241de6c7-7b96-481f-afc5-820b36ff2f2d 0409-7670 HUMAN PRESCRIPTION DRUG Normosol-R SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20100920 NDA NDA017586 Hospira, Inc. MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM CHLORIDE; SODIUM GLUCONATE 30; 37; 222; 526; 502 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-7677_25ec59eb-003e-4c90-9567-c7b1656ad008 0409-7677 HUMAN PRESCRIPTION DRUG Theophylline in Dextrose THEOPHYLLINE INJECTION, SOLUTION INTRAVENOUS 19840102 NDA NDA019211 Hospira, Inc. THEOPHYLLINE 400 mg/100mL 0409-7705_25ec59eb-003e-4c90-9567-c7b1656ad008 0409-7705 HUMAN PRESCRIPTION DRUG Theophylline in Dextrose THEOPHYLLINE INJECTION, SOLUTION INTRAVENOUS 19840102 NDA NDA019211 Hospira, Inc. THEOPHYLLINE 320 mg/100mL 0409-7712_b2afb88a-4b52-4b3d-a1e9-ad4b4383e91a 0409-7712 HUMAN PRESCRIPTION DRUG Mannitol MANNITOL INJECTION, SOLUTION INTRAVENOUS 19870108 NDA NDA019603 Hospira, Inc. MANNITOL 5 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 0409-7713_b2afb88a-4b52-4b3d-a1e9-ad4b4383e91a 0409-7713 HUMAN PRESCRIPTION DRUG Mannitol MANNITOL INJECTION, SOLUTION INTRAVENOUS 19870108 NDA NDA019603 Hospira, Inc. MANNITOL 10 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 0409-7714_b2afb88a-4b52-4b3d-a1e9-ad4b4383e91a 0409-7714 HUMAN PRESCRIPTION DRUG Mannitol MANNITOL INJECTION, SOLUTION INTRAVENOUS 19870108 NDA NDA019603 Hospira, Inc. MANNITOL 15 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 0409-7715_b2afb88a-4b52-4b3d-a1e9-ad4b4383e91a 0409-7715 HUMAN PRESCRIPTION DRUG Mannitol MANNITOL INJECTION, SOLUTION INTRAVENOUS 19870108 NDA NDA019603 Hospira, Inc. MANNITOL 20 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 0409-7730_5cfe5cca-4976-44bd-b091-3365da10adef 0409-7730 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19790404 NDA NDA018090 Hospira, Inc. SODIUM CHLORIDE 450 mg/100mL 0409-7760_842eecf2-f4de-497f-b5f8-a28e0bd75e8f 0409-7760 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19890125 NDA NDA019805 Hospira, Inc. HEPARIN SODIUM 4000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0409-7761_842eecf2-f4de-497f-b5f8-a28e0bd75e8f 0409-7761 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19890125 NDA NDA019805 Hospira, Inc. HEPARIN SODIUM 5000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0409-7793_2996c258-75ce-4254-8197-b2d2326cf215 0409-7793 HUMAN PRESCRIPTION DRUG Heparin Sodium and Dextrose HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19850327 NDA NDA019339 Hospira, Inc. HEPARIN SODIUM 10000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0409-7794_2996c258-75ce-4254-8197-b2d2326cf215 0409-7794 HUMAN PRESCRIPTION DRUG Heparin Sodium and Dextrose HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19850327 NDA NDA019339 Hospira, Inc. HEPARIN SODIUM 5000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0409-7808_933fc53f-e78e-4e21-8b82-91bb88bce1bf 0409-7808 HUMAN PRESCRIPTION DRUG Dopamine Hydrochloride and Dextrose DOPAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19830930 NDA NDA018826 Hospira, Inc. DOPAMINE HYDROCHLORIDE .8 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-7809_933fc53f-e78e-4e21-8b82-91bb88bce1bf 0409-7809 HUMAN PRESCRIPTION DRUG Dopamine Hydrochloride and Dextrose DOPAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19830930 NDA NDA018826 Hospira, Inc. DOPAMINE HYDROCHLORIDE 1.6 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-7810_933fc53f-e78e-4e21-8b82-91bb88bce1bf 0409-7810 HUMAN PRESCRIPTION DRUG Dopamine Hydrochloride and Dextrose DOPAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19830930 NDA NDA018826 Hospira, Inc. DOPAMINE HYDROCHLORIDE 3.2 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-7811_e225ff16-7e7b-42e3-9a85-ecb028967476 0409-7811 HUMAN PRESCRIPTION DRUG Metronidazole METRONIDAZOLE INJECTION, SOLUTION INTRAVENOUS 19831118 NDA NDA018890 Hospira, Inc. METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0409-7828_ac48012c-264b-4ce6-8400-853ac1505a6d 0409-7828 HUMAN PRESCRIPTION DRUG Lactated Ringers SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE IRRIGANT IRRIGATION 19860117 NDA NDA019416 Hospira, Inc. CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20; 30; 600; 310 mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0409-7879_6cc0c93c-804d-4eba-a5f0-5fe237a573d3 0409-7879 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate in Sodium Chloride GENTAMICIN SULFATE INJECTION, SOLUTION INTRAVENOUS 20091204 ANDA ANDA062414 Hospira, Inc. GENTAMICIN SULFATE 1.2 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0409-7881_6cc0c93c-804d-4eba-a5f0-5fe237a573d3 0409-7881 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate in Sodium Chloride GENTAMICIN SULFATE INJECTION, SOLUTION INTRAVENOUS 20091204 ANDA ANDA062414 Hospira, Inc. GENTAMICIN SULFATE 1.4 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0409-7883_6cc0c93c-804d-4eba-a5f0-5fe237a573d3 0409-7883 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate in Sodium Chloride GENTAMICIN SULFATE INJECTION, SOLUTION INTRAVENOUS 20091204 ANDA ANDA062414 Hospira, Inc. GENTAMICIN SULFATE 1.6 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0409-7884_6cc0c93c-804d-4eba-a5f0-5fe237a573d3 0409-7884 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate in Sodium Chloride GENTAMICIN SULFATE INJECTION, SOLUTION INTRAVENOUS 20091204 ANDA ANDA062414 Hospira, Inc. GENTAMICIN SULFATE .8 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0409-7886_6cc0c93c-804d-4eba-a5f0-5fe237a573d3 0409-7886 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate in Sodium Chloride GENTAMICIN SULFATE INJECTION, SOLUTION INTRAVENOUS 20091204 ANDA ANDA062414 Hospira, Inc. GENTAMICIN SULFATE .9 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0409-7889_6cc0c93c-804d-4eba-a5f0-5fe237a573d3 0409-7889 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate in Sodium Chloride GENTAMICIN SULFATE INJECTION, SOLUTION INTRAVENOUS 20091204 ANDA ANDA062414 Hospira, Inc. GENTAMICIN SULFATE 1 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0409-7901_879aa9af-e87c-46e2-b036-f8c66133f41e 0409-7901 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19800529 NDA NDA018365 Hospira, Inc. DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 50; 1.49; 2.25 g/1000mL; g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7902_879aa9af-e87c-46e2-b036-f8c66133f41e 0409-7902 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19800529 NDA NDA018362 Hospira, Inc. DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 50; 1.49; 4.5 g/1000mL; g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7903_879aa9af-e87c-46e2-b036-f8c66133f41e 0409-7903 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19800529 NDA NDA018362 Hospira, Inc. DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 50; 2.24; 4.5 g/1000mL; g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7904_879aa9af-e87c-46e2-b036-f8c66133f41e 0409-7904 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19800529 NDA NDA018362 Hospira, Inc. DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 50; 2.98; 4.5 g/1000mL; g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7905_43152199-496d-4be2-bf34-5b82b6240dc6 0409-7905 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose DEXTROSE MONOHYDRATE and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19800529 NDA NDA018371 Hospira, Inc. DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE 5; .149 g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7906_43152199-496d-4be2-bf34-5b82b6240dc6 0409-7906 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose DEXTROSE MONOHYDRATE and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19800529 NDA NDA018371 Hospira, Inc. DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE 5; .298 g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7918_e3efa8bf-6025-4302-8093-292aec16fe69 0409-7918 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19820323 NDA NDA018561 Hospira, Inc. DEXTROSE MONOHYDRATE 70 g/100mL 0409-7922_085ece8a-a1e7-4aa6-b823-8e75d079d8af 0409-7922 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19710212 NDA NDA016367 Hospira, Inc. DEXTROSE MONOHYDRATE 5 g/100mL 0409-7922_fd00d8ec-9905-4464-bf79-07772efe09ec 0409-7922 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19710212 NDA NDA016367 Hospira, Inc. DEXTROSE MONOHYDRATE 5 g/100mL 0409-7923_085ece8a-a1e7-4aa6-b823-8e75d079d8af 0409-7923 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19710212 NDA NDA016367 Hospira, Inc. DEXTROSE MONOHYDRATE 5 g/100mL 0409-7923_fd00d8ec-9905-4464-bf79-07772efe09ec 0409-7923 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19710212 NDA NDA016367 Hospira, Inc. DEXTROSE MONOHYDRATE 5 g/100mL 0409-7924_75b1ae31-6e3e-44eb-8c03-6cd7bc45f2d7 0409-7924 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19750813 NDA NDA017606 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; .225 g/100mL; g/100mL 0409-7925_75b1ae31-6e3e-44eb-8c03-6cd7bc45f2d7 0409-7925 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19770412 NDA NDA017799 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; .3 g/100mL; g/100mL 0409-7926_75b1ae31-6e3e-44eb-8c03-6cd7bc45f2d7 0409-7926 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19750813 NDA NDA017607 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; .45 g/100mL; g/100mL 0409-7929_25210a1d-cbca-4a68-aa92-a309c35032dd 0409-7929 HUMAN PRESCRIPTION DRUG Lactated Ringers and Dextrose SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19750813 NDA NDA017608 Hospira, Inc. CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20; 5; 30; 600; 310 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0409-7930_fd00d8ec-9905-4464-bf79-07772efe09ec 0409-7930 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19790828 NDA NDA018080 Hospira, Inc. DEXTROSE MONOHYDRATE 10 g/100mL 0409-7931_d215a037-64f4-4b7d-b7b7-13befadd619f 0409-7931 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Dextrose LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19801219 NDA NDA018388 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 400 mg/100mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-7935_e3efa8bf-6025-4302-8093-292aec16fe69 0409-7935 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19820323 NDA NDA018564 Hospira, Inc. DEXTROSE MONOHYDRATE 20 g/100mL 0409-7936_e3efa8bf-6025-4302-8093-292aec16fe69 0409-7936 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19820323 NDA NDA018563 Hospira, Inc. DEXTROSE MONOHYDRATE 50 g/100mL 0409-7937_e3efa8bf-6025-4302-8093-292aec16fe69 0409-7937 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19820323 NDA NDA018562 Hospira, Inc. DEXTROSE MONOHYDRATE 40 g/100mL 0409-7938_1291fcb4-20ab-4486-a318-2d5d07751120 0409-7938 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19790828 NDA NDA018080 Hospira, Inc. DEXTROSE MONOHYDRATE 10 g/100mL 0409-7939_d215a037-64f4-4b7d-b7b7-13befadd619f 0409-7939 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Dextrose LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19801219 NDA NDA018388 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 800 mg/100mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-7941_75b1ae31-6e3e-44eb-8c03-6cd7bc45f2d7 0409-7941 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19760107 NDA NDA017585 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; .9 g/100mL; g/100mL 0409-7953_25210a1d-cbca-4a68-aa92-a309c35032dd 0409-7953 HUMAN PRESCRIPTION DRUG Lactated Ringers SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19760126 NDA NDA017641 Hospira, Inc. CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20; 30; 600; 310 mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0409-7965_9e1653a3-715a-401f-9143-5b371be87d08 0409-7965 HUMAN PRESCRIPTION DRUG Normosol-M and Dextrose DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, and MAGNESIUM ACETATE INJECTION, SOLUTION INTRAVENOUS 19750813 NDA NDA017610 Hospira, Inc. DEXTROSE MONOHYDRATE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE 5; 21; 128; 234 g/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-7965_b028e290-8116-4fee-a7f1-f43cd0dc1eab 0409-7965 HUMAN PRESCRIPTION DRUG Normosol-M and Dextrose DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, and MAGNESIUM ACETATE INJECTION, SOLUTION INTRAVENOUS 19750813 NDA NDA017610 Hospira, Inc. DEXTROSE MONOHYDRATE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE 5; 21; 128; 234 g/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-7967_21b6f3b6-8ebe-4b6e-a58f-707cf77cf704 0409-7967 HUMAN PRESCRIPTION DRUG Normosol-R SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20100920 NDA NDA017586 Hospira, Inc. MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM CHLORIDE; SODIUM GLUCONATE 30; 37; 222; 526; 502 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-7967_22e5f211-a66a-4680-8985-184f199f299b 0409-7967 HUMAN PRESCRIPTION DRUG Normosol-R SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110322 NDA NDA017586 Hospira, Inc. MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM CHLORIDE; SODIUM GLUCONATE 30; 37; 222; 526; 502 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-7968_c4dc9f87-79d3-4a95-b16e-27e02342a5a2 0409-7968 HUMAN PRESCRIPTION DRUG Normosol-R and Dextrose Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride INJECTION, SOLUTION INTRAVENOUS 20100916 NDA NDA017609 Hospira, Inc. DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM CHLORIDE; SODIUM GLUCONATE 5; 30; 37; 222; 526; 502 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-7969_5b6d2adc-0bfd-4045-a302-d92dd4f17496 0409-7969 HUMAN PRESCRIPTION DRUG Plegisol POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, and MAGNESIUM CHLORIDE INJECTION, SOLUTION INTRA-ARTERIAL 20090909 NDA NDA018608 Hospira, Inc. CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 17.6; 325.3; 119.3; 643 mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0409-7972_a2d3edbf-b554-4230-a2d6-e55791799a84 0409-7972 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE IRRIGANT IRRIGATION 19800222 NDA NDA018314 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL 0409-7972_e683a0ec-ae48-4190-ad50-3ae7914152df 0409-7972 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE IRRIGANT IRRIGATION 19800222 NDA NDA018314 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL 0409-7973_9e8c83eb-eb20-4342-860d-9a4686c00478 0409-7973 HUMAN PRESCRIPTION DRUG Sterile Water Water IRRIGANT IRRIGATION 19800222 NDA NDA018313 Hospira, Inc. WATER 1 mL/mL 0409-7974_d3384686-ccda-4139-91c4-6d4913ae4f8a 0409-7974 HUMAN PRESCRIPTION DRUG Glycine GLYCINE IRRIGANT IRRIGATION 19800222 NDA NDA018315 Hospira, Inc. GLYCINE 1.5 g/100mL 0409-7981_460413b8-6f58-4f6b-9f82-9caf592d6bf3 0409-7981 HUMAN PRESCRIPTION DRUG Sorbitol-Mannitol SORBITOL and MANNITOL IRRIGANT URETHRAL 19800222 NDA NDA018316 Hospira, Inc. MANNITOL; SORBITOL .54; 2.7 g/100mL; g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 0409-7982_47d5a456-3f64-4ca5-9cfc-bc935ae77c99 0409-7982 HUMAN PRESCRIPTION DRUG RINGERS SODIUM CHLORIDE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19800516 NDA NDA018251 Hospira, Inc. CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 33; 30; 860 mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0409-7982_c1916a1b-6b4b-450c-8ce6-ab05556cb979 0409-7982 HUMAN PRESCRIPTION DRUG Ringers SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19800516 NDA NDA018251 Hospira, Inc. CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 33; 30; 860 mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0409-7983_5cfe5cca-4976-44bd-b091-3365da10adef 0409-7983 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19720224 NDA NDA016366 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL 0409-7983_ca013908-6d2b-4938-8ddb-f0eb8776ce30 0409-7983 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19720224 NDA NDA016366 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL 0409-7984_5cfe5cca-4976-44bd-b091-3365da10adef 0409-7984 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19720224 NDA NDA016366 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL 0409-7984_7069f07d-7c49-4738-9d89-8bf69505504a 0409-7984 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19720224 NDA NDA016366 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL 0409-7985_5cfe5cca-4976-44bd-b091-3365da10adef 0409-7985 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19790404 NDA NDA018090 Hospira, Inc. SODIUM CHLORIDE 450 mg/100mL 0409-7985_f950fafd-7856-4356-ae1b-b2d1a8926a7e 0409-7985 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19790404 NDA NDA018090 Hospira, Inc. SODIUM CHLORIDE 450 mg/100mL 0409-7990_26e0a8e0-6767-46f0-9f5c-f52629933743 0409-7990 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION, SOLUTION INTRAVENOUS 20120404 NDA NDA018233 Hospira, Inc. WATER 1000 mL/1000mL 0409-7990_7e03f338-13de-4b74-ab6e-7b73c8ed7ef5 0409-7990 HUMAN PRESCRIPTION DRUG Sterile Water WATER INJECTION, SOLUTION INTRAVENOUS 20110401 NDA NDA018233 Hospira, Inc. WATER 1000 mL/1000mL 0409-7991_879aa9af-e87c-46e2-b036-f8c66133f41e 0409-7991 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19800529 NDA NDA018365 Hospira, Inc. DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 50; 2.24; 2.25 g/1000mL; g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7992_879aa9af-e87c-46e2-b036-f8c66133f41e 0409-7992 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19800529 NDA NDA018365 Hospira, Inc. DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 50; 2.98; 2.25 g/1000mL; g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7993_879aa9af-e87c-46e2-b036-f8c66133f41e 0409-7993 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19800529 NDA NDA018362 Hospira, Inc. DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 50; .745; 4.5 g/1000mL; g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7996_43152199-496d-4be2-bf34-5b82b6240dc6 0409-7996 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose DEXTROSE MONOHYDRATE and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19800529 NDA NDA018371 Hospira, Inc. DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE 5; .224 g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-7998_879aa9af-e87c-46e2-b036-f8c66133f41e 0409-7998 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19860117 NDA NDA018876 Hospira, Inc. DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 50; 1.49; 3 g/1000mL; g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-8004_e3efa8bf-6025-4302-8093-292aec16fe69 0409-8004 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19850126 NDA NDA019345 Hospira, Inc. DEXTROSE MONOHYDRATE 30 g/100mL 0409-8060_d0953fe2-d968-4db0-9c91-09dc109d2b81 0409-8060 HUMAN PRESCRIPTION DRUG Amidate Etomidate INJECTION, SOLUTION INTRAVENOUS 19820907 NDA NDA018227 Hospira, Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 0409-8061_d0953fe2-d968-4db0-9c91-09dc109d2b81 0409-8061 HUMAN PRESCRIPTION DRUG Amidate Etomidate INJECTION, SOLUTION INTRAVENOUS 19820907 NDA NDA018227 Hospira, Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 0409-8062_d0953fe2-d968-4db0-9c91-09dc109d2b81 0409-8062 HUMAN PRESCRIPTION DRUG Amidate Etomidate INJECTION, SOLUTION INTRAVENOUS 19820907 NDA NDA018227 Hospira, Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 0409-8183_0cafd7a9-5378-4534-b6bd-75beb1586cb6 0409-8183 HUMAN PRESCRIPTION DRUG Potassium Acetate POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140327 NDA NDA018896 Hospira, Inc. POTASSIUM ACETATE 3.93 g/20mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-8183_5d3b4496-5051-4207-be1c-1e7da767d38e 0409-8183 HUMAN PRESCRIPTION DRUG Potassium Acetate POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19840720 NDA NDA018896 Hospira, Inc. POTASSIUM ACETATE 3.93 g/20mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-9042_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-9042 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride and Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 19880616 ANDA ANDA071165 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-9043_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-9043 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride and Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION 19880616 ANDA ANDA071167 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-9045_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-9045 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride and Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INTRACAUDAL 19880616 ANDA ANDA071168 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-9046_5a59d5e5-009d-494d-b4bf-43a881b4b0fe 0409-9046 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride and Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION 19880616 ANDA ANDA071170 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-9093_a0782d2b-b0dd-457c-a502-0af95f753e35 0409-9093 HUMAN PRESCRIPTION DRUG Fentanyl Citrate FENTANYL CITRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19850112 NDA NDA019115 Hospira, Inc. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-9094_a0782d2b-b0dd-457c-a502-0af95f753e35 0409-9094 HUMAN PRESCRIPTION DRUG Fentanyl Citrate FENTANYL CITRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19850112 NDA NDA019115 Hospira, Inc. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0409-9104_feea1a53-bf24-4c1a-bdaa-5bf7b3f69b11 0409-9104 HUMAN PRESCRIPTION DRUG DOPamine Hydrochloride Dopamine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19810519 NDA NDA018132 Hospira, Inc. DOPAMINE HYDROCHLORIDE 40 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-9137_5912fa62-8d33-4c9f-bc4e-dc83f55a406f 0409-9137 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19980928 ANDA ANDA040302 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0409-9157_1f7c14aa-9037-42b4-b614-bfbe43830b61 0409-9157 HUMAN PRESCRIPTION DRUG Vitamin K1 PHYTONADIONE INJECTION, EMULSION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19830725 ANDA ANDA087954 Hospira, Inc. PHYTONADIONE 2 mg/mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 0409-9158_1f7c14aa-9037-42b4-b614-bfbe43830b61 0409-9158 HUMAN PRESCRIPTION DRUG Vitamin K1 PHYTONADIONE INJECTION, EMULSION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19830725 ANDA ANDA087955 Hospira, Inc. PHYTONADIONE 10 mg/mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 0409-9257_bd2452be-a773-4bf3-8928-c847d6695679 0409-9257 HUMAN PRESCRIPTION DRUG Potassium Chloride in Sodium Chloride SODIUM CHLORIDE and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20080910 ANDA ANDA078446 Hospira, Inc. POTASSIUM CHLORIDE; SODIUM CHLORIDE 1.49; 4.5 g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0409-9300_6276a39b-66ef-487d-b24b-d5f001755647 0409-9300 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20140923 ANDA ANDA090194 Hospira, Inc. ROPIVACAINE HYDROCHLORIDE 2 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-9301_6276a39b-66ef-487d-b24b-d5f001755647 0409-9301 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20140923 ANDA ANDA090194 Hospira, Inc. ROPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-9302_6276a39b-66ef-487d-b24b-d5f001755647 0409-9302 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20140923 ANDA ANDA090194 Hospira, Inc. ROPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-9303_6276a39b-66ef-487d-b24b-d5f001755647 0409-9303 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL 20140923 ANDA ANDA090194 Hospira, Inc. ROPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0409-9366_fefdb135-3042-446f-8435-f52fa21d8358 0409-9366 HUMAN PRESCRIPTION DRUG Articaine Hydrochloride and Epinephrine ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION DENTAL; INFILTRATION 20110401 ANDA ANDA079138 Hospira, Inc. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .018 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0409-9558_0fd4aec6-a17e-4218-9074-336bebb47f58 0409-9558 HUMAN PRESCRIPTION DRUG ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTION, SOLUTION INTRAVENOUS 20081215 ANDA ANDA078519 Hospira, Inc. ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0409-9558_af518712-b7ba-4912-b83e-5c16aafb148c 0409-9558 HUMAN PRESCRIPTION DRUG Rocuronium Bromide Rocuronium Bromide INJECTION, SOLUTION INTRAVENOUS 20081126 ANDA ANDA078519 Hospira, Inc. ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0409-9629_12a8b31c-fd3e-4f2c-999b-9cc83cc6932f 0409-9629 HUMAN PRESCRIPTION DRUG Atropine Sulfate ATROPINE SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110629 NDA NDA021146 Hospira, Inc. ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0409-9630_12a8b31c-fd3e-4f2c-999b-9cc83cc6932f 0409-9630 HUMAN PRESCRIPTION DRUG Atropine Sulfate ATROPINE SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110629 NDA NDA021146 Hospira, Inc. ATROPINE SULFATE .05 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0409-9631_3349611a-e8fd-436d-88e9-d16ee20fd57b 0409-9631 HUMAN PRESCRIPTION DRUG Furosemide FUROSEMIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19990528 ANDA ANDA075241 Hospira, Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0409-9633_e6213a51-c663-4cd4-bdf7-560e4f047d58 0409-9633 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19981020 ANDA ANDA075136 Hospira, Inc. VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0409-9786_5794fe25-4f2c-4b31-a57b-8b98c3e05a46 0409-9786 HUMAN PRESCRIPTION DRUG Liposyn II SAFFLOWER OIL, SOYBEAN OIL, and EGG PHOSPHOLIPIDS INJECTION, EMULSION INTRAVENOUS 19840827 NDA NDA018997 Hospira, Inc. EGG PHOSPHOLIPIDS; SAFFLOWER OIL; SOYBEAN OIL 1.2; 5; 5 g/100mL; g/100mL; g/100mL 0409-9789_5794fe25-4f2c-4b31-a57b-8b98c3e05a46 0409-9789 HUMAN PRESCRIPTION DRUG Liposyn II SAFFLOWER OIL, SOYBEAN OIL, and EGG PHOSPHOLIPIDS INJECTION, EMULSION INTRAVENOUS 19840827 NDA NDA018991 Hospira, Inc. EGG PHOSPHOLIPIDS; SAFFLOWER OIL; SOYBEAN OIL 1.2; 10; 5 g/100mL; g/100mL; g/100mL 0409-9790_4839a05c-e162-4ac9-a008-6535d55f7945 0409-9790 HUMAN PRESCRIPTION DRUG Liposyn III SOYBEAN OIL, EGG PHOSPHOLIPIDS, and GLYCERIN INJECTION, EMULSION INTRAVENOUS 20110211 NDA NDA018969 Hospira, Inc. EGG PHOSPHOLIPIDS; GLYCERIN; SOYBEAN OIL 1.2; 2.5; 10 g/100mL; g/100mL; g/100mL Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient] 0409-9791_4839a05c-e162-4ac9-a008-6535d55f7945 0409-9791 HUMAN PRESCRIPTION DRUG Liposyn III SOYBEAN OIL, EGG PHOSPHOLIPIDS, and GLYCERIN INJECTION, EMULSION INTRAVENOUS 20110211 NDA NDA018970 Hospira, Inc. EGG PHOSPHOLIPIDS; GLYCERIN; SOYBEAN OIL 1.2; 2.5; 20 g/100mL; g/100mL; g/100mL Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient] 0430-0010_494a672d-5ba4-4db7-a55e-305ce8acc571 0430-0010 HUMAN PRESCRIPTION DRUG FEMCON Fe norethindrone and ethinyl estradiol, and ferrous fumarate KIT 20061101 NDA NDA021490 Warner Chilcott (US), LLC 0430-0114_37cd2dae-06b5-4e87-9872-8b5d9c7faabf 0430-0114 HUMAN PRESCRIPTION DRUG DORYX doxycycline hyclate TABLET, DELAYED RELEASE ORAL 20130701 NDA NDA050795 Warner Chilcott (US), LLC DOXYCYCLINE HYCLATE 200 mg/1 0430-0115_37cd2dae-06b5-4e87-9872-8b5d9c7faabf 0430-0115 HUMAN PRESCRIPTION DRUG DORYX doxycycline hyclate TABLET, DELAYED RELEASE ORAL 20110921 NDA NDA050795 Warner Chilcott (US), LLC DOXYCYCLINE HYCLATE 150 mg/1 0430-0145_b8211122-2e69-4873-9133-81e30727198a 0430-0145 HUMAN PRESCRIPTION DRUG femhrt norethindrone acetate/ethinyl estradiol TABLET ORAL 20091001 NDA NDA021065 Warner Chilcott (US), LLC ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 2.5; .5 ug/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0430-0170_fac466ed-35fc-4279-bb47-ba5b4cbda2fb 0430-0170 HUMAN PRESCRIPTION DRUG Enablex darifenacin TABLET, EXTENDED RELEASE ORAL 20041222 NDA NDA021513 Warner Chilcott (US), LLC DARIFENACIN HYDROBROMIDE 7.5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0430-0171_fac466ed-35fc-4279-bb47-ba5b4cbda2fb 0430-0171 HUMAN PRESCRIPTION DRUG Enablex darifenacin TABLET, EXTENDED RELEASE ORAL 20041222 NDA NDA021513 Warner Chilcott (US), LLC DARIFENACIN HYDROBROMIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0430-0210_b4b6a007-96cc-4cda-8305-7cd3a712e359 0430-0210 HUMAN PRESCRIPTION DRUG SARAFEM fluoxetine hydrochloride TABLET ORAL 20080624 NDA NDA021860 Warner Chilcott (US), LLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0430-0220_b4b6a007-96cc-4cda-8305-7cd3a712e359 0430-0220 HUMAN PRESCRIPTION DRUG SARAFEM fluoxetine hydrochloride TABLET ORAL 20080624 NDA NDA021860 Warner Chilcott (US), LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0430-0420_941ef26f-c78d-4314-abba-2d1c47afffd6 0430-0420 HUMAN PRESCRIPTION DRUG Lo Loestrin Fe norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate KIT 20101201 NDA NDA022501 Warner Chilcott (US), LLC 0430-0470_553e69cf-1e84-4400-9da0-baab64dd8798 0430-0470 HUMAN PRESCRIPTION DRUG Actonel RISEDRONATE SODIUM TABLET, FILM COATED ORAL 19980327 NDA NDA020835 Warner Chilcott (US), LLC RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 25.8; 4.2 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0430-0471_553e69cf-1e84-4400-9da0-baab64dd8798 0430-0471 HUMAN PRESCRIPTION DRUG Actonel RISEDRONATE SODIUM TABLET, FILM COATED ORAL 20000414 NDA NDA020835 Warner Chilcott (US), LLC RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 4.3; .7 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0430-0472_553e69cf-1e84-4400-9da0-baab64dd8798 0430-0472 HUMAN PRESCRIPTION DRUG Actonel RISEDRONATE SODIUM TABLET, FILM COATED ORAL 20020517 NDA NDA020835 Warner Chilcott (US), LLC RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 30.1; 4.9 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0430-0478_553e69cf-1e84-4400-9da0-baab64dd8798 0430-0478 HUMAN PRESCRIPTION DRUG Actonel RISEDRONATE SODIUM TABLET, FILM COATED ORAL 20080422 NDA NDA020835 Warner Chilcott (US), LLC RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 129; 21 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0430-0482_d4f52dd5-e715-408d-800f-4e558a7263f5 0430-0482 HUMAN PRESCRIPTION DRUG FEMCON Fe norethindrone and ethinyl estradiol, and ferrous fumarate KIT 20061101 NDA NDA021490 Warner Chilcott (US), LLC 0430-0530_136053e4-d7e9-40aa-996d-3e799ce13978 0430-0530 HUMAN PRESCRIPTION DRUG Loestrin 24 Fe norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20060301 NDA NDA021871 Warner Chilcott (US), LLC 0430-0535_0820f903-6d48-48c0-a257-db20dc3af83f 0430-0535 HUMAN PRESCRIPTION DRUG Minastrin 24 Fe norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20130614 NDA NDA203667 Warner Chilcott (US), LLC 0430-0537_cfa6d0b2-7e37-45dd-9d30-3ded4119cd0a 0430-0537 HUMAN PRESCRIPTION DRUG Lo Minastrin Fe norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate KIT 20130812 NDA NDA204654 Warner Chilcott (US), LLC 0430-0540_ebd17186-5a6d-4c42-8d3a-40d33de2eae7 0430-0540 HUMAN PRESCRIPTION DRUG Minastrin 24 Fe norethindrone acetate and ethinyl estradiol chewable tablets and ferrous fumarate tablets KIT 20130614 NDA NDA203667 Warner Chilcott (US), LLC 0430-0570_0275b156-948c-418e-8c46-d5f5e69557aa 0430-0570 HUMAN PRESCRIPTION DRUG ESTROSTEP Fe Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20050419 NDA NDA020130 Warner Chilcott (US), LLC 0430-0580_b6ab6a6e-3065-4841-aa86-4ba5cc27dde3 0430-0580 HUMAN PRESCRIPTION DRUG OVCON 35 Norethindrone and Ethinyl Estradiol KIT 20050601 ANDA ANDA076238 Warner Chilcott (US), LLC 0430-0720_049c9f13-fc5b-417b-b686-403f17052eae 0430-0720 HUMAN PRESCRIPTION DRUG ESTRACE estradiol TABLET ORAL 20111226 ANDA ANDA040197 Warner Chilcott (US), LLC ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0430-0721_049c9f13-fc5b-417b-b686-403f17052eae 0430-0721 HUMAN PRESCRIPTION DRUG ESTRACE estradiol TABLET ORAL 20111226 ANDA ANDA040197 Warner Chilcott (US), LLC ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0430-0722_049c9f13-fc5b-417b-b686-403f17052eae 0430-0722 HUMAN PRESCRIPTION DRUG ESTRACE estradiol TABLET ORAL 20111226 ANDA ANDA040197 Warner Chilcott (US), LLC ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0430-0752_ec9614e6-d944-4164-8ec0-ee3debe2425b 0430-0752 HUMAN PRESCRIPTION DRUG ASACOL mesalamine TABLET, DELAYED RELEASE ORAL 19920401 NDA NDA019651 Warner Chilcott (US), LLC MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 0430-0753_8a641c98-c627-4215-91ff-c5578f513dbb 0430-0753 HUMAN PRESCRIPTION DRUG Delzicol mesalamine CAPSULE, DELAYED RELEASE ORAL 20130301 NDA NDA204412 Warner Chilcott (US), LLC MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 0430-0783_500f2c67-fde9-4e1f-ac35-f6b3e59c42da 0430-0783 HUMAN PRESCRIPTION DRUG ASACOL HD mesalamine TABLET, DELAYED RELEASE ORAL 20080528 NDA NDA021830 Warner Chilcott (US), LLC MESALAMINE 800 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 0430-0979_c0bca6f4-5732-44b0-a33c-6da84746b83f 0430-0979 HUMAN PRESCRIPTION DRUG Atelvia risedronate sodium TABLET, DELAYED RELEASE ORAL 20101201 NDA NDA022560 Warner Chilcott (US), LLC RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 30.1; 4.9 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0430-3020_d7e426bc-f588-44c5-9325-a61c40634f8a 0430-3020 HUMAN PRESCRIPTION DRUG Dovonex Calcipotriene CREAM TOPICAL 20060101 NDA NDA020554 Warner Chilcott (US), LLC CALCIPOTRIENE 50 ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 0430-3030_7616651c-2085-45ab-88c6-f2cf8980e873 0430-3030 HUMAN PRESCRIPTION DRUG Dovonex Calcipotriene SOLUTION TOPICAL 20060101 NDA NDA020611 Warner Chilcott (US), LLC CALCIPOTRIENE .05 mg/mL Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 0430-3230_3da6d640-26a4-40cf-9f5d-9eaac588d6ff 0430-3230 HUMAN PRESCRIPTION DRUG TACLONEX calcipotriene and betamethasone dipropionate OINTMENT TOPICAL 20080601 NDA NDA021852 Warner Chilcott (US), LLC BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE .643; 50 mg/g; ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 0430-3240_66ee4852-e2c9-462f-9659-c365546b3cbd 0430-3240 HUMAN PRESCRIPTION DRUG TACLONEX SCALP calcipotriene 0.005% and betamethasone dipropionate 0.064% SPRAY, METERED TOPICAL 20080601 NDA NDA022185 Warner Chilcott (US), LLC BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE .643; 50 mg/g; ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 0430-3754_cd3b5d4b-6a3c-4b13-a0b1-5ac63e0d8cb4 0430-3754 HUMAN PRESCRIPTION DRUG ESTRACE estradiol CREAM VAGINAL 20010701 ANDA ANDA086069 Warner Chilcott (US), LLC ESTRADIOL .1 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0430-6201_4c5203e4-6c37-4dbc-a4a1-caa118b72c95 0430-6201 HUMAN PRESCRIPTION DRUG Femring estradiol acetate RING VAGINAL 20030701 NDA NDA021367 Warner Chilcott (US), LLC ESTRADIOL ACETATE .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0430-6202_4c5203e4-6c37-4dbc-a4a1-caa118b72c95 0430-6202 HUMAN PRESCRIPTION DRUG Femring estradiol acetate RING VAGINAL 20030701 NDA NDA021367 Warner Chilcott (US), LLC ESTRADIOL ACETATE .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0436-0669_616a2a4a-195e-48af-a1d9-191826b1d6ca 0436-0669 HUMAN OTC DRUG Di-Dak-Sol Sodium Hypochlorite SOLUTION TOPICAL 20010205 UNAPPROVED DRUG OTHER Century Pharmaceuticals, Inc. SODIUM HYPOCHLORITE .125 mg/mL 0436-0672_539dacdb-5ff0-4f52-a89b-4e2e46686339 0436-0672 HUMAN OTC DRUG Dakins Quarter Sodium Hypochlorite SOLUTION TOPICAL 20060524 UNAPPROVED DRUG OTHER Century Pharmaceuticals, Inc. SODIUM HYPOCHLORITE 1.25 mg/mL 0436-0936_3324001d-8341-47b0-8e0a-3109c72ecb78 0436-0936 HUMAN OTC DRUG Dakins Half Sodium Hypochlorite SOLUTION TOPICAL 19860609 UNAPPROVED DRUG OTHER Century Pharmaceuticals, Inc. SODIUM HYPOCHLORITE 2.5 mg/mL 0436-0946_606e5293-a2f3-48e3-8de4-269f86a72447 0436-0946 HUMAN OTC DRUG Dakins Full Sodium Hypochlorite SOLUTION TOPICAL 19831208 UNAPPROVED DRUG OTHER Century Pharmaceuticals, Inc. SODIUM HYPOCHLORITE 5 mg/mL 0440-1130_c2183561-837b-447a-8f41-8d9ac3457188 0440-1130 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, COATED ORAL 20120418 OTC MONOGRAPH NOT FINAL part343 Liberty Pharmaceuticals, Inc. ASPIRIN 325 ng/1 0440-1185_b93d2bc9-4b61-4b20-a036-0fca0e866e25 0440-1185 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Liberty Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 0440-1243_0ee1d6e4-614a-44d4-9778-03c54a635092 0440-1243 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060201 ANDA ANDA065215 Liberty Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0440-1282_e5d17d5a-fa9a-4175-bee8-97060d5338f1 0440-1282 HUMAN PRESCRIPTION DRUG CIMETIDINE CIMETIDINE TABLET ORAL 20101124 ANDA ANDA074890 Liberty Pharmaceuticals, Inc. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0440-1350_1ee65ac1-c6be-403f-bd22-0e3d72227937 0440-1350 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19890503 ANDA ANDA071611 Liberty Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0440-1380_b2770457-2c9e-4bf3-8846-96dd44eaa88d 0440-1380 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19710401 ANDA ANDA061454 Liberty Pharmaceuticals, Inc. DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0440-1385_dd8dd833-9fff-41b8-b4cb-24afcc15381b 0440-1385 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 Liberty Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0440-1466_2e3a1562-3641-4281-b681-5a7e9fcaf508 0440-1466 HUMAN OTC DRUG DOK EXTRA STRENGTH STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20020827 OTC MONOGRAPH NOT FINAL part334 Liberty Pharmaceuticals, Inc. DOCUSATE SODIUM 250 mg/1 0440-1481_20f0f4d8-a304-4cf7-af56-b8cd169d2e6f 0440-1481 HUMAN PRESCRIPTION DRUG Doxycyclate Hyclate Doxycycline Hyclate CAPSULE ORAL 19900901 ANDA ANDA062396 Liberty Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 0440-1595_d329bf4c-fe7a-4a86-aa7d-f80b29ac5d6f 0440-1595 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20080129 ANDA ANDA040774 Liberty Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0440-1617_5c7814c1-de25-4959-9ac2-6be8c8e5e9c3 0440-1617 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040787 Liberty Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0440-1652_8b106d6e-765c-47b5-8195-1f27ddda49d7 0440-1652 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 20130423 NDA NDA018858 Liberty Pharmaceuticals, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0440-1655_fd12cd86-bbb2-4a3d-81e3-6b46e5f11e37 0440-1655 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080937 Liberty Pharmaceuticals, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] 0440-1736_52fa42cf-efc4-4a01-ab61-2376c59799bb 0440-1736 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087128 Liberty Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 0440-1740_818d8de8-3e05-4714-882a-f68f6fc6e563 0440-1740 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Liberty Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0440-1771_b120cbd9-1ea1-4972-ab81-7c1385c734f2 0440-1771 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 Liberty Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0440-1795_fd60fa16-9bd2-4337-b52f-bf71d6e14714 0440-1795 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070027 Liberty Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0440-1796_fd60fa16-9bd2-4337-b52f-bf71d6e14714 0440-1796 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070033 Liberty Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0440-1852_8b3464cb-28f6-4c1c-be4a-6e3957c1e44b 0440-1852 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Liberty Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0440-1866_079d1cdd-ac23-48d6-b2ea-e19287ff77fd 0440-1866 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20070308 ANDA ANDA073652 Liberty Pharmaceuticals, Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 0440-2055_28f9d832-d025-4b3f-8f7e-8248acdbed11 0440-2055 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062936 Liberty Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 250 mg/1 0440-2070_90c23d3e-e53e-4773-b23c-6e1eef33c73e 0440-2070 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Liberty Pharmaceuticals, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 0440-2300_96b79fbb-56cb-4338-8c37-3150d381782e 0440-2300 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20130715 ANDA ANDA200172 Liberty Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 0440-2406_c552a71f-3a46-4281-a26f-1f503b7c90e2 0440-2406 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Liberty Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0440-7026_c688f809-80eb-4375-b1d5-1826d83c3c27 0440-7026 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 Liberty Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0440-7027_c688f809-80eb-4375-b1d5-1826d83c3c27 0440-7027 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089828 Liberty Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0440-7100_9d821181-fd97-4057-8fca-f7dc12ac89ad 0440-7100 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19880225 ANDA ANDA062884 Liberty Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0440-7135_184e3741-fc36-42fa-ac4f-05cb36c8e2ed 0440-7135 HUMAN OTC DRUG Adult Low Dose Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20070112 OTC MONOGRAPH FINAL part343 Liberty Pharmaceuticals, Inc. ASPIRIN 81 mg/1 0440-7183_4042eea7-af27-4571-997d-1f0cf5c516a9 0440-7183 HUMAN PRESCRIPTION DRUG Belladonna Alkaloids with Phenobartbital Belladonna Alkaloids with Phenobartbital TABLET ORAL 20001201 UNAPPROVED DRUG OTHER Liberty Pharmaceuticals, Inc. ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0440-7244_54407902-38cc-4020-bddc-0a67659edc33 0440-7244 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Liberty Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0440-7300_214768a2-e7b6-43b9-9a21-c4168f08eccf 0440-7300 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Liberty Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0440-7380_1f007574-56f1-4695-be3a-aeb85c41d466 0440-7380 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19900930 ANDA ANDA062286 Liberty Pharmaceuticals, Inc. DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0440-7384_6a458cdc-7859-4a91-bb5f-25e7bd91da7a 0440-7384 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19740930 ANDA ANDA084285 Liberty Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0440-7465_8424afc4-24c5-458f-accc-e2f199a63e3e 0440-7465 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20100915 OTC MONOGRAPH NOT FINAL part334 Liberty Pharmaceuticals, Inc. DOCUSATE SODIUM 100 mg/1 0440-7481_64b77fa9-3d66-4be9-a041-9cc0c6cffa09 0440-7481 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840507 ANDA ANDA062396 Liberty Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 0440-7483_a4ba92ff-e219-432b-b118-aba5737ce6b2 0440-7483 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 Liberty Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 0440-7559_93784027-63c0-413d-abfc-5c19aa23f06f 0440-7559 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Liberty Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0440-7605_bc3ce0e1-9a5d-42e2-8f7b-1002e8a29a3c 0440-7605 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 Liberty Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0440-7610_87ccd1a9-a92e-4d0d-9088-a011266af1a1 0440-7610 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA089160 Liberty Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0440-7655_295934bd-dc1c-463b-8daa-f653d6e95174 0440-7655 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19810714 ANDA ANDA087425 Liberty Pharmaceuticals, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] 0440-7674_5882cbb4-7d17-4c90-aff3-db64a7831f94 0440-7674 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Liberty Pharmaceuticals, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0440-7805_bfa210b4-ad7a-48c0-9724-ee990117fef4 0440-7805 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Liberty Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0440-7852_89ada3cc-d634-43fd-a873-a912d2c9ecd1 0440-7852 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Liberty Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0440-7868_eedf68fa-460e-4976-949e-033e0c8a381a 0440-7868 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20070308 ANDA ANDA073652 Liberty Pharmaceuticals, Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 0440-8055_dcd88916-a5bc-4735-badc-9b0d3cbff2ad 0440-8055 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062936 Liberty Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 250 mg/1 0440-8056_65771c7d-2af2-40bc-a504-0e4ee8affc07 0440-8056 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062935 Liberty Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 0440-8110_e6380429-d874-4ac1-adab-f2c25e94fd66 0440-8110 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Liberty Pharmaceuticals, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0440-8165_79e65904-d281-4e17-9ef2-640b731046a0 0440-8165 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA080356 Liberty Pharmaceuticals, Inc. PREDNISONE 5 mg/1 0440-8167_10fdf7d3-6572-4254-985c-acc1915c9dff 0440-8167 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 Liberty Pharmaceuticals, Inc. PREDNISONE 20 mg/1 0440-8190_dcc3673b-3133-410d-9cac-598f2ba01f43 0440-8190 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine Maleate TABLET ORAL 19980301 ANDA ANDA040268 Liberty Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0440-8195_3bd92043-d163-4465-9f23-8a776a2f5369 0440-8195 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20120717 ANDA ANDA040712 Liberty Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CIV 0440-8300_72a1666b-a50d-4ea5-9492-1b28ecc4bf70 0440-8300 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Liberty Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0440-8505_6900fe26-43eb-4ef1-ad0b-52eaabee63aa 0440-8505 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20000131 ANDA ANDA060704 Liberty Pharmaceuticals, Inc. TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 0456-0040_a87635bc-a599-42e1-b776-92207c225b0a 0456-0040 HUMAN PRESCRIPTION DRUG Thyrolar liothyronine sodium, LEVOTHYROXINE SODIUM TABLET ORAL 19691121 NDA NDA016807 Forest Laboratories, Inc LEVOTHYROXINE SODIUM; LIOTHYRONINE SODIUM 12.5; 3.1 ug/1; ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient],l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0456-0045_a87635bc-a599-42e1-b776-92207c225b0a 0456-0045 HUMAN PRESCRIPTION DRUG Thyrolar liothyronine sodium, LEVOTHYROXINE SODIUM TABLET ORAL 19691121 NDA NDA016807 Forest Laboratories, Inc LEVOTHYROXINE SODIUM; LIOTHYRONINE SODIUM 25; 6.25 ug/1; ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient],l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0456-0050_a87635bc-a599-42e1-b776-92207c225b0a 0456-0050 HUMAN PRESCRIPTION DRUG Thyrolar liothyronine sodium, LEVOTHYROXINE SODIUM TABLET ORAL 19691121 NDA NDA016807 Forest Laboratories, Inc LEVOTHYROXINE SODIUM; LIOTHYRONINE SODIUM 50; 12.5 ug/1; ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient],l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0456-0055_a87635bc-a599-42e1-b776-92207c225b0a 0456-0055 HUMAN PRESCRIPTION DRUG Thyrolar liothyronine sodium, LEVOTHYROXINE SODIUM TABLET ORAL 19691121 NDA NDA016807 Forest Laboratories, Inc LEVOTHYROXINE SODIUM; LIOTHYRONINE SODIUM 100; 25 ug/1; ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient],l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0456-0060_a87635bc-a599-42e1-b776-92207c225b0a 0456-0060 HUMAN PRESCRIPTION DRUG Thyrolar liothyronine sodium, LEVOTHYROXINE SODIUM TABLET ORAL 19691121 NDA NDA016807 Forest Laboratories, Inc LEVOTHYROXINE SODIUM; LIOTHYRONINE SODIUM 150; 37.5 ug/1; ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient],l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0456-0095_1f01bade-c284-4d32-b794-acede13dfae7 0456-0095 HUMAN PRESCRIPTION DRUG Daliresp roflumilast TABLET ORAL 20110228 NDA NDA022522 Forest Laboratories, Inc. ROFLUMILAST 500 ug/1 Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA] 0456-0400_0e0a10bf-7edf-4573-b8a1-586c2d41d4df 0456-0400 HUMAN PRESCRIPTION DRUG Teflaro ceftaroline fosamil POWDER, FOR SOLUTION INTRAVENOUS 20101029 NDA NDA200327 Forest Laboratories, Inc. CEFTAROLINE FOSAMIL 400 mg/20mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0456-0457_97b19e2a-ec3b-48ef-b66f-385189759933 0456-0457 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Forest Laboratories, Inc THYROID, PORCINE 15 mg/1 0456-0458_97b19e2a-ec3b-48ef-b66f-385189759933 0456-0458 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Forest Laboratories, Inc THYROID, PORCINE 30 mg/1 0456-0459_97b19e2a-ec3b-48ef-b66f-385189759933 0456-0459 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Forest Laboratories, Inc THYROID, PORCINE 60 mg/1 0456-0460_97b19e2a-ec3b-48ef-b66f-385189759933 0456-0460 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Forest Laboratories, Inc THYROID, PORCINE 90 mg/1 0456-0461_97b19e2a-ec3b-48ef-b66f-385189759933 0456-0461 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Forest Laboratories, Inc THYROID, PORCINE 120 mg/1 0456-0462_97b19e2a-ec3b-48ef-b66f-385189759933 0456-0462 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Forest Laboratories, Inc THYROID, PORCINE 180 mg/1 0456-0463_97b19e2a-ec3b-48ef-b66f-385189759933 0456-0463 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Forest Laboratories, Inc THYROID, PORCINE 240 mg/1 0456-0464_97b19e2a-ec3b-48ef-b66f-385189759933 0456-0464 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Forest Laboratories, Inc THYROID, PORCINE 300 mg/1 0456-0600_0e0a10bf-7edf-4573-b8a1-586c2d41d4df 0456-0600 HUMAN PRESCRIPTION DRUG Teflaro ceftaroline fosamil POWDER, FOR SOLUTION INTRAVENOUS 20101029 NDA NDA200327 Forest Laboratories, Inc. CEFTAROLINE FOSAMIL 600 mg/20mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0456-0679_ff3214a0-5dd5-444a-a34a-af9b69ef7b81 0456-0679 HUMAN PRESCRIPTION DRUG Esgic-Plus butalbital, acetaminophen and caffeine CAPSULE ORAL 19960813 20150810 ANDA ANDA040085 Forest Laboratories, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0456-0800_f67d3861-6244-4e51-ba0a-d5d0a07cb344 0456-0800 HUMAN PRESCRIPTION DRUG Tudorza Pressair aclidinium bromide INHALANT RESPIRATORY (INHALATION) 20120723 NDA NDA202450 Forest Laboratories, Inc. ACLIDINIUM BROMIDE 400 ug/1 0456-1100_5fea3e84-452f-4ba9-a8bd-e21a566512d4 0456-1100 HUMAN PRESCRIPTION DRUG VIIBRYD vilazodone hydrochloride KIT ORAL 20110429 NDA NDA022567 Forest Laboratories, Inc. 0456-1110_5fea3e84-452f-4ba9-a8bd-e21a566512d4 0456-1110 HUMAN PRESCRIPTION DRUG VIIBRYD vilazodone hydrochloride TABLET ORAL 20110429 NDA NDA022567 Forest Laboratories, Inc. VILAZODONE HYDROCHLORIDE 10 mg/1 0456-1120_5fea3e84-452f-4ba9-a8bd-e21a566512d4 0456-1120 HUMAN PRESCRIPTION DRUG VIIBRYD vilazodone hydrochloride TABLET ORAL 20110429 NDA NDA022567 Forest Laboratories, Inc. VILAZODONE HYDROCHLORIDE 20 mg/1 0456-1140_5fea3e84-452f-4ba9-a8bd-e21a566512d4 0456-1140 HUMAN PRESCRIPTION DRUG VIIBRYD vilazodone hydrochloride TABLET ORAL 20110429 NDA NDA022567 Forest Laboratories, Inc. VILAZODONE HYDROCHLORIDE 40 mg/1 0456-1201_4a3dd6a5-da76-4001-88d8-e10ad22c0368 0456-1201 HUMAN PRESCRIPTION DRUG Linzess linaclotide CAPSULE, GELATIN COATED ORAL 20120830 NDA NDA202811 Forest Laboratories, Inc. LINACLOTIDE 145 ug/1 Guanylate Cyclase-C Agonist [EPC],Guanylate Cyclase Activators [MoA] 0456-1202_4a3dd6a5-da76-4001-88d8-e10ad22c0368 0456-1202 HUMAN PRESCRIPTION DRUG Linzess linaclotide CAPSULE, GELATIN COATED ORAL 20120830 NDA NDA202811 Forest Laboratories, Inc. LINACLOTIDE 290 ug/1 Guanylate Cyclase-C Agonist [EPC],Guanylate Cyclase Activators [MoA] 0456-1402_ffaf66c9-0d47-4768-a3fa-a5f09fe6c4f5 0456-1402 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20080122 NDA NDA021742 Forest laboratories, Inc. NEBIVOLOL HYDROCHLORIDE 2.5 mg/1 0456-1405_ffaf66c9-0d47-4768-a3fa-a5f09fe6c4f5 0456-1405 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20080122 NDA NDA021742 Forest laboratories, Inc. NEBIVOLOL HYDROCHLORIDE 5 mg/1 0456-1410_ffaf66c9-0d47-4768-a3fa-a5f09fe6c4f5 0456-1410 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20080122 NDA NDA021742 Forest laboratories, Inc. NEBIVOLOL HYDROCHLORIDE 10 mg/1 0456-1420_ffaf66c9-0d47-4768-a3fa-a5f09fe6c4f5 0456-1420 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20080122 NDA NDA021742 Forest laboratories, Inc. NEBIVOLOL HYDROCHLORIDE 20 mg/1 0456-1500_63e2058f-10dc-448f-bdf9-814c185e2a50 0456-1500 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride KIT ORAL 20090417 NDA NDA022256 Forest Laboratories, Inc. 0456-1510_63e2058f-10dc-448f-bdf9-814c185e2a50 0456-1510 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Forest Laboratories, Inc. MILNACIPRAN HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0456-1512_63e2058f-10dc-448f-bdf9-814c185e2a50 0456-1512 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Forest Laboratories, Inc. MILNACIPRAN HYDROCHLORIDE 12.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0456-1525_63e2058f-10dc-448f-bdf9-814c185e2a50 0456-1525 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Forest Laboratories, Inc. MILNACIPRAN HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0456-1550_63e2058f-10dc-448f-bdf9-814c185e2a50 0456-1550 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Forest Laboratories, Inc. MILNACIPRAN HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0456-2005_803268db-d772-4790-92d0-8a7a531e7f52 0456-2005 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Forest Laboratories, Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0456-2010_803268db-d772-4790-92d0-8a7a531e7f52 0456-2010 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Forest Laboratories, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0456-2020_803268db-d772-4790-92d0-8a7a531e7f52 0456-2020 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Forest Laboratories, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0456-2101_803268db-d772-4790-92d0-8a7a531e7f52 0456-2101 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE SOLUTION ORAL 20021126 NDA NDA021365 Forest Laboratories, Inc. ESCITALOPRAM OXALATE 5 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0456-2202_8d38c57f-961d-4ac2-bbfd-ef9c4789a281 0456-2202 HUMAN PRESCRIPTION DRUG Fetzima LEVOMILNACIPRAN HYDROCHLORIDE KIT ORAL 20130725 NDA NDA204168 Forest Laboratories, Inc. 0456-2212_8d38c57f-961d-4ac2-bbfd-ef9c4789a281 0456-2212 HUMAN PRESCRIPTION DRUG Fetzima LEVOMILNACIPRAN HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20130725 NDA NDA204168 Forest Laboratories, Inc. LEVOMILNACIPRAN HYDROCHLORIDE 120 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0456-2220_8d38c57f-961d-4ac2-bbfd-ef9c4789a281 0456-2220 HUMAN PRESCRIPTION DRUG Fetzima LEVOMILNACIPRAN HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20130725 NDA NDA204168 Forest Laboratories, Inc. LEVOMILNACIPRAN HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0456-2240_8d38c57f-961d-4ac2-bbfd-ef9c4789a281 0456-2240 HUMAN PRESCRIPTION DRUG Fetzima LEVOMILNACIPRAN HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20130725 NDA NDA204168 Forest Laboratories, Inc. LEVOMILNACIPRAN HYDROCHLORIDE 40 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0456-2280_8d38c57f-961d-4ac2-bbfd-ef9c4789a281 0456-2280 HUMAN PRESCRIPTION DRUG Fetzima LEVOMILNACIPRAN HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20130725 NDA NDA204168 Forest Laboratories, Inc. LEVOMILNACIPRAN HYDROCHLORIDE 80 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0456-2405_5009d42a-376c-493a-88d2-b29f275c6c44 0456-2405 HUMAN PRESCRIPTION DRUG SAPHRIS Asenapine Maleate TABLET SUBLINGUAL 20130930 NDA NDA022117 Forest Laboratories, Inc. ASENAPINE MALEATE 5 mg/1 Atypical Antipsychotic [EPC] 0456-2410_5009d42a-376c-493a-88d2-b29f275c6c44 0456-2410 HUMAN PRESCRIPTION DRUG SAPHRIS Asenapine Maleate TABLET SUBLINGUAL 20130930 NDA NDA022117 Forest Laboratories, Inc. ASENAPINE MALEATE 10 mg/1 Atypical Antipsychotic [EPC] 0456-3200_4f60a39c-8dd1-4237-8b91-aac591402ead 0456-3200 HUMAN PRESCRIPTION DRUG Namenda Memantine Hydrochloride KIT ORAL 20031016 NDA NDA021487 Forest Laboratories, Inc. 0456-3202_4f60a39c-8dd1-4237-8b91-aac591402ead 0456-3202 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride SOLUTION ORAL 20050418 NDA NDA021627 Forest Laboratories, Inc. MEMANTINE HYDROCHLORIDE 2 mg/mL NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 0456-3205_4f60a39c-8dd1-4237-8b91-aac591402ead 0456-3205 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20031016 NDA NDA021487 Forest Laboratories, Inc. MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 0456-3210_4f60a39c-8dd1-4237-8b91-aac591402ead 0456-3210 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20031016 NDA NDA021487 Forest Laboratories, Inc. MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 0456-3330_b5bca50f-5077-46d1-bb1d-15436f86e24c 0456-3330 HUMAN PRESCRIPTION DRUG Campral acamprosate calcium TABLET, DELAYED RELEASE ORAL 20050111 NDA NDA021431 Forest Laboratories, Inc. ACAMPROSATE CALCIUM 333 mg/1 0456-3400_bed4d4da-4d41-4a9c-a813-3f2c98608c09 0456-3400 HUMAN PRESCRIPTION DRUG Namenda XR memantine hydrochloride KIT ORAL 20110915 NDA NDA022525 Forest Laboratories, Inc. 0456-3407_bed4d4da-4d41-4a9c-a813-3f2c98608c09 0456-3407 HUMAN PRESCRIPTION DRUG Namenda XR memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 NDA NDA022525 Forest Laboratories, Inc. MEMANTINE HYDROCHLORIDE 7 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 0456-3414_bed4d4da-4d41-4a9c-a813-3f2c98608c09 0456-3414 HUMAN PRESCRIPTION DRUG Namenda XR memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 NDA NDA022525 Forest Laboratories, Inc. MEMANTINE HYDROCHLORIDE 14 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 0456-3421_bed4d4da-4d41-4a9c-a813-3f2c98608c09 0456-3421 HUMAN PRESCRIPTION DRUG Namenda XR memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 NDA NDA022525 Forest Laboratories, Inc. MEMANTINE HYDROCHLORIDE 21 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 0456-3428_bed4d4da-4d41-4a9c-a813-3f2c98608c09 0456-3428 HUMAN PRESCRIPTION DRUG Namenda XR memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 NDA NDA022525 Forest Laboratories, Inc. MEMANTINE HYDROCHLORIDE 28 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 0456-4010_d0ce418d-d88a-49b7-8a32-7dde9967e3b8 0456-4010 HUMAN PRESCRIPTION DRUG Celexa citalopram hydrobromide TABLET, FILM COATED ORAL 19980717 NDA NDA020822 Forest Laboratories, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0456-4020_d0ce418d-d88a-49b7-8a32-7dde9967e3b8 0456-4020 HUMAN PRESCRIPTION DRUG Celexa citalopram hydrobromide TABLET, FILM COATED ORAL 19980717 NDA NDA020822 Forest Laboratories, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0456-4040_d0ce418d-d88a-49b7-8a32-7dde9967e3b8 0456-4040 HUMAN PRESCRIPTION DRUG Celexa citalopram hydrobromide TABLET, FILM COATED ORAL 19980717 NDA NDA020822 Forest Laboratories, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0456-4123_3a496378-bf43-4d17-b430-00b9264db488 0456-4123 HUMAN PRESCRIPTION DRUG Cervidil dinoprostone INSERT, EXTENDED RELEASE VAGINAL 19950519 NDA NDA020411 Forest Laboratories, Inc. DINOPROSTONE 10 mg/1 0456-4300_7034cd1e-7bfb-49e0-bb44-a739009dff41 0456-4300 HUMAN PRESCRIPTION DRUG Monurol Fosfomycin tromethamine POWDER ORAL 19961219 NDA NDA050717 Forest Laboratories FOSFOMYCIN TROMETHAMINE 3 g/1 0462-0153_0ff9b01c-0fce-406f-8049-9d88d38955d9 0462-0153 HUMAN PRESCRIPTION DRUG Pandel Hydrocortisone Probutate CREAM TOPICAL 19970228 NDA NDA020453 PharmaDerm, A division of Nycomed US Inc. HYDROCORTISONE PROBUTATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0462-0162_39ba18dc-0927-4dd5-adc6-baacc08ce3a1 0462-0162 HUMAN PRESCRIPTION DRUG Temovate clobetasol propionate OINTMENT TOPICAL 19851227 NDA NDA019323 PharmaDerm A division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0462-0163_39ba18dc-0927-4dd5-adc6-baacc08ce3a1 0462-0163 HUMAN PRESCRIPTION DRUG Temovate clobetasol propionate CREAM TOPICAL 19851227 NDA NDA019322 PharmaDerm A division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0462-0263_fe620bc3-2873-4439-aa92-442fd0313940 0462-0263 HUMAN PRESCRIPTION DRUG Aclovate alclometasone dipropionate CREAM TOPICAL 20090901 ANDA ANDA076973 Pharmaderm, A division of Nycomed US Inc. ALCLOMETASONE DIPROPIONATE .5 mg/g 0462-0264_fe620bc3-2873-4439-aa92-442fd0313940 0462-0264 HUMAN PRESCRIPTION DRUG Aclovate alclometasone dipropionate OINTMENT TOPICAL 20091001 ANDA ANDA076884 Pharmaderm, A division of Nycomed US Inc. ALCLOMETASONE DIPROPIONATE .5 mg/g 0462-0269_20bdd08b-0d3d-4ad0-8da8-179111d45ecd 0462-0269 HUMAN PRESCRIPTION DRUG Temovate Scalp Application Clobetasol Propionate SOLUTION TOPICAL 19900222 NDA NDA019966 PharmaDerm, A division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0462-0277_c45df254-3691-4e8c-adb6-3bb3c8039472 0462-0277 HUMAN PRESCRIPTION DRUG Clindamax Clindamycin Phosphate CREAM VAGINAL 20091029 ANDA ANDA065139 PHARMADERM. A division of Nycomed US Inc. CLINDAMYCIN PHOSPHATE 20 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0462-0293_7675b274-767c-48c5-97ef-a53cbd5be28a 0462-0293 HUMAN PRESCRIPTION DRUG Temovate clobetasol propionate GEL TOPICAL 19940429 NDA NDA020337 PharmaDerm, A division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0462-0301_c6b9308b-68fb-460b-ac18-144de460339d 0462-0301 HUMAN PRESCRIPTION DRUG TEMOVATE clobetasol propionate CREAM TOPICAL 19940617 NDA NDA020340 PharmaDerm a division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0462-0346_424093cd-d1df-4c1d-ab48-e4305214a65e 0462-0346 HUMAN PRESCRIPTION DRUG Zazole terconazole CREAM VAGINAL 20050218 ANDA ANDA076712 PharmaDerm A division of Fougera Pharmaceuticals Inc. TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0462-0347_f06b64ca-9308-41b5-b164-508e4c94191b 0462-0347 HUMAN PRESCRIPTION DRUG Zazole terconazole CREAM VAGINAL 20091002 NDA NDA021735 Pharmaderm, A division of Nycomed US Inc. TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0462-0348_cfbfbc98-a8e5-42fa-b83f-85719d109aa4 0462-0348 HUMAN PRESCRIPTION DRUG Zazole TERCONAZOLE SUPPOSITORY VAGINAL 20060712 ANDA ANDA076850 PharmaDerm a division of Fougera Pharmaceuticals Inc. TERCONAZOLE 80 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0462-0358_9770c9c6-3b97-43c6-9c30-5d454c938ede 0462-0358 HUMAN PRESCRIPTION DRUG Oxistat oxiconazole nitrate CREAM TOPICAL 20060125 NDA NDA019828 PharmaDerm, A division of Nycomed US Inc. OXICONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0462-0359_9770c9c6-3b97-43c6-9c30-5d454c938ede 0462-0359 HUMAN PRESCRIPTION DRUG Oxistat oxiconazole nitrate LOTION TOPICAL 20060125 NDA NDA020209 PharmaDerm, A division of Nycomed US Inc. OXICONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0462-0390_7dad7945-9f1c-46c1-8ecf-1bd81cd918bc 0462-0390 HUMAN PRESCRIPTION DRUG ClindaMax clindamycin phosphate GEL TOPICAL 20091001 ANDA ANDA064160 PharmaDerm, A division of Nycomed US Inc. CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0462-0391_0ebfdc10-471e-41d8-9396-b1e2a0760b7e 0462-0391 HUMAN PRESCRIPTION DRUG ClindaMax Lotion clindamycin phosphate SUSPENSION TOPICAL 20020131 ANDA ANDA065067 PharmaDerm, A division of Nycomed US Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0462-0392_8e63984c-c59a-4c5c-b52f-465fb6e17a67 0462-0392 HUMAN PRESCRIPTION DRUG LoKara desonide LOTION TOPICAL 20020319 ANDA ANDA075860 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. DESONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0462-0394_e1ccac89-bea8-426a-87f6-164f1046e238 0462-0394 HUMAN PRESCRIPTION DRUG ApexiCon diflorasone diacetate ointment OINTMENT TOPICAL 20090930 ANDA ANDA075374 Pharmaderm, A division of Nycomed US Inc. DIFLORASONE DIACETATE .5 mg/g 0462-0395_264c1cf0-cb3b-47ad-9cb3-0a9503f4863f 0462-0395 HUMAN PRESCRIPTION DRUG ApexiCon E diflorasone diacetate CREAM TOPICAL 20090930 ANDA ANDA076263 PharmaDerm, A division of Nycomed US Inc. DIFLORASONE DIACETATE .5 mg/g 0462-0434_edc17b37-0b6f-417f-88fd-79f0bbf6c46e 0462-0434 HUMAN PRESCRIPTION DRUG Cutivate fluticasone propionate LOTION TOPICAL 20091005 NDA NDA021152 PharmaDerm, A division of Nycomed US Inc. FLUTICASONE PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0463-1118_dc744432-86ed-48ad-b4a2-3c54a37a1543 0463-1118 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091228 ANDA ANDA090354 C.O. Truxton, Inc. AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0463-2013_7267994f-589b-407f-ba8b-7971a0d07a58 0463-2013 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20130114 ANDA ANDA065103 C.O. Truxton, Inc. DOXYCYCLINE HYCLATE 100 mg/1 0463-6000_e5733d31-1d4a-46b5-9131-4ef99f7b6a84 0463-6000 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20131125 ANDA ANDA062269 C.O. Truxton, Inc. DOXYCYCLINE HYCLATE 100 mg/1 0463-6050_0bb7f0d2-2fb8-4e6f-a96e-cc0e99b3e150 0463-6050 HUMAN PRESCRIPTION DRUG benzphetamine hydrochloride benzphetamine hydrochloride TABLET ORAL 20111101 ANDA ANDA090473 C.O. Truxton, Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 0463-6080_d8b9cc7c-7d73-47ae-868d-436039bb6794 0463-6080 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20100615 ANDA ANDA040644 C.O. Truxton, Inc. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 0463-6141_7f7b221e-0c33-4295-8d8e-cec1cda84c59 0463-6141 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA087342 C.O. Truxton, Inc. PREDNISONE 20 mg/1 0463-6145_ba250e94-ae3b-47ab-bf2e-cf7ea3a47d0a 0463-6145 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120301 UNAPPROVED DRUG OTHER C.O. Truxton, Inc. PHENOBARBITAL 30 mg/1 CIV 0463-6151_ba250e94-ae3b-47ab-bf2e-cf7ea3a47d0a 0463-6151 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120301 UNAPPROVED DRUG OTHER C.O. Truxton, Inc. PHENOBARBITAL 60 mg/1 CIV 0463-6155_7f7b221e-0c33-4295-8d8e-cec1cda84c59 0463-6155 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 C.O. Truxton, Inc. PREDNISONE 5 mg/1 0463-6160_ba250e94-ae3b-47ab-bf2e-cf7ea3a47d0a 0463-6160 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120301 UNAPPROVED DRUG OTHER C.O. Truxton, Inc. PHENOBARBITAL 15 mg/1 CIV 0463-6170_ba250e94-ae3b-47ab-bf2e-cf7ea3a47d0a 0463-6170 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120301 UNAPPROVED DRUG OTHER C.O. Truxton, Inc. PHENOBARBITAL 100 mg/1 CIV 0463-6351_b66b20e0-3490-4e85-b626-b5c50d677c8f 0463-6351 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 C.O. Truxton, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0463-6352_b66b20e0-3490-4e85-b626-b5c50d677c8f 0463-6352 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 C.O. Truxton, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0463-6354_b66b20e0-3490-4e85-b626-b5c50d677c8f 0463-6354 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 C.O. Truxton, Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 0463-7500_cd472295-183d-400a-89eb-77d03c943c94 0463-7500 HUMAN PRESCRIPTION DRUG phendimetrazine tartrate phendimetrazine tartrate TABLET ORAL 20000329 ANDA ANDA089452 C.O. Truxton, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 0463-8000_b06b1320-d88d-4fd3-bf08-613d44d26504 0463-8000 HUMAN PRESCRIPTION DRUG phendimetrazine tartrate phendimetrazine tartrate TABLET ORAL 20000406 ANDA ANDA089452 C.O. Truxton, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 0463-8500_d34a4bba-1c0c-41dc-9c54-36fbb6960339 0463-8500 HUMAN PRESCRIPTION DRUG phendimetrazine tartrate phendimetrazine tartrate TABLET ORAL 20010726 ANDA ANDA089452 C.O. Truxton, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 0469-0125_a2ea19a7-233c-43f5-989d-d6b1f78b7bcd 0469-0125 HUMAN PRESCRIPTION DRUG Xtandi enzalutamide CAPSULE ORAL 20120831 NDA NDA203415 Astellas Pharma US, Inc. ENZALUTAMIDE 40 mg/1 Androgen Receptor Inhibitor [EPC],Androgen Receptor Antagonists [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] 0469-0607_b19e1237-84b0-4f2d-9f91-5b5d785a8d25 0469-0607 HUMAN PRESCRIPTION DRUG Prograf Tacrolimus CAPSULE, GELATIN COATED ORAL 19980824 NDA NDA050708 Astellas Pharma US, Inc. TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0469-0617_b19e1237-84b0-4f2d-9f91-5b5d785a8d25 0469-0617 HUMAN PRESCRIPTION DRUG Prograf Tacrolimus CAPSULE, GELATIN COATED ORAL 19940408 NDA NDA050708 Astellas Pharma US, Inc. TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0469-0647_eb7f57f3-f54a-4198-8c5c-1171de882d94 0469-0647 HUMAN PRESCRIPTION DRUG ASTAGRAF XL tacrolimus extended-release capsules CAPSULE, COATED, EXTENDED RELEASE ORAL 20130719 NDA NDA204096 Astellas Pharma US, Inc. TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0469-0657_b19e1237-84b0-4f2d-9f91-5b5d785a8d25 0469-0657 HUMAN PRESCRIPTION DRUG Prograf Tacrolimus CAPSULE, GELATIN COATED ORAL 19940408 NDA NDA050708 Astellas Pharma US, Inc. TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0469-0677_eb7f57f3-f54a-4198-8c5c-1171de882d94 0469-0677 HUMAN PRESCRIPTION DRUG ASTAGRAF XL tacrolimus extended-release capsules CAPSULE, COATED, EXTENDED RELEASE ORAL 20130719 NDA NDA204096 Astellas Pharma US, Inc. TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0469-0687_eb7f57f3-f54a-4198-8c5c-1171de882d94 0469-0687 HUMAN PRESCRIPTION DRUG ASTAGRAF XL tacrolimus extended-release capsules CAPSULE, COATED, EXTENDED RELEASE ORAL 20130719 NDA NDA204096 Astellas Pharma US, Inc. TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0469-0871_08f24e07-c578-4b8b-af70-c8a0926ba91c 0469-0871 HUMAN PRESCRIPTION DRUG Adenoscan adenosine SOLUTION INTRAVENOUS 19950518 NDA NDA020059 Astellas Pharma US, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 0469-2601_dcf7c82b-2af6-474c-9c6b-a0ccdd3bbe7f 0469-2601 HUMAN PRESCRIPTION DRUG Myrbetriq mirabegron TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120628 NDA NDA202611 Astellas Pharma US, Inc. MIRABEGRON 25 mg/1 beta3-Adrenergic Agonist [EPC],Adrenergic beta3-Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0469-2602_dcf7c82b-2af6-474c-9c6b-a0ccdd3bbe7f 0469-2602 HUMAN PRESCRIPTION DRUG Myrbetriq mirabegron TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120628 NDA NDA202611 Astellas Pharma US, Inc. MIRABEGRON 50 mg/1 beta3-Adrenergic Agonist [EPC],Adrenergic beta3-Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0469-3016_b19e1237-84b0-4f2d-9f91-5b5d785a8d25 0469-3016 HUMAN PRESCRIPTION DRUG Prograf Tacrolimus INJECTION, SOLUTION INTRAVENOUS 19940408 NDA NDA050709 Astellas Pharma US, Inc. TACROLIMUS 5 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0469-3051_3ab7fe3b-149e-4ff5-826a-1e23a6d39b55 0469-3051 HUMAN PRESCRIPTION DRUG AmBisome amphotericin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19970811 NDA NDA050740 Astellas Pharma US, Inc. AMPHOTERICIN B 50 mg/12.5mL Lipid-based Polyene Antifungal [EPC],Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 0469-3211_bc234dd7-5221-4a68-b153-aa0393c75bbf 0469-3211 HUMAN PRESCRIPTION DRUG Mycamine Micafungin sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141201 NDA NDA021506 Astellas Pharma US, Inc. MICAFUNGIN SODIUM 20 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] 0469-3211_be62349e-a4fe-4eec-bb2b-36e168d56a2d 0469-3211 HUMAN PRESCRIPTION DRUG MYCAMINE micafungin sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20060627 NDA NDA021506 Astellas Pharma US, Inc. MICAFUNGIN SODIUM 20 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] 0469-3250_bc234dd7-5221-4a68-b153-aa0393c75bbf 0469-3250 HUMAN PRESCRIPTION DRUG Mycamine Micafungin sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141201 NDA NDA021506 Astellas Pharma US, Inc. MICAFUNGIN SODIUM 10 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] 0469-3250_be62349e-a4fe-4eec-bb2b-36e168d56a2d 0469-3250 HUMAN PRESCRIPTION DRUG MYCAMINE micafungin sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20050316 NDA NDA021506 Astellas Pharma US, Inc. MICAFUNGIN SODIUM 10 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] 0469-3525_7f97eb3c-50f3-4767-8581-9d6f4cac3e91 0469-3525 HUMAN PRESCRIPTION DRUG Vibativ telavancin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091105 NDA NDA022110 Astellas Pharma US Inc. TELAVANCIN HYDROCHLORIDE 250 mg/1 0469-3575_7f97eb3c-50f3-4767-8581-9d6f4cac3e91 0469-3575 HUMAN PRESCRIPTION DRUG Vibativ telavancin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091105 NDA NDA022110 Astellas Pharma US Inc. TELAVANCIN HYDROCHLORIDE 750 mg/1 0469-5201_17cc7208-9df0-4f45-921c-54b8c16882d7 0469-5201 HUMAN PRESCRIPTION DRUG Protopic Tacrolimus OINTMENT TOPICAL 20001208 NDA NDA050777 Astellas Pharma US Inc. TACROLIMUS .3 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0469-5202_17cc7208-9df0-4f45-921c-54b8c16882d7 0469-5202 HUMAN PRESCRIPTION DRUG Protopic Tacrolimus OINTMENT TOPICAL 20001208 NDA NDA050777 Astellas Pharma US Inc. TACROLIMUS 1 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0469-6501_c8e8b02a-e113-4275-9bb5-9b1618ddbea0 0469-6501 HUMAN PRESCRIPTION DRUG Lexiscan regadenoson INJECTION, SOLUTION INTRAVENOUS 20080410 NDA NDA022161 Astellas Pharma US, Inc. REGADENOSON .08 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 0469-8234_c617444d-edaf-4b37-8ea1-de8d411c9f44 0469-8234 HUMAN PRESCRIPTION DRUG Adenocard adenosine SOLUTION INTRAVENOUS 19891030 NDA NDA019937 Astellas Pharma US, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 0472-0013_45541f8f-b5ae-4826-916f-3670d7c3c374 0472-0013 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin SUSPENSION ORAL 20070726 ANDA ANDA065394 Actavis Mid Atlantic LLC GRISEOFULVIN 125 mg/5mL Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 0472-0066_d4a6b075-aa43-4784-b019-b1599f0dbd59 0472-0066 HUMAN OTC DRUG Hair Regrowth Treatment minoxidil SOLUTION TOPICAL 20000101 ANDA ANDA074588 Actavis Mid Atlantic LLC MINOXIDIL 2 g/100mL 0472-0082_782d5d91-94cf-42fe-865a-a7ecf4da8de6 0472-0082 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir SUSPENSION ORAL 20020903 ANDA ANDA074738 Actavis Mid Atlantic LLC ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0472-0094_7a70404b-5f49-4fb5-b6db-cb31f8aa987c 0472-0094 HUMAN OTC DRUG Hair Regrowth Treatment For Men minoxidil SOLUTION TOPICAL 20001117 ANDA ANDA075518 Actavis Mid Atlantic LLC MINOXIDIL 50 mg/mL 0472-0117_8f65b6e4-92c6-4875-b216-4b3ae2a291d8 0472-0117 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 19980501 NDA AUTHORIZED GENERIC NDA020404 Actavis Mid Atlantic LLC TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0472-0126_6babb313-a0df-4cac-bdcb-dec79a4051c9 0472-0126 HUMAN PRESCRIPTION DRUG adapalene adapalene GEL TOPICAL 20141027 ANDA ANDA201000 Actavis Pharma, Inc. ADAPALENE 3 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0472-0163_69a911e4-927e-4953-af34-0ad2cef1eec9 0472-0163 HUMAN PRESCRIPTION DRUG Nystatin Nystatin CREAM TOPICAL 20100721 ANDA ANDA062949 Actavis Mid Atlantic LLC NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 0472-0166_41a98c36-0d72-4cfe-a5fa-ba39df58439b 0472-0166 HUMAN PRESCRIPTION DRUG Nystatin Nystatin OINTMENT TOPICAL 20020903 ANDA ANDA062840 Actavis Mid Atlantic LLC NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 0472-0179_c7e2f711-7e1d-4bc8-b4e2-c19f2de8023a 0472-0179 HUMAN OTC DRUG TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sulfate OINTMENT TOPICAL 20030101 OTC MONOGRAPH FINAL part333B Actavis Mid Atlantic LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 0472-0220_6903173d-f13b-4e6d-bbe4-6cccaeb6a61c 0472-0220 HUMAN OTC DRUG Clotrimazole clotrimazole CREAM VAGINAL 20030812 ANDA ANDA074165 Actavis Mid Atlantic LLC CLOTRIMAZOLE 1 g/100g 0472-0235_90764e97-7fa6-4f8c-8087-323b23ddc1be 0472-0235 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090115 ANDA ANDA078976 Actavis Mid Atlantic LLC LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0472-0242_fc7b7123-1b57-4010-a534-3e3adc5a75ce 0472-0242 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20041130 ANDA ANDA074806 Actavis Mid Atlantic LLC PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] 0472-0321_af026b48-2834-4cf8-8360-8da90e184940 0472-0321 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20020103 ANDA ANDA087795 Actavis Mid Atlantic LLC HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0472-0337_6c742084-083f-45e8-bfbd-e571b77551dc 0472-0337 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20020930 ANDA ANDA089682 Actavis Mid Atlantic LLC HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0472-0339_7a2fb192-c352-406f-9a3e-d68d053656d8 0472-0339 HUMAN OTC DRUG Hydrocortisone with Aloe Maximum Strength Hydrocortisone CREAM TOPICAL 19980708 OTC MONOGRAPH NOT FINAL part348 Actavis Mid Atlantic LLC HYDROCORTISONE 1 g/100g 0472-0343_b43f8320-10eb-4c15-8488-09b971ac007a 0472-0343 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 19970801 OTC MONOGRAPH NOT FINAL part348 Actavis Mid Atlantic LLC HYDROCORTISONE 1 g/100g 0472-0345_9c5b6789-f185-4a89-88f3-0903bde6a6d3 0472-0345 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone OINTMENT TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part348 Actavis Mid Atlantic LLC HYDROCORTISONE 1 g/100g 0472-0370_cde26ab8-e07c-4264-aab8-c8a2559f8719 0472-0370 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate CREAM TOPICAL 20020901 ANDA ANDA070050 Actavis Mid Atlantic LLC BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0472-0371_cde26ab8-e07c-4264-aab8-c8a2559f8719 0472-0371 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate OINTMENT TOPICAL 20020901 ANDA ANDA070051 Actavis Mid Atlantic LLC BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0472-0379_bf85f2b7-3d4c-4ea7-ba8f-18993c3ef329 0472-0379 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20070103 ANDA ANDA076002 Actavis Mid Atlantic LLC BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE .5; 10 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0472-0380_362287f2-505b-4fa3-bd45-b73c841a982b 0472-0380 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate betamethasone dipropionate CREAM TOPICAL 20020903 ANDA ANDA070885 Actavis Mid Atlantic LLC BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0472-0381_939d2c7f-0b9f-4de6-943f-54835756e3be 0472-0381 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate OINTMENT TOPICAL 20020826 ANDA ANDA071012 Actavis Mid Atlantic LLC BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0472-0382_11e9f596-fd0e-414d-8828-f27859834294 0472-0382 HUMAN PRESCRIPTION DRUG BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED TOPICAL 20070103 ANDA ANDA074304 Actavis Mid Atlantic LLC BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0472-0383_10957b03-072c-4a74-81bf-0d3e99bfb93a 0472-0383 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SOLUTION ORAL 20070315 ANDA ANDA076124 Actavis Mid Atlantic LLC RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0472-0403_320c352f-1585-4820-8a5b-e87124e8c478 0472-0403 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate SHAMPOO TOPICAL 20120103 ANDA ANDA078854 Actavis Mid Atlantic LLC CLOBETASOL PROPIONATE .05 g/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0472-0404_35cd2027-226e-432e-852e-c591e1926f07 0472-0404 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate LOTION TOPICAL 20120103 ANDA ANDA078223 Actavis Mid Atlantic LLC CLOBETASOL PROPIONATE .05 g/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0472-0527_1a9879a9-58b0-4efa-a3d0-7cffa6783bf8 0472-0527 HUMAN OTC DRUG Childrens Allergy Fexofenadine Hydrochloride Fexofenadine Hydrochloride SUSPENSION ORAL 20141222 ANDA ANDA203330 Actavis Pharma, Inc. FEXOFENADINE HYDROCHLORIDE 30 mg/5mL 0472-0730_bc8e696e-eaa4-453f-8d15-98c4cef76475 0472-0730 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20110916 ANDA ANDA074164 Actavis Mid Atlantic LLC MICONAZOLE NITRATE 2 g/100g 0472-0735_c56731a4-97b0-4f2c-9dd8-4da6dfb7e901 0472-0735 HUMAN OTC DRUG Antifungal miconazole nitrate CREAM TOPICAL 20070501 OTC MONOGRAPH FINAL part333C Actavis Mid Atlantic LLC MICONAZOLE NITRATE 20 mg/g 0472-0803_6854c529-91fc-4aed-8ad9-8ff032ac5983 0472-0803 HUMAN PRESCRIPTION DRUG DESONIDE DESONIDE LOTION TOPICAL 20090528 ANDA ANDA072354 Actavis Mid Atlantic LLC, Lincolnton, NC 28092 DESONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0472-0804_e2634f92-7e5a-4840-be47-7e32e0a3d60f 0472-0804 HUMAN PRESCRIPTION DRUG Desonide Desonide CREAM TOPICAL 20130801 NDA AUTHORIZED GENERIC NDA019048 Actavis Mid Atlantic LLC DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0472-0829_dd01fd90-413a-4e72-9c88-e858d90f0775 0472-0829 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide SOLUTION TOPICAL 20130722 ANDA ANDA071535 Actavis Mid Atlantic LLC FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0472-0882_e8843406-2806-4f9f-83d1-c35999d8ae45 0472-0882 HUMAN PRESCRIPTION DRUG Acetasol HC Hydorcortisone and Acetic Acid SOLUTION AURICULAR (OTIC) 20020910 ANDA ANDA087143 Actavis Mid Atlantic LLC ACETIC ACID; HYDROCORTISONE 2.41; 1.1 g/100mL; g/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0472-0911_5f6014f9-4a54-47c6-a290-01472e6c0fe7 0472-0911 HUMAN PRESCRIPTION DRUG Metronidazole Topical Cream, 0.75% Metronidazole Topical Cream, 0.75% CREAM TOPICAL 20090618 NDA NDA020531 Actavis Mid Atlantic LLC, Lincolnton, NC 28092 METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0472-0912_e1c188fa-7755-4650-a6ab-f696a41766b3 0472-0912 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE LOTION TOPICAL 20090528 NDA NDA020901 Actavis Mid Atlantic LLC, METRONIDAZOLE 7.5 mg/mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0472-1030_6ea55b8d-8e84-464a-bb4c-8c3b49f40e26 0472-1030 HUMAN PRESCRIPTION DRUG Hydromet hydrocodone bitartrate and homatropine methylbromide SYRUP ORAL 20020930 ANDA ANDA088017 Actavis Mid Atlantic LLC HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5; 5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0472-1105_51796454-d0f5-4745-96ea-85d23eabd7ab 0472-1105 HUMAN OTC DRUG Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 20020301 OTC MONOGRAPH FINAL part333B Actavis Pharma, Inc. BACITRACIN ZINC 500 [USP&apos'U]/g 0472-1200_107ec71c-fe08-4ea0-92a7-244b5386b353 0472-1200 HUMAN OTC DRUG FeverALL Infants acetaminophen SUPPOSITORY RECTAL 19800401 NDA NDA018337 Actavis Mid Atlantic LLC ACETAMINOPHEN 80 mg/1 0472-1201_0ed6eb34-ecf3-410e-8bed-1e8def9aff6a 0472-1201 HUMAN OTC DRUG FeverALL Children acetaminophen SUPPOSITORY RECTAL 19800401 NDA NDA018337 Actavis Mid Atlantic LLC ACETAMINOPHEN 120 mg/1 0472-1202_6c35e0be-0e9e-4315-991c-353a41bde71a 0472-1202 HUMAN OTC DRUG FeverALL Junior acetaminophen SUPPOSITORY RECTAL 19800401 NDA NDA018337 Actavis Mid Atlantic LLC ACETAMINOPHEN 325 mg/1 0472-1203_6ba5d432-2db2-47f4-a549-751aa562da09 0472-1203 HUMAN OTC DRUG FeverALL Adults acetaminophen SUPPOSITORY RECTAL 19800401 NDA NDA018337 Actavis Mid Atlantic LLC ACETAMINOPHEN 650 mg/1 0472-1255_cac0b4dc-82b2-4057-9a05-3d2c9b1f59ce 0472-1255 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Actavis Mid Atlantic LLC IBUPROFEN 100 mg/5mL 0472-1261_cac0b4dc-82b2-4057-9a05-3d2c9b1f59ce 0472-1261 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Actavis Mid Atlantic LLC IBUPROFEN 100 mg/5mL 0472-1262_cac0b4dc-82b2-4057-9a05-3d2c9b1f59ce 0472-1262 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Actavis Mid Atlantic LLC IBUPROFEN 100 mg/5mL 0472-1263_cac0b4dc-82b2-4057-9a05-3d2c9b1f59ce 0472-1263 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Actavis Mid Atlantic LLC IBUPROFEN 100 mg/5mL 0472-1270_1dc0109f-8b89-4d2f-95cc-09e4540cebe8 0472-1270 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20020927 ANDA ANDA074978 Actavis Mid Atlantic LLC IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0472-1326_af026b48-2834-4cf8-8360-8da90e184940 0472-1326 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 20030103 ANDA ANDA087796 Actavis Mid Atlantic LLC HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0472-1400_1f18da82-08a9-408e-9ffa-7808b996cffc 0472-1400 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride SYRUP ORAL 20090731 ANDA ANDA040668 Actavis Mid Atlantic LLC CYPROHEPTADINE HYDROCHLORIDE 2 mg/5mL 0472-1627_9943840e-05c9-44da-8f75-a5520fc6c5d2 0472-1627 HUMAN PRESCRIPTION DRUG Prometh with Codeine promethazine hydrochloride and codeine phosphate SYRUP ORAL 20030103 ANDA ANDA088763 Actavis Mid Atlantic LLC CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 0472-1628_29d42c05-aff6-45ed-bc26-014e56345a51 0472-1628 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride and phenylephrine hydrochloride Promethazine hydrochloride and phenylephrine hydrochloride SYRUP ORAL 20111219 ANDA ANDA088761 Actavis Mid Atlantic LLC PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 5; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 0472-1629_b0838177-aa10-455d-b969-58967f932f9e 0472-1629 HUMAN PRESCRIPTION DRUG PROMETHAZINE VC WITH CODEINE PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP ORAL 20111219 ANDA ANDA088764 Actavis Mid Atlantic LLC CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10; 5; 6.25 mg/5mL; mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 0472-1630_30d54796-9513-4a40-8710-929fc64801f8 0472-1630 HUMAN PRESCRIPTION DRUG Prometh with Dextromethorphan Promethazine Hydrochloride, Dextromethorphan Hydrobromide SYRUP ORAL 20070103 ANDA ANDA088762 Actavis Mid Atlantic LLC DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] 0472-1736_4dc31658-f5c0-4274-ac6e-e0ef2ec991f7 0472-1736 HUMAN OTC DRUG Miconazole 7 miconazole nitrate SUPPOSITORY VAGINAL 19931119 ANDA ANDA073507 Actavis Mid Atlantic LLC MICONAZOLE NITRATE 100 mg/1 0472-1738_009711be-7906-4bed-9755-2017a7b7f869 0472-1738 HUMAN PRESCRIPTION DRUG Miconazole Nitrate Miconazole Nitrate SUPPOSITORY VAGINAL 20020903 ANDA ANDA073508 Actavis Mid Atlantic LLC MICONAZOLE NITRATE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0472-3901_9c0e60d3-58c4-254f-9f04-0cec80c222ce 0472-3901 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20140409 ANDA ANDA073085 Actavis Mid Atlantic LLC FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0472-5002_6ca65822-32d2-4d3b-8ec6-670f968d0869 0472-5002 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20090302 ANDA ANDA089892 Actavis Mid Atlantic LLC PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0472-5242_2028c8aa-8562-44e4-978d-9c8a9dba7c0c 0472-5242 HUMAN OTC DRUG Lice Treatment permethrin LOTION TOPICAL 20100328 ANDA ANDA075014 Actavis Mid Atlantic LLC PERMETHRIN 1 mg/100mL 0482-0061_149d2a65-42ed-4eb8-b5cb-80a61b191773 0482-0061 HUMAN PRESCRIPTION DRUG Pamine methscopolamine bromide TABLET ORAL 19530409 NDA NDA008848 PharmaDerm A division of Fougera Pharmaceuticals Inc. METHSCOPOLAMINE BROMIDE 2.5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0482-0062_149d2a65-42ed-4eb8-b5cb-80a61b191773 0482-0062 HUMAN PRESCRIPTION DRUG Pamine Forte methscopolamine bromide TABLET ORAL 20030325 NDA NDA008848 PharmaDerm A division of Fougera Pharmaceuticals Inc. METHSCOPOLAMINE BROMIDE 5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0485-0051_9431983a-58df-4d8c-91f5-6843811c4537 0485-0051 HUMAN PRESCRIPTION DRUG UROGESIC BLUE METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, and HYOSCYAMINE SULFATE TABLET ORAL 20100430 UNAPPROVED DRUG OTHER EDWARDS PHARMACEUTICAL, INC. HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; SODIUM PHOSPHATE, MONOBASIC .12; 81.6; 10.8; 40.8 mg/1; mg/1; mg/1; mg/1 0485-0057_9d2f2fbf-0dd3-414f-9747-23dd7e7a7408 0485-0057 HUMAN OTC DRUG ED APAP ACETAMINOPHEN LIQUID ORAL 20120307 OTC MONOGRAPH NOT FINAL part343 EDWARDS PHARMACEUTICALS, INC. ACETAMINOPHEN 160 mg/5mL 0485-0080_5649f4a1-21c1-469f-9406-28a843596476 0485-0080 HUMAN OTC DRUG RYMED DEXCHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20111115 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. DEXCHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 2; 10 mg/1; mg/1 0485-0082_f9932dae-2767-4e93-997e-bf37078e0dca 0485-0082 HUMAN PRESCRIPTION DRUG ED-SPAZ HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING ORAL 20100512 UNAPPROVED DRUG OTHER EDWARDS PHARMACEUTICALS, INC. HYOSCYAMINE SULFATE .125 mg/1 0485-0085_f2be72e4-5a4d-4a41-ac78-dd9f683bdf9d 0485-0085 HUMAN OTC DRUG ED-CHLORTAN CHLORPHENIRAMINE MALEATE TABLET, COATED ORAL 20110607 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. CHLORPHENIRAMINE MALEATE 4 mg/1 0485-0094_f10138b7-8948-4e8d-9d83-5eb2ec52fd93 0485-0094 HUMAN OTC DRUG ED CHLORPED CHLORPHENIRAMINE MALEATE LIQUID ORAL 20110428 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. CHLORPHENIRAMINE MALEATE 2 mL/mL 0485-0096_be992722-c10f-4c64-9eb0-4c6ab9cb33e6 0485-0096 HUMAN OTC DRUG ED CHLORPED D CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20110601 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 2; 5 mg/mL; mg/mL 0485-0098_8d20e21a-3e3c-4bc5-90b8-bb1e724bd511 0485-0098 HUMAN OTC DRUG ED CHLORPED JR CHLORPHENIRAMINE MALEATE LIQUID ORAL 20110304 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. CHLORPHENIRAMINE MALEATE 2 mg/5mL 0485-0151_10109075-6a32-4562-9dc8-c148a61d5d58 0485-0151 HUMAN PRESCRIPTION DRUG UROGESIC BLUE METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, and HYOSCYAMINE SULFATE TABLET, COATED ORAL 20101119 UNAPPROVED DRUG OTHER EDWARDS PHARMACEUTICALS, INC. HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; SODIUM PHOSPHATE, MONOBASIC .12; 81.6; 10.8; 40.8 mg/1; mg/1; mg/1; mg/1 0485-0155_302e2918-16aa-45a1-b87b-2feda0e0297d 0485-0155 HUMAN OTC DRUG ED A-HIST Chlorpheniramine/Phenylephrine LIQUID ORAL 20110111 OTC MONOGRAPH FINAL part341 Edwards Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/5mL; mg/5mL 0485-0171_1a30fe48-2898-4051-9341-93170a267371 0485-0171 HUMAN OTC DRUG ED A-HIST DM DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20120911 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 15; 10 mg/5mL; mg/5mL; mg/5mL 0485-0202_02e9a349-1fc1-4121-a8ea-4b0f8ef8dc78 0485-0202 HUMAN OTC DRUG RYNEX PE BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20110307 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 15 mg/5mL; mg/5mL 0485-0204_79c80aff-7646-4363-91c5-6c89d6daaefd 0485-0204 HUMAN OTC DRUG Rynex DM Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20110314 OTC MONOGRAPH FINAL part341 Edwards Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 0485-0206_7a2f6dd4-7d1d-4058-a2f0-126327eb557f 0485-0206 HUMAN OTC DRUG RYNEX PSE BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20110307 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 15 mg/5mL; mg/5mL 0485-0208_fea45bff-6e84-492c-b9f0-eae03248536f 0485-0208 HUMAN OTC DRUG ED BRON GP GUAIFENESIN and PHENYLEPHRINE LIQUID ORAL 20120601 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. GUAIFENESIN; PHENYLEPHRINE 100; 5 mg/5mL; mg/5mL 0485-0210_5a2b4ef1-6705-433d-aeb3-6ddd1c204d9c 0485-0210 HUMAN OTC DRUG ED-A-HIST PSE PSEUDOEPHEDRINE HYDROCHLORIDE and TRIPROLIDINE HYDROCHLORIDE TABLET, COATED ORAL 20111008 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 60; 2.5 mg/1; mg/1 0485-0240_0b56f57d-6a1b-4c9a-b28b-0fca8064c739 0485-0240 HUMAN OTC DRUG ED-A-HIST DM CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141027 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 10; 10 mg/1; mg/1; mg/1 0485-0250_4ce30989-449b-44d3-a204-b4a24165fd77 0485-0250 HUMAN OTC DRUG MucaphEd GUAIFENESIN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20120911 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 0485-0254_f2ad5fe9-9dfc-4cfa-8504-9ecfa39c0ad2 0485-0254 HUMAN OTC DRUG ED A-HIST CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20111008 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 0486-1111_1c2ceda2-0bfa-4637-bb0c-1df7609be153 0486-1111 HUMAN PRESCRIPTION DRUG K Phos Original Potassium Phosphate, Monobasic TABLET, SOLUBLE ORAL 19770329 UNAPPROVED DRUG OTHER Beach Products, Inc. POTASSIUM PHOSPHATE, MONOBASIC 500 mg/1 0486-1125_e7ead2c5-afb2-4d45-a4e9-71ba4c25752b 0486-1125 HUMAN PRESCRIPTION DRUG K Phos Neutral Sodium Phosphate, Dibasic, Anhydrous, Potassium Phosphate, Monobasic, and Sodium Phosphate, Monobasic, Monohydrate TABLET, COATED ORAL 19770411 UNAPPROVED DRUG OTHER Beach Productsd, Inc. POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 155; 852; 130 mg/1; mg/1; mg/1 0486-1134_b359f863-2f6e-4884-8714-e34585df1fa1 0486-1134 HUMAN PRESCRIPTION DRUG K-Phos No. 2 Potassium Phosphate, Monobasic and Sodium Phosphate, Monobasic, Anhydrous TABLET, COATED ORAL 19780509 UNAPPROVED DRUG OTHER Beach Products, Inc. POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS 305; 700 mg/1; mg/1 0487-0201_b5387e98-fa4a-4c1e-a415-b841f29ec79d 0487-0201 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20071231 ANDA ANDA076749 Nephron Pharmaceuticals Corporation ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 3; .5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0487-0301_f269bd00-7c57-4c03-b5ab-77eb0d9d2d34 0487-0301 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20100331 ANDA ANDA076355 Nephron Pharmaceuticals Corporation ALBUTEROL SULFATE .75 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0487-2784_0a0850b4-5026-73ce-e054-00144ff8d46c 0487-2784 HUMAN OTC DRUG Asthmanefrin racepinephrine hydrochloride SOLUTION RESPIRATORY (INHALATION) 20120801 OTC MONOGRAPH FINAL part341 Nephron Pharmaceuticals Corporation RACEPINEPHRINE HYDROCHLORIDE 11.25 mg/.5mL 0487-5901_bd52f7c0-56c7-4f4c-8231-148d2854be18 0487-5901 HUMAN OTC DRUG S2 racepinephrine hydrochloride SOLUTION RESPIRATORY (INHALATION) 20000101 OTC MONOGRAPH FINAL part341 Nephron Pharmaceuticals Corporation RACEPINEPHRINE HYDROCHLORIDE 11.25 mg/.5mL 0487-9301_00451b25-f4c3-4c61-a8ce-bee22074a3bd 0487-9301 HUMAN OTC DRUG Sodium Chloride ISodium Chloride SOLUTION RESPIRATORY (INHALATION) 20020718 UNAPPROVED DRUG OTHER Nephron Pharmaceuticals Corporation SODIUM CHLORIDE .027 mg/3mL 0487-9501_b4952a08-d2d8-43f4-8d41-a68f4bbdf8c3 0487-9501 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19970917 ANDA ANDA074880 Nephron Pharmaceuticals Corporation ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0487-9601_04d3d3d9-88f4-48fa-923e-ada92f73bef9 0487-9601 HUMAN PRESCRIPTION DRUG Budesonide BUDESONIDE INHALANT RESPIRATORY (INHALATION) 20131001 ANDA ANDA078202 Nephron Pharmaceuticals Corporation BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0487-9701_04d3d3d9-88f4-48fa-923e-ada92f73bef9 0487-9701 HUMAN PRESCRIPTION DRUG Budesonide BUDESONIDE INHALANT RESPIRATORY (INHALATION) 20131001 ANDA ANDA078202 Nephron Pharmaceuticals Corporation BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0487-9801_97e130d5-02ce-4acb-b2bc-71877751a29c 0487-9801 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20010927 ANDA ANDA075562 Nephron Pharmaceuticals Corporation IPRATROPIUM BROMIDE .5 mg/2.5mL 0487-9901_b88244c6-ab54-42b3-8be3-f7c80a773973 0487-9901 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20010626 ANDA ANDA075664 Nephron Pharmaceuticals Corporation ALBUTEROL SULFATE 2.5 mg/.5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0487-9904_f269bd00-7c57-4c03-b5ab-77eb0d9d2d34 0487-9904 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20040628 ANDA ANDA076355 Nephron Pharmaceuticals Corporation ALBUTEROL SULFATE 1.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0496-0708_b2636cac-b45f-4cc6-972b-d55535fc2762 0496-0708 HUMAN PRESCRIPTION DRUG Pramosone E hydrocortisone acetate and pramoxine hydrochloride CREAM TOPICAL 20100205 UNAPPROVED DRUG OTHER Ferndale Laboratories, Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 25; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0496-0716_85fc5ff7-1041-4b6a-b907-bb2084415ffe 0496-0716 HUMAN PRESCRIPTION DRUG Pramosone hydrocortisone acetate and pramoxine hydrochloride CREAM TOPICAL 19770131 ANDA ANDA085368 Ferndale Laboratories, Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 10; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0496-0726_9ac50ae9-fce2-45ee-96b9-177b60efd242 0496-0726 HUMAN PRESCRIPTION DRUG Pramosone hydrocortisone acetate and pramoxine hydrochloride LOTION TOPICAL 19770730 ANDA ANDA085979 Ferndale Laboratories, Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 25; 10 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0496-0729_89ba5f84-72c5-458a-837f-ffb9c53628d8 0496-0729 HUMAN PRESCRIPTION DRUG Pramosone hydrocortisone acetate and pramoxine hydrochloride LOTION TOPICAL 19770101 ANDA ANDA085980 Ferndale Laboratories, Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 10; 10 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0496-0730_1b5dcea6-d614-4d3f-85ca-c7cd45007566 0496-0730 HUMAN PRESCRIPTION DRUG Analpram Advanced hydrocortisone acetate and pramoxine hydrochloride KIT 20101001 UNAPPROVED DRUG OTHER Ferndale Laboratories, Inc. 0496-0731_1b5dcea6-d614-4d3f-85ca-c7cd45007566 0496-0731 HUMAN PRESCRIPTION DRUG Analpram Advanced hydrocortisone acetate and pramoxine hydrochloride KIT 20101001 UNAPPROVED DRUG OTHER Ferndale Laboratories, Inc. 0496-0732_1b5dcea6-d614-4d3f-85ca-c7cd45007566 0496-0732 HUMAN PRESCRIPTION DRUG Analpram Advanced hydrocortisone acetate and pramoxine hydrochloride KIT 20100801 UNAPPROVED DRUG OTHER Ferndale Laboratories, Inc. 0496-0748_2aa37fc5-2b08-4c13-b473-30d7ffe92fc1 0496-0748 HUMAN OTC DRUG PRAX pramoxine hydrochloride LOTION TOPICAL 20120401 OTC MONOGRAPH FINAL part346 Ferndale Laboratories, Inc. PRAMOXINE HYDROCHLORIDE 10 mg/mL 0496-0749_03b1fe7f-347b-4892-9a1d-127dad23f1dc 0496-0749 HUMAN OTC DRUG Prax Wipe pramoxine hydrochloride 1% SWAB TOPICAL 20090801 OTC MONOGRAPH FINAL part346 Ferndale Laboratories, Inc. PRAMOXINE HYDROCHLORIDE 10 mg/g 0496-0750_3e9168cf-6e95-42d6-b362-0b363b32b8e7 0496-0750 HUMAN PRESCRIPTION DRUG Analpram E Hydrocortisone Acetate and Pramoxine Hydrochloride KIT 20090901 UNAPPROVED OTHER Ferndale Laboratories, Inc. 0496-0751_3e9168cf-6e95-42d6-b362-0b363b32b8e7 0496-0751 HUMAN PRESCRIPTION DRUG Analpram E hydrocortisone acetate and pramoxine hydrochloride KIT 20090901 UNAPPROVED OTHER Ferndale Laboratories, Inc. 0496-0752_3e9168cf-6e95-42d6-b362-0b363b32b8e7 0496-0752 HUMAN PRESCRIPTION DRUG Analpram E hydrocortisone acetate and pramoxine hydrochloride KIT 20090901 UNAPPROVED OTHER Ferndale Laboratories, Inc. 0496-0755_5fb56dee-d3af-4f8d-ace1-625209b23dad 0496-0755 HUMAN PRESCRIPTION DRUG Analpram E hydrocortisone acetate and pramoxine hydrochloride CREAM TOPICAL 20090630 UNAPPROVED DRUG OTHER Ferndale Laboratories, Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 25; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0496-0760_c4acd470-427b-4e1d-b232-a68da4d6b965 0496-0760 HUMAN PRESCRIPTION DRUG Pramosone hydrocortisone acetate and pramoxine hydrochloride CREAM TOPICAL 20100208 UNAPPROVED DRUG OTHER Ferndale Laboratories, Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 25; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0496-0763_70a22e2c-f4ee-42b7-9db5-3af9681f4280 0496-0763 HUMAN PRESCRIPTION DRUG PRAMOSONE hydrocortisone acetate and pramoxine hydrochloride OINTMENT TOPICAL 19890721 UNAPPROVED DRUG OTHER Ferndale Laboratories, Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 10; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0496-0777_4dabbcb1-a0a7-4d2b-9e0a-9b3b98cb4285 0496-0777 HUMAN PRESCRIPTION DRUG PRAMOSONE hydrocortisone acetate and pramoxine hydrochloride OINTMENT TOPICAL 19890721 UNAPPROVED DRUG OTHER Ferndale Laboratories, Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 25; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0496-0778_67887c7c-ca54-4cf4-8833-32ab50d7b4e2 0496-0778 HUMAN PRESCRIPTION DRUG Analpram HC hydrocortisone acetate and pramoxine hydrochloride CREAM TOPICAL 19851223 ANDA ANDA085368 Ferndale Laboratories, Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 10; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0496-0799_360a5f87-6ac1-4e10-92ad-c6c826d91dd2 0496-0799 HUMAN PRESCRIPTION DRUG Analpram HC hydrocortisone acetate and pramoxine hydrochloride CREAM TOPICAL 20091015 UNAPPROVED DRUG OTHER Ferndale Laboratories, Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 25; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0496-0829_a1291c7f-82b6-4672-a824-bb0b4f043c09 0496-0829 HUMAN PRESCRIPTION DRUG Analpram HC hydrocortisone acetate and pramoxine hydrochloride LOTION TOPICAL 19960101 ANDA ANDA085979 Ferndale Laboratories, Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 25; 10 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0496-0882_3a0301c3-5f27-4d51-a75b-57fa969f35cf 0496-0882 HUMAN OTC DRUG LMX4 lidocaine CREAM TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part348 Ferndale Laboratories, Inc. LIDOCAINE 40 mg/g 0496-0883_4ecf1dbb-8a0f-462b-b50f-767fe1f5ad66 0496-0883 HUMAN OTC DRUG LMX5 lidocaine CREAM TOPICAL 20031001 OTC MONOGRAPH FINAL part346 Ferndale Laboratories, Inc. LIDOCAINE 50 mg/g 0496-0892_fb072ae5-d55e-4186-b198-cf0a4e9d0b6c 0496-0892 HUMAN OTC DRUG RECTICARE lidocaine CREAM TOPICAL 20120309 OTC MONOGRAPH FINAL part346 Ferndale Laboratories, Inc. LIDOCAINE 50 mg/g 0496-0973_c1739b9d-8680-4f5a-9686-00ba2c7b2ef2 0496-0973 HUMAN OTC DRUG OC8 benzoyl peroxide GEL TOPICAL 20120813 OTC MONOGRAPH NOT FINAL part333D Ferndale Laboratories, Inc. BENZOYL PEROXIDE 7 mg/g 0498-0010_42252bad-05ea-40fe-89c1-66d9aad8ef64 0498-0010 HUMAN OTC DRUG Pyrocaine Burn Benzocaine, Benzethonium Chloride AEROSOL, SPRAY TOPICAL 20130320 OTC MONOGRAPH NOT FINAL part348 North Safety Products BENZETHONIUM CHLORIDE; BENZOCAINE .2; 20 g/100g; g/100g 0498-0015_4a402e6c-8fae-479e-962f-6a4922fa2a81 0498-0015 HUMAN OTC DRUG North First Aid Antiseptic Benzalkonium Chloride, Benzocaine SPRAY TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part348 North Safety Products BENZETHONIUM CHLORIDE; BENZOCAINE .2; 10 g/100g; g/100g 0498-0016_b73cf3ac-a97a-4cae-b0c5-d84687a8c604 0498-0016 HUMAN OTC DRUG NORTH Antiseptic First Aid benzalkonium chloride and lidocaine SPRAY, METERED TOPICAL 20140429 OTC MONOGRAPH NOT FINAL part348 North Safety Products, LLC. BENZALKONIUM CHLORIDE; LIDOCAINE 107.1; 1912.5 mg/90mL; mg/90mL 0498-0020_c2d671d6-ab13-4025-8112-3655ec30f15a 0498-0020 HUMAN OTC DRUG North Burn Benzocaine, Benzethonium chloride, Menthol SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 North Safety Products BENZETHONIUM CHLORIDE; BENZOCAINE; MENTHOL .2; 10; .33 g/100g; g/100g; g/100g 0498-0097_394ccab2-8ddf-4248-adda-97a3c676b16d 0498-0097 HUMAN OTC DRUG North Antihistamine DIPHENHYDRAMINE TABLET ORAL 20111202 OTC MONOGRAPH FINAL part341 North Safety Products DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0498-0113_8013b08a-9199-45b7-8046-1bc2c2b29d99 0498-0113 HUMAN OTC DRUG North Aspirin Aspirin TABLET ORAL 20111107 OTC MONOGRAPH FINAL part343 North Safety Products ASPIRIN 325 1/1 0498-0119_eee2f198-f019-4c85-985b-64ceedd25140 0498-0119 HUMAN OTC DRUG North Cough Drop Menthol LOZENGE ORAL 20130824 OTC MONOGRAPH FINAL part341 North Safety Products MENTHOL 7 mg/1 0498-0140_c18da62e-0dba-4749-9dd7-f0ef20568397 0498-0140 HUMAN OTC DRUG North Alcohol Wipe Isopropyl alcohol SWAB TOPICAL 20130718 OTC MONOGRAPH NOT FINAL part333A North Safety Products ISOPROPYL ALCOHOL .7 mL/mL 0498-0160_d2a4e6e3-5f80-476d-adf1-bdd94ee12dfd 0498-0160 HUMAN OTC DRUG Buffered Eye-Lert Water LIQUID OPHTHALMIC 20100606 OTC MONOGRAPH FINAL part349 North Safety Products WATER 98 mL/100mL 0498-0201_be31049f-e529-4b18-a166-cb595c6228a8 0498-0201 HUMAN OTC DRUG North Burn Relief Lidocaine Hydrochloride SPRAY TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part348 North Safety Products LIDOCAINE HYDROCHLORIDE 24.64 mg/mL 0498-0303_c7660e31-e259-4cf3-96ba-4144a00247ae 0498-0303 HUMAN OTC DRUG Miralac CALCIUM CARBONATE TABLET ORAL 20120222 OTC MONOGRAPH FINAL part331 North Safety Products CALCIUM CARBONATE 420 mg/1 0498-0304_4675358c-7472-4184-a55f-ba8702142785 0498-0304 HUMAN OTC DRUG MIRALAC ANTACID CALCIUM CARBONATE TABLET ORAL 20130222 OTC MONOGRAPH FINAL part331 North Safety Products CALCIUM CARBONATE 420 mg/1 0498-0401_e73f07be-3ca0-40b7-8f8f-2f11fd37d1b1 0498-0401 HUMAN OTC DRUG North Antiseptic Benzalkonium chloride SPRAY TOPICAL 20130224 OTC MONOGRAPH NOT FINAL part333E North Safety Products BENZALKONIUM CHLORIDE .13 g/100mL 0498-0740_02c54eb8-05f5-47e7-8982-5eced854fa35 0498-0740 HUMAN OTC DRUG North Triple Antibiotic Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate OINTMENT TOPICAL 20130307 OTC MONOGRAPH FINAL part333B North Safety Products BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 0498-0800_f4076d5e-97d0-4823-b190-8039fc0dd853 0498-0800 HUMAN OTC DRUG HYDROCORTISONE Anti-itch cream OINTMENT TOPICAL 20130306 OTC MONOGRAPH NOT FINAL part348 North Safety Products HYDROCORTISONE ACETATE 1 g/100g 0498-1040_7f9608a0-a288-4883-b3aa-075e99f13b53 0498-1040 HUMAN OTC DRUG Swift Sinus Pain Acetaminophen, Phenylephrine HCl TABLET ORAL 20110414 OTC MONOGRAPH FINAL part341 North Safety Products LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 0498-1070_85130c99-0914-4414-8d8d-ec67add21f31 0498-1070 HUMAN OTC DRUG Multi Symptom Cold Acetaminophen, Dextromethorphan, Phenylephrine, Guaifenesin TABLET ORAL 20120424 OTC MONOGRAPH FINAL part343 North Safety Products LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 162 mg/1; mg/1; mg/1; mg/1 0498-1071_9732d758-679f-43df-848e-d3dd0a617fbb 0498-1071 HUMAN OTC DRUG Antidiarrheal Relief Loperamide HCl TABLET ORAL 20130429 ANDA ANDA074091 North Safety Products LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 0498-2000_843409f9-bf46-497d-a940-ee500bbef8e7 0498-2000 HUMAN OTC DRUG Aypanal Acetaminophen TABLET ORAL 20120410 OTC MONOGRAPH NOT FINAL part343 North Safety Products ACETAMINOPHEN 325 mg/1 0498-2100_9227976c-3bab-41c1-8cd9-b83b65a23f63 0498-2100 HUMAN OTC DRUG Swift Aypanal Extra Acetaminophen TABLET ORAL 20110414 OTC MONOGRAPH NOT FINAL part343 North Safety Products ACETAMINOPHEN 500 mg/1 0498-2101_c793d260-5cfc-4ad7-aeb7-8c9d825c3286 0498-2101 HUMAN OTC DRUG BACK RELIEF ACETAMINOPHEN, MAGNESIUM SALICYLATE TABLET ORAL 20130514 OTC MONOGRAPH NOT FINAL part343 North Safety Products LLC ACETAMINOPHEN; MAGNESIUM SALICYLATE 200; 200 mg/1; mg/1 0498-2420_85ad5069-a70b-4ccf-b417-f7e8cff8c9ce 0498-2420 HUMAN OTC DRUG Pain Stopper Extra Acetaminophen, Caffeine, Aspirin, Salicylamide TABLET ORAL 20120307 OTC MONOGRAPH NOT FINAL part343 North Safety Products LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE; SALICYLAMIDE 110; 162; 32.4; 152 mg/1; mg/1; mg/1; mg/1 0498-2421_6fcff191-5999-4a37-a8d3-cdb42d147c00 0498-2421 HUMAN OTC DRUG Pain Stoppers Regular Acetaminophen, Caffeine, Aspirin, Salicylamide TABLET ORAL 20130418 OTC MONOGRAPH NOT FINAL part343 North Safety Products LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE; SALICYLAMIDE 110; 162; 32.4; 152 mg/1; mg/1; mg/1; mg/1 0498-2520_618afe2e-b747-4ea2-9569-1be531c70b7d 0498-2520 HUMAN OTC DRUG Pain Stoppers Extra Acetaminophen, Caffeine, Aspirin TABLET, COATED ORAL 20120307 OTC MONOGRAPH NOT FINAL part343 North Safety Products LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0498-3330_1e8c7e34-7afb-4ff6-b10d-95c2cd9aeca2 0498-3330 HUMAN OTC DRUG North Sinus Decongestant Phenylephrine TABLET ORAL 20120610 OTC MONOGRAPH FINAL part341 North Safety Products PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 0498-7000_46ccf11f-244a-411d-ab4e-0a5d350d24cd 0498-7000 HUMAN OTC DRUG Fem Relief Acetaminophen Pamabrom TABLET ORAL 20120215 OTC MONOGRAPH NOT FINAL part343 North Safety Products LLC ACETAMINOPHEN; PAMABROM 325; 25 mg/1; mg/1 0498-7500_712fe745-57d3-43a9-865f-57f7145870ae 0498-7500 HUMAN OTC DRUG Cedaprin Ibuprofen TABLET ORAL 20120307 ANDA ANDA079129 North Safety Products LLC IBUPROFEN 200 mg/1 0517-0020_bb01c86c-66ad-45d8-9f01-a84fb9b4ff14 0517-0020 HUMAN PRESCRIPTION DRUG Caffeine Citrate Caffeine Citrate INJECTION, SOLUTION INTRAVENOUS 20070910 ANDA ANDA077906 American Regent, Inc. CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0517-0031_05386eaa-75b6-44a2-afb6-4fe04e38e67a 0517-0031 HUMAN PRESCRIPTION DRUG Cyanocobalamin cyanocobalamin INJECTION, SOLUTION INTRAMUSCULAR 19900930 ANDA ANDA080737 American Regent, Inc. CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 0517-0032_05386eaa-75b6-44a2-afb6-4fe04e38e67a 0517-0032 HUMAN PRESCRIPTION DRUG Cyanocobalamin cyanocobalamin INJECTION, SOLUTION INTRAMUSCULAR 19961107 ANDA ANDA080737 American Regent, Inc. CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 0517-0033_1f217626-9718-467b-8062-00a0064ec150 0517-0033 HUMAN PRESCRIPTION DRUG Neostigmine Methylsulfate Neostigmine Methylsulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20030116 UNAPPROVED DRUG OTHER American Regent, Inc. NEOSTIGMINE METHYLSULFATE 1 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0517-0034_1f217626-9718-467b-8062-00a0064ec150 0517-0034 HUMAN PRESCRIPTION DRUG Neostigmine Methylsulfate Neostigmine Methylsulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20030117 UNAPPROVED DRUG OTHER American Regent, Inc. NEOSTIGMINE METHYLSULFATE .5 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0517-0101_d51a918e-bba6-48ca-8461-76e61324b7e8 0517-0101 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19921101 UNAPPROVED DRUG OTHER American Regent, Inc. ATROPINE SULFATE 1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0517-0130_05386eaa-75b6-44a2-afb6-4fe04e38e67a 0517-0130 HUMAN PRESCRIPTION DRUG Cyanocobalamin cyanocobalamin INJECTION, SOLUTION INTRAMUSCULAR 20030529 ANDA ANDA080737 American Regent, Inc. CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 0517-0131_02298ea1-b461-4bc9-b426-488d059ed3ea 0517-0131 HUMAN PRESCRIPTION DRUG Dexpanthenol Dexpanthenol INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19930820 UNAPPROVED DRUG OTHER American Regent, Inc. DEXPANTHENOL 250 mg/mL 0517-0132_19b4ee40-b258-4129-a4b9-4cffdadccbd4 0517-0132 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol INJECTION, SOLUTION INTRAVENOUS 20050314 ANDA ANDA075746 American Regent, Inc. CALCITRIOL 1 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 0517-0134_af01fdb8-d3d7-4186-a58f-f58839f1ceb8 0517-0134 HUMAN PRESCRIPTION DRUG Dexferrum iron dextran INJECTION, SOLUTION INTRAVENOUS 19981001 NDA NDA040024 American Regent, Inc. IRON DEXTRAN 50 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 0517-0234_af01fdb8-d3d7-4186-a58f-f58839f1ceb8 0517-0234 HUMAN PRESCRIPTION DRUG Dexferrum iron dextran INJECTION, SOLUTION INTRAVENOUS 19960301 NDA NDA040024 American Regent, Inc. IRON DEXTRAN 50 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 0517-0299_6c506d53-fae5-4405-9170-343f6f95f387 0517-0299 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 0517-0301_e8ae0b66-25de-41b1-8013-7f414bbb7568 0517-0301 HUMAN PRESCRIPTION DRUG Methylene Blue Methylene Blue INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. METHYLENE BLUE 10 mg/mL 0517-0310_e8ae0b66-25de-41b1-8013-7f414bbb7568 0517-0310 HUMAN PRESCRIPTION DRUG Methylene Blue Methylene Blue INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. METHYLENE BLUE 10 mg/mL 0517-0372_e8ae0b66-25de-41b1-8013-7f414bbb7568 0517-0372 HUMAN PRESCRIPTION DRUG Methylene Blue Methylene Blue INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. METHYLENE BLUE 10 mg/mL 0517-0373_e8ae0b66-25de-41b1-8013-7f414bbb7568 0517-0373 HUMAN PRESCRIPTION DRUG Methylene Blue Methylene Blue INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. METHYLENE BLUE 10 mg/mL 0517-0375_0aade973-199f-44a5-92fd-43afc75dbbdb 0517-0375 HUMAN PRESCRIPTION DRUG Indigo Carmine Indigo Carmine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. INDIGOTINDISULFONATE SODIUM 8 mg/mL 0517-0401_d51a918e-bba6-48ca-8461-76e61324b7e8 0517-0401 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19921101 UNAPPROVED DRUG OTHER American Regent, Inc. ATROPINE SULFATE .4 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0517-0405_6c506d53-fae5-4405-9170-343f6f95f387 0517-0405 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 0517-0410_ac576c13-8cb6-4b1d-83fb-05d2c8a439e9 0517-0410 HUMAN PRESCRIPTION DRUG Vasopressin Vasopressin INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 19960815 UNAPPROVED DRUG OTHER American Regent, Inc. ARGIPRESSIN 20 [USP'U]/mL 0517-0510_ac576c13-8cb6-4b1d-83fb-05d2c8a439e9 0517-0510 HUMAN PRESCRIPTION DRUG Vasopressin Vasopressin INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 19921001 UNAPPROVED DRUG OTHER American Regent, Inc. ARGIPRESSIN 20 [USP'U]/mL 0517-0650_08a40e1f-f305-49fb-a702-43438323701a 0517-0650 HUMAN PRESCRIPTION DRUG Injectafer Ferric Carboxymaltose Injection INJECTION, SOLUTION INTRAVENOUS 20130812 NDA NDA203565 American Regent, Inc. FERRIC CARBOXYMALTOSE 50 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 0517-0720_0aa6766d-322e-4a61-a04a-257932f50702 0517-0720 HUMAN PRESCRIPTION DRUG Betamethasone Sodium Phosphate and Betamethasone Acetate Betamethasone Sodium Phosphate and Betamethasone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR 20100428 ANDA ANDA090747 American Regent, Inc. BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE 3; 3 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0517-0725_2cb6acc4-4f84-4433-bfd1-2ffe35faf3e9 0517-0725 HUMAN PRESCRIPTION DRUG Buprenorphine Hydrochloride Buprenorphine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100813 ANDA ANDA078331 American Regent, Inc. BUPRENORPHINE HYDROCHLORIDE .324 mg/mL Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 0517-0730_bfd2cc3b-73dd-402f-acc6-c4816c00b7e8 0517-0730 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride INJECTION, SOLUTION EPIDURAL 20100415 ANDA ANDA091104 American Regent, Inc. CLONIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0517-0731_bfd2cc3b-73dd-402f-acc6-c4816c00b7e8 0517-0731 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride INJECTION, SOLUTION EPIDURAL 20100415 ANDA ANDA091104 American Regent, Inc. CLONIDINE HYDROCHLORIDE 500 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0517-0735_d0577bd6-da57-48de-895a-6af39f31dc7d 0517-0735 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20091117 ANDA ANDA090534 American Regent, Inc. NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0517-0740_08d60c14-0e2b-4fa7-81d5-75f4320704d6 0517-0740 HUMAN PRESCRIPTION DRUG Methylergonovine Maleate Methylergonovine Maleate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100621 ANDA ANDA090193 American Regent, Inc. METHYLERGONOVINE MALEATE .2 mg/mL Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 0517-0745_02bdc4b0-18cb-4806-a381-f3324eac8f86 0517-0745 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, SOLUTION INTRAVENOUS 20100716 ANDA ANDA078942 American Regent, Inc. PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0517-0746_02bdc4b0-18cb-4806-a381-f3324eac8f86 0517-0746 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, SOLUTION INTRAVENOUS 20100809 ANDA ANDA078942 American Regent, Inc. PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0517-0750_67cbd1da-38b6-498e-a721-6fb2f4528a68 0517-0750 HUMAN PRESCRIPTION DRUG Progesterone Progesterone INJECTION, SOLUTION INTRAMUSCULAR 20100929 ANDA ANDA090845 American Regent, Inc. PROGESTERONE 50 mg/mL Progesterone [Chemical/Ingredient],Progesterone [EPC] 0517-0760_e4abdf47-d651-478c-be0b-88b2f256023c 0517-0760 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20100701 ANDA ANDA076830 American Regent, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0517-0770_a6fcba37-f7d9-4d9e-bf45-c8f7af4261e3 0517-0770 HUMAN PRESCRIPTION DRUG Torsemide Torsemide INJECTION, SOLUTION INTRAVENOUS 20100521 ANDA ANDA090656 American Regent, Inc. TORSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0517-0771_a6fcba37-f7d9-4d9e-bf45-c8f7af4261e3 0517-0771 HUMAN PRESCRIPTION DRUG Torsemide Torsemide INJECTION, SOLUTION INTRAVENOUS 20100526 ANDA ANDA090656 American Regent, Inc. TORSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0517-0780_1bc50999-f23f-4d64-be7f-7ca5423e720c 0517-0780 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION, SOLUTION INTRAVENOUS 20100630 ANDA ANDA078867 American Regent, Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 0517-0781_1bc50999-f23f-4d64-be7f-7ca5423e720c 0517-0781 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION, SOLUTION INTRAVENOUS 20100630 ANDA ANDA078867 American Regent, Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 0517-0785_38afd657-1aed-43d6-aad3-9e75fc025e57 0517-0785 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110204 ANDA ANDA091152 American Regent, Inc. BENZTROPINE MESYLATE 1 mg/mL Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0517-0790_a5bf7ff6-bba0-4e86-92d1-9f929fd4794b 0517-0790 HUMAN PRESCRIPTION DRUG Nandrolone Decanoate Nandrolone Decanoate INJECTION, SOLUTION INTRAMUSCULAR 20000101 ANDA ANDA091252 American Regent, Inc. NANDROLONE DECANOATE 200 mg/mL Androgen [EPC] CIII 0517-0805_d51a918e-bba6-48ca-8461-76e61324b7e8 0517-0805 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19921101 UNAPPROVED DRUG OTHER American Regent, Inc. ATROPINE SULFATE .4 mg/.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0517-0830_d9744bf1-5b9f-40fe-a23e-e74ab4e0297c 0517-0830 HUMAN PRESCRIPTION DRUG Latanoprost Latanoprost SOLUTION OPHTHALMIC 20110802 ANDA ANDA200925 American Regent, Inc. LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 0517-0901_2e4ecf15-03d9-4e8c-9826-e5392cea3e10 0517-0901 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970630 ANDA ANDA040136 American Regent, Inc. HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 0517-0955_583f95c1-4f98-44d7-bb7f-2db827176478 0517-0955 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20120627 ANDA ANDA201741 American Regent, Inc. OLANZAPINE 10 mg/2mL Atypical Antipsychotic [EPC] 0517-0960_3940ffa8-61ff-47cf-91da-2d5afee99fe0 0517-0960 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20111115 ANDA ANDA201885 American Regent, Inc. TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 0517-1010_d51a918e-bba6-48ca-8461-76e61324b7e8 0517-1010 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19921201 UNAPPROVED DRUG OTHER American Regent, Inc. ATROPINE SULFATE 1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0517-1020_ac576c13-8cb6-4b1d-83fb-05d2c8a439e9 0517-1020 HUMAN PRESCRIPTION DRUG Vasopressin Vasopressin INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 19921001 UNAPPROVED DRUG OTHER American Regent, Inc. ARGIPRESSIN 20 [USP'U]/mL 0517-1045_ed6256cb-00cd-4d85-9d7a-25de3282544f 0517-1045 HUMAN PRESCRIPTION DRUG Levocarnitine Levocarnitine INJECTION, SOLUTION INTRAVENOUS 20011008 ANDA ANDA075861 American Regent, Inc. LEVOCARNITINE 200 mg/mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] 0517-1071_68b1bf4a-ca90-47f6-99b8-939e75f14601 0517-1071 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0517-1130_9c0aad7a-46d5-4185-bfbd-ec11897d4bd8 0517-1130 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19940301 UNAPPROVED DRUG OTHER American Regent, Inc. EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0517-1305_65363aba-6fcc-4710-a54b-a4a75b4060d3 0517-1305 HUMAN PRESCRIPTION DRUG Dopamine HCl Dopamine HCl INJECTION, SOLUTION INTRAVENOUS 19900930 ANDA ANDA070826 American Regent, Inc. DOPAMINE HYDROCHLORIDE 160 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0517-1355_8f6bd808-342f-404b-8943-6483641fe1d3 0517-1355 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 20100211 ANDA ANDA090386 American Regent, Inc. METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0517-1805_65363aba-6fcc-4710-a54b-a4a75b4060d3 0517-1805 HUMAN PRESCRIPTION DRUG Dopamine HCl Dopamine HCl INJECTION, SOLUTION INTRAVENOUS 19900930 ANDA ANDA070799 American Regent, Inc. DOPAMINE HYDROCHLORIDE 40 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0517-1905_65363aba-6fcc-4710-a54b-a4a75b4060d3 0517-1905 HUMAN PRESCRIPTION DRUG Dopamine HCl Dopamine HCl INJECTION, SOLUTION INTRAVENOUS 19900930 ANDA ANDA070820 American Regent, Inc. DOPAMINE HYDROCHLORIDE 80 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0517-2000_9548eb0b-412e-4ded-b441-f36cd9a50a87 0517-2000 HUMAN PRESCRIPTION DRUG Nutrilyte II Multi-Electrolyte INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19901001 UNAPPROVED DRUG OTHER American Regent, Inc. CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; SODIUM ACETATE; SODIUM CHLORIDE 16.55; 25.5; 98; 64.6; 74.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0517-2020_9548eb0b-412e-4ded-b441-f36cd9a50a87 0517-2020 HUMAN PRESCRIPTION DRUG Nutrilyte II Multi-Electrolyte INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19901001 UNAPPROVED DRUG OTHER American Regent, Inc. CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; SODIUM ACETATE; SODIUM CHLORIDE 16.55; 25.5; 98; 64.6; 74.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0517-2050_1923c5a9-ac44-43f3-9927-047f440ad6f4 0517-2050 HUMAN PRESCRIPTION DRUG L-Cysteine Hydrochloride L-Cysteine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20000101 UNAPPROVED DRUG OTHER American Regent, Inc. CYSTEINE HYDROCHLORIDE 50 mg/mL 0517-2053_85db0573-7200-41ba-9108-ba632c71dcca 0517-2053 HUMAN PRESCRIPTION DRUG Potassium Acetate Potassium Acetate INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. POTASSIUM ACETATE 196 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0517-2064_1923c5a9-ac44-43f3-9927-047f440ad6f4 0517-2064 HUMAN PRESCRIPTION DRUG L-Cysteine Hydrochloride L-Cysteine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. CYSTEINE HYDROCHLORIDE 50 mg/mL 0517-2096_6a5da55b-3199-4b98-a2a4-5efca91b3c91 0517-2096 HUMAN PRESCRIPTION DRUG Sodium Acetate Sodium Acetate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. SODIUM ACETATE ANHYDROUS 164 mg/mL 0517-2305_c95adfb7-d385-4504-8353-6983517e5513 0517-2305 HUMAN PRESCRIPTION DRUG potassium phosphates Potassium Phosphate, Monobasic and Potassium Phosphate, Dibasic INJECTION, SOLUTION INTRAVENOUS 19891119 UNAPPROVED DRUG OTHER American Regent, Inc. POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 236; 224 mg/mL; mg/mL 0517-2310_78454070-c19e-45cd-a267-3bea43f7113d 0517-2310 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20070612 NDA NDA021135 American Regent, Inc. IRON SUCROSE 20 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 0517-2315_c95adfb7-d385-4504-8353-6983517e5513 0517-2315 HUMAN PRESCRIPTION DRUG potassium phosphates Potassium Phosphate, Monobasic and Potassium Phosphate, Dibasic INJECTION, SOLUTION INTRAVENOUS 19891119 UNAPPROVED DRUG OTHER American Regent, Inc. POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 236; 224 mg/mL; mg/mL 0517-2325_78454070-c19e-45cd-a267-3bea43f7113d 0517-2325 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20110127 NDA NDA021135 American Regent, Inc. IRON SUCROSE 20 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 0517-2340_78454070-c19e-45cd-a267-3bea43f7113d 0517-2340 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20001110 NDA NDA021135 American Regent, Inc. IRON SUCROSE 20 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 0517-2350_c95adfb7-d385-4504-8353-6983517e5513 0517-2350 HUMAN PRESCRIPTION DRUG potassium phosphates Potassium Phosphate, Monobasic and Potassium Phosphate, Dibasic INJECTION, SOLUTION INTRAVENOUS 19891119 UNAPPROVED DRUG OTHER American Regent, Inc. POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 236; 224 mg/mL; mg/mL 0517-2502_cc74fb4c-d783-43a8-8151-925d9a40524b 0517-2502 HUMAN PRESCRIPTION DRUG Caffeine and Sodium Benzoate Caffeine and Sodium Benzoate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19930201 UNAPPROVED DRUG OTHER American Regent, Inc. CAFFEINE 125 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0517-2602_274e5d29-4332-4d4d-b78f-bd4361c5cb61 0517-2602 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0517-2610_274e5d29-4332-4d4d-b78f-bd4361c5cb61 0517-2610 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0517-2650_274e5d29-4332-4d4d-b78f-bd4361c5cb61 0517-2650 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0517-2710_35f0f3e5-deee-4f3d-996e-92a303d229f1 0517-2710 HUMAN PRESCRIPTION DRUG Calcium Chloride Calcium Chloride INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. CALCIUM CHLORIDE 100 mg/mL Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 0517-2810_0859ec99-9f2f-4523-9c03-2655e8517abd 0517-2810 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. SODIUM CHLORIDE 9 mg/mL 0517-2930_d99bb2b2-e708-40b2-9de1-4f8ba6bae976 0517-2930 HUMAN PRESCRIPTION DRUG Sodum Chloride Sodium Chloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS; SUBCUTANEOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. SODIUM CHLORIDE 234 mg/mL 0517-3005_389e9e22-8675-45d8-9f58-d9690010360d 0517-3005 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. WATER 1 mL/mL 0517-3010_389e9e22-8675-45d8-9f58-d9690010360d 0517-3010 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. WATER 1 mL/mL 0517-3020_389e9e22-8675-45d8-9f58-d9690010360d 0517-3020 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. WATER 1 mL/mL 0517-3050_389e9e22-8675-45d8-9f58-d9690010360d 0517-3050 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION, SOLUTION INTRAVENOUS 19800101 UNAPPROVED DRUG OTHER American Regent, Inc. WATER 1 mL/mL 0517-3065_b14ce76e-15ed-4c72-81fb-79d441245c19 0517-3065 HUMAN PRESCRIPTION DRUG Morrhuate Sodium Morrhuate Sodium INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. MORRHUATE SODIUM 50 mg/mL 0517-3120_551b56da-71af-4777-8a2b-3bfd7a391f1b 0517-3120 HUMAN PRESCRIPTION DRUG Nutrilyte Multi-Electrolyte INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. CALCIUM ACETATE; MAGNESIUM ACETATE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLUCONATE 22; 43; 34.5; 125; 135; 55 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0517-3405_29820a34-5673-4df4-9877-1657d3279f52 0517-3405 HUMAN PRESCRIPTION DRUG Sodium Phosphates sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 142; 276 mg/mL; mg/mL 0517-3415_29820a34-5673-4df4-9877-1657d3279f52 0517-3415 HUMAN PRESCRIPTION DRUG Sodium Phosphates sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 142; 276 mg/mL; mg/mL 0517-3450_29820a34-5673-4df4-9877-1657d3279f52 0517-3450 HUMAN PRESCRIPTION DRUG Sodium Phosphates sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 142; 276 mg/mL; mg/mL 0517-3605_a5e31568-7b97-483b-abbc-001c6a7f493f 0517-3605 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION, SOLUTION INTRAVENOUS 20120221 ANDA ANDA202143 American Regent, Inc. LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0517-3900_5178d569-7ff6-46de-a8ce-498e9608ef3f 0517-3900 HUMAN PRESCRIPTION DRUG Calcium Gluconate Calcium Gluconate INJECTION, SOLUTION INTRAVENOUS 19921201 UNAPPROVED DRUG OTHER American Regent, Inc. CALCIUM GLUCONATE MONOHYDRATE 98 mg/mL Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 0517-3950_5178d569-7ff6-46de-a8ce-498e9608ef3f 0517-3950 HUMAN PRESCRIPTION DRUG Calcium Gluconate Calcium Gluconate INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. CALCIUM GLUCONATE MONOHYDRATE 98 mg/mL Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 0517-4002_5ee8d0b3-841f-45a7-a363-76363ad481c1 0517-4002 HUMAN PRESCRIPTION DRUG Papaverine Hydrochloride Papaverine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19950901 UNAPPROVED DRUG OTHER American Regent, Inc. PAPAVERINE HYDROCHLORIDE 30 mg/mL 0517-4010_5ee8d0b3-841f-45a7-a363-76363ad481c1 0517-4010 HUMAN PRESCRIPTION DRUG Papaverine Hydrochloride Papaverine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19950901 UNAPPROVED DRUG OTHER American Regent, Inc. PAPAVERINE HYDROCHLORIDE 30 mg/mL 0517-4050_560eaf50-0d23-4df6-9068-eebba66634d4 0517-4050 HUMAN PRESCRIPTION DRUG Mannitol mannitol INJECTION, SOLUTION INTRAVENOUS 19900930 ANDA ANDA087409 American Regent, Inc. MANNITOL 250 mg/mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 0517-4201_7556bff3-b6b4-414b-8ae0-40e2cc63b39e 0517-4201 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 19900930 ANDA ANDA087408 American Regent, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0517-4601_6dd20e3a-5119-4003-a3ca-60d843914630 0517-4601 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19900930 ANDA ANDA089335 American Regent, Inc. GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0517-4602_6dd20e3a-5119-4003-a3ca-60d843914630 0517-4602 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19900930 ANDA ANDA089335 American Regent, Inc. GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0517-4605_6dd20e3a-5119-4003-a3ca-60d843914630 0517-4605 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19900930 ANDA ANDA089335 American Regent, Inc. GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0517-4620_6dd20e3a-5119-4003-a3ca-60d843914630 0517-4620 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19900930 ANDA ANDA089335 American Regent, Inc. GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0517-4810_f7f1a9e4-9103-4a84-9f31-cfbd5eeb33cb 0517-4810 HUMAN PRESCRIPTION DRUG Nitroglycerin nitroglycerin INJECTION, SOLUTION INTRAVENOUS 20030304 ANDA ANDA072034 American Regent, Inc. NITROGLYCERIN 5 mg/mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0517-4901_e4b6c252-64be-4e4a-88ba-3491d8fd7b3d 0517-4901 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 19900930 ANDA ANDA087440 American Regent, Inc. DEXAMETHASONE PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0517-4905_e4b6c252-64be-4e4a-88ba-3491d8fd7b3d 0517-4905 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 19900930 ANDA ANDA087440 American Regent, Inc. DEXAMETHASONE PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0517-4930_e4b6c252-64be-4e4a-88ba-3491d8fd7b3d 0517-4930 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 19900930 ANDA ANDA087440 American Regent, Inc. DEXAMETHASONE PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0517-5023_0954629f-ef6f-42d1-b3c9-409597fb8a24 0517-5023 HUMAN PRESCRIPTION DRUG Sodum Acetate Sodium Acetate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. SODIUM ACETATE ANHYDROUS 328 mg/mL 0517-5024_0f5c61fb-cf82-4332-a751-1c71f0ab8fb5 0517-5024 HUMAN PRESCRIPTION DRUG Potassium Acetate Potassium Acetate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. POTASSIUM ACETATE 392 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0517-5034_60f78290-bd1a-4931-8d99-d9417faacc38 0517-5034 HUMAN PRESCRIPTION DRUG Magnesium Chloride Magnesium Chloride INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. MAGNESIUM CHLORIDE 200 mg/mL 0517-5050_c1331a59-c0ec-4570-970a-770fe87b1f94 0517-5050 HUMAN PRESCRIPTION DRUG Ascorbic Acid Ascorbic Acid INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19891215 UNAPPROVED DRUG OTHER American Regent, Inc. ASCORBIC ACID 500 mg/mL 0517-5601_7556bff3-b6b4-414b-8ae0-40e2cc63b39e 0517-5601 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 19900930 ANDA ANDA087408 American Regent, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0517-5602_7556bff3-b6b4-414b-8ae0-40e2cc63b39e 0517-5602 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 19900930 ANDA ANDA087408 American Regent, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0517-5610_7556bff3-b6b4-414b-8ae0-40e2cc63b39e 0517-5610 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 19900930 ANDA ANDA087408 American Regent, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0517-5702_ef10f6be-4f9f-4d6d-aa84-f60d2f3d42b9 0517-5702 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION INTRAVENOUS 19900930 NDA NDA018579 American Regent, Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0517-5704_ef10f6be-4f9f-4d6d-aa84-f60d2f3d42b9 0517-5704 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION INTRAVENOUS 19900930 NDA NDA018579 American Regent, Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0517-5710_ef10f6be-4f9f-4d6d-aa84-f60d2f3d42b9 0517-5710 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION INTRAVENOUS 19900930 NDA NDA018579 American Regent, Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0517-6110_aa7dac70-f497-4191-b52a-a96cf25872a8 0517-6110 HUMAN PRESCRIPTION DRUG Zinc Sulfate Zinc Sulfate INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. ZINC SULFATE ANHYDROUS 1 mg/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 0517-6202_c8aa6a43-0e1f-43e5-a042-e3b3a3e931dd 0517-6202 HUMAN PRESCRIPTION DRUG Multitrace-4 Neonatal Trace Elements 4 INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; ZINC SULFATE HEPTAHYDRATE 4.36; .39; 77; 6.6 ug/mL; mg/mL; mg/mL; mg/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0517-6210_dab399d9-723e-4ef6-8ba7-c41ce2c1b48d 0517-6210 HUMAN PRESCRIPTION DRUG Cupric Sulfate Cupric Sulfate INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. CUPRIC SULFATE 1.57 mg/mL Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 0517-6310_b91ec5d3-06e4-46aa-81c1-5e44d99181b9 0517-6310 HUMAN PRESCRIPTION DRUG Chromic Chloride Chromic Chloride INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. CHROMIC CHLORIDE 20.5 ug/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0517-6510_b141a180-0ec0-43e9-a35e-80b87647f5a6 0517-6510 HUMAN PRESCRIPTION DRUG Selenium Selenium INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. SELENIOUS ACID 65.4 ug/mL 0517-6610_18d83044-4b09-45be-a6c4-00f4e6d3d3fb 0517-6610 HUMAN PRESCRIPTION DRUG Ammonium Molybdate Ammonium Molybdate INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. AMMONIUM MOLYBDATE 46 ug/mL 0517-6902_d8e455bc-e0b5-4abb-92a9-e878ceeb9ab9 0517-6902 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100730 ANDA ANDA090099 American Regent, Inc. FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0517-7201_1363db61-0998-419e-b305-a6a26538c2f8 0517-7201 HUMAN PRESCRIPTION DRUG Multitrace -4 Trace Elements 4 INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19931207 UNAPPROVED DRUG OTHER American Regent, Inc. CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; ZINC SULFATE HEPTAHYDRATE 51.3; 3.93; 1.54; 22 ug/mL; mg/mL; mg/mL; mg/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0517-7210_1363db61-0998-419e-b305-a6a26538c2f8 0517-7210 HUMAN PRESCRIPTION DRUG Multitrace -4 Trace Elements 4 INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19931129 UNAPPROVED DRUG OTHER American Regent, Inc. CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; ZINC SULFATE HEPTAHYDRATE 51.3; 3.93; 1.54; 22 ug/mL; mg/mL; mg/mL; mg/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0517-7410_6817d524-2100-4c8e-91c2-d1d2d999f31a 0517-7410 HUMAN PRESCRIPTION DRUG Multitrace-4 Trace Elements 4 INJECTION, SOLUTION INTRAVENOUS 19940217 UNAPPROVED DRUG OTHER American Regent, Inc. CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; ZINC SULFATE HEPTAHYDRATE 20.5; 1.57; .308; 4.39 ug/mL; mg/mL; mg/mL; mg/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0517-7504_2fdbe3e6-e9ee-4f6f-b2f8-391bf741bc5f 0517-7504 HUMAN PRESCRIPTION DRUG Acetylcysteine acetylcysteine INHALANT RESPIRATORY (INHALATION) 19951001 ANDA ANDA072489 American Regent, Inc. ACETYLCYSTEINE 100 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 0517-7510_2fdbe3e6-e9ee-4f6f-b2f8-391bf741bc5f 0517-7510 HUMAN PRESCRIPTION DRUG Acetylcysteine acetylcysteine INHALANT RESPIRATORY (INHALATION) 19951001 ANDA ANDA072489 American Regent, Inc. ACETYLCYSTEINE 100 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 0517-7604_2fdbe3e6-e9ee-4f6f-b2f8-391bf741bc5f 0517-7604 HUMAN PRESCRIPTION DRUG Acetylcysteine acetylcysteine INHALANT RESPIRATORY (INHALATION) 19951001 ANDA ANDA072547 American Regent, Inc. ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 0517-7610_2fdbe3e6-e9ee-4f6f-b2f8-391bf741bc5f 0517-7610 HUMAN PRESCRIPTION DRUG Acetylcysteine acetylcysteine INHALANT RESPIRATORY (INHALATION) 19951001 ANDA ANDA072547 American Regent, Inc. ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 0517-7630_2fdbe3e6-e9ee-4f6f-b2f8-391bf741bc5f 0517-7630 HUMAN PRESCRIPTION DRUG Acetylcysteine acetylcysteine INHALANT RESPIRATORY (INHALATION) 19951001 ANDA ANDA072547 American Regent, Inc. ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 0517-8105_366c9858-7cda-46f9-83a3-e2dafb00a05c 0517-8105 HUMAN PRESCRIPTION DRUG Zinc Sulfate Zinc Sulfate INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. ZINC SULFATE ANHYDROUS 12.32 mg/mL 0517-8201_dc0753e4-a17a-4020-bba8-8e78a40e031b 0517-8201 HUMAN PRESCRIPTION DRUG Multitrace-5 Trace Elements 5 INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19931217 UNAPPROVED DRUG OTHER American Regent, Inc. CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE HEPTAHYDRATE 51.3; 3.93; 1.54; 98; 22 ug/mL; mg/mL; mg/mL; ug/mL; mg/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0517-8210_dc0753e4-a17a-4020-bba8-8e78a40e031b 0517-8210 HUMAN PRESCRIPTION DRUG Multitrace-5 Trace Elements 5 INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19930914 UNAPPROVED DRUG OTHER American Regent, Inc. CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE HEPTAHYDRATE 51.3; 3.93; 1.54; 98; 22 ug/mL; mg/mL; mg/mL; ug/mL; mg/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0517-8510_9a7f5368-6696-4835-83da-b2358179720c 0517-8510 HUMAN PRESCRIPTION DRUG Multitrace-5 Trace Elements 5 INJECTION, SOLUTION INTRAVENOUS 19940217 UNAPPROVED DRUG OTHER American Regent, Inc. CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE HEPTAHYDRATE 20.5; 1.57; .308; 32.7; 4.39 ug/mL; mg/mL; mg/mL; ug/mL; mg/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0517-8571_75cdf916-e28d-44db-8204-0aa4f23701b8 0517-8571 HUMAN PRESCRIPTION DRUG Dehydrated Alcohol Dehydrated Alcohol INJECTION, SOLUTION INTRASPINAL 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. ALCOHOL .98 mL/mL 0517-8575_75cdf916-e28d-44db-8204-0aa4f23701b8 0517-8575 HUMAN PRESCRIPTION DRUG Dehydrated Alcohol Dehydrated Alcohol INJECTION, SOLUTION INTRASPINAL 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. ALCOHOL .98 mL/mL 0517-8880_72f1cd57-ffa9-4814-8403-de4d69dd86d7 0517-8880 HUMAN PRESCRIPTION DRUG Sprix ketorolac tromethamine SPRAY, METERED NASAL 20110426 NDA NDA022382 American Regent, Inc. KETOROLAC TROMETHAMINE 15.75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0517-8905_2627d4f7-5db1-49e0-bf19-0027ab27197b 0517-8905 HUMAN PRESCRIPTION DRUG Methyldopate Hydrochloride Methyldopate Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19950930 ANDA ANDA071279 American Regent, Inc. METHYLDOPATE HYDROCHLORIDE 50 mg/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0517-9120_a34e920d-92fc-4a62-9a35-fb19b35a116f 0517-9120 HUMAN PRESCRIPTION DRUG Aminocaproic Acid Aminocaproic Acid INJECTION, SOLUTION INTRAVENOUS 19900930 ANDA ANDA071192 American Regent, Inc. AMINOCAPROIC ACID 250 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 0517-9203_bf116d1d-8143-4ba5-a987-4dbfd2a695de 0517-9203 HUMAN PRESCRIPTION DRUG Multitrace -4 Pediatric Trace Elements 4 INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19931209 UNAPPROVED DRUG OTHER American Regent, Inc. CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; ZINC SULFATE HEPTAHYDRATE 5.12; .4; 77; 4.39 ug/mL; mg/mL; ug/mL; mg/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0517-9310_0f5d052e-392d-4538-b2ff-c802bff561d2 0517-9310 HUMAN PRESCRIPTION DRUG Trace Elements 4 Trace Elements 4 INJECTION, SOLUTION INTRAVENOUS 19940224 UNAPPROVED DRUG OTHER American Regent, Inc. CHROMIC CHLORIDE; CUPRIC SULFATE; MANGANESE SULFATE; ZINC SULFATE HEPTAHYDRATE 5.12; .4; 92.3; 2.2 ug/mL; mg/mL; ug/mL; mg/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0517-9702_b135de7c-8def-431a-a5cc-1c1d98cc6161 0517-9702 HUMAN PRESCRIPTION DRUG Droperidol Droperidol INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19900930 ANDA ANDA072123 American Regent, Inc. DROPERIDOL 2.5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0519-1171_7dfe678c-b2f3-4d81-b123-28817c85adb5 0519-1171 HUMAN OTC DRUG Kindest Kare Antimicrobial Hand and Body Wash Triclosan LIQUID TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation TRICLOSAN .2 g/100mL 0519-1181_26901dd5-03af-431f-a4f9-e988a4423dc4 0519-1181 HUMAN OTC DRUG Cal Stat Plus Antiseptic Handrub with Enhanced Emollients Isopropyl Alcohol LIQUID TOPICAL 20110318 OTC MONOGRAPH NOT FINAL part333A STERIS Corporation ISOPROPYL ALCOHOL 63 mL/100mL 0519-1199_92e384a9-7763-4675-aa3f-41e3a501ad03 0519-1199 HUMAN OTC DRUG Kindest Kare Foam Antiseptic Handrub with Enhanced Emollients alcohol LIQUID TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation ALCOHOL 62 mg/100mL 0519-1229_8551b72a-d940-4d39-84b6-284355fee223 0519-1229 HUMAN OTC DRUG Medicated Soft N Sure Healthcare Personnel Handwash Triclosan LIQUID TOPICAL 19951101 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation TRICLOSAN .5 g/1000mL 0519-1322_2e52fa58-76f0-40cb-8b1d-671fcd35b7c8 0519-1322 HUMAN OTC DRUG Bactoshield CHG Chlorhexidine Gluconate SOLUTION TOPICAL 19991004 NDA NDA019422 STERIS Corporation CHLORHEXIDINE GLUCONATE 20 mg/mL 0519-1344_01ab5f17-2ccf-41d6-bd83-56c9a9b9f717 0519-1344 HUMAN OTC DRUG Bactoshield CHG CHLORHEXIDINE GLUCONATE SOLUTION TOPICAL 19991004 NDA NDA019125 STERIS Corporation CHLORHEXIDINE GLUCONATE 40 mg/mL 0519-1357_5c05a90c-4289-4dc7-9b05-e3aa2b204030 0519-1357 HUMAN OTC DRUG Septisol NPD with Triclosan Antiseptic Triclosan LIQUID TOPICAL 20110325 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation TRICLOSAN .25 mL/100mL 0519-1364_5d97c868-f283-4974-95d2-7ee75f9bb669 0519-1364 HUMAN OTC DRUG Bactoshield CHLORHEXIDINE GLUCONATE SPONGE TOPICAL 20030327 NDA NDA019822 STERIS Corporation CHLORHEXIDINE GLUCONATE 40 mg/mL 0519-1381_4022b015-4653-413a-8435-5c59ca027a93 0519-1381 HUMAN OTC DRUG Soft N Sure Foamed Antiseptic Handrub ALCOHOL AEROSOL, FOAM TOPICAL 20060411 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation ALCOHOL 62 g/100g 0519-1440_fb60bc84-0db8-4052-8d80-1f88b8240487 0519-1440 HUMAN OTC DRUG Soft N Sure Antiseptic Alcohol GEL TOPICAL 20110316 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation ALCOHOL 65 mL/100mL 0519-1452_de18f0b8-6eb1-4750-917d-da97fe2d95fc 0519-1452 HUMAN OTC DRUG Kindest Kare Antimicrobial Foaming Handwash Healthcare Personnel Handwash Triclosan LIQUID TOPICAL 20060314 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation TRICLOSAN .75 g/100mL 0519-1458_bc867bf5-372a-4d05-9ea2-39f401b72db1 0519-1458 HUMAN OTC DRUG Kindest Kare Air-Infused Foam Antiseptic Handrub ALCOHOL LIQUID TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation ALCOHOL 62 mg/100mL 0519-6262_d3d10a9f-68d6-42c9-a8fd-789c337bbde4 0519-6262 HUMAN OTC DRUG CV Medicated TRICLOSAN SOAP TOPICAL 20030327 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation TRICLOSAN .5 g/100mL 0519-6395_6e8bb5ff-c2e7-4b4b-98df-eb4b29719788 0519-6395 HUMAN OTC DRUG Alcare Foamed Antiseptic Handrub ALCOHOL AEROSOL, FOAM TOPICAL 19980120 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation ALCOHOL 62 g/100g 0519-6396_222427a6-625d-4c4d-b014-c240e5cc2d57 0519-6396 HUMAN OTC DRUG Alcare OR Foamed Antiseptic Handrub ALCOHOL AEROSOL, FOAM TOPICAL 20050208 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation ALCOHOL 62 g/100g 0519-6399_2f31f26b-f9c4-424e-b23a-01ab2a6d1edc 0519-6399 HUMAN OTC DRUG Alcare Plus Foamed Antiseptic Handrub alcohol AEROSOL, FOAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation ALCOHOL 62 g/100g 0519-8801_5ab550a4-f4df-44cc-9f89-5e91465481e6 0519-8801 HUMAN OTC DRUG Dignity Health Hand Sanitizer Alcare Plus ALCOHOL AEROSOL, FOAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation ALCOHOL 62 g/100g 0519-8802_1b5b5283-53e0-4c32-b9b9-16058f0b99ce 0519-8802 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140908 OTC MONOGRAPH NOT FINAL part333A Steris Corporation ALCOHOL 578 mg/mL 0519-8803_ee4eab8a-288a-467d-aedd-f3824cc86f6a 0519-8803 HUMAN OTC DRUG Dignity Health Hand Sanitizer Cal Stat Plus Antiseptic Handrub with Enhanced Emollients Isopropyl Alcohol LIQUID TOPICAL 20140317 OTC MONOGRAPH NOT FINAL part333A STERIS Corporation ISOPROPYL ALCOHOL 63 mL/100mL 0525-6748_ed7c8f38-2ea4-4fff-af23-6181dd04d539 0525-6748 HUMAN PRESCRIPTION DRUG Palgic carbinoxamine maleate TABLET ORAL 20030821 ANDA ANDA040442 Pamlab, L.L.C. CARBINOXAMINE MALEATE 4 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0525-6752_ed7c8f38-2ea4-4fff-af23-6181dd04d539 0525-6752 HUMAN PRESCRIPTION DRUG Palgic carbinoxamine maleate SOLUTION ORAL 20030812 ANDA ANDA040458 Pamlab, L.L.C. CARBINOXAMINE MALEATE 4 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0527-0586_0b26d604-2008-4de8-b307-7f6d6e7e3188 0527-0586 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19740930 ANDA ANDA084285 Lannett Company, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0527-0597_310938e2-f287-4147-99d5-c3d9a3a27438 0527-0597 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 Lannett Company, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0527-1050_2bcec12f-959b-469c-9b0a-37a8c75129a7 0527-1050 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE Acetazolamide TABLET ORAL 19780331 ANDA ANDA084840 Lannett Company, Inc. ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 0527-1109_bd43b774-63ea-4b24-8a65-26b56b331d98 0527-1109 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL; ORAL 20131010 ANDA ANDA089776 Lannett Company, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] 0527-1231_803b70e5-6218-4489-89c5-22ae2dcadff5 0527-1231 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 19781201 ANDA ANDA084903 Lannett Company, Inc. PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0527-1282_0b26d604-2008-4de8-b307-7f6d6e7e3188 0527-1282 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19990226 ANDA ANDA040230 Lannett Company, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0527-1301_803b70e5-6218-4489-89c5-22ae2dcadff5 0527-1301 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20010524 ANDA ANDA084903 Lannett Company, Inc. PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0527-1308_310938e2-f287-4147-99d5-c3d9a3a27438 0527-1308 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 Lannett Company, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0527-1310_310938e2-f287-4147-99d5-c3d9a3a27438 0527-1310 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 Lannett Company, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0527-1311_1a9eafe9-63a6-4c56-95e8-2d02b2d4f2cb 0527-1311 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate TABLET ORAL 20050325 ANDA ANDA077152 Lannett Company, Inc. TERBUTALINE SULFATE 5 mg/1 0527-1312_2226a799-64cc-4e4d-8f4c-2045afd00063 0527-1312 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, Caffeine and Codeine Phosphate Butalbital, Aspirin, Caffeine and Codeine Phosphate CAPSULE ORAL 19980831 ANDA ANDA074951 Lannett Company, Inc. ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0527-1313_ee233d4f-dda5-4eb0-8a4a-6ef722b40f1b 0527-1313 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride TABLET, FILM COATED ORAL 20060131 ANDA ANDA077220 Lannett Company, Inc. PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 0527-1315_520b01c7-a2fd-4d41-b604-bbee86d27049 0527-1315 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20080420 ANDA ANDA065390 Lannett Company, Inc. RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 0527-1318_1a9eafe9-63a6-4c56-95e8-2d02b2d4f2cb 0527-1318 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate TABLET ORAL 20050325 ANDA ANDA077152 Lannett Company, Inc. TERBUTALINE SULFATE 2.5 mg/1 0527-1324_c240d91d-2c25-4fd4-a900-d01b4df045d0 0527-1324 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Lannett Company, Inc. DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0527-1325_c240d91d-2c25-4fd4-a900-d01b4df045d0 0527-1325 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Lannett Company, Inc. DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0527-1326_42a86e84-ca90-4a4a-9d75-9536e2e509d5 0527-1326 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20090101 ANDA ANDA079082 Lannett Company, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 0527-1329_a2f2f992-d1ca-4dfb-84ec-440a74b30d16 0527-1329 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20080327 ANDA ANDA040677 Lannett Company, Inc. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0527-1330_521cfc99-7228-4dd3-ad2e-d06df39a0fb1 0527-1330 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20070701 ANDA ANDA078220 Lannett Company, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 0527-1332_a2f2f992-d1ca-4dfb-84ec-440a74b30d16 0527-1332 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20080327 ANDA ANDA040703 Lannett Company, Inc. BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0527-1335_2e5c0682-05a5-43c9-89c3-53bc80d7c2b3 0527-1335 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20051208 ANDA ANDA065285 Lannett Company, Inc. DOXYCYCLINE 50 mg/1 0527-1336_12fbbbe0-ddff-4f40-8202-c5fa06113f8b 0527-1336 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20051110 ANDA ANDA065277 Lannett Company, Inc. DOXYCYCLINE HYCLATE 20 mg/1 0527-1337_521cfc99-7228-4dd3-ad2e-d06df39a0fb1 0527-1337 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20051201 ANDA ANDA077241 Lannett Company, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 0527-1338_2e5c0682-05a5-43c9-89c3-53bc80d7c2b3 0527-1338 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20051208 ANDA ANDA065285 Lannett Company, Inc. DOXYCYCLINE 100 mg/1 0527-1340_a2f2f992-d1ca-4dfb-84ec-440a74b30d16 0527-1340 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20080327 ANDA ANDA040704 Lannett Company, Inc. BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0527-1341_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1341 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1342_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1342 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1343_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1343 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1344_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1344 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1345_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1345 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1346_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1346 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1347_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1347 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1349_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1349 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1350_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1350 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1351_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1351 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1352_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1352 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .3 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1353_a59ae28a-f3f8-4de1-b993-1f9682d051ef 0527-1353 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA078439 Lannett Company, Inc. HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0527-1354_a59ae28a-f3f8-4de1-b993-1f9682d051ef 0527-1354 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA078439 Lannett Company, Inc. HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0527-1355_a59ae28a-f3f8-4de1-b993-1f9682d051ef 0527-1355 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA077471 Lannett Company, Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0527-1356_a2f2f992-d1ca-4dfb-84ec-440a74b30d16 0527-1356 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20080327 ANDA ANDA040678 Lannett Company, Inc. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0527-1366_5adc3ccc-d92b-46dd-b33f-9d3af2f37cb7 0527-1366 HUMAN PRESCRIPTION DRUG Phentermine Resin ER Phentermine Resin CAPSULE, EXTENDED RELEASE ORAL 20110728 ANDA ANDA040872 Lannett Company, Inc. PHENTERMINE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0527-1367_77b3cbea-caa8-49a8-b3e6-23aa42023da1 0527-1367 HUMAN PRESCRIPTION DRUG Probenecid Probenecid TABLET, FILM COATED ORAL 19760729 ANDA ANDA080966 Lannett Company, Inc. PROBENECID 500 mg/1 0527-1368_49ad0a91-954c-4a05-800d-7f8e822ac904 0527-1368 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 20070419 ANDA ANDA078214 Lannett Company, Inc. DANAZOL 100 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 0527-1369_49ad0a91-954c-4a05-800d-7f8e822ac904 0527-1369 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 20050928 ANDA ANDA077246 Lannett Company, Inc. DANAZOL 200 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 0527-1370_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1370 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1371_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1371 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1372_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1372 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1373_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1373 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1374_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1374 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1375_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1375 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1376_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1376 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1377_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1377 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1378_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1378 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1379_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1379 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1380_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1380 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .3 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1381_06c4923d-b128-4ea9-aab5-b7a55b890de7 0527-1381 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20050812 ANDA ANDA065242 Lannett Company, Inc. CLINDAMYCIN HYDROCHLORIDE 75 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0527-1382_06c4923d-b128-4ea9-aab5-b7a55b890de7 0527-1382 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20050812 ANDA ANDA065242 Lannett Company, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0527-1383_06c4923d-b128-4ea9-aab5-b7a55b890de7 0527-1383 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20050812 ANDA ANDA065243 Lannett Company, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0527-1392_49ad0a91-954c-4a05-800d-7f8e822ac904 0527-1392 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 20070419 ANDA ANDA078214 Lannett Company, Inc. DANAZOL 50 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 0527-1393_520b01c7-a2fd-4d41-b604-bbee86d27049 0527-1393 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20080420 ANDA ANDA065390 Lannett Company, Inc. RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 0527-1394_1653a376-edfa-4b22-88b7-f0d6395be0fb 0527-1394 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20110926 ANDA ANDA090695 Lannett Company, Inc. LOXAPINE SUCCINATE 5 mg/1 0527-1395_1653a376-edfa-4b22-88b7-f0d6395be0fb 0527-1395 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20110926 ANDA ANDA090695 Lannett Company, Inc. LOXAPINE SUCCINATE 10 mg/1 0527-1396_1653a376-edfa-4b22-88b7-f0d6395be0fb 0527-1396 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20110926 ANDA ANDA090695 Lannett Company, Inc. LOXAPINE SUCCINATE 25 mg/1 0527-1397_1653a376-edfa-4b22-88b7-f0d6395be0fb 0527-1397 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20110926 ANDA ANDA090695 Lannett Company, Inc. LOXAPINE SUCCINATE 50 mg/1 0527-1398_5adc3ccc-d92b-46dd-b33f-9d3af2f37cb7 0527-1398 HUMAN PRESCRIPTION DRUG Phentermine Resin ER Phentermine Resin CAPSULE, EXTENDED RELEASE ORAL 20110728 ANDA ANDA040872 Lannett Company, Inc. PHENTERMINE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0527-1407_ee233d4f-dda5-4eb0-8a4a-6ef722b40f1b 0527-1407 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride TABLET, FILM COATED ORAL 20090810 ANDA ANDA077220 Lannett Company, Inc. PILOCARPINE HYDROCHLORIDE 7.5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 0527-1413_23da94e7-00ec-465e-9ab5-82e3e411f194 0527-1413 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070501 ANDA ANDA084325 Lannett Company, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0527-1414_23da94e7-00ec-465e-9ab5-82e3e411f194 0527-1414 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070501 ANDA ANDA084324 Lannett Company, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0527-1425_030319f6-9a9f-449d-9225-66bb1e531433 0527-1425 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION, CONCENTRATE ORAL 20110623 NDA NDA201517 Lannett Company, Inc. MORPHINE SULFATE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0527-1426_8543a55b-c986-47db-8784-3e24c5ed7ea2 0527-1426 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20140910 ANDA ANDA204085 Lannett Company, Inc. OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0527-1438_310938e2-f287-4147-99d5-c3d9a3a27438 0527-1438 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20100719 ANDA ANDA091359 Lannett Company, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0527-1445_a492eb97-37a9-47af-8266-fdad8d41c8cf 0527-1445 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20050415 ANDA ANDA040555 Lannett Company, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0527-1461_2210856e-0bac-4af3-89cd-238b46efe6e2 0527-1461 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080423 ANDA ANDA040898 Lannett Company, Inc. DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0527-1462_2210856e-0bac-4af3-89cd-238b46efe6e2 0527-1462 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080423 ANDA ANDA040898 Lannett Company, Inc. DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0527-1463_2210856e-0bac-4af3-89cd-238b46efe6e2 0527-1463 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080423 ANDA ANDA040898 Lannett Company, Inc. DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0527-1475_c9f64b22-08e3-413e-9866-cf9d365b1033 0527-1475 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride Diethylpropion Hydrochloride TABLET ORAL 20110718 ANDA ANDA200177 Lannett Company, Inc. DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0527-1477_bed65a86-a1bd-479b-9ffa-05d129d095ba 0527-1477 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride ER Diethylpropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111024 ANDA ANDA091680 Lannett Company, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0527-1535_2e5c0682-05a5-43c9-89c3-53bc80d7c2b3 0527-1535 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20080825 ANDA ANDA065285 Lannett Company, Inc. DOXYCYCLINE 75 mg/1 0527-1537_2e5c0682-05a5-43c9-89c3-53bc80d7c2b3 0527-1537 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20080825 ANDA ANDA065285 Lannett Company, Inc. DOXYCYCLINE 150 mg/1 0527-1552_dfdc2b93-3d92-4738-9af9-f075eadb999b 0527-1552 HUMAN PRESCRIPTION DRUG Butalbital, aspirin, and caffeine Butalbital, aspirin, and caffeine CAPSULE ORAL 19851011 ANDA ANDA086996 Lannett Company, Inc. ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 0527-1632_bfeaab2e-0127-48ea-8e2e-79caa24dc906 0527-1632 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 20111212 ANDA ANDA201407 Lannett Company, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0527-1635_1d8e77d7-2c00-4f9a-bea8-245641d3cd4a 0527-1635 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20120127 ANDA ANDA091662 Lannett Company, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0527-1638_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1638 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20071001 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1639_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1639 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20071001 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0527-1695_9de3d8e7-22d9-440d-a1c3-6e04daa26737 0527-1695 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20120913 ANDA ANDA200243 Lannett Company, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0527-1698_1609dd11-df35-45e8-a15a-1aa8cb4219df 0527-1698 HUMAN PRESCRIPTION DRUG Codeine Sulfate Codeine Sulfate TABLET ORAL 20140613 ANDA ANDA203046 Lannett Company, Inc. CODEINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0527-1699_1609dd11-df35-45e8-a15a-1aa8cb4219df 0527-1699 HUMAN PRESCRIPTION DRUG Codeine Sulfate Codeine Sulfate TABLET ORAL 20140613 ANDA ANDA203046 Lannett Company, Inc. CODEINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0527-1704_64f41f85-5e90-45e6-b0c1-b05ec665ea68 0527-1704 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 20081101 ANDA ANDA078720 Lannett Company, Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 0527-1712_28ffce0b-430d-426c-a355-b8347338c10f 0527-1712 HUMAN PRESCRIPTION DRUG Letrozole Letrozole TABLET, FILM COATED ORAL 20141029 ANDA ANDA202048 Lannett Company, Inc. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 0527-1726_89ab7f0a-a8c9-43aa-a3e1-14cd6e318d61 0527-1726 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20100701 ANDA ANDA090116 Lannett Company, Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0527-1727_1609dd11-df35-45e8-a15a-1aa8cb4219df 0527-1727 HUMAN PRESCRIPTION DRUG Codeine Sulfate Codeine Sulfate TABLET ORAL 20140613 ANDA ANDA203046 Lannett Company, Inc. CODEINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0527-1728_67fdc833-c269-422f-b19e-f6eea313ecd4 0527-1728 HUMAN PRESCRIPTION DRUG Cocaine Hydrochloride Cocaine Hydrochloride SOLUTION TOPICAL 20081201 UNAPPROVED DRUG OTHER Lannett Company, Inc. COCAINE HYDROCHLORIDE 40 mg/mL CII 0527-1729_67fdc833-c269-422f-b19e-f6eea313ecd4 0527-1729 HUMAN PRESCRIPTION DRUG Cocaine Hydrochloride Cocaine Hydrochloride SOLUTION TOPICAL 20081201 UNAPPROVED DRUG OTHER Lannett Company, Inc. COCAINE HYDROCHLORIDE 100 mg/mL CII 0527-1742_310938e2-f287-4147-99d5-c3d9a3a27438 0527-1742 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120120 ANDA ANDA087022 Lannett Company, Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0527-1743_4e79a457-2577-4aa3-87e2-ef3eb6df1fbd 0527-1743 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20110720 ANDA ANDA201961 Lannett Company, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0527-1763_b981255a-fe82-4953-9f3c-04977df0d9d2 0527-1763 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride-Timolol Maleate Dorzolamide Hydrochloride-Timolol Maleate SOLUTION OPHTHALMIC 20141217 ANDA ANDA201998 Lannett Company, Inc. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0527-1768_24dd286a-0f90-42e1-a4e9-7ae519f367d8 0527-1768 HUMAN PRESCRIPTION DRUG Diazepam Diazepam SOLUTION, CONCENTRATE ORAL 20140414 ANDA ANDA204433 Lannett Company, Inc. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0527-1774_0c019f23-3564-4a97-89c0-49c9ba67a2ad 0527-1774 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE ORAL 20140801 ANDA ANDA203823 Lannett Company, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0527-1788_84a6eb2e-311d-4c17-839c-49083ed86936 0527-1788 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20100927 ANDA ANDA089740 Lannett Company, Inc. FLUPHENAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0527-1789_84a6eb2e-311d-4c17-839c-49083ed86936 0527-1789 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20100927 ANDA ANDA089741 Lannett Company, Inc. FLUPHENAZINE HYDROCHLORIDE 2.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0527-1790_84a6eb2e-311d-4c17-839c-49083ed86936 0527-1790 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20100927 ANDA ANDA089742 Lannett Company, Inc. FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0527-1791_84a6eb2e-311d-4c17-839c-49083ed86936 0527-1791 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20100927 ANDA ANDA089743 Lannett Company, Inc. FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0527-1905_17a82c45-d7ee-4e68-b240-e04fca25229c 0527-1905 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20140325 ANDA ANDA202058 Lannett Company, Inc. ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0527-1919_3c07919a-a38c-4a38-a761-65196c8c7883 0527-1919 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20141001 NDA NDA020184 Lannett Company, Inc. PERINDOPRIL ERBUMINE 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0527-1920_3c07919a-a38c-4a38-a761-65196c8c7883 0527-1920 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20141001 NDA NDA020184 Lannett Company, Inc. PERINDOPRIL ERBUMINE 8 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0535-0011_be7067af-909b-471c-ab29-1028b3c547b7 0535-0011 HUMAN PRESCRIPTION DRUG Esgic butalbital, acetaminophen and caffeine TABLET ORAL 19970601 ANDA ANDA089175 Forest Laboratories, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0535-0012_e48295c8-7ceb-4cf1-ad14-3857785bde77 0535-0012 HUMAN PRESCRIPTION DRUG Esgic butalbital, acetaminophen and caffeine CAPSULE ORAL 19970409 ANDA ANDA089007 Forest Laboratories, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0536-0015_3d00faa4-581a-4410-bf8f-6c369fd67028 0536-0015 HUMAN OTC DRUG ALMACONE DOUBLE STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110105 OTC MONOGRAPH FINAL part331 Rugby Laboratories, Inc. ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 0536-0025_ab2c070e-d0d4-4f1a-979a-771fb93f7efb 0536-0025 HUMAN OTC DRUG ALMACONE ANTACID ANTIGAS aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110105 OTC MONOGRAPH FINAL part331 Rugby Laboratories, Inc. ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 0536-0091_0c4d5b0e-bbd4-4089-bd86-28c7a7d1f5a3 0536-0091 HUMAN OTC DRUG Aluminum Hydroxide aluminum hydroxide LIQUID ORAL 20050201 OTC MONOGRAPH FINAL part331 Rugby Laboratories, Inc. ALUMINUM HYDROXIDE 320 mg/5mL 0536-0122_4296494d-99c4-486b-a7df-23d083e5643f 0536-0122 HUMAN OTC DRUG Rugby Acetaminophen Acetaminophen LIQUID ORAL 20110428 OTC MONOGRAPH NOT FINAL part343 Rugby Laboratories, Inc. ACETAMINOPHEN 160 mg/5mL 0536-0355_75e5bef2-e044-4d11-8a79-29d039a50f35 0536-0355 HUMAN OTC DRUG Docusate Sodium and Senna Docusate Sodium and Senna TABLET, FILM COATED ORAL 20110922 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories, Inc DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 0536-0370_3065bc51-c210-483b-876d-14a4d060bdec 0536-0370 HUMAN OTC DRUG Aller-Chlor Chlorpheniramine Maleate SYRUP ORAL 20030117 OTC MONOGRAPH FINAL part341 Rugby Laboratories, Inc. CHLORPHENIRAMINE MALEATE 2 mg/5mL 0536-0590_a5504a8d-6b8f-47a3-8016-c1b3e0ea3cfe 0536-0590 HUMAN OTC DRUG Diocto Docusate Sodium LIQUID ORAL 20130301 OTC MONOGRAPH NOT FINAL part334 The Harvard Drug Group, LLC DOCUSATE SODIUM 50 mg/5mL 0536-0600_afac6c3d-a513-4655-9545-3e489f26558a 0536-0600 HUMAN OTC DRUG Diocto docusate sodium SYRUP ORAL 19991001 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories, Inc. DOCUSATE SODIUM 60 mg/15mL 0536-0770_bfe8cea5-5e90-4d23-adb7-0af8f884cd5e 0536-0770 HUMAN OTC DRUG Diphenhist Diphenhydramine Hydrochloride LIQUID ORAL 20090926 OTC MONOGRAPH FINAL part341 Rugby Laboratories Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 0536-0810_57391419-7fdf-49d8-bac7-0ce353f0a835 0536-0810 HUMAN OTC DRUG ACNE MEDICATION 5 BENZOYL PEROXIDE LOTION TOPICAL 20121029 OTC MONOGRAPH FINAL part333D Rugby Laboratories BENZOYL PEROXIDE 50 mg/1000mL 0536-0815_d4e80132-a7d9-453c-813b-fbcf883f198e 0536-0815 HUMAN OTC DRUG ACNE MEDICATION 10 BENZOYL PEROXIDE LOTION TOPICAL 20121029 OTC MONOGRAPH FINAL part333D Rugby Laboratories BENZOYL PEROXIDE 100 mg/1000mL 0536-0825_0d89352c-b6d8-4c7b-8d63-c5f8e503ef79 0536-0825 HUMAN OTC DRUG Cough Guaifenesin LIQUID ORAL 20091204 OTC MONOGRAPH FINAL part341 Rugby Laboratories Inc. GUAIFENESIN 100 mg/5mL 0536-0901_dfe515f7-90d3-46f1-988c-ce5d9f083d4b 0536-0901 HUMAN OTC DRUG Eye Irrigating Purified Water SOLUTION OPHTHALMIC 20111007 UNAPPROVED DRUG OTHER Rugby Laboratories Inc. WATER 99.05 mL/100mL 0536-0940_7f4b0600-8d8c-40e1-bd95-27020894995e 0536-0940 HUMAN OTC DRUG Eye Drops Tetrahydrozoline HCl SOLUTION/ DROPS OPHTHALMIC 20111007 OTC MONOGRAPH FINAL part349 Rugby Laboratories Inc. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 0536-0970_2242a79c-0ee8-4027-890b-704f3fd0928b 0536-0970 HUMAN OTC DRUG Extra action Cough Guaifenesin and DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20110203 OTC MONOGRAPH FINAL part341 Rugby Laboratories Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 0536-1000_5f6f41df-7a68-4cd2-a1c4-2b1bde5bd2fe 0536-1000 HUMAN OTC DRUG Senexon Sennosides A and B SYRUP ORAL 20130215 OTC MONOGRAPH NOT FINAL part334 The Harvard Drug Group, LLC SENNOSIDES A AND B 8.8 mg/5mL 0536-1001_65d6d66a-bdaf-4cba-93e3-e73f3029b102 0536-1001 HUMAN OTC DRUG Diocto Docusate Sodium SYRUP ORAL 20130601 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories DOCUSATE SODIUM 60 mg/15mL 0536-1002_39ed24f0-4a60-4db4-8831-9a9edf1c2321 0536-1002 HUMAN OTC DRUG Rugby Eye Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20130630 OTC MONOGRAPH FINAL part349 Rugby Laboratories, Inc. TETRAHYDROZOLINE HYDROCHLORIDE .05 mg/mg 0536-1003_d22db5f2-49d3-409e-a460-4e09b53f90f8 0536-1003 HUMAN OTC DRUG ACETA-GESIC ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20140630 OTC MONOGRAPH FINAL part341 Rugby Laboratories ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 325; 12.5 mg/1; mg/1 0536-1004_18d9ecaa-7be6-419c-9aa2-231b2e55c82a 0536-1004 HUMAN OTC DRUG Aspirin aspirin TABLET, COATED ORAL 20140114 OTC MONOGRAPH FINAL part343 RUGBY LABORATORIES, INC ASPIRIN 81 mg/1 0536-1005_1f184b23-e3f0-4403-8c89-77f973703625 0536-1005 HUMAN OTC DRUG Childrens Allergy Fexofenadine Hydrochloride Fexofenadine Hydrochloride SUSPENSION ORAL 20141219 ANDA ANDA203330 Rugby Laboratories FEXOFENADINE HYDROCHLORIDE 30 mg/5mL 0536-1006_8ce7e2c4-52dd-494b-89ec-c5ba64dc6451 0536-1006 HUMAN OTC DRUG Aller-chlor Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Rugby Laboratories CHLORPHENIRAMINE MALEATE 4 mg/1 0536-1007_a43184c4-d225-4539-b651-4d96535f208f 0536-1007 HUMAN OTC DRUG Rugby Cal-Gest Antacid Assorted Flavors Antacid Tablets TABLET, CHEWABLE ORAL 20140812 OTC MONOGRAPH FINAL part331 Rugby Laboratories, Inc. CALCIUM CARBONATE 500 mg/1 0536-1008_15922349-2825-45d3-95ff-c5a2879ec225 0536-1008 HUMAN OTC DRUG Rugby Aspirin Aspirin TABLET, CHEWABLE ORAL 20140321 OTC MONOGRAPH NOT FINAL part343 Rugby Laboratories ASPIRIN 81 mg/1 0536-1010_1d1911ca-3dea-4f3a-a604-01b8999d9d7e 0536-1010 HUMAN OTC DRUG Diphenhist Diphenhydramine HCl CAPSULE ORAL 20140317 OTC MONOGRAPH FINAL part336 Rugby Laboratories DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0536-1011_7f64a217-9842-4b13-8df1-e62753d1dfe4 0536-1011 HUMAN OTC DRUG Almacone Aluminum hydroxide, Magnesium hydroxide, Simethicone TABLET, CHEWABLE ORAL 20140123 OTC MONOGRAPH FINAL part332 Rugby Laboratories ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 25; 200 mg/1; mg/1; mg/1 0536-1012_418035e3-fbb6-470a-983b-27a1c4d83d31 0536-1012 HUMAN OTC DRUG Earwax Treatment Drops Carbamide Peroxide SOLUTION AURICULAR (OTIC) 20141210 OTC MONOGRAPH FINAL part344 Rugby Laboratories CARBAMIDE PEROXIDE 81.86 mg/mL 0536-1013_67ba2cc8-fb6a-4c5b-bfe2-e755742eabb3 0536-1013 HUMAN OTC DRUG Nasal Relief Oxymetazoline Hydrochloride SPRAY NASAL 20140714 OTC MONOGRAPH FINAL part341 Rugby Laboratories OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL 0536-1015_789949f5-6c8f-4d91-b322-b0ebd4ebed8c 0536-1015 HUMAN OTC DRUG Rugby Acetaminophen 500 mg and Diphenhydramine HCl 25 mg Pain Reliever/Sleep Aid Acetaminophen,Diphenhydramine HCl TABLET, FILM COATED ORAL 20140826 OTC MONOGRAPH NOT FINAL part343 RUGBY LABORATORIES ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 0536-1017_c8f0ee0c-965a-481e-9190-4d706a68f788 0536-1017 HUMAN OTC DRUG Rugby Meclizine HCl, 12.5 mg Each ANTIEMETIC Meclizine HCl TABLET ORAL 20140307 OTC MONOGRAPH FINAL part336 RUGBY LABORATORIES MECLIZINE HYDROCHLORIDE 12.5 mg/1 0536-1018_4d426399-0bea-4a4b-a8a3-c0c34d2bdcc1 0536-1018 HUMAN OTC DRUG Rugby Travel Sickness Meclizine HCl, 25 mg Each (ANTIEMETIC) Meclizine HCl TABLET, CHEWABLE ORAL 20140819 OTC MONOGRAPH FINAL part336 RUGBY LABORATORIES MECLIZINE HYDROCHLORIDE 25 mg/1 0536-1019_a8371dce-cf4c-4300-867f-0d218ea6fc6d 0536-1019 HUMAN OTC DRUG Rugby GAS RELIEF ANTIFLATULENT 80 mg each Simethicone TABLET, CHEWABLE ORAL 20140825 OTC MONOGRAPH FINAL part347 RUGBY LABORATORIES DIMETHICONE 80 mg/1 0536-1021_22a1a88e-6128-49d5-a147-2484186f640b 0536-1021 HUMAN OTC DRUG Peptic Relief Peptic Relief TABLET ORAL 20140220 OTC MONOGRAPH FINAL part335 Rugby Laboratories BISMUTH SUBSALICYLATE 262 mg/1 0536-1022_8b0b968a-70e3-4f6d-af0e-6e78345d4545 0536-1022 HUMAN OTC DRUG All Day Relief Naproxen Sodium, Coated Tablets TABLET ORAL 20140310 ANDA ANDA090545 Rugby Laboratories NAPROXEN SODIUM 220 mg/1 0536-1023_8b0b968a-70e3-4f6d-af0e-6e78345d4545 0536-1023 HUMAN OTC DRUG All Day Relief Naproxen Sodium Tablet, coated TABLET ORAL 20140310 ANDA ANDA090545 Rugby Laboratories NAPROXEN SODIUM 220 mg/1 0536-1024_50ab4f92-e9ac-4b06-89c3-37d521198b55 0536-1024 HUMAN OTC DRUG Rugby Calcium Carbonate 10 gr Antacid Tablets TABLET, CHEWABLE ORAL 20140207 OTC MONOGRAPH FINAL part331 Rugby Laboratories, Inc. CALCIUM CARBONATE 648 mg/1 0536-1025_a33242a3-2b57-4cff-92c5-7c81a33f441b 0536-1025 HUMAN OTC DRUG Aller-chlor Chlorpheniramine Maleate SYRUP ORAL 20140320 OTC MONOGRAPH FINAL part341 Rugby Laboratories CHLORPHENIRAMINE MALEATE 2 mg/5mL 0536-1026_c18413a1-c61d-46d1-bb29-1422c09c015f 0536-1026 HUMAN OTC DRUG Rugby Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20141027 ANDA ANDA078912 Rugby Laboratories GUAIFENESIN 600 mg/1 0536-1034_18349f34-105d-4a2b-9e50-a0353a305fe7 0536-1034 HUMAN OTC DRUG Rugby Heartburn Treatment Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20140505 ANDA ANDA202319 Rugby Laboratories LANSOPRAZOLE 15 mg/1 0536-1038_b7060601-5694-4962-8959-51fb95479ee3 0536-1038 HUMAN OTC DRUG Rugby Nicotine Nicotine Polacrilex LOZENGE ORAL 20141204 ANDA ANDA203690 Rugby Laboratories NICOTINE 2 mg/1 0536-1039_d50395f8-52f1-43a4-b0bd-d6b291655553 0536-1039 HUMAN OTC DRUG rugby nicotine Nicotine Polacrilex LOZENGE ORAL 20141204 ANDA ANDA203690 Rugby Laboratories NICOTINE 4 mg/1 0536-1044_bc89d087-683c-4c9d-b1b5-220a46912e34 0536-1044 HUMAN OTC DRUG Rugby Congestion Relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20141006 ANDA ANDA203200 Rugby Laboratories IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 0536-1045_54fcd3ed-3334-4231-9d0e-ef623b4da257 0536-1045 HUMAN OTC DRUG Sore Throat and Cough benzocaine and dextromethorphan hydrobromide LOZENGE ORAL 20141104 OTC MONOGRAPH NOT FINAL part356 Rugby Laboratories BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 0536-1275_81ce24a5-b01f-435a-bf9a-b3df2cb24d60 0536-1275 HUMAN OTC DRUG Senexon Standardized Senna Concentrate LIQUID ORAL 20121023 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories SENNOSIDES 8.8 mg/5mL 0536-1355_17130da6-b270-4a29-a2aa-ab1afe99dde4 0536-1355 HUMAN OTC DRUG Biscolax Bisacodyl SUPPOSITORY RECTAL 20020903 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories, Inc. BISACODYL 10 mg/1 0536-1362_a3164cb5-575e-4b55-8030-92dcfe567f21 0536-1362 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Mint Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20040729 ANDA ANDA076569 Rugby Laboratories NICOTINE 2 mg/1 0536-1372_a3164cb5-575e-4b55-8030-92dcfe567f21 0536-1372 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Mint Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20040729 ANDA ANDA076568 Rugby Laboratories NICOTINE 4 mg/1 0536-1389_83a3cab3-5629-40af-bf05-c40db0880c8c 0536-1389 HUMAN OTC DRUG Rugby Hemorrhoidal Phenylephrine Hydrochloride and Fat, Hard SUPPOSITORY RECTAL 20010423 OTC MONOGRAPH FINAL part346 Rugby Laboratories, Inc. FAT, HARD; PHENYLEPHRINE HYDROCHLORIDE 1.86; .00525 g/1; g/1 0536-1500_4c5fdd40-46f0-4466-a241-cdda2e0c2899 0536-1500 HUMAN OTC DRUG Reguloid Psyllium CAPSULE ORAL 20100603 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories PSYLLIUM HUSK .52 g/1 0536-1810_306a6ce0-995e-4731-be24-213447448d1f 0536-1810 HUMAN OTC DRUG PINK BISMUTH bismuth subsalicylate LIQUID ORAL 20120401 OTC MONOGRAPH FINAL part335 Rugby Laboratories, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL 0536-1850_93a56296-18f1-40b7-a98d-d2a69ed33faa 0536-1850 HUMAN OTC DRUG Rugby Nasal Decongestant Pseudoephedrine Hydrochloride LIQUID ORAL 19990726 OTC MONOGRAPH FINAL part341 Rugby Laboratories, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5mL 0536-1875_ed2bf69b-8660-4768-886d-dff203fc5c8d 0536-1875 HUMAN OTC DRUG Reguloid Psyllium Husks POWDER, FOR SOLUTION ORAL 20090612 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories PSYLLIUM HUSK 3.4 g/5.8g 0536-1881_e8ea073a-b368-4b52-98b8-6ff2a1eb183c 0536-1881 HUMAN OTC DRUG Reguloid Psyllium POWDER, FOR SOLUTION ORAL 20121029 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories PSYLLIUM HUSK 3.4 g/5g 0536-1945_680c25e0-fa8a-494b-acf7-fa9c23011990 0536-1945 HUMAN OTC DRUG RULOX REGULAR aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110105 OTC MONOGRAPH FINAL part331 Rugby Laboratories, Inc. ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 0536-1962_8555f7dc-82d1-49c1-b68a-69cde8b12b55 0536-1962 HUMAN OTC DRUG Sebex Salicylic Acid, Colloidal Sulfur SHAMPOO TOPICAL 20121029 OTC MONOGRAPH FINAL part333D Rugby Laboratories SALICYLIC ACID; SULFUR 20; 20 mg/1000mL; mg/1000mL 0536-1970_f748f053-ba30-4b5b-acb8-e7d81e72c43e 0536-1970 HUMAN OTC DRUG Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20111007 OTC MONOGRAPH FINAL part349 Rugby Laboratories Inc. POLYVINYL ALCOHOL 14 mg/mL 0536-1995_7dc73cf8-3e47-4b91-8b05-f9ce4a2dd460 0536-1995 HUMAN OTC DRUG Rugby Anti-Dandruff Selenium Sulfide SHAMPOO TOPICAL 20120501 OTC MONOGRAPH FINAL part358H Rugby Laboratories, Inc. SELENIUM SULFIDE 10 mg/mL 0536-2220_5ba43015-528b-4e73-ac31-319efccf6a50 0536-2220 HUMAN OTC DRUG GAS RELIEF Simethicone SUSPENSION/ DROPS ORAL 20101201 OTC MONOGRAPH FINAL part332 Rugby Laboratories, Inc. DIMETHICONE 20 mg/.3mL 0536-2302_a4e2f2f5-533e-4bc5-87ba-80838d193bd5 0536-2302 HUMAN OTC DRUG Blue Gel Pain Relieving Menthol GEL TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part348 Rugby Laboratories MENTHOL .02 g/g 0536-2310_2195c48b-8b48-4853-8c83-ffe0bf26859d 0536-2310 HUMAN OTC DRUG Kidkare cough/cold Chlorpheniramine, Dextromethorphan Hydrobromide, and Pseudoephedrine Hydrochloride LIQUID ORAL 20110113 OTC MONOGRAPH FINAL part341 Rugby Laboratories, Inc. CHLORPHENIRAMINE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 5; 15 mg/5mL; mg/5mL; mg/5mL 0536-2425_020b3d0b-f1fd-42cc-853b-7a4e7dc8351f 0536-2425 HUMAN OTC DRUG Sore Throat Cherry Chloraseptic LIQUID ORAL 20120201 OTC MONOGRAPH NOT FINAL part356 Rugby PHENOL 1.5 g/100mL 0536-2470_66807152-76db-4d5c-9740-114ad61acc54 0536-2470 HUMAN OTC DRUG MILK OF MAGNESIA MINT magnesium hydroxide LIQUID ORAL 20110128 OTC MONOGRAPH FINAL part334 Rugby Laboratories, Inc. MAGNESIUM HYDROXIDE 1200 mg/15mL 0536-2525_9baba6ad-a694-4cf3-b86e-65bffa7d460b 0536-2525 HUMAN OTC DRUG Rugby Capsaicin External Analgesic Capsaicin CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 Rugby Laboratories, Inc. CAPSAICIN .025 g/100g 0536-3000_a5201162-9f58-4d51-8318-68ffd474d961 0536-3000 HUMAN OTC DRUG Ear Wax Treatment Carbamide Peroxide SOLUTION/ DROPS AURICULAR (OTIC) 20091026 OTC MONOGRAPH FINAL part344 Rugby Laboratories Inc. CARBAMIDE PEROXIDE 81.86 mg/mL 0536-3029_ec6f23f7-477d-43ca-9850-ccf90d9d64b2 0536-3029 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Original Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 19990315 ANDA ANDA074507 Rugby Laboratories NICOTINE 2 mg/1 0536-3030_ec6f23f7-477d-43ca-9850-ccf90d9d64b2 0536-3030 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Original Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 19990319 ANDA ANDA074707 Rugby Laboratories NICOTINE 4 mg/1 0536-3086_1f9f38c5-31bd-4254-8fbe-6bd1d5f4a9b5 0536-3086 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20080428 OTC MONOGRAPH FINAL part343 Rugby Laboratories Inc. ASPIRIN 81 mg/1 0536-3112_6aa39382-d33a-4264-a12e-ca93f60e359b 0536-3112 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Coated Mint Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20081229 ANDA ANDA078699 Rugby Laboratories NICOTINE 2 mg/1 0536-3113_6aa39382-d33a-4264-a12e-ca93f60e359b 0536-3113 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Coated Mint Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20081229 ANDA ANDA078697 Rugby Laboratories NICOTINE 4 mg/1 0536-3218_1edaba94-ae15-4a64-a947-05ff594577a7 0536-3218 HUMAN OTC DRUG Pain and Fever ACETAMINOPHEN TABLET, COATED ORAL 20110223 OTC MONOGRAPH FINAL part343 RUGBY LABORATORIES, INC. ACETAMINOPHEN 500 mg/1 0536-3222_9ad8d1ec-7c94-4573-a0fa-295d66a3e8c9 0536-3222 HUMAN OTC DRUG Pain and Fever ACETAMINOPHEN TABLET ORAL 20110223 OTC MONOGRAPH FINAL part343 RUGBY LABORATORIES, INC. ACETAMINOPHEN 325 mg/1 0536-3231_c5880f2a-0e00-43c2-9420-ee58368f82f7 0536-3231 HUMAN OTC DRUG Pain and Fever ACETAMINOPHEN TABLET ORAL 20110223 OTC MONOGRAPH FINAL part343 RUGBY LABORATORIES, INC. ACETAMINOPHEN 500 mg/1 0536-3233_e27f3e6e-9692-4775-b5d9-fc686919af50 0536-3233 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20020812 OTC MONOGRAPH FINAL part343 Rugby Laboratories Inc. ACETAMINOPHEN 80 mg/1 0536-3297_cb1c37d3-f4a3-4733-bb24-63c835f0c940 0536-3297 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19980123 OTC MONOGRAPH FINAL part343 Rugby Laboratories Inc. ASPIRIN 81 mg/1 0536-3305_d23ea51a-b3ca-432a-b060-33f96a570488 0536-3305 HUMAN OTC DRUG Micro-Coated Aspirin Aspirin TABLET, COATED ORAL 20110921 OTC MONOGRAPH FINAL part343 Rugby Laboratories, Inc ASPIRIN 325 mg/1 0536-3313_92e6edd3-1afe-4223-a2a8-fd538088c718 0536-3313 HUMAN OTC DRUG Enteric Coated Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20110920 OTC MONOGRAPH FINAL part343 Rugby Laboratories, Inc ASPIRIN 325 mg/1 0536-3381_28a65991-a53d-4e04-8253-9a9d0c49bf57 0536-3381 HUMAN OTC DRUG Enteric Coated Stimulant Laxative Bisacodyl TABLET, DELAYED RELEASE ORAL 20110922 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories, Inc BISACODYL 5 mg/1 0536-3386_cb27282f-f7f5-4cac-aee0-73fee71c4617 0536-3386 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20090708 ANDA ANDA079044 Rugby Laboratories NICOTINE 2 mg/1 0536-3387_cb27282f-f7f5-4cac-aee0-73fee71c4617 0536-3387 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20090708 ANDA ANDA079038 Rugby Laboratories NICOTINE 4 mg/1 0536-3404_68549a11-d195-4e8c-b61b-c6c86db4355e 0536-3404 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Coated Cinnamon Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20090708 ANDA ANDA079216 Rugby Laboratories NICOTINE 2 mg/1 0536-3405_68549a11-d195-4e8c-b61b-c6c86db4355e 0536-3405 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Coated Cinnamon Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20090708 ANDA ANDA079219 Rugby Laboratories NICOTINE 4 mg/1 0536-3414_072d6298-0d2b-476e-bb53-eee6dac12127 0536-3414 HUMAN OTC DRUG Calcium carbonate Calcium carbonate TABLET ORAL 19990412 OTC MONOGRAPH FINAL part331 Rugby Laboratories Inc. CALCIUM CARBONATE 648 mg/1 0536-3467_8000b4af-e604-4aa5-b62a-66c902a934ad 0536-3467 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET ORAL 20000530 OTC MONOGRAPH FINAL part341 Rugby Laboratories Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 0536-3479_74cea4c6-8712-428c-96af-dd9d85c77962 0536-3479 HUMAN OTC DRUG Acetaminophen and Diphenhydramine HCl Acetaminophen and Diphenhydramine HCl TABLET ORAL 20101006 OTC MONOGRAPH FINAL part343 Rugby Laboratories Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 0536-3504_9830a852-c0a7-4ac9-9848-4cf86dd07013 0536-3504 HUMAN OTC DRUG Almacone Aluminum hydroxide, Magnesium hydroxide, Simethicone TABLET, CHEWABLE ORAL 20100823 OTC MONOGRAPH FINAL part332 Rugby Laboratories, Inc. ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/1; mg/1; mg/1 0536-3587_3cb379dd-b4d5-4f2f-9da9-c11979317cd3 0536-3587 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20110301 ANDA ANDA079174 Rugby Laboratories Inc IBUPROFEN 200 mg/1 0536-3594_b77e622c-70c1-4360-b360-8aca012cd838 0536-3594 HUMAN OTC DRUG Diphenhist Diphenhydramine HCl CAPSULE ORAL 20060530 OTC MONOGRAPH FINAL part341 Rugby Laboratories Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0536-3597_f95ca994-1117-4c92-adf1-3f6825d7bf5f 0536-3597 HUMAN OTC DRUG Diphenhist Diphenhydramine HCl TABLET ORAL 20060926 OTC MONOGRAPH FINAL part341 Rugby Laboratories Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0536-3603_a9e31638-7a95-4173-b204-daed7aa0f700 0536-3603 HUMAN OTC DRUG Ibuprofen IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20120326 ANDA ANDA078682 Rugby Laboratories, Inc. IBUPROFEN 200 mg/1 0536-3604_ccbb04cd-d46a-439e-ad65-e3f99e75ea67 0536-3604 HUMAN OTC DRUG Simethicone Simethicone CAPSULE, LIQUID FILLED ORAL 20120509 OTC MONOGRAPH FINAL part332 Rugby Laboratories, Inc. DIMETHICONE 180 mg/1 0536-3605_411070bc-dca5-4c0a-a574-7d098c0cbefd 0536-3605 HUMAN OTC DRUG Acetaminophen and Diphenhydramine HCl Acetagesic TABLET ORAL 20120612 OTC MONOGRAPH FINAL part343 Rugby Laboratories Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 325; 12.5 mg/1; mg/1 0536-3606_dcc96e3c-af6c-4a02-98a1-9568349c8f6d 0536-3606 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen Acetaminophen SUSPENSION ORAL 20120824 OTC MONOGRAPH FINAL part343 Rugby ACETAMINOPHEN 160 mg/5mL 0536-3607_6092834e-e183-4146-9780-dd5429893d10 0536-3607 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET ORAL 20121029 OTC MONOGRAPH FINAL part341 Rugby Laboratories PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 0536-3755_7f7f83e2-b04d-44d0-84cb-f2a85cac8e35 0536-3755 HUMAN OTC DRUG Stool Softener DC Laxative DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20111201 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories Inc DOCUSATE CALCIUM 240 mg/1 0536-3756_ab17427e-4079-4c76-91f9-53af9b508b7e 0536-3756 HUMAN OTC DRUG Non-Habit Forming Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120329 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories Inc DOCUSATE SODIUM 100 mg/1 0536-3757_291d6bae-4c24-4ead-b075-0a671f905ed4 0536-3757 HUMAN OTC DRUG EXTRA STRENGTH STOOL SOFTENER LAXATIVE DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120329 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories Inc DOCUSATE SODIUM 250 mg/1 0536-3772_08ece8f0-64f9-4738-9423-2e7b2ca420ee 0536-3772 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl TABLET ORAL 20070713 OTC MONOGRAPH FINAL part341 Rugby Laboratories Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 0536-3985_746b935f-de20-4070-af96-aacc71f44079 0536-3985 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20060714 OTC MONOGRAPH FINAL part336 Rugby Laboratories Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 0536-3990_c500c05e-d501-4e0a-b01d-c0223ae05191 0536-3990 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20080722 OTC MONOGRAPH FINAL part336 Rugby Laboratories Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 0536-4086_e6f3e8a2-567b-495f-832a-c7c8ae1f7ba9 0536-4086 HUMAN OTC DRUG SENEXON-S DOCUSATE SODIUM -SENNOSIDES TABLET, COATED ORAL 20110316 OTC MONOGRAPH NOT FINAL part334 RUGBY LABORATORIES, INC. DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 0536-4088_44912f39-94c7-455c-b756-0e874f4598b7 0536-4088 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine TABLET ORAL 20120323 ANDA ANDA078780 Rugby Laboratories Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 0536-4089_f3c1bcd1-625f-4a8f-807e-9d46edd216b0 0536-4089 HUMAN OTC DRUG Acne Medication 5 Benzoyl Peroxide GEL TOPICAL 20121029 OTC MONOGRAPH FINAL part333D Rugby Laboratories BENZOYL PEROXIDE 50 mg/g 0536-4092_03b94e6c-f864-48ad-94c1-f08ddc2c2de0 0536-4092 HUMAN OTC DRUG Acne Medication 10 Benzoyl Peroxide GEL TOPICAL 20121029 OTC MONOGRAPH FINAL part333D Rugby Laboratories BENZOYL PEROXIDE 100 mg/g 0536-4113_2d53fc65-83b2-4cc0-aa31-1b35bd26ea62 0536-4113 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20091125 ANDA ANDA079096 Rugby Laboratories Inc NAPROXEN SODIUM 220 mg/1 0536-4122_702120d6-f2ce-4e95-b529-cd4da09c5ed3 0536-4122 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202727 Rugby Laboratories Inc LANSOPRAZOLE 15 mg/1 0536-4301_22b0e4d5-985d-4ba4-a028-9883c069d01f 0536-4301 HUMAN OTC DRUG Bismuth subsalicylate Bismuth subsalicylate TABLET ORAL 19960123 OTC MONOGRAPH FINAL part335 Rugby Laboratories Inc. BISMUTH SUBSALICYLATE 262 mg/1 0536-4306_e691924b-76e8-4339-8f2e-faa2caf14e47 0536-4306 HUMAN OTC DRUG Fiber Lax Calcium Polycarbophil TABLET, FILM COATED ORAL 20100901 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories CALCIUM POLYCARBOPHIL 625 mg/1 0536-4391_26ba1486-871c-47fa-9790-328a9d3bdf5d 0536-4391 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET, SUGAR COATED ORAL 20110922 OTC MONOGRAPH FINAL part341 Rugby Laboratories, Inc PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 0536-4444_9915efdf-c585-49d0-b993-3d69c8c7e613 0536-4444 HUMAN OTC DRUG Reguloid Psyllium POWDER, FOR SOLUTION ORAL 20121029 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories PSYLLIUM HUSK 3.4 g/7g 0536-4445_b70a440d-b4e7-4fd1-9319-430ab2294fa4 0536-4445 HUMAN OTC DRUG Reguloid Psyllium POWDER, FOR SOLUTION ORAL 20090622 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories PSYLLIUM HUSK 3.4 g/12g 0536-4533_30e4ab62-a058-4dc8-ac41-a45b5c8dc59c 0536-4533 HUMAN OTC DRUG Gas Relief Simethicone TABLET, CHEWABLE ORAL 19950101 OTC MONOGRAPH FINAL part332 Rugby Laboratories Inc. DIMETHICONE 80 mg/1 0536-4534_e76fb40a-e9df-4267-9529-635516390eb7 0536-4534 HUMAN OTC DRUG Gas Relief Simethicone TABLET, CHEWABLE ORAL 19951016 OTC MONOGRAPH FINAL part332 Rugby Laboratories Inc. DIMETHICONE 125 mg/1 0536-4540_2f621fcf-b08c-4e0a-8a15-11a1894d7b1f 0536-4540 HUMAN OTC DRUG Sodium Bicarbonate Sodium Bicarbonate TABLET ORAL 20100421 OTC MONOGRAPH FINAL part331 Rugby Laboratories, Inc. SODIUM BICARBONATE 325 mg/1 0536-4544_d8850588-2337-462e-bc3b-c94d82792284 0536-4544 HUMAN OTC DRUG Sodium Bicarbonate Sodium Bicarbonate TABLET ORAL 20100308 OTC MONOGRAPH FINAL part331 Rugby Laboratories, Inc. SODIUM BICARBONATE 650 mg/1 0536-4742_654ee499-29b8-464e-8190-459cf75d25ab 0536-4742 HUMAN OTC DRUG Calgest Calgest TABLET ORAL 19960123 OTC MONOGRAPH FINAL part331 Rugby Laboratories Inc. CALCIUM CARBONATE 500 mg/1 0536-5005_bad09514-ea1b-4d6d-8489-8898136037ce 0536-5005 HUMAN OTC DRUG Nasal Relief 12-Hour Oxymetazoline Hydrochloride SPRAY NASAL 20121029 OTC MONOGRAPH FINAL part341 Rugby Laboratories OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 0536-5105_b92989a1-d34d-46cf-bb22-1ac92bd209b5 0536-5105 HUMAN OTC DRUG Hydro Skin HYDROCORTISONE LOTION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part348 Rugby Laboratories HYDROCORTISONE 1 g/mL 0536-5108_3143369a-e265-4bf0-86c4-5e2b43f75b85 0536-5108 HUMAN OTC DRUG HydroSkin Hydrocortisone CREAM TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part348 Rugby Laboratories HYDROCORTISONE 1 g/100g 0536-5150_8b376e99-261c-4df0-9b81-ffc4dba081e6 0536-5150 HUMAN OTC DRUG Anti-Fungal TOLNAFTATE POWDER TOPICAL 20111101 OTC MONOGRAPH FINAL part333C Rugby Laboratories TOLNAFTATE .45 g/45g 0536-5700_01586357-6c74-4180-96a4-9a78840f6f2f 0536-5700 HUMAN OTC DRUG Rugby Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20040323 OTC MONOGRAPH FINAL part347 Rugby Laboratories ZINC OXIDE 200 mg/g 0536-5894_f159d388-fffe-429e-a219-aa95b5ba033f 0536-5894 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 19971020 ANDA ANDA074612 Rugby Laboratories NICOTINE 7 mg/24h 0536-5895_d4af89ac-04da-40d1-a1c2-3b08b1ae59d4 0536-5895 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 19971020 ANDA ANDA074612 Rugby Laboratories NICOTINE 14 mg/24h 0536-5896_e5558f2a-905d-4839-b908-94191604ff8e 0536-5896 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 19971020 ANDA ANDA074612 Rugby Laboratories NICOTINE 21 mg/24h 0536-5904_186d75c7-7b10-464d-a94d-f48d12db4c0b 0536-5904 HUMAN OTC DRUG SENEXON SENNA TABLET, COATED ORAL 20060209 OTC MONOGRAPH NOT FINAL part334 RUGBY LABORATORIES, INC. SENNOSIDES A AND B 8.6 mg/1 0536-6237_3bb70d72-f763-4486-8f6a-d37ece21292b 0536-6237 HUMAN OTC DRUG Natures Tears Hypromellose SOLUTION/ DROPS OPHTHALMIC 20111007 OTC MONOGRAPH FINAL part349 Rugby Laboratories Inc. HYPROMELLOSE 2910 (3 MPA.S) 4 mg/mL 0536-6550_71876336-83de-4baa-a82d-4b056b41bbeb 0536-6550 HUMAN OTC DRUG Artificial Tears white petrolatum mineral oil OINTMENT OPHTHALMIC 20111007 OTC MONOGRAPH FINAL part349 Rugby Laboratories Inc. MINERAL OIL; PETROLATUM 150; 830 mg/g; mg/g 0536-7415_a2797325-b60b-4e79-a866-cf5a710baa28 0536-7415 HUMAN OTC DRUG Ready-to-Use Sodium Phosphate ENEMA RECTAL 20110901 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories, Inc. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 0548-1140_a20da7f1-87db-469c-90de-9b9fdabbdb40 0548-1140 HUMAN PRESCRIPTION DRUG Phytonadione Phytonadione INJECTION, EMULSION PARENTERAL 19880324 ANDA ANDA083722 Amphastar Pharmaceuticals, Inc. PHYTONADIONE 1 mg/.5mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 0548-1240_4c6e84de-e87a-407a-8e25-c158b3c5ce99 0548-1240 HUMAN PRESCRIPTION DRUG Phytonadione Phytonadione INJECTION, EMULSION PARENTERAL 20030418 ANDA ANDA083722 Amphastar Pharmaceuticals, Inc. PHYTONADIONE 1 mg/.5mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 0548-1469_19750aa4-d28a-437a-9b99-8ccd82137d8d 0548-1469 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION PARENTERAL 19880401 ANDA ANDA072076 Amphastar Pharmaceuticals, Inc. NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 0548-1911_a8afdf64-6ed1-43ac-91e8-22d2bad3768b 0548-1911 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19870327 UNAPPROVED DRUG OTHER Amphastar Pharmaceuticals, Inc. MORPHINE SULFATE 30 mg/30mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0548-3011_d9168a3e-abe4-4120-bde3-f968af317157 0548-3011 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 Amphastar Pharmaceuticals, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0548-3012_d9168a3e-abe4-4120-bde3-f968af317157 0548-3012 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 Amphastar Pharmaceuticals, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0548-3013_d9168a3e-abe4-4120-bde3-f968af317157 0548-3013 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 Amphastar Pharmaceuticals, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0548-3015_d9168a3e-abe4-4120-bde3-f968af317157 0548-3015 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 Amphastar Pharmaceuticals, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0548-3301_7a8088b4-be7f-457e-8421-9af36844bd13 0548-3301 HUMAN PRESCRIPTION DRUG Dextrose Monohydrate Dextrose Monohydrate INJECTION PARENTERAL 20000601 UNAPPROVED DRUG OTHER Amphastar Pharmaceuticals, Inc. DEXTROSE MONOHYDRATE 500 mg/mL 0548-3304_37203471-df31-4230-a3c1-4825a8d909d4 0548-3304 HUMAN PRESCRIPTION DRUG Calcium Chloride Calcium Chloride INJECTION PARENTERAL 20000601 UNAPPROVED DRUG OTHER Amphastar Pharmaceuticals, Inc. CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0548-3316_7b3e43ae-0b95-407c-a269-650b57dec42d 0548-3316 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION PARENTERAL 20100825 UNAPPROVED DRUG OTHER Amphastar Pharmaceuticals, Inc. EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0548-3339_baf8e070-0519-4e50-ac2d-61f5752cc534 0548-3339 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION PARENTERAL 19900102 UNAPPROVED DRUG OTHER Amphastar Pharmaceuticals, Inc. ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0548-3352_4dc1f73b-d2c0-4b0e-99d2-919e7bdef116 0548-3352 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION PARENTERAL 20000601 UNAPPROVED DRUG OTHER Amphastar Pharmaceuticals, Inc. SODIUM BICARBONATE 84 mg/mL 0548-3369_19750aa4-d28a-437a-9b99-8ccd82137d8d 0548-3369 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION PARENTERAL 20010601 ANDA ANDA072076 Amphastar Pharmaceuticals, Inc. NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 0548-3390_f9b77f7a-e3bc-412b-bc46-f29c9126a0e5 0548-3390 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION PARENTERAL 20010601 ANDA ANDA083173 Amphastar Pharmaceuticals, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0548-3391_a8afdf64-6ed1-43ac-91e8-22d2bad3768b 0548-3391 HUMAN PRESCRIPTION DRUG Morphine Sulfate morphine sulfate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20000811 UNAPPROVED DRUG OTHER Amphastar Pharmaceuticals, Inc. MORPHINE SULFATE 10 mg/10mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0548-5601_5366f3fa-5bf8-43bd-9490-103cf23eaf20 0548-5601 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0548-5602_5366f3fa-5bf8-43bd-9490-103cf23eaf20 0548-5602 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0548-5603_5366f3fa-5bf8-43bd-9490-103cf23eaf20 0548-5603 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0548-5604_5366f3fa-5bf8-43bd-9490-103cf23eaf20 0548-5604 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0548-5605_5366f3fa-5bf8-43bd-9490-103cf23eaf20 0548-5605 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0548-5606_5366f3fa-5bf8-43bd-9490-103cf23eaf20 0548-5606 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0548-5607_5366f3fa-5bf8-43bd-9490-103cf23eaf20 0548-5607 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0548-5631_2979830b-c1e5-4061-9eb9-50bfa135c49a 0548-5631 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0548-5632_2979830b-c1e5-4061-9eb9-50bfa135c49a 0548-5632 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0548-5633_2979830b-c1e5-4061-9eb9-50bfa135c49a 0548-5633 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0548-5634_2979830b-c1e5-4061-9eb9-50bfa135c49a 0548-5634 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0548-5635_2979830b-c1e5-4061-9eb9-50bfa135c49a 0548-5635 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0548-5636_2979830b-c1e5-4061-9eb9-50bfa135c49a 0548-5636 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0548-5637_2979830b-c1e5-4061-9eb9-50bfa135c49a 0548-5637 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0548-5900_b48eb5b6-b611-456a-8a78-b1f78256e477 0548-5900 HUMAN PRESCRIPTION DRUG Cortrosyn Cosyntropin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20030801 NDA NDA016750 Amphastar Pharmaceuticals, Inc. COSYNTROPIN .25 mg/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] 0548-6300_aaadace4-ffb5-44ad-8fe1-3550917577f1 0548-6300 HUMAN PRESCRIPTION DRUG Laryng-O-Jet Lidocaine Hydrochloride SOLUTION TOPICAL 19800306 ANDA ANDA086364 Amphastar Pharmaceuticals, Inc. LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0548-9061_e3ddcb69-a23e-4b26-af06-44caddcbc442 0548-9061 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION PARENTERAL 20000701 UNAPPROVED DRUG OTHER Amphastar Pharmaceuticals, Inc. EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0548-9090_e8549939-d712-4d4c-8e18-4b9d3c6ea7d2 0548-9090 HUMAN PRESCRIPTION DRUG AMPHADASE hyaluronidase INJECTION SUBCUTANEOUS 20041026 NDA NDA021665 Amphastar Pharmaceuticals, Inc. HYALURONIDASE 150 [USP'U]/mL Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient] 0555-0033_7ab6c05a-8236-46c8-a555-eaf06674f669 0555-0033 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19900930 ANDA ANDA083116 Barr Laboratories Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0555-0066_e52d3ab7-6583-4026-b79e-7cf9c50617cb 0555-0066 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080936 Barr Laboratories Inc. ISONIAZID 100 mg/1 Antimycobacterial [EPC] 0555-0071_e52d3ab7-6583-4026-b79e-7cf9c50617cb 0555-0071 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080937 Barr Laboratories Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] 0555-0094_b898d6f1-a2db-49a4-b80d-2deabf0c3772 0555-0094 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050810 ANDA ANDA077194 Barr Laboratories Inc. CLONAZEPAM .125 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0555-0095_b898d6f1-a2db-49a4-b80d-2deabf0c3772 0555-0095 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050810 ANDA ANDA077194 Barr Laboratories Inc. CLONAZEPAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0555-0096_b898d6f1-a2db-49a4-b80d-2deabf0c3772 0555-0096 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050811 ANDA ANDA077194 Barr Laboratories Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0555-0097_b898d6f1-a2db-49a4-b80d-2deabf0c3772 0555-0097 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050811 ANDA ANDA077194 Barr Laboratories Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0555-0098_b898d6f1-a2db-49a4-b80d-2deabf0c3772 0555-0098 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050811 ANDA ANDA077194 Barr Laboratories Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0555-0138_5fd5061f-3f9b-4c74-b2f7-f9b4b92826c0 0555-0138 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20080828 ANDA ANDA077605 Barr Laboratories Inc. GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0555-0139_5fd5061f-3f9b-4c74-b2f7-f9b4b92826c0 0555-0139 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20080828 ANDA ANDA077605 Barr Laboratories Inc. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0555-0140_5fd5061f-3f9b-4c74-b2f7-f9b4b92826c0 0555-0140 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20080828 ANDA ANDA077605 Barr Laboratories Inc. GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0555-0158_7ab6c05a-8236-46c8-a555-eaf06674f669 0555-0158 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19760701 ANDA ANDA084768 Barr Laboratories Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0555-0159_7ab6c05a-8236-46c8-a555-eaf06674f669 0555-0159 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19760702 ANDA ANDA084769 Barr Laboratories Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0555-0171_ce9bdedb-865d-4403-967b-da65d7f37b70 0555-0171 HUMAN PRESCRIPTION DRUG Mefloquine Hydrochloride Mefloquine Hydrochloride TABLET ORAL 20040106 ANDA ANDA076392 Barr Laboratories Inc. MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC] 0555-0211_1c9b90cc-fb18-415e-b9b3-ca710413016c 0555-0211 HUMAN PRESCRIPTION DRUG Norethindrone Acetate Norethindrone Acetate TABLET ORAL 20010629 ANDA ANDA075951 Barr Laboratories Inc. NORETHINDRONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0555-0252_4be61c39-5cde-4333-9475-0f29020d5d02 0555-0252 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 19801001 ANDA ANDA087184 Barr Laboratories Inc. DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0555-0285_4be61c39-5cde-4333-9475-0f29020d5d02 0555-0285 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 19820101 ANDA ANDA087716 Barr Laboratories Inc. DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0555-0286_4be61c39-5cde-4333-9475-0f29020d5d02 0555-0286 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 19820101 ANDA ANDA087717 Barr Laboratories Inc. DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0555-0302_28bfea9f-c840-4a16-a127-56c72c27f38e 0555-0302 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19840701 ANDA ANDA088487 Barr Laboratories Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0555-0323_28bfea9f-c840-4a16-a127-56c72c27f38e 0555-0323 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19840701 ANDA ANDA088496 Barr Laboratories Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0555-0324_28bfea9f-c840-4a16-a127-56c72c27f38e 0555-0324 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19840701 ANDA ANDA088488 Barr Laboratories Inc. HYDROXYZINE PAMOATE 100 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0555-0344_5434054e-77e4-4bdc-952e-6847127458b1 0555-0344 HUMAN PRESCRIPTION DRUG Errin Norethindrone TABLET ORAL 20030108 ANDA ANDA076225 Barr Laboratories Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0555-0381_713fe2cc-7b40-44f2-a9fd-d25aa331bbbc 0555-0381 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 19970203 ANDA ANDA088639 Barr Laboratories Inc. MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0555-0382_ce01b36b-f5dd-43f2-8d23-1a35425054e6 0555-0382 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 19961011 20160731 ANDA ANDA088640 Barr Laboratories Inc. MEPERIDINE HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0555-0392_713fe2cc-7b40-44f2-a9fd-d25aa331bbbc 0555-0392 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 19961011 ANDA ANDA088640 Barr Laboratories Inc. MEPERIDINE HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0555-0483_4b7471b7-1883-45f2-b270-c5f7d5c9a302 0555-0483 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride and Hydrochlorothiazide Amiloride Hydrochloride and Hydrochlorothiazide TABLET ORAL 19891201 ANDA ANDA071111 Barr Laboratories Inc. AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0555-0484_92d0bb3e-0574-4ccb-99ec-66ec4dc39c27 0555-0484 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19900630 ANDA ANDA071198 Barr Laboratories Inc. LEUCOVORIN CALCIUM 5 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 0555-0485_92d0bb3e-0574-4ccb-99ec-66ec4dc39c27 0555-0485 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19900630 ANDA ANDA071199 Barr Laboratories Inc. LEUCOVORIN CALCIUM 25 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 0555-0513_9a0497ce-5c25-40ed-9e61-3a46940a71f0 0555-0513 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide CAPSULE, EXTENDED RELEASE ORAL 20000222 NDA NDA012945 Barr Laboratories Inc.. ACETAZOLAMIDE 500 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 0555-0572_cd002dc0-f02b-4f98-8f27-c84005ee8d8a 0555-0572 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate TABLET ORAL 19901101 ANDA ANDA081099 Barr Laboratories Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0555-0588_45b4da17-db8a-4c06-a10b-f9274dc5c9a4 0555-0588 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE PELLETS ORAL 20041215 ANDA ANDA077167 Barr Laboratories Inc. DIDANOSINE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0555-0589_45b4da17-db8a-4c06-a10b-f9274dc5c9a4 0555-0589 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE PELLETS ORAL 20041215 ANDA ANDA077167 Barr Laboratories Inc. DIDANOSINE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0555-0590_45b4da17-db8a-4c06-a10b-f9274dc5c9a4 0555-0590 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE PELLETS ORAL 20041215 ANDA ANDA077167 Barr Laboratories Inc. DIDANOSINE 400 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 0555-0594_17c70468-0a6f-4510-a5c1-9d6ac564819b 0555-0594 HUMAN PRESCRIPTION DRUG Protriptyline Hydrochloride Protriptyline Hydrochloride TABLET, FILM COATED ORAL 20081223 ANDA ANDA073645 Barr Laboratories Inc. PROTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0555-0595_17c70468-0a6f-4510-a5c1-9d6ac564819b 0555-0595 HUMAN PRESCRIPTION DRUG Protriptyline Hydrochloride Protriptyline Hydrochloride TABLET, FILM COATED ORAL 20081223 ANDA ANDA073644 Barr Laboratories Inc. PROTRIPTYLINE HYDROCHLORIDE 5 mg/1 Tricyclic Antidepressant [EPC] 0555-0606_95aab0c8-051c-48ad-9b14-89572e2f4884 0555-0606 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19961025 ANDA ANDA074621 Barr Laboratories Inc. MEGESTROL ACETATE 20 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0555-0607_95aab0c8-051c-48ad-9b14-89572e2f4884 0555-0607 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19951130 ANDA ANDA074621 Barr Laboratories Inc. MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0555-0633_493fa059-0dc2-437f-a738-b7e40091ed5d 0555-0633 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 19980625 ANDA ANDA074582 Barr Laboratories Inc. DANAZOL 50 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 0555-0634_493fa059-0dc2-437f-a738-b7e40091ed5d 0555-0634 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 19980625 ANDA ANDA074582 Barr Laboratories Inc. DANAZOL 100 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 0555-0635_493fa059-0dc2-437f-a738-b7e40091ed5d 0555-0635 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 19960809 ANDA ANDA074582 Barr Laboratories Inc. DANAZOL 200 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 0555-0658_18cb66f6-f17f-446a-82f8-6c09b32b29ff 0555-0658 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen CAPSULE ORAL 19990520 20160229 ANDA ANDA040289 Barr Laboratories Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0555-0701_f149ef1c-0ec8-45d6-9b56-fe6108d0ac4d 0555-0701 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET, FILM COATED ORAL 20050104 ANDA ANDA065171 Barr Laboratories Inc. DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 0555-0702_f149ef1c-0ec8-45d6-9b56-fe6108d0ac4d 0555-0702 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET, FILM COATED ORAL 20050104 ANDA ANDA065171 Barr Laboratories Inc. DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 0555-0715_7d9c5345-a2b4-4f48-9e75-61ef21a80aac 0555-0715 HUMAN PRESCRIPTION DRUG Camila Norethindrone TABLET ORAL 20021030 ANDA ANDA076177 Barr Laboratories Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0555-0733_b2ee236d-5b27-40a7-893f-345b0b42146a 0555-0733 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19990503 ANDA ANDA071196 Barr Laboratories Inc. TRAZODONE HYDROCHLORIDE 300 mg/1 Serotonin Reuptake Inhibitor [EPC] 0555-0762_7ad6983d-1e30-450e-8122-26418ae6efed 0555-0762 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20080811 20150831 ANDA ANDA040422 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0763_7ad6983d-1e30-450e-8122-26418ae6efed 0555-0763 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20080811 20150731 ANDA ANDA040422 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0764_7ad6983d-1e30-450e-8122-26418ae6efed 0555-0764 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20080811 20150531 ANDA ANDA040422 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0765_7ad6983d-1e30-450e-8122-26418ae6efed 0555-0765 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20080811 20150331 ANDA ANDA040422 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0766_7ad6983d-1e30-450e-8122-26418ae6efed 0555-0766 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20080811 20150430 ANDA ANDA040422 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0767_7ad6983d-1e30-450e-8122-26418ae6efed 0555-0767 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20080811 20150731 ANDA ANDA040422 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0768_7ad6983d-1e30-450e-8122-26418ae6efed 0555-0768 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20080811 20150731 ANDA ANDA040422 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0775_a7ba6926-fcb6-4406-919c-290f2357934f 0555-0775 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20030319 ANDA ANDA040422 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0776_a7ba6926-fcb6-4406-919c-290f2357934f 0555-0776 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20030319 ANDA ANDA040422 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0777_a7ba6926-fcb6-4406-919c-290f2357934f 0555-0777 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20030319 ANDA ANDA040422 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0778_f8107ea5-6eef-4984-81eb-de3f7dc774f2 0555-0778 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride and Ibuprofen Oxycodone Hydrochloride and Ibuprofen TABLET, FILM COATED ORAL 20071204 ANDA ANDA078316 Barr Laboratories Inc. IBUPROFEN; OXYCODONE HYDROCHLORIDE 400; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 0555-0779_b5c4f918-796b-4542-976f-8166f3375771 0555-0779 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 Barr Laboratories Inc. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0555-0787_b4d19876-6df7-4a0a-acb6-0083fbaf6d3d 0555-0787 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0788_b4d19876-6df7-4a0a-acb6-0083fbaf6d3d 0555-0788 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0789_b4d19876-6df7-4a0a-acb6-0083fbaf6d3d 0555-0789 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0790_b4d19876-6df7-4a0a-acb6-0083fbaf6d3d 0555-0790 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0791_b4d19876-6df7-4a0a-acb6-0083fbaf6d3d 0555-0791 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0792_b4d19876-6df7-4a0a-acb6-0083fbaf6d3d 0555-0792 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0808_394ef3ed-b93e-49d1-a9fa-1781f9f77019 0555-0808 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CAPSULE ORAL 20070626 ANDA ANDA077684 Barr Laboratories Inc. TRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 0555-0831_5c275080-0a7d-40cb-9c7c-2b04e830a1e1 0555-0831 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 ANDA ANDA040145 Barr Laboratories Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0555-0832_5c275080-0a7d-40cb-9c7c-2b04e830a1e1 0555-0832 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 ANDA ANDA040145 Barr Laboratories Inc. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0555-0833_5c275080-0a7d-40cb-9c7c-2b04e830a1e1 0555-0833 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 ANDA ANDA040145 Barr Laboratories Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0555-0834_5c275080-0a7d-40cb-9c7c-2b04e830a1e1 0555-0834 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 ANDA ANDA040145 Barr Laboratories Inc. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0555-0835_5c275080-0a7d-40cb-9c7c-2b04e830a1e1 0555-0835 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 ANDA ANDA040145 Barr Laboratories Inc. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0555-0859_229f867f-d9cf-4298-bb19-dfb874fb5035 0555-0859 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20021118 ANDA ANDA075882 Barr Laboratories Inc. FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] 0555-0860_229f867f-d9cf-4298-bb19-dfb874fb5035 0555-0860 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20021119 ANDA ANDA075882 Barr Laboratories Inc. FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] 0555-0861_229f867f-d9cf-4298-bb19-dfb874fb5035 0555-0861 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20021119 ANDA ANDA075882 Barr Laboratories Inc. FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] 0555-0869_5c275080-0a7d-40cb-9c7c-2b04e830a1e1 0555-0869 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 ANDA ANDA040145 Barr Laboratories Inc. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0555-0872_b5c4f918-796b-4542-976f-8166f3375771 0555-0872 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 Barr Laboratories Inc. MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0555-0873_b5c4f918-796b-4542-976f-8166f3375771 0555-0873 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961203 ANDA ANDA040159 Barr Laboratories Inc. MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0555-0874_5c275080-0a7d-40cb-9c7c-2b04e830a1e1 0555-0874 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 ANDA ANDA040145 Barr Laboratories Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0555-0877_1431e6ed-9e7b-4c10-9489-717c57f90d11 0555-0877 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine hydrochloride CAPSULE ORAL 20010802 ANDA ANDA074803 Barr Laboratories Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0555-0882_97cb0c06-808d-4638-a9ae-c958d8ba778f 0555-0882 HUMAN PRESCRIPTION DRUG HYDROXYUREA Hydroxyurea CAPSULE ORAL 19981019 ANDA ANDA075143 Barr Laboratories Inc. HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] 0555-0886_51f30bee-1653-4b61-bc3e-086106e144b4 0555-0886 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 Barr Laboratories Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0555-0887_51f30bee-1653-4b61-bc3e-086106e144b4 0555-0887 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 Barr Laboratories Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0555-0899_51f30bee-1653-4b61-bc3e-086106e144b4 0555-0899 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 Barr Laboratories Inc. ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0555-0902_d3778189-a2c3-4a10-939a-dbc1d3df9499 0555-0902 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 19980508 ANDA ANDA074918 Barr Laboratories Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] 0555-0923_6259f2b6-7a35-4a11-b5ab-b5d3df19ae84 0555-0923 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET, FILM COATED ORAL 20011127 ANDA ANDA076057 Barr Laboratories Inc. ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] 0555-0925_5c275080-0a7d-40cb-9c7c-2b04e830a1e1 0555-0925 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19981112 ANDA ANDA040145 Barr Laboratories Inc. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0555-0926_5c275080-0a7d-40cb-9c7c-2b04e830a1e1 0555-0926 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19981116 ANDA ANDA040145 Barr Laboratories Inc. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0555-0952_c8ac3d3d-4961-4904-9a6d-9b6ae254a978 0555-0952 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate TABLET ORAL 20010212 ANDA ANDA040361 Barr Laboratories Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0953_c8ac3d3d-4961-4904-9a6d-9b6ae254a978 0555-0953 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate TABLET ORAL 20010212 ANDA ANDA040361 Barr Laboratories Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0954_d653c307-201c-4d22-ad60-c29fc6bee82a 0555-0954 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20020226 ANDA ANDA076137 Barr Laboratories Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0955_d653c307-201c-4d22-ad60-c29fc6bee82a 0555-0955 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20020226 ANDA ANDA076137 Barr Laboratories Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0956_d653c307-201c-4d22-ad60-c29fc6bee82a 0555-0956 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20020226 ANDA ANDA076137 Barr Laboratories Inc. DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0971_a7ba6926-fcb6-4406-919c-290f2357934f 0555-0971 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020211 ANDA ANDA040422 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0972_a7ba6926-fcb6-4406-919c-290f2357934f 0555-0972 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020211 ANDA ANDA040422 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0973_a7ba6926-fcb6-4406-919c-290f2357934f 0555-0973 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020211 ANDA ANDA040422 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0974_a7ba6926-fcb6-4406-919c-290f2357934f 0555-0974 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020211 ANDA ANDA040422 Barr Laboratories Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0555-0997_a5365fc8-44fd-4872-83bb-342a7c18e5c7 0555-0997 HUMAN PRESCRIPTION DRUG Fludrocortisone Acetate Fludrocortisone Acetate TABLET ORAL 20030214 ANDA ANDA040425 Barr Laboratories Inc. FLUDROCORTISONE ACETATE .1 mg/1 0555-1009_cfe78ca8-4b34-459c-9f44-26114a4649ac 0555-1009 HUMAN PRESCRIPTION DRUG Clonidine Clonidine PATCH, EXTENDED RELEASE TRANSDERMAL 20100825 ANDA ANDA079090 Barr Laboratories Inc. CLONIDINE .1 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0555-1010_cfe78ca8-4b34-459c-9f44-26114a4649ac 0555-1010 HUMAN PRESCRIPTION DRUG Clonidine Clonidine PATCH, EXTENDED RELEASE TRANSDERMAL 20100825 ANDA ANDA079090 Barr Laboratories Inc. CLONIDINE .2 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0555-1011_cfe78ca8-4b34-459c-9f44-26114a4649ac 0555-1011 HUMAN PRESCRIPTION DRUG Clonidine Clonidine PATCH, EXTENDED RELEASE TRANSDERMAL 20100825 ANDA ANDA079090 Barr Laboratories Inc. CLONIDINE .3 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0555-1020_5fd5061f-3f9b-4c74-b2f7-f9b4b92826c0 0555-1020 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide Galantamine Hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20081014 ANDA ANDA078189 Barr Laboratories Inc. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0555-1021_5fd5061f-3f9b-4c74-b2f7-f9b4b92826c0 0555-1021 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide Galantamine Hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20081015 ANDA ANDA078189 Barr Laboratories Inc. GALANTAMINE HYDROBROMIDE 16 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0555-1022_5fd5061f-3f9b-4c74-b2f7-f9b4b92826c0 0555-1022 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide Galantamine Hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20081015 ANDA ANDA078189 Barr Laboratories Inc. GALANTAMINE HYDROBROMIDE 24 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0555-1054_ebabd195-9d21-4f9a-906f-eddfcb290c55 0555-1054 HUMAN PRESCRIPTION DRUG Claravis isotretinoin CAPSULE ORAL 20030509 ANDA ANDA076356 Barr Laboratories, Inc. ISOTRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 0555-1055_ebabd195-9d21-4f9a-906f-eddfcb290c55 0555-1055 HUMAN PRESCRIPTION DRUG Claravis isotretinoin CAPSULE ORAL 20030509 ANDA ANDA076135 Barr Laboratories, Inc. ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 0555-1056_ebabd195-9d21-4f9a-906f-eddfcb290c55 0555-1056 HUMAN PRESCRIPTION DRUG Claravis isotretinoin CAPSULE ORAL 20060518 ANDA ANDA076135 Barr Laboratories, Inc. ISOTRETINOIN 30 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 0555-1057_ebabd195-9d21-4f9a-906f-eddfcb290c55 0555-1057 HUMAN PRESCRIPTION DRUG Claravis isotretinoin CAPSULE ORAL 20030509 ANDA ANDA076135 Barr Laboratories, Inc. ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 0555-1883_ded56918-ddc7-4d56-808d-4c16f5329abd 0555-1883 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20080125 20150331 ANDA ANDA081297 Barr Laboratories Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 0555-9008_aef7feb4-3736-4ac6-9083-3962bd4b4a19 0555-9008 HUMAN PRESCRIPTION DRUG Nortrel (28 Day Regimen) Norethindrone and Ethinyl Estradiol KIT 20010606 ANDA ANDA072695 Barr Laboratories Inc. 0555-9009_aef7feb4-3736-4ac6-9083-3962bd4b4a19 0555-9009 HUMAN PRESCRIPTION DRUG Nortrel (21 Day Regimen) Norethindrone and Ethinyl Estradiol TABLET ORAL 20010613 ANDA ANDA072693 Barr Laboratories Inc. ETHINYL ESTRADIOL; NORETHINDRONE .035; 1 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0555-9010_aef7feb4-3736-4ac6-9083-3962bd4b4a19 0555-9010 HUMAN PRESCRIPTION DRUG Nortrel (28 Day Regimen) Norethindrone and Ethinyl Estradiol KIT 20010606 ANDA ANDA072696 Barr Laboratories Inc. 0555-9012_800b819a-8592-4d99-bb2c-8b476026d058 0555-9012 HUMAN PRESCRIPTION DRUG Nortrel 7/7/7 (28 Day Regimen) Norethindrone and Ethinyl Estradiol KIT 20030102 ANDA ANDA075478 Barr Laboratories Inc. 0555-9014_b83c9300-f9c6-47fa-a0f7-385b72d4c2d5 0555-9014 HUMAN PRESCRIPTION DRUG Lessina levonorgestrel and ethinyl estradiol KIT 20020422 ANDA ANDA075803 Barr Laboratories Inc. 0555-9016_7b6681a8-8cef-4727-a6c7-33929829ac40 0555-9016 HUMAN PRESCRIPTION DRUG Sprintec Norgestimate and Ethinyl Estradiol KIT 20020926 ANDA ANDA075804 Barr Laboratories Inc. 0555-9018_49794bb6-9894-411a-a448-339e292320fb 0555-9018 HUMAN PRESCRIPTION DRUG Tri-Sprintec norgestimate and ethinyl estradiol KIT 20031229 ANDA ANDA075808 Barr Laboratories Inc. 0555-9020_2cec504a-7161-463d-b5c4-9e3cb9380eda 0555-9020 HUMAN PRESCRIPTION DRUG Portia levonorgestrel and ethinyl estradiol KIT 20020627 ANDA ANDA075866 Barr Laboratories Inc. 0555-9025_ceddd4c3-4827-4294-8767-d1e781a1d611 0555-9025 HUMAN PRESCRIPTION DRUG Junel 1/20 norethindrone acetate and ethinyl estradiol TABLET ORAL 20030918 ANDA ANDA076380 Barr Laboratories Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 20; 1 ug/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0555-9026_ceddd4c3-4827-4294-8767-d1e781a1d611 0555-9026 HUMAN PRESCRIPTION DRUG Junel Fe 1/20 norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20030918 ANDA ANDA076081 Barr Laboratories Inc. 0555-9027_ceddd4c3-4827-4294-8767-d1e781a1d611 0555-9027 HUMAN PRESCRIPTION DRUG Junel 1.5/30 norethindrone acetate and ethinyl estradiol TABLET ORAL 20030918 ANDA ANDA076381 Barr Laboratories Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 30; 1.5 ug/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0555-9028_ceddd4c3-4827-4294-8767-d1e781a1d611 0555-9028 HUMAN PRESCRIPTION DRUG Junel Fe 1.5/30 norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20030918 ANDA ANDA076064 Barr Laboratories Inc. 0555-9032_9d3f139b-7f5a-46ae-989d-adc73d5cf1c5 0555-9032 HUMAN PRESCRIPTION DRUG Tri-Legest Fe 28 Day Norethindrone Acetate and Ethinyl Estradiol KIT 20071026 ANDA ANDA076105 Barr Laboratories Inc. 0555-9034_c921e889-d7e1-412f-9e37-13bd31261095 0555-9034 HUMAN PRESCRIPTION DRUG Balziva Norethindrone and Ethinyl Estradiol KIT 20061016 ANDA ANDA076238 Barr Laboratories Inc. 0555-9043_cce61fa1-95eb-467f-8641-bdc822d00d5d 0555-9043 HUMAN PRESCRIPTION DRUG Apri Desogestrel and Ethinyl Estradiol KIT 19991022 ANDA ANDA075256 Barr Laboratories Inc. 0555-9045_dbe6ddbd-c46a-4162-9d96-4b516c1b44d7 0555-9045 HUMAN PRESCRIPTION DRUG Aviane levonorgestrel and ethinyl estradiol KIT 20010430 ANDA ANDA075796 Barr Laboratories Inc. 0555-9047_e0f13e22-41c1-45aa-875c-6ece49990a26 0555-9047 HUMAN PRESCRIPTION DRUG Enpresse levonorgestrel and ethinyl estradiol KIT 20020627 ANDA ANDA075809 Barr Laboratories Inc. 0555-9049_143d035e-f885-4ca9-a37c-b43e26c65aeb 0555-9049 HUMAN PRESCRIPTION DRUG Cryselle norgestrel and ethinyl estradiol KIT 20020724 ANDA ANDA075840 Barr Laboratories Inc. 0555-9050_68fbdcd4-f8e0-4a7f-8a49-c5e9dd7d3d14 0555-9050 HUMAN PRESCRIPTION DRUG Kariva Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol KIT 20020408 ANDA ANDA075863 Barr Laboratories Inc. 0555-9051_450e3af9-143e-46ce-83fc-2e169cb49f72 0555-9051 HUMAN PRESCRIPTION DRUG Velivet Triphasic Regimen Desogestrel and Ethinyl Estradiol KIT 20040301 ANDA ANDA076455 Barr Laboratories Inc. 0555-9064_1f1de674-d5a8-49a2-bc68-d17adfb9db96 0555-9064 HUMAN PRESCRIPTION DRUG Kelnor 1/35 ethynodiol diacetate and ethinyl estradiol KIT 20050620 ANDA ANDA076785 Barr Laboratories Inc. 0555-9066_6363caa8-27b4-4b43-9e7d-7f8fbc3dd36d 0555-9066 HUMAN PRESCRIPTION DRUG Aranelle norethindrone and ethinyl estradiol KIT 20041004 ANDA ANDA076783 Barr Laboratories Inc. 0555-9123_106a1084-010c-4f7d-ae63-5c6623e10a78 0555-9123 HUMAN PRESCRIPTION DRUG Jolessa levonorgestrel / ethinyl estradiol KIT 20031013 NDA AUTHORIZED GENERIC NDA021544 Barr Laboratories Inc. 0555-9131_7ae51f8c-8ea0-4502-8d7b-d0c0b1a295ba 0555-9131 HUMAN PRESCRIPTION DRUG OCELLA drospirenone and ethinyl estradiol KIT 20010611 NDA AUTHORIZED GENERIC NDA021098 BARR LABORATORIES, INC. 0562-7805_787b556c-4c29-f03d-5b8c-54190490d130 0562-7805 PLASMA DERIVATIVE RhoGAM Ultra-Filtered PLUS HUMAN RHO(D) IMMUNE GLOBULIN INJECTION, SOLUTION INTRAMUSCULAR 20070309 BLA BLA103777 Kedrion Melville, Inc. HUMAN RHO(D) IMMUNE GLOBULIN 300 ug/1 Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 0562-7806_787b556c-4c29-f03d-5b8c-54190490d130 0562-7806 PLASMA DERIVATIVE MICRhoGAM Ultra-Filtered PLUS HUMAN RHO(D) IMMUNE GLOBULIN INJECTION, SOLUTION INTRAMUSCULAR 20070309 BLA BLA103777 Kedrion Melville, Inc. HUMAN RHO(D) IMMUNE GLOBULIN 50 ug/1 Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 0573-0133_928507c7-4dbc-4848-b450-6dfaabc06575 0573-0133 HUMAN OTC DRUG Advil ibuprofen sodium TABLET, COATED ORAL 20130708 NDA NDA201803 Pfizer Consumer Healthcare IBUPROFEN SODIUM 256 mg/1 0573-0134_928507c7-4dbc-4848-b450-6dfaabc06575 0573-0134 HUMAN OTC DRUG Advil ibuprofen sodium TABLET, COATED ORAL 20130708 NDA NDA201803 Pfizer Consumer Healthcare IBUPROFEN SODIUM 256 mg/1 0573-0150_d4bb8e69-0fd4-4f64-8bbd-4d746161fe29 0573-0150 HUMAN OTC DRUG ADVIL ibuprofen TABLET, COATED ORAL 19840518 NDA NDA018989 Pfizer Consumer Healthcare IBUPROFEN 200 mg/1 0573-0151_d4bb8e69-0fd4-4f64-8bbd-4d746161fe29 0573-0151 HUMAN OTC DRUG ADVIL ibuprofen TABLET, COATED ORAL 19840518 NDA NDA018989 Pfizer Consumer Healthcare IBUPROFEN 200 mg/1 0573-0154_d4bb8e69-0fd4-4f64-8bbd-4d746161fe29 0573-0154 HUMAN OTC DRUG ADVIL ibuprofen TABLET, COATED ORAL 19840518 NDA NDA018989 Pfizer Consumer Healthcare IBUPROFEN 200 mg/1 0573-0160_d4bb8e69-0fd4-4f64-8bbd-4d746161fe29 0573-0160 HUMAN OTC DRUG ADVIL ibuprofen TABLET, COATED ORAL 19840518 NDA NDA018989 Pfizer Consumer Healthcare IBUPROFEN 200 mg/1 0573-0161_d4bb8e69-0fd4-4f64-8bbd-4d746161fe29 0573-0161 HUMAN OTC DRUG ADVIL ibuprofen TABLET, COATED ORAL 19840518 NDA NDA018989 Pfizer Consumer Healthcare IBUPROFEN 200 mg/1 0573-0164_d003a5c2-fdd8-4514-a1f1-88bf689c38ce 0573-0164 HUMAN OTC DRUG ADVIL PM diphenhydramine citrate and ibuprofen TABLET, COATED ORAL 20051221 NDA NDA021394 Pfizer Consumer Healthcare DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 0573-0165_d4bb8e69-0fd4-4f64-8bbd-4d746161fe29 0573-0165 HUMAN OTC DRUG ADVIL ibuprofen TABLET, COATED ORAL 19840518 NDA NDA018989 Pfizer Consumer Healthcare IBUPROFEN 200 mg/1 0573-0166_d4bb8e69-0fd4-4f64-8bbd-4d746161fe29 0573-0166 HUMAN OTC DRUG ADVIL ibuprofen TABLET, COATED ORAL 19840518 NDA NDA018989 Pfizer Consumer Healthcare IBUPROFEN 200 mg/1 0573-0167_8cd6e109-8b53-44ff-aadd-744bc1a132f6 0573-0167 HUMAN OTC DRUG ADVIL PM diphenhydramine HCl, ibuprofen CAPSULE, LIQUID FILLED ORAL 20051220 NDA NDA021393 Pfizer Consumer Healthcare DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25; 200 mg/1; mg/1 0573-0168_cdf8ecf6-60c5-4a0a-b193-de83db980b9a 0573-0168 HUMAN OTC DRUG ADVIL MIGRAINE ibuprofen CAPSULE, LIQUID FILLED ORAL 20000316 NDA NDA020402 Pfizer Consumer Healthcare IBUPROFEN 200 mg/1 0573-0169_fa7252d0-96a9-46ce-9912-1d6782aab8f0 0573-0169 HUMAN OTC DRUG Advil ibuprofen CAPSULE, LIQUID FILLED ORAL 19950410 NDA NDA020402 Pfizer Consumer Healthcare IBUPROFEN 200 mg/1 0573-0170_2aa0f9cf-f058-4994-8ace-11f80aa783c7 0573-0170 HUMAN OTC DRUG CHILDRENS ADVIL ibuprofen SUSPENSION ORAL 19960627 NDA NDA020589 Pfizer Consumer Healthcare IBUPROFEN 100 mg/5mL 0573-0171_2aa0f9cf-f058-4994-8ace-11f80aa783c7 0573-0171 HUMAN OTC DRUG CHILDRENS ADVIL ibuprofen SUSPENSION ORAL 19960627 NDA NDA020589 Pfizer Consumer Healthcare IBUPROFEN 100 mg/5mL 0573-0174_2aa0f9cf-f058-4994-8ace-11f80aa783c7 0573-0174 HUMAN OTC DRUG CHILDRENS ADVIL ibuprofen SUSPENSION ORAL 19960627 NDA NDA020589 Pfizer Consumer Healthcare IBUPROFEN 100 mg/5mL 0573-0175_2e13c128-96aa-41dc-82cc-1d22eb210b05 0573-0175 HUMAN OTC DRUG JUNIOR STRENGTH ADVIL ibuprofen TABLET, COATED ORAL 20110621 NDA NDA020267 Pfizer Consumer Healthcare IBUPROFEN 100 mg/1 0573-0179_684651b4-e120-49cf-86c5-12d08a36ac85 0573-0179 HUMAN OTC DRUG JUNIOR STRENGTH ADVIL ibuprofen TABLET, CHEWABLE ORAL 20110601 NDA NDA020944 Pfizer Consumer Healthcare IBUPROFEN 100 mg/1 0573-0180_1f9193fe-2b81-495f-b661-1badef7c9f11 0573-0180 HUMAN OTC DRUG ADVIL COLD AND SINUS ibuprofen, pseudoephedrine HCl TABLET, COATED ORAL 19890919 NDA NDA019771 Pfizer Consumer Healthcare IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 0573-0184_8cadba93-d69b-9f9e-050d-be5dd898ab5d 0573-0184 HUMAN OTC DRUG ADVIL COLD AND SINUS ibuprofen, pseudoephedrine HCl CAPSULE, LIQUID FILLED ORAL 20020530 NDA NDA021374 Pfizer Consumer Healthcare IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 0573-0187_502b0fb0-7f13-ccfe-69e3-70e458042224 0573-0187 HUMAN OTC DRUG CHILDRENS ADVIL COLD ibuprofen, pseudoephedrine HCl SUSPENSION ORAL 20020418 NDA NDA021373 Pfizer Consumer Healthcare IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100; 15 mg/5mL; mg/5mL 0573-0188_f5d1d83b-d7c0-42c2-8baa-af0ae32c27c5 0573-0188 HUMAN OTC DRUG ADVIL ALLERGY SINUS chlorpheniramine maleate, ibuprofen, pseudoephedrine HCl TABLET, COATED ORAL 20021220 NDA NDA021441 Pfizer Consumer Healthcare CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 200; 30 mg/1; mg/1; mg/1 0573-0191_dcd11696-ff2b-405b-8ce0-c902a4cdb096 0573-0191 HUMAN OTC DRUG INFANTS ADVIL ibuprofen SUSPENSION/ DROPS ORAL 19980130 NDA NDA020812 Pfizer Consumer Healthcare IBUPROFEN 50 mg/1.25mL 0573-0195_37fc5c7c-b5d1-4998-b63b-bf50aa6c83db 0573-0195 HUMAN OTC DRUG ADVIL CONGESTION RELIEF ibuprofen and phenylephrine hydrochloride TABLET, FILM COATED ORAL 20101004 NDA NDA022565 Pfizer Consumer Healthcare IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 0573-0196_a6f8f93b-3ad5-4c0c-9919-d8d94a92af3b 0573-0196 HUMAN OTC DRUG Advil Allergy and Congestion Relief chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride TABLET, COATED ORAL 20120723 NDA NDA022113 Pfizer Consumer Healthcare CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 4; 200; 10 mg/1; mg/1; mg/1 0573-0207_2aa0f9cf-f058-4994-8ace-11f80aa783c7 0573-0207 HUMAN OTC DRUG CHILDRENS ADVIL ibuprofen SUSPENSION ORAL 20121101 NDA NDA020589 Pfizer Consumer Healthcare IBUPROFEN 100 mg/5mL 0573-0213_4d9b4569-8d6f-4772-93d4-036e4ae90e6b 0573-0213 HUMAN OTC DRUG ANBESOL REGULAR STRENGTH benzocaine SOLUTION TOPICAL 20040511 OTC MONOGRAPH NOT FINAL part356 Pfizer Consumer Healthcare BENZOCAINE 100 mg/mL 0573-0215_4d9b4569-8d6f-4772-93d4-036e4ae90e6b 0573-0215 HUMAN OTC DRUG ANBESOL MAXIMUM STRENGTH benzocaine SOLUTION TOPICAL 20050511 OTC MONOGRAPH NOT FINAL part356 Pfizer Consumer Healthcare BENZOCAINE 200 mg/mL 0573-0216_4b7879db-127b-7945-9033-c5ce99a2ffc4 0573-0216 HUMAN OTC DRUG BABY ANBESOL benzocaine GEL TOPICAL 20040401 OTC MONOGRAPH FINAL part356 Wyeth Consumer Healthcare BENZOCAINE 75 mg/g 0573-0218_4d9b4569-8d6f-4772-93d4-036e4ae90e6b 0573-0218 HUMAN OTC DRUG ANBESOL REGULAR STRENGTH benzocaine GEL TOPICAL 20050511 OTC MONOGRAPH NOT FINAL part356 Pfizer Consumer Healthcare BENZOCAINE 100 mg/g 0573-0223_4d9b4569-8d6f-4772-93d4-036e4ae90e6b 0573-0223 HUMAN OTC DRUG ANBESOL JR benzocaine GEL TOPICAL 20050511 OTC MONOGRAPH NOT FINAL part356 Pfizer Consumer Healthcare BENZOCAINE 100 mg/g 0573-0225_4d9b4569-8d6f-4772-93d4-036e4ae90e6b 0573-0225 HUMAN OTC DRUG ANBESOL MAXIMUM STRENGTH benzocaine GEL TOPICAL 20050511 OTC MONOGRAPH NOT FINAL part356 Pfizer Consumer Healthcare BENZOCAINE 200 mg/g 0573-0232_2aa0f9cf-f058-4994-8ace-11f80aa783c7 0573-0232 HUMAN OTC DRUG CHILDRENS ADVIL ibuprofen SUSPENSION ORAL 20140601 NDA NDA020589 Pfizer Consumer Healthcare IBUPROFEN 100 mg/5mL 0573-0246_a76d60e7-6033-c134-7cef-7e4d297eb90e 0573-0246 HUMAN OTC DRUG ANBESOL COLD SORE THERAPY allantion, benzocaine, camphor, petrolatum OINTMENT TOPICAL 20060509 OTC MONOGRAPH FINAL part348 Pfizer Consumer Healthcare ALLANTOIN; BENZOCAINE; CAMPHOR (SYNTHETIC); PETROLATUM 10; 200; 30; 649 mg/g; mg/g; mg/g; mg/g 0573-0290_2aa0f9cf-f058-4994-8ace-11f80aa783c7 0573-0290 HUMAN OTC DRUG CHILDRENS ADVIL ibuprofen SUSPENSION ORAL 20100628 NDA NDA020589 Pfizer Consumer Healthcare IBUPROFEN 100 mg/5mL 0573-0556_7113425f-f3a7-081c-378a-d45a89b78ee8 0573-0556 HUMAN OTC DRUG PREPARATION H MEDICATED WIPES witch hazel CLOTH TOPICAL 20040202 OTC MONOGRAPH FINAL part346 Wyeth Consumer Healthcare WITCH HAZEL 5 g/1 0573-0558_a65d471b-ba8d-4fa9-8cf8-08c1066ded58 0573-0558 HUMAN OTC DRUG PREPARATION H TOTABLES IRRITATION RELIEF WIPES witch hazel CLOTH TOPICAL 20101121 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare WITCH HAZEL 5 g/1 0573-0559_348beba4-c1fb-4ac2-ab93-51688ce7c6e7 0573-0559 HUMAN OTC DRUG PREPARATION H MEDICATED WIPES FOR WOMEN witch hazel CLOTH TOPICAL 20140401 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare WITCH HAZEL 2 g/1 0573-1191_a610b9a8-110e-46aa-b8ed-58d7bb16db7f 0573-1191 HUMAN OTC DRUG DRISTAN 12 HR OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20040101 OTC MONOGRAPH FINAL part341 Pfizer Consumer Healthcare OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL 0573-1238_0ac416e9-d1c2-44e4-cb36-eafd2ea09a7b 0573-1238 HUMAN OTC DRUG DRISTAN COLD MULTISYMPTOM acetaminophen, chlorpheniramine maleate, phenylephrine HCl TABLET ORAL 20050505 OTC MONOGRAPH FINAL part341 Pfizer Consumer Healthcare ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 0573-1900_e105cd3c-5b48-6959-16be-4e2c44008c68 0573-1900 HUMAN OTC DRUG CHAPSTICK CLASSICS ORIGINAL padimate O, petrolatum STICK TOPICAL 20040101 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare PADIMATE O; PETROLATUM 15; 440 mg/g; mg/g 0573-1901_4cf3a99e-92cc-444c-91f2-08d3cb2d8e3e 0573-1901 HUMAN OTC DRUG ChapStick Classic Original PETROLATUM STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare PETROLATUM 450 mg/g 0573-1905_e105cd3c-5b48-6959-16be-4e2c44008c68 0573-1905 HUMAN OTC DRUG CHAPSTICK CLASSICS CHERRY padimate O, petrolatum STICK TOPICAL 20040128 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare PADIMATE O; PETROLATUM 15; 440 mg/g; mg/g 0573-1906_cf44f7c7-4cfa-4c63-9140-0bc8c890cc4d 0573-1906 HUMAN OTC DRUG ChapStick Classic Cherry PETROLATUM STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare PETROLATUM 450 mg/g 0573-1911_e105cd3c-5b48-6959-16be-4e2c44008c68 0573-1911 HUMAN OTC DRUG CHAPSTICK CLASSICS SPEARMINT padimate O, petrolatum STICK TOPICAL 20040101 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare PADIMATE O; PETROLATUM 15; 440 mg/g; mg/g 0573-1912_82ea8570-03fb-4418-bcba-aeeab3c47ec9 0573-1912 HUMAN OTC DRUG ChapStick Classic Spearmint PETROLATUM STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare PETROLATUM 450 mg/g 0573-1915_e105cd3c-5b48-6959-16be-4e2c44008c68 0573-1915 HUMAN OTC DRUG CHAPSTICK CLASSICS STRAWBERRY padimate O, petrolatum STICK TOPICAL 20040101 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare PADIMATE O; PETROLATUM 15; 440 mg/g; mg/g 0573-1916_854fbc99-caed-4f95-b0ff-643a21a2249c 0573-1916 HUMAN OTC DRUG ChapStick Classic Strawberry PETROLATUM STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare PETROLATUM 450 mg/g 0573-1920_d8f09f7f-08a6-4989-8c44-18f3ef89917a 0573-1920 HUMAN OTC DRUG CHAPSTICK MEDICATED camphor, menthol, petrolatum, phenol STICK TOPICAL 20040501 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare CAMPHOR (SYNTHETIC); MENTHOL; PETROLATUM; PHENOL 10; 6; 410; 5 mg/g; mg/g; mg/g; mg/g 0573-1925_ad5635f7-d78e-4b04-8b77-080f042c2346 0573-1925 HUMAN OTC DRUG CHAPSTICK MOISTURIZER octinoxate, oxybenzone, petrolatum STICK TOPICAL 20041101 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 407 mg/g; mg/g; mg/g 0573-1926_109022e9-7bd1-e5c2-1fc7-d9c978a6c603 0573-1926 HUMAN OTC DRUG CHAPSTICK MOISTURIZER octinoxate, oxybenzone, petrolatum GEL TOPICAL 20040101 OTC MONOGRAPH FINAL part347 Wyeth Consumer Healthcare OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 330 mg/g; mg/g; mg/g 0573-1927_51c60a46-fcde-4b17-97da-804b05cc994a 0573-1927 HUMAN OTC DRUG Chapstick Moisturizer OCTINOXATE, OXYBENZONE, and PETROLATUM STICK ORAL 20120803 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 387 mg/g; mg/g; mg/g 0573-1928_ad5635f7-d78e-4b04-8b77-080f042c2346 0573-1928 HUMAN OTC DRUG CHAPSTICK MOISTURIZER GREEN APPLE octinoxate, oxybenzone, petrolatum STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 334 mg/g; mg/g; mg/g 0573-1929_d7c411cd-a901-027f-124b-87c44860e9cc 0573-1929 HUMAN OTC DRUG CHAPSTICK LIPSHIELD 365 avobenzone, dimethicone, homosalate, octinoxate, octisalate, oxybenzone STICK TOPICAL 20110701 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare AVOBENZONE; DIMETHICONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 15; 60; 65; 45; 50 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g 0573-1930_ad5635f7-d78e-4b04-8b77-080f042c2346 0573-1930 HUMAN OTC DRUG CHAPSTICK MOISTURIZER VANILLA MINT octinoxate, oxybenzone, petrolatum STICK TOPICAL 20040723 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 387 mg/g; mg/g; mg/g 0573-1934_ab6d1370-c05d-4f6c-91af-8a525b8a6bd3 0573-1934 HUMAN OTC DRUG Chapstick Moisturizer Raspberry Creme octinoxate, oxybenzone and petrolatum STICK TOPICAL 20120803 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 387 mg/4g; mg/4g; mg/4g 0573-1935_bb9f917d-0fb9-755b-4a99-e4892dbfc2f3 0573-1935 HUMAN OTC DRUG CHAPSTICK OVERNIGHT dimethicone GEL TOPICAL 20040101 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare DIMETHICONE 20 mg/g 0573-1940_507b4f1b-dac0-4949-bb29-6e49438a2b83 0573-1940 HUMAN OTC DRUG CHAPSTICK ULTRA SPF 30 OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, PETROLATUM STICK TOPICAL 20040130 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; PETROLATUM 75; 50; 70; 50; 300 mg/g; mg/g; mg/g; mg/g; mg/g 0573-1945_5780e0a2-e9af-4f9b-af6c-dea115bdb5a8 0573-1945 HUMAN OTC DRUG CHAPSTICK FLAVA CRAZE petrolatum KIT 20060714 OTC MONOGRAPH FINAL part347 Pfizer Consumer HealthCare 0573-1961_601c5de8-0807-4463-9653-40879c8501a8 0573-1961 HUMAN OTC DRUG ChapStick Hydration Lock Day and Night white petrolatum, octinoxate, oxybenzone KIT 20140801 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare 0573-1993_99c72544-0aa3-179b-4b74-3d74b7ed539d 0573-1993 HUMAN OTC DRUG CHAPSTICK ULTRA MOISTURE octinoxate, oxybenzone, petrolatum GEL TOPICAL 20101209 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 330 mg/g; mg/g; mg/g 0573-1999_ff6541c7-e508-4672-8d11-11aa0594e285 0573-1999 HUMAN OTC DRUG ChapStick Active Sport Ready AVOBENZONE, DIMETHICONE 100, HOMOSALATE, OCTINOXATE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20120730 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare AVOBENZONE; DIMETHICONE 100; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 15; 60; 65; 45; 50 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g 0573-2400_5c371d53-b93d-565e-bae6-1354c99d9035 0573-2400 HUMAN OTC DRUG AXID AR nizatidine TABLET, FILM COATED ORAL 19960509 NDA NDA020555 Wyeth Consumer Healthcare NIZATIDINE 75 mg/1 0573-2450_bbce0417-4a19-4e40-98b8-75575350342a 0573-2450 HUMAN OTC DRUG Nexium 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20140527 NDA NDA204655 Pfizer Consumer Healthcare ESOMEPRAZOLE MAGNESIUM 20 mg/1 0573-2620_e55877e9-56ac-4374-a377-866d3ad6ebb6 0573-2620 HUMAN OTC DRUG ALAVERT ALLERGY loratadine TABLET, ORALLY DISINTEGRATING ORAL 20021219 NDA NDA021375 Pfizer Consumer Healthcare LORATADINE 10 mg/1 0573-2621_e55877e9-56ac-4374-a377-866d3ad6ebb6 0573-2621 HUMAN OTC DRUG ALAVERT ALLERGY loratadine TABLET, ORALLY DISINTEGRATING ORAL 20021219 NDA NDA021375 Pfizer Consumer Healthcare LORATADINE 10 mg/1 0573-2660_91ed3e9a-e637-bfd9-e403-eef89c2c6816 0573-2660 HUMAN OTC DRUG ALAVERT ALLERGY SINUS D-12 loratadine, pseudoephedrine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20040130 ANDA ANDA076050 Wyeth Consumer Healthcare LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 0573-2830_b1db6c15-2f10-abed-12ef-0f0318ea8047 0573-2830 HUMAN OTC DRUG PREPARATION H HYDROCORTISONE hydrocortisone CREAM TOPICAL 20040101 OTC MONOGRAPH FINAL part348 Pfizer Consumer Healthcare HYDROCORTISONE 10 mg/g 0573-2840_e14f1f6b-339f-6928-f126-f4bc95000499 0573-2840 HUMAN OTC DRUG PREPARATION H COOLING GEL phenylephrine HCl, witch hazel GEL TOPICAL 20040101 OTC MONOGRAPH FINAL part346 Wyeth Consumer Healthcare PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL 2.5; 500 mg/g; mg/g 0573-2841_a887d291-38d1-4115-8e20-1b51aa97af9c 0573-2841 HUMAN OTC DRUG Preparation H Totables Burning Relief phenylephrine hydrochloride and witch hazel GEL TOPICAL 20101010 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL 2.5; 500 mg/g; mg/g 0573-2868_dc760639-af70-2eb1-149f-7bc73d854021 0573-2868 HUMAN OTC DRUG PREPARATION H CREAM MAX STRENGTH glycerin, petrolatum, phenylephrine HCl, pramoxine HCl CREAM TOPICAL 20040701 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 144; 150; 2.5; 10 mg/g; mg/g; mg/g; mg/g 0573-2869_201803ec-aa3d-4627-914c-44a8f2463c88 0573-2869 HUMAN OTC DRUG Preparation H Totables Pain Relief GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, and PETROLATUM CREAM TOPICAL 20101010 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 144; 150; 2.5; 10 mg/g; mg/g; mg/g; mg/g 0573-2871_dc345e8c-e8a8-42e6-880b-98762349ee65 0573-2871 HUMAN OTC DRUG PREPARATION H mineral oil, petrolatum, phenylephrine HCl OINTMENT TOPICAL 20040301 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 749; 2.5 mg/g; mg/g; mg/g 0573-2880_65655b15-a3aa-4e0f-910f-641b9813086d 0573-2880 HUMAN OTC DRUG PREPARATION H cocoa butter, phenylephrine hydrochloride SUPPOSITORY RECTAL 20040105 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.25 mg/1; mg/1 0573-2883_65655b15-a3aa-4e0f-910f-641b9813086d 0573-2883 HUMAN OTC DRUG PREPARATION H cocoa butter, phenylephrine hydrochloride SUPPOSITORY RECTAL 20040105 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.25 mg/1; mg/1 0573-2952_983b7623-b288-48db-961c-64dcc6a758c1 0573-2952 HUMAN OTC DRUG PRIMATENE ephedrine hcl, guaifenesin TABLET ORAL 20040106 OTC MONOGRAPH FINAL part341 Pfizer Consumer Healthcare EPHEDRINE HYDROCHLORIDE; GUAIFENESIN 12.5; 200 mg/1; mg/1 0574-0014_8df4e43f-1c55-4eb8-8c88-5bba33dd65c5 0574-0014 HUMAN PRESCRIPTION DRUG Erythra-Derm Erythromycin SOLUTION TOPICAL 19880228 ANDA ANDA062687 Paddock Laboratories, Inc. ERYTHROMYCIN 20 mg/mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0574-0016_df3fdd8e-0c49-47f6-a86b-c0cfbad31f00 0574-0016 HUMAN PRESCRIPTION DRUG Clinda-Derm Clindamycin Phosphate SOLUTION TOPICAL 19921001 ANDA ANDA063329 Paddock Laboratoratories, LLC CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0574-0018_63470d81-e723-4911-be63-aadc18a736c9 0574-0018 HUMAN OTC DRUG Milk of Magnesia Magnesium Hydroxide SUSPENSION ORAL 19771001 OTC MONOGRAPH FINAL part331 Paddock Laboratories, LLC MAGNESIUM HYDROXIDE 80 mg/mL 0574-0067_cba29e3c-d446-4a70-928a-c98ed8eedcc6 0574-0067 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part333A Paddock Laboratories, LLC ISOPROPYL ALCOHOL 500 mg/mL 0574-0069_95ff8652-64fe-44c7-9ca2-567267db8582 0574-0069 HUMAN OTC DRUG Glutose 15 dextrose GEL ORAL 19960201 UNAPPROVED OTHER Paddock Laboratories, Inc. DEXTROSE 15 g/37.5g 0574-0106_ec3e7aac-bf4b-41c7-9f51-c46c54081851 0574-0106 HUMAN PRESCRIPTION DRUG Bromocriptine mesylate Bromocriptine mesylate TABLET ORAL 20081001 ANDA ANDA077646 Paddock Laboratories, LLC BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 0574-0107_75b943d4-1bd4-49f5-bc42-f435d6d02a38 0574-0107 HUMAN PRESCRIPTION DRUG Clotrimazole clotrimazole LOZENGE ORAL 20051201 ANDA ANDA076763 Paddock Laboratories, LLC CLOTRIMAZOLE 10 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0574-0110_c740b7fc-677b-48bf-ab2a-a51a6eb37bf3 0574-0110 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride MOEXIPRIL HYDROCHLORIDE TABLET, COATED ORAL 20061130 ANDA ANDA077536 Paddock Laboratories, Inc. MOEXIPRIL HYDROCHLORIDE 7.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0574-0112_c740b7fc-677b-48bf-ab2a-a51a6eb37bf3 0574-0112 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride MOEXIPRIL HYDROCHLORIDE TABLET, COATED ORAL 20061130 ANDA ANDA077536 Paddock Laboratories, Inc. MOEXIPRIL HYDROCHLORIDE 15 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0574-0113_755ff77f-297b-47f2-a5d9-13fe2668630c 0574-0113 HUMAN PRESCRIPTION DRUG Calcium Acetate CALCIUM ACETATE TABLET ORAL 20110913 ANDA ANDA091561 Paddock Laboratories, LLC CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0574-0115_f0cab6ed-5ce0-4216-8877-3b1fe082254e 0574-0115 HUMAN PRESCRIPTION DRUG FLAVOXATE HYDROCHLORIDE FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED ORAL 20041222 ANDA ANDA076831 Paddock Laboratories, LLC FLAVOXATE HYDROCHLORIDE 100 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0574-0116_d76c5a3b-8510-40a7-a337-4b08896fcc3a 0574-0116 HUMAN PRESCRIPTION DRUG Benzphetamine Hydrochloride BENZPHETAMINE HYDROCHLORIDE TABLET, COATED ORAL 20070501 ANDA ANDA040578 Paddock Laboratories, Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 0574-0118_2b3e4733-d8d7-48ba-9c9f-f0b827c5a52a 0574-0118 HUMAN PRESCRIPTION DRUG Trospium Chloride ER Trospium Chloride CAPSULE, EXTENDED RELEASE ORAL 20130607 ANDA ANDA201291 Paddock Laboratories, LLC TROSPIUM CHLORIDE 60 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0574-0120_a003785a-602c-4ac1-aa71-fa56b4329a6c 0574-0120 HUMAN PRESCRIPTION DRUG Actidose Activated Charcoal SUSPENSION ORAL 19831001 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC ACTIVATED CHARCOAL 208 mg/mL 0574-0121_a003785a-602c-4ac1-aa71-fa56b4329a6c 0574-0121 HUMAN PRESCRIPTION DRUG Actidose Aqua activated charcoal SUSPENSION ORAL 19840101 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC ACTIVATED CHARCOAL 208 mg/mL 0574-0122_ff6811b0-d845-4d77-8edd-aaaa3d62ce99 0574-0122 HUMAN OTC DRUG EZ Char Activated charcoal PELLET ORAL 20020114 OTC MONOGRAPH NOT FINAL part357A Paddock Laboratories, LLC ACTIVATED CHARCOAL 25 g/25g 0574-0129_1b2614a8-e016-467b-a25c-c9752e221098 0574-0129 HUMAN PRESCRIPTION DRUG Clindamycin Palmitate Hydrochloride Clindamycin Palmitate Hydrochloride GRANULE, FOR SOLUTION ORAL 20100121 ANDA ANDA090902 Paddock Laboratories, LLC CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0574-0133_ec5b10c0-18c0-4e76-af84-d908a723f1a0 0574-0133 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, COATED ORAL 20090701 ANDA ANDA090096 Paddock Laboratories, Inc. HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5; 7.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0574-0134_ec5b10c0-18c0-4e76-af84-d908a723f1a0 0574-0134 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, COATED ORAL 20090701 ANDA ANDA090096 Paddock Laboratories, Inc. HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5; 15 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0574-0135_ec5b10c0-18c0-4e76-af84-d908a723f1a0 0574-0135 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, COATED ORAL 20090701 ANDA ANDA090096 Paddock Laboratories, Inc. HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 25; 15 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0574-0145_9045d058-1427-4c21-a1cf-2a02d81c69f1 0574-0145 HUMAN PRESCRIPTION DRUG TROSPIUM CHLORIDE TROSPIUM CHLORIDE TABLET, FILM COATED ORAL 20101117 ANDA ANDA091573 Paddock LLC TROSPIUM CHLORIDE 20 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0574-0147_c737b7b2-4aba-490f-9c7f-4efe06cfbd95 0574-0147 HUMAN PRESCRIPTION DRUG famotidine famotidine POWDER, FOR SUSPENSION ORAL 20100528 NDA NDA019527 Paddock Laboratories, Inc. FAMOTIDINE 40 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0574-0148_83a5e667-3173-4d94-a9fe-a69376e118cf 0574-0148 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20040525 ANDA ANDA075988 Paddock Laboratories, Inc. PREDNISOLONE SODIUM PHOSPHATE 5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0574-0150_d6751105-8c4f-43fe-899e-56d9f493a606 0574-0150 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride SYRUP ORAL 20050502 ANDA ANDA076379 Paddock Laboratories, LLC MIDAZOLAM HYDROCHLORIDE 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0574-0152_149221bc-3dfc-46f9-bc27-dff8812d3a70 0574-0152 HUMAN PRESCRIPTION DRUG Caffeine Citrate CAFFEINE CITRATE SOLUTION ORAL 20060921 ANDA ANDA077304 Paddock Laboratories, LLC CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0574-0153_93cfdedb-ae3c-4b76-a5ee-4d5fa0df1276 0574-0153 HUMAN PRESCRIPTION DRUG morphine sulfate Morphine Sulfate SOLUTION ORAL 20120817 ANDA ANDA201574 Paddock Laboratories, LLC MORPHINE SULFATE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] 0574-0159_c72b47e8-3123-4a77-9678-5621dbadb1fa 0574-0159 HUMAN PRESCRIPTION DRUG OPIUM TINCTURE DEODORIZED Morphine TINCTURE ORAL 20110128 UNAPPROVED DRUG OTHER Paddock Laboratories, Inc. MORPHINE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0574-0162_c5855fad-0acb-4e4c-b186-bc759aa503f2 0574-0162 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION TOPICAL 20141124 ANDA ANDA202393 Paddock Laboratories, LLC DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0574-0163_9f038de9-af81-4871-b072-212b83f7ef0f 0574-0163 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam SOLUTION, CONCENTRATE ORAL 20090401 ANDA ANDA079244 Paddock Laboratories, LLC LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0574-0180_2c824a0e-afca-4959-b09b-279f518864ca 0574-0180 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200185 Paddock Laboratories, LLC POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0574-0181_2c824a0e-afca-4959-b09b-279f518864ca 0574-0181 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200185 Paddock Laboratories, LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0574-0193_f2ef2beb-7e59-4ca9-8d6e-656ae3814331 0574-0193 HUMAN PRESCRIPTION DRUG Indomethacin INDOMETHACIN CAPSULE, EXTENDED RELEASE ORAL 20101130 ANDA ANDA200529 Paddock Laboratories, LLC INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0574-0194_2b74a196-b7d8-40f7-9792-9f9182a903b2 0574-0194 HUMAN PRESCRIPTION DRUG Vitamin D ERGOCALCIFEROL CAPSULE, LIQUID FILLED ORAL 20091215 ANDA ANDA090455 Paddock Laboratories, LLC ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 0574-0195_d889cbdf-0480-44c8-9be7-27ca04a2178e 0574-0195 HUMAN PRESCRIPTION DRUG Mefenamic acid Mefenamic acid CAPSULE ORAL 20101119 ANDA ANDA090562 Paddock Laboratories, LLC. MEFENAMIC ACID 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0574-0214_e8caa421-49a6-41ef-aaea-3f8a88824edc 0574-0214 HUMAN PRESCRIPTION DRUG Naratriptan Hydrochloride Naratriptan Hydrochloride TABLET, FILM COATED ORAL 20100708 ANDA ANDA091326 Paddock Laboratories, LLC NARATRIPTAN HYDROCHLORIDE 1 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0574-0215_e8caa421-49a6-41ef-aaea-3f8a88824edc 0574-0215 HUMAN PRESCRIPTION DRUG Naratriptan Hydrochloride Naratriptan Hydrochloride TABLET, FILM COATED ORAL 20100708 ANDA ANDA091326 Paddock Laboratories, LLC NARATRIPTAN HYDROCHLORIDE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0574-0220_001aba90-99ed-41d6-8208-e7e66ee60331 0574-0220 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 Paddock Laboratories, Inc. LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 0574-0222_001aba90-99ed-41d6-8208-e7e66ee60331 0574-0222 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 Paddock Laboratories, Inc. LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 0574-0223_001aba90-99ed-41d6-8208-e7e66ee60331 0574-0223 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 Paddock Laboratories, Inc. LIOTHYRONINE SODIUM 50 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 0574-0240_9f471d1a-fc49-4f23-9a0a-a6c74129c4b8 0574-0240 HUMAN PRESCRIPTION DRUG Repaglinide REPAGLINIDE TABLET ORAL 20130809 ANDA ANDA201189 Paddock Laboratories, LLC REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0574-0241_9f471d1a-fc49-4f23-9a0a-a6c74129c4b8 0574-0241 HUMAN PRESCRIPTION DRUG Repaglinide REPAGLINIDE TABLET ORAL 20140122 ANDA ANDA201189 Paddock Laboratories, LLC REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0574-0242_9f471d1a-fc49-4f23-9a0a-a6c74129c4b8 0574-0242 HUMAN PRESCRIPTION DRUG Repaglinide REPAGLINIDE TABLET ORAL 20140122 ANDA ANDA201189 Paddock Laboratories, LLC REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0574-0250_5c6b4644-e793-4c13-a190-0ca543de7283 0574-0250 HUMAN PRESCRIPTION DRUG HYOSCYAMINE SULFATE HYOSCYAMINE SULFATE TABLET SUBLINGUAL 20120806 20150831 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC HYOSCYAMINE SULFATE .125 mg/1 0574-0292_8f143a75-f765-4eb8-9bc5-e93fb0d0d647 0574-0292 HUMAN PRESCRIPTION DRUG amiloride hydrocloride amiloride hydrocloride TABLET ORAL 20090406 NDA NDA018200 Paddock Laboratories, LLC AMILORIDE HYDROCHLORIDE 5 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 0574-0412_65451e5b-4df7-47fb-987d-d3d44b214027 0574-0412 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20060524 ANDA ANDA077893 Paddock Laboratories, Inc. POLYETHYLENE GLYCOL 3350 17 g/1 Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 0574-0420_4271e173-070a-4997-b3ce-db0ad878a14c 0574-0420 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone POWDER NOT APPLICABLE 19830408 UNAPPROVED OTHER Paddock Laboratories, Inc. HYDROCORTISONE 1 g/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0574-0425_039ebc5c-5b54-4805-9984-fe3b006b50bb 0574-0425 HUMAN PRESCRIPTION DRUG POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE and POTASSIUM CHLORIDE POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20100225 ANDA ANDA079232 Paddock Laboratories, Inc. POLYETHYLENE GLYCOL 3350 420 g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 0574-0426_d3000e00-72af-46c5-a97f-53ebd93fd50e 0574-0426 HUMAN PRESCRIPTION DRUG POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES With flavor packs POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20100225 ANDA ANDA090712 Paddock Laboratories, Inc. POLYETHYLENE GLYCOL 3350 60 g/L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 0574-0427_3d89fbc8-b445-4785-9f25-24acdf0fa52e 0574-0427 HUMAN PRESCRIPTION DRUG Clenz-Lyte Polyethylene Glycol 3350 POWDER, FOR SOLUTION NASOGASTRIC; ORAL 20100607 ANDA ANDA090769 Paddock Laboratories, Inc. POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 236; 2.97; 6.74; 5.86; 22.74 g/4L; g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0574-0428_933daf0e-36f2-487e-ad9b-91e37a99d271 0574-0428 HUMAN PRESCRIPTION DRUG POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20100225 ANDA ANDA090712 Paddock Laboratories, Inc. POLYETHYLENE GLYCOL 3350 60 g/L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 0574-0601_de96dc6e-e6d1-4383-9ce1-4d06bac08e00 0574-0601 HUMAN PRESCRIPTION DRUG Podocon 25 Podophyllum resin TINCTURE TOPICAL 19900901 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC PODOPHYLLUM RESIN 1 mg/4mL 0574-0611_0374a375-639c-439d-914c-538b1e790c07 0574-0611 HUMAN PRESCRIPTION DRUG PODOFILOX PODOFILOX SOLUTION TOPICAL 20020129 ANDA ANDA075600 Paddock Laboratories, LLC PODOFILOX 5 mg/mL Decreased Mitosis [PE] 0574-0618_b65fb583-333e-49d0-afa7-f5afc119fda2 0574-0618 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL 19971001 OTC MONOGRAPH NOT FINAL part334 Paddock Laboratories, LLC MINERAL OIL 99.9 mg/mL 0574-0790_a08256f9-af80-445e-9b01-23f99222324e 0574-0790 HUMAN PRESCRIPTION DRUG methazolamide methazolamide TABLET ORAL 20140930 ANDA ANDA040062 Paddock Laboratories, LLC METHAZOLAMIDE 25 mg/1 0574-0791_a08256f9-af80-445e-9b01-23f99222324e 0574-0791 HUMAN PRESCRIPTION DRUG methazolamide methazolamide TABLET ORAL 20140930 ANDA ANDA040062 Paddock Laboratories, LLC METHAZOLAMIDE 50 mg/1 0574-0805_9d305722-e74f-4f48-8d2c-0daa99144749 0574-0805 HUMAN PRESCRIPTION DRUG acetylcysteine Acetylcysteine INJECTION INTRAVENOUS 20121220 NDA NDA021539 Paddock Laboratories, LLC ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 0574-0815_84ef0ae0-1eca-44cc-9528-37c6a1521e55 0574-0815 HUMAN PRESCRIPTION DRUG Acetylcysteine acetylcysteine INJECTION INTRAVENOUS 20131015 NDA NDA021539 Paddock Laboratories, LLC ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 0574-0820_4b8d5294-f4bf-407d-ac90-457333c4bf2f 0574-0820 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20071221 ANDA ANDA040530 Paddock Laboratories, LLC TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0574-0821_ed284176-2ab1-4ee5-8eed-06af3df05785 0574-0821 HUMAN PRESCRIPTION DRUG Testosterone Enanthate Testosterone Enanthate INJECTION INTRAMUSCULAR 20070802 ANDA ANDA040575 Paddock Laboratories, Inc. TESTOSTERONE ENANTHATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0574-0823_149221bc-3dfc-46f9-bc27-dff8812d3a70 0574-0823 HUMAN PRESCRIPTION DRUG Caffeine Citrate CAFFEINE CITRATE INJECTION INTRAVENOUS 20060921 ANDA ANDA077233 Paddock Laboratories, LLC CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0574-0827_4b8d5294-f4bf-407d-ac90-457333c4bf2f 0574-0827 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20140501 ANDA ANDA091244 Paddock Laboratories, LLC TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0574-0840_ec23089a-0f82-40c5-a833-7ae6017d738e 0574-0840 HUMAN PRESCRIPTION DRUG Ibutilide Fumarate Ibutilide Fumarate INJECTION, SOLUTION INTRAVENOUS 20100113 ANDA ANDA090240 Paddock Laboratories, Inc. IBUTILIDE FUMARATE .1 mg/mL Antiarrhythmic [EPC] 0574-0850_50d789bd-18ce-420d-8410-960394341433 0574-0850 HUMAN PRESCRIPTION DRUG Dihydroergotamine Mesylate Dihydroergotamine Mesylate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20030429 ANDA ANDA040475 Paddock Laboratories, LLC DIHYDROERGOTAMINE MESYLATE 1 mg/mL Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient] 0574-0858_5ee0a217-5009-4f6a-ae18-72dc0857be34 0574-0858 HUMAN PRESCRIPTION DRUG Colistimethate COLISTIMETHATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20040320 ANDA ANDA065177 Paddock Laboratories, LLC COLISTIMETHATE SODIUM 150 mg/2mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 0574-0866_d93def6b-d783-4cc4-aa61-091ebc74ac65 0574-0866 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine INJECTION, SOLUTION INTRAVENOUS 20031007 ANDA ANDA065151 Perrigo Company CYCLOSPORINE 50 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0574-0870_c7c2c917-30fb-496d-b484-b7ac65b6c7d1 0574-0870 HUMAN PRESCRIPTION DRUG ESTRADIOL VALERATE ESTRADIOL VALERATE INJECTION, SOLUTION INTRAMUSCULAR 20100331 ANDA ANDA090920 Perrigo Company ESTRADIOL VALERATE 20 mg/mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0574-0872_c7c2c917-30fb-496d-b484-b7ac65b6c7d1 0574-0872 HUMAN PRESCRIPTION DRUG ESTRADIOL VALERATE ESTRADIOL VALERATE INJECTION, SOLUTION INTRAMUSCULAR 20100331 ANDA ANDA090920 Perrigo Company ESTRADIOL VALERATE 40 mg/mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0574-1103_455c437b-0224-415d-8b8e-8044ef8e231a 0574-1103 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride SOLUTION ORAL 20140826 ANDA ANDA204627 Paddock Laboratories, LLC CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 5; 60 mg/5mL; mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] CII 0574-2002_7aad2eb7-a89b-450f-8c55-c9da43e8cf16 0574-2002 HUMAN PRESCRIPTION DRUG Kionex Sodium Polystyrene Sulfonate SUSPENSION ORAL; RECTAL 20081230 ANDA ANDA040028 Paddock Laboratories, LLC SODIUM POLYSTYRENE SULFONATE 15 g/60mL 0574-2003_6a1ab414-4b9d-492f-8d8d-bc24be207ab7 0574-2003 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate Sodium Polystyrene Sulfonate SUSPENSION ORAL 20110921 ANDA ANDA090590 Paddock Laboratories, LLC SODIUM POLYSTYRENE SULFONATE 15 g/60mL 0574-2004_c4b11bf9-d030-4afb-b188-9a0066de5ce8 0574-2004 HUMAN PRESCRIPTION DRUG Kionex SODIUM POLYSTYRENE SULFONATE POWDER, FOR SUSPENSION ORAL; RECTAL 19980201 ANDA ANDA040029 Paddock Laboratories, LLC SODIUM POLYSTYRENE SULFONATE 4.1 meq/g 0574-2008_233f198b-cf3d-41ed-8094-60315dc46919 0574-2008 HUMAN PRESCRIPTION DRUG Nystop Nystatin POWDER TOPICAL 19960816 ANDA ANDA064118 Paddock Laboratories, LLC NYSTATIN 100000 [USP&apos'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 0574-2020_5032a76b-2dae-498b-83d5-2752a6920c61 0574-2020 HUMAN PRESCRIPTION DRUG Colocort Hydrocortisone SUSPENSION RECTAL 19991231 ANDA ANDA075172 Paddock Laboratories, LLC HYDROCORTISONE 100 mg/60mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0574-2021_fb4321bd-e02c-4977-9829-90e990c7b2c2 0574-2021 HUMAN PRESCRIPTION DRUG LAClotion Ammonium Lactate LOTION TOPICAL 20020611 ANDA ANDA075575 Paddock Laboratories, Inc. AMMONIUM LACTATE 120 mg/g 0574-2061_72733a8f-2995-4164-ae5d-438afba190fd 0574-2061 HUMAN PRESCRIPTION DRUG CICLOPIROX CICLOPIROX GEL TOPICAL 20090107 ANDA ANDA078266 Paddock Laboratories, Inc. CICLOPIROX 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 0574-2103_6cb5d2c9-29be-4ddd-ab67-e8e8a25a0a8d 0574-2103 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate LOTION TOPICAL 20120103 NDA AUTHORIZED GENERIC NDA021535 Paddock Laboratories, LLC CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0574-2121_2cfa5e09-fe8e-4797-a0bc-c1db72c3fddb 0574-2121 HUMAN PRESCRIPTION DRUG AMMONIUM LACTATE AMMONIUM LACTATE CREAM TOPICAL 20060207 ANDA ANDA076829 Paddock Laboratories, Inc. AMMONIUM LACTATE 120 mg/g 0574-3312_5fe0f114-67ae-44c5-906f-60e49a9a8475 0574-3312 HUMAN OTC DRUG castor oil castor oil LIQUID ORAL 19781001 OTC MONOGRAPH NOT FINAL part334 Paddock Laboratories, LLC CASTOR OIL 100 mg/100mL 0574-4005_e8f351d0-ba14-4610-aac6-416e04b818ec 0574-4005 HUMAN PRESCRIPTION DRUG epinastine hydrochloride epinastine hydrochloride SOLUTION/ DROPS OPHTHALMIC 20111101 ANDA ANDA090951 Perrigo Company EPINASTINE HYDROCHLORIDE .5 mg/mL Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 0574-4009_6dea775d-4188-4e23-8b41-6c850a803d3e 0574-4009 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Gramicidin Neomycin and Polymyxin B Sulfates and Gramicidin SOLUTION/ DROPS OPHTHALMIC 20080102 ANDA ANDA065187 Perrigo Company GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE .025; 1.75; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 0574-4021_3abbfb58-26d1-460d-a60f-db63c0193a0d 0574-4021 HUMAN PRESCRIPTION DRUG polycin bacitracin zinc and polymyxin b sulfates OINTMENT OPHTHALMIC 20141112 ANDA ANDA065022 Paddock Laboratories, LLC BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP&apos'U]/g; [USP&apos'U]/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 0574-4022_6ed2f2bd-9d2f-46af-a44c-95a02ca034de 0574-4022 HUMAN PRESCRIPTION DRUG Bacitracin Bacitracin OINTMENT OPHTHALMIC 20140310 ANDA ANDA061212 Paddock Laboratories, LLC BACITRACIN 500 [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE] 0574-4023_bd51c566-0d6e-4ff0-8593-8cf9f9d38c4e 0574-4023 HUMAN PRESCRIPTION DRUG Ilotycin Erythromycin OINTMENT OPHTHALMIC 20141008 ANDA ANDA062447 Paddock Laboratories, LLC ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0574-4024_87b45f99-a4d1-47e0-bbb6-50ca19c10010 0574-4024 HUMAN PRESCRIPTION DRUG erythromycin erythromycin OINTMENT OPHTHALMIC 20140508 ANDA ANDA062447 Paddock Laboratories, LLC ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0574-4025_4b8ca103-c863-492b-adc5-9691f01e795b 0574-4025 HUMAN OTC DRUG Puralube Light mineral oil, white petrolatum OINTMENT OPHTHALMIC 20140728 OTC MONOGRAPH FINAL part349 Paddock Laboratories, LLC LIGHT MINERAL OIL; PETROLATUM 150; 850 mg/g; mg/g 0574-4072_c4dafa35-2e51-4c24-9516-f5c8b716e091 0574-4072 HUMAN PRESCRIPTION DRUG garamycin gentamicin sulfate gentamicin sulfate SOLUTION OPHTHALMIC 20140605 ANDA ANDA065121 Paddock Laboratories, LLC GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0574-4100_2faffbf9-cb8e-48f3-b66a-9adf7c86127f 0574-4100 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin and Polymyxin B Sulfates and Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 20080102 ANDA ANDA065216 Perrigo Company HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0574-4102_b24f76fa-8bac-460b-a916-f51ce6713b3e 0574-4102 HUMAN PRESCRIPTION DRUG gentamicin sulfate gentamicin sulfate OINTMENT OPHTHALMIC 20131212 ANDA ANDA065024 Paddock Laboratories, LLC GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0574-4103_666ffd1b-e62d-4d74-bd69-c40391ddc76e 0574-4103 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin and Polymyxin B Sulfates and Hydrocortisone SUSPENSION AURICULAR (OTIC) 20080513 ANDA ANDA065219 Perrigo Company HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0574-4160_c8ae4afe-4f06-4441-9c5b-52f485f8f2f5 0574-4160 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin, Polymyxin B Sulfates, Dexamethasone OINTMENT OPHTHALMIC 20140703 ANDA ANDA062938 Paddock Laboratories, LLC DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 0574-4190_558280c6-893e-4645-9018-40c69be936d3 0574-4190 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium OINTMENT OPHTHALMIC 20140813 ANDA ANDA080029 Paddock Laboratories, LLC SULFACETAMIDE SODIUM 100 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0574-7034_cce244aa-cd79-49c8-b68e-267f2bd0ef67 0574-7034 HUMAN OTC DRUG aspirin aspirin SUPPOSITORY RECTAL 19900901 OTC MONOGRAPH NOT FINAL part343 Paddock Laboratories, LLC ASPIRIN 300 mg/1 0574-7036_cce244aa-cd79-49c8-b68e-267f2bd0ef67 0574-7036 HUMAN OTC DRUG aspirin aspirin SUPPOSITORY RECTAL 19900901 OTC MONOGRAPH NOT FINAL part343 Paddock Laboratories, LLC ASPIRIN 600 mg/1 0574-7040_e1e6a959-3d6d-46e6-b0fe-c5d6166ef440 0574-7040 HUMAN PRESCRIPTION DRUG Belladonna and Opium ATROPA BELLADONNA and OPIUM SUPPOSITORY RECTAL 19970422 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC ATROPA BELLADONNA; OPIUM 16.2; 30 mg/1; mg/1 CII 0574-7045_e1e6a959-3d6d-46e6-b0fe-c5d6166ef440 0574-7045 HUMAN PRESCRIPTION DRUG Belladonna and Opium ATROPA BELLADONNA and OPIUM SUPPOSITORY RECTAL 19940501 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC ATROPA BELLADONNA; OPIUM 16.2; 60 mg/1; mg/1 CII 0574-7050_7eada0fc-5f83-43da-a56f-b0f537298208 0574-7050 HUMAN OTC DRUG Bisacodyl bisacodyl SUPPOSITORY RECTAL 19900901 OTC MONOGRAPH NOT FINAL part334 Paddock Laboratories, LLC BISACODYL 10 mg/1 0574-7090_ddc26de3-4e5e-418a-b6db-5af37842d6a7 0574-7090 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 19900701 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0574-7093_c47f2d23-f2d7-43ad-899c-356d3b3dabfd 0574-7093 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 20030707 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC HYDROCORTISONE ACETATE 30 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0574-7110_b0ec4a93-09c4-43eb-a02b-0e258fbc618c 0574-7110 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE SUPPOSITORY RECTAL 19900901 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC MORPHINE SULFATE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0574-7112_b0ec4a93-09c4-43eb-a02b-0e258fbc618c 0574-7112 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE SUPPOSITORY RECTAL 19900901 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC MORPHINE SULFATE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0574-7114_b0ec4a93-09c4-43eb-a02b-0e258fbc618c 0574-7114 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE SUPPOSITORY RECTAL 19900901 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0574-7116_b0ec4a93-09c4-43eb-a02b-0e258fbc618c 0574-7116 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE SUPPOSITORY RECTAL 19900901 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0574-7224_386c81ac-bf28-4ede-9055-623644d8d832 0574-7224 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE SUPPOSITORY RECTAL 19960131 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC HYDROMORPHONE HYDROCHLORIDE 3 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0574-7226_d25e4e58-479b-4e03-9c65-c64f6683056f 0574-7226 HUMAN PRESCRIPTION DRUG Compro PROCHLORPERAZINE SUPPOSITORY RECTAL 20000901 ANDA ANDA040246 Paddock Laboratories, LLC PROCHLORPERAZINE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0574-7234_95c548b7-f8f1-4fab-9422-573f08945636 0574-7234 HUMAN PRESCRIPTION DRUG PHENADOZ Promethazine Hydrochloride SUPPOSITORY RECTAL 20030624 ANDA ANDA040479 Paddock Laboratories, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0574-7236_95c548b7-f8f1-4fab-9422-573f08945636 0574-7236 HUMAN PRESCRIPTION DRUG PHENADOZ Promethazine Hydrochloride SUPPOSITORY RECTAL 20030624 ANDA ANDA040479 Paddock Laboratories, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0574-9119_8c08a567-d7ee-4f8b-847e-00dbeb6decdb 0574-9119 HUMAN OTC DRUG compound benzoin compound benzoin TINCTURE TOPICAL 20140402 OTC MONOGRAPH NOT FINAL part356 Paddock Laboratories, LLC BENZOIN RESIN 100 mg/mL 0574-9838_456ee8f5-3e49-4b22-9c4b-6d7bd4adec53 0574-9838 HUMAN PRESCRIPTION DRUG desloratadine desloratadine TABLET, FILM COATED ORAL 20140110 ANDA ANDA078361 Paddock Laboratories, LLC DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0575-6200_a3b2758d-fb45-4888-b2bf-e725d518bbd5 0575-6200 HUMAN PRESCRIPTION DRUG Proglycem diazoxide SUSPENSION ORAL 19760528 NDA NDA017453 Teva Global Respiratory Research LLC DIAZOXIDE 50 mg/mL 0590-0324_ce5872de-db49-4355-a01f-c956447ee8c0 0590-0324 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090101 NDA NDA009218 Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company WARFARIN SODIUM 2 mg/mL Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0591-0149_38cccb75-fcf0-4270-ad25-7b580e0c3e26 0591-0149 HUMAN PRESCRIPTION DRUG Sodium Ferric Gluconate Complex Sodium Ferric Gluconate Complex INJECTION INTRAVENOUS 20110331 ANDA ANDA078215 Watson Laboratories, Inc. SODIUM FERRIC GLUCONATE COMPLEX 12.5 mg/mL 0591-0240_e6c2fdaa-d80a-4bcd-932c-0d4de23dfe34 0591-0240 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072926 Watson Laboratories, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0591-0241_e6c2fdaa-d80a-4bcd-932c-0d4de23dfe34 0591-0241 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 Watson Laboratories, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0591-0242_e6c2fdaa-d80a-4bcd-932c-0d4de23dfe34 0591-0242 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072928 Watson Laboratories, Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0591-0338_1a0ac4fa-38db-4432-a9c3-5b53b26ea45a 0591-0338 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 20150228 ANDA ANDA075185 Watson Pharma, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0591-0339_1a0ac4fa-38db-4432-a9c3-5b53b26ea45a 0591-0339 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 20150228 ANDA ANDA075185 Watson Pharma, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0591-0343_79180e04-6f83-475e-9ba2-fd91e70a622b 0591-0343 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070995 Watson Laboratories, Inc. VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0591-0345_79180e04-6f83-475e-9ba2-fd91e70a622b 0591-0345 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070994 Watson Laboratories, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0591-0347_79055d37-a4a3-435c-9c14-75436ea1a225 0591-0347 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 19961227 NDA AUTHORIZED GENERIC NDA020504 Watson Laboratories, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0591-0348_5fab9f18-163d-4287-9d37-fba9f4fecf66 0591-0348 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA071851 Watson Laboratories, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0591-0349_44aff119-8abd-40c3-b52f-43d9420d0a26 0591-0349 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19881201 20150831 ANDA ANDA089883 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0591-0369_03bc7ef3-cb62-4307-ac1a-eb757e6f9d89 0591-0369 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 19880615 ANDA ANDA072204 Watson Laboratories, Inc. LOXAPINE SUCCINATE 5 mg/1 0591-0370_03bc7ef3-cb62-4307-ac1a-eb757e6f9d89 0591-0370 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 19880615 ANDA ANDA072205 Watson Laboratories, Inc. LOXAPINE SUCCINATE 10 mg/1 0591-0371_03bc7ef3-cb62-4307-ac1a-eb757e6f9d89 0591-0371 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 19880615 ANDA ANDA072206 Watson Laboratories, Inc. LOXAPINE SUCCINATE 25 mg/1 0591-0372_03bc7ef3-cb62-4307-ac1a-eb757e6f9d89 0591-0372 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 19880615 ANDA ANDA072062 Watson Laboratories, Inc. LOXAPINE SUCCINATE 50 mg/1 0591-0385_44aff119-8abd-40c3-b52f-43d9420d0a26 0591-0385 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19910830 20150930 ANDA ANDA081080 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0591-0387_44aff119-8abd-40c3-b52f-43d9420d0a26 0591-0387 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19910830 20150930 ANDA ANDA081083 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0591-0388_44aff119-8abd-40c3-b52f-43d9420d0a26 0591-0388 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19910830 20150831 ANDA ANDA081079 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0591-0395_e802b1c3-ad62-4fd8-b2c3-5d42faabc602 0591-0395 HUMAN PRESCRIPTION DRUG Pentazocine and naloxone Pentazocine hydrochloride and naloxone hydrochloride TABLET ORAL 19970121 ANDA ANDA074736 Watson Laboratories, Inc. NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE .5; 50 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIV 0591-0396_28d5b43c-ecf2-41a3-8df4-04a2ec4b1296 0591-0396 HUMAN PRESCRIPTION DRUG Pentazocine HCl and Acetaminophen Pentazocine HCl and Acetaminophen TABLET ORAL 20000324 ANDA ANDA074699 Watson Laboratories, Inc. ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE 650; 25 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV 0591-0397_96e53997-3a41-4786-b637-906106b41cac 0591-0397 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20121101 ANDA ANDA201089 Watson Laboratories, Inc. DICLOFENAC SODIUM; MISOPROSTOL 50; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 0591-0398_96e53997-3a41-4786-b637-906106b41cac 0591-0398 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20121101 ANDA ANDA201089 Watson Laboratories, Inc. DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 0591-0404_79180e04-6f83-475e-9ba2-fd91e70a622b 0591-0404 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19930629 ANDA ANDA072924 Watson Laboratories, Inc. VERAPAMIL HYDROCHLORIDE 40 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0591-0405_cff3b8a6-af4f-4b90-9dd1-4c02152069d4 0591-0405 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Watson Laboratories, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0591-0406_cff3b8a6-af4f-4b90-9dd1-4c02152069d4 0591-0406 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Watson Laboratories, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0591-0407_cff3b8a6-af4f-4b90-9dd1-4c02152069d4 0591-0407 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Watson Laboratories, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0591-0408_cff3b8a6-af4f-4b90-9dd1-4c02152069d4 0591-0408 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Watson Laboratories, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0591-0409_cff3b8a6-af4f-4b90-9dd1-4c02152069d4 0591-0409 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Watson Laboratories, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0591-0410_7a3feb35-7b33-474b-9203-69ab06847494 0591-0410 HUMAN PRESCRIPTION DRUG Doxycycline Monohydrate Doxycycline CAPSULE ORAL 20050207 NDA AUTHORIZED GENERIC NDA050641 Actavis Pharma, Inc. DOXYCYCLINE 50 mg/1 0591-0411_7a3feb35-7b33-474b-9203-69ab06847494 0591-0411 HUMAN PRESCRIPTION DRUG Doxycycline Monohydrate Doxycycline CAPSULE ORAL 20050207 NDA AUTHORIZED GENERIC NDA050641 Actavis Pharma, Inc. DOXYCYCLINE 100 mg/1 0591-0414_cc22cec3-e76a-4ce2-8128-f269540d9149 0591-0414 HUMAN PRESCRIPTION DRUG Estropipate Estropipate TABLET ORAL 19930923 ANDA ANDA081213 Watson Laboratories, Inc. ESTROPIPATE .75 mg/1 0591-0415_cc22cec3-e76a-4ce2-8128-f269540d9149 0591-0415 HUMAN PRESCRIPTION DRUG Estropipate Estropipate TABLET ORAL 19930923 ANDA ANDA081214 Watson Laboratories, Inc. ESTROPIPATE 1.5 mg/1 0591-0416_cc22cec3-e76a-4ce2-8128-f269540d9149 0591-0416 HUMAN PRESCRIPTION DRUG Estropipate Estropipate TABLET ORAL 19930923 ANDA ANDA081215 Watson Laboratories, Inc. ESTROPIPATE 3 mg/1 0591-0424_5fab9f18-163d-4287-9d37-fba9f4fecf66 0591-0424 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA073449 Watson Laboratories, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0591-0426_16a6aedf-0bb5-493b-ac9e-7146f4ae51fd 0591-0426 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid SOLUTION ORAL 19950113 ANDA ANDA074060 Watson Laboratories, Inc. VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0591-0444_b6d09eb1-7490-4c39-9da7-d642f3f893bc 0591-0444 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 19951017 ANDA ANDA074145 Actavis Pharma, Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0591-0453_b6d09eb1-7490-4c39-9da7-d642f3f893bc 0591-0453 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 19951017 ANDA ANDA074145 Actavis Pharma, Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0591-0460_2be325b9-d702-4fa4-8d6e-0a85dad3c12f 0591-0460 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Watson Laboratories, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0591-0461_2be325b9-d702-4fa4-8d6e-0a85dad3c12f 0591-0461 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Watson Laboratories, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0591-0462_6ba1cfa6-5a2e-43d3-b705-47862ba71bec 0591-0462 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19940527 ANDA ANDA074217 Watson Laboratories, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0591-0463_6ba1cfa6-5a2e-43d3-b705-47862ba71bec 0591-0463 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19940527 ANDA ANDA074217 Watson Laboratories, Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0591-0487_d07653bc-a753-4349-98bf-306766022db1 0591-0487 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Watson Laboratories, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0591-0488_d07653bc-a753-4349-98bf-306766022db1 0591-0488 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Watson Laboratories, Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0591-0502_44aff119-8abd-40c3-b52f-43d9420d0a26 0591-0502 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19950929 20150131 ANDA ANDA040094 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0591-0503_44aff119-8abd-40c3-b52f-43d9420d0a26 0591-0503 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19950929 20150131 ANDA ANDA040094 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0591-0517_44aff119-8abd-40c3-b52f-43d9420d0a26 0591-0517 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20000808 20150331 ANDA ANDA040094 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 660; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0591-0528_d07653bc-a753-4349-98bf-306766022db1 0591-0528 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Watson Laboratories, Inc. ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0591-0582_6e47c7a7-6934-4a2f-9a75-11116de30e98 0591-0582 HUMAN PRESCRIPTION DRUG Propafenone HCl Propafenone hydrochloride TABLET, FILM COATED ORAL 20001024 ANDA ANDA075203 Watson Laboratories, Inc. PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] 0591-0583_6e47c7a7-6934-4a2f-9a75-11116de30e98 0591-0583 HUMAN PRESCRIPTION DRUG Propafenone HCl Propafenone hydrochloride TABLET, FILM COATED ORAL 20001024 ANDA ANDA075203 Watson Laboratories, Inc. PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] 0591-0605_79055602-a961-47a5-a44e-e02f09bbce06 0591-0605 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Watson Laboratories, Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0591-0606_79055602-a961-47a5-a44e-e02f09bbce06 0591-0606 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Watson Laboratories, Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0591-0607_79055602-a961-47a5-a44e-e02f09bbce06 0591-0607 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Watson Laboratories, Inc. LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0591-0657_6ef976dc-f439-4080-93f5-7e0c2e795bc9 0591-0657 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Watson Laboratories, Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 0591-0658_6ef976dc-f439-4080-93f5-7e0c2e795bc9 0591-0658 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Watson Laboratories, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 0591-0676_f2b375f8-4a4f-4669-b096-2d2ff9ace7c9 0591-0676 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021106 ANDA ANDA076201 Watson Laboratories, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0591-0698_c09f286f-2d0d-4946-ae7b-29c64c33b5a2 0591-0698 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, COATED ORAL 19951130 ANDA ANDA040133 Watson Laboratories, Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 0591-0718_6ef976dc-f439-4080-93f5-7e0c2e795bc9 0591-0718 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Watson Laboratories, Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 0591-0737_e0af1c2e-6963-4c40-8d57-ce39fa3f36f0 0591-0737 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen CAPSULE ORAL 19971030 ANDA ANDA040234 Watson Laboratories, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-0744_0966c195-c68b-44fe-8316-5782e7f6f56d 0591-0744 HUMAN PRESCRIPTION DRUG Estazolam Estazolam TABLET ORAL 19970819 ANDA ANDA074818 Watson Laboratories, Inc. ESTAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0591-0745_0966c195-c68b-44fe-8316-5782e7f6f56d 0591-0745 HUMAN PRESCRIPTION DRUG Estazolam Estazolam TABLET ORAL 19970819 ANDA ANDA074818 Watson Laboratories, Inc. ESTAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0591-0749_bd2abe7a-808f-499e-889c-f4ed8c153353 0591-0749 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 19971030 ANDA ANDA040171 Watson Laboratories, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-0780_f614085f-8497-45b8-a0f4-452c4b72d2ec 0591-0780 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 19961101 NDA NDA018333 Watson Laboratories, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 0591-0781_47e27311-3cbf-4e70-91d9-0fdfba29b878 0591-0781 HUMAN PRESCRIPTION DRUG clomiphene citrate clomiphene citrate TABLET ORAL 19940901 NDA NDA016131 Watson Laboratories, Inc. CLOMIPHENE CITRATE 50 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 0591-0782_ea48e26c-bc0f-4834-b60a-525a1f9b4647 0591-0782 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 19601117 NDA NDA012546 Actavis Pharma, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0591-0783_ea48e26c-bc0f-4834-b60a-525a1f9b4647 0591-0783 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Immediate-Release Diethylpropion hydrochloride TABLET ORAL 19590806 NDA NDA011722 Actavis Pharma, Inc. DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0591-0794_3ed3a2b2-cc00-453e-8a04-78fd6890236d 0591-0794 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 Actavis Pharma, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0591-0795_3ed3a2b2-cc00-453e-8a04-78fd6890236d 0591-0795 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19860730 ANDA ANDA085223 Actavis Pharma, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0591-0796_46c7c990-da20-442b-b147-f7da6272de45 0591-0796 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 19821001 ANDA ANDA085828 Watson Laboratories, Inc. SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 0591-0800_a6e94621-cbdb-415e-97e0-2708e66fe1f0 0591-0800 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 Watson Laboratories, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0591-0801_a6e94621-cbdb-415e-97e0-2708e66fe1f0 0591-0801 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960615 ANDA ANDA040156 Watson Laboratories, Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0591-0810_476ce2f8-e0a4-4b1c-bda8-21e7998b8dc2 0591-0810 HUMAN PRESCRIPTION DRUG Silver Sulfadiazene Silver Sulfadiazine CREAM TOPICAL 19820225 NDA NDA018578 Watson Laboratories, Inc. SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0591-0824_bd2abe7a-808f-499e-889c-f4ed8c153353 0591-0824 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20001229 ANDA ANDA040371 Watson Laboratories, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-0825_bd2abe7a-808f-499e-889c-f4ed8c153353 0591-0825 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20001229 ANDA ANDA040371 Watson Laboratories, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 650; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-0844_f25229b5-ea7b-42b8-9691-7b96f9b7ceec 0591-0844 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031101 ANDA ANDA076467 Watson Laboratories, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0591-0845_f25229b5-ea7b-42b8-9691-7b96f9b7ceec 0591-0845 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031107 ANDA ANDA076467 Watson Laboratories, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0591-0860_889153a2-b6fd-4858-8851-6192ab39244d 0591-0860 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20030301 ANDA ANDA076194 Watson Laboratories, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0591-0861_889153a2-b6fd-4858-8851-6192ab39244d 0591-0861 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20030301 ANDA ANDA076194 Watson Laboratories, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0591-0862_889153a2-b6fd-4858-8851-6192ab39244d 0591-0862 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20030301 ANDA ANDA076194 Watson Laboratories, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0591-0885_cff3b8a6-af4f-4b90-9dd1-4c02152069d4 0591-0885 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Watson Laboratories, Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0591-0900_f25229b5-ea7b-42b8-9691-7b96f9b7ceec 0591-0900 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060401 ANDA ANDA076467 Watson Laboratories, Inc. GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0591-0932_bd2abe7a-808f-499e-889c-f4ed8c153353 0591-0932 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20030905 ANDA ANDA040535 Watson Laboratories, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-0933_bd2abe7a-808f-499e-889c-f4ed8c153353 0591-0933 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20030905 ANDA ANDA040535 Watson Laboratories, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-1117_f8a1f443-a896-4014-87df-fd054928e874 0591-1117 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076312 Actavis Pharma, Inc. MIRTAZAPINE 15 mg/1 0591-1118_f8a1f443-a896-4014-87df-fd054928e874 0591-1118 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076312 Actavis Pharma, Inc. MIRTAZAPINE 30 mg/1 0591-1119_f8a1f443-a896-4014-87df-fd054928e874 0591-1119 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076312 Actavis Pharma, Inc. MIRTAZAPINE 45 mg/1 0591-1159_a285e2bc-3622-43f6-be37-81f701a84bf1 0591-1159 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir OINTMENT TOPICAL 20140411 NDA AUTHORIZED GENERIC NDA018604 Watson Laboratories, Inc ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0591-2044_e87b3955-8563-4fda-9b18-b1a2bd6ea061 0591-2044 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20140627 NDA AUTHORIZED GENERIC NDA020835 Actavis Pharma, Inc. RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 129; 21 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0591-2067_e87b3955-8563-4fda-9b18-b1a2bd6ea061 0591-2067 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20140627 NDA AUTHORIZED GENERIC NDA020835 Actavis Pharma, Inc. RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 64.5; 10.5 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0591-2070_e885b52f-3acc-45b9-8a44-4c6e675150b5 0591-2070 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine lidocaine and prilocaine CREAM TOPICAL 20121112 NDA AUTHORIZED GENERIC NDA019941 Actavis Pharma, Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0591-2075_e87b3955-8563-4fda-9b18-b1a2bd6ea061 0591-2075 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20140627 NDA AUTHORIZED GENERIC NDA020835 Actavis Pharma, Inc. RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 30.1; 4.9 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0591-2102_e87b3955-8563-4fda-9b18-b1a2bd6ea061 0591-2102 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20140627 NDA AUTHORIZED GENERIC NDA020835 Actavis Pharma, Inc. RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 4.3; .7 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0591-2109_e87b3955-8563-4fda-9b18-b1a2bd6ea061 0591-2109 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20140627 NDA AUTHORIZED GENERIC NDA020835 Actavis Pharma, Inc. RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 25.8; 4.2 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0591-2157_df534055-c02c-41e9-a81c-72ed70eff9e4 0591-2157 HUMAN PRESCRIPTION DRUG AMMONIUM LACTATE AMMONIUM LACTATE CREAM TOPICAL 20120605 ANDA ANDA075774 Watson Laboratories, Inc. AMMONIUM LACTATE 12 g/100g 0591-2158_08a1e7fb-3d1d-462f-ae8e-299f4733cfc5 0591-2158 HUMAN PRESCRIPTION DRUG Ammonium Lactate Ammonium Lactate LOTION TOPICAL 20120605 ANDA ANDA075570 Watson Laboratories, Inc. AMMONIUM LACTATE 12 g/100g 0591-2159_5458190f-b0c9-4ea2-81e8-a5b91d3d2285 0591-2159 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SHAMPOO TOPICAL 20121212 ANDA ANDA090490 Watson Laboratories, Inc. CICLOPIROX 10 mg/.96mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 0591-2160_0cab4c41-251b-492e-91a3-19c945fbccd0 0591-2160 HUMAN PRESCRIPTION DRUG PHENADOZ Promethazine Hydrochloride SUPPOSITORY RECTAL 20130212 ANDA ANDA040479 Watson Laboratories, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0591-2161_0cab4c41-251b-492e-91a3-19c945fbccd0 0591-2161 HUMAN PRESCRIPTION DRUG PHENADOZ Promethazine Hydrochloride SUPPOSITORY RECTAL 20130403 ANDA ANDA040479 Watson Laboratories, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0591-2171_4c412923-49f7-4a15-837a-f1402a7ad0e0 0591-2171 HUMAN PRESCRIPTION DRUG Hydrocodone Bitatrate and Acetaminophen Hydrocodone Bitatrate and Acetaminophen TABLET ORAL 20141006 ANDA ANDA040148 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0591-2190_fcad3af1-37ba-4f76-982d-713b266803b2 0591-2190 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates Neomycin and Polymyxin B Sulfates IRRIGANT IRRIGATION 20101025 ANDA ANDA062664 Watson Laboratories, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE 40; 200000 mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 0591-2222_c0769076-ffc5-456d-a175-2fec43e7a66d 0591-2222 HUMAN PRESCRIPTION DRUG CycloSPORINE CycloSPORINE CAPSULE, LIQUID FILLED ORAL 20081201 ANDA ANDA065044 Watson Laboratories, Inc. CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0591-2223_c0769076-ffc5-456d-a175-2fec43e7a66d 0591-2223 HUMAN PRESCRIPTION DRUG CycloSPORINE CycloSPORINE CAPSULE, LIQUID FILLED ORAL 20081201 ANDA ANDA065044 Watson Laboratories, Inc. CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0591-2224_c0769076-ffc5-456d-a175-2fec43e7a66d 0591-2224 HUMAN PRESCRIPTION DRUG CycloSPORINE CycloSPORINE SOLUTION ORAL 20081201 ANDA ANDA065054 Watson Laboratories, Inc. CYCLOSPORINE 100 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0591-2231_deb3d7f7-0003-4610-99df-07604ed6993c 0591-2231 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20081201 20150131 ANDA ANDA076307 Watson Laboratories, Inc. MIRTAZAPINE 30 mg/1 0591-2281_b0be7690-369d-482b-b3d7-422a1f147db1 0591-2281 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130325 ANDA ANDA090153 Watson Laboratories, Inc. ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0591-2282_b0be7690-369d-482b-b3d7-422a1f147db1 0591-2282 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130325 ANDA ANDA090153 Watson Laboratories, Inc. ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0591-2315_cd2a4ba2-a464-42bc-bfdc-f9a3db89e480 0591-2315 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA091519 Watson Laboratories, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0591-2316_cd2a4ba2-a464-42bc-bfdc-f9a3db89e480 0591-2316 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA091519 Watson Laboratories, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0591-2317_cd2a4ba2-a464-42bc-bfdc-f9a3db89e480 0591-2317 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA091519 Watson Laboratories, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0591-2318_cd2a4ba2-a464-42bc-bfdc-f9a3db89e480 0591-2318 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA091519 Watson Laboratories, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0591-2319_cd2a4ba2-a464-42bc-bfdc-f9a3db89e480 0591-2319 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA091519 Watson Laboratories, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0591-2368_e5a0f8bb-5a4c-4a16-82a8-a8117f02b7ca 0591-2368 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET, FILM COATED ORAL 20111223 ANDA ANDA200826 Actavis Pharma, Inc. URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 0591-2369_e5a0f8bb-5a4c-4a16-82a8-a8117f02b7ca 0591-2369 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET, FILM COATED ORAL 20111223 ANDA ANDA200826 Actavis Pharma, Inc. URSODIOL 500 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 0591-2404_7a3feb35-7b33-474b-9203-69ab06847494 0591-2404 HUMAN PRESCRIPTION DRUG Doxycycline Monohydrate Doxycycline CAPSULE ORAL 20110207 NDA AUTHORIZED GENERIC NDA050641 Actavis Pharma, Inc. DOXYCYCLINE 75 mg/1 0591-2464_8c5fd44e-8a70-494d-8482-185bb58446d7 0591-2464 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20110815 ANDA ANDA076470 Watson Laboratories, Inc. DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 0591-2465_8c5fd44e-8a70-494d-8482-185bb58446d7 0591-2465 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20110815 ANDA ANDA076470 Watson Laboratories, Inc. DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 0591-2466_66ff2513-7f4d-4e99-a1b8-07c3741108d8 0591-2466 HUMAN PRESCRIPTION DRUG Flutamide Flutamide CAPSULE ORAL 20110728 ANDA ANDA075820 Watson Laboratories, Inc. FLUTAMIDE 125 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 0591-2467_90e71de2-fcb7-4925-a654-26648d697709 0591-2467 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA072750 Watson Laboratories, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0591-2468_90e71de2-fcb7-4925-a654-26648d697709 0591-2468 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA071250 Watson Laboratories, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0591-2469_c9403834-9cdf-42dd-b8c3-edfe48b661fb 0591-2469 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20140211 ANDA ANDA076307 Actavis Pharma, Inc. MIRTAZAPINE 15 mg/1 0591-2470_c9403834-9cdf-42dd-b8c3-edfe48b661fb 0591-2470 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20140211 ANDA ANDA076307 Actavis Pharma, Inc. MIRTAZAPINE 30 mg/1 0591-2471_c9403834-9cdf-42dd-b8c3-edfe48b661fb 0591-2471 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20141113 ANDA ANDA076307 Actavis Pharma, Inc. MIRTAZAPINE 45 mg/1 0591-2472_dae37822-4738-4918-8370-aa01a776ec03 0591-2472 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20110815 ANDA ANDA070929 Watson Laboratories, Inc. TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 0591-2473_dae37822-4738-4918-8370-aa01a776ec03 0591-2473 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20110815 ANDA ANDA070929 Watson Laboratories, Inc. TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 0591-2474_e7d93e84-7a4b-48bf-a4bb-6bc1996adea9 0591-2474 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20110815 ANDA ANDA061837 Watson Laboratories, Inc. TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 0591-2475_e7d93e84-7a4b-48bf-a4bb-6bc1996adea9 0591-2475 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20110815 ANDA ANDA061837 Watson Laboratories, Inc. TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 0591-2508_48be19d6-c73a-4d2e-8655-8e8a25c91659 0591-2508 HUMAN PRESCRIPTION DRUG Sodium Ferric Gluconate Complex in Sucrose Sodium Ferric Gluconate Complex INJECTION INTRAVENOUS 20120823 ANDA ANDA078215 Watson Laboratories, Inc. SODIUM FERRIC GLUCONATE COMPLEX 12.5 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 0591-2520_3732a182-d7f3-48d3-afc6-1db6a349190c 0591-2520 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822 ANDA ANDA089859 Watson Laboratories, Inc. CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0591-2521_155b5133-c92a-4836-ae26-2e91cf2ce9cf 0591-2521 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110822 ANDA ANDA070035 Actavis Pharma, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0591-2522_155b5133-c92a-4836-ae26-2e91cf2ce9cf 0591-2522 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110822 20160831 ANDA ANDA070044 Actavis Pharma, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0591-2605_1a6ad04b-6fdb-4f36-bff6-871eb2447c22 0591-2605 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130314 ANDA ANDA040148 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0591-2607_44aff119-8abd-40c3-b52f-43d9420d0a26 0591-2607 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130423 20150731 ANDA ANDA040094 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0591-2609_44aff119-8abd-40c3-b52f-43d9420d0a26 0591-2609 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130104 20150930 ANDA ANDA040148 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0591-2610_44aff119-8abd-40c3-b52f-43d9420d0a26 0591-2610 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130314 20150930 ANDA ANDA040094 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0591-2611_44aff119-8abd-40c3-b52f-43d9420d0a26 0591-2611 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130415 20150731 ANDA ANDA040094 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0591-2612_1a6ad04b-6fdb-4f36-bff6-871eb2447c22 0591-2612 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130307 ANDA ANDA040148 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0591-2640_28ec7c48-977f-4c10-930c-a12d009f705f 0591-2640 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine CAPSULE ORAL 20130729 ANDA ANDA040885 Actavis Pharma, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 300; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 0591-2641_5cbba5c1-e037-46bf-a4ed-6cc01c5154da 0591-2641 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE ORAL 20130729 ANDA ANDA076560 Actavis Pharma, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 300; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0591-2679_fe739dcd-3f4d-48a4-be1d-5f522e4ed78a 0591-2679 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine PATCH CUTANEOUS 20140626 ANDA ANDA200675 Actavis Pharma, Inc. LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0591-2693_f58a7973-696c-4c3c-b7d4-145f838d7c81 0591-2693 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140903 NDA AUTHORIZED GENERIC NDA022272 Actavis Pharma, Inc. OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-2708_f58a7973-696c-4c3c-b7d4-145f838d7c81 0591-2708 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140903 NDA AUTHORIZED GENERIC NDA022272 Actavis Pharma, Inc. OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-2715_a0c634c8-2514-43bf-84da-8e3b7a61f197 0591-2715 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride TABLET ORAL 20110401 NDA AUTHORIZED GENERIC NDA021121 Actavis Pharma, Inc. METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0591-2716_a0c634c8-2514-43bf-84da-8e3b7a61f197 0591-2716 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride TABLET ORAL 20110401 NDA AUTHORIZED GENERIC NDA021121 Actavis Pharma, Inc. METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0591-2717_a0c634c8-2514-43bf-84da-8e3b7a61f197 0591-2717 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride TABLET ORAL 20110401 NDA AUTHORIZED GENERIC NDA021121 Actavis Pharma, Inc. METHYLPHENIDATE HYDROCHLORIDE 36 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0591-2718_a0c634c8-2514-43bf-84da-8e3b7a61f197 0591-2718 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride TABLET ORAL 20110401 NDA AUTHORIZED GENERIC NDA021121 Actavis Pharma, Inc. METHYLPHENIDATE HYDROCHLORIDE 54 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0591-2719_2e766da9-7fe2-4b4e-82b2-a2df2823790d 0591-2719 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120418 NDA NDA021574 Watson Laboratories, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0591-2720_2e766da9-7fe2-4b4e-82b2-a2df2823790d 0591-2720 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120418 NDA NDA021574 Watson Laboratories, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0591-2736_d2bddc42-7768-4b27-a872-cfc5c5a93f89 0591-2736 HUMAN PRESCRIPTION DRUG levalbuterol hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20140610 ANDA ANDA077756 Actavis Pharma, Inc. LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0591-2737_d2bddc42-7768-4b27-a872-cfc5c5a93f89 0591-2737 HUMAN PRESCRIPTION DRUG levalbuterol hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20140610 ANDA ANDA077756 Actavis Pharma, Inc. LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0591-2738_d2bddc42-7768-4b27-a872-cfc5c5a93f89 0591-2738 HUMAN PRESCRIPTION DRUG levalbuterol hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20140610 ANDA ANDA077756 Actavis Pharma, Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0591-2782_6606acd1-e7e6-4dac-a031-187a888d3cf6 0591-2782 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET, COATED ORAL 20121016 ANDA ANDA090720 Watson Laboratories, Inc. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0591-2783_6606acd1-e7e6-4dac-a031-187a888d3cf6 0591-2783 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET, COATED ORAL 20121016 ANDA ANDA090720 Watson Laboratories, Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0591-2784_6606acd1-e7e6-4dac-a031-187a888d3cf6 0591-2784 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET, COATED ORAL 20121016 ANDA ANDA090720 Watson Laboratories, Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0591-2785_29e642ce-ac10-46e2-be86-ccd5c9521306 0591-2785 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20121022 ANDA ANDA091539 Watson Laboratories, Inc. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0591-2786_29e642ce-ac10-46e2-be86-ccd5c9521306 0591-2786 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20121022 ANDA ANDA091539 Watson Laboratories, Inc. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0591-2788_55ff120b-6e6d-46cc-a814-444b3289d97e 0591-2788 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 NDA NDA021447 Watson Laboratories, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0591-2789_55ff120b-6e6d-46cc-a814-444b3289d97e 0591-2789 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 NDA NDA021447 Watson Laboratories, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0591-2790_55ff120b-6e6d-46cc-a814-444b3289d97e 0591-2790 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 NDA NDA021447 Watson Laboratories, Inc. TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0591-2805_874dedce-0c92-4a99-91ec-bfabccfcc552 0591-2805 HUMAN PRESCRIPTION DRUG clarithromycin clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080101 ANDA ANDA065145 Watson Laboratories, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0591-2817_e9af2e8a-347f-45e1-9c43-d76d5bbf8043 0591-2817 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Actavis Pharma, Inc. CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0591-2820_e9af2e8a-347f-45e1-9c43-d76d5bbf8043 0591-2820 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Actavis Pharma, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0591-2825_e9af2e8a-347f-45e1-9c43-d76d5bbf8043 0591-2825 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Actavis Pharma, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0591-2831_e9af2e8a-347f-45e1-9c43-d76d5bbf8043 0591-2831 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Actavis Pharma, Inc. CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0591-2880_c6f3be6e-3605-4ca5-823b-51a56bd5732a 0591-2880 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Actavis Pharma, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0591-2882_c6f3be6e-3605-4ca5-823b-51a56bd5732a 0591-2882 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Actavis Pharma, Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0591-2884_c6f3be6e-3605-4ca5-823b-51a56bd5732a 0591-2884 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Actavis Pharma, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0591-2886_c6f3be6e-3605-4ca5-823b-51a56bd5732a 0591-2886 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Actavis Pharma, Inc. VERAPAMIL HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0591-2888_8a32969f-18b7-4a22-8566-928b31b366f1 0591-2888 HUMAN PRESCRIPTION DRUG Hydroxocobalamin Hydroxocobalamin INJECTION, SOLUTION INTRAMUSCULAR 20101112 ANDA ANDA085998 Watson Laboratories, Inc. HYDROXOCOBALAMIN ACETATE 1000 ug/mL Antidote [EPC] 0591-2918_ceea2082-0de1-44da-8ed1-c0e693ba994c 0591-2918 HUMAN PRESCRIPTION DRUG levalbuterol hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20120820 NDA NDA020837 Watson Laboratories, Inc. LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0591-2919_ceea2082-0de1-44da-8ed1-c0e693ba994c 0591-2919 HUMAN PRESCRIPTION DRUG levalbuterol hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20120820 NDA NDA020837 Watson Laboratories, Inc. LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0591-2920_ceea2082-0de1-44da-8ed1-c0e693ba994c 0591-2920 HUMAN PRESCRIPTION DRUG levalbuterol hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20120820 NDA NDA020837 Watson Laboratories, Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0591-2932_0c4ee9d3-77b0-4656-8493-bcccc086e61a 0591-2932 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140909 ANDA ANDA063083 Actavis Pharma, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0591-2998_17a5c36f-f0fa-4f33-b9a5-5e26f17bd6a5 0591-2998 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET ORAL 19971210 NDA AUTHORIZED GENERIC NDA020675 Actavis Pharma, Inc. URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 0591-3005_17a5c36f-f0fa-4f33-b9a5-5e26f17bd6a5 0591-3005 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET ORAL 19971210 NDA AUTHORIZED GENERIC NDA020675 Actavis Pharma, Inc. URSODIOL 500 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 0591-3120_0c4ee9d3-77b0-4656-8493-bcccc086e61a 0591-3120 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20030318 20160331 ANDA ANDA063083 Actavis Pharma, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0591-3128_c2f49bb9-99c5-46d3-841a-3da017a61ecc 0591-3128 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE INJECTION, SOLUTION INTRAMUSCULAR 19780511 NDA NDA017362 Watson Laboratories, Inc. PROGESTERONE 50 mg/mL Progesterone [Chemical/Ingredient],Progesterone [EPC] 0591-3137_f921a43e-e8d0-492d-871a-cbc0bff2f23d 0591-3137 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20020709 ANDA ANDA075616 Watson Laboratories, Inc. NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0591-3138_f921a43e-e8d0-492d-871a-cbc0bff2f23d 0591-3138 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20020709 ANDA ANDA075616 Watson Laboratories, Inc. NIZATIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0591-3153_828dd059-0f04-4c64-9ad0-cb2437d9c307 0591-3153 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19990610 ANDA ANDA063065 Actavis Pharma, Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0591-3159_a2d604f6-c702-4343-8909-374b7b6b2a0b 0591-3159 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 19871231 NDA AUTHORIZED GENERIC NDA019594 Watson Laboratories, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 0591-3169_6174b26f-67a1-4a17-9544-d5bf8492abe9 0591-3169 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA076768 Watson Laboratories, Inc. ALENDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0591-3170_6174b26f-67a1-4a17-9544-d5bf8492abe9 0591-3170 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA076768 Watson Laboratories, Inc. ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0591-3171_6174b26f-67a1-4a17-9544-d5bf8492abe9 0591-3171 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA076768 Watson Laboratories, Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0591-3172_6174b26f-67a1-4a17-9544-d5bf8492abe9 0591-3172 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA076768 Watson Laboratories, Inc. ALENDRONATE SODIUM 40 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0591-3173_6174b26f-67a1-4a17-9544-d5bf8492abe9 0591-3173 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA076768 Watson Laboratories, Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0591-3193_d5d782fe-1222-435f-bc23-f256c354414a 0591-3193 HUMAN PRESCRIPTION DRUG Afeditab CR Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021101 ANDA ANDA075128 Watson Laboratories, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0591-3194_d5d782fe-1222-435f-bc23-f256c354414a 0591-3194 HUMAN PRESCRIPTION DRUG Afeditab CR Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021101 ANDA ANDA075659 Watson Laboratories, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0591-3196_f0617705-38d2-460b-a329-e916ca655e33 0591-3196 HUMAN PRESCRIPTION DRUG TERCONAZOLE TERCONAZOLE CREAM VAGINAL 20040401 NDA AUTHORIZED GENERIC NDA019579 Actavis Pharma, Inc TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0591-3197_f0617705-38d2-460b-a329-e916ca655e33 0591-3197 HUMAN PRESCRIPTION DRUG TERCONAZOLE TERCONAZOLE CREAM VAGINAL 20040401 NDA AUTHORIZED GENERIC NDA019964 Actavis Pharma, Inc TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 0591-3198_b10d9261-2861-4984-a05a-bc7c9292c70d 0591-3198 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Actavis Pharma, Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3202_cf53b11b-9eab-4a4c-b44b-e242be57a0ff 0591-3202 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen Hydrocodone Bitartate and Acetaminophen TABLET ORAL 19970625 ANDA ANDA040099 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0591-3204_3e4bc383-5e29-48b7-b55a-97a98a994d33 0591-3204 HUMAN PRESCRIPTION DRUG Podofilox Podofilox SOLUTION TOPICAL 19901213 NDA AUTHORIZED GENERIC NDA019795 Watson Laboratories, Inc. PODOFILOX 5 mg/mL Decreased Mitosis [PE] 0591-3205_c1481318-3e22-4778-bbab-99d38c5cb95f 0591-3205 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20121026 ANDA ANDA076798 Actavis Pharma, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0591-3206_c1481318-3e22-4778-bbab-99d38c5cb95f 0591-3206 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20121026 ANDA ANDA076798 Actavis Pharma, Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0591-3207_c1481318-3e22-4778-bbab-99d38c5cb95f 0591-3207 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20121026 ANDA ANDA076798 Actavis Pharma, Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0591-3208_7dccedda-967e-4967-b5c5-e4a90bbb738a 0591-3208 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077129 Watson Laboratories, Inc. RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0591-3209_7dccedda-967e-4967-b5c5-e4a90bbb738a 0591-3209 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077129 Watson Laboratories, Inc. RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0591-3210_7dccedda-967e-4967-b5c5-e4a90bbb738a 0591-3210 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077129 Watson Laboratories, Inc. RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0591-3211_7dccedda-967e-4967-b5c5-e4a90bbb738a 0591-3211 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077129 Watson Laboratories, Inc. RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0591-3212_b10d9261-2861-4984-a05a-bc7c9292c70d 0591-3212 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Actavis Pharma, Inc. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3213_b10d9261-2861-4984-a05a-bc7c9292c70d 0591-3213 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Actavis Pharma, Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3214_b10d9261-2861-4984-a05a-bc7c9292c70d 0591-3214 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Actavis Pharma, Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3219_19939b50-b3d9-4d27-9a41-f39a078ae46f 0591-3219 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, and Caffeine butalbital, aspirin, and caffeine CAPSULE ORAL 20031006 NDA AUTHORIZED GENERIC NDA017534 Actavis Pharma, Inc. ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 0591-3220_e9abddea-2c98-481f-9683-2cb690c5e5c0 0591-3220 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE ORAL 20031001 NDA AUTHORIZED GENERIC NDA020232 Actavis Pharma, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 0591-3221_c76d2fe4-0979-4f51-a509-6d1b088dada4 0591-3221 HUMAN PRESCRIPTION DRUG Testosterone Enanthate Testosterone Enanthate INJECTION, SOLUTION INTRAMUSCULAR 20110504 ANDA ANDA085598 Watson Laboratories, Inc. TESTOSTERONE ENANTHATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0591-3222_8c62c2ec-a15d-4dfc-b084-2ad39ddc27a3 0591-3222 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate INJECTION INTRAMUSCULAR; INTRAVENOUS 20100708 ANDA ANDA084779 Watson Laboratories, Inc. ORPHENADRINE CITRATE 30 mg/mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0591-3223_436a28df-bac0-4c1b-a879-d71c6c4d4c11 0591-3223 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20110504 ANDA ANDA086030 Watson Laboratories, Inc. TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0591-3248_c4bb08f5-a0dd-4302-b886-cc1cd04ca984 0591-3248 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA077135 Watson Laboratories, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0591-3249_c4bb08f5-a0dd-4302-b886-cc1cd04ca984 0591-3249 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA077135 Watson Laboratories, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0591-3256_8bd541af-7c73-4795-bfb0-a05232f0c20e 0591-3256 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20060203 ANDA ANDA071611 Watson Laboratories, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0591-3271_6543af08-c77d-4140-b726-7b4f8ee0bb9b 0591-3271 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA078278 Watson Laboratories, Inc. FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0591-3272_6543af08-c77d-4140-b726-7b4f8ee0bb9b 0591-3272 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA078278 Watson Laboratories, Inc. FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0591-3273_6543af08-c77d-4140-b726-7b4f8ee0bb9b 0591-3273 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA078278 Watson Laboratories, Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0591-3292_7574c18f-c2cc-4175-8462-f46351a84198 0591-3292 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20140108 ANDA ANDA078710 Actavis Pharma, Inc. TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0591-3293_7574c18f-c2cc-4175-8462-f46351a84198 0591-3293 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20140108 ANDA ANDA078710 Actavis Pharma, Inc. TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0591-3294_7574c18f-c2cc-4175-8462-f46351a84198 0591-3294 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20140108 ANDA ANDA078710 Actavis Pharma, Inc. TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0591-3330_8bd541af-7c73-4795-bfb0-a05232f0c20e 0591-3330 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20060203 ANDA ANDA071611 Watson Laboratories, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0591-3331_a55a76f0-7009-484d-b379-d47c2cc39b9c 0591-3331 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081126 ANDA ANDA077715 Watson Laboratories, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0591-3332_a55a76f0-7009-484d-b379-d47c2cc39b9c 0591-3332 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070613 ANDA ANDA077715 Watson Laboratories, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0591-3354_00295ca8-557f-4253-9624-533c06b28ae1 0591-3354 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET ORAL 20110330 ANDA ANDA077462 Watson Laboratories, Inc. NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0591-3355_00295ca8-557f-4253-9624-533c06b28ae1 0591-3355 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET ORAL 20110330 ANDA ANDA077462 Watson Laboratories, Inc. NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0591-3359_846c2bca-eedc-48d6-91e6-0cf871f32509 0591-3359 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20100706 ANDA ANDA090402 Watson Laboratories, Inc. TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0591-3369_00cdeebc-8d76-4535-9d61-13e776a942fd 0591-3369 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20071213 ANDA ANDA088616 Actavis Pharma, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0591-3423_956abfb6-ee22-42b2-9021-ae6f38a296e4 0591-3423 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20111121 ANDA ANDA088350 Watson Laboratories, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0591-3433_30878f6c-9bb4-4d48-b757-5ab1f258164f 0591-3433 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20071231 20150131 ANDA ANDA077559 Watson Laboratories, Inc. ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 2.5; .5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0591-3449_6e1cb452-4764-4040-b6f0-b312ff686f39 0591-3449 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Watson Laboratories, Inc. MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3450_6e1cb452-4764-4040-b6f0-b312ff686f39 0591-3450 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Watson Laboratories, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3451_6e1cb452-4764-4040-b6f0-b312ff686f39 0591-3451 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Watson Laboratories, Inc. MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3452_6e1cb452-4764-4040-b6f0-b312ff686f39 0591-3452 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Watson Laboratories, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3453_6e1cb452-4764-4040-b6f0-b312ff686f39 0591-3453 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Watson Laboratories, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3467_e6077957-568b-4277-8ec6-6c4c03599c72 0591-3467 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION INTRABRONCHIAL 20070925 ANDA ANDA077772 Watson Laboratories, Inc. ALBUTEROL SULFATE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0591-3468_e6077957-568b-4277-8ec6-6c4c03599c72 0591-3468 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION INTRABRONCHIAL 20070925 ANDA ANDA077772 Watson Laboratories, Inc. ALBUTEROL SULFATE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0591-3494_353286a1-f98c-48d5-a379-b324f370de33 0591-3494 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride and ibuprofen oxycodone hydrochloride and ibuprofen TABLET ORAL 20071201 ANDA ANDA078394 Watson Laboratories, Inc. IBUPROFEN; OXYCODONE HYDROCHLORIDE 400; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 0591-3496_241a824a-a025-4d92-b26c-c51e1d9db0f9 0591-3496 HUMAN PRESCRIPTION DRUG Galantamine hydrobromide Galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20091215 ANDA ANDA079028 Watson Laboratories, Inc. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0591-3497_241a824a-a025-4d92-b26c-c51e1d9db0f9 0591-3497 HUMAN PRESCRIPTION DRUG Galantamine hydrobromide Galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20091215 ANDA ANDA079028 Watson Laboratories, Inc. GALANTAMINE HYDROBROMIDE 16 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0591-3498_241a824a-a025-4d92-b26c-c51e1d9db0f9 0591-3498 HUMAN PRESCRIPTION DRUG Galantamine hydrobromide Galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20091215 ANDA ANDA079028 Watson Laboratories, Inc. GALANTAMINE HYDROBROMIDE 24 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0591-3499_59b96776-5473-41b2-91c3-a740677eaa5d 0591-3499 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20130403 ANDA ANDA076715 Actavis Pharma, Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 0591-3500_59b96776-5473-41b2-91c3-a740677eaa5d 0591-3500 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20130403 ANDA ANDA076715 Actavis Pharma, Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 0591-3508_51ecfc93-d751-4ca3-9db1-5a1e4b2b0629 0591-3508 HUMAN PRESCRIPTION DRUG Clonidine transdermal system Clonidine PATCH TRANSDERMAL 20140506 ANDA ANDA090873 Actavis Pharma, Inc. CLONIDINE .1 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0591-3509_51ecfc93-d751-4ca3-9db1-5a1e4b2b0629 0591-3509 HUMAN PRESCRIPTION DRUG Clonidine transdermal system Clonidine PATCH TRANSDERMAL 20140506 ANDA ANDA090873 Actavis Pharma, Inc. CLONIDINE .2 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0591-3510_51ecfc93-d751-4ca3-9db1-5a1e4b2b0629 0591-3510 HUMAN PRESCRIPTION DRUG Clonidine transdermal system Clonidine PATCH TRANSDERMAL 20140506 ANDA ANDA090873 Actavis Pharma, Inc. CLONIDINE .3 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0591-3525_e02bed42-6498-4fb9-9acd-a581da1bbda1 0591-3525 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine PATCH CUTANEOUS 20130915 ANDA ANDA200675 Watson Laboratories, Inc. LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0591-3540_b1fb7751-3dcc-45a3-ae6b-ac9f53f65fd4 0591-3540 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 Watson Laboratories, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0591-3541_b1fb7751-3dcc-45a3-ae6b-ac9f53f65fd4 0591-3541 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 Watson Laboratories, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0591-3542_b1fb7751-3dcc-45a3-ae6b-ac9f53f65fd4 0591-3542 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 Watson Laboratories, Inc. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0591-3543_8a1fdd6a-7da0-4f29-b6f1-41e3eb7e9f77 0591-3543 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090825 ANDA ANDA079094 Watson Laboratories, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0591-3544_74463f10-4123-4f16-bd59-29d234343193 0591-3544 HUMAN PRESCRIPTION DRUG oxandrolone oxandrolone TABLET ORAL 20070101 NDA NDA013718 Watson Laboratories, Inc. OXANDROLONE 2.5 mg/1 CIII 0591-3545_74463f10-4123-4f16-bd59-29d234343193 0591-3545 HUMAN PRESCRIPTION DRUG oxandrolone oxandrolone TABLET ORAL 20070101 NDA NDA013718 Watson Laboratories, Inc. OXANDROLONE 10 mg/1 CIII 0591-3546_5ffcd5c0-9fd7-467e-a947-5b6617289442 0591-3546 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, Caffeine and Codeine Phosphate Butalbital, Aspirin, Caffeine and Codeine Phosphate CAPSULE ORAL 20061026 NDA AUTHORIZED GENERIC NDA019429 Actavis Pharma, Inc. ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 0591-3551_c0684e99-a423-4e1e-bae9-67e325b95b91 0591-3551 HUMAN PRESCRIPTION DRUG Oxycodone and Aspirin Oxycodone and Aspirin TABLET ORAL 20111018 ANDA ANDA090084 Watson Laboratories, Inc. ASPIRIN; OXYCODONE HYDROCHLORIDE 325; 4.8355 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 0591-3560_5422685c-f6f5-4c20-95e7-d75a43e738ad 0591-3560 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride CAPSULE ORAL 20120409 ANDA ANDA065510 Watson Laboratories, Inc. VANCOMYCIN HYDROCHLORIDE 125 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0591-3561_5422685c-f6f5-4c20-95e7-d75a43e738ad 0591-3561 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride CAPSULE ORAL 20120409 ANDA ANDA065510 Watson Laboratories, Inc. VANCOMYCIN HYDROCHLORIDE 250 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0591-3562_cd20b1d6-481b-4840-b36b-9933555d8e4b 0591-3562 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA078759 Watson Laboratories, Inc. GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0591-3563_cd20b1d6-481b-4840-b36b-9933555d8e4b 0591-3563 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA078759 Watson Laboratories, Inc. GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0591-3571_09af1973-baa6-4539-9c32-fc6f5d61ba67 0591-3571 HUMAN PRESCRIPTION DRUG Fentanyl buccal Fentanyl buccal TABLET BUCCAL; ORAL; TRANSMUCOSAL 20110107 ANDA ANDA079075 Watson Laboratories, Inc. FENTANYL CITRATE 100 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3572_09af1973-baa6-4539-9c32-fc6f5d61ba67 0591-3572 HUMAN PRESCRIPTION DRUG Fentanyl buccal Fentanyl buccal TABLET BUCCAL; ORAL; TRANSMUCOSAL 20110107 ANDA ANDA079075 Watson Laboratories, Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3573_09af1973-baa6-4539-9c32-fc6f5d61ba67 0591-3573 HUMAN PRESCRIPTION DRUG Fentanyl buccal Fentanyl buccal TABLET BUCCAL; ORAL; TRANSMUCOSAL 20110107 ANDA ANDA079075 Watson Laboratories, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3574_09af1973-baa6-4539-9c32-fc6f5d61ba67 0591-3574 HUMAN PRESCRIPTION DRUG Fentanyl buccal Fentanyl buccal TABLET BUCCAL; ORAL; TRANSMUCOSAL 20110107 ANDA ANDA079075 Watson Laboratories, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3575_09af1973-baa6-4539-9c32-fc6f5d61ba67 0591-3575 HUMAN PRESCRIPTION DRUG Fentanyl buccal Fentanyl buccal TABLET BUCCAL; ORAL; TRANSMUCOSAL 20110107 ANDA ANDA079075 Watson Laboratories, Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3576_6e1cb452-4764-4040-b6f0-b312ff686f39 0591-3576 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Watson Laboratories, Inc. MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3591_6ef2bfab-ab55-4888-816e-d61e6257e93d 0591-3591 HUMAN PRESCRIPTION DRUG DRONABINOL DRONABINOL CAPSULE ORAL 19940811 NDA NDA018651 Watson Laboratories, Inc. DRONABINOL 2.5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 0591-3592_6ef2bfab-ab55-4888-816e-d61e6257e93d 0591-3592 HUMAN PRESCRIPTION DRUG DRONABINOL DRONABINOL CAPSULE ORAL 20050607 NDA NDA018651 Watson Laboratories, Inc. DRONABINOL 5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 0591-3593_6ef2bfab-ab55-4888-816e-d61e6257e93d 0591-3593 HUMAN PRESCRIPTION DRUG DRONABINOL DRONABINOL CAPSULE ORAL 19940811 NDA NDA018651 Watson Laboratories, Inc. DRONABINOL 10 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 0591-3600_29e9f810-5b09-4c32-b208-dbedf25c0564 0591-3600 HUMAN PRESCRIPTION DRUG Fentanyl - NOVAPLUS Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Watson Laboratories, Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3601_29e9f810-5b09-4c32-b208-dbedf25c0564 0591-3601 HUMAN PRESCRIPTION DRUG Fentanyl - NOVAPLUS Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Watson Laboratories, Inc. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3602_29e9f810-5b09-4c32-b208-dbedf25c0564 0591-3602 HUMAN PRESCRIPTION DRUG Fentanyl - NOVAPLUS Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Watson Laboratories, Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3603_29e9f810-5b09-4c32-b208-dbedf25c0564 0591-3603 HUMAN PRESCRIPTION DRUG Fentanyl - NOVAPLUS Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Watson Laboratories, Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3611_7b7b3f18-9ec3-44af-887c-1b1085f72474 0591-3611 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA200431 Watson Laboratories, Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0591-3612_7b7b3f18-9ec3-44af-887c-1b1085f72474 0591-3612 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA200431 Watson Laboratories, Inc. ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0591-3613_7b7b3f18-9ec3-44af-887c-1b1085f72474 0591-3613 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA200431 Watson Laboratories, Inc. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0591-3614_7b7b3f18-9ec3-44af-887c-1b1085f72474 0591-3614 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA200431 Watson Laboratories, Inc. ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0591-3629_9e7a9597-7bac-4bd3-8d80-42f28a6be26b 0591-3629 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140521 ANDA ANDA202144 Watson Laboratories, Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3630_9e7a9597-7bac-4bd3-8d80-42f28a6be26b 0591-3630 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140521 ANDA ANDA202144 Watson Laboratories, Inc. HYDROMORPHONE HYDROCHLORIDE 16 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3635_5b254b17-ebfb-4d51-9da5-4244e96a4f58 0591-3635 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091093 Watson Laboratories, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0591-3636_e91fdc0d-a68b-46bd-8ca8-b9b7f248a994 0591-3636 HUMAN PRESCRIPTION DRUG Trospium Chloride Trospium Chloride CAPSULE, EXTENDED RELEASE ORAL 20121012 ANDA ANDA091289 Actavis Pharma, Inc. TROSPIUM CHLORIDE 60 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0591-3670_24aef463-7591-419f-9cee-eee35901c8b9 0591-3670 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20110613 ANDA ANDA091083 Watson Laboratories, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0591-3671_24aef463-7591-419f-9cee-eee35901c8b9 0591-3671 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20110613 ANDA ANDA091083 Watson Laboratories, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0591-3699_5b254b17-ebfb-4d51-9da5-4244e96a4f58 0591-3699 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091093 Watson Laboratories, Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0591-3700_7b7b3f18-9ec3-44af-887c-1b1085f72474 0591-3700 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA200431 Watson Laboratories, Inc. ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0591-3703_a9aa7b52-0cc6-4330-9b91-b723c95eec24 0591-3703 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20120828 ANDA ANDA200156 Watson Laboratories, Inc. ARMODAFINIL 100 mg/1 CIV 0591-3704_a9aa7b52-0cc6-4330-9b91-b723c95eec24 0591-3704 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20120828 ANDA ANDA200156 Watson Laboratories, Inc. ARMODAFINIL 200 mg/1 CIV 0591-3720_b6d15bca-7eda-4697-bd0a-21913f4a515e 0591-3720 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid TABLET, FILM COATED ORAL 20130103 ANDA ANDA202093 Actavis Pharma, Inc. TRANEXAMIC ACID 650 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 0591-3739_9e7a9597-7bac-4bd3-8d80-42f28a6be26b 0591-3739 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140521 ANDA ANDA202144 Watson Laboratories, Inc. HYDROMORPHONE HYDROCHLORIDE 12 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3740_9611cc53-15f8-4dd7-af24-7f6990d183cd 0591-3740 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074862 Watson Laboratories, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3741_9611cc53-15f8-4dd7-af24-7f6990d183cd 0591-3741 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074862 Watson Laboratories, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3742_9611cc53-15f8-4dd7-af24-7f6990d183cd 0591-3742 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074862 Watson Laboratories, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3743_9611cc53-15f8-4dd7-af24-7f6990d183cd 0591-3743 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074769 Watson Laboratories, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3744_9611cc53-15f8-4dd7-af24-7f6990d183cd 0591-3744 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074769 Watson Laboratories, Inc. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0591-3745_8039da21-4cd9-4179-a6f5-d71c67c1ef19 0591-3745 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20110222 ANDA ANDA091129 Watson Laboratories, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0591-3746_8039da21-4cd9-4179-a6f5-d71c67c1ef19 0591-3746 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20110222 ANDA ANDA091129 Watson Laboratories, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0591-3747_8039da21-4cd9-4179-a6f5-d71c67c1ef19 0591-3747 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20110222 ANDA ANDA091129 Watson Laboratories, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0591-3748_9353db75-51d5-444d-977d-de910fd6d72d 0591-3748 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20110112 ANDA ANDA200180 Watson Laboratories, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0591-3749_9353db75-51d5-444d-977d-de910fd6d72d 0591-3749 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20110112 ANDA ANDA200180 Watson Laboratories, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0591-3750_9353db75-51d5-444d-977d-de910fd6d72d 0591-3750 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20110112 ANDA ANDA200180 Watson Laboratories, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0591-3751_5e3b327d-9472-9bf3-0a30-dfc0c53c29f6 0591-3751 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA078551 Watson Pharma, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0591-3752_5e3b327d-9472-9bf3-0a30-dfc0c53c29f6 0591-3752 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA078551 Watson Pharma, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0591-3753_5e3b327d-9472-9bf3-0a30-dfc0c53c29f6 0591-3753 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA078551 Watson Pharma, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0591-3754_5e3b327d-9472-9bf3-0a30-dfc0c53c29f6 0591-3754 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA078551 Watson Pharma, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0591-3755_5e3b327d-9472-9bf3-0a30-dfc0c53c29f6 0591-3755 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA078551 Watson Pharma, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0591-3757_9b13f4a1-ebee-461f-b876-ef061dbdd35b 0591-3757 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride Amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20101013 ANDA ANDA077890 Watson Laboratories, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0591-3758_9b13f4a1-ebee-461f-b876-ef061dbdd35b 0591-3758 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride Amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20101013 ANDA ANDA077890 Watson Laboratories, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0591-3759_9b13f4a1-ebee-461f-b876-ef061dbdd35b 0591-3759 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride Amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20101013 ANDA ANDA077890 Watson Laboratories, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0591-3760_9b13f4a1-ebee-461f-b876-ef061dbdd35b 0591-3760 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride Amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20101013 ANDA ANDA077890 Watson Laboratories, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0591-3761_a2cbb94c-12d7-4b99-949e-245266f7f498 0591-3761 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA090364 Watson Laboratories, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0591-3762_a2cbb94c-12d7-4b99-949e-245266f7f498 0591-3762 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA090364 Watson Laboratories, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0591-3767_97f98666-3746-4722-9b82-c08f7607023d 0591-3767 HUMAN PRESCRIPTION DRUG Budesonide Inhalation Budesonide SUSPENSION RESPIRATORY (INHALATION) 20130402 ANDA ANDA078404 Watson Laboratories, Inc. BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0591-3768_97f98666-3746-4722-9b82-c08f7607023d 0591-3768 HUMAN PRESCRIPTION DRUG Budesonide Inhalation Budesonide SUSPENSION RESPIRATORY (INHALATION) 20130402 ANDA ANDA078404 Watson Laboratories, Inc. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0591-3770_e3888af3-e12d-4001-a507-82bc544bca07 0591-3770 HUMAN PRESCRIPTION DRUG Ibandronate Sodium ibandronate sodium TABLET ORAL 20120320 ANDA ANDA079003 Watson Laboratories, Inc. IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0591-3774_ea563d25-0c19-4285-bb0c-095c8e461aae 0591-3774 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Watson Laboratories, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0591-3775_ea563d25-0c19-4285-bb0c-095c8e461aae 0591-3775 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Watson Laboratories, Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0591-3776_ea563d25-0c19-4285-bb0c-095c8e461aae 0591-3776 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Watson Laboratories, Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0591-3777_ea563d25-0c19-4285-bb0c-095c8e461aae 0591-3777 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Watson Laboratories, Inc. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0591-3780_66a6e344-fbfb-482b-9dea-60a89eeaf119 0591-3780 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil citrate TABLET, FILM COATED ORAL 20121106 ANDA ANDA202503 Actavis Pharma, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 0591-3797_f15ea7ee-1b4e-47a1-b4dd-3c1b96bd3a68 0591-3797 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION INTRABRONCHIAL 20101104 ANDA ANDA077839 Actavis Pharma, Inc. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0591-3798_b82da04a-7b9f-4726-aece-cb2f263401df 0591-3798 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20110301 ANDA ANDA075693 Watson Laboratories, Inc. IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0591-3817_613c6b3c-5b3e-48e3-911d-ec586981c82c 0591-3817 HUMAN PRESCRIPTION DRUG ipratropium bromide and albuterol sulfate ipratropium bromide and albuterol sulfate SOLUTION RESPIRATORY (INHALATION) 20130513 ANDA ANDA202496 Watson Laboratories, Inc. ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 2.5; .5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0591-3964_c701ae72-5b90-371d-b6c4-f1b0b5200f96 0591-3964 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20100730 NDA NDA019781 Watson Laboratories, Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 0591-3965_c701ae72-5b90-371d-b6c4-f1b0b5200f96 0591-3965 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20100730 NDA NDA019781 Watson Laboratories, Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 0591-3971_bc260f36-c7ba-48bb-bc5d-d56525ccd9e9 0591-3971 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051028 ANDA ANDA077270 Watson Laboratories, Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0591-3972_bc260f36-c7ba-48bb-bc5d-d56525ccd9e9 0591-3972 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051028 ANDA ANDA077270 Watson Laboratories, Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0591-3973_bc260f36-c7ba-48bb-bc5d-d56525ccd9e9 0591-3973 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051028 ANDA ANDA077270 Watson Laboratories, Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0591-4012_4593c86d-cb87-444f-8919-2bd70e23783a 0591-4012 HUMAN PRESCRIPTION DRUG Valproic Valproic Acid CAPSULE, LIQUID FILLED ORAL 20090908 ANDA ANDA073229 Actavis Pharma, Inc. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0591-5052_c9a6bcf7-85ea-4847-ad36-30cdfa63b9cf 0591-5052 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA080356 Watson Laboratories, Inc. PREDNISONE 5 mg/1 0591-5215_155b5133-c92a-4836-ae26-2e91cf2ce9cf 0591-5215 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20141124 ANDA ANDA070044 Actavis Pharma, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0591-5238_102552df-6770-42a0-b488-87e57abb12c0 0591-5238 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 19730503 ANDA ANDA083308 Watson Laboratories, Inc. MEPROBAMATE 400 mg/1 CIV 0591-5239_102552df-6770-42a0-b488-87e57abb12c0 0591-5239 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 19730423 ANDA ANDA083304 Watson Laboratories, Inc. MEPROBAMATE 200 mg/1 CIV 0591-5307_2b1d850a-bdca-4c98-9381-320d7fc67ec4 0591-5307 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19730919 ANDA ANDA083426 Watson Laboratories, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0591-5319_2b1d850a-bdca-4c98-9381-320d7fc67ec4 0591-5319 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19730921 ANDA ANDA083711 Watson Laboratories, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0591-5321_5b3bfda3-e651-4b62-93e7-cdfcbc1e3ccf 0591-5321 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20100619 ANDA ANDA083551 Watson Laboratories, Inc. PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0591-5325_02373e3d-fe98-4f88-88d6-f20aa8e42672 0591-5325 HUMAN PRESCRIPTION DRUG Probenecid and Colchicine Probenecid and Colchicine TABLET ORAL 19821001 ANDA ANDA084279 Watson Laboratories, Inc. COLCHICINE; PROBENECID .5; 500 mg/1; mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 0591-5335_5e9de8a0-3564-447f-942b-849565d3a195 0591-5335 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 19871101 ANDA ANDA084363 Watson Laboratories, Inc. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 0591-5337_5e9de8a0-3564-447f-942b-849565d3a195 0591-5337 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 19871101 ANDA ANDA084364 Watson Laboratories, Inc. TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 0591-5347_3aa33bdd-d59e-4db9-b447-65dc2eca60bb 0591-5347 HUMAN PRESCRIPTION DRUG Probenecid Probenecid TABLET, FILM COATED ORAL 19830701 ANDA ANDA084442 Watson Laboratories, Inc. PROBENECID 500 mg/1 0591-5381_b86073f0-11d7-4f46-aad8-ee3dc518c76b 0591-5381 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19871101 ANDA ANDA084277 Watson Laboratories, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0591-5382_b86073f0-11d7-4f46-aad8-ee3dc518c76b 0591-5382 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19871101 ANDA ANDA084276 Watson Laboratories, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0591-5438_89d03d0f-7d8c-4f38-a310-9a9739a03397 0591-5438 HUMAN PRESCRIPTION DRUG Quinidine Sulfate Quinidine Sulfate TABLET ORAL 19761124 ANDA ANDA083288 Watson Laboratories, Inc. QUINIDINE SULFATE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] 0591-5440_299dfc7f-0ffc-4b6e-9589-184a3f656653 0591-5440 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19770214 ANDA ANDA062031 Watson Laboratories, Inc. DOXYCYCLINE HYCLATE 100 mg/1 0591-5442_c9a6bcf7-85ea-4847-ad36-30cdfa63b9cf 0591-5442 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA085162 Watson Laboratories, Inc. PREDNISONE 10 mg/1 0591-5443_c9a6bcf7-85ea-4847-ad36-30cdfa63b9cf 0591-5443 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA085161 Watson Laboratories, Inc. PREDNISONE 20 mg/1 0591-5454_89d03d0f-7d8c-4f38-a310-9a9739a03397 0591-5454 HUMAN PRESCRIPTION DRUG Quinidine Sulfate Quinidine Sulfate TABLET ORAL 19810609 ANDA ANDA085583 Watson Laboratories, Inc. QUINIDINE SULFATE 300 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] 0591-5513_455fefe4-d1ff-40b4-b0f4-6f66386b828e 0591-5513 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19871101 ANDA ANDA087499 Watson Laboratories, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 0591-5522_956abfb6-ee22-42b2-9021-ae6f38a296e4 0591-5522 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20111121 ANDA ANDA088348 Watson Laboratories, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0591-5523_956abfb6-ee22-42b2-9021-ae6f38a296e4 0591-5523 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20111121 ANDA ANDA088349 Watson Laboratories, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0591-5535_299dfc7f-0ffc-4b6e-9589-184a3f656653 0591-5535 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19821013 ANDA ANDA062031 Watson Laboratories, Inc. DOXYCYCLINE HYCLATE 50 mg/1 0591-5543_9139518b-2a60-4cfa-90e0-e14bb98ad74a 0591-5543 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018832 Watson Laboratories, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 0591-5544_9139518b-2a60-4cfa-90e0-e14bb98ad74a 0591-5544 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018877 Watson Laboratories, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 0591-5553_299dfc7f-0ffc-4b6e-9589-184a3f656653 0591-5553 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 19830202 ANDA ANDA062421 Watson Laboratories, Inc. DOXYCYCLINE HYCLATE 100 mg/1 0591-5554_42c57d8d-e046-43c3-aed0-40acc21ef45e 0591-5554 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070175 Watson Laboratories, Inc. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0591-5555_42c57d8d-e046-43c3-aed0-40acc21ef45e 0591-5555 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070176 Watson Laboratories, Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0591-5556_42c57d8d-e046-43c3-aed0-40acc21ef45e 0591-5556 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070177 Watson Laboratories, Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0591-5557_42c57d8d-e046-43c3-aed0-40acc21ef45e 0591-5557 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070178 Watson Laboratories, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0591-5560_b4c34921-cf4e-40f8-9631-87f7c0b5d875 0591-5560 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 19850531 ANDA ANDA070173 Watson Laboratories, Inc. DISOPYRAMIDE PHOSPHATE 100 mg/1 Antiarrhythmic [EPC] 0591-5561_b4c34921-cf4e-40f8-9631-87f7c0b5d875 0591-5561 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 19850531 ANDA ANDA070174 Watson Laboratories, Inc. DISOPYRAMIDE PHOSPHATE 150 mg/1 Antiarrhythmic [EPC] 0591-5571_5aeebce8-ff97-44e3-8b59-7775d04dbcd0 0591-5571 HUMAN PRESCRIPTION DRUG Trimethoprim Trimethoprim TABLET ORAL 20100404 ANDA ANDA070049 Watson Laboratories, Inc. TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0591-5619_32932dae-757d-4285-bf02-c3073ba6ed46 0591-5619 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071135 Watson Laboratories, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0591-5620_32932dae-757d-4285-bf02-c3073ba6ed46 0591-5620 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071136 Watson Laboratories, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0591-5621_32932dae-757d-4285-bf02-c3073ba6ed46 0591-5621 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071134 Watson Laboratories, Inc. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0591-5642_c9ff0fa9-45b7-40bc-b452-3faa29dda79c 0591-5642 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 20091026 ANDA ANDA071344 Watson Laboratories, Inc. MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 0591-5643_c9ff0fa9-45b7-40bc-b452-3faa29dda79c 0591-5643 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 20091026 ANDA ANDA071345 Watson Laboratories, Inc. MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 0591-5658_8bd541af-7c73-4795-bfb0-a05232f0c20e 0591-5658 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19890503 ANDA ANDA071611 Watson Laboratories, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0591-5660_b018a7bc-3fb4-4dbe-88e8-7017a1cf0ebc 0591-5660 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 19900403 ANDA ANDA071795 Watson Laboratories, Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0591-5661_b018a7bc-3fb4-4dbe-88e8-7017a1cf0ebc 0591-5661 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 19900403 ANDA ANDA071891 Watson Laboratories, Inc. SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0591-5694_828dd059-0f04-4c64-9ad0-cb2437d9c307 0591-5694 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063181 Actavis Pharma, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0591-5695_828dd059-0f04-4c64-9ad0-cb2437d9c307 0591-5695 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063065 Actavis Pharma, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0591-5708_0c4ee9d3-77b0-4656-8493-bcccc086e61a 0591-5708 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 19910731 ANDA ANDA063083 Actavis Pharma, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0591-5713_9918b12e-bd7a-4061-9414-cfca53689b6b 0591-5713 HUMAN PRESCRIPTION DRUG Amoxapine Amoxapine TABLET ORAL 19920828 ANDA ANDA072688 Actavis Pharma, Inc. AMOXAPINE 25 mg/1 Tricyclic Antidepressant [EPC] 0591-5714_9918b12e-bd7a-4061-9414-cfca53689b6b 0591-5714 HUMAN PRESCRIPTION DRUG Amoxapine Amoxapine TABLET ORAL 19920828 ANDA ANDA072689 Actavis Pharma, Inc. AMOXAPINE 50 mg/1 Tricyclic Antidepressant [EPC] 0591-5715_9918b12e-bd7a-4061-9414-cfca53689b6b 0591-5715 HUMAN PRESCRIPTION DRUG Amoxapine Amoxapine TABLET ORAL 19920828 ANDA ANDA072690 Actavis Pharma, Inc. AMOXAPINE 100 mg/1 Tricyclic Antidepressant [EPC] 0591-5716_9918b12e-bd7a-4061-9414-cfca53689b6b 0591-5716 HUMAN PRESCRIPTION DRUG Amoxapine Amoxapine TABLET ORAL 19920828 ANDA ANDA072691 Actavis Pharma, Inc. AMOXAPINE 150 mg/1 Tricyclic Antidepressant [EPC] 0591-5782_0c9cad7b-e8cf-44e0-aa5f-488e2b2ce9eb 0591-5782 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Watson Laboratories, Inc. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0591-5783_0c9cad7b-e8cf-44e0-aa5f-488e2b2ce9eb 0591-5783 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Watson Laboratories, Inc. ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0591-5786_2a021427-d29d-4d2e-b9a1-6ef32ffc1c55 0591-5786 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073553 Watson Laboratories, Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0591-5787_2a021427-d29d-4d2e-b9a1-6ef32ffc1c55 0591-5787 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073554 Watson Laboratories, Inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0591-5788_2a021427-d29d-4d2e-b9a1-6ef32ffc1c55 0591-5788 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073555 Watson Laboratories, Inc. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0591-5789_2a021427-d29d-4d2e-b9a1-6ef32ffc1c55 0591-5789 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073556 Watson Laboratories, Inc. NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 0591-5882_65d55238-1c50-4699-a233-4717805244c6 0591-5882 HUMAN PRESCRIPTION DRUG methylphenidate hcl methylphenidate hcl TABLET ORAL 19970829 ANDA ANDA040220 Watson Laboratories, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0591-5883_65d55238-1c50-4699-a233-4717805244c6 0591-5883 HUMAN PRESCRIPTION DRUG methylphenidate hcl methylphenidate hcl TABLET ORAL 19970829 ANDA ANDA040220 Watson Laboratories, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0591-5884_65d55238-1c50-4699-a233-4717805244c6 0591-5884 HUMAN PRESCRIPTION DRUG methylphenidate hcl methylphenidate hcl TABLET ORAL 19970829 ANDA ANDA040220 Watson Laboratories, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0597-0001_3360e445-ab4a-4a30-89b3-688d58977214 0597-0001 HUMAN PRESCRIPTION DRUG Aggrenox aspirin and dipyridamole CAPSULE ORAL 19991219 NDA NDA020884 Boehringer Ingelheim Pharmaceuticals, Inc. ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0597-0002_b39aa455-4ddb-47e9-890c-30f091580934 0597-0002 HUMAN PRESCRIPTION DRUG Aptivus tipranavir SOLUTION ORAL 20080901 NDA NDA022292 Boehringer Ingelheim Pharmaceuticals, Inc. TIPRANAVIR 100 mg/mL HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 0597-0003_b39aa455-4ddb-47e9-890c-30f091580934 0597-0003 HUMAN PRESCRIPTION DRUG Aptivus tipranavir CAPSULE, LIQUID FILLED ORAL 20050701 NDA NDA021814 Boehringer Ingelheim Pharmaceuticals, Inc. TIPRANAVIR 250 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 0597-0006_6796cb88-8871-40d1-ac5f-63fa3246aaff 0597-0006 HUMAN PRESCRIPTION DRUG Catapres clonidine hydrochloride TABLET ORAL 19990501 NDA NDA017407 Boehringer Ingelheim Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0597-0007_6796cb88-8871-40d1-ac5f-63fa3246aaff 0597-0007 HUMAN PRESCRIPTION DRUG Catapres clonidine hydrochloride TABLET ORAL 19990501 NDA NDA017407 Boehringer Ingelheim Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0597-0011_6796cb88-8871-40d1-ac5f-63fa3246aaff 0597-0011 HUMAN PRESCRIPTION DRUG Catapres clonidine hydrochloride TABLET ORAL 19990501 NDA NDA017407 Boehringer Ingelheim Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0597-0012_8527ae95-fdfd-4b62-9f56-598c2656aeb6 0597-0012 HUMAN OTC DRUG Dulcolax bisacodyl TABLET, COATED ORAL 20011001 OTC MONOGRAPH NOT FINAL part334 Boehringer Ingelheim Pharmaceuticals, Inc. BISACODYL 5 mg/1 0597-0013_3ef1443e-aa10-4f24-b700-6a1c1b239324 0597-0013 HUMAN PRESCRIPTION DRUG Combivent ipratropium bromide and albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 19970601 NDA NDA020291 Boehringer Ingelheim Pharmaceuticals, Inc. ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 103; 18 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0597-0016_26f70cef-c173-4aa7-9d9a-b105cb8fca0a 0597-0016 HUMAN OTC DRUG Dulcolax Docusate sodium GEL ORAL 20021001 OTC MONOGRAPH NOT FINAL part334 Boehringer Ingelheim Pharmaceuticals, Inc. DOCUSATE SODIUM 100 mg/1 0597-0017_64df3878-9783-4fe3-86c0-ae13b29af8ab 0597-0017 HUMAN PRESCRIPTION DRUG Persantine dipyridamole TABLET, COATED ORAL 19990601 NDA NDA012836 Boehringer Ingelheim Pharmaceuticals, Inc. DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0597-0018_64df3878-9783-4fe3-86c0-ae13b29af8ab 0597-0018 HUMAN PRESCRIPTION DRUG Persantine dipyridamole TABLET, COATED ORAL 19990601 NDA NDA012836 Boehringer Ingelheim Pharmaceuticals, Inc. DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0597-0019_64df3878-9783-4fe3-86c0-ae13b29af8ab 0597-0019 HUMAN PRESCRIPTION DRUG Persantine dipyridamole TABLET, COATED ORAL 19990601 NDA NDA012836 Boehringer Ingelheim Pharmaceuticals, Inc. DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0597-0024_3c8d25b9-fd93-ba13-42ac-0289a1d7425c 0597-0024 HUMAN PRESCRIPTION DRUG Combivent Respimat ipratropium bromide and albuterol SPRAY, METERED RESPIRATORY (INHALATION) 20120701 NDA NDA021747 Boehringer Ingelheim Pharmaceuticals Inc. ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 120; 20 ug/1; ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0597-0029_9f17db91-a8af-1e89-b992-d6a31be324a6 0597-0029 HUMAN PRESCRIPTION DRUG Mobic meloxicam TABLET ORAL 20000601 NDA NDA020938 Boehringer Ingelheim Pharmaceuticals, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0597-0030_9f17db91-a8af-1e89-b992-d6a31be324a6 0597-0030 HUMAN PRESCRIPTION DRUG Mobic meloxicam TABLET ORAL 20001001 NDA NDA020938 Boehringer Ingelheim Pharmaceuticals, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0597-0031_5b22f8cb-2f48-4f70-b996-f9ab65e758c4 0597-0031 HUMAN PRESCRIPTION DRUG Catapres clonidine PATCH, EXTENDED RELEASE TRANSDERMAL 19851001 NDA NDA018891 Boehringer Ingelheim Pharmaceuticals Inc. CLONIDINE .1 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0597-0032_5b22f8cb-2f48-4f70-b996-f9ab65e758c4 0597-0032 HUMAN PRESCRIPTION DRUG Catapres clonidine PATCH, EXTENDED RELEASE TRANSDERMAL 19851001 NDA NDA018891 Boehringer Ingelheim Pharmaceuticals Inc. CLONIDINE .2 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0597-0033_5b22f8cb-2f48-4f70-b996-f9ab65e758c4 0597-0033 HUMAN PRESCRIPTION DRUG Catapres clonidine PATCH, EXTENDED RELEASE TRANSDERMAL 19851001 NDA NDA018891 Boehringer Ingelheim Pharmaceuticals Inc. CLONIDINE .3 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0597-0034_9f17db91-a8af-1e89-b992-d6a31be324a6 0597-0034 HUMAN PRESCRIPTION DRUG Mobic meloxicam SUSPENSION ORAL 20051101 NDA NDA021530 Boehringer Ingelheim Pharmaceuticals, Inc. MELOXICAM 7.5 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0597-0039_a174342b-5789-4bf2-8670-c7dc1c95b8f0 0597-0039 HUMAN PRESCRIPTION DRUG Micardis telmisartan TABLET ORAL 20001201 NDA NDA020850 Boehringer Ingelheim Pharmaceuticals, Inc. TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0597-0040_a174342b-5789-4bf2-8670-c7dc1c95b8f0 0597-0040 HUMAN PRESCRIPTION DRUG Micardis telmisartan TABLET ORAL 20001201 NDA NDA020850 Boehringer Ingelheim Pharmaceuticals, Inc. TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0597-0041_a174342b-5789-4bf2-8670-c7dc1c95b8f0 0597-0041 HUMAN PRESCRIPTION DRUG Micardis telmisartan TABLET ORAL 20001201 NDA NDA020850 Boehringer Ingelheim Pharmaceuticals, Inc. TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0597-0042_75d85c7f-0d6c-4074-a4f2-ba5eda88f424 0597-0042 HUMAN PRESCRIPTION DRUG Micardis HCT telmisartan and hydrochlorothiazide TABLET ORAL 20001201 NDA NDA021162 Boehringer Ingelheim Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 25; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0597-0043_75d85c7f-0d6c-4074-a4f2-ba5eda88f424 0597-0043 HUMAN PRESCRIPTION DRUG Micardis HCT telmisartan and hydrochlorothiazide TABLET ORAL 20001201 NDA NDA021162 Boehringer Ingelheim Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0597-0044_75d85c7f-0d6c-4074-a4f2-ba5eda88f424 0597-0044 HUMAN PRESCRIPTION DRUG Micardis HCT telmisartan and hydrochlorothiazide TABLET ORAL 20001201 NDA NDA021162 Boehringer Ingelheim Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0597-0046_049dcd85-2836-454f-62dc-2e0632bead98 0597-0046 HUMAN PRESCRIPTION DRUG Viramune nevirapine TABLET ORAL 20010801 NDA NDA020636 Boehringer Ingelheim Pharmaceuticals Inc. NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 0597-0047_049dcd85-2836-454f-62dc-2e0632bead98 0597-0047 HUMAN PRESCRIPTION DRUG Viramune nevirapine SUSPENSION ORAL 20011001 NDA NDA020933 Boehringer Ingelheim Pharmaceuticals Inc. NEVIRAPINE 50 mg/5mL Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 0597-0052_53b68e2d-3c20-4178-af00-617a4498fdb3 0597-0052 HUMAN OTC DRUG Dulcolax Bisacodyl SUPPOSITORY RECTAL 20020401 OTC MONOGRAPH NOT FINAL part334 Boehringer Ingelheim Pharmaceuticals, Inc. BISACODYL 10 mg/1 0597-0058_bcd0f2f6-abf6-a29e-af9c-04e1047e01ae 0597-0058 HUMAN PRESCRIPTION DRUG Flomax tamsulosin hydrochloride CAPSULE ORAL 19970912 NDA NDA020579 Boehringer Ingelheim Pharmaceuticals, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0597-0075_60696a35-8119-19f6-f9b3-0f77b993ac5f 0597-0075 HUMAN PRESCRIPTION DRUG Spiriva TIOTROPIUM BROMIDE CAPSULE ORAL; RESPIRATORY (INHALATION) 20051011 NDA NDA021395 Boehringer Ingelheim Pharmaceuticals Inc. TIOTROPIUM BROMIDE MONOHYDRATE 18 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0597-0081_fff03366-39d3-4c3f-b8f5-63a379f097a3 0597-0081 HUMAN PRESCRIPTION DRUG Atrovent IPRATROPIUM BROMIDE SPRAY, METERED NASAL 19960101 NDA NDA020393 Boehringer Ingelheim Pharmaceuticals, Inc. IPRATROPIUM BROMIDE 21 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0597-0086_79df3d6e-8985-4321-a3c5-29777afecf07 0597-0086 HUMAN PRESCRIPTION DRUG Atrovent IPRATROPIUM BROMIDE SPRAY, METERED NASAL 19960101 NDA NDA020394 Boehringer Ingelheim Pharmaceuticals, Inc. IPRATROPIUM BROMIDE 42 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0597-0087_e22f2968-efa5-3e83-a678-e79962ac343a 0597-0087 HUMAN PRESCRIPTION DRUG Atrovent HFA ipratropium bromide AEROSOL, METERED RESPIRATORY (INHALATION) 20050501 NDA NDA021527 Boehringer Ingelheim Pharmaceuticals Inc. IPRATROPIUM BROMIDE 17 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0597-0100_7b656b14-fcaa-2741-f6f0-e0be48971c02 0597-0100 HUMAN PRESCRIPTION DRUG Spiriva Respimat tiotropium bromide inhalation spray SPRAY, METERED RESPIRATORY (INHALATION) 20140930 NDA NDA021936 Boehringer Ingelheim Pharmaceuticals, Inc. TIOTROPIUM BROMIDE 3.124 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0597-0101_c0610ed1-a629-4bb9-00ea-ffa2211ac8d3 0597-0101 HUMAN PRESCRIPTION DRUG Mirapex pramipexole dihydrochloride TABLET ORAL 20071001 NDA NDA020667 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0597-0109_dd942447-f7f6-b4c0-a05a-d1fb7028be76 0597-0109 HUMAN PRESCRIPTION DRUG Mirapex ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20100222 NDA NDA022421 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .375 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0597-0113_dd942447-f7f6-b4c0-a05a-d1fb7028be76 0597-0113 HUMAN PRESCRIPTION DRUG Mirapex ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20100222 NDA NDA022421 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0597-0115_dd942447-f7f6-b4c0-a05a-d1fb7028be76 0597-0115 HUMAN PRESCRIPTION DRUG Mirapex ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20100222 NDA NDA022421 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0597-0116_dd942447-f7f6-b4c0-a05a-d1fb7028be76 0597-0116 HUMAN PRESCRIPTION DRUG Mirapex ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20100222 NDA NDA022421 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 4.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0597-0120_775f336a-b837-4532-bb8c-ff67e0b7d44b 0597-0120 HUMAN OTC DRUG Zantac Maximum Strength 150 Cool Mint ranitidine TABLET, COATED ORAL 20061221 NDA NDA021698 Boehringer Ingelheim Pharmaceuticals Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 0597-0121_a30ce650-2dd0-43be-a571-393dae2b15d5 0597-0121 HUMAN OTC DRUG Maximum Strength Zantac ranitidine TABLET, COATED ORAL 20061221 NDA NDA021698 Boehringer Ingelheim Pharmaceuticals Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 0597-0122_95078fd3-0bb4-ffe3-2e33-97471de88e06 0597-0122 HUMAN OTC DRUG Zantac 75 ranitidine TABLET, COATED ORAL 20061221 NDA NDA020520 Boehringer Ingelheim Pharmaceuticals Inc. RANITIDINE HYDROCHLORIDE 75 mg/1 0597-0123_49b74b5c-6d02-3aca-1d53-c9d36d43d502 0597-0123 HUMAN PRESCRIPTION DRUG Viramune nevirapine TABLET, EXTENDED RELEASE ORAL 20110411 NDA NDA201152 Boehringer Ingelheim Pharmaceuticals, Inc. NEVIRAPINE 400 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 0597-0124_51a803c9-a4c0-4778-9df7-54dab72ad945 0597-0124 HUMAN PRESCRIPTION DRUG Twynsta telmisartan/amlodipine TABLET, MULTILAYER ORAL 20091102 NDA NDA022401 Boehringer Ingelheim Pharmaceuticals, Inc. AMLODIPINE BESYLATE; TELMISARTAN 5; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0597-0125_51a803c9-a4c0-4778-9df7-54dab72ad945 0597-0125 HUMAN PRESCRIPTION DRUG Twynsta telmisartan/amlodipine TABLET, MULTILAYER ORAL 20091102 NDA NDA022401 Boehringer Ingelheim Pharmaceuticals, Inc. AMLODIPINE BESYLATE; TELMISARTAN 10; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0597-0126_51a803c9-a4c0-4778-9df7-54dab72ad945 0597-0126 HUMAN PRESCRIPTION DRUG Twynsta telmisartan/amlodipine TABLET, MULTILAYER ORAL 20091102 NDA NDA022401 Boehringer Ingelheim Pharmaceuticals, Inc. AMLODIPINE BESYLATE; TELMISARTAN 5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0597-0127_51a803c9-a4c0-4778-9df7-54dab72ad945 0597-0127 HUMAN PRESCRIPTION DRUG Twynsta telmisartan/amlodipine TABLET, MULTILAYER ORAL 20091102 NDA NDA022401 Boehringer Ingelheim Pharmaceuticals, Inc. AMLODIPINE BESYLATE; TELMISARTAN 10; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0597-0129_49b74b5c-6d02-3aca-1d53-c9d36d43d502 0597-0129 HUMAN PRESCRIPTION DRUG Viramune nevirapine TABLET, EXTENDED RELEASE ORAL 20130301 NDA NDA201152 Boehringer Ingelheim Pharmaceuticals, Inc. NEVIRAPINE 100 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 0597-0135_ba514c17-d5e3-8e18-b7a5-78d43ea470d3 0597-0135 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate mesylate CAPSULE ORAL 20101026 NDA NDA022512 Boehringer Ingelheim Pharmaceuticals Inc. DABIGATRAN ETEXILATE MESYLATE 150 mg/1 0597-0137_dccdf7cf-49aa-c7d9-8d26-937ba8504a28 0597-0137 HUMAN PRESCRIPTION DRUG Gilotrif afatinib TABLET, FILM COATED ORAL 20130712 NDA NDA201292 Boehringer Ingelheim Pharmaceuticals, Inc. AFATINIB 30 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0597-0138_dccdf7cf-49aa-c7d9-8d26-937ba8504a28 0597-0138 HUMAN PRESCRIPTION DRUG Gilotrif afatinib TABLET, FILM COATED ORAL 20130712 NDA NDA201292 Boehringer Ingelheim Pharmaceuticals, Inc. AFATINIB 40 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0597-0140_17f00f7e-1110-5620-534d-3a204c8897b9 0597-0140 HUMAN PRESCRIPTION DRUG Tradjenta linagliptin TABLET, FILM COATED ORAL 20110509 NDA NDA201280 Boehringer Ingelheim Pharmaceuticals, Inc. LINAGLIPTIN 5 mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC] 0597-0141_dccdf7cf-49aa-c7d9-8d26-937ba8504a28 0597-0141 HUMAN PRESCRIPTION DRUG Gilotrif afatinib TABLET, FILM COATED ORAL 20130712 NDA NDA201292 Boehringer Ingelheim Pharmaceuticals, Inc. AFATINIB 20 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 0597-0143_fb8b3d0f-2437-49ae-948e-9245cc97cf8b 0597-0143 HUMAN PRESCRIPTION DRUG Ofev nintedanib CAPSULE ORAL 20141028 NDA NDA205832 Boehringer Ingelheim Pharmaceuticals, Inc. NINTEDANIB 100 mg/1 0597-0145_fb8b3d0f-2437-49ae-948e-9245cc97cf8b 0597-0145 HUMAN PRESCRIPTION DRUG Ofev nintedanib CAPSULE ORAL 20141028 NDA NDA205832 Boehringer Ingelheim Pharmaceuticals, Inc. NINTEDANIB 150 mg/1 0597-0146_650e4356-7f85-4d90-28d9-395a2e04cdda 0597-0146 HUMAN PRESCRIPTION DRUG Jentadueto linagliptin TABLET, FILM COATED ORAL 20120213 NDA NDA201281 Boehringer Ingelheim Pharmaceuticals, Inc. LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0597-0147_650e4356-7f85-4d90-28d9-395a2e04cdda 0597-0147 HUMAN PRESCRIPTION DRUG Jentadueto linagliptin TABLET, FILM COATED ORAL 20120213 NDA NDA201281 Boehringer Ingelheim Pharmaceuticals, Inc. LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5; 850 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0597-0148_650e4356-7f85-4d90-28d9-395a2e04cdda 0597-0148 HUMAN PRESCRIPTION DRUG Jentadueto linagliptin TABLET, FILM COATED ORAL 20120213 NDA NDA201281 Boehringer Ingelheim Pharmaceuticals, Inc. LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5; 1000 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0597-0149_ba514c17-d5e3-8e18-b7a5-78d43ea470d3 0597-0149 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate mesylate CAPSULE ORAL 20110808 NDA NDA022512 Boehringer Ingelheim Pharmaceuticals Inc. DABIGATRAN ETEXILATE MESYLATE 75 mg/1 0597-0151_0332254d-d503-1d0a-8846-dfbea8546ae7 0597-0151 HUMAN OTC DRUG DulcoEase Pink docusate sodium CAPSULE, LIQUID FILLED ORAL 20130201 OTC MONOGRAPH NOT FINAL part334 Boehringer Ingelheim Pharmaceuticals, Inc. DOCUSATE SODIUM 100 mg/1 0597-0152_faf3dd6a-9cd0-39c2-0d2e-232cb3f67565 0597-0152 HUMAN PRESCRIPTION DRUG Jardiance Empagliflozin TABLET, FILM COATED ORAL 20140801 NDA NDA204629 Boehringer Ingelheim Pharmaceuticals, Inc. EMPAGLIFLOZIN 10 mg/1 0597-0153_faf3dd6a-9cd0-39c2-0d2e-232cb3f67565 0597-0153 HUMAN PRESCRIPTION DRUG Jardiance Empagliflozin TABLET, FILM COATED ORAL 20140801 NDA NDA204629 Boehringer Ingelheim Pharmaceuticals, Inc. EMPAGLIFLOZIN 25 mg/1 0597-0158_c6cc4c7b-0c71-4c5a-37b9-731decaf2eb4 0597-0158 HUMAN OTC DRUG Vaprino A-D LOPERAMIDE HYDROCHLORIDE TABLET ORAL 20130902 ANDA ANDA076497 Boehringer Ingelheim Pharmaceuticals, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 0597-0165_d1958afe-a1fc-7ea7-6eae-6a5f2413e44f 0597-0165 HUMAN OTC DRUG DulcoGas simethicone TABLET, CHEWABLE ORAL 20140228 OTC MONOGRAPH FINAL part332 Boehringer Ingelheim Pharmaceuticals, Inc. DIMETHICONE 125 mg/1 0597-0166_bcd0f2f6-abf6-a29e-af9c-04e1047e01ae 0597-0166 HUMAN PRESCRIPTION DRUG Flomax tamsulosin hydrochloride CAPSULE ORAL 19970912 NDA NDA020579 Boehringer Ingelheim Pharmaceuticals, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0597-0169_265db5aa-7f7b-b91e-92a3-0aa97b251be5 0597-0169 HUMAN OTC DRUG Dulcolax Pink bisacodyl TABLET, COATED ORAL 20120623 OTC MONOGRAPH NOT FINAL part334 Boehringer Ingelheim Pharmaceuticals Inc. BISACODYL 5 mg/1 0597-0170_d1958afe-a1fc-7ea7-6eae-6a5f2413e44f 0597-0170 HUMAN OTC DRUG DulcoGas simethicone TABLET, CHEWABLE ORAL 20140228 OTC MONOGRAPH FINAL part332 Boehringer Ingelheim Pharmaceuticals, Inc. DIMETHICONE 125 mg/1 0597-0183_c0610ed1-a629-4bb9-00ea-ffa2211ac8d3 0597-0183 HUMAN PRESCRIPTION DRUG Mirapex pramipexole dihydrochloride TABLET ORAL 20040101 NDA NDA020667 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0597-0184_c0610ed1-a629-4bb9-00ea-ffa2211ac8d3 0597-0184 HUMAN PRESCRIPTION DRUG Mirapex pramipexole dihydrochloride TABLET ORAL 20040101 NDA NDA020667 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0597-0185_c0610ed1-a629-4bb9-00ea-ffa2211ac8d3 0597-0185 HUMAN PRESCRIPTION DRUG Mirapex pramipexole dihydrochloride TABLET ORAL 20040101 NDA NDA020667 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0597-0186_d1958afe-a1fc-7ea7-6eae-6a5f2413e44f 0597-0186 HUMAN OTC DRUG DulcoGas simethicone TABLET, CHEWABLE ORAL 20140410 OTC MONOGRAPH FINAL part332 Boehringer Ingelheim Pharmaceuticals, Inc. DIMETHICONE 125 mg/1 0597-0190_c0610ed1-a629-4bb9-00ea-ffa2211ac8d3 0597-0190 HUMAN PRESCRIPTION DRUG Mirapex pramipexole dihydrochloride TABLET ORAL 20040101 NDA NDA020667 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0597-0191_c0610ed1-a629-4bb9-00ea-ffa2211ac8d3 0597-0191 HUMAN PRESCRIPTION DRUG Mirapex pramipexole dihydrochloride TABLET ORAL 20040101 NDA NDA020667 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0597-0192_191ba44d-9ecf-2f17-af7a-866c9f3ea240 0597-0192 HUMAN PRESCRIPTION DRUG Striverdi Respimat olodaterol respimat inhalation spray SPRAY, METERED RESPIRATORY (INHALATION) 20140801 NDA NDA203108 Boehringer Ingelheim Pharmaceuticals, Inc. OLODATEROL HYDROCHLORIDE 2.5 ug/1 0597-0285_dd942447-f7f6-b4c0-a05a-d1fb7028be76 0597-0285 HUMAN PRESCRIPTION DRUG Mirapex ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20100222 NDA NDA022421 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0597-0286_dd942447-f7f6-b4c0-a05a-d1fb7028be76 0597-0286 HUMAN PRESCRIPTION DRUG Mirapex ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20110618 NDA NDA022421 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 2.25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0597-0287_dd942447-f7f6-b4c0-a05a-d1fb7028be76 0597-0287 HUMAN PRESCRIPTION DRUG Mirapex ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20110618 NDA NDA022421 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 3.75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0603-0024_4552c7db-7a5e-4d25-b09b-a13c26cef7f8 0603-0024 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20091103 OTC MONOGRAPH FINAL part343 Qualitest Pharmaceutical, Inc. ASPIRIN 81 mg/1 0603-0026_4e54a4e7-580a-4047-ac97-c216a2503c48 0603-0026 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20091103 OTC MONOGRAPH FINAL part343 Qualitest Pharmaceutical, Inc. ASPIRIN 81 mg/1 0603-0149_1edc7d09-6965-4809-94bf-9a6412e4836b 0603-0149 HUMAN OTC DRUG DocQLax senna and docusate sodium TABLET, FILM COATED ORAL 20070726 OTC MONOGRAPH NOT FINAL part334 Qualitest Pharmaceuticals DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 0603-0150_97fd49a9-3242-4dc7-b676-bf4b9f547dad 0603-0150 HUMAN OTC DRUG DocQLace docusate sodium CAPSULE ORAL 20110801 OTC MONOGRAPH NOT FINAL part334 Qualitest Pharmaceuticals DOCUSATE SODIUM 100 mg/1 0603-0168_1edfbcc1-db1b-47b3-9d05-20027155097b 0603-0168 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20091103 OTC MONOGRAPH NOT FINAL part343 Qualitest Pharmaceutical, Inc. ASPIRIN 325 mg/1 0603-0169_9230731c-88c6-4fb4-9546-b67d67ccf78f 0603-0169 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength TABLET ORAL 20110204 OTC MONOGRAPH FINAL part343 Qualitest Pharmaceuticals ASPIRIN 325 mg/1 0603-0179_bc435fed-245d-4fe4-9ec7-db862f622a19 0603-0179 HUMAN OTC DRUG FERROUS SULFATE IRON SUPPLEMENT TABLET ORAL 20010219 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals FERROUS SULFATE 325 mg/1 0603-0181_253f68c2-0edb-4798-95b6-70a6e0771cc8 0603-0181 HUMAN OTC DRUG FiberTab calcium polycarbophil TABLET ORAL 20050310 OTC MONOGRAPH NOT FINAL part334 Qualitest Pharmaceuticals CALCIUM POLYCARBOPHIL 625 mg/1 0603-0209_1cc7df94-48ae-4e8f-9141-a78a055c49c8 0603-0209 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20031203 OTC MONOGRAPH FINAL part331 Qualitest Pharmaceutical, Inc. MAGNESIUM OXIDE 400 mg/1 0603-0210_03c6cf11-6d9a-4571-852c-16dda04b3bf8 0603-0210 HUMAN OTC DRUG MYTAB For GAS Simethicone TABLET, CHEWABLE ORAL 19990312 OTC MONOGRAPH FINAL part332 Qualitest Pharmaceuticals DIMETHICONE 80 mg/1 0603-0211_1ba7aeb2-42fc-4a99-a7cc-c2b3ac4efd6d 0603-0211 HUMAN OTC DRUG MAXIMUM STRENGTH MYTAB For GAS Simethicone TABLET, CHEWABLE ORAL 19990312 OTC MONOGRAPH FINAL part332 Qualitest Pharmaceuticals DIMETHICONE 125 mg/1 0603-0213_2d97b2b3-e1ad-498f-8f7c-69b2d7cc073d 0603-0213 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20031006 OTC MONOGRAPH FINAL part331 Qualitest Pharmaceuticals MAGNESIUM OXIDE 253 mg/1 0603-0235_69d8744b-aab2-439c-977a-29e5f435b55a 0603-0235 HUMAN OTC DRUG Pink Bismuth bismuth subsalicylate TABLET, CHEWABLE ORAL 20030428 OTC MONOGRAPH FINAL part335 Qualitest Pharmaceuticals BISMUTH SUBSALICYLATE 262 mg/1 0603-0241_aa6b0ae4-1d34-4f2e-a2d6-2b299128aaf5 0603-0241 HUMAN OTC DRUG Q-DRYL Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0603-0263_ad6c081d-c917-4b1f-8e77-ed932334cd6f 0603-0263 HUMAN OTC DRUG Regular Strength QPAP Acetaminophen TABLET ORAL 20110602 OTC MONOGRAPH NOT FINAL part343 Qualitest Pharmaceuticals ACETAMINOPHEN 325 mg/1 0603-0265_7228c0e6-be83-4eb2-852a-cd5deff5e7a4 0603-0265 HUMAN OTC DRUG Extra Strength QPap Acetaminophen TABLET, COATED ORAL 19960201 OTC MONOGRAPH NOT FINAL part343 Qualitest Pharmaceuticals ACETAMINOPHEN 500 mg/1 0603-0268_6e3e777e-2432-40d1-b2bf-70980296dafd 0603-0268 HUMAN OTC DRUG Extra Strength QPAP Acetaminophen TABLET ORAL 20110602 OTC MONOGRAPH NOT FINAL part343 Qualitest Pharmaceuticals ACETAMINOPHEN 500 mg/1 0603-0282_530a04e9-02fa-4f0d-bf1f-0a986bade196 0603-0282 HUMAN OTC DRUG Senna-Lax Sennosides TABLET ORAL 19960127 OTC MONOGRAPH NOT FINAL part334 Qualitest Pharmaceutical, Inc. SENNOSIDES A AND B 8.6 mg/1 0603-0283_87e7fc2f-76c5-4adb-acdf-f249708f6301 0603-0283 HUMAN OTC DRUG SennaLax-S senna and docusate sodium TABLET, FILM COATED ORAL 20070726 OTC MONOGRAPH NOT FINAL part334 Qualitest Pharmaceuticals DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 0603-0410_2f5dc544-30bf-4d8f-a950-4389099f80d9 0603-0410 HUMAN OTC DRUG Vitamins A and D lanolin and petrolatum OINTMENT TOPICAL 19960701 OTC MONOGRAPH FINAL part347 Qualitest Pharmaceuticals LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g 0603-0441_13e05cf7-7178-4ad9-aa29-75c30ef884e2 0603-0441 HUMAN OTC DRUG Bacitracin zinc bacitracin zinc OINTMENT TOPICAL 20010901 OTC MONOGRAPH FINAL part333B Qualitest Pharmaceuticals BACITRACIN ZINC 500 [USP'U]/g 0603-0520_1700f778-7f9d-4cd5-a24c-dd97b9e971cf 0603-0520 HUMAN OTC DRUG Hemorrhoidal mineral oil and phenylephrine hcl and shark liver oil and white petrolatum OINTMENT TOPICAL 19970801 OTC MONOGRAPH FINAL part346 Qualitest Pharmaceuticals MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 140; 719; 2.5; 30 mg/g; mg/g; mg/g; mg/g 0603-0524_443dec34-c9b6-40f8-8389-98be1fef6e90 0603-0524 HUMAN OTC DRUG HEMORRHOIDAL RECTAL PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY RECTAL 20070101 OTC MONOGRAPH FINAL part346 Generics Bidco I, LLC dba Qualitest Pharmaceuticals COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 855; 2.5; 30 mg/g; mg/g; mg/g 0603-0535_2524c77c-7ddd-438d-8f5a-70458c6e95f8 0603-0535 HUMAN OTC DRUG Hydrocortisone hydrocortisone CREAM TOPICAL 20011001 OTC MONOGRAPH NOT FINAL part348 Qualitest Pharmaceuticals HYDROCORTISONE 10 mg/g 0603-0599_e12879d9-3ce0-4da5-84c2-f2ca31650779 0603-0599 HUMAN OTC DRUG Povidone-Iodine povidone-iodine OINTMENT TOPICAL 19970801 OTC MONOGRAPH NOT FINAL part333A Qualitest Pharmaceuticals POVIDONE-IODINE 1 g/100g 0603-0644_8fd7f6c8-079e-4040-a10e-fd8d92b74b28 0603-0644 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc and neomycin sulfate and polymyxin b sulfate OINTMENT TOPICAL 19970801 OTC MONOGRAPH FINAL part333B Qualitest Pharmaceuticals BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 0603-0648_6359d4bf-9438-4cc5-8d82-123fc13ccac8 0603-0648 HUMAN OTC DRUG Trixaicin Capsicum oleoresin CREAM TOPICAL 20010901 OTC MONOGRAPH FINAL part348 Qualitest Pharmaceuticals CAPSICUM OLEORESIN .25 mg/g 0603-0649_df87234c-35ff-47f3-8fad-4b0b3a0c8f6a 0603-0649 HUMAN OTC DRUG Trixaicin HP capsicum oleoresin CREAM TOPICAL 19951201 OTC MONOGRAPH NOT FINAL part348 Qualitest Pharmaceuticals CAPSICUM OLEORESIN .75 mg/g 0603-0728_f3f4caed-b479-4a0d-9c24-89b06726aa65 0603-0728 HUMAN OTC DRUG Codituss DM dextromethorphan hydrobromide and phenylephrine hydrochloride and pyrilamine maleate SYRUP ORAL 19971001 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE 10; 5; 8.33 mg/5mL; mg/5mL; mg/5mL 0603-0746_73f84500-8889-4571-8681-dec68925a5cc 0603-0746 HUMAN OTC DRUG Doc Q Lace Docusate sodium LIQUID ORAL 19901005 OTC MONOGRAPH NOT FINAL part334 Qualitest Pharmaceuticals DOCUSATE SODIUM 10 mg/mL 0603-0747_95206544-6a53-4ac2-b2e4-b33fb7782752 0603-0747 HUMAN OTC DRUG DocQLace Docusate sodium SYRUP ORAL 19901005 OTC MONOGRAPH NOT FINAL part334 Qualitest Pharmaceuticals DOCUSATE SODIUM 20 mg/5mL 0603-0823_e1c8c53f-37a0-4d74-891d-56e3ff7c26eb 0603-0823 HUMAN OTC DRUG Qdryl Allergy Diphenhydramine Hydrochloride SOLUTION ORAL 19971201 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 0603-0838_56821898-5012-4204-92cd-214f600be3ed 0603-0838 HUMAN OTC DRUG QPAP Infants Drops acetaminophen SYRUP ORAL 19971001 OTC MONOGRAPH NOT FINAL part343 Qualitest Pharmaceuticals ACETAMINOPHEN 80 mg/.8mL 0603-0839_93aac24d-dfdb-483d-b436-00bf972bad15 0603-0839 HUMAN OTC DRUG Childrens QPAP acetaminophen SOLUTION ORAL 19980301 OTC MONOGRAPH NOT FINAL part343 Qualitest Pharmaceuticals ACETAMINOPHEN 160 mg/5mL 0603-0840_344e30af-48fa-482a-99b2-e53aea4ad053 0603-0840 HUMAN OTC DRUG Childrens QPAP acetaminophen SOLUTION ORAL 19970601 OTC MONOGRAPH NOT FINAL part343 Qualitest Pharmaceuticals ACETAMINOPHEN 160 mg/5mL 0603-0841_d9b11deb-a32b-4e3d-8df6-1c30730307e6 0603-0841 HUMAN OTC DRUG Childrens QPAP acetaminophen SUSPENSION ORAL 20000901 OTC MONOGRAPH NOT FINAL part343 Qualitest Pharmaceuticals ACETAMINOPHEN 160 mg/5mL 0603-0842_9f8dd71d-a53d-4388-a540-643cf2153143 0603-0842 HUMAN OTC DRUG Childrens QPAP acetaminophen SUSPENSION ORAL 20000901 OTC MONOGRAPH NOT FINAL part343 Qualitest Pharmaceuticals ACETAMINOPHEN 160 mg/5mL 0603-0843_a2af27eb-eb04-4437-92b3-c41f159070d1 0603-0843 HUMAN OTC DRUG Childrens QPAP acetaminophen SUSPENSION ORAL 20000901 OTC MONOGRAPH NOT FINAL part343 Qualitest Pharmaceuticals ACETAMINOPHEN 160 mg/5mL 0603-0851_b29fffde-9e87-4638-b878-9bd5da195145 0603-0851 HUMAN OTC DRUG Q Tapp Cold and Allergy brompheniramine maleate and pseudoephedrine HCl LIQUID ORAL 20020403 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 15 mg/5mL; mg/5mL 0603-0852_47ed0ad5-0d35-4fc7-9a06-1cb6dde882ec 0603-0852 HUMAN OTC DRUG Q Tapp Cold and Cough Brompheniramine maleate and Dextromethorphan HBr and Pseudoephedrine HCl LIQUID ORAL 20020402 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 5; 15 mg/5mL; mg/5mL; mg/5mL 0603-0855_667aa378-d075-448d-884b-767921d31a04 0603-0855 HUMAN OTC DRUG Q Tussin DM Dextromethorphan HBr and Guaifenesin SYRUP ORAL 19950401 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 0603-0857_33aa1b23-98eb-492f-8c0c-ccfc92143766 0603-0857 HUMAN OTC DRUG QTussin Guaifenesin SOLUTION ORAL 19971001 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals GUAIFENESIN 100 mg/5mL 0603-0860_30340102-2e50-4540-91f3-0c45dbe2331a 0603-0860 HUMAN OTC DRUG Quenalin Cough Diphenhydramine hydrochloride SYRUP ORAL 19931203 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals, Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 0603-0863_d5c4b92d-6e4c-4d8e-aa97-fee4f88d2fe6 0603-0863 HUMAN OTC DRUG Q-Tapp Brompheniramine maleate and Pseudoephedrine hydrochloride ELIXIR ORAL 20010405 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 15 mg/5mL; mg/5mL 0603-0864_1e4253d6-c461-4917-96d0-1e5a22942fa0 0603-0864 HUMAN OTC DRUG Q-Tapp DM Elixir Brompheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide ELIXIR ORAL 20010405 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 5; 15 mg/5mL; mg/5mL; mg/5mL 0603-0894_9f5f56d8-93d2-4a08-b608-c9a28ffff2aa 0603-0894 HUMAN OTC DRUG Infants Simethicone Simethicone SOLUTION/ DROPS ORAL 19971016 OTC MONOGRAPH FINAL part332 Qualitest Pharmaceuticals DIMETHICONE; SILICON DIOXIDE 63.3; 3.7 mg/mL; mg/mL 0603-1008_4b72a42d-8056-4d79-a6f2-f9152cf55d07 0603-1008 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION ORAL 20061227 ANDA ANDA078105 Qualitest Pharmaceuticals ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0603-1011_890bbe6f-be06-4839-9f5e-c50b1250adc8 0603-1011 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride SOLUTION ORAL 20061212 ANDA ANDA077992 Qualitest Pharmaceuticals AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 0603-1020_7daf538e-894d-4b76-a378-59a6b3f12f23 0603-1020 HUMAN PRESCRIPTION DRUG acetaminophen and codeine phosphate acetaminophen and codeine phosphate SOLUTION ORAL 19950711 ANDA ANDA089450 Qualitest Pharmaceuticals ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 0603-1075_1fe4dbfd-4512-452e-8121-925d4de908ce 0603-1075 HUMAN OTC DRUG Cheratussin AC codeine phosphate and guaifenesin LIQUID ORAL 19960901 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 0603-1078_fba9964b-7cb7-40f3-a12f-ab805618680b 0603-1078 HUMAN OTC DRUG Cheratussin DAC codeine phosphate and guaifenesin and pseudophedrine LIQUID ORAL 19970101 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 100; 30 mg/5mL; mg/5mL; mg/5mL CV 0603-1096_ffcb6f2a-a317-4617-b28d-32e36c551ba7 0603-1096 HUMAN PRESCRIPTION DRUG Clemastine Fumarate Clemastine Fumarate SYRUP ORAL 19971217 ANDA ANDA074884 Qualitest Pharmaceuticals, Inc CLEMASTINE FUMARATE .5 mg/mL 0603-1147_0a340049-35d9-4904-bdac-42512898f2fb 0603-1147 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone ELIXIR ORAL 20110511 ANDA ANDA091188 Qualitest Pharmaceuticals DEXAMETHASONE .5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0603-1161_cdc1bd19-668a-4d08-ba5d-a0fbc673f0ac 0603-1161 HUMAN PRESCRIPTION DRUG dicyclomine hydrochloride dicyclomine hydrochloride SOLUTION ORAL 20050623 ANDA ANDA040169 Qualitest Pharmaceuticals DICYCLOMINE HYDROCHLORIDE 10 mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0603-1290_1088f3c3-7d09-49e6-8a86-e53865926ef4 0603-1290 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol SOLUTION ORAL 19930928 ANDA ANDA073364 Qualitest Pharmaceuticals HALOPERIDOL 2 mg/mL Typical Antipsychotic [EPC] 0603-1310_dbca5110-4c62-4b65-85ad-e79c7c5d0e56 0603-1310 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride SOLUTION ORAL 20020410 ANDA ANDA040391 Qualitest Pharmaceuticals HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0603-1328_15839186-ad71-436d-a35f-00b843a32337 0603-1328 HUMAN OTC DRUG Iophen NR guaifenesin LIQUID ORAL 19970501 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals GUAIFENESIN 100 mg/5mL 0603-1329_a35f44c9-e894-4d8f-9bf1-e1e660946247 0603-1329 HUMAN OTC DRUG Iophen C NR codeine phosphate and guaifenesin LIQUID ORAL 19970501 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 0603-1330_128f8c51-251e-4f3f-afb6-83f4c3b73a93 0603-1330 HUMAN OTC DRUG Iophen DM NR dextromethorphan and guaifenesin LIQUID ORAL 19970501 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals DEXTROMETHORPHAN; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 0603-1378_19100df3-5765-4f56-916c-33e40c0499c9 0603-1378 HUMAN PRESCRIPTION DRUG Lactulose lactulose SOLUTION ORAL 20010726 ANDA ANDA075993 Qualitest Pharmaceuticals LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 0603-1384_a6c308ca-6d59-4e2b-a804-93492db9ff99 0603-1384 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20120411 ANDA ANDA090079 Qualitest Pharmaceuticals LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0603-1393_f64fed20-5152-4aed-9de6-74179eeb4325 0603-1393 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION OROPHARYNGEAL 20070227 ANDA ANDA040708 Qualitest Pharmaceuticals LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0603-1394_42021371-0acd-4065-be05-3000c5a4e165 0603-1394 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION TOPICAL 20070227 ANDA ANDA040710 Qualitest Pharmaceuticals LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0603-1422_99b5e827-1621-4d22-8c49-75244081cb63 0603-1422 HUMAN PRESCRIPTION DRUG Metaproterenol Sulfate Metaproterenol Sulfate SYRUP ORAL 19920722 ANDA ANDA073632 Qualitest Pharmaceuticals, Inc, METAPROTERENOL SULFATE 10 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0603-1449_8469a2f4-2df0-409d-a078-2f8395c5fb65 0603-1449 HUMAN PRESCRIPTION DRUG Multi-Vit with Fluoride dl-alpha-tocoheryl acetate and ascorbic acid and cholecalciferol and cyanocobalamin and niacinamide and pyridoxine hydrochloride and riboflavin and fluoride and thiamin hydrochloride and vitamin A palmitate SOLUTION ORAL 19970418 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE 5; 35; 400; 2; 8; .4; .6; .25; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 0603-1450_a78b75ed-1b75-49ac-83a1-d1e3d6425a9c 0603-1450 HUMAN PRESCRIPTION DRUG Multi-Vit with Fluoride vitamin a palmitate and ascorbic acid and cholecalciferol and .alpha.-tocopherol acetate, dl- and thiamine hydrochloride and riboflavin and niacinamide and pyridoxine hydrochloride and cyanocobalamin and sodium fluoride solution SOLUTION ORAL 19970619 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE 5; 35; 400; 2; 8; .4; .6; .5; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 0603-1452_a98a2987-f985-4110-9058-9727c0687df7 0603-1452 HUMAN PRESCRIPTION DRUG Multi-Vit with Fluoride and Iron vitamin a palmitate and ascorbic acid and cholecalciferol and .alpha.-tocopherol acetate, dl- and thiamine hydrochloride and riboflavin and niacinamide and pyridoxine hydrochloride and ferrous sulfate and sodium fluoride solution SOLUTION ORAL 19980107 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; FERROUS SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE 5; 35; 400; 10; 8; .4; .6; .25; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0603-1481_20ea0a67-7dd2-4986-807f-00687f99bc03 0603-1481 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20050628 ANDA ANDA065148 Qualitest Pharmaceuticals NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 0603-1491_c310cbfb-48bb-4d46-bfdb-60dce3eaad76 0603-1491 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride SOLUTION ORAL 20041228 ANDA ANDA076682 Qualitest Pharmaceuticals OXYBUTYNIN CHLORIDE 5 mg/5mL Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0603-1508_0ca1ba53-9c24-43a3-ad7f-9fd8d7da97e7 0603-1508 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital ELIXIR ORAL 19970101 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals PHENOBARBITAL 20 mg/5mL CIV 0603-1520_96545e43-3bc3-4025-abda-68bad52035a9 0603-1520 HUMAN OTC DRUG Phenylhistine DH chlorpheniramine maleate and codeine phosphate and pseudoephedrine hcl LIQUID ORAL 19961001 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 10; 30 mg/5mL; mg/5mL; mg/5mL CV 0603-1532_cc644735-88ff-4dbe-abee-d33d86dcb806 0603-1532 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride SOLUTION ORAL 19961001 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals POTASSIUM CHLORIDE 20 meq/15mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0603-1534_cc644735-88ff-4dbe-abee-d33d86dcb806 0603-1534 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride SOLUTION ORAL 19960801 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals POTASSIUM CHLORIDE 20 meq/15mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0603-1535_cc644735-88ff-4dbe-abee-d33d86dcb806 0603-1535 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride SOLUTION ORAL 19970401 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals POTASSIUM CHLORIDE 20 meq/15mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0603-1536_cc644735-88ff-4dbe-abee-d33d86dcb806 0603-1536 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride SOLUTION ORAL 19961001 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals POTASSIUM CHLORIDE 40 meq/15mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0603-1550_bda4d588-4b8d-48cc-895b-a0eee092a703 0603-1550 HUMAN OTC DRUG Povidone Iodine povidone iodine SOLUTION TOPICAL 19950401 OTC MONOGRAPH NOT FINAL part333A Qualitest Pharmaceuticals POVIDONE-IODINE 100 mg/mL 0603-1567_d3c4b54c-f8b7-487d-a25d-d07bd846feee 0603-1567 HUMAN PRESCRIPTION DRUG PrednisoLONE Prednisolone SYRUP ORAL 20070921 ANDA ANDA040775 Qualitest Pharmaceuticals PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0603-1584_764e51f1-cfa8-4de7-b249-3fe8730f5673 0603-1584 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SYRUP ORAL 20060426 ANDA ANDA040643 Qualitest Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0603-1585_3a60c06d-b644-4719-8014-807885b62b69 0603-1585 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20060131 ANDA ANDA040650 Qualitest Pharmaceuticals CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 0603-1586_5004b187-7e0a-4538-84b3-7d513a7d0dca 0603-1586 HUMAN PRESCRIPTION DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL 20060214 ANDA ANDA040649 Qualitest Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0603-1587_c63591ee-5bab-4f30-8dc1-837b494de2af 0603-1587 HUMAN PRESCRIPTION DRUG Promethazine VC Promethazinehydrochloride and phenylephrine hydrochloride SYRUP ORAL 20061207 ANDA ANDA040654 Qualitest Pharmaceuticals PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 5; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 0603-1588_96acdd86-674c-49aa-8acb-a266befa03b6 0603-1588 HUMAN PRESCRIPTION DRUG Promethazine VC With Codeine Codeine Phosphate, Promethazine Hydrochloride, and Phenylephrine Hydrochloride SYRUP ORAL 20061207 ANDA ANDA040660 Qualitest Pharmaceuticals CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10; 5; 6.25 mg/5mL; mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] CV 0603-1684_c377b364-97e8-4cfe-b345-19da14668c4e 0603-1684 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 20070124 ANDA ANDA077785 Qualitest Pharmaceuticals SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA] 0603-1685_c377b364-97e8-4cfe-b345-19da14668c4e 0603-1685 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 20070124 ANDA ANDA077785 Qualitest Pharmaceuticals SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA] 0603-1785_7701aaf1-5d0b-4ed7-9225-b78f9e100d7e 0603-1785 HUMAN PRESCRIPTION DRUG Tri-Vit with Fluoride Drops ascorbic acid and cholecalciferol and sodium fluoride and vitamin A palmitate SOLUTION ORAL 19950401 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals ASCORBIC ACID; CHOLECALCIFEROL; SODIUM FLUORIDE; VITAMIN A PALMITATE 35; 400; .25; 1500 mg/mL; [iU]/mL; mg/mL; [iU]/mL Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0603-1786_3a7fdef4-18ec-4f13-9f5c-b689df37f6e5 0603-1786 HUMAN PRESCRIPTION DRUG Tri-Vit with Fluoride Drops ascorbic acid and chlolecalciferol and sodium fluorideand vitamin A plamitate SOLUTION ORAL 19950401 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals ASCORBIC ACID; CHOLECALCIFEROL; SODIUM FLUORIDE; VITAMIN A PALMITATE 35; 400; .5; 1500 mg/mL; [iU]/mL; mg/mL; [iU]/mL Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0603-1787_0053a17a-f56f-43e2-810d-8c41a9376d14 0603-1787 HUMAN PRESCRIPTION DRUG Tri-Vit With Fluoride And Iron Drops vitamin a palmitate and ascorbic acid and cholecalciferol and ferrous sulfate and sodium fluoride solution SOLUTION ORAL 19971117 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals ASCORBIC ACID; CHOLECALCIFEROL; FERROUS SULFATE; SODIUM FLUORIDE; VITAMIN A PALMITATE 35; 400; 10; .25; 1500 mg/mL; [iU]/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0603-1841_c4c9b736-5f0d-4cf3-b399-4b4bee2ef028 0603-1841 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid SOLUTION ORAL 20061013 ANDA ANDA077960 Qualitest Pharmaceuticals VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0603-1880_e9d53558-11ec-4622-920d-ca1aef541ef8 0603-1880 HUMAN PRESCRIPTION DRUG Lidocaine lidocaine PATCH CUTANEOUS 20140502 NDA AUTHORIZED GENERIC NDA020612 Qualitest Pharmaceuticals LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 0603-2108_0f392c06-3d6a-47af-ab70-13a8999f2177 0603-2108 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Qualitest Pharmaceuticals AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0603-2109_0f392c06-3d6a-47af-ab70-13a8999f2177 0603-2109 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Qualitest Pharmaceuticals AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0603-2110_0f392c06-3d6a-47af-ab70-13a8999f2177 0603-2110 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Qualitest Pharmaceuticals AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0603-2115_e376f67b-c2e9-43e4-b957-0f7167bcc344 0603-2115 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Qualitest Pharmaceuticals ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 0603-2116_e376f67b-c2e9-43e4-b957-0f7167bcc344 0603-2116 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Qualitest Pharmaceuticals ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 0603-2127_fdc491c5-e236-424e-a6c9-f261f6fb774f 0603-2127 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20080925 ANDA ANDA078491 Qualitest Pharmaceuticals ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0603-2128_fdc491c5-e236-424e-a6c9-f261f6fb774f 0603-2128 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20080925 ANDA ANDA078491 Qualitest Pharmaceuticals ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0603-2129_fdc491c5-e236-424e-a6c9-f261f6fb774f 0603-2129 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20080925 ANDA ANDA078491 Qualitest Pharmaceuticals ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0603-2130_fdc491c5-e236-424e-a6c9-f261f6fb774f 0603-2130 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20080925 ANDA ANDA078491 Qualitest Pharmaceuticals ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0603-2212_2881e2bb-ffa7-4799-9daa-25b7b0fd9f7a 0603-2212 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Qualitest Pharmaceuticals AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0603-2213_2881e2bb-ffa7-4799-9daa-25b7b0fd9f7a 0603-2213 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Qualitest Pharmaceuticals AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0603-2214_2881e2bb-ffa7-4799-9daa-25b7b0fd9f7a 0603-2214 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Qualitest Pharmaceuticals AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0603-2215_2881e2bb-ffa7-4799-9daa-25b7b0fd9f7a 0603-2215 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Qualitest Pharmaceuticals AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 0603-2216_2881e2bb-ffa7-4799-9daa-25b7b0fd9f7a 0603-2216 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Qualitest Pharmaceuticals AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 0603-2217_2881e2bb-ffa7-4799-9daa-25b7b0fd9f7a 0603-2217 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Qualitest Pharmaceuticals AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 0603-2337_d81ece44-7c7b-4732-8079-16b7760b7687 0603-2337 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089990 Qualitest Pharmaceuticals ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0603-2338_259df8bc-84e9-4375-8461-76ea0a1120aa 0603-2338 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 Qualitest Pharmaceuticals ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0603-2339_259df8bc-84e9-4375-8461-76ea0a1120aa 0603-2339 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089828 Qualitest Pharmaceuticals ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0603-2406_a4430ab4-367b-4e6b-ac56-21f6cd5eda6c 0603-2406 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077156 Qualitest Pharmaceuticals BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 0603-2407_a4430ab4-367b-4e6b-ac56-21f6cd5eda6c 0603-2407 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077068 Qualitest Pharmaceuticals BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 0603-2433_24b83f2b-4832-47be-9616-ee25b42235a0 0603-2433 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040738 Qualitest Pharmaceuticals BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0603-2434_24b83f2b-4832-47be-9616-ee25b42235a0 0603-2434 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040742 Qualitest Pharmaceuticals BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0603-2435_24b83f2b-4832-47be-9616-ee25b42235a0 0603-2435 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040715 Qualitest Pharmaceuticals BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0603-2483_61e295df-0ed2-4d60-87f0-a60807301183 0603-2483 HUMAN OTC DRUG Bisacodyl bisacodyl TABLET, DELAYED RELEASE ORAL 20050708 OTC MONOGRAPH NOT FINAL part334 Qualitest Pharmaceuticals BISACODYL 5 mg/1 0603-2540_e619b656-4123-4878-b601-b0edad3c428b 0603-2540 HUMAN PRESCRIPTION DRUG butalbital and acetaminophen butalbital and acetaminophen TABLET ORAL 19990603 ANDA ANDA089987 Qualitest Pharmaceuticals ACETAMINOPHEN; BUTALBITAL 325; 50 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] 0603-2544_75a27640-6e55-4d87-bb69-200ea85e1e8e 0603-2544 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030827 ANDA ANDA040511 Qualitest Pharmaceuticals ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0603-2548_b583d509-72c1-44b0-87b6-3785c8b33dff 0603-2548 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Tablets Bultabital, Aspirin and Caffeine Tablets TABLET ORAL 19790605 ANDA ANDA086162 Qualitest ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 0603-2553_e430f81e-b319-43fd-8913-1a5708acb6b5 0603-2553 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE ORAL 20020422 ANDA ANDA075929 Qualitest Pharmaceuticals ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0603-2582_6251e0ad-7ccb-45bf-8263-bcb044f88a44 0603-2582 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 Qualitest Pharmaceuticals CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 0603-2948_405ab3a4-e758-477c-a987-8f45cf6e272e 0603-2948 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Qualitest Pharmaceuticals CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0603-2949_405ab3a4-e758-477c-a987-8f45cf6e272e 0603-2949 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Qualitest Pharmaceuticals CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0603-2950_405ab3a4-e758-477c-a987-8f45cf6e272e 0603-2950 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Qualitest Pharmaceuticals CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0603-2957_326d998a-ebab-4b6e-9a38-6bf45f2e82e2 0603-2957 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Qualitest Pharmaceuticals CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0603-2958_326d998a-ebab-4b6e-9a38-6bf45f2e82e2 0603-2958 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Qualitest Pharmaceuticals CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0603-2959_326d998a-ebab-4b6e-9a38-6bf45f2e82e2 0603-2959 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Qualitest Pharmaceuticals CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0603-3078_f6eafe69-81e1-466e-8301-a303b4d23651 0603-3078 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 Qualitest Pharmaceuticals CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0603-3079_f6eafe69-81e1-466e-8301-a303b4d23651 0603-3079 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 Qualitest Pharmaceuticals CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0603-3162_f4a35af4-d26d-4434-a879-b7b86000d3cf 0603-3162 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20100604 ANDA ANDA040756 Qualitest Pharmaceuticals FOLIC ACID 1 mg/1 0603-3180_2d1db3b9-193d-4877-b4fe-c9053fb212af 0603-3180 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20081229 ANDA ANDA040821 Qualitest Pharmaceuticals GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0603-3181_2d1db3b9-193d-4877-b4fe-c9053fb212af 0603-3181 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20081229 ANDA ANDA040821 Qualitest Pharmaceuticals GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0603-3213_e94f9c1c-dafa-4d65-af08-57880778a6a1 0603-3213 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Qualitest Pharmaceuticals DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0603-3214_e94f9c1c-dafa-4d65-af08-57880778a6a1 0603-3214 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Qualitest Pharmaceuticals DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0603-3215_e94f9c1c-dafa-4d65-af08-57880778a6a1 0603-3215 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Qualitest Pharmaceuticals DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0603-3327_ec450ba6-f03d-4820-8dbe-0a8e0227ce26 0603-3327 HUMAN OTC DRUG Dimenhydrinate Dimenhydrinate TABLET ORAL 20040301 OTC MONOGRAPH FINAL part336 Qualitest Pharmaceuticals DIMENHYDRINATE 50 mg/1 0603-3339_723b75cb-74e6-46eb-a23a-4f0160dfdac9 0603-3339 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0603-3340_b8c798b1-692b-4411-b5ac-16a40d369150 0603-3340 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 0603-3432_e3a73e8f-2ad7-4140-a727-5653101fe46b 0603-3432 HUMAN PRESCRIPTION DRUG Disulfiram disulfiram TABLET ORAL 20121231 ANDA ANDA091563 Qualitest Pharmaceuticals DISULFIRAM 500 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] 0603-3433_e3a73e8f-2ad7-4140-a727-5653101fe46b 0603-3433 HUMAN PRESCRIPTION DRUG Disulfiram disulfiram TABLET ORAL 20121231 ANDA ANDA091563 Qualitest Pharmaceuticals DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] 0603-3441_8922d19a-8add-463c-b35c-37a822f8a17f 0603-3441 HUMAN PRESCRIPTION DRUG Divalproex Sodium Delayed-Release Divalproex Sodium TABLET, FILM COATED ORAL 20091130 ANDA ANDA090210 Qualitest Pharmaceuticals DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0603-3442_8922d19a-8add-463c-b35c-37a822f8a17f 0603-3442 HUMAN PRESCRIPTION DRUG Divalproex Sodium Delayed-Release Divalproex Sodium TABLET, FILM COATED ORAL 20091130 ANDA ANDA090210 Qualitest Pharmaceuticals DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0603-3443_8922d19a-8add-463c-b35c-37a822f8a17f 0603-3443 HUMAN PRESCRIPTION DRUG Divalproex Sodium Delayed-Release Divalproex Sodium TABLET, FILM COATED ORAL 20091130 ANDA ANDA090210 Qualitest Pharmaceuticals DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0603-3508_fc94a381-48f4-471f-be58-94e7924fd289 0603-3508 HUMAN PRESCRIPTION DRUG Effervescent Potassium Chloride Potassium Bicarbonate and Potassium Chloride Effervescent Tablets for Oral Solution TABLET, EFFERVESCENT ORAL 20060106 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals LYSINE HYDROCHLORIDE; POTASSIUM BICARBONATE; POTASSIUM CHLORIDE 1.5; .7; 1.25 g/1; g/1; g/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0603-3581_caa21eb5-24a9-444a-82e4-230a9eb24794 0603-3581 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20090331 ANDA ANDA200815 Qualitest Pharmaceuticals FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0603-3582_caa21eb5-24a9-444a-82e4-230a9eb24794 0603-3582 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20111215 ANDA ANDA200815 Qualitest Pharmaceuticals FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0603-3583_caa21eb5-24a9-444a-82e4-230a9eb24794 0603-3583 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111215 ANDA ANDA200815 Qualitest Pharmaceuticals FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0603-3590_8dd4dd87-16e6-4a1c-a565-3c5eb4a7a374 0603-3590 HUMAN PRESCRIPTION DRUG Gildagia norethindrone and ethinyl estradiol KIT 20121223 ANDA ANDA078376 Qualitest Pharmaceuticals 0603-3633_ff5d398d-ecda-4ee6-b715-7c2e8ec6e06c 0603-3633 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20061222 ANDA ANDA077251 Qualitest Pharmaceuticals FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 0603-3714_5be85f98-2903-4ee7-b56b-b9dc6c7b1b1a 0603-3714 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 19720331 ANDA ANDA080600 Qualitest FOLIC ACID 1 mg/1 0603-3739_dc96d21d-a2ad-4126-8e11-81837c629a3a 0603-3739 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 Qualitest Pharmaceuticals FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0603-3740_dc96d21d-a2ad-4126-8e11-81837c629a3a 0603-3740 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 Qualitest Pharmaceuticals FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0603-3741_dc96d21d-a2ad-4126-8e11-81837c629a3a 0603-3741 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 Qualitest Pharmaceuticals FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0603-3744_03b7ff00-1f40-480a-8259-3acc90412f18 0603-3744 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20101014 ANDA ANDA077370 Qualitest Pharmaceuticals GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0603-3745_03b7ff00-1f40-480a-8259-3acc90412f18 0603-3745 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20101014 ANDA ANDA077370 Qualitest Pharmaceuticals GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0603-3746_03b7ff00-1f40-480a-8259-3acc90412f18 0603-3746 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20101014 ANDA ANDA077370 Qualitest Pharmaceuticals GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0603-3842_9588399a-d426-48c4-829c-c18f03aa5784 0603-3842 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20101215 ANDA ANDA091491 Qualitest Pharmaceuticals LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0603-3843_9588399a-d426-48c4-829c-c18f03aa5784 0603-3843 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20101215 ANDA ANDA091491 Qualitest Pharmaceuticals LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0603-3844_9588399a-d426-48c4-829c-c18f03aa5784 0603-3844 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20101215 ANDA ANDA091491 Qualitest Pharmaceuticals LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0603-3845_9588399a-d426-48c4-829c-c18f03aa5784 0603-3845 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20101215 ANDA ANDA091491 Qualitest Pharmaceuticals LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0603-3855_c467a192-079d-4cc1-91a7-61faa6982e26 0603-3855 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20020917 ANDA ANDA075907 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0603-3856_3eeb55a8-8647-4fdd-8fc7-f51eb9789184 0603-3856 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0603-3857_3eeb55a8-8647-4fdd-8fc7-f51eb9789184 0603-3857 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0603-3887_8ed3248e-e39e-4ca7-9c96-ab1f50f97062 0603-3887 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 Qualitest Pharmaceuticals ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0603-3890_8ed3248e-e39e-4ca7-9c96-ab1f50f97062 0603-3890 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 Qualitest Pharmaceuticals ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0603-3891_8ed3248e-e39e-4ca7-9c96-ab1f50f97062 0603-3891 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Qualitest Pharmaceuticals ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0603-3897_0c9c70cd-bb36-4628-8e0b-653889cc1023 0603-3897 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20061106 ANDA ANDA077723 Qualitest Pharmaceuticals HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 0603-3899_a449b07a-e969-4879-9f00-9dfd57c33b60 0603-3899 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20070716 ANDA ANDA040761 Qualitest Pharmaceuticals HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0603-3900_a449b07a-e969-4879-9f00-9dfd57c33b60 0603-3900 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20070716 ANDA ANDA040761 Qualitest Pharmaceuticals HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0603-3901_a449b07a-e969-4879-9f00-9dfd57c33b60 0603-3901 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20070716 ANDA ANDA040761 Qualitest Pharmaceuticals HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0603-3967_ead5c90a-0d93-434b-8a30-aab4771069b1 0603-3967 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20050527 ANDA ANDA040579 Qualitest Pharmaceuticals HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0603-3968_ead5c90a-0d93-434b-8a30-aab4771069b1 0603-3968 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20050527 ANDA ANDA040574 Qualitest Pharmaceuticals HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0603-3969_ead5c90a-0d93-434b-8a30-aab4771069b1 0603-3969 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20050527 ANDA ANDA040580 Qualitest Pharmaceuticals HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0603-4021_463e438a-4ecd-4e57-84d0-0f24fad8a866 0603-4021 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Qualitest Pharmaceuticals IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0603-4022_463e438a-4ecd-4e57-84d0-0f24fad8a866 0603-4022 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Qualitest Pharmaceuticals IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0603-4023_463e438a-4ecd-4e57-84d0-0f24fad8a866 0603-4023 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Qualitest Pharmaceuticals IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0603-4080_40035f75-61d7-4b86-bb3c-317c3c594262 0603-4080 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120930 ANDA ANDA091236 Qualitest Pharmaceuticals IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0603-4081_40035f75-61d7-4b86-bb3c-317c3c594262 0603-4081 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120930 ANDA ANDA091236 Qualitest Pharmaceuticals IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0603-4082_40035f75-61d7-4b86-bb3c-317c3c594262 0603-4082 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120930 ANDA ANDA091236 Qualitest Pharmaceuticals IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0603-4088_0306b6d7-7d3b-4a50-9a17-cabf05141435 0603-4088 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20120930 ANDA ANDA091370 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0603-4089_0306b6d7-7d3b-4a50-9a17-cabf05141435 0603-4089 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20120930 ANDA ANDA091370 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0603-4110_373438d1-c664-46fe-b16d-72301399b477 0603-4110 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100811 ANDA ANDA090598 Qualitest Pharmaceuticals ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0603-4111_373438d1-c664-46fe-b16d-72301399b477 0603-4111 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100811 ANDA ANDA090598 Qualitest Pharmaceuticals ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0603-4112_373438d1-c664-46fe-b16d-72301399b477 0603-4112 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100811 ANDA ANDA090598 Qualitest Pharmaceuticals ISOSORBIDE MONONITRATE 120 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0603-4170_ecdd65cd-25d6-401a-b925-fb1652999167 0603-4170 HUMAN PRESCRIPTION DRUG K-EFFERVESCENT POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20060106 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals POTASSIUM BICARBONATE 25 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0603-4180_5f86e64d-2e9d-4e71-9691-653cff33aebb 0603-4180 HUMAN PRESCRIPTION DRUG Letrozole LETROZOLE TABLET, COATED ORAL 20110603 ANDA ANDA090789 Qualitest Pharmaceuticals LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 0603-4186_e12fc996-1b05-4000-b197-1150b95d3c42 0603-4186 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120720 ANDA ANDA202533 Qualitest Pharmaceuticals LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0603-4187_e12fc996-1b05-4000-b197-1150b95d3c42 0603-4187 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120720 ANDA ANDA202533 Qualitest Pharmaceuticals LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0603-4209_7b170a01-a614-48e0-89e7-6e49d49e85ea 0603-4209 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Qualitest Pharmaceuticals LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0603-4210_7b170a01-a614-48e0-89e7-6e49d49e85ea 0603-4210 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Qualitest Pharmaceuticals LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0603-4211_7b170a01-a614-48e0-89e7-6e49d49e85ea 0603-4211 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Qualitest Pharmaceuticals LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0603-4212_7b170a01-a614-48e0-89e7-6e49d49e85ea 0603-4212 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Qualitest Pharmaceuticals LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0603-4213_7b170a01-a614-48e0-89e7-6e49d49e85ea 0603-4213 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Qualitest Pharmaceuticals LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0603-4214_7b170a01-a614-48e0-89e7-6e49d49e85ea 0603-4214 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Qualitest Pharmaceuticals LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0603-4224_b4805122-bb66-47c2-a896-51f387866f12 0603-4224 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20120104 ANDA ANDA090428 Qualitest Pharmaceuticals LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0603-4225_b4805122-bb66-47c2-a896-51f387866f12 0603-4225 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20120104 ANDA ANDA090428 Qualitest Pharmaceuticals LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0603-4226_b4805122-bb66-47c2-a896-51f387866f12 0603-4226 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20120104 ANDA ANDA090428 Qualitest Pharmaceuticals LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0603-4228_beb88dd5-948b-4e15-ae98-a4b472320e7e 0603-4228 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130215 ANDA ANDA091617 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0603-4229_beb88dd5-948b-4e15-ae98-a4b472320e7e 0603-4229 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130215 ANDA ANDA091617 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0603-4230_beb88dd5-948b-4e15-ae98-a4b472320e7e 0603-4230 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130215 ANDA ANDA091617 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0603-4246_55aaf4f2-b8e7-4292-96a5-2fc9cc553d48 0603-4246 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20060510 ANDA ANDA077754 Qualitest Pharmaceuticals LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0603-4247_55aaf4f2-b8e7-4292-96a5-2fc9cc553d48 0603-4247 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20060510 ANDA ANDA077754 Qualitest Pharmaceuticals LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0603-4248_55aaf4f2-b8e7-4292-96a5-2fc9cc553d48 0603-4248 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20060510 ANDA ANDA077754 Qualitest Pharmaceuticals LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0603-4372_7ab53c06-5f81-4c3e-94b1-4e3119c93c20 0603-4372 HUMAN PRESCRIPTION DRUG Mefenamic Acid Mefenamic Acid CAPSULE ORAL 20140602 ANDA ANDA091608 Qualitest Pharmaceuticals MEFENAMIC ACID 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0603-4381_9c0105e7-b917-4b83-900a-61cee911d66b 0603-4381 HUMAN PRESCRIPTION DRUG Multi Vitamin with Fluoride Multi Vitamin with Fluoride TABLET, CHEWABLE ORAL 20091009 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A ACETATE 15; 24; 400; 4.5; .3; 13.5; 1.05; 1.2; 36; .25; 1.05; 2500 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 0603-4382_9c0105e7-b917-4b83-900a-61cee911d66b 0603-4382 HUMAN PRESCRIPTION DRUG Multi Vitamin with Fluoride Multi Vitamin with Fluoride TABLET, CHEWABLE ORAL 20091009 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A ACETATE 15; 24; 400; 4.5; .3; 13.5; 1.05; 1.2; 36; .5; 1.05; 2500 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 0603-4383_9c0105e7-b917-4b83-900a-61cee911d66b 0603-4383 HUMAN PRESCRIPTION DRUG Multi Vitamin with Fluoride Multi Vitamin with Fluoride TABLET, CHEWABLE ORAL 20091009 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A ACETATE 15; 24; 400; 4.5; .3; 13.5; 1.05; 1.2; 36; 1; 1.05; 2500 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 0603-4415_40adee71-c160-45a4-8e1c-e585899a8875 0603-4415 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 19981217 ANDA ANDA040191 Qualitest Pharmaceuticals MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0603-4416_40adee71-c160-45a4-8e1c-e585899a8875 0603-4416 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 19981217 ANDA ANDA040191 Qualitest Pharmaceuticals MEPERIDINE HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0603-4467_b720d8d3-b2e6-4a5d-9da0-eed9e2b2ac64 0603-4467 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20060728 ANDA ANDA077853 Qualitest Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0603-4468_b720d8d3-b2e6-4a5d-9da0-eed9e2b2ac64 0603-4468 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20060728 ANDA ANDA077853 Qualitest Pharmaceuticals METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0603-4469_b720d8d3-b2e6-4a5d-9da0-eed9e2b2ac64 0603-4469 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20060728 ANDA ANDA077853 Qualitest Pharmaceuticals METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0603-4485_a4bf3eec-15e9-47e5-8a04-8e81c53c83aa 0603-4485 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Qualitest Pharmaceuticals METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0603-4486_a4bf3eec-15e9-47e5-8a04-8e81c53c83aa 0603-4486 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Qualitest Pharmaceuticals METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0603-4576_1bb3e33c-1a00-45b4-84b7-01f4fb75b1f6 0603-4576 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 20140923 ANDA ANDA202892 Qualitest Pharmaceuticals METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0603-4577_1bb3e33c-1a00-45b4-84b7-01f4fb75b1f6 0603-4577 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 20140923 ANDA ANDA202892 Qualitest Pharmaceuticals METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0603-4578_1bb3e33c-1a00-45b4-84b7-01f4fb75b1f6 0603-4578 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 20140923 ANDA ANDA202892 Qualitest Pharmaceuticals METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0603-4593_b1a9244a-d083-4a31-845b-919042da3792 0603-4593 HUMAN PRESCRIPTION DRUG MethylPREDNISolone methylprednisolone TABLET ORAL 19981222 ANDA ANDA040183 Qualitest Pharmaceuticals METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0603-4614_262e2632-e332-4c99-ad85-7b2168ef6a8b 0603-4614 HUMAN PRESCRIPTION DRUG Metoclopramide metoclopramide TABLET ORAL 20060828 ANDA ANDA077878 Qualitest Pharmaceuticals METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0603-4615_262e2632-e332-4c99-ad85-7b2168ef6a8b 0603-4615 HUMAN PRESCRIPTION DRUG Metoclopramide metoclopramide TABLET ORAL 20060828 ANDA ANDA077878 Qualitest Pharmaceuticals METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0603-4653_0d31e5b3-ea55-4a66-a177-20c469d267db 0603-4653 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA091588 Qualitest Pharmaceuticals MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0603-4654_0d31e5b3-ea55-4a66-a177-20c469d267db 0603-4654 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA091588 Qualitest Pharmaceuticals MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0603-4655_0d31e5b3-ea55-4a66-a177-20c469d267db 0603-4655 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA091576 Qualitest Pharmaceuticals MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0603-4661_6f92c0e7-4a10-4a0d-a69a-a994f4fb1f32 0603-4661 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20130129 ANDA ANDA202700 Qualitest Pharmaceuticals MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] 0603-4662_6f92c0e7-4a10-4a0d-a69a-a994f4fb1f32 0603-4662 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20130129 ANDA ANDA202700 Qualitest Pharmaceuticals MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] 0603-4886_aa5bcea9-3f63-438e-8647-b6f8e041a8ee 0603-4886 HUMAN OTC DRUG ORGAN-I NR guaifenesin TABLET ORAL 20020701 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals GUAIFENESIN 200 mg/1 0603-4975_f375cd31-a564-48f2-906a-0f593a716b22 0603-4975 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 19971031 ANDA ANDA075079 Qualitest Pharmaceuticals OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0603-4978_ed641719-d5db-44f7-aa4f-4c101333f5f8 0603-4978 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20130711 ANDA ANDA090733 Qualitest Pharmaceuticals ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 2.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0603-4979_f470292c-1346-4195-bb81-6aea1b07c1da 0603-4979 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20130711 ANDA ANDA090734 Qualitest Pharmaceuticals ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0603-4982_f470292c-1346-4195-bb81-6aea1b07c1da 0603-4982 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20130711 ANDA ANDA090734 Qualitest Pharmaceuticals ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0603-4990_d920db34-a887-419e-9996-a27cc23f91ae 0603-4990 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20090302 ANDA ANDA077712 Qualitest Pharmaceuticals OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0603-4991_d920db34-a887-419e-9996-a27cc23f91ae 0603-4991 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20070131 ANDA ANDA077712 Qualitest Pharmaceuticals OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0603-4992_d920db34-a887-419e-9996-a27cc23f91ae 0603-4992 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20070131 ANDA ANDA077712 Qualitest Pharmaceuticals OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0603-4998_1525cfbe-bddd-4ea4-95d1-79f97fc958c2 0603-4998 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 19960730 ANDA ANDA040105 Qualitest Pharmaceuticals ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0603-5060_98f9c536-f4a0-4eb9-9749-2e1c24cb9136 0603-5060 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Qualitest Pharmaceuticals PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0603-5061_98f9c536-f4a0-4eb9-9749-2e1c24cb9136 0603-5061 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Qualitest Pharmaceuticals PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0603-5062_98f9c536-f4a0-4eb9-9749-2e1c24cb9136 0603-5062 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Qualitest Pharmaceuticals PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0603-5063_98f9c536-f4a0-4eb9-9749-2e1c24cb9136 0603-5063 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Qualitest Pharmaceuticals PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0603-5165_fd869ccd-d428-46db-919d-6c446a688505 0603-5165 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20020301 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals PHENOBARBITAL 16.2 mg/1 CIV 0603-5166_fd869ccd-d428-46db-919d-6c446a688505 0603-5166 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20030201 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals PHENOBARBITAL 32.4 mg/1 CIV 0603-5167_fd869ccd-d428-46db-919d-6c446a688505 0603-5167 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20011201 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals PHENOBARBITAL 64.8 mg/1 CIV 0603-5168_fd869ccd-d428-46db-919d-6c446a688505 0603-5168 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20011201 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals PHENOBARBITAL 97.2 mg/1 CIV 0603-5192_26055736-0f73-4795-8f78-9683782d0fd8 0603-5192 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20020104 ANDA ANDA040377 Qualitest Pharmaceuticals PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 0603-5335_9a0d8ce6-38d2-452a-a316-39d6a745decb 0603-5335 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20041221 ANDA ANDA040584 Qualitest Pharmaceuticals PREDNISONE 1 mg/1 0603-5336_9a0d8ce6-38d2-452a-a316-39d6a745decb 0603-5336 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20041221 ANDA ANDA040581 Qualitest Pharmaceuticals PREDNISONE 2.5 mg/1 0603-5337_9a0d8ce6-38d2-452a-a316-39d6a745decb 0603-5337 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Qualitest Pharmaceuticals PREDNISONE 5 mg/1 0603-5338_9a0d8ce6-38d2-452a-a316-39d6a745decb 0603-5338 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Qualitest Pharmaceuticals PREDNISONE 10 mg/1 0603-5339_9a0d8ce6-38d2-452a-a316-39d6a745decb 0603-5339 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 Qualitest Pharmaceuticals PREDNISONE 20 mg/1 0603-5371_c61fd8e4-38e6-4d4c-9c4f-8258abeed1f4 0603-5371 HUMAN PRESCRIPTION DRUG Primidone primidone TABLET ORAL 20050224 ANDA ANDA040586 Qualitest Pharmaceuticals PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0603-5372_c61fd8e4-38e6-4d4c-9c4f-8258abeed1f4 0603-5372 HUMAN PRESCRIPTION DRUG Primidone primidone TABLET ORAL 20050224 ANDA ANDA040586 Qualitest Pharmaceuticals PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0603-5437_0a7957b1-fb04-4925-a60a-53e213e4ad77 0603-5437 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20060718 ANDA ANDA040622 Qualitest Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0603-5438_0a7957b1-fb04-4925-a60a-53e213e4ad77 0603-5438 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20060718 ANDA ANDA040622 Qualitest Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0603-5439_0a7957b1-fb04-4925-a60a-53e213e4ad77 0603-5439 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20060718 ANDA ANDA040622 Qualitest Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0603-5448_31ff5ec3-5e90-47df-9769-bd34cb9cadc5 0603-5448 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride Propafenone Hydrochloride TABLET, FILM COATED ORAL 20021017 ANDA ANDA075938 Qualitest Pharmaceuticals PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] 0603-5449_31ff5ec3-5e90-47df-9769-bd34cb9cadc5 0603-5449 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride Propafenone Hydrochloride TABLET, FILM COATED ORAL 20021017 ANDA ANDA075938 Qualitest Pharmaceuticals PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] 0603-5450_31ff5ec3-5e90-47df-9769-bd34cb9cadc5 0603-5450 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride Propafenone Hydrochloride TABLET, FILM COATED ORAL 20021017 ANDA ANDA075938 Qualitest Pharmaceuticals PROPAFENONE HYDROCHLORIDE 300 mg/1 Antiarrhythmic [EPC] 0603-5482_10af9ce9-468b-40e8-837e-891fed9d316f 0603-5482 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070217 Qualitest Pharmaceuticals PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0603-5483_10af9ce9-468b-40e8-837e-891fed9d316f 0603-5483 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070218 Qualitest Pharmaceuticals PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0603-5484_10af9ce9-468b-40e8-837e-891fed9d316f 0603-5484 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070219 Qualitest Pharmaceuticals PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0603-5485_10af9ce9-468b-40e8-837e-891fed9d316f 0603-5485 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070220 Qualitest Pharmaceuticals PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0603-5486_10af9ce9-468b-40e8-837e-891fed9d316f 0603-5486 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070221 Qualitest Pharmaceuticals PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0603-5683_c4173c48-5019-430b-89d1-cec590ffab18 0603-5683 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Qualitest Pharmaceuticals RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 0603-5684_c4173c48-5019-430b-89d1-cec590ffab18 0603-5684 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Qualitest Pharmaceuticals RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 0603-5685_c4173c48-5019-430b-89d1-cec590ffab18 0603-5685 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Qualitest Pharmaceuticals RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 0603-5686_c4173c48-5019-430b-89d1-cec590ffab18 0603-5686 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Qualitest Pharmaceuticals RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 0603-5688_c4173c48-5019-430b-89d1-cec590ffab18 0603-5688 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Qualitest Pharmaceuticals RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 0603-5689_c4173c48-5019-430b-89d1-cec590ffab18 0603-5689 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Qualitest Pharmaceuticals RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 0603-5763_1a2c363c-e1fb-46c8-80e0-0c6f6a8595af 0603-5763 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Qualitest Pharmaceuticals SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0603-5764_1a2c363c-e1fb-46c8-80e0-0c6f6a8595af 0603-5764 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Qualitest Pharmaceuticals SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0603-5765_1a2c363c-e1fb-46c8-80e0-0c6f6a8595af 0603-5765 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Qualitest Pharmaceuticals SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0603-5769_cb09c076-6f11-4e5e-b6af-5b9593d4c0bf 0603-5769 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Qualitest Pharmaceuticals SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 0603-5770_cb09c076-6f11-4e5e-b6af-5b9593d4c0bf 0603-5770 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Qualitest Pharmaceuticals SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC] 0603-5771_cb09c076-6f11-4e5e-b6af-5b9593d4c0bf 0603-5771 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Qualitest Pharmaceuticals SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC] 0603-5772_cb09c076-6f11-4e5e-b6af-5b9593d4c0bf 0603-5772 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Qualitest Pharmaceuticals SOTALOL HYDROCHLORIDE 240 mg/1 Antiarrhythmic [EPC] 0603-5780_86583d17-618a-431e-8613-0b449dcbfc43 0603-5780 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20070125 ANDA ANDA078060 Qualitest Pharmaceuticals SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0603-5781_86583d17-618a-431e-8613-0b449dcbfc43 0603-5781 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20070125 ANDA ANDA078060 Qualitest Pharmaceuticals SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0603-5801_73e36f2e-23ee-405f-afbf-798391f6b7b8 0603-5801 HUMAN PRESCRIPTION DRUG Sulfasalazine sulfasalazine TABLET ORAL 20020111 ANDA ANDA040349 Qualitest Pharmaceuticals SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 0603-5803_61a8a9c0-c9c5-46f5-ab21-5ada9dc3a07c 0603-5803 HUMAN PRESCRIPTION DRUG Sulfasalazine Delayed-Release sulfasalazine TABLET, DELAYED RELEASE ORAL 20020111 ANDA ANDA075339 Qualitest Pharmaceuticals SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 0603-5914_94f113ed-a5f1-441c-af30-b1120883a45d 0603-5914 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20130306 ANDA ANDA202130 Qualitest Pharmaceuticals TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0603-5915_94f113ed-a5f1-441c-af30-b1120883a45d 0603-5915 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20130306 ANDA ANDA202130 Qualitest Pharmaceuticals TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0603-5916_94f113ed-a5f1-441c-af30-b1120883a45d 0603-5916 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20130306 ANDA ANDA202130 Qualitest Pharmaceuticals TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0603-5926_adc7952c-1462-4245-9866-31cf62788cd0 0603-5926 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide 40 mg/12.5 mg Telmisartan and Hydrochlorothiazide TABLET ORAL 20140227 ANDA ANDA203010 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0603-5927_adc7952c-1462-4245-9866-31cf62788cd0 0603-5927 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg Telmisartan and Hydrochlorothiazide TABLET ORAL 20140227 ANDA ANDA203010 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0603-5928_adc7952c-1462-4245-9866-31cf62788cd0 0603-5928 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide 80 mg/25 mg Telmisartan and Hydrochlorothiazide TABLET ORAL 20140227 ANDA ANDA203010 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE; TELMISARTAN 25; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0603-6134_96e10b5f-bd2d-40ac-867e-d87e7ec551c1 0603-6134 HUMAN PRESCRIPTION DRUG Torsemide torsemide TABLET ORAL 20110322 ANDA ANDA090613 Qualitest Pharmaceuticals TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0603-6135_96e10b5f-bd2d-40ac-867e-d87e7ec551c1 0603-6135 HUMAN PRESCRIPTION DRUG Torsemide torsemide TABLET ORAL 20110322 ANDA ANDA090613 Qualitest Pharmaceuticals TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0603-6136_96e10b5f-bd2d-40ac-867e-d87e7ec551c1 0603-6136 HUMAN PRESCRIPTION DRUG Torsemide torsemide TABLET ORAL 20110322 ANDA ANDA090613 Qualitest Pharmaceuticals TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0603-6137_96e10b5f-bd2d-40ac-867e-d87e7ec551c1 0603-6137 HUMAN PRESCRIPTION DRUG Torsemide torsemide TABLET ORAL 20110322 ANDA ANDA090613 Qualitest Pharmaceuticals TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0603-6149_be27ee3e-56a6-4c2d-a1ce-efec55709d25 0603-6149 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20100804 ANDA ANDA090027 Qualitest Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0603-6150_be27ee3e-56a6-4c2d-a1ce-efec55709d25 0603-6150 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20100804 ANDA ANDA090027 Qualitest Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0603-6151_be27ee3e-56a6-4c2d-a1ce-efec55709d25 0603-6151 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20100804 ANDA ANDA090027 Qualitest Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0603-6156_be27ee3e-56a6-4c2d-a1ce-efec55709d25 0603-6156 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20100804 ANDA ANDA090027 Qualitest Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0603-6157_be27ee3e-56a6-4c2d-a1ce-efec55709d25 0603-6157 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20100804 ANDA ANDA090027 Qualitest Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0603-6160_6191b734-1e21-48e5-8751-c02e85cac9e6 0603-6160 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072192 Qualitest Pharmaceuticals TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 0603-6161_6191b734-1e21-48e5-8751-c02e85cac9e6 0603-6161 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072193 Qualitest Pharmaceuticals TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 0603-6240_8a52e957-557c-40f3-b68c-f8da6ac84bcb 0603-6240 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 19981224 ANDA ANDA040254 Qualitest Pharmaceuticals TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 0603-6241_8a52e957-557c-40f3-b68c-f8da6ac84bcb 0603-6241 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 19981224 ANDA ANDA040254 Qualitest Pharmaceuticals TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 0603-6330_b1b03332-d61a-4258-806e-8b565faac075 0603-6330 HUMAN PRESCRIPTION DRUG Valganciclovir Valganciclovir TABLET, FILM COATED ORAL 20141104 ANDA ANDA200790 Qualitest Pharmaceuticals VALACYCLOVIR HYDROCHLORIDE 450 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0603-6345_6f8c6721-4825-49a9-88a6-1af65115eade 0603-6345 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130320 ANDA ANDA201662 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0603-6346_6f8c6721-4825-49a9-88a6-1af65115eade 0603-6346 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130320 ANDA ANDA201662 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0603-6347_6f8c6721-4825-49a9-88a6-1af65115eade 0603-6347 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130320 ANDA ANDA201662 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0603-6348_6f8c6721-4825-49a9-88a6-1af65115eade 0603-6348 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130320 ANDA ANDA201662 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0603-6349_6f8c6721-4825-49a9-88a6-1af65115eade 0603-6349 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130320 ANDA ANDA201662 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0603-6468_c883df80-cd6d-446a-a2c6-00541dc14a29 0603-6468 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Qualitest Pharmaceuticals ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0603-6469_c883df80-cd6d-446a-a2c6-00541dc14a29 0603-6469 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Qualitest Pharmaceuticals ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0603-7038_b8105d62-0c19-44e8-a477-13776fb09dfa 0603-7038 HUMAN PRESCRIPTION DRUG Acetic Acid Acetic Acid SOLUTION AURICULAR (OTIC) 20050224 ANDA ANDA040607 Qualitest Pharmaceuticals ACETIC ACID .02 mL/mL 0603-7039_cd7bffeb-5349-44c2-b7fc-080f26f5ce58 0603-7039 HUMAN PRESCRIPTION DRUG Hydrocortisone and Acetic Acid hydrocortisone and acetic acid SOLUTION AURICULAR (OTIC) 20060206 ANDA ANDA040609 Qualitest Pharmaceuticals ACETIC ACID; HYDROCORTISONE .02; .01 mL/mL; mL/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0603-7521_92769031-e10f-460b-895f-5bd760f9f99a 0603-7521 HUMAN PRESCRIPTION DRUG Cyclafem 1/35 norethindrone and ethinyl estradiol KIT 20101112 ANDA ANDA076337 Qualitest Pharmaceuticals 0603-7525_d80ff169-0f8b-4166-bcde-52b6d9d8442e 0603-7525 HUMAN PRESCRIPTION DRUG Cyclafem 7/7/7 norethindrone and ethinyl estradiol KIT 20101116 ANDA ANDA076338 Qualitest Pharmaceuticals 0603-7540_34315ebd-1ecd-419e-95fc-de709376110b 0603-7540 HUMAN PRESCRIPTION DRUG Emoquette desogestrel and ethinyl estradiol KIT 20110225 ANDA ANDA076675 Qualitest Pharmaceuticals 0603-7606_661bda0d-efdf-4896-a97c-d172e31d329c 0603-7606 HUMAN PRESCRIPTION DRUG Gildess 1.5/30 norethindrone acetate and ethinyl estradiol TABLET, FILM COATED ORAL 20120724 ANDA ANDA077075 Qualitest Pharmaceuticals ETHINYL ESTRADIOL; NORETHINDRONE ACETATE .03; 1.5 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0603-7607_74bd4307-b407-4e93-a0df-ab6f587a35a2 0603-7607 HUMAN PRESCRIPTION DRUG Gildess 1/20 norethindrone acetate and ethinyl estradiol TABLET, FILM COATED ORAL 20120724 ANDA ANDA077077 Qualitest Pharmaceuticals ETHINYL ESTRADIOL; NORETHINDRONE ACETATE .02; 1 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 0603-7608_ee9eaab7-70d8-4a3c-9084-a178482e45e9 0603-7608 HUMAN PRESCRIPTION DRUG GILDESS FE 1.5/30 norethindrone acetate, ethinyl estradiol and ferrous fumarate KIT 20050428 ANDA ANDA077075 Qualitest Pharmaceuticals 0603-7609_f1a144a3-05b6-4ce7-8894-ab642438613d 0603-7609 HUMAN PRESCRIPTION DRUG GILDESS FE 1/20 norethindrone acetate, ethinyl estradiol and ferrous fumarate KIT 20050520 ANDA ANDA077077 Qualitest Pharmaceuticals 0603-7610_00a301c9-4e03-4a49-9b0d-a433c8250384 0603-7610 HUMAN PRESCRIPTION DRUG Gildess 24 Fe norethindrone acetate and ethinyl estradiol and ferrous fumarate KIT 20141201 ANDA ANDA090293 Qualitest Pharmaceuticals 0603-7625_0e744454-071d-40df-a13d-4e3ac17a881d 0603-7625 HUMAN PRESCRIPTION DRUG Myzilra Levonorgestrel and Ethinyl Estradiol KIT 20120112 ANDA ANDA077502 Qualitest Pharmaceuticals 0603-7634_cd9b9e85-9d89-4e52-a7fe-dd288d13f7b2 0603-7634 HUMAN PRESCRIPTION DRUG Orsythia levonorgestrel and ethinyl estradiol KIT ORAL 20110511 ANDA ANDA077099 Qualitest Pharmaceuticals 0603-7642_fb15d7dc-23f6-4568-a3b3-6af1cf5e8a56 0603-7642 HUMAN PRESCRIPTION DRUG Previfem norgestimate and ethinyl estradiol KIT 20040109 ANDA ANDA076334 Qualitest Pharmaceuticals 0603-7663_3e5194dd-9f02-493c-acd5-bd0fde061511 0603-7663 HUMAN PRESCRIPTION DRUG Tri Previfem norgestimate and ethinyl estradiol KIT 20040326 ANDA ANDA076335 Qualitest Pharmaceuticals 0603-7781_af637cd0-a1ca-46a7-bf50-02b060d34ce4 0603-7781 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone CREAM TOPICAL 20040312 ANDA ANDA040503 Qualitest Pharmaceuticals HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0603-7785_9e81b762-0f54-4d71-8fca-3c86fa1a7db5 0603-7785 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone LOTION TOPICAL 20030730 ANDA ANDA040417 Qualitest Pharmaceuticals HYDROCORTISONE 25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0603-7805_f6f3a3d8-ce56-4a43-82ff-e3749484818b 0603-7805 HUMAN OTC DRUG Miconazole Nitrate miconazole nitrate CREAM TOPICAL 20030901 OTC MONOGRAPH FINAL part333C Qualitest Pharmaceuticals MICONAZOLE NITRATE 20 mg/g 0603-7818_eb41685e-eaf2-482c-a2e2-8f4cabea04df 0603-7818 HUMAN PRESCRIPTION DRUG Nystatin nystatin CREAM TOPICAL 20060531 ANDA ANDA065315 Qualitest Pharmaceuticals NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 0603-7831_10b3344b-1dc2-4bfe-9da6-ab1d29076e05 0603-7831 HUMAN PRESCRIPTION DRUG Testosterone Testosterone GEL, METERED TOPICAL 20140825 NDA AUTHORIZED GENERIC NDA021463 Qualitest Pharmaceuticals TESTOSTERONE 10 mg/.5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0603-7861_6d917a98-cb55-4a55-9892-78feb66c264b 0603-7861 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide CREAM TOPICAL 20060609 ANDA ANDA040671 Qualitest Pharmaceuticals TRIAMCINOLONE ACETONIDE .25 mg/g 0603-7862_6d917a98-cb55-4a55-9892-78feb66c264b 0603-7862 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide CREAM TOPICAL 20060609 ANDA ANDA040671 Qualitest Pharmaceuticals TRIAMCINOLONE ACETONIDE 1 mg/g 0603-7864_2f4bef20-72fa-4bd2-8c9c-d1aa8d9a74a3 0603-7864 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide LOTION TOPICAL 20061213 ANDA ANDA040672 Qualitest Pharmaceuticals TRIAMCINOLONE ACETONIDE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0603-9013_b8fce018-4408-49bd-a2b1-68a7fed74854 0603-9013 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine Acetaminophen and Codeine Phosphate SOLUTION ORAL 20111110 ANDA ANDA091238 Qualitest Pharmaceuticals ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 0603-9063_3cde6bda-0fc0-422f-bb0d-14146cbcd201 0603-9063 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride cetirizine hydrochloride SYRUP ORAL 20090925 ANDA ANDA078496 Qualitest Pharmaceuticals CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0603-9171_aaa3946a-2169-474f-b132-858c04d41097 0603-9171 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin SUSPENSION ORAL 20101008 ANDA ANDA065438 Qualitest Pharmaceuticals GRISEOFULVIN 125 mg/5mL Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 0603-9388_a8095bb4-78bf-41fe-bd04-95b02e49e3f5 0603-9388 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20090526 ANDA ANDA079010 Qualitest Pharmaceuticals PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0603-9418_6ae4d1ff-af4a-486d-bca3-011f395b9783 0603-9418 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SOLUTION ORAL 20100701 ANDA ANDA078890 Qualitest Pharmaceuticals RANITIDINE HYDROCHLORIDE 75 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0603-9424_046bb27e-06c7-489c-b759-6d2f95d4e5a8 0603-9424 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20101203 ANDA ANDA079158 Qualitest Pharmaceuticals RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] 0615-0170_e4d076e6-157c-4596-b575-ae4a6b9bda4e 0615-0170 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 NCS HealthCare of KY, Inc dba Vangard Labs SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0615-0326_1e900e41-8b74-41fe-b99e-88dd030c11b7 0615-0326 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19870218 ANDA ANDA071293 NCS HealthCare of KY, Inc dba Vangard Labs AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 0615-0327_a539d618-2eae-41d6-8e00-b48d001c00fa 0615-0327 HUMAN PRESCRIPTION DRUG Dicyclomine dicyclomine hydrochloride CAPSULE ORAL 19970228 ANDA ANDA040204 NCS HealthCare of KY, Inc dba Vangard Labs DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0615-0331_45db7593-81bf-4a29-ba13-c86cd4fb3d8f 0615-0331 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA087479 NCS HealthCare of KY, Inc dba Vangard Labs HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0615-0332_b075d1a9-8d2b-4a0b-96a4-95841830e2bf 0615-0332 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19811214 ANDA ANDA086183 NCS HealthCare of KY, Inc dba Vangard Labs HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0615-0362_966727a6-6e9f-4988-9e3a-5bd9ce086310 0615-0362 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 20121012 ANDA ANDA072741 NCS HealthCare of KY, Inc dba Vangard Labs LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 0615-0378_9328e83b-c249-40bd-82fb-376b8ccd9739 0615-0378 HUMAN OTC DRUG Docusate Calcium Docusate Calcium CAPSULE ORAL 20111201 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs DOCUSATE CALCIUM 240 mg/1 0615-0446_7c5111c8-7a8c-4e90-b257-4379b7d469de 0615-0446 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831130 NDA NDA018413 NCS HealthCare of KY, Inc dba Vangard Labs FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0615-0516_6e9ef933-24b0-4b08-bd4d-a25df09c7c38 0615-0516 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19821005 ANDA ANDA087836 NCS HealthCare of KY, Inc dba Vangard Labs HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 0615-0518_794757db-646d-414a-9faa-d444e7116780 0615-0518 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 NCS HealthCare of KY, Inc dba Vangard Labs DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0615-0522_5c38d339-bd06-4c99-b177-c7addf73557f 0615-0522 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20090930 OTC MONOGRAPH FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ASPIRIN 325 mg/1 0615-0531_6e9ef933-24b0-4b08-bd4d-a25df09c7c38 0615-0531 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19800227 ANDA ANDA086961 NCS HealthCare of KY, Inc dba Vangard Labs HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 0615-0532_6e9ef933-24b0-4b08-bd4d-a25df09c7c38 0615-0532 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19800227 ANDA ANDA086962 NCS HealthCare of KY, Inc dba Vangard Labs HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 0615-0536_255e03dc-b1a1-4660-8c07-ede81b9f1e5e 0615-0536 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 NCS HealthCare of KY, Inc dba Vangard Labs PREDNISONE 5 mg/1 0615-0547_f002a62a-bf93-4ec8-b88a-91683b3e19ce 0615-0547 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 NCS HealthCare of KY, Inc dba Vangard Labs DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0615-0564_1e23707d-f41d-486e-b4b3-c0d3dec32a55 0615-0564 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ASPIRIN 325 mg/1 0615-0585_3154b168-1ad8-4dbf-a615-63458f17cc4c 0615-0585 HUMAN OTC DRUG Docusate Sodium DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100423 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs DOCUSATE SODIUM 100 mg/1 0615-0586_fbf5de0e-45c0-4ba9-8557-70d82de4e3ae 0615-0586 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs DOCUSATE SODIUM 250 mg/1 0615-0591_e3e632a9-1991-45c7-82c4-dba0a1499810 0615-0591 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20100804 OTC MONOGRAPH FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ACETAMINOPHEN 325 mg/1 0615-0598_8f2fa151-2171-45dc-bd2a-6e7ae4248156 0615-0598 HUMAN OTC DRUG Bisacodyl Bisacodyl Enteric Coated TABLET, COATED ORAL 19930902 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs BISACODYL 5 mg/1 0615-0675_8a4dc266-81f7-46aa-8c90-24cece8f55af 0615-0675 HUMAN PRESCRIPTION DRUG Trihexyphenidyl hydrochloride Trihexyphenidyl hydrochloride TABLET ORAL 19980206 ANDA ANDA040184 NCS HealthCare of KY, Inc dba Vangard Labs TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 0615-0676_8a4dc266-81f7-46aa-8c90-24cece8f55af 0615-0676 HUMAN PRESCRIPTION DRUG Trihexyphenidyl hydrochloride Trihexyphenidyl hydrochloride TABLET ORAL 19980206 ANDA ANDA040184 NCS HealthCare of KY, Inc dba Vangard Labs TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 0615-0828_ac604638-a8d2-4925-b940-8387dc27d488 0615-0828 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 NCS HealthCare of KY, Inc dba Vangard Labs AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0615-0829_ac604638-a8d2-4925-b940-8387dc27d488 0615-0829 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 NCS HealthCare of KY, Inc dba Vangard Labs AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0615-0830_ac604638-a8d2-4925-b940-8387dc27d488 0615-0830 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 NCS HealthCare of KY, Inc dba Vangard Labs AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0615-1308_c8974e25-2da4-4113-b7ef-4707587488c3 0615-1308 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin CAPSULE ORAL 19970709 ANDA ANDA074967 NCS HealthCare of KY, Inc dba Vangard Labs NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 0615-1311_332d9499-f831-4d29-9270-43370119d957 0615-1311 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19801126 NDA NDA017812 NCS HealthCare of KY, Inc dba Vangard Labs LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 0615-1318_d281058f-5ff7-40d2-a872-03dc73896ec8 0615-1318 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium CAPSULE ORAL 20080602 ANDA ANDA077419 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 750 mg/1 0615-1324_c5453821-e9e9-4ae2-a3e1-9d1b51b420b5 0615-1324 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0615-1325_bd2301b2-796e-4c1b-a18d-dfd03bc22fef 0615-1325 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid CAPSULE ORAL 19911029 ANDA ANDA073229 NCS HealthCare of KY, Inc dba Vangard Labs VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0615-1333_194a19cf-d20f-43f0-b279-e23b8e23f540 0615-1333 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide triamterene and hydrochlorothiazide CAPSULE ORAL 20110504 ANDA ANDA074701 NCS HealthCare of KY, Inc dba Vangard Labs HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 0615-1337_07474745-48ff-4c2d-8602-1ea104cf76cb 0615-1337 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin CAPSULE ORAL 19980330 ANDA ANDA074823 NCS HealthCare of KY, Inc dba Vangard Labs TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0615-1338_07474745-48ff-4c2d-8602-1ea104cf76cb 0615-1338 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin CAPSULE ORAL 19980330 ANDA ANDA074823 NCS HealthCare of KY, Inc dba Vangard Labs TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0615-1339_07474745-48ff-4c2d-8602-1ea104cf76cb 0615-1339 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin CAPSULE ORAL 19980330 ANDA ANDA074823 NCS HealthCare of KY, Inc dba Vangard Labs TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0615-1341_c5453821-e9e9-4ae2-a3e1-9d1b51b420b5 0615-1341 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0615-1342_c5453821-e9e9-4ae2-a3e1-9d1b51b420b5 0615-1342 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0615-1343_963929bb-80d0-4b86-a6e1-555f6985af57 0615-1343 HUMAN PRESCRIPTION DRUG Phenytoin Sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20091120 ANDA ANDA040298 NCS HealthCare of KY, Inc dba Vangard Labs PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-1349_af8036bf-eecc-4e91-a66c-e6bf5dbb8f79 0615-1349 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20101114 ANDA ANDA081297 NCS HealthCare of KY, Inc dba Vangard Labs BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 0615-1354_06184a4a-2e68-4ec7-93b0-637d75ea1d1d 0615-1354 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride CAPSULE ORAL 19971022 ANDA ANDA074655 NCS HealthCare of KY, Inc dba Vangard Labs RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0615-1355_c5453821-e9e9-4ae2-a3e1-9d1b51b420b5 0615-1355 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0615-1357_22cc492e-e9ec-4d88-baf7-e6f81fa597d5 0615-1357 HUMAN PRESCRIPTION DRUG fluoxetine fluoxetine hydrochloride CAPSULE ORAL 20100429 ANDA ANDA075245 NCS HealthCare of KY, Inc dba Vangard Labs FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-1358_5a46a312-7e31-4703-b951-537762dbf934 0615-1358 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 19961227 NDA AUTHORIZED GENERIC NDA020504 NCS HealthCare of KY, Inc dba Vangard Labs HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0615-1359_dabee1e0-fccb-4eee-93a5-d7bc058ac10d 0615-1359 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20030128 ANDA ANDA075757 NCS HealthCare of KY, Inc dba Vangard Labs OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0615-1374_d56397c5-a066-4e2d-bc5a-11b61057db4c 0615-1374 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 19871231 NDA NDA019594 NCS HealthCare of KY, Inc dba Vangard Labs URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 0615-1376_d8df25f8-fbd2-41e4-b5b2-a4b10ddd67b2 0615-1376 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20030912 ANDA ANDA075350 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-1377_d8df25f8-fbd2-41e4-b5b2-a4b10ddd67b2 0615-1377 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20030912 ANDA ANDA075350 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-1378_d8df25f8-fbd2-41e4-b5b2-a4b10ddd67b2 0615-1378 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20030912 ANDA ANDA075350 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-1379_b15b9eb1-288c-49b6-bc25-520791b5f6fb 0615-1379 HUMAN PRESCRIPTION DRUG Zonisamide zonisamide CAPSULE ORAL 20121022 ANDA ANDA077637 NCS HealthCare of KY, Inc dba Vangard Labs ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-1384_58fe7d20-4803-4761-9098-d859806b0564 0615-1384 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080520 ANDA ANDA076287 NCS HealthCare of KY, Inc dba Vangard Labs FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-1387_8e35dc0e-bf0e-49d8-b5a7-7b76d5829795 0615-1387 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20020129 ANDA ANDA075049 NCS HealthCare of KY, Inc dba Vangard Labs FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-1393_8fcacd6a-d1c2-4d63-8717-b6bd6ef42f55 0615-1393 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium CAPSULE ORAL 20090123 ANDA ANDA078979 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0615-1397_d9910f83-8c88-4269-a518-60d97c2d4ff2 0615-1397 HUMAN PRESCRIPTION DRUG amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 NCS HealthCare of KY, Inc dba Vangard Labs AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0615-1398_d9910f83-8c88-4269-a518-60d97c2d4ff2 0615-1398 HUMAN PRESCRIPTION DRUG amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 NCS HealthCare of KY, Inc dba Vangard Labs AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0615-1399_d9910f83-8c88-4269-a518-60d97c2d4ff2 0615-1399 HUMAN PRESCRIPTION DRUG amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 NCS HealthCare of KY, Inc dba Vangard Labs AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0615-1501_6209ef07-f7bc-49f1-a034-d6900275db01 0615-1501 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19880812 ANDA ANDA089804 NCS HealthCare of KY, Inc dba Vangard Labs FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0615-1504_06ca0dcb-5a5c-4104-b38f-b964fbcca08c 0615-1504 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110718 ANDA ANDA074201 NCS HealthCare of KY, Inc dba Vangard Labs NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0615-1511_7a721f27-95ce-4e0b-9a93-8cc3d8f6e188 0615-1511 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE AcetaZOLAMIDE TABLET ORAL 19970528 ANDA ANDA040195 NCS HealthCare of KY, Inc dba Vangard Labs ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 0615-1516_fb4f04ea-4c2b-4f25-aa59-22ff246ee2a3 0615-1516 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 NCS HealthCare of KY, Inc dba Vangard Labs DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0615-1525_de28671d-80b7-4744-b87f-97b82a50b25f 0615-1525 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20070320 ANDA ANDA040786 NCS HealthCare of KY, Inc dba Vangard Labs HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0615-1526_de28671d-80b7-4744-b87f-97b82a50b25f 0615-1526 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20070320 ANDA ANDA040786 NCS HealthCare of KY, Inc dba Vangard Labs HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0615-1527_de28671d-80b7-4744-b87f-97b82a50b25f 0615-1527 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20070320 ANDA ANDA040786 NCS HealthCare of KY, Inc dba Vangard Labs HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0615-1535_c811c81f-84d9-4d55-bbd4-2b30a6e5a32d 0615-1535 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20010820 ANDA ANDA040424 NCS HealthCare of KY, Inc dba Vangard Labs SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0615-1536_4a02f757-be72-4d37-b1a1-a6d8fd716fd7 0615-1536 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20100108 ANDA ANDA087056 NCS HealthCare of KY, Inc dba Vangard Labs CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 0615-1539_909a1473-2a2f-4ee1-94aa-a4b62a7fafdc 0615-1539 HUMAN PRESCRIPTION DRUG Promethazine Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 NCS HealthCare of KY, Inc dba Vangard Labs PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0615-1542_255e03dc-b1a1-4660-8c07-ede81b9f1e5e 0615-1542 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA087342 NCS HealthCare of KY, Inc dba Vangard Labs PREDNISONE 20 mg/1 0615-1546_4d95826c-dfb7-4752-86ea-54f4b83e04aa 0615-1546 HUMAN PRESCRIPTION DRUG Chlorpromazine Chlorpromazine Hydrochloride TABLET, FILM COATED ORAL 19730103 ANDA ANDA080439 NCS HealthCare of KY, Inc dba Vangard Labs CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0615-1547_4d95826c-dfb7-4752-86ea-54f4b83e04aa 0615-1547 HUMAN PRESCRIPTION DRUG Chlorpromazine Chlorpromazine Hydrochloride TABLET, FILM COATED ORAL 19730103 ANDA ANDA080439 NCS HealthCare of KY, Inc dba Vangard Labs CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0615-1548_4d95826c-dfb7-4752-86ea-54f4b83e04aa 0615-1548 HUMAN PRESCRIPTION DRUG Chlorpromazine Chlorpromazine Hydrochloride TABLET, FILM COATED ORAL 19730103 ANDA ANDA080439 NCS HealthCare of KY, Inc dba Vangard Labs CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0615-1553_7702fa9a-8753-4e45-9b6d-962291f17599 0615-1553 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087127 NCS HealthCare of KY, Inc dba Vangard Labs MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 0615-1554_7702fa9a-8753-4e45-9b6d-962291f17599 0615-1554 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087128 NCS HealthCare of KY, Inc dba Vangard Labs MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 0615-1556_b1041447-db42-4ca8-b2e6-287caf24c7f2 0615-1556 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 NCS HealthCare of KY, Inc dba Vangard Labs GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0615-1560_4b8ba147-c2a9-42df-b4f5-d76295409703 0615-1560 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086066 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0615-1561_73dec564-4a70-41c2-8327-fea81b58e23e 0615-1561 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 NCS HealthCare of KY, Inc dba Vangard Labs HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0615-1562_73dec564-4a70-41c2-8327-fea81b58e23e 0615-1562 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 NCS HealthCare of KY, Inc dba Vangard Labs HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0615-1569_7c5111c8-7a8c-4e90-b257-4379b7d469de 0615-1569 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831130 NDA NDA018413 NCS HealthCare of KY, Inc dba Vangard Labs FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0615-1571_60c97f84-e500-4de9-9e26-e5b2b9bf14e5 0615-1571 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 NCS HealthCare of KY, Inc dba Vangard Labs FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0615-1573_f26e686a-aa0a-4e50-a492-d25a3fe8c201 0615-1573 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20110123 ANDA ANDA087716 NCS HealthCare of KY, Inc dba Vangard Labs DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0615-1575_4b8ba147-c2a9-42df-b4f5-d76295409703 0615-1575 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19830426 ANDA ANDA088088 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0615-1576_d320471c-96fe-4559-83cd-333a6b2f3315 0615-1576 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19841220 ANDA ANDA070035 NCS HealthCare of KY, Inc dba Vangard Labs METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0615-1577_d320471c-96fe-4559-83cd-333a6b2f3315 0615-1577 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19841220 ANDA ANDA070035 NCS HealthCare of KY, Inc dba Vangard Labs METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0615-1590_9864e22b-201f-455d-9361-786fad14bb2f 0615-1590 HUMAN PRESCRIPTION DRUG Theophylline Extended Release Theophylline, anhydrous TABLET, EXTENDED RELEASE ORAL 19900430 ANDA ANDA089763 NCS HealthCare of KY, Inc dba Vangard Labs THEOPHYLLINE 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0615-1592_1a989f28-0766-4bc9-ad9b-c0beaefa7fe8 0615-1592 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 19861024 NDA AUTHORIZED GENERIC NDA018659 NCS HealthCare of KY, Inc dba Vangard Labs ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 0615-1593_1a989f28-0766-4bc9-ad9b-c0beaefa7fe8 0615-1593 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 19861024 NDA AUTHORIZED GENERIC NDA018659 NCS HealthCare of KY, Inc dba Vangard Labs ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 0615-2302_e3144ea7-4181-4efd-b95b-6fe3c6440cbf 0615-2302 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20071022 ANDA ANDA075576 NCS HealthCare of KY, Inc dba Vangard Labs OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0615-2303_74b12ef7-cce8-4241-95ac-98775b3f8b3e 0615-2303 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20080226 ANDA ANDA077728 NCS HealthCare of KY, Inc dba Vangard Labs CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0615-2304_332d9499-f831-4d29-9270-43370119d957 0615-2304 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19870128 NDA NDA017812 NCS HealthCare of KY, Inc dba Vangard Labs LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] 0615-2305_e3144ea7-4181-4efd-b95b-6fe3c6440cbf 0615-2305 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20071022 ANDA ANDA075576 NCS HealthCare of KY, Inc dba Vangard Labs OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0615-2503_282f24d5-31de-4b2e-8262-361119501b12 0615-2503 HUMAN PRESCRIPTION DRUG Theophylline Extended Release Theophylline, anhydrous TABLET, EXTENDED RELEASE ORAL 19900430 ANDA ANDA089808 NCS HealthCare of KY, Inc dba Vangard Labs THEOPHYLLINE 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0615-2513_255e03dc-b1a1-4660-8c07-ede81b9f1e5e 0615-2513 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087801 NCS HealthCare of KY, Inc dba Vangard Labs PREDNISONE 2.5 mg/1 0615-2519_d7adb695-e703-4ec9-8517-b759d3bd3cf0 0615-2519 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20101213 ANDA ANDA040185 NCS HealthCare of KY, Inc dba Vangard Labs PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0615-2520_d7adb695-e703-4ec9-8517-b759d3bd3cf0 0615-2520 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20101213 ANDA ANDA040185 NCS HealthCare of KY, Inc dba Vangard Labs PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0615-2521_8757a56a-c01b-4d1d-93e1-3e18ec381daf 0615-2521 HUMAN PRESCRIPTION DRUG Primidone primidone TABLET ORAL 20060701 ANDA ANDA040667 NCS HealthCare of KY, Inc dba Vangard Labs PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-2525_3b4b9e14-7d9d-4bb1-a302-421eb916640a 0615-2525 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 NCS HealthCare of KY, Inc dba Vangard Labs IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0615-2526_3b4b9e14-7d9d-4bb1-a302-421eb916640a 0615-2526 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 NCS HealthCare of KY, Inc dba Vangard Labs IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0615-2528_3b4b9e14-7d9d-4bb1-a302-421eb916640a 0615-2528 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 NCS HealthCare of KY, Inc dba Vangard Labs IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0615-2536_fa8e7ef1-a49a-4ab6-a158-11ef3dc1e583 0615-2536 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19851017 ANDA ANDA070581 NCS HealthCare of KY, Inc dba Vangard Labs METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0615-2542_7b04fc45-e29c-44c9-ae97-da429be95b84 0615-2542 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110504 OTC MONOGRAPH NOT FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ACETAMINOPHEN 500 mg/1 0615-2547_727070e9-1e14-4aab-b015-75abd66cd910 0615-2547 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20100228 ANDA ANDA089058 NCS HealthCare of KY, Inc dba Vangard Labs BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0615-2548_727070e9-1e14-4aab-b015-75abd66cd910 0615-2548 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20100228 ANDA ANDA089059 NCS HealthCare of KY, Inc dba Vangard Labs BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0615-2549_727070e9-1e14-4aab-b015-75abd66cd910 0615-2549 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20100228 ANDA ANDA089060 NCS HealthCare of KY, Inc dba Vangard Labs BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0615-2557_048ea5dc-4eeb-4bce-8047-a0eade2ae885 0615-2557 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20030929 ANDA ANDA040533 NCS HealthCare of KY, Inc dba Vangard Labs BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0615-2558_048ea5dc-4eeb-4bce-8047-a0eade2ae885 0615-2558 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20030929 ANDA ANDA040533 NCS HealthCare of KY, Inc dba Vangard Labs BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0615-2561_631fbd02-ac53-4b98-bda2-827ee4438c0d 0615-2561 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 NCS HealthCare of KY, Inc dba Vangard Labs PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-2562_631fbd02-ac53-4b98-bda2-827ee4438c0d 0615-2562 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 NCS HealthCare of KY, Inc dba Vangard Labs PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-2563_631fbd02-ac53-4b98-bda2-827ee4438c0d 0615-2563 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 NCS HealthCare of KY, Inc dba Vangard Labs PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-2572_72e958d1-cbc6-4c81-9ae0-7490e1908c0a 0615-2572 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19861216 ANDA ANDA070974 NCS HealthCare of KY, Inc dba Vangard Labs CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0615-2573_72e958d1-cbc6-4c81-9ae0-7490e1908c0a 0615-2573 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19861216 ANDA ANDA070975 NCS HealthCare of KY, Inc dba Vangard Labs CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0615-2574_72e958d1-cbc6-4c81-9ae0-7490e1908c0a 0615-2574 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19861216 ANDA ANDA070976 NCS HealthCare of KY, Inc dba Vangard Labs CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0615-2578_0ff7d0a2-f27f-4383-8736-bf6e9934c993 0615-2578 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110120 ANDA ANDA071523 NCS HealthCare of KY, Inc dba Vangard Labs TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 0615-2579_0ff7d0a2-f27f-4383-8736-bf6e9934c993 0615-2579 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110120 ANDA ANDA071524 NCS HealthCare of KY, Inc dba Vangard Labs TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 0615-2594_eff4b566-4acb-4f8b-8697-cdb78d7790f0 0615-2594 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20110113 ANDA ANDA070278 NCS HealthCare of KY, Inc dba Vangard Labs HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] 0615-2595_eff4b566-4acb-4f8b-8697-cdb78d7790f0 0615-2595 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20110113 ANDA ANDA070278 NCS HealthCare of KY, Inc dba Vangard Labs HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] 0615-2596_eff4b566-4acb-4f8b-8697-cdb78d7790f0 0615-2596 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20110113 ANDA ANDA070278 NCS HealthCare of KY, Inc dba Vangard Labs HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] 0615-2597_eff4b566-4acb-4f8b-8697-cdb78d7790f0 0615-2597 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20110113 ANDA ANDA070278 NCS HealthCare of KY, Inc dba Vangard Labs HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 0615-2598_bbaf5f11-91e6-45ce-a15f-b26d498e456d 0615-2598 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19880311 ANDA ANDA071210 NCS HealthCare of KY, Inc dba Vangard Labs HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] 0615-3505_067e666f-2b47-4b1d-8852-3e2737ae42ff 0615-3505 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19900930 ANDA ANDA070541 NCS HealthCare of KY, Inc dba Vangard Labs CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0615-3508_1eb5b95f-feda-47c6-aabe-b3376f9cf84f 0615-3508 HUMAN OTC DRUG Aspirin Chewable Aspirin Chewable TABLET ORAL 20071212 OTC MONOGRAPH NOT FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ASPIRIN 81 mg/1 0615-3512_a2906a86-446f-473d-b8b8-f720b6c5c661 0615-3512 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20121030 ANDA ANDA075079 NCS HealthCare of KY, Inc dba Vangard Labs OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0615-3520_23ae4858-2793-41f9-b621-1f626962e11c 0615-3520 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 NCS HealthCare of KY, Inc dba Vangard Labs CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0615-3527_bcd9b0c4-449c-4ccd-ab35-a9418e30625b 0615-3527 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20091216 ANDA ANDA071333 NCS HealthCare of KY, Inc dba Vangard Labs IBUPROFEN 200 mg/1 0615-3532_e7ac49a8-be11-4034-8fea-a3832e9cc390 0615-3532 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20130218 ANDA ANDA073457 NCS HealthCare of KY, Inc dba Vangard Labs ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-3533_2c9479d8-ddb7-4d42-93bb-cdc7be1ba8b1 0615-3533 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20120430 ANDA ANDA073457 NCS HealthCare of KY, Inc dba Vangard Labs ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-3537_ccd002ff-0bba-495f-96c2-a97f13689bb2 0615-3537 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 19930901 ANDA ANDA074260 NCS HealthCare of KY, Inc dba Vangard Labs CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0615-3541_6e06a800-89d5-44ee-ba79-413994c97f1b 0615-3541 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100715 ANDA ANDA072234 NCS HealthCare of KY, Inc dba Vangard Labs BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 0615-3542_6e06a800-89d5-44ee-ba79-413994c97f1b 0615-3542 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100715 ANDA ANDA072235 NCS HealthCare of KY, Inc dba Vangard Labs BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 0615-3544_9d9efe8b-9891-41dc-bc3c-5951f5c058ed 0615-3544 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 ANDA ANDA074052 NCS HealthCare of KY, Inc dba Vangard Labs ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-3548_65056a10-2b8a-422d-9c01-daf103203ed2 0615-3548 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 20121204 ANDA ANDA072838 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0615-3549_65056a10-2b8a-422d-9c01-daf103203ed2 0615-3549 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 20121204 ANDA ANDA072838 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0615-3550_65056a10-2b8a-422d-9c01-daf103203ed2 0615-3550 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 20121204 ANDA ANDA072838 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0615-3551_65056a10-2b8a-422d-9c01-daf103203ed2 0615-3551 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 20121204 ANDA ANDA072838 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0615-3552_e6f2fa71-081a-46a4-9801-b4ed99dc7e21 0615-3552 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-3553_e6f2fa71-081a-46a4-9801-b4ed99dc7e21 0615-3553 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-3559_60066328-8964-4c3a-9b4f-236d35d0ffb2 0615-3559 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19931124 ANDA ANDA074256 NCS HealthCare of KY, Inc dba Vangard Labs GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0615-3561_ccd002ff-0bba-495f-96c2-a97f13689bb2 0615-3561 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 19930901 ANDA ANDA074260 NCS HealthCare of KY, Inc dba Vangard Labs CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0615-3562_06ca0dcb-5a5c-4104-b38f-b964fbcca08c 0615-3562 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110718 ANDA ANDA074201 NCS HealthCare of KY, Inc dba Vangard Labs NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0615-3563_5a73a2a0-8ccf-4c23-8bc8-d7a2903ab7d5 0615-3563 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20101213 ANDA ANDA074201 NCS HealthCare of KY, Inc dba Vangard Labs NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0615-3568_8749bde6-9a51-4e60-93b8-d2e893e112b4 0615-3568 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20100805 OTC MONOGRAPH FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ASPIRIN 81 mg/1 0615-3570_32213700-b200-4a92-bb79-17291ff6ed18 0615-3570 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19880808 ANDA ANDA072423 NCS HealthCare of KY, Inc dba Vangard Labs MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0615-3574_6209ef07-f7bc-49f1-a034-d6900275db01 0615-3574 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19880812 ANDA ANDA089804 NCS HealthCare of KY, Inc dba Vangard Labs FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0615-3583_e1b364bf-91ef-4712-8b5e-a6dd86033d68 0615-3583 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19920430 ANDA ANDA073281 NCS HealthCare of KY, Inc dba Vangard Labs HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0615-3584_1a2048f4-f9ed-49e6-ab7d-c968120ff4e1 0615-3584 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 19881208 ANDA ANDA089683 NCS HealthCare of KY, Inc dba Vangard Labs PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0615-3585_1a2048f4-f9ed-49e6-ab7d-c968120ff4e1 0615-3585 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 19881208 ANDA ANDA089683 NCS HealthCare of KY, Inc dba Vangard Labs PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0615-3588_a6d634a2-1c0f-447e-b3fd-6b210acab42f 0615-3588 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120223 ANDA ANDA074330 NCS HealthCare of KY, Inc dba Vangard Labs VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0615-3589_a6d634a2-1c0f-447e-b3fd-6b210acab42f 0615-3589 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120223 ANDA ANDA073568 NCS HealthCare of KY, Inc dba Vangard Labs VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0615-3593_255e03dc-b1a1-4660-8c07-ede81b9f1e5e 0615-3593 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA084122 NCS HealthCare of KY, Inc dba Vangard Labs PREDNISONE 10 mg/1 0615-3595_792a3d71-8cb9-4c4c-84e8-9e1376787005 0615-3595 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19940510 ANDA ANDA074226 NCS HealthCare of KY, Inc dba Vangard Labs GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0615-3596_792a3d71-8cb9-4c4c-84e8-9e1376787005 0615-3596 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19940510 ANDA ANDA074226 NCS HealthCare of KY, Inc dba Vangard Labs GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0615-3599_f4616553-a74b-44cc-89f1-7772bb2c7bac 0615-3599 HUMAN PRESCRIPTION DRUG Klor Con M potassium chloride TABLET, EXTENDED RELEASE ORAL 19981120 ANDA ANDA074726 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0615-4504_ccd002ff-0bba-495f-96c2-a97f13689bb2 0615-4504 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 19930901 ANDA ANDA074260 NCS HealthCare of KY, Inc dba Vangard Labs CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0615-4506_4d48eca9-541a-43b1-9345-23eeb66ca022 0615-4506 HUMAN PRESCRIPTION DRUG diclofenac sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 NCS HealthCare of KY, Inc dba Vangard Labs DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0615-4507_4d48eca9-541a-43b1-9345-23eeb66ca022 0615-4507 HUMAN PRESCRIPTION DRUG diclofenac sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 NCS HealthCare of KY, Inc dba Vangard Labs DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0615-4509_e12c79fb-5bd5-4310-81c2-2f4f9af0e160 0615-4509 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 NCS HealthCare of KY, Inc dba Vangard Labs GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0615-4510_765bce7c-41b2-4656-bdb2-74da80267506 0615-4510 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20121004 OTC MONOGRAPH FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ACETAMINOPHEN 500 mg/1 0615-4511_1a2048f4-f9ed-49e6-ab7d-c968120ff4e1 0615-4511 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 19881208 ANDA ANDA089683 NCS HealthCare of KY, Inc dba Vangard Labs PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0615-4513_40dc2a98-5890-49c8-8299-be9225d8fc8b 0615-4513 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20091106 ANDA ANDA075165 NCS HealthCare of KY, Inc dba Vangard Labs RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0615-4514_40dc2a98-5890-49c8-8299-be9225d8fc8b 0615-4514 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20091106 ANDA ANDA075165 NCS HealthCare of KY, Inc dba Vangard Labs RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0615-4515_05a19461-16b8-443f-ab47-ff5c96e3694a 0615-4515 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20051207 ANDA ANDA077272 NCS HealthCare of KY, Inc dba Vangard Labs CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0615-4517_2161c9eb-f496-421c-b603-f10c8c37624c 0615-4517 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20100108 ANDA ANDA070848 NCS HealthCare of KY, Inc dba Vangard Labs SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 0615-4519_84a4b2a6-23a5-411f-82ab-c1a8a5683ed9 0615-4519 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19970328 ANDA ANDA074532 NCS HealthCare of KY, Inc dba Vangard Labs CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-4520_84a4b2a6-23a5-411f-82ab-c1a8a5683ed9 0615-4520 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19970328 ANDA ANDA074532 NCS HealthCare of KY, Inc dba Vangard Labs CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-4521_84a4b2a6-23a5-411f-82ab-c1a8a5683ed9 0615-4521 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19970328 ANDA ANDA074532 NCS HealthCare of KY, Inc dba Vangard Labs CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-4523_afe210f0-1259-41aa-bbfa-c1f835a7bf84 0615-4523 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090921 ANDA ANDA074425 NCS HealthCare of KY, Inc dba Vangard Labs PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 0615-4529_365635c1-79ca-4322-a0d8-c232988dc965 0615-4529 HUMAN OTC DRUG Senna Laxative Sennosides TABLET, COATED ORAL 20110504 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs SENNOSIDES A AND B 8.6 mg/1 0615-4536_21a6d2e6-8373-4f3f-8274-84e888b1dd6d 0615-4536 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 NCS HealthCare of KY, Inc dba Vangard Labs BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0615-4539_923bfb04-e1ec-4651-8d15-a7f93a8e8b1c 0615-4539 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20100114 ANDA ANDA074787 NCS HealthCare of KY, Inc dba Vangard Labs LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-4544_80c1d483-2717-4090-a8ac-a2f9c85fbc5f 0615-4544 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060330 ANDA ANDA076813 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0615-4545_a28410e1-83bd-4399-ab8b-6647477bedce 0615-4545 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 19981223 ANDA ANDA075315 NCS HealthCare of KY, Inc dba Vangard Labs AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 0615-4546_80c1d483-2717-4090-a8ac-a2f9c85fbc5f 0615-4546 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060330 ANDA ANDA076813 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0615-4554_6dc94f73-08c1-465c-bb19-42a4e05de838 0615-4554 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20100804 OTC MONOGRAPH FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ACETAMINOPHEN 325 mg/1 0615-4568_ced86ebc-ceb4-48b0-a3cd-c8026ff478e7 0615-4568 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20111018 ANDA ANDA075091 NCS HealthCare of KY, Inc dba Vangard Labs CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0615-4569_ced86ebc-ceb4-48b0-a3cd-c8026ff478e7 0615-4569 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20111018 ANDA ANDA075091 NCS HealthCare of KY, Inc dba Vangard Labs CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0615-4575_f747d011-89e1-4729-9abf-9df3eed35894 0615-4575 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020301 ANDA ANDA075385 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 10 mg/1 0615-4582_8e053d18-4ca3-4aa7-a11b-07fe99f1c2cf 0615-4582 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100430 ANDA ANDA075511 NCS HealthCare of KY, Inc dba Vangard Labs FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0615-4589_759e0a98-9e32-4caf-936c-873ddf8b85b7 0615-4589 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 NCS HealthCare of KY, Inc dba Vangard Labs ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0615-4590_759e0a98-9e32-4caf-936c-873ddf8b85b7 0615-4590 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 NCS HealthCare of KY, Inc dba Vangard Labs ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0615-4591_759e0a98-9e32-4caf-936c-873ddf8b85b7 0615-4591 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 NCS HealthCare of KY, Inc dba Vangard Labs ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0615-4593_759e0a98-9e32-4caf-936c-873ddf8b85b7 0615-4593 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 NCS HealthCare of KY, Inc dba Vangard Labs ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0615-4594_c007c1bf-9f5c-4c09-a5bd-e2346d756998 0615-4594 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100430 ANDA ANDA075511 NCS HealthCare of KY, Inc dba Vangard Labs FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0615-4595_f747d011-89e1-4729-9abf-9df3eed35894 0615-4595 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020301 ANDA ANDA075385 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 5 mg/1 0615-4596_f747d011-89e1-4729-9abf-9df3eed35894 0615-4596 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020301 ANDA ANDA075385 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 15 mg/1 0615-5501_fb0613bf-4712-4563-aba8-a741a0e3f732 0615-5501 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine TABLET, FILM COATED ORAL 20100113 ANDA ANDA075755 NCS HealthCare of KY, Inc dba Vangard Labs FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-5502_fb0613bf-4712-4563-aba8-a741a0e3f732 0615-5502 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine TABLET, FILM COATED ORAL 20100113 ANDA ANDA075755 NCS HealthCare of KY, Inc dba Vangard Labs FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-5521_5b5d0c35-25e8-4b6f-ae4d-76374421cd74 0615-5521 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100420 ANDA ANDA075752 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-5527_83bdad9f-956e-4844-a19b-d32d493708ce 0615-5527 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20091130 ANDA ANDA076122 NCS HealthCare of KY, Inc dba Vangard Labs MIRTAZAPINE 45 mg/1 0615-5530_5b5d0c35-25e8-4b6f-ae4d-76374421cd74 0615-5530 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100420 ANDA ANDA075752 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-5531_5b5d0c35-25e8-4b6f-ae4d-76374421cd74 0615-5531 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100420 ANDA ANDA075752 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-5532_8563c9ce-6096-413d-a45b-b3090d1f115c 0615-5532 HUMAN OTC DRUG Fiber Lax CALCIUM POLYCARBOPHIL TABLET, FILM COATED ORAL 20100901 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs CALCIUM POLYCARBOPHIL 625 mg/1 0615-5533_e9986c17-4f29-4207-a82d-3f7323012bdc 0615-5533 HUMAN OTC DRUG Senna Plus Sennosides and Docusate Sodium TABLET ORAL 20110616 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 0615-5534_21a6d2e6-8373-4f3f-8274-84e888b1dd6d 0615-5534 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 NCS HealthCare of KY, Inc dba Vangard Labs BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0615-5535_be424ba7-c9ec-4eb0-853c-f56665fe0b9c 0615-5535 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0615-5536_ace11116-05af-4378-99bd-ee2f4b2aee75 0615-5536 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin mesylate TABLET ORAL 20001019 ANDA ANDA075509 NCS HealthCare of KY, Inc dba Vangard Labs DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0615-5537_ace11116-05af-4378-99bd-ee2f4b2aee75 0615-5537 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin mesylate TABLET ORAL 20001019 ANDA ANDA075509 NCS HealthCare of KY, Inc dba Vangard Labs DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0615-5538_5b5d0c35-25e8-4b6f-ae4d-76374421cd74 0615-5538 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100420 ANDA ANDA075752 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-5539_5b5d0c35-25e8-4b6f-ae4d-76374421cd74 0615-5539 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100420 ANDA ANDA075752 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-5540_5b5d0c35-25e8-4b6f-ae4d-76374421cd74 0615-5540 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100420 ANDA ANDA075752 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-5541_a90a7ddb-457e-4ab4-b63e-c9f3b186f26a 0615-5541 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100630 ANDA ANDA090649 NCS HealthCare of KY, Inc dba Vangard Labs NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0615-5548_8b1f1f00-8f73-4036-899d-4eb445910cb4 0615-5548 HUMAN PRESCRIPTION DRUG BusPIRone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20050601 ANDA ANDA075467 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 7.5 mg/1 0615-5549_20147b6e-d77f-4031-a5de-3f62383c7c14 0615-5549 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET ORAL 19981030 ANDA ANDA075037 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0615-5550_20147b6e-d77f-4031-a5de-3f62383c7c14 0615-5550 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET ORAL 19981030 ANDA ANDA075037 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0615-5552_7d61f28c-fe77-46c1-ace4-34b701ce4e5f 0615-5552 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 NCS HealthCare of KY, Inc dba Vangard Labs SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 0615-5554_be424ba7-c9ec-4eb0-853c-f56665fe0b9c 0615-5554 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0615-5559_f4616553-a74b-44cc-89f1-7772bb2c7bac 0615-5559 HUMAN PRESCRIPTION DRUG Klor Con M potassium chloride TABLET, EXTENDED RELEASE ORAL 19981120 ANDA ANDA074726 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0615-5572_83bdad9f-956e-4844-a19b-d32d493708ce 0615-5572 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20091130 ANDA ANDA076122 NCS HealthCare of KY, Inc dba Vangard Labs MIRTAZAPINE 15 mg/1 0615-5573_83bdad9f-956e-4844-a19b-d32d493708ce 0615-5573 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20091130 ANDA ANDA076122 NCS HealthCare of KY, Inc dba Vangard Labs MIRTAZAPINE 30 mg/1 0615-5574_80faf4ac-0679-45d1-bd2c-c9b1cdc2ae68 0615-5574 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 NCS HealthCare of KY, Inc dba Vangard Labs TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0615-5575_4d358ce1-40ae-4753-867e-b48d23dba2ef 0615-5575 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110719 ANDA ANDA076346 NCS HealthCare of KY, Inc dba Vangard Labs TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0615-5576_641d859d-3a27-4b7d-9c9f-e2b0cbb3a449 0615-5576 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070307 ANDA ANDA077584 NCS HealthCare of KY, Inc dba Vangard Labs PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-5577_641d859d-3a27-4b7d-9c9f-e2b0cbb3a449 0615-5577 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070307 ANDA ANDA077584 NCS HealthCare of KY, Inc dba Vangard Labs PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-5578_641d859d-3a27-4b7d-9c9f-e2b0cbb3a449 0615-5578 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070307 ANDA ANDA077584 NCS HealthCare of KY, Inc dba Vangard Labs PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-5579_641d859d-3a27-4b7d-9c9f-e2b0cbb3a449 0615-5579 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070307 ANDA ANDA077584 NCS HealthCare of KY, Inc dba Vangard Labs PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-5583_eb42803c-ac3f-418a-a5d7-cf81e479f8b1 0615-5583 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100611 ANDA ANDA076269 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0615-5584_04f7ce27-0809-4974-9850-7d1c10dd1ad5 0615-5584 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, EXTENDED RELEASE ORAL 20030908 ANDA ANDA076467 NCS HealthCare of KY, Inc dba Vangard Labs GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0615-5585_04f7ce27-0809-4974-9850-7d1c10dd1ad5 0615-5585 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, EXTENDED RELEASE ORAL 20030908 ANDA ANDA076467 NCS HealthCare of KY, Inc dba Vangard Labs GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0615-5586_4bd4aebe-5d12-43a7-b079-26bc93cebb63 0615-5586 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030121 ANDA ANDA075209 NCS HealthCare of KY, Inc dba Vangard Labs LORATADINE 10 mg/1 0615-5589_0466fea6-e576-4c71-943e-9ec5038f79a2 0615-5589 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 NCS HealthCare of KY, Inc dba Vangard Labs LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-5591_4bd1672f-54df-4a23-a7cd-dd63d302abdc 0615-5591 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20010524 ANDA ANDA084903 NCS HealthCare of KY, Inc dba Vangard Labs PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-5592_c811c81f-84d9-4d55-bbd4-2b30a6e5a32d 0615-5592 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20010820 ANDA ANDA040424 NCS HealthCare of KY, Inc dba Vangard Labs SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0615-5593_5392708b-ded5-44c8-87cd-afe79564794b 0615-5593 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041028 ANDA ANDA076832 NCS HealthCare of KY, Inc dba Vangard Labs LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 0615-5619_cbebe8fd-aaea-4564-8e6d-0d35fcda8ac1 0615-5619 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20000225 NDA NDA020872 NCS HealthCare of KY, Inc dba Vangard Labs FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0615-5620_cbebe8fd-aaea-4564-8e6d-0d35fcda8ac1 0615-5620 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20000225 NDA NDA020872 NCS HealthCare of KY, Inc dba Vangard Labs FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0615-5647_8da8c36d-8167-4eeb-a788-4d777bcff619 0615-5647 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride Midodrine Hydrochloride TABLET ORAL 20030910 ANDA ANDA076577 NCS HealthCare of KY, Inc dba Vangard Labs MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0615-5649_6e9ef933-24b0-4b08-bd4d-a25df09c7c38 0615-5649 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19830927 ANDA ANDA088391 NCS HealthCare of KY, Inc dba Vangard Labs HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 0615-6500_e897d664-2a02-4d94-ab61-93252204ccd7 0615-6500 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20010327 ANDA ANDA040411 NCS HealthCare of KY, Inc dba Vangard Labs METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 0615-6501_b7334070-8c15-4dee-ae49-8664f3d0f8fb 0615-6501 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20031219 ANDA ANDA076732 NCS HealthCare of KY, Inc dba Vangard Labs METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0615-6502_b7334070-8c15-4dee-ae49-8664f3d0f8fb 0615-6502 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20031219 ANDA ANDA076732 NCS HealthCare of KY, Inc dba Vangard Labs METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0615-6510_7d3a4bb2-fce0-43f1-88e3-e52ccf8133ec 0615-6510 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20070222 ANDA ANDA077048 NCS HealthCare of KY, Inc dba Vangard Labs CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-6511_6515adfa-9620-4a60-b07b-4d106828bfe8 0615-6511 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20070222 ANDA ANDA077048 NCS HealthCare of KY, Inc dba Vangard Labs CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-6512_7d3a4bb2-fce0-43f1-88e3-e52ccf8133ec 0615-6512 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20071108 ANDA ANDA077048 NCS HealthCare of KY, Inc dba Vangard Labs CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-6516_255e03dc-b1a1-4660-8c07-ede81b9f1e5e 0615-6516 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087800 NCS HealthCare of KY, Inc dba Vangard Labs PREDNISONE 1 mg/1 0615-6547_660d179a-5619-465b-a33d-6fb1b1d23e37 0615-6547 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20110505 ANDA ANDA076704 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-6548_7e1d0a80-81a7-4031-8f7e-40f319700d79 0615-6548 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20041021 ANDA ANDA075694 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-6551_0466fea6-e576-4c71-943e-9ec5038f79a2 0615-6551 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 NCS HealthCare of KY, Inc dba Vangard Labs LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-6553_6368546a-d551-4e72-8949-8647e8416903 0615-6553 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0615-6554_7e1d0a80-81a7-4031-8f7e-40f319700d79 0615-6554 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20041021 ANDA ANDA075694 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-6556_18862fca-d643-474b-b1af-6af180f2c45f 0615-6556 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20110722 ANDA ANDA076056 NCS HealthCare of KY, Inc dba Vangard Labs PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-6557_18862fca-d643-474b-b1af-6af180f2c45f 0615-6557 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastain Sodium TABLET ORAL 20110722 ANDA ANDA076056 NCS HealthCare of KY, Inc dba Vangard Labs PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-6558_6a262310-9841-4240-8f73-1eb4742d2576 0615-6558 HUMAN PRESCRIPTION DRUG Sertraline Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 NCS HealthCare of KY, Inc dba Vangard Labs SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-6559_6a262310-9841-4240-8f73-1eb4742d2576 0615-6559 HUMAN PRESCRIPTION DRUG Sertraline Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 NCS HealthCare of KY, Inc dba Vangard Labs SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-6560_6a262310-9841-4240-8f73-1eb4742d2576 0615-6560 HUMAN PRESCRIPTION DRUG Sertraline Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 NCS HealthCare of KY, Inc dba Vangard Labs SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-6561_6368546a-d551-4e72-8949-8647e8416903 0615-6561 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0615-6562_fe7acbb8-148a-4932-ac78-514cc7d17729 0615-6562 HUMAN PRESCRIPTION DRUG Fludrocortisone Acetate FLUDROCORTISONE ACETATE TABLET ORAL 20020330 ANDA ANDA040431 NCS HealthCare of KY, Inc dba Vangard Labs FLUDROCORTISONE ACETATE .1 mg/1 0615-6563_a90a7ddb-457e-4ab4-b63e-c9f3b186f26a 0615-6563 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100630 ANDA ANDA090649 NCS HealthCare of KY, Inc dba Vangard Labs NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0615-6564_80faf4ac-0679-45d1-bd2c-c9b1cdc2ae68 0615-6564 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 NCS HealthCare of KY, Inc dba Vangard Labs TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0615-6566_f116f679-6ab0-4aec-9837-01b9acbffba4 0615-6566 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 NCS HealthCare of KY, Inc dba Vangard Labs VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-6567_4cf939f3-8eda-42c2-84f4-45405768fa97 0615-6567 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 NCS HealthCare of KY, Inc dba Vangard Labs VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-6568_e98bfbdb-79c3-451c-86c2-3213a8c4b9f6 0615-6568 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060720 ANDA ANDA077936 NCS HealthCare of KY, Inc dba Vangard Labs MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0615-6569_e98bfbdb-79c3-451c-86c2-3213a8c4b9f6 0615-6569 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060720 ANDA ANDA077936 NCS HealthCare of KY, Inc dba Vangard Labs MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0615-6570_ace11116-05af-4378-99bd-ee2f4b2aee75 0615-6570 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin mesylate TABLET ORAL 20001019 ANDA ANDA075509 NCS HealthCare of KY, Inc dba Vangard Labs DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0615-6571_ace11116-05af-4378-99bd-ee2f4b2aee75 0615-6571 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin mesylate TABLET ORAL 20001019 ANDA ANDA075509 NCS HealthCare of KY, Inc dba Vangard Labs DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0615-6572_1b5decaf-f1c9-44b7-9b2d-de3fc5b7cc99 0615-6572 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091116 ANDA ANDA078855 NCS HealthCare of KY, Inc dba Vangard Labs FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0615-6573_1b5decaf-f1c9-44b7-9b2d-de3fc5b7cc99 0615-6573 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091116 ANDA ANDA078855 NCS HealthCare of KY, Inc dba Vangard Labs FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0615-6575_9b447065-35ee-4312-9f1e-ac4b4739254b 0615-6575 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 NCS HealthCare of KY, Inc dba Vangard Labs GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0615-6576_9b447065-35ee-4312-9f1e-ac4b4739254b 0615-6576 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 NCS HealthCare of KY, Inc dba Vangard Labs GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0615-6577_789f7015-8b9c-4c80-98ea-71acdf80581c 0615-6577 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20110311 ANDA ANDA076418 NCS HealthCare of KY, Inc dba Vangard Labs AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0615-6578_789f7015-8b9c-4c80-98ea-71acdf80581c 0615-6578 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20110311 ANDA ANDA076418 NCS HealthCare of KY, Inc dba Vangard Labs AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0615-6579_f18ea5e0-cf1d-491d-8a03-9149e3bd2940 0615-6579 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-6580_f18ea5e0-cf1d-491d-8a03-9149e3bd2940 0615-6580 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-6581_f18ea5e0-cf1d-491d-8a03-9149e3bd2940 0615-6581 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-6582_789f7015-8b9c-4c80-98ea-71acdf80581c 0615-6582 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine TABLET ORAL 20110311 ANDA ANDA076418 NCS HealthCare of KY, Inc dba Vangard Labs AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0615-6583_14c8ab86-5067-45e3-adad-a7ccab1a9888 0615-6583 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 NCS HealthCare of KY, Inc dba Vangard Labs CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0615-6584_14c8ab86-5067-45e3-adad-a7ccab1a9888 0615-6584 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 NCS HealthCare of KY, Inc dba Vangard Labs CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0615-6585_14c8ab86-5067-45e3-adad-a7ccab1a9888 0615-6585 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 NCS HealthCare of KY, Inc dba Vangard Labs CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0615-6586_14c8ab86-5067-45e3-adad-a7ccab1a9888 0615-6586 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070906 ANDA ANDA078227 NCS HealthCare of KY, Inc dba Vangard Labs CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0615-6587_f18ea5e0-cf1d-491d-8a03-9149e3bd2940 0615-6587 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20070816 ANDA ANDA078425 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-6588_f18ea5e0-cf1d-491d-8a03-9149e3bd2940 0615-6588 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-6589_e6754ab2-e9e5-4537-a853-a40a77b8b4b0 0615-6589 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-6590_0466fea6-e576-4c71-943e-9ec5038f79a2 0615-6590 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 NCS HealthCare of KY, Inc dba Vangard Labs LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-6591_c811c81f-84d9-4d55-bbd4-2b30a6e5a32d 0615-6591 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20010820 ANDA ANDA040424 NCS HealthCare of KY, Inc dba Vangard Labs SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0615-6593_bc8435d1-100a-41f6-9bec-6d1c85783e84 0615-6593 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 NCS HealthCare of KY, Inc dba Vangard Labs OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-6594_bc8435d1-100a-41f6-9bec-6d1c85783e84 0615-6594 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 NCS HealthCare of KY, Inc dba Vangard Labs OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-6595_bc8435d1-100a-41f6-9bec-6d1c85783e84 0615-6595 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 NCS HealthCare of KY, Inc dba Vangard Labs OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-6596_04f7ce27-0809-4974-9850-7d1c10dd1ad5 0615-6596 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, EXTENDED RELEASE ORAL 20030908 ANDA ANDA076467 NCS HealthCare of KY, Inc dba Vangard Labs GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0615-6597_e6754ab2-e9e5-4537-a853-a40a77b8b4b0 0615-6597 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-6598_e6754ab2-e9e5-4537-a853-a40a77b8b4b0 0615-6598 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-7505_ab00adc0-05be-4ffa-aea4-cc6eeac1ed9c 0615-7505 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20100407 ANDA ANDA076288 NCS HealthCare of KY, Inc dba Vangard Labs RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 0615-7506_ab00adc0-05be-4ffa-aea4-cc6eeac1ed9c 0615-7506 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20100407 ANDA ANDA076288 NCS HealthCare of KY, Inc dba Vangard Labs RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 0615-7507_ab00adc0-05be-4ffa-aea4-cc6eeac1ed9c 0615-7507 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20100407 ANDA ANDA076288 NCS HealthCare of KY, Inc dba Vangard Labs RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 0615-7508_ab00adc0-05be-4ffa-aea4-cc6eeac1ed9c 0615-7508 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20100407 ANDA ANDA076288 NCS HealthCare of KY, Inc dba Vangard Labs RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 0615-7513_ab00adc0-05be-4ffa-aea4-cc6eeac1ed9c 0615-7513 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20100407 ANDA ANDA076288 NCS HealthCare of KY, Inc dba Vangard Labs RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 0615-7514_ab00adc0-05be-4ffa-aea4-cc6eeac1ed9c 0615-7514 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20100407 ANDA ANDA076288 NCS HealthCare of KY, Inc dba Vangard Labs RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 0615-7519_aa1bc036-40af-49f0-9dfc-4e15b81ea2e5 0615-7519 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100120 ANDA ANDA076702 NCS HealthCare of KY, Inc dba Vangard Labs OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0615-7520_aa1bc036-40af-49f0-9dfc-4e15b81ea2e5 0615-7520 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100120 ANDA ANDA076644 NCS HealthCare of KY, Inc dba Vangard Labs OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0615-7521_e53fc330-b0d8-4441-8c1e-8562042d3bb4 0615-7521 HUMAN PRESCRIPTION DRUG oxybutynin chloride oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 20070510 NDA NDA020897 NCS HealthCare of KY, Inc dba Vangard Labs OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0615-7522_bf7c6a83-25d3-4f08-b4d1-60e3e444a18d 0615-7522 HUMAN OTC DRUG Cetirizine Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077946 NCS HealthCare of KY, Inc dba Vangard Labs CETIRIZINE HYDROCHLORIDE 10 mg/1 0615-7523_9b447065-35ee-4312-9f1e-ac4b4739254b 0615-7523 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 NCS HealthCare of KY, Inc dba Vangard Labs GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0615-7528_23ae4858-2793-41f9-b621-1f626962e11c 0615-7528 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 NCS HealthCare of KY, Inc dba Vangard Labs CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0615-7530_e6754ab2-e9e5-4537-a853-a40a77b8b4b0 0615-7530 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-7531_1fbb3a5a-960b-45f5-8fe2-2cea7685617a 0615-7531 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110121 ANDA ANDA078182 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0615-7532_1fbb3a5a-960b-45f5-8fe2-2cea7685617a 0615-7532 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110121 ANDA ANDA078182 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0615-7533_1fbb3a5a-960b-45f5-8fe2-2cea7685617a 0615-7533 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110121 ANDA ANDA078182 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0615-7536_5774cadb-5f61-47a2-95f8-cc73146016de 0615-7536 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET ORAL 20111027 ANDA ANDA078881 NCS HealthCare of KY, Inc dba Vangard Labs ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0615-7537_5774cadb-5f61-47a2-95f8-cc73146016de 0615-7537 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET ORAL 20111027 ANDA ANDA078881 NCS HealthCare of KY, Inc dba Vangard Labs ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0615-7538_5774cadb-5f61-47a2-95f8-cc73146016de 0615-7538 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET ORAL 20111027 ANDA ANDA078881 NCS HealthCare of KY, Inc dba Vangard Labs ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0615-7539_5774cadb-5f61-47a2-95f8-cc73146016de 0615-7539 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET ORAL 20111027 ANDA ANDA078881 NCS HealthCare of KY, Inc dba Vangard Labs ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0615-7541_0d8bcf2c-16eb-4813-90a6-99ae712f1d5c 0615-7541 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20090529 ANDA ANDA077590 NCS HealthCare of KY, Inc dba Vangard Labs GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0615-7542_0d8bcf2c-16eb-4813-90a6-99ae712f1d5c 0615-7542 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20090529 ANDA ANDA077590 NCS HealthCare of KY, Inc dba Vangard Labs GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0615-7543_0d8bcf2c-16eb-4813-90a6-99ae712f1d5c 0615-7543 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20090529 ANDA ANDA077590 NCS HealthCare of KY, Inc dba Vangard Labs GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0615-7544_79932a2f-5cb8-4d47-98c1-a3ddb53ff29a 0615-7544 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20100427 ANDA ANDA076388 NCS HealthCare of KY, Inc dba Vangard Labs LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0615-7545_79932a2f-5cb8-4d47-98c1-a3ddb53ff29a 0615-7545 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20100427 ANDA ANDA076388 NCS HealthCare of KY, Inc dba Vangard Labs LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0615-7546_79932a2f-5cb8-4d47-98c1-a3ddb53ff29a 0615-7546 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20100427 ANDA ANDA076388 NCS HealthCare of KY, Inc dba Vangard Labs LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0615-7547_79932a2f-5cb8-4d47-98c1-a3ddb53ff29a 0615-7547 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20100427 ANDA ANDA076388 NCS HealthCare of KY, Inc dba Vangard Labs LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0615-7548_bdda5eba-bfcc-42e3-834f-860e08d72d82 0615-7548 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 NCS HealthCare of KY, Inc dba Vangard Labs FENOFIBRATE 200 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0615-7549_321617aa-3c20-4330-8c8c-7d964d5cab39 0615-7549 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20110117 ANDA ANDA077122 NCS HealthCare of KY, Inc dba Vangard Labs DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 0615-7550_04ff213f-d9e2-4b31-9017-ee6db74432d0 0615-7550 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20111129 ANDA ANDA076919 NCS HealthCare of KY, Inc dba Vangard Labs LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-7551_04ff213f-d9e2-4b31-9017-ee6db74432d0 0615-7551 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20111129 ANDA ANDA076919 NCS HealthCare of KY, Inc dba Vangard Labs LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-7552_04ff213f-d9e2-4b31-9017-ee6db74432d0 0615-7552 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20111129 ANDA ANDA076919 NCS HealthCare of KY, Inc dba Vangard Labs LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-7553_e76ae452-aa4d-4a81-b15a-6821e7473bb6 0615-7553 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078904 NCS HealthCare of KY, Inc dba Vangard Labs LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-7554_4bf66480-7407-4c36-9f6b-e9085ff93517 0615-7554 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100208 ANDA ANDA077567 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0615-7555_4bf66480-7407-4c36-9f6b-e9085ff93517 0615-7555 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100208 ANDA ANDA077567 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0615-7557_4cf939f3-8eda-42c2-84f4-45405768fa97 0615-7557 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 NCS HealthCare of KY, Inc dba Vangard Labs VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-7558_4cf939f3-8eda-42c2-84f4-45405768fa97 0615-7558 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 NCS HealthCare of KY, Inc dba Vangard Labs VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-7559_8da8c36d-8167-4eeb-a788-4d777bcff619 0615-7559 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride Midodrine Hydrochloride TABLET ORAL 20030910 ANDA ANDA076577 NCS HealthCare of KY, Inc dba Vangard Labs MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0615-7560_ce742cde-f442-4923-9dc8-2b33d5affa00 0615-7560 HUMAN PRESCRIPTION DRUG BUDEPRION XL XL BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20061214 ANDA ANDA077284 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0615-7562_d8d1e518-2b20-4a4b-bd1d-f13c9f762d7a 0615-7562 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 NCS HealthCare of KY, Inc dba Vangard Labs TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-7563_d8d1e518-2b20-4a4b-bd1d-f13c9f762d7a 0615-7563 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 NCS HealthCare of KY, Inc dba Vangard Labs TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-7564_d8d1e518-2b20-4a4b-bd1d-f13c9f762d7a 0615-7564 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 NCS HealthCare of KY, Inc dba Vangard Labs TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-7565_d8d1e518-2b20-4a4b-bd1d-f13c9f762d7a 0615-7565 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 NCS HealthCare of KY, Inc dba Vangard Labs TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-7566_8da8c36d-8167-4eeb-a788-4d777bcff619 0615-7566 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride Midodrine Hydrochloride TABLET ORAL 20030910 ANDA ANDA076577 NCS HealthCare of KY, Inc dba Vangard Labs MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 0615-7567_5774cadb-5f61-47a2-95f8-cc73146016de 0615-7567 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET ORAL 20111027 ANDA ANDA078881 NCS HealthCare of KY, Inc dba Vangard Labs ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0615-7568_011f3ad5-2b31-4560-9aad-ae158eff396d 0615-7568 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 19960216 ANDA ANDA074069 NCS HealthCare of KY, Inc dba Vangard Labs AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 0615-7569_37c5c6bd-6df6-4f8c-b7f1-c19bb8d8243e 0615-7569 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET, FILM COATED ORAL 20100312 ANDA ANDA075893 NCS HealthCare of KY, Inc dba Vangard Labs FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-7570_a6771890-b58f-4154-b584-9a145c6fd77c 0615-7570 HUMAN PRESCRIPTION DRUG Pravastatin Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA076714 NCS HealthCare of KY, Inc dba Vangard Labs PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-7571_a90a7ddb-457e-4ab4-b63e-c9f3b186f26a 0615-7571 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110628 ANDA ANDA090649 NCS HealthCare of KY, Inc dba Vangard Labs NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0615-7572_a7408291-0f62-4397-b715-fd6460a84a62 0615-7572 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030109 ANDA ANDA040489 NCS HealthCare of KY, Inc dba Vangard Labs METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0615-7573_a7408291-0f62-4397-b715-fd6460a84a62 0615-7573 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 NCS HealthCare of KY, Inc dba Vangard Labs METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0615-7574_a3a897b6-f45b-404d-a7f2-1b1811002b98 0615-7574 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride Propafenone Hydrochloride TABLET, FILM COATED ORAL 20021017 ANDA ANDA075938 NCS HealthCare of KY, Inc dba Vangard Labs PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] 0615-7575_3e34809d-5f18-4445-b885-e1cea1c6e322 0615-7575 HUMAN PRESCRIPTION DRUG Folbic Pyridoxine and Cyanocobalamin and Folic Acid TABLET ORAL 20100219 UNAPPROVED DRUG OTHER NCS HealthCare of KY, Inc dba Vangard Labs CYANOCOBALAMIN; FOLIC ACID; PYRIDOXINE 2; 2.5; 25 mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 0615-7576_2abcaa61-9a90-4a98-b045-95d7e861cf44 0615-7576 HUMAN PRESCRIPTION DRUG GLYCOPYRROLATE GLYCOPYRROLATE TABLET ORAL 20041230 ANDA ANDA040568 NCS HealthCare of KY, Inc dba Vangard Labs GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0615-7577_73ba838d-7be2-4fbf-b307-3ce8f6db4210 0615-7577 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20110913 ANDA ANDA075776 NCS HealthCare of KY, Inc dba Vangard Labs HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0615-7581_73ba838d-7be2-4fbf-b307-3ce8f6db4210 0615-7581 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20110913 ANDA ANDA075776 NCS HealthCare of KY, Inc dba Vangard Labs HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0615-7582_73ba838d-7be2-4fbf-b307-3ce8f6db4210 0615-7582 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20110913 ANDA ANDA075776 NCS HealthCare of KY, Inc dba Vangard Labs HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0615-7583_193d716d-402c-400b-86c7-12ca86a280dc 0615-7583 HUMAN PRESCRIPTION DRUG propylthiouracil propylthiouracil TABLET ORAL 19730109 ANDA ANDA080172 NCS HealthCare of KY, Inc dba Vangard Labs PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 0615-7584_81519143-1c49-47d7-9924-51e22063ae6a 0615-7584 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19830210 ANDA ANDA087946 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE DINITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0615-7585_9edae1d0-63c3-4a88-9902-d07722f1e930 0615-7585 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20090908 ANDA ANDA077463 NCS HealthCare of KY, Inc dba Vangard Labs NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0615-7586_9edae1d0-63c3-4a88-9902-d07722f1e930 0615-7586 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20090908 ANDA ANDA077463 NCS HealthCare of KY, Inc dba Vangard Labs NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0615-7590_9bca01b0-ca2c-48df-8a16-bbe29d09beb7 0615-7590 HUMAN OTC DRUG Acetaminophen Extended Release Acetaminophen TABLET ORAL 20000225 ANDA ANDA075077 NCS HealthCare of KY, Inc dba Vangard Labs ACETAMINOPHEN 650 mg/1 0615-7591_bbe3424d-45e4-44f9-80a8-730e08049483 0615-7591 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 NCS HealthCare of KY, Inc dba Vangard Labs CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0615-7593_4fe14aa2-eafb-4a3f-b04c-c0d9cb90b5e4 0615-7593 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 19881114 ANDA ANDA071826 NCS HealthCare of KY, Inc dba Vangard Labs MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 0615-7597_9a8d5c03-8596-491b-8cc0-89b7acfdfca5 0615-7597 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100101 ANDA ANDA077724 NCS HealthCare of KY, Inc dba Vangard Labs PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0615-7604_672c842b-a519-4413-920d-6bfbbf94b68b 0615-7604 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101228 ANDA ANDA076958 NCS HealthCare of KY, Inc dba Vangard Labs LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0615-7605_672c842b-a519-4413-920d-6bfbbf94b68b 0615-7605 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101228 ANDA ANDA076958 NCS HealthCare of KY, Inc dba Vangard Labs LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0615-7606_672c842b-a519-4413-920d-6bfbbf94b68b 0615-7606 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101228 ANDA ANDA076958 NCS HealthCare of KY, Inc dba Vangard Labs LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0615-7607_52496b1e-ddec-4722-97fa-5b97e090e30c 0615-7607 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20100429 ANDA ANDA090408 NCS HealthCare of KY, Inc dba Vangard Labs TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0615-7613_e897d664-2a02-4d94-ab61-93252204ccd7 0615-7613 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20010327 ANDA ANDA040411 NCS HealthCare of KY, Inc dba Vangard Labs METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 0615-7618_4ca4589b-28bd-4f8d-b1e8-3a4ba4323253 0615-7618 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070995 NCS HealthCare of KY, Inc dba Vangard Labs VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0615-7619_4ca4589b-28bd-4f8d-b1e8-3a4ba4323253 0615-7619 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070994 NCS HealthCare of KY, Inc dba Vangard Labs VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0615-7620_528c83d0-fbc8-4fc5-9a47-0a6450e46297 0615-7620 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100628 ANDA ANDA076565 NCS HealthCare of KY, Inc dba Vangard Labs VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-7623_012959a5-397a-4d92-8758-656327a64ed6 0615-7623 HUMAN PRESCRIPTION DRUG donepezil hydrochloride DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 19961126 NDA NDA020690 NCS HealthCare of KY, Inc dba Vangard Labs DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0615-7624_012959a5-397a-4d92-8758-656327a64ed6 0615-7624 HUMAN PRESCRIPTION DRUG donepezil hydrochloride DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 19961126 NDA NDA020690 NCS HealthCare of KY, Inc dba Vangard Labs DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0615-7625_dedbd1ce-3775-48ba-827b-73a876dc0ba8 0615-7625 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20120320 ANDA ANDA076001 NCS HealthCare of KY, Inc dba Vangard Labs FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-7626_68c525af-34dc-4bc3-b392-faa98017e24f 0615-7626 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0615-7627_68c525af-34dc-4bc3-b392-faa98017e24f 0615-7627 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0615-7628_68c525af-34dc-4bc3-b392-faa98017e24f 0615-7628 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0615-7629_fdccfeb8-db06-44ff-ab56-1a2e1f1c8e80 0615-7629 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20120123 ANDA ANDA090970 NCS HealthCare of KY, Inc dba Vangard Labs PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0615-7630_37f76c65-fba3-458e-9029-b48ee61a11c8 0615-7630 HUMAN PRESCRIPTION DRUG Nabumetone nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 NCS HealthCare of KY, Inc dba Vangard Labs NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0615-7631_bbeedc69-56c3-44e2-b594-0c05d1f08942 0615-7631 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100201 ANDA ANDA075491 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0615-7632_bbeedc69-56c3-44e2-b594-0c05d1f08942 0615-7632 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100201 ANDA ANDA075491 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0615-7633_68145eef-7e8e-4817-bab3-8ca8d579ce85 0615-7633 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20101223 ANDA ANDA075022 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 5 mg/1 0615-7634_68145eef-7e8e-4817-bab3-8ca8d579ce85 0615-7634 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20101223 ANDA ANDA075022 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 10 mg/1 0615-7635_68145eef-7e8e-4817-bab3-8ca8d579ce85 0615-7635 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20101223 ANDA ANDA075022 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 15 mg/1 0615-7636_d2c9e88a-df18-4ba7-be45-13cf14b0d6c9 0615-7636 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20100701 ANDA ANDA076447 NCS HealthCare of KY, Inc dba Vangard Labs FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0615-7638_dedbd1ce-3775-48ba-827b-73a876dc0ba8 0615-7638 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20120320 ANDA ANDA076001 NCS HealthCare of KY, Inc dba Vangard Labs FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-7639_35e2befc-faf9-486b-97d3-71f98e7e6982 0615-7639 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET, FILM COATED ORAL 20070419 ANDA ANDA078402 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-7640_35e2befc-faf9-486b-97d3-71f98e7e6982 0615-7640 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET, FILM COATED ORAL 20070419 ANDA ANDA078402 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-7641_35e2befc-faf9-486b-97d3-71f98e7e6982 0615-7641 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET, FILM COATED ORAL 20070419 ANDA ANDA078402 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-7642_35e2befc-faf9-486b-97d3-71f98e7e6982 0615-7642 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET, FILM COATED ORAL 20070419 ANDA ANDA078402 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-7643_35e2befc-faf9-486b-97d3-71f98e7e6982 0615-7643 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET, FILM COATED ORAL 20070419 ANDA ANDA078402 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-7644_35e2befc-faf9-486b-97d3-71f98e7e6982 0615-7644 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET, FILM COATED ORAL 20070419 ANDA ANDA078402 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-7645_37f76c65-fba3-458e-9029-b48ee61a11c8 0615-7645 HUMAN PRESCRIPTION DRUG Nabumetone nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 NCS HealthCare of KY, Inc dba Vangard Labs NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0615-7646_d2518f4d-eafc-4107-ba76-5453bb220927 0615-7646 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20101025 NDA AUTHORIZED GENERIC NDA018238 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0615-7653_7879f700-695d-4ab5-b3b3-dfbb349853a7 0615-7653 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA201001 NCS HealthCare of KY, Inc dba Vangard Labs DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0615-7654_7879f700-695d-4ab5-b3b3-dfbb349853a7 0615-7654 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA201001 NCS HealthCare of KY, Inc dba Vangard Labs DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0615-7655_c8974e25-2da4-4113-b7ef-4707587488c3 0615-7655 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin CAPSULE ORAL 20110506 ANDA ANDA074967 NCS HealthCare of KY, Inc dba Vangard Labs NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 0615-7656_0e08d748-79fa-40fd-baea-e3d219a82c35 0615-7656 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20090102 OTC MONOGRAPH FINAL part341 NCS HealthCare of KY, Inc dba Vangard Labs DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0615-7657_9060e29c-a706-4d3b-8f12-cfa811d7350c 0615-7657 HUMAN OTC DRUG DIPHENDYDRAMINE HYDROCHLORIDE DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20090102 OTC MONOGRAPH FINAL part336 NCS HealthCare of KY, Inc dba Vangard Labs DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 0615-7659_cd644ad1-e040-47b2-962c-a7c00803498c 0615-7659 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100719 ANDA ANDA077455 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0615-7660_cd644ad1-e040-47b2-962c-a7c00803498c 0615-7660 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080312 ANDA ANDA077455 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0615-7661_ed35b37e-01c8-4ee0-892a-fa1a3ffdec65 0615-7661 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20100727 ANDA ANDA075978 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0615-7662_ed35b37e-01c8-4ee0-892a-fa1a3ffdec65 0615-7662 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20100727 ANDA ANDA075978 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0615-7663_ed35b37e-01c8-4ee0-892a-fa1a3ffdec65 0615-7663 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20100727 ANDA ANDA075978 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0615-7666_e76bd28e-31d6-4de4-bec4-4f5049c5a5da 0615-7666 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20100122 ANDA ANDA075189 NCS HealthCare of KY, Inc dba Vangard Labs NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0615-7667_54a6ebca-d297-4ebe-b9b0-0c8d2b446a77 0615-7667 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20100122 ANDA ANDA075189 NCS HealthCare of KY, Inc dba Vangard Labs NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0615-7668_c46448aa-df52-44e0-882d-1bf2919c817a 0615-7668 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20090127 ANDA ANDA040863 NCS HealthCare of KY, Inc dba Vangard Labs PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0615-7674_c2f40cba-8a84-475a-a74b-12e722d8e9ae 0615-7674 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20111101 ANDA ANDA075828 NCS HealthCare of KY, Inc dba Vangard Labs LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-7675_a56bcb74-de50-4c37-9c79-dd33abe04687 0615-7675 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 19961212 ANDA ANDA040103 NCS HealthCare of KY, Inc dba Vangard Labs BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0615-7676_a56bcb74-de50-4c37-9c79-dd33abe04687 0615-7676 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 19961212 ANDA ANDA040103 NCS HealthCare of KY, Inc dba Vangard Labs BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0615-7677_a56bcb74-de50-4c37-9c79-dd33abe04687 0615-7677 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 19961212 ANDA ANDA040103 NCS HealthCare of KY, Inc dba Vangard Labs BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0615-7678_5477b3da-5999-430b-815b-394cfd786d19 0615-7678 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070904 ANDA ANDA040597 NCS HealthCare of KY, Inc dba Vangard Labs BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 0615-7679_495dfca9-c3e6-4efe-a30a-e99906e735a2 0615-7679 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 NCS HealthCare of KY, Inc dba Vangard Labs LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-7683_553514ae-c2af-4c46-b6b3-2aa285a646f7 0615-7683 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084113 NCS HealthCare of KY, Inc dba Vangard Labs CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0615-7684_5866e047-f439-4133-9216-87ac2db690ae 0615-7684 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078858 NCS HealthCare of KY, Inc dba Vangard Labs LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-7685_d7461921-fd95-4d44-80cb-b966dbf5e2eb 0615-7685 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 NCS HealthCare of KY, Inc dba Vangard Labs LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-7686_130580ab-9628-452b-b05f-2bd1781b2097 0615-7686 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20110101 ANDA ANDA074787 NCS HealthCare of KY, Inc dba Vangard Labs LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-7687_130580ab-9628-452b-b05f-2bd1781b2097 0615-7687 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20110101 ANDA ANDA074787 NCS HealthCare of KY, Inc dba Vangard Labs LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-7688_130580ab-9628-452b-b05f-2bd1781b2097 0615-7688 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20110101 ANDA ANDA074787 NCS HealthCare of KY, Inc dba Vangard Labs LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-7689_91a26576-340e-4699-856f-42510bcb2b1d 0615-7689 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20101223 ANDA ANDA075022 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 15 mg/1 0615-7690_495dfca9-c3e6-4efe-a30a-e99906e735a2 0615-7690 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 NCS HealthCare of KY, Inc dba Vangard Labs LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-7691_32150874-4c83-4ce9-a4ad-f26ce6549e42 0615-7691 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20100118 ANDA ANDA076698 NCS HealthCare of KY, Inc dba Vangard Labs METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0615-7692_32150874-4c83-4ce9-a4ad-f26ce6549e42 0615-7692 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20100118 ANDA ANDA076698 NCS HealthCare of KY, Inc dba Vangard Labs METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0615-7693_eede9a6a-6d1b-451c-8d84-eb49b01aae36 0615-7693 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070033 NCS HealthCare of KY, Inc dba Vangard Labs METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0615-7694_f6024e84-2af1-4ad1-bcc7-f8c5d51c652f 0615-7694 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20101025 NDA AUTHORIZED GENERIC NDA018238 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0615-7695_cb572295-e78c-40b8-8a9b-d5d1b36e7b07 0615-7695 HUMAN OTC DRUG Fexofenodine Hydrochloride Fexofenadine TABLET, FILM COATED ORAL 20110808 ANDA ANDA076447 NCS HealthCare of KY, Inc dba Vangard Labs FEXOFENADINE HYDROCHLORIDE 60 mg/1 0615-7696_c556a3da-dd66-4f9c-9514-98c68e2d6e75 0615-7696 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine TABLET, FILM COATED ORAL 20110422 ANDA ANDA076447 NCS HealthCare of KY, Inc dba Vangard Labs FEXOFENADINE HYDROCHLORIDE 180 mg/1 0615-7698_3eaec610-2370-43c9-9c4d-d1a077906fe8 0615-7698 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20111118 ANDA ANDA072801 NCS HealthCare of KY, Inc dba Vangard Labs METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0615-7704_3bcdc61c-5b00-4537-948a-084d106a6b6e 0615-7704 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-7705_3bcdc61c-5b00-4537-948a-084d106a6b6e 0615-7705 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-7706_3bcdc61c-5b00-4537-948a-084d106a6b6e 0615-7706 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-7707_3bcdc61c-5b00-4537-948a-084d106a6b6e 0615-7707 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20120614 ANDA ANDA077691 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-7708_3bcdc61c-5b00-4537-948a-084d106a6b6e 0615-7708 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-7709_06ca0dcb-5a5c-4104-b38f-b964fbcca08c 0615-7709 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110718 ANDA ANDA074201 NCS HealthCare of KY, Inc dba Vangard Labs NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0615-7713_de2d67e7-bf27-4764-bbc6-aef1db4f7ea2 0615-7713 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20120323 ANDA ANDA077027 NCS HealthCare of KY, Inc dba Vangard Labs CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0615-7714_91a26576-340e-4699-856f-42510bcb2b1d 0615-7714 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20120423 ANDA ANDA075022 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 5 mg/1 0615-7716_84fd20f2-c938-45d9-8550-20c350d3f631 0615-7716 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20120626 ANDA ANDA077027 NCS HealthCare of KY, Inc dba Vangard Labs CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0615-7717_553514ae-c2af-4c46-b6b3-2aa285a646f7 0615-7717 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084114 NCS HealthCare of KY, Inc dba Vangard Labs CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0615-7718_91a26576-340e-4699-856f-42510bcb2b1d 0615-7718 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020228 ANDA ANDA075022 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 10 mg/1 0615-7719_92b79d13-3123-4fa0-a9d8-c0ae31b8df94 0615-7719 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA076999 NCS HealthCare of KY, Inc dba Vangard Labs CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 0615-7721_93920266-0b69-41a5-a9b0-b2a0a9cca2c7 0615-7721 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 NCS HealthCare of KY, Inc dba Vangard Labs ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-7722_93920266-0b69-41a5-a9b0-b2a0a9cca2c7 0615-7722 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 NCS HealthCare of KY, Inc dba Vangard Labs ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-7724_fcb755f3-3f6b-42c8-999e-c412fa166b9c 0615-7724 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 NCS HealthCare of KY, Inc dba Vangard Labs QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 0615-7725_fcb755f3-3f6b-42c8-999e-c412fa166b9c 0615-7725 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 NCS HealthCare of KY, Inc dba Vangard Labs QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 0615-7729_6a0b6ef4-ba1d-4f1a-8620-94ac85e48179 0615-7729 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20020726 ANDA ANDA076268 NCS HealthCare of KY, Inc dba Vangard Labs DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0615-7730_6a0b6ef4-ba1d-4f1a-8620-94ac85e48179 0615-7730 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20020726 ANDA ANDA076268 NCS HealthCare of KY, Inc dba Vangard Labs DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0615-7738_4bd1672f-54df-4a23-a7cd-dd63d302abdc 0615-7738 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 19781201 ANDA ANDA084903 NCS HealthCare of KY, Inc dba Vangard Labs PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-7740_1978b2f3-3a16-42fa-9837-ab786ea267b1 0615-7740 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20080929 ANDA ANDA077793 NCS HealthCare of KY, Inc dba Vangard Labs PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0615-7747_84fd20f2-c938-45d9-8550-20c350d3f631 0615-7747 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20120323 ANDA ANDA077027 NCS HealthCare of KY, Inc dba Vangard Labs CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0615-7748_508c39f3-66a8-4db2-b1ec-87533ab2ca03 0615-7748 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA078605 NCS HealthCare of KY, Inc dba Vangard Labs MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0615-7749_fc028060-53ef-4b79-8767-8a446e53a066 0615-7749 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0615-7750_fc028060-53ef-4b79-8767-8a446e53a066 0615-7750 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0615-7751_fc028060-53ef-4b79-8767-8a446e53a066 0615-7751 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0615-7752_e3f3de04-1c4f-4af6-836d-06cbebc6b63c 0615-7752 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19851017 ANDA ANDA070581 NCS HealthCare of KY, Inc dba Vangard Labs METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0615-7753_fc028060-53ef-4b79-8767-8a446e53a066 0615-7753 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0615-7754_57bc249e-bc84-43d0-a294-4fd8f55f2c2d 0615-7754 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 NCS HealthCare of KY, Inc dba Vangard Labs DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0615-7755_1b09fce6-6835-48ad-a2d3-aae80b549579 0615-7755 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19860730 ANDA ANDA085223 NCS HealthCare of KY, Inc dba Vangard Labs DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0615-7756_f6d7be3e-a108-4617-8864-352d233e85b0 0615-7756 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100811 ANDA ANDA090598 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0615-7757_f6d7be3e-a108-4617-8864-352d233e85b0 0615-7757 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100811 ANDA ANDA090598 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0615-7761_767c21f7-8cfc-42fa-8426-8baa18752ab1 0615-7761 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 ANDA ANDA071972 NCS HealthCare of KY, Inc dba Vangard Labs PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-7762_3f9d516c-c418-46d6-a229-550abfc9efec 0615-7762 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-7767_f8254d44-b47a-4e83-bbb9-c99f6fc3ce52 0615-7767 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200270 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0615-7768_f8254d44-b47a-4e83-bbb9-c99f6fc3ce52 0615-7768 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200495 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0615-7773_7769018d-0184-4e86-b09b-e7ae38addfe5 0615-7773 HUMAN OTC DRUG SENEXON-S docusate sodium-sennosides tablet TABLET, COATED ORAL 20060209 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 0615-7774_47ba799b-8499-4473-b430-650c6ff5ec05 0615-7774 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-7775_13d08320-0834-49ea-9a57-e4cf5b8b0433 0615-7775 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-7776_47ba799b-8499-4473-b430-650c6ff5ec05 0615-7776 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-7777_47ba799b-8499-4473-b430-650c6ff5ec05 0615-7777 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-7778_4be2e25b-e1f2-4a4c-8914-72981474b736 0615-7778 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-7779_47ba799b-8499-4473-b430-650c6ff5ec05 0615-7779 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0615-7814_cef1cb71-78ce-424e-a1e4-82d60474a126 0615-7814 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091202 ANDA ANDA040625 NCS HealthCare of KY, Inc dba Vangard Labs FOLIC ACID 1 mg/1 0615-7823_a8d1df3e-20e7-4585-93ee-4bc3a6f4f14e 0615-7823 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-7824_a8d1df3e-20e7-4585-93ee-4bc3a6f4f14e 0615-7824 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-7825_35a8ee96-5a0f-4455-baec-840e545a75ab 0615-7825 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA078889 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0615-7830_7353a8af-3bcd-4ecb-9b66-22521aa6a29d 0615-7830 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 NCS HealthCare of KY, Inc dba Vangard Labs CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-7831_7353a8af-3bcd-4ecb-9b66-22521aa6a29d 0615-7831 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 NCS HealthCare of KY, Inc dba Vangard Labs CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-7832_7353a8af-3bcd-4ecb-9b66-22521aa6a29d 0615-7832 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 NCS HealthCare of KY, Inc dba Vangard Labs CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0615-7839_b545139e-f46d-4b9b-9f72-8798132c5255 0615-7839 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140317 ANDA ANDA075350 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-7840_0f5cd26d-1274-444a-bdfd-eb8f7476d1f1 0615-7840 HUMAN PRESCRIPTION DRUG Valproic Valproic Acid CAPSULE, LIQUID FILLED ORAL 20090908 ANDA ANDA073229 NCS HealthCare of KY, Inc dba Vangard Labs VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0615-7842_36182a4d-c78e-4ec7-be58-c14cefb23827 0615-7842 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 NCS HealthCare of KY, Inc dba Vangard Labs DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0615-7843_36182a4d-c78e-4ec7-be58-c14cefb23827 0615-7843 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET ORAL 20110528 ANDA ANDA090686 NCS HealthCare of KY, Inc dba Vangard Labs DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0615-7844_b545139e-f46d-4b9b-9f72-8798132c5255 0615-7844 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140317 ANDA ANDA075350 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-7845_b545139e-f46d-4b9b-9f72-8798132c5255 0615-7845 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0615-7846_fcb755f3-3f6b-42c8-999e-c412fa166b9c 0615-7846 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20130717 ANDA ANDA077745 NCS HealthCare of KY, Inc dba Vangard Labs QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 0615-7847_64e767dc-f4a7-42c7-83f3-4be9aef2dca9 0615-7847 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0615-7848_9067fac0-325f-4bf4-9dca-4624abb9c437 0615-7848 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20100306 ANDA ANDA077100 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0615-7860_ff991d00-b2c8-4957-afdb-e4ede4d35f1e 0615-7860 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20140627 ANDA ANDA087479 NCS HealthCare of KY, Inc dba Vangard Labs HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0615-7861_156d3bb4-e65d-4020-b3a6-42558bc077ff 0615-7861 HUMAN PRESCRIPTION DRUG KLOR-CON M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20140901 ANDA ANDA074726 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0615-7862_156d3bb4-e65d-4020-b3a6-42558bc077ff 0615-7862 HUMAN PRESCRIPTION DRUG KLOR-CON M potassium chloride TABLET, EXTENDED RELEASE ORAL 20140901 ANDA ANDA074726 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0641-0121_5995b5b5-abb9-4d8b-ae0c-d7ff7888ee9e 0641-0121 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19720101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-0367_31a81000-5a83-4220-a919-9aac527ff617 0641-0367 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION INTRAMUSCULAR; INTRAVENOUS 19820907 ANDA ANDA087702 West-Ward Pharmaceutical Corp. DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0641-0376_be14178b-bc59-44f5-b793-45bac461eb4c 0641-0376 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19721127 ANDA ANDA080817 West-ward Pharmaceutical Corp. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0641-0391_598491a0-a026-4212-babf-3fbb4230ca38 0641-0391 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19720322 NDA NDA017037 West-ward Pharmaceutical Corp. HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0641-0400_598491a0-a026-4212-babf-3fbb4230ca38 0641-0400 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19720322 NDA NDA017037 West-ward Pharmaceutical Corp. HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0641-0410_598491a0-a026-4212-babf-3fbb4230ca38 0641-0410 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19720322 NDA NDA017037 West-ward Pharmaceutical Corp. HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0641-0476_78aecf93-f2bf-4179-a68c-8f25be4d1d4c 0641-0476 HUMAN PRESCRIPTION DRUG Phenobarbital Sodium Phenobarbital Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19710101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. PHENOBARBITAL SODIUM 65 mg/mL CIV 0641-0477_78aecf93-f2bf-4179-a68c-8f25be4d1d4c 0641-0477 HUMAN PRESCRIPTION DRUG Phenobarbital Sodium Phenobarbital Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19710101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. PHENOBARBITAL SODIUM 130 mg/mL CIV 0641-0491_7b251584-d98e-459b-9a71-8574bd5733d1 0641-0491 HUMAN PRESCRIPTION DRUG Prochlorperazine Edisylate Prochlorperazine Edisylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20110114 ANDA ANDA089903 Baxter Healthcare Corporation PROCHLORPERAZINE EDISYLATE 5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0641-0493_ed4d0d64-ad83-4947-9ede-ecb53b7a2d7d 0641-0493 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19750716 ANDA ANDA084307 West-Ward Pharmaceutical Corp. PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0641-0495_a93ac7a5-5d60-4c8f-b0d9-85ac46f066ef 0641-0495 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19710101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. SODIUM CHLORIDE 9 mg/mL 0641-0497_4c63b789-7945-4b48-9794-8c4840a9d957 0641-0497 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20130924 ANDA ANDA201833 West-Ward Pharmaceutical Corp. SODIUM CHLORIDE 9 mg/mL 0641-0928_d224d3b9-d5c2-40a7-8e1b-333a5362ba01 0641-0928 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0641-0929_d224d3b9-d5c2-40a7-8e1b-333a5362ba01 0641-0929 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0641-0948_fe649048-d0d1-448a-8c52-0aff4f672d19 0641-0948 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0641-0949_fe649048-d0d1-448a-8c52-0aff4f672d19 0641-0949 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0641-0955_2cd5722b-7cf2-4460-bcb7-50221dec5372 0641-0955 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0641-0956_2cd5722b-7cf2-4460-bcb7-50221dec5372 0641-0956 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0641-1397_7b96d3c9-fabd-4e52-a277-63f124222814 0641-1397 HUMAN PRESCRIPTION DRUG Chlorpromazine hydrochloride Chlorpromazine hydrochloride INJECTION INTRAMUSCULAR 19740725 ANDA ANDA083329 West-ward Pharmaceutical Corp. CHLORPROMAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0641-1398_7b96d3c9-fabd-4e52-a277-63f124222814 0641-1398 HUMAN PRESCRIPTION DRUG Chlorpromazine hydrochloride Chlorpromazine hydrochloride INJECTION INTRAMUSCULAR 19740725 ANDA ANDA083329 West-ward Pharmaceutical Corp. CHLORPROMAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0641-1410_75f8fa0b-0bb0-4141-861c-3c54f9920d65 0641-1410 HUMAN PRESCRIPTION DRUG Digoxin Digoxin INJECTION INTRAMUSCULAR; INTRAVENOUS 19751024 ANDA ANDA083391 West-Ward Pharmaceutical Corp. DIGOXIN .25 mg/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0641-1495_f9a92eee-c65d-461e-94b9-ac19c6529854 0641-1495 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0641-1496_f9a92eee-c65d-461e-94b9-ac19c6529854 0641-1496 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0641-1512_87112666-5d03-4e58-996e-bd2eecf8d5d7 0641-1512 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20120120 ANDA ANDA201850 West-ward Pharmaceutical Corp. SODIUM CHLORIDE 9 mg/mL 0641-2341_5995b5b5-abb9-4d8b-ae0c-d7ff7888ee9e 0641-2341 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19720101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-2450_598491a0-a026-4212-babf-3fbb4230ca38 0641-2450 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19720322 NDA NDA017037 West-ward Pharmaceutical Corp. HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0641-2460_598491a0-a026-4212-babf-3fbb4230ca38 0641-2460 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19720322 NDA NDA017037 West-ward Pharmaceutical Corp. HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 0641-2555_ed4d0d64-ad83-4947-9ede-ecb53b7a2d7d 0641-2555 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19750716 ANDA ANDA084307 West-Ward Pharmaceutical Corp. PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0641-2569_2d18d851-d842-476c-b1c4-8b1b332e6c76 0641-2569 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole INJECTION INTRAVENOUS 19961018 ANDA ANDA074521 West-ward Pharmaceutical Corp. DIPYRIDAMOLE 5 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0641-2965_9adad150-da57-4281-bfab-7780c25f26a6 0641-2965 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride ESMOLOL HYDROCHLORIDE INJECTION INTRAVENOUS 19861231 NDA NDA019386 West Ward Pharmaceutical Corporation ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0641-6000_7d4cd6c3-18f9-4e26-83a8-8e54e0a6fb2a 0641-6000 HUMAN PRESCRIPTION DRUG Ativan Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-ward Pharmaceutical Corp. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6001_7d4cd6c3-18f9-4e26-83a8-8e54e0a6fb2a 0641-6001 HUMAN PRESCRIPTION DRUG Ativan Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-ward Pharmaceutical Corp. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6002_7d4cd6c3-18f9-4e26-83a8-8e54e0a6fb2a 0641-6002 HUMAN PRESCRIPTION DRUG Ativan Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-ward Pharmaceutical Corp. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6003_7d4cd6c3-18f9-4e26-83a8-8e54e0a6fb2a 0641-6003 HUMAN PRESCRIPTION DRUG Ativan Lorazeapm INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-ward Pharmaceutical Corp. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6006_b5db2b41-ad60-4a44-927c-c260e56c4cdc 0641-6006 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19710101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. ATROPINE SULFATE .4 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0641-6007_ec8f38ae-3812-4540-aac6-b2df8f528f5d 0641-6007 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide INJECTION INTRAMUSCULAR; INTRAVENOUS 20080430 ANDA ANDA079196 West-ward Pharmaceutical Corp. BUMETANIDE .25 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0641-6008_ec8f38ae-3812-4540-aac6-b2df8f528f5d 0641-6008 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide INJECTION INTRAMUSCULAR; INTRAVENOUS 20080430 ANDA ANDA079196 West-ward Pharmaceutical Corp. BUMETANIDE .25 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0641-6013_832970c9-88cb-4694-9e32-380135b9f5c8 0641-6013 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION INTRAVENOUS 20081217 ANDA ANDA078538 West-ward Pharmaceutical Corp. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0641-6014_832970c9-88cb-4694-9e32-380135b9f5c8 0641-6014 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION INTRAVENOUS 20081217 ANDA ANDA078538 West-ward Pharmaceutical Corp. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0641-6015_832970c9-88cb-4694-9e32-380135b9f5c8 0641-6015 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION INTRAVENOUS 20081217 ANDA ANDA078538 West-ward Pharmaceutical Corp. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0641-6018_7c74602f-5167-4f3d-8912-f6016b2eb99e 0641-6018 HUMAN PRESCRIPTION DRUG Dopram Doxapram hydrochloride INJECTION INTRAVENOUS 19650623 NDA NDA014879 West-ward Pharmaceutical Corp. DOXAPRAM HYDROCHLORIDE 20 mg/mL Increased Medullary Respiratory Drive [PE],Respiratory Stimulant [EPC] 0641-6019_bcdd3ec9-7474-4798-8e25-f308a5abbeba 0641-6019 HUMAN PRESCRIPTION DRUG Duramorph morphine sulfate INJECTION EPIDURAL; INTRATHECAL; INTRAVENOUS 19840918 NDA NDA018565 West-Ward Pharmaceutical Corp. MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6020_bcdd3ec9-7474-4798-8e25-f308a5abbeba 0641-6020 HUMAN PRESCRIPTION DRUG Duramorph morphine sulfate INJECTION EPIDURAL; INTRATHECAL; INTRAVENOUS 19840918 NDA NDA018565 West-Ward Pharmaceutical Corp. MORPHINE SULFATE .5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6021_08840114-5001-4779-9471-1957a73d7961 0641-6021 HUMAN PRESCRIPTION DRUG Famotidine Famotidine INJECTION INTRAVENOUS 20010416 ANDA ANDA075488 West-ward Pharmaceutical Corp. FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0641-6022_08840114-5001-4779-9471-1957a73d7961 0641-6022 HUMAN PRESCRIPTION DRUG Famotidine Famotidine INJECTION INTRAVENOUS 20010416 ANDA ANDA075486 West-ward Pharmaceutical Corp. FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0641-6023_08840114-5001-4779-9471-1957a73d7961 0641-6023 HUMAN PRESCRIPTION DRUG Famotidine Famotidine INJECTION INTRAVENOUS 20010416 ANDA ANDA075488 West-ward Pharmaceutical Corp. FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0641-6024_8eaf8c56-317b-4b53-91ab-5564d2fd88b3 0641-6024 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION INTRAMUSCULAR; INTRAVENOUS 19840711 ANDA ANDA019101 West-ward Pharmaceutical Corp. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6025_8eaf8c56-317b-4b53-91ab-5564d2fd88b3 0641-6025 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION INTRAMUSCULAR; INTRAVENOUS 19840711 ANDA ANDA019101 West-ward Pharmaceutical Corp. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6026_8eaf8c56-317b-4b53-91ab-5564d2fd88b3 0641-6026 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION INTRAVENOUS 19840711 ANDA ANDA019101 West-ward Pharmaceutical Corp. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6027_8eaf8c56-317b-4b53-91ab-5564d2fd88b3 0641-6027 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION INTRAMUSCULAR; INTRAVENOUS 19840711 ANDA ANDA019101 West-ward Pharmaceutical Corp. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6028_8eaf8c56-317b-4b53-91ab-5564d2fd88b3 0641-6028 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION INTRAMUSCULAR; INTRAVENOUS 19840711 ANDA ANDA019101 West-ward Pharmaceutical Corp. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6029_8eaf8c56-317b-4b53-91ab-5564d2fd88b3 0641-6029 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION INTRAVENOUS 19840711 ANDA ANDA019101 West-ward Pharmaceutical Corp. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6030_8eaf8c56-317b-4b53-91ab-5564d2fd88b3 0641-6030 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION INTRAVENOUS 19840711 ANDA ANDA019101 West-ward Pharmaceutical Corp. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6031_d441809f-34f5-4ad8-ad17-9f224aa329ff 0641-6031 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION INTRAVENOUS 20041012 ANDA ANDA076787 West-ward Pharmaceutical Corp. FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 0641-6032_d441809f-34f5-4ad8-ad17-9f224aa329ff 0641-6032 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION INTRAVENOUS 20041012 ANDA ANDA076787 West-ward Pharmaceutical Corp. FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 0641-6033_d2cb6514-ba29-4b95-b9a1-6cd21a5e2371 0641-6033 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 West-ward Pharmaceutical Corp. GLYCOPYRROLATE .2 mg/mL 0641-6034_d2cb6514-ba29-4b95-b9a1-6cd21a5e2371 0641-6034 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 West-ward Pharmaceutical Corp. GLYCOPYRROLATE .2 mg/mL 0641-6035_d2cb6514-ba29-4b95-b9a1-6cd21a5e2371 0641-6035 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 West-ward Pharmaceutical Corp. GLYCOPYRROLATE .2 mg/mL 0641-6036_d2cb6514-ba29-4b95-b9a1-6cd21a5e2371 0641-6036 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 West-ward Pharmaceutical Corp. GLYCOPYRROLATE .2 mg/mL 0641-6039_bf2d26e9-484c-4fdc-9188-3c3c3cad0f2a 0641-6039 HUMAN PRESCRIPTION DRUG INFUMORPH 200 morphine sulfate INJECTION, SOLUTION EPIDURAL; INTRATHECAL 19840918 NDA NDA018565 West-ward Pharmaceutical Corp. MORPHINE SULFATE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6040_bf2d26e9-484c-4fdc-9188-3c3c3cad0f2a 0641-6040 HUMAN PRESCRIPTION DRUG INFUMORPH 500 morphine sulfate INJECTION, SOLUTION EPIDURAL; INTRATHECAL 19840918 NDA NDA018565 West-ward Pharmaceutical Corp. MORPHINE SULFATE 25 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6041_5c5b8f69-c332-49e3-8175-8f3fc1266c87 0641-6041 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION INTRAMUSCULAR; INTRAVENOUS 20040721 ANDA ANDA075772 West-ward Pharmaceutical Corp. KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0641-6042_5c5b8f69-c332-49e3-8175-8f3fc1266c87 0641-6042 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION INTRAMUSCULAR; INTRAVENOUS 20040721 ANDA ANDA075772 West-ward Pharmaceutical Corp. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0641-6043_5c5b8f69-c332-49e3-8175-8f3fc1266c87 0641-6043 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION INTRAMUSCULAR 20040721 ANDA ANDA075772 West-ward Pharmaceutical Corp. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0641-6044_cde45935-598e-4eb9-8235-fb412a97a945 0641-6044 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-ward Pharmaceutical Corp. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6045_cde45935-598e-4eb9-8235-fb412a97a945 0641-6045 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-ward Pharmaceutical Corp. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6046_cde45935-598e-4eb9-8235-fb412a97a945 0641-6046 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-ward Pharmaceutical Corp. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6047_cde45935-598e-4eb9-8235-fb412a97a945 0641-6047 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-ward Pharmaceutical Corp. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6048_1837418f-d456-483b-b9c7-bc74989d7c2b 0641-6048 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-ward Pharmaceutical Corp. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6049_1837418f-d456-483b-b9c7-bc74989d7c2b 0641-6049 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-ward Pharmaceutical Corp. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6050_1837418f-d456-483b-b9c7-bc74989d7c2b 0641-6050 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-ward Pharmaceutical Corp. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6051_1837418f-d456-483b-b9c7-bc74989d7c2b 0641-6051 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-ward Pharmaceutical Corp. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6052_d88c088a-4e6b-4a75-a2d7-99babc5ce32b 0641-6052 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19750122 ANDA ANDA080445 West-ward Pharmaceutical Corp. MEPERIDINE HYDROCHLORIDE 25 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6053_d88c088a-4e6b-4a75-a2d7-99babc5ce32b 0641-6053 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19750122 ANDA ANDA080445 West-ward Pharmaceutical Corp. MEPERIDINE HYDROCHLORIDE 50 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6054_d88c088a-4e6b-4a75-a2d7-99babc5ce32b 0641-6054 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19750122 ANDA ANDA080445 West-ward Pharmaceutical Corp. MEPERIDINE HYDROCHLORIDE 100 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6056_3f95a5d2-da29-42da-9c3e-62a42b1f8395 0641-6056 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 West-ward Pharmaceutical Corp. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6057_3f95a5d2-da29-42da-9c3e-62a42b1f8395 0641-6057 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 West-ward Pharmaceutical Corp. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6059_3f95a5d2-da29-42da-9c3e-62a42b1f8395 0641-6059 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 West-ward Pharmaceutical Corp. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6060_3f95a5d2-da29-42da-9c3e-62a42b1f8395 0641-6060 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 West-ward Pharmaceutical Corp. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6061_3f95a5d2-da29-42da-9c3e-62a42b1f8395 0641-6061 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 West-ward Pharmaceutical Corp. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6063_3f95a5d2-da29-42da-9c3e-62a42b1f8395 0641-6063 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 West-ward Pharmaceutical Corp. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0641-6065_7fdfbdfe-52fe-48c5-a44a-a4f09cd415ea 0641-6065 HUMAN PRESCRIPTION DRUG Milrinone Lactate Milrinone Lactate INJECTION INTRAVENOUS 20020528 ANDA ANDA075530 West-ward Pharmaceutical Corp. MILRINONE LACTATE 1 mg/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0641-6067_7fdfbdfe-52fe-48c5-a44a-a4f09cd415ea 0641-6067 HUMAN PRESCRIPTION DRUG Milrinone Lactate Milrinone Lactate INJECTION INTRAVENOUS 20020528 ANDA ANDA075530 West-ward Pharmaceutical Corp. MILRINONE LACTATE 1 mg/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 0641-6068_237bbab5-740b-4031-b004-e72a6689ee60 0641-6068 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19710101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. MORPHINE SULFATE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6070_237bbab5-740b-4031-b004-e72a6689ee60 0641-6070 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19710101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. MORPHINE SULFATE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6071_237bbab5-740b-4031-b004-e72a6689ee60 0641-6071 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19710101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. MORPHINE SULFATE 15 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6072_237bbab5-740b-4031-b004-e72a6689ee60 0641-6072 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19710101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. MORPHINE SULFATE 15 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6073_237bbab5-740b-4031-b004-e72a6689ee60 0641-6073 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19710101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. MORPHINE SULFATE 5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6075_237bbab5-740b-4031-b004-e72a6689ee60 0641-6075 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19710101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. MORPHINE SULFATE 8 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6076_a234ae86-733f-4024-97d3-73b9603efab5 0641-6076 HUMAN PRESCRIPTION DRUG Neostigmine Methylsulfate Neostigmine Methylsulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19730101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. NEOSTIGMINE METHYLSULFATE .5 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0641-6077_a234ae86-733f-4024-97d3-73b9603efab5 0641-6077 HUMAN PRESCRIPTION DRUG Neostigmine Methylsulfate Neostigmine Methylsulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19730101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. NEOSTIGMINE METHYLSULFATE 1 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0641-6078_638f2a9b-d501-4808-860c-ac98d94405cf 0641-6078 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077541 West-Ward Pharmaceutical Corp. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0641-6079_638f2a9b-d501-4808-860c-ac98d94405cf 0641-6079 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077365 West-Ward Pharmaceutical Corp. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0641-6080_82b052da-b4e0-472c-abcf-48a70fe123f7 0641-6080 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077541 West-Ward Pharmaceutical Corp. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0641-6082_1cee9794-5b56-4d41-a27e-86ba9cbf831d 0641-6082 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0641-6083_1cee9794-5b56-4d41-a27e-86ba9cbf831d 0641-6083 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride INJECTION INTRAMUSCULAR 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0641-6084_d04e641a-8b8a-4756-9946-3a2664f66562 0641-6084 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0641-6085_d04e641a-8b8a-4756-9946-3a2664f66562 0641-6085 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride INJECTION INTRAMUSCULAR 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0641-6088_c02b5c21-0b5d-4140-80f7-20d431fab361 0641-6088 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19890101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 0641-6099_42359b1f-53f4-499c-871f-1c0485d56d2c 0641-6099 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0641-6103_ec4bece0-53e5-4425-97f5-8fbda26a3a9f 0641-6103 HUMAN PRESCRIPTION DRUG ROBAXIN methocarbamol INJECTION INTRAMUSCULAR; INTRAVENOUS 19590616 NDA NDA011790 West-ward Pharmaceutical Corp. METHOCARBAMOL 100 mg/mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0641-6104_49eae418-a8a9-488a-a8ec-3c9d8eb9f303 0641-6104 HUMAN PRESCRIPTION DRUG Robinul Robinul INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 West-ward Pharmaceutical Corp. GLYCOPYRROLATE .2 mg/mL 0641-6105_49eae418-a8a9-488a-a8ec-3c9d8eb9f303 0641-6105 HUMAN PRESCRIPTION DRUG Robinul Robinul INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 West-ward Pharmaceutical Corp. GLYCOPYRROLATE .2 mg/mL 0641-6106_49eae418-a8a9-488a-a8ec-3c9d8eb9f303 0641-6106 HUMAN PRESCRIPTION DRUG Robinul Robinul INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 West-ward Pharmaceutical Corp. GLYCOPYRROLATE .2 mg/mL 0641-6107_49eae418-a8a9-488a-a8ec-3c9d8eb9f303 0641-6107 HUMAN PRESCRIPTION DRUG Robinul Robinul INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 West-ward Pharmaceutical Corp. GLYCOPYRROLATE .2 mg/mL 0641-6110_665e04c2-df92-4967-a8d9-0717eaf9d279 0641-6110 HUMAN PRESCRIPTION DRUG Sufentanil Citrate Sufentanil Citrate INJECTION EPIDURAL; INTRAVENOUS 19951215 ANDA ANDA074413 West-ward Pharmaceutical Corp. SUFENTANIL CITRATE .05 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6111_665e04c2-df92-4967-a8d9-0717eaf9d279 0641-6111 HUMAN PRESCRIPTION DRUG Sufentanil Citrate Sufentanil Citrate INJECTION EPIDURAL; INTRAVENOUS 19951215 ANDA ANDA074413 West-ward Pharmaceutical Corp. SUFENTANIL CITRATE .05 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6112_665e04c2-df92-4967-a8d9-0717eaf9d279 0641-6112 HUMAN PRESCRIPTION DRUG Sufentanil Citrate Sufentanil Citrate INJECTION EPIDURAL; INTRAVENOUS 19951215 ANDA ANDA074413 West-ward Pharmaceutical Corp. SUFENTANIL CITRATE .05 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0641-6113_b1d995ba-93ec-4d06-b459-9545f2a1b3f6 0641-6113 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION INTRAVENOUS 20040616 ANDA ANDA076500 West-ward Pharmaceutical Corp. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 0641-6114_58b5f701-ca81-4dad-8f1e-33caf7d5ebf9 0641-6114 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION INTRAMUSCULAR; INTRAVENOUS 19800429 NDA NDA018243 West-Ward Pharmaceutical Corp. OXYTOCIN 10 [USP'U]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 0641-6115_58b5f701-ca81-4dad-8f1e-33caf7d5ebf9 0641-6115 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION INTRAMUSCULAR; INTRAVENOUS 19800429 NDA NDA018243 West-Ward Pharmaceutical Corp. OXYTOCIN 10 [USP'U]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 0641-6116_dba9b466-303f-4d0c-8a7f-3c81ab836cac 0641-6116 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091222 ANDA ANDA065406 West-Ward Pharmaceutical Corp. AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1.5g; g/1.5g Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0641-6117_dba9b466-303f-4d0c-8a7f-3c81ab836cac 0641-6117 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091222 ANDA ANDA065406 West-Ward Pharmaceutical Corp. AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/3g; g/3g Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0641-6118_2ec789f7-d2b6-493c-81e5-1ef96acb2a97 0641-6118 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091203 ANDA ANDA065403 West-Ward Pharmaceutical Corp. AMPICILLIN SODIUM; SULBACTAM SODIUM 100; 50 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0641-6119_6c40dc4f-f897-4184-9a05-5ff4562cc69e 0641-6119 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091222 ANDA ANDA065406 West-Ward Pharmaceutical Corp. AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1.5g; g/1.5g Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0641-6120_6c40dc4f-f897-4184-9a05-5ff4562cc69e 0641-6120 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091222 ANDA ANDA065406 West-Ward Pharmaceutical Corp. AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/3g; g/3g Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0641-6121_5df45463-20c6-434a-99f1-b5592e0789bc 0641-6121 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091203 ANDA ANDA065403 West-Ward Pharmaceutical Corp. AMPICILLIN SODIUM; SULBACTAM SODIUM 100; 50 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0641-6122_d04b9c2b-a783-4713-ba8d-8bbc513499a8 0641-6122 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091222 ANDA ANDA065406 West-ward Pharmaceutical Corp. AMPICILLIN SODIUM; SULBACTAM SODIUM 250; 125 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0641-6123_d04b9c2b-a783-4713-ba8d-8bbc513499a8 0641-6123 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091222 ANDA ANDA065406 West-ward Pharmaceutical Corp. AMPICILLIN SODIUM; SULBACTAM SODIUM 250; 125 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0641-6136_71222254-fb8d-44eb-a6e0-d4a27c30954c 0641-6136 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 20070806 ANDA ANDA077989 West-Ward Pharmaceutical Corp. FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0641-6137_71222254-fb8d-44eb-a6e0-d4a27c30954c 0641-6137 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 20070806 ANDA ANDA077989 West-Ward Pharmaceutical Corp. FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0641-6138_6281adbe-9bf9-4da8-96ba-abdc52e96250 0641-6138 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19750716 ANDA ANDA084307 West-Ward Pharmaceutical Corp. PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0641-6139_6281adbe-9bf9-4da8-96ba-abdc52e96250 0641-6139 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19750716 ANDA ANDA084307 West-Ward Pharmaceutical Corp. PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0641-6140_8d4d4e0f-8298-4dfd-b3ad-31cc7f97a409 0641-6140 HUMAN PRESCRIPTION DRUG Neostigmine Methylsulfate Neostigmine Methylsulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19730101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. NEOSTIGMINE METHYLSULFATE 1 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0641-6141_8d4d4e0f-8298-4dfd-b3ad-31cc7f97a409 0641-6141 HUMAN PRESCRIPTION DRUG Neostigmine Methylsulfate Neostigmine Methylsulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19730101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. NEOSTIGMINE METHYLSULFATE .5 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0641-6142_1b182a73-a7a5-46d5-ab15-d960db190445 0641-6142 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride INJECTION INTRAVENOUS 20121218 NDA NDA203826 West-Ward Pharmaceutical Corp. PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 0641-6143_4c63b789-7945-4b48-9794-8c4840a9d957 0641-6143 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20130924 ANDA ANDA201833 West-Ward Pharmaceutical Corp. SODIUM CHLORIDE 9 mg/mL 0641-6154_c65184c7-48fb-41f7-aee9-aa431715403b 0641-6154 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol INJECTION INTRAVENOUS 20130830 ANDA ANDA091101 West-Ward Pharmaceutical Corp. DOXERCALCIFEROL 2 ug/mL Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] 0642-0070_e6535f53-9b25-48ed-817f-9dc637598612 0642-0070 HUMAN PRESCRIPTION DRUG Vitafol One Prenatal Supplement with DHA CAPSULE, GELATIN COATED ORAL 20110613 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. ASCORBIC ACID; COPPER; CYANOCOBALAMIN; FOLIC ACID; IODINE; IRON; MAGNESIUM; NIACIN; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D; VITAMIN E; ZINC 30; 2; .012; 1; .15; 29; 20; 15; 200; 2.5; 1.8; 1.6; 1100; 1000; 20; 25 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; [iU]/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0642-0072_667440e5-a115-41f7-91a7-8acf0edc115f 0642-0072 HUMAN PRESCRIPTION DRUG Vitafol Caplet Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, and Iron CAPSULE ORAL 19850501 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. .ALPHA.-TOCOPHEROL; ASCORBIC ACID; CALCIUM; CYANOCOBALAMIN; FOLIC ACID; IRON; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D 10; 60; 125; 5; 1; 27; 15; 15; 1.8; 1.1; 6000; 400 [iU]/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 0642-0075_c3647888-4a04-459b-80cf-4f6b367a2945 0642-0075 HUMAN PRESCRIPTION DRUG Select-OB Plus DHA Prenatal Supplement Plus DHA .BETA.-CAROTENE, VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, Thiamine Mononitrate, Riboflavin, NIACINAMIDE, Pyridoxine Hydrochloride, Folic Acid, LEVOMEFOLATE CALCIUM, Cobalamin, Iron, MAGNESIUM OXIDE, ZINC OXIDE, and DOCONEXANT KIT 20090408 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. 0642-0076_5475e78f-94ac-4e4f-8553-7636abd4a7b5 0642-0076 HUMAN PRESCRIPTION DRUG Vitafol-OB Plus DHA Prenatal Supplement Plus DHA Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, Copper, and Doconexent KIT 20070216 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. 0642-0077_9a1a22a6-f13d-46fb-bde3-c2372feebddb 0642-0077 HUMAN PRESCRIPTION DRUG Select OB .Beta.-Carotene, VITAMIN A ACETATE, Ascorbic Acid, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, LEVOMEFOLATE CALCIUM, Cobalamin, Iron, Magnesium, and Zinc TABLET, CHEWABLE ORAL 20051004 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; COBALAMIN; FOLIC ACID; IRON; LEVOMEFOLATE CALCIUM; MAGNESIUM; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC 30; 600; 60; 400; 5; .4; 29; .6; 25; 15; 2.5; 1.8; 1.6; 1100; 15 [iU]/1; [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 0642-0079_faa59784-9b9e-4f5f-a6b4-d4ac19d255ad 0642-0079 HUMAN PRESCRIPTION DRUG Vitafol OB Caplet Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, and Copper TABLET ORAL 20021202 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. .ALPHA.-TOCOPHEROL; ASCORBIC ACID; CALCIUM; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D; ZINC 30; 70; 100; 2; 12; 1; 65; 25; 18; 2.5; 1.8; 1.6; 2700; 400; 25 [iU]/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 0642-0092_bb1edb09-09b6-48dc-9acb-1592639035e6 0642-0092 HUMAN PRESCRIPTION DRUG Vitafol Plus Omega-3 Fatty Acids, Niacin, .Alpha.-Tocopherol, Vitamin D, Lauric Acid, Vitamin A, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc, Copper, Iodine, Magnesium, and Folic Acid CAPSULE, LIQUID FILLED ORAL 20120423 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. .ALPHA.-TOCOPHEROL; ASCORBIC ACID; COPPER; CYANOCOBALAMIN; FOLIC ACID; IODINE; IRON; LAURIC ACID; MAGNESIUM; NIACIN; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D; ZINC 10; 12; 2; 12; 1; 200; 27; 60; 5; 15; 200; 2.5; 1.8; 1.6; 1100; 1000; 15 [iU]/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 0642-0093_f21b083f-894d-4201-9f7c-24eba7980878 0642-0093 HUMAN PRESCRIPTION DRUG Vitafol Ultra Doconexent, Niacinamide, .Alpha.-Tocopherol Acetate, DL-, Cholecalciferol, .Beta.-Carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, and Levomefolate Calcium CAPSULE, LIQUID FILLED ORAL 20130923 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; DOCONEXENT; FOLIC ACID; IRON; LEVOMEFOLATE CALCIUM; MAGNESIUM OXIDE; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 20; 1100; 30; 1000; 2; 12; 200; .4; 29; .6; 20; 15; 150; 2.5; 1.8; 1.6; 25 [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0642-0094_5a2ce476-27d7-421b-932b-a401f0fb9e22 0642-0094 HUMAN PRESCRIPTION DRUG Vitafol Nano CHOLECALCIFEROL, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Iron, and Iodine TABLET, COATED ORAL 20140714 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; IODINE; IRON; LEVOMEFOLATE CALCIUM; PYRIDOXINE HYDROCHLORIDE 1000; 12; .4; 150; 18; .6; 2.5 [iU]/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 0642-0120_13fcc1c1-c176-4500-937e-be35b285c7c8 0642-0120 HUMAN PRESCRIPTION DRUG Select OB .BETA.-CAROTENE, VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, COBALAMIN, IRON, MAGNESIUM OXIDE, and ZINC OXIDE TABLET, CHEWABLE ORAL 20140714 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; COBALAMIN; FOLIC ACID; IRON; LEVOMEFOLATE CALCIUM; MAGNESIUM OXIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE 30; 600; 60; 400; 5; .4; 29; .6; 25; 15; 2.5; 1.8; 1.6; 1100; 15 [iU]/1; [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0642-0204_13d4ddf2-f701-441b-87d6-010bc26f677d 0642-0204 HUMAN PRESCRIPTION DRUG Strovite Forte Caplet Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Pantothenic Acid, Magnesium, Zinc, Selenium, Copper, Chromium, Molybdenum, and Iron TABLET, COATED ORAL 19961001 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. .ALPHA.-TOCOPHEROL; ASCORBIC ACID; BIOTIN; CHROMIUM; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM; MOLYBDENUM; NIACIN; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENIUM; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D; ZINC 60; 500; .15; 50; 3; 50; 1; 10; 50; 20; 100; 25; 25; 20; 50; 20; 4000; 400; 15 [iU]/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; [iU]/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0642-0207_754ade54-910c-4419-9887-c63a63efeb47 0642-0207 HUMAN PRESCRIPTION DRUG Strovite One Caplets Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Manganese, Chromium, .Alpha.-Lipoic Acid, and Lutein TABLET ORAL 20010504 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. .ALPHA.-LIPOIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CHROMIUM; CUPRIC SULFATE; CYANOCOBALAMIN; FOLIC ACID; LUTEIN; MAGNESIUM OXIDE; MANGANESE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENIUM; THIAMINE; VITAMIN A; ZINC OXIDE 15; 100; 300; 100; 15; 1000; 50; 1.5; 50; 1; 5; 50; 1.5; 25; 25; 5; 100; 20; 3000; 25 mg/1; [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0642-3010_37359587-129b-461f-a82f-b4461eeff080 0642-3010 HUMAN PRESCRIPTION DRUG Reaphirm Plant Source DHA Prenatal Supplement CAPSULE, GELATIN COATED ORAL 20111205 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. ASCORBIC ACID; COPPER; CYANOCOBALAMIN; FOLIC ACID; IODINE; IRON; MAGNESIUM; NIACIN; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; VITAMIN D; VITAMIN E; ZINC 30; 2; .012; 1; .15; 29; 20; 15; 200; 2.5; 1.8; 1.6; 1100; 1000; 20; 25 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; [iU]/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0677-1931_1cf1a087-0e37-4cce-a080-86a535a29d4e 0677-1931 HUMAN PRESCRIPTION DRUG glycopyrrolate glycopyrrolate TABLET ORAL 20050113 NDA AUTHORIZED GENERIC NDA012827 United Research Laboratories, Inc. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0677-1932_1cf1a087-0e37-4cce-a080-86a535a29d4e 0677-1932 HUMAN PRESCRIPTION DRUG glycopyrrolate glycopyrrolate TABLET ORAL 20050113 NDA AUTHORIZED GENERIC NDA012827 United Research Laboratories, Inc. GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0677-1978_64a32a66-e695-4fa9-b0e3-df33d91ffc4f 0677-1978 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090901 NDA AUTHORIZED GENERIC NDA020356 United Research Laboratories, Inc. NISOLDIPINE 8.5 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 0677-1979_64a32a66-e695-4fa9-b0e3-df33d91ffc4f 0677-1979 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090901 NDA AUTHORIZED GENERIC NDA020356 United Research Laboratories, Inc. NISOLDIPINE 17 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 0677-1980_64a32a66-e695-4fa9-b0e3-df33d91ffc4f 0677-1980 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090901 NDA AUTHORIZED GENERIC NDA020356 United Research Laboratories, Inc. NISOLDIPINE 25.5 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 0677-1981_64a32a66-e695-4fa9-b0e3-df33d91ffc4f 0677-1981 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090901 NDA AUTHORIZED GENERIC NDA020356 United Research Laboratories, Inc. NISOLDIPINE 34 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 0682-0334_46155690-3be4-426c-bf32-45b860d2d25e 0682-0334 HUMAN PRESCRIPTION DRUG Urimar-T Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate TABLET ORAL 20050722 UNAPPROVED DRUG OTHER Marnel Pharmaceutical, Inc. HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .12; 120; 10.8; 36.2; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1 0682-0475_c30e3a34-2357-4392-bd8b-5c0cf2c6b97d 0682-0475 HUMAN OTC DRUG MAR-COF CG Expectorant CODEINE PHOSPHATE and GUAIFENESIN SYRUP ORAL 20081201 OTC MONOGRAPH FINAL part341 Marnel Pharmaceutcals, Inc. CODEINE PHOSPHATE; GUAIFENESIN 7.5; 225 mg/5mL; mg/5mL CV 0682-0480_11f3111b-84c1-4f5a-8257-d36ef7cca2c0 0682-0480 HUMAN OTC DRUG Mar-cof BP BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, and PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP ORAL 20091001 OTC MONOGRAPH FINAL part341 Marnel Pharmaceutcals, Inc. BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 7.5; 30 mg/5mL; mg/5mL; mg/5mL CV 0682-0804_827dc558-76dd-45d8-97ab-696c7f49e5d3 0682-0804 HUMAN PRESCRIPTION DRUG Margesic butalbital, acetaminophen and caffeine CAPSULE ORAL 19940601 ANDA ANDA089007 Marnel Pharmaceuticals, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0682-1570_127a3123-c560-4dc6-bebf-8a5d71f73880 0682-1570 HUMAN PRESCRIPTION DRUG Marnatal F ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, IRON SUCROSE, MAGNESIUM OXIDE, and CUPRIC OXIDE CAPSULE ORAL 20100108 UNAPPROVED DRUG OTHER Marnel Pharmaceuticals, Inc. .ALPHA.-TOCOPHEROL ACETATE, D-; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FOLIC ACID; IRON SUCROSE; MAGNESIUM OXIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE 30; 100; 150; 400; 2; 12; 1000; 60; 25; 20; 5; 3.4; 3 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0682-3001_ed775d39-46ec-4014-a727-232ab02b6f10 0682-3001 HUMAN PRESCRIPTION DRUG BACMIN VITAMIN A ACETATE, .ALPHA.-TOCOPHEROL ACETATE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, BIOTIN, CALCIUM PANTOTHENATE, FOLIC ACID, CYANOCOBALAMIN, FLAVONE, FERROUS FUMARATE, CHROMIC CHLORIDE CR-51, MAGNESIUM OXIDE, MANGANESE GLUCONATE, CUPRIC OXIDE, SELENOMETHIONINE, and ZINC OXIDE TABLET, COATED ORAL 20000401 UNAPPROVED DRUG OTHER Marnel Pharmaceuticals, Inc. .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CHROMIC CHLORIDE CR-51; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FLAVONE; FOLIC ACID; MAGNESIUM OXIDE; MANGANESE GLUCONATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENOMETHIONINE; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE 30; 500; 150; 25; .1; 3; 50; 27; 50; 1; 50; 5; 100; 25; 20; 50; 20; 2000; 22.5 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 0699-0001_b2917c26-a3fc-48a9-b5f0-1d62fe15af74 0699-0001 HUMAN PRESCRIPTION DRUG Formo Cresol Cresol LIQUID DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare CRESOL 485 mg/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC] 0699-0412_b2917c26-a3fc-48a9-b5f0-1d62fe15af74 0699-0412 HUMAN PRESCRIPTION DRUG Formo Cresol Cresol LIQUID DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare CRESOL 485 mg/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC] 0699-0957_b9b49f4f-db22-44ae-b199-be45bb33c142 0699-0957 HUMAN OTC DRUG InstaFresh Alcohol LIQUID TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part333A DSHealthcare ALCOHOL 70 mL/100mL 0699-1081_4aa9c035-4d22-4c12-a3fd-e6575c6d13c5 0699-1081 HUMAN PRESCRIPTION DRUG Hemoban Aluminum Chloride SOLUTION DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare ALUMINUM CHLORIDE 250 mg/g 0699-1082_4aa9c035-4d22-4c12-a3fd-e6575c6d13c5 0699-1082 HUMAN PRESCRIPTION DRUG Hemoban Aluminum Chloride SOLUTION DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare ALUMINUM CHLORIDE 250 mg/g 0699-3001_3e48140f-4644-4bae-8301-dc5c15dbc8ce 0699-3001 HUMAN PRESCRIPTION DRUG Topex Pina Colada Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0699-5720_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5720 HUMAN OTC DRUG Moist SURE Triclosan LIQUID TOPICAL 20060306 OTC MONOGRAPH FINAL part333E DSHealthcare TRICLOSAN 7.5 mg/g 0699-5725_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5725 HUMAN OTC DRUG Moist SURE Triclosan LIQUID TOPICAL 19920102 OTC MONOGRAPH FINAL part333E DSHealthcare TRICLOSAN 5 mg/g 0699-5726_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5726 HUMAN OTC DRUG Moist SURE Triclosan LIQUID TOPICAL 19920102 OTC MONOGRAPH FINAL part333E DSHealthcare TRICLOSAN 5 mg/g 0699-5727_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5727 HUMAN OTC DRUG Moist SURE Triclosan LIQUID TOPICAL 19920102 OTC MONOGRAPH FINAL part333E DSHealthcare TRICLOSAN 5 mg/g 0699-5728_5d37273b-697b-4656-89e8-ae06422809e9 0699-5728 HUMAN OTC DRUG Moist SURE Triclosan LIQUID TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part333E DSHealthcare TRICLOSAN 5 g/L 0699-5740_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5740 HUMAN OTC DRUG Moist SURE Isopropyl Alcohol LIQUID TOPICAL 20040501 OTC MONOGRAPH FINAL part333E DSHealthcare ISOPROPYL ALCOHOL 630 mg/g 0699-5741_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5741 HUMAN OTC DRUG Moist SURE Isopropyl Alcohol LIQUID TOPICAL 20040501 OTC MONOGRAPH FINAL part333E DSHealthcare ISOPROPYL ALCOHOL 630 mg/g 0699-5742_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5742 HUMAN OTC DRUG Moist SURE Isopropyl Alcohol LIQUID TOPICAL 20040501 OTC MONOGRAPH FINAL part333E DSHealthcare ISOPROPYL ALCOHOL 630 mg/g 0699-5743_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5743 HUMAN OTC DRUG Moist SURE Isopropyl Alcohol LIQUID TOPICAL 20040501 OTC MONOGRAPH FINAL part333E DSHealthcare ISOPROPYL ALCOHOL 630 mg/g 0699-5750_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5750 HUMAN OTC DRUG Moist SURE Alcohol LIQUID TOPICAL 19880102 OTC MONOGRAPH FINAL part333E DSHealthcare ALCOHOL 620 mg/g 0699-5751_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5751 HUMAN OTC DRUG Moist SURE Alcohol LIQUID TOPICAL 19880102 OTC MONOGRAPH FINAL part333E DSHealthcare ALCOHOL 620 mg/g 0699-7011_3e48140f-4644-4bae-8301-dc5c15dbc8ce 0699-7011 HUMAN PRESCRIPTION DRUG Topex Mint Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0699-7021_3e48140f-4644-4bae-8301-dc5c15dbc8ce 0699-7021 HUMAN PRESCRIPTION DRUG Topex Cherry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0699-7031_3e48140f-4644-4bae-8301-dc5c15dbc8ce 0699-7031 HUMAN PRESCRIPTION DRUG Topex Bubble Gum Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0699-7041_3e48140f-4644-4bae-8301-dc5c15dbc8ce 0699-7041 HUMAN PRESCRIPTION DRUG Topex Banana Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0699-7051_3e48140f-4644-4bae-8301-dc5c15dbc8ce 0699-7051 HUMAN PRESCRIPTION DRUG Topex Strawberry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0699-7061_3e48140f-4644-4bae-8301-dc5c15dbc8ce 0699-7061 HUMAN PRESCRIPTION DRUG Topex Raspberry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0699-7071_3e48140f-4644-4bae-8301-dc5c15dbc8ce 0699-7071 HUMAN PRESCRIPTION DRUG Topex Cherry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0699-7081_3e48140f-4644-4bae-8301-dc5c15dbc8ce 0699-7081 HUMAN PRESCRIPTION DRUG Topex Mint Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0699-7091_3e48140f-4644-4bae-8301-dc5c15dbc8ce 0699-7091 HUMAN PRESCRIPTION DRUG Topex Pina Colada Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0699-7100_3e48140f-4644-4bae-8301-dc5c15dbc8ce 0699-7100 HUMAN PRESCRIPTION DRUG Topex Bubble Gum Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0703-0018_1c9bdcfc-f79c-4d3a-8481-9405050b1638 0703-0018 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110118 ANDA ANDA078591 Teva Parenteral Medicines, Inc. HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0703-0031_7d7d7c04-97e2-43b8-9b42-54e3d507f6b4 0703-0031 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 20050308 ANDA ANDA040557 Teva Parenteral Medicines, Inc. METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0703-0043_0531c6ad-dc3b-4a5a-b484-c8d88fc88812 0703-0043 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 20061031 ANDA ANDA040620 Teva Parenteral Medicines, Inc. METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0703-0045_0531c6ad-dc3b-4a5a-b484-c8d88fc88812 0703-0045 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 20061031 ANDA ANDA040620 Teva Parenteral Medicines, Inc. METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0703-0051_7d7d7c04-97e2-43b8-9b42-54e3d507f6b4 0703-0051 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 20050308 ANDA ANDA040557 Teva Parenteral Medicines, Inc. METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0703-0063_0531c6ad-dc3b-4a5a-b484-c8d88fc88812 0703-0063 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 20061031 ANDA ANDA040620 Teva Parenteral Medicines, Inc. METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0703-0110_1c9bdcfc-f79c-4d3a-8481-9405050b1638 0703-0110 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110118 ANDA ANDA078591 Teva Parenteral Medicines, Inc. HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0703-0113_1c9bdcfc-f79c-4d3a-8481-9405050b1638 0703-0113 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110118 ANDA ANDA078591 Teva Parenteral Medicines, Inc. HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0703-0404_515cace8-1dd0-492b-8553-77eee7853fb3 0703-0404 HUMAN PRESCRIPTION DRUG Levocarnitine Levocarnitine INJECTION INTRAVENOUS 20010601 ANDA ANDA075881 Teva Parenteral Medicines, Inc. LEVOCARNITINE 1 g/5mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] 0703-0405_515cace8-1dd0-492b-8553-77eee7853fb3 0703-0405 HUMAN PRESCRIPTION DRUG Levocarnitine Levocarnitine INJECTION INTRAVENOUS 20010601 ANDA ANDA075881 Teva Parenteral Medicines, Inc. LEVOCARNITINE 2.5 g/12.5mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] 0703-1153_633ecfca-e612-40af-9e43-9ace510e350d 0703-1153 HUMAN PRESCRIPTION DRUG Norepinephrine bitartrate Norepinephrine bitartrate INJECTION INTRAVENOUS 20030401 ANDA ANDA040455 Teva Parenteral Medicines, Inc. NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 0703-1501_af83c8d5-74b4-4b1f-9fc1-2d4c302d6fb6 0703-1501 HUMAN PRESCRIPTION DRUG Alprostadil Alprostadil INJECTION INTRAVASCULAR 19990430 ANDA ANDA075196 Teva Parenteral Medicines, Inc ALPROSTADIL 500 ug/mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 0703-1985_7af8977b-0486-4f12-9a92-b31119dbd84f 0703-1985 HUMAN PRESCRIPTION DRUG Epoprostenol Sodium Epoprostenol Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080423 ANDA ANDA078396 Teva Parenteral Medicines, Inc. EPOPROSTENOL SODIUM .5 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] 0703-1995_7af8977b-0486-4f12-9a92-b31119dbd84f 0703-1995 HUMAN PRESCRIPTION DRUG Epoprostenol Sodium Epoprostenol Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080423 ANDA ANDA078396 Teva Parenteral Medicines, Inc. EPOPROSTENOL SODIUM 1.5 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] 0703-2191_bea5e05d-c35d-4784-8b11-d10bfc331d05 0703-2191 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20021001 ANDA ANDA040454 Teva Parenteral Medicines, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0703-2201_bea5e05d-c35d-4784-8b11-d10bfc331d05 0703-2201 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20021001 ANDA ANDA040454 Teva Parenteral Medicines, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0703-2394_6918138d-1309-4bc2-8e49-7c537f993edb 0703-2394 HUMAN PRESCRIPTION DRUG Rocuronium Bromide Rocuronium Bromide INJECTION, SOLUTION INTRAVENOUS 20081201 ANDA ANDA078717 Teva Parenteral Medicines, Inc ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0703-2395_6918138d-1309-4bc2-8e49-7c537f993edb 0703-2395 HUMAN PRESCRIPTION DRUG Rocuronium Bromide Rocuronium Bromide INJECTION, SOLUTION INTRAVENOUS 20081201 ANDA ANDA078717 Teva Parenteral Medicines, Inc ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0703-2804_5ef3b87e-6f66-483f-b274-b80f77328fbf 0703-2804 HUMAN PRESCRIPTION DRUG Pancuronium Bromide Pancuronium Bromide INJECTION, SOLUTION INTRAVENOUS 19900801 ANDA ANDA072759 Teva Parenteral Medicines, Inc. PANCURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0703-2812_5ef3b87e-6f66-483f-b274-b80f77328fbf 0703-2812 HUMAN PRESCRIPTION DRUG Pancuronium Bromide Pancuronium Bromide INJECTION, SOLUTION INTRAVENOUS 19900801 ANDA ANDA072760 Teva Parenteral Medicines, Inc. PANCURONIUM BROMIDE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0703-2823_5ef3b87e-6f66-483f-b274-b80f77328fbf 0703-2823 HUMAN PRESCRIPTION DRUG Pancuronium Bromide Pancuronium Bromide INJECTION, SOLUTION INTRAVENOUS 19900801 ANDA ANDA072760 Teva Parenteral Medicines, Inc. PANCURONIUM BROMIDE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0703-2856_51708e21-ec7f-4ff5-9802-014ebea5ec80 0703-2856 HUMAN PRESCRIPTION DRUG Propofol Propofol INJECTION, EMULSION INTRAVENOUS 20070621 ANDA ANDA075102 Teva Parenteral Medicines, Inc. PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 0703-2858_51708e21-ec7f-4ff5-9802-014ebea5ec80 0703-2858 HUMAN PRESCRIPTION DRUG Propofol Propofol INJECTION, EMULSION INTRAVENOUS 20070621 ANDA ANDA075102 Teva Parenteral Medicines, Inc. PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 0703-2859_51708e21-ec7f-4ff5-9802-014ebea5ec80 0703-2859 HUMAN PRESCRIPTION DRUG Propofol Propofol INJECTION, EMULSION INTRAVENOUS 20070621 ANDA ANDA075102 Teva Parenteral Medicines, Inc. PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 0703-2914_b7abb112-ce7a-41b3-a4c9-63363da8a096 0703-2914 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20021114 ANDA ANDA074688 Teva Parenteral Medicines, Inc. VECURONIUM BROMIDE 10 mg/10mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0703-2925_b7abb112-ce7a-41b3-a4c9-63363da8a096 0703-2925 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20021114 ANDA ANDA074688 Teva Parenteral Medicines, Inc. VECURONIUM BROMIDE 20 mg/20mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0703-3015_ee329443-8fe3-4d79-9594-592dbaaf71c7 0703-3015 HUMAN PRESCRIPTION DRUG ADRUCIL fluorouracil INJECTION INTRAVENOUS 20031001 ANDA ANDA040333 Teva Parenteral Medicines, Inc. FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0703-3018_dd0007df-b7e7-4410-84a7-8bd5e5fffef5 0703-3018 HUMAN PRESCRIPTION DRUG ADRUCIL fluorouracil INJECTION INTRAVENOUS 20031001 ANDA ANDA040334 Teva Parenteral Medicines, Inc. FLUOROURACIL 2.5 g/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0703-3019_dd0007df-b7e7-4410-84a7-8bd5e5fffef5 0703-3019 HUMAN PRESCRIPTION DRUG ADRUCIL fluorouracil INJECTION INTRAVENOUS 20031001 ANDA ANDA040334 Teva Parenteral Medicines, Inc. FLUOROURACIL 5 g/100mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0703-3067_e4cdac2c-f822-40e7-8bc6-9396e32d64f8 0703-3067 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride Epirubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20070809 ANDA ANDA065331 Teva Parenteral Medicines, Inc. EPIRUBICIN HYDROCHLORIDE 50 mg/25mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0703-3069_e4cdac2c-f822-40e7-8bc6-9396e32d64f8 0703-3069 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride Epirubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20070809 ANDA ANDA065331 Teva Parenteral Medicines, Inc. EPIRUBICIN HYDROCHLORIDE 200 mg/100mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0703-3154_437ba650-74d0-41c4-a7c3-30a618c95c0b 0703-3154 HUMAN PRESCRIPTION DRUG Bleomycin Bleomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS 20000630 ANDA ANDA065033 Teva Parenteral Medicines, Inc. BLEOMYCIN SULFATE 15 [USP'U]/1 Cytoprotective Agent [EPC] 0703-3155_437ba650-74d0-41c4-a7c3-30a618c95c0b 0703-3155 HUMAN PRESCRIPTION DRUG Bleomycin Bleomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS 20000630 ANDA ANDA065033 Teva Parenteral Medicines, Inc. BLEOMYCIN SULFATE 30 [USP'U]/1 Cytoprotective Agent [EPC] 0703-3249_670b25ff-ff6d-4311-8750-ad462eae168d 0703-3249 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION INTRAVENOUS 20051117 ANDA ANDA077139 Teva Parenteral Medicines, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0703-3301_1088278d-44c4-4cb3-8b3c-f1b4dda04230 0703-3301 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20051114 ANDA ANDA075957 Teva Parenteral Medicines, Inc OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 0703-3311_1088278d-44c4-4cb3-8b3c-f1b4dda04230 0703-3311 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20051114 ANDA ANDA075957 Teva Parenteral Medicines, Inc OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 0703-3321_1088278d-44c4-4cb3-8b3c-f1b4dda04230 0703-3321 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20051114 ANDA ANDA075957 Teva Parenteral Medicines, Inc OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 0703-3333_1088278d-44c4-4cb3-8b3c-f1b4dda04230 0703-3333 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20051123 ANDA ANDA075959 Teva Parenteral Medicines, Inc OCTREOTIDE ACETATE 200 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 0703-3343_1088278d-44c4-4cb3-8b3c-f1b4dda04230 0703-3343 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20051123 ANDA ANDA075959 Teva Parenteral Medicines, Inc OCTREOTIDE ACETATE 1000 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 0703-3427_b38a4778-c60f-4357-ba4a-b325c1790efb 0703-3427 HUMAN PRESCRIPTION DRUG Ifosfamide Ifosfamide INJECTION INTRAVENOUS 20070726 ANDA ANDA076657 Teva Parenteral Medicines, Inc. IFOSFAMIDE 1 g/20mL Alkylating Activity [MoA],Alkylating Drug [EPC] 0703-3429_b38a4778-c60f-4357-ba4a-b325c1790efb 0703-3429 HUMAN PRESCRIPTION DRUG Ifosfamide Ifosfamide INJECTION INTRAVENOUS 20070726 ANDA ANDA076657 Teva Parenteral Medicines, Inc. IFOSFAMIDE 3 g/60mL Alkylating Activity [MoA],Alkylating Drug [EPC] 0703-3671_1191608e-ba19-432e-bcb9-120727af00c3 0703-3671 HUMAN PRESCRIPTION DRUG METHOTREXATE methotrexate sodium INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120731 ANDA ANDA040850 Teva Parenteral Medicines, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0703-3671_35283918-f4bb-401c-a930-95fe6616c290 0703-3671 HUMAN PRESCRIPTION DRUG METHOTREXATE methotrexate sodium INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120731 ANDA ANDA040850 Teva Parenteral Medicines, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0703-3673_1191608e-ba19-432e-bcb9-120727af00c3 0703-3673 HUMAN PRESCRIPTION DRUG METHOTREXATE methotrexate sodium INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120801 ANDA ANDA200171 Teva Parenteral Medicines, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0703-3675_1191608e-ba19-432e-bcb9-120727af00c3 0703-3675 HUMAN PRESCRIPTION DRUG METHOTREXATE methotrexate sodium INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120801 ANDA ANDA040853 Teva Parenteral Medicines, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0703-3675_35283918-f4bb-401c-a930-95fe6616c290 0703-3675 HUMAN PRESCRIPTION DRUG METHOTREXATE methotrexate sodium INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120801 ANDA ANDA040853 Teva Parenteral Medicines, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0703-3678_1191608e-ba19-432e-bcb9-120727af00c3 0703-3678 HUMAN PRESCRIPTION DRUG METHOTREXATE methotrexate sodium INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120801 ANDA ANDA040843 Teva Parenteral Medicines, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0703-3985_b09f266e-e82b-476d-bccf-78d3e4c749c9 0703-3985 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090811 NDA NDA022160 Teva Parenteral Medicines, Inc. OXALIPLATIN 50 mg/10mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0703-3986_b09f266e-e82b-476d-bccf-78d3e4c749c9 0703-3986 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090811 NDA NDA022160 Teva Parenteral Medicines, Inc. OXALIPLATIN 100 mg/20mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0703-4075_b048bb1d-ea10-479b-8c20-acae976b3dc6 0703-4075 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, SOLUTION INTRAVENOUS 20020401 ANDA ANDA076153 Teva Parenteral Medicines, Inc. PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0703-4085_b048bb1d-ea10-479b-8c20-acae976b3dc6 0703-4085 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, SOLUTION INTRAVENOUS 20020401 ANDA ANDA076153 Teva Parenteral Medicines, Inc. PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 0703-4100_6eefde29-ed55-4bc9-aa00-37c87db3c560 0703-4100 HUMAN PRESCRIPTION DRUG Ifosfamide and Mesna Ifosfamide and Mesna KIT 20020501 ANDA ANDA075874 Teva Parenteral Medicines, Inc 0703-4106_6eefde29-ed55-4bc9-aa00-37c87db3c560 0703-4106 HUMAN PRESCRIPTION DRUG Ifosfamide and Mesna Ifosfamide and Mesna KIT 20120926 ANDA ANDA075874 Teva Parenteral Medicines, Inc 0703-4116_6eefde29-ed55-4bc9-aa00-37c87db3c560 0703-4116 HUMAN PRESCRIPTION DRUG Ifosfamide and Mesna Ifosfamide and Mesna KIT 20120926 ANDA ANDA075874 Teva Parenteral Medicines, Inc 0703-4154_04846129-565c-4b1c-aec6-4191ada56a52 0703-4154 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride idarubicin hydrochloride INJECTION INTRAVENOUS 20021001 ANDA ANDA065036 Teva Parenteral Medicines, Inc IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0703-4155_04846129-565c-4b1c-aec6-4191ada56a52 0703-4155 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride idarubicin hydrochloride INJECTION INTRAVENOUS 20021001 ANDA ANDA065036 Teva Parenteral Medicines, Inc IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0703-4156_04846129-565c-4b1c-aec6-4191ada56a52 0703-4156 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride idarubicin hydrochloride INJECTION INTRAVENOUS 20021001 ANDA ANDA065036 Teva Parenteral Medicines, Inc IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0703-4182_64b26cd8-7d44-4677-bd80-b5d6716e43a3 0703-4182 HUMAN PRESCRIPTION DRUG Vinorelbine Vinorelbine INJECTION INTRAVENOUS 20030301 ANDA ANDA076028 Teva Parenteral Medicines, Inc. VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 0703-4183_64b26cd8-7d44-4677-bd80-b5d6716e43a3 0703-4183 HUMAN PRESCRIPTION DRUG Vinorelbine Vinorelbine INJECTION INTRAVENOUS 20030301 ANDA ANDA076028 Teva Parenteral Medicines, Inc. VINORELBINE TARTRATE 50 mg/5mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 0703-4239_8a02dbf8-1ceb-4870-923b-4b925246fc95 0703-4239 HUMAN PRESCRIPTION DRUG CARBOplatin CARBOplatin INJECTION, SOLUTION INTRAVENOUS 20140731 ANDA ANDA077269 Teva Parenteral Medicines, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0703-4244_8a02dbf8-1ceb-4870-923b-4b925246fc95 0703-4244 HUMAN PRESCRIPTION DRUG CARBOplatin CARBOplatin INJECTION, SOLUTION INTRAVENOUS 20060504 ANDA ANDA077269 Teva Parenteral Medicines, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0703-4246_8a02dbf8-1ceb-4870-923b-4b925246fc95 0703-4246 HUMAN PRESCRIPTION DRUG CARBOplatin CARBOplatin INJECTION, SOLUTION INTRAVENOUS 20060501 ANDA ANDA077269 Teva Parenteral Medicines, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0703-4248_8a02dbf8-1ceb-4870-923b-4b925246fc95 0703-4248 HUMAN PRESCRIPTION DRUG CARBOplatin CARBOplatin INJECTION, SOLUTION INTRAVENOUS 20060201 ANDA ANDA077269 Teva Parenteral Medicines, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0703-4402_65558579-3c84-4fd0-a21b-a19ff6eeef8a 0703-4402 HUMAN PRESCRIPTION DRUG Vincasar PFS vinCRIStine sulfate INJECTION, SOLUTION INTRAVENOUS 20000501 ANDA ANDA075493 Teva Parenteral Medicines, Inc. VINCRISTINE SULFATE 1 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 0703-4412_65558579-3c84-4fd0-a21b-a19ff6eeef8a 0703-4412 HUMAN PRESCRIPTION DRUG Vincasar PFS vinCRIStine sulfate INJECTION, SOLUTION INTRAVENOUS 20000501 ANDA ANDA075493 Teva Parenteral Medicines, Inc. VINCRISTINE SULFATE 1 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 0703-4432_774ba325-ce88-463d-8859-102c53dba1f9 0703-4432 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20080228 ANDA ANDA090101 Teva Parenteral Medicines, Inc. IRINOTECAN HYDROCHLORIDE 40 mg/2mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0703-4434_774ba325-ce88-463d-8859-102c53dba1f9 0703-4434 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20080227 ANDA ANDA090101 Teva Parenteral Medicines, Inc. IRINOTECAN HYDROCHLORIDE 100 mg/5mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0703-4502_191cdc9f-5d64-4e25-a0a1-a66327a87bc1 0703-4502 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911201 ANDA ANDA073135 Teva Parenteral Medicines, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0703-4502_5645a752-8868-4b51-8b59-48bb4276d763 0703-4502 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911201 ANDA ANDA073135 Teva Parenteral Medicines, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 0703-4636_3ea01059-8c39-431c-a1c4-c03315b083e1 0703-4636 HUMAN PRESCRIPTION DRUG Zanosar streptozocin POWDER, FOR SOLUTION INTRAVENOUS 20031203 NDA NDA050577 Teva Parenteral Medicines, Inc. STREPTOZOCIN 100 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] 0703-4680_05ad968b-cc06-4518-af87-1eacc7cc92f1 0703-4680 HUMAN PRESCRIPTION DRUG mitoXANTRONE mitoXANTRONE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060411 ANDA ANDA077356 Teva Parenteral Medicines, Inc MITOXANTRONE HYDROCHLORIDE 2 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0703-4685_05ad968b-cc06-4518-af87-1eacc7cc92f1 0703-4685 HUMAN PRESCRIPTION DRUG mitoXANTRONE mitoXANTRONE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060411 ANDA ANDA077356 Teva Parenteral Medicines, Inc MITOXANTRONE HYDROCHLORIDE 2 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0703-4686_05ad968b-cc06-4518-af87-1eacc7cc92f1 0703-4686 HUMAN PRESCRIPTION DRUG mitoXANTRONE mitoXANTRONE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060411 ANDA ANDA077356 Teva Parenteral Medicines, Inc MITOXANTRONE HYDROCHLORIDE 2 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0703-4714_42877536-ef36-4b47-9ac8-239055414ea3 0703-4714 HUMAN PRESCRIPTION DRUG Topotecan Topotecan INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130521 NDA NDA022453 Teva Parenteral Medicines, Inc. TOPOTECAN HYDROCHLORIDE 1 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0703-4764_1cb73d76-10f3-419c-868d-df50d1d86225 0703-4764 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION INTRAVENOUS 20091103 ANDA ANDA075184 Teva Parenteral Medicines, Inc. PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 0703-4766_1cb73d76-10f3-419c-868d-df50d1d86225 0703-4766 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION INTRAVENOUS 20080924 ANDA ANDA075184 Teva Parenteral Medicines, Inc. PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 0703-4767_1cb73d76-10f3-419c-868d-df50d1d86225 0703-4767 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION INTRAVENOUS 20081023 ANDA ANDA075184 Teva Parenteral Medicines, Inc. PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 0703-4768_1cb73d76-10f3-419c-868d-df50d1d86225 0703-4768 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION INTRAVENOUS 20090916 ANDA ANDA075184 Teva Parenteral Medicines, Inc. PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 0703-4805_edad4cd9-6bab-4a47-a9c5-8e5d3584de83 0703-4805 HUMAN PRESCRIPTION DRUG Mesna Mesna INJECTION, SOLUTION INTRAVENOUS 20020501 ANDA ANDA075764 Teva Parenteral Medicines, Inc MESNA 100 mg/mL Cytoprotective Agent [EPC] 0703-4852_b9117c58-7c84-4bf9-910e-6b7808c26d77 0703-4852 HUMAN PRESCRIPTION DRUG Fludarabine Phosphate Fludarabine Phosphate INJECTION INTRAVENOUS 20040501 ANDA ANDA076661 Teva Parenteral Medicines, Inc. FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0703-5040_0f82f5ce-e1c2-4ae5-a1c3-e35d1a4b52cf 0703-5040 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride doxorubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 19960901 ANDA ANDA064140 Teva Parenteral Medicines, Inc. DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0703-5043_0f82f5ce-e1c2-4ae5-a1c3-e35d1a4b52cf 0703-5043 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride doxorubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 19950901 ANDA ANDA064140 Teva Parenteral Medicines, Inc. DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0703-5046_0f82f5ce-e1c2-4ae5-a1c3-e35d1a4b52cf 0703-5046 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride doxorubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 19950901 ANDA ANDA064140 Teva Parenteral Medicines, Inc. DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0703-5051_ff87d1d1-98e4-42d0-afba-34cd1a7f2b2e 0703-5051 HUMAN PRESCRIPTION DRUG Desmopressin acetate Desmopressin acetate INJECTION INTRAVENOUS 19971101 ANDA ANDA074888 Teva Parenteral Medicines, Inc. DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 0703-5054_ff87d1d1-98e4-42d0-afba-34cd1a7f2b2e 0703-5054 HUMAN PRESCRIPTION DRUG Desmopressin acetate Desmopressin acetate INJECTION INTRAVENOUS 19971101 ANDA ANDA074888 Teva Parenteral Medicines, Inc. DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 0703-5075_6924c6f7-4b72-43d8-bbcd-8133ca0c9f8f 0703-5075 HUMAN PRESCRIPTION DRUG Dacarbazine Dacarbazine INJECTION INTRAVENOUS 19980827 ANDA ANDA075259 Teva Parenteral Medicines, Inc DACARBAZINE 200 mg/20mL Alkylating Activity [MoA],Alkylating Drug [EPC] 0703-5140_f7ee4005-2916-4fb2-bbc2-fe6fe9953c75 0703-5140 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19940201 ANDA ANDA081277 Teva Parenteral Medicines, Inc. LEUCOVORIN CALCIUM 100 mg/10mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 0703-5145_0d9c47c2-42f2-4e98-bde0-4bbc34501c76 0703-5145 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970612 ANDA ANDA040174 Teva Parenteral Medicines, Inc. LEUCOVORIN CALCIUM 350 mg/17.5mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 0703-5145_f7ee4005-2916-4fb2-bbc2-fe6fe9953c75 0703-5145 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970612 ANDA ANDA040174 Teva Parenteral Medicines, Inc. LEUCOVORIN CALCIUM 350 mg/17.5mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 0703-5233_7b50db67-621a-4022-a9d1-186683a1a52d 0703-5233 HUMAN PRESCRIPTION DRUG daunorubicin hydrochloride daunorubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 20040401 ANDA ANDA065035 Teva Parenteral Medicines, Inc. DAUNORUBICIN HYDROCHLORIDE 5 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0703-5233_b4f2e95a-37fb-41f9-b8be-c96c884a5498 0703-5233 HUMAN PRESCRIPTION DRUG daunorubicin hydrochloride daunorubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 20040401 ANDA ANDA065035 Teva Parenteral Medicines, Inc. DAUNORUBICIN HYDROCHLORIDE 5 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 0703-5653_620a323d-7fbe-43ca-8c5c-b3ce64f54675 0703-5653 HUMAN PRESCRIPTION DRUG Toposar Etoposide INJECTION INTRAVENOUS 19960801 ANDA ANDA074529 Teva Parenteral Medicines, Inc ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0703-5656_620a323d-7fbe-43ca-8c5c-b3ce64f54675 0703-5656 HUMAN PRESCRIPTION DRUG Toposar Etoposide INJECTION INTRAVENOUS 19960801 ANDA ANDA074529 Teva Parenteral Medicines, Inc ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0703-5656_f2bb6be5-76fb-408b-bfb5-a0607070baa8 0703-5656 HUMAN PRESCRIPTION DRUG Toposar Etoposide INJECTION INTRAVENOUS 19960801 ANDA ANDA074529 Teva Parenteral Medicines, Inc. ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0703-5657_620a323d-7fbe-43ca-8c5c-b3ce64f54675 0703-5657 HUMAN PRESCRIPTION DRUG Toposar Etoposide INJECTION INTRAVENOUS 19970501 ANDA ANDA074529 Teva Parenteral Medicines, Inc ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0703-5657_f2bb6be5-76fb-408b-bfb5-a0607070baa8 0703-5657 HUMAN PRESCRIPTION DRUG Toposar Etoposide INJECTION INTRAVENOUS 19970501 ANDA ANDA074529 Teva Parenteral Medicines, Inc. ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 0703-5747_c26e5c72-fcb2-4eda-80e2-6b056a194c3a 0703-5747 HUMAN PRESCRIPTION DRUG Cisplatin Cisplatin INJECTION, SOLUTION INTRAVENOUS 20000601 ANDA ANDA074656 Teva Parenteral Medicines, Inc. CISPLATIN 50 mg/50mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0703-5748_c26e5c72-fcb2-4eda-80e2-6b056a194c3a 0703-5748 HUMAN PRESCRIPTION DRUG Cisplatin Cisplatin INJECTION, SOLUTION INTRAVENOUS 20000601 ANDA ANDA074656 Teva Parenteral Medicines, Inc. CISPLATIN 100 mg/100mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0703-5775_f9bcfa1e-d3b6-4d9f-9c35-c3daefd1f23f 0703-5775 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110714 ANDA ANDA077983 Teva Parenteral Medicines, Inc. GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0703-5778_f9bcfa1e-d3b6-4d9f-9c35-c3daefd1f23f 0703-5778 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110714 ANDA ANDA077983 Teva Parenteral Medicines, Inc. GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0703-5854_967129da-cdf5-43b6-a34b-f9e7c6a9a119 0703-5854 HUMAN PRESCRIPTION DRUG Fludarabine Phosphate Fludarabine Phosphate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20030912 ANDA ANDA076349 Teva Parenteral Medicines, Inc. FLUDARABINE PHOSPHATE 50 mg/2mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0703-6801_a5795630-4336-4462-bd78-901da36cc8a3 0703-6801 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate medroxyprogesterone acetate INJECTION INTRAMUSCULAR 20040914 ANDA ANDA076553 Teva Parenteral Medicines, Inc MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0703-7011_ccdd08ca-b612-4204-b34b-5635fa1ce692 0703-7011 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 19990604 ANDA ANDA075393 Teva Parenteral Medicines, Inc. HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] 0703-7013_ccdd08ca-b612-4204-b34b-5635fa1ce692 0703-7013 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 19990701 ANDA ANDA075393 Teva Parenteral Medicines, Inc. HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] 0703-7021_ccdd08ca-b612-4204-b34b-5635fa1ce692 0703-7021 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 19990604 ANDA ANDA075393 Teva Parenteral Medicines, Inc. HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] 0703-7023_ccdd08ca-b612-4204-b34b-5635fa1ce692 0703-7023 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 19990701 ANDA ANDA075393 Teva Parenteral Medicines, Inc. HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] 0703-7041_15f27e43-5d33-4373-8903-14cc1ed98d72 0703-7041 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol INJECTION INTRAMUSCULAR 20020301 ANDA ANDA076035 Teva Parenteral Medicines, Inc. HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] 0703-7045_15f27e43-5d33-4373-8903-14cc1ed98d72 0703-7045 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol INJECTION INTRAMUSCULAR 20020301 ANDA ANDA076035 Teva Parenteral Medicines, Inc. HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] 0703-7221_3fb14a72-4af2-429b-8c1b-e0c1d9997ae1 0703-7221 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20061122 ANDA ANDA076759 Teva Parenteral Medicines, Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0703-7226_76a60079-50bc-4cd7-9a30-b50fefe2f399 0703-7226 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20061122 ANDA ANDA076876 Teva Parenteral Medicines, Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0703-7351_8bb5c1a2-4e1f-4abe-9019-526481dd1df2 0703-7351 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate INJECTION SUBCUTANEOUS 20090206 ANDA ANDA077907 Teva Parenteral Medicines, Inc SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0703-8401_b8c7b40f-29e4-4b60-8299-be32a00de4b5 0703-8401 HUMAN PRESCRIPTION DRUG Enalaprilat enalaprilat INJECTION INTRAVENOUS 20051006 ANDA ANDA075578 Teva Parenteral Medicines, Inc ENALAPRILAT 1.25 mg/mL Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0703-8411_b8c7b40f-29e4-4b60-8299-be32a00de4b5 0703-8411 HUMAN PRESCRIPTION DRUG Enalaprilat enalaprilat INJECTION INTRAVENOUS 20051006 ANDA ANDA075578 Teva Parenteral Medicines, Inc ENALAPRILAT 1.25 mg/mL Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0703-8510_788697fa-5c04-4c6d-8253-6e23b758769d 0703-8510 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140926 ANDA ANDA076726 Teva Parenteral Medicines, Inc. ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0703-8530_788697fa-5c04-4c6d-8253-6e23b758769d 0703-8530 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140926 ANDA ANDA076726 Teva Parenteral Medicines, Inc. ENOXAPARIN SODIUM 30 mg/.3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0703-8540_788697fa-5c04-4c6d-8253-6e23b758769d 0703-8540 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140926 ANDA ANDA076726 Teva Parenteral Medicines, Inc. ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0703-8560_788697fa-5c04-4c6d-8253-6e23b758769d 0703-8560 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140926 ANDA ANDA076726 Teva Parenteral Medicines, Inc. ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0703-8580_788697fa-5c04-4c6d-8253-6e23b758769d 0703-8580 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140926 ANDA ANDA076726 Teva Parenteral Medicines, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0703-8610_788697fa-5c04-4c6d-8253-6e23b758769d 0703-8610 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140926 ANDA ANDA076726 Teva Parenteral Medicines, Inc. ENOXAPARIN SODIUM 120 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0703-8680_788697fa-5c04-4c6d-8253-6e23b758769d 0703-8680 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140926 ANDA ANDA076726 Teva Parenteral Medicines, Inc. ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0703-8776_72b32306-bb3e-473d-89e1-c581973135ac 0703-8776 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20130923 ANDA ANDA077425 Teva Parenteral Medicines, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 0703-8777_72b32306-bb3e-473d-89e1-c581973135ac 0703-8777 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20130923 ANDA ANDA077425 Teva Parenteral Medicines, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 0703-9032_08df55c0-7ab3-4398-8008-001d4f8fe262 0703-9032 HUMAN PRESCRIPTION DRUG Amikacin Sulfate Amikacin Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS 19931001 ANDA ANDA064045 Teva Parenteral Medicines, Inc. AMIKACIN SULFATE 500 mg/2mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0703-9032_7157ff63-edcd-484d-b65a-d08764a8428e 0703-9032 HUMAN PRESCRIPTION DRUG Amikacin Sulfate Amikacin Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19931001 ANDA ANDA064045 Teva Parenteral Medicines, Inc. AMIKACIN SULFATE 500 mg/2mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0703-9040_08df55c0-7ab3-4398-8008-001d4f8fe262 0703-9040 HUMAN PRESCRIPTION DRUG Amikacin Sulfate Amikacin Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS 19931001 ANDA ANDA064045 Teva Parenteral Medicines, Inc. AMIKACIN SULFATE 1 g/4mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0703-9040_7157ff63-edcd-484d-b65a-d08764a8428e 0703-9040 HUMAN PRESCRIPTION DRUG Amikacin Sulfate Amikacin Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19931001 ANDA ANDA064045 Teva Parenteral Medicines, Inc. AMIKACIN SULFATE 1 g/4mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0703-9095_456a9090-31aa-4901-8ff1-9144f123fee1 0703-9095 HUMAN PRESCRIPTION DRUG NAFCILLIN SODIUM NAFCILLIN SODIUM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140408 ANDA ANDA200002 Teva Parenteral Medicines, Inc. NAFCILLIN SODIUM 1 g/4mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0703-9105_456a9090-31aa-4901-8ff1-9144f123fee1 0703-9105 HUMAN PRESCRIPTION DRUG NAFCILLIN SODIUM NAFCILLIN SODIUM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140409 ANDA ANDA200002 Teva Parenteral Medicines, Inc. NAFCILLIN SODIUM 2 g/8mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0703-9258_7af8977b-0486-4f12-9a92-b31119dbd84f 0703-9258 HUMAN PRESCRIPTION DRUG Sterile Diluent Sterile Diluent INJECTION INTRAVENOUS 20080423 ANDA ANDA078396 Teva Parenteral Medicines, Inc. WATER 1 mL/mL 0703-9503_d39fe231-d9a6-4396-86ff-5ff23ee40e81 0703-9503 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim sulfamethoxazole and trimethoprim INJECTION, SOLUTION INTRAVENOUS 19911101 ANDA ANDA073303 Teva Parenteral Medicines, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 80; 16 mg/mL; mg/mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0703-9514_d39fe231-d9a6-4396-86ff-5ff23ee40e81 0703-9514 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim sulfamethoxazole and trimethoprim INJECTION, SOLUTION INTRAVENOUS 19911101 ANDA ANDA073303 Teva Parenteral Medicines, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 80; 16 mg/mL; mg/mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0703-9526_d39fe231-d9a6-4396-86ff-5ff23ee40e81 0703-9526 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim sulfamethoxazole and trimethoprim INJECTION, SOLUTION INTRAVENOUS 19911101 ANDA ANDA073303 Teva Parenteral Medicines, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 80; 16 mg/mL; mg/mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0713-0101_2d1c5464-7c85-4e78-42aa-f0d4a2b7fe93 0713-0101 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 19870608 OTC MONOGRAPH NOT FINAL part334 G&W Laboratories, Inc. GLYCERIN 2.1 g/1 0713-0102_e73c87dc-b94c-fe96-7d7d-e40b5b795546 0713-0102 HUMAN OTC DRUG Pediatric Glycerin Glycerin SUPPOSITORY RECTAL 19870608 OTC MONOGRAPH NOT FINAL part334 G&W Laboratories, Inc. GLYCERIN 1.2 g/1 0713-0109_84c0edcc-0771-f286-abc7-d6be0300629f 0713-0109 HUMAN OTC DRUG BISAC-EVAC Bisacodyl SUPPOSITORY RECTAL 19910522 OTC MONOGRAPH NOT FINAL part334 G&W Laboratories, Inc. BISACODYL 10 mg/1 0713-0118_f22b8d30-5022-de4e-9585-2d5eba6d9957 0713-0118 HUMAN OTC DRUG ACEPHEN Acetaminophen SUPPOSITORY RECTAL 19820101 NDA NDA018060 G&W Laboratories, Inc. ACETAMINOPHEN 120 mg/1 0713-0132_1dd4b532-7463-f8db-f082-c1430016279d 0713-0132 HUMAN PRESCRIPTION DRUG PROMETHEGAN promethazine hydrochloride SUPPOSITORY RECTAL 19870831 ANDA ANDA087165 G&W Laboratories, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0713-0135_256f2b00-76e6-0650-c4c1-f2b6a24c9268 0713-0135 HUMAN PRESCRIPTION DRUG Prochlorperazine Prochlorperazine SUPPOSITORY RECTAL 19931130 ANDA ANDA040058 G&W Laboratories, Inc. PROCHLORPERAZINE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0713-0164_b342b1e9-d12d-f94d-9757-a700bbb0d218 0713-0164 HUMAN OTC DRUG ACEPHEN Acetaminophen SUPPOSITORY RECTAL 19920327 ANDA ANDA072344 G&W Laboratories, Inc. ACETAMINOPHEN 325 mg/1 0713-0165_c06a3b1d-c77a-0f88-0758-a87c4975d1ae 0713-0165 HUMAN OTC DRUG ACEPHEN Acetaminophen SUPPOSITORY RECTAL 19920327 ANDA ANDA072237 G&W Laboratories, Inc. ACETAMINOPHEN 650 mg/1 0713-0166_cdfcc1cc-3c7c-cc2c-ef14-6a5d1a4a75fe 0713-0166 HUMAN PRESCRIPTION DRUG MIGERGOT Ergotamine Tartrate and Caffeine SUPPOSITORY RECTAL 19831030 ANDA ANDA086557 G & W LABORATORIES, INC. CAFFEINE; ERGOTAMINE TARTRATE 100; 2 mg/1; mg/1 Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0713-0176_0c313fa9-19f8-7f06-76a8-214170309857 0713-0176 HUMAN PRESCRIPTION DRUG INDOMETHACIN INDOMETHACIN SUPPOSITORY RECTAL 19920831 ANDA ANDA073314 G & W LABORATORIES, INC. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0713-0197_b7df48ff-f359-cea4-bef2-39f7974f034c 0713-0197 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate SUPPOSITORY VAGINAL 19970430 ANDA ANDA074414 G&W Laboratories, Inc. MICONAZOLE NITRATE 100 ug/1 0713-0222_9796bcb9-51f9-c007-d607-73de9a0ab7f7 0713-0222 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide CREAM TOPICAL 19880726 ANDA ANDA089525 G&W Laboratories, Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0713-0223_9796bcb9-51f9-c007-d607-73de9a0ab7f7 0713-0223 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide CREAM TOPICAL 19880726 ANDA ANDA089526 G&W Laboratories, Inc. FLUOCINOLONE ACETONIDE .1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0713-0224_9796bcb9-51f9-c007-d607-73de9a0ab7f7 0713-0224 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OINTMENT TOPICAL 19880726 ANDA ANDA089524 G&W Laboratories, Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0713-0252_5c0d3219-91fe-6138-744d-822e707ac2e2 0713-0252 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate CREAM VAGINAL 19960222 ANDA ANDA074366 G&W Laboratories, Inc. MICONAZOLE NITRATE 20 mg/g 0713-0268_ee288720-fd49-aef3-fda4-761060ad08bb 0713-0268 HUMAN OTC DRUG Triple Antibiotic Ointment Polymyxin B Sulfate, Bacitracin Zinc, Neomycin Sulfate OINTMENT TOPICAL 19950111 OTC MONOGRAPH FINAL part333B G&W Laboratories, Inc. BACITRACIN ZINC; NEOMYCIN; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 0713-0280_e4a0e5d7-66d3-73fc-8a2a-c49b4b521989 0713-0280 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 19950110 OTC MONOGRAPH FINAL part333B G&W Laboratories, Inc. BACITRACIN 500 [USP'U]/g 0713-0317_e93f6c37-d244-b4c0-22e6-21d7e282471d 0713-0317 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SOLUTION TOPICAL 20070522 ANDA ANDA078233 GW Laboratories, Inc. CICLOPIROX 80 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 0713-0318_822ec14a-c6c5-1f39-2a32-39149d032ec1 0713-0318 HUMAN PRESCRIPTION DRUG Calcipotriene Calcipotriene SOLUTION TOPICAL 20110404 ANDA ANDA078468 G & W Laboratories, Inc. CALCIPOTRIENE .05 mg/mL Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 0713-0324_eb46ffb1-77b9-ec3e-7a7e-35dd67a82eaa 0713-0324 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide CREAM TOPICAL 20131220 ANDA ANDA089525 G&W Laboratories, Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0713-0503_f8125ab3-1dc4-ba10-718c-8263821efe67 0713-0503 HUMAN PRESCRIPTION DRUG ANUCORT-HC Hydrocortisone Acetate SUPPOSITORY RECTAL 19900115 UNAPPROVED DRUG OTHER G&W Laboratories, Inc. HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0713-0526_571ff6f4-47e4-5491-b6da-13a653960a6d 0713-0526 HUMAN PRESCRIPTION DRUG PROMETHEGAN Promethazine Hydrochloride SUPPOSITORY RECTAL 20020228 ANDA ANDA040428 G&W Laboratories, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0713-0535_17cecb0a-0c16-cdda-744e-a3dea9333e1e 0713-0535 HUMAN OTC DRUG Formulation R Phenylephrine Hydrochloride, Hydrogenate Palm Kernel Oil SUPPOSITORY RECTAL 20020624 OTC MONOGRAPH FINAL part346 G&W Laboratories, Inc. HYDROGENATED PALM KERNEL OIL; PHENYLEPHRINE HYDROCHLORIDE 855; 2.5 mg/1; mg/1 0713-0536_571ff6f4-47e4-5491-b6da-13a653960a6d 0713-0536 HUMAN PRESCRIPTION DRUG PROMETHEGAN promethazine hydrochloride SUPPOSITORY RECTAL 20040228 ANDA ANDA040428 G&W Laboratories, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0713-0622_cc87a9af-8a9f-5a57-b08c-f97b773ab743 0713-0622 HUMAN OTC DRUG Triple Antibiotic Plus Polymyxin B Sulfate, Bacitracin Zinc, Neomycin Sulfate, Pramoxine HCl OINTMENT TOPICAL 19980228 OTC MONOGRAPH FINAL part333B G&W Laboratories, Inc. BACITRACIN ZINC; NEOMYCIN; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 0713-0623_7e5dc3de-e933-327d-a055-625b921c46a1 0713-0623 HUMAN OTC DRUG Carlesta Dimethicone, Zinc Oxide OINTMENT TOPICAL 19990908 OTC MONOGRAPH FINAL part347 G&W Laboratories, Inc. DIMETHICONE; ZINC OXIDE 20; 260 mg/g; mg/g 0713-0631_310829d6-9cc4-d16c-5685-fd88fbd2250e 0713-0631 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate CREAM TOPICAL 20060630 ANDA ANDA077055 G&W Laboratories, Inc. FLUTICASONE PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0713-0632_f1e99169-7809-3ffe-9e1c-ee8f98fed4cd 0713-0632 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate OINTMENT TOPICAL 20060531 ANDA ANDA077168 GW Laboratories, Inc FLUTICASONE PROPIONATE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0713-0633_2a055cd1-eb71-c12f-6959-403845fa591d 0713-0633 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole CREAM TOPICAL 20080313 ANDA ANDA077549 G&W Laboratories, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0713-0634_49fec8d8-3e75-d3a9-0845-f404406c8091 0713-0634 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20060823 ANDA ANDA077447 G&W Laboratories, Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0713-0635_db1bb710-f95c-739f-5a4b-a9d7ad6bc573 0713-0635 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20140304 ANDA ANDA077401 G&W Laboratories, Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0713-0637_cf4e81fa-b24d-f099-6fd0-45120fe48bd7 0713-0637 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL TOPICAL 20110401 ANDA ANDA078178 G & W Laboratories, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0713-0638_06b01ba3-8f77-b0b3-a783-d61ed27dbffb 0713-0638 HUMAN PRESCRIPTION DRUG Ciclopirox Olamine Ciclopirox Olamine CREAM TOPICAL 20070522 ANDA ANDA078463 G & W Laboratories, Inc. CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 0713-0639_b4d8183b-3630-43be-0e06-1e2441786a20 0713-0639 HUMAN PRESCRIPTION DRUG Halobetasol Propionate Halobetasol Propionate OINTMENT TOPICAL 20070427 ANDA ANDA077721 G&W Laboratories, Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0713-0640_f403a903-8263-cfed-3956-a246eae740b0 0713-0640 HUMAN PRESCRIPTION DRUG Halobetasol Propionate Halobetasol Propionate CREAM TOPICAL 20070716 ANDA ANDA078162 G&W Laboratories, Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0713-0668_5f36b217-e55c-4f33-811e-534eb67eb00d 0713-0668 HUMAN PRESCRIPTION DRUG Hydrocortisone Valerate Hydrocortisone Valerate CREAM TOPICAL 19980825 ANDA ANDA075042 G&W Laboratories, Inc. HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0713-0701_3dc60051-b720-ed6f-823c-69f0b35cd3a0 0713-0701 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate SOLUTION TOPICAL 20140304 ANDA ANDA077678 G&W Laboratories, Inc. MOMETASONE FUROATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 0713-0703_3bb57616-ce87-5a68-17d7-8dc7f2963a1f 0713-0703 HUMAN PRESCRIPTION DRUG Hycet Hydrocodone bitartrate and acetaminophen SOLUTION ORAL 20110201 ANDA ANDA040482 G&W Laboratories, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0713-0704_7068bb40-bcc8-1d45-09e7-5dac7f01fe4a 0713-0704 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone bitartrate and acetaminophen SOLUTION ORAL 20110201 ANDA ANDA040482 G&W Laboratories, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII 0722-6094_d41932b8-c97c-4190-ba99-f17165960907 0722-6094 HUMAN PRESCRIPTION DRUG Ascomp with Codeine Butalbital, Aspirin, Cafeine, and Codeine Phosphate CAPSULE ORAL 20011130 ANDA ANDA075231 Nexgen Pharma, Inc. ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0722-6670_f0bea400-d85b-40b8-b6ca-15be7f32659a 0722-6670 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE ORAL 20040610 ANDA ANDA076560 Nexgen Pharma, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0722-6920_71508b14-3d59-408c-b43c-aff2f47b8b3d 0722-6920 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20060927 ANDA ANDA077706 Nexgen Pharma, Inc. POLYETHYLENE GLYCOL 3350 17 g/1 Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 0722-6921_d0d2f068-4453-4ea2-8282-339b6e497a9a 0722-6921 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20060927 ANDA ANDA077706 Nexgen Pharma, Inc. POLYETHYLENE GLYCOL 3350 17 g/1 Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 0722-7028_acba0f97-402d-41d4-82d3-37f3f7da8ac0 0722-7028 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE ORAL 20120720 ANDA ANDA076560 Nexgen Pharma, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 300; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 0722-7029_3d819ef5-f676-4d0d-b2d4-256136842750 0722-7029 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine Capsules CAPSULE ORAL 20091116 ANDA ANDA040885 Nexgen Pharma, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 300; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 0722-7075_0feca9fa-fde3-4d5d-bb6a-2886572933a0 0722-7075 HUMAN PRESCRIPTION DRUG Butalbital and Acetaminophen Butalbital and Acetaminophen TABLET ORAL 20110401 ANDA ANDA090956 Nexgen Pharma, Inc. ACETAMINOPHEN; BUTALBITAL 300; 50 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] CIII 0722-7097_06bb6f89-4694-4aaa-8bff-f7f3c81d3add 0722-7097 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20120312 ANDA ANDA091522 Nexgen Pharma, Inc. GLYCOPYRROLATE 1.5 mg/1 0722-7116_d6218f65-1b41-417e-b928-56ac6db411af 0722-7116 HUMAN OTC DRUG Polyethylene Glycol 3350, NF Powder for Solution, Laxative Polyethylene Glycol 3350, NF Powder for Solution, Laxative POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090812 Nexgen Pharma, Inc. POLYETHYLENE GLYCOL 3350 17 g/d 0722-7121_8ba63d22-cb7b-4185-b212-fa1d6b295c8a 0722-7121 HUMAN PRESCRIPTION DRUG Chenodiol Chenodiol TABLET, FILM COATED ORAL 20091001 ANDA ANDA091019 Nexgen Pharma, Inc. CHENODIOL 250 mg/1 0722-7183_b87994ee-26a5-4d00-99e7-796bc17961f1 0722-7183 HUMAN PRESCRIPTION DRUG Mecamylamine Hydrochloride Mecamylamine Hydrochloride TABLET ORAL 20130319 ANDA ANDA204054 Nexgen Pharma, Inc. MECAMYLAMINE HYDROCHLORIDE 2.5 mg/1 Autonomic Ganglionic Blocker [EPC],Decreased Autonomic Ganglionic Activity [PE] 0777-3104_80c8ee6e-5a47-4ecc-b742-6ac5e2f0f00f 0777-3104 HUMAN PRESCRIPTION DRUG Prozac Fluoxetine hydrochloride CAPSULE ORAL 19930113 NDA NDA018936 Dista Products Company FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0777-3105_80c8ee6e-5a47-4ecc-b742-6ac5e2f0f00f 0777-3105 HUMAN PRESCRIPTION DRUG Prozac Fluoxetine hydrochloride CAPSULE ORAL 19880201 NDA NDA018936 Dista Products Company FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0777-3107_80c8ee6e-5a47-4ecc-b742-6ac5e2f0f00f 0777-3107 HUMAN PRESCRIPTION DRUG Prozac Fluoxetine hydrochloride CAPSULE ORAL 19990615 NDA NDA018936 Dista Products Company FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0781-1008_2817a13e-1e33-4429-8eca-78dc1191aa3d 0781-1008 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19880617 ANDA ANDA072011 Sandoz Inc HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-1030_abc79c69-2f26-47df-8ead-b5ffadb62b7c 0781-1030 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride Trifluoperazine Hydrochloride TABLET, FILM COATED ORAL 19811120 ANDA ANDA085785 Sandoz Inc TRIFLUOPERAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1032_abc79c69-2f26-47df-8ead-b5ffadb62b7c 0781-1032 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride Trifluoperazine Hydrochloride TABLET, FILM COATED ORAL 19811120 ANDA ANDA085786 Sandoz Inc TRIFLUOPERAZINE HYDROCHLORIDE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1034_abc79c69-2f26-47df-8ead-b5ffadb62b7c 0781-1034 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride Trifluoperazine Hydrochloride TABLET, FILM COATED ORAL 19811120 ANDA ANDA085789 Sandoz Inc TRIFLUOPERAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1036_abc79c69-2f26-47df-8ead-b5ffadb62b7c 0781-1036 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride Trifluoperazine Hydrochloride TABLET, FILM COATED ORAL 19811120 ANDA ANDA085788 Sandoz Inc TRIFLUOPERAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1046_a6be27a1-466e-4e1c-b7ce-3b3c1c776c06 0781-1046 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 19881208 ANDA ANDA089683 Sandoz Inc PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1047_a6be27a1-466e-4e1c-b7ce-3b3c1c776c06 0781-1047 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 19881208 ANDA ANDA089684 Sandoz Inc PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1048_a6be27a1-466e-4e1c-b7ce-3b3c1c776c06 0781-1048 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 19881208 ANDA ANDA089685 Sandoz Inc PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1049_a6be27a1-466e-4e1c-b7ce-3b3c1c776c06 0781-1049 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 19881208 ANDA ANDA089686 Sandoz Inc PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1053_bcdf8c53-d8f6-4604-b001-f8563f11ece2 0781-1053 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Sandoz Inc BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0781-1061_b1a5ac7c-71d0-4e53-bc06-9597f08d1dad 0781-1061 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Sandoz Inc ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0781-1064_bcdf8c53-d8f6-4604-b001-f8563f11ece2 0781-1064 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Sandoz Inc BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0781-1071_4474945b-2d10-494c-92e3-d783943d2080 0781-1071 HUMAN PRESCRIPTION DRUG Methazolamide Methazolamide TABLET ORAL 19930630 ANDA ANDA040036 Sandoz Inc METHAZOLAMIDE 50 mg/1 0781-1072_4474945b-2d10-494c-92e3-d783943d2080 0781-1072 HUMAN PRESCRIPTION DRUG Methazolamide Methazolamide TABLET ORAL 19930630 ANDA ANDA040036 Sandoz Inc METHAZOLAMIDE 25 mg/1 0781-1077_b1a5ac7c-71d0-4e53-bc06-9597f08d1dad 0781-1077 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Sandoz Inc ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0781-1078_7dcdc8fe-0be2-4cfd-9f35-32db0e55f165 0781-1078 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 ANDA ANDA074052 Sandoz Inc ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0781-1079_b1a5ac7c-71d0-4e53-bc06-9597f08d1dad 0781-1079 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Sandoz Inc ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0781-1089_b1a5ac7c-71d0-4e53-bc06-9597f08d1dad 0781-1089 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19980325 ANDA ANDA074909 Sandoz Inc ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0781-1123_2817a13e-1e33-4429-8eca-78dc1191aa3d 0781-1123 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19920430 ANDA ANDA073281 Sandoz Inc HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-1181_ed2ee5af-c827-4a41-a12e-f9ec3e6a9005 0781-1181 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081001 ANDA ANDA074501 Sandoz Inc NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0781-1182_ed2ee5af-c827-4a41-a12e-f9ec3e6a9005 0781-1182 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081001 ANDA ANDA074501 Sandoz Inc NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0781-1183_ed2ee5af-c827-4a41-a12e-f9ec3e6a9005 0781-1183 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081001 ANDA ANDA074501 Sandoz Inc NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0781-1205_b9e9003b-80ec-4cba-9344-6b53bc7a5684 0781-1205 HUMAN PRESCRIPTION DRUG Penicillin V Potasium Penicillin V Potasium TABLET ORAL 19951130 ANDA ANDA064071 Sandoz Inc PENICILLIN V POTASSIUM 250 mg/1 0781-1223_bc5385c0-9f93-4415-8f56-b0d2c63ad3e5 0781-1223 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 19940325 ANDA ANDA073288 Sandoz Inc METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0781-1228_bc5385c0-9f93-4415-8f56-b0d2c63ad3e5 0781-1228 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 19940325 ANDA ANDA073289 Sandoz Inc METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0781-1345_9250c587-1a02-418b-9f3f-31e9fe00fc5f 0781-1345 HUMAN OTC DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 19890522 OTC MONOGRAPH FINAL part336 Sandoz Inc MECLIZINE HYDROCHLORIDE 12.5 mg/1 0781-1358_0690d8e8-468f-4842-a092-970a315c4d79 0781-1358 HUMAN OTC DRUG Clemastine Fumarate Clemastine Fumarate TABLET ORAL 19931031 ANDA ANDA073458 Sandoz Inc CLEMASTINE FUMARATE 1.34 mg/1 0781-1359_afc66ad6-b22e-44af-b748-359e5594e290 0781-1359 HUMAN PRESCRIPTION DRUG Clemastine Fumarate Clemastine Fumarate TABLET ORAL 19931031 ANDA ANDA073459 Sandoz Inc CLEMASTINE FUMARATE 2.68 mg/1 0781-1375_9250c587-1a02-418b-9f3f-31e9fe00fc5f 0781-1375 HUMAN OTC DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 19890522 OTC MONOGRAPH FINAL part336 Sandoz Inc MECLIZINE HYDROCHLORIDE 25 mg/1 0781-1381_aa6f4f2a-5e51-46b2-8e6d-7846bb84611f 0781-1381 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960308 NDA AUTHORIZED GENERIC NDA020254 Sandoz Inc DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0781-1391_af1654a2-6ffe-451f-962e-cb73403aa976 0781-1391 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071206 Sandoz Inc HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] 0781-1392_af1654a2-6ffe-451f-962e-cb73403aa976 0781-1392 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071207 Sandoz Inc HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] 0781-1393_af1654a2-6ffe-451f-962e-cb73403aa976 0781-1393 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071208 Sandoz Inc HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] 0781-1396_af1654a2-6ffe-451f-962e-cb73403aa976 0781-1396 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071209 Sandoz Inc HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 0781-1397_af1654a2-6ffe-451f-962e-cb73403aa976 0781-1397 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19880311 ANDA ANDA071210 Sandoz Inc HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] 0781-1398_af1654a2-6ffe-451f-962e-cb73403aa976 0781-1398 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19880311 ANDA ANDA071211 Sandoz Inc HALOPERIDOL 20 mg/1 Typical Antipsychotic [EPC] 0781-1407_9d22f0a8-170b-4c3e-8c2e-a5cf64b9958b 0781-1407 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 19951130 ANDA ANDA040104 Sandoz Inc HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 0781-1407_e12a3f5a-6819-4b7d-852e-9283155f6d56 0781-1407 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 19951130 ANDA ANDA040104 Sandoz Inc HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 0781-1436_3b0ecdab-005c-4df2-949a-a4f78dedebb1 0781-1436 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19871016 ANDA ANDA089586 Sandoz Inc FLUPHENAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1437_3b0ecdab-005c-4df2-949a-a4f78dedebb1 0781-1437 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19871016 ANDA ANDA089586 Sandoz Inc FLUPHENAZINE HYDROCHLORIDE 2.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1438_3b0ecdab-005c-4df2-949a-a4f78dedebb1 0781-1438 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19871016 ANDA ANDA089586 Sandoz Inc FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1439_3b0ecdab-005c-4df2-949a-a4f78dedebb1 0781-1439 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19871016 ANDA ANDA089586 Sandoz Inc FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1446_694bd35c-f4b4-4e76-ae9b-a819e2c54e61 0781-1446 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 Sandoz Inc FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0781-1452_da843179-713c-418a-839a-5650009f74e2 0781-1452 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Sandoz Inc GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0781-1453_da843179-713c-418a-839a-5650009f74e2 0781-1453 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Sandoz Inc GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0781-1486_849774fd-1ce8-444d-8c1b-8327ac64b9a1 0781-1486 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 Sandoz Inc AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0781-1487_849774fd-1ce8-444d-8c1b-8327ac64b9a1 0781-1487 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 Sandoz Inc AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0781-1488_849774fd-1ce8-444d-8c1b-8327ac64b9a1 0781-1488 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 Sandoz Inc AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0781-1489_849774fd-1ce8-444d-8c1b-8327ac64b9a1 0781-1489 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085971 Sandoz Inc AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 0781-1490_849774fd-1ce8-444d-8c1b-8327ac64b9a1 0781-1490 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085967 Sandoz Inc AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 0781-1491_849774fd-1ce8-444d-8c1b-8327ac64b9a1 0781-1491 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085970 Sandoz Inc AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 0781-1496_3cc953ff-c3c1-42ef-8b7f-0b4723edfe27 0781-1496 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065211 Sandoz Inc AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0781-1497_8b1ffb43-0b5d-4573-a4e0-5cfad2d3a191 0781-1497 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065209 Sandoz Inc AZITHROMYCIN MONOHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0781-1506_7dcdc8fe-0be2-4cfd-9f35-32db0e55f165 0781-1506 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073025 Sandoz Inc ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0781-1507_7dcdc8fe-0be2-4cfd-9f35-32db0e55f165 0781-1507 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073026 Sandoz Inc ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0781-1516_5e34c90c-d6de-4f4c-a3e6-03e62c145194 0781-1516 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Sandoz Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0781-1526_5e34c90c-d6de-4f4c-a3e6-03e62c145194 0781-1526 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Sandoz Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0781-1556_b1fbb676-be73-40e5-b1b2-ab1707e36bcf 0781-1556 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880107 ANDA ANDA086223 Sandoz Inc ISOSORBIDE DINITRATE 10 mg/1 0781-1599_d6e9037b-3b6f-4997-891d-f69353a6f108 0781-1599 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 19820101 ANDA ANDA086809 Sandoz Inc SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0781-1619_dcd5df1e-0dc7-48e5-bed0-57161b55317e 0781-1619 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, CHEWABLE ORAL 20020418 ANDA ANDA065065 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0781-1619_e01b98fd-1667-47a4-ac2e-4c1ff48e1b4c 0781-1619 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, CHEWABLE ORAL 20020418 ANDA ANDA065065 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0781-1635_b1fbb676-be73-40e5-b1b2-ab1707e36bcf 0781-1635 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880107 ANDA ANDA086221 Sandoz Inc ISOSORBIDE DINITRATE 5 mg/1 0781-1643_dcd5df1e-0dc7-48e5-bed0-57161b55317e 0781-1643 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, CHEWABLE ORAL 20020418 ANDA ANDA065065 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-1643_e01b98fd-1667-47a4-ac2e-4c1ff48e1b4c 0781-1643 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, CHEWABLE ORAL 20020418 ANDA ANDA065065 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0781-1646_a44e613d-ad93-4c82-a7b8-2ac2cf1dc5aa 0781-1646 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 19980218 ANDA ANDA075061 Sandoz Inc NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0781-1653_a44e613d-ad93-4c82-a7b8-2ac2cf1dc5aa 0781-1653 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 19980218 ANDA ANDA075061 Sandoz Inc NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0781-1655_b9e9003b-80ec-4cba-9344-6b53bc7a5684 0781-1655 HUMAN PRESCRIPTION DRUG Penicillin V Potasium Penicillin V Potasium TABLET ORAL 19951130 ANDA ANDA064071 Sandoz Inc PENICILLIN V POTASSIUM 500 mg/1 0781-1679_b2fff8af-25b8-45b9-a8db-01cb73108c73 0781-1679 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077517 Sandoz Inc ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0781-1681_b2fff8af-25b8-45b9-a8db-01cb73108c73 0781-1681 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077517 Sandoz Inc ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0781-1683_abb8f747-037b-410c-8bdf-7115cfa741e9 0781-1683 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077946 Sandoz Inc CETIRIZINE HYDROCHLORIDE 5 mg/1 0781-1684_9b27ceca-79b8-4bab-be48-e0e4197d9a1e 0781-1684 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077946 Sandoz Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 0781-1695_b1fbb676-be73-40e5-b1b2-ab1707e36bcf 0781-1695 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880407 ANDA ANDA089367 Sandoz Inc ISOSORBIDE DINITRATE 20 mg/1 0781-1715_a11a65a4-0352-4b19-be28-9542e3dd8e69 0781-1715 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, FILM COATED ORAL 19730103 ANDA ANDA080439 Sandoz Inc CHLORPROMAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1716_a11a65a4-0352-4b19-be28-9542e3dd8e69 0781-1716 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, FILM COATED ORAL 19730103 ANDA ANDA080439 Sandoz Inc CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1717_a11a65a4-0352-4b19-be28-9542e3dd8e69 0781-1717 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, FILM COATED ORAL 19730103 ANDA ANDA080439 Sandoz Inc CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1718_a11a65a4-0352-4b19-be28-9542e3dd8e69 0781-1718 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, FILM COATED ORAL 19730103 ANDA ANDA080439 Sandoz Inc CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1719_a11a65a4-0352-4b19-be28-9542e3dd8e69 0781-1719 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, FILM COATED ORAL 19730103 ANDA ANDA080439 Sandoz Inc CHLORPROMAZINE HYDROCHLORIDE 200 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1750_a912c67a-7589-4c54-8c4b-19b3028da301 0781-1750 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19811231 ANDA ANDA084615 Sandoz Inc METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0781-1760_a912c67a-7589-4c54-8c4b-19b3028da301 0781-1760 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19811231 ANDA ANDA084616 Sandoz Inc METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0781-1762_f7dd140b-5b38-4f13-9baf-5c57460c78bb 0781-1762 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19760420 ANDA ANDA084936 Sandoz Inc IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0781-1764_f7dd140b-5b38-4f13-9baf-5c57460c78bb 0781-1764 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19760420 ANDA ANDA083745 Sandoz Inc IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0781-1766_f7dd140b-5b38-4f13-9baf-5c57460c78bb 0781-1766 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19760420 ANDA ANDA084937 Sandoz Inc IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0781-1785_cb84a245-7f02-48f4-a26c-0609097104a2 0781-1785 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19950928 ANDA ANDA074376 Sandoz Inc DICLOFENAC SODIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0781-1787_cb84a245-7f02-48f4-a26c-0609097104a2 0781-1787 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19950928 ANDA ANDA074376 Sandoz Inc DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0781-1789_cb84a245-7f02-48f4-a26c-0609097104a2 0781-1789 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19951130 ANDA ANDA074394 Sandoz Inc DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0781-1818_694bd35c-f4b4-4e76-ae9b-a819e2c54e61 0781-1818 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 Sandoz Inc FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0781-1830_307623c2-cfde-453e-9e76-59349d909a26 0781-1830 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19751219 ANDA ANDA084176 Sandoz Inc PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1831_dcd5df1e-0dc7-48e5-bed0-57161b55317e 0781-1831 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20020315 ANDA ANDA065064 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0781-1832_307623c2-cfde-453e-9e76-59349d909a26 0781-1832 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19750218 ANDA ANDA084176 Sandoz Inc PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-1852_dcd5df1e-0dc7-48e5-bed0-57161b55317e 0781-1852 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20020314 ANDA ANDA065063 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0781-1874_dcd5df1e-0dc7-48e5-bed0-57161b55317e 0781-1874 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20050823 ANDA ANDA065189 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0781-1883_97c5cff1-e9a3-420d-a34c-118758ef2a14 0781-1883 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET, FILM COATED ORAL 19970829 ANDA ANDA074467 Sandoz Inc RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0781-1884_97c5cff1-e9a3-420d-a34c-118758ef2a14 0781-1884 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET, FILM COATED ORAL 19970829 ANDA ANDA074467 Sandoz Inc RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0781-1941_3cc953ff-c3c1-42ef-8b7f-0b4723edfe27 0781-1941 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065212 Sandoz Inc AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0781-1943_85a0fcc4-99cf-446f-861d-fe169fc7171d 0781-1943 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, MULTILAYER, EXTENDED RELEASE ORAL 20100421 ANDA ANDA090227 Sandoz Inc AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM 562.5; 437.5; 62.5 mg/1; mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0781-1961_688ddf7f-09be-4656-a988-9f624a42992e 0781-1961 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20051018 ANDA ANDA065144 Sandoz Inc CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0781-1962_688ddf7f-09be-4656-a988-9f624a42992e 0781-1962 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20050825 ANDA ANDA065136 Sandoz Inc CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0781-1966_694bd35c-f4b4-4e76-ae9b-a819e2c54e61 0781-1966 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 Sandoz Inc FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0781-1971_0face5ef-d969-49d3-a27b-eab3ad4cee53 0781-1971 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880524 ANDA ANDA072099 Sandoz Inc DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0781-1972_0face5ef-d969-49d3-a27b-eab3ad4cee53 0781-1972 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880524 ANDA ANDA072100 Sandoz Inc DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0781-1973_0face5ef-d969-49d3-a27b-eab3ad4cee53 0781-1973 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880524 ANDA ANDA072101 Sandoz Inc DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0781-1974_0face5ef-d969-49d3-a27b-eab3ad4cee53 0781-1974 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880620 ANDA ANDA072102 Sandoz Inc DESIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 0781-1975_0face5ef-d969-49d3-a27b-eab3ad4cee53 0781-1975 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880620 ANDA ANDA072103 Sandoz Inc DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 0781-1976_0face5ef-d969-49d3-a27b-eab3ad4cee53 0781-1976 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880620 ANDA ANDA072104 Sandoz Inc DESIPRAMINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 0781-2020_fa7c7427-a6b2-4b4b-b9b0-3dcafacd375e 0781-2020 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19940930 ANDA ANDA064076 Sandoz Inc AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-2027_ca1865db-d006-4946-af3f-7ffbd9f840a8 0781-2027 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 19960329 ANDA ANDA074364 Sandoz Inc CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0781-2037_ca1865db-d006-4946-af3f-7ffbd9f840a8 0781-2037 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 19960329 ANDA ANDA074364 Sandoz Inc CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0781-2043_684f45d1-a394-49a0-9114-ab6e6220bb97 0781-2043 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin CAPSULE ORAL 20040406 ANDA ANDA076192 Sandoz Inc RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 0781-2047_ca1865db-d006-4946-af3f-7ffbd9f840a8 0781-2047 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 19960329 ANDA ANDA074364 Sandoz Inc CLOMIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 0781-2048_c774607f-88ef-4af8-82b3-d3a27f15ad60 0781-2048 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19870218 ANDA ANDA071293 Sandoz Inc AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 0781-2051_b8cbeb41-7cc5-4a47-b905-bc0a973d9478 0781-2051 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 19980330 ANDA ANDA074823 Sandoz Inc TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0781-2052_b8cbeb41-7cc5-4a47-b905-bc0a973d9478 0781-2052 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 19980330 ANDA ANDA074823 Sandoz Inc TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0781-2053_b8cbeb41-7cc5-4a47-b905-bc0a973d9478 0781-2053 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 19980330 ANDA ANDA074823 Sandoz Inc TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0781-2054_b8cbeb41-7cc5-4a47-b905-bc0a973d9478 0781-2054 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 19980330 ANDA ANDA074823 Sandoz Inc TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0781-2067_0e46e04e-7874-48df-ba4b-aad69707b854 0781-2067 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20081015 ANDA ANDA065379 Sandoz Inc MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 0781-2074_a8c9ccef-b3b6-4ba1-9dab-d889ec7a1f16 0781-2074 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 19970605 ANDA ANDA074821 Sandoz Inc HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-2076_41c5daad-b7b4-49b8-b990-6845df708b96 0781-2076 HUMAN PRESCRIPTION DRUG tamsulosin hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078015 Sandoz Inc TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0781-2081_8c973fd1-17a6-11e4-8c21-0800200c9a66 0781-2081 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20120314 NDA AUTHORIZED GENERIC NDA021160 Sandoz Inc CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0781-2102_bc4cec00-212a-41b8-b74b-a12d23c752c0 0781-2102 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20090810 ANDA ANDA065461 Sandoz Inc TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0781-2103_bc4cec00-212a-41b8-b74b-a12d23c752c0 0781-2103 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20090810 ANDA ANDA065461 Sandoz Inc TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0781-2104_bc4cec00-212a-41b8-b74b-a12d23c752c0 0781-2104 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20090810 ANDA ANDA065461 Sandoz Inc TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0781-2144_0a66c5c3-63bf-46e3-835e-26b555ab6954 0781-2144 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 19950829 ANDA ANDA064082 Sandoz Inc AMPICILLIN TRIHYDRATE 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-2145_0a66c5c3-63bf-46e3-835e-26b555ab6954 0781-2145 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 19950829 ANDA ANDA064082 Sandoz Inc AMPICILLIN TRIHYDRATE 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-2147_b34ce263-17cd-444d-8b23-c2ad919e05ac 0781-2147 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20100423 ANDA ANDA090331 Sandoz Inc LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0781-2148_b34ce263-17cd-444d-8b23-c2ad919e05ac 0781-2148 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20100423 ANDA ANDA090331 Sandoz Inc LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0781-2164_0d763aa4-bc18-430a-baa1-266b6849d534 0781-2164 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130213 ANDA ANDA077562 Sandoz Inc ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 0781-2166_0d763aa4-bc18-430a-baa1-266b6849d534 0781-2166 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130213 ANDA ANDA077562 Sandoz Inc ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 0781-2167_0d763aa4-bc18-430a-baa1-266b6849d534 0781-2167 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130213 ANDA ANDA077562 Sandoz Inc ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 0781-2168_0d763aa4-bc18-430a-baa1-266b6849d534 0781-2168 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130213 ANDA ANDA077562 Sandoz Inc ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 0781-2176_ed3d8e07-8e12-4bf9-b58c-17067216c57c 0781-2176 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20070406 ANDA ANDA065330 Sandoz Inc CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-2191_6711e17e-7a4a-4ee2-b494-6e3bc94f6dd7 0781-2191 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20121130 ANDA ANDA078901 Sandoz Inc FLUOXETINE HYDROCHLORIDE; OLANZAPINE 25; 6 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0781-2192_6711e17e-7a4a-4ee2-b494-6e3bc94f6dd7 0781-2192 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20121130 ANDA ANDA078901 Sandoz Inc FLUOXETINE HYDROCHLORIDE; OLANZAPINE 25; 12 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0781-2193_6711e17e-7a4a-4ee2-b494-6e3bc94f6dd7 0781-2193 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20121130 ANDA ANDA078901 Sandoz Inc FLUOXETINE HYDROCHLORIDE; OLANZAPINE 50; 6 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0781-2194_6711e17e-7a4a-4ee2-b494-6e3bc94f6dd7 0781-2194 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20121130 ANDA ANDA078901 Sandoz Inc FLUOXETINE HYDROCHLORIDE; OLANZAPINE 50; 12 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0781-2195_6711e17e-7a4a-4ee2-b494-6e3bc94f6dd7 0781-2195 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20121130 ANDA ANDA078901 Sandoz Inc FLUOXETINE HYDROCHLORIDE; OLANZAPINE 25; 3 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0781-2201_a3791c97-8b7b-4250-827d-4934cf3e735a 0781-2201 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19880112 ANDA ANDA071427 Sandoz Inc TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0781-2202_a3791c97-8b7b-4250-827d-4934cf3e735a 0781-2202 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19880112 ANDA ANDA071428 Sandoz Inc TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0781-2226_b8c56a07-4ca0-48d2-9834-784c85b60fc2 0781-2226 HUMAN PRESCRIPTION DRUG Thiothixene Thiothixene CAPSULE ORAL 19870624 ANDA ANDA071610 Sandoz Inc THIOTHIXENE 1 mg/1 Typical Antipsychotic [EPC] 0781-2227_b8c56a07-4ca0-48d2-9834-784c85b60fc2 0781-2227 HUMAN PRESCRIPTION DRUG Thiothixene Thiothixene CAPSULE ORAL 19870624 ANDA ANDA071570 Sandoz Inc THIOTHIXENE 2 mg/1 Typical Antipsychotic [EPC] 0781-2228_b8c56a07-4ca0-48d2-9834-784c85b60fc2 0781-2228 HUMAN PRESCRIPTION DRUG Thiothixene Thiothixene CAPSULE ORAL 19870624 ANDA ANDA071529 Sandoz Inc THIOTHIXENE 5 mg/1 Typical Antipsychotic [EPC] 0781-2229_b8c56a07-4ca0-48d2-9834-784c85b60fc2 0781-2229 HUMAN PRESCRIPTION DRUG Thiothixene Thiothixene CAPSULE ORAL 19870624 ANDA ANDA071530 Sandoz Inc THIOTHIXENE 10 mg/1 Typical Antipsychotic [EPC] 0781-2232_30dcbf11-178f-4e0a-8509-976dd3e2fca9 0781-2232 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20030128 ANDA ANDA075757 Sandoz Inc OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0781-2233_30dcbf11-178f-4e0a-8509-976dd3e2fca9 0781-2233 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20030128 ANDA ANDA075757 Sandoz Inc OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0781-2234_30dcbf11-178f-4e0a-8509-976dd3e2fca9 0781-2234 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA076515 Sandoz Inc OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0781-2248_51d81082-3f8e-4be9-8aa6-2d54c785f076 0781-2248 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19710401 ANDA ANDA061454 Sandoz Inc DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-2258_51d81082-3f8e-4be9-8aa6-2d54c785f076 0781-2258 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19710401 ANDA ANDA061454 Sandoz Inc DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-2260_6b194d5b-7326-4baf-9e5a-d9ada2f369ca 0781-2260 HUMAN PRESCRIPTION DRUG Atomoxetine hydrochloride Atomoxetine hydrochloride CAPSULE ORAL 20101215 ANDA ANDA079018 Sandoz Inc ATOMOXETINE HYDROCHLORIDE 10 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 0781-2261_6b194d5b-7326-4baf-9e5a-d9ada2f369ca 0781-2261 HUMAN PRESCRIPTION DRUG Atomoxetine hydrochloride Atomoxetine hydrochloride CAPSULE ORAL 20101215 ANDA ANDA079018 Sandoz Inc ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 0781-2262_6b194d5b-7326-4baf-9e5a-d9ada2f369ca 0781-2262 HUMAN PRESCRIPTION DRUG Atomoxetine hydrochloride Atomoxetine hydrochloride CAPSULE ORAL 20101215 ANDA ANDA079018 Sandoz Inc ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 0781-2263_6b194d5b-7326-4baf-9e5a-d9ada2f369ca 0781-2263 HUMAN PRESCRIPTION DRUG Atomoxetine hydrochloride Atomoxetine hydrochloride CAPSULE ORAL 20101215 ANDA ANDA079018 Sandoz Inc ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 0781-2264_6b194d5b-7326-4baf-9e5a-d9ada2f369ca 0781-2264 HUMAN PRESCRIPTION DRUG Atomoxetine hydrochloride Atomoxetine hydrochloride CAPSULE ORAL 20101215 ANDA ANDA079018 Sandoz Inc ATOMOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 0781-2265_6b194d5b-7326-4baf-9e5a-d9ada2f369ca 0781-2265 HUMAN PRESCRIPTION DRUG Atomoxetine hydrochloride Atomoxetine hydrochloride CAPSULE ORAL 20101215 ANDA ANDA079018 Sandoz Inc ATOMOXETINE HYDROCHLORIDE 80 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 0781-2266_6b194d5b-7326-4baf-9e5a-d9ada2f369ca 0781-2266 HUMAN PRESCRIPTION DRUG Atomoxetine hydrochloride Atomoxetine hydrochloride CAPSULE ORAL 20101215 ANDA ANDA079018 Sandoz Inc ATOMOXETINE HYDROCHLORIDE 100 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 0781-2271_ee885922-cc1f-4cf5-89ff-43714520d1fa 0781-2271 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Sandoz Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0781-2272_ee885922-cc1f-4cf5-89ff-43714520d1fa 0781-2272 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Sandoz Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0781-2273_ee885922-cc1f-4cf5-89ff-43714520d1fa 0781-2273 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Sandoz Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0781-2274_ee885922-cc1f-4cf5-89ff-43714520d1fa 0781-2274 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Sandoz Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0781-2277_ee885922-cc1f-4cf5-89ff-43714520d1fa 0781-2277 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Sandoz Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0781-2279_ee885922-cc1f-4cf5-89ff-43714520d1fa 0781-2279 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Sandoz Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0781-2325_4a6cd6dc-d3bd-458a-a02e-19ac3dbccf75 0781-2325 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 19870429 ANDA ANDA070673 Sandoz Inc INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0781-2350_4a6cd6dc-d3bd-458a-a02e-19ac3dbccf75 0781-2350 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 19870429 ANDA ANDA070674 Sandoz Inc INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0781-2452_19b22a02-eab2-4b43-9f08-c127e321fc69 0781-2452 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 ANDA ANDA091022 Sandoz Inc DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0781-2453_19b22a02-eab2-4b43-9f08-c127e321fc69 0781-2453 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 ANDA ANDA091022 Sandoz Inc DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0781-2454_19b22a02-eab2-4b43-9f08-c127e321fc69 0781-2454 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 ANDA ANDA091022 Sandoz Inc DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0781-2455_19b22a02-eab2-4b43-9f08-c127e321fc69 0781-2455 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 ANDA ANDA091022 Sandoz Inc DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0781-2456_19b22a02-eab2-4b43-9f08-c127e321fc69 0781-2456 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 ANDA ANDA091022 Sandoz Inc DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0781-2457_19b22a02-eab2-4b43-9f08-c127e321fc69 0781-2457 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 ANDA ANDA091022 Sandoz Inc DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0781-2613_fa7c7427-a6b2-4b4b-b9b0-3dcafacd375e 0781-2613 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19940930 ANDA ANDA064076 Sandoz Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-2614_3375f1a6-a261-4c5c-81ee-674a11cefaf8 0781-2614 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate rivastigmine tartrate CAPSULE ORAL 20000430 NDA AUTHORIZED GENERIC NDA020823 Sandoz Inc RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0781-2615_3375f1a6-a261-4c5c-81ee-674a11cefaf8 0781-2615 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate rivastigmine tartrate CAPSULE ORAL 20000430 NDA AUTHORIZED GENERIC NDA020823 Sandoz Inc RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0781-2616_3375f1a6-a261-4c5c-81ee-674a11cefaf8 0781-2616 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate rivastigmine tartrate CAPSULE ORAL 20000430 NDA AUTHORIZED GENERIC NDA020823 Sandoz Inc RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0781-2617_3375f1a6-a261-4c5c-81ee-674a11cefaf8 0781-2617 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate rivastigmine tartrate CAPSULE ORAL 20000430 NDA AUTHORIZED GENERIC NDA020823 Sandoz Inc RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0781-2672_8c973fd1-17a6-11e4-8c21-0800200c9a66 0781-2672 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20120314 NDA AUTHORIZED GENERIC NDA021160 Sandoz Inc CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 0781-2684_5553509b-fb2e-40c3-a649-b884dfa5576b 0781-2684 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140128 NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0781-2687_5553509b-fb2e-40c3-a649-b884dfa5576b 0781-2687 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140102 NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0781-2689_5553509b-fb2e-40c3-a649-b884dfa5576b 0781-2689 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140304 NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0781-2691_80ea7838-5a97-4cd0-958c-5916908d4406 0781-2691 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 NDA AUTHORIZED GENERIC NDA021029 Sandoz Inc. TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0781-2692_80ea7838-5a97-4cd0-958c-5916908d4406 0781-2692 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 NDA AUTHORIZED GENERIC NDA021029 Sandoz Inc. TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0781-2693_80ea7838-5a97-4cd0-958c-5916908d4406 0781-2693 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 NDA AUTHORIZED GENERIC NDA021029 Sandoz Inc. TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0781-2694_80ea7838-5a97-4cd0-958c-5916908d4406 0781-2694 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 NDA AUTHORIZED GENERIC NDA021029 Sandoz Inc. TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0781-2695_80ea7838-5a97-4cd0-958c-5916908d4406 0781-2695 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 NDA AUTHORIZED GENERIC NDA021029 Sandoz Inc. TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0781-2696_80ea7838-5a97-4cd0-958c-5916908d4406 0781-2696 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 NDA AUTHORIZED GENERIC NDA021029 Sandoz Inc. TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 0781-2715_a8c9ccef-b3b6-4ba1-9dab-d889ec7a1f16 0781-2715 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 19910731 ANDA ANDA073191 Sandoz Inc HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-2809_32b4c023-bca7-4f73-8f79-4371d3b7307b 0781-2809 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE ORAL 19880419 ANDA ANDA071813 Sandoz Inc OXAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0781-2810_32b4c023-bca7-4f73-8f79-4371d3b7307b 0781-2810 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE ORAL 19880419 ANDA ANDA071756 Sandoz Inc OXAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0781-2811_32b4c023-bca7-4f73-8f79-4371d3b7307b 0781-2811 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE ORAL 19880419 ANDA ANDA071814 Sandoz Inc OXAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0781-2822_9f2e4d22-0766-4c8b-83e3-1e4d0fa71bc9 0781-2822 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20020129 ANDA ANDA075049 Sandoz Inc FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0781-2823_9f2e4d22-0766-4c8b-83e3-1e4d0fa71bc9 0781-2823 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20010802 ANDA ANDA075049 Sandoz Inc FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0781-2824_9f2e4d22-0766-4c8b-83e3-1e4d0fa71bc9 0781-2824 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20020129 ANDA ANDA075049 Sandoz Inc FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0781-2855_97c5cff1-e9a3-420d-a34c-118758ef2a14 0781-2855 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride CAPSULE ORAL 19971022 ANDA ANDA074655 Sandoz Inc RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0781-2865_97c5cff1-e9a3-420d-a34c-118758ef2a14 0781-2865 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride CAPSULE ORAL 19971022 ANDA ANDA074655 Sandoz Inc RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0781-2938_f2fe2c06-e1d9-4f75-82cf-0449f2d12396 0781-2938 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 19800730 ANDA ANDA062291 Sandoz Inc CEFADROXIL 500 mg/1 0781-3001_27a5c992-5724-4ed9-a72c-d7d7e1953fc9 0781-3001 HUMAN PRESCRIPTION DRUG Omnitrope Somatropin INJECTION, SOLUTION SUBCUTANEOUS 20060530 NDA NDA021426 Sandoz Inc SOMATROPIN 5 mg/1.5mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] 0781-3003_37418d42-f4fc-4f86-a9d2-4b33b85c4460 0781-3003 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION INTRAVENOUS 20050503 ANDA ANDA077071 Sandoz Inc FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 0781-3004_27a5c992-5724-4ed9-a72c-d7d7e1953fc9 0781-3004 HUMAN PRESCRIPTION DRUG Omnitrope Somatropin INJECTION, SOLUTION SUBCUTANEOUS 20060530 NDA NDA021426 Sandoz Inc SOMATROPIN 10 mg/1.5mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] 0781-3005_599ec9d1-281f-4693-b9a0-9778df41ae15 0781-3005 HUMAN PRESCRIPTION DRUG Fenoldopam Mesylate Fenoldopam Mesylate INJECTION, SOLUTION INTRAVENOUS 20050215 ANDA ANDA077155 Sandoz Inc FENOLDOPAM MESYLATE 10 mg/mL Dopamine Agonists [MoA],Dopaminergic Agonist [EPC] 0781-3009_086a7742-5f8c-4127-a488-56a1cd245331 0781-3009 HUMAN PRESCRIPTION DRUG Anectine Succinylcholine Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 19520820 NDA NDA008453 Sandoz Inc SUCCINYLCHOLINE CHLORIDE 20 mg/mL Depolarizing Neuromuscular Blocker [EPC],Neuromuscular Depolarizing Blockade [PE] 0781-3010_ae6721c6-027f-4855-a1ca-387c19422718 0781-3010 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070627 ANDA ANDA077551 Sandoz Inc ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0781-3032_3910e8e0-4a99-4f00-8cfe-80eb89758669 0781-3032 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and Sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060725 ANDA ANDA065241 Sandoz Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0781-3033_3910e8e0-4a99-4f00-8cfe-80eb89758669 0781-3033 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and Sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060725 ANDA ANDA065241 Sandoz Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0781-3034_53a4e503-2f2d-4803-8e86-80ab131d4c6e 0781-3034 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and Sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060725 ANDA ANDA065240 Sandoz Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 10; 5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 0781-3040_44da988e-5709-4647-a578-ad7935601c7e 0781-3040 HUMAN PRESCRIPTION DRUG Regonol Pyridostigmine Bromide INJECTION, SOLUTION INTRAVENOUS; PARENTERAL 20050510 NDA NDA017398 Sandoz Inc PYRIDOSTIGMINE BROMIDE 5 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0781-3056_26023d2e-43e8-47af-b274-deca26ddc0b8 0781-3056 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid INJECTION, SOLUTION INTRAMUSCULAR 20060119 ANDA ANDA040648 Sandoz Inc ISONIAZID 100 mg/mL Antimycobacterial [EPC] 0781-3059_d8fa415f-c20d-4703-932b-4f9f00b6f23a 0781-3059 HUMAN PRESCRIPTION DRUG Digoxin Digoxin INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 20030821 ANDA ANDA040481 Sandoz Inc DIGOXIN 250 ug/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0781-3071_5ea5385d-b3d3-4a67-a39a-ba24a4367ac6 0781-3071 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 20071002 ANDA ANDA077360 Sandoz Inc METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0781-3073_8b94d56b-2f20-4f06-9d0a-544265552fb7 0781-3073 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20060810 ANDA ANDA040615 Sandoz Inc TESTOSTERONE CYPIONATE 100 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0781-3074_8b94d56b-2f20-4f06-9d0a-544265552fb7 0781-3074 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20060810 ANDA ANDA040615 Sandoz Inc TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0781-3084_c5bf372c-d304-4300-9d94-1211cd723e96 0781-3084 HUMAN PRESCRIPTION DRUG Aristospan Triamcinolone Hexacetonide INJECTION, SUSPENSION INTRALESIONAL; PARENTERAL 19690729 NDA NDA016466 Sandoz Inc TRIAMCINOLONE HEXACETONIDE 5 mg/mL 0781-3085_ad853754-f9ab-493f-b13d-4e717be20d18 0781-3085 HUMAN PRESCRIPTION DRUG Aristospan Triamcinolone Hexacetonide INJECTION, SUSPENSION INTRA-ARTICULAR; PARENTERAL 19690729 NDA NDA016466 Sandoz Inc TRIAMCINOLONE HEXACETONIDE 20 mg/mL 0781-3094_0a439e9c-2777-4942-94aa-41a54a6da92e 0781-3094 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19861223 ANDA ANDA062737 Sandoz Inc OXACILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3095_0a439e9c-2777-4942-94aa-41a54a6da92e 0781-3095 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19861223 ANDA ANDA062737 Sandoz Inc OXACILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3099_15c9f48a-ee5f-491d-9790-58e97292713f 0781-3099 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19760106 ANDA ANDA061490 Sandoz Inc OXACILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3101_15c9f48a-ee5f-491d-9790-58e97292713f 0781-3101 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19760106 ANDA ANDA061490 Sandoz Inc OXACILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3103_0fe5d798-6e06-4396-8238-0ea5c2de9ffc 0781-3103 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19910509 ANDA ANDA061490 Sandoz Inc OXACILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3110_8bf072fc-825f-4f88-8e59-07500141b41f 0781-3110 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065362 Sandoz Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0781-3113_8bf072fc-825f-4f88-8e59-07500141b41f 0781-3113 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065362 Sandoz Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0781-3114_8bf072fc-825f-4f88-8e59-07500141b41f 0781-3114 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065362 Sandoz Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0781-3119_9d04cfb1-e417-4c01-a2ee-70a5080787ca 0781-3119 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Sandoz Inc ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0781-3121_9d04cfb1-e417-4c01-a2ee-70a5080787ca 0781-3121 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Sandoz Inc ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0781-3122_28b7b493-7bf9-40e4-be7f-3d1d52b64b87 0781-3122 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20120423 ANDA ANDA078660 Sandoz Inc ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0781-3124_6084b270-177c-4f97-8954-505610ab9d36 0781-3124 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19840802 ANDA ANDA062527 Sandoz Inc NAFCILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3125_6084b270-177c-4f97-8954-505610ab9d36 0781-3125 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19840802 ANDA ANDA062527 Sandoz Inc NAFCILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3126_6e1a1333-4ab2-4b46-89c7-d8547e22ff32 0781-3126 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19840802 ANDA ANDA062527 Sandoz Inc NAFCILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3128_0905fe3e-961d-4f58-b0b7-cc19a4a55af6 0781-3128 HUMAN PRESCRIPTION DRUG Nafcillin Sodium Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050923 ANDA ANDA062732 Sandoz Inc NAFCILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3129_0905fe3e-961d-4f58-b0b7-cc19a4a55af6 0781-3129 HUMAN PRESCRIPTION DRUG Nafcillin Sodium Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050923 ANDA ANDA062732 Sandoz Inc NAFCILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3131_7b4e3280-2181-4cde-a5fa-e0caf53417a0 0781-3131 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; PARENTERAL; SOFT TISSUE 20090305 ANDA ANDA040794 Sandoz Inc METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0781-3132_7b4e3280-2181-4cde-a5fa-e0caf53417a0 0781-3132 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; PARENTERAL; SOFT TISSUE 20090305 ANDA ANDA040794 Sandoz Inc METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0781-3133_28b7b493-7bf9-40e4-be7f-3d1d52b64b87 0781-3133 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Sandoz Inc ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0781-3136_cf85fb08-0e09-4b6b-b151-7cb8b542d31d 0781-3136 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 20090129 ANDA ANDA040719 Sandoz Inc METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0781-3137_cf85fb08-0e09-4b6b-b151-7cb8b542d31d 0781-3137 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 20090129 ANDA ANDA040719 Sandoz Inc METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0781-3139_0b9599e8-9018-42ee-b247-e2a944c36510 0781-3139 HUMAN PRESCRIPTION DRUG Decitabine Decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140828 ANDA ANDA202969 Sandoz Inc DECITABINE 50 mg/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0781-3140_b48c183c-69f9-411c-a27b-9e31b3876ede 0781-3140 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride Ropivacaine Hydrochloride INJECTION, SOLUTION PARENTERAL 20140724 ANDA ANDA078601 Sandoz Inc ROPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0781-3142_b48c183c-69f9-411c-a27b-9e31b3876ede 0781-3142 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride Ropivacaine Hydrochloride INJECTION, SOLUTION PARENTERAL 20140724 ANDA ANDA078601 Sandoz Inc ROPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 0781-3150_efc2e2c8-9024-4a81-a974-ec08b7de7663 0781-3150 HUMAN PRESCRIPTION DRUG cisatracurium besylate cisatracurium besylate INJECTION INTRAVENOUS 20120716 ANDA ANDA200154 Sandoz Inc CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0781-3152_31ff1ec2-1f50-4da7-947b-4a8d1803155b 0781-3152 HUMAN PRESCRIPTION DRUG cisatracurium besylate cisatracurium besylate INJECTION INTRAVENOUS 20120716 ANDA ANDA200159 Sandoz Inc CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0781-3153_efc2e2c8-9024-4a81-a974-ec08b7de7663 0781-3153 HUMAN PRESCRIPTION DRUG cisatracurium besylate cisatracurium besylate INJECTION INTRAVENOUS 20120716 ANDA ANDA200154 Sandoz Inc CISATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0781-3159_1e9666ef-4271-4834-8496-ccb3125d83db 0781-3159 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20111024 ANDA ANDA201588 Sandoz Inc OLANZAPINE 10 mg/2mL Atypical Antipsychotic [EPC] 0781-3164_b02b276f-9007-4ec7-8bcd-40f14213d7f5 0781-3164 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19881021 NDA NDA019667 Sandoz Inc OCTREOTIDE ACETATE 1000 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 0781-3165_b02b276f-9007-4ec7-8bcd-40f14213d7f5 0781-3165 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19881021 NDA NDA019667 Sandoz Inc OCTREOTIDE ACETATE 200 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 0781-3166_4e5348ae-d032-4eea-babc-2cc54c66616e 0781-3166 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140204 NDA AUTHORIZED GENERIC NDA019667 Sandoz Inc OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 0781-3167_4e5348ae-d032-4eea-babc-2cc54c66616e 0781-3167 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140204 NDA AUTHORIZED GENERIC NDA019667 Sandoz Inc OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 0781-3168_4e5348ae-d032-4eea-babc-2cc54c66616e 0781-3168 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140204 NDA AUTHORIZED GENERIC NDA019667 Sandoz Inc OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 0781-3169_2f09006f-335a-4d78-b56b-f08384e150fd 0781-3169 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTION, SOLUTION SUBCUTANEOUS 20120112 NDA NDA020080 Sandoz Inc SUMATRIPTAN SUCCINATE 4 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0781-3170_2f09006f-335a-4d78-b56b-f08384e150fd 0781-3170 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTION, SOLUTION SUBCUTANEOUS 20120112 NDA NDA020080 Sandoz Inc SUMATRIPTAN SUCCINATE 4 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0781-3172_2f09006f-335a-4d78-b56b-f08384e150fd 0781-3172 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTION, SOLUTION SUBCUTANEOUS 20120112 NDA NDA020080 Sandoz Inc SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0781-3173_2f09006f-335a-4d78-b56b-f08384e150fd 0781-3173 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTION, SOLUTION SUBCUTANEOUS 20080909 NDA NDA020080 Sandoz Inc SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0781-3174_2f09006f-335a-4d78-b56b-f08384e150fd 0781-3174 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTION, SOLUTION SUBCUTANEOUS 20080909 NDA NDA020080 Sandoz Inc SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0781-3177_3314efbc-4543-4796-a38c-999ad2fa1758 0781-3177 HUMAN PRESCRIPTION DRUG Ceftazidime Ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080515 ANDA ANDA062640 Sandoz Inc CEFTAZIDIME 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-3178_3314efbc-4543-4796-a38c-999ad2fa1758 0781-3178 HUMAN PRESCRIPTION DRUG Ceftazidime Ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080515 ANDA ANDA062640 Sandoz Inc CEFTAZIDIME 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-3179_bd655f2b-0e2e-47b4-a737-7f7e906b091b 0781-3179 HUMAN PRESCRIPTION DRUG Ceftazidime Ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080515 ANDA ANDA062640 Sandoz Inc CEFTAZIDIME 200 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-3182_a306cd11-9acf-45f1-91ec-9fef2b08fdb1 0781-3182 HUMAN PRESCRIPTION DRUG fomepizole fomepizole INJECTION, SOLUTION INTRAVENOUS 20080306 ANDA ANDA078537 Sandoz Inc. FOMEPIZOLE 1 g/mL Antidote [EPC] 0781-3187_1f7f3d62-c620-4b6b-98f6-3bdce37f453f 0781-3187 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100427 ANDA ANDA090250 Sandoz Inc VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0781-3188_1f7f3d62-c620-4b6b-98f6-3bdce37f453f 0781-3188 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100427 ANDA ANDA090250 Sandoz Inc VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 0781-3204_547aacb1-dd90-4934-80ff-6b3db422175a 0781-3204 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION INTRAVENOUS 20091117 ANDA ANDA090125 Sandoz Inc. NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0781-3206_09e4fe38-4752-4f73-b29d-e1f360843b90 0781-3206 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Sandoz Inc CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-3207_09e4fe38-4752-4f73-b29d-e1f360843b90 0781-3207 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Sandoz Inc CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-3208_09e4fe38-4752-4f73-b29d-e1f360843b90 0781-3208 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Sandoz Inc CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-3209_09e4fe38-4752-4f73-b29d-e1f360843b90 0781-3209 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Sandoz Inc CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-3210_d1c18be8-1408-4c0e-832d-dfecbe76c856 0781-3210 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050517 ANDA ANDA065168 Sandoz Inc CEFTRIAXONE SODIUM 10 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-3220_2e527334-2716-4cb1-ad0b-98a6f73a3bc4 0781-3220 HUMAN PRESCRIPTION DRUG Rocuronium Bromide Rocuronium Bromide INJECTION, SOLUTION INTRAVENOUS 20081205 ANDA ANDA079195 Sandoz Inc ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0781-3222_a1c35106-f505-4ee3-9435-99e2acea0c09 0781-3222 HUMAN PRESCRIPTION DRUG Cefepime Hydrochloride Cefepime Hydrochloride INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080501 ANDA ANDA065441 Sandoz Inc CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-3223_a1c35106-f505-4ee3-9435-99e2acea0c09 0781-3223 HUMAN PRESCRIPTION DRUG Cefepime Hydrochloride Cefepime Hydrochloride INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080501 ANDA ANDA065441 Sandoz Inc CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-3224_28b7b493-7bf9-40e4-be7f-3d1d52b64b87 0781-3224 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Sandoz Inc ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0781-3233_b1c0f084-78c2-4a1a-a037-034dec8b279d 0781-3233 HUMAN PRESCRIPTION DRUG Cyclophosphamide cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20141031 ANDA ANDA204555 Sandoz Inc. CYCLOPHOSPHAMIDE 500 mg/25mL Alkylating Activity [MoA],Alkylating Drug [EPC] 0781-3239_38ff7b73-d0b1-4cf5-9ff9-9970aea403e8 0781-3239 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION INTRAVENOUS 20080324 ANDA ANDA078252 Sandoz Inc CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0781-3240_38ff7b73-d0b1-4cf5-9ff9-9970aea403e8 0781-3240 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION INTRAVENOUS 20080324 ANDA ANDA078252 Sandoz Inc CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0781-3243_8be94992-efea-4654-ae46-0f0e0b1517fd 0781-3243 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide INJECTION, SUSPENSION INTRA-ARTICULAR; INTRABURSAL; INTRADERMAL; INTRALESIONAL 20090527 ANDA ANDA090166 Sandoz Inc TRIAMCINOLONE ACETONIDE 10 mg/mL 0781-3244_b1c0f084-78c2-4a1a-a037-034dec8b279d 0781-3244 HUMAN PRESCRIPTION DRUG Cyclophosphamide cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20141031 ANDA ANDA204555 Sandoz Inc. CYCLOPHOSPHAMIDE 1 g/50mL Alkylating Activity [MoA],Alkylating Drug [EPC] 0781-3245_14a166c0-4823-4157-8652-829a5e5b4880 0781-3245 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 20090527 ANDA ANDA090164 Sandoz Inc TRIAMCINOLONE ACETONIDE 40 mg/mL 0781-3253_9e1c0729-a23d-4029-9d98-6e0ceea21dba 0781-3253 HUMAN PRESCRIPTION DRUG Azacitidine azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20130916 NDA AUTHORIZED GENERIC NDA050794 Sandoz Inc AZACITIDINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0781-3255_b1c0f084-78c2-4a1a-a037-034dec8b279d 0781-3255 HUMAN PRESCRIPTION DRUG Cyclophosphamide cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20141031 ANDA ANDA204555 Sandoz Inc. CYCLOPHOSPHAMIDE 2 g/100mL Alkylating Activity [MoA],Alkylating Drug [EPC] 0781-3265_50365fe4-70db-487f-8259-42b54e85a2a8 0781-3265 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110329 ANDA ANDA091201 Sandoz Inc MEROPENEM 500 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 0781-3267_50365fe4-70db-487f-8259-42b54e85a2a8 0781-3267 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110329 ANDA ANDA091201 Sandoz Inc MEROPENEM 1 g/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 0781-3285_51da2c58-1153-4089-83c4-068f54bce2f9 0781-3285 HUMAN PRESCRIPTION DRUG Argatroban Argatroban SOLUTION INTRAVENOUS 20110509 NDA NDA022485 Sandoz Inc ARGATROBAN 125 mg/125mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] 0781-3288_775961cf-9f85-4ebb-ad60-326e2a9360a3 0781-3288 HUMAN PRESCRIPTION DRUG Clindamycin in 5 Percent Dextrose Clindamycin in 5 Percent Dextrose INJECTION, SOLUTION INTRAVENOUS 20130207 ANDA ANDA201692 Sandoz Inc CLINDAMYCIN 6 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0781-3289_775961cf-9f85-4ebb-ad60-326e2a9360a3 0781-3289 HUMAN PRESCRIPTION DRUG Clindamycin in 5 Percent Dextrose Clindamycin in 5 Percent Dextrose INJECTION, SOLUTION INTRAVENOUS 20130207 ANDA ANDA201692 Sandoz Inc CLINDAMYCIN 12 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0781-3290_775961cf-9f85-4ebb-ad60-326e2a9360a3 0781-3290 HUMAN PRESCRIPTION DRUG Clindamycin in 5 Percent Dextrose Clindamycin in 5 Percent Dextrose INJECTION, SOLUTION INTRAVENOUS 20130207 ANDA ANDA201692 Sandoz Inc CLINDAMYCIN 18 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0781-3301_072a0aa8-dfb0-4f19-95f8-c8b0a6bceb0c 0781-3301 HUMAN PRESCRIPTION DRUG Cefepime Cefepime Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20101221 ANDA ANDA090291 Sandoz Inc CEFEPIME HYDROCHLORIDE 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-3302_072a0aa8-dfb0-4f19-95f8-c8b0a6bceb0c 0781-3302 HUMAN PRESCRIPTION DRUG Cefepime Cefepime Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20101221 ANDA ANDA090291 Sandoz Inc CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-3303_072a0aa8-dfb0-4f19-95f8-c8b0a6bceb0c 0781-3303 HUMAN PRESCRIPTION DRUG Cefepime Cefepime Hydrochloride INJECTION INTRAVENOUS 20101221 ANDA ANDA090291 Sandoz Inc CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-3305_cd98e82a-caa2-4656-afa9-dad2ca0f76c4 0781-3305 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol INJECTION, SOLUTION INTRAVENOUS 20140204 ANDA ANDA200926 Sandoz Inc DOXERCALCIFEROL 4 ug/2mL Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] 0781-3314_8df568ee-7e5a-4dfc-a346-3b61d917c6b3 0781-3314 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION INTRAVENOUS 20110906 NDA AUTHORIZED GENERIC NDA022434 Sandoz Inc ARGATROBAN 1 mg/mL 0781-3315_ab162009-6f84-4d56-ab56-5e84409ec814 0781-3315 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20120731 ANDA ANDA078817 Sandoz Inc OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0781-3317_ab162009-6f84-4d56-ab56-5e84409ec814 0781-3317 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20120731 ANDA ANDA078817 Sandoz Inc OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0781-3341_62ea669f-fed1-44c1-be83-6c62d1ffb1a7 0781-3341 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20110707 ANDA ANDA090343 Sandoz Inc LEVOFLOXACIN 5 mg/mL 0781-3342_62ea669f-fed1-44c1-be83-6c62d1ffb1a7 0781-3342 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20110707 ANDA ANDA090343 Sandoz Inc LEVOFLOXACIN 5 mg/mL 0781-3343_62ea669f-fed1-44c1-be83-6c62d1ffb1a7 0781-3343 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20110707 ANDA ANDA090343 Sandoz Inc LEVOFLOXACIN 5 mg/mL 0781-3344_822b585b-1db5-42d9-91e3-799693efa647 0781-3344 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110531 ANDA ANDA065523 Sandoz Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0781-3350_822b585b-1db5-42d9-91e3-799693efa647 0781-3350 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110531 ANDA ANDA065523 Sandoz Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0781-3353_5348515d-7e6b-432c-9a98-6ec8103e2cad 0781-3353 HUMAN PRESCRIPTION DRUG DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20141003 NDA AUTHORIZED GENERIC NDA021038 Sandoz Inc. DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] 0781-3356_28b7b493-7bf9-40e4-be7f-3d1d52b64b87 0781-3356 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Sandoz Inc ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0781-3367_822b585b-1db5-42d9-91e3-799693efa647 0781-3367 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110531 ANDA ANDA065523 Sandoz Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0781-3400_2273ffd0-4ac1-4344-a947-04b4e3287278 0781-3400 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 125 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3402_2273ffd0-4ac1-4344-a947-04b4e3287278 0781-3402 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3404_2273ffd0-4ac1-4344-a947-04b4e3287278 0781-3404 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3407_2273ffd0-4ac1-4344-a947-04b4e3287278 0781-3407 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3408_2273ffd0-4ac1-4344-a947-04b4e3287278 0781-3408 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3409_9c2c7248-bc68-4651-aeb1-1f27419bb021 0781-3409 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 10 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3412_2f114dc8-e505-4423-b372-2e3962687178 0781-3412 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19870219 ANDA ANDA062738 Sandoz Inc AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3413_2f114dc8-e505-4423-b372-2e3962687178 0781-3413 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19870219 ANDA ANDA062738 Sandoz Inc AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-3416_0716f52c-66e1-4ce2-acd1-91045fac0a11 0781-3416 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120530 ANDA ANDA090862 Sandoz Inc VORICONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0781-3428_28b7b493-7bf9-40e4-be7f-3d1d52b64b87 0781-3428 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Sandoz Inc ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0781-3440_1342169c-e214-4f22-8363-1fd45b85d1e8 0781-3440 HUMAN PRESCRIPTION DRUG Cosyntropin Cosyntropin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120629 ANDA ANDA202147 Sandoz Inc COSYNTROPIN .25 mg/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] 0781-3450_8933ab98-4a6d-4594-9c8b-31eaa66c96b6 0781-3450 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 19881209 ANDA ANDA062831 Sandoz Inc CEFAZOLIN SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-3451_8933ab98-4a6d-4594-9c8b-31eaa66c96b6 0781-3451 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 19881209 ANDA ANDA062831 Sandoz Inc CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-3452_ebbb83eb-201a-4f8a-94ee-d82d3b99e641 0781-3452 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; PARENTERAL 19881209 ANDA ANDA062831 Sandoz Inc CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-3500_28b7b493-7bf9-40e4-be7f-3d1d52b64b87 0781-3500 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Sandoz Inc ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0781-3612_28b7b493-7bf9-40e4-be7f-3d1d52b64b87 0781-3612 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Sandoz Inc ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0781-3655_28b7b493-7bf9-40e4-be7f-3d1d52b64b87 0781-3655 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Sandoz Inc ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0781-3777_6371588e-b0ee-46d8-a5e0-69636632b8ee 0781-3777 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20030226 ANDA ANDA076400 Sandoz Inc PROPRANOLOL HYDROCHLORIDE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0781-4003_82a87281-0a93-420c-93e1-1e982b57142f 0781-4003 HUMAN PRESCRIPTION DRUG Leuprolide Acetate Leuprolide Acetate KIT 19980804 ANDA ANDA074728 Sandoz Inc 0781-4004_27a5c992-5724-4ed9-a72c-d7d7e1953fc9 0781-4004 HUMAN PRESCRIPTION DRUG Omnitrope Somatropin KIT 20060530 NDA NDA021426 Sandoz Inc 0781-4040_b0406e06-b384-4f8a-9c2c-e8dba2389c42 0781-4040 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine KIT 20100105 ANDA ANDA078645 Sandoz Inc 0781-4054_62f096ec-8684-4c8c-a4c5-eb7c22f559c1 0781-4054 HUMAN PRESCRIPTION DRUG Lansoprazole, Amoxicillin and Clarithromycin Lansoprazole, Amoxicillin and Clarithromycin KIT 20140304 ANDA ANDA202588 Sandoz Inc 0781-4058_926555a2-e3b7-4343-9abf-a94ef433a23b 0781-4058 HUMAN PRESCRIPTION DRUG Estarylla Norgestimate and ethinyl estradiol KIT 20130201 ANDA ANDA090794 Sandoz Inc 0781-4060_5c896e59-de44-491a-919f-930844cbd8af 0781-4060 HUMAN PRESCRIPTION DRUG Tri-Estarylla norgestimate and ethinyl estradiol KIT 20130201 ANDA ANDA090793 Sandoz Inc 0781-5017_68d25747-6634-4b5a-a34f-39bbdd5549e9 0781-5017 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19981120 ANDA ANDA075229 Sandoz Inc DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0781-5020_073eea09-4ffe-41a7-86d8-808b556e389e 0781-5020 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960719 ANDA ANDA040101 Sandoz Inc PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-5021_073eea09-4ffe-41a7-86d8-808b556e389e 0781-5021 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960719 ANDA ANDA040101 Sandoz Inc PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-5022_9744dc0d-5f6f-4388-8ace-dab5d09738f7 0781-5022 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040194 Sandoz Inc METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0781-5043_f38043a1-48b4-4949-9243-a211523d5449 0781-5043 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20051114 ANDA ANDA065235 Sandoz Inc CEFPROZIL 250 mg/1 0781-5044_f38043a1-48b4-4949-9243-a211523d5449 0781-5044 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20051114 ANDA ANDA065235 Sandoz Inc CEFPROZIL 500 mg/1 0781-5050_635644f4-b43d-473a-a87a-d434cdf3bfa7 0781-5050 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Sandoz Inc METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0781-5051_635644f4-b43d-473a-a87a-d434cdf3bfa7 0781-5051 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Sandoz Inc METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0781-5052_635644f4-b43d-473a-a87a-d434cdf3bfa7 0781-5052 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Sandoz Inc METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0781-5056_d552460d-424d-4185-b359-016a4ccf5cd3 0781-5056 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET, FILM COATED ORAL 20050913 ANDA ANDA077087 Sandoz Inc LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] 0781-5057_d552460d-424d-4185-b359-016a4ccf5cd3 0781-5057 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET, FILM COATED ORAL 20050913 ANDA ANDA077087 Sandoz Inc LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] 0781-5060_fa7c7427-a6b2-4b4b-b9b0-3dcafacd375e 0781-5060 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20050713 ANDA ANDA065228 Sandoz Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-5061_fa7c7427-a6b2-4b4b-b9b0-3dcafacd375e 0781-5061 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20050713 ANDA ANDA065228 Sandoz Inc AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-5076_3c36d086-ca46-449c-a653-c376459e83ee 0781-5076 HUMAN PRESCRIPTION DRUG Mefloquine Hydrochloride Mefloquine Hydrochloride TABLET ORAL 20020220 ANDA ANDA076175 Sandoz Inc MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC] 0781-5077_bcf5a8b2-fa3f-469c-821b-cbd0dafd38e4 0781-5077 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030121 ANDA ANDA075209 Sandoz Inc LORATADINE 10 mg/1 0781-5122_b0406e06-b384-4f8a-9c2c-e8dba2389c42 0781-5122 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20100105 ANDA ANDA078645 Sandoz Inc LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0781-5123_b0406e06-b384-4f8a-9c2c-e8dba2389c42 0781-5123 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20100105 ANDA ANDA078645 Sandoz Inc LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0781-5124_b0406e06-b384-4f8a-9c2c-e8dba2389c42 0781-5124 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20100105 ANDA ANDA078645 Sandoz Inc LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0781-5125_b0406e06-b384-4f8a-9c2c-e8dba2389c42 0781-5125 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20100105 ANDA ANDA078645 Sandoz Inc LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0781-5148_2a5d1f34-37aa-49d2-8f28-73acc5589df9 0781-5148 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20131227 ANDA ANDA078555 Sandoz Inc REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0781-5149_2a5d1f34-37aa-49d2-8f28-73acc5589df9 0781-5149 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20140122 ANDA ANDA078555 Sandoz Inc REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0781-5150_2a5d1f34-37aa-49d2-8f28-73acc5589df9 0781-5150 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20140122 ANDA ANDA078555 Sandoz Inc REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 0781-5169_9ae28c68-6b3e-4203-8f8b-fa88a9f2cb48 0781-5169 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20080312 ANDA ANDA077475 Sandoz Inc BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0781-5175_a1c6e09d-f133-45c7-83f1-9d1b06396132 0781-5175 HUMAN PRESCRIPTION DRUG Mycophenolate mofetil Mycophenolate mofetil TABLET ORAL 20081015 ANDA ANDA065451 Sandoz Inc MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 0781-5177_c04e0034-ad1c-4a88-9cc9-d29ece57aeff 0781-5177 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20061003 ANDA ANDA077743 Sandoz Inc RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 0781-5180_c5b56c05-1621-4b69-a7dc-3c5e1e639bd4 0781-5180 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0781-5181_c5b56c05-1621-4b69-a7dc-3c5e1e639bd4 0781-5181 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0781-5182_c5b56c05-1621-4b69-a7dc-3c5e1e639bd4 0781-5182 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0781-5183_c5b56c05-1621-4b69-a7dc-3c5e1e639bd4 0781-5183 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0781-5184_c5b56c05-1621-4b69-a7dc-3c5e1e639bd4 0781-5184 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0781-5185_c5b56c05-1621-4b69-a7dc-3c5e1e639bd4 0781-5185 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0781-5186_c5b56c05-1621-4b69-a7dc-3c5e1e639bd4 0781-5186 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0781-5187_c5b56c05-1621-4b69-a7dc-3c5e1e639bd4 0781-5187 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0781-5188_c5b56c05-1621-4b69-a7dc-3c5e1e639bd4 0781-5188 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0781-5189_c5b56c05-1621-4b69-a7dc-3c5e1e639bd4 0781-5189 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0781-5190_c5b56c05-1621-4b69-a7dc-3c5e1e639bd4 0781-5190 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 300 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0781-5191_c5b56c05-1621-4b69-a7dc-3c5e1e639bd4 0781-5191 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 0781-5204_faed0638-902c-4d90-a359-1d7a88077c23 0781-5204 HUMAN PRESCRIPTION DRUG Losartan potassium and hydrochlorothiazide Losartan potassium and hydrochlorothiazide tablets TABLET, FILM COATED ORAL 20101006 ANDA ANDA077948 Sandoz Inc HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-5206_faed0638-902c-4d90-a359-1d7a88077c23 0781-5206 HUMAN PRESCRIPTION DRUG Losartan potassium and hydrochlorothiazide Losartan potassium and hydrochlorothiazide tablets TABLET, FILM COATED ORAL 20101006 ANDA ANDA077948 Sandoz Inc HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-5207_faed0638-902c-4d90-a359-1d7a88077c23 0781-5207 HUMAN PRESCRIPTION DRUG Losartan potassium and hydrochlorothiazide Losartan potassium and hydrochlorothiazide tablets TABLET, FILM COATED ORAL 20101006 ANDA ANDA077948 Sandoz Inc HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-5208_06ce1f4b-35ee-450f-bca3-b62f3bb66f04 0781-5208 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET ORAL 20100524 ANDA ANDA077478 Sandoz Inc VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0781-5209_06ce1f4b-35ee-450f-bca3-b62f3bb66f04 0781-5209 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET ORAL 20100524 ANDA ANDA077478 Sandoz Inc VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0781-5220_a89b06fa-6d67-4563-b42e-dfef72e534a4 0781-5220 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 ANDA ANDA074052 Sandoz Inc ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0781-5221_bc54e471-cc75-4c13-9b30-9dd5d2b79505 0781-5221 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 Sandoz Inc CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0781-5222_bc54e471-cc75-4c13-9b30-9dd5d2b79505 0781-5222 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 Sandoz Inc CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0781-5223_bc54e471-cc75-4c13-9b30-9dd5d2b79505 0781-5223 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 Sandoz Inc CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0781-5224_bc54e471-cc75-4c13-9b30-9dd5d2b79505 0781-5224 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070906 ANDA ANDA078227 Sandoz Inc CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0781-5225_a89b06fa-6d67-4563-b42e-dfef72e534a4 0781-5225 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073025 Sandoz Inc ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0781-5226_71b60805-c4ec-462f-874d-3e289243966c 0781-5226 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET ORAL 20130701 ANDA ANDA078364 Sandoz Inc DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0781-5229_a89b06fa-6d67-4563-b42e-dfef72e534a4 0781-5229 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073026 Sandoz Inc ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0781-5231_192fd8e8-7b77-4762-9304-005f5681e129 0781-5231 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20140428 ANDA ANDA076397 Sandoz Inc PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0781-5232_192fd8e8-7b77-4762-9304-005f5681e129 0781-5232 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20140428 ANDA ANDA076397 Sandoz Inc PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0781-5234_192fd8e8-7b77-4762-9304-005f5681e129 0781-5234 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20140428 ANDA ANDA076397 Sandoz Inc PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0781-5235_d47b7e25-1dd3-41dc-886d-98f6efc0c0ba 0781-5235 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20140728 ANDA ANDA077491 Sandoz Inc PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0781-5238_4fd1dfe4-b649-456f-b196-90f77619cc75 0781-5238 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA078050 Sandoz Inc ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0781-5239_4fd1dfe4-b649-456f-b196-90f77619cc75 0781-5239 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070813 ANDA ANDA078050 Sandoz Inc ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0781-5248_196665b8-c5c1-4655-8442-eee41bb3ec56 0781-5248 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100706 ANDA ANDA090190 Sandoz Inc PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0781-5249_196665b8-c5c1-4655-8442-eee41bb3ec56 0781-5249 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100706 ANDA ANDA090190 Sandoz Inc PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0781-5250_196665b8-c5c1-4655-8442-eee41bb3ec56 0781-5250 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100706 ANDA ANDA090190 Sandoz Inc PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0781-5251_196665b8-c5c1-4655-8442-eee41bb3ec56 0781-5251 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100706 ANDA ANDA090190 Sandoz Inc PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0781-5252_196665b8-c5c1-4655-8442-eee41bb3ec56 0781-5252 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100706 ANDA ANDA090190 Sandoz Inc PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0781-5274_a2416636-d799-4ff1-9aa6-00190fd5a276 0781-5274 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET ORAL 20110531 ANDA ANDA090290 Sandoz Inc DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0781-5275_a2416636-d799-4ff1-9aa6-00190fd5a276 0781-5275 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET ORAL 20110531 ANDA ANDA090290 Sandoz Inc DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0781-5276_29ccd679-4679-40aa-b952-d64e5a1c462a 0781-5276 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20110510 ANDA ANDA091198 Sandoz Inc DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0781-5277_29ccd679-4679-40aa-b952-d64e5a1c462a 0781-5277 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20110510 ANDA ANDA091198 Sandoz Inc DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0781-5281_196665b8-c5c1-4655-8442-eee41bb3ec56 0781-5281 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090190 Sandoz Inc PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0781-5283_8f721b0d-4ed3-4c25-9666-250d890e665b 0781-5283 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20080214 ANDA ANDA078692 Sandoz Inc CETIRIZINE HYDROCHLORIDE 5 mg/1 0781-5284_5a63af45-f72c-406d-a061-a0b56ca4bffc 0781-5284 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20080214 ANDA ANDA078692 Sandoz Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 0781-5310_e3b6a41e-018f-49e6-9559-5cf386defcf4 0781-5310 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091222 ANDA ANDA078116 Sandoz Inc RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 0781-5311_e3b6a41e-018f-49e6-9559-5cf386defcf4 0781-5311 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091222 ANDA ANDA078116 Sandoz Inc RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 0781-5312_e3b6a41e-018f-49e6-9559-5cf386defcf4 0781-5312 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091222 ANDA ANDA078116 Sandoz Inc RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 0781-5313_e3b6a41e-018f-49e6-9559-5cf386defcf4 0781-5313 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091222 ANDA ANDA078116 Sandoz Inc RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 0781-5314_e3b6a41e-018f-49e6-9559-5cf386defcf4 0781-5314 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091222 ANDA ANDA078116 Sandoz Inc RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 0781-5315_d1f3c3d7-a8a3-455e-be9b-aff251fa931a 0781-5315 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090107 Sandoz Inc ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0781-5316_d1f3c3d7-a8a3-455e-be9b-aff251fa931a 0781-5316 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090107 Sandoz Inc ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0781-5317_2963ec25-a1f1-403a-a539-bce7b19d46d0 0781-5317 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, COATED ORAL 20070423 ANDA ANDA077322 Sandoz Inc ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0781-5318_2963ec25-a1f1-403a-a539-bce7b19d46d0 0781-5318 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, COATED ORAL 20070423 ANDA ANDA077322 Sandoz Inc ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0781-5325_a9bd5400-2654-43ff-ba86-e372dd924a63 0781-5325 HUMAN PRESCRIPTION DRUG Bromocriptine mesylate Bromocriptine mesylate TABLET ORAL 19980113 ANDA ANDA074631 Sandoz Inc BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 0781-5342_d897ab87-745c-4138-a6cc-d031885b230e 0781-5342 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 Sandoz Inc QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 0781-5343_d897ab87-745c-4138-a6cc-d031885b230e 0781-5343 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 Sandoz Inc QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 0781-5344_d897ab87-745c-4138-a6cc-d031885b230e 0781-5344 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 Sandoz Inc QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 0781-5345_d897ab87-745c-4138-a6cc-d031885b230e 0781-5345 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 Sandoz Inc QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] 0781-5346_d897ab87-745c-4138-a6cc-d031885b230e 0781-5346 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 Sandoz Inc QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 0781-5347_d897ab87-745c-4138-a6cc-d031885b230e 0781-5347 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 Sandoz Inc QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 0781-5348_d897ab87-745c-4138-a6cc-d031885b230e 0781-5348 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 Sandoz Inc QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 0781-5356_b97c8f13-43ad-4130-b6ec-e945cb77d55d 0781-5356 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, FILM COATED ORAL 20100628 ANDA ANDA079007 Sandoz Inc ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 0781-5371_1e9f779d-5859-4b11-9b7a-d3efcbe83693 0781-5371 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070103 ANDA ANDA071403 Sandoz Inc LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0781-5372_6ebdf669-2edc-46ff-a6cc-e1c4075590ef 0781-5372 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20141208 ANDA ANDA203867 Sandoz Inc TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5374_6ebdf669-2edc-46ff-a6cc-e1c4075590ef 0781-5374 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20141208 ANDA ANDA203867 Sandoz Inc TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5377_1e9f779d-5859-4b11-9b7a-d3efcbe83693 0781-5377 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 Sandoz Inc LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0781-5378_6ebdf669-2edc-46ff-a6cc-e1c4075590ef 0781-5378 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20141208 ANDA ANDA203867 Sandoz Inc TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5379_1e9f779d-5859-4b11-9b7a-d3efcbe83693 0781-5379 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070108 ANDA ANDA071141 Sandoz Inc LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0781-5381_01e7495f-43e1-4a90-b75e-5e6e88a67ee8 0781-5381 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20120529 ANDA ANDA077575 Sandoz Inc ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0781-5382_01e7495f-43e1-4a90-b75e-5e6e88a67ee8 0781-5382 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20120529 ANDA ANDA077575 Sandoz Inc ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0781-5384_01e7495f-43e1-4a90-b75e-5e6e88a67ee8 0781-5384 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20120529 ANDA ANDA077575 Sandoz Inc ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0781-5385_8cf1d3df-fdb9-4f13-aa38-7a4238d152b5 0781-5385 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090813 ANDA ANDA090422 Sandoz Inc MINOCYCLINE HYDROCHLORIDE 45 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0781-5386_8cf1d3df-fdb9-4f13-aa38-7a4238d152b5 0781-5386 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090813 ANDA ANDA090422 Sandoz Inc MINOCYCLINE HYDROCHLORIDE 90 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0781-5387_8cf1d3df-fdb9-4f13-aa38-7a4238d152b5 0781-5387 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090813 ANDA ANDA090422 Sandoz Inc MINOCYCLINE HYDROCHLORIDE 135 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 0781-5388_01e7495f-43e1-4a90-b75e-5e6e88a67ee8 0781-5388 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20120529 ANDA ANDA077575 Sandoz Inc ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0781-5404_4dd897c7-5492-4d21-be33-2a930821fa17 0781-5404 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070103 ANDA ANDA071403 Sandoz Inc LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0781-5405_b4a06de6-f837-43a8-ae7a-aadb38dd2a7d 0781-5405 HUMAN PRESCRIPTION DRUG Cafergot Ergotamine Tartrate and Caffeine TABLET, FILM COATED ORAL 19820101 ANDA ANDA084294 Sandoz Inc CAFFEINE; ERGOTAMINE TARTRATE 100; 1 mg/1; mg/1 Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0781-5406_4dd897c7-5492-4d21-be33-2a930821fa17 0781-5406 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 Sandoz Inc LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0781-5408_4dd897c7-5492-4d21-be33-2a930821fa17 0781-5408 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070108 ANDA ANDA071141 Sandoz Inc LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0781-5409_19c9e03f-bdac-4ca0-ad47-1b255610d99f 0781-5409 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET ORAL 20090706 ANDA ANDA078575 Sandoz Inc BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 0781-5420_3c41c6c7-f1f3-40cb-87dc-d98716a7f858 0781-5420 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20130301 ANDA ANDA078670 Sandoz Inc PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0781-5421_3c41c6c7-f1f3-40cb-87dc-d98716a7f858 0781-5421 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20130301 ANDA ANDA078670 Sandoz Inc PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0781-5422_3c41c6c7-f1f3-40cb-87dc-d98716a7f858 0781-5422 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20130301 ANDA ANDA078670 Sandoz Inc PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 0781-5425_f1d08f03-3125-48cb-ac9c-05a36111f9a5 0781-5425 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130702 ANDA ANDA078739 Sandoz Inc RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0781-5426_f1d08f03-3125-48cb-ac9c-05a36111f9a5 0781-5426 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130702 ANDA ANDA078739 Sandoz Inc RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0781-5438_fa487191-4b42-4a56-97f6-4a7cafdc6e93 0781-5438 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil TABLET, FILM COATED ORAL 20080528 ANDA ANDA065462 Sandoz Inc CEFPODOXIME PROXETIL 100 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-5439_fa487191-4b42-4a56-97f6-4a7cafdc6e93 0781-5439 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil TABLET, FILM COATED ORAL 20080528 ANDA ANDA065462 Sandoz Inc CEFPODOXIME PROXETIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-5485_2978b28c-91e1-4b17-9670-7b03717c1711 0781-5485 HUMAN PRESCRIPTION DRUG Rizatriptan benzoate Rizatriptan benzoate TABLET ORAL 20130211 ANDA ANDA079230 Sandoz Inc RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0781-5486_2978b28c-91e1-4b17-9670-7b03717c1711 0781-5486 HUMAN PRESCRIPTION DRUG Rizatriptan benzoate Rizatriptan benzoate TABLET ORAL 20130211 ANDA ANDA079230 Sandoz Inc RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0781-5514_98829d90-b289-4bec-a625-7af412a5cb2d 0781-5514 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin TABLET ORAL 20130807 ANDA ANDA091592 Sandoz Inc GRISEOFULVIN 250 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 0781-5515_98829d90-b289-4bec-a625-7af412a5cb2d 0781-5515 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin TABLET ORAL 20130807 ANDA ANDA091592 Sandoz Inc GRISEOFULVIN 500 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 0781-5526_d30bf5ef-b3f2-4263-9a44-b276ad42296e 0781-5526 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET, COATED ORAL 20100707 ANDA ANDA090288 Sandoz Inc NARATRIPTAN HYDROCHLORIDE 1 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0781-5527_d30bf5ef-b3f2-4263-9a44-b276ad42296e 0781-5527 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET, COATED ORAL 20100707 ANDA ANDA090288 Sandoz Inc NARATRIPTAN HYDROCHLORIDE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0781-5554_bf9b8235-944e-49e4-b722-caa1996c14e1 0781-5554 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET, CHEWABLE ORAL 20120803 ANDA ANDA091414 Sandoz Inc MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0781-5555_bf9b8235-944e-49e4-b722-caa1996c14e1 0781-5555 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET, CHEWABLE ORAL 20120803 ANDA ANDA091414 Sandoz Inc MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0781-5560_bf9b8235-944e-49e4-b722-caa1996c14e1 0781-5560 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET, FILM COATED ORAL 20120803 ANDA ANDA200889 Sandoz Inc MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0781-5578_ad4b6d79-efd3-4c43-b4dc-5afdacf939a4 0781-5578 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20140604 NDA AUTHORIZED GENERIC NDA020796 Sandoz Inc ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0781-5583_4d45e6d1-8814-4a54-a5c2-cea4fe368c6c 0781-5583 HUMAN PRESCRIPTION DRUG ALTAVERA Levonorgestrel and Ethinyl Estradiol KIT 20100803 ANDA ANDA079102 Sandoz Inc 0781-5584_880d360a-7b1f-4b74-b61c-af13310cb6f4 0781-5584 HUMAN PRESCRIPTION DRUG Introvale Levonorgestrel and Ethinyl Estradiol KIT 20100927 ANDA ANDA079064 Sandoz Inc 0781-5607_442afae9-22f0-42f6-b108-c5b711f84eb2 0781-5607 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20140707 NDA AUTHORIZED GENERIC NDA021283 Sandoz Inc VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5608_442afae9-22f0-42f6-b108-c5b711f84eb2 0781-5608 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20140707 NDA AUTHORIZED GENERIC NDA021283 Sandoz Inc VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5613_9c16c0e0-3b97-486b-b7d5-579f5853e2c5 0781-5613 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa, and Entacapone Carbidopa, Levodopa, and Entacapone TABLET, FILM COATED ORAL 20140618 NDA AUTHORIZED GENERIC NDA021485 Sandoz Inc CARBIDOPA; ENTACAPONE; LEVODOPA 12.5; 200; 50 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0781-5618_442afae9-22f0-42f6-b108-c5b711f84eb2 0781-5618 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20140707 NDA AUTHORIZED GENERIC NDA021283 Sandoz Inc VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5619_442afae9-22f0-42f6-b108-c5b711f84eb2 0781-5619 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20140707 NDA AUTHORIZED GENERIC NDA021283 Sandoz Inc VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5621_0013aad0-f2c5-40e8-9f9e-85cb13a97674 0781-5621 HUMAN PRESCRIPTION DRUG Famciclovir famciclovir TABLET, FILM COATED ORAL 20110307 20150131 NDA AUTHORIZED GENERIC NDA020363 Sandoz Inc FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0781-5625_9c16c0e0-3b97-486b-b7d5-579f5853e2c5 0781-5625 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa, and Entacapone Carbidopa, Levodopa, and Entacapone TABLET, FILM COATED ORAL 20140618 NDA AUTHORIZED GENERIC NDA021485 Sandoz Inc CARBIDOPA; ENTACAPONE; LEVODOPA 18.75; 200; 75 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0781-5626_ad58517f-5400-4839-9ce7-3ddbe2480647 0781-5626 HUMAN PRESCRIPTION DRUG Pioglitazone and metformin Pioglitazone and metformin TABLET, FILM COATED ORAL 20130502 ANDA ANDA091273 Sandoz Inc METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0781-5627_ad58517f-5400-4839-9ce7-3ddbe2480647 0781-5627 HUMAN PRESCRIPTION DRUG Pioglitazone and metformin Pioglitazone and metformin TABLET, FILM COATED ORAL 20130502 ANDA ANDA091273 Sandoz Inc METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 0781-5634_8f226aa4-5b17-4832-81d8-d24ba08dfcd6 0781-5634 HUMAN PRESCRIPTION DRUG Pioglitazone hydrochloride and glimepiride Pioglitazone hydrochloride and glimepiride TABLET ORAL 20130108 ANDA ANDA201049 Sandoz Inc GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE 2; 30 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0781-5635_8f226aa4-5b17-4832-81d8-d24ba08dfcd6 0781-5635 HUMAN PRESCRIPTION DRUG Pioglitazone hydrochloride and glimepiride Pioglitazone hydrochloride and glimepiride TABLET ORAL 20130108 ANDA ANDA201049 Sandoz Inc GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE 4; 30 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0781-5637_9c16c0e0-3b97-486b-b7d5-579f5853e2c5 0781-5637 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa, and Entacapone Carbidopa, Levodopa, and Entacapone TABLET, FILM COATED ORAL 20140618 NDA AUTHORIZED GENERIC NDA021485 Sandoz Inc CARBIDOPA; ENTACAPONE; LEVODOPA 25; 200; 100 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0781-5641_9c16c0e0-3b97-486b-b7d5-579f5853e2c5 0781-5641 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa, and Entacapone Carbidopa, Levodopa, and Entacapone TABLET, FILM COATED ORAL 20140618 NDA AUTHORIZED GENERIC NDA021485 Sandoz Inc CARBIDOPA; ENTACAPONE; LEVODOPA 31.25; 200; 125 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0781-5654_9c16c0e0-3b97-486b-b7d5-579f5853e2c5 0781-5654 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa, and Entacapone Carbidopa, Levodopa, and Entacapone TABLET, FILM COATED ORAL 20140618 NDA AUTHORIZED GENERIC NDA021485 Sandoz Inc CARBIDOPA; ENTACAPONE; LEVODOPA 37.5; 200; 150 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0781-5656_84121216-cebc-4c62-85b4-0c724819c8c5 0781-5656 HUMAN PRESCRIPTION DRUG Loryna drospirenone and ethinyl estradiol KIT 20110328 ANDA ANDA079221 Sandoz Inc 0781-5658_e564a349-c386-4ef8-98f6-652ca5c8250e 0781-5658 HUMAN PRESCRIPTION DRUG Syeda Drospirenone and Ethinyl Estradiol KIT 20110328 ANDA ANDA090114 Sandoz Inc 0781-5667_8e9af73e-3e7c-403d-a50c-25aa9c1bac1f 0781-5667 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20111212 ANDA ANDA200265 Sandoz Inc VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0781-5668_8e9af73e-3e7c-403d-a50c-25aa9c1bac1f 0781-5668 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20111212 ANDA ANDA200265 Sandoz Inc VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 0781-5669_9c16c0e0-3b97-486b-b7d5-579f5853e2c5 0781-5669 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa, and Entacapone Carbidopa, Levodopa, and Entacapone TABLET, FILM COATED ORAL 20140618 NDA AUTHORIZED GENERIC NDA021485 Sandoz Inc CARBIDOPA; ENTACAPONE; LEVODOPA 50; 200; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 0781-5700_0d972052-2917-457c-98e1-0aaa55ec070e 0781-5700 HUMAN PRESCRIPTION DRUG losartan potassium losartan potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA077424 Sandoz Inc LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5701_0d972052-2917-457c-98e1-0aaa55ec070e 0781-5701 HUMAN PRESCRIPTION DRUG losartan potassium losartan potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA077424 Sandoz Inc LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5702_0d972052-2917-457c-98e1-0aaa55ec070e 0781-5702 HUMAN PRESCRIPTION DRUG losartan potassium losartan potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA077424 Sandoz Inc LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5703_2daac07a-7b11-4e90-bc56-20a4f54fbbf8 0781-5703 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141008 NDA AUTHORIZED GENERIC NDA022272 Sandoz Inc OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0781-5710_a175b2a1-3c08-4873-b982-926166494867 0781-5710 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19981120 ANDA ANDA074726 Sandoz Inc POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0781-5720_a175b2a1-3c08-4873-b982-926166494867 0781-5720 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19981120 ANDA ANDA074726 Sandoz Inc POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0781-5726_2daac07a-7b11-4e90-bc56-20a4f54fbbf8 0781-5726 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141008 NDA AUTHORIZED GENERIC NDA022272 Sandoz Inc OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0781-5748_880fd193-8fdc-4ba8-9491-0033cb2b7442 0781-5748 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 19551231 NDA AUTHORIZED GENERIC NDA010187 Sandoz Inc METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0781-5749_880fd193-8fdc-4ba8-9491-0033cb2b7442 0781-5749 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 19551231 NDA AUTHORIZED GENERIC NDA010187 Sandoz Inc METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0781-5753_880fd193-8fdc-4ba8-9491-0033cb2b7442 0781-5753 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 19551231 NDA AUTHORIZED GENERIC NDA010187 Sandoz Inc METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0781-5754_880fd193-8fdc-4ba8-9491-0033cb2b7442 0781-5754 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride SR methylphenidate hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19820331 NDA AUTHORIZED GENERIC NDA018029 Sandoz Inc METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 0781-5756_dd311bf0-c5c8-4f0b-9f8f-e855bb32a71e 0781-5756 HUMAN PRESCRIPTION DRUG AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 NDA AUTHORIZED GENERIC NDA022314 Sandoz Inc AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5; 12.5; 160 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-5760_dd311bf0-c5c8-4f0b-9f8f-e855bb32a71e 0781-5760 HUMAN PRESCRIPTION DRUG AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 NDA AUTHORIZED GENERIC NDA022314 Sandoz Inc AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10; 12.5; 160 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-5767_2daac07a-7b11-4e90-bc56-20a4f54fbbf8 0781-5767 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141008 NDA AUTHORIZED GENERIC NDA022272 Sandoz Inc OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0781-5771_dd311bf0-c5c8-4f0b-9f8f-e855bb32a71e 0781-5771 HUMAN PRESCRIPTION DRUG AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 NDA AUTHORIZED GENERIC NDA022314 Sandoz Inc AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5; 25; 160 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-5780_d24dc686-3bb8-4b89-996c-3dbdc3f5f3d1 0781-5780 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA201047 Sandoz Inc ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0781-5782_d24dc686-3bb8-4b89-996c-3dbdc3f5f3d1 0781-5782 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA201047 Sandoz Inc ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0781-5784_d24dc686-3bb8-4b89-996c-3dbdc3f5f3d1 0781-5784 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA201047 Sandoz Inc ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0781-5785_2daac07a-7b11-4e90-bc56-20a4f54fbbf8 0781-5785 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141008 NDA AUTHORIZED GENERIC NDA022272 Sandoz Inc OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0781-5786_d24dc686-3bb8-4b89-996c-3dbdc3f5f3d1 0781-5786 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA201047 Sandoz Inc ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0781-5787_dd311bf0-c5c8-4f0b-9f8f-e855bb32a71e 0781-5787 HUMAN PRESCRIPTION DRUG AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 NDA AUTHORIZED GENERIC NDA022314 Sandoz Inc AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10; 25; 160 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-5788_d24dc686-3bb8-4b89-996c-3dbdc3f5f3d1 0781-5788 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA201047 Sandoz Inc ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0781-5790_afe24f34-b595-46c7-9e1e-2c4dc10086ed 0781-5790 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Sandoz Inc LEVOFLOXACIN 250 mg/1 0781-5791_afe24f34-b595-46c7-9e1e-2c4dc10086ed 0781-5791 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Sandoz Inc LEVOFLOXACIN 500 mg/1 0781-5792_afe24f34-b595-46c7-9e1e-2c4dc10086ed 0781-5792 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Sandoz Inc LEVOFLOXACIN 750 mg/1 0781-5794_dd311bf0-c5c8-4f0b-9f8f-e855bb32a71e 0781-5794 HUMAN PRESCRIPTION DRUG AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 NDA AUTHORIZED GENERIC NDA022314 Sandoz Inc AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10; 25; 320 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-5805_ea4a85dd-1f98-48ee-98fe-1f4a09340cbd 0781-5805 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Sandoz Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5806_ea4a85dd-1f98-48ee-98fe-1f4a09340cbd 0781-5806 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Sandoz Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5807_ea4a85dd-1f98-48ee-98fe-1f4a09340cbd 0781-5807 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Sandoz Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5816_83c4f278-a699-41b6-b372-63072cdbc202 0781-5816 HUMAN PRESCRIPTION DRUG losartan potassium and hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Sandoz Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-5817_83c4f278-a699-41b6-b372-63072cdbc202 0781-5817 HUMAN PRESCRIPTION DRUG losartan potassium and hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Sandoz Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-5818_83c4f278-a699-41b6-b372-63072cdbc202 0781-5818 HUMAN PRESCRIPTION DRUG losartan potassium and hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Sandoz Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-5893_1cdfddd4-25f2-484d-958e-2c6d6b825f98 0781-5893 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET, EXTENDED RELEASE ORAL 20140415 ANDA ANDA203411 Sandoz Inc NEVIRAPINE 400 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 0781-5913_ffbd7a62-f6fa-4add-a039-5369b9928ae4 0781-5913 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA083386 Sandoz Inc CHLORPROMAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-5914_ffbd7a62-f6fa-4add-a039-5369b9928ae4 0781-5914 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084112 Sandoz Inc CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-5915_ffbd7a62-f6fa-4add-a039-5369b9928ae4 0781-5915 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084113 Sandoz Inc CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-5916_ffbd7a62-f6fa-4add-a039-5369b9928ae4 0781-5916 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084114 Sandoz Inc CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-5917_ffbd7a62-f6fa-4add-a039-5369b9928ae4 0781-5917 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084115 Sandoz Inc CHLORPROMAZINE HYDROCHLORIDE 200 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0781-5936_d98f02ab-1f3f-40ad-b301-5b5e1f58c140 0781-5936 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 ANDA ANDA078702 Sandoz Inc CANDESARTAN CILEXETIL 4 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5937_d98f02ab-1f3f-40ad-b301-5b5e1f58c140 0781-5937 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 ANDA ANDA078702 Sandoz Inc CANDESARTAN CILEXETIL 8 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5938_d98f02ab-1f3f-40ad-b301-5b5e1f58c140 0781-5938 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 ANDA ANDA078702 Sandoz Inc CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5939_d98f02ab-1f3f-40ad-b301-5b5e1f58c140 0781-5939 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 ANDA ANDA078702 Sandoz Inc CANDESARTAN CILEXETIL 32 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0781-5948_ff7a21b8-e6b1-4111-a48f-143877db39eb 0781-5948 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 NDA AUTHORIZED GENERIC NDA020818 Sandoz Inc HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-5949_ff7a21b8-e6b1-4111-a48f-143877db39eb 0781-5949 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 NDA AUTHORIZED GENERIC NDA020818 Sandoz Inc HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-5950_ff7a21b8-e6b1-4111-a48f-143877db39eb 0781-5950 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 NDA AUTHORIZED GENERIC NDA020818 Sandoz Inc HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-5951_ff7a21b8-e6b1-4111-a48f-143877db39eb 0781-5951 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 NDA AUTHORIZED GENERIC NDA020818 Sandoz Inc HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-5952_ff7a21b8-e6b1-4111-a48f-143877db39eb 0781-5952 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 NDA AUTHORIZED GENERIC NDA020818 Sandoz Inc HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0781-5986_cc5c3255-e6a7-4d01-8817-e0b32f4c41ce 0781-5986 HUMAN PRESCRIPTION DRUG Carbamazepine ER Carbamazepine TABLET, EXTENDED RELEASE ORAL 19960325 NDA AUTHORIZED GENERIC NDA020234 Sandoz Inc CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0781-5987_cc5c3255-e6a7-4d01-8817-e0b32f4c41ce 0781-5987 HUMAN PRESCRIPTION DRUG Carbamazepine ER Carbamazepine TABLET, EXTENDED RELEASE ORAL 19960325 NDA AUTHORIZED GENERIC NDA020234 Sandoz Inc CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0781-5988_cc5c3255-e6a7-4d01-8817-e0b32f4c41ce 0781-5988 HUMAN PRESCRIPTION DRUG Carbamazepine ER Carbamazepine TABLET, EXTENDED RELEASE ORAL 19960325 NDA AUTHORIZED GENERIC NDA020234 Sandoz Inc CARBAMAZEPINE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0781-6022_d6e10fb3-34ea-40b3-81d7-e9db9795face 0781-6022 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin FOR SUSPENSION ORAL 20070904 ANDA ANDA065283 Sandoz Inc CLARITHROMYCIN 125 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0781-6023_d6e10fb3-34ea-40b3-81d7-e9db9795face 0781-6023 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin FOR SUSPENSION ORAL 20070904 ANDA ANDA065283 Sandoz Inc CLARITHROMYCIN 250 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0781-6039_fa7c7427-a6b2-4b4b-b9b0-3dcafacd375e 0781-6039 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20070326 ANDA ANDA065387 Sandoz Inc AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-6041_fa7c7427-a6b2-4b4b-b9b0-3dcafacd375e 0781-6041 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20070326 ANDA ANDA065387 Sandoz Inc AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-6077_e51c7f46-2e71-4f85-b9e6-9be527f6d106 0781-6077 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070406 ANDA ANDA065337 Sandoz Inc CEFDINIR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-6078_e51c7f46-2e71-4f85-b9e6-9be527f6d106 0781-6078 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070406 ANDA ANDA065337 Sandoz Inc CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-6087_c08234ca-78f9-4e97-a4d4-0fbc4fd45bd1 0781-6087 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SYRUP TOPICAL 20111025 20201025 ANDA ANDA090054 Sandoz Inc. RANITIDINE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0781-6102_e01b98fd-1667-47a4-ac2e-4c1ff48e1b4c 0781-6102 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20020605 ANDA ANDA065066 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0781-6104_e01b98fd-1667-47a4-ac2e-4c1ff48e1b4c 0781-6104 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20020605 ANDA ANDA065066 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0781-6135_3c0c0a9c-c6ad-4083-8cb1-459116c9e7f6 0781-6135 HUMAN PRESCRIPTION DRUG Penicillin G Potassium Penicillin G Potassium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010830 ANDA ANDA065079 Sandoz Inc PENICILLIN G POTASSIUM 5000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-6136_3c0c0a9c-c6ad-4083-8cb1-459116c9e7f6 0781-6136 HUMAN PRESCRIPTION DRUG Penicillin G Potassium Penicillin G Potassium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010830 ANDA ANDA065079 Sandoz Inc PENICILLIN G POTASSIUM 20000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-6139_e06238bc-02f2-4adb-9e88-6d73dcc337dc 0781-6139 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium SUSPENSION ORAL 20070813 ANDA ANDA065358 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 0781-6141_947fbbb4-b939-4a5a-93b4-5569ad3451c8 0781-6141 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090115 ANDA ANDA079107 Sandoz Inc. LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0781-6153_5eb23c35-8871-43b6-8d5f-6e3239a665a7 0781-6153 HUMAN PRESCRIPTION DRUG Penicillin G Sodium Penicillin G Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010226 ANDA ANDA065068 Sandoz Inc PENICILLIN G SODIUM 5000000 [USP&apos'U]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-6156_fa7c7427-a6b2-4b4b-b9b0-3dcafacd375e 0781-6156 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20070326 ANDA ANDA065378 Sandoz Inc AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-6157_fa7c7427-a6b2-4b4b-b9b0-3dcafacd375e 0781-6157 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20070326 ANDA ANDA065378 Sandoz Inc AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-6168_75ef1f0b-f03b-49e3-aeaf-209e8848ddd3 0781-6168 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil GRANULE, FOR SUSPENSION ORAL 20090625 ANDA ANDA090031 Sandoz Inc CEFPODOXIME PROXETIL 50 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-6169_75ef1f0b-f03b-49e3-aeaf-209e8848ddd3 0781-6169 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil GRANULE, FOR SUSPENSION ORAL 20090625 ANDA ANDA090031 Sandoz Inc CEFPODOXIME PROXETIL 100 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-6202_f38043a1-48b4-4949-9243-a211523d5449 0781-6202 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20051205 ANDA ANDA065257 Sandoz Inc CEFPROZIL 125 mg/5mL 0781-6203_f38043a1-48b4-4949-9243-a211523d5449 0781-6203 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20051205 ANDA ANDA065257 Sandoz Inc CEFPROZIL 250 mg/5mL 0781-6320_99e9e62b-9796-42ec-8f69-551dabf92ec1 0781-6320 HUMAN PRESCRIPTION DRUG calcitonin salmon calcitonin salmon SPRAY, METERED NASAL 19950801 NDA AUTHORIZED GENERIC NDA020313 Sandoz Inc CALCITONIN SALMON 200 [iU]/1 Calcitonin [Chemical/Ingredient],Calcitonin [EPC] 0781-6523_fc985f8d-8f4c-441f-a3c2-177c6fb4a8d0 0781-6523 HUMAN PRESCRIPTION DRUG SUMATRIPTAN sumatriptan SPRAY NASAL 20080911 NDA NDA020626 Sandoz Inc SUMATRIPTAN 20 mg/100uL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0781-6524_fc985f8d-8f4c-441f-a3c2-177c6fb4a8d0 0781-6524 HUMAN PRESCRIPTION DRUG SUMATRIPTAN sumatriptan SPRAY NASAL 20080911 NDA NDA020626 Sandoz Inc SUMATRIPTAN 5 mg/100uL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 0781-7054_318764a6-527a-4902-b9d6-2a7ed1a1b5ca 0781-7054 HUMAN PRESCRIPTION DRUG Erythromycin and Benzoyl Peroxide Erythromycin and Benzoyl Peroxide KIT TOPICAL 20040329 ANDA ANDA065112 Sandoz 0781-7074_fb5cfb06-cf8c-4f39-9f1e-a532f0f37512 0781-7074 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20040123 ANDA ANDA076603 Sandoz Inc BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0781-7077_5d5728bc-0a01-4bbd-886b-b5729e6b1898 0781-7077 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL VAGINAL 20061031 ANDA ANDA077264 Sandoz Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0781-7078_3e9970ae-ecb9-4a4f-83f1-f1d6a7b39b91 0781-7078 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL TOPICAL 20060713 ANDA ANDA077547 Sandoz Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0781-7080_efb30dd0-e2de-4a31-af82-7a0484d137b4 0781-7080 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL TOPICAL 20130701 ANDA ANDA090903 Sandoz Inc. METRONIDAZOLE 10 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0781-7090_d2cac47a-9e6a-4b30-8eb8-f8ccc3cf718d 0781-7090 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole SHAMPOO, SUSPENSION TOPICAL 20051104 ANDA ANDA076942 Sandoz Inc. KETOCONAZOLE 20.5 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 0781-7094_318764a6-527a-4902-b9d6-2a7ed1a1b5ca 0781-7094 HUMAN PRESCRIPTION DRUG Erythromycin and Benzoyl Peroxide Erythromycin and Benzoyl Peroxide KIT TOPICAL 20040329 ANDA ANDA065112 Sandoz 0781-7106_428ae8ac-780b-4fe0-8d06-0dc4b1359d2a 0781-7106 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SOLUTION TOPICAL 20070918 ANDA ANDA077687 Sandoz CICLOPIROX 80 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 0781-7117_67aae09e-dfb8-4238-9078-db586923ac40 0781-7117 HUMAN PRESCRIPTION DRUG Calcipotriene Calcipotriene CREAM TOPICAL 20120727 ANDA ANDA200935 Sandoz Inc. CALCIPOTRIENE .05 mg/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 0781-7137_60a57065-4617-42e6-9d96-342abb2d4851 0781-7137 HUMAN PRESCRIPTION DRUG clobetasol propionate clobetasol propionate SHAMPOO TOPICAL 20111222 NDA AUTHORIZED GENERIC NDA021644 Sandoz Inc. CLOBETASOL PROPIONATE .05 g/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0781-7142_14a84173-d292-4b38-a48f-01756a77a01f 0781-7142 HUMAN PRESCRIPTION DRUG Adapalene Adapalene GEL TOPICAL 20140428 ANDA ANDA200298 Sandoz Inc. ADAPALENE 3 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 0781-7146_dfa3262e-eba4-424c-abb9-5d9b717c5604 0781-7146 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20130520 ANDA ANDA202496 Sandoz Inc. ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 3; .5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0781-7155_92b6fa0e-e8b7-49f7-8b6f-48aadc646bd4 0781-7155 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20110817 ANDA ANDA077839 Sandoz Inc. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 0781-7157_a76b5f61-64c0-4a1c-85a4-a7f743fb3250 0781-7157 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20110901 ANDA ANDA075693 Sandoz Inc. IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0781-7165_3339d333-2a5b-461b-98d9-5a4e4c2ad470 0781-7165 HUMAN PRESCRIPTION DRUG calcipotriene 0.005% and betamethasone dipropionate 0.064% calcipotriene 0.005% and betamethasone dipropionate 0.064% OINTMENT TOPICAL 20140331 ANDA ANDA201615 Sandoz Inc. BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE .5; 50 mg/g; ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0781-7171_9b162ae0-abbb-4578-9c60-a644bb14ca8b 0781-7171 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION ORAL 20140709 NDA AUTHORIZED GENERIC NDA050753 Sandoz Inc TOBRAMYCIN 300 mg/5mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0781-7240_85fc2080-6632-4999-ac95-9ac2db79de4f 0781-7240 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20041001 NDA NDA019813 Sandoz,Inc. FENTANYL 12.5 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0781-7241_85fc2080-6632-4999-ac95-9ac2db79de4f 0781-7241 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20041001 NDA NDA019813 Sandoz,Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0781-7242_85fc2080-6632-4999-ac95-9ac2db79de4f 0781-7242 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20041001 NDA NDA019813 Sandoz,Inc. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0781-7243_85fc2080-6632-4999-ac95-9ac2db79de4f 0781-7243 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20041001 NDA NDA019813 Sandoz,Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0781-7244_85fc2080-6632-4999-ac95-9ac2db79de4f 0781-7244 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20041001 NDA NDA019813 Sandoz,Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0781-9037_a78873f7-ff02-4ade-93ca-cd8a353a2123 0781-9037 HUMAN PRESCRIPTION DRUG cisatracurium besylate cisatracurium besylate INJECTION INTRAVENOUS 20130228 ANDA ANDA200154 Sandoz Inc CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0781-9038_e6202e14-f9d3-49fc-a6a2-14535aea0457 0781-9038 HUMAN PRESCRIPTION DRUG cisatracurium besylate cisatracurium besylate INJECTION INTRAVENOUS 20130228 ANDA ANDA200159 Sandoz Inc CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0781-9039_a78873f7-ff02-4ade-93ca-cd8a353a2123 0781-9039 HUMAN PRESCRIPTION DRUG cisatracurium besylate cisatracurium besylate INJECTION INTRAVENOUS 20130228 ANDA ANDA200154 Sandoz Inc CISATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 0781-9109_9013f9e2-b978-44bc-b029-d7ed2155fdfc 0781-9109 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19760106 ANDA ANDA061490 Sandoz Inc OXACILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9110_de254786-b20e-4739-9c50-e640400b50a7 0781-9110 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19861223 ANDA ANDA062737 Sandoz Inc OXACILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9111_9013f9e2-b978-44bc-b029-d7ed2155fdfc 0781-9111 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19760106 ANDA ANDA061490 Sandoz Inc OXACILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9112_de254786-b20e-4739-9c50-e640400b50a7 0781-9112 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19861223 ANDA ANDA062737 Sandoz Inc OXACILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9113_0b440be2-e869-437a-a1c1-fa92ee97c850 0781-9113 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19910509 ANDA ANDA061490 Sandoz Inc OXACILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9124_22f11fbf-0196-41e1-a068-58fe1e3f9777 0781-9124 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19840802 ANDA ANDA062527 Sandoz Inc NAFCILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9125_22f11fbf-0196-41e1-a068-58fe1e3f9777 0781-9125 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19840802 ANDA ANDA062527 Sandoz Inc NAFCILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9126_b3334d1d-d0bd-4bb7-b395-414cce3aa07b 0781-9126 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19840802 ANDA ANDA062527 Sandoz Inc NAFCILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9220_1afa9f7a-944c-4e34-ba51-120f68f2fcf9 0781-9220 HUMAN PRESCRIPTION DRUG Clindamycin in 5 Percent Dextrose Clindamycin in 5 Percent Dextrose INJECTION, SOLUTION INTRAVENOUS 20140301 ANDA ANDA201692 Sandoz Inc CLINDAMYCIN 6 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0781-9221_1afa9f7a-944c-4e34-ba51-120f68f2fcf9 0781-9221 HUMAN PRESCRIPTION DRUG Clindamycin in 5 Percent Dextrose Clindamycin in 5 Percent Dextrose INJECTION, SOLUTION INTRAVENOUS 20140301 ANDA ANDA201692 Sandoz Inc CLINDAMYCIN 12 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0781-9222_1afa9f7a-944c-4e34-ba51-120f68f2fcf9 0781-9222 HUMAN PRESCRIPTION DRUG Clindamycin in 5 Percent Dextrose Clindamycin in 5 Percent Dextrose INJECTION, SOLUTION INTRAVENOUS 20140301 ANDA ANDA201692 Sandoz Inc CLINDAMYCIN 18 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0781-9224_de2fcb2a-7895-48d0-bde7-2190a1df4c9f 0781-9224 HUMAN PRESCRIPTION DRUG Nafcillin Sodium Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050923 ANDA ANDA062732 Sandoz Inc NAFCILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9225_de2fcb2a-7895-48d0-bde7-2190a1df4c9f 0781-9225 HUMAN PRESCRIPTION DRUG Nafcillin Sodium Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050923 ANDA ANDA062732 Sandoz Inc NAFCILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9253_ca797312-2830-4683-9304-311c5c9fa39d 0781-9253 HUMAN PRESCRIPTION DRUG Azacitidine azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140327 NDA AUTHORIZED GENERIC NDA050794 Sandoz Inc AZACITIDINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 0781-9302_b9341c16-81f2-4d7e-a005-fee3ed03ebfb 0781-9302 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20120115 ANDA ANDA065461 Sandoz Inc TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0781-9303_b9341c16-81f2-4d7e-a005-fee3ed03ebfb 0781-9303 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20120115 ANDA ANDA065461 Sandoz Inc TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0781-9304_b9341c16-81f2-4d7e-a005-fee3ed03ebfb 0781-9304 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20120115 ANDA ANDA065461 Sandoz Inc TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 0781-9314_dc5372d7-b15a-4239-9b06-79939615e33c 0781-9314 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION INTRAVENOUS 20110906 NDA AUTHORIZED GENERIC NDA022434 Sandoz Inc ARGATROBAN 1 mg/mL 0781-9324_31105e1d-2504-424a-affb-78877470b247 0781-9324 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION INTRAVENOUS 20100927 ANDA ANDA090125 Sandoz Inc. NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0781-9326_b559e312-c46f-4456-afeb-b4168c3884dc 0781-9326 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Sandoz Inc CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-9327_b559e312-c46f-4456-afeb-b4168c3884dc 0781-9327 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Sandoz Inc CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-9328_b559e312-c46f-4456-afeb-b4168c3884dc 0781-9328 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Sandoz Inc CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-9329_b559e312-c46f-4456-afeb-b4168c3884dc 0781-9329 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Sandoz Inc CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-9330_e17425d0-6e96-41fe-a2bc-dca5954a70d3 0781-9330 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050517 20150630 ANDA ANDA065168 Sandoz Inc CEFTRIAXONE SODIUM 10 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-9338_9925032f-d1ea-4da0-babe-eb1b1d7855b7 0781-9338 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 19881209 ANDA ANDA062831 Sandoz Inc CEFAZOLIN SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 0781-9401_68d55f37-bd10-4806-901a-1ad4a48dfae2 0781-9401 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 125 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9402_68d55f37-bd10-4806-901a-1ad4a48dfae2 0781-9402 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9404_68d55f37-bd10-4806-901a-1ad4a48dfae2 0781-9404 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9407_68d55f37-bd10-4806-901a-1ad4a48dfae2 0781-9407 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9408_68d55f37-bd10-4806-901a-1ad4a48dfae2 0781-9408 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9409_68660ce7-bc27-40ec-9a14-1fd1b5fbe53d 0781-9409 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 10 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9412_f77db491-31c4-4a7c-a114-0f3244c97090 0781-9412 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19870219 ANDA ANDA062738 Sandoz Inc AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0781-9413_f77db491-31c4-4a7c-a114-0f3244c97090 0781-9413 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19870219 ANDA ANDA062738 Sandoz Inc AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 0785-6350_339707e0-0349-4ef4-b15e-8787d2f20661 0785-6350 HUMAN PRESCRIPTION DRUG Lorcet 10/650 hydrocodone bitartrate and acetaminophen TABLET ORAL 19841231 20150330 ANDA ANDA081223 Forest Laboratories, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 0799-0001_8b2daa6d-6f4c-413d-935f-f8384ff07c95 0799-0001 HUMAN OTC DRUG Calmoseptine Zinc Oxide and menthol OINTMENT TOPICAL 19500801 OTC MONOGRAPH FINAL part347 Calmoseptine Inc. MENTHOL; ZINC OXIDE .44; 20.6 g/100g; g/100g 0813-0202_9e230010-696b-42ff-af18-768dce0b5c87 0813-0202 HUMAN PRESCRIPTION DRUG O-Cal Prenatal Vitamin Vitamin A, Ascorbic Acid, Cholecalciferol, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, Riboflavin, Niacin, Pyridoxine, Folic Acid, Cyanocobalamin, Calcium, FERROUS FUMARATE, Iodine, Magnesium, Zinc, and Copper TABLET ORAL 20020123 UNAPPROVED DRUG OTHER Pharmics, Inc. .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; IODINE; MAGNESIUM; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; ZINC 30; 70; 200; 400; 2; 12; 15; 1; 150; 100; 17; 12; 1.6; 1.5; 2500; 15 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 0813-0799_226ac5f4-e05a-4b52-9f66-aa2a2a7009f3 0813-0799 HUMAN PRESCRIPTION DRUG Fem pH Acetic Acid and Oxyquinoline sulfate JELLY VAGINAL 19990715 UNAPPROVED DRUG OTHER Pharmics, Inc. ACETIC ACID; OXYQUINOLINE SULFATE .009; .00025 g/g; g/g 0813-9616_507a2816-6da4-4b00-af8f-8be0178cb698 0813-9616 HUMAN PRESCRIPTION DRUG O-Cal FA multivitamin VITAMIN A ACETATE, Ascorbic Acid, Cholecalciferol, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, Riboflavin, Niacin, Pyridoxine, Folic Acid, Cyanocobalamin, CALCIUM CARBONATE, FERROUS FUMARATE, Iodine, Magnesium, Zinc, Copper, and Sodium Fluoride TABLET ORAL 19700115 UNAPPROVED DRUG OTHER Pharmics, Inc. .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; IODINE; MAGNESIUM; NIACIN; PYRIDOXINE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC 30; 90; 200; 400; 2; 12; 27; 1; 150; 100; 20; 4; 3; .5; 3; 2500; 15 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 0832-0038_3791918d-09fb-4e25-b6d2-1e6e54759f23 0832-0038 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20111107 ANDA ANDA074625 Upsher-Smith Laboratories, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0832-0042_f4ee5458-3acb-4eb9-a927-9807b60a9b6e 0832-0042 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20070709 ANDA ANDA077759 Upsher-Smith Laboratories, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0832-0043_f4ee5458-3acb-4eb9-a927-9807b60a9b6e 0832-0043 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20070709 ANDA ANDA077759 Upsher-Smith Laboratories, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0832-0044_f4ee5458-3acb-4eb9-a927-9807b60a9b6e 0832-0044 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20070709 ANDA ANDA077759 Upsher-Smith Laboratories, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0832-0086_29955938-cd02-4589-9df7-3bab841b1c58 0832-0086 HUMAN PRESCRIPTION DRUG Androxy fluoxymesterone TABLET ORAL 19831021 ANDA ANDA088342 Upsher-Smith Laboratories Inc. FLUOXYMESTERONE 10 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0832-0111_c8a67d92-ac44-46d0-be2a-1dc4c9fd07f8 0832-0111 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride amantadine hydrochloride TABLET ORAL 20111215 ANDA ANDA076186 Upsher-Smith Laboratories, Inc AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 0832-0225_0bd8aafd-fc58-4286-8937-e91cde859b74 0832-0225 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20130630 ANDA ANDA202104 Upsher-Smith Laboratories, Inc. MORPHINE SULFATE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0832-0226_0bd8aafd-fc58-4286-8937-e91cde859b74 0832-0226 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20130630 ANDA ANDA202104 Upsher-Smith Laboratories, Inc. MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0832-0227_0bd8aafd-fc58-4286-8937-e91cde859b74 0832-0227 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20130630 ANDA ANDA202104 Upsher-Smith Laboratories, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0832-0228_0bd8aafd-fc58-4286-8937-e91cde859b74 0832-0228 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20130630 ANDA ANDA202104 Upsher-Smith Laboratories, Inc. MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0832-0229_0bd8aafd-fc58-4286-8937-e91cde859b74 0832-0229 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20130630 ANDA ANDA202104 Upsher-Smith Laboratories, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0832-0230_0bd8aafd-fc58-4286-8937-e91cde859b74 0832-0230 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20130630 ANDA ANDA202104 Upsher-Smith Laboratories, Inc. MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0832-0233_0bd8aafd-fc58-4286-8937-e91cde859b74 0832-0233 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20130630 ANDA ANDA202104 Upsher-Smith Laboratories, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 0832-0300_bf9023e5-3b39-419e-9fd7-b460a24794b7 0832-0300 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110808 ANDA ANDA083386 Upsher-Smith Laboratories, Inc. CHLORPROMAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0832-0301_bf9023e5-3b39-419e-9fd7-b460a24794b7 0832-0301 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084112 Upsher-Smith Laboratories, Inc. CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0832-0302_bf9023e5-3b39-419e-9fd7-b460a24794b7 0832-0302 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084113 Upsher-Smith Laboratories, Inc. CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0832-0303_bf9023e5-3b39-419e-9fd7-b460a24794b7 0832-0303 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084114 Upsher-Smith Laboratories, Inc. CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0832-0304_bf9023e5-3b39-419e-9fd7-b460a24794b7 0832-0304 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084115 Upsher-Smith Laboratories, Inc. CHLORPROMAZINE HYDROCHLORIDE 200 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0832-0400_5884414a-b604-458e-bbcc-617a17fbf923 0832-0400 HUMAN PRESCRIPTION DRUG Zaleplon zaleplon CAPSULE, GELATIN COATED ORAL 20080606 ANDA ANDA078706 Upsher-Smith Laboratories, Inc. ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 0832-0401_5884414a-b604-458e-bbcc-617a17fbf923 0832-0401 HUMAN PRESCRIPTION DRUG Zaleplon zaleplon CAPSULE, GELATIN COATED ORAL 20080606 ANDA ANDA078706 Upsher-Smith Laboratories, Inc. ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 0832-0465_2336509a-11f4-429c-b94f-7746050b6680 0832-0465 HUMAN PRESCRIPTION DRUG Nyamyc Nystatin POWDER CUTANEOUS 20050503 ANDA ANDA065183 Upsher-Smith Laboratories Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 0832-0510_55185599-d792-4c83-b3b5-b15f345f3a7f 0832-0510 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100124 ANDA ANDA040633 Upsher-Smith Laboratories, Inc. BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0832-0511_55185599-d792-4c83-b3b5-b15f345f3a7f 0832-0511 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100124 ANDA ANDA040634 Upsher-Smith Laboratories, Inc. BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0832-0512_55185599-d792-4c83-b3b5-b15f345f3a7f 0832-0512 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100124 ANDA ANDA040635 Upsher-Smith Laboratories, Inc. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0832-0513_55185599-d792-4c83-b3b5-b15f345f3a7f 0832-0513 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100124 ANDA ANDA040636 Upsher-Smith Laboratories, Inc. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0832-0600_d667d0e9-4f3d-4d73-ac30-2b1d742ffa78 0832-0600 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078525 Upsher-Smith Laboratories, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0832-0601_d667d0e9-4f3d-4d73-ac30-2b1d742ffa78 0832-0601 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078525 Upsher-Smith Laboratories, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0832-0602_d667d0e9-4f3d-4d73-ac30-2b1d742ffa78 0832-0602 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078525 Upsher-Smith Laboratories, Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0832-0603_d667d0e9-4f3d-4d73-ac30-2b1d742ffa78 0832-0603 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078525 Upsher-Smith Laboratories, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0832-0611_b88b236d-db63-4747-a798-2edb450044dc 0832-0611 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 Upsher-Smith Laboratories, Inc CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0832-0620_4b856e4a-7939-4995-8186-8b7af8f45d18 0832-0620 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20060905 ANDA ANDA040684 Upsher-Smith Laboratories, Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0832-0707_a2492338-cff8-432b-9703-150057cf8037 0832-0707 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, COATED ORAL 20101117 ANDA ANDA078499 Upsher-Smith Laboratories, Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0832-0708_a2492338-cff8-432b-9703-150057cf8037 0832-0708 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, COATED ORAL 20101117 ANDA ANDA078499 Upsher-Smith Laboratories, Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0832-0709_a2492338-cff8-432b-9703-150057cf8037 0832-0709 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, COATED ORAL 20101117 ANDA ANDA078499 Upsher-Smith Laboratories, Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0832-0710_a2492338-cff8-432b-9703-150057cf8037 0832-0710 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, COATED ORAL 20101117 ANDA ANDA078499 Upsher-Smith Laboratories, Inc. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0832-0900_a2e5fb08-d7c9-46f3-9a3f-6f9f1e386262 0832-0900 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20140925 ANDA ANDA074979 Upsher-Smith Laboratories, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0832-0901_a2e5fb08-d7c9-46f3-9a3f-6f9f1e386262 0832-0901 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20140925 ANDA ANDA074979 Upsher-Smith Laboratories, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0832-0902_a2e5fb08-d7c9-46f3-9a3f-6f9f1e386262 0832-0902 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20140925 ANDA ANDA074979 Upsher-Smith Laboratories, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0832-0910_c525f823-3fba-406f-93eb-0406c9bd7727 0832-0910 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070103 ANDA ANDA071403 Upsher-Smith Laboratories, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0832-0911_c525f823-3fba-406f-93eb-0406c9bd7727 0832-0911 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 Upsher-Smith Laboratories, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0832-0912_c525f823-3fba-406f-93eb-0406c9bd7727 0832-0912 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070108 ANDA ANDA071141 Upsher-Smith Laboratories, Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0832-1008_3ecdaaa8-6e7c-4905-9b42-bfcefffd1bf9 0832-1008 HUMAN PRESCRIPTION DRUG Valproic Acid valproic acid CAPSULE ORAL 19911029 ANDA ANDA073229 Upsher-Smith Laboratories, Inc VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0832-1008_f7627783-1b6c-484c-aae8-ddc4a33dca25 0832-1008 HUMAN PRESCRIPTION DRUG Valproic Acid valproic acid CAPSULE ORAL 19911029 ANDA ANDA073229 Upsher-Smith Laboratories, Inc VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0832-1015_a85f9349-6bd7-454f-a948-0d0e02091da0 0832-1015 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride amantadine hydrochloride CAPSULE, GELATIN COATED ORAL 20110915 ANDA ANDA070589 Upsher-Smith Laboratories, Inc AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 0832-1024_b119f3e3-bf09-485e-9687-57d284f7712f 0832-1024 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20101020 ANDA ANDA074584 Upsher-Smith Laboratories, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 0832-1025_b119f3e3-bf09-485e-9687-57d284f7712f 0832-1025 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20101020 ANDA ANDA074584 Upsher-Smith Laboratories, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 0832-1071_af6cc3ea-3459-4072-b4f6-7fc1de04ff33 0832-1071 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140707 NDA AUTHORIZED GENERIC NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0832-1072_af6cc3ea-3459-4072-b4f6-7fc1de04ff33 0832-1072 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140707 NDA AUTHORIZED GENERIC NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0832-1073_af6cc3ea-3459-4072-b4f6-7fc1de04ff33 0832-1073 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140707 NDA AUTHORIZED GENERIC NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0832-1074_af6cc3ea-3459-4072-b4f6-7fc1de04ff33 0832-1074 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140707 NDA AUTHORIZED GENERIC NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0832-1075_af6cc3ea-3459-4072-b4f6-7fc1de04ff33 0832-1075 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140707 NDA AUTHORIZED GENERIC NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0832-1080_a4391943-f5c8-42da-accc-5165415acd2d 0832-1080 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 19961212 ANDA ANDA040103 Upsher-Smith Laboratories, Inc. BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0832-1081_a4391943-f5c8-42da-accc-5165415acd2d 0832-1081 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 19961212 ANDA ANDA040103 Upsher-Smith Laboratories, Inc. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0832-1082_a4391943-f5c8-42da-accc-5165415acd2d 0832-1082 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 19961212 ANDA ANDA040103 Upsher-Smith Laboratories, Inc. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0832-1120_7690f5ea-9552-43cd-b095-92b3c51b0db6 0832-1120 HUMAN PRESCRIPTION DRUG Testosterone Testosterone GEL TOPICAL 20140616 NDA AUTHORIZED GENERIC NDA204399 Upsher-Smith Laboratories, Inc. TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0832-1121_7690f5ea-9552-43cd-b095-92b3c51b0db6 0832-1121 HUMAN PRESCRIPTION DRUG Testosterone Testosterone GEL, METERED TOPICAL 20140616 NDA AUTHORIZED GENERIC NDA204399 Upsher-Smith Laboratories, Inc. TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 0832-1211_946e5e05-45ab-489a-8fb8-9b7966e24135 0832-1211 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0832-1212_946e5e05-45ab-489a-8fb8-9b7966e24135 0832-1212 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, Inc. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0832-1213_946e5e05-45ab-489a-8fb8-9b7966e24135 0832-1213 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, Inc. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0832-1214_946e5e05-45ab-489a-8fb8-9b7966e24135 0832-1214 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, Inc. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0832-1215_946e5e05-45ab-489a-8fb8-9b7966e24135 0832-1215 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0832-1216_946e5e05-45ab-489a-8fb8-9b7966e24135 0832-1216 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0832-1217_946e5e05-45ab-489a-8fb8-9b7966e24135 0832-1217 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, Inc. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0832-1218_946e5e05-45ab-489a-8fb8-9b7966e24135 0832-1218 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, Inc. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0832-1219_946e5e05-45ab-489a-8fb8-9b7966e24135 0832-1219 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, Inc. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 0832-2012_062b646c-5ad9-4836-9e47-8678e1f2da7e 0832-2012 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19870218 ANDA ANDA071293 Upsher-Smith Laboratories, Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 0832-7122_35edc7d5-f2d0-48e8-b98a-5f8bc2378865 0832-7122 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20140321 ANDA ANDA078182 Upsher-Smith Laboratories, Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0832-7123_35edc7d5-f2d0-48e8-b98a-5f8bc2378865 0832-7123 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20140321 ANDA ANDA078182 Upsher-Smith Laboratories, Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0832-7124_35edc7d5-f2d0-48e8-b98a-5f8bc2378865 0832-7124 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20140321 ANDA ANDA078182 Upsher-Smith Laboratories, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0869-0004_724d9a87-09d3-4025-b0a5-82635039cf16 0869-0004 HUMAN OTC DRUG Kids Anticavity Kids Anticavity MOUTHWASH ORAL 20040406 OTC MONOGRAPH FINAL part355 Vi Jon SODIUM FLUORIDE .02 kg/100L 0869-0050_3445e3c0-d88e-4002-8f5b-2d1d4f1c2ecf 0869-0050 HUMAN OTC DRUG Povidone Iodine Solution First Aid Antiseptic POVIDONE-IODINE SOLUTION TOPICAL 20090507 OTC MONOGRAPH FINAL part333E Vi Jon POVIDONE-IODINE 10 kg/100L 0869-0063_77e9a1e6-32fa-48d0-a769-9c2626ebe5b0 0869-0063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19890715 OTC MONOGRAPH FINAL part347 Vi Jon FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL 0869-0072_7cdcb44f-ffdb-4124-ab0f-546aae6cb409 0869-0072 HUMAN OTC DRUG Antiseptic Eucalyptol MOUTHWASH ORAL 19880720 OTC MONOGRAPH NOT FINAL part356 Vi Jon, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .042; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 0869-0078_8925d907-2f09-480d-a753-962b487f3708 0869-0078 HUMAN OTC DRUG Castor Oil Castor Oil LIQUID ORAL 19890715 OTC MONOGRAPH NOT FINAL part334 Vi-Jon CASTOR OIL 1 g/mL 0869-0163_f72d827f-1561-490d-95ac-a672850feeaf 0869-0163 HUMAN OTC DRUG Anticavity SODIUM FLUORIDE MOUTHWASH ORAL 20060513 OTC MONOGRAPH FINAL part355 Swan SODIUM FLUORIDE 999.5 mL/100L 0869-0211_8d55ec8d-2a28-485a-8e7b-c8853a25a9b2 0869-0211 HUMAN OTC DRUG Isopropyl ISOPROPYL ALCOHOL LIQUID TOPICAL 20040930 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ISOPROPYL ALCOHOL 924 mg/mL 0869-0213_79249f1b-3aad-434a-b306-a6c7f896e35f 0869-0213 HUMAN OTC DRUG Anticavity Sodium Fluoride RINSE ORAL 20010621 OTC MONOGRAPH FINAL part355 Vi Jon SODIUM FLUORIDE .05 kg/100L 0869-0218_6325f77f-f6d6-4dfd-ac77-05bdacdb2722 0869-0218 HUMAN OTC DRUG Clear Anti Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 19940507 OTC MONOGRAPH FINAL part347 /Vi-Jon PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL 0869-0299_50ff9433-a36c-4dd4-9345-7cd0c3b84a53 0869-0299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 19950105 OTC MONOGRAPH NOT FINAL part356 Vi-Jon CETYLPYRIDINIUM CHLORIDE .07 kg/100L 0869-0318_12793dd5-ef29-4633-ae5f-fb6216af66aa 0869-0318 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 19890715 OTC MONOGRAPH NOT FINAL part356 Vi-Jon EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 0869-0370_d8faad1e-f930-40a7-a1dd-717a65cc660c 0869-0370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20140804 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 70 mL/100mL 0869-0434_7287bf5d-1b17-49e9-9174-573beae379a6 0869-0434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130610 OTC MONOGRAPH NOT FINAL part356 Vi-Jon EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 0869-0492_62a8623b-6501-4af9-94d1-9fb3f0b724a6 0869-0492 HUMAN OTC DRUG Foaming Hand Sanitizer Benzalkonium chloride LIQUID TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333A Vi-Jon BENZALKONIUM CHLORIDE 1.3 mg/mL 0869-0551_20f4595b-1c25-4945-9953-6b5c3381557f 0869-0551 HUMAN OTC DRUG Medicated menthol, zinc oxide POWDER TOPICAL 20030812 OTC MONOGRAPH NOT FINAL part348 Vi-Jon MENTHOL; ZINC OXIDE 1.5; 10 mg/g; mg/g 0869-0602_1aa93cc4-a3ac-4ac3-bfb6-2bc5c994ab1c 0869-0602 HUMAN OTC DRUG Epsom Sal Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 19980715 OTC MONOGRAPH FINAL part334 Vi-Jon MAGNESIUM SULFATE 1 g/g 0869-0664_fc4c9048-ebea-4975-83db-6b3db3aaa4b2 0869-0664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19920715 OTC MONOGRAPH NOT FINAL part356 Vi-Jon EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 0869-0667_cdaa364a-7289-43a1-89ff-270ea60662e7 0869-0667 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 19890715 OTC MONOGRAPH FINAL part334 Vi Jon, Inc MAGNESIUM CITRATE 1.745 g/29.6mL 0869-0686_17abe1f9-f210-4e55-9f09-ffb77448710b 0869-0686 HUMAN OTC DRUG Citroma Magnesium Citrate Citroma Magnesium Citrate LIQUID ORAL 19790619 OTC MONOGRAPH NOT FINAL part334 Vi-Jon MAGNESIUM CITRATE 1.745 g/29.6mL 0869-0693_a8a4d677-0c1b-4dbf-aa64-c0f7f0643917 0869-0693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19890715 OTC MONOGRAPH NOT FINAL part334 Vi-Jon MAGNESIUM CITRATE 1.745 g/29.6mL 0869-0804_7e31360d-c184-46a3-8a69-4261101de4ba 0869-0804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl alcohol LIQUID TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc ISOPROPYL ALCOHOL 91 kg/100L 0869-0810_2fc8eb14-de54-47de-b149-279ce1805ad8 0869-0810 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ISOPROPYL ALCOHOL 70 L/100L 0869-0822_e40982f2-b10d-4527-b734-1920a9372f3f 0869-0822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 19980129 OTC MONOGRAPH FINAL part347 Vi-Jon WITCH HAZEL 86 kg/100L 0869-0831_ad7c15a7-84da-40e4-bc12-a002431800ba 0869-0831 HUMAN OTC DRUG oil Mineral Oil OIL ORAL 19890715 OTC MONOGRAPH NOT FINAL part334 Vi-Jon MINERAL OIL 1 mg/mL 0869-0845_48b7d05d-2d64-4a73-9875-5ea2217d694c 0869-0845 HUMAN OTC DRUG 70% Rubbing Isopropyl Alcohol LIQUID TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ISOPROPYL ALCOHOL 500 mg/mL 0869-0864_2829fec2-5852-4044-ab19-dd06ea9deca3 0869-0864 HUMAN OTC DRUG 50% Rubbing Isopropyl Alcohol LIQUID TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ISOPROPYL ALCOHOL 500 mg/mL 0869-0871_33a29935-f545-46d8-8648-0b039159e210 0869-0871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Vi-Jon HYDROGEN PEROXIDE 30 mg/mL 0869-0876_05ecb809-28fa-46d4-b1bc-7785640b9a92 0869-0876 HUMAN OTC DRUG Rubbing Ethyl Alcohol LIQUID TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 610 mg/mL 0869-0893_973a46bd-2640-4b6b-8627-6fb47048ddb9 0869-0893 HUMAN OTC DRUG Anticavity Fluoride Rinse Anticavity Fluoride MOUTHWASH ORAL 20090916 OTC MONOGRAPH FINAL part355 Vi Jon SODIUM FLUORIDE .0221 kg/100L 0884-0293_250d0a66-01d1-4aba-8f24-4cb4ca529fda 0884-0293 HUMAN OTC DRUG fungoid tincture miconazole nitrate TINCTURE TOPICAL 19940101 OTC MONOGRAPH FINAL part333C Pedinol Pharmacal, Inc. MICONAZOLE NITRATE 20 mg/mL 0884-0396_ac4f1a20-e645-4c89-af06-989cf780f6ac 0884-0396 HUMAN PRESCRIPTION DRUG Pedi-Dri Nystatin POWDER TOPICAL 19960816 20150630 ANDA ANDA064118 Pedinol Pharmacal, Inc. NYSTATIN 100000 [USP&apos'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 0884-0763_1b0bebd2-ab7f-4d13-84fc-9b1c5b97d96f 0884-0763 HUMAN PRESCRIPTION DRUG Gris-PEG griseofulvin TABLET, FILM COATED ORAL 19750416 NDA NDA050475 PEDINOL PHARMACAL INC. GRISEOFULVIN 125 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 0884-0773_1b0bebd2-ab7f-4d13-84fc-9b1c5b97d96f 0884-0773 HUMAN PRESCRIPTION DRUG Gris-PEG griseofulvin TABLET, FILM COATED ORAL 19750416 NDA NDA050475 PEDINOL PHARMACAL INC. GRISEOFULVIN 250 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 0884-1706_a59ce8b4-9cf3-46a2-b60d-27468a44b565 0884-1706 HUMAN OTC DRUG Pedi-Boro Soak Paks aluminum sulfate tetradecahydrate, calcium acetate monohydrate POWDER, FOR SOLUTION TOPICAL 20130115 OTC MONOGRAPH FINAL part347 Pedinol Pharmacal, Inc. ALUMINUM ACETATE 615 mg/1 0884-2592_d370f7d5-5eca-412f-834f-1029001829ae 0884-2592 HUMAN OTC DRUG Salactic Film salicylic acid LIQUID TOPICAL 19910101 OTC MONOGRAPH FINAL part358B Pedinol Pharmacal, Inc. SALICYLIC ACID 170 mg/mL 0884-2893_3aa69d68-7a22-4a55-9682-ecc14540984a 0884-2893 HUMAN OTC DRUG Castellani Paint Phenol LIQUID TOPICAL 19720101 OTC MONOGRAPH NOT FINAL part333A Pedinol Pharmacal, Inc. PHENOL 15 mg/mL 0884-2993_bf6845e5-16f3-4828-bfbf-2bc2596a02f3 0884-2993 HUMAN OTC DRUG Castellani Paint Phenol LIQUID TOPICAL 19720101 OTC MONOGRAPH NOT FINAL part333A Pedinol Pharmacal, Inc. PHENOL 15 mg/mL 0884-5192_3c8552fd-5f5d-4180-9d6f-752d94951925 0884-5192 HUMAN OTC DRUG Sal-Plant Gel salicylic acid GEL TOPICAL 19910101 OTC MONOGRAPH FINAL part358B Pedinol Pharmacal, Inc. SALICYLIC ACID .17 g/g 0884-5493_b250f4a4-6fdf-4a91-b214-4447aec3bb33 0884-5493 HUMAN OTC DRUG Fungoid Tincture Treatment Kit miconazole nitrate KIT 19940101 OTC MONOGRAPH FINAL part333C Pedinol Pharmacal, Inc. 0884-8211_3f0e3f39-b46e-435a-a408-f24149522916 0884-8211 HUMAN OTC DRUG Fungoid-D TOLNAFTATE CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part333C Pedinol Pharmacal, Inc. TOLNAFTATE 1 g/100g 0884-8411_1b332091-2901-47ea-a359-6de7db4001ad 0884-8411 HUMAN PRESCRIPTION DRUG Pedipirox-4 Nail Kit Ciclopirox KIT 20120203 ANDA ANDA078270 Pedinol Pharmacal Inc. 0884-8411_7bc04fb5-4b00-4bbd-971b-5c2ac7bb5320 0884-8411 HUMAN PRESCRIPTION DRUG Pedipirox-4 Nail Kit Ciclopirox KIT 20120203 20150430 ANDA ANDA078270 Pedinol Pharmacal, Inc. 0904-0004_a1af3bde-c2d1-41bd-affd-6926bedefd1c 0904-0004 HUMAN OTC DRUG MI-ACID REGULAR STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part331 MAJOR Pharmaceuticals Inc. ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 0904-0005_137b248b-2e67-4ba3-99b3-a947824bdb30 0904-0005 HUMAN OTC DRUG MI-ACID MAXIMUM STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part331 MAJOR Pharmaceuticals Inc. ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 0904-0012_45d59b05-38e8-44b1-a08c-b40f0760db30 0904-0012 HUMAN OTC DRUG Allergy Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals CHLORPHENIRAMINE MALEATE 4 mg/1 0904-0049_e9af6959-d37e-4e7c-a355-d31e6a94f5ab 0904-0049 HUMAN OTC DRUG formula em Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 19940415 UNAPPROVED DRUG OTHER Major Pharmaceuticals DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 0904-0053_87abb742-f161-49b7-b2fa-473eb6b4694e 0904-0053 HUMAN OTC DRUG Tussin DM Dextromethorphan Hydrobromide and GUAIFENESIN LIQUID ORAL 20090107 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 0904-0061_27908c86-d038-4f22-bb5b-7c912d94957c 0904-0061 HUMAN OTC DRUG ROBAFEN COUGH FORMULA Guaifenesin SYRUP ORAL 20120815 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals GUAIFENESIN 100 mg/5mL 0904-0195_90275a6f-5479-4ddb-b71e-3295c947deba 0904-0195 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 Major Pharmaceuticals DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0904-0201_a02a0e30-c7b2-4621-864c-2c5a8b6a7498 0904-0201 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20090610 ANDA ANDA085968 Major Pharmaceuticals AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0904-0202_a02a0e30-c7b2-4621-864c-2c5a8b6a7498 0904-0202 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20090610 ANDA ANDA085968 Major Pharmaceuticals AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0904-0250_e159d7df-ffa3-447e-b00f-d2e5d8fb9074 0904-0250 HUMAN OTC DRUG Aprodine Pseudoephedrine HCl and Tripolidine TABLET, FILM COATED ORAL 19930109 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 60; 2.5 mg/1; mg/1 0904-0304_8f00f4c0-2970-482d-a22b-8a8460f9f014 0904-0304 HUMAN OTC DRUG Magnesium Citrate Magnesium Citrate LIQUID ORAL 20090731 OTC MONOGRAPH NOT FINAL part334 Major MAGNESIUM CITRATE 2.62 g/100mL 0904-0314_f1617ec5-1514-42e2-a05f-a0824cd168de 0904-0314 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090715 OTC MONOGRAPH NOT FINAL part356 Major HYDROGEN PEROXIDE 2.65 mL/100mL 0904-0357_4b87e9e9-9736-4918-8780-fa7448b39fb2 0904-0357 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20070320 ANDA ANDA040786 Major Pharmaceuticals HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0904-0358_4b87e9e9-9736-4918-8780-fa7448b39fb2 0904-0358 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20070320 ANDA ANDA040787 Major Pharmaceuticals HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0904-0359_4b87e9e9-9736-4918-8780-fa7448b39fb2 0904-0359 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20070320 ANDA ANDA040788 Major Pharmaceuticals HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 0904-0411_b22fa09b-7443-4891-8677-1ecc5b4b01ce 0904-0411 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20040304 ANDA ANDA071972 Major Pharmaceuticals PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-0427_b8fe4603-402a-415e-9269-5542977991e2 0904-0427 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19841101 ANDA ANDA062396 Major Pharmaceuticals DOXYCYCLINE HYCLATE 50 mg/1 0904-0428_92c31d61-513e-4d0b-9bbf-0fd3d41ffef9 0904-0428 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20080805 ANDA ANDA062396 Major Pharmaceuticals DOXYCYCLINE HYCLATE 100 mg/1 0904-0430_c0a35645-9c49-46c6-af8c-8c33e358b316 0904-0430 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20040803 ANDA ANDA065095 Major Pharmaceuticals DOXYCYCLINE HYCLATE 100 mg/1 0904-0478_37d4b88e-89ba-48fa-aba3-302fe6b3c91f 0904-0478 HUMAN OTC DRUG Mintox Plus Tabs Aluminum Hydroxide, Magnesium Hydroxide, Simethicone TABLET, CHEWABLE ORAL 20070314 OTC MONOGRAPH FINAL part331 Major Pharmaceuticals ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 25; 200 mg/1; mg/1; mg/1 0904-0560_b15567de-9333-48b3-b609-b192be068925 0904-0560 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20050407 ANDA ANDA084903 Major Pharmaceuticals PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0904-0643_83d386b4-cc36-454e-8208-8fe4bf1d2883 0904-0643 HUMAN PRESCRIPTION DRUG Nitro-Time Nitroglycerin CAPSULE ORAL 20040129 UNAPPROVED DRUG OTHER Major Pharmaceuticals NITROGLYCERIN 2.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0904-0644_83d386b4-cc36-454e-8208-8fe4bf1d2883 0904-0644 HUMAN PRESCRIPTION DRUG Nitro-Time Nitroglycerin CAPSULE ORAL 20040129 UNAPPROVED DRUG OTHER Major Pharmaceuticals NITROGLYCERIN 6.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0904-0647_83d386b4-cc36-454e-8208-8fe4bf1d2883 0904-0647 HUMAN PRESCRIPTION DRUG Nitro-Time Nitroglycerin CAPSULE ORAL 20040129 UNAPPROVED DRUG OTHER Major Pharmaceuticals NITROGLYCERIN 9 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0904-0722_11969a53-61da-436b-853d-f0f2a9f1495d 0904-0722 HUMAN OTC DRUG Tolnaftate TOLNAFTATE CREAM TOPICAL 20100211 OTC MONOGRAPH FINAL part333C Major Pharmaceuticals TOLNAFTATE 10 mg/g 0904-0726_ffe1e938-824c-4f7d-a294-59ebf280c269 0904-0726 HUMAN OTC DRUG TOLNAFTATE ANTIFUNGAL TOLNAFTATE POWDER TOPICAL 20111101 OTC MONOGRAPH FINAL part333C MAJOR Pharmaceuticals Inc. TOLNAFTATE .45 g/45g 0904-0734_fc9f0a8b-a4d0-4b83-8aed-bbbe25101c76 0904-0734 HUMAN OTC DRUG TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sulfate OINTMENT TOPICAL 20110601 OTC MONOGRAPH FINAL part333B Major BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 0904-0788_ed5bf111-cd57-4002-b78c-5ce06e6d983f 0904-0788 HUMAN OTC DRUG MILK OF MAGNESIA ORIGINAL magnesium hydroxide LIQUID ORAL 20101208 OTC MONOGRAPH FINAL part334 MAJOR Pharmaceuticals Inc. MAGNESIUM HYDROXIDE 1200 mg/15mL 0904-0789_a608e576-eb82-4304-a5fc-64e115d3d020 0904-0789 HUMAN OTC DRUG MILK OF MAGNESIA MINT magnesium hydroxide LIQUID ORAL 20110606 OTC MONOGRAPH FINAL part334 MAJOR Pharmaceuticals Inc. MAGNESIUM HYDROXIDE 1200 mg/15mL 0904-1007_080afef4-d8e2-4a8c-a876-711c4da57915 0904-1007 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride SOLUTION ORAL 20081230 UNAPPROVED DRUG OTHER Major Pharmaceuticals POTASSIUM CHLORIDE 40 meq/30mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0904-1055_73677741-10d7-4abe-95c9-1b498485d1fd 0904-1055 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20060223 ANDA ANDA072264 Major Pharmaceuticals BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0904-1056_73677741-10d7-4abe-95c9-1b498485d1fd 0904-1056 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20060216 ANDA ANDA072265 Major Pharmaceuticals BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0904-1057_73677741-10d7-4abe-95c9-1b498485d1fd 0904-1057 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20060216 ANDA ANDA072266 Major Pharmaceuticals BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 0904-1086_a12e9b08-3f1d-4c27-8855-73ba68d3e2fc 0904-1086 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE dipyridamole TABLET, FILM COATED ORAL 20081030 ANDA ANDA040733 Major Pharmaceuticals DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0904-1087_a12e9b08-3f1d-4c27-8855-73ba68d3e2fc 0904-1087 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE dipyridamole TABLET, FILM COATED ORAL 20081030 ANDA ANDA040733 Major Pharmaceuticals DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0904-1088_a12e9b08-3f1d-4c27-8855-73ba68d3e2fc 0904-1088 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE dipyridamole TABLET, FILM COATED ORAL 20081030 ANDA ANDA040733 Major Pharmaceuticals DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 0904-1102_75921260-fe19-4670-8c2f-988f0c3bd13e 0904-1102 HUMAN OTC DRUG Major Povidone Iodine POVIDONE-IODINE OINTMENT TOPICAL 20060814 OTC MONOGRAPH FINAL part333C Major Pharmaceuticals POVIDONE-IODINE 100 mg/g 0904-1103_91be52a6-3202-4628-a3b0-7bdaf920cbf8 0904-1103 HUMAN OTC DRUG povidone iodine povidone iodine SOLUTION TOPICAL 20111221 OTC MONOGRAPH FINAL part333C Major Pharmaceuticals POVIDONE-IODINE 100 mg/mL 0904-1152_ea9e59ee-c2db-4fc4-9a64-75d0a9ffe51f 0904-1152 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20000818 NDA AUTHORIZED GENERIC NDA021243 Major Pharmaceuticals SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 0904-1228_5e07cfcd-dfc0-464e-b9fd-7da8564d10e1 0904-1228 HUMAN OTC DRUG banophen Diphenhydramine HCl LIQUID ORAL 20061120 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 0904-1250_701e7e55-b806-485c-b377-fbb5fcd93f81 0904-1250 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 19980803 UNAPPROVED DRUG OTHER Major Pharmaceuticals SALSALATE 500 mg/1 0904-1251_701e7e55-b806-485c-b377-fbb5fcd93f81 0904-1251 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20040129 UNAPPROVED DRUG OTHER Major Pharmaceuticals SALSALATE 750 mg/1 0904-1257_fdc21244-229a-47e4-8590-7803a4845c61 0904-1257 HUMAN OTC DRUG Antacid calcium carbonate TABLET, CHEWABLE ORAL 19921030 OTC MONOGRAPH FINAL part331 Major Pharmaceuticals CALCIUM CARBONATE 500 mg/1 0904-1258_14b7f669-5499-4b6c-8aa6-7f8f39da35f9 0904-1258 HUMAN OTC DRUG antacid calcium carbonate TABLET, CHEWABLE ORAL 19920807 OTC MONOGRAPH FINAL part331 Major Pharmaceuticals CALCIUM CARBONATE 500 mg/1 0904-1313_9ce71b9b-524c-4f9e-b5da-4c057b1421a6 0904-1313 HUMAN OTC DRUG Bismatrol Bismuth Subsalicylate LIQUID ORAL 20080530 OTC MONOGRAPH FINAL part335 Major Pharmaceuticals BISMUTH SUBSALICYLATE 262 mg/15mL 0904-1314_24699930-4a45-423e-8a4d-1f23804c2e6e 0904-1314 HUMAN OTC DRUG Bismatrol Bismuth Subsalicylate LIQUID ORAL 20090105 OTC MONOGRAPH FINAL part335 Major Pharmaceuticals BISMUTH SUBSALICYLATE 525 mg/15mL 0904-1315_3fb4129f-1a84-4de8-8d78-439fa9af91f8 0904-1315 HUMAN OTC DRUG Bismatrol Bismuth subsalicylate TABLET, CHEWABLE ORAL 20030103 OTC MONOGRAPH FINAL part335 Major Pharmaceuticals BISMUTH SUBSALICYLATE 262 mg/1 0904-1453_ea8310d0-20be-4d43-806f-1cb4c58c384a 0904-1453 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19980808 ANDA ANDA070027 Major Pharmaceuticals METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 0904-1748_4541ec12-cb80-4b55-9ba5-5d1a3bdd629b 0904-1748 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Major Pharmaceuticals IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-1982_dc6a8c21-78c9-43dd-a289-a727ed8af274 0904-1982 HUMAN OTC DRUG Mapap ACETAMINOPHEN TABLET ORAL 20110421 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 325 mg/1 0904-1983_51f15f14-69e1-42ca-9bca-adcecaab6c32 0904-1983 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN TABLET, FILM COATED ORAL 20110504 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 500 mg/1 0904-1985_fa05c8c2-76ed-476f-8628-343171825270 0904-1985 HUMAN OTC DRUG Childrens MAPAP Acetaminophen Acetaminophen LIQUID ORAL 20120820 OTC MONOGRAPH FINAL part343 Major ACETAMINOPHEN 160 mg/5mL 0904-1987_6a52e7f1-805f-4b05-80a7-bdbad63a475d 0904-1987 HUMAN OTC DRUG MAPAP Extra Strength Acetaminophen CAPSULE ORAL 19971222 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 500 mg/1 0904-1988_1f64151a-b830-4ba5-babd-7f272546cf50 0904-1988 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN TABLET ORAL 20110504 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 500 mg/1 0904-2009_aa02bafc-1043-4f8c-bb09-88b76bf2bb2a 0904-2009 HUMAN OTC DRUG aspirin regular strength regular strength Aspirin TABLET ORAL 20060524 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals ASPIRIN 325 mg/1 0904-2011_d54c9736-fb05-4d11-bf4a-b7ff6367bde6 0904-2011 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals Inc ASPIRIN 325 mg/1 0904-2013_c5ad5f7c-8f63-4453-b66f-b962a0e1f5ed 0904-2013 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals Inc ASPIRIN 325 mg/1 0904-2015_39cb5056-ad67-44cf-a37b-e09f47acda9f 0904-2015 HUMAN OTC DRUG Tri-Buffered Aspirin Aspirin TABLET, FILM COATED ORAL 19900330 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ASPIRIN 325 mg/1 0904-2019_181e1c0c-02ce-40d7-bee0-5aa9c89d3d15 0904-2019 HUMAN OTC DRUG Aspirin Thin coated Aspirin TABLET ORAL 20140507 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals ASPIRIN 325 mg/1 0904-2035_8c0831ef-d9ba-46be-b469-b3793816ebfa 0904-2035 HUMAN OTC DRUG Banophen Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part336 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0904-2051_ea350f66-9133-4fea-b142-4b2ee6462def 0904-2051 HUMAN OTC DRUG Driminate Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 Major Pharmaceuticals DIMENHYDRINATE 50 mg/1 0904-2056_d62a6839-7f4c-4cc9-8403-31f43a243df0 0904-2056 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20090102 OTC MONOGRAPH FINAL part348 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 0904-2151_cf0214ec-ad52-4ea3-bfab-28df6af1c6b2 0904-2151 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20040203 ANDA ANDA086066 Major Pharmaceuticals ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0904-2154_cf0214ec-ad52-4ea3-bfab-28df6af1c6b2 0904-2154 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20040203 ANDA ANDA088088 Major Pharmaceuticals ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0904-2244_0f781141-46a6-4297-952f-cf72110c776d 0904-2244 HUMAN OTC DRUG DOK DOCUSATE SODIUM TABLET, FILM COATED ORAL 20110421 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE SODIUM 100 mg/1 0904-2364_a87623d5-599d-44b1-ae44-b16570649e17 0904-2364 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19760811 ANDA ANDA085159 Major Pharmaceuticals METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0904-2365_a87623d5-599d-44b1-ae44-b16570649e17 0904-2365 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19760818 ANDA ANDA085123 Major Pharmaceuticals METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0904-2500_e8b969b2-4eec-4635-bc74-f2136193e35e 0904-2500 HUMAN OTC DRUG FIBER TABS calcium polycarbophil TABLET ORAL 20100909 OTC MONOGRAPH FINAL part334 Major Pharmaceuticals CALCIUM POLYCARBOPHIL 500 mg/1 0904-2528_d03486cb-f635-4ba0-b0bc-65835862bc16 0904-2528 HUMAN OTC DRUG lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070816 OTC MONOGRAPH FINAL part358G Major Pharmaceuticals PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL 0904-2533_40666d8e-661b-4fac-b084-15fb03519060 0904-2533 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 20130107 OTC MONOGRAPH FINAL part347 Major Pharmaceuticals FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL 0904-2613_d1b20c3b-0168-4929-8b11-af099fc91b45 0904-2613 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 19980803 ANDA ANDA071450 Major Pharmaceuticals ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 0904-2614_d1b20c3b-0168-4929-8b11-af099fc91b45 0904-2614 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20041210 ANDA ANDA071450 Major Pharmaceuticals ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 0904-2666_57a5115d-182a-4bc2-a970-a02abd89bf38 0904-2666 HUMAN OTC DRUG Infant Glycerin Laxative Glycerin SUPPOSITORY RECTAL 20070501 OTC MONOGRAPH FINAL part334 Major Pharmaceuticals GLYCERIN 1.3 g/1 0904-2667_cd049527-3bfc-4c6c-86c0-3f67f68539d1 0904-2667 HUMAN OTC DRUG Adult Glycerin Laxative Glycerin SUPPOSITORY RECTAL 20070501 OTC MONOGRAPH FINAL part334 Major Pharmaceuticals GLYCERIN 1.614 g/1 0904-2674_79c73b09-cff8-4376-9416-a581447f00c1 0904-2674 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 19730618 ANDA ANDA083365 Major Pharmaceuticals HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0904-2720_d944946a-8f93-4f0e-b083-a907a75e5515 0904-2720 HUMAN PRESCRIPTION DRUG K-Vescent Efffervescent Potassium Bicarbonate TABLET, EFFERVESCENT ORAL 20050422 UNAPPROVED DRUG OTHER Major Pharmaceuticals POTASSIUM BICARBONATE 25 meq/1 0904-2725_2fb5fd9a-915c-47be-a224-746c75696ad8 0904-2725 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20090811 ANDA ANDA076899 Major Pharmaceuticals SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 0904-2728_296bc895-21c6-4d94-8e8b-6d1be836d713 0904-2728 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfaccetamide Sodium SOLUTION/ DROPS OPHTHALMIC 20040701 ANDA ANDA040066 Major Pharmaceuticals SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 0904-2821_9e3cd6fc-1a81-4805-b640-6d4ceab0e041 0904-2821 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20040203 ANDA ANDA071655 Major Pharmaceuticals OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0904-2920_789c4620-aed4-4a72-96ff-973054e4e81a 0904-2920 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070995 Major Pharmaceuticals VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0904-2924_789c4620-aed4-4a72-96ff-973054e4e81a 0904-2924 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070994 Major Pharmaceuticals VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0904-2970_733d4939-9647-44fb-ad28-dabd58f0364c 0904-2970 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION/ DROPS OPHTHALMIC 19931129 ANDA ANDA064052 Major Pharmaceuticals TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0904-2992_03f51762-e9ed-4020-a9d0-9938987fa656 0904-2992 HUMAN OTC DRUG OptiClear Tetrahydrozoline HCl SOLUTION/ DROPS OPHTHALMIC 20111007 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 0904-2995_7c50e7f2-1208-4f19-9807-4ab0dd314d3b 0904-2995 HUMAN PRESCRIPTION DRUG Cortomycin Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone OINTMENT OPHTHALMIC 19951030 ANDA ANDA064068 Major Pharmaceuticals BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 10; 3.5; 10000 [USP'U]/g; mg/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0904-3003_821874ba-a22b-4014-900e-f5edad634fc4 0904-3003 HUMAN PRESCRIPTION DRUG Methedex Neomycin and Polymyxin B Sulfates and Dexamethasone SOLUTION/ DROPS OPHTHALMIC 19950913 ANDA ANDA064135 Major Pharmaceuticals DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0904-3006_e1866f0d-e163-4fb5-a988-080ce6179535 0904-3006 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC 19960726 ANDA ANDA040069 Major Pharmaceuticals DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0904-3012_0ea2cee7-197e-405b-a7d4-f470a69a5178 0904-3012 HUMAN PRESCRIPTION DRUG NEOCIDIN Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 19951030 ANDA ANDA064064 Major Pharmaceuticals BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 10000 [USP'U]/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] 0904-3016_b7aa0bae-255b-4792-a963-6606370a175f 0904-3016 HUMAN PRESCRIPTION DRUG Neocidin Neomycin and Polymyxin B Sulfates and Gramicidin SOLUTION/ DROPS OPHTHALMIC 20040607 ANDA ANDA064047 Major Pharmaceuticals GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE .025; 1.75; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 0904-3017_41cfa382-d4ae-43c5-83a5-1ecc635d109b 0904-3017 HUMAN PRESCRIPTION DRUG Cortomycin Neomycin and Polymyxin B Sulfates and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19960828 ANDA ANDA064065 Major Pharmaceuticals HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 0904-3141_559b3666-096b-4a96-9396-3305c552fb1a 0904-3141 HUMAN PRESCRIPTION DRUG Cortomycin Neomycin and Polymyxin B Sulfates and Hydrocortisone SOLUTION/ DROPS OPHTHALMIC 20040601 ANDA ANDA064053 Major Pharmaceuticals HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0904-3365_0e5b53f6-c4a1-4112-93a2-99920c39fb99 0904-3365 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19980721 ANDA ANDA072234 Major Pharmaceuticals BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 0904-3379_e6c1e47f-3d86-4a84-8901-6cde4fce469d 0904-3379 HUMAN PRESCRIPTION DRUG SULINDAC sulindac TABLET ORAL 20090904 ANDA ANDA072051 Major Pharmaceuticals SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-3524_040850b0-68c0-4160-b3a8-271e7ec4cde9 0904-3524 HUMAN PRESCRIPTION DRUG Borofair Acetic Acid in Aqueous Aluminum Acetate SOLUTION/ DROPS AURICULAR (OTIC) 19940225 ANDA ANDA040063 Major Pharmaceuticals ACETIC ACID 2 mg/mL 0904-3535_d2faba43-2088-45c6-8608-dd77cb07596d 0904-3535 HUMAN OTC DRUG enema Saline ENEMA RECTAL 20091209 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 0904-3571_93b29266-3726-425a-9f64-c99601594fab 0904-3571 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 20040216 ANDA ANDA072423 Major Pharmaceuticals MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 0904-3854_bf4bf9c4-4c23-4e96-a0b5-a0c4e65da50e 0904-3854 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET, CHEWABLE ORAL 20100322 ANDA ANDA075712 Major Pharmaceuticals CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0904-3892_86094c4b-064b-475b-b37a-be2fdba03f50 0904-3892 HUMAN PRESCRIPTION DRUG Butalbital Compound Bultabital, Aspirin and Caffeine TABLET ORAL 20000128 ANDA ANDA086162 Major Pharmaceuticals ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 0904-3990_119d5e87-eb2e-48c1-8c5b-500678f3aae3 0904-3990 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20040203 ANDA ANDA071523 Major Pharmaceuticals TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 0904-3991_119d5e87-eb2e-48c1-8c5b-500678f3aae3 0904-3991 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20040203 ANDA ANDA071524 Major Pharmaceuticals TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 0904-4040_ec4d7f14-c319-4d95-9fe2-93f6cd133652 0904-4040 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 20071212 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ASPIRIN 81 mg/1 0904-4062_e083f340-a1d1-4c81-ba7c-e3c0968be3f8 0904-4062 HUMAN OTC DRUG Oral Peroxide carbamide peroxide LIQUID ORAL 20111125 OTC MONOGRAPH NOT FINAL part356 Major Pharmaceuticals CARBAMIDE PEROXIDE .1 mg/mL 0904-4274_66853935-2790-4075-8e95-3a84e253bb38 0904-4274 HUMAN OTC DRUG Sleep Tabs Diphenhydramine HCl TABLET ORAL 19921225 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0904-4277_5c3afc2b-6725-4d45-b543-74ac4073cd25 0904-4277 HUMAN OTC DRUG Isopropyl alcohol Prep Pad isopropyl alcohol SWAB TOPICAL 20010901 OTC MONOGRAPH NOT FINAL part333 Major Pharmaceuticals ISOPROPYL ALCOHOL .7 mL/1 0904-5017_d639b093-9907-4b20-a3a1-c19bfcedb5d7 0904-5017 HUMAN OTC DRUG LiquiTears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20111209 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals POLYVINYL ALCOHOL 14 mg/mL 0904-5018_fca5080f-e23d-40d5-861a-fe53b8d96028 0904-5018 HUMAN OTC DRUG Natural Balance Tears Hypromellose SOLUTION/ DROPS OPHTHALMIC 20111007 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals HYPROMELLOSE 2910 (3 MPA.S) 4 mg/mL 0904-5025_afddffda-5164-4e39-acaa-906fc5c46939 0904-5025 HUMAN PRESCRIPTION DRUG AZO GESIC Phenazopyridine Hydrochloride TABLET ORAL 20110625 UNAPPROVED DRUG OTHER Major Pharmaceuticals PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 0904-5045_6e0e9d22-86cc-4b9a-a67d-ee9c963fec64 0904-5045 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20040216 ANDA ANDA074505 Major Pharmaceuticals CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0904-5046_6e0e9d22-86cc-4b9a-a67d-ee9c963fec64 0904-5046 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20040216 ANDA ANDA074505 Major Pharmaceuticals CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0904-5047_6e0e9d22-86cc-4b9a-a67d-ee9c963fec64 0904-5047 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20040216 ANDA ANDA074505 Major Pharmaceuticals CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0904-5050_1ed4e419-320a-47a0-b4be-43366d798dd0 0904-5050 HUMAN OTC DRUG Pedia Relief Chlorpheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide LIQUID ORAL 19970105 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals, Inc CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 5; 15 mg/5mL; mg/5mL; mg/5mL 0904-5053_f6107863-326d-46b8-987a-9259ba3280d5 0904-5053 HUMAN OTC DRUG SudoGest Pseudoephedrine HCl TABLET ORAL 19810825 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 0904-5058_831a479a-8a4c-46e9-a96d-6989f4fc1d73 0904-5058 HUMAN OTC DRUG Biscolax Laxative Bisacodyl SUPPOSITORY RECTAL 20120824 OTC MONOGRAPH FINAL part334 Major BISACODYL 10 mg/1 0904-5059_55dcc7c5-f1dc-430c-8ada-49ba8ff593a4 0904-5059 HUMAN OTC DRUG Medi-Pads witch hazel SOLUTION RECTAL; TOPICAL 20111025 OTC MONOGRAPH FINAL part346 Major Pharmaceuticals WITCH HAZEL 500 mg/1 0904-5065_5b1af84a-0b9d-45dc-90c0-14324c318360 0904-5065 HUMAN OTC DRUG Robafen AC Guaifenesin and Codeine Phosphate SYRUP ORAL 20021011 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 0904-5068_aac82831-b806-4a59-a81c-c4c3c6e43564 0904-5068 HUMAN OTC DRUG Mi-Acid Gas Relief Simethicone TABLET, CHEWABLE ORAL 20110302 OTC MONOGRAPH FINAL part332 Major Pharmaceuticals DIMETHICONE 80 mg/1 0904-5098_71230489-6c89-4660-b18a-747699ec6e7c 0904-5098 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20030821 OTC MONOGRAPH NOT FINAL part348 Major Pharmaceuticals MENTHOL; ZINC OXIDE 1.5; 10 mg/g; mg/g 0904-5115_c2910f8d-6036-4893-b1e2-337d7ead85cb 0904-5115 HUMAN OTC DRUG Mi Acid Calcium carbonate, Magnesium hydroxide TABLET, CHEWABLE ORAL 20030103 OTC MONOGRAPH FINAL part331 Major Pharmaceuticals CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 700; 300 mg/1; mg/1 0904-5116_c72fbd57-95a8-48ba-9eab-7c084bca3817 0904-5116 HUMAN OTC DRUG mapap childrens Acetaminophen SUSPENSION ORAL 19960206 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 160 mg/5mL 0904-5125_66020be2-be27-419d-883e-1b478103076f 0904-5125 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 19941001 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 0904-5135_5079789d-dc92-4b34-a268-6b6bc4e75284 0904-5135 HUMAN OTC DRUG Pain Reliever Plus Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 0904-5154_e88d03b6-87e5-48f3-81f0-9b0f84d9ae4e 0904-5154 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET ORAL 20091005 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals GUAIFENESIN 200 mg/1 0904-5165_f36bec2a-c4e8-4eed-984e-2caf8ae59faa 0904-5165 HUMAN OTC DRUG Senna-Lax SENNOSIDES A AND B TABLET, FILM COATED ORAL 20110504 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals SENNOSIDES A AND B 8.6 mg/1 0904-5168_a9f844af-6887-4496-8c64-721357a4a5bb 0904-5168 HUMAN OTC DRUG LubriFresh P.M. white petrolatum mineral oil OINTMENT OPHTHALMIC 20111209 OTC MONOGRAPH FINAL part349 Major Pharaceuticals MINERAL OIL; PETROLATUM 150; 830 mg/g; mg/g 0904-5174_49e8514f-2c08-413a-b9eb-cf6eed00575a 0904-5174 HUMAN OTC DRUG Banophen diphenhydramine hydrochloride LIQUID ORAL 20120824 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 0904-5180_40e73c6b-ab7c-4760-875c-39375c903698 0904-5180 HUMAN OTC DRUG Tussin Sugar Free Cough Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20090107 OTC MONOGRAPH FINAL part341 Major Pharmeceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 0904-5180_ea84c358-0750-463b-8b5c-75adde806b24 0904-5180 HUMAN OTC DRUG Tussin Sugar Free Cough Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20090107 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 0904-5186_4541ec12-cb80-4b55-9ba5-5d1a3bdd629b 0904-5186 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Major Pharmaceuticals IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-5187_4541ec12-cb80-4b55-9ba5-5d1a3bdd629b 0904-5187 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Major Pharmaceuticals IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-5199_5cdd68b5-8358-44af-ac88-e559fc87fb84 0904-5199 HUMAN OTC DRUG Natural Fiber Therapy Natural Laxative Natural Laxative Psyllium Husk POWDER, FOR SOLUTION ORAL 20110802 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals PSYLLIUM HUSK 3.4 g/7g 0904-5200_29178851-e96c-4c79-8d62-97a4f8de3a1b 0904-5200 HUMAN OTC DRUG Natural Fiber Therapy Natural Laxative Psyllium Husk POWDER, FOR SOLUTION ORAL 20110802 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals PSYLLIUM HUSK 3.4 g/7g 0904-5222_0e5b53f6-c4a1-4112-93a2-99920c39fb99 0904-5222 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19980721 ANDA ANDA072235 Major Pharmaceuticals BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 0904-5229_019a655e-0256-4de4-b587-50f463e812b9 0904-5229 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET ORAL 19970109 ANDA ANDA074661 Major Pharmaceuticals NAPROXEN SODIUM 220 mg/1 0904-5230_495e86b9-ddd5-42b2-a335-0154fd461b6b 0904-5230 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET, FILM COATED ORAL 19970109 ANDA ANDA074661 Major Pharmaceuticals NAPROXEN SODIUM 220 mg/1 0904-5255_fa9f94f4-f36a-48b7-b5bb-e811992a9e64 0904-5255 HUMAN OTC DRUG mapap infants concentrated Acetaminophen SUSPENSION/ DROPS ORAL 19900915 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 80 mg/.8mL 0904-5256_34dfdf96-656d-43d6-b223-c213473b2dc9 0904-5256 HUMAN OTC DRUG Childrens Chewable Mapap Acetaminophen TABLET, CHEWABLE ORAL 20110504 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 80 mg/1 0904-5259_87106483-2d4b-4d98-b080-2840a1934eca 0904-5259 HUMAN OTC DRUG Major Thera-Gel Therapeutic Anti-Dandruff Coal Tar SHAMPOO TOPICAL 20070901 OTC MONOGRAPH FINAL part358H Major Pharmaceuticals COAL TAR .5 mL/100mL 0904-5282_fb49414c-8afe-4996-8d9d-fbf98f348a82 0904-5282 HUMAN PRESCRIPTION DRUG RIFAMPIN RIFAMPIN CAPSULE ORAL; ORAL 20091007 ANDA ANDA064150 Major Pharmaceuticals RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 0904-5304_9aee4d17-7248-4dcf-b797-c3080530f139 0904-5304 HUMAN OTC DRUG Major Prep Hemorrhoidal hard fat, phenylephrine HCl SUPPOSITORY RECTAL 20080328 OTC MONOGRAPH FINAL part346 Major Pharmaceuticals FAT, HARD; PHENYLEPHRINE HYDROCHLORIDE 2; 74 g/2.5g; mg/2.5g 0904-5306_d62a6839-7f4c-4cc9-8403-31f43a243df0 0904-5306 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20090102 OTC MONOGRAPH FINAL part348 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0904-5307_7e15eb97-8c1f-4260-a2dc-eb1840f20d16 0904-5307 HUMAN OTC DRUG Banophen Diphenhydramine HCl CAPSULE ORAL 20091102 OTC MONOGRAPH FINAL part336 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 0904-5309_6917c1d8-3e62-4f3b-8ecb-f17b70fa4708 0904-5309 HUMAN OTC DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 19990207 ANDA ANDA074937 Major Pharmaceuticals IBUPROFEN 100 mg/5mL 0904-5314_03f42d2a-cedc-4913-bced-3766cbf176e1 0904-5314 HUMAN OTC DRUG Sodium Chloride Hypertonicity sodium chloride SOLUTION OPHTHALMIC 20110101 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals SODIUM CHLORIDE 50 mg/mL 0904-5315_09891c58-857b-4041-8033-46675e6ea9db 0904-5315 HUMAN OTC DRUG Sodium Chloride Hypertonicity sodium chloride OINTMENT OPHTHALMIC 20110101 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals SODIUM CHLORIDE 50 mg/g 0904-5323_79df0ed9-4186-414c-9af7-e57a2535c466 0904-5323 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 19980617 20150531 ANDA ANDA072096 Major Pharmaceuticals IBUPROFEN 200 mg/1 0904-5339_6081446a-cf1c-4e34-8f0c-316d1c2aa434 0904-5339 HUMAN PRESCRIPTION DRUG PRENATAL PLUS IRON MULTIVITAMIN/MULTIMINERAL SUPPLEMENT TABLET, FILM COATED ORAL 20110607 UNAPPROVED DRUG OTHER Major Pharmaceuticals .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FOLIC ACID; IRON PENTACARBONYL; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE 22; 920; 120; 200; 400; 2; 12; 1; 29; 20; 10; 3; 1.84; 3080; 25 [iU]/1; [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 0904-5351_2d7f017c-40a5-457d-84e6-550449aef77a 0904-5351 HUMAN OTC DRUG SudoGest Chlorpheniramine maleate pseudoephedrine HCl TABLET ORAL 19921216 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 60 mg/1; mg/1 0904-5354_9758d886-bd58-4eb2-a827-fa8e7fee2b7c 0904-5354 HUMAN OTC DRUG Banophen Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part348 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 0904-5365_4498104a-e41d-41d9-9aed-01904d91af87 0904-5365 HUMAN OTC DRUG Acid Gone Antacid Extra Strength aluminum hydroxide and magnesium carbonate TABLET, CHEWABLE ORAL 20140606 OTC MONOGRAPH FINAL part331 Major Pharmaceuticals ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 0904-5367_5dedd1c0-41ee-4e2f-a243-71063904880a 0904-5367 HUMAN OTC DRUG SudoGest Pseudoephedrine hydrochloride LIQUID ORAL 20010105 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals, Inc PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg/5mL 0904-5377_2c3a31d8-e6ca-4a68-86e9-25993cd934ad 0904-5377 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20100831 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals WATER 99.05 mL/100mL 0904-5379_5a38bee3-1e33-4979-8ae4-ef02f52f9954 0904-5379 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20040206 ANDA ANDA075034 Major Pharmaceuticals GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0904-5392_351c3d1e-1111-43e8-ad7d-a7e0a7b6912e 0904-5392 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100928 ANDA ANDA074052 Major Pharmaceuticals ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-5415_ec2b3bd0-142f-4c48-97d2-6f43fb31862d 0904-5415 HUMAN OTC DRUG Miconazole 3 Combination Pack miconazole nitrate KIT VAGINAL 20021202 ANDA ANDA074926 Major Pharmaceuticals 0904-5448_17115058-a053-4a13-9cf1-444b35279542 0904-5448 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 20040216 ANDA ANDA075191 Major Pharmaceuticals PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 0904-5458_5c251b09-f330-4c6e-ad8f-0322912be09a 0904-5458 HUMAN OTC DRUG MAJOR Extra Strength Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 19980916 OTC MONOGRAPH FINAL part332 Major Pharmaceuticals DIMETHICONE 125 mg/1 0904-5463_b4962985-47e6-4389-874f-76742b086e2f 0904-5463 HUMAN OTC DRUG ibuprofen ibuprofen SUSPENSION ORAL 20000108 ANDA ANDA075217 Major Pharmaceuticals IBUPROFEN 50 mg/1.25mL 0904-5464_b9a73f2e-4c8d-4a4c-a828-716e377f5a78 0904-5464 HUMAN OTC DRUG Major Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20000201 ANDA ANDA074937 Major Pharmaceuticals IBUPROFEN 100 mg/5mL 0904-5495_7ed1f92c-577a-4354-8b59-8b97e09299d3 0904-5495 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal System Nitroglycerin PATCH TRANSDERMAL 19981030 ANDA ANDA089884 Harvard Drug Group, LLC NITROGLYCERIN .2 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0904-5496_7ed1f92c-577a-4354-8b59-8b97e09299d3 0904-5496 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal System Nitroglycerin PATCH TRANSDERMAL 19981030 ANDA ANDA089885 Harvard Drug Group, LLC NITROGLYCERIN .4 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0904-5497_7ed1f92c-577a-4354-8b59-8b97e09299d3 0904-5497 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal System Nitroglycerin PATCH TRANSDERMAL 19981030 ANDA ANDA089886 Harvard Drug Group, LLC NITROGLYCERIN .6 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0904-5502_d38b0181-6600-48d7-bb51-70e0075306d2 0904-5502 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20040203 ANDA ANDA075483 Major Pharmaceuticals ENALAPRIL MALEATE 5 mg/1 0904-5512_a68f4aa3-d072-49f2-9782-c41d116e8323 0904-5512 HUMAN OTC DRUG Senna/Docusate Sodium Docusate sodium and Sennosides TABLET, FILM COATED ORAL 20110616 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 0904-5513_ca7b6e6c-c860-452e-b2f1-1bf3254dc224 0904-5513 HUMAN OTC DRUG antacid Calcium carbonate TABLET, CHEWABLE ORAL 20010320 OTC MONOGRAPH FINAL part331 Major Pharmaceuticals CALCIUM CARBONATE 750 mg/1 0904-5522_1ae60f13-0f23-4ef0-863d-a10f728a6f92 0904-5522 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Major Pharmaceuticals DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0904-5523_1ae60f13-0f23-4ef0-863d-a10f728a6f92 0904-5523 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Major Pharmaceuticals DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0904-5524_1ae60f13-0f23-4ef0-863d-a10f728a6f92 0904-5524 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Major Pharmaceuticals DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0904-5525_1ae60f13-0f23-4ef0-863d-a10f728a6f92 0904-5525 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Major Pharmaceuticals DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0904-5529_5f5734ab-5010-48d3-85c2-87e374f24079 0904-5529 HUMAN OTC DRUG heartburn relief original strength Famotidine TABLET ORAL 20090909 ANDA ANDA075400 Major Pharmaceuticals FAMOTIDINE 10 mg/1 0904-5532_2a833106-8cc2-4975-8642-fc856b0bcb5e 0904-5532 HUMAN OTC DRUG Cromolyn Sodium Cromolyn Sodium SPRAY, METERED NASAL 20010703 ANDA ANDA075702 Major Pharmaceuticals CROMOLYN SODIUM 5.2 mg/mL 0904-5535_208389e6-ebbc-4e23-8312-e68bb6f697f0 0904-5535 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20081108 ANDA ANDA074410 Major Pharmaceuticals NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-5536_208389e6-ebbc-4e23-8312-e68bb6f697f0 0904-5536 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20081108 ANDA ANDA074410 Major Pharmaceuticals NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-5537_208389e6-ebbc-4e23-8312-e68bb6f697f0 0904-5537 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20091120 ANDA ANDA074410 Major Pharmaceuticals NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-5551_ca42b961-2166-4bed-9c52-8d1d57791ba4 0904-5551 HUMAN OTC DRUG Banophen Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 0904-5553_c6d5b9f7-9528-4343-97ae-05410097f85e 0904-5553 HUMAN PRESCRIPTION DRUG FAMOTIDINE FAMOTIDINE TABLET, FILM COATED ORAL 20090610 ANDA ANDA075718 Major Pharmaceuticals FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0904-5554_c6d5b9f7-9528-4343-97ae-05410097f85e 0904-5554 HUMAN PRESCRIPTION DRUG FAMOTIDINE FAMOTIDINE TABLET, FILM COATED ORAL 20090610 ANDA ANDA075718 Major Pharmaceuticals FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0904-5559_b15567de-9333-48b3-b609-b192be068925 0904-5559 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20050407 ANDA ANDA084903 Major Pharmaceuticals PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0904-5572_63cc3de3-12bd-429e-8acf-39200110f948 0904-5572 HUMAN OTC DRUG MAJOR ULTRA STRENGTH GAS RELIEF Simethicone CAPSULE, LIQUID FILLED ORAL 20100712 OTC MONOGRAPH FINAL part332 Major Pharmaceuticals DIMETHICONE 180 mg/1 0904-5577_9ba1104d-e26a-43d7-9824-6e22f88e803d 0904-5577 HUMAN OTC DRUG Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20020403 ANDA ANDA074937 Major Pharmaceuticals IBUPROFEN 100 mg/5mL 0904-5590_208389e6-ebbc-4e23-8312-e68bb6f697f0 0904-5590 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040401 ANDA ANDA076494 Major Pharmaceuticals NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-5591_208389e6-ebbc-4e23-8312-e68bb6f697f0 0904-5591 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040401 ANDA ANDA076494 Major Pharmaceuticals NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-5609_d38b0181-6600-48d7-bb51-70e0075306d2 0904-5609 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20040203 ANDA ANDA075483 Major Pharmaceuticals ENALAPRIL MALEATE 2.5 mg/1 0904-5610_d38b0181-6600-48d7-bb51-70e0075306d2 0904-5610 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20040203 ANDA ANDA075483 Major Pharmaceuticals ENALAPRIL MALEATE 10 mg/1 0904-5611_d38b0181-6600-48d7-bb51-70e0075306d2 0904-5611 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20040203 ANDA ANDA075483 Major Pharmaceuticals ENALAPRIL MALEATE 20 mg/1 0904-5631_4a3ffd32-ee41-4a05-b1c6-6eabda92cda3 0904-5631 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Major Pharmaceuticals GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0904-5632_4a3ffd32-ee41-4a05-b1c6-6eabda92cda3 0904-5632 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Major Pharmaceuticals GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0904-5633_4a3ffd32-ee41-4a05-b1c6-6eabda92cda3 0904-5633 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Major Pharmaceuticals GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0904-5643_7275fc4d-3dc4-4507-acd7-4eb35f339d66 0904-5643 HUMAN OTC DRUG Senna/Docusate Sodium Docusate sodium and Sennosides TABLET, FILM COATED ORAL 20100928 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 0904-5656_7778efe7-bbca-4246-aa67-01f0b8c6ab14 0904-5656 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20061120 ANDA ANDA070974 Major Pharmaceuticals CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0904-5657_7778efe7-bbca-4246-aa67-01f0b8c6ab14 0904-5657 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20061120 ANDA ANDA070975 Major Pharmaceuticals CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0904-5658_7778efe7-bbca-4246-aa67-01f0b8c6ab14 0904-5658 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20061120 ANDA ANDA070976 Major Pharmaceuticals CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0904-5666_80110b85-6709-44b9-95c0-ba82f0e82871 0904-5666 HUMAN OTC DRUG phosphate dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20100602 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 2.9; 7.2 g/15mL; g/15mL 0904-5675_4c187a13-b71e-4735-ac17-c62f8c9a2f8c 0904-5675 HUMAN OTC DRUG FIBER THERAPY methylcellulose POWDER, FOR SOLUTION ORAL 20080418 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals METHYLCELLULOSE (4000 MPA.S) 2 g/19g 0904-5676_27b5cfb7-b039-4d1b-9bbd-6fe480804c83 0904-5676 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20040214 ANDA ANDA075356 Major Pharmaceuticals PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-5677_27b5cfb7-b039-4d1b-9bbd-6fe480804c83 0904-5677 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20040214 ANDA ANDA075356 Major Pharmaceuticals PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-5678_27b5cfb7-b039-4d1b-9bbd-6fe480804c83 0904-5678 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20040214 ANDA ANDA075356 Major Pharmaceuticals PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-5679_27b5cfb7-b039-4d1b-9bbd-6fe480804c83 0904-5679 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20040214 ANDA ANDA075356 Major Pharmaceuticals PAROXETINE HYDROCHLORIDE ANHYDROUS 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-5684_5d6241b1-7c48-4b30-88e8-c33b1333c156 0904-5684 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20080228 ANDA ANDA076048 Major Pharmaceuticals OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0904-5694_7d87e7c1-dd7e-4ad7-b734-4c180cb1811b 0904-5694 HUMAN OTC DRUG Major Extra Strength Cold and Hot Pain Relief Therapy Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Major Pharmaceuticals MENTHOL 750 mg/1 0904-5709_f45cb097-f6f9-4a76-812c-e09a6cc01b90 0904-5709 HUMAN OTC DRUG KAO-TIN PEPPERMINT FLAVOR bismuth subsalicylate LIQUID ORAL 20110214 OTC MONOGRAPH FINAL part335 MAJOR Pharmaceuticals Inc. BISMUTH SUBSALICYLATE 262 mg/15mL 0904-5711_3115ce25-2134-42fe-8d38-f2d57a31f5e0 0904-5711 HUMAN OTC DRUG Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20090317 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals OXYMETAZOLINE HYDROCHLORIDE 5 g/100mL 0904-5721_991a0bb2-ca05-45cd-b3fd-71a6638b5f73 0904-5721 HUMAN OTC DRUG MINTOX aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part331 MAJOR Pharmaceuticals Inc. ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 0904-5725_6de63963-24bb-4e60-80ff-bce734566374 0904-5725 HUMAN OTC DRUG MINTOX MAXIMUM STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part331 MAJOR Pharmaceuticals Inc. ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 0904-5728_4ec9a064-2d81-4f8a-a521-daf56331d49c 0904-5728 HUMAN OTC DRUG allergy Loratadine TABLET ORAL 20050221 ANDA ANDA076301 Major Pharmaceuticals LORATADINE 10 mg/1 0904-5731_09817cee-c6e4-406c-939b-6585a194ea85 0904-5731 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 20070711 OTC MONOGRAPH FINAL part347 Major PETROLATUM 1 g/g 0904-5733_922586e3-9155-40a1-92f4-ae80e75f1f72 0904-5733 HUMAN OTC DRUG Sudogest PE Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 0904-5734_0f93786a-e464-4d6c-9735-1e91d113ea76 0904-5734 HUMAN OTC DRUG nicorelief Nicotine Polacrilex GUM, CHEWING ORAL 20050412 ANDA ANDA076775 Major Pharmaceuticals NICOTINE 2 mg/1 0904-5735_212de1bc-c3e4-434e-b2ed-9df1dd69d9b4 0904-5735 HUMAN OTC DRUG nicorelief Nicotine Polacrilex GUM, CHEWING ORAL 20050412 ANDA ANDA076789 Major Pharmaceuticals NICOTINE 4 mg/1 0904-5736_26730824-7fe0-493c-8c1f-c2c45d31e7c5 0904-5736 HUMAN OTC DRUG Nicorelief Nicotine Polacrilex GUM, CHEWING ORAL 20050412 ANDA ANDA078325 Major Pharmaceuticals NICOTINE 2 mg/1 0904-5737_7fe63529-8d09-4c2a-a913-cdee5622f663 0904-5737 HUMAN OTC DRUG Nicorelief Nicotine Polacrilex GUM, CHEWING ORAL 20050412 ANDA ANDA078326 Major Pharmaceuticals NICOTINE 4 mg/1 0904-5751_54cb9b3b-0e9f-4b86-8a81-2c113b61281c 0904-5751 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050203 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 80 mg/1 0904-5752_e2e63fcf-0b07-45b0-852a-e082c07c7d89 0904-5752 HUMAN OTC DRUG Robafen Cough Dextromethorphan HBr CAPSULE ORAL 20060424 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 0904-5754_d86787e8-b740-41c2-8027-2976fab3a2ac 0904-5754 HUMAN OTC DRUG Junior Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 160 mg/1 0904-5758_513d42db-a169-4404-908c-d04c498fe84a 0904-5758 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20051222 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals GUAIFENESIN 400 mg/1 0904-5763_f3ddec84-8e55-4918-bf79-300c17bf0bdb 0904-5763 HUMAN OTC DRUG Day Time Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20110325 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 0904-5764_58c2fc45-cb2b-4d6a-85f7-b493f731174d 0904-5764 HUMAN OTC DRUG Major Night Time Multi Symptom cold and flu relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20120301 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 0904-5769_d94b2901-7206-4be4-b622-d45e2656f06a 0904-5769 HUMAN OTC DRUG mapap arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060216 ANDA ANDA075077 Major Pharmaceuticals ACETAMINOPHEN 650 mg/1 0904-5770_f1fcc41c-e16f-448c-be0e-b1d9586d56fd 0904-5770 HUMAN OTC DRUG Tussin CF DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20090107 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 0904-5776_a8daaf23-b16f-4801-be69-63ab71b86abd 0904-5776 HUMAN OTC DRUG All-Nite Cold and Flu acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090218 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 0904-5777_109dbef7-84b1-4be2-8d7e-c9ba4f6871ed 0904-5777 HUMAN OTC DRUG All-Nite Cold and Flu acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090218 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 0904-5779_33449f96-aa53-43d6-a772-33fe0af04601 0904-5779 HUMAN OTC DRUG KAO- TIN DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20111201 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE CALCIUM 240 mg/1 0904-5780_43afd289-724a-4c81-8a08-3bca517b956c 0904-5780 HUMAN OTC DRUG Major Heartburn Relief Maximum Strength Famotidine TABLET ORAL 20060929 ANDA ANDA077351 Major Pharmaceuticals FAMOTIDINE 20 mg/1 0904-5781_71c45891-4c6c-4c27-ab75-18e4e5f0308d 0904-5781 HUMAN OTC DRUG DIBROMM with PE BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20090107 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 0904-5782_96182b09-1204-4497-bd3d-696f73e8646c 0904-5782 HUMAN OTC DRUG DIBROMM DM BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20091107 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 0904-5783_43900b7e-ee73-4ed1-b568-7be9eb93d8cf 0904-5783 HUMAN OTC DRUG Mapap Sinus Acetaminophen, Phenylephrine HCl TABLET ORAL 20050726 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 0904-5784_be0b6ea1-ff43-4afe-9b59-fb2c083452e4 0904-5784 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20070216 ANDA ANDA076001 Major Pharmaceuticals FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-5785_be0b6ea1-ff43-4afe-9b59-fb2c083452e4 0904-5785 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20070216 ANDA ANDA076001 Major Pharmaceuticals FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-5786_bd59f7c5-b7a2-4037-9828-412d44e85341 0904-5786 HUMAN OTC DRUG Multi-Symptom Mapap Cold Formula Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050715 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 0904-5788_1d1689cb-baa1-4e59-ab72-c25a6c8d1549 0904-5788 HUMAN OTC DRUG Natural Fiber Therapy Natural Laxative Natural Laxative Psyllium Husk POWDER, FOR SOLUTION ORAL 20110802 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals PSYLLIUM HUSK 3.4 g/7g 0904-5789_98a6f5a9-89c3-4ca1-a9d2-e258aacc0c12 0904-5789 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20070419 ANDA ANDA075677 Major Pharmaceuticals ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0904-5790_974d7938-7ebf-45ed-9e24-06660e7315d1 0904-5790 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20070209 ANDA ANDA077309 Major Pharmaceuticals ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0904-5791_e403b309-e697-4b37-bc25-d356faad60ba 0904-5791 HUMAN OTC DRUG Childrens Mapap Acetaminophen TABLET, CHEWABLE ORAL 20041206 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 80 mg/1 0904-5792_eeac4f98-d2e1-4bfd-bfc5-619066bd7490 0904-5792 HUMAN OTC DRUG Sinus Congestion PE Guaifenesin and Phenylephrine HCl TABLET ORAL 20060415 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 0904-5794_3d5a986e-cd84-43ef-bc7d-ddf5d70820b4 0904-5794 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Extended Release metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20090610 ANDA ANDA076706 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0904-5795_3d5a986e-cd84-43ef-bc7d-ddf5d70820b4 0904-5795 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Extended Release metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20090610 ANDA ANDA076706 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0904-5796_202565ec-b2b4-4b05-8b72-fae77a3734d7 0904-5796 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20080326 NDA NDA018569 Major Pharmaceuticals FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0904-5797_202565ec-b2b4-4b05-8b72-fae77a3734d7 0904-5797 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20080326 NDA NDA018569 Major Pharmaceuticals FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0904-5798_202565ec-b2b4-4b05-8b72-fae77a3734d7 0904-5798 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20080326 NDA NDA018569 Major Pharmaceuticals FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 0904-5800_03e4e6a6-0924-4fc5-ada3-86d73f228cf1 0904-5800 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Major Pharmaceuticals SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0904-5801_03e4e6a6-0924-4fc5-ada3-86d73f228cf1 0904-5801 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Major Pharmaceuticals SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0904-5802_03e4e6a6-0924-4fc5-ada3-86d73f228cf1 0904-5802 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Major Pharmaceuticals SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0904-5803_aa0c7100-9352-4990-9bd6-57bef533c1c7 0904-5803 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Major Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 0904-5806_d634e4e1-7b35-4f89-96ac-97d74cd36b0e 0904-5806 HUMAN OTC DRUG Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Major Pharmaceuticals LORATADINE 10 mg/1 0904-5808_19aeb7bc-c96b-47b7-aece-8d5333091b24 0904-5808 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Major Pharmaceuticals LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0904-5809_19aeb7bc-c96b-47b7-aece-8d5333091b24 0904-5809 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Major Pharmaceuticals LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0904-5810_19aeb7bc-c96b-47b7-aece-8d5333091b24 0904-5810 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Major Pharmaceuticals LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0904-5811_19aeb7bc-c96b-47b7-aece-8d5333091b24 0904-5811 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Major Pharmaceuticals LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 0904-5816_4878a197-28ca-4adc-abc8-962c57eed08d 0904-5816 HUMAN OTC DRUG Extra Strength Mapap Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 500 mg/1 0904-5817_4df6375a-3f26-446d-b1b0-fe94ff51b5b9 0904-5817 HUMAN OTC DRUG Cough and Cold Chlorpheniramine maleate TABLET ORAL 20030503 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 0904-5818_4267f4a8-98f6-41ed-813b-34327030f2f5 0904-5818 HUMAN OTC DRUG Ranitidine 75 Ranitidine TABLET ORAL 20090526 ANDA ANDA076760 Major Pharmaceuticals RANITIDINE HYDROCHLORIDE 75 mg/1 0904-5828_64bc8268-35a7-483a-b0ec-42e7baa5986b 0904-5828 HUMAN OTC DRUG childrens all day allergy cetirizine hydrochloride LIQUID ORAL 20100726 ANDA ANDA090254 Major Pharmaceuticals CETIRIZINE HYDROCHLORIDE 5 mg/5mL 0904-5831_7a4ac903-0cb0-446f-8506-baf7eef16093 0904-5831 HUMAN OTC DRUG All day Allergy d Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080506 ANDA ANDA077170 Major Pharmaceuticals CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 0904-5832_f50650f9-fce0-464f-b537-178dd2f68f59 0904-5832 HUMAN OTC DRUG Major Ranitidine Maximum Strength Ranitidine TABLET ORAL 20080218 ANDA ANDA078653 Major Pharmaceuticals RANITIDINE HYDROCHLORIDE 150 mg/1 0904-5833_af1334c2-c43b-4928-ba05-6a1f3def529e 0904-5833 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Major Pharmaceuticals LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 0904-5834_1432477b-bc2f-485a-86b2-9fff296f57c8 0904-5834 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080229 NDA NDA022032 Major Pharmaceuticals OMEPRAZOLE 20 mg/1 0904-5836_fa0aeecc-6363-4567-96c7-1c76cbbe6b30 0904-5836 HUMAN OTC DRUG Alcohol Prep Pad with Benzocaine benzocaine SWAB TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part348 Major Pharmaceuticals BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 0904-5837_d6968a02-1826-4a72-92df-4a7176e0247b 0904-5837 HUMAN OTC DRUG Itchy Eye Ketotifen SOLUTION OPHTHALMIC 20101116 ANDA ANDA077958 Major Pharmaceuticals KETOTIFEN FUMARATE .25 mg/mL 0904-5840_9c535488-a878-4ffd-aca4-49c461ccaea8 0904-5840 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20080509 ANDA ANDA040712 Major Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0904-5843_1874b9fb-ea3f-4444-a4b7-b20366a2a97a 0904-5843 HUMAN OTC DRUG Major Vitamin A and D Skin Protectant Petrolatum and Lanolin OINTMENT TOPICAL 20070901 OTC MONOGRAPH FINAL part347 Major Pharmaceuticals LANOLIN; PETROLATUM 15.5; 53.4 mL/100g; mL/100g 0904-5847_bca5e382-b8d6-4447-b522-c247f85ba709 0904-5847 HUMAN OTC DRUG Extra Strength Acetaminohpen Adult Rapid Burst Cherry Acetaminophen LIQUID ORAL 20090702 OTC MONOGRAPH FINAL part341 Major Pharmeceuticals ACETAMINOPHEN 500 mg/5mL 0904-5849_f633cec7-1625-47b5-8729-e8aa80ac1756 0904-5849 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0904-5850_f633cec7-1625-47b5-8729-e8aa80ac1756 0904-5850 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0904-5851_f633cec7-1625-47b5-8729-e8aa80ac1756 0904-5851 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0904-5852_8c2da9c6-7411-4f58-a932-9c300ed53c43 0904-5852 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20071227 ANDA ANDA078317 Major Pharmaceuticals CETIRIZINE HYDROCHLORIDE 10 mg/1 0904-5853_125ad425-dc63-4143-aa05-bf67793a0888 0904-5853 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Major Pharmaceuticals IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-5854_125ad425-dc63-4143-aa05-bf67793a0888 0904-5854 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Major Pharmaceuticals IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-5855_125ad425-dc63-4143-aa05-bf67793a0888 0904-5855 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Major Pharmaceuticals IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-5857_a1631071-3e88-44d8-b74f-56a4821062ee 0904-5857 HUMAN OTC DRUG Analgesic Creme Rub Trolamine Salicylate 10% CREAM TOPICAL 20140510 OTC MONOGRAPH NOT FINAL part348 Major Pharmaceuticals TROLAMINE SALICYLATE 100 mg/g 0904-5858_fc4d44b6-280d-43d7-ad9d-ca8f8e640fe8 0904-5858 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080402 ANDA ANDA074342 Major Pharmaceuticals ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0904-5859_fc4d44b6-280d-43d7-ad9d-ca8f8e640fe8 0904-5859 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080402 ANDA ANDA074342 Major Pharmaceuticals ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0904-5860_fc4d44b6-280d-43d7-ad9d-ca8f8e640fe8 0904-5860 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080402 ANDA ANDA074342 Major Pharmaceuticals ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0904-5861_fc4d44b6-280d-43d7-ad9d-ca8f8e640fe8 0904-5861 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080402 ANDA ANDA074342 Major Pharmaceuticals ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0904-5869_8ac06691-0ba1-4286-97b1-fc0978b51601 0904-5869 HUMAN OTC DRUG DOK DOCUSATE SODIUM TABLET, FILM COATED ORAL 20110421 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE SODIUM 100 mg/1 0904-5874_42f15aa9-89e7-48b6-bbc8-2582a2508a56 0904-5874 HUMAN OTC DRUG Childrens Plus Cough and Runny Nose ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE SUSPENSION ORAL 20090107 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL 0904-5875_83382ea7-cd6d-49db-b0a0-707df224ca3d 0904-5875 HUMAN OTC DRUG Cough Relief Orange DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20090701 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 0904-5877_e9da9eab-a7ef-4cc6-9236-57b29637b06d 0904-5877 HUMAN OTC DRUG ibuprofen pm diphenhydramine citrate and ibuprofen TABLET, COATED ORAL 20090218 ANDA ANDA079113 Major Pharmaceuticals DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 0904-5879_924ccf88-24b4-47d1-8b90-9bd7be3ac917 0904-5879 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20080214 ANDA ANDA078692 Major Pharmaceuticals CETIRIZINE HYDROCHLORIDE 10 mg/1 0904-5880_623ae57a-d3cd-4d01-9da9-bb9b5479c362 0904-5880 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20080605 ANDA ANDA071135 Major Pharmaceuticals DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0904-5881_623ae57a-d3cd-4d01-9da9-bb9b5479c362 0904-5881 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20080605 20151008 ANDA ANDA071136 Major Pharmaceuticals DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0904-5887_713c8681-71cd-4ac8-b94d-9ef33ca0378a 0904-5887 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20081113 ANDA ANDA089807 Major Pharmaceuticals THEOPHYLLINE ANHYDROUS 100 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0904-5888_713c8681-71cd-4ac8-b94d-9ef33ca0378a 0904-5888 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20081113 ANDA ANDA089808 Major Pharmaceuticals THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0904-5889_713c8681-71cd-4ac8-b94d-9ef33ca0378a 0904-5889 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20081113 ANDA ANDA089763 Major Pharmaceuticals THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 0904-5891_c5625a65-0600-42a1-b392-46c58c14e4b0 0904-5891 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20080801 ANDA ANDA076341 Major Pharmaceuticals PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0904-5892_c5625a65-0600-42a1-b392-46c58c14e4b0 0904-5892 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20080801 ANDA ANDA076341 Major Pharmaceuticals PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0904-5893_c5625a65-0600-42a1-b392-46c58c14e4b0 0904-5893 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20080801 ANDA ANDA076341 Major Pharmaceuticals PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0904-5894_57565059-8150-4537-88b6-bb8758ab49a0 0904-5894 HUMAN OTC DRUG INFANTS GAS RELIEF Simethicone SUSPENSION/ DROPS ORAL 20101207 OTC MONOGRAPH FINAL part332 MAJOR Pharmaceuticals Inc. DIMETHICONE 20 mg/.3mL 0904-5895_750ef689-0ca2-495c-bc13-c3686a33e123 0904-5895 HUMAN OTC DRUG enema mineral oil Mineral Oil LIQUID RECTAL 19901215 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals MINERAL OIL 100 mL/100mL 0904-5901_6004116e-5206-4c1a-95de-26ac118d9af6 0904-5901 HUMAN OTC DRUG INFANTS MAPAP Pain Reliever /Fever Reducer Acetaminophen SOLUTION/ DROPS ORAL 20120824 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 80 mg/.8mL 0904-5904_a9c19d0e-4ea4-4fb4-a060-b41e4c614af3 0904-5904 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 MAJOR PHARMACEUTICALS INC BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 0904-5905_a9c19d0e-4ea4-4fb4-a060-b41e4c614af3 0904-5905 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 MAJOR PHARMACEUTICALS INC BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 0904-5921_07b29251-8d93-4ea2-8545-7b9063e97ce2 0904-5921 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20090610 ANDA ANDA077002 Major Pharmaceuticals DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0904-5922_07b29251-8d93-4ea2-8545-7b9063e97ce2 0904-5922 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20090610 ANDA ANDA077002 Major Pharmaceuticals DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 0904-5923_a2de6f88-0bdc-442a-8027-112700271cf3 0904-5923 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20090219 ANDA ANDA071207 Major Pharmaceuticals HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] 0904-5924_a2de6f88-0bdc-442a-8027-112700271cf3 0904-5924 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20090219 ANDA ANDA071208 Major Pharmaceuticals HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] 0904-5925_a2de6f88-0bdc-442a-8027-112700271cf3 0904-5925 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20090219 ANDA ANDA071209 Major Pharmaceuticals HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 0904-5928_a4f0aaa6-4b1a-42cb-b8af-e85026c6a349 0904-5928 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET ORAL 20090610 ANDA ANDA075133 Major Pharmaceuticals LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-5929_a4f0aaa6-4b1a-42cb-b8af-e85026c6a349 0904-5929 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET ORAL 20090610 ANDA ANDA075133 Major Pharmaceuticals LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-5930_a4f0aaa6-4b1a-42cb-b8af-e85026c6a349 0904-5930 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET ORAL 20090610 ANDA ANDA075133 Major Pharmaceuticals LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-5939_8193201f-4b27-4b07-b416-8124817eb0c9 0904-5939 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20090610 ANDA ANDA076009 Major Pharmaceuticals NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-5940_8193201f-4b27-4b07-b416-8124817eb0c9 0904-5940 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20090610 ANDA ANDA076009 Major Pharmaceuticals NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-5941_2597f884-d20a-40b7-9dd3-147462a04c47 0904-5941 HUMAN PRESCRIPTION DRUG Neomycin Sulfate Neomycin Sulfate TABLET ORAL 20090914 ANDA ANDA060304 Major Pharmaceuticals NEOMYCIN SULFATE 500 mg/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 0904-5951_d1b3f754-1adc-41c6-b4cd-2a3a781cc277 0904-5951 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20091102 ANDA ANDA040353 Major Pharmaceuticals SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0904-5952_d1b3f754-1adc-41c6-b4cd-2a3a781cc277 0904-5952 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20091102 ANDA ANDA040353 Major Pharmaceuticals SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0904-5953_d1b3f754-1adc-41c6-b4cd-2a3a781cc277 0904-5953 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20091102 ANDA ANDA040353 Major Pharmaceuticals SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 0904-5959_01575ac7-4967-40d8-b3fb-9fb33c424fb6 0904-5959 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20090410 ANDA ANDA065061 Major Pharmaceuticals CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 0904-5961_42579609-eccc-473c-8dd9-a94b94a74832 0904-5961 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20090610 ANDA ANDA076502 Major Pharmaceuticals FEXOFENADINE HYDROCHLORIDE 30 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0904-5962_42579609-eccc-473c-8dd9-a94b94a74832 0904-5962 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20090610 ANDA ANDA076502 Major Pharmaceuticals FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0904-5963_42579609-eccc-473c-8dd9-a94b94a74832 0904-5963 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20090610 ANDA ANDA076502 Major Pharmaceuticals FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0904-5973_af439894-3152-4f5d-9bdd-cc6ad5bd5238 0904-5973 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 Major Pharmaceuticals RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 0904-5974_af439894-3152-4f5d-9bdd-cc6ad5bd5238 0904-5974 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 Major Pharmaceuticals RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 0904-5975_af439894-3152-4f5d-9bdd-cc6ad5bd5238 0904-5975 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 Major Pharmaceuticals RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 0904-5976_af439894-3152-4f5d-9bdd-cc6ad5bd5238 0904-5976 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 Major Pharmaceuticals RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 0904-5977_af439894-3152-4f5d-9bdd-cc6ad5bd5238 0904-5977 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 Major Pharmaceuticals RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 0904-5978_af439894-3152-4f5d-9bdd-cc6ad5bd5238 0904-5978 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 Major Pharmaceuticals RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 0904-5980_0a415c46-7e3b-41f7-a64b-814fe08053ed 0904-5980 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100324 ANDA ANDA076045 Major Pharmaceuticals LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0904-5981_0a415c46-7e3b-41f7-a64b-814fe08053ed 0904-5981 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100324 ANDA ANDA076045 Major Pharmaceuticals LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0904-5982_0a415c46-7e3b-41f7-a64b-814fe08053ed 0904-5982 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100324 ANDA ANDA076045 Major Pharmaceuticals LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0904-5988_300272b1-8b53-4c43-b72d-f2820e1d0b38 0904-5988 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20100312 ANDA ANDA077836 Major Pharmaceuticals GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 0904-5990_3a88f295-bd1a-4252-9f9b-cff4c76e26cb 0904-5990 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090820 ANDA ANDA078705 Major Pharmaceuticals DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0904-5991_e17fc81d-6dda-46b8-8016-fbe13b1c0684 0904-5991 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20090610 ANDA ANDA078500 Major Pharmaceuticals AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0904-5992_e17fc81d-6dda-46b8-8016-fbe13b1c0684 0904-5992 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20090610 ANDA ANDA078500 Major Pharmaceuticals AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0904-5993_e17fc81d-6dda-46b8-8016-fbe13b1c0684 0904-5993 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20090610 ANDA ANDA078500 Major Pharmaceuticals AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0904-5994_d0ab1e66-871a-41b8-b8b7-6c7c40ea9619 0904-5994 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090708 ANDA ANDA079050 Major Pharmaceuticals ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0904-5995_d0ab1e66-871a-41b8-b8b7-6c7c40ea9619 0904-5995 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090708 ANDA ANDA079050 Major Pharmaceuticals ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0904-5996_d0ab1e66-871a-41b8-b8b7-6c7c40ea9619 0904-5996 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090708 ANDA ANDA079050 Major Pharmaceuticals ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0904-5997_d0ab1e66-871a-41b8-b8b7-6c7c40ea9619 0904-5997 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL; ORAL 20090708 ANDA ANDA079050 Major Pharmaceuticals ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0904-5998_d0ab1e66-871a-41b8-b8b7-6c7c40ea9619 0904-5998 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090708 ANDA ANDA079050 Major Pharmaceuticals ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0904-5999_d0ab1e66-871a-41b8-b8b7-6c7c40ea9619 0904-5999 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090708 ANDA ANDA079050 Major Pharmaceuticals ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0904-6000_d0ab1e66-871a-41b8-b8b7-6c7c40ea9619 0904-6000 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090708 ANDA ANDA079050 Major Pharmaceuticals ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0904-6004_4a92ffca-a913-4569-b088-5db685b557de 0904-6004 HUMAN OTC DRUG Ear Wax Remover CARBAMIDE PEROXIDE LIQUID AURICULAR (OTIC) 20090527 OTC MONOGRAPH FINAL part344 Major Pharmaceuticals CARBAMIDE PEROXIDE 65 mg/mL 0904-6007_f89ae392-10bf-4494-9334-82964127548e 0904-6007 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20091009 ANDA ANDA078203 Major Pharmaceuticals LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0904-6008_f89ae392-10bf-4494-9334-82964127548e 0904-6008 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20091009 ANDA ANDA078203 Major Pharmaceuticals LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0904-6009_f89ae392-10bf-4494-9334-82964127548e 0904-6009 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20091009 ANDA ANDA078203 Major Pharmaceuticals LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0904-6010_6ee5cfa3-11c9-4e1c-a609-888dc72c558b 0904-6010 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20090610 ANDA ANDA065404 Major Pharmaceuticals AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 0904-6012_bbc3812f-e13c-4c0a-a95c-639034808142 0904-6012 HUMAN PRESCRIPTION DRUG METHOTREXATE METHOTREXATE TABLET ORAL 20090601 NDA NDA008085 Major Pharmaceuticals METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 0904-6013_08ddc168-7a02-4448-999d-060ca75ce1d1 0904-6013 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan HBr and Guiafenesin TABLET, FILM COATED ORAL 20051231 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 0904-6016_68d6091e-fb3f-419f-b279-11f240825b07 0904-6016 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20090610 ANDA ANDA076311 Major Pharmaceuticals TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0904-6017_68d6091e-fb3f-419f-b279-11f240825b07 0904-6017 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20090610 ANDA ANDA076311 Major Pharmaceuticals TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0904-6018_68d6091e-fb3f-419f-b279-11f240825b07 0904-6018 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20090610 ANDA ANDA076311 Major Pharmaceuticals TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0904-6019_82d4877e-6ebf-4f75-a108-28dc840b07fc 0904-6019 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET ORAL 20100511 ANDA ANDA078917 Major Pharmaceuticals BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 0904-6021_5816d435-7b89-44b4-a012-d64adf02749c 0904-6021 HUMAN OTC DRUG Oral Pain Relief Anesthetic Anesthetic Benzocaine GEL ORAL 20090819 OTC MONOGRAPH NOT FINAL part356 Major Pharmaceuticals BENZOCAINE 200 mg/g 0904-6025_fc5ffc2c-976e-4997-b856-9acffe62eb8d 0904-6025 HUMAN OTC DRUG peg 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091008 ANDA ANDA090685 Major Pharmaceuticals POLYETHYLENE GLYCOL 3350 17 g/17g 0904-6033_2b7b7b54-967b-4bb8-a903-ece2811e9b3a 0904-6033 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090610 ANDA ANDA076969 Major Pharmaceuticals METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-6034_2b7b7b54-967b-4bb8-a903-ece2811e9b3a 0904-6034 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090610 ANDA ANDA076969 Major Pharmaceuticals METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-6041_93b20fd7-0d02-4ba4-bb38-bd11eab007be 0904-6041 HUMAN PRESCRIPTION DRUG sodium polystyrene sulfonate sodium polystyrene sulfonate POWDER ORAL 20091118 ANDA ANDA040905 Major Pharmaceuticals SODIUM POLYSTYRENE SULFONATE 1 g/g 0904-6045_d8ac27db-d3ff-4f7b-9480-a358becd0a58 0904-6045 HUMAN OTC DRUG 70% Isopropyl Alcohol 70% Isopropyl Alcohol LIQUID TOPICAL 20100101 OTC MONOGRAPH FINAL part344 Major Pharmaceuticals ISOPROPYL ALCOHOL 70 mL/100mL 0904-6046_c1c85b72-0883-4409-ba9c-d9f8d4f63825 0904-6046 HUMAN OTC DRUG Robafen DM Max Non drowsy Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20100713 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/5mL; mg/5mL 0904-6051_bc99b82e-1a77-4808-ae13-0a3de55755a9 0904-6051 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20130802 ANDA ANDA078858 Major Pharmaceuticals LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0904-6052_bc99b82e-1a77-4808-ae13-0a3de55755a9 0904-6052 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090731 ANDA ANDA078858 Major Pharmaceuticals LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0904-6053_bc99b82e-1a77-4808-ae13-0a3de55755a9 0904-6053 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20130802 ANDA ANDA078858 Major Pharmaceuticals LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0904-6061_dd6f3db2-1424-42b9-8ac5-e7fcf3089758 0904-6061 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20090809 ANDA ANDA075022 Major Pharmaceuticals BUSPIRONE HYDROCHLORIDE 15 mg/1 0904-6068_1ef09d8b-4464-440a-900c-51baffa96d0f 0904-6068 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20090825 ANDA ANDA075604 Major Pharmaceuticals POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0904-6069_208389e6-ebbc-4e23-8312-e68bb6f697f0 0904-6069 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20090810 ANDA ANDA075927 Major Pharmaceuticals NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-6073_3a88f295-bd1a-4252-9f9b-cff4c76e26cb 0904-6073 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090820 ANDA ANDA078705 Major Pharmaceuticals DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0904-6074_18ddf7c7-655e-46df-9d2f-400e453cb47a 0904-6074 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030828 ANDA ANDA076134 Major Pharmaceuticals LORATADINE 10 mg/1 0904-6074_240ff2a7-7493-4d90-ac7a-c4885f7899a3 0904-6074 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20100615 ANDA ANDA076134 Major Pharmaceuticals LORATADINE 10 mg/1 0904-6078_1fe1f09c-85b9-491f-b3aa-78359448d004 0904-6078 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100510 ANDA ANDA078428 Major Pharmaceuticals GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0904-6079_1fe1f09c-85b9-491f-b3aa-78359448d004 0904-6079 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100510 ANDA ANDA078428 Major Pharmaceuticals GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0904-6080_e91ce413-8f8f-40a6-b78e-1c64b0c1bae4 0904-6080 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20100723 ANDA ANDA077824 Major Pharmaceuticals RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0904-6082_21569835-b4e9-4eb5-8eea-db84ba20bf40 0904-6082 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET ORAL 20091102 ANDA ANDA077903 Major Pharmaceuticals ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0904-6083_21569835-b4e9-4eb5-8eea-db84ba20bf40 0904-6083 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET ORAL 20091102 ANDA ANDA077903 Major Pharmaceuticals ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0904-6084_d51acec9-fb9e-4140-827e-ae9c376d172b 0904-6084 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20091102 ANDA ANDA078216 Major Pharmaceuticals CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6085_d51acec9-fb9e-4140-827e-ae9c376d172b 0904-6085 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20091102 ANDA ANDA078216 Major Pharmaceuticals CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6086_d51acec9-fb9e-4140-827e-ae9c376d172b 0904-6086 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20091102 ANDA ANDA078216 Major Pharmaceuticals CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6087_01315e8f-278d-42cc-af60-b9bf55bc5713 0904-6087 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Tablets sertraline hydrochloride TABLET, FILM COATED ORAL 20091110 ANDA ANDA077397 Major Pharmaceuticals SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6088_01315e8f-278d-42cc-af60-b9bf55bc5713 0904-6088 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Tablets sertraline hydrochloride TABLET, FILM COATED ORAL 20091110 ANDA ANDA077397 Major Pharmaceuticals SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6089_01315e8f-278d-42cc-af60-b9bf55bc5713 0904-6089 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Tablets sertraline hydrochloride TABLET, FILM COATED ORAL 20091110 ANDA ANDA077397 Major Pharmaceuticals SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6090_a4300850-de1e-4e1c-bada-87ebe5ba2fe8 0904-6090 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100111 ANDA ANDA077880 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0904-6091_a4300850-de1e-4e1c-bada-87ebe5ba2fe8 0904-6091 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100111 ANDA ANDA077880 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0904-6092_a4300850-de1e-4e1c-bada-87ebe5ba2fe8 0904-6092 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100111 ANDA ANDA077880 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0904-6093_3c8682d6-b8f2-47b6-8fb1-22195e3323c9 0904-6093 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20100426 ANDA ANDA075584 Major Pharmaceuticals BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0904-6096_f04109ce-7086-4026-9ce2-6912293925b8 0904-6096 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20100618 ANDA ANDA078251 Major Pharmaceuticals CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0904-6097_f04109ce-7086-4026-9ce2-6912293925b8 0904-6097 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20100604 ANDA ANDA078251 Major Pharmaceuticals CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0904-6098_f04109ce-7086-4026-9ce2-6912293925b8 0904-6098 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20100607 ANDA ANDA078251 Major Pharmaceuticals CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0904-6099_f04109ce-7086-4026-9ce2-6912293925b8 0904-6099 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20100618 ANDA ANDA078251 Major Pharmaceuticals CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0904-6100_f92d08e7-e530-4fbd-b196-287a9483467d 0904-6100 HUMAN OTC DRUG Cetirizine hydrochloride Cetirizine hydrochloride TABLET ORAL 20100625 ANDA ANDA077498 Major Pharmaceuticals CETIRIZINE HYDROCHLORIDE 10 mg/1 0904-6101_a4a0901e-42fe-44ac-9c8b-e958e7e1b937 0904-6101 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20100514 ANDA ANDA074979 Major Pharmaceuticals CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0904-6102_a4a0901e-42fe-44ac-9c8b-e958e7e1b937 0904-6102 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20100514 ANDA ANDA074979 Major Pharmaceuticals CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0904-6103_a4a0901e-42fe-44ac-9c8b-e958e7e1b937 0904-6103 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20100617 ANDA ANDA074979 Major Pharmaceuticals CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 0904-6105_1fe1f09c-85b9-491f-b3aa-78359448d004 0904-6105 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100510 ANDA ANDA078428 Major Pharmaceuticals GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0904-6107_18788a66-5e81-46f6-b738-e8e7dadff586 0904-6107 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100517 ANDA ANDA078596 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0904-6108_18788a66-5e81-46f6-b738-e8e7dadff586 0904-6108 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100510 ANDA ANDA078596 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0904-6109_f1c61a50-be15-49b6-8bc6-2efbe0a2d402 0904-6109 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET, FILM COATED ORAL 20100607 ANDA ANDA077584 Major Pharmaceuticals PAROXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6110_f1c61a50-be15-49b6-8bc6-2efbe0a2d402 0904-6110 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET, FILM COATED ORAL 20100607 ANDA ANDA077584 Major Pharmaceuticals PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6111_f1c61a50-be15-49b6-8bc6-2efbe0a2d402 0904-6111 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET, FILM COATED ORAL 20100607 ANDA ANDA077584 Major Pharmaceuticals PAROXETINE HYDROCHLORIDE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6112_f1c61a50-be15-49b6-8bc6-2efbe0a2d402 0904-6112 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET, FILM COATED ORAL 20100607 ANDA ANDA077584 Major Pharmaceuticals PAROXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6113_a7a0e160-3d6f-463c-a433-d758f9297d26 0904-6113 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20100706 ANDA ANDA077987 Major Pharmaceuticals PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0904-6114_a7a0e160-3d6f-463c-a433-d758f9297d26 0904-6114 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20100706 ANDA ANDA077987 Major Pharmaceuticals PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0904-6115_a7a0e160-3d6f-463c-a433-d758f9297d26 0904-6115 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20100706 ANDA ANDA077987 Major Pharmaceuticals PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0904-6117_e91ce413-8f8f-40a6-b78e-1c64b0c1bae4 0904-6117 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20100723 ANDA ANDA077824 Major Pharmaceuticals RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 0904-6119_8235cb6b-6696-4e8f-a195-e1cf39dbf3f7 0904-6119 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20100301 ANDA ANDA076003 Major Pharmaceuticals TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 0904-6121_58db3efc-09c8-470c-b175-4f35e418c61e 0904-6121 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20100614 ANDA ANDA074980 Major Pharmaceuticals ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 0904-6123_81c58325-6dcf-4361-8ef2-92c5638265e3 0904-6123 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20100111 20151006 ANDA ANDA074305 Major Pharmaceuticals GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0904-6124_81c58325-6dcf-4361-8ef2-92c5638265e3 0904-6124 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20100111 20151003 ANDA ANDA074305 Major Pharmaceuticals GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0904-6125_2f7c8e55-9b86-4a2f-b0d1-75807c8116f0 0904-6125 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20091102 ANDA ANDA074823 Major Pharmaceuticals TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0904-6126_2f7c8e55-9b86-4a2f-b0d1-75807c8116f0 0904-6126 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20091102 ANDA ANDA074823 Major Pharmaceuticals TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0904-6127_2f7c8e55-9b86-4a2f-b0d1-75807c8116f0 0904-6127 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20091102 ANDA ANDA074823 Major Pharmaceuticals TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0904-6128_2f7c8e55-9b86-4a2f-b0d1-75807c8116f0 0904-6128 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20091102 ANDA ANDA074823 Major Pharmaceuticals TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0904-6129_3c8682d6-b8f2-47b6-8fb1-22195e3323c9 0904-6129 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20100426 ANDA ANDA075584 Major Pharmaceuticals BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 0904-6133_36e1d697-daf6-43be-883d-57422eb07eab 0904-6133 HUMAN OTC DRUG mucus er Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130320 ANDA ANDA078912 Major Pharmaceuticals GUAIFENESIN 600 mg/1 0904-6135_0c6a3169-9079-4ecf-af30-4acec3fd7274 0904-6135 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20100504 ANDA ANDA075757 Major Pharmaceuticals OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0904-6136_f9aea785-f0a1-4716-8bb4-dfe4d9900f4e 0904-6136 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20030224 ANDA ANDA076243 Major Pharmaceuticals LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 0904-6137_b6a2d061-8197-437e-9769-f66c0a72ff5c 0904-6137 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20020806 ANDA ANDA076257 Major Pharmaceuticals GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0904-6138_b6a2d061-8197-437e-9769-f66c0a72ff5c 0904-6138 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20020806 ANDA ANDA076257 Major Pharmaceuticals GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0904-6139_b6a2d061-8197-437e-9769-f66c0a72ff5c 0904-6139 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20020806 ANDA ANDA076257 Major Pharmaceuticals GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 0904-6140_9bbfe817-0d84-4926-8e76-1c67dc557682 0904-6140 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20100506 ANDA ANDA076161 Major Pharmaceuticals DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0904-6141_9bbfe817-0d84-4926-8e76-1c67dc557682 0904-6141 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20100428 ANDA ANDA076161 Major Pharmaceuticals DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0904-6142_9bbfe817-0d84-4926-8e76-1c67dc557682 0904-6142 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20100428 ANDA ANDA076161 Major Pharmaceuticals DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0904-6143_9bbfe817-0d84-4926-8e76-1c67dc557682 0904-6143 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20100428 ANDA ANDA076161 Major Pharmaceuticals DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0904-6144_0c6a3169-9079-4ecf-af30-4acec3fd7274 0904-6144 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20100716 ANDA ANDA076515 Major Pharmaceuticals OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 0904-6149_eab76340-2118-49dd-8501-aefe88ee4429 0904-6149 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100512 ANDA ANDA074984 Major Pharmaceuticals DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 0904-6156_cbd109df-88a1-4845-8fb0-4c250d7fd497 0904-6156 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100510 ANDA ANDA078938 Major Pharmaceuticals TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 0904-6158_8d7ce934-595e-4292-81f9-4dafd7cb207f 0904-6158 HUMAN OTC DRUG infants acetaminophen Acetaminophen SUSPENSION/ DROPS ORAL 20101112 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 80 mg/.8mL 0904-6162_1c6741c5-84ec-4510-92a3-b0ed527a2e74 0904-6162 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20100517 ANDA ANDA078459 Major Pharmaceuticals METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-6169_be3256af-2378-4907-b218-c4fe1057a0a3 0904-6169 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101005 ANDA ANDA090615 Major Pharmaceuticals METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-6170_be3256af-2378-4907-b218-c4fe1057a0a3 0904-6170 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101005 ANDA ANDA090615 Major Pharmaceuticals METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-6171_be3256af-2378-4907-b218-c4fe1057a0a3 0904-6171 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101005 ANDA ANDA090615 Major Pharmaceuticals METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-6172_bf4bf9c4-4c23-4e96-a0b5-a0c4e65da50e 0904-6172 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20100920 ANDA ANDA077272 Major Pharmaceuticals CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 0904-6173_b24d3d60-0118-43f6-b428-76121b27de9a 0904-6173 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20091201 ANDA ANDA075047 Major Pharmaceuticals ACEBUTOLOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-6174_54e05bc8-8609-4fb0-9a62-7dba80691b9a 0904-6174 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20101203 ANDA ANDA078477 Major Pharmaceuticals AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0904-6175_54e05bc8-8609-4fb0-9a62-7dba80691b9a 0904-6175 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20101203 ANDA ANDA078477 Major Pharmaceuticals AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0904-6176_0bd93751-f0f9-4871-9e43-19accbb5d74a 0904-6176 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100401 ANDA ANDA040855 Major Pharmaceuticals BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0904-6177_0bd93751-f0f9-4871-9e43-19accbb5d74a 0904-6177 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100401 ANDA ANDA040855 Major Pharmaceuticals BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0904-6178_0bd93751-f0f9-4871-9e43-19accbb5d74a 0904-6178 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100401 ANDA ANDA040855 Major Pharmaceuticals BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0904-6181_6cb34dc8-c9b6-4f4c-bd37-a88122990730 0904-6181 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET ORAL 20101119 ANDA ANDA065425 Major Pharmaceuticals DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 0904-6183_79926161-4e38-4adc-9598-681ba1309568 0904-6183 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine Hydrochloride TABLET ORAL 19981125 ANDA ANDA075109 Major Pharmaceuticals GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0904-6184_79926161-4e38-4adc-9598-681ba1309568 0904-6184 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine Hydrochloride TABLET ORAL 19981125 ANDA ANDA075109 Major Pharmaceuticals GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0904-6185_2e56c449-21cf-47b1-8b7c-d561ddf86e49 0904-6185 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Major Pharmaceuticals NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-6186_2e56c449-21cf-47b1-8b7c-d561ddf86e49 0904-6186 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Major Pharmaceuticals NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-6187_89f853bd-9faa-4825-9deb-058f975b178a 0904-6187 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE ORAL 20091216 ANDA ANDA040765 Major Pharmaceuticals PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0904-6188_54e05bc8-8609-4fb0-9a62-7dba80691b9a 0904-6188 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20101203 ANDA ANDA078477 Major Pharmaceuticals AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0904-6189_d243a93c-d2f3-426d-90f0-e30ff512a356 0904-6189 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Major Pharmaceuticals BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0904-6190_d243a93c-d2f3-426d-90f0-e30ff512a356 0904-6190 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Major Pharmaceuticals BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0904-6191_d243a93c-d2f3-426d-90f0-e30ff512a356 0904-6191 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Major Pharmaceuticals BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0904-6192_d243a93c-d2f3-426d-90f0-e30ff512a356 0904-6192 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Major Pharmaceuticals BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 0904-6193_eac173d6-c684-48e5-bc3b-b8badd965442 0904-6193 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride TABLET ORAL 20100716 ANDA ANDA076280 Major Pharmaceuticals TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0904-6195_f1dd6e31-0c04-4fd6-8e74-ee09d5cebde8 0904-6195 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100615 ANDA ANDA090568 Major Pharmaceuticals ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 0904-6200_4cef3e31-982e-4f7c-8ade-0006a586d74e 0904-6200 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19930429 ANDA ANDA073582 Major Pharmaceutical ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 0904-6201_22ba7057-8d8a-45d3-8969-19908e78ebe4 0904-6201 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091202 ANDA ANDA040765 Major Pharmaceuticals FOLIC ACID 1 mg/1 0904-6203_5d8432b7-4879-4cdf-bde4-8107d4fb5083 0904-6203 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720228 ANDA ANDA080212 Major Pharmaceuticals ISONIAZID 300 mg/1 Antimycobacterial [EPC] 0904-6204_b4089de1-f350-4131-b8c4-991b92ba4f8e 0904-6204 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20030617 ANDA ANDA076490 Major Pharmaceuticals LITHIUM CARBONATE 450 mg/1 0904-6205_f9aea785-f0a1-4716-8bb4-dfe4d9900f4e 0904-6205 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20030224 ANDA ANDA076243 Major Pharmaceuticals LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] 0904-6207_b6d13c1d-6e1b-4d12-be38-d7378eb4c73b 0904-6207 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20091224 ANDA ANDA040866 Major Pharmaceuticals PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 0904-6208_24db531e-d92d-4755-a106-166c5e7a16dc 0904-6208 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron hydrochloride TABLET ORAL 20080101 ANDA ANDA077545 Major Pharmaceuticals ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0904-6209_24db531e-d92d-4755-a106-166c5e7a16dc 0904-6209 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron hydrochloride TABLET ORAL 20080101 ANDA ANDA077545 Major Pharmaceuticals ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 0904-6214_c93a9479-02ba-4b5e-a013-9cc826dc3c3b 0904-6214 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Major Pharmaceuticals FEXOFENADINE HYDROCHLORIDE 180 mg/1 0904-6216_2b41e720-b004-4794-91f1-da24729a0f64 0904-6216 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20101130 ANDA ANDA072711 Major Pharmaceuticals SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-6217_2b41e720-b004-4794-91f1-da24729a0f64 0904-6217 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20101130 ANDA ANDA072711 Major Pharmaceuticals SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-6221_e7c8380e-620f-4046-b0ef-f4b1ee0022b4 0904-6221 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20110401 ANDA ANDA075517 Major Pharmaceuticals URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 0904-6229_2a850675-fc60-44e5-bd2d-c11f076fe7a9 0904-6229 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20101226 ANDA ANDA079220 Major Pharmaceuticals ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 0904-6232_02ccb178-7f9c-459c-80cf-e06df6964b48 0904-6232 HUMAN OTC DRUG MUCUS RELIEF GUAIFENESIN TABLET ORAL 20120723 OTC MONOGRAPH FINAL part341 MAJOR PHARMACEUTICALS INC GUAIFENESIN 400 mg/1 0904-6233_98770781-a4cb-48f7-ab08-1495f75c5acb 0904-6233 HUMAN OTC DRUG MUCUS RELIEF DM GUAIFENESIN, DEXTROMETHORPHAN HBr TABLET ORAL 20120723 OTC MONOGRAPH FINAL part341 MAJOR PHARMACEUTICALS INC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 0904-6234_cbc33bcc-7963-47c9-a772-d303fe771c41 0904-6234 HUMAN OTC DRUG Loratadine Loratadine SOLUTION ORAL 20110217 ANDA ANDA077421 Major Pharmaceuticals, Inc LORATADINE 5 mg/5mL 0904-6235_a1488673-599d-4980-8816-8a53a2b41515 0904-6235 HUMAN PRESCRIPTION DRUG Pantoprazole Pantoprazole TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA077619 Major Pharmaceuticals PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0904-6237_d5979456-a1b8-4860-b204-9ba0e94ed005 0904-6237 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20110211 ANDA ANDA074260 Major Pharmaceuticals CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0904-6238_d5979456-a1b8-4860-b204-9ba0e94ed005 0904-6238 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20110211 ANDA ANDA074260 Major Pharmaceuticals CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0904-6242_dfbeab53-b8aa-4cac-9ba3-1b0d621b8c23 0904-6242 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110607 ANDA ANDA091267 Major Pharmaceuticals DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0904-6243_dfbeab53-b8aa-4cac-9ba3-1b0d621b8c23 0904-6243 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110607 ANDA ANDA091267 Major Pharmaceuticals DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0904-6245_89390611-265d-4f18-8b01-700e1bdc0788 0904-6245 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20110421 OTC MONOGRAPH NOT FINAL part333A Major Pharmaceuticals ISOPROPYL ALCOHOL 1.4 mL/1 0904-6246_7828978f-4109-4a7b-8199-98ed2017239d 0904-6246 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110607 ANDA ANDA078865 Major Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6247_7828978f-4109-4a7b-8199-98ed2017239d 0904-6247 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110607 ANDA ANDA078865 Major Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6248_7828978f-4109-4a7b-8199-98ed2017239d 0904-6248 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110607 ANDA ANDA078865 Major Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6249_7854cf56-ffc0-4692-8c80-b966b49b7029 0904-6249 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110623 ANDA ANDA090367 Major Pharmaceuticals LEVOFLOXACIN 250 mg/1 0904-6250_7854cf56-ffc0-4692-8c80-b966b49b7029 0904-6250 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110623 ANDA ANDA090367 Major Pharmaceuticals LEVOFLOXACIN 500 mg/1 0904-6251_7854cf56-ffc0-4692-8c80-b966b49b7029 0904-6251 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110623 ANDA ANDA090367 Major Pharmaceuticals LEVOFLOXACIN 750 mg/1 0904-6252_031b5443-aae9-463f-9f63-8a8c9c6edb34 0904-6252 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110714 ANDA ANDA091179 Major Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 0904-6254_8e20e385-99a1-4ead-8964-fa9fe18a0374 0904-6254 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 Major Pharmaceuticals BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 0904-6255_c656fe47-8ea0-46a8-9e31-ff0a5719d28d 0904-6255 HUMAN OTC DRUG Sore Throat Logenzes Sore Throat Benzocaine and Menthol LOZENGE ORAL 20121228 OTC MONOGRAPH NOT FINAL part356 Major Pharmaceuticals BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 0904-6256_e9546f52-c2d3-4e9b-b716-c42195978f9b 0904-6256 HUMAN OTC DRUG loperamide hydrochloride loperamide HCl LIQUID ORAL 20120314 ANDA ANDA091292 Major Pharmaceuticals LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 0904-6257_2025c71d-d752-4bea-bc4c-7beff1b63ff9 0904-6257 HUMAN OTC DRUG nicorelief Nicotine Polacrilex LOZENGE ORAL 20071023 ANDA ANDA077007 Major Pharmaceuticals NICOTINE 2 mg/1 0904-6258_24791e4d-75e9-4638-99af-fcc4f56538c8 0904-6258 HUMAN OTC DRUG nicorelief Nicotine Polacrilex LOZENGE ORAL 20071119 ANDA ANDA077007 Major Pharmaceuticals NICOTINE 4 mg/1 0904-6266_e487c98e-a33f-4ad1-be35-e121ed0d194d 0904-6266 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET, COATED ORAL 20111201 ANDA ANDA071586 Major Pharmaceuticals ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 0904-6267_e487c98e-a33f-4ad1-be35-e121ed0d194d 0904-6267 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET, COATED ORAL 20111201 ANDA ANDA071587 Major Pharmaceuticals ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 0904-6269_8bc8a69d-0441-46bf-b05e-32b92b9584ad 0904-6269 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120315 ANDA ANDA077565 Major Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 0904-6270_8bc8a69d-0441-46bf-b05e-32b92b9584ad 0904-6270 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120315 ANDA ANDA077565 Major Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 0904-6271_8bc8a69d-0441-46bf-b05e-32b92b9584ad 0904-6271 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120315 ANDA ANDA077565 Major Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 0904-6272_8bc8a69d-0441-46bf-b05e-32b92b9584ad 0904-6272 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120315 ANDA ANDA077565 Major Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 0904-6277_5609a35d-c437-4584-874b-6fc51fd56a62 0904-6277 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Major Pharmaceuticals QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 0904-6278_5609a35d-c437-4584-874b-6fc51fd56a62 0904-6278 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Major Pharmaceuticals QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 0904-6279_5609a35d-c437-4584-874b-6fc51fd56a62 0904-6279 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Major Pharmaceuticals QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 0904-6280_5609a35d-c437-4584-874b-6fc51fd56a62 0904-6280 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Major Pharmaceuticals QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 0904-6281_5609a35d-c437-4584-874b-6fc51fd56a62 0904-6281 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Major Pharmaceuticals QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 0904-6282_6ac27ac4-7056-469c-a5ee-046eddc79e54 0904-6282 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120329 ANDA ANDA202727 Major Pharmaceuticals LANSOPRAZOLE 15 mg/1 0904-6283_5105c37a-3bb7-4831-b7bb-98e91b196059 0904-6283 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Major Pharmaceuticals OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 0904-6284_5105c37a-3bb7-4831-b7bb-98e91b196059 0904-6284 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Major Pharmaceuticals OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 0904-6285_5105c37a-3bb7-4831-b7bb-98e91b196059 0904-6285 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Major Pharmaceuticals OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 0904-6286_ab39d3e4-9512-4a5b-9725-e1943dc494d5 0904-6286 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076133 Major Pharmaceuticals OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 0904-6287_ab39d3e4-9512-4a5b-9725-e1943dc494d5 0904-6287 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076133 Major Pharmaceuticals OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 0904-6288_36e4df5d-091e-4446-a46c-4e411fbaf669 0904-6288 HUMAN OTC DRUG aspirin aspirin TABLET ORAL 20100716 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals ASPIRIN 81 mg/1 0904-6289_5406ae9f-e1bf-4a65-bf8b-327e80c93dfd 0904-6289 HUMAN OTC DRUG Senna Sennosides A and B SYRUP ORAL 20120423 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals SENNOSIDES A AND B 8.8 mg/5mL 0904-6290_66d59e25-71d3-4028-ac91-59f52afa0475 0904-6290 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Major Pharmaceuticals ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0904-6291_66d59e25-71d3-4028-ac91-59f52afa0475 0904-6291 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Major Pharmaceuticals ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0904-6292_b820f9d0-b8d6-42b2-b6f7-d78cc4a15d6c 0904-6292 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20141031 ANDA ANDA090548 Major Pharmaceuticals ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0904-6293_b820f9d0-b8d6-42b2-b6f7-d78cc4a15d6c 0904-6293 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20141031 ANDA ANDA090548 Major Pharmaceuticals ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 0904-6294_9ce00e3b-9d31-47f7-8244-9df356c3c47c 0904-6294 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET ORAL 20120517 ANDA ANDA090844 Major Pharmaceuticals CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 0904-6295_c8280b83-ec9e-480a-99b4-53a84e931060 0904-6295 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110228 ANDA ANDA091416 Major Pharmaceuticals NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-6296_c8280b83-ec9e-480a-99b4-53a84e931060 0904-6296 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110228 ANDA ANDA091416 Major Pharmaceuticals NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-6297_c8280b83-ec9e-480a-99b4-53a84e931060 0904-6297 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110228 ANDA ANDA091416 Major Pharmaceuticals NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 0904-6300_15c67951-e6bc-4cf6-a147-1a3e98b9679b 0904-6300 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 Major Pharmaceuticals CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0904-6301_15c67951-e6bc-4cf6-a147-1a3e98b9679b 0904-6301 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 Major Pharmaceuticals CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0904-6302_15c67951-e6bc-4cf6-a147-1a3e98b9679b 0904-6302 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 Major Pharmaceuticals CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0904-6303_15c67951-e6bc-4cf6-a147-1a3e98b9679b 0904-6303 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070906 ANDA ANDA078227 Major Pharmaceuticals CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 0904-6304_5717d2cf-4ce1-4d51-b7e0-f3c4e00f9ad5 0904-6304 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20120827 OTC MONOGRAPH FINAL part334 Major Pharmaceuticals MAGNESIUM CITRATE 1.745 g/29.6mL 0904-6306_b933f658-7f7b-4397-893b-4ab2386179ec 0904-6306 HUMAN OTC DRUG Robafen DM Cough Sugar Free Clear Guaifenesin and Dextromethorphan Hydrobromide SOLUTION ORAL 20121220 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 0904-6307_fa48e413-2429-4a66-8e7a-03e6facdccbd 0904-6307 HUMAN OTC DRUG Infants MAPAP Acetaminophen SUSPENSION ORAL 20120601 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 160 mg/5mL 0904-6308_f742e767-2e6e-495a-b869-21eeaf3fa3b6 0904-6308 HUMAN OTC DRUG Childrens MAPAP Acetaminophen SUSPENSION ORAL 20121114 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 160 mg/5mL 0904-6309_3f0ca421-52ee-4fd7-9a1b-284394476185 0904-6309 HUMAN OTC DRUG Robafen CF Cough and cold Guaifenesin, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride SOLUTION ORAL 20130305 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 0904-6310_2fd38014-f01f-4385-8775-985cb1224bfe 0904-6310 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET ORAL 20120803 ANDA ANDA201515 Major Pharmaceuticals MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 0904-6311_596109bc-877d-4748-ac2d-1d554a3b8515 0904-6311 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET ORAL 20120904 ANDA ANDA079112 Major Pharmaceuticals FEXOFENADINE HYDROCHLORIDE 180 mg/1 0904-6312_cdb5616e-0f04-4b9e-a82b-994e9ba3b515 0904-6312 HUMAN OTC DRUG cough dm dextromethorphan polistirex SUSPENSION ORAL 20120906 ANDA ANDA091135 Major Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 0904-6314_5cf8303e-7237-424f-973f-519e6681713a 0904-6314 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA078777 Major Pharmaceuticals ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6315_5cf8303e-7237-424f-973f-519e6681713a 0904-6315 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA078777 Major Pharmaceuticals ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6316_94d5036e-8f15-44f2-9820-a5eceb573e9b 0904-6316 HUMAN OTC DRUG Earwax Removal Aid CARBAMIDE PEROXIDE LIQUID AURICULAR (OTIC) 20110523 OTC MONOGRAPH FINAL part344 Major Pharmaceuticals CARBAMIDE PEROXIDE 65 mg/mL 0904-6317_b1bc6bc3-5594-4cc8-95a5-215f91be8e5c 0904-6317 HUMAN PRESCRIPTION DRUG Aurodex ANTIPYRINE, BENZOCAINE OTIC SOLUTION AURICULAR (OTIC) 20090827 UNAPPROVED DRUG OTHER Major Pharmaceuticals ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 0904-6319_2ad9974c-efd5-476b-bc11-c978c3400ed4 0904-6319 HUMAN OTC DRUG Major Prep Hemorrhoidal Mineral Oil, Petrolatum, Phenylephrine Hydrochloride OINTMENT RECTAL; TOPICAL 20130630 OTC MONOGRAPH FINAL part346 Major Pharmaceuticals MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/g; mg/g; mg/g 0904-6320_ebbf25fb-dd7f-4155-a04b-feb4ccfb8d0e 0904-6320 HUMAN OTC DRUG Saline Laxative Saline Laxative ENEMA RECTAL 20130711 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/133mL; g/133mL 0904-6322_7a108a92-0510-48e3-bc8c-efd5a3b4ae60 0904-6322 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Major Pharmaceuticals METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-6323_7a108a92-0510-48e3-bc8c-efd5a3b4ae60 0904-6323 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Major Pharmaceuticals METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-6324_261424c1-6c59-4f07-bbc5-f3e63d5541d3 0904-6324 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA078889 Major Pharmaceuticals METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-6326_748a6574-4f0f-48c5-bd90-68f5930356ca 0904-6326 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0904-6327_748a6574-4f0f-48c5-bd90-68f5930356ca 0904-6327 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0904-6328_748a6574-4f0f-48c5-bd90-68f5930356ca 0904-6328 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0904-6329_0c8c69c1-f19a-45a9-aade-4b5f15ec1c2f 0904-6329 HUMAN OTC DRUG lubricating plus carboxymethylcellulose sodium SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130509 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals CARBOXYMETHYLCELLULOSE SODIUM .5 g/100mL 0904-6331_6c120728-527e-4e79-9951-5af61f9e3480 0904-6331 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20130515 ANDA ANDA077397 Major Pharmaceuticals SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6332_6c120728-527e-4e79-9951-5af61f9e3480 0904-6332 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20130515 ANDA ANDA077397 Major Pharmaceuticals SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6333_6c120728-527e-4e79-9951-5af61f9e3480 0904-6333 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20130515 ANDA ANDA077397 Major Pharmaceuticals SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6334_c91bada6-602e-4407-9fb7-b32734e9996e 0904-6334 HUMAN OTC DRUG Major Redness Reliever Eye Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20141125 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mg 0904-6337_5229f4b2-a194-46f8-a0bc-4510fbe52075 0904-6337 HUMAN OTC DRUG SudoGest Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 19910910 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 0904-6338_bb1c802a-496a-4de6-a8fa-ff0fb4f09255 0904-6338 HUMAN OTC DRUG SudoGest PSEUDOEPHEDRINE HCL TABLET, COATED ORAL 20140217 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 0904-6339_9a880e33-65ac-4bd3-8189-c68b67526b38 0904-6339 HUMAN OTC DRUG Senna Plus standardized senna concentrate and docusate sodium TABLET ORAL 20100114 UNAPPROVED DRUG OTHER Major Pharmaceuticals DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 0904-6340_2c986b19-9665-467a-a5fc-ff647c085316 0904-6340 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20130825 ANDA ANDA202871 Major Pharmaceuticals METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-6341_2c986b19-9665-467a-a5fc-ff647c085316 0904-6341 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20130825 ANDA ANDA202871 Major Pharmaceuticals METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-6342_2c986b19-9665-467a-a5fc-ff647c085316 0904-6342 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20130825 ANDA ANDA202871 Major Pharmaceuticals METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 0904-6343_2456c279-fa84-4cb3-a5cb-036d10b33955 0904-6343 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20140203 ANDA ANDA075965 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0904-6344_2456c279-fa84-4cb3-a5cb-036d10b33955 0904-6344 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20140203 ANDA ANDA075965 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0904-6345_2456c279-fa84-4cb3-a5cb-036d10b33955 0904-6345 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20140203 ANDA ANDA075965 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 0904-6346_d13bb64e-c8db-43d9-b7d7-7b2197eb6d87 0904-6346 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880107 ANDA ANDA086223 Major Pharmaceuticals ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0904-6347_d13bb64e-c8db-43d9-b7d7-7b2197eb6d87 0904-6347 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880407 ANDA ANDA089367 Major Pharmaceuticals ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 0904-6348_0c34860a-cff1-49a2-b4eb-68fc76a6c309 0904-6348 HUMAN OTC DRUG Body Menthol POWDER TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 Major Pharmaceuticals MENTHOL 1.5 mg/g 0904-6349_9ebd3eac-89f9-4868-8130-88d82f1af3d8 0904-6349 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20131001 ANDA ANDA201745 Major Pharmaceuticals RANITIDINE HYDROCHLORIDE 75 mg/1 0904-6350_9ebbf8cc-e795-42a8-a210-de72db118f05 0904-6350 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20131001 ANDA ANDA200536 Major Pharmaceuticals RANITIDINE HYDROCHLORIDE 150 mg/1 0904-6351_a79a62f8-e966-4427-be52-23f7c8ffdcb6 0904-6351 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131201 ANDA ANDA076710 Major Pharmaceuticals LEVOFLOXACIN 250 mg/1 0904-6352_a79a62f8-e966-4427-be52-23f7c8ffdcb6 0904-6352 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131201 ANDA ANDA076710 Major Pharmaceuticals LEVOFLOXACIN 500 mg/1 0904-6353_a79a62f8-e966-4427-be52-23f7c8ffdcb6 0904-6353 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131201 ANDA ANDA076710 Major Pharmaceuticals LEVOFLOXACIN 750 mg/1 0904-6354_6151d334-68c8-4b69-ab71-9dba58d10a11 0904-6354 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA201001 Major Pharmaceuticals DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0904-6355_6151d334-68c8-4b69-ab71-9dba58d10a11 0904-6355 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA201001 Major Pharmaceuticals DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0904-6356_2b04a62e-7d9a-4aa6-b75b-bb999afabbe7 0904-6356 HUMAN OTC DRUG Major Prep Hemorrhoidal Mineral Oil, Petrolatum, Phenylephrine Hydrochloride OINTMENT RECTAL; TOPICAL 20140603 OTC MONOGRAPH FINAL part346 Major Pharmaceuticals MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 749; 2.5 mg/g; mg/g; mg/g 0904-6357_979b8472-d147-4095-8358-7706d84b166a 0904-6357 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20131130 ANDA ANDA079088 Major Pharmaceuticals RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 0904-6358_979b8472-d147-4095-8358-7706d84b166a 0904-6358 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20131130 ANDA ANDA079088 Major Pharmaceuticals RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 0904-6359_979b8472-d147-4095-8358-7706d84b166a 0904-6359 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20131130 ANDA ANDA079088 Major Pharmaceuticals RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 0904-6360_979b8472-d147-4095-8358-7706d84b166a 0904-6360 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20131130 ANDA ANDA079088 Major Pharmaceuticals RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 0904-6361_979b8472-d147-4095-8358-7706d84b166a 0904-6361 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20131130 ANDA ANDA079088 Major Pharmaceuticals RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 0904-6362_979b8472-d147-4095-8358-7706d84b166a 0904-6362 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20131130 ANDA ANDA079088 Major Pharmaceuticals RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 0904-6363_7f9e5ff2-aad3-49b0-827d-2462d6c93aaa 0904-6363 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20130811 ANDA ANDA090161 Major Pharmaceuticals DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0904-6364_8c4514cf-c902-4fb6-a276-5a77dbe4c256 0904-6364 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20130811 ANDA ANDA090070 Major Pharmaceuticals DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 0904-6365_e76e6bef-3481-4059-b595-cef7c6c86f8d 0904-6365 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20140226 ANDA ANDA090404 Major Pharmaceuticals TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 0904-6366_2ff50c82-8dca-4a67-84d3-7711ec6c4ff7 0904-6366 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Major Pharmaceuticals DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6367_2ff50c82-8dca-4a67-84d3-7711ec6c4ff7 0904-6367 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Major Pharmaceuticals DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6368_2ff50c82-8dca-4a67-84d3-7711ec6c4ff7 0904-6368 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Major Pharmaceuticals DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6369_df5b9a4c-a2e7-48ff-aac5-a9ca1d4a8a91 0904-6369 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20130120 ANDA ANDA078226 Major Pharmaceuticals AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0904-6370_df5b9a4c-a2e7-48ff-aac5-a9ca1d4a8a91 0904-6370 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20130120 ANDA ANDA078226 Major Pharmaceuticals AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0904-6371_df5b9a4c-a2e7-48ff-aac5-a9ca1d4a8a91 0904-6371 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20130120 ANDA ANDA078226 Major Pharmaceuticals AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 0904-6372_a74953bf-4f20-4b12-919d-12b4c6d5c496 0904-6372 HUMAN OTC DRUG Cetrizine Hydrochloride CETIRIZINE HYDROCHLORIDE SOLUTION ORAL 20140224 ANDA ANDA090474 Major Pharmaceuticals CETIRIZINE HYDROCHLORIDE 1 mg/mL 0904-6373_42449efa-f994-4938-ab83-1a6dce73809c 0904-6373 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141001 ANDA ANDA090429 Major Pharmaceuticals ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0904-6374_42449efa-f994-4938-ab83-1a6dce73809c 0904-6374 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141001 ANDA ANDA090429 Major Pharmaceuticals ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 0904-6375_bc099f91-611c-49e2-adab-011ac5062b23 0904-6375 HUMAN PRESCRIPTION DRUG Rabeprazole sodium Rabeprazole sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA202376 Major Pharmaceuticals RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 0904-6376_f43d574b-0715-403a-aa5c-cf206a28699f 0904-6376 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Major Pharmaceuticals OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 0904-6377_f43d574b-0715-403a-aa5c-cf206a28699f 0904-6377 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Major Pharmaceuticals OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 0904-6378_c98c3633-be15-47c7-a5eb-4c11ecf0b530 0904-6378 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED ORAL 20140609 ANDA ANDA075593 Major Pharmaceuticals CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0904-6389_2bf02524-4f4a-45fd-8ed9-e3e697457890 0904-6389 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20140609 ANDA ANDA090467 Major Pharmaceuticals LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0904-6390_2bf02524-4f4a-45fd-8ed9-e3e697457890 0904-6390 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20140609 ANDA ANDA090467 Major Pharmaceuticals LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0904-6391_2bf02524-4f4a-45fd-8ed9-e3e697457890 0904-6391 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20140609 ANDA ANDA090467 Major Pharmaceuticals LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0904-6398_2aa512e7-4833-4c09-b616-229559975828 0904-6398 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20140616 ANDA ANDA077380 Major Pharmaceuticals QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 0904-6406_43317a6e-01d0-4a5f-add8-3dedab149113 0904-6406 HUMAN PRESCRIPTION DRUG Moxifloxacin Moxifloxacin TABLET, FILM COATED ORAL 20140305 ANDA ANDA076938 Major Pharmaceuticals MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 0904-6408_229b49a4-5e10-46ed-9899-e16d9f822a36 0904-6408 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride 5 mg Donepezil Hydrochloride TABLET, FILM COATED ORAL 20140615 ANDA ANDA201724 Major Pharmaceuticals DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0904-6409_229b49a4-5e10-46ed-9899-e16d9f822a36 0904-6409 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride 10 mg Donepezil Hydrochloride TABLET, FILM COATED ORAL 20140615 ANDA ANDA201724 Major Pharmaceuticals DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 0904-6410_466b3f8c-37d6-45a3-ab59-96d2229e4ef9 0904-6410 HUMAN PRESCRIPTION DRUG Dehydrated Alcohol Dehydrated alcohol INJECTION INTRASPINAL 20140801 UNAPPROVED DRUG OTHER Major Pharmaceuticals ALCOHOL .98 mL/mL 0904-6412_2ba0eeb2-7048-4259-83d5-9f4ec1c92d32 0904-6412 HUMAN OTC DRUG Major Regular Strength Assorted Flavors Antacid Tablets TABLET, CHEWABLE ORAL 20140812 OTC MONOGRAPH FINAL part331 Major Pharmaceuticals CALCIUM CARBONATE 500 mg/1 0904-6414_b5f0a934-05b7-4deb-a6c6-907e1a34d447 0904-6414 HUMAN PRESCRIPTION DRUG Potrassium Chloride Potassium Chloride SOLUTION ORAL 20140723 UNAPPROVED DRUG OTHER Major Pharmaceuticals POTASSIUM CHLORIDE 40 meq/30mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 0904-6418_6a5a8ee8-f037-43b8-ad6b-200d3a83eeec 0904-6418 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20141001 ANDA ANDA076533 Major Pharmaceuticals TIZANIDINE HYDROCHLORIDE 4.576 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 0904-6426_0fb790e0-0091-4da2-9026-d70932bbac15 0904-6426 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20141015 ANDA ANDA090939 Major Pharmaceuticals ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-6427_0fb790e0-0091-4da2-9026-d70932bbac15 0904-6427 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20141015 ANDA ANDA090939 Major Pharmaceuticals ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 0904-7623_03559ee0-5323-4d7c-9709-3200bcf68040 0904-7623 HUMAN OTC DRUG Hydrocortisone Maximum Strength with Aloe Hydrocortisone CREAM TOPICAL 20090421 OTC MONOGRAPH NOT FINAL part348 Major Pharmaceuticals HYDROCORTISONE 1 g/100g 0904-7651_d78bc39f-f6d9-4cfe-855e-8c27b0776742 0904-7651 HUMAN OTC DRUG Extra Strength Mapap PM ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20110504 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 0904-7688_c0f4c501-0b9a-42d5-9b6e-2350f2257bc1 0904-7688 HUMAN OTC DRUG Anu-Med Phenylephrine Hydrochloride and Fat, Hard SUPPOSITORY RECTAL 19960401 UNAPPROVED DRUG OTHER Major Pharmaceuticals FAT, HARD; PHENYLEPHRINE HYDROCHLORIDE 1.77; 5 g/1; mg/1 0904-7695_49d434f2-0a54-41d9-b87d-231e5b3dd0f3 0904-7695 HUMAN OTC DRUG antacid extra strength Calcium carbonate TABLET, CHEWABLE ORAL 19940502 OTC MONOGRAPH FINAL part331 Major Pharmaceuticals CALCIUM CARBONATE 750 mg/1 0904-7704_96a92311-4c76-454e-b98a-39a331a38bad 0904-7704 HUMAN OTC DRUG Aspir Low Aspirin TABLET ORAL 20110524 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals ASPIRIN 81 mg/1 0904-7718_83d65fd9-8ac2-48de-8167-bd315f65a329 0904-7718 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20110519 ANDA ANDA073618 Major Pharmaceuticals CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0904-7719_83d65fd9-8ac2-48de-8167-bd315f65a329 0904-7719 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20110519 ANDA ANDA073589 Major Pharmaceuticals CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0904-7720_83d65fd9-8ac2-48de-8167-bd315f65a329 0904-7720 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20110519 ANDA ANDA073607 Major Pharmaceuticals CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 0904-7725_be8f1c7d-fd4e-48d4-80b0-1d92a2ba6a70 0904-7725 HUMAN OTC DRUG anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030224 ANDA ANDA075232 Major Pharmaceuticals LOPERAMIDE HYDROCHLORIDE 2 mg/1 0904-7727_c146d7c7-2c9a-4a20-abd2-8f3267980b2c 0904-7727 HUMAN OTC DRUG ACID GONE ANTACID aluminum hydroxide and magnesium carbonate LIQUID ORAL 20041230 OTC MONOGRAPH FINAL part331 Major Pharmaceuticals ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 95; 358 mg/15mL; mg/15mL 0904-7734_a68f32c5-c9ae-4c48-bf5b-4354b927508f 0904-7734 HUMAN OTC DRUG Miconazole 7 Miconazole nitrate CREAM VAGINAL 20090421 ANDA ANDA074164 Major MICONAZOLE NITRATE 2 g/100g 0904-7760_e3581de3-4f4a-42d6-92da-ef7a8506907b 0904-7760 HUMAN OTC DRUG Clear Anti Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 19950418 OTC MONOGRAPH FINAL part347 Major Pharmaceuticals PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL 0904-7809_a0c911a2-1272-438d-b8f9-37408d206056 0904-7809 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 19880229 ANDA ANDA071611 Major Pharmaceuticals CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 0904-7822_6367cfe3-f896-4a3a-8f15-e0a081522419 0904-7822 HUMAN OTC DRUG Major Clotrimazole CLOTRIMAZOLE CREAM TOPICAL 20041004 OTC MONOGRAPH FINAL part333C Major Pharmaceuticals CLOTRIMAZOLE 10 mg/g 0904-7889_4c709dfd-49c7-419c-93ce-0a069aba1bba 0904-7889 HUMAN OTC DRUG MAJOR DOK Docusate Sodium DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100423 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE SODIUM 100 mg/1 0904-7891_8629c164-ed24-4a91-967f-f9c761f59ccc 0904-7891 HUMAN OTC DRUG DOK EXTRA STRENGTH STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20020827 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE SODIUM 250 mg/1 0904-7912_9468fef9-235a-4d85-9af3-cadd138a18ce 0904-7912 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 19940816 ANDA ANDA072096 Major Pharmaceuticals IBUPROFEN 200 mg/1 0904-7914_52463cd9-771e-4e1e-95dc-e1808d4dd69c 0904-7914 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 20071106 ANDA ANDA075139 Major Pharmaceuticals IBUPROFEN 200 mg/1 0904-7915_403304eb-4f41-40d0-a664-fa7afbe5946f 0904-7915 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals IBUPROFEN 200 mg/1 0904-7927_fb1b1f1a-49ad-47e7-b170-e20ca8e4aeb9 0904-7927 HUMAN OTC DRUG Bisacodyl Enteric Coated Bisacodyl TABLET, COATED ORAL 20081024 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals BISACODYL 5 mg/1 0904-7938_96122457-2d6f-4206-9eb2-e68c98b83f6a 0904-7938 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate, and Dexamethasone OINTMENT OPHTHALMIC 19940725 ANDA ANDA064063 Major Pharmaceuticals DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0904-7948_352162a3-03dc-4297-ae34-a334d21541ec 0904-7948 HUMAN OTC DRUG Effervescent Pain Relief Fast Relief Fast Relief Aspirin, Citric Acid Anhydrous, and Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 19960426 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 0904-7955_5841a110-0de2-4361-a4db-91f751cd9d35 0904-7955 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19921121 OTC MONOGRAPH FINAL part340 Major Pharmaceuticals CAFFEINE 200 mg/1 0924-0011_915b4e91-de53-4701-ab54-ebd3ec5a216e 0924-0011 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20140708 OTC MONOGRAPH NOT FINAL part333A Acme United Corporation ISOPROPYL ALCOHOL .7 mL/mL 0924-0014_6c9c094f-19b3-4930-ae56-b31b7681c701 0924-0014 HUMAN OTC DRUG Pac-Kit Motion Sickness Dimenhydrinate TABLET, COATED ORAL 20131021 OTC MONOGRAPH FINAL part336 Acme United Corporation DIMENHYDRINATE 50 mg/1 0924-0074_85afb49b-1b2b-4917-97c5-21f2597d817b 0924-0074 HUMAN OTC DRUG PhysiciansCare Ibuprofen Ibuprofen TABLET ORAL 20111007 ANDA ANDA075139 Acme United Corporation IBUPROFEN 200 mg/1 0924-0086_5554956b-998c-4215-b3e2-6272d2c776bf 0924-0086 HUMAN OTC DRUG PhysiciansCare Antacid CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20111128 OTC MONOGRAPH FINAL part331 Acme United Corporation CALCIUM CARBONATE 420 mg/1 0924-0087_3f5a4acd-cfaf-46ee-bd1d-5d9ba45a560d 0924-0087 HUMAN OTC DRUG PhysiciansCare Antacid CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20120118 OTC MONOGRAPH FINAL part331 Acme United Corporation CALCIUM CARBONATE 420 mg/1 0924-0091_4554f4f5-d91c-47ea-8d3d-1e76befd7e8a 0924-0091 HUMAN OTC DRUG PhysiciansCare Allergy Multi-Symptom Relief Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20111223 OTC MONOGRAPH FINAL part341 Acme United Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 0924-0123_356b0db2-2c37-48dd-a5ba-a5e3f90c395d 0924-0123 HUMAN OTC DRUG PhysiciansCare Non Aspirin Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20120120 OTC MONOGRAPH NOT FINAL part343 Acme United Corporation ACETAMINOPHEN 500 mg/1 0924-0128_d74c2e9e-1a85-4b4c-9462-c5b6470fb054 0924-0128 HUMAN OTC DRUG PhysiciansCare Non Aspirin Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20120120 OTC MONOGRAPH NOT FINAL part343 Acme United Corporation ACETAMINOPHEN 500 mg/1 0924-0133_14f52682-299a-4dac-8436-d3917089c926 0924-0133 HUMAN OTC DRUG PhysiciansCare Sinus Non-Drowsy Phenylephrine HCL TABLET, FILM COATED ORAL 20120129 OTC MONOGRAPH FINAL part341 Acme United Corporation PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 0924-0137_6ae23fa9-4b33-45b6-a95b-6887a065870f 0924-0137 HUMAN OTC DRUG PhysiciansCare Cold and Cough Non-Drowsy Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20120128 OTC MONOGRAPH FINAL part341 Acme United Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 0924-0140_1f70d8f3-7c80-4262-81af-0fe6ee2b3384 0924-0140 HUMAN OTC DRUG PhysiciansCare Cold and Cough Non-Drowsy Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20120128 OTC MONOGRAPH FINAL part341 Acme United Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 0924-0160_c55a1e12-9562-4af6-9fbc-152e2a0e8e03 0924-0160 HUMAN OTC DRUG PhysiciansCare Ophthalmic Solution Eyewash Purified Water 98.3% SOLUTION OPHTHALMIC 20130624 NDA NDA022305 Acme United Corporation WATER 929 g/946mL 0924-0162_41a6cb62-68f6-4cad-92f4-236fa573dfcf 0924-0162 HUMAN OTC DRUG PhysiciansCare Ophthalmic Solution Eyewash Purified Water 98.3% SOLUTION OPHTHALMIC 20130624 NDA NDA022305 Acme United Corporation WATER 929 g/946mL 0924-0164_20648d16-647f-4597-8d08-9f5b1cbf9641 0924-0164 HUMAN OTC DRUG PhysiciansCare Ophthalmic Solution Eyewash Purified Water 98.3% SOLUTION OPHTHALMIC 20130624 NDA NDA022305 Acme United Corporation WATER 929 g/946mL 0924-0166_41db9460-d295-4d6c-b8c7-80e5f12c656e 0924-0166 HUMAN OTC DRUG PhysiciansCare Ophthalmic Solution Eyewash Purified Water 98.3% SOLUTION OPHTHALMIC 20140124 NDA NDA022305 Acme United Corporation WATER 929 g/946mL 0924-0930_8ea9e84f-8ed0-4ccf-91b1-6be00f04c3eb 0924-0930 HUMAN OTC DRUG Burn Lidocaine Hydrochloride SPRAY TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part348 Acme United Corp LIDOCAINE HYDROCHLORIDE 20 mg/L 0924-0931_5c7f6934-e18b-405b-a20a-de4ad985fe35 0924-0931 HUMAN OTC DRUG Antiseptic First Aid benzalkonium chloride and benzocaine SPRAY TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part333A Acme United Corp BENZALKONIUM CHLORIDE; BENZOCAINE 1; 50 mg/g; mg/g 0924-0932_e254bb4b-3956-48d3-af71-618339e750e8 0924-0932 HUMAN OTC DRUG Hydrogen Peroxide Antiseptic Hydrogen Peroxide SPRAY TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part333A Acme United Corp HYDROGEN PEROXIDE 30 mL/L 0924-0933_82157aa5-4ebe-445f-a2ac-46a10778ecf4 0924-0933 HUMAN OTC DRUG Isopropyl Alcohol Antiseptic Isopropyl Alcohol SPRAY TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part333A Acme United Corp ISOPROPYL ALCOHOL 700 mL/L 0924-1006_3568bc0f-c8c4-4bee-a5ef-27fc4bfa4784 0924-1006 HUMAN OTC DRUG PhysiciansCare Dimenhydrinate Motion Sickness Relief Dimenhydrinate TABLET, COATED ORAL 20131005 OTC MONOGRAPH FINAL part336 Acme United Corporation DIMENHYDRINATE 50 mg/1 0924-1805_3b31e3d8-a8aa-4329-8a06-3292db39dfca 0924-1805 HUMAN OTC DRUG ACME Small Cuts and Burns BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE KIT 20100430 OTC MONOGRAPH FINAL part333 Acme United Corp. 0924-1806_9f71f835-9965-4409-9cbe-44b04a0b0022 0924-1806 HUMAN OTC DRUG ACME FIRST AID Contains 404 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN, BENZOCAINE, ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE KIT 20100427 OTC MONOGRAPH FINAL part333 Acme United Corp. 0924-1807_bbe4198a-e8fb-4d98-b197-0dbeee82e056 0924-1807 HUMAN OTC DRUG BLUE ACME SLEEVE FIRST AID Contains 1000 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, BENZALKONIUM CHLORIDE, WATER, ISOPROPYL ALCOHOL, ASPIRIN, BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE KIT 20100427 OTC MONOGRAPH FINAL part333 Acme United Corp. 0924-5000_2305a8eb-39c9-4320-9b43-9c05ccb3fb65 0924-5000 HUMAN OTC DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride GEL TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part348 Acme United Corporation LIDOCAINE HYDROCHLORIDE 20 mg/g 0924-5200_e8381540-e7a1-4db2-947e-601ced32c4a3 0924-5200 HUMAN OTC DRUG Antiseptic alcohol, lidocaine hydrochloride LIQUID TOPICAL 20120306 OTC MONOGRAPH NOT FINAL part333E Acme United Corporation ALCOHOL; LIDOCAINE HYDROCHLORIDE 500; 20 mg/g; mg/g 0924-5603_29d034b8-1c10-4319-894e-67abf6507cb8 0924-5603 HUMAN OTC DRUG triple antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20120127 OTC MONOGRAPH FINAL part333B Acme United Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 0924-5603_589803b1-7e58-4e60-9ac5-b17fe07d0474 0924-5603 HUMAN OTC DRUG triple antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Acme United Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 0924-5603_b8f41aa9-9580-45e9-b9cb-de1240f5471d 0924-5603 HUMAN OTC DRUG triple antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Acme United Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 0924-5701_3a6943c0-276c-4e76-a2a8-948163263d18 0924-5701 HUMAN OTC DRUG First Aid and Burn Benzalkonium Chloride, Lidocaine Hydrochloride CREAM TOPICAL 20120127 OTC MONOGRAPH NOT FINAL part333A Acme United Corporation BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g 0924-5701_847a8aff-6b66-427d-8bd6-e268dcc4feaf 0924-5701 HUMAN OTC DRUG First Aid and Burn Benzalkonium Chloride, Lidocaine Hydrochloride CREAM TOPICAL 20120127 OTC MONOGRAPH NOT FINAL part333A Acme United Corporation BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g 0924-5701_f71543e8-a6fb-4d21-9e89-f77005322002 0924-5701 HUMAN OTC DRUG First Aid and Burn Benzalkonium Chloride, Lidocaine Hydrochloride CREAM TOPICAL 20120127 OTC MONOGRAPH NOT FINAL part333A Acme United Corporation BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g 0924-7110_c6468ea2-775a-442d-8c88-ed3dd9843471 0924-7110 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20120320 OTC MONOGRAPH NOT FINAL part333E Acme United Corporation BENZALKONIUM CHLORIDE 1.2478 g/L 0941-0409_3cbff926-5ff1-42a5-b5a9-f711fbb57ef9 0941-0409 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.3; 1.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0941-0411_3cbff926-5ff1-42a5-b5a9-f711fbb57ef9 0941-0411 HUMAN PRESCRIPTION DRUG DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 1.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0941-0413_3cbff926-5ff1-42a5-b5a9-f711fbb57ef9 0941-0413 HUMAN PRESCRIPTION DRUG DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 2.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0941-0415_3cbff926-5ff1-42a5-b5a9-f711fbb57ef9 0941-0415 HUMAN PRESCRIPTION DRUG DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 4.25; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0941-0424_3cbff926-5ff1-42a5-b5a9-f711fbb57ef9 0941-0424 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19921204 NDA NDA020183 Baxter Healthcare Corporation CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.3; 1.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0941-0426_3cbff926-5ff1-42a5-b5a9-f711fbb57ef9 0941-0426 HUMAN PRESCRIPTION DRUG DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19921204 NDA NDA020163 Baxter Healthcare Corporation CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 1.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0941-0427_3cbff926-5ff1-42a5-b5a9-f711fbb57ef9 0941-0427 HUMAN PRESCRIPTION DRUG DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19921204 NDA NDA020163 Baxter Healthcare Corporation CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 2.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0941-0429_3cbff926-5ff1-42a5-b5a9-f711fbb57ef9 0941-0429 HUMAN PRESCRIPTION DRUG DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19921204 NDA NDA020163 Baxter Healthcare Corporation CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 4.25; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0941-0430_3cbff926-5ff1-42a5-b5a9-f711fbb57ef9 0941-0430 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19921204 NDA NDA020183 Baxter Healthcare Corporation CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.3; 2.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0941-0433_3cbff926-5ff1-42a5-b5a9-f711fbb57ef9 0941-0433 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19921204 NDA NDA020183 Baxter Healthcare Corporation CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.3; 4.25; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0941-0457_3cbff926-5ff1-42a5-b5a9-f711fbb57ef9 0941-0457 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.3; 2.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0941-0459_3cbff926-5ff1-42a5-b5a9-f711fbb57ef9 0941-0459 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.3; 4.25; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0941-0464_88728f52-a9ba-497c-b8c6-889f6bb35fe7 0941-0464 HUMAN PRESCRIPTION DRUG DIANEAL FOR PERITONEAL DIALYSIS anhydrouse dextrose, sodium chloride, sodium lactate, calcium chloride, magnesium chloride INJECTION, SOLUTION INTRAPERITONEAL 20141027 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation ANHYDROUS DEXTROSE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 13.6; .184; .051; 5.38; 4.48 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0941-0465_88728f52-a9ba-497c-b8c6-889f6bb35fe7 0941-0465 HUMAN PRESCRIPTION DRUG DIANEAL FOR PERITONEAL DIALYSIS anhydrous dextrose, sodium chloride, sodium lactate, calcium chloride, magnesium chloride INJECTION, SOLUTION INTRAPERITONEAL 20141027 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation ANHYDROUS DEXTROSE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 22.7; .184; .051; 5.38; 4.48 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0941-0466_88728f52-a9ba-497c-b8c6-889f6bb35fe7 0941-0466 HUMAN PRESCRIPTION DRUG DIANEAL FOR PERITONEAL DIALYSIS anhydrous dextrose, sodium chloride, sodium lactate, calcium chloride, magnesium chloride INJECTION, SOLUTION INTRAPERITONEAL 20141027 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation ANHYDROUS DEXTROSE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 38.6; .184; .051; 5.38; 4.48 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0941-0679_725084aa-104b-496a-b021-c22f811011e8 0941-0679 HUMAN PRESCRIPTION DRUG EXTRANEAL icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride INJECTION, SOLUTION INTRAPERITONEAL 20021220 NDA NDA021321 Baxter Healthcare Corporation CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 7.5; 5.08; 535; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 0942-0641_1f546c80-456a-4fd7-984a-902a0a4305f6 0942-0641 HUMAN PRESCRIPTION DRUG ACD-A Anticoagulant Citrate Dextrose Solution Formula A SOLUTION INTRAVENOUS 20070301 NDA BN160918 Fenwal Inc ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM CITRATE 7.3; 24.5; 22 g/1000mL; g/1000mL; g/1000mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-0641_35ba5cb0-f707-4b7d-bb85-0ebc46ba0a5e 0942-0641 HUMAN PRESCRIPTION DRUG ACD-A Anticoagulant Citrate Dextrose Solution Formula A SOLUTION INTRAVENOUS 20070301 NDA BN160918 Fenwal Inc ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM CITRATE 3.65; 12.25; 11 g/500mL; g/500mL; g/500mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6301_b702ab32-f32a-46fd-81d5-04280102a994 0942-6301 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 19.3; 209; 2.23; 155; 1.84 mg/70mL; mg/70mL; g/70mL; mg/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6305_bb15753f-ec9d-4fa5-b63b-7d3b429ba031 0942-6305 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 17.3; 188; 2; 140; 1.66 mg/63mL; mg/63mL; g/63mL; mg/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6307_2b4d29fd-6ed3-47d8-b63b-18d960f6d274 0942-6307 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 19.3; 209; 2.23; 155; 1.84 mg/70mL; mg/70mL; g/70mL; mg/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6308_7b79aac0-9151-4559-beac-b30bbff5de1b 0942-6308 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 19.3; 209; 2.23; 155; 1.84 mg/70mL; mg/70mL; g/70mL; mg/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6309_29199a9b-0778-4344-ac42-690ac41fc3dd 0942-6309 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 17.3; 188; 2; 140; 1.66 mg/63mL; mg/63mL; g/63mL; mg/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6312_7664c2b2-9088-414c-93b8-28924a076a9a 0942-6312 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 19.3; 209; 2.23; 155; 1.84 mg/70mL; mg/70mL; g/70mL; mg/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6316_44716649-800d-4404-b6fa-7ec9981f3cbf 0942-6316 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070620 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 19.3; 209; 2.23; 155; 1.84 mg/70mL; mg/70mL; g/70mL; mg/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6317_78c745fb-0230-4c14-9b58-6c22b97e7a7a 0942-6317 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 17.3; 188; 2; 140; 1.66 mg/63mL; mg/63mL; g/63mL; mg/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6319_c57c487a-57cf-4366-a4a8-0674ea5b1717 0942-6319 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 17.3; 188; 2; 140; 1.66 mg/63mL; mg/63mL; g/63mL; mg/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6320_cf77e2c0-343e-4a1e-9479-f90bf3246707 0942-6320 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070604 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 19.3; 209; 2.23; 155; 1.84 mg/70mL; mg/70mL; g/70mL; mg/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6321_41e6b368-ce10-4a6b-a25c-42ce690b0eb0 0942-6321 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070601 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 9.6; 105; 1.12; 78; 921 mg/35mL; mg/35mL; g/35mL; mg/35mL; mg/35mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6322_c225c6cc-620c-43c1-8ad2-777c82aacd87 0942-6322 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070624 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 17.3; 188; 2; 140; 1.66 mg/63mL; mg/63mL; g/63mL; mg/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6326_dfb7c531-0785-4adf-a6aa-c8872b9e8ad9 0942-6326 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20081215 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 19.3; 209; 2.23; 155; 1.84 mg/70mL; mg/70mL; g/70mL; mg/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6327_d3367c79-636e-4386-933e-440ab2d74378 0942-6327 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20100517 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 17.3; 188; 2; 140; 1.66 mg/63mL; mg/63mL; g/63mL; mg/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6328_b673b012-03f7-4da2-b81b-596b828df0bd 0942-6328 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20100525 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 13.5; 147; 1.56; 109; 1.29 mg/49mL; mg/49mL; g/49mL; mg/49mL; g/49mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6329_5a9b3a98-86e3-487f-8c3a-cff931ac5bf7 0942-6329 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20100525 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 13.5; 147; 1.56; 109; 1.29 mg/49mL; mg/49mL; g/49mL; mg/49mL; g/49mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6330_a62e19c3-f02b-4e27-9778-77431dd40a5c 0942-6330 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20100525 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 17.3; 188; 2; 140; 1.66 mg/63mL; mg/63mL; g/63mL; mg/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6331_6dd6db7b-c92c-4a7c-89e1-af9ec514e4f8 0942-6331 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20100525 NDA BN770420 Fenwal, Inc. ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 13.5; 160; 1.56; 109; 1.29 mg/49mL; mg/49mL; g/49mL; mg/49mL; g/49mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6332_8fed2b42-6fe4-4119-84bf-6bd944c3e174 0942-6332 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20100621 NDA BN770420 Fenwal, Inc. ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 13.5; 160; 1.56; 109; 1.29 mg/49mL; mg/49mL; g/49mL; mg/49mL; g/49mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6336_32795354-94c1-4d58-a2c9-7d863f3a42ee 0942-6336 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20100621 NDA BN770420 Fenwal, Inc. ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 17.3; 206; 2.01; 140; 1.66 mg/63mL; mg/63mL; g/63mL; mg/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6343_eeccc690-f8b2-4466-aa12-084e339e91e9 0942-6343 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20100819 NDA BN770420 Fenwal, Inc. ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 17.3; 206; 2.01; 140; 1.66 mg/63mL; mg/63mL; g/63mL; mg/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6344_5b78ea45-7fff-4978-9a94-1dd1ae1699d9 0942-6344 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20121204 NDA BN770420 Fenwal, Inc. ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 17.3; 206; 2.01; 140; 1.66 mg/63mL; mg/63mL; g/63mL; mg/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-6430_cd3be06b-eb6d-4942-b2c2-315fa4058e11 0942-6430 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6431_839203f8-d96e-4f25-a295-766f368117d1 0942-6431 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6436_91c480ae-9f42-4f58-b06f-da6b95d189f5 0942-6436 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6439_d3789974-14dd-4b5d-93a8-444ec2358a88 0942-6439 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6444_2df5ff68-5ed7-4578-8852-f0016318a1db 0942-6444 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6445_d34e2f5a-48ce-416b-8267-bfdb5f02af28 0942-6445 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6449_b2c36152-4942-42e6-b404-e4675e11882c 0942-6449 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6453_20d8ae2c-e075-4258-81c4-1da40ecdd7a1 0942-6453 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6457_fd6894fd-7522-4bfa-b2bc-9b1af4efbbc4 0942-6457 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6458_c9be865c-0e28-44a3-a666-9f8b6c71a4d2 0942-6458 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6459_f3ff7291-f1a6-4fb4-a122-4d724a8daae5 0942-6459 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6461_33585755-27e9-467b-867c-5e56938ad0a2 0942-6461 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6462_c0c6647a-351f-40e3-b236-68eb4c3fb77e 0942-6462 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6464_09dc1b38-828d-42e1-8ee7-2f2268a93e60 0942-6464 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6466_0ca1dfd7-8b95-4ddd-a675-fd1006290369 0942-6466 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6470_ea24df0e-4e26-4f08-9c8e-282863b9d2a3 0942-6470 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6475_8263b939-c2f9-421f-adbd-72d1cb51c368 0942-6475 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. 0942-6476_77135eb2-a981-409d-a019-b1a7e12846b3 0942-6476 HUMAN PRESCRIPTION DRUG CPD/ADSOL Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20071001 NDA BN811104 Fenwal, Inc. 0942-6477_0b4d6e7d-be79-46f6-8ab1-ffbd4ec87951 0942-6477 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20071001 NDA BN811104 Fenwal, Inc. 0942-6478_ff4ecfbc-eec7-4940-ba47-214d6248e5fc 0942-6478 HUMAN PRESCRIPTION DRUG CPD/ADSOL Red Cell Preservation Solution System (PL 2209) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20080131 NDA BN900223 Fenwal, Inc. 0942-6479_fc791891-11a8-45ab-9c7b-44fc43bb0c2d 0942-6479 HUMAN PRESCRIPTION DRUG CPD/ADSOL Red Cell Preservation Solution System (PL 2209) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20080131 NDA BN900223 Fenwal, Inc. 0942-6481_4c43203c-7cec-4dfc-bf43-a0a8d958de28 0942-6481 HUMAN PRESCRIPTION DRUG CPD/ADSOL Red Cell Preservation Solution System (PL 2209) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20080201 NDA BN900223 Fenwal, Inc. 0942-6482_d9b89fdf-0cdc-49a1-9eeb-0848750e4ac5 0942-6482 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070611 NDA BN811104 Fenwal, Inc. 0942-6483_5c032f20-266e-4c2c-bfd5-f9b1ed1d7ece 0942-6483 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20080210 NDA BN811104 Fenwal, Inc. 0942-6484_3da271c8-622f-42aa-a2cf-2b00223a5279 0942-6484 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070606 NDA BN811104 Fenwal, Inc. 0942-6485_2ba48b17-3344-44bf-a44b-6a8026387ac1 0942-6485 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070606 NDA BN811104 Fenwal, Inc. 0942-6486_7a894247-b4da-4fd7-88c1-18d397ed6265 0942-6486 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070501 NDA BN811104 Fenwal, Inc. 0942-6487_698a0a7c-93c7-428e-8ba9-0e063c9099ba 0942-6487 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070606 NDA BN811104 Fenwal, Inc. 0942-6488_1b16d05f-7318-410a-9fcf-5c171e5bae92 0942-6488 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070604 NDA BN811104 Fenwal, Inc. 0942-6489_e018a5fd-77a9-426c-8aba-c45c00237323 0942-6489 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070604 NDA BN811104 Fenwal, Inc. 0942-6492_639c54e4-313b-4027-8c83-b40558b221ee 0942-6492 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20090515 NDA BN811104 Fenwal, Inc. 0942-6493_c6da1be0-f33f-4d03-a055-34b7bd4d68b8 0942-6493 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20090515 NDA BN811104 Fenwal, Inc. 0942-6494_f7d4932d-4267-441f-b8dc-992620eeacd4 0942-6494 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20100525 NDA BN811104 Fenwal, Inc. 0942-6495_e3030250-8359-49f3-8048-6708924b5958 0942-6495 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20100525 NDA BN811104 Fenwal, Inc. 0942-6496_148024cd-1131-447e-8c77-afa887fe1446 0942-6496 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20100621 NDA BN811104 Fenwal, Inc. 0942-6499_f5e14917-85c8-4de7-aff1-9263044d10af 0942-6499 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20100928 NDA BN811104 Fenwal, Inc. 0942-6501_248a7ecc-47e9-406b-9e16-35118c062cbb 0942-6501 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20110304 NDA BN811104 Fenwal, Inc. 0942-6502_eb50456b-336d-4c24-85f4-3e1d86336add 0942-6502 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20110111 NDA BN811104 Fenwal, Inc. 0942-6503_50b163ad-1bdf-4f3c-990b-2c45131845f0 0942-6503 HUMAN PRESCRIPTION DRUG CPD/ADSOL Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20130213 NDA BN811104 Fenwal, Inc. 0942-9001_8a8c6bd9-c20b-4960-9314-7c9be34605c7 0942-9001 HUMAN PRESCRIPTION DRUG ACD Blood-Pack Units (PL 146 Plastic) Anticoagulant Citrate Dextrose (ACD) SOLUTION INTRAVENOUS 20070301 NDA BN160918 Fenwal, Inc. ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 493; 1.65; 1.48 mg/67.5mL; g/67.5mL; g/67.5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-9005_bf4444ef-bff1-46c8-b11d-99091f14262d 0942-9005 HUMAN PRESCRIPTION DRUG ACD-A Antiocoagulant Citrate Dextrose Solution, Formula A SOLUTION INTRAVENOUS 20121024 NDA BN160918 Fenwal Inc. ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM CITRATE 730; 2.45; 2.2 mg/100mL; g/100mL; g/100mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-9201_d1a26b01-7b75-4adb-b72c-9eff5976324a 0942-9201 HUMAN PRESCRIPTION DRUG Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic Anticoagulant Citrate Phosphate Dextrose (CPD) Solution SOLUTION INTRAVENOUS 20070301 NDA BN170401 Fenwal, Inc. ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 105; 893; 78; 921 mg/35mL; mg/35mL; mg/35mL; mg/35mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-9202_3875335e-b6f8-4d53-98bf-e9c3b09f56d9 0942-9202 HUMAN PRESCRIPTION DRUG Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic Anticoagulant Citrate Phosphate Dextrose (CPD) SOLUTION INTRAVENOUS 20070331 NDA BN170401 Fenwal, Inc. ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 188; 1.61; 140; 1.66 mg/63mL; g/63mL; mg/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-9206_78fada3f-c891-4ffa-b78b-3cb9b83595ca 0942-9206 HUMAN PRESCRIPTION DRUG CPD Anticoagulant Citrate Phosphate Dextrose (CPD) SOLUTION INTRAVENOUS 20070301 NDA BN170401 Fenwal, Inc. ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 188; 1.61; 140; 1.66 mg/63mL; g/63mL; mg/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-9304_895c186e-a6c3-4a0e-b5a8-f373ae0ca6b4 0942-9304 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 17.3; 188; 2; 140; 1.66 mg/63mL; mg/63mL; g/63mL; mg/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-9393_429b6520-df50-4ba8-8051-8ae84f929f9a 0942-9393 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 19.3; 209; 2.23; 155; 1.84 mg/70mL; mg/70mL; g/70mL; mg/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-9394_40490799-1495-4496-b770-ad4ab5cc4874 0942-9394 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) Solution SOLUTION INTRAVENOUS 20070301 NDA BN077420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 17.3; 188; 2; 140; 1.66 mg/63mL; mg/63mL; g/63mL; mg/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-9395_8836720c-9b27-4cc7-a25f-9f7e69258dd3 0942-9395 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 19.3; 209; 2.23; 155; 1.84 mg/70mL; mg/70mL; g/70mL; mg/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-9398_18724dde-3988-4f3f-8df6-2e00478c4089 0942-9398 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 17.3; 188; 2; 140; 1.66 mg/63mL; mg/63mL; g/63mL; mg/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-9502_b1211b76-47e8-4d6f-bbcd-d63327328977 0942-9502 HUMAN PRESCRIPTION DRUG Sodium Citrate Blood-Pack Units, (PL 146 Plastic) Anticoagulant Sodium Citrate Solution SOLUTION INTRAVENOUS 20070301 NDA BN770923 Fenwal, Inc. TRISODIUM CITRATE DIHYDRATE 2 g/50mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-9504_578a66d5-9489-497e-953e-66d9ed7d991b 0942-9504 HUMAN PRESCRIPTION DRUG Sodium Citrate Blood-Pack Units, (PL 146 Plastic) Anticoagulant Sodium Citrate Solution SOLUTION INTRAVENOUS 20070301 NDA BN770923 Fenwal, Inc. TRISODIUM CITRATE DIHYDRATE 4 g/100mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-9505_2376bc6e-1255-474f-a5cd-0dd934ecd50b 0942-9505 HUMAN PRESCRIPTION DRUG Sodium Citrate Blood-Pack Units, (PL 146 Plastic) Anticoagulant Sodium Citrate Solution SOLUTION INTRAVENOUS 20070301 NDA BN770923 Fenwal, Inc. TRISODIUM CITRATE DIHYDRATE 4 g/100mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0942-9601_2b22acc5-97e6-40bf-8165-4d1251d622e9 0942-9601 HUMAN PRESCRIPTION DRUG InterSol Platelet Additive 3 SOLUTION INTRAVENOUS 20121025 NDA BN080041 Fenwal, Inc. SODIUM ACETATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 442; 452; 305; 93; 318 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 0944-0490_584b129c-2312-4e20-8eec-9c0827925a10 0944-0490 PLASMA DERIVATIVE Buminate Albumin Human INJECTION, SOLUTION INTRAVENOUS 19540317 BLA BLA101452 Baxter Healthcare Corporation ALBUMIN HUMAN .25 g/mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 0944-0491_e4d971e5-4574-4358-b9a2-f10ef1d49079 0944-0491 PLASMA DERIVATIVE BUMINATE Albumin Human INJECTION, SOLUTION INTRAVENOUS 19550616 BLA BLA101452 Baxter Healthcare Corporation ALBUMIN HUMAN .05 g/mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 0944-0493_4a411444-5e2e-4f69-9458-1a78950d6f2c 0944-0493 PLASMA DERIVATIVE FLEXBUMIN Albumin Human SOLUTION INTRAVENOUS 20020809 BLA BLA101452 Baxter Healthcare Corporation ALBUMIN HUMAN .25 g/mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 0944-0495_79094f4e-5f5c-44d6-b563-d6078eafe83a 0944-0495 PLASMA DERIVATIVE Flexbumin Albumin Human INJECTION, SOLUTION INTRAVENOUS 20140731 BLA BLA101452 Baxter Healthcare Corporation ALBUMIN HUMAN .05 g/mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 0944-2510_7ca2c26f-4be2-48cd-be5b-486e350654ba 0944-2510 PLASMA DERIVATIVE HYQVIA HUMAN IMMUNEGLOBULIN G and HYALURONIDASE (HUMAN RECOMBINANT) KIT 20140912 BLA BLA125402 Baxter Healthcare Corporation 0944-2511_7ca2c26f-4be2-48cd-be5b-486e350654ba 0944-2511 PLASMA DERIVATIVE HyQvia HUMAN IMMUNEGLOBULIN G and HYALURONIDASE (HUMAN RECOMBINANT) KIT 20140912 BLA BLA125402 Baxter Healthcare Corporation 0944-2512_7ca2c26f-4be2-48cd-be5b-486e350654ba 0944-2512 PLASMA DERIVATIVE HyQvia HUMAN IMMUNEGLOBULIN G and HYALURONIDASE (HUMAN RECOMBINANT) KIT 20140912 BLA BLA125402 Baxter Healthcare Corporation 0944-2513_7ca2c26f-4be2-48cd-be5b-486e350654ba 0944-2513 PLASMA DERIVATIVE HyQvia HUMAN IMMUNEGLOBULIN G and HYALURONIDASE (HUMAN RECOMBINANT) KIT 20140912 BLA BLA125402 Baxter Healthcare Corporation 0944-2514_7ca2c26f-4be2-48cd-be5b-486e350654ba 0944-2514 PLASMA DERIVATIVE HyQvia HUMAN IMMUNEGLOBULIN G and HYALURONIDASE (HUMAN RECOMBINANT) KIT 20140912 BLA BLA125402 Baxter Healthcare Corporation 0944-2620_2046ae55-1613-427f-9e0f-d677b8cf8fd5 0944-2620 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxter Healthcare Corporation 0944-2620_26d73f6e-25b7-42b4-bf2e-903bc4c9f2f7 0944-2620 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxter Healthcare Corporation 0944-2620_84bf3b45-f329-408d-a971-55c098f92cb0 0944-2620 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxter Healthcare Corporation 0944-2620_e9ffa954-ccf0-4cfd-93f8-ddf795c62b07 0944-2620 PLASMA DERIVATIVE GAMMAGARD S/D HUMAN IMMUNOGLOBULIN G KIT 20110103 BLA BLA103133 Baxter Healthcare Corporation 0944-2623_b178c06a-655b-4dc0-a0d0-a99278a1d014 0944-2623 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxter Healthcare Corporation 0944-2625_b178c06a-655b-4dc0-a0d0-a99278a1d014 0944-2625 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxter Healthcare Corporation 0944-2627_b178c06a-655b-4dc0-a0d0-a99278a1d014 0944-2627 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxter Healthcare Corporation 0944-2655_9ac2ccbf-1271-477c-9cc9-811838432506 0944-2655 PLASMA DERIVATIVE GAMMAGARD S/D HUMAN IMMUNOGLOBULIN G KIT 20110103 BLA BLA103133 Baxter Healthcare Corporation 0944-2655_ac8b6376-290c-43df-b560-c2182bf9b029 0944-2655 PLASMA DERIVATIVE GAMMAGARD S/D HUMAN IMMUNOGLOBULIN G KIT 20110103 BLA BLA103133 Baxter Healthcare Corporation 0944-2656_56452f6e-47f6-4b37-b68d-3619f33fe717 0944-2656 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxter Healthcare Corporation 0944-2658_56452f6e-47f6-4b37-b68d-3619f33fe717 0944-2658 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxter Healthcare Corporation 0944-2700_9552ae74-aaed-44f7-87c2-cdc94838a467 0944-2700 PLASMA DERIVATIVE GAMMAGARD LIQUID Human Immunoglobulin G INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20050427 BLA BLA125105 Baxter Healthcare Corporation HUMAN IMMUNOGLOBULIN G 100 mg/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 0944-2802_5028100a-7ded-4762-8a41-5a107b507481 0944-2802 HUMAN PRESCRIPTION DRUG Aralast NP alpha-1 proteinase inhibitor human KIT 20100419 BLA BLA125039 Baxter Healthcare Corporation 0944-2802_6edc2f5d-5169-440f-a1ec-da702fd2abfd 0944-2802 HUMAN PRESCRIPTION DRUG Aralast NP alpha-1 proteinase inhibitor human KIT 20100419 BLA BLA125039 Baxter Healthcare Corporation 0944-2812_a28d52ce-70b4-4d74-b78c-4964bbd884ab 0944-2812 HUMAN PRESCRIPTION DRUG Aralast NP alpha-1 proteinase inhibitor human KIT 20100901 BLA BLA125039 Baxter Healthcare Corporation 0944-2814_a9a5b46e-04da-41bd-bb5f-c4936b664fef 0944-2814 PLASMA DERIVATIVE Aralast NP ALPHA.1-PROTEINASE INHIBITOR HUMAN KIT 20021223 BLA BLA125039 Baxter Healthcare Corporation 0944-2815_a9a5b46e-04da-41bd-bb5f-c4936b664fef 0944-2815 PLASMA DERIVATIVE Aralast NP ALPHA.1-PROTEINASE INHIBITOR HUMAN KIT 20021223 BLA BLA125039 Baxter Healthcare Corporation 0944-2822_a28d52ce-70b4-4d74-b78c-4964bbd884ab 0944-2822 HUMAN PRESCRIPTION DRUG Aralast NP alpha-1 proteinase inhibitor human KIT 20100901 BLA BLA125039 Baxter Healthcare Corporation 0944-2831_6eb61ecd-d264-4163-ba11-26d4816062f3 0944-2831 HUMAN PRESCRIPTION DRUG Recombinate Antihemophilic Factor Recombinant KIT 20100208 BLA BLA103375 Baxter Healthcare Corporation 0944-2831_cf92d5c9-abd7-4d3d-95c8-687d966bd747 0944-2831 HUMAN PRESCRIPTION DRUG Recombinate Antihemophilic Factor Recombinant KIT 20100208 BLA BLA103375 Baxter Healthcare Corporation 0944-2832_6eb61ecd-d264-4163-ba11-26d4816062f3 0944-2832 HUMAN PRESCRIPTION DRUG Recombinate Antihemophilic Factor Recombinant KIT 20100208 BLA BLA103375 Baxter Healthcare Corporation 0944-2832_cf92d5c9-abd7-4d3d-95c8-687d966bd747 0944-2832 HUMAN PRESCRIPTION DRUG Recombinate Antihemophilic Factor Recombinant KIT 20100208 BLA BLA103375 Baxter Healthcare Corporation 0944-2833_6eb61ecd-d264-4163-ba11-26d4816062f3 0944-2833 HUMAN PRESCRIPTION DRUG Recombinate Antihemophilic Factor Recombinant KIT 20100208 BLA BLA103375 Baxter Healthcare Corporation 0944-2833_cf92d5c9-abd7-4d3d-95c8-687d966bd747 0944-2833 HUMAN PRESCRIPTION DRUG Recombinate Antihemophilic Factor Recombinant KIT 20100208 BLA BLA103375 Baxter Healthcare Corporation 0944-2841_4914a5e8-6861-4af7-b26a-33977dd32004 0944-2841 PLASMA DERIVATIVE RECOMBINATE antihemophilic factor recombinant KIT 19921210 BLA BLA103375 Baxter Healthcare Corporation 0944-2842_4914a5e8-6861-4af7-b26a-33977dd32004 0944-2842 PLASMA DERIVATIVE RECOMBINATE antihemophilic factor recombinant KIT 19921210 BLA BLA103375 Baxter Healthcare Corporation 0944-2843_4914a5e8-6861-4af7-b26a-33977dd32004 0944-2843 PLASMA DERIVATIVE RECOMBINATE antihemophilic factor recombinant KIT 19921210 BLA BLA103375 Baxter Healthcare Corporation 0944-2844_4914a5e8-6861-4af7-b26a-33977dd32004 0944-2844 PLASMA DERIVATIVE RECOMBINATE antihemophilic factor recombinant KIT 20100310 BLA BLA103375 Baxter Healthcare Corporation 0944-2845_4914a5e8-6861-4af7-b26a-33977dd32004 0944-2845 PLASMA DERIVATIVE RECOMBINATE antihemophilic factor recombinant KIT 20100310 BLA BLA103375 Baxter Healthcare Corporation 0944-2884_2957e386-d11e-4af4-89c0-feca4925015e 0944-2884 PLASMA DERIVATIVE GLASSIA Alpha-1-Proteinase Inhibitor (Human) INJECTION, SOLUTION INTRAVENOUS 20110531 BLA BLA125325 Baxter Healthcare Corporation .ALPHA.1-PROTEINASE INHIBITOR HUMAN 1 g/50mL Human alpha-1 Proteinase Inhibitor [EPC],Trypsin Inhibitors [MoA] 0944-2921_8bce6662-bbf4-4eec-a477-dc53afa1eb80 0944-2921 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20110204 BLA BLA125063 Baxter Healthcare Corporation 0944-2922_8bce6662-bbf4-4eec-a477-dc53afa1eb80 0944-2922 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20110204 BLA BLA125063 Baxter Healthcare Corporation 0944-2923_8bce6662-bbf4-4eec-a477-dc53afa1eb80 0944-2923 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20110204 BLA BLA125063 Baxter Healthcare Corporation 0944-2924_8bce6662-bbf4-4eec-a477-dc53afa1eb80 0944-2924 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20110204 BLA BLA125063 Baxter Healthcare Corporation 0944-2948_8bce6662-bbf4-4eec-a477-dc53afa1eb80 0944-2948 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20030725 BLA BLA125063 Baxter Healthcare Corporation 0944-2960_8bce6662-bbf4-4eec-a477-dc53afa1eb80 0944-2960 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20030725 BLA BLA125063 Baxter Healthcare Corporation 0944-2961_8bce6662-bbf4-4eec-a477-dc53afa1eb80 0944-2961 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20030725 BLA BLA125063 Baxter Healthcare Corporation 0944-2962_8bce6662-bbf4-4eec-a477-dc53afa1eb80 0944-2962 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20030725 BLA BLA125063 Baxter Healthcare Corporation 0944-2963_8bce6662-bbf4-4eec-a477-dc53afa1eb80 0944-2963 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20030725 BLA BLA125063 Baxter Healthcare Corporation 0944-2964_8bce6662-bbf4-4eec-a477-dc53afa1eb80 0944-2964 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20030725 BLA BLA125063 Baxter Healthcare Corporation 0944-2965_8bce6662-bbf4-4eec-a477-dc53afa1eb80 0944-2965 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20030725 BLA BLA125063 Baxter Healthcare Corporation 0944-3026_8cc2cfc6-0750-4a9f-a46e-b1c1c36bf532 0944-3026 PLASMA DERIVATIVE RIXUBIS COAGULATION FACTOR IX RECOMBINANT HUMAN KIT 20130626 BLA BLA125446 Baxter Healthcare Corporation 0944-3028_8cc2cfc6-0750-4a9f-a46e-b1c1c36bf532 0944-3028 PLASMA DERIVATIVE RIXUBIS COAGULATION FACTOR IX RECOMBINANT HUMAN KIT 20130626 BLA BLA125446 Baxter Healthcare Corporation 0944-3030_8cc2cfc6-0750-4a9f-a46e-b1c1c36bf532 0944-3030 PLASMA DERIVATIVE RIXUBIS COAGULATION FACTOR IX RECOMBINANT HUMAN KIT 20130626 BLA BLA125446 Baxter Healthcare Corporation 0944-3032_8cc2cfc6-0750-4a9f-a46e-b1c1c36bf532 0944-3032 PLASMA DERIVATIVE RIXUBIS COAGULATION FACTOR IX RECOMBINANT HUMAN KIT 20130626 BLA BLA125446 Baxter Healthcare Corporation 0944-3034_8cc2cfc6-0750-4a9f-a46e-b1c1c36bf532 0944-3034 PLASMA DERIVATIVE RIXUBIS COAGULATION FACTOR IX RECOMBINANT HUMAN KIT 20130626 BLA BLA125446 Baxter Healthcare Corporation 0944-3045_80fa03d2-cd4c-4155-9b57-1396c4fa42da 0944-3045 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20140625 BLA BLA125063 Baxter Healthcare Corporation 0944-3046_80fa03d2-cd4c-4155-9b57-1396c4fa42da 0944-3046 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20140725 BLA BLA125063 Baxter Healthcare Corporation 0944-3047_80fa03d2-cd4c-4155-9b57-1396c4fa42da 0944-3047 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20140625 BLA BLA125063 Baxter Healthcare Corporation 0944-3051_80fa03d2-cd4c-4155-9b57-1396c4fa42da 0944-3051 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20140625 BLA BLA125063 Baxter Healthcare Corporation 0944-3052_80fa03d2-cd4c-4155-9b57-1396c4fa42da 0944-3052 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20140625 BLA BLA125063 Baxter Healthcare Corporation 0944-3053_80fa03d2-cd4c-4155-9b57-1396c4fa42da 0944-3053 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20140625 BLA BLA125063 Baxter Healthcare Corporation 0944-3054_80fa03d2-cd4c-4155-9b57-1396c4fa42da 0944-3054 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20140625 BLA BLA125063 Baxter Healthcare Corporation 0944-3940_1212b06c-0455-42ed-98fa-1ffaf9730b89 0944-3940 PLASMA DERIVATIVE Hemofil M Antihemophilic Factor Human KIT 19880223 BLA BLA101448 Baxter Healthcare Corporation 0944-3942_1212b06c-0455-42ed-98fa-1ffaf9730b89 0944-3942 PLASMA DERIVATIVE Hemofil M Antihemophilic Factor Human KIT 19880223 BLA BLA101448 Baxter Healthcare Corporation 0944-3944_1212b06c-0455-42ed-98fa-1ffaf9730b89 0944-3944 PLASMA DERIVATIVE Hemofil M Antihemophilic Factor Human KIT 19880223 BLA BLA101448 Baxter Healthcare Corporation 0944-3946_1212b06c-0455-42ed-98fa-1ffaf9730b89 0944-3946 PLASMA DERIVATIVE Hemofil M Antihemophilic Factor Human KIT 19880223 BLA BLA101448 Baxter Healthcare Corporation 0944-4175_8d79a18f-cca1-4a81-8564-b839a645063c 0944-4175 HUMAN PRESCRIPTION DRUG CEPROTIN Protein C Concentrate Human KIT 20100809 BLA BLA125234 Baxter Healthcare Corporation 0944-4175_926914a9-78b2-40ea-b37d-2a55c09bf275 0944-4175 HUMAN PRESCRIPTION DRUG CEPROTIN Protein C Concentrate Human KIT 20100809 BLA BLA125234 Baxter Healthcare Corporation 0944-4201_106365cb-71aa-4c20-af32-5bbfe8cbf191 0944-4201 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 20110218 BLA BLA103980 Baxter Healthcare Corporation 0944-4201_c21e996f-e555-4b27-9da7-cf0600953646 0944-4201 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 20110218 BLA BLA103980 Baxter Healthcare Corporation 0944-4201_dc1d15c7-757f-470f-83c2-14b3d6512483 0944-4201 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 20110218 BLA BLA103980 Baxter Healthcare Corporation 0944-4201_e1aca067-0c96-4025-88bc-bd2345a46a30 0944-4201 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 20110218 BLA BLA103980 Baxter Healthcare Corporation 0944-4210_60e8272e-2a7d-42a5-af4b-3dbf727dd68f 0944-4210 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation 0944-4210_7d7abda1-9b76-43b2-8f74-0e376d9fe264 0944-4210 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation 0944-4211_60e8272e-2a7d-42a5-af4b-3dbf727dd68f 0944-4211 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation 0944-4211_7d7abda1-9b76-43b2-8f74-0e376d9fe264 0944-4211 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation 0944-4212_60e8272e-2a7d-42a5-af4b-3dbf727dd68f 0944-4212 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation 0944-4212_7d7abda1-9b76-43b2-8f74-0e376d9fe264 0944-4212 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation 0944-4301_60e8272e-2a7d-42a5-af4b-3dbf727dd68f 0944-4301 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation 0944-4301_7d7abda1-9b76-43b2-8f74-0e376d9fe264 0944-4301 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation 0944-4302_60e8272e-2a7d-42a5-af4b-3dbf727dd68f 0944-4302 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation 0944-4302_7d7abda1-9b76-43b2-8f74-0e376d9fe264 0944-4302 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation 0944-4303_60e8272e-2a7d-42a5-af4b-3dbf727dd68f 0944-4303 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation 0944-4303_7d7abda1-9b76-43b2-8f74-0e376d9fe264 0944-4303 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation 0944-4351_77e8fcef-6033-431a-bccd-361bd193a379 0944-4351 PLASMA DERIVATIVE ARTISS Fibrinogen human Thrombin human KIT 20080319 BLA BLA125266 Baxter Healthcare Corporation 0944-4351_906c38fb-0400-4440-8cc8-de27b2836640 0944-4351 PLASMA DERIVATIVE ARTISS Fibrinogen Human Thrombin Human KIT 20080319 BLA BLA125266 Baxter Healthcare Corporation 0944-4351_91150c14-6245-43ba-9915-00e61b8fca97 0944-4351 PLASMA DERIVATIVE ARTISS Fibrinogen Human Thrombin Human KIT 20080319 BLA BLA125266 Baxter Healthcare Corporation 0944-4351_bc16500a-1363-4468-a475-79345e4ad77a 0944-4351 PLASMA DERIVATIVE ARTISS Fibrinogen Human Thrombin Human KIT 20080319 BLA BLA125266 Baxter Healthcare Corporation 0944-4351_f6a4c69f-24f1-4129-80f1-fd4aaa315302 0944-4351 HUMAN PRESCRIPTION DRUG ARTISS Fibrinogen human Thrombin human KIT 20110111 BLA BLA125266 Baxter Healthcare Corporation 0944-4351_ff8475ca-6031-4654-887e-c72831d84130 0944-4351 HUMAN PRESCRIPTION DRUG ARTISS Fibrinogen human Thrombin human KIT 20110111 BLA BLA125266 Baxter Healthcare Corporation 0944-5001_a69ccbb3-7648-4978-8c6d-7ca6b95a9b01 0944-5001 PLASMA DERIVATIVE OBIZUR ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT KIT 20141023 BLA BLA125512 Baxter Healthcare Corporation 0944-8402_60e8272e-2a7d-42a5-af4b-3dbf727dd68f 0944-8402 PLASMA DERIVATIVE TISSEEL Frozen fibrinogen human and thrombin human SOLUTION TOPICAL 19980501 BLA BLA103980 Baxter Healthcare Corporation FIBRINOGEN HUMAN; THROMBIN HUMAN 90; 500 [iU]/mL; [iU]/mL Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] 0944-8402_7d7abda1-9b76-43b2-8f74-0e376d9fe264 0944-8402 PLASMA DERIVATIVE TISSEEL Frozen fibrinogen human and thrombin human SOLUTION TOPICAL 19980501 BLA BLA103980 Baxter Healthcare Corporation FIBRINOGEN HUMAN; THROMBIN HUMAN 90; 500 [iU]/mL; [iU]/mL Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] 0944-8402_c21e996f-e555-4b27-9da7-cf0600953646 0944-8402 PLASMA DERIVATIVE TISSEEL Frozen fibrinogen human and thrombin human SOLUTION TOPICAL 20110218 BLA BLA103980 Baxter Healthcare Corporation FIBRINOGEN; THROMBIN HUMAN 90; 500 [iU]/mL; [iU]/mL Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] 0944-8503_77e8fcef-6033-431a-bccd-361bd193a379 0944-8503 PLASMA DERIVATIVE ARTISS Frozen Fibrinogen Human Thrombin Human SOLUTION TOPICAL 20090319 BLA BLA125266 Baxter Healthcare Corporation FIBRINOGEN HUMAN; THROMBIN HUMAN 90; 4 mg/mL; [iU]/mL Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] 0944-8503_f6a4c69f-24f1-4129-80f1-fd4aaa315302 0944-8503 HUMAN PRESCRIPTION DRUG ARTISS Frozen Fibrinogen Human Thrombin Human SOLUTION TOPICAL 20110111 BLA BLA125266 Baxter Healthcare Corporation FIBRINOGEN; THROMBIN HUMAN 90; 4 mg/mL; [iU]/mL Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] 0944-8503_ff8475ca-6031-4654-887e-c72831d84130 0944-8503 HUMAN PRESCRIPTION DRUG ARTISS Frozen Fibrinogen human Thrombin human SOLUTION TOPICAL 20110111 BLA BLA125266 Baxter Healthcare Corporation FIBRINOGEN; THROMBIN HUMAN 90; 4 mg/mL; [iU]/mL Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] 0944-8701_b71f83ec-28cc-4cf8-9bfd-70d5f1dd8162 0944-8701 HUMAN PRESCRIPTION DRUG TachoSil THROMBIN HUMAN and FIBRINOGEN PATCH TOPICAL 20100405 BLA BLA125351 Baxter Healthcare Corporation FIBRINOGEN HUMAN; THROMBIN HUMAN 2; 5.5 [USP'U]/1; mg/1 Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] 0944-8702_b71f83ec-28cc-4cf8-9bfd-70d5f1dd8162 0944-8702 HUMAN PRESCRIPTION DRUG TachoSil THROMBIN HUMAN and FIBRINOGEN PATCH TOPICAL 20100405 BLA BLA125351 Baxter Healthcare Corporation FIBRINOGEN HUMAN; THROMBIN HUMAN 2; 5.5 [USP'U]/1; mg/1 Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] 0944-8703_b71f83ec-28cc-4cf8-9bfd-70d5f1dd8162 0944-8703 HUMAN PRESCRIPTION DRUG TachoSil THROMBIN HUMAN and FIBRINOGEN PATCH TOPICAL 20100405 BLA BLA125351 Baxter Healthcare Corporation FIBRINOGEN HUMAN; THROMBIN HUMAN 2; 5.5 [USP'U]/1; mg/1 Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] 0955-0251_5da66115-88b5-43e0-8a3b-69b71c65b4dc 0955-0251 HUMAN PRESCRIPTION DRUG Ergocalciferol ergocalciferol CAPSULE, LIQUID FILLED ORAL 20091110 NDA AUTHORIZED GENERIC NDA003444 Winthrop U.S. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 0955-1003_8012fd96-8cbf-49d4-8e66-d4d1794ce080 0955-1003 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20111003 NDA AUTHORIZED GENERIC NDA020164 Winthrop U.S. ENOXAPARIN SODIUM 30 mg/.3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0955-1004_8012fd96-8cbf-49d4-8e66-d4d1794ce080 0955-1004 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20111003 NDA AUTHORIZED GENERIC NDA020164 Winthrop U.S. ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0955-1006_8012fd96-8cbf-49d4-8e66-d4d1794ce080 0955-1006 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20111003 NDA AUTHORIZED GENERIC NDA020164 Winthrop U.S. ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0955-1008_8012fd96-8cbf-49d4-8e66-d4d1794ce080 0955-1008 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20111003 NDA AUTHORIZED GENERIC NDA020164 Winthrop U.S. ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0955-1010_8012fd96-8cbf-49d4-8e66-d4d1794ce080 0955-1010 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20111003 NDA AUTHORIZED GENERIC NDA020164 Winthrop U.S. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0955-1012_8012fd96-8cbf-49d4-8e66-d4d1794ce080 0955-1012 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20111003 NDA AUTHORIZED GENERIC NDA020164 Winthrop U.S. ENOXAPARIN SODIUM 120 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0955-1015_8012fd96-8cbf-49d4-8e66-d4d1794ce080 0955-1015 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20111003 NDA AUTHORIZED GENERIC NDA020164 Winthrop U.S. ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0955-1016_8012fd96-8cbf-49d4-8e66-d4d1794ce080 0955-1016 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20111003 NDA AUTHORIZED GENERIC NDA020164 Winthrop U.S. ENOXAPARIN SODIUM 300 mg/3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 0955-1020_83b50e02-e72f-4cbd-a73e-7a28ec5a7aa5 0955-1020 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20101021 NDA NDA020449 Winthrop U.S. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 0955-1021_83b50e02-e72f-4cbd-a73e-7a28ec5a7aa5 0955-1021 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20101021 NDA NDA020449 Winthrop U.S. DOCETAXEL 80 mg/4mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 0955-1025_1be09629-8df0-4a8a-998b-fc6d651f5409 0955-1025 HUMAN PRESCRIPTION DRUG levocetirizine dihydrochloride levocetirizine dihydrochloride TABLET, FILM COATED ORAL 20070809 NDA NDA022064 Winthrop U.S. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0955-1026_1be09629-8df0-4a8a-998b-fc6d651f5409 0955-1026 HUMAN PRESCRIPTION DRUG levocetirizine dihydrochloride levocetirizine dihydrochloride SOLUTION ORAL 20080402 NDA NDA022157 Winthrop U.S. LEVOCETIRIZINE DIHYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 0955-1030_374a094f-5f1b-49a8-86a9-06780b524679 0955-1030 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride desipramine hydrochloride TABLET, SUGAR COATED ORAL 20140401 NDA AUTHORIZED GENERIC NDA014399 Winthrop U.S. DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 0955-1031_374a094f-5f1b-49a8-86a9-06780b524679 0955-1031 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride desipramine hydrochloride TABLET, SUGAR COATED ORAL 20140401 NDA AUTHORIZED GENERIC NDA014399 Winthrop U.S. DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 0955-1032_374a094f-5f1b-49a8-86a9-06780b524679 0955-1032 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride desipramine hydrochloride TABLET, SUGAR COATED ORAL 20140401 NDA AUTHORIZED GENERIC NDA014399 Winthrop U.S. DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 0955-1033_374a094f-5f1b-49a8-86a9-06780b524679 0955-1033 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride desipramine hydrochloride TABLET, SUGAR COATED ORAL 20140401 NDA AUTHORIZED GENERIC NDA014399 Winthrop U.S. DESIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 0955-1034_374a094f-5f1b-49a8-86a9-06780b524679 0955-1034 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride desipramine hydrochloride TABLET, SUGAR COATED ORAL 20140401 NDA AUTHORIZED GENERIC NDA014399 Winthrop U.S. DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 0955-1035_374a094f-5f1b-49a8-86a9-06780b524679 0955-1035 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride desipramine hydrochloride TABLET, SUGAR COATED ORAL 20140401 NDA AUTHORIZED GENERIC NDA014399 Winthrop U.S. DESIPRAMINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 0955-1037_9188940f-72bf-428e-8c6a-789e0fe24a78 0955-1037 HUMAN PRESCRIPTION DRUG Methenamine Hippurate Methenamine Hippurate TABLET ORAL 20120123 NDA NDA017681 Winthrop U.S. METHENAMINE HIPPURATE 1 g/1 0955-1040_d33801c1-90fd-40ad-905d-8dc71ec657ef 0955-1040 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET, FILM COATED ORAL 20120301 20621231 NDA NDA020757 Winthrop U.S. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0955-1041_d33801c1-90fd-40ad-905d-8dc71ec657ef 0955-1041 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET, FILM COATED ORAL 20120301 20621231 NDA NDA020757 Winthrop U.S. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0955-1042_d33801c1-90fd-40ad-905d-8dc71ec657ef 0955-1042 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET, FILM COATED ORAL 20120301 20621231 NDA NDA020757 Winthrop U.S. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 0955-1045_39b54275-057a-468b-b151-99fd23a5706a 0955-1045 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20120301 20621231 NDA NDA020758 Winthrop U.S. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0955-1046_39b54275-057a-468b-b151-99fd23a5706a 0955-1046 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20120301 20621231 NDA NDA020758 Winthrop U.S. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 0955-1702_e1bc1126-e62f-46d4-bed4-0a433de21658 0955-1702 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101014 NDA AUTHORIZED GENERIC NDA021774 Winthrop U.S, a business of sanofi-aventis U.S. LLC ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0955-1703_e1bc1126-e62f-46d4-bed4-0a433de21658 0955-1703 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101206 NDA AUTHORIZED GENERIC NDA021774 Winthrop U.S, a business of sanofi-aventis U.S. LLC ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 0955-1710_d163acd6-53cc-4c6c-b2bc-e11af28f7181 0955-1710 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE SPRAY, METERED NASAL 20110615 NDA AUTHORIZED GENERIC NDA020468 Winthrop U.S. TRIAMCINOLONE ACETONIDE 55 ug/1 0955-1725_8c7f1b58-b6e4-40a2-8121-947fb44636a8 0955-1725 HUMAN PRESCRIPTION DRUG OXALIPLATIN oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140707 NDA AUTHORIZED GENERIC NDA021759 Winthrop U.S. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0955-1727_8c7f1b58-b6e4-40a2-8121-947fb44636a8 0955-1727 HUMAN PRESCRIPTION DRUG OXALIPLATIN oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140707 NDA AUTHORIZED GENERIC NDA021759 Winthrop U.S. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 0998-0016_5655c4cf-de99-431a-96e1-30e8a1bd657e 0998-0016 HUMAN PRESCRIPTION DRUG Alcaine proparacaine hydrochloride SOLUTION OPHTHALMIC 19731019 ANDA ANDA080027 Alcon Laboratories, Inc. PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] 0998-0203_fb16671e-a0d5-88d6-dc8f-fd78e24be302 0998-0203 HUMAN PRESCRIPTION DRUG ISOPTO CARPINE pilocarpine hydrochloride SOLUTION OPHTHALMIC 19740101 NDA NDA200890 Alcon Laboratories, Inc. PILOCARPINE HYDROCHLORIDE 10 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 0998-0204_fb16671e-a0d5-88d6-dc8f-fd78e24be302 0998-0204 HUMAN PRESCRIPTION DRUG ISOPTO CARPINE pilocarpine hydrochloride SOLUTION OPHTHALMIC 19740101 NDA NDA200890 Alcon Laboratories, Inc. PILOCARPINE HYDROCHLORIDE 20 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 0998-0206_fb16671e-a0d5-88d6-dc8f-fd78e24be302 0998-0206 HUMAN PRESCRIPTION DRUG ISOPTO CARPINE pilocarpine hydrochloride SOLUTION OPHTHALMIC 19740101 NDA NDA200890 Alcon Laboratories, Inc. PILOCARPINE HYDROCHLORIDE 40 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 0998-0223_35e46b99-7858-7e94-9e55-abce25b57a28 0998-0223 HUMAN PRESCRIPTION DRUG Isopto Carbachol carbachol SOLUTION OPHTHALMIC 19810619 UNAPPROVED DRUG OTHER Alcon Laboratories, Inc. CARBACHOL 15 mg/mL Cholinergic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 0998-0225_35e46b99-7858-7e94-9e55-abce25b57a28 0998-0225 HUMAN PRESCRIPTION DRUG Isopto Carbachol carbachol SOLUTION OPHTHALMIC 19810619 UNAPPROVED DRUG OTHER Alcon Laboratories, Inc. CARBACHOL 30 mg/mL Cholinergic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 0998-0303_3870b0cd-09ce-c48b-eea1-4666b1cd7a12 0998-0303 HUMAN PRESCRIPTION DRUG Isopto Atropine atropine sulfate SOLUTION OPHTHALMIC 19810619 UNAPPROVED DRUG OTHER Alcon Laboratories, Inc. ATROPINE SULFATE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 0998-0311_ef0317d3-49c1-5afa-7edd-1aad10a20235 0998-0311 HUMAN PRESCRIPTION DRUG Isopto Homatropine homatropine hydrobromide SOLUTION OPHTHALMIC 19810619 UNAPPROVED DRUG OTHER Alcon Laboratories, Inc. HOMATROPINE HYDROBROMIDE 20 mg/mL Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0998-0315_ef0317d3-49c1-5afa-7edd-1aad10a20235 0998-0315 HUMAN PRESCRIPTION DRUG Isopto Homatropine homatropine hydrobromide SOLUTION OPHTHALMIC 19810619 UNAPPROVED DRUG OTHER Alcon Laboratories, Inc. HOMATROPINE HYDROBROMIDE 50 mg/mL Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 0998-0331_04b3b2ab-e575-0b38-e2dd-8e7627f58894 0998-0331 HUMAN PRESCRIPTION DRUG Isopto Hyoscine scopolamine hydrobromide SOLUTION OPHTHALMIC 19810619 UNAPPROVED DRUG OTHER Alcon Laboratories, Inc. SCOPOLAMINE HYDROBROMIDE 2.5 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0998-0342_815a92c2-db1c-f1fe-d065-f2a6bb621ad9 0998-0342 HUMAN PRESCRIPTION DRUG Mydfrin phenylephrine hydrochloride SOLUTION OPHTHALMIC 19900930 UNAPPROVED DRUG OTHER Alcon Laboratories, Inc. PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 0998-0355_0d4f4a2e-eb00-4c65-b3fa-baf5738d468d 0998-0355 HUMAN PRESCRIPTION DRUG Mydriacyl tropicamide SOLUTION OPHTHALMIC 19590401 ANDA ANDA084306 Alcon Laboratories, Inc. TROPICAMIDE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 0998-0408_c4e042cf-687f-93b6-7840-7b0385ce2f80 0998-0408 HUMAN OTC DRUG Isopto Tears Hypromellose 2910 SOLUTION OPHTHALMIC 19900930 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. HYPROMELLOSE 2910 (4000 MPA.S) 5 mg/mL 0998-0615_0e2252b9-6aa1-42ff-b0b0-bac1088feb03 0998-0615 HUMAN PRESCRIPTION DRUG Maxidex dexamethasone SUSPENSION OPHTHALMIC 19660515 NDA NDA013422 Alcon Laboratories, Inc. DEXAMETHASONE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 0998-0630_d114106c-3e46-4870-9d7b-2260ca28229f 0998-0630 HUMAN PRESCRIPTION DRUG Maxitrol neomycin sulfate, polymyxin b sulfate and dexamethasone SUSPENSION OPHTHALMIC 19641115 NDA NDA050023 Alcon Laboratories, Inc. DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10006-001_b8f5cc28-1546-47a9-9bc0-d60fa9745df9 10006-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company OXYGEN 99 L/100L 10006-002_c4065ed6-237f-4545-bad2-a51e95a70949 10006-002 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company NITROUS OXIDE 99 L/100L 10006-003_90f9a709-879d-4308-9287-862c93c0f12b 10006-003 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company CARBON DIOXIDE 99 kg/100kg Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 10006-004_a8b5c8ac-a3f7-4184-8ccf-020926d48fe0 10006-004 HUMAN PRESCRIPTION DRUG MEDICAL AIR AIR GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company OXYGEN 21 L/100L 10006-005_8bed956b-282d-414d-95fb-d33d0693800a 10006-005 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company NITROGEN 99 L/100L 10006-008_73d34d59-69b0-4bc0-b31d-617aa0d5b3fc 10006-008 HUMAN PRESCRIPTION DRUG HELIUM HELIUM GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company HELIUM 99 L/100L 10006-009_1366bd51-4f64-48d6-baa1-1fb402553331 10006-009 HUMAN PRESCRIPTION DRUG HELIOX HELIOX GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company OXYGEN 20 L/100L 10006-010_1366bd51-4f64-48d6-baa1-1fb402553331 10006-010 HUMAN PRESCRIPTION DRUG HELIOX HELIOX GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company OXYGEN 25 L/100L 10006-011_1366bd51-4f64-48d6-baa1-1fb402553331 10006-011 HUMAN PRESCRIPTION DRUG HELIOX HELIOX GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company OXYGEN 30 L/100L 10014-001_d8d2063c-e912-4b94-96b3-56d4d0c3b7e2 10014-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19721006 UNAPPROVED MEDICAL GAS Aero All Gas Company OXYGEN 990 mL/L 10014-002_932de9d0-8d69-4644-86fb-17ef377732e7 10014-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19721006 UNAPPROVED MEDICAL GAS Aero All Gas Company NITROGEN 990 mL/L 10014-003_a1bd5a47-42d2-4975-aab9-694b5103c1f0 10014-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19721006 UNAPPROVED MEDICAL GAS Aero All Gas Company NITROUS OXIDE 990 mL/L 10014-004_66601a69-05b5-4f56-90ce-619bb1db507e 10014-004 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19721006 UNAPPROVED MEDICAL GAS Aero All Gas Company HELIUM 990 mL/L 10014-005_6fac5c5c-93dc-49cf-80a8-fb06cb4bed13 10014-005 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19721006 UNAPPROVED MEDICAL GAS Aero All Gas Company CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 10014-006_94c04484-ab76-4efe-a49b-7477cb935446 10014-006 HUMAN PRESCRIPTION DRUG Oxygen Helium Mixture Oxygen Helium Mixture GAS RESPIRATORY (INHALATION) 19721006 UNAPPROVED MEDICAL GAS Aero All Gas Company HELIUM; OXYGEN 800; 200 mL/L; mL/L 10014-007_0b1b75b5-757c-4382-8811-01a71f648641 10014-007 HUMAN PRESCRIPTION DRUG Oxygen Helium Mixture 40/60 Oxygen Helium Mixture 40/60 GAS RESPIRATORY (INHALATION) 19721006 UNAPPROVED MEDICAL GAS Aero All Gas Company HELIUM; OXYGEN 600; 400 mL/L; mL/L 10018-8999_7eeeb31e-890b-4b18-a36a-51f11fdcf88c 10018-8999 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20050101 NDA NDA205865 Air Products and Chemicals, Inc. OXYGEN 990 mL/L 10018-9502_c12d5de2-dd87-4db2-bcf8-48c7239ed8ed 10018-9502 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20050101 NDA NDA205866 Air Products and Chemicals, Inc. NITROGEN 990 mL/L 10018-9505_6bbe6aca-7f15-4823-9440-abba441bcbe0 10018-9505 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 20050101 NDA NDA205864 Air Products and Chemicals, Inc. HELIUM 990 mL/L 10019-016_3aec6f31-a792-4ce1-b603-7179f7f5d29b 10019-016 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101217 NDA NDA017558 Baxter Healthcare Corporation GLYCOPYRROLATE .2 mg/mL 10019-027_78f5eaeb-6fcb-4a7f-91ce-871d2d5378f3 10019-027 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20100304 ANDA ANDA075243 Baxter Healthcare Corporation MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 10019-028_78f5eaeb-6fcb-4a7f-91ce-871d2d5378f3 10019-028 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20100304 ANDA ANDA075243 Baxter Healthcare Corporation MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 10019-029_4be70158-f47e-4381-9491-6dd556abb982 10019-029 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100629 ANDA ANDA075772 Baxter Healthcare Corporation KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10019-030_4be70158-f47e-4381-9491-6dd556abb982 10019-030 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100629 ANDA ANDA075772 Baxter Healthcare Corporation KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10019-033_550d42a8-7410-4e89-85f8-30dd1bf26149 10019-033 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100625 ANDA ANDA019101 Baxter Healthcare Corporation FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10019-035_550d42a8-7410-4e89-85f8-30dd1bf26149 10019-035 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100625 ANDA ANDA019101 Baxter Healthcare Corporation FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10019-037_550d42a8-7410-4e89-85f8-30dd1bf26149 10019-037 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100625 ANDA ANDA019101 Baxter Healthcare Corporation FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10019-038_550d42a8-7410-4e89-85f8-30dd1bf26149 10019-038 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100625 ANDA ANDA019101 Baxter Healthcare Corporation FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10019-055_97473766-f1d0-4ac6-a788-4604cf852db8 10019-055 HUMAN PRESCRIPTION DRUG Brevibloc Esmolol Hydrochloride INJECTION INTRAVENOUS 19861231 NDA NDA019386 Baxter Healthcare Corporation ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 10019-063_5bca8860-de02-4c7f-bb43-01dfe4aea139 10019-063 HUMAN PRESCRIPTION DRUG Adenosine ADENOSINE INJECTION, SOLUTION INTRAVENOUS 20100420 ANDA ANDA076501 Baxter Healthcare Corporation ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 10019-063_b4a82bd5-74d9-427f-a6b5-95d02c660447 10019-063 HUMAN PRESCRIPTION DRUG Adenosine ADENOSINE INJECTION, SOLUTION INTRAVENOUS 20100420 ANDA ANDA076500 Baxter Healthcare Corporation ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 10019-075_97473766-f1d0-4ac6-a788-4604cf852db8 10019-075 HUMAN PRESCRIPTION DRUG Brevibloc Esmolol Hydrochloride INJECTION INTRAVENOUS 19861231 NDA NDA019386 Baxter Healthcare Corporation ESMOLOL HYDROCHLORIDE 20 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 10019-097_add1d778-f9f7-4844-b39b-524824cb446d 10019-097 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091210 ANDA ANDA083312 BAXTER HEALTHCARE CORPORATION PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 10019-098_b53894b3-fbe7-4acd-bf50-9d14c47ee3c8 10019-098 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20030930 ANDA ANDA065125 BAXTER HEALTHCARE CORPORATION CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 10019-105_095ab8ff-83c5-4906-ae67-b04f4a58b58d 10019-105 HUMAN PRESCRIPTION DRUG Lorazepam LORAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050923 NDA NDA018140 BAXTER HEALTHCARE CORPORATION LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 10019-106_095ab8ff-83c5-4906-ae67-b04f4a58b58d 10019-106 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050923 NDA NDA018140 BAXTER HEALTHCARE CORPORATION LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 10019-115_97473766-f1d0-4ac6-a788-4604cf852db8 10019-115 HUMAN PRESCRIPTION DRUG Brevibloc Esmolol Hydrochloride INJECTION INTRAVENOUS 19861231 NDA NDA019386 Baxter Healthcare Corporation ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 10019-120_55688c8d-46e2-4e5f-ace5-2a12b878c719 10019-120 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride Esmolol Hydrochloride INJECTION INTRAVENOUS 19861231 NDA NDA019386 Baxter Healthcare Corporation ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 10019-163_72348406-e74f-46c5-b93d-34d07cffe1fd 10019-163 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride PHENYLEPHRINE HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100409 UNAPPROVED DRUG OTHER Baxter Healthcare Corporation PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 10019-176_22055b20-bc20-4e45-8574-4b218e0901e4 10019-176 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100526 UNAPPROVED DRUG OTHER Baxter Healthcare Corporation MORPHINE SULFATE 5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10019-177_22055b20-bc20-4e45-8574-4b218e0901e4 10019-177 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100526 UNAPPROVED DRUG OTHER Baxter Healthcare Corporation MORPHINE SULFATE 8 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10019-178_22055b20-bc20-4e45-8574-4b218e0901e4 10019-178 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100526 UNAPPROVED DRUG OTHER Baxter Healthcare Corporation MORPHINE SULFATE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10019-179_22055b20-bc20-4e45-8574-4b218e0901e4 10019-179 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100526 UNAPPROVED DRUG OTHER Baxter Healthcare Corporation MORPHINE SULFATE 15 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10019-291_69766b0a-85af-4a11-94dd-ed8e31a6967d 10019-291 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION INTRAMUSCULAR; INTRAVENOUS 20090626 NDA NDA018243 Baxter Healthcare Corporation OXYTOCIN 10 [USP'U]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 10019-321_557764fc-8493-44f8-b47b-c6dba6e97558 10019-321 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION, SOLUTION INTRAVENOUS 20100526 ANDA ANDA076787 Baxter Healthcare Corporation FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 10019-360_0d0a8447-4e52-4a1c-87c9-2e89e5cad924 10019-360 HUMAN PRESCRIPTION DRUG FORANE isoflurane INHALANT RESPIRATORY (INHALATION) 20110808 NDA NDA017624 Baxter Healthcare Corporation ISOFLURANE 1 mL/mL General Anesthesia [PE],General Anesthetic [EPC] 10019-450_e3ccfb03-86cc-46f0-b206-4806ab33b5d6 10019-450 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101209 NDA NDA017862 Baxter Healthcare Corporation METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 10019-506_5977d260-0e7f-4143-bfc4-a20a65a3c2ac 10019-506 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide INJECTION INTRAMUSCULAR; INTRAVENOUS 20090127 ANDA ANDA079196 Baxter Healthcare Corporation BUMETANIDE .25 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 10019-510_7d521e5d-b39d-4ebe-b1a6-0f12654c6b8c 10019-510 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20100713 ANDA ANDA078538 Baxter Healthcare Corporation DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 10019-553_9caea3f4-e7e2-4d24-b3b6-5e62f37b3ec8 10019-553 HUMAN PRESCRIPTION DRUG Transderm Scop Scopalamine PATCH, EXTENDED RELEASE TRANSDERMAL 20030101 NDA NDA017874 Baxter Healthcare Corporation SCOPOLAMINE 1 mg/3d Anticholinergic [EPC],Cholinergic Antagonists [MoA] 10019-630_80c510fb-099a-4a49-8382-47daa64a07b3 10019-630 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and Sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100224 ANDA ANDA065406 Baxter Healthcare Corporation AMPICILLIN SODIUM; SULBACTAM SODIUM 250; 125 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 10019-631_80c510fb-099a-4a49-8382-47daa64a07b3 10019-631 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and Sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100224 ANDA ANDA065406 Baxter Healthcare Corporation AMPICILLIN SODIUM; SULBACTAM SODIUM 250; 125 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 10019-632_50af5370-9d98-4519-beed-8dbb36203a24 10019-632 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100415 ANDA ANDA065403 Baxter Healthcare Corporation AMPICILLIN SODIUM; SULBACTAM SODIUM 100; 50 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 10019-633_80934a65-b355-45a3-bdba-d91c33b3c119 10019-633 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam AMPICILLIN, SULBACTAM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100224 ANDA ANDA065406 Baxter Healthcare Corporation AMPICILLIN SODIUM; SULBACTAM SODIUM 250; 125 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 10019-634_80934a65-b355-45a3-bdba-d91c33b3c119 10019-634 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam AMPICILLIN, SULBACTAM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100224 ANDA ANDA065406 Baxter Healthcare Corporation AMPICILLIN SODIUM; SULBACTAM SODIUM 250; 125 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 10019-635_0c075300-1573-44a6-a38d-0c19debc2aae 10019-635 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100415 ANDA ANDA065403 Baxter Healthcare Corporation AMPICILLIN SODIUM; SULBACTAM SODIUM 100; 50 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 10019-636_0d71adad-7c35-4078-9611-cd4817478f28 10019-636 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam AMPICILLIN, SULBACTAM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100224 ANDA ANDA065406 Baxter Healthcare Corporation AMPICILLIN SODIUM; SULBACTAM SODIUM 250; 125 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 10019-637_0d71adad-7c35-4078-9611-cd4817478f28 10019-637 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam AMPICILLIN, SULBACTAM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100224 ANDA ANDA065406 Baxter Healthcare Corporation AMPICILLIN SODIUM; SULBACTAM SODIUM 250; 125 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 10019-638_4ef7df2b-09f4-415d-9c58-20e2e861a1e7 10019-638 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100415 ANDA ANDA065403 Baxter Healthcare Corporation AMPICILLIN SODIUM; SULBACTAM SODIUM 100; 50 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 10019-641_4d3ead80-6c74-4a79-96f9-49471d993b91 10019-641 HUMAN PRESCRIPTION DRUG SUPRANE desflurane LIQUID RESPIRATORY (INHALATION) 19920918 NDA NDA020118 Baxter Healthcare Corporation DESFLURANE 240 mL/240mL General Anesthesia [PE],General Anesthetic [EPC] 10019-644_aad244dc-bdf3-4eb8-8f75-59e286606016 10019-644 HUMAN PRESCRIPTION DRUG Suprane DESFLURANE LIQUID RESPIRATORY (INHALATION) 19920918 NDA NDA020118 Baxter Healthcare Corporation DESFLURANE 240 mL/240mL General Anesthesia [PE],General Anesthetic [EPC] 10019-646_07cf78b6-d08e-4174-98bd-0e8725eeb92e 10019-646 HUMAN PRESCRIPTION DRUG SUPRANE DESFLURANE LIQUID RESPIRATORY (INHALATION) 19920918 NDA NDA020118 Baxter Healthcare Corporation DESFLURANE 240 mL/240mL General Anesthesia [PE],General Anesthetic [EPC] 10019-648_78a2b99d-5a13-4a71-ae4e-0596581f4dc5 10019-648 HUMAN PRESCRIPTION DRUG azithromycin azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19970101 NDA AUTHORIZED GENERIC NDA050733 Baxter Healthcare Corporation AZITHROMYCIN DIHYDRATE 100 mg/mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 10019-651_2c78ee69-3ebb-4b17-abe4-de5a565f270b 10019-651 HUMAN PRESCRIPTION DRUG Sevoflurane Sevoflurane LIQUID RESPIRATORY (INHALATION) 20111018 ANDA ANDA075895 Baxter Healthcare Corporation SEVOFLURANE 250 mL/250mL General Anesthesia [PE],General Anesthetic [EPC] 10019-653_4eacde49-8d1e-409c-a8a5-1a8a766788fa 10019-653 HUMAN PRESCRIPTION DRUG SEVOFLURANE Sevoflurane LIQUID RESPIRATORY (INHALATION) 20020707 ANDA ANDA075895 Baxter Healthcare Corporation SEVOFLURANE 250 mL/250mL General Anesthesia [PE],General Anesthetic [EPC] 10019-905_8fbb0587-055a-40f2-9433-8705d1647fd1 10019-905 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101119 ANDA ANDA077541 Baxter Healthcare Corporation ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 10019-905_a6063c54-a952-4459-9f03-0b9499c22820 10019-905 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101119 ANDA ANDA077541 Baxter Healthcare Corporation ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 10019-906_8fbb0587-055a-40f2-9433-8705d1647fd1 10019-906 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101119 ANDA ANDA077365 Baxter Healthcare Corporation ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 10019-906_a6063c54-a952-4459-9f03-0b9499c22820 10019-906 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101119 ANDA ANDA077365 Baxter Healthcare Corporation ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 10019-925_7d429e83-9514-41aa-8c43-ec015110da15 10019-925 HUMAN PRESCRIPTION DRUG IFOSFAMIDE IFOSFAMIDE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19881230 NDA NDA019763 Baxter Healthcare Corporation IFOSFAMIDE 1 g/20mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10019-926_7d429e83-9514-41aa-8c43-ec015110da15 10019-926 HUMAN PRESCRIPTION DRUG IFOSFAMIDE IFOSFAMIDE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19881230 NDA NDA019763 Baxter Healthcare Corporation IFOSFAMIDE 3 g/60mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10019-935_6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe 10019-935 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 500 mg/25mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10019-936_6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe 10019-936 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 1 g/50mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10019-937_6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe 10019-937 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 2 g/100mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10019-938_97ab446f-5017-4180-ae65-0a355289b0ed 10019-938 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 500 mg/25mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10019-939_97ab446f-5017-4180-ae65-0a355289b0ed 10019-939 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 1 g/50mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10019-942_97ab446f-5017-4180-ae65-0a355289b0ed 10019-942 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 2 g/100mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10019-943_cef038cc-efab-46d9-99c2-95bb11d6c9bc 10019-943 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 500 mg/25mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10019-944_cef038cc-efab-46d9-99c2-95bb11d6c9bc 10019-944 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 1 g/50mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10019-945_cef038cc-efab-46d9-99c2-95bb11d6c9bc 10019-945 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 2 g/100mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10019-953_6e432b9f-6217-406f-a73d-c2f649b1e490 10019-953 HUMAN PRESCRIPTION DRUG MESNA MESNA INJECTION, SOLUTION INTRAVENOUS 19881230 NDA NDA019884 Baxter Healthcare Corporation MESNA 100 mg/mL Cytoprotective Agent [EPC] 10019-955_76533b44-b0a8-44ae-80c0-ec15e4f9cc9a 10019-955 HUMAN PRESCRIPTION DRUG Cyclophosphamide cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 500 mg/25mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10019-956_76533b44-b0a8-44ae-80c0-ec15e4f9cc9a 10019-956 HUMAN PRESCRIPTION DRUG Cyclophosphamide cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 1 g/50mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10019-957_76533b44-b0a8-44ae-80c0-ec15e4f9cc9a 10019-957 HUMAN PRESCRIPTION DRUG Cyclophosphamide cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 2 g/100mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10019-988_38c490bd-6282-44a1-a6fa-b040b6b113a7 10019-988 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE Cyclophosphamide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; ORAL 19591116 NDA NDA012142 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 500 mg/25mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10019-989_38c490bd-6282-44a1-a6fa-b040b6b113a7 10019-989 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE Cyclophosphamide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; ORAL 19591116 NDA NDA012142 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 1 g/50mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10019-990_38c490bd-6282-44a1-a6fa-b040b6b113a7 10019-990 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE Cyclophosphamide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; ORAL 19591116 NDA NDA012142 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 2 g/100mL Alkylating Activity [MoA],Alkylating Drug [EPC] 10038-250_b009a672-63ac-45f5-93ea-1a251e03dcde 10038-250 HUMAN OTC DRUG Ambix First Aid DYCLONINE HYDROCHLORIDE and Phenol CREAM TOPICAL 20130822 OTC MONOGRAPH NOT FINAL part333A Organics Corporation of America dba Ambix Laboratories DYCLONINE HYDROCHLORIDE; PHENOL .005; .005 g/g; g/g 10056-047_bd7e8ce0-ae3f-4e2d-82fb-340531eb0eb7 10056-047 HUMAN OTC DRUG formu care ranitidine Ranitidine TABLET ORAL 20100924 ANDA ANDA078653 Access Business Group LLC RANITIDINE HYDROCHLORIDE 150 mg/1 10056-060_07231126-be11-4718-bfe2-61e029737a7b 10056-060 HUMAN OTC DRUG Satinique Dandruff Control Hair Cleanser PYRITHIONE ZINC SHAMPOO TOPICAL 20110411 OTC MONOGRAPH FINAL part358H Access Business Group, LLC PYRITHIONE ZINC .95 mL/100mL 10056-061_47f5310d-eb6c-4d3d-818e-25fdff841947 10056-061 HUMAN OTC DRUG fulton street market nighttime flu and severe cold and cough Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20100914 OTC MONOGRAPH FINAL part341 Access Business Group LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 10056-067_48ebece9-5deb-44c5-941f-3b7616cce8b7 10056-067 HUMAN OTC DRUG Formucare Triple Antibiotic Original Strength bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20090821 OTC MONOGRAPH FINAL part333B Access Business Group LLC BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 10056-100_c22540e7-27f1-466b-b81a-02fc75f49f98 10056-100 HUMAN OTC DRUG Artistry Hydrating Foundation SPF 20 UBV/UVA ZINC OXIDE, OCTINOXATE CREAM TOPICAL 20110308 OTC MONOGRAPH NOT FINAL part352 Access Busines Group LLC OCTINOXATE; ZINC OXIDE 7.5; 2 mL/100mL; mL/100mL 10056-105_fcf45ba9-2848-4925-ab03-8a262863763c 10056-105 HUMAN OTC DRUG fulton street market triple antibiotic original strength bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20090821 OTC MONOGRAPH FINAL part333B Access Business Group LLC BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 10056-128_ed1c6b88-ebb6-4cb9-9469-33601a0c0649 10056-128 HUMAN OTC DRUG Artistry Essentials Hydrating SPF 15 OXYBENZONE, OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC OCTINOXATE; OXYBENZONE; ZINC OXIDE 6.5; 2; 3.43 mL/100mL; mL/100mL; mL/100mL 10056-131_74a9ac39-653a-44c6-abb4-37198a6644a2 10056-131 HUMAN OTC DRUG Artistry Essentials Balancing OXYBENZONE, OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC OCTINOXATE; OXYBENZONE; ZINC OXIDE 6.5; 2; 3.92 mL/100mL; mL/100mL; mL/100mL 10056-134_4215a09f-f8ad-409d-b7be-914f08368863 10056-134 HUMAN OTC DRUG Artistry Essentials Anti-Blemish Acne Treatment SALICYLIC ACID LOTION TOPICAL 20110727 OTC MONOGRAPH NOT FINAL part333D Access Business Group SALICYLIC ACID 1.1 mL/100mL 10056-135_6a7a09bb-45bb-4b8b-8a73-7279b6756271 10056-135 HUMAN OTC DRUG QuickFlex Menthol CREAM TOPICAL 20100530 OTC MONOGRAPH NOT FINAL part348 Access Business Group International LLC MENTHOL 1.25 g/100g 10056-161_0142f0f1-5e92-4eec-a53d-482b975c012e 10056-161 HUMAN OTC DRUG Artistry Balancing Foundation ZINC OXIDE, OCTINOXATE LOTION TOPICAL 20110727 OTC MONOGRAPH NOT FINAL part352 Access Business Group OCTINOXATE; ZINC OXIDE 7.5; 2 mL/100mL; mL/100mL 10056-175_a22594a2-1dbb-43cf-833e-5c371a091e30 10056-175 HUMAN OTC DRUG Body Essentials Hand and Body Moisturizing Formula SPF 8 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC OCTINOXATE; OXYBENZONE 7; 3 mL/100mL; mL/100mL 10056-178_eae04a2e-02b2-4fe2-bbf7-8b73f3b0d09f 10056-178 HUMAN OTC DRUG Body Series Deodorant and Antiperspirant Roll-On Regular Scent ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20110411 OTC MONOGRAPH FINAL part350 Access Business Group, Inc. ALUMINUM CHLOROHYDRATE 25 mL/100mL 10056-179_69d7101b-3e96-4dba-9cf8-9c79dbd2691a 10056-179 HUMAN OTC DRUG formu care calcium antacid Calcium carbonate TABLET, CHEWABLE ORAL 20000611 OTC MONOGRAPH FINAL part331 Access Business Group LLC CALCIUM CARBONATE 750 mg/1 10056-205_4266bb07-bd58-4d28-9d0f-591d0ad3e1ab 10056-205 HUMAN OTC DRUG Formucare Athletes Foot Maximum Strength Tolnaftate SPRAY TOPICAL 20041111 OTC MONOGRAPH FINAL part333C Access Business Group LLC TOLNAFTATE 1 g/100g 10056-271_8c6abcf3-0979-49bf-82a8-3a3a367bdfcc 10056-271 HUMAN OTC DRUG FormuCare Ranitidine Ranitidine TABLET ORAL 20090909 ANDA ANDA076760 Access Business Group International LLC RANITIDINE HYDROCHLORIDE 75 mg/1 10056-276_996fdb69-57e0-4b39-8d0c-1a65fbae0f10 10056-276 HUMAN OTC DRUG Body Series Invisible Solid Deodorant and Antiperspirant Clean Scent ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY CREAM TOPICAL 20110405 OTC MONOGRAPH FINAL part350 Access Business Group ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g 10056-300_7ac9457b-582e-4d92-a75e-8f3d387cc55f 10056-300 HUMAN OTC DRUG Fulton Street Market pain relief extra strength Acetaminophen TABLET ORAL 20050721 OTC MONOGRAPH NOT FINAL part343 Access Business Group LLC ACETAMINOPHEN 500 mg/1 10056-306_2f689589-2a03-4907-ad26-6d5ea7b46caf 10056-306 HUMAN OTC DRUG Fulton Street Market Clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20110811 ANDA ANDA090685 Access Business Group LLC POLYETHYLENE GLYCOL 3350 17 g/17g 10056-329_c4c0b46b-d291-4f1c-9530-dcf748ac04d4 10056-329 HUMAN OTC DRUG FormuCare Nasal Spray Original Oxymetazoline HCl SPRAY NASAL 20070710 OTC MONOGRAPH FINAL part341 Access Business Group International LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 10056-359_f5bb290f-8319-47a4-9763-8c32e8d8b8d7 10056-359 HUMAN OTC DRUG FormuCare Cough Syrup DM Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 19980720 OTC MONOGRAPH FINAL part341 Access Business Group LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 10056-368_07ce84c8-324c-4fc9-a8cc-14259d9a42a8 10056-368 HUMAN OTC DRUG formucare naproxen sodium pain reliever fever reducer Naproxen Sodium TABLET, FILM COATED ORAL 20090929 ANDA ANDA074661 Access Business Group International LLC NAPROXEN SODIUM 220 mg/1 10056-400_54af4cbc-e49f-4c73-852e-d406ff2cb602 10056-400 HUMAN OTC DRUG Fulton Street Market Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20000706 ANDA ANDA074661 Access Business Group LLC NAPROXEN SODIUM 220 mg/1 10056-430_cbff09ff-51ba-48bf-82d8-2d8e2515ae39 10056-430 HUMAN OTC DRUG Formu Care pain reliever added strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19980720 OTC MONOGRAPH NOT FINAL part343 Access Business Group LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 10056-458_81a95e1b-e6e9-4e2c-92a1-ada14ba74975 10056-458 HUMAN OTC DRUG Fulton Street Market Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20090701 ANDA ANDA078336 Access Business Group LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 10056-477_56356cd0-54dc-4010-a5c8-c3b8d92688c4 10056-477 HUMAN OTC DRUG FORMUCARE FIBER LAXATIVE Calcium polycarbophil TABLET, FILM COATED ORAL 20000727 OTC MONOGRAPH NOT FINAL part334 Access Business Group LLC CALCIUM POLYCARBOPHIL 625 mg/1 10056-484_8968369b-e295-4cdb-9eac-2556e27d1cfe 10056-484 HUMAN OTC DRUG Formu Care pain relief Acetaminophen TABLET ORAL 20050721 OTC MONOGRAPH NOT FINAL part343 Access Business Group LLC ACETAMINOPHEN 500 mg/1 10056-503_ae86efb2-1101-4873-9fab-09476beade30 10056-503 HUMAN OTC DRUG laxative fiber Calcium polycarbophil TABLET, FILM COATED ORAL 20000727 OTC MONOGRAPH NOT FINAL part334 Access Business Group LLC CALCIUM POLYCARBOPHIL 625 mg/1 10056-530_7be2b3d8-c34a-4750-8e04-d19b2f43e60f 10056-530 HUMAN OTC DRUG Glister Multi-Action Fluoride Toothpaste SODIUM FLUORIDE PASTE, DENTIFRICE TOPICAL 20110411 OTC MONOGRAPH FINAL part355 Access Business Group, LLC SODIUM FLUORIDE .21 g/100g 10056-533_6cc9a7ba-855a-4b79-b4a4-ef27b7489488 10056-533 HUMAN OTC DRUG fulton street market Athletes Foot Tolnaftate CREAM TOPICAL 20090814 OTC MONOGRAPH NOT FINAL part333C Access Business Group LLC TOLNAFTATE 1 g/100g 10056-535_453470ad-6629-493e-8ea8-713cc67ce989 10056-535 HUMAN OTC DRUG FormuCare Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20060227 OTC MONOGRAPH NOT FINAL part343 Access Business Group International LLC ASPIRIN 81 mg/1 10056-541_83a89dae-80d8-48e8-8724-ef338c0d919b 10056-541 HUMAN OTC DRUG Formu Care Anti Itch maximum strength Hydrocortisone CREAM TOPICAL 20090812 OTC MONOGRAPH NOT FINAL part348 Access Business Group LLC HYDROCORTISONE 1 g/100g 10056-557_8a7fc5f5-4840-4d45-9caf-5fb82348c31a 10056-557 HUMAN OTC DRUG Fulton Street Market Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19910115 ANDA ANDA072096 Access Business Group LLC IBUPROFEN 200 mg/1 10056-604_d21649c7-dc1e-47aa-8ffa-565b8324d105 10056-604 HUMAN OTC DRUG formu care ibuprofen Ibuprofen TABLET ORAL 19910115 ANDA ANDA072096 Access Business Group LLC IBUPROFEN 200 mg/1 10056-612_22f0346f-dc4b-430d-97c1-4ac3b4ef5618 10056-612 HUMAN OTC DRUG FormuCare Allergy Relief Loratadine TABLET ORAL 20050127 ANDA ANDA076301 Access Business Group LLC LORATADINE 10 mg/1 10056-666_147d5f72-1e78-406f-b4aa-35ef6ed1e3ae 10056-666 HUMAN OTC DRUG Fulton Street Market Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20090708 NDA NDA022032 Access Business Group LLC OMEPRAZOLE 20 mg/1 10056-699_2eeeb1c5-b277-42da-8fc4-d0feb401b273 10056-699 HUMAN OTC DRUG Fulton Street Market Anti itch Hydrocortisone CREAM TOPICAL 20090812 OTC MONOGRAPH NOT FINAL part348 Access Business Group LLC HYDROCORTISONE 1 g/100g 10056-700_d05f1836-0df0-41e5-b505-9e928741f012 10056-700 HUMAN OTC DRUG Peter Island Sunscreen SPF 50 OCTOCRYLENE OXYBENZONE ZINC OXIDE LOTION TOPICAL 20121120 OTC MONOGRAPH NOT FINAL part352 ACCESS BUSINESS GROUP INTERNATIONAL LLC OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 2; 3.9 g/100g; g/100g; g/100g 10056-701_17e0c695-9b3b-4059-b74b-699f976ebc85 10056-701 HUMAN OTC DRUG Peter Island Continuous Sport Sunscreen SPF 50 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE SPRAY TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2; 6 g/100g; g/100g; g/100g; g/100g; g/100g 10056-702_7538b626-5241-431d-87a9-ee3b90de32d6 10056-702 HUMAN OTC DRUG Peter Island SunscreenSPF 50 SPF 50 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 10056-704_e21eeba7-b3f9-44da-90da-9b86ed1e87a3 10056-704 HUMAN OTC DRUG Peter Island Sunscreen SPF 70 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20130628 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g 10056-705_295f3a7c-6aaa-4590-beb9-2aa29f2149cf 10056-705 HUMAN OTC DRUG Peter Island Sunscreen SPF 30 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20130628 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g 10056-706_19074ee2-ff90-4503-a321-cda59d247638 10056-706 HUMAN OTC DRUG Peter Island Baby Sunscreen SPF 50 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 10056-707_fe852b93-a70b-4af4-a0ee-0860a6279f3b 10056-707 HUMAN OTC DRUG Peter Island Ultimate Sheer Dry Touch Sunscreen SPF 70 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20130628 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2.8; 6 g/100g; g/100g; g/100g; g/100g; g/100g 10056-708_118f62aa-85b4-4032-9ce6-0e5ba6c16414 10056-708 HUMAN OTC DRUG PETER ISLAND NATURAL MINERALSPF 60 SPF 60 TITANIUM DIOXIDE ZINC OXIDE LOTION TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC TITANIUM DIOXIDE; ZINC OXIDE 2.8; 4 g/100g; g/100g 10056-709_e24f1373-26a6-4256-a654-418a56a691f2 10056-709 HUMAN OTC DRUG Peter Island Continous sunscreen SPF 50 OXYBENZONE, AVOBENZONE, OCTOCRYLENE SPRAY TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC AVOBENZONE; OCTISALATE; OXYBENZONE 3; 5; 5 g/100g; g/100g; g/100g 10056-710_2c389c71-920b-4711-af22-26eb2cd168e3 10056-710 HUMAN OTC DRUG Peter Island Continous sunscreen kids SPF 50 OXYBENZONE, AVOBENZONE, OCTOCRYLENE SPRAY TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC AVOBENZONE; OCTISALATE; OXYBENZONE 3; 5; 5 g/100g; g/100g; g/100g 10056-711_54a41877-7106-4442-a228-1afd818ca525 10056-711 HUMAN OTC DRUG Peter Island Continous sunscreen SPF 30 OCTOCRYLENE AVOBENZONE OCTISALATE HOMOSALATE LOTION TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; 1/100g; g/100g; g/100g 10056-872_f0ff3c56-5a7a-4aa3-a739-a5f80f458076 10056-872 HUMAN OTC DRUG fulton street market night time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120822 OTC MONOGRAPH FINAL part341 Access Business Group LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 10056-897_9543b652-8d7c-40d2-bd93-e2020f79ce92 10056-897 HUMAN OTC DRUG formu care ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990119 ANDA ANDA074937 Access Business Group LLC IBUPROFEN 100 mg/5mL 10056-903_c324dc52-e35b-4a60-a093-6c7ca5a97726 10056-903 HUMAN OTC DRUG fulton street market cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20100811 OTC MONOGRAPH FINAL part341 Access Business Group LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 10056-915_58e51d07-7378-4fd6-b337-bf7287f62e71 10056-915 HUMAN OTC DRUG formu care omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20090708 NDA NDA022032 Access Business Group LLC OMEPRAZOLE 20 mg/1 10056-964_8c519f9b-5aa4-4a14-8504-f2b1075df3b1 10056-964 HUMAN OTC DRUG formu care flu and severe cold and cough night time Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20100914 OTC MONOGRAPH FINAL part341 Access Business Group International LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 10056-990_1a2fdebc-0659-4216-abab-ce1f345ad0e0 10056-990 HUMAN OTC DRUG Fulton Street Market cold and flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate LIQUID ORAL 20100715 OTC MONOGRAPH FINAL part341 Access Business Group LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 10073-001_97a36b32-86b4-4cce-a33a-277bccc0e4dd 10073-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19640101 UNAPPROVED MEDICAL GAS Ozarc Gas Equipment Supply Inc OXYGEN 992 L/1000L 10073-002_be3167a8-292c-41f2-8a9d-714b5d1ecf42 10073-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19640101 UNAPPROVED MEDICAL GAS Ozarc Gas Equipment Supply Inc OXYGEN 992 L/1000L 10078-001_2ddd561c-aff3-476a-93b8-252b81289dcc 10078-001 HUMAN OTC DRUG MEND AID Antibacterial Adhesive Bandages BENZALKONIUM CHLORIDE PATCH TOPICAL 20111208 OTC MONOGRAPH NOT FINAL part333E Kay's Designs International Limited BENZALKONIUM CHLORIDE .12 mg/100mg 10096-0004_88cc3027-c987-4bb6-8bde-e0266bb26eeb 10096-0004 HUMAN OTC DRUG foot works arthritis achy foot and muscle Methyl Salicylate CREAM TOPICAL 20120530 OTC MONOGRAPH NOT FINAL part348 Avon Products, Inc. METHYL SALICYLATE 18.75 mL/75mL 10096-0038_568ca901-73be-4fef-a1f3-8d0cc004f79e 10096-0038 HUMAN OTC DRUG Beyond Color Plumping Lipcolor OCTINOXATE LIPSTICK TOPICAL 20130209 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE 75 mg/g 10096-0071_954c462b-a2ae-4ff7-9c50-92b7d5cc80bd 10096-0071 HUMAN OTC DRUG Skin So Soft Bug Guard Plus IR3535 Cool N Fabulous Disappearing Color Insect Repellent Sunscreen Octinoxate, Oxybenzone, Octisalate LOTION TOPICAL 20130212 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 60 mg/mL; mg/mL; mg/mL 10096-0081_7adf5769-f5ed-4d2d-86dc-0cdd3e3d8023 10096-0081 HUMAN OTC DRUG On Duty Original Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121116 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 207 mg/mL 10096-0082_5c5e7387-2e56-45bb-b370-3c758c165160 10096-0082 HUMAN OTC DRUG Feelin Fresh Original Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121116 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 207 mg/mL 10096-0103_4bab55b0-44de-4f98-b2ae-a3ee1ccfc0ee 10096-0103 HUMAN OTC DRUG moisture therapy intensive healing and repair lip Octinoxate, Oxybenzone OINTMENT TOPICAL 20120522 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; OXYBENZONE 1.125; .45 mL/15mL; mL/15mL 10096-0121_3c29d5b3-de93-4d66-9654-14a6a3c3b54a 10096-0121 HUMAN OTC DRUG Skin So Soft Bug Guard Plus IR3535 Expedition Insect Repellent Sunscreen Octocrylene, Octinoxate, Oxybenzone, Octisalate SPRAY TOPICAL 20130212 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 75; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL 10096-0138_68267922-2212-4936-a14d-56ce91851543 10096-0138 HUMAN OTC DRUG Anew Age-Transforming Concealer Titanium Dioxide, Octinoxate CREAM TOPICAL 20130209 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; TITANIUM DIOXIDE 25; 66.2 mg/g; mg/g 10096-0144_3bb52643-1d5c-423f-8b4f-b7409f7443b3 10096-0144 HUMAN OTC DRUG mark. For Gooness Face Antioxidant Skin Moisturizing Homosalate, Octinoxate, Octisalate, Oxybenzone, Avobenzone LOTION TOPICAL 20130308 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 80; 75; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10096-0146_2d0a0183-73a9-40a9-87e5-719b6989b434 10096-0146 HUMAN OTC DRUG Moisture Therapy Anti-Itch menthol SPRAY TOPICAL 20120926 OTC MONOGRAPH NOT FINAL part348 Avon Products, Inc. MENTHOL 5 mg/mL 10096-0149_59ab0592-cb79-434c-83b5-7e41efac7394 10096-0149 HUMAN OTC DRUG Anew Rejuvenate 24 hour Eye Moisturizer OCTINOXATE, OCTISALATE, AVOBENZONE, HOMOSALATE CREAM TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 20; 20; 75; 50 mg/mL; mg/mL; mg/mL; mg/mL 10096-0152_898cc617-e642-4d8f-96f5-0eb4c29b503d 10096-0152 HUMAN OTC DRUG Skin So Soft Bug Guard Plus IR3535 Expedition Insect Repellent Sunscreen Octocrylene, Octinoxate, Oxybenzone, Octisalate AEROSOL TOPICAL 20130212 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 68; 45; 90; 54 mg/g; mg/g; mg/g; mg/g 10096-0153_8fd6a82f-087b-4250-9d14-fd2683517241 10096-0153 HUMAN OTC DRUG Skin So Soft Firm and Restore Age Defying Corrective Neck and Chest Octinoxate, Oxybenzone, Octisalate, Avobenzone CREAM TOPICAL 20120417 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 3; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL 10096-0154_106ec01b-10f1-469e-91db-54c7cd33edeb 10096-0154 HUMAN OTC DRUG Clearskin Professional Daily Correcting Salicylic Acid LOTION TOPICAL 20111109 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID 5 mg/mL 10096-0155_247a0a14-9f9c-4744-ba38-390ca89f761f 10096-0155 HUMAN OTC DRUG Clearskin Professional Deep Pore Cleansing Scrub Salicylic Acid GEL TOPICAL 20121111 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID 5 mg/mL 10096-0158_208d37f0-8214-4aa4-88cb-66d7d40d6350 10096-0158 HUMAN OTC DRUG Magix Face Perfector OCTINOXATE, OCTISALATE LOTION TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; OCTISALATE 75; 40 mg/mL; mg/mL 10096-0168_084a9c9c-d070-4b8a-a5af-cde88b052bf1 10096-0168 HUMAN OTC DRUG Solutions A.M. Total Radiance OCTINOXATE, OCTISALATE, AVOBENZONE LOTION TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; OCTINOXATE; OCTISALATE 20; 75; 50 mg/mL; mg/mL; mg/mL 10096-0171_9554a117-bcb6-4731-ba4f-f162245e5024 10096-0171 HUMAN OTC DRUG Anew Age-Transforming Foundation Octinoxate, Titanium Dioxide LOTION TOPICAL 20130209 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; TITANIUM DIOXIDE 75; 40 mg/mL; mg/mL 10096-0173_9a4aa372-2642-4132-9024-4cdb368fe869 10096-0173 HUMAN OTC DRUG mark. get a tint tinted moisturizer Octinoxate, Titanium Dioxide LOTION TOPICAL 20120523 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; TITANIUM DIOXIDE 2.995; 2.905 mL/50mL; mL/50mL 10096-0178_ef0f74ed-7936-4385-ae60-51ab0691f2a6 10096-0178 HUMAN OTC DRUG Solutions Ageless Results Day OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL 10096-0180_a36f28b1-d9f7-4020-b43f-18e20902e095 10096-0180 HUMAN OTC DRUG CLEARSKIN PROFESSIONAL INVISIBLE BLEMISH TREATMENT Salicylic Acid GEL TOPICAL 20091210 OTC MONOGRAPH FINAL part333 Avon Products, Inc. SALICYLIC ACID .3 mL/15mL 10096-0181_efa124d3-d775-4ddf-b7ff-1be2581d72c0 10096-0181 HUMAN OTC DRUG Anew Reversalist Day Renewal OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20091215 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 28.5; 71.1; 47.5; 40 mg/g; mg/g; mg/g; mg/g 10096-0182_dda07418-1783-442b-a9f8-faffd49d867b 10096-0182 HUMAN OTC DRUG Clearskin Blackhead Eliminating Cleanser Salicylic Acid GEL TOPICAL 20091216 OTC MONOGRAPH FINAL part333 Avon Products, Inc. SALICYLIC ACID 2.5 mL/125mL 10096-0183_104763f9-1e49-4be7-8927-300be484023b 10096-0183 HUMAN OTC DRUG Clearskin Blackhead Eliminating Daily Astringent Salicylic Acid LIQUID TOPICAL 20091216 OTC MONOGRAPH FINAL part333 Avon Products, Inc. SALICYLIC ACID 5 mL/250mL 10096-0184_20260945-f4f9-4d13-bdb6-fb56ac8bd40e 10096-0184 HUMAN OTC DRUG Clearskin Blackhead Eliminating Deep Treatment Mask Salicylic Acid PASTE TOPICAL 20091216 OTC MONOGRAPH FINAL part333 Avon Products, Inc. SALICYLIC ACID .375 mL/75mL 10096-0185_5743e24d-cc10-48e4-af7d-e0bdf7b947b8 10096-0185 HUMAN OTC DRUG Clearskin Professional Oil Free OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE LOTION TOPICAL 20091221 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 25; 71.1; 45; 30 mg/mL; mg/mL; mg/mL; mg/mL 10096-0186_db8fe33f-1f5a-41d6-8799-1aaf0355ed16 10096-0186 HUMAN OTC DRUG Clearskin Blemish Clearing Acne Pads Salicylic acid LIQUID TOPICAL 20091221 OTC MONOGRAPH FINAL part333 Avon Products, Inc. SALICYLIC ACID 300 mg/30g 10096-0188_ae64975b-ac6a-45b7-831c-4c003032bcca 10096-0188 HUMAN OTC DRUG Ultra Color Rich Mega Impact OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20091222 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; OXYBENZONE 150; 90 mg/3g; mg/3g 10096-0189_acb0ee1d-4140-4c73-bba8-0a0dde0e587b 10096-0189 HUMAN OTC DRUG magix Cashmere Finish Liquid Foundation Titanium Dioxide LOTION TOPICAL 20091229 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc TITANIUM DIOXIDE 33.9 mg/mL 10096-0191_55c26acc-351a-40d5-b8ab-a80c326a350c 10096-0191 HUMAN OTC DRUG Ultra Color Rich Cool Bliss OCTINOXATE LIPSTICK TOPICAL 20091229 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE 210 mg/3g 10096-0192_3c8a938b-ce64-4fd7-a955-be6ca9ab0731 10096-0192 HUMAN OTC DRUG mark. back up plan Anti-Acne Back Treatment Salicylic Acid SPRAY TOPICAL 20091229 OTC MONOGRAPH FINAL part333 Avon Products, Inc. SALICYLIC ACID 4.72 mL/118mL 10096-0193_a4b058f6-4452-4d8c-9819-dc10fff61aef 10096-0193 HUMAN OTC DRUG True Force Roll-On Antiperspirant Deoderant Aluminum Chlorohydrate GEL TOPICAL 20091229 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL 10096-0194_37626f3a-17af-4bd3-a3d1-b6d42a05c32f 10096-0194 HUMAN OTC DRUG MARK. BLEMISH BANISHER Anti-Acne Body Treatment Pads Salicylic Acid CLOTH TOPICAL 20091229 OTC MONOGRAPH FINAL part333 Avon Products, Inc. SALICYLIC ACID .6 mL/60mL 10096-0195_42816e46-aaec-483d-8e12-2a01051bf501 10096-0195 HUMAN OTC DRUG MARK. Break Out Plan Salicylic Acid GEL TOPICAL 20091229 OTC MONOGRAPH FINAL part333 Avon Products Inc. SALICYLIC ACID .75 mL/50mL 10096-0196_0180ddf0-a656-48ab-8a05-46d5203f6049 10096-0196 HUMAN OTC DRUG Imari Seduction Roll-On Anti-Perspirant Deoderant Aluminum Chlorohydrate GEL TOPICAL 20091229 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL 10096-0199_0c26c839-a5d7-4cd7-82d6-7f4675996daf 10096-0199 HUMAN OTC DRUG Clearskin Pore Penetrating Cleanser TRICLOSAN GEL TOPICAL 20100602 OTC MONOGRAPH NOT FINAL part333 Avon Products, Inc. TRICLOSAN .5 mL/125mL 10096-0200_52d3483c-c276-416f-8229-c3f2f50e2b1d 10096-0200 HUMAN OTC DRUG Clearskin Blemish Clearing Foaming Cleanser Salicylic acid GEL TOPICAL 20100602 OTC MONOGRAPH FINAL part333 Avon Products, Inc. SALICYLIC ACID 2.5 mL/125mL 10096-0201_1a4c6245-bd7f-450d-8d75-b1cbe2974fec 10096-0201 HUMAN OTC DRUG mark Totally Balmed OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE LIPSTICK TOPICAL 20100602 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 84; 294; 199.5; 199.5 mg/4.2g; mg/4.2g; mg/4.2g; mg/4.2g 10096-0203_0f7c7dc1-daf7-4cc0-a875-b26c43056139 10096-0203 HUMAN OTC DRUG mark. save the day Anti-Acne Concealer Salicylic Acid STICK TOPICAL 20100603 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID 36 mg/1.8g 10096-0206_1d0a0ed5-02f6-4d6d-bfb0-a82f805230fb 10096-0206 HUMAN OTC DRUG Solutions Neck and Chest Perfector OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20100607 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/mL; mg/mL; mg/mL; mg/mL 10096-0208_b3d50445-ed92-41ea-9d26-1d88ac61fa4a 10096-0208 HUMAN OTC DRUG Naturals Cucumber and Melon Anti-Bacterial Hand Soap TRICLOSAN LIQUID TOPICAL 20100609 OTC MONOGRAPH FINAL part333 Avon Products, Inc. TRICLOSAN .5 mL/250mL 10096-0209_ff583a28-225c-42a7-82ef-e1b8d2672eb8 10096-0209 HUMAN OTC DRUG Naturals Pomegranate and Mango Anti-Bacterial Hand Soap TRICLOSAN LIQUID TOPICAL 20100609 OTC MONOGRAPH NOT FINAL part333 Avon Products, Inc. TRICLOSAN .5 mL/250mL 10096-0210_027fb56e-34df-4fd2-b074-f2aac20c7716 10096-0210 HUMAN OTC DRUG Far Away Dreams Roll-On Antiperspirant Deoderant Aluminum Chlorohydrate GEL TOPICAL 20100609 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL 10096-0212_10cbc80c-e5f8-468b-b78a-e6f428eea8ac 10096-0212 HUMAN OTC DRUG Naturals Antibacterial Liquid Soap Vanilla TRICLOSAN LIQUID TOPICAL 20100609 OTC MONOGRAPH NOT FINAL part333 Avon Products, Inc. TRICLOSAN .5 mL/250mL 10096-0214_e7e7899a-29af-4410-bfef-a4239477be10 10096-0214 HUMAN OTC DRUG Healthy Makeup Cream-to-Powder Foundation TITANIUM DIOXIDE CREAM TOPICAL 20100609 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. TITANIUM DIOXIDE 765 mg/9g 10096-0215_f2550015-df2c-441a-9a5f-be5c70c2a574 10096-0215 HUMAN OTC DRUG Healthy Makeup Lip Conditioner OCTINOXATE LIPSTICK TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE 225 mg/3g 10096-0216_8ec212b5-92c1-4bda-8ed9-3f5aa44a7dfe 10096-0216 HUMAN OTC DRUG Healthy Makeup OCTINOXATE LIPSTICK TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE 225 mg/3g 10096-0217_2d7176bc-35f2-4365-9bad-1378673c387f 10096-0217 HUMAN OTC DRUG Naturals Vanilla Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20100611 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL 10096-0219_6d951e00-c148-40c6-bdd7-296bdf82a247 10096-0219 HUMAN OTC DRUG Naturals Cucumber Melon Anti-perspirant Deoderant Aluminum Chlorohydrate GEL TOPICAL 20100611 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL 10096-0220_001f9823-68ce-4dcb-bc55-603e6f1a7c68 10096-0220 HUMAN OTC DRUG Advance Techniques Keep Clear Anti-Dandruff Treatment PYRITHIONE ZINC LOTION TOPICAL 20100611 OTC MONOGRAPH FINAL part358 Avon Products, Inc. PYRITHIONE ZINC .15 mL/150mL 10096-0221_92293452-8e03-4327-a710-75e27a780c26 10096-0221 HUMAN OTC DRUG Advance Techniques Keep Clear 2-in-1 Anti-Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20100614 OTC MONOGRAPH FINAL part358H Avon Products, Inc. PYRITHIONE ZINC 10 mg/mL 10096-0223_562eb5ea-4da6-4862-bd39-c54ffedbd89e 10096-0223 HUMAN OTC DRUG Clearskin Blemish Clearing Spot Treatment Salicylic acid GEL TOPICAL 20100614 OTC MONOGRAPH FINAL part333 Avon Products, Inc. SALICYLIC ACID .3 mL/15mL 10096-0224_bf844c3d-e5fc-4583-b582-55c91e2cb187 10096-0224 HUMAN OTC DRUG ANEW Platinum Day OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20100907 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 28.5; 75; 47.5; 40 mg/g; mg/g; mg/g; mg/g 10096-0225_c339de63-696d-4977-87fa-7c59f0a56b74 10096-0225 HUMAN OTC DRUG Rare Diamonds Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20100907 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL 10096-0226_4a74b611-6d04-4298-a1ae-22b047488f0f 10096-0226 HUMAN OTC DRUG Clearskin Professional Clear Pore Thermal Mask Salicylic acid GEL TOPICAL 20100917 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID .375 mL/75mL 10096-0227_5889492c-1505-496f-a7e5-cc2759e30be5 10096-0227 HUMAN OTC DRUG IMARI Mystique Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20100917 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL 10096-0228_f292780e-524a-4a00-b306-db9087e7ce83 10096-0228 HUMAN OTC DRUG Moisture Therapy Ultra Skin Renewal Petrolatum OINTMENT TOPICAL 20100917 OTC MONOGRAPH FINAL part347 Avon Products, Inc. PETROLATUM 60.3 mL/100mL 10096-0229_acc165fb-a26e-4db6-99d1-b22b776ed04f 10096-0229 HUMAN OTC DRUG Ultra Color Rich Moisture Seduction OCTINOXATE LIPSTICK TOPICAL 20101214 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE .225 g/3g 10096-0230_49ecd2ac-1a4a-41ae-8deb-f345d148da7b 10096-0230 HUMAN OTC DRUG Extralasting OCTINOXATE LIPSTICK TOPICAL 20101214 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE .1125 g/1.5g 10096-0231_b1b7ecd3-cd5e-4412-af47-66dce5bd068f 10096-0231 HUMAN OTC DRUG Extralasting Cream-to-Powder Foundation OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20101215 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; TITANIUM DIOXIDE 63.4; 30 mg/g; mg/g 10096-0232_e4e585fb-f89e-47a0-bf16-a820e32d72f4 10096-0232 HUMAN OTC DRUG Extralasting Liquid Foundation TITANIUM DIOXIDE LOTION TOPICAL 20101215 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. TITANIUM DIOXIDE 53.9 mg/mL 10096-0233_b7b49e60-012e-43f5-8738-aba9a6e11b07 10096-0233 HUMAN OTC DRUG Musk Marine Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20101215 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL 10096-0234_fb5d4ccb-1f32-4cd5-a074-1a0102013e2e 10096-0234 HUMAN OTC DRUG mark. Get Treatment Anti-Acne Overnight Treatment Salicylic Acid GEL TOPICAL 20101216 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID .425 mL/25mL 10096-0236_4ba5c6ef-7bcf-4f7a-ae05-e31da847397b 10096-0236 HUMAN OTC DRUG mark. Lipclick SPF 15 Color Shine Octinoxate, Oxybenzone LIPSTICK TOPICAL 20101220 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; OXYBENZONE .15; .09 g/3g; g/3g 10096-0237_5f7394a9-b67b-43ec-b132-26d555cab7ce 10096-0237 HUMAN OTC DRUG mark. Help Wanted Anti-Acne Exfoliating Cleanser Salicylic Acid PASTE TOPICAL 20101220 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID .75 mL/150mL 10096-0238_220d4af4-4397-4a95-be8d-5dd7f4fd57bf 10096-0238 HUMAN OTC DRUG Mommy Tillia Antibacterial Hand ALCOHOL GEL TOPICAL 20101220 OTC MONOGRAPH NOT FINAL part333E Avon Products, Inc. ALCOHOL 153.34 mL/237mL 10096-0241_cf4480fc-662d-40d3-94d4-e1e50559e63a 10096-0241 HUMAN OTC DRUG Anew Solar Advance Eye and Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20101221 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. TITANIUM DIOXIDE; TITANIUM DIOXIDE; ZINC OXIDE; ZINC OXIDE .155; .165; .345; .36 g/5g; g/5g; g/5g; g/5g 10096-0242_fe1fdfa1-6cc5-4b17-98f0-5531d1f8ad03 10096-0242 HUMAN OTC DRUG Tiny Tillia ZINC OXIDE CREAM TOPICAL 20110126 OTC MONOGRAPH FINAL part347 Avon Products, Inc. ZINC OXIDE 10 g/100g 10096-0243_8caa6ec4-78da-46fe-877b-787623fd7fee 10096-0243 HUMAN OTC DRUG On Duty 24 Hours Clear Protection Roll-On Anti-Perspirant Deodorant ALUMINUM ZIRCONIUM PENTACHLOROHYDRATE GEL TOPICAL 20110223 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM ZIRCONIUM PENTACHLOROHYDRATE 5.25 mL/50mL 10096-0249_fb0e485d-e4ce-4d62-b6b2-2454337b11ed 10096-0249 HUMAN OTC DRUG Moisture Therapy Intensive Healing and Repair Body OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 10 mg/mL; mg/mL; mg/mL 10096-0251_087d043b-71e8-4eca-a341-1c15276f128c 10096-0251 HUMAN OTC DRUG Naturals Vanilla Antibacterial Hand Alcohol GEL TOPICAL 20110414 OTC MONOGRAPH NOT FINAL part333E Avon Products, Inc. ALCOHOL 19.428 mL/30mL 10096-0252_e6a0e1c1-7f61-4e86-933b-83f89eae93fb 10096-0252 HUMAN OTC DRUG Naturals Pomegranate and Mango Antibacterial Hand Alcohol GEL TOPICAL 20110414 OTC MONOGRAPH NOT FINAL part333E Avon Products, Inc. ALCOHOL 19.428 mL/30mL 10096-0253_8ff28e8c-7990-4e14-9ef4-b9e33dcfee03 10096-0253 HUMAN OTC DRUG Naturals Cucumber Melon Antibacterial Hand Alcohol GEL TOPICAL 20110414 OTC MONOGRAPH NOT FINAL part333E Avon Products, Inc. ALCOHOL 19.428 mL/30mL 10096-0254_f5a972d7-1350-4aa1-bf3d-f677a828886d 10096-0254 HUMAN OTC DRUG ANEW Solar Advance Sunscreen Body Mist HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE SPRAY TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.275; 12; 11.25; 7.125; 3.84; 7.125 mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL 10096-0255_cfbc6073-9282-4088-ad2c-dfa027e9568c 10096-0255 HUMAN OTC DRUG mark. Get Defensive SPF 15 Eye Octinoxate, Oxybenzone, Octisalate, Avobenzone CREAM TOPICAL 20110414 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE .3; 1.125; .45; .45 mL/15mL; mL/15mL; mL/15mL; mL/15mL 10096-0257_2626340a-330d-476d-9013-c5518c6a044f 10096-0257 HUMAN OTC DRUG Ideal Flawless Invisible Coverage Liquid Foundation Titantium Dioxide LOTION TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc TITANIUM DIOXIDE 25.8 mg/mL 10096-0258_51a7f2c0-fea0-4432-92a4-717f8e9750cb 10096-0258 HUMAN OTC DRUG superSHOCK Liquid Lip Shine OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20110419 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; OXYBENZONE .525; .315 g/10.5g; g/10.5g 10096-0259_1fd95a73-5901-4928-9269-333dee4cb846 10096-0259 HUMAN OTC DRUG Musk Fire Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20110419 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL 10096-0260_df80c035-9e6a-4179-a110-c7d996a4743b 10096-0260 HUMAN OTC DRUG Avon Extralasting Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20110422 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. TITANIUM DIOXIDE; ZINC OXIDE .936; .8232 g/12g; g/12g 10096-0261_50030cc2-75cc-4cef-aee9-f8ae31d1da64 10096-0261 HUMAN OTC DRUG Satin Satisfaction Lip Color OCTINOXATE LIPSTICK TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE .28 g/4g 10096-0262_28cc6760-6dee-406a-8573-a4b18e07ca84 10096-0262 HUMAN OTC DRUG Avon Care Moisture Replenish Daily Hydrating OCTINOXATE, OXYBENZONE CREAM TOPICAL 20110713 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; OXYBENZONE 75; 35 mg/mL; mg/mL 10096-0264_8703eef1-0559-471c-bc70-834965172d13 10096-0264 HUMAN OTC DRUG Clearskin Professional Acne Mark Treatment Salicylic Acid CREAM TOPICAL 20110928 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID 1 mL/50mL 10096-0265_0e22311b-fc82-4244-b50b-5e6335fe8e41 10096-0265 HUMAN OTC DRUG magiX Illuminating Face Perfector Octisalate, Titanium Dioxide CREAM TOPICAL 20111220 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTISALATE; TITANIUM DIOXIDE .9; .657 mL/30mL; mL/30mL 10096-0266_c9edc5e4-b478-4485-9f95-4c25d44c9720 10096-0266 HUMAN OTC DRUG Anew Ultimate 7S Day HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20111220 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYBENZONE 1.425; 4; 2.5; 2 g/50g; g/50g; g/50g; g/50g 10096-0267_0f737667-a96e-4df2-8cc6-877da00dc01c 10096-0267 HUMAN OTC DRUG Clearskin Clear Emergency Intensive Treatment Salicylic Acid GEL TOPICAL 20111220 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID .022 mL/1.1mL 10096-0268_035929e7-51b8-4100-923c-5e4aac0097d9 10096-0268 HUMAN OTC DRUG Far Away Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20120213 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL 10096-0269_43af9639-455c-4e14-807b-14ae414217cd 10096-0269 HUMAN OTC DRUG Rare Gold Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20120213 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL 10096-0271_d407746d-bc25-474e-b76d-a2068ddad0f1 10096-0271 HUMAN OTC DRUG Skin So Soft Soft and Sensual Anti-Perspirant Deodorant ALUMINUM ZIRCONIUM PENTACHLOROHYDRATE GEL TOPICAL 20120402 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM ZIRCONIUM PENTACHLOROHYDRATE 5.25 mL/50mL 10096-0272_7439b818-dab9-499b-ba10-cf698a7fb62b 10096-0272 HUMAN OTC DRUG Foot Works Healthy Antifungal TOLNAFTATE SPRAY TOPICAL 20111219 OTC MONOGRAPH FINAL part333C Avon Products, Inc. TOLNAFTATE 1 mL/100mL 10096-0274_3698b595-b61e-46c5-bef5-0f7ccf7d5847 10096-0274 HUMAN OTC DRUG Skin So Soft Fresh and Smooth Moisturizing Hair Minimizing Anti-Perspirant Deodorant aluminum zirconium pentachlorohydrate GEL TOPICAL 20120417 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM ZIRCONIUM PENTACHLOROHYDRATE 5.25 mL/50mL 10096-0275_cb2145c7-ab58-4022-8a16-3d923c1b8c40 10096-0275 HUMAN OTC DRUG Skin So Soft Original Anti-Perspirant Deodorant aluminum zirconium pentachlorohydrate GEL TOPICAL 20120417 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM ZIRCONIUM PENTACHLOROHYDRATE 5.25 mL/50mL 10096-0276_e55e62c6-811b-4dc8-a62b-5c8ede250f91 10096-0276 HUMAN OTC DRUG clearskin clear emergency instant spot treatment salicylic acid GEL TOPICAL 20120420 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID .3 mL/15mL 10096-0277_7a271cc3-7392-4416-b88f-ff9e889118ae 10096-0277 HUMAN OTC DRUG clearskin clear emergency intensive cream cleanser salicylic acid CREAM TOPICAL 20120420 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID 1.5 mL/75mL 10096-0278_77bf275b-269e-408c-9f86-9fbd822a3e01 10096-0278 HUMAN OTC DRUG clearskin blemish clearing 2-in-1 treatment and hydrator salicylic acid LOTION TOPICAL 20120423 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID .6 mL/30mL 10096-0279_a128c81e-fae3-4793-bae5-f2d06103dc8d 10096-0279 HUMAN OTC DRUG ideal flawless invisible coverage cream to powder foundation Octinoxate, Titanium Dioxide CREAM TOPICAL 20120423 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; TITANIUM DIOXIDE .568; 30.284 g/9g; g/9g 10096-0280_6ab0343a-eebe-4bb2-894a-93b786782a38 10096-0280 HUMAN OTC DRUG Ironman Glory Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20120522 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL 10096-0281_2ee6e6b4-ff29-4b44-9e09-4b62b0a43626 10096-0281 HUMAN OTC DRUG mark got the goods multi-benefit foundation Octinoxate, Titanium Dioxide, Oxybenzone LOTION TOPICAL 20120522 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 2.247; .6; .78 mL/30mL; mL/30mL; mL/30mL 10096-0282_b601fe98-ecf1-47f4-9c80-1a41555d3b48 10096-0282 HUMAN OTC DRUG skin so soft bug guard plusitch relief itch relief menthol SPRAY TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part348 Avon Products, Inc. MENTHOL 5 mg/mL 10096-0284_a63c5612-8ad7-49d0-bea9-57c9a539fd9a 10096-0284 HUMAN OTC DRUG Footworks Maximum Strength Cracked Heel Benzalkonium Chloride, Lidocaine CREAM TOPICAL 20121016 OTC MONOGRAPH FINAL part348 Avon Products, Inc BENZALKONIUM CHLORIDE; LIDOCAINE 1.3; 40 mg/mL; mg/mL 10096-0285_5de25921-a55a-45d6-9d38-6cad6f03cd85 10096-0285 HUMAN OTC DRUG Musk Wood Roll-on Anti-perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121017 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 145 mg/mL 10096-0286_e3f82075-c54f-4ded-ae1b-562849dba2d0 10096-0286 HUMAN OTC DRUG Imari Blossom Roll-on Anti-perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121022 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 145 mg/mL 10096-0287_a11574ea-99d8-4d38-a125-2299bd950ed1 10096-0287 HUMAN OTC DRUG Black Suede Essential Roll-on Anti-perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121022 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 145 mg/mL 10096-0288_6c931508-4c34-4f43-8ece-80c11b58d873 10096-0288 HUMAN OTC DRUG Foot Works Achy Foot Massager Pain Relieving Menthol LOTION TOPICAL 20121025 OTC MONOGRAPH NOT FINAL part348 Avon Products, Inc. MENTHOL 13.5 mg/mL 10096-0289_1d5b4cb0-0bfb-4dce-bf5a-d29a68b66c5f 10096-0289 HUMAN OTC DRUG Clearskin Pore Penetrating Cooling Toner Salicylic Acid LIQUID TOPICAL 20121106 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID 5 mg/mL 10096-0290_bfa767f3-d18c-4cc7-9f85-4dd7a03de331 10096-0290 HUMAN OTC DRUG Anew Clinical Absolute Even Spot Correcting Hand OCTINOXATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20121111 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; OCTINOXATE; OXYBENZONE 20; 75; 40 mg/g; mg/g; mg/g 10096-0291_9baffd63-26a9-4a6e-8e1b-95b02edba76b 10096-0291 HUMAN OTC DRUG Moisture Therapy Daily Skin Defense Body Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130227 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 10 mg/mL; mg/mL; mg/mL 10096-0292_358ea5eb-5b92-4201-8203-d678568bc6b6 10096-0292 HUMAN OTC DRUG Moisture Therapy Intensive Healing and Repair Skin Protectant Petrolatum OINTMENT TOPICAL 20100917 OTC MONOGRAPH FINAL part347 Avon Products, Inc. PETROLATUM 604 mg/mL 10096-0293_054768a6-161b-446a-8e15-d7ea0e5bffe3 10096-0293 HUMAN OTC DRUG Ideal Flawless Beauty Balm Titantium Dioxide CREAM TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc TITANIUM DIOXIDE 54 mg/mL 10096-0294_017eb0fc-896b-44a7-998f-d494e7a844e8 10096-0294 HUMAN OTC DRUG Avon Sun Sunscreen Face Homosalate, Oxybenzone, Octisalate, Avobenzone, Octocrylene LOTION TOPICAL 20130326 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 95; 47.5; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10096-0295_b3743844-d6f9-426c-8da5-b459ee6f5fbc 10096-0295 HUMAN OTC DRUG Avon Sun Sunscreen Homosalate, Oxybenzone, Octisalate, Avobenzone, Octocrylene LOTION TOPICAL 20130326 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 47.5; 25; 47.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10096-0296_f3887122-2ad3-4d53-b32e-d1ac4842f3d3 10096-0296 HUMAN OTC DRUG Avon Sun Sunscreen Homosalate, Octinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene AEROSOL, SPRAY TOPICAL 20130326 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28.5; 80; 75; 47.5; 25.6; 47.5 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g 10096-0297_eb1c82ab-fe5d-45a4-82c8-ef4a9940825d 10096-0297 HUMAN OTC DRUG Clearskin Pore Penetrating Black Mineral Mask Salicylic Acid PASTE TOPICAL 20130327 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID 5 mg/mL 10096-0298_d43b3c91-84e0-44a0-9b88-03e38256b256 10096-0298 HUMAN OTC DRUG mark Glossworks Lip Gloss Octinoxate, Avobenzone, Octisalate LIPSTICK TOPICAL 20130329 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; OCTINOXATE; OCTISALATE 5; 10; 5 mg/g; mg/g; mg/g 10096-0299_046331da-9e85-4ae5-ae7c-735fe1c2a7ae 10096-0299 HUMAN OTC DRUG Avon Elements Youth-Restoring Anti-Wrinkle Moisture Octinoxate, Octisalate, Oxybenzone, Avobenzone CREAM TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 71.2; 47.5; 20 mg/mL; mg/mL; mg/mL; mg/mL 10096-0300_96af0372-de4f-4280-aafc-dbfd9dc5b143 10096-0300 HUMAN OTC DRUG Avon Elements Moisture Boost Daily Moisture Octinoxate, Octisalate, Avobenzone CREAM TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; OCTINOXATE; OCTISALATE 20; 71.1; 47.5 mg/mL; mg/mL; mg/mL 10096-0301_63304796-84f2-424a-8765-6628e2c18246 10096-0301 HUMAN OTC DRUG Avon Elements Moisture Boost Daily Moisture Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; OCTINOXATE; OCTISALATE 28.5; 75; 47.5 mg/mL; mg/mL; mg/mL 10096-0302_32fdc7b7-6e49-43ef-b197-b760d118f4df 10096-0302 HUMAN OTC DRUG Avon Elements Skin Revitalize Instant Radiance Octinoxate, Oxybenzone, Homosalate, Avobenzone LOTION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYBENZONE 25; 30; 75; 35 mg/mL; mg/mL; mg/mL; mg/mL 10096-0303_309d35de-58e1-4bda-b228-2b8022d5d1eb 10096-0303 HUMAN OTC DRUG Foot Works Healthy Antifungal TOLNAFTATE POWDER TOPICAL 20130424 OTC MONOGRAPH FINAL part333C Avon Products, Inc. TOLNAFTATE 10 mg/g 10096-0304_fac4abc6-c905-4e9f-8cce-a1003152eafe 10096-0304 HUMAN OTC DRUG Anew Clinical Skinvincible Multi-Shield Avobenzone, Homosalate, Octinoxate, Octocrylene, Oxybenzone LOTION TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 28; 95; 75; 25.6; 47.5 mg/g; mg/g; mg/g; mg/g; mg/g 10096-0305_05085a6a-6871-42c8-a09d-9daa66b996fc 10096-0305 HUMAN OTC DRUG Anew Rejuvenate Day Revitalizing OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20130209 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 50; 47.5 mg/g; mg/g; mg/g; mg/g 10096-0306_05a61449-137e-47c8-88b4-0e1fc0600fac 10096-0306 HUMAN OTC DRUG Magix Face Perfector OCTINOXATE, OCTISALATE LOTION TOPICAL 20130530 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; OCTISALATE 75; 40 mg/mL; mg/mL 10096-0307_12bb9627-403b-479a-84d4-81986a169982 10096-0307 HUMAN OTC DRUG Ideal Flawless CC Color Corrector Homosalate, Octinoxate, Oxybenzone, Titanium Dioxide, Octocrylene CREAM TOPICAL 20130906 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 70; 70; 20; 47; 21.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10096-0311_84797fe0-5cc6-4959-b895-037b79bdda1b 10096-0311 HUMAN OTC DRUG Anew Reversalist Complete Renewal Day Homosalate, Octinoxate, Oxybenzone, Avobenzone LOTION TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYBENZONE 28.5; 80; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL 10096-0312_2e78d1be-c3b6-4598-bfdf-ec140d4cd470 10096-0312 HUMAN OTC DRUG Anew Reversalist Complete Renewal Day Homosalate, Octinoxate, Oxybenzone, Avobenzone CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYBENZONE 28.5; 70; 70; 40 mg/g; mg/g; mg/g; mg/g 10096-0313_dd2fe6ae-eda2-4277-a609-0d71817216dc 10096-0313 HUMAN OTC DRUG Avon Sun Sport Refresh Sunscreen Homosalate, Oxybenzone, Octisalate, Avobenzone, Octocrylene LOTION TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 95; 47.5; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10096-0314_96d963ba-bd6f-43d5-a20d-10a868f418d5 10096-0314 HUMAN OTC DRUG Avon Sun Sport Refresh Sunscreen Homosalate, Octinoxate, Octisalate, Oxybenzone, Avobenzone LOTION TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 80; 75; 47.5; 45 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10096-0315_3d87fa40-6315-4fa9-9674-5c5c60ac6a01 10096-0315 HUMAN OTC DRUG Avon Sun Sport Refresh Sunscreen Homosalate, Octinoxate, Oxybenzone, Octisalate, Avobenzone LOTION TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 80; 75; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10096-0316_ace216b8-0c37-4564-b7ca-128ff2849ab6 10096-0316 HUMAN OTC DRUG Ideal Flawless Tinted Moisturizer Octinoxate, Titanium Dioxide LOTION TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; TITANIUM DIOXIDE 75; 54 mg/mL; mg/mL 10096-0317_99c1329f-cc28-4d52-be21-72c994e45e87 10096-0317 HUMAN OTC DRUG Skin So Soft DD Body Octisalate, Oxybenzone, Avobenzone, Octocrylene CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 47.5; 25; 40 mg/mL; mg/mL; mg/mL; mg/mL 10096-0318_8d706100-41f0-4949-bee1-4f440a49e484 10096-0318 HUMAN OTC DRUG Avon Elements Youth Restoring Multi-Purpose Homosalate, Octinoxate, Oxybenzone, Avobenzone LOTION TOPICAL 20140317 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYBENZONE 29; 80; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL 10096-0319_6040be7c-117f-4441-8930-b5b940b41870 10096-0319 HUMAN OTC DRUG Anew Vitale Day Octinoxate, Octisalate, Oxybenzone, Avobenzone CREAM TOPICAL 20140317 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 28; 70; 45; 40 mg/g; mg/g; mg/g; mg/g 10096-0320_94aff49f-669e-4bda-8f08-c3b3fa2558d9 10096-0320 HUMAN OTC DRUG Clearskin Blackhead Eliminating Daily Astringent Salicylic Acid LIQUID TOPICAL 20140317 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID 20 mg/mL 10096-0321_5efc67c4-6bd4-4e4c-90d9-1bcfeef41add 10096-0321 HUMAN OTC DRUG Beyond Color Plumping Lip Conditioner OCTINOXATE LIPSTICK TOPICAL 20140926 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE 75 mg/g 10096-0322_276b9263-b6fe-41b0-9506-59fe63729de7 10096-0322 HUMAN OTC DRUG Anew Vitale Day Homosalate, Octinoxate, Oxybenzone, Avobenzone LOTION TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYBENZONE 28.5; 80; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL 10096-0323_8c592881-b9ff-4b31-8b57-927366a35b75 10096-0323 HUMAN OTC DRUG Anew Ultimate Day Multi-Performance Homosalate, Octinoxate, Oxybenzone, Avobenzone CREAM TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYBENZONE 29; 80; 50; 40 mg/g; mg/g; mg/g; mg/g 10096-0324_68ce9375-298c-4ccd-a644-5ac3ed64ed0b 10096-0324 HUMAN OTC DRUG Anew Age-Transforming Foundation Octinoxate, Titanium Dioxide LOTION TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; TITANIUM DIOXIDE 75; 40 mg/mL; mg/mL 10096-0325_2e413d73-0f80-488f-9bdc-304ac999445d 10096-0325 HUMAN OTC DRUG ultra color absolute Octinoxate LIPSTICK TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE 75 mg/g 10096-0868_23294f94-72c5-49e0-960a-96c9f4a927cf 10096-0868 HUMAN OTC DRUG Haiku Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20121114 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 145 mg/mL 10096-4423_d16052fb-5197-4680-b1fa-6dc03084fc53 10096-4423 HUMAN OTC DRUG Foot Works Cracked Heel Lidocaine, BENZALKONIUM CHLORIDE CREAM TOPICAL 20120530 OTC MONOGRAPH FINAL part348 Avon Products, Inc. BENZALKONIUM CHLORIDE; LIDOCAINE .065; 1 mL/50mL; mL/50mL 10096-5214_94767a0b-d968-45e9-8124-45360a31fd43 10096-5214 HUMAN OTC DRUG Cool Confidence Baby Powder Scent Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121111 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 207 mg/mL 10096-5218_38051f60-a213-46e0-afa6-c4344579fb1d 10096-5218 HUMAN OTC DRUG On Duty Sport Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121116 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 207 mg/mL 10096-5219_0487efdf-515c-4218-9ff8-6375b94faa4e 10096-5219 HUMAN OTC DRUG On Duty Unscented Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121116 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 207 mg/mL 10096-7817_a498e3dc-48cf-4610-a1b2-4c3ae862e938 10096-7817 HUMAN OTC DRUG Mesmerize for Men Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20121114 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 145 mg/mL 10096-8026_2ac69725-5eea-41bf-9d1a-e24651e76f8c 10096-8026 HUMAN OTC DRUG Skin So Soft Bug Guard Plus IR3535 Gentle Breeze Insect Repellent Sunscreen Octinoxate, Oxybenzone, Octisalate LOTION TOPICAL 20130212 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 60 mg/mL; mg/mL; mg/mL 10096-8811_bf7ddce3-df77-4b67-aca8-667b00f4e6cf 10096-8811 HUMAN OTC DRUG Cool Confidence Original Scent Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121111 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 207 mg/mL 10096-9182_0908721e-3ab8-42b4-a312-cb5bff4e11a4 10096-9182 HUMAN OTC DRUG Black Suede Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20110128 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL 10096-9298_a7e5307b-ce64-43ee-aa1c-432dd6be8a9c 10096-9298 HUMAN OTC DRUG Wild Country Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20121114 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 145 mg/mL 10096-9357_f23b7e56-61f6-4104-b8a8-fbf756c80acb 10096-9357 HUMAN OTC DRUG Sweet Honesty Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121112 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 145 mg/mL 10096-9360_50745553-fe68-4bc8-84e4-341f49f500ba 10096-9360 HUMAN OTC DRUG Odyssey Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121112 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 145 mg/mL 10096-9363_7e6d272f-4f4d-492c-aa14-435babd65b41 10096-9363 HUMAN OTC DRUG Candid Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121112 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 145 mg/mL 10096-9468_be557436-2cac-4c31-be10-b720ec0c7a32 10096-9468 HUMAN OTC DRUG Night Magic Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121112 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 145 mg/mL 10096-9475_8cd01933-7003-41c7-a60d-5d3b25044a5a 10096-9475 HUMAN OTC DRUG Imari Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20121114 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 145 mg/mL 10096-9488_71b3b455-5813-4d93-acb0-fd8f80a50730 10096-9488 HUMAN OTC DRUG Timeless Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121112 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 145 mg/mL 10100-117_f5babfb8-9c58-4ece-9bea-34103f864483 10100-117 HUMAN OTC DRUG Lil Goats Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20111216 OTC MONOGRAPH FINAL part347 Canus Vermont LLC ZINC OXIDE 113.6 g/284g 10100-119_d49d434c-73fe-42d8-9b06-a3bec3457e5c 10100-119 HUMAN OTC DRUG Lil Goats Zinc Oxide Zinc Oxide CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part347 Canus Vermont LLC PETROLATUM; ZINC OXIDE 49.5; 40 g/142g; g/142g 10109-1234_c9c395e1-b240-4d6c-987c-ba42915a6e30 10109-1234 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20040101 UNAPPROVED MEDICAL GAS ACS Medical LLC OXYGEN 99 L/100L 10122-313_a63732b2-a78f-4549-bfee-d6a7a43af44d 10122-313 HUMAN PRESCRIPTION DRUG Cardene IV nicardipine hydrochloride INJECTION, SOLUTION INTRAVENOUS 19920130 NDA NDA019734 Chiesi USA, Inc. NICARDIPINE HYDROCHLORIDE .1 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 10122-314_a63732b2-a78f-4549-bfee-d6a7a43af44d 10122-314 HUMAN PRESCRIPTION DRUG Cardene IV nicardipine hydrochloride INJECTION, SOLUTION INTRAVENOUS 19920130 NDA NDA019734 Chiesi USA, Inc. NICARDIPINE HYDROCHLORIDE .1 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 10122-321_061a8b75-39c2-4395-960c-49e0fcd25b66 10122-321 HUMAN PRESCRIPTION DRUG FACTIVE gemifloxacin mesylate TABLET ORAL 20030404 NDA NDA021158 Cornerstone Therapeutics Inc. GEMIFLOXACIN MESYLATE 320 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 10122-325_4a768077-d1ba-4d48-bf61-142c15d283bd 10122-325 HUMAN PRESCRIPTION DRUG Cardene IV nicardipine hydrochloride INJECTION, SOLUTION INTRAVENOUS 19920130 NDA NDA019734 Chiesi USA, Inc. NICARDIPINE HYDROCHLORIDE .2 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 10122-326_4a768077-d1ba-4d48-bf61-142c15d283bd 10122-326 HUMAN PRESCRIPTION DRUG Cardene IV nicardipine hydrochloride INJECTION, SOLUTION INTRAVENOUS 19920130 NDA NDA019734 Chiesi USA, Inc. NICARDIPINE HYDROCHLORIDE .2 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 10122-510_74769d15-ca1c-4cf7-baa0-7f8819f29193 10122-510 HUMAN PRESCRIPTION DRUG Curosurf poractant alfa SUSPENSION ENDOTRACHEAL 19991118 NDA NDA020744 Chiesi USA, Inc. PORACTANT ALFA 80 mg/mL Alveolar Surface Tension Reduction [PE],Surfactant [EPC],Surfactant Activity [MoA] 10122-820_139178f6-b766-4622-b270-5b8540c4cf44 10122-820 HUMAN PRESCRIPTION DRUG BETHKIS tobramycin SOLUTION RESPIRATORY (INHALATION) 20130415 NDA NDA201820 Cornerstone Therapeutics Inc. TOBRAMYCIN 300 mg/4mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 10122-901_ae7636e5-0770-4e81-aba8-6f658067710c 10122-901 HUMAN PRESCRIPTION DRUG ZYFLO zileuton TABLET ORAL 19961206 NDA NDA020471 Cornerstone Therapeutics Inc. ZILEUTON 600 mg/1 5-Lipoxygenase Inhibitor [EPC],5-Lipoxygenase Inhibitors [MoA],Decreased Leukotriene Production [PE] 10122-902_ee041d32-b5d6-4774-8431-2ed6f8c9b05b 10122-902 HUMAN PRESCRIPTION DRUG ZYFLO CR zileuton TABLET, MULTILAYER, EXTENDED RELEASE ORAL 20070530 NDA NDA022052 Chiesi USA, Inc. ZILEUTON 600 mg/1 5-Lipoxygenase Inhibitor [EPC],5-Lipoxygenase Inhibitors [MoA],Decreased Leukotriene Production [PE] 10135-492_e44a7e8d-c493-46cd-b2cd-fd515a62fda5 10135-492 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20070401 UNAPPROVED DRUG OTHER Marlex Pharmaceuticals Inc SALSALATE 500 mg/1 10135-493_e44a7e8d-c493-46cd-b2cd-fd515a62fda5 10135-493 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20070401 UNAPPROVED DRUG OTHER Marlex Pharmaceuticals Inc SALSALATE 750 mg/1 10135-541_3c246752-b856-470e-80c2-34731d535cec 10135-541 HUMAN PRESCRIPTION DRUG Probenecid Probenecid TABLET, FILM COATED ORAL 19760729 ANDA ANDA080966 Marlex Pharmaceuticals Inc PROBENECID 500 mg/1 10139-025_9204cff9-51f2-4b0c-b1cc-b06df7bb5f43 10139-025 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070806 ANDA ANDA078277 GeneraMedix Inc. FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 10139-063_9c6e91de-7749-4ccd-8bb2-97d143082fd8 10139-063 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20120830 ANDA ANDA040743 GeneraMedix FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 10139-070_5840504e-2c4c-4fad-9557-9d11e1fbb813 10139-070 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SUSPENSION INTRAMUSCULAR; INTRAVENOUS 20110930 ANDA ANDA065316 GeneraMedix Inc. AMPICILLIN SODIUM; SULBACTAM SODIUM 250; 125 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 10139-071_5840504e-2c4c-4fad-9557-9d11e1fbb813 10139-071 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SUSPENSION INTRAMUSCULAR; INTRAVENOUS 20110930 ANDA ANDA065316 GeneraMedix Inc. AMPICILLIN SODIUM; SULBACTAM SODIUM 250; 125 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 10139-321_e77d77f3-3e96-4ff3-a42d-8bd67dfcf58b 10139-321 HUMAN PRESCRIPTION DRUG Melphalan Hydrochloride Melphalan Hydrochloride KIT 20091027 ANDA ANDA090299 GeneraMedix Inc. 10139-700_5109576e-4242-42e5-8d09-527389ac1325 10139-700 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION INTRAVENOUS 20091118 ANDA ANDA090664 GeneraMedix Inc. NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 10139-705_2c833457-0409-4fb8-9363-d465bc5ee2fe 10139-705 HUMAN PRESCRIPTION DRUG Ibutilide Fumarate Ibutilide Fumarate INJECTION, SOLUTION INTRAVENOUS 20100112 ANDA ANDA090924 GeneraMedix Inc. IBUTILIDE FUMARATE .1 mg/mL Antiarrhythmic [EPC] 10139-905_1f05acc6-f01f-45e6-8578-7eb04a47159b 10139-905 HUMAN PRESCRIPTION DRUG Cosyntropin Cosyntropin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091218 ANDA ANDA090574 GeneraMedix COSYNTROPIN .25 mg/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] 10144-427_ef04ce09-921e-4c24-afa5-3f1f483204fb 10144-427 HUMAN PRESCRIPTION DRUG AMPYRA Dalfampridine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100301 NDA NDA022250 Acorda Therapeutics, Inc. DALFAMPRIDINE 10 mg/1 10144-594_e6d660dc-aeec-4242-a393-4a352449545c 10144-594 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride TABLET ORAL 19970101 NDA NDA020397 Acorda Therapeutics, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 10144-602_e6d660dc-aeec-4242-a393-4a352449545c 10144-602 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride CAPSULE ORAL 20050404 NDA NDA021447 Acorda Therapeutics, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 10144-604_e6d660dc-aeec-4242-a393-4a352449545c 10144-604 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride CAPSULE ORAL 20050404 NDA NDA021447 Acorda Therapeutics, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 10144-606_e6d660dc-aeec-4242-a393-4a352449545c 10144-606 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride CAPSULE ORAL 20050404 NDA NDA021447 Acorda Therapeutics, Inc. TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 10144-928_004a7b0e-8564-4f7b-b7bb-13ff5ef72af8 10144-928 HUMAN PRESCRIPTION DRUG Qutenza capsaicin KIT 20130812 NDA NDA022395 Acorda Therapeutics, Inc. 10144-929_004a7b0e-8564-4f7b-b7bb-13ff5ef72af8 10144-929 HUMAN PRESCRIPTION DRUG Qutenza capsaicin KIT 20130812 NDA NDA022395 Acorda Therapeutics, Inc. 10147-0750_1604db32-d3f4-42fd-ab8c-1284a7a5603e 10147-0750 HUMAN PRESCRIPTION DRUG KETOCONAZOLE ketoconazole SHAMPOO TOPICAL 20050701 NDA AUTHORIZED GENERIC NDA019927 Patriot Pharmaceuticals, LLC KETOCONAZOLE 20 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 10147-0881_da7f9ccc-739a-4529-9e45-44e38c05aaea 10147-0881 HUMAN PRESCRIPTION DRUG galantamine hydrobromide galantamine hydrobromide TABLET, FILM COATED ORAL 20010228 NDA NDA021169 Patriot Pharmaceuticals, LLC GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 10147-0882_da7f9ccc-739a-4529-9e45-44e38c05aaea 10147-0882 HUMAN PRESCRIPTION DRUG galantamine hydrobromide galantamine hydrobromide TABLET, FILM COATED ORAL 20010228 NDA NDA021169 Patriot Pharmaceuticals, LLC GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 10147-0883_da7f9ccc-739a-4529-9e45-44e38c05aaea 10147-0883 HUMAN PRESCRIPTION DRUG galantamine hydrobromide galantamine hydrobromide TABLET, FILM COATED ORAL 20010228 NDA NDA021169 Patriot Pharmaceuticals, LLC GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 10147-0891_da7f9ccc-739a-4529-9e45-44e38c05aaea 10147-0891 HUMAN PRESCRIPTION DRUG galantamine hydrobromide galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20041222 NDA NDA021615 Patriot Pharmaceuticals, LLC GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 10147-0892_da7f9ccc-739a-4529-9e45-44e38c05aaea 10147-0892 HUMAN PRESCRIPTION DRUG galantamine hydrobromide galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20041222 NDA NDA021615 Patriot Pharmaceuticals, LLC GALANTAMINE HYDROBROMIDE 16 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 10147-0893_da7f9ccc-739a-4529-9e45-44e38c05aaea 10147-0893 HUMAN PRESCRIPTION DRUG galantamine hydrobromide galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20041222 NDA NDA021615 Patriot Pharmaceuticals, LLC GALANTAMINE HYDROBROMIDE 24 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 10147-0901_0020cbae-5262-4ac5-8045-4713cc7cabcc 10147-0901 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060116 NDA NDA021692 Patriot Pharmaceuticals, LLC TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 10147-0902_0020cbae-5262-4ac5-8045-4713cc7cabcc 10147-0902 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060116 NDA NDA021692 Patriot Pharmaceuticals, LLC TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 10147-0903_0020cbae-5262-4ac5-8045-4713cc7cabcc 10147-0903 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060116 NDA NDA021692 Patriot Pharmaceuticals, LLC TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 10147-0911_221f2754-b75c-11e2-ac87-48796188709b 10147-0911 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol INJECTION INTRAMUSCULAR 20110617 NDA AUTHORIZED GENERIC NDA015923 Patriot Pharmaceuticals LLC HALOPERIDOL 5 mg/mL Typical Antipsychotic [EPC] 10147-0921_ca158926-cca9-4c88-96f9-765bf4411d96 10147-0921 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20110617 NDA AUTHORIZED GENERIC NDA018701 Patriot Pharmaceuticals LLC HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] 10147-0922_ca158926-cca9-4c88-96f9-765bf4411d96 10147-0922 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20110617 NDA AUTHORIZED GENERIC NDA018701 Patriot Pharmaceuticals LLC HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] 10147-0941_7fd852ab-39f3-4c95-bb6e-84c93577debd 10147-0941 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin SOLUTION ORAL 20130701 NDA AUTHORIZED GENERIC NDA021721 Patriot Pharmaceuticals, Inc. LEVOFLOXACIN 25 mg/mL 10147-1700_0dca070e-e0f1-4dc6-b01d-dbd07b06b3d1 10147-1700 HUMAN PRESCRIPTION DRUG itraconazole ITRACONAZOLE CAPSULE ORAL 20050201 NDA NDA020083 Patriot Pharmaceuticals ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 10157-1006_d5c84ce1-b166-454e-94af-dddf79b08247 10157-1006 HUMAN OTC DRUG Stridex Maximum Salicylic Acid LIQUID TOPICAL 20121201 OTC MONOGRAPH FINAL part333D Blistex Inc SALICYLIC ACID 2 g/100mL 10157-1007_facaed27-a380-4764-9a53-c0279844b22f 10157-1007 HUMAN OTC DRUG Stridex Sensitive Salicylic Acid LIQUID TOPICAL 20121201 OTC MONOGRAPH FINAL part333D Blistex Inc SALICYLIC ACID .5 g/100mL 10157-1010_07b69b4f-e710-427e-890f-ff4a3cd3259d 10157-1010 HUMAN OTC DRUG Stridex Essential Salicylic Acid LIQUID TOPICAL 20121201 OTC MONOGRAPH FINAL part333D Blistex Inc SALICYLIC ACID 1 g/100mL 10157-1042_d0953407-9274-4f98-af74-c1704a425a7b 10157-1042 HUMAN OTC DRUG Stridex Conditioning Acne Scrub Salicylic Acid GEL TOPICAL 20121231 OTC MONOGRAPH FINAL part333D Blistex Inc SALICYLIC ACID 2 g/100mL 10157-1070_eb9d76fe-ae97-4cf4-9efe-95613109df1b 10157-1070 HUMAN OTC DRUG STRIDEX Naturally Clear Stridex naturally clear LIQUID TOPICAL 20091123 OTC MONOGRAPH FINAL part333 Blistex inc SALICYLIC ACID .1 g/1 10157-4645_e629b2da-2c0b-41a4-a45e-780890e07fcf 10157-4645 HUMAN OTC DRUG Blistex Odor-Eaters Powder Tolnaftate SPRAY TOPICAL 20131209 OTC MONOGRAPH FINAL part333C Blistex Inc TOLNAFTATE 1 g/100g 10157-8008_c4e81536-9e92-48cf-9e69-8cdf57ec2b37 10157-8008 HUMAN OTC DRUG Blistex Orange Mango Blast Dimethicone, Octinoxate, and Oxybenzone STICK TOPICAL 20140214 OTC MONOGRAPH FINAL part347 Blistex Inc. DIMETHICONE; OCTINOXATE; OXYBENZONE 1; 7.5; 2.5 g/100g; g/100g; g/100g 10157-8009_b1492fa2-6f92-4bf8-8270-e5b01d5217af 10157-8009 HUMAN OTC DRUG Fruit Smoothies Dimethicone, Octinoxate, and Oxybenzone KIT 20130901 OTC MONOGRAPH FINAL part347 Blistex Inc. 10157-8010_7107e665-a422-4711-bd67-01b0d082c5cd 10157-8010 HUMAN OTC DRUG Fruit Smoothies Dimethicone, Octinoxate, and Oxybenzone KIT 20130901 OTC MONOGRAPH FINAL part347 Blistex Inc. 10157-8012_a883fdbb-b812-4e85-b24f-81e861430683 10157-8012 HUMAN OTC DRUG Fruit Smoothies Dimethicone, Octinoxate, and Oxybenzone KIT 20130901 OTC MONOGRAPH FINAL part347 Blistex Inc. 10157-8013_e6d98c13-2069-4777-82a0-a92d17ffb466 10157-8013 HUMAN OTC DRUG Fruit Smoothies Dimethicone, Octinoxate, and Oxybenzone KIT 20130901 OTC MONOGRAPH FINAL part347 Blistex Inc. 10157-8014_8a58af07-0eaa-4522-b8f1-a5ee7ae7d530 10157-8014 HUMAN OTC DRUG Fruit Smoothies Dimethicone, Octinoxate, and Oxybenzone KIT 20140701 OTC MONOGRAPH FINAL part347 Blistex Inc. 10157-8015_07932d6e-8b02-4207-b680-f0a008693c65 10157-8015 HUMAN OTC DRUG Blistex Ultra Rich Hydration Octinoxate, Oxybenzone, and Dimethicone STICK TOPICAL 20140530 OTC MONOGRAPH FINAL part347 Blistex Inc. DIMETHICONE; OCTINOXATE; OXYBENZONE 2; 6.8; 3 g/100g; g/100g; g/100g 10157-9012_c88c222a-c422-45e1-8617-8f938051a1a5 10157-9012 HUMAN OTC DRUG Blistex Ivarest Medicated Poison Ivy Cleansing Foam Menthol SOAP TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part348 Blistex Inc MENTHOL 1 g/100mL 10157-9077_10c5d833-2e0b-424e-9bb8-856cf40c3ca0 10157-9077 HUMAN OTC DRUG Ivarest Zinc Oxide, Benzyl Alcohol, and Diphenhydramine Hydrochloride CREAM TOPICAL 20071231 OTC MONOGRAPH FINAL part347 Blistex Inc BENZYL ALCOHOL; DIPHENHYDRAMINE HYDROCHLORIDE; ZINC OXIDE 10.5; 2; 14 g/100g; g/100g; g/100g 10157-9302_92221876-9721-4d46-ab79-1bc79d99fee9 10157-9302 HUMAN OTC DRUG Blistex Foille Medicated First Aid Benzocaine and Chloroxylenol OINTMENT TOPICAL 20130305 OTC MONOGRAPH NOT FINAL part348 Blistex Inc. BENZOCAINE; CHLOROXYLENOL 5; .1 g/100g; g/100g 10157-9477_8175b23b-e3c5-47c0-867a-38368d2ae84c 10157-9477 HUMAN OTC DRUG Kank-A Mouth Pain Benzocaine LIQUID BUCCAL 20111201 OTC MONOGRAPH FINAL part346 Blistex Inc. BENZOCAINE 200 mg/mL 10157-9493_407edd7d-5c54-4120-856b-c6e0e9891a67 10157-9493 HUMAN OTC DRUG KANKA SoftBrush Benzocaine and Zinc Chloride GEL ORAL 20090501 OTC MONOGRAPH NOT FINAL part356 Blistex Inc. BENZOCAINE; ZINC CHLORIDE 20; .1 mL/100g; g/100g 10157-9535_5be791fc-5bae-46e8-a7d4-99e84de3a087 10157-9535 HUMAN OTC DRUG Blistex Daily Conditioning Treatment Petrolatum, Octinoxate, and Oxybenzone PASTE TOPICAL 20140214 OTC MONOGRAPH FINAL part347 Blistex Inc. OCTINOXATE; OXYBENZONE; PETROLATUM 7.3; 4.5; 54.86 g/100g; g/100g; g/100g 10157-9539_374e1e4e-e5c2-4089-a86c-a86ed39d67c9 10157-9539 HUMAN OTC DRUG Blistex European Formula Lanolin, Octinoxate, and Oxybenzone PASTE TOPICAL 20110701 OTC MONOGRAPH FINAL part352 Blistex Inc. LANOLIN; OCTINOXATE; OXYBENZONE 13; 7.5; 2.5 g/100g; g/100g; g/100g 10157-9608_97e6706e-e3cf-4a80-b873-36d61c13ccbb 10157-9608 HUMAN OTC DRUG Blistex Medicated Mint Lip Balm Dimethicone, Oxybenzone, and Padimate O STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part347 Blistex Inc. DIMETHICONE; OXYBENZONE; PADIMATE O 2; 2.5; 6.6 g/100g; g/100g; g/100g 10157-9713_0b49344c-a36c-44ed-8ee1-222f6b260f92 10157-9713 HUMAN OTC DRUG Blistex Medicated Berry Balm Dimethicone, Padimate O, and Oxybenzone STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part352 Blistex Inc DIMETHICONE; OXYBENZONE; PADIMATE O 2; 2.5; 6.6 g/100g; g/100g; g/100g 10157-9800_dc72ce14-fe53-427a-b293-de9e03c20501 10157-9800 HUMAN OTC DRUG Blistex Raspberry Lemonade Blast Dimethicone, Octinoxate, and Oxybenzone STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part352 Blistex Inc DIMETHICONE; OCTINOXATE; OXYBENZONE 1; 7.5; 2.5 g/100g; g/100g; g/100g 10157-9822_377a8067-847a-42cc-b504-2cd07e95a936 10157-9822 HUMAN OTC DRUG Blistex Medicated Lip Balm Dimethicone, Oxybenzone, and Padimate O STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part347 Blistex Inc. DIMETHICONE; OXYBENZONE; PADIMATE O 2; 2.5; 6.6 g/100g; g/100g; g/100g 10157-9825_d143602c-e404-4b9d-9401-458a1d395076 10157-9825 HUMAN OTC DRUG Blistex FIVE STAR Lip Protection STICK TOPICAL 20100501 OTC MONOGRAPH FINAL part347 Blistex Inc HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; PETROLATUM 9.6; 7.5; 5; 5; 30.1 g/1; g/1; g/1; g/1; g/1 10157-9826_c30bc026-884c-4ded-9798-07390a44cdb9 10157-9826 HUMAN OTC DRUG Blistex Nurture and Nourish Octinoxate, Oxybenzone, and Dimethicone STICK TOPICAL 20130531 OTC MONOGRAPH FINAL part347 Blistex Inc. DIMETHICONE; OCTINOXATE; OXYBENZONE 2; 7.5; 2.5 g/100g; g/100g; g/100g 10157-9831_4365e238-9de4-4d27-98ce-c684f33b61bd 10157-9831 HUMAN OTC DRUG Blistex Lip Vibrance Octinoxate, Oxybenzone, and Dimethicone STICK TOPICAL 20130531 OTC MONOGRAPH FINAL part347 Blistex Inc. DIMETHICONE; OCTINOXATE; OXYBENZONE 2; 7.5; 2.5 g/100g; g/100g; g/100g 10157-9835_ef7cf65e-848d-48bc-b2be-bc4a10715760 10157-9835 HUMAN OTC DRUG Deep Renewal Avobenzone, Octinoxate, Octocrylene, Oxybenzone, and Dimethicone STICK TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Blistex Inc AVOBENZONE; DIMETHICONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3; 2; 7.5; 2.7; 2.5 g/100g; g/100g; g/100g; g/100g; g/100g 10157-9842_1691897f-405d-4738-abb7-dafaffb2f066 10157-9842 HUMAN OTC DRUG Blistex Five Star Lip Protection Broad Spectrum Octinoxate, Oxybenzone, Dimethicone, Octisalate, Homosalate, Avobenzone, and Octocrylene STICK TOPICAL 20130415 OTC MONOGRAPH FINAL part347 Blistex Inc. AVOBENZONE; DIMETHICONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 2; 4.5; 7.5; 5; 2.7; 6 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 10157-9848_28606dc7-5e71-49ce-84ae-5cc90249c18a 10157-9848 HUMAN OTC DRUG Blistex Revive and Restore Dimethicone, Octinoxate, Oxybenzone, and Lanolin KIT 20110613 OTC MONOGRAPH FINAL part352 Blistex Inc. 10157-9858_78ad38e1-bf7d-43dd-8c57-e37864ce7334 10157-9858 HUMAN OTC DRUG Blistex Enhancement Series Dimethicone, Octinoxate, Oxybenzone, Avobenzone, and Octocrylene KIT 20140515 OTC MONOGRAPH FINAL part347 Blistex Inc. 10157-9860_20506778-89f2-4641-ab94-a4d9a3744b98 10157-9860 HUMAN OTC DRUG Blistex Cold and Allergy Lip Soother Dimethicone and Pramoxine Hydrochloride STICK TOPICAL 20110701 OTC MONOGRAPH FINAL part347 Blistex Inc DIMETHICONE; PRAMOXINE HYDROCHLORIDE 2; 1 g/100g; g/100g 10157-9861_1ca96f35-dd94-4839-8985-76c0fe6b9b38 10157-9861 HUMAN OTC DRUG Blistex Enhancement Series (Lip Vibrance, Deep Renewal and Ultra-Rich Hydration) Dimethicone, Octinoxate, Oxybenzone, Avobenzone, and Octocrylene KIT 20140901 OTC MONOGRAPH FINAL part347 Blistex Inc. 10157-9868_efa038bb-8a42-440a-bd74-4351ed77d071 10157-9868 HUMAN OTC DRUG Blistex Herbal Answer Octinoxate, Oxybenzone, and petrolatum STICK TOPICAL 19990601 OTC MONOGRAPH FINAL part347 Blistex Inc. OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 2.5; 43 g/100g; g/100g; g/100g 10157-9875_81639730-91a5-4631-8eed-f94dea37d21d 10157-9875 HUMAN OTC DRUG Blistex Lip Massage Blistex Lip Massage GEL TOPICAL 20091215 OTC MONOGRAPH FINAL part352 Blistex Inc AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE; PETROLATUM 3; 7.5; 2.7; 2.5; 43.33 g/1; g/1; g/1; g/1; g/1 10157-9877_223035cd-996b-4645-9889-4cf8234b93a9 10157-9877 HUMAN OTC DRUG Blistex Complete Moisture Octinoxate, Oxybenzone, and Dimethicone STICK TOPICAL 20030305 OTC MONOGRAPH FINAL part347 Blistex Inc. DIMETHICONE; OCTINOXATE; OXYBENZONE 2; 7.5; 2.5 g/100g; g/100g; g/100g 10157-9882_9b06adb6-9147-4183-ae9b-93c1cfb81179 10157-9882 HUMAN OTC DRUG Silk and Shine Dimethicone, Octinoxate, and Oxybenzone STICK TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Blistex Inc DIMETHICONE; OCTINOXATE; OXYBENZONE 2; 7.5; 2.5 g/100g; g/100g; g/100g 10157-9883_73563d35-3cbd-49b1-810d-87a09ce849ef 10157-9883 HUMAN OTC DRUG Fruit Smoothies Dimethicone, Octinoxate, and Oxybenzone KIT 20130614 OTC MONOGRAPH FINAL part347 Blistex Inc. 10157-9883_9c9521cb-2296-4468-8213-ca0a50b6ed1a 10157-9883 HUMAN OTC DRUG Fruit Smoothies Dimethicone, Octinoxate, and Oxybenzone KIT 20120601 OTC MONOGRAPH FINAL part347 Blistex Inc. 10157-9951_c5c1e928-a838-4667-9914-438c24bb1a01 10157-9951 HUMAN OTC DRUG Blistex Medicated Dimethicone, Camphor (synthetic), Menthol, and Phenol OINTMENT TOPICAL 20001201 OTC MONOGRAPH NOT FINAL part348 Blistex Inc. CAMPHOR (SYNTHETIC); DIMETHICONE; MENTHOL; PHENOL .5; 1.1; .625; .5 g/100g; g/100g; g/100g; g/100g 10157-9955_5ba87baa-5a03-4297-a245-e1d426eda7b4 10157-9955 HUMAN OTC DRUG Moisture Melt Octinoxate, Oxybenzone, and Petrolatum GEL TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Blistex Inc OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 2.5; 31.7 g/100g; g/100g; g/100g 10158-001_338c2fd7-9199-44bf-b207-c176b0a8bbff 10158-001 HUMAN OTC DRUG Goodys acetaminophen, aspirin, and caffeine POWDER ORAL 20101208 20151231 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare LP ACETAMINOPHEN; ASPIRIN; CAFFEINE 260; 520; 32.5 mg/1; mg/1; mg/1 10158-043_ed79e31b-8e07-48ec-8eab-b0260e930bad 10158-043 HUMAN OTC DRUG Nytol QuickCaps diphenhydramine HCl TABLET, FILM COATED ORAL 20110812 20170930 OTC MONOGRAPH FINAL part338 GlaxoSmithKline consumer Healthcare LP DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 10158-085_b9ba53fb-3584-4d17-8645-fd4e67bf186c 10158-085 HUMAN OTC DRUG Sensodyne Tartar Control potassium nitrate and sodium fluoride PASTE DENTAL 20110608 20160630 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 10158-985_b9ba53fb-3584-4d17-8645-fd4e67bf186c 10158-985 HUMAN OTC DRUG Sensodyne Full Protection potassium nitrate and sodium fluoride PASTE DENTAL 20110608 20151231 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare LP POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g 10163-0202_1f4aed11-6fbc-4e8a-8363-b4a2334d3233 10163-0202 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040810 UNAPPROVED MEDICAL GAS Quality Home Medical, Inc. OXYGEN 99 L/100L 10167-100_9d16ab39-6f97-4d12-b3de-fd9890502eae 10167-100 HUMAN PRESCRIPTION DRUG OXYGEN 0XYGEN GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS Air Source Industries Inc OXYGEN 99 L/100L 10167-200_a78f34d2-9571-482c-b495-b76c5efa8362 10167-200 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS Air Source Industries Inc NITROUS OXIDE 99 L/100L 10167-300_c8afd333-d689-47bb-a635-e7484a20c6c0 10167-300 HUMAN PRESCRIPTION DRUG HELIUM HELIUM GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS Air Source Industries Inc HELIUM 99 L/100L 10167-400_c155ee73-e67f-4e5e-89a5-f54f0787d2ef 10167-400 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS Air Source Industries Inc NITROGEN 99 L/100L 10167-500_7c576308-42c1-41a0-85f7-9bf394165ad8 10167-500 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS Air Source Industries Inc CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 10167-600_06a3c849-c457-487e-b87b-50656dc9a7b5 10167-600 HUMAN PRESCRIPTION DRUG AIR COMPRESSED AIR COMPRESSED GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS Air Source Industries Inc OXYGEN 20 L/100L 10188-001_2b115f8a-d617-47b2-843b-88708f4d615a 10188-001 HUMAN OTC DRUG LifeStyles EPIC Male Genital Desensitizer LIDOCAINE SPRAY TOPICAL 20111102 OTC MONOGRAPH FINAL part348 Ansell Healthcare Inc LIDOCAINE 10 mg/.1mL 10189-001_ec867813-f568-4d49-8e89-94ee2f4d0580 10189-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19730601 UNAPPROVED MEDICAL GAS Butler Gas Products Company OXYGEN 990 mL/L 10191-1013_cab6232e-4cd9-4c73-989e-13a5246869c5 10191-1013 HUMAN PRESCRIPTION DRUG MORPHINUM MORPHINE BASE PELLET SUBLINGUAL 20010427 UNAPPROVED HOMEOPATHIC Remedy Makers MORPHINE 30 [hp_C]/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10191-1029_26d4e1a1-94cf-44b8-b83a-8be26c36376e 10191-1029 HUMAN PRESCRIPTION DRUG Morphinum Muriaticum Morphine Hydrochloride PELLET SUBLINGUAL 20020409 UNAPPROVED HOMEOPATHIC Remedy Makers MORPHINE HYDROCHLORIDE 30 [hp_C]/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10191-1045_5028f2db-f788-47d7-9afa-315c37a51cca 10191-1045 HUMAN PRESCRIPTION DRUG CODEINUM CODEINE BASE PELLET SUBLINGUAL 20080423 UNAPPROVED HOMEOPATHIC Remedy Makers CODEINE 100 [hp_C]/1 CII 10191-1093_c01f3bdf-9010-4318-9513-a9eeedbaf260 10191-1093 HUMAN PRESCRIPTION DRUG OPIUM RAW OPIUM GUM PELLET SUBLINGUAL 20011121 UNAPPROVED HOMEOPATHIC Remedy Makers OPIUM 30 [hp_C]/1 CII 10191-1177_67f493a4-72e1-4c84-8230-ac298d890d12 10191-1177 HUMAN PRESCRIPTION DRUG CHLORALUM CHLORAL HYDRATE PELLET SUBLINGUAL 20000204 UNAPPROVED HOMEOPATHIC Remedy Makers CHLORAL HYDRATE 3 [hp_X]/1 CIV 10191-1201_61541ca1-bc53-49d7-9dc8-2e59830df11c 10191-1201 HUMAN OTC DRUG ALLIUM CEPA ONION PELLET SUBLINGUAL 20091216 UNAPPROVED HOMEOPATHIC Remedy Makers ONION 6 [hp_C]/1 10191-1203_82a05dc1-943a-45ea-b6ac-0f32e4693aa9 10191-1203 HUMAN OTC DRUG ALLIUM CEPA ONION PELLET SUBLINGUAL 20030512 UNAPPROVED HOMEOPATHIC Remedy Makers ONION 12 [hp_C]/1 10191-1204_aff8b8b6-ae65-408b-a3ef-a1e5c9e1760d 10191-1204 HUMAN OTC DRUG ALLIUM CEPA ONION PELLET SUBLINGUAL 20040929 UNAPPROVED HOMEOPATHIC Remedy Makers ONION 15 [hp_C]/1 10191-1205_b204f304-8b48-48fb-9484-4bd41c34fbf9 10191-1205 HUMAN OTC DRUG ALLIUM CEPA ONION PELLET SUBLINGUAL 20040811 UNAPPROVED HOMEOPATHIC Remedy Makers ONION 30 [hp_C]/1 10191-1225_1cd90a1d-3598-4430-b7b6-e5406454b2c9 10191-1225 HUMAN PRESCRIPTION DRUG APOMORPHINUM MURIATICUM APOMORPHINE HYDROCHLORIDE PELLET SUBLINGUAL 20020318 UNAPPROVED HOMEOPATHIC Remedy Makers APOMORPHINE HYDROCHLORIDE 3 [hp_X]/1 Dopamine Agonists [MoA],Dopaminergic Agonist [EPC] 10191-1242_e0bfd9dc-cb3f-46cf-8ea0-b7293e7fab99 10191-1242 HUMAN OTC DRUG ARNICA MONTANA WHOLE ARNICA PLANT PELLET SUBLINGUAL 20030806 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 6 [hp_X]/1 10191-1243_29feaf50-1b47-4b80-97a5-2cd63f2bf129 10191-1243 HUMAN OTC DRUG ARNICA MONTANA WHOLE ARNICA PLANT PELLET SUBLINGUAL 20080424 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 9 [hp_X]/1 10191-1244_c811fcf9-f8bf-4a2c-bf8a-f43112ebf73c 10191-1244 HUMAN OTC DRUG ARNICA MONTANA WHOLE ARNICA PLANT PELLET SUBLINGUAL 20050328 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 12 [hp_X]/1 10191-1245_3165f866-4839-4d3a-8fb8-ea78d31f7cda 10191-1245 HUMAN OTC DRUG ARNICA MONTANA WHOLE ARNICA PLANT PELLET SUBLINGUAL 20080424 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 15 [hp_X]/1 10191-1246_e424ca5f-bb7e-4a54-8202-7161025b0323 10191-1246 HUMAN OTC DRUG ARNICA MONTANA WHOLE ARNICA PLANT PELLET SUBLINGUAL 20020821 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 30 [hp_X]/1 10191-1248_a4ba17ab-c3b2-473d-8cc0-e78b94858f0b 10191-1248 HUMAN OTC DRUG ARNICA MONTANA ARNICA WHOLE PLANT PELLET SUBLINGUAL 20080424 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 3 [hp_C]/1 10191-1249_78abcbc1-e124-46c1-9402-4c16650a05ef 10191-1249 HUMAN OTC DRUG ARNICA MONTANA WHOLE PLANT (WHOLE PLANT) PELLET SUBLINGUAL 20050824 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 6 [hp_C]/1 10191-1250_0fbe445b-ec09-4695-80de-c6cefbd82e2a 10191-1250 HUMAN OTC DRUG ARNICA MONTANA (WHOLE PLANT) WHOLE ARNICA PLANT PELLET SUBLINGUAL 20050824 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 9 [hp_C]/1 10191-1251_ef8744d8-8e76-4916-aea1-064f51cdc2af 10191-1251 HUMAN OTC DRUG ARNICA MONTANA (WHOLE PLANT) ARNICA WHOLE PLANT PELLET SUBLINGUAL 20030108 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 12 [hp_C]/1 10191-1252_2c4f2489-0baa-408c-a17e-6081755ef4e0 10191-1252 HUMAN OTC DRUG ARNICA MONTANA WHOLE ARNICA PLANT PELLET SUBLINGUAL 20030109 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 150 [hp_C]/1 10191-1253_5e48e261-ef6d-4019-9590-a36fbab3ae03 10191-1253 HUMAN OTC DRUG ARNICA MONTANA WHOLE PLANT WHOLE ARNICA PLANT PELLET SUBLINGUAL 20040706 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 30 [hp_C]/1 10191-1254_1b98a3c1-32ed-4e81-82e3-5ab30736ddc5 10191-1254 HUMAN OTC DRUG ARNICA MONTANA (WHOLE PLANT) ARNICA WHOLE PLANT PELLET SUBLINGUAL 20030109 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 100 [hp_C]/1 10191-1255_5ffbdaa5-43e0-4740-88a7-43a589dcaa8b 10191-1255 HUMAN OTC DRUG ARNICA MONTANA (Whole Plant) ARNICA WHOLE PLANT PELLET SUBLINGUAL 20020821 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 20 [hp_M]/1 10191-1361_1243c2c1-6a92-4123-8f19-b2af111e71b8 10191-1361 HUMAN OTC DRUG CHAMOMILLA CHAMOMILE PLANT PELLET SUBLINGUAL 20041015 UNAPPROVED HOMEOPATHIC Remedy Makers MATRICARIA RECUTITA 6 [hp_C]/1 10191-1365_15f1cebd-5148-4255-ad63-eaed30cb509c 10191-1365 HUMAN OTC DRUG CHAMOMILLA CHAMOMILLA PLANT PELLET SUBLINGUAL 20050913 UNAPPROVED HOMEOPATHIC Remedy Makers MATRICARIA RECUTITA 30 [hp_C]/1 10191-1411_e7238368-0c10-421a-a99c-84e3851d92cd 10191-1411 HUMAN OTC DRUG CUPRUM METALLICUM COPPER PELLET SUBLINGUAL 20030618 UNAPPROVED HOMEOPATHIC REMEDY MAKERS COPPER 12 [hp_C]/1 10191-1413_9e72b0d3-48b8-4c17-9cdc-1fbfc9a77a4e 10191-1413 HUMAN OTC DRUG CUPRUM METALLICUM COPPER PELLET SUBLINGUAL 20030625 UNAPPROVED HOMEOPATHIC Remedy Makers COPPER 30 [hp_C]/1 10191-1425_747a7374-e139-4c85-8c91-8e023ae0f81d 10191-1425 HUMAN OTC DRUG HYPERICUM PERFORATUM ST JOHNS WORT PELLET SUBLINGUAL 20041015 UNAPPROVED HOMEOPATHIC Remedy Makers HYPERICUM PERFORATUM 6 [hp_C]/1 10191-1429_eafaef57-3e92-4b2f-86d5-55a1408e6684 10191-1429 HUMAN OTC DRUG HYPERICUM PERFORATUM ST JOHNS WORT PELLET SUBLINGUAL 20080416 UNAPPROVED HOMEOPATHIC Remedy Makers HYPERICUM PERFORATUM 30 [hp_C]/1 10191-1445_3be8d685-3dba-4fd8-a68f-61fae50ef834 10191-1445 HUMAN OTC DRUG KALI BICHROMICUM POTASSIUM DICHROMATE PELLET SUBLINGUAL 20030521 UNAPPROVED HOMEOPATHIC Remedy Makers POTASSIUM DICHROMATE 30 [hp_C]/1 10191-1457_841e844b-e071-4fc9-92a6-794a78dff30d 10191-1457 HUMAN OTC DRUG LACHESIS MUTUS BUSHMASTER VENOM PELLET SUBLINGUAL 20061031 UNAPPROVED HOMEOPATHIC REMEDY MAKERS LACHESIS MUTA VENOM 6 [hp_C]/1 10191-1458_c756a2e9-f37f-4c4e-994e-e868e0b2e44a 10191-1458 HUMAN OTC DRUG LACHESIS MUTUS BUSHMASTER VENOM PELLET SUBLINGUAL 20030502 UNAPPROVED HOMEOPATHIC REMEDY MAKERS LACHESIS MUTA VENOM 9 [hp_C]/1 10191-1459_b37faf2d-22b7-4196-a794-0c33cf226a6e 10191-1459 HUMAN OTC DRUG LACHESIS MUTUS BUSHMASTER VENOM PELLET SUBLINGUAL 20030505 UNAPPROVED HOMEOPATHIC REMEDY MAKERS LACHESIS MUTA VENOM 12 [hp_C]/1 10191-1460_bf95049e-7013-4b80-9856-fec85f7e7d9b 10191-1460 HUMAN OTC DRUG LACHESIS MUTUS BUSHMASTER VENOM PELLET SUBLINGUAL 20030507 UNAPPROVED HOMEOPATHIC REMEDY MAKERS LACHESIS MUTA VENOM 15 [hp_C]/1 10191-1461_5c14f901-fe85-4f0d-8fab-2d3e1a6f3b12 10191-1461 HUMAN OTC DRUG LACHESIS MUTUS BUSHMASTER SNAKE VENOM PELLET SUBLINGUAL 19990203 UNAPPROVED HOMEOPATHIC Remedy Makers LACHESIS MUTA VENOM 30 [hp_C]/1 10191-1562_b7b8928d-dc4d-4b20-92fb-a685855114be 10191-1562 HUMAN OTC DRUG SEPIA OFFICINALIS CUTTLEFISH PELLET SUBLINGUAL 20000221 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SEPIA OFFICINALIS JUICE 6 [hp_X]/1 10191-1566_3c2e96aa-70fb-4a33-8509-34c03ac22548 10191-1566 HUMAN OTC DRUG SEPIA OFFICINALIS CUTTLEFISH PELLET SUBLINGUAL 20000221 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SEPIA OFFICINALIS JUICE 30 [hp_X]/1 10191-1569_b04dce81-b665-4370-a101-b36fa43850c4 10191-1569 HUMAN OTC DRUG SEPIA OFFICINALIS CUTTLEFISH PELLET SUBLINGUAL 20030507 UNAPPROVED HOMEOPATHIC Remedy Makers CUTTLEFISH 6 [hp_C]/1 10191-1570_ff12e18c-235a-42fd-8241-e886d0c3e1c4 10191-1570 HUMAN OTC DRUG SEPIA OFFICINALIS CUTTLEFISH PELLET SUBLINGUAL 20040428 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SEPIA OFFICINALIS JUICE 9 [hp_C]/1 10191-1571_47facc8a-4782-402d-ae23-4fa442287240 10191-1571 HUMAN OTC DRUG SEPIA OFFICINALIS CUTTLEFISH PELLET SUBLINGUAL 20030423 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SEPIA OFFICINALIS JUICE 12 [hp_C]/1 10191-1573_5be95f06-5af7-4678-8814-ea88925858ec 10191-1573 HUMAN OTC DRUG SEPIA OFFICINALIS CUTTLEFISH PELLET SUBLINGUAL 20020821 UNAPPROVED HOMEOPATHIC Remedy Makers CUTTLEFISH 30 [hp_C]/1 10191-1578_b47d449e-7bb3-4708-8ece-fd498725f9a7 10191-1578 HUMAN OTC DRUG SULPHUR SULFUR PELLET SUBLINGUAL 19981208 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SULFUR 6 [hp_X]/1 10191-1585_21ccc2d5-c363-443e-9b43-2c5e1ae04e28 10191-1585 HUMAN OTC DRUG SULPHUR SULFUR PELLET SUBLINGUAL 19981215 UNAPPROVED HOMEOPATHIC Remedy Makers SULFUR 6 [hp_C]/1 10191-1587_0d2d80ef-904d-4cf4-8e71-46c0ea48e117 10191-1587 HUMAN OTC DRUG SULPHUR SULFUR PELLET SUBLINGUAL 20030430 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SULFUR 12 [hp_C]/1 10191-1589_63494dd2-60c5-422a-bc8d-dbf498cd16fa 10191-1589 HUMAN OTC DRUG SULPHUR SULFUR PELLET SUBLINGUAL 20020909 UNAPPROVED HOMEOPATHIC Remedy Makers SULFUR 30 [hp_C]/1 10191-1602_08966ee7-b423-4606-826b-0b4858a5f73b 10191-1602 HUMAN OTC DRUG SYMPHYTUM OFFICINALE COMFREY PLANT PELLET SUBLINGUAL 20040204 UNAPPROVED HOMEOPATHIC REMEDY MAKERS COMFREY LEAF 9 [hp_C]/1 10191-1603_07c407e9-1537-402a-8360-95d7c4ec7502 10191-1603 HUMAN OTC DRUG SYMPHYTUM OFFICINALE COMFREY PLANT PELLET SUBLINGUAL 20040204 UNAPPROVED HOMEOPATHIC REMEDY MAKERS COMFREY LEAF 12 [hp_C]/1 10191-1637_48fdb5e3-a586-48c2-b086-6f5c75ba2dd4 10191-1637 HUMAN OTC DRUG MERCURIUS SOLUBILIS SOLUBLE MERCURY PELLET SUBLINGUAL 20011116 UNAPPROVED HOMEOPATHIC Remedy Makers MERCURIUS SOLUBILIS 30 [hp_C]/1 10191-1653_57938a50-32d7-45e6-814b-3afa5e4ce636 10191-1653 HUMAN OTC DRUG CALCAREA CARBONICA CALCIUM CARBONATE PELLET SUBLINGUAL 20040824 UNAPPROVED HOMEOPATHIC Remedy Makers CALCIUM CARBONATE 30 [hp_C]/1 10191-1665_beff73bc-c5b8-4b95-8c8e-2c61a2067cb6 10191-1665 HUMAN OTC DRUG KALI CARBONICUM POTASSIUM CARBONATE PELLET SUBLINGUAL 20111208 UNAPPROVED HOMEOPATHIC REMEDY MAKERS POTASSIUM CARBONATE 6 [hp_C]/1 10191-1714_171c3166-36b7-406d-9de6-bb94d8e89423 10191-1714 HUMAN OTC DRUG HEPAR SULPHURIS CALCAREUM CRUDE CALCIUM SULFIDE PELLET SUBLINGUAL 20030514 UNAPPROVED HOMEOPATHIC REMEDY MAKERS CALCIUM SULFIDE 9 [hp_C]/1 10191-1717_caba5ea3-2a91-4d46-8b40-ae04fd2fa16d 10191-1717 HUMAN OTC DRUG HEPAR SULPHURIS CALCAREUM CRUDE CALCIUM SULFIDE PELLET SUBLINGUAL 20040708 UNAPPROVED HOMEOPATHIC REMEDY MAKERS CALCIUM SULFIDE 30 [hp_C]/1 10191-1761_bcb3aa74-3fad-403c-9caf-7b796a37eaa6 10191-1761 HUMAN OTC DRUG CARBO VEGETABILIS ACTIVATED CHARCOAL PELLET SUBLINGUAL 20100224 UNAPPROVED HOMEOPATHIC Remedy Makers ACTIVATED CHARCOAL 6 [hp_C]/1 10191-1763_ad4f6532-0c31-4fe2-84c2-773a8b1f0657 10191-1763 HUMAN OTC DRUG CARBO VEGETABILIS ACTIVATED CHARCOAL PELLET SUBLINGUAL 20041014 UNAPPROVED HOMEOPATHIC REMEDY MAKERS ACTIVATED CHARCOAL 12 [hp_C]/1 10191-1765_40d22783-eabc-4b99-be58-dad2327bf632 10191-1765 HUMAN OTC DRUG CARBO VEGETABILIS ACTIVATED CHARCOAL PELLET SUBLINGUAL 20020821 UNAPPROVED HOMEOPATHIC Remedy Makers ACTIVATED CHARCOAL 30 [hp_C]/1 10191-1794_d32457a2-8cff-4c4b-9677-cdd4349cf15a 10191-1794 HUMAN OTC DRUG GRAPHITE GRAPHITES PELLET SUBLINGUAL 20040826 UNAPPROVED HOMEOPATHIC REMEDY MAKERS GRAPHITE 9 [hp_C]/1 10191-1795_47579a47-b9fe-40ff-b366-f24ac5fe5d29 10191-1795 HUMAN OTC DRUG GRAPHITES GRAPHITE PELLET SUBLINGUAL 20030514 UNAPPROVED HOMEOPATHIC REMEDY MAKERS GRAPHITE 12 [hp_C]/1 10191-1797_5cca3e35-d449-4dbd-b47f-f6be94098451 10191-1797 HUMAN OTC DRUG GRAPHITES GRAPHITE PELLET SUBLINGUAL 20041014 UNAPPROVED HOMEOPATHIC Remedy Makers GRAPHITE 30 [hp_C]/1 10191-1822_62bd5094-6e66-4e44-bd46-8692cee24304 10191-1822 HUMAN OTC DRUG SILICEA SILICON DIOXIDE PELLET SUBLINGUAL 20040811 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SILICON DIOXIDE 30 [hp_X]/1 10191-1825_6c9df045-2bfb-4347-835e-ad2563e2441a 10191-1825 HUMAN OTC DRUG SILICEA SILICON DIOXIDE PELLET SUBLINGUAL 20040811 UNAPPROVED HOMEOPATHIC Remedy Makers SILICON DIOXIDE 6 [hp_C]/1 10191-1826_90e5ec15-5ed3-4090-8806-b303e751b2c4 10191-1826 HUMAN OTC DRUG SILICEA SILICON DIOXIDE PELLET SUBLINGUAL 20020821 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SILICON DIOXIDE 9 [hp_C]/1 10191-1828_e664b84f-706a-4ff1-a69b-24dcc32e71c2 10191-1828 HUMAN OTC DRUG SILICEA SILICON DIOXIDE PELLET SUBLINGUAL 20030430 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SILICON DIOXIDE 15 [hp_C]/1 10191-1829_c426c8db-eb06-4203-87fa-06ea7c0f0fcf 10191-1829 HUMAN OTC DRUG SILICEA SILICA PELLET SUBLINGUAL 20020821 UNAPPROVED HOMEOPATHIC Remedy Makers SILICON DIOXIDE 30 [hp_C]/1 10191-1841_e952cbaa-1420-49af-8d3c-a05c704c46a9 10191-1841 HUMAN OTC DRUG ANTIMONIUM TARTARICUM ANTIMONY POTASSIUM TARTRATE PELLET SUBLINGUAL 20100106 UNAPPROVED HOMEOPATHIC Remedy Makers ANTIMONY POTASSIUM TARTRATE 6 [hp_C]/1 10191-1842_1c8ee4c3-f0df-4bfe-aa6a-6e6857dfcb44 10191-1842 HUMAN OTC DRUG ANTIMONIUM TARTARICUM Antimony Potassium Tartrate PELLET SUBLINGUAL 20020909 UNAPPROVED HOMEOPATHIC Remedy Makers ANTIMONY POTASSIUM TARTRATE 9 [hp_C]/1 10191-1843_883f3dcd-2714-4d76-82af-24bc6e7e98b3 10191-1843 HUMAN OTC DRUG ANTIMONIUM TARTARICUM ANTIMONY POTASSIUM TARTRATE PELLET SUBLINGUAL 20040929 UNAPPROVED HOMEOPATHIC Remedy Makers ANTIMONY POTASSIUM TARTRATE 12 [hp_C]/1 10191-1844_303af7ac-5b7c-48de-b9a2-a3040f50c965 10191-1844 HUMAN OTC DRUG ANTIMONIUM TARTARICUM ANTIMONY POTASSIUM TARTRATE PELLET SUBLINGUAL 20041011 UNAPPROVED HOMEOPATHIC Remedy Makers ANTIMONY POTASSIUM TARTRATE 15 [hp_C]/1 10191-1845_dd13a759-7821-43e7-b8a5-81ddb86ed320 10191-1845 HUMAN OTC DRUG ANTIMONIUM TARTARICUM ANTIMONY POTASSIUM TARTRATE PELLET SUBLINGUAL 20030423 UNAPPROVED HOMEOPATHIC Remedy Makers ANTIMONY POTASSIUM TARTRATE 30 [hp_C]/1 10191-1857_db300b0e-6a18-4f56-9282-ac61c4e1232a 10191-1857 HUMAN OTC DRUG KALI IODATUM POTASSIUM IODIDE PELLET SUBLINGUAL 20040812 UNAPPROVED HOMEOPATHIC REMEDY MAKERS POTASSIUM IODIDE 6 [hp_C]/1 10191-1873_e0a1b426-94b1-4305-a571-cd778fa310df 10191-1873 HUMAN OTC DRUG CALCAREA FLUORICA CALCIUM FLUORIDE PELLET SUBLINGUAL 20040813 UNAPPROVED HOMEOPATHIC Remedy Makers CALCIUM FLUORIDE 6 [hp_C]/1 10191-1877_23143135-96a1-4c5c-9edf-d930ea4ce278 10191-1877 HUMAN OTC DRUG CALCAREA FLUORICA CALCIUM FLUORIDE PELLET SUBLINGUAL 20080409 UNAPPROVED HOMEOPATHIC Remedy Makers CALCIUM FLUORIDE 30 [hp_C]/1 10191-1889_32006b06-1cb2-4973-b4e8-3487a5537d88 10191-1889 HUMAN OTC DRUG CALCAREA SULPHURICA CALCIUM SULFATE PELLET SUBLINGUAL 20030423 UNAPPROVED HOMEOPATHIC Remedy Makers CALCIUM SULFATE 6 [hp_C]/1 10191-1893_1a46da00-a627-4998-8a2b-1d93958e173c 10191-1893 HUMAN OTC DRUG CALCAREA SULPHURICA CALCIUM SULFATE PELLET SUBLINGUAL 20050728 UNAPPROVED HOMEOPATHIC Remedy Makers CALCIUM SULFATE 30 [hp_C]/1 10191-1905_8ac22923-6867-4a22-8ea7-0bfd666336ed 10191-1905 HUMAN OTC DRUG FERRUM PHOSPHORICUM FERROSOFERRIC PHOSPHATE PELLET SUBLINGUAL 20041014 UNAPPROVED HOMEOPATHIC Remedy Makers FERRUM PHOSPHORICUM 6 [hp_C]/1 10191-1909_38e4050d-3ff6-4653-8508-c66f7fb8693a 10191-1909 HUMAN OTC DRUG FERRUM PHOSPHORICUM FERROSOFERRIC PHOSPHATE PELLET SUBLINGUAL 20040713 UNAPPROVED HOMEOPATHIC Remedy Makers FERRUM PHOSPHORICUM 30 [hp_C]/1 10191-1929_891b6875-6592-4f63-a0b8-f19dbca17ed8 10191-1929 HUMAN OTC DRUG APIS MELLIFICA BEE VENOM PELLET SUBLINGUAL 20040928 UNAPPROVED HOMEOPATHIC Remedy Makers APIS MELLIFERA 3 [hp_X]/1 10191-1930_5d0b80b2-46b3-4362-96d3-7693881adf66 10191-1930 HUMAN OTC DRUG APIS MELLIFICA BEE VENOM PELLET SUBLINGUAL 20040928 UNAPPROVED HOMEOPATHIC Remedy Makers APIS MELLIFERA 6 [hp_X]/1 10191-1932_a1e43089-21cc-4827-91dc-9d0b1ad2dd20 10191-1932 HUMAN OTC DRUG APIS MELLIFICA BEE VENOM PELLET SUBLINGUAL 20030109 UNAPPROVED HOMEOPATHIC Remedy Makers APIS MELLIFERA 12 [hp_X]/1 10191-1934_3719d3a0-da81-4f0a-ab21-2a43156e6846 10191-1934 HUMAN OTC DRUG APIS MELLIFICA BEE VENOM PELLET SUBLINGUAL 20040928 UNAPPROVED HOMEOPATHIC Remedy Makers APIS MELLIFERA 30 [hp_X]/1 10191-1937_15bebddc-958c-4ef3-82a5-fd76d7452304 10191-1937 HUMAN OTC DRUG APIS MELLIFICA BEE VENOM PELLET SUBLINGUAL 20040928 UNAPPROVED HOMEOPATHIC Remedy Makers APIS MELLIFERA 6 [hp_C]/1 10191-1938_5881ffa6-8e1e-45d5-91c6-d8fd178801d9 10191-1938 HUMAN OTC DRUG APIS MELLIFICA BEE VENOM PELLET SUBLINGUAL 20040928 UNAPPROVED HOMEOPATHIC Remedy Makers APIS MELLIFERA 9 [hp_C]/1 10191-1940_c0287ee7-37ed-453f-acb5-ffd596f4c0f7 10191-1940 HUMAN OTC DRUG APIS MELLIFICA BEE VENOM PELLET SUBLINGUAL 20040928 UNAPPROVED HOMEOPATHIC Remedy Makers APIS MELLIFERA 15 [hp_C]/1 10191-1941_911e6b31-d62e-4641-b5be-ecf40cc2cf5e 10191-1941 HUMAN OTC DRUG APIS MELLIFICA BEE VENOM PELLET SUBLINGUAL 20050329 UNAPPROVED HOMEOPATHIC Remedy Makers APIS MELLIFERA 30 [hp_C]/1 10191-1973_5ea2ca3b-e142-4f90-be80-00ce41f2f894 10191-1973 HUMAN OTC DRUG MAGNESIA MURIATICA MAGNESIUM CHLORIDE PELLET SUBLINGUAL 20060428 UNAPPROVED HOMEOPATHIC REMEDY MAKERS MAGNESIUM CHLORIDE 30 [hp_C]/1 10191-1989_8027c863-e82c-44a6-8117-72b2c9081277 10191-1989 HUMAN OTC DRUG ARSENICUM ALBUM ARSENIC TRIOXIDE PELLET SUBLINGUAL 20040712 UNAPPROVED HOMEOPATHIC Remedy Makers ARSENIC TRIOXIDE 30 [hp_C]/1 10191-2034_a47a3b8c-fe3d-47d6-9601-9d57b9b8cf6f 10191-2034 HUMAN OTC DRUG LYCOPODIUM CLAVATUM CLUBMOSS PELLET SUBLINGUAL 20030507 UNAPPROVED HOMEOPATHIC REMEDY MAKERS LYCOPODIUM CLAVATUM SPORE 9 [hp_C]/1 10202-050_fe6fb0f0-8306-43dd-812a-c2cf5a8fe7e3 10202-050 HUMAN OTC DRUG 7 Select Ibuprofen PM diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20140805 ANDA ANDA079113 7-Eleven DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 10202-056_b8a9ec6b-380b-4377-b154-7a99922430ba 10202-056 HUMAN OTC DRUG 7 select night time relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140417 OTC MONOGRAPH FINAL part341 7-Eleven ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 10202-085_f3b7863e-bd27-4e16-a16c-04e44bd16055 10202-085 HUMAN OTC DRUG 7-11 Instant Hand Sanitizer With Aloe And Vitamin E ALCOHOL LIQUID TOPICAL 20111102 OTC MONOGRAPH NOT FINAL part333E 7-11 ALCOHOL 62 mL/100mL 10202-130_e1f66785-1bdf-49ac-a0dd-5bc96810f92d 10202-130 HUMAN OTC DRUG 7 Select Childrens Pain Relief Acetaminophen SUSPENSION ORAL 20140813 OTC MONOGRAPH NOT FINAL part343 7-Eleven ACETAMINOPHEN 160 mg/5mL 10202-186_a291b77b-2785-47b1-aaa0-dc8177b9e27b 10202-186 HUMAN OTC DRUG 7 Select Night Time Sleep Aid Diphenhydramine HCl LIQUID ORAL 20140422 OTC MONOGRAPH FINAL part338 7-Eleven DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 10202-194_adedd68d-5122-40c7-9998-534021e498ad 10202-194 HUMAN OTC DRUG 7 Select Acid Controller Famotidine TABLET ORAL 20140805 ANDA ANDA077351 7-Eleven FAMOTIDINE 20 mg/1 10202-224_706da376-60af-457e-bb87-d238a20ed358 10202-224 HUMAN OTC DRUG 7 Select Anti Diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20140805 ANDA ANDA075232 7-Eleven LOPERAMIDE HYDROCHLORIDE 2 mg/1 10202-259_9b694189-6e16-4814-a797-ce3fb4d41dcd 10202-259 HUMAN OTC DRUG 7 Select Adult Chewable Aspirin Aspirin TABLET, CHEWABLE ORAL 20140805 OTC MONOGRAPH NOT FINAL part343 7-Eleven ASPIRIN 81 mg/1 10202-304_2922d79a-5a3a-4bb0-be0f-9c7cc8a68cf8 10202-304 HUMAN OTC DRUG 7 Select Nasal oxymetazoline hydrochloride SPRAY NASAL 20140805 OTC MONOGRAPH FINAL part341 7-Eleven OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 10202-335_e0ef4b9b-6ae4-42c8-ad56-6ed64114e9f9 10202-335 HUMAN OTC DRUG 7 select night time relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20140805 OTC MONOGRAPH FINAL part341 7-Eleven ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 10202-337_8eadf0f3-cdfe-4203-a303-5be99e2f02af 10202-337 HUMAN OTC DRUG 7 Select Pink Bismuth Bismuth subsalicylate SUSPENSION ORAL 20140417 OTC MONOGRAPH FINAL part335 7-Eleven BISMUTH SUBSALICYLATE 1050 mg/30mL 10202-368_b5f35332-2548-44a4-8d5c-9bbb1b3218ca 10202-368 HUMAN OTC DRUG 7 select naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20140805 ANDA ANDA074661 7-Eleven NAPROXEN SODIUM 220 mg/1 10202-374_56008815-37e9-4493-a88b-3cc30b72725e 10202-374 HUMAN OTC DRUG 7 Select Migraine Formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20140509 ANDA ANDA075794 7-Eleven ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 10202-379_2388e766-cf6d-4b9e-ac03-65a4d1927720 10202-379 HUMAN OTC DRUG 7 select allergy childrens Diphenhydramine HCl LIQUID ORAL 20140805 OTC MONOGRAPH FINAL part341 7-Eleven DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 10202-384_76fd12e8-6d16-4760-8bde-5e1af8b01ac0 10202-384 HUMAN OTC DRUG 7 Select Cough DM dextromethorphan polistirex SUSPENSION ORAL 20140905 ANDA ANDA091135 7-Eleven DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 10202-416_3c60c115-37d2-44cf-bcb5-7691f8af8867 10202-416 HUMAN OTC DRUG 7 Select Aspirin Aspirin TABLET ORAL 20140805 OTC MONOGRAPH NOT FINAL part343 7-Eleven ASPIRIN 325 mg/1 10202-441_f01921ff-ed85-4f09-88bf-9abaf26e1c1c 10202-441 HUMAN OTC DRUG 7 Select Sleep Aid Doxylamine succinate TABLET ORAL 20140805 ANDA ANDA040167 7-Eleven DOXYLAMINE SUCCINATE 25 mg/1 10202-458_9831decc-17b5-4a3e-82b6-afbe3fc7edbb 10202-458 HUMAN OTC DRUG 7 select all day allergy Cetirizine Hydrochloride TABLET ORAL 20140429 ANDA ANDA078336 7-Eleven CETIRIZINE HYDROCHLORIDE 10 mg/1 10202-479_21f328fa-648d-4166-9d86-2a41dd14387b 10202-479 HUMAN OTC DRUG 7 Select Allergy Diphenhydramine Hydrochloride TABLET ORAL 20140422 OTC MONOGRAPH FINAL part341 7-Eleven DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 10202-484_168da31e-de62-4280-9c66-2b41d2d93c31 10202-484 HUMAN OTC DRUG 7 select acetaminophen Acetaminophen TABLET ORAL 20140514 OTC MONOGRAPH NOT FINAL part343 7-Eleven ACETAMINOPHEN 500 mg/1 10202-489_3b303df6-0aaa-4941-84ca-c11077e2a7c6 10202-489 HUMAN OTC DRUG 7 Select Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20140911 OTC MONOGRAPH FINAL part331 7-Eleven CALCIUM CARBONATE 750 mg/1 10202-490_c76c983e-d680-4908-b79d-968a2e4b1246 10202-490 HUMAN OTC DRUG 7 Select Naproxen Sodium Naproxen Sodium TABLET ORAL 20140811 ANDA ANDA074661 7-Eleven NAPROXEN SODIUM 220 mg/1 10202-498_46949861-f48b-47ae-acad-9ac8c97ea77d 10202-498 HUMAN OTC DRUG 7 select mucus relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20141026 ANDA ANDA078912 7-Eleven GUAIFENESIN 600 mg/1 10202-571_f2a69f9c-6467-4fa8-a969-736a39beb142 10202-571 HUMAN OTC DRUG 7 Select Allergy Relief fexofenadine hcl TABLET, FILM COATED ORAL 20140417 ANDA ANDA076447 7-Eleven FEXOFENADINE HYDROCHLORIDE 180 mg/1 10202-604_52caed9e-acce-4e25-af7a-fd61264fede0 10202-604 HUMAN OTC DRUG 7 select ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20140807 ANDA ANDA072096 7-Eleven IBUPROFEN 200 mg/1 10202-612_fc61e1fb-a958-49ca-81d4-7e01c025dcdb 10202-612 HUMAN OTC DRUG 7 Select Allergy Relief Loratadine TABLET ORAL 20140514 ANDA ANDA076301 7-Eleven LORATADINE 10 mg/1 10202-647_66e2a92c-2827-413f-9349-898cc7dc009a 10202-647 HUMAN OTC DRUG 7 Select Ibuprofen Ibuprofen TABLET, COATED ORAL 20140513 ANDA ANDA072096 7-Eleven IBUPROFEN 200 mg/1 10202-656_abcd8682-a8ce-424c-9b72-65f5ada5c48a 10202-656 HUMAN OTC DRUG 7 select day time relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20140805 OTC MONOGRAPH FINAL part341 7-Eleven ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 10202-751_788f1a4e-8314-4a2b-be48-7f15c162f102 10202-751 HUMAN OTC DRUG 7 Select Pain Relief PM Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20140904 OTC MONOGRAPH NOT FINAL part343 7-Eleven ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 10202-852_5418b610-7a97-46a3-80b1-95cc04408cb7 10202-852 HUMAN OTC DRUG 7 Select Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20140422 ANDA ANDA091429 7-Eleven RANITIDINE HYDROCHLORIDE 150 mg/1 10202-897_0225c68b-7936-4e04-9265-c8a0e8e6a08d 10202-897 HUMAN OTC DRUG 7 Select Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20140805 ANDA ANDA074937 7-Eleven IBUPROFEN 100 mg/5mL 10202-906_de03ff7b-8030-4448-bcd5-b0c8d2a744e8 10202-906 HUMAN OTC DRUG 7 select cold and allergy childrens phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20140805 OTC MONOGRAPH FINAL part341 7-Eleven BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 10202-974_079d0796-8970-4046-8fa5-ebbaccbdb98f 10202-974 HUMAN OTC DRUG 7 Select Childrens Allergy Relief cetirizine hydrochloride SOLUTION ORAL 20140805 ANDA ANDA090254 7-Eleven CETIRIZINE HYDROCHLORIDE 5 mg/5mL 10202-994_e61aee43-63c4-43b4-9ac8-c99a50726103 10202-994 HUMAN OTC DRUG 7 select day time relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20140422 OTC MONOGRAPH FINAL part341 7-Eleven ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 10210-0001_753a3d05-9b2d-47e5-96e8-cbd50e001088 10210-0001 HUMAN OTC DRUG CARMEX cherry lip balm BROAD SPECTRUM SPF 15 SUNSCREEN AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE SALVE TOPICAL 20130926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 5; 3; 4 g/100g; g/100g; g/100g; g/100g 10210-0002_01c444c1-e986-4ab6-995a-0aff1502e3d7 10210-0002 HUMAN OTC DRUG CARMEX strawberry lip balm BROAD SPECTRUM SPF 15 SUNSCREEN AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE SALVE TOPICAL 20130926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 5; 3; 4 g/100g; g/100g; g/100g; g/100g 10210-0003_43352aac-9d2b-4fde-843e-8f24db119e87 10210-0003 HUMAN OTC DRUG CARMEX original lip balm BROAD SPECTRUM SPF 15 SUNSCREEN AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE SALVE TOPICAL 20130926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 5; 3; 4 g/100g; g/100g; g/100g; g/100g 10210-0004_3a931fb7-4df7-45d2-bab5-516ba9b7de5b 10210-0004 HUMAN OTC DRUG CARMEX Pomegranate BROAD SPECTRUM SPF 15 SUNSCREEN AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE SALVE TOPICAL 20130926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 5; 3; 4 g/100g; g/100g; g/100g; g/100g 10210-0005_6b7f4bb5-ede8-47cd-b03b-58d781366a56 10210-0005 HUMAN OTC DRUG CARMEX Lime twist BROAD SPECTRUM SPF 15 SUNSCREEN AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE SALVE TOPICAL 20130926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 5; 3; 4 g/100g; g/100g; g/100g; g/100g 10210-0006_178917c6-9ca9-4a18-a9e1-2f72e43465ea 10210-0006 HUMAN OTC DRUG CARMEX Vanilla BROAD SPECTRUM SPF 15 SUNSCREEN AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE SALVE TOPICAL 20130926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 5; 3; 4 g/100g; g/100g; g/100g; g/100g 10210-0007_2a78fea0-405b-4c54-af07-1d6b8728f511 10210-0007 HUMAN OTC DRUG CARMEX moisture Plus Ultra Hydrating Lip Balm Broad Spectrum SPF 15 Sunscreen AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE SALVE TOPICAL 20131002 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 5.5; 3.3; 4.4 g/100g; g/100g; g/100g; g/100g 10210-0008_c34b5de2-dc66-4bb8-aa0a-5468335068e9 10210-0008 HUMAN OTC DRUG CARMEX original lip balm EXTERNAL ANALGESIC CAMPHOR (NATURAL), MENTHOL SALVE TOPICAL 20131002 OTC MONOGRAPH NOT FINAL part348 Carma Laboratories, Inc. CAMPHOR (NATURAL); MENTHOL 1.7; .7 g/100g; g/100g 10210-0009_f3c65668-5d84-456d-af5f-7945c90c05fd 10210-0009 HUMAN OTC DRUG CARMEX cherry lip balm BROAD SPECTRUM SPF 15 SUNSCREEN AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE SALVE TOPICAL 20130926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 5; 3; 4 g/100g; g/100g; g/100g; g/100g 10210-0010_aa904180-e375-41f6-9a6b-ae4a3f5bbf2b 10210-0010 HUMAN OTC DRUG CARMEX strawberry lip balm BROAD SPECTRUM SPF 15 SUNSCREEN AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE SALVE TOPICAL 20130926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 5; 3; 4 g/100g; g/100g; g/100g; g/100g 10210-0011_b7f6fb80-3ead-46a1-97fe-0d63a224de6b 10210-0011 HUMAN OTC DRUG CARMEX original lip balm EXTERNAL ANALGESIC CAMPHOR (NATURAL), MENTHOL SALVE TOPICAL 20131002 OTC MONOGRAPH NOT FINAL part348 Carma Laboratories, Inc. CAMPHOR (NATURAL); MENTHOL 1.7; .7 g/100g; g/100g 10210-0012_77e300b9-1682-4fe6-8c29-0a6b3693b6f8 10210-0012 HUMAN OTC DRUG CARMEX COLD SORE treatment External Analgesic BENZOCAINE CREAM TOPICAL 20140528 OTC MONOGRAPH NOT FINAL part348 Carma Laboratories, Inc. BENZOCAINE 10 g/100g 10216-3071_983a1364-6118-4d7e-9b80-5011306c0b7d 10216-3071 HUMAN PRESCRIPTION DRUG Topex Cherry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DENTSPLY Caulk BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 10216-3081_983a1364-6118-4d7e-9b80-5011306c0b7d 10216-3081 HUMAN PRESCRIPTION DRUG Topex Mint Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DENTSPLY Caulk BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 10216-3091_983a1364-6118-4d7e-9b80-5011306c0b7d 10216-3091 HUMAN PRESCRIPTION DRUG Topex Pina Colada Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DENTSPLY Caulk BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 10216-3110_983a1364-6118-4d7e-9b80-5011306c0b7d 10216-3110 HUMAN PRESCRIPTION DRUG Topex BUBBLE GUM Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DENTSPLY Caulk BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 10221-001_8b4a6998-b28c-4980-9657-3959dedbf76c 10221-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19690101 UNAPPROVED MEDICAL GAS Central McGowan Inc OXYGEN 992 mL/L 10221-002_38075eb0-1ccc-4618-a9e2-5732f1739621 10221-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20140201 NDA NDA205850 Central-McGowan, Inc. NITROGEN 99 L/100L 10223-0201_ffe18107-ade5-401c-bccd-722f8461f16a 10223-0201 HUMAN PRESCRIPTION DRUG Cetacaine Anesthetic Benzocaine, Butamben, and Tetracaine Hydrochloride AEROSOL, SPRAY TOPICAL 19580101 UNAPPROVED DRUG OTHER Cetylite Industries, Inc. BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE .028; .004; .004 g/.2g; g/.2g; g/.2g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 10223-0202_84e4e4f2-8fe4-4e3e-90c5-d1a9f8d2dad0 10223-0202 HUMAN PRESCRIPTION DRUG Cetacaine Anesthetic Benzocaine, Butamben, and Tetracaine Hydrochloride SOLUTION TOPICAL 19600101 UNAPPROVED DRUG OTHER Cetylite Industries, Inc. BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE .028; .004; .004 g/.2g; g/.2g; g/.2g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 10223-0217_77944cd3-87d8-4242-b845-82df8e05b20f 10223-0217 HUMAN PRESCRIPTION DRUG Cetacaine Topical Anesthetic Benzocaine, Butamben, and Tetracaine Hydrochloride GEL TOPICAL 19600101 UNAPPROVED DRUG OTHER Cetylite Industries, Inc. BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE .028; .004; .004 g/.2g; g/.2g; g/.2g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 10237-589_0e3bb3f3-d622-4b1a-920a-ada8a53e9886 10237-589 HUMAN OTC DRUG Arm and Hammer Baking Soda Sodium Bicarbonate POWDER, FOR SOLUTION ORAL 20000101 OTC MONOGRAPH FINAL part331 Church & Dwight Co., Inc. SODIUM BICARBONATE 1 g/g 10237-614_09340da6-1a71-41ee-b854-e4d871939909 10237-614 HUMAN OTC DRUG Mentadent Advanced Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20040401 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-616_c1490cc6-b712-4f7b-b1c7-ef5b74a2fef7 10237-616 HUMAN OTC DRUG Mentadent Advanced Breath Freshening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20040401 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-625_aa218d12-9987-4516-a9ac-57f328e636e1 10237-625 HUMAN OTC DRUG AIM Bubble Berry Sodium Fluoride GEL, DENTIFRICE DENTAL 20080101 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-626_d36d9769-317c-42e1-b7ab-789e2f44ece3 10237-626 HUMAN OTC DRUG AIM CAVITY PROTECTION Multi Benefit Sodium Fluoride GEL, DENTIFRICE DENTAL 20040301 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-628_c7d49659-efab-4313-963a-dd5ef70c6920 10237-628 HUMAN OTC DRUG AIM TARTAR CONTROL Plus Mouthwash and Whitening Sodium Fluoride GEL, DENTIFRICE DENTAL 20040301 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-629_44c80941-3a75-4676-a134-eab0752f450b 10237-629 HUMAN OTC DRUG AIM Whitening with Baking Soda Sodium Fluoride GEL, DENTIFRICE DENTAL 20040714 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-630_9b4596f6-0098-4683-94c6-614c872c069a 10237-630 HUMAN OTC DRUG AIM Cavity Protection with Whitening Sodium Fluoride GEL, DENTIFRICE DENTAL 20101110 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-631_2ef7e48b-dc5b-4285-ab76-6e4ae9921417 10237-631 HUMAN OTC DRUG AIM Cavity Protection Multi Benefit Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110804 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-644_056bb79a-fe0a-4076-aeb7-a39591c7036d 10237-644 HUMAN OTC DRUG CLOSE UP Freshening with Mouthwash Sodium Fluoride GEL, DENTIFRICE DENTAL 20010301 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-645_3c739677-f7a8-4ce8-8c3a-b8365a77dd8d 10237-645 HUMAN OTC DRUG CLOSE UP Whitening with Mouthwash Sodium Fluoride GEL, DENTIFRICE DENTAL 20101026 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-646_fa6d06a4-c39d-41c9-876d-b2c020413ba0 10237-646 HUMAN OTC DRUG CLOSE UP Freshening with Mouthwash Sodium Fluoride PASTE, DENTIFRICE DENTAL 20101026 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-650_1f808f59-48cb-4895-abf1-57bec3ddc0ac 10237-650 HUMAN OTC DRUG Pepsodent Complete Care Enamel-Safe WHITENING Sodium Fluoride PASTE, DENTIFRICE DENTAL 20040301 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-651_322d957f-fa9b-4450-9541-4a04134eea1c 10237-651 HUMAN OTC DRUG Pepsodent Complete Care Original Sodium Fluoride PASTE, DENTIFRICE DENTAL 20040301 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-652_5ef4a28a-5399-4fbc-a541-8c8ea1f52c59 10237-652 HUMAN OTC DRUG Dental Care Advance Cleaning Maximun Baking Soda Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-653_bb54412b-618b-4227-84fa-b8f7560c8a7f 10237-653 HUMAN OTC DRUG Complete Care Tartar Control Plus Whitening Baking Soda and Peroxide Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-654_a3723f80-2466-4fe3-a0c1-860a5d3743f5 10237-654 HUMAN OTC DRUG Complete Care Plus Enamel Strengthening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-655_9473282b-a873-46fa-8c6a-0575338e89e8 10237-655 HUMAN OTC DRUG Peroxie Care Tartar Control Healthy Gums Baking Soda and Peroxide Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-656_d3e8e7ba-5bee-4cda-b2f0-70dd9ad2c8ac 10237-656 HUMAN OTC DRUG Advance White Tartar Control Breath Freshening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-657_f11c7825-4f1c-437d-a2ed-9e06edb09f0e 10237-657 HUMAN OTC DRUG Advance White Breath Freshening Tartar Control Sodium Fluoride GEL, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-658_520c8392-00f6-4fda-b3b4-879f803d6744 10237-658 HUMAN OTC DRUG Advance White Extreme Whitening Tartar Control Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-659_47e415a8-8b9a-4be4-ae9d-59170afd4b1e 10237-659 HUMAN OTC DRUG Sensitive MultiProtection with Tartar Control Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. POTASSIUM NITRATE; SODIUM FLUORIDE 50; 2.43 mg/g; mg/g 10237-660_f707731f-161a-4b4c-b81e-f55c0024f358 10237-660 HUMAN OTC DRUG Sensitive Whitening with Baking Soda Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. POTASSIUM NITRATE; SODIUM FLUORIDE 50; 2.43 mg/g; mg/g 10237-661_f20a5fcf-a743-4885-b573-3673e0a3def0 10237-661 HUMAN OTC DRUG Arm and Hammer Orajel Sensitive Freshening with Flavor Burst Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.1 mg/g; mg/g 10237-662_0a94b85b-0766-4054-e054-00144ff8d46c 10237-662 HUMAN OTC DRUG Truly Radiant Whitening and Strengthening Rinse Sodium Fluoride 0.02% LIQUID ORAL 20141023 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE .2 mg/mL 10237-694_284b6a0f-7c77-424e-a2b8-d0569fe16afa 10237-694 HUMAN OTC DRUG Simply Saline Plus Wound Wash Antibacterial First Aid Antiseptic Benzethonium Chloride SPRAY TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333A Church & Dwight Co., Inc. BENZETHONIUM CHLORIDE .13 mL/mL 10237-695_8e5918a5-9a08-493d-9089-31ded025dd7d 10237-695 HUMAN OTC DRUG Simple Saline Cold Formula plus Menthol Luffa operculata, Sabadilla SPRAY NASAL 20110512 UNAPPROVED HOMEOPATHIC Church & Dwight Co., Inc. LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED 6; 6 [hp_X]/30mL; [hp_X]/30mL 10237-696_0dc80cd5-cde6-45b4-8393-ebde6bf0abed 10237-696 HUMAN OTC DRUG Simple Saline plus Childrens Cold Formula plus Moisturizers Luffa operculata, Sabadilla SPRAY NASAL 20110512 UNAPPROVED HOMEOPATHIC Church & Dwight Co., Inc. LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED 6; 6 [hp_X]/30mL; [hp_X]/30mL 10237-697_e6f02d9a-f1b3-492c-8ad9-c53fa7e6458a 10237-697 HUMAN OTC DRUG Simply Saline Wound Wash Benzethonium Chloride 0.13% SPRAY TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333A Church & Dwight Co., Inc. BENZETHONIUM CHLORIDE 1 mg/13mL 10237-701_8c291ddd-1b0d-4d59-a660-f326ab20c1da 10237-701 HUMAN OTC DRUG Orajel Instant Pain Relief for Toothache Maximum Strength Oral Pain Reliever GEL TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE 200 mg/g 10237-702_d151b296-cb3a-47e8-a221-7f6a4308b7f7 10237-702 HUMAN OTC DRUG Orajel Instant Pain Relief Maximum Strength Benzocaine and Menthol CREAM TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE; MENTHOL 200; 2.5 mg/g; mg/g 10237-703_52266132-3a1c-471d-96a3-a8e1c0c4bdaf 10237-703 HUMAN OTC DRUG Orajel Maximum Strength Benzocaine LIQUID TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE .2 mL/mL 10237-704_f0b25a23-829e-41c4-8cdc-58faaf3c243f 10237-704 HUMAN OTC DRUG Orajel Instant Pain Relief Regular Strength Benzocaine GEL TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE 100 mg/g 10237-705_32eb752d-6253-4768-980f-b1e215becf89 10237-705 HUMAN OTC DRUG Orajel for Toothache Maximum Strength Benzocaine SWAB TOPICAL 20100811 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE .2 mL/mL 10237-706_f84b6693-8849-45c8-9395-681ff5885c5b 10237-706 HUMAN OTC DRUG Orajel Maximum Strength Benzocaine and Menthol CREAM TOPICAL 20100510 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE; MENTHOL 200; 2.5 mg/g; mg/g 10237-707_2c093d64-6433-4712-b639-90adc8cb8372 10237-707 HUMAN OTC DRUG Orajel Instant Pain Reliver for Canker Sores Extra Strength Pain Relief Benzocaine, Menthol GEL TOPICAL 20100729 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE; MENTHOL 150; 20 mg/g; mg/g 10237-708_2334b033-51b1-4f69-921d-d546aaf3638a 10237-708 HUMAN OTC DRUG Orajel Instant Pain Relief Maximum Strength Benzocaine GEL TOPICAL 20100611 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZALKONIUM CHLORIDE; BENZOCAINE; ZINC CHLORIDE .4; 200; 1 mg/g; mg/g; mg/g 10237-709_655a1dc1-321e-4202-a8b8-d657c7b5732a 10237-709 HUMAN OTC DRUG Orajel for All Mouth Sores Maximum Strength Benzocaine SWAB TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE .2 mL/mL 10237-714_a189bb64-5de9-4a9d-b140-0476cbab2e1b 10237-714 HUMAN OTC DRUG Orajel Instant Relief for Teething Pain Cooling Cucumber Benzocaine GEL TOPICAL 20100615 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE 75 mg/g 10237-719_5be76374-91b7-4f74-86e0-16a07ca17968 10237-719 HUMAN OTC DRUG Orajel Dry Mouth Moistruizing Glycerin GEL TOPICAL 20100721 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. GLYCERIN 180 mg/g 10237-720_9d4e6d0a-1b2d-4861-8952-3a7bbbdadbe6 10237-720 HUMAN OTC DRUG Orajel Antiseptic Rinse for Mouth Sores Hydrogen peroxide LIQUID ORAL 20100729 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. HYDROGEN PEROXIDE .015 mL/mL 10237-721_2f044f4a-9999-4b27-b7e7-645d4627ff3c 10237-721 HUMAN OTC DRUG Orajle Anti-Bacterial Rinse for Bleeding Gums Cetylpyridinium chloride LIQUID ORAL 20100730 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. CETYLPYRIDINIUM CHLORIDE .001 mL/mL 10237-722_2c22ca26-28f5-417c-ab47-69470dbf4c58 10237-722 HUMAN OTC DRUG Orajel Severe Toothache Maximum Strength Fast-Acting Formula Benzocaine LIQUID TOPICAL 20110321 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE .2 mL/mL 10237-724_17c9fdd0-022a-4098-ac0b-b5669db3a1b5 10237-724 HUMAN OTC DRUG Orajel Instant Pain Relief for Severe Toothache Maximum Strength Benzocaine and Menthol GEL TOPICAL 20100721 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE; MENTHOL 200; 5 mg/g; mg/g 10237-726_ca4b753c-3809-41ac-8a88-eb295743dda0 10237-726 HUMAN OTC DRUG Orajel for Codl Sores Relief and Concealer Allantoin Benzocaine Camphor CREAM TOPICAL 20100719 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. ALLANTOIN; BENZOCAINE; CAMPHOR (NATURAL); DIMETHICONE; MENTHOL; PETROLATUM 5; 200; 30; 20; 10; 640 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g 10237-727_9e107187-a29c-4e1c-8b4a-93d1d6f44e76 10237-727 HUMAN OTC DRUG Orajel Anticavity Sodium Fluoride GEL, DENTIFRICE DENTAL 20140101 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-728_493f60ce-a42c-4ce5-9970-9f50c2a57ae2 10237-728 HUMAN OTC DRUG Orajel Kids My Way Anticavity Toothpaste Sodium Fluoride GEL, DENTIFRICE DENTAL 20110201 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-735_0dccd6e6-ed89-4a49-8602-af731c6ef123 10237-735 HUMAN OTC DRUG Orajel Instant Relief for Teething Pain Longer Lasting Benzocaine GEL TOPICAL 20110322 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE 75 mg/g 10237-736_3355fb23-7837-4fa5-961f-76bed90b676c 10237-736 HUMAN OTC DRUG Orajel Instant Relief for Teething Pain Benzocaine SWAB TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE .075 mL/mL 10237-737_53fd1c5b-40d1-4977-87c7-ab7213cfdbf3 10237-737 HUMAN OTC DRUG Orajel Naturals FAst Relief for Teething Pain Eugenol GEL TOPICAL 20101215 OTC MONOGRAPH FINAL part356 Church & Dwight Co., Inc. EUGENOL 12 mg/g 10237-738_6ffc29ea-0ac2-4370-990c-dfcc08185f90 10237-738 HUMAN OTC DRUG Orajel Nighttime Instant Relief for Teething Pain Longer Lasting Extra Strength Benzocaine GEL TOPICAL 20100618 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE 100 mg/g 10237-739_1c8ff394-f120-4377-8c63-897eadcaddb6 10237-739 HUMAN OTC DRUG Orajel Instant Relief for Teething Pain Daytime Nighttime Twin Pack Benzocaine KIT 20110322 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. 10237-740_c3fbca88-f485-41b0-9efc-7b08d18dd51f 10237-740 HUMAN OTC DRUG Orajel Kids My Way Anticavity Toothpaste Sodium Fluoride GEL, DENTIFRICE DENTAL 20120201 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-741_8a56db8c-0ec2-455e-8e83-fe1ebd6a5d7e 10237-741 HUMAN OTC DRUG Orajel for Cold Sores Single Dose Benzalkonium Chloride, Benzocaine LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZALKONIUM CHLORIDE; BENZOCAINE .13; .5 mg/mL; mg/mL 10237-742_cbeb3113-8afc-484d-9172-7ff115be3aed 10237-742 HUMAN OTC DRUG Baby Orajel Naturals for Teething Pain Relief Calcarea phosphorica, Chamomilla, Coffea cruda GEL TOPICAL 20121201 UNAPPROVED HOMEOPATHIC Church & Dwight Co., Inc. ARABICA COFFEE BEAN; MATRICARIA RECUTITA; TRIBASIC CALCIUM PHOSPHATE 6; 6; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g 10237-743_5fda924c-842e-43af-98c2-a547150d514c 10237-743 HUMAN OTC DRUG Orajel Kids My Way Anticavity Sodium Fluoride GEL, DENTIFRICE DENTAL 20130201 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g 10237-744_2c225979-bfad-4db5-a29e-5a842bcb9629 10237-744 HUMAN OTC DRUG Baby Orajel Naturals for Teething Pain Relief Nighttime Formula Calcarea phosphorica, Chamomilla, Coffea cruda,Passiflora incarnata GEL TOPICAL 20131202 UNAPPROVED HOMEOPATHIC Church & Dwight Co., Inc. ARABICA COFFEE BEAN; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWER; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 10237-745_3fec0c2f-12a8-4e59-85f2-561838078fa2 10237-745 HUMAN OTC DRUG Orajel Instant Pain Relief Regular Benzocaine 10% GEL TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part356 Church Dwight Co., Inc. BENZOCAINE 100 mg/g 10237-746_62aa9807-d15c-45c8-a8c3-50a08d96123c 10237-746 HUMAN OTC DRUG Orajel Instant Pain Relief Maximum Benzocaine 20%, Benzalkonium Chloride GEL TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part356 Church Dwight Co., Inc. BENZALKONIUM CHLORIDE; BENZOCAINE 1; 200 mg/g; mg/g 10237-747_82c53552-1cd5-47a9-82db-8ca6398a57ca 10237-747 HUMAN OTC DRUG Orajel Instant Pain Relief Severe Benzocaine 20%, Menthol, Benzalkonium Chloride CREAM TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part356 Church Dwight Co., Inc. BENZALKONIUM CHLORIDE; BENZOCAINE; MENTHOL 1; 200; 25 mg/g; mg/g; mg/g 10237-748_319151fb-fce6-4103-8301-f8e4dabc2543 10237-748 HUMAN OTC DRUG Orajel Instant Pain Relief Severe PM Benzocaine 20%, Menthol, Benzalkonium Chloride CREAM TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part356 Church Dwight Co., Inc. BENZALKONIUM CHLORIDE; BENZOCAINE; MENTHOL 1; 200; 25 mg/g; mg/g; mg/g 10237-750_5c676c7b-40ff-4f6a-8ce8-57174ae3ad73 10237-750 HUMAN OTC DRUG Orajel for Cold Sores Benzocaine CREAM TOPICAL 20100727 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE; PETROLATUM 200; 744.4 mg/g; mg/g 10237-752_9ebbbd66-74a5-4b88-85ec-e405f7865241 10237-752 HUMAN OTC DRUG Orajel Instant Pain Relief Severe Benzocaine 20%, Menthol, Benzalkonium Chloride GEL TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part356 Church Dwight Co., Inc. BENZALKONIUM CHLORIDE; BENZOCAINE; MENTHOL 1; 200; 50 mg/g; mg/g; mg/g 10237-753_30928a98-5e42-446a-8bbd-f97a46560711 10237-753 HUMAN OTC DRUG Orajel Instant Pain Relief SEVERE Benzocaine 20% LIQUID TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE 200 mg/g 10237-754_dc7c9077-c480-4b5a-93c1-287d619bdb51 10237-754 HUMAN OTC DRUG Orajel Instant Pain Relief Maximum Benzocaine 20% LIQUID TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part356 Church Dwight Co., Inc. BENZOCAINE 200 mg/g 10237-755_e26a1ff7-ea87-4359-b9ab-14127bc9802d 10237-755 HUMAN OTC DRUG Orajel Instant Pain Relief MAXIMUM Benzocaine 20% LIQUID TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE 200 mg/g 10237-756_e8042ed5-8f86-4dbb-ac10-bbc1e6a4e4eb 10237-756 HUMAN OTC DRUG Orajel for Cold Sores Single Dose Benzalkonium Chloride, Benzocaine LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZALKONIUM CHLORIDE; BENZOCAINE .13; .5 mg/g; mg/g 10237-759_0607f088-d44f-2961-e054-00144ff8d46c 10237-759 HUMAN OTC DRUG Orajel Alcohol Free Antiseptic Rinse For All Mouth Sores Hydrogen Peroxide 1.5%, Menthol 0.1% LIQUID ORAL 20141101 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. HYDROGEN PEROXIDE; MENTHOL 1.5; 1 mL/mL; mg/mL 10237-760_06188d36-0d61-6ae6-e054-00144ff8d46c 10237-760 HUMAN OTC DRUG Orajel Antiseptic Rinse For All Mouth Sores Hydrogen Peroxide 1.5%, Menthol 0.1% LIQUID ORAL 20141101 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. HYDROGEN PEROXIDE; MENTHOL 1.5; 1 mL/mL; mg/mL 10237-800_0755a1d7-6ae8-4a83-aa0a-b63fc50c1d16 10237-800 HUMAN OTC DRUG UltraMax Invisible Solid Antiperspirant Deodorant Powder Fresh Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20030619 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 10237-801_c32f8836-4bfb-4edd-8bdd-b87cdf418d48 10237-801 HUMAN OTC DRUG UltraMax Invisible Solid Antiperspirant Deodorant Unscented Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20030619 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 10237-802_898b6d1f-0435-455b-8541-0cd67b3f2b3e 10237-802 HUMAN OTC DRUG UltraMax Invisible Solid Antiperspirant Deodorant Fresh Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20030619 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 10237-803_da474de7-cca2-4d79-9fb8-177370a5bf13 10237-803 HUMAN OTC DRUG UltraMax Invisible Solid Antiperspirant Deodorant Active Sport Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20030619 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 10237-804_4d57cf44-f441-44f4-9cd9-816138e3f1d1 10237-804 HUMAN OTC DRUG UltraMax Invisible Solid Antiperspirant Deodorant Cool Blast Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20030619 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 10237-805_23dcba0c-a991-4e60-ae82-459364e23618 10237-805 HUMAN OTC DRUG UltraMax Antiperspirant Deodorant Cool Blast Aluminum Zirconium Tetrachlorohydrex Gly GEL TOPICAL 20031201 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 10237-810_d7150430-0b1f-4027-bd48-69d4b1e16859 10237-810 HUMAN OTC DRUG Arrid XX Extra Extra Dry Antiperspirant Deodorant Regular Aluminum Zirconium Tetrachlorohydrex Gly 19% STICK TOPICAL 20011001 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 10237-811_b0b7651d-7755-409a-85ac-072e6de4907f 10237-811 HUMAN OTC DRUG Arrid XX Unscented Antiperspirant Deodorant Unscented Aluminum Zirconium Tetrachlorohydrex Gly 19% STICK TOPICAL 20011001 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 10237-812_a6686db1-ac0c-4d15-9ff0-f17f47a3fea8 10237-812 HUMAN OTC DRUG Arrid XX Extra Extra Dry Antiperspirant Deodorant Ultra Fresh Aluminum Zirconium Tetrachlorohydrex Gly 19% STICK TOPICAL 20011001 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 10237-813_b8139fde-d2ba-4345-aa43-71803de9dd48 10237-813 HUMAN OTC DRUG Arrid XX Extra Extra Dry Antiperspirant Deodorant Cool Shower Aluminum Zirconium Tetrachlorohydrex Gly 19% STICK TOPICAL 20011001 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 10237-814_e454dc48-e287-4a48-84ba-92bfc66bd278 10237-814 HUMAN OTC DRUG ARRID EXTRA DRY Regular Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20110422 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 246 mg/g 10237-815_63ee7a78-971f-44bc-88e4-5b05f7b1fbb4 10237-815 HUMAN OTC DRUG ARRID EXTRA EXTRA DRY XX Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20110422 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 246 mg/g 10237-816_f9a0de5a-bd45-47e2-9c9a-09ab9c9ee94b 10237-816 HUMAN OTC DRUG ARRID EXTRA EXTRA DRY XX Ultra Fresh Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20110422 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 246 mg/g 10237-817_02d280c5-c677-4660-831f-edb792cfd8f4 10237-817 HUMAN OTC DRUG ARRID EXTRA EXTRA DRY XX Morning Clean Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20110422 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 246 mg/g 10237-818_1a978675-7cc3-4d63-9742-b9193525513f 10237-818 HUMAN OTC DRUG ARRID EXTRA EXTRA DRY XX Cool Shower Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20110422 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 246 mg/g 10237-819_fb876048-13da-4ee8-b625-79fe9295ca5e 10237-819 HUMAN OTC DRUG ARRID EXTRA EXTRA DRY XX Ultra Clear Ultra Clean Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20110422 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 246 mg/g 10237-820_6869b920-6195-424c-986c-4495f3ce69cf 10237-820 HUMAN OTC DRUG ARRID EXTRA EXTRA DRY XX Ultra Clear Ultra Fresh Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20110422 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 246 mg/g 10237-825_27e1ada3-cf5f-439b-a25f-7102aaa85235 10237-825 HUMAN OTC DRUG ARRID EXTRA DRY Antiperspirant Deodorant Ultra Fresh Aluminum Zirconium Tetrachlorohydrex Gly GEL TOPICAL 20040928 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 10237-826_0494194d-2fa6-4ba7-ab3e-e6d8f821aed6 10237-826 HUMAN OTC DRUG ARRID EXTRA DRY Antiperspirant Deodorant Morning Clean Aluminum Zirconium Tetrachlorohydrex Gly GEL TOPICAL 20040928 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 10237-827_3ead8364-b220-431b-941d-ca391cec014a 10237-827 HUMAN OTC DRUG ARRID EXTRA DRY Antiperspirant Deodorant Cool Shower Aluminum Zirconium Tetrachlorohydrex Gly GEL TOPICAL 20040928 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 10237-828_1159db31-6a86-4d0a-9558-4a3d0e5e8644 10237-828 HUMAN OTC DRUG ARRID XX Extra Extra Dry Invisible Solid Antiperspirant Deodorant Cool Blast Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20040928 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 10237-831_4830a42f-6389-49a6-86d8-c27fe12dd3b3 10237-831 HUMAN OTC DRUG Ladys Choice Invisible Solid Antiperspirant Deodorant Powder Fresh Aluminum Chlorohydrate STICK TOPICAL 20020601 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 20 g/100g 10237-832_47ada0a5-875f-4642-a018-76306dd29809 10237-832 HUMAN OTC DRUG Ladys Choice Invisible Solid Antiperspirant Deodorant Shower Fresh Aluminum Chlorohydrate STICK TOPICAL 20020601 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 20 g/100g 10237-833_1fb6abed-bbca-4922-b0e0-d855a3ba7aa9 10237-833 HUMAN OTC DRUG Ladys Choice Invisible Solid Antiperspirant Deodorant Cucumber Melon Aluminum Chlorohydrate STICK TOPICAL 20030601 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 20 g/100g 10237-834_751da331-3679-4c5e-908b-1f7667c66852 10237-834 HUMAN OTC DRUG Ladys Choice Invisible Solid Antiperspirant Deodorant Coconut Lime Aluminum Chlorohydrate STICK TOPICAL 20040201 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 20 g/100g 10237-900_3c8fd1f1-f2f1-40ca-9403-3f231a40ca97 10237-900 HUMAN OTC DRUG UltraMax Roll On Antiperspirant Deodorant Powder Fresh Aluminum Zirconium Tetrachlorohydrex Gly LIQUID TOPICAL 20000728 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 21 g/100mL 10237-901_de45822e-ad74-4c22-8580-f91678082a83 10237-901 HUMAN OTC DRUG ARRID XX Roll On Antiperspirant Deodorant Regular Aluminum Chlorohydrate LIQUID TOPICAL 19960716 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 16 mL/100mL 10237-902_730ac944-ab19-44cd-bb1e-84ee655679f2 10237-902 HUMAN OTC DRUG ARRID Extra Dry Antiperspirant Deodorant Aluminum Sesquichlorohydrate 17% CREAM TOPICAL 19951108 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM SESQUICHLOROHYDRATE 170 mg/g 10237-903_f026645d-01bd-4737-a70c-c9f67a8cac4c 10237-903 HUMAN OTC DRUG Baby Orajel Naturals for Teething Pain Relief Calcarea phosphorica, Coffea cruda, Chamomilla TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20110615 UNAPPROVED HOMEOPATHIC Church & Dwight Co., Inc. ARABICA COFFEE BEAN; MATRICARIA RECUTITA; TRIBASIC CALCIUM PHOSPHATE 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 10237-906_cf00d122-5e7c-4efd-8446-0c5b22f51f19 10237-906 HUMAN OTC DRUG Carters Little Pills Sodium-Free Bisacodyl TABLET, DELAYED RELEASE ORAL 20110601 OTC MONOGRAPH NOT FINAL part334 Church & Dwight Co., Inc. BISACODYL 5 mg/1 10237-907_058be7e6-01cc-5cd6-e054-00144ff88e88 10237-907 HUMAN OTC DRUG Legatrin PM Acetaminophen, Diphenhydramine HCI TABLET ORAL 20141001 OTC MONOGRAPH NOT FINAL part343 Church & Dwight Co., Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 50 1/1; 1/1 10252-001_0b5e14d7-b982-4f94-9a2b-3055532e2e10 10252-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Coastal Welding Supply, Inc. OXYGEN 990 mL/L 10252-002_e1adfdb8-a567-45b5-87fe-addfc2ce22d4 10252-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Coastal Welding Supply, Inc. NITROGEN 990 mL/L 10258-101_4b6ee5cf-1250-4206-98ca-ee227fa9af4d 10258-101 HUMAN OTC DRUG OXYGENETIX OXYGENATING FOUNDATION ACNE CONTROL SALICYLIC ACID LOTION TOPICAL 20141221 OTC MONOGRAPH FINAL part333D COLONIAL DAMES CO LTD SALICYLIC ACID 2 g/100mL 10258-102_2b59d156-929b-47fc-aa3e-1a094e9d656e 10258-102 HUMAN OTC DRUG DR. KARRS ACNE-STATIN SALICYLIC ACID CREAM TOPICAL 20141221 OTC MONOGRAPH FINAL part333D COLONIAL DAMES CO LTD SALICYLIC ACID .5 g/100mL 10267-0064_d6192ba4-c0f7-42cf-aee1-31a6113ef190 10267-0064 HUMAN OTC DRUG Phenazo Phenozapyridine Hydrochloride TABLET ORAL 20111025 UNAPPROVED DRUG OTHER Contract Pharmacal Corp PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 10267-0220_fdb31c92-d163-46b2-bde7-b3b42a584d4c 10267-0220 HUMAN OTC DRUG APAP Acetaminophen TABLET ORAL 20010529 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacal Corp ACETAMINOPHEN 325 mg/1 10267-0490_6103d928-c030-42c6-bb97-03f4a6c10c17 10267-0490 HUMAN OTC DRUG Senna S Sennosides and Sodium Dioctylsulfosuccinate TABLET ORAL 20010605 OTC MONOGRAPH NOT FINAL part334 Contract Pharmacal Corp DOCUSATE SODIUM; SENNA LEAF 50; 8.5 mg/1; mg/1 10267-0546_a511f863-6b3e-4522-a683-39198fb68086 10267-0546 HUMAN OTC DRUG APAP extra strength Acetaminophen TABLET ORAL 20010117 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacal Corp ACETAMINOPHEN 500 mg/1 10267-0617_389e925e-b973-4bfb-91fb-c06312ccf0e9 10267-0617 HUMAN OTC DRUG APAP Extra Strength Acetaminophen CAPSULE ORAL 20010129 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacal Corp ACETAMINOPHEN 500 mg/1 10267-0835_5fa1d326-c82a-4f60-b204-b209e082f862 10267-0835 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl TABLET ORAL 20040101 OTC MONOGRAPH NOT FINAL part336 Contract Pharmacal Corp DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 10267-0836_5fa1d326-c82a-4f60-b204-b209e082f862 10267-0836 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl TABLET ORAL 20040101 OTC MONOGRAPH NOT FINAL part336 Contract Pharmacal Corp DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 10267-0997_600941aa-685b-417b-a211-f7d10aafa6ea 10267-0997 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET ORAL 20010124 OTC MONOGRAPH NOT FINAL part341 Contract Pharmacal Corp CHLORPHENIRAMINE MALEATE 4 mg/1 10267-1004_d08c7682-3fbc-408a-a0df-8e2563f66500 10267-1004 HUMAN OTC DRUG Pseudoephedrine Non drowsy formula Pseudoephedrine Hydrochloride TABLET ORAL 20010621 OTC MONOGRAPH FINAL part341 Contract Pharmacal Corp PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 10267-1006_c82df322-fce0-4bfa-b21b-a2e921611d81 10267-1006 HUMAN OTC DRUG Dimenhydrinate Dimenhydrinate TABLET ORAL 20010112 OTC MONOGRAPH NOT FINAL part336 Contract Pharmacal Corp DIMENHYDRINATE 50 mg/1 10267-1016_b611361f-53e0-403a-9c5c-cf8c7f07ad69 10267-1016 HUMAN OTC DRUG Pseudoephedrine Plus Pseudoephedrine Hydrochloride Chlorpherniamine Maleate TABLET ORAL 20010220 OTC MONOGRAPH FINAL part341 Contract Pharmacal Corp CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 60 mg/1; mg/1 10267-1122_f4a8921b-1b27-4768-887a-81bad872a378 10267-1122 HUMAN OTC DRUG Natural Senna Sennosides TABLET ORAL 20010124 OTC MONOGRAPH NOT FINAL part334 Contract Pharmacal Corp SENNOSIDES A AND B 8.6 mg/1 10267-1190_b2cde99f-4d6f-4bb3-8493-b18c198da4ef 10267-1190 HUMAN OTC DRUG APAP Acetaminophen TABLET ORAL 20010109 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacal Corp ACETAMINOPHEN 500 mg/1 10267-1211_19111cc3-0a37-403e-9c95-b6d2d6028a6f 10267-1211 HUMAN OTC DRUG PSYLDEX Psyllium Hydrophyilic Mucilloid POWDER, FOR SOLUTION ORAL 20010208 OTC MONOGRAPH NOT FINAL part334 Contract Pharmacal Corporation PSYLLIUM HUSK 3.4 g/5.8g 10267-1215_4f2e9749-8fd6-48f6-9708-d54a4480c719 10267-1215 HUMAN OTC DRUG Pseudoephedrine Non-drowsy formula Pseudoephedrine HCl TABLET ORAL 20010717 OTC MONOGRAPH NOT FINAL part341 Contract Pharmacal Corp PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 10267-1936_e5db613b-7f6b-4a9b-ad6b-438f2715b39a 10267-1936 HUMAN OTC DRUG SUGAR FREE PSYLDEX Psyllium Husks POWDER, FOR SOLUTION ORAL 20010124 OTC MONOGRAPH NOT FINAL part334 Contract Pharmacal Corporation PSYLLIUM HUSK 3.4 g/5.8g 10267-2529_3bbf44a9-435f-4421-8bf8-7e45a5769614 10267-2529 HUMAN OTC DRUG Broncho Dilate Ephedrine HCl Guaifenesin TABLET ORAL 20020213 OTC MONOGRAPH NOT FINAL part341 Contract Pharmacal Corp EPHEDRINE HYDROCHLORIDE; GUAIFENESIN 12.5; 200 mg/1; mg/1 10267-2688_28bd5af2-3d4d-4e12-8d8e-79b332f31d42 10267-2688 HUMAN OTC DRUG Psyldex Natural Vegetable Laxative Psyllium Husk POWDER, FOR SOLUTION ORAL 20090622 OTC MONOGRAPH NOT FINAL part334 Contract Pharmacal Corp PSYLLIUM HUSK 3.4 g/7g 10267-2691_165bf665-f291-440a-85c3-465ca14fcfe1 10267-2691 HUMAN OTC DRUG Meclizine Meclizine HCl TABLET ORAL 20010724 OTC MONOGRAPH NOT FINAL part336 Contract Pharmacal Corp MECLIZINE HYDROCHLORIDE 25 mg/1 10267-3206_11a2b58b-304c-4d79-920e-508701c3c19f 10267-3206 HUMAN OTC DRUG Meclizine Meclizine HCl TABLET ORAL 20010724 OTC MONOGRAPH NOT FINAL part336 Contract Pharmacal Corp MECLIZINE HYDROCHLORIDE 25 mg/1 10267-3846_0b788f51-8d49-48ac-88d0-6c3d35d2d178 10267-3846 HUMAN OTC DRUG ibuprofen ibuprofen TABLET ORAL 20141201 ANDA ANDA071265 Contract Pharmacal Corporation IBUPROFEN 200 mg/1 10267-3852_0b788f51-8d49-48ac-88d0-6c3d35d2d178 10267-3852 HUMAN OTC DRUG ibuprofen ibuprofen TABLET ORAL 20140115 ANDA ANDA071265 Contract Pharmacal Corporation IBUPROFEN 200 mg/1 10267-3909_0b788f51-8d49-48ac-88d0-6c3d35d2d178 10267-3909 HUMAN OTC DRUG ibuprofen ibuprofen TABLET ORAL 20141201 ANDA ANDA071265 Contract Pharmacal Corporation IBUPROFEN 200 mg/1 10271-101_2a4be57a-a3df-4aa5-be52-845b75e78b3b 10271-101 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate INJECTION SUBCUTANEOUS 20141215 ANDA ANDA200122 United Biomedical Inc., Asia TERBUTALINE SULFATE 1 mg/mL 10297-001_3dcc5ef6-55ef-41e2-b5c1-311805a004c7 10297-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19780102 NDA NDA205737 A OX Welding Supply Company Inc. OXYGEN 990 mL/L 10297-002_5196cda2-d2e9-47c9-88fb-dd73c68513b7 10297-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20120109 NDA NDA205738 A OX Welding Supply Company Inc. NITROGEN 990 mL/L 10304-463_8dbf18dd-6efd-49d4-992a-03125cef596d 10304-463 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000612 UNAPPROVED MEDICAL GAS Delille Oxygen Company OXYGEN 995 mL/L 10304-601_a05f32ae-07d4-4824-9003-e0b749081c78 10304-601 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20000612 UNAPPROVED MEDICAL GAS Delille Oxygen Company NITROGEN 999 mL/L 10337-061_af011455-7a16-46eb-9823-42ca3abdbc98 10337-061 HUMAN PRESCRIPTION DRUG Pamine methscopolamine bromide TABLET ORAL 19530409 NDA NDA008848 PharmaDerm a division of Fougera Pharmaceuticals Inc. METHSCOPOLAMINE BROMIDE 2.5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 10337-062_af011455-7a16-46eb-9823-42ca3abdbc98 10337-062 HUMAN PRESCRIPTION DRUG Pamine Forte methscopolamine bromide TABLET ORAL 20030325 NDA NDA008848 PharmaDerm a division of Fougera Pharmaceuticals Inc. METHSCOPOLAMINE BROMIDE 5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 10337-153_3f197472-3c39-480f-ae49-14105323cb4f 10337-153 HUMAN PRESCRIPTION DRUG PANDEL HYDROCORTISONE PROBUTATE CREAM TOPICAL 19970228 NDA NDA020453 PharmaDerm a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE PROBUTATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10337-162_967d2b52-603d-4811-bfe3-361e1083d91b 10337-162 HUMAN PRESCRIPTION DRUG Temovate clobetasol propionate OINTMENT TOPICAL 19851227 NDA NDA019323 PharmaDerm, A division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10337-163_967d2b52-603d-4811-bfe3-361e1083d91b 10337-163 HUMAN PRESCRIPTION DRUG Temovate clobetasol propionate CREAM TOPICAL 19851227 NDA NDA019322 PharmaDerm, A division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10337-301_c320a4d5-5cce-49e2-a699-b46834231f11 10337-301 HUMAN PRESCRIPTION DRUG TEMOVATE E clobetasol propionate CREAM TOPICAL 19940617 NDA NDA020340 PharmaDerm a division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10337-311_645d51d4-1785-48e1-8aff-53a6e69ec06a 10337-311 HUMAN OTC DRUG ENTSOL Sodium Chloride SPRAY NASAL 20000901 UNAPPROVED DRUG OTHER PharmaDerm, A division of Fougera Pharmaceuticals Inc. SODIUM CHLORIDE 30 mg/mL 10337-332_f7aca819-cbbd-46c5-8010-340396035a8e 10337-332 HUMAN PRESCRIPTION DRUG Cutivate fluticasone propionate CREAM TOPICAL 19901218 NDA NDA019958 PharmaDerm a division of Fougera Pharmaceuticals Inc. FLUTICASONE PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10337-358_0962f08b-ed17-4c44-b6b8-b8aeaebe202a 10337-358 HUMAN PRESCRIPTION DRUG Oxistat oxiconazole nitrate CREAM TOPICAL 19881230 NDA NDA019828 PharmaDerm a division of Fougera Pharmaceuticals Inc. OXICONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 10337-359_0962f08b-ed17-4c44-b6b8-b8aeaebe202a 10337-359 HUMAN PRESCRIPTION DRUG Oxistat oxiconazole nitrate LOTION TOPICAL 19920930 NDA NDA020209 PharmaDerm a division of Fougera Pharmaceuticals Inc. OXICONAZOLE NITRATE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 10337-395_6993c481-07f2-4942-840b-c57a586930d4 10337-395 HUMAN PRESCRIPTION DRUG ApexiCon E diflorasone diacetate CREAM TOPICAL 20021220 ANDA ANDA076263 PharmaDerm a division of Fougera Pharmaceuticals Inc. DIFLORASONE DIACETATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10337-434_9142474e-2513-4429-9fe8-772e2d277f02 10337-434 HUMAN PRESCRIPTION DRUG Cutivate fluticasone propionate LOTION TOPICAL 20091005 NDA NDA021152 PharmaDerm, A division of Fougera Pharmaceuticals Inc. FLUTICASONE PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10337-450_d34b239e-d49e-4008-bfaa-4fc78c8998bd 10337-450 HUMAN PRESCRIPTION DRUG Veregen sinecatechins OINTMENT TOPICAL 20071214 NDA NDA021902 PharmaDerm a division of Fougera Pharmaceuticals Inc. SINECATECHINS 150 mg/g 10337-476_28a8f5ab-a540-4bd3-90c8-ce7a05c9dda9 10337-476 HUMAN PRESCRIPTION DRUG Tyzine TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION NASAL 19791130 20170131 ANDA ANDA086576 PharmaDerm A division of Fougera Pharmaceuticals Inc. TETRAHYDROZOLINE HYDROCHLORIDE 1 mg/mL 10337-477_28a8f5ab-a540-4bd3-90c8-ce7a05c9dda9 10337-477 HUMAN PRESCRIPTION DRUG Tyzine Pediatric TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION NASAL 19791130 20170131 ANDA ANDA086576 PharmaDerm A division of Fougera Pharmaceuticals Inc. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 10337-803_e2b35c82-e003-4d31-9ed8-5593eb08b733 10337-803 HUMAN PRESCRIPTION DRUG Solaraze diclofenac sodium GEL TOPICAL 20001016 NDA NDA021005 PharmaDerm, A division of Fougera Pharmaceuticals Inc. DICLOFENAC SODIUM 30 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10337-804_6c476a28-fba8-4e11-9f39-ceca33f3a76c 10337-804 HUMAN PRESCRIPTION DRUG Zonalon doxepin hydrochloride CREAM TOPICAL 19940401 NDA NDA020126 PharmaDerm A division of Fougera Pharmaceuticals Inc. DOXEPIN HYDROCHLORIDE 50 mg/g Tricyclic Antidepressant [EPC] 10337-808_2a911837-aef0-4b99-89a2-dce5ce94a330 10337-808 HUMAN OTC DRUG PrameGel pramoxine hydrochloride 1% and menthol 0.5% GEL TOPICAL 20060706 OTC MONOGRAPH NOT FINAL part347 PharmaDerm a division of Fougera Pharmaceuticals Inc. MENTHOL; PRAMOXINE HYDROCHLORIDE 5; 10 mg/mL; mg/mL 10337-815_26b9e8bd-a1aa-4293-aacc-927cc75149c5 10337-815 HUMAN PRESCRIPTION DRUG Adoxa doxycycline CAPSULE ORAL 20110601 ANDA ANDA065055 PharmaDerm a division of Fougera Pharmaceuticals Inc. DOXYCYCLINE 150 mg/1 10345-017_af78176e-97b9-4f5d-9db0-8a8883f0ce15 10345-017 HUMAN OTC DRUG LOCCITANE TITANIUM DIOXIDE CREAM TOPICAL 20100301 OTC MONOGRAPH FINAL part352 LOCCITANE TITANIUM DIOXIDE 115 mL/L 10345-018_73f6981e-71b2-4e21-bb28-69870a107ab5 10345-018 HUMAN OTC DRUG Angelica UV Shield SPF 40 TITANIUM DIOXIDE CREAM TOPICAL 20110910 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L TITANIUM DIOXIDE 115.2 mg/mL 10345-019_38a290f9-819c-492c-8e47-efc57434871c 10345-019 HUMAN OTC DRUG Angelica Protective SPF 15 OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20110912 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 25; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL 10345-020_d719d7f8-5aff-4001-9284-61605b95ea61 10345-020 HUMAN OTC DRUG Verdon Outdoor Moisturizer SPF 30 OCTOCRYLENE, OCTINOXATE, TITANIUM DIOXIDE, ENSULIZOLE CREAM TOPICAL 20110914 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 30; 75; 100; 43 mg/mL; mg/mL; mg/mL; mg/mL 10345-021_0066056a-c744-4130-ba55-df0df011d0c1 10345-021 HUMAN OTC DRUG L OCCITANE IMMORTELLE PRECIOUS PROTECTION BROAD SPECTRUM SPF 20 SUNSCREEN OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20110913 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 75; 50; 26 mg/mL; mg/mL; mg/mL; mg/mL 10345-022_5c5a4234-04f1-4cf2-9355-150420237375 10345-022 HUMAN OTC DRUG Sun Verbena Protective Gloss Protection OCTOCRYLENE, HOMOSALATE, AVOBENZONE LIPSTICK TOPICAL 20110910 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L AVOBENZONE; HOMOSALATE; OCTOCRYLENE 30; 60; 70 mg/mL; mg/mL; mg/mL 10345-023_f07b5873-b0d2-4bcc-8670-4b999aff46f3 10345-023 HUMAN OTC DRUG Sun Verbena Protective Body Protection SPF 15 OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20110914 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 23; 35; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL 10345-024_98c2e054-e290-47f0-b9fe-862701f3a48a 10345-024 HUMAN OTC DRUG L OCCITANE IMMORTELLE BRIGHTENING SHIELD SPF 40 SUNSCREEN TITANIUM DIOXIDE CREAM TOPICAL 20110913 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L TITANIUM DIOXIDE 115.2 mg/mL 10345-025_63d3d1ef-4625-4f5b-8fe7-0e4fa7496c0a 10345-025 HUMAN OTC DRUG Immortelle Brightening Hand Care SPF 15 OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20110913 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 75; 50; 26 mg/mL; mg/mL; mg/mL; mg/mL 10345-026_adbbe0e5-ea7c-4b82-a806-385a21c86a4f 10345-026 HUMAN OTC DRUG Shea Butter Protective SPF 20 OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20110914 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 75; 50; 26 mg/mL; mg/mL; mg/mL; mg/mL 10345-027_237f1ea9-ba71-433f-a68a-04ce9cd18272 10345-027 HUMAN OTC DRUG L OCCITANE IMMORTELLE BRIGHTENING HAND CARE BROAD SPECTRUM SPF 20 SUNSCREEN OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20121008 OTC MONOGRAPH FINAL part352 LABORATOIRES M&L AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL 10345-028_25114525-6d5b-4c39-bf68-741f629b57ea 10345-028 HUMAN OTC DRUG L OCCITANE SUBLIME BEAUTY BB LIGHT SPF 30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20130124 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L OCTINOXATE; TITANIUM DIOXIDE 75; 98 mg/mL; mg/mL 10345-029_b9b37e7c-6888-4b45-a635-e532afccd6c4 10345-029 HUMAN OTC DRUG L OCCITANE SUBLIME BEAUTY BB MEDIUM SPF 30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20130130 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L OCTINOXATE; TITANIUM DIOXIDE 75; 102.4 mg/mL; mg/mL 10345-030_d0f92238-b2b7-4b1b-af56-3ace2ca6dedb 10345-030 HUMAN OTC DRUG L OCCITANE FRESH BODY with Organic Verbena Extract SPF25 Broad Spectrum Sunscreen OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 75; 50; 27 mg/mL; mg/mL; mg/mL; mg/mL 10345-031_0867a01b-04fe-4814-af6d-6402257c1b6b 10345-031 HUMAN OTC DRUG L OCCITANE AU BRESIL - JENIPAPO Face Protection Veil SPF 30 Broad Spectrum TITANIUM DIOXIDE CREAM TOPICAL 20140319 OTC MONOGRAPH NOT FINAL part352 Laboratoires M&L TITANIUM DIOXIDE 86.4 mg/mL 10345-032_614fd560-2880-42c5-b8de-1a82cc930b7a 10345-032 HUMAN OTC DRUG L OCCITANE AU BRESIL - JENIPAPO Lip Gloss SPF 25 Broad Spectrum OCTOCRYLENE, HOMOSALATE, BUTYL METHOXYDIBENZOYLMETHANE/AVOBENZONE LIQUID TOPICAL 20140319 OTC MONOGRAPH NOT FINAL part352 Laboratoires M&L AVOBENZONE; HOMOSALATE; OCTOCRYLENE 30; 60; 70 mg/mL; mg/mL; mg/mL 10345-033_92df07d8-b98b-4040-a857-1cb10ae5875d 10345-033 HUMAN OTC DRUG L OCCITANE AU BRESIL - JENIPAPO Protecting Body Jelly Milk SPF 20 Broad Spectrum OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20140319 OTC MONOGRAPH NOT FINAL part352 Laboratoires M&L AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 75; 50; 27 mg/mL; mg/mL; mg/mL; mg/mL 10345-034_ac4d123f-f2ea-40de-8cd4-dcd9d3cd831e 10345-034 HUMAN OTC DRUG L OCCITANE AU BRESIL - JENIPAPO Protecting Body SPF 15 Broad Spectrum OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE OIL TOPICAL 20140319 OTC MONOGRAPH NOT FINAL part352 Laboratoires M&L AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 75; 50; 25 mg/mL; mg/mL; mg/mL; mg/mL 10345-035_0dbb1876-2452-4745-bebc-6e8725d81a47 10345-035 HUMAN OTC DRUG L OCCITANE Anti-Dandruff Sensitive Scalp PYRITHIONE ZINC SHAMPOO TOPICAL 20140305 OTC MONOGRAPH FINAL part358H Laboratoires M&L PYRITHIONE ZINC 10 mg/mL 10345-036_d7f099e6-6f69-449a-bfe5-f97e56ae5f88 10345-036 HUMAN OTC DRUG L OCCITANE CADE PROTECTIVE MOISTURIZING FLUID - FOR MEN BROAD SPECTRUM SPF 20 SUNSCREEN OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20140305 OTC MONOGRAPH NOT FINAL part352 Laboratoires M&L AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 75; 50; 27 mg/mL; mg/mL; mg/mL; mg/mL 10345-037_f1351353-88da-4ac2-afda-1eeb47146561 10345-037 HUMAN OTC DRUG LOCCITANE - IMMORTELLE PRECIOUS BB BROAD SPECTRUM SPF 30 01 FAIR TITANIUM DIOXIDE CREAM TOPICAL 20141118 OTC MONOGRAPH NOT FINAL part352 Laboratoires M&L TITANIUM DIOXIDE 153.2 mg/mL 10345-038_25e9683a-93e5-446c-919d-b05f28a51459 10345-038 HUMAN OTC DRUG LOCCITANE - IMMORTELLE PRECIOUS BB BROAD SPECTRUM SPF 30 02 LIGHT TITANIUM DIOXIDE CREAM TOPICAL 20141118 OTC MONOGRAPH NOT FINAL part352 Laboratoires M&L TITANIUM DIOXIDE 153.2 mg/mL 10345-039_d21851d8-e9f4-49a3-b024-94d76412d6c6 10345-039 HUMAN OTC DRUG LOCCITANE - IMMORTELLE PRECIOUS BB BROAD SPECTRUM SPF 30 03 MEDIUM TITANIUM DIOXIDE CREAM TOPICAL 20141118 OTC MONOGRAPH NOT FINAL part352 Laboratoires M&L TITANIUM DIOXIDE 153.2 mg/mL 10345-044_f08220a2-d4e5-46f7-8182-d6263b8931bd 10345-044 HUMAN OTC DRUG LOCCITANE - PIVOINE SUBLIME WITH PEONY CC BROAD SPECTRUM SPF 20 SUNSCREEN LIGHT TITANIUM DIOXIDE CREAM TOPICAL 20141121 OTC MONOGRAPH NOT FINAL part352 Laboratoires M&L. TITANIUM DIOXIDE 154.3 mg/mL 10345-045_492557e7-d007-4034-adb0-e8a11c852d37 10345-045 HUMAN OTC DRUG LOCCITANE - PIVOINE SUBLIME WITH PEONY CC BROAD SPECTRUM SPF 20 SUNSCREEN MEDIUM TITANIUM DIOXIDE CREAM TOPICAL 20141121 OTC MONOGRAPH NOT FINAL part352 Laboratoires M&L. TITANIUM DIOXIDE 151.4 mg/mL 10348-001_06fd9e72-8f61-423f-9d3b-91044b198794 10348-001 HUMAN OTC DRUG STUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 TITANIUM DIOXIDE LIQUID TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC TITANIUM DIOXIDE 4.7 mL/100mL 10348-002_94e364ba-9e7c-41f8-864d-dd3d70b2f24b 10348-002 HUMAN OTC DRUG CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 OCTINOXlATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 4; 2.5; 1.1 mL/100mL; mL/100mL; mL/100mL; mL/100mL 10348-003_886d9244-2d86-4538-9d4a-e799f7e19dc4 10348-003 HUMAN OTC DRUG SHEER FOCUS TINTED MOISTURIZER OCTINOXATE and ZINC OXIDE LIQUID TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC OCTINOXATE; ZINC OXIDE 7; 2.8 mL/100mL; mL/100mL 10348-004_914e2639-b8ad-40a3-9843-035cfab7f440 10348-004 HUMAN OTC DRUG smashbox PHOTO FINISH SPF 15 FOUNDATION PRIMER OCTINOXATE and OCTISALATE LOTION TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC OCTINOXATE; OCTISALATE 7.5; 5 mL/100mL; mL/100mL 10348-005_bef1a480-50b1-4c28-aa23-20a828184a76 10348-005 HUMAN OTC DRUG SMASHBOX HIGH DEFINITION HEALTHY FX FOUNDATION SPF 15 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC OCTINOXATE; TITANIUM DIOXIDE 5; 3.2 mL/100mL; mL/100mL 10348-006_aadd2583-2171-45f4-84b9-72aba03a4569 10348-006 HUMAN OTC DRUG SMASHBOX PHOTO FINISH FOUNDATION PRIMER SPF 20 AVOBENZONE, HOMOSALATE, and OCTISALATE LIQUID TOPICAL 20120527 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC AVOBENZONE; HOMOSALATE; OCTISALATE 2; 15; 5 mL/100mL; mL/100mL; mL/100mL 10348-008_ad8f88b4-d06b-4d59-9e5d-c7abe28a8e51 10348-008 HUMAN OTC DRUG PHOTO FINISH MORE THAN PRIMER BLEMISH CONTROL SALICYLIC ACID CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part333D SMASHBOX BEAUTY COSMETICS, INC SALICYLIC ACID .02 g/mL 10348-010_5dc69a7f-688f-4fd7-b156-e0f4a4ea54b6 10348-010 HUMAN OTC DRUG HALO HD FOUNDATION BROAD SPECTRUM SPF 15 OIL FREE OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC OCTINOXATE; TITANIUM DIOXIDE .05635; .03335 g/100mL; g/100mL 10348-011_33cabee0-6adc-4cd9-9e14-c8b161e806ec 10348-011 HUMAN OTC DRUG CAMERA READY BB EYES BS SPF 15 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130920 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .04592; .01568; .0168 g/100mL; g/100mL; g/100mL 10348-014_cd65cbe2-2569-4506-bf9e-0ada0a9e280b 10348-014 HUMAN OTC DRUG CAMERA READY CC BROAD SPECTRUM SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .08175; .0436; .02725; .0119 g/mL; g/mL; g/mL; g/mL 10356-100_068d1c83-7108-49f9-a3c8-7e26bb68371a 10356-100 HUMAN OTC DRUG Aquaphor Original Petrolatum OINTMENT TOPICAL 19750601 OTC MONOGRAPH FINAL part347 Beiersdorf Inc PETROLATUM 41 g/100g 10356-101_7b6cd9ff-426e-4914-93a5-44804e4abda9 10356-101 HUMAN OTC DRUG Aquaphor Healing Petrolatum OINTMENT TOPICAL 19910101 OTC MONOGRAPH FINAL part347 Beiersdorf Inc PETROLATUM 41 g/100g 10356-110_0d306489-336b-4a34-bde4-465c49b2e341 10356-110 HUMAN OTC DRUG Aquaphor Lip Repair and Protect Petrolatum, Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120401 OTC MONOGRAPH FINAL part347 Beiersdorf Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; PETROLATUM 3; 6.75; 4.5; 2; 5.4; 31 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 10356-322_3e99b52f-be60-419f-a4ff-e961e736f695 10356-322 HUMAN OTC DRUG Eucerin Everyday Protection Face Octinoxate, Zinc Oxide, Octisalate, Ensulizole, Titanium Dioxide LOTION TOPICAL 20090104 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc ENSULIZOLE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2; 7.5; 4.5; 2.38; 4.85 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 10356-325_7546f228-ee35-421f-b534-e1462791a7f2 10356-325 HUMAN OTC DRUG Eucerin Everyday Protection Body Homosalate, Octinoxate, Octisalate, Titanium Dioxide LOTION TOPICAL 20090104 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc HOMOSALATE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 5; 5; 4; 1 mL/100mL; mL/100mL; mL/100mL; mL/100mL 10356-326_17eb37af-83dd-4c9b-89bc-303c37fd9e92 10356-326 HUMAN OTC DRUG Eucerin Daily Protection Body Avobenzone, Homosalate, Octisalate LOTION TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; HOMOSALATE; OCTISALATE 2.7; 9; 4.5 g/100mL; g/100mL; g/100mL 10356-340_116e39a1-d072-445c-8f03-4b8c2421c75f 10356-340 HUMAN OTC DRUG Eucerin Q10 Anti-Wrinkle Sensitive Skin Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20010102 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 3; 3 g/100mL; g/100mL; g/100mL 10356-351_c52e82b8-b966-4b9b-bec7-800d065dff1d 10356-351 HUMAN OTC DRUG Eucerin Calming Itch Relief Treatment Menthol LOTION TOPICAL 20070102 OTC MONOGRAPH NOT FINAL part348 Beiersdorf Inc MENTHOL .1 mL/100mL 10356-352_a8941e58-61bc-46cf-bfa6-8212f72b63a7 10356-352 HUMAN OTC DRUG Eucerin Redness Relief Daily Perfecting Octinoxate, Octisalate, Titanium Dioxide LOTION TOPICAL 20090102 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 5; 4 mL/100mL; mL/100mL; mL/100mL 10356-365_a0953dfc-e379-4103-853c-f6f7b9708b43 10356-365 HUMAN OTC DRUG Eucerin Eczema Relief Body Oatmeal CREAM TOPICAL 20130715 OTC MONOGRAPH FINAL part347 Beiersdorf Inc OATMEAL 1 g/100g 10356-370_b1965929-f782-4966-bb63-2f8b3403922e 10356-370 HUMAN OTC DRUG Eucerin Eczema Relief Instant Therapy Oatmeal CREAM TOPICAL 20130915 OTC MONOGRAPH FINAL part347 Beiersdorf Inc OATMEAL 1 g/100g 10356-410_03c321c1-4917-4581-9657-4935633ecb82 10356-410 HUMAN OTC DRUG Nivea body Natural Tone Octinoxate, Avobenzone LOTION TOPICAL 20080105 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE .3; 1.8 mL/100mL; mL/100mL 10356-553_7f4aa9f4-20eb-4953-97d3-ceaec85c5d1c 10356-553 HUMAN OTC DRUG Nivea For Men Sensitive Octinoxate LOTION TOPICAL 20050601 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc OCTINOXATE 2 mL/100mL 10356-556_d52c3697-9272-4264-9f2a-5e98753adf9f 10356-556 HUMAN OTC DRUG Nivea For Men Protective Octinoxate, Avobenzone, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20060701 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 2; 6; 2; .35 mL/100mL; mL/100mL; mL/100mL; mL/100mL 10356-559_bd233a51-bcea-4965-bc12-5bc0f7d7e15e 10356-559 HUMAN OTC DRUG Nivea For Men Q10 Energy Avobenzone, Octinoxate, Oxybenzone LOTION TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE; OXYBENZONE 2; 6; 2 mL/100mL; mL/100mL; mL/100mL 10356-560_b8d33140-4d6a-4df4-ac66-757d2dfd3ec1 10356-560 HUMAN OTC DRUG Nivea For Men Age Defying Face Moisturizer Octisalate, Octocrylene, Avobenzone, Ensulizole LOTION TOPICAL 20100802 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE 2.5; 2; 4; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL 10356-565_a4183f9d-6d44-4750-a350-cde7404ebd06 10356-565 HUMAN OTC DRUG Nivea For Men Protective Octinoxate, Avobenzone, Oxybenzone LOTION TOPICAL 20120615 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE; OXYBENZONE 2; 6; 2 mL/100mL; mL/100mL; mL/100mL 10356-570_e2b478a2-73d4-49b8-8354-58b2878bcdb1 10356-570 HUMAN OTC DRUG Nivea For Men Q10 Energy Avobenzone, Octinoxate, Oxybenzone LOTION TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE; OXYBENZONE 2; 6; 2 mL/100mL; mL/100mL; mL/100mL 10356-571_b213f383-30f3-483a-8b67-6aa5f978ed63 10356-571 HUMAN OTC DRUG Nivea For Men Q10 Energy Avobenzone, Octinoxate, Oxybenzone LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE; OXYBENZONE 2.5; 7; 3 g/100mL; g/100mL; g/100mL 10356-575_4b56b83b-f23d-444d-bc53-594a7c9fd2f4 10356-575 HUMAN OTC DRUG Nivea Men Sensitive Protective Avobenzone, Octisalate, Octocrylene LOTION TOPICAL 20140915 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 4.7; 8.4 g/100mL; g/100mL; g/100mL 10356-801_3088ab32-fbc2-4227-8d3f-1b359ae4c704 10356-801 HUMAN OTC DRUG Nivea A Kiss of Protection Sun Protection Lip Care Octinoxate, Octocrylene, Oxybenzone, Titanium Dioxide STICK TOPICAL 20110212 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .0675; .075; .035; .025 g/g; g/g; g/g; g/g 10356-802_33f7d0e9-7c76-49db-aa10-e196532d1069 10356-802 HUMAN OTC DRUG Nivea A Kiss of Protection Lip Care Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone STICK TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.8; 6.7; 4.5; 2; 5.4 g/100g; g/100g; g/100g; g/100g; g/100g 10356-815_13ea2775-c31a-4ba5-b99e-6447ae6d9016 10356-815 HUMAN OTC DRUG NIVEA A Kiss of Smoothness Hydrating Lip Care Octinoxate and avobenzone STICK TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 Beiersdorf AVOBENZONE; OCTINOXATE 5; 30 mg/g; mg/g 10356-816_da29e2fd-e9be-4e1b-a181-8389270fc4b0 10356-816 HUMAN OTC DRUG NIVEA A Kiss of Smoothness Hydrating Lip Care Octinoxate, Avobenzone STICK TOPICAL 20110203 OTC MONOGRAPH NOT FINAL part352 Beiersdorf AVOBENZONE; OCTINOXATE .005; .03 g/g; g/g 10356-817_8f081f6b-3cdf-49f4-8714-4928ab5e57ef 10356-817 HUMAN OTC DRUG Nivea A Kiss of Smoothness Lip Care Avobenzone, Octinoxate, Octocrylene STICK TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE; OCTOCRYLENE 2.5; 6; 1.85 g/100g; g/100g; g/100g 10356-820_5622491b-25fc-4341-b1d6-43e54f9db094 10356-820 HUMAN OTC DRUG Nivea a Kiss of recovery octinoxate, avobenzone STICK TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 Beiersdorf AVOBENZONE; OCTINOXATE 10; 67.5 mg/g; mg/g 10356-821_43618ed5-e4e5-4c4c-a06d-63b453f2940b 10356-821 HUMAN OTC DRUG Nivea A Kiss of Recovery Medicated Lip Care Dimethicone, Avobenzone, Octinoxate STICK TOPICAL 20110214 OTC MONOGRAPH FINAL part347 Beiersdorf Inc AVOBENZONE; DIMETHICONE; OCTINOXATE .01; .012; .067 g/g; g/g; g/g 10356-822_a0df4dbe-5caf-4413-b9b0-bd1a82d3cfdc 10356-822 HUMAN OTC DRUG Nivea A Kiss of Recovery Medicated Lip Care Dimethicone, Avobenzone, Octinoxate, Octocrylene STICK TOPICAL 20130501 OTC MONOGRAPH FINAL part347 Beiersdorf Inc AVOBENZONE; DIMETHICONE; OCTINOXATE; OCTOCRYLENE 2.5; 1.2; 6; 1.8 g/100g; g/100g; g/100g; g/100g 10356-825_18f2cd4a-20bc-4881-8de8-0d1bd7fa08b7 10356-825 HUMAN OTC DRUG Nivea A Kiss of Flavor Strawberry Tinted Lip Care Avobenzone, octinoxate STICK TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 Beiersdorf AVOBENZONE; OCTINOXATE 10; 30 mg/g; mg/g 10356-826_556acf34-7aa8-4dcd-8e7b-6eb8333547ec 10356-826 HUMAN OTC DRUG Nivea A Kiss of Strawberry Fruity Lip Care Avobenzone, Octinoxate STICK TOPICAL 20110125 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE .01; .03 g/g; g/g 10356-831_726cb8d5-bbde-4835-b3bb-c1c85e13835b 10356-831 HUMAN OTC DRUG NIVEA for Men Replenishing Lip Balm Octinoxate STICK TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc OCTINOXATE 30 mg/g 10356-832_617b904a-6127-4c3f-8d58-127a4ff1833d 10356-832 HUMAN OTC DRUG NIVEA Men Replenishing Lip Balm Octinoxate, Avobenzone, Octocrylene STICK TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE; OCTOCRYLENE 2.5; 6; 1.8 g/100g; g/100g; g/100g 10356-835_430d13e0-94d7-4156-910e-604ccf5ad392 10356-835 HUMAN OTC DRUG Nivea A Kiss of Cherry Fruity Lip Care Avobenzone, Octinoxate STICK TOPICAL 20110203 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE .01; .03 g/g; g/g 10356-840_d4d680f4-5e47-4d66-9b69-7b4403c9a95b 10356-840 HUMAN OTC DRUG Nivea A Kiss of Shimmer Radiant Lip Care Avobenzone, Octinoxate STICK TOPICAL 20110203 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE .01; .03 g/g; g/g 10356-845_a667b1d6-561d-4723-9815-cf186f75547f 10356-845 HUMAN OTC DRUG Nivea A Kiss of Shine Natural Look Glossy Lip Care Avobenzone, Octinoxate LOTION TOPICAL 20110204 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE .027; .0675 mL/mL; mL/mL 10356-850_b50ce09b-e88f-4a35-9972-dd82f717de89 10356-850 HUMAN OTC DRUG Nivea A Kiss of Berry Swirl Vitamin Enriched Lip Care Avobenzone, Octinoxate STICK TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE .01; .03 g/g; g/g 10356-855_5d8749de-9484-484f-b96b-23160f798a70 10356-855 HUMAN OTC DRUG Nivea A Kiss of Intense Moisture Healing Medicated Lip Care Menthol, Petrolatum LOTION TOPICAL 20110214 OTC MONOGRAPH FINAL part347 Beiersdorf Inc MENTHOL; PETROLATUM .006; .31 mL/mL; mL/mL 10356-860_cf688b21-3cce-4603-a17c-ba50f6787e06 10356-860 HUMAN OTC DRUG Nivea A Kiss of Natural Volume Glossy Lip Care Avobenzone, Octinoxate LOTION TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE 2.7; 6.75 g/100mL; g/100mL 10356-865_3d79816a-54b1-4446-a42d-c9da69bee2b5 10356-865 HUMAN OTC DRUG Nivea A Kiss of Vitamin Swirl Antioxidant Enriched Lip Care Avobenzone, Octinoxate STICK TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE 1; 3 g/100g; g/100g 10358-1417_20df91c8-0e11-465a-b810-0e7a5c9a2785 10358-1417 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS NASAL; RESPIRATORY (INHALATION) 20040818 UNAPPROVED MEDICAL GAS AIRSENSE INC OXYGEN 995 mL/L 10361-778_c759668b-5cf1-b237-00c8-a5e4733b6f4c 10361-778 HUMAN PRESCRIPTION DRUG E-Z-Disk barium sulfate TABLET ORAL 20090201 UNAPPROVED DRUG OTHER E-Z-EM, INC. BARIUM SULFATE 700 mg/1 10370-101_85c38fcf-8da3-45a3-a6be-cba681e7540e 10370-101 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081125 ANDA ANDA077284 Par Pharmaceutical, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 10370-102_85c38fcf-8da3-45a3-a6be-cba681e7540e 10370-102 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070612 ANDA ANDA077284 Par Pharmaceutical, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 10370-107_c998c1a6-e168-4317-97a1-9d816932839c 10370-107 HUMAN PRESCRIPTION DRUG Ciprofloxacin Extended-Release Ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA078166 Par Pharmaceutical, Inc. CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 287.5; 212.6 mg/1; mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 10370-108_c998c1a6-e168-4317-97a1-9d816932839c 10370-108 HUMAN PRESCRIPTION DRUG Ciprofloxacin Extended-Release Ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA078166 Par Pharmaceutical, Inc. CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 574.9; 425.2 mg/1; mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 10370-116_ceb6d927-7271-44a9-8904-2a9480383544 10370-116 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Extended-Release Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111206 ANDA ANDA078148 Par Pharmaceutical, Inc. ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 10370-117_ceb6d927-7271-44a9-8904-2a9480383544 10370-117 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Extended-Release Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110414 ANDA ANDA078148 Par Pharmaceutical, Inc. ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 10370-169_287da0c4-4675-4705-92fb-8a19cf977a16 10370-169 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130319 ANDA ANDA202010 Par Pharmaceutical TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 10370-175_d728ac1a-d43a-4e40-b029-0796d261a628 10370-175 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Extended-Release Fluvoxamine Maleate CAPSULE, EXTENDED RELEASE ORAL 20130313 ANDA ANDA091476 Par Pharmaceutical, Inc. FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 10370-176_d728ac1a-d43a-4e40-b029-0796d261a628 10370-176 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Extended-Release Fluvoxamine Maleate CAPSULE, EXTENDED RELEASE ORAL 20130313 ANDA ANDA091476 Par Pharmaceutical, Inc. FLUVOXAMINE MALEATE 150 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 10370-195_397470a1-b152-488d-bdd6-a582a0256c82 10370-195 HUMAN PRESCRIPTION DRUG levetiracetam extended-release levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111004 ANDA ANDA091360 Anchen Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 10370-204_4b84993f-5722-489a-b04e-86654bef323b 10370-204 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110614 ANDA ANDA091520 Anchen Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 10370-209_eed9a876-2a3e-4cd6-a40f-3a3a0920af28 10370-209 HUMAN PRESCRIPTION DRUG Fenofibric Acid Delayed-Release Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20130718 ANDA ANDA201573 Par Pharmaceutical, Inc. CHOLINE FENOFIBRATE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 10370-210_eed9a876-2a3e-4cd6-a40f-3a3a0920af28 10370-210 HUMAN PRESCRIPTION DRUG Fenofibric Acid Delayed-Release Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20130718 ANDA ANDA201573 Par Pharmaceutical, Inc. CHOLINE FENOFIBRATE 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 10370-214_397470a1-b152-488d-bdd6-a582a0256c82 10370-214 HUMAN PRESCRIPTION DRUG levetiracetam extended-release levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111004 ANDA ANDA091360 Anchen Pharmaceuticals, Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 10370-219_e40fff13-de0f-4c48-9e16-3b392a9425d3 10370-219 HUMAN PRESCRIPTION DRUG Potassium Chloride Extended-Release Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20131226 ANDA ANDA202886 Par Pharmaceutical, Inc. POTASSIUM CHLORIDE 8 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 10370-220_e40fff13-de0f-4c48-9e16-3b392a9425d3 10370-220 HUMAN PRESCRIPTION DRUG Potassium Chloride Extended-Release Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20131226 ANDA ANDA202886 Par Pharmaceutical, Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 10370-221_7b94fa0b-1a0f-4c59-846f-95d824c892df 10370-221 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Extended-Release Tramadol Hydrochloride Extended-Release Tablets TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120627 ANDA ANDA200491 Par Pharmaceutical, Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 10370-222_7b94fa0b-1a0f-4c59-846f-95d824c892df 10370-222 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Extended-Release Tramadol Hydrochloride Extended-Release Tablets TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120627 ANDA ANDA200491 Par Pharmaceutical, Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 10370-223_7b94fa0b-1a0f-4c59-846f-95d824c892df 10370-223 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Extended-Release Tramadol Hydrochloride Extended-Release Tablets TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120627 ANDA ANDA200491 Par Pharmaceutical, Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 10370-257_9cdf3fb3-1a00-4ea6-af2c-9b43003ed4e2 10370-257 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Extended-Release Clonidine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130930 ANDA ANDA202984 Par Pharmaceutical CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 10370-268_2c018fee-3a4e-47a0-a60e-719b9b154807 10370-268 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CAPSULE ORAL 20121024 ANDA ANDA201687 Par Pharmaceutical, Inc. TRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 10370-302_9cdf3fb3-1a00-4ea6-af2c-9b43003ed4e2 10370-302 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Extended-Release Clonidine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130930 ANDA ANDA202984 Par Pharmaceutical CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 10370-390_f3a649c9-e22c-4b4f-9f60-3a424ca95402 10370-390 HUMAN PRESCRIPTION DRUG Nifedipine Extended-Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20140403 ANDA ANDA203126 Par Pharmaceutical, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 10370-391_f3a649c9-e22c-4b4f-9f60-3a424ca95402 10370-391 HUMAN PRESCRIPTION DRUG Nifedipine Extended-Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20140403 ANDA ANDA203126 Par Pharmaceutical, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 10370-392_f3a649c9-e22c-4b4f-9f60-3a424ca95402 10370-392 HUMAN PRESCRIPTION DRUG Nifedipine Extended-Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20140403 ANDA ANDA203126 Par Pharmaceutical, Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 10370-510_25c1edd8-87bb-4952-a18c-c4d32135f466 10370-510 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended-Release Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20090226 ANDA ANDA078445 Par Pharmaceutical, Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 10370-511_25c1edd8-87bb-4952-a18c-c4d32135f466 10370-511 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended-Release Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20090804 ANDA ANDA078445 Par Pharmaceutical, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 10412-0001_c40cbcf6-a060-4bd0-b6b2-1972a3c76b8b 10412-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Flint Welding Supply Company OXYGEN 99 L/100L 10412-0095_0042d2f1-4460-48af-a52a-cc0af1aa87b6 10412-0095 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19630101 UNAPPROVED MEDICAL GAS Flint Welding Supply Company NITROGEN 99.5 L/100L 10424-104_5920a057-a504-457a-b62b-6efd6221d06c 10424-104 HUMAN OTC DRUG SyDetox ALOE, ACTIVATED CHARCOAL, GOLDENSEAL, STRYCHNOS NUX-VOMICA SEED, and OKOUBAKA AUBREVILLEI BARK TABLET ORAL 20141015 UNAPPROVED HOMEOPATHIC Syntrion GmbH ACTIVATED CHARCOAL; ALOE; GOLDENSEAL; OKOUBAKA AUBREVILLEI BARK; STRYCHNOS NUX-VOMICA SEED 20; 20; 20; 20; 20 mg/1; mg/1; mg/1; mg/1; mg/1 10424-105_3957b73a-4c36-4747-a70d-6024c62fcd3c 10424-105 HUMAN OTC DRUG SyFungin CANDIDA PARAPSILOSIS TABLET ORAL 20141015 UNAPPROVED HOMEOPATHIC Syntrion GmbH CANDIDA PARAPSILOSIS 250 mg/1 10424-106_14cb3e26-5c7c-43b9-ae9b-7cc0d5c4663b 10424-106 HUMAN OTC DRUG SyGest CANDIDA PARAPSILOSIS and PENICILLIUM GLABRUM TABLET ORAL 20140110 UNAPPROVED HOMEOPATHIC Syntrion GmbH CANDIDA PARAPSILOSIS; PENICILLIUM GLABRUM 125; 125 mg/1; mg/1 10424-107_024e6e6a-c151-48f7-88e8-86c653bacdde 10424-107 HUMAN OTC DRUG SyImmune PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM TABLET ORAL 20140110 UNAPPROVED HOMEOPATHIC Syntrion GmbH PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 250 mg/1 10424-143_84b68f84-3145-4239-a29e-16fe470b7c4d 10424-143 HUMAN OTC DRUG SyDerm mucor circinelloides f. lusitanicus LOTION TOPICAL 20091024 UNAPPROVED HOMEOPATHIC Syntrion GmbH MUCOR CIRCINELLOIDES F. LUSITANICUS 6 [hp_X]/30mL 10424-144_020b9f93-3be4-4c0e-b738-f819ec6cc15e 10424-144 HUMAN OTC DRUG SyCircue mucor circinelloides f. lusitanicus LOTION TOPICAL 20091024 UNAPPROVED HOMEOPATHIC Syntrion GmbH MUCOR CIRCINELLOIDES F. LUSITANICUS 6 [hp_X]/30mL 10424-145_288896da-0a95-4487-ae90-5369d098d861 10424-145 HUMAN OTC DRUG SyReflux penicillium roqueforti TABLET ORAL 20110121 UNAPPROVED HOMEOPATHIC Syntrion GmbH PENICILLIUM ROQUEFORTI 6 [hp_X]/1 10424-146_f9ead239-5555-4d24-8a32-5fa78f2db9ef 10424-146 HUMAN OTC DRUG SyAllgen Penicillium Glabrum SPRAY NASAL 20110225 UNAPPROVED HOMEOPATHIC Syntrion GmbH PENICILLIUM GLABRUM 6 [hp_X]/20mL 10424-147_90a665aa-dd56-480a-b1d6-3b215d286453 10424-147 HUMAN OTC DRUG SyAllgen Penicillium Glabrum LOTION TOPICAL 20110225 UNAPPROVED HOMEOPATHIC Syntrion GmbH PENICILLIUM GLABRUM 6 [hp_X]/30mL 10424-148_a994e52f-d883-47d9-b292-a8e58948399b 10424-148 HUMAN OTC DRUG SyImmune Penicillium Chrysogenum Var. Chrysogenum SPRAY NASAL 20110307 UNAPPROVED HOMEOPATHIC Syntrion GmbH PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 4 [hp_X]/20mL 10424-149_59ad2766-c0cf-4c1a-a92b-d0b2ac3b51e9 10424-149 HUMAN OTC DRUG SyCircue mucor racemosus SPRAY NASAL 20110307 UNAPPROVED HOMEOPATHIC Syntrion GmbH MUCOR RACEMOSUS 6 [hp_X]/20mL 10424-150_1c2fa440-db72-491a-9ddb-da40889d1e66 10424-150 HUMAN OTC DRUG SyDerm Complex mucor racemosus and penicillium chrysogenum var. chrysogenum SPRAY ORAL 20110711 UNAPPROVED HOMEOPATHIC Syntrion GmbH MUCOR RACEMOSUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 6; 6 [hp_X]/20mL; [hp_X]/20mL 10424-151_9f225478-dfed-4c06-a7ca-89a6520c2dc4 10424-151 HUMAN OTC DRUG SyFungin candida parapsilosis SPRAY NASAL 20110711 UNAPPROVED HOMEOPATHIC Syntrion GmbH CANDIDA PARAPSILOSIS 6 [hp_X]/20mL 10424-152_35a5da1c-8509-4f42-b7d7-6882ae229d61 10424-152 HUMAN OTC DRUG SyGest candida parapsilosis and penicillium glabrum SPRAY ORAL 20110711 UNAPPROVED HOMEOPATHIC Syntrion GmbH CANDIDA PARAPSILOSIS; PENICILLIUM GLABRUM 6; 6 [hp_X]/20mL; [hp_X]/20mL 10424-153_1205256b-a6ae-439d-9edb-9986b49788bb 10424-153 HUMAN OTC DRUG SyResp 3-PHYTASE B (ASPERGILLUS NIGER) SPRAY ORAL 20110711 UNAPPROVED HOMEOPATHIC Syntrion GmbH 3-PHYTASE B (ASPERGILLUS NIGER) 6 [hp_X]/20mL 10424-154_ebc42310-d4c2-435c-b544-d14240ef5760 10424-154 HUMAN OTC DRUG SyImmune penicillium chrysogenum var. chrysogenum TABLET ORAL 20060518 UNAPPROVED HOMEOPATHIC Syntrion GmbH PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 4 [hp_X]/1 10424-155_e86f759c-f890-4e8d-92ac-e9d37e38a229 10424-155 HUMAN OTC DRUG SyRegule candida parapsilosis TABLET ORAL 20060518 UNAPPROVED HOMEOPATHIC Syntrion GmbH CANDIDA PARAPSILOSIS 4 [hp_X]/1 10424-156_e94b8d4b-bc32-4b56-a3b7-af768233b5d6 10424-156 HUMAN OTC DRUG SyAllgen Penicillium Glabrum TABLET ORAL 20060518 UNAPPROVED HOMEOPATHIC Syntrion GmbH PENICILLIUM GLABRUM 4 [hp_X]/1 10424-157_b54e09c0-d7bf-450e-a746-539db3413d63 10424-157 HUMAN OTC DRUG SyDetox aloe, activated charcoal, goldenseal, strychnos nux-vomica seed, and okoubaka aubrevillei bark SOLUTION/ DROPS ORAL 20080205 UNAPPROVED HOMEOPATHIC Syntrion GmbH ACTIVATED CHARCOAL; ALOE; GOLDENSEAL; OKOUBAKA AUBREVILLEI BARK; STRYCHNOS NUX-VOMICA SEED 6; 6; 6; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 10424-160_4403793a-d9bc-4865-88d7-f3ef8ed7aa49 10424-160 HUMAN OTC DRUG SyAllgen PENICILLIUM GLABRUM TABLET ORAL 20130215 UNAPPROVED HOMEOPATHIC Syntrion GmbH PENICILLIUM GLABRUM 4 [hp_X]/1 10424-161_09f0c475-acc3-4c51-8cbd-8b4942162e72 10424-161 HUMAN OTC DRUG SyCircue MUCOR RACEMOSUS TABLET ORAL 20130215 UNAPPROVED HOMEOPATHIC Syntrion GmbH MUCOR RACEMOSUS 4 [hp_X]/1 10424-162_005e6be5-bb38-422a-a665-91f67471de7c 10424-162 HUMAN OTC DRUG SyImmune PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM TABLET ORAL 20130215 UNAPPROVED HOMEOPATHIC Syntrion GmbH PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 4 [hp_X]/1 10424-163_82502704-48c1-440a-9b6c-23e577c630fd 10424-163 HUMAN OTC DRUG SyFungin CANDIDA PARAPSILOSIS TABLET ORAL 20130215 UNAPPROVED HOMEOPATHIC Syntrion GmbH CANDIDA PARAPSILOSIS 4 [hp_X]/1 10424-164_458d84a9-0478-4292-af04-365800c2294b 10424-164 HUMAN OTC DRUG SyGest Complex CANDIDA PARAPSILOSIS and PENICILLIUM GLABRUM TABLET ORAL 20130215 UNAPPROVED HOMEOPATHIC Syntrion GmbH CANDIDA PARAPSILOSIS; PENICILLIUM GLABRUM 6; 6 [hp_X]/1; [hp_X]/1 10424-165_ff219337-2698-429d-b11d-1551be918426 10424-165 HUMAN OTC DRUG SyInfect Complex PENICILLIUM GLABRUM and PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM TABLET ORAL 20130215 UNAPPROVED HOMEOPATHIC Syntrion GmbH PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM 6; 6 [hp_X]/1; [hp_X]/1 10424-166_45103e49-30fb-432c-a602-69fbccaa109a 10424-166 HUMAN OTC DRUG SyResp ASPERGILLUS NIGER VAR. NIGER TABLET ORAL 20130215 UNAPPROVED HOMEOPATHIC Syntrion GmbH ASPERGILLUS NIGER VAR. NIGER 6 [hp_X]/1 10424-167_7dd943ca-5f5a-4a98-87b5-4dc66ef8a56f 10424-167 HUMAN OTC DRUG SyReflux PENICILLIUM ROQUEFORTI TABLET ORAL 20130215 UNAPPROVED HOMEOPATHIC Syntrion GmbH PENICILLIUM ROQUEFORTI 6 [hp_X]/1 10451-001_dc304d38-306a-4c6c-8589-8f8ab7ec167c 10451-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19690101 UNAPPROVED MEDICAL GAS General Distributing Co. OXYGEN 992 mL/L 10451-002_f49d450e-3373-47a7-a556-1c17a1f55fc8 10451-002 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS General Distributing Company AIR 1000 mL/L 10451-003_213180ca-6e6b-41cc-88f1-44860b19f03a 10451-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS General Distributing Company NITROGEN 992 mL/L 10453-0123_fca3b6b5-3861-4869-a131-75197ae68b7e 10453-0123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040814 UNAPPROVED MEDICAL GAS Sunrise Medical Supply, Inc. dba American Medical Oxygen OXYGEN 99 L/100L 10454-710_fe96358c-e490-47bd-b992-3783022b7aff 10454-710 HUMAN PRESCRIPTION DRUG Myobloc rimabotulinumtoxinB INJECTION, SOLUTION INTRAMUSCULAR 20001208 BLA BLA103846 Solstice Neurosciences, LLC RIMABOTULINUMTOXINB 2500 [USP'U]/.5mL Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] 10454-711_fe96358c-e490-47bd-b992-3783022b7aff 10454-711 HUMAN PRESCRIPTION DRUG Myobloc rimabotulinumtoxinB INJECTION, SOLUTION INTRAMUSCULAR 20001208 BLA BLA103846 Solstice Neurosciences, LLC RIMABOTULINUMTOXINB 5000 [USP'U]/mL Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] 10454-712_fe96358c-e490-47bd-b992-3783022b7aff 10454-712 HUMAN PRESCRIPTION DRUG Myobloc rimabotulinumtoxinB INJECTION, SOLUTION INTRAMUSCULAR 20001208 BLA BLA103846 Solstice Neurosciences, LLC RIMABOTULINUMTOXINB 10000 [USP'U]/2mL Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] 10477-0805_5d666c11-2174-4c58-bfe7-4fb5e452e2c2 10477-0805 HUMAN OTC DRUG Antioxidant Daily Protectant SPF 50 Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20040301 OTC MONOGRAPH NOT FINAL part352 Goodier Cosmetics LP AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 4; 1.5 g/100g; g/100g; g/100g; g/100g 10477-0807_aee9210b-bbab-4a5e-9db2-fdd177d287b8 10477-0807 HUMAN OTC DRUG Antioxidant Daily Protectant SPF 30 Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20071219 OTC MONOGRAPH NOT FINAL part352 Goodier Cosmetics LP AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 4; 1.5 g/100g; g/100g; g/100g; g/100g 10477-0809_79cc2696-599c-47c1-9528-dd10850145b2 10477-0809 HUMAN OTC DRUG Antioxidant Daily Protectant SPF 45 Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20040301 OTC MONOGRAPH NOT FINAL part352 Goodier Cosmetics LP AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 4; 1.5 g/100g; g/100g; g/100g; g/100g 10477-0999_7dafa65a-aae0-46db-b43e-b61cad881265 10477-0999 HUMAN OTC DRUG Daily Wear SPF 20 Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20060530 OTC MONOGRAPH NOT FINAL part352 Goodier Cosmetics LP AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 7.5; 4; 1.5 g/100g; g/100g; g/100g; g/100g 10477-1261_09436ed8-bbe6-4aa2-ae8d-f37c9b94ede9 10477-1261 HUMAN OTC DRUG SPF 30 Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20030530 OTC MONOGRAPH NOT FINAL part352 Goodier Cosmetics, LP AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 1.5; 7.5; 5; 5 g/100g; g/100g; g/100g; g/100g 10477-2627_cfc06532-2c88-4de7-9c63-2cbba8f59817 10477-2627 HUMAN OTC DRUG Tinted SPF 45 Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20071201 OTC MONOGRAPH NOT FINAL part352 Goodier Cosmetics, LP OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 2 g/100g; g/100g; g/100g 10477-5601_e2361855-825f-45bf-a426-b1df12d42234 10477-5601 HUMAN OTC DRUG Tinted Moisturizer SPF 45 Matte Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Goodier Cosmetics LP OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 5; 3; 4; 3 g/100g; g/100g; g/100g; g/100g 10477-7603_dbc52bc6-a04f-4b43-9706-aa43283c89af 10477-7603 HUMAN OTC DRUG Tinted Moisturizer Matte Broad Spectrum SPF 45 octinoxate, octisalate, titanium dioxide, zinc oxide CREAM TOPICAL 20130622 OTC MONOGRAPH NOT FINAL part352 Goodier Cosmetics LP OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 5.5; 3.5; 4; 3 g/100g; g/100g; g/100g; g/100g 10477-7720_48f59516-2997-49bb-876c-22d4bca23012 10477-7720 HUMAN OTC DRUG Daily Moisturizing Antioxidant SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate CREAM TOPICAL 20130626 OTC MONOGRAPH NOT FINAL part352 Goodier Cosmetics LP AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 3; 3; 7.5; 4 g/100g; g/100g; g/100g; g/100g 10477-7749_32a44afd-0085-44ef-85ab-c515228837bd 10477-7749 HUMAN OTC DRUG Tinted Moisturizer Broad-Spectrum SPF 45 Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part352 Goodier Cosmetics LP OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 3.5; 3 g/100g; g/100g; g/100g; g/100g 10481-0111_48e2e8d2-dbcc-46b8-8e30-15931d5240d7 10481-0111 HUMAN PRESCRIPTION DRUG LUGOLS SOLUTION LUGOLS LIQUID TOPICAL 20100201 UNAPPROVED DRUG OTHER Gordon Laboratories IODINE .4 g/g 10481-0112_49a2555d-073f-4c02-8dc1-fdd42396cad4 10481-0112 HUMAN PRESCRIPTION DRUG MONSELS SOLUTION FERRIC SUBSULFATE LIQUID TOPICAL 20111207 UNAPPROVED DRUG OTHER Gordon Laboratories FERRIC SUBSULFATE .21 g/g 10481-0112_4e54728c-f319-4f6a-8c99-dd9969a4ab41 10481-0112 HUMAN PRESCRIPTION DRUG MONSELS SOLUTION FERRIC SUBSULFATE LIQUID TOPICAL 20100209 UNAPPROVED DRUG OTHER Gordon Laboratories FERRIC SUBSULFATE .21 g/g 10481-1050_01307296-8964-41c1-b39e-1f5b66649e43 10481-1050 HUMAN PRESCRIPTION DRUG Formadon Formaldehyde LIQUID TOPICAL 20100621 UNAPPROVED DRUG OTHER Gordon Laboratories FORMALDEHYDE .1 mL/59mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC] 10481-1050_cfef96d7-7c09-46f3-8b72-aefbd135d632 10481-1050 HUMAN PRESCRIPTION DRUG Formadon Formaldehyde LIQUID TOPICAL 20100621 UNAPPROVED DRUG OTHER Gordon Laboratories FORMALDEHYDE .1 mL/59mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC] 10481-1051_3f250aee-ed5a-4d73-b3a0-34e9cb405eba 10481-1051 HUMAN PRESCRIPTION DRUG Silver Nitrate SILVER NITRATE LIQUID TOPICAL 20100714 UNAPPROVED DRUG OTHER Gordon Laboratories SILVER NITRATE .1 g/10g 10481-1052_873722ca-2147-47e8-a48f-3a9ad7990f2a 10481-1052 HUMAN PRESCRIPTION DRUG Silver Nitrate Silver Nitrate LIQUID TOPICAL 20100715 UNAPPROVED DRUG OTHER Gordon Laboratories SILVER NITRATE .025 g/g 10481-1053_ef6948dd-094f-4e33-97be-e55246476944 10481-1053 HUMAN PRESCRIPTION DRUG Silver Nitrate Silver Nitrate LIQUID TOPICAL 20100714 UNAPPROVED DRUG OTHER Gordon Laboratories SILVER NITRATE .25 g/10g 10481-3005_9d73475d-b995-402e-b64e-3811735604bb 10481-3005 HUMAN PRESCRIPTION DRUG GORDONS UREA 40 UREA OINTMENT TOPICAL 20100716 UNAPPROVED DRUG OTHER Gordon Laboratories UREA .4 g/g 10481-3006_b92631c2-5e63-4526-acdc-a2940145407b 10481-3006 HUMAN PRESCRIPTION DRUG SODIUM HYDROXIDE SODIUM HYDROXIDE LIQUID TOPICAL 20100716 UNAPPROVED DRUG OTHER Gordon Laboratories SODIUM HYDROXIDE .01 g/g 10481-3008_0e395df5-9282-4c8f-8452-f3e9d8e1f315 10481-3008 HUMAN PRESCRIPTION DRUG TRI-CHLOR Trichloroacetic Acid LIQUID TOPICAL 20100712 UNAPPROVED DRUG OTHER Gordon Laboratories TRICHLOROACETIC ACID .8 g/g 10481-3012_fdb68978-98c7-4814-abd3-df3d329a77d5 10481-3012 HUMAN PRESCRIPTION DRUG POTASSIUM HYDROXIDE POTASSIUM HYDROXIDE LIQUID TOPICAL 20100716 UNAPPROVED DRUG OTHER Gordon Laboratories POTASSIUM HYDROXIDE .05 g/g 10481-3015_223583ec-b53c-4191-8efe-03b177a2b5c4 10481-3015 HUMAN PRESCRIPTION DRUG Forma-Ray FORMALDEHYDE LIQUID TOPICAL 20100715 UNAPPROVED DRUG OTHER Gordon Laboratories FORMALDEHYDE .2 mL/59mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC] 10481-3015_ae86e612-b396-4f7b-8832-cfa367876e9a 10481-3015 HUMAN PRESCRIPTION DRUG Forma-Ray Formaldehyde LIQUID TOPICAL 20100715 UNAPPROVED DRUG OTHER Gordon Laboratories FORMALDEHYDE .2 mL/59mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC] 10482-001_ad16c35f-2f3a-4dc1-b8a7-45aa3e37f2f6 10482-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19750101 UNAPPROVED MEDICAL GAS R. N. Goss Gas Products Company OXYGEN 995 mL/L 10492-001_07eeb3fe-c1a5-497f-a7dd-1772eab46ca8 10492-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19800101 UNAPPROVED MEDICAL GAS Greco Gas Inc OXYGEN 995 mL/L 10511-3001_88747294-784f-4995-bc60-b46bd72ae895 10511-3001 HUMAN PRESCRIPTION DRUG CYSVIEW hexaminolevulinate hydrochloride KIT 20110901 NDA NDA022555 Photocure Inc. 10515-140_d0a2f64e-e474-4dd0-be29-35fce160db72 10515-140 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080215 ANDA ANDA063140 GC Hanford Manufacturing Company AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 10515-142_f8f11211-7284-4ca9-85e2-6a069f89c5b8 10515-142 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080215 ANDA ANDA063142 GC Hanford Manufacturing Company AMPICILLIN SODIUM 10 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 10515-145_d0a2f64e-e474-4dd0-be29-35fce160db72 10515-145 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100917 ANDA ANDA063145 GC Hanford Manufacturing Company AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 10515-146_d0a2f64e-e474-4dd0-be29-35fce160db72 10515-146 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080215 ANDA ANDA063146 GC Hanford Manufacturing Company AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 10515-772_d0a2f64e-e474-4dd0-be29-35fce160db72 10515-772 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080215 ANDA ANDA062772 GC Hanford Manufacturing Company AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 10526-001_fe4c9698-e254-4b93-8785-6f1ff2b36044 10526-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Haun Welding Supply, Inc. OXYGEN 990 L/L 10526-002_d2b67858-3d02-4ccf-a4f8-94ee53c06018 10526-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Haun Welding Supply, Inc. OXYGEN 990 L/L 10526-003_58817cbb-81ee-496c-b848-364363793a89 10526-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen LIQUID TOPICAL 19900101 UNAPPROVED MEDICAL GAS Haun Welding Supply, Inc. NITROGEN 990 L/L 10542-009_e84e70ed-a73e-41fd-bad0-9697deeab537 10542-009 HUMAN PRESCRIPTION DRUG Dialyvite Supreme D Ascorbic Acid, Cholecalciferol, Alpha-Tocopherol, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium TABLET, COATED ORAL 20100908 UNAPPROVED DRUG OTHER Hillestad Pharmaceuticals USA ALPHA-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; COBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENIUM; THIAMINE MONONITRATE; ZINC CITRATE 30; 100; 300; 10; 2000; 1; 3; 20; 25; 1.7; 70; 1.5; 15 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 10542-010_f1609a5e-8f2a-41bd-b0db-44456db84426 10542-010 HUMAN PRESCRIPTION DRUG Dialyvite Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid TABLET, COATED ORAL 19880801 UNAPPROVED DRUG OTHER Hillestad Pharmaceuticals USA ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; COBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE 100; 300; 10; 6; 1; 20; 10; 1.7; 1.5 mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 10542-011_dd2cf454-b667-45e4-9cf0-993411214110 10542-011 HUMAN PRESCRIPTION DRUG Dialyvite 5000 Ascorbic Acid, Tocopheryl Acid Succinate, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium TABLET, COATED ORAL 20080501 UNAPPROVED DRUG OTHER Hillestad Pharmaceuticals USA .ALPHA.-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; COBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENOCYSTEINE; THIAMINE MONONITRATE; ZINC CITRATE 30; 100; 300; 10; 2; 5; 20; 50; 1.7; 70; 1.5; 25 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1 Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 10542-012_af8941da-7591-412a-8347-ccd030571f69 10542-012 HUMAN PRESCRIPTION DRUG Dialyvite with Zinc Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc TABLET, COATED ORAL 20021001 UNAPPROVED DRUG OTHER Hillestad Pharmaceuticals USA ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; COBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC CITRATE 100; 300; 10; 6; 1; 20; 10; 1.7; 1.5; 50 mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 10542-014_e0a36f1f-f5ec-47f5-abd2-4b5c6d495579 10542-014 HUMAN PRESCRIPTION DRUG Dialyvite 3000 Ascorbic Acid, Tocopheryl Acid Succinate, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium TABLET, COATED ORAL 20040201 UNAPPROVED DRUG OTHER Hillestad Pharmaceuticals USA .ALPHA.-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; COBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENOCYSTEINE; THIAMINE MONONITRATE; ZINC CITRATE 30; 100; 300; 10; 1; 3; 20; 25; 1.7; 70; 1.5; 15 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1 Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 10544-001_e0113a0e-88e1-4a29-bb15-672a03861a55 10544-001 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 20100510 ANDA ANDA040159 Blenheim Pharmacal, Inc. MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 10544-002_17b18994-0790-4262-8680-8167fd7f88fc 10544-002 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20100520 NDA NDA013217 Blenheim Pharmacal, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 10544-003_dc71c5ae-d3c7-470b-9113-95bb7aa86664 10544-003 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20100611 ANDA ANDA078671 Blenheim Pharmacal, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-004_9f733f9e-cf40-40f7-96e5-9503293b20aa 10544-004 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20100611 ANDA ANDA065253 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 10544-005_26de9cce-3b1f-4a5f-b2b7-0ac5584d793a 10544-005 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20100616 ANDA ANDA076636 Blenheim Pharmacal, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10544-007_9396fce3-f88b-4714-9bee-158646fa9ec5 10544-007 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20100720 ANDA ANDA065271 Blenheim Pharmacal, Inc. AMOXICILLIN 500 mg/1 10544-009_39619a05-3d1b-454b-9356-3465c63735f6 10544-009 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20100813 ANDA ANDA076003 Blenheim Pharmacal, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 10544-010_fdd1e667-81eb-4023-b70b-5037015f905b 10544-010 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100819 ANDA ANDA074201 Blenheim Pharmacal, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-011_c8544f93-feab-405c-ab46-61803b486e99 10544-011 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100820 ANDA ANDA090705 Blenheim Pharmacal, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 10544-013_443e66c6-a144-4910-a175-db140d15ac20 10544-013 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20100908 ANDA ANDA065229 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 10544-014_e4370315-e6c1-40b7-a529-33f79ff1d819 10544-014 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100908 ANDA ANDA078558 Blenheim Pharmacal, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-016_ba7d1b7d-2922-4f13-a0d6-df49e336d10e 10544-016 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100915 ANDA ANDA075927 Blenheim Pharmacal, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-017_02acdeac-5f4e-4261-a318-c539c0c11972 10544-017 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20100915 ANDA ANDA040804 Blenheim Pharmacal, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 10544-019_38f4b146-eddb-4c0f-8e9a-2200ba0b756d 10544-019 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100924 ANDA ANDA075927 Blenheim Pharmacal, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-020_9fc0b42f-ecb7-4070-a18c-e57d5a53778a 10544-020 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20100928 ANDA ANDA062702 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 10544-021_82ccb8d4-ea91-428c-a1f2-9c7c5bc31cd9 10544-021 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20101004 ANDA ANDA065229 Blenheim Pharmacal, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 10544-023_f2a4a691-def0-4829-ab15-02d5d27e6421 10544-023 HUMAN PRESCRIPTION DRUG Phenazopyridine Phenazopyridine TABLET ORAL 20101022 UNAPPROVED DRUG OTHER Blenheim Pharmacal. Inc. PHENAZOPYRIDINE 200 mg/1 10544-025_bb6ce0ee-0d20-43d0-b3b7-78518fec1cf3 10544-025 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20101105 ANDA ANDA065152 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 10544-029_c1221ecf-31fc-453d-8f6c-3a97db853a05 10544-029 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20101210 ANDA ANDA074342 Blenheim Pharmacal, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 10544-032_3f30a7c7-5db4-426a-b96e-966d03fec82a 10544-032 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110131 ANDA ANDA040419 Blenheim Pharmacal, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII 10544-044_f4d9bd36-b960-47f6-afde-22f5012d419b 10544-044 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110504 ANDA ANDA075927 Blenheim Pharmacal, Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-047_d4424cb8-19eb-48b6-bfbd-08beb0e7c67b 10544-047 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110615 ANDA ANDA040807 Blenheim Pharmacal, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 10544-057_55447692-8928-47d9-b1ac-c997b431b722 10544-057 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20120627 ANDA ANDA062791 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 10544-065_24b0e72d-2dd3-4355-8ba4-6101b127a36b 10544-065 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20120118 ANDA ANDA078619 Blenheim Pharmacal, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 10544-072_3d3179d3-e2f0-4d4f-aef6-dc18b26fd4a7 10544-072 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20120330 ANDA ANDA071611 Blenheim Pharmacal, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 10544-079_fc393ceb-1bfa-4554-9f83-358af3853e94 10544-079 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20120627 ANDA ANDA076639 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 10544-082_d1b2f866-1d39-49b4-92db-2be2d8685cc6 10544-082 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120801 ANDA ANDA062713 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 10544-090_87c6d3e2-7c66-479b-abe8-551cb8913921 10544-090 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20121024 ANDA ANDA077918 Blenheim Pharmacal, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-092_57ab565c-87af-4732-a757-09ae9f42cd7c 10544-092 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20121205 ANDA ANDA090828 Blenheim Pharmacal, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 10544-095_5f7c046b-2789-4bc0-9839-441ea3c9e8d1 10544-095 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20130114 ANDA ANDA062396 Blenheim Pharmacal, Inc. DOXYCYCLINE HYCLATE 100 mg/1 10544-096_9d8e8cc9-6ddc-400f-aeed-b7e2db293f4d 10544-096 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20130116 ANDA ANDA062058 Blenheim Pharmacal, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 10544-098_f29290d0-5875-4022-ae17-2a9caa48f34b 10544-098 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20130311 ANDA ANDA087022 Blenheim Pharmacal, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 10544-099_293b6198-e96b-4213-87cd-4236fdd45576 10544-099 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20130318 ANDA ANDA040886 Blenheim Pharmacal, Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 10544-100_21c498e0-47f1-4958-9126-86ddde5f2d78 10544-100 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine acetaminophen and codeine phosphate TABLET ORAL 20131111 ANDA ANDA089805 Blenheim Pharmacal, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 10544-101_dd572eaf-b4d5-4bc9-b9b9-a648dd36402e 10544-101 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20110215 ANDA ANDA074578 Blenheim Pharmacal, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 10544-102_1217cc75-15cd-4c1b-8147-125d7db61bd7 10544-102 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20100311 ANDA ANDA074556 Blenheim Pharmacal, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 10544-103_b72b4fa3-0b41-43dd-b686-287db47b83c7 10544-103 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20100720 ANDA ANDA074556 Blenheim Pharmacal, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 10544-105_b8865243-db54-4a8f-bcb2-37ee869e48ba 10544-105 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130328 ANDA ANDA040412 Blenheim Pharmacal, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 10544-106_c1221ecf-31fc-453d-8f6c-3a97db853a05 10544-106 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100413 ANDA ANDA074342 Blenheim Pharmacal, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 10544-107_c1221ecf-31fc-453d-8f6c-3a97db853a05 10544-107 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100423 ANDA ANDA074342 Blenheim Pharmacal, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 10544-108_e3fa8c4d-8fd6-4742-b8cc-5518f9b48cb2 10544-108 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 20091216 ANDA ANDA087128 Blenheim Pharmacal, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 10544-109_44ed0507-a6e1-48ac-bd34-2b5ced777e4b 10544-109 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20100804 ANDA ANDA085966 Blenheim Pharmacal, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 10544-110_8f689b85-94ab-423e-94b6-de77fc212ea1 10544-110 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20100303 ANDA ANDA085968 Blenheim Pharmacal, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 10544-111_cfb04bc4-c90a-4896-bd78-413854190d45 10544-111 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20130328 ANDA ANDA091416 Blenheim Pharmacal, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-116_cd3179bd-28a3-4fb0-ba34-d8c8ba3b7267 10544-116 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20091221 ANDA ANDA040876 Blenheim Pharmacal, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 10544-117_b6d65767-99a5-481b-9a8d-74f28d4a516b 10544-117 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120423 ANDA ANDA062884 Blenheim Pharmacal, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 10544-119_3605609b-17cf-40f4-96a5-09e04a836dce 10544-119 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20100106 ANDA ANDA065344 Blenheim Pharmacal, Inc. AMOXICILLIN 875 mg/1 10544-127_a4613504-d341-48e2-bfa4-1cc1a6cbce28 10544-127 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20101021 ANDA ANDA077877 Blenheim Pharmacal, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 10544-129_6393856a-dfba-4360-a5d4-5e9de60441fa 10544-129 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20101101 ANDA ANDA040627 Blenheim Pharmacal, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 10544-131_c47fbc0b-c7c7-4002-8e0e-bb5b25be363e 10544-131 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20130830 ANDA ANDA078010 Blenheim Pharmacal, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 10544-136_d4424cb8-19eb-48b6-bfbd-08beb0e7c67b 10544-136 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20131001 ANDA ANDA040807 Blenheim Pharmacal, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 10544-145_4d78aeb7-2069-4de3-9e3e-8f64cd02172a 10544-145 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20100629 ANDA ANDA074424 Blenheim Pharmacal, Inc. CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 10544-146_9e9138ff-b3ea-4dba-9458-8a644a6a6171 10544-146 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20131111 ANDA ANDA075677 Blenheim Pharmacal, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 10544-149_6f0602c1-3369-44c5-a3d3-140bc191d96d 10544-149 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100104 ANDA ANDA077048 Blenheim Pharmacal, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 10544-150_0d2664cf-46e0-4e83-8e28-15450f90b474 10544-150 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100104 ANDA ANDA077048 Blenheim Pharmacal, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 10544-151_3b87feec-aea4-476a-a60b-6778a582abb8 10544-151 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20130930 ANDA ANDA077309 Blenheim Pharmacal, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 10544-158_065d29b4-d5c2-4ae2-bdb7-d32f1b1ea405 10544-158 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 20100408 ANDA ANDA070924 Blenheim Pharmacal, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 10544-159_df94605b-0121-4285-8b97-7aa349c28d93 10544-159 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100125 ANDA ANDA078218 Blenheim Pharmacal, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 10544-161_7785e1b6-c121-4f46-a591-7ddd09a2aeda 10544-161 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20100413 ANDA ANDA077749 Blenheim Pharmacal, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 10544-169_11f1bd08-cc5f-4b96-96ea-d97fc3102a39 10544-169 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20091222 ANDA ANDA062396 Blenheim Pharmacal, Inc. DOXYCYCLINE HYCLATE 100 mg/1 10544-179_5dcf0419-355b-4751-bf4c-2d45b1be93a6 10544-179 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET, FILM COATED ORAL 20130930 ANDA ANDA077045 Blenheim Pharmacal, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 10544-181_d334ae75-3268-4f6e-b01d-2359df4e62db 10544-181 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine hydrochloride CAPSULE ORAL 20091222 ANDA ANDA076001 Blenheim Pharmacal, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 10544-182_5dcf0419-355b-4751-bf4c-2d45b1be93a6 10544-182 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET, FILM COATED ORAL 20130930 ANDA ANDA077045 Blenheim Pharmacal, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 10544-185_1ec1a2d2-81a8-4b6d-ab02-62881d82facf 10544-185 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20101008 ANDA ANDA078787 Blenheim Pharmacal, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 10544-186_c3f02a0b-b418-438c-b25c-bfe17cda0848 10544-186 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100104 ANDA ANDA078428 Blenheim Pharmacal, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 10544-188_cc715a60-32e0-4d31-a1df-2a591a56d4e5 10544-188 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20131130 ANDA ANDA075185 Blenheim Pharmacal, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-189_df595412-7b9d-4fa2-a12d-e01f843abf4e 10544-189 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20130930 ANDA ANDA075185 Blenheim Pharmacal, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-192_0f25d2e1-522b-47d7-a5da-dc342c12a5ec 10544-192 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20100909 ANDA ANDA074223 Blenheim Pharmacal, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 10544-204_d181a083-f9d0-43e1-b980-99f947c93fdb 10544-204 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20131210 ANDA ANDA077309 Blenheim Pharmacal, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 10544-209_d360cdb2-78e7-45b3-a06a-6f19e2224a58 10544-209 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine TABLET, FILM COATED ORAL 20091228 ANDA ANDA088617 Blenheim Pharmacal, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 10544-210_52b17351-bfe0-406f-9569-990cc7f00422 10544-210 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine TABLET, FILM COATED ORAL 20100517 ANDA ANDA088618 Blenheim Pharmacal, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 10544-213_f6c40f58-a0bb-47b0-a9eb-f0973de3b5c0 10544-213 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100310 ANDA ANDA078558 Blenheim Pharmacal, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-214_8ad2d40e-f413-4354-b36c-ce1cd04a4c52 10544-214 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100428 ANDA ANDA078558 Blenheim Pharmacal, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-215_f6c40f58-a0bb-47b0-a9eb-f0973de3b5c0 10544-215 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100317 ANDA ANDA078558 Blenheim Pharmacal, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-218_9a0bdb14-7e19-4e87-b4f1-70017d60e234 10544-218 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20100309 ANDA ANDA087425 Blenheim Pharmacal, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] 10544-219_e2ed9eeb-e67d-485f-86cb-eb9061bd9d96 10544-219 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20131008 ANDA ANDA077091 Blenheim Pharmacal, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 10544-226_31a005d8-7b61-4cac-bac5-78b0c09d46ca 10544-226 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20131118 ANDA ANDA040808 Blenheim Pharmacal, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 10544-227_31a005d8-7b61-4cac-bac5-78b0c09d46ca 10544-227 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20131118 ANDA ANDA040808 Blenheim Pharmacal, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 10544-238_52dfc887-7e11-4507-8182-2118284d2402 10544-238 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20091216 ANDA ANDA077321 Blenheim Pharmacal, Inc. LISINOPRIL 10 mg/1 10544-239_ba16b206-e57f-4593-997b-4856244c5400 10544-239 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20091216 ANDA ANDA077321 Blenheim Pharmacal, Inc. LISINOPRIL 20 mg/1 10544-240_9d64a851-28b2-4006-b2a9-4f523b565c59 10544-240 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20100520 ANDA ANDA077321 Blenheim Pharmacal, Inc. LISINOPRIL 40 mg/1 10544-245_ecc5ff4e-9ce4-4778-9b92-c84f6b82b5b4 10544-245 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131115 ANDA ANDA076710 Blenheim Pharmacal, Inc. LEVOFLOXACIN 750 mg/1 10544-248_009797a6-5b91-42aa-ac9f-f0d2d0675624 10544-248 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130930 ANDA ANDA076172 Blenheim Pharmacal, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 10544-251_ddfead24-bddd-4d4c-be92-1e6913ce5e0b 10544-251 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100423 ANDA ANDA077944 Blenheim Pharmacal, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-252_d89d204c-cb62-4b4f-9692-6243a1526f07 10544-252 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100413 ANDA ANDA077944 Blenheim Pharmacal, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-259_11960c06-3cba-4d79-b865-1eea11e9d716 10544-259 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20100720 ANDA ANDA085159 Blenheim Pharmacal, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 10544-265_95f92e0a-1f85-43fe-9d15-ec4355d5caaf 10544-265 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100414 ANDA ANDA070033 Blenheim Pharmacal, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 10544-269_4d903d0d-d3ba-43c1-a454-501d0c9e8846 10544-269 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20131118 ANDA ANDA078203 Blenheim Pharmacal, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 10544-271_dc71c5ae-d3c7-470b-9113-95bb7aa86664 10544-271 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20131008 ANDA ANDA078671 Blenheim Pharmacal, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-273_c54513d2-ddbd-4ace-a48b-a4fd2d8f6bec 10544-273 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20100324 ANDA ANDA076009 Blenheim Pharmacal, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-275_8f1f748d-b9e7-4b2c-a778-ee36ff4712d3 10544-275 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20100322 ANDA ANDA078314 Blenheim Pharmacal, Inc. NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-276_8f1f748d-b9e7-4b2c-a778-ee36ff4712d3 10544-276 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20100317 ANDA ANDA078314 Blenheim Pharmacal, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-277_8f1f748d-b9e7-4b2c-a778-ee36ff4712d3 10544-277 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20091214 ANDA ANDA078250 Blenheim Pharmacal, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-278_8f1f748d-b9e7-4b2c-a778-ee36ff4712d3 10544-278 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100317 ANDA ANDA078250 Blenheim Pharmacal, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-279_ca892861-44a0-4c60-a354-12ff8114f31a 10544-279 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin (monohydrate/macrocrystals) CAPSULE ORAL 20100413 ANDA ANDA080043 Blenheim Pharmacal, Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 10544-287_a2968165-848e-4000-9cad-c71e251a07bf 10544-287 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20091208 ANDA ANDA087463 Blenheim Pharmacal, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10544-296_311edbda-9eaa-410c-9ec6-cd484278a5e2 10544-296 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20090909 ANDA ANDA062936 Blenheim Pharmacal, Inc. PENICILLIN V POTASSIUM 250 mg/1 10544-297_311edbda-9eaa-410c-9ec6-cd484278a5e2 10544-297 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20091229 ANDA ANDA062935 Blenheim Pharmacal, Inc. PENICILLIN V POTASSIUM 500 mg/1 10544-321_72767f57-15ae-4750-82d2-9ccfb35fa7a2 10544-321 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20080108 ANDA ANDA085159 Blenheim Pharmacal, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 10544-374_e3ab49fc-d7b4-451b-86dd-d92bf54c4636 10544-374 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 20080529 ANDA ANDA078273 Blenheim Pharmacal, Inc. HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10544-377_96006da6-d453-48c2-8648-7a76cd6954fb 10544-377 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20080529 ANDA ANDA040517 Blenheim Pharmacal, Inc. METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10544-378_96006da6-d453-48c2-8648-7a76cd6954fb 10544-378 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20080602 ANDA ANDA040517 Blenheim Pharmacal, Inc. METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10544-380_29f9fad9-cb49-47f3-ae1d-5e5563c17e06 10544-380 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20080528 ANDA ANDA077290 Blenheim Pharmacal, Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10544-381_29f9fad9-cb49-47f3-ae1d-5e5563c17e06 10544-381 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20080528 ANDA ANDA077290 Blenheim Pharmacal, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10544-394_e3ab49fc-d7b4-451b-86dd-d92bf54c4636 10544-394 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 20081008 ANDA ANDA078273 Blenheim Pharmacal, Inc. HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10544-425_5267b697-ad6b-40a9-b9d9-51f6f691f3fc 10544-425 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20090611 ANDA ANDA040545 Blenheim Pharmacal, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10544-436_a58e76e8-0645-4c40-a738-5015e88bd68c 10544-436 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140404 ANDA ANDA075360 Blenheim Pharmacal, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 10544-439_383fd4de-4d2a-42dc-9a15-48bee7efb0ba 10544-439 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20140122 ANDA ANDA077662 Blenheim Pharmacal, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 10544-447_a58e76e8-0645-4c40-a738-5015e88bd68c 10544-447 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140404 ANDA ANDA075360 Blenheim Pharmacal, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 10544-448_383fd4de-4d2a-42dc-9a15-48bee7efb0ba 10544-448 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20140122 ANDA ANDA077662 Blenheim Pharmacal, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 10544-464_4cd1701a-c4f2-429a-a4db-185ece4e9a58 10544-464 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20140122 ANDA ANDA086988 Blenheim Pharmacal, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 10544-489_e2a38cca-ce0e-4344-9fa1-11279c9f1aea 10544-489 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20131008 ANDA ANDA077627 Blenheim Pharmacal, Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 10544-503_7d7a65bd-ef86-4b09-94c2-a26c1aa2b227 10544-503 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20091222 ANDA ANDA065248 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 10544-508_e14b112a-d01a-4d96-ae6a-7c6466245809 10544-508 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20091216 ANDA ANDA088832 Blenheim Pharmacal, Inc. PREDNISONE 10 mg/1 10544-509_e14b112a-d01a-4d96-ae6a-7c6466245809 10544-509 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20100317 ANDA ANDA083677 Blenheim Pharmacal, Inc. PREDNISONE 20 mg/1 10544-525_5e1c3d52-8bb7-4819-8994-9972d7664c0d 10544-525 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20091216 ANDA ANDA076899 Blenheim Pharmacal, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 10544-531_e273cf85-8544-4ea3-8019-057611a85f55 10544-531 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20100407 ANDA ANDA076003 Blenheim Pharmacal, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 10544-533_004ddf52-9e87-44a4-97e2-3c3293f7cf8c 10544-533 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20100303 ANDA ANDA071525 Blenheim Pharmacal, Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 10544-534_83166335-99a1-4df0-9c95-5f31e9979a36 10544-534 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110401 ANDA ANDA071523 Blenheim Pharmacal, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 10544-541_3035088e-c702-4fbc-a024-16121a2f9b8a 10544-541 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100820 ANDA ANDA073568 Blenheim Pharmacal, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 10544-546_b6d65767-99a5-481b-9a8d-74f28d4a516b 10544-546 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20091214 ANDA ANDA062881 Blenheim Pharmacal, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 10544-549_2f1cd314-1433-43a7-be55-816675849d2f 10544-549 HUMAN PRESCRIPTION DRUG PRENATAL PLUS VITAMIN A ACETATE, BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, TABLET, FILM COATED ORAL 20101209 UNAPPROVED DRUG OTHER Blenheim Pharmacal, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BETA CAROTENE; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE 22; 120; 920; 200; 400; 2; 12; 27; 1; 20; 10; 3; 1.84; 3080; 25 mg/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 10544-558_ecc5ff4e-9ce4-4778-9b92-c84f6b82b5b4 10544-558 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131113 ANDA ANDA076710 Blenheim Pharmacal, Inc. LEVOFLOXACIN 500 mg/1 10544-564_c5ca3b2d-1d53-4be1-899c-49b398cdacb3 10544-564 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20100504 ANDA ANDA077912 Blenheim Pharmacal, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 10544-576_9eb17a92-feec-42ce-b7ca-86367e164cc8 10544-576 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20140122 ANDA ANDA076533 Blenheim Pharmacal, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 10544-584_c47fbc0b-c7c7-4002-8e0e-bb5b25be363e 10544-584 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20131220 ANDA ANDA078010 Blenheim Pharmacal, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 10544-585_40c0641a-e3c6-4314-929f-b0b162e75574 10544-585 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20140115 ANDA ANDA075743 Blenheim Pharmacal, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 10544-586_793b6b1d-54fd-4856-ab0b-899bb046a239 10544-586 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20140114 ANDA ANDA077443 Blenheim Pharmacal, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 10544-590_d10c81e5-ccfe-4977-9cb9-c7edcdda6dc8 10544-590 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20100303 ANDA ANDA060704 Blenheim Pharmacal, Inc. TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 10544-591_561bf8f9-7ab2-4606-9317-0210982135e9 10544-591 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100126 NDA NDA020553 Blenheim Pharmacal, Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10544-592_cd3179bd-28a3-4fb0-ba34-d8c8ba3b7267 10544-592 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20100304 ANDA ANDA040887 Blenheim Pharmacal, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 10544-593_4035c0a2-7dc1-4bc3-9446-e05614d0c38b 10544-593 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20100304 ANDA ANDA087022 Blenheim Pharmacal, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 10544-597_fbeea6f8-f60a-494c-8bdf-093e48be509e 10544-597 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 20110401 ANDA ANDA040161 Blenheim Pharmacal, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 10544-598_39a39188-a305-466f-8a8d-aaa329860ea0 10544-598 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 20100330 ANDA ANDA011722 Blenheim Pharmacal, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 10544-599_4bae713c-47eb-4cdd-b727-3b4ec81825ae 10544-599 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20100406 ANDA ANDA076758 Blenheim Pharmacal, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10544-600_4bae713c-47eb-4cdd-b727-3b4ec81825ae 10544-600 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20100406 ANDA ANDA076758 Blenheim Pharmacal, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10544-601_2027c67a-6460-4013-bc09-0b2fe84ba35a 10544-601 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20100423 ANDA ANDA073652 Blenheim Pharmacal, Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 10544-602_adbf74c6-22f0-4951-aa7f-80c3677705ca 10544-602 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20091230 ANDA ANDA040527 Blenheim Pharmacal, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 10544-603_a36b1389-0b15-4b35-a934-9702069d5314 10544-603 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET ORAL 20100517 ANDA ANDA076639 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 10544-604_2d70eace-cfbd-433f-a0cc-4c39f4c1d926 10544-604 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN Ciprofloxacin TABLET, FILM COATED ORAL 20100517 ANDA ANDA075593 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 10544-605_2d12d7b7-73ae-41b9-9a03-cecc9f4a5e97 10544-605 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED ORAL 20100517 ANDA ANDA075817 Blenheim Pharmacal, Inc. CIPROFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 10544-606_025bb816-e2c4-416d-bba4-fb833f8496d5 10544-606 HUMAN PRESCRIPTION DRUG Ciprofloxacin hydrochloride Ciprofloxacin hydrochloride TABLET ORAL 20100517 ANDA ANDA076089 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 10544-607_c496b063-27b8-4675-aafc-6b65dd5aee3e 10544-607 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN Ciprofloxacin TABLET, FILM COATED ORAL 20100517 ANDA ANDA075593 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 10544-608_912163f2-9b33-46ff-8357-a6bd69eedd75 10544-608 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET ORAL 20100517 ANDA ANDA076639 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 10544-610_c65bc1a8-0487-4442-ac14-2efbac887d15 10544-610 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20100517 ANDA ANDA077253 Blenheim Pharmacal, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 10544-613_eec94386-ca1a-4b51-8454-92746c89365e 10544-613 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100517 ANDA ANDA078558 Blenheim Pharmacal, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10544-617_0d70804f-e1b8-4acf-8a65-fcadbd1f87b4 10544-617 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20100517 ANDA ANDA065215 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 10544-618_18417b93-cfe9-4f53-86ab-afc912d0d06b 10544-618 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20100517 ANDA ANDA083426 Blenheim Pharmacal, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 10544-619_aeab7666-d9ce-47bd-92b2-b71112076fb2 10544-619 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20100517 ANDA ANDA065291 Blenheim Pharmacal, Inc. AMOXICILLIN 500 mg/1 10544-620_293b6198-e96b-4213-87cd-4236fdd45576 10544-620 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20100517 ANDA ANDA040875 Blenheim Pharmacal, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 10544-621_b93cc1aa-1a9a-4e1a-9f2e-a02bf14c4ff1 10544-621 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20100517 ANDA ANDA040777 Blenheim Pharmacal, Inc. ACETAMINOPHEN; OXYCODONE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10544-773_4cd1701a-c4f2-429a-a4db-185ece4e9a58 10544-773 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20140122 ANDA ANDA086989 Blenheim Pharmacal, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 10544-847_e2a38cca-ce0e-4344-9fa1-11279c9f1aea 10544-847 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20131008 ANDA ANDA077627 Blenheim Pharmacal, Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 10544-862_7382e434-9524-4a1d-b70f-86df3421daf6 10544-862 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20131008 ANDA ANDA075074 Blenheim Pharmacal, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10546-100_d4255df9-25b6-4373-9b04-827605029434 10546-100 HUMAN OTC DRUG NUMOTIZINE MENTHOL OINTMENT TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part348 Hobart Laboratories, Inc. MENTHOL 1.25 g/100g 10565-001_b9a20d50-6bb3-4457-9bf6-4c09eb49b0a9 10565-001 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20111013 OTC MONOGRAPH FINAL part333A Hydrox Laboratories HYDROGEN PEROXIDE 3 mL/100mL 10565-002_a11ecb70-698a-419d-b9e4-f3cc089c00e7 10565-002 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20110922 OTC MONOGRAPH FINAL part344 Hydrox Laboratories ISOPROPYL ALCOHOL 70 mL/100mL 10565-013_de5bd441-5fa7-44c9-a8fe-aa3c7fa97f8b 10565-013 HUMAN OTC DRUG Alcohol Isopropyl Alcohol GEL TOPICAL 20111205 OTC MONOGRAPH NOT FINAL part333A Hydrox Laboratories ISOPROPYL ALCOHOL 62 mL/100mL 10565-040_6921bb8a-2dea-4c02-b9cf-b8aca9d7051d 10565-040 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 20111221 OTC MONOGRAPH FINAL part347 Hydrox Laboratories WITCH HAZEL 86 mL/100mL 10565-066_12e4b0fc-6c33-40a5-89bb-da4d4458bea1 10565-066 HUMAN OTC DRUG Roll On Anti Perspirant Alcohol Free ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20111026 OTC MONOGRAPH FINAL part350 Hydrox Laboratories ALUMINUM CHLOROHYDRATE 10 mg/100mL 10565-067_a76600f3-e7b3-4221-964c-74e5964b797c 10565-067 HUMAN OTC DRUG Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE SPRAY TOPICAL 20111111 OTC MONOGRAPH NOT FINAL part350 Hydrox Laboratories ALUMINUM CHLOROHYDRATE 13 mg/100mL 10565-069_b0dd8958-ecdd-4b18-9824-7982c2bd873f 10565-069 HUMAN OTC DRUG Isopropyl Alcohol with Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20120112 OTC MONOGRAPH NOT FINAL part333A Hydrox Laboratories ISOPROPYL ALCOHOL 70 mL/100mL 10565-070_80080efb-f628-4b6d-bcc1-c62e81e11975 10565-070 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120213 OTC MONOGRAPH NOT FINAL part333A Hydrox Laboratories ISOPROPYL ALCOHOL 50 mL/100mL 10565-071_2c55d5cf-8164-466d-8f92-6ae0e4a78c66 10565-071 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120227 OTC MONOGRAPH NOT FINAL part333A Hydrox Laboratories ISOPROPYL ALCOHOL 91 mL/100mL 10565-072_55607f1d-545e-4190-ab1b-2adc8991dfb1 10565-072 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol GEL TOPICAL 20111129 OTC MONOGRAPH NOT FINAL part333A Hydrox Laboratories ALCOHOL 62 mL/100mL 10565-073_4ca823ab-83ac-45d1-8b81-192bef2e0dff 10565-073 HUMAN OTC DRUG Antibacterial Hand Triclosan SOAP TOPICAL 20111219 OTC MONOGRAPH NOT FINAL part333E Hydrox Laboratories TRICLOSAN .15 mL/1000mL 10565-074_a9e2c89a-f6d6-4632-9609-36cdb007c47b 10565-074 HUMAN OTC DRUG Anti-Perspirant Deodorant Roll-On Unscented Aluminum Chlorohydrate LIQUID TOPICAL 20120320 OTC MONOGRAPH FINAL part350 Hydrox Laboratories ALUMINUM CHLOROHYDRATE 10 mg/100mL 10565-075_cf335209-9007-40fc-85fa-b0e027ad5a68 10565-075 HUMAN OTC DRUG Instant Hand Sanitizer Unscented Alcohol GEL TOPICAL 20120321 OTC MONOGRAPH NOT FINAL part333A Hydrox Laboratories ALCOHOL 62 mL/100mL 10565-076_8808a8da-4ef0-4f80-8fdf-605d7e6a7def 10565-076 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol GEL TOPICAL 20120109 OTC MONOGRAPH NOT FINAL part333A Hydrox Laboratories ALCOHOL 62 mL/100mL 10565-467_ae0a43f1-fa98-4ccc-a07c-4f62d6116b89 10565-467 HUMAN OTC DRUG Instant Hand Sanitizer Kuretek Alcohol GEL TOPICAL 20120612 OTC MONOGRAPH FINAL part333A Hydrox Laboratories ALCOHOL 62 mL/100mL 10565-467_f0fb9e9e-3fc6-4b2a-a0a7-9f2954c098cc 10565-467 HUMAN OTC DRUG Instant Hand Sanitizer Kuretek Alcohol GEL TOPICAL 20120612 OTC MONOGRAPH FINAL part333A Hydrox Laboratories ALCOHOL 62 mL/100mL 10572-100_907b9c8d-6c74-4a60-8f34-c6447319834a 10572-100 HUMAN PRESCRIPTION DRUG PEG-3350 and Electrolytes Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride POWDER, FOR SOLUTION ORAL 20090701 NDA AUTHORIZED GENERIC NDA019011 Affordable Pharmaceuticals, LLC POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 236; 2.97; 6.74; 5.86; 22.74 g/4L; g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 10572-101_907b9c8d-6c74-4a60-8f34-c6447319834a 10572-101 HUMAN PRESCRIPTION DRUG PEG-3350 and Electrolytes Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride POWDER, FOR SOLUTION ORAL 20090701 NDA AUTHORIZED GENERIC NDA019011 Affordable Pharmaceuticals, LLC POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 236; 2.97; 6.74; 5.86; 22.74 g/4L; g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 10572-147_453b2824-794e-4495-a260-6efff7f101c3 10572-147 HUMAN PRESCRIPTION DRUG nizatidine nizatidine SOLUTION ORAL 20091218 NDA AUTHORIZED GENERIC NDA021494 Affordable Pharmaceuticals, LLC NIZATIDINE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 10572-302_dcd1e641-9925-4e25-a1f8-3c30f0839775 10572-302 HUMAN PRESCRIPTION DRUG PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride POWDER, FOR SOLUTION ORAL 20130208 NDA AUTHORIZED GENERIC NDA019797 Affordable Pharmaceuticals, LLC POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420; 1.48; 5.72; 11.2 g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 10572-400_16fd321d-f891-4083-99f7-26e2e122619c 10572-400 HUMAN PRESCRIPTION DRUG PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride POWDER, FOR SOLUTION ORAL 20130208 NDA AUTHORIZED GENERIC NDA019797 Affordable Pharmaceuticals, LLC POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420; 1.48; 5.72; 11.2 g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 10578-002_59617214-dcaf-4695-888d-bd516b3fa743 10578-002 HUMAN OTC DRUG Aloemint Skin Aid menthol OINTMENT TOPICAL 19950101 OTC MONOGRAPH FINAL part348 Indiana Botanic Gardens MENTHOL .31 g/100g 10578-003_bedaaf40-3496-4029-8f7e-fd2747f71008 10578-003 HUMAN OTC DRUG Homeopathic Burn White oxide of arsenic, pot marigold, spanish fly, stinging nettle CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARSENIC TRIOXIDE; CALENDULA OFFICINALIS FLOWER; LYTTA VESICATORIA; URTICA URENS 10; 10; 10; 10 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g 10578-004_1a91f2bb-35c0-4a5b-82c5-02a04be2aaaa 10578-004 HUMAN OTC DRUG Homeopathic Bruise Leopards bane, daisy, st. johns wort CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM 10; 10; 10 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g 10578-005_feb71f1b-b24b-4bac-8b1f-5a45b108be36 10578-005 HUMAN OTC DRUG Homeopathic Eczema White oxide of arsenic, barberry, club moss, arbor vitae CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; LYCOPODIUM CLAVATUM SPORE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g 10578-006_299016a0-9df9-4224-b8fb-8d3964480801 10578-006 HUMAN OTC DRUG Homeopathic Scar Pot marigold, bushmaster snake, black lead, oil of mustard seed CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ALLYLTHIOUREA; CALENDULA OFFICINALIS FLOWER; GRAPHITE; LACHESIS MUTA VENOM 10; 10; 10; 16 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g 10578-007_6e3d019e-006a-41e3-bd99-3ccbd938fd75 10578-007 HUMAN OTC DRUG Homeopathic Acne Potassium hydrate, calcium sulphide, poison nut, cuttlefish ink CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CALCIUM SULFIDE; CAUSTICUM; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g 10578-008_a6072d70-8a38-4af3-bb50-69ef78d4fb2d 10578-008 HUMAN OTC DRUG Homeopathic Athletes Foot Carbonate of barium, black lead, pure flint, arbor vitae CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens BARIUM CARBONATE; GRAPHITE; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g 10578-009_b47f0974-039f-4e18-b1a5-72b4fe282c58 10578-009 HUMAN OTC DRUG Undesine undecylenic acid, zinc undecylenate OINTMENT TOPICAL 19950101 OTC MONOGRAPH FINAL part333C Indiana Botanic Gardens UNDECYLENIC ACID; ZINC UNDECYLENATE 5; 20 g/100g; g/100g 10578-010_cb45796c-2421-4d74-856b-5aa253f34d50 10578-010 HUMAN OTC DRUG Homeopathic Weight Loss Formula Betula alba, Cimicifuga racemosa, Cratageus oxycantha, Equisetum hyemale, Rhamnus frangula, Solidago virgaurea, Adonis vernalis, Apocynum androsaemifolium, Chelidonium majus, Lycopodium clavatum, Scil TABLET ORAL 19970401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ADONIS VERNALIS; APOCYNUM ANDROSAEMIFOLIUM ROOT; BETULA PUBESCENS LEAF; BLACK COHOSH; CHELIDONIUM MAJUS; CRATAEGUS LAEVIGATA FRUIT; DRIMIA MARITIMA BULB; EQUISETUM HYEMALE; FRANGULA ALNUS BARK; LYCOPODIUM CLAVATUM SPORE; SOLIDAGO VIRGAUREA FLOWERING TOP 3; 3; 2; 2; 3; 2; 3; 2; 2; 3; 2 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-011_59a3d87a-3074-45f0-86fe-bcf0a154c9ba 10578-011 HUMAN OTC DRUG Homeopathic Joint Formula Benzoic acid, Bryonia alba, Ruta graveolens, Rhus toxicodendron, Causticum, Formic acid, Lithium carbonicum TABLET ORAL 20030101 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens BENZOIC ACID; BRYONIA ALBA ROOT; CAUSTICUM; FORMIC ACID; LITHIUM CARBONATE; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 3; 3; 6; 6; 6; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-012_dcfd302e-bead-44ad-ab84-a03b84aa1c9a 10578-012 HUMAN OTC DRUG Homeopathic Leg Cramp Formula Anacardium orientale, Cocculus indicus, Gelsemium sempervirens, Lycopodium clavatum, Causticum, Cuprum metallicum, Magnesia phosphorica TABLET ORAL 19980201 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ANAMIRTA COCCULUS SEED; CAUSTICUM; COPPER; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEMECARPUS ANACARDIUM JUICE 2; 4; 4; 3; 3; 4; 2 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-013_dfb9c3be-7005-4847-a9e6-12ae5ae3c76d 10578-013 HUMAN OTC DRUG Homeopathic Sciatica Formula Arnica montana, Hypericum perforatum, Gnaphalium, Kali iodatum, Magnesia phosphorica, Rhus toxicodendron TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARNICA MONTANA; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM IODIDE; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; TOXICODENDRON PUBESCENS LEAF 4; 5; 5; 5; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-014_44819e40-1ce9-42f7-8be7-6a75f30279bb 10578-014 HUMAN OTC DRUG Homeopathic Ringing Ear Formula China sulphuricum, Thiosinaminum, Petroselinum, Salicylic acid, Kali phosphoricum TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ALLYLTHIOUREA; PETROSELINUM CRISPUM; POTASSIUM PHOSPHATE, DIBASIC; QUININE SULFATE; SALICYLIC ACID 3; 3; 3; 6; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-015_5d99ee48-c2d2-4ebc-8daf-747dbbc13117 10578-015 HUMAN OTC DRUG Homeopathic Bladder Confidence Formula Belladonna, Canthris, Apis mellifica, Arnica montana, Allium cepa, Rhus aromatica, Equisetum hyemale TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; EQUISETUM HYEMALE; LYTTA VESICATORIA; ONION; RHUS AROMATICA ROOT BARK 6; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 10578-016_fb97279b-301f-4b0a-92b1-af8c4fb9bc9f 10578-016 HUMAN OTC DRUG Homeopathic Allergy Formula Allium cepa, Apis mellifica, Arsenicum album, Euphrasia officinalis, Nux vomica TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens APIS MELLIFERA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; ONION; STRYCHNOS NUX-VOMICA SEED 4; 4; 4; 4; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-017_b3c4748e-71c2-42cc-aa29-d0dbc9b8df34 10578-017 HUMAN OTC DRUG Homeopathic Hemorrhoid Horse chestnut, potassium hydrate, witch hazel, cramp bark CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CAUSTICUM; HORSE CHESTNUT; VIBURNUM OPULUS BARK; WITCH HAZEL 10; 10; 10; 10 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g 10578-018_86fc5482-9989-41b4-8a60-1fe028dee285 10578-018 HUMAN OTC DRUG Homeopathic Gas Relief Formula Carduus marianus, Chelidonium majus, Solidago virgaurea, Taraxacum officinalis, Chinchona officinalis, Hydrastis canadensis, Nux vomica TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; GOLDENSEAL; SILYBUM MARIANUM SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 3; 3; 3; 3; 3; 3; 3 [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1 10578-019_16079903-ee27-4084-9ddd-ddd74d82de2d 10578-019 HUMAN OTC DRUG Homeopathic Low Back Pain Formula Colocynthis, Antimonium tartrate, Kali carbonate, Bryonia, Nux vomica TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED 3; 4; 3; 6; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-020_3a5c0f68-badd-4ef2-b411-8ff5e2864f7c 10578-020 HUMAN OTC DRUG Homeopathic Rheumatism Barberry, potassium hydrate, buttercup, poison oak CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens BERBERIS VULGARIS ROOT BARK; CAUSTICUM; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g 10578-021_5abadf50-37ae-4fa7-aa36-84e194a69e1a 10578-021 HUMAN OTC DRUG Homeopathic Wart Sulphide of antimony, potassium hydrate, woody nightshade, arbor vitae CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ANTIMONY TRISULFIDE; CAUSTICUM; SOLANUM DULCAMARA TOP; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g 10578-022_f5e75b25-9668-4cd0-8fe5-5fd9b5257255 10578-022 HUMAN OTC DRUG Homeopathic Sinus Relief Formula Allium cepa, Belladonna, Euphrasia officinale, Hydrastis canadensis, Kali bechromate, Sambucus niger, Mercurius dulcis TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ATROPA BELLADONNA; CALOMEL; EUPHRASIA STRICTA; GOLDENSEAL; ONION; POTASSIUM DICHROMATE; SAMBUCUS NIGRA FLOWERING TOP 3; 6; 3; 3; 3; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-023_2338bdac-73af-4096-9a4f-bb7c6f0c04ad 10578-023 HUMAN OTC DRUG Homeopathic Stop Smoking Formula Daphne indica, Eugenia jambosa, Caladium seguinum, Staphysagria, Anacardium orientale, Nux vomica, Tabaccum TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; SEMECARPUS ANACARDIUM JUICE; STRYCHNOS NUX-VOMICA SEED; SYZYGIUM JAMBOS SEED; TOBACCO LEAF 4; 4; 4; 4; 4; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-024_e843efa5-359a-4cf2-9576-b44d590e682e 10578-024 HUMAN OTC DRUG Homeopathic Sleep Formula Avena sativa, Chamomilla vulgaris, Humulus lupulus, Passiflora incarnata, Coffea cruda, Ignatia amara TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; HOPS; MATRICARIA RECUTITA; PASSIFLORA INCARNATA TOP; STRYCHNOS IGNATII SEED 3; 3; 3; 3; 3; 3 [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 10578-025_483fc475-935a-4d1d-99e7-b5b283f34aa0 10578-025 HUMAN OTC DRUG Homeopathic Acne Formula Arsenicum album, Nitricum acidum, Hepar sulfuris calcarea, Eugenia jambosa, Aurum metallicum, Calcarea suflruica, Solidago virgaurea, Hydrastis canadensis TABLET ORAL 20030101 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARSENIC TRIOXIDE; CALCIUM SULFATE ANHYDROUS; CALCIUM SULFIDE; GOLD; GOLDENSEAL; NITRIC ACID; SOLIDAGO VIRGAUREA FLOWERING TOP; SYZYGIUM JAMBOS SEED 4; 5; 6; 6; 3; 4; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-026_3c0a8311-994b-4e77-a47f-1be1f659c5a3 10578-026 HUMAN OTC DRUG Homeopathic Tension Headache Formula Yellow jasmine, st ignatius bean, carbonate of sodium, poison nut, phosphoric acid TABLET ORAL 20120630 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORIC ACID; SODIUM CARBONATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED 5; 5; 5; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-027_1958acdd-61d7-4040-849f-225303a70bc1 10578-027 HUMAN OTC DRUG Homeopathic Diarrhea Formula Aloe socotrina, Antimonium cruda, Arsenicum album, Belladonna, Bryonia album, Chamomilla, Colocynthis, Podophyllum peltatum, Veratrum album TABLET ORAL 20030101 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ALOE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; MATRICARIA RECUTITA; PODOPHYLLUM; VERATRUM ALBUM ROOT 3; 3; 3; 3; 4; 4; 4; 4; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-028_ab4649f2-fcb1-49b3-8163-943ee481b005 10578-028 HUMAN OTC DRUG Homeopathic Nerve Pain Leopards bane, deadly nightshade, wild hops, yellow jasmine, poison oak TABLET ORAL 20130401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 10578-029_ba42e456-d62e-41dc-a555-747d8b7d3b9f 10578-029 HUMAN OTC DRUG Homeopathic Constipation Relief Oxide of aluminum, wild hops, goldenseal root, magnesium chloride, poison nut TABLET ORAL 20130401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ALUMINUM OXIDE; BRYONIA ALBA ROOT; GOLDENSEAL; MAGNESIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 10578-030_457beec8-26b0-4625-b690-ec1e46047118 10578-030 HUMAN OTC DRUG Homeopathic Motion Sickness Deadly nightshade, indian cockle, ipecac root, poison nut, crude rock-oil TABLET ORAL 20130401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ANAMIRTA COCCULUS SEED; ATROPA BELLADONNA; IPECAC; LIQUID PETROLEUM; STRYCHNOS NUX-VOMICA SEED 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 10578-031_ab73212e-fcb0-42c3-a63d-feb19c92a488 10578-031 HUMAN OTC DRUG Homeopathic Fatigue Formula leopards bane, oat straw, st ignatius bean, phosphoric acid TABLET ORAL 20131001 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; PHOSPHORIC ACID; STRYCHNOS IGNATII SEED 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 10578-032_01710fb2-7d14-457b-9a81-d4c9da51bd29 10578-032 HUMAN OTC DRUG Homeopathic Mental Alertness Formula Agnus castus, Ambra grisea, Nux vomica, Phosphoricum acidum, Zincum metallicum TABLET ORAL 20030101 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens AMBERGRIS; CHASTE TREE; PHOSPHORIC ACID; STRYCHNOS NUX-VOMICA SEED; ZINC 4; 4; 6; 4; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-033_e20548b6-c45b-40ff-9f2d-7b01c6b9ecea 10578-033 HUMAN OTC DRUG Homeopathic Eye Strain silver nitrate, eyebright, carbonate of potassium, garden rue TABLET ORAL 20131001 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens EUPHRASIA STRICTA; POTASSIUM CARBONATE; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 10578-034_688015aa-c274-4bf4-b700-3e68931d87d7 10578-034 HUMAN OTC DRUG Homeopathic Sore Throat Formula purple cone flower, honey bee, deadly nightshade, sundew, wormseed TABLET ORAL 20140401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens APIS MELLIFERA; ARTEMISIA CINA PRE-FLOWERING TOP; ATROPA BELLADONNA; DROSERA ROTUNDIFOLIA; ECHINACEA ANGUSTIFOLIA 8; 8; 8; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 10578-035_62d551fd-f9f3-4b00-a07a-db2556661003 10578-035 HUMAN OTC DRUG Dr. Blue menthol GEL TOPICAL 20030401 OTC MONOGRAPH NOT FINAL part348 Indiana Botanic Gardens MENTHOL 3.89 g/100g 10578-036_c59a2ce6-48cb-4370-bc68-29019fbdefda 10578-036 HUMAN OTC DRUG Homeopathic Bronchitis Formula Asclepias tuberose, Drosera rotundifolia, Hepar sulphuris calcareum, Silicea, Stannum metallicum TABLET ORAL 20100630 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ASCLEPIAS TUBEROSA FLOWERING TOP; CALCIUM SULFIDE; DROSERA ROTUNDIFOLIA; SILICON DIOXIDE; TIN 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 10578-037_b30c203c-0ebf-4157-bc86-f45f33cf871a 10578-037 HUMAN OTC DRUG Homeopathic Yeast Relief Formula Candida albicans, Pulsatilla, Sepia, Thuja occidentalis TABLET ORAL 20090401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CANDIDA ALBICANS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 10578-038_78289343-a6ab-487c-bdfb-86aef8727d43 10578-038 HUMAN OTC DRUG Homeopathic Skin Solutions Formula Nux vomica, Kali arsenicum, Berberis vulgaris, Graphites, Arsenicum album, Hepar sulphuris calcareum, Arsenicum sulphuratum rubrum TABLET ORAL 20030901 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; GRAPHITE; POTASSIUM ARSENITE ANHYDROUS; STRYCHNOS NUX-VOMICA SEED; TETRAARSENIC TETRASULFIDE 12; 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 10578-039_a9b6e512-6179-489c-a067-78ce0f3eaaed 10578-039 HUMAN OTC DRUG Homeopathic Cold and Flu Formula Aconitium napellus, Belladonna, Echinacea angustifolia, Eupatorium perfoliatum, Gelsemium sempervirens, Ferrum phosphoricum, Influenzinum TABLET ORAL 20010101 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ACONITUM NAPELLUS; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; HAEMOPHILUS INFLUENZAE TYPE B 6; 6; 6; 6; 8; 6; 200 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 10578-040_951d1474-346c-48bb-9df9-8a4de19ab47c 10578-040 HUMAN OTC DRUG Painzaway Balm camphor OINTMENT TOPICAL 20011201 OTC MONOGRAPH FINAL part348 Indiana Botanic Gardens CAMPHOR (SYNTHETIC) 4 g/100g 10578-041_c258b145-2b4c-427a-b312-825bb27e459a 10578-041 HUMAN OTC DRUG Homeopathic Lymphatic Clear Formula Calcarea carbonica, Conium maculatum, Hepar sulphuris calcareum, Rhus toxicodendron, Silicea TABLET ORAL 20090401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-042_22db31a6-0655-47c4-821e-185b470630e0 10578-042 HUMAN OTC DRUG Homeopathic Fear and Anxiety Formula Aconite napellus, Argentums nitricum, Gelsemium sempervirens, Hyoscyamus niger, Ignatia amara, Lycopodium clavatum, Phosphorus TABLET ORAL 20100630 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ACONITUM NAPELLUS; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SILVER NITRATE; STRYCHNOS IGNATII SEED 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 10578-043_12ceaacd-96a1-41b6-9b23-a50f614a65d8 10578-043 HUMAN OTC DRUG Homeopathic Yeast Relief Formula Candida albicans, Pulsatilla, Sepia, Thuja occidentalis TABLET ORAL 20090401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CANDIDA ALBICANS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 10578-044_c59ed3ec-f800-49c1-a52d-c794a1705726 10578-044 HUMAN OTC DRUG Homeopathic Trauma Formula Arnica montana, Belladonna, Calendula officinalis, Echinacea angustafolia, Hypericum perforatum, Ruta graveolens, Symphytum officinalis TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARNICA MONTANA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP 30; 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-045_4edf2cbe-07e6-43dd-ba59-0b086af6ff98 10578-045 HUMAN OTC DRUG Homeopathic Facial Redness Formula Belladonna, Calcarea silicate, Lachesis mutus, Phophorus, Nux vomica, Sepia, Sulphuricum acidum TABLET ORAL 20090401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ATROPA BELLADONNA; CALCIUM SILICATE; LACHESIS MUTA VENOM; PHOSPHORUS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SULFURIC ACID 12; 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 10578-046_78652264-87c0-454e-ad13-2c321a04e6c1 10578-046 HUMAN OTC DRUG Homeopathic Periodontal Gum Relief Formula Belladonna, Sodium borate, Hepar sulphuris calcareum, Nitricum acidum TABLET ORAL 20090401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ATROPA BELLADONNA; CALCIUM SULFIDE; NITRIC ACID; SODIUM BORATE 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 10578-047_5e08ba82-4dfa-48c2-8acf-b4bea9da6d90 10578-047 HUMAN OTC DRUG Homeopathic Hangover Formula Antimonium crudum, Bryonia alba, Nux vomica, Ranunculus bulbosus, Zincum metallicum TABLET ORAL 20030101 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ANTIMONY TRISULFIDE; BRYONIA ALBA ROOT; RANUNCULUS BULBOSUS; STRYCHNOS NUX-VOMICA SEED; ZINC 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-048_59de25fc-e58f-47a8-9bba-58af1626b760 10578-048 HUMAN OTC DRUG Homeopathic Ear Ache Formula Aconitum napellus, Belladonna, Capsicum, Chamomile, Ferrum phosphoricum, Kali muriaticum TABLET ORAL 20090401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ACONITUM NAPELLUS; ATROPA BELLADONNA; CAPSICUM; CHAMOMILE; FERRUM PHOSPHORICUM; POTASSIUM CHLORIDE 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-049_294cbe9d-27aa-4f29-80a3-5da3f00cbf7d 10578-049 HUMAN OTC DRUG Homeopathic Shingle Relief Formula arsenicum album, graphite, mercurius solublis, petroleum, rhus toxicodendron TABLET ORAL 20090401 20150331 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARSENIC TRIOXIDE; GRAPHITE; KEROSENE; MERCURIUS SOLUBILIS; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-050_09647e2a-8e8c-4bb6-9890-72bf64bc6c7b 10578-050 HUMAN OTC DRUG Homeopathic Thyroid Formula Fucus vesiculosus, Lycopodium clavatum, Natrum muriaticum, Spongia tosta, Thyroidinum TABLET ORAL 20100630 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens FUCUS VESICULOSUS; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID 30; 30; 30; 30; 7 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-051_e1d59cb3-2489-4299-b1e9-57f46230feca 10578-051 HUMAN OTC DRUG Homeopathic Muscle Pain and Stiffness Formula Arnica montana, Badiaga, Bellis perennis, Bryonia, Causticum, Rhus toxicodendron TABLET ORAL 20100630 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CAUSTICUM; SPONGILLA LACUSTRIS; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-052_aacb3393-ee2d-475c-925f-79a9fa2c015e 10578-052 HUMAN OTC DRUG Homeopathic Cold and Canker Sore Formula Antimonum crudum, Apis mellifica, Cuprum metallicum, Euphorbia lathyris, Rhus toxicodendron TABLET ORAL 20100707 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ANTIMONY TRISULFIDE; APIS MELLIFERA; COPPER; EUPHORBIA LATHYRIS; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 10578-053_f09d90bd-3447-4db8-8fa0-d6ddd74375f0 10578-053 HUMAN OTC DRUG Homeopathic Perspiration Formula Tartaremetic, carbonate lime, vegetable charcoal, pure flint, sulphur TABLET ORAL 20140401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ACTIVATED CHARCOAL; ANTIMONY POTASSIUM TARTRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; SULFUR 8; 8; 8; 8; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 10578-054_3e840f9d-16f7-4a50-8f33-1724550faaf6 10578-054 HUMAN OTC DRUG Homeopathic Womens Libido chastetree, oatstraw, potassium hydrate, common salt, cuttle fish TABLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens AVENA SATIVA FLOWERING TOP; CAUSTICUM; CHASTE TREE; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 10578-055_a2203138-3770-4445-9b4d-ca444aa75897 10578-055 HUMAN OTC DRUG Neuro Support Plus Foot Balm camphor OINTMENT TOPICAL 20140626 OTC MONOGRAPH NOT FINAL part348 Indiana Botanic Gardens CAMPHOR (SYNTHETIC) 4 g/100g 10579-252_08ade9cd-9437-479e-957b-a9045eb040d6 10579-252 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20111028 OTC MONOGRAPH NOT FINAL part333A HAIYANG XINYI Towelette CO., LTD. ISOPROPYL ALCOHOL .7 mL/mL 10586-9102_f6ac75f3-5ba0-44cf-bcf3-137eebb04f11 10586-9102 HUMAN OTC DRUG Instant Hand Sanitizer - Vanilla Scented ALCOHOL LIQUID TOPICAL 20111102 OTC MONOGRAPH FINAL part333E Core Brands, Inc. ALCOHOL 62 mL/100mL 10586-9103_a0f75b3b-81b1-425b-b65e-bf0b3de6566c 10586-9103 HUMAN OTC DRUG Instant Hand Sanitizer - Original ALCOHOL LIQUID TOPICAL 20111102 OTC MONOGRAPH FINAL part333E Core Brands, Inc. ALCOHOL 62 mL/100mL 10586-9104_ada3b9c2-3bb4-423a-9ead-f906d712a05f 10586-9104 HUMAN OTC DRUG Instant Hand Sanitizer - Vanilla Scented ALCOHOL LIQUID TOPICAL 20111102 OTC MONOGRAPH FINAL part333E Core Brands, Inc. ALCOHOL 62 mL/100mL 10586-9105_003f51a6-9222-457f-b419-420026a60144 10586-9105 HUMAN OTC DRUG Instant Hand Sanitizer - Strawberry Scented ALCOHOL LIQUID TOPICAL 20111102 OTC MONOGRAPH FINAL part333E Core Brands, Inc. ALCOHOL 62 mL/100mL 10586-9106_f3fbfe81-a177-463c-bcff-169aff11bfa4 10586-9106 HUMAN OTC DRUG Instant Hand Sanitizer - Original ALCOHOL LIQUID TOPICAL 20111102 OTC MONOGRAPH FINAL part333E Core Brands, Inc. ALCOHOL 62 mL/100mL 10590-0001_86d5624a-5147-48b8-b59f-775591bd01ad 10590-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19440101 UNAPPROVED MEDICAL GAS Jackson Welding Supply Company, Inc OXYGEN 99 L/100L 10596-132_7356c1f6-c02f-411d-8b3d-89b15d20da62 10596-132 HUMAN OTC DRUG Biore Blemish Treating Astringent SALICYLIC ACID LIQUID TOPICAL 20111109 OTC MONOGRAPH FINAL part333D Kao Brands Company SALICYLIC ACID 4.56 g/236mL 10596-153_e90bdbc1-60ea-4ab1-8146-49a6be84eff4 10596-153 HUMAN OTC DRUG Biore Warming Anti-Blackhead Cleanser SALICYLIC ACID LIQUID TOPICAL 20111228 OTC MONOGRAPH FINAL part333D Kao Brands Company SALICYLIC ACID 2.54 g/127g 10596-159_e568cc54-5ece-4891-bd89-3802007ace76 10596-159 HUMAN OTC DRUG Biore Blemish Fighting Ice Cleanser SALICYLIC ACID LIQUID TOPICAL 20111228 OTC MONOGRAPH FINAL part333D Kao Brands Company SALICYLIC ACID 4.3 g/200mL 10596-161_33546597-7c97-4268-b78e-f8ce19cb1d2b 10596-161 HUMAN OTC DRUG Biore Pore Unclogging Scrub SALICYLIC ACID LIQUID TOPICAL 20111228 OTC MONOGRAPH FINAL part333D Kao Brands Company SALICYLIC ACID 2.8 g/141g 10596-309_c195553b-bdef-4d89-8dca-564c04da4c27 10596-309 HUMAN OTC DRUG Ban Invisible Solid Antiperspirant Deodorant Vanilla Softness ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20111229 OTC MONOGRAPH FINAL part350 Kao Brands Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g 10596-330_5f487d03-a0cd-47d7-9500-d652ece529d8 10596-330 HUMAN OTC DRUG Ban Invisible Solid Antiperspirant Deodorant Paradise Winds ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20111229 OTC MONOGRAPH FINAL part350 Kao Brands Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g 10596-331_7409d650-fc47-4fb9-9c85-1f2bbb06727a 10596-331 HUMAN OTC DRUG Ban Invisible Solid Antiperspirant Deodorant Powder Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20111229 OTC MONOGRAPH FINAL part350 Kao Brands Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g 10596-332_a5123629-d8c5-4349-b3c6-22f330a4ec70 10596-332 HUMAN OTC DRUG Ban Invisible Solid Antiperspirant Deodorant Island Falls ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20111229 OTC MONOGRAPH FINAL part350 Kao Brands Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g 10596-333_6d870c28-7b98-4a5e-b358-df8efdc28f8e 10596-333 HUMAN OTC DRUG Ban Invisible Solid Antiperspirant Deodorant Shower Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20111229 OTC MONOGRAPH FINAL part350 Kao Brands Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g 10596-334_b0a97448-db53-480f-92f1-cc2b7b037003 10596-334 HUMAN OTC DRUG Ban Invisible Solid Antiperspirant Deodorant Sweet Simplicity ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20111229 OTC MONOGRAPH FINAL part350 Kao Brands Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g 10596-335_fa83df73-a7c2-4d31-81fb-2c6d696ae2be 10596-335 HUMAN OTC DRUG Ban Invisible Solid Antiperspirant Deodorant Unscented ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20111229 OTC MONOGRAPH FINAL part350 Kao Brands Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g 10596-336_cd2f8d19-1aa4-4347-9dbf-9a0f4eabd19d 10596-336 HUMAN OTC DRUG Ban Roll-On Antiperspirant Deodorant Regular Aluminum Chlorohydrate LIQUID TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Kao Brands Company ALUMINUM CHLOROHYDRATE 20 g/103mL 10596-337_2f8a4544-2b67-4329-840b-49fb46729e36 10596-337 HUMAN OTC DRUG Ban Roll-On Antiperspirant Deodorant Powder Fresh Aluminum Chlorohydrate LIQUID TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Kao Brands Company ALUMINUM CHLOROHYDRATE 20 g/103mL 10596-338_2dee962c-e6e8-4d0c-a64a-b00fb793f79f 10596-338 HUMAN OTC DRUG Ban Roll-On Antiperspirant Deodorant Unscented Aluminum Chlorohydrate LIQUID TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Kao Brands Company ALUMINUM CHLOROHYDRATE 20 g/103mL 10596-339_a099edae-28a1-4414-8fe0-94b0fc20ae5c 10596-339 HUMAN OTC DRUG Ban Roll-On Antiperspirant Deodorant Satin Breeze Aluminum Chlorohydrate LIQUID TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Kao Brands Company ALUMINUM CHLOROHYDRATE 20 g/103mL 10596-340_f3274389-5b67-464c-b2ec-b80729d634a8 10596-340 HUMAN OTC DRUG Ban Roll-On Antiperspirant Deodorant Fresh Cotton Aluminum Chlorohydrate LIQUID TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Kao Brands Company ALUMINUM CHLOROHYDRATE 20 g/103mL 10596-341_ed2a309c-bcbe-45cc-a634-67fb55222517 10596-341 HUMAN OTC DRUG Ban Clear Antiperspirant Deodorant Cool Sport ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY GEL TOPICAL 20111229 OTC MONOGRAPH FINAL part350 Kao Brands Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 10.08 g/63g 10596-342_334eb846-6539-4ec5-9c01-54134f417c29 10596-342 HUMAN OTC DRUG Ban Clear Antiperspirant Deodorant Powder Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY GEL TOPICAL 20111229 OTC MONOGRAPH FINAL part350 Kao Brands Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 10.08 g/63g 10596-400_1dbe9a90-0fac-4e25-be26-acbd913969e1 10596-400 HUMAN OTC DRUG Ban Roll-On Antiperspirant Deodorant Simple Clean Aluminum Chlorohydrate LIQUID TOPICAL 20111108 OTC MONOGRAPH FINAL part350 Kao Brands Company ALUMINUM CHLOROHYDRATE 20 g/103mL 10596-703_dbf8a930-79f5-4cd5-b887-a2fa7d9c766b 10596-703 HUMAN OTC DRUG Jergens Natural Glow Octinoxate Oxybenzone LOTION TOPICAL 20111228 OTC MONOGRAPH NOT FINAL part352 Kao Brands Company OCTINOXATE; OXYBENZONE 3.58; 1.19 g/59mL; g/59mL 10596-704_c6e8e6a9-690b-436a-b594-774397940f26 10596-704 HUMAN OTC DRUG Jergens Natural Glow Octinoxate Oxybenzone LOTION TOPICAL 20111228 OTC MONOGRAPH NOT FINAL part352 Kao Brands Company OCTINOXATE; OXYBENZONE 3.58; 1.19 g/59mL; g/59mL 10597-559_5108bdca-1454-4353-b55f-e31da8ed4f4f 10597-559 HUMAN OTC DRUG Fasprin Aspirin TABLET, ORALLY DISINTEGRATING ORAL 20060920 OTC MONOGRAPH FINAL part343 Nobel Laboratories, LLC ASPIRIN 81 mg/1 10631-091_56465446-7f78-4ad1-acb3-08a4d60e5715 10631-091 HUMAN PRESCRIPTION DRUG Eurax Lotion and Cream Eurax CREAM TOPICAL 20081215 NDA NDA006927 Ranbaxy Laboratories Inc. CROTAMITON 100 mg/g 10631-092_56465446-7f78-4ad1-acb3-08a4d60e5715 10631-092 HUMAN PRESCRIPTION DRUG Eurax Lotion and Cream Eurax LOTION TOPICAL 20081113 NDA NDA009112 Ranbaxy Laboratories Inc. CROTAMITON 100 mg/g 10631-093_1c36590f-1a3b-47de-9530-6f91668c42e7 10631-093 HUMAN PRESCRIPTION DRUG Kenalog Triamcinolone Acetonide AEROSOL, SPRAY TOPICAL 20090519 NDA NDA012104 Ranbaxy Laboratories Inc. TRIAMCINOLONE ACETONIDE .147 mg/g 10631-094_1aaf2fde-c032-43fb-a974-09fcc4fd35d8 10631-094 HUMAN PRESCRIPTION DRUG Halog Halcinonide Cream CREAM TOPICAL 20090210 NDA NDA017556 Ranbaxy Laboratories Inc HALCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10631-096_ba27e6b1-2d23-46c5-9305-33b0462ce21d 10631-096 HUMAN PRESCRIPTION DRUG HALOG HALCINONIDE OINTMENT TOPICAL 20090519 NDA NDA017824 Ranbaxy Laboratories Inc. HALCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10631-098_97c531eb-d922-445b-894b-74d644d4f0aa 10631-098 HUMAN PRESCRIPTION DRUG Lac-Hydrin ammonium lactate LOTION TOPICAL 20080815 NDA NDA019155 Ranbaxy Laboratories Inc. AMMONIUM LACTATE 120 mg/g 10631-099_807054c6-2dae-4cc2-b790-674ab66cf79b 10631-099 HUMAN PRESCRIPTION DRUG Lac Hydrin Cream ammonium lactate CREAM TOPICAL 20090316 NDA NDA020508 Ranbaxy Laboratories Inc. AMMONIUM LACTATE 120 mg/g 10631-100_8ca12146-4320-4f26-89a9-8d81fcfca31a 10631-100 HUMAN PRESCRIPTION DRUG Exelderm sulconazole nitrate SOLUTION TOPICAL 20090408 NDA NDA018738 Ranbaxy Laboratories Inc. SULCONAZOLE NITRATE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 10631-101_eb5e8745-e610-432d-9d7f-44ea0ce77a00 10631-101 HUMAN PRESCRIPTION DRUG Exelderm sulconazole nitrate CREAM TOPICAL 20100201 NDA NDA018737 Ranbaxy Laboratories Inc. SULCONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 10631-102_cd9a3fc1-f9e4-4ab7-9c75-50ab9c65e270 10631-102 HUMAN PRESCRIPTION DRUG Ultravate halobetasol propionate OINTMENT TOPICAL 20090220 NDA NDA019968 Ranbaxy Laboratories Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10631-103_cd9a3fc1-f9e4-4ab7-9c75-50ab9c65e270 10631-103 HUMAN PRESCRIPTION DRUG Ultravate halobetasol propionate CREAM TOPICAL 20090316 NDA NDA019967 Ranbaxy Laboratories Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10631-105_baabd35a-322c-4245-9a1b-c86c83008047 10631-105 HUMAN PRESCRIPTION DRUG Westcort Hydrocortisone valerate OINTMENT TOPICAL 20081006 NDA NDA018726 Ranbaxy Laboratories Inc. HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10631-110_736c1976-7448-4d04-8ca7-9455e4db96e8 10631-110 HUMAN PRESCRIPTION DRUG Ultravate PAC halobetasol propionate OINTMENT TOPICAL 20080513 NDA NDA019968 Ranbaxy Laboratories Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10631-113_54c3cb61-1c22-414a-9388-51fbec1dd826 10631-113 HUMAN PRESCRIPTION DRUG Ultravate PAC-Cream halobetasol propionate CREAM TOPICAL 20100210 NDA NDA019967 Ranbaxy Laboratories Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10631-115_aaa8a771-1687-448a-83cb-80ad3fde51c7 10631-115 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20120608 NDA NDA021951 Ranbaxy Laboratories Inc. ISOTRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 10631-116_aaa8a771-1687-448a-83cb-80ad3fde51c7 10631-116 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20120608 NDA NDA021951 Ranbaxy Laboratories Inc. ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 10631-117_aaa8a771-1687-448a-83cb-80ad3fde51c7 10631-117 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20120608 NDA NDA021951 Ranbaxy Laboratories Inc. ISOTRETINOIN 30 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 10631-118_aaa8a771-1687-448a-83cb-80ad3fde51c7 10631-118 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20120608 NDA NDA021951 Ranbaxy Laboratories Inc. ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 10631-119_94656dc4-95ad-4d89-9acd-f7a15854127e 10631-119 HUMAN PRESCRIPTION DRUG Ultravate X Halobetasol Propionate KIT 20120701 NDA NDA019968 Ranbaxy Laboratories Inc. 10631-121_346cc153-69ac-4e6f-802c-3ba322347598 10631-121 HUMAN PRESCRIPTION DRUG Ultravate X Halobetasol Propionate KIT 20120709 NDA NDA019967 Ranbaxy Laboratories Inc. 10631-133_aaa8a771-1687-448a-83cb-80ad3fde51c7 10631-133 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20120608 NDA NDA021951 Ranbaxy Laboratories Inc. ISOTRETINOIN 25 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 10631-134_aaa8a771-1687-448a-83cb-80ad3fde51c7 10631-134 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20120608 NDA NDA021951 Ranbaxy Laboratories Inc. ISOTRETINOIN 35 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 10631-206_fbd30beb-e4fa-4e79-a599-dec3c9a68afb 10631-206 HUMAN PRESCRIPTION DRUG Riomet Metformin Hydrochloride SOLUTION ORAL 20040104 NDA NDA021591 Ranbaxy Laboratories Inc. METFORMIN HYDROCHLORIDE 500 mg/5mL Biguanide [EPC],Biguanides [Chemical/Ingredient] 10631-238_fbd30beb-e4fa-4e79-a599-dec3c9a68afb 10631-238 HUMAN PRESCRIPTION DRUG Riomet Metformin Hydrochloride SOLUTION ORAL 20140915 NDA NDA021591 Ranbaxy Laboratories Inc. METFORMIN HYDROCHLORIDE 500 mg/5mL Biguanide [EPC],Biguanides [Chemical/Ingredient] 10631-278_0e775c30-7294-4e99-bcc5-3b3b01a62fc5 10631-278 HUMAN OTC DRUG Desquam-X Wash benzoyl peroxide SOLUTION TOPICAL 20110426 OTC MONOGRAPH FINAL part333D Ranbaxy Laboratories Inc. BENZOYL PEROXIDE 5 mg/g 10631-279_0e775c30-7294-4e99-bcc5-3b3b01a62fc5 10631-279 HUMAN OTC DRUG Desquam-X Wash benzoyl peroxide SOLUTION TOPICAL 20110426 OTC MONOGRAPH FINAL part333D Ranbaxy Laboratories Inc. BENZOYL PEROXIDE 10 mg/g 10631-284_aaa9dea2-e064-494b-8a69-de5d520594a8 10631-284 HUMAN PRESCRIPTION DRUG Desquam-X wash benzoyl peroxide SOLUTION TOPICAL 20080827 UNAPPROVED DRUG OTHER Ranbaxy Laboratories Inc. BENZOYL PEROXIDE 5 mg/mL 10631-285_aaa9dea2-e064-494b-8a69-de5d520594a8 10631-285 HUMAN PRESCRIPTION DRUG Desquam-X wash benzoyl peroxide SOLUTION TOPICAL 20080502 UNAPPROVED DRUG OTHER Ranbaxy Laboratories Inc. BENZOYL PEROXIDE 10 mg/mL 10631-330_6e7d2a2f-e4b2-4d12-8d5d-e1c3a832b35c 10631-330 HUMAN PRESCRIPTION DRUG Ximino minocycline hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120901 NDA NDA201922 Ranbaxy Laboratories Inc. MINOCYCLINE HYDROCHLORIDE 45 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 10631-331_6e7d2a2f-e4b2-4d12-8d5d-e1c3a832b35c 10631-331 HUMAN PRESCRIPTION DRUG Ximino minocycline hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120901 NDA NDA201922 Ranbaxy Laboratories Inc. MINOCYCLINE HYDROCHLORIDE 90 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 10631-332_6e7d2a2f-e4b2-4d12-8d5d-e1c3a832b35c 10631-332 HUMAN PRESCRIPTION DRUG Ximino minocycline hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120901 NDA NDA201922 Ranbaxy Laboratories Inc. MINOCYCLINE HYDROCHLORIDE 135 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 10631-407_cf451708-70ab-47f1-9b44-bf0cc602e261 10631-407 HUMAN PRESCRIPTION DRUG Proctosol-HC Hydrocortisone CREAM TOPICAL 20050428 ANDA ANDA088799 Ranbaxy Laboratories Inc HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10641-001_825a16a8-489c-4101-b99c-0f9535a51718 10641-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19530908 UNAPPROVED MEDICAL GAS Lake Welding Supply Company OXYGEN 995 mL/L 10655-1944_78e5be58-ba81-429a-914c-882d04c4e67f 10655-1944 HUMAN OTC DRUG Nasosol Saline SODIUM CHLORIDE SPRAY NASAL 20110111 UNAPPROVED DRUG OTHER Benton Therapeutics, Inc. SODIUM CHLORIDE 3 mL/100mL 10671-010_68377a13-91ca-43a2-8076-075f5759cad5 10671-010 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205827 Air Liquide America L.P. OXYGEN 99 L/100L 10671-011_88eec941-277a-4f7f-a7af-149e8d34441f 10671-011 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205827 Air Liquide America L.P. OXYGEN 99 L/100L 10671-013_9f31c74c-73b0-4ca5-a2d9-23f9f4bfbad7 10671-013 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205827 Air Liquide America L.P. OXYGEN 99 L/100L 10671-020_53cc9f2c-4a98-4bd4-af80-d7bfc63398fc 10671-020 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205829 Air Liquide America L.P. NITROGEN 99 L/100L 10671-021_53cc9f2c-4a98-4bd4-af80-d7bfc63398fc 10671-021 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205829 Air Liquide America L.P. NITROGEN 99 L/100L 10671-022_53cc9f2c-4a98-4bd4-af80-d7bfc63398fc 10671-022 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205829 Air Liquide America L.P. NITROGEN 99 L/100L 10671-023_53cc9f2c-4a98-4bd4-af80-d7bfc63398fc 10671-023 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205829 Air Liquide America L.P. NITROGEN 99 L/100L 10671-100_4e255a48-1d39-477e-b24c-f4d814c83cb7 10671-100 HUMAN PRESCRIPTION DRUG EZ-OX OXYGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205827 Air Liquide America L.P. OXYGEN 99 L/100L 10671-101_5e617966-03e2-48f3-b2f9-b5a48087dd54 10671-101 HUMAN PRESCRIPTION DRUG EZ-OX Plus EZ-OX Plus GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205827 Air Liquide America L.P. OXYGEN 99 L/100L 10675-002_3f08b518-8975-4eeb-aad6-49c0948fff89 10675-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS America's Healthcare At Home, Inc. OXYGEN 99 L/100L 10678-001_87f75b7d-93c7-4f9d-b04b-12505e417a6f 10678-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. OXYGEN 992 mL/L 10678-002_110133ca-2e25-4873-a5fe-beaa53a0d166 10678-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. NITROGEN 992 mL/L 10678-003_a417c555-9f9a-4ba5-8b0d-87c680fc41e2 10678-003 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. CARBON DIOXIDE 992 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 10678-004_30a834fa-7c4e-4b5c-9035-523b42035056 10678-004 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. HELIUM 992 mL/L 10678-005_04f969ab-32bb-4599-b58d-a03c232f2a89 10678-005 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. AIR 1000 mL/L 10678-006_9e4d7ac2-5a05-47ee-9349-87431e028eeb 10678-006 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. NITROUS OXIDE 992 mL/L 10678-007_1908fe5a-36f1-4ce3-a458-90154a81025c 10678-007 HUMAN PRESCRIPTION DRUG Helium Oxygen Mix Helium Oxygen Mix GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. HELIUM; OXYGEN 600; 400 mL/L; mL/L 10678-008_27ec7dff-f916-46fe-97bd-76e007305446 10678-008 HUMAN PRESCRIPTION DRUG Oxygen Carbon Dioxide Mix Oxygen Carbon Dioxide Mix GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. CARBON DIOXIDE; OXYGEN 50; 950 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 10678-010_e8e2d396-66f6-4ff2-8601-733753b23a42 10678-010 HUMAN PRESCRIPTION DRUG Helium Oxygen Mix 70/30 Helium Oxygen Mix 70/30 GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. HELIUM; OXYGEN 700; 300 mL/L; mL/L 10678-011_1155add9-7528-4250-9580-11c42d0c7a2e 10678-011 HUMAN PRESCRIPTION DRUG Helium Oxygen Mix 80/20 Helium Oxygen Mix 80/20 GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. HELIUM; OXYGEN 800; 200 mL/L; mL/L 10685-511_e658dbfd-c124-43ce-a069-284ab3d9faaa 10685-511 HUMAN OTC DRUG PC511 ANTIMICROBIAL CHLOROXYLENOL SOAP TOPICAL 20131016 OTC MONOGRAPH NOT FINAL part333E CARROLL COMPANY CHLOROXYLENOL 3 g/1000mL 10685-520_cba43806-eed8-4048-8b03-e7245aa19297 10685-520 HUMAN OTC DRUG Clean N Fresh Instant Hand Sanitizer Alcohol SOAP TOPICAL 20001001 OTC MONOGRAPH NOT FINAL part333E Carroll Company ALCOHOL .62 mL/mL 10685-529_591f5635-c590-4ccd-9549-232be18b4ab1 10685-529 HUMAN OTC DRUG PC529 ULTREX CHLOROXYLENOL SOAP TOPICAL 20140121 OTC MONOGRAPH NOT FINAL part333E CARROLL COMPANY CHLOROXYLENOL 2.5 g/1000mL 10685-537_b7ea7928-b80b-4c8b-b9b1-fc8e37d5850a 10685-537 HUMAN OTC DRUG PC537 E-2 BRUTE CHLOROXYLENOL SOAP TOPICAL 20131016 OTC MONOGRAPH NOT FINAL part333E CARROLL COMPANY CHLOROXYLENOL 25 g/1000mL 10685-557_c1ae1b21-7bb6-41c7-a4af-2a0f4fb7fc21 10685-557 HUMAN OTC DRUG PC557 PALPON CHLOROXYLENOL SOAP TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E CARROLL COMPANY CHLOROXYLENOL 2.5 g/1000mL 10685-681_2e88474f-decc-4b42-91d7-135389af8f87 10685-681 HUMAN OTC DRUG Carroll Ultrex Antimicrobial Wipes Benzalkonium Chloride CLOTH TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part333E Carroll Company BENZALKONIUM CHLORIDE .01417 g/1 10685-682_43f1d624-39ff-4170-ada1-9a45658ecee0 10685-682 HUMAN OTC DRUG Carroll Hand Sanitizer Wipes with Aloe Benzalkonium Chloride CLOTH TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part333E Carroll Company BENZALKONIUM CHLORIDE .0067275 g/1 10685-978_ad232487-f335-41ad-88dc-4ccbeccdf7cf 10685-978 HUMAN OTC DRUG NAMICO ANTISEPTIC HAND CLEANER 557 CHLOROXYLENOL SOAP TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E CARROLL COMPANY CHLOROXYLENOL 2.5 g/1000mL 10690-001_a825b982-db20-4b44-97e0-ddc6fd4b6e8f 10690-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19780101 UNAPPROVED MEDICAL GAS Depke Welding Supplies, Inc. OXYGEN 995 mL/L 10690-002_7d0811af-4a56-413d-a195-1aae8d8e5e45 10690-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19870101 UNAPPROVED MEDICAL GAS Depke Welding Supplies, Inc. NITROGEN 990 mL/L 10698-0001_2214e8be-76fa-4d86-a0c2-85cd5cf337bc 10698-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19480101 UNAPPROVED MEDICAL GAS Mabscott Supply Company OXYGEN 99 L/100L 10702-002_c99c109f-5ebf-483c-8819-45d2f55f96c6 10702-002 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET ORAL 20140709 ANDA ANDA040712 KVK-Tech, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 10702-003_c99c109f-5ebf-483c-8819-45d2f55f96c6 10702-003 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET ORAL 20140709 ANDA ANDA040712 KVK-Tech, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 10702-004_c99c109f-5ebf-483c-8819-45d2f55f96c6 10702-004 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET ORAL 20140709 ANDA ANDA040713 KVK-Tech, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 10702-005_44db7d0c-7cc0-45ab-8723-ddedb94ea378 10702-005 HUMAN OTC DRUG Dexbrompherniramine Maleate and Pseudoephedrine Sulfate 6mg/120mg Dexbrompherniramine Maleate and Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20130227 ANDA ANDA078648 KVK-TECH, INC. DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE 6; 120 mg/1; mg/1 10702-006_6afbcc98-7c48-4bf8-93da-949cd91dca7d 10702-006 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140731 ANDA ANDA078048 KVK-TECH, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 10702-007_6afbcc98-7c48-4bf8-93da-949cd91dca7d 10702-007 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140731 ANDA ANDA078048 KVK-TECH, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 10702-008_2df71fa4-24cd-4204-918a-ba66e01ae944 10702-008 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20131018 ANDA ANDA091393 KVK-TECH,INC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10702-009_2df71fa4-24cd-4204-918a-ba66e01ae944 10702-009 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20131018 ANDA ANDA091393 KVK-TECH,INC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10702-010_ac7fef22-dc8f-4711-8b96-567aa78ffa92 10702-010 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040786 KVK-Tech, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 10702-011_ac7fef22-dc8f-4711-8b96-567aa78ffa92 10702-011 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040787 KVK-Tech, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 10702-012_ac7fef22-dc8f-4711-8b96-567aa78ffa92 10702-012 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040788 KVK-Tech, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 10702-013_04c19aa8-396c-4621-8a60-778684781cc5 10702-013 HUMAN PRESCRIPTION DRUG BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET, COATED ORAL 20111102 ANDA ANDA078962 KVK-TECH, INC. BETAXOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 10702-014_04c19aa8-396c-4621-8a60-778684781cc5 10702-014 HUMAN PRESCRIPTION DRUG BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET, COATED ORAL 20111102 ANDA ANDA078962 KVK-TECH, INC. BETAXOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 10702-016_12229472-31bb-4d55-b9b6-6c2b6c00cf79 10702-016 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20120727 ANDA ANDA079175 KVK-Tech, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10702-017_17f91999-b3ac-4707-98d5-12052d467f94 10702-017 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100615 ANDA ANDA040829 KVK-Tech, Inc. CHLORPHENIRAMINE MALEATE 12 mg/1 10702-018_2df71fa4-24cd-4204-918a-ba66e01ae944 10702-018 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20131018 ANDA ANDA091393 KVK-TECH,INC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10702-025_f214f8ae-e8f7-49fa-b7c8-6a37141dee35 10702-025 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120815 ANDA ANDA040876 KVK-TECH, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 10702-026_91cf84db-d73c-4764-8364-3cc1568caa18 10702-026 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 KVK-Tech, Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 10702-027_91cf84db-d73c-4764-8364-3cc1568caa18 10702-027 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 KVK-Tech, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 10702-028_91cf84db-d73c-4764-8364-3cc1568caa18 10702-028 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040875 KVK-Tech, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 10702-029_f214f8ae-e8f7-49fa-b7c8-6a37141dee35 10702-029 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120815 ANDA ANDA040887 KVK-TECH, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 10702-036_27b52dbc-a95f-46d9-8ab1-791f6e243468 10702-036 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate Sodium Polystyrene Sulfonate POWDER ORAL; RECTAL 20120725 ANDA ANDA040905 KVK-Tech, Inc. SODIUM POLYSTYRENE SULFONATE 1 g/g 10702-040_c02935e8-61ee-4df7-95a6-ac2375082383 10702-040 HUMAN PRESCRIPTION DRUG BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET ORAL 20100721 ANDA ANDA090968 KVK-TECH, INC BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 10702-044_36512f30-4559-4625-9c08-5a06aa544782 10702-044 HUMAN PRESCRIPTION DRUG DIETHYLPROPION HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE TABLET ORAL 20101227 ANDA ANDA201212 KVK-TECH, INC DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 10702-045_3e594fab-cbe0-4135-a5e6-fe48fa6bc4fe 10702-045 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 KVK-TECH, INC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 10702-052_9b85615f-7877-4b04-b376-d15d8e5feff2 10702-052 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride hydroxyzine hydrochloride SOLUTION ORAL 20080926 ANDA ANDA040010 KVK-Tech, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 10702-056_2df71fa4-24cd-4204-918a-ba66e01ae944 10702-056 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20131018 ANDA ANDA091393 KVK-TECH,INC OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10702-057_2df71fa4-24cd-4204-918a-ba66e01ae944 10702-057 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20131018 ANDA ANDA091393 KVK-TECH,INC OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 10702-070_3034045e-7818-4c95-8b52-d10bf21af88e 10702-070 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20130211 ANDA ANDA203601 KVK-Tech, Inc. OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 10702-071_3034045e-7818-4c95-8b52-d10bf21af88e 10702-071 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20130211 ANDA ANDA203601 KVK-Tech, Inc. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 10702-077_3e594fab-cbe0-4135-a5e6-fe48fa6bc4fe 10702-077 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 KVK-TECH, INC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 10702-078_3e594fab-cbe0-4135-a5e6-fe48fa6bc4fe 10702-078 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 KVK-TECH, INC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 10705-077_bf97908c-8a54-4edd-82e6-7ff2eef48ef0 10705-077 HUMAN OTC DRUG Mandelay Male Genital Desensitizer Benzocaine GEL TOPICAL 19951031 OTC MONOGRAPH FINAL part348 Majestic Drug Co., INC. BENZOCAINE 2.13 g/28.35g 10725-0001_6ce0db86-2999-4d52-be7e-1578b481794e 10725-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19730101 UNAPPROVED MEDICAL GAS Red River Welding Supply Co. dba McGinnis Welding Supply Co OXYGEN 99 L/100L 10733-130_f025f863-bb6f-49e8-b6d9-5702e933aa29 10733-130 HUMAN PRESCRIPTION DRUG FluoriSHIELD Sodium Fluoride GEL DENTAL 20091129 UNAPPROVED DRUG OTHER Medical Products Laboratories, Inc. SODIUM FLUORIDE 11 mg/g 10733-357_629c5273-6b0c-406f-bee8-3a6c485deabb 10733-357 HUMAN PRESCRIPTION DRUG kolorz Sodium Fluoride AEROSOL, FOAM DENTAL 20070101 UNAPPROVED DRUG OTHER Medical Products Laboratories, Inc. SODIUM FLUORIDE 27.2 mg/g 10733-372_7d3a5132-76a6-4e74-bc5a-19607cecb30f 10733-372 HUMAN PRESCRIPTION DRUG kolorz Sodium Fluoride AEROSOL, FOAM DENTAL 20070101 UNAPPROVED DRUG OTHER Medical Products Laboratories, Inc. SODIUM FLUORIDE 27.2 mg/g 10733-395_b7d0782a-07e2-47df-b118-57902a1eb724 10733-395 HUMAN PRESCRIPTION DRUG kolorz Sodium Fluoride AEROSOL, FOAM DENTAL 20070101 UNAPPROVED DRUG OTHER Medical Products Laboratories, Inc. SODIUM FLUORIDE 27.2 mg/g 10733-412_13a2ec4c-8915-4875-a1ef-24395b846eda 10733-412 HUMAN PRESCRIPTION DRUG lumicain Aluminium Chloride Hexahydrate SOLUTION TOPICAL 20100929 UNAPPROVED DRUG OTHER Medical Products Laboratories, Inc. ALUMINUM CHLORIDE 250 mg/g 10736-001_911a4844-03d5-4e44-9dc7-ff3c4a25c4dc 10736-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20120529 UNAPPROVED MEDICAL GAS Medical-Technical Gases, Inc. OXYGEN 99 L/100L 10736-002_024d0394-d48a-4b30-a234-7ab72da78c31 10736-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20120529 UNAPPROVED MEDICAL GAS Medical-Technical Gases, Inc. NITROGEN 99 L/100L 10736-009_2ef85bec-351c-4043-939b-ce6cf843e9e7 10736-009 HUMAN PRESCRIPTION DRUG COMPRESSED GAS, OXIDIZING, N.O.S. OXYGEN, CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 20120529 UNAPPROVED MEDICAL GAS Medical-Technical Gases, Inc. CARBON DIOXIDE; OXYGEN 5; 95 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 10736-010_3938863f-60c6-498a-82cf-7b786ee1ef81 10736-010 HUMAN PRESCRIPTION DRUG COMPRESSED GAS, OXIDIZING, N.O.S. OXYGEN, CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 20120529 UNAPPROVED MEDICAL GAS Medical-Technical Gases, Inc. CARBON DIOXIDE; OXYGEN 5; 95 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 10736-011_1ffa362c-7cf7-4c60-9ee0-43de0fa84b42 10736-011 HUMAN PRESCRIPTION DRUG COMPRESSED GAS N.O.S. OXYGEN, NITROGEN, CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 20120529 UNAPPROVED MEDICAL GAS Medical-Technical Gases, Inc. CARBON DIOXIDE; NITROGEN; OXYGEN 5; 75.05; 19.95 mL/L; mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 10736-012_8bd8ffb9-e67b-4c0e-845f-5a9df5f799e2 10736-012 HUMAN PRESCRIPTION DRUG Carbon Dioxide Air Mix Carbon Dioxide Air Mix GAS RESPIRATORY (INHALATION) 20120529 UNAPPROVED MEDICAL GAS Medical-Technical Gases, Inc. AIR; CARBON DIOXIDE 990; 10 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 10736-013_72aa1b23-a1e1-43e9-b02b-0a3d99221366 10736-013 HUMAN PRESCRIPTION DRUG Helium Oxygen Mixture Helium Oxygen mixture GAS RESPIRATORY (INHALATION) 20140501 UNAPPROVED MEDICAL GAS Medical-technical Gases, Inc. HELIUM; OXYGEN 800; 200 mL/L; mL/L 10736-014_1a42ac0a-0fea-41ed-8289-0affef995c90 10736-014 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 19630101 UNAPPROVED MEDICAL GAS Medical-Technical Gases, Inc. CARBON DIOXIDE 995 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 10736-016_d3dee2f2-6bc1-4622-a0c3-7709f7c77f91 10736-016 HUMAN PRESCRIPTION DRUG AIR AIR GAS RESPIRATORY (INHALATION) 19630101 UNAPPROVED MEDICAL GAS Medical-Technical Gases, Inc. AIR 1000 mL/L 10738-101_fa3baaf8-076f-45d6-b34b-672a75bf63b3 10738-101 HUMAN OTC DRUG PSORIASIS CONTROL SALICYLIC ACID CREAM TOPICAL 20111218 OTC MONOGRAPH FINAL part358H Genuine Virgin Aloe Corporation SALICYLIC ACID 2.5 g/100g 10738-102_7cca985b-e941-4369-9fab-7beee482f406 10738-102 HUMAN OTC DRUG ECZEMA FAST HEALING OATMEAL LOTION TOPICAL 20140103 OTC MONOGRAPH FINAL part347 Genuine Virgin Aloe Corporation OATMEAL 1.5 g/100g 10738-201_f0c0c44e-e540-4efe-936f-af1eda17d3a0 10738-201 HUMAN OTC DRUG PAIN RELIEF LIDOCAINE AND MENTHOL CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part348 Genuine Virgin Aloe Corporation LIDOCAINE; MENTHOL 4; 1.25 g/100g; g/100g 10738-301_13e130c1-4c6e-4cab-b55d-ec77f5afc3c4 10738-301 HUMAN OTC DRUG DIABETIC BRUISE DEFENSE ALLANTOIN CREAM TOPICAL 20140102 OTC MONOGRAPH FINAL part347 Genuine Virgin Aloe Corporation ALLANTOIN .5 g/100g 10738-302_e717d620-c9ab-4040-a916-344b12e238ea 10738-302 HUMAN OTC DRUG DIABETIC DRY SKIN DEFENSE ALLANTOIN AND DIMETHICONE CREAM TOPICAL 20140102 OTC MONOGRAPH FINAL part347 Genuine Virgin Aloe Corporation ALLANTOIN; DIMETHICONE 1.5; 1.5 g/100g; g/100g 10738-303_56dd132b-79de-4ca6-8e1f-f6645a86ecf4 10738-303 HUMAN OTC DRUG DIABETIC FOOT DEFENSE ALLANTOIN AND DIMETHICONE CREAM TOPICAL 20140102 OTC MONOGRAPH FINAL part347 Genuine Virgin Aloe Corporation ALLANTOIN; DIMETHICONE .5; 2 g/100g; g/100g 10738-304_52b3a32b-7f01-4aa2-83fe-19dd939db8df 10738-304 HUMAN OTC DRUG DIABETIC ULCER DEFENSE ALLANTOIN AND DIMETHICONE CREAM TOPICAL 20140102 OTC MONOGRAPH FINAL part347 Genuine Virgin Aloe Corporation ALLANTOIN; DIMETHICONE 1.1; 1.5 g/100g; g/100g 10742-0001_ae76a4fe-5c6e-4e26-b452-20b9627c6182 10742-0001 HUMAN OTC DRUG Mentholatum Camphor, menthol OINTMENT TOPICAL 19761213 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company CAMPHOR (SYNTHETIC); MENTHOL 90; 13 mg/g; mg/g 10742-0009_3537e599-65d9-48d6-8a46-d42312f71e84 10742-0009 HUMAN OTC DRUG Red Cross Toothache eugenol LIQUID TOPICAL 19830621 OTC MONOGRAPH NOT FINAL part356 The Mentholatum Company EUGENOL 850 mg/mL 10742-0204_4aa485fc-147e-4db9-a2b9-84eb044e3b99 10742-0204 HUMAN OTC DRUG OXY Cleansing Maximum Salicylic Acid SWAB TOPICAL 20020118 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/1 10742-1048_54bc5b4a-a051-4d12-b158-de9b8f7c8213 10742-1048 HUMAN OTC DRUG Mentholatum Natural Ice Cherry dimethicone, octinoxate, octisalate STICK TOPICAL 19990819 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE 10; 75; 50 mg/g; mg/g; mg/g 10742-1117_0bb93658-18a8-4e6a-bfe5-56e62bc18f63 10742-1117 HUMAN OTC DRUG Cold and Hot Medicated Menthol PATCH TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL 500 mg/1 10742-1118_0bb93658-18a8-4e6a-bfe5-56e62bc18f63 10742-1118 HUMAN OTC DRUG Cold and Hot Medicated Menthol PATCH TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL 240 mg/1 10742-1120_af72ff26-0c47-46c5-afa5-9fea36852b4b 10742-1120 HUMAN OTC DRUG Mentholatum Sports Pain Relief Warm Menthol, Methyl salicylate CREAM TOPICAL 20130603 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL; METHYL SALICYLATE 59.1; 128 mg/g; mg/g 10742-1204_22ff250c-4a50-4aa2-ab84-86c155d55c66 10742-1204 HUMAN OTC DRUG OXY Daily Defense Cleansing Pads Salicylic Acid SWAB TOPICAL 20130115 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/1 10742-1233_b3213f88-9496-4c89-ab1b-225bd81891c2 10742-1233 HUMAN OTC DRUG Phisoderm Clear Confidence Face Scrub Salicylic acid GEL TOPICAL 20120501 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/g 10742-1412_accafe6b-d350-4539-a39d-a9ee9a4fee29 10742-1412 HUMAN OTC DRUG Phisoderm Clear Confidence Daily Gel Face Wash Salicylic acid LIQUID TOPICAL 20120501 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/mL 10742-1442_e4c88ea1-5311-4e1f-a9ac-facef02b9c04 10742-1442 HUMAN OTC DRUG Phisoderm Clear Confidence Body Wash Salicylic Acid LIQUID TOPICAL 20120501 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/mL 10742-1509_4245e315-0f42-4c3a-9c86-8537af4005ed 10742-1509 HUMAN OTC DRUG Softlips Jack Frosting dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-1526_bf3711e7-6bfd-42c3-a84f-0a9e8428bda0 10742-1526 HUMAN OTC DRUG Softlips Jelly Bean dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20130215 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-1538_3fc12267-9196-410f-b2cb-b973dc02d778 10742-1538 HUMAN OTC DRUG Softlips Chocolate Bunny dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20130215 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-1566_f0ff27df-e011-47b0-bccf-9181fea60893 10742-1566 HUMAN OTC DRUG Softlips Coconut Cream Dimethicone, Octinoxate, Octisalate, Oxybenzone STICK TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-1567_db75c054-337c-47df-815d-b9120fb382c3 10742-1567 HUMAN OTC DRUG Softlips Peach Mango Dimethicone, Octinoxate, Octisalate, Oxybenzone OINTMENT TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-2002_113ba773-3f61-4d72-b3e8-21e6e11d1146 10742-2002 HUMAN OTC DRUG Mentholatum Deep Heating Rub Extra Strength Menthol, Methyl Salicylate CREAM TOPICAL 19921215 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL; METHYL SALICYLATE 80; 300 mg/g; mg/g 10742-2526_f831ec23-8dbd-4f84-8c59-d4c6dfa54771 10742-2526 HUMAN OTC DRUG Softlips Sugar Plum Berry Dimethicone, Octinoxate, Octisalate, Oxybenzone STICK TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-3004_90a3894f-6012-4db8-91e6-1cdb72b1c5c9 10742-3004 HUMAN OTC DRUG Mentholatum Natural Ice Original dimethicone, octinoxate, octisalate OINTMENT TOPICAL 19990119 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE 10; 75; 50 mg/g; mg/g; mg/g 10742-3051_2d7bd8c4-b978-4af5-a6db-b36e8f83e0ff 10742-3051 HUMAN OTC DRUG Softlips Vanilla dimethicone, octinoxate, octisalate, oxybenzone OINTMENT TOPICAL 19971119 OTC MONOGRAPH FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-4048_80150477-adda-4f75-b0df-06dd66f1a73a 10742-4048 HUMAN OTC DRUG Mentholatum Natural Ice Cherry lip protectant sunscreen OINTMENT TOPICAL 19990819 OTC MONOGRAPH FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE 10; 75; 50 mg/g; mg/g; mg/g 10742-6748_23ef354e-f5f3-49f2-9ca6-11dadf533c2d 10742-6748 HUMAN OTC DRUG Softlips Pure Lip Gloss Pink zinc oxide LIPSTICK TOPICAL 20100201 OTC MONOGRAPH FINAL part352 The Mentholatum Company ZINC OXIDE 65 mg/g 10742-6751_8ae990a7-9009-4494-97aa-4cc013a9e704 10742-6751 HUMAN OTC DRUG Softlips Pure Lip Gloss Natural zinc oxide LIPSTICK TOPICAL 20100201 OTC MONOGRAPH FINAL part352 The Mentholatum Company ZINC OXIDE 65 mg/g 10742-6752_132fe065-4453-41c0-8c0f-01f193e5978d 10742-6752 HUMAN OTC DRUG Softlips Pure Lip Gloss Coral zinc oxide LIPSTICK TOPICAL 20100201 OTC MONOGRAPH FINAL part352 The Mentholatum Company ZINC OXIDE 65 mg/g 10742-6754_59204504-a12a-49f5-a9c0-1d994f1bc9a1 10742-6754 HUMAN OTC DRUG Softlips Pure Tint Shell Pink Zinc oxide LIPSTICK TOPICAL 20100201 OTC MONOGRAPH FINAL part352 The Mentholatum Company ZINC OXIDE 65 mg/g 10742-6757_2a3ba19e-cd1a-409c-9a97-6500f6b159c5 10742-6757 HUMAN OTC DRUG Softlips Pure Tint Natural Honesty Zinc oxide LIPSTICK TOPICAL 20100201 OTC MONOGRAPH FINAL part352 The Mentholatum Company ZINC OXIDE 65 mg/g 10742-6758_ae90baa2-4f8b-46a6-b71b-9b323f990324 10742-6758 HUMAN OTC DRUG Softlips Pure Tint Coral Zinc oxide LIPSTICK TOPICAL 20100201 OTC MONOGRAPH FINAL part352 The Mentholatum Company ZINC OXIDE 65 mg/g 10742-6761_cc4e9750-d96c-4824-8234-032f6ee704fc 10742-6761 HUMAN OTC DRUG Softlips Pure Lip Butter Vanilla Berry Zinc oxide OINTMENT TOPICAL 20100101 OTC MONOGRAPH FINAL part352 The Mentholatum Company ZINC OXIDE 55 mg/g 10742-8080_e93e5c4b-0630-4d15-aae9-c78196dec3bf 10742-8080 HUMAN OTC DRUG Softlips Pearl Gloss Dimethicone, Octinoxate LIPSTICK TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE 20; 75 mg/mL; mg/mL 10742-8081_46e15c69-83a2-4270-afa5-5652c37ce59c 10742-8081 HUMAN OTC DRUG Softlips Coral Gloss Dimethicone, Octinoxate LIPSTICK TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE 20; 75 mg/mL; mg/mL 10742-8095_433822bb-8b2b-4fcf-a679-fc680c026393 10742-8095 HUMAN OTC DRUG Mentholatum for Kids Cough Suppressant camphor, eucalyptus oil, menthol natural OINTMENT TOPICAL 19930812 OTC MONOGRAPH FINAL part341 The Mentholatum Company CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 47; 12; 26 mg/g; mg/g; mg/g 10742-8112_b53319ce-ed4d-43a8-b118-944d2a6d8e5d 10742-8112 HUMAN OTC DRUG Mentholatum Nighttime Vaporizing Rub camphor, eucalyptus oil, menthol OINTMENT TOPICAL 20140714 OTC MONOGRAPH FINAL part341 The Mentholatum Company CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 48; 12; 26 mg/g; mg/g; mg/g 10742-8117_09c95d9b-aec9-47d2-93b4-1a33b44dd0ff 10742-8117 HUMAN OTC DRUG Cold and Hot Medicated Menthol PATCH TOPICAL 20080410 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL 50 mg/1 10742-8120_f1a09606-001c-4505-a537-447a9410593b 10742-8120 HUMAN OTC DRUG Mentholatum Pain Relief Muscle Rub Menthol, Methyl salicylate CREAM TOPICAL 20111003 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL; METHYL SALICYLATE 59.1; 128 mg/g; mg/g 10742-8123_e4fc76e4-2568-4efd-ba46-ef00e64d21fc 10742-8123 HUMAN OTC DRUG WellPatch Backache Pain Relief Menthol PATCH TOPICAL 20080118 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL 50 mg/1 10742-8126_a0243cfa-f0df-43fa-8ae4-98996a8fe581 10742-8126 HUMAN OTC DRUG WellPatch Capsaicin Pain Relief Capsaicin PATCH TOPICAL 20080228 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company CAPSAICIN .25 mg/1 10742-8129_d8e6ca2e-a4f7-4d77-86e2-6d247758d5a2 10742-8129 HUMAN OTC DRUG Mentholatum Sports Pain Relief Hot menthol, methyl salicylate LOTION TOPICAL 20130603 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL; METHYL SALICYLATE 60; 200 mg/mL; mg/mL 10742-8130_20b158a0-cfc1-4cb3-a87b-fcd39016d0aa 10742-8130 HUMAN OTC DRUG Mentholatum Pain Relief Deep Heating menthol, methyl salicylate LOTION TOPICAL 20111003 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL; METHYL SALICYLATE 60; 200 mg/mL; mg/mL 10742-8134_d7ea3cfc-dc14-4039-ac6b-7176dbe70cf5 10742-8134 HUMAN OTC DRUG Mentholatum Pain Relief Extra Strength Menthol GEL TOPICAL 20110808 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL 30 mg/mL 10742-8142_d552f0ed-92cf-409c-aad7-9c6fbf80dd4d 10742-8142 HUMAN OTC DRUG Rohto Cool Naphazoline hydrochloride, Polysorbate 80 LIQUID OPHTHALMIC 20010821 OTC MONOGRAPH FINAL part349 The Mentholatum Company NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80 .12; 2 mg/mL; mg/mL 10742-8143_dd760aba-e739-4db5-b516-1fdd51461fbd 10742-8143 HUMAN OTC DRUG Rohto Ice Hypromellose, Tetrahydrozoline hydrochloride, Zinc sulfate LIQUID OPHTHALMIC 20050927 OTC MONOGRAPH FINAL part349 The Mentholatum Company HYPROMELLOSES; TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE 2; .5; 2.5 mg/mL; mg/mL; mg/mL 10742-8144_bacaa4d7-c7b1-4b15-a640-35a82baa61c4 10742-8144 HUMAN OTC DRUG Rohto Arctic Hypromellose, Tetrahydrozoline hydrochloride LIQUID OPHTHALMIC 20060824 OTC MONOGRAPH FINAL part349 The Mentholatum Company HYPROMELLOSES; TETRAHYDROZOLINE HYDROCHLORIDE 3.5; .5 mg/mL; mg/mL 10742-8147_e1d40780-4873-4e5b-a82b-a014a86c70a9 10742-8147 HUMAN OTC DRUG Mentholatum Sports Pain Relief Cold Menthol GEL TOPICAL 20130615 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL 20 mg/g 10742-8148_61108b87-9e63-47c0-9a9d-b37217196c5a 10742-8148 HUMAN OTC DRUG Rohto Hydra Hydroxyethyl cellulose LIQUID OPHTHALMIC 20110103 OTC MONOGRAPH FINAL part349 The Mentholatum Company HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) 6 mg/mL 10742-8149_40d3f169-41dc-4efa-a976-7ca24c03e244 10742-8149 HUMAN OTC DRUG Rohto Relief hypromellose, tetrahydrozoline HCl, zinc sulfate LIQUID OPHTHALMIC 20111201 OTC MONOGRAPH FINAL part349 The Mentholatum Company HYPROMELLOSES; TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE 2; .5; 2.5 mg/mL; mg/mL; mg/mL 10742-8152_206ba879-130e-4913-b074-289a3cc9da01 10742-8152 HUMAN OTC DRUG Mentholatum Ironman Muscle Spray Extra Strength Menthol Camphor SPRAY TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company CAMPHOR; MENTHOL 40; 80 mg/g; mg/g 10742-8154_1d3d322c-d2bf-4470-a143-146a80b86ab5 10742-8154 HUMAN OTC DRUG Mentholatum Ironman Muscle and Joint Roll-On LOTION TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company CAPSAICIN; MENTHOL .25; 40 mg/mL; mg/mL 10742-8157_2e167988-748c-4339-b6b2-b0ab8e8e6ab3 10742-8157 HUMAN OTC DRUG Mentholatum Ironman Muscle Rub Camphor, Menthol GEL TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company CAMPHOR (SYNTHETIC); MENTHOL 30; 40 mg/g; mg/g 10742-8159_0493b71b-54ff-4f5e-9f44-5f07a3879a49 10742-8159 HUMAN OTC DRUG Rohto Cool Max Naphazoline hydrochloride, Polysorbate 80 LIQUID OPHTHALMIC 20140505 OTC MONOGRAPH FINAL part349 The Mentholatum Company NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80 .3; 2 mg/mL; mg/mL 10742-8163_94ed0b4f-2d17-4b46-a366-da47c4b2f69e 10742-8163 HUMAN OTC DRUG WellPatch Backache Pain Relief Menthol PATCH TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL 50 mg/1 10742-8212_74dbafbb-6b6c-471c-b4fe-73cf4584ed30 10742-8212 HUMAN OTC DRUG OXY Clinical Clearing Treatment Benzoyl peroxide CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part333 The Mentholatum Company BENZOYL PEROXIDE 50 mg/g 10742-8214_1b3302d8-46dd-4a36-9854-843706580318 10742-8214 HUMAN OTC DRUG OXY Clinical Advanced Face Wash Salicylic acid LIQUID TOPICAL 20100601 OTC MONOGRAPH FINAL part333 The Mentholatum Company SALICYLIC ACID 20 mg/mL 10742-8218_86ebd90c-9c7c-4d05-9ae4-f54246ef2d3d 10742-8218 HUMAN OTC DRUG OXY Clinical Foaming Face Wash Salicylic Acid SOLUTION TOPICAL 20110516 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/mL 10742-8219_9c801504-5cc7-47e8-b40b-c2e0604664bc 10742-8219 HUMAN OTC DRUG Oxy Face Wash Mild Benzoyl Peroxide LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 50 mg/mL 10742-8221_8e017d71-f068-480b-9de5-4dc5f8b0c064 10742-8221 HUMAN OTC DRUG OXY Clinical Hydrating Therapy Salicylic acid CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part333 The Mentholatum Company SALICYLIC ACID 5 mg/g 10742-8223_89cdc287-e374-4254-b867-97e9f9b6bdd1 10742-8223 HUMAN OTC DRUG Oxy Maximum Action Face Wash Benzoyl Peroxide LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 100 mg/mL 10742-8233_8475b379-0912-4843-9972-823e3ee710a1 10742-8233 HUMAN OTC DRUG OXY Purifying Face Scrub Maximum Salicylic Acid GEL TOPICAL 20090601 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/g 10742-8236_be00bbda-d913-405a-bfe7-e6330f694965 10742-8236 HUMAN OTC DRUG OXY Hydrating Body Wash Salicylic Acid LIQUID TOPICAL 20100802 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/mL 10742-8267_916ad124-a098-4887-87df-102c298f5416 10742-8267 HUMAN OTC DRUG OXY Daily Moisturizer Maximum Salicylic Acid LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333 The Mentholatum Company SALICYLIC ACID 5 mg/g 10742-8271_858d3da0-2fce-4370-a024-9f6a244c55a5 10742-8271 HUMAN OTC DRUG Oxy Daily Defense Face Wash Salicylic acid CREAM TOPICAL 20130115 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/g 10742-8283_e90ba623-246a-428d-b4cd-c07994805ffc 10742-8283 HUMAN OTC DRUG Oxy Maximum Action Face Wash Sensitive Benzoyl Peroxide LIQUID TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 50 mg/mL 10742-8285_8204d33a-13c3-49be-be13-ddd1ddf3821c 10742-8285 HUMAN OTC DRUG OXY Exfoliating Body Scrub Salicylic acid GEL TOPICAL 20100802 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 10 mg/mL 10742-8291_cc52538f-c9b7-41c1-a143-c58bc0a79690 10742-8291 HUMAN OTC DRUG Oxy Daily Defense Exfoliating Body Scrub Salicylic acid GEL TOPICAL 20130115 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 10 mg/mL 10742-8293_2a51c80a-27e8-44d3-b06f-b2a9081c5796 10742-8293 HUMAN OTC DRUG Phisoderm Clear Confidence Spot Treatment benzoyl peroxide CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 25 mg/g 10742-8301_d694813f-be87-4519-af28-65a22df61623 10742-8301 HUMAN OTC DRUG Oxy Maximum Action Spot Treatment benzoyl peroxide CREAM TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 100 mg/g 10742-8302_9f408142-dc98-4cd9-9060-64c42984ee9a 10742-8302 HUMAN OTC DRUG Oxy Maximum Action Spot Treatment Tinted benzoyl peroxide CREAM TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 100 mg/g 10742-8306_b3f40a73-3c07-4af8-b1a1-1afef56139ca 10742-8306 HUMAN OTC DRUG Oxy Daily Defense Exfoliating Face Scrub Salicylic acid GEL TOPICAL 20130115 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/g 10742-8307_38cffa5b-f7b2-4b63-b8d0-2accf634661e 10742-8307 HUMAN OTC DRUG Oxy Daily Defense Facial Cleanser Salicylic acid LIQUID TOPICAL 20130115 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/mL 10742-8308_5a3f8bbf-22be-427b-83a9-f5573232ed5f 10742-8308 HUMAN OTC DRUG Oxy Maximum Action Advanced Face Wash Sensitive Benzoyl Peroxide CREAM TOPICAL 20130701 OTC MONOGRAPH FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 50 mg/mL 10742-8341_25a080a0-28f4-4904-a567-1b1382c267bb 10742-8341 HUMAN OTC DRUG OXY Daily Defense Advanced Facial Cleanser Tropical Berry Extract Salicylic acid LIQUID TOPICAL 20131118 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/mL 10742-8342_f42aa4ac-0b8e-4192-974d-932c8d020d5d 10742-8342 HUMAN OTC DRUG OXY Daily Defense Advanced Facial Cleanser Citrus Extract Salicylic acid LIQUID TOPICAL 20131118 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/mL 10742-8345_7b537288-cfc7-4e04-b3e3-b16e07b0b617 10742-8345 HUMAN OTC DRUG OXY Clinical Advanced Treatment Salicylic Acid SWAB TOPICAL 20110516 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/1 10742-8349_734dd2ce-006f-4a94-8eb7-da982c7270f3 10742-8349 HUMAN OTC DRUG OXY Cleansing Pads Mild Salicylic Acid SWAB TOPICAL 20120201 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 5 mg/1 10742-8352_446ebfb1-df0f-425b-a660-947277337ba5 10742-8352 HUMAN OTC DRUG OXY Maximum Action Treatment Pads benzoyl peroxide SWAB TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 25 mg/1 10742-8357_27207b83-cdcd-4c5a-81c8-2ca92d6fea91 10742-8357 HUMAN OTC DRUG Oxy Daily Defense Cleansing Pads Sensitive Salicylic Acid SWAB TOPICAL 20130115 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 5 mg/1 10742-8359_ff40cfe7-973b-4e30-85dd-93766d0dec10 10742-8359 HUMAN OTC DRUG OXY Maximum Action 3 in 1 Treatment Pads Salicylic Acid SWAB TOPICAL 20140501 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/1 10742-8361_4cc02e46-bfae-4f53-8aa4-4662a32339f9 10742-8361 HUMAN OTC DRUG OXY Daily Defense Advanced Facial Cleanser Aloe Cucumber Extract Salicylic acid LIQUID TOPICAL 20131118 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/mL 10742-8364_4dbd29bd-1948-4f25-b25d-c48b68029953 10742-8364 HUMAN OTC DRUG OXY Daily Defense Ultra Facial Cleanser Salicylic acid CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/g 10742-8365_03e0226b-ed02-4074-bc2f-f46db4e5a4a4 10742-8365 HUMAN OTC DRUG Oxy Maximum Action Advanced Face Wash benzoyl peroxide CREAM TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 100 mg/mL 10742-8368_6ca13021-2f89-45f6-876d-54127657c3c3 10742-8368 HUMAN OTC DRUG Hada Labo Tokyo Protecting Day SPF 18 Avobenzone, Octinoxate, Octisalate, Octocrylene LOTION TOPICAL 20130617 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 20; 75; 25; 18 mg/mL; mg/mL; mg/mL; mg/mL 10742-8379_09d48cdb-7c52-4838-8fb0-8e49a8e1276a 10742-8379 HUMAN OTC DRUG Hada Labo Tokyo Protecting Day SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20140714 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 20; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10742-8417_9fd851bf-1113-488b-ad16-1a3ce52a87d5 10742-8417 HUMAN OTC DRUG Phisoderm Anti-Blemish Gel Cleanser Salicylic acid GEL TOPICAL 20130901 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/g 10742-8451_bba14225-2970-4678-b5a1-78ed94c389d9 10742-8451 HUMAN OTC DRUG Phisoderm Anti Blemish Body Wash Salicylic Acid LIQUID TOPICAL 20130901 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/mL 10742-8456_7bf28d42-7dc3-421e-8191-28a7ea520e5d 10742-8456 HUMAN OTC DRUG Softlips Intense Moisture Double Mint dimethicone, octinoxate, oxybenzone STICK TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OXYBENZONE 20; 75; 30 mg/g; mg/g; mg/g 10742-8457_a5da15cc-1aa6-4a7f-a845-de45b8dbece3 10742-8457 HUMAN OTC DRUG Softlips Intense Moisture Citrus Mint dimethicone, octinoxate, oxybenzone STICK TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OXYBENZONE 20; 75; 30 mg/g; mg/g; mg/g 10742-8458_7e670db4-12b3-4a22-8b3a-f82fb66ccd2c 10742-8458 HUMAN OTC DRUG Softlips Intense Moisture Berry Mint dimethicone, octinoxate, oxybenzone STICK TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OXYBENZONE 20; 75; 30 mg/g; mg/g; mg/g 10742-8470_37951803-d74d-4504-b8f2-de648e019e23 10742-8470 HUMAN OTC DRUG Softlips Raspberry dimethicone, octinoxate, octisalate, oxybenzone OINTMENT TOPICAL 20070112 OTC MONOGRAPH FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8473_4d0eb807-e537-42ef-8510-bd29e9255775 10742-8473 HUMAN OTC DRUG Softlips Birthday Cake dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8476_03062f13-270d-49cf-8939-2349f12e9cba 10742-8476 HUMAN OTC DRUG Softlips Watermelon dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20120416 OTC MONOGRAPH FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; ug/g 10742-8507_b3d63a29-c95c-41a7-8ae5-989ae0f4164a 10742-8507 HUMAN OTC DRUG Softlips Sugar and Spice Dimethicone, Octinoxate, Octisalate, Oxybenzone STICK TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8510_8d55141d-5d6f-4eec-87dc-d3c808cf7a6a 10742-8510 HUMAN OTC DRUG Softlips Marshmallow Ghost dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20121001 OTC MONOGRAPH FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; ug/g 10742-8512_45306edc-b749-4f0e-9601-5a4493159140 10742-8512 HUMAN OTC DRUG Softlips Cherry dimethicone, octinoxate, octisalate, oxybenzone OINTMENT TOPICAL 20000420 OTC MONOGRAPH FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8520_86ca6144-5666-4c87-840c-ca9d522d867f 10742-8520 HUMAN OTC DRUG Softlips Mint with a hint of vanilla dimethicone, octinoxate, octisalate, oxybenzone OINTMENT TOPICAL 20100111 OTC MONOGRAPH FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8526_304e3ac0-2eec-4550-8c90-555d381ca86f 10742-8526 HUMAN OTC DRUG Softlips Berry Lip Protectant Sunscreen OINTMENT TOPICAL 20100201 OTC MONOGRAPH FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8541_3e7985de-a8e5-4063-be44-4392e5347fec 10742-8541 HUMAN OTC DRUG Softlips Praline Brownie dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8543_252498c9-2641-4c3d-bd5d-4d271dda3953 10742-8543 HUMAN OTC DRUG Softlips Salted Caramel dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8561_71753623-9a86-4c38-a76a-a281791579c0 10742-8561 HUMAN OTC DRUG Softlips Pearl octinoxate, octisalate LIPSTICK TOPICAL 20080820 OTC MONOGRAPH FINAL part352 The Mentholatum Company OCTINOXATE; OCTISALATE 75; 50 mg/g; mg/g 10742-8562_d0cfe8e4-1796-4f92-8475-1edcb574ebae 10742-8562 HUMAN OTC DRUG Softlips Winter Mint dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20080118 OTC MONOGRAPH FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8563_93e1cf03-65e6-4a1f-a5bd-7848332dc983 10742-8563 HUMAN OTC DRUG Softlips Pearl octinoxate, octisalate STICK TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company OCTINOXATE; OCTISALATE 75; 50 mg/g; mg/g 10742-8564_df51ffcc-3d86-4502-8be6-7c073811580a 10742-8564 HUMAN OTC DRUG Softlips Sugar Skin Protectant Sunscreen OINTMENT TOPICAL 20100101 OTC MONOGRAPH FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8566_8a033558-5a1c-4019-9f76-c718d14cf566 10742-8566 HUMAN OTC DRUG Softlips Coconut lip protectant sunscreen OINTMENT TOPICAL 20100201 OTC MONOGRAPH FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8567_bff3d6be-e7cd-428f-8914-b46c0d3d25ce 10742-8567 HUMAN OTC DRUG Softlips Peach Mango lip protectant sunscreen OINTMENT TOPICAL 20100201 OTC MONOGRAPH FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8580_7acc182a-5760-4e74-b829-ddd91efd958d 10742-8580 HUMAN OTC DRUG Softlips Strawberry dimethicone, octinoxate, octisalate, oxybenzone OINTMENT TOPICAL 20060620 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8582_8af207c3-b3dd-479e-90ee-f262e9a84d2f 10742-8582 HUMAN OTC DRUG Softlips Tint Rose Octinoxate, Octisalate LIPSTICK TOPICAL 20070720 OTC MONOGRAPH FINAL part352 The Mentholatum Company OCTINOXATE; OCTISALATE 75; 50 mg/g; mg/g 10742-8584_2e454477-1e00-4865-9681-48e6ff983c3b 10742-8584 HUMAN OTC DRUG Softlips Tint Bronze Octinoxate, Octisalate LIPSTICK TOPICAL 20070720 OTC MONOGRAPH FINAL part352 The Mentholatum Company OCTINOXATE; OCTISALATE 75; 50 mg/g; mg/g 10742-8596_33b392cb-f282-40dd-a78d-3571970695f7 10742-8596 HUMAN OTC DRUG Softlips Flavor Fusions Strawberry Banana dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8597_1351c598-aa97-4a24-9f42-5915c17d7c85 10742-8597 HUMAN OTC DRUG Softlips Flavor Fusions Blackberry Lemonade dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8598_454cc1e7-99a0-4dfd-9115-b1b5b90d950a 10742-8598 HUMAN OTC DRUG Softlips Flavor Fusions Pomegranate Blueberry dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8652_7dbd2193-088a-4ce5-94ce-b25a4bd914c1 10742-8652 HUMAN OTC DRUG Softlips Flavor Fusions Chocolate Mint Gelato dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20131011 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8662_17e04ba5-957f-4d3d-9e67-cbc8581ae457 10742-8662 HUMAN OTC DRUG Softlips Tint Blossom Octinoxate, Octisalate LIPSTICK TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company OCTINOXATE; OCTISALATE 75; 50 mg/g; mg/g 10742-8663_eeea800a-f36a-4d63-878e-23f9f94385c5 10742-8663 HUMAN OTC DRUG Softlips Tint Honey Octinoxate, Octisalate LIPSTICK TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company OCTINOXATE; OCTISALATE 75; 50 mg/g; mg/g 10742-8667_7198d82d-6d7f-454e-b861-a979d62e1a48 10742-8667 HUMAN OTC DRUG Softlips Cube Pomegranate Blueberry dimethicone, octinoxate, oxybenzone OINTMENT TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OXYBENZONE 20; 75; 30 mg/g; mg/g; mg/g 10742-8668_7e73add8-6e3e-4e83-818b-def680a8da21 10742-8668 HUMAN OTC DRUG Softlips Cube Vanilla Bean dimethicone, octinoxate, oxybenzone OINTMENT TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OXYBENZONE 20; 75; 30 mg/g; mg/g; mg/g 10742-8669_ed617f25-ed88-41bf-b7f6-7ec7ddfcf0f8 10742-8669 HUMAN OTC DRUG Softlips Cube Fresh Mint dimethicone, octinoxate, oxybenzone OINTMENT TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OXYBENZONE 20; 75; 30 mg/g; mg/g; mg/g 10742-8682_21c13111-d2a3-41f2-ac1a-5d2aa57c4a66 10742-8682 HUMAN OTC DRUG Softlips Cube Strawberry dimethicone, octinoxate, oxybenzone OINTMENT TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OXYBENZONE 20; 75; 30 mg/g; mg/g; mg/g 10742-8729_85d1dc2b-f349-4b8a-bfeb-32126d54d073 10742-8729 HUMAN OTC DRUG Mentholatum Natural Chest Rub Menthol natural OINTMENT TOPICAL 20100802 OTC MONOGRAPH FINAL part341 The Mentholatum Company MENTHOL 27 mg/g 10742-8782_b458de26-3774-4924-89b9-1c9d6d563602 10742-8782 HUMAN OTC DRUG Softlips Replenish dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20100712 OTC MONOGRAPH FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g 10742-8902_cbd41429-f730-4577-9f06-ef1831cf62e1 10742-8902 HUMAN OTC DRUG Red Cross Oral Pain Relief benzocaine LIQUID TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part356 The Mentholatum Company BENZOCAINE 200 mg/mL 10742-8932_00b58001-f775-4a34-93b6-5fbbe9414599 10742-8932 HUMAN OTC DRUG Softlips Lip Relief skin protectant/topical analgesic OINTMENT TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company ALLANTOIN; MENTHOL 10; 5 mg/g; mg/g 10742-8980_86460b38-2863-4870-a1ae-7abb554af586 10742-8980 HUMAN OTC DRUG Mentholatum Natural Ice Sport SPF 30 avobenzone, dimethicone, octinoxate, octisalate OINTMENT TOPICAL 20000329 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company AVOBENZONE; DIMETHICONE; OCTINOXATE; OCTISALATE 30; 10; 75; 50 mg/g; mg/g; mg/g; mg/g 10755-006_17ac1766-5878-4589-8483-b0bbade82e3b 10755-006 HUMAN OTC DRUG islander spf6 Octinoxate, Octisalate, Avobenzone, Octocrylene LOTION TOPICAL 20090801 OTC MONOGRAPH FINAL part352 Island Company Lifestyle Products, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 50; 30; 15; 20 mg/g; mg/g; mg/g; mg/g; mg/g 10755-015_214866e1-4170-48cb-b415-32edfb50bdd8 10755-015 HUMAN OTC DRUG traveler spf15 Octinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene LOTION TOPICAL 20090801 OTC MONOGRAPH FINAL part352 Island Company Lifestyle Products, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 50; 30; 15; 20 mg/g; mg/g; mg/g; mg/g; mg/g 10755-030_22787fc1-a5d6-49f5-b18c-3b660349922f 10755-030 HUMAN OTC DRUG tourist spf30 Octinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene LOTION TOPICAL 20090801 OTC MONOGRAPH FINAL part352 Island Company Lifestyle Products, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 75; 50; 15; 50 mg/g; mg/g; mg/g; mg/g; mg/g 10768-7085_7732561c-7e6b-4c74-a3b3-a8b9169898d4 10768-7085 HUMAN PRESCRIPTION DRUG Perrigo Prednisone Prednisone TABLET ORAL 20061011 ANDA ANDA083677 Perrigo Pharmaceuticals Company PREDNISONE 20 mg/1 10768-7167_ad00f8ec-95a2-4f5b-8036-fe8f23e633e0 10768-7167 HUMAN PRESCRIPTION DRUG Perrigo Ibuprofen ibuprofen TABLET ORAL 20060316 ANDA ANDA077114 Perrigo Pharmaceuticals Company IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10768-7283_a53aeafb-c3aa-47ad-bbaa-416cfabeb248 10768-7283 HUMAN PRESCRIPTION DRUG Perrigo Prednisone Prednisone TABLET ORAL 20060519 ANDA ANDA088832 Perrigo Pharmaceuticals Company PREDNISONE 10 mg/1 10768-7522_bbd34727-fde4-4065-9b08-28136a6848b1 10768-7522 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20060508 ANDA ANDA077114 Perrigo Pharmaceuticals Company IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 10768-7733_a5536555-5b9d-49ae-bfe9-968816637787 10768-7733 HUMAN PRESCRIPTION DRUG Perrigo Prednisone Prednisone TABLET ORAL 20060519 ANDA ANDA080292 Perrigo Pharmaceuticals Company PREDNISONE 5 mg/1 10802-1202_6ac058ea-d4f4-4fcd-83e1-5f2adb8652e6 10802-1202 HUMAN PRESCRIPTION DRUG Ergomar Ergotamine Tartrate TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20120831 ANDA ANDA087693 Rosedale Therapeutics ERGOTAMINE TARTRATE 2 mg/1 Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient] 10812-002_84576aa7-ca5e-4382-afde-a9888f6056b6 10812-002 HUMAN OTC DRUG Neutrogena Deep Moisture Day with Sunscreen Broad Spectrum SPF20 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/g; mg/g; mg/g; mg/g 10812-006_711ccd32-3c66-49be-a803-faa7c361bb6b 10812-006 HUMAN OTC DRUG Neutrogena Healthy Defense SPF30 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20091201 20150102 OTC MONOGRAPH FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 50; 30 mg/mL; mg/mL 10812-007_6aaae454-6c8b-41b2-a456-42455775b4b1 10812-007 HUMAN OTC DRUG Neutrogena Healthy Defense SPF50 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20130625 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 50; 30 mg/mL; mg/mL 10812-008_0ef6d836-2514-433a-8fa2-c06ce66b53fa 10812-008 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Fresh Plum 60 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g 10812-009_82084629-8fc2-4cad-91bd-00d534638388 10812-009 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Sheer Shimmer 10 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g 10812-010_8fd017f9-146c-402a-9362-234251e2f223 10812-010 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Soft Caramel 50 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g 10812-011_69b7dd44-4290-4245-ba2b-8dffd578977e 10812-011 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Healthy Blush 20 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g 10812-012_6f5f0e28-0e8c-4b2e-bb4d-a9b4882e5d19 10812-012 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Sunny Berry 30 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g 10812-013_9bd87280-e938-49b1-b2b0-531bda55bcc0 10812-013 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Petal Glow 40 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g 10812-014_29d0b206-f416-4ecb-8eb4-bc917a310d49 10812-014 HUMAN OTC DRUG Neutrogena Naturals Acne Foaming Scrub Salicylic Acid LOTION TOPICAL 20121101 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 10 mg/mL 10812-024_c6cc01eb-70a9-4c15-b627-c809ae66eb46 10812-024 HUMAN OTC DRUG Neutrogena Naturals Acne Spot Treatment Salicylic Acid LOTION TOPICAL 20121101 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 10 mg/mL 10812-034_519347e2-5f2d-42a5-9b77-2bf57543bd5d 10812-034 HUMAN OTC DRUG Neutrogena Naturals Acne Cleanser Salicylic Acid LOTION TOPICAL 20121101 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 10 mg/mL 10812-036_318e593a-e4f9-483f-bd2b-a32ec40ad44c 10812-036 HUMAN OTC DRUG Neutrogena All-in-1 Acne Control Facial Treatment Salicylic Acid CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 1 mg/g 10812-039_077ae37c-4418-4834-be98-e08de1ade0ea 10812-039 HUMAN OTC DRUG Neutrogena TGel Therapeutic Conditioner Salicylic Acid LIQUID TOPICAL 20120330 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-040_09d3eaa4-ee96-44dc-bdde-597b2a58499b 10812-040 HUMAN OTC DRUG Neutrogena Body Clear Body Scrub Salicylic Acid LIQUID TOPICAL 20120316 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-041_11aed02e-3e03-4905-a052-533c9cd473ed 10812-041 HUMAN OTC DRUG Neutrogena Body Clear Salicylic Acid SPRAY TOPICAL 20100601 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5 mg/mL 10812-042_05926033-0961-4628-a1c8-9caff3b9c353 10812-042 HUMAN OTC DRUG Neutrogena Spectrum Plus Face Advanced Oil Free Sunscreen Broad Spectrum SPF100 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121022 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-043_903aa365-0e25-4dea-9e5b-1c2711b2e74d 10812-043 HUMAN OTC DRUG Neutrogena Spectrum Plus Advanced Sunscreen Broad Spectrum SPF100 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-068_a8181fa1-f5c4-46a1-9555-cb215a72a318 10812-068 HUMAN OTC DRUG Neutrogena Clear Pore Acne Treatment Benzoyl Peroxide CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part333D Neutrogena Corporation BENZOYL PEROXIDE 50 mg/g 10812-085_f8c5bac4-e286-47a9-8b19-1a47cd5670cb 10812-085 HUMAN OTC DRUG Neutrogena Oil Free Acne Stress Control Salicylic Acid GEL TOPICAL 20110401 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-091_6914ca93-81b6-4fd2-8328-ec9506e65d3d 10812-091 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup SPF 55 Classic Ivory 10 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g 10812-092_6914ca93-81b6-4fd2-8328-ec9506e65d3d 10812-092 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup SPF55 Natural Ivory 20 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g 10812-093_6914ca93-81b6-4fd2-8328-ec9506e65d3d 10812-093 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup SPF 55 Buff 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g 10812-094_6914ca93-81b6-4fd2-8328-ec9506e65d3d 10812-094 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup SPF Nude 40 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g 10812-095_6914ca93-81b6-4fd2-8328-ec9506e65d3d 10812-095 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup SPF55 Soft Beige 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g 10812-096_6914ca93-81b6-4fd2-8328-ec9506e65d3d 10812-096 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup SPF 55 Natural Beige 60 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g 10812-097_6914ca93-81b6-4fd2-8328-ec9506e65d3d 10812-097 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup SPF55 Fresh Beige 70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g 10812-098_6914ca93-81b6-4fd2-8328-ec9506e65d3d 10812-098 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup SPF 55 Warm Beige 90 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g 10812-100_7ffc6ef4-72fd-495e-ac40-1c6d6fc1c511 10812-100 HUMAN OTC DRUG Neutrogena Clear Face Break-Out Free Sunscreen SPF 30 Helioplex Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20101101 20151019 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25; 50; 40; 30; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-101_7ca149c6-7628-4068-9384-7fdc212885ca 10812-101 HUMAN OTC DRUG Neutrogena Clear Face Break-Out Free Sunscreen SPF 55 Helioplex Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20101101 20151019 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27; 40; 45; 60; 45 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-102_93c85e55-f8b1-44fe-8cf9-4a922a197c41 10812-102 HUMAN OTC DRUG Neutrogena Men Skin Clearing Acne Wash Salicylic Acid LIQUID TOPICAL 20111201 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-106_1e30fcb8-c9bd-4d26-8493-21ea8c4962ba 10812-106 HUMAN OTC DRUG Neutrogena Oil-Free Moisture Sunscreen Broad Spectrum SPF 35 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 23.5; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-107_b17f5668-ef1b-4a43-9973-084ef8ff8247 10812-107 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Cleansing Salicylic Acid CLOTH TOPICAL 20120329 20151101 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/1 10812-109_c09a8205-f616-451f-b2d8-28f12397b5a6 10812-109 HUMAN OTC DRUG Neutrogena Healthy Defense Daily Moisturizer Sunscreen SPF30 Light Tint Ensulizole, Octinoxate, Octocrylene, Zinc Oxide LOTION TOPICAL 20130628 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 20; 75; 75; 19 mg/mL; mg/mL; mg/mL; mg/mL 10812-114_5c7a1a07-f7e7-46e4-8b26-a9320d7fb741 10812-114 HUMAN OTC DRUG Neutrogena Clear Pore Cleanser Mask Benzoyl Peroxide LOTION TOPICAL 20110727 OTC MONOGRAPH NOT FINAL part333D Neutrogena Corporation BENZOYL PEROXIDE 35 mg/mL 10812-121_4c317892-d88f-4c1b-9c29-6f5d9e121095 10812-121 HUMAN OTC DRUG Neutrogena SkiniD Anti Acne Treatment Benzoyl Peroxide LIQUID TOPICAL 20111222 OTC MONOGRAPH FINAL part333D Neutrogena Corporation BENZOYL PEROXIDE 50 mg/mL 10812-128_8985de26-76be-4f03-b91e-929798d1ce5e 10812-128 HUMAN OTC DRUG Neutrogena Rapid Clear 2 in 1 Fight and Fade Toner Salicylic Acid LIQUID TOPICAL 20100325 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-129_a9afd2e7-7824-40bf-a5e4-27e3e7bdf333 10812-129 HUMAN OTC DRUG Neutrogena Blackhead Eliminating Daily Scrub Salicylic Acid LIQUID TOPICAL 20120320 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-130_a8ae89bc-7385-4b61-996f-a153e1259954 10812-130 HUMAN OTC DRUG Neutrogena Clinical Lifting Wrinkle Treatment System Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20100415 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-131_ae6248ba-2b28-41c5-a61c-0cbf35eccbcf 10812-131 HUMAN OTC DRUG Neutrogena Men Triple Protect Face SPF20 Ensulizole, Octinoxate, and Oxybenzone LOTION TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation ENSULIZOLE; OCTINOXATE; OXYBENZONE 10; 60; 20 mg/mL; mg/mL; mg/mL 10812-146_ce00df82-dcbd-4818-9814-96785730a289 10812-146 HUMAN OTC DRUG Neutrogena Age Defense Anti Oxidant Daily Moisturizer SPF20 Sheer Tint Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20111031 20150101 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL 10812-147_a3b0be6c-2cfb-49cd-a139-882bceae79f1 10812-147 HUMAN OTC DRUG Neutrogena Age Defense Anti Oxidant Daily Moisturizer SPF20 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20111031 20150101 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 18; 70; 40; 15; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-152_3c944d47-9654-45a8-8498-8dc20049a9dd 10812-152 HUMAN OTC DRUG Neutrogena Tgel Daily Control 2 in 1 Pyrithione Zinc SHAMPOO TOPICAL 20110221 OTC MONOGRAPH FINAL part358H Neutrogena Corporation PYRITHIONE ZINC 10 mg/mL 10812-153_94be4f43-021b-456d-94c7-6e741d18aeda 10812-153 HUMAN OTC DRUG Neutrogena Rapid Clear Acne Defense Face Salicylic Acid LOTION TOPICAL 20120330 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-166_9c1962cd-5c41-4c20-a940-0ac9c58c86a1 10812-166 HUMAN OTC DRUG Neutrogena Healthy Skin Enhancer Sunscreen Broad Spectrum SPF20 - Fair to Light 20 Octinoxate, Octisalate, and Titanium Dioxide LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 70; 30; 51 mg/mL; mg/mL; mg/mL 10812-167_9c1962cd-5c41-4c20-a940-0ac9c58c86a1 10812-167 HUMAN OTC DRUG Neutrogena Healthy Skin Enhancer Sunscreen Broad Spectrum SPF20 - Ivory to Fair 10 Octinoxate, Octisalate, and Titanium Dioxide LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 70; 30; 51 mg/mL; mg/mL; mg/mL 10812-168_9c1962cd-5c41-4c20-a940-0ac9c58c86a1 10812-168 HUMAN OTC DRUG Neutrogena Healthy Skin Enhancer Sunscreen Broad Spectrum SPF20 - Light to Neutral 30 Octinoxate, Octisalate, and Titanium Dioxide LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 70; 30; 51 mg/mL; mg/mL; mg/mL 10812-169_9c1962cd-5c41-4c20-a940-0ac9c58c86a1 10812-169 HUMAN OTC DRUG Neutrogena Healthy Skin Enhancer Sunscreen Broad Spectrum SPF20 - Tan to Medium 50 Octinoxate, Octisalate, and Titanium Dioxide LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 70; 30; 51 mg/mL; mg/mL; mg/mL 10812-170_9c1962cd-5c41-4c20-a940-0ac9c58c86a1 10812-170 HUMAN OTC DRUG Neutrogena Healthy Skin Enhancer Sunscreen Broad Spectrum SPF20 - Medium to Olive 60 Octinoxate, Octisalate, and Titanium Dioxide LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 70; 30; 51 mg/mL; mg/mL; mg/mL 10812-171_9c1962cd-5c41-4c20-a940-0ac9c58c86a1 10812-171 HUMAN OTC DRUG Neutrogena Healthy Skin Enhancer Sunscreen Broad Spectrum SPF20 - Neutral to Tan 40 Octinoxate, Octisalate, and Titanium Dioxide LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 70; 30; 51 mg/mL; mg/mL; mg/mL 10812-173_2bb78c85-7af4-4f64-844a-4ea29aee2976 10812-173 HUMAN OTC DRUG Neutrogena Clinical Lifting Wrinkle Treatment System Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20100415 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-188_b70f7a65-912a-4727-83af-c2a19ac3d3df 10812-188 HUMAN OTC DRUG Neutrogena Visibly Even Daily Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130618 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-192_4e33fb3b-7bb2-4927-aa46-f6899608848b 10812-192 HUMAN OTC DRUG Neutrogena Fresh Cooling Sunscreen Body Mist Broad Spectrum SPF45 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20121018 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 23.5; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-193_67d5d0f8-d16a-4111-abdc-5bf5b9ec872b 10812-193 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch SPF55 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120312 20160801 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-198_ca275cf8-b7a5-4d8b-872b-0c7b9c78b44a 10812-198 HUMAN OTC DRUG Neutrogena MoistureShine Lip Soother Sunscreen SPF20 - Gleam 40 Octinoxate and Oxybenzone GEL TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 20 mg/g; mg/g 10812-199_ca275cf8-b7a5-4d8b-872b-0c7b9c78b44a 10812-199 HUMAN OTC DRUG Neutrogena MoistureShine Lip Soother Sunscreen SPF20 - Shimmer 10 Octinoxate and Oxybenzone GEL TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 20 mg/g; mg/g 10812-200_ca275cf8-b7a5-4d8b-872b-0c7b9c78b44a 10812-200 HUMAN OTC DRUG Neutrogena MoistureShine Lip Soother Sunscreen SPF20 - Sheen 50 Octinoxate and Oxybenzone GEL TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 20 mg/g; mg/g 10812-201_ca275cf8-b7a5-4d8b-872b-0c7b9c78b44a 10812-201 HUMAN OTC DRUG Neutrogena MoistureShine Lip Soother Sunscreen SPF20 - Shine 30 Octinoxate and Oxybenzone GEL TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 20 mg/g; mg/g 10812-202_ca275cf8-b7a5-4d8b-872b-0c7b9c78b44a 10812-202 HUMAN OTC DRUG Neutrogena MoistureShine Lip Soother Sunscreen SPF20 - Glaze 60 Octinoxate and Oxybenzone GEL TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 20 mg/g; mg/g 10812-203_ca275cf8-b7a5-4d8b-872b-0c7b9c78b44a 10812-203 HUMAN OTC DRUG Neutrogena MoistureShine Lip Soother Sunscreen SPF20 - Glisten 20 Octinoxate and Oxybenzone GEL TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 20 mg/g; mg/g 10812-204_17f5c5e8-dc6c-4617-965a-ba1e0518f50b 10812-204 HUMAN OTC DRUG Neutrogena Rapid Clear Salicylic Acid SWAB TOPICAL 20100209 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 20 mg/1 10812-205_cbaa4aad-7943-4720-b19d-e8009aa7c78c 10812-205 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Daily Scrub with Microclear Technology Salicylic Acid LIQUID TOPICAL 20110315 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-206_9e6b594d-2531-4ce8-8c91-6f090993ada0 10812-206 HUMAN OTC DRUG Neutrogena Rapid Clear Acne Eliminating Spot Salicylic Acid GEL TOPICAL 20111013 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-208_3e47cce3-41fb-4cf5-bd7e-f966d2ae2fe2 10812-208 HUMAN OTC DRUG Neutrogena Men Age Fighter Moisturizer Sunscreen SPF15 Ensulizole and Octinoxate CREAM TOPICAL 20121113 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation ENSULIZOLE; OCTINOXATE 10; 60 mg/g; mg/g 10812-209_f6bc15da-eac9-4d82-9b66-f04800c58d5f 10812-209 HUMAN OTC DRUG Neutrogena Men Age Fighter Face Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 15; 50; 30; 40 mg/g; mg/g; mg/g; mg/g 10812-227_730d943c-3107-44ac-8135-18d3b21bde10 10812-227 HUMAN OTC DRUG Neutrogena Healthy Skin 3 in 1 Concealer for Eyes Sunscreen Broad Spectrum SPF20 - Medium Titanium Dioxide CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 95 mg/g 10812-228_730d943c-3107-44ac-8135-18d3b21bde10 10812-228 HUMAN OTC DRUG Neutrogena Healthy Skin 3 in 1 Concealer for Eyes Sunscreen Broad Spectrum SPF20 - Light Titanium Dioxide CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 95 mg/g 10812-229_730d943c-3107-44ac-8135-18d3b21bde10 10812-229 HUMAN OTC DRUG Neutrogena Healthy Skin 3 in 1 Concealer for Eyes Sunscreen Broad Spectrum SPF20 - Fair Titanium Dioxide CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 95 mg/g 10812-232_c0f1e043-2b7c-424a-8c96-37dc73246000 10812-232 HUMAN OTC DRUG Neutrogena Oil Free Acne Stress Control Power Foam Wash Salicylic Acid LIQUID TOPICAL 20120329 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 5 mg/mL 10812-233_f6ec7e8e-ed42-4917-989f-ad91f5202b77 10812-233 HUMAN OTC DRUG Neutrogena Oil Free Acne Stress Control 3 in 1 Hydrating Acne Treatment Salicylic Acid LIQUID TOPICAL 20120329 20160601 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-234_96a3c1f9-289b-49b4-900e-ff2a05e02db6 10812-234 HUMAN OTC DRUG Neutrogena Oil Free Acne Stress Control Power Clear Scrub Salicylic Acid LIQUID TOPICAL 20110615 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-236_d4c79831-97d9-4eb0-81db-229984458abd 10812-236 HUMAN OTC DRUG Neutrogena Healthy Skin Glow Sheers Illuminating Tinted Moisturizer - Ivory to Fair 10 Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LIQUID TOPICAL 20130523 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 75; 50; 40; 29 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-237_d4c79831-97d9-4eb0-81db-229984458abd 10812-237 HUMAN OTC DRUG Neutrogena Healthy Skin Glow Sheers Illuminating Tinted Moisturizer - Fair to Light 20 Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LIQUID TOPICAL 20130523 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 75; 50; 40; 29 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-238_d4c79831-97d9-4eb0-81db-229984458abd 10812-238 HUMAN OTC DRUG Neutrogena Healthy Skin Glow Sheers Illuminating Tinted Moisturizer - Light to Medium 30 Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LIQUID TOPICAL 20130523 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 75; 50; 40; 29 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-239_d4c79831-97d9-4eb0-81db-229984458abd 10812-239 HUMAN OTC DRUG Neutrogena Healthy Skin Glow Sheers Illuminating Tinted Moisturizer - Medium to Tan 40 Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LIQUID TOPICAL 20130523 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 75; 50; 40; 29 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-247_67fc6e4d-534b-40c9-8054-42688f465f92 10812-247 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunblock SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20111014 20151017 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-248_997530e0-94d8-4fc4-88c0-3efa3ffafa5b 10812-248 HUMAN OTC DRUG Neutrogena Day Activating SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100401 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-258_9075ef77-f3a1-40ae-b862-ecc58cf8fd2e 10812-258 HUMAN OTC DRUG Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20120504 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 40; 23.5; 50 mg/g; mg/g; mg/g; mg/g; mg/g 10812-259_a047ef8b-936b-4660-bab4-8fdd7914e879 10812-259 HUMAN OTC DRUG Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20120911 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 23.5; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-262_c3d63d40-5161-4dcf-8e2f-248fbfdbd57a 10812-262 HUMAN OTC DRUG Neutrogena Fresh Cooling Sunscreen Body Mist Broad Spectrum SPF70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20121018 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-265_9bb066ac-b77f-4e71-9c7c-f15ad40c8eca 10812-265 HUMAN OTC DRUG Neutrogena Age Shield Anti Oxidant Face Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121019 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-268_58f8e93f-d864-480b-be6d-1f4e2955e406 10812-268 HUMAN OTC DRUG Neutrogena Oil Free Acne Stress Control Salicylic Acid LIQUID TOPICAL 20110418 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-270_f6a98d1a-7b7d-4285-96c2-76e2a8f19c2a 10812-270 HUMAN OTC DRUG Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20120911 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-283_576f511f-b3b9-4104-9bc4-7a95bc1cc2df 10812-283 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF85 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 45; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-285_636024ba-dd50-4b6f-8571-04022d0493cb 10812-285 HUMAN OTC DRUG Neutrogena Oil Free Acne Stress Control Triple Action Toner Salicylic Acid LIQUID TOPICAL 20110602 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-286_13f5f65e-b137-4077-ace5-54ca308d9c80 10812-286 HUMAN OTC DRUG Neutrogena Rapid Clear 2 in 1 Fight and Fade Salicylic Acid LOTION TOPICAL 20111223 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-287_55155328-ba53-4e58-a43e-6e1c2ea309b2 10812-287 HUMAN OTC DRUG Neutrogena Rapid Clear 7 Day Acne Intervention Salicylic Acid KIT 20091215 OTC MONOGRAPH FINAL part333 Neutrogena Corporation 10812-290_ca275cf8-b7a5-4d8b-872b-0c7b9c78b44a 10812-290 HUMAN OTC DRUG Neutrogena MoistureShine Lip Soother Sunscreen SPF20 - Glimmer 15 Octinoxate and Oxybenzone GEL TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 20 mg/g; mg/g 10812-291_ca275cf8-b7a5-4d8b-872b-0c7b9c78b44a 10812-291 HUMAN OTC DRUG Neutrogena MoistureShine Lip Soother Sunscreen SPF20 - Sparkle 45 Octinoxate and Oxybenzone GEL TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 20 mg/g; mg/g 10812-292_ca275cf8-b7a5-4d8b-872b-0c7b9c78b44a 10812-292 HUMAN OTC DRUG Neutrogena MoistureShine Lip Soother Sunscreen SPF20 - Glow 70 Octinoxate and Oxybenzone GEL TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 20 mg/g; mg/g 10812-300_376749e2-f7fe-44d6-a84c-45ea3562db85 10812-300 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Pink Grapefruit Facial Cleanser Salicylic Acid LIQUID TOPICAL 20120329 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-301_fd2b2720-7dd4-4eb0-a72d-41b8483d788b 10812-301 HUMAN OTC DRUG Neutrogena Body Clear Body Wash Pink Grapefruit Salicylic Acid LIQUID TOPICAL 20120321 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-302_1bc7f255-e921-4b4f-84be-c74b897431b0 10812-302 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Pink Grapefruit Foaming Scrub Salicylic Acid LOTION TOPICAL 20120329 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-304_730d943c-3107-44ac-8135-18d3b21bde10 10812-304 HUMAN OTC DRUG Neutrogena Healthy Skin 3 in 1 Concealer for Eyes Sunscreen Broad Spectrum SPF20 - Buff Titanium Dioxide CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 95 mg/g 10812-320_1122a35e-b8b5-43b7-9321-98aed731d648 10812-320 HUMAN OTC DRUG Neutrogena Ultimate Sport Sunblock SPF70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20111212 20160914 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-321_fca28714-1832-4d15-ae10-b25253ba57f5 10812-321 HUMAN OTC DRUG Neutrogena Sport Face Sunblock SPF70plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20111214 20151022 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-322_7a4ccafd-add3-4f35-8ce4-8d39e5b23ed6 10812-322 HUMAN OTC DRUG Neutrogena Pure and free Baby Sunblock SPF 60plus Purescreen Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20101201 20151015 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 49; 47 mg/mL; mg/mL 10812-323_807e3af9-4b32-4b4b-b25d-3942ba347fcf 10812-323 HUMAN OTC DRUG Neutrogena Sensitive Skin Sunblock SPF60 Plus Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20120217 20151022 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 49; 47 mg/mL; mg/mL 10812-324_1bd63e60-21a2-4a57-9a16-d2c43ae0e4a2 10812-324 HUMAN OTC DRUG Neutrogena Pure and Free Baby Sunscreen Broad Spectrum SPF60 Plus Titanium Dioxide and Zinc Oxide STICK TOPICAL 20121022 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 60; 47 mg/g; mg/g 10812-326_c3b4de18-c72f-483b-98d9-93de709034b1 10812-326 HUMAN OTC DRUG Neutrogena Ageless Intensive Anti-Wrinkle Instant Radiance Daily Moisturizer SPF25 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100610 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 40; 50; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-327_db1a2edd-34ba-451c-ad09-ec1337a3e8c5 10812-327 HUMAN OTC DRUG Neutrogena Healthy Defense Daily Moisturizer SPF 50 with Helioplex Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20110301 20160924 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 23.5; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-328_e762cc25-67b1-44dd-8095-a6b2fd295d26 10812-328 HUMAN OTC DRUG Neutrogena Rapid Clear Foaming Scrub Salicylic Acid LOTION TOPICAL 20100601 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-329_9704c8ce-427a-41d8-a41e-22536b5c9e3c 10812-329 HUMAN OTC DRUG Neutrogena Healthy Defense Moisturizer SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LIQUID TOPICAL 20100601 20160901 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 40; 50; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-331_7c6132b6-c91c-471f-8593-128dac981c73 10812-331 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Angels Blush 100 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-332_7c6132b6-c91c-471f-8593-128dac981c73 10812-332 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Think Pink 110 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; ug/g; mg/g 10812-333_7c6132b6-c91c-471f-8593-128dac981c73 10812-333 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Tickled Pink 120 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-334_7c6132b6-c91c-471f-8593-128dac981c73 10812-334 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Anything Rose 200 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-335_7c6132b6-c91c-471f-8593-128dac981c73 10812-335 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Just Whisper 210 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-336_7c6132b6-c91c-471f-8593-128dac981c73 10812-336 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Sheer Luck 220 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-337_7c6132b6-c91c-471f-8593-128dac981c73 10812-337 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Caramel Kiss 230 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-338_7c6132b6-c91c-471f-8593-128dac981c73 10812-338 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Nude Blush 240 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-339_7c6132b6-c91c-471f-8593-128dac981c73 10812-339 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Rum Raisin 250 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-340_7c6132b6-c91c-471f-8593-128dac981c73 10812-340 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Pinch of Cinn 260 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-341_7c6132b6-c91c-471f-8593-128dac981c73 10812-341 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Mauve On 300 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-342_7c6132b6-c91c-471f-8593-128dac981c73 10812-342 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Playful Plum 310 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-343_7c6132b6-c91c-471f-8593-128dac981c73 10812-343 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Plum Paradise 320 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-344_7c6132b6-c91c-471f-8593-128dac981c73 10812-344 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Berry Burst 400 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-345_7c6132b6-c91c-471f-8593-128dac981c73 10812-345 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Cherry Twist 410 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-346_7c6132b6-c91c-471f-8593-128dac981c73 10812-346 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Poppy Red 420 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-347_7c6132b6-c91c-471f-8593-128dac981c73 10812-347 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Pomegranite 430 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-348_7c6132b6-c91c-471f-8593-128dac981c73 10812-348 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Electric Currant 440 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-349_7c6132b6-c91c-471f-8593-128dac981c73 10812-349 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Coral Dream 500 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-350_7c6132b6-c91c-471f-8593-128dac981c73 10812-350 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Peach-A-Boo 510 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g 10812-351_31a54786-0ad5-4be0-83bc-4c881ac1acd7 10812-351 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Classic Ivory 10 Salicylic Acid LIQUID TOPICAL 20100325 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5 mg/mL 10812-352_31a54786-0ad5-4be0-83bc-4c881ac1acd7 10812-352 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Natural Ivory 20 Salicylic Acid LIQUID TOPICAL 20100325 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5 mg/mL 10812-353_9daa27a0-2ef8-4112-81df-d9e75e3671b9 10812-353 HUMAN OTC DRUG Neutrogena Age Shield Face SPF 110 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100601 20151016 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-354_31a54786-0ad5-4be0-83bc-4c881ac1acd7 10812-354 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Nude 40 Salicylic Acid LIQUID TOPICAL 20100325 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5 mg/mL 10812-355_31a54786-0ad5-4be0-83bc-4c881ac1acd7 10812-355 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Soft Beige 50 Salicylic Acid LIQUID TOPICAL 20100325 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5 mg/mL 10812-356_31a54786-0ad5-4be0-83bc-4c881ac1acd7 10812-356 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Fresh Beige 70 Salicylic Acid LIQUID TOPICAL 20100325 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5 mg/mL 10812-357_31a54786-0ad5-4be0-83bc-4c881ac1acd7 10812-357 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Medium Beige 80 Salicylic Acid LIQUID TOPICAL 20100325 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5 mg/mL 10812-358_31a54786-0ad5-4be0-83bc-4c881ac1acd7 10812-358 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Warm Beige 90 Salicylic Acid LIQUID TOPICAL 20100325 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5 mg/mL 10812-359_31a54786-0ad5-4be0-83bc-4c881ac1acd7 10812-359 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Natural Tan 100 Salicylic Acid LIQUID TOPICAL 20100325 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5 mg/mL 10812-360_31a54786-0ad5-4be0-83bc-4c881ac1acd7 10812-360 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Tan 120 Salicylic Acid LIQUID TOPICAL 20100325 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5 mg/mL 10812-361_31a54786-0ad5-4be0-83bc-4c881ac1acd7 10812-361 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Natural Beige 60 Salicylic Acid LIQUID TOPICAL 20100325 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5 mg/mL 10812-362_31a54786-0ad5-4be0-83bc-4c881ac1acd7 10812-362 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Honey Beige 110 Salicylic Acid LIQUID TOPICAL 20100325 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5 mg/mL 10812-364_8dbc346b-26ed-4304-9db0-6f2022e2fe15 10812-364 HUMAN OTC DRUG Neutrogena Rapid Clear On-the-Go Acne Treatment Pen Salicylic Acid GEL TOPICAL 20100601 20150101 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/g 10812-365_31a54786-0ad5-4be0-83bc-4c881ac1acd7 10812-365 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Buff 30 Salicylic Acid LIQUID TOPICAL 20100325 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5 mg/mL 10812-366_b49d814c-f3ff-41bb-919c-83399bd2b973 10812-366 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF100 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-367_cabbdca9-d389-417f-8d2e-9f297ee7b84f 10812-367 HUMAN OTC DRUG Neutrogena Men Sensitive Skin Oil Free Moisture Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121015 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-368_34c56ffa-eba6-441d-8aca-9cd0bc8389aa 10812-368 HUMAN OTC DRUG Neutrogena Ultimate Sport Sunblock SPF 100 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20100110 20160913 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-370_1d0eafb9-1b55-4b7f-969c-9ca77566d994 10812-370 HUMAN OTC DRUG Neutrogena Ultra Sheer Daily Sun Protection SPF55 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LIQUID TOPICAL 20101115 20150101 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 75; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-371_a832b0da-6ffb-463d-aa1d-ea9d255fbcfb 10812-371 HUMAN OTC DRUG Neutrogena Ultimate Sport Sunblock SPF 70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20110107 20160912 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-372_ff89a60e-92de-454c-82ce-a1ce3168deb5 10812-372 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunblock SPF 30 Helioplex Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20110415 20160920 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 40; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-378_44229b78-7438-42ed-ae72-25837d1ad91f 10812-378 HUMAN OTC DRUG Neutrogena Ultra Gentle Soothing SPF15 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20110501 20160921 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL 10812-379_a4dc5c58-69aa-4949-8a29-2689198add79 10812-379 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Pink Grapefruit Cleanser Salicylic Acid LIQUID TOPICAL 20110401 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-380_6f2850c1-eba8-4c37-bbfd-207f2bf37e76 10812-380 HUMAN OTC DRUG Neutrogena Rapid Tone Repair Sunscreen SPF30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL 10812-381_074fd19d-698b-4b21-9346-e307972046ff 10812-381 HUMAN OTC DRUG Neutrogena Mineral Sheers SPF20 - Classic Ivory 10 Titanium Dioxide POWDER TOPICAL 20110620 20160801 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 75 mg/g 10812-382_074fd19d-698b-4b21-9346-e307972046ff 10812-382 HUMAN OTC DRUG Neutrogena Mineral Sheers SPF20 - Natural Ivory 20 Titanium Dioxide POWDER TOPICAL 20110620 20160801 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 75 mg/g 10812-383_074fd19d-698b-4b21-9346-e307972046ff 10812-383 HUMAN OTC DRUG Neutrogena Mineral Sheers SPF20 - Buff 30 Titanium Dioxide POWDER TOPICAL 20110620 20160801 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 75 mg/g 10812-384_074fd19d-698b-4b21-9346-e307972046ff 10812-384 HUMAN OTC DRUG Neutrogena Mineral Sheers SPF20 - Nude 40 Titanium Dioxide POWDER TOPICAL 20110620 20160801 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 75 mg/g 10812-385_074fd19d-698b-4b21-9346-e307972046ff 10812-385 HUMAN OTC DRUG Neutrogena Mineral Sheers SPF20 - Soft Beige 50 Titanium Dioxide POWDER TOPICAL 20110620 20160801 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 75 mg/g 10812-386_074fd19d-698b-4b21-9346-e307972046ff 10812-386 HUMAN OTC DRUG Neutrogena Mineral Sheers SPF20 - Natural Beige 60 Titanium Dioxide POWDER TOPICAL 20110620 20160801 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 75 mg/g 10812-387_074fd19d-698b-4b21-9346-e307972046ff 10812-387 HUMAN OTC DRUG Neutrogena Mineral Sheers SPF20 - Honey Beige 70 Titanium Dioxide POWDER TOPICAL 20110620 20160801 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 75 mg/g 10812-388_074fd19d-698b-4b21-9346-e307972046ff 10812-388 HUMAN OTC DRUG Neutrogena Mineral Sheers SPF20 - Tan 80 Titanium Dioxide POWDER TOPICAL 20110620 20160801 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 75 mg/g 10812-390_43464e8e-37a0-441e-b9c2-00b860901937 10812-390 HUMAN OTC DRUG Neutrogena Blackhead Eliminating Cleanser Mask Salicylic Acid LOTION TOPICAL 20111001 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-392_e06d91d0-2bc3-4da8-ad73-9c51cc0d1e54 10812-392 HUMAN OTC DRUG Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 100 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20120911 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-395_6f365442-31d0-4201-9adb-2043f8ed4166 10812-395 HUMAN OTC DRUG Neutrogena Complete Acne Therapy Solution Salicylic Acid, Octinoxate, Zinc Oxide, and Benzoyl Peroxide KIT 20140314 OTC MONOGRAPH FINAL part333D Neutrogena Corporation 10812-396_7201f2cb-225b-444a-836c-4fabfd5f4eee 10812-396 HUMAN OTC DRUG Neutrogena Oil Free Moisture Clear Skin Salicylic Acid LOTION TOPICAL 20111018 20150201 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 5 mg/mL 10812-397_7b332750-053e-490e-9a93-48f17a5d4a19 10812-397 HUMAN OTC DRUG Neutrogena Complete Acne Therapy System Salicylic Acid, Octinoxate, Zinc Oxide, and Benzoyl Peroxide KIT 20120523 20160315 OTC MONOGRAPH FINAL part333D Neutrogena Corporation 10812-398_5c976842-06c7-406f-9cae-1ba2fe198731 10812-398 HUMAN OTC DRUG Neutrogena All in 1 Acne Control Daily Scrub Salicylic Acid LIQUID TOPICAL 20111130 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-399_f7d4567f-685e-4abe-8f87-ce962759a493 10812-399 HUMAN OTC DRUG Neutrogena Pure and Free Baby Faces Ultra Gentle Sunblock SPF 50plus Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20111018 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 51; 29 mg/mL; mg/mL 10812-400_e02e7c04-a83d-42eb-982e-2159e43e06e3 10812-400 HUMAN OTC DRUG Neutrogena Rapid Wrinkle Repair Moisturizer SPF 30 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20101201 20160801 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL 10812-401_657805ca-2953-41fb-b3ba-7b161a048585 10812-401 HUMAN OTC DRUG Neutrogena Healthy Skin Firms and Lifts SPF15 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101201 20160801 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-402_0077ce8f-0999-4d8a-bb79-d2e0f7e003a4 10812-402 HUMAN OTC DRUG Neutrogena Healthy Skin Radiance Boosts Radiance SPF15 Avobenzone, Octinoxate, and Octisalate CREAM TOPICAL 20101201 20160801 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL 10812-404_21eb0fdd-5190-4fd2-a741-6eef1fda30b7 10812-404 HUMAN OTC DRUG Neutrogena Clear Pore Daily Scrub Benzoyl Peroxide CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333D Neutrogena Corporation BENZOYL PEROXIDE 37 mg/mL 10812-405_7f257958-b7d1-4aaf-bbac-b63419a8673c 10812-405 HUMAN OTC DRUG Neutrogena Pure and Free Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20101201 20151016 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 50; 30 mg/mL; mg/mL 10812-406_3de1b6ae-7317-4b52-8a60-4bd59ae67b71 10812-406 HUMAN OTC DRUG Neutrogena Spectrum plus Advanced Sunblock SPF 100 plus helioplex 360 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20101201 20151022 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-407_ab821eef-18c2-419f-b72c-8338db47eee7 10812-407 HUMAN OTC DRUG Neutrogena T/Gel Therapeutic Salicylic Acid KIT 20101201 20150601 OTC MONOGRAPH FINAL part358H Neutrogena Corporation 10812-408_06483677-dfac-458a-95f3-5e0ae5628557 10812-408 HUMAN OTC DRUG Neutrogena Men Active protect Face SPF 50 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20101201 20160701 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-409_49097fe7-c611-492b-8ed8-711bf6b56196 10812-409 HUMAN OTC DRUG Neutrogena Ultimate Sport Sunblock SPF 30 Helioplex Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20101201 20160914 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-413_7b80cc32-b172-4a63-a210-28ae925dc716 10812-413 HUMAN OTC DRUG Neutrogena Ageless Intensives Tone Correcting Tinted Daily Moisturizer SPF 30 Helioplex Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20101201 20150102 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 40; 50; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-415_7527dd9e-30bd-497a-ab9b-a3552252d646 10812-415 HUMAN OTC DRUG Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20120605 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-416_7286d20d-e497-4533-bcd3-712e632d797c 10812-416 HUMAN OTC DRUG Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 45; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-417_f91c9739-df83-48a2-af6b-b5a0f611a296 10812-417 HUMAN OTC DRUG Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 30; 40; 20; 50 mg/g; mg/g; mg/g; mg/g; mg/g 10812-418_aff38b06-985e-4a8d-a395-276bd38a7f90 10812-418 HUMAN OTC DRUG Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27; 80; 50; 35; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-419_69afd897-fa08-48b9-bf46-b0e27bd98e76 10812-419 HUMAN OTC DRUG Neutrogena Ultra sheer Face and Body Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130905 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 30 mg/g; mg/g; mg/g; mg/g; mg/g 10812-420_47ddb5cd-9d9f-4699-b332-2255f1d5d70e 10812-420 HUMAN OTC DRUG Neutrogena Pure and Free Baby Faces Ultra Gentle Sunscreen Broad Spectrum SPF45 Plus Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 51; 29 mg/mL; mg/mL 10812-421_5e801b3f-30c4-46f5-bcda-535f7a022226 10812-421 HUMAN OTC DRUG Neutrogena Rapid Wrinkle Repair Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL 10812-422_ed831a31-3565-4f74-8362-b604e1c552e2 10812-422 HUMAN OTC DRUG Neutrogena Healthy Skin Firming Sunscreen Broad Spectrum SPF15 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-423_d95f17f3-1226-45f4-828c-4e22281f8394 10812-423 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF55 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-424_20cc1598-10ea-49c2-8dfc-1abca1552a24 10812-424 HUMAN OTC DRUG Neutrogena Healthy Skin Radiance Sunscreen Broad Spectrum SPF15 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20120802 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL 10812-425_5c93f010-9df2-4e47-8b88-d0a2e063933b 10812-425 HUMAN OTC DRUG Neurogena Healthy Defense Moisturizer Sunscreen Broad Spectrum SPF50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LIQUID TOPICAL 20120828 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 40; 50; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-426_49e79e58-0a7e-41d0-a9d6-795c9afe698e 10812-426 HUMAN OTC DRUG Neutrogena Ageless Intensives Anti Wrinkle Deep Wrinkle Daily Moisturizer Sunscreen Broad Spectrum SPF20 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20121019 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 70; 40; 15; 20 mg/g; mg/g; mg/g; mg/g; mg/g 10812-427_890b8ff9-5400-4430-a1bf-517227ad8466 10812-427 HUMAN OTC DRUG Neutrogena Age Shield Face Oil Free Sunscreen Broad Spectrum SPF110 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121016 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-428_51e2a471-6305-4565-b470-739d3c45fc1c 10812-428 HUMAN OTC DRUG Neutrogena Clear Face Break Out Free Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121019 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25; 50; 40; 30; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-429_b3b95d73-2cba-406c-b24b-6d032d0b4981 10812-429 HUMAN OTC DRUG Neutrogena Clear Face Break Out Free Sunscreen Broad Spectrum SPF55 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LIQUID TOPICAL 20121019 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27; 40; 45; 60; 45 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-430_2dae76eb-d88c-46bd-b4f9-6e00eeeee431 10812-430 HUMAN OTC DRUG Neutrogena Pure and Free Sunscreen Broad Spectrum SPF50 Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20121016 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 50; 30 mg/mL; mg/mL 10812-431_c26773a5-80b6-4280-a61f-152a1d4017d8 10812-431 HUMAN OTC DRUG Neutrogena Pure and Free Baby Sunscreen Broad Spectrum SPF60 Plus Purescreen Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20121017 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 49; 47 mg/mL; mg/mL 10812-432_f10d2b7e-bcbb-4972-93a4-533694ce7402 10812-432 HUMAN OTC DRUG Neutrogena Spectrum Plus Advanced Sunscreen Broad Spectrum SPF100 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20121022 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-433_6e6b4c9f-4386-4417-b1dd-4ea0f49fec3e 10812-433 HUMAN OTC DRUG Neutrogena Sport Face Oil Free Sunscreen Broad Spectrum SPF70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121022 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-434_ae4929e6-00cd-4c5d-bb8a-97e291cb0926 10812-434 HUMAN OTC DRUG Neutrogena Sensitive Skin Sunscreen Broad Spectrum SPF60 Plus Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20121022 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 49; 47 mg/mL; mg/mL 10812-435_e1329ece-96a7-43fb-923b-5c988b4a66a8 10812-435 HUMAN OTC DRUG Neutrogena Nourishing Long Wear Makeup Tone Correcting Complex Sunscreen Broad Spectrum SPF20 Classic Ivory10 Titanium Dioxide LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 29 mg/mL 10812-436_e1329ece-96a7-43fb-923b-5c988b4a66a8 10812-436 HUMAN OTC DRUG Neutrogena Nourishing Long Wear Makeup Tone Correcting Complex Sunscreen Broad Spectrum SPF20 Natural Ivory20 Titanium Dioxide LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 29 mg/mL 10812-437_e1329ece-96a7-43fb-923b-5c988b4a66a8 10812-437 HUMAN OTC DRUG Neutrogena Nourishing Long Wear Makeup Tone Correcting Complex Sunscreen Broad Spectrum SPF20 Buff30 Titanium Dioxide LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 29 mg/mL 10812-438_e1329ece-96a7-43fb-923b-5c988b4a66a8 10812-438 HUMAN OTC DRUG Neutrogena Nourishing Long Wear Makeup Tone Correcting Complex Sunscreen Broad Spectrum SPF20 Nude40 Titanium Dioxide LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 29 mg/mL 10812-439_e1329ece-96a7-43fb-923b-5c988b4a66a8 10812-439 HUMAN OTC DRUG Neutrogena Nourishing Long Wear Makeup Tone Correcting Complex Sunscreen Broad Spectrum SPF20 Soft Beige50 Titanium Dioxide LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 29 mg/mL 10812-440_e1329ece-96a7-43fb-923b-5c988b4a66a8 10812-440 HUMAN OTC DRUG Neutrogena Nourishing Long Wear Makeup Tone Correcting Complex Sunscreen Broad Spectrum SPF20 Natural Beige60 Titanium Dioxide LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 29 mg/mL 10812-441_e1329ece-96a7-43fb-923b-5c988b4a66a8 10812-441 HUMAN OTC DRUG Neutrogena Nourishing Long Wear Makeup Tone Correcting Complex Sunscreen Broad Spectrum SPF20 Fresh Beige70 Titanium Dioxide LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 29 mg/mL 10812-442_e1329ece-96a7-43fb-923b-5c988b4a66a8 10812-442 HUMAN OTC DRUG Neutrogena Nourishing Long Wear Makeup Tone Correcting Complex Sunscreen Broad Spectrum SPF20 Warm Beige80 Titanium Dioxide LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 29 mg/mL 10812-443_a7d97a45-cda4-40df-a70c-c9b8e9bb8a27 10812-443 HUMAN OTC DRUG Neutrogena Pure and Free Baby Sunscreen Broad Spectrum SPF60 Plus Titanium Dioxide and Zinc Oxide STICK TOPICAL 20130103 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 80; 68 mg/g; mg/g 10812-445_3fb0a018-b8d7-4349-a28b-d765c50fe96c 10812-445 HUMAN OTC DRUG Neutrogena Beach Defense Sunscreen Broad Spectrum SPF50 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone STICK TOPICAL 20130913 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 30 mg/g; mg/g; mg/g; mg/g; mg/g 10812-448_a12dde42-f25d-4c00-9eb2-455a5c895787 10812-448 HUMAN OTC DRUG Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-449_88f653a6-22fe-48f7-890c-28da7ff2d256 10812-449 HUMAN OTC DRUG Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 40; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-450_ee45756a-4e36-4bfb-a844-74ab1e30ea83 10812-450 HUMAN OTC DRUG Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-451_f76b3660-3a2e-475e-9844-17f96c00dff8 10812-451 HUMAN OTC DRUG Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g 10812-456_cb4b0c2b-c311-431f-9b26-d60dcd853490 10812-456 HUMAN OTC DRUG Neutrogena Healthy Skin Brightening Eye Perfector Sunscreen Broad Spectrum SPF25 - Fair 05 Titanium Dioxide CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 18.8 mg/g 10812-457_cb4b0c2b-c311-431f-9b26-d60dcd853490 10812-457 HUMAN OTC DRUG Neutrogena Healthy Skin Brightening Eye Perfector Sunscreen Broad Spectrum SPF25 - Light 10 Titanium Dioxide CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 18.8 mg/g 10812-458_cb4b0c2b-c311-431f-9b26-d60dcd853490 10812-458 HUMAN OTC DRUG Neutrogena Healthy Skin Brightening Eye Perfector Sunscreen Broad Spectrum SPF25 - Medium 15 Titanium Dioxide CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 18.8 mg/g 10812-459_cb4b0c2b-c311-431f-9b26-d60dcd853490 10812-459 HUMAN OTC DRUG Neutrogena Healthy Skin Brightening Eye Perfector Sunscreen Broad Spectrum SPF25 - Buff 09 Titanium Dioxide CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 18.8 mg/g 10812-503_05c45655-25e3-40ff-b8e2-60b439cb8167 10812-503 HUMAN OTC DRUG Neutrogena Ageless Essentials Continuous Hydration Daily Moisturizer SPF25 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 20; 40; 18; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-505_53aa90aa-8402-47a1-abe9-b808b42ed413 10812-505 HUMAN OTC DRUG Neutrogena TGel Therapeutic Stubborn Itch Coal Tar SHAMPOO TOPICAL 20120330 OTC MONOGRAPH FINAL part358H Neutrogena Corporation COAL TAR 5 mg/mL 10812-506_23274506-fc35-48f3-9cdb-8c87bb48acec 10812-506 HUMAN OTC DRUG Neutrogena Skin Clearing Salicylic Acid POWDER TOPICAL 20091130 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 3.9 mg/g 10812-507_aa247493-7e04-4043-93f4-c31e3b1aef86 10812-507 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunblock SPF 45 with helioplex Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20110602 20151015 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-508_07746a50-f105-40cc-aa28-64c223a753b6 10812-508 HUMAN OTC DRUG Neutrogena Skin Clearing Salicylic Acid POWDER TOPICAL 20091130 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 3.9 mg/g 10812-509_a96e9299-6e54-4c0e-bf2e-295badb715f3 10812-509 HUMAN OTC DRUG Neutrogena Skin Clearing Salicylic Acid POWDER TOPICAL 20091130 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 3.9 mg/g 10812-510_6c7c1b72-c380-47b6-8f60-091851e09ed6 10812-510 HUMAN OTC DRUG Neutrogena Skin Clearing Salicylic Acid POWDER TOPICAL 20091130 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 3.9 mg/g 10812-511_f2267976-75b7-4054-8163-8d4853d5c4cb 10812-511 HUMAN OTC DRUG Neutrogena Skin Clearing Salicylic Acid POWDER TOPICAL 20091130 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 3.9 mg/g 10812-512_1d41e146-1eee-4408-b62a-5f12971845aa 10812-512 HUMAN OTC DRUG Neutrogena Skin Clearing Salicylic Acid POWDER TOPICAL 20091130 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 3.9 mg/g 10812-513_d51ae5a2-271f-452b-baa3-9dd1dc9ffbb8 10812-513 HUMAN OTC DRUG Neutrogena Skin Clearing Salicylic Acid POWDER TOPICAL 20091130 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 3.9 mg/g 10812-514_63ed3a4c-433c-4b95-81a4-4a85af33cffc 10812-514 HUMAN OTC DRUG Neutrogena Skin Clearing Salicylic Acid POWDER TOPICAL 20091130 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 3.9 mg/g 10812-519_ff21ed83-5f0a-4f69-9477-84bc3dab4f65 10812-519 HUMAN OTC DRUG Neutrogena Skin Clearing Blemish Concealer - Fair 05 Salicylic Acid CREAM TOPICAL 20100205 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5.5 mg/g 10812-520_ff21ed83-5f0a-4f69-9477-84bc3dab4f65 10812-520 HUMAN OTC DRUG Neutrogena Skin Clearing Blemish Concealer - Buff 09 Salicylic Acid CREAM TOPICAL 20100205 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5.5 mg/g 10812-521_ff21ed83-5f0a-4f69-9477-84bc3dab4f65 10812-521 HUMAN OTC DRUG Neutrogena Skin Clearing Blemish Concealer - Light 10 Salicylic Acid CREAM TOPICAL 20100205 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5.5 mg/g 10812-522_ff21ed83-5f0a-4f69-9477-84bc3dab4f65 10812-522 HUMAN OTC DRUG Neutrogena Skin Clearing Blemish Concealer - Medium 15 Salicylic Acid CREAM TOPICAL 20100205 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5.5 mg/g 10812-523_df00f3fd-2181-416e-89c9-05a3babfe74c 10812-523 HUMAN OTC DRUG Neutrogena Ultimate Sport Sunscreen Broad Spectrum SPF70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20120912 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-524_8b8e430f-58c7-4725-86b3-3f890ff15cba 10812-524 HUMAN OTC DRUG Neutrogena Ultimate Sport Sunscreen Broad Spectrum SPF100 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20120912 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-525_d1a43a74-960f-4dda-a293-11dfae92d3dc 10812-525 HUMAN OTC DRUG Neutrogena Wet Skin Swim Humidity Sweat Sunscreen Broad Spectrum SFP45 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120919 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 40; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-526_4bec2c13-4789-444b-9075-282e8b79545e 10812-526 HUMAN OTC DRUG Neutrogena Ultimate Sport Sunscreen Broad Spectrum SPF70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120914 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-527_a90ac338-0ccd-48e2-84e3-621ae53c7741 10812-527 HUMAN OTC DRUG Neutrogena Ultimate Sport Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120914 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-528_b704d1fd-6b54-43e8-8706-f9cf3df387d8 10812-528 HUMAN OTC DRUG Neutrogena Wet Skin Kids Beach and Pool Sunscreen Broad Spectrum SPF45 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120919 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 40; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-529_ff1acafc-ab3d-4479-97d5-33d64aab6f58 10812-529 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120920 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 40; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-531_a9bcc179-e5ef-44ef-bd47-fd079a1e8302 10812-531 HUMAN OTC DRUG Neutrogena Ultra Gentle Soothing Sunscreen Broad Spectrum SPF15 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20120921 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL 10812-532_66726a7a-4521-42b0-a892-c965d8f0635e 10812-532 HUMAN OTC DRUG Neutrogena Healthy Defense Daily Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 23.5; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-534_cc4b10a6-9f79-441c-ac1b-0c537040abb5 10812-534 HUMAN OTC DRUG Neutrogena Healthy Defense Daily Moisturizer Sunscreen Broad Spectrum SPF50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 23.5; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-535_0a3d10d9-b14d-4c10-9752-70f34805d395 10812-535 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF45 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-536_e216de08-c4bf-4e6e-a122-6a79037182a1 10812-536 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121017 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-537_130b0ad9-1a99-4b30-be78-237e52e86536 10812-537 HUMAN OTC DRUG Neutrogena Triple Age Repair Moisturizer Broad Spectrum SPF25 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/g; mg/g; mg/g; mg/g 10812-600_884674a1-1a49-4381-831a-025ee6ce76fd 10812-600 HUMAN OTC DRUG Neutrogena Shine Control Makeup Broad Spectrum SPF20 - Classic Ivory 10 Titanium Dioxide LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 32 mg/mL 10812-601_884674a1-1a49-4381-831a-025ee6ce76fd 10812-601 HUMAN OTC DRUG Neutrogena Shine Control Makeup Broad Spectrum SPF20 - Natural Ivory 20 Titanium Dioxide LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 32 mg/mL 10812-602_884674a1-1a49-4381-831a-025ee6ce76fd 10812-602 HUMAN OTC DRUG Neutrogena Shine Control Makeup Broad Spectrum SPF20 - Buff 30 Titanium Dioxide LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 32 mg/mL 10812-603_884674a1-1a49-4381-831a-025ee6ce76fd 10812-603 HUMAN OTC DRUG Neutrogena Shine Control Makeup Broad Spectrum SPF20 - Nude 40 Titanium Dioxide LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 32 mg/mL 10812-604_884674a1-1a49-4381-831a-025ee6ce76fd 10812-604 HUMAN OTC DRUG Neutrogena Shine Control Makeup Broad Spectrum SPF20 - Soft Beige 50 Titanium Dioxide LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 32 mg/mL 10812-605_884674a1-1a49-4381-831a-025ee6ce76fd 10812-605 HUMAN OTC DRUG Neutrogena Shine Control Makeup Broad Spectrum SPF20 - Natural Beige 60 Titanium Dioxide LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 32 mg/mL 10812-606_884674a1-1a49-4381-831a-025ee6ce76fd 10812-606 HUMAN OTC DRUG Neutrogena Shine Control Makeup Broad Spectrum SPF20 - Fresh Beige 70 Titanium Dioxide LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 32 mg/mL 10812-607_884674a1-1a49-4381-831a-025ee6ce76fd 10812-607 HUMAN OTC DRUG Neutrogena Shine Control Makeup Broad Spectrum SPF20 - Warm Beige 90 Titanium Dioxide LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 32 mg/mL 10812-608_9c63214b-0536-49a5-9fbf-b39f3dbf2731 10812-608 HUMAN OTC DRUG Neutrogena Healthy Skin Primer Broad Spectrum SPF15 Avobenzone, Homosalate, and Octinoxate LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTINOXATE 20; 30; 40 mg/mL; mg/mL; mg/mL 10812-611_e4965ed8-c265-43ab-983e-52ed0f4280a8 10812-611 HUMAN OTC DRUG Neutrogena Wet Skin Swim Humidity Sweat Sunscreen Broad Spectrum SPF50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 100; 50 mg/g; mg/g; mg/g; mg/g; mg/g 10812-612_4073f444-1bc8-49aa-a060-975f511d9828 10812-612 HUMAN OTC DRUG Neutrogena Wet Skin Kids Beach and Pool Sunscreen Broad Spectrum SPF70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone STICK TOPICAL 20120908 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 30 mg/g; mg/g; mg/g; mg/g; mg/g 10812-701_d7311d7b-d2a1-4042-a32d-bcbf927da3a1 10812-701 HUMAN OTC DRUG Neutrogena Wet Skin Kids Beach and Pool Sunscreen Broad Spectrum SPF70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20120816 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-702_9e9797f8-6120-4894-b840-47e5b8239b59 10812-702 HUMAN OTC DRUG Neutrogena Wet Skin Swim Humidity Sweat Sunscreen Broad Spectrum SPF85 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20120816 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-812_fa5308d3-2d22-44fd-81aa-118733ce6ea7 10812-812 HUMAN OTC DRUG Neutrogena Anti-Wrinkle Deep Wrinkle Daily Moisturizer SPF 20 helioplex Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100623 20151019 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 70; 40; 15; 20 mg/g; mg/g; mg/g; mg/g; mg/g 10812-814_8e46509e-34b8-4e3c-a6ec-df5a18019429 10812-814 HUMAN OTC DRUG Neutrogena Ageless Intensives Tone Correcting Daily Moisturizer Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130827 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 40; 50; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-818_fc9f885c-7e5b-4c80-b0d5-4a0dccb6014f 10812-818 HUMAN OTC DRUG Neutrogena Ageless Restoratives Anti-Oxidant Daily Moisturizer SPF 20 Helioplex Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 18; 70; 40; 15; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-819_a6e097df-7a98-49f8-a7f2-a5ab804f274f 10812-819 HUMAN OTC DRUG Neutrogena Oil-Free Acne Wash Clear Skin Wipes Salicylic Acid CLOTH TOPICAL 20100601 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 5 mg/1 10812-836_1eaf6e8a-6c42-4318-a30f-3a39268425e2 10812-836 HUMAN OTC DRUG Neutrogena Nourishing Eye Quad SPF 15 - Blue Smoke 150 Titanium Dioxide POWDER TOPICAL 20100329 20151201 OTC MONOGRAPH FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 41.1 mg/g 10812-837_1eaf6e8a-6c42-4318-a30f-3a39268425e2 10812-837 HUMAN OTC DRUG Neutrogena Nourishing Eye Quad SPF15 - Copper Glow 130 Titanium Dioxide POWDER TOPICAL 20100329 20151201 OTC MONOGRAPH FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 41.1 mg/g 10812-838_1eaf6e8a-6c42-4318-a30f-3a39268425e2 10812-838 HUMAN OTC DRUG Neutrogena Nourishing Eye Quad SPR 15 - Garden Party 160 Titanium Dioxide POWDER TOPICAL 20100329 20151201 OTC MONOGRAPH FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 41.1 mg/g 10812-839_1eaf6e8a-6c42-4318-a30f-3a39268425e2 10812-839 HUMAN OTC DRUG Neutrogena Nourishing Eye Quad SPF15 - Moonlit Violet 170 Titanium Dioxide POWDER TOPICAL 20100329 20151201 OTC MONOGRAPH FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 41.1 mg/g 10812-840_1eaf6e8a-6c42-4318-a30f-3a39268425e2 10812-840 HUMAN OTC DRUG Neutrogena Nourishing Eye Quad SPF15 - Sea Shell 140 Titanium Dioxide POWDER TOPICAL 20100329 20151201 OTC MONOGRAPH FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 41.1 mg/g 10812-841_1eaf6e8a-6c42-4318-a30f-3a39268425e2 10812-841 HUMAN OTC DRUG Neutrogena Nourishing Eye Quad SPF 15 - Tea Biscuit 120 Titanium Dioxide POWDER TOPICAL 20100329 20151201 OTC MONOGRAPH FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 41.1 mg/g 10812-842_1eaf6e8a-6c42-4318-a30f-3a39268425e2 10812-842 HUMAN OTC DRUG Neutrogena Nourishing Eye Quad SPF15 Vintage Wine 180 Titanium Dioxide POWDER TOPICAL 20100329 20151201 OTC MONOGRAPH FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 41.1 mg/g 10812-847_068dedfd-6744-4d3a-a6a9-a987f17d0057 10812-847 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Redness Soothing Cream Cleanser Salicylic Acid LOTION TOPICAL 20120329 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-848_d4e03234-988a-4bd5-9c90-90bd001b54ae 10812-848 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Redness Soothing Facial Cleanser Salicylic Acid LIQUID TOPICAL 20120330 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-849_5207e5d4-3f35-4c8f-a7d9-9deabc710aef 10812-849 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Redness Soothing Gentle Scrub Salicylic Acid LIQUID TOPICAL 20121019 20160101 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-863_1eaf6e8a-6c42-4318-a30f-3a39268425e2 10812-863 HUMAN OTC DRUG Neutrogena Nourishing Eye Quad SPF 15 - Butter Creme 110 Titanium Dioxide POWDER TOPICAL 20100329 20151201 OTC MONOGRAPH FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 41.1 mg/g 10812-869_2275d4a6-6f05-4459-a4b4-ffc715529358 10812-869 HUMAN OTC DRUG Neutrogena Oil Free Acne Stress Control Night Cleansing Pads Salicylic Acid CLOTH TOPICAL 20110927 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/1 10812-872_3ba65efc-d155-40f4-b8d3-18ef90dca42f 10812-872 HUMAN OTC DRUG Neutrogena Wet Skin Swim Humidity Sweat Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20100112 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 40; 80; 50 mg/g; mg/g; mg/g; mg/g; mg/g 10812-873_fd9627c4-b747-494c-9a2a-5b2a7b68dcc5 10812-873 HUMAN OTC DRUG Neutrogena Ultra Sheer Sunscreen Broad Spectrum SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LIQUID TOPICAL 20120823 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 75; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-874_9f2708f9-b29e-44f7-b286-7d3e83e803d8 10812-874 HUMAN OTC DRUG Neutrogena Norwegian Formula Lip Moisturizer SPF15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131017 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 40 mg/g; mg/g 10812-875_dfdf90c4-8130-4320-b1b3-ef2e5750dc31 10812-875 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Nude 40 Titanium Dioxide LIQUID TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 66 mg/mL 10812-876_dfdf90c4-8130-4320-b1b3-ef2e5750dc31 10812-876 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Soft Beige 50 Titanium Dioxide LIQUID TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 66 mg/mL 10812-900_93668823-728f-489a-8a05-fbb2d062d848 10812-900 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Salicylic Acid CREAM TOPICAL 20110215 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-907_8b96a077-fd9a-4c8c-b536-1aefba489a87 10812-907 HUMAN OTC DRUG Neutrogena Intensified Day Moisture SPF15 Ensulizole and Octinoxate CREAM TOPICAL 20100601 20150101 OTC MONOGRAPH FINAL part352 Neutrogena Corporation ENSULIZOLE; OCTINOXATE 10; 75 mg/g; mg/g 10812-913_3ba8de46-a489-476c-8485-74a2088b3aa3 10812-913 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Salicylic Acid GEL TOPICAL 20130212 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-914_e193dd2a-2998-431b-80ac-cc4565442719 10812-914 HUMAN OTC DRUG Neutrogena On-the-Spot Acne Treatment Vanishing Formula Benzoyl Peroxide CREAM TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333D Neutrogena Corporation BENZOYL PEROXIDE 2.5 mg/g 10812-916_8bc13818-d7eb-41e0-aef4-e52cc25df86d 10812-916 HUMAN OTC DRUG Neutrogena T/Sal Therapeutic Salicylic Acid SHAMPOO TOPICAL 20111012 OTC MONOGRAPH FINAL part358H Neutrogena Corporation SALICYLIC ACID 30 mg/mL 10812-920_0c4fb70b-c5ec-4657-acce-394ef493c0a8 10812-920 HUMAN OTC DRUG Neutrogena TGel Therapeutic Coal Tar SHAMPOO TOPICAL 20120330 OTC MONOGRAPH FINAL part358H Neutrogena Corporation COAL TAR 5 mg/mL 10812-925_c7271e84-ea33-48ed-89ac-14012d6eac7d 10812-925 HUMAN OTC DRUG Neutrogena Healthy Skin Face Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 15; 50; 30; 40 mg/mL; mg/mL; mg/mL; mg/mL 10812-934_0c90946b-fbfa-4395-bb34-cfb8707d24a4 10812-934 HUMAN OTC DRUG Neutrogena Healthy Skin Face Sunscreen SPF 15 Octinoxate and Oxybenzone LOTION TOPICAL 20121101 20161001 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OXYBENZONE 75; 50 mg/mL; mg/mL 10812-935_f07836d6-1d52-481b-8465-5aebe0f79de8 10812-935 HUMAN OTC DRUG Neutrogena OIl Free Moisture Sunscreen SPF 15 Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 30 mg/mL; mg/mL; mg/mL 10812-945_a5da3e76-d732-476f-a18e-438967a87228 10812-945 HUMAN OTC DRUG Neutrogena T/Gel Therapeutic Extra Strength Coal Tar SHAMPOO TOPICAL 20120314 OTC MONOGRAPH FINAL part358H Neutrogena Corporation COAL TAR 10 mg/mL 10812-950_dfdf90c4-8130-4320-b1b3-ef2e5750dc31 10812-950 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Classic Ivory 10 Titanium Dioxide LIQUID TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 66 mg/mL 10812-951_dfdf90c4-8130-4320-b1b3-ef2e5750dc31 10812-951 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Natural Ivory 20 Titanium Dioxide LIQUID TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 66 mg/mL 10812-952_dfdf90c4-8130-4320-b1b3-ef2e5750dc31 10812-952 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Buff 30 Titanium Dioxide LIQUID TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 66 mg/mL 10812-953_ae4c5a4d-efa4-4164-a529-117aef585c3f 10812-953 HUMAN OTC DRUG Neutrogena Body Clear Body Wash Salicylic Acid LIQUID TOPICAL 20120321 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-954_f0a2a368-fc78-494f-af51-afda4ca89cdf 10812-954 HUMAN OTC DRUG Neutrogena Healthy Skin Anti Wrinkle Sunscreen SPF15 Ensulizole and Octinoxate CREAM TOPICAL 20130611 20160201 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation ENSULIZOLE; OCTINOXATE 10; 60 mg/g; mg/g 10812-955_dfdf90c4-8130-4320-b1b3-ef2e5750dc31 10812-955 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Natural Beige 60 Titanium Dioxide LIQUID TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 66 mg/mL 10812-956_dfdf90c4-8130-4320-b1b3-ef2e5750dc31 10812-956 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Fresh Beige 70 Titanium Dioxide LIQUID TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 66 mg/mL 10812-957_dfdf90c4-8130-4320-b1b3-ef2e5750dc31 10812-957 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Medium Beige 80 Titanium Dioxide LIQUID TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 66 mg/mL 10812-958_dfdf90c4-8130-4320-b1b3-ef2e5750dc31 10812-958 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Warm Beige 90 Titanium Dioxide LIQUID TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 66 mg/mL 10812-959_dfdf90c4-8130-4320-b1b3-ef2e5750dc31 10812-959 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Natural Tan 100 Titanium Dioxide LIQUID TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 66 mg/mL 10812-960_dfdf90c4-8130-4320-b1b3-ef2e5750dc31 10812-960 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Honey Beige 110 Titanium Dioxide LIQUID TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 66 mg/mL 10812-961_dfdf90c4-8130-4320-b1b3-ef2e5750dc31 10812-961 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Tan 120 Titanium Dioxide LIQUID TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 66 mg/mL 10812-966_ea19c071-1e1b-4e37-b5ea-4d3761f8305d 10812-966 HUMAN OTC DRUG Neutrogena Wet Skin Kids Beach and Pool Sunblock SPF 70plus helioplex Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20101201 20160815 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-967_a552cacf-7ee9-4d49-b65e-a5c680a55086 10812-967 HUMAN OTC DRUG Neutrogena Wet Skin Swim-Humidity-Sweat Sunblock SPF 85Plus Helioplex Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20101201 20160816 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 10812-968_e68d9f20-f0ae-4877-bf44-ffe81e155cbd 10812-968 HUMAN OTC DRUG Neutrogena Wet Skin Swim-Humidity-Sweat Sunscreen SPF 30 Helioplex AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE AEROSOL, SPRAY TOPICAL 20101201 20170806 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 40; 80; 50 mg/g; mg/g; mg/g; mg/g; mg/g 10812-969_a0d25df4-fd5a-451d-a232-4f70b28db5c3 10812-969 HUMAN OTC DRUG Neutrogena Wet Skin Swim-Humidity-Sweat Sunblock SPF 50 Helioplex Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20101201 20160801 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 100; 50 mg/g; mg/g; mg/g; mg/g; mg/g 10812-970_93f4781e-7649-4f45-ab4a-acbafcc9bfba 10812-970 HUMAN OTC DRUG Neutrogena Wet Skin Kids SPF 45 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20110801 20160917 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 40; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-971_dfce242a-6c4d-4563-8ccd-753294579cd0 10812-971 HUMAN OTC DRUG Neutrogena Wet Skin Kids SPF 45 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20110801 20160917 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 40; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 10812-972_71044ad2-04ad-43cd-927c-1c6696676692 10812-972 HUMAN OTC DRUG Neutrogena Wet Skin Kids Beach and Pool Sunblock SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone STICK TOPICAL 20111205 20160901 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 30 mg/g; mg/g; mg/g; mg/g; mg/g 10812-973_77fa051b-16b4-42d5-af62-6874064d840f 10812-973 HUMAN OTC DRUG Neutrogena Clear Pore Eliminating Astringent Salicylic Acid LIQUID TOPICAL 20110915 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL 10812-976_c53e8945-03b7-4a94-90b9-0e35a2b24277 10812-976 HUMAN OTC DRUG Neutrogena Visibly Even BB Broad Spectrum SPF 30 Light to Medium Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL 10812-977_232ce1d6-663e-4295-8f6d-de25a7ca3b9a 10812-977 HUMAN OTC DRUG Neutrogena Visibly Even BB Broad Spectrum SPF 30 Fair to Light Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL 10812-978_498d17c3-0d87-43e0-a37d-a788d07c5f9d 10812-978 HUMAN OTC DRUG Neutrogena Healthy Skin Anti Wrinkle Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 15; 50; 30; 40 mg/g; mg/g; mg/g; mg/g 10812-979_c3f36f8a-077e-4b56-80fc-700e3311b34d 10812-979 HUMAN OTC DRUG Neutrogena Oil Free Moisture Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 15; 50; 30; 40 mg/mL; mg/mL; mg/mL; mg/mL 10812-980_bb863a36-3a41-4b1b-a61e-2e5b44d6994a 10812-980 HUMAN OTC DRUG Neutrogena Oil Free Acne Moisturizer Pink Grapefruit Salicylic Acid LOTION TOPICAL 20141015 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 5 mg/mL 10812-981_ecbff8d0-535b-43b8-876d-a897fec0a046 10812-981 HUMAN OTC DRUG Neutrogena Rapid Clear Stubborn Acne Cleanser Benzoyl Peroxide CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part333D Neutrogena Corporation BENZOYL PEROXIDE 100 mg/mL 10812-982_fc59f8b3-4a41-4425-8809-f4e6ef823a62 10812-982 HUMAN OTC DRUG Neutrogena Rapid Clear Stubborn Acne Spot Benzoyl Peroxide GEL TOPICAL 20140905 OTC MONOGRAPH FINAL part333D Neutrogena Corporation BENZOYL PEROXIDE 100 mg/g 10816-102_104718d1-9ec4-45a7-b8cb-f85cc555d942 10816-102 HUMAN OTC DRUG BOOST REGROWTH FOR WOMEN MINOXIDIL LIQUID TOPICAL 20120301 ANDA ANDA203932 SHELBY PROFESSIONAL, INC. MINOXIDIL 2 g/100mL 10819-1080_105be743-5a58-47dd-9922-d14df76c292b 10819-1080 HUMAN OTC DRUG Prevantics Swab Chlorhexidine Gluconate and Isopropyl Alcohol SOLUTION TOPICAL 20130115 NDA NDA021524 Professional Disposables International, Inc. CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 31.5; .7 mg/mL; mL/mL 10819-1080_94cef649-de50-49ee-913b-659760eafbf0 10819-1080 HUMAN OTC DRUG Prevantics Swab Chlorhexidine Gluconate and Isopropyl Alcohol SOLUTION TOPICAL 20130115 NDA NDA021524 Professional Disposables International, Inc. CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 31.5; .7 mg/mL; mL/mL 10819-3737_753d76c0-282f-4a7b-b464-9773e5ea0bc1 10819-3737 HUMAN OTC DRUG PDI Benzalkonium Chloride Antiseptic Towelettes BZK CLOTH TOPICAL 19830101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .13 mL/mL 10819-3740_ff1b5fbf-cc40-42db-a9ce-3cee42615a14 10819-3740 HUMAN OTC DRUG Hygea Benzalkonium Chloride Antiseptic Towelette Benzalkonium Chloride CLOTH TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .13 mg/mL 10819-3883_0818fc79-48cc-4b36-817d-cd43daa97b3a 10819-3883 HUMAN OTC DRUG PVP Iodine Prep Pad Medium and Large providone iodine SWAB TOPICAL 19780101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. POVIDONE-IODINE 10 mg/mL 10819-3885_0818fc79-48cc-4b36-817d-cd43daa97b3a 10819-3885 HUMAN OTC DRUG PVP Iodine Prep Swabstick Ones and Threes providone iodine STICK TOPICAL 19780101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. POVIDONE-IODINE 10 mg/mL 10819-3890_dcfc61eb-c41e-4e65-b63b-25abc9e7afec 10819-3890 HUMAN OTC DRUG PDI Duo-Swab Povidone-Iodine Antiseptic Prep and Scrub Swabsticks Ones Povidone Iodine STICK TOPICAL 19780101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. POVIDONE-IODINE 10 mg/mL 10819-3891_44de2a1f-40ed-4a60-86e2-1086beae2dbb 10819-3891 HUMAN OTC DRUG Povidone-Iodine Cleaning scrub Swabstick 1 and 3 swabsticks providone iodine STICK TOPICAL 19780101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. POVIDONE-IODINE 10 mg/mL 10819-3912_49192772-acb0-4f87-9c2e-58f829854881 10819-3912 HUMAN OTC DRUG PDI Alcohol Prep Pad Large and Medium Alcohol CLOTH TOPICAL 19720101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .7 mL/mL 10819-3914_9c34c915-a312-4cfb-9c02-a3783f615944 10819-3914 HUMAN OTC DRUG PDI Alcohol Prep Pad Sterile Large and Medium Alcohol CLOTH TOPICAL 19720101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .7 mL/mL 10819-3915_5307869c-98d3-41e0-8881-548da1c25483 10819-3915 HUMAN OTC DRUG PDI Alcohol Swabstick Threes and Ones Alcohol STICK TOPICAL 19720101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .7 mL/mL 10819-3916_d7185081-3ae3-47c7-b093-e35a0793aeaf 10819-3916 HUMAN OTC DRUG PDI Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .7 mL/mL 10819-3917_0fb98869-69f8-4bf0-8b7a-e37ac423e5bc 10819-3917 HUMAN OTC DRUG PDI Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/mL 10819-4075_4f31d9df-0484-47d0-927a-ce6bd4bc3510 10819-4075 HUMAN OTC DRUG Prevantics Maxi Swabstick chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20130115 NDA NDA021524 Professional Disposables International, Inc. CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 31.5; .7 mg/mL; mL/mL 10819-4075_6407d5c2-f41e-43d0-adc9-b2835dba3095 10819-4075 HUMAN OTC DRUG Prevantics Maxi Swabstick chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20130115 NDA NDA021524 Professional Disposables International, Inc. CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 31.5; .7 mg/mL; mL/mL 10819-4075_647b1bd9-017e-4217-86df-0fe8b8de8905 10819-4075 HUMAN OTC DRUG Prevantics swabstick chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20130115 NDA NDA021524 Professional Disposables International, Inc. CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 31.5; .7 mg/mL; mL/mL 10819-4075_a3b52e49-df8a-4fdf-9f20-f666b89ac277 10819-4075 HUMAN OTC DRUG Prevantics swabstick chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20130115 NDA NDA021524 Professional Disposables International, Inc. CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 31.5; .7 mg/mL; mL/mL 10819-4075_d3d4f5e0-5629-4d3d-a85d-92505c336b0f 10819-4075 HUMAN OTC DRUG Prevantics swabstick chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20130115 NDA NDA021524 Professional Disposables International, Inc. CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 31.5; .7 mg/mL; mL/mL 10819-5000_fb6a434d-52d7-42c2-8c5e-0b65a1c6abe1 10819-5000 HUMAN OTC DRUG PDI Sani-Hands ALC Antimicrobial Alcohol Gel Hand Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/1 10819-5001_b80ca27c-f95d-424b-878c-9b2a7d8b60e6 10819-5001 HUMAN OTC DRUG PDI Sani-Hands ALC Antimicrobial Alcohol Gel Hand Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/1 10819-5002_32e5f231-769f-44a0-842e-58b97b4ee100 10819-5002 HUMAN OTC DRUG PDI Sani-Hands ALC Antimicrobial Alcohol Gel Hand Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/mL 10819-5003_bc42e327-c946-4622-b7f8-b23c64f0a708 10819-5003 HUMAN OTC DRUG PDI Sani-Hands ALC Antimicrobial Alcohol Gel Hand Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/mL 10819-5004_5cfa09ac-47bf-495d-8c2d-72a507828224 10819-5004 HUMAN OTC DRUG PDI Sani-Hands for Kids Antimicrobial Alcohol Gel Hand Wipes Alcohol CLOTH TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/mL 10819-5005_37d819e9-37ed-4ef1-938b-f2e18d894faf 10819-5005 HUMAN OTC DRUG PDI Sani-Hands for Kids Antimicrobial Alcohol Gel Hand Wipes Alcohol CLOTH TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/mL 10819-5802_ad71e347-1a74-4d54-b001-0546f4ca1815 10819-5802 HUMAN OTC DRUG Sani-Hands II Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/mL 10819-5808_6dd175db-cad6-4bf2-bf75-714e88175ab1 10819-5808 HUMAN OTC DRUG PDI Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20110825 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/mL 10819-5810_4b82d3a0-4fdf-4846-b590-8a9c458b7a45 10819-5810 HUMAN OTC DRUG Sani Professional Brand Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20120208 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/1 10819-5811_591f9ffe-a6e4-4c20-af70-c35be4df4a33 10819-5811 HUMAN OTC DRUG Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20120208 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/1 10819-5812_95f68516-214d-42c4-bfc5-8896d76f0400 10819-5812 HUMAN OTC DRUG Sani Professional Brand Sani-HandsInstant Hand Sani Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/mL 10819-5813_a78a877c-d46c-4a64-9423-593cacd599c7 10819-5813 HUMAN OTC DRUG PDI Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/1 10819-5814_172564ea-80b4-4d36-804b-8e9b541b80bf 10819-5814 HUMAN OTC DRUG PDI Sani-HandsInstant Hand Sani Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/mL 10819-6000_645c9b31-b443-4086-8ea1-1fa5ef6cd1e1 10819-6000 HUMAN OTC DRUG Sani Professional Brand Sani-Hands Alcohol CLOTH TOPICAL 20100525 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/1 10819-6001_2795c8b4-936c-4bea-a1b2-c0c10bc7be0c 10819-6001 HUMAN OTC DRUG Sani Professional Brand Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/mL 10819-6002_0b825cf9-6465-4b7c-938e-5342e7470fbf 10819-6002 HUMAN OTC DRUG Sani Professional Brand Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/mL 10819-6003_c152f398-5780-48d9-a69c-7a62602fe6ff 10819-6003 HUMAN OTC DRUG Sani-Hands for Kids Alcohol CLOTH TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/1 10819-6004_1746f897-fd7a-48e7-988e-7f72089eb510 10819-6004 HUMAN OTC DRUG Sani Professional Brand Sani-Hands for Kids Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20100525 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/mL 10819-6005_fd097542-b65f-46e5-883c-1e8f58d8abc9 10819-6005 HUMAN OTC DRUG Sani Professional Brand Sani-Hands with Tencel Instant Hand Sanitizing Wipes Alcohol SOLUTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/mL 10819-7001_f2871bc2-0c80-4d3a-aba8-1befda4323da 10819-7001 HUMAN OTC DRUG Sani-Hands for Kids Antibacterial Moist Wipes Benzalkonium Chloride CLOTH TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .24 mg/mL 10819-7002_1b9a9119-32c9-437b-9570-eab4d75066de 10819-7002 HUMAN OTC DRUG Sani Professional Brand Sanitizing Wipes Benzalkonium Chloride CLOTH TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .13 mg/mL 10819-7003_df8fc042-2d28-4c61-be03-532359563be4 10819-7003 HUMAN OTC DRUG Sani Professional Brand Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/mL 10819-7004_136849bc-ebf3-4fd0-a330-411b2bd14fba 10819-7004 HUMAN OTC DRUG Sani Professional Brand Sani-Hands for Kids Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/mL 10819-7005_59abc4f6-97ce-4582-866f-08891de8d646 10819-7005 HUMAN OTC DRUG Sani Professional Brand Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/mL 10819-7006_e116f741-1c38-4513-a4ea-45a4ff5232a6 10819-7006 HUMAN OTC DRUG Nice and Clean Antibacterial Hand Wipes Benzalkonium Chloride CLOTH TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .13 mg/mL 10819-7007_28c9f9dc-c287-4246-8aa9-8b4da59e4818 10819-7007 HUMAN OTC DRUG Sani Professional Brand Sani-Hands BasicsHand Wipes Hand Wipes Benzalkonium Chloride CLOTH TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .13 mg/mL 10819-7008_bf33b5de-34c9-4cc7-a4ab-4e84734ccc1e 10819-7008 HUMAN OTC DRUG Sani Professional Brand Sani-Hands Basics BZKHand Wipes Hand Wipes Hand Wipes Hand Wipes Hand Wipes Hand Wipes Benzalkonium Chloride CLOTH TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .13 mg/mL 10819-7009_f7fff7a8-eb72-41d8-93d4-85f3ea708a1a 10819-7009 HUMAN OTC DRUG Sani Professional Brand Sani-Hands for KidsHand Wipes Hand Wipes Benzalkonium Chloride CLOTH TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .13 mg/mL 10819-7010_34f254d2-7b23-412a-bacc-69ebdea7fbb8 10819-7010 HUMAN OTC DRUG Sani-Hands for Kids Antibacterial Moist Wipes Benzalkonium Chloride CLOTH TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .13 mg/mL 10819-7011_4c6b0584-df7a-4fe3-a5b1-ed0b4c1cdbeb 10819-7011 HUMAN OTC DRUG Wet Nap Antibacterial Hand Wipes Benzalkonium Chloride CLOTH TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International Inc. BENZALKONIUM CHLORIDE .13 mg/mL 10819-7012_1d6862a1-c0d9-4ce5-ad6f-d45bf18e629f 10819-7012 HUMAN OTC DRUG Wet Nap Antibacterial Hand Wipes Benzalkonium Chloride CLOTH TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International Inc. BENZALKONIUM CHLORIDE .13 mg/mL 10825-001_c9fef923-1bc9-45f8-b5f7-25abcbf73ae0 10825-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19740101 UNAPPROVED MEDICAL GAS Northern Welding Supply OXYGEN 99 L/100L 10825-002_85a53027-c9f9-410f-ae5b-e8e970e8f1f6 10825-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19740101 UNAPPROVED MEDICAL GAS Northern Welding Supply OXYGEN 99 L/100L 10825-003_25661f79-6d3a-4b03-961b-5c0186242b3e 10825-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20080701 UNAPPROVED MEDICAL GAS Northern Welding Supply NITROGEN 90 L/100L 10827-0002_66fbcd67-91ef-4c3c-a973-7e2657d6242a 10827-0002 HUMAN OTC DRUG CLAIRES HAND SANITIZER GEL TOPICAL 20100115 OTC MONOGRAPH NOT FINAL part333 Yusef Manufacturing Laboratories, LLC ALCOHOL .62 g/g 10827-0003_2595d684-91d4-4557-bf05-d74b0d7103a1 10827-0003 HUMAN OTC DRUG ICING HAND SANITIZER GEL TOPICAL 20100310 OTC MONOGRAPH NOT FINAL part333 Yusef Manufacturing Laboratories, LLC ALCOHOL .62 g/g 10842-100_8af7f30a-ec27-431f-af3b-b7e6c7a9557a 10842-100 HUMAN OTC DRUG Doctor Hoys Natural Pain Relief menthol, camphor GEL TOPICAL 20050510 OTC MONOGRAPH NOT FINAL part348 DOCTOR HOY'S, LLC CAMPHOR (NATURAL); MENTHOL 50; 50 mg/mL; mg/mL 10842-200_1c414fb2-e15e-486c-b10c-8225e1fb8034 10842-200 HUMAN OTC DRUG DOCTOR HOYS Arnica Boost arnica montana, msm CREAM TOPICAL 20130801 UNAPPROVED DRUG OTHER DOCTOR HOY'S, LLC ARNICA MONTANA FLOWER; DIMETHYL SULFONE 5; 2 g/mL; g/mL 10842-212_416fcb3c-3e75-423f-adaa-79ac354b735f 10842-212 HUMAN OTC DRUG DOCTOR HOYS NATURAL PAIN RELIEF CAMPHOR MENTHOL GEL TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part356 DOCTOR HOY'S, LLC CAMPHOR (NATURAL); MENTHOL 5; 5 g/100mL; g/100mL 10849-001_dc30e569-a551-401a-86c2-f58ba4c00ec1 10849-001 HUMAN OTC DRUG Terapie Callus Remover SALICYLIC ACID LIQUID TOPICAL 20111104 OTC MONOGRAPH FINAL part358F Armand Dupree SALICYLIC ACID 17 mL/100mL 10849-002_468845c0-b070-400d-8efc-afa95acff0ab 10849-002 HUMAN OTC DRUG Terapie Anti-Fungal MICONAZOLE NITRATE CREAM TOPICAL 20111104 OTC MONOGRAPH FINAL part333C Armand Dupree Inc. MICONAZOLE NITRATE 2 g/100g 10849-003_d2b292f5-845d-4a86-ab71-ff14e10f3bd0 10849-003 HUMAN OTC DRUG Acne Off Acne Treatment SALICYLIC ACID GEL TOPICAL 20120419 OTC MONOGRAPH FINAL part333D Armand Dupree SALICYLIC ACID 20 g/100g 10849-004_585fe53a-28fc-4724-bab5-1c2aa87e4d58 10849-004 HUMAN OTC DRUG Acne Off Acne Treatment Facial SALICYLIC ACID LOTION TOPICAL 20120419 OTC MONOGRAPH FINAL part333D Armand Dupree SALICYLIC ACID 120 mL/100mL 10867-001_c6cba009-be23-4094-ad5a-678a22f74223 10867-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20041001 UNAPPROVED MEDICAL GAS Mitchell Home Medical, Inc. OXYGEN 990 mL/L 10882-527_4066d15a-ea84-4e54-b8f8-90af7100249d 10882-527 HUMAN OTC DRUG LidoPatch Pain Relief lidocaine and menthol PATCH TRANSDERMAL 20121213 OTC MONOGRAPH NOT FINAL part348 JAR Laboratories LIDOCAINE; MENTHOL 40; 50 mg/1; mg/1 10884-2228_992d0c84-689b-4cbf-8e0c-e04b9e1d0d94 10884-2228 HUMAN OTC DRUG BF-PARADAC Acetaminophen TABLET ORAL 20010916 OTC MONOGRAPH NOT FINAL part343 Bright Future Pharmaceuticals Factory ACETAMINOPHEN 500 mg/1 10884-2265_f73a91a3-06b9-4651-a2ce-6f1087ade498 10884-2265 HUMAN OTC DRUG BF-MICOZO Miconazole Nitrate CREAM TOPICAL 20110308 OTC MONOGRAPH FINAL part333C Bright Future Pharmaceuticals Factory MICONAZOLE NITRATE 20 mg/g 10885-001_79e3adbb-6c31-4a1c-8200-1ae6ec96aa2a 10885-001 HUMAN PRESCRIPTION DRUG DaunoXome daunorubicin citrate INJECTION, LIPID COMPLEX INTRAVENOUS 20120213 NDA NDA050704 Galen US Inc DAUNORUBICIN CITRATE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 10885-002_736e07fc-aa01-41c9-8d35-205deb7ea421 10885-002 HUMAN PRESCRIPTION DRUG SYNERA lidocaine and tetracaine PATCH CUTANEOUS 20131201 NDA NDA021623 Galen US Incorporated LIDOCAINE; TETRACAINE 70; 70 mg/1; mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 10888-5001_f196725f-4844-4a4e-b5df-40f8b1a2389f 10888-5001 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20140327 ANDA ANDA202539 Banner Pharmacaps PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 10888-5002_f196725f-4844-4a4e-b5df-40f8b1a2389f 10888-5002 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20140327 ANDA ANDA202539 Banner Pharmacaps PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 10888-5003_f196725f-4844-4a4e-b5df-40f8b1a2389f 10888-5003 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20140327 ANDA ANDA202539 Banner Pharmacaps PARICALCITOL 4 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 10888-5006_cf6e5d46-d0fc-4708-99e9-c05169606e37 10888-5006 HUMAN PRESCRIPTION DRUG Amantadine HCl AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20121101 ANDA ANDA078720 Banner Pharmacaps Inc AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 10888-7135_cfbb9566-cfae-4fd3-8256-384521cefcf0 10888-7135 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20140101 ANDA ANDA200900 Banner Pharmacaps PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 10888-7136_cfbb9566-cfae-4fd3-8256-384521cefcf0 10888-7136 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20140101 ANDA ANDA200900 Banner Pharmacaps PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 10889-100_705de695-7bac-4c0e-93fd-91fbd1feea2f 10889-100 HUMAN OTC DRUG Dial Gold Bar Antibacterial Deodorant Soap triclocarban SOAP CUTANEOUS 20090714 OTC MONOGRAPH NOT FINAL part333 VVF Kansas Services LLC TRICLOCARBAN .6 1/1 10889-102_e551d7ef-bd4b-4c8a-bfb5-3b734960e15f 10889-102 HUMAN OTC DRUG Family Dollar Celsius Antiperspirant Deodorant 2 oz stick aluminum zirconium tetrachlorohydrex gly STICK CUTANEOUS 20080404 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 1/1 10889-103_92380b63-78da-44ef-b05d-2015a04bd3b0 10889-103 HUMAN OTC DRUG Dead Down Wind ScentPrevent Antiperspirant Aluminum Chlorohydrate STICK CUTANEOUS 20080815 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM CHLOROHYDRATE 14.4 1/1 10889-105_454a03ff-f652-410a-830b-5ba3caf5f8d9 10889-105 HUMAN OTC DRUG Walgreens Original Antiperspirant Deodorant 2.7 oz aluminum zirconium tetrachlorohydrex gly STICK CUTANEOUS 20080404 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 16 1/1 10889-106_b32a37b4-19e7-4f49-a97f-b1cc37982ce8 10889-106 HUMAN OTC DRUG Walgreens Active Stick Antiperspirant Deodorant 3 oz aluminum zirconium tetrachlorohydrex gly STICK CUTANEOUS 20080404 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 1/1 10889-110_e3832b92-a779-488b-97b3-7c23be1d2e4b 10889-110 HUMAN OTC DRUG Lacura Extreme Blast anti-perspirant deodorant ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK CUTANEOUS 20101213 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 250 mg/g 10889-111_c899a4f9-dae8-43b2-99de-5c27c1bef855 10889-111 HUMAN OTC DRUG Lacura Ultimate Endurance Pure Sport anti-perspirant deodorant ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK CUTANEOUS 20101213 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 250 mg/g 10889-112_cdce1c44-7a77-45aa-959b-803eb29a14de 10889-112 HUMAN OTC DRUG Lacura Invisible Solid Powder Fresh anti-perspirant deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK CUTANEOUS 20101213 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 250 mg/g 10889-113_da93fcb2-8155-4e70-b0b5-464faf6d6ba7 10889-113 HUMAN OTC DRUG Lacura Invisible Solid Shower Fresh anti-perspirant deodorant ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK CUTANEOUS 20101213 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 250 mg/g 10889-201_5b42a290-b81b-4f66-8b53-b34f7254acef 10889-201 HUMAN OTC DRUG Walgreens Cool N Heat Therapy Pain Relief Stick Methyl Salicylate and Menthol STICK TOPICAL 20080815 OTC MONOGRAPH FINAL part348 VVF Kansas Services LLC MENTHOL; METHYL SALICYLATE 10; 30 1/1; 1/1 10889-202_2a497698-9a99-404c-aac8-cf48ffc43eb3 10889-202 HUMAN OTC DRUG CVS Cold and Hot Pain Relieving Stick Methyl Salicylate and Menthol STICK TOPICAL 20090327 OTC MONOGRAPH FINAL part348 VVF Kansas Services LLC MENTHOL; METHYL SALICYLATE 10; 30 1/1; 1/1 10889-301_b3598ec2-9432-4870-bf1b-0f79c301b6ae 10889-301 HUMAN OTC DRUG DG Body Antibacterial Deodorant 3.5 oz bar triclocarban SOAP CUTANEOUS 20090710 OTC MONOGRAPH NOT FINAL part333 VVF Kansas Services LLC TRICLOCARBAN .6 1/1 10893-083_2a3dc882-b840-4447-8e49-ad890292b3f5 10893-083 HUMAN OTC DRUG Naturasil Scabies Sulfur CREAM TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 1 [hp_X]/1 10893-150_fab0ab29-1f86-495f-829e-385594f5352e 10893-150 HUMAN OTC DRUG Naturasil Eczema Natrum Muriaticum LIQUID TOPICAL 20120202 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SODIUM CHLORIDE 6 [hp_X]/10mL 10893-199_fbb31336-f8ed-4705-b30a-94f20bb702d4 10893-199 HUMAN OTC DRUG Naturasil Cherry Angiomas Phosphoricum Acidum LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation PHOSPHORIC ACID 6 [hp_X]/1 10893-200_71056361-0f5a-4be3-a98c-f1c74b0026e4 10893-200 HUMAN OTC DRUG Naturasil Jock Itch Sulfur LIQUID TOPICAL 20120202 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 10893-220_f2f3a41b-b9af-41d0-bc1b-6fbb5c8411e4 10893-220 HUMAN OTC DRUG Naturasil Ringworm Sulfur LIQUID TOPICAL 20120202 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 10893-240_bd9efb64-1216-4b37-bbb1-aab3affa2ab5 10893-240 HUMAN OTC DRUG Naturasil Tinea Versicolor Sulfur LIQUID TOPICAL 20120101 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/mL 10893-240_e7429d1e-396d-4ebe-9ed9-c0db7e70263a 10893-240 HUMAN OTC DRUG Naturasil Tinea Versicolor Sulfur LIQUID TOPICAL 20120101 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/mL 10893-260_5164432e-9195-41d0-b36b-946cabd21ed6 10893-260 HUMAN OTC DRUG Naturasil Athletes Foot Sulfur LIQUID TOPICAL 20120202 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 10893-270_c1045f80-0c15-4184-85b6-efb4c0bb19a3 10893-270 HUMAN OTC DRUG Naturasil Internal Parasites Sulfur LIQUID ORAL 20120111 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/30mL 10893-300_14c63157-0582-495f-b8eb-7450b1d49583 10893-300 HUMAN OTC DRUG Naturasil Nail Fungus Thuja Occidentalis LIQUID TOPICAL 20120202 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 10893-335_740ab809-0ebc-430e-ba4d-c6a1e4c1e5f9 10893-335 HUMAN OTC DRUG Naturasil Scabies Sulfur LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 10893-342_2534251c-c25a-43f6-9696-f229e25b1a4c 10893-342 HUMAN OTC DRUG Naturasil Scabies Sulfur LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 10893-350_9b77405c-035e-4c3f-bf7f-9688dd27a875 10893-350 HUMAN OTC DRUG Naturasil Neuropathy Rub Hypericum and Arnica Montana LIQUID TOPICAL 20120111 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. ARNICA MONTANA; ST. JOHN'S WORT 1; 6 [hp_X]/30mL; [hp_X]/30mL 10893-359_bcfac0db-b3f3-4c67-84f0-6b8f425a7df6 10893-359 HUMAN OTC DRUG Naturasil Acne PHOSPHORIC ACID LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. PHOSPHORIC ACID 6 [hp_X]/1 10893-400_3f996ddf-656e-494a-bf1c-1d9f532752db 10893-400 HUMAN OTC DRUG Naturasil Scabies Sulfur LIQUID TOPICAL 20120202 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 10893-450_50fa61d9-ab73-4d82-8264-a75dd8a0d0b1 10893-450 HUMAN OTC DRUG Dr. Berrys APOTHECARY Muscle and Joint Pain Therapy Hypericum, Capsicum Annuum, Arnica Montana OIL TOPICAL 20120824 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. ARNICA MONTANA; CAPSICUM; ST. JOHN'S WORT 1; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 10893-452_1cab59a1-25a1-4f21-bb44-91c0efc86275 10893-452 HUMAN OTC DRUG Naturasil Muscle and Joint Pain Hypericum 6X HPUS, Capsicum Annuum 3X HPUS, Arnica Montana 1X HPUS LIQUID TOPICAL 20121203 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. ARNICA MONTANA; CAPSICUM; ST. JOHN'S WORT 1; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 10893-460_aeaab654-d446-4fec-8a7f-5cafa4bb4440 10893-460 HUMAN OTC DRUG Dr. Berrys APOTHECARY Gout Therapy Oil Capsicum Annuum, Arnica Montana, Hypericum OIL TOPICAL 20120822 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. ARNICA MONTANA; CAPSICUM; ST. JOHN'S WORT 1; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 10893-462_bf6fe716-4a6e-4800-8633-d0ce06ec03ee 10893-462 HUMAN OTC DRUG Naturasil Gout Capsicum Annuum, Arnica Montana, Hypericum LIQUID TOPICAL 20121203 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. ARNICA MONTANA; CAPSICUM; ST. JOHN'S WORT 1; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 10893-465_a5a04cfd-c1f6-45a0-becb-da23d2074fe7 10893-465 HUMAN OTC DRUG Dr. Berrys APOTHECARY Foot and Ankle Therapy Oil Capsicum Annuum, Hypericum, Arnica Montana OIL TOPICAL 20120822 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. ARNICA MONTANA; CAPSICUM; ST. JOHN'S WORT 1; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 10893-470_bf446085-db38-40e4-8a18-16cdd8382950 10893-470 HUMAN OTC DRUG Dr. Berrys APOTHECARY Neuropathy Therapy Hypericum, Arnica Montana OIL TOPICAL 20120822 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. ARNICA MONTANA; ST. JOHN'S WORT 1; 6 [hp_X]/mL; [hp_X]/mL 10893-500_706a0dcb-90ec-4428-b0b1-49dc18127082 10893-500 HUMAN OTC DRUG Naturasil Molluscum Thuja Occidentalis LIQUID TOPICAL 20120113 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/mL 10893-520_93726dd1-ae3f-458e-9dd8-95c1790c65b9 10893-520 HUMAN OTC DRUG Naturasil Skin Tags Thuja Occidentalis LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 10893-520_c4fb3f93-eb70-441c-8278-9e4ba4225c8c 10893-520 HUMAN OTC DRUG Naturasil Skin Tags Thuja Occidentalis LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 10893-540_ef3b4373-3e37-41e3-b9e1-2fabeda1c62a 10893-540 HUMAN OTC DRUG Naturasil Warts Thuja Occidentalis LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/mL 10893-600_7aec57e4-7678-49ec-ad0f-768dba449051 10893-600 HUMAN OTC DRUG Naturasil Sulfur-Lavender Sulfur SOAP TOPICAL 20120118 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 1; 6 [hp_X]/g; [hp_X]/g 10893-620_3d7be7eb-609b-4955-9356-006609458bfd 10893-620 HUMAN OTC DRUG Naturasil Tinea Versicolor Sulfur-Lavender SOAP TOPICAL 20120101 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 1; 6 [hp_X]/g; [hp_X]/g 10893-625_46881a1a-2197-49e6-a5d5-fbb6fffe88e6 10893-625 HUMAN OTC DRUG Naturasil Athletes Foot Sulfur LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 10893-630_37e2533a-e8d5-42dc-9422-895d40648fca 10893-630 HUMAN OTC DRUG Naturasil Nail Fungus Sulfur and Thuja Occidentalis SOAP TOPICAL 20120113 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 1; 6 [hp_X]/127.6g; [hp_X]/127.6g 10893-632_5f5dd8c9-231c-4f13-aee8-8acd578d01f1 10893-632 HUMAN OTC DRUG Naturasil Jock Itch Sulfur LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 10893-656_dd377be3-b78b-4dec-8522-41e0dcfe66b5 10893-656 HUMAN OTC DRUG Naturasil Nail Fungus Thuja Occidentalis LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 10893-663_d3bb3a3b-a667-4c9d-b434-16db9d49af37 10893-663 HUMAN OTC DRUG Naturasil Nail Fungus Thuja Occidentalis LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 10893-687_b4427511-4a39-4051-97ff-b7bdc63ca3a8 10893-687 HUMAN OTC DRUG Dermisil Warts Thuja Occidentalis LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 10893-694_98e54644-1a72-4671-b36b-5dc7189d1054 10893-694 HUMAN OTC DRUG Naturasil Warts Thuja Occidentalis LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 10893-710_33071a33-dd65-4517-a48d-fc3f4bb33491 10893-710 HUMAN OTC DRUG Naturasil Scars Silicea LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SILICON DIOXIDE 6 [hp_X]/mL 10893-730_17589587-d400-44fc-81b1-6f0ddd0827e2 10893-730 HUMAN OTC DRUG Naturasil Stretch Marks Silicea LIQUID TOPICAL 20120112 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SILICON DIOXIDE 6 [hp_X]/mL 10893-750_3e705b35-323e-4665-a498-ce9c51659745 10893-750 HUMAN OTC DRUG Naturasil Shingles Natrum Muriaticum LIQUID TOPICAL 20120112 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SODIUM CHLORIDE 6 [hp_X]/10mL 10893-793_3022f4c8-ddf7-4a2f-a9ae-6620baa7717a 10893-793 HUMAN OTC DRUG Naturasil Bite Relief Phosphoricum Acidum LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. PHOSPHORIC ACID 6 [hp_X]/1 10893-892_1647f412-2755-4215-b6a9-828fe7832918 10893-892 HUMAN OTC DRUG Naturasil Ringworm Sulfur LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 10893-900_04f2d19c-40ed-4636-9012-4765e680e8ff 10893-900 HUMAN OTC DRUG CobraZol Arnica montana, Capsicum annum, Crotalus horridus, Lachesis muta, Naja tripudians GEL TOPICAL 20130821 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. ARNICA MONTANA; CAPSICUM; CROTALUS HORRIDUS HORRIDUS VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM 1; 2; 6; 8; 5 [hp_X]/88.721mL; [hp_X]/88.721mL; [hp_X]/88.721mL; [hp_X]/88.721mL; [hp_X]/88.721mL 10893-908_3351ef57-59bd-4406-bab3-aa7c65270ac8 10893-908 HUMAN OTC DRUG Naturasil Ringworm SULFUR LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 10913-001_5725c1d4-36e4-4d61-b856-587476f6fa8d 10913-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19620101 UNAPPROVED MEDICAL GAS Prest-O-Sales & Service Inc OXYGEN 99 L/100L 10913-010_a20124a9-b33d-4a0b-b46b-377d67c7d689 10913-010 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20100101 UNAPPROVED MEDICAL GAS Prest-O-Sales & Service Inc NITROGEN 99 L/100L 10914-550_09797f41-127b-4acf-b98c-79f168382249 10914-550 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20080630 ANDA ANDA040658 Brighton Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 10914-551_09797f41-127b-4acf-b98c-79f168382249 10914-551 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20080630 ANDA ANDA040556 Brighton Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 10914-552_09797f41-127b-4acf-b98c-79f168382249 10914-552 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20070419 ANDA ANDA040556 Brighton Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 10922-825_a7594a20-f46e-4b33-91d5-410cc5e97b8d 10922-825 HUMAN PRESCRIPTION DRUG Finacea azelaic acid GEL TOPICAL 20041224 NDA NDA021470 Intendis Inc. AZELAIC ACID .15 g/g Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE] 10922-826_a7594a20-f46e-4b33-91d5-410cc5e97b8d 10922-826 HUMAN PRESCRIPTION DRUG Finacea azelaic acid KIT 20110412 NDA NDA021470 Intendis Inc. 10922-828_71fcf85b-04ff-4630-872d-cd2df7ba6842 10922-828 HUMAN PRESCRIPTION DRUG DESONATE desonide GEL TOPICAL 20100128 NDA NDA021844 Intendis Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 10927-101_3fc1f920-0ca0-48db-9eac-5a5e3a8b36d0 10927-101 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19381020 UNAPPROVED MEDICAL GAS PURITY CYLINDER GASES, INC. NITROGEN 99 L/100L 10927-102_1e0a40c1-b35a-4e49-83f9-658fe9239b6d 10927-102 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19381020 UNAPPROVED MEDICAL GAS PURITY CYLINDER GASES, INC. NITROUS OXIDE 99 L/100L 10927-103_19f27214-b535-4f63-bd84-653429ae7d09 10927-103 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19381020 UNAPPROVED MEDICAL GAS PURITY CYLINDER GASES, INC. OXYGEN 99 L/100L 10927-104_36416d93-b817-4fe9-931a-0e5063b5b81b 10927-104 HUMAN PRESCRIPTION DRUG AIR AIR GAS RESPIRATORY (INHALATION) 19381020 UNAPPROVED MEDICAL GAS PURITY CYLINDER GASES, INC. AIR 99 L/100L 10927-105_b80500ed-27a7-45c1-a6d5-20a3270891ea 10927-105 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN LIQUID RESPIRATORY (INHALATION) 19381020 UNAPPROVED MEDICAL GAS PURITY CYLINDER GASES, INC. OXYGEN 99 L/100L 10927-106_b46a3773-dbc8-48ef-a3c6-7fa48d7047dc 10927-106 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN LIQUID RESPIRATORY (INHALATION) 19381020 UNAPPROVED MEDICAL GAS PURITY CYLINDER GASES, INC. NITROGEN 99 L/100L 10942-1094_491e8fd8-8c11-46c6-a67c-b29f49cbe759 10942-1094 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19710101 UNAPPROVED MEDICAL GAS Welders Supply - Raimy Corporation OXYGEN 99 L/100L 10956-003_74179880-e043-40b7-ba3a-8a3e7a5cc557 10956-003 HUMAN OTC DRUG CVS Chest Congestion Relief DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20091207 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 10956-014_c3ec7d96-290e-45e6-9f2e-4e7fb5420c10 10956-014 HUMAN OTC DRUG Care One Chest Congestion Relief DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20091207 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 10956-020_0a70b5ed-9dd4-43ab-8064-e4a5770b5d3b 10956-020 HUMAN OTC DRUG Premier Value Chest Congestion and cough releif DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20091130 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 10956-200_a6ebd78f-741b-4093-8f2e-4feea0949b97 10956-200 HUMAN OTC DRUG Refenesen guaifenesin SYRUP ORAL 20140515 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co. GUAIFENESIN 200 mg/5mL 10956-381_50b1e58e-07f2-43be-8795-9f6126928b8a 10956-381 HUMAN OTC DRUG Refenesen Chest Congestion Relief PE Guaifenesin/phenylephrine TABLET ORAL 20140925 OTC MONOGRAPH FINAL part341 REESE PHARMACEUTICAL CO. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 10956-618_b1025890-f97a-4f33-9000-9dd9de583da5 10956-618 HUMAN OTC DRUG Pinworm Medicine Pyrantal pamoate SUSPENSION ORAL 20070101 OTC MONOGRAPH FINAL part357B Reese Pharmaceutical Company PYRANTEL PAMOATE 144 mg/mL 10956-674_bea99183-3189-4191-8d09-0c3cb986abc9 10956-674 HUMAN OTC DRUG Double Tussin Intense Cough Reliever DM Dextromethorphan Hydrobromide / Guaifenesin LIQUID ORAL 20110802 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 300 mg/5mL; mg/5mL 10956-761_7a7843e4-292f-4bcf-8dfb-d0973f3407aa 10956-761 HUMAN OTC DRUG Freds Chest Congestion Relief DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20091130 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 10956-762_08c563b1-8efe-428b-bc73-ecc7318ee492 10956-762 HUMAN OTC DRUG Powerful Pain Medicine Acetaminophen TABLET ORAL 19900630 OTC MONOGRAPH NOT FINAL part343 REESE PHARMACEUTICAL CO. ACETAMINOPHEN 650 mg/1 10956-788_8c2f21fe-dc31-4c4d-9350-f80570271bf2 10956-788 HUMAN OTC DRUG Refenesen Chest Congestion Relief Guaifenesin TABLET ORAL 20030923 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co GUAIFENESIN 400 mg/1 10956-791_f6290f7a-6bb6-4686-aaf6-ffc3df8400d4 10956-791 HUMAN OTC DRUG Refenesen Chest Congestion Relief pe Guaifenesin/phenylephrine TABLET ORAL 20060220 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 10956-812_73013d4d-8946-42cc-8234-f56b523c16d0 10956-812 HUMAN OTC DRUG REESES ONETAB ALLERGY AND SINUS ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20100405 OTC MONOGRAPH FINAL part341 REESE PHARMACEUTICAL CO. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 10956-813_36179e63-1f04-41b1-97a5-90c425259f17 10956-813 HUMAN OTC DRUG REESES ONETAB COLD AND FLU ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20100405 OTC MONOGRAPH FINAL part341 REESE PHARMACEUTICAL CO. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 10956-814_f8f2cbdf-abec-4d20-b1e9-41f66b21dad1 10956-814 HUMAN OTC DRUG Reese ONETAB Congestion and cough Guaifenesin/phenylephrine TABLET ORAL 20100601 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 10967-057_3222fd3d-5e0c-40ac-ad46-9bef480bafab 10967-057 HUMAN OTC DRUG HI AND DRI ANTIPERSPIRANT ROLL-ON POWDER FRESH ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 19820101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM CHLOROHYDRATE .18 g/mL 10967-100_381404fa-c532-46f5-a3b0-cab352c163dd 10967-100 HUMAN OTC DRUG Hi and Dri Antiperspirant Roll-On Unscented ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 19820101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM CHLOROHYDRATE .18 g/mL 10967-582_454080bc-76d0-4b38-a2ec-8215692c9c52 10967-582 HUMAN OTC DRUG Mens Mitchum Advanced Invisible Roll-On Antiperspirant Deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY LIQUID TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL 10967-583_50ea516c-c1a6-4f98-bce9-ddcec2da99a9 10967-583 HUMAN OTC DRUG Womens Mitchum Advanced Invisible Roll-On Antiperspirant Deodorant Powder Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY LIQUID TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL 10967-584_75ef2ef2-cf56-49b6-95c6-0e86d2017273 10967-584 HUMAN OTC DRUG Mens Mitchum Advanced Invisible Roll-On Antiperspirant Deodorant Sport ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY LIQUID TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL 10967-586_421de883-5261-49de-a0dc-83fea72bf1e1 10967-586 HUMAN OTC DRUG Womens Mitchum Advanced Invisible Antiperspirant Deodorant Solid Powder Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/g 10967-587_908669e4-979b-43bf-a63b-e1e2cf160fde 10967-587 HUMAN OTC DRUG Womens Mitchum Advanced Invisible Antiperspirant Deodorant Solid Pure Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/g 10967-588_dd13ae33-9bab-4eab-8f59-036232b19323 10967-588 HUMAN OTC DRUG Womens Mitchum Advanced Invisible Antiperspirant Deodorant Solid Powder Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/g 10967-589_2652f533-5dc8-4a43-8164-2ef06ccf3892 10967-589 HUMAN OTC DRUG Womens Mitchum Advanced Invisible Antiperspirant Deodorant Solid Clean Control ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/g 10967-590_84877bd9-e305-42a3-aa4f-2eafd3825360 10967-590 HUMAN OTC DRUG Womens Mitchum Advanced Invisible Antiperspirant Deodorant Solid Sport ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/g 10967-595_2da3ebc7-1daa-439c-bbb7-c4fccd513559 10967-595 HUMAN OTC DRUG Womens Mitchum Clinical Antiperspirant Deodorant Soft Solid Powder Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/g 11023-001_562d524b-13cb-4f56-9f1c-a4c3c42db6aa 11023-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030101 UNAPPROVED MEDICAL GAS Corp Brothers, Incorporated OXYGEN 990 mL/L 11023-003_ac00a2e5-313b-4eae-bd94-0244578cc461 11023-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19800101 UNAPPROVED MEDICAL GAS Corp Brothers, Incorporated NITROGEN 990 mL/L 11026-2639_2b42c80e-66ae-4a04-8fa0-935d164f2584 11026-2639 HUMAN OTC DRUG Kola-Pectin DS Bismuth Subsalicylate LIQUID ORAL 20071001 OTC MONOGRAPH FINAL part335 Seyer Pharmatec, Inc. BISMUTH SUBSALICYLATE 525 mg/15mL 11026-2640_a4968656-5403-4b21-abf4-102b9dd4e74e 11026-2640 HUMAN OTC DRUG Broncotron Dextromethorphan, Guaifenesin LIQUID ORAL 19980101 OTC MONOGRAPH FINAL part341 Seyer Pharmatec, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 11026-2650_9146a6b6-cbaf-4304-b52f-6e6251b3f350 11026-2650 HUMAN OTC DRUG Broncotron S Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20121215 OTC MONOGRAPH FINAL part341 Seyer Pharmatec, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/5mL; mg/5mL 11026-2662_02031407-0572-4c92-92c7-47084ad2da9d 11026-2662 HUMAN OTC DRUG Panatuss Pediatric Drops DXP Dexbrompheniramine Maleate, Dextromethorphan, Phenylephrine LIQUID ORAL 20050901 OTC MONOGRAPH FINAL part341 Seyer Pharmatec, Inc. DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE .5; 5; 2.5 mg/mL; mg/mL; mg/mL 11026-2675_4de7dbba-7d73-400f-bf64-ea96d8dc5cdd 11026-2675 HUMAN OTC DRUG Panatuss DXP Dexbrompheniramine Maleate, Dextromethorphan, Phenylephrine LIQUID ORAL 20050901 OTC MONOGRAPH FINAL part341 Seyer Pharmatec, Inc. DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 20; 10 mg/5mL; mg/5mL; mg/5mL 11026-2681_1b8c7fa9-9b2e-46a6-86c9-7f399f6a3fc1 11026-2681 HUMAN OTC DRUG Broncotron D Guaifenesin, Dextromethorphan, Phenyphrine Hydrchloride LIQUID ORAL 20071001 OTC MONOGRAPH FINAL part341 SEYER PHARMATEC, INC. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 5 mg/5mL; mg/5mL; mg/5mL 11026-2775_53748220-e18b-47ff-8850-6cecd3f17917 11026-2775 HUMAN OTC DRUG Panatuss PED Chlophedianol Hydrchloride, Dexchlorpheniramine Maleate, Pseudoephedrine Hydrochloride LIQUID ORAL 20121215 OTC MONOGRAPH FINAL part341 Seyer Pharmatec, Inc. CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 25; 2; 60 mg/5mL; mg/5mL; mg/5mL 11026-2780_2a832371-f2dd-4fee-960b-4af3cc78b83e 11026-2780 HUMAN OTC DRUG Broncotron PED Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20121215 OTC MONOGRAPH FINAL part341 Seyer Pharmatec, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 350; 10 mg/5mL; mg/5mL; mg/5mL 11026-2785_a328acf9-7f88-4073-83f5-c6584b2b78b4 11026-2785 HUMAN OTC DRUG Panatuss PED Chlophedianol Hydrchloride, Dexchlorpheniramine Maleate, Pseudoephedrine Hydrochloride SOLUTION/ DROPS ORAL 20121215 OTC MONOGRAPH FINAL part341 Seyer Pharmatec, Inc. CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 6.25; .5; 15 mg/mL; mg/mL; mg/mL 11026-2790_fa918a9a-eb8d-4206-a777-7b5c975101d9 11026-2790 HUMAN OTC DRUG Broncotron PED Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl SOLUTION/ DROPS ORAL 20121215 OTC MONOGRAPH FINAL part341 Seyer Pharmatec, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 11045-0303_fe955d71-6dc5-48ca-9c81-bf990fca3f97 11045-0303 HUMAN OTC DRUG Soleo Organics Sunscreen Zinc Oxide CREAM TOPICAL 20070120 OTC MONOGRAPH NOT FINAL part352 Skin Elements USA, LLC ZINC OXIDE 223 mg/g 11054-009_55ddde42-26f5-43e6-b7ad-cdc604ff8ab4 11054-009 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS CUTANEOUS; RESPIRATORY (INHALATION) 19971014 UNAPPROVED MEDICAL GAS AIRGAS USA, LLC OXYGEN 992 mL/L 11056-001_9152f9e2-aeeb-43a8-980c-e735bd09bc70 11056-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19620101 UNAPPROVED MEDICAL GAS South Jersey Welding Supply OXYGEN 99 L/100L 11056-010_8ecbf417-2090-4517-abb8-e02582a54e4a 11056-010 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20100101 UNAPPROVED MEDICAL GAS South Jersey Welding Supply NITROGEN 99 L/100L 11084-017_7c1bda11-b9c7-4aa1-ad2f-3a101bcdced6 11084-017 HUMAN OTC DRUG InstantFOAM alcohol hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20080602 OTC MONOGRAPH NOT FINAL part333 Deb USA, Inc. ALCOHOL 72 mL/100mL 11084-020_0028140a-9c5f-48b2-b230-29b6eb279a5b 11084-020 HUMAN OTC DRUG Astound Antibacterial Triclosan LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mL/100mL 11084-040_a6650b96-9a5e-43e6-8bd4-a8d6d4c74815 11084-040 HUMAN OTC DRUG SBS 40 Allantoin LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part347 Deb USA, Inc. ALLANTOIN .5 mL/100mL 11084-042_49cc3124-4c50-41d7-9d72-ad30761c7b9b 11084-042 HUMAN OTC DRUG Cool Melon Allantoin CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part347 Deb USA, Inc. ALLANTOIN .5 mL/100mL 11084-050_398c87c2-15b0-4826-8cb2-273a6c581302 11084-050 HUMAN OTC DRUG Aerogreen Antibacterial Triclosan LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mL/100mL 11084-052_fb4b05a9-b90c-427b-9244-1d2994e4370b 11084-052 HUMAN OTC DRUG Bright Solutions Antibacterial Triclosan LIQUID TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mL/100mL 11084-053_38f523d6-7f8e-43e9-a044-fd62a8d66109 11084-053 HUMAN OTC DRUG AntiBac Foam Wash Triclosan, 0.30% LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mL/100mL 11084-054_0f853846-2a83-4f68-b251-1b9714fba870 11084-054 HUMAN OTC DRUG AgroBac Foam Wash Benzalkonium Chloride LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE 1.3 mL/100mL 11084-054_966f10e3-6f96-4e0b-9eb4-74dd132fd80c 11084-054 HUMAN OTC DRUG AgroBac Foam Wash Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE 1.3 mL/100mL 11084-057_dbb530e5-1e8e-464d-ad20-13ef30d75724 11084-057 HUMAN OTC DRUG InstantFOAM non-alcohol hand sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 11084-058_d68dd783-0c3e-4718-b9eb-bc7f6801448c 11084-058 HUMAN OTC DRUG InstantFOAM non-alcohol BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 11084-061_35a1c36f-2247-40e0-9c4c-221410452b3f 11084-061 HUMAN OTC DRUG DebMed Antimicrobial Body Wash and Shampoo Triclosan LIQUID TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .7 mL/100mL 11084-062_e3bdfdb4-5470-4904-81c7-7de8ef25e0e8 11084-062 HUMAN OTC DRUG Deb Med Antimicrobial Foaming Hand Wash Fresh Grapefruit Triclosan LIQUID TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .7 mL/100mL 11084-064_f1c99de9-c9d6-42aa-8035-24373229116b 11084-064 HUMAN OTC DRUG Deb Med Antimicrobial Foaming Hand Wash Cucumber Aloe Triclosan LIQUID TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .7 mL/100mL 11084-066_172bdf6b-3c8e-4bc0-9b0b-605d17302e96 11084-066 HUMAN OTC DRUG Deb Med Antimicrobial Foaming Hand Wash Fragrance Free Dye Free Triclosan LIQUID TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .7 mL/100mL 11084-068_0acec207-eb77-4173-a796-9dd52bd46a12 11084-068 HUMAN OTC DRUG Deb Med InstantFOAM Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 70 mL/100mL 11084-070_56a1cd23-abd5-4f82-a07a-1dec5b4bcb7e 11084-070 HUMAN OTC DRUG Aero IQ Antibacterial Quat Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE 1.3 mL/100mL 11084-071_1622775a-6d32-4b42-b6ab-c73acf3463fb 11084-071 HUMAN OTC DRUG Aero CleansE2 Antibacterial Chloroxylenol LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. CHLOROXYLENOL 2.1 mL/100mL 11084-075_deec68a9-d7ed-4180-8b44-1e6a76ccf3f6 11084-075 HUMAN OTC DRUG SBS UltraGreen Triclosan GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .15 mL/100mL 11084-076_e52d0550-98bf-4306-9b4c-0f216ed1e6d9 11084-076 HUMAN OTC DRUG Deb Gold Triclosan LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .15 mL/100mL 11084-077_dbd8fc97-dc99-4924-9cc2-8fde2c282c5e 11084-077 HUMAN OTC DRUG SBS UltraPink Triclosan GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .15 mL/100mL 11084-089_b746a878-24ad-464d-bc4a-59bc19659c06 11084-089 HUMAN OTC DRUG SBS Care Allantoin LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part347 Deb USA, Inc. ALLANTOIN .5 mL/100mL 11084-105_30ccaded-fba9-4dd2-95db-b66f36a2b44f 11084-105 HUMAN OTC DRUG Appeal Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mL/100mL 11084-106_596d61fa-d223-4987-b35d-11d4fb982418 11084-106 HUMAN OTC DRUG Appeal Non-Alcohol Foaming Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 11084-107_99e14748-b100-43db-88e0-64da9673eb3e 11084-107 HUMAN OTC DRUG Appeal Alcohol Foaming Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 70 mL/100mL 11084-109_ee7396e2-148c-4510-bb3b-70aa630a1276 11084-109 HUMAN OTC DRUG Deb InstantFOAM Alcohol Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 72 mL/100mL 11084-111_05aff63d-a288-4740-8a79-7bf86b6f88c3 11084-111 HUMAN OTC DRUG Chemstar InstantFOAM NonAlcohol Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL 11084-112_dbb530e5-1e8e-464d-ad20-13ef30d75724 11084-112 HUMAN OTC DRUG Drummond Aero Instant Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 11084-113_dbb530e5-1e8e-464d-ad20-13ef30d75724 11084-113 HUMAN OTC DRUG United Labs Instant Foam Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 11084-115_675bfd17-dfae-4e7d-bdac-41674b9e63d4 11084-115 HUMAN OTC DRUG Panache Antibacterial Body Wash Triclosan LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .55 mL/100mL 11084-116_59a50f19-4b23-4ff0-aaad-61b1c96bda17 11084-116 HUMAN OTC DRUG Deb Med Antibacterial Foam Hand Wash Triclosan LIQUID TOPICAL 20111215 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mL/100mL 11084-125_b9b86f6f-ab31-4cb5-a785-aa694e8db0bc 11084-125 HUMAN OTC DRUG AntiBac Foam Wash Triclosan LIQUID TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mL/100mL 11084-127_79d58125-18a2-4cb2-ae65-603cd141326f 11084-127 HUMAN OTC DRUG Deb Med Antimicrobial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL 11084-129_dbb530e5-1e8e-464d-ad20-13ef30d75724 11084-129 HUMAN OTC DRUG Safe-T-Fresh Alcohol Free Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 11084-130_8305ff75-5ba3-4fae-ad8a-11d02e5a4de9 11084-130 HUMAN OTC DRUG Aero Florafree Antibacterial Chloroxylenol LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. CHLOROXYLENOL .5 mL/100mL 11084-131_90e910b6-bf3e-4462-a17e-d6c45d85b44c 11084-131 HUMAN OTC DRUG PureBac Foam Wash Chloroxylenol LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. CHLOROXYLENOL .5 mL/100mL 11084-136_d68dd783-0c3e-4718-b9eb-bc7f6801448c 11084-136 HUMAN OTC DRUG Hy5 Soapopular Aero Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 11084-137_d68dd783-0c3e-4718-b9eb-bc7f6801448c 11084-137 HUMAN OTC DRUG Paragon Aero Instant Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 11084-138_ec998333-5772-4d68-b681-14922737f8b1 11084-138 HUMAN OTC DRUG Hy5 Alcohol Free Fragrance Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 11084-140_e48d761b-e343-4fb3-b20a-43b5f67109df 11084-140 HUMAN OTC DRUG SBS 41 Allantoin CREAM TOPICAL 20130101 OTC MONOGRAPH FINAL part347 Deb USA, Inc. ALLANTOIN 5 mg/mL 11084-141_43946563-05a2-4bf7-8042-f39b68ba8d85 11084-141 HUMAN OTC DRUG SBS 41 Medicated Cream Allantoin CREAM TOPICAL 20131101 OTC MONOGRAPH FINAL part347 Deb USA, Inc. ALLANTOIN 5 mg/mL 11084-147_14a72f7d-792f-4623-9b31-a0c189202c31 11084-147 HUMAN OTC DRUG Action Chemical Antibac Clear Triclosan LIQUID TOPICAL 20130912 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL 11084-148_ec2b9a73-4739-49d1-8fe5-e2a5dde16c98 11084-148 HUMAN OTC DRUG Deb Antimicrobial Fragrance and Dye Free Triclosan LIQUID TOPICAL 20130912 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL 11084-161_8d65f87f-7605-4423-8030-c6736f6d46aa 11084-161 HUMAN OTC DRUG Healthy Hands Foaming Instant Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 11084-175_163abc39-ff03-4651-8a6d-26dfaf6dcc47 11084-175 HUMAN OTC DRUG SBS UltraGreen Triclosan LIQUID TOPICAL 20130725 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN 1.5 mg/100mL 11084-177_5dd39fe4-0e41-4a7a-95e2-09f8f6fa66bf 11084-177 HUMAN OTC DRUG SBS UltraPink Triclosan LIQUID TOPICAL 20130725 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN 1.5 mg/100mL 11084-200_ed8e2b7b-bb06-4035-93c9-9b277bd60b99 11084-200 HUMAN OTC DRUG Deb Med InstantFOAM OptiDose Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 70 mL/100mL 11084-215_1566e1d7-98ea-4dba-8d8b-7c72046c74c3 11084-215 HUMAN OTC DRUG Panache Triclosan LIQUID TOPICAL 20130724 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .5 mg/100mL 11084-231_d34ead04-f52d-473d-86a8-89641ff4a4d2 11084-231 HUMAN OTC DRUG Deb PureBac Foam Wash Chloroxylenol LIQUID TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. CHLOROXYLENOL 5 mg/100mL 11084-232_ee9fe4cf-db6d-4439-b6f3-8f2a967acee4 11084-232 HUMAN OTC DRUG Clean Choice Antibacterial Chloroxylenol LIQUID TOPICAL 20130915 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. CHLOROXYLENOL 5 mg/100mL 11084-240_1f049e97-511b-4df0-83bd-b87d23b1481b 11084-240 HUMAN OTC DRUG SBS 40 Allantoin CREAM TOPICAL 20130101 OTC MONOGRAPH FINAL part347 Deb USA, Inc. ALLANTOIN 5 mg/100mL 11084-241_9ba15749-8a13-4bbe-9a96-e0496662c2c6 11084-241 HUMAN OTC DRUG SBS 40 Medicated Cream Allantoin CREAM TOPICAL 20131101 OTC MONOGRAPH FINAL part347 Deb USA, Inc. ALLANTOIN 5 mg/100mL 11084-253_691913fa-80dd-4c45-9ba9-ea1b38452b2d 11084-253 HUMAN OTC DRUG AntiBac Foam Wash/Aerogreen Triclosan LIQUID TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL 11084-254_f0f84a20-0635-4348-adbc-5c4cf820cb25 11084-254 HUMAN OTC DRUG Deb AgroBac Foam Wash Benzalkonium Chloride LIQUID TOPICAL 20130720 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mg/mL 11084-255_511562d8-9777-4a60-ac79-98fcb39c88e1 11084-255 HUMAN OTC DRUG Clean Choice Foodservice Antibacterial Benzalkonium Chloride LIQUID TOPICAL 20130720 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mg/mL 11084-262_4c5c6545-cd1a-4ac2-8fdd-58cec2af4a57 11084-262 HUMAN OTC DRUG Deb Med Antimicrobial Foaming Hand Wash Fresh Grapefruit Triclosan LIQUID TOPICAL 20130915 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN 7 mg/100mL 11084-266_d28978d9-c9ce-49c2-b903-658d59b02230 11084-266 HUMAN OTC DRUG Deb Med Antimicrobial Foaming Hand Wash Fragrance Free Dye Free Triclosan LIQUID TOPICAL 20130915 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN 7 mg/100mL 11084-532_acb42f75-13e6-46ef-8c10-dafa54a319b6 11084-532 HUMAN OTC DRUG AeroGreen Antibac Triclosan LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL 11084-533_57f72b24-0c1e-4144-97e4-e958826f763b 11084-533 HUMAN OTC DRUG Secure Antibac Triclosan LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL 11084-534_491dea25-8384-495e-ba85-c6323c9e8540 11084-534 HUMAN OTC DRUG Sentry Antibac Triclosan LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL 11084-535_e3b25827-4cd7-4b93-a11a-be49f7657543 11084-535 HUMAN OTC DRUG United Lab Antibac Triclosan LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL 11084-536_c7ee5461-f838-485b-ba33-e330d97e6901 11084-536 HUMAN OTC DRUG Pioneer Antibac Triclosan LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL 11084-537_0e217652-d86f-4ff5-a6f4-dcea7e281d48 11084-537 HUMAN OTC DRUG Delta Foremost Antibac Triclosan LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL 11084-538_a2bc23a9-3a49-477e-b6f0-0db0fec85caf 11084-538 HUMAN OTC DRUG Allegheny Antibac Triclosan LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL 11084-539_c590b65b-2061-4e24-aa51-2694b660ed13 11084-539 HUMAN OTC DRUG Chemstar Antibac Triclosan LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL 11084-575_2a0093b2-1f11-4cd9-af8b-79e6deabe218 11084-575 HUMAN OTC DRUG Ultragreen Antibacterial Triclosan LIQUID TOPICAL 20120620 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .15 g/100mL 11084-631_05ed6ede-c053-4204-8186-e8c9ef86d7a4 11084-631 HUMAN OTC DRUG Astound Antibac Triclosan LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL 11084-632_10964578-1363-496a-a103-f4f8eaeb613e 11084-632 HUMAN OTC DRUG DebMed Antimicrobial Triclosan LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL 11084-634_1a9b5a2b-7369-41a6-8ebf-4cb08e65db89 11084-634 HUMAN OTC DRUG Bright Solutions Antibac Triclosan LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL 11084-662_7cf60db2-046a-445b-8172-06da4e68f78d 11084-662 HUMAN OTC DRUG AntiBAC FH Pure FOAM Triclosan liquid LIQUID TOPICAL 20141113 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .7 g/mL 11084-700_bbb44c2b-a611-4102-98cd-ddb731cacf1d 11084-700 HUMAN OTC DRUG Deb InstantFoam Alcohol Sanitizer Ethyl Alcohol LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 70 mL/100mL 11084-701_f3bec7cb-d325-4014-a72a-866aad1b3627 11084-701 HUMAN OTC DRUG CTCA Foaming Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 70 mL/100mL 11084-702_87e0b7fb-f1d6-4ce0-be49-45a453d64452 11084-702 HUMAN OTC DRUG Appeal Alcohol Foaming Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 70 mL/100mL 11084-703_4b9b8237-2b32-4247-a33c-9c2b1845792c 11084-703 HUMAN OTC DRUG Deb InstantFoam Alcohol Sanitizer Ethyl Alcohol LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 70 L/100L 11084-704_9903a162-359e-4d12-9637-4695c8eaf46d 11084-704 HUMAN OTC DRUG Clean Choice Alcohol Sanitizer Ethyl Alcohol LIQUID TOPICAL 20130915 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 70 L/100L 11084-732_9ec1c1d7-dc61-459e-9b07-9a9b09398378 11084-732 HUMAN OTC DRUG Appeal Antibac Triclosan LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL 11086-011_061dad65-c4c5-0be7-e054-00144ff88e88 11086-011 HUMAN OTC DRUG TARSUM PROFESSIONAL COAL TAR SHAMPOO TOPICAL 20131030 OTC MONOGRAPH FINAL part358H Summers Laboratories Inc COAL TAR 2 g/100mL 11086-021_061d3abf-6b03-2043-e054-00144ff88e88 11086-021 HUMAN OTC DRUG TRIPLE MEDICATED FOR DIAPER RASH ZINC OXIDE PASTE TOPICAL 20131030 OTC MONOGRAPH FINAL part347 Summers Laboratories Inc ZINC OXIDE 12.8 g/100g 11086-022_061dad65-c4b2-0be7-e054-00144ff88e88 11086-022 HUMAN OTC DRUG REZAMID SULFUR AND RESORCINOL LOTION TOPICAL 20131030 OTC MONOGRAPH FINAL part333D Summers Laboratories Inc RESORCINOL; SULFUR 2; 5 1/100mL; g/100mL 11086-028_061d94ed-5e0d-334f-e054-00144ff88e88 11086-028 HUMAN OTC DRUG LIQUIMAT ACNE TREATMENT AND COVER-UP SULFUR LIQUID TOPICAL 20131030 OTC MONOGRAPH FINAL part333D Summers Laboratories Inc SULFUR 3 g/100mL 11086-030_061d94ed-5e05-334f-e054-00144ff88e88 11086-030 HUMAN PRESCRIPTION DRUG Keralyt salicylic acid GEL TOPICAL 20091101 UNAPPROVED DRUG OTHER Summers Laboratories Inc SALICYLIC ACID 6 g/100g 11086-032_061d94ed-5e35-334f-e054-00144ff88e88 11086-032 HUMAN PRESCRIPTION DRUG VANOXIDE HC BENZOYL PEROXIDE, HYDROCORTISONE LOTION TOPICAL 20091101 UNAPPROVED DRUG OTHER Summers Laboratories Inc BENZOYL PEROXIDE; HYDROCORTISONE 5; .5 g/100g; g/100g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 11086-037_061d94ed-5e29-334f-e054-00144ff88e88 11086-037 HUMAN PRESCRIPTION DRUG DRITHO-CREME HP ANTHRALIN CREAM TOPICAL 20130101 UNAPPROVED DRUG OTHER Summers Laboratories Inc ANTHRALIN 1 g/100g 11086-040_7bf69bac-4bc9-4cd8-8785-10f18b6ce5b5 11086-040 HUMAN OTC DRUG TRIPLE PASTE-AF MICONAZOLE NITRATE OINTMENT TOPICAL 20131030 OTC MONOGRAPH FINAL part333C Summers Laboratories Inc MICONAZOLE NITRATE 2 g/100g 11086-043_55632907-8757-11de-8a39-0800200c9a66 11086-043 HUMAN PRESCRIPTION DRUG Keralyt salicylic acid SHAMPOO TOPICAL 20091101 UNAPPROVED DRUG OTHER Summers Laboratories Inc SALICYLIC ACID 6 g/92.6mL 11086-047_74db36c0-bccb-11de-a3e0-0002a5d5c51b 11086-047 HUMAN PRESCRIPTION DRUG Keralyt salicylic acid KIT 20091101 UNAPPROVED DRUG OTHER Summers Laboratories Inc 11086-048_74db36c0-bccb-11de-a3e0-0002a5d5c51b 11086-048 HUMAN PRESCRIPTION DRUG Keralyt salicylic acid KIT 20091101 UNAPPROVED DRUG OTHER Summers Laboratories Inc 11086-051_061e4cfb-76ba-4957-e054-00144ff88e88 11086-051 HUMAN OTC DRUG Keralyt 5 salicylic acid GEL TOPICAL 20131030 COSMETIC Summers Laboratories Inc 11086-052_25471772-1829-4578-9440-72c5d3d96331 11086-052 HUMAN OTC DRUG KERALYT salicylic acid SHAMPOO TOPICAL 20131030 OTC MONOGRAPH FINAL part358H Summers Laboratories Inc SALICYLIC ACID 5 g/100mL 11096-001_4ada891b-86e0-7dfa-5d4a-3f67269a3e7b 11096-001 HUMAN OTC DRUG Vermocks Pyrantel Pamoate SUSPENSION ORAL 20120426 OTC MONOGRAPH FINAL part357B Tarmac Products, Inc. PYRANTEL PAMOATE 144 mg/mL 11096-190_017e5335-cec6-47fb-baf1-cee6a54c0bd5 11096-190 HUMAN OTC DRUG SANAFITIL Undecylenic Acid OINTMENT TOPICAL 19660824 OTC MONOGRAPH FINAL part333C Tarmac Products, Inc UNDECYLENIC ACID 100 mg/g 11103-001_66bcee01-2b66-45c9-a8a6-acc0501caf45 11103-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140101 NDA NDA205849 Temple Industrial Welding Supply Co OXYGEN 990 mL/L 11109-000_ad5ccc98-e70b-481e-986d-44aa47d170af 11109-000 HUMAN OTC DRUG THAYERS TOPICAL PAIN RELIEVER MEDICATED SUPERHAZEL with ALOE VERA FORMULA CAMPHOR LIQUID TOPICAL 20130918 OTC MONOGRAPH NOT FINAL part348 Henry Thayer Company CAMPHOR (NATURAL) 1 mg/mL 11109-001_c9bdfad6-0f4c-4574-b78f-238cda8a1dc4 11109-001 HUMAN OTC DRUG THAYERS TOPICAL PAIN RELIEVER SUPERHAZEL with ALOE VERA FORMULA CAMPHOR PATCH TOPICAL 20130918 OTC MONOGRAPH NOT FINAL part348 Henry Thayer Company CAMPHOR (NATURAL) .1 g/100g 11110-0001_a0bd0816-f284-4be7-9b1c-35a1c9fdb763 11110-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040923 UNAPPROVED MEDICAL GAS Alegent Health OXYGEN 99 L/100L 11118-1008_928bb17e-0386-42e7-a335-65e2e474b50b 11118-1008 HUMAN OTC DRUG SULPHO-LAC MEDICATED SULFUR SOAP TOPICAL 20070220 OTC MONOGRAPH FINAL part333 Bradford Soap Works, Inc. SULFUR 5 g/100g 11118-1023_8c7d67ee-53cf-4494-85ab-602188ff7667 11118-1023 HUMAN OTC DRUG CETAPHIL CETAPHIL SOAP TOPICAL 20070220 OTC MONOGRAPH NOT FINAL part333 Bradford Soap Works, Inc. TRICLOSAN .3 g/100g 11118-1030_8f6ee1cd-53f4-4512-91e0-a1f7e32a6493 11118-1030 HUMAN OTC DRUG AVEENO ACTIVE NATURALS AVEENO SOAP TOPICAL 20070220 OTC MONOGRAPH FINAL part333 Bradford Soap Works, Inc. SALICYLIC ACID .5 g/100g 11118-1100_b70178e4-b831-4430-aa05-cb460814a9ed 11118-1100 HUMAN OTC DRUG BASIS ALL CLEAR BAR BASIS SOAP TOPICAL 20070220 OTC MONOGRAPH NOT FINAL part333 Bradford Soap Works, Inc. TRICLOSAN .25 g/100g 11118-1102_6c1f3202-4692-49d4-b8b7-708602be8267 11118-1102 HUMAN OTC DRUG PALMERS SKIN SUCCESS TRICLOSAN SOAP TOPICAL 20070220 OTC MONOGRAPH NOT FINAL part333 Bradford Soap Works, Inc. TRICLOSAN .5 g/100g 11118-1103_8a80eb91-dc9b-4021-809e-25d5961de6d4 11118-1103 HUMAN OTC DRUG HOLYWOOD BEAUTY SULFUR SOAP TOPICAL 20070220 OTC MONOGRAPH FINAL part333 Bradford Soap Works, Inc. SULFUR 3 g/100g 11118-1104_f3456a56-c604-4361-a36a-b29dfb9e135f 11118-1104 HUMAN OTC DRUG MADINA AFRICAN BLACK SOAP TRICLOCARBAN SOAP TOPICAL 20070220 OTC MONOGRAPH NOT FINAL part333 Bradford Soap Works, Inc. TRICLOCARBAN .33 mg/100mg 11118-1106_2008e591-f9a8-4786-af49-f798b9400b4f 11118-1106 HUMAN OTC DRUG CUTICURA MEDICATED ANTIBACTERIAL BAR TRICLOCARBAN SOAP TOPICAL 20070220 OTC MONOGRAPH NOT FINAL part333 Bradford Soap Works, Inc. TRICLOCARBAN 1.5 mg/100mg 11118-1209_26456ef7-aa98-4881-aea9-8dfc617c1bc0 11118-1209 HUMAN OTC DRUG Proactive Solution Cleaning Bar SALICYLIC ACID SOAP TOPICAL 20100901 OTC MONOGRAPH FINAL part358H Bradford Soap Works, Inc. SALICYLIC ACID 1 g/100g 11118-3000_05ec905f-39de-4d23-9e6a-63f2279720bf 11118-3000 HUMAN OTC DRUG CUTICURA MEDICATED ANTIBACTERIAL BAR TRICLOCARBAN SOAP TOPICAL 20070220 OTC MONOGRAPH NOT FINAL part333 Bradford Soap Works, Inc. TRICLOCARBAN 1.5 mg/100mg 11291-070_27ebe620-1449-4e78-ae17-5136b3717c78 11291-070 HUMAN OTC DRUG Dr Tichenors First Aid Antispetic Alcohol GEL TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part333E Dr. G. H. Tichenor's Antiseptic Company ALCOHOL 7 mL/10mL 11291-243_b3191efa-fc07-4c04-88a6-3cb6b244f57f 11291-243 HUMAN OTC DRUG Dr Tichenors Toothpaste With Extra Whitening and Tartar Control Sodium Fluoride PASTE ORAL 20121024 OTC MONOGRAPH FINAL part355 Dr. G. H. Tichenor's Antiseptic Company SODIUM FLUORIDE 2.43 mg/g 11331-001_0e929bcb-6da3-4dbe-a169-5c12c08d0b27 11331-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091106 UNAPPROVED MEDICAL GAS American Welding & Gas OXYGEN 99 L/100L 11344-001_56218acc-c21e-4437-a5a5-ef2e9fac3c73 11344-001 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20141010 OTC MONOGRAPH FINAL part344 Sound Drug ISOPROPYL ALCOHOL 613 mg/mL 11344-002_145214d0-16e7-44f2-baa7-25345433e18b 11344-002 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333A Sound Body HYDROGEN PEROXIDE 30 mg/mL 11344-003_7d4f2951-3bb3-49bf-a935-3d6ef38105f2 11344-003 HUMAN OTC DRUG 50% Rubbing Isopropyl Alcohol LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333A Sound Body ISOPROPYL ALCOHOL 500 mg/mL 11344-053_0858d2da-09bb-432e-a1be-2324e47ade5f 11344-053 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20090105 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 545 mg/mL 11344-069_5c138373-7ef2-4151-8b7a-4014b639dd7c 11344-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 19890715 OTC MONOGRAPH FINAL part347 Vi-Jon PETROLATUM 1 g/g 11344-072_b9be94f9-8391-4ea5-9fc8-9a6fcbefe78e 11344-072 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20090815 OTC MONOGRAPH NOT FINAL part348 Vi Jon EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 11344-118_b005f26b-9bef-4a9f-a5d9-624861ef18b6 11344-118 HUMAN OTC DRUG Foaming Hand Sanitizer Benzalkonium Chloride LOTION TOPICAL 20090105 OTC MONOGRAPH NOT FINAL part333A Vi-Jon BENZALKONIUM CHLORIDE 1.3 mg/mL 11344-211_31c7b084-08fd-49bb-a94b-2667341555dd 11344-211 HUMAN OTC DRUG Isopropyl ISOPROPYL ALCOHOL LIQUID TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ISOPROPYL ALCOHOL 924 mg/mL 11344-234_f53adbf8-dcba-4431-a9d5-e1a7d7fe0651 11344-234 HUMAN OTC DRUG Germ-X Alcohol LIQUID TOPICAL 19990712 OTC MONOGRAPH NOT FINAL part333A Vi Jon, Inc ALCOHOL 63 mg/mL 11344-245_9c9b17a3-19ae-4190-9ed4-ea5b4afb287a 11344-245 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20090916 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 837 mg/mL 11344-269_9f22e806-22e1-4a9c-8942-f3af254d750b 11344-269 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20131004 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 545 mg/mL 11344-297_52940621-d386-442d-bc64-7863ae1a813f 11344-297 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140314 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 567 mg/mL 11344-318_defbe48f-2b1c-417e-9ccc-1e90988de31f 11344-318 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20010104 OTC MONOGRAPH NOT FINAL part356 Vi-Jon EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 11344-379_cb0140c7-2d3b-4247-a4d2-e22a48199f1b 11344-379 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 19921021 OTC MONOGRAPH NOT FINAL part348 Vi-Jon MENTHOL 1.5 mg/g 11344-410_95254737-6c2e-4e92-b50e-eba910861dcb 11344-410 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120130 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 585 mg/mL 11344-484_54fa4327-48bf-4b52-a0fc-cbd2dae76835 11344-484 HUMAN OTC DRUG Handi Sani ALCOHOL LIQUID TOPICAL 20120402 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 62 mL/100L 11344-538_d6f47167-da4f-4796-9fae-b2bb57fc921e 11344-538 HUMAN OTC DRUG Moisturizing Hand Sanitizer Ethyl alcohol GEL TOPICAL 20090105 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 558 mg/mL 11344-541_27db6dbd-7702-4bda-b1ce-53b3c1d438b4 11344-541 HUMAN OTC DRUG Antibacterial Liquid Hand TRICLOSAN LIQUID TOPICAL 20090730 OTC MONOGRAPH NOT FINAL part333A Vi Jon TRICLOSAN .115 kg/100L 11344-544_e151cda9-2c96-4448-981b-96a074abb156 11344-544 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140314 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 567 mg/mL 11344-554_3982d822-122c-4f68-a6ac-6a3a2a5f2be2 11344-554 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 545 mg/mL 11344-603_e627c69d-8fbf-4091-a6b2-a5791836c94a 11344-603 HUMAN OTC DRUG Hand Sanitizer ALCOHOL LOTION TOPICAL 20050419 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc ALCOHOL .073 mL/100L 11344-604_9c82ecfa-8f5e-489f-8898-6809b1b24dd0 11344-604 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140314 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 567 mg/mL 11344-616_de276c2b-5195-4dbf-aa0b-bb24f336891b 11344-616 HUMAN OTC DRUG Hand Sanitizer ALCOHOL LOTION TOPICAL 20050419 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc ALCOHOL .073 mL/100L 11344-626_4d414362-170b-4122-ac67-e4775f0796d3 11344-626 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20131004 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 545 mg/mL 11344-646_4b225001-ca41-42d4-8252-bc37674ca93a 11344-646 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140729 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 558 mg/mL 11344-663_133defb0-686d-479b-a9aa-58e31d948eef 11344-663 HUMAN OTC DRUG Crisp Apple Hand Sani Ethyl Alcohol LIQUID TOPICAL 20120130 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 585 g/mL 11344-697_70e8c2b5-d5f7-472a-b0f1-82020a424888 11344-697 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 558 mg/mL 11344-817_257aa52e-8d97-490d-a7bc-a07ac8c3f027 11344-817 HUMAN OTC DRUG Handi Sani ALCOHOL LIQUID TOPICAL 20120402 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 62 mL/100L 11344-905_2797f6e7-f81e-4662-9677-2b1688e87a97 11344-905 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140729 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 558 mg/mL 11344-919_929e07f2-4f79-4a7a-8757-331124fd3b77 11344-919 HUMAN OTC DRUG Soft wipes Benzalkonium chloride CLOTH TOPICAL 19981113 OTC MONOGRAPH NOT FINAL part333A Vi-Jon BENZALKONIUM CHLORIDE .13 mg/mL 11344-944_dfa35c2a-21b2-47e8-9ab3-90544dd03174 11344-944 HUMAN OTC DRUG Hand Sanitizer ALCOHOL LOTION TOPICAL 20050419 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc ALCOHOL .073 mL/100L 11344-961_9ef79e47-c008-4ecc-9576-fb19da92573f 11344-961 HUMAN OTC DRUG Handi Sani ALCOHOL LIQUID TOPICAL 20120402 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 62 mL/100L 11344-980_34797270-84ef-4b16-a936-8aad0399d73b 11344-980 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 545 mg/mL 11344-984_b02b0b3f-868a-41d4-a439-a0ff57e7d260 11344-984 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140314 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 567 mg/mL 11344-989_65b9fa6e-b330-44f7-b43e-5ce87c13541c 11344-989 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 545 mg/mL 11344-999_75dae112-fd26-408c-bc0d-24b156eb6d93 11344-999 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 545 mg/mL 11383-151_70453c76-7f71-4edb-9c67-3741dc21d1d1 11383-151 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20130517 ANDA ANDA091239 Weeks & Leo Co., Inc. IBUPROFEN 200 mg/1 11383-193_db72cf92-6ffd-4f2d-bc38-abcc787d0d08 11383-193 HUMAN OTC DRUG Bite and Itch Diphenhydramine HCl and Pramoxine HCl LOTION TOPICAL 20000106 OTC MONOGRAPH NOT FINAL part348 Weeks & Leo Co., Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 20; 10 mg/g; mg/g 11383-253_f39f4bfe-5d2b-490a-8db9-b0b670215611 11383-253 HUMAN OTC DRUG Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20110325 OTC MONOGRAPH FINAL part358G Weeks & Leo Co., Inc. PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 11383-257_5b04f51e-2b48-492b-84b1-22e988d46720 11383-257 HUMAN OTC DRUG Omeprazole Delayed Release Omeprazole TABLET, DELAYED RELEASE ORAL 20110712 NDA NDA022032 Weeks & Leo Co., Inc. OMEPRAZOLE 20 mg/1 11390-001_bc2499ca-7665-4592-9459-87f56409cadc 11390-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19970422 UNAPPROVED MEDICAL GAS Airgas Southwest, Inc. OXYGEN 990 mL/L 11390-004_9e57550d-2c9a-42fb-a276-a8580f6a5a00 11390-004 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20000720 UNAPPROVED MEDICAL GAS Airgas Southwest, Inc. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 11390-025_538fb9e2-2932-401f-bfd1-f870d16f5042 11390-025 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20000920 UNAPPROVED MEDICAL GAS Airgas Southwest, Inc. AIR 1000 mL/L 11399-005_ffa30998-ba45-4adb-a58e-b047acf0be12 11399-005 HUMAN PRESCRIPTION DRUG Fareston toremifene citrate TABLET ORAL 19970630 NDA NDA020497 GTx, Inc. TOREMIFENE CITRATE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 11401-6994_85aa9e5a-6458-47cf-b587-eaa024deeefb 11401-6994 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20041101 UNAPPROVED MEDICAL GAS Hawaii Home Infusion Associates, Ltd. OXYGEN 99 L/100L 11410-001_0efbb216-e584-4e72-965d-76f3c58d5884 11410-001 HUMAN OTC DRUG Proactiv Solution BB Broad Spectrum SPF 15 (Light, Medium, Dark) OCTINOXATE, OCTISALATE, and OXYBENZONE LOTION TOPICAL 20121201 OTC MONOGRAPH FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 3 g/100mL; mg/100mL; mg/100mL 11410-003_95ab6912-c84c-444f-8bef-53989eb3ffca 11410-003 HUMAN OTC DRUG X Out Cleansing Wipes For On The Go Blemish Treatment BENZOYL PEROXIDE SWAB TOPICAL 20121231 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.75 mg/1 11410-004_f5afe82f-2f7c-4bbc-801d-f76d70fe9649 11410-004 HUMAN OTC DRUG X Out Daily Body Scrub SALICYLIC ACID LOTION TOPICAL 20121231 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 2 g/100mL 11410-006_57eaad0a-1abf-410d-9654-251a75856d84 11410-006 HUMAN OTC DRUG X Out Spot Corrector SULFUR LOTION TOPICAL 20121231 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SULFUR 6 g/100mL 11410-007_3f824c70-fe77-4e57-8c03-de829a9edd86 11410-007 HUMAN OTC DRUG X Out Cleansing Body Bar SALICYLIC ACID SOAP TOPICAL 20121231 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 1 mg/100g 11410-008_4338d2be-2543-4d80-9f2b-e146d7c5e354 11410-008 HUMAN OTC DRUG Proactiv plus Skin Purifying Mask SULFUR LOTION TOPICAL 20121231 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SULFUR 6 g/100g 11410-009_2737a567-635f-4002-98b5-35b020b117f9 11410-009 HUMAN OTC DRUG Proactiv plus Pore Targeting Treatment BENZOYL PEROXIDE GEL TOPICAL 20130103 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.5 mg/100mL 11410-010_c93030df-7661-4688-9e2a-1355b6c8893c 11410-010 HUMAN OTC DRUG Proactiv Plus Complexion Perfecting Hydrator SALICYLIC ACID LOTION TOPICAL 20130301 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID .5 g/100mL 11410-011_c82a1fd2-b198-449f-bbdf-95fb8809aaea 11410-011 HUMAN OTC DRUG Proactivplus Skin Smoothing Exfoliator BENZOYL PEROXIDE LOTION TOPICAL 20130125 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.5 mg/100mL 11410-012_8e430eba-07e6-46c1-9eed-f65e8f696e8f 11410-012 HUMAN OTC DRUG Proactiv Plus Emergency Blemish Relief Benzoyl Peroxide CREAM TOPICAL 20130215 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 5 g/100g 11410-017_2c979299-2c65-4f8d-95b3-811f6dd10756 11410-017 HUMAN OTC DRUG Proactiv Solution Oil Free Moisture SPF 15 Moisturizer OCTINOXATE and ZINC OXIDE LOTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; ZINC OXIDE 7.5; 3 mg/100mL; mg/100mL 11410-018_96e95cb9-894c-4a07-b973-144d97178bac 11410-018 HUMAN OTC DRUG Proactiv Solution Blackhead Dissolving SALICYLIC ACID GEL TOPICAL 20130501 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID .5 g/100mL 11410-019_cc495788-ebf3-48eb-82e5-ed7e82415985 11410-019 HUMAN OTC DRUG Proactiv Revitalizing Toner Combination Therapy Acne Treatment SALICYLIC ACID LIQUID TOPICAL 20100801 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 2 mg/100mL 11410-020_c9ba6915-6cef-441c-a6e8-5b0fccab9020 11410-020 HUMAN OTC DRUG PRINCIPAL SECRET Reclaim Revolutionary Anti-Aging Day SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, and OCTOCRYLENE LOTION TOPICAL 20070817 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 7.5; 5; 2.75 mL/100mL; mL/100mL; mL/100mL; mL/100mL 11410-021_71b7c1c3-e593-4c2c-a721-1c1c82b0c16d 11410-021 HUMAN OTC DRUG Proactiv Solution Refining Mask Sulfur CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SULFUR 6 g/100g 11410-022_0b7bc0c6-c810-4054-8df9-de152d68f65f 11410-022 HUMAN OTC DRUG Meaningful Beauty Dark Spot Correcting Treatment HYDROQUINONE LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part358A Guthy-Renker LLC HYDROQUINONE 2 g/100mL 11410-027_da51516d-64cb-4474-a783-aa8887a5acd1 11410-027 HUMAN OTC DRUG Proactiv Plus Cleansing Body Bar SALICYLIC ACID SOAP TOPICAL 20130601 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 1 mg/100g 11410-036_fbec11fc-3f8c-4e57-8117-e3222fa335bb 11410-036 HUMAN OTC DRUG LASHappeal Eye Results with SPF 15 AVOBENZONE, OCTINOXATE, and OXYBENZONE LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC AVOBENZONE; OCTINOXATE; OXYBENZONE 3; 7.5; 5 mg/100mL; mg/100mL; mg/100mL 11410-044_9876ae73-e8b9-46a9-838d-ded28cf48f2a 11410-044 HUMAN OTC DRUG Proactiv Repairing Treatment Benzoyl Peroxide LOTION TOPICAL 20090330 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.5 mg/100mL 11410-086_2396d26b-fa41-448c-9692-9f484f9b6fb8 11410-086 HUMAN OTC DRUG Reclaim Radiance Concealer SPF15 Light to Medium TITANIUM DIOXIDE CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC TITANIUM DIOXIDE 956.25 mg/4.25g 11410-101_480df48a-dd10-47ed-882b-0a8d517d16fa 11410-101 HUMAN OTC DRUG Proactiv Concealer Plus SULFUR LOTION TOPICAL 19981201 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SULFUR 8 mg/100mL 11410-106_36b1844a-78dd-4869-ae69-0baee89d5c6a 11410-106 HUMAN OTC DRUG Principal Secret Reclaim Radiance Foundation SPF15 Medium Octinoxate and Oxybenzone CREAM TOPICAL 20090910 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OXYBENZONE 7.5; 3 mL/100mL; mL/100mL 11410-113_4c3f855e-1bf9-4000-9ec2-ca0487c4fc37 11410-113 HUMAN OTC DRUG Proactiv Solution Deep Cleansing Wash Salicylic Acid LOTION/SHAMPOO TOPICAL 20101001 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID .02 g/1000mL 11410-117_e639c3bb-d5dc-4ad3-bcab-b50b6100fd6a 11410-117 HUMAN OTC DRUG X-Out Wash-In Treatment Benzoyl Peroxide GEL TOPICAL 20110923 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 8.5 mg/100g 11410-121_341bf298-db6a-4fbd-9942-8bc8895ae2ae 11410-121 HUMAN OTC DRUG Principal Secret Reclaim Oil Control Hydrator SPF8 TITANIUM DIOXIDE LOTION TOPICAL 20070912 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC TITANIUM DIOXIDE 4 mL/100mL 11410-125_cc9e9305-f0bb-48bb-b259-3712277b245e 11410-125 HUMAN OTC DRUG Principal Secret Reclaim Radiance Foundation SPF15 Light Medium Octinoxate and OXYBENZONE CREAM TOPICAL 20090910 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OXYBENZONE 7.5; 3 mL/100mL; mL/100mL 11410-128_eb2630a1-67e6-4792-879c-6bf8961bcdec 11410-128 HUMAN OTC DRUG Proactiv Solution Medicated Cleansing Bar Salicylic Acid SOAP TOPICAL 20110101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 1 g/100g 11410-141_9745391d-61d7-4f65-b80f-e994a950fe8e 11410-141 HUMAN OTC DRUG Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 5 mg/100mL; mL/100mL; mL/100mL; mg/100mL 11410-150_6b1d062f-03bd-4aea-b4ce-fc87fdebb063 11410-150 HUMAN OTC DRUG Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAs Octinoxate, Oxybenzone, and Octisalate CREAM TOPICAL 20050426 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE .075; .035; .04 mL/mL; mL/mL; mg/mL 11410-160_6b1d062f-03bd-4aea-b4ce-fc87fdebb063 11410-160 HUMAN OTC DRUG Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAs Octinoxate, Oxybenzone, and Octisalate CREAM TOPICAL 20050426 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE .075; .035; .04 mL/mL; mL/mL; mg/mL 11410-162_171559ce-39ab-4a1d-bed1-e9383bc1cfa3 11410-162 HUMAN OTC DRUG Proactiv Soothing Scalp Treatment Antidandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20120301 OTC MONOGRAPH FINAL part358H Guthy-Renker LLC PYRITHIONE ZINC 1 mL/100mL 11410-201_27ff5bfd-4a86-4a2c-958d-83dfd2edab13 11410-201 HUMAN OTC DRUG Proactiv Clear Zone Body Pads SALICYLIC ACID CLOTH TOPICAL 20050101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID .036 g/1 11410-202_ee8e5504-1eb0-4d53-8f52-1c2b4900ef43 11410-202 HUMAN OTC DRUG Proactiv Gentle Formula Clarifying Day SALICYLIC ACID LOTION TOPICAL 20031201 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 2 mg/100mL 11410-206_a7c36675-5770-4076-8539-662e7855ea34 11410-206 HUMAN OTC DRUG Proactiv Sheer Tint Moisture SPF 15 OCTINOXATE, OCTISALATE, and OXYBENZONE LOTION TOPICAL 20020201 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 3 mL/100mL; mL/100mL; mg/100mL 11410-207_34b46efa-9e1c-4f50-a255-9342f713d640 11410-207 HUMAN OTC DRUG Proactiv Repairing Benzoyl Peroxide LOTION TOPICAL 20071025 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.5 mg/100mL 11410-210_e3e11236-a457-4cbe-95de-d77811ae9255 11410-210 HUMAN OTC DRUG Blemish Buster SULFUR LIQUID TOPICAL 20100511 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SULFUR 10 mL/100mL 11410-301_01d088e2-abc3-4fb0-aff4-def004150fcb 11410-301 HUMAN OTC DRUG Proactiv Clear Zone SALICYLIC ACID LOTION TOPICAL 20040101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 2 mg/100mL 11410-302_6b791c1d-b1c7-4d08-9f6e-2a0d6a3e282b 11410-302 HUMAN OTC DRUG Proactiv Extra Strength Formula Cleanser BENZOYL PEROXIDE CREAM TOPICAL 20031201 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 7 mg/100mL 11410-303_f1388680-1697-4f57-9329-683698dccb6f 11410-303 HUMAN OTC DRUG Proactiv Solution Extra Strength Formula Toner Acne Treatment Salicylic Acid LIQUID TOPICAL 20030101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 2 mg/100mL 11410-304_43dbac64-554a-4c07-adf9-f94fe374029a 11410-304 HUMAN OTC DRUG Proactiv Extra Strength Formula BENZOYL PEROXIDE LOTION TOPICAL 20031201 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 7 mg/100mL 11410-305_6b99088f-787e-4a2e-94e7-af702f65f14e 11410-305 HUMAN OTC DRUG Proactiv Gentle Formula Clearifying Night SALICYLIC ACID LOTION TOPICAL 20080301 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 1 mg/100mL 11410-309_af3df535-280a-45fc-94d2-670e577aed5b 11410-309 HUMAN OTC DRUG Proactiv Herbal Conditioning Treatment PYRITHIONE ZINC CREAM TOPICAL 19991201 OTC MONOGRAPH FINAL part358A Guthy-Renker LLC PYRITHIONE ZINC 3 mg/1000mL 11410-401_3219fe95-09ae-4a1d-b6af-a330390000a7 11410-401 HUMAN OTC DRUG Proactiv Advanced Blemish Treatment Benzoyl Peroxide CREAM TOPICAL 19990101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC. BENZOYL PEROXIDE .06 g/g 11410-402_5c022751-90b8-4a24-8cc6-9adb407fe15e 11410-402 HUMAN OTC DRUG Proactiv Clarifying Night Acne Treatment Salicylic Acid CREAM TOPICAL 20020101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 1 mg/100mL 11410-405_f93d0550-9d49-47d8-90c8-43e5d66ebfdd 11410-405 HUMAN OTC DRUG Proactiv Solution Daily Protection Plus Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 5; 7.5; 5; 5 mg/.1g; mg/.1g; mL/.1g; mg/.1g; mg/.1g 11410-406_e8e54be3-acfd-450c-9e67-415c4f05df18 11410-406 HUMAN OTC DRUG Proactiv Soothing Scalp Treatment Antidandruff PYRITHIONE ZINC SHAMPOO TOPICAL 19981201 OTC MONOGRAPH FINAL part358A Guthy-Renker LLC PYRITHIONE ZINC 1 mg/100mL 11410-407_4f19248d-ab3a-4ff8-bcd7-c939257e71aa 11410-407 HUMAN OTC DRUG Proactiv Pore Cleansing System SALICYLIC ACID SOLUTION TOPICAL 20050201 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 5 mg/1000mL 11410-408_cf9dca83-cfdf-481a-9148-a68856529718 11410-408 HUMAN OTC DRUG Proactiv Skin Lightening HYDROQUINONE LOTION TOPICAL 19980101 OTC MONOGRAPH FINAL part358A Guthy-Renker LLC HYDROQUINONE 2 mg/100mL 11410-409_e4ceb862-d396-499d-849c-280658f58890 11410-409 HUMAN OTC DRUG Proactiv Renewing Cleanser Benzoyl Peroxide CREAM TOPICAL 20090101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE .25 g/1000mL 11410-410_6f57ecff-79fa-4c17-89c4-03f6acbe2479 11410-410 HUMAN OTC DRUG Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAs Octinoxate, Oxybenzone, and Octisalate CREAM TOPICAL 20080508 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE .075; .035; .04 mL/mL; mL/mL; mg/mL 11410-411_55fd49ea-635d-41e4-b557-83fb894b200b 11410-411 HUMAN OTC DRUG Dr. Evans Oil-Free DEFENSE DAY TINTED MOISTURIZER SPF 55 Homosalate, Octisalate, Oxybenzone, Avobenzone, Octocrylene LIQUID TOPICAL 20110204 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker, LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 20; 60 uL/mL; uL/mL; uL/mL; uL/mL; uL/mL 11410-412_668321a0-1eb9-4843-abb7-f2856225e829 11410-412 HUMAN OTC DRUG Jane Seymour Oil-Free Tinted Moisturizer with SPF 55 Oxybenzone, Octocrylene, Octisalate, Avobenzone, Homosalate LIQUID TOPICAL 20110204 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker, LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 20; 60 uL/mL; uL/mL; uL/mL; uL/mL; uL/mL 11410-413_926f5193-628c-4adf-a14b-b90f1bdf101c 11410-413 HUMAN OTC DRUG Natural Advantage SPF 15 All Day Moisture with AHAs octinoxate, oxybenzone, octisalate CREAM TOPICAL 20091102 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE 75; 35; 40 uL/mL; uL/mL; uL/mL 11410-420_6f57ecff-79fa-4c17-89c4-03f6acbe2479 11410-420 HUMAN OTC DRUG Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAs Octinoxate, Oxybenzone, and Octisalate CREAM TOPICAL 20080508 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE .075; .035; .04 mL/mL; mL/mL; mg/mL 11410-501_b8a9ad8b-28f0-4c59-98d5-088437d53bb3 11410-501 HUMAN OTC DRUG Proactiv Gentle Formula Clarifying Cleanser Salicylic Acid CREAM TOPICAL 20030101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID .02 g/1000mL 11410-503_2bd4498b-12e6-47f7-9344-c44db3d9143a 11410-503 HUMAN OTC DRUG Daily Body Moisture Hydrating Complex SPF8 OCTINOXATE and OXYBENZONE LOTION TOPICAL 20050802 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OXYBENZONE 7.5; 1 mL/100mL; mL/100mL 11410-507_4bd2d761-cfdb-4df8-94f9-7cfffe4c610e 11410-507 HUMAN OTC DRUG Proactiv Refining Mask Sulfur CREAM TOPICAL 19981201 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SULFUR .06 g/g 11410-509_cb33c559-2256-4411-a299-53eaaf1f8cb9 11410-509 HUMAN OTC DRUG Proactiv Deep Cleansing Wash Salicylic Acid CREAM TOPICAL 20050101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID .02 g/1000mL 11410-528_fd0f472e-7cb9-4923-9292-76e9dad22ac0 11410-528 HUMAN OTC DRUG Susan Lucci Youthful Essence For Eyes Instant Smoothing Day Treatment SPF 15 Octinoxate, Oxybenzone, and Avobenzone CREAM TOPICAL 20080514 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC AVOBENZONE; OCTINOXATE; OXYBENZONE .03; .075; .05 mg/mL; mL/mL; mg/mL 11410-541_48c30b3c-7c9c-4371-a3b4-1443d9269a4d 11410-541 HUMAN OTC DRUG Principal Secret Advanced with Hydrospheres Continuous Moisture SPF8 Octinoxate and Octisalate CREAM TOPICAL 20020510 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE 7.5; 1 mg/.1g; mg/.1g 11410-564_34ad8721-c155-4e9b-98f7-8aee31b912c9 11410-564 HUMAN OTC DRUG Meaningful Beauty Cindy Crawford Maintenance 1 Daily Moisture SPF 8 OCTINOXATE and AVOBENZONE LOTION TOPICAL 20060501 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC AVOBENZONE; OCTINOXATE 3; 5 mg/100mL; mg/100mL 11410-600_83146098-44ff-4e56-8379-d48e24c97334 11410-600 HUMAN OTC DRUG Sheer Cover Pressed Mineral Foundation SPF 12 ZINC OXIDE POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC ZINC OXIDE 12 mg/.1g 11410-601_b87657e2-50b7-4401-93b0-def5ee2f2cb1 11410-601 HUMAN OTC DRUG Proactiv Solution Daily Protection Plus Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20110607 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 5; 7.5; 5; 5 mg/100g; mL/100g; mL/100g; mL/100g; mg/100g 11410-602_17cf5607-dd7f-4375-a698-b145cfcac43b 11410-602 HUMAN OTC DRUG Proactiv Solution Anti-Itch Scalp HYDROCORTISONE LIQUID TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part348 Guthy-Renker LLC. HYDROCORTISONE .28 mg/100mL 11410-603_1dbc86e6-d9bd-4b61-86cb-5879bd389e8b 11410-603 HUMAN OTC DRUG Proactiv SPF 15 Moisturizer OCTINOXATE and ZINC OXIDE LOTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; ZINC OXIDE 7.5; 3 mg/100mL; mg/100mL 11410-605_67671575-bd2a-4fe7-801c-a0e1ed3ba911 11410-605 HUMAN OTC DRUG Sheer Cover Mineral Foundation SPF-15 Buff ZINC OXIDE POWDER TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC ZINC OXIDE 12 mg/.1g 11410-606_67671575-bd2a-4fe7-801c-a0e1ed3ba911 11410-606 HUMAN OTC DRUG Sheer Cover Mineral Foundation SPF-15 Latte ZINC OXIDE POWDER TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC ZINC OXIDE 12 mg/.1g 11410-607_67671575-bd2a-4fe7-801c-a0e1ed3ba911 11410-607 HUMAN OTC DRUG Sheer Cover Mineral Foundation SPF-15 Nude ZINC OXIDE POWDER TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC ZINC OXIDE 12 mg/.1g 11410-608_67671575-bd2a-4fe7-801c-a0e1ed3ba911 11410-608 HUMAN OTC DRUG Sheer Cover Mineral Foundation SPF-15 Bisque ZINC OXIDE POWDER TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC ZINC OXIDE 12 mg/.1g 11410-609_67671575-bd2a-4fe7-801c-a0e1ed3ba911 11410-609 HUMAN OTC DRUG Sheer Cover Mineral Foundation SPF-15 Mocha ZINC OXIDE POWDER TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC ZINC OXIDE 12 mg/.1g 11410-610_33d789b9-0d60-46c9-8c42-eac7da1c7415 11410-610 HUMAN OTC DRUG Proactiv Solution Purifying Botanical Peel SALICYLIC ACID GEL TOPICAL 20120210 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID .5 mg/100mL 11410-611_58b711c9-e78c-4f3f-81f9-9dbbb08edc14 11410-611 HUMAN OTC DRUG Proactiv Solution Advanced Daily Oil Control SALICYLIC ACID LOTION TOPICAL 20120301 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID .5 mg/100mL 11410-612_67671575-bd2a-4fe7-801c-a0e1ed3ba911 11410-612 HUMAN OTC DRUG Sheer Cover Mineral Foundation SPF-15 Golden ZINC OXIDE POWDER TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC ZINC OXIDE 12 mg/.1g 11410-613_67671575-bd2a-4fe7-801c-a0e1ed3ba911 11410-613 HUMAN OTC DRUG Sheer Cover Mineral Foundation SPF-15 Almond ZINC OXIDE POWDER TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC ZINC OXIDE 12 mg/.1g 11410-614_67671575-bd2a-4fe7-801c-a0e1ed3ba911 11410-614 HUMAN OTC DRUG Sheer Cover Mineral Foundation SPF-15 Frost ZINC OXIDE POWDER TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC ZINC OXIDE 12 mg/.1g 11410-694_4558c407-3ae3-4951-9123-7db29a4abe1d 11410-694 HUMAN OTC DRUG Sheer Cover Nourishing Moisturizer SPF 15 OCTINOXATE, OCTISALATE, and OXYBENZONE LOTION TOPICAL 20061201 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 3 mL/100mL; mg/100mL; mg/100mL 11410-701_a507069c-33c6-437d-a26a-b2913d5ebe6c 11410-701 HUMAN OTC DRUG Proactiv Mild Exfoliating Peel SALICYLIC ACID GEL TOPICAL 20041201 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 5 mg/1000mL 11410-711_85277c02-6748-42c9-b769-9ade509eced9 11410-711 HUMAN OTC DRUG Proactiv Sheer Tint Moisture SPF 15 OCTINOXATE, OCTISALATE, and OXYBENZONE LOTION TOPICAL 20081101 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 3 mL/100mL; mL/100mL; mg/100mL 11410-749_0e620513-c4d8-4d0f-9eb6-350f8ebafe37 11410-749 HUMAN OTC DRUG In An Instant Daily Tinted Moisturizer SPF 15 Octinoxate, Octisalate, and Avobenzone CREAM TOPICAL 20071025 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC. AVOBENZONE; OCTINOXATE; OCTISALATE .02; .075; .05 mg/mL; mL/mL; mL/mL 11410-800_2d02fa6a-ea32-49ef-8f7b-78c6fa239c3e 11410-800 HUMAN OTC DRUG Meaningful Beauty Cindy Crawford Maintenance 1plus Daily Moisture SPF 20 UVA/UVB OCTISALATE, OXYBENZONE, OCTINOXATE, and ZINC OXIDE LOTION TOPICAL 20071101 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 5; 5; 5; 3 mg/100mL; mg/100mL; mg/100mL; mg/100mL 11410-801_ec659db6-a34f-45aa-8532-0ed34312b04f 11410-801 HUMAN OTC DRUG Sheer Cover Shade Adapting Mineral Foundation SPF-15 Medium ZINC OXIDE POWDER TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC ZINC OXIDE 12 mg/100mg 11410-802_ec659db6-a34f-45aa-8532-0ed34312b04f 11410-802 HUMAN OTC DRUG Sheer Cover Shade Adapting Mineral Foundation SPF-15 Tan ZINC OXIDE POWDER TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC ZINC OXIDE 12 mg/100mg 11410-803_ec659db6-a34f-45aa-8532-0ed34312b04f 11410-803 HUMAN OTC DRUG Sheer Cover Shade Adapting Mineral Foundation SPF-15 Dark ZINC OXIDE POWDER TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC ZINC OXIDE 12 mg/100mg 11410-804_ec659db6-a34f-45aa-8532-0ed34312b04f 11410-804 HUMAN OTC DRUG Sheer Cover Shade Adapting Mineral Foundation SPF-15 Light ZINC OXIDE POWDER TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC ZINC OXIDE 12 mg/100mg 11410-810_687b36cd-f3dc-48c3-b1b9-669f10d3caca 11410-810 HUMAN OTC DRUG Susan Lucci Youthful Essence Daily Protection Moisturizer Sunscreen SPF 15 OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20080601 OTC MONOGRAPH FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 2 mg/100mL; mg/100mL; mg/100mL 11410-812_e0690be7-ad05-4f72-95db-6548f59ef567 11410-812 HUMAN OTC DRUG Proactiv Clear Purifying Mask SULFUR GEL TOPICAL 20080201 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SULFUR 6 mg/100mL 11410-839_9d42fea4-9151-4bf3-b5bd-be07b1c7c242 11410-839 HUMAN OTC DRUG Ice Elements SPF 15 Moisturizer Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100224 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE .075; .05; .03 mL/mL; mL/mL; mg/mL 11410-901_7bd6ba71-47fc-4858-9bcb-52137f624920 11410-901 HUMAN OTC DRUG Proactiv Solution Renewing Cleanser Benzoyl Peroxide LOTION TOPICAL 20120201 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.5 mL/100mL 11410-904_c875e680-3559-4b51-80ec-56d2ad64d899 11410-904 HUMAN OTC DRUG Proactiv Solution Renewing Cleanser Benzoyl Peroxide GEL TOPICAL 20111021 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.5 mL/100mL 11410-906_e8730d62-0726-4a4f-bd4a-074a016c174d 11410-906 HUMAN OTC DRUG Proactiv Solution Repairing Treatment Benzoyl Peroxide GEL TOPICAL 20111101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.5 mL/100mL 11410-914_2e24a563-b520-42ee-9d67-3768f4d91b49 11410-914 HUMAN OTC DRUG Meaningful Beauty Cindy Crawford Antioxidant SPF 20 UVA/UVB AVOBENZONE, OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL 11410-920_ba5bdb57-0bbc-4414-888b-618707484b64 11410-920 HUMAN OTC DRUG Proactiv Repairing Treatment Benzoyl Peroxide LOTION TOPICAL 20100901 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.5 mg/100mL 11410-923_c894dc26-6668-43c8-a24a-b283dd1d9887 11410-923 HUMAN OTC DRUG Proactiv Renewing Cleanser Benzoyl Peroxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE .025 g/1000mL 11410-927_c894dc26-6668-43c8-a24a-b283dd1d9887 11410-927 HUMAN OTC DRUG Proactiv Renewing Cleanser Benzoyl Peroxide CREAM TOPICAL 20100801 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE .025 g/1000mL 11410-955_5adcadee-dff3-44b7-8b20-8cc106824608 11410-955 HUMAN OTC DRUG Proactiv Solution Repairing Treatment Benzoyl Peroxide GEL TOPICAL 20131101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.5 mg/100mL 11419-001_471e40de-d6be-42b2-b2a3-447efdd36388 11419-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19540101 UNAPPROVED MEDICAL GAS SheSham, Inc. T/A Wilson Supply OXYGEN 995 mL/L 11429-1001_27a86598-ccd4-4e1e-a77e-0fe61eae9cf6 11429-1001 HUMAN OTC DRUG FoamFresh Alco-Free Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140416 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company BENZALKONIUM CHLORIDE 1 mg/mL 11429-1002_5a798857-9e85-41e1-97c4-700cf373b5aa 11429-1002 HUMAN OTC DRUG FoamFresh E-2 Sanitizer Cleanser BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140226 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company BENZALKONIUM CHLORIDE 1.3 mg/mL 11429-1003_6c9b2995-c1df-4483-8eb7-58122b063b04 11429-1003 HUMAN OTC DRUG Alco Hand Sanitizer ALCOHOL GEL TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company ALCOHOL 70 mL/100mL 11429-1004_6e3c30ad-bb53-4e4c-9bcd-00d32179d289 11429-1004 HUMAN OTC DRUG FoamFresh Alco-Foam Hand Sanitizer Alcohol LIQUID TOPICAL 20140331 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company ALCOHOL 62 mL/100mL 11429-1005_6dbf5d89-79cf-41c6-89af-34148c54f21b 11429-1005 HUMAN OTC DRUG FoamFresh Antibacterial Hand Wash CHLOROXYLENOL LIQUID TOPICAL 20120928 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company CHLOROXYLENOL 2.5 mg/mL 11429-1006_f36633fe-f295-438e-a885-7e1286411f64 11429-1006 HUMAN OTC DRUG Lemon Drop Gentle Antiseptic CHLOROXYLENOL LIQUID TOPICAL 20140416 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company CHLOROXYLENOL 3 mg/mL 11429-1007_cacb43f0-2b35-4cdf-94e2-234dfb799106 11429-1007 HUMAN OTC DRUG Derma 1 Healthcare Hand Wash CHLOROXYLENOL LIQUID TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company CHLOROXYLENOL 4 mg/mL 11429-1008_e56c7abc-8858-4fb6-a7d6-a4e2ec6a3966 11429-1008 HUMAN OTC DRUG FoamFresh Healthcare Hand Wash CHLOROXYLENOL LIQUID TOPICAL 20140418 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company CHLOROXYLENOL 7.5 mg/mL 11429-1009_a30a64c2-0f5b-4be9-a571-d85f851327cb 11429-1009 HUMAN OTC DRUG Pink Antibacterial CHLOROXYLENOL LIQUID TOPICAL 20140409 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company CHLOROXYLENOL 3 mg/mL 11444-001_bff49ae3-b1f2-4fbd-be5e-9cfabd144f6c 11444-001 HUMAN OTC DRUG Absorbine Jr. Menthol LIQUID TOPICAL 19010101 20180228 OTC MONOGRAPH NOT FINAL part348 W. F. Young, Inc. MENTHOL .0127 g/mL 11444-157_79f6044f-1426-4952-b618-fe8659e38761 11444-157 HUMAN OTC DRUG Absorbine Jr Ultra Strength Pain Relieving Menthol PATCH TOPICAL 20000101 20151130 OTC MONOGRAPH NOT FINAL part348 W. F. Young, Inc. MENTHOL 6500 mg/8h 11444-185_89ffe1de-8d32-45ab-b2eb-b32c29a62368 11444-185 HUMAN OTC DRUG Absorbine Jr. Back Menthol PATCH TOPICAL 20050101 20160131 OTC MONOGRAPH NOT FINAL part348 W. F. Young, Inc. MENTHOL 5000 mg/8h 11444-234_a2f4ff23-0a48-49eb-9954-bc8b8d8f204e 11444-234 HUMAN OTC DRUG ABSORBINE JR MENTHOL CREAM TOPICAL 20120430 20150630 OTC MONOGRAPH NOT FINAL part348 W. F. YOUNG, INC. MENTHOL 2.5 g/100g 11446-188_302cae91-dd09-4d47-989d-702f00d31294 11446-188 HUMAN OTC DRUG Easy Menthol PATCH TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 Wong?s Pharmaceutical International MENTHOL 4 g/1 11489-056_bf5c3ef3-12ae-4270-8c6c-b5a9d75b7d78 11489-056 HUMAN OTC DRUG Botanics Daily Hand Therapy Sunscreen SPF 10 Octinoxate and Avobenzone CREAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE 1.5; 3 mL/75mL; mL/75mL 11489-057_2d9d5ee4-d733-40c9-a4c2-2d6107135a4d 11489-057 HUMAN OTC DRUG BOTANICS FACE RENEWAL SUNSCREEN SPF 15 OCTINOXATE AND AVOBENZONE CREAM TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE 1.5; 3 mL/50mL; mL/50mL 11489-059_43066658-0de0-47e2-95e7-b540d8344c74 11489-059 HUMAN OTC DRUG BOTANICS FACE LIFT FIRMING SUNSCREEN SPF 10 OCTINOXATE, AVOBENZONE AND OCTISALATE CREAM TOPICAL 20100222 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3.75; 1.25 mL/50mL; mL/50mL; mL/50mL 11489-060_873f9dcd-b423-41d7-8349-2d32cc831498 11489-060 HUMAN OTC DRUG Botanics Complexion Refining Day Moisture Sunscreen SPF 12 Octinoxate and Avobenzone LOTION TOPICAL 20100127 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE 2.25; 3.75 mL/75mL; mL/75mL 11489-061_4f934e55-0d31-4901-8c29-c779903e500a 11489-061 HUMAN OTC DRUG No7 Advanced Hydration Day Sunscreen SPF 12 Octinoxate and Avobenzone CREAM TOPICAL 20091203 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE 1.5; 2.5 mL/50mL; mL/50mL 11489-062_9c2f3b99-32b6-4dd9-9faf-d4c7d8a7f83c 11489-062 HUMAN OTC DRUG No7 Time Resisting Day Sunscreen SPF 12 Octinoxate and Avobenzone CREAM TOPICAL 20091208 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE 1.25; 2.5 mL/50mL; mL/50mL 11489-064_70998b82-8fab-4224-b366-065e62fe4a5c 11489-064 HUMAN OTC DRUG No7 Lifting and Firming Day Sunscreen SPF 8 Octinoxate, Avobenzone and Octisalate EMULSION TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3.75; 1 mL/50mL; mL/50mL; mL/50mL 11489-066_d9fb9ec5-37a2-4be3-a8fb-6864bb234f9f 11489-066 HUMAN OTC DRUG BOTANICS TRIPLE ACTION DAY MOISTURE SUNSCREEN SPF 15 OCTINOXATE AND AVOBENZONE CREAM TOPICAL 20100120 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE 1.5; 2.25 mL/50mL; mL/50mL 11489-067_66b3c3d3-ed07-41d1-aa58-9e09da24bdd9 11489-067 HUMAN OTC DRUG No7 Protect and Perfect Day Sunscreen SPF 15 Avobenzone , Octinoxate and Octisalate EMULSION TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3; 1.25 mL/50mL; mL/50mL; mL/50mL 11489-068_c3d2f3c2-c762-4d6d-9f32-5e6273666193 11489-068 HUMAN OTC DRUG No7 Protect and Perfect Hand Sunscreen SPF 15 Octinoxate, Avobenzone and Octisalate CREAM TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE; OCTISALATE 2.25; 5.625; 1.5 mL/75mL; mL/75mL; mL/75mL 11489-069_eff82fba-618b-4299-8245-919d41d08967 11489-069 HUMAN OTC DRUG No7 Rebalancing Day Fluid Sunscreen SPF 15 Octinoxate and Avobenzone and Ensulizole LOTION TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; ENSULIZOLE; OCTINOXATE 2; 2; 6 mL/100mL; mL/100mL; mL/100mL 11489-070_da043113-ae2c-4cc6-8fe9-bcba6baa3df5 11489-070 HUMAN OTC DRUG No7 Beautiful Skin Day Normal Oily Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 mL/50mL; mL/50mL; mL/50mL 11489-071_01be9574-b61d-4da4-99e4-14197eb09833 11489-071 HUMAN OTC DRUG No7 Beautiful Skin Day Normal Dry Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 mL/50mL; mL/50mL; mL/50mL 11489-072_a51c6e2a-b38f-4c79-bae5-ffb00e2b55d1 11489-072 HUMAN OTC DRUG No7 Beautiful Skin Day Dry Very Dry Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 mL/50mL; mL/50mL; mL/50mL 11489-073_cbfbd805-dfe9-4fa5-9e52-ad57341b9a4b 11489-073 HUMAN OTC DRUG No7 Beautiful Skin Oil Free Skin Protector All Skin Types SPF 25 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.75; 3.25 mL/50mL; mL/50mL; mL/50mL 11489-074_6d03e6c6-327b-406f-9093-656a9d9ce4e9 11489-074 HUMAN OTC DRUG No7 Protect and Perfect Day Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3; 1.25 mL/50mL; mL/50mL; mL/50mL 11489-075_45a761e9-5754-4011-b8c3-4f31fe74614c 11489-075 HUMAN OTC DRUG No7 Lift and Luminate Day Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octocrylene CREAM TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.5; 2.5; .5 mL/50mL; mL/50mL; mL/50mL 11489-076_adc57bae-ddcd-41e2-8319-a1ab88f869c0 11489-076 HUMAN OTC DRUG No7 Protect and Perfect Hand Cream Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE; OCTISALATE 2.25; 5.625; 1.5 mL/75mL; mL/75mL; mL/75mL 11489-077_0fbaa8b8-2137-423e-8f59-e2057d75e2cb 11489-077 HUMAN OTC DRUG No7 Protect and Perfect Intense Day Cream Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20121218 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g 11489-078_b4aa84e3-5ad6-44a4-83ed-f9784a63c608 11489-078 HUMAN OTC DRUG No7 Restore and Renew Day Sunscreen Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20121210 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g 11489-079_15261ca5-1211-4dc5-a35b-47057c94c5c1 11489-079 HUMAN OTC DRUG No7 Men Protect and Perfect Intense Moisturiser Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20121210 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2 g/50g; g/50g; g/50g 11489-080_d9325225-4f19-4cf5-92d3-f4cddcb7127c 11489-080 HUMAN OTC DRUG Botanics Hydrating Day All Bright Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20130114 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g 11489-081_cd9a29cc-a2d2-4eed-8da7-952777c2e94a 11489-081 HUMAN OTC DRUG Botanics Skin Calming Day Ultra Calm Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20130114 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g 11489-082_edb33106-2fa3-4db8-afd1-f8e3ae50606c 11489-082 HUMAN OTC DRUG Botanics Mattifying Day All Bright Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20130114 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g 11489-083_17993d11-7f25-46e9-8b3c-86c222ccb4a8 11489-083 HUMAN OTC DRUG Botanics Protecting Day Age Defense Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20130114 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g 11489-084_7f28428c-242d-4f93-98c1-d291185d5576 11489-084 HUMAN OTC DRUG Botanics Triple Age Renewal Day All Bright Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20130114 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g 11489-085_86082a4e-9654-40a2-8770-049bddd9703a 11489-085 HUMAN OTC DRUG No7 Protect and Perfect Intense Day Cream SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20140926 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g 11489-086_6aab8777-94fa-4268-858b-65f138a4b34e 11489-086 HUMAN OTC DRUG No7 Protect and Perfect Day Cream SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20140926 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g 11489-087_bbdd3150-7f98-4dc6-b231-1c483292084a 11489-087 HUMAN OTC DRUG No7 Lift and Luminite Day Cream SPF 15 Avobenzone,Octinoxate, Octocrylene CREAM TOPICAL 20140926 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.5; 2.5; .5 g/50g; g/50g; g/50g 11489-088_22646bda-8442-4bab-82cd-751ad4db46e4 11489-088 HUMAN OTC DRUG No7 Protect and Perfect Intense Day Cream SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20140804 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g 11489-090_09f902a8-396e-4174-ab58-1db608b1a030 11489-090 HUMAN OTC DRUG Botanics Protecting Day Age Defense Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g 11509-0001_7cdaa0d7-dc13-4a92-8a28-47bde51c6ed6 11509-0001 HUMAN OTC DRUG Cepacol Sore Throat Regular Strength menthol LOZENGE ORAL 20030728 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated MENTHOL 3 mg/1 11509-0003_0062f266-1a0a-46e7-8aa6-8cfcbf2fb3f3 11509-0003 HUMAN OTC DRUG Cepacol Sore Throat from Post Nasal Drip menthol LOZENGE ORAL 20030728 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated MENTHOL 4.5 mg/1 11509-0011_38509b77-ebd1-47f5-8349-62f2fc92c33a 11509-0011 HUMAN OTC DRUG Cepacol Sore Throat Maximum Numbing Cherry benzocaine and menthol LOZENGE ORAL 20030728 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 11509-0012_38509b77-ebd1-47f5-8349-62f2fc92c33a 11509-0012 HUMAN OTC DRUG Cepacol Sore Throat Maximum Numbing Honey Lemon benzocaine and menthol LOZENGE ORAL 20030728 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated BENZOCAINE; MENTHOL 15; 2.6 mg/1; mg/1 11509-0013_38509b77-ebd1-47f5-8349-62f2fc92c33a 11509-0013 HUMAN OTC DRUG Cepacol Sore Throat Maximum Numbing Citrus benzocaine and menthol LOZENGE ORAL 20030728 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated BENZOCAINE; MENTHOL 15; 2.1 mg/1; mg/1 11509-0014_38509b77-ebd1-47f5-8349-62f2fc92c33a 11509-0014 HUMAN OTC DRUG Cepacol Sore Throat Maximum Numbing Sugar Free Cherry benzocaine and menthol LOZENGE ORAL 20030728 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated BENZOCAINE; MENTHOL 15; 4 mg/1; mg/1 11509-0020_07b57a6c-4171-490b-a4eb-c61d527c377a 11509-0020 HUMAN OTC DRUG Cepacol Sore Throat Plus Cough benzocaine and dextromethorphan hydrobromide LOZENGE ORAL 20050728 OTC MONOGRAPH FINAL part341 Combe Incorporated BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 11509-0025_afa3437a-b785-4ca0-98e7-0323692d7efd 11509-0025 HUMAN OTC DRUG Cepacol Fizzlers benzocaine TABLET, ORALLY DISINTEGRATING ORAL 20090901 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated BENZOCAINE 6 mg/1 11509-0031_38509b77-ebd1-47f5-8349-62f2fc92c33a 11509-0031 HUMAN OTC DRUG Cepacol Sore Throat Maximum Numbing Sugar Free Cherry benzocaine and menthol LOZENGE ORAL 20030728 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated BENZOCAINE; MENTHOL 15; 4 mg/1; mg/1 11509-0040_0ec7eaee-d45c-4d05-84e1-d8fb5276511b 11509-0040 HUMAN OTC DRUG Cepacol Sore Throat Plus Coating benzocaine and pectin LOZENGE ORAL 20060831 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated BENZOCAINE; PECTIN 15; 5 mg/1; mg/1 11509-0054_88a75fc7-9bad-4bda-8d51-d2e3bc4b6c62 11509-0054 HUMAN OTC DRUG Cepacol Dual Relief benzocaine and glycerin SPRAY ORAL 20070901 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated BENZOCAINE; GLYCERIN .0508; .335 g/mL; g/mL 11509-0301_8a06f089-e3ea-4727-a789-2da6f21edd2c 11509-0301 HUMAN OTC DRUG Lanacane Anti Itch Original Strength benzocaine and benzethonium chloride CREAM TOPICAL 19971231 OTC MONOGRAPH NOT FINAL part348 Combe Incorporated BENZETHONIUM CHLORIDE; BENZOCAINE 2; 60 mg/g; mg/g 11509-0302_8a06f089-e3ea-4727-a789-2da6f21edd2c 11509-0302 HUMAN OTC DRUG Lanacane Anti Itch Original Strength benzocaine and benzethonium chloride CREAM TOPICAL 19971231 OTC MONOGRAPH NOT FINAL part348 Combe Incorporated BENZETHONIUM CHLORIDE; BENZOCAINE 2; 60 mg/g; mg/g 11509-0306_8a06f089-e3ea-4727-a789-2da6f21edd2c 11509-0306 HUMAN OTC DRUG Lanacane Anti Itch Maximum Strength benzocaine and benzethonium chloride CREAM TOPICAL 19971231 OTC MONOGRAPH NOT FINAL part348 Combe Incorporated BENZETHONIUM CHLORIDE; BENZOCAINE 2; 200 mg/g; mg/g 11509-0325_c5f17115-49ef-495f-81be-24edfe190934 11509-0325 HUMAN OTC DRUG Scalpicin Anti Itch Medication salicylic acid LIQUID TOPICAL 19940615 OTC MONOGRAPH FINAL part358 Combe Incorporated SALICYLIC ACID 30 mg/g 11509-0360_677f7070-e6b4-4259-9c47-c1458dbb09b6 11509-0360 HUMAN OTC DRUG Vagisil Anti Itch Original Strength Benzocaine and Resorcinol CREAM TOPICAL 19740801 OTC MONOGRAPH NOT FINAL part348 Combe Incorporated BENZOCAINE; RESORCINOL 50; 20 mg/g; mg/g 11509-0362_c5d0b435-6f64-4d0c-ac9a-9a205f727686 11509-0362 HUMAN OTC DRUG Vagisil Satin hydrocortisone acetate CREAM TOPICAL 20080415 OTC MONOGRAPH NOT FINAL part348 Combe Incorporated HYDROCORTISONE ACETATE 10 mg/g 11509-0372_677f7070-e6b4-4259-9c47-c1458dbb09b6 11509-0372 HUMAN OTC DRUG Vagisil Anti Itch Maximum Strength Benzocaine and Resorcinol CREAM TOPICAL 19740801 OTC MONOGRAPH NOT FINAL part348 Combe Incorporated BENZOCAINE; RESORCINOL 200; 30 mg/g; mg/g 11509-0375_a8500c39-5a01-4bcc-a1de-e5ac6875b345 11509-0375 HUMAN OTC DRUG Vagisil Medicated Wipes pramoxine hydrochloride CLOTH TOPICAL 20050628 OTC MONOGRAPH NOT FINAL part347 Combe Incorporated PRAMOXINE HYDROCHLORIDE 10 mg/g 11509-0376_a8500c39-5a01-4bcc-a1de-e5ac6875b345 11509-0376 HUMAN OTC DRUG Vagisil Medicated Wipes pramoxine hydrochloride CLOTH TOPICAL 20050628 OTC MONOGRAPH NOT FINAL part347 Combe Incorporated PRAMOXINE HYDROCHLORIDE 10 mg/g 11509-0381_1d87a0ce-43d3-4422-802c-593004d25c94 11509-0381 HUMAN OTC DRUG Lanacane Maximum Strength Anti Bacterial First Aid Spray benzocaine and benzethonium chloride SPRAY TOPICAL 19931227 OTC MONOGRAPH NOT FINAL part348 Combe Incorporated BENZETHONIUM CHLORIDE; BENZOCAINE 2; 200 mg/g; mg/g 11509-0411_00184845-b409-4bad-9867-e5efeb360f02 11509-0411 HUMAN OTC DRUG Odor Eaters Foot and Sneaker tolnaftate SPRAY TOPICAL 20010901 OTC MONOGRAPH FINAL part333 Combe Incorporated TOLNAFTATE 10 mg/g 11509-5400_2385efb0-0660-46aa-af76-1454c5d59142 11509-5400 HUMAN OTC DRUG Scalpicin Scalp Itch Medication Maximum Strength hydrocortisone LIQUID TOPICAL 19921215 OTC MONOGRAPH FINAL part348 Combe Incorporated HYDROCORTISONE 10 mg/g 11509-5402_d531eb52-0690-483f-a6a4-61e5f6a17ac8 11509-5402 HUMAN OTC DRUG Scalpicin Medicated Wipes pramoxine hydrochloride CLOTH TOPICAL 20090525 OTC MONOGRAPH NOT FINAL part348 Combe Incorporated PRAMOXINE HYDROCHLORIDE 10 mg/g 11523-0072_20ac0fca-e2cd-4683-9379-23005daf1607 11523-0072 HUMAN OTC DRUG Tinactin Tolnaftate AEROSOL, POWDER TOPICAL 19930923 OTC MONOGRAPH FINAL part333C MSD Consumer Care, Inc. TOLNAFTATE 10 mg/g 11523-0080_f0df1779-5c7f-41a6-9905-125c96f5a407 11523-0080 HUMAN OTC DRUG Chlor-Trimeton 4Hour Chlorpheniramine Maleate TABLET ORAL 19751231 OTC MONOGRAPH FINAL part341 MSD Consumer Care, Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 11523-0096_15340cc8-151a-409b-a7cc-05572174ddd1 11523-0096 HUMAN OTC DRUG A and D Original Lanolin and Petrolatum OINTMENT TOPICAL 20030604 OTC MONOGRAPH FINAL part347 MSD Consumer Care, Inc. LANOLIN; PETROLATUM 136.4; 469.9 mg/g; mg/g 11523-0096_3e8fb203-4e8f-49cb-9583-a628e7dca6ac 11523-0096 HUMAN OTC DRUG A and D Original Lanolin and Petrolatum OINTMENT TOPICAL 20091225 OTC MONOGRAPH FINAL part346 MSD Consumer Care, Inc. LANOLIN; PETROLATUM 136.4; 469.9 mg/g; mg/g 11523-0165_77e1abb2-01ab-49d0-807f-d8e0e0046cdb 11523-0165 HUMAN OTC DRUG Tinactin Tolnaftate AEROSOL, SPRAY TOPICAL 19930923 OTC MONOGRAPH FINAL part333C MSD Consumer Care, Inc. TOLNAFTATE 10 mg/g 11523-0259_38e247be-fecc-4d26-89ad-5969b4e62610 11523-0259 HUMAN OTC DRUG Mexsana Medicated Starch, Corn POWDER TOPICAL 19930923 OTC MONOGRAPH FINAL part347 MSD Consumer Care, Inc. STARCH, CORN 837 mg/g 11523-0404_9143a203-063b-42e4-a7b2-d36a47370b59 11523-0404 HUMAN OTC DRUG Solarcaine Lidocaine SPRAY TOPICAL 20120406 OTC MONOGRAPH NOT FINAL part348 MSD Consumer care, Inc. LIDOCAINE 5 mg/g 11523-0430_3ea42396-2d11-471a-aafa-683283aa0921 11523-0430 HUMAN OTC DRUG Solarcaine cool aloe Lidocaine hydrochloride GEL TOPICAL 20120313 OTC MONOGRAPH NOT FINAL part348 MSD Consumer care, Inc. LIDOCAINE HYDROCHLORIDE 5 mg/g 11523-0435_95660c1b-ad47-4059-a94e-b494934e2374 11523-0435 HUMAN OTC DRUG Coppertone ultraGUARD SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20.06; 100.3; 50.15; 50.15 mg/mL; mg/mL; mg/mL; mg/mL 11523-0444_61364974-99bf-4f79-b104-d06c6f3743e7 11523-0444 HUMAN OTC DRUG Tinactin Tolnaftate POWDER TOPICAL 19930923 OTC MONOGRAPH FINAL part333C MSD Consumer Care, Inc. TOLNAFTATE 10 mg/g 11523-0461_2ea7ab50-81f4-4f81-a470-fce79f6ce3e3 11523-0461 HUMAN OTC DRUG Coppertone Sport SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 19990521 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 19.98; 79.92; 49.95; 49.95 mg/mL; mg/mL; mg/mL; mg/mL 11523-0463_af6d6772-45a9-400b-bb1a-0e1ff8b111c6 11523-0463 HUMAN OTC DRUG Dr. Scholls Extra Thick Callus Removers Salicylic Acid DISC TOPICAL 19900814 OTC MONOGRAPH FINAL part358F MSD Consumer Care, Inc. SALICYLIC ACID 4 mg/1 11523-0464_7a8a9fc2-d27d-4f2e-9050-aebb20a73dcc 11523-0464 HUMAN OTC DRUG Dr. Scholls Corn/Callus Remover Salicylic Acid LIQUID TOPICAL 19900814 OTC MONOGRAPH FINAL part358F MSD Consumer Care, Inc. SALICYLIC ACID 1.7 mg/mL 11523-0465_ae18ea2c-d90a-4136-8834-33639081fd13 11523-0465 HUMAN OTC DRUG Dr. Scholls Callus Removers Salicylic Acid DISC TOPICAL 19900814 OTC MONOGRAPH FINAL part358F MSD Consumer Care, Inc. SALICYLIC ACID 4 mg/1 11523-0468_c63454ff-caa3-4ef0-83e2-16b6d209a614 11523-0468 HUMAN OTC DRUG Dr. Scholls Clear Away Wart Remover Ultra Thin Discs Salicylic Acid DISC TOPICAL 19900814 OTC MONOGRAPH FINAL part358B MSD Consumer Care, Inc. SALICYLIC ACID 4 mg/1 11523-0544_c75a5b1d-f274-469b-a880-f6586d3dd6e6 11523-0544 HUMAN OTC DRUG Lotrimin Antifungal Miconazole nitrate AEROSOL, POWDER TOPICAL 19930901 OTC MONOGRAPH FINAL part333C MSD Consumer care, Inc. MICONAZOLE NITRATE 20 mg/g 11523-0602_7149c33e-a39d-4008-b3cf-9d919c6edc6f 11523-0602 HUMAN OTC DRUG Coppertone Sport High Performance SPF 30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30.24; 100.8; 50.4; 100.8 mg/mL; mg/mL; mg/mL; mg/mL 11523-0620_9726830f-188c-47a2-acac-662159f60ae3 11523-0620 HUMAN OTC DRUG Dr. Scholls One Step Callus Removers Salicylic Acid PLASTER TOPICAL 19900814 OTC MONOGRAPH FINAL part358F MSD Consumer Care, Inc. SALICYLIC ACID 4 mg/1 11523-0627_a4b12369-2dbb-431d-953a-439ba0356753 11523-0627 HUMAN OTC DRUG Dr. Scholls Corn Removers Salicylic Acid DISC TOPICAL 19900814 OTC MONOGRAPH FINAL part358F MSD Consumer Care, Inc. SALICYLIC ACID 4 mg/1 11523-0629_e885a5ba-5b23-4549-bc9b-7bef91f26e8b 11523-0629 HUMAN OTC DRUG Dr. Scholls Ultra Thin Corn Removers Salicylic Acid DISC TOPICAL 19900814 OTC MONOGRAPH FINAL part358F MSD Consumer Care, Inc. SALICYLIC ACID 4 mg/1 11523-0631_2ea6f9b7-928f-45cf-add0-77bf984f5f01 11523-0631 HUMAN OTC DRUG Dr. Scholls Clear Away Wart Remover Plantar salicylic acid DISC TOPICAL 19900814 OTC MONOGRAPH FINAL part358B MSD Consumer Care, Inc. SALICYLIC ACID 4 mg/1 11523-0635_70db139e-53d1-4d45-93d1-05c1c8293f5d 11523-0635 HUMAN OTC DRUG DuoFilm Wart Remover Salicylic Acid LIQUID TOPICAL 19900814 OTC MONOGRAPH FINAL part358B MSD Consumer Care, Inc. SALICYLIC ACID 150.28 mg/mL 11523-0728_7807d6bb-86a9-4eea-8a8e-053eebd16a83 11523-0728 HUMAN OTC DRUG Chlor-Trimeton 12 Hour Chlorpheniramine Maleate TABLET, EXTENDED RELEASE ORAL 20100104 NDA NDA007638 Schering Plough HealthCare Products CHLORPHENIRAMINE MALEATE 12 mg/1 11523-0753_46823a59-8928-4346-8395-d5a991634021 11523-0753 HUMAN OTC DRUG Dr. Scholls One Step Corn Removers Salicylic Acid PLASTER TOPICAL 19900814 OTC MONOGRAPH FINAL part358F MSD Consumer Care, Inc. SALICYLIC ACID 4 mg/1 11523-0771_58808da4-d1c5-45ce-9006-dfe0df1b2f8b 11523-0771 HUMAN OTC DRUG Gyne-Lotrimin 3 Clotrimazole CREAM VAGINAL 20020101 NDA NDA021143 MSD Consumer Care, Inc. CLOTRIMAZOLE 2 g/100g 11523-0777_4deb4f21-eb5e-4545-b177-16ea7a40211c 11523-0777 HUMAN OTC DRUG Tinactin Tolnaftate AEROSOL, POWDER TOPICAL 19930923 OTC MONOGRAPH FINAL part333C MSD Consumer Care, Inc. TOLNAFTATE 10 mg/g 11523-0883_536fa511-3c24-4c47-90c1-46aea70eadd1 11523-0883 HUMAN OTC DRUG Dr. Scholls For Her Cracked Skin Repair Dimethicone CREAM TOPICAL 20030604 OTC MONOGRAPH FINAL part347 MSD Consumer Care, Inc. DIMETHICONE 15 mg/g 11523-0887_f1f4be07-4bd0-4058-85e8-8647b748217b 11523-0887 HUMAN OTC DRUG Gyne-Lotrimin 7 Clotrimazole CREAM VAGINAL 20020101 ANDA ANDA072641 MSD Consumer Care, Inc. CLOTRIMAZOLE 1 g/100g 11523-0919_67d8c8b1-4bf4-424e-b932-027167f746d7 11523-0919 HUMAN OTC DRUG Lotrimin Antifungal Miconazole nitrate POWDER TOPICAL 19930901 OTC MONOGRAPH FINAL part333C MSD Consumer care, Inc. MICONAZOLE NITRATE 20 mg/g 11523-0934_72568326-2f56-4316-9c4c-ab84beea18d0 11523-0934 HUMAN OTC DRUG Tinactin Tolnaftate CREAM TOPICAL 19930923 OTC MONOGRAPH FINAL part333C MSD Consumer Care, Inc. TOLNAFTATE 10 mg/g 11523-0963_9216b717-c29b-407f-ae74-6ee949c84376 11523-0963 HUMAN OTC DRUG Lotrimin Clotrimazole CREAM TOPICAL 20020201 OTC MONOGRAPH FINAL part333C MSD Consumer Care, Inc. CLOTRIMAZOLE 10 mg/g 11523-1125_c0909685-25cc-43a8-8d80-62c4bd3471f4 11523-1125 HUMAN OTC DRUG Lotrimin Antifungal Clotrimazole CREAM TOPICAL 20020201 OTC MONOGRAPH FINAL part333C MSD Consumer care, Inc. CLOTRIMAZOLE 10 mg/g 11523-1159_a28d4eda-7755-482e-8cd3-a5bee91a5b2e 11523-1159 HUMAN OTC DRUG Afrin Original Pump Mist Oxymetazoline hydrochloride SPRAY, METERED NASAL 19750714 OTC MONOGRAPH FINAL part341 MSD Consumer Care, Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 11523-1167_896fd2cd-0a8f-47b6-b882-787bf33b264c 11523-1167 HUMAN OTC DRUG Afrin Original Oxymetazoline hydrochloride SPRAY NASAL 19750714 OTC MONOGRAPH FINAL part341 MSD Consumer Care, Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 11523-1190_d2caeef3-3649-41ad-ae36-be414aa9659e 11523-1190 HUMAN OTC DRUG Tinactin Tolnaftate CREAM TOPICAL 19930923 OTC MONOGRAPH FINAL part333C MSD Consumer Care, Inc. TOLNAFTATE 10 mg/g 11523-1272_f5786a1f-bb8e-4492-bd3e-1cbadc595c2b 11523-1272 HUMAN OTC DRUG Lotrimin Antifungal Miconazole nitrate AEROSOL, POWDER TOPICAL 19930901 OTC MONOGRAPH FINAL part333C MSD Consumer care, Inc. MICONAZOLE NITRATE 20 mg/g 11523-1305_59847e3d-f900-4b26-839a-6120e82ea8ca 11523-1305 HUMAN OTC DRUG Coricidin HBP Maximum Strength Flu Acetaminophen, Chlorpheniramine maleate, and Dextromethorphan Hydrobromide TABLET, FILM COATED ORAL 20000831 OTC MONOGRAPH FINAL part341 MSD Consumer Care, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 500; 2; 15 mg/1; mg/1; mg/1 11523-1314_fa90d773-50aa-4ca5-8799-c3ee58fd82f2 11523-1314 HUMAN OTC DRUG A and D Dimethicone and Zinc Oxide CREAM TOPICAL 20091225 OTC MONOGRAPH FINAL part347 MSD Consumer Care, Inc. DIMETHICONE; ZINC OXIDE 11.09; 110.09 mg/g; mg/g 11523-1350_f1a9c140-5d2d-406f-a8b2-cf091670367a 11523-1350 HUMAN OTC DRUG Afrin No Drip Severe Congestion Oxymetazoline hydrochloride SPRAY, METERED NASAL 20000831 OTC MONOGRAPH FINAL part341 MSD Consumer Care, Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 11523-1527_a6e7c60c-1fdd-4f06-b983-009494339a14 11523-1527 HUMAN OTC DRUG Claritin Loratadine TABLET ORAL 19930412 NDA NDA019658 MSD Consumer Care, Inc. LORATADINE 10 mg/1 11523-1702_b9a165e7-2f53-41a7-8925-42e47b8d306e 11523-1702 HUMAN OTC DRUG Afrin No Drip Sinus Pump Mist Oxymetazoline hydrochloride SPRAY, METERED NASAL 20000831 OTC MONOGRAPH FINAL part341 MSD Consumer Care, Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 11523-1783_eda61fb1-1b1f-40d5-b9d2-883c4677f874 11523-1783 HUMAN OTC DRUG Afrin No Drip Extra Moisturizing Oxymetazoline hydrochloride SPRAY, METERED NASAL 20000831 OTC MONOGRAPH FINAL part341 MSD Consumer Care, Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 11523-3142_04434ac1-4d92-4dbc-aed8-855124026d12 11523-3142 HUMAN OTC DRUG Afrin No Drip Original Pump Mist Oxymetazoline hydrochloride SPRAY, METERED NASAL 19990831 OTC MONOGRAPH FINAL part341 MSD Consumer Care, Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 11523-3601_97d99cb7-94b5-48c7-bbf5-4d8da9ad3645 11523-3601 HUMAN OTC DRUG Coricidin HBP Cough and Cold Cough Suppressant, Antihistamine Chlorpheniramine maleate and Dextromethorphan hydrobromide TABLET, FILM COATED ORAL 20100401 20150130 OTC MONOGRAPH FINAL part341 MSD Consumer Care, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 11523-4112_717b2057-270c-45fd-a417-f59d05e010f5 11523-4112 HUMAN OTC DRUG Afrin Sinus Oxymetazoline hydrochloride SPRAY NASAL 19960830 OTC MONOGRAPH FINAL part341 MSD Consumer Care, Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 11523-4140_a32243f7-152a-412d-bef5-fe93435950ab 11523-4140 HUMAN OTC DRUG Lotrimin Antifungal Miconazole nitrate AEROSOL, POWDER TOPICAL 19930901 OTC MONOGRAPH FINAL part333C MSD Consumer care, Inc. MICONAZOLE NITRATE 20 mg/g 11523-4161_826cc255-d559-4e55-82b9-f1a01aba3f90 11523-4161 HUMAN OTC DRUG Tinactin Antifungal Tolnaftate AEROSOL, POWDER TOPICAL 20111001 OTC MONOGRAPH FINAL part333C MSD Consumer Care, Inc. TOLNAFTATE 10 mg/g 11523-4162_c367e725-fa3b-47a4-8a66-7cb22d59cbdf 11523-4162 HUMAN OTC DRUG Tinactin Antifungal Tolnaftate AEROSOL, POWDER TOPICAL 20140228 OTC MONOGRAPH FINAL part333C MSD Consumer Care, Inc. TOLNAFTATE 10 mg/g 11523-4311_ab8d1f88-4d6e-42d4-b871-171d83f884b5 11523-4311 HUMAN OTC DRUG Oxytrol For Women oxybutynin PATCH TRANSDERMAL 20130819 NDA NDA202211 MSD Consumer Care, Inc. OXYBUTYNIN 3.9 mg/d 11523-4322_ab8d1f88-4d6e-42d4-b871-171d83f884b5 11523-4322 HUMAN OTC DRUG Oxytrol For Women oxybutynin PATCH TRANSDERMAL 20130819 NDA NDA202211 MSD Consumer Care, Inc. OXYBUTYNIN 3.9 mg/d 11523-4325_f3cebf05-9fbb-4393-b737-12f82064b7bb 11523-4325 HUMAN OTC DRUG Coricidin HBP Cold and Flu Acetaminophen and Chlorpheniramine maleate TABLET, FILM COATED ORAL 20131001 OTC MONOGRAPH FINAL part341 MSD Consumer Care, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 325; 2 mg/1; mg/1 11523-4326_35bac08e-5d3d-4bc2-af56-0385f4f4a27b 11523-4326 HUMAN OTC DRUG Coricidin HBP Cough and Cold Cough Suppressant, Antihistamine Chlorpheniramine maleate and Dextromethorphan hydrobromide TABLET, FILM COATED ORAL 20130501 OTC MONOGRAPH FINAL part341 MSD Consumer Care, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 11523-4327_b98bc491-1db6-42f9-8057-6a69120a180d 11523-4327 HUMAN OTC DRUG Lotrimin AF Antifungal Miconazole nitrate SPRAY TOPICAL 20130930 OTC MONOGRAPH FINAL part333C MSD Consumer care, Inc. MICONAZOLE NITRATE 20 mg/g 11523-4328_1c13d4a6-3697-4460-b0d2-72b43fd09217 11523-4328 HUMAN OTC DRUG Claritin Loratadine TABLET, CHEWABLE ORAL 20060823 NDA NDA021891 MSD Consumer Care, Inc. LORATADINE 5 mg/1 11523-4329_40f7ee7e-4d2a-4019-b503-ff4d7c9207ef 11523-4329 HUMAN OTC DRUG Claritin Reditabs Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20021127 NDA NDA020704 MSD Consumer Care, Inc. LORATADINE 10 mg/1 11523-4332_cafec592-721b-47db-a05b-9ef112027ffe 11523-4332 HUMAN OTC DRUG Claritin-D 24 Hour Loratadine and pseudoephedrine sulfate TABLET, EXTENDED RELEASE ORAL 20091201 NDA NDA020470 MSD Consumer Care, Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 11523-4335_ed53bcab-7274-4a92-a107-e0da3bb4bed9 11523-4335 HUMAN OTC DRUG Correctol Bisacodyl TABLET, COATED ORAL 20140731 OTC MONOGRAPH NOT FINAL part334 MSD Consumer Care, Inc. BISACODYL 5 mg/1 11523-4336_39dc645a-002a-4747-8aaf-7db6fd49c124 11523-4336 HUMAN OTC DRUG Dr. Scholls Odor-X Foot and Sneaker Tolnaftate AEROSOL, POWDER TOPICAL 19930923 OTC MONOGRAPH FINAL part333C MSD Consumer Care, Inc. TOLNAFTATE 10 mg/g 11523-4357_025c2b9f-bd54-4613-8cb5-82a612d6c1a1 11523-4357 HUMAN OTC DRUG MiraLAX Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20090223 NDA NDA022015 MSD Consumer Care, Inc. POLYETHYLENE GLYCOL 3350 17 g/17g 11523-4359_a6e7c60c-1fdd-4f06-b983-009494339a14 11523-4359 HUMAN OTC DRUG Claritin Loratadine TABLET ORAL 19930412 NDA NDA019658 MSD Consumer Care, Inc. LORATADINE 10 mg/1 11523-4765_73a00a6e-31dc-4e3f-be8d-c6f5312f1f8d 11523-4765 HUMAN OTC DRUG Coricidin HBP Day and Night Dextromethorphan Hydrobromide, Guaifenesin, Acetaminophen, Chlorpheniramine maleate KIT 20090829 OTC MONOGRAPH FINAL part341 MSD Consumer Care, Inc. 11523-6549_5313f652-3dd3-4bea-aa5e-b6362118e9b6 11523-6549 HUMAN OTC DRUG Lotrimin Clotrimazole CREAM TOPICAL 20090102 OTC MONOGRAPH FINAL part333C MSD Consumer Care, Inc. CLOTRIMAZOLE 10 mg/g 11523-6655_7efedf39-51a1-423f-9158-2b7a7d0a9a65 11523-6655 HUMAN OTC DRUG Claritin Loratadine TABLET ORAL 19930412 NDA NDA019658 MSD Consumer Care, Inc. LORATADINE 10 mg/1 11523-7020_44e19b24-3627-4047-b526-ad45264255ad 11523-7020 HUMAN OTC DRUG Afrin Severe Congestion Oxymetazoline hydrochloride SPRAY NASAL 20000831 OTC MONOGRAPH FINAL part341 MSD Consumer Care, Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 11523-7053_6aa4d566-c1ee-4500-a965-d7265b779270 11523-7053 HUMAN OTC DRUG Coppertone Sport Sunscreen Lip Balm SPF 30 avobenzone, octisalate, octocrylene, and oxybenzone STICK TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 30; 90.9; 50 mg/g; mg/g; mg/g; mg/g 11523-7054_b1c56f87-0eec-416c-9274-ffc3a1b755e5 11523-7054 HUMAN OTC DRUG Coppertone ultraGUARD SPF 30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30.24; 100.8; 50.4; 100.8 mg/mL; mg/mL; mg/mL; mg/mL 11523-7061_df1c625f-5286-4918-a054-f453b32086a9 11523-7061 HUMAN OTC DRUG Coppertone oil free SPF 30 avobenzone, homosalate, octisalate, octocrylene, and oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20.7; 134.55; 51.75; 20.7; 41.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7094_dcfd8dff-afd0-4fe3-8688-40c1a91ded1c 11523-7094 HUMAN OTC DRUG Bain de Soleil Mega Tan SPF 4 Octinoxate and Octocrylene LOTION TOPICAL 19990521 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. OCTINOXATE; OCTOCRYLENE 35; 10 mg/mL; mg/mL 11523-7141_eb9d3b36-7a58-4e2c-9232-5aa452957692 11523-7141 HUMAN OTC DRUG Coppertone oil free faces Sunscreen SPF 30 avobenzone, homosalate, octisalate, octocrylene, and oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20.7; 134.55; 51.75; 20.7; 41.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7143_3bb7f1ca-0879-4291-a52e-ac03c3b10ddf 11523-7143 HUMAN OTC DRUG Coppertone KIDS SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.76; 85.88; 42.94; 17.17; 34.35 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7154_c1ec7cab-47bb-4def-b764-e8463ab67ea5 11523-7154 HUMAN OTC DRUG Lotrimin Ultra Antifungal Butenafine Hydrochloride CREAM TOPICAL 19930923 NDA NDA021307 MSD Consumer Care, Inc. BUTENAFINE HYDROCHLORIDE 10 mg/g 11523-7155_68f48a31-0528-4182-9897-5090a0475dc8 11523-7155 HUMAN OTC DRUG Lotrimin Ultra Jock Itch Antifungal Butenafine Hydrochloride CREAM TOPICAL 19930923 NDA NDA021307 MSD Consumer Care, Inc. BUTENAFINE HYDROCHLORIDE 10 mg/g 11523-7157_40f7ee7e-4d2a-4019-b503-ff4d7c9207ef 11523-7157 HUMAN OTC DRUG Claritin Reditabs Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20021127 NDA NDA020704 MSD Consumer Care, Inc. LORATADINE 10 mg/1 11523-7158_3e0e1b88-c854-4b4a-b6b4-f4456f0af7bd 11523-7158 HUMAN OTC DRUG Coricidin HBP Chest Congestion And Cough Dextromethorphan hydrobromide and Guaifenesin CAPSULE, GELATIN COATED ORAL 20000831 OTC MONOGRAPH FINAL part341 MSD Consumer Care, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/1; mg/1 11523-7160_a6e7c60c-1fdd-4f06-b983-009494339a14 11523-7160 HUMAN OTC DRUG Claritin Loratadine TABLET ORAL 19930412 NDA NDA019658 MSD Consumer Care, Inc. LORATADINE 10 mg/1 11523-7161_e225144b-e9d6-439f-8785-01bdb350a080 11523-7161 HUMAN OTC DRUG Claritin-D 24 Hour Loratadine and pseudoephedrine sulfate TABLET, EXTENDED RELEASE ORAL 20091201 NDA NDA020470 MSD Consumer Care, Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 11523-7162_da383402-da73-419d-b68d-930b1f2b50bf 11523-7162 HUMAN OTC DRUG Claritin-D 12 Hour Loratadine and pseudoephedrine sulfate TABLET, EXTENDED RELEASE ORAL 20091201 NDA NDA019670 MSD Consumer Care, Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 11523-7170_207f66fa-bbed-492e-8f35-67d4a2ed4498 11523-7170 HUMAN OTC DRUG Coppertone Tanning Dry Oil SPF 15 Avobenzone, Homosalate, Octisalate, and Oxybenzone SPRAY TOPICAL 19990521 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 16.89; 84.47; 42.23; 25.34 mg/mL; mg/mL; mg/mL; mg/mL 11523-7183_a912a0dc-c132-49c5-87cc-0088bffa1da5 11523-7183 HUMAN OTC DRUG Coppertone SPORT SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.76; 85.88; 42.94; 17.17; 34.35 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7184_0d1930ca-9182-4db5-ba24-0c7f147a4401 11523-7184 HUMAN OTC DRUG Coppertone UltraGuard SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.76; 85.87; 42.94; 17.17; 34.35 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7189_bd22c016-5ae9-48ce-8ad8-ecac9681cb7e 11523-7189 HUMAN OTC DRUG Bain de Soleil Orange Gelee SPF 4 Octinoxate GEL TOPICAL 19990521 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. OCTINOXATE 25 mg/g 11523-7190_d6b85c74-707f-404d-b640-080b009b0852 11523-7190 HUMAN OTC DRUG Coppertone KIDS SPF 30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30.24; 100.8; 50.4; 100.8 mg/mL; mg/mL; mg/mL; mg/mL 11523-7197_a5569cfc-cdc2-4673-bd93-349e21a36463 11523-7197 HUMAN OTC DRUG Claritin loratadine SOLUTION ORAL 20110301 NDA NDA020641 MSD Consumer Care, Inc. LORATADINE 5 mg/5mL 11523-7198_aff627cb-7393-4572-ac0d-9901c564a9fe 11523-7198 HUMAN OTC DRUG Claritin Loratadine TABLET, CHEWABLE ORAL 20090305 NDA NDA021891 MSD Consumer Care, Inc. LORATADINE 5 mg/1 11523-7200_6b7d9b71-b6fd-4d39-b46a-8a3cfacd657e 11523-7200 HUMAN OTC DRUG Claritin Liqui-Gels Loratadine CAPSULE, LIQUID FILLED ORAL 20080616 NDA NDA021952 MSD Consumer Care, Inc. LORATADINE 10 mg/1 11523-7202_9128667b-2cf3-48d6-b6bb-a47c02526fdc 11523-7202 HUMAN OTC DRUG Claritin Reditabs Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20061212 NDA NDA021993 MSD Consumer Care, Inc. LORATADINE 5 mg/1 11523-7204_2ec66bf8-23a6-4784-b709-965949c9d39d 11523-7204 HUMAN OTC DRUG A and D First Aid Lanolin and petrolatum OINTMENT TOPICAL 20030604 OTC MONOGRAPH FINAL part347 MSD Consumer Care, Inc. LANOLIN; PETROLATUM 136.4; 469.9 mg/g; mg/g 11523-7206_0e6e40d0-0d88-483c-a1e8-cfe0a5c556e1 11523-7206 HUMAN OTC DRUG Coppertone ultraGUARD SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 72.1; 41.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7207_16700cb9-001f-44c1-9977-bb0603c6ab30 11523-7207 HUMAN OTC DRUG Coppertone Water Babies SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19930512 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 72.1; 41.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7214_e26c2dbf-f3e6-48c6-9770-d2b33bd27257 11523-7214 HUMAN OTC DRUG Dr. Scholls Ingrown Toenail Pain Reliever Sodium Sulfide GEL TOPICAL 20030507 OTC MONOGRAPH FINAL part358D MSD Consumer Care, Inc. SODIUM SULFIDE 10 mg/g 11523-7216_3ef5055f-e7d6-48ff-a79b-34ae7a6960e6 11523-7216 HUMAN OTC DRUG Coppertone Tanning Dry Oil SPF 10 Homosalate, Octinoxate, Octisalate, and Oxybenzone SPRAY TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 42.2; 63.3; 42.2; 25.32 mg/mL; mg/mL; mg/mL; mg/mL 11523-7217_714b325d-838e-4114-92a1-61b22663da28 11523-7217 HUMAN OTC DRUG Coppertone KIDS SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 19990521 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.03; 86.76; 43.38; 34.7; 43.38 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7218_26f3205d-4445-4296-84b3-e3a0134f77c0 11523-7218 HUMAN OTC DRUG Coppertone UltraGuard SPF 15 Avobenzone, Homosalate, Octisalate, and Oxybenzone AEROSOL, SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 16.89; 84.47; 42.235; 25.34 mg/mL; mg/mL; mg/mL; mg/mL 11523-7219_3b44b095-3225-43d1-874e-010350beeb1f 11523-7219 HUMAN OTC DRUG Coppertone Sport AccuSpray SPF 15 Avobenzone, Homosalate, Octisalate, and Oxybenzone SPRAY TOPICAL 20140131 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 16.91; 84.55; 42.27; 25.36 mg/mL; mg/mL; mg/mL; mg/mL 11523-7221_fa9ac597-224c-46bd-a949-3fec950285c5 11523-7221 HUMAN OTC DRUG Coppertone Sport High Performance SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.3; 131.3; 50.5; 50.5; 60.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7226_645fc850-3c41-4707-a77d-00b9eb86b0a3 11523-7226 HUMAN OTC DRUG Dr. Scholls Clear Away Wart Remover One Step Salicylic Acid PLASTER TOPICAL 19900814 OTC MONOGRAPH FINAL part358B MSD Consumer Care, Inc. SALICYLIC ACID 4 mg/1 11523-7227_6d5d92dc-7968-4cc1-918b-5c891e74bcde 11523-7227 HUMAN OTC DRUG Dr. Scholls Clear Away Wart Remover Salicylic Acid SOLUTION TOPICAL 19900814 OTC MONOGRAPH FINAL part358B MSD Consumer Care, Inc. SALICYLIC ACID 150 mg/mL 11523-7228_9e14934b-83ef-4ab1-91a5-f0055ca737ca 11523-7228 HUMAN OTC DRUG Coppertone Sport SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.03; 86.76; 43.38; 34.7; 43.38 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7231_5dee7fc4-56c7-42a4-9d11-02cd5ecb6271 11523-7231 HUMAN OTC DRUG Coppertone waterBABIES Sunscreen SPF 50 avobenzone, homosalate, octisalate, octocrylene, and oxybenzone AEROSOL TOPICAL 19930512 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 130; 50; 20; 40 mg/g; mg/g; mg/g; mg/g; mg/g 11523-7234_025c2b9f-bd54-4613-8cb5-82a612d6c1a1 11523-7234 HUMAN OTC DRUG MiraLAX Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20090223 NDA NDA022015 MSD Consumer Care, Inc. POLYETHYLENE GLYCOL 3350 17 g/17g 11523-7237_a6e7c60c-1fdd-4f06-b983-009494339a14 11523-7237 HUMAN OTC DRUG Claritin Loratadine TABLET ORAL 19930412 NDA NDA019658 MSD Consumer Care, Inc. LORATADINE 10 mg/1 11523-7243_a59fdf5f-ea78-4227-9ab3-96e369f34457 11523-7243 HUMAN OTC DRUG Coppertone UltraGuard SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.03; 86.76; 43.38; 34.7; 43.38 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7250_25e0c40b-428a-4ee1-b353-803bf13b7340 11523-7250 HUMAN OTC DRUG Coppertone Tanning Dry Oil SPF 4 Homosalate and Oxybenzone SPRAY TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. HOMOSALATE; OXYBENZONE 82.22; 16.44 mg/mL; mg/mL 11523-7258_833be252-d9c1-451b-98d6-be976b9b83df 11523-7258 HUMAN OTC DRUG Coppertone Sport High Performance Faces SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.3; 131.3; 50.5; 50.5; 60.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7265_213893a2-fcae-4f16-bea2-ea076c7b707f 11523-7265 HUMAN OTC DRUG Zegerid OTC Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20100401 NDA NDA022281 MSD Consumer Care, Inc. OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 11523-7268_025c2b9f-bd54-4613-8cb5-82a612d6c1a1 11523-7268 HUMAN OTC DRUG MiraLAX Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20090223 NDA NDA022015 MSD Consumer Care, Inc. POLYETHYLENE GLYCOL 3350 17 g/17g 11523-7272_fcaf2813-5e24-4548-b621-2b7f4d630df9 11523-7272 HUMAN OTC DRUG Coppertone UltraGuard SPF 70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 19990521 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.86; 134.3; 44.77; 89.53; 53.72 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7273_1bf090e5-1176-4dcb-83f7-2ff8ad5036a5 11523-7273 HUMAN OTC DRUG Coppertone Sport AccuSpray SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20140131 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.91; 134.56; 44.85; 89.71; 53.82 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7277_c2ed2ea0-9cf0-417c-a85e-b7d4bacc7e5b 11523-7277 HUMAN OTC DRUG Coppertone UltraGuard SPF 70 Plus Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.63; 153.15; 51.05; 102.1; 61.26 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7281_95ca7114-0123-4e5c-b32a-2b8af35140e0 11523-7281 HUMAN OTC DRUG Coppertone Kids SPF 70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 103; 61.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7283_e39b8d7f-8edf-4573-8217-b4345253e83a 11523-7283 HUMAN OTC DRUG Coppertone Sport SPF 80 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 103; 61.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7288_69c933ca-d96f-417b-845b-15630232e31d 11523-7288 HUMAN OTC DRUG Coppertone SPF 4 Octinoxate and Octocrylene LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. OCTINOXATE; OCTOCRYLENE 28.95; 19.3 mg/mL; mg/mL 11523-7289_a1e89ac9-af2c-41f1-9bb8-6892ce99934f 11523-7289 HUMAN OTC DRUG Coppertone Water Babies Sunscreen SPF 70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19930512 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.63; 153.15; 51.05; 102.1; 61.26 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7290_2413d99a-e517-44e8-b397-6578c5bd06f4 11523-7290 HUMAN OTC DRUG Coppertone waterBABIES Pure and Simple SPF 50 octinoxate, octisalate, and zinc oxide LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 85.2; 56.8; 164.72 mg/mL; mg/mL; mg/mL 11523-7291_11ad1911-e451-4094-9b3a-de933b682dd7 11523-7291 HUMAN OTC DRUG Coppertone SPF 15 avobenzone, homosalate, octisalate, and octocrylene LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20.06; 100.3; 50.15; 50.15 mg/mL; mg/mL; mg/mL; mg/mL 11523-7300_1bdafeb0-2960-4407-9bb3-5542c12e8304 11523-7300 HUMAN OTC DRUG Coppertone Sensitive Skin SPF 50 Octinoxate, Octisalate, and Zinc Oxide LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 85.2; 56.8; 164.72 mg/mL; mg/mL; mg/mL 11523-7301_06ad67ef-3b24-4ab1-b366-50bfca994efe 11523-7301 HUMAN OTC DRUG Coppertone Kids SPF 50 Octinoxate, Octisalate, and Zinc Oxide LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 85.2; 56.8; 164.72 mg/mL; mg/mL; mg/mL 11523-7302_3a503b9f-b520-4e0c-9b79-21aa5d7659d3 11523-7302 HUMAN OTC DRUG Coppertone KIDS SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.03; 86.76; 43.38; 34.7; 43.38 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7303_d87117b0-dd58-4bb0-9cc9-882eb804c993 11523-7303 HUMAN OTC DRUG Coppertone Sensitive Skin SPF 50 Octinoxate, octisalate, and zinc oxide LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 85.2; 56.8; 164.72 mg/mL; mg/mL; mg/mL 11523-7306_5a4d43db-d79d-41bc-b8e8-6f20455cbcc5 11523-7306 HUMAN OTC DRUG Coppertone KIDS SPF 55 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone STICK TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 11523-7309_bf8bc25e-abe4-45c3-a829-577de79de74a 11523-7309 HUMAN OTC DRUG Coppertone Sport SPF 55 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone STICK TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 11523-7310_cffd74be-5136-4a98-bfd6-5260717fb24d 11523-7310 HUMAN OTC DRUG Coppertone Water BABIES SPF 55 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone STICK TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 11523-7312_d067979e-fe32-4b53-9a73-4276031e0085 11523-7312 HUMAN OTC DRUG Coppertone Sport Continuous SPF 100 Plus Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20140131 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27.49; 137.47; 18.33; 45.82; 91.65; 54.99 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7313_950f8592-f7c0-444a-864a-716c9c977026 11523-7313 HUMAN OTC DRUG Coppertone ultraGUARD Sunscreen SPF 100 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.06; 150.3; 50.1; 100.2; 60.12 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7316_3a5892c9-b894-454f-b3f3-d6a7bc7b038d 11523-7316 HUMAN OTC DRUG Coppertone Kids Sunscreen SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.91; 134.57; 44.86; 89.71; 53.83 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7324_c784357b-e11b-4650-9fce-16e0083cc669 11523-7324 HUMAN OTC DRUG Coppertone Water Babies Foaming Sunscreen SPF 75 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990512 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 11523-7325_b7709b14-8b43-4ac1-b6ce-9dce39474318 11523-7325 HUMAN OTC DRUG Coppertone Sport SPF 100 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.54; 152.7; 50.9; 101.8; 61.08 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7329_349fa9a2-a2be-45bb-9579-7d938fd8af53 11523-7329 HUMAN OTC DRUG Coppertone oil free Foaming Sunscreen SPF 75 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990512 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 11523-7334_965917ad-b868-4aa3-825c-c6fb949dedba 11523-7334 HUMAN OTC DRUG Coppertone SPF 8 Octinoxate and Octocrylene LOTION TOPICAL 19990621 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. OCTINOXATE; OCTOCRYLENE 70.175; 30.075 mg/mL; mg/mL 11523-7335_29999b62-5d59-4304-b1eb-a38530cf83c3 11523-7335 HUMAN OTC DRUG Coppertone SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20.06; 100.3; 50.15; 50.15 mg/mL; mg/mL; mg/mL; mg/mL 11523-7336_4eb769aa-66b6-4775-ad28-f0cb9455c79a 11523-7336 HUMAN OTC DRUG Coppertone SPORT PRO SERIES SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene SPRAY TOPICAL 20111123 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 25.44; 84.81; 38.16; 33.92 mg/mL; mg/mL; mg/mL; mg/mL 11523-7337_e33f5fed-887c-42b8-841a-8530a2c68fa1 11523-7337 HUMAN OTC DRUG Coppertone SPORT PRO SERIES SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20111123 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.89; 86.31; 38.84; 34.52; 34.52 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7338_1c928efd-6d72-4c72-a3b7-ee74e675ed8f 11523-7338 HUMAN OTC DRUG Coppertone SPORT PRO SERIES SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20111123 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.99; 116.97; 40.49; 80.98; 53.99 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7340_394a77de-88b0-4594-89ee-ca181f761135 11523-7340 HUMAN OTC DRUG Coppertone Dry SPF 10 Homosalate, Octinoxate, Octisalate, and Oxybenzone OIL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 42.2; 63.3; 42.2; 25.32 mg/mL; mg/mL; mg/mL; mg/mL 11523-7341_025c2b9f-bd54-4613-8cb5-82a612d6c1a1 11523-7341 HUMAN OTC DRUG MiraLAX Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20090223 NDA NDA022015 MSD Consumer Care, Inc. POLYETHYLENE GLYCOL 3350 17 g/17g 11523-7342_122121e3-ab15-4fe1-9fc4-7d57bc42b8b2 11523-7342 HUMAN OTC DRUG Coppertone Wet n Clear SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.75; 89.18; 40.13; 80.26; 44.59 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7343_54a1d750-8134-4815-bbf7-389d5631ffd9 11523-7343 HUMAN OTC DRUG Coppertone Wet n Clear SPF 45plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.48; 88.25; 39.71; 79.43; 44.13 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7344_9738082a-116c-46ec-bc9a-3387fa3dffa8 11523-7344 HUMAN OTC DRUG Coppertone Wet n Clear Kids SPF 45plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.48; 88.25; 39.71; 79.43; 44.13 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7345_ba3dd790-4345-4fbc-8fc8-5380fa62755d 11523-7345 HUMAN OTC DRUG Coppertone TattooGuard Sunscreen SPF 50 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone STICK TOPICAL 20121114 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 11523-7346_dbf13ec2-89a2-4304-b0db-b51f5adfda96 11523-7346 HUMAN OTC DRUG Coppertone Tattoo Guard SPF 50 Octinoxate, Octisalate, and Zinc Oxide LOTION TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 85.2; 56.8; 164.72 mg/mL; mg/mL; mg/mL 11523-7347_476b3092-1d74-47d7-8752-c51a0d8c6238 11523-7347 HUMAN OTC DRUG Coppertone Tanning Sunscreen SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene AEROSOL, FOAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 100; 40.5; 50 mg/g; mg/g; mg/g; mg/g 11523-7349_a376b468-0617-4564-a77e-0e1caaf22f2a 11523-7349 HUMAN OTC DRUG Coppertone oil free faces SPF 15 avobenzone, homosalate, octisalate, and octocrylene LOTION TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20.06; 100.3; 50.15; 50.15 mg/mL; mg/mL; mg/mL; mg/mL 11523-7350_d5bc2ff1-efdc-49ac-b575-580f35922942 11523-7350 HUMAN OTC DRUG Coppertone Oil Free Faces SPF 50 Plus avobenzone, homosalate, octisalate, octocrylene, and oxybenzone LOTION TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.63; 153.15; 51.05; 102.1; 61.26 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7351_5cdf87fc-1714-4a30-80fe-578da39050cc 11523-7351 HUMAN OTC DRUG Coppertone kids SPF 75 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 11523-7354_ae25032f-46e8-485a-8100-3826a2978565 11523-7354 HUMAN OTC DRUG Coppertone Wet and Clear SPF 50 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.73; 89.11; 40.1; 80.2; 44.56 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7355_c70bf116-aa8d-4330-90d5-b974df6d75ee 11523-7355 HUMAN OTC DRUG Coppertone Wet and Clear Kids SPF 50 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.73; 89.11; 40.1; 80.2; 44.56 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7356_9e8a0c83-d7cd-4848-941e-21eaf4747f8a 11523-7356 HUMAN OTC DRUG Dr. Scholls Work Corn Removers Salicylic Acid DISC TOPICAL 19900814 OTC MONOGRAPH FINAL part358F MSD Consumer Care, Inc. SALICYLIC ACID 4 mg/1 11523-7357_e663d1d0-041c-455e-9201-5886b3402222 11523-7357 HUMAN OTC DRUG Coppertone KIDS SPF 50 Avobenzone, Homosalate, Octisalate, and Oxybenzone AEROSOL, SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 26; 130.02; 43.34; 52.01 mg/mL; mg/mL; mg/mL; mg/mL 11523-7358_77cc7153-9a51-4f9e-a3c4-631f7deb194f 11523-7358 HUMAN OTC DRUG Coppertone Tattoo Guard Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.03; 86.76; 43.38; 34.7; 43.38 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7359_fd272e66-7818-4434-8fae-2d31386d4ee3 11523-7359 HUMAN OTC DRUG Coppertone Clearly Sheer For Sunny Days SPF 30 avobenzone, octocrylene, and oxybenzone SPRAY TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 20; 90; 30 mg/g; mg/g; mg/g 11523-7360_95ec906b-a8d6-470b-8781-bc5169c1c576 11523-7360 HUMAN OTC DRUG Coppertone Clearly Sheer For Beach and Pool SPF 30 Avobenzone, octocrylene, and oxybenzone SPRAY TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 20; 90; 30 mg/g; mg/g; mg/g 11523-7361_da8fdcc5-d44c-4c1b-aabe-6ce09fcded24 11523-7361 HUMAN OTC DRUG Coppertone Clearly Sheer For Beach and Pool SPF 50 Plus Avobenzone, homosalate, octisalate, octocrylene, and oxybenzone SPRAY TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 45; 90; 20 mg/g; mg/g; mg/g; mg/g; mg/g 11523-7362_18338a98-c6ee-4a75-b415-f6cbb91738ee 11523-7362 HUMAN OTC DRUG Coppertone kids SPF 70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, FOAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 11523-7363_074710fa-4d1d-43fd-93f8-875e855f9b97 11523-7363 HUMAN OTC DRUG Coppertone water BABIES SPF 70 plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, FOAM TOPICAL 20140201 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 31.2; 156; 52; 104; 62.4 mg/g; mg/g; mg/g; mg/g; mg/g 11523-7364_e74d1795-8582-4e9f-ae7e-ce414d33b862 11523-7364 HUMAN OTC DRUG Coppertone Sport SPF 75 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20140301 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 103; 61.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7365_8d76052b-1973-4aa3-8ab2-0c9a31e599f3 11523-7365 HUMAN OTC DRUG Coppertone Clearly Sheer For Sunny Days SPF 15 Avobenzone, homosalate, octisalate, and octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30.51; 30.51; 46.27; 50.85 mg/mL; mg/mL; mg/mL; mg/mL 11523-7366_121c782e-f647-45c5-b613-91ad1b44825f 11523-7366 HUMAN OTC DRUG Coppertone Clearly Sheer For Sunny Days SPF 30 Avobenzone, homosalate, octisalate, and octocrylene LOTION TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30.75; 102.5; 46.64; 82 mg/mL; mg/mL; mg/mL; mg/mL 11523-7367_48f5b116-e59b-49b0-b0c4-c6c80e370c0e 11523-7367 HUMAN OTC DRUG Coppertone Clearly Sheer For Sunny Days SPF 30 Face Avobenzone, homosalate, octisalate, and octocrylene LOTION TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30.7; 102.5; 46.6; 82 mg/mL; mg/mL; mg/mL; mg/mL 11523-7368_17c7df5f-c131-4354-8678-8dddbbbd7cb9 11523-7368 HUMAN OTC DRUG Coppertone Clearly Sheer For Beach and Pool SPF 50 Plus Avobenzone, homosalate, octisalate, octocrylene, and oxybenzone LOTION TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 31.02; 103.4; 47.05; 93.06; 51.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7369_196e440d-9539-42ee-b60a-46b64e4a50a6 11523-7369 HUMAN OTC DRUG Coppertone Clearly Sheer For Beach and Pool SPF 50 Plus Face Avobenzone, homosalate, octisalate, octocrylene, and oxybenzone LOTION TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 31.02; 103.4; 47.05; 93.06; 51.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7370_015f5830-b792-4350-a745-68c0458045f0 11523-7370 HUMAN OTC DRUG Coppertone wet n clear SPF 30 Avobenzone, Homosalate, Octisalate, octocrylene, and Oxybenzone SPRAY TOPICAL 20130331 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.32; 87.74; 39.48; 43.87; 35.09 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7371_071706bb-a825-45a6-aa1c-a3115bfc5214 11523-7371 HUMAN OTC DRUG Coppertone kids SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.3; 131.3; 50.5; 50.5; 60.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7372_38a85fca-4cc9-472d-babd-7a92f0b5cb9f 11523-7372 HUMAN OTC DRUG Coppertone Sport High Performance SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.3; 118.1; 45.4; 45.4; 54.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7373_92b2727a-4e5d-4bb3-9607-7fc9ef3d48c4 11523-7373 HUMAN OTC DRUG Coppertone Sport AccuSpray SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20140117 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.76; 85.88; 42.94; 17.17; 34.35 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 11523-7374_f2214975-fdfa-44d0-ba16-03be40259aaa 11523-7374 HUMAN OTC DRUG Bain de Soleil Transpare SPF 10 Homosalate, Octinoxate, Octisalate, and Oxybenzone SPRAY TOPICAL 19990521 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 42.2; 63.3; 42.2; 25.32 mg/mL; mg/mL; mg/mL; mg/mL 11523-7375_7814f3f0-3e69-444a-981c-c8b507559fac 11523-7375 HUMAN OTC DRUG Bain de Soleil Transpare SPF 4 Homosalate and Oxybenzone SPRAY TOPICAL 19990521 OTC MONOGRAPH FINAL part352 MSD Consumer Care, Inc. HOMOSALATE; OXYBENZONE 82.22; 16.44 mg/mL; mg/mL 11527-016_74ed9f77-794b-4d84-b0d6-4d0bf3b809ee 11527-016 HUMAN OTC DRUG Dr. Sheffield Fluoride Anticavity Fluoride Anticavity Toothpaste PASTE, DENTIFRICE ORAL 20060102 OTC MONOGRAPH FINAL part355 Faria LLC dba Sheffield Pharmaceutcials SODIUM FLUORIDE 2.43 mg/g 11527-051_ed1c4da6-6445-4a82-8121-722c2eda06ed 11527-051 HUMAN OTC DRUG Tolnaftate TOLNAFTATE CREAM TOPICAL 20091007 OTC MONOGRAPH FINAL part333C Faria Limited dba Sheffield Pharmaceuticals TOLNAFTATE 10 mg/g 11527-052_78f14cb3-e7ae-4566-97e3-b20d030f7ffb 11527-052 HUMAN OTC DRUG Dr. Sheffield Hydrocortisone Anti itch Hydrocortisone CREAM TOPICAL 20070710 OTC MONOGRAPH NOT FINAL part348 Faria LLC dba Sheffield Pharmaceuticals HYDROCORTISONE 10 mg/g 11527-057_ccbdb264-e98c-49ff-89e7-392fc2a21381 11527-057 HUMAN OTC DRUG Dr Sheffield Muscle Rub Cream Muscle Rub Cream CREAM TOPICAL 20020424 OTC MONOGRAPH NOT FINAL part348 Faria LLC dba Sheffield Pharmaceuticals MENTHOL; METHYL SALICYLATE 100; 150 mg/g; mg/g 11527-061_b85ffec6-af96-4d35-b529-779cb2906135 11527-061 HUMAN OTC DRUG Sheffield Baby Teething Gel BENZOCAINE GEL ORAL 20030617 OTC MONOGRAPH NOT FINAL part356 Faria LLC dba Sheffield Pharmaceuticals BENZOCAINE 75 mg/g 11527-062_597b7ed5-3464-481a-ad76-7db05e91f5f5 11527-062 HUMAN OTC DRUG Sheffield Pain Relief BENZOCAINE GEL ORAL 20060130 OTC MONOGRAPH NOT FINAL part356 Faria LLC dba Sheffield Pharmaceuticals BENZOCAINE 200 mg/g 11527-069_630434a1-c9d6-4336-bca4-e1e9631da8ed 11527-069 HUMAN OTC DRUG Dr. Sheffield Anti Itch Cream Anti Itch Cream CREAM TOPICAL 20081111 OTC MONOGRAPH FINAL part347 Faria LLC dba Sheffield Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g 11527-071_26002c54-7013-4187-80e3-65907591d9c4 11527-071 HUMAN OTC DRUG Dr Sheffield Athletes Foot CLOTRIMAZOLE CREAM TOPICAL 20041004 OTC MONOGRAPH FINAL part333C Faria Limited dba Sheffield Pharmaceuticals CLOTRIMAZOLE 10 mg/g 11527-089_65d48985-9a9f-47cd-8817-7143581ff38d 11527-089 HUMAN OTC DRUG Sheffield Arthritis and Muscle Pain Relief CAPSICUM OLEORESIN CREAM TOPICAL 20100414 OTC MONOGRAPH NOT FINAL part348 Faria LLC dba Sheffield Pharmaceuticals CAPSICUM OLEORESIN .25 mg/g 11527-140_1deba1aa-2d0d-4fa4-b070-a208230007c2 11527-140 HUMAN OTC DRUG 12 Hour Original Nasal Decongestant Nasal Spray LIQUID NASAL 20140530 OTC MONOGRAPH FINAL part341 Faria LLC dba Sheffield Pharmaceutical OXYMETAZOLINE HYDROCHLORIDE 50 mg/100mL 11527-161_517e9e9e-e549-4850-a4af-7f5d2d0aebb6 11527-161 HUMAN OTC DRUG Sheffield Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate, Pramoxine Hydrochloride OINTMENT TOPICAL 20110123 OTC MONOGRAPH FINAL part333B Faria LLC dba Sheffield Pharmaceuticals BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 11527-162_7d91a3ae-8ede-4476-a349-4e8edae2fa67 11527-162 HUMAN OTC DRUG Sheffield Triple Antibiotic Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate OINTMENT TOPICAL 20110123 OTC MONOGRAPH FINAL part333B Faria LLC dba Sheffield Pharmaceuticals BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 11527-163_b186de04-6829-411d-9629-e3703f21c15b 11527-163 HUMAN OTC DRUG Sheffield Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20120925 OTC MONOGRAPH FINAL part333B Faria LLC dba Sheffield Pharmaceuticals BACITRACIN ZINC 500 [USP'U]/g 11527-478_73e02081-ac53-41b5-b085-9428459deb1e 11527-478 HUMAN OTC DRUG Dr. Sheffield Psoriasis Medicated Moisturizer Psoriasis Medicated Moisturizer LOTION TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Faria LLC dba Sheffield Pharmaceuticals SALICYLIC ACID 20 mg/g 11528-010_9f40fca2-0c26-4358-b28a-e2f78eacbed7 11528-010 HUMAN PRESCRIPTION DRUG COVARYX ESTROGENS, ESTERIFIED and METHYLTESTOSTERONE TABLET, COATED ORAL 20070401 UNAPPROVED DRUG OTHER CENTRIX PHARMACEUTICAL, INC, ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE 1.25; 2.5 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 11528-020_9f40fca2-0c26-4358-b28a-e2f78eacbed7 11528-020 HUMAN PRESCRIPTION DRUG COVARYX HS ESTROGENS, ESTERIFIED and METHYLTESTOSTERONE TABLET, COATED ORAL 20070401 UNAPPROVED DRUG OTHER CENTRIX PHARMACEUTICAL, INC, ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE .625; 1.25 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 11528-095_79167d2d-a1c3-41ce-8d38-85203c7ba593 11528-095 HUMAN PRESCRIPTION DRUG Paire OB Plus DHA Paire OB Plus DHA KIT 20101013 UNAPPROVED DRUG OTHER Centrix Pharmaceutical, Inc. 11528-107_0efa1551-091d-4a7d-95ee-f24fd2277ebd 11528-107 HUMAN OTC DRUG Dicel CD Brompheniramine Maleate, Chlophendianol Hydrochloride, Pseudoephedrine Hydrochloride LIQUID ORAL 20100506 OTC MONOGRAPH FINAL part341 Centrix Pharmaceutical BROMPHENIRAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 12.5; 30 mg/5mL; mg/5mL; mg/5mL 11528-135_ba250b4e-084e-4319-ba77-becbff8a204f 11528-135 HUMAN PRESCRIPTION DRUG MAXARON FORTE IRON, ASCORBIC ACID, METHYLCOBALAMIN, and LEVOMEFOLATE CALCIUM CAPSULE ORAL 20071201 UNAPPROVED DRUG OTHER CENTRIX PHARMACEUTICAL, INC, ASCORBIC ACID; IRON; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN 200; 150; 1.13; 250 mg/1; mg/1; mg/1; ug/1 11528-140_9e7dbf91-470b-44d0-beac-5bf3e8410c80 11528-140 HUMAN OTC DRUG Clofera Chlophedianol Hydrochloride and Pseudoephedrine Hydrochloride LIQUID ORAL 20090814 OTC MONOGRAPH FINAL part341 Centrix Pharmaceutical, Inc. CHLOPHEDIANOL HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 12.5; 30 mg/5mL; mg/5mL 11534-013_6be65bdd-e94a-4682-9977-043741174c59 11534-013 HUMAN OTC DRUG Bisacodyl Bisacodyl TABLET, DELAYED RELEASE ORAL 20050708 OTC MONOGRAPH NOT FINAL part334 Sunrise Pharmaceutical Inc BISACODYL 5 mg/1 11534-073_4a9520e4-2015-4055-a4e2-ec077a8b5f30 11534-073 HUMAN OTC DRUG Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20051226 OTC MONOGRAPH FINAL part343 Sunrise Pharmaceutical Inc ASPIRIN 81 mg/1 11534-090_dda29277-e3fb-4563-a038-53838c055ff4 11534-090 HUMAN OTC DRUG Senna and Docusate Sodium Senna and Docusate Sodium TABLET, FILM COATED ORAL 20070726 OTC MONOGRAPH NOT FINAL part334 Sunrise Pharmaceutical Inc DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 11534-134_d08a4708-1de9-4bf4-8444-80d8942995b8 11534-134 HUMAN OTC DRUG Senna and Docusate Sodium Senna and Docusate Sodium TABLET, FILM COATED ORAL 20070726 OTC MONOGRAPH NOT FINAL part334 Sunrise Pharmaceutical Inc DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 11534-155_5fdaba26-4c64-4896-a89a-69fefec6e563 11534-155 HUMAN OTC DRUG Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20100103 OTC MONOGRAPH FINAL part343 Sunrise Pharmaceutical Inc ASPIRIN 81 mg/1 11534-156_8f6065f1-bb7c-4422-8f81-e6da2e56b22d 11534-156 HUMAN OTC DRUG Bisacodyl Bisacodyl TABLET, DELAYED RELEASE ORAL 20050708 OTC MONOGRAPH NOT FINAL part334 Sunrise Pharmaceutical Inc BISACODYL 5 mg/1 11534-164_252a4044-8b7f-4d7f-b501-3d089ca4bb5a 11534-164 HUMAN OTC DRUG Guiafenesin Guiafenesin TABLET ORAL 20050708 OTC MONOGRAPH FINAL part341 Sunrise Pharmaceutical Inc GUAIFENESIN 400 mg/1 11535-112_abe9941b-aba7-4a19-82fb-bab64cff9ef7 11535-112 HUMAN OTC DRUG Fuller Antibacterial Hand TRICLOSAN LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E The Fuller Brush Company TRICLOSAN 5 mg/mL 11559-001_64b58032-ce2b-4254-a9fa-8ce90d6d139a 11559-001 HUMAN OTC DRUG YOUTH DEW ROLL-ON ANTIPERSPIRANT DEODORANT ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 19770401 OTC MONOGRAPH FINAL part350 ESTEE LAUDER INC ALUMINUM CHLOROHYDRATE 20 mL/100mL 11559-002_d191c825-628a-4a1f-80ef-8b85fb23166e 11559-002 HUMAN OTC DRUG MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY SPF 15 TITANIUM DIOXIDE CREAM TOPICAL 19990101 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC TITANIUM DIOXIDE 19.9 mL/100mL 11559-003_64f94403-12d6-475a-8c97-fe164f4e2da9 11559-003 HUMAN OTC DRUG FUTURIST AGE RESISTING MAKEUP SPF 15 TITANIUM DIOXIDE LIQUID TOPICAL 19960901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE 2.2 mL/100mL 11559-004_6be0a7e4-4ea4-4d4c-b518-bad45782b6fb 11559-004 HUMAN OTC DRUG CYBERWHITE EX EXTRA INTENSIVE BB CREME MULTI ACTION FORMULA SPF35 OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 4; 2.5; 1.1; 3.5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 11559-006_143b26b6-7a07-41c3-9265-60128a9fdd20 11559-006 HUMAN OTC DRUG CYBER WHITE BRILLIANT CELLS FULL SPECTRUM BRIGHTENING UV PROTECTOR SPF 50 HOMOSALATE, OCTISALATE, AVOBENZONE, OXYBENZONE LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 5; 5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL 11559-007_05b1a435-8ea7-47b9-8c86-aa9d3f749584 11559-007 HUMAN OTC DRUG DAYWEAR ADVANCED MULTI-PROTECTION ANTIOXIDANT CREME SPF 15 FOR DRY SKIN OCTISALATE, AVOBENZONE, HOMOSALATE CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; HOMOSALATE; OCTISALATE 3; 2; 5 mL/100mL; mL/100mL; mL/100mL 11559-008_7ad13077-5665-4406-9884-3aa20f3f2a86 11559-008 HUMAN OTC DRUG DAYWEAR SHEER TINT RELEASE ADVANCED MULTI-PROTECTION ANTI-OXIDANT MOISTURIZER SPF 15 OCTISALATE, AVOBENZONE LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTISALATE 3; 5 mL/100mL; mL/100mL 11559-009_7da066f7-4938-49cb-ba94-42268b068ae5 11559-009 HUMAN OTC DRUG DAYWEAR ADVANCED MULTIPROTECTION ANTIOXIDANT CREME SPF 15 FOR NORMAL COMBINATION SKIN OCTISALATE, AVOBENZONE CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTISALATE 3; 5 mL/100mL; mL/100mL 11559-010_fd8e22f2-cb7e-4462-8957-ab48e76403d3 11559-010 HUMAN OTC DRUG DAYWEAR ADVANCED MULTI-PROTECTION ANTIOXIDANT SPF 15 OILY SKIN OCTISALATE, AVOBENZONE, HOMOSALATE LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; HOMOSALATE; OCTISALATE 3; 2; 4.9 mL/100mL; mL/100mL; mL/100mL 11559-011_61256a00-2974-4f15-977f-47cc7aafb4f7 11559-011 HUMAN OTC DRUG RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK CREME SPF 15 NML COMBO OCTINOXATE, OCTISALATE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; OCTISALATE 7.5; 3.5 mL/100mL; mL/100mL 11559-012_fa9febfb-6fbc-43a6-b37e-f35d08984f4b 11559-012 HUMAN OTC DRUG RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK SPF15 FOR DRY SKIN OCINOXATE CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE 7.5 mL/100mL 11559-013_a5160066-95d9-4184-9452-bd120e3d66fe 11559-013 HUMAN OTC DRUG RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK SPF15 NORMAL COMBO SKIN OCTINOXATE, TITANIUM DIOXIDE LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; TITANIUM DIOXIDE 7.5; 1.4 mL/100mL; mL/100mL 11559-014_b1fe154e-ce61-4912-a867-3cb86894ff4e 11559-014 HUMAN OTC DRUG DOUBLE WEAR MINERAL RICH LOOSE POWDER MAKEUP SPF 12 TITANIUM DIOXIDE POWDER TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC TITANIUM DIOXIDE 2.2 g/100g 11559-015_07be7bfd-5feb-4481-9559-4e6d4b556212 11559-015 HUMAN OTC DRUG DAYWEAR BB ANTI OXIDANT BEAUTY BENEFIT BROAD SPECTRUM SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 4; 2.5; 1.1 mL/100mL; mL/100mL; mL/100mL; mL/100mL 11559-017_041b854b-9555-4aa2-bcca-badf10d5886f 11559-017 HUMAN OTC DRUG RE NUTRIV RADIANT UV BASE BROAD SPECTRUM SPF 50 HOMOSALATE , OCTYL SALICYLATE, AVOBENZONE, OXYBENZONE, OCTOCRYLENE LOTION TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 5; 5; 2.7; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL; nmol/100mL 11559-018_a37db316-79dd-47d1-a05a-e86643cc9fe7 11559-018 HUMAN OTC DRUG RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 AVOBENZONE, OCTISALATE, and OCTOCRYLENE CREAM TOPICAL 20101012 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTISALATE; OCTOCRYLENE .0312; .052; .02808 g/mL; g/mL; g/mL 11559-020_525face8-dc5d-4ba4-a682-1beb6322ed5a 11559-020 HUMAN OTC DRUG ADVANCED TIME ZONE AGE REVERSING LINE WRINKLE BROAD SPECTRUM SPF 15 DRY SKIN AVOBENZONE, OCTISALATE, and OCTOCRYLENE CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 2.7 mL/100mL; mL/100mL; mL/100mL 11559-021_2c8d36a1-5545-4ce8-b066-eb011dba96d0 11559-021 HUMAN OTC DRUG ADVANCED TIME ZONE AGE REVERSING LINE WRINKLE BROAD SPECTRUM SPF 15 NORMAL COMBO SKIN AVOBENZONE, OCTINOXATE, and OCTISALATE CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 mL/100mL; mL/100mL; mL/100mL 11559-023_b57817b0-4258-4e1e-8ae8-4d57a2e1e59c 11559-023 HUMAN OTC DRUG DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT OIL-FREE BROAD SPECTRUM SPF 25 AVOBENZONE, OCTISALATE, and OCTOCRYLENE CREAM TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTISALATE; OCTOCRYLENE .0303; .0505; .02727 g/mL; g/mL; g/mL 11559-025_2dbf753b-4b6c-4d0a-96c5-fe63ff27f224 11559-025 HUMAN OTC DRUG RESILIENCE LIFT FIRMING/SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 NML/COMBO OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; TITANIUM DIOXIDE .0765; .01734 g/100mL; g/100mL 11559-026_ae5066bd-3f04-4c6e-a06a-4897f3de9910 11559-026 HUMAN OTC DRUG DAY WEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT AND UV DEFENSE BROAD SPECTRUM SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE LOTION TOPICAL 20121107 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .0312; .052; .052; .02808; .0312 g/mL; g/mL; g/mL; g/mL; g/mL 11559-029_c96cc1d5-acfd-4ed4-8e0d-584cf3d95bb1 11559-029 HUMAN OTC DRUG RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 NML COMBO AVOBENZONE, OCTISALATE, and OCTOCRYLENE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTISALATE; OCTOCRYLENE .0303; .0505; .2727 g/mL; g/mL; g/mL 11559-035_ef289056-5aba-4dec-a870-4add0d46e503 11559-035 HUMAN OTC DRUG ADVANCED TIME ZONE AGE REVERSING LINE/WRINKLE OIL FREE BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN AVOBENZONE, OCTINOXATE, and OCTISALATE CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTINOXATE; OCTISALATE .03; .075; .05 g/mL; g/mL; g/mL 11559-036_997ffe0a-d54d-47c4-a5cc-85dee36c725f 11559-036 HUMAN OTC DRUG DOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; TITANIUM DIOXIDE 4.9; 1.9 g/100g; g/100g 11559-037_92fd4bbc-9326-4d73-af81-82a37cdd3b73 11559-037 HUMAN OTC DRUG CYBERWHITE HD UV PROTECTOR BROAD SPECTRUM SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .0309; .0515; .0515; .0278; .0309 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 11559-038_33e1e5b5-c66a-49b4-942c-79f2cb9b9801 11559-038 HUMAN OTC DRUG DOUBLE WEAR ALL DAY GLOW BB MOISTURE MAKEUP BROAD SPECTRUM SPF 30 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE .085125; .05675; .05902; .03632 g/100mL; g/100mL; g/100mL; g/100mL 11559-039_487e60e5-20ff-454a-a3c4-d605c2cc54ef 11559-039 HUMAN OTC DRUG CLEAR DIFFERENCE BB COMPLEXION PERFECTING BB BROAD SPECTRUM SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .08175; .0436; .02725; .01199 g/100mL; g/100mL; g/100mL; g/100mL 11559-040_aaad7c1d-3166-4a2b-9625-6edf325c2d46 11559-040 HUMAN OTC DRUG CYBERWHITE HD BB ADVANCED BRIGHTENING BROAD SPECTRUM SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .0309; .0515; .0515; .0278; .0309 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 11559-041_74e68426-cad7-4cf4-89c7-564e5d95b94a 11559-041 HUMAN OTC DRUG CLEAR DIFFERENCE ADVANCED BLEMISH SERUM SALICYLIC ACID LOTION TOPICAL 20140401 OTC MONOGRAPH FINAL part333D ESTEE LAUDER INC SALICYLIC ACID .0053 g/100mL 11559-042_d798293b-82a2-4dd4-9aeb-dd66fae5161b 11559-042 HUMAN OTC DRUG Perfectionist Youth-Infusing Makeup Broad Spectrum SPF 25 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; TITANIUM DIOXIDE .0795; .02014 g/100mL; g/100mL 11559-043_e770a05f-3e65-4047-9e14-aad256cdc0d8 11559-043 HUMAN OTC DRUG ENLIGHTEN EE EVEN EFFECT SKIN TONE CORRECTOR SPF BROAD SPECTRUM SPF 30 HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, and TITANIUM DIOXIDE LOTION TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .0315; .0315; .02835; .0315; .01995 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 11559-044_8cee12b1-2d09-43dc-964d-92cd6c0cb5e2 11559-044 HUMAN OTC DRUG CLEAR DIFFERENCE TARGETED BLEMISH TREATMENT SALICYLIC ACID LOTION TOPICAL 20141001 OTC MONOGRAPH FINAL part333D ESTEE LAUDER INC SALICYLIC ACID .0091 g/100mL 11559-720_7d3ee599-4b0a-470b-a054-99978b5f37c8 11559-720 HUMAN OTC DRUG RESILIENCE LIFT EXTREME CREME COMPACT MAKEUP SPF 15 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; TITANIUM DIOXIDE 5; 2 g/100g; g/100g 11559-722_aa70c32e-32e4-42f5-86d8-15ed91feab81 11559-722 HUMAN OTC DRUG DOUBLE WEAR LIGHT STAY IN PLACE MAKEUP SPF 10 TITANIUM DIOXIDE LIQUID TOPICAL 20070901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC. TITANIUM DIOXIDE 5 mL/100mL 11559-724_32e26906-5a70-461c-81fd-a1b76939df66 11559-724 HUMAN OTC DRUG RE-NUTRIV ULTIMATE LIFTING MAKEUP SPF15 TITANIUM DIOXIDE CREAM TOPICAL 20050101 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC TITANIUM DIOXIDE 1.4 mL/100mL 11559-725_ead5a455-5fe0-460e-8e8e-6db71d2d49bd 11559-725 HUMAN OTC DRUG LIP CONDITIONER SPF 15 OCTINOXATE LIPSTICK TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE 3.5 g/100g 11559-727_03f45157-ff4a-41c9-9e29-c932aaeac539 11559-727 HUMAN OTC DRUG NUTRITIOUS VITA MINERAL LOOSE POWDER MAKEUP SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC TITANIUM DIOXIDE 2.1 g/100g 11559-728_ad2d5eca-9665-4aec-868a-ab0640843622 11559-728 HUMAN OTC DRUG TIME ZONE LINE AND WRINKLE REDUCING CREME SPF 15 FOR DRY SKIN OCTSALATE, AVOBENZONE CREAM TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTISALATE 3; 5 mL/100mL; mL/100mL 11559-729_d35449cf-3329-4773-980d-4230a255feae 11559-729 HUMAN OTC DRUG DOUBLE WEAR STAY IN PLACE SPF 10 MAKEUP TITANIUM DIOXIDE POWDER TOPICAL 20070301 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC TITANIUM DIOXIDE 4 g/100g 11559-732_12db5263-21be-4350-9165-8e83a41f5067 11559-732 HUMAN OTC DRUG DOUBLE MATTE OIL CONTROL MAKEUP SPF 15 OCTINOXATE LIQUID TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part352 Estee Lauder Inc. OCTINOXATE 2.2 mL/100mL 11559-736_57bb13de-f970-4ea2-aa61-d31b15527599 11559-736 HUMAN OTC DRUG EQUALIZER SMART MAKEUP SPF 10 TITANIUM DIOXIDE LOTION TOPICAL 20081226 OTC MONOGRAPH NOT FINAL part352 Estee Lauder Inc. TITANIUM DIOXIDE 2 mL/100mL 11559-737_c1f40cf7-0c05-4f20-b8a7-63056e305da7 11559-737 HUMAN OTC DRUG TIME ZONE LINE AND WRINKLE REDUCING CREME SPF 15 NORMAL COMBO SKIN OCTINOXATE, OCTSALATE, AVOBENZONE CREAM TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 mL/100mL; mL/100mL; mL/100mL 11559-739_32c86997-5bf8-416c-b960-c9ec038bef51 11559-739 HUMAN OTC DRUG NUTRITIOUS VITA-MINERAL MAKEUP SPF 10 TITANIUM DIOXIDE LIQUID TOPICAL 20081122 OTC MONOGRAPH NOT FINAL part352 Estee Lauder Inc. TITANIUM DIOXIDE 2.4 mL/100mL 11559-746_8a53c88e-f816-48da-b647-13b847afe0fe 11559-746 HUMAN OTC DRUG RENUTRIV ULTIMATE RADIANCE MAKEUP SPF 15 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; TITANIUM DIOXIDE 2.2; 1.4 mL/100mL; mL/100mL 11559-754_292e7622-c056-4857-b37e-76ff2a5a86df 11559-754 HUMAN OTC DRUG DAYWEAR PLUS MULTI PROTECTION TINTED MOISTURIZER SPF 15 OCTINOXATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20060901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTINOXATE; OCTISALATE 2; 7.5; 5 mL/100mL; mL/100mL; mL/100mL 11559-769_b15b2cb1-51f7-453d-b500-ea0a00851eec 11559-769 HUMAN OTC DRUG RE-NUTRIV INTENSIVE LIFTNG MAKE UP SPF15 TITANIUM DIOXIDE CREAM TOPICAL 19991201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC TITANIUM DIOXIDE 1.4 mL/100mL 11559-932_3a086eeb-c2ea-4c86-b64d-03da38c5dd89 11559-932 HUMAN OTC DRUG RESILIENCE LIFT EXTREME ULTRA FIRMING SPF 15 OCTINOXATE, OCTISALATE CREAM TOPICAL 20080501 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; OCTISALATE 7.5; 3.5 mL/100mL; mL/100mL 11559-945_25abe3f5-42f2-470e-945c-bc5169461477 11559-945 HUMAN OTC DRUG DOUBLE WEAR STAY IN PLACE MAKEUP SPF 10 TITANIUM DIOXIDE LIQUID TOPICAL 19961201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC. TITANIUM DIOXIDE 1 mL/100mL 11559-967_3a358da9-9164-4d82-bfb1-22404908013b 11559-967 HUMAN OTC DRUG Resilience Lift Extreme Radiant Lifting Makeup SPF 15 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20060601 OTC MONOGRAPH NOT FINAL part352 Estee Lauder Inc. OCTINOXATE; TITANIUM DIOXIDE 4.2; 1 mL/100mL; mL/100mL 11559-969_2a2f19e4-d8c1-4e3a-bcce-48877f01b078 11559-969 HUMAN OTC DRUG DOUBLE WEAR STAY IN PLACE CONCEALER SPF 10 TITANIUM DIOXIDE LIQUID TOPICAL 19981001 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC TITANIUM DIOXIDE 4.2 mL/100mL 11564-001_b3a82a5a-eb15-4b64-89c7-6173a35a2b79 11564-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS Fresno Oxygen and Welding Suppliers OXYGEN 992 mL/L 11564-002_7de8d4b1-4e25-49ff-9d2d-ac6746c8a20a 11564-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20050101 UNAPPROVED MEDICAL GAS Fresno Oxygen and Welding Suppliers NITROGEN 992 mL/L 11564-003_2bf9a5b1-2088-4728-9514-550285744230 11564-003 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20050101 UNAPPROVED MEDICAL GAS Fresno Oxygen and Welding Suppliers AIR 1000 mL/L 11584-0029_2abeb05e-a820-4ca8-8c13-9ee71c5f3be4 11584-0029 HUMAN PRESCRIPTION DRUG Tencon butalbital and acetaminophen TABLET ORAL 20011130 ANDA ANDA089988 International Ethical Labs, Inc. ACETAMINOPHEN; BUTALBITAL 650; 50 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] 11584-0030_5d5ec2cc-3ef2-4b98-8356-52dee0a73b5a 11584-0030 HUMAN PRESCRIPTION DRUG Tencon butalbital and acetaminophen TABLET ORAL 20131010 ANDA ANDA089987 International Ethical Labs, Inc. ACETAMINOPHEN; BUTALBITAL 325; 50 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] 11584-0476_d790690a-7191-4572-86f0-b39f66e86356 11584-0476 HUMAN PRESCRIPTION DRUG Relagesic Acetaminophen and Phenyltoloxamine Citrate TABLET ORAL 19950916 UNAPPROVED DRUG OTHER International Ethical Labs, inc. ACETAMINOPHEN; PHENYLTOLOXAMINE CITRATE 650; 50 mg/1; mg/1 11584-1032_2e6a4425-38e6-4fb4-950c-5769412d8721 11584-1032 HUMAN OTC DRUG DESPEC Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20020402 OTC MONOGRAPH FINAL part341 International Ethical Laboratories, Inc. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 100; 5 mg/5mL; mg/5mL 11584-1045_8f035f1a-6229-42af-9144-64bd10f01850 11584-1045 HUMAN OTC DRUG DESPEC DM Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SYRUP ORAL 20021101 20150830 OTC MONOGRAPH FINAL part341 International Ethical Laboratories, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 100; 5 mg/5mL; mg/5mL; mg/5mL 11584-1046_aeb2682a-f929-4299-8ba4-195daf73310d 11584-1046 HUMAN OTC DRUG DESPEC DM Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SYRUP ORAL 20140102 OTC MONOGRAPH FINAL part341 International Ethical Laboratories, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 11584-1060_11fbc063-7d2d-4d86-bdc7-f2f37da44bee 11584-1060 HUMAN OTC DRUG Despec NR Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20080420 OTC MONOGRAPH FINAL part341 International Ethical Laboratories DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 4; 20; 1.5 mg/5mL; mg/5mL; mg/5mL 11584-1080_d29cf6e6-ed49-4cdd-86e2-85ed049c6e83 11584-1080 HUMAN OTC DRUG Despec-Tab Guaifenesin, Pseudoephedrine Hydrochloride TABLET ORAL 20111202 OTC MONOGRAPH FINAL part341 International Ethical Labs GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 400; 40 mg/1; mg/1 11584-1100_855d5c0b-b432-46b1-b7df-cfc18e26f8e7 11584-1100 HUMAN OTC DRUG Despec DM Tabs Dextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride TABLET ORAL 20111208 OTC MONOGRAPH FINAL part341 International Ethical Labs DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 30; 400; 40 mg/1; mg/1; mg/1 11584-1110_29ff4568-9a18-4e96-8c89-944880bd385e 11584-1110 HUMAN OTC DRUG Despec EDA Drops Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20120119 OTC MONOGRAPH FINAL part341 International Ethical Labs DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 50; 2.5 mg/mL; mg/mL; mg/mL 11673-000_f1813b03-bbc3-44d8-b2ae-4d38e5a7d319 11673-000 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20100707 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 11673-001_1649cc23-5365-4509-9ce0-78eafda342a0 11673-001 HUMAN OTC DRUG Foaming Hand Wash Triclosan 0.46% LIQUID TOPICAL 20120806 OTC MONOGRAPH NOT FINAL part333A Target Corp TRICLOSAN .46 mg/mL 11673-002_73933cde-8b56-4d7d-a277-8d4f037a73fc 11673-002 HUMAN OTC DRUG up and up ready to use enema Dibasic sodium phosphate, Monobasic sodium phosphate ENEMA RECTAL 20120126 OTC MONOGRAPH NOT FINAL part334 Target Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 11673-003_6daf078f-6151-484d-afc5-e00a9bac3488 11673-003 HUMAN OTC DRUG First Aid Antiseptic POVIDONE-IODINE SOLUTION TOPICAL 20040122 OTC MONOGRAPH NOT FINAL part333E Target Corporation POVIDONE-IODINE 10 mg/mL 11673-004_746b3654-eeea-4d4a-b744-98ef2b591479 11673-004 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20110826 OTC MONOGRAPH FINAL part355 Target Corp SODIUM FLUORIDE 10.4 mg/mL 11673-008_e904c73e-0cf4-4b04-8a13-595c9248096a 11673-008 HUMAN OTC DRUG Up and Up infants acetaminophen Acetaminophen SUSPENSION/ DROPS ORAL 20090714 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 80 mg/.8mL 11673-009_ffbd44b9-ce49-4fc1-ba88-9467dc3f04da 11673-009 HUMAN OTC DRUG Liquid corn and Callus Remover Liquid corn and Callus Remover LIQUID TOPICAL 20130430 OTC MONOGRAPH FINAL part358F Target Corporation SALICYLIC ACID .17 g/g 11673-011_d63109ec-52ab-43ce-a5c5-c707cae854a6 11673-011 HUMAN OTC DRUG 2 in 1 Pyrithione zinc SHAMPOO TOPICAL 20130516 OTC MONOGRAPH FINAL part358H Target Corporation PYRITHIONE ZINC 10.4 mg/mL 11673-013_b0da1a97-dbe1-42d5-b1b9-f783cb58dac8 11673-013 HUMAN OTC DRUG Up and Up allergy and congestion relief Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120312 ANDA ANDA076050 Target Corporation LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 11673-015_75fb44a0-55b4-4c9b-9902-47ded325d063 11673-015 HUMAN OTC DRUG Healing petrolatum OINTMENT TOPICAL 20100107 OTC MONOGRAPH FINAL part347 Target Corporation PETROLATUM 340 mg/g 11673-020_f68a9057-3557-4ecb-9ce4-8d5dd8878fb0 11673-020 HUMAN OTC DRUG Diaper Rash Paste ZINC OXIDE PASTE TOPICAL 20080324 OTC MONOGRAPH NOT FINAL part347 Target Corporation ZINC OXIDE .1133 kg/100kg 11673-022_57e5bf0b-41c3-44ca-9e4a-ee59b13a901a 11673-022 HUMAN OTC DRUG Up and Up Acid Reducer Cimetidine TABLET ORAL 20100512 ANDA ANDA075285 Target Corporation CIMETIDINE 200 mg/1 11673-027_57e16f70-b23f-4989-b21a-5d1ccdc6409d 11673-027 HUMAN OTC DRUG Aspirin Enteric Safety-Coated Aspirin TABLET ORAL 20130308 OTC MONOGRAPH FINAL part343 TARGET Corporation ASPIRIN 81 mg/1 11673-029_87283114-7302-4de4-a64e-c8221b30137c 11673-029 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20100311 ANDA ANDA076775 Target Corporation NICOTINE 2 mg/1 11673-039_9ccb570b-1f07-42ca-b66a-bde534751159 11673-039 HUMAN OTC DRUG Childrens Allergy Dye Free Loratadine LIQUID ORAL 20141031 ANDA ANDA077421 TARGET Corporation LORATADINE 5 mg/5mL 11673-041_4627e47c-7eeb-48b9-9e3f-0517332d7d1b 11673-041 HUMAN OTC DRUG Target Cold/Flu Relief acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090709 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 11673-047_0a7733db-3b90-4169-a19b-97d693f86c03 11673-047 HUMAN OTC DRUG up and up ranitidine Ranitidine TABLET ORAL 20120503 ANDA ANDA078653 Target Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 11673-050_e44848ed-f808-4f30-99ca-b7f746e2cf98 11673-050 HUMAN OTC DRUG up and up ibuprofen pm diphenhydramine citrate and ibuprofen TABLET, COATED ORAL 20090710 ANDA ANDA079113 Target Corporation DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 11673-054_da4fec52-4fde-4688-bf04-f4b1d986e8e4 11673-054 HUMAN OTC DRUG up and up 12 hour nasal decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090902 ANDA ANDA075153 Target Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 11673-055_0915af59-99e2-43ff-8adc-3fe750ff0f1b 11673-055 HUMAN OTC DRUG moist wipes fresh scent Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Target Corp BENZALKONIUM CHLORIDE .115 g/1 11673-056_323e0575-152e-46dc-bb07-ab6828262a18 11673-056 HUMAN OTC DRUG up and up cold flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140205 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 11673-061_be3240ac-92f9-4176-a851-065d3780b094 11673-061 HUMAN OTC DRUG up and up famotidine Famotidine TABLET ORAL 20120503 ANDA ANDA077351 Target Corporation FAMOTIDINE 20 mg/1 11673-063_c76fd96c-c841-42c8-b3d8-b2d09405f4f6 11673-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19971126 OTC MONOGRAPH FINAL part347 Target Corporation FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL 11673-065_54548c96-bbe6-4c2f-ac4e-ff5b743269da 11673-065 HUMAN OTC DRUG up and up nasal extra moisturizing Oxymetazoline HCl SPRAY NASAL 20100721 OTC MONOGRAPH FINAL part341 Target Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 11673-067_0927c0ef-e32f-47a4-88d5-65552af5fbb8 11673-067 HUMAN OTC DRUG up and up antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20091026 OTC MONOGRAPH FINAL part333B Target Corporation BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 11673-069_201a0250-99d8-439e-b39c-a63c0ca2357c 11673-069 HUMAN OTC DRUG Pure petroleum White Petrolatum JELLY TOPICAL 20050602 OTC MONOGRAPH FINAL part347 Target Corp PETROLATUM 1 g/g 11673-071_2f72578a-290a-48da-bbc4-647124c93770 11673-071 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part333A target Corp ALCOHOL 567 mg/mL 11673-072_4bc7cec0-4c19-4258-8245-82a2f1089e77 11673-072 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19960108 OTC MONOGRAPH NOT FINAL part356 Target Corp EUCALYPTOL; 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mg/1; mg/1 11673-086_69261d6a-7ed8-42f8-b313-e95379e17e9d 11673-086 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140314 OTC MONOGRAPH NOT FINAL part333A Target Corp ALCOHOL 567 mg/mL 11673-090_41c6aba0-2439-4a0f-9c28-640ee449d98d 11673-090 HUMAN OTC DRUG Up and UP Anticavity Toothpaste Whitening Plus Mouthwash Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110531 OTC MONOGRAPH FINAL part355 Target Corporation SODIUM FLUORIDE 2.43 mg/g 11673-092_b5fadc76-6bfe-48ef-97f0-fc8b7b33e524 11673-092 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Target Corporation LORATADINE 5 mg/5mL 11673-094_530d4a95-a63b-4b2f-82de-584add426a40 11673-094 HUMAN OTC DRUG Up and Up nasal decongestant PE Phenylephrine Hydrochloride TABLET ORAL 20090612 OTC MONOGRAPH FINAL part341 Target Corporation PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 11673-096_44cb446f-96f5-4af7-b167-5f6c2f747c69 11673-096 HUMAN OTC DRUG up and up flu and severe cold and cough relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20110206 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 11673-098_2877d530-357e-4c24-836d-2cb996c32457 11673-098 HUMAN OTC DRUG Up and Up Medicated Hemorrhoidal Pads WITCH HAZEL SWAB TOPICAL 20111113 OTC MONOGRAPH FINAL part346 TARGET CORPORATION WITCH HAZEL 1 g/1 11673-099_6b29cfc4-5aef-4f32-8c9f-311c1c37b495 11673-099 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20140406 OTC MONOGRAPH NOT FINAL part333A Target Corporation BENZALKONIUM CHLORIDE 1.3 g/mL 11673-102_14692d83-36df-49a7-a2ad-7c9987ef4be1 11673-102 HUMAN OTC DRUG Target Childrens All Day Allergy Relief Sugar Free Grape Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Target Corporation CETIRIZINE HYDROCHLORIDE 1 mg/mL 11673-105_a0173c86-3806-4242-865f-054ddf58ed54 11673-105 HUMAN OTC DRUG Up and Up childrens acetaminophen oral suspension Acetaminophen SUSPENSION ORAL 20090708 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 160 mg/5mL 11673-106_3d7eb25d-fe73-4084-b859-9e15cde547ba 11673-106 HUMAN OTC DRUG up and up childrens all day allergy relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Target Corporation CETIRIZINE HYDROCHLORIDE 1 mg/mL 11673-107_fd24db6f-21d5-4001-a5b3-4dd6e921cf07 11673-107 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20131130 OTC MONOGRAPH FINAL part341 TARGET Corporation GUAIFENESIN 400 mg/1 11673-109_d951cc21-d965-46c9-be78-ffc496f499bc 11673-109 HUMAN OTC DRUG Mucus and Cough Relief Dextromethorphan Hydrobromide and Guaifenesin TABLET ORAL 20131130 OTC MONOGRAPH FINAL part341 TARGET Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 11673-113_1b8201d0-9bb6-4e5f-a21c-9901b6a8f767 11673-113 HUMAN OTC DRUG up and up nighttime flu and severe cold and cough Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 11673-117_7dd07d88-bdd3-496c-ba70-165fa69ec9de 11673-117 HUMAN OTC DRUG up and up lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 Target Corporation LANSOPRAZOLE 15 mg/1 11673-120_d2ae0892-1f53-4df3-9291-7643069f9334 11673-120 HUMAN OTC DRUG WOMENS LAXATIVE Bisacodyl TABLET, COATED ORAL 20100721 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation BISACODYL 5 mg/1 11673-124_eaebbd6c-4030-4623-84c4-e244ed3475a8 11673-124 HUMAN OTC DRUG up and up nicotine polacrilex Nicotine Polacrilex LOZENGE ORAL 20110221 ANDA ANDA090711 Target Corporation NICOTINE 2 mg/1 11673-127_8b2337b2-468c-4c1a-9e85-d3b380bf5d75 11673-127 HUMAN OTC DRUG up and up pain relief ultra strength camphor, menthol, methyl salicylate CREAM TOPICAL 20100119 OTC MONOGRAPH NOT FINAL part348 Target Corporation CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g 11673-130_7d173cf5-c788-4144-9d74-85a1119169ca 11673-130 HUMAN OTC DRUG Up and Up Childrens acetaminophen Acetaminophen SUSPENSION ORAL 20090708 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 160 mg/5mL 11673-131_975ca696-f70e-a44b-8faf-2892e0fd0b1b 11673-131 HUMAN OTC DRUG Ranitidine 75 Ranitidine Tablets USP, 75mg TABLET ORAL 20131122 ANDA ANDA075294 Target Brands Inc RANITIDINE HYDROCHLORIDE 75 mg/1 11673-136_64286944-2d52-4dd9-8b53-cff3550fceaf 11673-136 HUMAN OTC DRUG up and up pain relief extra strength menthol, methyl salicylate CREAM TOPICAL 20080514 OTC MONOGRAPH NOT FINAL part348 Target Corporation MENTHOL; METHYL SALICYLATE 100; 300 mg/g; mg/g 11673-137_a8107155-e901-414b-beb5-1aa65f2e8739 11673-137 HUMAN OTC DRUG up and up pain relief odorless Trolamine salicylate CREAM TOPICAL 20090127 UNAPPROVED DRUG OTHER Target Corporation TROLAMINE SALICYLATE 100 mg/g 11673-141_361ac581-5fcf-43ab-b6a5-15e3bce88169 11673-141 HUMAN OTC DRUG Alcohol Prep Pads benzocaine SWAB TOPICAL 20100219 OTC MONOGRAPH NOT FINAL part348 Target Corporation BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 11673-142_7bdd406b-1af8-4015-8aab-7c37b40a257f 11673-142 HUMAN OTC DRUG Up and up vagicaine Benzocaine, Resorcinol CREAM TOPICAL 20090825 OTC MONOGRAPH NOT FINAL part348 Target Corporation BENZOCAINE; RESORCINOL 20; 3 g/100g; g/100g 11673-145_67b38ff1-78d6-43b6-ac31-f2e60eb81448 11673-145 HUMAN OTC DRUG Up and Up Mucus Relief Cold and Sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130924 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 11673-153_1cadd164-f2d8-4499-b060-acd5e88919a8 11673-153 HUMAN OTC DRUG Everyday Clean Dandruff pyrithione zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Target Corporation PYRITHIONE ZINC 10.4 mg/mL 11673-159_d240c0fe-5270-46f2-a657-54ab2e582021 11673-159 HUMAN OTC DRUG Pain Reliever Added Strength Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 11673-160_1bd6a720-b3fe-467e-aef5-da85f86d43ae 11673-160 HUMAN OTC DRUG Senna Laxative plus Stool Softener DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20100317 OTC MONOGRAPH NOT FINAL part334 Target Corporation DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 11673-163_6164a0e8-2d44-448f-a061-f7ff43e81669 11673-163 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 19940406 OTC MONOGRAPH FINAL part355 Target Corporation SODIUM FLUORIDE 1 mg/mL 11673-165_96aae740-2b6a-4166-a1ef-badd56b21f3b 11673-165 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Target Corporation LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 11673-166_78e4e1f2-bf87-4337-b248-64c4e92a3259 11673-166 HUMAN OTC DRUG Up and Up childrens ibuprofen Ibuprofen SUSPENSION ORAL 20090612 ANDA ANDA074937 Target Corporation IBUPROFEN 100 mg/5mL 11673-170_6441960f-abc7-4b44-a92f-366eeaa8825e 11673-170 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20100312 ANDA ANDA076789 Target Corporation NICOTINE 4 mg/1 11673-173_4954a3f2-8d27-4955-ab88-2518b8a05252 11673-173 HUMAN OTC DRUG Lice Complete Piperonyl Butoxide, Pyrethrum Extract KIT 20110206 OTC MONOGRAPH FINAL part358G Target Corporation 11673-173_ab133226-a9a8-483a-bd22-31fc1555bf6e 11673-173 HUMAN OTC DRUG up and up lice complete kit 1 2 3 Piperonyl Butoxide, Pyrethrum Extract KIT 20110206 OTC MONOGRAPH FINAL part358G Target Corporation 11673-174_bd651fc5-6aaa-4a96-b3a5-910d451511b3 11673-174 HUMAN OTC DRUG Up and Up womens laxative Bisacodyl TABLET, COATED ORAL 20090708 OTC MONOGRAPH NOT FINAL part334 Target Corporation BISACODYL 5 mg/1 11673-175_ec5b99c3-12f1-4754-aae6-dc4cb3989124 11673-175 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141230 NDA NDA021920 TARGET Corporation NAPROXEN SODIUM 220 mg/1 11673-176_a6bd079d-81c9-4f71-87c1-6553f08dc21b 11673-176 HUMAN OTC DRUG Up and Up all day allergy relief d Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20090728 ANDA ANDA077170 Target Corporation CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 11673-180_4477745e-7beb-4a75-a31b-cf1398848ab1 11673-180 HUMAN OTC DRUG Senna Laxative SENNOSIDES TABLET ORAL 20130830 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation SENNOSIDES 8.6 mg/1 11673-183_98de2d1f-03c9-4051-b220-2a7acd423a63 11673-183 HUMAN OTC DRUG up and up ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20100311 ANDA ANDA077349 Target Corporation IBUPROFEN 200 mg/1 11673-190_c3d308d6-31de-4e20-9abd-506ac8a0b63d 11673-190 HUMAN OTC DRUG up and up nicotine polacrilex Nicotine Polacrilex LOZENGE ORAL 20110312 ANDA ANDA090711 Target Corporation NICOTINE 4 mg/1 11673-194_997af278-7277-4c1f-8101-cf810e058ac9 11673-194 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20000216 NDA NDA020165 Target Corporation NICOTINE 21 mg/24h 11673-195_997af278-7277-4c1f-8101-cf810e058ac9 11673-195 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20000216 NDA NDA020165 Target Corporation NICOTINE 14 mg/24h 11673-196_997af278-7277-4c1f-8101-cf810e058ac9 11673-196 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20000216 NDA NDA020165 Target Corporation NICOTINE 7 mg/24h 11673-197_bedcc735-6867-476b-b539-1fd45e2b6099 11673-197 HUMAN OTC DRUG Ibuprofen IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20100801 ANDA ANDA078682 TARGET Corporation IBUPROFEN 200 mg/1 11673-198_ebc300d4-5f04-4fdb-a70f-fbe54904b354 11673-198 HUMAN OTC DRUG Motion Sickness Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 Target Corporation DIMENHYDRINATE 50 mg/1 11673-199_4f2fd41a-fa32-4dca-be40-b1c11fd61bed 11673-199 HUMAN OTC DRUG up and up miconazole Miconazole nitrate KIT 20100708 ANDA ANDA079114 Target Corporation 11673-201_e9e300b8-693a-4115-ae21-85b42fc79749 11673-201 HUMAN OTC DRUG up and up acid reducer original strength Famotidine TABLET ORAL 20091013 ANDA ANDA075400 Target Corporation FAMOTIDINE 10 mg/1 11673-203_eccf77cf-b212-4a94-9c63-43fbaa80ba9e 11673-203 HUMAN OTC DRUG Antiacterial Hand Sanitizer Alcohol GEL TOPICAL 20110907 OTC MONOGRAPH NOT FINAL part333A Target Corp ALCOHOL .65 mL/100L 11673-205_0d1dba67-512d-4f4f-8cbf-379465c73742 11673-205 HUMAN OTC DRUG Therapeutic T Plus Coal Tar SHAMPOO TOPICAL 20070129 OTC MONOGRAPH FINAL part358H Target Corp COAL TAR 25 mg/mL 11673-206_a4809ad2-d93b-4231-aba4-e3839be45f28 11673-206 HUMAN OTC DRUG up and up nicotine polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20111006 ANDA ANDA078325 Target Corporation NICOTINE 2 mg/1 11673-207_5f2a2afe-a779-4437-af32-dc6d9a64fc30 11673-207 HUMAN OTC DRUG Up and Up acid reducer original strength Famotidine TABLET, COATED ORAL 20090709 ANDA ANDA075312 Target Corporation FAMOTIDINE 10 mg/1 11673-208_d881cc46-4642-4167-8b1e-dfcb06ce8be4 11673-208 HUMAN OTC DRUG Childrens All Day Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Target Corporation CETIRIZINE HYDROCHLORIDE 1 mg/mL 11673-211_be406ebb-82bf-41a5-a9fd-6fcff43b764d 11673-211 HUMAN OTC DRUG Allergy Relief Cetirizine HCl CAPSULE, LIQUID FILLED ORAL 20140930 NDA NDA022429 TARGET Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 11673-213_34eb710c-ba6b-4bee-a9dd-c055b5b3a0eb 11673-213 HUMAN OTC DRUG Fluoride Mouth Rinse Anticavity Sodium Fluoride MOUTHWASH ORAL 20100817 OTC MONOGRAPH FINAL part355 Target Corp. SODIUM FLUORIDE .2 mg/mL 11673-214_05a830d3-a75d-40db-8156-f33ec1c3ce53 11673-214 HUMAN OTC DRUG Smooth and glossy pyrithione zinc SHAMPOO TOPICAL 19991012 OTC MONOGRAPH FINAL part358H Target Corporation PYRITHIONE ZINC 10.4 mg/mL 11673-215_f144312d-4be3-4ce1-9df1-748d4d32b3ff 11673-215 HUMAN OTC DRUG Up and Up Cold Flu Relief Multi Symptom Day Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20100805 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 11673-217_bbd37667-9b50-4ca7-84e6-cc65cb1d596e 11673-217 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110914 ANDA ANDA079174 TARGET Corporation IBUPROFEN 200 mg/1 11673-218_00e936d5-1880-4338-a28a-8e60230e8146 11673-218 HUMAN OTC DRUG Clear Anti-Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 19960331 OTC MONOGRAPH NOT FINAL part347 Target Cop PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 1; .1 mL/100L; mL/100L 11673-222_ebd1f81d-8d9e-4e9f-a7ab-b1a8d83b055b 11673-222 HUMAN OTC DRUG Ready-to-Use Enema Sodium Phosphate ENEMA RECTAL 20120823 OTC MONOGRAPH NOT FINAL part334 Target Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 11673-224_2de5f58b-89a2-4a6e-9193-31e69154f1e8 11673-224 HUMAN OTC DRUG Up and Up anti diarrheal Loperamide Hydrochloride TABLET ORAL 20090720 ANDA ANDA075232 Target Corporation LOPERAMIDE HYDROCHLORIDE 2 mg/1 11673-226_b5613dc7-b8b0-4070-87cf-321a808d7627 11673-226 HUMAN OTC DRUG Diaper Rash Zinc oxide CREAM TOPICAL 19940808 OTC MONOGRAPH FINAL part347 Target Corporation ZINC OXIDE 130 mg/g 11673-227_e5bd439c-b034-44f6-9ba1-c624438e58f0 11673-227 HUMAN OTC DRUG up and up acetaminophen extra strength Acetaminophen TABLET, COATED ORAL 20090520 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 500 mg/1 11673-229_96b15aea-a460-4999-87ca-cc6fbaa23ab2 11673-229 HUMAN OTC DRUG NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING ORAL 20100215 NDA NDA018612 Target Corporation NICOTINE 2 mg/1 11673-230_96b15aea-a460-4999-87ca-cc6fbaa23ab2 11673-230 HUMAN OTC DRUG NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING ORAL 20100215 NDA NDA020066 Target Corporation NICOTINE 4 mg/1 11673-236_d036bb5d-e03e-428b-95c2-39134831e82c 11673-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 TARGET Corporation DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 11673-238_fcffb305-517c-4a71-8a89-d2436ec5d58f 11673-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130715 OTC MONOGRAPH NOT FINAL part334 Target Corporation DOCUSATE SODIUM 100 mg/1 11673-243_794345da-4296-4aca-bef4-f98188b5b4bf 11673-243 HUMAN OTC DRUG Maximum Strength Wart Remover Strips Wart Remover Strips PLASTER TOPICAL 20111231 OTC MONOGRAPH FINAL part358B Target Corporation SALICYLIC ACID .4 g/g 11673-245_b1126ec0-6746-4b46-85fb-cb92eecee74d 11673-245 HUMAN OTC DRUG Laxative pills Maximum Strength Sennosides TABLET ORAL 20131130 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation SENNOSIDES 25 mg/1 11673-246_e510566a-1aa0-41d6-994f-ed371533f25d 11673-246 HUMAN OTC DRUG Medicated Dandruff Selenium Sulfide SHAMPOO TOPICAL 19900215 OTC MONOGRAPH FINAL part358H Target Corp SELENIUM SULFIDE 1 kg/100L 11673-247_c3a8a8b1-5308-4f98-ae83-a439cbebefb2 11673-247 HUMAN OTC DRUG Headache Relief Acetaminophen, Aspirin, Caffeine TABLET ORAL 20141130 OTC MONOGRAPH NOT FINAL part343 TARGET Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 11673-248_90b65589-8b12-4fcc-80cc-d438ebe57d7e 11673-248 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20131130 ANDA ANDA079174 TARGET Corporation IBUPROFEN 200 mg/1 11673-249_07c44dc8-b1bd-491f-9c43-fdf55e6c4cc8 11673-249 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20140328 ANDA ANDA079174 TARGET Corporation IBUPROFEN 200 mg/1 11673-250_a26261a5-669e-4aa0-9de1-9d62f93142b7 11673-250 HUMAN OTC DRUG up and up cold relief Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20090731 OTC MONOGRAPH FINAL part341 Target Corporation 11673-250_ca24a510-e97e-4aed-bb0f-2bcc7545162f 11673-250 HUMAN OTC DRUG up and up cold relief Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20090731 OTC MONOGRAPH FINAL part341 Target Corporation 11673-255_6cfdcd94-95cb-4447-a14b-cdb49a1e3114 11673-255 HUMAN OTC DRUG up and up dye free infants concentrated ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20090708 ANDA ANDA075217 Target Corporation IBUPROFEN 50 mg/1.25mL 11673-259_a3d38150-f3b9-4108-9db9-ec0ba459fa29 11673-259 HUMAN OTC DRUG Undecylenic Acid Maximum Strength Antifungal Liquid Solution LIQUID TOPICAL 20140601 OTC MONOGRAPH FINAL part333C Target Corporation UNDECYLENIC ACID 25 mg/30mL 11673-260_94c09948-25d7-4828-bdcd-9043165be752 11673-260 HUMAN OTC DRUG Maximum Strength Antifungal Pen LIQUID TOPICAL 20140401 OTC MONOGRAPH FINAL part333C Target Corporation UNDECYLENIC ACID 25 mg/1.7mL 11673-263_a117bec8-7407-452c-beca-f55fc222ccef 11673-263 HUMAN OTC DRUG PREMIUM HAND SANITIZER NECTARINE MINT ETHYL ALCOHOL GEL TOPICAL 20110321 OTC MONOGRAPH NOT FINAL part333E TARGET ALCOHOL 62 mL/100mL 11673-263_ba07932b-800b-44cc-a393-78c17d22343e 11673-263 HUMAN OTC DRUG PREMIUM HAND SANITIZER NECTARINE MINT ETHYL ALCOHOL GEL TOPICAL 20110321 OTC MONOGRAPH NOT FINAL part333E TARGET ALCOHOL 62 mL/100mL 11673-264_a9cf7c2f-3811-4304-886a-27fd82df28f0 11673-264 HUMAN OTC DRUG PREMIUM HAND SANITIZER CUCUMBER GREEN TEA ETHYL ALCOHOL GEL TOPICAL 20110321 OTC MONOGRAPH NOT FINAL part333E TARGET ALCOHOL 62 mL/100mL 11673-264_ccce270e-928c-4e78-be2e-91d316e6eaf4 11673-264 HUMAN OTC DRUG PREMIUM HAND SANITIZER CUCUMBER GREEN TEA ETHYL ALCOHOL GEL TOPICAL 20110321 OTC MONOGRAPH NOT FINAL part333E TARGET ALCOHOL 62 mL/100mL 11673-271_e83854ad-c2e4-415c-a58b-fa81128f04f7 11673-271 HUMAN OTC DRUG UP AND UP ACID REDUCER NON PRESCRIPTION STRENGTH Ranitidine TABLET ORAL 20090731 ANDA ANDA076760 Target Corporation RANITIDINE HYDROCHLORIDE 75 mg/1 11673-272_872ba4c4-0787-4ee2-884d-5f0dd63d7ef4 11673-272 HUMAN OTC DRUG up and up sinus congestion and pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20090708 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 11673-277_ca426222-b81f-44ae-ac8b-5ae075d3086a 11673-277 HUMAN OTC DRUG up and up aspirin Aspirin TABLET, FILM COATED ORAL 20090722 OTC MONOGRAPH NOT FINAL part343 Target Corporation ASPIRIN 81 mg/1 11673-279_d56ecdfd-5c77-41e0-a42c-d135d9f0a817 11673-279 HUMAN OTC DRUG up and up hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140523 OTC MONOGRAPH FINAL part346 Target Corporation COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 11673-281_ade323f0-bca7-4125-ab30-3636498b67d6 11673-281 HUMAN OTC DRUG Pyrithione Zinc Dry Scalp SHAMPOO TOPICAL 20020718 OTC MONOGRAPH FINAL part358H Target Corporation PYRITHIONE ZINC 1 kg/100L 11673-288_dae1bf82-88a1-4c5e-8468-d6b606bdacbd 11673-288 HUMAN OTC DRUG up and up childrens mucus relief Guaifenesin LIQUID ORAL 20090724 OTC MONOGRAPH FINAL part341 Target Corporation GUAIFENESIN 100 mg/5mL 11673-289_9ab25460-333b-4d6f-9244-64d6266a0365 11673-289 HUMAN OTC DRUG Up and Up infants acetaminophen Acetaminophen SUSPENSION/ DROPS ORAL 20090612 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 80 mg/.8mL 11673-294_57fc1700-61cc-4613-b569-babd367029f6 11673-294 HUMAN OTC DRUG up and up minoxidil Minoxidil AEROSOL, FOAM TOPICAL 20120301 ANDA ANDA091344 Target Corporation MINOXIDIL 5 g/100g 11673-296_32a8eaf3-665c-4770-b234-28fac6264d3d 11673-296 HUMAN OTC DRUG up and up tussin multi symptom cold maximum strength dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20121217 OTC MONOGRAPH FINAL part341 Target Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL 11673-297_2e29b258-c7cc-47b5-b6ed-af4145b66316 11673-297 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333A Target Corporation ALCOHOL 567 mg/mL 11673-299_b9ed54fe-aaa0-4edd-bb0e-e7ca3dcfa71e 11673-299 HUMAN OTC DRUG Antiseptic Cetylpyridinium chloride MOUTHWASH ORAL 20080721 OTC MONOGRAPH NOT FINAL part356 Target Corporation CETYLPYRIDINIUM CHLORIDE .7 mg/mL 11673-299_cd4e02c6-3fed-4ab5-aee8-1306c4ff5b46 11673-299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 20080721 OTC MONOGRAPH NOT FINAL part356 Target Corporation CETYLPYRIDINIUM CHLORIDE .07 kg/100L 11673-300_ffbaa482-0335-48c6-9f05-d6c0dbab986f 11673-300 HUMAN OTC DRUG Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20070308 OTC MONOGRAPH FINAL part347 Target Corp LANOLIN; PETROLATUM 133; 459 mg/g; mg/g 11673-302_90ce6e67-4e40-459e-90d4-4eea5aa91c5e 11673-302 HUMAN OTC DRUG Up and Up Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 20130213 OTC MONOGRAPH FINAL part335 Target Corporation BISMUTH SUBSALICYLATE 525 mg/30mL 11673-304_01b7dbd7-05a3-4681-8b4e-65f9d6669042 11673-304 HUMAN OTC DRUG Up and up nasal oxymetazoline hydrochloride SPRAY NASAL 20090812 OTC MONOGRAPH FINAL part341 Target Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 11673-306_38a0f742-4830-4d5a-837d-07914d1b0e87 11673-306 HUMAN OTC DRUG up and up powderlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 Target Corporation POLYETHYLENE GLYCOL 3350 17 g/17g 11673-311_cf728502-2f76-4e09-b597-979e1dbbf4a6 11673-311 HUMAN OTC DRUG up and up allergy relief Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20090616 ANDA ANDA075990 Target Corporation LORATADINE 10 mg/1 11673-315_ee04c89a-3dce-4c6a-949d-612fdb1068e4 11673-315 HUMAN OTC DRUG allergy relief medication loratadine TABLET ORAL 20100131 ANDA ANDA075209 Target Brands, Inc. LORATADINE 10 mg/1 11673-318_96c82069-1818-493c-986f-59174a83a2ec 11673-318 HUMAN OTC DRUG Antiseptic Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 19960715 OTC MONOGRAPH NOT FINAL part356 Target Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 11673-319_08aa94dd-d703-49a8-8329-8dce00c232c4 11673-319 HUMAN OTC DRUG Up and Up anti itch Hydrocortisone CREAM TOPICAL 20091109 OTC MONOGRAPH NOT FINAL part348 Target Corporation HYDROCORTISONE 1 g/100g 11673-321_43872a63-e3ad-4df8-ab58-3ecb8565045c 11673-321 HUMAN OTC DRUG Up and Up dual action acid controller complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20090626 ANDA ANDA077355 Target Corporation CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 11673-330_90ffc734-cc35-4d46-9278-6eaf4ccdbc96 11673-330 HUMAN OTC DRUG Healing PETROLATUM JELLY TOPICAL 20120103 OTC MONOGRAPH FINAL part346 TARGET CORPORATION PETROLATUM 41 g/100g 11673-330_ab9cb71d-5692-477f-b1b5-f0e7fa064c84 11673-330 HUMAN OTC DRUG Healing PETROLATUM JELLY TOPICAL 20120103 OTC MONOGRAPH FINAL part346 TARGET CORPORATION PETROLATUM 41 g/100g 11673-332_586953e8-e15b-415d-b49e-68d71e3473c7 11673-332 HUMAN OTC DRUG UP and UP CREAMY DIAPER RASH ZINC OXIDE OINTMENT TOPICAL 20120423 OTC MONOGRAPH FINAL part346 TARGET CORPORATION ZINC OXIDE 13 g/100g 11673-334_8f5f8e5f-06da-4888-9bcd-51b216608bf4 11673-334 HUMAN OTC DRUG UP and UP DIAPER RASH ZINC OXIDE OINTMENT TOPICAL 20120420 OTC MONOGRAPH FINAL part346 TARGET CORPORATION ZINC OXIDE 40 g/100g 11673-335_6110ac09-af90-406d-b083-7b29f03861d2 11673-335 HUMAN OTC DRUG up and up cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110923 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 11673-340_89911c15-f5cf-4013-b4da-0fbf0b7383dd 11673-340 HUMAN OTC DRUG UP AND UP DIAPER RASH LANOLIN, PETROLATUM OINTMENT TOPICAL 20120430 OTC MONOGRAPH FINAL part347 TARGET CORPORATION LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g 11673-344_1ed262ff-4e02-4866-bc1f-49baa730d467 11673-344 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex LOZENGE ORAL 20090616 ANDA ANDA077007 Target Corporation NICOTINE 2 mg/1 11673-350_8ffe3f78-5eba-44c9-be6e-c57564317d06 11673-350 HUMAN OTC DRUG UP and UP PETROLATUM JELLY TOPICAL 20120103 OTC MONOGRAPH FINAL part346 TARGET CORPORATION PETROLATUM 99.9 g/100g 11673-351_351b3079-392d-47ef-b8da-6cab3df04b20 11673-351 HUMAN OTC DRUG UP AND UP PETROLEUM WHITE PETROLATUM JELLY TOPICAL 20120413 OTC MONOGRAPH FINAL part346 TARGET CORPORATION PETROLATUM 99.6 g/100g 11673-352_c4c9351b-3ee1-4bbb-8e94-cc0f99c0de50 11673-352 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20110210 ANDA ANDA078547 Target Corporation NICOTINE 2 mg/1 11673-357_0a70e706-72c5-4f64-bdff-e40b4fc338a1 11673-357 HUMAN OTC DRUG up and up antacid anti gas regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20090616 OTC MONOGRAPH FINAL part332 Target Corporation ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 11673-358_69d9e095-df16-4ea9-a823-e96613a85d57 11673-358 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part333A Target Corporation BENZALKONIUM CHLORIDE .999 mg/mL 11673-359_69bbb4b9-336a-42ca-bc04-1aad4cb27296 11673-359 HUMAN OTC DRUG Up and Up adult cough formula DM Non drowsy Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20090709 OTC MONOGRAPH FINAL part341 Target Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 11673-365_34223438-1e9d-46d1-9908-ae60da4940ab 11673-365 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20130809 ANDA ANDA091349 Target Corporation NICOTINE 2 mg/1 11673-367_054dece9-dc2c-47c4-99ab-afe83e057718 11673-367 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 11673-368_bc325975-55f7-4485-889f-5664c43ce4f0 11673-368 HUMAN OTC DRUG up and up naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20090624 ANDA ANDA074661 Target Corporation NAPROXEN SODIUM 220 mg/1 11673-369_38fc38e0-e1b4-4f69-9ec7-b7797134e3c5 11673-369 HUMAN OTC DRUG up and up anti itch Hydrocortisone CREAM TOPICAL 20110317 OTC MONOGRAPH NOT FINAL part348 Target Corporation HYDROCORTISONE 1 g/100g 11673-370_7d6f93ff-9dc7-41bc-a01f-c9f1aa8f0468 11673-370 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20121213 OTC MONOGRAPH NOT FINAL part333A Target Corp ALCOHOL 70 mL/100mL 11673-371_e98ab33c-08c1-4d55-a0fe-edfc6ecd6d4f 11673-371 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin TABLET, COATED ORAL 20110405 OTC MONOGRAPH FINAL part343 TARGET Corporation ASPIRIN 325 mg/1 11673-373_410c9b5e-4591-4a1a-8e4b-64fa4602cb22 11673-373 HUMAN OTC DRUG Pain Relief PM Acetaminophen and Diphenhydramine Citrate TABLET ORAL 20040607 OTC MONOGRAPH FINAL part338 Target Corporation ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 11673-374_93932b38-04ef-44bf-8e99-fd9bec60f53d 11673-374 HUMAN OTC DRUG Up and Up Migraine Relief Acetaminophen, Aspirin, Caffeine TABLET ORAL 20090612 ANDA ANDA075794 Target Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 11673-377_3a759463-f622-4f15-a34f-0bf8e3af7942 11673-377 HUMAN OTC DRUG Up and Up anti diarrheal Loperamide HCl SOLUTION ORAL 20090731 ANDA ANDA073243 Target Corporation LOPERAMIDE HYDROCHLORIDE 1 mg/5mL 11673-379_e0855dbe-15b8-4cc5-ab99-d8ea6f08d225 11673-379 HUMAN OTC DRUG Up and Up Childrens allergy medication Diphenhydramine Hydrochloride LIQUID ORAL 20090708 OTC MONOGRAPH FINAL part341 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 11673-380_81fa4fbf-9296-443b-8daa-c379b0609769 11673-380 HUMAN OTC DRUG up and up minoxidil Minoxidil SOLUTION TOPICAL 20090520 ANDA ANDA075598 Target Corporation MINOXIDIL 5 g/100mL 11673-381_befbca3f-6f4b-4a6f-a2c7-46df53f91a35 11673-381 HUMAN OTC DRUG Up and Up Mucus Relief Cold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130731 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 11673-383_32c2012e-6950-432d-b329-de438fb525b5 11673-383 HUMAN OTC DRUG Foaming Hand Wash Antibacterial Triclosan LIQUID TOPICAL 19930319 OTC MONOGRAPH NOT FINAL part333A Target Corporation TRICLOSAN 6 mg/mL 11673-384_5a9ae63b-5564-4242-9759-c1b20e16fa3c 11673-384 HUMAN OTC DRUG up and up cough suppressant dm dextromethorphan polistirex SUSPENSION ORAL 20121023 ANDA ANDA091135 Target Corporation DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 11673-390_d635efa3-27e6-4e8a-a607-ada9ad2d7f3d 11673-390 HUMAN OTC DRUG Menstrual Relief Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 11673-394_92ede62f-582d-4d85-8999-b0ab74932af1 11673-394 HUMAN OTC DRUG phenylephrine hydrochloride phenylephrine hydrochloride SUPPOSITORY RECTAL 20090901 OTC MONOGRAPH FINAL part346 Target Corporation COCOA BUTTER; 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NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 11673-407_58d0ac6b-2075-4034-82a5-c0c25578e4af 11673-407 HUMAN OTC DRUG Up and Up Cold Sore Treatment Camphor CREAM TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Target BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g 11673-408_247dec93-8e51-45a5-93bb-0d93f13bbf77 11673-408 HUMAN OTC DRUG Saline Wash Sodium Bicarbonate, Sodium Chloride POWDER, FOR SOLUTION ORAL 20130401 UNAPPROVED DRUG OTHER Target Corporation SODIUM BICARBONATE; SODIUM CHLORIDE 2300; 700 mg/1; mg/1 11673-413_739e139b-e06c-423c-948a-50b0ba51ba1b 11673-413 HUMAN OTC DRUG up and up ibuprofen pm Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20110716 ANDA ANDA079113 Target Corporation DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 11673-416_4308f2e2-72a6-481d-8395-b8219b8bc1c8 11673-416 HUMAN OTC DRUG Up and Up aspirin Aspirin TABLET ORAL 20090610 OTC MONOGRAPH NOT FINAL part343 Target Corporation ASPIRIN 325 mg/1 11673-417_0922e52f-e2f6-4f79-886a-f3ce4a9e4b96 11673-417 HUMAN OTC DRUG Up and Up Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130830 ANDA ANDA076518 Target Corporation NAPROXEN SODIUM; 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CAFFEINE 500; 65 mg/1; mg/1 11673-430_346202d6-c09d-43a6-aacc-e9f8df776456 11673-430 HUMAN OTC DRUG Eye Allergy Relief Pheniramine Maleate and Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20100831 NDA NDA020065 Target Corporation NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL 11673-432_acd8404d-93fb-4ea2-99d6-07c5680c59b9 11673-432 HUMAN OTC DRUG UP AND UP nasal decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 20090804 OTC MONOGRAPH FINAL part341 Target Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 11673-434_075ce534-d859-46bb-b541-bdadf2862135 11673-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20140501 OTC MONOGRAPH NOT FINAL part356 Target Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 11673-437_7d37de30-ed31-4917-9eb8-9e93024c2d2f 11673-437 HUMAN OTC DRUG up and up acetaminophen pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20090626 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 11673-439_62005b1c-e028-46e7-ada9-c38a13371be8 11673-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20121213 OTC MONOGRAPH NOT FINAL part333A Target Corp ALCOHOL 700 mg/mL 11673-442_7773c8f8-cf6a-4649-a649-7e2c89903560 11673-442 HUMAN OTC DRUG Up and Up Nicotine Polacrilex Nicotine polacrilex GUM, CHEWING ORAL 20130809 ANDA ANDA091354 Target Corporation NICOTINE 4 mg/1 11673-443_1f5c7e39-b321-4e74-a395-e43c2587debb 11673-443 HUMAN OTC DRUG Salicylic acid Liquid Wart Remover LIQUID TOPICAL 20081231 OTC MONOGRAPH FINAL part358B Target Corporation SALICYLIC ACID 2.1 g/14.7mL 11673-444_82c574ce-c386-4176-a879-0395fb6c4e26 11673-444 HUMAN OTC DRUG up and up acetaminophen Acetaminophen TABLET ORAL 20140820 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 325 mg/1 11673-447_a7ab3be2-accf-496b-ac8f-ecd3f0b534c7 11673-447 HUMAN OTC DRUG childrens acetaminophen melts Acetaminophen TABLET, ORALLY DISINTEGRATING ORAL 20050203 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 80 mg/1 11673-448_526752d9-9ff1-40a7-b63e-7a10492ee122 11673-448 HUMAN OTC DRUG Tolnaftate Antifungal Liquid Spray AEROSOL, SPRAY TOPICAL 20081231 OTC MONOGRAPH FINAL part333C Target Corporation TOLNAFTATE 1.5 g/150.2g 11673-449_cbb7d0c2-4bf8-423e-a185-95f9a558dc69 11673-449 HUMAN OTC DRUG Junior Strength Acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 160 mg/1 11673-450_ad87a939-40da-430a-8357-92ac189f7062 11673-450 HUMAN OTC DRUG junior strength acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 160 mg/1 11673-451_eb0cf606-1301-4be2-8791-e87ca0dd7b25 11673-451 HUMAN OTC DRUG lubricant and redness reliever Naphazoline Hydrochloride and Polyethylene glycol 300 SOLUTION/ DROPS OPHTHALMIC 20100913 OTC MONOGRAPH FINAL part349 Target Corporation NAPHAZOLINE HYDROCHLORIDE; POLYETHYLENE GLYCOL 300 .1; 2 mg/mL; mg/mL 11673-452_df44ff1b-e7ea-4ff7-b198-38eb86e8d78d 11673-452 HUMAN OTC DRUG Childrens Acetaminophen Melts Acetaminophen TABLET, CHEWABLE ORAL 20041206 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 80 mg/1 11673-454_e39fd7ad-58b8-468e-9a59-a8e57b8cb889 11673-454 HUMAN OTC DRUG Lubricant Eye Glycerin and propylene glycol SOLUTION/ DROPS OPHTHALMIC 20100901 OTC MONOGRAPH FINAL part349 Target Corporation GLYCERIN; PROPYLENE GLYCOL .3; 1 g/100mL; mL/100mL 11673-456_2f1edeae-8420-4b82-abb9-caf83e2a2d6e 11673-456 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20090701 ANDA ANDA076777 Target Corporation NICOTINE 2 mg/1 11673-458_4d209618-f703-4110-bfb9-b6174fd559e8 11673-458 HUMAN OTC DRUG Up and Up All Day Allergy Relief Cetirizine Hydrochloride TABLET ORAL 20090527 ANDA ANDA078336 Target Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 11673-459_12a00133-8a4c-4059-8b21-a0b0dae21a21 11673-459 HUMAN OTC DRUG up and up cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110922 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 11673-461_c6347c86-9ce1-46ca-9631-7ef9c0ae8913 11673-461 HUMAN OTC DRUG Up and Up Ibuprofen Junior Ibuprofen TABLET, CHEWABLE ORAL 20130304 ANDA ANDA076359 Target Corporation IBUPROFEN 100 mg/1 11673-462_7c362aef-562d-4d7b-8d93-78d8714eb1d3 11673-462 HUMAN OTC DRUG up and up allergy relief diphenhydramine hydrochloride CAPSULE ORAL 20090610 OTC MONOGRAPH FINAL part341 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 11673-467_a7583fd4-3166-439b-aa39-917cd64f73ff 11673-467 HUMAN OTC DRUG Up and Up Aspirin Aspirin TABLET, CHEWABLE ORAL 20090624 OTC MONOGRAPH NOT FINAL part343 Target Corporation ASPIRIN 81 mg/1 11673-470_a6b9fd34-8967-45c0-8c45-5ce2738c9384 11673-470 HUMAN OTC DRUG Daytime Multi-Symptom Cold Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050715 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 11673-471_abeb8463-92f7-4d51-a2be-7fda12136477 11673-471 HUMAN OTC DRUG Up and Up anti itch maximum strength hydrocortisone OINTMENT TOPICAL 20091009 OTC MONOGRAPH NOT FINAL part348 Target Corporation HYDROCORTISONE 1 g/100g 11673-479_efcffe91-f583-4b1b-ab94-cbd5f04e20b4 11673-479 HUMAN OTC DRUG ANTACID extra strength calcium carbonate TABLET, CHEWABLE ORAL 20100215 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 750 mg/1 11673-480_efcffe91-f583-4b1b-ab94-cbd5f04e20b4 11673-480 HUMAN OTC DRUG ANTACID extra strength calcium carbonate TABLET, CHEWABLE ORAL 20100215 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 750 mg/1 11673-481_22cf99e5-6844-4971-aa41-5cb3cac88e5c 11673-481 HUMAN OTC DRUG ANTACID calcium carbonate TABLET ORAL 20100215 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 1000 mg/1 11673-484_70ffe3bc-4d45-47ff-b975-c6c58b7a2a89 11673-484 HUMAN OTC DRUG up and up acetaminophen extra strength Acetaminophen TABLET ORAL 20091202 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 500 mg/1 11673-486_ce185c79-2c41-429b-af40-856be0e0bda2 11673-486 HUMAN OTC DRUG Up and up stool softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20090708 OTC MONOGRAPH NOT FINAL part334 Target Corporation DOCUSATE SODIUM 100 mg/1 11673-490_d6dc23d5-2abd-4067-9ffd-b4476ce93618 11673-490 HUMAN OTC DRUG Up and Up Naproxen sodium Naproxen Sodium TABLET ORAL 20090714 ANDA ANDA074661 Target Corporation NAPROXEN SODIUM 220 mg/1 11673-497_13c184ab-ef49-42b6-ba22-614a26abb20b 11673-497 HUMAN OTC DRUG Up and Up Jock Itch Relief Miconazole Nitrate SPRAY TOPICAL 20130925 OTC MONOGRAPH FINAL part333C Target Corporation MICONAZOLE NITRATE 2 g/100g 11673-498_7240cc18-c8d0-48d7-925a-56bfd2a55691 11673-498 HUMAN OTC DRUG Up and Up Mucus Relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130515 ANDA ANDA078912 Target Corporation GUAIFENESIN 600 mg/1 11673-502_ce93ca5b-2a65-4873-9686-926c44076c6c 11673-502 HUMAN OTC DRUG Up and Up Allergy Relief Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20141217 ANDA ANDA078336 Target Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 11673-503_1b7b83c3-5856-4f29-bf03-3415f33d072c 11673-503 HUMAN OTC DRUG Severe Cold Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Guaifenesin TABLET, FILM COATED ORAL 20060622 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 11673-504_f53d5418-5878-4c86-a2bb-b0ff61aec768 11673-504 HUMAN OTC DRUG Up and Up Jock Itch Relief Clotrimazole CREAM TOPICAL 20130917 OTC MONOGRAPH FINAL part333C Target Corporation CLOTRIMAZOLE 1 g/100g 11673-510_d672ad3e-7d1c-44a5-859e-be47e51527ca 11673-510 HUMAN OTC DRUG Maximum Strength Medicated Foot Powder Medicated Foot Powder POWDER TOPICAL 20130430 OTC MONOGRAPH NOT FINAL part348 Target Corporation MENTHOL .1 g/g 11673-513_710cd931-0ca1-45b3-a430-14237c2365f4 11673-513 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Target Corporation LORATADINE 10 mg/1 11673-516_e18f2c77-d2f9-42fd-8637-df7f3d423aa1 11673-516 HUMAN OTC DRUG up and up adult cough and cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20090612 OTC MONOGRAPH FINAL part341 Target Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 11673-517_eaf9a012-378f-440a-9b53-0bb22e83428f 11673-517 HUMAN OTC DRUG up and up ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA077349 Target Corporation IBUPROFEN 200 mg/1 11673-519_980f96e5-e4f5-40cf-bd0b-d98d1b9d7f62 11673-519 HUMAN OTC DRUG Rapid Release Pain Reliever Acetaminophen CAPSULE, LIQUID FILLED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 500 mg/1 11673-520_98dd14f0-d1a4-4992-9be8-e5da60d170d9 11673-520 HUMAN OTC DRUG Loperamide HCl LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20111001 NDA NDA021855 TARGET Corporation LOPERAMIDE HYDROCHLORIDE 2 mg/1 11673-521_6acd5878-35b6-452a-b00b-a69467a7c8f2 11673-521 HUMAN OTC DRUG up and up junior strength ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20100622 ANDA ANDA076359 Target Corporation IBUPROFEN 100 mg/1 11673-527_710cd931-0ca1-45b3-a430-14237c2365f4 11673-527 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Target Corporation LORATADINE 10 mg/1 11673-529_13e6aa31-25d2-47de-8c29-c66a6530cbdb 11673-529 HUMAN OTC DRUG Multi-Symptom Cold Relief Acetaminophen, Chlorpehniramine HCl, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 Target Corporation 11673-532_6ee33789-fa64-4f8f-9c40-cf993916fa07 11673-532 HUMAN OTC DRUG Up and Up nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20090709 ANDA ANDA076779 Target Corporation NICOTINE 4 mg/1 11673-536_d8f45d2b-165d-42a8-9662-055b4aef76c6 11673-536 HUMAN OTC DRUG Up and Up Bacitracin first aid Bacitracin OINTMENT TOPICAL 20091129 OTC MONOGRAPH FINAL part333B Target Corporation BACITRACIN 500 [USP'U]/g 11673-544_f53ee1bf-1ba1-4962-8196-5584ae36e746 11673-544 HUMAN OTC DRUG up and up temporary minor arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090623 ANDA ANDA075077 Target Corporation ACETAMINOPHEN 650 mg/1 11673-545_4d33b0aa-e11a-4a93-88db-b525e0bc8025 11673-545 HUMAN OTC DRUG Instant hand Sanitizer ALCOHOL GEL TOPICAL 20090109 OTC MONOGRAPH NOT FINAL part333A Target Corp. ALCOHOL .62 kg/100L 11673-546_c76067ef-6b43-48ae-a644-c787cca8380c 11673-546 HUMAN OTC DRUG up and up acid controller complete dual action Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20090731 ANDA ANDA077355 Target Corporation CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 11673-550_774ba2c8-3a9f-405c-b92b-b7aacccf11c5 11673-550 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20130830 OTC MONOGRAPH FINAL part347 Target Corporation DIMETHICONE 125 mg/1 11673-551_73149505-a2aa-4f13-bdce-65a4299b5303 11673-551 HUMAN OTC DRUG Medicated menthol, zinc oxide POWDER TOPICAL 20030730 OTC MONOGRAPH NOT FINAL part348 Target Corporation MENTHOL; ZINC OXIDE 1.5; 10 mg/g; mg/g 11673-556_c7c75fcd-e981-45ca-a00f-e99035d5d348 11673-556 HUMAN OTC DRUG Acetaminophen PM Acetaminophen and Diphenhydramine HCl CAPSULE ORAL 20071217 OTC MONOGRAPH NOT FINAL part341 Target Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 11673-560_189a8c5c-1732-4902-8a59-0dc9005f7165 11673-560 HUMAN OTC DRUG Multi-Symptom Daytime Cold Acetaminophen, Phenylephrine HCl and Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20080329 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 11673-563_cef4af25-1d88-4ada-abca-7f9190769136 11673-563 HUMAN OTC DRUG Low-Dose Aspirin Aspirin TABLET ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 Target Corporation ASPIRIN 81 mg/1 11673-571_2bae730c-b667-4555-86e8-9bf02d45a72f 11673-571 HUMAN OTC DRUG up and up allergy relief fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110413 ANDA ANDA076447 Target Corporation FEXOFENADINE HYDROCHLORIDE 180 mg/1 11673-572_dc36f647-2d3c-442b-b16d-7c0ac65414c6 11673-572 HUMAN OTC DRUG glycerin, phenylephrine hydrochloride, pramoxine, white petrolatum glycerin, phenylephrine hydrochloride, pramoxine, white petrolatum CREAM RECTAL; TOPICAL 20090401 OTC MONOGRAPH FINAL part346 Target Corporation GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE .144; .15; .0025; .01 mg/g; mg/g; mg/g; mg/g 11673-580_406e7004-9978-426d-8c73-02c2bc167c89 11673-580 HUMAN OTC DRUG Up and Up Cold Flu Relief Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140730 OTC MONOGRAPH FINAL part341 Target Corporation 11673-583_fb234c9d-dfe3-476f-ae61-2205eb3489d2 11673-583 HUMAN OTC DRUG allergy and cold relief Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl CAPSULE ORAL 20090710 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 11673-585_a0531919-ea5f-446e-ac5a-9d5ab2230d8d 11673-585 HUMAN OTC DRUG Cinnamon Sugar Ethyl Alcohol GEL TOPICAL 20121213 OTC MONOGRAPH NOT FINAL part333A Target Corp., ALCOHOL 558 mg/mL 11673-586_d4963168-04ce-4c7a-ae01-db9f64abcd22 11673-586 HUMAN OTC DRUG Tolnaftate Antifungal Powder Spray with Baking Soda AEROSOL, POWDER TOPICAL 20081231 OTC MONOGRAPH FINAL part333C Target Corporation TOLNAFTATE 1.1 g/113.3g 11673-590_7c31d1ea-345b-4726-b124-d9a266778254 11673-590 HUMAN OTC DRUG up and up dye free infants pain and fever acetaminophen acetaminophen LIQUID ORAL 20111102 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 160 mg/5mL 11673-599_c60eaeba-f586-4d2c-809e-58badc325c64 11673-599 HUMAN OTC DRUG Childrens Allergy Relief Diphenhydramine HCl TABLET, ORALLY DISINTEGRATING ORAL 20110501 OTC MONOGRAPH FINAL part341 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 11673-600_112e2e0e-b96b-4753-8df1-800b0e3ca23f 11673-600 HUMAN OTC DRUG Alcohol Prep Pad isopropyl alcohol SWAB TOPICAL 20080701 OTC MONOGRAPH NOT FINAL part333E Target Corporation ISOPROPYL ALCOHOL .7 mL/1 11673-602_64229666-4a95-4e08-a05b-7618b099e53a 11673-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 19961212 OTC MONOGRAPH FINAL part334 Target Corporation MAGNESIUM SULFATE 1 g/g 11673-604_b397195a-5f16-4569-ba60-1ea4f7f66c6b 11673-604 HUMAN OTC DRUG up and up ibuprofen Ibuprofen TABLET ORAL 20090528 ANDA ANDA072096 Target Corporation IBUPROFEN 200 mg/1 11673-608_45f9ea8c-a110-4856-a9a4-47192fcf9b68 11673-608 HUMAN OTC DRUG Up and Up Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090623 ANDA ANDA075077 Target Corporation ACETAMINOPHEN 650 mg/1 11673-612_d05cbb2e-f830-4cab-9d36-01720f11f894 11673-612 HUMAN OTC DRUG up and up allergy relief Loratadine TABLET ORAL 20120326 ANDA ANDA076301 Target Corporation LORATADINE 10 mg/1 11673-615_d3f70259-bb23-4a13-a7b3-5487f4563958 11673-615 HUMAN OTC DRUG Sinus Congestion Relief extra strength Acetaminophen, Guaifenesin, Phenylephrine TABLET ORAL 20130407 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 11673-616_25af543f-c8dd-4e07-b677-517848e2814a 11673-616 HUMAN OTC DRUG up and up cold and flu relief multi symptom day and night combo pack Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20121011 OTC MONOGRAPH FINAL part341 Target Corporation 11673-622_645efb9e-8c4d-4d99-b43f-bc38761ee87b 11673-622 HUMAN OTC DRUG Up and Up itch relief Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part348 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 11673-641_837481f5-7454-4d63-9750-d978b021b555 11673-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part333A Target Corporation BENZALKONIUM CHLORIDE .999 mg/mL 11673-645_0ccead2a-50ff-4317-81fa-f699f95fdc44 11673-645 HUMAN OTC DRUG PE multi-stymptom cold and cough relief Acetaminophen, Dextromathorphan HBr, Gauifenesin, Phenylephrine HCl CAPSULE, COATED ORAL 20070222 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 11673-647_4bb1f271-3f6b-4e2d-ae0d-1ff9d4a17aaa 11673-647 HUMAN OTC DRUG up and up ibuprofen Ibuprofen TABLET ORAL 20090528 ANDA ANDA072096 Target Corporation IBUPROFEN 200 mg/1 11673-656_be59e1bb-7448-481c-841d-d2d77e2eca7c 11673-656 HUMAN OTC DRUG Up and Up Cold Flu Relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20090707 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 11673-657_96b15aea-a460-4999-87ca-cc6fbaa23ab2 11673-657 HUMAN OTC DRUG NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING ORAL 20100215 NDA NDA018612 Target Corporation NICOTINE 2 mg/1 11673-658_96b15aea-a460-4999-87ca-cc6fbaa23ab2 11673-658 HUMAN OTC DRUG NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING ORAL 20100215 NDA NDA020066 Target Corporation NICOTINE 4 mg/1 11673-660_98d200b1-dd53-43e6-991c-6cfe08aa6b41 11673-660 HUMAN OTC DRUG up and up childrens ibuprofen Ibuprofen SUSPENSION ORAL 20090708 ANDA ANDA074937 Target Corporation IBUPROFEN 100 mg/5mL 11673-663_cddcd70f-b86f-4d74-82bf-682d3aca0351 11673-663 HUMAN OTC DRUG Crisp Apple Hand Sani Ethyl Alcohol LIQUID TOPICAL 20141005 OTC MONOGRAPH NOT FINAL part333A Target Corporation ALCOHOL 585 g/mL 11673-664_75452df0-2b33-455e-aa03-cb01211f1c26 11673-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19930811 OTC MONOGRAPH NOT FINAL part356 Target Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 11673-667_8dfa99a0-32ad-400d-abd9-1e3b26eddf12 11673-667 HUMAN OTC DRUG up and up cough suppressant and topical analgesic chest rub Camphor, Eucalyptus oil, Menthol natural OINTMENT TOPICAL 20090127 OTC MONOGRAPH FINAL part341 Target Corporation CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 48; 12; 26 mg/g; mg/g; mg/g 11673-675_8ddeac78-ce53-49a4-979b-ca8403c15b11 11673-675 HUMAN OTC DRUG Medicated Pads witch hazel SOLUTION TOPICAL 20071001 OTC MONOGRAPH FINAL part346 Target Corporation WITCH HAZEL .5 mL/mL 11673-679_2c389ffd-ef4c-4eaf-801c-565a45848ec6 11673-679 HUMAN OTC DRUG Up and Up First Aid Antibiotic Pain Relieving Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20091117 OTC MONOGRAPH FINAL part333B Target Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 11673-685_bff6c821-fc9e-4774-9833-3792aacfdd2e 11673-685 HUMAN OTC DRUG up and up ibuprofen Ibuprofen LIQUID ORAL 20090710 ANDA ANDA074937 Target Corporation IBUPROFEN 100 mg/5mL 11673-690_0534134f-8baa-430c-bdd1-9b83cbc81703 11673-690 HUMAN OTC DRUG up and up allergy relief Diphenhydramine Hydrochloride TABLET ORAL 20090612 OTC MONOGRAPH FINAL part341 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 11673-705_15069389-9113-4ddd-92d0-fa6d667402cf 11673-705 HUMAN OTC DRUG up and up allergy relief cetirizine Hydrochloride SOLUTION ORAL 20141223 ANDA ANDA090254 Target Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL 11673-722_22cf99e5-6844-4971-aa41-5cb3cac88e5c 11673-722 HUMAN OTC DRUG ANTACID calcium carbonate TABLET ORAL 20130308 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 1000 mg/1 11673-726_efcffe91-f583-4b1b-ab94-cbd5f04e20b4 11673-726 HUMAN OTC DRUG ANTACID extra strength calcium carbonate TABLET, CHEWABLE ORAL 20140310 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 750 mg/1 11673-733_0d8a9f95-982e-4a00-9dc0-49147da27276 11673-733 HUMAN OTC DRUG Up and Up Cold Flu Relief Day Night Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20140818 OTC MONOGRAPH FINAL part341 Target Corporation 11673-734_0e2332f8-05c8-4473-ba4a-896d6f12ba66 11673-734 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex LOZENGE ORAL 20130313 ANDA ANDA203690 Target Corporation NICOTINE 2 mg/1 11673-742_66ce0399-ba03-42bc-9fac-d10df2962335 11673-742 HUMAN OTC DRUG Up and Up Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20110105 NDA NDA021920 Target Corporation NAPROXEN SODIUM 220 mg/1 11673-751_d31fec9a-63f8-4798-aa43-ee741c5eaad5 11673-751 HUMAN OTC DRUG up and up acetaminophen pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120224 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 11673-759_9d9f210c-599b-4af4-9919-84f815e7230b 11673-759 HUMAN OTC DRUG up and up childrens acetaminophen Acetaminophen SUSPENSION ORAL 20110716 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 160 mg/5mL 11673-766_156ee567-3b8b-4a2f-b041-b28315e90db0 11673-766 HUMAN OTC DRUG up and up dye free infants pain and fever acetaminophen Acetaminophen LIQUID ORAL 20111102 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 160 mg/5mL 11673-787_81bf1b98-cf2c-4ae4-a9d8-bec658d427bf 11673-787 HUMAN OTC DRUG Tension Headache Relief Acetaminophen, Caffeine CAPSULE, GELATIN COATED ORAL 20090209 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 11673-799_3e87d5be-2fc7-4bf7-9b15-d8ac66101140 11673-799 HUMAN OTC DRUG up and up adult cough formula dm max Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20100728 OTC MONOGRAPH FINAL part341 Target Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 11673-801_5cd5fd09-ae22-434c-a175-2b2e87b7ccf0 11673-801 HUMAN OTC DRUG Antibacterial Body Wash Moisturizing Triclosan SOAP TOPICAL 20100922 OTC MONOGRAPH NOT FINAL part333E Target Corporation TRICLOSAN .15 mL/100mL 11673-803_82108baf-ce6f-477e-9a35-56f83af1ea64 11673-803 HUMAN OTC DRUG Up and Up Mucus Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140730 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 11673-804_3d2a6a40-fdd4-4bd0-98b9-c0f4a54c47fc 11673-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19961212 OTC MONOGRAPH NOT FINAL part333A Target Corp ISOPROPYL ALCOHOL .91 mg/mL 11673-807_bd251c3a-0f54-4ebf-a006-287e9c9f7440 11673-807 HUMAN OTC DRUG Up and Up Zinc Cold Remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20090612 UNAPPROVED HOMEOPATHIC Target Corporation ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 11673-808_a5521bcd-bbdf-47c4-a125-fede13583432 11673-808 HUMAN OTC DRUG Foaming Hand Wash Triclosan 0.46% LIQUID TOPICAL 20120806 OTC MONOGRAPH NOT FINAL part333A Target Corp TRICLOSAN .46 mg/mL 11673-809_6d8cc502-22ba-4520-8fcb-2ae21a77413a 11673-809 HUMAN OTC DRUG Up and Up alcohol Isopropyl Alcohol SWAB TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Target Corporation ISOPROPYL ALCOHOL 70 mL/100mL 11673-811_5e755d65-d36f-4609-9103-45d0c1dbd43b 11673-811 HUMAN OTC DRUG Kids Foaming Hand Sanitizer Alcohol Free Benzalkonium chloride LIQUID TOPICAL 20120413 OTC MONOGRAPH NOT FINAL part333A Target Brands BENZALKONIUM CHLORIDE .13 g/mL 11673-812_5e952aa5-76fb-421b-a5dc-5aa2a4b93fe6 11673-812 HUMAN OTC DRUG Kids Foaming Hand Sanitizer Alcohol Free Benzalkonium chloride LIQUID TOPICAL 20120413 OTC MONOGRAPH NOT FINAL part333A Target Brands BENZALKONIUM CHLORIDE .13 g/mL 11673-815_d7b15d1f-c21c-4eaa-a2a9-56abe37fd5c2 11673-815 HUMAN OTC DRUG UP AND UP MOISTURIZING BODY WASH BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140305 OTC MONOGRAPH NOT FINAL part333E TARGET CORPORATION BENZALKONIUM CHLORIDE 1.3 mg/mL 11673-816_dd0587aa-0ba6-4228-b544-f9c1c57c5bd2 11673-816 HUMAN OTC DRUG UP AND UP MOISTURIZING ANTIBACTERIAL BODY WASH BENZALKONIUM CHLORIDE LIQUID TOPICAL 20141221 OTC MONOGRAPH NOT FINAL part333E TARGET CORPORATION BENZALKONIUM CHLORIDE 1.3 mg/mL 11673-818_16bfb893-24a4-4087-a077-04a3ecb1d213 11673-818 HUMAN OTC DRUG up and up cold and hot medicated menthol PATCH TOPICAL 20080410 OTC MONOGRAPH NOT FINAL part348 Target Corporation MENTHOL 50 mg/1 11673-822_ff4c6436-36a0-46b6-81c7-95bb205ecfd3 11673-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 19980129 OTC MONOGRAPH FINAL part347 Target Corporation WITCH HAZEL 86 kg/100L 11673-825_1b1e7a9a-b748-413a-9a9f-585a3b65a857 11673-825 HUMAN OTC DRUG up and up miconazole 7 Miconazole nitrate CREAM VAGINAL 20090826 ANDA ANDA074760 Target Corporation MICONAZOLE NITRATE 2 g/100g 11673-831_1993dd06-47ae-4226-b534-efc04c21ed2f 11673-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 19961212 OTC MONOGRAPH NOT FINAL part334 Target Corp MINERAL OIL 999 mg/mL 11673-836_a7d0fd71-6ed0-4fc5-8025-2035a762646c 11673-836 HUMAN OTC DRUG 2 in 1 Pyrithione zinc SHAMPOO TOPICAL 20130506 OTC MONOGRAPH FINAL part358H Target Corporation PYRITHIONE ZINC 10.3 mg/mL 11673-845_912adfda-205d-4d80-a337-5ee689e303e0 11673-845 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20070314 OTC MONOGRAPH FINAL part344 Target Corporation ISOPROPYL ALCOHOL 613 mg/mL 11673-852_a829b5ad-9478-4514-8e92-f6047d98c7e4 11673-852 HUMAN OTC DRUG Up and Up Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130911 ANDA ANDA091429 Target Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 11673-854_feae673f-d9cc-415a-89c2-d31e2cd5cbda 11673-854 HUMAN OTC DRUG Up and Up Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20110216 ANDA ANDA078546 Target Corporation NICOTINE 4 mg/1 11673-855_bbb0b888-b5cc-46e6-83c6-0f0d830673fd 11673-855 HUMAN OTC DRUG Childrens Allergy Melts Diphenhydramine HCl TABLET, ORALLY DISINTEGRATING ORAL 20090320 OTC MONOGRAPH FINAL part341 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 11673-856_6ade6331-f2df-4edc-9e56-f756998cbe9d 11673-856 HUMAN OTC DRUG Up and Up minoxidil Minoxidil SOLUTION TOPICAL 20090527 ANDA ANDA075357 Target Corporation MINOXIDIL 2 g/100mL 11673-866_e8a2025f-3677-4a6d-bb3c-8edc89c87e88 11673-866 HUMAN OTC DRUG Up and up lice killing maximum strength Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20090822 OTC MONOGRAPH FINAL part358G Target Corporation PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL 11673-871_99e2246d-2594-49f9-a30d-81882f477f4e 11673-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Target Corp HYDROGEN PEROXIDE .3 kg/100L 11673-873_e56fe11d-8841-447c-82ef-29b183f75f2a 11673-873 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex LOZENGE ORAL 20090701 ANDA ANDA077007 Target Corporation NICOTINE 4 mg/1 11673-878_6126c47a-0d33-4a86-ba38-9ce48e750ed6 11673-878 HUMAN OTC DRUG Up and Up Anti Itch Hydrocortisone LOTION TOPICAL 20130612 OTC MONOGRAPH NOT FINAL part348 Target Corporation HYDROCORTISONE 1 g/100g 11673-882_e91ebfbd-25b6-457b-93e5-67bab316141e 11673-882 HUMAN OTC DRUG Up and Up Infants Gas Relief Simethicone EMULSION ORAL 20090721 OTC MONOGRAPH FINAL part332 Target Corporation DIMETHICONE 20 mg/.3mL 11673-884_dee1b4bd-691b-421f-919a-91bb5dc2e05e 11673-884 HUMAN OTC DRUG Up and Up childrens all day allergy relief cetirizine Hydrochloride LIQUID ORAL 20110118 ANDA ANDA090254 Target Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL 11673-891_6f60daca-cd8d-4f02-b145-487324d19530 11673-891 HUMAN OTC DRUG up and up first aid antibiotic pain relieving Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20091117 OTC MONOGRAPH FINAL part333B Target Corporation NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP&apos'U]/g; mg/g 11673-897_f704fa60-f75d-47dc-90a2-f8d46cefdcbf 11673-897 HUMAN OTC DRUG up and up childrens ibuprofen Ibuprofen SUSPENSION ORAL 20090612 ANDA ANDA074937 Target Corporation IBUPROFEN 100 mg/5mL 11673-903_2a49daa7-f0f2-4abc-8778-04d9656a18be 11673-903 HUMAN OTC DRUG up and up childrens multi symptom cold pain relief plus Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20090626 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 11673-908_26d6e0cb-2dab-4b05-a189-259c22f0c25b 11673-908 HUMAN OTC DRUG Up and Up Cold Flu Relief multi symptom night acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20090611 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 11673-910_619916d0-7d1c-4957-805a-00c482c71ada 11673-910 HUMAN OTC DRUG UpandUp Clotrimazole Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Target Corporation CLOTRIMAZOLE 10 mg/g 11673-911_eae54fe5-de91-474d-b3ac-4a023660b7f4 11673-911 HUMAN OTC DRUG up and up childrens ibuprofen oral suspension Ibuprofen SUSPENSION ORAL 20090708 ANDA ANDA074937 Target Corporation IBUPROFEN 100 mg/5mL 11673-912_c4d74d3c-296c-4c93-a40c-5d3ea478225a 11673-912 HUMAN OTC DRUG Target antifungal Tolnaftate CREAM TOPICAL 20060217 OTC MONOGRAPH FINAL part333C Target Corporation TOLNAFTATE 10 mg/g 11673-913_e7242fda-59d6-4abf-b1ec-0d91549a613e 11673-913 HUMAN OTC DRUG up and up childrens cold and cough relief Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20100716 OTC MONOGRAPH FINAL part341 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 11673-914_e630c2f5-b0ee-410a-91d2-5d321c925c30 11673-914 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Target Corporation LORATADINE 5 mg/5mL 11673-915_75e5e58a-331e-4f54-8feb-4c6c33998f45 11673-915 HUMAN OTC DRUG up and up omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20090714 NDA NDA022032 Target Corporation OMEPRAZOLE 20 mg/1 11673-916_2b1bc4dd-172c-49fb-8659-5c906e5d617f 11673-916 HUMAN OTC DRUG up and up miconazole 1 Miconazole nitrate KIT 20100903 ANDA ANDA079114 Target Corporation 11673-917_db633b78-88a6-498a-ab85-a810d6ee76b2 11673-917 HUMAN OTC DRUG up and up acetaminophen Acetaminophen CAPSULE, COATED ORAL 20110718 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 500 mg/1 11673-922_4d4981f6-beb5-43f8-b291-c5f7ee5a26ab 11673-922 HUMAN OTC DRUG Up and Up Mucus Relief Severe Congestion and Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130624 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 11673-923_267a5193-826e-4cde-8baa-97c56ea61570 11673-923 HUMAN OTC DRUG up and up eye itch relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20100903 ANDA ANDA077958 Target Corporation KETOTIFEN FUMARATE .25 mg/mL 11673-944_c2378e1f-2078-4a54-9ed7-57b862d7478c 11673-944 HUMAN OTC DRUG Up and Up Hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20140604 OTC MONOGRAPH FINAL part346 Target Corporation GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g 11673-951_7c71898c-a757-46eb-92ba-404396dbb3cd 11673-951 HUMAN OTC DRUG Instant Hand sanitizer ALCOHOL GEL TOPICAL 20110513 OTC MONOGRAPH NOT FINAL part333A Target ALCOHOL 65 kg/100L 11673-952_9c73f25c-1e5e-42c4-b38b-438667173082 11673-952 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 Target Corporation MENTHOL 1.5 mg/g 11673-954_9e9627b6-e4b1-44d9-859d-d22119cd3da9 11673-954 HUMAN OTC DRUG Fresh Citrus TRICLOSAN SOAP TOPICAL 20090512 OTC MONOGRAPH NOT FINAL part333A Target Corp. TRICLOSAN .115 kg/100L 11673-957_5abbe609-a78d-4bd2-831a-7447fa8c9c73 11673-957 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex LOZENGE ORAL 20130313 ANDA ANDA203690 Target Corporation NICOTINE 4 mg/1 11673-958_bf1af529-a801-416c-a9b8-4d95b4a08210 11673-958 HUMAN OTC DRUG Up and Up Cough Suppressant DM dextromethorphan polistirex SUSPENSION ORAL 20130617 ANDA ANDA091135 Target Corporation DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 11673-962_b2d79e3a-b0e3-4573-8269-fa595cb26a2f 11673-962 HUMAN OTC DRUG Foaming Hand Wash Triclosan 0.46% LIQUID TOPICAL 20120210 OTC MONOGRAPH NOT FINAL part333A Target Corp TRICLOSAN .46 mg/mL 11673-963_980fe302-c225-43a0-aab1-4ff8a150f29f 11673-963 HUMAN OTC DRUG Menstrual Pain Relief Multi-Symptom Acetaminophen, Pamabrom and Pyrilamine maleate TABLET, FILM COATED ORAL 20000620 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 11673-964_7a09a09c-c5b1-4856-b1b6-b2c6824675f9 11673-964 HUMAN OTC DRUG up and up flu and severe cold and cough relief Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20100902 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 11673-973_870163c5-ed24-4c39-a16c-c0caffc3897a 11673-973 HUMAN OTC DRUG Up and Up Anti Itch hydrocortisone CREAM TOPICAL 20130318 OTC MONOGRAPH NOT FINAL part348 Target Corporation HYDROCORTISONE 1 g/100g 11673-974_8f1a5f84-f2be-4075-b191-a68c414e1a5c 11673-974 HUMAN OTC DRUG Up and Up Childrens all day allergy relief cetirizine hydrochloride LIQUID ORAL 20090612 ANDA ANDA090254 Target Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL 11673-977_6c2f4e71-96c8-4b9c-a100-7b84f17cb0fa 11673-977 HUMAN OTC DRUG up and up cold and flu relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20090710 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 11673-980_780be1d9-030e-4dff-a2b8-2e5157d5ee62 11673-980 HUMAN OTC DRUG up and up dye free infants acetaminophen Acetaminophen SUSPENSION/ DROPS ORAL 20100609 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 80 mg/.8mL 11673-982_9a186532-ee69-428e-98a9-8ee69f4d667a 11673-982 HUMAN OTC DRUG Up and Up Miconazole 3 Miconazole nitrate KIT 20090812 ANDA ANDA076357 Target Corporation 11673-987_76239d67-0c52-4d63-a9c5-f3fcc005f0f8 11673-987 HUMAN OTC DRUG up and up childrens cold and cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20100721 OTC MONOGRAPH FINAL part341 Target Corporation BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 11673-994_de51eae1-d786-4d50-abe2-661b06b63c8d 11673-994 HUMAN OTC DRUG up and up cold flu relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20090710 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 11695-1403_bf900a90-9ece-4bbb-9a72-6f7e5c04e202 11695-1403 HUMAN PRESCRIPTION DRUG NEO-POLY-DEX Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19950913 ANDA ANDA064135 Butler Animal Health Supply DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 11695-1405_38ea57fe-ecfd-43d7-b992-0941cfb3f795 11695-1405 HUMAN PRESCRIPTION DRUG NEO-POLY-BAC Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 19951030 ANDA ANDA064064 Butler Animal Health Supply BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 10000 [USP'U]/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] 11695-1406_6541631a-6c77-44fc-b6ac-3b91e42e3065 11695-1406 HUMAN PRESCRIPTION DRUG NEO-POLY-BAC HYDRO Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone OINTMENT OPHTHALMIC 19951030 ANDA ANDA064068 Butler Animal Health Supply BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 10; 3.5; 10000 [USP'U]/g; mg/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 11695-1411_0de5bcce-0cc2-4b49-bd0d-714f1c7ec3bf 11695-1411 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC 19960726 ANDA ANDA040069 Butler Animal Health Supply DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 11695-1425_adf825a6-d141-4be3-9a9a-404bf907f796 11695-1425 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20100831 OTC MONOGRAPH FINAL part349 Butler Animal Health Supply WATER 99.05 mL/100mL 11695-1431_21092699-6ba7-42d2-b148-66a669084bc6 11695-1431 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS OPHTHALMIC 19940729 ANDA ANDA040070 Butler Animal Health Supply PREDNISOLONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 11695-1436_ca8900f2-cf16-425c-91f3-c41f8296358f 11695-1436 HUMAN PRESCRIPTION DRUG NEO-POLY-DEX Neomycin sulfate, Polymyxin B Sulfate, and Dexamethasone OINTMENT OPHTHALMIC 19940725 ANDA ANDA064063 Butler Animal Health Supply DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 11697-199_df6b35ae-36cd-4b2c-8a15-817c6eb970a8 11697-199 HUMAN OTC DRUG Aloe Sunscreen Homosalate LOTION TOPICAL 20110406 OTC MONOGRAPH NOT FINAL part352 Aloe Vera of America, Inc. AVOBENZONE; ENSULIZOLE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3.54; 3.54; 1.18; 5.9; 3.922 mL/118mL; mL/118mL; mL/118mL; mL/118mL; mL/118mL 11697-318_47e35750-9678-4cd2-af27-e00fcfd4d3e4 11697-318 HUMAN OTC DRUG Forever Hand Sanitizer Hand Sanitizer Alcohol GEL TOPICAL 20100816 OTC MONOGRAPH NOT FINAL part333E Aloe Vera of America, Inc. ALCOHOL 36.58 mL/59mL 11697-319_c763a840-7e8e-43ee-8941-d2bd4a6e6737 11697-319 HUMAN OTC DRUG Aloe Sunscreen Homosalate SPRAY TOPICAL 20100816 OTC MONOGRAPH NOT FINAL part352 Aloe Vera of America, Inc. AVOBENZONE; ENSULIZOLE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 5.34; 7.12; 17.8; 8.9; 4.9662 mL/178mL; mL/178mL; mL/178mL; mL/178mL; mL/178mL 11697-371_7b0aee80-cf83-4852-b531-3aba12fcc4b3 11697-371 HUMAN OTC DRUG Flawless by Sonya Aloe BB Creme Nude TITANIUM DIOXIDE CREAM TOPICAL 20140112 OTC MONOGRAPH NOT FINAL part352 Aloe Vera of America, Inc. TITANIUM DIOXIDE 3.15 g/45g 11697-373_40f0d8fc-d934-4156-8f49-7ec4e266c6b6 11697-373 HUMAN OTC DRUG Flawless by Sonya Aloe BB Creme Cocoa Titanium Dioxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Aloe Vera of America, Inc. TITANIUM DIOXIDE 1.35 g/45g 11697-462_6c629c19-639c-4c7f-a69f-e7fbbce5cee9 11697-462 HUMAN OTC DRUG Forever Sun Lips Sunscreen LIPSTICK TOPICAL 20140425 OTC MONOGRAPH NOT FINAL part352 Aloe Vera of America, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; PETROLATUM .1275; .425; .2125; .1186; 1.615 g/4.25g; g/4.25g; g/4.25g; g/4.25g; g/4.25g 11701-018_e1171fb6-2f8f-4a59-af89-255ccc19e56c 11701-018 HUMAN OTC DRUG Gentle Rain Antibacterial Triclosan SHAMPOO TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part333E Coloplast Manufacturing US, LLC TRICLOSAN 3 mL/1000mL 11701-020_0c76d9f5-4a95-47ec-92b3-9bff0100478c 11701-020 HUMAN OTC DRUG Bedside-Care Benzethonium chloride SHAMPOO TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part333E Coloplast Manufacturing US, LLC BENZETHONIUM CHLORIDE 1 mL/1000mL 11701-025_bae9cdd7-324e-4f1d-a447-e210b4edeaee 11701-025 HUMAN OTC DRUG Isagel B-I-B Alcohol GEL TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part333E Coloplast Manufacturing US, LLC ALCOHOL 600 mL/1000mL 11701-025_bdf126c0-de0e-4f0c-a495-6bba86a509df 11701-025 HUMAN OTC DRUG Isagel Alcohol GEL TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part333E Coloplast Manufacturing US, LLC ALCOHOL 600 mL/1000mL 11701-038_07fe298c-cb39-45d8-9544-4ac73e993f22 11701-038 HUMAN OTC DRUG Micro-Guard (AF) Miconazole Nitrate POWDER TOPICAL 20090615 OTC MONOGRAPH FINAL part333C Coloplast Manufacturing US, LLC MICONAZOLE NITRATE 20 mg/g 11701-045_b5fc1620-6fa7-4bbf-8f40-9e000c070236 11701-045 HUMAN OTC DRUG Baza Antifungal Miconazole nitrate CREAM TOPICAL 20090615 OTC MONOGRAPH FINAL part333C Coloplast Manufacturing US, LLC MICONAZOLE NITRATE 20 mg/g 11701-046_43ad527c-244f-47a7-994c-0378a00df14f 11701-046 HUMAN OTC DRUG Baza Protect Zinc oxide and Dimethicone CREAM TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part347 Coloplast Manufacturing US, LLC DIMETHICONE; ZINC OXIDE 10; 120 mg/g; mg/g 11701-047_2401e719-c14a-4821-ad45-646f86a8fb9f 11701-047 HUMAN OTC DRUG Baza Cleanse and Protect Dimethicone LOTION TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part347 Coloplast Manufacturing US, LLC DIMETHICONE 20 mg/g 11701-048_b8033d35-4a95-42d0-9c84-43d873aef9a4 11701-048 HUMAN OTC DRUG Baza Clear Petrolatum OINTMENT TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part347 Coloplast Manufacturing US, LLC PETROLATUM 960 mg/g 11701-050_fe37d81d-da4e-4d97-8dbf-28e51c811907 11701-050 HUMAN OTC DRUG Critic Aid Skin Zinc oxide PASTE TOPICAL 20090615 OTC MONOGRAPH FINAL part346 Coloplast Manufacturing US, LLC ZINC OXIDE 200 mg/g 11701-052_bdd5b868-8258-4f8d-8312-fdfb76fd9b31 11701-052 HUMAN OTC DRUG Bedside-Care Foam (Alcohol Free) Benzethonium chloride SHAMPOO TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part333E Coloplast Manufacturing US, LLC BENZETHONIUM CHLORIDE 100 mg/100mL 11701-053_20af33a0-4a04-4a6b-83f7-f8bd8edc0d99 11701-053 HUMAN OTC DRUG Bedside-Care Benzethonium chloride SHAMPOO TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part333E Coloplast Manufacturing US, LLC BENZETHONIUM CHLORIDE 100 mg/100mL 11701-059_af2cb1f8-f41b-470b-868c-edd654a970af 11701-059 HUMAN OTC DRUG Bedside-Care Perineal Wash Benzethonium chloride LIQUID TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part333E Coloplast Manufacturing US, LLC BENZETHONIUM CHLORIDE 1 mL/L 11701-062_58cfa69c-02e4-4e88-bfb2-7fc1ccc9f0b6 11701-062 HUMAN OTC DRUG Baza Cleanse and Protect Odor Control Dimethicone LOTION TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part347 Coloplast Manufacturing US, LLC DIMETHICONE 20 mg/g 11701-063_58a9248a-bd59-4bf5-9d80-a9b72f648bf2 11701-063 HUMAN OTC DRUG Sween 24 Dimethicone CREAM TOPICAL 20090615 OTC MONOGRAPH FINAL part347 Coloplast Manufacturing US, LLC DIMETHICONE 60 mg/g 11701-066_2659e763-1867-435c-b160-ba3001c034b8 11701-066 HUMAN OTC DRUG Critic Aid Clear Petrolatum OINTMENT TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part347 Coloplast Manufacturing US, LLC PETROLATUM 710 mg/g 11701-067_1b526080-40ba-48cf-92fe-216d12a9f224 11701-067 HUMAN OTC DRUG Critic Aid Clear AF Miconazole Nitrate OINTMENT TOPICAL 20090615 OTC MONOGRAPH FINAL part333C Coloplast Manufacturing US, LLC MICONAZOLE NITRATE 20 mg/g 11704-235_5b7a8e92-c85b-4906-8938-0d2311f9a06a 11704-235 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAMUSCULAR 19900712 NDA NDA019999 Meridian Medical Technologies, Inc. MORPHINE SULFATE 10 mg/.7mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 11704-270_d3ecf5b0-e14c-4e91-ac44-8e5991747132 11704-270 HUMAN PRESCRIPTION DRUG Cyanokit hydroxocobalamin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090831 NDA NDA022041 Meridian Medical Technologies, Inc. HYDROXOCOBALAMIN 2.5 g/100mL Antidote [EPC] 11704-370_429aae46-5eba-43a3-83e5-140afd09a530 11704-370 HUMAN PRESCRIPTION DRUG Cyanokit Hydroxocobalamin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20111001 NDA NDA022041 Meridian Medical Technologies, Inc. HYDROXOCOBALAMIN 5 g/250mL Antidote [EPC] 11704-620_fb1d494d-c536-4c70-a8ce-408eae47a23d 11704-620 HUMAN PRESCRIPTION DRUG DuoDote atropine and pralidoxime chloride KIT INTRAMUSCULAR 20060906 NDA NDA021983 Meridian Medical Technologies , Inc. 11716-0001_00637064-ea23-451f-be9b-73b1f5dcf896 11716-0001 HUMAN OTC DRUG GOODSENSE ARTIFICIAL TEARS POLYVINYL ALCOHOL SOLUTION OPHTHALMIC 20100722 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. POLYVINYL ALCOHOL; POVIDONE 5; 6 mg/mL; mg/mL 11716-0002_6bdd2b86-9fee-4d75-a7dd-3c43c65167d6 11716-0002 HUMAN OTC DRUG GOODSENSE ORIGINAL EYE DROPS TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20141126 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 11716-0003_f12b0cbb-b8cf-4ce5-aa80-acc950cee090 11716-0003 HUMAN OTC DRUG GOODSENSE IRRITATION RELIEF EYE TETRAHYDROZOLINE HYDROCHLORIDE, AND ZINC SULFATE SOLUTION/ DROPS OPHTHALMIC 20100802 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL 11716-0004_21ebdfe6-c527-460e-be39-95b9eb9dae78 11716-0004 HUMAN OTC DRUG GOODSENSE ADVANCED RELIEF EYE DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, AND TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION/ DROPS OPHTHALMIC 20100804 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL 11716-0041_90acc763-c7e6-4281-9e5c-04275289c1e9 11716-0041 HUMAN OTC DRUG GOODSENSE LUBRICATING EYE DROPS CARBOXYMETHYLCELLULOSE SODIUM SOLUTION OPHTHALMIC 20100730 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL 11716-0042_ab78481d-d571-42ab-a375-f4421c7f83cd 11716-0042 HUMAN OTC DRUG GOODSENSE LUBRICANT EYE DROPS POLYETHYLENE GLYCOL 400 SOLUTION OPHTHALMIC 20100804 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mL/mL; mL/mL 11716-0051_3d327878-155d-44c8-903b-c7d2ff227417 11716-0051 HUMAN OTC DRUG DG LUBRICANT EYE DROPS POLYETHYLENE GLYCOL 400 SOLUTION OPHTHALMIC 20100426 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mL/mL; mL/mL 11716-0053_67fddf3f-80e0-4fda-84fc-c0154c0c2d42 11716-0053 HUMAN OTC DRUG DG HEALTH ORIGINAL TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20100812 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 11716-0101_2383b6cc-a845-4599-b785-d35391f88cbf 11716-0101 HUMAN OTC DRUG PREMIER VALUE ORIGINAL TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20140519 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 11716-0102_a6cd1636-a269-460b-bfb2-d29fb2fb97f0 11716-0102 HUMAN OTC DRUG PREMIER VALUE ADVANCED EYE DROPS DEXTRAN 70 SOLUTION OPHTHALMIC 20100812 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .001; .01; .01; .0005 mL/mL; mL/mL; mL/mL; mL/mL 11716-0103_f02c0b6e-3369-43fe-b992-0ad9d84f2191 11716-0103 HUMAN OTC DRUG PREMIER VALUE EYE AC TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE SOLUTION OPHTHALMIC 20101102 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL 11716-0224_9ee77831-433d-425d-b3cc-f95773f53093 11716-0224 HUMAN OTC DRUG PREMIER VALUE EYE DROPS MT POLYVINYL ALCOHOL AND POVIDONE SOLUTION OPHTHALMIC 20101019 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. POLYVINYL ALCOHOL; POVIDONE 5; 6 mg/mL; mg/mL 11716-0458_cf47d75f-6acf-4e22-acd5-88c24d82754d 11716-0458 HUMAN OTC DRUG SHOPKO ADVANCED FORMULA EYE DROPS DEXTRAN 70 SOLUTION OPHTHALMIC 20100812 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .001; .01; .01; .0005 mL/mL; mL/mL; mL/mL; mL/mL 11716-0460_505ed84a-9943-43b3-9240-f47cb0a6ea3c 11716-0460 HUMAN OTC DRUG SHOPKO RELIEF TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE SOLUTION OPHTHALMIC 20101008 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL 11716-1104_ddd93887-104b-4d41-8cdb-bf19ef9154a1 11716-1104 HUMAN OTC DRUG LEADER ADVANCED FORMULA EYE DROPS DEXTRAN 70 SOLUTION OPHTHALMIC 20100506 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .001; .01; .01; .0005 mL/mL; mL/mL; mL/mL; mL/mL 11716-1163_2fd8e64f-8fa0-43d6-b48d-a1246b7e557a 11716-1163 HUMAN OTC DRUG LEADER EYE ITCH RELIEF DROPS KETOTIFEN FUMARATE SOLUTION/ DROPS OPHTHALMIC 20100421 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. KETOTIFEN FUMARATE .345 mg/mL 11716-1167_0fb24097-4d04-4fe4-ab58-da8b3c8cb57e 11716-1167 HUMAN OTC DRUG WALGREENS MAXIMUM RELIEF EYE DROPS DEXTRAN 70 SOLUTION OPHTHALMIC 20100526 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .001; .01; .01; .0005 mL/mL; mL/mL; mL/mL; mL/mL 11716-1168_b19af045-9365-4310-883d-8ae53c5866cb 11716-1168 HUMAN OTC DRUG WALGREENS ORIGINAL EYE DROPS TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20100526 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 11716-1187_cb039152-7e0b-498a-9d68-aabd9a8e4c59 11716-1187 HUMAN OTC DRUG FREDS ORIGINAL EYE DROPS TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20100514 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 11716-1188_f77c4ca9-319e-419e-a954-0e2ffa50bfe8 11716-1188 HUMAN OTC DRUG WALGREENS ARTIFICIAL TEARS EYE DROPS DEXTRAN 70 SOLUTION OPHTHALMIC 20100614 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. DEXTRAN 70; HYPROMELLOSE 2910 (4000 CPS) .001; .003 mL/mL; mL/mL 11716-1189_50ac5f55-488a-4125-988f-86197f43fc01 11716-1189 HUMAN OTC DRUG FREDS DRY EYE RELIEF GLYCERIN SOLUTION OPHTHALMIC 20101206 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 .002; .002; .01 mL/mL; mL/mL; mL/mL 11716-1191_9659dafe-c8e5-4bc9-89c7-a7c691cf29d0 11716-1191 HUMAN OTC DRUG LEADER LUBRICATING EYE DROPS CARBOXYMETHYLCELLULOSE SODIUM SOLUTION OPHTHALMIC 20100429 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL 11716-1192_8a2dd2b4-e592-41a3-995f-c70427015383 11716-1192 HUMAN OTC DRUG LEADER LUBRICANT EYE DROPS POLYETHYLENE GLYCOL 400 SOLUTION OPHTHALMIC 20100428 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mL/mL; mL/mL 11716-1609_5fa5becf-c2b7-48cc-a66d-e9f34683b542 11716-1609 HUMAN OTC DRUG SHOPKO ORIGINAL FORMULA EYE DROPS TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20100812 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 11716-1629_babce0c4-1715-4831-9a4b-21d0c307e278 11716-1629 HUMAN OTC DRUG SHOPKO DRY EYE RELIEF GLYCERIN SOLUTION OPHTHALMIC 20100812 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. GLYCERIN; HYPROMELLOSE; POLYETHYLENE GLYCOL 400 .002; .002; .01 mL/mL; mL/mL; mL/mL 11716-4060_5341e693-0555-4824-94ab-5e86345b231f 11716-4060 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY LUBRICANT EYE DROPS POLYETHYLENE GLYCOL 400 SOLUTION OPHTHALMIC 20100920 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mL/mL; mL/mL 11716-4708_312b0852-6077-491f-ae04-3a079d9bb885 11716-4708 HUMAN OTC DRUG LEADER ORIGINAL FORMULA EYE DROPS TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION/ DROPS OPHTHALMIC 20100322 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL CIV 11716-7900_104383c5-f46c-4c07-85cd-bf2486c1e6b3 11716-7900 HUMAN OTC DRUG MEIJER LUBRICANT EYE DROPS POLYETHYLENE GLYCOL 400 SOLUTION OPHTHALMIC 20100430 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mL/mL; mL/mL 11716-7901_0270c386-37e0-4359-8892-16b099e0bad3 11716-7901 HUMAN OTC DRUG MEIJER LUBRICATING EYE DROPS CARBOXYMETHYLCELLULOSE SODIUM SOLUTION OPHTHALMIC 20100513 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL 11716-8653_09954878-36dc-46ba-9e9b-9c73adc623e3 11716-8653 HUMAN OTC DRUG CARE ONE EYE DROPS SEASONAL RELIEF TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE SOLUTION OPHTHALMIC 20101102 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL 11716-9637_396900be-73f8-4ccf-ab2f-b188b8e80f5c 11716-9637 HUMAN OTC DRUG LEADER DRY EYE RELIEF DEXTRAN 70 SOLUTION OPHTHALMIC 20100712 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. DEXTRAN 70; HYPROMELLOSE 2910 (4000 CPS) .001; .003 mL/mL; mL/mL 11716-9638_7ccb006e-809f-4f34-9695-f4e93fc39f51 11716-9638 HUMAN OTC DRUG LEADER RELIEF TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE SOLUTION OPHTHALMIC 20101008 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL 11727-006_403e414a-92e2-42a6-9539-aa7a9460e89d 11727-006 HUMAN OTC DRUG X-PEL Anti-Lice Apis Mellifica, Carbolicum Acidum, Ledum Palustre SHAMPOO TOPICAL 20140415 UNAPPROVED HOMEOPATHIC Dermedics Laboratories APIS MELLIFERA; LEDUM PALUSTRE TWIG; PHENOL 15; 15; 15 [hp_X]/170g; [hp_X]/170g; [hp_X]/170g 11727-007_96a3db88-ce84-4a4b-b3d5-9151e7c16ca7 11727-007 HUMAN OTC DRUG X-PEL PURE Anti-Lice Apis Mellifica, Carbolicum Acidum, Ledum Palustre SHAMPOO TOPICAL 20140415 UNAPPROVED HOMEOPATHIC Dermedics Laboratories APIS MELLIFERA; LEDUM PALUSTRE TWIG; PHENOL 15; 15; 15 [hp_X]/170g; [hp_X]/170g; [hp_X]/170g 11748-010_c031e1df-ccf0-4e9f-a4fd-b0ec0d242136 11748-010 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19880101 UNAPPROVED MEDICAL GAS P and J Oxyfill, LLC OXYGEN 99 L/100L 11819-282_4db8da08-120b-4098-b938-202075869844 11819-282 HUMAN PRESCRIPTION DRUG Probenecid Probenecid TABLET, FILM COATED ORAL 19830701 ANDA ANDA084442 HHS/Program Support Center/Supply Service Center PROBENECID 500 mg/1 11819-305_99c94f94-7630-4942-9c78-ea6b740e5d2b 11819-305 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20110617 ANDA ANDA062505 HHS/Program Support Center/Supply Service Center DOXYCYCLINE HYCLATE 100 mg/1 11819-311_13c33778-3828-4a64-849a-5346cbeb264a 11819-311 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 HHS/Program Support Center/Supply Service Center DOXYCYCLINE HYCLATE 100 mg/1 11819-323_dc9e0bf6-012f-47c2-8b54-a4a7a2530ed2 11819-323 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 HHS/Program Support Center/Supply Service Center CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 11819-342_ac8d96ed-3661-4b62-b4e2-c42c93042cf3 11819-342 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20100618 NDA NDA021906 HHS/Program Support Center/Supply Service Center LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] 11819-348_668c81b3-613a-4f70-8f9c-1272ca77a6fa 11819-348 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20110617 ANDA ANDA062505 HHS/Program Support Center/Supply Service Center DOXYCYCLINE HYCLATE 100 mg/1 11819-351_29189c63-3b09-495d-bacc-d850da3a1a7e 11819-351 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 HHS/Program Support Center/Supply Service Center CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 11819-357_0e6315f2-49bd-471a-ab04-2949077728d0 11819-357 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 HHS/Program Support Center/Supply Service Center IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 11819-360_dd188c20-9c47-4713-bf17-e13ec7959da6 11819-360 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 HHS/Program Support Center/Supply Service Center CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 11819-363_9f2ae085-ffaf-4287-93f0-0d480c2516fd 11819-363 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED ORAL 20111222 ANDA ANDA075817 HHS/Program Support Center/Supply Service Center CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 11819-365_9ac5ef7b-9810-44b2-a5f6-07eac3feecc1 11819-365 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20110726 ANDA ANDA078139 HHS/Program Support Center/Supply Service Center ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 11822-0001_5b1b8e3e-02ed-4c80-ba69-4a6f72b1a27f 11822-0001 HUMAN OTC DRUG Rite Aid Anti-Cavity, Anti-Gingivitis Stannous Fluoride PASTE DENTAL 20101208 OTC MONOGRAPH FINAL part355 Rite Aid STANNOUS FLUORIDE 4.54 mg/g 11822-0002_d76ff246-dfa0-496d-98e8-b21807eab6a2 11822-0002 HUMAN OTC DRUG Rite Aid Sensitive Mint Potassium Nirtate and Sodium Fluoride PASTE DENTAL 20100719 OTC MONOGRAPH NOT FINAL part356 Rite Aid POTASSIUM NITRATE; SODIUM FLUORIDE 5; 2.43 mg/g; mg/g 11822-0003_b72e9d6e-0b67-4c27-9d61-db2b9305cfee 11822-0003 HUMAN OTC DRUG First Aid Double Antibiotic bacitracin zinc, polymyxin B sulfate OINTMENT TOPICAL 20060616 OTC MONOGRAPH FINAL part333B Rite Aid BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g 11822-0004_5a97cfe3-9822-4659-9505-3ed087772688 11822-0004 HUMAN OTC DRUG Anticavity Fluoride Rinse Anticavity Fluoride MOUTHWASH ORAL 20040408 OTC MONOGRAPH FINAL part355 Rite Aid SODIUM FLUORIDE .05 mL/L 11822-0008_fe37c90b-b087-40db-8f89-ec67c0a0de11 11822-0008 HUMAN OTC DRUG Pain Relief Acetaminophen SUSPENSION/ DROPS ORAL 19970922 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 80 mg/.8mL 11822-0010_2b557b22-7efa-409a-8fe7-c1923e41fce8 11822-0010 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20040506 ANDA ANDA076359 Rite Aid Corporation IBUPROFEN 100 mg/1 11822-0012_3725609b-b031-4c90-a81e-d216e0a66ae4 11822-0012 HUMAN OTC DRUG Junior Pain Relief Acetaminophen TABLET, ORALLY DISINTEGRATING ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN 160 mg/1 11822-0013_cc57e2fe-0b00-47b4-aa05-10aba6af4c89 11822-0013 HUMAN OTC DRUG Allergy and Congestion Relief Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20130725 ANDA ANDA076050 Rite Aid Corporation LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 11822-0018_4905528b-3a35-48d7-bdc2-2788bcedc20b 11822-0018 HUMAN OTC DRUG Tussin Cough and Chest Congestion DM Robitussin DM LIQUID ORAL 20131115 OTC MONOGRAPH FINAL part341 Rite Aid DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 11822-0018_9e9ba46f-807f-4cb7-ae44-1882684fe8ca 11822-0018 HUMAN OTC DRUG Tussin Cough and Chest Congestion DM Robitussin DM LIQUID ORAL 20131115 OTC MONOGRAPH FINAL part341 Rite Aid DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 11822-0022_075e2d68-d872-4fd8-a9a0-4abbff162a98 11822-0022 HUMAN OTC DRUG acid reducer Cimetidine TABLET ORAL 20050708 ANDA ANDA075285 Rite Aid Corporation CIMETIDINE 200 mg/1 11822-0025_2fdaade6-1b63-4ccb-9d6b-b4e1a7a942a2 11822-0025 HUMAN OTC DRUG Childrens Allergy Relief Benadryl LIQUID ORAL 20131118 OTC MONOGRAPH FINAL part341 Rite Aid DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 11822-0028_69160de9-3fc0-4e95-bcf9-0455230d5988 11822-0028 HUMAN OTC DRUG UNDECYLENIC ACID UNDECYLENIC ACID LIQUID TOPICAL 20080601 OTC MONOGRAPH FINAL part333C RiteAid UNDECYLENIC ACID 288 mg/mL 11822-0041_270adc5a-ae88-4482-9f35-a21a59ebc55a 11822-0041 HUMAN OTC DRUG Nite Time Cold and Flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate LIQUID ORAL 20060509 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 11822-0047_44631bdd-393c-4d6c-a826-db3fb20750d8 11822-0047 HUMAN OTC DRUG acid reducer Ranitidine TABLET ORAL 20081203 ANDA ANDA078653 Rite Aid Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 11822-0050_8cd38c88-0a77-4773-944d-2734fe947b6a 11822-0050 HUMAN OTC DRUG ibuprofen pm Diphenhydramine Citrate, Ibuprofen TABLET, COATED ORAL 20090319 ANDA ANDA079113 Rite Aid Corporation DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 11822-0054_438e1514-a0a5-4d06-8be0-b93fcf1df374 11822-0054 HUMAN OTC DRUG Suphedrine Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020813 ANDA ANDA075153 Rite Aid Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 11822-0056_85e9e6fb-628c-4e84-b2e2-a5cb6537ac09 11822-0056 HUMAN OTC DRUG nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140619 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 11822-0057_1250ec8d-60d6-4c1f-9869-0c93500b7c3c 11822-0057 HUMAN OTC DRUG ibuprofen ibuprofen SUSPENSION ORAL 20040506 ANDA ANDA075217 Rite Aid Corporation IBUPROFEN 50 mg/1.25mL 11822-0065_50cd5c30-b845-43d6-a7d3-bdcd06cf8a5d 11822-0065 HUMAN OTC DRUG nasal Oxymetazoline HCl SPRAY NASAL 19961205 OTC MONOGRAPH FINAL part341 Rite Aid Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 11822-0067_3245f03f-0d64-4207-8ac6-640ea75faaca 11822-0067 HUMAN OTC DRUG triple antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20050801 OTC MONOGRAPH FINAL part333B Rite Aid Corporation BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 11822-0072_848d786b-8386-4855-8b10-7171514b8f08 11822-0072 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol MOUTHWASH ORAL 19970801 OTC MONOGRAPH NOT FINAL part348 Rite Aid EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 11822-0073_c853ca2f-b4c7-498e-8e08-46c7463e6e00 11822-0073 HUMAN OTC DRUG triple antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20140625 OTC MONOGRAPH FINAL part333B Rite Aid Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 11822-0081_0a9bbc5a-bc61-439e-b7ea-35247478e10c 11822-0081 HUMAN OTC DRUG ZINC OXIDE ZINC OXIDE OINTMENT TOPICAL 20090519 OTC MONOGRAPH FINAL part347 RiteAid ZINC OXIDE 200 mg/g 11822-0083_fc5cb565-9c65-4a31-b24b-c30e1a60cc67 11822-0083 HUMAN OTC DRUG ibu profen cold and sinus Ibuprofen, Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011008 ANDA ANDA074567 Rite Aid Corporation IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 11822-0091_48527cf7-697a-4b11-b934-2f43c18f3389 11822-0091 HUMAN OTC DRUG Complete Beauty octinoxate, zinc oxide LOTION TOPICAL 20100313 OTC MONOGRAPH FINAL part352 Rite Aid OCTINOXATE; ZINC OXIDE 60; 30 mg/mL; mg/mL 11822-0094_edc8bee3-7521-452c-a82a-2dcc7c82c107 11822-0094 HUMAN OTC DRUG Hair Regrowth Treatment for Men Extra Strength Minoxidil SOLUTION TOPICAL 20051101 ANDA ANDA075518 Rite Aid MINOXIDIL 50 mg/mL 11822-0098_3687f442-6f1b-4144-996b-fff76dd17230 11822-0098 HUMAN OTC DRUG Childrens Allergy Relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Rite Aid Corporation LORATADINE 5 mg/5mL 11822-0100_76a8ceb6-2a59-485b-b345-c02beefd5d17 11822-0100 HUMAN OTC DRUG Tussin Cough and Chest Congestion DM Sugar Free Robitussin Sugar Free Cough LIQUID ORAL 20131115 OTC MONOGRAPH FINAL part341 Rite Aid DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 11822-0101_e7f2b977-e53c-4c8d-82ef-9c28190c1eb7 11822-0101 HUMAN OTC DRUG Multi-Symptom Cold and Cough Daytime Nighttime Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 Rite Aid 11822-0104_7485609c-cc32-4e0c-a9a3-1f23eda6f872 11822-0104 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 19900713 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN 325 mg/1 11822-0105_a2261a1c-cb65-4406-90c4-3068c7e2d379 11822-0105 HUMAN OTC DRUG Childrens Non Aspirin Acetaminophen SUSPENSION ORAL 19970226 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/5mL 11822-0107_97e299e6-a0e9-4aa0-9553-c303cf80c09b 11822-0107 HUMAN OTC DRUG childrens fever reducer and pain reliever Acetaminophen SUSPENSION ORAL 19970226 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/5mL 11822-0110_997915f6-59ce-4d54-8caa-60fca16a1c66 11822-0110 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part335 Rite Aid BISMUTH SUBSALICYLATE 262 mg/15mL 11822-0110_f9361ab0-d3d4-4882-b25e-ba9c9186793d 11822-0110 HUMAN OTC DRUG Peptic Relief BISMUTH SUBSALICYLATE SUSPENSION ORAL 20091016 OTC MONOGRAPH FINAL part335 Rite Aid BISMUTH SUBSALICYLATE 262 mg/15mL 11822-0112_6e08cec3-712a-4a28-be50-5d4364c4f92e 11822-0112 HUMAN OTC DRUG Suphedrine Pseudoephedrine HCl TABLET ORAL 19810825 OTC MONOGRAPH FINAL part341 Rite Aid PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 11822-0117_2791bbbf-8bac-4e4e-8e9c-1eb0fec14853 11822-0117 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 Rite Aid Corporation LANSOPRAZOLE 15 mg/1 11822-0126_9983fedf-ce8c-4392-b6c4-f84f6a6e71be 11822-0126 HUMAN OTC DRUG Tussin CF Robitussin CF LIQUID ORAL 20131113 OTC MONOGRAPH FINAL part341 Rite Aid DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 11822-0130_799092b3-1fee-45e1-9ce1-dc561a4d6305 11822-0130 HUMAN OTC DRUG Non Aspirin Childrens Acetaminophen SUSPENSION ORAL 19970923 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/5mL 11822-0137_4990d323-6273-41cc-b7f6-0ab67de8c94b 11822-0137 HUMAN OTC DRUG Gas Relief Simethicone TABLET, CHEWABLE ORAL 19940728 OTC MONOGRAPH FINAL part332 Rite Aid DIMETHICONE 80 mg/1 11822-0141_92e51445-1347-45d1-abd2-3e02f4bcd411 11822-0141 HUMAN OTC DRUG acid reducer original strength Famotidine TABLET ORAL 20090910 ANDA ANDA075400 Rite Aid Corporation FAMOTIDINE 10 mg/1 11822-0148_29bf2730-eded-4e6d-a674-72ddc3af1076 11822-0148 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen Acetaminophen TABLET ORAL 19930121 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN 500 mg/1 11822-0150_078a8e4f-2297-4f1b-8126-4c52827a79e6 11822-0150 HUMAN OTC DRUG cold and flu relief daytime nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20121013 OTC MONOGRAPH FINAL part341 Rite Aid Corporation 11822-0154_231cdc2a-8295-47aa-9aea-cd43e4796316 11822-0154 HUMAN OTC DRUG Anitfungal foot care tolnaftate SPRAY TOPICAL 20040924 OTC MONOGRAPH FINAL part333C Rite Aid Corporation TOLNAFTATE 1 g/100g 11822-0157_07f39bce-cd72-4195-8882-8c91864eacea 11822-0157 HUMAN OTC DRUG Pain Relief Aspirin Aspirin TABLET ORAL 20060210 OTC MONOGRAPH NOT FINAL part343 Rite Aid ASPIRIN 325 mg/1 11822-0160_7f93a84b-d32f-4a12-9fe6-850bb09c6207 11822-0160 HUMAN OTC DRUG hemorrhoidal relief cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20130131 OTC MONOGRAPH FINAL part346 Rite Aid Corporation COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g 11822-0161_b08c330d-286e-4daf-ba54-4dba676c2e2c 11822-0161 HUMAN OTC DRUG fever reducer and pain reliever Acetaminophen LIQUID ORAL 20111207 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/5mL 11822-0166_960415f8-4f49-41de-a5fa-c570566bd2fd 11822-0166 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20020510 ANDA ANDA074937 Rite Aid Corporation IBUPROFEN 100 mg/5mL 11822-0173_179ec202-997e-45af-9e9d-917824a46aa1 11822-0173 HUMAN OTC DRUG lice Piperonyl Butoxide, Pyrethrum Extract KIT 20111019 OTC MONOGRAPH FINAL part358G Rite Aid Corporation 11822-0173_d4ab418e-c783-40b0-98dd-d6d2c89b20ca 11822-0173 HUMAN OTC DRUG lice Piperonyl Butoxide, Pyrethrum Extract KIT 20071003 OTC MONOGRAPH FINAL part358G Rite Aid Corporation 11822-0175_88a27086-21d1-4b6e-814e-2838a50926b4 11822-0175 HUMAN OTC DRUG childrens non aspirin Acetaminophen SUSPENSION ORAL 19960105 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/5mL 11822-0176_3b645332-6bad-447d-9ef5-8d20aea261f8 11822-0176 HUMAN OTC DRUG CETIRI D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080410 ANDA ANDA077170 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 11822-0179_d6d9724e-d978-4101-a90a-74e48acd7b09 11822-0179 HUMAN OTC DRUG First Aid Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin-b sulfate OINTMENT TOPICAL 20060616 OTC MONOGRAPH FINAL part333B Rite Aid BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 11822-0180_1cc4e6a1-7a41-4e05-b77a-6249c30e0ee9 11822-0180 HUMAN OTC DRUG Healing for Babies Petrolatum OINTMENT TOPICAL 20110520 OTC MONOGRAPH FINAL part347 Rite Aid PETROLATUM 41 kg/100kg 11822-0183_050e4b0b-7cbf-448f-b9e4-0e36f3515da0 11822-0183 HUMAN OTC DRUG Buffered Aspirin Aspirin TABLET ORAL 19900330 OTC MONOGRAPH NOT FINAL part343 Rite Aid ASPIRIN 325 mg/1 11822-0188_12f226f8-73d3-48eb-96ac-4a10e26c7e7f 11822-0188 HUMAN OTC DRUG hemorrhoidal relief mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140320 OTC MONOGRAPH FINAL part346 Rite Aid Corporation MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 11822-0189_18256367-341c-4a81-a622-5145457f183c 11822-0189 HUMAN OTC DRUG sleep aid diphenhydramine hcl TABLET ORAL 19900410 OTC MONOGRAPH FINAL part338 Rite Aid DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 11822-0190_34a3402e-b6a9-4706-aef4-fb035b0c2265 11822-0190 HUMAN OTC DRUG Allergy Relief Diphenhydramine CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part336 Rite Aid DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 11822-0194_b4c26670-a8cf-4e46-b127-54d49b36b12b 11822-0194 HUMAN OTC DRUG acid reducer maximum strength Famotidine TABLET ORAL 20060929 ANDA ANDA077351 Rite Aid Corporation FAMOTIDINE 20 mg/1 11822-0198_89802a07-e8e1-41c8-93f6-9539e123aa8b 11822-0198 HUMAN OTC DRUG Motion Sickness Relief Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 Rite Aid DIMENHYDRINATE 50 mg/1 11822-0199_8901f8ed-8960-4ecd-98ef-26407af9b4a2 11822-0199 HUMAN OTC DRUG miconazole 1 feminine care Miconazole nitrate KIT 20100609 ANDA ANDA079114 Rite Aid Corporation 11822-0200_d722fa9b-f57a-4feb-9efa-35cdace5500d 11822-0200 HUMAN OTC DRUG Childrens Fever Reducer and Pain Reliever Acetaminophen SUSPENSION ORAL 19960105 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/5mL 11822-0207_01d8c276-9c81-4e58-a563-f0416935708a 11822-0207 HUMAN OTC DRUG anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 19960612 UNAPPROVED DRUG OTHER Rite Aid Corporation DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 11822-0210_feaf3fb4-75f3-40b3-bb50-d78bfac3c077 11822-0210 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090923 OTC MONOGRAPH FINAL part341 Rite Aid BISMUTH SUBSALICYLATE 525 mg/15mL 11822-0213_a29ff817-298f-42a8-9757-9c25e33d2a59 11822-0213 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20050225 OTC MONOGRAPH FINAL part355 Rite Aid SODIUM FLUORIDE .05 kg/100L 11822-0217_6008a714-bd22-42c2-a101-0581595351f4 11822-0217 HUMAN OTC DRUG acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130921 ANDA ANDA075077 Rite Aid Corporation ACETAMINOPHEN 650 mg/1 11822-0220_f5cd1c24-b081-46f3-81f1-162d226ebd7e 11822-0220 HUMAN OTC DRUG Clotrimazole 7 clotrimazole CREAM VAGINAL 19961122 ANDA ANDA074165 Rite Aid CLOTRIMAZOLE 1 g/100g 11822-0223_d7bc37aa-59ef-4b9e-a2eb-d9b86a70319e 11822-0223 HUMAN OTC DRUG acid reducer plus antacid Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20100603 ANDA ANDA077355 Rite Aid Corporation CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 11822-0226_da31ccf7-c5a0-4245-be42-2890ed4601b7 11822-0226 HUMAN OTC DRUG Stay Alert Aid Caffeine TABLET ORAL 19921121 OTC MONOGRAPH FINAL part340 Rite Aid CAFFEINE 200 mg/1 11822-0227_be9f1797-16c7-4d2f-bb8c-eb9f4fc8288c 11822-0227 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, COATED ORAL 20051107 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 500 mg/1 11822-0250_4135e2f1-2c9c-40f9-8455-c6241bb5cddd 11822-0250 HUMAN OTC DRUG Rite Aid Fungal UNDECYLENIC ACID LIQUID TOPICAL 20080601 OTC MONOGRAPH FINAL part333C Rite Aid Corporation UNDECYLENIC ACID 288 mg/mL 11822-0251_6e605eaf-faf0-42fd-b208-f8da75f40868 11822-0251 HUMAN OTC DRUG arthritic pain Trolamine Salicylate CREAM TOPICAL 20050723 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation TROLAMINE SALICYLATE 10 g/100g 11822-0255_99a76de3-166a-4902-b400-b262a4fa0ae8 11822-0255 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20050603 ANDA ANDA075217 Rite Aid Corporation IBUPROFEN 50 mg/1.25mL 11822-0271_b9a0dc74-c0a2-4ba4-ba92-8fe880331a47 11822-0271 HUMAN OTC DRUG acid reducer Ranitidine TABLET ORAL 20111104 ANDA ANDA076760 Rite Aid Corporation RANITIDINE HYDROCHLORIDE 75 mg/1 11822-0279_28b1093f-5138-4a7a-a0b7-4c3810cc447b 11822-0279 HUMAN OTC DRUG Rite Aid Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL 11822-0291_c35c0d6d-9b78-4639-81c2-49a83367931e 11822-0291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 Rite Aid IBUPROFEN 200 mg/1 11822-0292_4d3d7c21-f61c-4619-af4b-5ecd93146d21 11822-0292 HUMAN OTC DRUG Pain Relief Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 Rite Aid IBUPROFEN 200 mg/1 11822-0294_c1d2b7be-0bc1-4308-ae8d-817dcb3787c2 11822-0294 HUMAN OTC DRUG renewal for men Minoxidil AEROSOL, FOAM TOPICAL 20120314 ANDA ANDA091344 Rite Aid Corporation MINOXIDIL 5 g/100g 11822-0296_c1869591-d639-4f29-872f-0a9d27ed2dcf 11822-0296 HUMAN OTC DRUG Multi Symptom Cold CF dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20131206 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL 11822-0299_1f5966f4-4d01-4636-a375-cca8966bebbd 11822-0299 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20010913 OTC MONOGRAPH FINAL part336 Rite Aid DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 11822-0300_26fb9b5e-2627-45ea-a0ec-2eda07bc34ac 11822-0300 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090918 OTC MONOGRAPH NOT FINAL part356 Rite Aid HYDROGEN PEROXIDE 2.65 mL/100mL 11822-0304_90e0426b-654f-4bcd-8b1d-cf56d1fc0c68 11822-0304 HUMAN OTC DRUG nasal oxymetazoline hydrochloride SPRAY NASAL 20131219 OTC MONOGRAPH FINAL part341 Rite Aid Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 11822-0306_c643fb56-e482-4fa3-8716-d6a7fe28f66f 11822-0306 HUMAN OTC DRUG Laxative Polyethylene Glycol 3350 POWDER ORAL 20091009 ANDA ANDA090685 Rite Aid Corporation POLYETHYLENE GLYCOL 3350 17 g/17g 11822-0308_b6be6977-db88-459a-a9c0-7f3600b211bc 11822-0308 HUMAN OTC DRUG daytime cold relief multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20071022 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 11822-0310_93805b77-b35b-434d-952d-509a14257a9c 11822-0310 HUMAN OTC DRUG Adult Tussin Guaifenesin SYRUP ORAL 20130921 OTC MONOGRAPH FINAL part341 Rite Aid Corporation GUAIFENESIN 100 mg/5mL 11822-0316_5b5627f3-7187-4c61-968f-227945897c01 11822-0316 HUMAN OTC DRUG Rite Aid Maximum Strength Benzocaine GEL, DENTIFRICE ORAL 20110120 OTC MONOGRAPH FINAL part333B Rite Aid BENZOCAINE 20 g/100g 11822-0317_4f5c75b0-7562-4dda-8418-418587c843a6 11822-0317 HUMAN OTC DRUG Rite Aid Maximum Strength Benzocaine GEL, DENTIFRICE ORAL 20110120 OTC MONOGRAPH NOT FINAL part333A Rite Aid BENZALKONIUM CHLORIDE; BENZOCAINE; ZINC CHLORIDE .04; 20; .1 g/100g; g/100g; g/100g 11822-0319_cafdff9f-6af3-43a9-a886-261657e9b5db 11822-0319 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate TABLET, CHEWABLE ORAL 19980716 OTC MONOGRAPH FINAL part335 Rite Aid BISMUTH SUBSALICYLATE 262 mg/1 11822-0321_93d2f86e-948a-4d71-8c0f-379ae1ad4955 11822-0321 HUMAN OTC DRUG acid reducer complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20090515 ANDA ANDA077355 Rite Aid Corporation CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 11822-0323_2cf8b06b-3a29-4d38-9f9b-fa373bc1e66c 11822-0323 HUMAN OTC DRUG Lubricant Eye Plus carboxymethylcellulose sodium SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130916 OTC MONOGRAPH FINAL part349 Rite Aid Corporation CARBOXYMETHYLCELLULOSE SODIUM .5 g/100mL 11822-0326_630a2137-a032-46e2-8a25-99579b12ec6f 11822-0326 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20050212 OTC MONOGRAPH NOT FINAL part334 Rite Aid BISACODYL 5 mg/1 11822-0327_6fad95fa-f46f-4573-9a1c-193415c3610f 11822-0327 HUMAN OTC DRUG Laxative Bisacodyl TABLET ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 Rite Aid BISACODYL 5 mg/1 11822-0329_f9dc6a70-face-4a4d-a3a9-3c47e8e914e3 11822-0329 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 Rite Aid DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 11822-0335_bc245e1f-9a17-47df-bcad-03167a98d652 11822-0335 HUMAN OTC DRUG nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120907 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 11822-0337_65e06fa6-d71d-47c6-9393-115aaf35d168 11822-0337 HUMAN OTC DRUG stomach relief Bismuth subsalicylate SUSPENSION ORAL 20120711 OTC MONOGRAPH FINAL part335 Rite Aid Corporation BISMUTH SUBSALICYLATE 1050 mg/30mL 11822-0338_0e8b11d1-ce6d-455c-b692-1277ff4d157c 11822-0338 HUMAN OTC DRUG Backache Relief Magnesium Salicylate Tetrahydrate CAPSULE ORAL 19981107 OTC MONOGRAPH NOT FINAL part343 Rite Aid MAGNESIUM SALICYLATE 580 mg/1 11822-0340_bee8a0c3-4cc2-4108-883c-5d8403e60377 11822-0340 HUMAN OTC DRUG Arthritis Creme Trolamine Salicylate CREAM TOPICAL 20050723 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation TROLAMINE SALICYLATE 10 g/100g 11822-0342_e097d088-23df-46a1-81e5-85efb7d51b78 11822-0342 HUMAN OTC DRUG tussin mucus and chest congestion Guaifenesin SYRUP ORAL 20140729 OTC MONOGRAPH FINAL part341 Rite Aid Corporation GUAIFENESIN 200 mg/10mL 11822-0344_456e127a-3be0-406b-828b-db95d9b4208f 11822-0344 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20060224 ANDA ANDA077007 Rite Aid Corporation NICOTINE 2 mg/1 11822-0346_5bc06d7a-8953-405a-a09a-dccffd44176a 11822-0346 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate CAPSULE ORAL 20110506 OTC MONOGRAPH FINAL part335 Rite Aid BISMUTH SUBSALICYLATE 262 mg/1 11822-0348_04f0bd8e-1eb3-49c3-b92a-faf3eb611900 11822-0348 HUMAN OTC DRUG Laxative Sennosides TABLET ORAL 20030104 OTC MONOGRAPH NOT FINAL part334 Rite Aid SENNOSIDES 25 mg/1 11822-0350_c5274250-99a8-4a9b-aeb6-1c010b5f2899 11822-0350 HUMAN OTC DRUG Foot Care Clotrimazole clotrimazole CREAM TOPICAL 20100312 OTC MONOGRAPH FINAL part333C Rite Aid CLOTRIMAZOLE 10 mg/g 11822-0351_8958e12b-9ba6-4cd8-97aa-1586369c4ff9 11822-0351 HUMAN OTC DRUG Antifungal Cream clotrimazole CREAM TOPICAL 20110415 OTC MONOGRAPH FINAL part333C Rite Aid CLOTRIMAZOLE 10 mg/g 11822-0359_bc05bf95-4d1b-4fc4-a181-fc7e71303afc 11822-0359 HUMAN OTC DRUG Cough and Chest Congestion DM Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20130921 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 11822-0368_998a8214-1def-4e35-8339-c631d604dedf 11822-0368 HUMAN OTC DRUG naproxen sodium all day pain relief Naproxen Sodium TABLET, FILM COATED ORAL 20010516 ANDA ANDA074661 Rite Aid Corporation NAPROXEN SODIUM 220 mg/1 11822-0369_b3bb9a4c-d422-4561-8245-18d2b79bc826 11822-0369 HUMAN OTC DRUG Anti itch Hydrocortisone CREAM TOPICAL 20090209 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation HYDROCORTISONE 1 g/100g 11822-0370_0c4c3c31-edac-4338-92e8-c01a49a2dd46 11822-0370 HUMAN OTC DRUG Rite Aid Maximum Strength Itch Relief DIPHENHYDRAMINE HYDROCHLORIDE GEL TOPICAL 20110810 OTC MONOGRAPH FINAL part336 RITE AID CORPORATION DIPHENHYDRAMINE HYDROCHLORIDE 20.5 mg/mL 11822-0371_e1af9632-965f-49a2-9412-deb6e16bd31f 11822-0371 HUMAN OTC DRUG Rite Aid Maximum Strength Itch Relief DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE SPRAY TOPICAL 20110810 OTC MONOGRAPH FINAL part336 RITE AID CORPORATION DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/mL; mg/mL 11822-0373_123bed7e-d85b-43ae-a2f4-bc3304a4fac1 11822-0373 HUMAN OTC DRUG PM pain reliever Acetaminophen and Diphenhydramine Citrate TABLET ORAL 20040607 OTC MONOGRAPH FINAL part338 Rite Aid ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 11822-0374_3e1c8709-3a42-4793-a898-b77fd6a618fa 11822-0374 HUMAN OTC DRUG migraine relief Acetaminophen, Aspirin, Caffeine TABLET ORAL 20020514 ANDA ANDA075794 Rite Aid Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 11822-0375_26b6cd8e-5fab-48c8-b671-e61d2aefbc8c 11822-0375 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 Rite Aid LOPERAMIDE HYDROCHLORIDE 2 mg/1 11822-0376_c25863db-babb-4b5a-9df5-24c96a7c6a71 11822-0376 HUMAN OTC DRUG Rite Aid Diaper Rash ZINC OXIDE OINTMENT TOPICAL 20100720 OTC MONOGRAPH NOT FINAL part352 RiteAid Corporation ZINC OXIDE 400 mg/g 11822-0377_40204b82-b7c6-447a-89b0-3571bfa83ff7 11822-0377 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl SOLUTION ORAL 19920713 ANDA ANDA073243 Rite Aid Corporation LOPERAMIDE HYDROCHLORIDE 1 mg/5mL 11822-0378_6a04b548-180e-409e-a8c0-6c2f5038fc0b 11822-0378 HUMAN OTC DRUG Advanced Firming and Anti Wrinkle Ensulizole, Octinoxate CREAM TOPICAL 20100210 OTC MONOGRAPH NOT FINAL part352 Rite Aid Corporation ENSULIZOLE; OCTINOXATE 2; 7.5 g/100g; g/100g 11822-0384_ef32b634-9ed0-40d3-a48a-5ced33729698 11822-0384 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120827 ANDA ANDA091135 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 11822-0386_69499709-91c7-43ec-b2b6-154590ba46da 11822-0386 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 20010411 ANDA ANDA040564 Rite Aid DOXYLAMINE SUCCINATE 25 mg/1 11822-0390_03741fd9-5f1f-47d5-a4b4-ca93e3493765 11822-0390 HUMAN OTC DRUG Menstrual Complete Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 11822-0391_6e281647-fa10-48e9-a3c8-eb7d0767bcb9 11822-0391 HUMAN OTC DRUG Menstrual Relief Acetaminophen, Caffeine, Pyrilamine maleate CAPSULE, LIQUID FILLED ORAL 20010614 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 11822-0392_911a6ec6-47df-42d9-92af-704c770b9ced 11822-0392 HUMAN OTC DRUG pain relief ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20020330 ANDA ANDA075139 Rite Aid IBUPROFEN 200 mg/1 11822-0393_0b3add4d-b2ee-4ce4-9ba2-13a4795413b0 11822-0393 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20020408 ANDA ANDA075139 Rite Aid IBUPROFEN 200 mg/1 11822-0397_e5d91d0f-fe69-4e99-b4ad-92e499dc5e82 11822-0397 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 20010904 OTC MONOGRAPH NOT FINAL part343 Rite Aid ASPIRIN 81 mg/1 11822-0400_cd3346bd-ad20-44e7-b9c9-84d835c924ef 11822-0400 HUMAN OTC DRUG Hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 20050725 OTC MONOGRAPH FINAL part346 Rite Aid Corporation MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 11822-0401_6e7ae3f0-68b6-4176-a05b-330ffce141cd 11822-0401 HUMAN OTC DRUG nausea relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20141104 UNAPPROVED DRUG OTHER Rite Aid Corporation DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 11822-0402_e605f485-6777-4f85-b1ad-ec9416b80850 11822-0402 HUMAN OTC DRUG Night Time Cough Cherry DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20090811 OTC MONOGRAPH FINAL part341 Rite Aid DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 135 mg/15mL; mg/5mL 11822-0403_3a12e01a-49a4-434d-9b24-a944e095d47c 11822-0403 HUMAN OTC DRUG Night Time Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20091016 OTC MONOGRAPH FINAL part341 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 11822-0404_64ec0c8a-5c0d-4030-9d2c-b0ba78aecf99 11822-0404 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET, CHEWABLE ORAL 20020529 OTC MONOGRAPH FINAL part336 Rite Aid MECLIZINE HYDROCHLORIDE 25 mg/1 11822-0405_39d50907-350c-4068-b4cd-a1d55522fad8 11822-0405 HUMAN OTC DRUG CVS Fragrance Free Anti-Itch PRAMOXINE HYDROCHLORIDE LOTION TOPICAL 20100708 OTC MONOGRAPH NOT FINAL part348 RITE AID CORPORATION PRAMOXINE HYDROCHLORIDE 10 mg/mL 11822-0406_7dfafb22-9a79-4cbb-ad09-266755325927 11822-0406 HUMAN OTC DRUG Rite Aid Ultra Strength Muscle Rub MENTHOL, CAMPHOR, AND METHYLSALICYLATE OINTMENT TOPICAL 20110328 OTC MONOGRAPH NOT FINAL part348 RITE AID CORPORATION CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g 11822-0407_a8cb6669-b661-47b2-a7cf-92603354674b 11822-0407 HUMAN OTC DRUG RITEAID HEMORRHOIDAL COOLING WITCH HAZEL, PHENYLEPHRINE HYDROCHLORIDE GEL TOPICAL 20101118 OTC MONOGRAPH FINAL part346 Rite Aid Corporation PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL 2.5; 500 mg/g; mg/g 11822-0408_10dfc172-6d1e-45a8-90d1-c6d019dd8bb0 11822-0408 HUMAN OTC DRUG Tussin DM Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20090821 OTC MONOGRAPH FINAL part341 Rite Aid DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 11822-0408_545df654-acc9-4566-9b80-8eaadabfcc74 11822-0408 HUMAN OTC DRUG Tussin DM Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20090923 OTC MONOGRAPH FINAL part341 Rite Aid DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 11822-0413_60936b36-d049-484e-bf29-3172c8fbc6cc 11822-0413 HUMAN OTC DRUG Tussin Original Guaifenesin LIQUID ORAL 20090716 OTC MONOGRAPH FINAL part341 Rite Aid GUAIFENESIN 100 mg/5mL 11822-0413_e73da139-ea8f-45a7-83fb-095224e028cf 11822-0413 HUMAN OTC DRUG Tussin Original GUAIFENESIN LIQUID ORAL 20090811 OTC MONOGRAPH FINAL part341 Rite Aid GUAIFENESIN 100 mg/5mL 11822-0414_5c1d24c3-19e0-45ae-b4ec-a1d9d995dc83 11822-0414 HUMAN OTC DRUG Rite Aid Acne Pads, Daily Cleansing Pads SALICYLIC ACID SWAB TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333D Right Aid Corporation SALICYLIC ACID 21 mg/1 11822-0415_6d2e677c-06bd-4d3f-b171-e970ed2a7c90 11822-0415 HUMAN OTC DRUG Rite Aid Soothing Medicated Anit-Itch MENTHOL, PRAMOXINE HYDROCHLORIDE CREAM TOPICAL 20100708 OTC MONOGRAPH FINAL part347 RITE AID CORPORATION MENTHOL; PRAMOXINE HYDROCHLORIDE 10; 10 mg/g; mg/g 11822-0416_b86ae8c6-c6dc-42d7-baca-26ea698103d7 11822-0416 HUMAN OTC DRUG Intensive Healing Anti Itch Hydrocortisone CREAM TOPICAL 20140320 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation HYDROCORTISONE 1 g/100g 11822-0419_75eba71a-690f-4dbe-8a2e-f56840654ef5 11822-0419 HUMAN OTC DRUG Cough childrens mucus relief Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20070816 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 11822-0426_e7f0d196-a8c5-404d-87d2-b4d81148bbcb 11822-0426 HUMAN OTC DRUG tioconazole 1 1 dose treatment Tioconazole OINTMENT VAGINAL 20071213 ANDA ANDA075915 Rite Aid Corporation TIOCONAZOLE 6.5 g/100g 11822-0428_66447b8f-64d8-453f-8293-7997661c955d 11822-0428 HUMAN OTC DRUG Aspirin-Free Tension Headache Acetaminophen, Caffeine CAPSULE ORAL 20070117 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 11822-0439_604e9219-e984-4e3c-92c8-7f1852d8f02b 11822-0439 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20040414 OTC MONOGRAPH NOT FINAL part356 Rite Aid ASPIRIN 81 mg/1 11822-0440_cdaa9a48-0268-4985-b776-3bf46dd2bf32 11822-0440 HUMAN OTC DRUG Hand Sanitizer Ethyl alcohol GEL TOPICAL 20100712 OTC MONOGRAPH NOT FINAL part333A Rite Aid ALCOHOL 585 mg/mL 11822-0442_98d54ed8-a2f2-44e4-b114-32ad67a689de 11822-0442 HUMAN OTC DRUG Long Acting Tussin Cough Gels Dextromethorphan HBr CAPSULE, GELATIN COATED ORAL 20060424 OTC MONOGRAPH FINAL part341 Rite Aid DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 11822-0444_9e6dc195-a742-4a0d-997f-88c786563b6c 11822-0444 HUMAN OTC DRUG antibiotic and pain relief Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20050817 OTC MONOGRAPH FINAL part333B Rite Aid Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 11822-0449_0719b59b-2566-4df2-ae8b-27d2190e5436 11822-0449 HUMAN OTC DRUG Junior Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN 160 mg/1 11822-0450_11bc7139-9e7a-4ca0-89f8-6f8c662b2c52 11822-0450 HUMAN OTC DRUG HEMORRHOID RELIEF COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY RECTAL 20110701 OTC MONOGRAPH FINAL part346 Rite Aid Corporation COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE .855; .0025 g/g; g/g 11822-0452_f2d893ee-dbda-4dba-81f0-f5a03adb01ad 11822-0452 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20041206 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN 80 mg/1 11822-0456_b5d5bdb5-8961-4c8a-9f58-4f23044264a6 11822-0456 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061026 ANDA ANDA076777 Rite Aid Corporation NICOTINE 2 mg/1 11822-0458_1b27615b-6dcb-4c8e-bd39-7abcec1cbc06 11822-0458 HUMAN OTC DRUG allergy relief Cetirizine Hydrochloride TABLET ORAL 20080116 ANDA ANDA078336 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 11822-0459_78c94219-5dd3-4521-a3f3-0fafafb0db8c 11822-0459 HUMAN OTC DRUG nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120907 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 11822-0460_75755502-9992-446f-ae11-a3653e0ebec2 11822-0460 HUMAN OTC DRUG Cold and Flu Acetaminophen and Chlorpheniramine Maleate TABLET, COATED ORAL 20050531 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 325; 2 mg/1; mg/1 11822-0461_85b7790d-2e72-45a5-b70b-d9c2be31d039 11822-0461 HUMAN OTC DRUG Maximum Strength Flu Acetaminophen, Dextromethorphan HBr, Chlorpheniramine maleate TABLET, FILM COATED ORAL 20050601 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 500; 2; 15 mg/1; mg/1; mg/1 11822-0462_cff67230-02b4-4700-9942-bae2708d2807 11822-0462 HUMAN OTC DRUG Sinus and Allergy Relief PE Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20050609 OTC MONOGRAPH FINAL part341 Rite Aid CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 11822-0471_0f7f16cb-07d1-4c6d-ac2e-f3a0ccc7f324 11822-0471 HUMAN OTC DRUG anti itch hydrocortisone OINTMENT TOPICAL 20050725 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation HYDROCORTISONE 1 g/100g 11822-0490_2132db7f-0233-4835-a12c-caea6e1d3825 11822-0490 HUMAN OTC DRUG naproxen sodium Naproxen Sodium TABLET ORAL 20010516 ANDA ANDA074661 Rite Aid Corporation NAPROXEN SODIUM 220 mg/1 11822-0493_f6503794-e062-4be5-81cf-806a2735f4b9 11822-0493 HUMAN OTC DRUG Tussin Long Acting Cough Dextromethorphan Hydrobromide LIQUID ORAL 19970819 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL 11822-0497_29c6e910-23ee-4d66-aa5b-6b2c083728c3 11822-0497 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20110214 OTC MONOGRAPH FINAL part358H Rite Aid COAL TAR 1.02 mg/mL 11822-0498_8e18bd43-773b-41c5-880d-d34cd0755d1c 11822-0498 HUMAN OTC DRUG mucus relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130320 ANDA ANDA078912 Rite Aid Corporation GUAIFENESIN 600 mg/1 11822-0499_60840dfd-93f6-41b7-a3ef-1d7f69d1d2da 11822-0499 HUMAN OTC DRUG Anti Itch Hydrocortisone CREAM TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation HYDROCORTISONE 1 g/100g 11822-0500_5490abe2-11f0-45a8-aefa-f70263ff1da8 11822-0500 HUMAN OTC DRUG Acid Reducer Plus Antacid famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20131108 ANDA ANDA077355 Rite Aid Corporation CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 11822-0503_670aa64b-060c-4d44-babb-da1de2999075 11822-0503 HUMAN OTC DRUG Head Congestion Cold DayTime Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED ORAL 20050804 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 11822-0504_20fc1815-b823-4a5f-a927-07fc70a84f80 11822-0504 HUMAN OTC DRUG Jock Itch Clotrimazole CREAM TOPICAL 20050807 OTC MONOGRAPH FINAL part333C Rite Aid Corporation CLOTRIMAZOLE 1 g/100g 11822-0507_388cea43-5410-4999-a364-e8d0241b904e 11822-0507 HUMAN OTC DRUG naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20010516 ANDA ANDA074661 Rite Aid Corporation NAPROXEN SODIUM 220 mg/1 11822-0509_07368d35-46ce-4f4b-9b8f-96f84b11ab6c 11822-0509 HUMAN OTC DRUG Anti Aging Vitamin Complex Avobenzone, Ensulizole, Octisalate, Octocrylene LOTION TOPICAL 20090421 OTC MONOGRAPH NOT FINAL part352 Rite Aid Corporation AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE 2; 1; 4; 1 mL/100mL; mL/100mL; mL/100mL; mL/100mL 11822-0516_7d80fa11-b505-45ae-a053-eab9a646e287 11822-0516 HUMAN OTC DRUG Adult Tussin Cough and Cold CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20130731 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 11822-0519_116e970d-0ea1-4a21-aa38-76fb68fa40aa 11822-0519 HUMAN OTC DRUG Rapid Release Pain Relief Acetaminophen CAPSULE, LIQUID FILLED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN 500 mg/1 11822-0521_5e526d19-631b-4fb6-b3e1-6e0a76b17226 11822-0521 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20100625 ANDA ANDA076359 Rite Aid Corporation IBUPROFEN 100 mg/1 11822-0527_9726a59e-b434-440f-a78f-9cd56585d5a0 11822-0527 HUMAN OTC DRUG Sinus Congestion and Pain Relief Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, COATED ORAL 20050806 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 11822-0529_4de23fc9-ba2f-4ba1-8dd9-ac0e1c856d86 11822-0529 HUMAN OTC DRUG Multi-Symptom Cold Relief Acetaminophen, Chlorpehniramine HCl, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 Rite Aid 11822-0532_13332962-64a7-460d-811e-36e913844c5f 11822-0532 HUMAN OTC DRUG Mucus Relief Chest Guaifenesin TABLET, COATED ORAL 20051222 OTC MONOGRAPH FINAL part341 Rite Aid GUAIFENESIN 400 mg/1 11822-0542_e2ee82e7-e53c-4b7f-8cca-f24caba2b1bf 11822-0542 HUMAN OTC DRUG Sinus Congestion PE Guaifenesin and Phenylephrine HCl TABLET ORAL 20060415 OTC MONOGRAPH FINAL part341 Rite Aid GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 11822-0543_f73b9382-65a5-435c-807d-bdc5fb81d797 11822-0543 HUMAN OTC DRUG Severe Allergy And Sinus Headache Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET ORAL 20070627 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 11822-0544_e2bb2925-4fc7-4597-8d0c-768a48d8e4f1 11822-0544 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130930 ANDA ANDA075077 Rite Aid Corporation ACETAMINOPHEN 650 mg/1 11822-0546_137be2a0-e184-4033-af1c-ac644983d51d 11822-0546 HUMAN OTC DRUG Non Drowsy Cold and Cough PE Acetaminophen, Dextromathorphan HBr, Gauifenesin, Phenylephrine HCl CAPSULE, COATED ORAL 20070222 OTC MONOGRAPH FINAL part341 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 11822-0548_7215eb20-3264-4052-9c52-65ab2fd9218d 11822-0548 HUMAN OTC DRUG daytime severe cold and flu relief acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140709 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 11822-0549_18c9c634-1076-448d-b0fd-b2ef0cbe8877 11822-0549 HUMAN OTC DRUG lice treatment Permethrin LOTION TOPICAL 20110126 ANDA ANDA076090 Rite Aid Corporation PERMETHRIN 1 mg/100mL 11822-0551_70783ec8-cf65-480b-bdb5-0e7903368ab5 11822-0551 HUMAN OTC DRUG body Menthol, Zinc Oxide POWDER TOPICAL 20030905 OTC MONOGRAPH NOT FINAL part348 Rite Aid MENTHOL; ZINC OXIDE 1.5; 10 mg/g; mg/g 11822-0554_299dee64-65c9-43d8-89fd-7d1fd99f337b 11822-0554 HUMAN OTC DRUG HOME ANTIBACTERIAL Fresh Scent Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Rite Aid Corporation BENZALKONIUM CHLORIDE .115 g/1 11822-0556_4fd55050-c3f8-4201-adc8-d4a6e55dae1d 11822-0556 HUMAN OTC DRUG Acetaminophen PM Acetaminophen and Diphenhydramine HCl CAPSULE ORAL 20071217 OTC MONOGRAPH NOT FINAL part341 Rite Aid ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 11822-0560_580f1fe4-7e85-4f44-a162-f96a015dd9b5 11822-0560 HUMAN OTC DRUG Multi-Symptom Daytime Cold Acetaminophen, Phenylephrine HCl and Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20080329 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 11822-0566_80ca228c-0901-4c9f-ac37-e3a9bcb47a24 11822-0566 HUMAN OTC DRUG allergy and congestion relief d original prescription strength Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080410 ANDA ANDA077170 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 11822-0571_ec7cffaa-b4ce-4f57-9aca-aef352b2fd8e 11822-0571 HUMAN OTC DRUG allergy relief fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110415 ANDA ANDA076447 Rite Aid Corporation FEXOFENADINE HYDROCHLORIDE 180 mg/1 11822-0578_6f98c46d-6ea9-4f68-91e0-12e256d8eac3 11822-0578 HUMAN OTC DRUG Childrens Allergy Relief Cetirizine HCl TABLET, CHEWABLE ORAL 20081031 ANDA ANDA077946 Rite Aid CETIRIZINE HYDROCHLORIDE 10 mg/1 11822-0580_ded29f42-17f1-4016-a651-919aed8fd31b 11822-0580 HUMAN OTC DRUG Daytime Nighttime Cold and Flu Relief Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140613 OTC MONOGRAPH FINAL part341 Rite Aid Corporation 11822-0588_1e61802a-a301-4d34-a23e-8a269e219fa9 11822-0588 HUMAN OTC DRUG Sinus Congestion and Pain Relief Acetaminophen and Phenylephrine HCl CAPSULE ORAL 20080317 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 11822-0590_59fff669-92d9-403e-b6c1-48f0f342ad4a 11822-0590 HUMAN OTC DRUG infants fever reducer and pain reliever acetaminophen LIQUID ORAL 19930908 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/5mL 11822-0595_2a9af8c1-ae78-42a8-b2b2-045df9c9a0c1 11822-0595 HUMAN OTC DRUG childrens fever reducer and pain reliever Acetaminophen SUSPENSION ORAL 19970923 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/5mL 11822-0599_eed6122b-39aa-4799-9aea-81abed1caf5a 11822-0599 HUMAN OTC DRUG Childrens Allergy Relief Diphenhydramine HCl TABLET, CHEWABLE ORAL 20110501 OTC MONOGRAPH FINAL part341 Rite Aid DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 11822-0600_1fafeee0-256f-4248-a207-b64877188b6b 11822-0600 HUMAN OTC DRUG Low Dose Pain Relief Aspirin Aspirin TABLET ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 Rite Aid ASPIRIN 81 mg/1 11822-0603_62015f2b-8533-4586-9507-8ee3bfaea375 11822-0603 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20090416 OTC MONOGRAPH NOT FINAL part334 Rite Aid MINERAL OIL 15 mL/15mL 11822-0608_6de0e1ca-afc5-4d07-80ea-92df30d745a2 11822-0608 HUMAN OTC DRUG Extra Strength Gas Relief Simethicone TABLET ORAL 20130701 OTC MONOGRAPH FINAL part332 Rite Aid DIMETHICONE 125 mg/1 11822-0612_1c052b01-d42e-4ebe-82d5-452e0d7cec04 11822-0612 HUMAN OTC DRUG allergy relief Loratadine TABLET ORAL 20041021 ANDA ANDA076301 Rite Aid Corporation LORATADINE 10 mg/1 11822-0616_1afb72c3-b038-4af2-acdf-d112eabd8818 11822-0616 HUMAN OTC DRUG enema Saline ENEMA RECTAL 20091118 OTC MONOGRAPH NOT FINAL part334 Rite Aid Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 11822-0617_60b3b0cf-9f8e-44bf-9907-e89960ab6722 11822-0617 HUMAN OTC DRUG Maximum Strength Mucus Relief Severe Congestion and Cold Max Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET ORAL 20130407 OTC MONOGRAPH FINAL part341 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 11822-0619_0c23edeb-854b-41c5-8c65-953cd1c21898 11822-0619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20120423 OTC MONOGRAPH FINAL part347 Rite Aid Corporation DIMETHICONE 1.3 kg/100mL 11822-0622_2e6a4b14-3428-4c29-981f-d36d0c893c74 11822-0622 HUMAN OTC DRUG anti itch and skin protectant Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20050730 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 11822-0637_0606322e-dc4c-445e-b171-37608ba5a389 11822-0637 HUMAN OTC DRUG antibiotic plus pain relief maximum strength Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20050714 OTC MONOGRAPH FINAL part333B Rite Aid Corporation NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 11822-0650_aa52d998-cab8-439c-ac95-6c1f5da48ba4 11822-0650 HUMAN OTC DRUG sinus pressure and congestion relief maximum strength Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 19990830 ANDA ANDA075153 Rite Aid Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 11822-0656_338e59b0-770f-477e-8465-3f05293fbf0e 11822-0656 HUMAN OTC DRUG daytime cold and flu relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20120907 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 11822-0660_66dc5b2a-522b-42df-a3ea-524f375fc6a9 11822-0660 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION ORAL 20020510 ANDA ANDA074937 Rite Aid Corporation IBUPROFEN 100 mg/5mL 11822-0662_5782323e-0bac-464e-a73e-07c2bb7d5119 11822-0662 HUMAN OTC DRUG Chlor-Tabs Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Rite Aid CHLORPHENIRAMINE MALEATE 4 mg/1 11822-0664_6945151e-8840-470c-9b4d-b9cd0a16e371 11822-0664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19950721 OTC MONOGRAPH NOT FINAL part356 Rite Aid EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 11822-0667_8490861e-9f07-4883-8572-e64f85d1131f 11822-0667 HUMAN OTC DRUG Hair Regrowth Treatment for Women Minoxidil SOLUTION TOPICAL 20030101 ANDA ANDA074588 Rite Aid MINOXIDIL 2 g/100mL 11822-0668_1aa5fae2-a8ba-43ec-a22c-6385a5b902be 11822-0668 HUMAN OTC DRUG nighttime cough relief Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20020807 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 11822-0669_5f0f5eb5-b8a7-4a61-b56e-5918c4db2e1a 11822-0669 HUMAN OTC DRUG Multi Symptom Cold CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20140724 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 11822-0678_56e22c60-d35e-494e-aa05-07b453e9b538 11822-0678 HUMAN OTC DRUG hemorrhoid relief Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20121012 OTC MONOGRAPH FINAL part346 Rite Aid Corporation MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 11822-0679_d5e782a2-a4d8-49e7-896f-eb4d0bf4b298 11822-0679 HUMAN OTC DRUG Triple Antibiotic Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20050817 OTC MONOGRAPH FINAL part333B Rite Aid Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 11822-0680_1bc50815-5082-4866-a955-ff839cef119d 11822-0680 HUMAN OTC DRUG anti itch maximum strength plus hydrocortisone CREAM TOPICAL 20110216 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation HYDROCORTISONE 1 g/100g 11822-0684_f399a188-ccc2-46c2-9994-75d183475c67 11822-0684 HUMAN OTC DRUG PETROLATUM and LANOLIN PETROLATUM and LANOLIN OINTMENT TOPICAL 20090519 OTC MONOGRAPH FINAL part347 RiteAid LANOLIN; PETROLATUM .155; .534 g/g; g/g 11822-0691_3389e1e4-6288-4a4e-a1b2-111917aa0f91 11822-0691 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19980414 OTC MONOGRAPH FINAL part340 Rite Aid CAFFEINE 200 mg/1 11822-0692_e2c9992d-60f8-4a77-b3fe-2d5ddf5993ce 11822-0692 HUMAN OTC DRUG cool heat Menthol, Methyl salicylate CREAM TOPICAL 20050726 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g 11822-0695_065a5fa2-e9ce-4f5e-aa6d-62eaef9156f9 11822-0695 HUMAN OTC DRUG jock itch Tolnaftate SPRAY TOPICAL 20041012 OTC MONOGRAPH FINAL part333C Rite Aid Corporation TOLNAFTATE 1 g/100g 11822-0701_129ec705-dab6-4e71-900a-1ee5d4945ce5 11822-0701 HUMAN OTC DRUG antifungal Tolnaftate CREAM TOPICAL 20050723 OTC MONOGRAPH FINAL part333C Rite Aid Corporation TOLNAFTATE 1 g/100g 11822-0708_7f7c7ba4-0f19-46fe-a55d-1b3042262ceb 11822-0708 HUMAN OTC DRUG Regular Strength Pain Relief Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH FINAL part343 Rite Aid ASPIRIN 325 mg/1 11822-0710_8d41defe-8120-4cbb-b42e-c805cc5a794b 11822-0710 HUMAN OTC DRUG Daytime Severe Cold and Flu Relief acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SUSPENSION ORAL 20140618 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 11822-0730_3355a3b5-0fab-4d3f-ac3c-47e4a9933bf7 11822-0730 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20010301 ANDA ANDA074164 Rite Aid MICONAZOLE NITRATE 2 g/100g 11822-0734_1dc790b5-9b43-4962-9947-a028557bb15b 11822-0734 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20130119 ANDA ANDA203690 Rite Aid Corporation NICOTINE 2 mg/1 11822-0737_c80f0e4a-4edb-4360-823c-3807ad5b1894 11822-0737 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100609 ANDA ANDA079114 Rite Aid Corporation 11822-0742_ce9e73b0-89b6-4ea8-8f0c-19d8d9976520 11822-0742 HUMAN OTC DRUG naproxen sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20101215 NDA NDA021920 Rite Aid Corporation NAPROXEN SODIUM 220 mg/1 11822-0751_df30b6ac-5d22-448b-9d48-d169c5219f02 11822-0751 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen, Aspirin, Caffeine CAPSULE, GELATIN COATED ORAL 20090109 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 11822-0763_9a71e8eb-4195-4694-bf3e-44f691ff2cef 11822-0763 HUMAN OTC DRUG severe cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SUSPENSION ORAL 20140627 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 11822-0766_3f6d7db9-7c3c-4a39-8a2c-008f4ac39863 11822-0766 HUMAN OTC DRUG infants fever reducer and pain reliever Acetaminophen LIQUID ORAL 20111207 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/5mL 11822-0775_3919fc31-7abc-445d-9928-0a85df2f233d 11822-0775 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 Rite Aid MECLIZINE HYDROCHLORIDE 25 mg/1 11822-0799_3aeb68d9-2816-4719-ba36-07dd7247a23e 11822-0799 HUMAN OTC DRUG cough and chest congestion dm max Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20111007 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 11822-0800_78b6ac87-3de0-44e9-9e28-b4c7ab028fd5 11822-0800 HUMAN OTC DRUG Miconazole 3 Miconazole nitrate KIT 20140212 ANDA ANDA076357 Rite Aid Corporation 11822-0809_face7dc1-9ae2-4f19-909d-ae8c09961068 11822-0809 HUMAN OTC DRUG Antibiotic Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20050804 OTC MONOGRAPH FINAL part333 Rite Aid Corporation NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 11822-0812_e5d46926-fbf6-4973-aae2-8b7c37e753c6 11822-0812 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN 500 mg/1 11822-0817_e6888a71-1fb6-465a-b262-98b83b076c99 11822-0817 HUMAN OTC DRUG Nasal oxymetazoline hydrochloride SPRAY NASAL 20130930 OTC MONOGRAPH FINAL part341 Rite Aid Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 11822-0821_2bd3226e-ee3f-4a9b-9b3e-f6ebd4cc0284 11822-0821 HUMAN OTC DRUG Rite Aid Sensitive Toothpaste Extra Whitening Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20100830 OTC MONOGRAPH NOT FINAL part356 Rite Aid POTASSIUM NITRATE; SODIUM FLUORIDE 5; 2.43 mg/g; mg/g 11822-0822_cd85dae2-0747-4881-ad38-30d30cfcbc11 11822-0822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 19890815 OTC MONOGRAPH FINAL part347 Rite Aid WITCH HAZEL 86 kg/100L 11822-0823_82d65283-c713-4964-9820-7b41dc94118c 11822-0823 HUMAN OTC DRUG Triple Antibiotic Plus Maximum Strength bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hcl OINTMENT TOPICAL 20060601 OTC MONOGRAPH FINAL part333B Rite Aid BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 11822-0837_a1533d82-3b76-4f2c-9d0e-c7981be4f40d 11822-0837 HUMAN OTC DRUG acetaminophen pm Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20011002 OTC MONOGRAPH FINAL part338 Rite Aid Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 11822-0839_4e88101a-a48d-4ea0-aa96-00c19a2ff860 11822-0839 HUMAN OTC DRUG childrens mucus relief multi symptom cold dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20140604 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 11822-0843_953001ef-b856-4e8c-a680-5344a7aca828 11822-0843 HUMAN OTC DRUG hemorrhoidal relief Phenylephrine HCl, Witch hazel GEL TOPICAL 20140511 OTC MONOGRAPH FINAL part346 Rite Aid Corporation PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/100g; g/100g 11822-0850_b721e740-e60d-492e-86fd-f7b459b76d9c 11822-0850 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Rite Aid Corporation LORATADINE 5 mg/5mL 11822-0852_77253289-bed5-4c2e-b2ae-0fca71539cf8 11822-0852 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20090420 ANDA ANDA091429 Rite Aid Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 11822-0854_8837575b-6179-4f92-881b-f19120445ef7 11822-0854 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20071221 ANDA ANDA078546 Rite Aid Corporation NICOTINE 4 mg/1 11822-0866_03769180-6c9e-4d6c-ad0f-43aea9b9ad71 11822-0866 HUMAN OTC DRUG lice Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070725 OTC MONOGRAPH FINAL part358G Rite Aid Corporation PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL 11822-0871_0dd8f423-71f4-4e42-9bb1-60df101c9977 11822-0871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19930111 OTC MONOGRAPH NOT FINAL part333A Rite Aid HYDROGEN PEROXIDE .3 kg/100L 11822-0873_b03b1e13-ff16-41d9-82ce-7f5e83c11296 11822-0873 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20060224 ANDA ANDA077007 Rite Aid Corporation NICOTINE 4 mg/1 11822-0880_eb7e9bcb-03a4-42de-b3f7-df579077e58c 11822-0880 HUMAN OTC DRUG antacid extra strength Aluminum hydroxide, Magnesium carbonate TABLET, CHEWABLE ORAL 19970807 OTC MONOGRAPH FINAL part331 Rite Aid Corporation ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 11822-0897_3cb1bacb-1d20-49a8-8e78-3eaf782c7ce7 11822-0897 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990108 ANDA ANDA074937 Rite Aid Corporation IBUPROFEN 100 mg/5mL 11822-0899_6b5e9199-6eda-4984-9c99-8e080c58aaae 11822-0899 HUMAN OTC DRUG Enteric Safety Coated Aspirin Aspirin TABLET, COATED ORAL 20040114 OTC MONOGRAPH NOT FINAL part343 Rite Aid ASPIRIN 81 mg/1 11822-0900_547e8fa4-33e3-4dd2-8e92-e5095e52e03d 11822-0900 HUMAN OTC DRUG Rite Aid Pharmacy congestion relief vaporizing steam Vaporizing steam LIQUID RESPIRATORY (INHALATION) 20141001 OTC MONOGRAPH FINAL part341 Rite Aid Pharmacy CAMPHOR (SYNTHETIC) 6.2 g/118mL 11822-0902_339f3548-ca75-46ab-a628-718f9114c69b 11822-0902 HUMAN OTC DRUG Isopropyl Alcohol 70 percent Isopropyl Alcohol LIQUID TOPICAL 20090722 OTC MONOGRAPH FINAL part333 Rite Aid ISOPROPYL ALCOHOL 70 mL/100mL 11822-0909_f31b7899-2bfc-4b5d-93d9-0f5c0766c3f9 11822-0909 HUMAN OTC DRUG Ethyl Rubbing Alcohol ALCOHOL LIQUID TOPICAL 20090722 OTC MONOGRAPH FINAL part333 Rite Aid ALCOHOL 70 mL/100mL 11822-0912_59c75bb5-255c-4b55-a542-3f7cdebb4873 11822-0912 HUMAN OTC DRUG menstrual pain relief Maximum strength Acetaminophen, Pamabrom and Pyrilamine maleate TABLET, FILM COATED ORAL 20000620 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 11822-0915_c5d68e50-536e-46aa-8747-08b256402cfa 11822-0915 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080225 NDA NDA022032 Rite Aid Corporation OMEPRAZOLE 20 mg/1 11822-0916_ed2a381e-8ff4-4805-88fb-1b64735e6c27 11822-0916 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100616 ANDA ANDA079114 Rite Aid Corporation 11822-0923_453da4d5-7701-4452-87e8-f77f49e80ba6 11822-0923 HUMAN OTC DRUG eye itch relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20101006 ANDA ANDA077958 Rite Aid Corporation KETOTIFEN FUMARATE .25 mg/mL 11822-0944_b377a485-4594-4f60-98da-ff283ed6c23c 11822-0944 HUMAN OTC DRUG Hemorrhoidal Relief glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20080605 OTC MONOGRAPH FINAL part346 Rite Aid Corporation GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g 11822-0950_4784c5b2-58eb-4b7c-b6e9-13dde7610a37 11822-0950 HUMAN OTC DRUG cool mint acid reducer Ranitidine TABLET, FILM COATED ORAL 20111207 ANDA ANDA091429 Rite Aid Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 11822-0957_dbf9b647-ded0-4156-8dd4-c6c0bb7f08c0 11822-0957 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20130119 ANDA ANDA203690 Rite Aid Corporation NICOTINE 4 mg/1 11822-0958_8b13b4b3-7c00-4b09-b40e-0256431e28a7 11822-0958 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130724 ANDA ANDA091135 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 11822-0973_ded31186-224c-4c9b-a464-0d40f9176b0e 11822-0973 HUMAN OTC DRUG hydrocortisone 1 plus 10 hydrocortisone CREAM TOPICAL 20110216 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation HYDROCORTISONE 1 g/100g 11822-0974_c0043f89-607f-4c6e-a59f-abfc3ed9447f 11822-0974 HUMAN OTC DRUG childrens allergy relief cetirizine hydrochloride LIQUID ORAL 20080417 ANDA ANDA090254 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL 11822-0977_b2c0e27d-bad1-4da2-9873-20c750c9bd88 11822-0977 HUMAN OTC DRUG nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20120907 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 11822-0982_c2f5ba9d-bece-4617-8544-b1a071a2b725 11822-0982 HUMAN OTC DRUG Miconazole 3 miconazole nitrate KIT 20060818 ANDA ANDA076357 Rite Aid Corporation 11822-0990_1a599169-5c7e-4043-93af-d27adef358e7 11822-0990 HUMAN OTC DRUG nose Phenylephrine hydrochloride SOLUTION/ DROPS NASAL 19890815 OTC MONOGRAPH FINAL part341 Rite Aid Corporation PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 11822-0994_94500e3c-972b-408c-947c-5051bb91c2b9 11822-0994 HUMAN OTC DRUG cold and flu relief daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20120907 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 11822-0999_a02d32b9-edf9-44e2-9319-0d2d7eb180e5 11822-0999 HUMAN OTC DRUG Anti Wrinkle Ensulizole, Octinoxate CREAM TOPICAL 20090508 OTC MONOGRAPH NOT FINAL part352 Rite Aid Corporation ENSULIZOLE; OCTINOXATE 1; 6 g/100g; g/100g 11822-1000_09184b06-a315-4c74-abb4-3811a71c6a88 11822-1000 HUMAN OTC DRUG Rite Aid Instant Hand Sanitizer With Moisturizers ALCOHOL GEL TOPICAL 20091210 OTC MONOGRAPH NOT FINAL part333 Rite Aid Corporation ALCOHOL 62 mL/100mL 11822-1031_c03558fb-184a-40c8-91c5-9b664abfacb4 11822-1031 HUMAN OTC DRUG Rite Aid Baby Care Benzocaine GEL, DENTIFRICE ORAL 20110120 OTC MONOGRAPH FINAL part333B Rite Aid BENZOCAINE 7.5 g/100g 11822-1105_a531ac7d-3f4e-4945-97b2-db1b2eb8c4c9 11822-1105 HUMAN OTC DRUG First Aid Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 20060616 OTC MONOGRAPH FINAL part333B Rite Aid BACITRACIN ZINC 500 [USP'U]/g 11822-1110_3b874e01-dbfb-460d-bcfb-52be8e4819dd 11822-1110 HUMAN OTC DRUG Rite Aid antifungal ringworm Clotrimazole CREAM TOPICAL 19950601 OTC MONOGRAPH FINAL part333C Rite Aid Corporation CLOTRIMAZOLE 1 g/100g 11822-1120_94f41f72-9a0a-441c-9207-b53f6470dbd5 11822-1120 HUMAN OTC DRUG RITE AID RENEWAL PEAR TRICLOSAN LIQUID TOPICAL 20130325 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN 4.6 mg/mL 11822-1130_c755d71b-9431-4fd0-85cf-cd00d14fe61a 11822-1130 HUMAN OTC DRUG RITE AID RENEWAL WHITE TEA TRICLOSAN LIQUID TOPICAL 20130325 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN 4.6 mg/mL 11822-1261_d68bc745-eb99-475f-94df-a49f165398e7 11822-1261 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20080320 ANDA ANDA074916 Rite Aid IBUPROFEN 100 mg/5mL 11822-1403_14754cbb-8e9f-4515-bb30-3f7bc14a0438 11822-1403 HUMAN OTC DRUG Night Time Cherry Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090730 OTC MONOGRAPH FINAL part341 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 11822-1403_15169280-f98a-4170-b944-1a8373f603d0 11822-1403 HUMAN OTC DRUG Night Time Cherry Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090730 OTC MONOGRAPH FINAL part341 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 11822-1406_4ded2935-3487-4f36-a6f8-da7dc1cde9b7 11822-1406 HUMAN OTC DRUG Night Time Original Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090520 OTC MONOGRAPH FINAL part341 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 11822-1406_e002a8b5-ba16-44b2-b830-01b8b62dc9bc 11822-1406 HUMAN OTC DRUG Night Time Original Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090520 OTC MONOGRAPH FINAL part341 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 11822-1417_8c95f6b6-3e81-4749-b5bf-1274b109dadf 11822-1417 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20090730 OTC MONOGRAPH FINAL part341 Rite Aid DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 11822-1434_a16e1c6c-c655-4cfe-8612-2e11df757d1f 11822-1434 HUMAN OTC DRUG Childrens Plus Multi-Symptom Cold Grape with PE ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE SUSPENSION ORAL 20090811 OTC MONOGRAPH FINAL part341 Rite Aid ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 11822-1590_e58feea6-0eec-4c7d-97d2-e1929ad24ad2 11822-1590 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 11822-1645_6e3b358f-7a82-4186-ac07-d2c674bd1d6e 11822-1645 HUMAN OTC DRUG loperamide hydrochloride loperamide HCl LIQUID ORAL 20120523 ANDA ANDA091292 Rite Aid Corporation LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 11822-1683_dafaa2be-a718-449a-98a3-38df3e82e469 11822-1683 HUMAN OTC DRUG Rite Aid Foaming Hand TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN .6 mL/100mL 11822-1770_b1a2b8cb-f071-4bc0-b931-e1f6d6b6e7c4 11822-1770 HUMAN OTC DRUG RITE AID RENEWAL ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20130325 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN 4.6 mg/mL 11822-1773_e5a62e8d-bca1-4399-a8b7-15bbc1be44d5 11822-1773 HUMAN OTC DRUG RITE AID RENEWAL ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN .46 mg/100mL 11822-1793_9f287aa6-4b99-4400-9bb7-ba4bfca7ec4b 11822-1793 HUMAN OTC DRUG RITE AID RENEWAL TRICLOSAN LIQUID TOPICAL 20130418 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN 4.6 mg/mL 11822-1880_252a7345-2df4-433f-91db-58c7c92601bc 11822-1880 HUMAN OTC DRUG RITE AID RENEWAL WHITE TEA TRICLOSAN LIQUID TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN 4.6 mg/mL 11822-2004_9ec736b2-dc43-4338-8110-4b27c4d1a5cc 11822-2004 HUMAN OTC DRUG Childrens Allergy Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine HCI LIQUID ORAL 20090904 OTC MONOGRAPH FINAL part341 Rite Aid DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 11822-2092_d23a822a-dccf-4193-a79a-06154f3476de 11822-2092 HUMAN OTC DRUG Childrens Allergy Relief Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Rite Aid Corporation LORATADINE 5 mg/5mL 11822-2099_28a0ccfa-cecd-400d-8312-72339069e235 11822-2099 HUMAN OTC DRUG Rite Aid anti-itch Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation HYDROCORTISONE 1 g/100g 11822-2102_91d6ab05-f0f4-4779-839e-9c2fc2529709 11822-2102 HUMAN OTC DRUG Rite Aid childrens allergy relief Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL 11822-2104_aeee82ae-d544-4bfa-822b-2fc9b1bf9ed3 11822-2104 HUMAN OTC DRUG Flu Relief Therapy Day Time Acetaminophen, Dextromethorphan Hydrobromide,Phenylephrine Hydrochloride LIQUID ORAL 20090904 OTC MONOGRAPH FINAL part341 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 11822-2106_7e15962f-0507-4474-9504-6fc6c59312b1 11822-2106 HUMAN OTC DRUG Rite Aid childrens allergy relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE 1 mg/mL 11822-2108_4810a985-a9e8-4d09-937d-6d03c966cae7 11822-2108 HUMAN OTC DRUG RENEWAL TRICLOSAN LIQUID TOPICAL 20110318 OTC MONOGRAPH NOT FINAL part333E RITE AID TRICLOSAN .115 L/100L 11822-2112_cd692a85-6e69-4dc5-9c5f-8b2c94282e85 11822-2112 HUMAN OTC DRUG Rite Aid Daytime Severe Cold and Cough Relief Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 11822-2113_7f0dbcaa-36a9-4fbd-b283-06241985c70f 11822-2113 HUMAN OTC DRUG Rite Aid Nighttime Severe Cold and Cough Relief Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 11822-2160_4b11bec0-6514-40da-a00d-9c36846b373c 11822-2160 HUMAN OTC DRUG RITE AID RENEWAL ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20121221 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN 1.5 mg/mL 11822-2180_3211c944-b54c-4efe-b44d-870c7bb32b2c 11822-2180 HUMAN OTC DRUG Pain Relief Aspirin Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part356 Rite Aid ASPIRIN 81 mg/1 11822-2202_a501cb53-ee7e-4807-bfac-dead2a21a347 11822-2202 HUMAN OTC DRUG Rite Aid Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN .15 mL/100mL 11822-2203_34f0d519-af00-4f55-9079-85d407dcb762 11822-2203 HUMAN OTC DRUG Rite Aid Liquid TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN .15 mL/100mL 11822-2250_12524941-9597-4a6e-b4cb-4641815839ea 11822-2250 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 RITE AID CORPORATION ALCOHOL 62 mL/100mL 11822-2253_45920523-9754-4043-a665-613a4e7e2b17 11822-2253 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 RITE AID CORPORATION ALCOHOL 62 mL/100mL 11822-2350_2be2a631-b133-4a06-aa71-8e2a52d7e12c 11822-2350 HUMAN OTC DRUG Extra Strength Pain Relief PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 11822-2400_1a8640de-e2bb-48e5-b664-e0c157a2337d 11822-2400 HUMAN OTC DRUG Artificial Tears Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20100901 OTC MONOGRAPH FINAL part349 Rite Aid Corporation PROPYLENE GLYCOL .95 mL/100mL 11822-2461_af64b798-7ca5-4372-bb38-c1ba3ead7463 11822-2461 HUMAN OTC DRUG Renewal Eczema Moisturizing Colloidal Oatmeal CREAM TOPICAL 20131101 OTC MONOGRAPH FINAL part347 Rite Aid Corporation OATMEAL 1 g/100g 11822-2683_dce46afe-898a-47c9-b72e-2c76455af7f5 11822-2683 HUMAN OTC DRUG RITE AID RENEWAL MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL LIQUID TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION ALCOHOL 620 mg/mL 11822-2890_e8b22e2e-5f72-4520-b460-e5b423df3b3e 11822-2890 HUMAN OTC DRUG BENZOCAINE and RESORCINOL BENZOCAINE and RESORCINOL OINTMENT TOPICAL 20090519 OTC MONOGRAPH NOT FINAL part348 RiteAid BENZOCAINE; RESORCINOL 200; 20 mg/g; mg/g 11822-2891_eb64015e-ac53-45f0-8c60-97de3570ceaa 11822-2891 HUMAN OTC DRUG Rite Aid Original Strength Vagicaine BENZOCAINE and RESORCINOL CREAM TOPICAL 20100719 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation BENZOCAINE; RESORCINOL 50; 20 mg/g; mg/g 11822-2943_e0dd6a2b-5028-4f9e-8b7a-5b791ed73688 11822-2943 HUMAN OTC DRUG RITE AID RENEWAL ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN .15 mg/100mL 11822-3025_6867702f-c8e3-41cc-806e-4523c7a07543 11822-3025 HUMAN OTC DRUG Lubricant / Redness Reliever Naphazoline Hydrochloride and Hypromellose SOLUTION/ DROPS OPHTHALMIC 20100902 OTC MONOGRAPH FINAL part349 Rite Aid Corporation HYPROMELLOSES; NAPHAZOLINE HYDROCHLORIDE .3; 5 mg/mL; mg/mL 11822-3108_fe48c2cb-150d-449b-b0cb-4eea1d674d67 11822-3108 HUMAN OTC DRUG Oral Care Antiseptic Eucalyptol MOUTHWASH ORAL 19901015 OTC MONOGRAPH NOT FINAL part356 Rite Aid EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 mL/100L; mL/100L; mL/100L; mL/100L 11822-3201_43643537-8dfa-45d1-a1a3-a280e1465f8b 11822-3201 HUMAN OTC DRUG DAILY MOISTURIZING WITH NATURAL COLLOIDAL OATMEAL DIMETHICONE LOTION TOPICAL 20100625 OTC MONOGRAPH FINAL part347 RITE AID CORPORATION DIMETHICONE 1.25 mL/100mL 11822-3202_c02f699a-9e6c-4789-8fcf-db6c579a83b5 11822-3202 HUMAN OTC DRUG RITE AID RENEWAL DAILY MOISTURIZING DIMETHICONE LIQUID TOPICAL 20120925 OTC MONOGRAPH FINAL part347 RITE AID CORPORATION DIMETHICONE 12.5 mg/mL 11822-3207_98fddfdc-e289-4218-8cd7-a188eb8db88c 11822-3207 HUMAN OTC DRUG Renewal 7-in-1 Anti-Aging Vitamin Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120517 OTC MONOGRAPH NOT FINAL part352 Rite Aid Corporation AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 mL/100mL; mL/100mL; mL/100mL 11822-3215_1585a1ae-5be4-4e16-ad06-6b710bb5fedf 11822-3215 HUMAN OTC DRUG Original Redness Reliever Naphazoline Hydrochloride and Polyethylene glycol 300 SOLUTION/ DROPS OPHTHALMIC 20100913 OTC MONOGRAPH FINAL part349 Rite Aid Corporation NAPHAZOLINE HYDROCHLORIDE; POLYETHYLENE GLYCOL 300 .1; 2 mg/mL; mg/mL 11822-3271_96838b7f-aa9c-4ac3-ae87-065ae98f419a 11822-3271 HUMAN OTC DRUG Baby Care Vitamins A and D Lanolin OINTMENT TOPICAL 20140305 OTC MONOGRAPH FINAL part347 Rite Aid Corporation LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g 11822-3300_38a19499-c16a-41ce-b296-46d8e9294f74 11822-3300 HUMAN OTC DRUG HYDRATING HEALING DAILY THRAPY PETROLATUM OINTMENT TOPICAL 20100719 OTC MONOGRAPH FINAL part347 RITE AID PETROLATUM 41 g/100g 11822-3301_a4d67f13-8d9e-411e-a693-1539b240a4e0 11822-3301 HUMAN OTC DRUG HYDRATING HEALING DAILY THRAPY PETROLATUM OINTMENT TOPICAL 20100719 OTC MONOGRAPH FINAL part347 RITE AID PETROLATUM 41 g/100g 11822-3303_db573480-8363-4dfb-a968-d58c416f794a 11822-3303 HUMAN OTC DRUG RITE AID RENEWAL PETROLATUM JELLY TOPICAL 20121030 OTC MONOGRAPH FINAL part346 RITE AID CORPORATION PETROLATUM 410 mg/g 11822-3351_dd309d13-5798-415a-968c-845113bc3d6e 11822-3351 HUMAN OTC DRUG RENEWAL MEDICATED MENTHOL - DIMETHICONE LOTION TOPICAL 20100714 OTC MONOGRAPH FINAL part347 RITE AID DIMETHICONE; MENTHOL 5; .5 mL/100mL; mL/100mL 11822-3401_9cec1a5c-9771-4b6f-8594-c32a817d9f4a 11822-3401 HUMAN OTC DRUG VITAMINS A AND D DIAPER RASH LANOLIN AND PETROLATUM OINTMENT TOPICAL 20110104 OTC MONOGRAPH FINAL part346 RITE AID LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g 11822-3410_960eece5-bd7b-4185-9456-a84039f26e05 11822-3410 HUMAN OTC DRUG RITE AID RENEWAL SUNSCREEN ENSULIZOLE LOTION TOPICAL 20110721 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 2; 7.5; 7.5; 1.9 mL/100mL; mL/100mL; mL/100mL; mL/100mL 11822-3416_22aeb145-42fc-4e8f-8b9f-8c5ec8008a4a 11822-3416 HUMAN OTC DRUG Day Time with PE Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine HCI LIQUID ORAL 20090813 OTC MONOGRAPH FINAL part341 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 11822-3420_79d76f31-4786-4b95-b6ab-44aa525bcaff 11822-3420 HUMAN OTC DRUG RENEWAL DAILY MOISTURIZER SENSITIVE SKIN ZINCE OXIDE LOTION TOPICAL 20110721 OTC MONOGRAPH FINAL part346 RITE AID CORPORATION TITANIUM DIOXIDE; ZINC OXIDE 5; 3 mL/100mL; mL/100mL 11822-3540_54aa092c-b4c1-4a0e-bafa-a32af7090603 11822-3540 HUMAN OTC DRUG RITE AID RENEWAL ADVANCED HEALING PETROLATUM OINTMENT TOPICAL 20120622 OTC MONOGRAPH FINAL part346 RITE AID CORPORATION PETROLATUM 41 g/100g 11822-3541_b8b9119d-ed4d-4024-a433-e62dcfcc8b48 11822-3541 HUMAN OTC DRUG RITE AID RENEWAL HYDRATING PETROLATUM JELLY TOPICAL 20121015 OTC MONOGRAPH FINAL part346 RITE AID CORPORATION PETROLATUM 410 mg/g 11822-3601_0d9cc9ff-67dd-4055-8b94-7f39f2e24512 11822-3601 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20090416 OTC MONOGRAPH NOT FINAL part334 Rite Aid MINERAL OIL 15 mL/15mL 11822-3670_308b87dc-b844-4453-ae03-16296398f47e 11822-3670 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 Rite Aid DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 11822-3705_cbecb620-8988-4c64-a03c-c970f5eebaeb 11822-3705 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 19940104 OTC MONOGRAPH FINAL part355 Rite Aid SODIUM FLUORIDE .1 mg/mL 11822-3720_33954c1d-6c30-46be-b449-3b8bd8f5a6e9 11822-3720 HUMAN OTC DRUG Mucus Relief Plus Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20020727 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 11822-3724_e40e041a-e597-4566-8b6f-ddf20c9d28cf 11822-3724 HUMAN OTC DRUG Antiseptic Night Rinse Cetylpyridinium Chloride MOUTHWASH ORAL 20090317 OTC MONOGRAPH NOT FINAL part356 Rite Aid CETYLPYRIDINIUM CHLORIDE .07 kg/100L 11822-3729_aab88281-fec7-4336-bb06-748d5badeb7a 11822-3729 HUMAN OTC DRUG Rite Aid Cold and Hot Medicated Menthol PATCH TOPICAL 20100629 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation MENTHOL 50 g/1 11822-3801_d8b6127b-3fcd-4356-896e-616579c6e7a3 11822-3801 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090320 OTC MONOGRAPH FINAL part333 Rite Aid ISOPROPYL ALCOHOL 91 mL/100mL 11822-3865_7504beb9-aae7-4bac-9aa0-80fea3220877 11822-3865 HUMAN OTC DRUG Eye Allergy Relief Pheniramine Maleate and Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20100831 NDA NDA020065 Rite Aid Corporation NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL 11822-3904_65ca2c05-efa6-488c-a8c8-5c062f1f86af 11822-3904 HUMAN OTC DRUG Rite Aid Instant Hand Sanitizer ALCOHOL GEL TOPICAL 20091222 OTC MONOGRAPH NOT FINAL part333 Rite Aid Corporation ALCOHOL 62 mL/100mL 11822-3950_0273d979-c311-44e0-a2a7-16d1f27ff44e 11822-3950 HUMAN OTC DRUG Rite Aid Liquid Anesthetic Oral Pain Relief BENZOCAINE GEL ORAL 20100708 OTC MONOGRAPH FINAL part356 Rite Aid Corporation BENZOCAINE 200 mg/mL 11822-3957_04deebef-abbf-4f24-9f8a-dbafe87835e8 11822-3957 HUMAN OTC DRUG Alcohol Swabs with Benzocaine benzocaine SWAB TOPICAL 20090701 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 11822-4070_1e8e18be-e648-4a46-ac8c-db0ee614de9d 11822-4070 HUMAN OTC DRUG Rite Aid Cold Sore Treatment Camphor CREAM TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Rite Aid BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g 11822-4073_82a0d4bc-887e-407b-913f-f18aafe81642 11822-4073 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090819 OTC MONOGRAPH FINAL part333 Rite Aid ISOPROPYL ALCOHOL 70 mL/100mL 11822-4101_324f90ad-2a4b-4757-b616-aa233856d205 11822-4101 HUMAN OTC DRUG Rite Aid Dandruff 2 in 1 Classic Clean Pyrithione Zinc SHAMPOO TOPICAL 20101020 OTC MONOGRAPH FINAL part358H Rite Aid Corporation PYRITHIONE ZINC 1 mL/100mL 11822-4111_8942402b-330a-4cb3-90e0-c06b66e3c39f 11822-4111 HUMAN OTC DRUG Rite Aid Dandruff 2 in 1 Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20101020 OTC MONOGRAPH FINAL part358H Rite Aid Corporation PYRITHIONE ZINC 1 mL/100mL 11822-4141_e18d2755-3500-43d2-a85a-11ecafc8abd2 11822-4141 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090826 OTC MONOGRAPH NOT FINAL part356 Rite Aid HYDROGEN PEROXIDE 2.65 mL/100mL 11822-4201_492a183a-8adf-4a13-85a5-b35d533d4f25 11822-4201 HUMAN OTC DRUG eye itch relief ketotifen fumarate SOLUTION/ DROPS OPHTHALMIC 20131206 ANDA ANDA077958 Rite Aid Corporation KETOTIFEN FUMARATE .35 mg/mL 11822-4202_7ae76b30-68ff-4263-818e-a5d0b48935cb 11822-4202 HUMAN OTC DRUG eye itch relief ketotifen fumarate SOLUTION/ DROPS OPHTHALMIC 20131206 ANDA ANDA077958 Rite Aid Corporation KETOTIFEN FUMARATE .35 mg/mL 11822-4500_b45076fc-e095-498e-8ae1-6a709c01d377 11822-4500 HUMAN OTC DRUG RENEWAL ANTI-DANDRUFF SALICYLIC ACID LIQUID TOPICAL 20141208 OTC MONOGRAPH FINAL part333D RITE AID CORPORATION SALICYLIC ACID 20 mg/mL 11822-4530_abd47b1d-801a-4b29-879d-2824ceae4c80 11822-4530 HUMAN OTC DRUG Maximum Strength Sinus Pressure and Congestion Relief PE Phenylephrine HCl TABLET, COATED ORAL 20040616 OTC MONOGRAPH FINAL part341 Rite Aid PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 11822-4591_1b19148a-3d2c-4d1d-b808-3fc39a31f0b7 11822-4591 HUMAN OTC DRUG Renewal Anti-Wrinkle Avobenzone and Octocrylene CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Rite Aid Corporation AVOBENZONE; OCTOCRYLENE 3; 10 g/100g; g/100g 11822-4600_78de47e7-39fb-4df4-8d6b-f66030642424 11822-4600 HUMAN OTC DRUG CVS fast relief laxative Bisacodyl Suppository SUPPOSITORY RECTAL 20141001 OTC MONOGRAPH NOT FINAL part334 Rite Aid Pharmacy BISACODYL 10 mg/2000mg 11822-4601_7ebccf12-c18a-4192-9035-f7daa38f42dd 11822-4601 HUMAN OTC DRUG CVS fast relief laxative Bisacodyl Suppository SUPPOSITORY RECTAL 20141002 OTC MONOGRAPH NOT FINAL part334 Rite Aid Pharmacy BISACODYL 10 mg/2000mg 11822-4650_95d28594-88c9-419c-9ab0-395dd8a938bd 11822-4650 HUMAN OTC DRUG PURE SPRING ETHYL ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E RITE AID ALCOHOL 62 mL/100mL 11822-4660_3b1951e6-dd62-478f-872c-0ed6de227620 11822-4660 HUMAN OTC DRUG PURE SPRING STRAWBERRY AND POMEGRANATE ETHYL ALCOHOL LIQUID TOPICAL 20120319 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION ALCOHOL 62 mL/100mL 11822-4670_b0b21a3d-876a-41f1-917d-29c1694640a7 11822-4670 HUMAN OTC DRUG PURE SPRING LEMON AND MINT ETHYL ALCOHOL LIQUID TOPICAL 20120319 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION ALCOHOL 62 mL/100mL 11822-4803_9ac7058d-96bd-41c5-9db9-181b66432370 11822-4803 HUMAN OTC DRUG RITE AID RENEWAL WITH MOISTURIZERS ETHYL ALCOHOL LIQUID TOPICAL 20120318 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION ALCOHOL 700 mg/mL 11822-5020_2c7f8a0f-0635-40db-b6c8-b8c53f157005 11822-5020 HUMAN OTC DRUG Rite Aid Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20130603 OTC MONOGRAPH NOT FINAL part356 Rite Aid POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 11822-5022_8d997f8d-8a35-4708-a19f-6700afc6b38f 11822-5022 HUMAN OTC DRUG Maximum Strength Sinus Pressure and Pain PE Acetaminophen and Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 11822-5156_3ea9112f-7de0-4876-a45b-7e4696a586f8 11822-5156 HUMAN OTC DRUG Alcohol Isopropyl alcohol SWAB TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part333A Rite Aid Corporation ISOPROPYL ALCOHOL 70 mL/100mL 11822-5161_3a7dbdef-7ea2-4b64-8e69-96e37514486c 11822-5161 HUMAN OTC DRUG Renewal Hydrating Healing Petrolatum OINTMENT TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Rite Aid PETROLATUM 41 g/100g 11822-5250_42863c6e-d5e2-4b11-94d4-98a47672b671 11822-5250 HUMAN OTC DRUG cold and allergy relief Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20020722 OTC MONOGRAPH FINAL part341 Rite Aid CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 11822-5260_198ca9b7-030b-434e-864b-3b91024f573c 11822-5260 HUMAN OTC DRUG severe cold and sinus relief PE Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET, FILM COATED ORAL 20050621 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 11822-5311_2fc0d6ac-b201-4cc2-8a07-27fdea9cf47e 11822-5311 HUMAN OTC DRUG Extra Strength pain relief Acetaminophen TABLET ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN 500 mg/1 11822-5330_3bfc54b7-f68f-4ec0-b322-a2412203ebb3 11822-5330 HUMAN OTC DRUG Mucus Relief Cough and Congestion DM Guaifenesin and Dextromethorphan HBr TABLET, COATED ORAL 20051231 OTC MONOGRAPH FINAL part341 Rite Aid DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 11822-5334_f5de129f-7994-427c-b85e-083989e93a2f 11822-5334 HUMAN OTC DRUG Rite Aid Oral Pain Reliever Benzocaine LIQUID ORAL 20130801 OTC MONOGRAPH FINAL part333B Rite Aid BENZOCAINE 20 g/100g 11822-5340_73013a3e-1e42-4b7e-9e07-f48ad26dfefa 11822-5340 HUMAN OTC DRUG Rite Aid Professional Strength Benzocaine LIQUID ORAL 20140101 OTC MONOGRAPH FINAL part333B Rite Aid BENZOCAINE 20 g/100g 11822-5458_ac81ca1f-9c8a-4f77-ba49-9c139bbfb048 11822-5458 HUMAN OTC DRUG Sodium Chloride Sodium Chloride SOLUTION/ DROPS OPHTHALMIC 20130221 OTC MONOGRAPH FINAL part349 Rite Aid Corporation SODIUM CHLORIDE 50 mg/mL 11822-5567_eea645f3-fb7d-4b04-9924-0045605939e5 11822-5567 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20131226 OTC MONOGRAPH FINAL part355 Rite Aid SODIUM FLUORIDE .1 mg/mL 11822-5648_60e69586-86a8-4640-a5e1-f1de80e16439 11822-5648 HUMAN OTC DRUG Rite Aid Extra Strength Pain Relief Cold and Hot Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Rite Aid MENTHOL 750 mg/1 11822-5649_2e636405-0db7-4985-8774-eef63369667e 11822-5649 HUMAN OTC DRUG Rite Aid Extra Strength Pain Relief Cold and Hot Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Rite Aid MENTHOL 750 mg/1 11822-5744_3953ad5a-6712-4377-9af0-2a6358790909 11822-5744 HUMAN OTC DRUG RITE AID CAPSICUM HOT CAPSAICIN PATCH TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part348 RITE AID CORPORATION CAPSAICIN .6 mg/1 11822-6010_78429032-6cde-4e0a-99c4-e46eae1bab36 11822-6010 HUMAN OTC DRUG RITE AID DAILY MOISTURIZER SPF 15 AVOBENZONE LOTION TOPICAL 20100804 OTC MONOGRAPH FINAL part352 Rite Aid Corporation AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 2 mL/100mL; mL/100mL; mL/100mL 11822-6020_dc2b802d-7583-47ee-96ec-b505c8185c6e 11822-6020 HUMAN OTC DRUG Rite Aid Enamel Guard Fluoride PASTE, DENTIFRICE DENTAL 20130603 OTC MONOGRAPH NOT FINAL part356 Rite Aid POTASSIUM NITRITE; SODIUM FLUORIDE 5; .15 g/100g; g/100g 11822-6030_129aaffe-a682-466a-965d-1fabd55d7532 11822-6030 HUMAN OTC DRUG Rite Aid Maximum Strength Benzocaine PASTE, DENTIFRICE TOPICAL 20110120 OTC MONOGRAPH FINAL part333B Rite Aid BENZOCAINE 20 g/100g 11822-6101_1917fd42-dd64-4a68-b321-b673641ba13e 11822-6101 HUMAN OTC DRUG Rite Aid MEDICATED DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20100929 OTC MONOGRAPH FINAL part358H Rite Aid Corporation SELENIUM SULFIDE 1 mL/100mL 11822-6111_116402f7-4b54-4c22-8a44-159b613bb9f7 11822-6111 HUMAN OTC DRUG Rite Aid Moisturizing Dandruff Medicated Formula Selenium Sulfide SHAMPOO TOPICAL 20120320 OTC MONOGRAPH FINAL part358H Rite Aid Corporation SELENIUM SULFIDE 1 mL/100mL 11822-6150_5e866c30-5628-4baf-ac40-70ef0c6cb753 11822-6150 HUMAN OTC DRUG Maximum Strength Mucus Relief Cold and SInus Max Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET ORAL 20130407 OTC MONOGRAPH FINAL part341 Rite Aid ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 11822-6160_b7c8655d-5481-49c7-9faf-1adbd7b89b81 11822-6160 HUMAN OTC DRUG Maximum Strength Mucus Relief Cold Flu and Sore Throat Max Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 OTC MONOGRAPH FINAL part341 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 11822-6181_5a0c253c-a39f-46e0-a7be-65bec449a4a3 11822-6181 HUMAN OTC DRUG RITE AID RENEWAL CLINICAL SELENIUM SULFIDE LIQUID TOPICAL 20130326 OTC MONOGRAPH FINAL part358H RITE AID CORPORATION SELENIUM SULFIDE 10 mg/mL 11822-6190_34b25178-384d-4f91-8af5-6e3b1a36ae62 11822-6190 HUMAN OTC DRUG Non-Prescription Strength Acid Reducer Ranitidine TABLET ORAL 20130615 ANDA ANDA200536 Rite Aid RANITIDINE HYDROCHLORIDE 75 mg/1 11822-6201_344d4216-82a8-4e87-adde-d2972cc481e9 11822-6201 HUMAN OTC DRUG RITE AID RENEWAL MEDICATED SELENIUM SULFIDE LIQUID TOPICAL 20130715 OTC MONOGRAPH FINAL part358H RITE AID CORPORATION SELENIUM SULFIDE 10 mg/mL 11822-6211_ff89aadc-d3ad-4982-9f21-6d1b6472eec3 11822-6211 HUMAN OTC DRUG RITE AID RENEWAL SELENIUM SULFIDE LIQUID TOPICAL 20130620 OTC MONOGRAPH FINAL part358H RITE AID CORPORATION SELENIUM SULFIDE 10 mg/mL 11822-6280_b9089a8c-2937-4ddf-a5de-506b1386fd93 11822-6280 HUMAN OTC DRUG sinus pressure and pain maximum strength acetaminophen, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20130503 OTC MONOGRAPH FINAL part341 Rite Aid ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 11822-7001_5d9e1b7b-2bc1-41c9-b03f-451d116c27e2 11822-7001 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20111014 OTC MONOGRAPH FINAL part333D Rite Aid SALICYLIC ACID 19.8 mg/g 11822-7200_b55a01bb-f9f6-41be-8e02-9dac2a8c8040 11822-7200 HUMAN OTC DRUG Rite Aid Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN .115 mL/100mL 11822-7206_949a4330-515d-4f90-889d-3681e199d0d3 11822-7206 HUMAN OTC DRUG Rite Aid Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN .115 mL/100mL 11822-7208_d76245a5-9e4c-43fb-a3e8-480b32b2a732 11822-7208 HUMAN OTC DRUG RITE AID TRICLOSAN LIQUID TOPICAL 20120221 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN .115 mL/100mL 11822-7250_c7d6e723-1c99-4a30-a2c4-b4a57a8fbca6 11822-7250 HUMAN OTC DRUG Childrens Allergy Relief Fexofenadine Hydrochloride SUSPENSION ORAL 20141219 ANDA ANDA203330 Rite Aid FEXOFENADINE HYDROCHLORIDE 30 mg/5mL 11822-7310_d7863725-02de-4768-bd02-843c4a6aff95 11822-7310 HUMAN OTC DRUG Miconazole 3 Combination Pack Miconazole Nitrate KIT 20010301 ANDA ANDA074926 Rite Aid 11822-7463_fca5b078-8c59-4b66-802a-101dcb3c160f 11822-7463 HUMAN OTC DRUG Alcohol Isopropyl alcohol SWAB TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part333A Rite Aid Corporation ISOPROPYL ALCOHOL 70 mL/100mL 11822-8010_663a3218-8034-47d2-9f5d-e3deb093f0e7 11822-8010 HUMAN OTC DRUG RITE AID RENEWAL ANTIBACTERIAL CLEAR SPRING TRICLOSAN LIQUID TOPICAL 20120925 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN 1.5 mg/mL 11822-8011_d342c1a7-1353-45c8-83e3-b5ad875aea0d 11822-8011 HUMAN OTC DRUG Body Wash Clear Spring Triclosan SOAP TOPICAL 20100922 OTC MONOGRAPH NOT FINAL part333E Rite Aid Corporation TRICLOSAN .15 mL/100mL 11822-8071_b510a182-c672-46dd-aa93-5171c3344df5 11822-8071 HUMAN OTC DRUG RITE AID RENEWAL CLEAR SPRING TRICLOSAN LIQUID TOPICAL 20130702 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN 1.5 mg/mL 11822-8200_b4339c3f-c0db-4d06-9e3d-30b0be59834a 11822-8200 HUMAN OTC DRUG RENEWAL SALICYLIC ACID CREAM TOPICAL 20110728 OTC MONOGRAPH FINAL part333D RITE AID CORPORATION SALICYLIC ACID 2 mL/100mL 11822-8210_6860f233-ca92-4867-a484-3b854ba92a45 11822-8210 HUMAN OTC DRUG RITE AID RENEWAL SALICYLIC ACID CREAM TOPICAL 20110803 OTC MONOGRAPH FINAL part333D RITE AID CORPORATION SALICYLIC ACID 2 mL/100mL 11822-8220_cad17a81-d559-49b5-a0f5-c3f85c68ddae 11822-8220 HUMAN OTC DRUG First Aid Antibiotic Pain Relief Maximum Strength Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20061002 OTC MONOGRAPH NOT FINAL part347 Rite Aid NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 11822-8270_b7fe9bdd-4111-42f3-b1e2-0de3a28f409b 11822-8270 HUMAN OTC DRUG RITE AID RENEWAL ACNE SALICYLIC ACID LIQUID TOPICAL 20120607 OTC MONOGRAPH FINAL part333D RITE AID SALICYLIC ACID 2 mL/100mL 11822-8271_a8272cdf-665e-4e94-87b6-2a128b950510 11822-8271 HUMAN OTC DRUG Quick Relief Creamy Diaper Rash Zinc Oxide CREAM TOPICAL 20140305 OTC MONOGRAPH FINAL part347 Rite Aid Corporation ZINC OXIDE 13 g/100g 11822-8453_aee02c3a-3bdc-47cf-a3f4-b86f5408b82c 11822-8453 HUMAN OTC DRUG Rite Aid Renewal Gold Deodorant Triclocarban SOAP TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part333A Rite Aid Corporation TRICLOCARBAN .3 g/g 11822-8787_c146226d-3636-4451-a313-1b4123a93770 11822-8787 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130828 OTC MONOGRAPH NOT FINAL part356 Rite Aid EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 11822-9000_82805791-9260-470e-b5f5-cd55c8145338 11822-9000 HUMAN OTC DRUG Rite Aid Sport SunscreenSPF 30 SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g 11822-9001_e14cf041-7cbc-45e4-bf14-2888078edad5 11822-9001 HUMAN OTC DRUG Rite Aid Sport SunscreenSPF 50 SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g 11822-9002_1c674517-16f4-4a90-90e3-a569d882acc3 11822-9002 HUMAN OTC DRUG Rite Aid Ear Drops Chamomilla and Mercurius solubilis and Sulphur SOLUTION AURICULAR (OTIC) 20060101 UNAPPROVED HOMEOPATHIC Rite Aid Corporation CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR 10; 15; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 11822-9003_965186b9-706c-4e7b-bfbe-d3d70cc36d16 11822-9003 HUMAN OTC DRUG Rite Aid Oil Free Faces Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 8; 5; 5; 4 g/100g; g/100g; g/100g; g/100g; g/100g 11822-9004_9e4000c0-f6b5-4cc0-9ba1-3b8d2017b1aa 11822-9004 HUMAN OTC DRUG Rite Aid Essential Defense SPF 45 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 12; 7.5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g 11822-9005_b34d203b-cfe3-4113-8f35-4f0a8d26cf61 11822-9005 HUMAN OTC DRUG Rite Aid Sunscreen SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 11822-9006_3041da46-b8ea-40f3-81e8-c55a51eb772b 11822-9006 HUMAN OTC DRUG Rite Aid Dark Tanning SPF 4 OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION OCTOCRYLENE; OXYBENZONE 1; .5 g/100g; g/100g 11822-9007_17de2183-c966-42c5-99ad-2f8a82e9521f 11822-9007 HUMAN OTC DRUG Rite Aid Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g 11822-9008_d39b177f-ef26-4ada-9531-1db9272df8d8 11822-9008 HUMAN OTC DRUG Rite Aid Kids Sunscreen SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE SPRAY TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g 11822-9009_df855d59-886e-4d63-a749-a94d8279b610 11822-9009 HUMAN OTC DRUG Rite Aid Burn Relief LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part348 RITE AID CORPORATION LIDOCAINE HYDROCHLORIDE .5 g/100g 11822-9010_870c8bee-fc44-48c6-b397-886194d11fa2 11822-9010 HUMAN OTC DRUG Rite Aid Baby Sunscreen AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 11822-9011_b0f7005b-6635-4c7a-bf25-41ac35393f2f 11822-9011 HUMAN OTC DRUG Rite Aid Sunscreen AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g 11822-9012_93cb5423-b074-42d2-a425-f8390d2e258c 11822-9012 HUMAN OTC DRUG Rite Aid Ultimate Sheer AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.8; 6 g/100g; g/100g; g/100g; g/100g; g/100g 11822-9013_77e38e12-fa60-4f08-b2e4-95733794ac09 11822-9013 HUMAN OTC DRUG Rite Aid Ultimate Sheer AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2.8; 6 g/100g; g/100g; g/100g; g/100g; g/100g 11822-9014_8939cd6b-5f18-44dd-9429-b130d196add0 11822-9014 HUMAN OTC DRUG Rite Aid Sunscreen OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20121205 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 6 g/100g; g/100g; g/100g 11822-9015_5463dfe3-8865-4e03-a0e9-09a8f82e47db 11822-9015 HUMAN OTC DRUG Rite Aid Sport Sunscreen AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121207 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 8; 4 g/100g; g/100g; g/100g 11822-9016_f76595c9-9fe1-45f3-aa83-d91884e11c88 11822-9016 HUMAN OTC DRUG Rite Aid Ultimate Sheer AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 4.5; 6 g/100g; g/100g; g/100g; g/100g; g/100g 11822-9017_c2c25ee8-8c96-4648-b1ef-58c9325b956a 11822-9017 HUMAN OTC DRUG Rite Aid RENEWAL Sport SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g 11822-9018_a788a651-540b-4ad7-bbc5-298ce688d862 11822-9018 HUMAN OTC DRUG Rite Aid RENEWALSPF 50 SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g 11822-9019_adebfb64-7a9f-414f-b551-ce38e5bcf7fe 11822-9019 HUMAN OTC DRUG Rite Aid RENEWAL oil free faces AVOBENZONE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 5; 3 g/100g; g/100g; g/100g 11822-9020_0c864434-31c6-4e4a-accc-e6717c3b0f9a 11822-9020 HUMAN OTC DRUG Rite Aid RENEWAL essential defense SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 11822-9021_c240aff0-5ec3-4f40-a722-174b69c48fe0 11822-9021 HUMAN OTC DRUG Rite Aid RENEWAL SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g 11822-9022_01a9a5e5-b1e8-4c5c-988c-6852dc0f80ca 11822-9022 HUMAN OTC DRUG Rite Aid RENEWAL kids SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 11822-9023_89451c8d-0e06-468b-9d20-4c4ba6cc2b27 11822-9023 HUMAN OTC DRUG Rite Aid RENEWAL SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g 11822-9025_3cb7dcd4-9619-4a5d-bcf2-b6cd896e69eb 11822-9025 HUMAN OTC DRUG Rite Aid RENEWAL SPF 30 AVOBENZONE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 5; 3 g/100g; g/100g; g/100g 11822-9026_ef641492-b860-4175-8536-5fdd0ae3e940 11822-9026 HUMAN OTC DRUG Rite Aid RENEWAL SPF 50 AVOBENZONE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 4; 6 g/100g; g/100g; g/100g 11822-9027_37c20b60-857c-4337-925f-d890795f6ffb 11822-9027 HUMAN OTC DRUG Rite Aid RENEWAL baby sunscreen SPF 60 TITANIUM DIOXIDE ZINC OXIDE LOTION TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION TITANIUM DIOXIDE; ZINC OXIDE 2.8; 4 g/100g; g/100g 11822-9271_69660bdd-6a57-40e9-9dfd-d4ea6020b9a0 11822-9271 HUMAN OTC DRUG Maximum Strength Original Diaper Rash Zinc Oxide CREAM TOPICAL 20140305 OTC MONOGRAPH FINAL part347 Rite Aid Corporation ZINC OXIDE 40 g/100g 11822-9650_dfd95b82-aebf-49ec-b0e0-0da34ec2ada5 11822-9650 HUMAN OTC DRUG RIte Aid Maximum Strength Foot Care Anti-fungal Pen Undecylenic Acid LIQUID TOPICAL 20131210 OTC MONOGRAPH FINAL part333C Rite Aid UNDECYLENIC ACID 250 mg/mL 11822-9785_40701bec-d348-446d-be4f-728ed3981f8b 11822-9785 HUMAN OTC DRUG Advanced Firming and Anti Wrinkle Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120517 OTC MONOGRAPH NOT FINAL part352 Rite Aid Corporation AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 5 g/100g; g/100g; g/100g 11822-9854_48cef92e-4cbc-4b79-a7fe-1f071945cc9c 11822-9854 HUMAN OTC DRUG Artifical Tears Glycerin and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20100901 OTC MONOGRAPH FINAL part349 Rite Aid Corporation GLYCERIN; PROPYLENE GLYCOL .3; 1 g/100mL; g/100mL 11822-9860_b0114d22-a48d-4c6c-b384-aeecfd4d8bb7 11822-9860 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20100831 OTC MONOGRAPH FINAL part349 Rite Aid Corporation WATER 99.05 mL/100mL 11853-013_9f685625-2ba7-45e5-a05a-3f825b5b5c96 11853-013 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205737 Air Liquide Large Industries U.S. LP OXYGEN 99 L/100L 11853-023_16a7311e-2b3e-45e6-81c0-e8e1fafbe5f3 11853-023 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205738 Air Liquide Large Industries U.S. LP NITROGEN 99 L/100L 11868-311_a00f7802-f281-4381-a699-8aacb51d49c1 11868-311 HUMAN OTC DRUG Cold Preparation Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Monticello Drug LLC (New Genesis) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 11896-0017_b1216615-78a2-4377-add6-957fd7c781cc 11896-0017 HUMAN PRESCRIPTION DRUG Helium Oxygen Helium Oxygen GAS RESPIRATORY (INHALATION) 19640101 UNAPPROVED MEDICAL GAS Airgas National Welders HELIUM; OXYGEN 800; 200 mL/L; min/L 11896-0018_51e6cf36-97ae-4d17-9372-5a3947c2e0bb 11896-0018 HUMAN PRESCRIPTION DRUG Helium Oxygen Helium Oxygen GAS RESPIRATORY (INHALATION) 19640101 UNAPPROVED MEDICAL GAS Airgas National Welders HELIUM; OXYGEN 700; 300 mL/L; mL/L 11896-0019_e0ed0937-63ba-409e-a194-6b45ebef5ed6 11896-0019 HUMAN PRESCRIPTION DRUG Helium Oxygen Helium Oxygen GAS RESPIRATORY (INHALATION) 19640101 UNAPPROVED MEDICAL GAS Airgas National Welders HELIUM; OXYGEN 600; 400 mL/L; mL/L 11917-023_34cfdbe8-d13e-456a-a3de-903d4abb4e76 11917-023 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205713 Air Liquide Industrial U.S. LP NITROGEN 99 L/100L 11928-003_b4ed83ff-78b3-41f1-ab08-394fb4857e06 11928-003 HUMAN OTC DRUG MADA Hand Sanitizing Wipes Alcohol LIQUID TOPICAL 20100405 OTC MONOGRAPH NOT FINAL part333 Mada Medical Products, Inc. ALCOHOL 65 mL/100mL 11928-682_a3baee18-524b-47f7-a8c3-f904793cbba5 11928-682 HUMAN OTC DRUG Mada Medical Foam Sanitizer Benzethonium Chloride LIQUID TOPICAL 20100102 OTC MONOGRAPH NOT FINAL part333A Mada Medical BENZETHONIUM CHLORIDE .2 mL/100mL 11960-0045_ed47d536-da3d-4083-8bef-c81a1c73fabc 11960-0045 HUMAN OTC DRUG Cramergesic menthol, methyl salicylate OINTMENT TOPICAL 19920715 OTC MONOGRAPH NOT FINAL part348 Cramer Products Inc MENTHOL; METHYL SALICYLATE .019; .137 g/g; g/g 11960-0049_c18ced39-4afc-4073-b1e7-47363df948ed 11960-0049 HUMAN OTC DRUG Nitrotan isopropyl alcohol, benzyl alcohol, picric acid, tannic acid AEROSOL, SPRAY TOPICAL 19920715 OTC MONOGRAPH NOT FINAL part333A Cramer Products Inc BENZYL ALCOHOL; ISOPROPYL ALCOHOL; PICRIC ACID; TANNIC ACID .061; .62; .002; .015 g/g; g/g; g/g; g/g 11960-0550_8f8bc748-6344-4356-b6e2-4b6e82ce7d84 11960-0550 HUMAN OTC DRUG ISO-QUIN Alcohol GEL TOPICAL 20000614 OTC MONOGRAPH NOT FINAL part333E Cramer Products, Inc ALCOHOL .68 mL/mL 11960-1201_500a5d33-4a33-4ddf-8ce6-123e670ae590 11960-1201 HUMAN OTC DRUG Coachs First Aid Contains 102 Pieces BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN KIT 20100502 OTC MONOGRAPH FINAL part333 Cramer Sports 11980-011_c90cb2dd-aa2f-4070-b4bb-38e16359b438 11980-011 HUMAN PRESCRIPTION DRUG BLEPH-10 sulfacetamide sodium SOLUTION/ DROPS OPHTHALMIC 19710601 NDA NDA080028 Allergan, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 11980-022_64d32a4e-ad4b-413a-a775-41e8c854bfc5 11980-022 HUMAN PRESCRIPTION DRUG BLEPHAMIDE sulfacetamide sodium and prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19611001 NDA NDA012813 Allergan, Inc. PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM 2; 100 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 11980-174_97aa4882-30ae-4b81-981c-3e9ad500f02c 11980-174 HUMAN PRESCRIPTION DRUG PRED MILD prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19721201 NDA NDA017100 Allergan, Inc. PREDNISOLONE ACETATE 1.2 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 11980-180_17930688-83e2-47e7-93f2-c2f15bcff50a 11980-180 HUMAN PRESCRIPTION DRUG PRED FORTE prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19730601 NDA NDA017011 Allergan, Inc. PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 11980-211_d839481e-c5e5-442b-85f7-c634d50b97b9 11980-211 HUMAN PRESCRIPTION DRUG FML fluorometholone SUSPENSION/ DROPS OPHTHALMIC 19720201 NDA NDA016851 Allergan, Inc. FLUOROMETHOLONE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 11980-228_86169620-8649-4b2d-aa5f-b7ab057f489b 11980-228 HUMAN PRESCRIPTION DRUG FML FORTE fluorometholone SUSPENSION/ DROPS OPHTHALMIC 19860501 NDA NDA019216 Allergan, Inc. FLUOROMETHOLONE 2.5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 11980-779_c3b5609c-3d6a-4c9a-8f81-611d0fa19180 11980-779 HUMAN PRESCRIPTION DRUG OCUFLOX ofloxacin SOLUTION/ DROPS OPHTHALMIC 19930801 NDA NDA019921 Allergan, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 11980-801_e41e9af7-b6ef-4c26-bbe9-5ea9e31f45c8 11980-801 HUMAN PRESCRIPTION DRUG OCUFEN flurbiprofen sodium SOLUTION/ DROPS OPHTHALMIC 19870101 NDA NDA019404 Allergan, Inc. FLURBIPROFEN SODIUM .3 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 11994-001_352380a1-a352-45eb-ba2d-3502bd8e051b 11994-001 HUMAN PRESCRIPTION DRUG Cardiolite TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19901220 NDA NDA019785 Lantheus Medical Imaging, Inc. TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1 mg/mL 11994-003_a17bc7c1-9b20-42f8-bd06-7c39a53de06f 11994-003 HUMAN PRESCRIPTION DRUG Kit for the Preparation of Technetium Tc99m Sestamibi TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19901220 NDA NDA019785 Lantheus Medical Imaging, Inc. TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1 mg/mL 11994-006_fcf17545-a671-4ae3-8148-af38dfa0184c 11994-006 HUMAN PRESCRIPTION DRUG NEUROLITE Bicisate dihydrochloride KIT INTRAVENOUS 19941123 NDA NDA020256 Lantheus Medical Imaging, Inc. 11994-011_85004bfb-dea0-41a4-8cef-dc1e76b3b1f0 11994-011 HUMAN PRESCRIPTION DRUG Definity perflutren INJECTION, SUSPENSION INTRAVENOUS 20010731 NDA NDA021064 Lantheus Medical Imaging, Inc. PERFLUTREN 6.52 mg/mL Contrast Agent for Ultrasound Imaging [EPC],Ultrasound Contrast Activity [MoA] 11994-012_e4c9f857-324d-49ad-a126-5755f69c414c 11994-012 HUMAN PRESCRIPTION DRUG Ablavar Gadofosveset trisodium INJECTION, SOLUTION INTRAVENOUS 20081212 NDA NDA021711 Lantheus Medical Imaging, Inc. GADOFOSVESET TRISODIUM 244 mg/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] 11994-015_69b2d2fe-9837-4421-89c6-c4196eb28f17 11994-015 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F-18 Fludeoxyglucose F-18 INJECTION INTRAVENOUS 20140204 ANDA ANDA203664 Lantheus Medical Imaging, Inc. FLUDEOXYGLUCOSE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 11994-016_22b7d40e-5f65-4541-8cce-7d600738bb9e 11994-016 HUMAN PRESCRIPTION DRUG Quadramet Samarium SM 153 Lexidronam INJECTION, SOLUTION INTRAVENOUS 19970519 NDA NDA020570 Lantheus Medical Imaging, Inc. SAMARIUM SM-153 LEXIDRONAM PENTASODIUM 50 mCi/mL 11994-090_513b5882-7196-4bdc-84b1-68dde44f7968 11994-090 HUMAN PRESCRIPTION DRUG TechneLite Technetium Tc99m Generator INJECTION, SOLUTION INTRAVENOUS 19751101 NDA NDA017771 Lantheus Medical Imaging, Inc. TECHNETIUM TC-99M SODIUM PERTECHNETATE 250 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 11994-121_96bce1f0-1255-460e-8839-46d494411921 11994-121 HUMAN PRESCRIPTION DRUG Gallium GALLIUM CITRATE GA-67 INJECTION INTRAVENOUS 19760519 NDA NDA017478 Lantheus Medical Imaging, Inc. GALLIUM CITRATE GA-67 2 mCi/mL 11994-127_5e08a0cc-8002-4c3b-8635-78cd95346411 11994-127 HUMAN PRESCRIPTION DRUG Xenon Xenon XE-133 GAS RESPIRATORY (INHALATION) 19741010 NDA NDA017284 Lantheus Medical Imaging, Inc. XENON XE-133 10 mCi/1 Inhalation Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 11994-128_5e08a0cc-8002-4c3b-8635-78cd95346411 11994-128 HUMAN PRESCRIPTION DRUG Xenon Xenon XE-133 GAS RESPIRATORY (INHALATION) 19741010 NDA NDA017284 Lantheus Medical Imaging, Inc. XENON XE-133 20 mCi/1 Inhalation Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 11994-427_d7457aff-9687-4570-a5dc-120b34bc9686 11994-427 HUMAN PRESCRIPTION DRUG Thallous Chloride Tl 201 THALLOUS CHLORIDE TL-201 INJECTION, SOLUTION INTRAVENOUS 19771219 NDA NDA017806 Lantheus Medical Imaging, Inc. THALLOUS CHLORIDE TL-201 2 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 11999-001_d1883ae2-5480-4a3e-b224-a59c22a7c8ea 11999-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19730101 UNAPPROVED MEDICAL GAS Welders Supply Company OXYGEN 992 mL/L 11999-002_6d588532-72ee-41d4-a304-ef33333af1f7 11999-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19730101 UNAPPROVED MEDICAL GAS Welders Supply Company NITROGEN 990 mL/L 12022-240_69b95e75-a6e6-4750-a4aa-461d508a7e13 12022-240 HUMAN OTC DRUG GENERATIONS NADINOLA DAY TIME PROTECTING MOISTURIZER SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20121129 OTC MONOGRAPH FINAL part352 J. Strickland & Co. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 5; 2.8 g/100g; g/100g; g/100g; g/100g 12027-100_5e6388f9-b66f-422b-b90e-5529dae7c68e 12027-100 HUMAN OTC DRUG wet n wild megashield OCTINOXATE OXYBENZONE LIPSTICK TOPICAL 20111201 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 12027-101_f0e754d4-49d2-40d1-b31b-59f3eca75102 12027-101 HUMAN OTC DRUG wet n wild juicy lip balm Octinoxate Octocrylene Oxybenzone LIPSTICK TOPICAL 20111201 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc OCTINOXATE; OCTOCRYLENE; OXYBENZONE 7.5; 7; 2 g/100g; g/100g; g/100g 12027-102_a3085dad-4a66-4505-9f09-0030441a6dfe 12027-102 HUMAN OTC DRUG wet n wild Ultimate Match OCTINOXATE OXYBENZONE LIQUID TOPICAL 20111201 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc OCTINOXATE; OXYBENZONE 6; 2 mL/100mL; mL/100mL 12027-103_134664ad-3aed-4b22-8bed-3acc3b685030 12027-103 HUMAN OTC DRUG wet n wild coloricon bronzer OCTINOXATE OXYBENZONE POWDER TOPICAL 20111201 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc OCTINOXATE; OXYBENZONE 5; 1.5 g/100g; g/100g 12027-104_16cf7f06-07f8-49c6-95a6-0a660a770d53 12027-104 HUMAN OTC DRUG wet n wild Ultimate Sheer OCTINOXATE OXYBENZONE LIQUID TOPICAL 20111201 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc OCTINOXATE; OXYBENZONE 6; 2 mL/100mL; mL/100mL 12027-105_8ff3825c-aef3-4cef-a3fb-969cdbc9b71a 12027-105 HUMAN OTC DRUG Wet n Wild Fergie BB Cream SPF 15 Titanium Dioxide CREAM TOPICAL 20130531 OTC MONOGRAPH NOT FINAL part352 Markwins Beauty Products Inc. TITANIUM DIOXIDE 3.8 g/100mL 12027-106_23f3d9a0-53cb-4c09-a575-28882775b556 12027-106 HUMAN OTC DRUG Black Radiance True Complexion BB Cream SPF 15 HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20130913 OTC MONOGRAPH NOT FINAL part352 Markwins Beauty Products Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE 4; 2; 3 g/100mL; g/100mL; g/100mL 12090-0015_c861b4d6-30aa-4c71-88a2-b9ae0e094e0f 12090-0015 HUMAN OTC DRUG Creomulsion For Children DEXTROMETHORPHAN HYDROBROMIDE SYRUP ORAL 20091230 OTC MONOGRAPH NOT FINAL part341 Summit Industries, Inc. DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL 12090-0016_7b7da226-297a-4f44-aa94-fdf34d64a9da 12090-0016 HUMAN OTC DRUG Lantiseptic Dry Skin Therapy LANOLIN CREAM TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part347 Summit Industries, Inc. LANOLIN 370 mg/g 12090-0019_a25a6658-8dc8-4493-93bf-85aeff479299 12090-0019 HUMAN OTC DRUG Lantiseptic Skin Protectant LANOLIN CREAM TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part347 Summit Industries, Inc. LANOLIN 500 mg/g 12090-0024_a019d113-fe49-4a1c-8b17-2944d2dca214 12090-0024 HUMAN OTC DRUG Creomulsion Cough Medicine Adult Formula DEXTROMETHORPHAN HYDROBROMIDE SYRUP ORAL 20091230 OTC MONOGRAPH NOT FINAL part341 Summit Industries, Inc. DEXTROMETHORPHAN HYDROBROMIDE 20 mg/15mL 12090-0032_cee1e77a-d865-40e7-9809-3f6438c59704 12090-0032 HUMAN OTC DRUG Lantiseptic Multi-Purpose MENTHOL, CALAMINE, ZINC OXIDE OINTMENT TOPICAL 20091230 OTC MONOGRAPH FINAL part347 Summit Industries, Inc. FERRIC OXIDE RED; MENTHOL; ZINC OXIDE 20; 4.5; 180 mg/g; mg/g; mg/g 12090-0040_93a317f8-b434-446f-922e-cfd69c7680a5 12090-0040 HUMAN OTC DRUG Lantiseptic Daily Care Skin Protectant LANOLIN OINTMENT TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part347 Summit Industries, Inc. LANOLIN 300 mg/g 12090-0042_597f599d-ec66-429f-b765-6be4f1b650b2 12090-0042 HUMAN OTC DRUG LanoGuard Dry Skin Therapy LANOLIN CREAM TOPICAL 20091230 OTC MONOGRAPH FINAL part347 Summit Industries, Inc. LANOLIN 370 mg/g 12090-0061_0c61edf7-96f9-4f42-9b8a-ea6c95daa8b8 12090-0061 HUMAN OTC DRUG Lanoguard Multi-Purpose MENTHOL, CALAMINE, ZINC OXIDE OINTMENT TOPICAL 20130321 OTC MONOGRAPH FINAL part347 Summit Industries, Inc. FERRIC OXIDE RED; MENTHOL; ZINC OXIDE 20; 4.5; 180 mg/g; mg/g; mg/g 12090-0074_d47db560-6292-483f-9705-b2cf8f05efab 12090-0074 HUMAN OTC DRUG LanoGuard Daily Care Skin Protectant LANOLIN OINTMENT TOPICAL 20130321 OTC MONOGRAPH FINAL part347 Summit Industries, Inc. LANOLIN 300 mg/g 12090-1235_8c9b0715-099a-4faf-965a-3dde55290322 12090-1235 HUMAN OTC DRUG Boroleum for Nasal Soreness CAMPHOR, MENTHOL, WHITE PETROLATUM OINTMENT TOPICAL 20101210 OTC MONOGRAPH FINAL part347 Summit Industries CAMPHOR (SYNTHETIC); MENTHOL; PETROLATUM 10; 5.4; 979.2 mg/g; mg/g; mg/g 12121-001_63172449-4b5a-4c13-9a79-7955a141744f 12121-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19550101 NDA NDA205767 Badger Welding Supplies, Inc OXYGEN 99 L/100L 12121-002_cdd5bd0a-4097-4788-b1a5-068e369b0845 12121-002 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19550101 NDA NDA205704 Badger Welding Supplies, Inc NITROUS OXIDE 99 L/100L 12121-006_c5cb7eb8-10a5-468c-81d9-c2af006531b3 12121-006 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19550101 NDA NDA205766 Badger Welding Supplies, Inc NITROGEN 99 L/100L 12213-005_cb388e1d-9157-41d5-bc06-89cf74934cf7 12213-005 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19960601 UNAPPROVED MEDICAL GAS NexAir, LLC CARBON DIOXIDE 991 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 12213-498_901dc16a-86f0-4a5e-9ccd-237e8e8f1963 12213-498 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19960601 UNAPPROVED MEDICAL GAS NexAir, LLC NITROGEN 990 mL/L 12213-593_7ca40345-4dbe-4b8b-abea-bffe41ce7bdd 12213-593 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19960601 UNAPPROVED MEDICAL GAS NexAir, LLC NITROUS OXIDE 990 mL/L 12213-700_5a5778bc-d396-47e3-9975-8b0eb74c9101 12213-700 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19960601 NDA NDA205859 NexAir, LLC AIR 1000 mL/L 12213-710_0d08e01f-7a02-4a4e-bb95-a17257805c0a 12213-710 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19960601 UNAPPROVED MEDICAL GAS NexAir, LLC HELIUM 999 mL/L 12213-720_70c27bbd-21f4-4b59-b069-ee9a696d8ed8 12213-720 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19960601 UNAPPROVED MEDICAL GAS NexAir, LLC OXYGEN 991 mL/L 12213-730_0d52a197-c92c-4c2f-8d9b-7678cd5bf433 12213-730 HUMAN PRESCRIPTION DRUG Helium Oxygen Mix Helium Oxygen Mix GAS RESPIRATORY (INHALATION) 19960601 UNAPPROVED MEDICAL GAS NexAir, LLC HELIUM; OXYGEN 800; 200 mL/L; mL/L 12213-731_1ed92bc1-b380-4a75-9152-c810cc337a00 12213-731 HUMAN PRESCRIPTION DRUG Nitrogen Oxygen Mix Nitrogen Oxygen Mix GAS RESPIRATORY (INHALATION) 19960601 UNAPPROVED MEDICAL GAS NexAir, LLC NITROGEN; OXYGEN 790; 210 mL/L; mL/L 12258-223_8bef575b-3ae0-41e0-beb2-7769f3ed8cfe 12258-223 HUMAN OTC DRUG Curasore Pramoxine Hydrochloride LIQUID TOPICAL 19950831 OTC MONOGRAPH FINAL part346 S.S.S. Company PRAMOXINE HYDROCHLORIDE 1 g/100mL 12258-241_2a15a176-7f7a-4d2c-b9a1-fbbd1175abac 12258-241 HUMAN OTC DRUG Green Tetterine Miconazole Nitrate OINTMENT TOPICAL 19940731 OTC MONOGRAPH FINAL part333C S.S.S. Company MICONAZOLE NITRATE 2 g/100g 12258-242_c2dc8551-c4cb-462a-9e9f-11a49f916cfc 12258-242 HUMAN OTC DRUG White Tetterine Miconazole Nitrate OINTMENT TOPICAL 19950228 OTC MONOGRAPH FINAL part333C S.S.S. Company MICONAZOLE NITRATE 2 g/100g 12462-200_e208072e-8dea-4821-b316-d0949c110e94 12462-200 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333 Chester Packaging, LLC HYDROGEN PEROXIDE 3 mL/100mL 12462-201_7963b73e-2365-4d9f-87bc-6a4990a8ff2b 12462-201 HUMAN OTC DRUG gent-L-tip sodium phosphate ENEMA RECTAL 20110103 OTC MONOGRAPH NOT FINAL part334 Chester Packaging SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 12462-250_890c35de-97b2-4cce-83d0-c2a8c9ec5d45 12462-250 HUMAN OTC DRUG AprilFresh Roll-On Anti-Perspirant Deoderant Aluminum Chlorohydrate LIQUID TOPICAL 20090101 OTC MONOGRAPH FINAL part350 Chester Packaging, LLC ALUMINUM CHLOROHYDRATE 10 mL/100mL 12462-300_fe4d521a-a488-4d34-b9f8-9fc5542528f8 12462-300 HUMAN OTC DRUG System TLC Anti-dandruff Pyrithione Zinc SHAMPOO TOPICAL 20050101 OTC MONOGRAPH FINAL part358H Chester Packaging, LLC PYRITHIONE ZINC 1 mg/100mL 12462-301_0dd9d83f-b7ac-451b-a02b-5494a9ec170d 12462-301 HUMAN OTC DRUG gent-L-tip mineral oil ENEMA RECTAL 20110103 OTC MONOGRAPH NOT FINAL part334 Chester Packaging MINERAL OIL 118 mL/118mL 12462-400_e10ae459-3092-4b6d-9dcc-94d782461be0 12462-400 HUMAN OTC DRUG Antimicrobial Triclosan SOAP TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333 Chester Packaging, LLC TRICLOSAN .3 mg/100mL 12462-501_3ff8ddfc-9928-4d98-a5a1-fccb1abdd06c 12462-501 HUMAN OTC DRUG Pacific Garden Antibacterial Foam Soothing Lavender Triclosan SOAP TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333 Chester Packaging LLC TRICLOSAN .3 mg/100mL 12462-502_102d634e-7d12-42d5-a16d-0f5385a778df 12462-502 HUMAN OTC DRUG Antibacterial Foam with Moisturizers Triclosan SOAP TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333 Chester Packaging, LLC TRICLOSAN .3 mg/100mL 12462-503_087ddb90-72db-4e59-8051-8078f59b5226 12462-503 HUMAN OTC DRUG Antibacterial Liquid Energizing Citrus Triclosan SOAP TOPICAL 20060901 OTC MONOGRAPH NOT FINAL part333 Chester Packaging, LLC TRICLOSAN .3 mg/100mL 12462-504_4765fb98-0c7d-4d73-88e3-6db96b4a1d37 12462-504 HUMAN OTC DRUG Antibacterial Foam Energizing Citrus Triclosan SOAP TOPICAL 20060901 OTC MONOGRAPH NOT FINAL part333 Chester Packaging, LLC TRICLOSAN .3 mg/100mL 12462-600_7eb97d2a-73a1-4303-b14c-be10e363a539 12462-600 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20060201 OTC MONOGRAPH NOT FINAL part333 Chester Packaging, LLC ALCOHOL 62 mL/100mL 12462-601_ccc84ec2-b832-4d40-bf7a-85b76ccaac7b 12462-601 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20020901 OTC MONOGRAPH NOT FINAL part333 Chester Packaging, LLC ALCOHOL 62 mL/100mL 12462-603_ddf8b9da-7e9d-4116-a93f-d7162306d388 12462-603 HUMAN OTC DRUG AprilGuard Antiseptic Handrub Ethyl Alcohol AEROSOL, FOAM TOPICAL 20050601 OTC MONOGRAPH NOT FINAL part333E Chester Packaging, LLC ALCOHOL 62 g/100g 12462-606_834f21a4-2b24-4080-ae1a-e263b25bda9d 12462-606 HUMAN OTC DRUG Sanitizing Alcohol Rub Ethyl Alcohol LOTION TOPICAL 20090701 OTC MONOGRAPH NOT FINAL part333 Chester Packaging, LLC ALCOHOL 62 mL/100mL 12462-700_d65d00ec-4a80-472c-8e88-2c1e054f6912 12462-700 HUMAN OTC DRUG Antimicrobial Soap Chloroxylenol SOAP TOPICAL 20030101 OTC MONOGRAPH NOT FINAL part333 Chester Packaging, LLC CHLOROXYLENOL .3 mg/100mL 12462-701_12b5e1e2-5879-4c71-8bfa-af7b385ba446 12462-701 HUMAN OTC DRUG Food Processing Chloroxylenol SOAP TOPICAL 20060201 OTC MONOGRAPH NOT FINAL part333 Chester Packaging, LLC CHLOROXYLENOL 2 g/100L 12462-938_825f6f3d-3b29-4fad-8bde-79b19ccf2370 12462-938 HUMAN OTC DRUG PVP Scrub Povidone-Iodine SOLUTION TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part333A Chester Packaging, LLC POVIDONE-IODINE 7.5 mL/100mL 12462-939_04ad8e14-f9b3-4742-9b04-5737d86ca2d6 12462-939 HUMAN OTC DRUG PVP Prep Povidone-Iodine SOLUTION TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part333A Chester Packaging, LLC POVIDONE-IODINE 10 mL/100mL 12488-0100_3bf5c112-24ca-4ecd-b479-8aff193427c7 12488-0100 HUMAN OTC DRUG St. Ives Blemish and Blackhead Control salicylic acid EMULSION TOPICAL 20090601 OTC MONOGRAPH FINAL part333D Alberto Culver USA Inc. SALICYLIC ACID .02 g/g 12488-0200_cd125513-f13b-4ccf-aa0d-f304d79964a0 12488-0200 HUMAN OTC DRUG St. Ives Blemish and Blackhead Facial Salicylic Acid SOAP TOPICAL 20090601 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .02 mL/mL 12488-0300_b7674d93-a6bb-44ab-a234-e4c743565cf0 12488-0300 HUMAN OTC DRUG St. Ives Naturally Clear Green Tea Facial Salicylic Acid SOAP TOPICAL 20100131 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .01 mL/mL 12488-0400_488df815-5438-42ad-9ff7-7efec1b767d2 12488-0400 HUMAN OTC DRUG St. Ives Naturally Clear Green Tea Facial Salicylic Acid SOAP TOPICAL 20100131 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .02 mL/mL 12488-0500_3f4f4eb1-0893-48d3-976b-2a87f35ef053 12488-0500 HUMAN OTC DRUG ST. IVES BODY SCRUB NATURALLY CLEAR SKIN GREEN TEA Salicylic Acid EMULSION TOPICAL 20110214 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .02 mL/mL 12488-0600_a87e2ede-d0ec-408f-bcf0-ae3fc949b269 12488-0600 HUMAN OTC DRUG ST. IVES BODY WASH NATURALLY CLEAR SKIN GREEN TEA Salicylic Acid SOAP TOPICAL 20110214 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .02 mL/mL 12488-0700_b2a9c916-0244-4fc5-8569-b2aeb7eade7c 12488-0700 HUMAN OTC DRUG ST. IVES NATURALLY CLEAR SKIN GREEN TEA FACIAL Salicylic Acid SOAP TOPICAL 20120101 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .02 g/g 12488-1000_0f4cc7e8-4cb6-430e-afb4-9f4cb6e4a742 12488-1000 HUMAN OTC DRUG Noxzema Triple Clean Triclosan SOAP TOPICAL 20090601 OTC MONOGRAPH FINAL part333 Alberto-Culver USA Inc. TRICLOSAN .003 g/g 12488-1100_c9527f3e-b936-4d90-b925-5f3c9824f332 12488-1100 HUMAN OTC DRUG Noxzema Triple Clean Salicylic Acid CLOTH TOPICAL 20090601 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .02 g/g 12488-1200_344434e7-000a-4c61-9dbf-c95a77f2f308 12488-1200 HUMAN OTC DRUG Noxzema Salicyclic Acid SOAP TOPICAL 20100101 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .01 g/g 12488-1300_bb7e45f6-0697-456a-adf1-6b275cc8e512 12488-1300 HUMAN OTC DRUG Noxzema Salicyclic Acid SOAP TOPICAL 20100101 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .01 mL/mL 12488-1800_aba16eab-dfe7-4370-bf7a-43059ccccf0d 12488-1800 HUMAN OTC DRUG Nu Skin Epoch Alcohol GEL TOPICAL 20090601 OTC MONOGRAPH FINAL part333 Alberto-Culver USA Inc. ALCOHOL 61.9937 mL/100mL 12488-2000_ba74ffda-eafa-4d17-838e-c2f4af85227b 12488-2000 HUMAN OTC DRUG Simple Vital Vitamin Day SPF 15 Homosalate, Octisalate, Avobenzone, and Octocrylene EMULSION TOPICAL 20120101 OTC MONOGRAPH FINAL part352 Alberto-Culver USA Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .03; .12; .05; .027 g/g; g/g; g/g; g/g 12496-0757_82328aaa-bdc0-4622-a8dc-ac328a5883e8 12496-0757 HUMAN PRESCRIPTION DRUG Buprenex buprenorphine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19850630 NDA NDA018401 Reckitt Benckiser Pharmaceuticals Inc BUPRENORPHINE HYDROCHLORIDE .3 mg/mL Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 12496-1202_0aad3594-f74b-4c61-ab49-173161de88fa 12496-1202 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride, naloxone hydrochloride FILM, SOLUBLE SUBLINGUAL 20100913 NDA NDA022410 Reckitt Benckiser Pharmaceuticals Inc BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 12496-1204_0aad3594-f74b-4c61-ab49-173161de88fa 12496-1204 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride, naloxone hydrochloride FILM, SOLUBLE SUBLINGUAL 20120824 NDA NDA022410 Reckitt Benckiser Pharmaceuticals Inc BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 4; 1 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 12496-1208_0aad3594-f74b-4c61-ab49-173161de88fa 12496-1208 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride, naloxone hydrochloride FILM, SOLUBLE SUBLINGUAL 20100913 NDA NDA022410 Reckitt Benckiser Pharmaceuticals Inc BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 12496-1212_0aad3594-f74b-4c61-ab49-173161de88fa 12496-1212 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride, naloxone hydrochloride FILM, SOLUBLE SUBLINGUAL 20120824 NDA NDA022410 Reckitt Benckiser Pharmaceuticals Inc BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 12; 3 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 12516-0592_4057b792-ee8b-46ad-a497-9691e43d362b 12516-0592 HUMAN PRESCRIPTION DRUG ELOXATIN oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090722 NDA NDA021759 Aventis Pharma Ltd. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 12546-101_179a5151-4619-4d39-a760-1038113b52f8 12546-101 HUMAN OTC DRUG Halls Ice Peppermint Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondel?z Global LLC MENTHOL 10 mg/1 12546-103_d016b1cf-b08a-488a-829a-4d999c4def6e 12546-103 HUMAN OTC DRUG Halls Sugar Free Black Cherry Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondel?z Global LLC MENTHOL 6.6 mg/1 12546-104_52119ca6-ca00-4a3b-8731-6913d4852627 12546-104 HUMAN OTC DRUG Halls Sugar Free Black Cherry Menthol LOZENGE ORAL 20110727 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5.8 mg/1 12546-105_b6da0e76-e3b4-4a7e-bbfe-807b0cd1caa3 12546-105 HUMAN OTC DRUG Halls Mocha Mint Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5 mg/1 12546-106_5244bae0-f702-40ee-9fc8-77db41ecf51f 12546-106 HUMAN OTC DRUG Halls Apple Cider Menthol LOZENGE ORAL 20130723 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5.7 mg/1 12546-107_2483f468-67d6-49d9-bd46-7b1902908f1f 12546-107 HUMAN OTC DRUG Halls Sugar Free Black Cherry Menthol LOZENGE ORAL 20110701 OTC MONOGRAPH FINAL part341 Kraft Foods Global, Inc. MENTHOL 3.7 mg/1 12546-108_9fec7127-f1bc-445c-a0a9-77cedd87f185 12546-108 HUMAN OTC DRUG Halls Butterscotch Menthol LOZENGE ORAL 20111201 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5 mg/1 12546-109_7474a61d-81b7-4a71-8052-a2e1bd0df84b 12546-109 HUMAN OTC DRUG Halls Cherry Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5.8 mg/1 12546-110_734f19bf-1a19-458a-bf21-e4b29ab781ae 12546-110 HUMAN OTC DRUG Halls Honey Lemon Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 7.5 mg/1 12546-111_c88c7a3a-d2c8-440c-a33e-bdd9ba60ed4d 12546-111 HUMAN OTC DRUG Halls Ice Peppermint Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 8.2 mg/1 12546-112_8db5f0e7-e164-4ad6-ba67-27c078b3b405 12546-112 HUMAN OTC DRUG Halls MENTHO-LYPTUS Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5.4 mg/1 12546-113_98b09e12-a2de-47a1-8f38-73cec2068265 12546-113 HUMAN OTC DRUG Halls Spearmint Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 4.6 mg/1 12546-114_6c5c699f-d8aa-47e1-af31-b40b49131ae9 12546-114 HUMAN OTC DRUG Halls Strawberry Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 2.7 mg/1 12546-115_52d64b6f-0182-4b67-8c14-3c16ba828ff6 12546-115 HUMAN OTC DRUG Halls Tropical Fruit Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 2.7 mg/1 12546-151_4ed01579-3006-4577-b01e-b419123f29f1 12546-151 HUMAN OTC DRUG Breezers Cool Berry Pectin LOZENGE ORAL 20130807 OTC MONOGRAPH NOT FINAL part356 Mondelez Global LLC PECTIN 7 mg/1 12546-164_013d99af-b4f0-448c-b9cc-38d6df91de93 12546-164 HUMAN OTC DRUG Halls Mentholyptus Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondel?z Global LLC MENTHOL 6.5 mg/1 12546-165_96108f36-1a5f-4981-84d4-67bbd72f8015 12546-165 HUMAN OTC DRUG Halls Cherry Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondel?z Global LLC MENTHOL 7 mg/1 12546-191_02b58b42-7277-4fc4-afd7-fd49038a5409 12546-191 HUMAN OTC DRUG Halls Spearmint Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondel?z Global LLC MENTHOL 5.6 mg/1 12546-219_339c6f4f-5cc2-4b24-9906-0b5386e81451 12546-219 HUMAN OTC DRUG Halls Strawberry Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 3.2 mg/1 12546-223_da0de187-4d97-4d1c-ae54-e3ae2a91fd43 12546-223 HUMAN OTC DRUG Halls Sugar Free Honey Berry Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 2.5 mg/1 12546-224_b55c3f43-cb87-47ff-966b-17aacfd5d273 12546-224 HUMAN OTC DRUG Halls Naturals Honey Lemon Chamomile Menthol LOZENGE ORAL 20130807 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 2.5 mg/1 12546-310_2da2575b-bdfe-4419-ae95-4eb0a0cfc0e3 12546-310 HUMAN OTC DRUG Halls Honey Lemon Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondel?z Global LLC MENTHOL 9.1 mg/1 12546-311_bbbfb376-dcf3-4ed3-a726-1c3e4c533c1f 12546-311 HUMAN OTC DRUG Halls Extra Strong Menthol Menthol LOZENGE ORAL 20130501 OTC MONOGRAPH NOT FINAL part356 Mondel?z Group LLC MENTHOL 15 mg/1 12546-313_72dbb8d3-94fc-4315-9573-b114ba409c4c 12546-313 HUMAN OTC DRUG Halls Sugar Free Extra Strong Menthol Menthol LOZENGE ORAL 20140203 OTC MONOGRAPH NOT FINAL part356 Mondelez Global LLC MENTHOL 15 mg/1 12546-314_6ccdfdc8-d6c6-46a0-95c3-c722e1822fe0 12546-314 HUMAN OTC DRUG HallsSugar Free Extra Sugar Free Extra Strong Menthol Menthol LOZENGE ORAL 20140204 OTC MONOGRAPH NOT FINAL part356 Mondelez Global LLC MENTHOL 18 mg/1 12546-315_8ba5679f-52bb-49d8-802f-fbca3ac7d437 12546-315 HUMAN OTC DRUG HallsMelon Splash Melon Splash Menthol LOZENGE ORAL 20140204 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 3.1 mg/1 12546-316_9bd83481-5516-4cff-858f-853e0fde5235 12546-316 HUMAN OTC DRUG Halls Melon Splash Menthol LOZENGE ORAL 20140130 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 2.7 mg/1 12546-321_94cbfcf2-9559-4bec-8a15-a7e8c0b94407 12546-321 HUMAN OTC DRUG Halls Menthol Menthol LOZENGE ORAL 20130503 OTC MONOGRAPH NOT FINAL part356 Mondel?z Group LLC MENTHOL 18 mg/1 12546-352_7194e750-d7d5-4e72-9830-0a4204267030 12546-352 HUMAN OTC DRUG Breezers Creamy Strawberry Pectin LOZENGE ORAL 20131001 OTC MONOGRAPH NOT FINAL part356 Mondelez Global LLC PECTIN 7 mg/1 12546-613_d1aa1e80-cc78-4de1-b790-d19ab668942f 12546-613 HUMAN OTC DRUG Halls Sugar Free Citrus Blend Menthol LOZENGE ORAL 20130730 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5 mg/1 12546-640_d585fa83-e286-4c4e-956f-0b008bc14468 12546-640 HUMAN OTC DRUG Halls Sugar Free Mountain Menthol Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5.8 mg/1 12546-642_e1a4183e-511d-4efe-b8fb-abc6c8aa552e 12546-642 HUMAN OTC DRUG Halls Sugar Free Honey Lemon Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 7.6 mg/1 12546-720_6a47fe8e-e2ba-4690-81b9-665b6af0db5c 12546-720 HUMAN OTC DRUG Halls Breezers Sugar Free Cool Berry Pectin LOZENGE ORAL 20120112 OTC MONOGRAPH NOT FINAL part356 Kraft Foods Global, Inc. PECTIN 7 mg/1 12546-985_08109a1f-5071-4c8c-b7f0-8de7e1dd0f0b 12546-985 HUMAN OTC DRUG Halls Plus Strawberry Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 2.7 mg/1 12546-987_fc179fe5-620d-417f-aceb-b43ddab732f1 12546-987 HUMAN OTC DRUG Halls Plus Honey Menthol LOZENGE ORAL 20140129 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 7.5 mg/1 12546-988_9db7643f-afac-445a-9c47-161f3ddc5939 12546-988 HUMAN OTC DRUG Halls Plus Cherry Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 7.5 mg/1 12634-000_a87c1b3f-50cf-4291-a92c-77a0728d93a7 12634-000 HUMAN OTC DRUG Constipation Relief Alumina, Bryonia, Graphites, Natrum Muriaticum, Silicea LIQUID ORAL 20141030 UNAPPROVED HOMEOPATHIC Apotheca Inc ALUMINUM OXIDE; BRYONIA ALBA ROOT; GRAPHITE; SILICON DIOXIDE; SODIUM CHLORIDE 8; 8; 8; 8; 8 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 12634-001_3c97f019-fba2-4397-9577-bf9ec957ca46 12634-001 HUMAN OTC DRUG Gallbladder Relief Belladonna, Carduus Marianus, Chelidonium Majus, Colocynthis, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vornica, Phosphorus, Pulsatilla, Veratrum Album TABLET ORAL 20141111 UNAPPROVED HOMEOPATHIC Apotheca Inc ATROPA BELLADONNA; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601 12634-028_763b33f0-84dd-4bd0-9122-21245c0d515f 12634-028 HUMAN PRESCRIPTION DRUG PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE TABLET ORAL 20100401 ANDA ANDA089452 Apotheca, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 12634-111_131d4041-7086-411f-ab71-37c091d1377a 12634-111 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 19960401 OTC MONOGRAPH NOT FINAL part343 Apotheca, Inc ACETAMINOPHEN 325 mg/1 12634-118_8ef862cd-d11d-4f51-a518-a8fcd12b53cb 12634-118 HUMAN PRESCRIPTION DRUG BENZPHETAMINE hYDROCHLORIDE BENAPHETAMINE TABLET ORAL 20091209 ANDA ANDA040747 Apotheca Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 12634-120_9e5f53d8-1f64-4021-8b6e-7f74694919ab 12634-120 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19830415 OTC MONOGRAPH NOT FINAL part343 Apotheca, Inc ASPIRIN 325 g/1 12634-144_68fe60f5-37c3-4256-9c9d-33d3e3580a90 12634-144 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20090320 ANDA ANDA040746 Apotheca, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 12634-160_543aa8e5-219e-41d8-8ffa-9ae1446d3391 12634-160 HUMAN PRESCRIPTION DRUG INDOMETHACIN ER INDOMETHACIN CAPSULE ORAL 20100304 ANDA ANDA079175 Apotheca, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 12634-166_d1473f26-2631-4493-87ef-8328b12e8e1a 12634-166 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20090924 ANDA ANDA040094 Apotheca Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 12634-171_c9a9b795-1424-4ccb-bd87-991833ca08e2 12634-171 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET ORAL 19910211 ANDA ANDA075682 Apotheca, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 12634-177_db550e63-43dc-4126-b857-010383501dd0 12634-177 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim DS Sulfamethoxazole and Trimethoprim DS TABLET ORAL 19940621 ANDA ANDA076899 Apotheca Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 12634-179_0048d662-23c4-4e28-815e-ce094951da05 12634-179 HUMAN PRESCRIPTION DRUG METHERGINE METHYLERGONOVINE MALEATE TABLET, COATED ORAL 20061227 NDA NDA006035 Apotheca, Inc. METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 12634-183_9ae064b6-e159-4b0e-a4c5-cc92229b2250 12634-183 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN CAPSULE ORAL 20050308 ANDA ANDA065271 Apotheca Inc. AMOXICILLIN 250 mg/1 12634-185_9ae064b6-e159-4b0e-a4c5-cc92229b2250 12634-185 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN CAPSULE ORAL 20050308 ANDA ANDA065271 Apotheca Inc. AMOXICILLIN 500 mg/1 12634-191_c9a9b795-1424-4ccb-bd87-991833ca08e2 12634-191 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET ORAL 19961223 ANDA ANDA075682 Apotheca, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 12634-260_22c1eeb7-1806-4493-b0a0-fd4127f6d908 12634-260 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminphen TABLET ORAL 20140108 ANDA ANDA090118 Apotheca, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 12634-264_223ae6bd-ab66-4870-8298-481309c24474 12634-264 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate with Acetaminophen Hydrocodone Bitartrate with Acetaminophen TABLET ORAL 20090312 ANDA ANDA040099 Apotheca Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 12634-418_ca133ae3-6acb-4d3e-82e0-4946943b7440 12634-418 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19990610 ANDA ANDA091179 Apotheca, Inc PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 12634-437_2c1558dc-1b76-4165-b872-ad35648676cf 12634-437 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20100210 ANDA ANDA089346 Apotheca, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 12634-438_746b74f0-81e8-4cf1-9b21-19309709ea81 12634-438 HUMAN PRESCRIPTION DRUG Carisoprodol and Aspirin Carisoprodol and Aspirin TABLET ORAL 20091001 ANDA ANDA040116 Apotheca, Inc. ASPIRIN; CARISOPRODOL 325; 200 mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 12634-445_f603db60-428d-470d-96d6-2c9486dfa784 12634-445 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 19961221 ANDA ANDA084325 Apotheca, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 12634-452_35d798c1-9d09-44c0-8a23-32f76f2f2b23 12634-452 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20100513 ANDA ANDA090278 APOTHECA, INC TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 12634-453_35d798c1-9d09-44c0-8a23-32f76f2f2b23 12634-453 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET ORAL 20100513 ANDA ANDA090278 APOTHECA, INC TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 12634-465_91f3b736-ecf5-4517-b8d9-a151308db836 12634-465 HUMAN PRESCRIPTION DRUG Clonidine HYDROCHLORIDE Clonidine HYDROCHLORIDE TABLET ORAL 19961221 ANDA ANDA070974 Apotheca, Inc CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 12634-471_f603db60-428d-470d-96d6-2c9486dfa784 12634-471 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 20090630 ANDA ANDA084324 Apotheca, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 12634-502_f01449fe-8751-43b6-b1c2-89a7f920f2e2 12634-502 HUMAN PRESCRIPTION DRUG MISOPROSTOL MISOPROSTOL TABLET ORAL 19970917 NDA NDA019268 Apotheca, Inc. MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 12634-516_a39c59dd-024e-45e3-a18c-d24979112fa8 12634-516 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE ORAL 19980601 ANDA ANDA040875 Apotheca, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 12634-518_2757f53a-602c-4678-80f5-61c3d9dfd4a3 12634-518 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20140214 ANDA ANDA091239 Apotheca, Inc IBUPROFEN 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 12634-525_36442f47-ca13-4bb4-9ec0-b9bbc4d6ec69 12634-525 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20000118 ANDA ANDA074215 Apotheca, Inc ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 12634-526_01bcf883-dd64-47a9-8576-ae6ddcdb6cce 12634-526 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET ORAL 20020503 ANDA ANDA089805 Apotheca, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 12634-529_7f85d8a7-0144-44d4-9a61-fb24a144d5c8 12634-529 HUMAN PRESCRIPTION DRUG DIAZEPAM DIAZEPAM TABLET ORAL 20091209 ANDA ANDA071321 Apotheca, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 12634-530_25438014-410b-48aa-b81f-d9d0f1f98435 12634-530 HUMAN PRESCRIPTION DRUG DIETHYLPROPION HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE TABLET ORAL 19990816 ANDA ANDA011722 Apotheca Inc DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 12634-531_9f70ec39-a095-4f05-b71a-fea9e641b543 12634-531 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20090825 ANDA ANDA085762 APOTHECA, INC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 12634-537_ab220c1d-8551-4a9d-b4d3-9199121420df 12634-537 HUMAN PRESCRIPTION DRUG PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLET, FILM COATED ORAL 20090101 ANDA ANDA074119 Apotheca, Inc. ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 650; 100 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 12634-539_763b33f0-84dd-4bd0-9122-21245c0d515f 12634-539 HUMAN PRESCRIPTION DRUG PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE TABLET ORAL 19990813 ANDA ANDA089452 Apotheca, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 12634-547_a39c59dd-024e-45e3-a18c-d24979112fa8 12634-547 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE ORAL 20100115 ANDA ANDA087022 Apotheca, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 12634-552_a39c59dd-024e-45e3-a18c-d24979112fa8 12634-552 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE ORAL 19991108 ANDA ANDA040886 Apotheca, Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 12634-553_f8ec8a93-e57a-4f34-8d2c-fdd0f2be3306 12634-553 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE ORAL 19991108 ANDA ANDA040887 Apotheca, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 12634-607_60d3cc49-2b2b-4b64-bbfb-32814a6da433 12634-607 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ALPRAZOLAM TABLET ORAL 20120630 ANDA ANDA074342 APOTHECA, INC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 12634-615_b97e818f-af7d-450b-8337-789ef40ec114 12634-615 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen SOLUTION ORAL 20130618 ANDA ANDA040182 APOTHECA, INC ACETAMINOPHEN; HYDROCODONE BITARTRATE 167; 2.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 12634-616_91924151-259e-4f6b-869c-01ba4a4729ae 12634-616 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen hydrocodone bitartrate and acetaminophen SOLUTION ORAL 20140331 ANDA ANDA040838 Apotheca, Inc ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/120mL; mg/120mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII 12634-682_c9a9b795-1424-4ccb-bd87-991833ca08e2 12634-682 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET ORAL 20090209 ANDA ANDA075682 Apotheca, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 12634-687_f8ec8a93-e57a-4f34-8d2c-fdd0f2be3306 12634-687 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE TABLET ORAL 20020812 ANDA ANDA040527 Apotheca, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 12634-691_25438014-410b-48aa-b81f-d9d0f1f98435 12634-691 HUMAN PRESCRIPTION DRUG DIETHYLPROPION HYDROCHLORIDE ER DIETHYLPROPION HYDROCHLORIDE ER TABLET ORAL 20081023 ANDA ANDA011722 Apotheca Inc DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 12634-698_7f85d8a7-0144-44d4-9a61-fb24a144d5c8 12634-698 HUMAN PRESCRIPTION DRUG DIAZEPAM DIAZEPAM TABLET ORAL 20090115 ANDA ANDA070154 Apotheca, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 12634-779_51ea5805-beef-4741-a63e-76bf0fe03153 12634-779 HUMAN PRESCRIPTION DRUG SULFAMETHOXAZOLE and TRIMETHOPRIM SULFAMETHOXAZOLE and TRIMETHOPRIM SUSPENSION ORAL 20091103 ANDA ANDA074650 Apotheca, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 12634-782_58d64590-3142-4ba9-9777-7174049514c5 12634-782 HUMAN PRESCRIPTION DRUG BONTRIL PHENDIMETRAZINE TARTRATE CAPSULE ORAL 20100408 ANDA ANDA088021 Apotheca, Inc. PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 12634-783_d1473f26-2631-4493-87ef-8328b12e8e1a 12634-783 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20060502 ANDA ANDA081080 Apotheca Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 12634-786_a5531d3d-ffce-4a3f-88f9-59626dd98c91 12634-786 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET ORAL 20050426 ANDA ANDA075964 APOTHECA, INC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 12634-809_69956c5a-014b-4e75-b4c1-6e51d7e80315 12634-809 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET ORAL 20051025 ANDA ANDA074754 Apotheca, Inc KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 12634-827_bf8d9912-f32f-41d3-8173-a60c80fddc77 12634-827 HUMAN PRESCRIPTION DRUG DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM TABLET ORAL 20070820 ANDA ANDA075229 APOTHECA, INC DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 12634-838_543aa8e5-219e-41d8-8ffa-9ae1446d3391 12634-838 HUMAN PRESCRIPTION DRUG INDOMETHACIN ER INDOMETHACIN CAPSULE ORAL 20060502 ANDA ANDA074464 Apotheca, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 12634-849_d1473f26-2631-4493-87ef-8328b12e8e1a 12634-849 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20070423 ANDA ANDA081083 Apotheca Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 12634-860_6e315790-ef94-4772-8e76-2565f8b097d4 12634-860 HUMAN OTC DRUG IBUPROFEN IBUPROFEN TABLET ORAL 20090916 ANDA ANDA071333 Apotheca Inc. IBUPROFEN 200 mg/1 12634-867_5f71530d-599c-4eb7-bbf4-716dfdfd09ed 12634-867 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20011211 ANDA ANDA076045 Apotheca, Inc LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 12634-907_60afef1d-5844-48c5-8194-a817bccf1ed5 12634-907 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Codeine Phosphate Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20120216 ANDA ANDA090180 APOTHECA, INC CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 12634-908_6bd465a1-3575-4d4a-9887-e25835cbd5bc 12634-908 HUMAN PRESCRIPTION DRUG PROMETHAZINE WITH CODEINE PROMETHAZINE WITH CODEINE LIQUID ORAL 20100101 ANDA ANDA088875 Apotheca, Inc. CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CV 12634-909_6bd465a1-3575-4d4a-9887-e25835cbd5bc 12634-909 HUMAN PRESCRIPTION DRUG PROMETHAZINE WITH CODEINE PROMETHAZINE WITH CODEINE LIQUID ORAL 20090601 ANDA ANDA040151 Apotheca, Inc. CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CV 12634-910_68209b15-ba77-478f-a715-e3c8a17d7b61 12634-910 HUMAN PRESCRIPTION DRUG PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE CAPSULE ORAL 20100110 ANDA ANDA018074 Apotheca, Inc. PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 12634-933_51ae34a7-a5eb-47de-8798-60e55a1db305 12634-933 HUMAN PRESCRIPTION DRUG CYTOTEC MISOPROSTOL TABLET ORAL 20100101 NDA NDA019268 Apotheca, Inc MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 12634-942_07f367ed-e5b9-40ec-b812-f5d5a5f7a774 12634-942 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20070723 ANDA ANDA040330 Apotheca, Inc ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 12634-943_9fd5fff8-1baf-4d32-b4d8-9c6fd1de45d4 12634-943 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET ORAL 20070725 ANDA ANDA077884 APOTHECA, INC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 12634-944_9fd5fff8-1baf-4d32-b4d8-9c6fd1de45d4 12634-944 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET ORAL 20070925 ANDA ANDA077884 APOTHECA, INC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 12634-969_5a66f7eb-5670-4ee1-b48f-0d0a11b554c6 12634-969 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate SOLUTION ORAL 20110128 OTC MONOGRAPH FINAL part341 Apotheca, Inc CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 12634-975_0bbf4210-4486-44a0-b0d5-62643c85a0ff 12634-975 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE Acetaminophen and Codeine Phosphate SOLUTION ORAL 20090904 ANDA ANDA040119 APOTHECA, INC. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 12634-980_f01449fe-8751-43b6-b1c2-89a7f920f2e2 12634-980 HUMAN PRESCRIPTION DRUG MISOPROSTOL MISOPROSTOL TABLET ORAL 20100225 ANDA ANDA076095 Apotheca, Inc. MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 12634-987_4ff5ce14-77ce-4757-a40e-e7099f15a011 12634-987 HUMAN OTC DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET ORAL 20100101 ANDA ANDA076677 Apotheca Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 12745-105_1add0222-f6f9-43f7-879f-ce14c4658fa0 12745-105 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19540615 OTC MONOGRAPH FINAL part344 Medical Chemical Corporation ISOPROPYL ALCOHOL 70.14 g/100mL 12745-109_61eeabe3-7b12-4352-af52-6e972905d281 12745-109 HUMAN OTC DRUG Compound Benzoin Tincture Tincture of Benzoin LIQUID TOPICAL 19540615 OTC MONOGRAPH NOT FINAL part356 Medical Chemical Corporation BENZOIN RESIN 10 g/100mL 12745-140_6a30d77e-3013-482f-919c-2e48f8115a6d 12745-140 HUMAN OTC DRUG Tincture Green Soap Alcohol LIQUID TOPICAL 19540615 OTC MONOGRAPH NOT FINAL part333A Medical Chemical Corporation ALCOHOL; POTASSIUM HYDROXIDE; ROSIN 24.93; 5.961; 2.47 g/100mL; g/100mL; g/100mL 12745-144_1f8cd25d-2a5e-497b-ad2d-a10193ac80cd 12745-144 HUMAN OTC DRUG Surgicide Povidone Iodine POVIDONE IODINE LIQUID TOPICAL 19770803 OTC MONOGRAPH FINAL part333C Medical Chemical Corporation POVIDONE-IODINE 10.5 g/100mL 12745-145_bb149645-85a8-4cb4-9ccc-ff15b2bd1ddf 12745-145 HUMAN OTC DRUG BAK 1 750 Benzalkonium Chloride LIQUID TOPICAL 19540615 OTC MONOGRAPH NOT FINAL part333E Medical Chemical Corporation BENZALKONIUM CHLORIDE .1713 g/100mL 12745-146_4db39bc8-ca53-4674-8e8e-71f9acb14183 12745-146 HUMAN OTC DRUG Scrubidine Povidone Iodine Surgical Scrub POVIDONE IODINE LIQUID TOPICAL 19770803 OTC MONOGRAPH FINAL part333C Medical Chemical Corporation POVIDONE-IODINE 8.64 g/100mL 12745-177_2832db2c-9a44-4dfc-9fba-d2aaaf23f486 12745-177 HUMAN OTC DRUG Antiseptic Hand Wash Ethyl Alcohol LIQUID TOPICAL 20010514 OTC MONOGRAPH FINAL part333 Medical Chemical Corporation ALCOHOL; DIAZOLIDINYLUREA 59.86; 1 g/100mL; g/100mL 12745-202_779e1919-9bd1-44b2-9fb8-6db862d0e03a 12745-202 HUMAN OTC DRUG HYDROGEN PEROXIDE HYDROGEN PEROXIDE LIQUID TOPICAL 19800721 OTC MONOGRAPH NOT FINAL part333A Medical Chemical Corporation HYDROGEN PEROXIDE 8.57 g/100mL 12745-541_1ba6268f-139f-4e43-99f5-c2c948700919 12745-541 HUMAN OTC DRUG Tinted Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19540615 OTC MONOGRAPH FINAL part344 Medical Chemical Corporation ISOPROPYL ALCOHOL 70.14 g/100mL 12753-305_adbcd49c-e0c4-40d9-8595-41c1b4406dee 12753-305 HUMAN OTC DRUG 999 COLD REMEDY Acetaminophen, Chlorpheniramine Maleate, Caffeine CAPSULE ORAL 20030703 OTC MONOGRAPH NOT FINAL part343 China Resources Sanjiu Medical & Pharmaceutical Co Ltd ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 100; 2 mg/6000mg; mg/6000mg 12753-307_3638fcd4-3721-4e7d-8b1d-14e1d358e13d 12753-307 HUMAN OTC DRUG 999 COLD REMEDY GRANULAR Acetaminophen, Chlorpheniramine Maleate GRANULE ORAL 20030703 OTC MONOGRAPH NOT FINAL part343 China Resources Sanjiu Medical & Pharmaceutical Co Ltd ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 200; 4 mg/90g; mg/90g 12753-930_1a9c76a3-1488-47f4-b75c-14e2bef779f3 12753-930 HUMAN OTC DRUG 999 ITCH RELIEF MENTHOL OINTMENT TOPICAL 20030703 OTC MONOGRAPH NOT FINAL part348 China Resources Sanjiu Medical & Pharmaceutical Co Ltd CAMPHOR (SYNTHETIC); DEXAMETHASONE; MENTHOL 200; 15; 200 mg/20000mg; mg/20000mg; mg/20000mg 12823-400_fab5934e-3093-4196-bc00-a74b6c0dc729 12823-400 HUMAN OTC DRUG TENDERWRAP Zinc Oxide DRESSING TOPICAL 20100729 OTC MONOGRAPH FINAL part347 Tyco Healthcare Group LP ZINC OXIDE 25 g/1 12823-401_e0388a81-afc9-4ed4-99d8-32f237a11cab 12823-401 HUMAN OTC DRUG TENDERWRAP Zinc Oxide, Calamine DRESSING TOPICAL 20100729 OTC MONOGRAPH FINAL part347 Tyco Healthcare Group LP FERRIC OXIDE RED; ZINC OXIDE; ZINC OXIDE .015; .985; 25 g/1; g/1; g/1 12829-2000_4fe300ac-ad09-41c4-abab-eb012f223180 12829-2000 HUMAN OTC DRUG Res-Q Topical Analgesic Soothing LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20140226 OTC MONOGRAPH NOT FINAL part348 CONAIR CORPORATION LIDOCAINE HYDROCHLORIDE 4 g/100g 12829-2001_6658a96d-791b-435b-9e86-7b464c322e61 12829-2001 HUMAN OTC DRUG Res-Q Analgesic Topical Pain Relief LIDOCAINE HYDROCHLORIDE LIQUID TOPICAL 20140226 OTC MONOGRAPH NOT FINAL part348 CONAIR CORPORATION LIDOCAINE HYDROCHLORIDE 40 mg/mL 12830-717_2e0028ff-15c6-43c4-b72a-de48df05f38e 12830-717 HUMAN OTC DRUG M-CLEAR WC Codeine Phosphate, Guaifenesin LIQUID ORAL 20081030 OTC MONOGRAPH FINAL part341 R.A. McNeil Company CODEINE PHOSPHATE; GUAIFENESIN 6.33; 100 mg/5mL; mg/5mL CV 12830-735_742f4102-ffa6-454f-b76f-d13b86074bb7 12830-735 HUMAN OTC DRUG M-END WC Codeine Phosphate, Pseudoephedrine Hydrochloride, Brompheniramine Maleate LIQUID ORAL 20080930 OTC MONOGRAPH FINAL part341 R.A. McNeil Company BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1.33; 6.33; 10 mg/5mL; mg/5mL; mg/5mL CV 12830-739_420b9986-23b6-4872-954e-03496f12ad30 12830-739 HUMAN OTC DRUG M-END MAX D Codeine Phosphate, Dexbrompheniramine Maleate, Pseudoephedrine Hydrochloride LIQUID ORAL 20111013 OTC MONOGRAPH FINAL part341 R.A. McNeil Company CODEINE PHOSPHATE; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 6; .667; 20 mg/5mL; mg/5mL; mg/5mL CV 12830-754_0b72a8c1-a03c-6522-e054-00144ff88e88 12830-754 HUMAN OTC DRUG M-END PE Codeine Phosphate, Phenylephrine Hydrochloride, Brompheniramine Maleate LIQUID ORAL 20081111 OTC MONOGRAPH FINAL part341 R.A. McNeil Company BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE 1.33; 6.33; 3.33 mg/5mL; mg/5mL; mg/5mL CV 12830-760_0c587438-050e-4511-b2c0-608bfb4b880a 12830-760 HUMAN OTC DRUG Chlo Tuss Chlophedianol Hydrochloride, Dexbrompheniramine Maleate, Phenylephrine Hydrochloride LIQUID ORAL 20091027 20150228 OTC MONOGRAPH FINAL part341 R.A. McNeil Company CHLOPHEDIANOL HYDROCHLORIDE; DEXBROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 12.5; 1; 5 mg/5mL; mg/5mL; mg/5mL 12830-762_8b87fa66-4bbc-4ccd-b72c-b8444f251e0d 12830-762 HUMAN OTC DRUG Chlo Tuss Chlophedianol Hydrochloride, Dexbrompheniramine Maleate, Pseudoephedrine Hydrochloride LIQUID ORAL 20131001 OTC MONOGRAPH FINAL part341 R.A. McNeil Company CHLOPHEDIANOL HYDROCHLORIDE; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 12.5; 1; 30 mg/5mL; mg/5mL; mg/5mL 12830-767_4f074791-73f6-4781-9ba0-80294a5d5397 12830-767 HUMAN OTC DRUG Chlo Tuss EX Chlophedianol Hydrochloride, Guaifenesin LIQUID ORAL 20110930 OTC MONOGRAPH FINAL part341 R. A. McNeil Company CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN 12.5; 100 mg/5mL; mg/5mL 12830-810_9e0db3ab-ee9e-4523-b269-e07a9799bd5c 12830-810 HUMAN OTC DRUG M-END DM Chlorpheniramine Maleate, Dextromethorphan Hydrobromiede, and Pseudoephedrine Hydrochloride LIQUID ORAL 20081113 OTC MONOGRAPH FINAL part341 R.A. McNeil Company CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 15; 15 mg/5mL; mg/5mL; mg/5mL 12830-816_5f74cc24-e543-4f62-b855-7b68cf3c8b7e 12830-816 HUMAN OTC DRUG M-END DMX Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride LIQUID ORAL 20111013 OTC MONOGRAPH FINAL part341 R. A. McNeil Company DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE .667; 10; 20 mg/5mL; mg/5mL; mg/5mL 12830-864_0462ad3b-ce81-3c9d-e054-00144ff8d46c 12830-864 HUMAN OTC DRUG Chlo Hist Chlophedianol Hydrochloride, Dexbrompheniramine Maleate LIQUID ORAL 20140915 OTC MONOGRAPH FINAL part341 R. A. McNeil Company CHLOPHEDIANOL HYDROCHLORIDE; DEXBROMPHENIRAMINE MALEATE 12.5; 1 mg/5mL; mg/5mL 12948-001_f7f9b55d-95f7-45e0-8afc-33a3065017e3 12948-001 HUMAN PRESCRIPTION DRUG BiDil Hydralazine hydrochloride and Isosorbide dinitrate TABLET, FILM COATED ORAL 20050623 NDA NDA020727 Arbor Pharmaceuticals HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE 37.5; 20 mg/1; mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 13107-001_b45a61f0-6179-45fa-929d-7536bd659190 13107-001 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Aurolife Pharma LLC MIRTAZAPINE 7.5 mg/1 13107-003_b45a61f0-6179-45fa-929d-7536bd659190 13107-003 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Aurolife Pharma LLC MIRTAZAPINE 30 mg/1 13107-005_2627f188-05c8-44ac-845e-80678a0c2fdd 13107-005 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20090101 ANDA ANDA077031 Aurolife Pharma LLC CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13107-006_2627f188-05c8-44ac-845e-80678a0c2fdd 13107-006 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20090101 ANDA ANDA077031 Aurolife Pharma LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13107-007_2627f188-05c8-44ac-845e-80678a0c2fdd 13107-007 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20090101 ANDA ANDA077031 Aurolife Pharma LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13107-011_966d728e-87ca-4491-9411-2ec253eca632 13107-011 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20110315 ANDA ANDA077206 Aurolife Pharma LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13107-012_966d728e-87ca-4491-9411-2ec253eca632 13107-012 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20110315 ANDA ANDA077206 Aurolife Pharma LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13107-013_966d728e-87ca-4491-9411-2ec253eca632 13107-013 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20110315 ANDA ANDA077206 Aurolife Pharma LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13107-014_4821ae32-1354-4c4a-9cb7-16b12f84f204 13107-014 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20130415 ANDA ANDA202675 Aurolife Pharma, LLC GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 13107-019_4eb6d275-e5d1-4fc3-9b85-fde586960286 13107-019 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120412 ANDA ANDA201013 Aurolife Pharma LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 13107-020_4eb6d275-e5d1-4fc3-9b85-fde586960286 13107-020 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120412 ANDA ANDA201013 Aurolife Pharma LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 13107-021_4eb6d275-e5d1-4fc3-9b85-fde586960286 13107-021 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120412 ANDA ANDA201013 Aurolife Pharma LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 13107-031_b45a61f0-6179-45fa-929d-7536bd659190 13107-031 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Aurolife Pharma LLC MIRTAZAPINE 15 mg/1 13107-032_b45a61f0-6179-45fa-929d-7536bd659190 13107-032 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Aurolife Pharma LLC MIRTAZAPINE 45 mg/1 13107-035_24163442-dd03-4066-a6ed-eb7e292b700b 13107-035 HUMAN PRESCRIPTION DRUG DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET ORAL 20120214 ANDA ANDA202893 Aurolife Pharma, LLC DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 13107-036_24163442-dd03-4066-a6ed-eb7e292b700b 13107-036 HUMAN PRESCRIPTION DRUG DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET ORAL 20120214 ANDA ANDA202893 Aurolife Pharma, LLC DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 13107-043_8229f1a8-4217-461a-ab2c-7a883c56f023 13107-043 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20121130 ANDA ANDA201972 Aurolife Pharma LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 2.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 13107-044_8229f1a8-4217-461a-ab2c-7a883c56f023 13107-044 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20121130 ANDA ANDA201972 Aurolife Pharma LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 13107-045_8229f1a8-4217-461a-ab2c-7a883c56f023 13107-045 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20121130 ANDA ANDA201972 Aurolife Pharma LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 13107-046_8229f1a8-4217-461a-ab2c-7a883c56f023 13107-046 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20121130 ANDA ANDA201972 Aurolife Pharma LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 13107-050_8a37015f-aa57-4a43-9ff0-2ca5540f357d 13107-050 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20091109 ANDA ANDA077691 Aurolife Pharma LLC SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 13107-051_8a37015f-aa57-4a43-9ff0-2ca5540f357d 13107-051 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20091109 ANDA ANDA077691 Aurolife Pharma LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 13107-052_8a37015f-aa57-4a43-9ff0-2ca5540f357d 13107-052 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20091109 ANDA ANDA077691 Aurolife Pharma LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 13107-053_8a37015f-aa57-4a43-9ff0-2ca5540f357d 13107-053 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20091109 ANDA ANDA077691 Aurolife Pharma LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 13107-054_8a37015f-aa57-4a43-9ff0-2ca5540f357d 13107-054 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20091109 ANDA ANDA077691 Aurolife Pharma LLC SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 13107-055_5176403a-4709-4fc6-b1a9-72198e35bff5 13107-055 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20120712 ANDA ANDA202160 Aurolife Pharma LLC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 13107-056_5176403a-4709-4fc6-b1a9-72198e35bff5 13107-056 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20120712 ANDA ANDA202160 Aurolife Pharma LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 13107-057_5176403a-4709-4fc6-b1a9-72198e35bff5 13107-057 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20120712 ANDA ANDA202160 Aurolife Pharma LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 13107-058_6343a0a6-3b4c-4030-ad47-a96be42ab112 13107-058 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20130415 ANDA ANDA202800 Aurolife Pharma, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 13107-059_6343a0a6-3b4c-4030-ad47-a96be42ab112 13107-059 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20130415 ANDA ANDA202800 Aurolife Pharma, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 13107-060_6343a0a6-3b4c-4030-ad47-a96be42ab112 13107-060 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20130415 ANDA ANDA202800 Aurolife Pharma, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 13107-061_c26ef43f-c32c-468e-9688-d57663aa3a6e 13107-061 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20110610 ANDA ANDA203068 Aurolife Pharma, LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 13107-062_88f1abdc-f53e-4ff9-b4c1-3cfbc2609b79 13107-062 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20100917 ANDA ANDA077739 Aurolife Pharma LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 13107-063_88f1abdc-f53e-4ff9-b4c1-3cfbc2609b79 13107-063 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20100917 ANDA ANDA077739 Aurolife Pharma LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 13107-064_88f1abdc-f53e-4ff9-b4c1-3cfbc2609b79 13107-064 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20100917 ANDA ANDA077739 Aurolife Pharma LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 13107-068_e6e2fc80-e0ad-485d-a6b1-2a74fd9c18a4 13107-068 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20131127 ANDA ANDA202424 Aurolife Pharma, LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 13107-069_e6e2fc80-e0ad-485d-a6b1-2a74fd9c18a4 13107-069 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20131127 ANDA ANDA202424 Aurolife Pharma, LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 13107-070_e6e2fc80-e0ad-485d-a6b1-2a74fd9c18a4 13107-070 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20131127 ANDA ANDA202424 Aurolife Pharma, LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 13107-071_e6e2fc80-e0ad-485d-a6b1-2a74fd9c18a4 13107-071 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20131127 ANDA ANDA202424 Aurolife Pharma, LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 13107-072_e6e2fc80-e0ad-485d-a6b1-2a74fd9c18a4 13107-072 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20131127 ANDA ANDA202424 Aurolife Pharma, LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 13107-073_e6e2fc80-e0ad-485d-a6b1-2a74fd9c18a4 13107-073 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20131127 ANDA ANDA202424 Aurolife Pharma, LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 13107-074_e6e2fc80-e0ad-485d-a6b1-2a74fd9c18a4 13107-074 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20131127 ANDA ANDA202424 Aurolife Pharma, LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 13107-076_c7605785-8db2-41eb-90e2-f12275b7b299 13107-076 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20090801 ANDA ANDA077859 Aurolife Pharma LLC CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 13107-077_c7605785-8db2-41eb-90e2-f12275b7b299 13107-077 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20090801 ANDA ANDA077859 Aurolife Pharma LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 13107-119_a8e32e4d-cb0a-491b-acbd-2627068e3a70 13107-119 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Aurolife Pharma LLC RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 13107-120_a8e32e4d-cb0a-491b-acbd-2627068e3a70 13107-120 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Aurolife Pharma LLC RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 13107-121_a8e32e4d-cb0a-491b-acbd-2627068e3a70 13107-121 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Aurolife Pharma LLC RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 13107-122_a8e32e4d-cb0a-491b-acbd-2627068e3a70 13107-122 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Aurolife Pharma LLC RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 13107-123_a8e32e4d-cb0a-491b-acbd-2627068e3a70 13107-123 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Aurolife Pharma LLC RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 13107-124_a8e32e4d-cb0a-491b-acbd-2627068e3a70 13107-124 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Aurolife Pharma LLC RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 13107-142_5581f10c-3a75-486e-9c3f-98c2c4df970d 13107-142 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 Aurolife Pharma LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 13107-143_5581f10c-3a75-486e-9c3f-98c2c4df970d 13107-143 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 Aurolife Pharma LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 13107-144_5581f10c-3a75-486e-9c3f-98c2c4df970d 13107-144 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 Aurolife Pharma LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 13107-145_5581f10c-3a75-486e-9c3f-98c2c4df970d 13107-145 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 Aurolife Pharma LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 13107-154_74d87221-53e0-4454-b37b-494e2fbc876d 13107-154 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 Aurolife Pharma LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13107-155_74d87221-53e0-4454-b37b-494e2fbc876d 13107-155 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 Aurolife Pharma LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13107-156_74d87221-53e0-4454-b37b-494e2fbc876d 13107-156 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 Aurolife Pharma LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13107-157_74d87221-53e0-4454-b37b-494e2fbc876d 13107-157 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 Aurolife Pharma LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13107-168_b72f170e-bfa6-463c-9345-31f8a37e43e2 13107-168 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110620 ANDA ANDA078512 Aurolife Pharma LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 13107-169_b72f170e-bfa6-463c-9345-31f8a37e43e2 13107-169 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110620 ANDA ANDA078512 Aurolife Pharma LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 13107-170_b72f170e-bfa6-463c-9345-31f8a37e43e2 13107-170 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110620 ANDA ANDA078512 Aurolife Pharma LLC ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 13136-001_cb18242d-5906-42e3-8212-d704e92ea43b 13136-001 HUMAN OTC DRUG fiteBac SkinCare Germicidal Hand Softening Benzalkonium Chloride GEL TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333E fiteBac SkinCare, LLC BENZALKONIUM CHLORIDE .029 mL/29.57mL 13267-123_879f8311-2765-43cc-bd7d-9c7292e842fe 13267-123 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F18 INJECTION INTRAVENOUS 20050819 NDA NDA021870 THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 13267-456_fa820045-dae1-41a9-b642-bbbff4547483 13267-456 HUMAN PRESCRIPTION DRUG Ammonia N 13 NH3N13 INJECTION INTRAVENOUS 20070823 NDA NDA022119 THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 13267-542_293ff570-c5de-4d2a-8bae-f6218b0b9559 13267-542 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 Sodium Fluoride F 18 INJECTION INTRAVENOUS 20141202 NDA NDA017042 FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH SODIUM FLUORIDE F-18 600 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 13302-785_e5da40f4-994c-4389-b39d-6fc04ca15bf1 13302-785 HUMAN OTC DRUG QS Plus Hand Sanitizing Wipes BENZETHONIUM CHLORIDE CLOTH TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Romaine Companies BENZETHONIUM CHLORIDE 2 mg/g 13310-101_26bcf80c-8314-4e10-b32c-452dbce94f7a 13310-101 HUMAN PRESCRIPTION DRUG FIBRICOR Fenofibric Acid TABLET ORAL 20090814 NDA NDA022418 AR Scientific, Inc. FENOFIBRIC ACID 35 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 13310-102_26bcf80c-8314-4e10-b32c-452dbce94f7a 13310-102 HUMAN PRESCRIPTION DRUG FIBRICOR Fenofibric Acid TABLET ORAL 20090814 NDA NDA022418 AR Scientific, Inc. FENOFIBRIC ACID 105 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 13310-119_d6eb54b7-2050-4449-85b8-1592cec62176 13310-119 HUMAN PRESCRIPTION DRUG Colcrys Colchicine TABLET, FILM COATED ORAL 20090901 NDA NDA022352 AR Scientific Inc. COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 13310-145_e4750422-45bb-4e1b-9a27-17d31bb588b2 13310-145 HUMAN PRESCRIPTION DRUG Bactrim Sulfamethoxazole and Trimethoprim TABLET ORAL 20041101 NDA NDA017377 AR Scientific, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 13310-146_e4750422-45bb-4e1b-9a27-17d31bb588b2 13310-146 HUMAN PRESCRIPTION DRUG Bactrim DS Sulfamethoxazole and Trimethoprim TABLET ORAL 20041101 NDA NDA017377 AR Scientific, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 13310-153_d2f8943c-0442-4ddc-a712-5c1c79fed29b 13310-153 HUMAN PRESCRIPTION DRUG Qualaquin Quinine Sulfate CAPSULE ORAL 20050812 NDA NDA021799 AR Scientific Inc. QUININE SULFATE 324 mg/1 Antimalarial [EPC] 13340-5624_4e7a3618-3d32-4b77-8a3e-023d4eb65ee6 13340-5624 HUMAN OTC DRUG Throat Coat Menthol PASTILLE ORAL 20050126 OTC MONOGRAPH NOT FINAL part356 Phytoneering Extract Solutions GmbH MENTHOL 2.5 mg/1 13533-603_c31228af-9ad1-99e5-b159-32af47e17df6 13533-603 PLASMA DERIVATIVE Thrombate III antithrombin III KIT 19911230 BLA BLA103196 GRIFOLS USA, LLC 13533-604_c31228af-9ad1-99e5-b159-32af47e17df6 13533-604 PLASMA DERIVATIVE Thrombate III antithrombin III KIT 19911230 BLA BLA103196 GRIFOLS USA, LLC 13533-613_d0cc341d-4d81-58d4-8f8a-1ccf8fc57669 13533-613 PLASMA DERIVATIVE Plasmanate Plasma Protein Fraction (Human) SOLUTION INTRAVENOUS 19581002 BLA BLA101140 GRIFOLS USA, LLC ALBUMIN (HUMAN) 2.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 13533-618_cd8a4d04-09ac-f9f2-b00d-7a5301eaf3f1 13533-618 PLASMA DERIVATIVE HyperRAB S/D Human Rabies Virus Immune Globulin INJECTION INTRAMUSCULAR 19960814 BLA BLA101144 GRIFOLS USA, LLC HUMAN RABIES VIRUS IMMUNE GLOBULIN 150 [iU]/mL 13533-631_ab97e9ae-c585-aa5a-6c4b-39f9cb6b69d3 13533-631 PLASMA DERIVATIVE HyperRHO S/D Full Dose Rho(D) Immune Globulin (Human) SOLUTION INTRAMUSCULAR 19960814 BLA BLA101141 GRIFOLS USA, LLC HUMAN RHO(D) IMMUNE GLOBULIN 1500 [iU]/[iU] Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 13533-634_5e9cb258-f264-1481-4519-120a0060ca98 13533-634 PLASMA DERIVATIVE HyperTET S/D Tetanus Immune Globulin (Human) INJECTION INTRAMUSCULAR 19960814 BLA BLA101142 GRIFOLS USA, LLC HUMAN CLOSTRIDIUM TETANI TOXOID IMMUNE GLOBULIN 250 [iU]/mL 13533-635_b21e77a6-7694-3d80-30f6-93a5bfb3308d 13533-635 PLASMA DERIVATIVE GamaSTAN S/D Immune Globulin (Human) INJECTION INTRAMUSCULAR 19960814 BLA BLA101134 GRIFOLS USA, LLC HUMAN IMMUNOGLOBULIN G .165 g/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 13533-636_dd5377f7-f78f-4cea-9b8a-82a279b68b2d 13533-636 PLASMA DERIVATIVE HyperHEP B S/D Hepatitis B Immune Globulin (Human) INJECTION INTRAMUSCULAR 19961009 BLA BLA101146 GRIFOLS USA, LLC HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 220 [iU]/mL Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] 13533-661_0d2b083e-7be8-0a13-5494-8849b2264810 13533-661 PLASMA DERIVATIVE HyperRHO S/D Mini-Dose RHo(D) Immune Globulin (Human) SOLUTION INTRAMUSCULAR 19960814 BLA BLA101141 GRIFOLS USA, LLC HUMAN RHO(D) IMMUNE GLOBULIN 250 [iU]/[iU] Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 13533-683_e2bb414c-2ab2-3098-af14-b7bcf05fb399 13533-683 PLASMA DERIVATIVE Plasbumin Albumin (Human) SOLUTION INTRAVENOUS 19810728 BLA BLA101138 GRIFOLS USA, LLC ALBUMIN (HUMAN) 10 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 13533-684_004cb37f-3bfa-1cca-5795-b20a705adf53 13533-684 PLASMA DERIVATIVE Plasbumin Albumin (Human) SOLUTION INTRAVENOUS 19421021 BLA BLA101138 GRIFOLS USA, LLC ALBUMIN (HUMAN) 5 g/20mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 13533-685_7eb5f211-8141-b25c-7488-658d57f86801 13533-685 PLASMA DERIVATIVE Plasbumin Albumin (Human) SOLUTION INTRAVENOUS 19760826 BLA BLA101138 GRIFOLS USA, LLC ALBUMIN (HUMAN) 2.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 13533-690_6dd43e2f-6020-68b7-f91e-aa06a15529ce 13533-690 PLASMA DERIVATIVE Plasbumin Albumin (Human) SOLUTION INTRAVENOUS 19940926 BLA BLA101138 GRIFOLS USA, LLC ALBUMIN (HUMAN) 2.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 13533-691_caca0549-df03-0d8e-ccb7-a9974830a106 13533-691 PLASMA DERIVATIVE Plasbumin Albumin (Human) SOLUTION INTRAVENOUS 19940926 BLA BLA101138 GRIFOLS USA, LLC ALBUMIN (HUMAN) 10 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 13533-692_71d3ea6a-0a27-d4ea-243b-ca3662039745 13533-692 PLASMA DERIVATIVE Plasbumin Albumin (Human) SOLUTION INTRAVENOUS 19940926 BLA BLA101138 GRIFOLS USA, LLC ALBUMIN (HUMAN) 5 g/20mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 13533-700_fddb3f8d-ea34-91a9-0f9f-0b7d5a381a96 13533-700 PLASMA DERIVATIVE PROLASTIN-C alpha-1-proteinase inhibitor human KIT 19871202 BLA BLA103174 GRIFOLS USA, LLC 13533-701_fddb3f8d-ea34-91a9-0f9f-0b7d5a381a96 13533-701 PLASMA DERIVATIVE PROLASTIN-C alpha-1-proteinase inhibitor human KIT 19871202 BLA BLA103174 GRIFOLS USA, LLC 13533-800_811c3ca7-b162-35fb-190c-8da2862d12f9 13533-800 PLASMA DERIVATIVE Gamunex-C Immune Globulin Intravenous (Human), 10% Caprylate Chromatography Purified INJECTION INTRAVENOUS 20101013 BLA BLA125046 GRIFOLS USA, LLC HUMAN IMMUNOGLOBULIN G 10 g/100mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 13537-001_fe86c6b3-60de-4706-bdcc-37d45bca0667 13537-001 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MARRON TOSCANA) - BROWN Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g 13537-002_fe86c6b3-60de-4706-bdcc-37d45bca0667 13537-002 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD PIMIENTA CALIENTE) - BROWN Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g 13537-003_fe86c6b3-60de-4706-bdcc-37d45bca0667 13537-003 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD VINO CAUTIVANTE) - RED Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g 13537-004_fe86c6b3-60de-4706-bdcc-37d45bca0667 13537-004 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSA VIVA) - PINK Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g 13537-005_fe86c6b3-60de-4706-bdcc-37d45bca0667 13537-005 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CORAL ENSUENO) - RED Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g 13537-006_fe86c6b3-60de-4706-bdcc-37d45bca0667 13537-006 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROJO GLAM) - RED Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g 13537-007_fe86c6b3-60de-4706-bdcc-37d45bca0667 13537-007 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CAFE HABANO) - BROWN Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g 13537-008_fe86c6b3-60de-4706-bdcc-37d45bca0667 13537-008 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FUCSIA VIBRANTE) - PINK Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g 13537-009_fe86c6b3-60de-4706-bdcc-37d45bca0667 13537-009 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD DURAZNO NUDE) - PINK Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g 13537-010_3aa2fe30-92c4-4d82-89d1-b9acf99f31f8 13537-010 HUMAN OTC DRUG CYZONE GIULIA Aluminum sesquichlorohydrate LIQUID TOPICAL 20110419 OTC MONOGRAPH FINAL part350 Ventura Corporation Limited ALUMINUM SESQUICHLOROHYDRATE .17 mL/mL 13537-011_0da5028f-027d-401e-8bbb-cbb5ca204e01 13537-011 HUMAN OTC DRUG LBel Effet Parfait Rouge Alissant Octinoxate and Oxybenzone LIPSTICK TOPICAL 20100815 OTC MONOGRAPH FINAL part352 VENTURA INTERNATIONAL LTD., OCTINOXATE; OXYBENZONE .24; .06 g/4g; g/4g 13537-012_764bfb1d-d860-46a5-9120-9cd2b2b9d815 13537-012 HUMAN OTC DRUG CYZONE CY OCTINOXATE and OCTOCRYLENE OINTMENT TOPICAL 20110121 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Limited OCTINOXATE; OCTOCRYLENE .06; .04 g/g; g/g 13537-013_764bfb1d-d860-46a5-9120-9cd2b2b9d815 13537-013 HUMAN OTC DRUG CYZONE CY OCTINOXATE and OCTOCRYLENE OINTMENT TOPICAL 20110121 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Limited OCTINOXATE; OCTOCRYLENE .06; .04 g/g; g/g 13537-014_764bfb1d-d860-46a5-9120-9cd2b2b9d815 13537-014 HUMAN OTC DRUG CYZONE CY OCTINOXATE and OCTOCRYLENE OINTMENT TOPICAL 20110121 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Limited OCTINOXATE; OCTOCRYLENE .06; .04 g/g; g/g 13537-015_764bfb1d-d860-46a5-9120-9cd2b2b9d815 13537-015 HUMAN OTC DRUG CYZONE CY OCTINOXATE and OCTOCRYLENE OINTMENT TOPICAL 20110121 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Limited OCTINOXATE; OCTOCRYLENE .06; .04 g/g; g/g 13537-016_fe86c6b3-60de-4706-bdcc-37d45bca0667 13537-016 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD NARANJA PROVOCACION) - ORANGE Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g 13537-017_fe86c6b3-60de-4706-bdcc-37d45bca0667 13537-017 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MELON INTENSE) - PINK Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g 13537-018_fe86c6b3-60de-4706-bdcc-37d45bca0667 13537-018 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSADO CHIC) - PINK Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g 13537-019_0b153b98-72fc-4125-b437-d0fa7fc058c2 13537-019 HUMAN OTC DRUG LBEL COULEUR LUXE ROUGE IRRESISTIBLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-020_8e687625-3c1c-4d25-8932-cf97d19e5587 13537-020 HUMAN OTC DRUG LBEL Couleur Luxe Supreme Laque OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; OXYBENZONE .07; .03 mL/mL; mL/mL 13537-021_d2f0744c-317a-44c4-b1a7-f23be28e7f12 13537-021 HUMAN OTC DRUG LBEL EFFET PARFAIT OCTINOXATE, OXYBENZONE, and TITANIUM DIOXIDE LIPSTICK TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .03; .008 g/g; g/g; g/g 13537-022_57de5149-3025-4753-b084-1be876cb8cd0 13537-022 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL TITANIUM DIOXIDE, OXYBENZONE, ZINC OXIDE, and OCTINOXATE POWDER TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE .035; .05; .06; .049 g/g; g/g; g/g; g/g 13537-023_906dbbed-59ec-44b0-a595-d67a62452f61 13537-023 HUMAN OTC DRUG EFFET PARFAIT natural finish moisturizing foundation SPF 25 Octinoxate and Titanium Dioxide LOTION TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; TITANIUM DIOXIDE .065; .016 mL/mL; mL/mL 13537-024_fe86c6b3-60de-4706-bdcc-37d45bca0667 13537-024 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CIRUELA GLAM) - RED Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g 13537-025_ac565e8f-4ea5-4a81-a24d-eaff466a0301 13537-025 HUMAN OTC DRUG LBEL REGRESSION JOUR Protective Complex with SPF 15 Facial day normal to dry skin Avobenzone, Ensulizole, Octinoxate, and Oxybenzone CREAM TOPICAL 20120514 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. AVOBENZONE; ENSULIZOLE; OCTINOXATE; OXYBENZONE .02; .01; .075; .02 g/g; g/g; g/g; g/g 13537-026_bab857e0-394d-4e26-af70-17e0cac83524 13537-026 HUMAN OTC DRUG LBEL PROTEGE EXPERT Octinoxate, Octisalate, Oxybenzone, and Titanium dioxide LOTION TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .075; .05; .06; .0234 g/mL; g/mL; g/mL; g/mL 13537-027_dd5be4e2-fa42-4add-bdb3-a7e27bdf2eb1 13537-027 HUMAN OTC DRUG LBEL PROTEGE EXPERT Ensulizole, Octinoxate, Octisalate, Oxybenzone, and Titanium dioxide LOTION TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. ENSULIZOLE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .03; .075; .05; .06; .039 g/mL; g/mL; g/mL; g/mL; g/mL 13537-028_d3ba2700-e939-4eee-b5df-31f75c93327a 13537-028 HUMAN OTC DRUG LBel Protege Expert Octinoxate, Octisalate, Octocrylene, Oxybenzone, and Titanium dioxide CREAM TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .075; .04; .1; .06; .01 g/g; g/g; g/g; g/g; g/g 13537-029_fe86c6b3-60de-4706-bdcc-37d45bca0667 13537-029 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MAGENTA SWEET) - PURPLE Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g 13537-030_fe86c6b3-60de-4706-bdcc-37d45bca0667 13537-030 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FRAMBUESA ENCANTO) - RED Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g 13537-031_517068e5-4daf-4657-8f88-bd145e6010e0 13537-031 HUMAN OTC DRUG LBEL Hydra Calme SPF 15 Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20110829 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. (San Juan, P.R) OCTINOXATE; OCTISALATE; OXYBENZONE .075; .04; .04 g/mL; g/mL; g/mL 13537-032_b95cbc27-afc2-486c-a3ee-38933aad7a58 13537-032 HUMAN OTC DRUG AINNARA Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20110923 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-033_4a4ef065-6831-421d-9785-592945752f59 13537-033 HUMAN OTC DRUG ALTHEUS For Men Aluminum Sesquichlorohydrate LIQUID TOPICAL 20110923 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-034_efba0ad0-6770-4e93-9d41-e7df3c9127f2 13537-034 HUMAN OTC DRUG CARDIGAN Roll-On Aluminum Sesquichlorohydrate STICK TOPICAL 20110923 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-035_febae930-324a-4a29-9ed5-abe1628c5651 13537-035 HUMAN OTC DRUG DARIEN Antiperspirant Roll-On Deodorant Aluminum Sesquichlorohydrate LIQUID TOPICAL 20110923 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-036_e7d6e963-61dc-46c1-b81e-89b218f5b5c0 13537-036 HUMAN OTC DRUG ESIKA DANZZIA Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-037_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-037 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g 13537-038_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-038 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g 13537-039_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-039 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g 13537-040_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-040 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g 13537-041_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-041 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g 13537-042_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-042 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g 13537-043_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-043 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g 13537-044_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-044 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g 13537-045_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-045 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g 13537-046_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-046 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g 13537-047_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-047 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g 13537-048_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-048 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g 13537-049_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-049 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g 13537-050_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-050 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g 13537-051_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-051 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g 13537-052_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-052 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g 13537-053_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-053 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g 13537-054_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-054 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g 13537-055_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-055 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g 13537-056_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-056 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g 13537-057_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-057 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g 13537-058_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-058 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g 13537-059_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-059 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g 13537-060_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-060 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g 13537-061_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-061 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (MARRON GLAMOUR) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g 13537-062_d8493cc9-c2ec-4808-aa47-67405295ba7c 13537-062 HUMAN OTC DRUG Esika EXUS Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-063_27978e9c-c623-4f67-979c-d06328160d65 13537-063 HUMAN OTC DRUG ESIKA FLOWERY Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-064_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-064 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO DESEO) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g 13537-065_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-065 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO INTRIGANTE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g 13537-066_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-066 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO LUJURIA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g 13537-067_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-067 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (CORAL CHIC) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g 13537-068_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-068 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA ENCANTO) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g 13537-069_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-069 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (BORGONA SEXY) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g 13537-070_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-070 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (FUCSIA CAUTIVANTE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g 13537-071_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-071 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (GRANATE SEDUCTOR) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g 13537-072_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-072 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA ROMANTICA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g 13537-073_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-073 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (NARANJA PRIMAVERA) - ORANGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g 13537-074_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-074 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (FRAMBUESA MANIA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g 13537-075_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-075 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA DULZURA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g 13537-076_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-076 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (PIMIENTA CALIENTE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g 13537-077_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-077 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 Octinoxate and Oxybenzone KIT 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD 13537-088_c71a5af0-420c-49cf-a28d-46d2224f10cf 13537-088 HUMAN OTC DRUG LBEL Hydra Calme Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTISALATE; OXYBENZONE 2.25; 1.2; 1.2 mg/30mL; mg/30mL; mg/30mL 13537-089_c71a5af0-420c-49cf-a28d-46d2224f10cf 13537-089 HUMAN OTC DRUG LBEL Hydra Calme Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTISALATE; OXYBENZONE .075; .04; .04 mg/mL; mg/mL; mg/mL 13537-100_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-100 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROSE NATURAL) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-101_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-101 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROJO VIF) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-102_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-102 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (MANDARINE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-103_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-103 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (CAPUCCINO) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-104_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-104 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (VIN) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-105_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-105 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (FUCHSIA INTENSE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-106_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-106 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROUGE BRILLANCE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-107_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-107 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROUGE INTENSE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-108_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-108 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (FUCHSIA BRILLANCE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-109_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-109 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROSE BRILLANCE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-110_29f0150d-79e4-4d74-862e-352c0057e84d 13537-110 HUMAN OTC DRUG CYZONE SUN BY ME Octinoxate, Oxybenzone, Octisalate, and Titanium dioxide LOTION TOPICAL 20110422 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Limited OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .075; .05; .05; .00948 g/mL; g/mL; g/mL; g/mL 13537-111_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-111 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROSE CLASSIQUE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-112_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-112 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (CLAIRE 1) - BEIGE Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g 13537-113_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-113 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (CLAIRE 2) - BEIGE Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g 13537-114_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-114 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (CLAIRE 4) - BEIGE Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g 13537-115_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-115 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (VIOLET POURPRE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-116_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-116 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ORANGE DELIRANT) - ORANGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-117_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-117 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROSE FEMME) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-118_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-118 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROUGE INTENSE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-119_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-119 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (DORE CHOCOLAT) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-120_86e32f16-b851-4880-8ef3-2f3cfef2cf0a 13537-120 HUMAN OTC DRUG ESIKA IMAGENES Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-121_eb6d5387-ba44-4c48-9b34-a81256ca38f1 13537-121 HUMAN OTC DRUG LBEL Divine Lip Gloss SPF 15 Octinoxate and Oxybenzone LOTION TOPICAL 20111114 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. (San Juan, P.R) OCTINOXATE; OXYBENZONE .075; .03 mL/mL; mL/mL 13537-122_2af2c4fe-eefc-4d6f-8087-95b4628a8a09 13537-122 HUMAN OTC DRUG CYZONE Body Manic Aluminum Sesquichlorohydrate LOTION TOPICAL 20111114 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .2 g/mL 13537-123_c789fd9b-5e71-480f-bb54-8bd33bef1c4b 13537-123 HUMAN OTC DRUG CYZONE CY Cover Mat Octinoxate and Titanium Dioxide CREAM TOPICAL 20111213 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; TITANIUM DIOXIDE .06; .008 g/g; g/g 13537-124_c789fd9b-5e71-480f-bb54-8bd33bef1c4b 13537-124 HUMAN OTC DRUG CYZONE CY Cover Mat Octinoxate and Titanium Dioxide CREAM TOPICAL 20111213 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; TITANIUM DIOXIDE .06; .008 g/g; g/g 13537-125_c789fd9b-5e71-480f-bb54-8bd33bef1c4b 13537-125 HUMAN OTC DRUG CYZONE CY Cover Mat Octinoxate and Titanium Dioxide CREAM TOPICAL 20111213 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; TITANIUM DIOXIDE .06; .008 g/g; g/g 13537-126_c789fd9b-5e71-480f-bb54-8bd33bef1c4b 13537-126 HUMAN OTC DRUG CYZONE CY Cover Mat Octinoxate and Titanium Dioxide CREAM TOPICAL 20111213 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; TITANIUM DIOXIDE .06; .008 g/g; g/g 13537-127_620a4be9-af67-4f5e-8cf2-747117821bf5 13537-127 HUMAN OTC DRUG Cyzone Be Sexy Pyrithione Zinc LOTION TOPICAL 20111213 OTC MONOGRAPH FINAL part358H Ventura Corporation Ltd. PYRITHIONE ZINC .0036 mg/mL 13537-128_ffc6eb5a-da91-4b57-bc83-fba1d2bd01ca 13537-128 HUMAN OTC DRUG ESIKA AVENTOUR Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-129_464ba5ee-ef90-4460-b659-8682ef4ac728 13537-129 HUMAN OTC DRUG ESIKA BRAVIO Christian Meier Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-130_72a98634-064c-46a7-99aa-6c7e75b9ea05 13537-130 HUMAN OTC DRUG ESIKA ROMANZI Christian Meier Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-131_dacb8904-2c6b-4914-84fc-075dc17c9145 13537-131 HUMAN OTC DRUG Esika Pulso Christian Meier Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-132_61e5d891-86c8-4fd2-81a3-61a4c6af713f 13537-132 HUMAN OTC DRUG ESIKA SALVAJE Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 mg/mL 13537-133_0422116e-2307-4eae-ba2e-c5a0e1d5a868 13537-133 HUMAN OTC DRUG ESIKA STRONG MUSK Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-134_49740eaf-b561-402c-88ec-463ef91e1eff 13537-134 HUMAN OTC DRUG ESIKA VALERUS FOR MEN Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-135_4de8ccf1-d045-486c-bfe9-4d755b320695 13537-135 HUMAN OTC DRUG ESIKA WINNER SPORT Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-136_fc17641f-6e8f-4090-b4a7-f91efb9478c4 13537-136 HUMAN OTC DRUG ESIKA WINNER TONIGHT Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-137_4c522542-f216-4eb0-8327-1603a73cf49f 13537-137 HUMAN OTC DRUG ESIKA ITS YOU Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-138_f6c1ec14-f14d-4c7c-a977-9ee3fd7093e9 13537-138 HUMAN OTC DRUG ESIKA ITS YOU LIVE Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-139_3438acfc-41d6-4a5c-9f09-6ad59c8d3d85 13537-139 HUMAN OTC DRUG ESIKA SECRET MUSK Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-140_0615bc58-6615-4af3-a13c-85548628209d 13537-140 HUMAN OTC DRUG ESIKA VANILLA HOMBRE Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-141_83e69bc3-4652-4459-bfc1-f4d7329bc02d 13537-141 HUMAN OTC DRUG ESIKA VANILLA SCENT Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-142_95ec8aef-349a-4a80-9d00-704219f1d175 13537-142 HUMAN OTC DRUG ESIKA WINNER BLACK Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-143_616b61e0-0680-40d0-92a9-8956c9fb7f77 13537-143 HUMAN OTC DRUG ESIKA VEHEMENCE FOR MEN Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-144_446af6bb-1356-450c-8916-4c1bbba73c78 13537-144 HUMAN OTC DRUG ESIKA FORZE Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 mg/mL 13537-145_6dbcb17a-90c4-4fe6-b0b4-e7369961afb5 13537-145 HUMAN OTC DRUG ESIKA VEHEMENCE FOR WOMAN Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-146_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-146 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (FUCSIA DESIR) - MAGENTA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-147_cdbf44a7-4c4a-45ff-b1e8-0cdc334d7c3a 13537-147 HUMAN OTC DRUG ESIKA Total Sec Neutral Fragrance 36 ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20120124 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd ALUMINUM SESQUICHLOROHYDRATE .162 g/mL 13537-148_92954fd7-301b-4075-8764-25a8430fe7dc 13537-148 HUMAN OTC DRUG LBel EFFET PARFAIT TITANIUM DIOXIDE, OXYBENZONE, and OCTINOXATE POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .04; .03; .04425 g/g; g/g; g/g 13537-149_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-149 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (MER DE ROSES) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-150_162e9516-8297-4782-a064-57ec823dc473 13537-150 HUMAN OTC DRUG LBel EFFET PARFAIT Loose Extra-Fine Portable TITANIUM DIOXIDE, OXYBENZONE, and OCTINOXATE POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .03; .03; .035 g/g; g/g; g/g 13537-151_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-151 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROUGE PROVOCATION) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-152_3d0e3123-a464-4af1-ae3d-8d44ad3d7e9e 13537-152 HUMAN OTC DRUG ESIKA NATURAL CARE Octinoxate and Oxybenzone CREAM TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd OCTINOXATE; OXYBENZONE .075; .045 g/g; g/g 13537-153_065f261c-4cdf-4c98-abce-66668713b2f5 13537-153 HUMAN OTC DRUG ESIKA PERFECT SUN Avobenzone, Octisalate, Octocrylene, and Oxybenzone LIQUID TOPICAL 20120124 OTC MONOGRAPH FINAL part352 Ventura Corporation, Ltd. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .1; .06 g/mL; g/mL; g/mL; g/mL 13537-154_9db5721c-2014-4a3a-b199-8aa88840145c 13537-154 HUMAN OTC DRUG ESIKA MEN MAXIMUM STRENGTH PYRITHIONE ZINC LIQUID TOPICAL 20120124 OTC MONOGRAPH FINAL part358H Ventura Corporation Ltd PYRITHIONE ZINC .00528 g/mL 13537-155_91282cc9-1792-4712-807f-fe2f8e53232f 13537-155 HUMAN OTC DRUG Cyzone SUN BY ME Sunblock SPF 50 OCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, TITANIUM DIOXIDE, and ENSULIZOLE CREAM TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .03; .075; .05; .07; .06; .0468 g/g; g/g; g/g; g/g; g/g; g/g 13537-156_15ca348a-baf0-49c1-95be-b737bcb836cf 13537-156 HUMAN OTC DRUG Esika TOTAL SEC ULTRA FRESH ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20120124 OTC MONOGRAPH FINAL part350 Ventura Corporation, Ltd. ALUMINUM SESQUICHLOROHYDRATE .0162 g/mL 13537-157_e8993a1e-d0d0-4120-997d-dfe8da088b59 13537-157 HUMAN OTC DRUG ESIKA Total Sec Delicate Skin ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20120124 OTC MONOGRAPH FINAL part350 Ventura Corporation, Ltd. ALUMINUM SESQUICHLOROHYDRATE .162 g/mL 13537-158_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-158 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROSE TENTATION) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-159_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-159 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROSE DELICAT) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-160_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-160 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (CARMINE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-161_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-161 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (NOBLESSE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-162_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-162 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (MALBEC) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-163_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-163 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (AMANDIER) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-164_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-164 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (SOBRIETE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-165_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-165 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (FIANCEE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-166_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-166 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROMANCE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-167_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-167 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROSE FUCSIA) - MAGENTA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-168_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-168 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (MIEL ECHANTER) - ORANGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-169_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-169 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (BLUSH CURE) - PINK Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .0003; .071; .0003; .02; .01 g/g; g/g; g/g; g/g; g/g 13537-170_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-170 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (GET WELL PEACH) - PINK Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .0003; .071; .0003; .02; .01 g/g; g/g; g/g; g/g; g/g 13537-171_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-171 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (PURE OXYGEN) - BEIGE Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .0003; .071; .0003; .02; .01 g/g; g/g; g/g; g/g; g/g 13537-172_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-172 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (SAND LIFE) - YELLOW Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .0003; .071; .0003; .02; .01 g/g; g/g; g/g; g/g; g/g 13537-173_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-173 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (CHOCO THERAPY) - BROWN Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .0003; .071; .0003; .02; .01 g/g; g/g; g/g; g/g; g/g 13537-174_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-174 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (INTENSIVE RED) - RED Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .0003; .071; .0003; .02; .01 g/g; g/g; g/g; g/g; g/g 13537-175_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-175 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (DR. ROSE) - PINK Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .0003; .071; .0003; .02; .01 g/g; g/g; g/g; g/g; g/g 13537-187_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-187 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 6) - BEIGE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-188_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-188 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 5) - BEIGE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-189_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-189 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 4) - BEIGE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-190_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-190 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 3) - BEIGE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-191_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-191 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 2) - BEIGE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-192_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-192 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 1) - BEIGE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-193_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-193 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 6) - ROSE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-194_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-194 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 5) - ROSE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-195_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-195 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 4) - ROSE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-196_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-196 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 3) - ROSE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-197_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-197 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 2) - ROSE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-198_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-198 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 1) - ROSE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-199_d8c0d739-fedf-497c-9967-21bd5b57f772 13537-199 HUMAN OTC DRUG ESIKA NATURAL CARE CONCHA DE NACAR AND ROSA MOSQUETA facial FPS 15 Octinoxate and Oxybenzone CREAM TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .045 g/g; g/g 13537-200_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-200 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 1) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL 13537-201_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-201 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 2) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL 13537-202_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-202 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 3) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL 13537-203_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-203 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 4) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL 13537-204_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-204 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 5) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL 13537-205_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-205 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 6) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL 13537-206_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-206 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 7) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL 13537-207_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-207 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (OBSCURE 8) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL 13537-208_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-208 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (OBSCURE 9) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL 13537-209_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-209 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Beige 1) - BEIGE Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g 13537-210_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-210 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Beige 2) - BEIGE Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g 13537-211_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-211 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Beige 3) - BEIGE Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g 13537-212_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-212 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Beige 4) - BEIGE Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g 13537-213_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-213 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Beige 5) - BEIGE Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g 13537-214_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-214 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Beige 6) - BEIGE Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g 13537-215_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-215 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Rosa 1) - PINK Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g 13537-216_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-216 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Rosa 2) - PINK Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g 13537-217_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-217 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Rosa 3) - PINK Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g 13537-218_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-218 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Rosa 4) - PINK Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g 13537-219_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-219 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Rosa 5) - PINK Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g 13537-220_11ff77dd-09ef-475a-99fb-db685389c6e6 13537-220 HUMAN OTC DRUG LBel Effet Parfait Rouge Volumesse Octinoxate and Oxybenzone LIPSTICK TOPICAL 20100815 OTC MONOGRAPH FINAL part352 VENTURA INTERNATIONAL LTD., OCTINOXATE; OXYBENZONE .2688; .0896 g/4g; g/4g 13537-221_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-221 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Rosa 6) - PINK Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g 13537-222_34efefdd-923c-46a2-b218-bf9d25b38856 13537-222 HUMAN OTC DRUG Cyzone Rock You Aluminum sesquichlorohydrate LIQUID TOPICAL 20111108 OTC MONOGRAPH FINAL part350 Ventura Corporation Limited ALUMINUM SESQUICHLOROHYDRATE 8.5 g/50mL 13537-224_497b3c05-d201-4c65-b76a-eb82e12a2926 13537-224 HUMAN OTC DRUG ESIKA PROTECTOR AGAINST SOLAR RAYS FOR CHILDREN, FACE AND BODY SPF 50 Ensulizole, Octinoxate, Octisalate, Octocrylene, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .03; .075; .05; .07; .06; .046 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL 13537-226_c7087e21-9827-48ae-a3e6-8d0f73b5755e 13537-226 HUMAN OTC DRUG LBEL LIP MOISTURIZER SPF 18 Octinoxate, Oxybenzone, and Titanium Dioxide LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .03; .08 g/g; g/g; g/g 13537-230_f1107067-ec96-4c76-9812-fa3ad7d196ce 13537-230 HUMAN OTC DRUG LBel Effet Parfit Octinoxate LOTION TOPICAL 20100815 OTC MONOGRAPH FINAL part352 VENTURA INTERNATIONAL LTD., OCTINOXATE 2.1 g/30mL 13537-240_80943940-f2b2-4589-8b16-ff202240fb7d 13537-240 HUMAN OTC DRUG LBEL EFFET PARFAIT OCTINOXATE and OXYBENZONE POWDER TOPICAL 20100816 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R.) OCTINOXATE; OXYBENZONE .075; .02 g/g; g/g 13537-241_4ada0382-be46-4796-9a67-ffdeda74907d 13537-241 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 1) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 13537-242_4ada0382-be46-4796-9a67-ffdeda74907d 13537-242 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 2) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 13537-243_4ada0382-be46-4796-9a67-ffdeda74907d 13537-243 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 3) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 13537-244_4ada0382-be46-4796-9a67-ffdeda74907d 13537-244 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 4) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 13537-245_4ada0382-be46-4796-9a67-ffdeda74907d 13537-245 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 5) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 13537-246_4ada0382-be46-4796-9a67-ffdeda74907d 13537-246 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 6) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 13537-247_4ada0382-be46-4796-9a67-ffdeda74907d 13537-247 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 7) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 13537-248_4ada0382-be46-4796-9a67-ffdeda74907d 13537-248 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 13537-249_4ada0382-be46-4796-9a67-ffdeda74907d 13537-249 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 9) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 13537-250_db7c5e24-7ccc-4eda-9c6e-b2bc4d6e2e2b 13537-250 HUMAN OTC DRUG LBel Effet Parfit Zinc oxide LOTION TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .48 g/30mL 13537-251_4ada0382-be46-4796-9a67-ffdeda74907d 13537-251 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 6B) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 13537-252_4ada0382-be46-4796-9a67-ffdeda74907d 13537-252 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8A) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 13537-253_4ada0382-be46-4796-9a67-ffdeda74907d 13537-253 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8B) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 13537-254_4ada0382-be46-4796-9a67-ffdeda74907d 13537-254 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8C) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 13537-255_4ada0382-be46-4796-9a67-ffdeda74907d 13537-255 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 10) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 13537-256_4ada0382-be46-4796-9a67-ffdeda74907d 13537-256 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (DORE 6) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 13537-257_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-257 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 1) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g 13537-258_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-258 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 2) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g 13537-259_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-259 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 3) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g 13537-260_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-260 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 4) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g 13537-261_c5dc0cbd-4b27-43dd-ab25-896c012a439a 13537-261 HUMAN OTC DRUG Supremacie NX Jour Ensulizole, Homosalate, Octinoxate, and Oxybenzone CREAM TOPICAL 20100219 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation, LTDA ENSULIZOLE; HOMOSALATE; OCTINOXATE; OXYBENZONE .001; .001; .00375; .002 g/5g; g/5g; g/5g; g/5g 13537-262_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-262 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 6) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g 13537-263_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-263 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 7) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g 13537-264_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-264 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (OBSCURE 8) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g 13537-265_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-265 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (OBSCURE 9) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g 13537-266_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-266 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 1) - BEIGE Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL 13537-267_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-267 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 2) - BEIGE Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL 13537-268_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-268 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 3)- BEIGE Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL 13537-269_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-269 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 4) - BEIGE Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL 13537-270_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-270 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 5) - BROWN Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL 13537-271_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-271 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 6) - BROWN Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL 13537-272_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-272 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 7) - BROWN Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL 13537-273_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-273 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (OBSCURE 8) - BROWN Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL 13537-274_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-274 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (OBSCURE 9) - BROWN Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL 13537-275_97cd7865-4cef-4561-86dd-e0429dbd50a4 13537-275 HUMAN OTC DRUG ESIKA Silk Skin SPF 9 (translucido) - BEIGE Octinoxate and Titanium Dioxide POWDER TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .02; .044 g/g; g/g 13537-276_97cd7865-4cef-4561-86dd-e0429dbd50a4 13537-276 HUMAN OTC DRUG ESIKA Silk Skin SPF 9 (terracota) - BEIGE Octinoxate and Titanium Dioxide POWDER TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .02; .044 g/g; g/g 13537-277_9e47161d-96ba-471f-8573-edb456612cd2 13537-277 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (BORGONA SEXY) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-278_9e47161d-96ba-471f-8573-edb456612cd2 13537-278 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (CAFE MOCA) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-280_9e47161d-96ba-471f-8573-edb456612cd2 13537-280 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (FUCSIA CAUTIVANTE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-281_9e47161d-96ba-471f-8573-edb456612cd2 13537-281 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (FUCSIA GLAM) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-282_9e47161d-96ba-471f-8573-edb456612cd2 13537-282 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (GRANATE SEDUCTOR) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-283_9e47161d-96ba-471f-8573-edb456612cd2 13537-283 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (MAGENTA TRAVIESA) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-284_9e47161d-96ba-471f-8573-edb456612cd2 13537-284 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (MARRON GLAMOUR) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-285_9e47161d-96ba-471f-8573-edb456612cd2 13537-285 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (MORADO EXUBERANTE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-286_9e47161d-96ba-471f-8573-edb456612cd2 13537-286 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (NARANJA PRIMAVERA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-287_9e47161d-96ba-471f-8573-edb456612cd2 13537-287 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (ROJO DESEO) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-288_9e47161d-96ba-471f-8573-edb456612cd2 13537-288 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (ROJO INTRIGANTE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-289_9e47161d-96ba-471f-8573-edb456612cd2 13537-289 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (ROJO LUJURIA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-290_9e47161d-96ba-471f-8573-edb456612cd2 13537-290 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (ROSA DIVA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-291_9e47161d-96ba-471f-8573-edb456612cd2 13537-291 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (ROSA ENCANTO) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-292_9e47161d-96ba-471f-8573-edb456612cd2 13537-292 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (ROSA ESPLENDOR) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-293_9e47161d-96ba-471f-8573-edb456612cd2 13537-293 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (ROSA ROMANTICA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-294_9e47161d-96ba-471f-8573-edb456612cd2 13537-294 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (CEREZA HECHIZO) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-295_9e47161d-96ba-471f-8573-edb456612cd2 13537-295 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (FRAMBUESA MANIA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-296_9e47161d-96ba-471f-8573-edb456612cd2 13537-296 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (ROSA DULZURA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-297_9e47161d-96ba-471f-8573-edb456612cd2 13537-297 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (PIMIENTA CALIENTE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-298_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-298 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 5) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g 13537-299_4ada0382-be46-4796-9a67-ffdeda74907d 13537-299 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 6A) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 13537-300_383c5b05-b1ce-4915-af8d-4e7ca45adb2c 13537-300 HUMAN OTC DRUG Cyzone better lips balm Octinoxate, Oxybenzone, and Zinc Oxide LIPSTICK TOPICAL 20110228 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; OXYBENZONE; ZINC OXIDE 70; 20; 10 mg/g; mg/g; mg/g 13537-301_240f3cbb-c4ce-4a40-9d08-4001f9893369 13537-301 HUMAN OTC DRUG Cyzone Trax Coolture Dermo Cool Pyrithione zinc LIQUID TOPICAL 20100815 OTC MONOGRAPH FINAL part358H VENTURA CORPORATION LTDA., PYRITHIONE ZINC 15 g/300mL 13537-303_498ee34c-a160-4d17-867b-4d9bc49314ca 13537-303 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g 13537-305_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-305 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL 13537-306_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-306 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL 13537-307_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-307 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL 13537-308_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-308 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL 13537-309_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-309 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL 13537-310_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-310 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL 13537-311_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-311 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL 13537-312_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-312 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL 13537-313_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-313 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL 13537-314_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-314 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL 13537-315_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-315 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL 13537-316_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-316 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL 13537-317_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-317 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g 13537-318_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-318 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g 13537-319_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-319 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g 13537-320_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-320 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g 13537-321_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-321 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g 13537-322_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-322 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g 13537-323_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-323 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g 13537-324_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-324 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g 13537-325_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-325 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g 13537-326_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-326 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g 13537-327_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-327 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g 13537-328_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-328 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g 13537-329_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-329 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-330_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-330 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-331_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-331 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-332_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-332 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-333_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-333 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-334_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-334 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-335_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-335 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-336_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-336 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-337_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-337 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-338_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-338 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-339_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-339 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-340_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-340 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g 13537-341_1b7b4e9b-b2a0-4960-b2c4-a725243f27d4 13537-341 HUMAN OTC DRUG ESIKA Men Effective Control Pyrithione Zinc LIQUID TOPICAL 20110517 OTC MONOGRAPH FINAL part358H Ventura Corporation (San Juan, P.R) PYRITHIONE ZINC .0036 mg/mL 13537-342_8c2d556d-adaa-401b-a7cb-7fe07e96875f 13537-342 HUMAN OTC DRUG ESIKA Men Multi-Action 2-in-1 Pyrithione Zinc LIQUID TOPICAL 20110517 OTC MONOGRAPH FINAL part358H Ventura Corporation (San Juan, P.R) PYRITHIONE ZINC .011 mg/mL 13537-343_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-343 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g 13537-344_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-344 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g 13537-345_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-345 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g 13537-346_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-346 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g 13537-347_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-347 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g 13537-348_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-348 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g 13537-349_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-349 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g 13537-350_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-350 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g 13537-351_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-351 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g 13537-352_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-352 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g 13537-353_0ec8a72b-c0ca-4210-ac5d-14139563b670 13537-353 HUMAN OTC DRUG ESIKA Vital With Active Z 2-in-1 Dandruff Control Pyrithione Zinc LIQUID TOPICAL 20110517 OTC MONOGRAPH FINAL part358H Ventura Corporation (San Juan, P.R) PYRITHIONE ZINC .0034 mg/mL 13537-354_96e1af13-e5a8-48c9-95a5-ab705566d9da 13537-354 HUMAN OTC DRUG Esika Silk Skin Translucido OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20110724 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; TITANIUM DIOXIDE .02; .044 g/g; g/g 13537-355_96e1af13-e5a8-48c9-95a5-ab705566d9da 13537-355 HUMAN OTC DRUG Esika Silk Skin Terracota OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20110724 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; TITANIUM DIOXIDE .02; .044 g/g; g/g 13537-356_02ba31a3-df90-4aa8-904f-ab24c6bc82f2 13537-356 HUMAN OTC DRUG Cyzone Express Your Face Octinoxate and Oxybenzone CREAM TOPICAL 20110527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .055; .04 g/g; g/g 13537-359_156122c9-649f-4d7a-b71d-42fe937bf860 13537-359 HUMAN OTC DRUG CYZONE BLUE AND BLUE FOR HER Aluminum Sesquichlorohydrate LIQUID TOPICAL 20110527 OTC MONOGRAPH FINAL part350 Ventura Corporation (San Juan, P.R) ALUMINUM SESQUICHLOROHYDRATE .17 mL/mL 13537-360_88945b2c-eaac-4856-b774-1cc588053590 13537-360 HUMAN OTC DRUG CYZONE BLUE AND BLUE FOR HIM Aluminum Sesquichlorohydrate LIQUID TOPICAL 20110527 OTC MONOGRAPH FINAL part350 Ventura Corporation (San Juan, P.R) ALUMINUM SESQUICHLOROHYDRATE .17 mL/mL 13537-361_0503c196-a28d-44ef-95ca-86d73a1f8ab6 13537-361 HUMAN OTC DRUG CYZONE GIRLINK Aluminum Sesquichlorohydrate LIQUID TOPICAL 20110527 OTC MONOGRAPH FINAL part350 Ventura Corporation (San Juan, P.R) ALUMINUM SESQUICHLOROHYDRATE .17 mL/mL 13537-362_a38898e8-c86e-4018-a386-fba649701ac0 13537-362 HUMAN OTC DRUG CYZONE NITRO DESODORANTE ANTITRANSPIRANTE ROLL ON Aluminum Sesquichlorohydrate LIQUID TOPICAL 20110527 OTC MONOGRAPH FINAL part350 Ventura Corporation (San Juan, P.R) ALUMINUM SESQUICHLOROHYDRATE .17 mL/mL 13537-363_cb0de263-166f-4688-a85d-8f7f1418cf95 13537-363 HUMAN OTC DRUG ESIKA Perfect Sun Kids ENSULIZOLE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20110530 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .03; .075; .05; .07; .6; .0468 g/g; g/g; g/g; g/g; g/g; g/g 13537-364_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-364 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g 13537-365_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-365 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g 13537-366_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-366 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g 13537-367_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-367 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g 13537-368_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-368 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g 13537-369_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-369 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g 13537-370_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-370 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g 13537-371_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-371 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g 13537-372_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-372 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g 13537-373_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-373 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g 13537-374_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-374 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g 13537-379_9e47161d-96ba-471f-8573-edb456612cd2 13537-379 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (CORAL CHIC) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-400_ff56bc19-d229-4169-94ba-c9d62b1b9831 13537-400 HUMAN OTC DRUG Cyzone Be Sexy BS Tech Zinc Pyrithione And Silicones Pyrithione Zinc LOTION TOPICAL 20111213 OTC MONOGRAPH FINAL part358H Ventura Corporation Ltd. PYRITHIONE ZINC .0036 mg/mL 13537-401_1369a773-beb9-4ad3-86fa-3f74118d9694 13537-401 HUMAN OTC DRUG Cyzone Trax Coolture Dermo Cool Aluminum sesquichlorohydrate LIQUID TOPICAL 20100815 OTC MONOGRAPH FINAL part350 VENTURA CORPORATION LTDA. ALUMINUM SESQUICHLOROHYDRATE 10 g/50mL 13537-402_38b1a1b0-a33d-404c-8214-b9cbf57a478c 13537-402 HUMAN OTC DRUG LBEL UV DEFENSE 365 Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20110829 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. (San Juan, P.R) HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE .05; .07; .05; .04; .0624; .0388 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL 13537-403_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-403 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (CLAIRE 3) - BEIGE Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g 13537-404_7d3d469b-73f4-4516-9a5a-524698888c6f 13537-404 HUMAN OTC DRUG LBEL Dermo Clarite Clarifying and Moisturizing with SPF 30 Avobenzone, Ensulizole, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20111213 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .03; .05; .05; .06 g/mL; g/mL; g/mL; g/mL; g/mL 13537-405_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-405 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (MEDIUM 5) - BROWN Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g 13537-406_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-406 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (MEDIUM 6) - BROWN Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g 13537-407_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-407 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (MEDIUM 7) - BROWN Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g 13537-408_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-408 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (OBSCURE 8) - BROWN Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g 13537-409_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-409 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (OBSCURE 9) - BROWN Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g 13537-410_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-410 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (MARRON ILLIMITE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-411_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-411 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (CHOCOLAT MAJESTIC) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-412_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-412 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (CORAIL MAXIMUM) - ORANGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-413_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-413 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (FUCSIA SPLENDIDE) - MAGENTA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-414_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-414 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROUGE PRODIGEUX) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-415_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-415 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROUGE GRANDOISE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-416_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-416 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROSE CHAMPAGNE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-417_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-417 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROSE DAMOUR) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-418_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-418 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROUGE RUBI) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-419_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-419 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (SAUMON ESSENTIEL) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-420_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-420 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (BOURGOGNE VIF) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-421_d63b13c9-1bd6-4a48-85f7-bb27666a0d31 13537-421 HUMAN OTC DRUG ESIKA MOMENTOS Libertad Roll-on Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-422_3eafe939-8cba-456c-a0d3-fdacfd9bdc19 13537-422 HUMAN OTC DRUG ESIKA ELANIE Roll-on Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-423_eb81fc06-f1b5-4b52-a31a-24260828ab45 13537-423 HUMAN OTC DRUG ESIKA EXPRESSION Roll-on Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL 13537-425_741fd278-d4b2-4cad-85f5-f0440d22c1e7 13537-425 HUMAN OTC DRUG LBEL DRY EFFECT 48 ROLL-ON Aluminum Sesquichlorohydrate LIQUID TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .18 g/mL 13537-426_9122ddf2-99a7-4150-bea1-c2acfac0a2d4 13537-426 HUMAN OTC DRUG LBEL HOMME ANTIDANDRUFF Pyrithione Zinc SHAMPOO TOPICAL 20120120 OTC MONOGRAPH FINAL part358H Ventura Corporation Ltd PYRITHIONE ZINC .00336 g/mL 13537-427_288b1855-af20-4d47-adb8-ad8c8c81bb97 13537-427 HUMAN OTC DRUG LBEL DRY EFFECT 48 ALUMINUM CHLOROHYDRATE AEROSOL, SPRAY TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd ALUMINUM CHLOROHYDRATE .24 g/mL 13537-428_7fffe85d-18fd-4084-bedb-4c1209bacd7b 13537-428 HUMAN OTC DRUG LBEL Effet Parfait maximum comfort and long-lasting foundation spf 10 Zinc Oxide LOTION TOPICAL 20120210 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. ZINC OXIDE .0157 g/mL 13537-429_0eb84e4a-3045-45d5-9c6c-21451962ca62 13537-429 HUMAN OTC DRUG CYZONE XPRESS YOUR BODY Aluminum Sesquichlorohydrate LIQUID TOPICAL 20120608 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .2 g/mL 13537-430_d824f125-45f3-4096-aecc-76467482ba08 13537-430 HUMAN OTC DRUG CYZONE XPRESS YOUR BODY Aluminum Sesquichlorohydrate LIQUID TOPICAL 20120608 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .2 g/mL 13537-431_e82a4522-6688-4512-997b-643c769aaf05 13537-431 HUMAN OTC DRUG CYZONE XPRESS YOUR BODY Sensitive Aluminum Sesquichlorohydrate LIQUID TOPICAL 20120608 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .2 g/mL 13537-432_bfaef6ff-f605-4ff9-9006-2cc44d48e0ca 13537-432 HUMAN OTC DRUG CYZONE CY PERLIPS Labial Hidratante con perlas de luz y FPS 20 Octinoxate and Oxybenzone CREAM TOPICAL 20120713 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g 13537-433_692ca820-02d3-4008-a6d4-d0ee158731c8 13537-433 HUMAN OTC DRUG CYZONE CY SOLUXION desmanchadora FPS 15 Octinoxate and Oxybenzone CREAM TOPICAL 20120713 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .075; .045 g/g; g/g 13537-434_928b87c9-da1d-4633-a52f-b0d29642eeef 13537-434 HUMAN OTC DRUG LBEL EFFET PARFAIT Signs of age appearance minimizer foundation SPF 20 Octinoxate and Titanium Dioxide LOTION TOPICAL 20120914 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; TITANIUM DIOXIDE .07; .024 g/mL; g/mL 13537-435_b82ef368-8abd-47cf-8a63-40fc66b84bf6 13537-435 HUMAN OTC DRUG CYZONE SUN BY ME FACE SCREEN FPS 50 AMPLIO ESPECTRO Octinoxate, Octocrylene, Oxybenzone, Octisalate, Titanium Dioxide, and Ensulizole CREAM TOPICAL 20120914 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .03; .075; .05; .07; .06; .468 g/g; g/g; g/g; g/g; g/g; g/g 13537-436_ec45b9a5-94e1-4965-98e6-12d919e49eb1 13537-436 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20120914 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-437_c8a8893b-0e0d-49c6-bdad-19f9f43fc343 13537-437 HUMAN OTC DRUG esika HIGHWAY Roll-on Aluminum Sesquichlorohydrate LIQUID TOPICAL 20130201 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .136 g/mL 13537-438_3c94bf7f-1faa-4327-a7be-ed84946fd04f 13537-438 HUMAN OTC DRUG esika D ARIEN CLASS Roll-on Aluminum Sesquichlorohydrate LIQUID TOPICAL 20130201 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .136 g/mL 13537-439_e1dac717-a94d-417d-97f1-c0414ff62c8f 13537-439 HUMAN OTC DRUG esika BEAUTY RED Roll-on Aluminum Sesquichlorohydrate LIQUID TOPICAL 20130201 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .136 g/mL 13537-440_d62bee35-45db-4f74-b7f7-3697e719d4db 13537-440 HUMAN OTC DRUG esika SPECIAL Roll-on Aluminum Sesquichlorohydrate LIQUID TOPICAL 20130215 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .136 g/mL 13537-441_40868e7e-0f20-4be9-b570-391b765a7a99 13537-441 HUMAN OTC DRUG esika MEN Control Fresh Deodorant and Antiperspirant Aluminum Chlorohydrate LIQUID TOPICAL 20121204 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM CHLOROHYDRATE .045 g/mL 13537-442_4d4265eb-7fd5-4e3c-9212-d5832bbbba4d 13537-442 HUMAN OTC DRUG esika Maximum Color Lipstick SPF 18 OCTINOXATE and Oxybenzone LIPSTICK TOPICAL 20121206 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g 13537-443_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-443 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (MOKA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-444_060cde89-bd6f-4fb3-ba3b-d62ac7ec04d3 13537-444 HUMAN OTC DRUG LBEL LEDERM 35plus Jour SPF 15 Facial Treatment Against First Signs of Aging Day - Oily Skin Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g 13537-445_a2d166f7-69ae-42e5-9f3c-46c34ec0f739 13537-445 HUMAN OTC DRUG LBEL LEDERM 35plus Jour SPF 15 Facial Treatment Against First Signs of Aging Day - Normal to Dry Skin Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g 13537-446_d4b3adc7-bef7-44fa-ba11-c40f23b7fbd5 13537-446 HUMAN OTC DRUG LBEL LEDERM 45plus Jour SPF 15 Facial Treatment Against Noticeable Signs of Aging Day - Oily Skin Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g 13537-447_ac3d4876-f64f-4f61-8586-ba18729f7666 13537-447 HUMAN OTC DRUG LBEL LEDERM 45plus Jour SPF 15 Facial Treatment Against Noticeable Signs of Aging Day - Normal to Dry Skin Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g 13537-448_4b1995b6-09c5-4828-8f20-3d972ca007d0 13537-448 HUMAN OTC DRUG LBEL LEDERM 55plus Jour SPF 15 Facial Treatment Against Advanced Signs of Aging Day - All Skin Types Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g 13537-449_c0d42f77-a9ac-4d0b-967a-91b8d868ed4e 13537-449 HUMAN OTC DRUG CYZONE CY SOLUXION Aclaradora FPS 15 Octinoxate and Oxybenzone CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .075; .045 g/g; g/g 13537-450_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-450 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 COFFEE SWEET Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g 13537-451_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-451 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 ROSA BELLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g 13537-452_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-452 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 DURAZNO GLAM Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g 13537-453_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-453 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 ROSA CANDY Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g 13537-454_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-454 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 CORAL SEDUCTION Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g 13537-455_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-455 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 CHERRY CLASS Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g 13537-456_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-456 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 RED SUPREME Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g 13537-457_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-457 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 VINO MIDNIGHT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g 13537-458_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-458 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 FUCSIA FEMME Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g 13537-459_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-459 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 CEREZA DEEP Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g 13537-460_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-460 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (FUXIA DEFENSE) - MAGENTA Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .0003; .071; .0003; .02; .01 g/g; g/g; g/g; g/g; g/g 13537-461_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-461 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (GRAPE CARE) - RED Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .0003; .071; .0003; .02; .01 g/g; g/g; g/g; g/g; g/g 13537-462_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-462 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (FLASHY KARMIN) - RED Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .0003; .071; .0003; .02; .01 g/g; g/g; g/g; g/g; g/g 13537-463_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-463 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (PINK STAR) - PINK Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .0003; .071; .0003; .02; .01 g/g; g/g; g/g; g/g; g/g 13537-464_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-464 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (LILAC ZIMMER) - LILAC Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .0003; .071; .0003; .02; .01 g/g; g/g; g/g; g/g; g/g 13537-465_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-465 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (SHINY BROWN) - BROWN Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .0003; .071; .0003; .02; .01 g/g; g/g; g/g; g/g; g/g 13537-466_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-466 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (SUN LIGHT) - BEIGE Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .0003; .071; .0003; .02; .01 g/g; g/g; g/g; g/g; g/g 13537-467_2156c7d0-09a6-4f68-84b7-a2442b799fd9 13537-467 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (PECHE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL 13537-468_2156c7d0-09a6-4f68-84b7-a2442b799fd9 13537-468 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (GRAPE LUMIERE) - MAGENTA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL 13537-469_2156c7d0-09a6-4f68-84b7-a2442b799fd9 13537-469 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (SWEET FRAMBOISE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL 13537-470_2156c7d0-09a6-4f68-84b7-a2442b799fd9 13537-470 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (DOUCE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL 13537-471_2156c7d0-09a6-4f68-84b7-a2442b799fd9 13537-471 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (VIN) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL 13537-472_2156c7d0-09a6-4f68-84b7-a2442b799fd9 13537-472 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (CARAMEL MELON) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL 13537-473_2156c7d0-09a6-4f68-84b7-a2442b799fd9 13537-473 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (GROSEILLE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL 13537-474_2156c7d0-09a6-4f68-84b7-a2442b799fd9 13537-474 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (VIN SENSUELLE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL 13537-490_e591ae1e-efb0-4f7c-9e19-f2651652caf7 13537-490 HUMAN OTC DRUG esika MAX ANTIPERSPIRANT ROLL-ON DEODORANT Aluminum Sesquichlorohydrate LIQUID TOPICAL 20130527 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .136 g/mL 13537-491_d43080da-f846-4bd5-aab7-837c75ea3f4a 13537-491 HUMAN OTC DRUG CYZONE FLIRTY GIRL DESODORANTE ANTITRANSPIRANTE ROLL-ON no contiene alcohol Aluminum Sesquichlorohydrate LIQUID TOPICAL 20130527 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .136 g/mL 13537-492_9916ab3c-1ab5-4794-a5f3-4ecb5649899b 13537-492 HUMAN OTC DRUG CYZONE ATTRAK DESODORANTE ANTITRANSPIRANTE ROLL-ON no contiene alcohol Aluminum Sesquichlorohydrate LIQUID TOPICAL 20130527 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .136 g/mL 13537-493_d559a821-7a1b-4251-9f9f-c69daf4542d4 13537-493 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Claire 1-2-3 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 13537-494_d559a821-7a1b-4251-9f9f-c69daf4542d4 13537-494 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Claire 4 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 13537-495_d559a821-7a1b-4251-9f9f-c69daf4542d4 13537-495 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Medium 5 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 13537-496_d559a821-7a1b-4251-9f9f-c69daf4542d4 13537-496 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Medium 6 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 13537-497_d559a821-7a1b-4251-9f9f-c69daf4542d4 13537-497 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Medium 7 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 13537-498_d559a821-7a1b-4251-9f9f-c69daf4542d4 13537-498 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Obscure 8-9 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 13537-499_f47034d3-848d-41e3-96c5-e843b3f37367 13537-499 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Claire 1-2-3 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 13537-500_f47034d3-848d-41e3-96c5-e843b3f37367 13537-500 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Claire 4 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 13537-501_f47034d3-848d-41e3-96c5-e843b3f37367 13537-501 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Medium 5 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 13537-502_f47034d3-848d-41e3-96c5-e843b3f37367 13537-502 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Medium 6 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 13537-503_f47034d3-848d-41e3-96c5-e843b3f37367 13537-503 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Medium 7 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 13537-504_f47034d3-848d-41e3-96c5-e843b3f37367 13537-504 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Obscure 8-9 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 13537-505_25e9c97b-57e7-4f2f-b59c-014a106c0712 13537-505 HUMAN OTC DRUG esika total sec DELICATE SKIN Alcohol Free Womens Deodorant and Antiperspirant - All day protection Aluminum Chlorohydrate SPRAY TOPICAL 20130527 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM CHLOROHYDRATE .045 g/mL 13537-506_38a0e8f3-e2dc-428e-934d-4e4b0ef303dd 13537-506 HUMAN OTC DRUG esika total sec NEUTRAL FRAGRANCE Alcohol Free Unisex Deodorant and Antiperspirant - All day protection Aluminum Chlorohydrate SPRAY TOPICAL 20130527 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM CHLOROHYDRATE .045 g/mL 13537-511_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-511 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - MOKA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-512_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-512 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ROMANCE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-513_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-513 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ROSE NATURAL Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-514_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-514 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ROSE CLASIQUE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-515_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-515 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ROUGE INTENSE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-516_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-516 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - AMOUR Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-517_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-517 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - CHOCOLAT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-518_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-518 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ALMOND Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-519_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-519 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - MALVE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-520_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-520 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - MARRON GLACE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-521_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-521 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - TULIP Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-522_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-522 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - NUDE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-523_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-523 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - LILY BEIGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-524_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-524 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - MANDARINE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-525_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-525 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - VIN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-526_a79a2640-f02d-4733-afab-cbe61b2043cc 13537-526 HUMAN OTC DRUG esika JADISS Glam Antiperspirant Roll-on Deodorant Aluminum Sesquichlorohydrate LIQUID TOPICAL 20130527 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .136 g/mL 13537-527_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-527 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE CHAMPAGNE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-528_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-528 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - FUCSIA SPLENDIDE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-529_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-529 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE DAMOUR Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-530_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-530 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE FORMIDABLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-531_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-531 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - NATURAL PERSISTANT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-532_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-532 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - MIEL ECHANTER Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-533_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-533 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE PRODIGEUX Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-534_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-534 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - MARRON ILLIMITE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-535_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-535 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - CHOCOLAT MAJESTIC Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-536_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-536 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - CAFE SUCCES Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-537_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-537 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE GRANDOISE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-538_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-538 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE RUBI Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-539_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-539 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - SAUMON ESSENTIEL Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-540_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-540 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - BOURGOGNE VIF Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-541_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-541 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - VIOLET POURPRE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-542_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-542 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - CORAIL MAXIMUM Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-543_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-543 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ORANGE DELIRANT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-544_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-544 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE INTENSE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-545_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-545 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE FEMME Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-546_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-546 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - DORE CHOCOLAT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-547_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-547 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - MER DE ROSES Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-548_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-548 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE TENTATION Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-549_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-549 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE DELICAT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-550_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-550 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - FUCSIA DESIR Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-551_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-551 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE PROVOCATION Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-552_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-552 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - AMPLIFFIER AMANDIER Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-553_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-553 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - SOBRIETE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-554_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-554 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - FIANCEE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-555_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-555 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROMANCE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-556_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-556 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - CARMINE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-557_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-557 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - NOBLESSE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-558_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-558 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - MALBEC Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-559_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-559 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE FUCSIA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 13537-560_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-560 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - CLAIRE 1 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL 13537-561_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-561 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - CLAIRE 2 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL 13537-562_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-562 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - CLAIRE 3 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL 13537-563_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-563 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - CLAIRE 4 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL 13537-564_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-564 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - MEDIUM 5 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL 13537-565_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-565 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - MEDIUM 6 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL 13537-566_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-566 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - MEDIUM 7 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL 13537-567_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-567 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - OBSCURE 8 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL 13537-568_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-568 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - OBSCURE 9 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL 13537-570_a2aaa07b-d6c5-4f4a-9b5d-0d9c40ae91a5 13537-570 HUMAN OTC DRUG LBEL EFFET PARFAIT DUAL-USE COMPACT YOUTHFUL LOOKING SKIN SPF7 Titanium Dioxide POWDER TOPICAL 20130916 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. TITANIUM DIOXIDE .05 g/g 13537-600_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-600 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (CLAIRE 1) - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 13537-601_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-601 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (CLAIRE 2) - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 13537-602_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-602 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (CLAIRE 3) - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 13537-603_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-603 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (CLAIRE 4) - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 13537-604_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-604 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (MEDIUM 5) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 13537-605_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-605 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (MEDIUM 6) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 13537-606_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-606 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (MEDIUM 7) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 13537-607_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-607 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (OBSCURE 8) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 13537-608_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-608 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (OBSCURE 9) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 13537-870_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-870 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROUGE GRANDIOSE) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-871_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-871 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROUGE RUBI) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-872_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-872 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (SOBRIETE) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-873_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-873 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (MARRON ILIMITEE) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-874_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-874 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (CORAL MAXIMUM) - ORANGE OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-875_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-875 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROSE TENTATION) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-876_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-876 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROSE CHAMPAGNE) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-877_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-877 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROSE DAMOUR) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-878_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-878 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROMANCE) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-879_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-879 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (FUCSIA SPLENDIDE) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-881_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-881 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (FUCSIA DESIR) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-882_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-882 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROUGE PROVOCATION) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-883_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-883 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (CARMINE) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-884_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-884 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (MALBEC) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-885_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-885 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (SALMON ESSENTIAL) - ORANGE OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-887_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-887 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (BOURGOGNE VIF) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-888_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-888 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (GENUINE ROUGE) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-889_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-889 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (VIOLET VELVET) - PURPLE OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-890_73f2219f-202f-40ba-9c4a-ecafe99d8d39 13537-890 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (MYSTIC ROSE) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g 13537-891_1a5fda67-78a1-436c-bf44-42c32031e809 13537-891 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MOKA) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-892_1a5fda67-78a1-436c-bf44-42c32031e809 13537-892 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROMANCE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-893_1a5fda67-78a1-436c-bf44-42c32031e809 13537-893 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROSE NATURAL) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-894_1a5fda67-78a1-436c-bf44-42c32031e809 13537-894 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROSE CLASIQUE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-895_1a5fda67-78a1-436c-bf44-42c32031e809 13537-895 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROUGE INTENSE) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-896_1a5fda67-78a1-436c-bf44-42c32031e809 13537-896 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (AMOUR) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-897_1a5fda67-78a1-436c-bf44-42c32031e809 13537-897 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (CHOCOLAT) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-898_1a5fda67-78a1-436c-bf44-42c32031e809 13537-898 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ALMOND) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-899_1a5fda67-78a1-436c-bf44-42c32031e809 13537-899 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MALVE) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-900_1a5fda67-78a1-436c-bf44-42c32031e809 13537-900 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MARRON GLACE) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-901_f1dbc221-70bf-4d21-96ca-701a487185c6 13537-901 HUMAN OTC DRUG LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 Octinoxate, Titanium Dioxide, Homosalate, Octisalate, Oxybenzone, and Zinc Oxide LOTION TOPICAL 20141014 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE .05; .07; .05; .04; .062; .039 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL 13537-902_1a5fda67-78a1-436c-bf44-42c32031e809 13537-902 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (TULIP) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-903_1a5fda67-78a1-436c-bf44-42c32031e809 13537-903 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (LILY BEIGE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-904_1a5fda67-78a1-436c-bf44-42c32031e809 13537-904 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MANDARINE) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-905_1a5fda67-78a1-436c-bf44-42c32031e809 13537-905 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (VIN) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-906_1a5fda67-78a1-436c-bf44-42c32031e809 13537-906 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (TEA ROSE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-907_1a5fda67-78a1-436c-bf44-42c32031e809 13537-907 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (FRENESIE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-908_1a5fda67-78a1-436c-bf44-42c32031e809 13537-908 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (RICHE PINK) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-909_1a5fda67-78a1-436c-bf44-42c32031e809 13537-909 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (RED EXTASSY) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-910_1a5fda67-78a1-436c-bf44-42c32031e809 13537-910 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (FUCSIA) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-911_1a5fda67-78a1-436c-bf44-42c32031e809 13537-911 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (SOLEIL) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-912_1a5fda67-78a1-436c-bf44-42c32031e809 13537-912 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (TERRE) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-913_1a5fda67-78a1-436c-bf44-42c32031e809 13537-913 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (CHERRY BLOSSOM) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-914_1a5fda67-78a1-436c-bf44-42c32031e809 13537-914 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (VIN AMANT) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-915_1a5fda67-78a1-436c-bf44-42c32031e809 13537-915 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE INTIME) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-916_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-916 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (MARRON GLAMOUR) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-917_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-917 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROJO DESEO) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-918_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-918 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROJO INTRIGANTE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-919_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-919 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROJO LUJURIA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-920_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-920 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (CORAL CHIC) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-921_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-921 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ENCANTO) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-922_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-922 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (BORGONA SEXY) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-923_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-923 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (FUCSIA CAUTIVANTE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-924_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-924 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (GRANATE SEDUCTOR) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-925_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-925 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ROMANTICA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-926_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-926 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (NARANJA PRIMAVERA) - ORANGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-927_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-927 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (FRAMBUESA MANIA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-928_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-928 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA DULZURA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-929_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-929 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (PIMIENTA CALIENTE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-930_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-930 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (CANELA NUDE) - ORANGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-931_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-931 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (MORA GLAM) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-932_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-932 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (CORAL INTENSE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-933_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-933 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (FRESA COQUETA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-934_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-934 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (PIMIENTA CALIENTE FEMME) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-935_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-935 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (GRANATE SEDUCTOR FEMME) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-936_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-936 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (FUCSIA CAUTIVANTE FEMME) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-937_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-937 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ROMANTICA FEMME) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-938_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-938 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROJO INTRIGANTE FEMME) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-939_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-939 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ENCANTO FEMME) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g 13537-940_1a5fda67-78a1-436c-bf44-42c32031e809 13537-940 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 13537-998_30e22a5f-1790-45f5-af6a-7b815b50acf1 13537-998 HUMAN OTC DRUG ESIKA TRIPLE ACCION MAX BB Dark Beige Zinc Oxide and Octinoxate CREAM TOPICAL 20140310 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .07; .084 g/g; g/g 13537-999_30e22a5f-1790-45f5-af6a-7b815b50acf1 13537-999 HUMAN OTC DRUG ESIKA TRIPLE ACCION MAX BB Light Beige Zinc Oxide and Octinoxate CREAM TOPICAL 20140310 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .07; .084 g/g; g/g 13548-010_dc96e666-3d8b-43a6-8f35-9f5a93420a51 13548-010 HUMAN PRESCRIPTION DRUG Salex Salicylic acid CREAM TOPICAL 20040601 UNAPPROVED DRUG OTHER Coria Laboratories SALICYLIC ACID 60 mg/g 13548-011_dc96e666-3d8b-43a6-8f35-9f5a93420a51 13548-011 HUMAN PRESCRIPTION DRUG Salex Salicylic acid LOTION TOPICAL 20041001 UNAPPROVED DRUG OTHER Coria Laboratories SALICYLIC ACID 60 mg/mL 13548-012_dc96e666-3d8b-43a6-8f35-9f5a93420a51 13548-012 HUMAN PRESCRIPTION DRUG Salex Salicylic acid SHAMPOO TOPICAL 20041001 UNAPPROVED DRUG OTHER Coria Laboratories SALICYLIC ACID 60 mg/mL 13548-030_e4d1b280-d9cd-467b-af0a-1227bb087bbf 13548-030 HUMAN PRESCRIPTION DRUG Akne-mycin erythromycin OINTMENT TOPICAL 19850110 20150630 NDA NDA050584 CORIA LABORATORIES ERYTHROMYCIN 20 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 13548-031_61c77522-90c3-4fd3-a189-a9b779e30318 13548-031 HUMAN PRESCRIPTION DRUG Cloderm clocortolone pivalate CREAM TOPICAL 19770822 NDA NDA017765 Coria Laboratories CLOCORTOLONE PIVALATE .001 g/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 13548-070_968a1448-b199-4876-ab06-062ca27ed67f 13548-070 HUMAN PRESCRIPTION DRUG Atralin Tretinoin GEL TOPICAL 20070726 NDA NDA022070 Coria Laboratories TRETINOIN .05 g/100g Retinoid [EPC],Retinoids [Chemical/Ingredient] 13548-132_9844cde1-d0ea-4104-be70-e73ddd71522f 13548-132 HUMAN PRESCRIPTION DRUG ACANYA Clindamycin Phosphate and Benzoyl Peroxide GEL TOPICAL 20100726 NDA NDA050819 Coria Laboratories BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 25; 10 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 13548-638_5fc3e595-14ec-47cb-9357-d3ca037d69ff 13548-638 HUMAN PRESCRIPTION DRUG Refissa Tretinoin CREAM TOPICAL 20110201 ANDA ANDA076498 Coria Laboratories, LTD TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 13551-101_88f57d96-915a-4a3a-9c71-9fcce36159bb 13551-101 HUMAN PRESCRIPTION DRUG Karbinal ER Carbinoxamine Maleate SUSPENSION, EXTENDED RELEASE ORAL 20140103 NDA NDA022556 FSC Laboratories, Inc CARBINOXAMINE MALEATE 4 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 13551-205_8f36a957-8129-4f69-a57f-b60d485e04f8 13551-205 HUMAN PRESCRIPTION DRUG AcipHex Sprinkle rabeprazole sodium CAPSULE, DELAYED RELEASE ORAL 20141001 NDA NDA204736 FSC Laboratories, Inc. RABEPRAZOLE SODIUM 5 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 13551-210_8f36a957-8129-4f69-a57f-b60d485e04f8 13551-210 HUMAN PRESCRIPTION DRUG AcipHex Sprinkle rabeprazole sodium CAPSULE, DELAYED RELEASE ORAL 20141001 NDA NDA204736 FSC Laboratories, Inc. RABEPRAZOLE SODIUM 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 13551-501_0cc7d685-5819-4103-b667-375e23299dd8 13551-501 HUMAN PRESCRIPTION DRUG Primsol trimethoprim hydrochloride SOLUTION ORAL 20000124 NDA NDA074973 FSC Laboratories, Inc TRIMETHOPRIM HYDROCHLORIDE 50 mg/5mL Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 13551-701_fc4bf594-67d6-4daa-8f7a-efc43a964da4 13551-701 HUMAN PRESCRIPTION DRUG ProCentra dextroamphetamine sulfate LIQUID ORAL 20100801 ANDA ANDA040776 FSC Laboratories, Inc DEXTROAMPHETAMINE SULFATE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 13630-0008_9ab6493c-3abe-4c20-aad8-c03c2d403263 13630-0008 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 4 Avobenzone, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120321 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 4.03; 8.06; 4.03 mg/mL; mg/mL; mg/mL 13630-0012_79c0062f-91f0-4179-9880-e1ee11c4fa00 13630-0012 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120118 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 16.6; 62.3; 41.6; 22.9; 16.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0013_a6091ccd-8043-4cc1-a285-0f71ee21c422 13630-0013 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120103 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 16.9; 63.3; 42.2; 23.2; 16.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0014_669dfd50-24a4-4bd0-9962-39dc675eaf4f 13630-0014 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120410 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.4; 84.7; 42.4; 23.3; 33.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0015_da5ea691-6561-4c28-9fd4-517e370bd761 13630-0015 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120410 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.4; 84.7; 42.4; 23.3; 33.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0016_d658ea22-6c45-46e6-ba6b-62e181d0d0db 13630-0016 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20111101 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 16.7; 62.6; 41.8; 22.9; 16.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0017_77c86c57-70fe-4aff-b0b5-275e92416947 13630-0017 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, and Octocrylene SPRAY TOPICAL 20121027 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.2; 40.5; 22.3 mg/mL; mg/mL; mg/mL 13630-0018_652e8319-c760-439d-8afc-853bcd04d4dd 13630-0018 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20120614 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.4; 84.7; 42.4; 23.3; 33.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0019_3c05c254-92a5-4470-972e-df2d53f196ca 13630-0019 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 4 Avobenzone, Octocrylene and Oxybenzone SPRAY TOPICAL 20131215 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 8.4; 7.1; 4.2 mg/mL; mg/mL; mg/mL 13630-0020_da41b578-3338-47c9-86ce-be015c55b740 13630-0020 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 8 Avobenzone, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20131023 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 8.4; 25.1; 7.2; 8.4 mg/mL; mg/mL; mg/mL; mg/mL 13630-0021_d3e3c89b-099b-4ea4-8ee8-a6bd56a67c9d 13630-0021 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene SPRAY TOPICAL 20131215 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.8; 42; 15.5 mg/mL; mg/mL; mg/mL 13630-0022_46ce6a33-7cb7-4921-aeac-0eb3336ced5e 13630-0022 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene SPRAY TOPICAL 20131031 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.3; 40.7; 15 mg/mL; mg/mL; mg/mL 13630-0023_96cb63db-bbf3-4315-bd86-d388ef089849 13630-0023 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20131023 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.1; 62.6; 41.7; 23; 16.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0024_6cee9c44-1927-48e6-8cc9-baeae6d6dc5f 13630-0024 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20131106 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.1; 62.7; 41.8; 23; 16.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0025_7b862e51-7fce-45a3-85d4-92b1e22256d7 13630-0025 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20131029 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.2; 84; 42; 23.1; 33.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0026_1efd5beb-ab7c-48d1-a3e6-4095dea58b56 13630-0026 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20131029 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.2; 84; 42; 23.1; 33.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0027_3ec2a7d7-eec6-4b68-986b-b47488ebe394 13630-0027 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20120614 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.8; 86; 43; 23.7; 34.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0028_640ec9fd-2fac-4628-9de5-9ee633464896 13630-0028 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene SPRAY TOPICAL 20131215 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.8; 42; 15.5 mg/mL; mg/mL; mg/mL 13630-0029_4a571818-e554-4d6b-8fe8-86dd526a0e97 13630-0029 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20111230 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 24.9; 62.3; 41.5; 27.5; 16.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0030_1f409752-03ce-44e6-8943-5cd1cc8f9653 13630-0030 HUMAN OTC DRUG Panama Jack SPF 15 Ocinoxate, Octisalate, and Oxybenzone SPRAY TOPICAL 20111230 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 40.8; 24.5; 16.3 mg/mL; mg/mL; mg/mL 13630-0031_6b468065-40b6-4e45-9903-e730e97d8290 13630-0031 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20120104 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 16.7; 62.6; 41.8; 22.9; 16.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0032_b97a4809-4b6c-4745-be62-33d2e9fc7a17 13630-0032 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20120104 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 16.7; 62.6; 41.8; 22.9; 16.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0033_04ce72fa-e390-46f3-a36e-4cc7c06cfcd3 13630-0033 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20120109 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25; 83.4; 41.7; 22.9; 33.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0034_21364fea-0e9d-4f64-bfa7-f9a98a8f3394 13630-0034 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120109 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25; 83.4; 41.7; 22.9; 33.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0035_2a18bbf3-3e26-46d9-bdcd-ed4503988034 13630-0035 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120109 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25; 83.4; 41.7; 22.9; 33.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0036_5f9530b4-df56-451f-90c4-cedb9f1849e8 13630-0036 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120221 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.6; 106.8; 42.7; 23.5; 51.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0037_932c54e9-f5da-410a-b6e4-daf614b83c7f 13630-0037 HUMAN OTC DRUG Aloe Up Broad Spectrum SPF 15 Avobenzone, Octisalate, and Octocrylene SPRAY TOPICAL 20130301 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.1; 40.3; 14.9 mg/mL; mg/mL; mg/mL 13630-0038_2a181405-0a45-492c-a0ee-332ad07d9c62 13630-0038 HUMAN OTC DRUG Aloe Up Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130301 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.6; 63.9; 42.7; 23.6; 17.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0039_3ce61a63-446d-4e74-9309-b83444908da9 13630-0039 HUMAN OTC DRUG Aloe Up Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130301 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.8; 85.8; 42.9; 23.6; 34.3 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0040_cc49aa36-6275-4a23-b776-40bcc6c85cd9 13630-0040 HUMAN OTC DRUG Aloe Up Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130417 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.8; 85.8; 42.9; 23.6; 34.3 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0041_40bd6bdf-69bd-4818-a584-ee983188e7d6 13630-0041 HUMAN OTC DRUG Aloe Up Dark Tanning Oil SPF 4 Octinoxate and Oxybenzone SPRAY TOPICAL 20090105 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. OCTINOXATE; OXYBENZONE 16.6; 16.6 mg/mL; mg/mL 13630-0042_dde71ef8-2dce-483a-a044-30238d9d8623 13630-0042 HUMAN OTC DRUG Ulta SPF30 Homosalate, Octinoxate, Octisalate, and Oxybenzone SPRAY TOPICAL 20070423 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 42; 63; 43; 33.6 mg/mL; mg/mL; mg/mL; mg/mL 13630-0043_517f1020-02d2-432b-92c1-7ce5b67e2506 13630-0043 HUMAN OTC DRUG Ulta SPF 15 Avobenzone, Octisalate, and Octocrylene SPRAY TOPICAL 20081126 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.7; 41.8; 22.9 mg/mL; mg/mL; mg/mL 13630-0044_7d2cbb2c-5a5b-4dd1-b9b6-2dac0865af3d 13630-0044 HUMAN OTC DRUG Ulta Broad Spectrum SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20081126 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.9; 108.1; 43.3; 23.8; 51.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0045_469d41d4-2714-467c-8c95-fbdd1a381313 13630-0045 HUMAN OTC DRUG Sunzen Broad Spectrum SPF 8 Avobenzone, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130321 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 8.2; 24.6; 6.97; 8.2 mg/mL; mg/mL; mg/mL; mg/mL 13630-0046_7142e1f9-f1ff-4a8d-9201-25dffe4678e1 13630-0046 HUMAN OTC DRUG Suntone Broad Spectrum SPF 8 Avobenzone, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130321 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 8.1; 24.3; 6.9; 8.1 mg/mL; mg/mL; mg/mL; mg/mL 13630-0047_52feb811-b37c-4995-b084-392e22e897c0 13630-0047 HUMAN OTC DRUG Suntone Broad Spectrum SPF 4 Avobenzone, Octocrylene and Oxybenzone SPRAY TOPICAL 20130321 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 8.4; 7.1; 4.2 mg/mL; mg/mL; mg/mL 13630-0048_0fa468ab-c6c8-4a63-ac4f-ab0ea2d3abdc 13630-0048 HUMAN OTC DRUG SOLMATE Broad Spectrum SPF 4 Avobenzone, Octocrylene and Oxybenzone SPRAY TOPICAL 20130321 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 8.2; 6.9; 4.1 mg/mL; mg/mL; mg/mL 13630-0049_fb837a81-289d-4d1b-8265-60973e91f0da 13630-0049 HUMAN OTC DRUG SUNZEN Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.6; 63.9; 42.7; 23.5; 17.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0050_ad7fd343-9452-4586-b099-ea503c9884f3 13630-0050 HUMAN OTC DRUG SolMate Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.6; 63.9; 42.7; 23.5; 17.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0051_5cf97828-6ea9-41ec-b5b6-1b0ef7003d61 13630-0051 HUMAN OTC DRUG SOLMATE Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.6; 63.9; 42.7; 23.5; 17.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0052_b9529c8e-1110-4d67-a90c-494dc40df3dd 13630-0052 HUMAN OTC DRUG SOLMATE Broad Spectrum SPF 30 Avobenzone, Homsalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.6; 63.9; 42.7; 23.5; 17.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0053_23e74dc6-598e-40b6-a7d9-7c693410a332 13630-0053 HUMAN OTC DRUG SOLMATE Broad Spectrum SPF 30 Avobenzone, Homsalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130430 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.6; 63.9; 42.7; 23.5; 17.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0054_adeb1ebd-ec64-4867-a3a2-2f22b45f505b 13630-0054 HUMAN OTC DRUG SolMate Broad Spectrum SPF 15 Avobenzone, Octisalate, and Octocrylene SPRAY TOPICAL 20130403 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.3; 40.8; 22.4 mg/mL; mg/mL; mg/mL 13630-0055_39d5ec55-0b43-4fe4-9fd3-895f07bb1992 13630-0055 HUMAN OTC DRUG Sunzen Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130416 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.5; 85; 42.5; 23.4; 34 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0056_74887c03-7ea2-4ad3-b415-ceaf34b66271 13630-0056 HUMAN OTC DRUG SolMate Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.4; 84.7; 42.4; 23.3; 33.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0057_5bd5b714-cae7-4741-aa36-df0703ebc409 13630-0057 HUMAN OTC DRUG SolMate Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20120423 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.4; 84.7; 42.4; 23.3; 33.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0058_1706f684-458b-4fb5-88e3-4ad42fd275c3 13630-0058 HUMAN OTC DRUG SolMate Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20120416 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.4; 84.7; 42.4; 23.3; 33.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0062_2b908d4d-4997-4c8c-8563-5432fb762c13 13630-0062 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene and Octobenzone SPRAY TOPICAL 20131215 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 24.8; 62.1; 41.4; 22.8; 16.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13630-0063_af5f8657-96ff-420a-92d1-7bd3e0aa4e0f 13630-0063 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20131215 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.5; 84.9; 42.5; 23.4; 34 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 13632-123_653917f0-f878-11e1-a21f-0800200c9a66 13632-123 HUMAN PRESCRIPTION DRUG Soltamox tamoxifen citrate LIQUID ORAL 20121001 NDA NDA021807 Rosemont Pharmaceuticals Ltd TAMOXIFEN CITRATE 10 mg/5mL Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 13668-001_dfe4a36d-b06e-41b5-bc12-5639641ddf93 13668-001 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20070124 ANDA ANDA077711 Torrent Pharmaceuticals Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 13668-002_dfe4a36d-b06e-41b5-bc12-5639641ddf93 13668-002 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20070124 ANDA ANDA077711 Torrent Pharmaceuticals Limited METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 13668-003_dfe4a36d-b06e-41b5-bc12-5639641ddf93 13668-003 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20070124 ANDA ANDA077711 Torrent Pharmaceuticals Limited METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 13668-004_89622982-f40f-4553-8506-a8fd3d6cfde7 13668-004 HUMAN PRESCRIPTION DRUG Sertraline hydrochloride Sertraline hydrochloride TABLET, FILM COATED ORAL 20070905 ANDA ANDA077765 Torrent Pharmaceuticals Limited SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-005_89622982-f40f-4553-8506-a8fd3d6cfde7 13668-005 HUMAN PRESCRIPTION DRUG Sertraline hydrochloride Sertraline hydrochloride TABLET, FILM COATED ORAL 20070905 ANDA ANDA077765 Torrent Pharmaceuticals Limited SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-006_89622982-f40f-4553-8506-a8fd3d6cfde7 13668-006 HUMAN PRESCRIPTION DRUG Sertraline hydrochloride Sertraline hydrochloride TABLET, FILM COATED ORAL 20070905 ANDA ANDA077765 Torrent Pharmaceuticals Limited SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-007_aa40719d-817d-4a38-826a-de2791549013 13668-007 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Torrent Pharmaceuticals Limited ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 13668-008_aa40719d-817d-4a38-826a-de2791549013 13668-008 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Torrent Pharmaceuticals Limited ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 13668-009_fdb7e76a-9864-4f69-b0ff-6fef4dc211f0 13668-009 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Torrent Pharmaceuticals Limited CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-010_fdb7e76a-9864-4f69-b0ff-6fef4dc211f0 13668-010 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Torrent Pharmaceuticals Limited CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-011_fdb7e76a-9864-4f69-b0ff-6fef4dc211f0 13668-011 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Torrent Pharmaceuticals Limited CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-012_8ffb7553-a464-4ec1-b00e-5651d66d449f 13668-012 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091230 ANDA ANDA090014 Torrent Pharmaceuticals Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 13668-013_8ffb7553-a464-4ec1-b00e-5651d66d449f 13668-013 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20100218 ANDA ANDA079226 Torrent Pharmaceuticals Limited METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 13668-014_78b48a1b-7cae-4774-a155-e8034a257ca5 13668-014 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078858 Torrent Pharmaceuticals Limited LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 13668-015_78b48a1b-7cae-4774-a155-e8034a257ca5 13668-015 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078858 Torrent Pharmaceuticals Limited LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 13668-016_78b48a1b-7cae-4774-a155-e8034a257ca5 13668-016 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078858 Torrent Pharmaceuticals Limited LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 13668-017_78b48a1b-7cae-4774-a155-e8034a257ca5 13668-017 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078858 Torrent Pharmaceuticals Limited LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 13668-018_46f55c3c-e168-4dda-9ed9-b76c2b5ab297 13668-018 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090899 Torrent Pharmaceuticals Limited VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-019_46f55c3c-e168-4dda-9ed9-b76c2b5ab297 13668-019 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090899 Torrent Pharmaceuticals Limited VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-020_46f55c3c-e168-4dda-9ed9-b76c2b5ab297 13668-020 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090899 Torrent Pharmaceuticals Limited VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-021_47fae4fa-d1f7-4076-90eb-9cdddc6ab8b3 13668-021 HUMAN PRESCRIPTION DRUG ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20110718 ANDA ANDA079054 Torrent Pharmaceuticals Limited ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 13668-022_07571016-4101-46f6-ab51-39391b4c0219 13668-022 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20090205 ANDA ANDA078573 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 13668-023_07571016-4101-46f6-ab51-39391b4c0219 13668-023 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20090205 ANDA ANDA078573 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 13668-024_07571016-4101-46f6-ab51-39391b4c0219 13668-024 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20090205 ANDA ANDA078573 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 13668-029_6ed6ecbe-d11c-463b-81e5-e3da0073106e 13668-029 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20100415 ANDA ANDA079191 Torrent Pharmaceuticals Limited CETIRIZINE HYDROCHLORIDE 5 mg/1 13668-029_e1ce1874-89d5-499f-a042-99224346b87c 13668-029 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20100415 ANDA ANDA079191 Torrent Pharmaceuticals Limited CETIRIZINE HYDROCHLORIDE 5 mg/1 13668-030_881902c5-e6a8-4425-85c0-446b1ff9e0fd 13668-030 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20100415 ANDA ANDA079191 Torrent Pharmaceuticals Limited CETIRIZINE HYDROCHLORIDE 10 mg/1 13668-030_d3a0c14b-0204-40bc-ab0f-a58e0700850d 13668-030 HUMAN OTC DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET ORAL 20100415 ANDA ANDA079191 Torrent Pharmaceuticals Limited CETIRIZINE HYDROCHLORIDE 10 mg/1 13668-031_438c2ddd-5eb4-48e3-acd8-594551cca5e7 13668-031 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 Torrent Pharmaceuticals Limited TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 13668-032_438c2ddd-5eb4-48e3-acd8-594551cca5e7 13668-032 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 Torrent Pharmaceuticals Limited TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 13668-033_438c2ddd-5eb4-48e3-acd8-594551cca5e7 13668-033 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 Torrent Pharmaceuticals Limited TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 13668-034_438c2ddd-5eb4-48e3-acd8-594551cca5e7 13668-034 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 Torrent Pharmaceuticals Limited TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 13668-035_c02f3ff1-eaa6-415d-81da-2639dfbc7901 13668-035 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Torrent Pharmaceuticals Limited RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 13668-036_c02f3ff1-eaa6-415d-81da-2639dfbc7901 13668-036 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Torrent Pharmaceuticals Limited RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 13668-037_c02f3ff1-eaa6-415d-81da-2639dfbc7901 13668-037 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Torrent Pharmaceuticals Limited RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 13668-038_c02f3ff1-eaa6-415d-81da-2639dfbc7901 13668-038 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Torrent Pharmaceuticals Limited RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 13668-039_c02f3ff1-eaa6-415d-81da-2639dfbc7901 13668-039 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Torrent Pharmaceuticals Limited RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 13668-040_c02f3ff1-eaa6-415d-81da-2639dfbc7901 13668-040 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Torrent Pharmaceuticals Limited RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 13668-045_a873dcb4-ab7e-4d91-a862-8b02b2cf29f0 13668-045 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20090127 ANDA ANDA078947 Torrent Pharmaceuticals Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 13668-047_a873dcb4-ab7e-4d91-a862-8b02b2cf29f0 13668-047 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20090127 ANDA ANDA078947 Torrent Pharmaceuticals Limited LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 13668-048_a873dcb4-ab7e-4d91-a862-8b02b2cf29f0 13668-048 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20090127 ANDA ANDA078947 Torrent Pharmaceuticals Limited LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 13668-049_a873dcb4-ab7e-4d91-a862-8b02b2cf29f0 13668-049 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20090127 ANDA ANDA078947 Torrent Pharmaceuticals Limited LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 13668-079_d2bf3d19-6a62-4638-9b67-51908e4bccdd 13668-079 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA090984 Torrent Pharmaceuticals Limited MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 13668-080_d2bf3d19-6a62-4638-9b67-51908e4bccdd 13668-080 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA090984 Torrent Pharmaceuticals Limited MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 13668-081_d2bf3d19-6a62-4638-9b67-51908e4bccdd 13668-081 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET ORAL 20120803 ANDA ANDA201515 Torrent Pharmaceuticals Limited MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 13668-082_19ea3ba2-37ed-4f15-826a-5a6fe185ea6d 13668-082 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET ORAL 20110620 ANDA ANDA090722 Torrent Pharmaceuticals Limited LEVOFLOXACIN 250 mg/1 13668-083_19ea3ba2-37ed-4f15-826a-5a6fe185ea6d 13668-083 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET ORAL 20110620 ANDA ANDA090722 Torrent Pharmaceuticals Limited LEVOFLOXACIN 500 mg/1 13668-084_19ea3ba2-37ed-4f15-826a-5a6fe185ea6d 13668-084 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET ORAL 20110620 ANDA ANDA090722 Torrent Pharmaceuticals Limited LEVOFLOXACIN 750 mg/1 13668-086_2bf03e8f-1608-4f72-92fa-3ae975adca91 13668-086 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20111025 ANDA ANDA091415 Torrent Pharmaceuticals Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 13668-088_2bf03e8f-1608-4f72-92fa-3ae975adca91 13668-088 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20111025 ANDA ANDA091415 Torrent Pharmaceuticals Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 13668-089_2bf03e8f-1608-4f72-92fa-3ae975adca91 13668-089 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20111025 ANDA ANDA091415 Torrent Pharmaceuticals Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 13668-090_2bf03e8f-1608-4f72-92fa-3ae975adca91 13668-090 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20111025 ANDA ANDA091415 Torrent Pharmaceuticals Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 13668-091_6b396fc8-b1ce-4103-9026-4010a3c74088 13668-091 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Torrent Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 13668-092_6b396fc8-b1ce-4103-9026-4010a3c74088 13668-092 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Torrent Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 13668-093_6b396fc8-b1ce-4103-9026-4010a3c74088 13668-093 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Torrent Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 13668-094_6b396fc8-b1ce-4103-9026-4010a3c74088 13668-094 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Torrent Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 13668-095_6b396fc8-b1ce-4103-9026-4010a3c74088 13668-095 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Torrent Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 13668-096_ce11ac50-f5cf-4df6-8f8d-6b266a010938 13668-096 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA090074 Torrent Pharmaceuticals Limited PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 13668-102_6774c709-fd02-4138-8020-113695786a61 13668-102 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 Torrent Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 13668-103_6774c709-fd02-4138-8020-113695786a61 13668-103 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 Torrent Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 13668-104_21162c2a-2cb5-4c49-a78a-d5e3ed9f3b04 13668-104 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200270 Torrent Pharmaceuticals Limited ISOSORBIDE MONONITRATE 30 mg/1 13668-105_21162c2a-2cb5-4c49-a78a-d5e3ed9f3b04 13668-105 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200495 Torrent Pharmaceuticals Limited ISOSORBIDE MONONITRATE 60 mg/1 13668-106_21162c2a-2cb5-4c49-a78a-d5e3ed9f3b04 13668-106 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200495 Torrent Pharmaceuticals Limited ISOSORBIDE MONONITRATE 120 mg/1 13668-107_0aedcb21-bbde-44cd-a2c6-441c54ef341d 13668-107 HUMAN PRESCRIPTION DRUG Rabeprazole sodium Rabeprazole sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA202376 Torrent Pharmaceuticals Limited RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 13668-109_58db491c-0b0f-48da-8543-0669268a5f44 13668-109 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Torrent Pharmaceuticals Limited DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-110_58db491c-0b0f-48da-8543-0669268a5f44 13668-110 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Torrent Pharmaceuticals Limited DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-111_58db491c-0b0f-48da-8543-0669268a5f44 13668-111 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Torrent Pharmaceuticals Limited DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-113_4c4ee613-3c18-48d4-820c-760d5c795311 13668-113 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Torrent Pharmaceuticals Limited LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 13668-115_4c4ee613-3c18-48d4-820c-760d5c795311 13668-115 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Torrent Pharmaceuticals Limited LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 13668-116_ede163d6-ec79-46c1-ba47-046d43d2b887 13668-116 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA090528 Torrent Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 13668-117_ede163d6-ec79-46c1-ba47-046d43d2b887 13668-117 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20100406 ANDA ANDA090528 Torrent Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 13668-118_ede163d6-ec79-46c1-ba47-046d43d2b887 13668-118 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA090528 Torrent Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 13668-119_92eff5ce-dada-4945-86d8-c1dd5aba416f 13668-119 HUMAN PRESCRIPTION DRUG PIOGLITAZONEHYDROCHLORIDE PIOGLITAZONEHYDROCHLORIDE TABLET ORAL 20130213 ANDA ANDA091298 Torrent Pharmaceuticals Limited PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 13668-120_92eff5ce-dada-4945-86d8-c1dd5aba416f 13668-120 HUMAN PRESCRIPTION DRUG PIOGLITAZONEHYDROCHLORIDE PIOGLITAZONEHYDROCHLORIDE TABLET ORAL 20130213 ANDA ANDA091298 Torrent Pharmaceuticals Limited PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 13668-132_97983f2f-7a3c-4400-90ae-fe5fc7e09f0c 13668-132 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20111128 ANDA ANDA202170 Torrent Pharmaceuticals Limited FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 13668-133_97983f2f-7a3c-4400-90ae-fe5fc7e09f0c 13668-133 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20111128 ANDA ANDA202170 Torrent Pharmaceuticals Limited FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 13668-134_97983f2f-7a3c-4400-90ae-fe5fc7e09f0c 13668-134 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20111128 ANDA ANDA202170 Torrent Pharmaceuticals Limited FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 13668-135_b43640d7-fcc4-4fa2-8582-d7b7a5317aad 13668-135 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20120911 ANDA ANDA090939 Torrent Pharmaceuticals Limited ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-136_b43640d7-fcc4-4fa2-8582-d7b7a5317aad 13668-136 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20120911 ANDA ANDA090939 Torrent Pharmaceuticals Limited ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-137_b43640d7-fcc4-4fa2-8582-d7b7a5317aad 13668-137 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20120911 ANDA ANDA090939 Torrent Pharmaceuticals Limited ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-140_92eff5ce-dada-4945-86d8-c1dd5aba416f 13668-140 HUMAN PRESCRIPTION DRUG PIOGLITAZONEHYDROCHLORIDE PIOGLITAZONEHYDROCHLORIDE TABLET ORAL 20130213 ANDA ANDA091298 Torrent Pharmaceuticals Limited PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 13668-141_fcfeae24-83ae-4362-b129-fcda163486bd 13668-141 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET ORAL 20120517 ANDA ANDA090844 Torrent Pharmaceuticals Limited CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 13668-148_2c39d214-b386-4dd2-8c46-eccd1953a647 13668-148 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET ORAL 20120327 ANDA ANDA200363 Torrent Pharmaceuticals Limited QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 13668-149_2c39d214-b386-4dd2-8c46-eccd1953a647 13668-149 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET ORAL 20120327 ANDA ANDA200363 Torrent Pharmaceuticals Limited QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 13668-150_2c39d214-b386-4dd2-8c46-eccd1953a647 13668-150 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET ORAL 20120327 ANDA ANDA200363 Torrent Pharmaceuticals Limited QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 13668-151_2c39d214-b386-4dd2-8c46-eccd1953a647 13668-151 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET ORAL 20120327 ANDA ANDA200363 Torrent Pharmaceuticals Limited QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 13668-152_2c39d214-b386-4dd2-8c46-eccd1953a647 13668-152 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET ORAL 20120327 ANDA ANDA200363 Torrent Pharmaceuticals Limited QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 13668-153_2c39d214-b386-4dd2-8c46-eccd1953a647 13668-153 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET ORAL 20120327 ANDA ANDA200363 Torrent Pharmaceuticals Limited QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 13668-156_fdbf9684-cfcd-403b-b088-311f40dc5cc3 13668-156 HUMAN PRESCRIPTION DRUG TELMISARTAN TELMISARTAN TABLET ORAL 20140707 ANDA ANDA203171 Torrent Pharmaceuticals Limited TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 13668-157_fdbf9684-cfcd-403b-b088-311f40dc5cc3 13668-157 HUMAN PRESCRIPTION DRUG TELMISARTAN TELMISARTAN TABLET ORAL 20140707 ANDA ANDA203171 Torrent Pharmaceuticals Limited TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 13668-158_fdbf9684-cfcd-403b-b088-311f40dc5cc3 13668-158 HUMAN PRESCRIPTION DRUG TELMISARTAN TELMISARTAN TABLET ORAL 20140707 ANDA ANDA203171 Torrent Pharmaceuticals Limited TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 13668-159_65159136-2c71-41e4-86ae-d637859250f2 13668-159 HUMAN PRESCRIPTION DRUG telmisartan and hydrochlorthiazide telmisartan and hydrochlorthiazide TABLET ORAL 20140225 ANDA ANDA201192 Torrent Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 13668-160_65159136-2c71-41e4-86ae-d637859250f2 13668-160 HUMAN PRESCRIPTION DRUG telmisartan and hydrochlorthiazide telmisartan and hydrochlorthiazide TABLET ORAL 20140225 ANDA ANDA201192 Torrent Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 13668-161_65159136-2c71-41e4-86ae-d637859250f2 13668-161 HUMAN PRESCRIPTION DRUG telmisartan and hydrochlorthiazide telmisartan and hydrochlorthiazide TABLET ORAL 20140225 ANDA ANDA201192 Torrent Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; TELMISARTAN 25; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 13668-166_2bf03e8f-1608-4f72-92fa-3ae975adca91 13668-166 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 Torrent Pharmaceuticals Limited OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 13668-167_2bf03e8f-1608-4f72-92fa-3ae975adca91 13668-167 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 Torrent Pharmaceuticals Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 13668-168_2bf03e8f-1608-4f72-92fa-3ae975adca91 13668-168 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 Torrent Pharmaceuticals Limited OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 13668-169_2bf03e8f-1608-4f72-92fa-3ae975adca91 13668-169 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 Torrent Pharmaceuticals Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 13668-170_2bf03e8f-1608-4f72-92fa-3ae975adca91 13668-170 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 Torrent Pharmaceuticals Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 13668-171_2bf03e8f-1608-4f72-92fa-3ae975adca91 13668-171 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 Torrent Pharmaceuticals Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 13668-184_6b396fc8-b1ce-4103-9026-4010a3c74088 13668-184 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Torrent Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 13668-185_86fc07b1-669f-4daf-bf9b-f019d3e97680 13668-185 HUMAN PRESCRIPTION DRUG SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET ORAL 20121106 ANDA ANDA091479 Torrent Pharmaceuticals Limited SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 13668-201_5c2feead-37bf-419c-ad4c-677b2c127148 13668-201 HUMAN PRESCRIPTION DRUG moxifloxacin hydrochloride moxifloxacin hydrochloride TABLET ORAL 20140403 ANDA ANDA200160 Torrent Pharmaceuticals Limited MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 13668-266_a873dcb4-ab7e-4d91-a862-8b02b2cf29f0 13668-266 HUMAN PRESCRIPTION DRUG LAMOTRIGINE lamotrigine KIT 20090914 ANDA ANDA078947 Torrent Pharmaceuticals Limited 13668-268_494d2b55-0f70-4e93-91bc-ddab45cd6cab 13668-268 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20091023 ANDA ANDA077272 Torrent Pharmaceuticals Limited CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 13668-271_494d2b55-0f70-4e93-91bc-ddab45cd6cab 13668-271 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET, CHEWABLE ORAL 20090826 ANDA ANDA075712 Torrent Pharmaceuticals Limited CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 13668-272_1b7589e7-3c59-42f7-86fa-a0f76907b10d 13668-272 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE ORAL 20120529 ANDA ANDA091338 Torrent Pharmaceuticals Limited LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 13668-280_e90687b7-28e4-4f0e-965c-bc408d1eef9a 13668-280 HUMAN PRESCRIPTION DRUG Pioglitazone HCL and Metformin HCL Pioglitazone HCL and Metformin HCL TABLET ORAL 20130213 ANDA ANDA202001 Torrent Pharmaceuticals Limited METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500; 15 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 13668-281_e90687b7-28e4-4f0e-965c-bc408d1eef9a 13668-281 HUMAN PRESCRIPTION DRUG Pioglitazone HCL and Metformin HCL Pioglitazone HCL and Metformin HCL TABLET ORAL 20130213 ANDA ANDA202001 Torrent Pharmaceuticals Limited METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 13668-290_cff3806e-48f1-494c-85ab-b37f405840bc 13668-290 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate CAPSULE, EXTENDED RELEASE ORAL 20141031 ANDA ANDA203240 Torrent Pharmaceuticals Limited FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-291_cff3806e-48f1-494c-85ab-b37f405840bc 13668-291 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate CAPSULE, EXTENDED RELEASE ORAL 20141031 ANDA ANDA203240 Torrent Pharmaceuticals Limited FLUVOXAMINE MALEATE 150 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13668-300_1b7589e7-3c59-42f7-86fa-a0f76907b10d 13668-300 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE ORAL 20120529 ANDA ANDA091338 Torrent Pharmaceuticals Limited LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 13668-330_db7ba288-21e4-4703-873c-2134048aa637 13668-330 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20131127 ANDA ANDA202180 Torrent Pharmaceuticals Limited TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 13668-331_db7ba288-21e4-4703-873c-2134048aa637 13668-331 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20131127 ANDA ANDA202180 Torrent Pharmaceuticals Limited TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 13668-332_db7ba288-21e4-4703-873c-2134048aa637 13668-332 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20131127 ANDA ANDA202180 Torrent Pharmaceuticals Limited TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 13668-333_db7ba288-21e4-4703-873c-2134048aa637 13668-333 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20131127 ANDA ANDA202180 Torrent Pharmaceuticals Limited TRAZODONE HYDROCHLORIDE 300 mg/1 Serotonin Reuptake Inhibitor [EPC] 13668-339_61b26276-9415-4b5a-ae03-34ee44d89295 13668-339 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20131223 ANDA ANDA203370 Torrent Pharmaceuticals Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 13668-340_61b26276-9415-4b5a-ae03-34ee44d89295 13668-340 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20131223 ANDA ANDA203370 Torrent Pharmaceuticals Limited LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 13668-341_61b26276-9415-4b5a-ae03-34ee44d89295 13668-341 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20131223 ANDA ANDA203370 Torrent Pharmaceuticals Limited LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 13668-342_61b26276-9415-4b5a-ae03-34ee44d89295 13668-342 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20131223 ANDA ANDA203370 Torrent Pharmaceuticals Limited LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 13668-343_482ba00b-8d99-4a2e-a9ed-0a752d1f5ff2 13668-343 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA202517 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; TELMISARTAN 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 13668-344_482ba00b-8d99-4a2e-a9ed-0a752d1f5ff2 13668-344 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA202517 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; TELMISARTAN 5; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 13668-345_482ba00b-8d99-4a2e-a9ed-0a752d1f5ff2 13668-345 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA202517 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; TELMISARTAN 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 13668-346_482ba00b-8d99-4a2e-a9ed-0a752d1f5ff2 13668-346 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA202517 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; TELMISARTAN 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 13668-409_4c4ee613-3c18-48d4-820c-760d5c795311 13668-409 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Torrent Pharmaceuticals Limited LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 13668-429_ce11ac50-f5cf-4df6-8f8d-6b266a010938 13668-429 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA090074 Torrent Pharmaceuticals Limited PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 13668-430_f7b31cba-33d0-422b-98d3-8e62ccb1550b 13668-430 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20141031 ANDA ANDA203969 Torrent Pharmaceuticals Limited BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 13668-431_f7b31cba-33d0-422b-98d3-8e62ccb1550b 13668-431 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20141031 ANDA ANDA203969 Torrent Pharmaceuticals Limited BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 13668-432_f7b31cba-33d0-422b-98d3-8e62ccb1550b 13668-432 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20141031 ANDA ANDA203969 Torrent Pharmaceuticals Limited BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 13709-230_4c8ccbcb-a74e-414f-aba2-d89cb28776ca 13709-230 HUMAN OTC DRUG ClearCanal NeilMed Ear Wax Removal Complete Kit SOLUTION/ DROPS AURICULAR (OTIC) 20110824 OTC MONOGRAPH FINAL part344 NeilMed Pharmaceuticals, Inc. CARBAMIDE PEROXIDE 65 mg/mL 13709-231_46549bdf-f029-47a9-987a-3c4cad9659fb 13709-231 HUMAN OTC DRUG SinuFrin NeilMed Oxymetazoline Hydrochloride SPRAY NASAL 20120715 OTC MONOGRAPH FINAL part341 NeilMed Pharmaceuticals Inc OXYMETAZOLINE HYDROCHLORIDE 7.5 mg/15mL CII 13709-232_c243e7d4-0748-468b-8e25-b914adafdf83 13709-232 HUMAN OTC DRUG SinuFrin Plus NeilMed Oxymetazoline Hydrochloride SPRAY NASAL 20120715 OTC MONOGRAPH FINAL part341 NeilMed Pharmaceuticals, Inc. OXYMETAZOLINE HYDROCHLORIDE 7.5 mg/15mL CII 13709-281_206a1894-676f-442a-ad54-f78c5c0d8ab6 13709-281 HUMAN OTC DRUG Sinu Inhaler Levmetamfetamine Nasal Decongestant INHALANT NASAL 20140615 OTC MONOGRAPH FINAL part341 NeilMed LEVMETAMFETAMINE 50 mg/1 13733-001_2fdd6eb6-eac2-421f-bb89-3915ac84f052 13733-001 HUMAN OTC DRUG MISSHA M WATERY B.B SPF 27 TITANIUM DIOXIDE CREAM CUTANEOUS 20080416 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE 3.57 mL/50mL 13733-002_96d871b4-45b8-4e8f-be43-ad3daf881f85 13733-002 HUMAN OTC DRUG MISSHA M PERFECT COVER BB SPF42 ZINC OXIDE CREAM CUTANEOUS 20071024 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. ZINC OXIDE 3.5 mL/50mL 13733-003_0f1f9ab4-b703-4dd9-9e36-a0c7dbfc3b9f 13733-003 HUMAN OTC DRUG MISSHA M SHINY BB SPF27 TITANIUM DIOXIDE CREAM CUTANEOUS 20080416 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE 3.77 mL/50mL 13733-004_3dfb44a5-ba5c-4d90-a48b-05b3bf5bb92a 13733-004 HUMAN OTC DRUG MISSHA M SIGNATURE RADIANCE FOUNDATION SPF20 TITANIUM DIOXIDE CREAM CUTANEOUS 20090219 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE 3.25 mL/35mL 13733-005_d0468086-4f2b-4808-9ae2-3f2cdb72c049 13733-005 HUMAN OTC DRUG MISSHA M SIGNATURE RADIANCE TWO WAY PACT SPF27 TITANIUM DIOXIDE POWDER CUTANEOUS 20090210 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE .98 g/11g 13733-006_649dd1c6-0300-4fcb-829a-430e9551b6bc 13733-006 HUMAN OTC DRUG MISSHA M VITA BB SPF20 TITANIUM DIOXIDE CREAM CUTANEOUS 20070502 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE 3.5 mL/50mL 13733-010_17b5837d-7f6e-45be-a303-88a400155da6 13733-010 HUMAN OTC DRUG MISSHA M SIGNATURE REAL COMPLETE BB SPF25 PA PLUS PLUS TITANIUM DIOXIDE CREAM CUTANEOUS 20110601 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 3.24; 1.71 g/45g; g/45g 13733-011_61f0aebb-6289-490a-9819-45a1b436e819 13733-011 HUMAN OTC DRUG MISA CHO BO YANG BB SPF30 PA PLUS PLUS NO.1 NATURAL BEIGE TITANIUM DIOXIDE CREAM CUTANEOUS 20110601 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 5.2; .7 mL/50mL; mL/50mL 13733-012_1178386a-35f8-4607-99d9-1dd14ae361c7 13733-012 HUMAN OTC DRUG MISSHA M SWIRL BB SUN BALM SPF50 PLUS PA PLUS PLUS PLUS NO.21 TITANIUM DIOXIDE CREAM CUTANEOUS 20110601 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 4.46; 1.44 g/20g; g/20g 13733-013_ec72eb63-1942-41c8-b8ea-f95b474d51c1 13733-013 HUMAN OTC DRUG MISSHA SIGNATURE WRINKLE FILLER BB SPF37 PA PLUS PLUS NO.23 TITANIUM DIOXIDE CREAM CUTANEOUS 20110601 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.2; 4.268; 1.276 g/44g; g/44g; g/44g 13733-014_8b72633e-c1cd-4722-8c81-f82807e9605c 13733-014 HUMAN OTC DRUG MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN SPF45 PA PLUS PLUS PLUS OCTINOXATE CREAM CUTANEOUS 20110601 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. ENSULIZOLE; OCTINOXATE; OCTISALATE 2; 3.5; 2.4 mL/50mL; mL/50mL; mL/50mL 13733-015_7074f5d0-8e94-4d19-9f9c-edac53dfa435 13733-015 HUMAN OTC DRUG MISSHA SIGNATURE DRAMATIC WHITENING PACT NO.2 SPF50 PLUS PA PLUS PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120301 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .66; 1.84; .32 g/11g; g/11g; g/11g 13733-016_f2544331-3b7b-4777-9680-c6a8218dc300 13733-016 HUMAN OTC DRUG MISSHA GLAM SILKY BODY BALM SPF 27 Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.88; .48 g/25g; g/25g; g/25g 13733-017_7d4f3728-9ac2-4b6c-9d24-5f22bb430dc9 13733-017 HUMAN OTC DRUG MISSHA M PRISM BRIGHT ON AUTO NO.2 SPF35 PA PLUS PLUS PLUS Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20120301 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .57; .81; .28 g/9.5g; g/9.5g; g/9.5g 13733-018_91c50152-9f70-4b21-9ea2-ea30e3ed365e 13733-018 HUMAN OTC DRUG MISSHA SIGNATURE EXTREME COVER CONCEALER NO.23 SPF30 PA PLUS PLUS Titanium Dioxide CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE 2.28 g/10g 13733-019_9246f162-13b9-430b-b416-dbf8fa8b87af 13733-019 HUMAN OTC DRUG MISSHA TIME REVOLUTION WHITE CURE UV SUN PROTECTOR SPF50 PLUS PA PLUS PLUS PLUS ZINC OXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE 2.66; .76; 3.89 g/38g; g/38g; g/38g 13733-020_78e09168-48fd-4705-a55c-82d0dea65820 13733-020 HUMAN OTC DRUG MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN BROAD SPECTRUM SPF45 OCTINOXATE, OCTISALATE, ENSULIZOLE CREAM TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 ABLE C&C CO., LTD. ENSULIZOLE; OCTINOXATE; OCTISALATE 2; 3.5; 2.4 mg/50mL; mg/50mL; mg/50mL 13733-030_d1d93232-f790-494f-bd75-aaa7f3ceb1c9 13733-030 HUMAN OTC DRUG MISSHA ALL AROUND SAFE BLOCK SOFT FINISH SUN MILK BROAD SPECTRUM SPF 50 PLUS OCTINOXATE, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 ABLE C&C CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3; .87; 2.76 mg/40mL; mg/40mL; mg/40mL 13733-040_7cfc2977-2e19-4c38-b3fc-69b2c7013fcc 13733-040 HUMAN OTC DRUG MISSHA SIGNATURE COMPLEXION COORDINATING BB BEIGE BROAD SPECTRUM SPF43 Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 ABLE C&C CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.5; 4.96; 3.5 mg/50mL; mg/50mL; mg/50mL 13733-050_0424c9ce-6432-4ddf-bd28-46b4b473f5e3 13733-050 HUMAN OTC DRUG MISSHA SIGNATURE COMPLEXION COORDINATING BB WHITE BROAD SPECTRUM SPF43 Titanium Dioxide, OCTINOXATE, OCTISALATE, Zinc Oxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 ABLE C&C CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 3.75; 2.5; 4.05; 2.45 mg/50mL; mg/50mL; mg/50mL; mg/50mL 13733-060_44fe86ca-48a4-43cd-b96d-6504fcf9e527 13733-060 HUMAN OTC DRUG MISSHA TIME REVOLUTION WHITE CURE BLANC SUN PROTECTOR NW BROAD SPECTRUM SPF50 PLUS ZINC OXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 ABLE C&C CO., LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE 3.5; 1; 3.75 g/50g; g/50g; g/50g 13733-070_0d5bce0e-8022-4622-a5ad-58cd43f42fcc 13733-070 HUMAN OTC DRUG MISSHA SIGNATURE COMPLEXION COORDINATING BB HONEY BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 ABLE C&C CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.4; 1.55; 1.4 mg/20mL; mg/20mL; mg/20mL 13733-080_f799c721-ed8a-4188-8102-a4c73973a353 13733-080 HUMAN OTC DRUG MISSHA M SIGNATURE REAL COMPLETE BB Honey Beige Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 ABLE C&C Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.47; 1.73 g/45g; g/45g 13734-013_55ca0306-e9c9-4091-96d4-ff5147736082 13734-013 HUMAN OTC DRUG NARS SIBERIA Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-014_55ca0306-e9c9-4091-96d4-ff5147736082 13734-014 HUMAN OTC DRUG NARS PUNJAB Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-015_55ca0306-e9c9-4091-96d4-ff5147736082 13734-015 HUMAN OTC DRUG NARS STROMBOLI Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-016_55ca0306-e9c9-4091-96d4-ff5147736082 13734-016 HUMAN OTC DRUG NARS SYRACUSE Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-017_55ca0306-e9c9-4091-96d4-ff5147736082 13734-017 HUMAN OTC DRUG NARS TAHOE Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-018_55ca0306-e9c9-4091-96d4-ff5147736082 13734-018 HUMAN OTC DRUG NARS CADIZ Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-019_55ca0306-e9c9-4091-96d4-ff5147736082 13734-019 HUMAN OTC DRUG NARS NEW ORLEANS Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-020_55ca0306-e9c9-4091-96d4-ff5147736082 13734-020 HUMAN OTC DRUG NARS BENARES Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-021_55ca0306-e9c9-4091-96d4-ff5147736082 13734-021 HUMAN OTC DRUG NARS DEAUVILLE Octinoxate and Titanium dioxide POWDER TOPICAL 20100401 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 137.2; 184.8 mg/2.8g; mg/2.8g 13734-022_cc162aac-e25d-41b3-88f8-707a037ed471 13734-022 HUMAN OTC DRUG PURE SHEER Aurore Octinoxate and Titanium dioxide LIPSTICK TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE .1258; .0544 g/1.7g; g/1.7g 13734-023_cc162aac-e25d-41b3-88f8-707a037ed471 13734-023 HUMAN OTC DRUG PURE SHEER Greta Octinoxate and Titanium dioxide LIPSTICK TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE .1258; .0544 g/1.7g; g/1.7g 13734-024_cc162aac-e25d-41b3-88f8-707a037ed471 13734-024 HUMAN OTC DRUG PURE SHEER Paloma Octinoxate and Titanium dioxide LIPSTICK TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE .1258; .0544 g/1.7g; g/1.7g 13734-025_cc162aac-e25d-41b3-88f8-707a037ed471 13734-025 HUMAN OTC DRUG PURE SHEER Lara Octinoxate and Titanium dioxide LIPSTICK TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE .1258; .0544 g/1.7g; g/1.7g 13734-026_cc162aac-e25d-41b3-88f8-707a037ed471 13734-026 HUMAN OTC DRUG PURE SHEER Angelique Octinoxate and Titanium dioxide LIPSTICK TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE .1258; .0544 g/1.7g; g/1.7g 13734-027_cc162aac-e25d-41b3-88f8-707a037ed471 13734-027 HUMAN OTC DRUG PURE SHEER Bianca Octinoxate and Titanium dioxide LIPSTICK TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE .1258; .0544 g/1.7g; g/1.7g 13734-029_7e3f1103-15f1-47f1-917a-8292a25d0db5 13734-029 HUMAN OTC DRUG NARS PRO-PRIME MULTI-PROTECT PRIMER Ensulizole, Octinoxate, Octocrylene, and Oxybenzone EMULSION TOPICAL 20110201 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE .9216; 2.24256; .9216; .9216 g/30.72g; g/30.72g; g/30.72g; g/30.72g 13734-030_d0104dfe-2c92-42d6-a831-7c654423da78 13734-030 HUMAN OTC DRUG NARS Pure Radiant Tinted Moisturizer Finland Octinoxate and Titanium Dioxide CREAM TOPICAL 20120301 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 7.4; 6.1 g/100g; g/100g 13734-031_d0104dfe-2c92-42d6-a831-7c654423da78 13734-031 HUMAN OTC DRUG NARS Pure Radiant Tinted Moisturizer Alaska Octinoxate and Titanium Dioxide CREAM TOPICAL 20120301 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 7.4; 6.1 g/100g; g/100g 13734-032_d0104dfe-2c92-42d6-a831-7c654423da78 13734-032 HUMAN OTC DRUG NARS Pure Radiant Tinted Moisturizer Annapurna Octinoxate and Titanium Dioxide CREAM TOPICAL 20120301 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 7.4; 6.1 g/100g; g/100g 13734-033_d0104dfe-2c92-42d6-a831-7c654423da78 13734-033 HUMAN OTC DRUG NARS Pure Radiant Tinted Moisturizer St. Moritz Octinoxate and Titanium Dioxide CREAM TOPICAL 20120301 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 7.4; 6.1 g/100g; g/100g 13734-034_d0104dfe-2c92-42d6-a831-7c654423da78 13734-034 HUMAN OTC DRUG NARS Pure Radiant Tinted Moisturizer Cuba Octinoxate and Titanium Dioxide CREAM TOPICAL 20120301 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 7.4; 6.1 g/100g; g/100g 13734-035_d0104dfe-2c92-42d6-a831-7c654423da78 13734-035 HUMAN OTC DRUG NARS Pure Radiant Tinted Moisturizer Malaga Octinoxate and Titanium Dioxide CREAM TOPICAL 20120301 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 7.4; 6.1 g/100g; g/100g 13734-036_d0104dfe-2c92-42d6-a831-7c654423da78 13734-036 HUMAN OTC DRUG NARS Pure Radiant Tinted Moisturizer Seychelles Octinoxate and Titanium Dioxide CREAM TOPICAL 20120301 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 7.4; 6.1 g/100g; g/100g 13734-037_d0104dfe-2c92-42d6-a831-7c654423da78 13734-037 HUMAN OTC DRUG NARS Pure Radiant Tinted Moisturizer Martinique Octinoxate and Titanium Dioxide CREAM TOPICAL 20120301 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 7.4; 6.1 g/100g; g/100g 13734-038_d0104dfe-2c92-42d6-a831-7c654423da78 13734-038 HUMAN OTC DRUG NARS Pure Radiant Tinted Moisturizer Polynesia Octinoxate and Titanium Dioxide CREAM TOPICAL 20120301 20151201 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 7.4; 6.1 g/100g; g/100g 13734-101_6e8d4e9b-83ee-46b8-8f52-913f8068ace7 13734-101 HUMAN OTC DRUG NARS PRO-PRIME MULTI-PROTECT PRIMER AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 922; 3072; 922; 768; 1229 mg/30.72g; mg/30.72g; mg/30.72g; mg/30.72g; mg/30.72g 13734-102_ab62a0b0-9563-4239-8f07-39e4f272599f 13734-102 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Finland OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g 13734-103_ab62a0b0-9563-4239-8f07-39e4f272599f 13734-103 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Alaska OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g 13734-104_ab62a0b0-9563-4239-8f07-39e4f272599f 13734-104 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Annapurna OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g 13734-105_ab62a0b0-9563-4239-8f07-39e4f272599f 13734-105 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER St. Moritz OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g 13734-106_ab62a0b0-9563-4239-8f07-39e4f272599f 13734-106 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Cuba OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g 13734-107_ab62a0b0-9563-4239-8f07-39e4f272599f 13734-107 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Malaga OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g 13734-108_ab62a0b0-9563-4239-8f07-39e4f272599f 13734-108 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Seychelles OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g 13734-109_ab62a0b0-9563-4239-8f07-39e4f272599f 13734-109 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Martinique OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g 13734-110_ab62a0b0-9563-4239-8f07-39e4f272599f 13734-110 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Polynesia OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g 13734-111_ab62a0b0-9563-4239-8f07-39e4f272599f 13734-111 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Terre-Neuve OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g 13734-112_ab62a0b0-9563-4239-8f07-39e4f272599f 13734-112 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Groenland OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g 13734-113_04c31e9e-3592-46f2-82df-fa70f7ca6c68 13734-113 HUMAN OTC DRUG NARS PRO-PRIME LIGHT OPTIMIZING PRIMER OCTINOXATE, AVOBENZONE, and OCTOCRYLENE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics AVOBENZONE; OCTINOXATE; OCTOCRYLENE 27; 63; 21 mg/1.072g; mg/1.072g; mg/1.072g 13734-114_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-114 HUMAN OTC DRUG NARS FOUNDATION Barcelona OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-115_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-115 HUMAN OTC DRUG NARS FOUNDATION Benares OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-116_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-116 HUMAN OTC DRUG NARS FOUNDATION Cadiz OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-117_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-117 HUMAN OTC DRUG NARS FOUNDATION Deauville OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-118_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-118 HUMAN OTC DRUG NARS FOUNDATION Fiji OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-119_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-119 HUMAN OTC DRUG NARS FOUNDATION Mont Blanc OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-120_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-120 HUMAN OTC DRUG NARS FOUNDATION New Orleans OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-121_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-121 HUMAN OTC DRUG NARS FOUNDATION Punjab OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-122_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-122 HUMAN OTC DRUG NARS FOUNDATION Santa Fe OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-123_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-123 HUMAN OTC DRUG NARS FOUNDATION Siberia OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-124_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-124 HUMAN OTC DRUG NARS FOUNDATION Stromboli OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-125_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-125 HUMAN OTC DRUG NARS FOUNDATION Syracuse OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-126_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-126 HUMAN OTC DRUG NARS FOUNDATION Tahoe OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g 13734-127_94c6895d-8079-4e9b-b7a2-f48f9c9579d7 13734-127 HUMAN OTC DRUG NARS PURE SHEER SPF LIP TREATMENT Angelique OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 126; 54 mg/1.7g; mg/1.7g 13734-128_0a57497f-0f71-4fa9-8377-d05484978930 13734-128 HUMAN OTC DRUG NARS PURE SHEER SPF LIP TREATMENT Bianca OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 126; 54 mg/1.7g; mg/1.7g 13734-129_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-129 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Siberia Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g 13734-130_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-130 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Mont Blanc Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g 13734-131_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-131 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Deauville Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g 13734-132_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-132 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Sweden Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g 13734-133_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-133 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Fiji Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g 13734-134_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-134 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Punjab Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g 13734-135_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-135 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Santa Fe Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g 13734-136_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-136 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Barcelona Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g 13734-137_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-137 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Laponie Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g 13734-138_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-138 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Vallauris Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g 13734-139_d782efbf-4665-4d7e-872c-c231fcd5d079 13734-139 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Stromboli Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 690; 830 mg/10g; mg/10g 13734-140_d782efbf-4665-4d7e-872c-c231fcd5d079 13734-140 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Tahoe Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 690; 830 mg/10g; mg/10g 13734-141_d782efbf-4665-4d7e-872c-c231fcd5d079 13734-141 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Syracuse Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 690; 830 mg/10g; mg/10g 13734-142_d782efbf-4665-4d7e-872c-c231fcd5d079 13734-142 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Cadiz Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 690; 830 mg/10g; mg/10g 13734-143_d782efbf-4665-4d7e-872c-c231fcd5d079 13734-143 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Macao Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 690; 830 mg/10g; mg/10g 13811-050_f5454d63-8c24-479f-9cd4-9608ec2c5e59 13811-050 HUMAN PRESCRIPTION DRUG UltimateCare ONE NF Omega-3 Fatty Acids, Doconexent, Icosapent, Linolenic Acid, Calcium Ascorbate, Calcium Threonate, Cholecalciferol, .Alpha.-Tocopherol Acetate, DL-, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, F CAPSULE ORAL 20091204 UNAPPROVED DRUG OTHER TRIGEN Laboratories, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; BIOTIN; CALCIUM; CALCIUM ASCORBATE; CALCIUM THREONATE; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FERROUS ASPARTO GLYCINATE; FOLIC ACID; ICOSAPENT; IODINE; IRON; LINOLENIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; ZINC OXIDE 15; 300; 100; 24; 1; 800; 350; 50; 7; 1; 100; 150; 20; 50; 50; 10; 500; 50; 1.5; 5 [iU]/1; ug/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] 13811-529_c9c5eb3b-98c0-49ce-89af-7746590e78c9 13811-529 HUMAN PRESCRIPTION DRUG TriAdvance Beta Carotene, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, DL-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, TABLET ORAL 20100910 UNAPPROVED DRUG OTHER TRIGEN Laboratories, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BETA CAROTENE; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; DOCUSATE SODIUM; FOLIC ACID; IRON; MAGNESIUM OXIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 30; 120; 2700; 200; 400; 2; 12; 50; 1; 90; 30; 20; 20; 3.4; 3; 25 [iU]/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 13811-544_18dad510-8579-43c7-9039-efb6e1d19dce 13811-544 HUMAN PRESCRIPTION DRUG Folivane-PRx DHA Ascorbic Acid, Tribasic Calcium Phosphate, Iron, Cholecalciferol, Alpha-Tocopherol, Pyridoxine Hydrochloride, Folic Acid, Doconexent, and Docusate Sodium CAPSULE ORAL 20100101 UNAPPROVED DRUG OTHER TRIGEN Laboratories, Inc. ALPHA-TOCOPHEROL; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON; PYRIDOXINE HYDROCHLORIDE; TRIBASIC CALCIUM PHOSPHATE 30; 25; 170; 265; 55; 1.24; 30; 25; 160 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 13811-558_d8c5dcfc-d6d8-42fc-810a-9dbefd3a8d9d 13811-558 HUMAN PRESCRIPTION DRUG Triveen-PRx RNF Folic Acid, Ascorbic Acid, Tribasic Calcium Phosphate, Iron, Cholecalciferol, Alpha-Tocopherol, Pyridoxine Hydrochloride, Doconexent, and Docusate Sodium CAPSULE ORAL 20100515 UNAPPROVED DRUG OTHER TRIGEN Laboratories, Inc. ALPHA-TOCOPHEROL; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON; PYRIDOXINE HYDROCHLORIDE; TRIBASIC CALCIUM PHOSPHATE 30; 28; 400; 300; 55; 1.2; 26; 25; 160 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 13811-583_5a93cea1-678d-4c0b-950f-7734d74d5655 13811-583 HUMAN PRESCRIPTION DRUG Zatean-CH Calcium Citrate, Iron, Cholecalciferol, .Alpha.-Tocopherol Acetate, DL-, Pyridoxine Hydrochloride, Folic Acid, Docusate Sodium, and Doconexent CAPSULE ORAL 20101101 UNAPPROVED DRUG OTHER TRIGEN Laboratories, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; CALCIUM CITRATE; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON; PYRIDOXINE HYDROCHLORIDE 30; 100; 400; 250; 50; 1; 27; 25 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 13811-598_5f3ba56d-efd2-4361-b40c-045019f0a2cd 13811-598 HUMAN PRESCRIPTION DRUG VemaVite-PRx 2 with Fish-Based DHA Ascorbic Acid, Tribasic Calcium Phosphate, Ferrous Fumarate, Cholecalciferol, Alpha-Tocopherol, Pyridoxine Hydrochloride, Folic Acid, Doconexent, and Docusate Sodium CAPSULE ORAL 20111005 UNAPPROVED DRUG OTHER TRIGEN Laboratories, Inc. ALPHA-TOCOPHEROL; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; TRIBASIC CALCIUM PHOSPHATE 30; 28; 400; 300; 55; 27; 1.25; 25; 160 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 13811-606_cc555edb-3499-48b7-a968-c0d54d5be9b0 13811-606 HUMAN PRESCRIPTION DRUG TL-HEM 150 Ascorbic Acid, .Alpha.-Tocopherol Acetate, DL-, Folic Acid, Cyanocobalamin, Biotin, Iron, Cupric Sulfate, and Docusate Sodium TABLET, FILM COATED ORAL 20110101 UNAPPROVED DRUG OTHER TRIGEN Laboratories, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CUPRIC SULFATE; CYANOCOBALAMIN; DOCUSATE SODIUM; FOLIC ACID; IRON 30; 500; 150; 3; 60; 50; 1; 150 [iU]/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 13811-614_6203b911-e476-485e-8286-dcb9d6907f84 13811-614 HUMAN PRESCRIPTION DRUG Trinatal GT Iron, Biotin, Pantothenic Acid, Calcium Carbonate, Cupric Oxide, Zinc Oxide, Folic Acid, Beta Carotene, Cholecalciferol, .Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Thiamine Mononitrate, Riboflavi TABLET ORAL 20110705 UNAPPROVED DRUG OTHER TRIGEN Laboratories, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BETA CAROTENE; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; DOCUSATE SODIUM; FOLIC ACID; IRON; MAGNESIUM OXIDE; NIACINAMIDE; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 10; 120; 2700; 30; 200; 400; 2; 12; 50; 1; 90; 30; 20; 6; 20; 3.4; 3; 15 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 13811-621_aee7e0ad-d868-4652-be59-ba508d0beacb 13811-621 HUMAN PRESCRIPTION DRUG LEVETIRACETAM Levetiracetam TABLET, FILM COATED ORAL 20120331 ANDA ANDA090906 Trigen Laboratories, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 13811-627_df70c619-a81f-48c3-8ec7-0135dc1fb450 13811-627 HUMAN PRESCRIPTION DRUG benazepril hydrochloride Benazepril hydrochloride TABLET, FILM COATED ORAL 20121115 ANDA ANDA076118 Trigen Laboratories, Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 13811-628_df70c619-a81f-48c3-8ec7-0135dc1fb450 13811-628 HUMAN PRESCRIPTION DRUG BENAZEPRIL HYDROCHLORIDE Benazepril hydrochloride TABLET, FILM COATED ORAL 20121115 ANDA ANDA076118 Trigen Laboratories, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 13811-629_df70c619-a81f-48c3-8ec7-0135dc1fb450 13811-629 HUMAN PRESCRIPTION DRUG BENAZEPRIL HYDROCHLORIDE Benazepril hydrochloride TABLET, FILM COATED ORAL 20121115 ANDA ANDA076118 Trigen Laboratories, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 13811-630_df70c619-a81f-48c3-8ec7-0135dc1fb450 13811-630 HUMAN PRESCRIPTION DRUG BENAZEPRIL HYDROCHLORIDE Benazepril hydrochloride TABLET, FILM COATED ORAL 20121115 ANDA ANDA076118 Trigen Laboratories, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 13811-639_51dfd5e4-0e74-4a5e-acca-bf8094df306e 13811-639 HUMAN PRESCRIPTION DRUG Ropinirole 2 mg Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130615 ANDA ANDA202786 Trigen Laboratories, Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 13811-640_51dfd5e4-0e74-4a5e-acca-bf8094df306e 13811-640 HUMAN PRESCRIPTION DRUG Ropinirole 4 mg Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130615 ANDA ANDA202786 Trigen Laboratories, Inc. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 13811-641_51dfd5e4-0e74-4a5e-acca-bf8094df306e 13811-641 HUMAN PRESCRIPTION DRUG Ropinirole 6 mg Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130615 ANDA ANDA202786 Trigen Laboratories, Inc. ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 13811-642_51dfd5e4-0e74-4a5e-acca-bf8094df306e 13811-642 HUMAN PRESCRIPTION DRUG Ropinirole 8 mg Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130615 ANDA ANDA202786 Trigen Laboratories, Inc. ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 13811-643_51dfd5e4-0e74-4a5e-acca-bf8094df306e 13811-643 HUMAN PRESCRIPTION DRUG Ropinirole 12 mg Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130615 ANDA ANDA202786 Trigen Laboratories, Inc. ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 13811-646_a87565d9-fc68-4414-8063-4152d3e3e002 13811-646 HUMAN OTC DRUG Meclizine HCl MECLIZINE HYDROCHLORIDE TABLETS TABLET ORAL 20130923 OTC MONOGRAPH FINAL part336 Trigen Laboratories, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 13811-647_cdc36345-d71d-43f7-bc03-0738c6f1ebaa 13811-647 HUMAN OTC DRUG Meclizine HCl MECLIZINE HYDROCHLORIDE TABLETS TABLET ORAL 20130923 OTC MONOGRAPH FINAL part336 Trigen Laboratories, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 13811-648_79a4bd44-386d-4756-b772-d60c0c3be05c 13811-648 HUMAN OTC DRUG Meclizine HCl MECLIZINE HYDROCHLORIDE CHEWABLE TABLETS TABLET, CHEWABLE ORAL 20130923 OTC MONOGRAPH FINAL part336 Trigen Laboratories, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 13811-657_d1bd4eaa-4a87-4973-b244-14470aa68e16 13811-657 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20140210 ANDA ANDA040846 Trigen Laboratories, LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 13811-662_0bad4c89-7f73-448a-ae37-6c8c07ce8562 13811-662 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140819 ANDA ANDA202949 Trigen Laboratories, LLC DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13811-663_0bad4c89-7f73-448a-ae37-6c8c07ce8562 13811-663 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140819 ANDA ANDA202949 Trigen Laboratories, LLC DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13811-664_0bad4c89-7f73-448a-ae37-6c8c07ce8562 13811-664 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140819 ANDA ANDA202949 Trigen Laboratories, LLC DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13811-669_364366b9-79ab-441d-8c90-d8713b5cf377 13811-669 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20130917 ANDA ANDA202870 Trigen Laboratories, LLC HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25; 50 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 13811-670_364366b9-79ab-441d-8c90-d8713b5cf377 13811-670 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20130917 ANDA ANDA202870 Trigen Laboratories, LLC HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25; 100 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 13811-671_364366b9-79ab-441d-8c90-d8713b5cf377 13811-671 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20130917 ANDA ANDA202870 Trigen Laboratories, LLC HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 50; 100 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 13811-672_1d1e2328-bf95-41ae-bab5-2d9b7e71cc83 13811-672 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20101221 ANDA ANDA078932 Trigen Laboratories, LLC VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13811-673_1d1e2328-bf95-41ae-bab5-2d9b7e71cc83 13811-673 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20101221 ANDA ANDA078932 Trigen Laboratories, LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13811-674_1d1e2328-bf95-41ae-bab5-2d9b7e71cc83 13811-674 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20101221 ANDA ANDA078932 Trigen Laboratories, LLC VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13811-675_1d1e2328-bf95-41ae-bab5-2d9b7e71cc83 13811-675 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20101221 ANDA ANDA078932 Trigen Laboratories, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13811-676_1d1e2328-bf95-41ae-bab5-2d9b7e71cc83 13811-676 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20101221 ANDA ANDA078932 Trigen Laboratories, LLC VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 13811-677_332aeb48-8a1a-4d50-be12-05411b7a2967 13811-677 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20110506 ANDA ANDA091369 Trigen Laboratories, LLC LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] 13811-678_332aeb48-8a1a-4d50-be12-05411b7a2967 13811-678 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20110506 ANDA ANDA091369 Trigen Laboratories, LLC LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] 13826-001_f049ef8a-08a3-4df2-b330-5092ebd320b8 13826-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850101 NDA NDA205865 Four Corners Welding OXYGEN 990 mL/L 13845-1200_e9dc169f-0f00-411c-9c3e-4ea7b9e85392 13845-1200 HUMAN PRESCRIPTION DRUG SEROMYCIN CYCLOSERINE CAPSULE ORAL 20090301 ANDA ANDA060593 Purdue GMP Center LLC dba The Chao Center CYCLOSERINE 250 mg/250mg 13845-1201_af0b4266-147c-4942-aaf9-4d5b8905207c 13845-1201 HUMAN PRESCRIPTION DRUG CYCLOSERINE CYCLOSERINE CAPSULE ORAL 20090301 ANDA ANDA060593 Purdue GMP Center LLC dba The Chao Center CYCLOSERINE 250 mg/250mg 13845-1202_b5304a23-d1d2-4c24-a56d-2b424d60bb52 13845-1202 HUMAN PRESCRIPTION DRUG Cycloserine Cycloserine CAPSULE ORAL 19520129 ANDA ANDA060593 Purdue GMP Center LLC CYCLOSERINE 250 1/1 13893-689_929a532d-e2eb-48ba-983d-46c8c5992bf1 13893-689 HUMAN OTC DRUG Pin X pyrantel pamoate TABLET, CHEWABLE ORAL 20111031 OTC MONOGRAPH FINAL part357B Quartz Specialty Pharmaceuticals, LLC PYRANTEL PAMOATE 720.5 mg/1 13893-691_5316d89d-9637-4549-8d59-1362b3575018 13893-691 HUMAN OTC DRUG Pin-X pyrantel pamoate LIQUID ORAL 20010901 OTC MONOGRAPH FINAL part357B Quartz Specialty Pharmaceuticals, LLC PYRANTEL PAMOATE 144 mg/mL 13913-001_916845b4-dd49-4c20-a5e9-9a792a788963 13913-001 HUMAN PRESCRIPTION DRUG Proquin XR ciprofloxacin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051001 NDA NDA021744 Depomed, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 13913-002_121fc3e0-33fe-41af-a7ef-e6b54ee60ef6 13913-002 HUMAN PRESCRIPTION DRUG Glumetza metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060801 NDA NDA021748 Depomed, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 13913-003_121fc3e0-33fe-41af-a7ef-e6b54ee60ef6 13913-003 HUMAN PRESCRIPTION DRUG Glumetza metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080617 NDA NDA021748 Depomed, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 13913-004_f2163179-e71f-11e3-ac10-0800200c9a66 13913-004 HUMAN PRESCRIPTION DRUG Gralise gabapentin TABLET, FILM COATED ORAL 20110128 NDA NDA022544 Depomed, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 13913-005_f2163179-e71f-11e3-ac10-0800200c9a66 13913-005 HUMAN PRESCRIPTION DRUG Gralise gabapentin TABLET, FILM COATED ORAL 20110128 NDA NDA022544 Depomed, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 13913-006_f2163179-e71f-11e3-ac10-0800200c9a66 13913-006 HUMAN PRESCRIPTION DRUG Gralise Starter Pack gabapentin KIT 20110128 NDA NDA022544 Depomed, Inc. 13913-008_88e32413-ef7b-11e3-ac10-0800200c9a66 13913-008 HUMAN PRESCRIPTION DRUG Zipsor diclofenac potassium CAPSULE, LIQUID FILLED ORAL 20090616 NDA NDA022202 Depomed, Inc. DICLOFENAC POTASSIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 13913-009_f2160a7a-e71f-11e3-ac10-0800200c9a66 13913-009 HUMAN PRESCRIPTION DRUG Lazanda fentanyl citrate SPRAY NASAL 20111017 NDA NDA022569 Depomed, Inc. FENTANYL CITRATE 100 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 13913-010_f2160a7a-e71f-11e3-ac10-0800200c9a66 13913-010 HUMAN PRESCRIPTION DRUG Lazanda fentanyl citrate SPRAY NASAL 20111017 NDA NDA022569 Depomed, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 13913-011_0a369ac4-c2c2-4746-a578-61c992aba209 13913-011 HUMAN PRESCRIPTION DRUG Cambia diclofenac potassium POWDER, FOR SOLUTION ORAL 20100420 NDA NDA022165 Depomed, Inc. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 13925-040_7820693b-8d38-4ff1-b812-104ee5c5f021 13925-040 HUMAN PRESCRIPTION DRUG Salicylic Acid SALICYLIC ACID KIT 20081101 UNAPPROVED DRUG OTHER Seton Pharmaceuticals 13925-050_ccf94c5e-f9aa-481b-85a7-58f1d3d6033c 13925-050 HUMAN PRESCRIPTION DRUG SALICYLIC ACID SALICYLIC ACID KIT 20081101 UNAPPROVED DRUG OTHER Seton Pharmaceuticals 13925-103_d43d1064-e0b7-421d-9a41-fbc85a393bf9 13925-103 HUMAN PRESCRIPTION DRUG Se-Natal One Vitamin A Acetate, Cholecalciferol, .Alpha.-Tocopherol, Dl, Niacinamide Ascorbate, Folic Acid, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Cyanocobalamin, Biotin, Pantothenic Acid, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Cupric Oxide and Zinc Oxide TABLET ORAL 20090416 UNAPPROVED DRUG OTHER Seton Pharmaceuticals .ALPHA.-TOCOPHEROL ACETATE, DL-; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; NIACINAMIDE ASCORBATE; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A ACETATE; ZINC OXIDE 15; 30; 200; 400; 3; 2.5; 60; 1; 100; 17; 80; 7; 4; 1.6; 1.5; 4000; 25 [iU]/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 13925-104_e91db20c-9f8e-479a-9a12-c4ece7e1e6db 13925-104 HUMAN PRESCRIPTION DRUG Se-Care Chewable ascorbic acid, calcium threonate, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, calcium carbonate, ferrous fumarate, magnesium oxide, zinc oxide and cupric ox TABLET, CHEWABLE ORAL 20090501 UNAPPROVED DRUG OTHER Seton Pharmaceuticals .ALPHA.-TOCOPHEROL ACETATE, DL-; CALCIUM ASCORBATE; CALCIUM CARBONATE; CALCIUM THREONATE; CHOLECALCIFEROL; CUPRIC OXIDE; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE; ZINC OXIDE 3.5; 50; 250; 50; 6; 2; 40; 1; 50; 2; 15 [iU]/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 13925-107_d21a1fdb-7111-4038-975f-f93de44d63a7 13925-107 HUMAN PRESCRIPTION DRUG Methenamine Mandelate Methenamine Mandelate TABLET, FILM COATED ORAL 20100201 UNAPPROVED DRUG OTHER Seton Pharmaceuticals METHENAMINE MANDELATE 1000 mg/1 13925-114_3a630abe-c61f-4f76-85ef-a6ca42f7d406 13925-114 HUMAN PRESCRIPTION DRUG SE 10-5 SS SODIUM SULFACETAMIDE, SULFUR CREAM TOPICAL 20100515 20150115 UNAPPROVED DRUG OTHER Seton Pharmaceuticals SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 13925-116_f6e296c6-2c66-4306-870e-b5a5b25296b9 13925-116 HUMAN PRESCRIPTION DRUG Se-Natal 19 .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, zinc oxide and docusate sodium TABLET ORAL 20090701 UNAPPROVED DRUG OTHER Seton Pharmaceuticals .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE; ZINC OXIDE 30; 1000; 100; 200; 7; 400; 12; 25; 29; 1; 15; 20; 3; 3; 20 mg/1; [iU]/1; mg/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 13925-117_c1fbc523-f64b-487e-832b-5ebdb84321b1 13925-117 HUMAN PRESCRIPTION DRUG Se-Natal 19 Chewable Vitamins and Minerals TABLET, CHEWABLE ORAL 20090701 UNAPPROVED DRUG OTHER Seton Pharmaceuticals .ALPHA.-TOCOPHEROL ACETATE, DL-; BETA CAROTENE; CALCIUM ASCORBATE; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 30; 1000; 100; 200; 7; 400; 12; 29; 1; 15; 20; 3; 3; 20 [iU]/1; [iU]/1; mg/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 13925-118_56e912df-3a49-4405-8df1-7b80d12bd920 13925-118 HUMAN PRESCRIPTION DRUG Se-Tan PLUS MULTIVITAMIN/MINERAL CAPSULE, GELATIN COATED ORAL 20091001 UNAPPROVED DRUG OTHER Seton Pharmaceuticals CALCIUM PANTOTHENATE; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; IRON DEXTRAN; MANGANESE SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE 10; .8; 15; 162; 1; 115.2; 1.3; 30; 5; 6; 200; 10; 18.2 mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 13925-119_cf61f2c7-9b81-4dcc-8648-45076c123de1 13925-119 HUMAN PRESCRIPTION DRUG Se-Tan DHA Ferrous Fumarate and Polysaccharide Iron CAPSULE, GELATIN COATED ORAL 20091001 UNAPPROVED DRUG OTHER Seton Pharmaceuticals DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; ICOSAPENT; IRON DEXTRAN; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; SODIUM ASCORBATE 215.12; 15; 1; 53.46; 15; 310.1; 25; 20 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] 13925-121_26626fee-9ec0-4ddb-ac02-db0ddfc5210f 13925-121 HUMAN PRESCRIPTION DRUG SE BPO Benzoyl Peroxide KIT 20101004 UNAPPROVED DRUG OTHER Seton Pharmaceuticals 13925-122_1adbbcd3-9e80-4417-afe9-44c80f10eb52 13925-122 HUMAN PRESCRIPTION DRUG Cavan-EC SOD DHA Beta Carotene, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, DL-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Iron, Magnesium Oxide, Zinc Oxide, Cupric Oxide, Iodine, Omega-3 Fatty Acids KIT ORAL 20100110 UNAPPROVED DRUG OTHER Seton Pharmaceuticals 13925-127_42d6801b-80f1-4f09-a661-6d64e2f93a0e 13925-127 HUMAN PRESCRIPTION DRUG Cavan Alpha Beta Carotene, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, DL-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, KIT ORAL 20100701 UNAPPROVED DRUG OTHER Seton Pharmaceuticals 13925-157_5c57a310-8d46-4862-bf2a-a7e4fd5bee57 13925-157 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Hydrocortisone Acetate Lidocaine Hydrochloride and Hydrocortisone Acetate CREAM RECTAL 20110617 UNAPPROVED DRUG OTHER Seton Pharmaceuticals HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE 5; 30 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 13925-158_835d720c-0bbc-46f0-8984-e4d16ec013c9 13925-158 HUMAN PRESCRIPTION DRUG SE-DONNA PB HYOS Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide ELIXIR ORAL 20110509 UNAPPROVED DRUG OTHER Seton Pharmaceuticals ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] CIV 13925-159_7100b5da-0cc3-41ff-aa00-db441fd2f2e7 13925-159 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride CREAM TOPICAL 20110620 UNAPPROVED DRUG OTHER Seton Pharmaceuticals LIDOCAINE HYDROCHLORIDE 30 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 13925-160_7a664a34-19fd-4a7b-ab4d-11299b32999e 13925-160 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Hydrocortisone Acetate Lidocaine Hydrochloride and Hydrocortisone Acetate CREAM TOPICAL 20110617 UNAPPROVED DRUG OTHER Seton Pharmaceuticals HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE 5; 30 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 13925-161_74f259fb-0171-45ae-aabc-e663e7c9893c 13925-161 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide and Sulfur Sodium Sulfacetamide and Sulfur SOLUTION TOPICAL 20110527 UNAPPROVED DRUG OTHER Seton Pharmaceuticals SULFACETAMIDE; SULFUR 100; 50 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 13925-163_951862db-3a73-4d25-9d5b-e4111833f43b 13925-163 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Hydrocortisone Acetate Lidocaine Hydrochloride and Hydrocortisone Acetate CREAM RECTAL 20110617 UNAPPROVED DRUG OTHER Seton Pharmaceuticals HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE 10; 30 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 13925-164_fd6343a9-15a6-4894-b51f-122e4d6dbe79 13925-164 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Hydrocortisone Acetate Lidocaine Hydrochloride and Hydrocortisone Acetate GEL RECTAL 20110617 UNAPPROVED DRUG OTHER Seton Pharmaceuticals HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE 25; 30 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 13925-165_6aa284d6-0212-4fb5-809d-c721aa6fe2ba 13925-165 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Hydrocortisone Acetate Lidocaine Hydrochloride and Hydrocortisone Acetate CREAM RECTAL 20110617 UNAPPROVED DRUG OTHER Seton Pharmaceuticals HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE 5; 30 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 13925-166_091ad63b-768b-4db4-a465-c90f975b139d 13925-166 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20131018 NDA NDA019157 Seton Pharmaceuticals, LLC PREDNISOLONE SODIUM PHOSPHATE 5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 13925-167_32130bf3-cb1c-4c45-95f9-48b47fa2462c 13925-167 HUMAN PRESCRIPTION DRUG Multi Vitamin Drops with Fluoride vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol succinate, d-thiamine hydrochloride, riboflavin 5-phosphate sodium, cyanocobalamin, niacinamide, pyridoxine hydrochloride and sodium fluoride SOLUTION/ DROPS ORAL 20140418 UNAPPROVED DRUG OTHER Seton Pharmaceuticals .ALPHA.-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE 5; 35; 400; 2; 8; .4; .6; .25; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 13925-168_bb6a961a-37df-4f0c-9871-2971b0f57bd4 13925-168 HUMAN PRESCRIPTION DRUG Multi Vitamin Drops with Fluoride vitamin a palmitate, ascorbic acid, cholecalciferol, alpha.-tocopherol succinate, d- thiamine hydrochloride, riboflavin 5-phosphate sodium, cyanocobalamin, niacinamide, pyridoxine hydrochloride and sodium fluoride SOLUTION/ DROPS ORAL 20140418 UNAPPROVED DRUG OTHER Seton Pharmaceuticals .ALPHA.-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE 5; 35; 400; 2; 8; .4; .6; .5; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 13925-169_9dbc0e00-697c-4ef6-8658-a810c2008f31 13925-169 HUMAN PRESCRIPTION DRUG Multi Vitamin Drops with Fluoride and Iron vitamin a palmitate, ascorbic acid, cholecalciferol, alpha.-tocopherol succinate, d- thiamine hydrochloride, riboflavin 5-phosphate sodium, niacinamide, pyridoxine hydrochloride, ferrous sulfate and sodium fluoride SOLUTION/ DROPS ORAL 20140418 UNAPPROVED DRUG OTHER Seton Pharmaceuticals .ALPHA.-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; FERROUS SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE 5; 35; 400; 10; 8; .4; .6; .25; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 13925-170_752ce1a8-6b66-4a34-bfee-e81d871bbfb4 13925-170 HUMAN PRESCRIPTION DRUG Triple-Vitamin Drops with Fluoride Vitamins A, C, D and Fluoride SOLUTION/ DROPS ORAL 20140411 UNAPPROVED DRUG OTHER Seton Pharmaceuticals ASCORBIC ACID; CHOLECALCIFEROL; SODIUM FLUORIDE; VITAMIN A PALMITATE 35; 400; .25; 1500 mg/mL; [iU]/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 13925-171_0f7292dc-9d7d-4212-9396-6f0044cf9765 13925-171 HUMAN PRESCRIPTION DRUG Esterified Estrogens and Methyltestosterone Esterified Estrogens and Methyltestosterone TABLET, FILM COATED ORAL 20051010 UNAPPROVED DRUG OTHER Seton Pharmaceuticals ESTROGENS, CONJUGATED; METHYLTESTOSTERONE .625; 1.25 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 13925-172_0f7292dc-9d7d-4212-9396-6f0044cf9765 13925-172 HUMAN PRESCRIPTION DRUG Esterified Estrogens and Methyltestosterone Esterified Estrogens and Methyltestosterone TABLET, FILM COATED ORAL 20100505 UNAPPROVED DRUG OTHER Seton Pharmaceuticals ESTROGENS, CONJUGATED; METHYLTESTOSTERONE 1.25; 2.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 13925-501_2d706b2f-95fd-439b-863b-862c242ed79f 13925-501 HUMAN PRESCRIPTION DRUG PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION ORAL 20030326 ANDA ANDA075183 Seton Pharmaceuticals PREDNISOLONE SODIUM PHOSPHATE 5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 13925-506_a25d66f9-01c4-4520-b134-b1ea7657838a 13925-506 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide OIL TOPICAL 20130820 NDA AUTHORIZED GENERIC NDA019452 Seton Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 13925-507_16e3bb49-35e7-40b9-9004-58f17a71dea6 13925-507 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide OIL TOPICAL 20130801 NDA AUTHORIZED GENERIC NDA019452 Seton Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 13925-508_2c23c6de-fb0a-4146-828a-2f96aef80001 13925-508 HUMAN PRESCRIPTION DRUG Fluocinolone acetonide 0.01% fluocinolone acetonide OIL AURICULAR (OTIC) 20130801 NDA AUTHORIZED GENERIC NDA019452 Seton Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 13925-509_47c8ecc5-499d-4936-84b0-6fba15140721 13925-509 HUMAN PRESCRIPTION DRUG Prenatal Plus .beta.-carotene, sodium acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide and cupric oxide TABLET ORAL 20140307 UNAPPROVED DRUG OTHER Seton Pharmaceuticals LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ACETATE; THIAMINE MONONITRATE; ZINC OXIDE 22; 2000; 120; 200; 400; 2; 12; 27; 1; 20; 10; 3; 2000; 1.84; 25 mg/1; [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 13985-013_691ac9bb-9d7d-42de-bb89-6093341b1cc4 13985-013 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20100831 OTC MONOGRAPH FINAL part349 MWI/VetOne WATER 99.05 mL/100mL 13985-014_8d55dfcf-788d-4504-aebd-afcc98c81345 13985-014 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate, and Dexamethasone OINTMENT OPHTHALMIC 19940725 ANDA ANDA064063 MWI/VetOne DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 13985-016_10195234-e8c4-455a-9e27-0333f454ea3f 13985-016 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone OINTMENT OPHTHALMIC 19951030 ANDA ANDA064068 MWI/VetOne BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 10; 3.5; 10000 [USP'U]/g; mg/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 13985-025_dbcab023-8a71-4c66-ac6b-b98b20a493f9 13985-025 HUMAN PRESCRIPTION DRUG PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS OPHTHALMIC 19940729 ANDA ANDA040070 MWI/VetOne PREDNISOLONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 13985-028_01e58ae0-cdcf-4c1f-bfb9-9d0fc3ebd002 13985-028 HUMAN PRESCRIPTION DRUG Neomycin Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19950913 ANDA ANDA064135 MWI/VetOne DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 13985-529_06caa424-56ef-4b31-a226-14db9ee4a457 13985-529 HUMAN OTC DRUG Veti-Foam Benzethonium Chloride LIQUID TOPICAL 20100726 OTC MONOGRAPH NOT FINAL part333A MWI/Vet One BENZETHONIUM CHLORIDE 2 g/L 13992-001_27f7b52b-4384-4cf2-9723-16c5b610247b 13992-001 HUMAN OTC DRUG Colic Calm Aloe Socotrina, Carbo Vegetabilis, Carum Carvi, Chamomilla, Foeniculum Vulgare, Melissa Officinalis, Mentha Piperita, Prunus Spinosa and Zingiber Officinale LIQUID ORAL 20070108 UNAPPROVED HOMEOPATHIC TJL Enterprises Inc. ACTIVATED CHARCOAL; ALOE; CARAWAY OIL; CHAMOMILE; FENNEL SEED; GINGER; MELISSA OFFICINALIS; MENTHA PIPERITA; PRUNUS SPINOSA FLOWER BUD 1; 5; 5; 5; 5; 5; 5; 5; 5 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 13992-003_7f9b8aa6-922d-4e45-b7e2-56eef4c80b22 13992-003 HUMAN OTC DRUG Tummy Calm Calcarea Phosphorica, Carbo Vegetabilis, Chamomilla, Colocynthis, Lycopodium, Moschus, Natrum Muriaticum, Silicea, Thuja LIQUID ORAL 20120525 UNAPPROVED HOMEOPATHIC TJL Enterprises Inc. ACTIVATED CHARCOAL; CHAMOMILE; CITRULLUS COLOCYNTHIS FRUIT; ESCHERICHIA COLI; LYCOPODIUM COMPLANATUM WHOLE; MOSCHUS MOSCHIFERUS WHOLE; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAF; TRIBASIC CALCIUM PHOSPHATE 2; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 14049-464_13865382-306b-40b2-8286-0a15cf28f76a 14049-464 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 19951030 ANDA ANDA064064 RXV BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 10000 [USP'U]/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] 14049-466_6dc7154e-2173-4dd1-baf0-0f45af6f68c2 14049-466 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate, and Dexamethasone OINTMENT OPHTHALMIC 19940725 ANDA ANDA064063 RXV DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 14049-467_361fd3cd-4e84-46e6-a05a-da600a539239 14049-467 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone OINTMENT OPHTHALMIC 19951030 ANDA ANDA064068 RXV BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 10; 3.5; 10000 [USP'U]/g; mg/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 14049-830_16bb81d6-a9e3-47b0-9cc5-c41fe3ef86a6 14049-830 HUMAN PRESCRIPTION DRUG Neomycin Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19950913 ANDA ANDA064135 RXV DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 14051-221_cb21905c-653f-47a4-81c6-ff51f9c0e68f 14051-221 HUMAN OTC DRUG Care ALCOHOL GEL TOPICAL 20051101 OTC MONOGRAPH NOT FINAL part333E Top Chemical Co., Inc. ALCOHOL .7 mL/mL 14060-002_5f8cf513-110b-4858-98d9-d46aa71cb064 14060-002 HUMAN PRESCRIPTION DRUG BeeGentle Topical Anesthetic benzocaine GEL TOPICAL 20100901 UNAPPROVED DRUG OTHER CAO Group, Inc. BENZOCAINE 210 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 14060-003_26909161-a24d-4af7-8613-98499621d219 14060-003 HUMAN PRESCRIPTION DRUG SheerDesenZ Desensitizing Treatment potassium nitrate FILM DENTAL 20100901 UNAPPROVED DRUG OTHER CAO Group, Inc. POTASSIUM NITRATE 12 mg/1 14060-005_5792739d-dbf0-494c-aacc-d4cce115ff1e 14060-005 HUMAN PRESCRIPTION DRUG SheerFluorX Fluoride Treatment sodium fluoride FILM DENTAL 20100901 UNAPPROVED DRUG OTHER CAO Group, Inc. SODIUM FLUORIDE 20 mg/1 14060-006_2d80d192-c627-4b95-bb86-dcb5949e6cdc 14060-006 HUMAN PRESCRIPTION DRUG Sheer FluorX PEDO Fluoride Treatment sodium fluoride FILM DENTAL 20110415 UNAPPROVED DRUG OTHER CAO Group, Inc. SODIUM FLUORIDE 20 mg/1 14060-010_0b2fffc7-c223-49c6-9b90-541cedff754e 14060-010 HUMAN PRESCRIPTION DRUG FastStat Topical Hemostat ferric sulfate GEL INTRAGINGIVAL 20100901 UNAPPROVED DRUG OTHER CAO Group, Inc. FERRIC SULFATE 142 mg/g Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 14208-532_a7ab4b69-3def-4b86-9810-044ebf69a91e 14208-532 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19760101 UNAPPROVED MEDICAL GAS California Tool and Welding Supply, LLC OXYGEN 99 L/100L 14209-585_8d759134-8e80-4cb6-819a-cb0e3dee4cfd 14209-585 HUMAN OTC DRUG Germ Safe ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333 Original 7, Inc. ALCOHOL .7 mL/mL 14209-855_4273876b-6850-4d78-9b44-7299890ed2b1 14209-855 HUMAN OTC DRUG Germ Safe ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333E Original 7, Inc. ALCOHOL .62 mL/mL 14214-0123_a5ceacd0-05a2-44a4-a5aa-5dc0e14a8bdf 14214-0123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Leading Respiratory Service Inc. OXYGEN 99 L/100L 14222-0000_49483647-5cf3-4fee-82e6-9b6fe4926086 14222-0000 HUMAN OTC DRUG RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30 TITANIUM DIOXIDE CREAM TOPICAL 20130603 OTC MONOGRAPH NOT FINAL part352 Rodan & Fields TITANIUM DIOXIDE; ZINC OXIDE 20; 120 mg/mL; mg/mL 14222-0001_5e76238d-b875-4262-b266-d45e8ef4fd39 14222-0001 HUMAN OTC DRUG RODAN - FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part352 Rodan & Fields AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 70; 40; 17 mg/mL; mg/mL; mg/mL; mg/mL 14222-0420_fbf9edbb-b711-429a-a332-e2795d534aa1 14222-0420 HUMAN OTC DRUG RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50 PLUS SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 Rodan & Fields AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 26 mg/mL; mg/mL; mg/mL; mg/mL 14222-1615_c6954fc7-c178-41e7-895d-5b71f8f9b657 14222-1615 HUMAN OTC DRUG Skin Lightening Rodan Fields HYDROQUINONE LIQUID TOPICAL 20110606 OTC MONOGRAPH NOT FINAL part358A Rodan & Fields, LLC. HYDROQUINONE 2 mL/100mL 14222-1900_159c10e7-8f85-4ab3-8d6b-9a47513cb21e 14222-1900 HUMAN OTC DRUG Unblemish Hydroquinone LIQUID TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part358A Rodan + Fields LLC HYDROQUINONE 2 g/100mL 14222-2000_68438a63-4972-4752-9322-27e597047354 14222-2000 HUMAN OTC DRUG Unblemish Benzoyl Peroxide LOTION TOPICAL 20140601 OTC MONOGRAPH FINAL part333D Rodan & Fields, LLC BENZOYL PEROXIDE 50 mg/mL 14222-2003_13cef1df-4845-4601-9939-9816d37879ac 14222-2003 HUMAN OTC DRUG Soothe Rodan Fields HYDROCORTISONE LOTION TOPICAL 20110607 OTC MONOGRAPH NOT FINAL part348 Rodan & Fields, LLC. HYDROCORTISONE 1 mL/100mL 14222-2022_44be628e-fe1d-4061-a3b2-5f1b72fb383b 14222-2022 HUMAN OTC DRUG UVA/UVB SPF 15 Rodan and Fields Octinoxate, Zinc Oxide LOTION TOPICAL 20110603 OTC MONOGRAPH NOT FINAL part352 Rodan & Fields LLC. OCTINOXATE; ZINC OXIDE 7.5; 3.4 mL/100mL; mL/100mL 14222-2050_d6a87ab5-3dea-459a-9c53-f02ce0dc0c44 14222-2050 HUMAN OTC DRUG Acne Treatment Sulfur Wash Rodan and Field SULFUR LIQUID TOPICAL 20110608 OTC MONOGRAPH FINAL part358H Rodan & Fields, LLC. SULFUR 3 g/100mL 14222-2240_19a2f9e7-2c68-4631-9746-d110100af8a9 14222-2240 HUMAN OTC DRUG Rodan and Fields Redefine Age Shield Hand Shield Balm SPF30 Octisalate, Avobenzone, Homosalate, Octocrylene EMULSION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Rodan and Fields AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 2.5; 5; 2.7 g/100g; g/100g; g/100g; g/100g 14222-2250_a24b6a6f-1719-4bda-bc4c-917db1c74bcb 14222-2250 HUMAN OTC DRUG Rodan and Fields Redefine AM SPF 30 Octisalate, Avobenzone, Octocrylene, Homosalate CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part352 Rodan and Fields AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 2.5; 5; 2.7 g/100mL; g/100mL; g/100mL; g/100mL 14222-425_04b587d3-dc74-4b82-b07a-fae977c2af90 14222-425 HUMAN OTC DRUG Rodan And Fields Essentials Lip Shield SPF 25 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIPSTICK TOPICAL 20110621 OTC MONOGRAPH FINAL part352 Rodan & Fields AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 8; 5; 2.2 g/100g; g/100g; g/100g; g/100g 14222-429_d06c39b2-0fa8-4efb-b067-6f56a03201d7 14222-429 HUMAN OTC DRUG Rodan and Fields Skin Lightening Treatment Hydroquinone CREAM TOPICAL 20110607 OTC MONOGRAPH NOT FINAL part358A Rodan & Fields LLC. HYDROQUINONE 2 mL/100mL 14290-281_d50a6e20-da36-485a-a2f0-5112c14cf484 14290-281 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20090407 NDA NDA075213 Triax Pharmaceuticals, LLC TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 14290-282_d50a6e20-da36-485a-a2f0-5112c14cf484 14290-282 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20090310 NDA NDA075265 Triax Pharmaceuticals, LLC TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 14290-283_d50a6e20-da36-485a-a2f0-5112c14cf484 14290-283 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20090316 NDA NDA075264 Triax Pharmaceuticals, LLC TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 14290-313_e7a9f6eb-2b73-41fa-b4ce-1a3f0bd09d94 14290-313 HUMAN PRESCRIPTION DRUG Locoid Lipocream hydrocortisone butyrate CREAM TOPICAL 20081001 20150831 NDA NDA020769 Triax Pharmaceuticals, LLC HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 14290-314_a8587a3c-0912-4754-b8eb-62b2d21bc4b7 14290-314 HUMAN PRESCRIPTION DRUG Locoid hydrocortisone butyrate LOTION TOPICAL 20080708 20150430 NDA NDA022076 Triax Pharmaceuticals, LLC HYDROCORTISONE BUTYRATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 14290-350_a2659388-7918-4af9-8963-e8f924a6da0e 14290-350 HUMAN PRESCRIPTION DRUG Tretin-X tretinoin CREAM TOPICAL 20060401 20150731 ANDA ANDA075213 Triax Pharmaceuticals, LLC TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 14290-351_a2659388-7918-4af9-8963-e8f924a6da0e 14290-351 HUMAN PRESCRIPTION DRUG Tretin-X tretinoin CREAM TOPICAL 20060401 20150731 ANDA ANDA075265 Triax Pharmaceuticals, LLC TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 14290-352_a2659388-7918-4af9-8963-e8f924a6da0e 14290-352 HUMAN PRESCRIPTION DRUG Tretin-X tretinoin CREAM TOPICAL 20060401 20150731 ANDA ANDA075264 Triax Pharmaceuticals, LLC TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 14290-353_a2659388-7918-4af9-8963-e8f924a6da0e 14290-353 HUMAN PRESCRIPTION DRUG Tretin-X tretinoin GEL TOPICAL 20060401 20150731 ANDA ANDA075529 Triax Pharmaceuticals, LLC TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 14290-354_a2659388-7918-4af9-8963-e8f924a6da0e 14290-354 HUMAN PRESCRIPTION DRUG Tretin-X tretinoin GEL TOPICAL 20060401 20150731 ANDA ANDA075589 Triax Pharmaceuticals, LLC TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 14290-375_6270850f-13d7-4c3b-b313-724677688b39 14290-375 HUMAN PRESCRIPTION DRUG Tretin-X tretinoin CREAM TOPICAL 20100801 20150731 ANDA ANDA075213 Triax Pharmaceuticals, LLC TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 14290-376_6270850f-13d7-4c3b-b313-724677688b39 14290-376 HUMAN PRESCRIPTION DRUG Tretin-X tretinoin CREAM TOPICAL 20100801 20150731 ANDA ANDA075264 Triax Pharmaceuticals, LLC TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 14290-377_6270850f-13d7-4c3b-b313-724677688b39 14290-377 HUMAN PRESCRIPTION DRUG Tretin-X tretinoin CREAM TOPICAL 20100801 20150731 ANDA ANDA075265 Triax Pharmaceuticals, LLC TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 14290-378_6270850f-13d7-4c3b-b313-724677688b39 14290-378 HUMAN PRESCRIPTION DRUG Tretin-X tretinoin GEL TOPICAL 20100801 20150731 ANDA ANDA075529 Triax Pharmaceuticals, LLC TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 14290-379_6270850f-13d7-4c3b-b313-724677688b39 14290-379 HUMAN PRESCRIPTION DRUG Tretin-X tretinoin GEL TOPICAL 20100801 20150731 ANDA ANDA075589 Triax Pharmaceuticals, LLC TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 14290-381_6270850f-13d7-4c3b-b313-724677688b39 14290-381 HUMAN PRESCRIPTION DRUG Tretin-X tretinoin CREAM TOPICAL 20100801 20150731 ANDA ANDA090098 Triax Pharmaceuticals, LLC TRETINOIN .375 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 14290-500_c6474d83-8547-493d-b72f-ad67c1137b0c 14290-500 HUMAN PRESCRIPTION DRUG Minocin minocycline hydrochloride CAPSULE, COATED PELLETS ORAL 20070901 20150831 NDA NDA050649 Triax Pharmaceuticals, LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 14290-501_c6474d83-8547-493d-b72f-ad67c1137b0c 14290-501 HUMAN PRESCRIPTION DRUG Minocin minocycline hydrochloride CAPSULE, COATED PELLETS ORAL 20070901 20150831 NDA NDA050649 Triax Pharmaceuticals, LLC MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 14290-570_a7d1da04-7985-4b15-9d53-e5ee7aade4f4 14290-570 HUMAN PRESCRIPTION DRUG Minocin Kit minocycline hydrochloride CAPSULE, COATED PELLETS ORAL 20070901 20160131 NDA NDA050649 Triax Pharmaceuticals, LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 14290-571_a7d1da04-7985-4b15-9d53-e5ee7aade4f4 14290-571 HUMAN PRESCRIPTION DRUG Minocin Kit minocycline hydrochloride CAPSULE, COATED PELLETS ORAL 20070901 20160131 NDA NDA050649 Triax Pharmaceuticals, LLC MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 14319-3118_a4f660cb-f504-4f9c-9c3b-5cb4faf0d07a 14319-3118 HUMAN OTC DRUG Plaster MandAHerbalPlaster Menthol PATCH TOPICAL 20050425 OTC MONOGRAPH NOT FINAL part348 Dah Wei Chem & Pharm Co., Ltd. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE; MYRRH; SESAME OIL .24; 1.2; 1.5; .9; 3 g/30g; g/30g; g/30g; g/30g; g/30g 14362-0111_7b877715-e4f5-454d-8985-885dcff96360 14362-0111 VACCINE Tetanus and Diphtheria Toxoids Adsorbed Tetanus and Diphtheria Toxoids Adsorbed INJECTION INTRAMUSCULAR 19700727 BLA BLA101322 MassBiologics CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2; 2 [Lf]/.5mL; [Lf]/.5mL Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient] 14505-398_cb6c6e0c-0ae5-4c15-bbe2-0c2801106723 14505-398 HUMAN OTC DRUG Sanatos Day Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine LIQUID ORAL 20100204 OTC MONOGRAPH FINAL part341 Pharmalab Enterprises Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 14505-399_af1e5459-2fd9-4c0f-af63-bea42e73c14d 14505-399 HUMAN OTC DRUG Sanatos Night Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20100204 OTC MONOGRAPH FINAL part341 Pharmalab Enterprises Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 14505-400_f7ff7fd5-9d0e-465c-8440-c84ab2fd23d1 14505-400 HUMAN OTC DRUG Desempacho Cucharadas Bismuth Subsalicylate LIQUID ORAL 20090109 OTC MONOGRAPH FINAL part335 Pharmalab Enterprises Inc. BISMUTH SUBSALICYLATE 262 mg/15mL 14505-488_0f4bf76c-85e8-4941-91a8-ef14fedab1b7 14505-488 HUMAN OTC DRUG Bisolvine Child Guaifenesin, Dextromethorphan LIQUID ORAL 20100218 OTC MONOGRAPH FINAL part341 Pharmalab Enterprises Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 100; 10 mg/5mL; mg/5mL 14537-408_22902890-27c0-4276-9e6b-e0031a25de96 14537-408 HUMAN PRESCRIPTION DRUG Isoplate SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE, MONOBASIC SOLUTION INTRAVENOUS 20130305 NDA BN090067 Terumo BCT Ltd. MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC .03; .037; .00082; .37; .53; .5; .012 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 14537-966_af4cef32-30bd-4471-baec-21f36bb7b06f 14537-966 HUMAN PRESCRIPTION DRUG AS 3 Dextrose Monohydrate, Sodium Citrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate and Adenine INJECTION, SOLUTION INTRAVENOUS 20020529 NDA BN001214 Terumo BCT Ltd ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM CITRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .03; .042; 1.1; .41; .588; .276 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 14537-967_66e7629c-27ad-4a39-982d-1c56e38156b6 14537-967 HUMAN PRESCRIPTION DRUG ACD A Dextrose Monohydrate, Sodium Citrate, and Citric Acid Monohydrate INJECTION, SOLUTION INTRAVENOUS 20020225 ANDA BA010228 Terumo BCT Ltd CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE .8; 2.45; 2.2 g/100mL; g/100mL; g/100mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 14539-150_ca67721d-0287-46d2-bffe-83748f21f6fd 14539-150 HUMAN PRESCRIPTION DRUG POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20110928 ANDA ANDA202071 Emcure Pharmaceuticals USA Inc. POLYETHYLENE GLYCOL 3350 17 g/1 Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 14550-511_80a68ba3-10c2-41da-a521-2290c669071b 14550-511 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 Actavis Pharma Manufacturing Pvt Ltd. (SOD) GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 14550-512_80a68ba3-10c2-41da-a521-2290c669071b 14550-512 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 Actavis Pharma Manufacturing Pvt Ltd. (SOD) GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 14550-513_80a68ba3-10c2-41da-a521-2290c669071b 14550-513 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 Actavis Pharma Manufacturing Pvt Ltd. (SOD) GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 14550-517_e77e640b-d633-4cb4-8ebf-adbf5f35cc43 14550-517 HUMAN PRESCRIPTION DRUG Glyburide (micronized) and Metformin Hydrochloride Glyburide (micronized) and Metformin Hydrochloride TABLET ORAL 20100503 ANDA ANDA076716 Actavis Pharma Manufacturing Pvt. Ltd. GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 14550-518_e77e640b-d633-4cb4-8ebf-adbf5f35cc43 14550-518 HUMAN PRESCRIPTION DRUG Glyburide (micronized) and Metformin Hydrochloride Glyburide (micronized) and Metformin Hydrochloride TABLET ORAL 20100503 ANDA ANDA076716 Actavis Pharma Manufacturing Pvt. Ltd. GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 14550-519_e77e640b-d633-4cb4-8ebf-adbf5f35cc43 14550-519 HUMAN PRESCRIPTION DRUG Glyburide (micronized) and Metformin Hydrochloride Glyburide (micronized) and Metformin Hydrochloride TABLET ORAL 20100503 ANDA ANDA076716 Actavis Pharma Manufacturing Pvt. Ltd. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 14593-124_17bc96cc-3486-4bc3-84e6-89497789f8f1 14593-124 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION INTRAVENOUS 20091117 ANDA ANDA090125 Emcure Pharmaceuticals Ltd. NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 14720-371_a16a9ff7-c2a9-4f17-bdb5-4bdb2eba1608 14720-371 HUMAN OTC DRUG Double Prawn Rumagon Methyl Salicylate, Turpentine LINIMENT TOPICAL 20010805 OTC MONOGRAPH FINAL part348 Tai Tong Ah Co., Pte. Ltd. METHYL SALICYLATE; TURPENTINE 16.8; 6.72 mL/28mL; mL/28mL 14720-372_53601099-5e12-4e1a-82dc-2fc3f08128fa 14720-372 HUMAN OTC DRUG Double Prawn Brand Herbal Oil Benzocaine, Menthol OIL TOPICAL 20041227 OTC MONOGRAPH FINAL part346 Tai Tong Ah Co Pte Ltd MENTHOL 3.5 g/100mL 14743-085_4b2388c5-2f23-4310-ba03-b3f996688063 14743-085 HUMAN OTC DRUG Tahitian Noni TePoema Element Shield SPF 20 Avobenzone, Octinoxate, Octisalate LOTION TOPICAL 20051101 OTC MONOGRAPH NOT FINAL part352 Tahitian Noni International Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 2; 7.5; 5 g/100mL; g/100mL; g/100mL 14743-101_ac5ca9c1-a023-460f-9205-d85acd25aad8 14743-101 HUMAN OTC DRUG Tahitian Noni Lip Balm Berry SPF15 Octinoxate, Oxybenzone OINTMENT TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 Tahitian Noni International Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 14743-102_a3582f7b-364d-45db-bfd6-dd120591e209 14743-102 HUMAN OTC DRUG Tahitian Noni Lip Balm Pineapple SPF15 Octinoxate, Oxybenzone OINTMENT TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 Tahitian Noni International Inc OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 14743-103_d6bcfaa1-fb92-4e26-991e-7d070dc099f4 14743-103 HUMAN OTC DRUG Tahitian Noni Original Lip Balm SPF15 Octinoxate, Oxybenzone OINTMENT TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 Tahitian Noni International OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 14743-536_685c76f8-dc8c-4e84-9638-fbd1f81ea7f5 14743-536 HUMAN OTC DRUG Tahitian Noni Sunscreen SPF 30 Avobenzone, Homosalate, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100628 OTC MONOGRAPH NOT FINAL part352 Tahitian Noni International AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 6.5; 7; 5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 14783-010_877ec1e1-4c0f-4f81-8e13-6ecd30955e91 14783-010 HUMAN OTC DRUG LBEL EFFET PARFAIT Signs of age appearance minimizer foundation SPF 20 Octinoxate and Titanium Dioxide LOTION TOPICAL 20120914 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; TITANIUM DIOXIDE .07; .024 g/mL; g/mL 14783-011_c3d86ea0-9722-4082-9fdf-2d3ac62b60f3 14783-011 HUMAN OTC DRUG LBEL EFFET PARFAIT OCTINOXATE, OXYBENZONE, and TITANIUM DIOXIDE LIPSTICK TOPICAL 20101215 OTC MONOGRAPH NOT FINAL part352 Ventura International, Limited OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .03; .008 g/g; g/g; g/g 14783-012_ddb9f3ce-cb3c-41cb-9b16-db887cdcb0e3 14783-012 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20120914 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-013_40004acb-f09e-4a93-a249-c80242ed8804 14783-013 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL TITANIUM DIOXIDE, OXYBENZONE, ZINC OXIDE, and OCTINOXATE POWDER TOPICAL 20101215 OTC MONOGRAPH NOT FINAL part352 Ventura International, Limited OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE .035; .05; .06; .049 g/g; g/g; g/g; g/g 14783-014_964c3114-9322-4965-9d9a-4b9a04fb5ef1 14783-014 HUMAN OTC DRUG LBEL LEDERM 35plus Jour SPF 15 Facial Treatment Against First Signs of Aging Day - Oily Skin Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura International LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g 14783-015_33568657-22d1-46b1-873d-fa17bfe7a3af 14783-015 HUMAN OTC DRUG LBEL LEDERM 35plus Jour SPF 15 Facial Treatment Against First Signs of Aging Day - Normal to Dry Skin Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura International LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g 14783-016_46183f7d-7b25-4156-a87f-ee6a2a113702 14783-016 HUMAN OTC DRUG LBEL LEDERM 45plus Jour SPF 15 Facial Treatment Against Noticeable Signs of Aging Day - Oily Skin Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura International LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g 14783-017_c5c5d096-9509-4435-95e8-8487cf7a12a1 14783-017 HUMAN OTC DRUG LBEL LEDERM 45plus Jour SPF 15 Facial Treatment Against Noticeable Signs of Aging Day - Normal to Dry Skin Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura International LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g 14783-018_0c3c71b9-8f8d-4de9-8fe4-04a2cb405093 14783-018 HUMAN OTC DRUG LBel Paris Renovance Jour Octinoxate, Octocrylene, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTOCRYLENE; OXYBENZONE .075; .05; .03 g/g; g/g; g/g 14783-019_f5ff921a-c276-4658-9cb2-95333590cd80 14783-019 HUMAN OTC DRUG LBEL LEDERM 55plus Jour SPF 15 Facial Treatment Against Advanced Signs of Aging Day - All Skin Types Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura International LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g 14783-025_8bb9e858-d994-4a1a-80d2-777a2dfba3e2 14783-025 HUMAN OTC DRUG LBEL REGRESSION JOUR Protective Complex with SPF 15 Facial day normal to dry skin Avobenzone, Ensulizole, Octinoxate, and Oxybenzone CREAM TOPICAL 20120514 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. AVOBENZONE; ENSULIZOLE; OCTINOXATE; OXYBENZONE .02; .01; .075; .02 g/g; g/g; g/g; g/g 14783-028_0c3c71b9-8f8d-4de9-8fe4-04a2cb405093 14783-028 HUMAN OTC DRUG LBel Paris Renovance Jour Octinoxate, Octocrylene, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTOCRYLENE; OXYBENZONE .375; .25; .15 g/5g; g/5g; g/5g 14783-029_cc68be31-6278-4868-b80a-c67096627a83 14783-029 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Claire 1-2-3 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 14783-030_cc68be31-6278-4868-b80a-c67096627a83 14783-030 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Claire 4 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 14783-031_cc68be31-6278-4868-b80a-c67096627a83 14783-031 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Medium 5 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 14783-032_cc68be31-6278-4868-b80a-c67096627a83 14783-032 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Medium 6 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 14783-033_cc68be31-6278-4868-b80a-c67096627a83 14783-033 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Medium 7 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 14783-034_cc68be31-6278-4868-b80a-c67096627a83 14783-034 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Obscure 8-9 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 14783-035_4922ce2e-1697-4239-a440-41c84aa55b30 14783-035 HUMAN OTC DRUG LBel Paris Regression Jour Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTISALATE; OXYBENZONE .75; .04; 2 g/g; g/g; g/g 14783-038_0c3c71b9-8f8d-4de9-8fe4-04a2cb405093 14783-038 HUMAN OTC DRUG LBel Paris Renovance Jour Octinoxate, Octocrylene, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3.75; 2.5; 1.5 g/50g; g/50g; g/50g 14783-039_35041b4f-d141-4cf0-91c9-829ff347fe90 14783-039 HUMAN OTC DRUG LBel Paris Regression Jour Avobenzone, Ensulizole, Octinoxate, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD AVOBENZONE; ENSULIZOLE; OCTINOXATE; OXYBENZONE .1; .05; .375; .1 g/5g; g/5g; g/5g; g/5g 14783-045_4922ce2e-1697-4239-a440-41c84aa55b30 14783-045 HUMAN OTC DRUG LBel Paris Regression Jour Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTISALATE; OXYBENZONE .375; .2; .2 g/5g; g/5g; g/5g 14783-049_35041b4f-d141-4cf0-91c9-829ff347fe90 14783-049 HUMAN OTC DRUG LBel Paris Regression Jour Avobenzone, Ensulizole, Octinoxate, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD AVOBENZONE; ENSULIZOLE; OCTINOXATE; OXYBENZONE 1; .5; 3.75; 1 g/50g; g/50g; g/50g; g/50g 14783-055_4922ce2e-1697-4239-a440-41c84aa55b30 14783-055 HUMAN OTC DRUG LBel Paris Regression Jour Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTISALATE; OXYBENZONE 3.75; 2; 2 g/50g; g/50g; g/50g 14783-056_1865a6da-ed21-4419-82a8-f94342252275 14783-056 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Claire 1-2-3 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 14783-057_1865a6da-ed21-4419-82a8-f94342252275 14783-057 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Claire 4 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 14783-058_1865a6da-ed21-4419-82a8-f94342252275 14783-058 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Medium 5 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 14783-059_1865a6da-ed21-4419-82a8-f94342252275 14783-059 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Medium 6 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 14783-060_1865a6da-ed21-4419-82a8-f94342252275 14783-060 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Medium 7 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 14783-061_1865a6da-ed21-4419-82a8-f94342252275 14783-061 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Obscure 8-9 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .062393; .049 g/g; g/g; g/g 14783-062_f9c27f44-9167-439a-a8bf-0280eabe477e 14783-062 HUMAN OTC DRUG LBel Supremacie Mains Ensulizole, Octinoxate, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 VENTURA INTERNATIONAL LTD., ENSULIZOLE; OCTINOXATE; OXYBENZONE .15; .38; .31 g/5mL; g/5mL; g/5mL 14783-072_f9c27f44-9167-439a-a8bf-0280eabe477e 14783-072 HUMAN OTC DRUG LBel Supremacie Mains Ensulizole, Octinoxate, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 VENTURA INTERNATIONAL LTD., ENSULIZOLE; OCTINOXATE; OXYBENZONE 3; 7.5; 6.2 g/100mL; g/100mL; g/100mL 14783-077_41fa1e15-8b5e-45d6-adde-1769e084fa3b 14783-077 HUMAN OTC DRUG LBel Clarifique Dermo Radiance Mains SPF 15 Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 VENTURA INTERNATIONAL LTD., OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 6 g/100g; g/100g; g/100g 14783-081_e332c9be-a94b-433d-a793-86454e82dcb1 14783-081 HUMAN OTC DRUG LBel Couleur Luxe Rouge Amplifier XP Octinoxate and Oxybenzone LIPSTICK TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .18; .0036 g/4g; g/4g 14783-083_84e83063-f93c-4935-a846-5bb9decb9ebe 14783-083 HUMAN OTC DRUG LBel Couleur Luxe Supreme XP Octinoxate, Oxybenzone, and Titanium Dioxide LIPSTICK TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .0392; .0188; .0376 g/4g; g/4g; g/4g 14783-085_8166e1da-a159-41d9-b097-3c64bbf5ad87 14783-085 HUMAN OTC DRUG LBel Supremacie Teint Octinoxate CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 VENTURA INTERNATIONAL LTD., OCTINOXATE 1.35 g/30g 14783-091_bd919d7b-baa6-4d7d-920a-9a2b3dc49249 14783-091 HUMAN OTC DRUG LBel Effet Parfit Titanium dioxide POWDER TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD TITANIUM DIOXIDE .55 g/11g 14783-093_5248e1b3-7ab6-45f9-8e92-91a4432d4c5d 14783-093 HUMAN OTC DRUG Supremacie NX Jour Ensulizole, Homosalate, Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20100104 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD ENSULIZOLE; HOMOSALATE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .00075; .001; .00375; .00225; .000585 g/5mL; g/5mL; g/5mL; g/5mL; g/5mL 14783-094_56625705-f317-4a80-9167-edcfacaf5d93 14783-094 HUMAN OTC DRUG LBEL UV DEFENSE 365 Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide LOTION/SHAMPOO TOPICAL 20110829 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. (San Juan, P.R) HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE .05; .07; .05; .04; .0624; .0388 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL 14783-095_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-095 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - MOKA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-096_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-096 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ROMANCE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-097_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-097 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ROSE NATURAL Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-098_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-098 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ROSE CLASIQUE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-099_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-099 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ROUGE INTENSE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-100_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-100 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - AMOUR Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-101_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-101 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - CHOCOLAT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-102_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-102 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ALMOND Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-103_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-103 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - MALVE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-104_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-104 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - MARRON GLACE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-105_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-105 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - TULIP Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-106_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-106 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - NUDE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-107_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-107 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - LILY BEIGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-108_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-108 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - MANDARINE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-109_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-109 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - VIN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-121_652ed997-a464-4c52-870e-28c8bf3e3083 14783-121 HUMAN OTC DRUG LBEL Divine Lip Gloss SPF 15 Octinoxate and Oxybenzone LOTION TOPICAL 20111114 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. (San Juan, P.R) OCTINOXATE; OXYBENZONE .075; .03 mL/mL; mL/mL 14783-140_36f6fbf5-166f-47a3-b864-60de558168e2 14783-140 HUMAN OTC DRUG EFFET PARFAIT natural finish moisturizing foundation SPF 25 Octinoxate and Titanium Dioxide LOTION TOPICAL 20100916 OTC MONOGRAPH NOT FINAL part352 VENTURA INTERNATIONAL LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 mL/mL; mL/mL 14783-150_36f6fbf5-166f-47a3-b864-60de558168e2 14783-150 HUMAN OTC DRUG EFFET PARFAIT natural finish moisturizing foundation SPF 25 Octinoxate and Titanium Dioxide LOTION TOPICAL 20100916 OTC MONOGRAPH NOT FINAL part352 VENTURA INTERNATIONAL LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 mL/mL; mL/mL 14783-160_36f6fbf5-166f-47a3-b864-60de558168e2 14783-160 HUMAN OTC DRUG EFFET PARFAIT natural finish moisturizing foundation SPF 25 Octinoxate and Titanium Dioxide LOTION TOPICAL 20100916 OTC MONOGRAPH NOT FINAL part352 VENTURA INTERNATIONAL LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 mL/mL; mL/mL 14783-170_36f6fbf5-166f-47a3-b864-60de558168e2 14783-170 HUMAN OTC DRUG EFFET PARFAIT natural finish moisturizing foundation SPF 25 Octinoxate and Titanium Dioxide LOTION TOPICAL 20100916 OTC MONOGRAPH NOT FINAL part352 VENTURA INTERNATIONAL LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 mL/mL; mL/mL 14783-200_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-200 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 1) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL 14783-201_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-201 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 2) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL 14783-202_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-202 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 3) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL 14783-203_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-203 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 4) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL 14783-204_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-204 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 5) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL 14783-205_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-205 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 6) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL 14783-206_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-206 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 7) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL 14783-207_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-207 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (OBSCURE 8) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL 14783-208_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-208 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (OBSCURE 9) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL 14783-226_759d0a35-ec8c-4afb-b9c6-fcf30f3499be 14783-226 HUMAN OTC DRUG LBEL Lip Moisturizer SPF 18 Octinoxate, Oxybenzone, and Titanium Dioxide LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .03; .08 g/g; g/g; g/g 14783-240_063e6e3a-0506-4d86-9401-d37160f2b53d 14783-240 HUMAN OTC DRUG LBEL EFFET PARFAIT OCTINOXATE and OXYBENZONE POWDER TOPICAL 20100816 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. (San Francisco, CA) OCTINOXATE; OXYBENZONE .075; .02 g/g; g/g 14783-241_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-241 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 1) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 14783-242_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-242 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 2) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 14783-243_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-243 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 3) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 14783-244_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-244 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 4) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 14783-245_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-245 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 5) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 14783-246_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-246 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 6) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 14783-247_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-247 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 7) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 14783-248_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-248 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 14783-249_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-249 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 9) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 14783-250_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-250 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 6A) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 14783-251_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-251 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 6B) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 14783-252_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-252 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8A) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 14783-253_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-253 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8B) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 14783-254_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-254 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8C) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 14783-255_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-255 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 10) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 14783-256_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-256 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (DORE 6) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL 14783-266_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-266 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 1) - BEIGE Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL 14783-267_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-267 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 2) - BEIGE Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL 14783-268_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-268 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 3) - BEIGE Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL 14783-269_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-269 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 4) - BEIGE Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL 14783-270_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-270 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 5) - BROWN Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL 14783-271_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-271 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 6) - BROWN Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL 14783-272_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-272 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 7) - BROWN Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL 14783-273_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-273 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (OBSCURE 8) - BROWN Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL 14783-274_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-274 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (OBSCURE 9) - BROWN Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL 14783-301_723f46da-0a2c-4f0b-94cb-503c5ef931bb 14783-301 HUMAN OTC DRUG LBEL PROTEGE EXPERT Octinoxate, Octisalate, Oxybenzone, and Titanium dioxide LOTION TOPICAL 20110419 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .075; .05; .06; .0234 g/mL; g/mL; g/mL; g/mL 14783-302_710facca-d47f-478c-8baf-37d7b5a80fa5 14783-302 HUMAN OTC DRUG Esika Silk Skin OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .02; .044 g/g; g/g 14783-304_addec3e3-ea22-46cd-b788-e88efd85c920 14783-304 HUMAN OTC DRUG LBEL PROTEGE EXPERT Ensulizole, Octinoxate, Octisalate, Oxybenzone, and Titanium dioxide LOTION TOPICAL 20110419 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. ENSULIZOLE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .03; .075; .05; .06; .039 g/mL; g/mL; g/mL; g/mL; g/mL 14783-305_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-305 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE CHAMPAGNE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-306_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-306 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - FUCSIA SPLENDIDE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-307_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-307 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE DAMOUR Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-308_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-308 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE FORMIDABLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-309_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-309 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - NATURAL PERSISTANT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-310_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-310 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - MIEL ECHANTER Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-311_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-311 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE PRODIGEUX Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-312_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-312 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - MARRON ILLIMITE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-313_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-313 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - CHOCOLAT MAJESTIC Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-314_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-314 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - CAFE SUCCES Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-315_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-315 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE GRANDOISE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-316_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-316 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE RUBI Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-317_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-317 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - SAUMON ESSENTIEL Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-318_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-318 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - BOURGOGNE VIF Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-319_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-319 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - VIOLET POURPRE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-320_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-320 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - CORAIL MAXIMUM Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-321_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-321 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ORANGE DELIRANT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-322_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-322 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE INTENSE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-323_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-323 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE FEMME Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-324_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-324 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - DORE CHOCOLAT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-325_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-325 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - MER DE ROSES Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-326_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-326 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE TENTATION Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-327_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-327 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE DELICAT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-328_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-328 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - FUCSIA DESIR Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-329_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-329 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE PROVOCATION Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-330_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-330 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - AMPLIFFIER AMANDIER Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-331_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-331 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - SOBRIETE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-332_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-332 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - FIANCEE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-333_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-333 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROMANCE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-334_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-334 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - CARMINE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-335_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-335 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - NOBLESSE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-336_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-336 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - MALBEC Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-337_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-337 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE FUCSIA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g 14783-400_da6ec481-b844-411c-a101-1b8eae6c6c1e 14783-400 HUMAN OTC DRUG LBEL Hydra Calme SPF 15 Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE .075; .04; .04 g/mL; g/mL; g/mL 14783-434_3cc7d79e-48a5-440a-a5e7-ca9048ee07f0 14783-434 HUMAN OTC DRUG LBEL Dermo Clarite Avobenzone, Ensulizole, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20111126 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .03; .05; .05; .06 g/mL; g/mL; g/mL; g/mL; g/mL 14783-435_4fe4cd9a-fdfc-45ae-90e3-17bfb4addb57 14783-435 HUMAN OTC DRUG LBEL DRY EFFECT 48 Aluminum Sesquichlorohydrate LIQUID TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Ventura International Ltd ALUMINUM SESQUICHLOROHYDRATE .18 g/mL 14783-436_a8f69d9d-7d56-49a6-8245-6000113f7471 14783-436 HUMAN OTC DRUG LBEL HOMME ANTIDANDRUFF Pyrithione Zinc SHAMPOO TOPICAL 20120120 OTC MONOGRAPH FINAL part358H Ventura International Ltd PYRITHIONE ZINC .00336 g/mL 14783-437_fb9bf5e9-4358-4323-a36d-979ab3f7bdf2 14783-437 HUMAN OTC DRUG LBEL DRY EFFECT 48 ALUMINUM CHLOROHYDRATE AEROSOL, SPRAY TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Ventura International Ltd ALUMINUM CHLOROHYDRATE .24 g/mL 14783-438_6017bc97-c212-4454-8d1c-06acd24ef425 14783-438 HUMAN OTC DRUG LBEL Effet Parfait maximum comfort and long-lasting foundation spf 10 Zinc Oxide LOTION TOPICAL 20120210 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. ZINC OXIDE .0157 g/mL 14783-441_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-441 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROSE NATURAL) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-442_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-442 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROJO VIF) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-443_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-443 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (MOKA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-444_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-444 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (MANDARINE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-445_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-445 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (CAPUCCINO) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-446_ca71761d-0b6d-491d-ae64-7f234b1d4428 14783-446 HUMAN OTC DRUG LBel EFFET PARFAIT TITANIUM DIOXIDE, OXYBENZONE, and OCTINOXATE POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .04; .03; .04425 g/g; g/g; g/g 14783-447_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-447 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (FUCHSIA INTENSE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-448_2b1b12cf-a540-4abd-b6dd-d284d725e067 14783-448 HUMAN OTC DRUG LBel EFFET PARFAIT Loose Extra-Fine Portable TITANIUM DIOXIDE, OXYBENZONE, and OCTINOXATE POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .03; .03; .035 g/g; g/g; g/g 14783-449_5aae0369-5563-45b6-a28f-1a8aa5429107 14783-449 HUMAN OTC DRUG ESIKA MEN MAXIMUM STRENGTH PYRITHIONE ZINC LIQUID TOPICAL 20120124 OTC MONOGRAPH FINAL part358H Ventura International Ltd PYRITHIONE ZINC .00528 g/mL 14783-450_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-450 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (FUCHSIA BRILLANCE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-451_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-451 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROSE BRILLANCE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-452_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-452 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROSE CLASSIQUE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-453_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-453 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (VIN) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-454_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-454 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROUGE BRILLANCE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-455_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-455 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROUGE INTENSE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-467_f55025ad-f9d9-423a-9f92-2013ea447c85 14783-467 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (PECHE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL 14783-468_f55025ad-f9d9-423a-9f92-2013ea447c85 14783-468 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (GRAPE LUMIERE) - MAGENTA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL 14783-469_f55025ad-f9d9-423a-9f92-2013ea447c85 14783-469 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (SWEET FRAMBOISE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL 14783-470_f55025ad-f9d9-423a-9f92-2013ea447c85 14783-470 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (DOUCE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL 14783-471_f55025ad-f9d9-423a-9f92-2013ea447c85 14783-471 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (VIN) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL 14783-472_f55025ad-f9d9-423a-9f92-2013ea447c85 14783-472 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (CARAMEL MELON) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL 14783-473_f55025ad-f9d9-423a-9f92-2013ea447c85 14783-473 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (GROSEILLE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL 14783-474_f55025ad-f9d9-423a-9f92-2013ea447c85 14783-474 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (VIN SENSUELLE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL 14783-550_43d6cd8f-8279-4775-953c-44fe3a6e0a11 14783-550 HUMAN OTC DRUG LBel Protege Expert Octinoxate, Octisalate, Octocrylene, Oxybenzone, and Titanium dioxide CREAM TOPICAL 20110419 OTC MONOGRAPH NOT FINAL part352 Ventura International, Limited OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .075; .04; .1; .06; .01 g/g; g/g; g/g; g/g; g/g 14783-600_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-600 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (CLAIRE 1) - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 14783-601_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-601 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (CLAIRE 2) - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 14783-602_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-602 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (CLAIRE 3) - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 14783-603_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-603 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (CLAIRE 4) - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 14783-604_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-604 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (MEDIUM 5) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 14783-605_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-605 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (MEDIUM 6) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 14783-606_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-606 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (MEDIUM 7) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 14783-607_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-607 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (OBSCURE 8) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 14783-608_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-608 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (OBSCURE 9) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g 14783-660_14e8f5a0-541f-4968-ab49-3717c35559f1 14783-660 HUMAN OTC DRUG LBEL Couler Luxe Supreme XP Rosace, Excentrique, Harmonie Octinoxate, Oxybenzone, and Titanium Dioxide LIPSTICK TOPICAL 20101126 OTC MONOGRAPH NOT FINAL part352 Ventura International, Limited OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .0098; .0047; .0094 g/g; g/g; g/g 14783-661_14e8f5a0-541f-4968-ab49-3717c35559f1 14783-661 HUMAN OTC DRUG LBEL Couler Luxe Supreme XP Sublime, Orange, Sobriete Octinoxate, Oxybenzone, and Titanium Dioxide LIPSTICK TOPICAL 20101126 OTC MONOGRAPH NOT FINAL part352 Ventura International, Limited OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .0098; .0047; .0094 g/g; g/g; g/g 14783-770_ca7ee1e2-06a6-42f4-8be5-a202b052082d 14783-770 HUMAN OTC DRUG LBEL Effet Parfait Mineral Natural Skin Effect Mouse Foundation OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20101126 OTC MONOGRAPH NOT FINAL part352 Ventura International, Limited OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .016 g/g; g/g; g/g 14783-870_2af27d1c-1484-46de-8b90-5507611fb806 14783-870 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROUGE GRANDIOSE) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-871_2af27d1c-1484-46de-8b90-5507611fb806 14783-871 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROUGE RUBI) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-872_2af27d1c-1484-46de-8b90-5507611fb806 14783-872 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (SOBRIETE) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-873_2af27d1c-1484-46de-8b90-5507611fb806 14783-873 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (MARRON ILIMITEE) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-874_2af27d1c-1484-46de-8b90-5507611fb806 14783-874 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (CORAL MAXIMUM) - ORANGE OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-875_2af27d1c-1484-46de-8b90-5507611fb806 14783-875 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROSE TENTATION) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-876_2af27d1c-1484-46de-8b90-5507611fb806 14783-876 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROSE CHAMPAGNE) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-877_2af27d1c-1484-46de-8b90-5507611fb806 14783-877 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROSE DAMOUR) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-878_2af27d1c-1484-46de-8b90-5507611fb806 14783-878 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROMANCE) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-879_2af27d1c-1484-46de-8b90-5507611fb806 14783-879 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (FUCSIA SPLENDIDE) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-880_e4b2e969-94ba-46b2-9b07-28df81dd2598 14783-880 HUMAN OTC DRUG LBEL Couleur Luxe Supreme Laque OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20101205 OTC MONOGRAPH NOT FINAL part352 Ventura International, Limited OCTINOXATE; OXYBENZONE .07; .03 mL/mL; mL/mL 14783-881_2af27d1c-1484-46de-8b90-5507611fb806 14783-881 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (FUCSIA DESIR) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-882_2af27d1c-1484-46de-8b90-5507611fb806 14783-882 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROUGE PROVOCATION) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-883_2af27d1c-1484-46de-8b90-5507611fb806 14783-883 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (CARMINE) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-884_2af27d1c-1484-46de-8b90-5507611fb806 14783-884 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (MALBEC) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-885_2af27d1c-1484-46de-8b90-5507611fb806 14783-885 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (SALMON ESSENTIAL) - ORANGE OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-886_40ed7e9d-1b75-4c23-a2be-fb6605c51469 14783-886 HUMAN OTC DRUG LBEL EFFET PARFAIT DUAL-USE COMPACT YOUTHFUL LOOKING SKIN SPF7 Titanium Dioxide POWDER TOPICAL 20130916 OTC MONOGRAPH FINAL part352 Ventura International LTD. TITANIUM DIOXIDE .05 g/g 14783-887_2af27d1c-1484-46de-8b90-5507611fb806 14783-887 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (BOURGOGNE VIF) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-888_2af27d1c-1484-46de-8b90-5507611fb806 14783-888 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (GENUINE ROUGE) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-889_2af27d1c-1484-46de-8b90-5507611fb806 14783-889 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (VIOLET VELVET) - PURPLE OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-890_2af27d1c-1484-46de-8b90-5507611fb806 14783-890 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (MYSTIC ROSE) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g 14783-891_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-891 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MOKA) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-892_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-892 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROMANCE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-893_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-893 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROSE NATURAL) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-894_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-894 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROSE CLASIQUE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-895_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-895 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROUGE INTENSE) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-896_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-896 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (AMOUR) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-897_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-897 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (CHOCOLAT) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-898_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-898 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ALMOND) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-899_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-899 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MALVE) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-900_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-900 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MARRON GLACE) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-901_bfa9d95a-48e7-45c6-ab23-b1f5d92147c3 14783-901 HUMAN OTC DRUG LBEL DEFENSE 365 DAILY PROTECTIVE SPF 50 Octinoxate, Titanium Dioxide, Homosalate, Octisalate, Oxybenzone, and Zinc Oxide LOTION TOPICAL 20141014 OTC MONOGRAPH FINAL part352 Ventura International LTD HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE .05; .07; .05; .04; .062; .039 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL 14783-902_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-902 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (TULIP) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-903_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-903 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (LILY BEIGE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-904_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-904 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MANDARINE) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-905_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-905 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (VIN) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-906_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-906 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (TEA ROSE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-907_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-907 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (FRENESIE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-908_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-908 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (RICHE PINK) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-909_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-909 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (RED EXTASSY) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-910_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-910 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (FUCSIA) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-911_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-911 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (SOLEIL) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-912_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-912 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (TERRE) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-913_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-913 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (CHERRY BLOSSOM) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-914_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-914 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (VIN AMANT) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-915_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-915 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE INTIME) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-940_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-940 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14783-990_c55866be-7df4-4214-b7c5-3cb3de98d9f2 14783-990 HUMAN OTC DRUG LBEL COULEUR LUXE ROUGE IRRESISTIBLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20101126 OTC MONOGRAPH NOT FINAL part352 Ventura International, Limited OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g 14785-8117_05dd8b85-f789-4953-b629-53bc9477bd1e 14785-8117 HUMAN OTC DRUG Cold and Hot Medicated Menthol PATCH TOPICAL 20080410 OTC MONOGRAPH NOT FINAL part348 Mentholatum China Pharmaceutical Co. Ltd. MENTHOL 50 mg/1 14785-8123_bb5aba25-6e5a-4c7e-a485-764e589b08b9 14785-8123 HUMAN OTC DRUG WellPatch Backache Pain Relief Menthol PATCH TOPICAL 20080118 OTC MONOGRAPH NOT FINAL part348 Mentholatum (China) Pharmaceuticals Co Ltd MENTHOL 50 mg/1 14785-8126_c4cd6323-320b-4a0b-af78-63be4cda23ba 14785-8126 HUMAN OTC DRUG WellPatch Capsaicin Pain Relief Capsaicin PATCH TOPICAL 20080228 OTC MONOGRAPH NOT FINAL part348 Mentholatum (China) Pharmaceuticals Co Ltd CAPSAICIN .25 mg/1 14789-300_bbacbb05-2e18-4cf9-b239-6addb60b7533 14789-300 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Injection, USP BENZTROPINE MESYLATE INJECTION PARENTERAL 20090729 ANDA ANDA090233 Nexus Pharmaceuticals Inc BENZTROPINE MESYLATE 1 mg/mL Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 14789-400_cf92b847-8b96-4c6e-834a-632771688db7 14789-400 HUMAN PRESCRIPTION DRUG Levetiracetam LEVETIRACETAM INJECTION, SOLUTION INTRAVENOUS 20100603 ANDA ANDA090813 Nexus Pharmaceuticals Inc LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 14789-500_941ed07d-61f2-4774-8ee6-eafc76c99c5f 14789-500 HUMAN PRESCRIPTION DRUG Tranexamic acid TRANEXAMIC ACID INJECTION, SOLUTION INTRAVENOUS 20120315 ANDA ANDA091596 Nexus Pharmaceuticals Inc TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 14961-001_f40c6930-aeed-46cb-955f-0813675163f8 14961-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20050101 UNAPPROVED MEDICAL GAS Haun Specialty Gases, Inc. OXYGEN 990 L/L 14961-003_f0b0bb4a-33a2-426f-983f-633c0ed69fa4 14961-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen LIQUID TOPICAL 20050101 UNAPPROVED MEDICAL GAS Haun Specialty Gases, Inc. NITROGEN 990 L/L 15014-145_1d157217-d307-423c-8f50-965b23881330 15014-145 HUMAN PRESCRIPTION DRUG Prodrin Isometheptene Mucate, Caffeine, and Acetaminophen TABLET ORAL 20100601 UNAPPROVED DRUG OTHER Gentex Pharma ACETAMINOPHEN; CAFFEINE; ISOMETHEPTENE MUCATE 325; 20; 65 mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 15014-185_7e3f1f48-49ea-48e6-93c9-7e7a8dedc4ae 15014-185 HUMAN PRESCRIPTION DRUG NuCort Hydrocortisone Acetate LOTION TOPICAL 20100816 UNAPPROVED DRUG OTHER Gentex Pharma HYDROCORTISONE ACETATE 20 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 15054-0060_b6a04de9-7836-4ccd-9c34-43ffd7ae403b 15054-0060 HUMAN PRESCRIPTION DRUG Somatuline Depot lanreotide acetate INJECTION SUBCUTANEOUS 20071114 NDA NDA022074 Ipsen Biopharmaceuticals, Inc. LANREOTIDE ACETATE 60 mg/.2mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 15054-0090_b6a04de9-7836-4ccd-9c34-43ffd7ae403b 15054-0090 HUMAN PRESCRIPTION DRUG Somatuline Depot lanreotide acetate INJECTION SUBCUTANEOUS 20071114 NDA NDA022074 Ipsen Biopharmaceuticals, Inc. LANREOTIDE ACETATE 90 mg/.3mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 15054-0120_b6a04de9-7836-4ccd-9c34-43ffd7ae403b 15054-0120 HUMAN PRESCRIPTION DRUG Somatuline Depot lanreotide acetate INJECTION SUBCUTANEOUS 20071114 NDA NDA022074 Ipsen Biopharmaceuticals, Inc. LANREOTIDE ACETATE 120 mg/.5mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 15054-0211_750f74a5-be48-4849-be5c-ebcb6bae3dd8 15054-0211 HUMAN PRESCRIPTION DRUG APOKYN APOMORPHINE HYDROCHLORIDE INJECTION SUBCUTANEOUS 20040702 NDA NDA021264 Tercica, Inc. APOMORPHINE HYDROCHLORIDE 30 mg/3mL Dopamine Agonists [MoA],Dopaminergic Agonist [EPC] 15054-0500_b088271b-ca9f-4cf6-95a0-3b7d693deba2 15054-0500 HUMAN PRESCRIPTION DRUG Dysport Botulinum Toxin Type A INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20091102 BLA BLA125274 Ipsen Biopharmaceuticals, Inc. BOTULINUM TOXIN TYPE A 500 U/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] 15054-0530_b088271b-ca9f-4cf6-95a0-3b7d693deba2 15054-0530 HUMAN PRESCRIPTION DRUG Dysport Botulinum Toxin Type A INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20091102 BLA BLA125274 Ipsen Biopharmaceuticals, Inc. BOTULINUM TOXIN TYPE A 300 U/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] 15054-1040_a1076834-612d-46e7-a4a0-6305efb59aa5 15054-1040 HUMAN PRESCRIPTION DRUG Increlex mecasermin INJECTION, SOLUTION SUBCUTANEOUS 20060103 NDA NDA021839 Ipsen Biopharmaceuticals, Inc. MECASERMIN 40 mg/4mL 15054-1060_aba47d1e-608d-49c9-803a-6f390721907e 15054-1060 HUMAN PRESCRIPTION DRUG Somatuline Depot lanreotide acetate INJECTION SUBCUTANEOUS 20071114 NDA NDA022074 Ipsen Biopharmaceuticals, Inc. LANREOTIDE ACETATE 60 mg/.2mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 15054-1090_aba47d1e-608d-49c9-803a-6f390721907e 15054-1090 HUMAN PRESCRIPTION DRUG Somatuline Depot lanreotide acetate INJECTION SUBCUTANEOUS 20071114 NDA NDA022074 Ipsen Biopharmaceuticals, Inc. LANREOTIDE ACETATE 90 mg/.3mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 15054-1120_aba47d1e-608d-49c9-803a-6f390721907e 15054-1120 HUMAN PRESCRIPTION DRUG Somatuline Depot lanreotide acetate INJECTION SUBCUTANEOUS 20071114 NDA NDA022074 Ipsen Biopharmaceuticals, Inc. LANREOTIDE ACETATE 120 mg/.5mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 15062-003_47a46b37-65b4-4699-a4fb-4bd8715619e5 15062-003 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091026 UNAPPROVED MEDICAL GAS Texas Welders Supply Company OXYGEN 996 mL/L 15071-604_807982a5-c00f-476e-a20e-3315826756ba 15071-604 HUMAN OTC DRUG Rash Relief Zinc Oxide Dimethicone SPRAY TOPICAL 20050621 OTC MONOGRAPH FINAL part347 Touchless Care Concepts LLC DIMETHICONE; ZINC OXIDE 20; 25 g/100g; g/100g 15071-652_129b5c74-29e9-4827-a58a-47b5a9cac8e8 15071-652 HUMAN OTC DRUG Rash Relief Silver Dimethicone Zinc Oxide LIQUID TOPICAL 20081101 OTC MONOGRAPH FINAL part347 Touchless Care Concepts LLC DIMETHICONE; ZINC OXIDE 20; 25 g/100g; g/100g 15071-672_24e155fd-dad7-4d37-a12d-0c18fc624481 15071-672 HUMAN OTC DRUG Rash Relief Antibacterial Bacitracin Dimethicone Zinc Oxide LIQUID TOPICAL 20060614 OTC MONOGRAPH FINAL part333B Touchless Care Concepts LLC BACITRACIN; DIMETHICONE; ZINC OXIDE 500; 20; 25 [iU]/g; g/100g; g/100g 15071-704_f678f128-0e58-49db-a47d-21ab8f8c74a3 15071-704 HUMAN OTC DRUG Rash Relief Clear Petrolatum Dimethicone LIQUID TOPICAL 20050621 OTC MONOGRAPH FINAL part347 Touchless Care Concepts LLC DIMETHICONE; PETROLATUM 20; 25 g/100g; g/100g 15071-804_2d4f02ce-0bf1-4f31-9eb8-ee649af17ec2 15071-804 HUMAN OTC DRUG Rash Relief Antifungal Miconazole LIQUID TOPICAL 20060614 OTC MONOGRAPH FINAL part333C Touchless Care Concepts LLC DIMETHICONE; MICONAZOLE NITRATE; ZINC OXIDE 10; 2; 10 g/100g; g/100g; g/100g 15127-000_4a435290-f288-4f91-b731-4c0a6d60950b 15127-000 HUMAN OTC DRUG Select Brand Sunscreen OCTINOXATE, OXYBENZONE LOTION TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 Select Brand Distributors OCTINOXATE; OXYBENZONE 7.5; 4.5 g/100g; g/100g 15127-001_a9280d60-1ebb-4a34-af95-e9a3b86715dd 15127-001 HUMAN OTC DRUG Select Brand Sport Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part352 Select Brand Distributors AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g 15127-002_b3b33a6e-ec28-4c64-ac57-da170dec6eb3 15127-002 HUMAN OTC DRUG Select Brand Burn Relief LIDOCAINE HCL GEL TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part348 Select Brand Distributors LIDOCAINE HYDROCHLORIDE .5 g/100g 15127-003_44e0a3f5-32be-4e8a-9cfd-a9d61ad89737 15127-003 HUMAN OTC DRUG Select Brand Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121120 OTC MONOGRAPH NOT FINAL part352 Select Brand Distributors AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 15127-004_821a79d3-9937-447d-aa4f-e08312760acd 15127-004 HUMAN OTC DRUG Select Brand Baby Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121120 OTC MONOGRAPH NOT FINAL part352 Select Brand Distributors AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 15127-005_4060203f-9a89-487d-b9ad-c80cf8053697 15127-005 HUMAN OTC DRUG Select Brand Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 Select Brand Distributors AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g 15127-006_4614cd61-d4b4-4df5-8ea4-3bd0514e7e55 15127-006 HUMAN OTC DRUG Select Brand Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 Select Brand Distributors AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g 15127-010_2016b153-92fd-4262-8c9c-8d35a946d540 15127-010 HUMAN OTC DRUG Womens Gentle Laxative Bisacodyl TABLET, COATED ORAL 20000901 OTC MONOGRAPH NOT FINAL part334 Stephen L. LaFrance Pharmacy, Inc. BISACODYL 5 mg/1 15127-018_0dfeef5c-3f92-41f7-926a-298c7eab9b79 15127-018 HUMAN OTC DRUG Allergy Medicine Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 15127-033_06c458fc-22de-623a-e054-00144ff88e88 15127-033 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, COATED ORAL 20100816 OTC MONOGRAPH FINAL part341 Select Brand ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 15127-042_0f3c6d9c-2054-42b3-820b-dd2d32e6fe3c 15127-042 HUMAN OTC DRUG Infants Gas Relief Drops simethicone EMULSION ORAL 20130202 OTC MONOGRAPH FINAL part332 Select Brand DIMETHICONE 20 mg/.3mL 15127-050_de21d786-f0cf-4a47-9cde-56884c2d50d3 15127-050 HUMAN OTC DRUG Allerfed Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20020722 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 15127-052_8b61c7ad-9a20-4342-8a03-eb65aebc035e 15127-052 HUMAN OTC DRUG Select Brand Povidone Iodine Povidone Iodine 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Select Brand Distributors POVIDONE-IODINE 100 mg/mL 15127-060_8395ce53-6a95-43ee-bc1a-f276ec61dfae 15127-060 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20090416 OTC MONOGRAPH NOT FINAL part334 Select Brand MINERAL OIL 15 mL/15mL 15127-069_e2645545-3f62-4ad7-8203-883cba3464b9 15127-069 HUMAN OTC DRUG Petrolatum White Petrolatum JELLY TOPICAL 20090313 OTC MONOGRAPH FINAL part347 Select Brand Distributors PETROLATUM 1 g/g 15127-072_714824cc-424c-4ce0-adc6-b16c80bbeec3 15127-072 HUMAN OTC DRUG Pain Reliever Acetaminophen TABLET ORAL 19900713 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN 325 mg/1 15127-081_7d82e237-71ee-4617-8d44-93b3469730a9 15127-081 HUMAN OTC DRUG Suphedrine PE Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 15127-082_fa24d90d-38d7-472b-8cad-1cc8e0318030 15127-082 HUMAN OTC DRUG Sinus and Allergy Chlorpheniramine Maleate and Phenylephrine HCl TABLET ORAL 20050615 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 15127-105_cbadd2ef-120f-4033-992f-458559a5f7bc 15127-105 HUMAN OTC DRUG Senna-Lax Sennosides TABLET ORAL 19950127 OTC MONOGRAPH NOT FINAL part334 Stephen L. LaFrance Pharmacy, Inc. SENNOSIDES A AND B 8.6 mg/1 15127-115_467c35ec-3063-4a34-a7f6-c9a6f8b392dd 15127-115 HUMAN OTC DRUG Select Brand Earwax Removal Drops CARBAMIDE PEROXIDE LIQUID TOPICAL 20141128 OTC MONOGRAPH FINAL part344 Stephen L. LaFrance Pharmacy, Inc. CARBAMIDE PEROXIDE 65 mg/mL 15127-122_55b503f2-08ae-4ea6-8c1e-b004420851b5 15127-122 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20050923 OTC MONOGRAPH FINAL part333B Stephen L. LaFrance Pharmacy, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 15127-127_2523c13a-2c29-4f2a-bfee-8b339e3ed307 15127-127 HUMAN OTC DRUG Hydrocortisone Maximum Strength with Aloe Hydrocortisone CREAM TOPICAL 20050923 OTC MONOGRAPH NOT FINAL part348 Stephen L. LaFrance Pharmacy, Inc. HYDROCORTISONE 1 g/100g 15127-128_10c764d2-5504-4be7-aef2-a9b1ccd927e0 15127-128 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone OINTMENT TOPICAL 20080513 OTC MONOGRAPH NOT FINAL part348 Stephen L. LaFrance Pharmacy, Inc. HYDROCORTISONE 1 g/100g 15127-129_6bf19556-aebc-4a05-bd55-0a59254e92dc 15127-129 HUMAN OTC DRUG Select Brand Mucus Relief Guaifenesin TABLET ORAL 20140926 OTC MONOGRAPH FINAL part341 Select Brand Distributors GUAIFENESIN 200 mg/1 15127-138_2c4c19d5-705e-4e5e-81bb-e1400cfad21d 15127-138 HUMAN OTC DRUG Select Brand Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20140926 UNAPPROVED DRUG OTHER Select Brand Distributors PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 15127-140_71f039cb-c4cc-4097-a7a6-461823e3a758 15127-140 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20060201 OTC MONOGRAPH NOT FINAL part348 Select Brand HYDROCORTISONE 1 g/100g 15127-151_c59fcb7a-6b60-4e85-a020-2c65b7ebe284 15127-151 HUMAN OTC DRUG Select Brand Coughtab 400 Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Select Brand Distributors GUAIFENESIN 400 mg/1 15127-157_ce268749-fcb6-4d84-85ad-50952d06c30c 15127-157 HUMAN OTC DRUG gas relief simethicone TABLET, CHEWABLE ORAL 20090202 OTC MONOGRAPH FINAL part332 Select Brand DIMETHICONE 125 mg/1 15127-170_77f0990c-df64-42f6-b291-889049944454 15127-170 HUMAN OTC DRUG Select Brand Mucus Relief DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Select Brand Distributors DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 15127-171_4ce95bba-0bd7-4ee0-96c2-9d9887ec445c 15127-171 HUMAN OTC DRUG Select Brand Mucus Relief PE Guaifenesin/phenylephrine TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 Select Brand Distributors GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 15127-178_7be77de0-d4f7-4e2b-8701-2bbb0356094b 15127-178 HUMAN OTC DRUG Laxative Bisacodyl TABLET ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 Stephen L. LaFrance Pharmacy, Inc. BISACODYL 5 mg/1 15127-184_06c458fc-231c-623a-e054-00144ff88e88 15127-184 HUMAN OTC DRUG Severe Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20120306 OTC MONOGRAPH FINAL part341 Select Brand ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 15127-207_f8dc6d0f-a563-4b9a-b373-53e490b06e87 15127-207 HUMAN OTC DRUG Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20090202 OTC MONOGRAPH FINAL part331 Select Brand CALCIUM CARBONATE 750 mg/1 15127-210_520d029a-5b8a-4bfe-9ef4-c7eb378cb4c2 15127-210 HUMAN OTC DRUG Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20081212 OTC MONOGRAPH FINAL part331 Select Brand CALCIUM CARBONATE 500 mg/1 15127-211_db8374db-0a7e-471f-8760-411a2da55d7b 15127-211 HUMAN OTC DRUG Antacid calcium carbonate TABLET, CHEWABLE ORAL 20081212 OTC MONOGRAPH FINAL part331 Select Brand CALCIUM CARBONATE 500 mg/1 15127-212_e80cf9bb-b8b9-46ce-b835-5d512d2b85b7 15127-212 HUMAN OTC DRUG Select Brand Antacid Assorted Berries Calcium carbonate TABLET, CHEWABLE ORAL 20081212 OTC MONOGRAPH FINAL part331 Select Brand CALCIUM CARBONATE 750 mg/1 15127-226_24687128-01fb-462e-b4a3-4c2ed68ac10c 15127-226 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19921121 OTC MONOGRAPH FINAL part340 Stephen L. LaFrance Pharmacy, Inc. CAFFEINE 200 mg/1 15127-228_5da46f23-0014-48a0-99c7-830e8093b5b3 15127-228 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ASPIRIN 81 mg/1 15127-241_0593811b-7ec7-439f-b2a4-786906c3c6e5 15127-241 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ASPIRIN 81 mg/1 15127-258_24d75b3f-53d6-43e1-a513-cd2b1d6318bc 15127-258 HUMAN OTC DRUG Nighttime Sleep Diphenhydramine HCl TABLET ORAL 19921225 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 15127-261_0f3e163f-29b3-4b5f-8827-781e15d50c58 15127-261 HUMAN OTC DRUG Anti-Itch Extra Strength diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20060410 OTC MONOGRAPH NOT FINAL part348 Stephen L. LaFrance Pharmacy, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; 1 mg/g; mg/g 15127-262_790c6e02-b21d-4435-895b-fb685f653d00 15127-262 HUMAN OTC DRUG Motion Sickness Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 Stephen L. LaFrance Pharmacy, Inc. DIMENHYDRINATE 50 mg/1 15127-268_60e6a2e6-338e-4e55-84cd-06fdbdad9ce3 15127-268 HUMAN OTC DRUG Cough and Cold Chlorpheniramine maleate and Dextromethorphan Hydrobromide TABLET ORAL 20030503 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 15127-283_397bff9d-c1d0-4b47-8654-8df31aec61c5 15127-283 HUMAN OTC DRUG Allergy Medicine Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 15127-288_1d7319da-d81a-4b2a-bdb2-f542d5b7795c 15127-288 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 19950912 OTC MONOGRAPH NOT FINAL part334 Stephen L. LaFrance Pharmacy, Inc. DOCUSATE SODIUM 100 mg/1 15127-291_dba3eb3e-3271-4f45-aa8d-cfde9ceb96a7 15127-291 HUMAN OTC DRUG Select Brand Anti-Nausea phosphorated carbohydrate SOLUTION ORAL 20080101 UNAPPROVED DRUG OTHER Select Brand Distributors PHOSPHORIC ACID; SUCROSE 21.5; 3.74 mg/5mL; g/5mL 15127-311_d2ecb04f-b572-40ef-8ca2-ec886c9c0b54 15127-311 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090115 OTC MONOGRAPH FINAL part358H Select Brand Distributors PYRITHIONE ZINC 1 kg/100L 15127-312_3ea64293-0e19-4302-acbd-8143b80799ab 15127-312 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. IBUPROFEN 200 mg/1 15127-314_dddcd44b-5da8-4e71-b6e4-4f34bf47b32e 15127-314 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090723 OTC MONOGRAPH NOT FINAL part356 Select Brand HYDROGEN PEROXIDE 2.65 mL/100mL 15127-316_bb8b47b5-2d16-4f98-8b9b-59a736f8c7fe 15127-316 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100313 ANDA ANDA078682 Select Brand Dist. IBUPROFEN 200 mg/1 15127-318_9bb93916-b2eb-4bdc-a2f1-850c051976d3 15127-318 HUMAN OTC DRUG Antispetic Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 19911209 OTC MONOGRAPH NOT FINAL part356 Select Brand Distributors EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 15127-325_586b90a2-3123-4488-8393-e20d62843f33 15127-325 HUMAN OTC DRUG Pain Reliever PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 15127-332_52cde4d1-9930-4d53-9c28-2dcc281867d2 15127-332 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Select Brand ACETAMINOPHEN 650 mg/1 15127-335_c7715781-6586-413c-8cb8-543e121aa56d 15127-335 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. IBUPROFEN 200 mg/1 15127-338_e887e062-0b65-4612-b0bf-ea04f01cdbdb 15127-338 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Select Brand LOPERAMIDE HYDROCHLORIDE 2 mg/1 15127-340_9d228d53-a9ff-4391-8395-77580924fc26 15127-340 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20120330 ANDA ANDA200536 Select Brand RANITIDINE HYDROCHLORIDE 150 mg/1 15127-370_14f9b3e4-d31d-4e20-a402-a2c84d11a3f1 15127-370 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20120213 ANDA ANDA090283 Select Brand FAMOTIDINE 10 mg/1 15127-385_147a2c8c-865a-40bd-ac24-641c8e4a9b5d 15127-385 HUMAN OTC DRUG Allergy Severe Acetaminophen and Diphenhydramine HCl TABLET ORAL 20050606 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 12.5 mg/1; mg/1 15127-448_75558741-560d-437b-ab7f-ce8e73eb7fa0 15127-448 HUMAN OTC DRUG Backache Relief Magnesium Salicylate TABLET, FILM COATED ORAL 19981107 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. MAGNESIUM SALICYLATE 580 mg/1 15127-452_6e4a05c3-0277-4e40-a943-b15d0a549620 15127-452 HUMAN OTC DRUG Blue Ice Analgesic Gel Menthol GEL TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part348 Select Brand Distributors MENTHOL 2 g/100g 15127-470_6a440624-588f-492b-8fa9-28e169816ae3 15127-470 HUMAN OTC DRUG Select Brand Tab Tussin Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Select Brand Distributors GUAIFENESIN 400 mg/1 15127-471_da4e21a7-1939-4de2-9b07-d76f81899410 15127-471 HUMAN OTC DRUG Select Brand Tab Tussin DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Select Brand Distributors DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 15127-540_66952493-88ac-4260-a588-313dcf38b6a8 15127-540 HUMAN OTC DRUG Antacid Mint Aluminum Hydroxide, Magnesium Hydroxide and Dimethicone SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part331 Select Brand ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 15127-549_0c7fdea9-6f7d-4177-83c6-61fe85d8e20f 15127-549 HUMAN OTC DRUG Laxative Pills Sennosides PILL ORAL 20081212 OTC MONOGRAPH NOT FINAL part334 Select Brand SENNOSIDES 25 mg/1 15127-550_1cbb0df8-957d-4d40-8f24-32a108f09de4 15127-550 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20091103 OTC MONOGRAPH FINAL part335 Select Brand BISMUTH SUBSALICYLATE 262 mg/15mL 15127-550_cc57b24f-7aaa-4fb6-93c1-5d7c8da00d71 15127-550 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part335 Select Brand BISMUTH SUBSALICYLATE 262 mg/15mL 15127-551_c2109b1d-7763-4398-bf0e-63539ed9f7c6 15127-551 HUMAN OTC DRUG Peptic Relief Cherry Bismuth Subsalicylate SUSPENSION ORAL 20091103 OTC MONOGRAPH FINAL part335 Select Brand BISMUTH SUBSALICYLATE 262 mg/15mL 15127-555_92adee32-482f-46d5-b033-3c1874b73dfb 15127-555 HUMAN OTC DRUG Peptic Relief Maximum Strength BISMUTH SUBSALICYLATE SUSPENSION ORAL 20091103 OTC MONOGRAPH FINAL part341 Select Brand BISMUTH SUBSALICYLATE 525 mg/15mL 15127-590_1bd027ec-dae0-4e3e-b7df-d96280136d82 15127-590 HUMAN OTC DRUG Select Brand Hemorrhoid Glycerin, Petrolatum, Phenylephrine Hydrochloride, Pramoxine Hydrochloride CREAM RECTAL 20140301 OTC MONOGRAPH FINAL part346 Stephen L. LaFrance Pharmacy, Inc. GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 144; 150; 2.5; 10 mg/g; mg/g; mg/g; mg/g 15127-594_75b1127d-e75e-4ed8-aacb-661bc0e7813e 15127-594 HUMAN OTC DRUG Rest Simply Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 Stephen L. LaFrance Pharmacy, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 15127-595_cfa4ce6e-9d73-4822-bed2-48e3e2cbc95e 15127-595 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140430 OTC MONOGRAPH FINAL part338 Select Brand Dist. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 15127-598_4dee5516-70f1-464f-aa5a-d2feb41414eb 15127-598 HUMAN OTC DRUG Select Brand Hemorrhoid witch hazel CLOTH TOPICAL 20140905 OTC MONOGRAPH FINAL part346 Stephen L. LaFrance Pharmacy, Inc. WITCH HAZEL 500 mg/L 15127-686_73ce642d-663a-45e6-8cea-919729e177b5 15127-686 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20110310 OTC MONOGRAPH FINAL part334 Select Brand Distributors MAGNESIUM CITRATE 1.745 g/29.6mL 15127-693_27bcebc4-26df-41d6-bfc6-0ff9d87f3741 15127-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19931004 OTC MONOGRAPH NOT FINAL part334 Select Brands distributors MAGNESIUM CITRATE 1.745 g/29.6mL 15127-702_aff452f8-c436-4935-9718-5989d8ac734a 15127-702 HUMAN OTC DRUG Sore Throat Cherry Phenol LIQUID ORAL 20090617 OTC MONOGRAPH NOT FINAL part356 Select Brand PHENOL 1.5 g/100mL 15127-711_2b36b3a0-e2a7-4db3-ba87-965e7c8f3086 15127-711 HUMAN OTC DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20120710 ANDA ANDA201745 Select Brand RANITIDINE HYDROCHLORIDE 75 mg/1 15127-715_73e2a4b3-c024-4b6a-8a92-519df6c3f202 15127-715 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Select Brand LORATADINE 10 mg/1 15127-717_22389ba2-a1fe-4ea1-98a0-b08aa4179eb0 15127-717 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Select Brand LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 15127-730_c23ca6ac-5d5c-410d-a906-0cf3e80a623b 15127-730 HUMAN OTC DRUG Extra Strength Non-Aspirin Pain Reliever Acetaminophen TABLET ORAL 19930121 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN 500 mg/1 15127-735_99100182-4ae3-4a7d-a269-4f6941e8e558 15127-735 HUMAN OTC DRUG Pain Reliever Acetaminophen TABLET ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN 500 mg/1 15127-738_a3824705-83d5-47c3-819c-d7006d9e6742 15127-738 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19960210 OTC MONOGRAPH FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ASPIRIN 325 mg/1 15127-745_225dc288-a2e2-4299-bc91-41683914543b 15127-745 HUMAN OTC DRUG Antacid Antigas Maximum Strength ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE SUSPENSION ORAL 20091103 OTC MONOGRAPH FINAL part331 Select Brand ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 15127-804_17f13806-8ff5-42cb-ae59-56761d170d3d 15127-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20110310 OTC MONOGRAPH NOT FINAL part333A Select Brand Distributors ISOPROPYL ALCOHOL .91 mg/mL 15127-821_b833196a-3003-4a9e-ab5b-121bfa65aae9 15127-821 HUMAN OTC DRUG Chlorpheniramine Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 15127-822_5c4f0f69-4f8a-40f2-a249-cb8fc2f563c5 15127-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 20110310 OTC MONOGRAPH FINAL part346 Select Brands WITCH HAZEL 86 kg/100L 15127-831_8d913126-f054-4028-aafb-303e53696a38 15127-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 19931025 OTC MONOGRAPH NOT FINAL part334 Select Brand MINERAL OIL 999 mg/mL 15127-833_936eda8f-fd12-4320-9033-a9b698d73257 15127-833 HUMAN OTC DRUG Milk of Magnesia Original MAGNESIUM HYDROXIDE SUSPENSION ORAL 20091103 OTC MONOGRAPH FINAL part334 Select Brand MAGNESIUM HYDROXIDE 1200 mg/15mL 15127-833_a8e73b7c-cd0f-4e23-bdc3-210d4520d70c 15127-833 HUMAN OTC DRUG Milk of Magnesia Original MAGNESIUM HYDROXIDE SUSPENSION ORAL 20091103 OTC MONOGRAPH FINAL part334 Select Brand MAGNESIUM HYDROXIDE 1200 mg/15mL 15127-835_bf229f23-de94-4205-a483-8707ab72ed52 15127-835 HUMAN OTC DRUG Milk of Magnesia Mint Magnesium Hydroxide SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part334 Select Brand MAGNESIUM HYDROXIDE 1200 mg/15mL 15127-835_cfd29d52-2541-45db-8ee5-15670b676663 15127-835 HUMAN OTC DRUG Milk of Magnesia Mint Magnesium Hydroxide SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part334 Select Brand MAGNESIUM HYDROXIDE 1200 mg/15mL 15127-857_b56810f5-8408-49d4-8f1c-c1a75c1f8279 15127-857 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 15127-863_ac73f151-f30e-429b-bcdc-8965d6586cab 15127-863 HUMAN OTC DRUG Childrens Allergy Diphenhydramine HCl TABLET, CHEWABLE ORAL 20090320 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 15127-872_6f4739fd-b57b-4279-8406-363b44eaad9f 15127-872 HUMAN OTC DRUG Smooth texture Orange flavor psyllium husk POWDER, FOR SUSPENSION ORAL 20100404 OTC MONOGRAPH NOT FINAL part334 Select Brand PSYLLIUM HUSK 3.4 g/12g 15127-874_2401c474-5f82-40b8-83e6-0146c1f6ee0b 15127-874 HUMAN OTC DRUG Adult Low Strength Aspirin Aspirin TABLET, COATED ORAL 20040114 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ASPIRIN 81 mg/1 15127-877_f1d3e036-e75e-46f1-8cdb-4536fbbe005a 15127-877 HUMAN OTC DRUG Junior Strength Pain Reliever Grape Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN 160 mg/1 15127-883_ce8398a2-e38f-4554-896c-650887a1f0e3 15127-883 HUMAN OTC DRUG Antacid Antigas Aluminum Hydroxide, Magnesium Hydroxide and Dimethicone SUSPENSION ORAL 20091103 OTC MONOGRAPH FINAL part331 Select Brand ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 15127-887_a99543b6-4cdb-4924-9351-49115f97c3bc 15127-887 HUMAN OTC DRUG Select Brand Calaclear Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Select Brand Distributors ZINC OXIDE 160 mg/mL 15127-891_48aaca7b-966f-4b1c-81ce-18adcdacfa21 15127-891 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen LIQUID ORAL 20091002 ANDA ANDA079058 Stephen L. LaFrance Pharmacy, Inc. IBUPROFEN 50 mg/1.25mL 15127-895_7ea387db-e8b3-4f95-a4a7-63da572713b8 15127-895 HUMAN OTC DRUG Mucus Relief D Guaifenesin, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20070126 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 400; 40 mg/1; mg/1 15127-898_6c6ef5ea-a49f-466a-a9f8-a383c1d530bb 15127-898 HUMAN OTC DRUG Pain Reliever Extra Strength PM Acetaminophen, Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 15127-900_5c9eb2bf-e398-4b25-8469-534edf43ab68 15127-900 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20080213 ANDA ANDA074916 Stephen L. LaFrance Pharmacy, Inc. IBUPROFEN 100 mg/5mL 15127-901_d214af63-2c58-4ba3-95dd-aaacd7e34e72 15127-901 HUMAN OTC DRUG Cold and Flu Daytime Nighttime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine succinate KIT 20070919 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. 15127-905_e55aabf8-0b4d-44fe-bd15-0ba4a93d1296 15127-905 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20020330 ANDA ANDA075139 Stephen L. LaFrance Pharmacy, Inc. IBUPROFEN 200 mg/1 15127-907_1f4c4f1c-b551-47df-8118-6615886fda3e 15127-907 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20020408 ANDA ANDA075139 Stephen L. LaFrance Pharmacy, Inc. IBUPROFEN 200 mg/1 15127-909_f37b9fdc-9610-429f-bed4-d74893eda296 15127-909 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Select Brand CETIRIZINE HYDROCHLORIDE 10 mg/1 15127-919_7affe306-f012-402c-9e3c-0ddbbcef87a5 15127-919 HUMAN OTC DRUG Hydrocortisone Maximum Strength Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 20100405 OTC MONOGRAPH NOT FINAL part348 Stephen L. LaFrance Pharmacy, Inc. HYDROCORTISONE 1 g/100g 15127-925_abd39edb-ab95-4237-9a54-0818159a5bbe 15127-925 HUMAN OTC DRUG Cough Relief Orange Delsym LIQUID ORAL 20090921 OTC MONOGRAPH FINAL part341 Select Brand DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 15127-927_3ef02be2-b289-4c81-ae42-bcbc52032264 15127-927 HUMAN OTC DRUG Cold Multi-Symptom Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Chlorpheniramine maleate KIT ORAL 20050721 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. 15127-933_5d75d15e-fbf6-4742-b334-5e9d0f8a3f45 15127-933 HUMAN OTC DRUG Sinus Congestion and Pain Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20050715 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. 15127-938_3e26320d-ccc5-48d7-8b5b-8dbc7ce2f231 15127-938 HUMAN OTC DRUG Menstrual Relief Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 15127-940_4ac8d7ec-bbf1-4010-baf9-f5a169312bf8 15127-940 HUMAN OTC DRUG Tussin Original GUAIFENESIN LIQUID ORAL 20090617 OTC MONOGRAPH FINAL part341 Select Brand GUAIFENESIN 100 mg/5mL 15127-943_ea8759d5-b821-489e-9545-d97efc321886 15127-943 HUMAN OTC DRUG Tussin CF Robitussin CF LIQUID ORAL 20090821 OTC MONOGRAPH FINAL part341 Select Brand DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 15127-945_291c86a2-e79e-453f-ba43-fa1d30d3c416 15127-945 HUMAN OTC DRUG Tussin Original GUAIFENESIN LIQUID ORAL 20090714 OTC MONOGRAPH FINAL part341 Select Brand GUAIFENESIN 100 mg/5mL 15127-955_0c40d932-b31c-4da3-ae13-d9b6ae7c507f 15127-955 HUMAN OTC DRUG antacid Calcium carbonate TABLET, CHEWABLE ORAL 20081212 OTC MONOGRAPH FINAL part331 Select Brand CALCIUM CARBONATE 1000 mg/1 15127-957_e0d094d3-b5d3-49ec-84ef-ad3b2fe2253c 15127-957 HUMAN OTC DRUG Cold and Flu BP Acetaminophen and Chlorpheniramine Maleate TABLET, COATED ORAL 20050531 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 325; 2 mg/1; mg/1 15127-958_f760ab1a-36b9-4e78-a6a0-7735f5f852d8 15127-958 HUMAN OTC DRUG Maximum Strength Flu BP Acetaminophen, Chlorpheniramine maleate and Dextromethorphan HBr TABLET, FILM COATED ORAL 20050601 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 500; 2; 15 mg/1; mg/1; mg/1 15127-961_b6c9f447-8550-4239-a00a-8f98101d3542 15127-961 HUMAN OTC DRUG Maximum Strength Pseudoephedrine Pseudoephedrine HCl TABLET ORAL 19810825 20150913 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 15127-962_f041faee-c2f2-467e-9bed-43d1118f3510 15127-962 HUMAN OTC DRUG Cold Multi-Symptom Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Guaifenesin TABLET, FILM COATED ORAL 20060622 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 15127-963_b102ac9f-bb79-4e88-a921-daa09b05e782 15127-963 HUMAN OTC DRUG Sinus Congestion and Pain Severe Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, COATED ORAL 20050806 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 15127-964_2a4a5631-12b5-47b4-b1b6-958f3b4d627f 15127-964 HUMAN OTC DRUG Cold Head Congestion Severe Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Guaifenesin TABLET, FILM COATED ORAL 20060622 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 15127-965_765f3a57-3fda-4f69-9f5f-cb1ccfa5a826 15127-965 HUMAN OTC DRUG Sinus Congestion and Pain Acetaminophen and Phenylephrine HCl TABLET ORAL 20050726 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 15127-966_53b0c954-a7fd-44c0-8d41-31ad9e2f094a 15127-966 HUMAN OTC DRUG Sinus Congestion and Pain Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20050628 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 15127-968_38d13846-3bb0-4e2b-ad24-052cf9ddc4f1 15127-968 HUMAN OTC DRUG Pain Relief Fast Relief Aspirin, Citric Acid Monohydrate, and Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20061023 OTC MONOGRAPH FINAL part343 Select Brand ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 15127-972_014bf7f4-408c-4e0c-b601-614599bffa3f 15127-972 HUMAN OTC DRUG Extra Strength Non-Aspirin Pain Reliever Acetaminophen TABLET ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN 500 mg/1 15127-973_06c458fc-2307-623a-e054-00144ff88e88 15127-973 HUMAN OTC DRUG Allergy and Cold PE ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20081009 OTC MONOGRAPH FINAL part341 Select Brand ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 15127-974_06c458fc-22f2-623a-e054-00144ff88e88 15127-974 HUMAN OTC DRUG Severe Cold PE Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20080924 OTC MONOGRAPH FINAL part341 Select Brand ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 15127-978_5c9eb2bf-e398-4b25-8469-534edf43ab68 15127-978 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060525 ANDA ANDA074916 Stephen L. LaFrance Pharmacy, Inc. IBUPROFEN 100 mg/5mL 15127-979_a90cd258-ffa6-44e9-aaa0-04bdae94487e 15127-979 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Select Brand LORATADINE 10 mg/1 15127-980_3fbf1487-2d52-49b6-a6e8-a38ad2cf151c 15127-980 HUMAN OTC DRUG Night Time Original Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090714 OTC MONOGRAPH FINAL part341 Select Brand ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 15127-984_bf529a2b-db52-47c3-9662-dfcfe8cd704e 15127-984 HUMAN OTC DRUG Cough Control Dextromethorphan HBr CAPSULE, GELATIN COATED ORAL 20060424 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 15127-985_d587d1c5-800b-45e3-a04c-56286d437774 15127-985 HUMAN OTC DRUG Cold and Flu Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE ORAL 20070910 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 15127-989_43c0ffb6-4ede-47d3-8317-6f582186ce50 15127-989 HUMAN OTC DRUG Cold and Flu Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20070919 OTC MONOGRAPH FINAL part341 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 15127-994_f5ed24cd-c232-470c-bed4-7f6dc462e1c7 15127-994 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Stephen L. LaFrance Pharmacy, Inc. ACETAMINOPHEN 500 mg/1 15197-007_b6537332-c86e-4fec-8d8b-568f387277c4 15197-007 HUMAN OTC DRUG Bodyglide anti chafe balm Allantoin STICK TOPICAL 20091124 OTC MONOGRAPH FINAL part347 W STERNOFF LLC ALLANTOIN 5 mg/g 15197-008_7f61b268-213a-469d-9014-4cfcf1346779 15197-008 HUMAN OTC DRUG Chamois Glide Allantoin STICK TOPICAL 20091124 OTC MONOGRAPH FINAL part347 W STERNOFF LLC ALLANTOIN 5 mg/g 15197-009_6f13950d-4373-49f7-9faf-5de9ec64b0cf 15197-009 HUMAN OTC DRUG Bodyglide For Her Allantoin STICK TOPICAL 20091124 OTC MONOGRAPH FINAL part347 W STERNOFF LLC ALLANTOIN 5 mg/g 15231-100_add7f0ba-bb4c-4538-bedc-b1ab76c9199b 15231-100 HUMAN OTC DRUG ETHYL RUBBING ALCOHOL ALCOHOL LIQUID CUTANEOUS 19980209 OTC MONOGRAPH NOT FINAL part333E COMERCIALIZADORA JIQUILPAN S.A. DE C.V. ALCOHOL 70 mL/100mL 15240-0001_2861685a-0f67-4b70-9f58-bb7f4566c0aa 15240-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20051005 UNAPPROVED MEDICAL GAS Community Oxygen Services OXYGEN 99 L/100L 15304-4085_e80dad36-53a2-4d36-96b0-fd12192cd74b 15304-4085 HUMAN OTC DRUG Mastic Dent Sodium Fluoride, Eucalyptol, Thymol and Menthol MOUTHWASH DENTAL; ORAL 20051122 OTC MONOGRAPH NOT FINAL part356 Chia Gi LTD EUCALYPTOL; MENTHOL; SODIUM FLUORIDE; THYMOL .92; .42; .25; .64 mg/mL; mg/mL; mg/mL; mg/mL 15304-4182_3bf69e68-a5be-40b4-9f36-668ac750e0cd 15304-4182 HUMAN OTC DRUG Mastic Dent Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL; ORAL 20051122 OTC MONOGRAPH FINAL part355 Chia Gi LTD SODIUM FLUORIDE 2.2 mg/mL 15304-4681_ca4990dc-9be6-44e4-9a67-fb0eb0682b2f 15304-4681 HUMAN OTC DRUG Mastic Dent Oulo Action Sodium Fluoride PASTE, DENTIFRICE DENTAL; ORAL 20051122 OTC MONOGRAPH FINAL part355 Chia Gi LTD SODIUM FLUORIDE 2.2 mg/mL 15310-010_c716eae8-b9a9-4a5d-b153-79898f8ad9af 15310-010 HUMAN PRESCRIPTION DRUG EEMT ESTROGENS, ESTERIFIED and METHYLTESTOSTERONE TABLET, COATED ORAL 20110901 UNAPPROVED DRUG OTHER CREEKWOOD PHARMACEUTICAL, INC, ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE 1.25; 2.5 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 15310-020_c716eae8-b9a9-4a5d-b153-79898f8ad9af 15310-020 HUMAN PRESCRIPTION DRUG EEMT HS ESTROGENS, ESTERIFIED and METHYLTESTOSTERONE TABLET, COATED ORAL 20110901 UNAPPROVED DRUG OTHER CREEKWOOD PHARMACEUTICAL, INC, ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE .625; 1.25 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 15310-090_2cbb4414-0772-4557-af20-15f82268760f 15310-090 HUMAN OTC DRUG Pluratuss Brompheniramine Maleate, Codeine Phosphate, and Phenylephrine Hydrochloride LIQUID ORAL 20100106 OTC MONOGRAPH FINAL part341 Creekwood Pharmaceutical, Inc. BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10; 7.5 mg/5mL; mg/5mL; mg/5mL CV 15310-106_95627036-a0bc-469a-9e00-af6544f89a9d 15310-106 HUMAN OTC DRUG Dimetane DX Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide SYRUP ORAL 20110226 OTC MONOGRAPH FINAL part341 Creekwood Pharmaceuticals Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 10; 30 mg/5mL; mg/5mL; mg/5mL 15310-109_d2f3fd31-e4ed-485b-adb4-13f84f4dea43 15310-109 HUMAN PRESCRIPTION DRUG Carbinoxamine Maleate carbinoxamine maleate TABLET ORAL 20101027 ANDA ANDA040442 Creekwood Pharmaceuticals, Inc. CARBINOXAMINE MALEATE 4 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 15310-110_d2f3fd31-e4ed-485b-adb4-13f84f4dea43 15310-110 HUMAN PRESCRIPTION DRUG Carbinoxamine Maleate carbinoxamine maleate SYRUP ORAL 20101027 ANDA ANDA040458 Creekwood Pharmaceuticals, Inc. CARBINOXAMINE MALEATE 4 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 15338-100_b3fa8d62-cec4-416b-b979-56a945423ae1 15338-100 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19840507 ANDA ANDA062396 Apace Packaging LLC DOXYCYCLINE HYCLATE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 15338-122_8a9c319f-f300-3f89-5276-116410b86a26 15338-122 HUMAN PRESCRIPTION DRUG Klor-Con M10 Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20000809 ANDA ANDA074726 Apace Packaging LLC POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 15338-133_8a9c319f-f300-3f89-5276-116410b86a26 15338-133 HUMAN PRESCRIPTION DRUG Klor-Con M20 Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20000809 ANDA ANDA074726 Apace Packaging LLC POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 15338-150_31999703-3b31-4820-9319-1e5675c1ad82 15338-150 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20091206 NDA NDA070033 Apace Packaging METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 15338-170_3a1b39df-bc52-4ad7-87f6-ea77cac706f2 15338-170 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091223 NDA NDA080680 Apace Packaging FOLIC ACID 1 mg/1 15338-200_66234596-162c-4a33-b87e-635839655654 15338-200 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET, SOLUBLE ORAL 20090822 ANDA ANDA075843 Apace Packaging ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 15338-211_66234596-162c-4a33-b87e-635839655654 15338-211 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET, SOLUBLE ORAL 20090822 ANDA ANDA075843 Apace Packaging ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 15338-220_66234596-162c-4a33-b87e-635839655654 15338-220 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET, SOLUBLE ORAL 20090822 ANDA ANDA075843 Apace Packaging ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 15338-233_66234596-162c-4a33-b87e-635839655654 15338-233 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET, SOLUBLE ORAL 20090822 ANDA ANDA075843 Apace Packaging ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 15338-600_40c97a84-32b2-49cf-8c00-b2485b4e9d5f 15338-600 HUMAN PRESCRIPTION DRUG Belladonna Alkaloids with Phenobartbital Belladonna Alkaloids with Phenobartbital TABLET ORAL 20001201 UNAPPROVED DRUG OTHER Apace Packaging ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 15343-104_d577c12a-e6b8-4660-ada0-2b62cf8e852a 15343-104 HUMAN OTC DRUG Prime Asthma Relief Epinephrine KIT 20140821 OTC MONOGRAPH FINAL part341 DRNATURALHEALING 15343-105_d577c12a-e6b8-4660-ada0-2b62cf8e852a 15343-105 HUMAN OTC DRUG PRIME ASTHMA RELIEF EPINEPHRINE CAPSULE RESPIRATORY (INHALATION) 20140821 OTC MONOGRAPH FINAL part341 DRNATURALHEALING EPINEPHRINE .22 mg/1 15370-031_75f6366f-68a8-4273-83b3-bf072dee9c42 15370-031 HUMAN OTC DRUG RU-HIST-D Pyrilamine Maleate and Phenylephrine Hydrochloride TABLET ORAL 20081201 OTC MONOGRAPH FINAL part341 CARWIN ASSOCIATES, INC PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE 30; 30 mg/1; mg/1 15370-032_e79ed64d-daf5-4e30-bdf1-91d2031fc47e 15370-032 HUMAN OTC DRUG RU-HIST-D Pyrilamine Maleate and Phenylephrine Hydrochloride LIQUID ORAL 20120201 OTC MONOGRAPH FINAL part341 CARWIN ASSOCIATES, INC PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE 10; 30 mg/5mL; mg/5mL 15370-033_9b9cd110-c653-42b7-919e-ab9444c65a5a 15370-033 HUMAN OTC DRUG NU-COPD Guaifenesin and Phenylephrine Hydrochloride TABLET ORAL 20120415 OTC MONOGRAPH FINAL part341 CARWIN ASSOCIATES, INC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 15370-036_27c7dee6-c0bf-4668-b550-80450b84256b 15370-036 HUMAN OTC DRUG RU-HIST PLUS Pyrilamine Maleate, Phenylephrine Hydrochloride, and Dextromethorphan TABLET ORAL 20111201 OTC MONOGRAPH FINAL part341 CARWIN ASSOCIATES, INC DEXTROMETHORPHAN; PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE 20; 10; 30 mg/1; mg/1; mg/1 15370-100_66137662-03fc-4b10-aa0f-ab15f2a3981b 15370-100 HUMAN PRESCRIPTION DRUG Quflora Pediatric Drops VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE LIQUID ORAL 20140715 UNAPPROVED DRUG OTHER CarWin Pharmaceutical Associates, LLC .ALPHA.-TOCOPHEROL ACETATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; LEVOMEFOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A ACETATE 5; 35; 400; 1; 2; 35; 10; .8; .4; .6; .25; .5; 1000 [iU]/mL; mg/mL; [iU]/mL; mg/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 15370-101_a51f6842-3ae6-47c4-a3a5-7939e0de477a 15370-101 HUMAN PRESCRIPTION DRUG Quflora Pediatric Drops VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE LIQUID ORAL 20140715 UNAPPROVED DRUG OTHER CarWin Pharmaceutical Associates, LLC .ALPHA.-TOCOPHEROL ACETATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; LEVOMEFOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A ACETATE 12; 45; 400; 1; 3; 81; 12; 2; 1; 1; .5; 1; 1100 [iU]/mL; mg/mL; [iU]/mL; mg/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 15370-103_37e80a6d-913a-437f-8b00-6e9443702b33 15370-103 HUMAN PRESCRIPTION DRUG Quflora Pediatric VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20140106 UNAPPROVED DRUG OTHER CarWin Pharmaceutical Associates, LLC .ALPHA.-TOCOPHEROL, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FOLIC ACID; LEVOMEFOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A ACETATE 15; 60; 400; 1; 4; 100; 108; 15; 5; 1.5; 1.3; .25; 1.2; 1200 [iU]/1; mg/1; [iU]/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 15370-104_37e80a6d-913a-437f-8b00-6e9443702b33 15370-104 HUMAN PRESCRIPTION DRUG Quflora Pediatric VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20140106 UNAPPROVED DRUG OTHER CarWin Pharmaceutical Associates, LLC .ALPHA.-TOCOPHEROL, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FOLIC ACID; LEVOMEFOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A ACETATE 15; 60; 400; 1; 4; 100; 108; 15; 5; 1.5; 1.3; .5; 1.2; 1200 [iU]/1; mg/1; [iU]/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 15370-105_37e80a6d-913a-437f-8b00-6e9443702b33 15370-105 HUMAN PRESCRIPTION DRUG Quflora Pediatric VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20140106 UNAPPROVED DRUG OTHER CarWin Pharmaceutical Associates, LLC .ALPHA.-TOCOPHEROL, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FOLIC ACID; LEVOMEFOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A ACETATE 15; 60; 400; 1; 4; 100; 108; 15; 5; 1.5; 1.3; 1; 1.2; 1200 [iU]/1; mg/1; [iU]/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 15370-110_b1c39371-c657-41d7-9110-4af33245037a 15370-110 HUMAN OTC DRUG PediaVent DEXBROMPHENIRAMINE MALEATE SYRUP ORAL 20140804 OTC MONOGRAPH FINAL part341 CarWin Pharmaceutical Associates, LLC DEXBROMPHENIRAMINE MALEATE 2 mg/5mL 15370-112_ba4c3759-8540-4ccf-a18c-043eae719702 15370-112 HUMAN OTC DRUG PediaVent DEXBROMPHENIRAMINE MALEATE TABLET, CHEWABLE ORAL 20140805 OTC MONOGRAPH FINAL part341 CarWin Pharmaceutical Associates, LLC DEXBROMPHENIRAMINE MALEATE 1 mg/1 15377-002_9162ac36-62de-4d2c-bf16-c84045016264 15377-002 HUMAN OTC DRUG Neuragen PN Aconitum napellus, Hypericum perforatum, Lycopodium clavatum, Phosphorus, Rhus toxicodendron, Secale cornutum SOLUTION TOPICAL 20050801 UNAPPROVED HOMEOPATHIC Origin Biomed Inc ACONITUM NAPELLUS; CLAVICEPS PURPUREA SCLEROTIUM; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12; 12 [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL 15377-006_10554f30-db0e-4db4-a95a-936c40654e16 15377-006 HUMAN OTC DRUG Neuragen Pain Relief Hypericum, Aconitum Napellus, Lycopodium, Phosphorus, Rhus Toxicodendron GEL TOPICAL 20090501 UNAPPROVED HOMEOPATHIC Origin Biomed Inc ACONITUM NAPELLUS; CLAVICEPS PURPUREA SCLEROTIUM; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12; 12 [hp_C]/8g; [hp_C]/8g; [hp_C]/8g; [hp_C]/8g; [hp_C]/8g; [hp_C]/8g 15377-008_99127436-1f0a-4bca-8ed1-17707cd0efad 15377-008 HUMAN OTC DRUG Walgreens Nerve Pain Relief Aconitum Napellus, Hypericum Perforatum, Lycopodium clavatum, Phosphorus, Rhus Toxicodendron, Secale Cornutum SOLUTION TOPICAL 20100820 UNAPPROVED HOMEOPATHIC Origin Biomed Inc. ACONITUM NAPELLUS; CLAVICEPS PURPUREA SCLEROTIUM; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12; 12 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL 15377-010_9ba499c2-c23e-481d-9fa9-8862f043887a 15377-010 HUMAN OTC DRUG Neuragen Pain Relief Aconitum napellus, Hypericum perforatum, Lycopodium clavatum, Phosphorus, Rhus toxicodendron, Secale cornutum CREAM TOPICAL 20110801 UNAPPROVED HOMEOPATHIC Origin Biomed Inc. ACONITUM NAPELLUS; CLAVICEPS PURPUREA SCLEROTIUM; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12; 12 [hp_C]/113g; [hp_C]/113g; [hp_C]/113g; [hp_C]/113g; [hp_C]/113g; [hp_C]/113g 15377-012_db8c3872-fe84-46af-b155-9952d9154926 15377-012 HUMAN OTC DRUG Bionica Pain Relieving Gel Arnica, Belladonna, Bellis, Bryonia, Cuprum Acet, Cuprum Sulph, Calendula, Hypericum, Ledum, Rhus Tox, Ruta, Symphytum, Sulphuricum Ac, Calc Fluor, Calc Phos, Calch Sulph, Ferrum Phos, Kali Sulph, Mag Phos, Nat Mur, Nat Phos, Nat Sulphuricum GEL TOPICAL 20131003 UNAPPROVED HOMEOPATHIC Origin BioMed Inc. ARNICA MONTANA FLOWER; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; CUPRIC ACETATE; CUPRIC SULFATE; FERROSOFERRIC PHOSPHATE; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; SULFURIC ACID; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 12; 12; 6; 12; 12; 12; 12; 12; 30; 12; 30; 6; 6; 6; 30; 12; 6; 12; 6; 30; 10 [hp_C]/85g; [hp_C]/85g; [hp_C]/85g; [hp_C]/85g; [hp_C]/85g; [hp_X]/85g; [hp_C]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_C]/85g; [hp_C]/85g; [hp_C]/85g; [hp_C]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_C]/85g; [hp_X]/85g; [hp_X]/85g; [hp_C]/85g; [hp_X]/85g; [hp_C]/85g; [hp_X]/85g 15408-002_bf8375c1-c254-4451-9940-d38070bd4cdf 15408-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Westair Gas & Equipment, LLC NITROGEN 990 mL/L 15455-7566_09bcc196-2552-472a-e054-00144ff8d46c 15455-7566 HUMAN PRESCRIPTION DRUG Dipentocaine Topical Cream Compounding Kit Diclofenac Sodium, Gabapentin, and Lidocaine Hydrochloride KIT TOPICAL 20141106 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC 15478-001_be150a40-ab7f-4e93-ae01-888076d03d40 15478-001 HUMAN OTC DRUG Releev Cold Sore Treatment Benzalkonium Chloride LIQUID TOPICAL 20060601 OTC MONOGRAPH NOT FINAL part333A Topical Pharmaceuticals Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL 15478-003_1b161612-e50f-413f-a7e2-4764a6f9ad79 15478-003 HUMAN OTC DRUG Throat-Releev (Honey and Lemon) Benzalkonium Chloride LIQUID TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part333A Topical Pharmaceuticals Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL 15478-004_f2f8e83d-5bfe-4dc5-bf79-afd18965b833 15478-004 HUMAN OTC DRUG Throat-Releev (Cherry and Pomegranate) Benzalkonium Chloride LIQUID TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part333A Topical Pharmaceuticals Inc. BENZALKONIUM CHLORIDE 1.3 mL/mL 15478-005_20dbda91-9eaa-4045-8413-32db362f1644 15478-005 HUMAN OTC DRUG shing-Releev Benzalkonium Chloride LIQUID TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part333A Topical Pharmaceuticals Inc. ALLANTOIN; BENZALKONIUM CHLORIDE; BENZYL ALCOHOL 5; 1.3; 5 mL/mL; mL/mL; mL/mL 15499-1234_45708b10-03b2-4753-a1d1-45589d0bc628 15499-1234 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040401 UNAPPROVED MEDICAL GAS First Choice Medical Equipment Inc. OXYGEN 99 L/100L 15579-200_3bc5ac8f-1baa-4508-a1e9-19b2426f057c 15579-200 HUMAN OTC DRUG JET ALERT Double Strength Caffine TABLET, COATED ORAL 20141126 OTC MONOGRAPH FINAL part340 Bell Pharmaceuticals, Inc CAFFEINE 200 mg/1 15579-201_c1fae975-afa2-4e36-b8b3-6f49394b79ad 15579-201 HUMAN OTC DRUG JET ALERT Regular Strength Caffine TABLET, COATED ORAL 20141201 OTC MONOGRAPH FINAL part340 Bell Pharmaceuticals, Inc CAFFEINE 100 mg/1 15579-824_c020cad0-20d6-4f32-b49e-cebe58ef5a76 15579-824 HUMAN OTC DRUG jet-Alert Maximum Strength Alertness Aid Caffine CAPSULE, LIQUID FILLED ORAL 20141126 OTC MONOGRAPH FINAL part340 Bell Pharmaceuticals, Inc CAFFEINE 200 mg/1 15579-826_8d4a6a10-a017-45a2-b6ee-73a6e563a09c 15579-826 HUMAN OTC DRUG TRAV-L-TABS Meclizine Hydrochloride TABLET ORAL 20141201 OTC MONOGRAPH FINAL part336 Bell Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 15584-0101_4555b72a-75ae-4fb2-acf8-4be1fa2e5592 15584-0101 HUMAN PRESCRIPTION DRUG Atripla efavirenz, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20060720 NDA NDA021937 Bristol Myers Squibb & Gilead Sciences, LLC EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600; 200; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 15667-5049_a5157e03-c82f-4ce9-9355-6b1e5c078fe4 15667-5049 HUMAN OTC DRUG PAIN GOODBYE MEDICATED CREAM MENTHOL 5% CREAM TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part348 Austin Biotechnology Inc MENTHOL 14 g/280g 15667-7396_8c3ae600-4511-4868-a9bd-848f707e7f87 15667-7396 HUMAN OTC DRUG PAIN GOODBYE AQUEOUS PATCH METHYL SALICYLATE PATCH TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part348 Austin Biotechnology Inc 2-(L-MENTHOXY)ETHANOL; METHYL SALICYLATE 80; 50 mg/1000mg; mg/1000mg 15687-001_3df75c2e-c362-4a64-8769-9cc0e5adb01f 15687-001 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20050905 UNAPPROVED MEDICAL GAS Big Branch Breeders Service NITROGEN 990 mL/L 15749-801_da2a32ef-7ed4-4a3f-8e0d-326c91b191c6 15749-801 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110615 ANDA ANDA062713 American Antibiotics, Inc CEPHALEXIN 250 mg/1 15749-802_da2a32ef-7ed4-4a3f-8e0d-326c91b191c6 15749-802 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110615 ANDA ANDA062713 American Antibiotics, Inc CEPHALEXIN 500 mg/1 15749-820_60804b94-50f2-44c4-a6bf-871cab5af2f1 15749-820 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20110701 ANDA ANDA062058 American Antibiotics,Inc AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 15749-825_60804b94-50f2-44c4-a6bf-871cab5af2f1 15749-825 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20110701 ANDA ANDA062058 American Antibiotics,Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 15751-0252_0a4e46ab-eb64-4e5f-a0d3-99746726ad87 15751-0252 HUMAN OTC DRUG Tomato Day Broad Spectrum SPF 16 Sunscreen ZINC OXIDE CREAM TOPICAL 20120318 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care ZINC OXIDE 12 mL/100mL 15751-2222_02fb772a-06d6-4115-ae82-f43be2f0934e 15751-2222 HUMAN OTC DRUG Tropical Vanilla Body Sunscreen Broad Spectrum SPF 32 OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120323 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care OCTINOXATE; ZINC OXIDE 6; 5 mL/100mL; mL/100mL 15751-2223_0f03f2b7-0c6d-453f-8722-157b8cc27f58 15751-2223 HUMAN OTC DRUG Tropical Vanilla Sunscreen Broad Spectrum SPF 32 OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120307 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care OCTINOXATE; ZINC OXIDE 6; 5 mL/100mL; mL/100mL 15751-2235_3cb7abe8-a65e-4f51-a293-971bc89d8ead 15751-2235 HUMAN OTC DRUG Caramel Latte Tinted Moisturizer Broad Spectrum SPF 25 Sunscreen Light To Medium OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120317 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care OCTINOXATE; ZINC OXIDE 6; 6 mL/100mL; mL/100mL 15751-2236_5a911887-4a2c-4f37-b798-535ee01a2567 15751-2236 HUMAN OTC DRUG Cocoa Latte Tinted Moisturizer Broad Spectrum SPF 25 Sunscreen Medium To Dark OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120317 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care OCTINOXATE; ZINC OXIDE 6; 6 mL/100mL; mL/100mL 15751-2248_46834c06-0128-4164-857f-4359579dea99 15751-2248 HUMAN OTC DRUG Persimmon and Cantaloupe Day Sunscreen Broad Spectrum SPF 32 Oily to Normal OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120323 OTC MONOGRAPH FINAL part352 Eminence Organic Skin Care OCTINOXATE; ZINC OXIDE 6; 4.5 mL/100mL; mL/100mL 15751-2259_4f61c37d-430c-4a5b-8fa0-1ef89f07247a 15751-2259 HUMAN OTC DRUG Vanilla Latte Tinted Moisturizer Broad Spectrum SPF 25 Sunscreen Light OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120318 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care OCTINOXATE; ZINC OXIDE 6; 6 mL/100mL; mL/100mL 15751-2272_5dd1b2b4-0e0f-496c-839f-07534701a79c 15751-2272 HUMAN OTC DRUG EMINENCE Bright Skin Moisturizer BROAD SPECTRUM SPF 30 SUNSCREEN OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120726 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care OCTINOXATE; ZINC OXIDE 60; 45 mg/100mL; mg/100mL 15751-2286_e1bd9027-5eb4-4d49-a8a1-6df5c993cefc 15751-2286 HUMAN OTC DRUG EMINENCE Red Currant Protective Moisturizer OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20130822 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care OCTINOXATE; ZINC OXIDE 60; 45 mg/100mL; mg/100mL 15821-101_4d5a3f8a-3826-481e-b928-ff32deb2b593 15821-101 HUMAN OTC DRUG FreshKote Lubricant Eye Drops Povidone/Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20060401 OTC MONOGRAPH FINAL part349 FOCUS Laboratories, Inc. POLYVINYL ALCOHOL; POVIDONE K29/32 27; 20 g/1000mL; g/1000mL 15821-501_edbe40b6-28ac-4d78-95fb-c19225433c8a 15821-501 HUMAN PRESCRIPTION DRUG TOZAL Softgel CAPSULE, GELATIN COATED ORAL 20130601 UNAPPROVED DRUG OTHER FOCUS Laboratories, Inc. ALPHA-TOCOPHEROL; ASCORBIC ACID; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FOLIC ACID; LUTEIN; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; TAURINE; VITAMIN A PALMITATE; ZEAXANTHIN; ZINC PICOLINATE 200; 452; 1000; 1.6; 100; 1; 15; 600; 20; 400; 10000; 3; 40 [iU]/31; mg/31; [iU]/31; mg/31; ug/31; mg/31; mg/31; mg/31; mg/31; mg/31; [iU]/31; mg/31; mg/31 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] 15828-106_7100162b-2cc1-4a29-bfbf-9e56bd366480 15828-106 HUMAN OTC DRUG Invisible Splash Hair Minimizing Roll-On Antiperspirant ALUMINUM CHLORIDE LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part350 Zermat Internacional ALUMINUM CHLOROHYDRATE 20 mL/100mL 15828-205_bc386f6b-9239-4d2b-8942-60fc33654c69 15828-205 HUMAN OTC DRUG Zermat Invisible Splash Roll-On Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part350 Zermat Internacional ALUMINUM CHLOROHYDRATE 20 mL/100mL 15828-206_b70a899e-87d2-4c1e-8872-f5ad189c3f58 15828-206 HUMAN OTC DRUG Zermat Xtreme Roll-On Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20121018 OTC MONOGRAPH FINAL part350 Zermat Internacional S.A. de C.V. ALUMINUM CHLOROHYDRATE 8 g/100g 15828-207_6c1f1cd7-ee33-47e2-a05a-2d7603cf7fca 15828-207 HUMAN OTC DRUG Zermat Xtreme Roll-On Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130316 OTC MONOGRAPH FINAL part350 Zermat Internacional S.A. de C.V. ALUMINUM CHLOROHYDRATE 10 g/100g 15828-300_4aaa2e2c-ecdf-4bc8-a6ce-0ac99f423df5 15828-300 HUMAN OTC DRUG ZERMAT Sunscreen SPF 50 For Daily Use OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20130307 OTC MONOGRAPH NOT FINAL part352 Zermat Internacional S.A. de C.V. OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 2; 2; 2; 8.2 g/100g; g/100g; g/100g; g/100g; g/100g 15828-310_b411cea6-549f-497a-9516-8570e3d2e7ec 15828-310 HUMAN OTC DRUG zermat MAXIMUM REPAIR INTENSIVE FIRMING FACIAL DAY SUNSCREEN SPF 30 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20131120 OTC MONOGRAPH NOT FINAL part352 Zermat Internacional S.A. de C.V. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 3; .5 g/100g; g/100g; g/100g 15828-320_212c89af-7160-43d9-ac56-500afadde5a0 15828-320 HUMAN OTC DRUG zermat Wake Up CC Moisturizing Facial with Color Sunscreen Broad Spectrum SPF 30 OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Zermat Internacional S.A. de C.V. OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 2.5; 2.5; 2.5; 8 g/100g; g/100g; g/100g; g/100g 15828-400_eeb3b6bd-d5ef-49ae-870a-84d292993df5 15828-400 HUMAN OTC DRUG ZERMAT Sunscreen Broad Spectrum SPF 50 For Daily Use Non-Water Resistant OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part352 Zermat Internacional S.A. de C.V. OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 5; 10; 5; 8 g/100g; g/100g; g/100g; g/100g; g/100g 15828-870_011cb421-2bf3-415e-8a6e-54709b57826b 15828-870 HUMAN OTC DRUG zermat Antiperspirant Deodorant Roll-on for Men ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20131212 OTC MONOGRAPH FINAL part350 Zermat Internacional S.A. de C.V. ALUMINUM CHLOROHYDRATE 20 g/100g 15828-871_2926a557-724d-4ae2-848f-785ab3fbce3f 15828-871 HUMAN OTC DRUG zermat Antiperspirant Deodorant Roll-on for Women ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20131212 OTC MONOGRAPH FINAL part350 Zermat Internacional S.A. de C.V. ALUMINUM CHLOROHYDRATE 20 g/100g 15828-872_9f3b0ad4-db8e-4bed-8586-4a4c266cf68e 15828-872 HUMAN OTC DRUG zermat body breeze Roll-On Antiperspirant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20131224 OTC MONOGRAPH FINAL part350 Zermat Internacional S.A. de C.V. ALUMINUM CHLOROHYDRATE 20 g/100g 15828-880_8bee5c78-d1ca-4c91-904c-246ea4b9b4c3 15828-880 HUMAN OTC DRUG zermat Kiwi ANTIPERSPIRANT DEODORANT ROLL-ON SENSITIVE SKIN Aluminum chlorohydrate LIQUID TOPICAL 20131002 OTC MONOGRAPH FINAL part350 Zermat Internacional ALUMINUM CHLOROHYDRATE 10 g/100g 15828-881_2357030f-affb-4a48-9e28-114bec1348cf 15828-881 HUMAN OTC DRUG Zermat Kiwi with Fragrance Aluminum chlorohydrate LIQUID TOPICAL 20131002 OTC MONOGRAPH FINAL part350 Zermat Internacional ALUMINUM CHLOROHYDRATE 20 g/100g 15955-327_774a39b1-452c-4346-a77e-278f3b0b0db4 15955-327 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM SOLUTION ORAL 20120430 ANDA ANDA203067 Orit Laboratories LLC LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16038-001_fe4cc735-84dc-43d1-91de-239e5050f36e 16038-001 HUMAN OTC DRUG Saniquat Foaming hand sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100207 OTC MONOGRAPH NOT FINAL part333 West Penetone Inc BENZALKONIUM CHLORIDE .1 mL/100mL 16103-347_fb4fbd19-f19a-4dbd-a4e2-c1793bac5fa1 16103-347 HUMAN OTC DRUG Pharbedryl Diphenhydramine HCl CAPSULE ORAL 20061011 OTC MONOGRAPH FINAL part341 Pharbest Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 16103-348_a45391fb-267c-49ca-926b-8a3a2fad7480 16103-348 HUMAN OTC DRUG Pharbedryl Diphenhydramine HCl CAPSULE ORAL 20061011 OTC MONOGRAPH FINAL part341 Pharbest Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 16103-353_5426fd69-dc29-4b56-ae3a-bdab15e938ec 16103-353 HUMAN OTC DRUG Pharbetol Regular strength Acetaminophen TABLET ORAL 20070109 OTC MONOGRAPH NOT FINAL part343 Pharbest Pharmaceuticals, Inc. ACETAMINOPHEN 325 mg/1 16103-356_1a681eca-eaa3-49e6-9677-66824ae8561f 16103-356 HUMAN OTC DRUG Adult Low Dose Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20070112 OTC MONOGRAPH FINAL part343 Pharbest Pharmaceuticals, Inc. ASPIRIN 81 mg/1 16103-357_ab9291bb-f8a1-4e6a-8c67-4a7d004f8ba4 16103-357 HUMAN OTC DRUG Pharbest Aspirin 325mg Aspirin TABLET, DELAYED RELEASE ORAL 20100920 OTC MONOGRAPH FINAL part343 Pharbest Pharmaceuticals, Inc. ASPIRIN 325 mg/1 16103-363_e3ca2712-ae80-405d-b9e6-57ad99c13dd8 16103-363 HUMAN OTC DRUG Senna Tabs Senna TABLET, FILM COATED ORAL 20070124 OTC MONOGRAPH NOT FINAL part334 Pharbest Pharmaceuticals, Inc. SENNOSIDES A AND B 8.6 mg/1 16103-365_0c69cbcf-e43e-4f2a-a18b-db5c8ce04364 16103-365 HUMAN OTC DRUG Pharbest Regular Strength Aspirin Aspirin TABLET ORAL 20070112 OTC MONOGRAPH FINAL part343 Pharbest Pharmaceuticals, Inc ASPIRIN 325 mg/1 16103-366_ccb8eb4d-8e60-4a8c-a1c2-87bc3fca71a9 16103-366 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 20070822 OTC MONOGRAPH FINAL part343 Pharbest Pharmaceuticals, Inc. ASPIRIN 81 mg/1 16103-367_a86fbc38-1f71-4abc-aade-e98304763076 16103-367 HUMAN OTC DRUG Bisacodyl Bisacodyl TABLET, DELAYED RELEASE ORAL 20060125 OTC MONOGRAPH NOT FINAL part334 Pharbest Pharmaceuticals Inc. BISACODYL 5 mg/1 16103-376_27d87c86-7535-4032-8b57-c200dc5a503d 16103-376 HUMAN OTC DRUG Pharbetol Acetaminophen TABLET ORAL 20060110 OTC MONOGRAPH NOT FINAL part343 Pharbest Pharmaceuticals, Inc. ACETAMINOPHEN 500 mg/1 16103-377_af6b5439-4697-4120-b7d7-a613b8e06714 16103-377 HUMAN OTC DRUG Calcium Carbonate (Antacid) Calcium Carbonate TABLET ORAL 20061129 OTC MONOGRAPH FINAL part331 Pharbest Pharmaceuticals Inc. CALCIUM CARBONATE 648 mg/1 16103-384_53890faa-599b-4959-9eb4-f141abb61a1a 16103-384 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20070122 OTC MONOGRAPH NOT FINAL part334 Pharbest Pharmaceuticals, Inc. DOCUSATE SODIUM 100 mg/1 16103-393_b1099e02-e444-4d8a-97d7-1483202114b4 16103-393 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20110118 ANDA ANDA079129 Pharbest Pharmaceuticals, Inc. IBUPROFEN 200 mg/1 16110-026_becbd930-ea5f-11e3-ac10-0800200c9a66 16110-026 HUMAN PRESCRIPTION DRUG Cordran flurandrenolide OINTMENT TOPICAL 19651018 NDA NDA012806 Aqua Pharmaceuticals FLURANDRENOLIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16110-035_becbd930-ea5f-11e3-ac10-0800200c9a66 16110-035 HUMAN PRESCRIPTION DRUG Cordran flurandrenolide CREAM TOPICAL 19651018 NDA NDA012806 Aqua Pharmaceuticals FLURANDRENOLIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16110-052_fca8e801-018a-11e4-9191-0800200c9a66 16110-052 HUMAN PRESCRIPTION DRUG Cordran flurandrenolide LOTION TOPICAL 19630319 NDA NDA013790 Aqua Pharmaceuticals FLURANDRENOLIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16110-075_801944a0-d797-11e3-9c1a-0800200c9a66 16110-075 HUMAN PRESCRIPTION DRUG Monodox doxycycline CAPSULE ORAL 20070131 NDA NDA050641 Aqua Pharmaceuticals, LLC DOXYCYCLINE 75 mg/1 16110-080_a7348eef-8cf0-4cb6-a402-3bfd33feed75 16110-080 HUMAN PRESCRIPTION DRUG Xolegel ketoconazole GEL TOPICAL 20060728 NDA NDA021946 Aqua Pharmaceuticals, LLC. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 16110-111_64c13476-1af5-11e3-a19b-0800200c9a66 16110-111 HUMAN PRESCRIPTION DRUG Verdeso desonide AEROSOL, FOAM TOPICAL 20061006 NDA NDA021978 Aqua Pharmaceuticals DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16110-259_801944a0-d797-11e3-9c1a-0800200c9a66 16110-259 HUMAN PRESCRIPTION DRUG Monodox doxycycline CAPSULE ORAL 19891229 NDA NDA050641 Aqua Pharmaceuticals, LLC DOXYCYCLINE 100 mg/1 16110-260_801944a0-d797-11e3-9c1a-0800200c9a66 16110-260 HUMAN PRESCRIPTION DRUG Monodox doxycycline CAPSULE ORAL 19920210 NDA NDA050641 Aqua Pharmaceuticals, LLC DOXYCYCLINE 50 mg/1 16110-501_50efb530-1430-11e4-8c21-0800200c9a66 16110-501 HUMAN PRESCRIPTION DRUG Acticlate doxycycline hyclate TABLET, COATED ORAL 20140728 NDA NDA205931 Aqua Pharmaceuticals DOXYCYCLINE HYCLATE 75 mg/1 16110-502_50efb530-1430-11e4-8c21-0800200c9a66 16110-502 HUMAN PRESCRIPTION DRUG Acticlate doxycycline hyclate TABLET, COATED ORAL 20140728 NDA NDA205931 Aqua Pharmaceuticals DOXYCYCLINE HYCLATE 150 mg/1 16110-812_2262f565-8046-41b1-a62c-aac3ef2de03d 16110-812 HUMAN PRESCRIPTION DRUG Fluoroplex fluorouracil CREAM TOPICAL 19931203 NDA NDA016988 Aqua Pharmaceuticals, LLC FLUOROURACIL 10 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 16129-001_49fd0c9f-7aee-4244-a15e-33a389f26e3b 16129-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F-18 Fludeoxyglucose F-18 INJECTION INTRAVENOUS 20060329 ANDA ANDA204264 Shertech Laboratories, LLC FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 16129-002_028c5cf2-d763-4d0b-aa29-a903280137a2 16129-002 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F 18 INJECTION INTRAVENOUS 20110323 ANDA ANDA204315 Shertech Laboratories, LLC SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 16129-003_6bd4f4b7-b86e-45c3-a91f-4d434e8cced9 16129-003 HUMAN PRESCRIPTION DRUG Ammonia N 13 AMMONIA N-13 INJECTION INTRAVENOUS 20120612 ANDA ANDA204366 Shertech Laboratories, LLC AMMONIA N-13 260 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 16175-0001_d9fa4170-13e3-4807-a537-c9967fcfe715 16175-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20080819 UNAPPROVED MEDICAL GAS Calmar dba A&R Medical Supply OXYGEN 99 L/100L 16252-505_31bb288d-b017-554c-316b-dbbdee3a44e6 16252-505 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20061220 ANDA ANDA076685 Cobalt Laboratories Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16252-506_31bb288d-b017-554c-316b-dbbdee3a44e6 16252-506 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20061220 ANDA ANDA076685 Cobalt Laboratories Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16252-506_9039af24-f39c-1b00-d848-5dc4c9c59dc7 16252-506 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20061220 ANDA ANDA076685 Cobalt Laboratories Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16252-507_31bb288d-b017-554c-316b-dbbdee3a44e6 16252-507 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20061220 ANDA ANDA076685 Cobalt Laboratories Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16252-507_9039af24-f39c-1b00-d848-5dc4c9c59dc7 16252-507 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20061220 ANDA ANDA076685 Cobalt Laboratories Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16252-508_31bb288d-b017-554c-316b-dbbdee3a44e6 16252-508 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20061220 ANDA ANDA076685 Cobalt Laboratories Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16252-508_9039af24-f39c-1b00-d848-5dc4c9c59dc7 16252-508 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20061220 ANDA ANDA076685 Cobalt Laboratories Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16252-509_31bb288d-b017-554c-316b-dbbdee3a44e6 16252-509 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20061220 ANDA ANDA076685 Cobalt Laboratories Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16252-509_9039af24-f39c-1b00-d848-5dc4c9c59dc7 16252-509 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20061220 ANDA ANDA076685 Cobalt Laboratories Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16252-514_23fca3ed-ed03-407f-8127-7886b93a519a 16252-514 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 Actavis Pharma, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16252-515_23fca3ed-ed03-407f-8127-7886b93a519a 16252-515 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 Actavis Pharma, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16252-516_23fca3ed-ed03-407f-8127-7886b93a519a 16252-516 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 Actavis Pharma, Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16252-523_7dd7b873-6dd0-4ff4-958c-ae258bee88b3 16252-523 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20080507 ANDA ANDA077532 Cobalt Laboratories ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 16252-524_7dd7b873-6dd0-4ff4-958c-ae258bee88b3 16252-524 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20080507 ANDA ANDA077532 Cobalt Laboratories ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 16252-525_7dd7b873-6dd0-4ff4-958c-ae258bee88b3 16252-525 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20080507 ANDA ANDA077532 Cobalt Laboratories ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 16252-526_1cc1008f-9880-3257-7601-cc675037d7a2 16252-526 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA076939 Cobalt Laboratories Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16252-527_1cc1008f-9880-3257-7601-cc675037d7a2 16252-527 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA076939 Cobalt Laboratories Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16252-528_1cc1008f-9880-3257-7601-cc675037d7a2 16252-528 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA076939 Cobalt Laboratories Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16252-529_1cc1008f-9880-3257-7601-cc675037d7a2 16252-529 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20071228 ANDA ANDA076939 Cobalt Laboratories Inc. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16252-533_3cd9426a-7db9-6ec9-6881-b9df6def2ca7 16252-533 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077663 Cobalt Laboratories Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16252-534_3cd9426a-7db9-6ec9-6881-b9df6def2ca7 16252-534 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077663 Cobalt Laboratories Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16252-535_3cd9426a-7db9-6ec9-6881-b9df6def2ca7 16252-535 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077663 Cobalt Laboratories Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16252-536_2d5fd2ea-2490-46ef-bba8-60e1b2118788 16252-536 HUMAN PRESCRIPTION DRUG Cabergoline Cabergoline TABLET ORAL 20080421 ANDA ANDA078035 Cobalt Laboratories CABERGOLINE .5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 16252-539_d7a6d9ca-435e-4e51-a1c5-6609c6a9c63e 16252-539 HUMAN PRESCRIPTION DRUG Isradipine Isradipine CAPSULE ORAL 20040105 ANDA ANDA077317 Actavis Pharma, Inc. ISRADIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 16252-540_d7a6d9ca-435e-4e51-a1c5-6609c6a9c63e 16252-540 HUMAN PRESCRIPTION DRUG Isradipine Isradipine CAPSULE ORAL 20060105 ANDA ANDA077317 Actavis Pharma, Inc. ISRADIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 16252-541_c1c13b40-79dd-4e7b-a8f9-660b0212e680 16252-541 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070612 ANDA ANDA077805 Cobalt Laboratories TRANDOLAPRIL 1 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16252-542_c1c13b40-79dd-4e7b-a8f9-660b0212e680 16252-542 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070612 ANDA ANDA077805 Cobalt Laboratories TRANDOLAPRIL 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16252-543_c1c13b40-79dd-4e7b-a8f9-660b0212e680 16252-543 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070612 ANDA ANDA077805 Cobalt Laboratories TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16252-547_16638c0a-cf3c-479f-878a-168a00d584ed 16252-547 HUMAN PRESCRIPTION DRUG ipratropium bromide and albuterol sulfate ipratropium bromide and albuterol sulfate SOLUTION RESPIRATORY (INHALATION) 20071231 ANDA ANDA077063 Cobalt Laboratories ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 3; .5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 16252-558_3843fda0-28dd-37dc-532b-705db5239201 16252-558 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081205 ANDA ANDA077860 Cobalt Laboratories RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 16252-559_3843fda0-28dd-37dc-532b-705db5239201 16252-559 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081205 ANDA ANDA077860 Cobalt Laboratories RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 16252-560_3843fda0-28dd-37dc-532b-705db5239201 16252-560 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081205 ANDA ANDA077860 Cobalt Laboratories RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 16252-561_3843fda0-28dd-37dc-532b-705db5239201 16252-561 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081205 ANDA ANDA077860 Cobalt Laboratories RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 16252-562_3843fda0-28dd-37dc-532b-705db5239201 16252-562 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081205 ANDA ANDA077860 Cobalt Laboratories RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 16252-563_3843fda0-28dd-37dc-532b-705db5239201 16252-563 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081205 ANDA ANDA077860 Cobalt Laboratories RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 16252-568_a1b27593-53dd-4e77-8b44-2f7aaa15d7c8 16252-568 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, COATED PELLETS ORAL 20090415 ANDA ANDA077868 Cobalt Laboratories TOPIRAMATE 15 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16252-569_a1b27593-53dd-4e77-8b44-2f7aaa15d7c8 16252-569 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, COATED PELLETS ORAL 20090415 ANDA ANDA077868 Cobalt Laboratories TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16252-570_f9d26c5e-3482-4e3e-adf2-05f140ef6b47 16252-570 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20071226 ANDA ANDA076549 Cobalt Laboratories RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16252-571_f9d26c5e-3482-4e3e-adf2-05f140ef6b47 16252-571 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20071226 ANDA ANDA076549 Cobalt Laboratories RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16252-572_f9d26c5e-3482-4e3e-adf2-05f140ef6b47 16252-572 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20071226 ANDA ANDA076549 Cobalt Laboratories RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16252-573_f9d26c5e-3482-4e3e-adf2-05f140ef6b47 16252-573 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20071226 ANDA ANDA076549 Cobalt Laboratories RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16252-590_20e9bce7-bb6d-463c-bfcc-7596f3da1b2f 16252-590 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET ORAL 20090810 ANDA ANDA076933 Cobalt Laboratories SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 16252-591_20e9bce7-bb6d-463c-bfcc-7596f3da1b2f 16252-591 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET ORAL 20090810 ANDA ANDA076933 Cobalt Laboratories SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 16252-592_20e9bce7-bb6d-463c-bfcc-7596f3da1b2f 16252-592 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET ORAL 20090810 ANDA ANDA076933 Cobalt Laboratories SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 16252-597_2fdaecaf-e5e0-475c-a12e-b7a71527c456 16252-597 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET, CHEWABLE ORAL 20090729 ANDA ANDA076928 Cobalt Laboratories LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 16252-598_2fdaecaf-e5e0-475c-a12e-b7a71527c456 16252-598 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET, CHEWABLE ORAL 20090729 ANDA ANDA076928 Cobalt Laboratories LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 16252-599_c327c646-9fe5-4436-b252-788a0d6ebd73 16252-599 HUMAN PRESCRIPTION DRUG alendronate sodium alendronate sodium TABLET ORAL 20091023 ANDA ANDA076984 Cobalt Laboratories ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 16252-599_e8737423-2157-5d1d-90ec-bfe69e5796a9 16252-599 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20091023 ANDA ANDA076984 Cobalt Laboratories Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 16252-601_c327c646-9fe5-4436-b252-788a0d6ebd73 16252-601 HUMAN PRESCRIPTION DRUG alendronate sodium alendronate sodium TABLET ORAL 20080804 ANDA ANDA076984 Cobalt Laboratories ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 16252-601_e8737423-2157-5d1d-90ec-bfe69e5796a9 16252-601 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20080804 ANDA ANDA076984 Cobalt Laboratories Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 16408-2714_e7674795-329b-4f38-b0d4-7b3b82181a7a 16408-2714 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20051006 UNAPPROVED MEDICAL GAS Georgia Respiratory HomeCare & Medical Equipment LLC OXYGEN 99 L/100L 16477-106_80a6b82f-55e0-4545-ab7e-d26104897d48 16477-106 HUMAN OTC DRUG Donatussin DROPS Phenylephrine Hydrochloride, Guaifenesin LIQUID ORAL 20051220 OTC MONOGRAPH FINAL part341 Laser Pharmaceuticals, LLC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 1.5 mg/mL; mg/mL 16477-121_085cad65-ce26-4b6d-a74b-044f8757a77d 16477-121 HUMAN OTC DRUG Dallergy DROPS Chlorpheniramine Maleate, Phenylephrine Hydrochloride LIQUID ORAL 20140201 OTC MONOGRAPH FINAL part341 Laser Pharmaceuticals, LLC CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/mL; mg/mL 16477-136_9872d769-7d40-4f24-96ab-8d944073b185 16477-136 HUMAN PRESCRIPTION DRUG Donatuss DC Dihydrocodeine Bitartrate, Phenylephrine Hydrochloride, Guaifenesin SYRUP ORAL 20091007 UNAPPROVED OTHER Laser Pharmaceuticals LLC DIHYDROCODEINE BITARTRATE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 7.5; 50; 7.5 mg/5mL; mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] CIII 16477-152_1d3601d5-16e9-4845-afbd-b03af076e1f9 16477-152 HUMAN OTC DRUG Dallergy CHLORCYCLIZINE HYDROCHLORIDE TABLET, CHEWABLE ORAL 20111101 OTC MONOGRAPH FINAL part341 Laser Pharmaceuticals, LLC CHLORCYCLIZINE HYDROCHLORIDE; PHENYLEPHRINE 12.5; 5 mg/1; mg/1 16477-161_32874f2d-8e77-42f5-a878-b5c843bd669c 16477-161 HUMAN OTC DRUG Dallergy Dexbrompheniramine Maleate and Phenylephrine HCl TABLET ORAL 20140201 OTC MONOGRAPH FINAL part341 Laser Pharmaceuticals, LLC DEXBROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 5 mg/1; mg/1 16477-185_4451a110-89c8-4c99-9caa-39cc46178488 16477-185 HUMAN OTC DRUG Donatussin Chlophedianol Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride SYRUP ORAL 20110928 OTC MONOGRAPH FINAL part341 Laser Pharmaceuticals, LLC CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 12.5; 120; 5 mg/5mL; mg/5mL; mg/5mL 16477-186_55a61c5a-c3c3-417d-aa90-37b1c90955ab 16477-186 HUMAN OTC DRUG Donatussin Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride SYRUP ORAL 20140219 OTC MONOGRAPH FINAL part341 Laser Pharmaceuticals, LLC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 20; 10 mg/5mL; mg/5mL; mg/5mL 16477-306_a85a5622-5f5e-486e-9370-0cb738d82d11 16477-306 HUMAN OTC DRUG Respaire-30 GUAIFENESIN CAPSULE ORAL 20080902 OTC MONOGRAPH FINAL part341 Laser Pharmaceuticals, LLC GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 150; 30 mg/1; mg/1 16477-401_8854c60c-efaa-4e40-9bcf-bb6f40d9eda9 16477-401 HUMAN OTC DRUG Cyclivert CYCLIZINE HYDROCHLORIDE TABLET ORAL 20111101 OTC MONOGRAPH FINAL part336 Laser Pharmaceuticals, LLC CYCLIZINE HYDROCHLORIDE 25 mg/25mg 16477-505_0e6cab4b-a5ad-48ae-9a1a-3c4b28c13f13 16477-505 HUMAN PRESCRIPTION DRUG MILLIPRED PREDNISOLONE TABLET ORAL 20081001 ANDA ANDA080354 Laser Pharmaceuticals, LLC PREDNISOLONE 5 mg/5mg Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16477-510_3b7e7191-d822-4b0d-8285-73e344c0f3ba 16477-510 HUMAN PRESCRIPTION DRUG Millipred PREDNISOLONE SODIUM PHOSPHATE SOLUTION ORAL 20090701 ANDA ANDA078465 Laser Pharmaceuticals, LLC PREDNISOLONE SODIUM PHOSPHATE 10 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16477-562_00c14b73-da57-4d83-b5b1-61eae1f03939 16477-562 HUMAN OTC DRUG Neo DM Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, and Brompheniramine Maleate SYRUP ORAL 20080102 OTC MONOGRAPH FINAL part341 Laser Pharmaceuticals LLC BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 3; 30; 50 mg/5mL; mg/5mL; mg/5mL 16477-620_d3ff9b99-6ef2-4238-b7f8-f331ce038943 16477-620 HUMAN OTC DRUG Neo DM DROPS DM Dextromethophan Hydrobromide, Chlorpheniramine Maleate, Phenylephrine Hydrochloride LIQUID ORAL 20061006 OTC MONOGRAPH FINAL part341 Laser Pharmaceuticals, LLC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE .75; 2.75; 1.75 mg/mL; mg/mL; mg/mL 16477-628_c64000e6-951e-4a1f-8430-6f92b19c87d7 16477-628 HUMAN OTC DRUG Neo AC Codeine Phosphate, Pseudoephedrine Hydrochloride, Pyrilamine Maleate SYRUP ORAL 20090922 OTC MONOGRAPH FINAL part341 Laser Pharmaceuticals LLC CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; PYRILAMINE MALEATE 10; 30; 15 mg/5mL; mg/5mL; mg/5mL CV 16477-811_3c37375e-85f0-49d3-bf68-ef7eb5a9742e 16477-811 HUMAN OTC DRUG Donatussin DM Drops DM Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20051220 OTC MONOGRAPH FINAL part341 Laser Pharmaceuticals, LLC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 3; 1.5 mg/mL; mg/mL; mg/mL 16477-820_03e29ce8-14ac-4c97-bc61-9ab255fd7e98 16477-820 HUMAN OTC DRUG Dallergy Chlorcyclizine Hydrochloride, Phenylephrine Hydrochloride SYRUP ORAL 20111018 OTC MONOGRAPH FINAL part341 Laser Pharmaceuticals, LLC CHLORCYCLIZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 12.5; 5 mg/5mL; mg/5mL 16477-822_7701ea4c-ccf2-4384-b865-9075d9b1788c 16477-822 HUMAN OTC DRUG Dallergy Dexbrompheniramine Maleate, Phenylephrine Hydrochloride SYRUP ORAL 20140601 OTC MONOGRAPH FINAL part341 Laser Pharmaceuticals, LLC DEXBROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 5 mg/5mL; mg/5mL 16480-002_47216f1c-13d0-4335-989f-722ef717850c 16480-002 HUMAN OTC DRUG Chan Yat Hing She Kun Wool Lok Medicated Oil Camphor, Menthol, Turpentine Oil OIL TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part348 Chan Yat Hing Medicine Factory CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE; TURPENTINE OIL 9; 39; 5; 18 g/100mL; g/100mL; g/100mL; g/100mL 16496-544_0d3836dd-d37e-4078-ba92-38a18f314b70 16496-544 HUMAN OTC DRUG Antiseptic Hand CHLOROXYLENOL SOAP TOPICAL 20050930 OTC MONOGRAPH NOT FINAL part333E Image Supply, Inc. CHLOROXYLENOL 3 mg/mL 16555-006_0aa154f3-2406-468f-b650-1163e3111890 16555-006 HUMAN OTC DRUG VIALPROTECTION AGE DEFYING PROTECTIVE SPF 50 HOMOSALATE, OCTISALATE, AVOBENZONE OXYBENZONE LOTION TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 DARPHIN DIST. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 5; 5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL 16555-007_552e5a85-0e3d-427b-b178-0c554c037c91 16555-007 HUMAN OTC DRUG DARPHIN CC INSTANT MULTI-BENEFIT CARE BROAD SPECTRUM SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 DARPHIN DIST. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .08175; .0436; .02725; .01199 g/100mL; g/100mL; g/100mL; g/100mL 16555-996_3771b213-03f0-45e5-9423-bff016c95c56 16555-996 HUMAN OTC DRUG DENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20040801 OTC MONOGRAPH FINAL part355 DARPHIN DIST. SODIUM MONOFLUOROPHOSPHATE .76 mL/100mL 16571-011_d3c75f8e-7b30-4536-862a-74e773853575 16571-011 HUMAN PRESCRIPTION DRUG Theophylline(Anhydrous) Theophylline TABLET, EXTENDED RELEASE ORAL 20100915 ANDA ANDA040595 PACK Pharmaceuticals, LLC THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 16571-012_e6d3ddb1-784d-420c-a1ef-7f349cf6f55d 16571-012 HUMAN PRESCRIPTION DRUG Piroxicam piroxicam CAPSULE ORAL 20100615 ANDA ANDA074116 PACK Pharmaceuticals, LLC PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16571-013_e6d3ddb1-784d-420c-a1ef-7f349cf6f55d 16571-013 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20100615 ANDA ANDA074118 PACK Pharmaceuticals, LLC PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16571-070_309bc345-79d1-4e7a-80fc-cfafd8e1010b 16571-070 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor SUSPENSION ORAL 20121025 ANDA ANDA065412 Pack Pharmaceuticals, LLC CEFACLOR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16571-071_309bc345-79d1-4e7a-80fc-cfafd8e1010b 16571-071 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor SUSPENSION ORAL 20121031 ANDA ANDA065412 Pack Pharmaceuticals, LLC CEFACLOR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16571-072_309bc345-79d1-4e7a-80fc-cfafd8e1010b 16571-072 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor SUSPENSION ORAL 20121031 ANDA ANDA065412 Pack Pharmaceuticals, LLC CEFACLOR 375 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16571-101_9be925f2-01e7-4a26-bd65-3ab25492ebc4 16571-101 HUMAN PRESCRIPTION DRUG Diclofenac Sodium DICLOFENAC SODIUM SOLUTION/ DROPS OPHTHALMIC 20080620 ANDA ANDA078553 PACK Pharmaceuticals, LLC DICLOFENAC SODIUM 3.5 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16571-120_2a5f5eaf-175f-478e-87ba-cccb298b23c9 16571-120 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS TOPICAL 20080320 ANDA ANDA077689 PACK Pharmaceuticals, LLC CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16571-130_349789cb-da00-4eeb-88fa-a949263c1618 16571-130 HUMAN PRESCRIPTION DRUG ofloxacin ofloxacin SOLUTION OPHTHALMIC 20100104 ANDA ANDA078559 Pack Pharmaceuticals, LLC OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16571-135_45ff37cf-bb29-4e8b-99b4-881967ef61b3 16571-135 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20100915 ANDA ANDA077568 Pack Pharmaceuticals, LLC CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16571-140_32263a45-99ba-4ca0-a0cb-a9bbdf7792f5 16571-140 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20090216 ANDA ANDA077259 Pack Pharmaceuticals LLC TIMOLOL MALEATE 2.5 mg/mL 16571-141_8edf0a8c-5c33-4948-b91d-9ace251c9cae 16571-141 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20090216 ANDA ANDA077259 Pack Pharmaceuticals LLC TIMOLOL MALEATE 5 mg/mL 16571-150_c9ef1bfa-00ae-4847-9588-97215974bad8 16571-150 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN SOLUTION/ DROPS TOPICAL 20101220 ANDA ANDA077700 PACK Pharmaceuticals, LLC LEVOFLOXACIN 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16571-160_6eeb2f43-9d14-4f1e-a43d-d33abd826585 16571-160 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20101117 ANDA ANDA091630 Pack Pharmaceuticals, LLC TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 16571-161_6eeb2f43-9d14-4f1e-a43d-d33abd826585 16571-161 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20101117 ANDA ANDA091630 Pack Pharmaceuticals, LLC TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 16571-201_5f6a5b1b-970a-4e06-929b-32b91ff7b139 16571-201 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Pack Pharmaceuticals, LLC DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16571-202_c1da9291-8e59-4da1-b08d-b714cc29d5ed 16571-202 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20101231 ANDA ANDA090066 Pack Pharmaceuticals, LLC DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16571-203_c1da9291-8e59-4da1-b08d-b714cc29d5ed 16571-203 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20101231 ANDA ANDA090066 Pack Pharmaceuticals, LLC DICLOFENAC SODIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16571-210_aca0817a-62a1-4d46-a874-5b88c28dc167 16571-210 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140324 ANDA ANDA076957 Pack Pharmaceuticals, LLC FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 16571-211_aca0817a-62a1-4d46-a874-5b88c28dc167 16571-211 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140324 ANDA ANDA076957 Pack Pharmaceuticals, LLC FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 16571-213_aca0817a-62a1-4d46-a874-5b88c28dc167 16571-213 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140324 ANDA ANDA076957 Pack Pharmaceuticals, LLC FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 16571-214_3a66b537-63a4-41f9-8415-5ed05bd8cbcf 16571-214 HUMAN PRESCRIPTION DRUG Tindazole Tinidazole TABLET, FILM COATED ORAL 20131009 ANDA ANDA202489 Pack Pharmaceuticals, LLC TINIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 16571-215_3a66b537-63a4-41f9-8415-5ed05bd8cbcf 16571-215 HUMAN PRESCRIPTION DRUG Tindazole Tinidazole TABLET, FILM COATED ORAL 20131009 ANDA ANDA202489 Pack Pharmaceuticals, LLC TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 16571-301_dd66d0d4-e525-494c-8d77-2a3e737fc9a1 16571-301 HUMAN OTC DRUG Guaifenesin DAC Guaifenesin, Codeine Phosphate and Pseudoephedrine Hydrochloride LIQUID ORAL 20090928 UNAPPROVED OTHER Pack Pharmaceuticals LLC CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 100; 30 mg/5mL; mg/5mL; mg/5mL CV 16571-302_58e8c6ca-2f42-489b-a4c7-bcef9c81b61d 16571-302 HUMAN OTC DRUG Guaifenesin AC Guaifenesin and Codeine Phosphate SYRUP ORAL 20090922 OTC MONOGRAPH FINAL part341 Pack Pharmaceuticals LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 16571-303_7aa46114-6955-4568-a40a-bceddb47d38d 16571-303 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride LIQUID ORAL 20130923 UNAPPROVED DRUG OTHER Pack Pharmaceuticals LLC POTASSIUM CHLORIDE 40 meq/30mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 16571-304_6efbdeec-8ee4-4e53-8e15-af5236a1ef6a 16571-304 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride LIQUID ORAL 20140416 UNAPPROVED DRUG OTHER Pack Pharmaceuticals LLC POTASSIUM CHLORIDE 40 meq/15mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 16571-330_382a0b79-0a18-42b5-aba7-093a96c2ed2e 16571-330 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital LIQUID ORAL 20110708 UNAPPROVED DRUG OTHER Pack Pharmaceuticals, LLC PHENOBARBITAL 20 mg/5mL CIV 16571-401_7fb59305-2c6b-47fe-8c15-50260b86714a 16571-401 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Pack Pharmaceuticals LLC CETIRIZINE HYDROCHLORIDE 5 mg/1 16571-402_327f483b-a03b-4efa-95cb-ecb3c8c1c21f 16571-402 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Pack Pharmaceuticals LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 16571-411_9a068794-d780-4a4f-baf8-2a258be2c4be 16571-411 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Pack Pharmaceuticals, LLC CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16571-412_9a068794-d780-4a4f-baf8-2a258be2c4be 16571-412 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Pack Pharmaceuticals, LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16571-413_9a068794-d780-4a4f-baf8-2a258be2c4be 16571-413 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Pack Pharmaceuticals, LLC CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16571-421_b55863f0-5f4d-4e5f-b394-473bdfcf079b 16571-421 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100601 ANDA ANDA079220 Pack Pharmaceuticals, LLC ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 16571-430_d5072024-c824-4740-93af-02340db518ff 16571-430 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100610 ANDA ANDA077443 Pack Pharmaceuticals LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16571-431_d5072024-c824-4740-93af-02340db518ff 16571-431 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100610 ANDA ANDA077443 Pack Pharmaceuticals LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16571-441_d5072024-c824-4740-93af-02340db518ff 16571-441 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100610 ANDA ANDA077443 Pack Pharmaceuticals LLC ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16571-500_52bbae1e-fd7e-4ba6-97e7-7a6fe69a51ff 16571-500 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 20110601 ANDA ANDA091497 Pack Pharmaceuticals, LLC LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 16571-501_52bbae1e-fd7e-4ba6-97e7-7a6fe69a51ff 16571-501 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan potassium TABLET, FILM COATED ORAL 20140730 ANDA ANDA091497 Pack Pharmaceuticals, LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 16571-502_52bbae1e-fd7e-4ba6-97e7-7a6fe69a51ff 16571-502 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 20140730 ANDA ANDA091497 Pack Pharmaceuticals, LLC LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 16571-600_3309c828-39b5-4db4-bba2-d5bd43e86af5 16571-600 HUMAN PRESCRIPTION DRUG CROMOLYN SODIUM CROMOLYN SODIUM SOLUTION, CONCENTRATE ORAL 20111205 ANDA ANDA202583 Pack Pharmaceuticals, LLC CROMOLYN SODIUM 100 mg/5mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] 16571-657_4cea9db7-3b69-4969-9c59-c0a628efd084 16571-657 HUMAN PRESCRIPTION DRUG Cevimeline Hydrochloride Cevimeline Hydrochloride CAPSULE ORAL 20140617 ANDA ANDA203775 Pack Pharmaceuticals, LLC CEVIMELINE HYDROCHLORIDE 30 mg/1 Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 16590-002_9b3dcaf1-1471-4f98-af83-2ea3fef6b3ca 16590-002 HUMAN PRESCRIPTION DRUG ACULAR KETOROLAC TROMETHAMINE SOLUTION/ DROPS OPHTHALMIC 19921201 NDA NDA019700 STAT Rx USA LLC KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-003_b8d12ab6-1fd5-4f63-be4e-61b4ecd1a7b7 16590-003 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR TABLET ORAL 19980930 ANDA ANDA074980 Stat Rx USA ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 16590-005_435b1141-4c61-4200-b151-a596b91b2ef7 16590-005 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ALPRAZOLAM TABLET ORAL 20110325 ANDA ANDA074112 STAT Rx USA LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-006_435b1141-4c61-4200-b151-a596b91b2ef7 16590-006 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ALPRAZOLAM TABLET ORAL 20110325 ANDA ANDA074112 STAT Rx USA LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-007_46d7d49a-d8e8-40a4-9148-728e8c1805fb 16590-007 HUMAN PRESCRIPTION DRUG ALREX loteprednol etabonate SUSPENSION/ DROPS OPHTHALMIC 19980309 NDA NDA020803 STAT Rx USA LLC LOTEPREDNOL ETABONATE 2 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-008_5953d974-17ec-4a9c-9fca-3150a93620aa 16590-008 HUMAN PRESCRIPTION DRUG AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE CAPSULE ORAL 19870218 ANDA ANDA071293 STAT RX USA LLC AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 16590-009_01cc254d-230d-47d8-a69a-4ab71fcbb35a 16590-009 HUMAN PRESCRIPTION DRUG AMBIEN ZOLPIDEM TARTRATE TABLET, FILM COATED ORAL 19930401 NDA NDA019908 STAT Rx USA LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 16590-010_01cc254d-230d-47d8-a69a-4ab71fcbb35a 16590-010 HUMAN PRESCRIPTION DRUG AMBIEN ZOLPIDEM TARTRATE TABLET, FILM COATED ORAL 19930401 NDA NDA019908 STAT Rx USA LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 16590-011_c818e040-c641-4e26-a1cf-5d1f58692bd4 16590-011 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 STAT Rx USA LLC AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 16590-012_c818e040-c641-4e26-a1cf-5d1f58692bd4 16590-012 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 STAT Rx USA LLC AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 16590-013_c818e040-c641-4e26-a1cf-5d1f58692bd4 16590-013 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 STAT Rx USA LLC AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 16590-014_977202d3-3fae-47b1-a34b-ece32c56bf3a 16590-014 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN CAPSULE ORAL 20050911 ANDA ANDA065271 STAT Rx USA LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 16590-015_58fe5e04-a337-4c52-85f9-19468230a2d1 16590-015 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN POWDER, FOR SUSPENSION ORAL 20120413 ANDA ANDA061931 STAT Rx USA LLC AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 16590-016_977202d3-3fae-47b1-a34b-ece32c56bf3a 16590-016 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN CAPSULE ORAL 20050911 ANDA ANDA065271 STAT Rx USA LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 16590-017_2cedd392-c532-4f6f-847d-be1b7c09f69b 16590-017 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 STAT RX USA LLC AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 16590-018_58fe5e04-a337-4c52-85f9-19468230a2d1 16590-018 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN POWDER, FOR SUSPENSION ORAL 20120413 ANDA ANDA061931 STAT Rx USA LLC AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 16590-019_0794974f-7b64-456b-b745-cf9d48e3670d 16590-019 HUMAN PRESCRIPTION DRUG AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED ORAL 20110125 ANDA ANDA065101 STAT RX USA LLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 16590-020_61d1243f-2000-4fa0-a7d2-0df54d505c1e 16590-020 HUMAN PRESCRIPTION DRUG AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED ORAL 20021121 ANDA ANDA065093 STAT Rx USA LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 16590-022_dd087b8e-48c8-4893-ac50-d23c94bef372 16590-022 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN, BUTALBITAL AND CAFFEINE ACETAMINOPHEN, BUTALBITAL AND CAFFEINE TABLET ORAL 19880216 ANDA ANDA089536 STAT RX USA LLC ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 16590-023_02521de1-e1a3-40bb-ade1-632edb68961f 16590-023 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINe ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET ORAL 19880930 ANDA ANDA089805 STAT RX USA LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII 16590-024_6aa9bba9-9741-4291-9b63-bb1f6ec11f9a 16590-024 HUMAN PRESCRIPTION DRUG ARTHROTEC DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED ORAL 19971224 NDA NDA020607 STAT Rx USA LLC DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 16590-026_af7d40cc-756e-48ca-9eb3-f2fc8668541a 16590-026 HUMAN PRESCRIPTION DRUG BACLOFEN BACLOFEN TABLET ORAL 19910918 ANDA ANDA072824 STAT RX USA LLC BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 16590-027_af7d40cc-756e-48ca-9eb3-f2fc8668541a 16590-027 HUMAN PRESCRIPTION DRUG BACLOFEN BACLOFEN TABLET ORAL 19910918 ANDA ANDA072828 STAT RX USA LLC BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 16590-028_ca5af146-331e-458e-8558-eb2418897ae0 16590-028 HUMAN PRESCRIPTION DRUG BACTROBAN MUPIROCIN CALCIUM CREAM TOPICAL 19980123 NDA NDA050746 STAT RX USA LLC MUPIROCIN CALCIUM 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 16590-030_7bb2ffed-7319-4529-a679-74a2809bd144 16590-030 HUMAN PRESCRIPTION DRUG BECONASE AQ beclomethasone dipropionate monohydrate SPRAY, SUSPENSION NASAL 19891001 NDA NDA019389 Stat Rx USA LLC BECLOMETHASONE DIPROPIONATE MONOHYDRATE 42 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-031_b1166a9a-d484-4b4a-b251-299d7c3c3f0d 16590-031 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070730 ANDA ANDA040682 Stat Rx USA BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 16590-032_627265a7-41e4-4b92-a1e7-4ec928e142d8 16590-032 HUMAN PRESCRIPTION DRUG BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE CREAM TOPICAL 19840226 ANDA ANDA019137 STAT RX USA LLC BETAMETHASONE DIPROPIONATE .64 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-033_d7e06467-4044-4296-a786-2db9bf3dcd0b 16590-033 HUMAN PRESCRIPTION DRUG BETAMETHASONE CLOTRIMAZOLE BETAMETHASONE CLOTRIMAZOLE CREAM TOPICAL 20020802 ANDA ANDA076002 Stat Rx USA BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE .64; 10 mg/1; mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-034_12270cdd-7883-404e-a453-3df543de9c9e 16590-034 HUMAN PRESCRIPTION DRUG BETAMETHASONE VALERATE BETAMETHASONE VALERATE CREAM TOPICAL 20091023 ANDA ANDA018861 STAT RX USA LLC BETAMETHASONE VALERATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-036_83131c8f-7b87-4ca7-beb2-6e889579321b 16590-036 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 STAT RX USA LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 16590-037_7beeaf45-ce27-42a6-8c4d-aedc04648345 16590-037 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, FILM COATED ORAL 20100201 ANDA ANDA075491 STAT RX USA LLC BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 16590-038_83131c8f-7b87-4ca7-beb2-6e889579321b 16590-038 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 STAT RX USA LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 16590-039_a3270044-c999-4775-9a4a-61ac60552416 16590-039 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 19960124 ANDA ANDA040124 STAT RX USA LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 16590-043_20ce719a-5aff-4414-8afd-4ef693435f7b 16590-043 HUMAN PRESCRIPTION DRUG CEFADROXIL CEFADROXIL CAPSULE ORAL 20070125 ANDA ANDA065352 STAT RX USA LLC CEFADROXIL 500 mg/1 16590-045_f0b4dc59-0a50-49ca-a411-66a220b288b2 16590-045 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 19981002 NDA NDA020998 STAT RX USA LLC CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-046_f0b4dc59-0a50-49ca-a411-66a220b288b2 16590-046 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 19981002 NDA NDA020998 STAT RX USA LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-047_8b9a53f4-b0d4-4f7d-91d6-af0cdab841bd 16590-047 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20060718 ANDA ANDA040622 STAT RX USA LLC PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 16590-048_c49c8d62-78a9-433e-8407-b650e3426ffe 16590-048 HUMAN PRESCRIPTION DRUG CIMETIDINE CIMETIDINE TABLET, FILM COATED ORAL 19940517 ANDA ANDA074246 STAT RX USA LLC CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 16590-049_b99e6457-6384-408a-a8ea-b5d738145709 16590-049 HUMAN PRESCRIPTION DRUG CEPHALEXIN CEPHALEXIN POWDER, FOR SUSPENSION ORAL 20071204 ANDA ANDA065326 STAT RX USA LLC CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16590-050_375523b3-8c05-4810-9b33-c1d9d1dc95fd 16590-050 HUMAN PRESCRIPTION DRUG CEPHALEXIN CEPHALEXIN CAPSULE ORAL 20051116 ANDA ANDA065253 STAT RX USA LLC CEPHALEXIN 250 mg/1 16590-051_375523b3-8c05-4810-9b33-c1d9d1dc95fd 16590-051 HUMAN PRESCRIPTION DRUG CEPHALEXIN CEPHALEXIN CAPSULE ORAL 20051116 ANDA ANDA065253 STAT RX USA LLC CEPHALEXIN 500 mg/1 16590-052_05204334-548c-4f9c-a43a-36cb63a40c27 16590-052 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971022 ANDA ANDA040197 Stat Rx USA ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 16590-053_336c1808-842d-45f2-977b-df322af2d4bd 16590-053 HUMAN PRESCRIPTION DRUG Cipro HC ciprofloxacin hydrochloride SUSPENSION AURICULAR (OTIC) 19980210 NDA NDA020805 Stat Rx USA BENZYL ALCOHOL; CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE 9; 2; 10 mg/mL; mg/mL; mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Pediculicide [EPC] 16590-054_6425274d-a69e-4a0c-9426-47a121d5ae29 16590-054 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN TABLET ORAL 20040910 ANDA ANDA076639 STAT RX USA LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16590-055_a467eae7-67d3-4fdf-870f-8e7f6a92dc7a 16590-055 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET ORAL 20071018 ANDA ANDA078216 Stat Rx USA CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-056_a467eae7-67d3-4fdf-870f-8e7f6a92dc7a 16590-056 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET ORAL 20071018 ANDA ANDA078216 Stat Rx USA CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-057_358c451c-d6ca-46a2-bf4c-04e70b9bea31 16590-057 HUMAN PRESCRIPTION DRUG clindamycin hydrochloride clindamycin hydrochloride CAPSULE ORAL 20010202 ANDA ANDA065061 Stat Rx USA CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 16590-058_ca2d9e6e-542b-427e-8217-44082f7bc0b3 16590-058 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20090213 ANDA ANDA074869 STAT Rx USA LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-059_ca2d9e6e-542b-427e-8217-44082f7bc0b3 16590-059 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20090213 ANDA ANDA074869 STAT Rx USA LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-060_82a3de99-961a-4554-9a86-5b94b4304b5a 16590-060 HUMAN PRESCRIPTION DRUG CLOTRIMAZOLE CLOTRIMAZOLE CREAM TOPICAL 19930831 ANDA ANDA072640 STAT RX USA LLC CLOTRIMAZOLE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 16590-061_0692a48c-af11-43a4-9b2c-d3493bb23138 16590-061 HUMAN PRESCRIPTION DRUG Combivir lamivudine, zidovudine TABLET, FILM COATED ORAL 19970930 NDA NDA020857 Stat Rx USA LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 16590-064_ab81071b-e065-49bc-9eee-5ad4c42b8d29 16590-064 HUMAN PRESCRIPTION DRUG CRIXIVAN INDINAVIR SULFATE CAPSULE ORAL 19960313 NDA NDA020685 STAT Rx USA LLC INDINAVIR SULFATE 400 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 16590-065_e03702e3-d15b-451b-9d0e-83118f504d09 16590-065 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20100218 ANDA ANDA078218 STAT Rx USA LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 16590-068_ab150891-9554-497c-a8b1-4757beceaed1 16590-068 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC 19960726 ANDA ANDA040069 Stat Rx USA DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-069_9be59810-3ec8-4737-aa61-ec67fb9d3f20 16590-069 HUMAN PRESCRIPTION DRUG DIAZEPAM DIAZEPAM TABLET ORAL 20060331 ANDA ANDA077749 STAT RX USA LLC DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-070_9be59810-3ec8-4737-aa61-ec67fb9d3f20 16590-070 HUMAN PRESCRIPTION DRUG DIAZEPAM DIAZEPAM TABLET ORAL 20060331 ANDA ANDA077749 STAT RX USA LLC DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-071_9be59810-3ec8-4737-aa61-ec67fb9d3f20 16590-071 HUMAN PRESCRIPTION DRUG DIAZEPAM DIAZEPAM TABLET ORAL 20060331 ANDA ANDA077749 STAT RX USA LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-072_7114ae86-dbfe-41fd-90f5-8c68bf5f1015 16590-072 HUMAN PRESCRIPTION DRUG Diclofenac Potassium diclofenac potassium TABLET, FILM COATED ORAL 20040318 ANDA ANDA076561 Stat Rx USA DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-074_9733ed92-7e1f-45ca-bbcc-373aa6a61740 16590-074 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19950928 ANDA ANDA074376 Stat Rx USA DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-076_227eb33f-6063-4bc4-9f6e-950fd5e3973d 16590-076 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 20110120 ANDA ANDA062286 STAT RX USA LLC DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 16590-077_5badb39b-9b3b-4296-a05d-baed341675c7 16590-077 HUMAN PRESCRIPTION DRUG dicyclomine hydrochloride dicyclomine hydrochloride CAPSULE ORAL 19970228 ANDA ANDA040204 Stat Rx USA DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 16590-080_9bfe4e61-462b-454c-a4fe-7039b969801b 16590-080 HUMAN PRESCRIPTION DRUG Diphenoxylate Hcl and Atropine Sulfate Diphenoxylate Hcl and Atropine Sulfate TABLET ORAL 19791029 ANDA ANDA086727 Stat Rx USA ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 16590-081_f733e40a-bf95-4cb8-961a-d62e50b17c1b 16590-081 HUMAN PRESCRIPTION DRUG DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE ORAL 20110504 ANDA ANDA070791 STAT Rx USA LLC DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 16590-082_42e009a7-4d2e-4d72-b921-5674d4b858af 16590-082 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840507 ANDA ANDA062396 STAT Rx USA LLC DOXYCYCLINE HYCLATE 100 mg/1 16590-085_81933ecb-2fd6-46a3-bf39-6516701756f9 16590-085 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Stat Rx USA VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-086_81933ecb-2fd6-46a3-bf39-6516701756f9 16590-086 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Stat Rx USA VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-087_81933ecb-2fd6-46a3-bf39-6516701756f9 16590-087 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Stat Rx USA VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-088_7e700ae1-28d0-42ac-8946-fe2fc4799627 16590-088 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN ERYTHROMYCIN CAPSULE, DELAYED RELEASE ORAL 19861222 ANDA ANDA062746 Stat Rx USA ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 16590-089_b6941c8c-7cd4-4819-bc5d-562379209855 16590-089 HUMAN PRESCRIPTION DRUG ERY-TAB ERYTHROMYCIN TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 STAT Rx USA LLC ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 16590-090_75f96b89-4034-4478-9a4a-a910741f9a59 16590-090 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN ERYTHROMYCIN OINTMENT OPHTHALMIC 19940729 ANDA ANDA064067 Stat Rx USA ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 16590-091_b7aab831-9cb4-47a8-a000-89440aaf8949 16590-091 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN ERYTHROMYCIN TABLET, FILM COATED ORAL 19720711 ANDA ANDA061621 STAT RX USA LLC ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 16590-092_285cf73b-c582-4060-8ad7-e9a03a93259f 16590-092 HUMAN PRESCRIPTION DRUG ETODOLAC ETODOLAC TABLET ORAL 19980311 ANDA ANDA075074 STAT Rx USA LLC ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-096_f0d1d9cb-3a95-4389-8cc7-29634a1f227c 16590-096 HUMAN PRESCRIPTION DRUG FLURBIPROFEN FLURBIPROFEN TABLET, FILM COATED ORAL 19940620 ANDA ANDA074358 STAT RX USA LLC FLURBIPROFEN 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-097_d1019fb8-d3f5-4041-a201-17769e75a90f 16590-097 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide CREAM TOPICAL 19821216 ANDA ANDA088170 STAT RX USA LLC FLUOCINOLONE ACETONIDE .1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-099_1994a329-5704-4295-a915-6991132b74bd 16590-099 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20120320 ANDA ANDA076001 STAT Rx USA LLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-100_fec7bcb5-bc30-4915-9b85-1011eb399814 16590-100 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE HYDROCHLORIDE CAPSULE ORAL 20100429 ANDA ANDA075245 STAT RX USA LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-101_b2089365-a866-4a02-8acf-f26d5efc83f1 16590-101 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20041004 ANDA ANDA075350 STAT RX USA LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-102_b2089365-a866-4a02-8acf-f26d5efc83f1 16590-102 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20041004 ANDA ANDA075350 STAT RX USA LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-103_21ffab10-3a4c-4ba2-9f39-da6e8d71892d 16590-103 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET, FILM COATED ORAL 20040214 ANDA ANDA075694 STAT RX USA LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-104_1ba21d49-5931-4e11-b3de-0040f1a21c52 16590-104 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET, FILM COATED ORAL 20060824 ANDA ANDA077525 STAT RX USA LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-107_75426d61-72dc-41be-abda-689807061bec 16590-107 HUMAN PRESCRIPTION DRUG GENTAMICIN SULFATE GENTAMICIN SULFATE CREAM TOPICAL 20090811 ANDA ANDA062531 STAT RX USA LLC GENTAMICIN SULFATE 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 16590-112_0ed92691-c14e-4155-a631-cc631ce05a8d 16590-112 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 19910830 ANDA ANDA081079 STAT Rx USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 16590-113_386a97fb-d13f-4cd9-ac4f-143159d531a6 16590-113 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100129 ANDA ANDA089160 STAT RX USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 16590-114_0ed92691-c14e-4155-a631-cc631ce05a8d 16590-114 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20000912 ANDA ANDA040148 STAT Rx USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 16590-115_0ed92691-c14e-4155-a631-cc631ce05a8d 16590-115 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 19910830 ANDA ANDA081080 STAT Rx USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 16590-116_0ed92691-c14e-4155-a631-cc631ce05a8d 16590-116 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 19950929 ANDA ANDA040094 STAT Rx USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 16590-117_0ed92691-c14e-4155-a631-cc631ce05a8d 16590-117 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 19910830 ANDA ANDA081083 STAT Rx USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 16590-118_0ed92691-c14e-4155-a631-cc631ce05a8d 16590-118 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 19970214 ANDA ANDA040148 STAT Rx USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 16590-119_0ed92691-c14e-4155-a631-cc631ce05a8d 16590-119 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 19970214 ANDA ANDA040148 STAT Rx USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 16590-120_0ed92691-c14e-4155-a631-cc631ce05a8d 16590-120 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 19950929 ANDA ANDA040094 STAT Rx USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 16590-121_a0d6ba45-9693-4a30-ae92-9ed079f62cd4 16590-121 HUMAN PRESCRIPTION DRUG HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 20020103 ANDA ANDA087795 STAT Rx USA LLC HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-124_7ffe64e6-051b-4cec-aa71-90a88956d5cc 16590-124 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET ORAL 20081120 ANDA ANDA075682 STAT RX USA LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-125_7ffe64e6-051b-4cec-aa71-90a88956d5cc 16590-125 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET ORAL 20081120 ANDA ANDA075682 STAT RX USA LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-126_7ffe64e6-051b-4cec-aa71-90a88956d5cc 16590-126 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET ORAL 20081120 ANDA ANDA075682 STAT RX USA LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-129_4e757184-7fac-4636-9567-9a5d23b8a33f 16590-129 HUMAN PRESCRIPTION DRUG INDOMETHACIN INDOMETHACIN CAPSULE ORAL 20100915 NDA NDA018858 STAT RX USA LLC INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-130_2df3f2d0-87c8-4fd6-a5e1-3549af41417f 16590-130 HUMAN PRESCRIPTION DRUG INDOMETHACIN INDOMETHACIN CAPSULE ORAL 20100716 ANDA ANDA070756 STAT RX USA LLC INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-134_95f5a16a-5dd7-48b1-a20b-607369586eb1 16590-134 HUMAN PRESCRIPTION DRUG KEPPRA LEVETIRACETAM TABLET, FILM COATED ORAL 20000424 NDA NDA021035 STAT RX USA LLC LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-135_95f5a16a-5dd7-48b1-a20b-607369586eb1 16590-135 HUMAN PRESCRIPTION DRUG KEPPRA LEVETIRACETAM TABLET, FILM COATED ORAL 20000424 NDA NDA021035 STAT RX USA LLC LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-136_7ff402e2-27cc-44bb-bcd8-aa2d0f0a7305 16590-136 HUMAN PRESCRIPTION DRUG KETOPROFEN KETOPROFEN CAPSULE ORAL 20110118 ANDA ANDA073516 STAT RX USA LLC KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-137_7ff402e2-27cc-44bb-bcd8-aa2d0f0a7305 16590-137 HUMAN PRESCRIPTION DRUG KETOPROFEN KETOPROFEN CAPSULE ORAL 20110118 ANDA ANDA073517 STAT RX USA LLC KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-138_03ab2a51-f6ca-446c-931b-0445af7830c7 16590-138 HUMAN PRESCRIPTION DRUG KETOROLAC KETOROLAC TROMETHAMINE TABLET, FILM COATED ORAL 20100915 ANDA ANDA074761 STAT RX USA LLC KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-139_fe88f249-3a79-44a7-84a7-1d57a5424bc1 16590-139 HUMAN PRESCRIPTION DRUG LEXAPRO ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 STAT Rx USA LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-140_66d05ec9-9bfc-4f41-8e94-fd6e023e310f 16590-140 HUMAN PRESCRIPTION DRUG LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE SOLUTION ORAL; TOPICAL 19950710 ANDA ANDA040014 STAT RX LLC USA LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 16590-141_a1589f9b-3695-4bac-9ae1-83470753a88b 16590-141 HUMAN PRESCRIPTION DRUG LIDODERM LIDOCAINE PATCH CUTANEOUS 19990320 NDA NDA020612 STAT RX USA LLC LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 16590-143_08553c0f-22c7-48db-944d-6d42cbe5121b 16590-143 HUMAN PRESCRIPTION DRUG LORAZEPAM LORAZEPAM TABLET ORAL 19911031 ANDA ANDA072926 STAT RX USA LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-144_59644bee-0419-41bc-8b33-4608064096c0 16590-144 HUMAN PRESCRIPTION DRUG MAXALT-MLT RIZATRIPTAN BENZOATE TABLET, ORALLY DISINTEGRATING ORAL 19980629 NDA NDA020865 STAT RX USA LLC RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 16590-146_cb82475f-918f-4091-a61e-0d861b591a20 16590-146 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET ORAL 19810603 ANDA ANDA087128 STAT Rx USA LLC MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 16590-147_49999c49-5fae-48e5-a13b-1ebf2a5c5992 16590-147 HUMAN PRESCRIPTION DRUG METHOCARBAMOL METHOCARBAMOL TABLET ORAL 20000101 ANDA ANDA085159 STAT Rx USA LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 16590-148_49999c49-5fae-48e5-a13b-1ebf2a5c5992 16590-148 HUMAN PRESCRIPTION DRUG METHOCARBAMOL METHOCARBAMOL TABLET ORAL 20000101 ANDA ANDA085159 STAT Rx USA LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 16590-149_d1d9ca29-f3fb-4ee4-bbb7-16997d9755fc 16590-149 HUMAN PRESCRIPTION DRUG METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET ORAL 19971031 ANDA ANDA040189 STAT Rx USA LLC METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-150_05c88c61-5f5c-4c1f-b330-59342f173a79 16590-150 HUMAN PRESCRIPTION DRUG METOCLOPRAMIDE METOCLOPRAMIDE HYDROCHLORIDE TABLET ORAL 20060828 ANDA ANDA077878 STAT RX USA LLC METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 16590-151_05c88c61-5f5c-4c1f-b330-59342f173a79 16590-151 HUMAN PRESCRIPTION DRUG METOCLOPRAMIDE METOCLOPRAMIDE HYDROCHLORIDE TABLET ORAL 20060828 ANDA ANDA077878 STAT RX USA LLC METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 16590-152_241348b0-80ae-4ad1-bb93-b7cabf3f74c4 16590-152 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070033 STAT Rx USA LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 16590-153_0c211488-859d-4879-8586-eac4baf3b5df 16590-153 HUMAN PRESCRIPTION DRUG MIRTAZAPINE MIRTAZAPINE TABLET, FILM COATED ORAL 20030601 ANDA ANDA076312 STAT Rx USA LLC MIRTAZAPINE 15 mg/1 16590-154_0c211488-859d-4879-8586-eac4baf3b5df 16590-154 HUMAN PRESCRIPTION DRUG MIRTAZAPINE MIRTAZAPINE TABLET, FILM COATED ORAL 20030601 ANDA ANDA076312 STAT Rx USA LLC MIRTAZAPINE 30 mg/1 16590-155_0c211488-859d-4879-8586-eac4baf3b5df 16590-155 HUMAN PRESCRIPTION DRUG MIRTAZAPINE MIRTAZAPINE TABLET, FILM COATED ORAL 20030601 ANDA ANDA076312 STAT Rx USA LLC MIRTAZAPINE 45 mg/1 16590-158_f0cb8726-bb3a-4e87-aa09-b5bc008468a8 16590-158 HUMAN PRESCRIPTION DRUG MUPIROCIN MUPIROCIN OINTMENT TOPICAL 20031107 ANDA ANDA065123 STAT RX LLC USA MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 16590-160_3cf8c7a7-b186-476d-a216-d2278d1736b1 16590-160 HUMAN PRESCRIPTION DRUG NABUMETONE NABUMETONE TABLET ORAL 20030124 ANDA ANDA076009 STAT RX USA LLC NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-162_238c42d5-4896-4ec9-8fde-b37493383ffa 16590-162 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 STAT Rx USA LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-163_479edf50-1498-49b7-9b92-2e2c329d5ed4 16590-163 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110718 ANDA ANDA074201 STAT Rx USA LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-164_718a2975-da71-40cb-a53b-176170d1383a 16590-164 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 20100923 ANDA ANDA075227 STAT Rx USA LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-165_2545a4b5-25c6-4570-a26b-6a9fff2b6770 16590-165 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 19980218 ANDA ANDA074480 STAT Rx USA LLC NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-166_6c0e1c0c-fbcd-459a-9c35-36703cc6671f 16590-166 HUMAN PRESCRIPTION DRUG NEFAZODONE HYDROCHLORIDE NEFAZODONE HYDROCHLORIDE TABLET ORAL 20100818 ANDA ANDA076037 STAT RX USA LLC NEFAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 16590-167_d90b2b1d-b8be-4a67-a958-004d3277ac35 16590-167 HUMAN PRESCRIPTION DRUG NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE NEOMYCIN, POLYMYXIN B AND DEXAMETHASONE SUSPENSION OPHTHALMIC 19840522 ANDA ANDA062341 STAT RX LLC USA DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; U/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-169_96eb0830-9320-4d5c-8974-e5f6123fe2bd 16590-169 HUMAN PRESCRIPTION DRUG NEOMYCIN and POLYMYXIN B SULFATES and HYDROCORTISONE NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE SOLUTION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 STAT Rx USA LLC HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-170_571c78fc-228e-4063-b3c7-f5694fcd810d 16590-170 HUMAN PRESCRIPTION DRUG NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC NEOMYCIN, POLYMYXIN B AND BACITRACIN ZINC OINTMENT OPHTHALMIC 19951030 ANDA ANDA064064 STAT RX USA LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 1000 [USP'U]/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] 16590-171_44c31e61-575b-42e9-95bd-97d9530cb1ba 16590-171 HUMAN PRESCRIPTION DRUG NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE ORAL 19920701 ANDA ANDA073554 STAT RX USA LLC NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 16590-173_465beb51-3f95-458b-8d75-a9949a5d3a8b 16590-173 HUMAN PRESCRIPTION DRUG NYSTATIN AND TRIAMCINOLONE NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM TOPICAL 19871222 ANDA ANDA062364 STAT RX LLC USA NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 U/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-174_cc63d936-59f1-43c4-b1fc-836e5a05ab08 16590-174 HUMAN PRESCRIPTION DRUG NYSTATIN NYSTATIN SUSPENSION ORAL 20050628 ANDA ANDA065148 STAT Rx USA LLC NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 16590-175_0a55fe10-bdb0-4a63-96b3-3072d416b0c8 16590-175 HUMAN PRESCRIPTION DRUG OFLOXACIN OFLOXACIN SOLUTION/ DROPS OPHTHALMIC 20040514 ANDA ANDA076615 STAT RX LLC USA OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16590-177_11181c8a-34f6-4222-ae53-a6800a048543 16590-177 HUMAN PRESCRIPTION DRUG ORPHENADRINE CITRATE ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE ORAL 20000623 ANDA ANDA040368 STAT RX USA LLC ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 16590-178_2fc09a13-d7bd-4783-a02c-217a56647f12 16590-178 HUMAN PRESCRIPTION DRUG OXAPROZIN OXAPROZIN TABLET ORAL 20010131 ANDA ANDA075855 STAT RX USA LLC OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-181_975d7cf8-921c-4f06-861c-b1488ac2959e 16590-181 HUMAN PRESCRIPTION DRUG PAROXETINE PAROXETINE TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 STAT Rx USA LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-185_87c87622-e8fc-491e-bae5-5efbd066715c 16590-185 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE ORAL 20071201 ANDA ANDA087022 STAT RX USA LLC PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 16590-186_02e05ca9-eceb-42e1-8af7-4cba7f823b77 16590-186 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040526 STAT Rx USA LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 16590-187_6a9b608f-21da-4ca8-a867-677c1f60d4c4 16590-187 HUMAN PRESCRIPTION DRUG PIROXICAM PIROXICAM CAPSULE ORAL 20101102 ANDA ANDA074131 STAT RX USA LLC PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-188_6a9b608f-21da-4ca8-a867-677c1f60d4c4 16590-188 HUMAN PRESCRIPTION DRUG PIROXICAM PIROXICAM CAPSULE ORAL 20101102 ANDA ANDA074131 STAT RX USA LLC PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-191_1da81bc5-8f67-4dd4-a355-da66b55d6d51 16590-191 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19730919 ANDA ANDA083426 STAT Rx USA LLC PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 16590-195_3d7957b9-5a6a-45db-9c9d-712ce6bc07ea 16590-195 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION OPHTHALMIC 20000605 ANDA ANDA080027 STAT Rx USA LLC PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] 16590-198_785b0801-a724-42b2-a5f8-85562107ffc3 16590-198 HUMAN PRESCRIPTION DRUG Propoxyphene Propoxyphene Hydrochloride CAPSULE ORAL 20091027 ANDA ANDA040569 Stat Rx USA PROPOXYPHENE HYDROCHLORIDE 65 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 16590-200_9245213f-f306-463c-87ce-ab02ae25c18a 16590-200 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 20091216 ANDA ANDA077824 STAT Rx USA LLC RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 16590-201_35d62b7d-19d8-4c68-a58b-9479054034f4 16590-201 HUMAN PRESCRIPTION DRUG Relpax eletriptan hydrobromide TABLET, FILM COATED ORAL 20021226 NDA NDA021016 STAT Rx USA LLC ELETRIPTAN HYDROBROMIDE 40 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 16590-202_5dd52998-a60b-47d1-a224-a9248e8d0e3a 16590-202 HUMAN PRESCRIPTION DRUG Rimantadine Hydrochloride Rimantadine Hydrochloride TABLET, FILM COATED ORAL 20050401 ANDA ANDA076132 STAT Rx USA LLC RIMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 16590-206_074e18fc-9828-407a-a28d-c640707c80e7 16590-206 HUMAN PRESCRIPTION DRUG SSD silver sulfadiazine CREAM TOPICAL 19970918 NDA NDA018578 STAT Rx USA LLC SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 16590-207_dd5b644a-db40-423e-9ef0-3d90bd1873bb 16590-207 HUMAN PRESCRIPTION DRUG SKELAXIN metaxalone TABLET ORAL 20020830 NDA NDA013217 STAT Rx USA LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 16590-209_1c9f771c-6cce-4822-95e7-735d429a8b87 16590-209 HUMAN PRESCRIPTION DRUG SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM SOLUTION/ DROPS OPHTHALMIC 19881018 ANDA ANDA089560 STAT RX USA LLC SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 16590-210_3710dbca-95a7-4af0-b2ee-d49941193e90 16590-210 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20070125 ANDA ANDA078060 STAT Rx USA LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 16590-211_5c5688e6-0b85-4645-9c89-4dfe9b5305ef 16590-211 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20100125 ANDA ANDA072711 STAT Rx USA LLC SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-214_018712fb-ddc7-413a-a997-3c4be8395bf9 16590-214 HUMAN PRESCRIPTION DRUG TEMAZEPAM TEMAZEPAM CAPSULE ORAL 19870807 ANDA ANDA071638 STAT Rx USA LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-215_f94b2e61-1dcf-49cb-b237-8ffbc3934d09 16590-215 HUMAN PRESCRIPTION DRUG CEFUROXIME AXETIL CEFUROXIME AXETIL TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 STAT Rx USA LLC CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16590-216_8747eb4c-e4d4-4bb7-93fe-c2a0c84ab931 16590-216 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20100323 ANDA ANDA060704 STAT Rx USA LLC TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 16590-217_8747eb4c-e4d4-4bb7-93fe-c2a0c84ab931 16590-217 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20100323 ANDA ANDA060704 STAT Rx USA LLC TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 16590-220_2947079f-29d7-4752-86f1-424025a52910 16590-220 HUMAN PRESCRIPTION DRUG TIZANIDINE TIZANIDINE TABLET ORAL 20020703 ANDA ANDA076286 STAT Rx USA LLC TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 16590-221_2947079f-29d7-4752-86f1-424025a52910 16590-221 HUMAN PRESCRIPTION DRUG TIZANIDINE TIZANIDINE TABLET ORAL 20020703 ANDA ANDA076286 STAT Rx USA LLC TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 16590-223_601678b4-0feb-47f3-bf95-4e226ef5e6a5 16590-223 HUMAN PRESCRIPTION DRUG TOBRADEX TOBRAMYCIN and DEXAMETHASONE SUSPENSION OPHTHALMIC 19880915 NDA NDA050592 STAT Rx USA LLC DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-224_42cfee4b-735d-4a82-82ff-2359f6ec4b52 16590-224 HUMAN PRESCRIPTION DRUG TOBRAMYCIN TOBRAMYCIN SOLUTION/ DROPS OPHTHALMIC 19960131 ANDA ANDA064096 STAT Rx USA LLC TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 16590-225_8745c43f-60b7-4738-afc4-8893f319aba8 16590-225 HUMAN PRESCRIPTION DRUG TOBREX TOBRAMYCIN OINTMENT OPHTHALMIC 19811125 NDA NDA050555 STAT RX LLC USA TOBRAMYCIN 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 16590-229_786ee50f-ebc5-4521-b67b-3b30c58f8b88 16590-229 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET ORAL 20020622 ANDA ANDA075964 STAT Rx USA LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 16590-230_7b4909e3-249e-4081-a6fb-d129e27c486a 16590-230 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET, COATED ORAL 20010815 NDA NDA021123 STAT Rx USA LLC ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 16590-231_2741a2e3-3f20-4ecf-87c5-69dbbb62a3d8 16590-231 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19871211 ANDA ANDA071523 STAT RX LLC USA TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 16590-232_2741a2e3-3f20-4ecf-87c5-69dbbb62a3d8 16590-232 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19871211 ANDA ANDA071524 STAT RX LLC USA TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 16590-233_23d96fce-1ca2-4c4c-a5b2-03a2c32957db 16590-233 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim SOLUTION OPHTHALMIC 19980413 ANDA ANDA064211 STAT RX LLC USA POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 1/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 16590-234_8a881b93-ccd0-434e-aff7-22b6a634e04b 16590-234 HUMAN PRESCRIPTION DRUG TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM TOPICAL 19810409 ANDA ANDA086414 STAT RX LLC USA TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-236_0a196ef7-387d-46cf-bab1-5ae6f1a133c2 16590-236 HUMAN PRESCRIPTION DRUG TRIAZOLAM TRIAZOLAM TABLET ORAL 19821115 NDA AUTHORIZED GENERIC NDA017892 STAT RX USA LLC TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-242_f72fad5e-5737-45bc-bc68-a76e096f3c42 16590-242 HUMAN PRESCRIPTION DRUG NAPRELAN NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081219 NDA NDA020353 STAT RX USA NAPROXEN SODIUM 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-244_8ffc2065-e3b6-420a-a00d-643b839a27d6 16590-244 HUMAN PRESCRIPTION DRUG RYZOLT TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20081230 NDA NDA021745 Stat Rx USA TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 16590-246_24d51554-b3bd-4651-93ad-34d8f6ff1a0a 16590-246 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20091223 NDA NDA021515 STAT Rx USA LLC BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 16590-250_e37735f3-49fd-402b-9282-7498297f2df5 16590-250 HUMAN PRESCRIPTION DRUG ZOLOFT SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19920211 NDA NDA019839 STAT RX USA LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-251_e37735f3-49fd-402b-9282-7498297f2df5 16590-251 HUMAN PRESCRIPTION DRUG ZOLOFT SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19920211 NDA NDA019839 STAT RX USA LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-253_8ffc2065-e3b6-420a-a00d-643b839a27d6 16590-253 HUMAN PRESCRIPTION DRUG RYZOLT TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20081230 NDA NDA021745 Stat Rx USA TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 16590-254_466ac927-6b60-4932-8260-dbd38aaedd6b 16590-254 HUMAN PRESCRIPTION DRUG Megace ES MEGESTROL ACETATE SUSPENSION ORAL 20050608 NDA NDA021778 Stat Rx USA MEGESTROL ACETATE 125 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 16590-255_8ffc2065-e3b6-420a-a00d-643b839a27d6 16590-255 HUMAN PRESCRIPTION DRUG RYZOLT TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20081230 NDA NDA021745 Stat Rx USA TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 16590-256_3eb4efec-1779-42e6-818a-9e13d1e28e5d 16590-256 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 STAT RX USA LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16590-257_3eb4efec-1779-42e6-818a-9e13d1e28e5d 16590-257 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 STAT RX USA LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16590-259_2857adf2-a7a9-431f-bbff-9698f3eddb14 16590-259 HUMAN PRESCRIPTION DRUG BENAZEPRIL BENAZEPRIL HYDROCHLORIDE TABLET ORAL 20100202 ANDA ANDA076820 STAT RX USA LLC BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 16590-265_3aa48a88-2fac-4ee1-b268-38d7a65c1fd8 16590-265 HUMAN PRESCRIPTION DRUG CIMETIDINE CIMETIDINE TABLET, FILM COATED ORAL 20100526 ANDA ANDA074424 STAT RX USA LLC CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 16590-266_40b77ba7-18cb-40da-a4e1-007d029f1dfe 16590-266 HUMAN PRESCRIPTION DRUG CLONIDINE CLONIDINE HCL TABLET ORAL 19861216 ANDA ANDA070974 STAT RX USA LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 16590-267_5dcbeb73-e8a4-42ee-a2f8-68f2b4cc7aff 16590-267 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET ORAL 20090903 ANDA ANDA070317 STAT Rx USA LLC CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 16590-269_4c9735ec-f036-4a2c-ab34-2dbe78a643b9 16590-269 HUMAN PRESCRIPTION DRUG DEXAMETHASONE DEXAMETHASONE TABLET ORAL 19780719 ANDA ANDA084612 STAT Rx USA LLC DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-270_fb85af0f-efaa-4a94-a431-d30f6b3eb035 16590-270 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET ORAL 20080414 NDA NDA022235 Stat Rx USA FLUVOXAMINE MALEATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-274_7871ad1d-e39b-4673-b9f7-6c0cdbe11409 16590-274 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20091027 ANDA ANDA075509 Stat Rx USA DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 16590-276_0668cf36-9dcd-428f-9865-b40e52e4e4b4 16590-276 HUMAN PRESCRIPTION DRUG Reprexain Hydrocodone Bitartrate, Ibuprofen TABLET ORAL 20081216 ANDA ANDA076642 Stat Rx USA HYDROCODONE BITARTRATE; IBUPROFEN 10; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 16590-277_445485b0-6dd2-4c4e-8f73-131ea84c35af 16590-277 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 STAT Rx USA LLC ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 16590-278_934904c6-a3c4-4d62-b1d6-3407222194e1 16590-278 HUMAN PRESCRIPTION DRUG ESTRADIOL ESTRADIOL TABLET ORAL 19960314 ANDA ANDA040114 STAT Rx USA LLC ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 16590-279_90b51ce7-1a7a-446f-8207-90ca5185fe99 16590-279 HUMAN PRESCRIPTION DRUG Uroxatral Alfuzosin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090605 NDA NDA021287 Stat Rx USA ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 16590-280_8cc0f41f-c575-4896-be72-316bcb8c3675 16590-280 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20091027 ANDA ANDA076820 Stat Rx USA BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 16590-281_a027328f-3b19-4bf6-a016-b5c60881a6a7 16590-281 HUMAN PRESCRIPTION DRUG FAMOTIDINE FAMOTIDINE TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 STAT Rx USA LLC FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 16590-282_b8b41dd4-96c7-4144-a258-8dbd1331d885 16590-282 HUMAN PRESCRIPTION DRUG FLUCONAZOLE FLUCONAZOLE TABLET ORAL 20060125 ANDA ANDA077253 STAT RX USA LLC FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 16590-283_043eae07-74d3-4fb0-a32a-3eb2ddfa940c 16590-283 HUMAN PRESCRIPTION DRUG FLUCONAZOLE FLUCONAZOLE TABLET ORAL 20040729 ANDA ANDA076077 STAT Rx USA LLC FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 16590-284_73e03da9-6ab6-45d2-8dce-20292b6d3491 16590-284 HUMAN PRESCRIPTION DRUG FUROSEMIDE FUROSEMIDE TABLET ORAL 20060201 ANDA ANDA077293 STAT Rx USA LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 16590-285_91530375-fecc-40af-83ec-efcc485a1d56 16590-285 HUMAN PRESCRIPTION DRUG CILOSTAZOL CILOSTAZOL TABLET ORAL 20060906 ANDA ANDA077022 STAT RX USA LLC CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 16590-286_056e6844-f4bb-48cb-90ce-d5952388fbb7 16590-286 HUMAN PRESCRIPTION DRUG GLIPIZIDE GLIPIZIDE TABLET ORAL 19950227 ANDA ANDA074223 STAT Rx USA LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 16590-287_056e6844-f4bb-48cb-90ce-d5952388fbb7 16590-287 HUMAN PRESCRIPTION DRUG GLIPIZIDE GLIPIZIDE TABLET ORAL 19950227 ANDA ANDA074223 STAT Rx USA LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 16590-288_d23a7219-c75a-41ba-8be3-e2c81004d140 16590-288 HUMAN PRESCRIPTION DRUG PLAVIX CLOPIDOGREL BISULFATE TABLET, FILM COATED ORAL 19000101 NDA NDA020839 STAT RX USA LLC CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 16590-289_5553cf98-1f48-4867-94ee-8ea7544fa331 16590-289 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20090601 NDA NDA022304 Stat Rx USA TAPENTADOL HYDROCHLORIDE 100 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 16590-291_3049d682-7471-4093-86c3-47b236ea4e0f 16590-291 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 20030227 ANDA ANDA040401 Stat Rx USA PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-292_397f467e-aa49-455f-9e25-c61cb543a5ad 16590-292 HUMAN PRESCRIPTION DRUG Promethazine DM Promethazine DM SYRUP ORAL 20060214 ANDA ANDA040649 Stat Rx USA DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 16590-293_05de5d00-ae7c-44df-ab5c-1b8dca973647 16590-293 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 STAT Rx USA LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 16590-294_b23bea98-f462-4e6a-8dc9-519a935e4389 16590-294 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 20100402 ANDA ANDA083177 STAT RX USA LLC HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 16590-295_6d883f68-e3a9-41df-bbbd-8c99a1ea411b 16590-295 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070906 ANDA ANDA078500 STAT RX USA LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 16590-296_a08366e3-412d-47c5-9ff4-b078d01be6e7 16590-296 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20061106 ANDA ANDA077723 STAT RX USA LLC HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 16590-298_0ed22147-b9a2-44e2-baef-3ef978ab549f 16590-298 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100427 ANDA ANDA078938 STAT RX USA LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 16590-299_42e009a7-4d2e-4d72-b921-5674d4b858af 16590-299 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19841107 ANDA ANDA062396 STAT Rx USA LLC DOXYCYCLINE HYCLATE 50 mg/1 16590-300_72bfaee1-e145-430a-973b-1b68cddd7233 16590-300 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET, FILM COATED ORAL 20080701 NDA NDA020132 Stat Rx USA SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 16590-301_cb82475f-918f-4091-a61e-0d861b591a20 16590-301 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET ORAL 19810603 ANDA ANDA087127 STAT Rx USA LLC MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 16590-302_390d8d63-f378-4962-9329-2f3de24e91ea 16590-302 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20031201 NDA NDA021210 STAT Rx USA LLC LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 16590-303_fe7ae01c-1a8f-40b4-9898-00677e3c4527 16590-303 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090320 ANDA ANDA090097 Stat Rx USA LIOTHYRONINE SODIUM 50 1/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 16590-304_c50c130d-04ef-49df-8f0e-cc723d623eb1 16590-304 HUMAN PRESCRIPTION DRUG OXAZEPAM OXAZEPAM CAPSULE ORAL 19880414 ANDA ANDA072252 STAT RX USA LLC OXAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-305_7717debf-b8f7-4ee8-a137-c1faefa471a5 16590-305 HUMAN PRESCRIPTION DRUG TRIFLUOPERAZINE TRIFLUOPERAZINE TABLET, FILM COATED ORAL 19811120 ANDA ANDA085786 STAT RX USA LLC TRIFLUOPERAZINE HYDROCHLORIDE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 16590-306_e5b18084-c8e4-473c-a21b-c1ebe987319d 16590-306 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20051117 ANDA ANDA077321 STAT RX USA LLC LISINOPRIL 10 mg/1 16590-307_164bb521-4986-4fd1-8135-e6fb3bd103b3 16590-307 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20070419 ANDA ANDA078402 STAT Rx USA LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16590-308_01761807-9d72-4fea-8cc2-fe6f942d085c 16590-308 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20061004 ANDA ANDA077912 STAT Rx USA LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16590-309_01761807-9d72-4fea-8cc2-fe6f942d085c 16590-309 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20061004 ANDA ANDA077912 STAT Rx USA LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16590-311_33221ee2-b16c-4ef7-b0b4-083cb76b0bf3 16590-311 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20071101 ANDA ANDA078296 STAT Rx USA LLC LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16590-312_b5efa9dd-dfa3-48d6-8f44-0e0976b249f1 16590-312 HUMAN PRESCRIPTION DRUG DIOVAN HCT HYDROCHLOROTHIAZIDE, VALSARTAN TABLET, FILM COATED ORAL 20060428 NDA NDA020818 STAT RX USA LLC HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 16590-313_ffed4b56-292f-4375-9c8d-559c91b6461d 16590-313 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 STAT Rx USA LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 16590-317_6e2fc3d3-a1c8-4f0b-a65d-441ed623fc3d 16590-317 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET, FILM COATED ORAL 19940527 ANDA ANDA074217 STAT RX USA LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16590-319_7936ce47-f8e9-4886-b8ae-a4d20a26f0b0 16590-319 HUMAN PRESCRIPTION DRUG NIFEDIPINE NIFEDIPINE CAPSULE, LIQUID FILLED ORAL 19890428 ANDA ANDA072579 STAT RX USA LLC NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 16590-320_198dea39-a961-4bf1-a2c2-2410abae1b51 16590-320 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET ORAL 20090115 ANDA ANDA078858 STAT RX USA LLC LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-322_eda59a29-1e6e-4fc5-bbe3-ee180b94e4c9 16590-322 HUMAN PRESCRIPTION DRUG PAROXETINE PAROXETINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 STAT Rx USA LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-323_d748143d-23e9-412b-8bde-579254958f63 16590-323 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 STAT RX USA LLC ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] 16590-324_34ab4299-9cbb-4dd3-8967-3fc3107d8725 16590-324 HUMAN PRESCRIPTION DRUG DICYCLOMINE DICYCLOMINE HYDROCHLORIDE TABLET ORAL 19961001 ANDA ANDA040161 STAT RX USA LLC DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 16590-326_3d40bcf7-6ef8-4169-a077-a9a132ea82f7 16590-326 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 19740226 ANDA ANDA083677 STAT Rx USA LLC PREDNISONE 20 mg/1 16590-327_f58f9a60-2d11-4f86-98bd-498d4e7b71a6 16590-327 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE PROCHLORPERAZINE MALEATE TABLET ORAL 20090729 ANDA ANDA040120 STAT RX USA LLC PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 16590-334_9c3bf050-d416-49bc-bcdf-074ff4d1d874 16590-334 HUMAN PRESCRIPTION DRUG PRILOSEC OMEPRAZOLE MAGNESIUM CAPSULE ORAL 20090930 NDA NDA019810 STAT RX USA LLC OMEPRAZOLE MAGNESIUM 20 mg/1 16590-337_d77ce38d-a3c7-48a6-93eb-76f30af59ffd 16590-337 HUMAN PRESCRIPTION DRUG STRATTERA ATOMXETINE HYROCHLORIDE CAPSULE ORAL 20090316 NDA NDA021411 STAT RX USA LLC ATOMOXETINE HYDROCHLORIDE 10 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 16590-338_73b2d62b-1b3f-49a5-a6b8-407b374f22a5 16590-338 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA073449 STAT Rx USA LLC HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 16590-339_e8557f6e-7fa4-48b2-97d8-8f414c35a151 16590-339 HUMAN PRESCRIPTION DRUG VENTOLIN HFA ALBUTEROL SULFATE AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 STAT RX USA LLC ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 16590-340_bf066fee-a2cf-4016-bfd0-925f9aa68f9a 16590-340 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 STAT Rx USA LLC WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 16590-341_bf066fee-a2cf-4016-bfd0-925f9aa68f9a 16590-341 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 STAT Rx USA LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 16590-345_8bb2ff27-f4a9-468f-bb6f-4a6635bdbead 16590-345 HUMAN PRESCRIPTION DRUG NUVIGIL ARMODAFINIL TABLET ORAL 20090601 NDA NDA021875 STAT Rx USA LLC ARMODAFINIL 150 mg/1 CIV 16590-346_63ff7dae-98ae-4c78-8f83-6d208b0f1243 16590-346 HUMAN PRESCRIPTION DRUG METAXALONE METAXALONE TABLET ORAL 20071101 NDA NDA013217 STAT Rx USA LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 16590-347_7b0183bf-d621-4f73-9ee1-0729b4731cfe 16590-347 HUMAN PRESCRIPTION DRUG NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE SUSPENSION OPHTHALMIC 19830825 ANDA ANDA062423 STAT RX USA LLC HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-349_04cdc3d0-abb8-4415-9d77-008fda293e69 16590-349 HUMAN PRESCRIPTION DRUG URSODIOL URSODIOL CAPSULE ORAL 19871231 NDA NDA019594 STAT RX USA LLC URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 16590-350_fce3f9a3-7c70-42e7-8f6c-c476225debaa 16590-350 HUMAN PRESCRIPTION DRUG ZYDONE HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 19981201 ANDA ANDA040288 STAT RX USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 400; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 16590-356_164bb521-4986-4fd1-8135-e6fb3bd103b3 16590-356 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20070419 ANDA ANDA078402 STAT Rx USA LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16590-357_ab56b57d-9541-40d8-b550-c7a6af0a529c 16590-357 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 19811214 ANDA ANDA087479 STAT Rx USA LLC HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 16590-361_e9dc3ce6-9c97-4881-b89e-eb1a5e552373 16590-361 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 19810821 ANDA ANDA087508 STAT RX USA LLC ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/mL; mg/mL CV 16590-364_4fea6620-7a14-4e70-a749-7dbbf11815b1 16590-364 HUMAN PRESCRIPTION DRUG HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 20040312 ANDA ANDA040503 STAT Rx USA LLC HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-365_48465fb1-033c-42bd-acd3-34547985bd8c 16590-365 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20020712 ANDA ANDA040256 STAT Rx USA LLC PREDNISONE 5 mg/1 16590-368_0aca5247-a8db-42a4-9508-b503180613f8 16590-368 HUMAN PRESCRIPTION DRUG FLUOCINONIDE FLUOCINONIDE CREAM TOPICAL 19941017 ANDA ANDA073030 STAT RX USA LLC FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-370_b8d12ab6-1fd5-4f63-be4e-61b4ecd1a7b7 16590-370 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR TABLET ORAL 19980930 ANDA ANDA074980 Stat Rx USA ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 16590-372_3aa48a88-2fac-4ee1-b268-38d7a65c1fd8 16590-372 HUMAN PRESCRIPTION DRUG CIMETIDINE CIMETIDINE TABLET, FILM COATED ORAL 20100526 ANDA ANDA074424 STAT RX USA LLC CIMETIDINE 800 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 16590-373_3d40bcf7-6ef8-4169-a077-a9a132ea82f7 16590-373 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 19720522 ANDA ANDA080292 STAT Rx USA LLC PREDNISONE 5 mg/1 16590-375_6643a869-8281-4fda-893e-5c3a390899c5 16590-375 HUMAN PRESCRIPTION DRUG BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET ORAL 20111005 ANDA ANDA076008 STAT Rx USA LLC BUSPIRONE HYDROCHLORIDE 30 mg/1 16590-376_c8abb773-c2ee-4549-a770-bef1b9c073c6 16590-376 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE SOLUTION OPHTHALMIC 20091105 ANDA ANDA078434 STAT RX USA LLC KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-380_2e262fa7-df36-46df-9de3-34aa0f5ca7d6 16590-380 HUMAN PRESCRIPTION DRUG NITROFURANTOIN MACROCRYSTALS NITROFURANTOIN MACROCRYSTALS CAPSULE ORAL 19930128 ANDA ANDA073652 STAT RX USA LLC NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 16590-381_9245213f-f306-463c-87ce-ab02ae25c18a 16590-381 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 20091216 ANDA ANDA077824 STAT Rx USA LLC RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 16590-383_ad7c365c-4f5d-4f61-bf7e-8e0adc698e76 16590-383 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065405 STAT RX USA LLC AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 16590-385_241348b0-80ae-4ad1-bb93-b7cabf3f74c4 16590-385 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070027 STAT Rx USA LLC METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 16590-394_8bb2ff27-f4a9-468f-bb6f-4a6635bdbead 16590-394 HUMAN PRESCRIPTION DRUG NUVIGIL ARMODAFINIL TABLET ORAL 20090601 NDA NDA021875 STAT Rx USA LLC ARMODAFINIL 250 mg/1 CIV 16590-396_9aaf06fe-368d-4e62-a146-40925d49668d 16590-396 HUMAN PRESCRIPTION DRUG FROVA FROVATRIPTAN SUCCINATE TABLET, FILM COATED ORAL 20011108 NDA NDA021006 STAT RX USA LLC FROVATRIPTAN SUCCINATE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 16590-397_ffed4b56-292f-4375-9c8d-559c91b6461d 16590-397 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 STAT Rx USA LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 16590-401_949acebe-050c-43bd-8c50-a6e6c2e7d015 16590-401 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 STAT RX USA LLC AMOXICILLIN 400 mg/5mL 16590-403_390d8d63-f378-4962-9329-2f3de24e91ea 16590-403 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20031201 NDA NDA021210 STAT Rx USA LLC LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 16590-408_4e91211c-e54e-40bd-960e-c6fc149c50f2 16590-408 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET ORAL 20091117 ANDA ANDA076847 STAT Rx USA LLC SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 16590-409_a18209da-d004-4265-b7a7-41ccef918f78 16590-409 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20100101 ANDA ANDA077724 STAT RX USA LLC PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 16590-416_0bb2793e-4ec9-46a1-b450-94f2aa8c28f6 16590-416 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET ORAL 20071218 ANDA ANDA077397 STAT Rx USA LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-421_ffaef770-f31e-4ed0-b35c-aedf2b7a57c2 16590-421 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE SOLUTION OPHTHALMIC 20040507 NDA AUTHORIZED GENERIC NDA019992 STAT Rx USA LLC CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16590-422_9d7f97b6-2970-43ef-95d9-a3b906441819 16590-422 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN SUSPENSION ORAL 20041208 ANDA ANDA076925 STAT Rx USA LLC IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-423_c0ddde15-4b50-4e1c-a7d3-80e3dfa02829 16590-423 HUMAN PRESCRIPTION DRUG LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE CAPSULE ORAL 19930501 ANDA ANDA073192 STAT Rx USA LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 16590-434_e56a32d1-031d-4453-b0c3-05f5a530e5d4 16590-434 HUMAN PRESCRIPTION DRUG MELOXICAM MELOXICAM TABLET ORAL 20070307 ANDA ANDA077927 STAT RX USA LLC MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-436_91997190-be59-4965-8320-c691031fa9c8 16590-436 HUMAN PRESCRIPTION DRUG AMBIEN CR ZOLPIDEM TARTRATE TABLET, COATED ORAL 20090630 NDA NDA021774 STAT Rx USA LLC ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 16590-437_b028683b-330e-488b-980d-cae49998685c 16590-437 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20091119 ANDA ANDA086009 STAT RX USA LLC AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 16590-447_1169e8ca-38d2-439c-a995-97b5fe40964c 16590-447 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ALPRAZOLAM TABLET ORAL 19931031 ANDA ANDA074342 STAT Rx USA LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-453_cd2f16cd-e4db-4e3c-9e4d-cc1504b5a33d 16590-453 HUMAN PRESCRIPTION DRUG PENNSAID DICLOFENAC SODIUM LIQUID TOPICAL 20100405 NDA NDA020947 STAT RX USA LLC DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-457_0bb2793e-4ec9-46a1-b450-94f2aa8c28f6 16590-457 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET ORAL 20071218 ANDA ANDA077397 STAT Rx USA LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-461_59644bee-0419-41bc-8b33-4608064096c0 16590-461 HUMAN PRESCRIPTION DRUG MAXALT RIZATRIPTAN BENZOATE TABLET ORAL 19980629 NDA NDA020864 STAT RX USA LLC RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 16590-466_b99e6457-6384-408a-a8ea-b5d738145709 16590-466 HUMAN PRESCRIPTION DRUG CEPHALEXIN CEPHALEXIN POWDER, FOR SUSPENSION ORAL 20071207 ANDA ANDA065326 STAT RX USA LLC CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16590-469_e56a32d1-031d-4453-b0c3-05f5a530e5d4 16590-469 HUMAN PRESCRIPTION DRUG MELOXICAM MELOXICAM TABLET ORAL 20070307 ANDA ANDA077927 STAT RX USA LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-475_1b09f720-9416-475a-8b4c-325d7b87299f 16590-475 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20091208 ANDA ANDA070541 STAT RX USA LLC CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 16590-478_8eaf161b-ce95-4c0c-86fa-45f57c311bf7 16590-478 HUMAN PRESCRIPTION DRUG CHLORZOXAZONE CHLORZOXAZONE TABLET ORAL 20081223 ANDA ANDA089859 STAT Rx USA LLC CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 16590-480_a467eae7-67d3-4fdf-870f-8e7f6a92dc7a 16590-480 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET ORAL 20071018 ANDA ANDA078216 Stat Rx USA CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-481_ca2d9e6e-542b-427e-8217-44082f7bc0b3 16590-481 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20090213 ANDA ANDA074869 STAT Rx USA LLC CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-488_285cf73b-c582-4060-8ad7-e9a03a93259f 16590-488 HUMAN PRESCRIPTION DRUG ETODOLAC ETODOLAC CAPSULE ORAL 19980430 ANDA ANDA075078 STAT Rx USA LLC ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-489_9abe5de1-ab2a-4f88-90dc-dc671884e243 16590-489 HUMAN PRESCRIPTION DRUG FLOMAX TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 19970912 NDA NDA020579 STAT RX USA LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 16590-492_658ce1ae-5e50-40dd-a0e2-534b951e8774 16590-492 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20091124 ANDA ANDA078428 STAT RX USA LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-494_3b3e6adb-2c76-4b95-bb21-a3e059cf479c 16590-494 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 19970625 ANDA ANDA040099 STAT Rx USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 16590-503_8b9f2eb9-27ac-42cb-86bc-f91564bd401d 16590-503 HUMAN PRESCRIPTION DRUG LYRICA PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 STAT Rx USA LLC PREGABALIN 50 mg/1 CV 16590-514_4d23f6be-b21e-4682-b25d-f29ab6c3faa1 16590-514 HUMAN PRESCRIPTION DRUG PAXIL CR PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020409 NDA NDA020936 STAT RX USA LLC PAROXETINE HYDROCHLORIDE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-520_2a1e2e97-66a6-4a25-a5ae-e362077d7450 16590-520 HUMAN PRESCRIPTION DRUG SEROQUEL QUETIAPINE FUMARATE TABLET, FILM COATED ORAL 20110526 NDA NDA020639 STAT RX USA LLC QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 16590-523_0666ee1c-fed4-4f81-93cd-d9d5bdead488 16590-523 HUMAN PRESCRIPTION DRUG SUCRALFATE SUCRALFATE TABLET ORAL 20090701 ANDA ANDA074415 STAT RX USA LLC SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 16590-527_54b44d7d-6cd9-46bf-9eac-cce338407f4f 16590-527 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET ORAL 20070905 ANDA ANDA077903 STAT Rx USA LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 16590-528_54b44d7d-6cd9-46bf-9eac-cce338407f4f 16590-528 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET ORAL 20070905 ANDA ANDA077903 STAT Rx USA LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 16590-539_d3f1f93d-7ea4-4315-a582-819dae7ad3c9 16590-539 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060317 ANDA ANDA077634 STAT Rx USA LLC ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-541_abe5423c-b001-484c-9cf3-c953e16ef526 16590-541 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 STAT RX USA LLC AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 16590-544_60f4d99a-44d9-44ef-a781-3516c3175744 16590-544 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20100429 ANDA ANDA071611 STAT RX USA LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 16590-545_c145392e-45c5-444c-9b97-45154ff3b222 16590-545 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20091027 ANDA ANDA078152 Stat Rx USA ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 16590-556_f108164a-9033-481b-b455-9f7112f4d469 16590-556 HUMAN PRESCRIPTION DRUG PENTAZOCINE HCL AND NALOXONE HCL PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET ORAL 19970121 ANDA ANDA074736 STAT RX USA LLC NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE .5; 50 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIV 16590-579_d81e074d-3674-48d3-b02c-a482516bdc9e 16590-579 HUMAN PRESCRIPTION DRUG BUSPIRONE HCl BUSPIRONE HYDROCHLORIDE TABLET ORAL 20010328 ANDA ANDA074253 STAT RX USA LLC BUSPIRONE HYDROCHLORIDE 15 mg/1 16590-580_036065a2-9754-4781-8d78-6276bb7fb044 16590-580 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED ORAL 19961227 NDA AUTHORIZED GENERIC NDA020504 STAT RX USA LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 16590-581_27e8595c-df30-4b6d-9c68-f85dfff2452e 16590-581 HUMAN PRESCRIPTION DRUG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE PLUS BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET ORAL 20030825 ANDA ANDA040513 STAT RX USA LLC ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 16590-584_08553c0f-22c7-48db-944d-6d42cbe5121b 16590-584 HUMAN PRESCRIPTION DRUG LORAZEPAM LORAZEPAM TABLET ORAL 19911031 ANDA ANDA072927 STAT RX USA LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-585_2741a2e3-3f20-4ecf-87c5-69dbbb62a3d8 16590-585 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19880309 ANDA ANDA071525 STAT RX LLC USA TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 16590-586_f3504a8a-1ddc-4ff4-9533-8e9d1636b7a9 16590-586 HUMAN PRESCRIPTION DRUG DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19880620 ANDA ANDA072103 STAT RX USA LLC DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 16590-588_060234b6-2e60-4edb-adc4-dacb981dda99 16590-588 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ER ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070328 ANDA ANDA077996 STAT RX USA LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-589_04483a13-8925-4d07-bfc2-f7b8dfbf21d9 16590-589 HUMAN PRESCRIPTION DRUG BUDEPRION XL BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20061214 ANDA ANDA077284 STAT RX USA LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 16590-592_dba68081-a390-4be2-b396-d2255e965675 16590-592 HUMAN PRESCRIPTION DRUG VOLTAREN DICLOFENAC SODIUM GEL TOPICAL 20071017 NDA NDA022122 STAT RX USA LLC DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-593_48a580d5-f8b2-4bef-9127-473013b4363f 16590-593 HUMAN PRESCRIPTION DRUG AVINZA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20020320 NDA NDA021260 STAT RX USA LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-594_48a580d5-f8b2-4bef-9127-473013b4363f 16590-594 HUMAN PRESCRIPTION DRUG AVINZA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20020320 NDA NDA021260 STAT RX USA LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-595_48639180-e4a0-49b2-a348-0b4d3fc69151 16590-595 HUMAN PRESCRIPTION DRUG QUALAQUIN QUININE SULFATE CAPSULE ORAL 20050812 NDA NDA021799 STAT RX USA LLC QUININE SULFATE 324 mg/1 Antimalarial [EPC] 16590-596_fd0d5a5f-474c-4be2-a872-abeda6c8cffd 16590-596 HUMAN PRESCRIPTION DRUG Amrix Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071001 NDA NDA021777 STAT RX USA LLC CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 16590-597_48a580d5-f8b2-4bef-9127-473013b4363f 16590-597 HUMAN PRESCRIPTION DRUG AVINZA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20020320 NDA NDA021260 STAT RX USA LLC MORPHINE SULFATE 90 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-598_67b832fa-70b1-4cb4-8b33-fc453939f56a 16590-598 HUMAN PRESCRIPTION DRUG KADIAN MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 STAT RX USA LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-600_c82f9c68-7a7e-43ea-a59a-c88e868ffa27 16590-600 HUMAN PRESCRIPTION DRUG BUSPIRONE BUSPIRONE HYDROCHLORIDE TABLET ORAL 20020301 ANDA ANDA075385 STAT RX USA LLC BUSPIRONE HYDROCHLORIDE 10 mg/1 16590-606_67b832fa-70b1-4cb4-8b33-fc453939f56a 16590-606 HUMAN PRESCRIPTION DRUG KADIAN MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 STAT RX USA LLC MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-609_5711f3ac-bc43-4665-8c13-59b55c8257fd 16590-609 HUMAN PRESCRIPTION DRUG OPANA ER OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060622 NDA NDA021610 STAT RX USA LLC OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-616_c7dd2433-ff31-4423-b3d2-e089fdc1afb5 16590-616 HUMAN PRESCRIPTION DRUG OXYCONTIN OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 STAT Rx USA LLC OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-617_af9fcd68-8239-4c5d-a27f-0526b3c36996 16590-617 HUMAN PRESCRIPTION DRUG OXYCONTIN OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970101 NDA NDA020553 STAT RX USA LLC OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-618_7cf59d3e-8252-41e4-8ccb-a624281e9a02 16590-618 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride and acetaminophen TABLET ORAL 20011130 ANDA ANDA040434 STAT RX USA LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-619_7cf59d3e-8252-41e4-8ccb-a624281e9a02 16590-619 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride and acetaminophen TABLET ORAL 19990630 ANDA ANDA040330 STAT RX USA LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-620_14c3186e-5699-47bd-b053-6e982ef618bd 16590-620 HUMAN PRESCRIPTION DRUG PERCOCET OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET ORAL 19990730 ANDA ANDA040341 STAT RX USA LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 650; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-621_48342591-ea52-43e6-b092-65a21b50e8a2 16590-621 HUMAN PRESCRIPTION DRUG ZYPREXA OLANZAPINE TABLET ORAL 19961001 NDA NDA020592 STAT RX USA LLC OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 16590-622_9fc144cb-399d-4dd0-8e98-76196fb88e44 16590-622 HUMAN PRESCRIPTION DRUG AMITIZA LUBIPROSTONE CAPSULE, GELATIN COATED ORAL 20060131 NDA NDA021908 STAT RX USA LLC LUBIPROSTONE 8 ug/1 Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] 16590-624_9cba94da-ab79-426e-8af1-3bfc0d3d1e9c 16590-624 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20060519 ANDA ANDA088832 STAT RX USA LLC PREDNISONE 10 mg/1 16590-625_cba3264d-0a9e-41be-a8d0-0d6e68f56c81 16590-625 HUMAN PRESCRIPTION DRUG NEXIUM ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE ORAL 20100819 NDA NDA021153 STAT RX USA LLC ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 16590-631_f733e40a-bf95-4cb8-961a-d62e50b17c1b 16590-631 HUMAN PRESCRIPTION DRUG DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE ORAL 20110504 ANDA ANDA070791 STAT Rx USA LLC DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 16590-635_71ad8753-90ea-4d56-9921-c78888b39f28 16590-635 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM DELAYED RELEASE PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20080131 NDA NDA020987 STAT RX USA LLC PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 16590-636_a755a73c-b9c2-4b6f-a5fa-538a3f38e581 16590-636 HUMAN PRESCRIPTION DRUG LORTAB HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 19890825 ANDA ANDA089699 STAT RX USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 16590-641_0e0b2cc2-6987-4ef2-a7a1-78a8e29ff44b 16590-641 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20090101 ANDA ANDA079088 STAT Rx USA LLC RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 16590-642_f1c9424e-e33f-4bad-8c1b-4a850e6f3931 16590-642 HUMAN PRESCRIPTION DRUG PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE TABLET ORAL 19770819 ANDA ANDA085588 STAT RX USA LLC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 16590-643_997a4b60-1b6d-408f-af17-a08509f474dd 16590-643 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET ORAL 20090917 ANDA ANDA078881 STAT RX USA LLC ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 16590-644_338c3466-c532-40cb-b84a-64628e5b69bd 16590-644 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET ORAL 20091127 ANDA ANDA078301 STAT RX USA LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-647_e602474b-d1c1-403b-bc79-ace83092894f 16590-647 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN TABLET, CHEWABLE ORAL 20100128 ANDA ANDA064013 STAT RX USA LLC AMOXICILLIN 125 mg/1 16590-648_714fe0a9-2eb5-49cd-bcb1-fda3f206331c 16590-648 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DR DIVALPROEX SODIUM TABLET, DELAYED RELEASE PARTICLES ORAL 20080729 ANDA ANDA078597 STAT RX USA LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 16590-649_681d195a-a04b-4e02-9577-c44bf48e323e 16590-649 HUMAN PRESCRIPTION DRUG FOCALIN XR DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 STAT RX USA LLC DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 16590-653_c7dd2433-ff31-4423-b3d2-e089fdc1afb5 16590-653 HUMAN PRESCRIPTION DRUG OXYCONTIN OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 STAT Rx USA LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-659_3edeed4f-5ec3-414c-ab86-fbbd5b6d7caf 16590-659 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20070131 ANDA ANDA077712 STAT RX USA LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-660_67b832fa-70b1-4cb4-8b33-fc453939f56a 16590-660 HUMAN PRESCRIPTION DRUG KADIAN MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 STAT RX USA LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-685_198dea39-a961-4bf1-a2c2-2410abae1b51 16590-685 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET ORAL 20090115 ANDA ANDA078858 STAT RX USA LLC LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-689_2e66f507-1d3b-4931-ba2f-003969ac1f2b 16590-689 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 STAT Rx USA LLC METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-693_f1a6f8fd-5084-4574-9af3-682b14dbd605 16590-693 HUMAN PRESCRIPTION DRUG KLONOPIN CLONAZEPAM TABLET ORAL 19750602 NDA NDA017533 STAT RX USA LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-697_67b832fa-70b1-4cb4-8b33-fc453939f56a 16590-697 HUMAN PRESCRIPTION DRUG KADIAN MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 STAT RX USA LLC MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-699_81cb054f-f32a-40c8-91ed-788fa48aca2c 16590-699 HUMAN PRESCRIPTION DRUG FEXMID CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081101 ANDA ANDA071611 STAT Rx USA LLC CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 16590-700_0bb2793e-4ec9-46a1-b450-94f2aa8c28f6 16590-700 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET ORAL 20071218 ANDA ANDA077397 STAT Rx USA LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-724_f979d6cc-a69e-46da-8bf0-93635dca1a6f 16590-724 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060727 ANDA ANDA077636 STAT RX USA LLC ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-727_848dc726-6e17-49e3-9130-967185a8c36c 16590-727 HUMAN PRESCRIPTION DRUG BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET ORAL 20100701 ANDA ANDA075467 STAT RX USA LLC BUSPIRONE HYDROCHLORIDE 7.5 mg/1 16590-734_997a4b60-1b6d-408f-af17-a08509f474dd 16590-734 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET ORAL 20090917 ANDA ANDA078881 STAT RX USA LLC ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 16590-735_199f110d-3d5b-4a99-be74-d6a9a2224ede 16590-735 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 STAT RX USA LLC CIPROFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16590-737_743b60d3-8db7-49f0-a790-7fc0e18c408f 16590-737 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 19960615 ANDA ANDA040156 STAT RX USA LLC HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 16590-740_67b832fa-70b1-4cb4-8b33-fc453939f56a 16590-740 HUMAN PRESCRIPTION DRUG KADIAN MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 STAT RX USA LLC MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-741_f84751bc-927b-4c7e-ad42-22208d8c7422 16590-741 HUMAN PRESCRIPTION DRUG Nizatidine nizatidine CAPSULE ORAL 20100114 ANDA ANDA076178 nizatidine NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 16590-745_d748143d-23e9-412b-8bde-579254958f63 16590-745 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 STAT RX USA LLC ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] 16590-747_5711f3ac-bc43-4665-8c13-59b55c8257fd 16590-747 HUMAN PRESCRIPTION DRUG OPANA ER OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060622 NDA NDA021610 STAT RX USA LLC OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-755_2a907174-11f6-40a3-b040-a290dcc9f690 16590-755 HUMAN PRESCRIPTION DRUG SOMA CARISOPRODOL TABLET ORAL 20070901 NDA NDA011792 STAT RX USA LLC CARISOPRODOL 250 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 16590-756_6c49a00c-10a9-44e3-a2d1-26bc5d194a68 16590-756 HUMAN PRESCRIPTION DRUG ZANAFLEX TIZANIDINE HYDROCHLORIDE CAPSULE ORAL 20020829 NDA NDA021447 STAT RX USA LLC TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 16590-764_f733e40a-bf95-4cb8-961a-d62e50b17c1b 16590-764 HUMAN PRESCRIPTION DRUG DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE ORAL 20110504 ANDA ANDA070791 STAT Rx USA LLC DOXEPIN HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 16590-765_7f72670a-fc54-46af-bd70-cdf99c8b8d00 16590-765 HUMAN PRESCRIPTION DRUG OPANA OXYMORPHONE HYDROCHLORIDE TABLET ORAL 20111215 NDA NDA021611 STAT Rx USA LLC OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-767_5711f3ac-bc43-4665-8c13-59b55c8257fd 16590-767 HUMAN PRESCRIPTION DRUG OPANA ER OXYMORPHONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060622 NDA NDA021610 STAT RX USA LLC OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-774_ec133431-d6da-4ead-b7dc-870a7b1a6b8e 16590-774 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 20091123 NDA AUTHORIZED GENERIC NDA019892 STAT RX USA LLC HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-777_21166684-c909-4f7c-b18b-1b0c9bfda6b9 16590-777 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20101207 ANDA ANDA076388 STAT RX USA LLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 16590-778_67b832fa-70b1-4cb4-8b33-fc453939f56a 16590-778 HUMAN PRESCRIPTION DRUG KADIAN MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 STAT RX USA LLC MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-781_71ebe3c0-9751-4df9-94f0-1c805f674b48 16590-781 HUMAN PRESCRIPTION DRUG LITHIUM CARBONATE LITHIUM CARBONATE TABLET ORAL 19820129 NDA NDA018558 STAT RX USA LLC LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 16590-782_2a1e2e97-66a6-4a25-a5ae-e362077d7450 16590-782 HUMAN PRESCRIPTION DRUG SEROQUEL QUETIAPINE FUMARATE TABLET, FILM COATED ORAL 20110526 NDA NDA020639 STAT RX USA LLC QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 16590-802_21166684-c909-4f7c-b18b-1b0c9bfda6b9 16590-802 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20101207 ANDA ANDA076388 STAT RX USA LLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 16590-808_37a1ed8c-3c52-4863-846a-e6436e215999 16590-808 HUMAN PRESCRIPTION DRUG PROPRANOLOL PROPRANOLOL HYDROCHLORIDE TABLET ORAL 19860101 ANDA ANDA070175 STAT RX USA LLC PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16590-810_fd0d5a5f-474c-4be2-a872-abeda6c8cffd 16590-810 HUMAN PRESCRIPTION DRUG Amrix Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071001 NDA NDA021777 STAT RX USA LLC CYCLOBENZAPRINE HYDROCHLORIDE 30 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 16590-813_f4ba0d9c-b560-4983-addb-528071f99190 16590-813 HUMAN PRESCRIPTION DRUG ATIVAN LORAZEPAM TABLET ORAL 20100316 NDA NDA017794 STAT RX USA LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-815_c4783156-8357-488d-aaf4-83b1e5978529 16590-815 HUMAN PRESCRIPTION DRUG PHENYTOIN ER PHENYTOIN SODIUM CAPSULE ORAL 20091120 ANDA ANDA040298 STAT RX USA LLC PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-817_48c9a615-b275-4531-b34c-fbb8dd4abe2f 16590-817 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET ORAL 20090327 ANDA ANDA079153 STAT Rx USA LLC TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-824_48c9a615-b275-4531-b34c-fbb8dd4abe2f 16590-824 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET ORAL 20090327 ANDA ANDA079153 STAT Rx USA LLC TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-825_48c9a615-b275-4531-b34c-fbb8dd4abe2f 16590-825 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET ORAL 20090327 ANDA ANDA079153 STAT Rx USA LLC TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-827_b35d43ec-75c4-49ad-ba9d-efa009756c35 16590-827 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 20090514 ANDA ANDA078273 STAT RX USA LLC HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-830_f3504a8a-1ddc-4ff4-9533-8e9d1636b7a9 16590-830 HUMAN PRESCRIPTION DRUG DESIPRAMINE HYDROCHLORIDE DESIPRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19880524 ANDA ANDA072099 STAT RX USA LLC DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 16590-832_2d25ddbc-c34c-4c7f-a16a-cc853594c17c 16590-832 HUMAN PRESCRIPTION DRUG GABITRIL TIAGABINE HYDROCHLORIDE TABLET ORAL 19971103 NDA NDA020646 STAT RX USA LLC TIAGABINE HYDROCHLORIDE 12 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-833_fe88f249-3a79-44a7-84a7-1d57a5424bc1 16590-833 HUMAN PRESCRIPTION DRUG LEXAPRO ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 STAT Rx USA LLC ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-835_b390d004-0d08-40c6-b26a-190422f744e7 16590-835 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20090730 ANDA ANDA078206 STAT RX LLC USA OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-837_b6a00f70-c857-4f49-ab4c-623bbe568a90 16590-837 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE METHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 19970829 ANDA ANDA040220 STAT RX USA LLC METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 16590-843_4b46f308-6b50-4d41-b043-b05318be1f90 16590-843 HUMAN PRESCRIPTION DRUG Prozac Fluoxetine hydrochloride CAPSULE ORAL 19871229 NDA NDA018936 Stat Rx USA FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-845_2007f488-af03-4d97-b61c-f51541d117cf 16590-845 HUMAN PRESCRIPTION DRUG SAVELLA MILNACIPRAN HYDROCHLORIDE TABLET, FILM COATED ORAL 20090417 NDA NDA022256 STAT RX USA LLC MILNACIPRAN HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-846_2007f488-af03-4d97-b61c-f51541d117cf 16590-846 HUMAN PRESCRIPTION DRUG SAVELLA MILNACIPRAN HYDROCHLORIDE TABLET, FILM COATED ORAL 20090417 NDA NDA022256 STAT RX USA LLC MILNACIPRAN HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-847_2007f488-af03-4d97-b61c-f51541d117cf 16590-847 HUMAN PRESCRIPTION DRUG SAVELLA MILNACIPRAN HYDROCHLORIDE TABLET, FILM COATED ORAL 20090417 NDA NDA022256 STAT RX USA LLC MILNACIPRAN HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16590-852_24404bb4-860d-409b-8f92-b402439c30b2 16590-852 HUMAN PRESCRIPTION DRUG ALLEGRA-D 24 HOUR FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20041019 NDA NDA021704 STAT RX USA LLC FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180; 240 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 16590-853_b8e15adc-2d1a-43dd-9268-3193848bad79 16590-853 HUMAN PRESCRIPTION DRUG Testim TESTOSTERONE GEL TOPICAL 20021031 NDA NDA021454 Stat Rx USA TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 16590-856_ea287157-86f8-4c9b-87e6-8d08e077d46a 16590-856 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 19980720 ANDA ANDA075028 STAT RX USA LLC PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 16590-859_8cd687d1-975c-426d-8e16-0e2f8c612672 16590-859 HUMAN PRESCRIPTION DRUG EVOXAC CEVIMELINE HYDROCHLORIDE CAPSULE ORAL 20000111 NDA NDA020989 STAT RX USA LLC CEVIMELINE HYDROCHLORIDE 30 mg/1 Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 16590-860_337f5f58-98b3-4ca7-955e-55de770acce1 16590-860 HUMAN PRESCRIPTION DRUG QVAR BECLOMETHASONE DIPROPIONATE AEROSOL, METERED RESPIRATORY (INHALATION) 20000915 NDA NDA020911 STAT RX USA LLC BECLOMETHASONE DIPROPIONATE 40 ug/1 16590-863_5553cf98-1f48-4867-94ee-8ea7544fa331 16590-863 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20090601 NDA NDA022304 Stat Rx USA TAPENTADOL HYDROCHLORIDE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 16590-867_198dea39-a961-4bf1-a2c2-2410abae1b51 16590-867 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET ORAL 20090115 ANDA ANDA078858 STAT RX USA LLC LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-870_b3eec2c8-1981-4343-ba5d-006d615cb092 16590-870 HUMAN PRESCRIPTION DRUG Neurontin Gabapentin CAPSULE ORAL 19931230 NDA NDA020235 STAT RX USA LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16590-871_6c49a00c-10a9-44e3-a2d1-26bc5d194a68 16590-871 HUMAN PRESCRIPTION DRUG ZANAFLEX TIZANIDINE HYDROCHLORIDE CAPSULE ORAL 20020829 NDA NDA021447 STAT RX USA LLC TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 16590-874_e599ec76-b912-441c-b019-3b20f5484c34 16590-874 HUMAN PRESCRIPTION DRUG Darvon-N propoxyphene napsylate TABLET, FILM COATED ORAL 20090925 NDA NDA016862 Stat Rx USA PROPOXYPHENE NAPSYLATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 16590-875_9e349c62-0dcf-43de-a3a1-b1d7350d902a 16590-875 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20000531 ANDA ANDA040358 STAT RX USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 660; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 16590-878_0668cf36-9dcd-428f-9865-b40e52e4e4b4 16590-878 HUMAN PRESCRIPTION DRUG Reprexain Hydrocodone Bitartrate, Ibuprofen TABLET, FILM COATED ORAL 20081216 ANDA ANDA076642 Stat Rx USA HYDROCODONE BITARTRATE; IBUPROFEN 5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 16590-879_03775a4e-ac86-420f-b4b7-7d100049c85d 16590-879 HUMAN PRESCRIPTION DRUG Medrol Methylprednisole TABLET ORAL 19571024 NDA NDA011153 Stat Rx USA METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-881_bc670893-d06a-4c48-bfee-22f4fa87a5d3 16590-881 HUMAN PRESCRIPTION DRUG Avelox ABC Pack MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED ORAL 19991210 NDA NDA021085 Stat Rx USA MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16590-883_05842792-e6da-4a21-a5b3-298453f48e4c 16590-883 HUMAN PRESCRIPTION DRUG BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE SOLUTION/ DROPS OPHTHALMIC 20030528 ANDA ANDA076260 STAT RX USA LLC BRIMONIDINE TARTRATE 2 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 16590-884_1a90cbd5-1392-4823-a36b-443c97e62953 16590-884 HUMAN PRESCRIPTION DRUG MS CONTIN CR MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870701 NDA NDA019516 STAT RX USA LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-885_67b832fa-70b1-4cb4-8b33-fc453939f56a 16590-885 HUMAN PRESCRIPTION DRUG KADIAN MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 STAT RX USA LLC MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-889_7cecfe6b-3bfa-4bfa-93d5-39caa6d142e3 16590-889 HUMAN PRESCRIPTION DRUG NUCYNTA TAPENTADOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20090601 NDA NDA022304 STAT RX USA LLC TAPENTADOL HYDROCHLORIDE 75 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 16590-890_bafb84d3-887a-4e25-a3a2-d10efcd0196f 16590-890 HUMAN PRESCRIPTION DRUG LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED RELEASE ORAL 20091111 NDA AUTHORIZED GENERIC NDA020406 STAT Rx USA LLC LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 16590-891_bafb84d3-887a-4e25-a3a2-d10efcd0196f 16590-891 HUMAN PRESCRIPTION DRUG LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED RELEASE ORAL 20091111 NDA AUTHORIZED GENERIC NDA020406 STAT Rx USA LLC LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 16590-893_94cb364f-3f23-43f4-9fe2-a212ecacab2a 16590-893 HUMAN PRESCRIPTION DRUG Tramadol ER Tramadol ER TABLET, EXTENDED RELEASE ORAL 20091027 ANDA ANDA078783 Stat Rx USA TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 16590-895_018f409d-24cf-408c-bda0-7f11f4f1405d 16590-895 HUMAN PRESCRIPTION DRUG GEODON ZIPRASIDONE HYDROCHLORIDE CAPSULE ORAL 20010205 NDA NDA020825 STAT RX USA LLC ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 16590-897_e2ccd0af-4855-4b8e-834e-aadfb457674a 16590-897 HUMAN PRESCRIPTION DRUG EMBEDA MORPHINE SUFATE CAPSULE, EXTENDED RELEASE ORAL 20090813 NDA NDA022321 STAT RX USA LLC MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 20; .8 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CII 16590-898_2ee3cc8b-3487-433c-ac86-33124e124952 16590-898 HUMAN PRESCRIPTION DRUG MEGESTOL MEGESTROL ACETATE SUSPENSION ORAL 20020215 ANDA ANDA075997 STAT RX USA LLC MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 16590-901_21034760-77dc-493c-b190-d622e8b59cf1 16590-901 HUMAN PRESCRIPTION DRUG DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE TABLET ORAL 20091218 ANDA ANDA040422 STAT RX USA LLC AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 16590-905_13afc5a5-a6d6-42bc-a8f3-24da926747c7 16590-905 HUMAN PRESCRIPTION DRUG CIALIS TADALAFIL TABLET, FILM COATED ORAL 20031126 NDA NDA021368 STAT RX USA LLC TADALAFIL 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 16590-906_e1945d1c-e8f5-408c-a904-430a4234b59b 16590-906 HUMAN PRESCRIPTION DRUG REGLAN METOCLOPRAMIDE HYDROCHLORIDE TABLET ORAL 20100115 NDA NDA017854 STAT RX USA LLC METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 16590-911_a1c4e1d7-6d3c-4d54-b476-b33f5dadc5e5 16590-911 HUMAN PRESCRIPTION DRUG BUTALBITAL, ASPIRIN, AND CAFFEINE BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE ORAL 19760504 NDA AUTHORIZED GENERIC NDA017534 STAT RX USA LLC ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 16590-913_24da0bca-b302-4940-8d34-1269ce70e282 16590-913 HUMAN PRESCRIPTION DRUG Roxicodone oxycodone hydrochloride TABLET ORAL 20000831 NDA NDA021011 STAT RX USA LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-922_13551a6c-64f2-45df-8b41-5c97b2c01421 16590-922 HUMAN PRESCRIPTION DRUG APLENZIN ER BUPROPION HYDROBROMIDE TABLET, EXTENDED RELEASE ORAL 20090330 NDA NDA022108 STAT RX USA LLC BUPROPION HYDROBROMIDE 348 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 16590-925_dbfc942d-8d37-4eac-b7a5-760192ce3976 16590-925 HUMAN PRESCRIPTION DRUG ENDOCET OXYCODONE AND ACETAMINOPHEN TABLET ORAL 20030306 ANDA ANDA040434 STAT RX USA LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-931_66f6d34f-00d3-48b0-9961-c5e2d090f62f 16590-931 HUMAN PRESCRIPTION DRUG OFLOXACIN OFLOXACIN SOLUTION/ DROPS AURICULAR (OTIC) 20080317 ANDA ANDA076616 STAT RX USA LLC OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16590-935_e516bbfe-35f7-4a50-b2ea-31575a324555 16590-935 HUMAN PRESCRIPTION DRUG KLONOPIN CLONAZEPAM TABLET ORAL 19750602 NDA NDA017533 STAT RX USA LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-936_9f62b6d2-6535-4eb5-9bc8-f031e15ef83b 16590-936 HUMAN PRESCRIPTION DRUG SAPHRIS ASENAPINE MALEATE TABLET SUBLINGUAL 20090814 NDA NDA022117 STAT RX USA LLC ASENAPINE MALEATE 10 mg/1 Atypical Antipsychotic [EPC] 16590-937_f4ba0d9c-b560-4983-addb-528071f99190 16590-937 HUMAN PRESCRIPTION DRUG ATIVAN LORAZEPAM TABLET ORAL 20100316 NDA NDA017794 STAT RX USA LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-938_5ea1beea-a65f-49e7-9e79-92c1a41a473e 16590-938 HUMAN PRESCRIPTION DRUG NIRAVAM ALPRAZOLAM TABLET, ORALLY DISINTEGRATING ORAL 20050120 NDA NDA021726 STAT RX USA LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16590-939_fc6d808c-ffc2-4d8a-bc81-92c761ffb9e7 16590-939 HUMAN PRESCRIPTION DRUG PROTONIX DELAYED-RELEASE PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20000501 NDA NDA020987 STAT RX USA LLC PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 16590-942_04f7354d-a6e2-4d9e-98a9-b829d500a799 16590-942 HUMAN PRESCRIPTION DRUG EXALGO HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20110314 NDA NDA021217 STAT Rx USA LLC HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-947_4f2f4e43-bf7a-498a-9367-e0bdaf0cf8da 16590-947 HUMAN PRESCRIPTION DRUG ENDODAN OXYCODONE and ASPIRIN TABLET ORAL 19940520 NDA AUTHORIZED GENERIC NDA007337 STAT RX USA LLC ASPIRIN; OXYCODONE HYDROCHLORIDE 325; 4.8355 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 16590-948_88eb1cc3-a4cb-4460-86b3-2c5ad0d0d6ad 16590-948 HUMAN PRESCRIPTION DRUG NIFEDIPINE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110628 ANDA ANDA090649 STAT RX USA LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 16590-950_4e91211c-e54e-40bd-960e-c6fc149c50f2 16590-950 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE TABLET ORAL 20091117 ANDA ANDA076847 STAT Rx USA LLC SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 16590-952_3b2d1ff4-99d9-4bc2-b2f7-0c1fe9e58f81 16590-952 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET ORAL 20101006 ANDA ANDA090467 STAT Rx USA LLC LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 16590-954_2189324d-2c99-4dbd-bb1e-60827d9eb22c 16590-954 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20101006 ANDA ANDA090528 STAT RX USA LLC HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 16590-957_e335359e-adbf-42c8-b58e-e93424505d7c 16590-957 HUMAN PRESCRIPTION DRUG VIMOVO NAPROXEN AND ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE ORAL 20110701 NDA NDA022511 STAT RX USA LLC ESOMEPRAZOLE MAGNESIUM; NAPROXEN 20; 375 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 16590-959_b9cb0951-aeca-4885-a65d-1969e79cbdd9 16590-959 HUMAN PRESCRIPTION DRUG DETROL TOLTERODINE TARTRATE TABLET, FILM COATED ORAL 19980325 NDA NDA020771 STAT RX USA LLC TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 16590-963_2d89279a-036a-48a7-9560-aeb8a7dcb37d 16590-963 HUMAN PRESCRIPTION DRUG IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE CAPSULE ORAL 20091015 NDA NDA017090 STAT RX USA LLC IMIPRAMINE PAMOATE 75 mg/1 Tricyclic Antidepressant [EPC] 16590-966_fd68f024-2159-4dbb-97d4-21250c4ab65c 16590-966 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 STAT Rx USA LLC MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 16590-977_390d8d63-f378-4962-9329-2f3de24e91ea 16590-977 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20031201 NDA NDA021210 STAT Rx USA LLC LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 16590-981_08072c38-1d7b-4d8b-a5e3-6bc14dbadc64 16590-981 HUMAN PRESCRIPTION DRUG ROBAXIN METHOCARBAMOL TABLET, FILM COATED ORAL 20030120 NDA NDA011011 STAT RX USA LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 16590-984_dc83514f-eac4-489f-b020-584ce4b84ec3 16590-984 HUMAN PRESCRIPTION DRUG ISONIAZID ISONIAZID TABLET ORAL 20101020 ANDA ANDA080937 STAT RX USA LLC ISONIAZID 300 mg/1 Antimycobacterial [EPC] 16590-987_1bb80bde-7c9c-49c1-9721-121b2c7b3f6d 16590-987 HUMAN PRESCRIPTION DRUG TOLMETIN SODIUM TOLMETIN SODIUM TABLET, FILM COATED ORAL 20091102 ANDA ANDA074473 STAT RX USA LLC TOLMETIN SODIUM 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 16590-989_5295317e-d212-42f5-9bed-add0b7a67362 16590-989 HUMAN PRESCRIPTION DRUG BACITRACIN ZINC AND POLYMYXIN B SULFATE BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT OPHTHALMIC 19950130 ANDA ANDA064028 STAT RX USA LLC BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 16590-990_7bb6c15e-f945-4617-b4b7-eb9164021ef2 16590-990 HUMAN PRESCRIPTION DRUG HYDROCORTISONE HYDROCORTISONE TABLET ORAL 19730618 ANDA ANDA083365 STAT RX USA LLC HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16590-992_d23703ad-8b12-49b7-bc5d-7cbd794c481c 16590-992 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET, FILM COATED ORAL 20110813 ANDA ANDA076361 STAT RX USA LLC LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16590-993_2f757638-abbf-4319-8ad3-df77f4a3f50f 16590-993 HUMAN PRESCRIPTION DRUG MOMETASONE FUROATE MOMETASONE FUROATE CREAM TOPICAL 20060823 ANDA ANDA077447 STAT RX USA LLC MOMETASONE FUROATE 1 mg/g 16590-994_181a6f32-ef56-407a-9f06-59c0be15c377 16590-994 HUMAN PRESCRIPTION DRUG LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 STAT RX USA LLC LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16590-998_e90a33f1-b37c-433b-ab0b-15c8c3b28465 16590-998 HUMAN PRESCRIPTION DRUG KETOCONAZOLE KETOCONAZOLE TABLET ORAL 20110531 ANDA ANDA075273 STAT RX USA LLC KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 16714-021_8564d83d-9fba-450e-9152-b64d8461ff09 16714-021 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20091214 ANDA ANDA078213 Northstar RxLLC PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16714-022_8564d83d-9fba-450e-9152-b64d8461ff09 16714-022 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20091214 ANDA ANDA078213 Northstar RxLLC PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16714-023_8564d83d-9fba-450e-9152-b64d8461ff09 16714-023 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20091214 ANDA ANDA078213 Northstar RxLLC PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16714-024_8564d83d-9fba-450e-9152-b64d8461ff09 16714-024 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20091214 ANDA ANDA078213 Northstar RxLLC PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16714-025_8564d83d-9fba-450e-9152-b64d8461ff09 16714-025 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20091214 ANDA ANDA078213 Northstar RxLLC PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16714-031_843054cc-fd21-423c-8b64-e08b61f1de72 16714-031 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20091110 ANDA ANDA078254 Northstar RxLLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16714-032_843054cc-fd21-423c-8b64-e08b61f1de72 16714-032 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20091110 ANDA ANDA078254 Northstar RxLLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16714-033_843054cc-fd21-423c-8b64-e08b61f1de72 16714-033 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20091110 ANDA ANDA078254 Northstar RxLLC ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16714-041_16949f0a-8700-42aa-a96f-c722e859dec4 16714-041 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20091116 ANDA ANDA078253 Northstar RxLLC ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 16714-042_16949f0a-8700-42aa-a96f-c722e859dec4 16714-042 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20091116 ANDA ANDA078253 Northstar RxLLC ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 16714-061_bbb99608-0f7e-41b4-9e38-8ea30ddff0fc 16714-061 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110317 ANDA ANDA078374 Northstar RxLLC METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 16714-062_bbb99608-0f7e-41b4-9e38-8ea30ddff0fc 16714-062 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110317 ANDA ANDA078374 Northstar RxLLC METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 16714-071_eed0120e-e552-4171-a67b-7ea82ff43ebe 16714-071 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20110101 ANDA ANDA078504 Northstar RxLLC BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 16714-072_eed0120e-e552-4171-a67b-7ea82ff43ebe 16714-072 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20110101 ANDA ANDA078401 Northstar RxLLC BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 16714-073_baa3dc62-65f4-487a-9aee-06b1535b5a1b 16714-073 HUMAN PRESCRIPTION DRUG Norethindrone Norethindrone KIT 20130907 ANDA ANDA200961 Northstar Rx LLC 16714-081_b93eff3f-0664-4850-8521-a0ae4dab6a6a 16714-081 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride HydrOXYzine Hydrochloride TABLET ORAL 20091111 ANDA ANDA040841 Northstar RxLLC HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 16714-082_b93eff3f-0664-4850-8521-a0ae4dab6a6a 16714-082 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride HydrOXYzine Hydrochloride TABLET ORAL 20091111 ANDA ANDA040842 Northstar RxLLC HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 16714-083_b93eff3f-0664-4850-8521-a0ae4dab6a6a 16714-083 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride HydrOXYzine Hydrochloride TABLET ORAL 20091111 ANDA ANDA040840 Northstar RxLLC HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 16714-101_f615c2c6-ca1f-4d62-81ce-37643117a305 16714-101 HUMAN PRESCRIPTION DRUG Gemfibrozil gemfibrozil TABLET ORAL 20101220 ANDA ANDA079072 Northstar RxLLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 16714-111_aeba85c9-7d75-4098-9fec-d4dc08ed6809 16714-111 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20110216 ANDA ANDA078935 Northstar RxLLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 16714-202_3232f7b1-fe68-49bd-9c93-14e30ea3743f 16714-202 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20071107 20150501 ANDA ANDA065307 Northstar Rx LLC CEFADROXIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16714-203_3232f7b1-fe68-49bd-9c93-14e30ea3743f 16714-203 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20071119 20150501 ANDA ANDA065307 Northstar Rx LLC CEFADROXIL 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16714-221_507db165-4fda-4fc7-8f78-f14a27490ef0 16714-221 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride TABLET, FILM COATED ORAL 20080429 ANDA ANDA078678 Northstar Rx LLC GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 16714-221_efdb1370-c249-42ee-acac-0254fba4e376 16714-221 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride TABLET, FILM COATED ORAL 20080429 ANDA ANDA078678 Northstar Rx LLC GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 16714-224_e573d7b6-bff4-497f-ab08-1a975260fcb6 16714-224 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 NorthStar Rx LLC HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 16714-225_e573d7b6-bff4-497f-ab08-1a975260fcb6 16714-225 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 NorthStar Rx LLC HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 16714-226_e573d7b6-bff4-497f-ab08-1a975260fcb6 16714-226 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 NorthStar Rx LLC HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 16714-234_7bd212ca-9474-43ed-8ed6-956b98654331 16714-234 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 NorthStar Rx LLC PENICILLIN V POTASSIUM 250 mg/1 16714-235_7bd212ca-9474-43ed-8ed6-956b98654331 16714-235 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 NorthStar Rx LLC PENICILLIN V POTASSIUM 500 mg/1 16714-271_67d0d079-faee-47d4-a2eb-7817783c345b 16714-271 HUMAN OTC DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20091019 ANDA ANDA078862 Northstar Rx LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 16714-292_4b670957-99ee-4fad-87ee-5fd8e0f01d9e 16714-292 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 NorthStar Rx LLC AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 16714-293_4b670957-99ee-4fad-87ee-5fd8e0f01d9e 16714-293 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 NorthStar Rx LLC AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 16714-294_7077443d-2391-405c-95c0-e6680c76b587 16714-294 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201091 NorthStar Rx LLC AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 16714-295_ec0ea414-84e6-4669-9165-5498ac728e15 16714-295 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091569 NorthStar Rx LLC AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 16714-296_ec0ea414-84e6-4669-9165-5498ac728e15 16714-296 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091569 NorthStar Rx LLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 16714-297_ec0ea414-84e6-4669-9165-5498ac728e15 16714-297 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091568 NorthStar Rx LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 16714-298_d1b87a75-95a5-4662-b45c-174d7b263c91 16714-298 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 NorthStar Rx LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 16714-299_d1b87a75-95a5-4662-b45c-174d7b263c91 16714-299 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 NorthStar Rx LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 16714-300_0824f926-5508-4ad0-9014-3501f6f74d06 16714-300 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA091114 NorthStar Rx LLC FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 16714-304_0824f926-5508-4ad0-9014-3501f6f74d06 16714-304 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA091114 NorthStar Rx LLC FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 16714-305_0824f926-5508-4ad0-9014-3501f6f74d06 16714-305 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA091114 NorthStar Rx LLC FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 16714-311_3a8f8440-f033-4a2c-aa23-84482f9b9eae 16714-311 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20101221 ANDA ANDA078932 NorthStar RxLLC VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16714-312_3a8f8440-f033-4a2c-aa23-84482f9b9eae 16714-312 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20101221 ANDA ANDA078932 NorthStar RxLLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16714-313_3a8f8440-f033-4a2c-aa23-84482f9b9eae 16714-313 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20101221 ANDA ANDA078932 NorthStar RxLLC VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16714-314_3a8f8440-f033-4a2c-aa23-84482f9b9eae 16714-314 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20101221 ANDA ANDA078932 NorthStar RxLLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16714-315_3a8f8440-f033-4a2c-aa23-84482f9b9eae 16714-315 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20101221 ANDA ANDA078932 NorthStar RxLLC VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16714-321_cece7c0f-bc65-4d68-8df7-86faf545ddd2 16714-321 HUMAN PRESCRIPTION DRUG Leflunomide leflunomide TABLET ORAL 20110506 ANDA ANDA091369 NorthStar RxLLC LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] 16714-330_4d934abf-47af-490b-8aeb-e69070d15305 16714-330 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111006 ANDA ANDA200651 NorthStar Rx LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16714-331_cece7c0f-bc65-4d68-8df7-86faf545ddd2 16714-331 HUMAN PRESCRIPTION DRUG Leflunomide leflunomide TABLET ORAL 20110506 ANDA ANDA091369 NorthStar RxLLC LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] 16714-332_4d934abf-47af-490b-8aeb-e69070d15305 16714-332 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111006 ANDA ANDA200651 NorthStar Rx LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16714-334_65697681-5eab-49d6-ba9c-4f75a1c6a8c8 16714-334 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (SR) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120501 ANDA ANDA077455 NorthStar RX LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 16714-335_65697681-5eab-49d6-ba9c-4f75a1c6a8c8 16714-335 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120501 ANDA ANDA077455 NorthStar RX LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 16714-336_65697681-5eab-49d6-ba9c-4f75a1c6a8c8 16714-336 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120501 ANDA ANDA077455 NorthStar RX LLC BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 16714-338_10c294ad-06ec-4c7d-9439-e7d8703b2c2f 16714-338 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil citrate TABLET, FILM COATED ORAL 20130226 ANDA ANDA202503 Northstar RxLLC SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 16714-339_eb25ecc8-5989-48c7-847e-e51f942a82ff 16714-339 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET, FILM COATED ORAL 20130116 ANDA ANDA078357 Northstar Rx LLC DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 16714-340_cfa5e47b-5d28-4dca-8706-70ac9b5c93d9 16714-340 HUMAN PRESCRIPTION DRUG LEVONEST Levonorgestrel and Ethinyl Estradiol KIT ORAL 20120601 ANDA ANDA090719 Northstar Rx LLC 16714-341_c6980ac7-840b-4fe0-b0cc-82cee2d69e9a 16714-341 HUMAN PRESCRIPTION DRUG clonidine hydrochloride Clonidine Hydrochloride TABLET ORAL 20130204 ANDA ANDA091368 NorthStar RxLLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 16714-342_c6980ac7-840b-4fe0-b0cc-82cee2d69e9a 16714-342 HUMAN PRESCRIPTION DRUG clonidine hydrochloride Clonidine Hydrochloride TABLET ORAL 20130204 ANDA ANDA091368 NorthStar RxLLC CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 16714-343_c6980ac7-840b-4fe0-b0cc-82cee2d69e9a 16714-343 HUMAN PRESCRIPTION DRUG clonidine hydrochloride Clonidine Hydrochloride TABLET ORAL 20130204 ANDA ANDA091368 NorthStar RxLLC CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 16714-346_a66e4edb-b03d-4c3d-8a44-ed404bde7d2f 16714-346 HUMAN PRESCRIPTION DRUG Dasetta 7/7/7 Norethindrone and Ethinyl Estradiol KIT ORAL 20120601 ANDA ANDA090946 Northstar Rx LLC 16714-347_cdd9038b-35a6-43a4-b425-835d3fe86282 16714-347 HUMAN PRESCRIPTION DRUG PHILITH Norethindrone and Ethinyl Estradiol Tablets KIT ORAL 20120601 ANDA ANDA090947 Northstar Rx LLC 16714-348_efac4b53-aefb-41f3-96ea-0763b6b04628 16714-348 HUMAN PRESCRIPTION DRUG Dasetta 1/35 Norethindrone and Ethinyl Estradiol KIT ORAL 20120601 ANDA ANDA090948 Northstar Rx LLC 16714-351_a85acb24-83e0-4dd2-80ed-b4cf9a43f4ac 16714-351 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20090701 ANDA ANDA090223 NorthStar RxLLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16714-352_a85acb24-83e0-4dd2-80ed-b4cf9a43f4ac 16714-352 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20090701 ANDA ANDA090223 NorthStar RxLLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16714-353_a85acb24-83e0-4dd2-80ed-b4cf9a43f4ac 16714-353 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20090701 ANDA ANDA090223 NorthStar RxLLC FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16714-354_f2aa034c-4524-4a86-8025-8aaa8ae27593 16714-354 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 NorthStar Rx LLC LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16714-355_f2aa034c-4524-4a86-8025-8aaa8ae27593 16714-355 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 NorthStar Rx LLC LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16714-356_f2aa034c-4524-4a86-8025-8aaa8ae27593 16714-356 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 NorthStar Rx LLC LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16714-357_f2aa034c-4524-4a86-8025-8aaa8ae27593 16714-357 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 NorthStar Rx LLC LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16714-358_e4417ed7-11a4-4d8f-b8b5-ba3087a4f1cc 16714-358 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090115 ANDA ANDA079063 NorthStar Rx LLC LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16714-359_aec25b09-f7ad-4b2a-9676-332b8344a459 16714-359 HUMAN PRESCRIPTION DRUG FALMINA Levonorgestrel and Ethinyl Estradiol KIT ORAL 20120701 ANDA ANDA090721 Northstar Rx LLC 16714-360_a6a58d0c-3d47-450b-9ba2-9f6f5a7fe452 16714-360 HUMAN PRESCRIPTION DRUG MONO-LINYAH Norgestimate and Ethinyl Estradiol KIT ORAL 20120801 ANDA ANDA090523 Northstar Rx LLC 16714-361_6a5dc416-4ad7-4ca5-9518-3b032547d4fe 16714-361 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20090701 ANDA ANDA078916 NorthStar RxLLC FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 16714-362_6a5dc416-4ad7-4ca5-9518-3b032547d4fe 16714-362 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20090701 ANDA ANDA078916 NorthStar RxLLC FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 16714-363_d086c062-779a-4005-b9e3-1cb76ad7284a 16714-363 HUMAN PRESCRIPTION DRUG TRI-LINYAH Norgestimate and Ethinyl Estradiol KIT ORAL 20140530 ANDA ANDA090524 Northstar Rx LLC 16714-365_f64a9524-595d-4c9b-b3ee-192127d2a485 16714-365 HUMAN PRESCRIPTION DRUG ELINEST Norgestrel and Ethinyl Estradiol KIT ORAL 20120701 ANDA ANDA091105 Northstar Rx LLC 16714-367_bb80f02e-e555-486e-b941-a1f1a9279186 16714-367 HUMAN PRESCRIPTION DRUG Desogestrel and Ethinyl Estradiol Desogestrel and Ethinyl Estradiol KIT 20140530 ANDA ANDA091234 Northstar Rx LLC 16714-370_a9d782e2-e441-4850-a6ee-353b2ecd622c 16714-370 HUMAN PRESCRIPTION DRUG WERA Norethindrone and Ethinyl Estradiol KIT ORAL 20120601 ANDA ANDA091204 Northstar Rx LLC 16714-371_9d1474cc-1ed6-4102-adc0-d8e1295c1980 16714-371 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130101 ANDA ANDA090607 NorthStar RxLLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 16714-372_9d1474cc-1ed6-4102-adc0-d8e1295c1980 16714-372 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130101 ANDA ANDA090607 NorthStar RxLLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 16714-373_9d1474cc-1ed6-4102-adc0-d8e1295c1980 16714-373 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130101 ANDA ANDA090607 NorthStar RxLLC LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 16714-374_9d1474cc-1ed6-4102-adc0-d8e1295c1980 16714-374 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130101 ANDA ANDA090607 NorthStar RxLLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 16714-375_2e575730-5780-43b5-8506-baadd9d08b9a 16714-375 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 NorthStar Rx LLC QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 16714-376_2e575730-5780-43b5-8506-baadd9d08b9a 16714-376 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 NorthStar Rx LLC QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 16714-377_2e575730-5780-43b5-8506-baadd9d08b9a 16714-377 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 NorthStar Rx LLC QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 16714-378_2e575730-5780-43b5-8506-baadd9d08b9a 16714-378 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 NorthStar Rx LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 16714-379_2e575730-5780-43b5-8506-baadd9d08b9a 16714-379 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 NorthStar Rx LLC QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 16714-380_2e575730-5780-43b5-8506-baadd9d08b9a 16714-380 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 NorthStar Rx LLC QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 16714-383_19e5be87-a984-4590-94e9-e7135e5e14ba 16714-383 HUMAN PRESCRIPTION DRUG hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20101217 ANDA ANDA200645 NorthStar RxLLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 16714-384_35ce979e-4df4-4de6-8122-c641794d2c3c 16714-384 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride 5 mg Donepezil Hydrochloride TABLET, FILM COATED ORAL 20130304 ANDA ANDA201724 NorthStar RxLLC DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 16714-385_35ce979e-4df4-4de6-8122-c641794d2c3c 16714-385 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride 10 mg Donepezil Hydrochloride TABLET, FILM COATED ORAL 20130219 ANDA ANDA201724 NorthStar RxLLC DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 16714-386_8444fd58-817d-439e-8ee8-d6b16c4ae0dd 16714-386 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20120930 ANDA ANDA065284 NorthStar Rx LLC CEFPROZIL 125 mg/5mL 16714-387_8444fd58-817d-439e-8ee8-d6b16c4ae0dd 16714-387 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20120930 ANDA ANDA065284 NorthStar Rx LLC CEFPROZIL 250 mg/5mL 16714-388_2961d11e-20e3-447f-8b03-6a479af7bd8a 16714-388 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20070125 ANDA ANDA065352 NorthStar Rx LLC CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16714-389_63ddad42-d307-4da8-9b0b-19bec6de83eb 16714-389 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20130425 ANDA ANDA065349 NorthStar Rx LLC CEFADROXIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16714-390_63ddad42-d307-4da8-9b0b-19bec6de83eb 16714-390 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20130425 ANDA ANDA065349 NorthStar Rx LLC CEFADROXIL 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16714-391_831f04e4-4566-49f8-9552-2378307a10c8 16714-391 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20080107 ANDA ANDA065434 NorthStar Rx LLC CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16714-392_e49b6477-4c64-41a5-b3a3-37461757a6fd 16714-392 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20071214 ANDA ANDA065473 NorthStar Rx LLC CEFDINIR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16714-393_e49b6477-4c64-41a5-b3a3-37461757a6fd 16714-393 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20071214 ANDA ANDA065473 NorthStar Rx LLC CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16714-394_622e20a9-4a3b-4a09-a68f-630fd08eea49 16714-394 HUMAN PRESCRIPTION DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED ORAL 20070611 ANDA ANDA065370 NorthStar Rx LLC CEFPODOXIME PROXETIL 100 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16714-395_622e20a9-4a3b-4a09-a68f-630fd08eea49 16714-395 HUMAN PRESCRIPTION DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED ORAL 20070611 ANDA ANDA065370 NorthStar Rx LLC CEFPODOXIME PROXETIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16714-396_8e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4 16714-396 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20070130 ANDA ANDA065381 NorthStar Rx LLC CEFPROZIL 125 mg/5mL 16714-397_8e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4 16714-397 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20070130 ANDA ANDA065381 NorthStar Rx LLC CEFPROZIL 250 mg/5mL 16714-398_6133611e-19c1-4df2-8c23-8573aaf63020 16714-398 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20070524 ANDA ANDA065340 NorthStar Rx LLC CEFPROZIL 250 mg/1 16714-399_6133611e-19c1-4df2-8c23-8573aaf63020 16714-399 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20070524 ANDA ANDA065340 NorthStar Rx LLC CEFPROZIL 500 mg/1 16714-400_b28a5e88-6593-4b8f-95ad-ff096e8478ae 16714-400 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 NorthStar Rx LLC CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16714-401_b28a5e88-6593-4b8f-95ad-ff096e8478ae 16714-401 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 NorthStar Rx LLC CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16714-402_504422f8-3d4f-4063-9b48-c9e6e85422bc 16714-402 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil GRANULE, FOR SUSPENSION ORAL 20070608 ANDA ANDA065409 NorthStar Rx LLC CEFPODOXIME PROXETIL 50 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16714-403_504422f8-3d4f-4063-9b48-c9e6e85422bc 16714-403 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil GRANULE, FOR SUSPENSION ORAL 20070608 ANDA ANDA065409 NorthStar Rx LLC CEFPODOXIME PROXETIL 100 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 16714-404_eba6acf6-de57-4745-b855-2e3caf49e352 16714-404 HUMAN PRESCRIPTION DRUG PIMTREA Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol KIT 20130801 ANDA ANDA091247 Northstar Rx LLC 16714-405_e0eef6c9-a02b-4ad7-ba13-60cf07f591e0 16714-405 HUMAN PRESCRIPTION DRUG LARIN Fe 1.5/30 Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate KIT 20130823 ANDA ANDA091453 Northstar Rx LLC 16714-406_e796b23d-ba7c-4a1a-8ef9-8c7476dd6645 16714-406 HUMAN PRESCRIPTION DRUG LARIN Fe 1/20 Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate KIT 20130901 ANDA ANDA091454 Northstar Rx LLC 16714-407_faee632f-b068-45fe-9a2c-10bddb159c0c 16714-407 HUMAN PRESCRIPTION DRUG LARIN 1.5/30 Norethindrone Acetate/Ethinyl Estradiol KIT 20140501 ANDA ANDA202996 Northstar Rx LLC 16714-408_b4ebe264-90ad-4d79-b077-80c5e69aa65e 16714-408 HUMAN PRESCRIPTION DRUG LARIN 1/20 Norethindrone Acetate/Ethinyl Estradiol KIT 20140106 ANDA ANDA202995 Northstar Rx LLC 16714-413_f7fd1680-b0c7-4e2b-9726-de253a96a2d9 16714-413 HUMAN PRESCRIPTION DRUG Norethindrone Norethindrone KIT 20130910 ANDA ANDA202014 Northstar Rx LLC 16714-417_ff0239c9-dacb-4f86-8ad8-7f1a01432227 16714-417 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide 50 mg-25 mg Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20130917 ANDA ANDA202870 NorthStar RxLLC HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 16714-418_ff0239c9-dacb-4f86-8ad8-7f1a01432227 16714-418 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide 100 mg-25 mg Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20130917 ANDA ANDA202870 NorthStar RxLLC HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25; 100 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 16714-419_ff0239c9-dacb-4f86-8ad8-7f1a01432227 16714-419 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide 100 mg-50 mg Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20130917 ANDA ANDA202870 NorthStar RxLLC HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 50; 100 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 16714-420_84092e26-b791-423d-b4ff-58ad16ec35dc 16714-420 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride 20 mg Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140609 ANDA ANDA202949 NorthStar RxLLC DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16714-421_84092e26-b791-423d-b4ff-58ad16ec35dc 16714-421 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride 30 mg Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140609 ANDA ANDA202949 NorthStar RxLLC DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16714-422_84092e26-b791-423d-b4ff-58ad16ec35dc 16714-422 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride 20 mg Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140609 ANDA ANDA202949 NorthStar RxLLC DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16714-439_d0dbfce6-d5ea-41d8-b568-c021bc77457b 16714-439 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin (monohydrate/macrocrystals) CAPSULE ORAL 20141101 ANDA ANDA077066 Northstar RxLLC NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 16714-440_b73a79d3-87d6-4055-ab77-f61e70b17a06 16714-440 HUMAN PRESCRIPTION DRUG DEBLITANE Norethindrone KIT 20140601 ANDA ANDA202014 Northstar Rx LLC 16714-441_a7639d5e-4fe1-4f4f-a962-658ba7370350 16714-441 HUMAN PRESCRIPTION DRUG SHAROBEL Norethindrone KIT 20140601 ANDA ANDA200961 Northstar Rx LLC 16714-446_23521590-ec42-4845-aab4-600f6b79e084 16714-446 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20141201 ANDA ANDA085969 Northstar RxLLC AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 16714-447_23521590-ec42-4845-aab4-600f6b79e084 16714-447 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20141201 ANDA ANDA085966 Northstar RxLLC AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 16714-448_23521590-ec42-4845-aab4-600f6b79e084 16714-448 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20141201 ANDA ANDA085968 Northstar RxLLC AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 16714-449_23521590-ec42-4845-aab4-600f6b79e084 16714-449 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20141201 ANDA ANDA085971 Northstar RxLLC AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 16714-450_23521590-ec42-4845-aab4-600f6b79e084 16714-450 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20141201 ANDA ANDA085967 Northstar RxLLC AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 16714-451_23521590-ec42-4845-aab4-600f6b79e084 16714-451 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20141201 ANDA ANDA085970 Northstar RxLLC AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 16714-501_be543951-cc78-49e1-a84d-aea0604b45f2 16714-501 HUMAN PRESCRIPTION DRUG terbinafine hydrochloride terbinafine hydrochloride TABLET ORAL 20090915 ANDA ANDA078163 Northstar Rx LLC TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 16714-522_4c303c07-ddee-43bf-a277-d40e7ef724c5 16714-522 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20110516 ANDA ANDA077914 NorthStar Rx LLC FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 16714-522_c08029db-9dcc-4393-985a-b7251962d1f7 16714-522 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20110302 ANDA ANDA077914 NorthStar Rx LLC FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 16714-531_528c3cff-431b-4f31-87f4-3c608e2c08a1 16714-531 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan TABLET, FILM COATED ORAL 20110103 ANDA ANDA078284 Northstar Rx LLC SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 16714-532_528c3cff-431b-4f31-87f4-3c608e2c08a1 16714-532 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan TABLET, FILM COATED ORAL 20110103 ANDA ANDA078284 Northstar Rx LLC SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 16714-533_528c3cff-431b-4f31-87f4-3c608e2c08a1 16714-533 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan TABLET, FILM COATED ORAL 20110103 ANDA ANDA078284 Northstar Rx LLC SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 16714-551_1808aabd-2c97-49a0-996c-45a6f3d2c216 16714-551 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20100623 ANDA ANDA090374 Northstar Rx LLC ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 16714-561_1808aabd-2c97-49a0-996c-45a6f3d2c216 16714-561 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20100623 ANDA ANDA090374 Northstar Rx LLC ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 16714-571_08a480d1-3047-4598-b9f8-41c4e104181c 16714-571 HUMAN PRESCRIPTION DRUG Bicalutamide bicalutamide TABLET, FILM COATED ORAL 20090828 ANDA ANDA078634 Northstar Rx LLC BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 16714-581_89ac0645-a020-48b9-84af-e91570b84743 16714-581 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090382 NorthStar Rx LLC LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 16714-582_89ac0645-a020-48b9-84af-e91570b84743 16714-582 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090382 NorthStar Rx LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 16714-583_89ac0645-a020-48b9-84af-e91570b84743 16714-583 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090382 NorthStar Rx LLC LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 16714-584_4478eeea-399a-41b1-a7fe-247950b1c691 16714-584 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101130 ANDA ANDA091254 Northstar Rx LLC PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 16714-585_4478eeea-399a-41b1-a7fe-247950b1c691 16714-585 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101130 ANDA ANDA091254 Northstar Rx LLC PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 16714-586_4478eeea-399a-41b1-a7fe-247950b1c691 16714-586 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101130 ANDA ANDA091254 Northstar Rx LLC PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 16714-587_4478eeea-399a-41b1-a7fe-247950b1c691 16714-587 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101130 ANDA ANDA091254 Northstar Rx LLC PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 16714-588_4478eeea-399a-41b1-a7fe-247950b1c691 16714-588 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101130 ANDA ANDA091254 Northstar Rx LLC PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 16714-589_4478eeea-399a-41b1-a7fe-247950b1c691 16714-589 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101130 ANDA ANDA091254 Northstar Rx LLC PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 16714-601_0473bfe7-83af-4e3d-a2c6-d697a7b7c4c8 16714-601 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride SOLUTION ORAL 20081031 ANDA ANDA078861 NorthStar Rx LLC SERTRALINE HYDROCHLORIDE 20 mg/mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16714-611_4e116517-d680-4bad-94a0-6b0664526c3b 16714-611 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 NorthStar Rx LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16714-612_4e116517-d680-4bad-94a0-6b0664526c3b 16714-612 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 NorthStar Rx LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16714-613_4e116517-d680-4bad-94a0-6b0664526c3b 16714-613 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 NorthStar Rx LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16714-621_7acec78a-4d62-42dd-9836-3e3099d509af 16714-621 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070504 ANDA ANDA078413 NorthStar Rx LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 16714-622_7acec78a-4d62-42dd-9836-3e3099d509af 16714-622 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070504 ANDA ANDA078413 NorthStar Rx LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 16714-631_9db9f738-dbe4-4af2-99d6-4a89b33fbb87 16714-631 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA090124 NorthStar Rx LLC ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 16714-632_9db9f738-dbe4-4af2-99d6-4a89b33fbb87 16714-632 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA090124 NorthStar Rx LLC ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 16714-633_9db9f738-dbe4-4af2-99d6-4a89b33fbb87 16714-633 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA090124 NorthStar Rx LLC ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 16714-651_0d6090fe-2c4b-4ec6-a77c-d6e3bd327b1c 16714-651 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 NorthStar Rx LLC CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16714-652_0d6090fe-2c4b-4ec6-a77c-d6e3bd327b1c 16714-652 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 NorthStar Rx LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16714-653_0d6090fe-2c4b-4ec6-a77c-d6e3bd327b1c 16714-653 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 NorthStar Rx LLC CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 16714-661_bd05fd65-1081-4a84-955a-9e66e88fc9e1 16714-661 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 NorthStar Rx LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16714-662_bd05fd65-1081-4a84-955a-9e66e88fc9e1 16714-662 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 NorthStar Rx LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16714-663_bd05fd65-1081-4a84-955a-9e66e88fc9e1 16714-663 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 NorthStar Rx LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16714-671_557490ee-dcf3-4ac5-a3d7-60dd90db3b14 16714-671 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride SOLUTION ORAL 20071128 ANDA ANDA078776 NorthStar Rx LLC ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 16714-681_d41f0113-4b12-44d3-80e3-47ddd8c87659 16714-681 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NorthStar Rx LLC SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16714-682_d41f0113-4b12-44d3-80e3-47ddd8c87659 16714-682 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NorthStar Rx LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16714-683_d41f0113-4b12-44d3-80e3-47ddd8c87659 16714-683 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NorthStar Rx LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16714-684_d41f0113-4b12-44d3-80e3-47ddd8c87659 16714-684 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NorthStar Rx LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16714-685_d41f0113-4b12-44d3-80e3-47ddd8c87659 16714-685 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NorthStar Rx LLC SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16714-691_1d823e22-7b8a-434f-9fad-1bdec095ea81 16714-691 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 NorthStar Rx LLC FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 16714-692_1d823e22-7b8a-434f-9fad-1bdec095ea81 16714-692 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 NorthStar Rx LLC FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 16714-693_1d823e22-7b8a-434f-9fad-1bdec095ea81 16714-693 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 NorthStar Rx LLC FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 16714-694_1d823e22-7b8a-434f-9fad-1bdec095ea81 16714-694 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 NorthStar Rx LLC FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 16714-695_ff4861a0-49b9-4cc1-a090-da5cf23064ba 16714-695 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20090918 ANDA ANDA079150 NorthStar Rx LLC FLUCONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 16714-696_ff4861a0-49b9-4cc1-a090-da5cf23064ba 16714-696 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20090918 ANDA ANDA079150 NorthStar Rx LLC FLUCONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 16714-697_ee3f2653-9e3e-4234-b88a-0fd3e03bcb20 16714-697 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 NorthStar Rx LLC VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 16714-698_ee3f2653-9e3e-4234-b88a-0fd3e03bcb20 16714-698 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 NorthStar Rx LLC VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 16729-001_976d77bc-201c-4797-897f-e1c4462997b2 16729-001 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Accord Healthcare Inc GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 16729-002_976d77bc-201c-4797-897f-e1c4462997b2 16729-002 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Accord Healthcare Inc GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 16729-003_976d77bc-201c-4797-897f-e1c4462997b2 16729-003 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Accord Healthcare Inc GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 16729-004_0579a12e-6919-3fa0-e054-00144ff88e88 16729-004 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Accord Healthcare, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16729-005_0579a12e-6919-3fa0-e054-00144ff88e88 16729-005 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Accord Healthcare, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16729-006_0579a12e-6919-3fa0-e054-00144ff88e88 16729-006 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Accord Healthcare, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16729-007_0579a12e-6919-3fa0-e054-00144ff88e88 16729-007 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Accord Healthcare, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16729-019_2008a4a6-2d32-4e72-a587-8572d7559519 16729-019 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET ORAL 20090504 ANDA ANDA065416 Accord Healthcare Inc. MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 16729-020_3fa16c19-b547-4586-9808-00208b56982e 16729-020 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA200044 Accord Healthcare Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 16729-021_3fa16c19-b547-4586-9808-00208b56982e 16729-021 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA200044 Accord Healthcare Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 16729-022_3fa16c19-b547-4586-9808-00208b56982e 16729-022 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA200044 Accord Healthcare Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 16729-023_7c295b64-ec39-42ec-9f02-da5b42e775e1 16729-023 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET ORAL 20090706 ANDA ANDA078917 Accord Healthcare Inc BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 16729-029_00206aae-7db1-4ae9-8500-b03fd6788d74 16729-029 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 20120627 ANDA ANDA070070 Accord Healthcare Inc. METHYLDOPA 125 mg/1 16729-030_00206aae-7db1-4ae9-8500-b03fd6788d74 16729-030 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 20120627 ANDA ANDA070084 Accord Healthcare Inc. METHYLDOPA 250 mg/1 16729-031_00206aae-7db1-4ae9-8500-b03fd6788d74 16729-031 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 20120627 ANDA ANDA070085 Accord Healthcare Inc. METHYLDOPA 500 mg/1 16729-034_94bdfa65-d1a7-4e70-a94a-ed157687b0c9 16729-034 HUMAN PRESCRIPTION DRUG Letrozole letrozole TABLET, FILM COATED ORAL 20110603 ANDA ANDA090934 Accord Healthcare, Inc. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 16729-035_04fbd137-8e73-04e9-e054-00144ff8d46c 16729-035 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100628 ANDA ANDA090568 Accord Healthcare Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 16729-041_05df8415-c683-2a49-e054-00144ff8d46c 16729-041 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20110831 ANDA ANDA091195 Accord Healthcare Inc. TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 16729-042_05df8415-c683-2a49-e054-00144ff8d46c 16729-042 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20110831 ANDA ANDA091195 Accord Healthcare Inc. TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 16729-043_05df8415-c683-2a49-e054-00144ff8d46c 16729-043 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20110831 ANDA ANDA091195 Accord Healthcare Inc. TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 16729-064_546dd170-2b0f-4224-9a56-9a0dbe49c48b 16729-064 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20110314 ANDA ANDA090843 Accord Healthcare Inc. LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16729-065_546dd170-2b0f-4224-9a56-9a0dbe49c48b 16729-065 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20110314 ANDA ANDA090843 Accord Healthcare Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16729-066_546dd170-2b0f-4224-9a56-9a0dbe49c48b 16729-066 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20110314 ANDA ANDA090843 Accord Healthcare Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16729-067_546dd170-2b0f-4224-9a56-9a0dbe49c48b 16729-067 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20110314 ANDA ANDA090843 Accord Healthcare Inc. LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 16729-078_f54d043d-1898-4834-925a-d19cd9cee2e4 16729-078 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20130509 ANDA ANDA202323 Accord Healthcare, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 16729-079_f54d043d-1898-4834-925a-d19cd9cee2e4 16729-079 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20130509 ANDA ANDA202323 Accord Healthcare, Inc. CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 16729-081_05238e96-8d7f-616a-e054-00144ff8d46c 16729-081 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 20111001 ANDA ANDA091205 Accord Healthcare, Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] 16729-089_e055e9af-1b78-4acd-971e-a3a2cec6a8d5 16729-089 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20131105 ANDA ANDA091643 Accord Healthcare, Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 16729-090_80e922ee-ab28-488c-9c73-2819038aaee8 16729-090 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20100511 ANDA ANDA090121 Accord Healthcare, Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 16729-092_642ad9b5-fc42-4f81-a05b-2b6607a95590 16729-092 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA091594 Accord Healthcare Inc. GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 16729-094_2008a4a6-2d32-4e72-a587-8572d7559519 16729-094 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20090504 ANDA ANDA090253 Accord Healthcare Inc. MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 16729-108_0a4ea340-dcd4-2b02-e054-00144ff88e88 16729-108 HUMAN PRESCRIPTION DRUG Mitomycin Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090610 ANDA ANDA064144 Accord Healthcare Inc MITOMYCIN 20 mg/40mL Alkylating Activity [MoA],Alkylating Drug [EPC] 16729-114_1128e14b-8081-4520-bb22-e0525b1ba3c4 16729-114 HUMAN PRESCRIPTION DRUG Etoposide Etoposide INJECTION INTRAVENOUS 20130915 ANDA ANDA074513 Accord Healthcare Inc. ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 16729-115_0a4ea340-dcd4-2b02-e054-00144ff88e88 16729-115 HUMAN PRESCRIPTION DRUG Mitomycin Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090618 ANDA ANDA064144 Accord Healthcare Inc MITOMYCIN 5 mg/10mL Alkylating Activity [MoA],Alkylating Drug [EPC] 16729-116_0a4ea340-dcd4-2b02-e054-00144ff88e88 16729-116 HUMAN PRESCRIPTION DRUG Mitomycin Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110311 ANDA ANDA064144 Accord Healthcare Inc MITOMYCIN 40 mg/80mL Alkylating Activity [MoA],Alkylating Drug [EPC] 16729-117_642ad9b5-fc42-4f81-a05b-2b6607a95590 16729-117 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA091594 Accord Healthcare Inc. GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 16729-118_642ad9b5-fc42-4f81-a05b-2b6607a95590 16729-118 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA091594 Accord Healthcare Inc. GEMCITABINE HYDROCHLORIDE 2 g/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 16729-119_fb13016e-b627-486e-9efe-c17a59ade707 16729-119 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20130115 ANDA ANDA202717 Accord Healthcare Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 16729-120_9e1f9790-a935-495b-8ba0-14214bb4393c 16729-120 HUMAN PRESCRIPTION DRUG DOCETAXEL docetaxel KIT 20110630 NDA NDA201195 Accord Healthcare Inc. 16729-123_2e82418b-3175-4843-ab6b-86e6be3619ed 16729-123 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20111231 ANDA ANDA201335 Accord Healthcare, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 16729-124_2e82418b-3175-4843-ab6b-86e6be3619ed 16729-124 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20111231 ANDA ANDA201335 Accord Healthcare, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 16729-134_0e55897d-01cc-4c0b-8f90-d7781d00271d 16729-134 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20130902 ANDA ANDA203154 Accord Healthcare Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 16729-135_0e55897d-01cc-4c0b-8f90-d7781d00271d 16729-135 HUMAN PRESCRIPTION DRUG Allopurinol ALLOPURINOL TABLET ORAL 20130902 ANDA ANDA203154 Accord Healthcare Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 16729-136_ebc11109-e7bf-452d-b675-4b3236d54164 16729-136 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20101124 ANDA ANDA077147 Accord Healthcare Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16729-137_ebc11109-e7bf-452d-b675-4b3236d54164 16729-137 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20101124 ANDA ANDA077147 Accord Healthcare Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16729-138_ebc11109-e7bf-452d-b675-4b3236d54164 16729-138 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20101124 ANDA ANDA077147 Accord Healthcare Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 16729-139_5c536e87-9545-4582-ba15-5bf63c832d2a 16729-139 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110301 ANDA ANDA074550 Accord Healthcare Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 16729-140_5c536e87-9545-4582-ba15-5bf63c832d2a 16729-140 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110301 ANDA ANDA074550 Accord Healthcare Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 16729-145_72c7da07-d7db-4e91-bf4f-2039572e28f1 16729-145 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Accord Healthcare Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 16729-146_72c7da07-d7db-4e91-bf4f-2039572e28f1 16729-146 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Accord Healthcare Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 16729-147_72c7da07-d7db-4e91-bf4f-2039572e28f1 16729-147 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Accord Healthcare Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 16729-148_72c7da07-d7db-4e91-bf4f-2039572e28f1 16729-148 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Accord Healthcare Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 16729-149_72c7da07-d7db-4e91-bf4f-2039572e28f1 16729-149 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Accord Healthcare Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 16729-150_72c7da07-d7db-4e91-bf4f-2039572e28f1 16729-150 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Accord Healthcare Inc. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 16729-151_06a82171-e25c-0427-e054-00144ff88e88 16729-151 HUMAN PRESCRIPTION DRUG topotecan hydrochloride topotecan hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130701 ANDA ANDA202351 Accord Healthcare Inc. TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 16729-152_6191555d-eaa8-43a7-878e-7b8b87681637 16729-152 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140701 ANDA ANDA202392 Accord Healthcare Inc. RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16729-153_6191555d-eaa8-43a7-878e-7b8b87681637 16729-153 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140701 ANDA ANDA202392 Accord Healthcare Inc. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16729-154_6191555d-eaa8-43a7-878e-7b8b87681637 16729-154 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140701 ANDA ANDA202392 Accord Healthcare Inc. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16729-155_6191555d-eaa8-43a7-878e-7b8b87681637 16729-155 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140701 ANDA ANDA202392 Accord Healthcare Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16729-156_0579a12e-6919-3fa0-e054-00144ff88e88 16729-156 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20130902 ANDA ANDA078155 Accord Healthcare, Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 16729-167_dfb4f81b-38bc-4b3f-8240-ac8eaa185a16 16729-167 HUMAN PRESCRIPTION DRUG Tramadol Tramadol Hydrochloride Tablets TABLET ORAL 20131001 ANDA ANDA202390 Accord Healthcare, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 16729-168_b0fd9850-a24b-4a24-aedb-3c1fc159af71 16729-168 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130115 ANDA ANDA202389 Accord Healthcare Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16729-169_b0fd9850-a24b-4a24-aedb-3c1fc159af71 16729-169 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130115 ANDA ANDA202389 Accord Healthcare Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16729-170_b0fd9850-a24b-4a24-aedb-3c1fc159af71 16729-170 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130115 ANDA ANDA202389 Accord Healthcare Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 16729-171_0a726dec-a553-5b5d-e054-00144ff8d46c 16729-171 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Accord Healthcare Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 16729-172_0a726dec-a553-5b5d-e054-00144ff8d46c 16729-172 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Accord Healthcare Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 16729-173_0a726dec-a553-5b5d-e054-00144ff8d46c 16729-173 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Accord Healthcare Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 16729-174_0a726dec-a553-5b5d-e054-00144ff8d46c 16729-174 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Accord Healthcare Inc. AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 16729-175_0a726dec-a553-5b5d-e054-00144ff8d46c 16729-175 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Accord Healthcare Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 16729-176_0a726dec-a553-5b5d-e054-00144ff8d46c 16729-176 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Accord Healthcare Inc. AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 16729-179_84472fc8-ea7c-4c00-90e2-3697608caa23 16729-179 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE Amlodipine besylate TABLET ORAL 20130701 ANDA ANDA202553 Accord Healthcare Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 16729-180_84472fc8-ea7c-4c00-90e2-3697608caa23 16729-180 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE Amlodipine besylate TABLET ORAL 20130701 ANDA ANDA202553 Accord Healthcare Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 16729-181_84472fc8-ea7c-4c00-90e2-3697608caa23 16729-181 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE Amlodipine besylate TABLET ORAL 20130701 ANDA ANDA202553 Accord Healthcare Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 16729-182_babb1b20-fe82-40ba-8e7a-0c56fe433b4a 16729-182 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130115 ANDA ANDA202556 Accord Healthcare Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 16729-183_babb1b20-fe82-40ba-8e7a-0c56fe433b4a 16729-183 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130115 ANDA ANDA202556 Accord Healthcare Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 16729-184_babb1b20-fe82-40ba-8e7a-0c56fe433b4a 16729-184 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130115 ANDA ANDA202556 Accord Healthcare Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 16729-194_0698075e-d870-402e-e054-00144ff88e88 16729-194 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20130915 ANDA ANDA202554 Accord Healthcare Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16729-195_0698075e-d870-402e-e054-00144ff88e88 16729-195 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20130915 ANDA ANDA202554 Accord Healthcare Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16729-196_0698075e-d870-402e-e054-00144ff88e88 16729-196 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20130915 ANDA ANDA202554 Accord Healthcare Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16729-197_0698075e-d870-402e-e054-00144ff88e88 16729-197 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20130915 ANDA ANDA202554 Accord Healthcare Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16729-198_0698075e-d870-402e-e054-00144ff88e88 16729-198 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20130915 ANDA ANDA202554 Accord Healthcare Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16729-199_0698075e-d870-402e-e054-00144ff88e88 16729-199 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20130915 ANDA ANDA202554 Accord Healthcare Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 16729-211_e65f9e6f-4524-487d-8f35-9bfc4e40b7c9 16729-211 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20141001 ANDA ANDA202824 Accord Healthcare Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 16729-212_e65f9e6f-4524-487d-8f35-9bfc4e40b7c9 16729-212 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20141001 ANDA ANDA202824 Accord Healthcare Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 16729-213_e65f9e6f-4524-487d-8f35-9bfc4e40b7c9 16729-213 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20141001 ANDA ANDA202824 Accord Healthcare Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 16729-214_e65f9e6f-4524-487d-8f35-9bfc4e40b7c9 16729-214 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20141001 ANDA ANDA202824 Accord Healthcare Inc. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 16729-218_3c0bf365-172f-4acb-b7f2-9ee1538545fc 16729-218 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel bisulphate TABLET, FILM COATED ORAL 20130515 ANDA ANDA202925 Accord Healthcare Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 16729-219_3c0bf365-172f-4acb-b7f2-9ee1538545fc 16729-219 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel bisulphate TABLET, FILM COATED ORAL 20130515 ANDA ANDA202925 Accord Healthcare Inc. CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 16729-228_9e1f9790-a935-495b-8ba0-14214bb4393c 16729-228 HUMAN PRESCRIPTION DRUG DOCETAXEL docetaxel KIT 20110630 NDA NDA201195 Accord Healthcare Inc. 16729-231_9e1f9790-a935-495b-8ba0-14214bb4393c 16729-231 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION INTRAVENOUS 20120701 NDA NDA201195 Accord Healthcare Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 16729-246_f3041806-e608-47e0-89ae-3f4125c9ccfe 16729-246 HUMAN PRESCRIPTION DRUG Mitomycin Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130503 ANDA ANDA064144 Accord Healthcare Inc MITOMYCIN 5 mg/10mL Alkylating Activity [MoA],Alkylating Drug [EPC] 16729-247_e40c2556-f14f-4dc1-a152-89d584dc9ff9 16729-247 HUMAN PRESCRIPTION DRUG Mitomycin Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130503 ANDA ANDA064144 Accord Healthcare Inc MITOMYCIN 20 mg/10mL Alkylating Activity [MoA],Alkylating Drug [EPC] 16729-248_e40c2556-f14f-4dc1-a152-89d584dc9ff9 16729-248 HUMAN PRESCRIPTION DRUG Mitomycin Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130503 ANDA ANDA064144 Accord Healthcare Inc MITOMYCIN 40 mg/10mL Alkylating Activity [MoA],Alkylating Drug [EPC] 16729-262_cce459a9-a767-47ef-b1b8-84066c7cef49 16729-262 HUMAN PRESCRIPTION DRUG Etoposide Etoposide INJECTION INTRAVENOUS 20130801 ANDA ANDA074513 Accord Healthcare Inc. ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 16729-267_9e1f9790-a935-495b-8ba0-14214bb4393c 16729-267 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION INTRAVENOUS 20130515 NDA NDA201195 Accord Healthcare Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 16729-276_33cef88a-1dc9-45a7-b178-d0195a8a80c3 16729-276 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20140201 ANDA ANDA040743 Accord Healthcare, Inc. FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 16729-276_e940e06c-c12f-45ad-a50e-cbb0123175c0 16729-276 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20140201 ANDA ANDA040798 Accord Healthcare, Inc. FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 16729-277_ffb66c4a-52b1-4088-9a69-2a2cf2437a1c 16729-277 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20140201 ANDA ANDA040716 Accord Healthcare, Inc. METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 16781-154_5a833646-bee4-44d0-94f8-a580d78062c6 16781-154 HUMAN PRESCRIPTION DRUG Clarifoam EF SULFUR,SULFACETAMIDE SODIUM AEROSOL, FOAM TOPICAL 20070601 20150731 UNAPPROVED DRUG OTHER Onset Dermatologics LLC SULFACETAMIDE SODIUM; SULFUR 10; 5 g/100g; g/100g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 16781-189_324a9448-648f-4085-bf17-26ffac166ced 16781-189 HUMAN PRESCRIPTION DRUG Hylatopic Emollient AEROSOL, FOAM TOPICAL 20090601 PREMARKET NOTIFICATION K083024 Onset Dermatologics LLC 16781-375_8c1d234a-e5ed-4ec7-81f0-e74713518f07 16781-375 HUMAN PRESCRIPTION DRUG TRETIN.X TRETINOIN CREAM TOPICAL 20130402 ANDA ANDA075264 Onset Dermatologics LLC TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 16781-376_8c1d234a-e5ed-4ec7-81f0-e74713518f07 16781-376 HUMAN PRESCRIPTION DRUG TRETIN.X TRETINOIN CREAM TOPICAL 20130402 ANDA ANDA090098 Onset Dermatologics LLC TRETINOIN .375 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 16781-378_8c1d234a-e5ed-4ec7-81f0-e74713518f07 16781-378 HUMAN PRESCRIPTION DRUG TRETIN.X TRETINOIN CREAM TOPICAL 20130402 ANDA ANDA075265 Onset Dermatologics LLC TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 16781-379_8c1d234a-e5ed-4ec7-81f0-e74713518f07 16781-379 HUMAN PRESCRIPTION DRUG TRETIN.X TRETINOIN CREAM TOPICAL 20130402 ANDA ANDA075213 Onset Dermatologics LLC TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 16781-382_6ec92ef0-61f0-4aa6-b5d8-8afa39e47b84 16781-382 HUMAN PRESCRIPTION DRUG Locoid HYDROCORTISONE BUTYRATE CREAM TOPICAL 20130703 NDA NDA018514 Onset Dermatologics, LLC HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16781-384_b57e27d2-8476-4b8d-b2db-bfffd94f1e56 16781-384 HUMAN PRESCRIPTION DRUG Locoid Lipocream HYDROCORTISONE BUTYRATE CREAM TOPICAL 20130703 NDA NDA020769 Onset Dermatologics LLC HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16781-389_9538de88-fd0d-4b6d-882b-072c2f7176cf 16781-389 HUMAN PRESCRIPTION DRUG Locoid HYDROCORTISONE BUTYRATE OINTMENT TOPICAL 20130708 NDA NDA018652 Onset Dermatologics, LLC HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16781-391_d5a2110e-af28-40e3-b91f-f543c49f296e 16781-391 HUMAN PRESCRIPTION DRUG Locoid HYDROCORTISONE BUTYRATE SOLUTION TOPICAL 20130702 NDA NDA019116 Onset Dermatologics, LLC HYDROCORTISONE BUTYRATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16781-392_91904daa-9d0e-437e-b591-f5c7a2850acb 16781-392 HUMAN PRESCRIPTION DRUG Locoid HYDROCORTISONE BUTYRATE LOTION TOPICAL 20130703 NDA NDA022076 Onset Dermatologics, LLC HYDROCORTISONE BUTYRATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 16781-400_1036bd0c-3b85-47e4-9a91-0c8fc860030f 16781-400 HUMAN PRESCRIPTION DRUG Minocin MINOCYCLINE HYDROCHLORIDE CAPSULE ORAL 20130507 20150831 NDA NDA050649 Onset Dermatologics, LLC MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 16781-400_39aee369-b5dc-4ff4-98de-06fb4189c733 16781-400 HUMAN PRESCRIPTION DRUG Minocin minocycline hydrochloride CAPSULE, COATED PELLETS ORAL 19900531 NDA NDA050649 Onset Dermatologics LLC MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 16781-401_aca07889-03b5-4448-ac7d-4bce99f7d0e1 16781-401 HUMAN PRESCRIPTION DRUG Minocin MINOCYCLINE HYDROCHLORIDE KIT 20130617 20160131 NDA NDA050649 Onset Dermatologics, LLC 16781-403_1036bd0c-3b85-47e4-9a91-0c8fc860030f 16781-403 HUMAN PRESCRIPTION DRUG Minocin MINOCYCLINE HYDROCHLORIDE CAPSULE ORAL 20130507 20150831 NDA NDA050649 Onset Dermatologics, LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 16781-403_39aee369-b5dc-4ff4-98de-06fb4189c733 16781-403 HUMAN PRESCRIPTION DRUG Minocin minocycline hydrochloride CAPSULE, COATED PELLETS ORAL 19900531 NDA NDA050649 Onset Dermatologics LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 16781-404_aca07889-03b5-4448-ac7d-4bce99f7d0e1 16781-404 HUMAN PRESCRIPTION DRUG Minocin MINOCYCLINE HYDROCHLORIDE KIT 20130617 20160131 NDA NDA050649 Onset Dermatologics, LLC 16781-426_a9f460b9-bf3f-4a8a-9e99-bd344ea4463b 16781-426 HUMAN PRESCRIPTION DRUG TretinX TRETINOIN KIT TOPICAL 20130603 20160301 ANDA ANDA075264 Onset Dermatologics, LLC 16781-427_a9f460b9-bf3f-4a8a-9e99-bd344ea4463b 16781-427 HUMAN PRESCRIPTION DRUG TretinX TRETINOIN KIT TOPICAL 20130603 20160301 ANDA ANDA075265 Onset Dermatologics, LLC 16781-428_a9f460b9-bf3f-4a8a-9e99-bd344ea4463b 16781-428 HUMAN PRESCRIPTION DRUG TretinX TRETINOIN KIT 20130603 ANDA ANDA075213 Onset Dermatologics, LLC 16781-446_8c1d234a-e5ed-4ec7-81f0-e74713518f07 16781-446 HUMAN PRESCRIPTION DRUG TRETIN.X TRETINOIN CREAM TOPICAL 20130402 ANDA ANDA202209 Onset Dermatologics LLC TRETINOIN .75 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 16781-457_39aee369-b5dc-4ff4-98de-06fb4189c733 16781-457 HUMAN PRESCRIPTION DRUG Minocin minocycline hydrochloride CAPSULE, COATED PELLETS ORAL 19900531 NDA NDA050649 Onset Dermatologics LLC MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 16781-462_49bf81de-9e25-4a1a-8833-9d93824f64c3 16781-462 HUMAN PRESCRIPTION DRUG Clindagel CLINDAMYCIN GEL TOPICAL 20131125 NDA NDA050782 Onset Dermatologics LLC CLINDAMYCIN PHOSPHATE 1 g/10mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 16837-298_1bf1af18-e522-4bdb-bce2-8381d36fa7a6 16837-298 HUMAN OTC DRUG Pepcid Complete Famotidine, Calcium carbonate, and Magnesium hydroxide TABLET, CHEWABLE ORAL 20090301 NDA NDA020958 McNeil Consumer Pharmaceuticals Co. CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 16837-455_a6e0fbe3-cf1e-44f5-904c-b48b6a5fbd14 16837-455 HUMAN OTC DRUG Mylanta Gas Maximum Strength Dimethicone TABLET, CHEWABLE ORAL 19900101 OTC MONOGRAPH FINAL part332 McNeil Consumer Pharmaceuticals Co. DIMETHICONE 125 mg/1 16837-854_3a2c7054-e8a4-4bc9-99f7-9f28d0814156 16837-854 HUMAN OTC DRUG Pepcid AC Famotidine TABLET, CHEWABLE ORAL 20080201 NDA NDA020801 McNeil Consumer Pharmaceuticals Co. FAMOTIDINE 20 mg/1 16837-855_9c3482fe-2b1b-40ee-93a9-24107a01df0c 16837-855 HUMAN OTC DRUG PEPCID AC Maximum Strength Famotidine TABLET, FILM COATED ORAL 20030901 NDA NDA020325 McNeil Consumer Pharmaceuticals Co. FAMOTIDINE 20 mg/1 16837-861_9a056551-8b8e-4a56-a702-bd5cf8ceb636 16837-861 HUMAN OTC DRUG Mylanta Gas Maximum Strength Dimethicone TABLET, CHEWABLE ORAL 19960601 OTC MONOGRAPH FINAL part332 McNeil Consumer Pharmaceuticals Co. DIMETHICONE 125 mg/1 16837-872_2287bf93-0f38-4dfe-b858-ea3b9a3b12fd 16837-872 HUMAN OTC DRUG Pepcid AC Original Strength Famotidine TABLET, FILM COATED ORAL 19951001 NDA NDA020325 McNeil Consumer Pharmaceuticals Co. FAMOTIDINE 10 mg/1 16837-891_7e009a59-fb1c-4d6e-9a3e-cd4f88478e5e 16837-891 HUMAN OTC DRUG Pepcid Complete famotidine, calcium carbonate, and magnesium hydroxide TABLET, CHEWABLE ORAL 20090301 NDA NDA020958 McNeil Consumer Pharmaceuticals Co. CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 16853-1261_110b051e-8123-4443-b9c3-9e3181a528b2 16853-1261 HUMAN OTC DRUG ALLEROFF Cetirizine Hydrochloride SYRUP ORAL 20100115 NDA NDA022155 Corporacion Infarmasa CETIRIZINE HYDROCHLORIDE 1 mg/1 16853-1305_98661a3c-c95c-4ab1-b62f-87dde7f88296 16853-1305 HUMAN OTC DRUG ALLEROFF Cetirizine Hydrochloride TABLET ORAL 20100101 NDA NDA019835 Corporacion Infarmasa CETIRIZINE HYDROCHLORIDE 10 mg/1 16853-1307_bdd5bed7-9c23-4457-87ab-cfefadfc97bb 16853-1307 HUMAN OTC DRUG ALLEROFF Cetirizine Hydrochloride TABLET ORAL 20100101 NDA NDA019835 Corporacion Infarmasa CETIRIZINE HYDROCHLORIDE 10 mg/1 16853-1308_b16d55b9-70a2-4734-a8f4-bfd1cd108be4 16853-1308 HUMAN OTC DRUG OMESEC Omeprazole CAPSULE, DELAYED RELEASE ORAL 20100228 ANDA ANDA075410 Corporacion Infarmasa OMEPRAZOLE 20 mg/1 16864-001_962eba7d-ad92-ced2-0357-7c2274b452a0 16864-001 HUMAN OTC DRUG JointFlex Camphor CREAM TOPICAL 20100416 OTC MONOGRAPH FINAL part341 MOBERG PHARMA NORTH AMERICA LLC CAMPHOR (SYNTHETIC) 3.58 g/114g 16864-002_1b8900f0-2e69-2620-01fb-3a87740aa3af 16864-002 HUMAN OTC DRUG JointFlex ICE Natural Menthol LOTION TOPICAL 20100406 OTC MONOGRAPH FINAL part341 MOBERG PHARMA NORTH AMERICA LLC MENTHOL 8.5 g/100mL 16864-011_640d0d25-5368-b0c5-b67b-9efb59e2b01b 16864-011 HUMAN OTC DRUG Kerasal Natural Menthol LOTION TOPICAL 20100416 OTC MONOGRAPH FINAL part341 MOBERG PHARMA NORTH AMERICA LLC MENTHOL 8.5 mg/88mL 16864-012_8e9fa043-aead-9f61-f46b-0ebfc70bbdb4 16864-012 HUMAN OTC DRUG Kerasal PF-10 Natural Menthol LOTION TOPICAL 20100624 OTC MONOGRAPH FINAL part341 MOBERG PHARMA NORTH AMERICA LLC MENTHOL 8.5 mg/88mL 16864-013_8ad02b60-efc9-faf3-0b59-652ed3ae85d5 16864-013 HUMAN OTC DRUG Kerasal NeuroCream Capsaicin, Camphor CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 MOBERG PHARMA NORTH AMERICA LLC CAMPHOR (SYNTHETIC); CAPSAICIN 5.65; .075 g/100g; g/100g 16864-201_7658c4d2-d159-c823-2c7d-42a286e1fd15 16864-201 HUMAN OTC DRUG Vanquish Acetaminophen, Aspirin, and Caffeine TABLET, COATED ORAL 20120626 ANDA ANDA075794 MOBERG PHARMA NORTH AMERICA LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 194; 227; 33 mg/1; mg/1; mg/1 16864-240_31c07962-7794-ae22-1ac6-3ad4c4880c82 16864-240 HUMAN OTC DRUG Domeboro Aluminum Sulfate Tetradecahydrate, Calcium Acetate Monohydrate POWDER, FOR SOLUTION TOPICAL 20120626 OTC MONOGRAPH NOT FINAL part347 MOBERG PHARMA NORTH AMERICA LLC ALUMINUM SULFATE TETRADECAHYDRATE; CALCIUM ACETATE MONOHYDRATE 1347; 952 mg/1; mg/1 16903-168_f2055a4b-a1a8-4674-b7ea-05ea67cff601 16903-168 HUMAN OTC DRUG TheraDerm Pain Relieving Patch Methyl Salicylate Menthol Eucalyptus PATCH TOPICAL 20140605 23880606 OTC MONOGRAPH NOT FINAL part348 Manna Omni International EUCALYPTUS OIL; MENTHOL; METHYL SALICYLATE 105; 105; 31.5 1/1; 1/1; 1/1 16913-0001_125da24d-ad4f-444f-9590-fd221534d345 16913-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060101 UNAPPROVED MEDICAL GAS Advanced Medical Equipment, LLC OXYGEN 99 L/100L 16995-001_e4ff216e-e4a8-4c7e-b752-ce1621eba1b5 16995-001 HUMAN OTC DRUG FLORIL REDNESS RELIEF NAPHAZOLINE HYDROCHLORIDE SOLUTION/ DROPS OPHTHALMIC 20051110 OTC MONOGRAPH FINAL part349 VITALINE S.A.C. NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 20 3; 2 mg/10mL; mg/mL 16995-002_6becdef5-06d3-4a24-b46b-c8bb682a1339 16995-002 HUMAN OTC DRUG FLORIL TEARS POLYVINYL ALCOHOL SOLUTION/ DROPS OPHTHALMIC 20051110 OTC MONOGRAPH FINAL part349 VITALINE S.A.C. POLYETHYLENE GLYCOL 400; POLYVINYL ALCOHOL 2; 14 mg/mL; mL/mL 16995-004_94f2f212-eba2-47a6-96ac-9f9639e2a09d 16995-004 HUMAN OTC DRUG FLORIL TEARS POLYVINYL ALCOHOL SOLUTION/ DROPS OPHTHALMIC 20051110 OTC MONOGRAPH FINAL part349 VITALINE S.A.C. POLYVINYL ALCOHOL 14 mg/mL 17089-025_57313e64-76c2-479b-8fec-ebb81c434a41 17089-025 HUMAN OTC DRUG GUNA-FLU ACONITUM NAPELLUS - ASCLEPIAS CURASSAVICA - ATROPA BELLADONNA - CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE - COPPER - ECHINACEA ANGUSTIFOLIA - HAEMOPHILUS INFLUENZAE TYPE B - PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ACONITUM NAPELLUS; ASCLEPIAS CURASSAVICA; ATROPA BELLADONNA; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; COPPER; ECHINACEA ANGUSTIFOLIA; HAEMOPHILUS INFLUENZAE TYPE B 5; 5; 5; 7; 3; 3; 9 [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g 17089-046_b48e9662-3a99-4e2f-b83e-c6f46efcda9d 17089-046 HUMAN OTC DRUG ANTI AGE SKIN ALPHA-TOCOPHEROL - ASCOPHYLLUM NODOSUM - BOTRYOGLOSSUM PLATYCARPUM - FUCUS SERRATUS - FUCUS VESICULOSUS - ISOLEUCINE - LEUCINE - RETINOL - SELENIUM - SUS SCROFA CAPILLARY TISSUE - SUS SCROFA COLLAGEN PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ALPHA-TOCOPHEROL; ASCOPHYLLUM NODOSUM; BOTRYOGLOSSUM PLATYCARPUM; FUCUS SERRATUS; FUCUS VESICULOSUS; ISOLEUCINE; LAMINARIA DIGITATA; LEUCINE; RETINOL; SELENIUM; SUS SCROFA CAPILLARY TISSUE; SUS SCROFA COLLAGEN; SUS SCROFA PLACENTA; SUS SCROFA SKIN; UBIDECARENONE; ULVA LACTUCA EXTRACT 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 17089-061_72abcc1d-7658-4bd1-a138-6c12cbe4b09f 17089-061 HUMAN OTC DRUG ANTI AGE FACE ASIAN GINSENG - CANAKINUMAB - ELEUTHERO - GERMANIUM DIOXIDE - ISOLEUCINE - LEUCINE - PROLINE - SUS SCROFA COLLAGEN - SUS SCROFA SKIN - VALINE - WITCH HAZEL - PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ASIAN GINSENG; CANAKINUMAB; ELEUTHERO; GERMANIUM DIOXIDE; HAMAMELIS VIRGINIANA LEAF; ISOLEUCINE; LEUCINE; PROLINE; SUS SCROFA COLLAGEN; SUS SCROFA SKIN; VALINE 3; 5; 3; 4; 3; 4; 4; 4; 4; 4; 9 [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 17089-067_a34bfc97-6822-47bf-8e2c-1764fc86103d 17089-067 HUMAN OTC DRUG ANTI AGE STRESS ACETYLCYSTEINE - BALLOTA FOETIDA - EPINEPHRINE - GLUTATHIONE - INTERFERON GAMMA-1B - LENOGRASTIM - LITHIUM CARBONATE - MELATONIN - PENICILLIUM GLABRUM - POTASSIUM CARBONATE - PUMMELO - RHODOTORULA RUB PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ACETYLCYSTEINE; BALLOTA FOETIDA; EPINEPHRINE; EPINEPHRINE; GLUTATHIONE; INTERFERON GAMMA-1B; LENOGRASTIM; LITHIUM CARBONATE; MELATONIN; MELATONIN; PENICILLIUM GLABRUM; POTASSIUM CARBONATE; PUMMELO; RHODOTORULA RUBRA; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; STRYCHNOS NUX-VOMICA SEED; STRYCHNOS NUX-VOMICA SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA CEREBRAL CORTEX; SUS SCROFA CEREBRAL CORTEX; SUS SCROFA STOMACH; SUS SCROFA SUPERIOR GASTRIC PLEXUS; SUS SCROFA THALAMUS 4; 3; 15; 9; 4; 5; 4; 8; 15; 4; 8; 9; 3; 8; 9; 15; 5; 7; 9; 4; 7; 7; 7; 7 [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 17089-068_2e674588-6493-4b3e-8f51-95c720e44510 17089-068 HUMAN OTC DRUG ANTI AGE VEIN ACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA - ARSENIC TRIOXIDE - ATROPA BELLADONNA - CALCIUM FLUORIDE - CENTELLA ASIATICA - CINCHONA OFFICINALIS BARK - CRANBERRY - HORSE CHESTNUT - IRON - LACH PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CALCIUM FLUORIDE; CENTELLA ASIATICA; CINCHONA OFFICINALIS BARK; CRANBERRY; HORSE CHESTNUT; IRON; LACHESIS MUTA VENOM; MERCURY; PINEAPPLE; PULSATILLA VULGARIS; SUS SCROFA ARTERY; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA VEIN; VISCUM ALBUM FRUIT; WITCH HAZEL 10; 10; 10; 12; 10; 8; 3; 10; 3; 3; 10; 10; 10; 3; 10; 4; 7; 4; 3; 3 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g 17089-075_c15ed9e7-0fb7-4ea6-829b-3439c05a4760 17089-075 HUMAN OTC DRUG OMEOSPORT .ALPHA.-KETOGLUTARIC ACID - ACONITIC ACID, CIS - ADENOSINE TRIPHOSPHATE - ALPHA LIPOIC ACID - ASCORBIC ACID - ASIAN GINSENG - BARIUM CATION - BEET - CEROUS OXALATE NONAHYDRATE - COENZYME A - CYSTEINE PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa .ALPHA.-KETOGLUTARIC ACID; ACONITIC ACID, CIS-; ADENOSINE TRIPHOSPHATE; ALPHA LIPOIC ACID; ASCORBIC ACID; ASIAN GINSENG; BARIUM OXALOSUCCINATE; BEET; CEROUS OXALATE NONAHYDRATE; COENZYME A; CYSTEINE; FUMARIC ACID; LACTIC ACID; MAGNESIUM CARBONATE; MALIC ACID; MANGANESE PHOSPHATE, DIBASIC; PORK; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA EMBRYO; THIAMINE HYDROCHLORIDE 6; 6; 8; 6; 4; 3; 6; 2; 6; 6; 6; 6; 8; 2; 6; 6; 6; 6; 6; 6; 6; 6; 10; 6; 4 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 17089-076_5101e745-1f5e-473f-b2d2-dd625e9cea96 17089-076 HUMAN OTC DRUG CITOMIX ALDESLEUKIN - BINETRAKIN - CANAKINUMAB - CENTELLA ASIATICA - CRANBERRY - HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED) - INTERFERON GAMMA-1B - LENOGRASTIM - PINEAPPLE - SUS SCROFA BONE MARROW - SUS SCROFA SMA PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ALDESLEUKIN; BINETRAKIN; CANAKINUMAB; CENTELLA ASIATICA; CRANBERRY; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); INTERFERON GAMMA-1B; LENOGRASTIM; PINEAPPLE; SUS SCROFA BONE MARROW; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA THYMUS 5; 4; 5; 3; 3; 7; 4; 4; 3; 4; 4; 4 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 17089-231_8ca7517a-9bd7-4e93-945c-4d391a9ef022 17089-231 HUMAN OTC DRUG GUNA-FEM ADENOSINUM CICLOPHOSPHORICUM - LILIUM TIGRINUM - MELATONIN - SUS SCROFA ADRENAL GLAND - SUS SCROFA CORPUS LUTEUM - SUS SCROFA HYPOTHALAMUS - SUS SCROFA OVARY - SUS SCROFA PANCREAS - SUS SCROFA PINEAL SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ADENOSINE CYCLIC 3',5'-PHOSPHATE; LILIUM TIGRINUM; MELATONIN; SUS SCROFA ADRENAL GLAND; SUS SCROFA CORPUS LUTEUM; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PANCREAS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID 6; 6; 200; 30; 30; 30; 6; 30; 30; 30; 30; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-233_fcfa9fde-5872-4e52-ac1e-949aadb2688a 17089-233 HUMAN OTC DRUG GUNA-MALE ADENOSINUM CICLOPHOSPHORICUM - MELATONIN - PHOSPHORUS - SUS SCROFA ADRENAL GLAND - SUS SCROFA HYPOTHALAMUS - SUS SCROFA PANCREAS - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - SUS SCROFA TES SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ADENOSINE CYCLIC 3',5'-PHOSPHATE; MELATONIN; PHOSPHORUS; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PANCREAS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA TESTICLE; SUS SCROFA THYMUS; THYROID; TURNERA DIFFUSA TOP 6; 30; 6; 30; 30; 30; 30; 30; 30; 30; 30; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-235_e307bc6e-8268-4e12-8832-0453194b3b98 17089-235 HUMAN OTC DRUG GUNA-TONSILS ANGELICA SINENSIS ROOT - BINETRAKIN - INTERLEUKIN-3 - LENOGRASTIM - MELATONIN - REISHI - SHIITAKE MUSHROOM - SUS SCROFA BLOOD - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA SPLEEN - I PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ANGELICA SINENSIS ROOT; BINETRAKIN; INTERLEUKIN-11; INTERLEUKIN-3; LENOGRASTIM; MELATONIN; REISHI; SHIITAKE MUSHROOM; SUS SCROFA BLOOD; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SPLEEN 3; 4; 5; 5; 4; 4; 8; 8; 7; 4; 4 [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 17089-237_1303b1fe-a794-47f7-a0d1-051071458112 17089-237 HUMAN OTC DRUG GUNA-REACT ANGELICA SINENSIS ROOT - ARNICA MONTANA - ASIAN GINSENG - ECHINACEA ANGUSTIFOLIA - FOMITOPSIS PINICOLA FRUITING BODY - INTERFERON GAMMA-1B - PAEONIA OFFICINALIS ROOT - PORK LIVER - REISHI - SILYBUM MA PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ANGELICA SINENSIS ROOT; ARNICA MONTANA; ASIAN GINSENG; ECHINACEA ANGUSTIFOLIA; FOMITOPSIS PINICOLA FRUITING BODY; INTERFERON GAMMA-1B; PAEONIA OFFICINALIS ROOT; PORK LIVER; REISHI; SILYBUM MARIANUM SEED; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; TURMERIC 3; 4; 1; 3; 8; 4; 3; 4; 8; 3; 4; 3 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g 17089-242_9a846771-5ae6-4ff7-b87a-d6a930435bfc 17089-242 HUMAN OTC DRUG GUNA-ADDICT 1 CAFFEINE - CHELIDONIUM MAJUS - DIEFFENBACHIA SEGUINE - JUNIPER - MATRICARIA RECUTITA - NICOTINE - PAPAVER RHOEAS FLOWER - PLANTAGO MAJOR - SCROPHULARIA NODOSA - SODIUM CHLORIDE - STRYCHNOS NUX-VOMICA SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa CAFFEINE; CHELIDONIUM MAJUS; DIEFFENBACHIA SEGUINE; JUNIPER; MATRICARIA RECUTITA; NICOTINE; PAPAVER RHOEAS FLOWER; PLANTAGO MAJOR; SCROPHULARIA NODOSA; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SUGARCANE; TOBACCO LEAF 6; 1; 4; 1; 1; 6; 12; 1; 1; 9; 9; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-243_65fff701-7e92-4355-9a70-9ae39f5ae64c 17089-243 HUMAN OTC DRUG GUNA-ADDICT 2 ASIAN GINSENG - AVENA SATIVA FLOWERING TOP - BLACK CURRANT - MATRICARIA RECUTITA - ELEUTHERO - ESCHSCHOLZIA CALIFORNICA - HOPS - HYPERICUM PERFORATUM - PASSIFLORA INCARNATA TOP - POTASSIUM PHOSPHATE, SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ASIAN GINSENG; AVENA SATIVA FLOWERING TOP; BLACK CURRANT; ELEUTHERO; ESCHSCHOLZIA CALIFORNICA; HOPS; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA TOP; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; PULSATILLA VULGARIS; PULSATILLA VULGARIS; STEVIA LEAF; VALERIAN 2; 1; 1; 1; 1; 1; 3; 3; 1; 8; 12; 6; 9; 1; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-251_8458a94a-0f00-46ba-8deb-7af4ec3a4597 17089-251 HUMAN OTC DRUG GUNA-VIRUS ALDESLEUKIN - EVERLASTING EXTRACT - FOMITOPSIS PINICOLA FRUITING BODY - INTERFERON GAMMA-1B - MELATONIN - METENKEFALIN - REISHI - RICE - SEROTONIN - SOYBEAN - SUS SCROFA BLOOD - SUS SCROFA SMALL INTES PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ALDESLEUKIN; EVERLASTING EXTRACT; FOMITOPSIS PINICOLA FRUITING BODY; INTERFERON GAMMA-1B; MELATONIN; METENKEFALIN; REISHI; RICE; SEROTONIN; SOYBEAN; SUS SCROFA BLOOD; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA SPLEEN 5; 3; 8; 3; 15; 4; 8; 3; 6; 3; 4; 7; 4 [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 17089-259_c9122c19-6294-416c-a56d-f706a8ae8bf3 17089-259 HUMAN OTC DRUG OSTEOBIOS CALCITONIN HUMAN - CALCIUM CARBONATE - CALCIUM FLUORIDE - CALCIUM PHOSPHATE - ISOLEUCINE - LEUCINE - LYSINE - METHIONINE - PHENYLALANINE - SUS SCROFA BONE - SUS SCROFA PARATHYROID GLAND - THREONINE - SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa CALCITONIN HUMAN; CALCIUM CARBONATE; CALCIUM FLUORIDE; CALCIUM PHOSPHATE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; SUS SCROFA BONE; SUS SCROFA PARATHYROID GLAND; THREONINE; TRYPTOPHAN; VALINE 6; 30; 30; 30; 3; 3; 3; 3; 3; 30; 30; 3; 3; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-260_32e6dc57-b71f-402f-8ae5-d46ab78e1b50 17089-260 HUMAN PRESCRIPTION DRUG GUNA-DIUR AMILORIDE - APIS MELLIFERA - BERBERIS VULGARIS FRUIT - HIERACIUM PILOSELLA FLOWERING TOP - HYDROCHLOROTHIAZIDE - SOLIDAGO VIRGAUREA FLOWERING TOP - SPIRONOLACTONE - SUS SCROFA PITUITARY GLAND - SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa AMILORIDE; APIS MELLIFERA; BERBERIS VULGARIS FRUIT; HIERACIUM PILOSELLA FLOWERING TOP; HYDROCHLOROTHIAZIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SPIRONOLACTONE; SUS SCROFA PITUITARY GLAND 4; 2; .3; .3; 4; .3; 4; 12 [hp_X]/30mL; [hp_X]/30mL; mL/30mL; mL/30mL; [hp_X]/30mL; mL/30mL; [hp_X]/30mL; [hp_X]/30mL Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 17089-265_be6c2c70-9776-4dbc-85b4-c719eb005c6b 17089-265 HUMAN OTC DRUG GUNA-MOOD 5-HYDROXY TRYPTOPHAN,DL - ALFALFA - AVENA SATIVA FLOWERING TOP - LACHESIS MUTA VENOM - PHOSPHORIC ACID - SALIX ALBA BARK - SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI - SEPIA OFFICINALIS JUICE - SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa 5-HYDROXYTRYPTOPHAN, DL-; ALFALFA; AVENA SATIVA FLOWERING TOP; LACHESIS MUTA VENOM; PHOSPHORIC ACID; SALIX ALBA BARK; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SEPIA OFFICINALIS JUICE; SEROTONIN; STRYCHNOS IGNATII SEED; SUS SCROFA PINEAL GLAND; SUS SCROFA THYMUS; TRYPTOPHAN 3; 6; 6; 30; 200; 10; 30; 30; 30; 30; 200; 200; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-269_ad09b988-a13a-4039-918f-90889940221e 17089-269 HUMAN OTC DRUG GUNA-TF HERPES HUMAN HERPESVIRUS 1 - HUMAN HERPESVIRUS 2 - CAPSULE, GELATIN COATED ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2 7; 7 [hp_X]/4600mg; [hp_X]/4600mg 17089-280_4a23899d-80e0-447b-9d88-22a9f3ffbe49 17089-280 HUMAN OTC DRUG GUNA-TF CANDIDA CANDIDA ALBICANS CAPSULE, GELATIN COATED ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa CANDIDA ALBICANS 7 [hp_X]/4600mg 17089-281_69423426-fa1c-4b19-bbe5-fe63ddb688e4 17089-281 HUMAN OTC DRUG GUNA-TF PAPILLOMA HUMAN PAPILLOMAVIRUS CAPSULE, GELATIN COATED ORAL 20080416 UNAPPROVED HOMEOPATHIC Guna spa HUMAN PAPILLOMAVIRUS 7 [hp_X]/4600mg 17089-290_c1c8fd84-05fd-44ac-bf4d-a7a532bd146a 17089-290 HUMAN OTC DRUG GUNA-PMS ARSENIC TRIOXIDE - ESTRADIOL - GOLDENSEAL - LACHESIS MUTA VENOM - MAGNESIUM PHOSPHATE - MATRICARIA RECUTITA - MELATONIN - PROGESTERONE - STRYCHNOS NUX-VOMICA SEED - SULFUR - SUS SCROFA OVARY - SUS SCR SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ARSENIC TRIOXIDE; ESTRADIOL; GOLDENSEAL; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE; MATRICARIA RECUTITA; MELATONIN; PROGESTERONE; STRYCHNOS NUX-VOMICA SEED; SULFUR; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND 6; 6; 6; 4; 6; 6; 4; 6; 6; 6; 8; 8 [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-291_0e8e6d96-f6d6-4354-8428-5b8e7c136f8c 17089-291 HUMAN OTC DRUG GUNA-LYMPHO APIS MELLIFERA - CALENDULA OFFICINALIS FLOWER - CENTELLA ASIATICA - DODECAHYDROXYCYCLOHEXANE DIHYDRATE - EQUISETUM HYEMALE - FUMARIC ACID - GOLDENSEAL - GRAPHITE - JUGLANS REGIA LEAF - LEVOTHYROXINE - SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa APIS MELLIFERA; CALENDULA OFFICINALIS FLOWER; CENTELLA ASIATICA; DODECAHYDROXYCYCLOHEXANE DIHYDRATE; EQUISETUM HYEMALE; FUMARIC ACID; GOLDENSEAL; GRAPHITE; JUGLANS REGIA LEAF; LEVOTHYROXINE; MAGNESIUM PHOSPHATE; MALIC ACID; MYOSOTIS ARVENSIS; PHYTOLACCA AMERICANA ROOT; SARSAPARILLA; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA CAPILLARY TISSUE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA VEIN; TARAXACUM OFFICINALE 8; 1; 1; 6; 3; 6; 1; 30; 3; 12; 6; 6; 3; 3; 3; 6; 6; 6; 6; 6; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-293_e9896bd2-5e01-4cc1-9c6d-90a33898abf2 17089-293 HUMAN OTC DRUG GUNA-BOWEL ALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - CHOLECALCIFEROL - COLLINSONIA - FRANGULA ALNUS BARK - NIACIN - PANTOTHENIC ACID - POTASSIUM CARBONATE - RHUBARB - SILYBUM MARIANUM SEED SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CHOLECALCIFEROL; COLLINSONIA; FRANGULA ALNUS BARK; NIACIN; PANTOTHENIC ACID; POTASSIUM CARBONATE; RHUBARB; SILYBUM MARIANUM SEED; SKATOLE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA COLON; SUS SCROFA RECTUM; TARAXACUM OFFICINALE; THIAMINE 2; 6; 6; 2; 2; 2; 2; 2; 2; 6; 2; 2; 10; 6; 6; 12; 12; 2; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-294_7593c032-7ad0-4a59-9725-c8d5eafb6831 17089-294 HUMAN OTC DRUG GUNA-SLEEP AVENA SATIVA FLOWERING TOP - CANAKINUMAB - CHAMOMILE - HELLEBORUS NIGER ROOT - MELATONIN - MELISSA OFFICINALIS - PULSATILLA VULGARIS - SEROTONIN - STRYCHNOS IGNATII SEED - SUS SCROFA PINEAL GLAND - VA SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa AVENA SATIVA FLOWERING TOP; CANAKINUMAB; CHAMOMILE; HELLEBORUS NIGER ROOT; MELATONIN; MELISSA OFFICINALIS; PULSATILLA VULGARIS; SEROTONIN; STRYCHNOS IGNATII SEED; SUS SCROFA PINEAL GLAND; SUS SCROFA PINEAL GLAND; SUS SCROFA PINEAL GLAND; VALERIAN 6; 4; 6; 6; 4; 6; 6; 6; 6; 12; 30; 6; 6 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL 17089-295_defde9e4-8e07-4454-a089-1865c0f5e667 17089-295 HUMAN OTC DRUG GUNA-DERMO ALDESLEUKIN - ARSENIC TRIOXIDE - ATROPA BELLADONNA - CANAKINUMAB - ECHINACEA ANGUSTIFOLIA - GRAPHITE - MELATONIN - PLANTAGO MAJOR - SOLANUM DULCAMARA FLOWER - SULFUR - SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ALDESLEUKIN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CANAKINUMAB; ECHINACEA ANGUSTIFOLIA; GRAPHITE; MELATONIN; PLANTAGO MAJOR; SOLANUM DULCAMARA FLOWER; SULFUR 4; 6; 6; 7; 6; 6; 4; 4; 6; 6 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL 17089-296_98275e11-99b5-4311-b697-f522355967cb 17089-296 HUMAN OTC DRUG GUNA-HEMORRHOIDS ACTIVATED CHARCOAL - ARNICA MONTANA - ATROPA BELLADONNA - CANAKINUMAB - HYDROCOTYLE ASIATICA EXTRACT - AESCULUS HIPPOCASTANUM FLOWER - MELISSA OFFICINALIS - PAEONIA OFFICINALIS ROOT - PODOPHYLLUM PELT SOLUTION/ DROPS ORAL 20080416 UNAPPROVED HOMEOPATHIC Guna spa ACTIVATED CHARCOAL; AESCULUS HIPPOCASTANUM FLOWER; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ARNICA MONTANA; ATROPA BELLADONNA; CANAKINUMAB; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCOTYLE ASIATICA EXTRACT; MELISSA OFFICINALIS; PAEONIA OFFICINALIS ROOT; PODOPHYLLUM PELTATUM ROOT; PORK LIVER; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA VEIN 10; 6; 4; 6; 6; 4; 6; 6; 6; 6; 4; 12; 6; 6; 4 [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL 17089-298_2857ee3a-3a7b-468a-b370-06f4596806ea 17089-298 HUMAN OTC DRUG GUNA-KIDNEY CHONDRODENDRON TOMENTOSUM ROOT - CLERODENDRANTHUS SPICATUS LEAF - EQUISETUM HYEMALE - ESCHERICHIA COLI - HIERACIUM PILOSELLA FLOWERING TOP - METHYLENE BLUE - NITRIC ACID - ONONIS CAMPESTRIS - PLANTAGO SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa CHONDRODENDRON TOMENTOSUM ROOT; CLERODENDRANTHUS SPICATUS LEAF; EQUISETUM HYEMALE; ESCHERICHIA COLI; HIERACIUM PILOSELLA FLOWERING TOP; METHYLENE BLUE; NITRIC ACID; ONONIS CAMPESTRIS; PLANTAGO MAJOR; PORK KIDNEY; POTASSIUM NITRATE; PROTEUS VULGARIS; QUINHYDRONE; SARSAPARILLA; SOLIDAGO VIRGAUREA FLOWERING TOP; SUCCINIC ACID; SUS SCROFA URETER; SUS SCROFA URINARY BLADDER 2; 2; 3; 12; 1; 8; 12; 2; 2; 8; 12; 12; 8; 2; 1; 6; 8; 8 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-299_8e14ec39-4a98-4fdf-b8d3-a9476a3e5370 17089-299 HUMAN OTC DRUG GUNA-ALLERGY-PREV AMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERF SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa AMBROSIA ARTEMISIIFOLIA; ANGUILLA ROSTRATA BLOOD SERUM; ARUNDO PLINIANA ROOT; ASCLEPIAS CURASSAVICA; BLACK CURRANT; CITRIC ACID MONOHYDRATE; HISTAMINE DIHYDROCHLORIDE; HUMAN INTERLEUKIN 12; INTERFERON GAMMA-1B; MANGANESE GLUCONATE; PARIETARIA OFFICINALIS; PHLEUM PRATENSE; SODIUM PYRUVATE; SODIUM SULFATE; SUCCINIC ACID; SULFUR; URTICA URENS; VIBURNUM OPULUS ROOT; WYETHIA HELENIOIDES ROOT 18; 200; 18; 6; 1; 6; 30; 4; 4; 4; 18; 18; 6; 200; 6; 30; 18; 3; 18 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; mL/30mL; [hp_X]/30mL 17089-301_08245f08-3952-4524-89ab-440ee4a6ffb5 17089-301 HUMAN OTC DRUG GUNA-DIGEST ANGELICA ARCHANGELICA ROOT - ANISUM - ARTEMISIA ABROTANUM FLOWERING TOP - ASCORBIC ACID - CITRULLUS COLOCYNTHIS FRUIT PULP - GENTIANA LUTEA ROOT - MELATONIN - NIACIN - PANCRELIPASE AMYLASE - PANCRELIP SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ANGELICA ARCHANGELICA ROOT; ANISUM; ARTEMISIA ABROTANUM FLOWERING TOP; ASCORBIC ACID; CITRULLUS COLOCYNTHIS FRUIT PULP; GENTIANA LUTEA ROOT; MELATONIN; NIACIN; PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PORK LIVER; SEROTONIN; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA DIENCEPHALON; SUS SCROFA DUODENUM; SUS SCROFA GALL BLADDER; SUS SCROFA PANCREAS; SUS SCROFA PYLORUS; THIAMINE HYDROCHLORIDE; TRYPSIN; TRYPTOPHAN 1; 1; 1; 2; 3; 1; 4; 2; 2; 2; 8; 6; 3; 6; 8; 8; 8; 8; 4; 2; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-302_6197c0b1-e4c3-4206-8b84-6c103a9f5d7b 17089-302 HUMAN OTC DRUG GUNA-STOMACH ACTIVATED CHARCOAL - ANTIMONY TRISULFIDE - BISMUTH SUBNITRATE - DIOSCOREA VILLOSA ROOT - DOPAMINE - HUMAN EPIDERMAL GROWTH FACTOR - IPECAC - OREGANO - PICEA MARIANA RESIN - ROBINIA PSEUDOACACIA BARK - PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; BISMUTH SUBNITRATE; DIOSCOREA VILLOSA ROOT; DOPAMINE; HUMAN EPIDERMAL GROWTH FACTOR; IPECAC; MOMORDICA BALSAMINA IMMATURE FRUIT; OREGANO; PICEA MARIANA RESIN; ROBINIA PSEUDOACACIA BARK; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; SUS SCROFA STOMACH; SUS SCROFA SYMPATHETIC NERVE 6; 30; 6; 3; 6; 4; 30; 3; 10; 3; 2; 30; 30; 30; 6 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 17089-304_9d59a335-db26-44b1-815f-5d603fac7554 17089-304 HUMAN OTC DRUG GUNA-ARTHRO .ALPHA.-KETOGLUTARIC ACID - ALPHA LIPOIC ACID - ASCORBIC ACID - BARIUM OXALOSUCCINATE - BLACK COHOSH - BRYONIA ALBA ROOT - CALCITONIN HUMAN - CHLORINE - COLCHICUM AUTUMNALE BULB - NADIDE - SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa .ALPHA.-KETOGLUTARIC ACID; ALPHA LIPOIC ACID; ASCORBIC ACID; BARIUM OXALOSUCCINATE; BLACK COHOSH; BRYONIA ALBA ROOT; CALCITONIN HUMAN; CHLORINE; COLCHICUM AUTUMNALE BULB; NADIDE; NERVE GROWTH FACTOR; PRASTERONE; QUINHYDRONE; SODIUM DIETHYL OXALACETATE; SOLANUM DULCAMARA FLOWER; STRONTIUM CARBONATE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA ARTERY; SUS SCROFA CARTILAGE; SUS SCROFA CONJUNCTIVA; SUS SCROFA PARATHYROID GLAND; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; SUS SCROFA VEIN; TOXICODENDRON PUBESCENS LEAF; VELAFERMIN 3; 3; 3; 3; 6; 6; 6; 6; 6; 3; 4; 6; 3; 3; 6; 6; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL 17089-306_de54315b-c73e-4e8b-b35f-79c78a3c3dd0 17089-306 HUMAN OTC DRUG GUNA-DIZZY .ALPHA.-KETOGLUTARIC ACID - AMBERGRIS - ANAMIRTA COCCULUS SEED - CONIUM MACULATUM FLOWERING TOP - EPINEPHRINE - FUMARIC ACID - MALIC ACID - MELATONIN - MINERAL OIL - PTERIDIUM AQUILINUM ROOT - PYRIDOX SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa .ALPHA.-KETOGLUTARIC ACID; AMBERGRIS; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; EPINEPHRINE; FUMARIC ACID; MALIC ACID; MELATONIN; MINERAL OIL; PTERIDIUM AQUILINUM ROOT; PYRIDOXINE HYDROCHLORIDE; QUINHYDRONE; QUININE SALICYLATE; SUS SCROFA ARTERY; SUS SCROFA CEREBELLUM; SUS SCROFA PLACENTA; THIAMINE HYDROCHLORIDE; TOBACCO LEAF 6; 6; 4; 3; 6; 6; 6; 4; 8; 8; 6; 6; 6; 6; 6; 6; 4; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-311_b7c55c65-bd66-4003-8aa2-b8b384b90085 17089-311 HUMAN OTC DRUG GUNA-LIVER CEANOTHUS AMERICANUS LEAF - CHELIDONIUM MAJUS - CHIONANTHUS VIRGINICUS BARK - CHOLINE HYDROXIDE - COBALAMIN - CULVER ROOT - FUMARIC ACID - INOSITOL - LYCOPODIUM CLAVATUM SPORE - NIACIN - PORK LIVER - PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CHOLINE HYDROXIDE; COBALAMIN; CULVER'S ROOT; FUMARIC ACID; INOSITOL; LYCOPODIUM CLAVATUM SPORE; NIACIN; PORK LIVER; POTASSIUM SULFATE; POTASSIUM SULFATE; POTASSIUM SULFATE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SILYBUM MARIANUM SEED; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; SODIUM SULFATE; SODIUM SULFATE; SUS SCROFA GALL BLADDER; SUS SCROFA JEJUNUM; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; TARAXACUM OFFICINALE; THIAMINE HYDROCHLORIDE 6; 2; 6; 4; 4; 6; 4; 4; 6; 6; 6; 12; 6; 8; 6; 6; 2; 4; 4; 12; 6; 8; 8; 8; 8; 8; 2; 6 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 17089-337_3ae5eb9a-7a4f-4c91-92b5-9bf9feb19e6f 17089-337 HUMAN OTC DRUG GUNA-RERIO DANIO RERIO EGG SOLUTION/ DROPS ORAL 20070418 UNAPPROVED HOMEOPATHIC Guna spa DANIO RERIO EGG 4 [hp_X]/30mL 17089-346_97ce693a-9c10-4e4c-b8d2-3b7f60f93234 17089-346 HUMAN OTC DRUG GUNA-PROSTATE ALDESLEUKIN - BARIUM CARBONATE - CHASTE TREE - CHIMAPHILA UMBELLATA - CLEMATIS VITALBA - CONIUM MACULATUM FLOWERING TOP - DELPHINIUM STAPHISAGRIA SEED - DIGITALIS - FERRIC PICRATE - HUMAN INTERLEUKIN- SOLUTION/ DROPS ORAL 20080416 UNAPPROVED HOMEOPATHIC Guna spa ALDESLEUKIN; BARIUM CARBONATE; CHASTE TREE; CHIMAPHILA UMBELLATA; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; DIGITALIS; FERRIC PICRATE; HUMAN INTERLEUKIN-10 (NONGLYCOSYLATED); INTERFERON GAMMA-1B; MELATONIN; SAW PALMETTO; SELENIUM; SUS SCROFA PROSTATE; THUJA OCCIDENTALIS TWIG; TRANSFORMING GROWTH FACTOR BETA-1; ZINC 4; 30; 6; 6; 3; 30; 30; 30; 30; 4; 4; 4; 3; 30; 200; 30; 4; 3 [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL 17089-347_f572ca8f-fcc7-4d50-aa94-0a23221478f5 17089-347 HUMAN OTC DRUG GUNA-HYPERTENSION ARNICA MONTANA - FUMARIC ACID - GOLD - LEAD - MELATONIN - MELILOTUS - OLEA EUROPAEA FLOWER - PORK KIDNEY - RAUWOLFIA SERPENTINA - SODIUM PYRUVATE - SPIGELIA - SUS SCROFA ADRENAL GLAND - SUS SCROFA DIE SOLUTION/ DROPS ORAL 20080416 UNAPPROVED HOMEOPATHIC Guna spa ARNICA MONTANA; FUMARIC ACID; GOLD; LEAD; MELATONIN; MELILOTUS; OLEA EUROPAEA FLOWER; PORK KIDNEY; RAUWOLFIA SERPENTINA; SODIUM PYRUVATE; SPIGELIA; SUS SCROFA ADRENAL GLAND; SUS SCROFA DIENCEPHALON; UBIDECARENONE; VISCUM ALBUM FRUIT 12; 3; 12; 12; 4; 6; 3; 6; 6; 3; 6; 200; 6; 3; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-348_6d62d1f8-a3e4-4d9f-83a6-fa9ce116d062 17089-348 HUMAN OTC DRUG GUNA-SPASM ATROPINE SULFATE - BERBERIS VULGARIS ROOT BARK - CHELIDONIUM MAJUS - COBALT - CULTIVATED MUSHROOM - GELSEMIUM SEMPERVIRENS ROOT - INTERLEUKIN-10 - MAGNESIUM - MELATONIN - METENKEFALIN - SUS SCROFA SYM SOLUTION/ DROPS ORAL 20080416 UNAPPROVED HOMEOPATHIC Guna spa ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ATROPINE SULFATE; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; COBALT; CULTIVATED MUSHROOM; GELSEMIUM SEMPERVIRENS ROOT; INTERLEUKIN-10; MAGNESIUM; MELATONIN; METENKEFALIN; SUS SCROFA SYMPATHETIC NERVE; SUS SCROFA VAGUS NERVE; WATERMELON 4; 6; 3; 4; 4; 4; 6; 4; 4; 4; 4; 200; 6; 4 [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-349_27ce5a7c-4174-4bf5-9c58-05f2bb74d09a 17089-349 HUMAN OTC DRUG GUNA-GERIATRICS 1,4-BENZOQUINONE - ARNICA MONTANA - OXYTOCIN - BARIUM CARBONATE - BARIUM OXALOSUCCINATE - CORTICOTROPIN - LEAD - LEVOTHYROXINE - LUTRELIN - MALIC ACID - MELATONIN - NEUROTROPHIN-3 - NEUROTROPHIN-4 - P SOLUTION/ DROPS ORAL 20080416 UNAPPROVED HOMEOPATHIC Guna spa 1,4-BENZOQUINONE; ARNICA MONTANA; BARIUM CARBONATE; BARIUM OXALOSUCCINATE; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; CORTICOTROPIN; LEAD; LEVOTHYROXINE; LUTRELIN; MALIC ACID; MELATONIN; NEUROTROPHIN-3; NEUROTROPHIN-4; OXYTOCIN; PHENYLALANINE; PORK LIVER; PYRUVIC ACID; RINFABATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA FRONTAL LOBE; SUS SCROFA HYPOTHALAMUS; THYROTROPIN ALFA 3; 6; 6; 3; 4; 6; 6; 6; 6; 3; 4; 4; 4; 6; 3; 6; 3; 4; 6; 6; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-350_29d041d6-96e1-4c0d-a94d-33618467c63d 17089-350 HUMAN OTC DRUG GUNA-AWARENESS BETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTRO SOLUTION/ DROPS ORAL 20080416 UNAPPROVED HOMEOPATHIC Guna spa BETAINE; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BUFO BUFO CUTANEOUS GLAND; CALCIUM CARBONATE; CHROMIC SULFATE; CICUTA VIROSA ROOT; COBALAMIN; COPPER; FOLIC ACID; GOLD; IRON; LACHESIS MUTA VENOM; MELATONIN; MOLYBDENUM; NEUROTROPHIN-3; NEUROTROPHIN-4; OXYTOCIN; SILICON DIOXIDE; SUS SCROFA FRONTAL LOBE; SUS SCROFA TEMPORAL LOBE; THYROTROPIN ALFA; UBIDECARENONE; VANADIUM; ZINC 3; 4; 12; 3; 3; 12; 3; 12; 3; 12; 3; 12; 4; 3; 4; 4; 6; 12; 6; 6; 3; 3; 6; 3 [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-359_a81d6d6e-1c06-447b-af8d-3b06f2c87ec5 17089-359 HUMAN PRESCRIPTION DRUG GUNA-Beta-ESTRADIOL ESTRADIOL SOLUTION/ DROPS ORAL 20081216 UNAPPROVED HOMEOPATHIC Guna spa ESTRADIOL 6 [hp_X]/30mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 17089-370_7063a3a8-3559-446a-bffd-13ee2eb30cf1 17089-370 HUMAN OTC DRUG GUNA-BDNF BRAIN-DERIVED NEUROTROPHIC FACTOR SOLUTION/ DROPS ORAL 20110331 UNAPPROVED HOMEOPATHIC Guna spa BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN 4 [hp_C]/30mL 17089-372_a5188106-8314-491c-a99d-45cb8a06f84e 17089-372 HUMAN OTC DRUG GUNA-EGF EPIDERMAL GROWTH FACTOR SOLUTION/ DROPS ORAL 20110331 UNAPPROVED HOMEOPATHIC Guna spa HUMAN EPIDERMAL GROWTH FACTOR 4 [hp_C]/30mL 17089-373_691f8684-b424-449a-9229-de2ae3cc9a50 17089-373 HUMAN OTC DRUG GUNA-FGF FIBROBLAST GROWTH FACTOR SOLUTION/ DROPS ORAL 20110331 UNAPPROVED HOMEOPATHIC Guna spa VELAFERMIN 4 [hp_C]/30mL 17089-375_a6da122b-13e5-4631-8109-c4c3528933e4 17089-375 HUMAN OTC DRUG GUNA-GCSF GRANULOCYTE COLONY STIMULATING FACTOR SOLUTION/ DROPS ORAL 20110331 UNAPPROVED HOMEOPATHIC Guna spa LENOGRASTIM 4 [hp_C]/30mL 17089-376_4a57751f-8fc6-417c-9065-12d4f919fb9d 17089-376 HUMAN OTC DRUG GUNA-IGF INSULIN-LIKE GROWTH FACTOR-1 SOLUTION/ DROPS ORAL 20110331 UNAPPROVED HOMEOPATHIC Guna spa MECASERMIN 4 [hp_C]/30mL 17089-378_ea0105cf-badd-4558-8404-e626f8e54bc3 17089-378 HUMAN OTC DRUG GUNA-INF GAMMA INTERFERON GAMMA-1B SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERFERON GAMMA-1B 4 [hp_C]/30mL 17089-380_b7483673-5095-45dd-aa14-99ced01acf0f 17089-380 HUMAN OTC DRUG GUNA-IL 2 ALDESLEUKIN SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa ALDESLEUKIN 4 [hp_C]/30mL 17089-381_fa342d07-0ca8-4d86-a78b-6afd6a024393 17089-381 HUMAN OTC DRUG GUNA-IL 3 INTERLEUKIN-3 SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-3 4 [hp_C]/30mL 17089-382_ec902a0e-7148-4d3f-bd00-da1926618736 17089-382 HUMAN OTC DRUG GUNA-IL 4 BINETRAKIN SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa BINETRAKIN 4 [hp_C]/30mL 17089-383_a7689b78-4dec-4280-8985-c228fc5972a4 17089-383 HUMAN OTC DRUG GUNA-IL 5 INTERLEUKIN-5 SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-5 4 [hp_C]/30mL 17089-384_476227d3-4b67-4273-8b61-9d0ef3edc39e 17089-384 HUMAN OTC DRUG GUNA-IL 6 INTERLEUKIN-6 SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-6 4 [hp_C]/30mL 17089-385_b0daef11-1480-49ba-92c4-984491d9ffcc 17089-385 HUMAN OTC DRUG GUNA-IL 7 INTERLEUKIN-7 SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-7 4 [hp_C]/30mL 17089-386_cbb51ffa-772d-4cc6-9f58-69c60c0862ad 17089-386 HUMAN OTC DRUG GUNA-IL 8 INTERLEUKIN-8 SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-8 4 [hp_C]/30mL 17089-387_1102e964-98be-412b-ad78-85dbb084cbb6 17089-387 HUMAN OTC DRUG GUNA-IL 9 INTERLEUKIN-9 SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-9 4 [hp_C]/30mL 17089-388_4405c502-6b75-4be9-9bdb-851344dfa0b1 17089-388 HUMAN OTC DRUG GUNA-IL 10 INTERLEUKIN-10 SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-10 4 [hp_C]/30mL 17089-389_503d0a06-2a91-4590-9367-c5b4c789773b 17089-389 HUMAN OTC DRUG GUNA-IL 11 INTERLEUKIN-11 SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-11 4 [hp_C]/30mL 17089-390_41f04aff-a3d1-4ce0-9e50-4b17f1617c4f 17089-390 HUMAN OTC DRUG GUNA-IL 12 INTERLEUKIN-12 HUMAN RECOMBINANT SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-12 HUMAN RECOMBINANT 4 [hp_C]/30mL 17089-395_af732ad2-8563-4e80-8a02-c3585c14cf70 17089-395 HUMAN OTC DRUG GUNA-TGF BETA 1 TRANSFORMING GROWTH FACTOR BETA 1 SOLUTION/ DROPS ORAL 20110331 UNAPPROVED HOMEOPATHIC Guna spa TRANSFORMING GROWTH FACTOR BETA-1 4 [hp_C]/30mL 17089-398_9056a1e0-543d-468a-ae9c-cb2cb3322823 17089-398 HUMAN OTC DRUG GUNA-ANTI IL 1 ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT- CANAKINUMAB SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; CANAKINUMAB 4; 4 [hp_C]/30mL; [hp_C]/30mL 17089-405_147412c4-d624-4d98-ac2b-b66db0b78839 17089-405 HUMAN OTC DRUG GAMMA -12 INTERLEUKIN-12 HUMAN RECOMBINANT - INTERFERON GAMMA-1B - SOLUTION/ DROPS ORAL 20100429 UNAPPROVED HOMEOPATHIC Guna spa INTERFERON GAMMA-1B; INTERLEUKIN-12 HUMAN RECOMBINANT 4; 4 [hp_C]/30mL; [hp_C]/30mL 17089-406_cad85703-cb8b-4387-97ef-3e50afd028a0 17089-406 HUMAN OTC DRUG GUNA-REFLUX ACTIVATED CHARCOAL - AETHUSA CYNAPIUM - APOMORPHINE HYDROCHLORIDE - BRYONIA ALBA ROOT - COLCHICUM AUTUMNALE BULB - IPECAC - LYCOPODIUM CLAVATUM SPORE - STRYCHNOS IGNATII SEED - STRYCHNOS NUX-VOMICA SE SOLUTION/ DROPS ORAL 20100512 UNAPPROVED HOMEOPATHIC Guna spa ACTIVATED CHARCOAL; AETHUSA CYNAPIUM; APOMORPHINE HYDROCHLORIDE; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ESOPHAGUS; SUS SCROFA STOMACH; WATERMELON 12; 4; 6; 30; 6; 4; 5; 6; 4; 10; 10; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-408_7b63ea98-d031-4283-92ba-b23dac5b98ea 17089-408 HUMAN OTC DRUG GUNA-VENUS ALETRIS FARINOSA ROOT - ALDESLEUKIN - ALPHA LIPOIC ACID - ATOSIBAN - CHASTE TREE - COBALAMIN - COPPER - CORTICOTROPIN - COTTON - CYCLAMEN PURPURASCENS TUBER - DOPAMINE - FOLIC ACID - FOLLICLE STIMULAT PELLET ORAL 20100427 UNAPPROVED HOMEOPATHIC Guna spa ALDESLEUKIN; ALETRIS FARINOSA ROOT; ALPHA LIPOIC ACID; ATOSIBAN; CHASTE TREE; COBALAMIN; COPPER; CORTICOTROPIN; CYCLAMEN PURPURASCENS TUBER; DOPAMINE; FOLIC ACID; FOLLICLE STIMULATING HORMONE BETA POLYPEPTIDE; HYDROQUINONE; LEVANT COTTON OIL; LUTRELIN; LUTROPIN ALFA; LYCOPODIUM CLAVATUM SPORE; PRASTERONE; SEPIA OFFICINALIS JUICE; SEROTONIN; SUCCINIC ACID; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; SUS SCROFA SPLEEN; TURNERA DIFFUSA TOP; ZINC 4; 4; 4; 6; 4; 4; 4; 6; 4; 6; 4; 6; 4; 4; 6; 6; 30; 6; 30; 6; 4; 6; 6; 6; 6; 4; 4 [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 17089-415_605a72af-0afc-40c7-8dac-f4b482d2aeab 17089-415 HUMAN OTC DRUG EUBIOFLOR ACTIVATED CHARCOAL - AETHUSA CYNAPIUM - ALTHAEA OFFICINALIS LEAF - BILBERRY - CANDIDA ALBICANS - UNCARIA TOMENTOSA - ESCHERICHIA COLI - INDOLE - MERCURIUS SOLUBILIS - OKOUBAKA AUBREVILLEI BARK - PORK SOLUTION/ DROPS ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa ACTIVATED CHARCOAL; AETHUSA CYNAPIUM; ALTHAEA OFFICINALIS LEAF; BILBERRY; CANDIDA ALBICANS; CAT'S CLAW; ESCHERICHIA COLI; INDOLE; MERCURIUS SOLUBILIS; OKOUBAKA AUBREVILLEI BARK; PORK LIVER; PROTEUS VULGARIS; SILYBUM MARIANUM SEED; SKATOLE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA COLON; SUS SCROFA GALL BLADDER; SUS SCROFA PANCREAS; TABEBUIA IMPETIGINOSA BARK; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOT 6; 6; 4; 4; 30; 4; 30; 12; 200; 6; 12; 12; 4; 30; 6; 30; 6; 12; 4; 4; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-416_3563b6ae-c94e-4620-a431-91d49e158784 17089-416 HUMAN OTC DRUG GUNA-MATRIX ASCORBIC ACID - DODECAHYDROXYCYCLOHEXANE DIHYDRATE - FUCUS VESICULOSUS - HISTIDINE MONOHYDROCHLORIDE - HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED) - HYALURONIDASE - LACTIC ACID, DL - MALIC ACID - NADIDE - P SOLUTION/ DROPS ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa ASCORBIC ACID; DODECAHYDROXYCYCLOHEXANE DIHYDRATE; FUCUS VESICULOSUS; HISTIDINE MONOHYDROCHLORIDE; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); HYALURONIDASE; LACTIC ACID, DL-; MALIC ACID; NADIDE; PHENYLALANINE; PRASTERONE; PROLACTIN; RANCID BEEF; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; SUS SCROFA CONJUNCTIVA; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; THUJA OCCIDENTALIS TWIG; TYROSINE 4; 6; 4; 4; 4; 6; 4; 6; 6; 4; 6; 6; 12; 6; 6; 12; 6; 6; 12; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-417_1d496774-7395-4864-8518-c669ab743c61 17089-417 HUMAN OTC DRUG GUNA-FLAM ACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENK SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ACONITUM NAPELLUS; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APIS MELLIFERA; ATROPA BELLADONNA; BASIC CUPRIC CARBONATE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CITRIC ACID MONOHYDRATE; FERRIC PHOSPHATE; INTERLEUKIN-10; MELATONIN; METENKEFALIN; PHYTOLACCA AMERICANA ROOT; RANCID BEEF; SODIUM PYRUVATE; SUS SCROFA CONJUNCTIVA; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; TRANSFORMING GROWTH FACTOR BETA-1 6; 4; 6; 6; 4; 6; 6; 3; 6; 4; 4; 6; 6; 30; 3; 12; 6; 200; 4 [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL 17089-418_7962d1bb-7762-422f-9440-f7d1223293a2 17089-418 HUMAN OTC DRUG GUNA-ALLERGY T AMMONIUM CARBONATE - APIS MELLIFERA - ARSENIC TRIOXIDE - BLATTA ORIENTALIS - CUPRIC ACETATE - DRIMIA MARITIMA BULB - EPINEPHRINE - GALPHIMIA GLAUCA FLOWERING TOP - HISTAMINE DIHYDROCHLORIDE - LUFFA OP SOLUTION/ DROPS ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa AMMONIUM CARBONATE; APIS MELLIFERA; ARSENIC TRIOXIDE; BLATTA ORIENTALIS; CUPRIC ACETATE; DRIMIA MARITIMA BULB; EPINEPHRINE; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; MANGANESE GLUCONATE; ONION; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA BRONCHUS; SUS SCROFA NASAL MUCOSA 30; 200; 30; 12; 30; 30; 6; 12; 200; 12; 4; 30; 30; 30; 12; 200; 200 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-419_7c1aea30-21bb-4b15-85da-caccc4b460e5 17089-419 HUMAN OTC DRUG GUNA-RHINO NOSE SPRAY APIS MELLIFERA - ARALIA RACEMOSA ROOT - ASCORBIC ACID - BLACK CURRANT - COPPER - EUPHORBIA RESINIFERA RESIN - EUROPEAN ELDERBERRY - HELIANTHEMUM CANADENSE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUK SPRAY ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa APIS MELLIFERA; ARALIA RACEMOSA ROOT; ASCORBIC ACID; BLACK CURRANT; COPPER; EUPHORBIA RESINIFERA RESIN; EUROPEAN ELDERBERRY; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; HUMAN INTERLEUKIN 12; HUMAN INTERLEUKIN-10 (NONGLYCOSYLATED); INTERFERON GAMMA-1B; MANGANESE GLUCONATE; MELILOTUS; ONION; PLANTAGO MAJOR; ROSA CANINA FRUIT; SILVER NITRATE 12; 1; 2; 1; 4; 4; 2; 4; 200; 4; 4; 4; 4; 3; 8; 2; 1; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-420_4903dff0-7854-4774-9651-82f0e31bf90b 17089-420 HUMAN OTC DRUG MICOX ASPERGILLUS NIGER VAR. NIGER - CANDIDA ALBICANS - CENTELLA ASIATICA - MALIC ACID - MERCURIC CHLORIDE - RHIZOPUS STOLONIFER - SODIUM DIETHYL OXALACETATE - SULFUR - TABEBUIA IMPETIGINOSA BARK - SOLUTION/ DROPS ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CENTELLA ASIATICA; MALIC ACID; MERCURIC CHLORIDE; RHIZOPUS STOLONIFER; SODIUM DIETHYL OXALACETATE; SULFUR; TABEBUIA IMPETIGINOSA BARK 30; 30; 6; 12; 6; 30; 12; 6; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-450_40b7699a-43f1-498e-80b0-a432142e78f9 17089-450 HUMAN OTC DRUG GUNA-CELL ACETYLCARNITINE, L-AMPc-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE- SOLUTION/ DROPS ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa .ALPHA.-TOCOPHEROL ACETATE, DL-; ACETYLCARNITINE, L-; ADENOSINE CYCLIC 3',5'-PHOSPHATE; ALPHA LIPOIC ACID; ASCORBIC ACID; CALCIUM CARBONATE; CITRIC ACID MONOHYDRATE; COBALAMIN; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; CUPRIC SULFATE; FERROUS FUMARATE; FOLIC ACID; FUMARIC ACID; HERRING SPERM DNA; MAGNESIUM PHOSPHATE; MANGANESE GLUCONATE; MANGANESE PHOSPHATE, DIBASIC; NIACIN; PANTOTHENIC ACID; PHOSPHORUS; PODOPHYLLUM PELTATUM ROOT; POTASSIUM ASPARTATE; PYRIDOXINE HYDROCHLORIDE; PYRUVALDEHYDE; RIBOFLAVIN; SACCHAROMYCES CEREVISIAE RNA; SELENOMETHIONINE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SULFUR; THIAMINE HYDROCHLORIDE; ZINC 3; 3; 6; 3; 3; 3; 3; 3; 6; 6; 3; 3; 3; 3; 6; 3; 3; 6; 3; 3; 4; 6; 3; 6; 10; 6; 6; 3; 3; 3; 3; 3; 4; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-451_39f21e73-19b6-484a-b11d-06db20f60af8 17089-451 HUMAN OTC DRUG GUNA-SINUS NOSE SPRAY ALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ON SPRAY ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa ALTHAEA OFFICINALIS LEAF; ASCORBIC ACID; BLACK CURRANT; CALCIUM SULFIDE; COPPER; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LACHESIS MUTA VENOM; LOBARIA PULMONARIA; MANGANESE; MERCURIC SULFIDE; ONION; PLANTAGO MAJOR; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SILVER NITRATE; SINUSITISINUM; SUS SCROFA NASAL MUCOSA; SUS SCROFA THYMUS; SUS SCROFA URINARY BLADDER 2; 2; 1; 8; 3; 3; 8; 30; 2; 3; 8; 8; 2; 8; 8; 8; 10; 30; 12; 12; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-452_01447aa9-556b-4ae9-aa89-f05f15a5f716 17089-452 HUMAN OTC DRUG GUNA-ORAL SPRAY ACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - SUS SCROFA TOOTH - SPRAY ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; CALCIUM SULFIDE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; HYPERICUM PERFORATUM; SUS SCROFA TOOTH; WITCH HAZEL 3; 3; 3; 4; 6; 6; 2; 2; 3; 12; 2 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 17089-453_954bfe17-6d04-4ed2-9a37-a212517107eb 17089-453 HUMAN OTC DRUG GUNA-COUGH ALTHAEA OFFICINALIS LEAF - ANTIMONY POTASSIUM TARTRATE - BRYONIA ALBA ROOT - CETRARIA ISLANDICA SUBSP. ISLANDICA - COCHINEAL - COPPER - DROSERA ROTUNDIFOLIA - ECHINACEA ANGUSTIFOLIA - GARDEN THYME - L SOLUTION/ DROPS ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa ALTHAEA OFFICINALIS LEAF; ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; CETRARIA ISLANDICA SUBSP. ISLANDICA; COCHINEAL; COPPER; DROSERA ROTUNDIFOLIA; ECHINACEA ANGUSTIFOLIA; LOBARIA PULMONARIA; PLANTAGO MAJOR; THYME 1; 8; 6; 4; 6; 8; 1; 1; 4; 1; 1 [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL 17089-454_be73d29d-36bb-4801-a8da-252cfe5d0882 17089-454 HUMAN OTC DRUG GUNA-MARS .ALPHA.-KETOGLUTARIC ACID - CHASTE TREE - CONIUM MACULATUM FLOWERING TOP - CORTICOTROPIN - DOPAMINE - FOLLITROPIN - GOLD - INTERLEUKIN-10 - LUTRELIN - LUTROPIN ALFA - LYCOPODIUM CLAVATUM SPORE - MALIC PELLET ORAL 20100818 UNAPPROVED HOMEOPATHIC Guna spa .ALPHA.-KETOGLUTARIC ACID; CHASTE TREE; CONIUM MACULATUM FLOWERING TOP; CORTICOTROPIN; DOPAMINE; FOLLITROPIN; GOLD; INTERLEUKIN-10; LUTRELIN; LUTROPIN ALFA; LYCOPODIUM CLAVATUM SPORE; MALIC ACID; OVEMOTIDE; POTASSIUM IODATE; PRASTERONE; PYRUVIC ACID; RINFABATE; SEROTONIN; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; SUS SCROFA SPLEEN; SUS SCROFA TESTICLE; SUS SCROFA URETHRA; SUS SCROFA VEIN; TURNERA DIFFUSA LEAFY TWIG; ZINC 4; 4; 4; 6; 6; 6; 6; 4; 6; 6; 30; 4; 6; 4; 6; 4; 4; 6; 6; 6; 6; 6; 6; 6; 4; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 17089-456_338b94d8-da07-4ebb-b464-6264883db1b1 17089-456 HUMAN OTC DRUG GUNA-INF ALPHA INTERFERON ALFA-2A SOLUTION/ DROPS ORAL 20110216 UNAPPROVED HOMEOPATHIC Guna spa INTERFERON ALFA-2A 4 [hp_C]/30mL 17089-458_073ce065-7db6-4289-92f2-255f7a0d3ca7 17089-458 HUMAN OTC DRUG GUNA-MELATONIN MELATONIN SOLUTION/ DROPS ORAL 20110523 UNAPPROVED HOMEOPATHIC Guna spa MELATONIN 4 [hp_C]/30mL 17089-459_8fd273af-ca0d-4c0c-9987-4d0ddee5c101 17089-459 HUMAN OTC DRUG GUNA-VTL ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT - CANAKINUMAB - BINETRAKIN - INTERLEUKIN-10 - METENKEFALIN SOLUTION/ DROPS ORAL 20141205 UNAPPROVED HOMEOPATHIC Guna spa ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; BINETRAKIN; CANAKINUMAB; INTERLEUKIN-10; METENKEFALIN 4; 4; 4; 4; 4 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL 17134-001_2d3b16b6-832a-4bf2-8b7b-d12f3c9834cf 17134-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19770101 UNAPPROVED MEDICAL GAS Roberts Home Medical, Inc. OXYGEN 990 mL/L 17139-613_61ef9c71-283d-49a3-87a1-c15b1feb3c34 17139-613 HUMAN PRESCRIPTION DRUG EstroGel estradiol GEL, METERED TRANSDERMAL 20040209 NDA NDA021166 ASCEND Therapeutics US, LLC ESTRADIOL .75 mg/1.25g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 17139-617_4f1f4c3d-1afd-43d3-9ba6-097879aa0332 17139-617 HUMAN PRESCRIPTION DRUG EstroGel estradiol GEL, METERED TRANSDERMAL 20040209 NDA NDA021166 ASCEND Therapeutics US, LLC ESTRADIOL .75 mg/1.25g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 17156-021_e5f8fb8d-3a5d-492b-9a1f-8e4e5cf595cf 17156-021 HUMAN PRESCRIPTION DRUG Indium in 111 Oxyquinoline Indium In-111 Oxyquinoline SOLUTION INTRAVENOUS 19851201 NDA NDA019044 Medi-Physics Inc. dba GE Healthcare. INDIUM IN-111 OXYQUINOLINE 1 ug/mL 17156-022_a947af02-e821-4d23-a66f-c4d61182d545 17156-022 HUMAN PRESCRIPTION DRUG CERETEC TECHNETIUM TC-99M EXAMETAZIME INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19881230 NDA NDA019829 Medi-Physics Inc. dba GE Healthcare. TECHNETIUM TC-99M EXAMETAZIME .5 mg/5mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 17156-023_a0ad9c36-5223-46cb-883d-3764a0689cd0 17156-023 HUMAN PRESCRIPTION DRUG Ceretec Exametazime KIT 19881230 NDA NDA019829 Medi-Physics Inc. 17156-024_2a8e565d-6c48-4ab2-a37d-fc924335d247 17156-024 HUMAN PRESCRIPTION DRUG Myoview Tetrofosmin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19960808 NDA NDA020372 Medi-Physics Inc. dba GE Healthcare TETROFOSMIN .23 mg/1 17156-026_50d759da-7183-428b-9512-2f0194fe9d7a 17156-026 HUMAN PRESCRIPTION DRUG Myoview Tetrofosmin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090226 NDA NDA020372 Medi-Physics Inc. dba GE Healthcare TETROFOSMIN 1.38 mg/1 17156-067_bd190e45-0860-4d4d-b2d7-f647fc3c4a9a 17156-067 HUMAN PRESCRIPTION DRUG Vizamyl Flutemetamol F-18 SOLUTION INTRAVENOUS 20140101 NDA NDA203137 Medi-Physics Inc. FLUTEMETAMOL F-18 4.05 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 17156-210_0c0c77fe-7b85-4d0a-a0d9-cfbeeddaf1fd 17156-210 HUMAN PRESCRIPTION DRUG DaTscan Ioflupane I-123 and iodine INJECTION, SOLUTION INTRAVENOUS 20110301 NDA NDA022454 Medi-Physics Inc. dba GE Healthcare. IODINE; IOFLUPANE I-123 2; .13 mCi/mL; ug/mL CII 17156-235_bf3ce582-7976-4708-be4d-4fb30c0336dd 17156-235 HUMAN PRESCRIPTION DRUG AdreView Iobenguane I-123 INJECTION INTRAVENOUS 20080919 NDA NDA022290 Medi-Physics Inc. IOBENGUANE I-123 2 mCi/mL 17156-523_596c20ff-b75c-4a19-aa23-fa8f738f4e59 17156-523 HUMAN PRESCRIPTION DRUG Indiclor Indium Chloride In-111 SOLUTION INTRAVENOUS 19921229 NDA NDA019862 Medi-Physics Inc. INDIUM CHLORIDE IN-111 5 mCi/.5mL 17156-524_493572ab-ae0f-498d-9f67-f17e90a75659 17156-524 HUMAN PRESCRIPTION DRUG Metastron Strontium Chloride Sr-89 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19930618 NDA NDA020134 Medi-Physics Inc. STRONTIUM CHLORIDE SR-89 1 mCi/mL Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA] 17156-601_531438d6-36af-45c8-a533-6ad02081a654 17156-601 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-602_531438d6-36af-45c8-a533-6ad02081a654 17156-602 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-603_531438d6-36af-45c8-a533-6ad02081a654 17156-603 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-604_531438d6-36af-45c8-a533-6ad02081a654 17156-604 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-605_531438d6-36af-45c8-a533-6ad02081a654 17156-605 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-606_531438d6-36af-45c8-a533-6ad02081a654 17156-606 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-607_531438d6-36af-45c8-a533-6ad02081a654 17156-607 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-608_531438d6-36af-45c8-a533-6ad02081a654 17156-608 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-609_531438d6-36af-45c8-a533-6ad02081a654 17156-609 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-610_531438d6-36af-45c8-a533-6ad02081a654 17156-610 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-611_531438d6-36af-45c8-a533-6ad02081a654 17156-611 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-612_531438d6-36af-45c8-a533-6ad02081a654 17156-612 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-613_531438d6-36af-45c8-a533-6ad02081a654 17156-613 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-614_531438d6-36af-45c8-a533-6ad02081a654 17156-614 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-615_531438d6-36af-45c8-a533-6ad02081a654 17156-615 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-616_531438d6-36af-45c8-a533-6ad02081a654 17156-616 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-617_531438d6-36af-45c8-a533-6ad02081a654 17156-617 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17156-618_531438d6-36af-45c8-a533-6ad02081a654 17156-618 HUMAN PRESCRIPTION DRUG Technetium Tc99m Generator TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. 17187-1061_40f261a0-17d6-4577-875a-c1e9ef4b5f04 17187-1061 HUMAN OTC DRUG DYNA-HEX 4 Chlorhexidine Gluconate SOLUTION TOPICAL 19851224 NDA NDA019125 Western Medical Corporation CHLORHEXIDINE GLUCONATE 4 g/100mL 17238-192_127a06af-170d-4fbf-82e9-d553fe667ae4 17238-192 HUMAN PRESCRIPTION DRUG Homatropine Homatropine Hydrobromide SOLUTION/ DROPS OPHTHALMIC 20120610 UNAPPROVED DRUG OTHER HUB Pharmaceuticals HOMATROPINE HYDROBROMIDE 50 mg/5mL Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 17238-193_a4b4b391-be81-467d-a0b7-451a32ae8a72 17238-193 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Ophthalmic Phenylephrine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20110101 UNAPPROVED DRUG OTHER HUB Pharmaceuticals, LLC PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 17238-520_7a0fc4af-72d7-4cce-8d82-a9c48bb5da8d 17238-520 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Ophthalmic Phenylephrine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20110101 UNAPPROVED DRUG OTHER HUB Pharmaceuticals, LLC PHENYLEPHRINE HYDROCHLORIDE 100 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 17238-610_daae390e-17de-41ca-9fca-b3c1e650f1f0 17238-610 HUMAN OTC DRUG Goniovisc Ophthalmic Lubricant Hypromellose 2910 (4000 MPA.S) SOLUTION/ DROPS OPHTHALMIC 20111110 OTC MONOGRAPH FINAL part349 HUB Pharmaceuticals, LLC HYPROMELLOSE 2910 (4000 MPA.S) 25 mg/mL 17238-625_416e4093-6b7e-4946-9acf-d1deb1fa2fba 17238-625 HUMAN OTC DRUG Sodium Chloride Sodium Chloride SOLUTION/ DROPS OPHTHALMIC 20130912 UNAPPROVED DRUG OTHER HUB Pharmaceuticals SODIUM CHLORIDE 50 mg/mL 17238-900_f0179ef4-cf7b-417e-a017-c5f8675dc6d5 17238-900 HUMAN PRESCRIPTION DRUG BioGlo Fluorescein Sodium STRIP OPHTHALMIC 20120401 UNAPPROVED DRUG OTHER HUB Pharmaceuticals, Inc. FLUORESCEIN SODIUM 1 mg/mg Diagnostic Dye [EPC],Dyes [MoA] 17238-910_2d156326-656f-4bde-9f9d-38bc0ea894df 17238-910 HUMAN PRESCRIPTION DRUG RoseGlo Rose Bengal STRIP OPHTHALMIC 20120401 UNAPPROVED DRUG OTHER HUB Pharmaceuticals, Inc. ROSE BENGAL SODIUM 1.5 mg/1.5mg 17238-920_3555928b-4678-4c2b-9d50-99a20f19015a 17238-920 HUMAN PRESCRIPTION DRUG GreenGlo Lissamine Green STRIP OPHTHALMIC 20120401 UNAPPROVED DRUG OTHER HUB Pharmaceuticals, Inc. LIGHT GREEN SF YELLOWISH 1.5 mg/1.5mg 17238-930_34bf4293-bc05-461f-9c67-18ee2a0f8b8e 17238-930 HUMAN PRESCRIPTION DRUG SoftGlo Large Molecule Fluorescein STRIP OPHTHALMIC 20120401 UNAPPROVED DRUG OTHER HUB Pharmaceuticals, Inc. OFTASCEINE .5 mg/.5mg 17270-503_401da24a-ec96-4435-9c45-a21939d92edd 17270-503 HUMAN OTC DRUG Primatene Mist Epinephrine INHALANT ORAL 19840523 ANDA ANDA087907 Armstrong Pharmaceuticals, Inc. EPINEPHRINE .22 mg/1 17270-504_401da24a-ec96-4435-9c45-a21939d92edd 17270-504 HUMAN OTC DRUG Primatene Mist Refill Epinephrine INHALANT ORAL 19840523 ANDA ANDA087907 Armstrong Pharmaceuticals, Inc. EPINEPHRINE .22 mg/1 17271-107_f40ae2ed-0e27-49aa-91d1-6b3a8e80998e 17271-107 HUMAN OTC DRUG BD E-Z Scrub 107 Chlorhexidine gluconate SOLUTION TOPICAL 20010910 ANDA ANDA072525 Becton Dickinson and Company CHLORHEXIDINE GLUCONATE 40 g/1000mL 17271-116_44fb59c1-002f-411d-a60c-c2197b5de41a 17271-116 HUMAN OTC DRUG BD E-Z Scrub Chloroxylenol SOLUTION TOPICAL 19890301 OTC MONOGRAPH NOT FINAL part333E Becton Dickinson and Company CHLOROXYLENOL 30 mg/mL 17271-205_45a9f803-1d30-4e0a-bead-e984d887ccb0 17271-205 HUMAN OTC DRUG BD E-Z Scrub Povidone-Iodine SOLUTION TOPICAL 19950601 OTC MONOGRAPH NOT FINAL part333E Becton Dickinson and Company POVIDONE-IODINE 100 mg/mL 17271-245_866675bf-963c-44e4-8a4b-0ab4262b3c6f 17271-245 HUMAN OTC DRUG BD E-Z Scrub Povidone-Iodine SOLUTION TOPICAL 19950601 OTC MONOGRAPH NOT FINAL part333E Becton Dickinson and Company POVIDONE-IODINE 50 mg/mL 17271-408_f328da25-3b2a-4c6e-8bc8-11e929bb989b 17271-408 HUMAN OTC DRUG BD E-Z Scrub Choroxylenol SOLUTION TOPICAL 19920701 OTC MONOGRAPH NOT FINAL part333E Becton Dickinson and Company CHLOROXYLENOL 30 mg/mL 17271-501_ddd9d67c-6ab3-4ed8-87c6-82a67e8e9f64 17271-501 HUMAN OTC DRUG BD E-Z Care Alcohol SOLUTION TOPICAL 20040401 OTC MONOGRAPH NOT FINAL part333E Becton Dickinson and Company ALCOHOL 600 mg/mL 17271-502_4bfad818-5c24-4c71-a70c-9985d54c1a97 17271-502 HUMAN OTC DRUG BD E-Z Scrub Chloroxylenol SOLUTION TOPICAL 20000401 OTC MONOGRAPH NOT FINAL part333E Becton Dickinson and Company CHLOROXYLENOL 30 mg/mL 17271-503_ca453bcb-24a4-4226-8f89-8dd67b46a0d4 17271-503 HUMAN OTC DRUG BD E-Z Scrub Povidone-Iodine SOLUTION TOPICAL 20000401 OTC MONOGRAPH NOT FINAL part333E Becton Dickinson and Company POVIDONE-IODINE 50 mg/mL 17271-505_04eda488-5e96-42a7-807a-51cd9ddc75e4 17271-505 HUMAN OTC DRUG BD E-Z Scrub chlorhexidine gluconate SOLUTION TOPICAL 20060101 NDA NDA019127 Becton Dickinson and Company CHLORHEXIDINE GLUCONATE 40 g/1000mL 17271-506_bb6264b8-7f17-48b4-aa28-24d88018248c 17271-506 HUMAN OTC DRUG BD E-Z Scrub chlorhexidine gluconate SOLUTION TOPICAL 20010401 NDA NDA019422 Becton Dickinson and Company CHLORHEXIDINE GLUCONATE 20 mg/mL 17271-507_75c8db6f-f2a0-46fc-bf95-1980f7b027c9 17271-507 HUMAN OTC DRUG BD Persist povidone-iodine, alcohol SOLUTION TOPICAL 19960221 OTC MONOGRAPH NOT FINAL part333A Becton Dickinson Infusion Therapy Systems Inc. ALCOHOL; POVIDONE-IODINE 65; 85 mg/mL; mg/mL 17312-001_458aa6ef-9d65-4a5a-bb9a-72bba2d72598 17312-001 HUMAN OTC DRUG Ring Relief Arnica Montana, Calcium Sulfide, Hypericum Perforatum, Lycopodium Clavatum Spore, Thiosinaminum, Mercurius Solubilis, Salicylic Acid, Silicon Dioxide, Allylthiourea LIQUID AURICULAR (OTIC) 20060601 UNAPPROVED HOMEOPATHIC TRP Company ALLYLTHIOUREA; ARNICA MONTANA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SALICYLIC ACID; SILICON DIOXIDE 6; 6; 13; 6; 12; 13; 6; 13 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 17312-002_b88c6773-5097-4095-acf9-96ad977a8e32 17312-002 HUMAN OTC DRUG Blur Relief Jacobaea Maritima, Calcium Fluoride, Conium Maculatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, Sodium Chloride, Ruta Graveolens Flowering Top LIQUID INTRAOCULAR 20060601 UNAPPROVED HOMEOPATHIC TRP Company CALCIUM FLUORIDE; CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; JACOBAEA MARITIMA; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE 13; 6; 6; 6; 5; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 17312-003_747751c1-49c6-499c-9f28-93806138de11 17312-003 HUMAN OTC DRUG Ring Relief Potassium Sulfate, Salicylic Acid, Silicon Dioxide, Calcium Sulfate Anhydrous, Quinine Sulfate, Allylthiourea TABLET, MULTILAYER ORAL 20060601 UNAPPROVED HOMEOPATHIC TRP Company ALLYLTHIOUREA; ASCORBIC ACID; BIOTIN; CALCIUM SULFATE ANHYDROUS; CITRUS BIOFLAVONOIDS; CYANOCOBALAMIN; FOLIC ACID; GINKGO; INOSITOL; NIACINAMIDE; PANTOTHENIC ACID; POTASSIUM SULFATE; PYRIDOXINE; QUININE SULFATE; RIBOFLAVIN; SALICYLIC ACID; SILICON DIOXIDE; THIAMINE; ZINC PICOLINATE 6; 150; 100; 6; 300; 200; 200; 30; 37.5; 10; 2.5; 6; .5; 12; .5; 6; 6; .5; 7.5 [hp_X]/1; mg/1; ug/1; [hp_X]/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; [hp_X]/1; mg/1; [hp_X]/1; mg/1; [hp_X]/1; [hp_X]/1; mg/1; mg/1 17312-004_dcbfff46-0e86-46be-b01e-b6bf9bf639ba 17312-004 HUMAN OTC DRUG Temporary Fibromyalgia Pain and Discomfort Relief Aconitum Napellus, Atropa Belladonna, Causticum, Magnesium Phosphate, Dibasic, Strychnos Nux-Vomica Seed, Toxicodendron Pubescens Leaf TABLET, MULTILAYER ORAL 20100201 UNAPPROVED HOMEOPATHIC TRP Company ACONITUM NAPELLUS; ATROPA BELLADONNA; BIOTIN; CALCIUM PANTOTHENATE; CAUSTICUM; CYANOCOBALAMIN; FOLIC ACID; MAGNESIUM ASCORBATE; MAGNESIUM ASCORBATE; MAGNESIUM OXIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SEDUM ROSEUM ROOT; SELENIUM; STRYCHNOS NUX-VOMICA SEED; THIAMINE HYDROCHLORIDE; TOXICODENDRON PUBESCENS LEAF 6; 6; 200; 5; 6; 400; 400; 200; 75; 75; 6; 20; 1; 1; 200; 100; 6; 1; 6 [hp_C]/1; [hp_C]/1; ug/1; mg/1; [hp_C]/1; ug/1; ug/1; mg/1; mg/1; mg/1; [hp_C]/1; mg/1; mg/1; mg/1; mg/1; ug/1; [hp_C]/1; mg/1; [hp_C]/1 17312-013_51c912f6-d34a-4f0f-88c0-c31b8f5840b9 17312-013 HUMAN OTC DRUG Pink Eye Relief ACONITUM NAPELLUS - APIS MELLIFERA - SILVER NITRATE - EUPHRASIA STRICTA - SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE - LIQUID AURICULAR (OTIC) 20120901 UNAPPROVED HOMEOPATHIC TRP Company ACONITUM NAPELLUS; APIS MELLIFERA; EUPHRASIA STRICTA; SILVER NITRATE; SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE 6; 6; 6; 12; 11 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 17312-014_0b1fc3e5-a4ed-4693-8193-243cb57e8a13 17312-014 HUMAN OTC DRUG Stye Relief APIS MELLIFERA - CARBON DISULFIDE - PULSATILLA VULGARIS - SILICON DIOXIDE - DELPHINIUM STAPHISAGRIA SEED - OINTMENT TOPICAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company APIS MELLIFERA; CARBON DISULFIDE; DELPHINIUM STAPHISAGRIA SEED; PULSATILLA VULGARIS; SILICON DIOXIDE 6; 6; 6; 6; 6 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 17312-015_e09d6756-b5e0-43b6-90e4-aa1110c435cf 17312-015 HUMAN OTC DRUG Ring Relief ARNICA MONTANA - CALCIUM SULFIDE - HYPERICUM PERFORATUM - LYCOPODIUM CLAVATUM SPORE - MERCURIUS SOLUBILIS - SALICYLIC ACID - SILICON DIOXIDE - ALLYLTHIOUREA - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ALLYLTHIOUREA; ARNICA MONTANA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SALICYLIC ACID; SILICON DIOXIDE 6; 6; 13; 6; 12; 13; 6; 13 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 17312-016_ee01e9ed-d097-4c81-868d-302c2876e8ff 17312-016 HUMAN OTC DRUG Temporary Fibromyalgia Pain and Discomfort Relief ATROPA BELLADONNA - BRYONIA ALBA ROOT - CAUSTICUM - PHOSPHORUS - STRYCHNOS NUX-VOMICA SEED - PULSATILLA VULGARIS - TOXICODENDRON PUBESCENS LEAF - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAUSTICUM; PHOSPHORUS; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 17312-017_30283f2a-23ad-4ad0-a11a-48fc4a3deca8 17312-017 HUMAN OTC DRUG Asthma Therapy ARSENIC TRIOXIDE - HISTAMINE DIHYDROCHLORIDE - DERMATOPHAGOIDES PTERONYSSINUS - MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - STRYCHNOS NUX-VOMICA SEED - ASPIDOSPERMA QUEBRACHO-BLANCO BARK - SUPLHUR - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ARSENIC TRIOXIDE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; DERMATOPHAGOIDES PTERONYSSINUS; HISTAMINE DIHYDROCHLORIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; SULFUR 6; 6; 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 17312-018_14c0c65f-cd47-425c-bba5-faf3f2b5770d 17312-018 HUMAN OTC DRUG Bronchial Cough Therapy ANTIMONY POTASSIUM TARTRATE - PROTORTONIA CACTI - DROSERA ROTUNDIFOLIA - ECHINACEA, UNSPECIFIED - CALCIUM SULFIDE - HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED - SPONGIA OFFICINALIS SKELETON, ROASTED - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ANTIMONY POTASSIUM TARTRATE; CALCIUM SULFIDE; DROSERA ROTUNDIFOLIA; ECHINACEA, UNSPECIFIED; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; PROTORTONIA CACTI; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 6; 6; 6; 18; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 17312-019_76c3893b-0c75-4ac3-a6f1-a4bfc7437176 17312-019 HUMAN OTC DRUG Irritable Bowel Syndrome Therapy ASAFETIDA - BISMUTH SUBNITRATE - BRYONIA ALBA ROOT - ACTIVATED CHARCOAL - LYCOPODIUM CLAVATUM SPORE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - VERATRUM ALBUM ROOT - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ACTIVATED CHARCOAL; ASAFETIDA; BISMUTH SUBNITRATE; BRYONIA ALBA ROOT; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 6; 3; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 17312-020_e17019f3-d2e9-4920-b6ca-985a89f5e6bf 17312-020 HUMAN OTC DRUG Chronic Fatigue Therapy EPINEPHRINE - GOLD - HUMAN BREAST TUMOR CELL - ECHINACEA, UNSPECIFIED - GELSEMIUM SEMPERVIRENS ROOT - GINKGO - INFLUENZA B VIRUS - PHOSPHORIC ACID - SCUTELLARIA LATERIFLORA TOP - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ECHINACEA, UNSPECIFIED; EPINEPHRINE; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; GOLD; HUMAN BREAST TUMOR CELL; INFLUENZA B VIRUS; PHOSPHORIC ACID; SCUTELLARIA LATERIFLORA TOP 3; 3; 6; 3; 8; 24; 12; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 17312-021_1dee4d65-8c4e-46bc-ab4a-0bd6465e80d0 17312-021 HUMAN OTC DRUG Sciatica Therapy ARNICA MONTANA - CITRULLUS COLOCYNTHIS FRUIT PULP - PSEUDOGNAPHALIUM OBTUSIFOLIUM - HYPERICUM PERFORATUM - POTASSIUM IODIDE - MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - TOXICODENDRON PUBESCENS LEAF - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ARNICA MONTANA; CITRULLUS COLOCYNTHIS FRUIT PULP; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM IODIDE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 17312-022_6b682fed-90b0-49c0-b3a0-556568bc68cb 17312-022 HUMAN OTC DRUG Migraine Headache Therapy ATROPA BELLADONNA - BRYONIA ALBA ROOT - BLACK COHOSH - ARABICA COFFEE BEAN - NITROGLYCERIN - IRIS VERSICOLOR ROOT - SODIUM CHLORIDE - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ARABICA COFFEE BEAN; ATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; IRIS VERSICOLOR ROOT; NITROGLYCERIN; SODIUM CHLORIDE 3; 6; 6; 6; 6; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 17312-023_4d67cc9b-9d2d-4534-b80e-169ea7a8b4da 17312-023 HUMAN OTC DRUG Ring Relief ARNICA MONTANA - CALCIUM SULFIDE - HYPERICUM PERFORATUM - LYCOPODIUM CLAVATUM SPORE - MERCURIUS SOLUBILIS - SALICYLIC ACID - SILICON DIOXIDE - ALLYLTHIOUREA - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ALLYLTHIOUREA; ARNICA MONTANA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SALICYLIC ACID; SILICON DIOXIDE 6; 6; 13; 6; 12; 13; 6; 13 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 17312-024_4331d36d-2f6b-4a45-a6ce-d18eb24f76de 17312-024 HUMAN OTC DRUG Pink Eye ACONITUM NAPELLUS - APIS MELLIFERA - SILVER NITRATE - EUPHRASIA STRICTA - SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE - LIQUID INTRAOCULAR 20120901 UNAPPROVED HOMEOPATHIC TRP Company ACONITUM NAPELLUS; APIS MELLIFERA; EUPHRASIA STRICTA; SILVER NITRATE; SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE 6; 6; 6; 12; 11 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 17312-025_364cacd5-cad9-4727-9815-b7a6bd9161ab 17312-025 HUMAN OTC DRUG EarAche Therapy APIS MELLIFERA, ARNICA MONTANA, ATROPA BELLADONNA, TRIBASIC CALCIUM PHOSPHATE, ECHINACEA, UNSPECIFIED, CALCIUM SULFIDE, MERCURIUS SOLUBILIS TABLET, ORALLY DISINTEGRATING ORAL 20130905 UNAPPROVED HOMEOPATHIC TRP Company APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; MERCURIUS SOLUBILIS; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6; 6; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 17312-026_45256b30-fcdd-4c14-a9af-6e6c119899fc 17312-026 HUMAN OTC DRUG Arthritis Therapy APIS MELLIFERA, BRYONIA ALBA ROOT, CALCIUM FLUORIDE, LITHIUM CARBONATE, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, SALICYLIC ACID TABLET, ORALLY DISINTEGRATING ORAL 20130905 UNAPPROVED HOMEOPATHIC TRP Company APIS MELLIFERA; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; LITHIUM CARBONATE; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 17312-027_e23e6c90-094a-4739-9459-293e6fcc1b2a 17312-027 HUMAN OTC DRUG AgingEye Relief TRIBASIC CALCIUM PHOSPHATE, CALENDULA OFFICINALIS FLOWERING TOP, CARBON DISULFIDE, JACOBAEA MARITIMA, CONIUM MACULATUM FLOWERING TOP, EUPHRASIA STRICTA, SELENIUM, ZINC LIQUID OPHTHALMIC 20140501 UNAPPROVED HOMEOPATHIC TRP Company CALENDULA OFFICINALIS FLOWERING TOP; CARBON DISULFIDE; CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; JACOBAEA MARITIMA; SELENIUM; TRIBASIC CALCIUM PHOSPHATE; ZINC 3; 6; 6; 6; 5; 12; 13; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 17350-015_fc3a7ee0-5684-11e2-a894-0002a5d5c51b 17350-015 HUMAN PRESCRIPTION DRUG Rescula Unoprostone Isopropyl SOLUTION/ DROPS OPHTHALMIC 20130107 NDA NDA021214 Sucampo Pharma Americas, LLC UNOPROSTONE ISOPROPYL 1.5 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 17420-0036_672e338c-49a8-479b-9403-9e354b085aec 17420-0036 HUMAN OTC DRUG Utom 40 Number 36 SEPIA OFFICINALIS JUICE, CONIUM MACULATUM FLOWERING TOP, THUJA OCCIDENTALIS LEAFY TWIG TABLET ORAL 20110420 UNAPPROVED HOMEOPATHIC P. Banerji Mihijam Pharmaceuticals CONIUM MACULATUM FLOWERING TOP; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 3; 200; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 17420-1008_08718ab0-765a-63c4-e054-00144ff8d46c 17420-1008 HUMAN OTC DRUG Arnica montana 3C Arnica montana PELLET ORAL 20141122 UNAPPROVED HOMEOPATHIC P. Banerji Mihijam Pharmaceuticals ARNICA MONTANA 3 [hp_C]/1 17429-010_7b1f8c97-aaeb-460d-8882-ba19adb9c76e 17429-010 HUMAN OTC DRUG Yat Tip Xiao External Analgesic Plaster for Removal of Corns and Calluses PLASTER TOPICAL 19770101 OTC MONOGRAPH FINAL part348 Huangshi Hygenic Material Pharmacy Co. Ltd. PHENOL; SALICYLIC ACID 40; 780 mg/1; mg/1 17433-9876_4d7ab8a4-f84a-4e47-a104-ca0e3d7f6785 17433-9876 HUMAN OTC DRUG ENEMEEZ DOCUSATE SODIUM LIQUID RECTAL 20120615 OTC MONOGRAPH NOT FINAL part334 Enemeez Inc. DBA Summit Pharmaceuticals DOCUSATE SODIUM 283 mg/5mL 17433-9877_a385116f-e477-4960-b91e-c15a558ba5d0 17433-9877 HUMAN OTC DRUG ENEMEEZ Plus DOCUSATE SODIUM and BENZOCAINE LIQUID RECTAL 20120615 OTC MONOGRAPH NOT FINAL part334 Enemeez Inc. DBA Summit Pharmaceuticals BENZOCAINE; DOCUSATE SODIUM 20; 283 mg/5mL; mg/5mL 17433-9878_2a1d1169-b293-4707-be8e-2fb90644e5f2 17433-9878 HUMAN OTC DRUG Docusol docusate sodium LIQUID RECTAL 20130708 OTC MONOGRAPH NOT FINAL part334 Enemeez Inc. DBA Summit Pharmaceuticals DOCUSATE SODIUM 283 mg/5mL 17433-9882_9e65c091-d567-43a0-9c35-4f01a91bff8b 17433-9882 HUMAN OTC DRUG Enemeez Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130729 OTC MONOGRAPH NOT FINAL part334 Enemeez Inc. DOCUSATE SODIUM 100 mg/1 17433-9883_05f5eb41-83d7-4549-e054-00144ff8d46c 17433-9883 HUMAN OTC DRUG Docusol Plus docusate sodium w/benzocaine LIQUID RECTAL 20130712 OTC MONOGRAPH NOT FINAL part334 Enemeez Inc. DBA Summit Pharmaceuticals BENZOCAINE; DOCUSATE SODIUM 20; 283 mg/5mL; mg/5mL 17433-9884_b1a53f5b-b2b7-45df-bb9a-f68d5e6b77bc 17433-9884 HUMAN OTC DRUG Docusol Kids docusate sodium LIQUID RECTAL 20140114 OTC MONOGRAPH NOT FINAL part334 Enemeez Inc. DBA Summit Pharmaceuticals DOCUSATE SODIUM 100 mg/5mL 17433-9990_0738b141-22b0-06a4-e054-00144ff88e88 17433-9990 HUMAN OTC DRUG CVS Kids Mini Enema docusate sodium LIQUID RECTAL 20141115 OTC MONOGRAPH NOT FINAL part334 Summit Pharmaceuticals DOCUSATE SODIUM 100 mg/5mL 17433-9991_06fcb36c-9096-6f84-e054-00144ff8d46c 17433-9991 HUMAN OTC DRUG CVS Adult Enema docusate sodium w/benzocaine LIQUID RECTAL 20140901 OTC MONOGRAPH NOT FINAL part334 Summit Pharmaceuticals BENZOCAINE; DOCUSATE SODIUM 20; 283 mg/4.6g; mg/4.6g 17452-360_c131edbc-8f71-4da5-9029-68405eb218e9 17452-360 HUMAN OTC DRUG MDSolarSciences SPF40 Ultra-Sport Meradimate and Octisalate and Octocrylene and Titanium Dioxide and Zinc Oxide STICK TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Ecometics, Inc MERADIMATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE .35; .35; 1; .135; 1.025 g/10g; g/10g; g/10g; g/10g; g/10g 17452-370_26e47ef7-264d-4664-b54c-d67483b0a0e4 17452-370 HUMAN OTC DRUG MDSolarSciences SPF40 No Touch Body Avobenzone and Octisalate and Octocrylene SPRAY TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Ecometics, Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 2.75 g/100mL; g/100mL; g/100mL 17452-380_f1e2b580-adac-4eb6-b736-0cfb31f8326b 17452-380 HUMAN OTC DRUG MDSolarSciences SPF50 Plus Ultra Mineral Screen Titanium Dioxide and Zinc Oxide GEL TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Ecometics, Inc TITANIUM DIOXIDE; ZINC OXIDE 10.3; 5.5 g/100g; g/100g 17452-390_e0762b81-4af2-4c37-9bb6-76a1b0b21a3f 17452-390 HUMAN OTC DRUG MDSolarSciences SPF30 Plus Mineral Screen Titanium Dioxide and Zinc Oxide GEL TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Ecometics, Inc TITANIUM DIOXIDE; ZINC OXIDE 7.7; 3.8 g/100g; g/100g 17452-400_3a8fe4da-d828-4e57-96a6-4bbc0d99e514 17452-400 HUMAN OTC DRUG MDSolarSciences SPF40 Mineral Screen Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Ecometics, Inc TITANIUM DIOXIDE; ZINC OXIDE 7.7; 3.8 g/100g; g/100g 17452-430_bf08608c-f821-4594-8d03-de3f59c5521c 17452-430 HUMAN OTC DRUG Dr. OH BALM CAMPHOR, CAPSAICIN and MENTHOL CREAM TOPICAL 20120423 OTC MONOGRAPH NOT FINAL part348 Ecometics, Inc. CAMPHOR (SYNTHETIC); CAPSAICIN; MENTHOL 3.5; .015; 1 g/100g; g/100g; g/100g 17478-010_8496ebbf-5ea5-46de-b4a5-74d334d77ba7 17478-010 HUMAN PRESCRIPTION DRUG Inapsine Droperidol INJECTION INTRAMUSCULAR; INTRAVENOUS 19960701 NDA NDA016796 Akorn, Inc. DROPERIDOL 2.5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 17478-012_6e1fda58-f044-45d1-a74a-fbf8e88f7c73 17478-012 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20120808 NDA AUTHORIZED GENERIC NDA012015 Akorn, Inc. BENZTROPINE MESYLATE 1 mg/mL Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 17478-030_5a4b84d2-0743-4974-9982-7c114d2af4e9 17478-030 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE FENTANYL CITRATE INJECTION INTRAMUSCULAR; INTRAVENOUS 20120322 NDA NDA016619 Akorn, Inc. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 17478-040_91e1b3ef-772c-40d2-9c49-12f4d044665c 17478-040 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR 19800701 ANDA ANDA075025 Akorn, Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 17478-045_ee2a9b04-7c88-4c8d-8a55-d8ca73e03b59 17478-045 HUMAN PRESCRIPTION DRUG Tetracaine Tetracaine HCl INJECTION SUBARACHNOID 20100601 UNAPPROVED DRUG OTHER Akorn, Inc. TETRACAINE HYDROCHLORIDE 10 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 17478-050_2a04386e-0c3d-4ece-be52-9bacf649ded4 17478-050 HUMAN PRESCRIPTION DRUG Sufentanil Citrate Sufentanil Citrate INJECTION EPIDURAL; INTRAVENOUS 20101201 NDA NDA019050 Akorn, Inc. SUFENTANIL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 17478-055_aa45e3c4-f89a-4f60-af33-16539c7dc405 17478-055 HUMAN PRESCRIPTION DRUG Dexmedetomidine Dexmedetomidine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20141124 ANDA ANDA202585 Akorn, Inc. DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] 17478-060_bdc9fa91-6413-4920-a6dd-f6e089788370 17478-060 HUMAN OTC DRUG Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 19980301 OTC MONOGRAPH FINAL part349 Akorn, Inc. POLYVINYL ALCOHOL 14 mg/mL 17478-062_a8145a3b-1d31-4069-974a-c81998336cb1 17478-062 HUMAN OTC DRUG Artificial Tears Mineral Oil and Petrolatum OINTMENT OPHTHALMIC 19900901 OTC MONOGRAPH FINAL part349 Akorn, Inc. MINERAL OIL; PETROLATUM 150; 830 mg/g; mg/g 17478-063_1b32e063-96e1-489b-9638-466ea56afc63 17478-063 HUMAN OTC DRUG Lubricant Eye Mineral Oil and Petrolatum OINTMENT OPHTHALMIC 19930401 OTC MONOGRAPH FINAL part349 Akorn, Inc. MINERAL OIL; PETROLATUM 120; 880 mg/g; mg/g 17478-064_0bf13d29-b5ce-4a34-a6a5-4883a13487b1 17478-064 HUMAN PRESCRIPTION DRUG Gonak Hypromellose Hypromellose 2906 (4000 MPA.S) and Hypromellose 2906 (50 MPA.S) SOLUTION OPHTHALMIC 19970101 UNAPPROVED DRUG OTHER Akorn, Inc. HYPROMELLOSE 2906 (4000 MPA.S); HYPROMELLOSE 2906 (50 MPA.S) 25; 25 mg/mL; mg/mL 17478-065_d13209d6-46d4-41b7-9fc6-4c2bbc8882dd 17478-065 HUMAN OTC DRUG Naphazoline Hydrochloride and Pheniramine Maleate Naphazoline Hydrochloride and Pheniramine Maleate SOLUTION/ DROPS OPHTHALMIC 20130124 ANDA ANDA202795 Akorn, Inc. NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .25; 3 mg/mL; mg/mL 17478-066_9496f818-72c7-400f-a6ee-77c851f0d320 17478-066 HUMAN PRESCRIPTION DRUG Nedocromil Sodium Nedocromil Sodium SOLUTION/ DROPS OPHTHALMIC 20120910 ANDA ANDA090638 Akorn, Inc. NEDOCROMIL SODIUM 20 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] 17478-067_5a801d7f-566f-4c16-ae95-55cc2ed81e72 17478-067 HUMAN PRESCRIPTION DRUG Alfenta Alfentanil hydrochloride INJECTION INTRAVENOUS 20100201 NDA NDA019353 Akorn ALFENTANIL HYDROCHLORIDE 500 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 17478-069_32922883-4490-4c2f-b0df-8738dc748eb1 17478-069 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121108 ANDA ANDA079197 Akorn, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 17478-070_8003f107-a779-4404-9ca4-cb37ec13e81f 17478-070 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19960718 ANDA ANDA064030 Akorn, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 17478-080_2b14f1a3-f8d6-45e8-a31a-89dc25d5c7f8 17478-080 HUMAN PRESCRIPTION DRUG CAPASTAT SULFATE Capreomycin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090801 NDA NDA050095 Akorn CAPREOMYCIN SULFATE 1 g/1 Antimycobacterial [EPC] 17478-097_09161d72-515d-4ab3-9eca-7f492cc37fd1 17478-097 HUMAN PRESCRIPTION DRUG Cyclopentolate Hydrochloride Cyclopentolate Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19970113 ANDA ANDA040165 Akorn, Inc. CYCLOPENTOLATE HYDROCHLORIDE 20 mg/mL 17478-100_09161d72-515d-4ab3-9eca-7f492cc37fd1 17478-100 HUMAN PRESCRIPTION DRUG Cyclopentolate Hydrochloride Cyclopentolate Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19970113 ANDA ANDA040164 Akorn, Inc. CYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL 17478-101_00d4ae88-8439-46b6-9935-5fb3fa5213fa 17478-101 HUMAN PRESCRIPTION DRUG Tropicamide Tropicamide SOLUTION/ DROPS OPHTHALMIC 20000929 ANDA ANDA040314 Akorn, Inc. TROPICAMIDE 5 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 17478-102_00d4ae88-8439-46b6-9935-5fb3fa5213fa 17478-102 HUMAN PRESCRIPTION DRUG Tropicamide Tropicamide SOLUTION/ DROPS OPHTHALMIC 20000929 ANDA ANDA040315 Akorn, Inc. TROPICAMIDE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 17478-106_b18b5d2a-15c7-4701-8c5c-bee2fe1a18d1 17478-106 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin SOLUTION OPHTHALMIC 20110301 ANDA ANDA090268 Akorn Inc. LEVOFLOXACIN 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 17478-107_cd20454b-b46c-43e8-85ea-4d96fe740d73 17478-107 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION INTRAVENOUS 20110701 ANDA ANDA091644 Akorn, Inc. LEVOFLOXACIN 25 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 17478-114_46f012c3-b6fa-40ce-86ce-320ceb3e84c8 17478-114 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140916 ANDA ANDA205179 Akorn, Inc. TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 17478-120_4b58b993-b9e5-4a3f-88c2-8c1a084fa7fb 17478-120 HUMAN PRESCRIPTION DRUG Clindamycin Clindamycin Phosphate INJECTION INTRAVENOUS 20130405 ANDA ANDA203048 Akorn, Inc. CLINDAMYCIN PHOSPHATE 300 mg/50mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 17478-121_4b58b993-b9e5-4a3f-88c2-8c1a084fa7fb 17478-121 HUMAN PRESCRIPTION DRUG Clindamycin Clindamycin Phosphate INJECTION INTRAVENOUS 20130405 ANDA ANDA203048 Akorn, Inc. CLINDAMYCIN PHOSPHATE 600 mg/50mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 17478-122_4b58b993-b9e5-4a3f-88c2-8c1a084fa7fb 17478-122 HUMAN PRESCRIPTION DRUG Clindamycin Clindamycin Phosphate INJECTION INTRAVENOUS 20130405 ANDA ANDA203048 Akorn, Inc. CLINDAMYCIN PHOSPHATE 900 mg/50mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 17478-131_6d8a5748-ec3d-4a1b-a7b1-ce54ba397a30 17478-131 VACCINE Tetanus and Diphtheria Toxoids Adsorbed Tetanus and Diphtheria Toxoids Adsorbed INJECTION INTRAMUSCULAR 19700727 BLA BLA101322 Akorn, Inc. CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2; 2 [Lf]/.5mL; [Lf]/.5mL Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient] 17478-151_98e1676c-27db-45bc-a592-dc16d19e3e8a 17478-151 HUMAN PRESCRIPTION DRUG Rifampin Rifampin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120601 ANDA ANDA065502 AKORN, Inc. RIFAMPIN 600 mg/10mL Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 17478-190_a9c7e4e4-9728-42ee-a6d8-8b08cbba8975 17478-190 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine lidocaine and prilocaine CREAM TOPICAL 20121112 NDA AUTHORIZED GENERIC NDA019941 Akorn, Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 17478-200_1e9e91bc-17ef-4ceb-bc67-036dd5efc3f9 17478-200 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19910701 UNAPPROVED DRUG OTHER Akorn, Inc. PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 17478-205_2a26ef2c-c715-415c-9258-f6bc267eb55f 17478-205 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19910701 UNAPPROVED DRUG OTHER Akorn, Inc. PHENYLEPHRINE HYDROCHLORIDE 100 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 17478-207_48c2e2b9-4b7c-488a-a658-6a3097829e42 17478-207 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION/ DROPS OPHTHALMIC 20140210 ANDA ANDA203376 Akorn KETOROLAC TROMETHAMINE 4.5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 17478-208_dddd44c2-70a9-4a16-b1f9-e155232c64f0 17478-208 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA078399 Akorn Inc. KETOROLAC TROMETHAMINE 4 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 17478-209_1893c415-ce53-46b9-8914-723f9a55b2d1 17478-209 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA078434 Akorn Inc. KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 17478-215_9a6b73d9-1e23-40e7-b80e-9b12e3e2a886 17478-215 HUMAN PRESCRIPTION DRUG Atropine Atropine Sulfate SOLUTION/ DROPS OPHTHALMIC 20140718 NDA NDA206289 Akorn, Inc. ATROPINE SULFATE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 17478-216_70e961a5-5aab-4ce7-b564-b8c2a89da1d3 17478-216 HUMAN PRESCRIPTION DRUG Naphazoline Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19951219 ANDA ANDA083590 Akorn, Inc. NAPHAZOLINE HYDROCHLORIDE 1 mg/mL 17478-221_f1769ef3-01ed-41b8-8b30-5741c4caba39 17478-221 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SOLUTION/ DROPS OPHTHALMIC 20140911 ANDA ANDA040215 Akorn, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 17478-235_4c70afb3-2cc3-4405-9a6e-06d444ebc2cb 17478-235 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 19900930 ANDA ANDA065088 Akorn, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 10000 [USP'U]/g; mg/g; [USP'U]/g Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 17478-238_926a4b95-b197-400b-8e5d-e5e2ff4521cb 17478-238 HUMAN PRESCRIPTION DRUG AK-POLY-BAC Bacitracin Zinc and Polymyxin B Sulfate OINTMENT OPHTHALMIC 20060508 ANDA ANDA064028 Akorn, Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 17478-242_f1769ef3-01ed-41b8-8b30-5741c4caba39 17478-242 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SOLUTION/ DROPS OPHTHALMIC 20140911 ANDA ANDA040216 Akorn, Inc. SULFACETAMIDE SODIUM 300 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 17478-250_926997f2-7be9-4626-bdef-73a90f09194b 17478-250 HUMAN PRESCRIPTION DRUG AK-FLUOR fluorescein sodium INJECTION INTRAVENOUS 20081001 NDA NDA022186 Akorn FLUORESCEIN SODIUM 250 mg/mL Diagnostic Dye [EPC],Dyes [MoA] 17478-253_926997f2-7be9-4626-bdef-73a90f09194b 17478-253 HUMAN PRESCRIPTION DRUG AK-FLUOR fluorescein sodium INJECTION INTRAVENOUS 20081001 NDA NDA022186 Akorn FLUORESCEIN SODIUM 100 mg/mL Diagnostic Dye [EPC],Dyes [MoA] 17478-263_61f6f83c-a75f-4eb2-a4f1-e274bbbff738 17478-263 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20000316 ANDA ANDA040277 Akorn, Inc. PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] 17478-283_e855bb7e-6d8d-40c0-907f-58b4406ccdc6 17478-283 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 20061213 ANDA ANDA064163 Akorn, Inc. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 17478-284_45bf825e-2e72-4033-b599-c884005d0504 17478-284 HUMAN PRESCRIPTION DRUG Gentak Gentamicin Sulfate OINTMENT OPHTHALMIC 20060508 ANDA ANDA064093 Akorn, Inc. GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 17478-288_1ac0f4e3-589b-4db1-b8ab-58b7a14c04c5 17478-288 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20120326 ANDA ANDA074466 Akorn, Inc. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 17478-289_1ac0f4e3-589b-4db1-b8ab-58b7a14c04c5 17478-289 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20120326 ANDA ANDA074465 Akorn, Inc. TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 17478-290_b878b03f-20e2-4f63-bf8e-e91326fe2628 17478-290 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION/ DROPS OPHTHALMIC 19960131 ANDA ANDA064096 Akorn, Inc. TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 17478-291_4d3b71aa-a864-4184-8274-51fde81d6997 17478-291 HUMAN PRESCRIPTION DRUG Cromolyn Sodium Cromolyn Sodium SOLUTION/ DROPS OPHTHALMIC 19980429 ANDA ANDA074706 Akorn, Inc. CROMOLYN SODIUM 40 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] 17478-307_673a79b0-5743-4084-aa83-03af374ad4b0 17478-307 HUMAN PRESCRIPTION DRUG AzaSITE Azithromycin Monohydrate SOLUTION/ DROPS OPHTHALMIC 20140514 NDA NDA050810 Akorn, Inc. AZITHROMYCIN MONOHYDRATE 10 mg/mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 17478-324_8f04e697-312f-4d6f-bc72-5f35467e3998 17478-324 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid SOLUTION INTRAVENOUS 20140821 ANDA ANDA200918 Akorn, Inc. ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 17478-327_1f578c39-5da1-4cd6-9a50-0ef437151c45 17478-327 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140522 ANDA ANDA202548 Akorn ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 17478-340_4d4ea03d-1759-4aef-999c-3447fa2c68f5 17478-340 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION ORAL 20140529 ANDA ANDA201422 Akorn, Inc. TOBRAMYCIN 300 mg/5mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 17478-403_91f37154-901e-404f-9fb2-311bc4077fb5 17478-403 HUMAN PRESCRIPTION DRUG FUL-GLO Fluorescein Sodium STRIP OPHTHALMIC 20040601 UNAPPROVED DRUG OTHER Akorn, Inc. D&C YELLOW NO. 8 .6 mg/1 Diagnostic Dye [EPC],Dyes [MoA] 17478-404_77814317-75f7-4b58-87e7-0fb7508b9b07 17478-404 HUMAN PRESCRIPTION DRUG FUL-GLO Fluorescein Sodium STRIP OPHTHALMIC 20040601 UNAPPROVED DRUG OTHER Akorn, Inc. D&C YELLOW NO. 8 1 mg/1 Diagnostic Dye [EPC],Dyes [MoA] 17478-419_8b346dfd-230e-4988-acf0-b460910ac138 17478-419 HUMAN PRESCRIPTION DRUG Chlorothiazide Sodium Chlorothiazide Sodium INJECTION INTRAVENOUS 20120813 NDA AUTHORIZED GENERIC NDA011145 Akorn, Inc. CHLOROTHIAZIDE SODIUM 500 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 17478-420_518c0d94-2c2b-48ef-a13f-d019dfe82b04 17478-420 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20040901 ANDA ANDA075431 Akorn, Inc. LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 17478-501_1ce0c87e-303b-4d45-ac12-bcd440c53eec 17478-501 HUMAN PRESCRIPTION DRUG Methylergonovine Maleate methylergonovine maleate INJECTION INTRAVENOUS 20110302 ANDA ANDA040889 Akorn, Inc. METHYLERGONOVINE MALEATE .2 mg/mL Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 17478-503_8c1f5624-8da1-4aa6-b6a6-e94f8d410f8b 17478-503 HUMAN PRESCRIPTION DRUG Dehydrated Alcohol Alcohol INJECTION INTRASPINAL 19970201 UNAPPROVED DRUG OTHER Akorn, Inc. ALCOHOL .98 mL/mL 17478-504_508f682c-668e-4a65-b424-446136da03c8 17478-504 HUMAN PRESCRIPTION DRUG Methylene Blue Methylene Blue INJECTION INTRAVENOUS 20090401 UNAPPROVED DRUG OTHER Akorn, Inc. METHYLENE BLUE 10 mg/mL 17478-508_5eda2b95-18fc-4a7e-b9d8-52c8b83fad51 17478-508 HUMAN PRESCRIPTION DRUG INDIGO CARMINE Indigotindisulfonate Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090401 UNAPPROVED DRUG OTHER Akorn, Inc. INDIGOTINDISULFONATE SODIUM 8 mg/mL 17478-510_11695f58-c5a9-424d-954d-086275b40291 17478-510 HUMAN PRESCRIPTION DRUG Physostigmine Salicylate Physostigmine Salicylate INJECTION INTRAVENOUS 20100810 UNAPPROVED DRUG OTHER Akorn PHYSOSTIGMINE SALICYLATE 1 mg/mL 17478-514_3ee531b6-c3f6-452e-9818-a1892383731d 17478-514 HUMAN PRESCRIPTION DRUG Dorzolamide HCl and Timolol Maleate Dorzolamide Hydrochloride and Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20140922 ANDA ANDA203058 Akorn, Inc. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 17478-515_c6d186e1-72f1-44e3-ae53-a45df5bf8f59 17478-515 HUMAN PRESCRIPTION DRUG Ephedrine Sulfate Ephedrine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20090401 UNAPPROVED DRUG OTHER Akorn, Inc. EPHEDRINE SULFATE 50 mg/mL 17478-523_84113f67-b333-416d-b285-dd1c9632ef80 17478-523 HUMAN PRESCRIPTION DRUG Midazolam Midazolam Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20050506 ANDA ANDA075494 Akorn, Inc. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 17478-524_84113f67-b333-416d-b285-dd1c9632ef80 17478-524 HUMAN PRESCRIPTION DRUG Midazolam Midazolam Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20050506 ANDA ANDA075494 Akorn, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 17478-526_e8e27a51-37d9-41b5-b6a7-d42782e4bc28 17478-526 HUMAN PRESCRIPTION DRUG BAL DIMERCAPROL INJECTION INTRAMUSCULAR 20120501 NDA NDA005939 Akorn, Inc. DIMERCAPROL 100 mg/mL Metal Chelating Activity [MoA],Metal Chelator [EPC] 17478-531_8496ebbf-5ea5-46de-b4a5-74d334d77ba7 17478-531 HUMAN PRESCRIPTION DRUG Inapsine Droperidol INJECTION INTRAMUSCULAR; INTRAVENOUS 19960701 NDA NDA016796 Akorn, Inc. DROPERIDOL 2.5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 17478-533_b65191f2-d300-49c7-ae08-78da2cfcff71 17478-533 HUMAN PRESCRIPTION DRUG Myochrysine Gold Sodium Thiomalate INJECTION INTRAMUSCULAR 20100422 UNAPPROVED DRUG OTHER Akorn, Inc. GOLD SODIUM THIOMALATE 50 mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 17478-538_04f6a0c3-1a20-4fff-8fde-6e7ab4006035 17478-538 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate INJECTION INTRAMUSCULAR; INTRAVENOUS 20061017 ANDA ANDA040484 Akorn, Inc. ORPHENADRINE CITRATE 30 mg/mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 17478-540_7b53c3d0-9181-4566-a2f5-6f9fbefc09ac 17478-540 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride INJECTION PARENTERAL 20100515 ANDA ANDA078228 Akorn, Inc. HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 17478-542_41a4dff1-fd99-4e59-b676-53281070862b 17478-542 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20110315 ANDA ANDA078076 Akorn, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 17478-544_88748eb1-1825-46de-9940-7ff647dc86e6 17478-544 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20141002 ANDA ANDA090450 Akorn, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 17478-546_03be5cb5-03e7-4ae1-9857-36178e37fb36 17478-546 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride INJECTION INTRAVENOUS 20091001 ANDA ANDA079078 Akorn Inc. GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 17478-547_03be5cb5-03e7-4ae1-9857-36178e37fb36 17478-547 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride INJECTION INTRAVENOUS 20091001 ANDA ANDA079119 Akorn Inc. GRANISETRON HYDROCHLORIDE .1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 17478-604_b6b1dacb-551a-44b2-92e2-86ede1c46dd7 17478-604 HUMAN PRESCRIPTION DRUG COSOPT PF Dorzolamide Hydrochloride and Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20140514 NDA NDA202667 Akorn, Inc. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 17478-605_8a0155ee-4593-42aa-88ea-2971a3c14e20 17478-605 HUMAN PRESCRIPTION DRUG COSOPT Dorzolamide Hydrochloride and Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20140430 NDA NDA020869 Akorn DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 17478-609_230c91fe-b5e0-46ac-bd10-a1944a58de2d 17478-609 HUMAN PRESCRIPTION DRUG ZIOPTAN tafluprost SOLUTION/ DROPS OPHTHALMIC 20141126 NDA NDA202514 Akorn, Inc. TAFLUPROST .0045 mg/.3mL Prostaglandin Analog [EPC],Prostaglandin Receptor Agonists [MoA],Increased Prostaglandin Activity [PE],Prostaglandins [Chemical/Ingredient] 17478-620_017f4341-eef9-4123-a184-906a22f61b7c 17478-620 HUMAN OTC DRUG Eyewash Water SOLUTION OPHTHALMIC 20140601 NDA NDA022305 Akorn, Inc. WATER 929 g/946mL 17478-622_d25c3c66-3424-4404-a969-de7c094b4e0a 17478-622 HUMAN OTC DRUG Sodium Chloride Sodium Chloride OINTMENT OPHTHALMIC 20060508 OTC MONOGRAPH FINAL part349 Akorn, Inc. SODIUM CHLORIDE 50 mg/g 17478-623_f4ab05eb-c2f7-4505-975c-8b2d554cfd3a 17478-623 HUMAN OTC DRUG Sodium Chloride Sodium Chloride SOLUTION/ DROPS OPHTHALMIC 19980401 OTC MONOGRAPH FINAL part349 Akorn, Inc. SODIUM CHLORIDE 50 mg/mL 17478-625_683835ab-0069-4b86-808f-674b2775e797 17478-625 HUMAN PRESCRIPTION DRUG LATANOPROST LATANOPROST SOLUTION/ DROPS OPHTHALMIC 20120701 ANDA ANDA090887 Akorn, Inc. LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 17478-640_b63db481-5b90-4817-b2f9-940ba2473d0b 17478-640 HUMAN PRESCRIPTION DRUG FLURESS Fluorescein Sodium and Benoxinate Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19950201 UNAPPROVED DRUG OTHER Akorn, Inc. BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM 4; 2.5 mg/mL; mg/mL Diagnostic Dye [EPC],Dyes [MoA] 17478-701_91661ee9-04fe-409e-9c4a-858625c53eed 17478-701 HUMAN PRESCRIPTION DRUG IC-Green indocyanine green KIT INTRAVENOUS 20070901 NDA NDA011525 Akorn, Inc. 17478-703_ad0796b0-1f91-46a5-a18d-4b315ee95fe0 17478-703 HUMAN PRESCRIPTION DRUG Trimethoprim sulfate and Polymyxin B sulfate Trimethoprim sulfate and Polymyxin B sulfate SOLUTION OPHTHALMIC 19981217 ANDA ANDA065006 Akorn, Inc. POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 17478-704_af120012-4fed-4126-b227-fb50fba7bffa 17478-704 HUMAN PRESCRIPTION DRUG Paremyd Hydroxyamphetamine hydrobromide, tropicamide SOLUTION OPHTHALMIC 19920130 NDA NDA019261 Akorn, Inc. HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE 10; 2.5 mg/mL; mg/mL Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 17478-705_ca9d088a-58a5-448f-8b53-23e356734dfa 17478-705 HUMAN PRESCRIPTION DRUG Betaxolol Betaxolol Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20030401 ANDA ANDA075386 Akorn, Inc. BETAXOLOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 17478-711_a226e972-e8cd-468e-b39c-9ea734d5ef3a 17478-711 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride JELLY TOPICAL 20030801 ANDA ANDA040433 Akorn, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 17478-713_8ec38b43-795a-45ba-bbd3-8ebd6e1fcdf2 17478-713 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20080701 ANDA ANDA076407 Akorn, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 17478-714_87180bd3-1c89-4583-aae3-956fac82c907 17478-714 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20090724 ANDA ANDA076555 Akorn Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 17478-715_7f94cd83-a6f7-4511-8c1b-46c9b6e5bff7 17478-715 HUMAN PRESCRIPTION DRUG Brimonidine Brimonidine Tartrate SOLUTION/ DROPS OPHTHALMIC 20060907 ANDA ANDA076439 Akorn, Inc. BRIMONIDINE TARTRATE 2 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 17478-716_aa34a505-eb81-4a9b-9679-57b34d249bcd 17478-716 HUMAN PRESCRIPTION DRUG Apraclonidine Ophthalmic Apraclonidine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20090812 ANDA ANDA077764 Akorn Inc. APRACLONIDINE HYDROCHLORIDE 5 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 17478-717_494193f6-b78a-447f-9cf0-127e53748403 17478-717 HUMAN OTC DRUG Ketotifen Fumarate Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20071001 ANDA ANDA077958 Akorn, Inc. KETOTIFEN FUMARATE .35 mg/mL 17478-719_60ddae47-eb84-455b-af3f-6bf4e3d114bc 17478-719 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc, Hydrocortisone OINTMENT OPHTHALMIC 20120725 ANDA ANDA065213 Akorn, Inc. BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 10; 3.5; 10000 [USP'U]/g; mg/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 17478-741_3c2026bf-3ee4-4b95-bbb4-561d72251e5b 17478-741 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride CAPSULE ORAL 20120409 ANDA ANDA065478 Akorn, Inc. VANCOMYCIN HYDROCHLORIDE 125 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 17478-742_3c2026bf-3ee4-4b95-bbb4-561d72251e5b 17478-742 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride CAPSULE ORAL 20120409 ANDA ANDA065478 Akorn, Inc. VANCOMYCIN HYDROCHLORIDE 250 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 17478-761_25e42cf9-e32f-4bfc-862b-91c4238dca43 17478-761 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20140620 ANDA ANDA079217 Akorn, Inc. DRONABINOL 2.5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 17478-762_25e42cf9-e32f-4bfc-862b-91c4238dca43 17478-762 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20140620 ANDA ANDA079217 Akorn, Inc. DRONABINOL 5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 17478-763_25e42cf9-e32f-4bfc-862b-91c4238dca43 17478-763 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20140620 ANDA ANDA079217 Akorn, Inc. DRONABINOL 10 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 17478-766_e07c4c23-d6ff-421b-9d10-c3cc5afe07d3 17478-766 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20121004 ANDA ANDA200456 Akorn, Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 17478-767_e07c4c23-d6ff-421b-9d10-c3cc5afe07d3 17478-767 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20121004 ANDA ANDA200456 Akorn, Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 17478-792_a3f440eb-7cb2-4c2d-8661-89a0905cbb38 17478-792 HUMAN PRESCRIPTION DRUG Akten Lidocaine Hydrochloride GEL OPHTHALMIC 20081008 NDA NDA022221 Akorn, Inc. LIDOCAINE HYDROCHLORIDE ANHYDROUS 35 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 17478-808_59b02f43-ad26-4c56-8a14-9d0fa264ffe1 17478-808 HUMAN PRESCRIPTION DRUG INDIGO CARMINE Indigotindisulfonate Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130322 UNAPPROVED DRUG OTHER Akorn, Inc. INDIGOTINDISULFONATE SODIUM 8 mg/mL 17478-811_867285c1-a591-4751-bff9-59aab9e7b820 17478-811 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride JELLY TOPICAL 20030801 ANDA ANDA040433 Akorn, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 17478-817_876e7fef-525f-4ae6-add4-8ca1fd7e32be 17478-817 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION INTRAVENOUS 20131112 ANDA ANDA075086 Akorn, Inc. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 17478-823_59655d2f-7cb0-4a52-beb2-848280632405 17478-823 HUMAN PRESCRIPTION DRUG Ephedrine Sulfate Ephedrine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20120311 UNAPPROVED DRUG OTHER Akorn, Inc. EPHEDRINE SULFATE 50 mg/mL 17478-824_be7e90d7-f974-4ba9-b5e8-2d21fa1fd98e 17478-824 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 20130311 ANDA ANDA064030 Akorn, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 17478-825_222f2e92-432e-480e-91a7-c033e311e77f 17478-825 HUMAN PRESCRIPTION DRUG Dehydrated Alcohol Alcohol INJECTION INTRASPINAL 20130308 UNAPPROVED DRUG OTHER Akorn, Inc. ALCOHOL .98 mL/mL 17478-826_88f7a153-56d8-4934-8ff7-d4a64f19e5c3 17478-826 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 20130311 ANDA ANDA064163 Akorn, Inc. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 17478-827_3789cbb4-fbab-4985-9fcd-868efe1407b2 17478-827 HUMAN PRESCRIPTION DRUG Gentak Gentamicin Sulfate OINTMENT OPHTHALMIC 20130311 ANDA ANDA064093 Akorn, Inc. GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 17478-831_d8aebdd3-0586-4464-a515-abac8e4d96e3 17478-831 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol INJECTION INTRAVENOUS 20130322 ANDA ANDA078066 Akorn, Inc. CALCITRIOL 1 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 17478-834_1319c78d-4970-4c15-83a9-0e28d4856882 17478-834 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20130221 ANDA ANDA040730 Akorn, Inc. HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 17478-837_a0073823-56c0-4815-bce8-19794558ad2f 17478-837 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION INTRAVENOUS 20130322 ANDA ANDA075086 Akorn, Inc. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 17478-840_11e9bd9a-8a7d-460a-88e0-4243b32e6c91 17478-840 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride JELLY TOPICAL 20130801 ANDA ANDA040433 Akorn, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 17478-841_0c2bc497-3558-47bc-9e18-55e51143be66 17478-841 HUMAN PRESCRIPTION DRUG Alfentanil Alfentanil Hydrochloride INJECTION INTRAVENOUS 20130719 NDA NDA019353 Akorn, Inc. ALFENTANIL HYDROCHLORIDE 500 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 17478-892_020c593a-3f3e-4689-a8e7-7ed7d23532d0 17478-892 HUMAN PRESCRIPTION DRUG Diclofenac Diclofenac Sodium SOLUTION/ DROPS OPHTHALMIC 20080501 ANDA ANDA077845 Akorn, Inc. DICLOFENAC SODIUM 1 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 17478-920_b510a7ea-3e31-4c8a-807c-0939e9e78732 17478-920 HUMAN PRESCRIPTION DRUG BALANCED SALT Calcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, Sodium Chloride, Sodium Citrate SOLUTION OPHTHALMIC 20060927 ANDA ANDA075503 Akorn, Inc. CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE .48; .3; .75; 3.9; 6.4; 1.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 17478-931_262e9104-1a18-421c-935f-fc206758d540 17478-931 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol INJECTION INTRAVENOUS 20111014 ANDA ANDA078066 Akorn, Inc. CALCITRIOL 1 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 17478-932_262e9104-1a18-421c-935f-fc206758d540 17478-932 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol INJECTION INTRAVENOUS 20111014 ANDA ANDA078066 Akorn, Inc. CALCITRIOL 2 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 17478-933_452dcbc2-05fd-4ede-bb1b-be661eb85b31 17478-933 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate INJECTION SUBCUTANEOUS 20100201 ANDA ANDA078151 Akorn TERBUTALINE SULFATE 1 mg/mL 17478-934_37c43498-42dc-4cea-bcfc-d5a3d5a5f004 17478-934 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20090501 ANDA ANDA040730 Akorn, Inc. HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 17478-937_ea01bc05-ac1c-4943-b463-f3c01443e33e 17478-937 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION INTRAVENOUS 20061221 ANDA ANDA075086 Akorn, Inc. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 17518-001_d3b72eb4-8b9b-4cbb-b2c4-1002840f3095 17518-001 HUMAN OTC DRUG Hand Sanitizer Ultrathon Ethyl Alcohol GEL TOPICAL 20120409 OTC MONOGRAPH FINAL part333A 3M Health Care ALCOHOL 62 g/100mL 17518-002_c4d4dee3-d62c-4bd0-9aaf-57f0d8ff856b 17518-002 HUMAN OTC DRUG SPF 50 Broad Spectrum Ultrathon Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120409 OTC MONOGRAPH FINAL part352 3M Health Care AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 17518-003_2efff4ff-eb1d-4bc0-86d2-673ed3dc5f80 17518-003 HUMAN OTC DRUG Broad Spectrum SPF 30 Ultrathon Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LIQUID TOPICAL 20120425 OTC MONOGRAPH FINAL part352 3M Health Care AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 17518-004_a551fb6c-74b6-4e69-b1e1-133aa5dc9c0a 17518-004 HUMAN OTC DRUG SPF 50 Broad Spectrum Ultrathon Homosalate, Octinoxate, Octisalate, Octocrylene, Zinc Oxide STICK TOPICAL 20120409 OTC MONOGRAPH FINAL part352 3M Health Care HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 6; 7.5; 5; 10; 8 g/100g; g/100g; g/100g; g/100g; g/100g 17518-011_53d8dd08-2533-4c00-aa35-e86d8b195d1e 17518-011 HUMAN OTC DRUG 3M DuraPrep Surgical Iodine povacrylex and Isopropyl alcohol SOLUTION TOPICAL 20060929 NDA NDA021586 3M Health Care IODINE POVACRYLEX; ISOPROPYL ALCOHOL 6.02; 636.4 mg/mL; mg/mL 17518-011_794a9f1e-d49a-4d3b-b8e9-8fa3c5a3d491 17518-011 HUMAN OTC DRUG 3M DuraPrep Surgical Iodine povacrylex and Isopropyl alcohol SOLUTION TOPICAL 20060929 NDA NDA021586 3M Health Care IODINE POVACRYLEX; ISOPROPYL ALCOHOL 6.02; 636.4 mg/mL; mg/mL 17518-026_4b51fa72-bec9-4063-98f2-da86c908eeb9 17518-026 HUMAN OTC DRUG 3M Cavilon Durable Barrier Dimethicone CREAM TOPICAL 19960719 OTC MONOGRAPH FINAL part347 3M Health Care DIMETHICONE 13000 mg/L 17518-028_a6ede7b3-8dc5-4912-be69-c5d69a3759a8 17518-028 HUMAN OTC DRUG 3M Cavilon Durable Barrier Fragrance Free Dimethicone CREAM TOPICAL 20110331 OTC MONOGRAPH FINAL part347 3M Health Care DIMETHICONE 13000 mg/L 17518-050_56177f7e-7f7f-44e7-bd49-bd632b7564a6 17518-050 HUMAN OTC DRUG 3M Avagard D Alcohol LOTION TOPICAL 19991001 OTC MONOGRAPH NOT FINAL part333E 3M Health Care ALCOHOL 530.7 mg/mL 17518-051_ebaaa974-013f-49c9-9ab7-8f2bacab8805 17518-051 HUMAN OTC DRUG 3M Avagard Chlorhexidine Gluconate and Alcohol LOTION TOPICAL 20010614 NDA NDA021074 3M Health Care ALCOHOL; CHLORHEXIDINE GLUCONATE 506.3; 8.3 mg/mL; mg/mL 17518-053_209fa03b-397c-4055-8d1e-8b2fe73ef0a8 17518-053 HUMAN OTC DRUG 3M Avagard Foam Alcohol LIQUID TOPICAL 20070301 OTC MONOGRAPH NOT FINAL part333E 3M Health Care ALCOHOL 496 mg/mL 17518-054_993cbe8c-adc5-41be-bfec-e5cdd44319ca 17518-054 HUMAN OTC DRUG 3M Nexcare Cold Sore Treatment 3M Nexcare Cold Sore Treatment OINTMENT TOPICAL 20080220 OTC MONOGRAPH NOT FINAL part348 3M Company ALLANTOIN; BENZOCAINE 10; 50 mg/g; mg/g 17518-055_72d24431-c526-47ff-82da-2a558afdbb51 17518-055 HUMAN OTC DRUG 3M Avagard Foaming Instant Hand Antiseptic Alcohol LIQUID TOPICAL 20110527 OTC MONOGRAPH NOT FINAL part333E 3M Health Care ALCOHOL 548 mg/mL 17518-056_fd965c19-206a-4d9a-806b-4c413fa691ed 17518-056 HUMAN OTC DRUG 3M Avagard Instant Hand Antiseptic with Moisturizers Alcohol GEL TOPICAL 20130923 OTC MONOGRAPH NOT FINAL part333E 3M Health Care ALCOHOL 577.7 mg/mL 17518-060_ddd2db12-e338-45c4-ad62-bb89e5f1a5ad 17518-060 HUMAN OTC DRUG 3M Skin and Nasal Antiseptic Povidone-Iodine SOLUTION TOPICAL 20090701 OTC MONOGRAPH NOT FINAL part333E 3M Health Care POVIDONE-IODINE 5 mg/mL 17518-857_5db17e34-f83e-47d1-b04a-2668d105f3b8 17518-857 HUMAN OTC DRUG 3M Cavilon Antifungal miconazole nitrate CREAM TOPICAL 20101130 OTC MONOGRAPH FINAL part333C 3M Health Care MICONAZOLE NITRATE 2 g/1000g 17575-001_f2660a2b-0695-40f4-bbdf-f56cc001fa56 17575-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS AGL Inhalation Therapy Co. OXYGEN 990 mL/L 17575-004_1606ff48-5c9c-48c6-a135-9b2da806ea39 17575-004 HUMAN OTC DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS AGL Inhalation Therapy Co. CARBON DIOXIDE 990 mL/L 17575-005_2c4b6c72-2417-4683-b97c-05d8a7b7e4a0 17575-005 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS AGL Inhalation Therapy Co. HELIUM 990 mL/L 17575-006_27d5c055-cc00-4d76-a3a8-2952e8c793e9 17575-006 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS AGL Inhalation Therapy Co. NITROGEN 990 mL/L 17575-007_39b5852e-684e-404b-9581-bb59080012a3 17575-007 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS AGL Inhalation Therapy Co. AIR 1000 mL/L 17575-011_428027c8-6251-4a69-8ae7-b81502f3ac65 17575-011 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitroux Oxide GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS AGL Inhalation Therapy Co. NITROUS OXIDE 990 mL/L 17575-018_c8eafdb1-a31d-4cb4-b5fb-e28c8384de01 17575-018 HUMAN PRESCRIPTION DRUG Oxygen Helium Mixture 30/70 Oxygen Helium Mixture 30/70 GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS AGL Inhalation Therapy Co. HELIUM; OXYGEN 700; 300 mL/L; mL/L 17575-020_caf1230e-2ea8-4b98-9aa6-8af50cf2d791 17575-020 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mixture 5/95 Carbon Dioxide Oxygen Mixture 5/95 GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS AGL Inhalation Therapy Co. CARBON DIOXIDE; OXYGEN 50; 950 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 17575-190_5d36b115-5548-4049-9069-a83e7de66a2a 17575-190 HUMAN PRESCRIPTION DRUG Oxygen Helium Mixture 20/80 Oxygen Helium Mixture 20/80 GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS AGL Inhalation Therapy Co. HELIUM; OXYGEN 800; 200 mL/L; mL/L 17630-2000_3c007a4b-a0cb-4ab6-90e7-e564046c0475 17630-2000 HUMAN OTC DRUG New Hawaiian Tropic Sensitive Skin Lotion Sunscreen Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20091104 OTC MONOGRAPH NOT FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .03; .08; .06 g/g; g/g; g/g 17630-2001_d9c18759-a87f-481e-b69a-bbd7079d53f9 17630-2001 HUMAN OTC DRUG Banana Boat Baby Tear Free Sunscreen SPF 60 Homosalate and Octinoxate and Octisalate and Avobenzone and Octocrylene SPRAY TOPICAL 20091022 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .15; .075; .05; .024 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2002_9f025323-11fe-4dd4-9624-2c4a03815ab9 17630-2002 HUMAN OTC DRUG Banana Boat Kids Tear Free Sunscreen SPF 60 Homosalate and Octinoxate and Octisalate and Avobenzone and Octocrylene SPRAY TOPICAL 20091022 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .15; .075; .05; .024 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2003_0086e81b-d038-47fa-9d83-782fc54a7c06 17630-2003 HUMAN OTC DRUG Banana Boat UltraMist Baby Tear Free Continuous SPF 50 Avobenzone and Homosalate and Octinoxate and Octisalate and Octocrylene SPRAY TOPICAL 20091022 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .15; .075; .05; .024 g/g; g/g; g/g; g/g; g/g 17630-2004_7c7eff48-33f8-4279-a8d2-67988618b4b0 17630-2004 HUMAN OTC DRUG Banana Boat Kids Tear Free Continuous SPF 50 Avobenzone and Homosalate and Octinoxate and Octisalate and Octocrylene SPRAY TOPICAL 20091022 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .15; .075; .05; .024 g/g; g/g; g/g; g/g; g/g 17630-2005_9d1cd011-8b7f-4167-8a70-5a6cd917af82 17630-2005 HUMAN OTC DRUG Banana Boat Sport Performance SPF 15 Avobenzone and Homosalate and Octinoxate and Octisalate and Octocrylene and Oxybenzone SPRAY TOPICAL 20061202 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .05; .05; .025; .02 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2006_f665b5cc-971a-42d4-a47b-b91e69d5ab72 17630-2006 HUMAN OTC DRUG Banana Boat Baby Tear Free Lotion SPF 50 Homosalate and Octinoxate and Octisalate and Octocrylene and Avobenzone SPRAY TOPICAL 20090723 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .1; .075; .05; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2007_7902a1cb-8398-4127-8feb-3270158cabed 17630-2007 HUMAN OTC DRUG Banana Boat UltraMist Kids Tear Free Lotion SPF 50 Homosalate and Octinoxate and Octisalate and Octocrylene and Avobenzone SPRAY TOPICAL 20090723 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .1; .075; .05; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2008_615baf42-a82b-404d-a778-6099a96f4172 17630-2008 HUMAN OTC DRUG Banana Boat UltraMist Kids SPF 50 Factor de Proteccion Solar 50 Homosalate and Octinoxate and Octisalate and Octocrylene and Avobenzone SPRAY TOPICAL 20090723 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .1; .075; .05; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2009_1f44e8e0-2175-45c3-9bd3-61aac7fa7f58 17630-2009 HUMAN OTC DRUG Banana Boat Kids Sin Lagrimas Pump SPF 50 Homosalate and Octinoxate and Octisalate and Octocrylene and Avobenzone SPRAY TOPICAL 20090723 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .1; .075; .05; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2010_a602e76c-9dbe-491a-abe9-4178d1257ea8 17630-2010 HUMAN OTC DRUG Banana Boat Baby Sin Lagrimas SPF 50 Pump Homosalate and Octinoxate and Octisalate and Octocrylene and Avobenzone SPRAY TOPICAL 20090723 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .1; .075; .05; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2011_00b22981-e6f4-43d7-a37e-a7d8ccf73a9b 17630-2011 HUMAN OTC DRUG Banana Boat Kids UltraMist Tear Free SPF 30 Avobenzone and Homosalate and Octisalate and Octocrylene SPRAY TOPICAL 20080618 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .03; .15; .05; .025 g/g; g/g; g/g; g/g 17630-2012_c6c46da9-5c2d-4af5-a183-4c3627b93e5c 17630-2012 HUMAN OTC DRUG Banana Boat Protective Dry SPF 10 Homosalate and Octisalate and Octocrylene and Avobenzone OIL TOPICAL 20090701 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .015; .06; .06; .025 mL/mL; mL/mL; mL/mL; mL/mL 17630-2013_9bdf3d53-69c7-42f5-b5e8-21cbcdc40eee 17630-2013 HUMAN OTC DRUG Hawaiian Tropic Tanning Dry SPF 6 Avobenzone and Octocrylene and Oxybenzone OIL TOPICAL 20090520 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .005; .035; .015 mL/mL; mL/mL; mL/mL 17630-2014_635e6e02-0003-42ef-882f-01df2ec0f540 17630-2014 HUMAN OTC DRUG Banana Boat Sport Performance SPF 85 Avobenzone and Homosalate and Octocrylene and Oxybenzone SPRAY TOPICAL 20090601 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE .03; .15; .1; .06 mL/mL; mL/mL; mL/mL; mL/mL 17630-2015_901b758c-9233-4d40-ac15-64487d1ceaca 17630-2015 HUMAN OTC DRUG Banana Boat Ultra Defense SPF 85 Avobenzone and Homosalate and Octocrylene and Oxybenzone SPRAY TOPICAL 20090601 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE .03; .15; .1; .06 mL/mL; mL/mL; mL/mL; mL/mL 17630-2016_ed38ed68-00e7-4b46-8f04-893bb4e9f4a9 17630-2016 HUMAN OTC DRUG Banana Boat Kids Protect and Play SPF 85 Avobenzone and Homosalate and Octocrylene and Oxybenzone SPRAY TOPICAL 20090601 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE .03; .15; .1; .06 mL/mL; mL/mL; mL/mL; mL/mL 17630-2017_d2e595d9-629c-4d9d-add3-e9c0d237b8ae 17630-2017 HUMAN OTC DRUG Banana Boat Protective Dry SPF 15 Avobenzone and Octocrylene and Oxybenzone OIL TOPICAL 20080717 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .03; .05; .03 mL/mL; mL/mL; mL/mL 17630-2018_2c23f218-5b62-4fee-a22a-b3f043c17ec1 17630-2018 HUMAN OTC DRUG Banana Boat Deep Tanning Dry SPF 8 Avobenzone and Octocrylene and Oxybenzone OIL TOPICAL 20080717 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .01; .03; .03 mL/mL; mL/mL; mL/mL 17630-2019_8765dc76-e236-49e9-a99c-de6d2da684b7 17630-2019 HUMAN OTC DRUG Banana Boat Deep Tanning Dry SPF 4 Avobenzone and Octocrylene and Oxybenzone OIL TOPICAL 20090916 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .005; .01; .005 mL/mL; mL/mL; mL/mL 17630-2020_6704904c-0a25-438d-bebe-f1f10ad01672 17630-2020 HUMAN OTC DRUG Banana Boat Sport Body and Scalp SPF 30 Homosalate and Octinoxate and Octisalate and Octocrylene and Oxybenzone and Avobenzone LOTION TOPICAL 20090609 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .0878; .05; .05; .025; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2021_f497ea15-b04b-4dab-b492-4dcf2f28bfc2 17630-2021 HUMAN OTC DRUG Banana Boat Sport SPF 30 Homosalate and Octinoxate and Octisalate and Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20090609 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .0878; .05; .05; .025; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2022_fa29e200-6cd5-459e-858d-c04045d0ab04 17630-2022 HUMAN OTC DRUG Banana Boat Ultra Defence SPF 30 for UK Homosalate and Octinoxate and Octisalate and Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20090609 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .0878; .05; .05; .025; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2023_be23fe01-6d34-422a-b7be-33de1c8e4221 17630-2023 HUMAN OTC DRUG Banana Boat Ultra Defense SPF 30 for LATAM Homosalate and Octinoxate and Octisalate and Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20090609 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .0878; .05; .05; .025; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2024_5a121d3c-63ea-4574-a5b5-a7eee3eb6a26 17630-2024 HUMAN OTC DRUG Banana Boat Ultramist Sport Performance SPF 50 Octocrylene and Avobenzone and Octisalate and Oxybenzone and Octinoxate and Homosalate SPRAY TOPICAL 20090209 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .0878; .075; .05; .025; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2025_ed658d67-77fd-4101-ae80-b31a4cf6b4d8 17630-2025 HUMAN OTC DRUG Banana Boat Aceite Bronceador Seco Tanning Dry SPF 6 Homosalate and Octisalate and Octocrylene and Avobenzone OIL TOPICAL 20090403 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .01; .04; .04; .025 mL/mL; mL/mL; mL/mL; mL/mL 17630-2026_9fdfa6f7-504a-4b57-8db1-e5d7c0667d53 17630-2026 HUMAN OTC DRUG Banana Boat Protective Dry SPF 6 Octocrylene and Oxybenzone and Avobenzone OIL TOPICAL 20090522 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .01; .03; .03 mL/mL; mL/mL; mL/mL 17630-2027_2142a0e1-ed1a-449e-a352-9f950fe4e792 17630-2027 HUMAN OTC DRUG Banana Boat Sport Performance SPF 30 Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20090909 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .01; .077; .03 mL/mL; mL/mL; mL/mL 17630-2028_f7696695-e133-4cfe-bc72-4d800139a99f 17630-2028 HUMAN OTC DRUG Banana Boat Quik Dri Sport Body and Scalp SPF 30 Avobenzone and Octocrylene and Oxybenzone LOTION TOPICAL 20090909 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .01; .077; .03 mL/mL; mL/mL; mL/mL 17630-2029_a077d77a-717c-475e-b812-2ee0fa43be25 17630-2029 HUMAN OTC DRUG Banana Boat Ultra Defense Sheer Protect SPF 30 Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20090909 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .01; .077; .03 mL/mL; mL/mL; mL/mL 17630-2030_07b667aa-e5ed-4964-ba8c-ee3ab41f05a5 17630-2030 HUMAN OTC DRUG Banana Boat Sport SPF 60 Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20090915 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .03; .1; .05 mL/mL; mg/mL; mL/mL 17630-2031_dd4a145a-af97-41bf-934e-0a536d79045e 17630-2031 HUMAN OTC DRUG Banana Boat Ultra Defense SPF 60 Canada Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20090915 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .03; .1; .05 mL/mL; mL/mL; mL/mL 17630-2032_329a8aca-13b0-4990-89bd-48e69e60ffba 17630-2032 HUMAN OTC DRUG Banana Boat Sport SPF 50 Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20090915 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .03; .1; .05 mL/mL; mL/mL; mL/mL 17630-2033_7edaa698-1afd-4f83-af48-2895d699c038 17630-2033 HUMAN OTC DRUG Banana Boat Ultra Defense Sheer Protect SPF 50 Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20090915 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .03; .1; .05 mL/mL; mL/mL; mL/mL 17630-2034_ac21efca-d5d1-4948-946f-91467f008ded 17630-2034 HUMAN OTC DRUG Banana Boat Kids Protect and Play SPF 50 Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20090915 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .03; .1; .05 mL/mL; mL/mL; mL/mL 17630-2035_a4e3211d-f25b-4e3e-b39d-028de892f165 17630-2035 HUMAN OTC DRUG Hawaiian Tropic Island Sport SPF 30 Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20091003 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .01; .077; .03 mL/mL; mL/mL; mL/mL 17630-2036_6f5f36d2-72b7-435d-9395-e0b961e19f24 17630-2036 HUMAN OTC DRUG Hawaiian Tropic Kids SPF 30 Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20091003 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .01; .077; .03 mL/mL; mL/mL; mL/mL 17630-2037_8d5b7e87-1323-4ea5-9a9b-434ba6c8f2f2 17630-2037 HUMAN OTC DRUG Hawaiian Tropic Sheer Touch SPF 30 Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20091003 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .01; .077; .03 mL/mL; mL/mL; mL/mL 17630-2038_e0df89ba-63cb-424c-9ead-a1188320a0ce 17630-2038 HUMAN OTC DRUG Hawaiian Tropic Island Sport SPF 30 for Canada Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20091003 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .01; .077; .03 mL/mL; mL/mL; mL/mL 17630-2039_eaf7f800-8986-43b1-9a61-ba9e2ed366ed 17630-2039 HUMAN OTC DRUG Hawaiian Tropic Carrot Protective Oil SPF 30 Octocrylene and Oxybenzone and Avobenzone OIL TOPICAL 20091215 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .02; .077; .03 mL/mL; mL/mL; mL/mL 17630-2040_d7b8f27e-e6c1-49e3-aaf5-89b61baa8a2e 17630-2040 HUMAN OTC DRUG Banana Boat Sport Performance SPF 30 Canada Homosalate and Octinoxate and Octisalate and Oxybenzone and Avobenzone and Octocrylene SPRAY TOPICAL 20100102 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .0878; .05; .05; .025; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2041_b862a610-f3db-4809-9a68-64e7cb0d2748 17630-2041 HUMAN OTC DRUG Banana Boat Ultra Defense SPF 30 Canada Homosalate and Octinoxate and Octisalate and Oxybenzone and Avobenzone and Octocrylene SPRAY TOPICAL 20100102 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .0878; .05; .05; .025; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2042_e7ede41e-8d88-4c4f-a3d4-bf313ba4f3d6 17630-2042 HUMAN OTC DRUG Banana Boat Sport Performance SPF 15 Canada Homosalate and Octinoxate and Octisalate and Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20090914 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .05; .05; .025; .02 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2043_b4aebf76-9b82-4a6b-9189-fcafdecbd758 17630-2043 HUMAN OTC DRUG Banana Boat Ultra defense SPF 50 Canada Homosalate and Octinoxate and Octisalate and Oxybenzone and Avobenzone and Octocrylene SPRAY TOPICAL 20090914 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .0878; .075; .05; .025; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2044_48c3ba2a-bd4b-4426-98b4-5622274eab56 17630-2044 HUMAN OTC DRUG Banana Boat Ultra Defense Sheer Protect FPS 50 LATAM Homosalate and Octinoxate and Octisalate and Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20100315 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .0878; .075; .05; .025; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17630-2045_289b4459-15ba-45f6-b571-51559b4b2d2e 17630-2045 HUMAN OTC DRUG Banana Boat Ultra Mist Kids FPS 60 LATAM Homosalate and Octinoxate and Octisalate and Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20100309 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .1; .075; .05; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 17714-009_655159bb-d283-4504-ad3f-562f8ba85782 17714-009 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 19880415 OTC MONOGRAPH FINAL part343 Advance Pharmaceutical Inc. ASPIRIN 81 mg/1 17714-010_8e476ecc-c829-4977-844b-c92d57dde993 17714-010 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20020109 OTC MONOGRAPH FINAL part343 Advance Pharmaceutical Inc. ASPIRIN 325 mg/1 17714-011_a4b80d52-4394-4c6a-af5d-fef3ea1ac72d 17714-011 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19900508 OTC MONOGRAPH FINAL part343 Advance Pharmaceutical Inc. ASPIRIN 325 mg/1 17714-012_1d2e4055-3526-4707-8663-85c32dfb272c 17714-012 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 19890205 OTC MONOGRAPH FINAL part343 Advance Pharmaceutical Inc. ACETAMINOPHEN 325 mg/1 17714-013_de70766a-69dc-4258-81fb-0ef82c02fc8a 17714-013 HUMAN OTC DRUG APAP Acetaminophen TABLET ORAL 19890205 OTC MONOGRAPH FINAL part343 Advance Pharmaceutical Inc. ACETAMINOPHEN 500 mg/1 17714-014_70309c76-934b-4891-80fd-1402b95cdfb4 17714-014 HUMAN OTC DRUG APAP Acetaminophen TABLET ORAL 19900114 OTC MONOGRAPH FINAL part343 Advance Pharmaceutical Inc. ACETAMINOPHEN 500 mg/1 17714-016_93a742c3-ea56-4984-a1d5-890583b181b3 17714-016 HUMAN OTC DRUG Anti Allergy Chlorpheniramine Maleate TABLET ORAL 20020109 OTC MONOGRAPH FINAL part341 Advance Pharmaceutical Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 17714-019_7bf77325-4a8a-4763-89a1-bd82f1838f8f 17714-019 HUMAN OTC DRUG GAS RELIEF Simethicone TABLET, CHEWABLE ORAL 19991104 OTC MONOGRAPH FINAL part332 Advance Pharmaceutical Inc. DIMETHICONE 80 mg/1 17714-020_1dee1215-55a5-430f-a50b-02fceb4535b6 17714-020 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 19890912 OTC MONOGRAPH FINAL part341 Advance Pharmaceutical Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 17714-021_47bb2ce7-b120-4b3f-a3ec-c575f0d5cfd3 17714-021 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 19891005 OTC MONOGRAPH FINAL part341 Advance Pharmaceutical Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 17714-025_17ad8654-7d93-469a-b996-1b945e790a60 17714-025 HUMAN OTC DRUG ANTACID Calcium Carbonate TABLET ORAL 19900406 OTC MONOGRAPH FINAL part331 Advance Pharmaceutical Inc. CALCIUM CARBONATE 648 mg/1 17714-041_fd016912-6560-449a-bfbc-e5e522b7ceee 17714-041 HUMAN OTC DRUG ANTACID Calcium Carbonate TABLET, CHEWABLE ORAL 20071130 OTC MONOGRAPH FINAL part331 Advance Pharmaceutical Inc. CALCIUM CARBONATE 500 mg/1 17714-043_b43c92b6-7139-4efa-bd71-3c4cc35d3dd8 17714-043 HUMAN OTC DRUG ANTACID Calcium Carbonate TABLET, CHEWABLE ORAL 19960126 OTC MONOGRAPH FINAL part331 Advance Pharmaceutical Inc. CALCIUM CARBONATE 500 mg/1 17714-045_c247abd4-8a28-4147-b6c3-94966eaf8d28 17714-045 HUMAN OTC DRUG Pepto Relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20020109 OTC MONOGRAPH FINAL part335 Advance Pharmaceutical Inc. BISMUTH SUBSALICYLATE 262 mg/1 17714-121_184d7697-8fe5-45b1-942d-8caa6547c6ba 17714-121 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19990612 OTC MONOGRAPH FINAL part343 Advance Pharmaceutical Inc. ASPIRIN 81 mg/1 17714-133_079fcfcb-218c-4e95-bcc1-d01d9bc1e6f0 17714-133 HUMAN OTC DRUG ACETAMINOPHEN PM ACETAMINOPHEN PM TABLET ORAL 20020109 OTC MONOGRAPH FINAL part341 Advance Pharmaceutical Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 17714-135_de0b674c-0bd6-4037-bcd5-74de0aa5b3ad 17714-135 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride TABLET ORAL 20060926 OTC MONOGRAPH FINAL part341 Advance Pharmaceutical Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 17772-101_f5dc2902-f163-449c-ae2c-7feb37efdac5 17772-101 HUMAN PRESCRIPTION DRUG Trokendi XR topiramate CAPSULE, EXTENDED RELEASE ORAL 20130816 NDA NDA201635 Supernus Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 17772-102_f5dc2902-f163-449c-ae2c-7feb37efdac5 17772-102 HUMAN PRESCRIPTION DRUG Trokendi XR topiramate CAPSULE, EXTENDED RELEASE ORAL 20130816 NDA NDA201635 Supernus Pharmaceuticals, Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 17772-103_f5dc2902-f163-449c-ae2c-7feb37efdac5 17772-103 HUMAN PRESCRIPTION DRUG Trokendi XR topiramate CAPSULE, EXTENDED RELEASE ORAL 20130816 NDA NDA201635 Supernus Pharmaceuticals, Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 17772-104_f5dc2902-f163-449c-ae2c-7feb37efdac5 17772-104 HUMAN PRESCRIPTION DRUG Trokendi XR topiramate CAPSULE, EXTENDED RELEASE ORAL 20130816 NDA NDA201635 Supernus Pharmaceuticals, Inc. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 17772-121_320831e0-60d3-11e2-8fb0-0002a5d5c51b 17772-121 HUMAN PRESCRIPTION DRUG OXTELLAR XR OXCARBAZEPINE TABLET ORAL 20130117 NDA NDA202810 Supernus OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 17772-122_320831e0-60d3-11e2-8fb0-0002a5d5c51b 17772-122 HUMAN PRESCRIPTION DRUG OXTELLAR XR OXCARBAZEPINE TABLET ORAL 20130117 NDA NDA202810 Supernus OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 17772-123_320831e0-60d3-11e2-8fb0-0002a5d5c51b 17772-123 HUMAN PRESCRIPTION DRUG OXTELLAR XR OXCARBAZEPINE TABLET ORAL 20130117 NDA NDA202810 Supernus OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 17819-1066_161bfcfa-e32b-487b-944b-16f60b7de25c 17819-1066 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19870101 UNAPPROVED MEDICAL GAS AWESCO NITROGEN 99 L/100L 17856-0008_ce62f292-478c-46bc-9538-a3d7465263e4 17856-0008 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20120703 NDA NDA021282 Atlantic Biologicals Corps GUAIFENESIN 600 mg/1 17856-0021_42719fda-d898-4749-b561-f85a5e54cd06 17856-0021 HUMAN PRESCRIPTION DRUG Renagel Renagel TABLET ORAL 20080606 NDA NDA021179 Atlantic Biologicals Corps SEVELAMER HYDROCHLORIDE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 17856-0057_7a0fee6f-de5d-4bf9-8a32-9e61e79d084c 17856-0057 HUMAN PRESCRIPTION DRUG Digoxin Digoxin SOLUTION ORAL 20040826 NDA NDA021648 Atlantic Biologicals Corps DIGOXIN .05 mg/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 17856-0067_82c40b58-dc51-435a-9447-e3041bc921b2 17856-0067 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20020624 ANDA ANDA040420 Atlantic Biologicals Corps PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 17856-0079_f3b17ea9-5357-4b18-83a2-319b04f78ca7 17856-0079 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 19960426 ANDA ANDA040119 Atlantic Biologicals Corps ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 17856-0082_e0b2e824-c9ae-4949-a75e-c34c459be4b6 17856-0082 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir SUSPENSION ORAL 20050607 ANDA ANDA077026 Atlantic Biologicals Corps ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 17856-0088_f41a71be-60fe-4c50-baa0-f8986c6ee99b 17856-0088 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20080226 ANDA ANDA077728 Atlantic Biologicals Corps CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 17856-0108_a5f6f300-167e-d40a-1071-f035c247c651 17856-0108 HUMAN PRESCRIPTION DRUG RAMIPRIL RAMIPRIL CAPSULE ORAL 20080618 ANDA ANDA077900 Atlantic Biologicals Corps RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 17856-0194_84224201-655f-418c-ab0e-e39eaa7b5831 17856-0194 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Atlantic Biologicals Corps NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 17856-0205_8fe8cdc9-104d-4dc7-a2ad-49f6e5894843 17856-0205 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride SYRUP ORAL 20020705 ANDA ANDA076058 Atlantic Biologicals Corps MIDAZOLAM HYDROCHLORIDE 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 17856-0241_0ce8f429-8cd1-4e90-bd8d-7175e5ab5022 17856-0241 HUMAN PRESCRIPTION DRUG levetiracetam levetiracetam SOLUTION ORAL 20120228 ANDA ANDA090601 Atlantic Biologicals Corps LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 17856-0380_09287282-1b8e-4c4d-a32f-193630499b8e 17856-0380 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20110531 ANDA ANDA091384 Atlantic Biologicals Corps RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] 17856-0423_4420e7d0-bd62-4500-9d5f-b0e29ab20202 17856-0423 HUMAN PRESCRIPTION DRUG Donnatal phenobarbital elixir ELIXIR ORAL 20091101 UNAPPROVED DRUG OTHER Atlantic Biologicals Corps ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 17856-0443_66f70512-0231-48f7-b4ee-296aa63bd397 17856-0443 HUMAN OTC DRUG STOOL SOFTENER EXTRA STRENGTH DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Atlantic Biologicals Corps DOCUSATE SODIUM 250 mg/1 17856-0490_ab07193f-6c9b-4fc5-8a0b-49c62e3b6268 17856-0490 HUMAN PRESCRIPTION DRUG Hydrocodone Polistirex and Chlorpheniramine Polistirex Pennkinetic hydrocodone bitartrate and chlorpheniramine maleate SUSPENSION, EXTENDED RELEASE ORAL 19871231 NDA AUTHORIZED GENERIC NDA019111 Atlantic Biologicals Corps CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE 8; 10 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CIII 17856-0604_f9917f94-1268-42fb-ba0e-75e11c19ba8a 17856-0604 HUMAN PRESCRIPTION DRUG Dextromethorphan Hydrobromide and Promethazine Hydrochloride Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL 19850104 ANDA ANDA088864 Atlantic Biologicals Corps DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 17856-0608_0e49ffbd-9e5a-469b-ba93-379548af10b9 17856-0608 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SYRUP ORAL 19821115 ANDA ANDA087953 Atlantic Biologicals Corps PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 17856-0618_8f9655ba-3bea-4a51-9a5d-4dcd3c34f185 17856-0618 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride SOLUTION ORAL 19951117 ANDA ANDA074352 Atlantic Biologicals Corps LOPERAMIDE HYDROCHLORIDE 1 mg/5mL 17856-0644_a2be0daf-8d5e-469f-a61b-cfcee7a19c16 17856-0644 HUMAN PRESCRIPTION DRUG ELIXOPHYLLIN THEOPHYLLINE ANHYDROUS LIQUID ORAL 20091001 ANDA ANDA085186 Atlantic Biologicals Corps THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 17856-0664_9d0f743b-84a7-4258-93d6-4ab6b573e400 17856-0664 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SOLUTION ORAL 20100312 ANDA ANDA078312 Atlantic Biologicals Corps RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 17856-0668_53134984-468f-4913-982c-30f895aa6154 17856-0668 HUMAN PRESCRIPTION DRUG PRENATAL PLUS VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE TABLET, FILM COATED ORAL 20091202 UNAPPROVED DRUG OTHER Atlantic Biologicals Corps .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE 22; 920; 120; 200; 400; 2; 12; 27; 1; 20; 10; 3; 1.84; 3080; 25 mg/1; [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 17856-0685_1b851ea3-1cfb-4477-b72d-e878a3519e16 17856-0685 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20091027 ANDA ANDA090992 Atlantic Biologicals Corps LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 17856-0691_fc1901d0-7944-41d5-9f7d-aabe6785dabc 17856-0691 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron SOLUTION ORAL 20101217 ANDA ANDA091483 Atlantic Biologicals Corps ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 17856-0759_fa49330e-8ce4-4d79-b870-e22b7a0fc709 17856-0759 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20050525 ANDA ANDA076913 Atlantic Biologicals Corps PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 17856-0775_97c0bf7b-49ca-47d6-a034-0d8ddcc43354 17856-0775 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19950710 ANDA ANDA040014 Atlantic Biologicals Corps LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 17856-0788_88f9cba9-e8a2-4ea7-89ce-dbb906b7d175 17856-0788 HUMAN OTC DRUG MILK OF MAGNESIA ORIGINAL magnesium hydroxide LIQUID ORAL 20101208 OTC MONOGRAPH FINAL part334 Atlantic Biologicals Corps MAGNESIUM HYDROXIDE 1200 mg/15mL 17856-0792_ecfe5102-f404-416a-a0c1-a798f9446642 17856-0792 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid SOLUTION ORAL 19950113 ANDA ANDA074060 Atlantic Biologicals Corps VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 17856-0804_bac94880-a702-43e3-ba7e-0c62928a0c31 17856-0804 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Codeine Phosphate Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 19970826 ANDA ANDA040151 Atlantic Biologicals Corps CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 17856-0823_68dd81d9-4a49-4eec-94fb-5a8ddb38b079 17856-0823 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 19971229 ANDA ANDA074650 Atlantic Biologicals Corps SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 17856-0865_867f210f-d85c-4e78-b8a0-cf5d05416227 17856-0865 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090116 ANDA ANDA079120 Atlantic Biologicals Corps LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 17856-0907_23be6d9b-9f77-413c-aa1a-9e295b5844ca 17856-0907 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20010725 ANDA ANDA075671 Atlantic Biologicals Corps MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 17856-0949_bcb4eb8f-40da-47b5-9061-dbc973467acb 17856-0949 HUMAN PRESCRIPTION DRUG Megace ES megesterol acetate SUSPENSION ORAL 20050702 NDA NDA021778 Atlantic Biologicals Corps MEGESTROL ACETATE 125 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 17856-1000_e57f9a0b-fff5-437e-a875-7a105de8fd09 17856-1000 HUMAN OTC DRUG Senexon Sennosides A and B SYRUP ORAL 20130215 OTC MONOGRAPH NOT FINAL part334 Atlantic Biologicals Corps SENNOSIDES A AND B 8.8 mg/5mL 17856-1161_51e22cd5-db35-4414-9944-bfe20048a545 17856-1161 HUMAN PRESCRIPTION DRUG dicyclomine hydrochloride dicyclomine hydrochloride SOLUTION ORAL 20050623 ANDA ANDA040169 Atlantic Biologicals Corps DICYCLOMINE HYDROCHLORIDE 10 mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 17856-1206_c409a22d-9e77-4cf5-b8db-3d2f0d544fa1 17856-1206 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE PELLETS ORAL 20100813 NDA NDA020725 Atlantic Biologicals Corps PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 30000; 6000; 19000 [USP'U]/1; [USP'U]/1; [USP'U]/1 17856-1212_a5708817-22eb-45e9-a444-2b28f709201b 17856-1212 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE PELLETS ORAL 20100813 NDA NDA020725 Atlantic Biologicals Corps PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 60000; 12000; 38000 [USP'U]/1; [USP'U]/1; [USP'U]/1 17856-1224_c2989de9-dfa7-4470-8d03-cc40b849b3cc 17856-1224 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE PELLETS ORAL 20100813 NDA NDA020725 Atlantic Biologicals Corps PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 120000; 24000; 76000 [USP'U]/1; [USP'U]/1; [USP'U]/1 17856-1295_21db67fa-0781-4ddf-9f3a-a72bc0349543 17856-1295 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen SOLUTION ORAL 20031030 ANDA ANDA040520 Atlantic Biologicals Corps ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 17856-1313_97277c5f-34bd-4e1b-adee-422d78bb6f03 17856-1313 HUMAN OTC DRUG Bismatrol Bismuth Subsalicylate LIQUID ORAL 20080530 OTC MONOGRAPH FINAL part335 Atlantic Biologicals Corps BISMUTH SUBSALICYLATE 262 mg/15mL 17856-1378_f2fb27c9-8d75-4df6-ae4e-ab68d06125b1 17856-1378 HUMAN PRESCRIPTION DRUG Lactulose lactulose SOLUTION ORAL 20010726 ANDA ANDA075993 Atlantic Biologicals Corps LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 17856-1508_0bdcd8b2-ccbb-4148-ba72-d066dbf8f4ca 17856-1508 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital ELIXIR ORAL 19970101 UNAPPROVED DRUG OTHER Atlantic Biologicals Corps PHENOBARBITAL 20 mg/5mL CIV 17856-1585_482db043-19a2-486d-9dee-63a1fe4d49fc 17856-1585 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20060131 ANDA ANDA040650 Atlantic Biologicals Corps CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CV 17856-2001_2d021355-eb05-1843-39c5-1f2e5c02a82e 17856-2001 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20090801 ANDA ANDA077789 Atlantic Biologicals Corps CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] 17856-2002_2d021355-eb05-1843-39c5-1f2e5c02a82e 17856-2002 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20090801 ANDA ANDA077789 Atlantic Biologicals Corps CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] 17856-2002_2d38d4dc-d107-a4f8-0cc9-844e1391396d 17856-2002 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20090801 ANDA ANDA077789 Atlantic Biologicals Corps CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] 17856-3188_42034081-428c-1b3d-5062-ed0c8f970609 17856-3188 HUMAN PRESCRIPTION DRUG Diazepam Diazepam SOLUTION ORAL 19870403 ANDA ANDA070928 Atlantic Biologicals Corps DIAZEPAM 5 mg/5mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 17856-4069_ed7c1cbc-6b29-4419-9ca6-e4bf17a41313 17856-4069 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20040408 ANDA ANDA040521 Atlantic Biologicals Corps PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 17856-4091_25fc2f67-72d9-4170-ac0c-5519cfed31bc 17856-4091 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron SOLUTION ORAL 20101217 ANDA ANDA091483 Atlantic Biologicals Corps ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 17856-5180_12eab105-e605-4010-8be9-850f593ac064 17856-5180 HUMAN OTC DRUG Tussin Sugar Free Cough Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20090107 OTC MONOGRAPH FINAL part341 Atlantic Biologicals Corps DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 17856-5309_1906658a-aacd-49da-9522-8405a79c3d7d 17856-5309 HUMAN OTC DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 19990207 ANDA ANDA074937 Atlantic Biologicals Corps IBUPROFEN 100 mg/5mL 17856-5721_f944afac-f5ca-45a4-8953-155d0d229789 17856-5721 HUMAN OTC DRUG MINTOX aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part331 Atlantic Biologicals Corps ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 17856-5725_b67051cf-8977-4df0-8078-7c72000e57c6 17856-5725 HUMAN OTC DRUG MINTOX MAXIMUM STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part331 Atlantic Biologicals Corps ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 18018-501_2014a18e-f000-461c-9b94-70bd887eb7bf 18018-501 HUMAN OTC DRUG INSTANT HAND SANITIZER HAND SANITIZER KIT 20091101 OTC MONOGRAPH NOT FINAL part333 NINGBO CLEANER DAILY USED PRODUCTS CO. LTD. 18018-502_c2b5661f-05af-40c1-9635-42e649b20488 18018-502 HUMAN OTC DRUG ECOSAVE LAVENDER ANTIBACTERIAL HAND SOAP TRICLOSAN KIT 20091201 OTC MONOGRAPH NOT FINAL part333 NINGBO CLEANER DAILY USED PRODUCTS 18018-503_e5cd87f5-c81e-401c-8f57-d59e7253135a 18018-503 HUMAN OTC DRUG ECOSAVE GRAPEFRUIT AND LEMONGRASS SOAP ANTIBACTERIAL HAND SOAP TRICLOSAN KIT 20091201 OTC MONOGRAPH NOT FINAL part333 NINGBO CLEANER DAILY USED PRODUCTS 18018-504_3a378e5f-7de5-451e-985d-d4335803c756 18018-504 HUMAN OTC DRUG ECOSAVE JAPANESE CHERRY BLOSSOM SOAP ANTIBACTERIAL HAND SOAP TRICLOSAN KIT 20091201 OTC MONOGRAPH NOT FINAL part333 NINGBO CLEANER DAILY USED PRODUCTS 18027-030_2d02971d-7620-4383-af56-d44e0fe3620d 18027-030 HUMAN OTC DRUG PHARMACYS PRESCRIPTION ISOPROPYL ALCOHOL LIQUID TOPICAL 20141001 OTC MONOGRAPH FINAL part344 AMERICAN CONSUMER PRODUCTS LLC ISOPROPYL ALCOHOL 70 g/100g 18027-033_f40214c2-c0d8-4960-9ad0-4a94ee5d46c4 18027-033 HUMAN OTC DRUG PHARMACYS PRESCRIPTION HYDROGEN PEROXIDE LIQUID TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A AMERICAN CONSUMER PRODUCTS LLC HYDROGEN PEROXIDE 3 g/100g 18087-0001_1a2000c1-f84a-4a17-acc4-bff9ee9498a2 18087-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060106 UNAPPROVED MEDICAL GAS Anaconda Oxygen Service OXYGEN 99 L/100L 18472-175_65ee60ad-1906-4d96-9fe8-0203e0890d46 18472-175 HUMAN OTC DRUG Blue Ice Fermented Cod Liver Oil Calm Balm Camphor, Menthol, Eucalyptus Oil rub SALVE TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part348 ABS Corporation CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 1.3; 1.73; .37 g/49.5g; g/49.5g; g/49.5g 18482-018_178491bc-e88d-4dd1-a6b5-ef5ee48499ae 18482-018 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20050701 UNAPPROVED MEDICAL GAS Inland Welding Supply dba A-L Compressed Gases OXYGEN 995 mL/L 18482-128_51a87023-e1db-4204-8046-dbbc67ab01f9 18482-128 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitroux Oxide GAS RESPIRATORY (INHALATION) 20050701 UNAPPROVED MEDICAL GAS Inland Welding Supply dba A-L Compressed Gases NITROUS OXIDE 995 mL/L 18527-119_70fdf9c8-cfd9-45d3-ba29-af2b5f891eb0 18527-119 HUMAN PRESCRIPTION DRUG Cilostazol cilostazol TABLET ORAL 20140401 ANDA ANDA077722 BIOKEY INC. CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 18527-120_70fdf9c8-cfd9-45d3-ba29-af2b5f891eb0 18527-120 HUMAN PRESCRIPTION DRUG Cilostazol cilostazol TABLET ORAL 20140401 ANDA ANDA077831 BIOKEY INC. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 18657-102_ab097bd2-c43f-4488-aebf-cbadf26a890a 18657-102 HUMAN PRESCRIPTION DRUG HYLENEX Recombinant Hyaluronidase (Human Recombinant) INJECTION, SOLUTION SUBCUTANEOUS 20051202 NDA NDA021859 Halozyme, Inc. HYALURONIDASE (HUMAN RECOMBINANT) 150 [USP'U]/mL Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient] 18657-901_0cd5f30b-5608-4821-82c5-fed5be011677 18657-901 HUMAN PRESCRIPTION DRUG HYLENEX Recombinant Professional Sample Hyaluronidase (Human Recombinant) INJECTION, SOLUTION SUBCUTANEOUS 20051202 NDA NDA021859 Halozyme, Inc. HYALURONIDASE (HUMAN RECOMBINANT) 150 [USP'U]/mL Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient] 18754-061_f7fd4460-ffa4-402d-878d-016208e07d2d 18754-061 HUMAN PRESCRIPTION DRUG Methscopolamine Bromide methscopolamine bromide TABLET ORAL 20091022 NDA NDA008848 A. Aarons METHSCOPOLAMINE BROMIDE 2.5 mg/1 18754-062_f7fd4460-ffa4-402d-878d-016208e07d2d 18754-062 HUMAN PRESCRIPTION DRUG Methscopolamine Bromide methscopolamine bromide TABLET ORAL 20091022 NDA NDA008848 A. Aarons METHSCOPOLAMINE BROMIDE 5 mg/1 18860-101_506cd951-f50a-4d92-aa19-7e389b286d09 18860-101 HUMAN PRESCRIPTION DRUG FazaClo clozapine TABLET, ORALLY DISINTEGRATING ORAL 20070701 NDA NDA021590 Jazz Pharmaceuticals, Inc. CLOZAPINE 12.5 mg/1 Atypical Antipsychotic [EPC] 18860-102_506cd951-f50a-4d92-aa19-7e389b286d09 18860-102 HUMAN PRESCRIPTION DRUG FazaClo clozapine TABLET, ORALLY DISINTEGRATING ORAL 20080601 NDA NDA021590 Jazz Pharmaceuticals, Inc. CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] 18860-104_506cd951-f50a-4d92-aa19-7e389b286d09 18860-104 HUMAN PRESCRIPTION DRUG FazaClo clozapine TABLET, ORALLY DISINTEGRATING ORAL 20080601 NDA NDA021590 Jazz Pharmaceuticals, Inc. CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] 18860-105_506cd951-f50a-4d92-aa19-7e389b286d09 18860-105 HUMAN PRESCRIPTION DRUG FazaClo clozapine TABLET, ORALLY DISINTEGRATING ORAL 20100709 NDA NDA021590 Jazz Pharmaceuticals, Inc. CLOZAPINE 150 mg/1 Atypical Antipsychotic [EPC] 18860-106_506cd951-f50a-4d92-aa19-7e389b286d09 18860-106 HUMAN PRESCRIPTION DRUG FazaClo clozapine TABLET, ORALLY DISINTEGRATING ORAL 20100709 NDA NDA021590 Jazz Pharmaceuticals, Inc. CLOZAPINE 200 mg/1 Atypical Antipsychotic [EPC] 18860-121_cdf2b2f4-f6aa-4683-9232-68b8871295a0 18860-121 HUMAN PRESCRIPTION DRUG VERSACLOZ Clozapine SUSPENSION ORAL 20130215 NDA NDA203479 Jazz Pharmaceuticals, Inc. CLOZAPINE 50 mg/mL Atypical Antipsychotic [EPC] 18860-253_9ed49bc4-cb2c-409f-84b6-24d9c052df9f 18860-253 HUMAN PRESCRIPTION DRUG Gesticare DHA thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, choline bitartrate, doconexent, and icosapent KIT 20081001 UNAPPROVED DRUG OTHER Jazz Pharmaceuticals Commercial Corp. 18860-321_5dbea701-ba9c-4c05-b171-b35c6366e186 18860-321 HUMAN PRESCRIPTION DRUG Niravam alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20050401 NDA NDA021726 Jazz Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 18860-322_5dbea701-ba9c-4c05-b171-b35c6366e186 18860-322 HUMAN PRESCRIPTION DRUG Niravam alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20050401 NDA NDA021726 Jazz Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 18860-323_5dbea701-ba9c-4c05-b171-b35c6366e186 18860-323 HUMAN PRESCRIPTION DRUG Niravam alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20050401 NDA NDA021726 Jazz Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 18860-324_5dbea701-ba9c-4c05-b171-b35c6366e186 18860-324 HUMAN PRESCRIPTION DRUG Niravam alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20050401 NDA NDA021726 Jazz Pharmaceuticals, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 18860-341_f85451c8-229a-4ce8-948b-dfceb46265c9 18860-341 HUMAN PRESCRIPTION DRUG Parcopa Carbidopa and Levodopa TABLET, ORALLY DISINTEGRATING ORAL 20040901 ANDA ANDA076699 Jazz Pharmaceuticals, Inc. CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 18860-342_f85451c8-229a-4ce8-948b-dfceb46265c9 18860-342 HUMAN PRESCRIPTION DRUG Parcopa Carbidopa and Levodopa TABLET, ORALLY DISINTEGRATING ORAL 20040901 ANDA ANDA076699 Jazz Pharmaceuticals, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 18860-343_f85451c8-229a-4ce8-948b-dfceb46265c9 18860-343 HUMAN PRESCRIPTION DRUG Parcopa Carbidopa and Levodopa TABLET, ORALLY DISINTEGRATING ORAL 20040901 ANDA ANDA076699 Jazz Pharmaceuticals, Inc. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 18860-480_f3f8fca9-1981-471d-89f5-6b7fbb8f49d6 18860-480 HUMAN PRESCRIPTION DRUG Elestrin estradiol GEL TRANSDERMAL 20070601 NDA NDA021813 Jazz Pharmaceuticals Commercial Corp. ESTRADIOL .6 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 18860-490_a580f922-75d0-407e-a47f-2ad79b7f6900 18860-490 HUMAN PRESCRIPTION DRUG Elestrin estradiol GEL TRANSDERMAL 20070601 NDA NDA021813 Jazz Pharmaceuticals Commercial Corp. ESTRADIOL .6 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 18860-678_4b9be863-75cb-4a8c-ba76-4a59ce9d509f 18860-678 HUMAN PRESCRIPTION DRUG Gastrocrom cromolyn sodium SOLUTION, CONCENTRATE ORAL 19961101 NDA NDA020479 Jazz Pharmaceuticals Commercial Corp. CROMOLYN SODIUM 20 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] 18860-720_32e2149a-d3f7-4b58-9ea8-6bca739e1576 18860-720 HUMAN PRESCRIPTION DRUG Prialt ziconotide INJECTION, SOLUTION INTRATHECAL 20041228 NDA NDA021060 Jazz Pharmaceuticals, Inc. ZICONOTIDE ACETATE 100 ug/mL N-Calcium Channel Receptor Antagonists [MoA],N-type Calcium Channel Antagonist [EPC] 18860-722_32e2149a-d3f7-4b58-9ea8-6bca739e1576 18860-722 HUMAN PRESCRIPTION DRUG Prialt ziconotide INJECTION, SOLUTION INTRATHECAL 20041228 NDA NDA021060 Jazz Pharmaceuticals, Inc. ZICONOTIDE ACETATE 100 ug/mL N-Calcium Channel Receptor Antagonists [MoA],N-type Calcium Channel Antagonist [EPC] 18860-723_32e2149a-d3f7-4b58-9ea8-6bca739e1576 18860-723 HUMAN PRESCRIPTION DRUG Prialt ziconotide INJECTION, SOLUTION INTRATHECAL 20041228 NDA NDA021060 Jazz Pharmaceuticals, Inc. ZICONOTIDE ACETATE 25 ug/mL N-Calcium Channel Receptor Antagonists [MoA],N-type Calcium Channel Antagonist [EPC] 18860-752_fc886453-4cee-481a-98e7-29f46f65c3dd 18860-752 HUMAN PRESCRIPTION DRUG Natelle One doconexent,icosapent, tricalcium phosphate, ferrous fumarate, ascorbic acid, pyridoxine hydrochloride, alpha-tocopherol, and folic acid CAPSULE, GELATIN COATED ORAL 20100611 UNAPPROVED DRUG OTHER Jazz Pharmaceuticals Commercial Corp. .ALPHA.-TOCOPHEROL; ASCORBIC ACID; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; ICOSAPENT; PYRIDOXINE HYDROCHLORIDE; TRICALCIUM PHOSPHATE 30; 30; 250; 28; 1; .625; 25; 102 [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 18860-852_06b963be-0817-469e-ad3a-8096324fbe94 18860-852 HUMAN PRESCRIPTION DRUG Natelle One Natelle One CAPSULE, GELATIN COATED ORAL 20091109 UNAPPROVED DRUG OTHER na Azur Pharma, Inc. ALPHA-TOCOPHEROL, D-; ASCORBIC ACID; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; ICOSAPENT; PYRIDOXINE HYDROCHLORIDE; TRICALCIUM PHOSPHATE 30; 30; 250; 27; 1; .625; 25; 100 [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 19392-100_04f696ca-35d4-45b8-9ff1-105d35448bb7 19392-100 HUMAN OTC DRUG Hand Sanitizer alcohol LIQUID TOPICAL 20120611 OTC MONOGRAPH NOT FINAL part333E Humphreyline ALCOHOL 710 g/1000mL 19392-110_1c2db6f5-c0da-4b41-b417-9f421c8e93c9 19392-110 HUMAN OTC DRUG Hand Sanitizer Alcohol LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Humphreyline ALCOHOL 620 mL/1000mL 19392-120_cd1e5eb1-6117-47e7-bfae-6e956fd79ede 19392-120 HUMAN OTC DRUG Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140702 OTC MONOGRAPH NOT FINAL part333E Humphreyline BENZALKONIUM CHLORIDE 1.3 g/1000g 19392-130_04fcd1c8-c68a-2b16-e054-00144ff8d46c 19392-130 HUMAN OTC DRUG Hand Sanitizer alcohol LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E Humphreyline ALCOHOL 630 mL/1000mL 19392-210_f0eaffc2-6fb9-4934-8320-76cbcd938ef4 19392-210 HUMAN OTC DRUG Hand Sanitizer Alcohol LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Humphreyline ALCOHOL 620 mL/1000mL 19392-300_82e77db3-26a5-4ea6-a71e-64a319a9cebe 19392-300 HUMAN OTC DRUG sunscreen octinoxate, oxybenzone LIPSTICK TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 Humphreyline OCTINOXATE; OXYBENZONE 75; 40 mg/g; mg/g 19392-400_34817253-7264-43a8-bcaa-1258a75ba993 19392-400 HUMAN OTC DRUG sunscreen octinoxate, octisalate, octocrylene, oxybenzone LOTION TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 Humphreyline OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 65; 40; 70; 55 mg/g; mg/g; mg/g; mg/g 19392-500_b4b8dc11-a87f-46d2-924c-cb7cbeec608a 19392-500 HUMAN OTC DRUG hand sanitizer benzalkonium chloride LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part333E Humphreyline BENZALKONIUM CHLORIDE 1.3 g/1000g 19515-891_a3aec896-8445-46ae-bec1-06be266be0f6 19515-891 VACCINE Flulaval Quadrivalent 2014/2015 influenza virus vaccine SUSPENSION INTRAMUSCULAR 20140701 BLA BLA125163 ID Biomedical Corporation of Quebec INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (UV, FORMALDEHYDE INACTIVATED) 15; 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL 19515-893_cbd7d0a7-0918-462f-92d8-ebc374b56593 19515-893 VACCINE FLULAVAL 2014/2015 influenza virus vaccine SUSPENSION INTRAMUSCULAR 20140701 BLA BLA125163 ID Biomedical Corporation of Quebec INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (UV, FORMALDEHYDE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL 19515-894_a3aec896-8445-46ae-bec1-06be266be0f6 19515-894 VACCINE Flulaval Quadrivalent 2014/2015 influenza virus vaccine SUSPENSION INTRAMUSCULAR 20140701 BLA BLA125163 ID Biomedical Corporation of Quebec INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (UV, FORMALDEHYDE INACTIVATED) 15; 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL 20276-044_0df090c9-af5e-480c-b218-aea60e3fab64 20276-044 HUMAN OTC DRUG Lucky Daily Moisturizing dimethicone LOTION TOPICAL 20130131 OTC MONOGRAPH FINAL part347 Delta Brands Inc DIMETHICONE 1 g/100mL 20276-045_e148135d-5838-4188-9ed9-fbb1ba14106c 20276-045 HUMAN OTC DRUG Lucky Classic pyrithione zinc SHAMPOO TOPICAL 20120630 OTC MONOGRAPH FINAL part358H Delta Brands Inc PYRITHIONE ZINC .3 mL/100mL 20276-046_57148bde-b0d5-4920-bb13-ff02420f54c1 20276-046 HUMAN OTC DRUG Lucky 2in1 Classic pyrithione zinc SHAMPOO TOPICAL 20120630 OTC MONOGRAPH FINAL part358H Delta Brands Inc PYRITHIONE ZINC .3 mL/100mL 20276-047_2f971ee5-aa40-48df-9fc4-2b8c631907f8 20276-047 HUMAN OTC DRUG Lucky Dry Hair pyrithione zinc SHAMPOO TOPICAL 20120630 OTC MONOGRAPH FINAL part358H Delta Brands Inc PYRITHIONE ZINC .3 mL/100mL 20276-050_5f5955a9-8b67-43d7-9cf4-c872a4823640 20276-050 HUMAN OTC DRUG Lucky Antibacterial Deodorant Triclosan SOAP TOPICAL 20120621 OTC MONOGRAPH NOT FINAL part333A Delta Brands Inc. TRICLOSAN .2 g/100g 20276-051_4af5ad38-f151-4133-838c-b37dbc718d78 20276-051 HUMAN OTC DRUG Lucky Hand Sanitizer with Vitamin E Ethyl Alcohol LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333A Delta Brands Inc. ALCOHOL 70 mL/100mL 20276-052_250400c6-4e6b-4b7e-8dd5-3c1e9d2f6c45 20276-052 HUMAN OTC DRUG Lucky Hand Sanitizer with Aloe Vera Ethyl Alcohol LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333A Delta Brands Inc. ALCOHOL 70 mL/100mL 20276-053_3a8de065-9a88-43e9-969e-620cfccf2c97 20276-053 HUMAN OTC DRUG Lucky Hand Sanitizer Lavender Ethyl Alcohol LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333A Delta Brands Inc. ALCOHOL 70 mL/100mL 20276-054_73dc9831-bbe5-4fa5-adb2-fd8e258e2866 20276-054 HUMAN OTC DRUG Lucky Hand Sanitizer Citrus Zest Ethyl Alcohol LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333A Delta Brands Inc. ALCOHOL 70 mL/100mL 20276-100_964a2c4c-9d75-4ca5-8873-63b27161183b 20276-100 HUMAN OTC DRUG Chestrub Camphor Menthol Eucalyptus Oil OINTMENT TOPICAL 20091115 OTC MONOGRAPH NOT FINAL part348 Delta Brands Inc CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.7; 1; 1 g/100g; g/100g; g/100g 20276-150_10ce9854-5d39-4ad3-acb8-f7c9cf0407bc 20276-150 HUMAN OTC DRUG Lucky Instant Hand Sanitizer with Vitamin E and Moisturizers Ethyl Alcohol LIQUID TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc ALCOHOL 62 mL/100mL 20276-152_993a50e3-7948-4ef2-90e5-325fa125965c 20276-152 HUMAN OTC DRUG Lucky Instant Hand Sanitizer with Vitamin E Ethyl Alcohol LIQUID TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc ALCOHOL 62 mL/100mL 20276-154_b3c0a25b-784d-4d73-b2c9-3ba2c38d6125 20276-154 HUMAN OTC DRUG Lucky Instant Hand Sanitizer with Aloe Vera Ethyl Alcohol LIQUID TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc ALCOHOL 62 mL/100mL 20276-155_28834f79-d0be-4ca5-b632-82b7d825a63f 20276-155 HUMAN OTC DRUG Lucky Instant Hand Cleanser with Vitamin E Ethyl Alcohol LIQUID TOPICAL 20091208 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc ALCOHOL 62 mL/100mL 20276-156_1305a3e9-82ed-4c4e-aa98-2e905297ece6 20276-156 HUMAN OTC DRUG Lucky Instant Hand Sanitizer Citrus Zest Ethyl Alcohol LIQUID TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc ALCOHOL 62 mL/100mL 20276-157_6fc43064-aa85-4908-9b81-2b9d3b1d2dce 20276-157 HUMAN OTC DRUG Lucky Instant Hand Cleanser with Aloe Vera Ethyl Alcohol LIQUID TOPICAL 20091208 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc ALCOHOL 62 mL/100mL 20276-158_270ce0d4-8ede-41be-bbfd-5ee592dff801 20276-158 HUMAN OTC DRUG Lucky Antibacterial Hand Soap Supersoft Triclosan LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc TRICLOSAN .1 mL/100mL 20276-159_b33569e5-e611-42fc-843d-1ef69bede8ba 20276-159 HUMAN OTC DRUG Lucky Antibacterial Hand Soap Supersoft Triclosan LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc TRICLOSAN .1 mL/100mL 20276-160_f3773273-2ffc-473d-b274-883d225540f4 20276-160 HUMAN OTC DRUG Lucky Antibacterial Hand Soap Supersoft Triclosan LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc TRICLOSAN .1 mL/100mL 20276-161_2db0ca67-b0aa-4111-b3b7-ef4a8c33d93e 20276-161 HUMAN OTC DRUG Lucky Antibacterial Hand Soap Supersoft Triclosan LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc TRICLOSAN .1 mL/100mL 20276-162_6ee2584d-05b8-48f0-b48e-be26737cd24f 20276-162 HUMAN OTC DRUG Lucky Antibacterial Hand Soap Supersoft Triclosan LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc TRICLOSAN .1 mL/100mL 20276-163_c4a1aff4-6cd4-4b71-b229-8d1a69f9d481 20276-163 HUMAN OTC DRUG Lucky Antibacterial Hand Soap Supersoft Triclosan LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc TRICLOSAN .1 mL/100mL 20276-164_15cc8f99-1238-4d26-8052-cb32472d09dd 20276-164 HUMAN OTC DRUG Lucky Antibacterial Hand Soap Supersoft Triclosan LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc TRICLOSAN .1 mL/100mL 20276-165_76768c34-7f97-4cc1-9b28-f843d131045f 20276-165 HUMAN OTC DRUG Antibacterial Hand Soap Triclosan LIQUID TOPICAL 20110930 OTC MONOGRAPH NOT FINAL part333E Delta Brands Inc TRICLOSAN .1 mL/100mL 20276-166_dd7c48f4-30b4-4b78-8a69-d35835362795 20276-166 HUMAN OTC DRUG Lucky Supersoft Antibacterial Hand Triclosan SOAP TOPICAL 20140107 OTC MONOGRAPH NOT FINAL part333A Delta Brands Inc TRICLOSAN .15 g/100mL 20276-200_3125d08e-05b3-4072-ae53-7f6a4e851fb5 20276-200 HUMAN OTC DRUG Lucky Supersoft Oil Free Acne Wash Salicylic Acid LIQUID TOPICAL 20110815 OTC MONOGRAPH FINAL part333D Delta Brands Inc SALICYLIC ACID 2 mL/100mL 20276-210_e3f602b7-eed2-4384-8761-fa74481443be 20276-210 HUMAN OTC DRUG Lucky Blue Ice Menthol Camphor GEL TOPICAL 20091115 OTC MONOGRAPH NOT FINAL part348 Delta Brands Inc CAMPHOR (SYNTHETIC); MENTHOL .5; 1 g/100g; g/100g 20276-321_8d9d0473-ad5b-477f-a172-361241614d4c 20276-321 HUMAN OTC DRUG My Fair Baby Diaper Rash Zinc Oxide CREAM TOPICAL 20110830 OTC MONOGRAPH FINAL part347 Delta Brands Inc ZINC OXIDE 13 g/100g 20276-325_4c4c9857-e9b8-4883-aca1-ecdd6f793448 20276-325 HUMAN OTC DRUG Lucky Itch Stopping Diphenhydramine hydrochloride Zinc acetate CREAM TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part348 Delta Brands Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 20276-430_5cf661ed-5f51-4540-83a5-f8e9b879fefe 20276-430 HUMAN OTC DRUG Lucky Sanitizing Hand Towels Alcohol CLOTH TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333A Delta Brands, Inc ALCOHOL 62 mg/1 20276-431_5707b348-dfca-4e63-896b-08553a105d43 20276-431 HUMAN OTC DRUG Wet Wipes Benzalkonium chloride SWAB TOPICAL 20070123 OTC MONOGRAPH NOT FINAL part333A Delta Brands, Inc BENZALKONIUM CHLORIDE .1 g/1 20276-432_060b5282-99e7-4bc1-b4ce-564a1da0d0ac 20276-432 HUMAN OTC DRUG Wet Wipes Benzethonium chloride SWAB TOPICAL 20110429 OTC MONOGRAPH NOT FINAL part333A Delta Brands, Inc BENZETHONIUM CHLORIDE .3 mL/1 20276-433_8339d4f6-63fd-44aa-9e88-cc3999488802 20276-433 HUMAN OTC DRUG Wet Wipes Benzethonium chloride SWAB TOPICAL 20110529 OTC MONOGRAPH NOT FINAL part333A Delta Brands, Inc BENZETHONIUM CHLORIDE .3 mL/1 20276-505_561115e9-0ca4-4376-af48-07f84f1f5910 20276-505 HUMAN OTC DRUG Petroleum Jelly White Petrolatum OINTMENT TOPICAL 20110530 OTC MONOGRAPH FINAL part347 Delta Brands Inc. PETROLATUM 1 g/g 20276-550_32133238-7a24-4818-a7fb-4e5f844edd1e 20276-550 HUMAN OTC DRUG Lucky Super Soft Sensitive Sodium fluoride Potassium Nitrate PASTE, DENTIFRICE DENTAL 20140227 OTC MONOGRAPH NOT FINAL part356 Delta Brands Inc POTASSIUM NITRATE; SODIUM FLUORIDE 50; 2.4 mg/g; mg/g 20276-551_1366e3db-ba4a-4546-aead-a3165abc7d0a 20276-551 HUMAN OTC DRUG Lucky Super Soft Anti Cavity with Free Toothbrush Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20140227 OTC MONOGRAPH FINAL part355 Delta Brands Inc SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 20276-552_7ff4f3c8-a42b-42d4-9a6e-9b138a9ccad4 20276-552 HUMAN OTC DRUG Lucky Super Soft Whitening Anti Cavity with Free Toothbrush Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20140227 OTC MONOGRAPH FINAL part355 Delta Brands Inc SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 20276-560_00e02dfa-892d-4095-bcee-a3dd2bca05f5 20276-560 HUMAN OTC DRUG My Fair Baby Instant Pain Relief Benzocaine GEL TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part356 Delta Brands Inc BENZOCAINE 7.5 g/100g 20276-561_6d3a3406-d5f3-4d7d-8898-79d9a4682776 20276-561 HUMAN OTC DRUG Lucky Oral Pain Relief Benzocaine Benzalkonium Chloride GEL TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part356 Delta Brands Inc BENZALKONIUM CHLORIDE; BENZOCAINE .1; 20 g/100g; g/100g 20276-814_a22b3be0-204a-4cd7-a2e7-69deb89d114a 20276-814 HUMAN OTC DRUG Petroleum Jelly Scented White Petrolatum OINTMENT TOPICAL 20110530 OTC MONOGRAPH FINAL part347 Delta Brands Inc. PETROLATUM 99.9 g/100g 20276-815_889a4633-7563-4a7a-b464-03e5bca3b7ab 20276-815 HUMAN OTC DRUG Petroleum Jelly Scented White Petrolatum OINTMENT TOPICAL 20130413 OTC MONOGRAPH FINAL part347 Delta Brands Inc. PETROLATUM 99.9 g/100g 20276-979_7229d245-744b-4cbc-b2eb-d8f4653b30bf 20276-979 HUMAN OTC DRUG Lucky Supersoft Premium Menthol Zinc Oxide POWDER TOPICAL 20101025 OTC MONOGRAPH NOT FINAL part348 Delta Brands Inc MENTHOL; ZINC OXIDE .15; 1 g/100g; g/100g 20367-111_cdec2548-5700-447b-9398-2bb70ddbd769 20367-111 HUMAN OTC DRUG Rayito de Sol Sunscreen SPF 6 Octisalate Oxybenzone CREAM TOPICAL 20110214 OTC MONOGRAPH FINAL part352 Siscom de Argentina SA OCTISALATE; OXYBENZONE 2.8; .7 g/70g; g/70g 20367-113_aa6f3dd2-74ab-4c29-b48d-83e9c1d964a9 20367-113 HUMAN OTC DRUG Rayito de Sol Sunscreen SPF 18 Octisalate Oxybenzone Padimate O CREAM TOPICAL 20110214 OTC MONOGRAPH FINAL part352 Siscom de Argentina SA OCTISALATE; OXYBENZONE; PADIMATE O 2.8; 4.2; 4.2 g/70g; g/70g; g/70g 20367-132_a992a8a3-4f24-486c-9243-bdcd6ccf3094 20367-132 HUMAN OTC DRUG Rayito de Sol Ensulizole, Sulisobenzone GEL TOPICAL 20121224 OTC MONOGRAPH FINAL part352 Siscom de Argentina S.A. ENSULIZOLE; SULISOBENZONE 4; 4 g/200g; g/200g 20367-133_5dd84112-9478-4dba-8920-4fb47cbcb4fd 20367-133 HUMAN OTC DRUG Rayito de Sol Ensulizole, Sulisobenzone GEL TOPICAL 20121224 OTC MONOGRAPH FINAL part352 Siscom de Argentina S.A. ENSULIZOLE; SULISOBENZONE 4; 4 g/200g; g/200g 20367-134_ca16f393-2014-40df-9545-14e5858b16ad 20367-134 HUMAN OTC DRUG Rayito de Sol SPF 35 OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20130111 OTC MONOGRAPH FINAL part352 Siscom de Argentina S.A. OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 15.04; 9.68; 7.21; 9.68; 1.24 g/200mL; g/200mL; g/200mL; g/200mL; g/200mL 20479-0682_44a02913-e60b-465d-b5d7-48561c42825f 20479-0682 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Hometown Medical LLC OXYGEN 99 L/100L 20482-001_acf5a0bc-c7e6-45a7-bb84-aca8a2f4dcf8 20482-001 HUMAN PRESCRIPTION DRUG SUBSYS FENTANYL SPRAY SUBLINGUAL 20120313 NDA NDA202788 Insys Therapeutics, Inc. FENTANYL .1 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 20482-002_acf5a0bc-c7e6-45a7-bb84-aca8a2f4dcf8 20482-002 HUMAN PRESCRIPTION DRUG SUBSYS FENTANYL SPRAY SUBLINGUAL 20120313 NDA NDA202788 Insys Therapeutics, Inc. FENTANYL .2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 20482-004_acf5a0bc-c7e6-45a7-bb84-aca8a2f4dcf8 20482-004 HUMAN PRESCRIPTION DRUG SUBSYS FENTANYL SPRAY SUBLINGUAL 20120313 NDA NDA202788 Insys Therapeutics, Inc. FENTANYL .4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 20482-006_acf5a0bc-c7e6-45a7-bb84-aca8a2f4dcf8 20482-006 HUMAN PRESCRIPTION DRUG SUBSYS FENTANYL SPRAY SUBLINGUAL 20120313 NDA NDA202788 Insys Therapeutics, Inc. FENTANYL .6 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 20482-008_acf5a0bc-c7e6-45a7-bb84-aca8a2f4dcf8 20482-008 HUMAN PRESCRIPTION DRUG SUBSYS FENTANYL SPRAY SUBLINGUAL 20120313 NDA NDA202788 Insys Therapeutics, Inc. FENTANYL .8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 20482-012_acf5a0bc-c7e6-45a7-bb84-aca8a2f4dcf8 20482-012 HUMAN PRESCRIPTION DRUG SUBSYS FENTANYL SPRAY SUBLINGUAL 20120830 NDA NDA202788 Insys Therapeutics, Inc. FENTANYL .6 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 20482-016_acf5a0bc-c7e6-45a7-bb84-aca8a2f4dcf8 20482-016 HUMAN PRESCRIPTION DRUG SUBSYS FENTANYL SPRAY SUBLINGUAL 20120830 NDA NDA202788 Insys Therapeutics, Inc. FENTANYL .8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 20536-322_a6ac9d15-6436-4c92-8c81-b16d7d0a8598 20536-322 HUMAN PRESCRIPTION DRUG Marqibo Vincristine Sulfate KIT 20130114 NDA NDA202497 Talon Therapeutics, Inc 20703-001_1d9b3364-16ae-481e-993d-dbe143100c8a 20703-001 HUMAN PRESCRIPTION DRUG nitrogen nitrogen GAS RESPIRATORY (INHALATION) 19840101 UNAPPROVED MEDICAL GAS General Welding Supply Corp. NITROGEN 999 mL/L 20703-002_2354da7f-d0a7-442d-873b-05b6453a12ea 20703-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19840101 UNAPPROVED MEDICAL GAS General Welding Supply Corp. OXYGEN 995 mL/L 20703-003_1c082c28-39eb-4099-a727-fbf8f4e812be 20703-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19840101 UNAPPROVED MEDICAL GAS General Welding Supply Corp. NITROUS OXIDE 990 mL/L 20802-1500_89aaa721-8b3c-4167-8758-d5e41d05a430 20802-1500 HUMAN OTC DRUG Fresh Protect Skin Sanitizer Benzalkonium Chloride LOTION TOPICAL 20101216 OTC MONOGRAPH NOT FINAL part333A Omega Tech Labs Inc. BENZALKONIUM CHLORIDE .0013 g/mL 20802-1501_f3475182-3cd1-44b2-be07-cbcb554f4b55 20802-1501 HUMAN OTC DRUG Fresh Protect Skin Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20101216 OTC MONOGRAPH NOT FINAL part333A Omega Tech Labs Inc. BENZALKONIUM CHLORIDE .001 g/mL 20802-1502_a7159bc5-8b7a-4763-8c90-3182be730f87 20802-1502 HUMAN OTC DRUG Fresh Protect Skin Sanitizer Benzalkonium Chloride SPRAY TOPICAL 20101216 OTC MONOGRAPH NOT FINAL part333A Omega Tech Labs Inc. BENZALKONIUM CHLORIDE .001 g/mL 20802-1503_f3475182-3cd1-44b2-be07-cbcb554f4b55 20802-1503 HUMAN OTC DRUG Fresh Protect Skin Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20101216 OTC MONOGRAPH NOT FINAL part333A Omega Tech Labs Inc. BENZALKONIUM CHLORIDE .001 g/mL 20890-0020_6cc082b1-ae18-49ed-a51b-d1c5c28792ee 20890-0020 HUMAN OTC DRUG Lander Polar Ice Menthol GEL TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part356 Abaco Partners LLC DBA Surefil MENTHOL 20 mg/g 20890-0050_c151a0dc-d02b-41bd-8aae-55bc2497f6e7 20890-0050 HUMAN OTC DRUG TopCare Amber Antibacterial Hand Benzalkonium Chloride SOAP TOPICAL 20141215 OTC MONOGRAPH NOT FINAL part333E Abaco Partners LLC DBA Surefil BENZALKONIUM CHLORIDE 13 mg/10mL 21130-001_f3039536-0d87-41ff-abea-7df451bbb56e 21130-001 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20050711 ANDA ANDA075217 Safeway IBUPROFEN 50 mg/1.25mL 21130-002_90f7547d-39ec-437d-8ea2-0b46e3feac94 21130-002 HUMAN OTC DRUG enema Saline ENEMA RECTAL 20091210 OTC MONOGRAPH NOT FINAL part334 Safeway SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 21130-003_e4847637-95c0-41a5-a424-dec6a536d2f8 21130-003 HUMAN OTC DRUG Acid Reducer Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20131213 ANDA ANDA201745 SAFEWAY INC. RANITIDINE HYDROCHLORIDE 75 mg/1 21130-005_462a4ff2-2ca1-4540-9270-e93abbe29aff 21130-005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 Safeway SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 21130-008_330f30d1-4626-4d2e-a4b8-5e884364f1c4 21130-008 HUMAN OTC DRUG infants concentrated aspirin free Acetaminophen SUSPENSION/ DROPS ORAL 19970917 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 80 mg/.8mL 21130-009_2801fe00-44cd-4df5-ac88-c66456707df6 21130-009 HUMAN OTC DRUG 4 Hour Allergy Relief Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Safeway CHLORPHENIRAMINE MALEATE 4 mg/1 21130-010_0b6848dd-e959-4833-b986-6ff456188298 21130-010 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET, COATED ORAL 20060125 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 500 mg/1 21130-013_ad070574-874f-47a5-a605-41018e56c84c 21130-013 HUMAN OTC DRUG allergy and congestion relief Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20121018 ANDA ANDA076050 Safeway LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 21130-019_ef523ae9-f41b-4faf-8a6f-6cd4538e6be1 21130-019 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20121231 ANDA ANDA202727 Safeway, Inc. LANSOPRAZOLE 15 mg/1 21130-024_635b9d72-d683-4164-a157-bdac9d775c40 21130-024 HUMAN OTC DRUG Childrens Mucus Relief DM Dextromethorphan HBr, Guaifensin LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 21130-025_afb3bacb-1b7a-4f0d-9043-92d9bef54861 21130-025 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20090203 OTC MONOGRAPH FINAL part341 Safeway, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 21130-029_6de3347d-adad-4f6e-a8bd-cc5f1a90299f 21130-029 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20060814 ANDA ANDA076775 Safeway NICOTINE 2 mg/1 21130-036_7d2689c5-4a4a-4913-aeb1-6d3005ccfe89 21130-036 HUMAN OTC DRUG Cold Flu and Sore Throat Relief Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL 21130-044_fd3f636c-3ce7-423f-954d-c63c558a9c48 21130-044 HUMAN OTC DRUG Nighttime Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 21130-047_cdb02ab2-476f-40b4-92ec-9c918a2f1e90 21130-047 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20080220 ANDA ANDA078653 Safeway RANITIDINE HYDROCHLORIDE 150 mg/1 21130-049_0005e125-fbf2-4f90-8960-99e00250fc20 21130-049 HUMAN OTC DRUG Pain Relief Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20060911 OTC MONOGRAPH NOT FINAL part348 Safeway CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g 21130-050_763d385a-227a-4f7f-928e-85f0d74b26dd 21130-050 HUMAN OTC DRUG ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090220 ANDA ANDA079113 Safeway DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 21130-053_025edd6f-d9d8-4b12-8672-47b1a90b7754 21130-053 HUMAN OTC DRUG SAFEWAY CARE HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20131213 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC ALCOHOL 650 mg/mL 21130-053_c3f61513-d6f4-4e16-a459-df346c7e460f 21130-053 HUMAN OTC DRUG SAFEWAY CARE HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC ALCOHOL 650 mg/mL 21130-053_f8b2384a-c357-42fc-8eeb-99b419acf8af 21130-053 HUMAN OTC DRUG SAFEWAY CARE HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20131231 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC ALCOHOL 650 mg/mL 21130-054_aec6d20f-79f2-4364-9b32-0ec6030b7bad 21130-054 HUMAN OTC DRUG 12 hour nasal decongestant non drowsy Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000525 ANDA ANDA075153 Safeway PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 21130-063_3b2686fe-8679-47af-8fb5-0467f7515713 21130-063 HUMAN OTC DRUG SAFEWAY Hydrocortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Safeway Inc. HYDROCORTISONE 1 g/100g 21130-065_149eb141-f4cf-4cad-a019-b3382758e7b6 21130-065 HUMAN OTC DRUG nasal decongestant Oxymetazoline HCl SPRAY NASAL 19940817 OTC MONOGRAPH FINAL part341 Safeway OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 21130-067_d092af41-b871-4c41-8e0e-9818f1262c93 21130-067 HUMAN OTC DRUG triple antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20050907 OTC MONOGRAPH FINAL part333B Safeway BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 21130-069_c6f74fda-84c4-48dd-ad13-12e6ff9ed352 21130-069 HUMAN OTC DRUG Pure petroleum White Petrolatum JELLY TOPICAL 19890715 OTC MONOGRAPH FINAL part347 Safeway Inc PETROLATUM 1 g/g 21130-072_6224509f-cda4-406e-8fc0-c000d9754d68 21130-072 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19980325 OTC MONOGRAPH NOT FINAL part356 Safeway, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 21130-075_32493b4c-9b11-4fe8-bc92-5c1ff4c2e976 21130-075 HUMAN OTC DRUG Safeway Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Safeway Inc. BACITRACIN ZINC 500 [iU]/g 21130-076_73ba9788-7b61-444d-aee1-67b896dc3c57 21130-076 HUMAN OTC DRUG Safeway Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Safeway Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g 21130-080_696060f2-0fe7-4f4d-a9ed-513c4ec083f3 21130-080 HUMAN OTC DRUG Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Safeway Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g 21130-083_bad190f1-22fe-4d2e-9a6f-7cb91ec2f2c6 21130-083 HUMAN OTC DRUG cold and sinus pain relief Ibuprofen, Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011030 ANDA ANDA074567 Safeway IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 21130-084_028efc97-e5e7-4ddc-8716-4bb4930113c5 21130-084 HUMAN OTC DRUG SAFEWAY CARE ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131231 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC ALCOHOL 650 mg/mL 21130-084_388d526d-9a60-41a5-abb8-e6a286127193 21130-084 HUMAN OTC DRUG SAFEWAY CARE ALOE ETHYL ALCOHOL LIQUID TOPICAL 20140122 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC ALCOHOL 650 mg/mL 21130-084_e6f38082-ae9c-4fc8-9bc9-5ec1b97f053c 21130-084 HUMAN OTC DRUG SAFEWAY CARE ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131124 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC ALCOHOL 650 mg/mL 21130-092_4d6de021-4cb0-4ae5-baf3-a9eb2967f43c 21130-092 HUMAN OTC DRUG Childrens Non-Drowsy 24-Hour Allergy Relief Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Safeway Inc. LORATADINE 5 mg/5mL 21130-094_624c0e56-b21f-4cf4-987e-d40661322a43 21130-094 HUMAN OTC DRUG SAFEWAY CARE REFILL TRICLOSAN LIQUID TOPICAL 20131124 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC TRICLOSAN 1.5 mg/mL 21130-096_b43d6872-9bbf-4d8f-b948-dbda09920c21 21130-096 HUMAN OTC DRUG Flu and Severe Cold and Cough Daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20120117 OTC MONOGRAPH FINAL part341 Safeway ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 21130-104_50bd2aed-2711-431e-b884-39a501587ba3 21130-104 HUMAN OTC DRUG Aspirin Free Pain Relief Acetaminophen TABLET ORAL 19900713 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 325 mg/1 21130-106_a61f8e41-c57c-489f-8eb6-edd01fc6b6ff 21130-106 HUMAN OTC DRUG Safeway Children Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Safeway Inc. CETIRIZINE HYDROCHLORIDE 5 mg/5mL 21130-107_f7625dcb-2f76-4fb7-a4e7-4eea0a1e6165 21130-107 HUMAN OTC DRUG triple antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20141223 OTC MONOGRAPH FINAL part333B Safeway BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP&apos'U]/g; mg/g; [USP&apos'U]/g 21130-113_9431c02d-28d1-4551-b8c6-66d3d4fcd651 21130-113 HUMAN OTC DRUG Night Time Cherry Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090123 OTC MONOGRAPH FINAL part341 Safeway ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 21130-117_46a8e3c8-34b2-46f0-b493-18b09ea753d6 21130-117 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20141007 ANDA ANDA202319 Safeway LANSOPRAZOLE 15 mg/1 21130-133_085c0797-532a-4693-9a20-0af042ebea72 21130-133 HUMAN OTC DRUG Flu and Sore Throat acetaminophen,pheniramine maleate, phenylephrine hydrochloride POWDER, FOR SUSPENSION ORAL 20100909 OTC MONOGRAPH FINAL part341 Safeway ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/15000mg; mg/15000mg; mg/15000mg 21130-140_d91f51fc-c6d0-44f6-8b90-09576f13f0d4 21130-140 HUMAN OTC DRUG pain relief all day Naproxen sodium TABLET, FILM COATED ORAL 20081003 ANDA ANDA074661 Safeway NAPROXEN SODIUM 220 mg/1 21130-141_96c0dcaa-ca0a-4e15-a140-97118460adb6 21130-141 HUMAN OTC DRUG acid controller original strength Famotidine TABLET ORAL 20091213 ANDA ANDA075400 Safeway FAMOTIDINE 10 mg/1 21130-148_5b1f158e-73ab-48be-b34e-166ebefa3ced 21130-148 HUMAN OTC DRUG Triacting Day Time with PE DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20090402 OTC MONOGRAPH FINAL part341 Safeway, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 21130-152_575d79b2-68ba-4af4-938c-77b135712e83 21130-152 HUMAN OTC DRUG Triacting Night Time DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20090323 OTC MONOGRAPH FINAL part341 Safeway DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 21130-156_2eb3c1bf-e939-4828-b945-1df4bca43ee7 21130-156 HUMAN OTC DRUG Cough Relief DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20090108 OTC MONOGRAPH FINAL part341 Safeway DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 21130-157_7fe28b94-acd4-43ef-b6a5-e6e5ae4c715a 21130-157 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20060210 OTC MONOGRAPH NOT FINAL part343 Safeway ASPIRIN 325 mg/1 21130-159_91701c07-8d3d-4a1d-80b8-f2ba41e3f0c5 21130-159 HUMAN OTC DRUG Added Strength Pain Reliever Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 21130-160_bb60cff3-588d-460e-bd30-42dcdc20fcce 21130-160 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20121113 OTC MONOGRAPH FINAL part346 Safeway COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g 21130-161_d29a798c-57a2-4e46-8ee3-6bab068b9a34 21130-161 HUMAN OTC DRUG Aspirin free Acetaminophen LIQUID ORAL 20110810 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 160 mg/5mL 21130-170_63e1a4e6-50f1-46e5-8bca-6d43621a4c85 21130-170 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20060817 ANDA ANDA076789 Safeway NICOTINE 4 mg/1 21130-175_c6e14caa-356f-4426-bc90-531b65dafce0 21130-175 HUMAN OTC DRUG aspirin free Acetaminophen SUSPENSION ORAL 19971130 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 160 mg/5mL 21130-188_a0dd2ebd-b57f-40ad-9ddd-66053ccec7fa 21130-188 HUMAN OTC DRUG Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20131121 OTC MONOGRAPH FINAL part346 Safeway MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 21130-190_cb263220-94b7-40fa-877e-d75a809a94b8 21130-190 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 Safeway DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 21130-194_0e69201c-c725-4a07-9977-e5d230cb857b 21130-194 HUMAN OTC DRUG Acid Controller Maximum Strength Famotidine TABLET ORAL 20070615 ANDA ANDA077351 Safeway FAMOTIDINE 20 mg/1 21130-197_eb442ac5-4553-4876-aca1-a9957203c81c 21130-197 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100706 ANDA ANDA078682 Safeway, Inc. IBUPROFEN 200 mg/1 21130-198_c27f60ca-deb3-4fd8-826d-aba2cbf0f518 21130-198 HUMAN OTC DRUG Motion Sickness Relief Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 Safeway DIMENHYDRINATE 50 mg/1 21130-199_8a760b42-e578-48f6-a885-71bf82e78dc2 21130-199 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100830 ANDA ANDA079114 Safeway 21130-204_f6c37c90-f28a-4a7f-93b4-55ac87b828d4 21130-204 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Safeway Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 21130-214_29db09f4-8aa5-4b4d-a409-34c5d6b4b0e7 21130-214 HUMAN OTC DRUG miconazole 7 Miconazole nitrate CREAM VAGINAL 19990908 ANDA ANDA074760 Safeway MICONAZOLE NITRATE 2 g/100g 21130-217_fd658f54-4efd-4b40-877b-f51eb6abcfe3 21130-217 HUMAN OTC DRUG pain relief 8 hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101122 ANDA ANDA075077 Safeway ACETAMINOPHEN 650 mg/1 21130-218_97611643-48ef-4507-84c6-53ca7a33ea4c 21130-218 HUMAN OTC DRUG Aspiring Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 Safeway ASPIRIN 81 mg/1 21130-225_71a41089-11f3-44e5-be4a-10b013b75964 21130-225 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130531 OTC MONOGRAPH FINAL part338 Safeway, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 21130-226_59b29e73-8d2a-4916-b921-4a7c079ab1bf 21130-226 HUMAN OTC DRUG Maximum Strength Stay Awake Caffeine TABLET ORAL 19921121 OTC MONOGRAPH FINAL part340 Safeway CAFFEINE 200 mg/1 21130-230_2ca3a112-bf49-4618-a77c-cc6cb1da8668 21130-230 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130430 OTC MONOGRAPH FINAL part341 Safeway, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 21130-235_018bfaa7-9786-4415-b6fb-f6d14209b3f7 21130-235 HUMAN OTC DRUG Extra Strength Pain Relief PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 21130-236_da59bbd2-ffcd-4217-8786-c9ba7259f37d 21130-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 Safeway, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 21130-238_da239d83-52a0-4410-a5b0-6fd9cd9521d0 21130-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 Safeway, Inc. DOCUSATE SODIUM 100 mg/1 21130-240_a213c774-4879-46ec-8ebc-c6e7283df139 21130-240 HUMAN OTC DRUG FOAMING HAND SANITIZER WITH ALOE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part333 SAFEWAY INC BENZALKONIUM CHLORIDE .1 mL/100mL 21130-242_e5ef1045-83a2-457b-ba52-128075052206 21130-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH FINAL part347 Safeway, Inc. DIMETHICONE 125 mg/1 21130-248_469593a3-3e2c-4801-ab5e-46b4e9f543e2 21130-248 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20090105 OTC MONOGRAPH FINAL part341 Safeway CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100kg; kg/100kg 21130-252_e4a2ca3d-7944-43cd-a441-a515c93f5407 21130-252 HUMAN OTC DRUG Safeway Instant Hand Sanitizing wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Safeway Inc. ALCOHOL .659 mL/mL 21130-253_4fd3cfd3-f150-4fce-bec2-52b3367232d1 21130-253 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20100202 OTC MONOGRAPH NOT FINAL part333 SAFEWAY INC ALCOHOL 65 mL/100mL 21130-254_33300d27-ca28-4c1f-892a-5c2cafea6a4b 21130-254 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH ALOE ETHYL ALCOHOL GEL TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 SAFEWAY INC ALCOHOL 65 mL/100mL 21130-255_81f1502c-9f9d-4d0a-892d-bed0afcb9d2e 21130-255 HUMAN OTC DRUG SAFEWAY ETHYL ALCOHOL LIQUID TOPICAL 20111213 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC ALCOHOL 65 mL/100mL 21130-271_fa488c44-7e42-42d9-b457-d4a9b944f955 21130-271 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20090529 ANDA ANDA076760 Safeway RANITIDINE HYDROCHLORIDE 75 mg/1 21130-279_56a1ce72-8e54-4eb2-9c6e-eb479e7633a1 21130-279 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141007 OTC MONOGRAPH FINAL part346 Safeway COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 21130-289_3ce3b182-f500-4bb5-9f32-8173c30a4126 21130-289 HUMAN OTC DRUG concentrated aspirin free infants Acetaminophen SUSPENSION/ DROPS ORAL 19970730 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 80 mg/.8mL 21130-291_e2748718-5acc-45ee-8879-97d9539073af 21130-291 HUMAN OTC DRUG anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 20070730 UNAPPROVED DRUG OTHER Safeway DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 21130-292_f0d07b14-d538-43fb-9802-aea6b06ee4e4 21130-292 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 Safeway IBUPROFEN 200 mg/1 21130-294_fbcce930-35ca-4feb-85f5-60986137ccf3 21130-294 HUMAN OTC DRUG SAFEWAY TRICLOSAN LIQUID TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC. TRICLOSAN .15 mL/100mL 21130-296_7dcd78cb-61d1-4955-9bec-ede2a38d31e4 21130-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 19981208 OTC MONOGRAPH FINAL part358H Safeway, Inc PYRITHIONE ZINC 14 mg/mL 21130-298_91d7a6d4-68a4-44b4-bc34-e668b7c0ea29 21130-298 HUMAN OTC DRUG Vegetable Laxative Sennosides TABLET ORAL 19950127 OTC MONOGRAPH NOT FINAL part334 Safeway SENNOSIDES A AND B 8.6 mg/1 21130-299_dbd80080-5f5e-480c-97eb-d8c7f3402beb 21130-299 HUMAN OTC DRUG Mint Cetylpyridinium Chloride MOUTHWASH ORAL 20090529 OTC MONOGRAPH NOT FINAL part356 Safeway, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL 21130-304_0e0eb1e3-35e4-4211-a10f-1e1f3c31e82c 21130-304 HUMAN OTC DRUG Nasal Decongestant oxymetazoline hydrochloride SPRAY NASAL 20140305 OTC MONOGRAPH FINAL part341 Safeway OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 21130-306_75a6d469-8993-4ec5-b5cd-d6ab7445eb83 21130-306 HUMAN OTC DRUG clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 Safeway POLYETHYLENE GLYCOL 3350 17 g/17g 21130-311_c6d23c8f-42d9-4b2d-9a59-1a5ba432555c 21130-311 HUMAN OTC DRUG Daytime Cold and Flu Relief Non Drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 21130-312_e6f632c0-8a36-4fde-ba70-033a0bcfd97e 21130-312 HUMAN OTC DRUG childrens cold and allergy relief Brompheniramine maleate, Phenylephrine HCl LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 21130-314_e0c9cd5f-e37e-4920-a765-2d501d82ab46 21130-314 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 19971130 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 160 mg/5mL 21130-318_43b53fc7-1718-4e6f-8428-908e93fa0768 21130-318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 19900715 OTC MONOGRAPH NOT FINAL part356 Safeway Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 21130-320_27982fb4-6a8d-4fb4-952b-bbc00e923370 21130-320 HUMAN OTC DRUG SAFEWAY DIMETHICONE LOTION TOPICAL 20120103 OTC MONOGRAPH FINAL part347 SAFEWAY INC. DIMETHICONE 1.25 mL/100mL 21130-321_08a5a2de-374d-4cc7-af7a-68ab66423f0a 21130-321 HUMAN OTC DRUG acid controller complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080806 ANDA ANDA077355 Safeway CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 21130-326_63bbe644-d54c-4aca-92f6-280531309c55 21130-326 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20050212 OTC MONOGRAPH NOT FINAL part334 Safeway BISACODYL 5 mg/1 21130-327_4b7db120-1f0a-4aa0-acd0-4dc0dabcaf83 21130-327 HUMAN OTC DRUG Laxative Bisacodyl TABLET ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 Safeway BISACODYL 5 mg/1 21130-328_9de2a072-b1e2-4886-8657-0d622a1cf98f 21130-328 HUMAN OTC DRUG sore throat spray Phenol SPRAY ORAL 19930811 OTC MONOGRAPH NOT FINAL part356 Safeway PHENOL 1.4 mL/100mL 21130-329_80164c17-4bd1-4a30-886d-260ce0a659b5 21130-329 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 Safeway DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 21130-330_327e6873-ba0d-4021-9adc-b356e2b5b538 21130-330 HUMAN OTC DRUG SAFEWAY PETROLATUM JELLY TOPICAL 20120103 OTC MONOGRAPH FINAL part346 SAFEWAY INC. PETROLATUM 41 g/100g 21130-332_dadbfabf-ade9-4ff6-b94f-58249565a4f9 21130-332 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide LIQUID ORAL 19970819 OTC MONOGRAPH NOT FINAL part334 Safeway MAGNESIUM HYDROXIDE 1200 mg/15mL 21130-336_106ff398-7ae3-4eae-bd7d-a8ac2e0254fd 21130-336 HUMAN OTC DRUG Arthritis 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Safeway Inc. ACETAMINOPHEN 650 mg/1 21130-338_357e9351-44ce-4575-83ad-9855c618e99a 21130-338 HUMAN OTC DRUG DM Max Relief Maximum Strength dextromethorphan hydrobromide, guaifenesin LIQUID ORAL 20140731 OTC MONOGRAPH FINAL part341 Safeway, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL 21130-340_32b016aa-dfb2-417d-b508-94d1ccd221bf 21130-340 HUMAN OTC DRUG antacid plus gas relief aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 19960425 OTC MONOGRAPH FINAL part331 Safeway ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 21130-343_5391d8b1-2f62-4813-80d2-24d239036560 21130-343 HUMAN OTC DRUG Nighttime Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 21130-344_3bd039f9-5f0f-486f-be4c-6a4347e11e0a 21130-344 HUMAN OTC DRUG nicotine Nicotine Polacrilex LOZENGE ORAL 20060406 ANDA ANDA077007 Safeway NICOTINE 2 mg/1 21130-352_ff917719-5a59-4e50-8861-81ce54e29d4b 21130-352 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20080122 ANDA ANDA078547 Safeway NICOTINE 2 mg/1 21130-355_10b8619a-69ae-48b5-a07a-4584a95934a9 21130-355 HUMAN OTC DRUG Sinus Relief Daytime Acetaminophen, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20070822 OTC MONOGRAPH FINAL part341 Safeway ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 21130-357_2f484a6d-fa4b-43cb-8b96-8d3cb8276f4d 21130-357 HUMAN OTC DRUG antacid plus gas relief regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19931022 OTC MONOGRAPH FINAL part331 Safeway ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 21130-367_5c797c7c-54ec-4535-99cd-78323d0c6b54 21130-367 HUMAN OTC DRUG Nighttime Sleep Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 Safeway DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 21130-368_5a4a898c-dd8a-47bd-95b0-9e33eb6cdb6a 21130-368 HUMAN OTC DRUG pain relief all day Naproxen Sodium TABLET, FILM COATED ORAL 20070912 ANDA ANDA074661 Safeway NAPROXEN SODIUM 220 mg/1 21130-370_358f860e-8090-40cc-bde4-8fae6ddd24f9 21130-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20140906 OTC MONOGRAPH NOT FINAL part333A Safeway Inc. ALCOHOL 70 mL/100mL 21130-373_286e90c1-5401-4c24-8127-c78b9ffef3d5 21130-373 HUMAN OTC DRUG Pain Reliever PM Acetaminophen and Diphenhydramine Citrate TABLET ORAL 20040607 OTC MONOGRAPH FINAL part341 Safeway ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 21130-374_29971b81-e787-438e-bc69-99e45841c8f6 21130-374 HUMAN OTC DRUG migraine formula Acetaminophen, Aspirin, Caffeine TABLET ORAL 20020507 ANDA ANDA075794 Safeway ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 21130-375_72f7b056-28c8-4324-8322-693bb56c7f96 21130-375 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl CAPSULE ORAL 20050503 ANDA ANDA076497 Safeway LOPERAMIDE HYDROCHLORIDE 2 mg/1 21130-382_1901c260-7364-4cb3-b295-e9a85acc131b 21130-382 HUMAN OTC DRUG Multi Symptom Cold Relief CF Non Drowsy Dextromethorphan HBr, Guaifenesin, Phenylephrine LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 21130-383_3c7d5c70-cd5e-4eb4-9a56-77fc9a9a26c1 21130-383 HUMAN OTC DRUG Adult Cough Relief DM Dextromethorphan HBr LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 21130-384_e74f4329-0973-4bfc-83f6-f96d8609e15b 21130-384 HUMAN OTC DRUG cough dm dextromethorphan polistirex SUSPENSION ORAL 20120828 ANDA ANDA091135 Safeway DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 21130-385_3d4e0b51-32db-40c1-ac15-b148b6eaa077 21130-385 HUMAN OTC DRUG Adult Cough and Chest Congestion Relief DM Non Drowsy Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 21130-386_6f3a24b6-9cb2-4a94-96bc-f0501641cb23 21130-386 HUMAN OTC DRUG Nighttime Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 Safeway DOXYLAMINE SUCCINATE 25 mg/1 21130-388_eb5847c2-506f-4e62-b13b-df4bd85aac8e 21130-388 HUMAN OTC DRUG nasal decongestant Oxymetazoline HCl SPRAY NASAL 20040607 OTC MONOGRAPH FINAL part341 Safeway OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 21130-390_d0492787-3eec-4f41-8955-180fa359efdb 21130-390 HUMAN OTC DRUG Maximum Strength Menstrual Relief Acetaminophen, Caffeine and Pyrilamine maleate CAPSULE ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 21130-391_ccf5682f-7dc5-4d93-8232-680571264cd0 21130-391 HUMAN OTC DRUG Menstrual Relief Acetaminophen, Caffeine, Pyrilamine maleate CAPSULE, LIQUID FILLED ORAL 20010614 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 21130-393_b595ffc1-3833-4496-8211-60240d52ca8f 21130-393 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, COATED ORAL 20020408 ANDA ANDA075139 Safeway IBUPROFEN 200 mg/1 21130-400_c249615a-65a3-49bb-a512-445d18ccf125 21130-400 HUMAN OTC DRUG Hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 19960731 OTC MONOGRAPH FINAL part346 Safeway MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 21130-402_d03bc0b5-9df5-47e5-a8fd-793567a4687b 21130-402 HUMAN OTC DRUG Cough Relief dextromethorphan polistirex SUSPENSION ORAL 20140318 ANDA ANDA091135 Safeway DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 21130-403_27e2ba88-1016-47ca-b842-4716bd332dfa 21130-403 HUMAN OTC DRUG pain relief regular strength Acetaminophen TABLET ORAL 20000612 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 325 mg/1 21130-404_5dd4a0c0-d0c6-eb3a-acd9-8345fa8267e4 21130-404 HUMAN OTC DRUG Acid Reducer 150 Ranitidine Hydrochloride Tablets 150mg TABLET, COATED ORAL 20120514 ANDA ANDA078192 Safeway Inc RANITIDINE HYDROCHLORIDE 150 mg/1 21130-407_e1968592-9231-4ff6-a645-199903f582d1 21130-407 HUMAN OTC DRUG Safeway Cold Sore Treatment Camphor CREAM TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part348 Safeway BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g 21130-412_dfed9355-9be3-4ae0-8426-a924519c2648 21130-412 HUMAN OTC DRUG SAFEWAY DANDRUFF CLASSIC CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20120103 OTC MONOGRAPH FINAL part358H SAFEWAY INC. PYRITHIONE ZINC 1 mL/100mL 21130-413_7e54aa57-44b5-4701-82d1-177aba49a3c1 21130-413 HUMAN OTC DRUG SAFEWAY DANDRUFF CLASSIC CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20120413 OTC MONOGRAPH FINAL part358H SAFEWAY INC. PYRITHIONE ZINC 1 mL/100mL 21130-414_a91d8f9f-e28a-4fde-b224-90fd0af59eb0 21130-414 HUMAN OTC DRUG Adult Low Strength Aspirin Aspirin TABLET, COATED ORAL 20040114 OTC MONOGRAPH NOT FINAL part343 Safeway ASPIRIN 81 mg/1 21130-415_5bc78bff-931d-4221-b3af-727e44bc0e59 21130-415 HUMAN OTC DRUG SAFEWAY DANDRUFF PYRITHIONE ZINC LIQUID TOPICAL 20120413 OTC MONOGRAPH FINAL part358H SAFEWAY INC. PYRITHIONE ZINC 1 mL/100mL 21130-415_d4adacf4-95b1-4955-9034-82588b195dcf 21130-415 HUMAN OTC DRUG SAFEWAY DANDRUFF PYRITHIONE ZINC LIQUID TOPICAL 20120103 OTC MONOGRAPH FINAL part358H SAFEWAY INC. PYRITHIONE ZINC 1 mL/100mL 21130-416_db7d8507-aa48-4ba5-b14a-a907b07c71bc 21130-416 HUMAN OTC DRUG SAFEWAY DANDRUFF DRY SCALP PYRITHIONE ZINC SHAMPOO TOPICAL 20120528 OTC MONOGRAPH FINAL part358H SAFEWAY INC. PYRITHIONE ZINC 1 mL/100mL 21130-419_19541dc7-84f2-43f4-b41a-6b35336c0fb0 21130-419 HUMAN OTC DRUG DayTime NightTime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. 21130-423_4b53d5f0-b910-4280-8034-ac1c95a9dd65 21130-423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Safeway Inc. IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 21130-424_c9154821-606d-4c5d-b361-c3b90d42500c 21130-424 HUMAN OTC DRUG SAFEWAY CARE NORMAL TO OILY HAIR PYRITHIONE ZINC LIQUID TOPICAL 20131120 OTC MONOGRAPH FINAL part358H SAFEWAY INC PYRITHIONE ZINC 10 mg/mL 21130-426_2d3cb2d4-3a80-4c5c-b205-ee69b277283a 21130-426 HUMAN OTC DRUG SAFEYWAY CARE NORMAL TO OILY HAIR PYRITHIONE ZINC LIQUID TOPICAL 20131126 OTC MONOGRAPH FINAL part358H SAFEWAY INC PYRITHIONE ZINC 10 mg/mL 21130-427_2ce24652-a9b2-4f29-8738-d57233e7282e 21130-427 HUMAN OTC DRUG SAFEWAY CARE DANDRUFF PYRITHIONE ZINC LIQUID TOPICAL 20131213 OTC MONOGRAPH FINAL part358H SAFEWAY INC PYRITHIONE ZINC 10 mg/mL 21130-432_ae64add0-7a51-4f2e-a770-89c2d345fc5f 21130-432 HUMAN OTC DRUG nasal decongestant maximum strength non drowsy Pseudoephedrine HCl TABLET, FILM COATED ORAL 19870715 OTC MONOGRAPH FINAL part341 Safeway PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 21130-437_36ce910a-320c-44e6-89f8-eaf3e1419ba0 21130-437 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20000612 OTC MONOGRAPH FINAL part338 Safeway ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 21130-439_584abe8c-41d6-43f0-93e0-16f88c1f6825 21130-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140910 OTC MONOGRAPH NOT FINAL part333A Safeway Inc. ALCOHOL 700 mg/mL 21130-445_d4224e04-32d4-4aca-a151-7040501d470f 21130-445 HUMAN OTC DRUG Extra Strength Aspirin Free Pain Relief Acetaminophen CAPSULE ORAL 20050210 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 500 mg/1 21130-447_e1e68205-a7c3-4d60-93b0-4699f36a4796 21130-447 HUMAN OTC DRUG Childrens Aspirin Free Rapid Tabs Acetaminophen TABLET, CHEWABLE ORAL 20050203 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 80 mg/1 21130-450_d71b455d-44ea-413b-9261-5a454a3bd20d 21130-450 HUMAN OTC DRUG Junior Aspirin Free Rapid Tabs Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 160 mg/1 21130-453_7485df45-a20f-4c64-90ae-887356a1deb9 21130-453 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine HCl TABLET ORAL 20041206 OTC MONOGRAPH FINAL part341 Safeway PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 21130-456_936bb7d1-3a15-4e35-850f-e575424b2c79 21130-456 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070718 ANDA ANDA076777 Safeway NICOTINE 2 mg/1 21130-458_4c103c20-08c9-41f2-9617-875a90e9b4b0 21130-458 HUMAN OTC DRUG Allergy Relief 24 hour Cetirizine Hydrochloride TABLET ORAL 20080215 ANDA ANDA078336 Safeway CETIRIZINE HYDROCHLORIDE 10 mg/1 21130-461_48ddd3d8-98bf-444f-b063-275269ce30af 21130-461 HUMAN OTC DRUG FRESH DECOR BASIL GREEN TEA ETHYL ALCOHOL LIQUID TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC. ALCOHOL 65 mL/100mL 21130-462_0e4ef402-2a7c-4af8-81bd-1870958e22f6 21130-462 HUMAN OTC DRUG FRESH DECOR LEMON VERBENA ETHYL ALCOHOL LIQUID TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC. ALCOHOL 65 mL/100mL 21130-463_3ae9b53a-ea2d-4e26-b2d5-231e04f6f9f5 21130-463 HUMAN OTC DRUG FRESH DECOR CITRUS POMEGRANATE ETHYL ALCOHOL LIQUID TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC. ALCOHOL 65 mL/100mL 21130-464_80492ca8-7d73-47ed-95df-d9ddfb3244cf 21130-464 HUMAN OTC DRUG FRESH DECOR COCONUT CREAM ETHYL ALCOHOL LIQUID TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC. ALCOHOL 65 mL/100mL 21130-470_8ef35553-c6e2-4115-880b-334d868d033e 21130-470 HUMAN OTC DRUG Safeway Daytime Cold and Flu Relief ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED ORAL 20121108 OTC MONOGRAPH FINAL part341 Safeway ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 21130-471_eb43120d-f346-4dbd-a526-6d27ccb5b53b 21130-471 HUMAN OTC DRUG Daytime Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130715 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 21130-473_98cc033f-ca51-4953-ab5d-8eb579a1f09a 21130-473 HUMAN OTC DRUG day time cough Dextromethorphan HBr LIQUID ORAL 20070814 OTC MONOGRAPH FINAL part341 Safeway DEXTROMETHORPHAN HYDROBROMIDE 15 mg/15mL 21130-477_13385120-ec0a-4bf5-9363-f3266f1af83f 21130-477 HUMAN OTC DRUG fiber laxative Calcium polycarbophil TABLET, FILM COATED ORAL 20070611 OTC MONOGRAPH NOT FINAL part334 Safeway CALCIUM POLYCARBOPHIL 625 mg/1 21130-480_d36770ed-9370-46a8-bae6-20bc2c95ce00 21130-480 HUMAN OTC DRUG Safeway Nighttime Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20121129 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 21130-484_ea90467b-c750-4512-acad-00eeadbe6a2d 21130-484 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET ORAL 20000706 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 500 mg/1 21130-486_d906429f-15b9-462c-8339-b7de408162bd 21130-486 HUMAN OTC DRUG stool softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20050727 OTC MONOGRAPH NOT FINAL part334 Safeway DOCUSATE SODIUM 100 mg/1 21130-490_87498b9e-42ed-492f-9efc-22c38c3248d8 21130-490 HUMAN OTC DRUG Daytime Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130715 OTC MONOGRAPH FINAL part341 Safeway, Inc. 21130-498_341f6c0d-fe4a-4732-9082-7f4268c89389 21130-498 HUMAN OTC DRUG Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130725 ANDA ANDA078912 Safeway GUAIFENESIN 600 mg/1 21130-500_55e8f5a5-c21d-4e73-a549-64fea1eb7c0d 21130-500 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130725 ANDA ANDA078912 Safeway GUAIFENESIN 600 mg/1 21130-503_9a97ec43-6c72-47c6-965e-201f87c3cefc 21130-503 HUMAN OTC DRUG Aspirin Free Cold Head Congestion Day Time Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED ORAL 20050804 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 21130-504_fdaff153-42dd-4a26-99ec-8ab141d1cfb9 21130-504 HUMAN OTC DRUG hair regrowth treatment for men Minoxidil AEROSOL, FOAM TOPICAL 20120511 ANDA ANDA091344 Safeway MINOXIDIL 5 g/100g 21130-511_71b5caf9-6744-48c9-9c3d-49321e85bb97 21130-511 HUMAN OTC DRUG flu and severe cold and cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20140821 OTC MONOGRAPH FINAL part341 Safeway ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 21130-517_6eb0133c-9cb7-4cee-8e22-3331b81cbcfa 21130-517 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20120809 ANDA ANDA077349 Safeway IBUPROFEN 200 mg/1 21130-519_0933167d-5ef5-4701-bc07-e55b00c99b79 21130-519 HUMAN OTC DRUG Extra Strength Aspirin Free Pain Relief Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 500 mg/1 21130-526_11b3a031-0faa-4b14-bd2c-cd4b6f5c102c 21130-526 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20090606 ANDA ANDA076134 SAFEWAY INC. LORATADINE 10 mg/1 21130-527_d5ec9af0-b2a0-47cd-a418-cfc00df2afd8 21130-527 HUMAN OTC DRUG Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Safeway Inc. LORATADINE 10 mg/1 21130-529_253b65c7-12df-4e51-bf73-242f59418887 21130-529 HUMAN OTC DRUG Multi-Symptom Cold Relief Acetaminophen, Chlorpehniramine HCl, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 Safeway 21130-532_8035533d-49fb-4b39-97a2-b637d2db4625 21130-532 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070718 ANDA ANDA076779 Safeway NICOTINE 4 mg/1 21130-533_b79a2a15-17cb-402c-a007-883a2483f59e 21130-533 HUMAN OTC DRUG Immediate-Release Mucus Relief DM Dextromethorphan HBr and Guiafenesin TABLET, FILM COATED ORAL 20051231 OTC MONOGRAPH FINAL part341 Safeway DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 21130-541_437da8bc-b6bd-46ca-bc72-728ecfc6f79e 21130-541 HUMAN OTC DRUG Anti Itch Hydrocortisone CREAM TOPICAL 20050824 OTC MONOGRAPH NOT FINAL part348 Safeway HYDROCORTISONE 1 g/100g 21130-542_b5fe109e-9b99-47b4-aab6-d625c847fe76 21130-542 HUMAN OTC DRUG Mucus Relief PE Guaifenesin and Phenylephrine HCl TABLET, FILM COATED ORAL 20060415 OTC MONOGRAPH FINAL part341 Safeway GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 21130-550_109ba9c1-c93c-438f-9dcd-91e224422c51 21130-550 HUMAN OTC DRUG migraine relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20140728 ANDA ANDA075794 Safeway ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 21130-556_628e89c8-99ea-4fc3-bcaa-528172d713ab 21130-556 HUMAN OTC DRUG Extra Strength Pain Reliever PM Acetaminophen and Diphenhydramine HCl CAPSULE ORAL 20071217 OTC MONOGRAPH FINAL part341 Safeway ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 21130-557_dfda3c7c-4c57-5917-ab77-7b5372ec14d2 21130-557 HUMAN OTC DRUG Fexofenadine HCl and Pseudoephedrine HCI Fexofenadine HCl and Pseudoephedrine HCI TABLET, EXTENDED RELEASE ORAL 20130205 ANDA ANDA079043 Safeway Inc FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180; 240 mg/1; mg/1 21130-571_9cfdda8d-0b1b-4903-8b39-7dbec2544f3c 21130-571 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110415 ANDA ANDA076447 Safeway FEXOFENADINE HYDROCHLORIDE 180 mg/1 21130-594_51b73a36-4748-452d-aff0-d686de6bb607 21130-594 HUMAN OTC DRUG hair regrowth treatment Minoxidil SOLUTION TOPICAL 20131130 ANDA ANDA075598 Safeway MINOXIDIL 3 g/60mL 21130-600_af0f0714-abff-40a3-9643-63d43641ab41 21130-600 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET ORAL 20080212 OTC MONOGRAPH NOT FINAL part356 Safeway ASPIRIN 81 mg/1 21130-602_6765887e-b727-4e29-baef-8265595bc30f 21130-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20021112 OTC MONOGRAPH NOT FINAL part334 Safeway Inc MAGNESIUM SULFATE 1 g/g 21130-604_6fca6fbd-97ff-43f0-8ad1-938c9fdeff30 21130-604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19970814 ANDA ANDA072096 Safeway IBUPROFEN 200 mg/1 21130-609_3f52fee8-8928-4362-84a1-acc4d9708e0c 21130-609 HUMAN OTC DRUG Night Time Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID ORAL 19940719 OTC MONOGRAPH FINAL part341 Safeway ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 500; 15; 6.25; 30 mg/15mL; mg/15mL; mg/15mL; mg/15mL 21130-610_31e65e9d-35da-4899-91bf-e95e2bd2a8ec 21130-610 HUMAN OTC DRUG ANTIDANDRUFF MEDICATED SELENIUM SULFIDE SHAMPOO TOPICAL 20100805 OTC MONOGRAPH FINAL part358 SAFEWAY INC SELENIUM SULFIDE 1 mL/100mL 21130-612_bcc2b7fa-dae3-4a14-a8a6-3b56f0c69e2d 21130-612 HUMAN OTC DRUG Allergy Relief Loratadine TABLET ORAL 20130729 ANDA ANDA076301 Safeway LORATADINE 10 mg/1 21130-617_57d116c0-0b01-474e-981c-da18b868d0a4 21130-617 HUMAN OTC DRUG SAFEWAY MEDICATED DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20120604 OTC MONOGRAPH FINAL part358H SAFEWAY INC. SELENIUM SULFIDE 1 mL/100mL 21130-619_88cb3c62-7d70-439b-abcd-912c3eadbe75 21130-619 HUMAN OTC DRUG SAFEWAY CARE MEDICATED DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20140225 OTC MONOGRAPH FINAL part358H SAFEWAY INC SELENIUM SULFIDE 10 mg/mL 21130-620_a4a72e34-da4e-4ac9-9a86-20fc3092b183 21130-620 HUMAN OTC DRUG SAFEWAY SELENIUM SULFIDE LIQUID TOPICAL 20130620 OTC MONOGRAPH FINAL part358H SAFEWAY INC. SELENIUM SULFIDE 10 mg/mL 21130-622_c147dd3d-cfcb-4878-9ead-597d3ec9ef69 21130-622 HUMAN OTC DRUG Itch Relief extra strength Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20081120 OTC MONOGRAPH NOT FINAL part348 Safeway DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 21130-647_219fd6f8-e37e-4c58-9c27-73347dc1f504 21130-647 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 19970730 ANDA ANDA072096 Safeway IBUPROFEN 200 mg/1 21130-660_7b773fe3-7715-45d3-9571-b813073cd741 21130-660 HUMAN OTC DRUG childrens ibuprofen Ibuprofen SUSPENSION ORAL 20020502 ANDA ANDA074937 Safeway IBUPROFEN 100 mg/5mL 21130-664_c6446f86-864b-48fc-a9f4-357a37c1311b 21130-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19980315 OTC MONOGRAPH NOT FINAL part356 Safeway, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 21130-667_bba17a67-8aeb-472a-bc95-f73ea4e6b6ec 21130-667 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20030206 OTC MONOGRAPH NOT FINAL part334 Safeway MAGNESIUM CITRATE 1.745 g/29.6mL 21130-678_f1d800dd-ad3a-47d1-b20f-a5c784af7dfe 21130-678 HUMAN OTC DRUG hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20121229 OTC MONOGRAPH FINAL part346 Safeway MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 21130-679_6671fd7e-015f-4ef4-92c5-f5b05cacbdf2 21130-679 HUMAN OTC DRUG triple antibiotic Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20050824 OTC MONOGRAPH FINAL part333B Safeway BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 21130-692_1f26ebf6-f48f-4301-a5d7-d4fea14eda71 21130-692 HUMAN OTC DRUG Cool Heat Menthol, Methyl salicylate CREAM TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part348 Safeway MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g 21130-724_2c559299-a50b-46ce-818c-cf99d9edb61c 21130-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Safeway Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 21130-742_8ac18494-2890-4667-8a56-df9a08467b38 21130-742 HUMAN OTC DRUG Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20101213 NDA NDA021920 Safeway NAPROXEN SODIUM 220 mg/1 21130-760_0a02ebb4-0d21-4159-b143-54662c512451 21130-760 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Safeway Inc. ACETAMINOPHEN 650 mg/1 21130-765_508129fa-b6a4-4a28-8a49-a8e76286e39e 21130-765 HUMAN OTC DRUG Sinus and Allergy PE Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20050609 OTC MONOGRAPH FINAL part341 Safeway CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 21130-766_1f58b7fe-648e-4fbc-912d-3e4f34c8ba43 21130-766 HUMAN OTC DRUG Sinus Headache PE Acetaminophen and Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 21130-768_a12de353-a005-41a9-971d-c816b0855115 21130-768 HUMAN OTC DRUG Daytime Cold and Pain Relief Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED ORAL 20050804 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 21130-778_173d9cd4-66db-4f73-b1f7-b5dbd9e44363 21130-778 HUMAN OTC DRUG Less Drowsy Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 Safeway MECLIZINE HYDROCHLORIDE 25 mg/1 21130-779_d381a3d7-82f3-4dbd-9c14-c1cd68bfefbb 21130-779 HUMAN OTC DRUG Pain Relief PM Extra Strength Aspirin Free Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130315 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 21130-784_890d2424-1095-1c02-ed18-54e4a86d7049 21130-784 HUMAN OTC DRUG Allergy Relief Fexofenadine hydrochloride TABLET ORAL 20130422 ANDA ANDA076502 Safeway Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 21130-787_b55db1a4-f78b-48aa-8a9d-fce56def3d10 21130-787 HUMAN OTC DRUG Childrens Non-Drowsy 24-Hour Allergy Relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Safeway Inc. LORATADINE 5 mg/5mL 21130-798_2ab5cd22-e65b-41b2-b262-562df5ac46a0 21130-798 HUMAN OTC DRUG Hair Regrowth Treatment Extra Strength for Men Minoxidil SOLUTION TOPICAL 20091210 ANDA ANDA075598 Safeway MINOXIDIL 3 g/60mL 21130-826_886e75dc-00ea-491f-89ed-1c9e5cc13e6a 21130-826 HUMAN OTC DRUG SAFEWAY ACNE TREATMENT BENZOYL PEROXIDE CREAM TOPICAL 20120606 OTC MONOGRAPH NOT FINAL part333D SAFEWAY INC. BENZOYL PEROXIDE 10 g/100g 21130-831_50578e66-11a2-493f-a5fd-f38d9b69849a 21130-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 20021113 OTC MONOGRAPH NOT FINAL part334 Safeway MINERAL OIL 999 mg/mL 21130-854_2d072bec-a5ce-4456-ab04-b260b9a0ce5a 21130-854 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20080122 ANDA ANDA078546 Safeway NICOTINE 4 mg/1 21130-857_65b51efc-15ec-4389-8993-97ecb7e9dfc5 21130-857 HUMAN OTC DRUG Antifungal Clotrimazole CREAM TOPICAL 20081120 OTC MONOGRAPH FINAL part333C Safeway CLOTRIMAZOLE 1 g/100g 21130-873_67a3419c-a599-428e-bf0e-a63f9e7cc3b8 21130-873 HUMAN OTC DRUG nicotine Nicotine Polacrilex LOZENGE ORAL 20060413 ANDA ANDA077007 Safeway NICOTINE 4 mg/1 21130-882_e9fc1763-9568-41cd-a777-6c123d0d156a 21130-882 HUMAN OTC DRUG Infants Gas Relief Simethicone EMULSION ORAL 20020822 OTC MONOGRAPH FINAL part332 Safeway DIMETHICONE 20 mg/.3mL 21130-897_de436e79-e5b8-471c-ab2c-d92669e4b140 21130-897 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990118 ANDA ANDA074937 Safeway IBUPROFEN 100 mg/5mL 21130-915_32b2f0b1-8f1b-4240-b1f6-b6105d437a16 21130-915 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080225 NDA NDA022032 Safeway OMEPRAZOLE 20 mg/1 21130-921_a35182bd-171b-45fe-9faa-5b85bc9651a3 21130-921 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 Safeway IBUPROFEN 200 mg/1 21130-946_e43c0a22-c624-41c3-b138-a43aba11f3d3 21130-946 HUMAN OTC DRUG aspirin free Acetaminophen LIQUID ORAL 20110810 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 160 mg/5mL 21130-950_b14e06ca-de7d-4248-b716-a8142d2f0c17 21130-950 HUMAN OTC DRUG acid reducer 150 Ranitidine TABLET, FILM COATED ORAL 20110929 ANDA ANDA091429 Safeway RANITIDINE HYDROCHLORIDE 150 mg/1 21130-955_fdbcdac8-bda6-45ae-90a7-2a310bcd2253 21130-955 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20051222 OTC MONOGRAPH FINAL part341 Safeway GUAIFENESIN 400 mg/1 21130-958_fe38bbe7-a84e-4a30-b32c-4e439dcd4a52 21130-958 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130625 ANDA ANDA091135 Safeway DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 21130-964_9bc3133a-7e76-43d6-b669-0e13e570e160 21130-964 HUMAN OTC DRUG flu and severe cold and cough nighttime Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20101111 OTC MONOGRAPH FINAL part341 Safeway ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 21130-974_9c7923b8-d7b6-4ded-a042-94ba067451ce 21130-974 HUMAN OTC DRUG Childrens Allergy Relief cetirizine hydrochloride LIQUID ORAL 20140515 ANDA ANDA090254 Safeway CETIRIZINE HYDROCHLORIDE 5 mg/5mL 21220-119_ee7c86b5-0a70-45bb-a68e-eaa2da49a4b3 21220-119 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19720601 UNAPPROVED MEDICAL GAS General Air Service & Supply Co OXYGEN 995 mL/L 21220-120_72822f4e-6b0b-437c-94ca-ce96e4606687 21220-120 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19740801 UNAPPROVED MEDICAL GAS General Air Service & Supply Co NITROGEN 999 mL/L 21220-121_87328bf3-9723-4056-a087-f35889f51542 21220-121 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19580101 UNAPPROVED MEDICAL GAS General Air Service & Supply Co HELIUM 990 mL/L 21220-122_7010c496-972c-49c8-bbb9-b54248a53658 21220-122 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19761101 UNAPPROVED MEDICAL GAS General Air Service & Supply Co NITROUS OXIDE 995 mL/L 21220-123_9c3ee274-2719-4fc2-97ee-212943c14e5a 21220-123 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19720601 UNAPPROVED MEDICAL GAS General Air Service & Supply Co CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 21220-124_b857067f-30e2-4b5d-86b2-7729ec75eb27 21220-124 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19740801 UNAPPROVED MEDICAL GAS General Air Service & Supply Co AIR 990 mL/L 21220-125_5fd44dc8-d31f-4da0-b534-e38b0e17d2f5 21220-125 HUMAN PRESCRIPTION DRUG Carbon Dioxide Air Mixture Carbon Dioxide Air Mixture GAS RESPIRATORY (INHALATION) 19750101 UNAPPROVED MEDICAL GAS General Air Service & Supply Co AIR; CARBON DIOXIDE 950; 50 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 21220-127_36e702f1-4f5d-4286-a650-3d0ccbe2f16d 21220-127 HUMAN PRESCRIPTION DRUG Helium/Oxygen Mixture 80/20 Helium/Oxygen Mixture 80/20 GAS RESPIRATORY (INHALATION) 19750101 UNAPPROVED MEDICAL GAS General Air Service & Supply Co HELIUM; OXYGEN 800; 200 mL/L; mL/L 21220-128_5f843e2c-2800-4d2f-811b-9b3858be7c2b 21220-128 HUMAN PRESCRIPTION DRUG Helium/Oxygen Mixture 70/30 Helium/Oxygen Mixture 70/30 GAS RESPIRATORY (INHALATION) 19750101 UNAPPROVED MEDICAL GAS General Air Service & Supply Co HELIUM; OXYGEN 700; 300 mL/L; mL/L 21220-129_0a9fb947-5870-490f-b6b9-be3c36088b14 21220-129 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mixture Carbon Dioxide Oxygen Mixture GAS RESPIRATORY (INHALATION) 19750101 UNAPPROVED MEDICAL GAS General Air Service & Supply Co CARBON DIOXIDE; OXYGEN 200; 800 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 21221-001_13e9390b-d950-4946-af18-e1193bb2692c 21221-001 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20060303 UNAPPROVED MEDICAL GAS General Cryogenic Technologies LLC NITROGEN 990 mL/L 21221-002_bf3fde03-f728-4fce-9d63-1e769f463c84 21221-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060303 UNAPPROVED MEDICAL GAS General Cryogenic Technologies LLC OXYGEN 995 mL/L 21532-1410_63300bac-56fe-4778-b568-af76a583ba5b 21532-1410 HUMAN OTC DRUG SaniKlean E3 Hand Sanitizer Alcohol LIQUID TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333A Bunzl Processor Distribution LLC ALCOHOL 70 mL/100mL 21532-5572_18802008-cc21-46be-8563-23b9474eafb5 21532-5572 HUMAN OTC DRUG SEPTISURGE CHLOROXYLENOL SOAP TOPICAL 20140214 OTC MONOGRAPH NOT FINAL part333E BUNZL DISTRIBUTION CHLOROXYLENOL 2.5 g/1000mL 21624-001_26ec7396-f0c2-4c89-9888-a2297212c5f2 21624-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19500101 NDA NDA205889 Island Supply Welding Co Inc OXYGEN 995 mL/L 21695-002_217e52b5-3a7b-4bbe-af3c-b18de7d426c3 21695-002 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Rebel Distributors Corp. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] 21695-003_217e52b5-3a7b-4bbe-af3c-b18de7d426c3 21695-003 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Rebel Distributors Corp. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] 21695-004_217e52b5-3a7b-4bbe-af3c-b18de7d426c3 21695-004 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Rebel Distributors Corp. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] 21695-005_217e52b5-3a7b-4bbe-af3c-b18de7d426c3 21695-005 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Rebel Distributors Corp. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] 21695-006_76c7e13d-37a0-4131-a1f1-fd5af0f60d3e 21695-006 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20091015 ANDA ANDA078858 Rebel Distributors Corp LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-007_457a2359-e7bc-4d23-a064-439989aa208d 21695-007 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20070101 OTC MONOGRAPH NOT FINAL part343 Rebel Distributors Corp ACETAMINOPHEN 325 mg/1 21695-008_457a2359-e7bc-4d23-a064-439989aa208d 21695-008 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20070101 OTC MONOGRAPH NOT FINAL part343 Rebel Distributors Corp ACETAMINOPHEN 500 mg/1 21695-009_a2db7131-bf31-47bf-bf61-594f919af1f2 21695-009 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir CAPSULE ORAL 19981030 ANDA ANDA074975 Rebel Distributors Corp ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 21695-010_a2db7131-bf31-47bf-bf61-594f919af1f2 21695-010 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 19981030 ANDA ANDA074980 Rebel Distributors Corp ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 21695-011_a2db7131-bf31-47bf-bf61-594f919af1f2 21695-011 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 19981030 NDA AUTHORIZED GENERIC NDA074980 Rebel Distributors Corp ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 21695-012_b9776e0b-8fc5-4d16-a5e2-482b806abb16 21695-012 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 Rebel Distributors Corp. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 21695-013_b9776e0b-8fc5-4d16-a5e2-482b806abb16 21695-013 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065405 Rebel Distributors Corp. AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 21695-014_14878615-b39c-477e-b33d-dd9753c7a3cf 21695-014 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20040701 ANDA ANDA072824 Rebel Distributors Corp. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 21695-015_14878615-b39c-477e-b33d-dd9753c7a3cf 21695-015 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20040701 ANDA ANDA072825 Rebel Distributors Corp. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 21695-016_76c7e13d-37a0-4131-a1f1-fd5af0f60d3e 21695-016 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20091015 ANDA ANDA078858 Rebel Distributors Corp LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-017_725b405d-a6e5-4ad6-820f-4fdebcbfe9fe 21695-017 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Rebel Distributors Corp. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 21695-018_725b405d-a6e5-4ad6-820f-4fdebcbfe9fe 21695-018 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Rebel Distributors Corp. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 21695-019_5649e22a-aec5-4bb8-83d7-35623185bd34 21695-019 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090901 ANDA ANDA079095 Rebel Distributors Corp. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 21695-020_5649e22a-aec5-4bb8-83d7-35623185bd34 21695-020 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090901 ANDA ANDA079095 Rebel Distributors Corp. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 21695-022_c4ec3cc2-8574-4134-970e-26a82c5dbc0e 21695-022 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Rebel Distributors Corp. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-023_c4ec3cc2-8574-4134-970e-26a82c5dbc0e 21695-023 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Rebel Distributors Corp. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-024_f82ee9e3-5119-4be0-883c-5831386baef6 21695-024 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Rebel Distributors Corp LEVOFLOXACIN 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 21695-025_d42b0f1d-8930-4b69-9624-8d6c500caba8 21695-025 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20090801 ANDA ANDA077789 Rebel Distributors Corp CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] 21695-027_f82ee9e3-5119-4be0-883c-5831386baef6 21695-027 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Rebel Distributors Corp LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 21695-028_a2e793ab-7e78-463d-9bad-312af00f2e88 21695-028 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Rebel Distributors Corp. TADALAFIL 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 21695-029_a2e793ab-7e78-463d-9bad-312af00f2e88 21695-029 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Rebel Distributors Corp. TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 21695-030_a0fdcf12-0e79-4814-910f-5f4cc7463c13 21695-030 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20070327 ANDA ANDA078216 Rebel Distributors Corp. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-031_a0fdcf12-0e79-4814-910f-5f4cc7463c13 21695-031 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20070327 ANDA ANDA078216 Rebel Distributors Corp. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-032_a0fdcf12-0e79-4814-910f-5f4cc7463c13 21695-032 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20070327 ANDA ANDA078216 Rebel Distributors Corp. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-033_da1d371a-5541-468f-985b-6e4e214b7c16 21695-033 HUMAN PRESCRIPTION DRUG clindamycin hydrochloride clindamycin hydrochloride CAPSULE ORAL 20010202 ANDA ANDA065061 Rebel Distributors Corp CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 21695-034_da1d371a-5541-468f-985b-6e4e214b7c16 21695-034 HUMAN PRESCRIPTION DRUG clindamycin hydrochloride clindamycin hydrochloride CAPSULE ORAL 20010202 ANDA ANDA065061 Rebel Distributors Corp CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 21695-035_8e1058cf-1bd4-4c81-81a5-3a1754caca3f 21695-035 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 19950601 OTC MONOGRAPH FINAL part333C Rebel Distributors Corp CLOTRIMAZOLE 1 g/100g 21695-036_caf7ed82-954c-498b-82bc-39fd903ab030 21695-036 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20060419 ANDA ANDA077563 Rebel Distributors CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 21695-037_3290187a-7eb6-4067-ac9e-fc8dfc722e0e 21695-037 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100218 ANDA ANDA078218 Rebel Distributors CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 21695-038_6b7fb6b7-2f58-4cb6-b48f-e9b4cf292365 21695-038 HUMAN PRESCRIPTION DRUG diclofenac sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Rebel Distributors Corp DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-039_6b7fb6b7-2f58-4cb6-b48f-e9b4cf292365 21695-039 HUMAN PRESCRIPTION DRUG diclofenac sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Rebel Distributors Corp DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-040_51b4f63e-03fd-40f4-804b-39fd80842fd6 21695-040 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Extended-Release Diclofenac Sodium TABLET, EXTENDED RELEASE ORAL 20020107 ANDA ANDA075910 Rebel Distributors Corp. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-041_f82ee9e3-5119-4be0-883c-5831386baef6 21695-041 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Rebel Distributors Corp LEVOFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 21695-043_487b4138-f7db-480f-96d2-8010fd5c0c06 21695-043 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20020709 ANDA ANDA075616 Rebel Distributors Corp NIZATIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 21695-044_d583b8b9-e5c7-45d6-8fc1-d51f51a16181 21695-044 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19841107 ANDA ANDA062396 Rebel Distributors Corp DOXYCYCLINE HYCLATE 100 mg/1 21695-045_8a2302ca-5c25-4d2d-9ffe-320080934aab 21695-045 HUMAN PRESCRIPTION DRUG Effexor XR Extended-Release venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-046_8a2302ca-5c25-4d2d-9ffe-320080934aab 21695-046 HUMAN PRESCRIPTION DRUG Effexor XR Extended-Release venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-047_8a2302ca-5c25-4d2d-9ffe-320080934aab 21695-047 HUMAN PRESCRIPTION DRUG Effexor XR Extended-Release venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-048_96c89e90-4db0-49df-bf0e-62991cc1dadb 21695-048 HUMAN OTC DRUG ORGAN-I NR guaifenesin TABLET ORAL 20020701 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp GUAIFENESIN 200 mg/1 21695-049_db60911a-2bb1-4e8c-baf0-7cf281bf5778 21695-049 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE, GELATIN COATED ORAL 19990916 ANDA ANDA075126 Rebel Distributors Corp ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-050_d7cf7ed9-d7b4-4dcc-8a25-a9177c54f847 21695-050 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980311 ANDA ANDA075074 Rebel Distributors Corp ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-052_a1575590-4bdd-4f66-91fb-337e5f681747 21695-052 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Rebel Distributors Corp FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-053_a1575590-4bdd-4f66-91fb-337e5f681747 21695-053 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Rebel Distributors Corp FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-054_e6c2595a-1470-4cf4-93ea-0fedf917cf85 21695-054 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine CAPSULE ORAL 20050720 ANDA ANDA076990 Rebel Distributors Corp FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-055_6f3e6391-e711-42bd-9d95-ce15d7a44ed5 21695-055 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20090924 ANDA ANDA075360 Rebel Distributors Corp. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-056_6f3e6391-e711-42bd-9d95-ce15d7a44ed5 21695-056 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20060829 ANDA ANDA075360 Rebel Distributors Corp. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-058_95ceac2d-ce96-4d9d-9fe6-893940f1decb 21695-058 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET, FILM COATED ORAL 20060824 ANDA ANDA077525 Rebel Distributors Corp. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-059_95ceac2d-ce96-4d9d-9fe6-893940f1decb 21695-059 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET, FILM COATED ORAL 20060824 ANDA ANDA077525 Rebel Distributors Corp. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-060_a3aa96bb-2cc1-4316-b94c-61593e927505 21695-060 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Rebel Distributors Corp ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 21695-061_a3aa96bb-2cc1-4316-b94c-61593e927505 21695-061 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Rebel Distributors Corp ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 21695-062_a3aa96bb-2cc1-4316-b94c-61593e927505 21695-062 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Rebel Distributors Corp ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 21695-063_a3aa96bb-2cc1-4316-b94c-61593e927505 21695-063 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Rebel Distributors Corp ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 21695-065_7b4858fc-fea6-4e4c-886e-a2febe1ed2c3 21695-065 HUMAN OTC DRUG Ibuprofen (NSAID) Pain Releiver/ Fever Reducer Ibuprofen (NSAID) TABLET ORAL 20091216 ANDA ANDA071333 Rebel Distributors Corp IBUPROFEN 200 mg/1 21695-066_79505457-733c-4253-ac74-fa864b1a9e55 21695-066 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Rebel Distributors Corp IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-067_79505457-733c-4253-ac74-fa864b1a9e55 21695-067 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Rebel Distributors Corp IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-068_79505457-733c-4253-ac74-fa864b1a9e55 21695-068 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Rebel Distributors Corp IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-069_7997e6da-7e98-4520-9d1b-0b8341bac64a 21695-069 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20090601 NDA NDA022304 Rebel Distributors Corp TAPENTADOL HYDROCHLORIDE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 21695-070_d1329893-a8bc-4f31-a31b-76690d111035 21695-070 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET ORAL 20000424 NDA NDA021035 Rebel Distributors Corp LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-071_76c7e13d-37a0-4131-a1f1-fd5af0f60d3e 21695-071 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20091015 ANDA ANDA078858 Rebel Distributors Corp LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-072_2e8fb017-8754-421a-a76a-c41b8f48070b 21695-072 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 Rebel Distributors Corp RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 21695-075_fabe0c3a-db41-4e48-ab33-8e9894fa3c18 21695-075 HUMAN PRESCRIPTION DRUG LIDODERM Lidocaine PATCH CUTANEOUS 20100201 NDA NDA020612 Rebel Distributors Corp. LIDOCAINE 700 mg/12h Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 21695-076_145dbdd2-123e-4b06-ac03-4e08619b50f6 21695-076 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET 20061220 ANDA ANDA077927 Rebel Distributors Corp. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-077_145dbdd2-123e-4b06-ac03-4e08619b50f6 21695-077 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20061220 ANDA ANDA077927 Rebel Distributors Corp. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-078_2e5d447c-a50c-4905-b56f-32fe86824dd9 21695-078 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Rebel Distributors Corp. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 21695-079_2e5d447c-a50c-4905-b56f-32fe86824dd9 21695-079 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19760818 ANDA ANDA085123 Rebel Distributors Corp. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 21695-080_98d480de-4089-477f-a049-0e09c59c5332 21695-080 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 Rebel Distributors Corp. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-081_18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8 21695-081 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Rebel Distributors Corp. MIRTAZAPINE 15 mg/1 21695-082_18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8 21695-082 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Rebel Distributors Corp. MIRTAZAPINE 30 mg/1 21695-083_18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8 21695-083 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Rebel Distributors Corp. MIRTAZAPINE 45 mg/1 21695-084_a04bcc67-1f1a-4669-bb69-77738a939944 21695-084 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Rebel Distributors Corp. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-085_a04bcc67-1f1a-4669-bb69-77738a939944 21695-085 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Rebel Distributors Corp. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-086_a04bcc67-1f1a-4669-bb69-77738a939944 21695-086 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Rebel Distributors Corp. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-087_2e8fb017-8754-421a-a76a-c41b8f48070b 21695-087 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 Rebel Distributors Corp RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 21695-088_456815fd-1e98-43fa-8f20-47cc3b8a15bd 21695-088 HUMAN OTC DRUG Naproxen Pain Relief Naproxen Sodium TABLET ORAL 19980312 ANDA ANDA074661 Rebel Distributors Corp NAPROXEN SODIUM 220 mg/1 21695-089_2e8fb017-8754-421a-a76a-c41b8f48070b 21695-089 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 Rebel Distributors Corp RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 21695-090_0c01cb34-0d6b-4248-afde-82d4d934dabd 21695-090 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Rebel Distributors Corp NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-091_ea79f802-e9ac-480b-91e6-1e3900b11803 21695-091 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20110708 NDA NDA021153 Rebel Distributors Corp ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 21695-092_ea79f802-e9ac-480b-91e6-1e3900b11803 21695-092 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20110708 NDA NDA021153 Rebel Distributors Corp ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 21695-093_03601ccc-4a9a-4cb9-9028-281bbed42182 21695-093 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920330 ANDA ANDA073553 Rebel Distributors Corp NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 21695-094_03601ccc-4a9a-4cb9-9028-281bbed42182 21695-094 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920330 ANDA ANDA073554 Rebel Distributors Corp NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 21695-095_2e8fb017-8754-421a-a76a-c41b8f48070b 21695-095 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 Rebel Distributors Corp RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 21695-096_2e8fb017-8754-421a-a76a-c41b8f48070b 21695-096 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 Rebel Distributors Corp RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 21695-097_b6939539-2d45-4ea0-9744-72d7691e331f 21695-097 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20030903 ANDA ANDA075410 Rebel Distributors Corp. OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 21695-098_b6939539-2d45-4ea0-9744-72d7691e331f 21695-098 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20021104 ANDA ANDA075410 Rebel Distributors Corp. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 21695-099_34769dda-f555-460e-9064-98ab205393c5 21695-099 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Rebel Distributors Corp ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 21695-100_e77d2b9e-84df-4733-b654-16e93618efce 21695-100 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20100908 ANDA ANDA075849 Rebel Distributors Corp OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-101_0d4fb45b-e45b-4519-96a3-a8a106450f87 21695-101 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Rebel Distributors Corp PAROXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-102_0d4fb45b-e45b-4519-96a3-a8a106450f87 21695-102 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077854 Rebel Distributors Corp PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-103_0d4fb45b-e45b-4519-96a3-a8a106450f87 21695-103 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Rebel Distributors Corp PAROXETINE HYDROCHLORIDE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-104_0d4fb45b-e45b-4519-96a3-a8a106450f87 21695-104 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Rebel Distributors Corp PAROXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-105_23bb4390-7825-4b2c-9dd9-48d2ee90bc6c 21695-105 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080501 NDA NDA020859 Rebel Distributors Corp. ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 21695-106_d15c8f36-4dcc-4b28-b03c-4e81b2f9ad2e 21695-106 HUMAN PRESCRIPTION DRUG Prevacid SoluTab lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20020830 NDA NDA021428 Rebel Distributors Corp LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 21695-107_7332e0ea-fbd0-43fb-8d1e-f7068504c61d 21695-107 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 NDA NDA078525 Rebel Distributors Corp LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 21695-108_cfeacb5c-8b1b-48f6-9acf-00044a8179b4 21695-108 HUMAN PRESCRIPTION DRUG Protonix pantoprazoel sodium TABLET, DELAYED RELEASE ORAL 20010828 NDA NDA020987 Rebel Distributors Corp PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 21695-109_dcee67ac-e58c-4050-ad16-f8253a17036b 21695-109 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091217 ANDA ANDA077824 Rebel Distributors RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 21695-110_dcee67ac-e58c-4050-ad16-f8253a17036b 21695-110 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091217 ANDA ANDA077824 Rebel Distributors RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 21695-111_fce17e4f-926c-4b50-8fd6-f415d1a13570 21695-111 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate sodium TABLET ORAL 19901015 ANDA ANDA081099 Rebel Distributors Corp METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 21695-112_77215d87-ad22-4169-bd5f-a453f10b21ef 21695-112 HUMAN PRESCRIPTION DRUG Androgel testosterone GEL TRANSDERMAL 20030605 NDA NDA021015 Rebel Distributors Corp. TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 21695-113_fca1c3cd-45f3-45cc-bb1d-656c65e91c8a 21695-113 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Rebel Distributors Corp RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 21695-114_49860a2f-92f2-4da8-b78f-0efc005d725a 21695-114 HUMAN PRESCRIPTION DRUG Clomiphene Citrate Clomiphene Citrate TABLET ORAL 19990830 ANDA ANDA075528 Rebel Distributors Corp CLOMIPHENE CITRATE 50 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 21695-115_fca1c3cd-45f3-45cc-bb1d-656c65e91c8a 21695-115 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Rebel Distributors Corp RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 21695-117_3dc79540-2f24-4920-99cd-ef6482f68eb2 21695-117 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Rebel Distributors Corp QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 21695-118_3dc79540-2f24-4920-99cd-ef6482f68eb2 21695-118 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Rebel Distributors Corp QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 21695-119_3dc79540-2f24-4920-99cd-ef6482f68eb2 21695-119 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Rebel Distributors Corp QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 21695-120_3dc79540-2f24-4920-99cd-ef6482f68eb2 21695-120 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Rebel Distributors Corp QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 21695-121_e53a8376-7107-473a-aa89-2cebee415864 21695-121 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate TABLET ORAL 20050325 ANDA ANDA077152 Rebel Distributors Corp TERBUTALINE SULFATE 5 mg/1 21695-122_e53a8376-7107-473a-aa89-2cebee415864 21695-122 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate TABLET ORAL 20050325 ANDA ANDA077152 Rebel Distributors Corp TERBUTALINE SULFATE 2.5 mg/1 21695-123_cb47d76e-a7e3-4bac-8074-8d7e95c6a6eb 21695-123 HUMAN PRESCRIPTION DRUG Skelaxin Metaxalone TABLET ORAL 19620813 NDA NDA013217 Rebel Distributors Corp METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 21695-124_33434f66-1d36-4506-9b3d-9755c978d9b2 21695-124 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19710401 ANDA ANDA061454 Rebel Distributors Corp DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 21695-125_78b559bd-44e8-45d2-96dc-5827b5f2caec 21695-125 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100225 ANDA ANDA076899 Rebel Distributors Corp. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 21695-126_03fa46db-3676-4e0b-876d-5d226036b73e 21695-126 HUMAN PRESCRIPTION DRUG TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET ORAL 20070206 ANDA ANDA076347 Rebel Distributors TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 21695-127_03fa46db-3676-4e0b-876d-5d226036b73e 21695-127 HUMAN PRESCRIPTION DRUG TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET ORAL 20070206 ANDA ANDA076347 Rebel Distributors TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 21695-128_202b1a2a-11dc-4c3d-aa53-27512a98a042 21695-128 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 Rebel Distributors Corp TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-129_202b1a2a-11dc-4c3d-aa53-27512a98a042 21695-129 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 Rebel Distributors Corp TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-130_202b1a2a-11dc-4c3d-aa53-27512a98a042 21695-130 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 Rebel Distributors Corp TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-131_8e80f9d8-2577-4fd9-a455-e6c6dc244c3a 21695-131 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Rebel Distributors Corp FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 21695-132_ba1be142-668f-41de-a545-852e1e8ff852 21695-132 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20091123 ANDA ANDA076003 Rebel Distributors Corp. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 21695-133_370453cb-7636-43f2-93f0-e8714884fab4 21695-133 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone TABLET ORAL 19871211 ANDA ANDA071523 Rebel Distributors Corp. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 21695-134_370453cb-7636-43f2-93f0-e8714884fab4 21695-134 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone TABLET ORAL 19871211 ANDA ANDA071524 Rebel Distributors Corp. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 21695-135_370453cb-7636-43f2-93f0-e8714884fab4 21695-135 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone TABLET ORAL 19880309 ANDA ANDA071525 Rebel Distributors Corp. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 21695-136_76c7e13d-37a0-4131-a1f1-fd5af0f60d3e 21695-136 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20091015 ANDA ANDA078858 Rebel Distributors Corp LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-137_fdd1fa5e-9dbf-4951-a8e9-33d06e05bdba 21695-137 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20091223 NDA NDA021515 Rebel Distributors Corp BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 21695-138_fdd1fa5e-9dbf-4951-a8e9-33d06e05bdba 21695-138 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20091223 NDA NDA021515 Rebel Distributors Corp BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 21695-139_aa9bfa49-c3b3-419d-a283-5ea0fd6fc3a0 21695-139 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, and Caffeine butalbital, aspirin, and caffeine CAPSULE ORAL 20030918 ANDA ANDA086231 Rebel Distributors Corp ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 21695-140_a3c9ea17-3793-494a-8b32-44e48f9f4503 21695-140 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 Rebel Distributors Corp OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 21695-141_2d821387-4b4f-4fe3-825e-750f49755baf 21695-141 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20100407 ANDA ANDA089684 Rebel Distributors Corp PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 21695-142_a3c9ea17-3793-494a-8b32-44e48f9f4503 21695-142 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 Rebel Distributors Corp OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 21695-143_750e7372-022b-454e-86c4-e4b325fb9f42 21695-143 HUMAN PRESCRIPTION DRUG ULTRACET tramadol hydrochloride and acetaminophen TABLET ORAL 20010815 NDA NDA021123 Rebel Distributors Corp ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 21695-144_a3c9ea17-3793-494a-8b32-44e48f9f4503 21695-144 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20010301 NDA NDA020592 Rebel Distributors Corp OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 21695-145_7c38b799-9341-4962-914b-fec751123b29 21695-145 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Rebel Distributors Corp. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-146_7c38b799-9341-4962-914b-fec751123b29 21695-146 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Rebel Distributors Corp. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-147_fd156adc-3174-44da-bff7-eeaef5983f18 21695-147 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 19990715 NDA NDA021073 Rebel Distributors Corp. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 21695-148_fd156adc-3174-44da-bff7-eeaef5983f18 21695-148 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 19990715 NDA NDA021073 Rebel Distributors Corp. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 21695-150_1f35ed70-4947-4d4d-b4c8-71ce520fc445 21695-150 HUMAN PRESCRIPTION DRUG Cefuroxime axetil Cefuroxime axetil TABLET ORAL 20060329 ANDA ANDA065308 Rebel Distributors Corp CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 21695-151_b00570ff-4081-4514-b45b-eb6f753450f5 21695-151 HUMAN PRESCRIPTION DRUG Norvasc amlodipine besylate TABLET ORAL 19920731 NDA NDA019787 Rebel Distributors Corp AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 21695-153_35eb525b-72a5-4ef9-a36a-531e9e6b3560 21695-153 HUMAN PRESCRIPTION DRUG Xopenex levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 19990401 NDA NDA020837 Rebel Distributors Corp LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 21695-154_a169b0c0-600f-4072-8ab7-fafc386eab80 21695-154 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate TABLET, FILM COATED ORAL 20031217 NDA NDA020132 Rebel Distributors Corp SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 21695-155_c9c9efaf-983f-4f72-9099-0957fee5396c 21695-155 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060317 ANDA ANDA077634 Rebel Distributors Corp ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-156_dc47903e-8d29-43eb-a647-1e8d28232bb9 21695-156 HUMAN PRESCRIPTION DRUG Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate OINTMENT OPHTHALMIC 19950130 ANDA ANDA064028 Rebel Distributors Corp. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 21695-157_4d60822d-1c9b-494d-adb3-20fe921d9c58 21695-157 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 20030717 NDA NDA020895 Rebel Distributors Corp SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 21695-158_4d60822d-1c9b-494d-adb3-20fe921d9c58 21695-158 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 20100211 NDA NDA020895 Rebel Distributors Corp SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 21695-159_a73cf8ee-f99b-4972-8939-0d394a527134 21695-159 HUMAN PRESCRIPTION DRUG PAXIL CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020409 NDA NDA020936 Rebel Distributors Corp PAROXETINE HYDROCHLORIDE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-160_a73cf8ee-f99b-4972-8939-0d394a527134 21695-160 HUMAN PRESCRIPTION DRUG PAXIL CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020409 NDA NDA020936 Rebel Distributors Corp PAROXETINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-161_17dbfc4c-d62e-4efa-930d-29df7de69fa3 21695-161 HUMAN PRESCRIPTION DRUG Thiothixene Thiothixene CAPSULE ORAL 19870624 ANDA ANDA071529 Rebel Distributors Corp THIOTHIXENE 5 mg/1 Typical Antipsychotic [EPC] 21695-162_56145d1a-1c0c-4c39-951e-45b9f324abcb 21695-162 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Rebel Distributors Corp TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-163_bfbc2cfb-8e96-4cf2-81c7-d63a1b7365c4 21695-163 HUMAN PRESCRIPTION DRUG Depakote Divalproex sodium TABLET, EXTENDED RELEASE ORAL 20100607 NDA NDA021168 Rebel Distributors Corp DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 21695-164_232a00a4-761e-422f-b62a-1a16de631eb6 21695-164 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA077397 Rebel Distributors Corp SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-165_232a00a4-761e-422f-b62a-1a16de631eb6 21695-165 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA077397 Rebel Distributors Corp SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-166_232a00a4-761e-422f-b62a-1a16de631eb6 21695-166 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA077397 Rebel Distributors Corp SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-167_b7758662-dcd2-4a02-933f-8a3de70cf551 21695-167 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20060905 ANDA ANDA040684 Rebel Distributors Corp PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-168_4150414d-ed40-4055-ab75-7e17627ce7c6 21695-168 HUMAN PRESCRIPTION DRUG MEPHYTON phytonadione TABLET ORAL 19550930 NDA NDA010104 Rebel Distributors Corp PHYTONADIONE 5 mg/1 Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 21695-169_74ce605d-b493-4b95-9d59-9253f81f4e20 21695-169 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20041117 NDA NDA021487 Rebel Distributors Corp MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 21695-170_f15b043d-fcfa-4ade-a3da-76700c0c5c2a 21695-170 HUMAN PRESCRIPTION DRUG Prograf Tacrolimus CAPSULE, GELATIN COATED ORAL 19940408 NDA NDA050708 Rebel Distributors Corp ANHYDROUS TACROLIMUS 1 mg/1 21695-171_23d74606-134c-464c-8323-9cf52bb3c5fa 21695-171 HUMAN PRESCRIPTION DRUG CellCept Mycophenolate Mofetil CAPSULE ORAL 19950503 NDA NDA050722 Rebel Distributors Corp MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 21695-172_0eefdd8d-7745-47ae-a204-f35687f3db11 21695-172 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Rebel Distributors Corp. BUSPIRONE HYDROCHLORIDE 15 mg/1 21695-173_d8b0abac-c32c-4bd0-8247-5c6d6a9fd17f 21695-173 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940729 ANDA ANDA064067 Rebel Distributors Corp ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 21695-174_4afee435-ae60-4260-a1df-e52abf7a043d 21695-174 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Rebel Distributors Corp NEFAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 21695-175_4afee435-ae60-4260-a1df-e52abf7a043d 21695-175 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Rebel Distributors Corp NEFAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 21695-176_4afee435-ae60-4260-a1df-e52abf7a043d 21695-176 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Rebel Distributors Corp NEFAZODONE HYDROCHLORIDE 200 mg/1 Serotonin Reuptake Inhibitor [EPC] 21695-177_4afee435-ae60-4260-a1df-e52abf7a043d 21695-177 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Rebel Distributors Corp NEFAZODONE HYDROCHLORIDE 250 mg/1 Serotonin Reuptake Inhibitor [EPC] 21695-178_762daef1-2ad2-444d-958b-f0a69c8ac259 21695-178 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA076939 Rebel Distributors Corp PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 21695-179_762daef1-2ad2-444d-958b-f0a69c8ac259 21695-179 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA076939 Rebel Distributors Corp PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 21695-180_762daef1-2ad2-444d-958b-f0a69c8ac259 21695-180 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA076939 Rebel Distributors Corp PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 21695-181_4a81751e-1c63-4b0d-8f63-bf7c4d155f22 21695-181 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20020702 ANDA ANDA076514 Rebel Distributors Corp MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 21695-182_338f1552-e06e-4a6b-bd67-60737684a617 21695-182 HUMAN PRESCRIPTION DRUG Thermazene Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 19851223 NDA NDA018810 Rebel Distributors Corp SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 21695-183_3740dcc6-9ee8-4187-9112-632050043240 21695-183 HUMAN PRESCRIPTION DRUG Rozerem ramelteon TABLET, FILM COATED ORAL 20050722 NDA NDA021782 Rebel Distributors Corp RAMELTEON 8 mg/1 Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA] 21695-184_ea6968e3-6383-4ff1-8c81-e4a2fdfe749d 21695-184 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide TABLET, FILM COATED ORAL 20010228 NDA NDA021169 Rebel Distributors Corp GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 21695-185_9b245d7c-00c0-472e-b213-13fbe9973ee1 21695-185 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Nystatin and Triamcinolone Acetonide CREAM TOPICAL 19871222 ANDA ANDA062364 Rebel Distributors Corp NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-186_e5a2f3a5-2b9d-4d02-ad5c-e6a890569363 21695-186 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium and Prednisolone Sodium Phosphate sulfacetamide sodium and prednisolone sodium phosphate SOLUTION OPHTHALMIC 19951229 ANDA ANDA074449 Rebel Distributors Corp PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM 2.5; 100 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-187_d7a27e38-0553-4d4b-8438-fed235e9b989 21695-187 HUMAN PRESCRIPTION DRUG GENTAMICIN SULFATE gentamicin sulfate SOLUTION OPHTHALMIC 19841010 ANDA ANDA062452 Rebel Distributors Corp GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 21695-188_a76947bd-0430-4d79-b4c1-9d1746bc7f84 21695-188 HUMAN PRESCRIPTION DRUG Mupirocin mupirocin OINTMENT TOPICAL 20051130 ANDA ANDA065192 Rebel Distributors Corp. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 21695-189_063728a5-87b5-4b53-957a-d8e497fcf8b0 21695-189 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 Rebel Distributors Corp TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-191_15dd2f41-952b-40d2-a9bb-5e1cb8802e5e 21695-191 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Rebel Distributors Corp BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 21695-192_65b71a14-dcb5-4123-b4c5-033c9e16a22a 21695-192 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 19951030 ANDA ANDA064064 Rebel Distributors Corp BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 10000 ug/g; mg/g; mg/g Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 21695-193_8e80f9d8-2577-4fd9-a455-e6c6dc244c3a 21695-193 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Rebel Distributors Corp FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 21695-194_75ab9c13-3227-4f20-a8a1-891a4380c085 21695-194 HUMAN OTC DRUG Triple Antibiotic Neomycin and Polymyxin B Sulfates and Bacitracin Zinc OINTMENT TOPICAL 20100106 OTC MONOGRAPH FINAL part333B Rebel Distributors Corp BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [USP'U]/g; mg/g; [USP'U]/g 21695-195_4b044819-2959-4914-b564-d944201246fd 21695-195 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20090909 ANDA ANDA076008 Rebel Distributors Corp BUSPIRONE HYDROCHLORIDE 30 mg/1 21695-196_9e0bdea8-df9b-4873-b24b-919cebff5edd 21695-196 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER ORAL; RESPIRATORY (INHALATION) 20010205 NDA NDA021077 Rebel Distributors Corp. FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 250; 50 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-197_9e0bdea8-df9b-4873-b24b-919cebff5edd 21695-197 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER ORAL; RESPIRATORY (INHALATION) 20010305 NDA NDA021077 Rebel Distributors Corp. FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 500; 50 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-198_29d24a6d-f9c1-4300-97c7-fec26bdbc22b 21695-198 HUMAN PRESCRIPTION DRUG Albuterol Albuterol AEROSOL, METERED ORAL 19960814 ANDA ANDA072273 Rebel Distributors Corp ALBUTEROL 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 21695-201_df79a35c-ce5c-452e-b81e-50a014fc94f4 21695-201 HUMAN PRESCRIPTION DRUG clobetasol propionate clobetasol propionate CREAM TOPICAL 19960930 ANDA ANDA074392 Rebel Distributors Corp CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-202_848653f3-ea81-4416-94a5-9dc0327cd2e3 21695-202 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 Rebel Distributors Corp CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 21695-203_330ac1f7-d583-454d-96bf-37c5af31a369 21695-203 HUMAN PRESCRIPTION DRUG TobraDex tobramycin and dexamethasone SUSPENSION OPHTHALMIC 19880818 NDA NDA050592 Rebel Distributors Corp DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-204_f54c1882-ca08-47f3-9c02-93551f39905e 21695-204 HUMAN PRESCRIPTION DRUG Tobramycin tobramycin SOLUTION OPHTHALMIC 19940525 ANDA ANDA063176 Rebel Distributors Corp TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 21695-205_56145d1a-1c0c-4c39-951e-45b9f324abcb 21695-205 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Rebel Distributors Corp TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-206_3bff1c25-c6c2-4c7d-a14e-be7c3c3d4ab8 21695-206 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 19861216 ANDA ANDA089414 Rebel Distributors Corp HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-207_09ba89a0-3b29-4cbe-8ff6-1d2487b95caf 21695-207 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19840626 ANDA ANDA019117 Rebel Distributors Corp FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-208_48b10c63-5d7a-4841-9faa-17ac3d4873d1 21695-208 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Rebel Distributors Corp HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 21695-209_fef4844c-2b44-4e5c-9da3-e5b2214c9e8d 21695-209 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 19950612 ANDA ANDA089718 Rebel Distributors Corp ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 21695-210_b5e00846-c681-472a-a8eb-78215e6d8a1b 21695-210 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 Rebel Distributors Corp. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 21695-211_c298d925-bf40-442d-9041-dea5c50fb60b 21695-211 HUMAN PRESCRIPTION DRUG Ambien zolpidem tartrate TABLET, FILM COATED ORAL 20090630 NDA NDA019908 Rebel Distributors Corp. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 21695-212_c298d925-bf40-442d-9041-dea5c50fb60b 21695-212 HUMAN PRESCRIPTION DRUG Ambien zolpidem tartrate TABLET, FILM COATED ORAL 20090630 NDA NDA019908 Rebel Distributors Corp. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 21695-213_e242ca9c-63bc-44a3-abcf-99632e7703fa 21695-213 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20090630 NDA NDA021774 Rebel Distributors Corp. ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 21695-214_6d794bf5-8ce7-449c-9cc5-d3b6b0380cfb 21695-214 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021030 ANDA ANDA065101 Rebel Distributors Corp. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 21695-215_6d794bf5-8ce7-449c-9cc5-d3b6b0380cfb 21695-215 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021029 ANDA ANDA065096 Rebel Distributors Corp. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 21695-216_9eb22e92-a577-43be-b3b6-1a5aacf3092e 21695-216 HUMAN PRESCRIPTION DRUG Antipyrine and Benzocaine Antipyrine and Benzocaine SOLUTION AURICULAR (OTIC) 20090430 UNAPPROVED DRUG OTHER Rebel Distributors Corp ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 21695-217_0eefdd8d-7745-47ae-a204-f35687f3db11 21695-217 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Rebel Distributors Corp. BUSPIRONE HYDROCHLORIDE 10 mg/1 21695-218_1971dce3-875a-43e7-aafc-528600da92b5 21695-218 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine CAPSULE ORAL 19970228 ANDA ANDA040204 Rebel Distributors Corp. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 21695-219_8a8a81a4-6768-4ec0-b6ad-224788bcc59a 21695-219 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19990226 ANDA ANDA040230 Rebel Distributors Corp DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 21695-220_3607bed9-64f3-4b14-9b4d-7cc70dc8b185 21695-220 HUMAN PRESCRIPTION DRUG Estazolam Estazolam TABLET ORAL 19970819 ANDA ANDA074818 Rebel Distributors Corp ESTAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-221_78eea56d-15a6-4ceb-b755-d1a3e9707f32 21695-221 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, FILM COATED ORAL 19980220 NDA NDA020829 Rebel Distributors Corp MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 21695-222_a8c12387-4b2b-49c2-b9c5-112ffb133950 21695-222 HUMAN PRESCRIPTION DRUG acetic acid acetic acid SOLUTION AURICULAR (OTIC) 20100122 NDA NDA012179 Rebel Distributors Corp ACETIC ACID 20.65 mg/mL 21695-223_17a20462-d9d2-43ac-bcad-603e8cc76e3b 21695-223 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 19950117 NDA NDA020241 Rebel Distributors Corp LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 21695-224_17a20462-d9d2-43ac-bcad-603e8cc76e3b 21695-224 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 19950117 NDA NDA020241 Rebel Distributors Corp LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 21695-225_7b069c49-007c-4f77-878c-0a6c564e2717 21695-225 HUMAN PRESCRIPTION DRUG Lunesta eszopiclone TABLET, COATED ORAL 20090101 NDA NDA021476 Rebel Distributors Corp ESZOPICLONE 2 mg/1 CIV 21695-226_7b069c49-007c-4f77-878c-0a6c564e2717 21695-226 HUMAN PRESCRIPTION DRUG Lunesta eszopiclone TABLET, COATED ORAL 20090101 NDA NDA021476 Rebel Distributors Corp ESZOPICLONE 3 mg/1 CIV 21695-227_7332e0ea-fbd0-43fb-8d1e-f7068504c61d 21695-227 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 NDA NDA078525 Rebel Distributors Corp LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 21695-228_7332e0ea-fbd0-43fb-8d1e-f7068504c61d 21695-228 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 NDA NDA078525 Rebel Distributors Corp LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 21695-229_7332e0ea-fbd0-43fb-8d1e-f7068504c61d 21695-229 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 NDA NDA078525 Rebel Distributors Corp LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 21695-230_2564fc90-9492-448e-a64f-ee569d7853e6 21695-230 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Rebel Distributors Corp. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-231_2564fc90-9492-448e-a64f-ee569d7853e6 21695-231 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Rebel Distributors Corp. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-232_74ce605d-b493-4b95-9d59-9253f81f4e20 21695-232 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20060809 NDA NDA021487 Rebel Distributors Corp MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 21695-233_89f08066-5ea7-4830-ab8f-8c6a04952604 21695-233 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20110308 ANDA ANDA040545 Rebel Distributors Corp ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 21695-234_8b79d52e-e6e5-4aaf-8835-242c72d6ee38 21695-234 HUMAN PRESCRIPTION DRUG PROVIGIL MODAFINIL TABLET ORAL 20050603 NDA NDA020717 Rebel Distributors Corp MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 21695-235_8b79d52e-e6e5-4aaf-8835-242c72d6ee38 21695-235 HUMAN PRESCRIPTION DRUG PROVIGIL MODAFINIL TABLET ORAL 20040119 NDA NDA020717 Rebel Distributors Corp MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 21695-236_263d7146-791a-49a3-9886-7f4631ecf968 21695-236 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen tramadol hydrochloride and acetaminophen TABLET ORAL 20050421 ANDA ANDA076475 Rebel Distributors Corp ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 21695-237_a7839c4b-6e6e-444f-997e-2dbe28a80eaa 21695-237 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 19810603 ANDA ANDA087128 Rebel Distributors Corp. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 21695-238_90d64ec4-e3af-4e78-bf7e-9d37699c98d2 21695-238 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19880415 ANDA ANDA071193 Rebel Distributors Corp LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-239_90d64ec4-e3af-4e78-bf7e-9d37699c98d2 21695-239 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19880415 ANDA ANDA071194 Rebel Distributors Corp LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-240_90d64ec4-e3af-4e78-bf7e-9d37699c98d2 21695-240 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19880415 ANDA ANDA071195 Rebel Distributors Corp LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-242_b0826efb-e191-4c84-a1cd-79306fe8ddf9 21695-242 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20090629 ANDA ANDA040419 Rebel Distributors Corp. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII 21695-243_b0826efb-e191-4c84-a1cd-79306fe8ddf9 21695-243 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20090629 ANDA ANDA040419 Rebel Distributors Corp. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 CIII 21695-244_50fca3de-4703-4eb7-8294-1ce8e860a100 21695-244 HUMAN OTC DRUG Childrens Silapap Acetaminophen LIQUID ORAL 19940905 OTC MONOGRAPH NOT FINAL part343 Rebel Distributors Corp ACETAMINOPHEN 160 mg/5mL 21695-245_953ab65b-b157-41b3-8f90-98fa9d7f20c5 21695-245 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19980115 ANDA ANDA074543 Rebel Distributors Corp. ALBUTEROL SULFATE 5 mg/mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 21695-246_66e300a5-f1de-40e0-9b08-8b86e2394016 21695-246 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090601 ANDA ANDA018832 Rebel Distributors Corp. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 21695-247_4f300492-4080-499d-b872-a8bf9de3cc7c 21695-247 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19991229 ANDA ANDA074112 Rebel Distributors Corp. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-248_4f300492-4080-499d-b872-a8bf9de3cc7c 21695-248 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19991229 ANDA ANDA074112 Rebel Distributors Corp. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-249_4f300492-4080-499d-b872-a8bf9de3cc7c 21695-249 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19991229 ANDA ANDA074112 Rebel Distributors Corp. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-250_4f300492-4080-499d-b872-a8bf9de3cc7c 21695-250 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19980325 ANDA ANDA074909 Rebel Distributors Corp. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-251_a2368fd3-124e-476d-a8db-9c45e7423562 21695-251 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 Rebel Distributors Corp. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 21695-252_a2368fd3-124e-476d-a8db-9c45e7423562 21695-252 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 Rebel Distributors Corp. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 21695-253_a2368fd3-124e-476d-a8db-9c45e7423562 21695-253 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085967 Rebel Distributors Corp. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 21695-254_5721945b-269b-428d-9e99-b9da8dfb534f 21695-254 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20090302 ANDA ANDA077712 Rebel Distributors Corp OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 21695-255_a3c08a6d-f986-4efc-9f96-3f0e652704dc 21695-255 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Rebel Distributors Corp ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 21695-256_0eefdd8d-7745-47ae-a204-f35687f3db11 21695-256 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Rebel Distributors Corp. BUSPIRONE HYDROCHLORIDE 5 mg/1 21695-257_6dd09be6-a345-4a42-9b64-51b7808ff45f 21695-257 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 20091215 ANDA ANDA040336 Rebel Distributors Corp. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 21695-259_2ef01a91-e73e-46d6-a6f9-d7d6dae91ea2 21695-259 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride ciprofloxacin hydrochloride SOLUTION OPHTHALMIC 19901231 NDA NDA019992 Rebel Distributors Corp CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 21695-260_087a9ced-9e7b-460e-a825-a9c9f60359cf 21695-260 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090622 ANDA ANDA074569 Rebel Distributors CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-261_087a9ced-9e7b-460e-a825-a9c9f60359cf 21695-261 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090622 ANDA ANDA074569 Rebel Distributors CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-262_087a9ced-9e7b-460e-a825-a9c9f60359cf 21695-262 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090622 ANDA ANDA074569 Rebel Distributors CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-263_2d96a6cb-326f-4c04-b5d7-24d7f7c20699 21695-263 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20091109 ANDA ANDA071307 Rebel Distributors Corp. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-264_2d96a6cb-326f-4c04-b5d7-24d7f7c20699 21695-264 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20091109 ANDA ANDA071321 Rebel Distributors Corp. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-265_2d96a6cb-326f-4c04-b5d7-24d7f7c20699 21695-265 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20091109 ANDA ANDA071322 Rebel Distributors Corp. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-267_1df75cdf-dc04-41f8-846e-77ce9ab24548 21695-267 HUMAN OTC DRUG mapap infants concentrated Acetaminophen SUSPENSION/ DROPS ORAL 19900915 OTC MONOGRAPH NOT FINAL part343 Rebel Distributors Corp ACETAMINOPHEN 80 mg/.8mL 21695-268_b935625d-e9e6-4b5b-a40a-3f4e7f01fa45 21695-268 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20090922 ANDA ANDA076642 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 21695-269_64970a9e-6ab7-410d-820f-7e2c0e4dc494 21695-269 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100210 ANDA ANDA040729 Rebel Distributors Corp. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 21695-270_64970a9e-6ab7-410d-820f-7e2c0e4dc494 21695-270 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100210 ANDA ANDA040748 Rebel Distributors Corp. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 21695-271_64970a9e-6ab7-410d-820f-7e2c0e4dc494 21695-271 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100210 ANDA ANDA040769 Rebel Distributors Corp. ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 21695-272_64970a9e-6ab7-410d-820f-7e2c0e4dc494 21695-272 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100210 ANDA ANDA040746 Rebel Distributors Corp. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 21695-273_ef97de17-13df-40af-bbb9-77135df01e44 21695-273 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100730 ANDA ANDA075659 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 21695-274_ba7676eb-68b0-4f64-aed9-541f0ad49bc8 21695-274 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040757 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 21695-276_8fb45a78-b2d8-45dd-b844-0de21d1fdde9 21695-276 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20050610 NDA NDA021724 Rebel Distributors Corp PREGABALIN 25 mg/1 CV 21695-277_8fb45a78-b2d8-45dd-b844-0de21d1fdde9 21695-277 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20050610 NDA NDA021724 Rebel Distributors Corp PREGABALIN 50 mg/1 CV 21695-278_8fb45a78-b2d8-45dd-b844-0de21d1fdde9 21695-278 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20050610 NDA NDA021724 Rebel Distributors Corp PREGABALIN 75 mg/1 CV 21695-279_22009d23-999c-4fa6-bfe7-21395f577236 21695-279 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081126 ANDA ANDA077715 Rebel Distributors Corp BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 21695-280_91d685d3-6cb0-4414-9f72-10e920ebed8b 21695-280 HUMAN PRESCRIPTION DRUG Propoxyphene Napsylate and Acetaminophen Propoxyphene Napsylate and Acetaminophen TABLET, FILM COATED ORAL 20091201 ANDA ANDA074119 Rebel Distributors Corp. ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 650; 100 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 21695-282_6979644e-0587-4040-b754-5dce5eda87a4 21695-282 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 Rebel Distributors Corp TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-283_09abc9b1-50fc-4c60-a6a1-9772e35b057a 21695-283 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 Rebel Distributors Corp TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-284_1da7457b-7225-4950-8108-bbbd8f78f883 21695-284 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 19940601 ANDA ANDA074224 Rebel Distributors Corp TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-285_f1f62485-4f0a-4f7e-b450-62f9ce20f13f 21695-285 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20091112 ANDA ANDA074131 Rebel Distributors Corp PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-286_ecb65310-e54e-48f8-a61b-4177bac41252 21695-286 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20020813 ANDA ANDA072266 Rebel Distributors Corp BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 21695-287_3bf80420-7482-44c0-a117-30793ba89544 21695-287 HUMAN PRESCRIPTION DRUG Crestor Rosuvastatin calcium TABLET, FILM COATED ORAL 20031125 NDA NDA021366 Rebel Distributors Corp ROSUVASTATIN CALCIUM 10 mg/1 21695-288_3bf80420-7482-44c0-a117-30793ba89544 21695-288 HUMAN PRESCRIPTION DRUG Crestor Rosuvastatin calcium TABLET, FILM COATED ORAL 20040607 NDA NDA021366 Rebel Distributors Corp ROSUVASTATIN CALCIUM 20 mg/1 21695-290_0372f916-0a26-4115-8075-2d575bfbc15e 21695-290 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750603 ANDA ANDA084613 Rebel Distributors Corp DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-291_0950cd08-a48b-4376-9647-da22cf5a8a70 21695-291 HUMAN PRESCRIPTION DRUG PULMICORT FLEXHALER Budesonide AEROSOL, POWDER RESPIRATORY (INHALATION) 20100730 NDA NDA021949 Rebel Distributors Corp BUDESONIDE 90 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-292_2fd193e2-7aa7-4119-b540-7e28e82fbd13 21695-292 HUMAN PRESCRIPTION DRUG ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20050908 NDA NDA021692 Rebel Distributors Corp TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 21695-294_5509ede4-74d3-42af-a1dd-cee95de5d2e6 21695-294 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Rebel Distributors Corp. AMOXICILLIN 400 mg/5mL 21695-295_5649e22a-aec5-4bb8-83d7-35623185bd34 21695-295 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090901 ANDA ANDA079095 Rebel Distributors Corp. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 21695-298_8ff18a70-965a-4d3e-ae3e-b599c4e6763c 21695-298 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19961210 ANDA ANDA074644 Rebel Distributors Corp. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-299_8ff18a70-965a-4d3e-ae3e-b599c4e6763c 21695-299 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19961210 ANDA ANDA074644 Rebel Distributors Corp. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-300_047e8b1b-8888-40b7-b593-434e92eb333c 21695-300 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin (monohydrate/macrocrystals) CAPSULE ORAL 19701125 ANDA ANDA080043 Rebel Distributors Corp NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 21695-301_e039ff7a-285e-4e8e-9584-1642ad5c4c77 21695-301 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Rebel Distributors Corp PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 21695-302_5419f5dd-bf20-4eea-982d-33511a022c38 21695-302 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20100323 ANDA ANDA060704 Rebel Distributors Corp TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 21695-303_1da7457b-7225-4950-8108-bbbd8f78f883 21695-303 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 20090713 ANDA ANDA074224 Rebel Distributors Corp TRIAZOLAM .125 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-304_c46e1443-dffe-47a9-bc9a-acbe3a8b0b41 21695-304 HUMAN OTC DRUG Diphenhydramine Diphenhydramine CAPSULE ORAL 20070101 OTC MONOGRAPH NOT FINAL part348 Rebel Distributors Corp DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 21695-305_9fde9268-d5e8-4402-a429-df55f075861d 21695-305 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19720522 ANDA ANDA080292 Rebel Distributors Corp PREDNISONE 5 mg/1 21695-306_9fde9268-d5e8-4402-a429-df55f075861d 21695-306 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19851204 ANDA ANDA088832 Rebel Distributors Corp PREDNISONE 10 mg/1 21695-307_9fde9268-d5e8-4402-a429-df55f075861d 21695-307 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19740226 ANDA ANDA083677 Rebel Distributors Corp PREDNISONE 20 mg/1 21695-308_e8782624-2e60-4fd3-ba49-bf51d314676b 21695-308 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070027 Rebel Distributors Corp METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 21695-309_e8782624-2e60-4fd3-ba49-bf51d314676b 21695-309 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070033 Rebel Distributors Corp METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 21695-310_e1cfadb7-7370-4735-a87a-071c6eedd87a 21695-310 HUMAN OTC DRUG Arthricream with Aloe Trolamine Salicylate CREAM TOPICAL 20060118 OTC MONOGRAPH NOT FINAL part352 Rebel Distributors Corp TROLAMINE SALICYLATE 10 g/100g 21695-314_0b675f9b-1724-4d56-8e4a-396680de436d 21695-314 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 Rebel Distributors Corp. AMOXICILLIN 250 mg/1 21695-315_0b675f9b-1724-4d56-8e4a-396680de436d 21695-315 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 Rebel Distributors Corp. AMOXICILLIN 500 mg/1 21695-316_8bae9b61-3264-4cba-ad32-dfdec9259af3 21695-316 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Rebel Distributors Corp. CEPHALEXIN 250 mg/1 21695-317_8bae9b61-3264-4cba-ad32-dfdec9259af3 21695-317 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Rebel Distributors Corp. CEPHALEXIN 500 mg/1 21695-318_4cdff640-870e-4de8-885b-0669bfde518d 21695-318 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 19881123 ANDA ANDA062935 Rebel Distributors Corp PENICILLIN V POTASSIUM 500 mg/1 21695-319_e242ca9c-63bc-44a3-abcf-99632e7703fa 21695-319 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20090630 NDA NDA021774 Rebel Distributors Corp. ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 21695-320_10a49211-025b-4d63-b60c-fadfd9b731c0 21695-320 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride TABLET, FILM COATED ORAL 20100113 ANDA ANDA075755 Rebel Distributors Corp FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-321_10a49211-025b-4d63-b60c-fadfd9b731c0 21695-321 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride TABLET, FILM COATED ORAL 20100113 ANDA ANDA075755 Rebel Distributors Corp FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-322_500ca21e-571b-4fa9-8b62-4914b226bf3e 21695-322 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950719 ANDA ANDA077877 Rebel Distributors Corp. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-323_d3e90e8f-d3c9-4c73-975f-206a28e0b103 21695-323 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19911227 ANDA ANDA073352 Rebel Distributors Corp. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-324_d3e90e8f-d3c9-4c73-975f-206a28e0b103 21695-324 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19911227 ANDA ANDA073352 Rebel Distributors Corp. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-325_65e1c3ae-a462-4345-8a28-c7d2c0388af8 21695-325 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 Rebel Distributors Corp EZETIMIBE; SIMVASTATIN 10; 20 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 21695-326_56ffd662-60a6-4b43-a7ea-f778714dfbbd 21695-326 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076402 Rebel Distributors Corp. D&C YELLOW NO. 10 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 21695-327_56ffd662-60a6-4b43-a7ea-f778714dfbbd 21695-327 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076402 Rebel Distributors Corp. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 21695-328_612dfaac-f178-4880-b38d-2456478d738a 21695-328 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Rebel Distributors Corp LISINOPRIL 5 mg/1 21695-329_612dfaac-f178-4880-b38d-2456478d738a 21695-329 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Rebel Distributors Corp LISINOPRIL 10 mg/1 21695-330_612dfaac-f178-4880-b38d-2456478d738a 21695-330 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Rebel Distributors Corp LISINOPRIL 20 mg/1 21695-331_612dfaac-f178-4880-b38d-2456478d738a 21695-331 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Rebel Distributors Corp LISINOPRIL 40 mg/1 21695-332_fd41a51d-d569-4368-a3b1-a12cb2472754 21695-332 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19970917 ANDA ANDA074880 Rebel Distributors Corp. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 21695-333_b844e453-78ff-4c5f-b541-37d33f355a3a 21695-333 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20010529 ANDA ANDA075673 Rebel Distributors Corp BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE .64; 10 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-334_22b7f3d7-7f3e-437f-9326-3eef737edfbb 21695-334 HUMAN OTC DRUG Ear Wax Treatment Carbamide Peroxide SOLUTION/ DROPS AURICULAR (OTIC) 20091026 OTC MONOGRAPH FINAL part344 Rebel Distributors Corp CARBAMIDE PEROXIDE 81.86 mg/mL 21695-335_cf4bd790-291e-4c35-83bb-205fb06753b6 21695-335 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim polymyxin B sulfate and trimethoprim SOLUTION OPHTHALMIC 19980413 ANDA ANDA064211 Rebel Distributors Corp POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 mL/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 21695-336_1b182a47-6803-4b84-882e-544306ab0329 21695-336 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20060131 ANDA ANDA040650 Rebel Distributors Corp CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CV 21695-337_b6c0ff30-03f5-4c1b-9077-f0918cf40a91 21695-337 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride CAPSULE ORAL 19971022 ANDA ANDA074655 Rebel Distributors Corp RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 21695-338_b6c0ff30-03f5-4c1b-9077-f0918cf40a91 21695-338 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride CAPSULE ORAL 19971022 ANDA ANDA074655 Rebel Distributors Corp RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 21695-339_65e1c3ae-a462-4345-8a28-c7d2c0388af8 21695-339 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 Rebel Distributors Corp EZETIMIBE; SIMVASTATIN 10; 40 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 21695-340_9bc31f67-cfce-4ad6-9c07-3845ead3542c 21695-340 HUMAN PRESCRIPTION DRUG Ketoprofen ketoprofen CAPSULE ORAL 20100420 ANDA ANDA074035 Rebel Distributors Corp KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-341_9bc31f67-cfce-4ad6-9c07-3845ead3542c 21695-341 HUMAN PRESCRIPTION DRUG Ketoprofen ketoprofen CAPSULE ORAL 20100420 ANDA ANDA074035 Rebel Distributors Corp KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-342_e475d997-09f2-46b7-9750-6f7c8f032f2b 21695-342 HUMAN OTC DRUG LubriFresh P.M. white petrolatum mineral oil OINTMENT OPHTHALMIC 20111209 OTC MONOGRAPH FINAL part349 Rebel Distributors Corp MINERAL OIL; PETROLATUM 150; 830 mg/g; mg/g 21695-343_afebcc90-e2b5-416d-a041-db2dd593a648 21695-343 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 20100602 ANDA ANDA075227 Rebel Distributors Corp NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-344_6f3e6391-e711-42bd-9d95-ce15d7a44ed5 21695-344 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20081107 ANDA ANDA075360 Rebel Distributors Corp. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-345_81210afd-6505-4d38-ab83-e276ee4ce144 21695-345 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20080201 ANDA ANDA077321 Rebel Distributors Corp LISINOPRIL 2.5 mg/1 21695-346_f32d6e27-5b7b-4b17-af2e-0250447ee560 21695-346 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20060101 ANDA ANDA071250 Rebel Distributors Corp. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 21695-347_4106f9a9-56f2-4c1e-bc52-3151d497c1a9 21695-347 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20100108 OTC MONOGRAPH FINAL part333B Rebel Distributors Corp BACITRACIN ZINC 500 [USP'U]/g 21695-348_56145d1a-1c0c-4c39-951e-45b9f324abcb 21695-348 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Rebel Distributors Corp TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-349_56145d1a-1c0c-4c39-951e-45b9f324abcb 21695-349 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Rebel Distributors Corp TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-350_071e819b-43cd-48f7-b63e-c891936dcfc4 21695-350 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP ORAL 19980130 ANDA ANDA074749 Rebel Distributors Corp ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 21695-352_848653f3-ea81-4416-94a5-9dc0327cd2e3 21695-352 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 Rebel Distributors Corp CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 21695-353_d37b05cd-155b-4ac6-9892-7c82d2f65b5f 21695-353 HUMAN OTC DRUG Saline Mist Saline Mist SPRAY NASAL 20090424 OTC MONOGRAPH FINAL part349 Rebel Distributors Corp SODIUM CHLORIDE 6.5 mg/mL 21695-354_4e10129b-41a3-4572-9564-6f8366b627dc 21695-354 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine TABLET ORAL 20091215 ANDA ANDA086162 Rebel Distributors Corp ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 21695-356_48b10c63-5d7a-4841-9faa-17ac3d4873d1 21695-356 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Rebel Distributors Corp HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 21695-357_5d7c4d41-2df4-42d4-9a3d-0a567519bf2d 21695-357 HUMAN PRESCRIPTION DRUG Exelon rivastigmine PATCH, EXTENDED RELEASE TRANSDERMAL 20091007 NDA NDA022083 Rebel Distributors Corp RIVASTIGMINE 4.6 mg/24[USP'U] Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 21695-358_8cfa527c-69c5-4722-8246-c3b4ce591a5f 21695-358 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate SOLUTION TOPICAL 19981113 ANDA ANDA075205 Rebel Distributors Corp CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-359_bfbc2cfb-8e96-4cf2-81c7-d63a1b7365c4 21695-359 HUMAN PRESCRIPTION DRUG Depakote Divalproex sodium TABLET, EXTENDED RELEASE ORAL 20100607 NDA NDA021168 Rebel Distributors Corp DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 21695-360_656a9b7a-77cc-4fd1-917d-788e046e269c 21695-360 HUMAN PRESCRIPTION DRUG KENALOG-40 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 20090601 NDA NDA014901 Rebel Distributors TRIAMCINOLONE ACETONIDE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-361_0bfe9d76-1b0e-47a4-831d-097168d66577 21695-361 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20010228 NDA NDA021077 Rebel Distributors Corp FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 100; 50 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-362_20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c 21695-362 HUMAN PRESCRIPTION DRUG Kaletra lopinavir and ritonavir TABLET, FILM COATED ORAL 20100618 NDA NDA021906 Rebel Distributors Corp LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] 21695-363_16a5de2d-2f89-4fc2-a1cf-2d6fd11f2748 21695-363 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 19861208 ANDA ANDA071108 Rebel Distributors Corp FLURAZEPAM HYDROCHLORIDE 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-365_8bea1481-939d-4bea-a366-0ea435d81288 21695-365 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 20030227 ANDA ANDA040401 Rebel Distributors Corp PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-366_01c5574c-1056-49c6-af20-e950db3f4139 21695-366 HUMAN PRESCRIPTION DRUG CRIXIVAN indinavir sulfate CAPSULE ORAL 19960313 NDA NDA020685 Rebel Distributors Corp INDINAVIR SULFATE 400 mg/1 21695-367_166abd26-675e-4832-9d18-0567f2a9d4e4 21695-367 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 19951121 NDA NDA020564 Rebel Distributors Corp LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 21695-368_d2ded29a-448d-4c4a-9307-403836a67da4 21695-368 HUMAN PRESCRIPTION DRUG PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS CONJUNCTIVAL 20100622 NDA NDA200890 Rebel Distributors Corp PILOCARPINE HYDROCHLORIDE 10 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 21695-369_1b34c6ec-ac27-455e-976e-d22cf9d81950 21695-369 HUMAN PRESCRIPTION DRUG Zidovudine ZIDOVUDINE TABLET, FILM COATED ORAL 20090701 ANDA ANDA077267 Rebel Distributors Corp ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 21695-370_1f35ed70-4947-4d4d-b4c8-71ce520fc445 21695-370 HUMAN PRESCRIPTION DRUG Cefuroxime axetil Cefuroxime axetil TABLET ORAL 20060329 ANDA ANDA065308 Rebel Distributors Corp CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 21695-371_c1143cd8-4325-4dcf-a12f-8badfdba682f 21695-371 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 Rebel Distributors Corp CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 21695-372_c1143cd8-4325-4dcf-a12f-8badfdba682f 21695-372 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070924 Rebel Distributors Corp CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 21695-373_b581d63f-61cb-41b6-a7ca-24bd0b32a8ae 21695-373 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride CAPSULE, GELATIN COATED ORAL 20020829 NDA NDA021447 Rebel Distributors Corp TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 21695-375_0131d303-52c4-4ea7-a560-b529bb2c1616 21695-375 HUMAN PRESCRIPTION DRUG nizatidine nizatidine CAPSULE ORAL 20020705 ANDA ANDA076178 Rebel Distributors Corp NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 21695-376_23bb4390-7825-4b2c-9dd9-48d2ee90bc6c 21695-376 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080501 NDA NDA020859 Rebel Distributors Corp. ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 21695-377_c1143cd8-4325-4dcf-a12f-8badfdba682f 21695-377 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070923 Rebel Distributors Corp CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 21695-378_48b10c63-5d7a-4841-9faa-17ac3d4873d1 21695-378 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Rebel Distributors Corp HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 21695-380_1648670a-5567-4e17-ba8d-84583b7973c5 21695-380 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070813 ANDA ANDA078050 Rebel Distributors Corp. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 21695-382_77a91c9e-f445-4227-8369-c69837563bb9 21695-382 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 Rebel Distributors Corp DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-383_a7839c4b-6e6e-444f-997e-2dbe28a80eaa 21695-383 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 19810603 ANDA ANDA087127 Rebel Distributors Corp. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 21695-384_61b292ba-a739-444d-896e-be204bfd9a1a 21695-384 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20100201 ANDA ANDA061931 Rebel Distributors Corp. AMOXICILLIN 125 mg/5mL 21695-385_61b292ba-a739-444d-896e-be204bfd9a1a 21695-385 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20100201 ANDA ANDA061931 Rebel Distributors Corp. AMOXICILLIN 250 mg/5mL 21695-386_5dad6fbc-2e4d-49dc-8810-721a7701f01e 21695-386 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 21695-387_e83ebf1a-2719-4f52-a47d-3d5af9e8d6f4 21695-387 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN Base Filmtab ERYTHROMYCIN TABLET, FILM COATED ORAL 19720711 ANDA ANDA061621 Rebel Distributors Corp ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 21695-388_b61c6a09-7764-4a92-93a9-a1356aeeaa9c 21695-388 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine Lidocaine and Prilocaine CREAM TOPICAL 20091106 ANDA ANDA076453 Rebel Distributors Corp LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 21695-389_e83ebf1a-2719-4f52-a47d-3d5af9e8d6f4 21695-389 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN Base Filmtab ERYTHROMYCIN TABLET, FILM COATED ORAL 19720711 ANDA ANDA061621 Rebel Distributors Corp ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 21695-392_787721ba-a8e8-4d43-bfbd-ffe56f939011 21695-392 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 19950401 UNAPPROVED DRUG OTHER Rebel Distributors Corp SALSALATE 750 mg/1 21695-393_0a0aff51-3b61-4cde-a415-0694afec99eb 21695-393 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20100226 ANDA ANDA077690 Rebel Distributors Corp QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 21695-394_0a0aff51-3b61-4cde-a415-0694afec99eb 21695-394 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20100226 ANDA ANDA077690 Rebel Distributors Corp QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 21695-397_6383dc39-15a9-4260-8064-18a8c83004b1 21695-397 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20000501 ANDA ANDA075366 Rebel Distributors Corp SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 21695-399_50630775-7f76-413e-9278-ba298dd7f187 21695-399 HUMAN PRESCRIPTION DRUG Zyvox linezolid TABLET, FILM COATED ORAL 20000418 NDA NDA021130 Rebel Distributors Corp LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] 21695-400_5858f7b7-5351-4b38-9850-f5b285dcd6e7 21695-400 HUMAN OTC DRUG Double Antibiotic Bacitracin Zinc and Polymyxin B Sulfate OINTMENT TOPICAL 20100106 OTC MONOGRAPH FINAL part333B Rebel Distributors Corp BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 1000 [USP'U]/g; [USP'U]/g 21695-401_b58ec5f9-0715-4562-9aeb-915329a4eef8 21695-401 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium SUSPENSION ORAL 20070813 ANDA ANDA065358 Rebel Distributors Corp. AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 21695-403_a5391476-8480-401d-8bb5-0726d8195770 21695-403 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Rebel Distributors Corp DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 21695-404_a5391476-8480-401d-8bb5-0726d8195770 21695-404 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Rebel Distributors Corp DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 21695-406_876466eb-2e9d-4025-ba4f-359174181986 21695-406 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 19971031 ANDA ANDA075079 Rebel Distributors Corp. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 21695-407_69e66f08-be0b-4120-9a30-333b34ad3507 21695-407 HUMAN PRESCRIPTION DRUG TriNessa Norgestimate and Ethinyl Estradiol KIT 20070817 NDA NDA019697 Rebel Distributors Corp 21695-408_dfd30506-59e5-4578-879e-fbd6fdd90515 21695-408 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19921105 ANDA ANDA073186 Rebel Distributors Corp DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 21695-410_dfd30506-59e5-4578-879e-fbd6fdd90515 21695-410 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19921105 ANDA ANDA072838 Rebel Distributors Corp DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 21695-411_313ca4f1-7c05-4c8e-b5dd-69eef717bc3c 21695-411 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET ORAL 20030819 ANDA ANDA076794 Rebel Distributors Corp CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 21695-413_284a3c3d-170c-47af-8880-3273d9fb3872 21695-413 VACCINE Tetanus and Diphtheria Toxoids Adsorbed Tetanus and Diphtheria Toxoids Adsorbed INJECTION INTRAMUSCULAR 19671013 BLA BLA101322 Rebel Distributors CLOSTRIDIUM TETANI; CORYNEBACTERIUM DIPHTHERIAE 2; 2 1/.5mL; 1/.5mL 21695-415_2d821387-4b4f-4fe3-825e-750f49755baf 21695-415 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20100407 ANDA ANDA089685 Rebel Distributors Corp PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 21695-416_5dda7621-5438-4522-8be0-bc2e8dc418c5 21695-416 HUMAN PRESCRIPTION DRUG Tobramycin and Dexamethasone Tobramycin and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19880818 NDA NDA050592 Rebel Distributors Corp DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-417_4067a52d-c3fa-4531-8e4f-9675e494065f 21695-417 HUMAN PRESCRIPTION DRUG VALPROIC ACID valproic acid CAPSULE, LIQUID FILLED ORAL 19930629 ANDA ANDA073484 Rebel Distributors Corp VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 21695-418_432287dc-6d16-4a64-bc5f-ec1327104f7e 21695-418 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET ORAL 20100128 ANDA ANDA064013 Rebel Distributors Corp. AMOXICILLIN 250 mg/1 21695-420_07f01136-4649-4c5d-93c5-a8a7dbced9a1 21695-420 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20040923 ANDA ANDA076925 Rebel Distributors Corp IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-421_b7aa9721-3d25-417f-a88d-b8b740819487 21695-421 HUMAN OTC DRUG Cheratussin AC codeine phosphate and guaifenesin LIQUID ORAL 19960901 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 21695-422_19df63de-9f44-40ce-9a4f-0c96345b8a23 21695-422 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION INTRAVENOUS 20060828 ANDA ANDA077782 Rebel Distributors Corp CIPROFLOXACIN 10 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 21695-423_537a2996-2607-4ad1-9ce3-36dd8a3f5dfb 21695-423 HUMAN PRESCRIPTION DRUG VENTOLINHFA HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 Rebel Distributors Corp. ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 21695-424_6e8f9e57-8376-4ce5-8ef0-50b3dd3e1168 21695-424 HUMAN PRESCRIPTION DRUG Sterile Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065397 Rebel Distributors Corp VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 21695-425_0d527c1c-19c5-4199-a51d-b953798d42a3 21695-425 HUMAN PRESCRIPTION DRUG ARTHROTEC diclofenac sodium and misoprostol TABLET, FILM COATED ORAL 19971224 NDA NDA020607 Rebel Distributors Corp. DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 21695-427_b757af04-e516-4ac7-8a2f-45fffab86c5d 21695-427 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20060207 ANDA ANDA065311 Rebel Distributors Corp CEFADROXIL 500 mg/1 21695-428_f3127fff-2943-424d-8b8b-80aa320a2d07 21695-428 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880524 ANDA ANDA072100 Rebel Distributors Corp DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 21695-432_5914ef00-19b1-4e22-9ad3-2b62b455af9d 21695-432 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20100420 ANDA ANDA074754 Rebel Distributors Corp KETOROLAC TROMETHAMINE 10 mg/1 21695-433_a6cc08b8-146e-430f-af39-8b866698b997 21695-433 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20000427 ANDA ANDA075731 Rebel Distributors Corp CLORAZEPATE DIPOTASSIUM 3.75 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-434_a6cc08b8-146e-430f-af39-8b866698b997 21695-434 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20000427 ANDA ANDA075731 Rebel Distributors Corp CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-436_6c268aa1-7777-4065-8fe2-b2dd0d2cbab8 21695-436 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090612 ANDA ANDA040754 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 21695-437_5d57a327-4bdf-4aaa-88f3-e6754665f330 21695-437 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 Rebel Distributors Corp HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-438_595ee3ac-2f33-4459-87ff-be002928059c 21695-438 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 Rebel Distributors Corp HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 21695-439_7bfa54ff-9a72-45e1-8fe5-e8411f8c6e71 21695-439 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20040514 ANDA ANDA076622 Rebel Distributors Corp OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 21695-440_5b4c09e6-4228-47d5-b8f2-5959f8aede38 21695-440 HUMAN OTC DRUG Banalg Methyl Salicylate LOTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part348 Rebel Distributors Corp MENTHOL; METHYL SALICYLATE 30; 140 mg/g; mg/g 21695-441_f6ffd0d8-3451-425e-921e-faae1c1b8ad3 21695-441 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070789 Rebel Distributors Corp DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 21695-442_44c85649-a82e-4c1e-bf3d-b168296d8d0e 21695-442 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL 20091105 UNAPPROVED DRUG OTHER Rebel Distributors Corp HYOSCYAMINE SULFATE .125 mg/1 21695-443_42e3227a-73eb-4873-99c9-b2edb195027d 21695-443 HUMAN PRESCRIPTION DRUG NEXT CHOICE Levonorgestrel TABLET ORAL 20090721 ANDA ANDA078666 Rebel Distributors Corp. LEVONORGESTREL .75 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 21695-444_c61229e8-75cb-4776-9883-c5630bc38a32 21695-444 HUMAN PRESCRIPTION DRUG Zmax azithromycin POWDER, FOR SUSPENSION ORAL 19950610 NDA NDA050797 Rebel Distributors Corp AZITHROMYCIN 2 g/60mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 21695-446_a2368fd3-124e-476d-a8db-9c45e7423562 21695-446 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 Rebel Distributors Corp. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 21695-448_c6a941a0-67dd-4c2a-accd-3a4578bc409c 21695-448 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide CAPSULE ORAL 20030828 ANDA ANDA076570 Rebel Distributors Corp. TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 21695-449_66091ee0-343a-4a04-a61e-86449943bc36 21695-449 HUMAN PRESCRIPTION DRUG Mefloquine Hydrochloride Mefloquine Hydrochloride TABLET ORAL 20031229 ANDA ANDA076392 Rebel Distributors Corp MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC] 21695-450_dcb552c1-310a-48af-81ad-a74530531dee 21695-450 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 Rebel Distributors Corp NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 21695-453_23a83c87-ad92-46af-aeed-12e93ab3255d 21695-453 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride TABLET ORAL 19730919 ANDA ANDA083426 Rebel Distributors Corp PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 21695-454_430b8bbe-96e2-4300-af13-a0704ac11076 21695-454 HUMAN PRESCRIPTION DRUG ERTACZO ERTACZO CREAM TOPICAL 20031210 ANDA ANDA021385 Rebel Distributors Corp. SERTACONAZOLE NITRATE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 21695-455_8de6a6eb-9ed8-4e05-9a4c-d657b5634f76 21695-455 HUMAN PRESCRIPTION DRUG INVEGA paliperidone TABLET, EXTENDED RELEASE ORAL 20061219 NDA NDA021999 Rebel Distributors Corp PALIPERIDONE 6 mg/1 Atypical Antipsychotic [EPC] 21695-457_e142a363-a8b8-40b9-ae9d-28777367e718 21695-457 HUMAN PRESCRIPTION DRUG ERY-TAB erythromycin TABLET, DELAYED RELEASE ORAL 19720711 ANDA ANDA061621 Rebel Distributors Corp ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 21695-458_3d4be22b-7a8c-4247-ac35-143611342de1 21695-458 HUMAN PRESCRIPTION DRUG Tobrex tobramycin OINTMENT OPHTHALMIC 19811125 NDA NDA050555 Rebel Distributors Corp TOBRAMYCIN 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 21695-459_0b5b9f06-15fc-432d-a891-8d91bf80f2d4 21695-459 HUMAN PRESCRIPTION DRUG Oxistat oxiconazole nitrate LOTION TOPICAL 20060125 NDA NDA020209 Rebel Distributors Corp. OXICONAZOLE NITRATE 30 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 21695-461_2db62c07-21be-4378-82fc-a1bd9dc6e3ba 21695-461 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET ORAL 20091209 ANDA ANDA076502 Rebel Distributors Corp FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 21695-462_2db62c07-21be-4378-82fc-a1bd9dc6e3ba 21695-462 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET ORAL 20091209 ANDA ANDA076502 Rebel Distributors Corp FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 21695-463_8014fa52-6180-4365-8285-0943a036a6f6 21695-463 HUMAN PRESCRIPTION DRUG ACULAR KETOROLAC TROMETHAMINE SOLUTION OPHTHALMIC 19921109 NDA NDA019700 Rebel Distributors Corp. KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-464_a23a1cca-bc3e-48c5-abd9-82eddb52e91b 21695-464 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 Rebel Distributors Corp LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 21695-466_57964c72-5ffe-4548-bca0-a5b0ca57ecb1 21695-466 HUMAN PRESCRIPTION DRUG XYLOCAINE Lidocaine Hydrochloride INJECTION INFILTRATION 19481119 NDA NDA006488 Rebel Distributors Corp LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 21695-467_60cc988d-4175-4d7b-9021-299c46602a4c 21695-467 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20020806 ANDA ANDA076257 Rebel Distributors Corp GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 21695-468_60cc988d-4175-4d7b-9021-299c46602a4c 21695-468 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20020806 ANDA ANDA076257 Rebel Distributors Corp GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 21695-469_e253ec37-78bb-4168-b630-2b7e33607f9d 21695-469 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Rebel Distributors Corp GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 21695-470_e253ec37-78bb-4168-b630-2b7e33607f9d 21695-470 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Rebel Distributors Corp GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 21695-471_495738b9-2511-446b-833c-164c0119035b 21695-471 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Rebel Distributors Corp. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 21695-472_495738b9-2511-446b-833c-164c0119035b 21695-472 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Rebel Distributors Corp. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 21695-473_495738b9-2511-446b-833c-164c0119035b 21695-473 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Rebel Distributors Corp. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 21695-474_c119ed19-5dc6-4c03-b705-2616c65ef041 21695-474 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091111 NDA NDA020406 Rebel Distributors Corp LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 21695-475_70429bdd-af83-4345-99d5-54fde6f28e5e 21695-475 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SOLUTION TOPICAL 20070918 ANDA ANDA078270 Rebel Distributors Corp. CICLOPIROX 71.3 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 21695-477_1893cb9f-bdae-4e17-ac6d-8bef66010d7a 21695-477 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Rebel Distributors Corp CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 21695-478_1893cb9f-bdae-4e17-ac6d-8bef66010d7a 21695-478 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Rebel Distributors Corp CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 21695-483_df79a35c-ce5c-452e-b81e-50a014fc94f4 21695-483 HUMAN PRESCRIPTION DRUG clobetasol propionate clobetasol propionate OINTMENT TOPICAL 19960223 ANDA ANDA074407 Rebel Distributors Corp CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-484_6c692344-4d84-4c92-a917-91e02af1a6c3 21695-484 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20070711 ANDA ANDA077621 Rebel Distributors Corp.. AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 21695-485_f32d6e27-5b7b-4b17-af2e-0250447ee560 21695-485 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20080101 ANDA ANDA072750 Rebel Distributors Corp. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 21695-486_16ea7eee-51c9-4305-9808-358e3ace31bd 21695-486 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20090107 ANDA ANDA040766 Rebel Distributors Corp HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 21695-487_53ac99fe-8ff3-4a6f-b90e-d602e1019acb 21695-487 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Rebel Distributors Corp ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 21695-488_53ac99fe-8ff3-4a6f-b90e-d602e1019acb 21695-488 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Rebel Distributors Corp ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 21695-489_53ac99fe-8ff3-4a6f-b90e-d602e1019acb 21695-489 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Rebel Distributors Corp ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 21695-490_b116f624-85d5-472a-8209-c80eae8204a6 21695-490 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060918 ANDA ANDA078010 Rebel Distirbutors Corp FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 21695-491_b116f624-85d5-472a-8209-c80eae8204a6 21695-491 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060918 ANDA ANDA078010 Rebel Distirbutors Corp FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 21695-494_8ff18a70-965a-4d3e-ae3e-b599c4e6763c 21695-494 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20040115 ANDA ANDA076670 Rebel Distributors Corp. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-496_1061baaf-53f8-4a92-b90f-bcecdf1d183e 21695-496 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19880617 ANDA ANDA072011 Rebel Distributors Corp HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 21695-497_1061baaf-53f8-4a92-b90f-bcecdf1d183e 21695-497 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19920430 ANDA ANDA073281 Rebel Distributors Corp HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 21695-498_32f9efb1-3ab9-4d3c-a3b3-fd94874bea98 21695-498 HUMAN OTC DRUG Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Rebel Distributors Corp LORATADINE 5 mg/5mL 21695-499_0cc678d4-5bef-4802-921a-523ba1e617eb 21695-499 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20100121 UNAPPROVED DRUG OTHER Rebel Distributors Corp LORATADINE 10 mg/1 21695-500_c46e1443-dffe-47a9-bc9a-acbe3a8b0b41 21695-500 HUMAN OTC DRUG Diphenhydramine Diphenhydramine CAPSULE ORAL 20070101 OTC MONOGRAPH NOT FINAL part348 Rebel Distributors Corp DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 21695-501_063728a5-87b5-4b53-957a-d8e497fcf8b0 21695-501 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 Rebel Distributors Corp TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-502_063728a5-87b5-4b53-957a-d8e497fcf8b0 21695-502 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 Rebel Distributors Corp TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-503_3f33ae63-5653-4a75-9f74-19d40ae20209 21695-503 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide OINTMENT TOPICAL 20091007 ANDA ANDA085691 Rebel Distributors Corp TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-504_3f33ae63-5653-4a75-9f74-19d40ae20209 21695-504 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide OINTMENT TOPICAL 20091007 ANDA ANDA085691 Rebel Distributors Corp TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-506_c25ff551-9b15-4348-8d8b-9aeafe264d16 21695-506 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Rebel Distributors Corp. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 21695-507_c25ff551-9b15-4348-8d8b-9aeafe264d16 21695-507 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Rebel Distributors Corp. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 21695-508_c326aa5c-cf35-4c87-9ed2-502bf9babb90 21695-508 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20030528 ANDA ANDA040495 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 660; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 21695-509_42a2586d-b025-4a42-83a3-747a880ed858 21695-509 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE ORAL 19991108 ANDA ANDA040886 Rebel Distributors Corp PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 21695-510_7f871c5e-02e5-40f3-a60d-c9d2e9f5ce66 21695-510 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 19830203 ANDA ANDA087022 Rebel Distributors Corp PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 21695-511_90841684-4f00-450f-b366-6fc914ca8c54 21695-511 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET ORAL 19950424 ANDA ANDA070855 Rebel Distributors Corp VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 21695-512_90841684-4f00-450f-b366-6fc914ca8c54 21695-512 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET ORAL 19960205 ANDA ANDA070856 Rebel Distributors Corp VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 21695-513_29fce92f-babc-45f6-bc50-f3eb5ce7d9fb 21695-513 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040527 Rebel Distributors Corp. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 21695-515_6795ade9-e06e-4daa-bb45-821901a055f5 21695-515 HUMAN PRESCRIPTION DRUG Buprenorphine Hydrochloride Buprenorphine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100712 ANDA ANDA074137 Rebel Distributors Corp BUPRENORPHINE HYDROCHLORIDE .3 mg/mL Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 21695-516_ae1e0d8a-03fc-419b-9d44-afa68fbd5681 21695-516 HUMAN PRESCRIPTION DRUG ULORIC febuxostat TABLET ORAL 20090213 NDA NDA021856 Rebel Distributors Corp FEBUXOSTAT 80 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 21695-517_4abb0813-e080-4bae-b829-e2c29d0a8d4f 21695-517 HUMAN OTC DRUG Delsym Dextromethorphan Polistirex SYRUP ORAL 20090904 NDA NDA018658 Rebel Distributors Corp DEXTROMETHORPHAN 30 mg/5mL 21695-518_4abb0813-e080-4bae-b829-e2c29d0a8d4f 21695-518 HUMAN OTC DRUG Delsym Dextromethorphan Polistirex SYRUP ORAL 20090904 NDA NDA018658 Rebel Distributors Corp DEXTROMETHORPHAN 30 mg/5mL 21695-519_a23a1cca-bc3e-48c5-abd9-82eddb52e91b 21695-519 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 Rebel Distributors Corp LEVOFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 21695-520_f1f62485-4f0a-4f7e-b450-62f9ce20f13f 21695-520 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20091112 ANDA ANDA074131 Rebel Distributors Corp PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-521_7ca6552c-bd9f-4630-b202-38dea8b7d994 21695-521 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 19840226 ANDA ANDA019137 Rebel Distributors Corp. BETAMETHASONE DIPROPIONATE .64 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-522_622ac159-4d19-4c4a-95e2-c3757abf5102 21695-522 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 Rebel Distributors Corp INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-523_4755e174-f5d7-451a-9649-46222a6dfced 21695-523 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 19860212 ANDA ANDA070756 Rebel Distributors Corp INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-524_c40df8f6-8374-4f9b-bfce-94d582470d48 21695-524 HUMAN OTC DRUG Phenylephrine Phenylephrine TABLET ORAL 20100224 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 21695-525_f43da9e1-1ed7-48e6-b6f4-4794ba0644a1 21695-525 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SOLUTION OPHTHALMIC 19881018 ANDA ANDA089560 Rebel Distributors Corp SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 21695-526_31fe1e75-da67-4e6d-a529-8b82905dad45 21695-526 HUMAN PRESCRIPTION DRUG Vivotif-B Vivotif-B CAPSULE ORAL 19891215 BLA BLA103123 Rebel Distributors Corp SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI 2 [CFU]/1 21695-527_fe7adfbd-d1dc-4d50-80bc-0cc826a64d86 21695-527 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 19970528 ANDA ANDA064150 Rebel Distributors Corp RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 21695-528_65edc059-0806-4625-b583-0e36f04cf085 21695-528 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Gramicidin Neomycin sulfate, Polymyxin B Sulfate and Gramicidin SOLUTION/ DROPS OPHTHALMIC 19960131 ANDA ANDA064047 Rebel Distributors Corp GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE .025; 1.75; 10000 mg/mL; mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 21695-529_dd34a5ef-f24d-4e02-a78e-f8b93eae384d 21695-529 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 19760430 ANDA ANDA080693 Rebel Distributors Corp HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-530_c1e57227-6c96-4922-973e-74838ab4c795 21695-530 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION OPHTHALMIC 19950929 ANDA ANDA040074 Rebel Distributors Corp PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] 21695-531_3a2f773d-b67f-4e83-b8d7-fce6b2887efe 21695-531 HUMAN PRESCRIPTION DRUG CIMETIDINE CIMETIDINE TABLET ORAL 19981218 ANDA ANDA075659 Rebel Distributors Corp CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 21695-532_3a2f773d-b67f-4e83-b8d7-fce6b2887efe 21695-532 HUMAN PRESCRIPTION DRUG CIMETIDINE CIMETIDINE TABLET ORAL 20101124 ANDA ANDA075659 Rebel Distributors Corp CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 21695-534_347c802f-4ea9-41d4-80d6-e4a183f22179 21695-534 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Rebel Distributors Corp LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 21695-535_347c802f-4ea9-41d4-80d6-e4a183f22179 21695-535 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Rebel Distributors Corp LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 21695-536_347c802f-4ea9-41d4-80d6-e4a183f22179 21695-536 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Rebel Distributors Corp LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 21695-537_e66b1c3c-9121-4e2a-a8c8-65b2e8c54f52 21695-537 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070227 ANDA ANDA040707 Rebel Distributors Corp HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 21695-538_256bfee6-3e21-4fdb-a1d0-0ef417b8be86 21695-538 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20060801 ANDA ANDA084878 Rebel Distributors Corp HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 21695-539_256bfee6-3e21-4fdb-a1d0-0ef417b8be86 21695-539 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19770201 ANDA ANDA084878 Rebel Distributors Corp HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 21695-544_ee3875c6-5c49-4386-8ad2-5fe3208ed9e9 21695-544 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20050713 ANDA ANDA065228 Rebel Distributors Corp. AMOXICILLIN 875 mg/1 21695-546_d74e93e5-11c9-434e-a60c-4a4f911dd0f8 21695-546 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20020605 ANDA ANDA065066 Rebel Distributors Corp. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 21695-547_2f92c67b-f324-4c4e-89fd-1e0f8af96fba 21695-547 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 19810821 ANDA ANDA087508 Rebel Distributors Corp. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL CV 21695-548_72cd7af3-24c4-4a06-b079-ba47d07d7253 21695-548 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin monohydrate POWDER, FOR SUSPENSION ORAL 20080624 ANDA ANDA065419 Rebel Distributors Corp. AZITHROMYCIN MONOHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 21695-549_72cd7af3-24c4-4a06-b079-ba47d07d7253 21695-549 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin monohydrate POWDER, FOR SUSPENSION ORAL 20080624 ANDA ANDA065419 Rebel Distributors Corp. AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 21695-551_4e334e50-19c4-449b-b77f-549a461c7f84 21695-551 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20100921 ANDA ANDA062703 Rebel Distributors Corp CEPHALEXIN 250 mg/5mL 21695-554_836ebf14-fb11-45c3-9e0c-db1bebcd0f5b 21695-554 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 Rebel Distributors Corp KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 21695-555_836ebf14-fb11-45c3-9e0c-db1bebcd0f5b 21695-555 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 Rebel Distributors Corp KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 21695-556_836ebf14-fb11-45c3-9e0c-db1bebcd0f5b 21695-556 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 Rebel Distributors Corp KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 21695-557_f3a50f13-b028-4135-8f20-bfb62a9bc0a9 21695-557 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20051018 ANDA ANDA065144 Rebel Distributors Corp. CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 21695-558_f3a50f13-b028-4135-8f20-bfb62a9bc0a9 21695-558 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20050825 ANDA ANDA065136 Rebel Distributors Corp. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 21695-559_d291f309-1a61-4e32-a684-5b32e7bcb518 21695-559 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 19680731 ANDA ANDA060456 Rebel Distributors Corp PENICILLIN V POTASSIUM 250 mg/5mL 21695-560_8e80f9d8-2577-4fd9-a455-e6c6dc244c3a 21695-560 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Rebel Distributors Corp FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 21695-561_b6ccbb82-3804-4f02-bf17-f07e22a8b02a 21695-561 HUMAN PRESCRIPTION DRUG Mefloquine Hydrochloride Mefloquine Hydrochloride TABLET ORAL 20100421 ANDA ANDA077699 Rebel Distributors Corp MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC] 21695-562_ec308fcf-ec39-43af-97e3-98aa8ab997f4 21695-562 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615 ANDA ANDA075319 Rebel Distributors Corp KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 21695-563_2fd193e2-7aa7-4119-b540-7e28e82fbd13 21695-563 HUMAN PRESCRIPTION DRUG ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20050908 NDA NDA021692 Rebel Distributors Corp TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 21695-564_c74c9424-278d-4a52-8866-db66f6c3ac67 21695-564 HUMAN PRESCRIPTION DRUG Amantadine HCl Amantadine hydrochloride CAPSULE ORAL 20081101 ANDA ANDA078720 Rebel Distributors Corp. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 21695-565_78eea56d-15a6-4ceb-b755-d1a3e9707f32 21695-565 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 19980220 NDA NDA020830 Rebel Distributors Corp MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 21695-566_da73cc74-908f-4497-8770-6c1d774f5ce2 21695-566 HUMAN OTC DRUG Clearlax polyethylene glycol POWDER, FOR SOLUTION TOPICAL 20091007 ANDA ANDA090685 Rebel Distributors Corp POLYETHYLENE GLYCOL 3350 17 g/1 21695-567_f4ac82b0-d0fb-4720-a277-5b2b8013cb3f 21695-567 HUMAN PRESCRIPTION DRUG Catapres clonidine PATCH, EXTENDED RELEASE TRANSDERMAL 19851001 NDA NDA018891 Rebel Distributors Corp CLONIDINE .1 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 21695-568_6f90218a-1595-4af4-97cb-859b265babf4 21695-568 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20100122 ANDA ANDA076345 Rebel Distributors Corp GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 21695-569_48945996-e8b9-462f-b454-3b11fd844a6d 21695-569 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 19880504 ANDA ANDA089895 Rebel Distributors Corp CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 21695-570_e4c5e195-e3f1-487a-accd-c2c6fbbd7837 21695-570 HUMAN PRESCRIPTION DRUG Carisoprodol and Aspirin Carisoprodol and Aspirin TABLET ORAL 20091001 ANDA ANDA040116 Rebel Distributors Corp ASPIRIN; CARISOPRODOL 325; 200 mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-571_a49905cc-dd53-43a2-8113-d8ada3f8cae9 21695-571 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine Maleate TABLET ORAL 19980301 ANDA ANDA040268 Rebel Distributors Corp PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 21695-572_a49905cc-dd53-43a2-8113-d8ada3f8cae9 21695-572 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine maleate TABLET ORAL 19980301 ANDA ANDA040268 Rebel Distributors Corp PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 21695-573_92b5435b-eab1-4e4e-a689-18dbc84b9984 21695-573 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 Rebel Distributors Corp HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 21695-575_f3516a1d-6f30-42b5-9a7a-07ccff7c58d6 21695-575 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Rebel Distributors Corp ISOSORBIDE MONONITRATE 30 mg/1 21695-576_92c7be7d-8c89-476a-b131-9deef76ed016 21695-576 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 20100118 ANDA ANDA074461 Rebel Distributors Corp INDAPAMIDE 1.25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 21695-578_22009d23-999c-4fa6-bfe7-21395f577236 21695-578 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070613 ANDA ANDA077715 Rebel Distributors Corp BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 21695-579_029f39ed-ec6f-4fdc-bc0d-abfb6784cc91 21695-579 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19960229 ANDA ANDA040144 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 21695-580_5092299c-3782-4ee5-b3e7-4e80bf378e3b 21695-580 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087800 Rebel Distributors Corp PREDNISONE 1 mg/1 21695-581_3f5f2d28-1053-44dd-8f9a-12bcc1172488 21695-581 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline Hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 Rebel Distributors Corp. DOXYCYCLINE HYCLATE 100 mg/1 21695-584_f242cdf5-6921-431f-8add-4d17887ebc93 21695-584 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate CREAM TOPICAL 19850514 ANDA ANDA070062 Rebel Distributors Corp. BETAMETHASONE VALERATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-585_21618014-77c1-4a35-acca-cd5678d7bb89 21695-585 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20100331 ANDA ANDA040445 Rebel Distributors Corp. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 21695-586_eeb337ba-0d7e-42cd-840a-78783b5688d7 21695-586 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate OINTMENT TOPICAL 20091023 ANDA ANDA018865 Rebel Distributors Corp BETAMETHASONE VALERATE 1 mg/g 21695-588_31da4540-1589-492c-8be6-382179e8ece2 21695-588 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19990127 ANDA ANDA074993 Rebel Distributors Corp KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-589_65b2f396-666b-4b08-890f-19429844e74b 21695-589 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Rebel Distributors Corp PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 21695-590_7e23b026-fee4-436a-b378-33d31d6d8b40 21695-590 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20070101 OTC MONOGRAPH NOT FINAL part334 Rebel Distributors Corp DOCUSATE SODIUM 100 mg/1 21695-591_ea6968e3-6383-4ff1-8c81-e4a2fdfe749d 21695-591 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide TABLET, FILM COATED ORAL 20010228 NDA NDA021169 Rebel Distributors Corp GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 21695-592_7cdbf66c-9548-47ac-b79a-10a9934c1a29 21695-592 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Rebel Distributors Corp LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-594_4de8df82-23db-421b-8531-c755854b3e5e 21695-594 HUMAN PRESCRIPTION DRUG RE-PB HYOS ELIXIR BELLADONNA ALKALOIDS W/ PHENOBARBITAL ELIXIR ORAL 20091020 UNAPPROVED DRUG OTHER Rebel Distributors Corp ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] CIV 21695-595_8060a686-f1e1-4171-9b99-28791e502bdb 21695-595 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone neomycin sulfate, polymyxin B sulfate and dexamethasone SUSPENSION OPHTHALMIC 19861117 ANDA ANDA062721 Rebel Distributors Corp DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-597_f31c768e-4156-4ebe-8dce-763bf940ab1b 21695-597 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20090601 ANDA ANDA085588 Rebel Distributors Corp PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 21695-598_7546518f-b90f-477f-8f94-9ed76f98f1d7 21695-598 HUMAN OTC DRUG Polyethylene Glycol 3350, NF Powder for Solution, Laxative Polyethylene Glycol 3350, NF Powder for Solution, Laxative POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090812 Rebel Distributors Corp POLYETHYLENE GLYCOL 3350 17 g/g 21695-599_03601ccc-4a9a-4cb9-9028-281bbed42182 21695-599 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920330 ANDA ANDA073555 Rebel Distributors Corp NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 21695-600_03601ccc-4a9a-4cb9-9028-281bbed42182 21695-600 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920330 ANDA ANDA073556 Rebel Distributors Corp NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 21695-601_f168b0a9-4e9a-47f7-b391-edcea871956e 21695-601 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride TABLET ORAL 20060331 ANDA ANDA077248 Rebel Distributors Corp PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 21695-602_1f1c17ab-5bfb-4084-a89e-f0c71a04dfbc 21695-602 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Rebel Distributors Corp. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 21695-603_1f1c17ab-5bfb-4084-a89e-f0c71a04dfbc 21695-603 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Rebel Distributors Corp. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 21695-604_1f1c17ab-5bfb-4084-a89e-f0c71a04dfbc 21695-604 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Rebel Distributors Corp. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 21695-605_1f1c17ab-5bfb-4084-a89e-f0c71a04dfbc 21695-605 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Rebel Distributors Corp. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 21695-606_6543c6ba-852e-40fb-b7ec-1331b9c83656 21695-606 HUMAN PRESCRIPTION DRUG Soma Carisoprodol TABLET ORAL 20070901 NDA NDA011792 Rebel Distributors Corp CARISOPRODOL 250 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 21695-612_56ffd662-60a6-4b43-a7ea-f778714dfbbd 21695-612 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076402 Rebel Distributors Corp. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 21695-613_c674e1bc-5c8e-4c59-8de5-c7fa5306706d 21695-613 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Rebel Distributors Corp ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 21695-614_389cdebb-55fe-4808-a5b7-0f293d9ee45d 21695-614 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate OINTMENT TOPICAL 19870203 ANDA ANDA071012 Rebel Distributors Corp. BETAMETHASONE DIPROPIONATE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-615_725fb4ac-3bd2-4c0f-829f-a3a40863ebce 21695-615 HUMAN PRESCRIPTION DRUG Flurbiprofen Sodium Flurbiprofen Sodium SOLUTION/ DROPS OPHTHALMIC 19950104 ANDA ANDA074447 Rebel Distributors Corp FLURBIPROFEN SODIUM .242 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-616_b53ab2b3-f8f6-4799-8a8e-221302d975c8 21695-616 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 19960730 ANDA ANDA040105 Rebel Distributors Corp ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 21695-617_d8b466e0-a35e-4fba-9d43-4e6c0122e7ad 21695-617 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE ORAL 20101013 ANDA ANDA075576 Rebel Distributors Corp OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 21695-619_0d0dbb74-4a2c-4a95-b81e-6d008cd88808 21695-619 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040778 Rebel Distributors Corp ACETAMINOPHEN; OXYCODONE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 21695-620_a84712bf-221d-4366-9cf0-b8c19428c276 21695-620 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20080107 ANDA ANDA065434 Rebel Distributors Corp CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 21695-622_a9c339ac-14a5-465e-a4fe-1d361d017ccf 21695-622 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20071214 ANDA ANDA065473 Rebel Distributors Corp CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 21695-623_c674e1bc-5c8e-4c59-8de5-c7fa5306706d 21695-623 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Rebel Distributors Corp ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 21695-624_947e29c2-a270-48e0-ba96-c7ed676db871 21695-624 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA078399 Rebel Distributors Corp KETOROLAC TROMETHAMINE 4 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-627_31f5280d-bed3-4be9-9e03-6d51cf6d9582 21695-627 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19810714 ANDA ANDA087425 Rebel Distributors Corp ISONIAZID 300 mg/1 Antimycobacterial [EPC] 21695-628_fe08bcd5-4d14-4c2d-940c-b7968f9a89f0 21695-628 HUMAN PRESCRIPTION DRUG TobraDex tobramycin and dexamethasone OINTMENT OPHTHALMIC 19880928 NDA NDA050616 Rebel Distributors Corp DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-630_dfb8fc2d-4899-4891-a985-755fbdf1d525 21695-630 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20070702 ANDA ANDA077533 Rebel Distributors Corp TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 21695-633_f990eca6-fe6f-4423-a118-4b7b970995a1 21695-633 HUMAN PRESCRIPTION DRUG Chantix varenicline tartrate TABLET, FILM COATED ORAL 20060510 NDA NDA021928 Rebel Distributors Corp VARENICLINE TARTRATE .5 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] 21695-634_fbb6a064-59a6-4e1c-bbb6-5934c1505c4f 21695-634 HUMAN PRESCRIPTION DRUG Pentazocine HCl and Acetaminophen Pentazocine Hydrochloride and Acetaminophen TABLET ORAL 20000324 ANDA ANDA074699 Rebel Distributors Corp ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE 650; 25 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV 21695-635_bd2f4e87-e595-4099-acb9-e36803170f72 21695-635 HUMAN PRESCRIPTION DRUG Nitroglycerin Slocaps Nitroglycerin Sustained-release capsules CAPSULE ORAL 19820825 UNAPPROVED DRUG OTHER Rebel Distributors Corp NITROGLYCERIN 2.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 21695-636_bd2f4e87-e595-4099-acb9-e36803170f72 21695-636 HUMAN PRESCRIPTION DRUG Nitroglycerin Slocaps Nitroglycerin Sustained-release capsules CAPSULE ORAL 19820825 UNAPPROVED DRUG OTHER Rebel Distributors Corp NITROGLYCERIN 6.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 21695-638_e039ff7a-285e-4e8e-9584-1642ad5c4c77 21695-638 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Rebel Distributors Corp PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 21695-639_39fd1b7e-fac0-4d6f-8bc2-4af6e880a53d 21695-639 HUMAN OTC DRUG Peptic Relief Peptic Relief TABLET ORAL 20111230 OTC MONOGRAPH FINAL part335 Rebel Distributors Corp BISMUTH SUBSALICYLATE 262 mg/1 21695-640_5419f5dd-bf20-4eea-982d-33511a022c38 21695-640 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20100323 ANDA ANDA060704 Rebel Distributors Corp TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 21695-641_ea6fac20-4c6b-42bb-8efd-c43458564fe7 21695-641 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE TOPICAL 20100707 ANDA ANDA040771 Rebel Distributors Corp TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-642_79dd238d-87fe-4d89-bb3f-2677cae25993 21695-642 HUMAN OTC DRUG Flexall Pain Relieving Menthol GEL TOPICAL 19970101 OTC MONOGRAPH NOT FINAL part348 Rebel Distributors Corp MENTHOL .16 g/g 21695-643_29ccf947-91c1-405a-aba6-5889e3c75d70 21695-643 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20050628 ANDA ANDA065148 Rebel Distributors Corp NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 21695-644_5da8f60f-c809-4161-a802-6fe823d532bb 21695-644 HUMAN PRESCRIPTION DRUG Altabax retapamulin OINTMENT TOPICAL 20100107 NDA NDA022055 Rebel Distributors Corp. RETAPAMULIN 10 mg/g pleuromutilin [Chemical/Ingredient],Pleuromutilin Antibacterial [EPC] 21695-649_3087a1cb-fda5-4115-86b6-1cce480a2f8e 21695-649 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20030630 ANDA ANDA040500 Rebel Distributors Corp PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 21695-650_08214b30-3dab-4621-a6c0-6bb68529dee3 21695-650 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Rebel Distributors Corp MILNACIPRAN HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-651_08214b30-3dab-4621-a6c0-6bb68529dee3 21695-651 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Rebel Distributors Corp MILNACIPRAN HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-652_c119ed19-5dc6-4c03-b705-2616c65ef041 21695-652 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091111 NDA NDA020406 Rebel Distributors Corp LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 21695-653_871fc448-dfa7-492b-813c-c37e93e53cdb 21695-653 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071209 Rebel Distributors Corp HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 21695-654_c9c9efaf-983f-4f72-9099-0957fee5396c 21695-654 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060317 ANDA ANDA077634 Rebel Distributors Corp ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-655_f5ce22e8-1a9b-408c-86ae-4084b7afeca1 21695-655 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin CREAM TOPICAL 19981224 ANDA ANDA075264 Rebel Distributors Corp TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 21695-656_6473563d-b4df-4434-a74e-f8fa3cb9994f 21695-656 HUMAN PRESCRIPTION DRUG Aggrenox aspirin and dipyridamole CAPSULE ORAL 19991219 NDA NDA020884 Rebel Distributors Corp. ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 21695-657_7db112de-473a-4407-bc1c-35d0ab748700 21695-657 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Rebel Distributors Corp DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-659_3bf80420-7482-44c0-a117-30793ba89544 21695-659 HUMAN PRESCRIPTION DRUG Crestor Rosuvastatin calcium TABLET, FILM COATED ORAL 20041101 NDA NDA021366 Rebel Distributors Corp ROSUVASTATIN CALCIUM 40 mg/1 21695-661_8fb45a78-b2d8-45dd-b844-0de21d1fdde9 21695-661 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20050610 NDA NDA021724 Rebel Distributors Corp PREGABALIN 100 mg/1 CV 21695-662_8fb45a78-b2d8-45dd-b844-0de21d1fdde9 21695-662 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20050610 NDA NDA021724 Rebel Distributors Corp PREGABALIN 150 mg/1 CV 21695-663_8fb45a78-b2d8-45dd-b844-0de21d1fdde9 21695-663 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20050610 NDA NDA021724 Rebel Distributors Corp PREGABALIN 200 mg/1 CV 21695-664_8fb45a78-b2d8-45dd-b844-0de21d1fdde9 21695-664 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Rebel Distributors Corp PREGABALIN 300 mg/1 CV 21695-665_1086a7b4-b89b-4bee-8120-5f752626c046 21695-665 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 19000101 NDA NDA020839 Rebel Distributors Corp CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 21695-666_3599c90e-4cb0-475e-9d1e-8172c8ce014c 21695-666 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20081107 OTC MONOGRAPH FINAL part343 Rebel Distributors Corp ASPIRIN 325 mg/1 21695-667_d82243b9-3e56-4a2b-8750-cb95ec106885 21695-667 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol fumarate TABLET ORAL 20090921 ANDA ANDA078635 Rebel Distributors Corp BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-668_9ab4058c-86fa-41c8-8291-e073fd28257f 21695-668 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860101 ANDA ANDA070176 Rebel Distributors Corp PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-669_9ab4058c-86fa-41c8-8291-e073fd28257f 21695-669 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860101 ANDA ANDA070177 Rebel Distributors Corp PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-670_d82243b9-3e56-4a2b-8750-cb95ec106885 21695-670 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol fumarate TABLET ORAL 20090921 ANDA ANDA078635 Rebel Distributors Corp BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-671_c10e3a16-d94f-442f-9303-4ded0adaecc1 21695-671 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 20091118 ANDA ANDA086831 Rebel Distributors Corp CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 21695-672_e463ea06-12a7-463c-90eb-082d0035b55f 21695-672 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Rebel Distributors Corp WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 21695-673_e463ea06-12a7-463c-90eb-082d0035b55f 21695-673 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Rebel Distributors Corp WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 21695-674_e463ea06-12a7-463c-90eb-082d0035b55f 21695-674 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Rebel Distributors Corp WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 21695-675_e463ea06-12a7-463c-90eb-082d0035b55f 21695-675 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Rebel Distributors Corp WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 21695-677_e463ea06-12a7-463c-90eb-082d0035b55f 21695-677 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Rebel Distributors Corp WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 21695-678_cabd1834-7398-497e-b11f-221a25f21a4e 21695-678 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20101001 ANDA ANDA075659 Rebel Distributors Corp DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 21695-679_d0a368ef-a524-4eb4-b984-5ee1d9d5a93d 21695-679 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE Hydralazine Hydrochloride TABLET ORAL 20080912 ANDA ANDA040901 Rebel Distributors Corp HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 21695-680_d0a368ef-a524-4eb4-b984-5ee1d9d5a93d 21695-680 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE Hydralazine Hydrochloride TABLET ORAL 20080912 ANDA ANDA040901 Rebel Distributors Corp HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 21695-681_3f0ec253-6179-4609-8a67-00dbefc55033 21695-681 HUMAN OTC DRUG Mineral Oil Lacri-Lube OINTMENT OPHTHALMIC 20071130 OTC MONOGRAPH FINAL part346 Rebel Distributors Corp MINERAL OIL; PETROLATUM 425; 568 mg/g; mg/g 21695-684_ec6b0a04-3fb3-46ab-bca6-1415d2f4e72b 21695-684 HUMAN OTC DRUG Aspirin EC Aspirin TABLET, COATED ORAL 19930101 OTC MONOGRAPH FINAL part343 Rebel Distributors Corp ASPIRIN 81 mg/1 21695-685_3cb9494c-4d70-4ebd-98ec-0e28021c1fee 21695-685 HUMAN PRESCRIPTION DRUG Tilia Fe Norethindrone Acetate and Ethinyl Estradiol KIT 20101201 ANDA ANDA076629 Rebel Distributors Corp 21695-686_de96e1f5-402c-492f-b0d1-04fc1bc4fd51 21695-686 HUMAN PRESCRIPTION DRUG Perrigo Benzoyl Peroxide hydroalcoholic base benzoyl peroxide GEL TOPICAL 20071004 UNAPPROVED DRUG OTHER Rebel Distributors Corp BENZOYL PEROXIDE 5 g/100g 21695-688_787f49c7-3726-4eee-87f0-0d6ab8fc5f3c 21695-688 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20091130 ANDA ANDA085762 Rebel Distributors Corp ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 21695-689_717c622c-570e-47d4-be73-041a88e8ebf8 21695-689 HUMAN OTC DRUG Siladryl Allergy Medicine diphenhydramine hydrochloride LIQUID ORAL 19970101 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 21695-690_60d1aea0-f106-4b20-8ef4-7a80e37f8a50 21695-690 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION ORAL 19880520 ANDA ANDA062759 Rebel Distributors Corp ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL 200; 600 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 21695-692_4f359545-2248-4f13-9651-c2aad0153ee6 21695-692 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19920430 ANDA ANDA073192 Rebel Distributors Corp LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 21695-693_a74f9195-8a43-428f-9262-a41313165e0a 21695-693 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20001130 ANDA ANDA065062 Rebel Distributors Corp. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 21695-694_d0a368ef-a524-4eb4-b984-5ee1d9d5a93d 21695-694 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE Hydralazine Hydrochloride TABLET ORAL 20080912 ANDA ANDA040901 Rebel Distributors Corp HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 21695-695_d0a368ef-a524-4eb4-b984-5ee1d9d5a93d 21695-695 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE Hydralazine Hydrochloride TABLET ORAL 20080912 ANDA ANDA040901 Rebel Distributors Corp HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 21695-698_56dfd62c-d386-4e9f-9946-07eda94fa122 21695-698 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextromethorphan Hydrobromide Promethazine Hydrochloride and Dextromethorphan Hydrobromide SYRUP ORAL 19850104 ANDA ANDA088864 Rebel Distributors Corp DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 21695-699_f4fdfd83-c078-424b-9b46-d175c8e7f726 21695-699 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20091113 ANDA ANDA078783 Rebel Distributors Corp. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 21695-700_f4fdfd83-c078-424b-9b46-d175c8e7f726 21695-700 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20091113 ANDA ANDA078783 Rebel Distributors Corp. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 21695-701_3e568a2e-421d-4456-a8bf-d983ecee7ad6 21695-701 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 19971229 ANDA ANDA074650 Rebel Distributors Corp SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 21695-703_85f183af-6781-4ceb-9c21-c4ee9a06c355 21695-703 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SYRUP ORAL 19821115 ANDA ANDA087953 Rebel Distributors Corp PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 21695-704_155d0f79-86c2-4096-97f3-5d82762ddc2e 21695-704 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20080116 ANDA ANDA077570 Rebel Distributors Corp FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-705_5379a585-584d-45f5-9113-dffc277d5876 21695-705 HUMAN OTC DRUG Cough Guaifenesin LIQUID ORAL 20091204 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp GUAIFENESIN 100 mg/5mL 21695-707_3c9f9507-8f72-4850-aa43-9ff5532f1396 21695-707 HUMAN PRESCRIPTION DRUG Flector Diclofenac epolamine PATCH TOPICAL 20081117 NDA NDA021234 Rebel Distributors Corp DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-709_d65cd557-92e1-49b0-9ff5-8479b0ed9f76 21695-709 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077946 Rebel Distributors Corp CETIRIZINE HYDROCHLORIDE 10 mg/1 21695-710_888d7749-bdbc-4788-a215-9c0447aee79a 21695-710 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION/ DROPS OPHTHALMIC 20071228 ANDA ANDA078792 Rebel Distributors Corp DICLOFENAC SODIUM 1 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-711_aa6d9e02-0ff8-421d-9ddd-8968f41f0af7 21695-711 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020410 ANDA ANDA075604 Rebel Distributors Corp POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 21695-712_aa6d9e02-0ff8-421d-9ddd-8968f41f0af7 21695-712 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020410 ANDA ANDA075604 Rebel Distributors Corp POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 21695-714_2e1f1640-c6ff-456f-8bec-ec3251065f46 21695-714 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Rebel Distributors Corp LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 21695-715_2016f03e-e7ac-43b6-8244-0389ce057b2b 21695-715 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20090903 ANDA ANDA076690 Rebel Distributors Corp. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-716_2016f03e-e7ac-43b6-8244-0389ce057b2b 21695-716 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20090903 ANDA ANDA076690 Rebel Distributors Corp. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-717_2e1f1640-c6ff-456f-8bec-ec3251065f46 21695-717 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Rebel Distributors Corp LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 21695-719_2016f03e-e7ac-43b6-8244-0389ce057b2b 21695-719 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20090903 ANDA ANDA076690 Rebel Distributors Corp. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-720_2016f03e-e7ac-43b6-8244-0389ce057b2b 21695-720 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20090903 ANDA ANDA076690 Rebel Distributors Corp. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-721_3ec788b9-b851-4022-a3ef-8ec72bc3d258 21695-721 HUMAN PRESCRIPTION DRUG furosemide furosemide INJECTION INTRAMUSCULAR; INTRAVENOUS 19831130 ANDA ANDA018579 Rebel Distributors Corp FUROSEMIDE 10 mg/2mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 21695-722_5b17afd8-de62-4684-b556-d2846eb214b8 21695-722 HUMAN OTC DRUG Senna Plus Senna Plus TABLET ORAL 20090710 OTC MONOGRAPH NOT FINAL part334 Rebel Distributors Corp SENNOSIDES A AND B 8.6 mg/1 21695-723_555ff988-280c-4272-bf1f-a911fe2e584d 21695-723 HUMAN PRESCRIPTION DRUG AMRIX Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071001 NDA NDA021777 Rebel Distributors Corp. CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 21695-724_fc51bad7-8a77-4c0e-9ff8-fa3474796d35 21695-724 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 20090701 ANDA ANDA074649 Rebel Distributors Corp CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 21695-725_5d28721d-097f-400e-8690-d133c76e07be 21695-725 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Rebel Distributors Corp ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-726_8e41b33e-f71f-4a5e-b88f-cdfefb2bee20 21695-726 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate, Aspirin and Caffeine Orphenadrine Citrate, Aspirin and Caffeine TABLET, MULTILAYER ORAL 19961231 ANDA ANDA074654 Rebel Distributors Corp ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE 770; 60; 50 mg/1; mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 21695-728_77a91c9e-f445-4227-8369-c69837563bb9 21695-728 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19830915 ANDA ANDA088306 Rebel Distributors Corp DEXAMETHASONE 1 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-729_72335a37-d685-457c-a431-fd81e4ad9168 21695-729 HUMAN OTC DRUG Loratadine and Pseudoephedrine loratadine and pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Rebel Distributors Corp LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 21695-730_be1b30fc-5b34-409e-b396-bc48aefad214 21695-730 HUMAN PRESCRIPTION DRUG Hydrocortisone Valerate Hydrocortisone Valerate CREAM TOPICAL 19980825 ANDA ANDA075042 Rebel Distributors Corp HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-731_d98e8ba0-5d0d-4a1e-9907-953e7d1e45b7 21695-731 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 20040601 UNAPPROVED DRUG OTHER Rebel Distributors Corp HYDROCORTISONE ACETATE 30 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-732_d709812f-e958-4065-a447-c2c00ddd7677 21695-732 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20101109 ANDA ANDA077836 Rebel Distributors Corp GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 21695-733_63fa5147-fb3e-47ec-bea1-a80e1f551866 21695-733 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20030301 ANDA ANDA076194 Rebel Distributors Corp HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 21695-734_63fa5147-fb3e-47ec-bea1-a80e1f551866 21695-734 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20030301 ANDA ANDA076194 Rebel Distributors Corp HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 21695-735_63fa5147-fb3e-47ec-bea1-a80e1f551866 21695-735 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20030301 ANDA ANDA076194 Rebel Distributors Corp HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 21695-736_bdee074e-e813-4403-897c-1ccb32bd6548 21695-736 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate Neomycin sulfate and Polymyxin B Sulfate, Bacitracin zinc and Hydrocortisone Acetate OINTMENT OPHTHALMIC 19810414 ANDA ANDA062166 Rebel Distributors Corp BACITRACIN ZINC; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 10; 3.5; 10000 g/g; mg/g; mg/g; g/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-737_a70f8ee5-e9c7-41fa-b45d-69e32cd33cf8 21695-737 HUMAN OTC DRUG Q Tussin DM Dextromethorphan HBr and Guaifenesin SYRUP ORAL 19950401 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 21695-738_364238c7-11b0-442e-acd9-4a6f21b9d783 21695-738 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20090924 ANDA ANDA076685 Rebel Distributors Corp SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 21695-739_364238c7-11b0-442e-acd9-4a6f21b9d783 21695-739 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20070202 ANDA ANDA076685 Rebel Distributors Corp SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 21695-740_364238c7-11b0-442e-acd9-4a6f21b9d783 21695-740 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20080721 ANDA ANDA076685 Rebel Distributors Corp SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 21695-741_364238c7-11b0-442e-acd9-4a6f21b9d783 21695-741 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20080708 ANDA ANDA076685 Rebel Distributors Corp SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 21695-742_364238c7-11b0-442e-acd9-4a6f21b9d783 21695-742 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20070523 ANDA ANDA076685 Rebel Distributors Corp SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 21695-743_cd4f6a14-a2eb-4157-83a7-91ab4e9926e5 21695-743 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Rebel Distributors Corp. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 21695-744_cd4f6a14-a2eb-4157-83a7-91ab4e9926e5 21695-744 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Rebel Distributors Corp. ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 21695-745_77a91c9e-f445-4227-8369-c69837563bb9 21695-745 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19820826 ANDA ANDA087916 Rebel Distributors Corp DEXAMETHASONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-746_2001c00c-89ba-4d36-b39b-a5374a368427 21695-746 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Rebel Distributors Corp GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 21695-747_2001c00c-89ba-4d36-b39b-a5374a368427 21695-747 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Rebel Distributors Corp GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 21695-748_3d43dfcf-f3b1-48a5-837c-d8010d45e0f0 21695-748 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 21695-749_3d43dfcf-f3b1-48a5-837c-d8010d45e0f0 21695-749 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 21695-750_3d43dfcf-f3b1-48a5-837c-d8010d45e0f0 21695-750 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 21695-751_1f2e9f8f-0662-4fd4-b53c-776b6a395a30 21695-751 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 21695-752_3d43dfcf-f3b1-48a5-837c-d8010d45e0f0 21695-752 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp. LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 21695-753_1f2e9f8f-0662-4fd4-b53c-776b6a395a30 21695-753 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 21695-754_3d43dfcf-f3b1-48a5-837c-d8010d45e0f0 21695-754 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 21695-755_1f2e9f8f-0662-4fd4-b53c-776b6a395a30 21695-755 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20071001 NDA NDA021210 Rebel Distributors Corp LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 21695-756_3d43dfcf-f3b1-48a5-837c-d8010d45e0f0 21695-756 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 21695-757_1f2e9f8f-0662-4fd4-b53c-776b6a395a30 21695-757 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 21695-758_3d43dfcf-f3b1-48a5-837c-d8010d45e0f0 21695-758 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp. LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 21695-759_3bf80420-7482-44c0-a117-30793ba89544 21695-759 HUMAN PRESCRIPTION DRUG Crestor Rosuvastatin calcium TABLET, FILM COATED ORAL 20050622 NDA NDA021366 Rebel Distributors Corp ROSUVASTATIN CALCIUM 5 mg/1 21695-760_15dd2f41-952b-40d2-a9bb-5e1cb8802e5e 21695-760 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 Rebel Distributors Corp BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 21695-761_fb98a6b8-da0c-40f4-9e53-487b541865b5 21695-761 HUMAN PRESCRIPTION DRUG Nystatin Nystatin CREAM TOPICAL 19930129 ANDA ANDA064022 Rebel Distributors Corp NYSTATIN 100000 mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 21695-762_29757715-e851-4e9f-b0a9-6fc05dda0205 21695-762 HUMAN OTC DRUG Cepacol Sore Throat Benzocaine and Menthol LOZENGE ORAL 20110804 OTC MONOGRAPH NOT FINAL part356 Rebel Distributors Corp BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 21695-763_f5ce22e8-1a9b-408c-86ae-4084b7afeca1 21695-763 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin GEL TOPICAL 20000222 ANDA ANDA075529 Rebel Distributors Corp TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 21695-764_e99ddb19-8169-4ff4-9e23-16f763e8d7e4 21695-764 HUMAN PRESCRIPTION DRUG Prednisone prednisone TABLET ORAL 20020712 ANDA ANDA040256 Rebel Distributors Corp PREDNISONE 5 mg/1 21695-765_e99ddb19-8169-4ff4-9e23-16f763e8d7e4 21695-765 HUMAN PRESCRIPTION DRUG Prednisone prednisone TABLET ORAL 20020712 ANDA ANDA040256 Rebel Distributors Corp PREDNISONE 10 mg/1 21695-766_90668e5a-0c0d-4941-94cf-8b2fba410ed7 21695-766 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET ORAL 19860723 ANDA ANDA089424 Rebel Distributors Corp SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 21695-767_2970fe7e-9e1f-47aa-85ad-663ee15c7e06 21695-767 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20020605 ANDA ANDA065066 Rebel Distributors Corp AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 21695-768_9bec8131-d420-41ea-809c-6607bf5351ea 21695-768 HUMAN PRESCRIPTION DRUG Nitrolingual nitroglycerin SPRAY ORAL 19851031 NDA NDA018705 Rebel Distributors Corp NITROGLYCERIN 400 ug/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] CIII 21695-769_e2f5ed4f-dd97-4dda-83d1-f8edd8786c0e 21695-769 HUMAN PRESCRIPTION DRUG Sprintec Norgestimate and Ethinyl Estradiol KIT 20101122 ANDA ANDA075804 Rebel Distributors Corp 21695-770_7fd4976d-720c-40ee-8723-a703645d4ff0 21695-770 HUMAN PRESCRIPTION DRUG Tri-Sprintec norgestimate and ethinyl estradiol KIT 20110125 ANDA ANDA075808 Rebel Distributors Corp 21695-771_a81dc60e-af42-4d5a-ba21-865fec74ce05 21695-771 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20101012 ANDA ANDA077056 Rebel Distributors Corp PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 21695-772_d291f309-1a61-4e32-a684-5b32e7bcb518 21695-772 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 19680731 ANDA ANDA060456 Rebel Distributors Corp PENICILLIN V POTASSIUM 125 mg/5mL 21695-773_3d6ce551-6a0a-4d40-8592-cd6d92d55913 21695-773 HUMAN PRESCRIPTION DRUG Xodol Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20040623 ANDA ANDA040658 Rebel Distributors Corp. ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 21695-774_3d6ce551-6a0a-4d40-8592-cd6d92d55913 21695-774 HUMAN PRESCRIPTION DRUG Xodol Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20040623 ANDA ANDA040556 Rebel Distributors Corp. ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 21695-775_3d6ce551-6a0a-4d40-8592-cd6d92d55913 21695-775 HUMAN PRESCRIPTION DRUG Xodol Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20040623 ANDA ANDA040556 Rebel Distributors Corp. ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 21695-777_cc6293ae-1f81-4670-84b2-c00422c690ca 21695-777 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Rebel Distributors Corp ISOSORBIDE MONONITRATE 120 mg/1 21695-778_582e1593-1e6c-4ce8-8bae-134fbc3a66f0 21695-778 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20090727 NDA NDA021445 Rebel Distributors Corp EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] 21695-779_fc274f83-4cd6-47bd-b43e-53a0bf345f11 21695-779 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride FOR SUSPENSION ORAL 20100101 NDA NDA022362 Rebel Distributors Corp COLESEVELAM HYDROCHLORIDE 3.75 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 21695-780_c1d62153-8622-40de-a20b-3faecd718736 21695-780 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleate and Hydrochlorothiazide TABLET ORAL 20010918 ANDA ANDA075788 Rebel Distributors Corp ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 21695-781_fc274f83-4cd6-47bd-b43e-53a0bf345f11 21695-781 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride TABLET, FILM COATED ORAL 20000901 NDA NDA021176 Rebel Distributors Corp COLESEVELAM HYDROCHLORIDE 625 mg/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 21695-782_9e8890f0-e04a-4555-ac8d-d1b792a5c276 21695-782 HUMAN PRESCRIPTION DRUG CEFACLOR CEFACLOR SUSPENSION ORAL 19971002 ANDA ANDA064164 Rebel Distributors Corp CEFACLOR 250 mg/5mL 21695-783_8a4c45c0-7eae-4296-ae2e-6d618228dc8b 21695-783 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19950710 ANDA ANDA040014 Rebel Distributors Corp LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 21695-786_09182072-d05e-4cd4-93c0-d1c0abd6069d 21695-786 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20060823 ANDA ANDA077447 Rebel Distributors Corp MOMETASONE FUROATE 1 mg/g 21695-788_1ac2687d-1a70-4a69-b84c-22840925db09 21695-788 HUMAN PRESCRIPTION DRUG HYZAAR losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Rebel Distributors Corp HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 21695-789_4e334e50-19c4-449b-b77f-549a461c7f84 21695-789 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20100921 ANDA ANDA062703 Rebel Distributors Corp CEPHALEXIN 125 mg/5mL 21695-791_137c4e7a-e671-413e-b687-89490ef98974 21695-791 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20071017 NDA NDA022122 Rebel Distributors Corp DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-792_1cb783ed-5496-4b4d-995b-e81157f9f8d1 21695-792 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20080521 ANDA ANDA078230 Rebel Distributors Corp ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 21695-793_88c5b939-a658-4972-b849-e5c00a447b53 21695-793 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090918 ANDA ANDA090429 Rebel Distributors Corp ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 21695-794_1cb783ed-5496-4b4d-995b-e81157f9f8d1 21695-794 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20080521 ANDA ANDA078230 Rebel Distributors Corp ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 21695-795_7892fb39-94c6-41cc-b8cd-d9d145180a96 21695-795 HUMAN PRESCRIPTION DRUG LOVAZA omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20081021 NDA NDA021654 Rebel Distributors Corp OMEGA-3-ACID ETHYL ESTERS 1 g/1 21695-796_e1a80191-fcb5-4aab-a972-accabe6ae9c7 21695-796 HUMAN PRESCRIPTION DRUG Amiodarone hydrochloride Amiodarone hydrochloride TABLET ORAL 20090810 ANDA ANDA079029 Rebel Distributors Corp AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 21695-797_c7bc9486-8e61-4ba1-827f-2cd8c304b454 21695-797 HUMAN PRESCRIPTION DRUG Inspra eplerenone TABLET ORAL 20020927 NDA NDA021437 Rebel Distributors Corp EPLERENONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 21695-798_1cb783ed-5496-4b4d-995b-e81157f9f8d1 21695-798 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20080521 ANDA ANDA078230 Rebel Distributors Corp ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 21695-799_a4fc8ec9-99c6-4739-9f71-0d9062f3ebe9 21695-799 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081001 ANDA ANDA074501 Rebel Distributors Corp NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-800_a4fc8ec9-99c6-4739-9f71-0d9062f3ebe9 21695-800 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081001 ANDA ANDA074501 Rebel Distributors Corp NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-801_e463ea06-12a7-463c-90eb-082d0035b55f 21695-801 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Rebel Distributors Corp WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 21695-802_a4fc8ec9-99c6-4739-9f71-0d9062f3ebe9 21695-802 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081001 ANDA ANDA074501 Rebel Distributors Corp NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-803_a5391476-8480-401d-8bb5-0726d8195770 21695-803 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Rebel Distributors Corp DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 21695-804_f5ce22e8-1a9b-408c-86ae-4084b7afeca1 21695-804 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin CREAM TOPICAL 19981224 ANDA ANDA075265 Rebel Distributors Corp TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 21695-805_9e123aad-40bc-45fa-b0ab-5519fd4355b7 21695-805 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 19981224 ANDA ANDA075213 Rebel Distributors Corp TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 21695-806_656726ed-50cd-4f7e-8e51-e242afd1d9c9 21695-806 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET ORAL 19941001 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 21695-807_b10b3eaf-c28d-4d09-93e0-64c3d4090c78 21695-807 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20071003 ANDA ANDA077410 Rebel Distributors Corp NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 21695-808_4ae433f5-52bb-4403-984c-32f0fad50dd1 21695-808 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20000925 ANDA ANDA075579 Rebel Distributors Corp BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 21695-809_4ae433f5-52bb-4403-984c-32f0fad50dd1 21695-809 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20000925 ANDA ANDA075579 Rebel Distributors Corp BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 21695-810_85b8863e-b8e0-46f4-94a4-7c8e2c66da3f 21695-810 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET ORAL 20050303 UNAPPROVED DRUG OTHER Rebel Distributors Corp NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 21695-811_9c3fc14a-551c-4957-9074-6b27dfd4a29f 21695-811 HUMAN OTC DRUG Benadryl Allergy Diphenhydramine Hydrochloride TABLET, COATED ORAL 20090101 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 21695-812_a00604ff-041d-4ad4-a3bb-d0911bf0727e 21695-812 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075317 Rebel Distributors Corp TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 21695-813_a00604ff-041d-4ad4-a3bb-d0911bf0727e 21695-813 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075317 Rebel Distributors Corp TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 21695-814_e4412a6a-ed4d-410d-8abb-86e1d7b72a3c 21695-814 HUMAN PRESCRIPTION DRUG Propafenone propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110103 ANDA ANDA078540 Rebel Distributors Corp PROPAFENONE 325 mg/1 Antiarrhythmic [EPC] 21695-815_b7b0b1a0-2ab3-4697-bee4-0cd7fd5088b9 21695-815 HUMAN PRESCRIPTION DRUG Clarinex Desloratadine TABLET, FILM COATED ORAL 20020208 NDA NDA021297 Rebel Distributors Corp DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 21695-816_923abdb6-1ec5-415a-9269-67e16e8e1fff 21695-816 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen SOLUTION ORAL 19980313 ANDA ANDA040182 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 167; 2.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 21695-817_9b3db659-f64c-4c48-946a-6b4f1d800eba 21695-817 HUMAN PRESCRIPTION DRUG Divalproex Sodium DR Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20091014 ANDA ANDA078790 Rebel Distributors Corp DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 21695-818_9b3db659-f64c-4c48-946a-6b4f1d800eba 21695-818 HUMAN PRESCRIPTION DRUG Divalproex Sodium DR Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20091014 ANDA ANDA078790 Rebel Distributors Corp DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 21695-819_9b3db659-f64c-4c48-946a-6b4f1d800eba 21695-819 HUMAN PRESCRIPTION DRUG Divalproex Sodium DR Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20091014 ANDA ANDA078790 Rebel Distributors Corp DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 21695-820_e4020ca3-82d0-4668-b4bc-92e4a53c1f4e 21695-820 HUMAN PRESCRIPTION DRUG FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091102 NDA NDA020786 Rebel Distributors Corp FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 21695-821_00bdb48f-8b8f-4cc5-bb63-77213f2279cb 21695-821 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20071226 ANDA ANDA076549 Rebel Distributors Corp RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 21695-822_00bdb48f-8b8f-4cc5-bb63-77213f2279cb 21695-822 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20071226 ANDA ANDA076529 Rebel Distributors Corp RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 21695-823_00bdb48f-8b8f-4cc5-bb63-77213f2279cb 21695-823 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20071226 ANDA ANDA076549 Rebel Distributors Corp RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 21695-826_a1e2c14f-0682-4b19-9159-de0aca1960c6 21695-826 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 19720630 ANDA ANDA080198 Rebel Distributors Corp LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 21695-827_65e1c3ae-a462-4345-8a28-c7d2c0388af8 21695-827 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 Rebel Distributors Corp EZETIMIBE; SIMVASTATIN 10; 80 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 21695-828_52377f5a-0fdc-4ef7-90d1-2fe8c5909286 21695-828 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 Rebel Distributors Corp METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 21695-829_4d8f6f8f-a69a-48db-8ee1-3b23989cb11f 21695-829 HUMAN PRESCRIPTION DRUG FLUOROURACIL fluorouracil CREAM TOPICAL 20080411 ANDA ANDA077524 Rebel Distributors Corp FLUOROURACIL 50 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 21695-830_99aca2c3-afe6-4f74-83b8-beb08bb2b502 21695-830 HUMAN PRESCRIPTION DRUG Fexmid cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20081101 ANDA ANDA071611 Rebel Distributors Corp CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 21695-831_27badbda-3635-444e-8005-5d5ee16f8c3c 21695-831 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20101004 ANDA ANDA078385 Rebel Distributors Corp HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 21695-832_796cf6ad-d86a-4c4e-9372-0eb649d3530d 21695-832 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20091203 ANDA ANDA077135 Rebel Distributors Corp VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 21695-834_c5378585-dd35-4123-82b9-91395b56c3eb 21695-834 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Rebel Distributors Corp ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 21695-835_c5378585-dd35-4123-82b9-91395b56c3eb 21695-835 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Rebel Distributors Corp ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 21695-836_66e300a5-f1de-40e0-9b08-8b86e2394016 21695-836 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090601 ANDA ANDA018832 Rebel Distributors Corp. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 21695-837_cc6293ae-1f81-4670-84b2-c00422c690ca 21695-837 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Rebel Distributors Corp ISOSORBIDE MONONITRATE 60 mg/1 21695-838_d751e65a-5086-4303-864b-bd9ed895a239 21695-838 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 20100121 ANDA ANDA075219 Rebel Distributors Corp DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-839_21c7fb80-4f9f-41eb-bebb-eda511980284 21695-839 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 19970605 ANDA ANDA074821 Rebel Distributors Corp HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 21695-840_25df52b1-c0b3-49ea-b97f-0763b64db011 21695-840 HUMAN OTC DRUG Almacone Almacone LIQUID ORAL 20081111 OTC MONOGRAPH FINAL part331 Rebel Distributors Corp ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE 200; 200 mg/5mL; mg/5mL 21695-843_917f576b-ead7-442d-bf90-7fb981210805 21695-843 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 20031223 ANDA ANDA040496 Rebel Distributors Corp ACETAMINOPHEN; BUTALBITAL; CAFFEINE 750; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 21695-844_5527cd23-567b-4019-8e5c-f71ee7ed2689 21695-844 HUMAN PRESCRIPTION DRUG Terconazole Terconazole CREAM VAGINAL 20050119 ANDA ANDA076043 Rebel Distributors Corp TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 21695-845_3433c754-cc2e-4e72-bd82-16ed4af3144d 21695-845 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 19960209 ANDA ANDA074430 Rebel Distributors Corp DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 21695-846_d8540843-055c-47fb-9cff-81e64b1d41c3 21695-846 HUMAN PRESCRIPTION DRUG COMBIVIR lamivudine and zidovudine TABLET, FILM COATED ORAL 19970930 NDA NDA020857 Rebel Distributors Corp LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 21695-847_a2c2385e-74a8-4a18-92ec-be8a1380e13a 21695-847 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate dexamethasone sodium phosphate SOLUTION OPHTHALMIC 19850116 ANDA ANDA088771 Rebel Distributors Corp DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-849_faf608f3-a13d-4969-b1a6-bb0bc1de2a8e 21695-849 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; PARENTERAL; SOFT TISSUE 20090305 ANDA ANDA040794 Rebel Distributors Corp METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-850_faf608f3-a13d-4969-b1a6-bb0bc1de2a8e 21695-850 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; PARENTERAL; SOFT TISSUE 20090305 ANDA ANDA040794 Rebel Distributors Corp METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-851_133fb50a-68d3-4d1b-a47a-67d07cc48da5 21695-851 HUMAN PRESCRIPTION DRUG PROAIR HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 19810101 NDA NDA021457 Rebel Distributors Corp ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 21695-852_ccc64ee7-f581-493b-b8c2-6147a0db197e 21695-852 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100310 NDA NDA020381 Rebel Distributors Corp NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 21695-853_97191d37-7c2e-48c6-91bf-0631fd7b1dd8 21695-853 HUMAN PRESCRIPTION DRUG Tigan trimethobenzamide hydrochloride INJECTION INTRAMUSCULAR 20071101 NDA NDA017530 Rebel Distributors Corp TRIMETHOBENZAMIDE HYDROCHLORIDE 100 mg/mL Antiemetic [EPC],Emesis Suppression [PE] 21695-854_6791d4f2-c485-4daf-82c7-0cafa9a7a17d 21695-854 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate CREAM VAGINAL 20080101 OTC MONOGRAPH FINAL part333C Rebel Distributors Corp MICONAZOLE NITRATE 20 mg/g 21695-855_6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 21695-855 HUMAN PRESCRIPTION DRUG Enpresse levonorgestrel and ethinyl estradiol KIT 20101220 ANDA ANDA075809 Rebel Distributors Corp 21695-857_2de68f9e-fa13-4b87-84f9-dbb73883ba40 21695-857 HUMAN PRESCRIPTION DRUG Necon Norethindrone and Ethinyl Estradiol KIT 19870129 ANDA ANDA070687 Rebel Distributors Corp 21695-862_e8a485af-a78b-49a0-9bf4-75e1cd5bb740 21695-862 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077802 Rebel Distributors Corp OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-863_e8a485af-a78b-49a0-9bf4-75e1cd5bb740 21695-863 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077802 Rebel Distributors Corp OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-864_e8a485af-a78b-49a0-9bf4-75e1cd5bb740 21695-864 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077802 Rebel Distributors Corp OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 21695-865_ccc64ee7-f581-493b-b8c2-6147a0db197e 21695-865 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970728 NDA NDA020381 Rebel Distributors Corp NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 21695-866_241e7477-ecae-4f84-8410-bbfaa9f57ed0 21695-866 HUMAN PRESCRIPTION DRUG Amlobenz Amlobenz CAPSULE ORAL 20100419 ANDA ANDA077183 Rebel Distributors Corp AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 21695-867_b5504316-3907-444c-b604-ec9a18cdcd6d 21695-867 HUMAN PRESCRIPTION DRUG Mirapex pramipexole dihydrochloride TABLET ORAL 20040101 NDA NDA020667 Rebel Distributors Corp PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 21695-868_98a3ef97-b447-4bfc-b284-13acd00bda5b 21695-868 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100420 ANDA ANDA073568 Rebel Distributors Corp VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 21695-869_95828fad-323e-4510-acbf-6d354b25b887 21695-869 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide SYRUP ORAL 20080208 ANDA ANDA040613 Rebel Distributors Corp HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5; 5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 21695-870_fbc8717c-8980-4cab-9518-84eb732df072 21695-870 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20090327 NDA NDA021282 Rebel Distributors Corp GUAIFENESIN 600 mg/1 21695-871_6bb510c8-2ae2-4159-b4c6-0aec5e64b4c9 21695-871 HUMAN PRESCRIPTION DRUG Relpax eletriptan hydrobromide TABLET, FILM COATED ORAL 20021226 NDA NDA021016 Rebel Distributors Corp ELETRIPTAN HYDROBROMIDE 40 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 21695-872_7c960eb1-839d-4d96-ba70-a5068a7b6a67 21695-872 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Rebel Distributors Corp SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 21695-873_7c960eb1-839d-4d96-ba70-a5068a7b6a67 21695-873 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Rebel Distributors Corp SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 21695-874_7c960eb1-839d-4d96-ba70-a5068a7b6a67 21695-874 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Rebel Distributors Corp SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 21695-875_d0da5393-8c1d-48ce-85e6-22213f6a4ba2 21695-875 HUMAN OTC DRUG OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED NASAL 20081211 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL 21695-876_f30aa4fe-15ac-4412-afae-fae3b940a74c 21695-876 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 20080101 NDA NDA011722 Rebel Distributors Corp DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 21695-877_56ffd662-60a6-4b43-a7ea-f778714dfbbd 21695-877 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076402 Rebel Distributors Corp. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 21695-878_5e652955-bce3-4b0a-a754-739712725aaf 21695-878 HUMAN OTC DRUG Cetirizine Cetirizine LIQUID ORAL 20080617 ANDA ANDA078398 Rebel Distributors Corp CETIRIZINE HYDROCHLORIDE 5 mg/5mL 21695-879_cf051ddf-aca5-4bdc-ac16-27310d5fd59a 21695-879 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 19840220 ANDA ANDA070098 Rebel Distributors Corp METHYLDOPA 250 mg/1 21695-880_cf051ddf-aca5-4bdc-ac16-27310d5fd59a 21695-880 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 19840220 ANDA ANDA070343 Rebel Distributors Corp METHYLDOPA 500 mg/1 21695-881_75d8099b-4e08-43c0-811e-589d4fb52932 21695-881 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxaxin SOLUTION/ DROPS AURICULAR (OTIC) 20080317 ANDA ANDA076616 Rebel Distributors Corp OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 21695-883_1d97ba11-5b69-4ba3-9310-fa000183de43 21695-883 HUMAN PRESCRIPTION DRUG AK-PENTOLATE Cyclopentolate Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19970113 ANDA ANDA040164 Rebel Distributors Corp. CYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL 21695-885_65b2f396-666b-4b08-890f-19429844e74b 21695-885 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Rebel Distributors Corp PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 21695-887_0924758b-9d8c-490a-a8b3-56b5aee12962 21695-887 HUMAN OTC DRUG Infants Silapap Acetaminophen SOLUTION/ DROPS ORAL 19970401 OTC MONOGRAPH NOT FINAL part343 Rebel Distributors Corp ACETAMINOPHEN 80 mg/.8mL 21695-888_fdd0e957-a600-40a3-b9c7-2b0fd98a5b12 21695-888 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate Clindamycin Phosphate SOLUTION TOPICAL 19970605 ANDA ANDA064159 Rebel Distributors Corp CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 21695-889_d1b5762f-307c-4c99-977d-d91d7dd22141 21695-889 HUMAN PRESCRIPTION DRUG Diazepam Diazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19871013 ANDA ANDA071583 Rebel Distributors Corp DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 21695-890_04bcee32-714d-4f7c-866d-7872b0808690 21695-890 HUMAN PRESCRIPTION DRUG Belladonna Alkaloids with Phenobartbital Belladonna Alkaloids with Phenobartbital TABLET ORAL 20040831 UNAPPROVED DRUG OTHER Rebel Distributors Corp ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 21695-892_28e567ca-dd90-45cc-894c-330437497531 21695-892 HUMAN PRESCRIPTION DRUG Econazole Nitrate Econazole Nitrate CREAM TOPICAL 20040623 ANDA ANDA076479 Rebel Distributors Corp ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 21695-894_43fb007c-19bb-4a04-b47b-288a4f464c81 21695-894 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20100312 ANDA ANDA077270 Rebel Distributors Corp GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 21695-896_44c1c923-ddcc-41b0-b710-bb61643593e3 21695-896 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19960809 ANDA ANDA040159 Rebel Distributors Corp. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 21695-898_c7eece80-2d36-4aec-89d7-4924ab2aeb92 21695-898 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 19941001 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 21695-899_5db7f199-8752-4d24-85f7-e34ca8f4d02e 21695-899 HUMAN PRESCRIPTION DRUG PRADAXA dabigatran etexilate mesylate CAPSULE ORAL 20101026 NDA NDA022512 Rebel Distributors Corp DABIGATRAN ETEXILATE MESYLATE 150 mg/1 21695-900_545ae063-21bf-4dc8-9ad0-0c113b1b0dea 21695-900 HUMAN PRESCRIPTION DRUG Sildec PE DM Sildec PE DM SYRUP ORAL 20100331 UNAPPROVED DRUG OTHER Rebel Distributors Corp CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 15; 12.5 mg/5mL; mg/5mL; mg/5mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 21695-901_eb668bf3-aab0-4529-bf8f-e740a5d5f3b8 21695-901 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20080804 ANDA ANDA076768 Rebel Distributors Corp ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 21695-902_eb668bf3-aab0-4529-bf8f-e740a5d5f3b8 21695-902 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20080804 ANDA ANDA076768 Rebel Distributors Corp ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 21695-903_c29995d6-e8f2-4e7b-aa03-6ce5aa0e7710 21695-903 HUMAN OTC DRUG Magnesium Hydroxide Magnesium Hydroxide LIQUID ORAL 20100322 OTC MONOGRAPH FINAL part331 Rebel Distributors Corp MAGNESIUM HYDROXIDE 400 mg/5mL 21695-905_1f949140-68b5-4602-936f-1936e436d553 21695-905 HUMAN PRESCRIPTION DRUG NAPRELAN naproxen sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960105 NDA NDA020353 Rebel Distributors Corp NAPROXEN SODIUM 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-906_1f949140-68b5-4602-936f-1936e436d553 21695-906 HUMAN PRESCRIPTION DRUG NAPRELAN naproxen sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960105 NDA NDA020353 Rebel Distributors Corp NAPROXEN SODIUM 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-907_aa294be5-9015-4f6a-8a92-a71a2b22d1b2 21695-907 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20030421 ANDA ANDA076369 Rebel Distributors Corp PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] 21695-908_1f27bd46-5dde-4b2e-88c0-b450f4b94b84 21695-908 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Rebel Distributors Corp NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 21695-909_6fafbe75-fcae-4afd-9745-02e641cefb31 21695-909 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20061213 ANDA ANDA077899 Rebel Distributors Corp NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 21695-911_46b4392a-47dd-47b5-9f99-13e4c188faa4 21695-911 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20050509 ANDA ANDA076291 Rebel Distributors Corp IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 21695-913_2fd193e2-7aa7-4119-b540-7e28e82fbd13 21695-913 HUMAN PRESCRIPTION DRUG ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20050908 NDA NDA021692 Rebel Distributors Corp TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 21695-914_d4730085-b38e-43ce-bb51-2532da0a3e2b 21695-914 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20091208 ANDA ANDA077245 Rebel Distributors Corp CIPROFLOXACIN 400 mg/40mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 21695-915_297f0888-729c-4ce6-8779-6b239abf3c93 21695-915 HUMAN PRESCRIPTION DRUG AK-Con naphazoline hydrochloride SOLUTION OPHTHALMIC 19740822 ANDA ANDA083590 Rebel Distributors Corp. NAPHAZOLINE HYDROCHLORIDE 1 mg/mL 21695-916_43464a6b-a3b8-445b-b020-cf60f0b5e8a4 21695-916 HUMAN PRESCRIPTION DRUG Amlobenz Amlobenz CAPSULE ORAL 20100419 ANDA ANDA077183 Rebel Distributors Corp AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 21695-917_d73a7aa3-5b5f-4532-9936-752366a2430d 21695-917 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Rebel Distributors Corp VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 21695-918_d73a7aa3-5b5f-4532-9936-752366a2430d 21695-918 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Rebel Distributors Corp VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 21695-919_d73a7aa3-5b5f-4532-9936-752366a2430d 21695-919 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Rebel Distributors Corp VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 21695-924_35b99e65-32d3-43bc-89d9-2e7c7838aa14 21695-924 HUMAN PRESCRIPTION DRUG Xolox Oxycodone HCl and Acetaminophen TABLET ORAL 20090301 ANDA ANDA040676 Rebel Distributors Corp ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 21695-926_843d2e6f-9110-4b0d-894f-63b1b206b5ec 21695-926 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL; SUBLINGUAL 20090921 UNAPPROVED DRUG OTHER Rebel Distributors Corp HYOSCYAMINE SULFATE .125 mg/1 21695-929_e5e84aa0-a99d-47ae-983b-fc03f0f2c754 21695-929 HUMAN OTC DRUG Aprodine Pseudoephedrine HCl and Tripolidine TABLET, FILM COATED ORAL 19930109 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 60; 2.5 mg/1; mg/1 21695-930_785199ea-3bd6-48ea-afd0-e0c4cf39652b 21695-930 HUMAN OTC DRUG Natures Tears Natures Tears SOLUTION/ DROPS OPHTHALMIC 20110329 OTC MONOGRAPH FINAL part349 Rebel Distributors Corp HYPROMELLOSE 2910 (3 MPA.S) 4 mg/mL 21695-931_9ab3a26c-a030-43ff-a68d-f40f1e0c2ab1 21695-931 HUMAN OTC DRUG Allegra D 12 Hour Allergy and Congestion fexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110303 NDA NDA020786 Rebel Distributors Corp FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 21695-933_472e7b07-83fc-4857-9cc0-50e6aa03f10d 21695-933 HUMAN PRESCRIPTION DRUG TERCONAZOLE terconazole CREAM VAGINAL 20040401 NDA NDA019964 Rebel Distributors Corp TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 21695-934_86c26e3c-27f8-4c59-ac5a-10c6435131bc 21695-934 HUMAN OTC DRUG Magnesium Citrate Magnesium Citrate LIQUID ORAL 20090731 OTC MONOGRAPH NOT FINAL part334 Rebel Distributors Corp MAGNESIUM CITRATE 2.62 g/100mL 21695-935_3cd19aeb-0555-44cd-9619-a2490c8c21e1 21695-935 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 19930716 ANDA ANDA074165 Rebel Distributors Corp. CLOTRIMAZOLE 50 mg/g 21695-939_e463ea06-12a7-463c-90eb-082d0035b55f 21695-939 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Rebel Distributors Corp WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 21695-940_e463ea06-12a7-463c-90eb-082d0035b55f 21695-940 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Rebel Distributors Corp WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 21695-941_8c9cb953-0995-4f47-83ee-c8c9dfd1b533 21695-941 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Rebel Distributors Corp OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 21695-943_f6ffd0d8-3451-425e-921e-faae1c1b8ad3 21695-943 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Rebel Distributors Corp DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 21695-944_4eff4778-6ae6-4727-821d-66df5683dd9b 21695-944 HUMAN PRESCRIPTION DRUG DESONIDE DESONIDE CREAM TOPICAL 19920630 ANDA ANDA073548 Rebel Distributors Corp DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-945_b1b95503-1c7a-44e8-b5e0-d50b61db99d5 21695-945 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate KIT 20060510 NDA NDA021928 Rebel Distributors Corp 21695-946_b1b95503-1c7a-44e8-b5e0-d50b61db99d5 21695-946 HUMAN PRESCRIPTION DRUG Chantix varenicline tartrate TABLET, FILM COATED ORAL 20060510 NDA NDA021928 Rebel Distributors Corp VARENICLINE TARTRATE 1 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] 21695-947_ad07e9bf-cc81-4736-86c7-2b2de9386eb2 21695-947 HUMAN PRESCRIPTION DRUG epinephrine epinephrine INJECTION SUBCUTANEOUS 20100331 NDA AUTHORIZED GENERIC NDA020800 Rebel Distributors Corp EPINEPHRINE .3 mg/1 Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 21695-948_b639732f-8eb2-4592-aca3-86faf7e5360b 21695-948 HUMAN PRESCRIPTION DRUG OPANA ER Oxymorphone Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060622 NDA NDA021610 Rebel Distributors Corp OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 21695-949_b639732f-8eb2-4592-aca3-86faf7e5360b 21695-949 HUMAN PRESCRIPTION DRUG OPANA ER Oxymorphone Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060622 NDA NDA021610 Rebel Distributors Corp OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 21695-950_44a4e8de-0430-48f8-8178-093afcded438 21695-950 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20090803 ANDA ANDA076862 Rebel Distributors Corp METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-951_a1b2e514-b75d-4f01-a9fd-83151f0ce813 21695-951 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Rebel Distributors Corp OXYCODONE HYDROCHLORIDE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 21695-952_41fa78f5-8f41-415e-80f3-7fee7091df5e 21695-952 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Rebel Distributors Corp METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-953_087ae128-1a5d-406e-8bd3-15cb640f6922 21695-953 HUMAN PRESCRIPTION DRUG AMRIX Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071001 NDA NDA021777 Rebel Distributors Corp CYCLOBENZAPRINE HYDROCHLORIDE 30 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 21695-954_e08d5f22-f9c3-4627-8e5a-72c95183cf6a 21695-954 HUMAN PRESCRIPTION DRUG TREXIMET sumatriptan succinate and naproxen sodium TABLET, FILM COATED ORAL 20080425 NDA NDA021926 Rebel Distributors Corp NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE 500; 85 mg/1; mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-955_f2073122-5138-41ba-b791-a9b088bb98b7 21695-955 HUMAN PRESCRIPTION DRUG ZOMIG Zolmitriptan SPRAY, METERED NASAL 20100608 NDA NDA021450 Rebel Distributors Corp ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 21695-956_3f30e6a5-f3c0-4c20-b1a2-142575eb0e24 21695-956 HUMAN PRESCRIPTION DRUG MAXALT rizatriptan benzoate TABLET ORAL 19980629 NDA NDA020864 Rebel Distributors Corp RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 21695-957_5fab494d-cda2-4307-af04-0ce5fce1b2f9 21695-957 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 NDA NDA020699 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-958_5fab494d-cda2-4307-af04-0ce5fce1b2f9 21695-958 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 NDA NDA020699 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-959_c809171c-d424-4a17-a98d-f280a892b410 21695-959 HUMAN PRESCRIPTION DRUG Promethegan promethazine hydrochloride SUPPOSITORY RECTAL 20020205 ANDA ANDA040428 Rebel Distributors Corp PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 21695-960_e5bf608e-c6dd-44e8-96aa-ba4660f64de0 21695-960 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Rebel Distributors Corp SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 21695-961_5fab494d-cda2-4307-af04-0ce5fce1b2f9 21695-961 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 NDA NDA020699 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 21695-965_11d1e166-9577-47b0-a338-d11ab3ba44aa 21695-965 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100611 ANDA ANDA077135 Rebel Distributors Corp VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 21695-966_80ed0406-cf05-423e-b5e7-4e544a88b0ed 21695-966 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20100406 ANDA ANDA090528 Rebel Distributors Corp HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 21695-967_289bda32-6198-4072-a9f3-283438bda707 21695-967 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060401 ANDA ANDA076467 Rebel Distributors Corp GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 21695-968_68cca7e1-120c-4ac6-8851-15a17e11bd9f 21695-968 HUMAN PRESCRIPTION DRUG VIGAMOX moxifloxacin hydrochloride SOLUTION OPHTHALMIC 20030507 NDA NDA021598 Rebel Distributors Corp MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 21695-969_895c2307-aeeb-49fd-ac3d-750a463fc3ef 21695-969 HUMAN PRESCRIPTION DRUG CIPRODEX ciprofloxacin and dexamethasone SUSPENSION AURICULAR (OTIC) 20030815 NDA NDA021537 Rebel Distributors Corp CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE 3; 1 mg/mL; mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-970_6243f28a-e7ed-4571-beb3-2562c5e033c7 21695-970 HUMAN PRESCRIPTION DRUG QUADRAPAX Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide ELIXIR ORAL 20110506 UNAPPROVED DRUG OTHER Rebel Distributors Corp ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] CIV 21695-971_0db4485b-2924-4113-af76-117ad48367b6 21695-971 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate Hydrocortisone Butyrate CREAM TOPICAL 20090901 NDA NDA018514 Rebel Distributors Corp HYDROCORTISONE BUTYRATE 1 mg/g 21695-972_7e87a7ee-b16e-464a-a77c-0f7a40e04cf7 21695-972 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20100415 ANDA ANDA077298 Rebel Distributors Corp METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-973_e17b3ec0-7739-4775-b7a2-a262f4f3a836 21695-973 HUMAN PRESCRIPTION DRUG Plan B One-Step levonorgestrel TABLET ORAL 20090710 NDA NDA021998 Rebel Distributors Corp LEVONORGESTREL 1.5 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 21695-975_67cb9ea4-5adb-4a3a-9568-266b6f472078 21695-975 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110209 ANDA ANDA077154 Rebel Distributors Corp FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 21695-978_4339d964-1997-4c0e-973e-aa69b123b33d 21695-978 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl SOLUTION ORAL 19920713 ANDA ANDA073243 Rebel Distributors Corp LOPERAMIDE HYDROCHLORIDE 1 mg/5mL 21695-979_b4b09d4a-dbe9-4f41-ac04-d4f71743722f 21695-979 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide OINTMENT TOPICAL 20110120 ANDA ANDA073481 Rebel Distributors Corp FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-980_f5480c36-4401-49f2-b550-912e01527ac8 21695-980 HUMAN OTC DRUG Docusate Calcium Docusate Calcium CAPSULE ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 Rebel Distributors Corp DOCUSATE CALCIUM 240 mg/1 21695-982_14e43813-665c-4cef-b3b1-60eafc880f41 21695-982 HUMAN PRESCRIPTION DRUG Proctofoam HC hydrocortisone acetate and pramoxine hydrochloride AEROSOL, FOAM TOPICAL 19780726 ANDA ANDA086195 Rebel Distributors Corp HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 100; 100 mg/10g; mg/10g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 21695-985_f9b4404c-67bc-4c8a-aa75-1d668a6eed16 21695-985 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA077308 Rebel Distributors Corp KETOROLAC TROMETHAMINE 4 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 21695-986_213a0003-da2b-4b91-9281-c05a73f94e46 21695-986 HUMAN PRESCRIPTION DRUG Latanoprost Latanoprost SOLUTION/ DROPS OPHTHALMIC 20110322 ANDA ANDA201006 Rebel Distributors Corp LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 21695-987_047340e3-e6fc-42c7-b552-46b633069bd2 21695-987 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20070223 ANDA ANDA040813 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 21695-988_88ff4e25-bef7-4a8b-a292-23878baac116 21695-988 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Rebel Distributors Corp LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-989_41a61cf1-30a3-472b-a592-b17a610daaba 21695-989 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Rebel Distributors Corp LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 21695-990_611e1f43-1442-4cbb-b7eb-b65de15c6c70 21695-990 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100701 ANDA ANDA079220 Rebel Distributors Corp ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 21695-993_2001c00c-89ba-4d36-b39b-a5374a368427 21695-993 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Rebel Distributors Corp GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 21695-994_88ff4e25-bef7-4a8b-a292-23878baac116 21695-994 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Rebel Distributors Corp LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 21695-995_9e8e429c-1960-4acd-8bc5-5002d4c6a6ac 21695-995 HUMAN PRESCRIPTION DRUG Aviane 28 Day levonorgestrel and ethinyl estradiol KIT 19950824 ANDA ANDA075796 Rebel Distributors Corp 21695-996_d346d08d-ebb5-4500-923f-fe111f304876 21695-996 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20111227 ANDA ANDA079081 Rebel Distributors Corp LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 21695-997_a61e6ba8-b342-4815-9623-eb0c319ecc74 21695-997 HUMAN PRESCRIPTION DRUG Lactulose lactulose SOLUTION ORAL 20040419 ANDA ANDA074623 Rebel Distributors Corp LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 21724-701_2787509f-8b55-4f80-a055-970b8e2ece6f 21724-701 HUMAN PRESCRIPTION DRUG Procentra dextroamphetamine sulfate SOLUTION ORAL 20140515 ANDA ANDA040776 Independence Pharmaceuticals, LLC DEXTROAMPHETAMINE SULFATE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 21731-647_4d55f840-8daf-45e7-980d-91a1e4087add 21731-647 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F 18 INJECTION INTRAVENOUS 20111201 ANDA ANDA204525 Centre for Probe Development and Commercialization FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 21749-080_f580d5b2-9dd0-432b-8688-f752d0d58e6f 21749-080 HUMAN OTC DRUG Luxury Foam Antibacterial Chloroxylenol LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL 21749-085_9863ec0b-4005-4bf2-a114-952331508d82 21749-085 HUMAN OTC DRUG Premium Foam Antibacterial Chloroxylenol LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL 21749-095_6413fd5c-f403-4e6c-95e5-a8774f305ede 21749-095 HUMAN OTC DRUG MICRELL Antibacterial Foam Handwash CHLOROXYLENOL LIQUID TOPICAL 20060623 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .005 mg/mL 21749-142_4a2d0c78-5ee5-4613-8af0-5cb2155a2ecf 21749-142 HUMAN OTC DRUG Purell Advanced Hand Sanitizer Moonlit Moments ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-143_b5b99529-2d1a-4a75-a90d-c9b70fe506f5 21749-143 HUMAN OTC DRUG Purell Advanced Hand Sanitizer Tranquil Sunset ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-144_ad6af0f7-a439-47b1-be44-ede5eaeb3809 21749-144 HUMAN OTC DRUG Purell Advanced Hand Sanitizer Revitalizing Rain ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-145_c029e405-764a-439c-9e3f-024dc296c767 21749-145 HUMAN OTC DRUG Purell Advanced Hand Sanitizer Fresh Peach Blossoms ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-146_ba412222-4fd0-4a97-adc6-1b6f3b78b30e 21749-146 HUMAN OTC DRUG Purell Advanced Hand Sanitizer Refreshing Florals ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-147_9ffa8ce8-ec4f-4267-9769-05fd861c7878 21749-147 HUMAN OTC DRUG Purell Advanced Hand Sanitizer Inspiring Island Getaway ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-150_7dc6a64a-302a-4769-a33f-56e75eed6eef 21749-150 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Sweet Plum ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-151_ac14519c-bfcb-42de-a14e-1cb1d55722f2 21749-151 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Wintergreen Mint ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-152_b15f6a5d-704a-43cf-ac1f-fce76ba942b5 21749-152 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer O Christmas Tree Alcohol GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-153_0696705d-05f7-49ee-b510-0e43120e094b 21749-153 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Holiday Spice alcohol GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-250_9999b8d5-34c7-41e7-8928-750348009a20 21749-250 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Winterberry Delight ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-251_246654a0-1ff9-4675-906c-95390a1c6e21 21749-251 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Fresh Peppermint Cheer ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-252_91fbb89b-1d1d-44ec-af30-03d396dcca5c 21749-252 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Aspen Retreat Alcohol GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-253_1365faa3-e359-4135-9dce-7d707f77292a 21749-253 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Winter Wonderland Spice alcohol GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-363_b854e527-5e16-4493-b319-0440fb08a3d9 21749-363 HUMAN OTC DRUG Purell Sanitizing Hand Wipes ethyl alcohol CLOTH TOPICAL 20070122 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc ALCOHOL .62 mL/mL 21749-364_fc19689f-4826-4adf-8292-ea002cc4ad05 21749-364 HUMAN OTC DRUG PURELL Cottony Soft alcohol SWAB TOPICAL 20120224 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .62 mL/mL 21749-366_195f1abe-2cc3-49a9-9e89-fefa7a513f0c 21749-366 HUMAN OTC DRUG Purell Personal Pack Sanitizing alcohol SWAB TOPICAL 20120314 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .62 mL/mL 21749-367_390859de-2d8d-40f8-a0fc-05f7644e266c 21749-367 HUMAN OTC DRUG Purell Alcohol Formulation alcohol SWAB TOPICAL 20120224 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .62 mL/mL 21749-415_6eeacde2-89db-430d-9ca3-0609246891c1 21749-415 HUMAN OTC DRUG TRICLOSAN TRICLOSAN LIQUID TOPICAL 20100310 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc. TRICLOSAN .003 mL/mL 21749-417_c1313d41-2176-425c-b133-e1f895a00180 21749-417 HUMAN OTC DRUG GOJO Antibacterial Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. TRICLOSAN .003 mg/mL 21749-506_a300e028-8c19-4ce4-8901-874cf0b4b1d0 21749-506 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL GEL TOPICAL 20100303 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc. ALCOHOL .62 mL/mL 21749-515_ccf8fd3f-673e-4668-96e0-1cfad1ed6907 21749-515 HUMAN OTC DRUG PURELL Instant Hand Sanitizer Foam (ETHYL ALCOHOL) ALCOHOL GEL TOPICAL 20101214 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .62 mL/mL 21749-520_dd592fe3-1871-4463-a9c2-dedf51aecb85 21749-520 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL GEL TOPICAL 20100304 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc. ALCOHOL .62 mL/mL 21749-523_98fc60fd-efbc-4992-b7ee-300f97b61c2a 21749-523 HUMAN OTC DRUG GOJO E2 Foam Handwash with PCMX GOJO E2 Foam Handwash with PCMX LIQUID TOPICAL 20140915 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .5 1/mL 21749-525_98b92452-3201-413a-b29f-d29b788cf891 21749-525 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL GEL TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-526_3ee3f094-103b-4c87-a761-8d1bf475740f 21749-526 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL GEL TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-527_afcab252-ccd6-45e9-b5c8-74b10ac5bef2 21749-527 HUMAN OTC DRUG Purell Instant Ultra alcohol GEL TOPICAL 20120224 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-530_2754e08b-4bce-445e-b28c-0a77f0cd9275 21749-530 HUMAN OTC DRUG PURELL Advanced Instant Hand Sanitizer Fragrance Free ALCOHOL LIQUID TOPICAL 20140214 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-533_db57037d-8827-4438-9729-1c2c49db529c 21749-533 HUMAN OTC DRUG PROVON Antibacterial Foam Handwash Triclosan LIQUID TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. TRICLOSAN .003 mg/mL 21749-540_8e51388c-0425-4d51-b1bc-aa45edee9acf 21749-540 HUMAN OTC DRUG Antibacterial Plum Foam Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. TRICLOSAN .003 mg/mL 21749-600_37e1f536-a09b-44bc-9ab4-c959a609f42f 21749-600 HUMAN OTC DRUG Primory Clean Skin Antibacterial Ltn Sp Chloroxylenol LIQUID TOPICAL 20130831 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL 21749-607_aab02796-7577-48d0-9637-c5ddb8d0b4ff 21749-607 HUMAN OTC DRUG PURELL SF607 Instant Hand Sanitizing BENZALKONIUM CHLORIDE LIQUID TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL 21749-700_540548fb-7b23-4d4c-bb08-5e4b5dfcd8af 21749-700 HUMAN OTC DRUG PURELL Advanced Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110510 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-701_b85939fe-bc80-4ce6-b737-7fec9231c118 21749-701 HUMAN OTC DRUG PURELL Advanced Skin Nourishing Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110510 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-702_bd308bd4-d38f-4e48-ae52-49ec30c752d5 21749-702 HUMAN OTC DRUG PURELL Advanced Green Certified Instant Hand Sanitizer alcohol GEL TOPICAL 20111215 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-703_3a4ca127-456e-4732-964b-97b62275f5a3 21749-703 HUMAN OTC DRUG PURELL Advanced with Aloe Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110505 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-704_f44219b3-6896-4566-9373-d83918d29878 21749-704 HUMAN OTC DRUG Purell Advanced Refreshing alcohol GEL TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-705_3330c320-49f3-4dd0-a1bd-39c1f9632370 21749-705 HUMAN OTC DRUG Purell Advanced Refreshing Aloe alcohol GEL TOPICAL 20120314 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-706_58adb1ba-73d8-4f6a-9296-269213e2f1e8 21749-706 HUMAN OTC DRUG PURELL Advanced E3 Rated Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130331 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-740_9183ff07-3f0c-401c-8c7d-0d058d14c251 21749-740 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Ocean Kiss alcohol GEL TOPICAL 20111221 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-745_dfaa6e06-b60a-4ece-9a40-8763832a8965 21749-745 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer SpongeBob Splash alcohol GEL TOPICAL 20111221 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-750_d9dfd7fe-6a24-4815-a9c8-4c45b4bf65b3 21749-750 HUMAN OTC DRUG PROVON Antimicrobial Ltn Sp with 0.3% PCMX Chloroxylenol LIQUID TOPICAL 20130831 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL 21749-801_dfa86bfa-0f6a-4a9a-b968-3c15d4a2b2f4 21749-801 HUMAN OTC DRUG PURELL Advanced Skin Nourishing Instant Hand Sanitizer alcohol LIQUID TOPICAL 20111221 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-802_1f78370b-132a-4759-8cbc-b5e093f90f8d 21749-802 HUMAN OTC DRUG PURELL Advanced E3 Rated Instant Hand Sanitizer Foam alcohol LIQUID TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-806_f28b40b7-266b-4a18-8e0c-0dbc132276d0 21749-806 HUMAN OTC DRUG PURELL Advanced Green Certified Instant Hand Sanitizer alcohol LIQUID TOPICAL 20111215 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-807_5853e615-b522-4b1c-9d84-f70242e7a3c4 21749-807 HUMAN OTC DRUG PURELL Advanced Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-911_1e91a2d7-3fab-4eb9-9320-b9fdd7a32978 21749-911 HUMAN OTC DRUG PURELL Sanitizing Wipes Clean Refreshing Scent Benzalkonium Chloride LIQUID TOPICAL 20130915 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. BENZALKONIUM CHLORIDE .00115 1/1 21749-965_f8bb3a71-67d8-435b-9a5b-7649a07b6841 21749-965 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL GEL TOPICAL 20100315 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc. ALCOHOL .62 mL/mL 21749-967_c767f6de-9d6a-4f90-bb42-0e4011ca117d 21749-967 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL GEL TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-975_166c0d2c-f15d-4a8e-9760-9cb4e989a628 21749-975 HUMAN OTC DRUG MICRELL Antibacterial Ltn Sp Chloroxylenol LIQUID TOPICAL 19980730 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL 21749-987_04877aac-afa9-4d44-b129-a0645cac421a 21749-987 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL LIQUID TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-992_e3ed5e0c-1e21-47eb-a999-9c8aa5083dff 21749-992 HUMAN OTC DRUG PURELL Waterless Surgical Scrub alcohol LIQUID TOPICAL 20111215 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL 21749-993_e0ff1078-ae84-446e-8872-db42766dbf9c 21749-993 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc. ALCOHOL .7 mL/mL 21839-011_377bd4d5-77fd-4361-903f-b974c33aa90b 21839-011 HUMAN OTC DRUG Ultra Sensitive Faceblock SPF 25 Titanium Dioxide LOTION TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 Gordon Laboratories, Inc TITANIUM DIOXIDE 4000 mg/50mL 21839-091_6f3d5cc8-cae0-47e5-be32-356236a5613f 21839-091 HUMAN OTC DRUG Waterblock Solar SPF 30 Homosalate, Octinoxate, Octisalate, Octocrylene, and Oxybenzone LIQUID TOPICAL 20051101 OTC MONOGRAPH NOT FINAL part352 Gordon Laboratories, Inc HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 12.5; 9.4; 6.25; 12.5; 6.25 mL/125mL; mL/125mL; mL/125mL; mL/125mL; mL/125mL 21839-101_b9f20f8a-78d0-4269-9b4a-43ed1281017a 21839-101 HUMAN OTC DRUG Multivitamin Bodyblock SPF 20 Avobenzone, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20051101 OTC MONOGRAPH NOT FINAL part352 Gordon Laboratories, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.5; 9.4; 6.25; 3.75 mL/125mL; mL/125mL; mL/125mL; mL/125mL 21839-111_abc25671-26c1-4ed3-a027-8c6e16bb0ec9 21839-111 HUMAN OTC DRUG FACEBLOCK SPF30 SUPER SENSITIVE Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20051109 OTC MONOGRAPH NOT FINAL part352 Gordon Laboratories, Inc TITANIUM DIOXIDE; ZINC OXIDE 3.35; 4.6 mL/50mL; mL/50mL 22100-001_fae61354-a16e-4081-9197-646807f03910 22100-001 HUMAN PRESCRIPTION DRUG Healing Waters White Tea Pear Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 Ningbo Meiduo General Products Co., Ltd ALCOHOL 60 g/100g 22100-002_8ec3b010-6578-4f5a-a7a0-69334d95fb56 22100-002 HUMAN PRESCRIPTION DRUG Healing Waters Peach Nectarine Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 Ningbo Meiduo General Products Co., Ltd ALCOHOL 60 g/100g 22100-003_8a25c4bf-fc89-4547-b991-f5b9f17f2f89 22100-003 HUMAN PRESCRIPTION DRUG Healing Waters Lemon Verbena Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 Ningbo Meiduo General Products Co., Ltd ALCOHOL 60 g/100g 22100-004_5c570163-c35d-4697-8224-f4bf3b4296c2 22100-004 HUMAN PRESCRIPTION DRUG Healing Waters Aloe Cucumber Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 Ningbo Meiduo General Products Co., Ltd ALCOHOL 60 g/100g 22100-005_e6a1ee9b-88ab-4907-a6a5-a4ef0ece5fb6 22100-005 HUMAN PRESCRIPTION DRUG Healing Waters Cotton Blossom Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 Ningbo Meiduo General Products Co., Ltd ALCOHOL 60 g/100g 22100-006_2922a287-cf69-4207-87c1-61cd12d4512d 22100-006 HUMAN PRESCRIPTION DRUG Healing Waters Violet Rose Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 Ningbo Meiduo General Products Co., Ltd ALCOHOL 60 g/100g 22100-007_9e20bee7-0480-40a3-b6b9-190360e5562f 22100-007 HUMAN PRESCRIPTION DRUG Healing Waters Sweet Pea Lily Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 Ningbo Meiduo General Products Co., Ltd ALCOHOL 60 g/100g 22100-014_a43668a5-02eb-42c4-aab0-ce54ec72a4be 22100-014 HUMAN OTC DRUG Healing Waters Clean Cotton Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20110407 OTC MONOGRAPH NOT FINAL part333E NINGBO MEIDUO GENERAL PRODUCTS CO., LTD ALCOHOL 62 g/100g 22100-015_5880e893-4641-4690-981c-f722ca8a9419 22100-015 HUMAN OTC DRUG Healing Waters Cucumber Melon Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20110507 OTC MONOGRAPH NOT FINAL part333E NINGBO MEIDUO GENERAL PRODUCTS CO., LTD ALCOHOL 62 g/100g 22100-016_a50664f7-474b-47e4-b437-d026c3d50e60 22100-016 HUMAN OTC DRUG Healing Waters Island Nectar Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20110507 OTC MONOGRAPH NOT FINAL part333E NINGBO MEIDUO GENERAL PRODUCTS CO., LTD ALCOHOL 62 g/100g 22100-017_1f047926-ed0f-46c5-afd7-41d6aad9f8f6 22100-017 HUMAN OTC DRUG Healing Waters Sweet Pea Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20110507 OTC MONOGRAPH NOT FINAL part333E NINGBO MEIDUO GENERAL PRODUCTS CO., LTD ALCOHOL 62 g/100g 22100-020_336dbb3c-6980-4614-9a66-821b0615ac84 22100-020 HUMAN OTC DRUG Sweet Pea Waterless Anti-Antibateria Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110407 OTC MONOGRAPH NOT FINAL part333E NINGBO MEIDUO GENERAL PRODUCTS CO., LTD ALCOHOL 62 g/100g 22100-021_de32610a-5b5c-4ec6-b44e-205980fdf206 22100-021 HUMAN OTC DRUG Fresh Lavender Waterless Anti-Antibateria Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110418 OTC MONOGRAPH NOT FINAL part333E NINGBO MEIDUO GENERAL PRODUCTS CO., LTD ALCOHOL 62 g/100g 22100-022_6f1c4f48-3aac-4651-9f71-93b229124f6d 22100-022 HUMAN OTC DRUG Cotton Blossom Waterless Anti-Antibateria Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part333E NINGBO MEIDUO GENERAL PRODUCTS CO., LTD ALCOHOL 62 g/100g 22100-023_01cd56a7-d2f7-4d15-858e-569679b08e40 22100-023 HUMAN OTC DRUG Cherry Blossom Waterless Anti-Antibateria Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110407 OTC MONOGRAPH NOT FINAL part333E NINGBO MEIDUO GENERAL PRODUCTS CO., LTD ALCOHOL 62 g/100g 22201-1001_ce94e0ae-7ad7-49cf-b1c3-0299d8e9a9c4 22201-1001 HUMAN OTC DRUG Charmzone Natural Skinade BB Cream (SPF20 PA) TITANIUM DIOXIDE ZINC OXIDE CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part352 CHARMZONE CO LTD TITANIUM DIOXIDE; ZINC OXIDE 3.11; .777 mL/50mL; mL/50mL 22201-2001_5d7f20ed-e64b-4c80-8695-e27eeaa0c533 22201-2001 HUMAN OTC DRUG Charmzone ALBATROSS Powder Sun (SPF41 PA) OCTINOXATE OCTISALATE ZINC OXIDE TITANIUM DIOXIDE CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part352 CHARMZONE CO LTD OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 4.91; 3.15; 1.225; 2.33 mL/70mL; mL/70mL; mL/70mL; mL/70mL 22201-3001_b840d9bc-0eb0-48c8-a387-180e18769754 22201-3001 HUMAN OTC DRUG Charmzone Natural Skinade BB Cream (SPF20 PA) TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part352 CHARMZONE CO LTD TITANIUM DIOXIDE; ZINC OXIDE 3.11; .777 mL/50mL; mL/50mL 22408-000_0d9c3793-0976-42de-bea4-13fd06867737 22408-000 HUMAN OTC DRUG SUKANG Alcohol Prep Pads Medium ALCOHOL LIQUID TOPICAL 20130213 OTC MONOGRAPH FINAL part333E Taizhou Kanglin Health Protection Products Co Ltd ALCOHOL 70 g/100g 22408-001_8b7de57c-cb56-4d79-b39b-6b27b845e14f 22408-001 HUMAN OTC DRUG SUKANG BZK Antiseptic Towelette BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130213 OTC MONOGRAPH FINAL part333E Taizhou Kanglin Health Protection Products Co Ltd BENZALKONIUM CHLORIDE .13 g/100g 22431-100_68dc6a04-caff-4e6d-8d00-e8f4a96261c6 22431-100 HUMAN OTC DRUG Silk Antibacterial Foaming Hand Fresh Pear Triclosan LIQUID TOPICAL 20130603 OTC MONOGRAPH NOT FINAL part333A Blue Cross Laboratories, Inc. TRICLOSAN .46 mg/mL 22431-110_0ebf56f3-11f2-482e-8077-093ecef18dd8 22431-110 HUMAN OTC DRUG SILK ANTIBACTERIAL FOAMING HAND KITCHEN CITRUS benzalkonium Chloride LIQUID TOPICAL 20131207 OTC MONOGRAPH NOT FINAL part333A Blue Cross Laboratories, Inc. BENZALKONIUM CHLORIDE 1 mg/mL 22431-111_6ff08068-2e27-43ca-b148-65721dd5cc2e 22431-111 HUMAN OTC DRUG Blue Cross Laboratories Hand Rx Ethyl Alcohol LIQUID TOPICAL 20090501 OTC MONOGRAPH NOT FINAL part333E Blue Cross Laboratories ALCOHOL 62 mL/100mL 22431-112_67d529e2-b43c-4b1d-9330-b9c3caaae0c0 22431-112 HUMAN OTC DRUG Acne Treatment Kit Prescription Care Benzoyl Peroxide KIT 20091101 OTC MONOGRAPH FINAL part333D Blue Cross Laboratories 22431-124_75508b77-da85-4f33-b2a9-07c1b401e000 22431-124 HUMAN OTC DRUG Epsom Salts Relief Magnesium Sulfate Heptahydrate GRANULE ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Blue Cross Laboratories, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 100 g/100g 22431-125_5082eb7e-afcf-44da-846c-a018544262d1 22431-125 HUMAN OTC DRUG Med Aid Chest Rub Menthol,Camphor, Eucalyptus Oil OINTMENT TOPICAL 20120330 OTC MONOGRAPH NOT FINAL part348 Blue Cross Laboratories, Inc. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.7; 1.2; 1 g/100g; g/100g; g/100g 22431-126_f0bdf22c-ac55-4ef5-a526-b65870049dc2 22431-126 HUMAN OTC DRUG Med Aid Chest Rub Menthol,Camphor, Eucalyptus Oil OINTMENT TOPICAL 20120330 OTC MONOGRAPH NOT FINAL part348 Blue Cross Laboratories, Inc. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.7; 1; 1 g/100g; g/100g; g/100g 22431-127_078849a2-24cf-43b6-8973-dd1f759ac17b 22431-127 HUMAN OTC DRUG Silk Antibacterial Foaming Hand Triclosan SOAP TOPICAL 20130322 OTC MONOGRAPH NOT FINAL part333A Blue Cross Laboratories, Inc. TRICLOSAN .46 g/100mL 22431-128_078849a2-24cf-43b6-8973-dd1f759ac17b 22431-128 HUMAN OTC DRUG Fresh PearSilk Antibacterial Foaming Hand Triclosan SOAP TOPICAL 20130322 OTC MONOGRAPH NOT FINAL part333A Blue Cross Laboratories, Inc. TRICLOSAN .46 g/100mL 22431-130_bfe34238-7016-47b5-857b-97e8ce435d01 22431-130 HUMAN OTC DRUG Assured Vaporizing Chest Rub Menthol, Camphor, Eucalyptus Oil OINTMENT TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part348 Blue Cross Laboratories, Inc. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.7; 1; 1 g/100g; g/100g; g/100g 22431-132_9be4a43c-6047-4763-8fa4-a947001b5e7c 22431-132 HUMAN OTC DRUG Hand Sanitizer Lemon Scent Hand Rx Ethyl Alcohol GEL TOPICAL 20140819 OTC MONOGRAPH NOT FINAL part333E Blue Cross Laboratories, Inc. ALCOHOL 62 g/100mL 22431-200_8a7cfdf7-d6e4-4fc0-88ca-7b82093be847 22431-200 HUMAN OTC DRUG Marvel The Avengers Hand Sanitizer Alcohol GEL TOPICAL 20120725 OTC MONOGRAPH FINAL part333E Blue Cross Laboratories, Inc. ALCOHOL 62 mL/100mL 22431-210_e0d1028f-fde7-4b10-8f0a-d811ca9f605e 22431-210 HUMAN OTC DRUG Marvel Iron Man 3 Hand Sanitizer Alcohol GEL TOPICAL 20130104 OTC MONOGRAPH FINAL part333E Blue Cross Laboratories, Inc. ALCOHOL 62 mL/100mL 22431-220_3917c640-4882-4abe-b554-330ebd2eb855 22431-220 HUMAN OTC DRUG Silk Antibacterial Foaming Hand Original Triclosan LIQUID TOPICAL 20130322 OTC MONOGRAPH NOT FINAL part333A Blue Cross Laboratories, Inc. TRICLOSAN .46 mg/mL 22431-328_d9823d03-31e9-4d16-874d-81669bfda604 22431-328 HUMAN OTC DRUG Body Guard Sport Clear Aluminum Zirconium STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Blue Cross Laboratories ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 70 g/100g 22431-359_bf65f241-fd3a-4c29-951e-9fa7c82e3a62 22431-359 HUMAN OTC DRUG Relief Soothing Bath Treatment Colloidal Oatmeal GRANULE, EFFERVESCENT TOPICAL 20100917 OTC MONOGRAPH FINAL part347 Blue Cross Laboratories, Inc. OATMEAL 1 g/g 22431-525_b61d9048-8d90-4a79-803a-49c240729461 22431-525 HUMAN OTC DRUG Kitchen Citrus foaming hand Triclosan SOLUTION TOPICAL 20110722 OTC MONOGRAPH FINAL part333A Blue Cross Laboratories, Inc. TRICLOSAN .46 mL/100mL 22431-526_a76281ae-f505-44a9-be99-a44278ca8f94 22431-526 HUMAN OTC DRUG Original Antibacterial foaming hand Source Triclosan SOAP TOPICAL 20110722 OTC MONOGRAPH NOT FINAL part333A Blue Cross Laboratories, Inc. TRICLOSAN .46 g/100mL 22431-527_02d480a5-bfc1-4f2c-a8de-460281109d45 22431-527 HUMAN OTC DRUG Cool Plum Antibacterial foaming hand Triclosan SOLUTION TOPICAL 20110722 OTC MONOGRAPH NOT FINAL part333A Blue Cross Laboratories, Inc. TRICLOSAN .46 mL/100mL 22431-528_8b4f2bbe-ce61-45c5-9291-63de01171601 22431-528 HUMAN OTC DRUG Fresh Pear Foaming hand Triclosan SOLUTION TOPICAL 20110723 OTC MONOGRAPH NOT FINAL part333A Blue Cross Laboratories, Inc. TRICLOSAN .46 mL/100mL 22431-529_efdea9d4-ec2c-4860-a3e9-77dd39e3a9b2 22431-529 HUMAN OTC DRUG Original Antibacterial Foaming hand Triclosan SOLUTION TOPICAL 20110722 OTC MONOGRAPH NOT FINAL part333A Blue Cross Laboratories, Inc. TRICLOSAN .46 mL/100mL 22431-576_de97cd98-892c-44e9-b2c2-ca593876df78 22431-576 HUMAN OTC DRUG Athletes Foot Spray Dr. Foot Tolnaftate AEROSOL TOPICAL 20101019 OTC MONOGRAPH FINAL part333C Blue Cross Laboratories TOLNAFTATE 1 g/100g 22431-580_ae8accc4-edb4-40c9-9b32-d19b2cb816ad 22431-580 HUMAN OTC DRUG Dry Scalp Care Dandruff MD Pyrithizone Zinc SHAMPOO TOPICAL 20110127 OTC MONOGRAPH NOT FINAL part358H Blue Coss Laboratories, Inc. PYRITHIONE ZINC 1 mL/100mL 22431-581_8c67031f-9c09-40c9-bbe4-249c369f2772 22431-581 HUMAN OTC DRUG Hand Sanitizer Hand Rx Ethyl Alcohol LIQUID TOPICAL 20101012 OTC MONOGRAPH NOT FINAL part333E Blue Cross Laboratories, Inc. ALCOHOL 62 g/100mL 22431-582_5f433da3-c06d-43d0-94c2-c71b36e607ba 22431-582 HUMAN OTC DRUG Clear Antibacterial Hand Triclosan LIQUID TOPICAL 20140925 OTC MONOGRAPH NOT FINAL part333A Blue Cross Laboratories, Inc TRICLOSAN .15 g/100mL 22431-583_94160a7a-c6bf-4f33-8403-16373f008bfb 22431-583 HUMAN OTC DRUG Gold Antibacterial Hand Safety triclosan LIQUID TOPICAL 20140925 OTC MONOGRAPH NOT FINAL part333A Blue Cross Laboratories, Inc TRICLOSAN .15 g/100mL 22431-640_af87fe26-e3df-4c1b-8f7e-815d15f18402 22431-640 HUMAN OTC DRUG Antiperspirant Maximum Security Aluminum Zirconium tetrachlorohydrex STICK TOPICAL 20110607 OTC MONOGRAPH FINAL part350 Blue Cross Labs ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 6.02 g/70g 22557-001_980d8c14-b4ae-4949-b2f7-cdeca9a7ea69 22557-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20020101 UNAPPROVED MEDICAL GAS AGP LLC OXYGEN 99 L/100L 22557-002_d0a57b09-37d7-4c64-a358-71acedbb4938 22557-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20020101 UNAPPROVED MEDICAL GAS AGP LLC NITROGEN 99 L/100L 22577-070_f4193af6-47d2-4cca-b55c-7f231b7c6c08 22577-070 HUMAN OTC DRUG AVOBENZONE, OCTINOXATE, TITANIUM DIOXIDE AVOBENZONE, OCTINOXATE, TITANIUM DIOXIDE LIPSTICK TOPICAL 20100223 OTC MONOGRAPH NOT FINAL part352 GRAFTON PRODUCTS CORP. AVOBENZONE; OCTINOXATE; TITANIUM DIOXIDE .048; .192; .041 g/3.2g; g/3.2g; g/3.2g 22700-084_c900e3ab-7adc-4acb-8ec5-167db4f03658 22700-084 HUMAN OTC DRUG Covergirl Aquasmooth Broadspectrum SPF 20 All shades Titanium Dioxide CREAM TOPICAL 20140315 OTC MONOGRAPH NOT FINAL part352 Noxell Corporation TITANIUM DIOXIDE 9 g/100g 22700-098_8c47f3d4-03bc-479a-b713-9e24329b5582 22700-098 HUMAN OTC DRUG Covergirl Advanced Radiance Age Defying Makeup plus Sunscreen SPF 10 (All shades) Octinoxate and Titanium Dioxide LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Noxell OCTINOXATE; TITANIUM DIOXIDE 20; 50 mg/mL; mg/mL 22700-111_e0f5769d-730b-4769-9611-a9946163276b 22700-111 HUMAN OTC DRUG Covergirl plus Olay SimplyAgeless Foundation Broadspectrum SPF 22 (All shades) Titanium Dioxide CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Noxell TITANIUM DIOXIDE 49 mg/g 22700-127_eddb3f5a-92aa-412b-800e-8038f796f011 22700-127 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 805 Ivory Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-128_eddb3f5a-92aa-412b-800e-8038f796f011 22700-128 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 810 Classic Ivory Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-129_eddb3f5a-92aa-412b-800e-8038f796f011 22700-129 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 820 Creamy Natural Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-130_eddb3f5a-92aa-412b-800e-8038f796f011 22700-130 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 825 Buff Beige Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-131_eddb3f5a-92aa-412b-800e-8038f796f011 22700-131 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 832 Nude Beige Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-132_eddb3f5a-92aa-412b-800e-8038f796f011 22700-132 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 840 Natural Beige Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-133_eddb3f5a-92aa-412b-800e-8038f796f011 22700-133 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 842 Medium Beige Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-134_eddb3f5a-92aa-412b-800e-8038f796f011 22700-134 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 845 Warm Beige Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-135_eddb3f5a-92aa-412b-800e-8038f796f011 22700-135 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 850 Creamy Beige Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-136_eddb3f5a-92aa-412b-800e-8038f796f011 22700-136 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 855 Soft Honey Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-137_eddb3f5a-92aa-412b-800e-8038f796f011 22700-137 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 857 Golden Tan Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-138_eddb3f5a-92aa-412b-800e-8038f796f011 22700-138 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 860 Classic Tan Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-139_eddb3f5a-92aa-412b-800e-8038f796f011 22700-139 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 865 Tawny Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-140_eddb3f5a-92aa-412b-800e-8038f796f011 22700-140 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 875 Soft Sable Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-141_8953e3b3-6cb3-4483-b1ae-3804ba53aec5 22700-141 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q800 Sand Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-142_8953e3b3-6cb3-4483-b1ae-3804ba53aec5 22700-142 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q805 Amber Glow Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-143_8953e3b3-6cb3-4483-b1ae-3804ba53aec5 22700-143 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q810 Classic Bronze Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-144_8953e3b3-6cb3-4483-b1ae-3804ba53aec5 22700-144 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q815 Brulee Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-145_8953e3b3-6cb3-4483-b1ae-3804ba53aec5 22700-145 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q820 Toffee Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-146_8953e3b3-6cb3-4483-b1ae-3804ba53aec5 22700-146 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q825 Golden Honey Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-147_8953e3b3-6cb3-4483-b1ae-3804ba53aec5 22700-147 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q830 Soft Copper Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-148_8953e3b3-6cb3-4483-b1ae-3804ba53aec5 22700-148 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q835 Mocha Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-149_8953e3b3-6cb3-4483-b1ae-3804ba53aec5 22700-149 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q840 Almond Glow Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-150_8953e3b3-6cb3-4483-b1ae-3804ba53aec5 22700-150 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q845 Warm Caramel Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-151_8953e3b3-6cb3-4483-b1ae-3804ba53aec5 22700-151 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q850 Sheer Espresso Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-152_8953e3b3-6cb3-4483-b1ae-3804ba53aec5 22700-152 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q855 Spicy Brown Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-153_8953e3b3-6cb3-4483-b1ae-3804ba53aec5 22700-153 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q860 Rich Mink Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22700-154_8953e3b3-6cb3-4483-b1ae-3804ba53aec5 22700-154 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q865 True Ebony Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL 22840-0033_e1d71870-b466-498d-8e9f-292f060d1a92 22840-0033 HUMAN PRESCRIPTION DRUG Allergenic Extracts Standardized Mite Dermatophagoides farinae CONCENTRATE INTRADERMAL; SUBCUTANEOUS 20100203 BLA BLA101834 Greer Laboratories, Inc. DERMATOPHAGOIDES FARINAE 5000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 22840-0034_e1d71870-b466-498d-8e9f-292f060d1a92 22840-0034 HUMAN PRESCRIPTION DRUG Allergenic Extracts Standardized Mite Dermatophagoides farinae CONCENTRATE INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 20100203 BLA BLA101834 Greer Laboratories, Inc. DERMATOPHAGOIDES FARINAE 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 22840-0035_e1d71870-b466-498d-8e9f-292f060d1a92 22840-0035 HUMAN PRESCRIPTION DRUG Allergenic Extracts Standardized Mite Dermatophagoides pteronyssinus CONCENTRATE INTRADERMAL; SUBCUTANEOUS 20100203 BLA BLA101835 Greer Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 5000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 22840-0036_e1d71870-b466-498d-8e9f-292f060d1a92 22840-0036 HUMAN PRESCRIPTION DRUG Allergenic Extracts Standardized Mite Dermatophagoides pteronyssinus CONCENTRATE INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 20100203 BLA BLA101835 Greer Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 22840-0037_e1d71870-b466-498d-8e9f-292f060d1a92 22840-0037 HUMAN PRESCRIPTION DRUG Allergenic Extracts Standardized Mite Dermatophagoides farinae and Dermatophagoides pteronyssinus CONCENTRATE INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 20100203 BLA BLA101834 Greer Laboratories, Inc. DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 5000; 5000 [AU]/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 22840-0038_e1d71870-b466-498d-8e9f-292f060d1a92 22840-0038 HUMAN PRESCRIPTION DRUG Allergenic Extracts Standardized Mite Dermatophagoides farinae CONCENTRATE INTRADERMAL; SUBCUTANEOUS 20100203 BLA BLA101834 Greer Laboratories, Inc. DERMATOPHAGOIDES FARINAE 30000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 22840-0039_e1d71870-b466-498d-8e9f-292f060d1a92 22840-0039 HUMAN PRESCRIPTION DRUG Allergenic Extracts Standardized Mite Dermatophagoides pteronyssinus CONCENTRATE INTRADERMAL; SUBCUTANEOUS 20100203 BLA BLA101835 Greer Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 30000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 22840-0040_e1d71870-b466-498d-8e9f-292f060d1a92 22840-0040 HUMAN PRESCRIPTION DRUG Allergenic Extracts Standardized Mite Dermatophagoides farinae and Dermatophagoides pteronyssinus CONCENTRATE INTRADERMAL; SUBCUTANEOUS 20100203 BLA BLA101834 Greer Laboratories, Inc. DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 15000; 15000 [AU]/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 22884-8103_0332777c-331c-4cfe-b220-6f7315172528 22884-8103 HUMAN OTC DRUG Pre-Scrub II Surgical Hand Scrub Chlorhexidine Gluconate Solution SOLUTION TOPICAL 19890301 NDA NDA019822 BioMed Systems, Inc. CHLORHEXIDINE GLUCONATE 1 mg/25mL 22912-000_7f6aef7b-0cb3-4b3f-b148-1856f460b44d 22912-000 HUMAN OTC DRUG fluorodine OXYGEN white Fluoride Anticavity SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130327 OTC MONOGRAPH FINAL part355 Multibrands International Ltd SODIUM FLUORIDE .24 g/100g 22912-001_6a229faf-a04e-4e81-94db-32060aa434a7 22912-001 HUMAN OTC DRUG fluorodine ACTIVE fresh Fluoride Anticavity SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20130327 OTC MONOGRAPH FINAL part355 Multibrands International Ltd SODIUM MONOFLUOROPHOSPHATE .8 g/100g 22912-002_43ed8cd7-183a-480f-ac2d-467fd33c68d9 22912-002 HUMAN OTC DRUG fluorodine ULTRA active Fluoride Anticavity SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130327 OTC MONOGRAPH FINAL part355 Multibrands International Ltd SODIUM FLUORIDE .24 g/100g 22912-003_ac4c90fd-282a-4c05-92fb-dae549777fd8 22912-003 HUMAN OTC DRUG fluorodine ULTRA sensitive Fluoride Anticavity POTASSIUM NITRATE, SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130410 OTC MONOGRAPH NOT FINAL part356 Multibrands International Ltd POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 22955-012_93390d23-4701-4bcb-8e8a-1abb507368a7 22955-012 HUMAN OTC DRUG Allergy Buster Capsicum annuum, Urtica dioica SPRAY NASAL 20081231 UNAPPROVED HOMEOPATHIC SiCap Industries LLC RED PEPPER; URTICA DIOICA 5; 3 [hp_X]/20mL; [hp_X]/20mL 22955-013_7be3b9f3-22c4-460d-82ec-cac81980a20f 22955-013 HUMAN OTC DRUG Headache Buster Capsicum annuum, pyrethrum parthenium, mentholum SPRAY NASAL 20081231 UNAPPROVED HOMEOPATHIC SiCap Industries LLC MENTHOL; RED PEPPER; TANACETUM PARTHENIUM 2; 4; 3 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL 22955-014_de4d75dd-fff7-47ff-ba87-a3362f6200c4 22955-014 HUMAN OTC DRUG Sinus Buster Capsicum Annuum SPRAY NASAL 20081231 UNAPPROVED HOMEOPATHIC SiCap Industries LLC RED PEPPER 4 [hp_X]/20mL 22955-015_ad41861c-360a-495d-8993-c3ae590c98e3 22955-015 HUMAN OTC DRUG Sinus Buster Mild Formula Capsicum Annuum SPRAY NASAL 20081231 UNAPPROVED HOMEOPATHIC SiCap Industries LLC RED PEPPER 5 [hp_X]/20mL 22955-016_40c0a800-3c47-4b8c-9ad1-6e4dbca51a1b 22955-016 HUMAN OTC DRUG Cold Buster Pelargonium sidoides SYRUP ORAL 20100701 UNAPPROVED HOMEOPATHIC SiCap Industries LLC PELARGONIUM SIDOIDES ROOT 24 [hp_X]/120mL 23021-001_413ca6ab-9c16-4bc3-9e27-375431ee830a 23021-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19460101 UNAPPROVED MEDICAL GAS Cranston Welding Supply Company OXYGEN 99 L/100L 23104-5010_a091b036-988a-4170-a21d-6c003b5b1519 23104-5010 HUMAN OTC DRUG Becca Mineral SPF Primer Zinc Oxide CREAM TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part352 Cosmetic Developments Limited ZINC OXIDE 17 mL/100mL 23155-001_a9cb621b-ec44-49cb-abea-d4e162e66b04 23155-001 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Heritage Pharmaceuticals Inc HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 23155-002_a9cb621b-ec44-49cb-abea-d4e162e66b04 23155-002 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Heritage Pharmaceuticals Inc HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 23155-003_a9cb621b-ec44-49cb-abea-d4e162e66b04 23155-003 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Heritage Pharmaceuticals Inc HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 23155-004_a9cb621b-ec44-49cb-abea-d4e162e66b04 23155-004 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Heritage Pharmaceuticals Inc HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 23155-005_d1496e17-f164-4f85-8242-5ff772d25cdb 23155-005 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20070716 ANDA ANDA073262 Heritage Pharmaceuticals Inc. SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 23155-006_d1496e17-f164-4f85-8242-5ff772d25cdb 23155-006 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20070716 ANDA ANDA073262 Heritage Pharmaceuticals Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 23155-010_c0ed1c71-4f79-4f1b-bb1d-32ca7d88ed93 23155-010 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20100730 NDA NDA018851 Heritage Pharmaceuticals Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 23155-011_c0ed1c71-4f79-4f1b-bb1d-32ca7d88ed93 23155-011 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20100730 NDA NDA018851 Heritage Pharmaceuticals Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 23155-012_7aed9756-62e2-49c9-a9e7-f6ffe86ff77f 23155-012 HUMAN PRESCRIPTION DRUG PROPOXYPHENE HYDROCHLORIDE propoxyphene hydrochloride CAPSULE ORAL 20090501 ANDA ANDA080530 Heritage Pharmaceuticals Inc PROPOXYPHENE HYDROCHLORIDE 65 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 23155-013_47fae28b-5ae6-4604-9962-a8bf4f9f9584 23155-013 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20101105 ANDA ANDA040275 Heritage Pharmaceuticals Inc ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 23155-014_47fae28b-5ae6-4604-9962-a8bf4f9f9584 23155-014 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20101105 ANDA ANDA040275 Heritage Pharmaceuticals Inc ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 23155-015_47fae28b-5ae6-4604-9962-a8bf4f9f9584 23155-015 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20101105 ANDA ANDA040275 Heritage Pharmaceuticals Inc ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 23155-017_b0a746d7-6227-435e-b4bf-78f12dade4a3 23155-017 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20131018 NDA NDA050278 Heritage Pharmaceuticals Inc. TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 23155-018_b0a746d7-6227-435e-b4bf-78f12dade4a3 23155-018 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20131018 NDA NDA050278 Heritage Pharmaceuticals Inc. TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 23155-026_36cbe56e-137d-4b69-a735-73ebaff57fcf 23155-026 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET ORAL 20110107 ANDA ANDA071880 Heritage Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 23155-027_b9feb7c5-4296-444e-9107-6d0e443f187d 23155-027 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET ORAL 20110107 ANDA ANDA071881 Heritage Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 23155-028_b195afa2-1728-44cf-8f69-6bba7808849a 23155-028 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20120629 ANDA ANDA201336 Heritage Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 23155-029_b195afa2-1728-44cf-8f69-6bba7808849a 23155-029 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20120629 ANDA ANDA201336 Heritage Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 23155-030_b195afa2-1728-44cf-8f69-6bba7808849a 23155-030 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20120629 ANDA ANDA201336 Heritage Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 23155-035_bdbbb1d1-aaf6-4e36-8754-f5757b31303d 23155-035 HUMAN PRESCRIPTION DRUG Moexipril hydrochloride and hydrochlorothiazide Moexipril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20140320 ANDA ANDA202150 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5; 7.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 23155-036_bdbbb1d1-aaf6-4e36-8754-f5757b31303d 23155-036 HUMAN PRESCRIPTION DRUG Moexipril hydrochloride and hydrochlorothiazide Moexipril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20140320 ANDA ANDA202150 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5; 15 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 23155-037_bdbbb1d1-aaf6-4e36-8754-f5757b31303d 23155-037 HUMAN PRESCRIPTION DRUG Moexipril hydrochloride and hydrochlorothiazide Moexipril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20140320 ANDA ANDA202150 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 25; 15 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 23155-038_972af693-5b2f-484a-9398-8fd20ade3b43 23155-038 HUMAN PRESCRIPTION DRUG Paromomycin Sulfate Paromomycin Sulfate CAPSULE ORAL 20091022 ANDA ANDA065173 Heritage Pharmaceuticals Inc. PAROMOMYCIN SULFATE 250 mg/1 Antiprotozoal [EPC] 23155-043_03ab0fd4-fe51-4279-b5f6-437ef3808c17 23155-043 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20091029 ANDA ANDA077086 Heritage Pharmaceuticals Inc LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] 23155-044_03ab0fd4-fe51-4279-b5f6-437ef3808c17 23155-044 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20091029 ANDA ANDA077086 Heritage Pharmaceuticals Inc LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] 23155-045_25cd9999-b321-4ffc-8f40-558a72d346b4 23155-045 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20101210 ANDA ANDA079237 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 23155-046_b13d4f4a-b95a-4593-8a80-953da1df1c56 23155-046 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100820 ANDA ANDA040807 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 23155-046_d2805216-a90f-4695-8597-fdbf92f2d667 23155-046 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110103 ANDA ANDA040807 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 23155-047_b13d4f4a-b95a-4593-8a80-953da1df1c56 23155-047 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100820 ANDA ANDA040807 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 23155-047_d2805216-a90f-4695-8597-fdbf92f2d667 23155-047 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110103 ANDA ANDA040807 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 23155-048_05583d58-4f72-4598-a686-3373adaae684 23155-048 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20131108 ANDA ANDA201964 HERITAGE PHARMACEUTICALS INC. FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 23155-049_05583d58-4f72-4598-a686-3373adaae684 23155-049 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20131108 ANDA ANDA201964 HERITAGE PHARMACEUTICALS INC. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 23155-050_05583d58-4f72-4598-a686-3373adaae684 23155-050 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20131108 ANDA ANDA201964 HERITAGE PHARMACEUTICALS INC. FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 23155-051_1348d536-cda5-4a9c-af6a-30ce64a5714f 23155-051 HUMAN PRESCRIPTION DRUG Nystatin Nystatin TABLET, COATED ORAL 20111031 ANDA ANDA062474 Heritage Pharmaceuticals Inc NYSTATIN 500000 [USP'U]/1 Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 23155-054_844387f0-c48c-4302-8626-0a12bba8fe33 23155-054 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET ORAL 20110315 ANDA ANDA200502 Heritage Pharmaceuticals Inc. NARATRIPTAN HYDROCHLORIDE 1 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 23155-055_844387f0-c48c-4302-8626-0a12bba8fe33 23155-055 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET ORAL 20110315 ANDA ANDA200502 Heritage Pharmaceuticals Inc. NARATRIPTAN HYDROCHLORIDE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 23155-056_a2b88dfa-82ef-4dc4-a049-6bce779a97cc 23155-056 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Heritage Pharmaceuticals Inc. GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 23155-057_a2b88dfa-82ef-4dc4-a049-6bce779a97cc 23155-057 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Heritage Pharmaceuticals Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 23155-058_a2b88dfa-82ef-4dc4-a049-6bce779a97cc 23155-058 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Heritage Pharmaceuticals Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 23155-060_199837fb-147b-4251-a0db-08220c0d9045 23155-060 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide Tablet TABLET ORAL 20111115 ANDA ANDA079025 Heritage Pharmaceuticals Inc. FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 23155-061_199837fb-147b-4251-a0db-08220c0d9045 23155-061 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20111115 ANDA ANDA079025 Heritage Pharmaceuticals Inc. FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 23155-062_42959559-2e03-4f3e-970b-bbc9c913a510 23155-062 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20101101 ANDA ANDA090430 Heritage Pharmaceuticals Inc. THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 23155-063_42959559-2e03-4f3e-970b-bbc9c913a510 23155-063 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20101101 ANDA ANDA090430 Heritage Pharmaceuticals Inc. THEOPHYLLINE ANHYDROUS 450 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 23155-064_9f40dc3b-a2ee-4a9d-be70-a88704069795 23155-064 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20131216 ANDA ANDA079067 Heritage Pharmaceuticals Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 23155-065_9f40dc3b-a2ee-4a9d-be70-a88704069795 23155-065 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20131216 ANDA ANDA079067 Heritage Pharmaceuticals Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 23155-066_739b089d-7fba-414f-8b0e-8bda890bc780 23155-066 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole CAPSULE ORAL 20110823 ANDA ANDA079065 Heritage Pharmaceuticals Inc. METRONIDAZOLE 375 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 23155-070_79f901cb-fc24-4677-b4c8-827369a29a44 23155-070 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20120116 ANDA ANDA040734 Heritage Pharmaceuticals Inc. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 23155-071_79f901cb-fc24-4677-b4c8-827369a29a44 23155-071 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20120116 ANDA ANDA040734 Heritage Pharmaceuticals Inc. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 23155-102_79cc3a62-00ce-4b25-a91a-6b6256092f80 23155-102 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Heritage Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 23155-103_79cc3a62-00ce-4b25-a91a-6b6256092f80 23155-103 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Heritage Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 23155-104_79cc3a62-00ce-4b25-a91a-6b6256092f80 23155-104 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Heritage Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 23155-105_31945055-e1c9-4ecd-9ab0-944a377beefb 23155-105 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Heritage Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 23155-106_31945055-e1c9-4ecd-9ab0-944a377beefb 23155-106 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Heritage Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 23155-107_31945055-e1c9-4ecd-9ab0-944a377beefb 23155-107 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Heritage Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 23155-108_6fb8ce9c-b4b6-4672-ae31-f6aff6e92447 23155-108 HUMAN PRESCRIPTION DRUG Nimodipine Nimodipine CAPSULE, LIQUID FILLED ORAL 20080321 ANDA ANDA076740 Heritage NIMODIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 23155-110_a33756cb-a113-4488-be81-2e76c7edc990 23155-110 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Heritage Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 23155-111_a33756cb-a113-4488-be81-2e76c7edc990 23155-111 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Heritage Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 23155-112_a33756cb-a113-4488-be81-2e76c7edc990 23155-112 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Heritage Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 23155-113_a33756cb-a113-4488-be81-2e76c7edc990 23155-113 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Heritage Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 23155-114_a33756cb-a113-4488-be81-2e76c7edc990 23155-114 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Heritage Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 23155-115_dad84389-2bf4-493b-8c20-6e36822f08ff 23155-115 HUMAN PRESCRIPTION DRUG Glipizide and Metformin HCl Glipizide and Metformin HCl TABLET, FILM COATED ORAL 20100629 ANDA ANDA078728 Heritage Pharmaceuticals Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 23155-116_dad84389-2bf4-493b-8c20-6e36822f08ff 23155-116 HUMAN PRESCRIPTION DRUG Glipizide and Metformin HCl Glipizide and Metformin HCl TABLET, FILM COATED ORAL 20100629 ANDA ANDA078728 Heritage Pharmaceuticals Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 23155-117_dad84389-2bf4-493b-8c20-6e36822f08ff 23155-117 HUMAN PRESCRIPTION DRUG Glipizide and Metformin HCl Glipizide and Metformin HCl TABLET, FILM COATED ORAL 20100629 ANDA ANDA078728 Heritage Pharmaceuticals Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 23155-118_2000f2f6-7c00-44f8-8eb5-b7151f268c1e 23155-118 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20130529 ANDA ANDA091174 Heritage Pharmaceuticals Inc CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 23155-119_2000f2f6-7c00-44f8-8eb5-b7151f268c1e 23155-119 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20130529 ANDA ANDA091174 Heritage Pharmaceuticals Inc CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 23155-120_71815e45-cb2c-4c4a-a6a0-fabaf36fdf83 23155-120 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide CAPSULE, EXTENDED RELEASE ORAL 20120924 ANDA ANDA090779 Heritage Pharmaceuticals Inc. ACETAZOLAMIDE 500 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 23155-121_0655cf97-2f3a-482f-94bb-4a463ac78d00 23155-121 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090918 ANDA ANDA090429 Heritage Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 23155-122_0655cf97-2f3a-482f-94bb-4a463ac78d00 23155-122 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090918 ANDA ANDA090429 Heritage Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 23155-123_0655cf97-2f3a-482f-94bb-4a463ac78d00 23155-123 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090918 ANDA ANDA090429 Heritage Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 23155-124_0655cf97-2f3a-482f-94bb-4a463ac78d00 23155-124 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090918 ANDA ANDA090429 Heritage Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 23155-125_0655cf97-2f3a-482f-94bb-4a463ac78d00 23155-125 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090918 ANDA ANDA090429 Heritage Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 23155-126_0655cf97-2f3a-482f-94bb-4a463ac78d00 23155-126 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20091009 ANDA ANDA090429 Heritage Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 23155-127_0655cf97-2f3a-482f-94bb-4a463ac78d00 23155-127 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090918 ANDA ANDA090429 Heritage Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 23155-128_c269dbf3-174e-487c-aa5b-2397a4ad1b66 23155-128 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20090501 ANDA ANDA090122 Heritage Pharmaceuticals Inc. MEPROBAMATE 200 mg/1 CIV 23155-129_c269dbf3-174e-487c-aa5b-2397a4ad1b66 23155-129 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20090501 ANDA ANDA090122 Heritage Pharmaceuticals Inc. MEPROBAMATE 400 mg/1 CIV 23155-133_05330f77-aeec-4c2c-b491-5aa4bd9a6bd5 23155-133 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET ORAL 20120105 ANDA ANDA091605 Heritage Pharmaceuticals Inc. DOXYCYCLINE 50 mg/1 23155-134_05330f77-aeec-4c2c-b491-5aa4bd9a6bd5 23155-134 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET ORAL 20120105 ANDA ANDA091605 Heritage Pharmaceuticals Inc. DOXYCYCLINE 75 mg/1 23155-135_05330f77-aeec-4c2c-b491-5aa4bd9a6bd5 23155-135 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET ORAL 20120105 ANDA ANDA091605 Heritage Pharmaceuticals Inc. DOXYCYCLINE 100 mg/1 23155-136_05330f77-aeec-4c2c-b491-5aa4bd9a6bd5 23155-136 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET ORAL 20120105 ANDA ANDA091605 Heritage Pharmaceuticals Inc. DOXYCYCLINE 150 mg/1 23155-137_b13d4f4a-b95a-4593-8a80-953da1df1c56 23155-137 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20120629 ANDA ANDA040807 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 23155-137_d2805216-a90f-4695-8597-fdbf92f2d667 23155-137 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110103 ANDA ANDA040807 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 23155-140_7a24f8f1-17f8-493a-bede-37314c9681ee 23155-140 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20090620 ANDA ANDA079237 Heritage Pharmaceuticals Inc HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 23155-141_0448790e-176f-4255-bb0e-04247ce3d752 23155-141 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Delayed release Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20130430 ANDA ANDA200856 Heritage Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 75 mg/1 23155-142_0448790e-176f-4255-bb0e-04247ce3d752 23155-142 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Delayed release Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20130430 ANDA ANDA200856 Heritage Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 100 mg/1 23155-143_0448790e-176f-4255-bb0e-04247ce3d752 23155-143 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Delayed release Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20130430 ANDA ANDA200856 Heritage Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 150 mg/1 23155-145_6e7d3064-3529-419b-9ed7-ead7dea87a4d 23155-145 HUMAN PRESCRIPTION DRUG Carisoprodol and Aspirin Carisoprodol and Aspirin TABLET ORAL 20110331 ANDA ANDA089594 Heritage Pharmaceuticals Inc. ASPIRIN; CARISOPRODOL 325; 200 mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIV 23155-146_38c1be27-f2a5-4381-8f77-b25523b528fc 23155-146 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20100614 ANDA ANDA075090 Heritage Pharmaceuticals, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 23155-147_60cae181-74c3-4d05-957c-ab1a059d0a31 23155-147 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20120730 ANDA ANDA202271 Heritage Pharmaceuticals Inc. ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 23155-148_60cae181-74c3-4d05-957c-ab1a059d0a31 23155-148 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20120730 ANDA ANDA202271 Heritage Pharmaceuticals Inc. ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 23155-149_60cae181-74c3-4d05-957c-ab1a059d0a31 23155-149 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20120730 ANDA ANDA202271 Heritage Pharmaceuticals Inc. ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 23155-160_fe400c78-a237-491f-ba43-00558ed228e8 23155-160 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION INTRAVENOUS 20120913 ANDA ANDA204618 Heritage Pharmaceuticals Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 23155-162_4428abca-5543-4e4b-9ab5-7a73286b329c 23155-162 HUMAN PRESCRIPTION DRUG Ibandronate sodium Ibandronate sodium INJECTION, SOLUTION INTRAVENOUS 20140904 ANDA ANDA203987 Heritage Pharmaceuticals Inc. IBANDRONATE SODIUM 3 mg/3mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 23155-166_34dc7aca-284c-4cee-b7c0-4f229c57982e 23155-166 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20120220 ANDA ANDA203521 Heritage Pharmaceuticals Inc. TRANEXAMIC ACID 1 g/10mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 23155-168_07d72783-e20a-4f94-8afb-e3b7885757f7 23155-168 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20121213 ANDA ANDA090424 Heritage Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 23155-170_08b1af27-adf5-417f-b4f7-1893cf1da94a 23155-170 HUMAN PRESCRIPTION DRUG Zoledronic acid Zoledronic acid INJECTION, SOLUTION INTRAVENOUS 20121220 ANDA ANDA201783 Heritage Pharmaceuticals Inc. ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 23155-174_c8502841-19f1-4cc5-a0b8-44b82bb0636f 23155-174 HUMAN PRESCRIPTION DRUG Benzphetamine Hydrochloride Benzphetamine Hydrochloride Tablets TABLET, FILM COATED ORAL 20121019 ANDA ANDA202061 Heritage Pharmaceuticals Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 23155-178_48d6b7b9-a461-40c7-abed-f0ae7dd0c688 23155-178 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100607 ANDA ANDA075522 Heritage Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 23155-179_307c17d4-2970-414c-a350-c97bdd593229 23155-179 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION INTRAVENOUS 20120620 ANDA ANDA200771 Heritage Pharmaceuticals Inc. IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 23155-186_c9569d4b-9b50-493d-9612-6dcbe44e8a98 23155-186 HUMAN PRESCRIPTION DRUG Zoledronic acid Zoledronic acid INJECTION, SOLUTION INTRAVENOUS 20121220 ANDA ANDA201801 Heritage Pharmaceuticals Inc. ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 23155-193_e796635a-bfb7-4c8b-8a72-1e80c257c623 23155-193 HUMAN PRESCRIPTION DRUG COLISTIMETHATE SODIUM COLISTIMETHATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121022 ANDA ANDA202359 Heritage Pharmaceuticals Inc. COLISTIMETHATE SODIUM 150 mg/4mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 23155-194_3539e52f-e846-43be-8173-cf1855c908c4 23155-194 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE ORAL 20101207 ANDA ANDA202644 Heritage Pharmaceuticals Inc. NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 23155-195_3539e52f-e846-43be-8173-cf1855c908c4 23155-195 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE ORAL 20101207 ANDA ANDA202644 Heritage Pharmaceuticals Inc. NIFEDIPINE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 23155-196_0199971d-69fe-4bae-a775-ae135613ed94 23155-196 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130118 ANDA ANDA078945 Heritage Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 23155-201_106af010-acfe-4b5c-99ff-8b697aeefb91 23155-201 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION INTRAVENOUS 20130204 ANDA ANDA202590 Heritage Pharmaceuticals Inc. LEVOFLOXACIN 25 mg/mL 23155-213_fd53cdd4-5167-412d-8843-94b2a38b02cb 23155-213 HUMAN PRESCRIPTION DRUG Gemcitabine hydrochloride Gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20121022 ANDA ANDA202063 Heritage Pharmaceuticals Inc. GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 23155-214_fd53cdd4-5167-412d-8843-94b2a38b02cb 23155-214 HUMAN PRESCRIPTION DRUG Gemcitabine hydrochloride Gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20121022 ANDA ANDA202063 Heritage Pharmaceuticals Inc. GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 23155-216_494b7069-daf9-481c-b442-b926030f8922 23155-216 HUMAN PRESCRIPTION DRUG CIDOFOVIR DIHYDRATE CIDOFOVIR DIHYDRATE INJECTION, SOLUTION INTRAVENOUS 20120806 ANDA ANDA202501 Heritage Pharmaceuticals Inc. CIDOFOVIR 375 mg/5mL Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient] 23155-217_d6e66c8b-76bf-4cf9-a876-d2e200150e54 23155-217 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20131115 ANDA ANDA202275 Heritage Pharmaceuticals Inc. VANCOMYCIN HYDROCHLORIDE 500 mg/4mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 23155-218_d6e66c8b-76bf-4cf9-a876-d2e200150e54 23155-218 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20131115 ANDA ANDA202275 Heritage Pharmaceuticals Inc. VANCOMYCIN HYDROCHLORIDE 1 g/8mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 23155-219_d1fbba3e-fd74-43b9-8044-b3276155a0de 23155-219 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20111125 ANDA ANDA202274 Heritage Pharmaceuticals Inc. VANCOMYCIN HYDROCHLORIDE 5 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 23155-220_594beb1d-03cc-432e-ae7c-d497f800fb22 23155-220 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCLORIDE VANCOMYCIN HYDROCLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20111129 ANDA ANDA202464 Heritage Pharmaceuticals Inc. VANCOMYCIN HYDROCHLORIDE 10 g/80mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 23155-227_f8e46458-4b1e-409a-9b04-6770e8d85615 23155-227 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20130808 ANDA ANDA074891 Heritage Pharmaceuticals Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 23155-228_f8e46458-4b1e-409a-9b04-6770e8d85615 23155-228 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20130808 ANDA ANDA074891 Heritage Pharmaceuticals Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 23155-233_3e76c441-ae67-4f1a-b33c-33a47361624f 23155-233 HUMAN PRESCRIPTION DRUG Glyburide-Metformin Hydrochloride Glyburide-Metformin Hydrochloride TABLET ORAL 20121101 ANDA ANDA079009 Heritage Pharmaceuticals Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 23155-234_3e76c441-ae67-4f1a-b33c-33a47361624f 23155-234 HUMAN PRESCRIPTION DRUG Glyburide-Metformin Hydrochloride Glyburide-Metformin Hydrochloride TABLET ORAL 20121101 ANDA ANDA079009 Heritage Pharmaceuticals Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 23155-235_3e76c441-ae67-4f1a-b33c-33a47361624f 23155-235 HUMAN PRESCRIPTION DRUG Glyburide-Metformin Hydrochloride Glyburide-Metformin Hydrochloride TABLET ORAL 20121101 ANDA ANDA079009 Heritage Pharmaceuticals Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 23155-240_20cb4a6e-f10d-42c0-9678-0c0e7acd636b 23155-240 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20140103 ANDA ANDA204756 Heritage Pharmaceuticals Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 23155-244_b3c0bb9d-e752-4359-a35b-e1c0b22d15b2 23155-244 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20131212 ANDA ANDA204090 Heritage Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 23155-245_b3c0bb9d-e752-4359-a35b-e1c0b22d15b2 23155-245 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20131212 ANDA ANDA204090 Heritage Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 23155-246_a9f75664-c962-41d6-b809-bfab3ff84e0d 23155-246 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130 ANDA ANDA078554 Heritage Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 23155-247_a9f75664-c962-41d6-b809-bfab3ff84e0d 23155-247 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130 ANDA ANDA078554 Heritage Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 23155-248_a9f75664-c962-41d6-b809-bfab3ff84e0d 23155-248 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130 ANDA ANDA078554 Heritage Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 23155-249_a9f75664-c962-41d6-b809-bfab3ff84e0d 23155-249 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130 ANDA ANDA078554 Heritage Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 23155-250_a9f75664-c962-41d6-b809-bfab3ff84e0d 23155-250 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130 ANDA ANDA078554 Heritage Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 23155-258_7a61e785-f066-426f-a887-af42de97d22c 23155-258 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20140801 ANDA ANDA202313 Heritage Pharmaceuticals Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 23155-261_e06719b4-a3c1-476d-a116-491fad423f19 23155-261 HUMAN PRESCRIPTION DRUG BiCNU CARMUSTINE KIT 20130404 NDA NDA017422 Heritage Pharmaceuticals Inc. 23155-290_9de8bc80-6d7c-4cf6-ace4-55bd7a55e9ed 23155-290 HUMAN PRESCRIPTION DRUG Amikacin Sulfate Amikacin Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131224 ANDA ANDA204040 Heritage Pharmaceuticals Inc. AMIKACIN SULFATE 250 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 23155-291_6bf5f8d4-1a53-499c-8ef8-8b6c7383bc62 23155-291 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SYRUP ORAL 20130715 ANDA ANDA090102 Heritage Pharmaceuticals Inc. RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 23155-292_295bbe9d-c48e-49d2-b8ce-5ffae11e86eb 23155-292 HUMAN PRESCRIPTION DRUG Cetirizine hydrochloride Cetirizine hydrochloride SOLUTION ORAL 20090407 ANDA ANDA078870 Heritage Pharmaceuticals Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 23155-294_f76d41eb-11db-40f9-abd4-4021cf588e68 23155-294 HUMAN PRESCRIPTION DRUG Prochlorperazine Edisylate Prochlorperazine Edisylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20120326 ANDA ANDA204147 Heritage Pharmaceuticals Inc. PROCHLORPERAZINE EDISYLATE 5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 23155-313_396437d2-b2ca-4220-ba21-cb3616708cd4 23155-313 HUMAN PRESCRIPTION DRUG ACETAZOLAMIDE ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141219 ANDA ANDA202693 Heritage Pharmaceuticals Inc. ACETAZOLAMIDE SODIUM 500 mg/5mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 23155-317_ebef6e7d-e33d-403e-9433-3d4338814f18 23155-317 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20130715 ANDA ANDA078909 Heritage Pharmaceuticals Inc. RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] 23155-340_92333930-236b-4d9f-a3f4-277f1e6f8935 23155-340 HUMAN PRESCRIPTION DRUG Rifampin Rifampin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140818 ANDA ANDA204101 Heritage Pharmaceuticals Inc. RIFAMPIN 600 mg/10mL Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 23155-377_aa3c50ec-5e31-4b39-aab2-d42040b31d56 23155-377 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20140224 ANDA ANDA090424 Heritage Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 23155-378_4f9386bf-c714-47a0-b2f9-228dc0acb0a2 23155-378 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20140219 ANDA ANDA078945 Heritage Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 23155-473_a022af13-d0ea-41cf-88a0-fc298ce09faf 23155-473 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAVENOUS 20140902 ANDA ANDA203428 Heritage Pharmaceuticals Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 23155-487_d877f7f0-ed9d-48b0-8ea0-11e672d27307 23155-487 HUMAN PRESCRIPTION DRUG Achromycin V Tetracycline HCl CAPSULE ORAL 20131018 NDA NDA050278 Heritage Pharmaceuticals Inc. TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 23155-488_d877f7f0-ed9d-48b0-8ea0-11e672d27307 23155-488 HUMAN PRESCRIPTION DRUG Achromycin V Tetracycline HCl CAPSULE ORAL 20131018 NDA NDA050278 Heritage Pharmaceuticals Inc. TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 23155-500_73b410bf-cdb9-42f5-8aeb-965ad7cf1ee2 23155-500 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 Heritage Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 23155-501_73b410bf-cdb9-42f5-8aeb-965ad7cf1ee2 23155-501 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 Heritage Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 23155-502_73b410bf-cdb9-42f5-8aeb-965ad7cf1ee2 23155-502 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 Heritage Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 23264-100_097ec084-4863-319f-e054-00144ff88e88 23264-100 HUMAN OTC DRUG Aunt Ks Oatmeal, Collodial POWDER TOPICAL 20141110 OTC MONOGRAPH FINAL part347 Comfy Bottoms, LLC OATMEAL 1.25 g/100g 23264-200_097ec084-4863-319f-e054-00144ff88e88 23264-200 HUMAN OTC DRUG Aunt Ks Oatmeal, Colloidal POWDER TOPICAL 20141114 OTC MONOGRAPH FINAL part347 Comfy Bottoms, LLC OATMEAL 1.25 g/100g 23264-300_097ec084-4863-319f-e054-00144ff88e88 23264-300 HUMAN OTC DRUG Aunt Ks Oatmeal Colloidal POWDER TOPICAL 20141114 OTC MONOGRAPH FINAL part347 Comfy Bottoms, LLC OATMEAL 1.25 g/100g 23359-003_9fbf39a6-8783-4ecf-a8b1-63cd232049c6 23359-003 HUMAN PRESCRIPTION DRUG EXPECTUSS Liquid Carbetapentane Citrate, and Guaifenesin LIQUID ORAL 20091130 UNAPPROVED DRUG OTHER Centurion Labs, LLC CARBETAPENTANE CITRATE; GUAIFENESIN 20; 75 mg/5mL; mg/5mL 23359-016_dfc788c9-0300-4bda-94eb-43381b253733 23359-016 HUMAN PRESCRIPTION DRUG Lexuss 210 Codeine Phosphate and Chlorpheniramine Maleate LIQUID ORAL 20090415 UNAPPROVED DRUG OTHER Centurion Labs CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 2; 10 mg/5mL; mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CV 23359-017_596fa050-9c97-44a2-8177-27c66d839209 23359-017 HUMAN OTC DRUG Lusair Phenylephrine Hydrochloride and Guaifenesin LIQUID ORAL 20110831 OTC MONOGRAPH FINAL part341 Centurion Labs, LLC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 200; 7.5 mg/5mL; mg/5mL 23359-018_5912f335-4d16-43c6-b98f-f6aaa9da5877 23359-018 HUMAN PRESCRIPTION DRUG CENTUSSIN DHC Dihydrocodeine Bitartrate, Brompheniramine Maleate, and Phenylephrine Hydrochloride LIQUID ORAL 20091124 UNAPPROVED DRUG OTHER Centurion Labs, LLC BROMPHENIRAMINE MALEATE; DIHYDROCODEINE BITARTRATE; PHENYLEPHRINE HYDROCHLORIDE 4; 3; 7.5 mg/5mL; mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] CV 23359-019_e5ba77ff-9cc1-43de-9d6e-61cd3885a6ed 23359-019 HUMAN PRESCRIPTION DRUG Airacof CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE AND DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20100108 UNAPPROVED DRUG OTHER CENTURION LABS, LLC CODEINE PHOSPHATE; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 7.5; 12.5; 7.5 mg/5mL; mg/5mL; mg/5mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CV 23359-023_03a0c43b-b783-44a6-a9ff-ad862fb95a82 23359-023 HUMAN OTC DRUG Rydex Brompheniramine Maleate, Codeine Phosphate, Pseudoephedrine Hydrochloride LIQUID ORAL 20100514 OTC MONOGRAPH FINAL part341 Centurion Labs BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1.33; 6.33; 10 mg/5mL; mg/5mL; mg/5mL CV 23359-032_96be126a-fc7e-4c67-a86e-895e2ef3a26c 23359-032 HUMAN OTC DRUG Ninjacof chlophedianol hcl and pyrilamine maleate SOLUTION ORAL 20141015 OTC MONOGRAPH FINAL part341 Centurion Labs, LLC CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE 12.5; 12.5 mg/5mL; mg/5mL 23359-033_3804bfa6-1470-402f-9577-3f6f2616ff1e 23359-033 HUMAN OTC DRUG Ninjacof-A Ninjacof-A LIQUID ORAL 20141015 OTC MONOGRAPH FINAL part341 Centurion Labs, LLC ACETAMINOPHEN; CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE 160; 12.5; 12.5 mg/5mL; mg/5mL; mg/5mL 23359-040_47ba8466-68bc-4b31-89c9-6340dff26e9a 23359-040 HUMAN OTC DRUG Ninjacof-XG Codeine Phosphate LIQUID ORAL 20141120 OTC MONOGRAPH FINAL part341 Centurion Labs, LLC CODEINE PHOSPHATE; GUAIFENESIN 8; 200 mg/5mL; mg/5mL 23359-100_00a6e59a-4714-46ab-8119-12db89deff27 23359-100 HUMAN PRESCRIPTION DRUG Centratex Iron, Sodium Ascorbate, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Niacinamide, Calcium Pantothenate, Zinc Sulfate, Magnesium Sulfate, Manganese Sulfate, a CAPSULE ORAL 20090614 UNAPPROVED DRUG OTHER Centurion Labs CALCIUM PANTOTHENATE; CUPRIC SULFATE ANHYDROUS; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM SULFATE; MANGANESE SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE 10; .8; 15; 1; 106; 6.9; 1.3; 30; 5; 6; 200; 10; 18.2 mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 23359-105_8c1b2367-cec5-4a18-82a0-e132b4aece3a 23359-105 HUMAN PRESCRIPTION DRUG C-Nate DHA omega-3 fatty acids, icosapent, doconexent, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, cholecalciferol, ascorbic acid, .alpha.-tocopherol, d-, cupric sulfate, zinc oxide, ferrous fumarate and magnesium oxide CAPSULE, GELATIN COATED ORAL 20130101 UNAPPROVED DRUG OTHER Centurion Labs, LLC .ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 30; 100; 400; 1; 15; 28; 1; 30; 200; 20; 3; 3; 20 [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 23359-700_5e273c62-e582-4a40-90aa-c7c723cbcdf1 23359-700 HUMAN PRESCRIPTION DRUG Puralor 1-(c14-c18 esteroyl)-2-docosahexanoyl-sn-glycero-3-phosphocholine, 1-(c14-c18 esteroyl)-2-docosahexanoyl-sn-glycero-3-phosphoethanolamine, egg phospholipids , folic acid, leucovorin, levomefolic acid, anhydrous citric acid, sodium citrate, magnesium glycinate, acetylcysteine amide, cholecalciferol, thiamine, riboflavin, pantethine, niacin, cobamamide, ascorbic acid, magnesium l-threonate, papain and intrinsic factor TABLET, CHEWABLE ORAL 20140101 UNAPPROVED DRUG OTHER Centurion Labs, LLC 1-(C14-C18 ESTEROYL)-2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOCHOLINE; 1-(C14-C18 ESTEROYL)-2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE; ACETYLCYSTEINE AMIDE; ANHYDROUS CITRIC ACID; ASCORBIC ACID; CHOLECALCIFEROL; COBAMAMIDE; EGG PHOSPHOLIPIDS; FOLIC ACID; INTRINSIC FACTOR; LEUCOVORIN; LEVOMEFOLIC ACID; MAGNESIUM GLYCINATE; MAGNESIUM L-THREONATE; NIACIN; PANTETHINE; PAPAIN; RIBOFLAVIN; SODIUM CITRATE; THIAMINE 5; 2.5; 5; 1.6; 25; 100; 2; 42.5; .2; 2.5; 3; .4; 1; 2.5; .5; 2.5; 20; .5; .8; .5 mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 23360-151_7c65f43a-d202-4bcb-b582-9a667c395be0 23360-151 HUMAN PRESCRIPTION DRUG Sterile Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065397 Akorn - Strides LLC VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 23360-152_7c65f43a-d202-4bcb-b582-9a667c395be0 23360-152 HUMAN PRESCRIPTION DRUG Sterile Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065397 Akorn - Strides LLC VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 23360-153_10fb3ba8-d5ed-4efb-a4fb-62c1fb317a40 23360-153 HUMAN PRESCRIPTION DRUG STERILE VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065432 Akorn - Strides LLC VANCOMYCIN HYDROCHLORIDE 5 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 23360-160_dd793afb-bc0c-4f56-a925-238e139155c3 23360-160 HUMAN PRESCRIPTION DRUG Vecuronium bromide Vecuronium bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100915 ANDA ANDA090243 Akorn - Strides LLC VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 23390-1020_90c33e01-d809-4ce2-9d16-ab3ac535ebe4 23390-1020 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060505 UNAPPROVED MEDICAL GAS Denman Services, Inc. OXYGEN 99 L/100L 23558-0569_094fe364-ed6c-426e-af21-f6df02323d4d 23558-0569 HUMAN OTC DRUG Saline Nasal Sodium Chloride 0.65% SPRAY NASAL 20130701 OTC MONOGRAPH FINAL part349 Lee Pharmaceuticals SODIUM CHLORIDE 6.5 mg/mL 23558-5120_988b789b-822f-462a-9ea3-20035d78107e 23558-5120 HUMAN OTC DRUG Sound Body 12 Hour Nasal Original Oxymetazoline Hydrochloride SPRAY NASAL 20080131 OTC MONOGRAPH FINAL part341 Lee Pharmaceuticals OXYMETAZOLINE HYDROCHLORIDE 50 mg/100mL 23558-5504_b8f7b5eb-0477-4117-a170-cba92901808a 23558-5504 HUMAN OTC DRUG Cheracol D Cough Formula 4oz Maximum Strength Cough Relief SYRUP ORAL 20111201 OTC MONOGRAPH FINAL part341 Lee Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 23558-6881_7bce1be7-d7a9-44e9-8e84-2c3386c61da0 23558-6881 HUMAN OTC DRUG Saline Nasal 2oz Sodium chloride 0.65% SPRAY NASAL 20131001 OTC MONOGRAPH FINAL part349 Lee Pharmaceuticals SODIUM CHLORIDE 6.5 mg/mL 23558-6895_b7d106d2-d409-40f3-a138-8dd341c24bb6 23558-6895 HUMAN OTC DRUG Saline Nasal 3oz Sodium chloride 0.65% SPRAY NASAL 20131001 OTC MONOGRAPH FINAL part349 Lee Pharmaceuticals SODIUM CHLORIDE 6.5 mg/mL 23558-6896_bf6a1e44-7365-4717-94aa-25c933408314 23558-6896 HUMAN OTC DRUG Saline Nasal 1.5oz Sodium chloride 0.65% SPRAY NASAL 20131001 OTC MONOGRAPH FINAL part349 Lee Pharmaceuticals SODIUM CHLORIDE 6.5 mg/mL 23594-505_88ed2e2b-47c4-4c44-b5d3-2ef6775a41c5 23594-505 HUMAN PRESCRIPTION DRUG MILLIPRED PREDNISOLONE TABLET ORAL 20140301 ANDA ANDA080354 Zylera Pharmaceuticals, LLC PREDNISOLONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 23594-510_d8daf913-debe-4ab6-8a26-b80478e04ae3 23594-510 HUMAN PRESCRIPTION DRUG Millipred PREDNISOLONE SODIUM PHOSPHATE SOLUTION ORAL 20140301 ANDA ANDA078465 Zylera Pharmaceuticals, LLC PREDNISOLONE SODIUM PHOSPHATE 10 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 23594-780_179e3169-f8f5-4e3e-ad48-cd8ed29851ee 23594-780 HUMAN PRESCRIPTION DRUG Ulesfia benzyl alcohol LOTION TOPICAL 20140716 NDA NDA022129 Zylera Pharmaceuticals, LLC BENZYL ALCOHOL 50 mg/g Pediculicide [EPC] 23594-915_475f581a-0b1d-434c-ac99-bbb069c63c93 23594-915 HUMAN PRESCRIPTION DRUG Veripred 20 PREDNISOLONE SODIUM PHOSPHATE SOLUTION ORAL 20140801 ANDA ANDA078988 Zylera Pharmaceuticals, LLC PREDNISOLONE SODIUM PHOSPHATE 20 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 23635-115_37e7b8b6-ed80-441f-b9ff-e60d5642c4ed 23635-115 HUMAN PRESCRIPTION DRUG Xartemis XR oxycodone hydrochloride and acetaminophen TABLET, COATED ORAL 20130430 NDA NDA204031 Mallinckrodt, Inc ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 23635-310_8ea559dd-1dc4-48f3-8ff5-63d2e5e224db 23635-310 HUMAN PRESCRIPTION DRUG PENNSAID diclofenac sodium LIQUID TOPICAL 20100405 NDA NDA020947 Mallinckrodt, Inc DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 23635-408_1b5b11df-a604-47f4-bbfe-f291a728e038 23635-408 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110314 NDA NDA021217 Mallinckrodt, Inc HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 23635-412_1b5b11df-a604-47f4-bbfe-f291a728e038 23635-412 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110314 NDA NDA021217 Mallinckrodt, Inc HYDROMORPHONE HYDROCHLORIDE 12 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 23635-416_1b5b11df-a604-47f4-bbfe-f291a728e038 23635-416 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110314 NDA NDA021217 Mallinckrodt, Inc HYDROMORPHONE HYDROCHLORIDE 16 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 23635-432_1b5b11df-a604-47f4-bbfe-f291a728e038 23635-432 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120824 NDA NDA021217 Mallinckrodt, Inc HYDROMORPHONE HYDROCHLORIDE 32 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 23635-510_0df86a25-daac-4ce6-8a3b-1ad29af12d82 23635-510 HUMAN PRESCRIPTION DRUG PENNSAID diclofenac sodium SOLUTION TOPICAL 20120427 NDA NDA204623 Mallinckrodt, Inc DICLOFENAC SODIUM 20 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 23635-580_d7b668dd-f4c3-40eb-8b7d-53bae98dd6c3 23635-580 HUMAN PRESCRIPTION DRUG Roxicodone oxycodone hydrochloride TABLET ORAL 20090826 NDA NDA021011 Mallinckrodt, Inc OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 23635-581_d7b668dd-f4c3-40eb-8b7d-53bae98dd6c3 23635-581 HUMAN PRESCRIPTION DRUG Roxicodone oxycodone hydrochloride TABLET ORAL 20000831 NDA NDA021011 Mallinckrodt, Inc OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 23635-582_d7b668dd-f4c3-40eb-8b7d-53bae98dd6c3 23635-582 HUMAN PRESCRIPTION DRUG Roxicodone oxycodone hydrochloride TABLET ORAL 20000831 NDA NDA021011 Mallinckrodt, Inc OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 23636-1001_c9d5436a-b2fe-4e0f-aaa9-4a584fbd59e9 23636-1001 HUMAN OTC DRUG NBF Gingival SODIUM MONOFLUOROPHOSPHATE GEL DENTAL 20111111 UNAPPROVED DRUG OTHER NanoCureTech SODIUM MONOFLUOROPHOSPHATE .4 g/30g 23637-001_ddc612b6-7001-48ed-a724-1e12f932c618 23637-001 HUMAN OTC DRUG Bioxsine Series Pyrithione Zinc SHAMPOO TOPICAL 20120101 OTC MONOGRAPH FINAL part358H B'IOTA Laboratories PYRITHIONE ZINC 4.5 mL/300mL 23638-1111_78140cd2-3fad-44a9-b6bc-3cccb1ca6a9e 23638-1111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20111121 OTC MONOGRAPH NOT FINAL part333E Sanear Corporation ALCOHOL 665 mL/L 23644-001_1e5414d1-4106-4397-9ad0-53867fd8f9d3 23644-001 HUMAN PRESCRIPTION DRUG Oxygen, Compressed OXYGEN GAS RESPIRATORY (INHALATION) 20111215 UNAPPROVED MEDICAL GAS Home Care Pharmacy of Palm Coast, Inc. OXYGEN 1 L/L 23647-001_1e2b430a-63dc-4209-87df-f5454750e312 23647-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20111030 NDA NDA205712 SYOXSA, Inc. OXYGEN 995 mL/L 23647-002_db834e31-820a-47da-990f-c75609e7f9bb 23647-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20111030 NDA NDA205829 SYOXSA, Inc. NITROGEN 990 mL/L 23667-000_823053f7-390a-4354-81cb-39fcc84f6982 23667-000 HUMAN OTC DRUG Hawaiian Tropic Baby OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20100726 OTC MONOGRAPH FINAL part352 Formulated Solutions OCTOCRYLENE; OXYBENZONE 8; 3.5 mL/100mL; mL/100mL 23667-001_3940fae8-75c6-457d-b07d-a458067a842b 23667-001 HUMAN OTC DRUG Hawaiian Tropic Sheer Touch OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20100726 OTC MONOGRAPH FINAL part352 Formulated Solutions OCTOCRYLENE; OXYBENZONE 8; 3.5 mL/100mL; mL/100mL 23667-002_9db56e9b-efc0-4fb2-8ab6-a5b5ee1ade28 23667-002 HUMAN OTC DRUG Hawaiian Tropic Tanning AVOBENZONE,OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20100726 OTC MONOGRAPH FINAL part352 Formulated Solutions AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 2; 1.5 mL/100mL; mL/100mL; mL/100mL 23667-003_26d6de47-30ce-40e2-8c0a-0cdf71e99f13 23667-003 HUMAN OTC DRUG Hawaiian Tropic Tanning AVOBENZONE,OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20100726 OTC MONOGRAPH FINAL part352 Formulated Solutions AVOBENZONE; OCTOCRYLENE; OXYBENZONE .5; 1; .5 mL/100mL; mL/100mL; mL/100mL 23710-006_57bebd43-67af-461e-8e7f-43f131c7df64 23710-006 HUMAN PRESCRIPTION DRUG Salvax salicylic acid AEROSOL, FOAM TOPICAL 20090101 UNAPPROVED DRUG OTHER Quinnova Pharmaceuticals, Inc. SALICYLIC ACID 3.88 g/70g 23710-035_c1fc0ed7-6383-455a-98c3-ef44b312fc0d 23710-035 HUMAN PRESCRIPTION DRUG Hydro 35 Urea in a water and lipid based foam containing lactic acid AEROSOL, FOAM TOPICAL 20090620 UNAPPROVED OTHER Quinnova Pharmaceuticals, Inc. UREA 35 g/100g 23710-052_49f6982f-3855-4aee-bdac-47cf463a7908 23710-052 NON-STANDARDIZED ALLERGENIC Clease and Treat benzoyl peroxide pad and salicylic acid pad CLOTH TOPICAL 20090101 UNAPPROVED DRUG OTHER Quinnova Pharmaceuticals, Inc. BENZOYL PEROXIDE; SELENIUM SULFIDE .8; .5 g/5g; g/5g 23710-100_cfb958ff-a150-40e5-b246-76b0be2ec728 23710-100 HUMAN PRESCRIPTION DRUG ECOZA econazole nitrate AEROSOL, FOAM TOPICAL 20131025 NDA NDA205175 Quinnova Pharmaceuticals, LLC ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 23710-225_9d2f4f41-7b68-4a0c-addf-7823496e68df 23710-225 NON-STANDARDIZED ALLERGENIC TERSI selenium sulfide AEROSOL, FOAM TOPICAL 20091201 UNAPPROVED DRUG OTHER Quinnova Pharmaceuticals, Inc. SELENIUM SULFIDE 1.44 g/70g 23710-900_b9799388-885f-443a-baa5-2adce32f2583 23710-900 HUMAN PRESCRIPTION DRUG REPREXAIN Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 20100218 ANDA ANDA076642 Quinnova Pharmaceuticals, LLC HYDROCODONE BITARTRATE; IBUPROFEN 2.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 23710-901_b9799388-885f-443a-baa5-2adce32f2583 23710-901 HUMAN PRESCRIPTION DRUG REPREXAIN Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 20100218 ANDA ANDA076642 Quinnova Pharmaceuticals, LLC HYDROCODONE BITARTRATE; IBUPROFEN 5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 23710-902_b9799388-885f-443a-baa5-2adce32f2583 23710-902 HUMAN PRESCRIPTION DRUG REPREXAIN Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 20100218 ANDA ANDA076642 Quinnova Pharmaceuticals, LLC HYDROCODONE BITARTRATE; IBUPROFEN 10; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 23731-6030_2a879e57-001e-4ca6-9309-21da9a736599 23731-6030 HUMAN PRESCRIPTION DRUG triCitrasol Trisodium Citrate dihydrate SOLUTION EXTRACORPOREAL 20030710 NDA NDA010409 Citra Labs LLC TRISODIUM CITRATE DIHYDRATE .467 g/mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 23731-6051_3199d9f8-e065-4365-b951-7e26ac8fdf9c 23731-6051 HUMAN PRESCRIPTION DRUG Anticoagulant Citrate Dextrose A ANHYDROUS CITRIC ACID, DEXTROSE MONOHYDRATE, and TRISODIUM CITRATE DIHYDRATE SOLUTION EXTRACORPOREAL 20030710 NDA BN020037 Citra Labs ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 7.3; 24.5; 22 mg/mL; mg/mL; mg/mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 23731-7000_8670627b-e442-4189-af68-fa8a941a90e3 23731-7000 HUMAN PRESCRIPTION DRUG Rejuvesol Sodium Pyruvate, Inosine, Adenine, Sodium Phosphate, Dibasic, and Sodium Phosphate, Monobasic, Monohydrate SOLUTION EXTRACORPOREAL 19970226 NDA NDA950522 Citra Labs LLC ADENINE; INOSINE; SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PYRUVATE .034; 1.34; .73; .311; .55 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL 23916-1234_a84e1e06-1e66-456e-b0db-e492d3fbcde5 23916-1234 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060525 UNAPPROVED MEDICAL GAS Cedar Mountain Respiratory, Inc. OXYGEN 99 L/100L 24027-0699_54c2d68b-62d5-40e1-9e7f-a405057b400c 24027-0699 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20001023 UNAPPROVED MEDICAL GAS Broadway Medical Service & Supply, Inc. OXYGEN 99 L/100L 24090-410_b1a12c20-9938-45f0-94a1-723f179117b0 24090-410 HUMAN PRESCRIPTION DRUG NitroMist nitroglycerin AEROSOL, METERED SUBLINGUAL 20100501 NDA NDA021780 Akrimax Pharmaceuticals, LLC NITROGLYCERIN 400 ug/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 24090-450_7b091426-e819-450f-bf43-d0bdd1aefcfe 24090-450 HUMAN PRESCRIPTION DRUG InnoPran XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130601 NDA NDA021438 Akrimax Pharmaceuticals, LLC PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 24090-451_7b091426-e819-450f-bf43-d0bdd1aefcfe 24090-451 HUMAN PRESCRIPTION DRUG InnoPran XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130601 NDA NDA021438 Akrimax Pharmaceuticals, LLC PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 24090-470_1565d6c9-6116-4184-a288-0b6c668668eb 24090-470 HUMAN PRESCRIPTION DRUG Inderal LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19830419 NDA NDA018553 Akrimax Pharmaceuticals, LLC PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 24090-471_1565d6c9-6116-4184-a288-0b6c668668eb 24090-471 HUMAN PRESCRIPTION DRUG Inderal LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19830419 NDA NDA018553 Akrimax Pharmaceuticals, LLC PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 24090-473_1565d6c9-6116-4184-a288-0b6c668668eb 24090-473 HUMAN PRESCRIPTION DRUG Inderal LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19830419 NDA NDA018553 Akrimax Pharmaceuticals, LLC PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 24090-479_1565d6c9-6116-4184-a288-0b6c668668eb 24090-479 HUMAN PRESCRIPTION DRUG Inderal LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19830419 NDA NDA018553 Akrimax Pharmaceuticals, LLC PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 24090-490_af328868-3df0-40c0-9ad5-a8e708fcc61d 24090-490 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA022121 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 13 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 24090-491_af328868-3df0-40c0-9ad5-a8e708fcc61d 24090-491 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 24090-492_af328868-3df0-40c0-9ad5-a8e708fcc61d 24090-492 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 24090-493_af328868-3df0-40c0-9ad5-a8e708fcc61d 24090-493 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 24090-494_af328868-3df0-40c0-9ad5-a8e708fcc61d 24090-494 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 24090-495_af328868-3df0-40c0-9ad5-a8e708fcc61d 24090-495 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 24090-496_af328868-3df0-40c0-9ad5-a8e708fcc61d 24090-496 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 24090-497_af328868-3df0-40c0-9ad5-a8e708fcc61d 24090-497 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 24090-498_af328868-3df0-40c0-9ad5-a8e708fcc61d 24090-498 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 24090-499_af328868-3df0-40c0-9ad5-a8e708fcc61d 24090-499 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 24090-681_47563909-f924-455d-8d76-755c76bb3056 24090-681 HUMAN PRESCRIPTION DRUG Primlev oxycodone and acetaminophen TABLET ORAL 20111201 ANDA ANDA040608 Akrimax Pharmaceuticals, LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 300; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 24090-682_47563909-f924-455d-8d76-755c76bb3056 24090-682 HUMAN PRESCRIPTION DRUG Primlev oxycodone and acetaminophen TABLET ORAL 20111201 ANDA ANDA040608 Akrimax Pharmaceuticals, LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 300; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 24090-683_47563909-f924-455d-8d76-755c76bb3056 24090-683 HUMAN PRESCRIPTION DRUG Primlev oxycodone and acetaminophen TABLET ORAL 20111201 ANDA ANDA040608 Akrimax Pharmaceuticals, LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 300; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 24090-720_fbf30002-75be-44b3-876b-c6f460295c2b 24090-720 HUMAN PRESCRIPTION DRUG Suprenza phentermine hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20121214 NDA NDA202088 Akrimax Pharmaceuticals, LLC PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 24090-721_fbf30002-75be-44b3-876b-c6f460295c2b 24090-721 HUMAN PRESCRIPTION DRUG Suprenza phentermine hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20121214 NDA NDA202088 Akrimax Pharmaceuticals, LLC PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 24090-722_fbf30002-75be-44b3-876b-c6f460295c2b 24090-722 HUMAN PRESCRIPTION DRUG Suprenza phentermine hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20121214 NDA NDA202088 Akrimax Pharmaceuticals, LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 24160-001_7c98852b-0130-48f7-a9a7-99526a5a2341 24160-001 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20130718 ANDA ANDA091145 Bicon Pharmaceutical Inc. FOLIC ACID 1 mg/1 24165-0001_195a2d37-39eb-98c1-8bd3-2759cd2d69d9 24165-0001 HUMAN OTC DRUG Renew Sanicula, Abrotanum, Argentum nitricum, Arsenicum album, Baryta carbonica, Borax, Bryonia, Cactus grandiflorus, Calcarea fluorica, Calcarea phosphorica, Calcarea sulphurica, Chelidonium majus, Cholesterinum, Coffea cruda, Conium maculatum, Dulcamara, Ferrum phosphoricum, Fumaria officinalis, Gratiola officinalis, Helleborus niger, Hepar sulphuris calcareum, Hydrastis canadensis, Hydrofluoricum acidum, Iodium, Kali carbonicum, Kali muriaticum, Kali phosphoricum, Kali sulphuricum, Lilium tigrinum LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Anila, Inc. ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CARBONATE; BRYONIA ALBA ROOT; CALCIUM BICARBONATE; CALCIUM CHLORIDE; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; CALCIUM SULFIDE; CHELIDONIUM MAJUS; CHOLESTEROL; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; FUMARIA OFFICINALIS FLOWERING TOP; GOLDENSEAL; GRATIOLA OFFICINALIS; HELLEBORUS NIGER ROOT; HYDROFLUORIC ACID; IODINE; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHORUS; PODOPHYLLUM; POTASSIUM CARBONATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; PULSATILLA VULGARIS; SELENICEREUS GRANDIFLORUS STEM; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER NITRATE; SMILAX REGELII ROOT; SODIUM BICARBONATE; SODIUM BORATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; SOLANUM DULCAMARA TOP; SPIGELIA ANTHELMIA; SULFUR; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10; 10; 10; 10; 10; 10; 10; 15; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 24202-001_38db9a9a-8d68-4f7d-8ef8-9d128a8a394e 24202-001 HUMAN OTC DRUG CALCID ANTACID CALCIUM SUPPLEMENT REGULAR STRENGTH Calcium carbonate TABLET, CHEWABLE ORAL 20111230 OTC MONOGRAPH FINAL part331 Pro-ventas S.A. de C.V. CALCIUM CARBONATE 500 mg/1 24202-002_bd78021d-079f-4bfb-bfce-efff02835f00 24202-002 HUMAN OTC DRUG CALCID ANTACID CALCIUM SUPPLEMENT REGULAR STRENGTH Calcium carbonate TABLET, CHEWABLE ORAL 20111230 OTC MONOGRAPH FINAL part331 Pro-ventas S.A. de C.V. CALCIUM CARBONATE 500 mg/1 24208-002_230ed4da-acbf-4cf5-9626-bff59c221007 24208-002 HUMAN PRESCRIPTION DRUG VITRASE hyaluronidase, ovine INJECTION, SOLUTION SUBCUTANEOUS 20050201 NDA NDA021640 Bausch & Lomb Incorporated HYALURONIDASE, OVINE 200 [USP&apos'U]/mL Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient] 24208-004_670d3d31-2409-4f7e-b9c0-cfaa412bf17b 24208-004 HUMAN PRESCRIPTION DRUG Istalol Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20040802 NDA NDA021516 Bausch & Lomb Incorporated TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 24208-070_dcbac4df-3c93-4d6c-bb7c-03cf47db756e 24208-070 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20100831 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated WATER 99.05 mL/100mL 24208-073_824af78f-99f0-4ad1-b6b8-bea776f42596 24208-073 HUMAN OTC DRUG Collyrium for Fresh Eyes - Eye Wash Water SOLUTION OPHTHALMIC 20100831 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated WATER 99.05 mL/100mL 24208-099_55b73bf4-9ba6-4e76-9db9-030f787793c3 24208-099 HUMAN PRESCRIPTION DRUG Bromday bromfenac SOLUTION/ DROPS OPHTHALMIC 20100920 NDA NDA021664 Bausch & Lomb Incorporated BROMFENAC SODIUM .9 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24208-276_12fd3111-c952-4ea1-8c9d-3f1bfcf45137 24208-276 HUMAN OTC DRUG Muro 128 sodium chloride SOLUTION OPHTHALMIC 20110101 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated SODIUM CHLORIDE 20 mg/mL 24208-277_0ff44ba7-1e9f-435c-992d-ff735a8a14f8 24208-277 HUMAN OTC DRUG Muro 128 sodium chloride SOLUTION OPHTHALMIC 20110101 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated SODIUM CHLORIDE 50 mg/mL 24208-290_83292143-a4a4-49b9-a41b-aa492d9ba8d8 24208-290 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 19931129 ANDA ANDA064052 Bausch & Lomb Incorporated TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 24208-295_733c36b6-7b92-448c-be33-8beefcae990f 24208-295 HUMAN PRESCRIPTION DRUG Tobramycin and Dexamethasone Tobramycin and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19991027 ANDA ANDA064134 Bausch & Lomb Incorporated DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 24208-299_760eeae1-6004-4314-9b29-1f7d434714cf 24208-299 HUMAN PRESCRIPTION DRUG LOTEMAX loteprednol etabonate SUSPENSION/ DROPS OPHTHALMIC 19980309 NDA NDA020583 Bausch & Lomb Incorporated LOTEPREDNOL ETABONATE 5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 24208-300_56c00d32-a4ad-42ee-b964-e8e009dd1c4d 24208-300 HUMAN PRESCRIPTION DRUG Crolom cromolyn sodium SOLUTION/ DROPS OPHTHALMIC 19950130 ANDA ANDA074443 Bausch & Lomb Incorporated CROMOLYN SODIUM 40 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] 24208-313_638d3c3f-9960-43da-956e-0e28c77f533e 24208-313 HUMAN OTC DRUG Soothe Night Time white petrolatum mineral oil OINTMENT OPHTHALMIC 20111115 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated MINERAL OIL; PETROLATUM 200; 800 mg/g; mg/g 24208-314_8d90b181-36aa-4c80-8e43-ba6239d07c8e 24208-314 HUMAN PRESCRIPTION DRUG Flurbiprofen Sodium Flurbiprofen Sodium SOLUTION/ DROPS OPHTHALMIC 19950104 ANDA ANDA074447 Bausch & Lomb Incorporated FLURBIPROFEN SODIUM .3 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24208-315_697ea650-95b5-4814-8821-a99a85314679 24208-315 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim Sulfate SOLUTION/ DROPS OPHTHALMIC 19970214 ANDA ANDA064120 Bausch & Lomb Incorporated POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 24208-317_4dac0038-71cb-488e-9dd8-670fcf7b2073 24208-317 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium and Prednisolone Sodium Phosphate Sulfacetamide Sodium and Prednisolone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC 19951229 ANDA ANDA074449 Bausch & Lomb Incoporated PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM 2.3; 100 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 24208-324_50847498-17a7-495b-80e1-00ef6c0028c2 24208-324 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 19970325 ANDA ANDA074776 Bausch & Lomb Incorporated TIMOLOL MALEATE 5 mg/mL 24208-330_50847498-17a7-495b-80e1-00ef6c0028c2 24208-330 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 19970325 ANDA ANDA074778 Bausch & Lomb Incorporated TIMOLOL MALEATE 2.5 mg/mL 24208-342_45294e89-b8c2-45d7-828f-70d97ab9ec86 24208-342 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate SOLUTION NASAL 19990125 ANDA ANDA074830 Bauch & Lomb Incorporated DESMOPRESSIN ACETATE .1 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 24208-344_f2932169-353e-4db0-a534-d7cf6e247a27 24208-344 HUMAN PRESCRIPTION DRUG Flunisolide Flunisolide SOLUTION NASAL 20020220 ANDA ANDA074805 Bausch & Lomb Incorporated FLUNISOLIDE .25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 24208-347_01a90f37-30a7-4520-b4a7-1329af1ada02 24208-347 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19980618 ANDA ANDA075050 Bausch & Lomb Incorporated ALBUTEROL SULFATE 5 mg/mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 24208-349_6078752e-704f-4db9-8373-08a278a262bd 24208-349 HUMAN OTC DRUG Advanced Eye Relief/ Redness Instant Relief Naphazoline Hydrochloride and Polyethylene glycol 300 SOLUTION/ DROPS OPHTHALMIC 20100913 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated NAPHAZOLINE HYDROCHLORIDE; POLYETHYLENE GLYCOL 300 .1; 2 mg/mL; mg/mL 24208-353_9b0e1f87-2c16-48b9-8d71-23b49e80826b 24208-353 HUMAN PRESCRIPTION DRUG ALREX loteprednol etabonate SUSPENSION/ DROPS OPHTHALMIC 19980309 NDA NDA020803 Bausch & Lomb Incorporated LOTEPREDNOL ETABONATE 2 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 24208-358_4bba3d25-47f9-4766-8162-bf456e3c2701 24208-358 HUMAN PRESCRIPTION DRUG Zylet loteprednol etabonate and tobramycin SUSPENSION/ DROPS OPHTHALMIC 20041214 NDA NDA050804 Bausch & Lomb Incorporated LOTEPREDNOL ETABONATE; TOBRAMYCIN 5; 3 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 24208-367_cec44105-a602-4496-b61d-8eaad4e20b55 24208-367 HUMAN PRESCRIPTION DRUG CARTEOLOL HYDROCHLORIDE CARTEOLOL HYDROCHLORIDE SOLUTION/ DROPS OPHTHALMIC 20000120 ANDA ANDA075546 Bausch & Lomb Incorporated CARTEOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 24208-385_a52f37e7-bf18-49ef-b9ee-f8d49b8a825d 24208-385 HUMAN OTC DRUG Muro 128 sodium chloride OINTMENT OPHTHALMIC 20110101 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated SODIUM CHLORIDE 50 mg/g 24208-398_3cfd35d6-9753-491d-868b-0532587df4a2 24208-398 HUMAN PRESCRIPTION DRUG Ipratropium bromide Ipratropium bromide SPRAY, METERED NASAL 20030331 ANDA ANDA076025 Bausch & Lomb Incorporated IPRATROPIUM BROMIDE 21 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 24208-399_d300e34c-7901-4e11-b66c-85d80aed286f 24208-399 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SPRAY, METERED NASAL 20030331 ANDA ANDA076103 Bausch & Lomb Incorporated IPRATROPIUM BROMIDE 42 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 24208-410_568bf875-beda-4425-b175-decd86dcae12 24208-410 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC) 20080317 ANDA ANDA076128 Bausch & Lomb Incorporated OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 24208-411_9992cdcd-fb1e-428b-9be6-75460a4257bf 24208-411 HUMAN PRESCRIPTION DRUG Brimonidine Tartrate Brimonidine Tartrate SOLUTION/ DROPS OPHTHALMIC 20030528 ANDA ANDA076260 Bausch & Lomb Incorporated BRIMONIDINE TARTRATE 2 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 24208-416_e598efdf-1f61-461e-a2bb-5193244b39bb 24208-416 HUMAN PRESCRIPTION DRUG Retisert Fluocinolone Acetonide IMPLANT INTRAVITREAL 20050408 NDA NDA021737 Bausch & Lomb Incorporated FLUOCINOLONE ACETONIDE .59 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 24208-430_ebe1add7-5213-430c-8668-963c470c7123 24208-430 HUMAN OTC DRUG Opcon-A Naphazoline hydrochloride and Pheniramine maleate SOLUTION/ DROPS OPHTHALMIC 19940608 NDA NDA020065 Bausch & Lomb Incorporated NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL 24208-433_36e375ea-c5fb-4b8a-8d6a-4c89f69d7938 24208-433 HUMAN OTC DRUG Soothe Hydration povidone SOLUTION OPHTHALMIC 20110502 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated POVIDONES 12 mg/mL 24208-434_3665d266-c322-45b4-9e56-caa6035b092c 24208-434 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20040514 ANDA ANDA076622 Bausch & Lomb Incorporated OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 24208-439_6ffca24c-7186-48ac-8a50-43bb646deacd 24208-439 HUMAN PRESCRIPTION DRUG Bromfenac Bromfenac SOLUTION/ DROPS OPHTHALMIC 20131016 NDA AUTHORIZED GENERIC NDA021664 Bausch & Lomb Incorporated BROMFENAC SODIUM .9 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24208-443_5aecd5eb-be19-41af-a6a1-06b235d01057 24208-443 HUMAN PRESCRIPTION DRUG Lotemax loteprednol etabonate OINTMENT OPHTHALMIC 20110415 NDA NDA200738 Bausch & Lomb Incorporated LOTEPREDNOL ETABONATE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 24208-444_f105cf8b-a5b9-46a8-b22b-ba154d2b97d3 24208-444 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin hydrochloride SOLUTION/ DROPS OPHTHALMIC 20040609 ANDA ANDA076754 Bausch & Lomb Incorporated CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 24208-446_c6a61954-6d3e-4214-970e-132f6b24f4ea 24208-446 HUMAN PRESCRIPTION DRUG Besivance Besifloxacin SUSPENSION OPHTHALMIC 20090528 NDA NDA022308 Bausch & Lomb Incorporated BESIFLOXACIN 6 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 24208-450_96a31173-e326-413f-b352-2fc6a4540f35 24208-450 HUMAN OTC DRUG Advanced Eye Relief/ Redness Maximum Relief Naphazoline Hydrochloride and Hypromellose SOLUTION/ DROPS OPHTHALMIC 20100902 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated HYPROMELLOSES; NAPHAZOLINE HYDROCHLORIDE .3; 5 mg/mL; mg/mL 24208-453_a1d7ca31-8e46-49d2-991e-354a7bf397ac 24208-453 HUMAN OTC DRUG Advanced Eye Relief/ Dry Eye/ Rejuvenation Lubricant propylene glycol SOLUTION/ DROPS OPHTHALMIC 20100901 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated PROPYLENE GLYCOL .95 mL/mL 24208-454_e08e722c-fc19-4637-a46f-8996fe593a18 24208-454 HUMAN OTC DRUG Advanced Eye Relief Dry Eye Rejuvenation glycerin propylene glycol SOLUTION/ DROPS OPHTHALMIC 20100901 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated GLYCERIN; PROPYLENE GLYCOL 3; 10 mg/mL; mg/mL 24208-457_80dcc7ed-0b04-4cc7-a6e5-229f558ff4df 24208-457 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION/ DROPS OPHTHALMIC 20071228 ANDA ANDA078792 Bausch & Lomb Incorporated DICLOFENAC SODIUM 1 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24208-463_393a82f1-1957-424b-835d-b2ae48a1e1c0 24208-463 HUMAN PRESCRIPTION DRUG Latanoprost Latanoprost SOLUTION/ DROPS OPHTHALMIC 20110322 ANDA ANDA201006 Bausch & Lomb Incorporated LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 24208-478_abc05828-67d4-47aa-bfda-be213872ca61 24208-478 HUMAN OTC DRUG Soothe TIRED EYES glycerin SOLUTION/ DROPS OPHTHALMIC 20120501 OTC MONOGRAPH FINAL part349 Baush & Lomb Incorporated GLYCERIN 10 mg/mL 24208-485_a57fb7b3-63eb-45da-9b15-e4cc41f16bd2 24208-485 HUMAN PRESCRIPTION DRUG Dorzolamide HCl Dorzolamide HCl SOLUTION/ DROPS OPHTHALMIC 20090625 ANDA ANDA090143 Bausch & Lomb Incorporated DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] 24208-486_8311c675-7df1-4e87-b462-55ef8cfecab0 24208-486 HUMAN PRESCRIPTION DRUG Dorzolamide HCl /Timolol Maleate Dorzolamide HCl /Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20090714 ANDA ANDA090037 Bausch & Lomb Incorporated DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 6.83 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 24208-490_a80a0e31-d229-4cdb-8573-2fa1d5eac41c 24208-490 HUMAN OTC DRUG Soothe XP light mineral oil and mineral oil SOLUTION/ DROPS OPHTHALMIC 20100826 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated LIGHT MINERAL OIL; MINERAL OIL 10; 45 mg/mL; mg/mL 24208-495_5065fa7a-fb70-4258-8b3b-a5eddd86de10 24208-495 HUMAN OTC DRUG Soothe glycerin and propylene glycol SOLUTION/ DROPS OPHTHALMIC 20100826 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated GLYCERIN; PROPYLENE GLYCOL 6; 6 mg/mL; mg/mL 24208-503_344f8734-deed-4934-bdce-8732fa29c830 24208-503 HUMAN PRESCRIPTION DRUG LOTEMAX loteprednol etabonate GEL OPHTHALMIC 20121012 NDA NDA202872 Bausch & Lomb Incorporated LOTEPREDNOL ETABONATE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 24208-505_371d1b92-5189-42bb-806f-6021eef34655 24208-505 HUMAN PRESCRIPTION DRUG Levobunolol Hydrochloride Levobunolol Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19940304 ANDA ANDA074326 Bausch & Lomb Incorporated LEVOBUNOLOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 24208-535_68390779-b103-4454-bd5d-3139313fb9ee 24208-535 HUMAN PRESCRIPTION DRUG ZIRGAN ganciclovir GEL OPHTHALMIC 20100430 NDA NDA022211 Bausch & Lomb Incorporated GANCICLOVIR 1.5 mg/g Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 24208-539_85c0d9cf-f51b-4b1a-b3cd-1579032d8e71 24208-539 HUMAN PRESCRIPTION DRUG Miochol E acetylcholine chloride KIT 19930922 NDA NDA020213 Bausch & Lomb Incorporated 24208-544_30a388e9-b7e7-400d-8574-baf60a59375f 24208-544 HUMAN OTC DRUG Soothe Long Lasting Povidone SOLUTION OPHTHALMIC 20130601 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated POVIDONES 20 mg/mL 24208-545_371d1b92-5189-42bb-806f-6021eef34655 24208-545 HUMAN PRESCRIPTION DRUG Levobunolol Hydrochloride Levobunolol Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19940304 ANDA ANDA074307 Bausch & Lomb Incorporated LEVOBUNOLOL HYDROCHLORIDE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 24208-555_5cfad642-e7d0-4451-8bd4-29665208ac8d 24208-555 HUMAN PRESCRIPTION DRUG Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate OINTMENT OPHTHALMIC 20080425 ANDA ANDA064046 Bausch & Lomb Incorporated BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 24208-561_34ce556a-6aca-415e-9808-fd9646c1300a 24208-561 HUMAN PRESCRIPTION DRUG Antipyrine and Benzocaine Antipyrine and Benzocaine SOLUTION AURICULAR (OTIC) 19900930 UNAPPROVED DRUG OTHER Bausch & Lomb Incorporated ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 24208-580_bde455c4-7557-48dd-aabe-621d8ed85d95 24208-580 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 19940511 ANDA ANDA064048 Bausch & Lomb Incorporated GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 24208-585_1f4b97ea-4876-4d7f-acf3-ae07dd71b268 24208-585 HUMAN PRESCRIPTION DRUG Tropicamide Tropicamide SOLUTION/ DROPS OPHTHALMIC 19940727 ANDA ANDA040064 Bausch & Lomb Incorporated TROPICAMIDE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 24208-590_1f4b97ea-4876-4d7f-acf3-ae07dd71b268 24208-590 HUMAN PRESCRIPTION DRUG Tropicamide Tropicamide SOLUTION/ DROPS OPHTHALMIC 19940727 ANDA ANDA040067 Bausch & Lomb Incorporated TROPICAMIDE 5 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 24208-601_b387f9e6-aeb3-46b3-bebd-40a9d36248d7 24208-601 HUMAN OTC DRUG Alaway Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20061201 NDA NDA021996 Bausch & Lomb Incorporated KETOTIFEN FUMARATE .25 mg/mL 24208-602_9c7349ef-bb19-421e-8db8-ba0a080d0ab1 24208-602 HUMAN PRESCRIPTION DRUG Prolensa Bromfenac Sodium SOLUTION/ DROPS OPHTHALMIC 20130408 NDA NDA203168 Bausch & Lomb Incorporated BROMFENAC SODIUM .7 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24208-615_54e19a39-60c6-4ce5-874f-d4122ba96279 24208-615 HUMAN PRESCRIPTION DRUG Acetic Acid Acetic Acid SOLUTION/ DROPS AURICULAR (OTIC) 19940225 ANDA ANDA040063 Bausch & Lomb Incorporated ACETIC ACID 2 mg/mL 24208-629_81dbc9df-1ddd-46f4-a788-43dc22811e77 24208-629 HUMAN PRESCRIPTION DRUG Bepreve bepotastine besilate SOLUTION/ DROPS OPHTHALMIC 20090908 NDA NDA022288 Bausch & Lomb Incorporated BEPOTASTINE BESILATE 15 mg/mL Histamine-1 Receptor Antagonist [EPC] 24208-631_55bcf205-bba5-4be3-993a-4a52e021b12c 24208-631 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 Bausch & Lomb Incoporated HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 24208-635_a5f50a91-45db-4de0-8cfb-dfd33da7475f 24208-635 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19960828 ANDA ANDA064065 Bausch & Lomb Incorporated HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 24208-657_ab98750f-60c2-4c73-afee-97e4dcafb312 24208-657 HUMAN OTC DRUG Soothe glycerin and propylene glycol SOLUTION/ DROPS OPHTHALMIC 20101027 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated GLYCERIN; PROPYLENE GLYCOL .55; .55 mg/mL; mg/mL 24208-670_983d205d-4212-44d9-98c5-3c5cf60cafa4 24208-670 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium sulfacetamide sodium SOLUTION/ DROPS OPHTHALMIC 19941228 ANDA ANDA040066 Bausch & Lomb Incorporated SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 24208-715_20e33e7f-db37-496e-8ff6-bc6b2068ca17 24208-715 HUMAN PRESCRIPTION DRUG PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS OPHTHALMIC 19940729 ANDA ANDA040070 Bausch & Lomb Incorporated PREDNISOLONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 24208-720_7559e7af-6ed2-4e5b-966d-4ee46c1ef545 24208-720 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC 19960726 ANDA ANDA040069 Bausch & Lomb Incorporated DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 24208-730_75f544ac-acf5-4a59-923a-e8040210977f 24208-730 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19950929 ANDA ANDA040074 Bausch & Lomb Incorporated PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] 24208-732_3f4f1eaa-2262-4883-89cb-f1b29d4d00b4 24208-732 HUMAN PRESCRIPTION DRUG Fluorescein Sodium and Benoxinate Hydrochloride Fluorescein Sodium and Benoxinate Hydrochloride SOLUTION OPHTHALMIC 19950101 UNAPPROVED DRUG OTHER Bausch & Lomb Incorporated BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM 4; 2.5 mg/mL; mg/mL Diagnostic Dye [EPC],Dyes [MoA] 24208-735_d847e475-16a2-4fc3-8f1f-e9c499fc50b4 24208-735 HUMAN PRESCRIPTION DRUG Cyclopentolate Hydrochloride Cyclopentolate Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19940429 ANDA ANDA040075 Bausch & Lomb Incorporated CYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL 24208-740_d18ebd14-07c8-480b-9909-88215c4021f7 24208-740 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride SOLUTION OPHTHALMIC 19900930 UNAPPROVED DRUG OTHER Bausch & Lomb Incorporated PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 24208-780_ab4612c6-3b08-44ba-8a43-b44e62aabbbc 24208-780 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 19951030 ANDA ANDA064064 Bausch & Lomb Incorporated BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 10000 [USP'U]/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] 24208-785_c1ba5baa-9e69-4d2d-9f09-9341fd92f98b 24208-785 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone OINTMENT OPHTHALMIC 19951030 ANDA ANDA064068 Bausch & Lomb Incorporated BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 10; 3.5; 10000 [USP&apos'U]/g; mg/g; mg/g; [USP&apos'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 24208-790_22ce5586-13cd-4b6b-abbd-17f6429ac062 24208-790 HUMAN PRESCRIPTION DRUG NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN neomycin sulfate, polymyxin b sulfate and gramicidin SOLUTION/ DROPS OPHTHALMIC 19960131 ANDA ANDA064047 Bausch & Lomb Incorporated GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE .025; 1.75; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 24208-795_5665f896-72a1-456d-a1f8-209978614c0a 24208-795 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone OINTMENT OPHTHALMIC 19940725 ANDA ANDA064063 Bausch & Lomb Incorporated DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 24208-825_c0a56d60-0914-42b1-af59-c56afe93d18c 24208-825 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate OINTMENT OPHTHALMIC 19900930 UNAPPROVED DRUG OTHER Bausch & Lomb Incorporated ATROPINE SULFATE 10 mg/g Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 24208-830_322c5da9-9ffc-4deb-9593-3437df10a662 24208-830 HUMAN PRESCRIPTION DRUG Neomycin Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19950913 ANDA ANDA064135 Bausch & Lomb Incorporated DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 24208-901_e99c2689-2408-4ab5-b8ff-406d8ed650e4 24208-901 HUMAN OTC DRUG Alaway Ketotifen Fumarate KIT 20061201 NDA NDA021996 Bausch & Lomb Incorporated 24208-910_afcc9f01-dd91-468e-8f58-896b68c0d2ff 24208-910 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940729 ANDA ANDA064067 Bausch & Lomb Incorporated ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24208-920_c8476463-ad35-4d58-984b-064346ab6876 24208-920 HUMAN PRESCRIPTION DRUG Tetracaine Hydrochloride Tetracaine Hydrochloride SOLUTION OPHTHALMIC 19900930 UNAPPROVED DRUG OTHER Bausch & Lomb Incorporated TETRACAINE HYDROCHLORIDE 5 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 24236-004_1d693aac-3607-4737-9bdb-5824340c85e1 24236-004 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET ORAL 20101213 ANDA ANDA040218 REMEDYREPACK INC. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 24236-005_2c62c2f2-6b60-42c1-bf5e-0411437a5310 24236-005 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET ORAL 20101213 ANDA ANDA040218 REMEDYREPACK INC. AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 24236-006_d1f88b46-331d-449f-ba80-178c64c37153 24236-006 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET ORAL 20101213 ANDA ANDA040218 REMEDYREPACK INC. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 24236-009_d8b3c576-c09b-4b22-a7de-14c399a920a3 24236-009 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20130404 ANDA ANDA040419 REMEDYREPACK INC. ACETAMINOPHEN 300 mg/1 24236-012_2ce5cbf9-335b-4ec4-a425-e0f094b88748 24236-012 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20130521 ANDA ANDA078060 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 24236-012_3a159175-37c0-4ecf-b8e6-1b6e5a4638dd 24236-012 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET ORAL 20120913 ANDA ANDA078060 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 24236-012_6b820129-3877-4044-85a6-19ba0edc0fa6 24236-012 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20131008 ANDA ANDA078060 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 24236-012_baa1d645-fd3c-4412-8796-c5df406e41eb 24236-012 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20131205 ANDA ANDA078060 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 24236-012_f9f5f969-4255-4a1c-a77b-2ab931001f41 24236-012 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20111214 ANDA ANDA078060 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 24236-015_2ff374d3-06b3-488a-96d1-f3cf2cbfc2c6 24236-015 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20110906 ANDA ANDA089058 REMEDYREPACK INC. BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 24236-049_ac41fbac-d932-45da-b422-d605efa155d7 24236-049 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20120112 ANDA ANDA062396 REMEDYREPACK INC. DOXYCYCLINE HYCLATE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 24236-051_85f34015-ce5c-4c3f-a59e-a0ee7d9a6aa7 24236-051 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20131112 ANDA ANDA075483 REMEDYREPACK INC. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 24236-062_c76367e7-4262-45c9-956f-3d5893795beb 24236-062 HUMAN PRESCRIPTION DRUG GEODON ZIPRASIDONE HYDROCHLORIDE CAPSULE ORAL 20101220 NDA NDA020825 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 24236-063_5bf56ea3-7d35-4d1e-ae9e-1aa2b58bdf67 24236-063 HUMAN PRESCRIPTION DRUG GEODON ZIPRASIDONE HYDROCHLORIDE CAPSULE ORAL 20101220 NDA NDA020825 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 24236-068_54348b48-a8d3-4b2b-822d-3fcec6bd1124 24236-068 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE TABLET ORAL 20130927 ANDA ANDA089160 REMEDYREPACK INC. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 24236-068_e6fc47e5-4a8f-4918-aca6-f6013f66efb3 24236-068 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE TABLET ORAL 20120910 ANDA ANDA040084 REMEDYREPACK INC. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 24236-070_6ddb431a-5cdc-49e8-bd40-69020375b500 24236-070 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20130319 ANDA ANDA040156 REMEDYREPACK INC. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 24236-070_cfc063b3-6919-42c0-b13f-9daf9649fe2a 24236-070 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20130409 ANDA ANDA040156 REMEDYREPACK INC. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 24236-078_c8b4c508-d316-4754-a217-2a7876413236 24236-078 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20130318 NDA NDA021323 REMEDYREPACK INC. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 24236-083_034793fd-9f6e-400f-9c9e-8869471347ad 24236-083 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20130521 ANDA ANDA073192 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 24236-083_56a4ffc7-39d5-4bea-9882-6011b279f3f0 24236-083 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20111116 ANDA ANDA073192 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 24236-083_7b27b92e-d04c-4502-94a1-8348b09b843a 24236-083 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20130523 ANDA ANDA073192 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 24236-083_a0933a9d-1b3e-4aec-b312-a85781c486be 24236-083 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE CAPSULE ORAL 20120821 ANDA ANDA073192 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 24236-097_8e7c6dfb-6fab-4f16-bf55-180f87fe41b9 24236-097 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20130301 ANDA ANDA074201 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24236-110_0a7cc5d7-42b1-41ac-8a36-7ffeb07a6f3f 24236-110 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20120828 ANDA ANDA083426 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 24236-110_314d8d75-4eae-4880-9e9a-88a0f6e9fb22 24236-110 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20121221 ANDA ANDA083426 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 24236-110_3675f4a9-e1b9-4051-b645-d65aef086e26 24236-110 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20130408 ANDA ANDA083426 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 24236-120_e8632d09-2c26-4c55-b9b5-eaab449a69a3 24236-120 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20130424 NDA NDA020639 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 24236-121_5711869e-adea-400a-a4e2-ed416866a1a9 24236-121 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20130410 NDA NDA020639 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 24236-121_afa5f7c9-acb2-434a-be91-729fa517fb81 24236-121 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20130410 NDA NDA020639 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 24236-121_d46956e4-bdf0-4db3-9d68-4853ebae866c 24236-121 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20130410 NDA NDA020639 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 24236-123_7d21b307-0bc3-4e17-8617-26599db33bab 24236-123 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20130410 NDA NDA020639 REMEDYREPACK INC. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 24236-132_1d761f33-6ffc-466d-88cf-f497e95f21e9 24236-132 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 20130318 NDA NDA018858 REMEDYREPACK INC. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24236-133_6340f581-229d-4f1d-ae2e-8909438c0f01 24236-133 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20130408 ANDA ANDA088496 REMEDYREPACK INC. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 24236-156_7802ae21-5adb-48dc-b116-93b86cb6e3aa 24236-156 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20111212 ANDA ANDA075828 REMEDYREPACK INC. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 24236-166_a43c6d67-81f8-4b5f-b377-0bd8a1649ba8 24236-166 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20110404 ANDA ANDA071783 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 24236-167_efd18535-8e1f-4281-9342-ba44aedbeca7 24236-167 HUMAN PRESCRIPTION DRUG CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE ORAL 20101216 ANDA ANDA065061 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 24236-168_3b776290-8084-4703-b850-97828fd0ac54 24236-168 HUMAN PRESCRIPTION DRUG HALOPERIDOL HALOPERIDOL TABLET ORAL 20101221 ANDA ANDA071209 REMEDYREPACK INC. HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 24236-168_7bb5f6c8-1348-45ee-b418-d4bf38474307 24236-168 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20130911 ANDA ANDA071209 REMEDYREPACK INC. HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 24236-184_d46e3deb-08f1-4d95-8c36-0fdcfd4cbd71 24236-184 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130402 ANDA ANDA085159 REMEDYREPACK INC. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 24236-186_255c1639-ef49-48f8-a868-52159235fba7 24236-186 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20111215 ANDA ANDA070033 REMEDYREPACK INC. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 24236-192_647712cf-d141-4505-9253-3bb5474c8ea7 24236-192 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20130318 ANDA ANDA076243 REMEDYREPACK INC. LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] 24236-199_c61daae8-b0c4-43f0-b923-f2a684c8f7da 24236-199 HUMAN PRESCRIPTION DRUG Bisacodyl Bisacodyl TABLET ORAL 20100804 ANDA ANDA075659 REMEDYREPACK INC. BISACODYL 5 mg/1 Increased Large Intestinal Motility [PE],Stimulant Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 24236-200_51112c91-906e-4fdf-996e-7e0b06cb1dcf 24236-200 HUMAN PRESCRIPTION DRUG DIPHENDYDRAMINE HYDROCHLORIDE DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20101217 ANDA ANDA075659 REMEDYREPACK INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 24236-202_7a4ff3a0-b9b4-4b3c-ad0d-36c202800dc2 24236-202 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE, COATED ORAL 20131029 ANDA ANDA065028 REMEDYREPACK INC. RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 24236-204_76170d85-4bd8-41f6-a80c-a9a7dc5683a0 24236-204 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 20130320 ANDA ANDA080154 REMEDYREPACK INC. PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 24236-205_33b553e8-71f5-45d0-a103-d71f1ab6266f 24236-205 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20111213 ANDA ANDA087342 REMEDYREPACK INC. PREDNISONE 20 mg/1 24236-214_7b0504b7-9bf5-4246-b079-0ab307bb2ba5 24236-214 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20130213 NDA NDA018832 REMEDYREPACK INC. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 24236-217_52e1b869-7797-46ca-a5ce-0b58baad9a27 24236-217 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20130708 ANDA ANDA084122 REMEDYREPACK INC. PREDNISONE 10 mg/1 24236-217_5cd3579d-d085-4458-8bf6-a19bac538a95 24236-217 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20130708 ANDA ANDA084122 REMEDYREPACK INC. PREDNISONE 10 mg/1 24236-217_ae73c589-ef1f-4e4e-897a-9c46676f5c46 24236-217 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20130213 ANDA ANDA087800 REMEDYREPACK INC. PREDNISONE 10 mg/1 24236-220_fdf7bfb4-f6e5-4efa-84e8-bf50c34e2573 24236-220 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130319 ANDA ANDA076704 REMEDYREPACK INC. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 24236-231_753fca89-3b0d-4ab1-a572-6e3690c0b047 24236-231 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 20130315 ANDA ANDA040161 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 24236-234_55faa2de-5f57-47da-8771-0b2aaaf525e3 24236-234 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130701 ANDA ANDA075155 REMEDYREPACK INC. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 24236-234_de34239a-62c2-4504-9cc5-2414333d7a6c 24236-234 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130318 ANDA ANDA075155 REMEDYREPACK INC. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 24236-248_0a45c405-e375-4dc2-8f38-63d174f02761 24236-248 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130904 ANDA ANDA088832 REMEDYREPACK INC. PREDNISONE 10 mg/1 24236-248_37c4f2cc-b961-4d56-8525-d6c9175818df 24236-248 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20131015 ANDA ANDA088832 REMEDYREPACK INC. PREDNISONE 10 mg/1 24236-248_aa5490cd-5358-4b98-bba1-f122011b7edf 24236-248 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130926 ANDA ANDA088832 REMEDYREPACK INC. PREDNISONE 10 mg/1 24236-248_cab966f8-9af1-4d04-8315-535466d2753a 24236-248 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130919 ANDA ANDA088832 REMEDYREPACK INC. PREDNISONE 10 mg/1 24236-248_dd1028d5-d9d7-4501-9163-6140f3ed0094 24236-248 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20130118 ANDA ANDA088832 REMEDYREPACK INC. PREDNISONE 10 mg/1 24236-254_e1207204-f37a-467b-accb-2e71fa002c9a 24236-254 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20130410 NDA NDA020592 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 24236-258_6a7baeed-2430-4de0-a0cc-4ef125f57975 24236-258 HUMAN PRESCRIPTION DRUG CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED ORAL 20101216 ANDA ANDA084114 REMEDYREPACK INC. CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 24236-260_fc38ed31-6423-4313-a511-731f93a68ead 24236-260 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20130327 ANDA ANDA040145 REMEDYREPACK INC. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 24236-262_7b5ccd45-650b-4165-9ace-75b3231ca140 24236-262 HUMAN PRESCRIPTION DRUG GEODON ZIPRASIDONE HYDROCHLORIDE CAPSULE ORAL 20101220 NDA NDA020825 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 24236-266_41468d85-872e-4a31-be9b-03a2f9a74a47 24236-266 HUMAN PRESCRIPTION DRUG GlipizideER ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131112 ANDA ANDA076467 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 24236-267_16b5ef6f-d7f8-40b6-86ed-f422abc89acb 24236-267 HUMAN PRESCRIPTION DRUG GEODON ZIPRASIDONE HYDROCHLORIDE CAPSULE ORAL 20101220 NDA NDA020825 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 24236-271_f064c60d-77b7-473a-b460-34120e0c8345 24236-271 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 20130315 NDA NDA020564 REMEDYREPACK INC. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 24236-279_ff49bc21-b90d-4863-b0a8-6e43a9ff9484 24236-279 HUMAN PRESCRIPTION DRUG ABILIFY ABILIFY TABLET ORAL 20101214 ANDA ANDA075659 REMEDYREPACK INC. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] 24236-284_9d74ed3a-ab2d-4f42-b92f-ef7e1beda6a6 24236-284 HUMAN PRESCRIPTION DRUG Viread TENOFOVIR DISOPROXIL FUMARATE TABLET, COATED ORAL 20130328 NDA NDA021356 REMEDYREPACK INC. TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 24236-287_5bf5d87d-6e4b-48b2-b76b-804a90b96cbe 24236-287 HUMAN PRESCRIPTION DRUG VIRACEPT NELFINAVIR MESYLATE TABLET, FILM COATED ORAL 20130327 NDA NDA021503 REMEDYREPACK INC. NELFINAVIR MESYLATE 625 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 24236-289_be611bd2-f772-4189-8c73-56f3cd07ef4d 24236-289 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR SULFATE CAPSULE, GELATIN COATED ORAL 20130326 NDA NDA021567 REMEDYREPACK INC. ATAZANAVIR SULFATE 150 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 24236-292_3933c1fc-d27f-435a-a93b-51df960928e0 24236-292 HUMAN PRESCRIPTION DRUG Atripla efavirenz, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20130329 NDA NDA021937 REMEDYREPACK INC. EFAVIRENZ 600 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] 24236-296_03c21b09-f09d-460a-9144-8620d56e6779 24236-296 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20130327 ANDA ANDA040337 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 24236-300_603573b2-fee5-453d-b655-73e6077d0f83 24236-300 HUMAN PRESCRIPTION DRUG EPZICOM abacavir sulfate and lamivudine TABLET, FILM COATED ORAL 20130315 NDA NDA021652 REMEDYREPACK INC. ABACAVIR SULFATE 600 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 24236-303_7afb6bba-b106-403b-974a-e214eb739478 24236-303 HUMAN PRESCRIPTION DRUG Truvada emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20130403 NDA NDA021752 REMEDYREPACK INC. EMTRICITABINE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 24236-317_123579cb-0283-4e2d-b383-72e1e1ffca63 24236-317 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20130614 ANDA ANDA075483 REMEDYREPACK INC. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 24236-323_7d2e28ca-efd8-4ef3-8230-8aadd8ca7925 24236-323 HUMAN PRESCRIPTION DRUG CHLORPROMAZINE HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED ORAL 20101216 ANDA ANDA084112 REMEDYREPACK INC. CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 24236-332_8ac75f3a-e4ef-4ce6-a50b-ba194825f77e 24236-332 HUMAN PRESCRIPTION DRUG METHOCARBAMOL METHOCARBAMOL TABLET ORAL 20130119 ANDA ANDA085159 REMEDYREPACK INC. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 24236-341_32113414-5561-482b-8d58-ce14881f075b 24236-341 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20130821 ANDA ANDA087479 REMEDYREPACK INC. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 24236-341_983effba-4824-44a1-bbb2-f3d92596aa99 24236-341 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20130624 ANDA ANDA087479 REMEDYREPACK INC. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 24236-350_4445a7fd-2389-4a0b-b854-15398f2ef363 24236-350 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130410 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 24236-353_ab3b8372-b0bd-4acd-8ea7-216d18bc1ecc 24236-353 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20110309 ANDA ANDA040145 REMEDYREPACK INC. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 24236-359_a1e8a822-7dd7-4658-8579-95dfa17d3d1a 24236-359 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE TABLET ORAL 20121224 ANDA ANDA040355 REMEDYREPACK INC. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 24236-360_12fba177-432d-4342-bf8f-365b93b7aa72 24236-360 HUMAN PRESCRIPTION DRUG Erythrocin Stearate ERYTHROMYCIN STEARATE TABLET ORAL 20120827 ANDA ANDA060359 REMEDYREPACK INC. ERYTHROMYCIN STEARATE 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24236-361_bf2c3d43-a01a-4b26-b073-9d6c0be05894 24236-361 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET ORAL 20111213 ANDA ANDA070994 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 24236-364_22e3bfac-ae77-464e-8ef1-82d8f73b2ac1 24236-364 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim SULFAMETHOXAZOLE TABLET ORAL 20120828 ANDA ANDA076899 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 24236-364_a3060fc7-5b4e-44f5-b053-142dc136500b 24236-364 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole TABLET ORAL 20130730 ANDA ANDA076899 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 24236-364_e160fa88-63a1-41d7-b373-30a30d53363a 24236-364 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole TABLET ORAL 20131015 ANDA ANDA076899 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 24236-385_1e862aa1-3596-47a1-98c8-4a50c513b62c 24236-385 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride TABLET ORAL 20130213 ANDA ANDA040317 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 24236-387_f9db011a-6ccc-443d-b099-f72f50eeccc8 24236-387 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130216 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 24236-389_4c4fcfe8-e467-45b5-86d1-4d17558f45ef 24236-389 HUMAN PRESCRIPTION DRUG COMBIVIR lamivudine and zidovudine TABLET, FILM COATED ORAL 20130715 NDA NDA020857 REMEDYREPACK INC. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 24236-389_7c67a9da-f505-4624-ba43-adb4de65ce3a 24236-389 HUMAN PRESCRIPTION DRUG COMBIVIR lamivudine and zidovudine TABLET, FILM COATED ORAL 20130311 NDA NDA020857 REMEDYREPACK INC. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 24236-404_35d824dc-1906-43a7-b898-92feda522088 24236-404 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20111213 ANDA ANDA060704 REMEDYREPACK INC. TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 24236-404_8e3647f7-a669-48c9-9d18-b2b9eef610dd 24236-404 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride TETRACYCLINE HYDROCHLORIDE CAPSULE ORAL 20120828 ANDA ANDA075659 REMEDYREPACK INC. TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 24236-410_0497f5e6-0d99-4a05-bc7c-04e3a3d0ff01 24236-410 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130827 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 24236-412_3d96bf12-b2ae-4699-a782-7b0f2f3a7e97 24236-412 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130919 ANDA ANDA077321 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 24236-412_b9058bde-8d09-4971-93a4-78d8dc4501f7 24236-412 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20140416 ANDA ANDA077321 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 24236-418_758e795f-2588-4610-8b0a-3730b9f06c48 24236-418 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20141014 ANDA ANDA085162 REMEDYREPACK INC. PREDNISONE 10 mg/1 24236-418_7adc09e6-3b9d-4d0d-93a8-ede0b38a2c5f 24236-418 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20141020 ANDA ANDA085162 REMEDYREPACK INC. PREDNISONE 10 mg/1 24236-418_c5e2a4b4-0057-424f-ab92-dbfdf581e53c 24236-418 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140206 ANDA ANDA085162 REMEDYREPACK INC. PREDNISONE 10 mg/1 24236-418_d2025858-d0a0-44c3-af04-3062a0f09857 24236-418 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20141020 ANDA ANDA085162 REMEDYREPACK INC. PREDNISONE 10 mg/1 24236-428_93e75fd4-1e7f-4532-a133-a8cbed68559b 24236-428 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130514 ANDA ANDA076704 REMEDYREPACK INC. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 24236-428_fa7ff944-b34c-4356-adb2-f02b219c5930 24236-428 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130318 ANDA ANDA076704 REMEDYREPACK INC. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 24236-432_8d07b2a3-3ce4-4e74-8743-36a2cfe09803 24236-432 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE TABLET ORAL 20120827 ANDA ANDA089883 REMEDYREPACK INC. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 24236-439_3ac4c60a-fc78-4f50-bffc-8725ed05d838 24236-439 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130214 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 24236-448_aad0252b-b55b-4da3-a2ac-443ffe521dee 24236-448 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20130422 ANDA ANDA076048 REMEDYREPACK INC. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 24236-453_4d0c77e0-290f-4299-96ab-16b9516a0670 24236-453 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 20131008 ANDA ANDA087128 REMEDYREPACK INC. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 24236-466_48cd1258-dd1e-45d4-ac7f-b191bdb6bb63 24236-466 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20130226 ANDA ANDA070974 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 24236-476_52fa7ed4-2a11-4bf4-b300-f68e317f2dce 24236-476 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130315 ANDA ANDA074984 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 24236-484_a3b78709-d129-43e4-bea7-78f45832422b 24236-484 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET ORAL 20111019 ANDA ANDA040226 REMEDYREPACK INC. PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 24236-485_f75fd2b3-7013-4028-841b-e8a84eb03faa 24236-485 HUMAN PRESCRIPTION DRUG Metoclopramide metoclopramide TABLET ORAL 20130319 ANDA ANDA077878 REMEDYREPACK INC. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 24236-493_1b2c4eb9-d5ee-4942-99a9-d5bafebe7a90 24236-493 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20130523 ANDA ANDA075580 REMEDYREPACK INC. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 24236-496_4ee7fb47-2361-4c23-a73d-f410fd2b2f24 24236-496 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20130327 ANDA ANDA040337 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 24236-516_f4742d45-2143-4bc6-9468-b76d72d5a671 24236-516 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20130521 ANDA ANDA076045 REMEDYREPACK INC. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 24236-543_3092d2b2-d13d-4def-be18-ff039a425bab 24236-543 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET ORAL 20111213 ANDA ANDA075584 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 24236-551_4ed79923-61cc-45f0-808d-8cb91f2a055a 24236-551 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20130405 ANDA ANDA071655 REMEDYREPACK INC. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 24236-558_f84c57aa-6b5c-4a20-922b-2773ccf99023 24236-558 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20130318 ANDA ANDA089097 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 24236-572_f4038e62-f8b6-4221-a1c5-84c58b7c76b7 24236-572 HUMAN PRESCRIPTION DRUG Metronidazole METRONIDAZOLE TABLET ORAL 20120822 ANDA ANDA070033 REMEDYREPACK INC. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 24236-577_0f9e5b6e-59d8-41ba-b7bc-da25bad317e9 24236-577 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20130726 ANDA ANDA076899 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 24236-577_2b041e71-d660-4ce7-b4ad-957029278a64 24236-577 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20130515 ANDA ANDA076899 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 24236-577_7b4d93e2-84ed-40c6-9dbb-f709aded7c0d 24236-577 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20130726 ANDA ANDA076899 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 24236-577_b68ca911-a05d-4d70-b9f9-2ae0c726f31b 24236-577 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20130726 ANDA ANDA076899 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 24236-577_ed4a086f-52f3-491b-a3d5-9bdbb9a04662 24236-577 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET ORAL 20120828 ANDA ANDA076899 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 24236-581_8391fa81-b07f-4f23-a8c1-27cc6bd3ef5c 24236-581 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET ORAL 20100804 ANDA ANDA084113 REMEDYREPACK INC. CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 24236-583_29d5fef3-5802-4568-941f-867f78d85d73 24236-583 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20130318 ANDA ANDA076001 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 24236-584_42459806-e31c-441b-bb2a-9627e60e8054 24236-584 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20130318 ANDA ANDA073192 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 24236-584_46e56371-1e4f-464f-abd1-3c62c6c28a4c 24236-584 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20131202 ANDA ANDA073192 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 24236-584_5774ca1e-ce0d-421d-9083-7d35b154e78f 24236-584 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20130924 ANDA ANDA073192 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 24236-584_c2983798-4451-4572-aa34-2199e50ed7e6 24236-584 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20140224 ANDA ANDA073192 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 24236-584_f5cec097-933e-4d67-87f0-ecf6637b6a2a 24236-584 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20130924 ANDA ANDA073192 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 24236-586_9b194ea8-7c7f-4714-a763-43ec00b51dc9 24236-586 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130228 NDA NDA019123 REMEDYREPACK INC. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 24236-590_3e26c7f4-c2eb-4836-b100-28976596a009 24236-590 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20130227 ANDA ANDA074578 REMEDYREPACK INC. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 24236-590_fab10392-424f-4bd0-add5-5a8da40f05a4 24236-590 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20130828 ANDA ANDA074556 REMEDYREPACK INC. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 24236-594_a4f972d8-b8cd-4bb3-9add-bec4c7dc95b8 24236-594 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20131203 ANDA ANDA071611 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 24236-594_f145f11e-bb9a-4829-b413-2b0933cfacbe 24236-594 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20141216 ANDA ANDA071611 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 24236-594_f8de05bd-aa5c-40ea-9a6c-92689ea1a70e 24236-594 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20130313 ANDA ANDA071611 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 24236-602_f2e8c37e-b73d-4360-80b3-d06c4198e21c 24236-602 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20130327 ANDA ANDA071524 REMEDYREPACK INC. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 24236-608_4084da4c-619e-4331-9fb9-bf8f5ec6fcfc 24236-608 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20130315 ANDA ANDA075483 REMEDYREPACK INC. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 24236-609_7065d910-8723-48a4-8d80-19798d38b750 24236-609 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20130729 ANDA ANDA076003 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 24236-609_9f34fbe6-b2a6-4bd0-8e1f-8243459b14f9 24236-609 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20111205 ANDA ANDA076003 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 24236-609_e8acb295-f82b-492f-8848-41af3eaa6f46 24236-609 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20131112 ANDA ANDA076003 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 24236-609_f626bc03-2b5e-45ee-b06d-6628b7cde087 24236-609 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20130731 ANDA ANDA076003 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 24236-614_6045ed66-c3ed-4dee-82da-4a96d1834ff1 24236-614 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130301 ANDA ANDA040412 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 24236-615_fc1d6d25-c753-4990-82ff-c864d3c2e96d 24236-615 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130520 ANDA ANDA078402 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 24236-621_74fe6cdb-e991-4cf6-8e46-4ce03048f2ac 24236-621 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 20130318 ANDA ANDA070624 REMEDYREPACK INC. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24236-624_2fe3b7b7-de7e-473e-ac06-05f89965734d 24236-624 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20130327 ANDA ANDA071523 REMEDYREPACK INC. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 24236-624_c8151233-e6be-4efe-9750-fc3971ad18c2 24236-624 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20131004 ANDA ANDA071523 REMEDYREPACK INC. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 24236-625_187fec5b-20ab-414b-a609-0d8ccfef0936 24236-625 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130403 ANDA ANDA088832 REMEDYREPACK INC. PREDNISONE 10 mg/1 24236-625_24d8ba01-420a-41f0-b2c6-edb2ba27bd56 24236-625 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130403 ANDA ANDA088832 REMEDYREPACK INC. PREDNISONE 10 mg/1 24236-625_fed78b8d-1f10-493b-b764-b8c2147c9502 24236-625 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130320 ANDA ANDA088832 REMEDYREPACK INC. PREDNISONE 10 mg/1 24236-628_5217e798-cd56-46f3-9ad1-4052f1a07f8e 24236-628 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20131008 ANDA ANDA075576 REMEDYREPACK INC. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 24236-628_674a6445-e9bf-42cc-bbbd-47ffc9fd0565 24236-628 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20130408 ANDA ANDA075576 REMEDYREPACK INC. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 24236-633_2177c4f0-c048-418c-afa1-ac8799dc913b 24236-633 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20130228 ANDA ANDA077864 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 24236-634_8a7383b4-b11f-4350-94f8-d6a2c3b5ad20 24236-634 HUMAN PRESCRIPTION DRUG ALLOPURINOL ALLOPURINOL TABLET ORAL 20130111 NDA NDA018877 REMEDYREPACK INC. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 24236-641_2bcffed2-054f-41b7-94dd-1fc8e47b7ea2 24236-641 HUMAN PRESCRIPTION DRUG Acetaminophen Acetaminophen TABLET ORAL 20110309 ANDA ANDA075659 REMEDYREPACK INC. ACETAMINOPHEN 325 mg/1 24236-652_6f32992d-67a1-41c0-a938-76a8d41b0ff4 24236-652 HUMAN PRESCRIPTION DRUG HALOPERIDOL HALOPERIDOL TABLET ORAL 20101220 ANDA ANDA071208 REMEDYREPACK INC. HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] 24236-656_1b11053f-dcdb-473d-a252-ecc0ecd19a71 24236-656 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141119 ANDA ANDA075576 REMEDYREPACK INC. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 24236-656_ffc9fa9d-3790-43a4-bb30-3b2d68333edb 24236-656 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20130319 ANDA ANDA075576 REMEDYREPACK INC. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 24236-657_2ab03267-9498-4abc-b0cd-36a617585787 24236-657 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20130410 NDA NDA020592 REMEDYREPACK INC. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 24236-669_377b3aa7-b93d-4b85-baef-6e360b90b7fa 24236-669 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20130328 ANDA ANDA075317 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 24236-671_277e177e-7509-4d28-aa3f-4908b546f096 24236-671 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20130523 ANDA ANDA065404 REMEDYREPACK INC. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24236-671_377e7129-f491-4c7d-a5ac-bff17639ae2d 24236-671 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20130523 ANDA ANDA065404 REMEDYREPACK INC. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24236-679_0b33a312-b2db-4869-b1b7-b978c9f29bc6 24236-679 HUMAN PRESCRIPTION DRUG Intelence etravirine TABLET ORAL 20130318 NDA NDA022187 REMEDYREPACK INC. ETRAVIRINE 100 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] 24236-699_e6cd84cc-7c1f-4801-a190-5e0bed6b4a80 24236-699 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20130320 ANDA ANDA070176 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 24236-699_f2d2fda7-092c-479a-abb9-7420cdcaa0d0 24236-699 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20130624 ANDA ANDA070176 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 24236-705_c84da2e6-b653-47cc-987d-350e5749001e 24236-705 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20101209 ANDA ANDA072266 REMEDYREPACK INC. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 24236-707_bd069af5-6beb-4b67-9c13-cf3eef6cd778 24236-707 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20110406 ANDA ANDA065061 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 24236-708_4ace2487-e7be-41d7-853b-11ba078d4918 24236-708 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110927 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 24236-719_995317cb-3077-4b4c-b858-a318a1944f7e 24236-719 HUMAN PRESCRIPTION DRUG Metronidazole METRONIDAZOLE TABLET ORAL 20120910 ANDA ANDA070027 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 24236-720_b45187d2-94dc-48ec-9d64-e9454cdce801 24236-720 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130228 ANDA ANDA078402 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 24236-727_ffe5586d-9e6d-4aeb-9b88-4c2815d133da 24236-727 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET, FILM COATED ORAL 20101216 ANDA ANDA077031 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 24236-729_397dbeda-59eb-4fda-a685-2b3bf8adffdf 24236-729 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20130328 ANDA ANDA077864 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 24236-736_c5ed2509-8dc4-4db6-8ea2-5b8b3a0db6d1 24236-736 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 20130318 NDA NDA017812 REMEDYREPACK INC. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 24236-739_9497122f-d147-4a60-917f-510bd2c6bc5e 24236-739 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20130215 ANDA ANDA077864 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 24236-754_706d17b9-4482-414b-a09e-4314e9b737b2 24236-754 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20130227 ANDA ANDA076418 REMEDYREPACK INC. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 24236-759_35367983-00e4-4dc3-8381-b096ccffd730 24236-759 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20141229 ANDA ANDA078216 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 24236-760_eb361ead-eb35-4914-8dc4-c575fcfeee36 24236-760 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20101215 ANDA ANDA074253 REMEDYREPACK INC. BUSPIRONE 5 mg/1 24236-762_331ebfe3-ad85-40e7-afe2-4031deb5dceb 24236-762 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20130110 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24236-763_021eeb8c-3119-4ef5-b3d5-dbd519b9571c 24236-763 HUMAN PRESCRIPTION DRUG Pyrazinamide Pyrazinamide TABLET ORAL 20130821 ANDA ANDA080157 REMEDYREPACK INC. PYRAZINAMIDE 500 mg/1 Antimycobacterial [EPC] 24236-776_49d941c6-d246-452e-b126-1189c99075ec 24236-776 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20130320 ANDA ANDA074131 REMEDYREPACK INC. PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24236-777_2b2aee68-b4f6-46d2-ad02-b94037011723 24236-777 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20130410 NDA NDA020639 REMEDYREPACK INC. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 24236-786_4d369329-49f3-4fb9-826a-6fe41ab92bb7 24236-786 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130311 ANDA ANDA076649 REMEDYREPACK INC. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 24236-789_d56149d5-c8ff-465f-94ca-27875531f371 24236-789 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20130514 NDA NDA020639 REMEDYREPACK INC. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 24236-792_aa80d40b-62f5-4d8d-9a06-729f78aa45ad 24236-792 HUMAN PRESCRIPTION DRUG ABILIFY ABILIFY TABLET ORAL 20101213 ANDA ANDA075659 REMEDYREPACK INC. ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] 24236-805_1f22662a-2837-4c99-a9ce-75e9276d2cf0 24236-805 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130311 ANDA ANDA076649 REMEDYREPACK INC. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 24236-809_b5e7085c-791d-4f08-8216-d177d79a5676 24236-809 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20130327 ANDA ANDA040416 REMEDYREPACK INC. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 24236-811_7ce325ee-2a17-4a62-b39a-cc87a5cd0e5d 24236-811 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20130318 ANDA ANDA040350 REMEDYREPACK INC. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 24236-819_9ca14d8f-1916-435f-aa6d-acbe7a4645a8 24236-819 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20130509 NDA NDA020639 REMEDYREPACK INC. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 24236-824_11bd2d47-e073-43f2-b906-80bc54812997 24236-824 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 20130319 NDA NDA020839 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 24236-830_259132c9-d62b-4c4b-b9c7-ba15a895bc25 24236-830 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET ORAL 20110816 ANDA ANDA084115 REMEDYREPACK INC. CHLORPROMAZINE HYDROCHLORIDE 200 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 24236-837_ad79816b-6d4c-42ed-b925-a8b09799b189 24236-837 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20130510 NDA NDA021436 REMEDYREPACK INC. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] 24236-839_e2336325-6ede-4444-9d96-210e54d11cb6 24236-839 HUMAN PRESCRIPTION DRUG ABILIFY ABILIFY TABLET ORAL 20101214 ANDA ANDA075659 REMEDYREPACK INC. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] 24236-845_3f95d90a-44f6-4528-914e-c49012d2facb 24236-845 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20130410 NDA NDA021427 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 24236-846_0b4dffad-ea90-4658-8ba2-c2b5fc5d6c07 24236-846 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20101215 ANDA ANDA074253 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 10 mg/1 24236-852_7051061a-648a-4ae7-b1d5-a548ffa62acd 24236-852 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20130403 ANDA ANDA078329 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24236-855_ad709fd8-e7c7-4757-8239-ff4d449797f4 24236-855 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130318 ANDA ANDA040707 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 24236-860_94a44975-4e75-42ae-bcbb-fc44a558f0bd 24236-860 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, FILM COATED ORAL 20130328 NDA NDA020829 REMEDYREPACK INC. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 24236-875_613aa000-2bce-4176-a5b5-538d277faf42 24236-875 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130318 NDA NDA019123 REMEDYREPACK INC. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 24236-880_a930bcf5-3e01-4f0a-a52b-892034569037 24236-880 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20130326 ANDA ANDA089684 REMEDYREPACK INC. PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 24236-882_6e4b1793-e96c-45e6-ac48-9f3fee1d62f0 24236-882 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20130509 NDA NDA021411 REMEDYREPACK INC. ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 24236-883_1e8fa039-5b9f-4b1f-8b2f-b79a5c7055b9 24236-883 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20131007 ANDA ANDA076368 REMEDYREPACK INC. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 24236-887_4231f322-2489-4e5d-9ecb-f54857da87ae 24236-887 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20130320 ANDA ANDA089685 REMEDYREPACK INC. PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 24236-889_f531e70b-1a2a-4837-b57b-0db587bc6556 24236-889 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20130319 ANDA ANDA089686 REMEDYREPACK INC. PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 24236-906_a88966c4-4b24-4a93-879c-cdbbba22f407 24236-906 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET ORAL 20111115 ANDA ANDA065405 REMEDYREPACK INC. AZITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24236-908_4a162d38-dc4e-4099-ae39-fedc1ad9df2b 24236-908 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride METFORMIN HYDROCHLORIDE TABLET ORAL 20120827 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 24236-908_a4e60a37-9faa-475d-a5bf-3b8e4877e9ce 24236-908 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20130916 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 24236-908_cbd79197-6393-482b-bc49-fee3bee395dc 24236-908 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20111114 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 24236-921_bdf5f338-86cf-4417-ad5c-075af93878d9 24236-921 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20130318 ANDA ANDA076919 REMEDYREPACK INC. LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 24236-922_4e9fd752-8093-4e03-837a-8d72c3bfa876 24236-922 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20130506 ANDA ANDA076919 REMEDYREPACK INC. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 24236-933_3cd3d999-05d3-4ed1-98b5-e67f2fef1124 24236-933 HUMAN PRESCRIPTION DRUG DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE ORAL 20101217 ANDA ANDA070791 REMEDYREPACK INC. DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 24236-943_7f9120f1-a397-4826-8394-3c27412f7fcf 24236-943 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111213 ANDA ANDA076388 REMEDYREPACK INC. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 24236-945_d0bfad49-4117-4cc4-8c21-711663068e2e 24236-945 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130422 ANDA ANDA076388 REMEDYREPACK INC. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 24236-950_14f125ed-f3a0-4e92-a48f-6355b8ea740d 24236-950 HUMAN PRESCRIPTION DRUG BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET ORAL 20101215 ANDA ANDA075385 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 15 mg/1 24236-960_0e37d184-3aa7-4bbd-8935-7be054ec9ea6 24236-960 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20140618 ANDA ANDA080936 REMEDYREPACK INC. ISONIAZID 100 mg/1 Antimycobacterial [EPC] 24236-960_4d3dfceb-4e02-4f34-8f65-2d75cfc95da4 24236-960 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20140618 ANDA ANDA080936 REMEDYREPACK INC. ISONIAZID 100 mg/1 Antimycobacterial [EPC] 24236-975_22c511f9-05b1-4483-a6a0-30c91c5bf858 24236-975 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20130514 NDA NDA020592 REMEDYREPACK INC. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 24236-988_709b2cc4-97bc-40f0-b406-e9f537d82cbe 24236-988 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20130408 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 24236-991_5590227a-6a82-4346-9f86-780eff1b5cbb 24236-991 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20130409 NDA NDA021436 REMEDYREPACK INC. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] 24236-991_d828b59c-7bf6-41f7-a126-8d981c18de00 24236-991 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20130409 NDA NDA021436 REMEDYREPACK INC. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] 24236-994_2920577d-8b82-49cd-b33f-39ed046c9ee4 24236-994 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20120710 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 24236-995_14bb3fab-b5f4-4bee-b221-4c7207e74c48 24236-995 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20120112 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24236-995_1dfe87a9-9733-405d-8afd-bd69a48495ed 24236-995 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20130715 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24236-995_3f9c9f2c-34c0-401c-96e4-275b924bdad6 24236-995 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20130712 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24236-995_4ad276ff-0f0e-4691-abce-c1a94a860388 24236-995 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20130715 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24236-995_caa00f22-478f-4e57-81f5-63138940fc86 24236-995 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20131011 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24236-995_e4357247-18fa-49f2-8957-2be221ba17ed 24236-995 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20130725 ANDA ANDA078250 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 24236-997_6e61e724-4293-4fb3-b8c9-d3e47b83591d 24236-997 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20130708 NDA NDA020592 REMEDYREPACK INC. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 24275-0185_7fd55db9-1362-4b1d-9e2a-8a97c034f7fd 24275-0185 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F18 INJECTION INTRAVENOUS 20111204 ANDA ANDA203902 UCSF Radiopharmaceutical Facility FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 24275-0285_338dcd9a-0735-4a35-b8d2-55735114fe6e 24275-0285 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F-18 INJECTION INTRAVENOUS 20091101 ANDA ANDA204437 UCSF Radiopharmaceutical Facility SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 24275-0385_4b973cd4-37c3-4107-b37c-ccca43795974 24275-0385 HUMAN PRESCRIPTION DRUG Ammonia N 13 NH3N13 INJECTION INTRAVENOUS 20081106 ANDA ANDA204496 UCSF Radiopharmaceutical Facility AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 24286-1520_3a3e8d1f-2a67-426b-9620-ed4484d1b5ce 24286-1520 HUMAN OTC DRUG Bactimicina for Sore Throat BENZOCAINE LOZENGE ORAL 20110524 OTC MONOGRAPH NOT FINAL part356 DLC Laboratories, Inc. BENZOCAINE 15 mg/1 24286-1521_4717b40c-422d-45e7-b366-df2ebb217fd9 24286-1521 HUMAN OTC DRUG De La Cruz Camphor CAMPHOR OINTMENT TOPICAL 20120726 OTC MONOGRAPH NOT FINAL part348 DLC Laboratories, Inc. CAMPHOR (SYNTHETIC) 11 g/100g 24286-1523_e7908a80-3f51-4414-a5c8-35a291fb67b0 24286-1523 HUMAN OTC DRUG De La Cruz Desempacho SODIUM BICARBONATE LIQUID ORAL 20120806 OTC MONOGRAPH FINAL part331 DLC LABORATORIES, INC. SODIUM BICARBONATE 525 mg/15mL 24286-1525_badd916c-2209-4ea6-b0c2-f62445b74ef2 24286-1525 HUMAN OTC DRUG De La Cruz Sulfur Acne Medication SULFUR OINTMENT TOPICAL 20120727 OTC MONOGRAPH FINAL part333D DLC Laboratories, Inc. SULFUR 10 g/100g 24286-1526_923ac6fc-7f92-4c9a-8fda-e219082074ca 24286-1526 HUMAN OTC DRUG De La Cruz Castor Oil CASTOR OIL OIL ORAL 20120727 OTC MONOGRAPH NOT FINAL part334 DLC Laboratories, Inc. CASTOR OIL 1 g/mL 24286-1531_48e91fa5-4b1b-47c6-ae23-a32caf78465d 24286-1531 HUMAN OTC DRUG DE LA CRUZ GENTIAN VIOLET GENTIAN VIOLET TINCTURE TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E DLC Laboratories, Inc. GENTIAN VIOLET 1 g/100mL 24286-1532_8c9ecb50-d598-4055-93f7-64a9f5b0b54a 24286-1532 HUMAN OTC DRUG Tincture Merthiolate BENZALKONIUM CHLORIDE TINCTURE TOPICAL 20130322 OTC MONOGRAPH NOT FINAL part333A DLC Laboratories, Inc BENZALKONIUM CHLORIDE 1.3 mg/mL 24286-1533_af97e5eb-3666-46c7-be59-a158127dd385 24286-1533 HUMAN OTC DRUG QUITA COLICOS GAS RELIEF DROPS Simethicone LIQUID ORAL 20140318 OTC MONOGRAPH FINAL part332 DLC Laboratories, Inc. DIMETHICONE 20 mg/.3mL 24286-1534_ef8b704e-0254-403c-a686-a3a03982a97d 24286-1534 HUMAN OTC DRUG VAPOREX CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, and MENTHOL OINTMENT TOPICAL 20130312 OTC MONOGRAPH FINAL part341 DLC Laboratories, Inc. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 g/100g; g/100g; g/100g 24286-1537_133d1894-7fe6-4651-b2e1-6187af33f07f 24286-1537 HUMAN OTC DRUG DE LA CRUZ SODIUM BICARBONATE ANTACID SODIUM BICARBONATE POWDER ORAL 20130925 OTC MONOGRAPH FINAL part331 DLC Laboratories, Inc. SODIUM BICARBONATE 2.6 g/2.6g 24286-1546_395166d9-fbad-41f0-a96a-1c9f0c0679e5 24286-1546 HUMAN OTC DRUG BACTIMICINA COUGH AND COLD DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE SOLUTION ORAL 20131106 OTC MONOGRAPH FINAL part341 DLC Laboratories, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 24286-1549_a34907a5-e9aa-4acd-a7ef-37080c6b5443 24286-1549 HUMAN OTC DRUG Bactimicina Allergy Loratadine TABLET ORAL 20091021 ANDA ANDA076134 DLC Laboratories, Inc. LORATADINE 10 mg/1 24286-1550_fda5cbd7-b95e-4ba6-90ad-c8d8611ea8ed 24286-1550 HUMAN OTC DRUG Bactimicina Childrens Pain and Fever ACETAMINOPHEN LIQUID ORAL 20091021 OTC MONOGRAPH FINAL part343 DLC Laboratories, Inc. ACETAMINOPHEN 160 mg/5mL 24286-1551_e6ea48fa-3488-475a-b8b1-63f76579b136 24286-1551 HUMAN OTC DRUG Bactimicina Childrens Cough and Cold CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20091023 OTC MONOGRAPH FINAL part341 DLC Laboratories, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 1; 7.5 mg/5mL; mg/5mL 24286-1552_83f516d6-7aa5-482f-a597-77d527f89bea 24286-1552 HUMAN OTC DRUG PURGASOL Sennosides Docusate Sodium TABLET ORAL 20091116 OTC MONOGRAPH NOT FINAL part334 DLC Laboratories, Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 24286-1553_2c9e57aa-afcd-4916-be9c-455316e968ba 24286-1553 HUMAN OTC DRUG De La Cruz Mercurochrome BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE LIQUID TOPICAL 20110630 OTC MONOGRAPH NOT FINAL part333A DLC Laboratories, Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .13; 2.5 mL/100mL; mL/100mL 24286-1554_907250f2-710d-4a33-91d4-ee313c8f2802 24286-1554 HUMAN OTC DRUG Earths Care Pain Relieving CAMPHOR, MENTHOL, METHYL SALICYLATE OINTMENT TOPICAL 20111129 OTC MONOGRAPH NOT FINAL part348 DLC Laboratories, Inc. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 4; 10; 15 g/100g; g/100g; g/100g 24286-1555_902c4545-d477-4844-ae61-776672a27a47 24286-1555 HUMAN OTC DRUG Earths Care Arnica Compound CAMPHOR OINTMENT TOPICAL 20120222 OTC MONOGRAPH NOT FINAL part348 DLC Laboratories, Inc. CAMPHOR (NATURAL) 3 g/100g 24286-1556_60d82572-f32f-4d16-a01d-861a0869cae8 24286-1556 HUMAN OTC DRUG Earths Care Acne Treatment Mask SULFUR CREAM TOPICAL 20130118 OTC MONOGRAPH FINAL part333D DLC Laboratories, Inc. SULFUR 5 g/100g 24286-1557_ed627ee7-f85b-4b09-8975-43481b80c815 24286-1557 HUMAN OTC DRUG Earths Care Acne Spot Treatment SULFUR CREAM TOPICAL 20130118 OTC MONOGRAPH FINAL part333D DLC Laboratories, Inc. SULFUR 10 g/100g 24286-1558_770e3b75-8a06-4297-9baf-9782d98581ce 24286-1558 HUMAN OTC DRUG EARTHS CARE ANTI-ITCH CAMPHOR (NATURAL), MENTHOL CREAM TOPICAL 20131030 OTC MONOGRAPH NOT FINAL part348 DLC Laboratories, Inc. CAMPHOR (NATURAL); MENTHOL .5; 1 g/100g; g/100g 24286-1559_413352a5-6cc0-4553-be42-05e5ae4b05c9 24286-1559 HUMAN OTC DRUG EARTHS CARE ARTHRITIS CREAM CAPSAICIN CREAM TOPICAL 20130925 OTC MONOGRAPH NOT FINAL part348 DLC Laboratories, Inc. CAPSAICIN .1 g/100g 24286-1560_b1f5b320-98db-4c06-89a6-b0767da14385 24286-1560 HUMAN OTC DRUG Maximum Strength Hydrocortisone HYDROCORTISONE OINTMENT TOPICAL 20130322 OTC MONOGRAPH NOT FINAL part348 DLC Laboratories, Inc HYDROCORTISONE 1 g/100g 24286-1561_d2b81f9f-5c9a-408e-8a70-ccc5f9925848 24286-1561 HUMAN OTC DRUG Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20110201 OTC MONOGRAPH FINAL part358G DLC Laboratories, Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 24286-1562_336e3903-7466-4904-a0fa-ca0e86fd1489 24286-1562 HUMAN OTC DRUG Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20110201 OTC MONOGRAPH FINAL part358G DLC Laboratories, Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 24286-1563_774a3e7a-2998-42a8-ad97-6508a6c6f265 24286-1563 HUMAN OTC DRUG EARTHS CARE MUSCLE AND JOINT RUB camphor OINTMENT TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part348 DLC Laboratories, Inc. CAMPHOR (NATURAL) 3 g/100g 24286-5191_7374d2b2-bd66-4f23-95bb-4d7e6a3cf71f 24286-5191 HUMAN OTC DRUG Colirio Ocusan Polyethlene glycol 400 Tetrahydrozoline HCl LIQUID OPHTHALMIC 20110831 OTC MONOGRAPH FINAL part349 DLC Laboratories, Inc. POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE 10; .5 mg/mL; mg/mL 24286-5292_852c9a13-822a-4990-872f-ba161c1dc56e 24286-5292 HUMAN OTC DRUG Tears lubricant glycerin, hypromellose, polyethylene glycol 400 LIQUID OPHTHALMIC 20110831 OTC MONOGRAPH FINAL part349 DLC Laboratories, Inc. GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2; 2; 10 mg/mL; mg/mL; mg/mL 24306-123_2680d774-848e-4be0-936d-3762a04b93dd 24306-123 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS Air Systems of Illinois, Inc. OXYGEN 99 L/100L 24319-0001_08a259ad-7b46-49c0-b312-bd8a019bc224 24319-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060201 UNAPPROVED MEDICAL GAS Homeside Healthcare, Inc. OXYGEN 99 L/100L 24330-110_e10bcfb8-079f-4033-a805-35d03c7ebd64 24330-110 HUMAN OTC DRUG First Degree Calendula Officinalis, Echinacea Angustifolia, Cantharis Vesicatoria TINCTURE TOPICAL 20070101 UNAPPROVED HOMEOPATHIC The Akshay Wellness Group, Inc. CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; LYTTA VESICATORIA 1; 1; 3 [hp_Q]/.21g; [hp_Q]/.21g; [hp_X]/1.68g 24330-111_8bbc5057-7e59-4b84-ab30-b775b1a18dd3 24330-111 HUMAN OTC DRUG First Degree Burn benzocaine, triclosan SPRAY TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part348 The Akshay Wellness Group, Inc. BENZOCAINE; TRICLOSAN 200; 1.3 mg/mL; mg/mL 24330-210_e42cf212-6056-42f6-9809-d2ae4f8f5f23 24330-210 HUMAN OTC DRUG SunBurnt Calendula Officinalis, Echinacea Angustifolia, Cantharis Vesicatoria TINCTURE TOPICAL 20070101 UNAPPROVED HOMEOPATHIC The Akshay Wellness Group, Inc. CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; LYTTA VESICATORIA 1; 1; 3 [hp_Q]/.1g; [hp_Q]/.1g; [hp_X]/.1g 24330-410_551e6cce-7adc-4e98-baff-2703b83d7526 24330-410 HUMAN OTC DRUG Welmedix HomeCare PRO Extra Strength Rapid Rash Relief Petrolatum, Zinc Oxide CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part347 The Akshay Wellness Group, Inc. PETROLATUM; ZINC OXIDE 49; 15 g/100g; g/100g 24330-411_286a2004-09c3-44f0-b149-225f533613f7 24330-411 HUMAN OTC DRUG Welmedix HomeCare PRO 2-in-1 Antifungal and Skin Protectant Miconazole Nitrate OINTMENT TOPICAL 20130401 OTC MONOGRAPH FINAL part333C The Akshay Wellness Group, Inc. MICONAZOLE NITRATE 2 g/100g 24330-412_6e8d7151-c7fc-4b8f-9343-4a9f0f4e37cf 24330-412 HUMAN OTC DRUG Welmedix HomeCare PRO Fragile Skin Protectant Petrolatum OINTMENT TOPICAL 20130401 OTC MONOGRAPH FINAL part347 The Akshay Wellness Group, Inc. PETROLATUM 42 g/100g 24338-010_c1639413-d804-4fe5-963d-fa7c4bd63225 24338-010 HUMAN PRESCRIPTION DRUG BiDil Hydralazine hydrochloride and Isosorbide dinitrate TABLET, FILM COATED ORAL 20121205 NDA NDA020727 Arbor Pharmaceuticals, Inc. HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE 37.5; 20 mg/1; mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 24338-050_621009f3-a208-4109-916c-a79d9c2c008c 24338-050 HUMAN PRESCRIPTION DRUG Gliadel carmustine WAFER INTRACAVITARY 20121213 NDA NDA020637 Arbor Pharmaceuticals CARMUSTINE 7.7 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 24338-100_cd2eb178-1163-4509-b9dc-32d7c16290c6 24338-100 HUMAN PRESCRIPTION DRUG E.E.S 400 Erythromycin Ethylsuccinate TABLET ORAL 20110503 ANDA ANDA061905 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 400 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24338-102_72334fa3-04c6-4bee-a3d9-15a14bffafaf 24338-102 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin TABLET, FILM COATED ORAL 20110906 ANDA ANDA061621 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24338-104_72334fa3-04c6-4bee-a3d9-15a14bffafaf 24338-104 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin TABLET, FILM COATED ORAL 20110906 ANDA ANDA061621 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24338-106_8bb04897-b479-4077-8610-ff24ff4cdbee 24338-106 HUMAN PRESCRIPTION DRUG Erythrocin Stearate ERYTHROMYCIN STEARATE TABLET, FILM COATED ORAL 20110801 ANDA ANDA060359 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN STEARATE 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24338-110_caa1bc9f-962a-409e-8d3f-83115259b1c3 24338-110 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN ETHYLSUCCINATE Erythromycin Ethylsuccinate TABLET ORAL 20111003 ANDA ANDA061904 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 400 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24338-112_2742a78f-022f-4c97-be6f-f97c4a7c4527 24338-112 HUMAN PRESCRIPTION DRUG PCE ERYTHROMYCIN ETHYLSUCCINATE TABLET ORAL 20111005 NDA NDA050611 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24338-114_2742a78f-022f-4c97-be6f-f97c4a7c4527 24338-114 HUMAN PRESCRIPTION DRUG PCE ERYTHROMYCIN ETHYLSUCCINATE TABLET ORAL 20111005 NDA NDA050611 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24338-120_98e41f94-ac95-40e6-b7f5-39dc5e696a9a 24338-120 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN Erythromycin CAPSULE, DELAYED RELEASE ORAL 20120110 ANDA ANDA062746 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24338-122_05c654d8-f2f0-4a50-8369-336d70946d15 24338-122 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24338-124_05c654d8-f2f0-4a50-8369-336d70946d15 24338-124 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24338-126_05c654d8-f2f0-4a50-8369-336d70946d15 24338-126 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24338-130_97846f49-4484-46c0-9093-ceaaa1a81cc8 24338-130 HUMAN PRESCRIPTION DRUG Ery-Ped Erythromycin Ethylsuccinate SUSPENSION ORAL 20120614 NDA NDA050207 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 400 mg/5mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24338-132_97846f49-4484-46c0-9093-ceaaa1a81cc8 24338-132 HUMAN PRESCRIPTION DRUG Ery-Ped Erythromycin Ethylsuccinate SUSPENSION ORAL 20110705 NDA NDA050207 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 200 mg/5mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24338-134_cd2eb178-1163-4509-b9dc-32d7c16290c6 24338-134 HUMAN PRESCRIPTION DRUG E.E.S Erythromycin Ethylsuccinate GRANULE, FOR SUSPENSION ORAL 20110418 NDA NDA050207 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 200 mg/5mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24338-136_cd2eb178-1163-4509-b9dc-32d7c16290c6 24338-136 HUMAN PRESCRIPTION DRUG E.E.S Erythromycin Ethylsuccinate GRANULE, FOR SUSPENSION ORAL 20110418 NDA NDA050207 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 200 mg/5mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 24338-200_287cc0f1-6111-44db-8657-525a62a4397c 24338-200 HUMAN PRESCRIPTION DRUG Nymalize nimodipine SOLUTION ORAL 20130603 NDA NDA203340 Arbor Pharmaceuticals NIMODIPINE 60 mg/20mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 24338-300_1f0668f8-7308-4304-92fd-1154f6d448a9 24338-300 HUMAN PRESCRIPTION DRUG Nitrolingual Pumpspray nitroglycerin SPRAY, METERED ORAL 20000201 NDA NDA018705 Arbor Pharmaceuticals, Inc. NITROGLYCERIN 400 ug/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 24338-320_d78ca693-f071-4cc1-896a-7c1805c3e3d5 24338-320 HUMAN PRESCRIPTION DRUG Pediaderm AF Nystatin KIT 20110101 ANDA ANDA062364 Arbor Pharmaceuticals, Inc. 24338-416_39d22315-b861-402b-a50e-f5da6a3d75dd 24338-416 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19971126 ANDA ANDA040039 Arbor Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE 1 mg/g 24338-420_64938885-cae4-417b-bb34-3aadd8e0e3c4 24338-420 HUMAN PRESCRIPTION DRUG Pediaderm HC Hydrocortisone KIT 20091102 ANDA ANDA083231 Arbor Pharmaceuticals, Inc. 24338-430_6c8f74e8-91c7-4670-8034-a57cb6ea8985 24338-430 HUMAN PRESCRIPTION DRUG Pediaderm TA Triamcinolone Acetonide CREAM TOPICAL 20100901 ANDA ANDA040039 Arbor Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 24338-516_d09c0079-fa57-43fc-bba1-b9846920ac94 24338-516 HUMAN PRESCRIPTION DRUG Nystatin Nystatin CREAM TOPICAL 19930128 ANDA ANDA064022 Arbor Pharmaceuticals Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 24338-520_cde49b4a-7d7e-49b8-8d93-51b7c917055b 24338-520 HUMAN PRESCRIPTION DRUG Pediaderm TA Triamcinolone Acetonide KIT 20110101 ANDA ANDA040039 Arbor Pharmaceuticals, Inc. 24338-602_935d5be5-4713-4114-8c99-a50c953b1fee 24338-602 HUMAN PRESCRIPTION DRUG Fluor-a-day Sodium fluoride and Xylitol TABLET, CHEWABLE ORAL 20100815 UNAPPROVED DRUG OTHER Arbor Pharmaceuticals, Inc. SODIUM FLUORIDE; XYLITOL .25; 236.79 mg/1; mg/1 24338-611_935d5be5-4713-4114-8c99-a50c953b1fee 24338-611 HUMAN PRESCRIPTION DRUG Fluor-a-day Sodium fluoride and Xylitol TABLET, CHEWABLE ORAL 20100815 UNAPPROVED DRUG OTHER Arbor Pharmaceuticals, Inc. SODIUM FLUORIDE; XYLITOL .5; 236.79 mg/1; mg/1 24338-622_935d5be5-4713-4114-8c99-a50c953b1fee 24338-622 HUMAN PRESCRIPTION DRUG Fluor-a-day Sodium fluoride and Xylitol TABLET, CHEWABLE ORAL 20100815 UNAPPROVED DRUG OTHER Arbor Pharmaceuticals, Inc. SODIUM FLUORIDE; XYLITOL 1; 236.79 mg/1; mg/1 24338-656_935d5be5-4713-4114-8c99-a50c953b1fee 24338-656 HUMAN PRESCRIPTION DRUG Fluor-a-day Sodium fluoride SOLUTION/ DROPS ORAL 20100815 UNAPPROVED DRUG OTHER Arbor Pharmaceuticals, Inc. SODIUM FLUORIDE 5.56 mg/mL 24338-850_64ab9a82-6695-4d23-a26c-50e803dd6ca3 24338-850 HUMAN PRESCRIPTION DRUG Zenzedi Dextroamphetamine Sulfate TABLET ORAL 20130531 ANDA ANDA090533 Arbor Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 2.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 24338-851_64ab9a82-6695-4d23-a26c-50e803dd6ca3 24338-851 HUMAN PRESCRIPTION DRUG Zenzedi Dextroamphetamine Sulfate TABLET ORAL 20130531 ANDA ANDA090533 Arbor Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 24338-852_64ab9a82-6695-4d23-a26c-50e803dd6ca3 24338-852 HUMAN PRESCRIPTION DRUG Zenzedi Dextroamphetamine Sulfate TABLET ORAL 20130531 ANDA ANDA090533 Arbor Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 7.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 24338-853_64ab9a82-6695-4d23-a26c-50e803dd6ca3 24338-853 HUMAN PRESCRIPTION DRUG Zenzedi Dextroamphetamine Sulfate TABLET ORAL 20130531 ANDA ANDA090533 Arbor Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 24338-854_64ab9a82-6695-4d23-a26c-50e803dd6ca3 24338-854 HUMAN PRESCRIPTION DRUG Zenzedi Dextroamphetamine Sulfate TABLET ORAL 20140501 ANDA ANDA090533 Arbor Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 24338-855_64ab9a82-6695-4d23-a26c-50e803dd6ca3 24338-855 HUMAN PRESCRIPTION DRUG Zenzedi Dextroamphetamine Sulfate TABLET ORAL 20140501 ANDA ANDA090533 Arbor Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 24338-856_64ab9a82-6695-4d23-a26c-50e803dd6ca3 24338-856 HUMAN PRESCRIPTION DRUG Zenzedi Dextroamphetamine Sulfate TABLET ORAL 20140501 ANDA ANDA090533 Arbor Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 24357-701_f606ea33-38f7-4252-b8f0-c98d4d887770 24357-701 HUMAN OTC DRUG Anecream Lidocaine 4% CREAM TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part348 Focus Health Group LIDOCAINE 4 g/100g 24357-702_34797682-67f4-487f-b00c-aff9fee9c6a6 24357-702 HUMAN OTC DRUG Anecream 5 Lidocaine 5% CREAM TOPICAL 20111220 OTC MONOGRAPH FINAL part346 Focus Health Group LIDOCAINE 5 g/100g 24385-001_56dd4269-4c74-4815-927d-1ee4b38f59f7 24385-001 HUMAN OTC DRUG good neighbor pharmacy 8 hour pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050831 ANDA ANDA075077 Amerisource Bergen ACETAMINOPHEN 650 mg/1 24385-004_d4563b79-d812-494f-84dc-cf913b8ebf18 24385-004 HUMAN OTC DRUG Motion Sickness Relief Dimenhydrinate TABLET ORAL 20100709 OTC MONOGRAPH FINAL part336 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 DIMENHYDRINATE 50 mg/1 24385-005_068cab9b-3f47-48c8-b5f9-914a63a473b7 24385-005 HUMAN OTC DRUG Good Neighbor Pharmacy Day Time acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20060720 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 24385-009_3479ba9d-99ed-4a4c-8c13-66c341a77a89 24385-009 HUMAN OTC DRUG Good Neighbor Pharmacy ibuprofen childrens Ibuprofen LIQUID ORAL 19940809 ANDA ANDA074937 Amerisource Bergen IBUPROFEN 100 mg/5mL 24385-011_f130ce02-1f83-4eec-9487-bbd2b8195740 24385-011 HUMAN OTC DRUG Good Neighbor pharmacy muscle rub Menthol, Methyl salicylate CREAM TOPICAL 20060117 OTC MONOGRAPH NOT FINAL part348 Amerisource Bergen MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g 24385-013_fa417d3e-3384-469e-ba09-97da0656e498 24385-013 HUMAN OTC DRUG Urinary Pain Relief Phenazopyridine Hydrochloride TABLET ORAL 20100708 UNAPPROVED DRUG OTHER AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 PHENAZOPYRIDINE 95 mg/1 24385-014_3e55a8aa-a76f-4c5d-b986-c4496b265d9b 24385-014 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090729 OTC MONOGRAPH NOT FINAL part356 Good Neighbor Pharmacy HYDROGEN PEROXIDE 2.65 mL/100mL 24385-016_36ad3f40-d559-44f0-8e88-bd2abc321b13 24385-016 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090918 OTC MONOGRAPH FINAL part335 Good Neighbor Pharmacy BISMUTH SUBSALICYLATE 262 mg/15mL 24385-021_a4313d5d-e549-49bf-b4d5-34b2a7d62c8b 24385-021 HUMAN OTC DRUG Good Neighbor Pharmacy Hydrocortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 AmerisourceBergen HYDROCORTISONE 1 g/100g 24385-026_b0a9862d-b084-421e-9038-4a149ce14e30 24385-026 HUMAN OTC DRUG Good Neighbor Pharmacy Mucus Relief DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 AmerisourceBergen Drug Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 24385-028_b6b01b95-6003-4c9d-a7c0-01dc0fc6ad7c 24385-028 HUMAN OTC DRUG Good Neighbor Pharmacy Aspirin Aspirin TABLET, CHEWABLE ORAL 19930319 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ASPIRIN 81 mg/1 24385-032_bd8164cd-c58f-4f72-99a2-5fdb797521a7 24385-032 HUMAN OTC DRUG Tolnaftate Antifungal Tolnaftate CREAM TOPICAL 20060217 OTC MONOGRAPH FINAL part333C Amerisource Bergen TOLNAFTATE 10 mg/g 24385-035_a77f3142-3ec0-4037-b134-a4f2261aed21 24385-035 HUMAN OTC DRUG good neighbor pharmacy night time Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20060419 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 24385-036_e5c1bd96-d27d-49c1-b3b8-eee53a145ef5 24385-036 HUMAN OTC DRUG good neighbor pharmacy day time cold and flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20120802 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 24385-039_ac9975a9-2b59-440f-a8d7-cad5dc9cf016 24385-039 HUMAN OTC DRUG good neighbor pharmacy enema Saline ENEMA RECTAL 20091124 OTC MONOGRAPH NOT FINAL part334 Amerisource Bergen SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 24385-052_828faf61-2440-46ec-bdff-85f08c3a64c9 24385-052 HUMAN OTC DRUG Good Neighbor Pharmacy Cold Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET ORAL 20080923 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 24385-053_49b195d0-00fe-4ea7-9483-0e71f8e9b8b4 24385-053 HUMAN OTC DRUG Povidone Iodine povidone-iodine SOLUTION TOPICAL 20050201 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen POVIDONE-IODINE .1 mg/mL 24385-054_d84a0c76-ad50-4616-9252-84ca25a19ca0 24385-054 HUMAN OTC DRUG good neighbor pharmacy nasal decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19990812 ANDA ANDA075153 Amerisource Bergen PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 24385-058_2e29b4cb-ffab-436e-b3af-fc0ee7db8c52 24385-058 HUMAN OTC DRUG Good Neighbor Pharmacy ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060614 ANDA ANDA077349 Amerisource Bergen IBUPROFEN 200 mg/1 24385-059_f6890378-0271-40ec-8556-4dc62dd32dd8 24385-059 HUMAN OTC DRUG Good Neighbor Pharmacy ibuprofen Ibuprofen TABLET, COATED ORAL 20060328 ANDA ANDA077349 Amerisource Bergen IBUPROFEN 200 mg/1 24385-060_27da22e1-d204-4a26-b449-873693070dcf 24385-060 HUMAN OTC DRUG Good Neighbor Pharmacy Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B AmerisourceBergen BACITRACIN ZINC 500 [iU]/g 24385-061_ede880b7-0712-4041-a713-d0c62bc39a86 24385-061 HUMAN OTC DRUG good neighbor pharmacy triple antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20050802 OTC MONOGRAPH FINAL part333 Amerisource Bergen BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 24385-065_06c72836-e1f8-4432-914b-7756e1858aeb 24385-065 HUMAN OTC DRUG Alcohol Pad isopropyl alcohol SWAB TOPICAL 19950801 OTC MONOGRAPH NOT FINAL part333E Amerisource Bergen ISOPROPYL ALCOHOL .7 mL/1 24385-066_34de34ae-1036-4652-bc3d-b922dc5a283e 24385-066 HUMAN OTC DRUG good neighbor pharmacy cold multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 19930330 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 24385-067_378d2bfc-707e-404d-a94f-2b49f5077cff 24385-067 HUMAN OTC DRUG good neighbor pharmacy nasal extra moisturizing Oxymetazoline HCl SPRAY NASAL 19950504 OTC MONOGRAPH FINAL part341 Amerisource Bergen OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 24385-070_7b22d6ee-ff45-42b2-96c0-e86718595506 24385-070 HUMAN OTC DRUG Good Neighbor Pharmacy Vitamin A and D Lanolin, Petrolatum OINTMENT TOPICAL 20050823 OTC MONOGRAPH FINAL part347 Amerisource Bergen LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g 24385-072_d89008cc-2242-436c-bb1c-865febae8091 24385-072 HUMAN OTC DRUG GNP Caldyphen Calamine and Pramoxine Hydrochloride LOTION TOPICAL 20080101 OTC MONOGRAPH FINAL part347 Amerisource Bergen PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 10; 80 mg/mL; mg/mL 24385-076_cd6f6641-99a7-4cd6-bc38-d2f91b02fc4e 24385-076 HUMAN OTC DRUG good neighbor pharmacy cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20081006 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 24385-088_a674294f-c7c1-453d-8151-1615bd298904 24385-088 HUMAN OTC DRUG good neighbor pharmacy sinus congestion and pain Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20080825 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 24385-098_4f845bdf-78e0-41db-829c-45b4e7d429ea 24385-098 HUMAN OTC DRUG Tussin Cough Long Acting DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20100323 OTC MONOGRAPH FINAL part341 Good Neighbor Pharmacy DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL 24385-105_5f283c13-fe33-4830-af04-b48f7e768891 24385-105 HUMAN OTC DRUG good neighbor pharmacy pain relief childrens Acetaminophen SUSPENSION ORAL 19980312 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL 24385-110_ebdb3ced-a710-4cbf-9950-e4980d4acadc 24385-110 HUMAN OTC DRUG Good Neighbor Pharmacy Clotrimazole 3 Clotrimazole CREAM VAGINAL 20000412 NDA NDA021143 AmerisourceBergen CLOTRIMAZOLE 2 g/100g 24385-111_ba74fadd-acd1-432a-956a-0e906512e240 24385-111 HUMAN OTC DRUG Good Neighbor Pharmacy Heartburn Relief Cimetidine TABLET ORAL 20000105 ANDA ANDA075285 Amerisource Bergen CIMETIDINE 200 mg/1 24385-116_8105e191-1118-4d91-b168-fc42aaa9af47 24385-116 HUMAN OTC DRUG good neighbor pharmacy Lice Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070731 OTC MONOGRAPH FINAL part358G Amerisource Bergen PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL 24385-130_fbe8235d-3e79-4dd4-8991-2ffc42445f09 24385-130 HUMAN OTC DRUG good neighbor pharmacy pain relief childrens Acetaminophen SUSPENSION ORAL 19890915 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL 24385-133_11dcfcb3-ae62-4fd7-a1c7-d211e8c6038c 24385-133 HUMAN OTC DRUG Soothing Bath Treatment Colloidal Oatmeal POWDER TOPICAL 19941001 OTC MONOGRAPH FINAL part347 Amerisource Bergen OATMEAL 1 g/g 24385-135_79e5c7de-6967-41fd-84a2-d1897d436e00 24385-135 HUMAN OTC DRUG good neighbor pharmacy cough and sore throat Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20060214 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 24385-141_09ff2eb2-7d4a-468c-8cb1-ffeff0754c97 24385-141 HUMAN OTC DRUG Good Neighbor Pharmacy Muscle Rub Ultra Strength Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20050802 OTC MONOGRAPH NOT FINAL part348 Amerisource Bergen CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g 24385-143_53270d3d-2d3d-4779-9dd5-54766406de05 24385-143 HUMAN OTC DRUG Good Neighbor Pharmacy Triple Antibiotic Plus Pain Relief Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Amerisource Bergen BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g 24385-145_b876ffee-200c-4100-a72f-23d98ee5cc3e 24385-145 HUMAN OTC DRUG good neighbor pharmacy pain relief extra strength Acetaminophen TABLET, FILM COATED ORAL 20060105 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 500 mg/1 24385-146_c7d2fe61-f759-4de0-be63-0222e32ea899 24385-146 HUMAN OTC DRUG good neighbor pharmacy pain relief childrens Acetaminophen SUSPENSION ORAL 19931012 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL 24385-147_f9b73b21-6936-4354-97f2-59f5401b450e 24385-147 HUMAN OTC DRUG good neighbor pharmacy allergy multi symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20061212 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 24385-148_e2d58318-8ae4-4546-9600-aa176f6ca59c 24385-148 HUMAN OTC DRUG Triacting Day Time with PE DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20090720 OTC MONOGRAPH FINAL part341 Good Neighbor Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 24385-152_8e65ebba-e26c-47a3-8e59-055b052fb000 24385-152 HUMAN OTC DRUG Triacting Night Time Cold and Cough DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20090720 OTC MONOGRAPH FINAL part341 Good Neighbor Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 24385-154_e16e295e-60bd-4c66-a88e-0883f3793c2f 24385-154 HUMAN OTC DRUG Flu Relief Therapy Night Time Acetaminophen, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20090831 OTC MONOGRAPH FINAL part341 Good Neighbor Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL 24385-155_6323e4df-89ed-4187-8eff-8099f5c354c3 24385-155 HUMAN OTC DRUG Flu Relief Therapy Day Time Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20090831 OTC MONOGRAPH FINAL part341 Good Neighbor Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 24385-156_3fb90dd7-feee-4c79-ad23-2cf20195c893 24385-156 HUMAN OTC DRUG Cough Relief DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20090701 OTC MONOGRAPH FINAL part341 Good Neighbor Pharmacy DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 24385-157_d43cbc6f-0867-447a-b67a-e1e8ee2b34a8 24385-157 HUMAN OTC DRUG Childrens Mucus Relief Expectorant Grape GUAIFENESIN LIQUID ORAL 20090720 OTC MONOGRAPH FINAL part341 Good Neighbor Pharmacy GUAIFENESIN 100 mg/5mL 24385-158_3cda0512-ac7e-4c9d-a67a-aa45fafaf90b 24385-158 HUMAN OTC DRUG Childrens Mucus Relief DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20090720 OTC MONOGRAPH FINAL part341 Good Neighbor Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 24385-159_116428a6-407f-4fd9-9e7a-f1304bade22c 24385-159 HUMAN OTC DRUG Cough Relief Grape DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20090701 OTC MONOGRAPH FINAL part341 Good Neighbor Pharmacy DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 24385-161_ba155366-479c-4de8-b02f-cc287131a60d 24385-161 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Good Neighbor Pharmacy LORATADINE 10 mg/1 24385-165_ec1ca0fa-5325-41be-a4fb-101cef5abdb5 24385-165 HUMAN OTC DRUG good neighbor pharmacy arthritis pain Trolamine Salicylate CREAM TOPICAL 19900215 OTC MONOGRAPH NOT FINAL part348 Amerisource Bergen TROLAMINE SALICYLATE 10 g/100g 24385-169_fe2205b7-c0fc-4fc8-9dda-497dd7ec10f2 24385-169 HUMAN OTC DRUG good neighbor pharmacy sinus congestion and pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20061227 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 24385-170_31a14b4d-86cc-409c-9eb4-aca6653917f9 24385-170 HUMAN OTC DRUG good neighbor pharmacy nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070130 ANDA ANDA076777 Amerisource Bergen NICOTINE 2 mg/1 24385-171_eaa70a28-26db-4891-8917-4309e932236a 24385-171 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 19910918 ANDA ANDA076779 Amerisource Bergen NICOTINE 4 mg/1 24385-175_c2054637-65b4-4944-9fe8-253965c19b9a 24385-175 HUMAN OTC DRUG Good Neighbor Pharmacy All Day Allergy D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080506 ANDA ANDA077170 Amerisource Bergen CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 24385-183_6cfba0e9-731b-4a34-b4ab-ee91ec6e9e20 24385-183 HUMAN OTC DRUG Good Neighbor Pharmacy Dayhist Allergy Clemastine fumarate TABLET ORAL 19960628 ANDA ANDA074512 Amerisource Bergen CLEMASTINE FUMARATE 1.34 mg/1 24385-188_987558e7-1659-45ec-ae8c-1ce52a60ae33 24385-188 HUMAN OTC DRUG good neighbor pharmacy all day allergy cetirizine hydrochloride LIQUID ORAL 20080422 ANDA ANDA090254 Amerisource Bergen CETIRIZINE HYDROCHLORIDE 5 mg/5mL 24385-190_1bcedd11-81cc-47ed-b23d-416c614b19be 24385-190 HUMAN OTC DRUG Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skin Hydrocortisone CREAM TOPICAL 20010913 OTC MONOGRAPH NOT FINAL part348 AmerisourceBergen HYDROCORTISONE .5 g/100g 24385-193_71b39099-f102-419f-84c1-8e2c6d6d43ae 24385-193 HUMAN OTC DRUG womens laxative Bisacodyl TABLET ORAL 20100715 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 BISACODYL 5 mg/1 24385-195_67c337e2-8bdb-4684-a67f-99b7993a84f0 24385-195 HUMAN OTC DRUG good neighbor pharmacy cold head congestion Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070719 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 24385-197_4fadfe7f-d069-4c1d-9df4-622d09484f47 24385-197 HUMAN OTC DRUG Good Neighbor Pharmacy Cold Head Congestion Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 19920706 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 24385-200_6d97c9b1-3107-4ef2-b738-1d4c6c21c63b 24385-200 HUMAN OTC DRUG Hygienic Cleansing Pads witch hazel SOLUTION RECTAL; TOPICAL 20030501 OTC MONOGRAPH FINAL part346 Amerisource Bergen WITCH HAZEL .5 mL/mL 24385-201_fdf66de5-7d61-4908-ac96-7625c575dbe8 24385-201 HUMAN OTC DRUG good neighbor pharmacy complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080804 ANDA ANDA077355 Amerisource Bergen CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 24385-202_484dfa69-e62e-477c-98fe-0b5a1010c0c5 24385-202 HUMAN OTC DRUG good neighbor pharmacy complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080804 ANDA ANDA077355 Amerisource Bergen CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 24385-203_e22bab9f-0cee-42b5-9fa9-3fca416de041 24385-203 HUMAN OTC DRUG good neighbor pharmacy Night time acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20060523 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 24385-205_00b4c106-346c-48a1-a62e-19230c73d15e 24385-205 HUMAN OTC DRUG Good Neighbor Pharmacy Clotrimazole Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C AmerisourceBergen CLOTRIMAZOLE 10 mg/g 24385-207_fb2dca8c-6526-4558-9ad0-30fdd42988d8 24385-207 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090816 OTC MONOGRAPH FINAL part333 Good Neighbor Pharmacy ISOPROPYL ALCOHOL 70 mL/100mL 24385-210_a077ddc0-abcb-45ef-8652-65429fda89a5 24385-210 HUMAN OTC DRUG Anti-Itch Diphenhydramine hydrochloride and Zinc acetate CREAM TOPICAL 20050920 OTC MONOGRAPH NOT FINAL part348 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g 24385-213_f4841606-d060-43f6-9708-4dca09847024 24385-213 HUMAN OTC DRUG GNP Idoinde Tincture 2% Mild Iodine and Sodium Iodide and Alcohol LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen ALCOHOL; IODINE; SODIUM IODIDE 470; 20; 20.4 mg/mL; mg/mL; mg/mL 24385-214_f5f50050-20ba-45dd-81c4-21b6386f46fc 24385-214 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090826 OTC MONOGRAPH NOT FINAL part356 Good Neighbor Pharmacy HYDROGEN PEROXIDE 2.65 mL/100mL 24385-255_5f550423-6d76-44c0-8531-657b5d7fe344 24385-255 HUMAN OTC DRUG Good Neighbor Pharmacy Acid Reducer Famotidine TABLET, COATED ORAL 20010605 ANDA ANDA075312 Amerisource Bergen FAMOTIDINE 10 mg/1 24385-268_5075da08-56b5-400a-8219-31b8355652f6 24385-268 HUMAN OTC DRUG Good Neighbor Pharmacy Acid Control 150 Maximum Strength Ranitidine TABLET ORAL 20080219 ANDA ANDA078653 Amerisource Bergen RANITIDINE HYDROCHLORIDE 150 mg/1 24385-274_0e83d65a-46b5-44ae-8558-3392fe97a2c5 24385-274 HUMAN OTC DRUG Good Neighbor Pharmacy Hydrocortisone with Aloe Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 AmerisourceBergen HYDROCORTISONE 1 g/100g 24385-276_2e83c8a7-5e89-40d4-86d7-ca9ad23d7516 24385-276 HUMAN OTC DRUG Good Neighbor Pharmacy Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 AmerisourceBergen HYDROCORTISONE 1 g/100g 24385-278_a0828f44-e86a-4dc3-a7f4-e8d2e5a50d83 24385-278 HUMAN OTC DRUG good neighbor pharmacy aspirin Aspirin TABLET, CHEWABLE ORAL 19970626 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ASPIRIN 81 mg/1 24385-283_267b9c67-dec9-422c-a3e9-1d271fc0881b 24385-283 HUMAN OTC DRUG good neighbor pharmacy anti itch HYDROCORTISONE LOTION TOPICAL 20050909 OTC MONOGRAPH NOT FINAL part348 Amerisource Bergen HYDROCORTISONE 1 g/mL 24385-289_1defa32d-33df-468e-b4a3-62050165a4f5 24385-289 HUMAN OTC DRUG good neighbor pharmacy pain relief infants Acetaminophen SUSPENSION/ DROPS ORAL 19931102 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 80 mg/.8mL 24385-291_d6a19599-babf-4fe5-8857-157212949242 24385-291 HUMAN OTC DRUG good neighbor pharmacy anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 19940401 UNAPPROVED DRUG OTHER Amerisource Bergen DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 24385-296_71f078a3-fef8-40c2-b5c1-171f2729dec8 24385-296 HUMAN OTC DRUG Good Neighbor Pharmacy Acid Control Ranitidine TABLET ORAL 20090516 ANDA ANDA076760 Amerisource Bergen RANITIDINE HYDROCHLORIDE 75 mg/1 24385-301_bca43b81-11cc-4c95-a802-379f9d965971 24385-301 HUMAN OTC DRUG Magnesium Citrate Magnesium Citrate LIQUID ORAL 20090729 OTC MONOGRAPH NOT FINAL part334 Good Neighbor Pharmacy MAGNESIUM CITRATE 2.65 mL/100mL 24385-304_7381b2e8-ea94-4b50-94e6-8991ba4cfd04 24385-304 HUMAN OTC DRUG Magnesium Citrate Magnesium Citrate LIQUID ORAL 20090729 OTC MONOGRAPH NOT FINAL part334 Good Neighbor Pharmacy MAGNESIUM CITRATE 2.65 mL/100mL 24385-305_c4517feb-1f6e-4b50-ae16-93bfd95ccec7 24385-305 HUMAN OTC DRUG Good Neighbor Pharmacy Night Time D Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID ORAL 19940828 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 500; 15; 6.25; 30 mg/15mL; mg/15mL; mg/15mL; mg/15mL 24385-307_30bcb7a8-57be-4235-83cd-3b5da2586863 24385-307 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090813 OTC MONOGRAPH FINAL part333 Good Neighbor Pharmacy ISOPROPYL ALCOHOL 70 mL/100mL 24385-310_01ae0d7d-c31d-4a47-b582-03b52a377cb7 24385-310 HUMAN OTC DRUG good neighbor pharmacy tussin Guaifenesin SYRUP ORAL 19890815 OTC MONOGRAPH FINAL part341 Amerisource Bergen GUAIFENESIN 100 mg/5mL 24385-313_d35e9725-0348-4d7e-aa7f-0d172ea04526 24385-313 HUMAN OTC DRUG good neighbor pharmacy pain relief infants Acetaminophen SUSPENSION/ DROPS ORAL 19890915 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 80 mg/.8mL 24385-316_2f8b5a55-e5fc-47b4-8423-a9125558c0ed 24385-316 HUMAN OTC DRUG Good Neighbor Pharmacy Night Time acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20060523 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 24385-322_8dbecba9-fa18-47a7-ad0e-afa2295e4072 24385-322 HUMAN OTC DRUG Good Neighbor Pharmacy Night Time D Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Pseudoephedrine HCl LIQUID ORAL 19920929 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 500; 15; 6.25; 30 mg/15mL; mg/15mL; mg/15mL; mg/15mL 24385-328_51bd7746-7d1c-407f-99c4-a4c9b4739e38 24385-328 HUMAN OTC DRUG Good Neighbor Pharmacy Sore Throat Phenol SPRAY ORAL 19940103 OTC MONOGRAPH NOT FINAL part356 Amerisource Bergen PHENOL 1.4 mL/100mL 24385-332_ade4c74f-ef00-435b-82a1-78066d6a2706 24385-332 HUMAN OTC DRUG good neighbor pharmacy milk of magnesia Magnesium hydroxide SUSPENSION ORAL 19900415 OTC MONOGRAPH NOT FINAL part334 Amerisource Bergen MAGNESIUM HYDROXIDE 1200 mg/15mL 24385-337_674c788b-e37f-4717-9e2f-e0a0d24548b9 24385-337 HUMAN OTC DRUG Peptic Relief Maximum Strength Maximum Strength Pepto Bismol SUSPENSION ORAL 20120101 OTC MONOGRAPH FINAL part335 Good Neighbor Pharmacy BISMUTH SUBSALICYLATE 525 mg/15mL 24385-340_933dd446-73f6-47c6-be99-9130999393c2 24385-340 HUMAN OTC DRUG Good Neighbor Pharmacy Antacid aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 19900915 OTC MONOGRAPH FINAL part331 Amerisource Bergen ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 24385-351_ab5a4d78-2aca-49e4-92e9-4efdcf6c8d93 24385-351 HUMAN OTC DRUG allergy and congestion relief non drowsy Pseudoephedrine sulfate, Loratadine TABLET, FILM COATED ORAL 20101113 ANDA ANDA075989 Amerisource Bergen LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 24385-352_ba4ae0d6-e8c1-48e3-8808-0c72cdf8e1f2 24385-352 HUMAN OTC DRUG Good Neighbor Pharmacy Nasal Oxymetazoline HCl SPRAY NASAL 20020306 OTC MONOGRAPH FINAL part341 Amerisource Bergen OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 24385-356_1e9b7b3a-f41b-4223-83e9-88c0478aea67 24385-356 HUMAN OTC DRUG Good Neighbor Pharmacy Antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20021105 OTC MONOGRAPH FINAL part332 Amerisource Bergen ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 24385-357_d37ef20d-96a4-4847-97c1-ed759740f3d9 24385-357 HUMAN OTC DRUG Good Neighbor Pharmacy Antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19900615 OTC MONOGRAPH FINAL part332 Amerisource Bergen ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 24385-359_98f08e40-896b-4bdf-b21c-6080c574d8d1 24385-359 HUMAN OTC DRUG Good Neighbor Pharmacy Tussin dm Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 19910827 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 24385-361_b9124d04-b5d5-432b-b9d4-694ef43ecccc 24385-361 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20020513 ANDA ANDA074937 Amerisource Bergen IBUPROFEN 100 mg/5mL 24385-362_3ae98cd1-9c85-4396-ae67-b6a45a6924ea 24385-362 HUMAN OTC DRUG Good Neighbor Pharmacy Antacid Aluminum Hydroxide, Magnesium Hydroxide, Simethicone LIQUID ORAL 20060823 OTC MONOGRAPH FINAL part332 Amerisource Bergen ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 24385-364_92594258-bf2a-4756-831e-7552104565a2 24385-364 HUMAN OTC DRUG Good Neighbor Pharmacy aspirin orange flavor chewable Aspirin TABLET, CHEWABLE ORAL 20020220 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ASPIRIN 81 mg/1 24385-365_f58e0d48-c54b-48dc-9986-921b34567653 24385-365 HUMAN OTC DRUG good neighbor pharmacy migraine relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20020513 ANDA ANDA075794 Amerisource Bergen ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 24385-368_2ed306ab-522a-450f-99e8-0e78c3199875 24385-368 HUMAN OTC DRUG good neighbor pharmacy pain relief all day Naproxen Sodium TABLET, FILM COATED ORAL 19970115 ANDA ANDA074661 Amerisource Bergen NAPROXEN SODIUM 220 mg/1 24385-369_fe74f894-5335-4e15-8e15-a4614dc99829 24385-369 HUMAN OTC DRUG Laxative pills maximum strength Sennosides TABLET ORAL 20100708 OTC MONOGRAPH NOT FINAL part334 Amerisourcebergen Drug Corporation (Good Neighbour Pharmacy) SENNOSIDES 25 mg/1 24385-370_6cf7db6c-3cd7-4d25-9020-8116152cc20c 24385-370 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20141027 OTC MONOGRAPH NOT FINAL part333A Amerisource Begen ALCOHOL 70 mL/100mL 24385-372_8164c048-4839-44c9-b12e-91933729c00d 24385-372 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20020402 ANDA ANDA074937 Amerisource Bergen IBUPROFEN 100 mg/5mL 24385-374_66ff4738-f36c-4b19-ac1f-a152a42990d7 24385-374 HUMAN OTC DRUG Good Neighbor Pharmacy Tioconazole 1 Tioconazole OINTMENT VAGINAL 20080220 ANDA ANDA075915 Amerisource Bergen TIOCONAZOLE 6.5 g/100g 24385-377_e6f5d456-c674-4b93-80b4-2a57e23bf8ed 24385-377 HUMAN OTC DRUG Good Neighbor Pharmacy Anti Diarrheal Loperamide HCl SOLUTION ORAL 20030919 ANDA ANDA073243 Amerisource Bergen LOPERAMIDE HYDROCHLORIDE 1 mg/5mL 24385-379_55368104-06cb-4e80-b432-2e48bd23070b 24385-379 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Allergy Liquid Diphenhydramine Hydrochloride LIQUID ORAL 19890815 OTC MONOGRAPH FINAL part341 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 24385-385_0b0113b5-0dff-4ebf-9433-2ba762a7087b 24385-385 HUMAN OTC DRUG Good Neighbor Pharmacy Acid Reducer Maximum Strength Famotidine TABLET ORAL 20061024 ANDA ANDA077351 Amerisource Bergen FAMOTIDINE 20 mg/1 24385-386_8753a5ef-f87b-438a-a3a4-53827e946476 24385-386 HUMAN OTC DRUG good neighbor pharmacy anti diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20080626 ANDA ANDA075232 Amerisource Bergen LOPERAMIDE HYDROCHLORIDE 2 mg/1 24385-388_c164385f-37ed-40fd-8a22-8242c8daf399 24385-388 HUMAN OTC DRUG Motion sickness Relief Meclizine Hydrochloride TABLET ORAL 20100709 OTC MONOGRAPH FINAL part336 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 MECLIZINE HYDROCHLORIDE 25 mg/1 24385-390_32d3e008-c276-4076-840e-26db908e6384 24385-390 HUMAN OTC DRUG good neighbor pharmacy nose Phenylephrine hydrochloride LIQUID NASAL 19940401 OTC MONOGRAPH FINAL part341 Amerisource Bergen PHENYLEPHRINE HYDROCHLORIDE 1 mL/100mL 24385-396_00ea2aef-2723-49dc-b763-2617f96882b8 24385-396 HUMAN OTC DRUG Good Neighbor Pharmacy milk of magnesia Magnesium hydroxide SUSPENSION ORAL 19900215 OTC MONOGRAPH NOT FINAL part334 Amerisource Bergen MAGNESIUM HYDROXIDE 1200 mg/15mL 24385-403_210b656e-88e7-4944-8fe8-0a67c5293553 24385-403 HUMAN OTC DRUG good neighbor pharmacy pain relief regular strength Acetaminophen TABLET ORAL 19900215 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 325 mg/1 24385-404_9089757d-2174-4deb-8d40-cd36418ac9b9 24385-404 HUMAN OTC DRUG Good Neighbor Senna Sennosides TABLET ORAL 20121102 OTC MONOGRAPH FINAL part334 AmerisourceBergen SENNOSIDES A AND B 8.6 mg/1 24385-405_0584d195-ae50-479d-9440-9fd6a07151e6 24385-405 HUMAN OTC DRUG Good Neighbor Pharmacy Pain Relief Acetaminophen TABLET ORAL 19900515 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 500 mg/1 24385-407_cb7abed3-d364-42c8-a69c-000cdf62d35a 24385-407 HUMAN OTC DRUG Calamine Phenolated Topical Suspension Calamine and Zinc Oxide and Phenol LOTION TOPICAL 20080101 OTC MONOGRAPH FINAL part347 Amerisource Bergen PHENOL; ZINC OXIDE 10; 160 mg/mL; mg/mL 24385-413_ad05547f-dd58-4d38-b6db-cf26dd96de6c 24385-413 HUMAN OTC DRUG GNP Calamine Topical Suspension Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 20080101 OTC MONOGRAPH FINAL part347 Amerisource Bergen ZINC OXIDE 160 mg/mL 24385-416_91412263-9c8f-4705-9398-fd503026df21 24385-416 HUMAN OTC DRUG Good Neighbor Pharmacy Aspirin Aspirin TABLET ORAL 19890915 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ASPIRIN 325 mg/1 24385-421_ba83b1fe-23a3-4673-8b31-e47d02cf1cd7 24385-421 HUMAN OTC DRUG Hemorrhoidal Cooling Gel phenylephrine and witch hazel GEL TOPICAL 20060801 OTC MONOGRAPH FINAL part346 Amerisource Bergen PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/g; g/g 24385-428_4183595f-bbb8-41e9-ba75-807055c47848 24385-428 HUMAN OTC DRUG Good Neighbor Pharmacy Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 19990812 OTC MONOGRAPH FINAL part332 Amerisource Bergen DIMETHICONE 125 mg/1 24385-429_1957f9d8-2d1f-492c-8f6a-db312aba722b 24385-429 HUMAN OTC DRUG Aspirin regular strength Aspirin TABLET, COATED ORAL 20111117 OTC MONOGRAPH FINAL part343 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 ASPIRIN 325 mg/1 24385-430_a56ea03d-21f7-481c-87e3-a21f023f0d2b 24385-430 HUMAN OTC DRUG good neighbor pharmacy headache relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19920616 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 24385-431_5b806dae-64f9-4f3a-b4cf-ac89f0d16a72 24385-431 HUMAN OTC DRUG Good Neighbor Pharmacy Sleep Aid Diphenhydramine Hydrochloride TABLET ORAL 20010414 OTC MONOGRAPH FINAL part338 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 24385-432_3f78baf7-3582-48c7-9ecc-86115ac32e84 24385-432 HUMAN OTC DRUG Good Neighbor Pharmacy Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 19890815 OTC MONOGRAPH FINAL part341 Amerisource Bergen PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 24385-435_04f3a417-a543-4043-aaf1-e87f85fd1b7c 24385-435 HUMAN OTC DRUG Docusate Calcium stool softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20100712 OTC MONOGRAPH NOT FINAL part334 Amerisourcebergen Drug Corporation (Good Neighbour Pharmacy) DOCUSATE CALCIUM 240 mg/1 24385-436_2f3bbfce-d4ae-4fe2-a400-ad969bdb0baf 24385-436 HUMAN OTC DRUG stool softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100708 OTC MONOGRAPH NOT FINAL part334 Amerisourcebergen Drug Corporation (Good Neighbour Pharmacy) DOCUSATE SODIUM 100 mg/1 24385-437_f2ffeead-9b8c-4230-b7df-bc94f0ea8ca6 24385-437 HUMAN OTC DRUG Good Neighbor Pharmacy Pain Relief PM Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19931227 OTC MONOGRAPH FINAL part338 Amerisource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 24385-439_2fbbb4fa-1f07-4adb-b2ba-50a15dd2dec9 24385-439 HUMAN OTC DRUG Caldyphen Clear Pramoxine Hydrochloride and Zinc acetate LOTION TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part348 Amerisource Bergen PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL 24385-441_0c4f7232-4889-4cca-a807-c6d6aaa183e6 24385-441 HUMAN OTC DRUG Good Neighbor Pharmacy Sleep Aid Doxylamine succinate TABLET ORAL 19970626 ANDA ANDA040167 Amerisource Bergen DOXYLAMINE SUCCINATE 25 mg/1 24385-443_19bf22b6-aa77-4b98-9894-ba0e0cf3ef40 24385-443 HUMAN OTC DRUG STOOL SOFTENER EXTRA STRENGTH DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Amerisourcebergen Drug Corporation (Good Neighbour Pharmacy) DOCUSATE SODIUM 250 mg/1 24385-460_e445123e-23c7-46f5-bb5f-ee9537917d91 24385-460 HUMAN OTC DRUG AntiGas ultra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20100708 OTC MONOGRAPH FINAL part332 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 DIMETHICONE 180 mg/1 24385-461_3cfaee9f-cbb6-45c3-8674-121622195cdd 24385-461 HUMAN OTC DRUG Good Neighbor Pharmacy night time cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20030630 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 6.25 mg/15mL; mg/15mL 24385-462_222c5ddd-cc5a-48e1-854f-d8129aa24ad1 24385-462 HUMAN OTC DRUG good neighbor pharmacy allergy diphenhydramine hydrochloride CAPSULE ORAL 19891015 OTC MONOGRAPH FINAL part341 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 24385-463_01a87ff3-154b-4116-af37-1e48251cba9f 24385-463 HUMAN OTC DRUG Good Neighbor Pharmacy Allergy Chlorpheniramine Maleate TABLET ORAL 19890715 OTC MONOGRAPH FINAL part341 Amerisource Bergen CHLORPHENIRAMINE MALEATE 4 mg/1 24385-465_319c72cd-dd49-4193-9118-b9c164cd0a9a 24385-465 HUMAN OTC DRUG Good Neighbor Pharmacy Ibuprofen Cold and Sinus Ibuprofen, Pseudoephedrine Hydrochloride TABLET ORAL 20011015 ANDA ANDA074567 Amerisource Bergen IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 24385-471_cd474233-faa0-460a-bdbb-f506e0998cc7 24385-471 HUMAN OTC DRUG good neighbor pharmacy loratadine Loratadine TABLET ORAL 20081110 ANDA ANDA076301 Amerisource Bergen LORATADINE 10 mg/1 24385-479_9f268bff-e591-42f6-bdda-2309b42ab1b7 24385-479 HUMAN OTC DRUG Good Neighbor Pharmacy allergy Diphenhydramine Hydrochloride TABLET ORAL 19910830 OTC MONOGRAPH FINAL part341 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 24385-484_eca3875d-bae6-41dd-b520-a86fae96f062 24385-484 HUMAN OTC DRUG Good Neighbor Pharmacy Pain Relief Acetaminophen TABLET ORAL 19891215 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 500 mg/1 24385-490_61f06b0e-358c-409d-81cf-9cb65a8f579f 24385-490 HUMAN OTC DRUG Good Neighbor Pharmacy naproxen sodium Naproxen Sodium TABLET ORAL 19980312 ANDA ANDA074661 Amerisource Bergen NAPROXEN SODIUM 220 mg/1 24385-493_2f97b007-e5ff-479e-bb80-7b47b5aa52f9 24385-493 HUMAN OTC DRUG Good Neighbor Pharmacy Tussin Dextromethorphan Hydrobromide LIQUID ORAL 19920210 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL 24385-494_5544cd84-64f5-488d-acb5-c6f3666051db 24385-494 HUMAN OTC DRUG good neighbor pharmacy eye itch relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20101113 ANDA ANDA077958 Amerisource Bergen KETOTIFEN FUMARATE .25 mg/mL 24385-495_10783ab4-7091-4ade-94b4-324f717ec6a7 24385-495 HUMAN OTC DRUG Stool Softener and Stimulant Laxative Docusate sodium and Sennosides TABLET ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Amerisourcebergen Drug Corporation (Good Neighbour Pharmacy) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 24385-498_f5107d5a-bd5c-4ae5-b374-5babd769eb1c 24385-498 HUMAN OTC DRUG Good Neighbor Pharmacy Nasal Oxymetazoline HCl SPRAY NASAL 19950316 OTC MONOGRAPH FINAL part341 Amerisource Bergen OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 24385-499_51091b93-a39c-4098-a386-ae58dd413526 24385-499 HUMAN OTC DRUG Ibuprofen softgels Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100708 ANDA ANDA078682 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) IBUPROFEN 200 mg/1 24385-505_447879b9-e0fe-4f63-9765-c8e03b5c13da 24385-505 HUMAN OTC DRUG Senna Plus docusate sodium and sennosides TABLET ORAL 20100715 OTC MONOGRAPH NOT FINAL part334 Amerisourcebergen Drug Corporation (Good Neighbour Pharmacy) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 24385-517_730cbc91-f2d9-41b6-8e56-d7e1e931e17d 24385-517 HUMAN OTC DRUG good neighbor pharmacy cold and allergy childrens phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20060919 OTC MONOGRAPH FINAL part341 Amerisource Bergen BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 24385-518_2f0ef205-49bb-4a74-b000-2f9823ec6179 24385-518 HUMAN OTC DRUG Good Neighbor Pharmacy Allergy Relief Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20040315 ANDA ANDA075990 Amerisource Bergen LORATADINE 10 mg/1 24385-519_da91e6b6-32ff-44fd-afce-33ea9549554b 24385-519 HUMAN OTC DRUG good neighbor pharmacy cold and cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20060911 OTC MONOGRAPH FINAL part341 Amerisource Bergen BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 24385-524_60c3c3ef-8f8c-4650-9c71-c4bb8e7d74be 24385-524 HUMAN OTC DRUG Good Neighbor Pharmacy Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 AmerisourceBergen TERBINAFINE HYDROCHLORIDE 1 g/100g 24385-531_c173efeb-b7ef-4846-b161-7aad21f3a984 24385-531 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 AmerisourceBergen LORATADINE 5 mg/5mL 24385-532_8c834486-0f6f-44f4-a15b-06d0e3d417cc 24385-532 HUMAN OTC DRUG Good Neighbor Pharmacy Sore Throat Phenol SPRAY ORAL 19930409 OTC MONOGRAPH NOT FINAL part356 Amerisource Bergen PHENOL 1.4 mL/100mL 24385-535_e3f7bc4a-73df-4203-9099-c6805c57f7ea 24385-535 HUMAN OTC DRUG Good Neighbor Pharmacy Aspirin Enteric Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 19940329 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ASPIRIN 81 mg/1 24385-540_ba155366-479c-4de8-b02f-cc287131a60d 24385-540 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Good Neighbor Pharmacy LORATADINE 10 mg/1 24385-541_c88c0cf5-71fb-45fd-adca-1f7746665e78 24385-541 HUMAN OTC DRUG good neighbor pharmacy aspirin Aspirin TABLET, FILM COATED ORAL 20041019 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ASPIRIN 81 mg/1 24385-542_f2163736-58e5-4556-857c-c037bd5f8267 24385-542 HUMAN OTC DRUG good neighbor pharmacy cold severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 19910615 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 24385-543_f87a080d-e3aa-4698-8c65-915d8ea77da2 24385-543 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 AmerisourceBergen LORATADINE 5 mg/5mL 24385-544_fe36dc63-673d-4466-b2d6-bada809bdf1c 24385-544 HUMAN OTC DRUG Good Neighbor Pharmacy headache relief Acetaminophen, Caffeine TABLET, FILM COATED ORAL 20090223 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 24385-546_c02a347d-df05-4191-b506-1b2ad754a014 24385-546 HUMAN OTC DRUG good neighbor pharmacy ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20041012 ANDA ANDA076359 Amerisource Bergen IBUPROFEN 100 mg/1 24385-549_224ea181-4beb-4102-a263-31c9a4c84cdf 24385-549 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Ibuprofen Cold Ibuprofen, Pseudoephedrine HCl SUSPENSION ORAL 19890415 ANDA ANDA076478 Amerisource Bergen IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100; 15 mg/5mL; mg/5mL 24385-550_19d3af1c-9dd5-48d9-bd5c-05cc8745e836 24385-550 HUMAN OTC DRUG good neighbor pharmacy ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20041012 ANDA ANDA075217 Amerisource Bergen IBUPROFEN 50 mg/1.25mL 24385-554_48078785-0384-4ca5-bd95-a8b3602084ae 24385-554 HUMAN OTC DRUG good neighbor pharmacy anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030512 ANDA ANDA075232 Amerisource Bergen LOPERAMIDE HYDROCHLORIDE 2 mg/1 24385-578_6e9bcec0-f09f-4004-b53d-93f5a4bafe7e 24385-578 HUMAN OTC DRUG good neighbor pharmacy tussin dm Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19940919 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 24385-590_5a3441e8-f4fc-404f-8e9e-6d2aee2b8cec 24385-590 HUMAN OTC DRUG Good Neighbor Pharmacy Miconazole 7 Miconazole nitrate CREAM VAGINAL 19991011 ANDA ANDA074760 Amerisource Bergen MICONAZOLE NITRATE 2 g/100g 24385-594_7e98cdd9-b17c-4d58-a3e5-189c2ed893d2 24385-594 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050831 ANDA ANDA078325 Amerisource Bergen NICOTINE 2 mg/1 24385-597_d0dfa008-d983-4df6-b4a9-25cc48e0610f 24385-597 HUMAN OTC DRUG good neighbor pharmacy nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050831 ANDA ANDA076775 Amerisource Bergen NICOTINE 2 mg/1 24385-598_9c687395-71d6-452a-a4fa-2bb5cf61b7e1 24385-598 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050831 ANDA ANDA078326 Amerisource Bergen NICOTINE 4 mg/1 24385-599_02afc81c-54fa-4595-822c-e180ac69fae8 24385-599 HUMAN OTC DRUG good neighbor pharmacy nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050831 ANDA ANDA076789 Amerisource Bergen NICOTINE 4 mg/1 24385-601_6dfa8621-2e13-4f4d-a0f7-6c7c8fbb2bf5 24385-601 HUMAN OTC DRUG Good Neighbor Pharmacy Stay Awake Caffeine TABLET ORAL 20010716 OTC MONOGRAPH FINAL part340 Amerisource Bergen CAFFEINE 200 mg/1 24385-602_85ae77c0-f496-4839-8bf7-eb0e0e200979 24385-602 HUMAN OTC DRUG Good Neighbor Pharmacy Mucus Relief Guaifenesin TABLET ORAL 20110915 OTC MONOGRAPH FINAL part341 AmerisourceBergen Drug Corp GUAIFENESIN 400 mg/1 24385-603_4f9ec868-c0d8-4b1a-9760-81cf44317cfc 24385-603 HUMAN OTC DRUG good neighbor pharmacy nasal decongestant pe non drowsy Phenylephrine Hydrochloride TABLET ORAL 20050628 OTC MONOGRAPH FINAL part341 Amerisource Bergen PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 24385-604_36427096-37ca-4dee-a972-746e350ea13e 24385-604 HUMAN OTC DRUG good neighbor pharmacy ibuprofen Ibuprofen TABLET ORAL 19900115 ANDA ANDA072096 Amerisource Bergen IBUPROFEN 200 mg/1 24385-606_5b87b837-3f52-40ca-b2b6-9c1f1262d90d 24385-606 HUMAN OTC DRUG Good Neighbor Pharmacy Miconazole Nitrate Miconazole nitrate KIT 20000502 ANDA ANDA075329 Amerisource Bergen 24385-608_a479d194-c11a-4cf5-a1bb-ca63304af93d 24385-608 HUMAN OTC DRUG good neighbor pharmacy milk of magnesia Magnesium hydroxide LIQUID ORAL 20050412 OTC MONOGRAPH NOT FINAL part334 Amerisource Bergen MAGNESIUM HYDROXIDE 1200 mg/15mL 24385-618_ebee4335-7cbb-45bd-828c-e19b12f7c272 24385-618 HUMAN OTC DRUG Good Neighbor Pharmacy Pain Relief Acetaminophen TABLET, COATED ORAL 20050615 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 500 mg/1 24385-619_701b11fe-be96-4ffd-94dc-f986f2404621 24385-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20100712 OTC MONOGRAPH FINAL part347 Amerisource Bergen DIMETHICONE 13.13 mg/mL 24385-623_90d6542f-ef5f-4d90-a6f1-26e371600bb7 24385-623 HUMAN OTC DRUG good neighbor pharmacy Ibuprofen Ibuprofen SUSPENSION ORAL 19991122 ANDA ANDA074937 Amerisource Bergen IBUPROFEN 100 mg/5mL 24385-629_926ea85a-d601-40fc-9c04-ef65f741f082 24385-629 HUMAN OTC DRUG good neighbor pharmacy pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081103 ANDA ANDA075077 Amerisource Bergen ACETAMINOPHEN 650 mg/1 24385-634_8e1085cc-f9d9-4961-b2b1-ef9619ec227a 24385-634 HUMAN OTC DRUG good neighbor pharmacy lice piperonyl butoxide, pyrethrum extract KIT 19940401 OTC MONOGRAPH FINAL part358G Amerisource Bergen 24385-647_d1942bb6-9102-4406-a349-953c44d72b27 24385-647 HUMAN OTC DRUG good neighbor pharmacy ibuprofen Ibuprofen TABLET, COATED ORAL 19890915 ANDA ANDA072096 Amerisource Bergen IBUPROFEN 200 mg/1 24385-676_2fcbd99a-70b9-4e41-b469-defc2aaa0e47 24385-676 HUMAN OTC DRUG Good Neighbor Anti-Fungal Undecylenic acid LIQUID TOPICAL 20080801 OTC MONOGRAPH FINAL part333C AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) UNDECYLENIC ACID 250 mg/mL 24385-677_fc3314e9-515c-4c72-8781-ffa1c1246ace 24385-677 HUMAN OTC DRUG Good Neighbor Pharmacy Arthritis Pain Relief Capsaicin CREAM TOPICAL 20081103 OTC MONOGRAPH NOT FINAL part348 Amerisource Bergen CAPSAICIN .1 g/100g 24385-685_45701055-1ccb-490e-899c-c98558f3628b 24385-685 HUMAN OTC DRUG Minral Oil Mineral Oil OIL ORAL; TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part334 Good Neighbor Pharmacy MINERAL OIL 15 mg/15mL 24385-803_11d662f9-9fe2-4ddf-9387-81c180345ceb 24385-803 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY FIRST AID Contains 202 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN, BENZOCAINE, ALCOHOL KIT 20100502 OTC MONOGRAPH FINAL part333 AmerisourceBergen 24385-804_31fe4b5d-bdbe-4366-b4b6-85fb0b4dba30 24385-804 HUMAN OTC DRUG Good Neighbor Pharmacy Emergency Preparedness and First Aid Contains 167 Pieces BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ASPIRIN, ETHYL ALCOHOL KIT 20100524 OTC MONOGRAPH FINAL part354 AmerisourceBergen 24385-807_7a94f77c-6f5c-43f6-94b7-f0786dfce0d4 24385-807 HUMAN OTC DRUG Epsom Salt Epsom Salt GRANULE, FOR SOLUTION ORAL; TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part334 Good Neighbor Pharmacy MAGNESIUM SULFATE 100 g/100g 24385-807_898c4f09-3046-4b01-8699-f550b4baaecc 24385-807 HUMAN OTC DRUG Epsom Salt Epsom Salt GRANULE, FOR SOLUTION ORAL; TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part334 Good Neighbor Pharmacy MAGNESIUM SULFATE 100 g/100g 24385-903_45fcb168-ab4d-408f-a6f0-b4596be62fd3 24385-903 HUMAN OTC DRUG Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20111024 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 BISACODYL 5 mg/1 24385-904_2aac4a65-7c19-4bea-b077-5d4d7a3c4bc4 24385-904 HUMAN OTC DRUG Good Neighbor Pharmacy Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20060327 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 24385-905_978661f1-6844-4b9c-ade5-edd685982a2c 24385-905 HUMAN OTC DRUG good neighbor pharmacy ibuprofen Ibuprofen SUSPENSION ORAL 19990128 ANDA ANDA074937 Amerisource Bergen IBUPROFEN 100 mg/5mL 24385-910_4d1b2ec4-3bd2-4c85-b0ab-0e4857871fa7 24385-910 HUMAN OTC DRUG Magnesium Citrate Oral Solution Cherry Flavor Magnesium Citrate LIQUID ORAL 20120101 OTC MONOGRAPH NOT FINAL part334 Good Neighbor Pharmacy MAGNESIUM CITRATE 2.65 g/100mL 24385-924_2ae049d2-f7b1-494b-8b56-ea35f9c33a60 24385-924 HUMAN OTC DRUG good neighbor pharmacy cold and allergy pe Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20061121 OTC MONOGRAPH FINAL part341 Amerisource Bergen CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 24385-925_19f17707-05ae-42cf-9b2b-f758ff44a62b 24385-925 HUMAN OTC DRUG Good Neighbor Pharmacy Mucus Relief PE PE Guaifenesin/phenylephrine TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 AmerisourceBergen Drug Corp GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 24385-937_e6cd7017-34bb-47a1-b6d3-ccde3daaa4fb 24385-937 HUMAN OTC DRUG Good Neighbor Pharmacy Ibuprofen PM diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090223 ANDA ANDA079113 Amerisource Bergen DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 24385-955_e9d8b71c-e35f-44fa-9542-d4d2278c9a7f 24385-955 HUMAN OTC DRUG Ear Drops Earwax Removal Aid Carbamide Peroxide LIQUID TOPICAL 20120101 OTC MONOGRAPH FINAL part344 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) CARBAMIDE PEROXIDE 65 mg/mL 24385-958_5996132f-13c9-49a3-ab9e-751db97484ba 24385-958 HUMAN OTC DRUG good neighbor pharmacy cold remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20080805 UNAPPROVED HOMEOPATHIC Amerisource Bergen ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 24385-959_28298cb1-d443-4429-9237-8914bdb89748 24385-959 HUMAN OTC DRUG good neighbor pharmacy sinus Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20080902 OTC MONOGRAPH FINAL part341 Amerisource Bergen 24385-961_1fa9b5cf-6534-460a-897e-1716a273e133 24385-961 HUMAN OTC DRUG Good Neighbor Pharmacy Sinus and Allergy PE Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20061120 OTC MONOGRAPH FINAL part341 Amerisource Bergen CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 24385-962_85651bca-ba47-45af-a6eb-94f6c64222b1 24385-962 HUMAN OTC DRUG good neighbor pharmacy cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20081006 OTC MONOGRAPH FINAL part341 Amerisource Bergen 24385-963_6cc4f501-385c-4f3d-bf19-b8af854ca8e7 24385-963 HUMAN OTC DRUG good neighbor pharmacy cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20081006 OTC MONOGRAPH FINAL part341 Amerisource Bergen 24385-975_cbac6443-b5f1-4ed1-8415-cdd8c785ddee 24385-975 HUMAN OTC DRUG good neighbor pharmacy nicotine Nicotine Polacrilex LOZENGE ORAL 20071010 ANDA ANDA077007 Amerisource Bergen NICOTINE 2 mg/1 24385-976_44978961-0d6f-423b-8e21-1e79745ef299 24385-976 HUMAN OTC DRUG good neighbor pharmacy nicotine Nicotine Polacrilex LOZENGE ORAL 20070905 ANDA ANDA077007 Amerisource Bergen NICOTINE 4 mg/1 24385-980_1652f850-ffd6-46b9-8b37-4d5c0bbbfc81 24385-980 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen BENZALKONIUM CHLORIDE .13 mL/mL 24385-982_ae267fb9-5f23-4f9e-8138-b17d1e37d606 24385-982 HUMAN OTC DRUG Pain Relief Alcohol Swabs benzocaine SWAB TOPICAL 20070501 OTC MONOGRAPH NOT FINAL part348 Amerisource Bergen BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 24385-984_636ecb5b-0391-41cf-b314-0e4a9fd9458e 24385-984 HUMAN OTC DRUG good neighbor pharmacy cold plus multi symptom Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20080902 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 24385-986_9a849064-dbd2-40dc-b2a9-e59c06187c0b 24385-986 HUMAN OTC DRUG good neighbor pharmacy childrens pain relief plus cough and sore throat Acetaminophen, Dextromethorphan HBr SUSPENSION ORAL 20080805 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 5 mg/5mL; mg/5mL 24385-987_94404408-7e8d-4907-9310-07c7359d6cfb 24385-987 HUMAN OTC DRUG Good Neighbor Pharmacy Pain Relief and Pain Relief PM Acetaminophen, Diphenhydramine HCl KIT 20070905 OTC MONOGRAPH FINAL part338 Amerisource Bergen 24385-988_7310f8f2-aaba-45c0-8add-d59b8fb7edda 24385-988 HUMAN OTC DRUG good neighbor pharmacy flu and severe cold daytime Acetaminophen, Phenylephrine hydrochloride POWDER, FOR SUSPENSION ORAL 20070821 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 650; 10 mg/16000mg; mg/16000mg 24385-998_f58ead80-748d-4ad8-8a4a-6fccd47f39bf 24385-998 HUMAN OTC DRUG good neighbor pharmacy all day allergy Cetirizine Hydrochloride TABLET ORAL 20080115 ANDA ANDA078336 Amerisource Bergen CETIRIZINE HYDROCHLORIDE 10 mg/1 24417-001_977772f9-0f6a-46bc-8c49-9c961ab4909d 24417-001 HUMAN PRESCRIPTION DRUG FLUDEOXYGLUCOSE F 18 FLUDEOXYGLUCOSE F-18 INJECTION INTRAVENOUS 20111212 ANDA ANDA203990 UIHC-P E T IMAGING CENTER FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 24438-001_fab49a9f-9c0f-4a00-81cf-c9bbd5ef0826 24438-001 HUMAN OTC DRUG Phoenix Balm Pain Relief Rub OINTMENT TOPICAL 20111201 OTC MONOGRAPH FINAL part348 Amazonian Naturals, Inc. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 50; 50; 50 mg/g; mg/g; mg/g 24439-321_4f92100f-6738-4fe2-9360-4b5b7e5e6900 24439-321 HUMAN OTC DRUG TopSani Benzalkonium Chloride LIQUID TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part333E United Promotions Inc. BENZALKONIUM CHLORIDE 1.25 mL/1000mL 24450-113_6fd639ce-dde7-475c-a63b-d5bf3f111a05 24450-113 HUMAN PRESCRIPTION DRUG AMMONIA N-13 AMMONIA N-13 INJECTION INTRAVENOUS 20141030 NDA NDA203783 Brigham and Women's Hospital, Inc., The AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 24450-647_9f114496-e309-40c6-b09f-56509525b4bb 24450-647 HUMAN PRESCRIPTION DRUG FLUDEOXYGLUCOSE F-18 FLUDEOXYGLUCOSE F-18 INJECTION INTRAVENOUS 20141030 ANDA ANDA203816 BRIGHAM AND WOMEN`S HOSPITAL, INC., THE FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 24451-001_5bc16ba0-117f-4f72-bd0f-43eb5ac3d7f0 24451-001 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20130624 ANDA ANDA077789 LLC Federal Solutions CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] 24451-002_38d13c4f-3921-4676-827d-146202172021 24451-002 HUMAN OTC DRUG FERROUS SULFATE FERROUS SULFATE ELIXIR ORAL 20130812 UNAPPROVED DRUG OTHER LLC Federal Solutions FERROUS SULFATE 220 mg/5mL 24451-008_46557d9b-ba31-4f41-9012-0f8452a58bfc 24451-008 HUMAN OTC DRUG Multi-Vitamin vitamin A, vitamin C, vitamin D, Vitamin E, thiamine, riboflavin, niacin, pyridoxine, and cyanocobalamin LIQUID ORAL 20130812 UNAPPROVED DRUG OTHER LLC Federal Solutions .ALPHA.-TOCOPHEROL; ASCORBIC ACID; CYANOCOBALAMIN; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D 13.5; 54; .00405; 12.2; .945; 1.08; .842; 2250; 360 [iU]/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; [iU]/5mL; [iU]/5mL 24451-091_18de8a4b-df09-498a-ab6b-df914a59e48a 24451-091 HUMAN OTC DRUG Aluminum Hydroxide Aluminum Hydroxide GEL ORAL 20130812 OTC MONOGRAPH FINAL part331 LLC Federal Solutions ALUMINUM HYDROXIDE 320 mg/5mL 24451-133_119a9192-39fa-47d6-b277-eb0ff6ce87db 24451-133 HUMAN OTC DRUG Guaifenesin and Dextromethorphan Hydrobromide Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 20130808 OTC MONOGRAPH FINAL part341 LLC Federal Solutions DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 24451-289_15ecc7ae-011e-421f-b315-c6dee70bda0f 24451-289 HUMAN OTC DRUG Senna SENNOSIDES A AND B SYRUP ORAL 20130812 OTC MONOGRAPH NOT FINAL part334 LLC Federal Solutions SENNOSIDES A AND B 8.8 mg/5mL 24451-548_1479dec5-5734-433b-898b-83d655c8a345 24451-548 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20130924 ANDA ANDA090263 LLC Federal Solutions LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 24451-725_182d5565-8aa9-493e-a24e-712433bc9302 24451-725 HUMAN OTC DRUG aluminum hydroxide, magnesium hydroxide, simethicone aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20130812 OTC MONOGRAPH FINAL part331 LLC Federal Solutions ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 24451-771_16a7177b-b651-4120-97f1-270295bcfa22 24451-771 HUMAN OTC DRUG DOCUSATE SODIUM DOCUSATE SODIUM LIQUID ORAL 20130808 OTC MONOGRAPH NOT FINAL part334 LLC Federal Solutions DOCUSATE SODIUM 50 mg/5mL 24451-775_277d0918-d9b2-4ef7-910f-8f700dac851c 24451-775 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL 20130624 ANDA ANDA040014 LLC Federal Solutions LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 24451-788_170fb7bb-356e-41e6-8d35-4515b130cefd 24451-788 HUMAN OTC DRUG Milk of Magnesia MAGNESIUM HYDROXIDE SUSPENSION ORAL 20130812 OTC MONOGRAPH NOT FINAL part334 LLC Federal Solutions MAGNESIUM HYDROXIDE 2400 mg/30mL 24453-198_cf9f6fbd-4e09-4429-985d-a179e4816217 24453-198 HUMAN OTC DRUG Flawless Tinted Moisturizer Light SPF 18 Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Anastasia Beverly Hills AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100g; g/100g; g/100g 24453-199_9e9219e9-b989-40d6-8fed-d6b652fc340a 24453-199 HUMAN OTC DRUG Flawless Tinted Moisturizer Medium SPF 18 Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Anastasia Beverly Hills AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100g; g/100g; g/100g 24453-200_3ec30d09-f034-466f-971c-3cea06779322 24453-200 HUMAN OTC DRUG Flawless Tinted Moisturizer Dark SPF 18 Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Anastasia Beverly Hills AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100g; g/100g; g/100g 24462-200_cc11fdde-5e58-488f-b736-176988e1f745 24462-200 HUMAN OTC DRUG MMA Elite Pain Relief menthol, camphor GEL TOPICAL 20111110 OTC MONOGRAPH NOT FINAL part348 MMA Pain Relief Gel, LLC CAMPHOR (NATURAL); MENTHOL 5; 5 g/100g; g/100g 24463-000_915d3bb6-a4c6-417f-9417-73f90567c41c 24463-000 HUMAN OTC DRUG Brighter By Nature SPF 30 octinoxate, titanium dioxide, octocrylene POWDER TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 JO Cosmetics Co., Ltd. OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE .075; .01; .03 g/g; g/g; g/g 24470-900_ae7ac690-4fe1-4361-941a-01ec6cc04dfd 24470-900 HUMAN OTC DRUG BP Wash BENZOYL PEROXIDE EMULSION TOPICAL 20111215 OTC MONOGRAPH FINAL part333D CINTEX SERVICES, LLC BENZOYL PEROXIDE 50 mg/g 24470-901_ceab6af4-a645-4b66-9b36-7e0f485c992d 24470-901 HUMAN OTC DRUG BP Wash BENZOYL PEROXIDE EMULSION TOPICAL 20120115 OTC MONOGRAPH FINAL part333D CINTEX SERVICES, LLC BENZOYL PEROXIDE 100 mg/g 24470-902_5aae5296-49dd-4c43-8216-cfe9dffb1c6a 24470-902 HUMAN OTC DRUG BP Wash BENZOYL PEROXIDE EMULSION TOPICAL 20110115 OTC MONOGRAPH FINAL part333D CINTEX SERVICES, LLC BENZOYL PEROXIDE 70 mg/mL 24470-906_c0b4ae23-c420-4b05-a240-08bf8c3988d5 24470-906 HUMAN OTC DRUG BP Wash Acne Treatment Pack BENZOYL PEROXIDE KIT 20110901 OTC MONOGRAPH FINAL part333D CINTEX SERVICES, LLC 24470-907_1645c68b-b2eb-4379-a69d-f251d8bbe768 24470-907 HUMAN OTC DRUG BP Wash Acne Treatment Pack BENZOYL PEROXIDE KIT 20110901 OTC MONOGRAPH FINAL part333D CINTEX SERVICES, LLC 24470-909_2493f01b-183e-4e64-bf3d-487ff2622e5b 24470-909 HUMAN OTC DRUG BENZOYL PEROXIDE BENZOYL PEROXIDE GEL TOPICAL 20120628 OTC MONOGRAPH FINAL part333D Cintex Services, LLC BENZOYL PEROXIDE 50 mg/g 24470-910_7f533b59-f276-4437-bb2c-a5a158ba0602 24470-910 HUMAN OTC DRUG BENZOYL PEROXIDE BENZOYL PEROXIDE GEL TOPICAL 20120628 OTC MONOGRAPH FINAL part333D Cintex Services, LLC BENZOYL PEROXIDE 100 mg/g 24470-911_cbafdbc7-aa07-44aa-9584-3bf5ad88e153 24470-911 HUMAN OTC DRUG BP Wash BENZOYL PEROXIDE EMULSION TOPICAL 20110815 OTC MONOGRAPH FINAL part333D CINTEX SERVICES, LLC BENZOYL PEROXIDE 25 mg/g 24470-912_a99b625d-0fce-4ea3-a9e0-b482bdc6789c 24470-912 HUMAN OTC DRUG Benzoyl Peroxide BENZOYL PEROXIDE AEROSOL, FOAM TOPICAL 20110304 OTC MONOGRAPH FINAL part333D Cintex Services, LLC BENZOYL PEROXIDE 53 mg/g 24470-913_0262b130-fa02-403f-ba28-1625ee8d0e75 24470-913 HUMAN OTC DRUG Benzoyl Peroxide BENZOYL PEROXIDE AEROSOL, FOAM TOPICAL 20110304 OTC MONOGRAPH FINAL part333D Cintex Services, LLC BENZOYL PEROXIDE 98 mg/g 24470-914_b712e7f8-17a1-42fb-a55b-0aad9a74a06e 24470-914 HUMAN OTC DRUG BPM-DM-PHEN BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20120601 OTC MONOGRAPH FINAL part341 Cintex Services, LLC BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/5mL; mg/5mL; mg/5mL 24471-200_f2d0e844-f3b5-8649-234b-26ca6cb97364 24471-200 HUMAN OTC DRUG Diabecline Tetracycline hydrochloride OINTMENT TOPICAL 20130523 OTC MONOGRAPH FINAL part333B THRU PHARMA, LLC TETRACYCLINE HYDROCHLORIDE 30 mg/mL 24474-001_c819ce36-7ffc-4b9f-b359-e90d334a3a5f 24474-001 HUMAN OTC DRUG Run Guard Original ALLANTOIN STICK TOPICAL 20120401 OTC MONOGRAPH FINAL part347 RunGuards LLC ALLANTOIN .5 g/100g 24474-002_f4edbc25-fcc0-45cb-a22a-4d2962e49542 24474-002 HUMAN OTC DRUG Run Guard Sensitive ALLANTOIN STICK TOPICAL 20120401 OTC MONOGRAPH FINAL part347 RunGuards LLC ALLANTOIN .5 g/100g 24477-030_2d1575a0-f64d-11df-96e3-0002a5d5c51b 24477-030 HUMAN PRESCRIPTION DRUG Cardene I.V. nicardipine hydrochloride INJECTION INTRAVENOUS 19920130 NDA NDA019734 EKR Therapeutics NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 24477-040_0fc7fdc0-fad0-11de-b508-0002a5d5c51b 24477-040 HUMAN PRESCRIPTION DRUG Retavase reteplase KIT 19961030 BLA BLA103786 EKR Therapeutics, Inc. 24477-041_0fc7fdc0-fad0-11de-b508-0002a5d5c51b 24477-041 HUMAN PRESCRIPTION DRUG Retavase reteplase KIT 19961030 BLA BLA103786 EKR Therapeutics, Inc. 24477-311_e2422520-e1ff-11df-9676-0002a5d5c51b 24477-311 HUMAN PRESCRIPTION DRUG Cardene I.V. nicardipine hydrochloride INJECTION, SOLUTION INTRAVENOUS 19920130 NDA NDA019734 EKR Therapeutics, Inc. NICARDIPINE HYDROCHLORIDE .1 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 24477-312_e2422520-e1ff-11df-9676-0002a5d5c51b 24477-312 HUMAN PRESCRIPTION DRUG Cardene I.V. nicardipine hydrochloride INJECTION, SOLUTION INTRAVENOUS 19920130 NDA NDA019734 EKR Therapeutics, Inc. NICARDIPINE HYDROCHLORIDE .1 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 24477-323_695dbdc0-e201-11df-bc20-0002a5d5c51b 24477-323 HUMAN PRESCRIPTION DRUG Cardene I.V. nicardipine hydrochloride INJECTION, SOLUTION INTRAVENOUS 19920130 NDA NDA019734 EKR Therapeutics, Inc. NICARDIPINE HYDROCHLORIDE .2 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 24477-324_695dbdc0-e201-11df-bc20-0002a5d5c51b 24477-324 HUMAN PRESCRIPTION DRUG Cardene I.V. nicardipine hydrochloride INJECTION, SOLUTION INTRAVENOUS 19920130 NDA NDA019734 EKR Therapeutics, Inc. NICARDIPINE HYDROCHLORIDE .2 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 24478-190_e89979d7-4293-4974-b0f6-eebc4976e59d 24478-190 HUMAN PRESCRIPTION DRUG Quillivant XR methylphenidate hydrochloride POWDER, FOR SUSPENSION ORAL 20121001 NDA NDA202100 NextWave Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 300 mg/60mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 24478-200_e89979d7-4293-4974-b0f6-eebc4976e59d 24478-200 HUMAN PRESCRIPTION DRUG Quillivant XR methylphenidate hydrochloride POWDER, FOR SUSPENSION ORAL 20121001 NDA NDA202100 NextWave Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 600 mg/120mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 24478-205_e89979d7-4293-4974-b0f6-eebc4976e59d 24478-205 HUMAN PRESCRIPTION DRUG Quillivant XR methylphenidate hydrochloride POWDER, FOR SUSPENSION ORAL 20130104 NDA NDA202100 NextWave Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 750 mg/150mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 24478-210_e89979d7-4293-4974-b0f6-eebc4976e59d 24478-210 HUMAN PRESCRIPTION DRUG Quillivant XR methylphenidate hydrochloride POWDER, FOR SUSPENSION ORAL 20121001 NDA NDA202100 NextWave Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 900 mg/180mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 24486-200_c55797d4-27ee-4735-b25e-fc2704931ef9 24486-200 HUMAN PRESCRIPTION DRUG Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Hydrocodone Polistirex and Chlorpheniramine Polistirex SUSPENSION, EXTENDED RELEASE ORAL 20120629 ANDA ANDA091671 Aristos Phamaceuticals, Inc. CHLORPHENIRAMINE; HYDROCODONE 8; 10 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CIII 24488-001_198d5e56-8559-42c1-a5be-35094578ae7d 24488-001 HUMAN OTC DRUG Pain Relieving Ultra Strength Camphor Menthol Methyl Salicylate CREAM TOPICAL 20100331 UNAPPROVED DRUG OTHER Creation's Garden Natural Products, Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 2.28; 5.7; 9 g/57g; g/57g; g/57g 24488-001_9eeb2e24-edb9-446f-93d6-aa1613ccd39a 24488-001 HUMAN OTC DRUG Pain Relieving Ultra Strength Camphor, Menthol and Methyl Salicylate CREAM TOPICAL 20100331 UNAPPROVED DRUG OTHER Creation's Garden Natural Products, Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4.52; 11.3; 33.9 g/113g; g/113g; g/113g 24488-001_b2afddf3-47c7-4277-91cc-dcae637ec9f4 24488-001 HUMAN OTC DRUG Pain Relieving Ultra Strength Camphor Menthol Methyl Salicylate CREAM TOPICAL 20100331 UNAPPROVED DRUG OTHER Creation's Garden Natural Products, Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 2.28; 5.7; 9 g/57g; g/57g; g/57g 24488-002_2478517e-a395-46f4-805f-81b8de8689d2 24488-002 HUMAN OTC DRUG Pain ReliefRoll On Roll On Methyl Salicylate Mentol Camphor Capsaicin LIQUID TOPICAL 20100310 UNAPPROVED DRUG OTHER Creations Garden Natural Products, Inc. CAMPHOR, (SYNTHETIC); MENTHOL; METHYL SALICYLATE 2.8; 7; 21 g/70g; g/70g; g/70g 24488-003_1d5a462a-a513-44f0-a832-08185e26c922 24488-003 HUMAN OTC DRUG Boy Butter Extreme H2O Desensitizing Lubricant Benzocaine CREAM TOPICAL 20110627 OTC MONOGRAPH FINAL part333B Boy Butter Lubes BENZOCAINE 4.25 g/85.05g 24488-003_65541c40-dd2b-414d-b60b-a8908d3261f5 24488-003 HUMAN OTC DRUG Boy Butter Extreme H2O Desensitizing Lubricant Benzocaine CREAM TOPICAL 20110627 OTC MONOGRAPH FINAL part333B Boy Butter Lubes BENZOCAINE 34.05 g/454g 24488-003_74fda1b5-5bd6-4930-a283-315ca5ab791d 24488-003 HUMAN OTC DRUG Boy Butter Extreme Desensitizing Lubricant Benzocaine CREAM TOPICAL 20110523 OTC MONOGRAPH FINAL part333B Boy Butter Lubes BENZOCAINE 34.05 g/454g 24488-003_b7e1fc03-6123-404b-ad83-03e6e144f0b6 24488-003 HUMAN OTC DRUG Boy Butter Desensitizing Lubricant Benzocaine CREAM TOPICAL 20110523 OTC MONOGRAPH FINAL part333B Boy Butter Lubes BENZOCAINE 6.39 g/85.2g 24488-003_bdf08eb0-ed3d-4ce9-81fc-4e9ec5680603 24488-003 HUMAN OTC DRUG Boy Butter Extreme H2O Desensitizing Lubricant Benzocaine CREAM TOPICAL 20110520 OTC MONOGRAPH FINAL part333B Boy Butter Lubes BENZOCAINE 7.1 g/142g 24488-003_e87bcc36-5037-4afd-b9a8-b8f3cfa78029 24488-003 HUMAN OTC DRUG Boy Butter Desensitizing Lubricant Benzocaine CREAM TOPICAL 20110523 OTC MONOGRAPH FINAL part333B Boy Butter Lubes BENZOCAINE 10.65 g/142g 24488-004_0a03c383-b407-4022-9396-4a5fa1d3397f 24488-004 HUMAN OTC DRUG Revitol Acne Treatment Benzoyl Peroxide CREAM TOPICAL 20110414 OTC MONOGRAPH NOT FINAL part333D Revitol Corporation BENZOYL PEROXIDE 2.95 mL/59mL 24488-005_1a1b6bc1-5db5-4580-a83a-d846d3808582 24488-005 HUMAN OTC DRUG Hand Sanitizer Prevail alcohol SPRAY TOPICAL 20100412 UNAPPROVED DRUG OTHER Creation's Garden Natural Products, Inc ALCOHOL 4.58 mL/7.39mL 24488-005_33e973a4-7957-4675-a8e8-9317100230fa 24488-005 HUMAN OTC DRUG Hand Sanitizer Prevail alcohol SPRAY TOPICAL 20100406 UNAPPROVED DRUG OTHER Creation's Garden Natural Products, Inc ALCOHOL 4.58 mL/7.39mL 24488-005_7fb28618-9d06-4277-90f3-9acc6d0af89b 24488-005 HUMAN OTC DRUG True Essentials Lemongrass Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20110310 OTC MONOGRAPH NOT FINAL part333E Fortune Hi-Tech ALCOHOL 36.58 mL/59mL 24488-005_9553b10b-47ac-474e-b528-ecfa348d14c2 24488-005 HUMAN OTC DRUG Hand Sanitizer Prevail alcohol SPRAY TOPICAL 20100412 UNAPPROVED DRUG OTHER Creation's Garden Natural Products, Inc ALCOHOL 4.58 mL/7.39mL 24488-005_ad1cec60-d57f-4392-b4f4-7b8f223e537b 24488-005 HUMAN OTC DRUG Creations Garden White Tea Quince Hand Sanitizer ethyl alcohol GEL TOPICAL 20110126 OTC MONOGRAPH NOT FINAL part333E Creations Garden Natural Products, Inc ALCOHOL 36.58 mL/59mL 24488-005_c11c6f77-f559-45f1-9c68-182d075b61d9 24488-005 HUMAN OTC DRUG Creations Garden Pomegranate Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20110125 OTC MONOGRAPH NOT FINAL part333A Creations Garden Natural Products, Inc ALCOHOL 36.58 mL/59mL 24488-005_d27b85e4-a6e2-482e-80e8-4243ee959c65 24488-005 HUMAN OTC DRUG Creations Garden Peach Hand Sanitizer ethyl alcohol GEL TOPICAL 20100423 OTC MONOGRAPH FINAL part333A Creation's Garden Natural Products, Inc ALCOHOL 36.58 mL/59mL 24488-006_0a4ad8c4-480e-421b-94ab-4dfbddb06762 24488-006 HUMAN OTC DRUG Creations Garden Hand Sanitizer BENZALKONIUM CHLORIDE LOTION TOPICAL 20110504 OTC MONOGRAPH NOT FINAL part333A Creations Garden Natural Products BENZALKONIUM CHLORIDE .59 mL/59mL 24488-006_0b54ddeb-883e-4fed-ac1d-fd567b4c3e68 24488-006 HUMAN OTC DRUG True Essentials Peach Hand Sanitizer BENZALKONIUM CHLORIDE CREAM TOPICAL 20110309 OTC MONOGRAPH NOT FINAL part333E Fortune Hi-Tech BENZALKONIUM CHLORIDE .059 mL/59mL 24488-006_321b53ad-4717-40be-ade0-2687c4ddf253 24488-006 HUMAN OTC DRUG True Essentials Hand Sanitizer BENZALKONIUM CHLORIDE LOTION TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part333E Fortune Hi-Tech BENZALKONIUM CHLORIDE .59 mL/59mL 24488-008_5d2b1d8d-55c7-4df2-b745-4c233056cfdf 24488-008 HUMAN OTC DRUG Roccos Old School Tattoo Balm Anti Bacterial Wash Triclosan LIQUID TOPICAL 20110228 OTC MONOGRAPH NOT FINAL part333A Rocco's Old School TRICLOSAN 3.54 mL/118mL 24488-009_260b397c-fd1e-4038-8e4a-a706ea78183e 24488-009 HUMAN OTC DRUG Roccos Old School Sunscreen SPF 30 Octinoxate CREAM TOPICAL 20110216 OTC MONOGRAPH NOT FINAL part352 Rocco's Old School OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 13.275; 10.62; 2.655 mL/177mL; mL/177mL; mL/177mL 24488-010_fe61b4b2-3575-4817-9f7c-166f7e84d82e 24488-010 HUMAN OTC DRUG Roccos Old School Healing Balm Zinc Oxide CREAM TOPICAL 20110217 OTC MONOGRAPH NOT FINAL part348 Roccos Old School ZINC OXIDE .9 mL/30mL 24488-011_a015ece3-75aa-45fc-9b3b-219fc87935cd 24488-011 HUMAN OTC DRUG Roccos Old School Peircing Armor Cetylpyridinium Chloride SPRAY TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part356 Rocco's Old School CETYLPYRIDINIUM CHLORIDE .027 mL/60mL 24488-013_a45214f1-bbe5-46f8-9de1-2630498ab9f8 24488-013 HUMAN OTC DRUG Wartrol Wart Remover Salicylic Acid LIQUID TOPICAL 20110901 OTC MONOGRAPH FINAL part358B Pacific Naturals SALICYLIC ACID 2.51 mL/14.78mL 24488-020_8d1a84b1-6378-43d4-b750-503b4dba43ab 24488-020 HUMAN OTC DRUG Prevail Pomegranate Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20110125 OTC MONOGRAPH NOT FINAL part333A Duane Reade ALCOHOL 36.58 mL/59mL 24488-020_cd01b928-4261-42e3-8d69-57dba001822e 24488-020 HUMAN OTC DRUG Prevail Pomegranate Hand Sanitizer ethyl alcohol GEL TOPICAL 20110126 OTC MONOGRAPH NOT FINAL part333E Duane Reade ALCOHOL 146.32 mL/236mL 24488-021_0b340153-fbc0-4b7d-a9e3-436d680ea5f3 24488-021 HUMAN OTC DRUG Prevail Hand Sanitizer Lemongrass alcohol GEL TOPICAL 20110126 OTC MONOGRAPH NOT FINAL part333E Duane Reade ALCOHOL 146.32 mL/236mL 24488-021_97c9f79e-c271-452b-be74-2aa3cd782145 24488-021 HUMAN OTC DRUG Prevail Hand Sanitizer Lemongrass alcohol GEL TOPICAL 20110126 OTC MONOGRAPH NOT FINAL part333E Creation's Garden Natural Products, Inc ALCOHOL 36.58 mL/59mL 24488-022_465710b3-5960-4588-b818-ea93d3296d6d 24488-022 HUMAN OTC DRUG Prevail White Tea Hand Sanitizer ethyl alcohol GEL TOPICAL 20110126 OTC MONOGRAPH NOT FINAL part333E Duane Reade ALCOHOL 146.32 mL/236mL 24488-022_eae1cbb9-a72f-4019-ae49-81e389efaa7f 24488-022 HUMAN OTC DRUG Prevail Hand Sanitizer White Tea alcohol GEL TOPICAL 20110126 OTC MONOGRAPH NOT FINAL part333E Creation's Garden Natural Products, Inc ALCOHOL 36.58 mL/59mL 24488-023_765259a5-6d84-4145-b9e3-3a6dd5206c4a 24488-023 HUMAN OTC DRUG Duane Reade hot and cold balm methyl salicylate and menthol SALVE TOPICAL 20110228 OTC MONOGRAPH NOT FINAL part348 Duane Reade MENTHOL; METHYL SALICYLATE 7.9; 30.16 mL/104mL; mL/104mL 24488-023_fcbcce35-b447-4d0e-b5e1-06afaee3f5ea 24488-023 HUMAN OTC DRUG Duane Reade hot and cold roll-on Methyl Salicylate and Menthol GEL TOPICAL 20110228 OTC MONOGRAPH NOT FINAL part348 Duane Reade MENTHOL; METHYL SALICYLATE 5.62; 21.46 mL/74mL; mL/74mL 24488-024_40c40495-b63b-4a7c-8d2d-0fc2ffe288fc 24488-024 HUMAN OTC DRUG True Essentials Pain Relief Roll On Camphor, Menthol, and Methyl Salicylate GEL TOPICAL 20100310 OTC MONOGRAPH FINAL part341 Fortune Hi-Tech Marketing, Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 2.96; 7.4; 22.2 mL/74mL; mL/74mL; mL/74mL 24488-024_e575497a-aac0-422f-996b-e1212f617ea8 24488-024 HUMAN OTC DRUG Creations Garden Pain Relief Roll On Camphor, Menthol, and Methyl Salicylate GEL TOPICAL 20100310 OTC MONOGRAPH FINAL part341 Creations Garden Natural Products, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 2.96; 7.4; 22.2 mL/74mL; mL/74mL; mL/74mL 24488-026_5aa64081-e673-49df-b108-26b6d7c9d86c 24488-026 HUMAN OTC DRUG MuscleCare Pain Relieving Camphor and Menthol GEL TOPICAL 20110623 OTC MONOGRAPH FINAL part341 Active and Innovative CAMPHOR (SYNTHETIC); MENTHOL .068; .17 g/1.7g; g/1.7g 24488-026_ad3b4c32-eff7-466a-91de-4b6bf1a0e5a1 24488-026 HUMAN OTC DRUG MuscleCare Professional Therapy Pain Relieving Camphor and Menthol GEL TOPICAL 20110621 OTC MONOGRAPH FINAL part341 Active and Innovative CAMPHOR (SYNTHETIC); MENTHOL 3.4; 8.5 g/85g; g/85g 24488-027_9f53086a-9bfe-4d9d-91da-4150504bd624 24488-027 HUMAN OTC DRUG Professional Therapy MuscleCare Diabetic Pain Relieving OINTMENT TOPICAL 20110602 OTC MONOGRAPH FINAL part341 Active and Innovative CAMPHOR (SYNTHETIC); MENTHOL 4.6; 4.6 g/115g; g/115g 24488-027_e7b642ab-f827-4165-a064-382431e74b9b 24488-027 HUMAN OTC DRUG MuscleCare Professional Therapy Pain Relieving Menthol and Camphor OINTMENT TOPICAL 20110621 OTC MONOGRAPH FINAL part341 Active and Innovative CAMPHOR (SYNTHETIC); MENTHOL 4.6; 4.6 g/115g; g/115g 24488-032_cc3fd08b-fc26-438f-933f-b0f1e508f181 24488-032 HUMAN OTC DRUG Duane Reade hydrocortisone plus 12 moisturizers hydrocortisone CREAM TOPICAL 20110328 OTC MONOGRAPH NOT FINAL part348 Duane Reade HYDROCORTISONE .284 g/287.4g 24488-033_c8c131c2-1345-47a0-9ea3-cf08ae04dc1b 24488-033 HUMAN OTC DRUG Duane Reade hydrocortisone hydrocortisone CREAM TOPICAL 20110318 OTC MONOGRAPH NOT FINAL part348 Duane Reade HYDROCORTISONE .284 g/28.4g 24488-034_0702c52c-8594-4a9d-8278-e924fa57e2b2 24488-034 HUMAN OTC DRUG Duane Reade hydrocortisone CREAM TOPICAL 20110321 OTC MONOGRAPH NOT FINAL part348 Duane Reade HYDROCORTISONE .284 g/28.4g 24488-035_1c45e0f4-9bb6-49f5-929c-e8fc7620e20f 24488-035 HUMAN OTC DRUG Duane Reade anti-itch DIPHENHYDRAMINE HYDROCHLORIDE CREAM TOPICAL 20110201 OTC MONOGRAPH FINAL part336 Duane Reade DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE ANHYDROUS .568; .284 g/28.4g; g/28.4g 24488-036_f119c979-2cfc-471d-91df-98a6cf4504fd 24488-036 HUMAN OTC DRUG Bio 2 Brazilian Heat Brazilian Heat Menthol LIQUID TOPICAL 20120315 OTC MONOGRAPH FINAL part341 Bio 2 MENTHOL 4.2 mL/60mL 24488-040_ae3fcc4e-4c22-4411-aa31-b6654141cb96 24488-040 HUMAN OTC DRUG KDS Lab Liquid Styptic LIDOCAINE HYDROCHLORIDE, ZINC CHLORIDE, ALCOHOL LIQUID TOPICAL 20121003 OTC MONOGRAPH NOT FINAL part348 KDS Lab ALCOHOL; LIDOCAINE HYDROCHLORIDE; ZINC CHLORIDE 199.975654; 39.9680796; 400.018936 mg/mL; mg/mL; mg/mL 24488-042_6d88ae7f-e65b-4922-ad03-e7ee347a7adb 24488-042 HUMAN OTC DRUG Boy Butter Desensitizing Lubricant Benzocaine CREAM TOPICAL 20120925 OTC MONOGRAPH FINAL part333B Boy Butter Lubes BENZOCAINE 73.9395789 mg/mL 24488-043_975672d1-cc6d-435d-b332-2e2deb94c221 24488-043 HUMAN OTC DRUG Boy Butter Desensitizing Lubricant Benzocaine CREAM TOPICAL 20120925 OTC MONOGRAPH FINAL part333B Boy Butter Lubes BENZOCAINE 71.9395789 mg/mL 24492-850_fc9174e2-7de8-4c29-abda-0e723438eb28 24492-850 HUMAN PRESCRIPTION DRUG Kitabis Pak Tobramycin SOLUTION RESPIRATORY (INHALATION) 20141202 NDA NDA205433 Pari Respiratory Equipment TOBRAMYCIN 300 mg/5mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 24509-0055_e2582716-c490-4126-8204-5ce76bf62272 24509-0055 HUMAN OTC DRUG DIOR SNOW PROTECTION UV WHITE REVEAL UV SHIELD TRANSLUCENT SPF 50 OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20100614 OTC MONOGRAPH NOT FINAL part352 NIPPON SHIKIZAI INC. OCTINOXATE; ZINC OXIDE 7.5; 19 g/100mL; g/100mL 24509-0056_e2582716-c490-4126-8204-5ce76bf62272 24509-0056 HUMAN OTC DRUG DIOR SNOW PROTECTION UV WHITE REVEAL UV SHIELD PEARLY WHITE SPF 50 OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 NIPPON SHIKIZAI INC. OCTINOXATE; ZINC OXIDE 7.5; 19 g/100mL; g/100mL 24509-0057_e2582716-c490-4126-8204-5ce76bf62272 24509-0057 HUMAN OTC DRUG DIOR SNOW PROTECTION UV WHITE REVEAL MAKEUP UV BASE SPF 35 BEIGE OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 NIPPON SHIKIZAI INC. OCTINOXATE; ZINC OXIDE 5.5; 15.75 g/100mL; g/100mL 24509-0058_e2582716-c490-4126-8204-5ce76bf62272 24509-0058 HUMAN OTC DRUG DIOR SNOW PROTECTION UV WHITE REVEAL MAKEUP UV BASE SPF 35 MAUVE OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 NIPPON SHIKIZAI INC. OCTINOXATE; ZINC OXIDE 5.5; 15.75 g/100mL; g/100mL 24533-001_44459b17-e96b-41be-a0b6-934ea7181797 24533-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20111128 UNAPPROVED MEDICAL GAS Melo's Gas and Gear, Inc. OXYGEN 990 mL/L 24533-002_a69fc716-2e2b-4ba8-8415-8ddec912fe45 24533-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20120501 UNAPPROVED MEDICAL GAS Melo's Gas and Gear, Inc. NITROGEN 990 mL/L 24559-001_cd8f178c-9d62-4440-8fc3-957d30a69ca8 24559-001 HUMAN OTC DRUG INTELLIGENT BEAUTY LABS Age Defying Day Broad Spectrum SPF 20 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20130125 OTC MONOGRAPH NOT FINAL part352 DermStore, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 20; 75; 46 mg/mL; mg/mL; mg/mL 24559-080_6fcb16e8-6223-41cf-9785-cacd1d29338d 24559-080 HUMAN OTC DRUG After Shave Broad Spectrum SPF 15 Avobenzone, Octocrylene, Phenylbenzimidazole Sulfonic Acid LOTION TOPICAL 20131219 OTC MONOGRAPH NOT FINAL part352 Dermstore, LLC AVOBENZONE; ENSULIZOLE; OCTOCRYLENE 3; 4; 2.7 g/100mL; g/100mL; g/100mL 24559-091_74574e7a-d9ff-4f34-bced-4104553c2271 24559-091 HUMAN OTC DRUG IQ Derma Essentials Life Without Wrinkles SPF 25 Ensulizole, Octinoxate, Oxybenzone, Zinc Oxide CREAM TOPICAL 20060501 OTC MONOGRAPH NOT FINAL part352 DermStore, LLC (Formerly Intelligent Beauty, LLC) ENSULIZOLE; OCTINOXATE; OXYBENZONE; ZINC OXIDE 2; 7.5; 4; 3 g/100g; g/100g; g/100g; g/100g 24559-228_23a3422f-65c2-48bf-a1f9-45981063d38c 24559-228 HUMAN OTC DRUG IQ Derma regiMEN Hydrating UV Shield SPF 25 Ensulizole, Octinoxate, Oxybenzone, Zinc Oxide CREAM TOPICAL 20060501 OTC MONOGRAPH NOT FINAL part352 DermStore, LLC (Formerly Intelligent Beauty, LLC) ENSULIZOLE; OCTINOXATE; OXYBENZONE; ZINC OXIDE 2; 7.5; 4; 3 g/100g; g/100g; g/100g; g/100g 24562-001_f0e4bd4b-19c9-4a17-9b76-92737351e140 24562-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F-18 INJECTION, SOLUTION INTRAVENOUS 20111212 UNAPPROVED DRUG OTHER Biomedical Research Foundation of Northwest Louisiana FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 24562-003_cdbce95a-e758-46df-8086-692fa2883040 24562-003 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F-18 INJECTION, SOLUTION INTRAVENOUS 20111212 UNAPPROVED DRUG OTHER Biomedical Research Foundation of Northwest Louisiana FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 24571-102_816c0444-c722-4e2b-81ae-2b42d4b51368 24571-102 HUMAN PRESCRIPTION DRUG PrismaSol BGK2/0 Magnesium Chloride, Dextrose monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Gambro Renal Products DEXTROSE MONOHYDRATE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 1; .27; .048; .149; 2.936; 6.137 g/L; g/L; g/L; g/L; g/L; g/L Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 24571-102_9dee7d36-d551-4f16-8eff-7dfcf70ed24c 24571-102 HUMAN PRESCRIPTION DRUG PrismaSol BGK2/0 Magnesium Chloride, Dextrose monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Gambro Renal Products DEXTROSE MONOHYDRATE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 1; .27; .048; .149; 2.936; 6.137 g/L; g/L; g/L; g/L; g/L; g/L Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 24571-103_816c0444-c722-4e2b-81ae-2b42d4b51368 24571-103 HUMAN PRESCRIPTION DRUG PrismaSol BGK2/3.5 Calcium Chloride, Magnesium Chloride, Dextrose monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Gambro Renal Products CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE .194; 1; .27; .048; .149; 2.936; 6.137 g/L; g/L; g/L; g/L; g/L; g/L; g/L Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 24571-103_9dee7d36-d551-4f16-8eff-7dfcf70ed24c 24571-103 HUMAN PRESCRIPTION DRUG PrismaSol BGK2/3.5 Calcium Chloride, Magnesium Chloride, Dextrose monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Gambro Renal Products CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE .194; 1; .27; .048; .149; 2.936; 6.137 g/L; g/L; g/L; g/L; g/L; g/L; g/L Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 24571-104_9dee7d36-d551-4f16-8eff-7dfcf70ed24c 24571-104 HUMAN PRESCRIPTION DRUG PrismaSol BGK4/3.5 Calcium Chloride, Magnesium Chloride, Dextrose monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Gambro Renal Products CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE .194; 1; .27; .048; .298; 2.936; 6.137 g/L; g/L; g/L; g/L; g/L; g/L; g/L Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 24571-105_816c0444-c722-4e2b-81ae-2b42d4b51368 24571-105 HUMAN PRESCRIPTION DRUG PrismaSol BGK4/2.5 Calcium Chloride, Magnesium Chloride, Dextrose monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Gambro Renal Products CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE .139; 1; .27; .071; .298; 2.936; 6.137 g/L; g/L; g/L; g/L; g/L; g/L; g/L Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 24571-105_9dee7d36-d551-4f16-8eff-7dfcf70ed24c 24571-105 HUMAN PRESCRIPTION DRUG PrismaSol BGK4/2.5 Calcium Chloride, Magnesium Chloride, Dextrose monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Gambro Renal Products CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE .139; 1; .27; .071; .298; 2.936; 6.137 g/L; g/L; g/L; g/L; g/L; g/L; g/L Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 24571-108_816c0444-c722-4e2b-81ae-2b42d4b51368 24571-108 HUMAN PRESCRIPTION DRUG PrismaSol BGK0/2.5 Calcium Chloride, Magnesium Chloride, Dextrose monohydrate, Lactic Acid, Sodium Chloride, and Sodium Bicarbonate SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Gambro Renal Products CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID; MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE .139; 1; .27; .071; 2.936; 6.137 g/L; g/L; g/L; g/L; g/L; g/L Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 24571-108_9dee7d36-d551-4f16-8eff-7dfcf70ed24c 24571-108 HUMAN PRESCRIPTION DRUG PrismaSol BGK0/2.5 Calcium Chloride, Magnesium Chloride, Dextrose monohydrate, Lactic Acid, Sodium Chloride, and Sodium Bicarbonate SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Gambro Renal Products CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID; MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE .139; 1; .27; .071; 2.936; 6.137 g/L; g/L; g/L; g/L; g/L; g/L Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 24571-111_816c0444-c722-4e2b-81ae-2b42d4b51368 24571-111 HUMAN PRESCRIPTION DRUG PrismaSol B22GK4/0 Magnesium Chloride, Dextrose monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride SOLUTION INTRAVENOUS 20081010 NDA NDA021703 Gambro Renal Products DEXTROSE MONOHYDRATE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 1; .27; .071; .298; 2.1; 6.717 g/L; g/L; g/L; g/L; g/L; g/L Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 24571-111_9dee7d36-d551-4f16-8eff-7dfcf70ed24c 24571-111 HUMAN PRESCRIPTION DRUG PrismaSol B22GK4/0 Magnesium Chloride, Dextrose monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride SOLUTION INTRAVENOUS 20081010 NDA NDA021703 Gambro Renal Products DEXTROSE MONOHYDRATE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 1; .27; .071; .298; 2.1; 6.717 g/L; g/L; g/L; g/L; g/L; g/L Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 24571-113_816c0444-c722-4e2b-81ae-2b42d4b51368 24571-113 HUMAN PRESCRIPTION DRUG PrismaSol BK0/0/1.2 Magnesium Chloride, Lactic Acid, Sodium Chloride, and Sodium Bicarbonate SOLUTION INTRAVENOUS 20081010 NDA NDA021703 Gambro Renal Products LACTIC ACID; MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE .27; .057; 2.936; 6.137 g/L; g/L; g/L; g/L Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 24571-113_9dee7d36-d551-4f16-8eff-7dfcf70ed24c 24571-113 HUMAN PRESCRIPTION DRUG PrismaSol BK0/0/1.2 Magnesium Chloride, Lactic Acid, Sodium Chloride, and Sodium Bicarbonate SOLUTION INTRAVENOUS 20081010 NDA NDA021703 Gambro Renal Products LACTIC ACID; MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE .27; .057; 2.936; 6.137 g/L; g/L; g/L; g/L Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 24571-114_816c0444-c722-4e2b-81ae-2b42d4b51368 24571-114 HUMAN PRESCRIPTION DRUG PrismaSol BGK4/0/1.2 Magnesium Chloride, Dextrose monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride SOLUTION INTRAVENOUS 20081010 NDA NDA021703 Gambro Renal Products DEXTROSE MONOHYDRATE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 1; .27; .057; .298; 2.936; 6.137 g/L; g/L; g/L; g/L; g/L; g/L Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 24571-114_9dee7d36-d551-4f16-8eff-7dfcf70ed24c 24571-114 HUMAN PRESCRIPTION DRUG PrismaSol BGK4/0/1.2 Magnesium Chloride, Dextrose monohydrate, Lactic Acid, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride SOLUTION INTRAVENOUS 20081010 NDA NDA021703 Gambro Renal Products DEXTROSE MONOHYDRATE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 1; .27; .057; .298; 2.936; 6.137 g/L; g/L; g/L; g/L; g/L; g/L Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 24596-000_1902f968-77a6-4f22-8aeb-43ab35e47c8f 24596-000 HUMAN PRESCRIPTION DRUG OXYGEN COMPRESSED OXYGEN GAS RESPIRATORY (INHALATION) 20111121 UNAPPROVED MEDICAL GAS McFarland Group, Inc. OXYGEN 1 L/L 24598-0121_9e92ff57-b91e-4604-9f84-7094584dc4fc 24598-0121 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060513 UNAPPROVED MEDICAL GAS Special Care Medical OXYGEN 99 L/100L 24600-6407_07c983ae-a9ad-4e5b-b665-c08ddc8b99ef 24600-6407 HUMAN OTC DRUG MORTON Natural Epsom Salt MAGNESIUM SULFATE GRANULE, FOR SOLUTION ORAL; TOPICAL 20120901 OTC MONOGRAPH FINAL part334 Morton Salt, Inc. MAGNESIUM SULFATE 1 kg/kg 24623-001_87cf3278-1d2b-4c3c-8fd8-d1ab091b0929 24623-001 HUMAN OTC DRUG Advanced Protection SPF-15 OCTINOXATE and Zinc Oxide CREAM TOPICAL 20010825 OTC MONOGRAPH NOT FINAL part352 CBI Laboratories, Inc OCTINOXATE; ZINC OXIDE .075; .05 g/g; g/g 24623-042_bb41140c-ef5b-4c97-96a2-4a0af804f5e1 24623-042 HUMAN OTC DRUG Advanced Lightning OCTINOXATE and HYDROQUINONE CREAM TOPICAL 20050701 OTC MONOGRAPH NOT FINAL part352 CBI Laboratories, Inc HYDROQUINONE; OCTINOXATE .02; .02 g/g; g/g 24623-044_5c06014f-55bf-4461-a3b7-1e6f37c84e77 24623-044 HUMAN OTC DRUG R-044 Blemish Fix SALICYLIC ACID LIQUID TOPICAL 20060328 OTC MONOGRAPH FINAL part333D CBI Laboratories, Inc SALICYLIC ACID 2 mg/mL 24623-047_d03ca55c-0dd2-43c2-ad09-94238998b2b9 24623-047 HUMAN OTC DRUG Tinted Moisturizer SPF20 Light OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20070401 OTC MONOGRAPH NOT FINAL part352 CBI Laboratories, Inc OCTINOXATE; TITANIUM DIOXIDE .05; .037 g/g; g/g 24623-048_be6b98e6-a896-4556-a3dc-d372afc70f4a 24623-048 HUMAN OTC DRUG Tinted Moisturizer SPF20 Medium OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20070401 OTC MONOGRAPH NOT FINAL part352 CBI Laboratories, Inc OCTINOXATE; TITANIUM DIOXIDE .05; .042 g/g; g/g 24623-049_05d0592d-18b2-4f2f-8ac2-476748e97b1d 24623-049 HUMAN OTC DRUG Tinted Moisturizer SPF20 Dark OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20070401 OTC MONOGRAPH NOT FINAL part352 CBI Laboratories, Inc OCTINOXATE; TITANIUM DIOXIDE .05; .042 g/g; g/g 24653-011_77ae783e-cda1-4c8b-9c25-d3d3a9fd8a3a 24653-011 HUMAN OTC DRUG Optimal Tinted Complexion ethylhexl methoxycinnamate CREAM TOPICAL 20120920 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE 3.5 g/50mL 24653-270_17e64293-87d8-42db-a080-5ded3be0d591 24653-270 HUMAN OTC DRUG CC Cream Light Octocrylene and Octinoxate CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE; OCTOCRYLENE 2.25; 3 g/30mL; g/30mL 24653-271_17e64293-87d8-42db-a080-5ded3be0d591 24653-271 HUMAN OTC DRUG CC Cream Medium Octocrylene and Octinoxate CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE; OCTOCRYLENE 2.25; 3 g/30mL; g/30mL 24653-282_03f16424-f02a-4ab7-8a1d-f5e9fb0fc870 24653-282 HUMAN OTC DRUG BB Cream Titanium Dioxide CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH TITANIUM DIOXIDE 3.42 g/30mL 24653-286_feced253-c701-418c-a09b-71814671bdc4 24653-286 HUMAN OTC DRUG BB Cream Medium Titanium Dioxide CREAM TOPICAL 20140210 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH TITANIUM DIOXIDE 3.42 g/30mL 24653-310_aebad75e-f667-4806-a5aa-e9bd0576fc28 24653-310 HUMAN OTC DRUG Melafadin Day Protection Titanium Dioxide, Octinoxate, Octocrylene CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 1.8; 2.25; .3 g/50mL; g/50mL; g/50mL 24653-800_710340a0-3f2f-4355-8851-03998a2ba8a4 24653-800 HUMAN OTC DRUG Long Last Makeup 00 Octinoxate CREAM TOPICAL 20121005 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE 1.8 g/30mL 24653-801_710340a0-3f2f-4355-8851-03998a2ba8a4 24653-801 HUMAN OTC DRUG Long Last Makeup 01 Octinoxate CREAM TOPICAL 20081010 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE 1.8 g/30mL 24653-802_710340a0-3f2f-4355-8851-03998a2ba8a4 24653-802 HUMAN OTC DRUG Long Last Makeup 05 Octinoxate CREAM TOPICAL 20120110 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE 1.8 g/30mL 24653-803_710340a0-3f2f-4355-8851-03998a2ba8a4 24653-803 HUMAN OTC DRUG Long Last Makeup 03 Octinoxate CREAM TOPICAL 20081010 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE 1.8 g/30mL 24653-805_2fe6a69b-2f80-49f0-818c-4912d6302c91 24653-805 HUMAN OTC DRUG Long Last Make UP 02 (Neo Heliopan) Ethylhexyl methoxycinnamate CREAM TOPICAL 20081010 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE 6 mL/30mL 24653-816_4b0df926-8098-428f-bea5-8e264cbd5e32 24653-816 HUMAN OTC DRUG FACE GUARD 15 Titanium Dioxide CREAM TOPICAL 20121002 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH TITANIUM DIOXIDE 4.2 g/100mL 24653-830_844d4da2-b598-4b01-9703-4cb614ceff28 24653-830 HUMAN OTC DRUG Face Guard 30 SPF Octinoxate and titanium dioxide CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE; TITANIUM DIOXIDE 3.5; .5 g/50mL; g/50mL 24658-110_e15db90b-bc8b-4b73-bc39-3d7e9f371766 24658-110 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20101101 ANDA ANDA090035 Blu Pharmaceuticals, LLC FOLIC ACID 1 mg/1 24658-130_c5f960a2-9892-43d4-810f-c4c3867de866 24658-130 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20070102 ANDA ANDA077836 Blu Pharmaceuticals, LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 24658-140_8d55c4d2-c3aa-44eb-a86a-93a24004fa52 24658-140 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20070403 ANDA ANDA077534 Blu Pharmaceuticals, LLC CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 24658-141_8d55c4d2-c3aa-44eb-a86a-93a24004fa52 24658-141 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20070403 ANDA ANDA077534 Blu Pharmaceuticals, LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 24658-142_8d55c4d2-c3aa-44eb-a86a-93a24004fa52 24658-142 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20070403 ANDA ANDA077534 Blu Pharmaceuticals, LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 24658-162_0bb7ba90-bb61-4650-8026-ab76766e8623 24658-162 HUMAN PRESCRIPTION DRUG ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET ORAL 20130205 ANDA ANDA090258 Blu Pharmaceuticals, LLC ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 24658-163_0bb7ba90-bb61-4650-8026-ab76766e8623 24658-163 HUMAN PRESCRIPTION DRUG ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET ORAL 20130205 ANDA ANDA090258 Blu Pharmaceuticals, LLC ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 24658-210_13a78e8e-3cc6-4025-93cc-2f5d17872f07 24658-210 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080201 ANDA ANDA076285 Blu Pharmaceuticals, LLC SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 24658-211_13a78e8e-3cc6-4025-93cc-2f5d17872f07 24658-211 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080201 ANDA ANDA076285 Blu Pharmaceuticals, LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 24658-212_13a78e8e-3cc6-4025-93cc-2f5d17872f07 24658-212 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080201 ANDA ANDA076285 Blu Pharmaceuticals, LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 24658-213_13a78e8e-3cc6-4025-93cc-2f5d17872f07 24658-213 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080201 ANDA ANDA076285 Blu Pharmaceuticals, LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 24658-214_13a78e8e-3cc6-4025-93cc-2f5d17872f07 24658-214 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080201 ANDA ANDA076285 Blu Pharmaceuticals, LLC SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 24658-220_32e47e51-28e4-445e-a806-8b02cf97e021 24658-220 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20100501 ANDA ANDA065095 Blu Pharmaceuticals, LLC DOXYCYCLINE HYCLATE 100 mg/1 24658-240_ab5c4088-d4f9-45fd-b7bf-067ccfb4c7ec 24658-240 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20090202 ANDA ANDA076063 Blu Pharmaceuticals, LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 24658-241_ab5c4088-d4f9-45fd-b7bf-067ccfb4c7ec 24658-241 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20090202 ANDA ANDA076063 Blu Pharmaceuticals, LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 24658-242_ab5c4088-d4f9-45fd-b7bf-067ccfb4c7ec 24658-242 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20090202 ANDA ANDA076063 Blu Pharmaceuticals, LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 24658-243_ab5c4088-d4f9-45fd-b7bf-067ccfb4c7ec 24658-243 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20090202 ANDA ANDA076063 Blu Pharmaceuticals, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 24658-244_ab5c4088-d4f9-45fd-b7bf-067ccfb4c7ec 24658-244 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20090202 ANDA ANDA076063 Blu Pharmaceuticals, LLC LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 24658-245_ab5c4088-d4f9-45fd-b7bf-067ccfb4c7ec 24658-245 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20090202 ANDA ANDA076063 Blu Pharmaceuticals, LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 24658-250_227619c7-1895-434b-b4be-c0ce41aa3998 24658-250 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Blu Pharmaceuticals, LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 24658-260_95d9f0ae-843f-48e9-afcb-b10b28522405 24658-260 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20110401 ANDA ANDA078012 Blu Pharmaceuticals, LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 24658-290_ea48afa1-eabb-4060-9012-275f5e4d8b27 24658-290 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20130903 ANDA ANDA078170 Blu Pharmaceuticals, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 24658-291_ea48afa1-eabb-4060-9012-275f5e4d8b27 24658-291 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20130903 ANDA ANDA078170 Blu Pharmaceuticals, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 24658-292_ea48afa1-eabb-4060-9012-275f5e4d8b27 24658-292 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20130903 ANDA ANDA078170 Blu Pharmaceuticals, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 24658-300_cd715610-e3c7-4f40-b39f-a8607bcfc9f8 24658-300 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111017 ANDA ANDA078034 Blu Pharmaceuticals, LLC SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 24658-301_cd715610-e3c7-4f40-b39f-a8607bcfc9f8 24658-301 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111017 ANDA ANDA078034 Blu Pharmaceuticals, LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 24658-302_cd715610-e3c7-4f40-b39f-a8607bcfc9f8 24658-302 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111017 ANDA ANDA078034 Blu Pharmaceuticals, LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 24658-303_cd715610-e3c7-4f40-b39f-a8607bcfc9f8 24658-303 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111017 ANDA ANDA078034 Blu Pharmaceuticals, LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 24658-304_cd715610-e3c7-4f40-b39f-a8607bcfc9f8 24658-304 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111017 ANDA ANDA078034 Blu Pharmaceuticals, LLC SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 24658-312_6eb4086c-eec7-4d25-9b73-ea9c50dbf73d 24658-312 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20131125 ANDA ANDA062269 Blu Pharmaceuticals, LLC DOXYCYCLINE HYCLATE 100 mg/1 24663-000_e74801d8-0dc5-47f1-bb3a-5ed4677bf3ae 24663-000 HUMAN OTC DRUG 29 by LYDIA MONDAVI Napa Valley BROAD SPECTRUM SPF 30 D VINE DAY AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20131016 OTC MONOGRAPH NOT FINAL part352 29 Luxury Goods, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 20; 25 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 24670-0001_a4a6564c-9252-46d0-acab-8ba7bc8494d7 24670-0001 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20130211 UNAPPROVED MEDICAL GAS Line Pressure NITROGEN 99 L/100L 24673-247_12af8eb4-2905-49d6-bbab-fc5f5f539d29 24673-247 HUMAN OTC DRUG Derma-Glove Triclosan SOAP TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part333 RWM TECHNOLOGIES TRICLOSAN .03 g/g 24673-248_77453def-d7fa-4cb6-8aaa-58c41de3cb58 24673-248 HUMAN OTC DRUG Derma-Glove Ethanol, Triclosan GEL TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part333 RWM TECHNOLOGIES ETHANOL; TRICLOSAN .58; .03 g/g; g/g 24673-249_d3894ea4-022f-41b4-b1d2-59e0fcaef923 24673-249 HUMAN OTC DRUG Derma-Glove Ethanol, Triclosan SPRAY TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part333 RWM TECHNOLOGIES ETHANOL; TRICLOSAN .58; .003 g/g; g/g 24694-001_476a18fd-9ef2-4188-830e-e283464ec620 24694-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19980101 UNAPPROVED MEDICAL GAS Greenville Truck and Welding Supplies LLC OXYGEN 99 L/100L 24724-028_9e4deae4-c73a-4d5f-94bf-a7ca02a813ad 24724-028 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL TABLET, FILM COATED ORAL 20110615 ANDA ANDA201634 INDICUS PHARMA LLC DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 24724-029_9e4deae4-c73a-4d5f-94bf-a7ca02a813ad 24724-029 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL TABLET, FILM COATED ORAL 20110615 ANDA ANDA201634 INDICUS PHARMA LLC DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 24724-030_f0d36846-d476-4206-99e7-51c7ae6b650a 24724-030 HUMAN PRESCRIPTION DRUG LETROZOLE LETROZOLE TABLET ORAL 20110615 ANDA ANDA201804 INDICUS PHARMA LLC LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 24765-100_edb22a90-fd3a-4510-aa55-af050daf0220 24765-100 HUMAN OTC DRUG Dental Clear Natural SODIUM FLUORIDE RINSE ORAL 20111201 OTC MONOGRAPH FINAL part355 Pharmacal-International. Co., Ltd. SODIUM FLUORIDE .05 mL/100mL 24765-101_5f64d680-59ec-4e76-bcdf-f98d6b55afd5 24765-101 HUMAN OTC DRUG Olidental Check Gargle SODIUM FLUORIDE RINSE ORAL 20111201 OTC MONOGRAPH FINAL part355 Pharmacal-International. Co., Ltd. SODIUM FLUORIDE .0154 g/770mL 24781-0001_7aa76967-8f9f-4d38-8389-1723c0a00212 24781-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060919 UNAPPROVED MEDICAL GAS Apollo Services Inc. OXYGEN 99 L/100L 24794-100_183603d9-76ff-470e-bdaa-0d8d05b36bd4 24794-100 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g 24794-101_5fb7bd21-20c7-49b2-8d91-67622a93fa70 24794-101 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g 24794-102_3068a828-d640-43f6-bb5f-dbe84d96b513 24794-102 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g 24794-103_82c1aa80-f571-4765-b6db-d93551a2f49b 24794-103 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g 24794-104_8f870200-cdd2-4e65-b8c0-8b7103c554de 24794-104 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g 24794-105_fb43c8f0-bd3a-487c-9571-da31319a310b 24794-105 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g 24794-106_79bfd1ee-8eab-4620-832e-dbf39b1ed5bb 24794-106 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g 24794-107_26711c81-b4c4-49f0-bc31-0943a794d8b5 24794-107 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g 24794-108_4ce99d27-b593-404c-a78b-054051f29a93 24794-108 HUMAN PRESCRIPTION DRUG Zap Neutral Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 4.086 g/454g 24794-109_47860995-2be6-4872-9798-4709ae6ec736 24794-109 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g 24794-220_afca2836-d504-4ea4-bf7e-607356b7f21f 24794-220 HUMAN OTC DRUG Gumnumb Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Crosstex International Inc. BENZOCAINE 200 mg/g 24794-221_4cfa36ca-65b2-4419-b784-99d5cfc600e9 24794-221 HUMAN OTC DRUG Gumnumb Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Crosstex International Inc. BENZOCAINE 200 mg/g 24794-222_a6a92bc4-82e1-4b31-9808-0d4d796a3828 24794-222 HUMAN OTC DRUG Gumnumb Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Crosstex International Inc. BENZOCAINE 200 mg/g 24794-223_69987821-5f54-4095-bc2e-f3f917c2b093 24794-223 HUMAN OTC DRUG Gumnumb Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Crosstex International Inc. BENZOCAINE 200 mg/g 24794-224_53d09d61-6e84-4000-8d3a-0b1d10ff5335 24794-224 HUMAN OTC DRUG Gumnumb Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Crosstex International Inc. BENZOCAINE 200 mg/g 24794-225_5918ab45-795c-4e18-b667-71a42d31a281 24794-225 HUMAN OTC DRUG Gumnumb Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Crosstex International Inc. BENZOCAINE 200 mg/g 24794-300_c7a49d05-f838-4471-b373-7a87dbf82c95 24794-300 HUMAN PRESCRIPTION DRUG Hemostatic Solution Aluminum Chloride SOLUTION DENTAL 20130115 UNAPPROVED DRUG OTHER Crosstex International Inc. ALUMINUM CHLORIDE 7500 mg/30mL 24839-343_aa7da2a8-cf88-46d5-8122-723a658afcf4 24839-343 HUMAN OTC DRUG NOTUSS PE Codeine Phosphate, Phenylephrine Hydrochloride LIQUID ORAL 20090716 OTC MONOGRAPH FINAL part341 SJ Pharmaceuticals, LLC CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE 10; 10 mg/5mL; mg/5mL CV 24839-346_2251d5a4-6d02-4fbb-8872-7c1e19585d7a 24839-346 HUMAN PRESCRIPTION DRUG Ryneze Liquid Chlorpheniramine maleate, Scopolamine Methyl Nitrate LIQUID ORAL 20090709 UNAPPROVED OTHER SJ Pharmaceuticals, LLC CHLORPHENIRAMINE MALEATE; METHSCOPOLAMINE NITRATE 4; 1.25 mg/5mL; mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 24839-348_d5481822-31d7-46f5-aba7-d49c13a12c48 24839-348 HUMAN PRESCRIPTION DRUG Notuss-NXD Codeine Phosphate, Pseudoephedrine HCl, Chlorcyclizine HCl LIQUID ORAL 20101103 UNAPPROVED DRUG OTHER SJ PHARMACEUTICALS, LLC CHLORCYCLIZINE HYDROCHLORIDE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 9.375; 10; 30 mg/5mL; mg/5mL; mg/5mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 24839-349_9c2d4b44-a2e1-4aa3-9ad9-1853670f218d 24839-349 HUMAN PRESCRIPTION DRUG Notuss-NX Codeine Phosphate, Chlorcyclizine HCl LIQUID ORAL 20101103 UNAPPROVED DRUG OTHER SJ PHARMACEUTICALS, LLC CHLORCYCLIZINE HYDROCHLORIDE; CODEINE PHOSPHATE 9.375; 10 mg/5mL; mg/5mL 24839-699_83b1a11a-dd01-4dc6-aaac-ad33aba4017a 24839-699 HUMAN PRESCRIPTION DRUG UTA Methenamine, Sodium Phosphate Monobasic, Methylene Blue, Hyoscyamine Sulfate CAPSULE ORAL 20140926 UNAPPROVED DRUG OTHER SJ PHARMACEUTICALS, LLC HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; SODIUM PHOSPHATE, MONOBASIC .12; 120; 10; 40.8 mg/170.92mg; mg/170.92mg; mg/170.92mg; mg/170.92mg 24839-777_0c51a0bb-4771-40ba-916d-e8c6d8596083 24839-777 HUMAN OTC DRUG BIDEX-400 Guaifenesin TABLET ORAL 20121109 OTC MONOGRAPH FINAL part341 SJ Pharmaceuticals GUAIFENESIN 400 mg/1 24842-132_78c34f1b-7308-4f71-824e-5b6c3d140d17 24842-132 HUMAN OTC DRUG Beyond Belief Vita C SPF 15 Daily Moisture OCTINOXATE and OXYBENZONE CREAM TOPICAL 20090721 OTC MONOGRAPH NOT FINAL part352 Brentwood Beauty Laboratories International, Inc. OCTINOXATE; OXYBENZONE 75; 45 mg/g; mg/g 24846-0001_2de3432f-0284-4ecf-aa1b-19804f017641 24846-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060926 UNAPPROVED MEDICAL GAS Wilkinson Pharmacy, Inc. OXYGEN 99 L/100L 24854-300_54e717a9-f442-48a5-8aac-eee89f00746d 24854-300 HUMAN OTC DRUG retrospect day shield broad spectrum SPF 25 octinoxate, avobenzone, and octocrylene LOTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part352 Keraplast Technologies LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE .15; .25; .4 g/50mL; g/50mL; g/50mL 24854-400_54e717a9-f442-48a5-8aac-eee89f00746d 24854-400 HUMAN OTC DRUG keras day shield broad spectrum SPF 25 octinoxate, avobenzone, and octocrylene LOTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part352 Keraplast Technologies LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE .15; .25; .4 g/50mL; g/50mL; g/50mL 24856-001_8d217460-006e-11e4-9191-0800200c9a66 24856-001 HUMAN PRESCRIPTION DRUG JETREA ocriplasmin INJECTION, SOLUTION INTRAVITREAL 20121031 BLA BLA125422 ThromboGenics Inc. OCRIPLASMIN .5 mg/.2mL 24882-325_0e7b8743-e29f-45bd-90a8-f023d7813eed 24882-325 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060927 UNAPPROVED MEDICAL GAS Fairbanks Memorial Hospital- Home Medical Equipment OXYGEN 99 L/100L 24887-001_3c0b0058-dc25-48e9-be57-0071d332881f 24887-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS Superior Oxygen & Medical Equipment OXYGEN 99 L/100L 24909-100_0ce274aa-1514-41cc-9b08-4aadf7d1f2b5 24909-100 HUMAN OTC DRUG Terrasil Jock-Itch Treatment MAX Clotrimazole OINTMENT TOPICAL 20140512 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC CLOTRIMAZOLE 1 g/100g 24909-102_8f9fc4aa-8a05-45fe-8fb4-8710b7a8170e 24909-102 HUMAN OTC DRUG Terrasil Ringworm Treatment MAX Clotrimazole OINTMENT TOPICAL 20140512 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC CLOTRIMAZOLE 1 g/100g 24909-104_6d3d9bd5-5fe1-4f2e-8a47-46483ebaf5ec 24909-104 HUMAN OTC DRUG Terrasil Tinea Treatment MAX Clotrimazole OINTMENT TOPICAL 20140512 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC CLOTRIMAZOLE 1 g/100g 24909-106_d91213e4-8254-4d58-8436-cbd1520f0965 24909-106 HUMAN OTC DRUG Terrasil Anti-Fungal Treatment MAX Clotrimazole OINTMENT TOPICAL 20120907 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC CLOTRIMAZOLE 1 g/100g 24909-107_4ee266cf-f37d-4a5e-aaf3-4919fbea573c 24909-107 HUMAN OTC DRUG TERRASIL ANTI-FUNGAL TREATMENT Clotrimazole 1.0% OINTMENT TOPICAL 20120126 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC CLOTRIMAZOLE 1 g/100g 24909-108_93c24e14-1d93-4426-ad42-53b920f3c5c3 24909-108 HUMAN OTC DRUG Terrasil Cold Sore Treatment MAX Allantoin, Benzalkonium Chloride OINTMENT TOPICAL 20120907 OTC MONOGRAPH NOT FINAL part333A Aidance Skincare & Topical Solutions, LLC ALLANTOIN; BENZALKONIUM CHLORIDE 1; .13 g/100g; g/100g 24909-109_86f31e92-c25a-465d-bb5b-cf63894a6866 24909-109 HUMAN OTC DRUG Terrasil Cold Sore Treatment Allantoin, Benzalkonium Chloride OINTMENT TOPICAL 20120907 OTC MONOGRAPH NOT FINAL part333A Aidance Skincare & Topical Solutions, LLC ALLANTOIN; BENZALKONIUM CHLORIDE .5; .1 g/100g; g/100g 24909-110_70130d9a-459a-430e-b323-47ee902dcb55 24909-110 HUMAN OTC DRUG TERRASIL COLD SORE TREATMENT MAX Allantoin 1.0%, Lidocaine 1.0% OINTMENT TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC ALLANTOIN; LIDOCAINE 1; 1 g/100g; g/100g 24909-111_579aaa85-d6f2-44d0-bf13-89f33a448541 24909-111 HUMAN OTC DRUG Terrasil Wart Removal Salicylic Acid STICK TOPICAL 20120907 OTC MONOGRAPH FINAL part358B Aidance Skincare & Topical Solutions, LLC SALICYLIC ACID 12 g/100g 24909-112_6b4b4105-073b-4b85-ae7f-f8412c6b7c05 24909-112 HUMAN OTC DRUG Terrasil Wart Removal MAX Salicylic Acid STICK TOPICAL 20120907 OTC MONOGRAPH FINAL part358B Aidance Skincare & Topical Solutions, LLC SALICYLIC ACID 15 g/100g 24909-113_b123b66a-a506-4ca4-8192-b0b4d1f2ce5b 24909-113 HUMAN OTC DRUG Terrasil Wart Treatment Thuja Occidentalis OINTMENT TOPICAL 20120919 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/g 24909-114_5a388f0b-5e1c-4eea-8e2d-9ec8608a3d80 24909-114 HUMAN OTC DRUG Terrasil Wart Treatment Maximum Strength Thuja Occidentalis OINTMENT TOPICAL 20120919 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC THUJA OCCIDENTALIS LEAFY TWIG 3 [hp_X]/g 24909-115_9b99ecd7-1547-4149-8e7a-4ab4ead90228 24909-115 HUMAN OTC DRUG TERRASIL WOUND CARE Allantoin 0.5%, Benzethonium Chloride 0.5% OINTMENT TOPICAL 20120120 OTC MONOGRAPH NOT FINAL part347 Aidance Skincare & Topical Solutions, LLC ALLANTOIN; BENZETHONIUM CHLORIDE .5; .5 g/100g; g/100g 24909-116_95ecbcb0-aba4-4d73-91e4-3416eb040376 24909-116 HUMAN OTC DRUG Terrasil Wound Care MAX Allantoin, Benzethonium Chloride OINTMENT TOPICAL 20120907 OTC MONOGRAPH NOT FINAL part347 Aidance Skincare & Topical Solutions, LLC ALLANTOIN; BENZETHONIUM CHLORIDE 1; .2 g/100g; g/100g 24909-117_f076c392-c3a0-4938-90a9-1f77611fff61 24909-117 HUMAN OTC DRUG Terrasil Wound Care Allantoin, Benzethonium Chloride OINTMENT TOPICAL 20120907 OTC MONOGRAPH NOT FINAL part347 Aidance Skincare & Topical Solutions, LLC ALLANTOIN; BENZETHONIUM CHLORIDE .5; .1 g/100g; g/100g 24909-118_3a18e0c8-29a5-4b65-a9e0-f0c265a4d78d 24909-118 HUMAN OTC DRUG Terrasil Fissures Formula Cocoa Butter OINTMENT TOPICAL 20140610 OTC MONOGRAPH FINAL part346 Aidance Skincare & Topical Solutions, LLC COCOA BUTTER 50 g/100g 24909-119_d5f99840-1a9e-425f-afa0-7b553d979524 24909-119 HUMAN OTC DRUG Terrasil Balanitis Relief Sulfur, Symphytum Officinale (Comfrey) OINTMENT TOPICAL 20140610 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC SULFUR; SYMPHYTUM OFFICINALE WHOLE 1; 1 [hp_X]/g; [hp_X]/g 24909-120_9737ce92-19b4-4933-8c34-ad1d0891998e 24909-120 HUMAN OTC DRUG Terrasil Boil Pain Relief Benzocaine OINTMENT TOPICAL 20140620 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC BENZOCAINE 3.5 g/100g 24909-123_a1215ce9-feb3-4f72-956c-72f622b346c7 24909-123 HUMAN OTC DRUG Terrasil Itch, Rash and Pain Relief Allantoin, Lidocaine OINTMENT TOPICAL 20120907 OTC MONOGRAPH FINAL part347 Aidance Skincare & Topical Solutions, LLC ALLANTOIN; LIDOCAINE HYDROCHLORIDE .5; .5 g/100g; g/100g 24909-124_0c159510-f79a-4ef1-ac1e-33b5fe9a7d6c 24909-124 HUMAN OTC DRUG Terrasil Itch, Rash and Pain Relief MAX Allantoin, Lidocaine OINTMENT TOPICAL 20120907 OTC MONOGRAPH FINAL part347 Aidance Skincare & Topical Solutions, LLC ALLANTOIN; LIDOCAINE HYDROCHLORIDE 1; 1 g/100g; g/100g 24909-125_d9408f9d-0b80-43a3-8393-c20dfcf0522a 24909-125 HUMAN OTC DRUG Terrasil Foot and Nail Anti-Fungal Clotrimazole CREAM TOPICAL 20140626 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC CLOTRIMAZOLE 1 g/100g 24909-126_595dc585-e5bf-4131-9bcb-70a90a1544dc 24909-126 HUMAN OTC DRUG Terrasil Foot and Nail Anti-Fungal Maximum Strength Clotrimazole OINTMENT TOPICAL 20140627 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC CLOTRIMAZOLE 1 g/100g 24909-127_ff17bc66-f59e-43d3-b944-cbefc38b8da0 24909-127 HUMAN OTC DRUG Terrasil Wart Removal Thuja Occidentalis OINTMENT TOPICAL 20140228 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/g 24909-131_b95d54a2-dc26-4e93-bd59-5d0dbedb0e19 24909-131 HUMAN OTC DRUG Terrasil Skin Repair Allantoin, Benzethonium Chloride OINTMENT TOPICAL 20120907 OTC MONOGRAPH NOT FINAL part347 Aidance Skincare & Topical Solutions, LLC ALLANTOIN; BENZETHONIUM CHLORIDE .5; .1 g/100g; g/100g 24909-132_7abb8129-10f0-488b-992e-9ccd5a32f321 24909-132 HUMAN OTC DRUG Terrasil Skin Repair MAX Allantoin, Benzethonium Chloride OINTMENT TOPICAL 20120907 OTC MONOGRAPH NOT FINAL part347 Aidance Skincare & Topical Solutions, LLC ALLANTOIN; BENZETHONIUM CHLORIDE 1; .2 g/100g; g/100g 24909-134_0c03bb2f-83ff-4cbd-8e8c-8524c6228092 24909-134 HUMAN OTC DRUG Terrasil Psoriasis Therapy Maximum Strength Salicylic Acid OINTMENT TOPICAL 20121212 OTC MONOGRAPH FINAL part358H Aidance Skincare & Topical Solutions, LLC SALICYLIC ACID 3 g/100g 24909-140_9b454815-5a27-4929-ac19-0d842dce8cdd 24909-140 HUMAN OTC DRUG Terrasil Shingles Treatment Natrum Muriaticum, Ranunculus Bulbosus OINTMENT TOPICAL 20121011 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC RANUNCULUS BULBOSUS; SODIUM CHLORIDE 10; 6 [hp_X]/g; [hp_X]/g 24909-141_d3f92867-9f0d-40b9-905b-6ecfd2a24597 24909-141 HUMAN OTC DRUG Terrasil Shingles Treatment Maximum Strength Natrum Muriaticum, Ranunculus Bulbosus OINTMENT TOPICAL 20121011 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC RANUNCULUS BULBOSUS; SODIUM CHLORIDE 10; 3 [hp_X]/g; [hp_X]/g 24909-142_780bd6e0-addd-47a7-8cae-009e4ea4000b 24909-142 HUMAN OTC DRUG Terragen HG Treatment Graphites, Natrum Muriaticum, Ranunculus Bulbosus, Thuja Occidentalis OINTMENT TOPICAL 20121011 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC GRAPHITE; RANUNCULUS BULBOSUS; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 24909-143_7c369457-5abe-42af-bce4-061d74ab75e8 24909-143 HUMAN OTC DRUG Terragen HG Treatment Maximum Strength Graphites, Natrum Muriaticum, Ranunculus Bulbosus, Thuja Occidentalis OINTMENT TOPICAL 20121011 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC GRAPHITE; RANUNCULUS BULBOSUS; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 24909-144_66c06d4f-12ab-4ff7-9e6b-bfc0ca0b30d1 24909-144 HUMAN OTC DRUG Terrasil Molluscum Treatment Thuja Occidentalis OINTMENT TOPICAL 20121015 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/g 24909-145_20d7e5e9-8d88-483d-a7dd-b67e7f184459 24909-145 HUMAN OTC DRUG Terrasil Molluscum Treatment Maximum Strength Thuja Occidentalis OINTMENT TOPICAL 20121015 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC THUJA OCCIDENTALIS LEAFY TWIG 3 [hp_X]/g 24909-146_30e3d891-794e-491e-abb6-2cd0195edf39 24909-146 HUMAN OTC DRUG Terrasil IPL Relief Thuja Occidentalis OINTMENT TOPICAL 20140314 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/g 24909-147_a12e7d6a-24be-43d7-9804-b5e1b95f6edf 24909-147 HUMAN OTC DRUG Terrasil IPL Relief Maximum Strength Thuja Occidentalis OINTMENT TOPICAL 20140314 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC THUJA OCCIDENTALIS LEAFY TWIG 3 [hp_X]/g 24909-148_e0eccf39-59a5-4478-bd16-f453a06f3836 24909-148 HUMAN OTC DRUG Terrasil S.O.S. Formula Natrum Muriaticum, Ranunculus Bulbosus OINTMENT TOPICAL 20140513 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC RANUNCULUS BULBOSUS; SODIUM CHLORIDE 10; 6 [hp_X]/g; [hp_X]/g 24909-149_18f25691-ef1b-446b-8683-093e9fb19bd9 24909-149 HUMAN OTC DRUG Terrasil S.O.S. Formula Maximum Strength Natrum Muriaticum, Ranunculus Bulbosus OINTMENT TOPICAL 20140513 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC RANUNCULUS BULBOSUS; SODIUM CHLORIDE 10; 3 [hp_X]/g; [hp_X]/g 24909-161_b4680e3c-d356-47db-9d8f-c2d6bbbde8e8 24909-161 HUMAN OTC DRUG Terrasil Fast and Natural Wart Removal Thuja Occidentalis OINTMENT TOPICAL 20140310 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/g 24909-162_3e80a11e-1c5e-43d3-a1b6-94c163bf30d9 24909-162 HUMAN OTC DRUG Terrasil Rapid-Relief Vaginal Miconazole Nitrate KIT 20140418 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC 24909-163_22ac774a-b61a-4d9b-85f6-3c1e835cdb51 24909-163 HUMAN OTC DRUG Terrasil Itch, Rash and Pain Relief Allantoin, Lidocaine KIT 20140418 OTC MONOGRAPH NOT FINAL part347 Aidance Skincare & Topical Solutions, LLC 24909-164_4a83f102-02d8-49d2-9abb-734866e13d72 24909-164 HUMAN OTC DRUG Terrasil Rapid-Clear Psoriasis Salicylic Acid, Thuja, Sulfur KIT 20140418 OTC MONOGRAPH FINAL part358H Aidance Skincare & Topical Solutions, LLC 24909-165_9a69f530-dfef-4d2b-888f-5d645c62ae18 24909-165 HUMAN OTC DRUG Terrasil Rapid-Clear Anti-Fungal Clotrimazole KIT 20140418 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC 24909-201_e607c872-637a-40d6-89bf-95ba0b6e18db 24909-201 HUMAN OTC DRUG Femmesil Creme Maximum Strength Miconazole Nitrate CREAM TOPICAL 20120907 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC MICONAZOLE NITRATE 2 g/100g 24909-202_638a25cb-47b3-40a4-af76-fde15a518b4c 24909-202 HUMAN OTC DRUG Femmesil Maximum Strength Miconazole Nitrate OINTMENT TOPICAL 20120907 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC MICONAZOLE NITRATE 2 g/100g 24909-203_8d5df756-b433-4c0c-aab4-952681b3686d 24909-203 HUMAN OTC DRUG Femmesil Clotrimazole CREAM TOPICAL 20141130 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC CLOTRIMAZOLE 1 g/100g 24909-301_c47bc18c-aa68-4df2-8eeb-c9daa67f19e6 24909-301 HUMAN OTC DRUG Pedesil Maximum Strength Clotrimazole OINTMENT TOPICAL 20120907 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC CLOTRIMAZOLE 1 g/100g 24909-303_8370f4bb-1c1a-42f1-b6a5-7b495bb614ed 24909-303 HUMAN OTC DRUG Pedesil Clotrimazole CREAM TOPICAL 20120907 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC CLOTRIMAZOLE 1 g/100g 24909-401_57e1e412-9769-4ad9-a315-0064a0c9eedc 24909-401 HUMAN OTC DRUG ThatZit Acne Treatment Salicylic Acid LOTION TOPICAL 20120907 OTC MONOGRAPH FINAL part333D Aidance Skincare & Topical Solutions, LLC SALICYLIC ACID 1 g/100g 24909-402_3fed7bb8-5af3-485d-b755-a6576379d2ab 24909-402 HUMAN OTC DRUG ThatZit Acne Treatment MAX Salicylic Acid LOTION TOPICAL 20120907 OTC MONOGRAPH FINAL part333D Aidance Skincare & Topical Solutions, LLC SALICYLIC ACID 2 g/100g 24909-606_4c0f30d8-2d5d-4bde-ad2c-4aae4997f2c0 24909-606 HUMAN OTC DRUG Aspiera Anti-Fungal Clotrimazole OINTMENT TOPICAL 20120531 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC CLOTRIMAZOLE 1 g/100g 24909-617_8be668f5-9e77-475e-aacd-7a81eb2fa59b 24909-617 HUMAN OTC DRUG Aspiera Wound Care and Antiseptic Allantoin, Benzethonium Chloride OINTMENT TOPICAL 20120531 OTC MONOGRAPH NOT FINAL part347 Aidance Skincare & Topical Solutions, LLC ALLANTOIN; BENZETHONIUM CHLORIDE .5; .1 g/100g; g/100g 24909-618_e57a73f6-5be7-48bc-89b2-d982f5909ef6 24909-618 HUMAN OTC DRUG Aspiera Wound Care and Antiseptic Allantoin, Benzethonium Chloride OINTMENT TOPICAL 20120722 OTC MONOGRAPH NOT FINAL part347 Aidance Skincare & Topical Solutions, LLC ALLANTOIN; BENZETHONIUM CHLORIDE 1; .2 g/100g; g/100g 24913-2234_c10abd2b-6d2c-4793-a2ce-997419f960f8 24913-2234 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19840601 UNAPPROVED MEDICAL GAS DENISON INC OXYGEN 990 mL/L 24979-009_62ee0394-43a3-4b8b-b2fc-5f0cf9499903 24979-009 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 TWI Pharmaceuticals, Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 24979-010_62ee0394-43a3-4b8b-b2fc-5f0cf9499903 24979-010 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 TWI Pharmaceuticals, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 24979-011_62ee0394-43a3-4b8b-b2fc-5f0cf9499903 24979-011 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 TWI Pharmaceuticals, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 24979-514_07adab32-b55b-4f66-b216-bdf78541478a 24979-514 HUMAN PRESCRIPTION DRUG Divalproex Sodium Delayed-Release Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110601 ANDA ANDA078411 TWi Pharmaceuticals, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 24987-075_40362e20-dfbf-4367-aae4-49b6292c57d6 24987-075 HUMAN PRESCRIPTION DRUG Kayexalate sodium polystyrene sulfonate POWDER, FOR SUSPENSION ORAL; RECTAL 20130715 NDA NDA011287 Covis Pharmaceuticals, Inc. SODIUM POLYSTYRENE SULFONATE 4.1 meq/g 24987-087_812998b0-34e4-4c98-8e54-22a70ccc8d6b 24987-087 HUMAN PRESCRIPTION DRUG Dutoprol metoprolol succinate and hydrochlorothiazide TABLET ORAL 20140701 NDA NDA021956 Covis Pharmaceuticals Inc HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE 12.5; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 24987-095_812998b0-34e4-4c98-8e54-22a70ccc8d6b 24987-095 HUMAN PRESCRIPTION DRUG Dutoprol metoprolol succinate and hydrochlorothiazide TABLET ORAL 20140701 NDA NDA021956 Covis Pharmaceuticals Inc HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE 12.5; 50 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 24987-097_812998b0-34e4-4c98-8e54-22a70ccc8d6b 24987-097 HUMAN PRESCRIPTION DRUG Dutoprol metoprolol succinate and hydrochlorothiazide TABLET ORAL 20140701 NDA NDA021956 Covis Pharmaceuticals Inc HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE 12.5; 100 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 24987-111_42dc25a5-1b10-4e46-aaec-91b78d75da08 24987-111 HUMAN PRESCRIPTION DRUG Nilandron Nilutamide TABLET ORAL 20130715 NDA NDA020169 Covis Pharmaceuticals, Inc. NILUTAMIDE 150 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 24987-200_40c0d6c5-c590-40ff-96d6-7cd83b033f2e 24987-200 HUMAN PRESCRIPTION DRUG Uroxatral alfuzosin HCl TABLET, EXTENDED RELEASE ORAL 20130603 NDA NDA021287 Covis Pharmaceuticals Inc. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 24987-240_14d5d34e-5931-4f02-a561-8fe925950714 24987-240 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20120930 NDA NDA020405 Covis Pharmaceuticals, Inc. DIGOXIN .0625 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 24987-242_14d5d34e-5931-4f02-a561-8fe925950714 24987-242 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20120930 NDA NDA020405 Covis Pharmaceuticals, Inc. DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 24987-245_14d5d34e-5931-4f02-a561-8fe925950714 24987-245 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20120930 NDA NDA020405 Covis Pharmaceuticals, Inc. DIGOXIN .1875 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 24987-249_14d5d34e-5931-4f02-a561-8fe925950714 24987-249 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20120930 NDA NDA020405 Covis Pharmaceuticals, Inc. DIGOXIN .25 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 24987-260_90983c9a-5680-42cb-953f-bf15e9a7869b 24987-260 HUMAN PRESCRIPTION DRUG LANOXIN digoxin INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130215 NDA NDA009330 Covis Pharmaceuticals Inc DIGOXIN 250 ug/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 24987-262_90983c9a-5680-42cb-953f-bf15e9a7869b 24987-262 HUMAN PRESCRIPTION DRUG LANOXIN digoxin INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130114 NDA NDA009330 Covis Pharmaceuticals Inc DIGOXIN 100 ug/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 24987-352_08047229-a45e-4def-965d-72a258953cde 24987-352 HUMAN PRESCRIPTION DRUG ZINACEF cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130115 NDA NDA050558 Covis Pharmaceuticals Inc CEFUROXIME SODIUM 90 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 24987-354_08047229-a45e-4def-965d-72a258953cde 24987-354 HUMAN PRESCRIPTION DRUG ZINACEF cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130115 NDA NDA050558 Covis Pharmaceuticals Inc CEFUROXIME SODIUM 90 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 24987-362_82ff9ee1-b4a7-440d-9045-93551ec429e9 24987-362 HUMAN PRESCRIPTION DRUG ZANTAC ranitidine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130315 NDA NDA019090 Covis Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 25 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 24987-363_82ff9ee1-b4a7-440d-9045-93551ec429e9 24987-363 HUMAN PRESCRIPTION DRUG ZANTAC ranitidine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130614 NDA NDA019090 Covis Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 25 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 24987-364_f6e057d6-ec9a-45da-ba74-0ebda3fa873c 24987-364 HUMAN PRESCRIPTION DRUG ZANTAC ranitidine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130614 NDA NDA019090 Covis Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 25 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 24987-377_d6c614b3-dd2e-4abc-ad78-80c9b01ad9b2 24987-377 HUMAN PRESCRIPTION DRUG FORTAZ ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121214 NDA NDA050578 Covis Pharmaceuticals, Inc. CEFTAZIDIME 100 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 24987-378_d6c614b3-dd2e-4abc-ad78-80c9b01ad9b2 24987-378 HUMAN PRESCRIPTION DRUG FORTAZ ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121214 NDA NDA050578 Covis Pharmaceuticals, Inc. CEFTAZIDIME 100 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 24987-379_d6c614b3-dd2e-4abc-ad78-80c9b01ad9b2 24987-379 HUMAN PRESCRIPTION DRUG FORTAZ ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121214 NDA NDA050578 Covis Pharmaceuticals, Inc. CEFTAZIDIME 170 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 24987-382_d6c614b3-dd2e-4abc-ad78-80c9b01ad9b2 24987-382 HUMAN PRESCRIPTION DRUG FORTAZ ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121214 NDA NDA050578 Covis Pharmaceuticals, Inc. CEFTAZIDIME 200 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 24987-400_08047229-a45e-4def-965d-72a258953cde 24987-400 HUMAN PRESCRIPTION DRUG ZINACEF cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130115 NDA NDA050558 Covis Pharmaceuticals Inc CEFUROXIME SODIUM 90 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 24987-412_d6c614b3-dd2e-4abc-ad78-80c9b01ad9b2 24987-412 HUMAN PRESCRIPTION DRUG FORTAZ ceftazidime sodium INJECTION, SOLUTION INTRAVENOUS 20130415 NDA NDA050634 Covis Pharmaceuticals, Inc. CEFTAZIDIME 20 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 24987-413_d6c614b3-dd2e-4abc-ad78-80c9b01ad9b2 24987-413 HUMAN PRESCRIPTION DRUG FORTAZ ceftazidime sodium INJECTION, SOLUTION INTRAVENOUS 20130415 NDA NDA050634 Covis Pharmaceuticals, Inc. CEFTAZIDIME 40 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 24987-425_08047229-a45e-4def-965d-72a258953cde 24987-425 HUMAN PRESCRIPTION DRUG ZINACEF cefuroxime INJECTION, SOLUTION INTRAVENOUS 20121015 NDA NDA050643 Covis Pharmaceuticals Inc CEFUROXIME SODIUM 1.5 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 24987-434_d6c614b3-dd2e-4abc-ad78-80c9b01ad9b2 24987-434 HUMAN PRESCRIPTION DRUG FORTAZ ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121214 NDA NDA050578 Covis Pharmaceuticals, Inc. CEFTAZIDIME 56 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 24987-435_d6c614b3-dd2e-4abc-ad78-80c9b01ad9b2 24987-435 HUMAN PRESCRIPTION DRUG FORTAZ ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121214 NDA NDA050578 Covis Pharmaceuticals, Inc. CEFTAZIDIME 111 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 24987-436_08047229-a45e-4def-965d-72a258953cde 24987-436 HUMAN PRESCRIPTION DRUG ZINACEF cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130115 NDA NDA050558 Covis Pharmaceuticals Inc CEFUROXIME SODIUM 90 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 24987-437_08047229-a45e-4def-965d-72a258953cde 24987-437 HUMAN PRESCRIPTION DRUG ZINACEF cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130115 NDA NDA050558 Covis Pharmaceuticals Inc CEFUROXIME SODIUM 90 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 24987-447_9826af70-2d2b-46e4-b078-79ea42bf210a 24987-447 HUMAN PRESCRIPTION DRUG PARNATE tranylcypromine sulfate TABLET, FILM COATED ORAL 20130114 NDA NDA012342 Covis Pharmaceuticals Inc TRANYLCYPROMINE SULFATE 10 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] 24987-562_631ed616-f23c-43c9-b63b-f53707c077cb 24987-562 HUMAN PRESCRIPTION DRUG Plaquenil Hydroxychloroquine Sulfate TABLET ORAL 20130628 NDA NDA009768 Covis Pharmaceuticals Inc HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 24987-700_10c8d5e6-cb9f-402d-ab8e-65c1aa049e89 24987-700 HUMAN PRESCRIPTION DRUG Rilutek riluzole TABLET ORAL 20130715 NDA NDA020599 Covis Pharmaceuticals, Inc. RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] 25000-103_30c2b871-0fea-449c-bdb8-9d02d9afd8ea 25000-103 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20110228 ANDA ANDA090007 MARKSANS PHARMA LIMITED GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 25000-104_30c2b871-0fea-449c-bdb8-9d02d9afd8ea 25000-104 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20110228 ANDA ANDA090007 MARKSANS PHARMA LIMITED GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 25000-105_30c2b871-0fea-449c-bdb8-9d02d9afd8ea 25000-105 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20110228 ANDA ANDA090007 MARKSANS PHARMA LIMITED GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 25000-114_a48e2785-f99f-4185-a5ab-40b68e3874ee 25000-114 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110725 ANDA ANDA091239 Marksans Pharma Limited IBUPROFEN 200 mg/1 25000-115_7cb4f325-b9a8-4f42-b585-a51ac2d33dda 25000-115 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20120704 ANDA ANDA091237 MARKSANS PHARMA LIMITED IBUPROFEN 200 mg/1 25000-117_a48e2785-f99f-4185-a5ab-40b68e3874ee 25000-117 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110725 ANDA ANDA091239 Marksans Pharma Limited IBUPROFEN 200 mg/1 25000-120_7cb4f325-b9a8-4f42-b585-a51ac2d33dda 25000-120 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20120704 ANDA ANDA091237 MARKSANS PHARMA LIMITED IBUPROFEN 200 mg/1 25000-121_fc085133-f249-445b-98da-54f7493a8b25 25000-121 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110228 ANDA ANDA090796 MARKSANS PHARMA LIMITED IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 25000-122_fc085133-f249-445b-98da-54f7493a8b25 25000-122 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110228 ANDA ANDA090796 MARKSANS PHARMA LIMITED IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 25000-123_fc085133-f249-445b-98da-54f7493a8b25 25000-123 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110228 ANDA ANDA090796 MARKSANS PHARMA LIMITED IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 25000-131_a793960f-b521-4779-bf35-384d2753804f 25000-131 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20120601 ANDA ANDA090888 MARKSANS PHARMA LIMITED METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 25000-132_a793960f-b521-4779-bf35-384d2753804f 25000-132 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20120601 ANDA ANDA090888 MARKSANS PHARMA LIMITED METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 25000-133_467b71f9-1954-46bb-b94d-e46ed3b0c66e 25000-133 HUMAN OTC DRUG IBUPROFEN ibuprofen CAPSULE, LIQUID FILLED ORAL 20110509 ANDA ANDA079205 Marksans Pharma Limited IBUPROFEN 200 mg/1 25000-134_a793960f-b521-4779-bf35-384d2753804f 25000-134 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20120601 ANDA ANDA090888 MARKSANS PHARMA LIMITED METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 25000-138_7640856c-ed83-45d7-832d-621af4e64ff3 25000-138 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110228 ANDA ANDA091416 MARKSANS PHARMA LIMITED NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 25000-139_7640856c-ed83-45d7-832d-621af4e64ff3 25000-139 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110228 ANDA ANDA091416 MARKSANS PHARMA LIMITED NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 25000-140_7640856c-ed83-45d7-832d-621af4e64ff3 25000-140 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110228 ANDA ANDA091416 MARKSANS PHARMA LIMITED NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 25000-141_c6c885d8-833d-4945-a9f3-7134d49841e2 25000-141 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium, Coated Tablets TABLET ORAL 20110528 ANDA ANDA090545 Marksans Pharma Limited NAPROXEN SODIUM 220 mg/1 25000-144_c6c885d8-833d-4945-a9f3-7134d49841e2 25000-144 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium Tablet, coated TABLET ORAL 20110504 ANDA ANDA090545 Marksans Pharma Limited NAPROXEN SODIUM 220 mg/1 25010-210_d07c54fb-af1e-4cb9-83a7-8a191d5aea25 25010-210 HUMAN PRESCRIPTION DRUG Sodium Edecrin ethacrynate sodium POWDER, FOR SOLUTION INTRAVENOUS 19670110 NDA NDA016093 Aton Pharma, Inc. ETHACRYNATE SODIUM 50 mg/50mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 25010-215_a66cb5df-2c91-458c-af12-c1ba285198f0 25010-215 HUMAN PRESCRIPTION DRUG EDECRIN ethacrynic acid TABLET ORAL 19670110 NDA NDA016092 Aton Pharma, Inc. ETHACRYNIC ACID 25 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 25010-305_90965385-d7cf-4d26-8ed6-7c9b2558324d 25010-305 HUMAN PRESCRIPTION DRUG Demser metyrosine CAPSULE ORAL 19791003 NDA NDA017871 Aton Pharma, Inc. METYROSINE 250 mg/1 Catecholamine Synthesis Inhibitor [EPC],Catecholamine Synthesis Inhibitors [MoA] 25010-705_f65a25e2-f6eb-4830-83b6-bb98946b5a8d 25010-705 HUMAN PRESCRIPTION DRUG Cuprimine Penicillamine CAPSULE ORAL 19701204 NDA NDA019853 Aton Pharma, Inc. PENICILLAMINE 250 mg/1 Antirheumatic Agent [EPC] 25010-710_66ac38dc-4625-41ac-bc3f-9363b930c33d 25010-710 HUMAN PRESCRIPTION DRUG Syprine trientine hydrochloride CAPSULE ORAL 19851108 NDA NDA019194 Aton Pharma, Inc. TRIENTINE HYDROCHLORIDE 250 mg/1 Metal Chelating Activity [MoA],Metal Chelator [EPC] 25010-711_b3e18113-1156-4995-a7b6-0481b62cdcac 25010-711 HUMAN PRESCRIPTION DRUG Lodosyn carbidopa TABLET ORAL 20100413 NDA NDA017830 Aton Pharma, Inc CARBIDOPA 25 mg/1 25010-805_587d995e-963a-4990-9077-747490bfface 25010-805 HUMAN PRESCRIPTION DRUG Lacrisert hydroxypropyl cellulose PELLET OPHTHALMIC 19810601 NDA NDA018771 Aton Pharma, Inc. HYDROXYPROPYL CELLULOSE (TYPE H) 5 mg/1 Demulcent [EPC],Demulcent Activity [MoA] 25010-810_038144d4-407a-48ba-b434-a3906bcb949e 25010-810 HUMAN PRESCRIPTION DRUG Timoptic-XE Timolol Maleate SOLUTION OPHTHALMIC 19931114 NDA NDA020330 Aton Pharma, Inc. TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 25010-811_038144d4-407a-48ba-b434-a3906bcb949e 25010-811 HUMAN PRESCRIPTION DRUG Timoptic-XE Timolol Maleate SOLUTION OPHTHALMIC 19931114 NDA NDA020330 Aton Pharma, Inc. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 25010-812_2da4053f-96c8-4e40-ad53-c925447ce882 25010-812 HUMAN PRESCRIPTION DRUG Timoptic Timolol Maleate SOLUTION OPHTHALMIC 19780817 NDA NDA018086 Aton Pharma, Inc. TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 25010-813_2da4053f-96c8-4e40-ad53-c925447ce882 25010-813 HUMAN PRESCRIPTION DRUG Timoptic Timolol Maleate SOLUTION OPHTHALMIC 19780817 NDA NDA018086 Aton Pharma, Inc. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 25010-814_0f32f82b-4e6e-4958-9124-f97451ae3e20 25010-814 HUMAN PRESCRIPTION DRUG Timoptic Timolol Maleate SOLUTION OPHTHALMIC 19861105 NDA NDA019463 Aton Pharma, Inc. TIMOLOL MALEATE 2.5 mg/mL 25010-815_0f32f82b-4e6e-4958-9124-f97451ae3e20 25010-815 HUMAN PRESCRIPTION DRUG Timoptic Timolol Maleate SOLUTION OPHTHALMIC 19861105 NDA NDA019463 Aton Pharma, Inc. TIMOLOL MALEATE 5 mg/mL 25010-816_bb863817-8a54-49fc-beda-6cf8578cbb7c 25010-816 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION OPHTHALMIC 20091015 NDA NDA020330 Aton Pharma, Inc. TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 25010-817_bb863817-8a54-49fc-beda-6cf8578cbb7c 25010-817 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION OPHTHALMIC 19931114 NDA NDA020330 Aton Pharma, Inc. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 25021-100_51cfde2d-2f37-4fd9-acfd-83db990c902c 25021-100 HUMAN PRESCRIPTION DRUG cefazolin cefazolin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090201 ANDA ANDA063214 Sagent Pharmaceuticals CEFAZOLIN SODIUM 500 mg/2.2mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-101_51cfde2d-2f37-4fd9-acfd-83db990c902c 25021-101 HUMAN PRESCRIPTION DRUG cefazolin cefazolin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090201 ANDA ANDA063214 Sagent Pharmaceuticals CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-102_5af748a4-0ec1-46fd-8fea-3e4c949e5ad8 25021-102 HUMAN PRESCRIPTION DRUG Cefazolin cefazolin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20090401 ANDA ANDA063209 Sagent Pharmaceuticals CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-105_a7a700f4-7697-45c3-a749-2186ccbe97e8 25021-105 HUMAN PRESCRIPTION DRUG ceftriaxone ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091105 ANDA ANDA065329 Sagent Pharmaceuticals CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-106_a7a700f4-7697-45c3-a749-2186ccbe97e8 25021-106 HUMAN PRESCRIPTION DRUG ceftriaxone ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091105 ANDA ANDA065329 Sagent Pharmaceuticals CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-107_a7a700f4-7697-45c3-a749-2186ccbe97e8 25021-107 HUMAN PRESCRIPTION DRUG ceftriaxone ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091105 ANDA ANDA065329 Sagent Pharmaceuticals CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-108_4f17c088-7460-45eb-b014-0c29689e0ca7 25021-108 HUMAN PRESCRIPTION DRUG Ceftriaxone CEFTRIAXONE Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091105 ANDA ANDA065328 Sagent Pharmaceuticals CEFTRIAXONE SODIUM 10 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-109_f893ea8d-c0dd-46b9-98fc-7b7094fcc5f9 25021-109 HUMAN PRESCRIPTION DRUG Cefoxitin cefoxitin sodium POWDER INTRAVENOUS 20091105 ANDA ANDA065414 Sagent Pharmaceuticals CEFOXITIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-110_f893ea8d-c0dd-46b9-98fc-7b7094fcc5f9 25021-110 HUMAN PRESCRIPTION DRUG Cefoxitin cefoxitin sodium POWDER INTRAVENOUS 20091105 ANDA ANDA065414 Sagent Pharmaceuticals CEFOXITIN SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-111_adb10161-58ce-4cf0-8f0f-7023e141b65f 25021-111 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION INTRAVENOUS 20100812 ANDA ANDA065415 Sagent Pharmaceuticals CEFOXITIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-112_8dc6b8fa-35c3-4332-9272-87ca1cc696d1 25021-112 HUMAN PRESCRIPTION DRUG Azithromycin azithromycin monohydrate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090501 ANDA ANDA065506 Sagent Pharmaceuticals AZITHROMYCIN MONOHYDRATE 500 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 25021-113_28af1ac3-6e7e-44f6-a363-6fce38b68083 25021-113 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20090901 ANDA ANDA079104 Sagent Pharmaceuticals FLUCONAZOLE 200 mg/100mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 25021-114_18b110d4-4a94-4f5d-9bf5-9c2bc2e76ed4 25021-114 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin INJECTION INTRAVENOUS 20080324 ANDA ANDA078252 Sagent Pharmaceuticals CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 25021-115_8bfa7993-d3bd-43a8-9287-ccb1fa3e440c 25021-115 HUMAN PRESCRIPTION DRUG Clindamycin clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120515 ANDA ANDA090108 Sagent Pharmaceuticals CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 25021-115_c86008d3-e813-43ff-a19b-43d0d69e1fda 25021-115 HUMAN PRESCRIPTION DRUG Clindamycin Clindamycin Phosphate INJECTION, SOLUTION INTRAVENOUS 20120515 ANDA ANDA090109 Sagent Pharmaceuticals CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 25021-116_cc1f47d7-7e2d-433b-9b95-1d930c0e1da6 25021-116 HUMAN PRESCRIPTION DRUG Bacitracin bacitracin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20100810 ANDA ANDA090211 Sagent Pharmaceuticals BACITRACIN 50000 [iU]/10mL Decreased Cell Wall Synthesis & Repair [PE] 25021-117_f6257c03-40c2-42c9-a6cc-718db0549990 25021-117 HUMAN PRESCRIPTION DRUG Polymyxin B Polymyxin B Sulfate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 20110801 ANDA ANDA090110 Sagent Pharmaceuticals POLYMYXIN B SULFATE 500000 [iU]/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 25021-118_d4fc9b2f-a002-426c-8c50-636d1a600542 25021-118 HUMAN PRESCRIPTION DRUG Cefuroxime Sodium Cefuroxime Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080501 ANDA ANDA065048 Sagent Pharmaceuticals CEFUROXIME SODIUM 750 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-119_d4fc9b2f-a002-426c-8c50-636d1a600542 25021-119 HUMAN PRESCRIPTION DRUG Cefuroxime Sodium Cefuroxime Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080501 ANDA ANDA065048 Sagent Pharmaceuticals CEFUROXIME SODIUM 1.5 g/16mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-120_d9a7dfe9-6a64-44af-83a1-36693f57c6c0 25021-120 HUMAN PRESCRIPTION DRUG Cefuroxime cefuroxime sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080501 ANDA ANDA065046 Sagent Pharmaceuticals CEFUROXIME SODIUM 7.5 g/82.5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-121_a764e42d-c627-4df9-af64-41b7064c77e2 25021-121 HUMAN PRESCRIPTION DRUG Cefepime cefepime hydrochloride INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080501 ANDA ANDA065441 Sagent Pharmaceuticals CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-122_a764e42d-c627-4df9-af64-41b7064c77e2 25021-122 HUMAN PRESCRIPTION DRUG Cefepime cefepime hydrochloride INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080501 ANDA ANDA065441 Sagent Pharmaceuticals CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-127_1835b1d4-ead8-45e8-b9a5-2e8ff766528f 25021-127 HUMAN PRESCRIPTION DRUG Ceftazidime ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080515 ANDA ANDA062640 Sagent Pharmaceuticals CEFTAZIDIME 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-128_1835b1d4-ead8-45e8-b9a5-2e8ff766528f 25021-128 HUMAN PRESCRIPTION DRUG Ceftazidime ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080515 ANDA ANDA062640 Sagent Pharmaceuticals CEFTAZIDIME 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-129_a2f71348-aeb3-4640-bd3e-c4707fe9c3f1 25021-129 HUMAN PRESCRIPTION DRUG Ceftazidime ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080515 ANDA ANDA062640 Sagent Pharmaceuticals CEFTAZIDIME 6 g/30mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 25021-130_2acbb9c1-babb-4843-8190-8897aeca3e84 25021-130 HUMAN PRESCRIPTION DRUG Levofloxacin levofloxacin INJECTION, SOLUTION INTRAVENOUS 20120105 ANDA ANDA200560 Sagent Pharmaceuticals LEVOFLOXACIN 25 mg/mL 25021-132_4eff85f4-5a84-4da9-a07c-2c54b436f7e0 25021-132 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20110620 ANDA ANDA090343 Sagent Pharmaceuticals LEVOFLOXACIN 5 mg/mL 25021-132_d15b23ea-ed61-4a00-b089-866c9c000c5c 25021-132 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20130715 ANDA ANDA090343 Sagent Pharmaceuticals LEVOFLOXACIN 5 mg/mL 25021-134_99b9fecb-4215-430c-a069-40fea134b924 25021-134 HUMAN PRESCRIPTION DRUG ampicillin ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140701 ANDA ANDA090354 Sagent Pharmaceuticals AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 25021-135_99b9fecb-4215-430c-a069-40fea134b924 25021-135 HUMAN PRESCRIPTION DRUG ampicillin ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140701 ANDA ANDA090354 Sagent Pharmaceuticals AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 25021-136_99b9fecb-4215-430c-a069-40fea134b924 25021-136 HUMAN PRESCRIPTION DRUG ampicillin ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140701 ANDA ANDA090354 Sagent Pharmaceuticals AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 25021-137_99b9fecb-4215-430c-a069-40fea134b924 25021-137 HUMAN PRESCRIPTION DRUG ampicillin ampicillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140701 ANDA ANDA090354 Sagent Pharmaceuticals AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 25021-138_1869a3f7-3f12-466c-96e9-2a9eef7bad58 25021-138 HUMAN PRESCRIPTION DRUG ampicillin ampicillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100707 ANDA ANDA063142 Sagent Pharmaceuticals AMPICILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 25021-139_08a3725d-b1dc-4a1b-aadd-1c138a8878d5 25021-139 HUMAN PRESCRIPTION DRUG Nafcillin nafcillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121025 ANDA ANDA090582 Sagent Pharmaceuticals NAFCILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 25021-140_08a3725d-b1dc-4a1b-aadd-1c138a8878d5 25021-140 HUMAN PRESCRIPTION DRUG Nafcillin nafcillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121025 ANDA ANDA090582 Sagent Pharmaceuticals NAFCILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 25021-141_f0f4ad66-5c5c-4cc8-b490-43ec65de84c8 25021-141 HUMAN PRESCRIPTION DRUG Nafcillin nafcillin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121025 ANDA ANDA090580 Sagent Pharmaceuticals NAFCILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 25021-142_5b85ba61-c226-43be-9b11-461abe80fc51 25021-142 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam ampicillin and sulbactam INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100630 ANDA ANDA065406 Sagent Pharmaceuticals, Inc. AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 25021-143_5b85ba61-c226-43be-9b11-461abe80fc51 25021-143 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam ampicillin and sulbactam INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100630 ANDA ANDA065406 Sagent Pharmaceuticals, Inc. AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 25021-144_1b8ef695-5160-48fc-bcfd-aa2ceb4372de 25021-144 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam ampicillin and sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100812 ANDA ANDA065403 Sagent Pharmaceuticals, Inc. AMPICILLIN SODIUM; SULBACTAM SODIUM 100; 50 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 25021-146_2827cb4c-4a15-4856-8773-e58c48246b58 25021-146 HUMAN PRESCRIPTION DRUG Oxacillin oxacillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140615 ANDA ANDA091246 Sagent Pharmaceuticals OXACILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 25021-146_f6dcf0c3-6966-4ed9-97e4-468a1a4d7fe4 25021-146 HUMAN PRESCRIPTION DRUG Oxacillin oxacillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120601 ANDA ANDA091246 Sagent Pharmaceuticals OXACILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 25021-157_54cd7640-6600-495c-9d00-f2b0b02eae60 25021-157 HUMAN PRESCRIPTION DRUG Vancomycin vancomycin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120920 ANDA ANDA200837 Sagent Pharmaceuticals VANCOMYCIN HYDROCHLORIDE 5 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 25021-162_2827cb4c-4a15-4856-8773-e58c48246b58 25021-162 HUMAN PRESCRIPTION DRUG Oxacillin oxacillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140615 ANDA ANDA091246 Sagent Pharmaceuticals OXACILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 25021-162_f6dcf0c3-6966-4ed9-97e4-468a1a4d7fe4 25021-162 HUMAN PRESCRIPTION DRUG Oxacillin oxacillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120601 ANDA ANDA091246 Sagent Pharmaceuticals OXACILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 25021-163_3d3f847d-f129-440e-b9e3-a22a3c900dd8 25021-163 HUMAN PRESCRIPTION DRUG Oxacillin oxacillin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140615 ANDA ANDA091245 Sagent Pharmaceuticals OXACILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 25021-163_54f29499-4c29-43e0-ae50-471413ec2211 25021-163 HUMAN PRESCRIPTION DRUG Oxacillin oxacillin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120601 ANDA ANDA091245 Sagent Pharmaceuticals OXACILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 25021-164_dda4715a-3c11-4afa-aeba-d69c03a20452 25021-164 HUMAN PRESCRIPTION DRUG Piperacillin, Tazobactam Piperacillin Sodium, Tazobactam Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110616 ANDA ANDA065498 Sagent Pharmaceuticals PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 25021-165_dda4715a-3c11-4afa-aeba-d69c03a20452 25021-165 HUMAN PRESCRIPTION DRUG Piperacillin, Tazobactam Piperacillin Sodium, Tazobactam Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110616 ANDA ANDA065498 Sagent Pharmaceuticals PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 25021-166_dda4715a-3c11-4afa-aeba-d69c03a20452 25021-166 HUMAN PRESCRIPTION DRUG Piperacillin, Tazobactam Piperacillin Sodium, Tazobactam Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110616 ANDA ANDA065498 Sagent Pharmaceuticals PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 25021-201_0e18f182-942a-4675-8c14-ce24feed7a8b 25021-201 HUMAN PRESCRIPTION DRUG Mesna mesna INJECTION, SOLUTION INTRAVENOUS 20130430 ANDA ANDA090913 Sagent Pharmaceuticals MESNA 100 mg/mL Cytoprotective Agent [EPC] 25021-201_d8ced2dd-b829-4829-8480-9a2a3aa7b118 25021-201 HUMAN PRESCRIPTION DRUG Mesna mesna INJECTION, SOLUTION INTRAVENOUS 20101201 ANDA ANDA090913 Sagent Pharmaceuticals MESNA 100 mg/mL Cytoprotective Agent [EPC] 25021-201_fa4d68c9-ddd2-499e-a183-524d652865ca 25021-201 HUMAN PRESCRIPTION DRUG mesna mesna INJECTION, SOLUTION INTRAVENOUS 20130430 ANDA ANDA090913 Sagent Pharmaceuticals MESNA 100 mg/mL Cytoprotective Agent [EPC] 25021-202_23f4d3dd-3f6a-41f6-8dee-c480696284df 25021-202 HUMAN PRESCRIPTION DRUG Carboplatin carboplatin INJECTION, SOLUTION INTRAVENOUS 20131031 ANDA ANDA077096 Sagent Pharmaceuticals CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 25021-203_7d6eeb50-479c-4a97-ad5b-af833fa735b5 25021-203 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride epirubicin hydrochloride INJECTION INTRAVENOUS 20140831 ANDA ANDA065361 Sagent Pharmaceuticals EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 25021-204_753fafca-59aa-454d-979e-9f7feec3bc7a 25021-204 HUMAN PRESCRIPTION DRUG Vinorelbine Vinorelbine INJECTION, SOLUTION INTRAVENOUS 20140915 ANDA ANDA091106 Sagent Pharmaceuticals VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 25021-205_8b3b6f1b-481f-4747-9366-99a6da7c384f 25021-205 HUMAN PRESCRIPTION DRUG Fludarabine phosphate Fludarabine phosphate INJECTION INTRAVENOUS 20090201 ANDA ANDA078610 Sagent Pharmaceutical, Inc. FLUDARABINE PHOSPHATE 50 mg/2mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 25021-206_cb8783c7-432e-4615-a52b-b0769bb62e00 25021-206 HUMAN PRESCRIPTION DRUG Topotecan Hydrochloride topotecan hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20101128 ANDA ANDA091284 Sagent Pharmaceuticals TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 25021-207_5eb88342-1910-417a-8e60-5f7196355c3c 25021-207 HUMAN PRESCRIPTION DRUG doxorubicin hydrochloride doxorubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 20131031 ANDA ANDA091495 Sagent Pharmaceuticals DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 25021-208_6e49921e-761e-4e68-864c-c29961fd0d2a 25021-208 HUMAN PRESCRIPTION DRUG Gemcitabine gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA079160 Sagent Pharmaceuticals GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 25021-209_6e49921e-761e-4e68-864c-c29961fd0d2a 25021-209 HUMAN PRESCRIPTION DRUG Gemcitabine gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA079160 Sagent Pharmaceuticals GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 25021-211_f197356e-67c3-4fd3-b4d4-b90beafb6f0e 25021-211 HUMAN PRESCRIPTION DRUG oxaliplatin oxaliplatin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120809 ANDA ANDA078803 Sagent Pharmaceuticals OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 25021-212_f197356e-67c3-4fd3-b4d4-b90beafb6f0e 25021-212 HUMAN PRESCRIPTION DRUG oxaliplatin oxaliplatin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120809 ANDA ANDA078803 Sagent Pharmaceuticals OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 25021-213_3473cc55-601b-4925-8cf5-06f1835f9ede 25021-213 HUMAN PRESCRIPTION DRUG Paclitaxel paclitaxel INJECTION, SOLUTION INTRAVENOUS 20110927 ANDA ANDA090130 Sagent Pharmaceuticals PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 25021-214_7f3c6fb4-03fb-4b92-8566-64af6c2e4cc0 25021-214 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride irinotecan hydrochloride INJECTION, SOLUTION INTRAVENOUS 20120420 ANDA ANDA078589 Sagent Pharmaceuticals IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 25021-222_3fead05a-55de-421f-bed1-bc208c99beae 25021-222 HUMAN PRESCRIPTION DRUG docetaxel docetaxel SOLUTION INTRAVENOUS 20130701 ANDA ANDA203551 Sagent Pharmaceuticals DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 25021-230_cb2bc3e0-9c18-4fa5-a813-7ce5cebf2572 25021-230 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride irinotecan hydrochloride INJECTION, SOLUTION INTRAVENOUS 20140815 ANDA ANDA090675 Sagent Pharmaceuticals IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 25021-233_3c6d1bc0-1e21-43dd-844c-2957fb19c327 25021-233 HUMAN PRESCRIPTION DRUG oxaliplatin oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20140915 ANDA ANDA203869 Sagent Pharmaceuticals OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 25021-236_940eda27-ad75-4b68-9c80-a746fe3384f5 25021-236 HUMAN PRESCRIPTION DRUG topotecan topotecan INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20141215 ANDA ANDA022453 Sagent Pharmaceuticals TOPOTECAN HYDROCHLORIDE 1 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 25021-237_e2a4aec7-7ba5-4200-a1fe-77904e671ac8 25021-237 HUMAN PRESCRIPTION DRUG fludarabine phosphate fludarabine phosphate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141215 ANDA ANDA076349 Sagent Pharmaceuticals FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 25021-300_5cb25f03-2aee-4c66-9d7a-1a604bb1d14c 25021-300 HUMAN PRESCRIPTION DRUG Labetalol Labetalol Hydrochloride INJECTION INTRAVENOUS 20100217 ANDA ANDA079134 Sagent Pharmaceuticals LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 25021-301_fc3dd301-f22e-4932-9ed5-445f1b30a081 25021-301 HUMAN PRESCRIPTION DRUG adenosine adenosine INJECTION INTRAVENOUS 20140416 ANDA ANDA077283 Sagent Pharmaceuticals ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 25021-301_fed3de13-d526-4b9f-b87a-b47af12490bf 25021-301 HUMAN PRESCRIPTION DRUG Adenosine adenosine INJECTION INTRAVENOUS 20090901 ANDA ANDA078686 Sagent Pharmaceuticals ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 25021-302_e03b37ed-f14a-4ad0-804f-b21291247289 25021-302 HUMAN PRESCRIPTION DRUG amiodarone hydrochloride amiodarone hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130715 ANDA ANDA077161 Sagent Pharmaceuticals AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 25021-303_ad48fef6-4247-432b-8538-530c77b5e60f 25021-303 HUMAN PRESCRIPTION DRUG Metoprolol metoprolol tartrate INJECTION INTRAVENOUS 20100510 ANDA ANDA090317 Sagent Pharmaceuticals METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 25021-307_7c8f811f-3555-44c0-8c04-2cb32b7428c3 25021-307 HUMAN PRESCRIPTION DRUG Adenosine adenosine SOLUTION INTRAVENOUS 20140328 ANDA ANDA090212 Sagent Pharmaceuticals ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 25021-400_324da191-e0c8-45c3-8389-4ac1caf7001f 25021-400 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20140701 ANDA ANDA090808 Sagent Pharmaceticals HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 25021-400_5fdab320-ec17-4687-a581-c938b68a43db 25021-400 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20100706 ANDA ANDA090808 Sagent Pharmaceticals HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 25021-401_0f2b71dd-89e9-49f4-8626-1a9b99f43bf0 25021-401 HUMAN PRESCRIPTION DRUG Heparin Sodium heparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20100706 ANDA ANDA090810 Sagent Pharmaceticals HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 25021-402_324da191-e0c8-45c3-8389-4ac1caf7001f 25021-402 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20140701 ANDA ANDA090808 Sagent Pharmaceticals HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 25021-402_5fdab320-ec17-4687-a581-c938b68a43db 25021-402 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20100706 ANDA ANDA090808 Sagent Pharmaceticals HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 25021-403_5fdab320-ec17-4687-a581-c938b68a43db 25021-403 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20100706 ANDA ANDA090808 Sagent Pharmaceticals HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 25021-404_fddd1511-2326-4ae6-8818-a41c2e52c89b 25021-404 HUMAN PRESCRIPTION DRUG Heparin Sodium heparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20100706 ANDA ANDA090809 Sagent Pharmaceuticals HEPARIN SODIUM 20000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 25021-451_8af84a7a-a879-4f2e-a1fe-7922ad3c7c59 25021-451 HUMAN PRESCRIPTION DRUG Octreotide Acetate octreotide acetate INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20131215 ANDA ANDA090834 Sagent Pharmaceuticals OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 25021-452_8af84a7a-a879-4f2e-a1fe-7922ad3c7c59 25021-452 HUMAN PRESCRIPTION DRUG Octreotide Acetate octreotide acetate INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20131215 ANDA ANDA090834 Sagent Pharmaceuticals OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 25021-453_8af84a7a-a879-4f2e-a1fe-7922ad3c7c59 25021-453 HUMAN PRESCRIPTION DRUG Octreotide Acetate octreotide acetate INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20131215 ANDA ANDA090834 Sagent Pharmaceuticals OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 25021-454_8af84a7a-a879-4f2e-a1fe-7922ad3c7c59 25021-454 HUMAN PRESCRIPTION DRUG Octreotide Acetate octreotide acetate INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20131215 ANDA ANDA091041 Sagent Pharmaceuticals OCTREOTIDE ACETATE 200 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 25021-455_8af84a7a-a879-4f2e-a1fe-7922ad3c7c59 25021-455 HUMAN PRESCRIPTION DRUG Octreotide Acetate octreotide acetate INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20131215 ANDA ANDA091041 Sagent Pharmaceuticals OCTREOTIDE ACETATE 1000 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 25021-501_d9788853-72ba-44cd-a995-77f1f62c823e 25021-501 HUMAN PRESCRIPTION DRUG sodium bicarbonate sodium bicarbonate SOLUTION INTRAVENOUS 20121002 20150131 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Sagent Pharmaceuticals SODIUM BICARBONATE 84 mg/mL 25021-600_a7ca6c68-27d6-4be2-8850-3513160b5c38 25021-600 HUMAN PRESCRIPTION DRUG Flumazenil flumazenil INJECTION, SOLUTION INTRAVENOUS 20120915 ANDA ANDA090584 Sagent Pharmaceuticals FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 25021-601_b5d3e50c-a55e-49b7-8333-80aa15a181c8 25021-601 HUMAN PRESCRIPTION DRUG caffeine citrate caffeine citrate SOLUTION INTRAVENOUS 20120915 ANDA ANDA090827 Sagent Pharmaceuticals CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 25021-602_b5d3e50c-a55e-49b7-8333-80aa15a181c8 25021-602 HUMAN PRESCRIPTION DRUG caffeine citrate caffeine citrate SOLUTION ORAL 20120915 ANDA ANDA091102 Sagent Pharmaceuticals CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 25021-608_46bfb85c-cd95-4e8d-a195-59760e0720dd 25021-608 HUMAN PRESCRIPTION DRUG propofol propofol INJECTION, EMULSION INTRAVENOUS 20140701 ANDA ANDA075102 Sagent Pharmaceuticals PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 25021-651_fa0fec7b-94eb-4352-bd31-40c3a3e2dfd2 25021-651 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate orphenadrine citrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20111001 ANDA ANDA090585 Sagent Pharmaceuticals ORPHENADRINE CITRATE 30 mg/mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 25021-652_3ea57cba-ac27-4721-880d-79949a271bf6 25021-652 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride ropivacaine hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20140923 ANDA ANDA090318 Sagent Pharmaceuticals ROPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 25021-653_3ea57cba-ac27-4721-880d-79949a271bf6 25021-653 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride ropivacaine hydrochloride INJECTION, SOLUTION EPIDURAL 20140923 ANDA ANDA090318 Sagent Pharmaceuticals ROPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 25021-654_3ea57cba-ac27-4721-880d-79949a271bf6 25021-654 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride ropivacaine hydrochloride INJECTION, SOLUTION EPIDURAL; PERINEURAL 20140923 ANDA ANDA090318 Sagent Pharmaceuticals ROPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 25021-655_335fa6eb-4dcf-4801-9211-3f71b0a489e2 25021-655 HUMAN PRESCRIPTION DRUG Midazolam midazolam hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120319 ANDA ANDA090315 Sagent Pharmaceuticals MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 25021-656_335fa6eb-4dcf-4801-9211-3f71b0a489e2 25021-656 HUMAN PRESCRIPTION DRUG Midazolam midazolam hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120319 ANDA ANDA090315 Sagent Pharmaceuticals MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 25021-657_97234f4c-7033-4a5b-bf1c-6db579cd37bf 25021-657 HUMAN PRESCRIPTION DRUG Vecuronium vecuronium bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110801 ANDA ANDA078274 Sagent Pharmaceuticals VECURONIUM BROMIDE 10 mg/10mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 25021-658_97234f4c-7033-4a5b-bf1c-6db579cd37bf 25021-658 HUMAN PRESCRIPTION DRUG Vecuronium vecuronium bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110801 ANDA ANDA078274 Sagent Pharmaceuticals VECURONIUM BROMIDE 20 mg/20mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 25021-659_d18de065-1260-49a2-9eee-14585a6a2d9d 25021-659 HUMAN PRESCRIPTION DRUG Atracurium Besylate atracurium besylate INJECTION, SOLUTION INTRAVENOUS 20120501 ANDA ANDA091488 Sagent Pharmaceuticals ATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 25021-659_f33a0b8d-081c-40c5-86a5-e75244bf1da8 25021-659 HUMAN PRESCRIPTION DRUG Atracurium Besylate atracurium besylate INJECTION, SOLUTION INTRAVENOUS 20140901 ANDA ANDA091488 Sagent Pharmaceuticals ATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 25021-660_a8c41ec4-90f7-46fa-bcbb-836e67b54188 25021-660 HUMAN PRESCRIPTION DRUG Midazolam midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20120319 ANDA ANDA090316 Sagent Pharmaceuticals MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 25021-661_a8c41ec4-90f7-46fa-bcbb-836e67b54188 25021-661 HUMAN PRESCRIPTION DRUG Midazolam midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20120319 ANDA ANDA090316 Sagent Pharmaceuticals MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 25021-662_70fa4f61-a5ad-4b5f-bfc4-3a2578283179 25021-662 HUMAN PRESCRIPTION DRUG rocuronium bromide rocuronium bromide SOLUTION INTRAVENOUS 20111220 ANDA ANDA091458 Sagent Pharmaceuticals ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 25021-668_4ddffe75-aee0-470f-bc86-3f00528d3dd7 25021-668 HUMAN PRESCRIPTION DRUG Cisatracurium Besylate cisatracurium besylate INJECTION, SOLUTION INTRAVENOUS 20120927 ANDA ANDA201836 Sagent Pharmaceuticals CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 25021-669_4ddffe75-aee0-470f-bc86-3f00528d3dd7 25021-669 HUMAN PRESCRIPTION DRUG Cisatracurium Besylate cisatracurium besylate INJECTION, SOLUTION INTRAVENOUS 20120927 ANDA ANDA201836 Sagent Pharmaceuticals CISATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 25021-670_0be6af9f-6a28-43bb-9536-0c88aa673af6 25021-670 HUMAN PRESCRIPTION DRUG Cisatracurium Besylate cisatracurium besylate INJECTION, SOLUTION INTRAVENOUS 20120927 ANDA ANDA201851 Sagent Pharmaceuticals CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 25021-671_3ea57cba-ac27-4721-880d-79949a271bf6 25021-671 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride ropivacaine hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20140923 ANDA ANDA090318 Sagent Pharmaceuticals ROPIVACAINE HYDROCHLORIDE 2 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 25021-672_d18de065-1260-49a2-9eee-14585a6a2d9d 25021-672 HUMAN PRESCRIPTION DRUG Atracurium Besylate atracurium besylate INJECTION, SOLUTION INTRAVENOUS 20120501 ANDA ANDA091489 Sagent Pharmaceuticals ATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 25021-672_f33a0b8d-081c-40c5-86a5-e75244bf1da8 25021-672 HUMAN PRESCRIPTION DRUG Atracurium Besylate atracurium besylate INJECTION, SOLUTION INTRAVENOUS 20140901 ANDA ANDA091489 Sagent Pharmaceuticals ATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 25021-673_8c35a5dd-0f74-4eaa-89f5-1d77c7f21c0b 25021-673 HUMAN PRESCRIPTION DRUG glydo lidocaine hydrochloride JELLY TOPICAL 20140915 ANDA ANDA201094 Sagent Pharmaceuticals LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 25021-674_2e4fafc8-5e6f-401c-bf32-4a29c00b6e8d 25021-674 HUMAN PRESCRIPTION DRUG etomidate etomidate INJECTION, SOLUTION INTRAVENOUS 20120810 ANDA ANDA078289 Sagent Pharmaceuticals ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 25021-700_a2e831d6-a6db-44d0-94dc-dd53d34a3a70 25021-700 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140905 ANDA ANDA091065 Sagent Pharmaceuticals KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 25021-701_a2e831d6-a6db-44d0-94dc-dd53d34a3a70 25021-701 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140905 ANDA ANDA091065 Sagent Pharmaceuticals KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 25021-703_3a94f270-998c-483d-94a0-540c6297c1c5 25021-703 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate INJECTION SUBCUTANEOUS 20110101 ANDA ANDA090641 Sagent Pharmaceuticals SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 25021-703_56d2d18c-6ed8-41d0-81f9-02d75322fa3d 25021-703 HUMAN PRESCRIPTION DRUG Sumatriptan sumatriptan INJECTION SUBCUTANEOUS 20131018 ANDA ANDA090314 Sagent Pharmaceuticals SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 25021-777_2588e93d-43a8-4d31-90ba-77d065d62fc8 25021-777 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120830 ANDA ANDA079224 Sagent Pharmaceuticals ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 25021-778_5079cd1a-3d12-4527-a7da-40a32ed3349a 25021-778 HUMAN PRESCRIPTION DRUG granisetron hydrochloride granisetron hydrochloride INJECTION INTRAVENOUS 20130531 ANDA ANDA091136 Sagent Pharmaceuticals GRANISETRON HYDROCHLORIDE .1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 25021-778_cde490b2-ae00-4d27-96af-d1467dd65cd6 25021-778 HUMAN PRESCRIPTION DRUG granisetron hydrochloride granisetron hydrochloride INJECTION INTRAVENOUS 20101201 ANDA ANDA091136 Sagent Pharmaceuticals GRANISETRON HYDROCHLORIDE .1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 25021-779_cde490b2-ae00-4d27-96af-d1467dd65cd6 25021-779 HUMAN PRESCRIPTION DRUG granisetron hydrochloride granisetron hydrochloride INJECTION INTRAVENOUS 20101201 ANDA ANDA091136 Sagent Pharmaceuticals GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 25021-780_2f08d402-d43a-4cd4-bd2d-051179769e87 25021-780 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION, SOLUTION INTRAVENOUS 20131101 ANDA ANDA091627 Sagent Pharmaceuticals LEVETIRACETAM 500 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 25021-781_f3f64c80-b009-4fac-9403-a047e7f44246 25021-781 HUMAN PRESCRIPTION DRUG granisetron hydrochloride granisetron hydrochloride INJECTION, SOLUTION INTRAVENOUS 20101201 ANDA ANDA091137 Sagent Pharmaceuticals GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 25021-782_2588e93d-43a8-4d31-90ba-77d065d62fc8 25021-782 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120830 ANDA ANDA090648 Sagent Pharmaceuticals ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 25021-802_2019d00b-fbf5-46fb-baf1-312f6d86c425 25021-802 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION INTRAVENOUS 20100115 ANDA ANDA078373 Sagent Pharmaceuticals PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 25021-803_2019d00b-fbf5-46fb-baf1-312f6d86c425 25021-803 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION INTRAVENOUS 20100115 ANDA ANDA078373 Sagent Pharmaceuticals PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 25021-806_e6815ea7-7e55-4d47-8349-041f7ea1fc69 25021-806 HUMAN PRESCRIPTION DRUG Haloperidol Lactate haloperidol lactate INJECTION, SOLUTION INTRAMUSCULAR 20111024 ANDA ANDA091637 Sagent Pharmaceuticals HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] 25021-813_1b7e6c65-9fb1-4012-8845-41f4a88e95a5 25021-813 HUMAN PRESCRIPTION DRUG Leucovorin leucovorin calcium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131201 ANDA ANDA200753 Sagent Pharmaceuticals LEUCOVORIN CALCIUM 50 mg/5mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 25021-813_83178701-a416-4e0e-ae5e-d421b24bb19f 25021-813 HUMAN PRESCRIPTION DRUG Leucovorin leucovorin calcium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120915 ANDA ANDA200753 Sagent Pharmaceuticals LEUCOVORIN CALCIUM 50 mg/5mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 25021-814_1b7e6c65-9fb1-4012-8845-41f4a88e95a5 25021-814 HUMAN PRESCRIPTION DRUG Leucovorin leucovorin calcium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131201 ANDA ANDA200753 Sagent Pharmaceuticals LEUCOVORIN CALCIUM 100 mg/10mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 25021-814_83178701-a416-4e0e-ae5e-d421b24bb19f 25021-814 HUMAN PRESCRIPTION DRUG Leucovorin leucovorin calcium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120915 ANDA ANDA200753 Sagent Pharmaceuticals LEUCOVORIN CALCIUM 100 mg/10mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 25021-815_1b7e6c65-9fb1-4012-8845-41f4a88e95a5 25021-815 HUMAN PRESCRIPTION DRUG Leucovorin leucovorin calcium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131201 ANDA ANDA200753 Sagent Pharmaceuticals LEUCOVORIN CALCIUM 200 mg/20mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 25021-815_83178701-a416-4e0e-ae5e-d421b24bb19f 25021-815 HUMAN PRESCRIPTION DRUG Leucovorin leucovorin calcium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120915 ANDA ANDA200753 Sagent Pharmaceuticals LEUCOVORIN CALCIUM 200 mg/20mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 25021-816_1b7e6c65-9fb1-4012-8845-41f4a88e95a5 25021-816 HUMAN PRESCRIPTION DRUG Leucovorin leucovorin calcium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131201 ANDA ANDA200855 Sagent Pharmaceuticals LEUCOVORIN CALCIUM 350 mg/17.5mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 25021-816_83178701-a416-4e0e-ae5e-d421b24bb19f 25021-816 HUMAN PRESCRIPTION DRUG Leucovorin leucovorin calcium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120915 ANDA ANDA200855 Sagent Pharmaceuticals LEUCOVORIN CALCIUM 350 mg/17.5mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 25021-817_c4d1a6b3-d119-41ee-8c5f-a4db81ccd269 25021-817 HUMAN PRESCRIPTION DRUG Acetazolamide acetazolamide sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120615 ANDA ANDA200880 Sagent Pharmaceuticals ACETAZOLAMIDE SODIUM 500 mg/5mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 25021-823_e6815ea7-7e55-4d47-8349-041f7ea1fc69 25021-823 HUMAN PRESCRIPTION DRUG Haloperidol Lactate haloperidol lactate INJECTION, SOLUTION INTRAMUSCULAR 20111024 ANDA ANDA200742 Sagent Pharmaceuticals HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] 25021-824_5ba0c914-789b-4462-9feb-c255cc3a0670 25021-824 HUMAN PRESCRIPTION DRUG Topotecan Hydrochloride topotecan hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110627 ANDA ANDA090620 Sagent Pharmaceuticals TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 25021-825_19f8f41f-5a48-49c7-a88d-a9ecd9af384c 25021-825 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20111205 ANDA ANDA090343 Sagent Pharmaceuticals LEVOFLOXACIN 5 mg/mL 25021-826_bb54cbee-dc10-40b7-ac35-d86b6ced7b3d 25021-826 HUMAN PRESCRIPTION DRUG zoledronic acid zoledronic acid INJECTION, SOLUTION INTRAVENOUS 20130302 NDA NDA203231 Sagent Pharmaceuticals ZOLEDRONIC ACID .04 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 25021-827_063d1caa-cd3b-4cad-83f5-ae72cb3cd31f 25021-827 HUMAN PRESCRIPTION DRUG ibandronate sodium ibandronate sodium INJECTION, SOLUTION INTRAVENOUS 20140902 ANDA ANDA202235 Sagent Pharmaceuticals IBANDRONATE SODIUM 3 mg/3mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 25021-830_3393610e-f236-429d-8a55-e3d0335576b2 25021-830 HUMAN PRESCRIPTION DRUG zoledronic acid zoledronic acid INJECTION, SOLUTION INTRAVENOUS 20130302 ANDA ANDA202828 Sagent Pharmaceuticals ZOLEDRONIC ACID .05 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 25113-111_3a23c20b-b279-4a67-b718-acdcf8d4fca5 25113-111 HUMAN OTC DRUG Quiksan Triclosan SOLUTION TOPICAL 20140429 OTC MONOGRAPH NOT FINAL part333E The Dodge Company Inc TRICLOSAN .00025 g/g 25113-222_8c42e75e-3cf4-4ed8-9014-db0fee82a1f7 25113-222 HUMAN OTC DRUG Forest Fresh Triclosan SOAP TOPICAL 20140429 OTC MONOGRAPH NOT FINAL part333E The Dodge Company, Inc. TRICLOSAN .004 g/g 25113-333_4e11651e-8686-421d-8f58-4befdbb8a2f1 25113-333 HUMAN OTC DRUG Germasidol Triclosan SOAP TOPICAL 20140429 OTC MONOGRAPH NOT FINAL part333A The Dodge Company Inc. TRICLOSAN .0057 g/g 25208-002_a7b4b835-81ca-43d8-b637-a8c584fa3514 25208-002 HUMAN PRESCRIPTION DRUG AGGRASTAT TIROFIBAN INJECTION, SOLUTION INTRAVENOUS 19980514 NDA NDA020913 Medicure International Inc TIROFIBAN HYDROCHLORIDE 5 mg/100mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 25225-009_7dc80a3e-3a5a-484f-a99a-641900d8de38 25225-009 HUMAN OTC DRUG Frosted Berry Hand Sanitizer None Frosted Berry Hand Sanitizer LIQUID TOPICAL 20091020 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 g/100g 25225-010_7ba1230b-8ec2-4f23-9852-55080c87a82d 25225-010 HUMAN OTC DRUG Peppermint Hand Sanitizer None Peppermint Hand Sanitizer LIQUID TOPICAL 20091105 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 g/100g 25225-011_e58fc07d-5f3a-4956-8d9c-40e36bce36c5 25225-011 HUMAN OTC DRUG Winter Vanilla Hand Sanitizer None Winter Vanilla Hand Sanitizer LIQUID TOPICAL 20091110 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 g/100g 25225-012_d02476d9-de1a-4540-9152-1b81737ae58e 25225-012 HUMAN OTC DRUG Unscented Hand Sanitizer Alcohol LIQUID TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 g/100g 25225-013_6e50f16b-808a-40fb-9e32-cdcffaa594f3 25225-013 HUMAN OTC DRUG Citrus Hand Sanitizer Alcohol LIQUID TOPICAL 20100503 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 g/100g 25225-014_76aa7a03-7510-4442-8954-2ee156582a57 25225-014 HUMAN OTC DRUG Cranberry Hand Sanitizer Alcohol LIQUID TOPICAL 20100503 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 g/100g 25225-015_b27ce3d7-4792-4b36-91ef-10fcf4d162b1 25225-015 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20100505 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 g/100g 25225-016_ea062687-2ba6-401a-ab55-a29706669368 25225-016 HUMAN OTC DRUG Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20100503 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 1/1001 25225-017_ca4ff989-8ba7-4485-bbe2-b74ba1e5cf21 25225-017 HUMAN OTC DRUG Strawberry Champagne Hand Sanitizer Alcohol LIQUID TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 g/100g 25225-018_644e9c4e-e21a-4319-a1e7-072e856c0c0f 25225-018 HUMAN OTC DRUG Vanilla Fig Hand Sanitizer Alcohol LIQUID TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333E Unique Holding Group Inc ALCOHOL 62 g/100g 25225-019_623e5ae3-bae8-4739-8d82-d0c5e0f85c97 25225-019 HUMAN OTC DRUG Pomegranate Rose Hand Sanitizer Alcohol LIQUID TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333E Unique Holding Group Inc ALCOHOL 62 g/100g 25225-020_1bcbf68c-e744-4325-8a63-1ee08a6596f7 25225-020 HUMAN OTC DRUG Honeysuckle Ginger Hand Sanitizer Alcohol LIQUID TOPICAL 20101130 OTC MONOGRAPH NOT FINAL part333E Unique Holding Group Inc ALCOHOL 62 g/100g 25225-021_b608d672-4c53-444b-bbe3-f6e4753171be 25225-021 HUMAN OTC DRUG Sunkissed Honeydew Hand Sanitizer Alcohol LIQUID TOPICAL 20101113 OTC MONOGRAPH NOT FINAL part333E Unique Holding Group Inc ALCOHOL 62 g/100g 25225-022_147ae190-584a-4fb9-b7cf-f216b99752aa 25225-022 HUMAN OTC DRUG Coconut Vanilla Hand Sanitizer Alcohol LIQUID TOPICAL 20101113 OTC MONOGRAPH NOT FINAL part333E Unique Holding Group Inc ALCOHOL 62 g/100g 25225-023_24709e22-6de1-4e30-b4cc-8b8be9122b53 25225-023 HUMAN OTC DRUG Aqua Sunset Hand Sanitizer Alcohol LIQUID TOPICAL 20101113 OTC MONOGRAPH NOT FINAL part333E Unique Holding Group Inc ALCOHOL 62 g/100g 25237-0012_3bcbf845-a995-442d-9a6d-a660ee355538 25237-0012 HUMAN OTC DRUG InnerEffect Regulate Anti-Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part358 KPSS, Inc. PYRITHIONE ZINC 1.54 L/100L 25237-0013_fc95d767-5b73-40be-9638-e76b0358e594 25237-0013 HUMAN OTC DRUG DualSenses Scalp Regulation Anti-Dandruff Shampoo PYRITHIONE ZINC SHAMPOO TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part358 KPSS, Inc. PYRITHIONE ZINC 1.2 L/100L 25237-0014_733151e0-0e80-486d-b9a3-7a9550531569 25237-0014 HUMAN OTC DRUG KMS California Head Remedy Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20110330 OTC MONOGRAPH FINAL part358H KPSS Inc. PYRITHIONE ZINC 1.5 mL/100mL 25237-0515_f41ee57f-b8d5-4801-b8aa-11da4f07d304 25237-0515 HUMAN OTC DRUG Head Remedy Zinc Pyrithione SHAMPOO TOPICAL 20060101 OTC MONOGRAPH FINAL part358H KPSS Inc. PYRITHIONE ZINC 1.5 g/100g 25237-0516_c38bb28f-113e-48cb-8e52-509ccb9ecc09 25237-0516 HUMAN OTC DRUG Head Remedy Dandruff Conditioner PYRITHIONE ZINC EMULSION TOPICAL 20060101 OTC MONOGRAPH FINAL part358H KPSS, Inc. PYRITHIONE ZINC 1 g/100g 25237-0517_952fd946-e43f-4cea-b306-a5968d001bc4 25237-0517 HUMAN OTC DRUG Dual Senses Scalp Regulation AntiDandruff Shampoo Pyrithione Zinc SHAMPOO TOPICAL 20081028 OTC MONOGRAPH FINAL part358 KPSS Inc. PYRITHIONE ZINC 1.2 g/100g 25280-004_29235929-4425-4b14-b7e1-dcfef5181f86 25280-004 HUMAN OTC DRUG Loesch Anti-Itch Therapy Hydrocortisone LIQUID TOPICAL 20140626 OTC MONOGRAPH NOT FINAL part348 Loesch Laboratory Consultants, Inc. HYDROCORTISONE 5 mg/mL 25280-005_cb09aa93-a9c8-473a-8900-878c3b9f677d 25280-005 HUMAN OTC DRUG Loesch Original Kleer-Plex Antimicrobial Face and Body Wash Benzethonium Chloride GEL CUTANEOUS 20140324 OTC MONOGRAPH NOT FINAL part333E Loesch Laboratory Consultants, Inc. BENZETHONIUM CHLORIDE 2 mg/mL 25280-006_90e33d83-292f-4724-9336-930dc83eb924 25280-006 HUMAN OTC DRUG Loesch Hair Regrowth Formula Unscented Topical Solution Extra-Strength for Men Minoxidil SOLUTION TOPICAL 20140730 ANDA ANDA075598 Loesch Laboratory Consultants, Inc. MINOXIDIL 3 g/60mL 25280-007_c58c6688-e81b-412d-b648-fabd8290ea09 25280-007 HUMAN OTC DRUG Loesch Hair Regrowth Formula Unscented Topical Solution Regular-Strength for Men and Women Minoxidil SOLUTION TOPICAL 20140811 ANDA ANDA075357 Loesch Laboratory Consultants, Inc. MINOXIDIL 2 g/100mL 25336-5563_b5b673c6-bf0f-4b84-9605-6d3b5d80df0f 25336-5563 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19690101 UNAPPROVED MEDICAL GAS Buffalo Welding Corp OXYGEN 99 L/100L 25373-001_8b4f71ca-439a-7f80-f085-0275d1ec5ad2 25373-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19901119 UNAPPROVED MEDICAL GAS Linde Gas North America LLC OXYGEN 99 L/100L 25373-002_e7da72d4-92db-ae01-770d-450ea59f9fa9 25373-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19901127 UNAPPROVED MEDICAL GAS Linde Gas North America LLC NITROGEN 99 L/100L 25373-003_f5660b38-438c-2f0f-fae5-8dbc2c0ba26e 25373-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19901127 UNAPPROVED MEDICAL GAS Linde Gas North America LLC NITROUS OXIDE 99 L/100L 25373-004_0b64d495-c913-e4cc-e49c-5cbaa32aec07 25373-004 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19901128 UNAPPROVED MEDICAL GAS Linde Gas North America LLC CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 25373-006_1cff4fb9-eafe-11bd-14a1-b6c9e3634fb7 25373-006 HUMAN PRESCRIPTION DRUG Air, Compressed Nitrogen, Oxygen GAS RESPIRATORY (INHALATION) 19891108 NDA NDA205765 Linde Gas North America LLC OXYGEN 21 L/100L 25373-010_e5c3f8af-fae7-ef1d-b1b3-d0f328862a84 25373-010 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19901127 NDA NDA206826 Linde Gas North America LLC HELIUM 99 L/100L 25373-011_9b8c59bc-83e2-8ca6-1363-07757d787f7b 25373-011 HUMAN PRESCRIPTION DRUG COMPRESSED GAS, OXIDIZING, N.O.S. Oxygen, Carbon Dioxide GAS RESPIRATORY (INHALATION) 19980624 UNAPPROVED MEDICAL GAS Linde Gas North America LLC CARBON DIOXIDE; OXYGEN 5; 95 L/100L; L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 25373-012_cb07156a-b24c-2466-fbca-de06e354b3b7 25373-012 HUMAN PRESCRIPTION DRUG COMPRESSED GAS, N.O.S. Helium, Oxygen GAS RESPIRATORY (INHALATION) 19980624 UNAPPROVED MEDICAL GAS Linde Gas North America LLC HELIUM; OXYGEN 79; 21 L/100L; L/100L 25373-101_e9765854-aabc-296d-3ae4-f316f21a64c2 25373-101 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19860616 UNAPPROVED MEDICAL GAS Linde Gas North America LLC OXYGEN 99 L/100L 25373-102_53492ae5-385d-62c8-54e9-ea6af49c28ec 25373-102 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19860801 UNAPPROVED MEDICAL GAS Linde Gas North America LLC NITROGEN 99 L/100L 25373-103_d1fbe8f7-1ada-f4ef-4b8f-f6437c8ab21d 25373-103 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19860616 UNAPPROVED MEDICAL GAS Linde Gas North America LLC NITROUS OXIDE 99 L/100L 25373-104_6fd905a4-2557-f67f-7195-354428a973f4 25373-104 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19901127 UNAPPROVED MEDICAL GAS Linde Gas North America LLC CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 25373-703_de84b64c-7489-568e-4a61-1c66b4fbdd2e 25373-703 HUMAN PRESCRIPTION DRUG Nitrous Oxide Sedara Nitrous Oxide GAS RESPIRATORY (INHALATION) 20120618 UNAPPROVED MEDICAL GAS Linde Gas North America LLC NITROUS OXIDE 990 mL/L 25382-505_56b66e7b-97c6-4441-8723-9a77b133cf70 25382-505 HUMAN OTC DRUG Mysotrol No Rinse Antiseptic Hand Cleanser Ethyl Alcohol GEL TOPICAL 20061201 OTC MONOGRAPH NOT FINAL part333 Derma Sciences ALCOHOL 62 mL/100mL 25431-424_b3d23a29-6413-4fe0-96ec-858d15659aa2 25431-424 HUMAN PRESCRIPTION DRUG Indocyanine Green Indocyanine Green and Water KIT 20080101 ANDA ANDA088400 PULSION Medical Systems AG 25543-001_0f728cea-adcf-4551-83c5-3d9a135d806c 25543-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19870813 UNAPPROVED MEDICAL GAS Airgas East, Inc. OXYGEN 995 mL/L 25543-004_10690114-2bf9-4ef5-ad9c-c485b58f974c 25543-004 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19910122 UNAPPROVED MEDICAL GAS Airgas East, Inc. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 25543-005_ef46c79e-1c19-4904-a310-30c085c4b7fc 25543-005 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19910115 UNAPPROVED MEDICAL GAS Airgas East, Inc. AIR 1000 mL/L 25543-011_e310afbc-50fa-4883-921e-792b38c6c391 25543-011 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19980217 UNAPPROVED MEDICAL GAS Airgas East, Inc. HELIUM 999 mL/L 25543-012_1e8dfa9a-3cc1-4cbe-84c4-12ad149b2027 25543-012 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19910115 UNAPPROVED MEDICAL GAS Airgas East, Inc. NITROUS OXIDE 990 mL/L 25543-100_c3b78044-b414-436e-8f46-cc0f35466a24 25543-100 HUMAN PRESCRIPTION DRUG Oxygen, Refrigerated Liquid Oxygen, Refrigerated Liquid GAS RESPIRATORY (INHALATION) 20100416 UNAPPROVED MEDICAL GAS AirGas East OXYGEN 1 L/L 25543-200_5155ec69-d6e8-411e-a385-c6e0c69775bd 25543-200 HUMAN PRESCRIPTION DRUG Tri-Med Medical Compressed Oxygen GAS RESPIRATORY (INHALATION) 20100422 UNAPPROVED MEDICAL GAS AirGas East OXYGEN 1 L/L 25682-001_f2a0e2df-28fa-47a3-b948-5c736d3d51e4 25682-001 HUMAN PRESCRIPTION DRUG Soliris eculizumab INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20070402 BLA BLA125166 Alexion Pharmaceuticals Inc. ECULIZUMAB 300 mg/30mL Complement Inhibitor [EPC],Complement Inhibitors [MoA] 26050-101_4ae70620-7b4a-4641-96e6-1078f1d5f882 26050-101 HUMAN OTC DRUG Anti Acne Natural Volcanic Sulfur SULFUR SOAP TOPICAL 20121001 OTC MONOGRAPH FINAL part333D Galenium Pharmasia Laboratories, PT SULFUR 10 g/100g 26050-101_ec6ddff2-07c6-4d22-b4c9-d0a41791e2fe 26050-101 HUMAN OTC DRUG Anti Acne Natural Volcanic Sulfur SULFUR SOAP TOPICAL 20121001 OTC MONOGRAPH FINAL part333D Galenium Pharmasia Laboratories, PT SULFUR 10 g/100g 26050-112_9220a5df-895d-4012-9b2d-d5f21673f327 26050-112 HUMAN OTC DRUG Joesoef Skincare Anti Acne Sulfur LOTION TOPICAL 20061001 OTC MONOGRAPH FINAL part333D PT Galenium Pharmasia Laboratories SULFUR 6.3 1/95mL 26052-017_fe5af802-5290-442f-a715-7b8c54fa2e38 26052-017 HUMAN OTC DRUG Natural Acne Solutions Clarifying Toner salicylic acid LIQUID TOPICAL 20100601 OTC MONOGRAPH FINAL part333 Burt's Bees, Inc. SALICYLIC ACID 1 mL/100mL 26482-0001_82f8c83e-c34f-4198-a96f-11d7520712d7 26482-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20061115 UNAPPROVED MEDICAL GAS Corner Medical OXYGEN 99 L/100L 26509-0001_5052401d-f817-4161-842e-66499734df34 26509-0001 HUMAN OTC DRUG Clorox CareConcepts Rash Relief zinc oxide OINTMENT TOPICAL 20140505 OTC MONOGRAPH FINAL part347 The Clorox Company PETROLATUM; ZINC OXIDE 67; 13 mg/100mL; mg/100mL 26509-0002_3e1a335c-8dc7-4922-9b68-ea2c715b69e4 26509-0002 HUMAN OTC DRUG Clorox Care Concepts Hand Sanitizer alcohol SOLUTION TOPICAL 20140407 OTC MONOGRAPH NOT FINAL part333A The Clorox Company ALCOHOL 67 mL/100mL 26509-0003_07d658ef-7632-4b98-e054-00144ff8d46c 26509-0003 HUMAN OTC DRUG Clorox Care Concepts Antimicrobial benzalkonium chloride SOAP TOPICAL 20140407 OTC MONOGRAPH NOT FINAL part333A The Clorox Company BENZALKONIUM CHLORIDE .12 g/100mL 26509-0004_98b2e92b-18b9-4e15-ac4e-8bcf2decaaa6 26509-0004 HUMAN OTC DRUG Clorox CareConcepts Perineal Cleansing Benzalkonium Chloride 0.13% SOLUTION TOPICAL 20140505 OTC MONOGRAPH NOT FINAL part333A The Clorox Company BENZALKONIUM CHLORIDE .13 mg/100mL 26509-0005_51f2952a-c613-4359-a61b-2be986d33888 26509-0005 HUMAN OTC DRUG Clorox Care Concepts KIT 20140407 EXEMPT DEVICE ABC The Clorox Company 26509-0007_e0042788-39e0-4817-a263-e48c84700d01 26509-0007 HUMAN OTC DRUG Clorox CareConcepts Bed Bath and Hygiene KIT 20140407 EXEMPT DEVICE ABC The Clorox Company 26509-0009_343098e5-f1fb-4f52-8dc1-bd1201971f94 26509-0009 HUMAN OTC DRUG Clorox CareConcepts Aloe Moisturizing dimethicone LOTION TOPICAL 20140407 OTC MONOGRAPH FINAL part347 The Clorox Company DIMETHICONE 1.25 mg/100mL 26550-001_8bbae9fd-f872-4113-9008-7657d7fe3a4e 26550-001 HUMAN OTC DRUG X3 Clean Hand Sanitizer Foam AEROSOL, FOAM TOPICAL 20090901 OTC MONOGRAPH FINAL part333 X3 Labs Inc. BENZALKONIUM CHLORIDE 1.3 uL/mL 26550-001_e3c9449c-64c1-4964-a1ec-2636c0aeb29c 26550-001 HUMAN OTC DRUG X3 Clean Hand Sanitizer Spray SPRAY TOPICAL 20090901 OTC MONOGRAPH FINAL part333 X3 Labs Inc. BENZALKONIUM CHLORIDE 1.3 uL/mL 26637-221_36eab3a0-6ffe-4d4c-9462-ae8f377a54c3 26637-221 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19940930 ANDA ANDA064076 Putney Inc AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 26637-222_36eab3a0-6ffe-4d4c-9462-ae8f377a54c3 26637-222 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19940930 ANDA ANDA064076 Putney Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 26637-321_54acadbe-b9e0-47d4-83c2-35c37c9c6ef7 26637-321 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Putney Inc AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 26637-322_54acadbe-b9e0-47d4-83c2-35c37c9c6ef7 26637-322 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Putney Inc AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 26637-323_54acadbe-b9e0-47d4-83c2-35c37c9c6ef7 26637-323 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Putney Inc AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 26637-711_93444621-5f55-4b90-a427-ef2cc82136ef 26637-711 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil TABLET, FILM COATED ORAL 20080528 ANDA ANDA065462 Putney Inc CEFPODOXIME PROXETIL 100 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 26637-712_93444621-5f55-4b90-a427-ef2cc82136ef 26637-712 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil TABLET, FILM COATED ORAL 20080528 ANDA ANDA065462 Putney Inc CEFPODOXIME PROXETIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 26866-001_18438c1a-c5da-4b77-b121-9a0fbca4c63a 26866-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130731 UNAPPROVED MEDICAL GAS Bandy's Pharmacy Inc OXYGEN 99 L/100L 27017-054_cfdfec1c-cb1b-42ec-8233-c65ade9025ca 27017-054 HUMAN OTC DRUG Spry Xylitol Cinnamon Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120201 OTC MONOGRAPH FINAL part355 Xlear Inc. SODIUM FLUORIDE .28 g/113g 27190-100_109cde2d-ec1f-43e7-a3d9-1402d1086673 27190-100 HUMAN PRESCRIPTION DRUG OXYGEN, REFRIGERATED LIQUID OXYGEN GAS RESPIRATORY (INHALATION) 20100218 UNAPPROVED MEDICAL GAS Home Respiratory Services, Inc. OXYGEN 1 L/L 27241-001_d54b30a6-9b1c-427d-857e-9ad8571c2b1e 27241-001 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20141230 ANDA ANDA201003 Ajanta Pharma Limited RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 27241-002_d54b30a6-9b1c-427d-857e-9ad8571c2b1e 27241-002 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20141230 ANDA ANDA201003 Ajanta Pharma Limited RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 27241-003_d54b30a6-9b1c-427d-857e-9ad8571c2b1e 27241-003 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20141230 ANDA ANDA201003 Ajanta Pharma Limited RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 27241-004_d54b30a6-9b1c-427d-857e-9ad8571c2b1e 27241-004 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20141230 ANDA ANDA201003 Ajanta Pharma Limited RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 27241-005_d54b30a6-9b1c-427d-857e-9ad8571c2b1e 27241-005 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20141230 ANDA ANDA201003 Ajanta Pharma Limited RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 27241-006_d54b30a6-9b1c-427d-857e-9ad8571c2b1e 27241-006 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20141230 ANDA ANDA201003 Ajanta Pharma Limited RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 27281-001_56434350-d8b9-4b08-b767-67818f9939bf 27281-001 HUMAN OTC DRUG Brain Power Semecarpus Anacardium Juice, Arnica Montana, Calcium Fluoride, Silybum Marianum Seed, Chincona Officinalis Bark, Herring Sperm DNA, Ginkgo, Egg Phospholipids, Achillea Millefolium, Phosphoric Acid, Saccharomyces Cerevisia RNA, Silicon Dioxide, and Zinc Sulphate Heptahydrate SPRAY ORAL 20131118 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC ACHILLEA MILLEFOLIUM; ARNICA MONTANA; CALCIUM FLUORIDE; CINCHONA OFFICINALIS BARK; EGG PHOSPHOLIPIDS; GINKGO; HERRING SPERM DNA; PHOSPHORIC ACID; SACCHAROMYCES CEREVISIAE RNA; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SILYBUM MARIANUM SEED OIL; ZINC SULFATE HEPTAHYDRATE 1.5; 1.5; 30; 3; 6; 3; 3; 30; 6; 30; 6; 1.5; 6 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL 27281-002_7f5efd40-6f63-46c3-bc14-38b2495ff732 27281-002 HUMAN OTC DRUG Livergen Arnica Montana, Byronia Alba Root, Silybum Marianum Seed, Chelidonium Majus, Herring Sperm DNA, Pork Liver, Cervus Elaphus Horn Oil, Sus Scrofa Pancreas, and Taraxacum Officinale SPRAY ORAL 20131113 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC ARNICA MONTANA; BRYONIA ALBA ROOT; CERVUS ELAPHUS HORN OIL; CHELIDONIUM MAJUS; HERRING SPERM DNA; PORK LIVER; SILYBUM MARIANUM SEED OIL; SUS SCROFA PANCREAS; TARAXACUM OFFICINALE 1.5; 200; 4; 200; 3; 3; .5; 4; 1 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL 27281-003_bb63362e-ee24-41eb-b12f-94b539d037fb 27281-003 HUMAN OTC DRUG Vivacity Alfalfa, Aralia Quinquefolia, Arnica Montana, Avena Sativa, DNA, Galium Aparine, Hypericum Perforatum, Oleum Animale, Pituitarium Posterium, Rhus Toxicodendron, RNA, Thuja Occidentalis, Alcohol, Glycerin, Water SPRAY ORAL 20131113 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC ALFALFA; AMERICAN GINSENG; ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; CERVUS ELAPHUS HORN OIL; GALIUM APARINE; HERRING SPERM DNA; HYPERICUM PERFORATUM; SACCHAROMYCES CEREVISIAE RNA; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 1; 1; 1.5; 1; 3; 1.5; 3; 200; 3; 4; 30; 200 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL 27281-004_9990ab02-44b3-4178-9626-78991a4a4c86 27281-004 HUMAN OTC DRUG Immune Booster Apis Mellifera, Baptisia Tinctoria, Silybum Marianum Seed, Herring Sperm DNA, Echinacea, Galium Aparine, Mercuric Chloride, Mercuric Sulfide, Nitric Acid, Sulfur Iodide, and Thuja Occidentalis Leafy Twig SPRAY ORAL 20131113 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC APIS MELLIFERA; BAPTISIA TINCTORIA; ECHINACEA, UNSPECIFIED; GALIUM APARINE; HERRING SPERM DNA; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; SILYBUM MARIANUM SEED OIL; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG 200; 3; 3; 1.5; 3; 200; 30; 30; 1.5; 200; 200 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL 27281-007_fae27ff5-6400-440f-80b1-2dc419554f45 27281-007 HUMAN OTC DRUG Diabetigen Arnica Montana, Arsenic Trioxide, Herring Sperm NDA, Echinacea, Unspecified, Hamamelis Virginiana Leaf, Chamaelirium Luteum Root, Pork Liver, Iris Versicolor Root, Sus Scrofa Pancreas, Phosphoric Acid, Rosmarinus Officinalis Flowering Top, Claviceps Purpurea Sclerotium, Syzygium Cumini Seed, and Uranyl Nitrate Hexahydrate SPRAY ORAL 20131209 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC ARNICA MONTANA; ARSENIC TRIOXIDE; CHAMAELIRIUM LUTEUM ROOT; CLAVICEPS PURPUREA SCLEROTIUM; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA LEAF; HERRING SPERM DNA; IRIS VERSICOLOR ROOT; PHOSPHORIC ACID; PORK LIVER; ROSMARINUS OFFICINALIS FLOWERING TOP; SUS SCROFA PANCREAS; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 1.5; 200; 1.5; 30; 1.5; 1.5; 3; 3; 200; 3; 1.5; 3; 1.5; 30 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL 27281-008_d9eb64ba-73ce-4440-9bb8-c2393b77640c 27281-008 HUMAN OTC DRUG Heartery American Ginseng, Arnica Montana, Gold, Barium Carbonate, Atropa Belladonna, Calcium Fluoride, Cholesterol, Herring Sperm DNA, Ginkgo, Saccharomyces Cerevisia RNA, Visbum Album Fruiting Top, and Ginger SPRAY ORAL 20131209 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC AMERICAN GINSENG; ARNICA MONTANA; ATROPA BELLADONNA; BARIUM CARBONATE; CALCIUM FLUORIDE; CHOLESTEROL; GINGER; GINKGO; GOLD; HERRING SPERM DNA; SACCHAROMYCES CEREVISIAE RNA; VISCUM ALBUM FRUITING TOP 1; 1.5; 3; 30; 6; 15; 30; 3; 30; 3; 3; 1.5 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL 27281-009_05bde5a5-d4c6-4783-860e-95afbbd19ca8 27281-009 HUMAN OTC DRUG Female Energy Chaste Tree, Arnica Montana, Caulophyllum Thalictroides Root, Cinchona Officinalis Bark, Turnera Diffusa Leafy Twig, Herring Sperm DNA, Lactuca Virosa, Onosmodium Virginianum Whole, Sus Scrofa Ovary, Phosphoric Acid, Sus Scrofa Pituitary Gland, Sepia Officinalis Juice, Thuja Occidentalis Leafy Twig SPRAY ORAL 20140807 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC ARNICA MONTANA; CAULOPHYLLUM THALICTROIDES ROOT; CHASTE TREE; CINCHONA OFFICINALIS BARK; HERRING SPERM DNA; LACTUCA VIROSA; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; TURNERA DIFFUSA LEAFY TWIG 1.5; 3; 1.5; 1.5; 3; 1.5; 30; 200; 30; 30; 6; 30; .5 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg 27281-010_f7d294c4-23f8-488a-b795-d65ec1391cd7 27281-010 HUMAN OTC DRUG Male Tonicity american ginseng, arnica montana, turnera diffusa leafy twig, herring sperm DNA, galium aparine, hamamelis virginiana root bark/stem bark, pork liver, cervus elaphus horn oil, ovis aries testicle, phosphoric acid, sus scrofa pituitary gland, thuja occidentalis leafy twig, thyroid, unspecified, tribulus terrestris, ginger SPRAY ORAL 20140808 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC AMERICAN GINSENG; ARNICA MONTANA; CERVUS ELAPHUS HORN OIL; GALIUM APARINE; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HERRING SPERM DNA; OVIS ARIES TESTICLE; PHOSPHORIC ACID; PORK LIVER; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRIBULUS TERRESTRIS; TURNERA DIFFUSA LEAFY TWIG 1.5; 1.5; 4; 1.5; 1.5; 1.5; 3; 3; 200; 3; 4; 1.5; 6; 1; 1 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg 27281-011_08a08c96-5fe1-4414-8c60-a839f8762639 27281-011 HUMAN OTC DRUG Lung Detox silver nitrate, arsenic trioxide, activated charcoal, silybum marianum seed, herring sperm DNA, pork liver, mercuric chloride, lead SPRAY ORAL 20140808 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; HERRING SPERM DNA; LEAD; MERCURIC CHLORIDE; PORK LIVER; SILVER NITRATE; SILYBUM MARIANUM SEED 200; 200; 3; 200; 200; 3; 200; .5 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg 27293-012_6e9a3eb8-fa5b-4c54-a0c0-24fe205b4e23 27293-012 HUMAN OTC DRUG Oral Gel Maximum Strength Benzocaine GEL TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part356 Budpak Inc. BENZOCAINE 20 g/100g 27293-013_19366a07-9784-4435-b83b-4882399e3f7b 27293-013 HUMAN OTC DRUG Baby Teething Oral Pain Reliever Benzocaine GEL TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part356 Budpak Inc. BENZOCAINE 7.5 g/100g 27293-014_1feefbdd-7a58-4862-a59b-a3263051e67d 27293-014 HUMAN OTC DRUG Triple Antibiotic Maximum Strength Bacitracin Zinc Neomycin Polymyxin B Sulfate OINTMENT TOPICAL 20110819 OTC MONOGRAPH FINAL part333B Budpak Inc. BACITRACIN ZINC; NEOMYCIN; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 27293-015_b9acba3e-b0e4-483c-b273-e05c674499e9 27293-015 HUMAN OTC DRUG Budpak Baby Teething Oral Pain Reliever Benzocaine GEL TOPICAL 20131226 OTC MONOGRAPH NOT FINAL part356 Budpak Inc. BENZOCAINE 7.5 g/100g 27293-016_7f9aefd9-47cf-49cf-a1b2-b6a2b60695ea 27293-016 HUMAN OTC DRUG Budpak First Aid Lidocaine HCL and Phenol CREAM TOPICAL 20130612 OTC MONOGRAPH NOT FINAL part348 Budpak Inc. LIDOCAINE HYDROCHLORIDE; PHENOL .005; .005 g/g; g/g 27293-017_1d91f27f-8cf0-4af1-a049-c74835d6859b 27293-017 HUMAN OTC DRUG BudPak Anti-Itch Hydrocortisone CREAM TOPICAL 20121217 OTC MONOGRAPH NOT FINAL part348 Budpak Inc. HYDROCORTISONE .01 g/g 27293-018_a7f5887e-da34-4842-a601-9aa8e9a398af 27293-018 HUMAN OTC DRUG Budpak Muscle Rub Menthol GEL TOPICAL 20121217 OTC MONOGRAPH FINAL part348 Budpak Inc. MENTHOL .025 g/g 27293-019_91a75546-e237-4970-a30c-6af048b0b011 27293-019 HUMAN OTC DRUG Budpak Oral Maximum Strength Benzocaine GEL TOPICAL 20130610 OTC MONOGRAPH NOT FINAL part356 Budpak Inc. BENZOCAINE .2 g/g 27293-020_71d5322a-77bd-4bbb-a7be-0a4eb5f84756 27293-020 HUMAN OTC DRUG Budpack Feminine Anti-itch Benzocaine Benzalkonium chloride CREAM TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part348 Budpak Inc. BENZALKONIUM CHLORIDE; BENZOCAINE 130; 5 mg/100g; g/100g 27293-022_2723f378-f50f-4606-b0b4-d6b33b7eddf2 27293-022 HUMAN OTC DRUG Budpak Feminine Anti-Itch Benzocaine and Resorcinol CREAM TOPICAL 20130610 OTC MONOGRAPH NOT FINAL part348 Budpak Inc. BENZOCAINE; RESORCINOL .05; .02 g/g; g/g 27293-023_37440f2f-0bc8-4799-8a1e-514b8d86a388 27293-023 HUMAN OTC DRUG Budpak Antifungal Miconazole Nitrate Miconazole Nitrate CREAM TOPICAL 20131129 OTC MONOGRAPH FINAL part333C Budpak Inc. MICONAZOLE NITRATE .02 g/g 27293-024_668371ff-a1b5-4818-896f-425890f542e3 27293-024 HUMAN OTC DRUG Budpak Triple Antibiotic Maximum Strength Bacitracin Zinc, Neomycin Sulfate and Polymyxin B Sulfate OINTMENT TOPICAL 20130610 OTC MONOGRAPH FINAL part333B Budpak Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 27293-025_4917ddf3-ebec-4149-b6d7-9fd4d59268b3 27293-025 HUMAN OTC DRUG Budpak Antifungal Clotrimazole Clotrimazole CREAM TOPICAL 20121217 OTC MONOGRAPH FINAL part333C Budpak Inc. CLOTRIMAZOLE .01 g/g 27293-026_16ef05c6-c8e0-4de4-b4d3-43d408a0fd7b 27293-026 HUMAN OTC DRUG Budpak Hemorrhoid Anesthetic Mineral Oil, Petrolatum, Phenylephrine HCL OINTMENT TOPICAL 20130610 OTC MONOGRAPH FINAL part346 Budpak Inc. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE .14; .749; .0025 g/g; g/g; g/g 27293-027_05ece84a-9c76-4fa6-a92c-85bcdf79546d 27293-027 HUMAN OTC DRUG Budpak Medicated Anti Itch Camphor and Menthol CREAM TOPICAL 20121217 OTC MONOGRAPH NOT FINAL part348 Budpak Inc. CAMPHOR (SYNTHETIC); MENTHOL .01; .01 g/g; g/g 27293-028_985046ac-f4ae-4c7a-881d-c2491a3a0f6a 27293-028 HUMAN OTC DRUG Budpak Diaper Rash Zinc Oxide CREAM TOPICAL 20140214 OTC MONOGRAPH FINAL part347 Budpak Inc. ZINC OXIDE 13 g/100g 27293-029_0db451f5-a019-431a-87db-8c5a59ba5d32 27293-029 HUMAN OTC DRUG Budpak Petroleum Cocoa Butter White Petrolatum JELLY TOPICAL 20140214 OTC MONOGRAPH FINAL part347 Budpak Inc. PETROLATUM 99.9 g/100g 27293-030_b2cd9dd8-f8e2-4160-8366-bedb2f9dd25f 27293-030 HUMAN OTC DRUG Budpack Muscle Rub Menthol GEL TOPICAL 20120630 OTC MONOGRAPH NOT FINAL part348 Budpack Inc. MENTHOL 2.5 g/100g 27293-033_838d36cc-e9c2-407c-ad94-e8c1cf482ebe 27293-033 HUMAN OTC DRUG Budpak Petroleum Petroleum JELLY TOPICAL 20140707 OTC MONOGRAPH FINAL part347 Budpak Inc. PETROLATUM 100 g/100g 27293-034_a074c4f2-2015-4034-9a7d-8439857b3e6c 27293-034 HUMAN OTC DRUG Budpak Baby TALC POWDER TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part347 Budpak Inc. TALC .9 g/g 27437-106_d307a528-4bb9-476e-9d3e-ec13e8f93f16 27437-106 HUMAN PRESCRIPTION DRUG Alinia nitazoxanide POWDER, FOR SUSPENSION ORAL 20131009 NDA NDA021498 Lupin Pharma NITAZOXANIDE 100 mg/5mL Antiprotozoal [EPC] 27437-107_6bc330b2-bb8b-43ea-92ed-b4a45afe4600 27437-107 HUMAN PRESCRIPTION DRUG Antara fenofibrate CAPSULE ORAL 20131101 NDA NDA021695 LUPIN PHARMA FENOFIBRATE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 27437-108_6bc330b2-bb8b-43ea-92ed-b4a45afe4600 27437-108 HUMAN PRESCRIPTION DRUG Antara fenofibrate CAPSULE ORAL 20131101 NDA NDA021695 LUPIN PHARMA FENOFIBRATE 90 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 27437-109_ab9237aa-f900-4522-9762-c7159e722b24 27437-109 HUMAN PRESCRIPTION DRUG ANTARA FENOFIBRATE CAPSULE ORAL 20090925 NDA NDA021695 LUPIN PHARMA FENOFIBRATE 43 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 27437-110_ab9237aa-f900-4522-9762-c7159e722b24 27437-110 HUMAN PRESCRIPTION DRUG ANTARA FENOFIBRATE CAPSULE ORAL 20090925 NDA NDA021695 LUPIN PHARMA FENOFIBRATE 130 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 27437-143_dbdc8273-3224-4557-b509-f3cf8ce6ccf8 27437-143 HUMAN PRESCRIPTION DRUG AllerNaze Triamcinolone Acetonide SPRAY, METERED NASAL 20110201 NDA NDA020120 Lupin Pharmaceuticals TRIAMCINOLONE ACETONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 27437-201_364fe09d-9218-49ee-810a-88c8adb2ccf7 27437-201 HUMAN PRESCRIPTION DRUG SUPRAX cefixime TABLET ORAL 20080401 ANDA ANDA065130 LUPIN PHARMA CEFIXIME 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 27437-203_364fe09d-9218-49ee-810a-88c8adb2ccf7 27437-203 HUMAN PRESCRIPTION DRUG SUPRAX cefixime TABLET, CHEWABLE ORAL 20121205 ANDA ANDA065380 LUPIN PHARMA CEFIXIME 100 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 27437-205_364fe09d-9218-49ee-810a-88c8adb2ccf7 27437-205 HUMAN PRESCRIPTION DRUG SUPRAX cefixime TABLET, CHEWABLE ORAL 20121205 ANDA ANDA065380 LUPIN PHARMA CEFIXIME 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 27437-206_364fe09d-9218-49ee-810a-88c8adb2ccf7 27437-206 HUMAN PRESCRIPTION DRUG SUPRAX cefixime POWDER, FOR SUSPENSION ORAL 20070601 ANDA ANDA065355 LUPIN PHARMA CEFIXIME 200 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 27437-207_364fe09d-9218-49ee-810a-88c8adb2ccf7 27437-207 HUMAN PRESCRIPTION DRUG SUPRAX cefixime POWDER, FOR SUSPENSION ORAL 20130315 NDA NDA202091 LUPIN PHARMA CEFIXIME 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 27437-208_364fe09d-9218-49ee-810a-88c8adb2ccf7 27437-208 HUMAN PRESCRIPTION DRUG SUPRAX cefixime CAPSULE ORAL 20130315 NDA NDA203195 LUPIN PHARMA CEFIXIME 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 27495-006_77199c68-4209-4ffa-84f0-2ab0103dbce9 27495-006 HUMAN OTC DRUG Dendracin Neurodendraxcin Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part348 Physicians Science & Nature Inc. CAPSAICIN; MENTHOL; METHYL SALICYLATE .0225; 6; 18 mL/60mL; mL/60mL; mL/60mL 27495-008_25fec070-8587-42d1-ba6f-1a9c150acc98 27495-008 HUMAN OTC DRUG Overtime Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part348 Physicians Science & Nature Inc. CAPSAICIN; MENTHOL; METHYL SALICYLATE .0225; 6; 18 mL/60mL; mL/60mL; mL/60mL 27495-010_a08ffd2b-6c78-4a1a-9ca4-08a72900119d 27495-010 HUMAN OTC DRUG ProCoMycin Bacitracin, Neomycin, Polymyxin B and Lidocain Hydrochloride CREAM TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part345 Physicians Science & Nature Inc. BACITRACIN; LIDOCAINE HYDROCHLORIDE; NEOMYCIN; POLYMYXIN B 500; .04; .0035; 10000 [iU]/g; g/g; g/g; [iU]/g 27495-012_72d8e93e-d6a7-47f3-8e10-4bab34eb699a 27495-012 HUMAN OTC DRUG Promolaxin Docusate sodium TABLET ORAL 20110415 OTC MONOGRAPH NOT FINAL part334 Physicians Science & Nature Inc. DOCUSATE SODIUM 100 mg/1 27495-013_990c8328-fc47-4724-8230-3782443349be 27495-013 HUMAN OTC DRUG Acetadryl Acetaminophen and diphenhyramine TABLET, FILM COATED ORAL 20110721 OTC MONOGRAPH NOT FINAL part343 Physicians Science & Nature Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 27495-014_05742cd5-ece2-4007-bdf0-46b76d23df74 27495-014 HUMAN OTC DRUG Dendracin Neurodendraxcin Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20110722 OTC MONOGRAPH NOT FINAL part348 Physicians Science & Nature Inc. CAPSAICIN; MENTHOL; METHYL SALICYLATE .015; 6; 18 mL/60mL; mL/60mL; mL/60mL 27495-018_14b76eca-29f6-4dbd-890b-f72865877ad3 27495-018 HUMAN OTC DRUG Transanosil Methyl Salicylate, Menthol, and Capsaicin LOTION TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 Physicians Science & Nature Inc. CAPSAICIN; MENTHOL; METHYL SALICYLATE .025; 10; 30 g/100mL; g/100mL; g/100mL 27505-002_44f85cf2-50c5-40c4-9da3-b2428e5b7c4e 27505-002 HUMAN PRESCRIPTION DRUG ALSUMA (sumatriptan injection) 6mg/0.5mL, auto-injector INJECTION, SOLUTION SUBCUTANEOUS 20101015 NDA NDA022377 US WorldMeds, LLC SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 27505-003_8fb5268f-1213-495b-abae-ebf5800ea5f2 27505-003 HUMAN PRESCRIPTION DRUG Revonto dantrolene sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120604 20170331 ANDA ANDA078378 US WorldMeds, LLC DANTROLENE SODIUM 20 mg/60mL Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] 27505-003_b521ca94-e4b6-47b1-a9be-4c99c93cd6b8 27505-003 HUMAN PRESCRIPTION DRUG Revonto dantrolene sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120604 ANDA ANDA078378 US WorldMeds, LLC DANTROLENE SODIUM 20 mg/60mL Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] 27505-004_17f847db-a361-40d1-9531-99a0c534ed15 27505-004 HUMAN PRESCRIPTION DRUG APOKYN APOMORPHINE HYDROCHLORIDE INJECTION SUBCUTANEOUS 20040702 NDA NDA021264 US WorldMeds, LLC APOMORPHINE HYDROCHLORIDE 30 mg/3mL Dopamine Agonists [MoA],Dopaminergic Agonist [EPC] 27789-911_d92d370f-3f7f-4b8f-8a6e-99b9920e5c17 27789-911 HUMAN OTC DRUG Zcaine Fast Acting Anesthetic LIDOCAINE GEL TOPICAL 20120404 OTC MONOGRAPH FINAL part348 PHI, Inc LIDOCAINE 4 g/100g 27808-001_811199b0-3b4b-47c1-918b-751fc1b9cbee 27808-001 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride LIQUID ORAL 20121121 ANDA ANDA090572 Tris Pharma Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 27808-001_e20d227a-86c2-4cea-b505-5c1bb28fa4b3 27808-001 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride LIQUID ORAL 20121121 ANDA ANDA090572 Tris Pharma Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 27808-002_f3f40799-0016-47d8-b20d-8e6d085eb4c6 27808-002 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20121212 ANDA ANDA079059 Tris Pharma Inc RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] 27808-007_7e1cdb78-1596-4349-b87c-bd27dac70e78 27808-007 HUMAN OTC DRUG Concentrated Ibuprofen Concentrated Ibuprofen SUSPENSION ORAL 20121106 ANDA ANDA079058 Tris Phrama Inc IBUPROFEN 50 mg/1.25mL 27808-023_f79ca51e-2252-47fd-9a40-864c8b6b71e7 27808-023 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20121019 ANDA ANDA090461 Tris Pharma Inc LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 27808-029_672c1f71-9982-41ee-93d4-0fa0a09d0cda 27808-029 HUMAN PRESCRIPTION DRUG Nexiclon XR Clonidine FOR SUSPENSION, EXTENDED RELEASE ORAL 20101217 NDA NDA022499 Tris Pharma, Inc. CLONIDINE .09 mg/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 27808-030_bd1c7c7d-6549-41ec-87e1-b40ec1fc3c30 27808-030 HUMAN PRESCRIPTION DRUG Nexiclon Clonidine TABLET, EXTENDED RELEASE ORAL 20101217 NDA NDA022500 Tris Pharma, Inc. CLONIDINE .17 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 27808-031_bd1c7c7d-6549-41ec-87e1-b40ec1fc3c30 27808-031 HUMAN PRESCRIPTION DRUG Nexiclon XR Clonidine TABLET, EXTENDED RELEASE ORAL 20101217 NDA NDA022500 Tris Pharma, Inc. CLONIDINE .26 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 27808-033_0c3509ba-b49d-4d18-86b4-e3bafb54fca2 27808-033 HUMAN PRESCRIPTION DRUG Theophylline Theophylline SOLUTION ORAL 20120802 ANDA ANDA091586 Tris Pharma Inc THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 27808-035_aecd8c65-ebcb-404b-b94f-d72527967387 27808-035 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141006 ANDA ANDA202214 Tris Pharma Inc ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 27808-036_aecd8c65-ebcb-404b-b94f-d72527967387 27808-036 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141006 ANDA ANDA202214 Tris Pharma Inc ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 27808-037_aecd8c65-ebcb-404b-b94f-d72527967387 27808-037 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141006 ANDA ANDA202214 Tris Pharma Inc ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 27808-051_c73a0c40-fa54-41f6-83c1-72ad839934b7 27808-051 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SYRUP ORAL 20120803 ANDA ANDA091675 Tris Pharma Inc PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 27808-057_30f963ea-a91f-4661-a7a3-082caf1309b5 27808-057 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextromethorphan Hydrobromide Promethazine Hydrochloride and Dextromethorphan Hydrobromide SYRUP ORAL 20140131 ANDA ANDA091687 Tris Pharma Inc DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] 27808-065_54925647-b1fb-46cd-80ef-8ca652f6749a 27808-065 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Codeine Phosphate Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20130515 ANDA ANDA200386 Tris Pharma Inc CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 27808-071_aaf2e2d0-addb-470a-bd10-adc8f9bc9881 27808-071 HUMAN OTC DRUG Dextromethorphan Polistirex Dextromethorphan Polistirex SUSPENSION, EXTENDED RELEASE ORAL 20141116 ANDA ANDA091135 Tris Pharma Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 27808-085_fb7e324a-c6d5-4dc5-b1a4-a397df1fca5a 27808-085 HUMAN PRESCRIPTION DRUG Dextroamphetamine Dextroamphetamine SOLUTION ORAL 20130531 ANDA ANDA203644 Tris Pharma Inc DEXTROAMPHETAMINE SULFATE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 27808-088_c73efcd9-eade-4647-a912-e968eb3b2e8b 27808-088 HUMAN PRESCRIPTION DRUG Hydrocodone bitartrate and pseudoephedrine hydrochloride solution Hydrocodone bitartrate and pseudoephedrine hydrochloride SOLUTION ORAL 20141231 ANDA ANDA203839 Tris Pharma Inc HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 60 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] CII 27854-101_6f8fced3-00c0-4e07-9c24-1640245c95cb 27854-101 HUMAN OTC DRUG Flanax Antacid Aluminum Hydroxide, Magnesium Hydroxide, and Dimethicone LIQUID ORAL 20121206 OTC MONOGRAPH FINAL part331 Belmora LLC ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 14.2; 1.4; 14.2 g/355mL; g/355mL; g/355mL 27854-103_5408e114-82da-402c-b6b2-a153e1b4d31b 27854-103 HUMAN OTC DRUG Flanax Pain Reliever Naproxen Sodium TABLET ORAL 20121206 ANDA ANDA079096 Belmora LLC NAPROXEN SODIUM 220 mg/1 27854-105_98a939f3-d92c-42e4-ac22-2d68f866d0e8 27854-105 HUMAN OTC DRUG Flanax Aspirin Pain Reliever Aspirin TABLET ORAL 20121206 OTC MONOGRAPH FINAL part343 Belmora LLC ASPIRIN 325 mg/1 28064-056_aa4c5d83-8ef9-4a9a-b164-9a14b68f4ee0 28064-056 HUMAN OTC DRUG Instant Hand Sanitizer Instant Hand Sanitizer SOLUTION TOPICAL 20131105 OTC MONOGRAPH NOT FINAL part333A Knight Facilities Management, Inc. ALCOHOL 62 mL/100mL 28064-515_9c91cc75-b82a-4b33-8221-9551c1a91ad6 28064-515 HUMAN OTC DRUG Facility Maintenance Instant Hand Sanitizer HS-67 ALCOHOL GEL TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Knight Facilities Management, Inc. ALCOHOL 600 mL/1000mL 28105-149_19741b55-154b-4182-a408-1a2e312269aa 28105-149 HUMAN PRESCRIPTION DRUG Derma-Smoothe/FS fluocinolone acetonide OIL TOPICAL 19950216 NDA NDA019452 Hill Dermaceuticals, Inc. FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 28105-150_6f3627de-3854-4ada-9e3d-1693a92c578a 28105-150 HUMAN PRESCRIPTION DRUG Derma-Smoothe/FS fluocinolone acetonide OIL TOPICAL 19880203 NDA NDA019452 Hill Dermaceuticals, Inc. FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 28105-160_5316e12c-827b-4f63-85ef-0c7b5b809cd6 28105-160 HUMAN PRESCRIPTION DRUG DermOtic fluocinolone acetonide OIL AURICULAR (OTIC) 20051109 NDA NDA019452 Hill Dermaceuticals, Inc. FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 28107-002_f7af3c71-1a86-4bdb-9714-3f1b227adeb8 28107-002 HUMAN OTC DRUG CleanWell Natural Original Hand Sanitizer Wipes CleanWell Natural Original Hand Sanitizer Wipes CLOTH TOPICAL 20100615 OTC MONOGRAPH NOT FINAL part356 CleanWell THYMOL .0005 kg/kg 28107-003_c0ca8159-e199-45ca-b606-fc45381f4f9b 28107-003 HUMAN OTC DRUG Ginger Bergamot Natural Antibacterial Foaming Ginger Bergamot Natural Antibacterial Foaming SOAP TOPICAL 20071101 OTC MONOGRAPH NOT FINAL part356 CleanWell THYMOL .0004 kg/kg 28107-004_f1a50395-f0bd-431e-94f3-0d42a1aff6b0 28107-004 HUMAN OTC DRUG CleanWell Natural Antibacterial Foaming Orange Vanilla CleanWell Natural Antibacterial Foaming Orange Vanilla SOAP TOPICAL 20071101 OTC MONOGRAPH NOT FINAL part356 CleanWell THYMOL .0004 1/kg 28107-005_51ddb0be-272e-49c5-9503-4e0492e26b03 28107-005 HUMAN OTC DRUG CLEANWELL NATURAL ANTIBACTERIAL FOAMING LAVENDER CLEANWELL NATURAL ANTIBACTERIAL FOAMING LAVENDER SOAP TOPICAL 20071101 OTC MONOGRAPH NOT FINAL part356 CleanWell THYMOL .0004 kg/kg 28107-006_0566efd1-d393-4c2f-af37-ce69b2d5a9ae 28107-006 HUMAN OTC DRUG CleanWell Natural Antibacterial Foaming Spearmint Lime CleanWell Natural Antibacterial Foaming Spearmint Lime SOAP TOPICAL 20071101 OTC MONOGRAPH NOT FINAL part356 CleanWell THYMOL .0004 kg/kg 28107-007_b5dd246d-86d9-4303-9d58-ea521f0601a3 28107-007 HUMAN OTC DRUG CleanWell Natural Orange Vanilla Hand Sanitizing Wipes CleanWell Natural Orange Vanilla Hand Sanitizing Wipes CLOTH TOPICAL 20100615 OTC MONOGRAPH NOT FINAL part356 CleanWell THYMOL .0005 kg/kg 28107-008_7dc09386-5e2b-4b3a-8353-65f207fd854d 28107-008 HUMAN OTC DRUG CleanWell Natural Orange Vanilla Hand Sanitizer CleanWell Natural Orange Vanilla Hand Sanitizer SPRAY TOPICAL 20071101 OTC MONOGRAPH NOT FINAL part356 CleanWell THYMOL .0005 kg/kg 28107-009_f4ac0832-29b1-4dc2-ab64-9ea323f08a92 28107-009 HUMAN OTC DRUG Natures Antibac Orange Vanilla Natures Antibac Orange Vanilla SOAP TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part356 CleanWell THYMOL .0024 kg/kg 28107-010_fe95324a-327d-4ef1-8313-9f43b5532b88 28107-010 HUMAN OTC DRUG Natures Antibac Peppermint Natures Antibac Peppermint SOAP TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part356 CleanWell THYMOL .0024 kg/kg 28107-011_56115b9c-78a6-42e5-88a4-a415db109b17 28107-011 HUMAN OTC DRUG Natures Antibac Lavender Natures Antibac Lavender SOAP TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part356 CleanWell THYMOL .0024 kg/kg 28109-010_43c8f760-7c5c-407c-91ce-674bd13b4ecd 28109-010 HUMAN OTC DRUG AcneWorx salicylic acid GEL TOPICAL 20080114 OTC MONOGRAPH FINAL part333 DermWorx Incorporated SALICYLIC ACID .6 g/30mL 28109-020_e627fee6-666a-4bb0-b0a1-cb6e94df03ee 28109-020 HUMAN OTC DRUG MoistureWorx petrolatum SPRAY TOPICAL 20080527 OTC MONOGRAPH FINAL part347 DermWorx Incorporated PETROLATUM 36 mL/120mL 28400-105_73084639-657b-4b47-bcca-0ce1944fe6f9 28400-105 PLASMA DERIVATIVE RECOTHROM Thrombin, topical (Recombinant) KIT 20080129 BLA BLA125248 ZymoGenetics, Inc. 28400-120_73084639-657b-4b47-bcca-0ce1944fe6f9 28400-120 PLASMA DERIVATIVE RECOTHROM Thrombin, topical (Recombinant) KIT 20080609 BLA BLA125248 ZymoGenetics, Inc. 28475-810_43824b60-0dbd-47c9-b1ed-8cf4dc94eff0 28475-810 HUMAN OTC DRUG PrevinC LEMON SOLUTION NASAL 20101010 UNAPPROVED HOMEOPATHIC BioHealth Technologies Inc. LEMON 1 [hp_X]/5mL 28595-300_be486bc9-6a4f-4c41-8ca9-a2899edbd743 28595-300 HUMAN OTC DRUG Brohist D Brompheniramine Maleate and Phenylephrine Hydrochloride TABLET, COATED ORAL 20120910 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 28595-420_6da77968-9e74-4798-8a87-6d4f4a87b817 28595-420 HUMAN PRESCRIPTION DRUG Otozin Antipyrine, Benzocaine, and Zinc Acetate SOLUTION TOPICAL 20110506 UNAPPROVED DRUG OTHER Allegis Pharmaceuticals, LLC ANTIPYRINE; BENZOCAINE; ZINC ACETATE 54; 10; 10 mg/mL; mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 28595-500_2b616305-bbc8-4e8c-83d8-4a0045f323d4 28595-500 HUMAN PRESCRIPTION DRUG DermaNIC NIACINAMIDE, INOSITOL NIACINATE, NIACIN, CHROMIUM NICOTINATE, FOLIC ACID, HYDROXOCOBALAMIN, FERROUS CYSTEINE GLYCINATE, and ACETYLCYSTEINE ZINC TABLET ORAL 20140203 UNAPPROVED DRUG OTHER Allegis Pharmaceuticals, LLC ACETYLCYSTEINE ZINC; CHROMIUM NICOTINATE; FERROUS CYSTEINE GLYCINATE; FOLIC ACID; HYDROXOCOBALAMIN; INOSITOL NIACINATE; NIACIN; NIACINAMIDE 69.5; .57; 1.5; 500; 15; 328; 1.5; 498 mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Antidote [EPC],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 28595-570_9a1036fd-3e9e-49e8-900b-6f1b933ba527 28595-570 HUMAN PRESCRIPTION DRUG Spinosad spinosad SUSPENSION TOPICAL 20140625 NDA NDA022408 Allegis Pharmaceuticals, LLC SPINOSAD 9 mg/mL Pediculicide [EPC] 28595-780_52cf1494-9ab8-4ed1-9061-5d192c204846 28595-780 HUMAN OTC DRUG HistaFlex ACETAMINOPHEN and PYRILAMINE MALEATE TABLET ORAL 20140522 OTC MONOGRAPH NOT FINAL part343 Allegis Pharmaceuticals, LLC ACETAMINOPHEN; PYRILAMINE MALEATE 325; 25 mg/1; mg/1 28595-800_aa07b430-abc9-492f-818b-9fa94c5f7490 28595-800 HUMAN OTC DRUG AP-Hist DM Brompheniramine Maleate, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide LIQUID ORAL 20130415 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 15; 7.5 mg/mL; mg/mL; mg/mL 28595-801_41079447-f4b9-4da6-8ed2-f6810eb2346f 28595-801 HUMAN OTC DRUG HISTEX PD Drops TRIPROLIDINE HYDROCHLORIDE SYRUP ORAL 20140306 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC TRIPROLIDINE HYDROCHLORIDE .938 mg/mL 28595-802_d54fba80-fcd0-4fc5-9870-1e3e6e7b51ea 28595-802 HUMAN OTC DRUG HISTEX TRIPROLIDINE HYDROCHLORIDE SYRUP ORAL 20140304 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC TRIPROLIDINE HYDROCHLORIDE 2.5 mg/5mL 28595-803_660edee9-4a95-4a0b-b951-c5283293c626 28595-803 HUMAN OTC DRUG HISTEX-PE PHENYLEPHRINE HYDROCHLORIDE and TRIPROLIDINE HYDROCHLORIDE SYRUP ORAL 20140317 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 10; 2.5 mg/5mL; mg/5mL 28595-804_ac2157ef-390a-4c6d-a304-9e78aae1294d 28595-804 HUMAN OTC DRUG HISTEX-DM DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and TRIPROLIDINE HYDROCHLORIDE SYRUP ORAL 20140319 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 20; 10; 2.5 mg/5mL; mg/5mL; mg/5mL 28595-900_7dcb52dc-f40f-4c24-b866-5d18ef4f3e2c 28595-900 HUMAN OTC DRUG Ru-Hist D Brompheniramine Maleate and Phenylephrine Hydrochloride TABLET, COATED ORAL 20131101 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 28595-905_a8aa7148-a219-4c68-895c-b3753d730526 28595-905 HUMAN OTC DRUG Duravent PE GUAIFENESIN and PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20140227 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 395; 10 mg/1; mg/1 28595-906_505ea130-06ab-47a3-8dde-60987f5089b6 28595-906 HUMAN OTC DRUG Duravent DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20140227 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 395; 10 mg/1; mg/1; mg/1 28623-250_59e56496-8403-491a-942c-dfd42cbfa5f7 28623-250 HUMAN OTC DRUG Cough and Cold XL3 Xtra Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130301 OTC MONOGRAPH FINAL part341 Progela, S.A. de C.V. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 250; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 28691-0025_95c527a8-7073-421a-b22a-9b0ba0b5fd4e 28691-0025 HUMAN OTC DRUG Capsaicin Capsaicin PATCH TOPICAL 20140111 OTC MONOGRAPH NOT FINAL part348 Pharmaplast SAE CAPSAICIN .6 mg/1 28691-0100_b4887327-63b1-4219-9c54-fe255606f291 28691-0100 HUMAN OTC DRUG Antiseptic Bandages Benzalkonium chloride DRESSING TOPICAL 20140109 OTC MONOGRAPH NOT FINAL part333E Pharmaplast SAE BENZALKONIUM CHLORIDE .042 mg/1 28691-0838_0cdf38fc-3f3b-4c50-8e7f-628f825f33c3 28691-0838 HUMAN OTC DRUG Wart Remover Salicylic Acid PLASTER TOPICAL 20100901 OTC MONOGRAPH FINAL part358B Pharmaplast SAE SALICYLIC ACID 40 mL/1 28691-1000_c71b4de6-31d0-4d3a-8713-56d4e3b13125 28691-1000 HUMAN OTC DRUG Cure-Aid POVI Adhesive Bandage Povidone Iodine PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part333C Pharmaplast SAE POVIDONE-IODINE 100 mg/1 28691-1234_9e869a43-5ea9-49e3-a95b-fc758a9e097b 28691-1234 HUMAN OTC DRUG Alcohol swab Alcohol swab SWAB TOPICAL 20070101 UNAPPROVED DRUG OTHER Pharmaplast SAE ALCOHOL .7 mL/mL 28691-2500_9d9b9739-8b1b-4be2-85a7-d375074d8786 28691-2500 HUMAN OTC DRUG UNNAPLAST Zinc Oxide PASTE TOPICAL 20140101 OTC MONOGRAPH FINAL part347 Pharmaplast SAE ZINC OXIDE 5 mg/cm2 28691-2501_5210e755-5466-4622-a051-15e4a47b3131 28691-2501 HUMAN OTC DRUG UNNAPLAST with CALAMINE Zinc Oxide and Calamine PASTE TOPICAL 20140101 OTC MONOGRAPH FINAL part347 Pharmaplast SAE FERRIC OXIDE RED; ZINC OXIDE .2; 5 mg/cm2; mg/cm2 28691-4000_7cc6c1ce-5cec-4d36-82cc-3cd6dfe072e1 28691-4000 HUMAN OTC DRUG Cure-Aid Corn Plasters Salicylic acid PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part358B Pharmaplast SAE SALICYLIC ACID 40 mg/1 28851-690_6fb36050-9f40-461c-87e0-48a3603b4339 28851-690 HUMAN OTC DRUG Kendall 2-in-1 Cleanser Dimethicone LIQUID TOPICAL 20110405 OTC MONOGRAPH FINAL part347 Covidien Inc. DIMETHICONE 1.5 mL/100mL 28851-691_dfd328d2-3c26-4e97-8a00-f0429bfaea4a 28851-691 HUMAN OTC DRUG Kendall Antimicrobial Cleanser Benzalkonium Chloride LIQUID TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333A Covidien Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 28851-692_c12520f1-5f04-406a-b40e-7234ff61ee61 28851-692 HUMAN OTC DRUG Kendall Antifungal Miconazole nitrate CREAM TOPICAL 20110414 OTC MONOGRAPH FINAL part333C Covidien Inc. MICONAZOLE NITRATE 2 g/100g 28851-693_ee8f1c36-5798-43d1-a48a-dec2563ce58b 28851-693 HUMAN OTC DRUG Kendall Moisture Barrier Dimethicone CREAM TOPICAL 20110421 OTC MONOGRAPH FINAL part347 Covidien Inc. DIMETHICONE 5 mL/100mL 28851-694_c49f81d4-7fd5-4b90-a790-37c3ba8d1560 28851-694 HUMAN OTC DRUG Kendall Moisturizing Dimethicone LOTION TOPICAL 20110420 OTC MONOGRAPH FINAL part347 Covidien Inc. DIMETHICONE 1.5 mL/100mL 28851-695_472d414c-1970-415f-b1ab-85bd657d6e74 28851-695 HUMAN OTC DRUG Kendall Soothing Zinc Oxide OINTMENT TOPICAL 20110422 OTC MONOGRAPH FINAL part347 Covidien Inc. ZINC OXIDE 10 mL/100mL 28877-0070_5ed1b9af-3a19-40f8-a925-e62b1d8f0558 28877-0070 HUMAN PRESCRIPTION DRUG Xyzal levocetirizine dihydrochloride TABLET ORAL 20080219 NDA NDA022064 UCB Farchim S.A. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 28877-5960_83513507-0109-4371-bb7a-bd84ea66b6ff 28877-5960 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET ORAL 20000424 NDA NDA021035 UCB Farchim S.A. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 28877-5970_ac2547d0-6daf-41de-845b-c4cb14dba77e 28877-5970 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET ORAL 20000424 NDA NDA021035 UCB Farchim S.A. LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 29033-001_ce987ad4-8726-49b0-877b-f7394f5af389 29033-001 HUMAN PRESCRIPTION DRUG Theophylline (Anhydrous) Theophylline TABLET, EXTENDED RELEASE ORAL 20070601 ANDA ANDA040595 Nostrum Laboratories, Inc. THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 29033-002_ce987ad4-8726-49b0-877b-f7394f5af389 29033-002 HUMAN PRESCRIPTION DRUG Theophylline (Anhydrous) Theophylline TABLET, EXTENDED RELEASE ORAL 20070601 ANDA ANDA040560 Nostrum Laboratories, Inc. THEOPHYLLINE ANHYDROUS 600 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 29033-003_a1cb25b2-b8b8-4074-afc9-3038dc157c3f 29033-003 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20090701 ANDA ANDA074415 Nostrum Laboratories, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 29033-004_db486844-0546-4191-9023-d05533ce0707 29033-004 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20110520 ANDA ANDA076697 Nostrum Laboratories, Inc. CARBAMAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 29033-012_ab1e46b4-fbf0-4b24-bc64-8ecf077d1328 29033-012 HUMAN PRESCRIPTION DRUG Piroxicam piroxicam CAPSULE ORAL 20100105 ANDA ANDA074116 Nostrum Laboratories, Inc. PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 29033-013_ab1e46b4-fbf0-4b24-bc64-8ecf077d1328 29033-013 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20100105 ANDA ANDA074118 Nostrum Laboratories, Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 29033-018_f967d166-5738-4b5f-89d5-c3223d2345dd 29033-018 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20120101 ANDA ANDA076756 Nostrum Laboratories Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 29033-019_cd61308b-47fd-418a-a7af-5b6b2723a9e3 29033-019 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20110520 ANDA ANDA076697 Nostrum Laboratories, Inc. CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 29033-020_cd61308b-47fd-418a-a7af-5b6b2723a9e3 29033-020 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20110520 ANDA ANDA076697 Nostrum Laboratories, Inc. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 29033-021_f967d166-5738-4b5f-89d5-c3223d2345dd 29033-021 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20120101 ANDA ANDA076756 Nostrum Laboratories Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 29149-001_1c5d16ce-79f1-496d-bb60-29867965a8ba 29149-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20080801 UNAPPROVED MEDICAL GAS Landmark Healthcare, Inc. OXYGEN 990 mL/L 29300-111_1515ef5b-c2d9-4416-abee-e7ae89dc11c0 29300-111 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111101 ANDA ANDA090170 Unichem Pharmaceuticals (USA), Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 29300-112_1515ef5b-c2d9-4416-abee-e7ae89dc11c0 29300-112 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111101 ANDA ANDA090170 Unichem Pharmaceuticals (USA), Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 29300-113_1515ef5b-c2d9-4416-abee-e7ae89dc11c0 29300-113 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111101 ANDA ANDA090170 Unichem Pharmaceuticals (USA), Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 29300-114_1515ef5b-c2d9-4416-abee-e7ae89dc11c0 29300-114 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111101 ANDA ANDA090170 Unichem Pharmaceuticals (USA), Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 29300-115_5ed5ebbf-5323-4e4e-ae73-ef3d5f711290 29300-115 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20130701 ANDA ANDA090162 Unichem Pharmaceuticals (USA), Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 29300-116_5ed5ebbf-5323-4e4e-ae73-ef3d5f711290 29300-116 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20130701 ANDA ANDA090162 Unichem Pharmaceuticals (USA), Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 29300-117_5ed5ebbf-5323-4e4e-ae73-ef3d5f711290 29300-117 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20130701 ANDA ANDA090162 Unichem Pharmaceuticals (USA), Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 29300-118_5ed5ebbf-5323-4e4e-ae73-ef3d5f711290 29300-118 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20130701 ANDA ANDA090162 Unichem Pharmaceuticals (USA), Inc. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 29300-124_98dffbe5-6178-400a-aaf0-f606a0d5700d 29300-124 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Unichem Pharmaceuticals (USA), Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 29300-125_98dffbe5-6178-400a-aaf0-f606a0d5700d 29300-125 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Unichem Pharmaceuticals (USA), Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 29300-126_a324686c-e1d6-45e1-82e9-557e1e9d003a 29300-126 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol fumarate TABLET ORAL 20090921 ANDA ANDA078635 Unichem Pharmaceuticals (USA), Inc. BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 29300-127_a324686c-e1d6-45e1-82e9-557e1e9d003a 29300-127 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol fumarate TABLET ORAL 20090921 ANDA ANDA078635 Unichem Pharmaceuticals (USA), Inc. BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 29300-128_d2cbe57b-6bd5-4114-b97c-982d7bf3ceae 29300-128 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20090702 ANDA ANDA040907 Unichem Pharmaceuticals (USA), Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 29300-129_d2cbe57b-6bd5-4114-b97c-982d7bf3ceae 29300-129 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20090702 ANDA ANDA040907 Unichem Pharmaceuticals (USA), Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 29300-130_0b032076-db19-464e-9045-28f48d952e53 29300-130 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20100315 ANDA ANDA090510 Unichem Pharmaceuticals (USA), Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 29300-131_6c398e7b-c9c1-4c11-abc2-58be0f21403e 29300-131 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Unichem Pharmaceuticals (USA), Inc. ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 29300-132_6c398e7b-c9c1-4c11-abc2-58be0f21403e 29300-132 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Unichem Pharmaceuticals (USA), Inc. ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 29300-133_214c8297-d4f7-49ad-9058-593d5cbfbc84 29300-133 HUMAN OTC DRUG cetirizine hydrochloride cetirizine hydrochloride TABLET ORAL 20101130 ANDA ANDA078680 Unichem Pharmaceuticals (USA), Inc. CETIRIZINE HYDROCHLORIDE 5 mg/1 29300-134_214c8297-d4f7-49ad-9058-593d5cbfbc84 29300-134 HUMAN OTC DRUG cetirizine hydrochloride cetirizine hydrochloride TABLET ORAL 20101130 ANDA ANDA078680 Unichem Pharmaceuticals (USA), Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 29300-135_a24ca5b5-fcac-4a64-8a3d-de89dde9575b 29300-135 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Unichem Pharmaceuticals (USA), Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 29300-136_a24ca5b5-fcac-4a64-8a3d-de89dde9575b 29300-136 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Unichem Pharmaceuticals (USA), Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 29300-137_a24ca5b5-fcac-4a64-8a3d-de89dde9575b 29300-137 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Unichem Pharmaceuticals (USA), Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 29300-138_905eac57-e1e2-42e9-9c2b-b81d302a5b61 29300-138 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 Unichem Pharmaceuticals (USA), Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 29300-139_905eac57-e1e2-42e9-9c2b-b81d302a5b61 29300-139 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 Unichem Pharmaceuticals (USA), Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 29300-140_905eac57-e1e2-42e9-9c2b-b81d302a5b61 29300-140 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 Unichem Pharmaceuticals (USA), Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 29300-168_6902e0a8-08aa-405a-abf3-b2ec56dad1ca 29300-168 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20130401 ANDA ANDA091283 Unichem Pharmaceuticals (USA), Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 29300-169_6902e0a8-08aa-405a-abf3-b2ec56dad1ca 29300-169 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20130401 ANDA ANDA091283 Unichem Pharmaceuticals (USA), Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 29300-187_f7f431c1-2943-4dd9-b101-d50d56e5fa71 29300-187 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 Unichem Pharmaceuticals (USA), Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5; 6.25 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 29300-188_f7f431c1-2943-4dd9-b101-d50d56e5fa71 29300-188 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 Unichem Pharmaceuticals (USA), Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 29300-189_f7f431c1-2943-4dd9-b101-d50d56e5fa71 29300-189 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 Unichem Pharmaceuticals (USA), Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 29300-226_3ef0fab5-cc38-4518-9b40-2263fe78e268 29300-226 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 Unichem Pharmaceuticals (USA), Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 29300-227_3ef0fab5-cc38-4518-9b40-2263fe78e268 29300-227 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 Unichem Pharmaceuticals (USA), Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 29300-241_291e6a9e-0759-45a7-9f7d-58514b87341d 29300-241 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 Unichem Pharmaceuticals (USA), Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 29300-242_291e6a9e-0759-45a7-9f7d-58514b87341d 29300-242 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 Unichem Pharmaceuticals (USA), Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 29300-243_291e6a9e-0759-45a7-9f7d-58514b87341d 29300-243 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 Unichem Pharmaceuticals (USA), Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 29300-330_1be5f142-059a-45be-8553-058ffd7fa414 29300-330 HUMAN OTC DRUG cetirizine hydrochloride cetirizine hydrochloride TABLET ORAL 20101130 ANDA ANDA078680 Unichem Pharmaceuticals (USA), Inc. CETIRIZINE HYDROCHLORIDE 5 mg/1 29300-340_1be5f142-059a-45be-8553-058ffd7fa414 29300-340 HUMAN OTC DRUG cetirizine hydrochloride cetirizine hydrochloride TABLET ORAL 20101130 ANDA ANDA078680 Unichem Pharmaceuticals (USA), Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 29333-0001_18baeaac-60d9-43fb-986b-317a2fedfcc7 29333-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070201 UNAPPROVED MEDICAL GAS O24U OXYGEN 99 L/100L 29336-200_efbfede7-656c-42cf-bbdc-5fa1b042f81f 29336-200 HUMAN PRESCRIPTION DRUG MetroGel-Vaginal metronidazole GEL VAGINAL 20100101 20150131 NDA NDA020014 Graceway Pharmaceuticals, LLC METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 29336-301_d1e0020c-2fd3-920a-f196-2e1079eae8f4 29336-301 HUMAN PRESCRIPTION DRUG Minitran nitroglycerin PATCH TRANSDERMAL 20070401 ANDA ANDA089771 Graceway Pharmaceuticals, LLC NITROGLYCERIN 2.5 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 29336-302_d1e0020c-2fd3-920a-f196-2e1079eae8f4 29336-302 HUMAN PRESCRIPTION DRUG Minitran nitroglycerin PATCH TRANSDERMAL 20070401 ANDA ANDA089772 Graceway Pharmaceuticals, LLC NITROGLYCERIN 5 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 29336-303_d1e0020c-2fd3-920a-f196-2e1079eae8f4 29336-303 HUMAN PRESCRIPTION DRUG Minitran nitroglycerin PATCH TRANSDERMAL 20090810 ANDA ANDA089773 Graceway Pharmaceuticals, LLC NITROGLYCERIN 10 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 29336-304_d1e0020c-2fd3-920a-f196-2e1079eae8f4 29336-304 HUMAN PRESCRIPTION DRUG Minitran nitroglycerin PATCH TRANSDERMAL 20070401 ANDA ANDA089774 Graceway Pharmaceuticals, LLC NITROGLYCERIN 15 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 29336-321_590f4d2a-cb56-0b3e-4301-7bf5c148e3a0 29336-321 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20070401 ANDA ANDA089771 Graceway Pharmaceuticals, LLC NITROGLYCERIN 2.5 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 29336-322_590f4d2a-cb56-0b3e-4301-7bf5c148e3a0 29336-322 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20070401 ANDA ANDA089772 Graceway Pharmaceuticals, LLC NITROGLYCERIN 5 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 29336-323_590f4d2a-cb56-0b3e-4301-7bf5c148e3a0 29336-323 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20070404 ANDA ANDA089773 Graceway Pharmaceuticals, LLC NITROGLYCERIN 10 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 29336-324_590f4d2a-cb56-0b3e-4301-7bf5c148e3a0 29336-324 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20070401 ANDA ANDA089774 Graceway Pharmaceuticals, LLC NITROGLYCERIN 15 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 29336-400_63386e33-7f14-5d5f-b789-6be6bd151049 29336-400 HUMAN PRESCRIPTION DRUG Calcium Disodium Versenate edetate calcium disodium INJECTION INTRAMUSCULAR 20090709 NDA NDA008922 Graceway Pharmaceuticals, LLC EDETATE CALCIUM DISODIUM 200 mg/mL Lead Chelating Activity [MoA],Lead Chelator [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 29336-610_e4130964-351b-4b09-8874-0a5eead65c64 29336-610 HUMAN PRESCRIPTION DRUG Aldara imiquimod CREAM TOPICAL 20110624 20150131 NDA NDA020723 Graceway Pharmaceuticals, LLC IMIQUIMOD 50 mg/1000mg Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 29336-710_60452b8f-e4ad-4a99-9777-ea1cb9394fc6 29336-710 HUMAN PRESCRIPTION DRUG Zyclara imiquimod CREAM TOPICAL 20110815 20150131 NDA NDA022483 Graceway Pharmaceuticals, LLC IMIQUIMOD 3.75 mg/100mg Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 29336-750_60452b8f-e4ad-4a99-9777-ea1cb9394fc6 29336-750 HUMAN PRESCRIPTION DRUG Zyclara imiquimod CREAM TOPICAL 20111015 20150131 NDA NDA022483 Graceway Pharmaceuticals, LLC IMIQUIMOD 3.75 mg/100mg Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 29336-910_60452b8f-e4ad-4a99-9777-ea1cb9394fc6 29336-910 HUMAN PRESCRIPTION DRUG Zyclara imiquimod CREAM TOPICAL 20110415 20150131 NDA NDA022483 Graceway Pharmaceuticals, LLC IMIQUIMOD 2.5 mg/100mg Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 29485-1073_0184b46f-48de-4566-a55d-7ee56b366e08 29485-1073 HUMAN OTC DRUG REFRESH TEARS carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20100101 OTC MONOGRAPH FINAL part349 Mechanical Servants, Inc. CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL 29485-2827_a22863d6-9aef-4758-83cd-beafe91f3bb3 29485-2827 HUMAN OTC DRUG Vicks DayQuil Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20100101 OTC MONOGRAPH FINAL part341 Mechanical Servants, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 29485-2828_a4a169f7-c4ae-401c-9dfc-170cbbf7c4a9 29485-2828 HUMAN OTC DRUG Vicks NyQuil Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20100101 OTC MONOGRAPH FINAL part341 Mechanical Servants, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 29485-6741_92448d56-6df2-40f1-9d69-2f42999ae3c0 29485-6741 HUMAN OTC DRUG Dulcolax bisacodyl TABLET, COATED ORAL 20100101 OTC MONOGRAPH NOT FINAL part334 Mechanical Servants, Inc. BISACODYL 5 mg/1 29500-0035_72e86b8b-85fb-4c8b-9d9b-15d2b3258915 29500-0035 HUMAN OTC DRUG Personal Care Antifungal TOLNAFTATE SPRAY TOPICAL 20100521 OTC MONOGRAPH FINAL part333C Personal Care Products, Inc. TOLNAFTATE 1 g/100g 29500-0177_adc8053d-b1fb-410b-ba7c-f03d1dd5ea33 29500-0177 HUMAN OTC DRUG Oil Free Acne Wash SALICYLIC ACID LIQUID TOPICAL 20100523 OTC MONOGRAPH FINAL part358H Personal Care Products, Inc. SALICYLIC ACID 2 mL/100mL 29500-0240_4f6da6b3-1de6-40d4-8ef5-414dc35d0ead 29500-0240 HUMAN OTC DRUG Sensitive Skin Deep Cleaning Astringent Salicylic Acid LIQUID TOPICAL 20100523 OTC MONOGRAPH FINAL part358H Personal Care Productrs SALICYLIC ACID .5 mL/100mL 29500-0241_d2e8008f-af55-4820-ac5d-3ebfaee272bb 29500-0241 HUMAN OTC DRUG Oil Free Foaming Facial Cleanser TRICLOSAN LIQUID TOPICAL 20100524 OTC MONOGRAPH NOT FINAL part333 Personal Care Products, Inc. TRICLOSAN .25 mL/100mL 29500-0819_aa6d87e0-cfa1-4cc0-af22-0036fca25bfd 29500-0819 HUMAN OTC DRUG ADVANCED FLUORIDE ANTICAVITY SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110124 OTC MONOGRAPH FINAL part355 Personal Care Products, LLC SODIUM MONOFLUOROPHOSPHATE .76 g/100g 29500-0864_ee564657-d6de-4e42-84c8-4492e5296389 29500-0864 HUMAN OTC DRUG Personal Care Creamy Petroleum Jelly PETROLATUM CREAM TOPICAL 20110107 OTC MONOGRAPH FINAL part347 PERSONAL CARE PRODUCTS, LLC PETROLATUM 30 g/100g 29500-0881_18b9ce7f-e389-419b-b6db-feb9b5a15ec9 29500-0881 HUMAN OTC DRUG Personal Care Antibacterial Foaming Hand Wash TRICLOSAN LIQUID TOPICAL 20110107 OTC MONOGRAPH FINAL part333E Personal Care Products, LLC TRICLOSAN .4 mL/100mL 29500-1000_dfd252c8-306f-4bc2-ba7e-9116d27c8b77 29500-1000 HUMAN OTC DRUG Personal Care Alcohol, Benzethonium Chloride KIT 20091101 OTC MONOGRAPH NOT FINAL part333 Personal Care Products, Inc. 29500-2113_d50e08a4-02d9-4f2e-a95d-7caf4e323bde 29500-2113 HUMAN OTC DRUG Personal Care Creamy Petroleum Jelly PETROLATUM CREAM TOPICAL 20110107 OTC MONOGRAPH FINAL part347 PERSONAL CARE PRODUCTS, LLC PETROLATUM 30 g/100g 29500-2216_00e9e38c-1233-4490-9846-cb641b01420a 29500-2216 HUMAN OTC DRUG Personal Care Pyrithione Zinc Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20110107 OTC MONOGRAPH FINAL part358H Personal Care Products, LLC PYRITHIONE ZINC 4.04 g/400mL 29500-2224_47b37f46-1f79-48d9-a884-658056177af4 29500-2224 HUMAN OTC DRUG Creamy Cocoa Butter Petroleum Jelly PETROLATUM CREAM TOPICAL 20110119 OTC MONOGRAPH FINAL part347 Personal Care Products, LLC PETROLATUM 30 g/100g 29500-2238_7bd2de97-4d53-4bc1-9e59-f7e94ae892d9 29500-2238 HUMAN OTC DRUG Advanced Whitening Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110124 OTC MONOGRAPH FINAL part355 Personal Care Products, LLC SODIUM MONOFLUOROPHOSPHATE .76 g/100g 29500-2264_23d313be-ba42-4b43-985f-9cade1dfa274 29500-2264 HUMAN OTC DRUG Vagi care Benzocaine, benzalkonium chloride CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Personal Care Products BENZALKONIUM CHLORIDE; BENZOCAINE .003; 1.05 g/21g; g/21g 29500-2278_e20a0550-a963-4275-828e-bf41d30374eb 29500-2278 HUMAN OTC DRUG Personal Care Ice Cold Menthol GEL TOPICAL 20100604 OTC MONOGRAPH FINAL part348 Personal Care Products, Inc. MENTHOL 1 g/100g 29500-2433_8d9b88cc-7bb7-4532-9a07-201713581ea0 29500-2433 HUMAN OTC DRUG Muscle Rub Ultra Strength Pain Relieving MENTHOL CREAM TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part348 Personal Care Products, Inc. MENTHOL 1.05 g/42g 29500-2434_69c15fdd-eaf7-480c-a1b1-847830f9c47f 29500-2434 HUMAN OTC DRUG Jock Itch Antifungal CLOTRIMAZOLE CREAM TOPICAL 20130710 OTC MONOGRAPH FINAL part333C Personal Care Products, Inc. CLOTRIMAZOLE 420 mg/42g 29500-2435_485c5449-83f7-4988-bac9-ea4fd3745fed 29500-2435 HUMAN OTC DRUG Athletes Foot Antifungal Antifungal CLOTRIMAZOLE CREAM TOPICAL 20130710 OTC MONOGRAPH FINAL part333C Personal Care Products, Inc. CLOTRIMAZOLE 350 mg/35g 29500-2436_629d8eeb-d02d-4c7d-87e6-40542a82d989 29500-2436 HUMAN OTC DRUG Triple Antibiotic Extra Strength BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE OINTMENT TOPICAL 20130710 OTC MONOGRAPH FINAL part333B Personal Care Products, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/9.4g; mg/9.4g; [iU]/9.4g 29500-2437_69bf5fe2-9930-4fbb-a2d0-6a61f46dbfbf 29500-2437 HUMAN OTC DRUG Anti-Itch Extra Strength DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part348 Personal Care Products, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 700; 35 mg/35g; mg/35g 29500-2438_2c095063-30f4-4aba-8ffd-ccd2deab02a8 29500-2438 HUMAN OTC DRUG Anesthetic Hemorrhoidal With Aloe PRAMOXINE HYDROCHLORIDE, ZINC OXIDE OINTMENT TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part347 Personal Care Products, Inc. PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 420; 5.25 mg/42g; g/42g 29500-2439_328f2e5f-41e1-474e-8f3a-e44281048e61 29500-2439 HUMAN OTC DRUG Hydrocortisone Ultra Strength HYDROCORTISONE CREAM TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part348 Personal Care Products, Inc. HYDROCORTISONE 140 mg/14g 29500-6000_b51ea9b3-01d9-41a2-b73d-fa334d7cfc28 29500-6000 HUMAN OTC DRUG Personal Care Pyrithione Zinc Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20100122 OTC MONOGRAPH FINAL part358 Personal Care Products, Inc. PYRITHIONE ZINC 1 mL/100mL 29500-7000_ba6c88c0-fbcf-4e3a-8ec4-49b67b63eb48 29500-7000 HUMAN OTC DRUG Personal Care Sensitive Skin Deep Cleaning Astringent SALICYLIC ACID LIQUID TOPICAL 20100120 OTC MONOGRAPH NOT FINAL part333D Personal Care Products, LLC SALICYLIC ACID .5 mL/100mL 29500-7010_8ef2c353-ec28-4551-ae58-e724056e8518 29500-7010 HUMAN OTC DRUG Personal Care Oil Free Foaming Facial Cleanser TRICLOSAN LIQUID TOPICAL 20100120 OTC MONOGRAPH NOT FINAL part333A Personal Care Products, Inc TRICLOSAN .25 mL/100mL 29500-7020_987eb72d-5dc7-462a-aa42-f9a0da6a9b03 29500-7020 HUMAN OTC DRUG Personal Care Oil-Free Acne Wash SALICYLIC ACID LIQUID TOPICAL 20100120 OTC MONOGRAPH FINAL part358H Personal Care Products, Inc SALICYLIC ACID 2 mL/100mL 29500-7820_8ab3ce88-2742-4126-8600-5aed16d490d5 29500-7820 HUMAN OTC DRUG Vagicaine BENZOCAINE, RESORCINOL CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part348 Personal Care Products, Inc. BENZOCAINE; RESORCINOL 5.67; .85 g/28g; g/28g 29500-8010_8af960fe-20ef-4f21-ac98-1d768e2b2665 29500-8010 HUMAN OTC DRUG Personal Care Petroleum petrolatum JELLY TOPICAL 20120701 OTC MONOGRAPH FINAL part346 PERSONAL CARE PRODUCTS PETROLATUM 170 g/170g 29500-8020_31720587-a37f-4a21-b4a0-d8e98a3a0d9d 29500-8020 HUMAN OTC DRUG Personal Care Petroleum petrolatum JELLY TOPICAL 20120701 OTC MONOGRAPH FINAL part346 Personal Care Products PETROLATUM 100 g/100g 29500-8030_90036340-e1e3-428f-8a09-632cf3b31a7a 29500-8030 HUMAN OTC DRUG Personal Care Petroleum petrolatum JELLY TOPICAL 20120701 OTC MONOGRAPH FINAL part346 Personal Care Products PETROLATUM 170 g/170g 29500-8040_4746fdd0-b393-491c-aaa1-9517c2ecf53c 29500-8040 HUMAN OTC DRUG Petroleum Petrolatum JELLY TOPICAL 20120701 OTC MONOGRAPH FINAL part346 Personal Care Products PETROLATUM 99.9 g/100g 29500-8050_2292397c-27b5-4a21-9b18-1412a9978a81 29500-8050 HUMAN OTC DRUG Personal Care Products petroleum petrolatum JELLY TOPICAL 20120629 OTC MONOGRAPH FINAL part346 Personal Care Products PETROLATUM 1 g/g 29500-8050_5c4923fd-29b1-4fff-b52c-28249dd39fa1 29500-8050 HUMAN OTC DRUG Personal Care Petroleum petrolatum JELLY TOPICAL 20120701 OTC MONOGRAPH FINAL part346 PERSONAL CARE PRODUCTS PETROLATUM 100 g/100g 29500-8060_f683473c-a4f5-411c-9855-2a9cb90127cb 29500-8060 HUMAN OTC DRUG Personal Care Petroleum Jelly Skin Protectant White Petroleum GEL TOPICAL 20100325 OTC MONOGRAPH FINAL part347 Personal Care Products, Inc PETROLATUM 100 g/g 29500-903_9fc68949-3cb7-4c68-893d-3408a9501a31 29500-903 HUMAN OTC DRUG Antibacterial triclosan SOAP TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC TRICLOSAN .888 mL/444mL 29500-9033_163dd1a2-964c-4184-82e2-7f965d81714b 29500-9033 HUMAN OTC DRUG Vaporizing Chest camphor, menthol, eucalyptus SALVE TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part348 Personal Care Products CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 5.31; 1.13; 1.13 g/113g; g/113g; g/113g 29500-9034_ce7d5be7-57b3-41d3-a591-5483cab4fbf9 29500-9034 HUMAN OTC DRUG Ice Cold Analgesic Menthol GEL TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part348 Personal Care Products MENTHOL 2.27 g/227g 29500-9038_eec8fc4f-bd64-4832-8db4-4ed6b7d1b231 29500-9038 HUMAN OTC DRUG Personal Care Antibacterial Hand TRICLOSAN SOAP TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part333E Personal Care Products, LLC TRICLOSAN .2 mL/100mL 29500-907_84ac8936-94ff-4305-ad67-db6efa592bdc 29500-907 HUMAN OTC DRUG hand triclosan SOAP TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part333A Personal Care Products TRICLOSAN .888 mL/444mL 29500-907_8f44f0a7-16a2-42ae-83ad-5f6ca7ae7f1a 29500-907 HUMAN OTC DRUG hand triclosan SOAP TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part333A Personal Care Products TRICLOSAN .888 mL/444mL 29500-9077_4fea0c74-56e5-4c6c-9537-950c02b40db2 29500-9077 HUMAN OTC DRUG Personal Care Antibacterial Hand - Raspberry TRICLOSAN SOAP TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part333E Personal Care Products, LLC TRICLOSAN .2 mL/100mL 29500-9077_baceb0f2-d7f2-4bc6-9a89-bb91099e1bc1 29500-9077 HUMAN OTC DRUG antibacterial hand triclosan SOAP TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part333A Personal Care Products TRICLOSAN .886 mL/443mL 29500-9078_e2865416-b02d-41bc-9daf-b545d1263d9b 29500-9078 HUMAN OTC DRUG Personal Care Antibacterial Hand - Fresh Peach TRICLOSAN SOAP TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part333E Personal Care Products, LLC TRICLOSAN .2 mL/100mL 29500-9079_46b8352a-6179-4f57-bb48-a37aca3a223f 29500-9079 HUMAN OTC DRUG Personal Care Antibacterial Hand - Fresh Melon TRICLOSAN SOAP TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part333E Personal Care Products, LLC TRICLOSAN .2 mL/100mL 29500-908_438135cc-9c07-4056-bf33-9d30694af2fd 29500-908 HUMAN OTC DRUG Wet Wipes benzethonium chloride CLOTH TOPICAL 20110803 OTC MONOGRAPH NOT FINAL part333A Personal Care Products BENZETHONIUM CHLORIDE .009 g/3g 29500-9080_d99c4926-aa77-4e34-946b-b0de77300541 29500-9080 HUMAN OTC DRUG Personal Care alcohol GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333A Personal Care Products, Inc. ALCOHOL .62 mL/mL 29500-9083_a5d0297b-7c72-40df-a650-2eca0117dab2 29500-9083 HUMAN OTC DRUG PERSONAL CARE EXTRA STRENGTH COLD HOT MENTHOL PATCH TOPICAL 20110920 OTC MONOGRAPH NOT FINAL part348 PERSONAL CARE PRODUCTS, LLC MENTHOL 50 mg/1 29500-9085_44fb2879-50e7-4501-a3ba-3aa055ef21f9 29500-9085 HUMAN OTC DRUG Hand Sanitizer ethyl alcohol GEL TOPICAL 20120120 OTC MONOGRAPH NOT FINAL part333A Personal Care Products ALCOHOL 9.3 mL/60mL 29500-9085_48eca6ed-5470-4e21-ab6e-3ecf598229bb 29500-9085 HUMAN OTC DRUG Personal Care Hand Sanitizer ALCOHOL GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333A Personal Care Products, Inc. ALCOHOL .62 mL/mL 29500-9086_5dfc161b-2aab-41cd-8295-0ed3568e2dde 29500-9086 HUMAN OTC DRUG Instant Hand Sanitizer and Moisterizer Ethyl alcohol LIQUID TOPICAL 20111114 OTC MONOGRAPH NOT FINAL part333A Personal Care Products ALCOHOL 146 mL/236mL 29500-9087_b635599f-bbdc-4b33-ae77-9d4b761669b8 29500-9087 HUMAN OTC DRUG Powerhouse Fresh Scent Ultra Dish Triclosan SOAP TOPICAL 20111219 OTC MONOGRAPH NOT FINAL part333A Personal Care Products TRICLOSAN .562 mL/562mL 29500-9088_f4d8069c-dfdc-4f2a-b0fc-76f61eef85b0 29500-9088 HUMAN OTC DRUG Hand Sanitizer benzalkonium chloride AEROSOL, FOAM TOPICAL 20110705 OTC MONOGRAPH NOT FINAL part333A Personal Care Products BENZALKONIUM CHLORIDE .27 mL/207mL 29500-909_1ee5fe86-8677-4380-bfcb-7fa1c55a7202 29500-909 HUMAN OTC DRUG Hand Sanitizer alcohol GEL TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333A Personal Care Products ALCOHOL 146.3 mL/236mL 29500-9090_deed0020-4c72-499b-90f4-8b8b3bd68ef8 29500-9090 HUMAN OTC DRUG Personal Care Medicated Body Powder POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part348 Personal Care Products, Inc. MENTHOL; ZINC OXIDE 3; 20 mg/2g; mg/2g 29500-9091_81b6c114-1bac-49de-a7db-cf436fec662a 29500-9091 HUMAN OTC DRUG Personal Care Medicated Foot Powder POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part348 Personal Care Products, Inc. MENTHOL 20 mg/2g 29500-910_984705b1-d7e6-4f4f-b090-e4c4e8d6b521 29500-910 HUMAN OTC DRUG Hand Sanitizer alcohol GEL TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333A Personal Care Products ALCOHOL 184.6 mL/355mL 29500-9208_ec7f2d22-ffc3-4609-b8dc-20934afe30c5 29500-9208 HUMAN OTC DRUG Personal Care Antibacterial Triclocarben SOAP TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC TRICLOCARBAN .67 g/86g 29500-9210_107b0b4d-ea99-464d-aea7-40dfbfaa9e0e 29500-9210 HUMAN OTC DRUG Solid anti perspirant aluminum chlorohydrate CREAM TOPICAL 20110727 OTC MONOGRAPH FINAL part350 Personal Care Products ALUMINUM CHLOROHYDRATE 11.4 g/57g 29500-9211_74bb0f48-d370-43d0-ad93-ad63ebac61fe 29500-9211 HUMAN OTC DRUG Ultra dry antiperspirant aluminum chlorhydrate CREAM TOPICAL 20110727 OTC MONOGRAPH FINAL part350 Personal Care Products ALUMINUM CHLOROHYDRATE 11.4 g/57g 29500-9280_030c6510-ba89-436b-af32-203199179002 29500-9280 HUMAN OTC DRUG Personal Care Hand Sanitizer Aloe ALCOHOL GEL TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part333 Personal Care Products, Inc. ALCOHOL 62 mL/100mL 29500-9710_ef72c22a-4027-44d7-887f-69ebe37ca00f 29500-9710 HUMAN OTC DRUG Touch Free Hand benzethonium chloride SOAP TOPICAL 20110728 OTC MONOGRAPH NOT FINAL part333A Personal Care Products BENZETHONIUM CHLORIDE .33 mL/251mL 29500-9711_72e329f5-20f9-4cfc-99e2-a24b393a34ee 29500-9711 HUMAN OTC DRUG Touch Free Hand benzethonium chloride SOAP TOPICAL 20110729 OTC MONOGRAPH NOT FINAL part333A Personal Care Products BENZETHONIUM CHLORIDE .33 mL/251mL 29500-9804_6b2c2f82-88cb-4693-8c67-0652aad15862 29500-9804 HUMAN OTC DRUG Personal Care Therapeutic T Plus Gel COAL TAR SHAMPOO TOPICAL 20100303 OTC MONOGRAPH FINAL part358H Personal Care Products COAL TAR .5 g/100mL 29565-200_3fa25193-21b8-440e-84e8-c8b7a175186d 29565-200 HUMAN OTC DRUG Sunscreen SPF30 Plus Broad Spectrum Zinc oxide LOTION TOPICAL 20060101 OTC MONOGRAPH FINAL part352 UV Natural International Pty Ltd ZINC OXIDE 12.9 mL/52mL 29565-300_a25e7ffa-6864-41be-bf98-7523104d1a73 29565-300 HUMAN OTC DRUG Sunscreen Baby SPF30 Plus Broad Spectrum Zinc oxide LOTION TOPICAL 20060101 OTC MONOGRAPH FINAL part352 UV Natural International Pty Ltd ZINC OXIDE 12.9 mL/52mL 29565-400_0cb2033f-d54f-4b90-9c62-6f64c12eb163 29565-400 HUMAN OTC DRUG Sunscreen Sport SPF30 Plus Broad Spectrum Zinc oxide LOTION TOPICAL 20060101 OTC MONOGRAPH FINAL part352 UV Natural International Pty Ltd ZINC OXIDE 32.3 mL/130mL 29565-500_1984c790-e826-41a0-a8c3-1b666b84a2db 29565-500 HUMAN OTC DRUG Sunscreen Sport Lip SPF30 Plus Broad Spectrum Zinc oxide LOTION TOPICAL 20060101 OTC MONOGRAPH FINAL part352 UV Natural International Pty Ltd ZINC OXIDE 1.24 mL/5mL 29784-100_2dc323a9-a1bd-44ed-9d94-de4fcc58d222 29784-100 HUMAN OTC DRUG PROcure Psoriapalm SALICYLIC ACID LOTION TOPICAL 20131205 OTC MONOGRAPH FINAL part358H Profoot, Inc. SALICYLIC ACID 20 mg/mL 29784-181_456a62aa-a746-4ce4-9934-baa10ad5b1e7 29784-181 HUMAN OTC DRUG ProClearz Maximum Strength Fungal Shield Brush-on Antifungal Tolnaftate LIQUID TOPICAL 20121022 OTC MONOGRAPH FINAL part333C Profoot, Inc. TOLNAFTATE 10 mg/mL 29784-189_2ed129dd-d12a-46ba-8233-710970337672 29784-189 HUMAN OTC DRUG ProClearz Maximum Strength Anti-fungal Pen Tolnaftate LIQUID TOPICAL 20121023 OTC MONOGRAPH FINAL part333C Profoot, Inc. TOLNAFTATE 10 mg/mL 29784-191_b361bf0a-9594-4dbf-9c71-c73c53cd5c3f 29784-191 HUMAN OTC DRUG ProClearz Fungi-Cide PM Tolnaftate CREAM TOPICAL 20121010 OTC MONOGRAPH FINAL part333C Profoot, Inc. TOLNAFTATE 1 g/100g 29784-413_073a9d6b-5bd9-49c4-a166-9d6741033067 29784-413 HUMAN OTC DRUG Synovium Pain Relieving Gel Capsicum Oleoresin GEL TOPICAL 20131118 OTC MONOGRAPH NOT FINAL part348 Profoot, Inc. CAPSAICIN 156.25 ng/mL 29860-002_b5cd8504-28fa-4a1a-8074-78fc20307fa6 29860-002 HUMAN OTC DRUG ANTIBACTERIAL AMBER HAND SOAP TRICLOSAN LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Ningbo United Group Import and Export Co. Ltd. TRICLOSAN .04 mL/100mL 29860-200_3f47429d-213c-4e6f-8c48-e42763589c32 29860-200 HUMAN OTC DRUG Virx Instant Hand Sanitizer GEL TOPICAL 20091101 OTC MONOGRAPH FINAL part333 Ningbo United Group Co., Ltd. ALCOHOL 215.14 mL/347mL 29860-203_57c78e9b-2171-4627-80b1-e9644c022d83 29860-203 HUMAN OTC DRUG Virx Instant Hand Sanitizer with Security Clip GEL TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Ningbo United Group Co. Ltd. ALCOHOL 74.4 mL/120mL 29860-205_733bb21f-ae49-4d01-ac0c-e8463d4b2106 29860-205 HUMAN OTC DRUG Virx Instant Hand Sanitizer GEL TOPICAL 20100201 OTC MONOGRAPH FINAL part333 Ningbo United Group Co., Ltd. ALCOHOL 146.32 mL/236mL 29860-209_47284e3e-946d-4c99-a505-dd712725da8c 29860-209 HUMAN OTC DRUG Pacific Antibaceterial Hand Soap Rose SOAP TOPICAL 20100304 OTC MONOGRAPH FINAL part333 Ningbo United TRICLOSAN 318.975 mL/2126.5mL 29860-213_d2f3a483-13db-4ccf-a8ac-b47b22b9468c 29860-213 HUMAN OTC DRUG Pacific Antibaceterial Hand Soap Rose SOAP TOPICAL 20100304 OTC MONOGRAPH FINAL part333 Ningbo United TRICLOSAN 318.975 mL/2126.5mL 29860-217_ed7ea68f-f5fc-4dec-b78f-5f9bab6c5999 29860-217 HUMAN OTC DRUG Pacific Antibaceterial Hand Soap Lavender SOAP TOPICAL 20100302 OTC MONOGRAPH FINAL part333 Ningbo United TRICLOSAN 318.975 mL/2126.5mL 29860-221_05e1b5da-19a2-4f5e-bb1e-6665838e0cfd 29860-221 HUMAN OTC DRUG Pacific Antibaceterial Hand Soap Golden Sunflower SOAP TOPICAL 20100304 OTC MONOGRAPH FINAL part333 Ningbo United TRICLOSAN 318.975 mL/2126.5mL 29943-002_8482e2bb-657c-4361-85c1-3a7341aa6091 29943-002 HUMAN OTC DRUG blink tears polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20080201 OTC MONOGRAPH FINAL part349 AMO Hangzhou Co., LTD POLYETHYLENE GLYCOL 400 2.5 mg/mL 29943-004_117f10af-354b-4371-8754-b976e0a90c10 29943-004 HUMAN OTC DRUG blink gel tears polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20080501 OTC MONOGRAPH FINAL part349 AMO Hangzhou Co., LTD POLYETHYLENE GLYCOL 400 2.5 mg/mL 29978-127_63900fab-b3fe-45fc-84a9-8ca1cd4ea798 29978-127 HUMAN OTC DRUG Capron DM Dextromethorphan HBr and Pyrilamine Maleate LIQUID ORAL 20130620 OTC MONOGRAPH FINAL part341 Capital Pharmaceutical, LLC DEXTROMETHORPHAN HYDROBROMIDE; PYRILAMINE MALEATE 7.5; 7.5 mg/5mL; mg/5mL 29978-420_d73cec86-e710-4d93-b81b-28d10707164b 29978-420 HUMAN OTC DRUG CapCof Codeine Phosphate, Phenylephrine Hydrochloride, Chlorpheniramine Maleate LIQUID ORAL 20101008 OTC MONOGRAPH FINAL part341 Capital Pharmaceutical, LLC CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/5mL; mg/5mL; mg/5mL CV 29978-601_f1610d30-0f88-41fd-b2ba-901d280af34a 29978-601 HUMAN OTC DRUG Capmist DM Dextromethorphan Hydrobromide, Guaifenesin and Pseudoephedrine Hydrochloride TABLET ORAL 20130620 OTC MONOGRAPH FINAL part341 Capital Pharmaceutical, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 15; 400; 60 mg/1; mg/1; mg/1 29978-606_7b3ee236-d486-4723-833f-205a281f8fb7 29978-606 HUMAN OTC DRUG CAPMIST DM Dextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride TABLET ORAL 20110727 OTC MONOGRAPH FINAL part341 Capital Pharmaceutical DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 30; 400; 30 mg/1; mg/1; mg/1 29991-505_999446b3-64c8-48a8-8505-48ec151f795d 29991-505 HUMAN OTC DRUG KSS CLEAN HANDS ANTISEPTIC CLEANER Chloroxylenol LIQUID TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333 KSS Enterprises CHLOROXYLENOL 10.22 g/1000mL 30014-003_82d709e0-63ca-11e1-aaf7-0002a5d5c51b 30014-003 HUMAN OTC DRUG Monistat 7 Combination Pack Triple Action Miconazole Nitrate KIT 20100410 NDA NDA017450 McNeil, PPC, Inc. 30014-016_0ad6ee0b-00d0-4d20-89ff-1c4168373f30 30014-016 HUMAN OTC DRUG Monistat 3 Combination Pack Miconazole Nitrate KIT 20091210 NDA NDA020670 McNeil-PPC, Inc. 30014-018_23b87364-45ad-45e3-b872-2b078b1ff2e8 30014-018 HUMAN OTC DRUG Monistat 3 Combination Pack Miconazole Nitrate KIT 20091210 NDA NDA020670 McNeil-PPC, Inc. 30014-023_26fdcd20-63c5-11e1-9282-0002a5d5c51b 30014-023 HUMAN OTC DRUG Monistat 7 Combination Pack 7-Day Pre-Filled Applicators Miconazole Nitrate KIT 20111015 NDA NDA017450 McNEIL-PPC, Inc. 30014-100_158853b8-9c86-426d-8790-5eb8d5d20056 30014-100 HUMAN OTC DRUG Tucks Hemorrhoidal Mineral Oil, Pramoxine Hydrochloride, and Zinc Oxide OINTMENT TOPICAL 20120730 OTC MONOGRAPH NOT FINAL part346 McNEIL-PPC, Inc. MINERAL OIL; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 466; 10; 125 mg/g; mg/g; mg/g 30014-102_5562f4e9-82c9-4678-b476-fe0682eb6bd8 30014-102 HUMAN OTC DRUG Tucks Medicated Cooling Pads Witch Hazel CLOTH TOPICAL 20120730 OTC MONOGRAPH FINAL part346 McNEIL-PPC, Inc. WITCH HAZEL 500 mg/1 30014-103_5d70d3bd-5ad0-4d95-adac-c518815d32ed 30014-103 HUMAN OTC DRUG Tucks Internal Soothers Hemorrhoidal STARCH, CORN SUPPOSITORY RECTAL 20120806 OTC MONOGRAPH FINAL part346 McNEIL-PPC, Inc. STARCH, CORN 510 mg/1 30014-104_163ec179-7887-43aa-8ada-b6cfeb86f03f 30014-104 HUMAN OTC DRUG Tucks Take Alongs Towelettes Witch Hazel CLOTH TOPICAL 20120730 OTC MONOGRAPH FINAL part346 McNEIL-PPC, Inc. WITCH HAZEL 500 mg/1 30056-002_1e5df8c8-14d6-4e52-8ccc-4294da7e1962 30056-002 HUMAN OTC DRUG Sani-Kleen Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part333A Eco-Logics, Inc. ALCOHOL 620 mL/L 30056-004_3e029a9a-1275-4373-9f97-af9fa3c5498c 30056-004 HUMAN OTC DRUG Elgin Pain Relief Menthol GEL TOPICAL 20091215 OTC MONOGRAPH NOT FINAL part348 Eco-Logics, Inc. MENTHOL 35 mg/g 30056-005_10e7a76a-f3cc-4da7-bf7a-49f808c3f564 30056-005 HUMAN OTC DRUG Elgin Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part347 Eco-Logics, Inc. ALCOHOL 620 mg/g 30056-006_0c7b08ae-7b24-4f32-bb80-e5205c28097b 30056-006 HUMAN OTC DRUG Advanced Healing Diabetic Skin Care Dimethicone LOTION TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part347 Eco-Logics, Inc. DIMETHICONE 10 mg/g 30056-007_1fdfaf71-3d1d-4512-8070-25a49b229d05 30056-007 HUMAN OTC DRUG Therapeutic Herbal Muscle Calm Capsicum Capsicum LOTION TOPICAL 20100615 OTC MONOGRAPH NOT FINAL part348 Eco-Logics, Inc. CAPSICUM .25 mg/g 30142-001_7ec6f45d-1f37-4f06-afb1-505714ec723e 30142-001 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20110112 OTC MONOGRAPH FINAL part333D Kroger co SALICYLIC ACID 19.8 mg/g 30142-002_1f2a582f-4f1b-45c7-8454-795081aed123 30142-002 HUMAN OTC DRUG enema Saline ENEMA RECTAL 20091107 OTC MONOGRAPH NOT FINAL part334 Kroger Company SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 30142-003_79b5a2df-319b-4240-be2f-60b6cfad37b5 30142-003 HUMAN OTC DRUG Stool Softener plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20100715 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 30142-004_0192b11a-4819-49f8-8f1a-b9b524adc76d 30142-004 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20130118 OTC MONOGRAPH FINAL part355 Kroger Co SODIUM FLUORIDE 10.4 mg/mL 30142-005_2da7c91c-eba2-4537-9f0f-a1f1c9d36946 30142-005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 Kroger Company SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 30142-006_52d7dfad-402f-48d2-9849-8b1c6067661e 30142-006 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090603 OTC MONOGRAPH FINAL part333 Kroger ISOPROPYL ALCOHOL 50 mL/100mL 30142-007_3809bdce-1adf-4a90-9b66-8b79bce19fc7 30142-007 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090110 OTC MONOGRAPH FINAL part333 Kroger ISOPROPYL ALCOHOL 70 mL/100mL 30142-008_963b380f-7d86-45e0-9822-8a0e739b50ed 30142-008 HUMAN OTC DRUG pain relief concentrated infants Acetaminophen SUSPENSION/ DROPS ORAL 19870715 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 80 mg/.8mL 30142-009_ef8c23e4-39ae-42e0-bbdd-f5300c1a7a42 30142-009 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE ORAL 20100824 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. DOCUSATE SODIUM 100 mg/1 30142-012_33bec136-9168-c872-5a8d-f097c5e20bf9 30142-012 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium 20.6mg Capsules CAPSULE, DELAYED RELEASE ORAL 20140317 ANDA ANDA078878 The Kroger Co. OMEPRAZOLE MAGNESIUM 20 mg/1 30142-013_e27304da-de30-4eda-9025-39672d7b55a7 30142-013 HUMAN OTC DRUG Allergy and congestion relief Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120406 ANDA ANDA076050 Kroger Company LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 30142-014_2ef6229a-89bf-4b7b-8159-06ac2ddd050b 30142-014 HUMAN OTC DRUG Laxative pills Maximum Strength Sennosides TABLET ORAL 20130616 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. SENNOSIDES 25 mg/1 30142-015_acb39297-4c50-41db-b10d-574405edd19b 30142-015 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 19900815 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL 30142-016_485e77ce-dd87-4d4a-bfb6-20896952b4b0 30142-016 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090223 OTC MONOGRAPH FINAL part335 Kroger BISMUTH SUBSALICYLATE 262 mg/15mL 30142-019_669e8a0c-a33e-43dd-944c-2eff4df15c50 30142-019 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120901 ANDA ANDA202727 The Kroger Co. LANSOPRAZOLE 15 mg/1 30142-022_79fcf985-483e-45b7-a907-0087afc34631 30142-022 HUMAN OTC DRUG Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20130701 OTC MONOGRAPH FINAL part347 Krogers LANOLIN; PETROLATUM 133; 459 mg/g; mg/g 30142-024_884670a6-f1b6-4bf4-921a-976015c746af 30142-024 HUMAN OTC DRUG Peptic Relief Maximum Strength BISMUTH SUBSALICYLATE SUSPENSION ORAL 20090223 OTC MONOGRAPH FINAL part341 Kroger BISMUTH SUBSALICYLATE 525 mg/15mL 30142-027_6f8b0cc6-1b30-4c2f-99be-ec8d34fc82d9 30142-027 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET ORAL 20130308 OTC MONOGRAPH NOT FINAL part343 The Kroger Co. ASPIRIN 81 mg/1 30142-029_493124ad-9e0f-4c01-b66d-131e382ca210 30142-029 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20051215 ANDA ANDA076775 Kroger Company NICOTINE 2 mg/1 30142-041_12e64877-b0ad-491a-927c-395dee0b08d3 30142-041 HUMAN OTC DRUG Nite Time Cold and Flu Relief acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20060405 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 30142-044_9cb9fb12-ed46-42eb-9241-f61582d33de6 30142-044 HUMAN OTC DRUG Acetaminophen PM Acetaminophen, Diphenhydramine HCl CAPSULE, COATED ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 30142-046_7d9287b9-e4e3-442a-9696-0f7850141b5f 30142-046 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET, COATED ORAL 20090804 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 500 mg/1 30142-047_eba27332-dd91-4f83-9542-42ba7b8a4b84 30142-047 HUMAN OTC DRUG heartburn relief Ranitidine TABLET ORAL 20080225 ANDA ANDA078653 Kroger Company RANITIDINE HYDROCHLORIDE 150 mg/1 30142-049_301cbf6c-4584-420f-83f5-bcd55272e71c 30142-049 HUMAN OTC DRUG muscle rub non greasy pain relieving Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part348 Kroger Company CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g 30142-050_f131cad7-bf84-4c2a-b56b-3b6efaa01142 30142-050 HUMAN OTC DRUG ibuprofen pm diphenhydramine citrate and ibuprofen TABLET, COATED ORAL 20090406 ANDA ANDA079113 Kroger Company DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 30142-054_7536543a-e4ec-4143-abb6-6b1093a221f5 30142-054 HUMAN OTC DRUG 12 hour decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19991214 ANDA ANDA075153 Kroger Company PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 30142-055_783e1ad5-3a7e-4291-b63f-99898b00d981 30142-055 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20141109 ANDA ANDA091353 The Kroger Co. NAPROXEN SODIUM 220 mg/1 30142-056_17b11026-34c0-4312-b060-800c51ac9e7d 30142-056 HUMAN OTC DRUG Nite Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140621 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 30142-057_a5d0c5f7-3709-4699-800c-ee45fd68baee 30142-057 HUMAN OTC DRUG ibuprofen infants ibuprofen SUSPENSION ORAL 20021120 ANDA ANDA075217 Kroger Company IBUPROFEN 50 mg/1.25mL 30142-061_d1394a26-b4f0-42a1-839d-5665a1211fc6 30142-061 HUMAN OTC DRUG Allergy Relief fexofenadine hcl TABLET, FILM COATED ORAL 20110416 ANDA ANDA076447 Kroger Company FEXOFENADINE HYDROCHLORIDE 180 mg/1 30142-065_b1a01410-f97b-4ad5-b307-ad48b42cf52e 30142-065 HUMAN OTC DRUG nasal extra moisturizing Oxymetazoline HCl SPRAY NASAL 19940617 OTC MONOGRAPH FINAL part341 Kroger Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 30142-069_cf007b4e-4782-4dbf-9a76-b8d50ef4abdc 30142-069 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 19890715 OTC MONOGRAPH FINAL part347 Kroger Co PETROLATUM 1 g/g 30142-070_97de57b2-9753-47b9-b2c3-974166406d00 30142-070 HUMAN OTC DRUG Antacid calcium carbonate TABLET ORAL 20101018 20190228 OTC MONOGRAPH FINAL part331 The Kroger Co. CALCIUM CARBONATE 500 mg/1 30142-071_97de57b2-9753-47b9-b2c3-974166406d00 30142-071 HUMAN OTC DRUG Antacid calcium carbonate TABLET ORAL 20101018 20190228 OTC MONOGRAPH FINAL part331 The Kroger Co. CALCIUM CARBONATE 500 mg/1 30142-072_5262b7e6-1e9a-4c1d-93dc-5b79f38a8e5c 30142-072 HUMAN OTC DRUG Mouth Rinse EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL MOUTHWASH ORAL 19891111 OTC MONOGRAPH NOT FINAL part356 Kroger EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 30142-074_946c573d-8d3f-425d-b468-a01ec93fa56b 30142-074 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 20060311 ANDA ANDA077349 Kroger Company IBUPROFEN 200 mg/1 30142-076_97de57b2-9753-47b9-b2c3-974166406d00 30142-076 HUMAN OTC DRUG Antacid calcium carbonate TABLET ORAL 20101018 20190228 OTC MONOGRAPH FINAL part331 The Kroger Co. CALCIUM CARBONATE 750 mg/1 30142-078_9439f31a-8585-48e7-8b63-ac8621c244ce 30142-078 HUMAN OTC DRUG Castor Oil Castor Oil LIQUID ORAL 20010419 OTC MONOGRAPH NOT FINAL part334 Kroger Co CASTOR OIL 1 g/mL 30142-079_0c04fed8-6cb0-4ff2-bb5d-5baa4bf4d2af 30142-079 HUMAN OTC DRUG KROGER WATERLESS HAND SANITIZER WITH ALOE ETHYL ALCOHOL LIQUID TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY ALCOHOL 700 mg/mL 30142-079_3c4e13ad-750b-4236-a148-26995b35965d 30142-079 HUMAN OTC DRUG KROGER WATERLESS HAND SANITIZER WITH ALOE ETHYL ALCOHOL LIQUID TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY ALCOHOL 700 mg/mL 30142-080_dc1c99c4-3f5b-4a8c-91b1-d5ab56cb0d1c 30142-080 HUMAN OTC DRUG Kroger Antifungal Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Kroger Company TERBINAFINE HYDROCHLORIDE 1 g/100g 30142-081_063153cc-00fd-4390-bc68-90b21203678a 30142-081 HUMAN OTC DRUG miconazole 3 Miconazole nitrate KIT 20000223 ANDA ANDA075329 Kroger Company 30142-082_68fd1c76-32a4-4225-a814-57d6ac31573b 30142-082 HUMAN OTC DRUG Antibiotic Plus Pain Relief Neomycin, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20080708 OTC MONOGRAPH NOT FINAL part347 Kroger Company NEOMYCIN; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 30142-083_da96fcc0-e1e6-428e-bf07-be04711bb43c 30142-083 HUMAN OTC DRUG ibuprofen cold and sinus Ibuprofen, Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011012 ANDA ANDA074567 Kroger Company IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 30142-085_af7e41bc-29be-4049-8310-fe0a455f7e9f 30142-085 HUMAN OTC DRUG Allergy Relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Kroger Company LORATADINE 5 mg/5mL 30142-090_37a8062e-4a8c-4c2d-87c4-1194b120a281 30142-090 HUMAN OTC DRUG DayTime Nite Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20070831 OTC MONOGRAPH FINAL part341 Kroger Company 30142-090_df8de516-bbf8-493c-ba50-9a918df730fe 30142-090 HUMAN OTC DRUG daytime nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110216 OTC MONOGRAPH FINAL part341 Kroger Company 30142-090_e002dcf1-5a4d-4412-9c51-5b2078a711fa 30142-090 HUMAN OTC DRUG NITE TIME DAYTIME MULTI SYMPTOM COLD/FLU Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130813 OTC MONOGRAPH FINAL part341 Kroger Company 30142-092_83c49382-642f-494f-b784-e4513b2c3bbf 30142-092 HUMAN OTC DRUG Childrens Non-Drowsy Allergy Relief 24-Hour Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Kroger Company LORATADINE 5 mg/5mL 30142-094_d33311f3-da82-4619-9381-f3201d8a97fa 30142-094 HUMAN OTC DRUG nasal decongestant pe non drowsy maximum strength Phenylephrine Hydrochloride TABLET ORAL 20050812 OTC MONOGRAPH FINAL part341 Kroger Company PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 30142-096_bd85e0eb-a252-4693-9d2f-ca7304c35abd 30142-096 HUMAN OTC DRUG flu and severe cold and cough daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20120117 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 30142-098_b6197754-3cca-42b2-9f31-9585c48f5394 30142-098 HUMAN OTC DRUG Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20140315 NDA NDA021920 Kroger Company NAPROXEN SODIUM 220 mg/1 30142-100_362cf25e-3a84-4957-831b-1b1bb52597b9 30142-100 HUMAN OTC DRUG acetaminophen Acetaminophen TABLET, COATED ORAL 20140401 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 500 mg/1 30142-102_db27dfd4-3100-49ea-a268-e6db694d5e24 30142-102 HUMAN OTC DRUG Childrens All Day Allergy Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Kroger Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 30142-103_ff27b735-85a3-4b38-98b3-b8a0d64efbfe 30142-103 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20110830 OTC MONOGRAPH NOT FINAL part343 The Kroger Co. ASPIRIN 81 mg/1 30142-104_aed620ff-565b-488a-bcc6-04d31842f76e 30142-104 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20140630 OTC MONOGRAPH NOT FINAL part343 The Kroger Co. ASPIRIN 81 mg/1 30142-105_74d6a62b-72b0-4248-85ee-be8f89f06e4a 30142-105 HUMAN OTC DRUG Pain Relief Childrens Acetaminophen SUSPENSION ORAL 20001214 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL 30142-106_d6b4919d-21fa-41bb-ac8e-cf7c70a41104 30142-106 HUMAN OTC DRUG Childrens All Day Allergy Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Kroger Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 30142-107_74c52457-0992-4c3f-9227-272bd9d896a1 30142-107 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20100706 OTC MONOGRAPH FINAL part341 The Kroger Co. GUAIFENESIN 400 mg/1 30142-109_440cc9d4-81f6-4dd5-8277-9c3faed4df11 30142-109 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan Hydrobromide and Guaifenesin TABLET, COATED ORAL 20100102 OTC MONOGRAPH FINAL part341 The Kroger Co. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 30142-110_8c619728-0893-4276-86df-3426ea9189d2 30142-110 HUMAN OTC DRUG stool softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100712 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. DOCUSATE SODIUM 100 mg/1 30142-111_7d20996f-f241-444b-91e0-b31ef4d0d542 30142-111 HUMAN OTC DRUG Oral Saline Laxative Ginger Lemon dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20120831 OTC MONOGRAPH NOT FINAL part334 The Kroger Company SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 2.7; 7.2 g/15mL; g/15mL 30142-112_38d477d7-97fb-41df-a2da-541ec02e270b 30142-112 HUMAN OTC DRUG Kroger DayTime Flu plus Severe Cold and Cough Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 30142-113_649cc680-4e30-4062-ac5f-78a79cc0368f 30142-113 HUMAN OTC DRUG Kroger NiteTime Flu plus Severe Cold and Cough Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 30142-117_c21b70b0-f45f-4a3b-8e26-38b24a16e919 30142-117 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 Kroger Company LANSOPRAZOLE 15 mg/1 30142-118_97de57b2-9753-47b9-b2c3-974166406d00 30142-118 HUMAN OTC DRUG Antacid calcium carbonate TABLET ORAL 20101018 20190131 OTC MONOGRAPH FINAL part331 The Kroger Co. CALCIUM CARBONATE 1000 mg/1 30142-120_e6ab3da6-8962-479b-ba46-ac88594d7e52 30142-120 HUMAN OTC DRUG womens laxative Bisacodyl TABLET, COATED ORAL 20110520 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. BISACODYL 5 mg/1 30142-121_ddd60389-5783-43cc-8734-5b2c6546d5a0 30142-121 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120511 ANDA ANDA202300 The Kroger Co IBUPROFEN 200 mg/1 30142-122_908222a8-1a7a-4322-ae08-c43042551f3d 30142-122 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120712 ANDA ANDA202300 The Kroger Co. IBUPROFEN 200 mg/1 30142-123_1143f968-8f9d-451a-a14a-b7b12c4d209a 30142-123 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120712 ANDA ANDA202300 The Kroger Co. IBUPROFEN 200 mg/1 30142-124_46d6d916-dafc-47f1-a404-ab1aeca8df97 30142-124 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 19980623 ANDA ANDA090711 Kroger Company NICOTINE 2 mg/1 30142-130_5a8095b7-ab6f-493d-92fb-456d98f528b1 30142-130 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 19900815 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL 30142-133_20109585-c4f6-413c-a5b1-eaf88a9419d5 30142-133 HUMAN OTC DRUG flu and sore throat acetaminophen,pheniramine maleate, phenylephrine hydrochloride POWDER, FOR SUSPENSION ORAL 20120409 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 30142-136_f67770d5-99ef-4a6f-8568-39793f8c1654 30142-136 HUMAN OTC DRUG Peptic Relief Cherry Bismuth Subsalicylate SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part335 Kroger BISMUTH SUBSALICYLATE 262 mg/15mL 30142-139_b79eccf7-757f-4552-b4a4-6b87cb61063f 30142-139 HUMAN OTC DRUG Cold and Allergy PE Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20060831 OTC MONOGRAPH FINAL part341 Kroger Company CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 30142-140_97de57b2-9753-47b9-b2c3-974166406d00 30142-140 HUMAN OTC DRUG Antacid calcium carbonate TABLET ORAL 20101018 20190131 OTC MONOGRAPH FINAL part331 The Kroger Co. CALCIUM CARBONATE 750 mg/1 30142-141_78e0e7d2-3710-4ed5-b5fa-91b8bb361a34 30142-141 HUMAN OTC DRUG heartburn prevention original strength Famotidine TABLET ORAL 20091009 ANDA ANDA075400 Kroger Company FAMOTIDINE 10 mg/1 30142-143_f27cf879-14c7-4ce3-8d8e-28819ec05800 30142-143 HUMAN OTC DRUG miconazole 7 Miconazole nitrate CREAM VAGINAL 19990428 ANDA ANDA074760 Kroger Company MICONAZOLE NITRATE 2 g/100g 30142-145_e80d2aa8-2aa3-499e-ae00-c8d672408653 30142-145 HUMAN OTC DRUG mucus relief cold and sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130626 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 30142-148_a1d3315e-db65-4810-8981-bad10cfe47b7 30142-148 HUMAN OTC DRUG Kroger Sensitive Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Kroger Company POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 30142-149_6acdcf94-a2f4-4b74-a1d8-92921914d330 30142-149 HUMAN OTC DRUG Kroger Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Kroger POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 30142-153_3a5b5591-c1e4-44dd-9b12-beb1dc223ae1 30142-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Kroger Co PYRITHIONE ZINC 1 kg/100L 30142-154_86888bc4-039e-44ee-aa1a-7348dfe2b652 30142-154 HUMAN OTC DRUG Flu Relief Therapy Night Time Acetaminophen, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20090603 OTC MONOGRAPH FINAL part341 Kroger ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL 30142-155_3b01697c-463a-4e61-974f-e79d723f965d 30142-155 HUMAN OTC DRUG Flu Relief Therapy Day Time Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20090603 OTC MONOGRAPH FINAL part341 Kroger ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 30142-158_c5f276c2-f56c-43eb-b9bb-21f323d7f449 30142-158 HUMAN OTC DRUG nighttime sleep aid Doxylamine succinate TABLET ORAL 20140715 ANDA ANDA040167 Kroger Company DOXYLAMINE SUCCINATE 25 mg/1 30142-160_1c03feda-7dfd-43f1-82cb-5e3af55500e6 30142-160 HUMAN OTC DRUG Senna- S docusate sodium and sennosides TABLET ORAL 20100712 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 30142-161_f31b589a-a53e-4cef-89ef-d7ef295384ff 30142-161 HUMAN OTC DRUG Pain and Fever Acetaminophen SUSPENSION ORAL 20110808 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL 30142-163_2c8f3138-a70b-4cd9-a8e9-58ea689b205d 30142-163 HUMAN OTC DRUG Anticavity SODIUM FLUORIDE MOUTHWASH ORAL 20050912 OTC MONOGRAPH FINAL part355 Kroger SODIUM FLUORIDE 999.5 mL/100L 30142-166_02956bff-0458-431f-b0db-d7c8622fd3fa 30142-166 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION ORAL 20021120 ANDA ANDA074937 Kroger Company IBUPROFEN 100 mg/5mL 30142-167_4a340196-5385-43cc-98f5-01567d699359 30142-167 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110202 ANDA ANDA072199 The Kroger Co. IBUPROFEN 200 mg/1 30142-168_b54e5369-a49e-46b5-b3f4-4702e62321f8 30142-168 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20110202 ANDA ANDA079096 The Kroger Co. NAPROXEN SODIUM 220 mg/1 30142-170_6b0d030b-5b82-4630-b169-3b434391d3d1 30142-170 HUMAN OTC DRUG nicotine polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20051215 ANDA ANDA076789 Kroger Company NICOTINE 4 mg/1 30142-173_55ec8a32-0de0-4eee-8afc-08693790fb0d 30142-173 HUMAN OTC DRUG Lice Complete Kit Piperonyl Butoxide, Pyrethrum Extract KIT 20130726 OTC MONOGRAPH FINAL part358G Kroger Company 30142-174_70998f74-2d1b-4ec1-91d5-ae4ff17ed462 30142-174 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141031 NDA NDA021920 The Kroger Co. NAPROXEN SODIUM 220 mg/1 30142-175_b23c9195-cdee-46a1-ad8a-ac1a91ef7356 30142-175 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 19931231 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL 30142-176_bdbe7bdc-4066-423d-9bc0-6fc3a87905d4 30142-176 HUMAN OTC DRUG all day allergy d Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20140219 ANDA ANDA077170 Kroger Company CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 30142-177_8cea8663-c6c3-42fd-b653-d01ae280dba0 30142-177 HUMAN OTC DRUG Naproxen Sodium Naproxen sodium TABLET, FILM COATED ORAL 20050208 ANDA ANDA074661 Kroger Company NAPROXEN SODIUM 220 mg/1 30142-178_97de57b2-9753-47b9-b2c3-974166406d00 30142-178 HUMAN OTC DRUG Antacid calcium carbonate TABLET ORAL 20101018 20190131 OTC MONOGRAPH FINAL part331 The Kroger Co. CALCIUM CARBONATE 750 mg/1 30142-179_a75bc21d-97fb-492a-ba95-ee600314baf9 30142-179 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20080724 OTC MONOGRAPH FINAL part333B Kroger Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 30142-180_a401cef9-1aa5-433e-b54d-0d190d606d36 30142-180 HUMAN OTC DRUG Healing petrolatum OINTMENT TOPICAL 19880215 OTC MONOGRAPH FINAL part347 The Kroger CO. PETROLATUM 340 mg/g 30142-181_49fdaede-99cd-48bf-aefb-e13c7193991d 30142-181 HUMAN OTC DRUG Menstrual Complete Acetaminophen, Caffeine, Pyrilamine maleate TABLET ORAL 20140328 OTC MONOGRAPH NOT FINAL part343 The Kroger Co. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 30142-182_a78a601f-fb4c-4e27-a104-7198a9886c0d 30142-182 HUMAN OTC DRUG childrens pain and fever Acetaminophen SUSPENSION ORAL 20001214 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL 30142-183_ab8ee2d9-09d4-4459-a15b-181712a20627 30142-183 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19930228 ANDA ANDA077349 Kroger Company IBUPROFEN 200 mg/1 30142-187_af9efa5e-fff4-414e-9415-24b1ade36c3d 30142-187 HUMAN OTC DRUG pain relief Acetaminophen TABLET, COATED ORAL 19941028 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 500 mg/1 30142-188_0e617e0a-955a-463f-a26b-cc0df467b9e5 30142-188 HUMAN OTC DRUG Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20131213 OTC MONOGRAPH FINAL part346 Kroger Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 30142-190_aa2569bf-dc7d-4ca7-a793-a0e548859b5c 30142-190 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20100914 ANDA ANDA090711 Kroger Company NICOTINE 4 mg/1 30142-191_e98608f7-4c21-49ca-8a1a-1d61a943dbae 30142-191 HUMAN OTC DRUG Bisacodyl Bisacodyl TABLET, COATED ORAL 20131230 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. BISACODYL 5 mg/1 30142-196_aa9784cc-1e0c-418a-956a-2113653997b9 30142-196 HUMAN OTC DRUG childrens pain relief plus cough and sore throat Acetaminophen, Dextromethorphan HBr SUSPENSION ORAL 20080825 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 5 mg/5mL; mg/5mL 30142-198_efc9dfb4-2eb0-4c44-8862-f326ff1ab137 30142-198 HUMAN OTC DRUG Ibuprofen IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20100701 ANDA ANDA078682 The Kroger Co. IBUPROFEN 200 mg/1 30142-199_bfd3d19c-f216-4233-89a8-cb529e12f7ee 30142-199 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100608 ANDA ANDA079114 Kroger Company 30142-201_92edcd32-9bac-46f7-ab61-0a7dde6513aa 30142-201 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 19910515 ANDA ANDA090821 Kroger Company NICOTINE 2 mg/1 30142-202_63c34754-acb3-4508-83b3-24cfcc1f8673 30142-202 HUMAN OTC DRUG hair regrowth treatment for women minoxidil SOLUTION TOPICAL 20110205 ANDA ANDA075357 Kroger Company MINOXIDIL 2 g/100mL 30142-203_8b379e7b-18ea-4dba-86e0-70c987d3db72 30142-203 HUMAN OTC DRUG Waterless Hand Sanitizer Alcohol GEL TOPICAL 19971212 OTC MONOGRAPH NOT FINAL part333A Kroger ALCOHOL .65 mL/100L 30142-205_51f40e49-914b-4541-b763-eae1ae2aa49b 30142-205 HUMAN OTC DRUG Therapeutic T Plus Coal Tar SHAMPOO TOPICAL 20110331 OTC MONOGRAPH FINAL part358H The Kroger Co COAL TAR 5 mg/mL 30142-206_a1214e28-756f-4147-a9c0-011231ba195b 30142-206 HUMAN OTC DRUG nicotine stop smoking aid Nicotine Polacrilex GUM, CHEWING ORAL 20060507 ANDA ANDA078325 Kroger Company NICOTINE 2 mg/1 30142-211_609bf63b-e7cf-4bdb-8e08-adb33d9a0168 30142-211 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20131230 NDA NDA022429 The Kroger Co. CETIRIZINE HYDROCHLORIDE 10 mg/1 30142-214_57fbbe97-93cd-44d9-9ea3-ac0894937f41 30142-214 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090222 OTC MONOGRAPH NOT FINAL part356 Kroger HYDROGEN PEROXIDE 2.65 mL/100mL 30142-215_c76e63cf-0ba3-465d-9be1-54b73d720787 30142-215 HUMAN OTC DRUG daytime non drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20080830 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 30142-216_c46c7b0c-1423-4097-b948-608d5d8a241a 30142-216 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part335 Kroger BISMUTH SUBSALICYLATE 262 mg/15mL 30142-217_633a68ec-52ce-4ea2-9b2f-f7000eacda45 30142-217 HUMAN OTC DRUG pain relief 8 hr Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050816 ANDA ANDA075077 Kroger Company ACETAMINOPHEN 650 mg/1 30142-218_f6f078d9-4ca8-4e61-bd9e-62e4662bcdeb 30142-218 HUMAN OTC DRUG Clear Anti Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 19940301 OTC MONOGRAPH FINAL part347 Kroger Co PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL 30142-219_24cba53c-8855-40d0-90f8-dac76fba12f4 30142-219 HUMAN OTC DRUG Blackhead Clearing Scrub Salicylic acid GEL TOPICAL 20140118 OTC MONOGRAPH FINAL part333D The Kroger Co. SALICYLIC ACID 19.4 mg/g 30142-222_0163ff98-29be-4851-a91d-86e1e6ee04b0 30142-222 HUMAN OTC DRUG Daytime Nitetime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20141103 OTC MONOGRAPH FINAL part341 Kroger Company 30142-224_6e3dcf75-aa90-4e46-bf98-d6d0bb0b018b 30142-224 HUMAN OTC DRUG Peptic Relief Maximum Strength BISMUTH SUBSALICYLATE SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part341 Kroger BISMUTH SUBSALICYLATE 525 mg/15mL 30142-225_c28cc203-7c00-47a0-a0ee-6462d3636ea3 30142-225 HUMAN OTC DRUG EZ Nite Sleep Nighttime Sleep-Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130411 OTC MONOGRAPH FINAL part338 The Kroger Co. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 30142-226_ae85c531-3753-4160-927c-bde5a08a80dd 30142-226 HUMAN OTC DRUG Creamy Diaper Rash Zinc Oxide OINTMENT TOPICAL 19940619 OTC MONOGRAPH FINAL part347 Kroger Co. ZINC OXIDE 13 kg/100kg 30142-227_f1fa1f25-7920-4541-bea4-18236ad50458 30142-227 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET, COATED ORAL 20050921 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 500 mg/1 30142-230_7b7a0cc8-f1e5-4629-9f16-ef8799fc150e 30142-230 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20100712 OTC MONOGRAPH FINAL part341 The Kroger Co DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 30142-231_73040112-231c-46ba-aa6a-0f00672a2055 30142-231 HUMAN OTC DRUG WATERLESS HAND SANITIZER ETHYL ALCOHOL GAS TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY ALCOHOL 62 mL/100mL 30142-234_65c01986-4d4c-41b6-883b-ecd3ee74d1e3 30142-234 HUMAN OTC DRUG cold head congestion severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 19910215 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 30142-236_c5f93c78-a332-48c8-b1c1-516ff38a36fc 30142-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 The Kroger Co. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 30142-238_47c38eab-eaba-4248-a1de-1cc926883c14 30142-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130730 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. DOCUSATE SODIUM 100 mg/1 30142-242_ab83cff5-1ab5-4b41-b1e3-ad53a896974b 30142-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131015 OTC MONOGRAPH FINAL part347 The Kroger Co. DIMETHICONE 125 mg/1 30142-243_6081dc7f-e2b6-4cd4-bf4b-7aa54921654e 30142-243 HUMAN OTC DRUG Antibacterial Hand Triclosan LIQUID TOPICAL 20090105 OTC MONOGRAPH FINAL part333A Kroger Co TRICLOSAN .15 kg/100L 30142-244_f6d4e7e8-e98f-481d-a621-daa203d5050b 30142-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131230 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. DOCUSATE SODIUM 100 mg/1 30142-245_7727432c-1afd-4bc0-8115-ea238d1ff1db 30142-245 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20131230 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. SENNOSIDES 25 mg/1 30142-246_60b33eae-34c9-43ad-8621-8066b6f9854e 30142-246 HUMAN OTC DRUG Medicated Dandruff Selenium sulfide SHAMPOO TOPICAL 19900115 OTC MONOGRAPH FINAL part358H KROGER Co SELENIUM SULFIDE 1 kg/100L 30142-247_22291d87-6f80-48cc-a4c1-d81245ba32e4 30142-247 HUMAN OTC DRUG Advanced Healing Petrolatum OINTMENT TOPICAL 20121101 OTC MONOGRAPH FINAL part347 Kroger Co PETROLATUM 340 mg/100g 30142-249_65aec907-f3ee-43c2-921e-c4629e5a6686 30142-249 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20140228 ANDA ANDA079174 The Kroger Co. IBUPROFEN 200 mg/1 30142-250_58bb1eb1-0039-498c-9ac3-b63d85d4b753 30142-250 HUMAN OTC DRUG cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20070908 OTC MONOGRAPH FINAL part341 Kroger Company 30142-251_eee9b174-c297-4e69-a4ed-5f1f01f39c46 30142-251 HUMAN OTC DRUG arthricream Trolamine Salicylate CREAM TOPICAL 19920204 OTC MONOGRAPH NOT FINAL part348 Kroger Company TROLAMINE SALICYLATE 10 g/100g 30142-254_3580ff70-4de1-41f2-9042-831c937f7589 30142-254 HUMAN OTC DRUG Flu Relief Therapy Night Time Acetaminophen, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20090616 OTC MONOGRAPH FINAL part341 Kroger ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL 30142-255_e98b17fe-f7f8-494d-9301-d4e6a51a83ef 30142-255 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20100515 ANDA ANDA075217 Kroger Company IBUPROFEN 50 mg/1.25mL 30142-263_2f2d2472-4589-4587-9d77-20dc0f3f85cf 30142-263 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20131217 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL 30142-264_c62092e1-1e9a-4022-b495-5583606832a3 30142-264 HUMAN OTC DRUG Daily Acne Control Cleanser Benzoyl peroxide CREAM TOPICAL 20140818 OTC MONOGRAPH FINAL part333D Kroger Inc BENZOYL PEROXIDE 104 mg/10g 30142-271_6392bf6c-5494-4da1-b3c5-ffe5c24fab15 30142-271 HUMAN OTC DRUG Heartburn Relief Acid Reducer Ranitidine TABLET ORAL 20090522 ANDA ANDA076760 Kroger Company RANITIDINE HYDROCHLORIDE 75 mg/1 30142-272_60ae6dbc-2a74-49b3-9106-1849b6218cc6 30142-272 HUMAN OTC DRUG Sinus Congestion and Pain Daytime Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20070309 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 30142-274_bf05552d-af41-45a9-9fad-d9217f2e7caf 30142-274 HUMAN OTC DRUG aspirin low dose Aspirin TABLET, CHEWABLE ORAL 19970617 OTC MONOGRAPH NOT FINAL part343 Kroger Company ASPIRIN 81 mg/1 30142-279_d44ca22a-dc20-454d-99aa-403a8c7a3e00 30142-279 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140823 OTC MONOGRAPH FINAL part346 Kroger Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 30142-282_2888d734-2b33-4c5d-acc8-8f428bc6f66e 30142-282 HUMAN OTC DRUG dayhist allergy 12 hour relief Clemastine fumarate TABLET ORAL 19960807 ANDA ANDA074512 Kroger Company CLEMASTINE FUMARATE 1.34 mg/1 30142-289_b4e86da3-6667-456b-a0b3-6bb263c0740a 30142-289 HUMAN OTC DRUG pain relief concentrated infants Acetaminophen SUSPENSION/ DROPS ORAL 19931231 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 80 mg/.8mL 30142-291_b8dc39e1-e03e-4db8-a76d-dba72aad9a49 30142-291 HUMAN OTC DRUG anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 20001004 UNAPPROVED DRUG OTHER Kroger Company DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 30142-294_fa2ef3ef-ee6e-46bd-828b-a35b070ed3cc 30142-294 HUMAN OTC DRUG hair regrowth treatment for men Minoxidil AEROSOL, FOAM TOPICAL 20120410 ANDA ANDA091344 Kroger Company MINOXIDIL 5 g/100g 30142-296_ad1ce031-d270-4da7-b15d-b4bcc14bb9b2 30142-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20110401 OTC MONOGRAPH FINAL part358H The Kroger Co PYRITHIONE ZINC 10 mg/mL 30142-299_5edc6a10-ad2a-4fb6-a6e9-fb3d9af03d5c 30142-299 HUMAN OTC DRUG Alcohol Free Antiseptic cetylpyridinium chloride MOUTHWASH ORAL 20090515 OTC MONOGRAPH NOT FINAL part356 Kroger Co CETYLPYRIDINIUM CHLORIDE .7 mg/mL 30142-302_469d08ac-b471-41f8-89a7-a85849e305cf 30142-302 HUMAN OTC DRUG stomach relief original strength Bismuth subsalicylate LIQUID ORAL 19890115 OTC MONOGRAPH FINAL part335 Kroger Company BISMUTH SUBSALICYLATE 262 mg/15mL 30142-304_b0217e69-8da3-4776-9ecc-a999ca6987ef 30142-304 HUMAN OTC DRUG Nasal oxymetazoline hydrochloride SPRAY NASAL 19901115 OTC MONOGRAPH FINAL part341 Kroger Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 30142-305_7a407ec8-ef2b-4fe2-836c-01154dcc4225 30142-305 HUMAN OTC DRUG Kroger ATHLETES FOOT Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Kroger Company CLOTRIMAZOLE 10 mg/g 30142-306_808d408d-25a9-41fa-bc4a-a7bf80333e2a 30142-306 HUMAN OTC DRUG gentle lax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 Kroger Company POLYETHYLENE GLYCOL 3350 17 g/17g 30142-308_4f01ae48-5f49-49dd-860e-a0eabb6e3d08 30142-308 HUMAN OTC DRUG cold multi symptom severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20080820 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 30142-310_7057f228-3b41-4fa4-a106-7968b7bd94da 30142-310 HUMAN OTC DRUG tussin adults non drowsy Guaifenesin SYRUP ORAL 19911212 OTC MONOGRAPH FINAL part341 Kroger Company GUAIFENESIN 200 mg/10mL 30142-311_b1e96c6f-ac2f-44f0-a8d5-eae640e17bf4 30142-311 HUMAN OTC DRUG Everyday Clean Pyrithione Zinc SHAMPOO TOPICAL 20110401 OTC MONOGRAPH FINAL part358H Kroger Co PYRITHIONE ZINC 1 kg/100L 30142-313_05ff95ab-ef1d-44f7-863e-3d6c6458af0b 30142-313 HUMAN OTC DRUG acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140519 ANDA ANDA075077 Kroger Company ACETAMINOPHEN 650 mg/1 30142-318_7c9f6b8a-3a91-4152-9276-321eb6971d9d 30142-318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 19910615 OTC MONOGRAPH NOT FINAL part356 Kroger Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 30142-320_4d5d97c8-8902-4f50-a922-58fcfe1321ef 30142-320 HUMAN OTC DRUG Kroger Toothache Pain Relief Benzocaine PASTE, DENTIFRICE TOPICAL 20110120 OTC MONOGRAPH FINAL part333B Kroger BENZOCAINE 20 g/100g 30142-321_efb93229-06ce-4d2d-a3a3-6545c20f48bf 30142-321 HUMAN OTC DRUG Dual Action Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080909 ANDA ANDA077355 Kroger Company CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 30142-326_d1c1e534-26e9-4788-888c-4e395296da20 30142-326 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130801 OTC MONOGRAPH NOT FINAL part356 Kroger Co. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 30142-327_e0708482-5973-4090-9380-404c9249ca47 30142-327 HUMAN OTC DRUG lubricating relief Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20130222 OTC MONOGRAPH FINAL part349 Kroger Company POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL 30142-328_4f2df02f-0d4f-4e87-8212-4b7b958d3cfe 30142-328 HUMAN OTC DRUG sore throat spray Phenol SPRAY ORAL 19930121 OTC MONOGRAPH NOT FINAL part356 Kroger Company PHENOL 10.628 mg/100mL 30142-332_b9dc90be-8ed4-472f-81d5-e370f11aa1de 30142-332 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide SUSPENSION ORAL 19991020 OTC MONOGRAPH NOT FINAL part334 Kroger Company MAGNESIUM HYDROXIDE 1200 mg/15mL 30142-335_38bcb980-cff6-4031-9094-c81dafae9a6c 30142-335 HUMAN OTC DRUG nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110827 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 30142-337_430a811b-12ad-4905-92c2-bed945c0db48 30142-337 HUMAN OTC DRUG stomach relief Bismuth subsalicylate LIQUID ORAL 19900915 OTC MONOGRAPH FINAL part335 Kroger Company BISMUTH SUBSALICYLATE 525 mg/15mL 30142-338_a8713f2a-87fb-420b-b73c-91362bbfebc6 30142-338 HUMAN OTC DRUG moisturizing lubricant Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20130222 OTC MONOGRAPH FINAL part349 Kroger Company CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL 30142-340_61df6221-602e-4ef6-a0c9-02ec6c00f375 30142-340 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED ORAL 20140211 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 500 mg/1 30142-341_4236cdaf-8df1-4f41-9409-c713b782de2a 30142-341 HUMAN OTC DRUG Hydrocortisone Maximum Strength Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 20080701 OTC MONOGRAPH NOT FINAL part348 The Kroger Company HYDROCORTISONE 1 g/100g 30142-343_06c34bc7-fd71-4d91-81b0-5241fcfa404f 30142-343 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20080724 OTC MONOGRAPH NOT FINAL part348 The Kroger Company HYDROCORTISONE 1 g/100g 30142-344_c6d66ad4-97f7-4130-8381-70b5170191e6 30142-344 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20070427 ANDA ANDA077007 Kroger Company NICOTINE 2 mg/1 30142-345_327b0e4c-d697-48b7-a708-0dcc318d8417 30142-345 HUMAN OTC DRUG severe sinus congestion Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140514 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 30142-352_74d0d953-02fb-4ab1-87f4-41dd43e013b6 30142-352 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070915 ANDA ANDA078547 Kroger Company NICOTINE 2 mg/1 30142-357_ed5e4a10-02fe-4853-9a06-2378df496ba4 30142-357 HUMAN OTC DRUG Antacid regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 19870715 OTC MONOGRAPH FINAL part332 Kroger Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 30142-358_5d512290-a6d4-499b-a368-878149850ac1 30142-358 HUMAN OTC DRUG sinus and allergy pe maximum strength Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20070406 OTC MONOGRAPH FINAL part341 Kroger Company CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 30142-359_dc3d503a-22de-4db8-9bcf-0bea5ebf599a 30142-359 HUMAN OTC DRUG Tussin Dextromethorphan HBr, Guaifenesin LIQUID ORAL 19911104 OTC MONOGRAPH FINAL part341 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 30142-360_6ece9713-caa9-4c43-a754-ae50316cdf87 30142-360 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20090522 OTC MONOGRAPH NOT FINAL part334 Kroger MINERAL OIL 15 mL/15mL 30142-361_255d8148-18d6-44dd-9b40-6fb153cc7e0e 30142-361 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, COATED ORAL 20140501 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 500 mg/1 30142-368_c7ce61f6-cea9-4ea9-81b3-69e3a1d5610b 30142-368 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET, FILM COATED ORAL 19970116 ANDA ANDA074661 Kroger Company NAPROXEN SODIUM 220 mg/1 30142-370_07f97c85-6c19-4e94-823d-c0f8e1f93ce7 30142-370 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20110110 OTC MONOGRAPH NOT FINAL part343 The Kroger Co. ASPIRIN 325 mg/1 30142-374_ead5476c-9340-4c90-b010-3dd7ce59c916 30142-374 HUMAN OTC DRUG migraine formula Acetaminophen, Aspirin, Caffeine TABLET ORAL 20021120 ANDA ANDA075794 Kroger Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 30142-378_3a20fbd9-dd33-41bf-a7e3-fd389a44022c 30142-378 HUMAN OTC DRUG Renew Mirra Deep Moisture Day Ensulizole, Octinoxate CREAM TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part352 Kroger Company ENSULIZOLE; OCTINOXATE 2; 7.5 g/100g; g/100g 30142-379_920d2ebd-b436-4326-8090-e0dfe7e12d6a 30142-379 HUMAN OTC DRUG allergy Diphenhydramine HCl LIQUID ORAL 19870715 OTC MONOGRAPH FINAL part341 Kroger Company DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 30142-380_098cfbdb-862b-4d00-b5a9-33481e40591b 30142-380 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090803 OTC MONOGRAPH FINAL part333 Kroger ISOPROPYL ALCOHOL 91 mL/100mL 30142-381_0e6af16c-536a-4d05-8bb7-368eae16c0a6 30142-381 HUMAN OTC DRUG Mucus Relief cold flu and sore throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130704 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 30142-384_95051fe4-b42d-4395-b8d0-6889cc6d2fab 30142-384 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120828 ANDA ANDA091135 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 30142-388_ecf1bd2f-e467-4735-ba76-44cca1bed6f7 30142-388 HUMAN OTC DRUG nasal Oxymetazoline HCl SPRAY NASAL 20021120 OTC MONOGRAPH FINAL part341 Kroger Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 30142-396_8087eb65-543d-49e8-ac43-1237ef0209a6 30142-396 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 19991020 OTC MONOGRAPH NOT FINAL part334 Kroger Company MAGNESIUM HYDROXIDE 1200 mg/15mL 30142-397_1b91e8a1-3455-4fd2-bf74-bb0946a15306 30142-397 HUMAN OTC DRUG pain relief childrens acetaminophen LIQUID ORAL 20120916 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL 30142-400_c4b31240-dd78-471c-b298-2d493f003938 30142-400 HUMAN OTC DRUG Hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 19960103 OTC MONOGRAPH FINAL part346 Kroger Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 30142-401_eeca8c38-e167-4f69-88fa-efd7307205d8 30142-401 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET ORAL 20121102 OTC MONOGRAPH FINAL part336 The Kroger Co. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 30142-403_c7918b73-faf4-405c-951f-f79a64ab9dfc 30142-403 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20140512 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 325 mg/1 30142-404_ab12c975-2085-4365-9c4b-0be573a260c4 30142-404 HUMAN OTC DRUG Childrens Allergy Relief Diphenhydramine HCl SOLUTION ORAL 20140204 OTC MONOGRAPH FINAL part341 Kroger Company DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 30142-405_7c4284bd-93b2-48bc-a89b-93a3f1579fac 30142-405 HUMAN OTC DRUG KROGER WATERLESS HAND SANITIZER CITRUS SCENT ETHYL ALCOHOL LIQUID TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY ALCOHOL 700 mg/mL 30142-405_db4fe5ba-09ff-4cfb-914f-b47b2e46ed84 30142-405 HUMAN OTC DRUG KROGER WATERLESS HAND SANITIZER CITRUS SCENT ETHYL ALCOHOL LIQUID TOPICAL 20140325 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY ALCOHOL 700 mg/mL 30142-406_63d3ed8a-008b-4f1a-82cf-6a8f4295cee5 30142-406 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090707 OTC MONOGRAPH FINAL part333 Kroger ISOPROPYL ALCOHOL 50 mL/100mL 30142-408_67d96e61-ccb0-439b-84ae-97da50322f06 30142-408 HUMAN OTC DRUG Kroger Cold Sore Treatment Camphor CREAM TOPICAL 20130430 OTC MONOGRAPH NOT FINAL part348 The Kroger Co. BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g 30142-409_1b69d25e-1206-416c-a99b-96e00c1b9f2b 30142-409 HUMAN OTC DRUG stay awake Caffeine TABLET ORAL 19940617 OTC MONOGRAPH FINAL part340 Kroger Company CAFFEINE 200 mg/1 30142-410_1223a6ea-61bf-4faa-af01-e65a5f43fc35 30142-410 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140123 OTC MONOGRAPH NOT FINAL part333A Kroger Co ALCOHOL 585 mg/mL 30142-414_ffe1c2cf-5c91-4ff3-a7d4-dbe0989d546e 30142-414 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090714 OTC MONOGRAPH NOT FINAL part356 Kroger HYDROGEN PEROXIDE 2.65 mL/100mL 30142-416_49612c93-e8b2-4109-b27f-75fbdc076dd1 30142-416 HUMAN OTC DRUG Aspirin Regular Strength Aspirin TABLET ORAL 19871115 OTC MONOGRAPH NOT FINAL part343 Kroger Company ASPIRIN 325 mg/1 30142-417_c3a5c7f6-025d-4f98-bbe4-a165fc0b17c3 30142-417 HUMAN OTC DRUG Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130821 ANDA ANDA076518 Kroger Company NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 30142-419_18bfbf99-012f-4301-abce-c83089ec8261 30142-419 HUMAN OTC DRUG childrens mucus relief cough Dextromethorphan hbr, Guaifenesin LIQUID ORAL 20070926 OTC MONOGRAPH FINAL part341 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 30142-422_2d59fc38-1a41-46d5-8e5d-695be31c360f 30142-422 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20060507 ANDA ANDA078326 Kroger Company NICOTINE 4 mg/1 30142-423_0155c3f0-43e6-4469-b3c3-47262c417f22 30142-423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 The Kroger Company IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 30142-424_6e9fe875-01e4-470c-8aec-d54ffac13f23 30142-424 HUMAN OTC DRUG nicotine Nicotine Polacrilex LOZENGE ORAL 20100914 ANDA ANDA090821 Kroger Company NICOTINE 4 mg/1 30142-425_ce87a63c-7060-405f-9da4-acdc8a229806 30142-425 HUMAN OTC DRUG fexo fenadine Fexofenadine HCl TABLET, FILM COATED ORAL 20110816 ANDA ANDA076447 Kroger Company FEXOFENADINE HYDROCHLORIDE 60 mg/1 30142-430_b5138d28-a678-4b06-877f-e11cde98eba0 30142-430 HUMAN OTC DRUG headache formula added strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19970130 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 30142-431_62424915-3a6a-49fd-9b2f-3c0e44a12582 30142-431 HUMAN OTC DRUG nighttime sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20010205 OTC MONOGRAPH FINAL part338 Kroger Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 30142-432_21cdd6cc-8cda-409c-a618-4428e18f8f88 30142-432 HUMAN OTC DRUG nasal decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 19870715 OTC MONOGRAPH FINAL part341 Kroger Company PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 30142-434_2b4c2b26-e9ed-489e-a708-162162f9d95f 30142-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130801 OTC MONOGRAPH NOT FINAL part356 Kroger Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 30142-437_63be15fd-15c3-4f8d-bfd8-71793718dfb3 30142-437 HUMAN OTC DRUG pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19920714 OTC MONOGRAPH FINAL part338 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 30142-439_19aa984e-4370-4f54-a63d-eb5caeb0f2ca 30142-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333A The Kroger CO. ALCOHOL 700 mg/mL 30142-440_1ee88c69-f379-411b-9d69-5b45c6f4f1a1 30142-440 HUMAN OTC DRUG Aspirin Enteric Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 20040224 OTC MONOGRAPH FINAL part343 The Kroger Co ASPIRIN 81 mg/1 30142-441_b743663b-5df6-4b00-b80f-372707124318 30142-441 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 19970502 ANDA ANDA040167 Kroger Company DOXYLAMINE SUCCINATE 25 mg/1 30142-445_2591b775-3344-4e13-a393-63c671cd2812 30142-445 HUMAN OTC DRUG Flu and Severe Cold and Cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20140228 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 30142-455_f488504c-69bf-4a15-929f-a5a7d94e123a 30142-455 HUMAN OTC DRUG childrens pain and fever Acetaminophen SUSPENSION ORAL 20131214 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL 30142-456_ad3be9d3-a5ea-4401-b6e4-26281cf83887 30142-456 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070427 ANDA ANDA076777 Kroger Company NICOTINE 2 mg/1 30142-458_a37433be-6cbe-456d-b5eb-65cc88f138a4 30142-458 HUMAN OTC DRUG All Day Allergy Cetirizine Hydrochloride TABLET ORAL 20080108 ANDA ANDA078336 Kroger Company CETIRIZINE HYDROCHLORIDE 10 mg/1 30142-459_224be279-b3bb-46ce-9267-be4a2d2a8136 30142-459 HUMAN OTC DRUG nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110826 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 30142-461_65255b22-4fda-4338-aadd-8c6c3c740780 30142-461 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20040510 ANDA ANDA076359 Kroger Company IBUPROFEN 100 mg/1 30142-462_db4b9b56-e8ec-4522-b378-78985e2718bd 30142-462 HUMAN OTC DRUG allergy diphenhydramine hydrochloride CAPSULE ORAL 19900815 OTC MONOGRAPH FINAL part341 Kroger Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 30142-463_3806a047-5207-4241-b088-48c7343d7ad4 30142-463 HUMAN OTC DRUG Allergy Chlorpheniramine Maleate TABLET ORAL 19870715 OTC MONOGRAPH FINAL part341 Kroger Company CHLORPHENIRAMINE MALEATE 4 mg/1 30142-467_4ad157c2-bc63-44b0-9788-d462322e5b99 30142-467 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 19921006 OTC MONOGRAPH NOT FINAL part343 Kroger Company ASPIRIN 81 mg/1 30142-469_2ad97fdc-7294-4f82-81d0-3c3e7a82d9ff 30142-469 HUMAN OTC DRUG Stomach relief chewables Bismuth subsalicylate TABLET, CHEWABLE ORAL 19911010 OTC MONOGRAPH FINAL part335 Kroger Company BISMUTH SUBSALICYLATE 262 mg/1 30142-476_533ffca8-4e33-42ff-87f3-f91220ee1cd4 30142-476 HUMAN OTC DRUG allergy multi symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20060821 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 30142-477_65a77997-8ab5-419f-8ed5-7af3972a8b22 30142-477 HUMAN OTC DRUG fiber laxative Calcium polycarbophil TABLET, FILM COATED ORAL 19970207 OTC MONOGRAPH NOT FINAL part334 Kroger Company CALCIUM POLYCARBOPHIL 625 mg/1 30142-479_3ea91280-ebf9-4be8-abd0-658a82d7b8bd 30142-479 HUMAN OTC DRUG Allergy Diphenhydramine Hydrochloride TABLET ORAL 19870915 OTC MONOGRAPH FINAL part341 Kroger Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 30142-482_aec19ba3-8c30-4d41-b262-232d87053255 30142-482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20140507 OTC MONOGRAPH FINAL part355 The Kroger Co SODIUM FLUORIDE .1 mg/mL 30142-484_fd5b9e8f-40a6-46a8-a45f-043fa236fd91 30142-484 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 19870715 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 500 mg/1 30142-490_f245f5a6-88b6-4bb4-91f1-b4a91eaac3b3 30142-490 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET ORAL 20040510 ANDA ANDA074661 Kroger Company NAPROXEN SODIUM 220 mg/1 30142-498_64185a96-b80f-4abf-a842-4183dc05619f 30142-498 HUMAN OTC DRUG mucus er Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130318 ANDA ANDA078912 Kroger Company GUAIFENESIN 600 mg/1 30142-500_776899ea-0b82-44c7-b277-f3fc2b5f2b6d 30142-500 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140306 ANDA ANDA074661 Kroger Company NAPROXEN SODIUM 220 mg/1 30142-501_40132ae6-c0f5-4a8a-866a-cce530a26457 30142-501 HUMAN OTC DRUG Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 20120223 OTC MONOGRAPH FINAL part333B Kroger Company BACITRACIN ZINC 500 [USP'U]/g 30142-503_d0e08710-3e95-4a5d-85bd-fe317757406e 30142-503 HUMAN OTC DRUG Allergy Relief Chlorpheniramine Maleate TABLET ORAL 19870715 OTC MONOGRAPH FINAL part341 Kroger Company CHLORPHENIRAMINE MALEATE 4 mg/1 30142-510_2ec8f755-9215-40a1-9eaa-6b4b16f827b4 30142-510 HUMAN OTC DRUG Kroger Jock Itch Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Kroger Company CLOTRIMAZOLE 10 mg/g 30142-511_8ebbad0a-9ce1-4d88-b7c7-e1d0f11e3973 30142-511 HUMAN OTC DRUG fast mucus relief Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20140730 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 30142-516_e7d7b669-778a-44bb-a3a5-742d39cb55f2 30142-516 HUMAN OTC DRUG tussin cf non drowsy Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 19890915 OTC MONOGRAPH FINAL part341 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 30142-517_c6cf28ca-16e7-46d4-9ec8-6d4f8f1a25c5 30142-517 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060427 ANDA ANDA077349 Kroger Company IBUPROFEN 200 mg/1 30142-519_f4cb5ad5-c8d8-4c81-a08e-443c00b6178d 30142-519 HUMAN OTC DRUG KROGER MEDICATED DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20140624 OTC MONOGRAPH FINAL part358H THE KROGER COMPANY SELENIUM SULFIDE 10 mg/mL 30142-525_55d35862-fdaa-4f6f-9880-c90686567410 30142-525 HUMAN OTC DRUG Anti-Itch Extra Strength diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20090126 OTC MONOGRAPH NOT FINAL part348 Kroger Company DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; 1 mg/g; mg/g 30142-532_e02d9600-2514-42fa-b2bf-32b487230932 30142-532 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 19920714 ANDA ANDA076779 Kroger Company NICOTINE 4 mg/1 30142-533_dea12fc8-cd7f-407e-8f66-0edbaec4ca3b 30142-533 HUMAN OTC DRUG athletes foot Tolnaftate CREAM TOPICAL 20120126 OTC MONOGRAPH FINAL part333C Kroger Company TOLNAFTATE 1 g/100g 30142-539_1c3dc4e6-452b-4c84-b53c-426cf9ae8f03 30142-539 HUMAN OTC DRUG nasal Phenylephrine hydrochloride SPRAY NASAL 20140218 OTC MONOGRAPH FINAL part341 Kroger Company PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 30142-544_4d7c0fd0-e101-4dcc-9746-c55abd2d0462 30142-544 HUMAN OTC DRUG arthritis pain relief temporary minor Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000606 ANDA ANDA075077 Kroger Company ACETAMINOPHEN 650 mg/1 30142-546_9cb8d0ea-cb24-4006-95b6-73703f3c8991 30142-546 HUMAN OTC DRUG Complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20081009 ANDA ANDA077355 Kroger Company CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 30142-548_8428d77f-b144-4389-8585-7652e24ad0af 30142-548 HUMAN OTC DRUG daytime severe cold and flu acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140822 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 30142-550_f6502735-ba3e-4817-94cf-508fd46c7a07 30142-550 HUMAN OTC DRUG Gas Relief SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100313 OTC MONOGRAPH FINAL part332 The Kroger Co DIMETHICONE 125 mg/1 30142-555_6ea5fb69-5e90-49bd-8b99-024e898344dd 30142-555 HUMAN OTC DRUG Allergy Relief Fexofenadine HCl TABLET, FILM COATED ORAL 20131219 ANDA ANDA076447 Kroger Company FEXOFENADINE HYDROCHLORIDE 60 mg/1 30142-557_015b1c8f-9d5b-4afc-a55c-1a731b5fc72a 30142-557 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080225 NDA NDA022032 Kroger Company OMEPRAZOLE 20 mg/1 30142-561_8fb19444-f0e0-4d26-81e8-6a4b835056d8 30142-561 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 19870715 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 500 mg/1 30142-567_0100f3be-972a-49c1-b6e3-da6d00944540 30142-567 HUMAN OTC DRUG NiteTime DayTime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20111112 OTC MONOGRAPH FINAL part341 Kroger Company 30142-567_4df6af87-4590-43c4-b5c5-59dfc5730b9b 30142-567 HUMAN OTC DRUG Nite Time Day Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130920 OTC MONOGRAPH FINAL part341 Kroger Company 30142-571_d7860465-1e2d-48b1-b7ef-6cc29aba3b4b 30142-571 HUMAN OTC DRUG fexo fenadine fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110416 ANDA ANDA076447 Kroger Company FEXOFENADINE HYDROCHLORIDE 180 mg/1 30142-578_78ff5d14-3385-4329-b1c4-29f5849c4c0a 30142-578 HUMAN OTC DRUG tussin dm adults Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19941103 OTC MONOGRAPH FINAL part341 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 30142-580_1fae07d7-2a67-409e-a630-897cb22a929b 30142-580 HUMAN OTC DRUG Daytime Nitetime Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140531 OTC MONOGRAPH FINAL part341 Kroger Company 30142-588_d1f7e46c-941c-42e8-b1ac-dd96a5a324f3 30142-588 HUMAN OTC DRUG antacid Aluminum Hydroxide, Magnesium Hydroxide, Simethicone SUSPENSION ORAL 20120514 OTC MONOGRAPH FINAL part332 Kroger Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 30142-590_00471e08-1cef-4584-ade9-91a258113b32 30142-590 HUMAN OTC DRUG pain and fever acetaminophen SUSPENSION ORAL 19930331 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL 30142-601_7f18ff4d-29da-4c6b-ab50-36c765957d92 30142-601 HUMAN OTC DRUG home sense Benzalkonium chloride CLOTH TOPICAL 20130509 OTC MONOGRAPH NOT FINAL part333A The Kroger Co. BENZALKONIUM CHLORIDE .115 g/1 30142-602_c17e57ab-3620-4a5f-8edf-2852884a7ede 30142-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 19931021 OTC MONOGRAPH FINAL part334 Kroger Co. MAGNESIUM SULFATE 1 g/g 30142-603_2d5d7f1a-1d5d-4fc1-86f6-3b4aa073565e 30142-603 HUMAN OTC DRUG daytime severe cold and flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20141010 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 30142-604_12af9a00-a7c3-48b4-b18f-8d9462a435f7 30142-604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET ORAL 19880115 ANDA ANDA072096 Kroger Company IBUPROFEN 200 mg/1 30142-607_7fc0926c-4085-4aa3-80c7-497eade7d930 30142-607 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090825 OTC MONOGRAPH FINAL part333 Kroger ISOPROPYL ALCOHOL 70 mL/100mL 30142-609_73c54582-1b1f-4ffe-af9b-4d7ce90901f8 30142-609 HUMAN OTC DRUG NiteTime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID ORAL 19940509 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 500; 15; 6.25; 30 mg/15mL; mg/15mL; mg/15mL; mg/15mL 30142-612_46233cf1-2d69-449b-a84e-bd07b784d395 30142-612 HUMAN OTC DRUG Allergy Relief Loratadine TABLET ORAL 20050822 ANDA ANDA076301 Kroger Company LORATADINE 10 mg/1 30142-615_af26df8c-e95b-4478-b0ff-dcdb13b48b44 30142-615 HUMAN OTC DRUG itchy eye Ketotifen SOLUTION OPHTHALMIC 20110527 ANDA ANDA077958 Kroger Company KETOTIFEN FUMARATE .25 mg/mL 30142-617_38f5a11f-3353-4b27-b17a-a64fe3e2eaf5 30142-617 HUMAN OTC DRUG naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 19970116 ANDA ANDA074661 Kroger Company NAPROXEN SODIUM 220 mg/1 30142-619_f6f2167f-0a71-4c22-866c-31e3711aff9a 30142-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 19870715 OTC MONOGRAPH FINAL part347 Kroger DIMETHICONE 13 mg/mL 30142-620_803b8c5d-a355-431e-8bbf-4d850127e10c 30142-620 HUMAN OTC DRUG Motion sickness Meclizine HCl TABLET ORAL 20100711 OTC MONOGRAPH FINAL part336 The Kroger Co. MECLIZINE HYDROCHLORIDE 25 mg/1 30142-621_17de1602-1e38-4345-b7b4-4dfc8e962c3f 30142-621 HUMAN OTC DRUG Kroger Company Radiant White Fluoride PASTE, DENTIFRICE DENTAL 20140224 OTC MONOGRAPH FINAL part355 Kroger Company SODIUM MONOFLUOROPHOSPHATE .76 g/100g 30142-640_32df3a90-d93f-41dc-9a17-f6e2ccafa44f 30142-640 HUMAN OTC DRUG Urinary Pain Relief Phenazopyridine Hydrochloride TABLET ORAL 20120511 UNAPPROVED DRUG OTHER The Kroger Co PHENAZOPYRIDINE 95 mg/1 30142-645_eda9cc11-584b-4ee4-9b50-8282291a2af2 30142-645 HUMAN OTC DRUG Loperamide Hydrochloride loperamide HCl SUSPENSION ORAL 20130806 ANDA ANDA091292 Kroger Company LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 30142-647_224f17e6-12c0-4749-92dc-7c96596943c0 30142-647 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 19901015 ANDA ANDA072096 Kroger Company IBUPROFEN 200 mg/1 30142-648_c8398189-4bf7-4e22-bd2d-a1c42445be8c 30142-648 HUMAN OTC DRUG Nasal Four Phenylephrine hydrochloride SPRAY NASAL 19910415 OTC MONOGRAPH FINAL part341 Kroger Company PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 30142-650_732fe82f-cdb4-4584-8c53-03efdf5ef7d1 30142-650 HUMAN OTC DRUG Allergy Relief Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20140128 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 30142-656_00f5c3e0-a303-4f9d-8431-f76a3ba495ba 30142-656 HUMAN OTC DRUG Day Time acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20060611 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 30142-660_64b547b7-2cd3-4cde-aeef-97114b64d97a 30142-660 HUMAN OTC DRUG Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20021120 ANDA ANDA074937 Kroger Company IBUPROFEN 100 mg/5mL 30142-663_ea01ada1-d36e-4cab-b1dd-a5356860d175 30142-663 HUMAN OTC DRUG Crisp Apple Hand Sani Ethyl Alcohol LIQUID TOPICAL 20140123 OTC MONOGRAPH NOT FINAL part333A Kroger ALCOHOL 585 g/mL 30142-664_7a16d65c-d9c8-4051-bd9f-7dab96d6cf4e 30142-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19940805 OTC MONOGRAPH NOT FINAL part356 Kroger CO. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 30142-668_74701621-377f-462e-b547-7a282ca8469f 30142-668 HUMAN OTC DRUG NiteTime Cough Dextromethorphan Hydrobromide, Doxylamine Succinate SOLUTION ORAL 20021120 OTC MONOGRAPH FINAL part341 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 30142-670_3668ae5b-d3c3-4f47-ace9-c7a39f55e1ab 30142-670 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine Hydrochloride TABLET ORAL 20110202 OTC MONOGRAPH FINAL part341 The Kroger Co. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 30142-678_e427445d-baff-42d7-abc4-1a45730b5622 30142-678 HUMAN OTC DRUG hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20121102 OTC MONOGRAPH FINAL part346 Kroger Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 30142-685_68393f1d-b8f0-47c2-8c51-7b30c875fc99 30142-685 HUMAN OTC DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20110425 ANDA ANDA074937 Kroger Company IBUPROFEN 100 mg/5mL 30142-686_cd016219-83fa-4c48-b821-287b9157fdef 30142-686 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20120719 OTC MONOGRAPH FINAL part334 Kroger Co MAGNESIUM CITRATE 1.745 g/29.6mL 30142-692_917a99b6-88ad-40a2-a4b7-943dc721608e 30142-692 HUMAN OTC DRUG cool heat Menthol, Methyl salicylate CREAM TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part348 Kroger Company MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g 30142-693_277ba8c1-bf95-4571-a2c3-b87887fa4956 30142-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20010503 OTC MONOGRAPH NOT FINAL part334 The Kroger Co MAGNESIUM CITRATE 1.745 g/29.6mL 30142-700_9c145df0-b261-469f-9494-7c1ffbfedd9c 30142-700 HUMAN OTC DRUG acetaminophen pm Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20140801 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 30142-702_11639a38-75b3-4633-8c7d-f0e12f670537 30142-702 HUMAN OTC DRUG Eye Itch Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140122 ANDA ANDA077958 Kroger Company KETOTIFEN FUMARATE .35 mg/mL 30142-704_6f6bd78f-16e1-445c-a47d-e3e63023f731 30142-704 HUMAN OTC DRUG daytime cold and flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20140930 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 30142-705_772bca5f-8075-4564-9cf6-a888d3dfe53a 30142-705 HUMAN OTC DRUG Illuminating Daily Moisturizer Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120517 OTC MONOGRAPH NOT FINAL part352 The Kroger Co. AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 mL/100mL; mL/100mL; mL/100mL 30142-707_95f858c8-ea23-4d24-9fbb-2f89083b34c7 30142-707 HUMAN OTC DRUG fast mucus relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140923 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 30142-724_3f692738-ebdc-41b4-8e04-65db5d12349f 30142-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 The Kroger Company LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 30142-729_607fe7b8-e65f-4285-870c-1d41f29ab31d 30142-729 HUMAN OTC DRUG KROGER DAILY FACE WASH SALICYLIC ACID LIQUID TOPICAL 20140922 OTC MONOGRAPH FINAL part333D THE KROGER COMPANY SALICYLIC ACID 20 mg/mL 30142-733_0d505f7e-b1e6-422d-a047-7cfbb2b322f7 30142-733 HUMAN OTC DRUG NiteTime DayTime acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20111112 OTC MONOGRAPH FINAL part341 Kroger Company 30142-733_77e72f64-09ca-47eb-b56d-d5c1cd38005a 30142-733 HUMAN OTC DRUG Nite Time Day Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130914 OTC MONOGRAPH FINAL part341 Kroger Company 30142-734_e738441f-48ae-47c8-9e32-622f98d32045 30142-734 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20130509 ANDA ANDA203690 Kroger Company NICOTINE 2 mg/1 30142-737_ba5a2121-49b4-483f-95e3-2db9071e6881 30142-737 HUMAN OTC DRUG Miconazole 1 Miconazole nitrate KIT 20130723 ANDA ANDA079114 Kroger Company 30142-742_290ffba0-d512-4502-bff4-900d1615b0a8 30142-742 HUMAN OTC DRUG Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20101123 NDA NDA021920 Kroger Company NAPROXEN SODIUM 220 mg/1 30142-751_40cf7b55-114a-4487-ac79-40cc728442c2 30142-751 HUMAN OTC DRUG pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120123 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 30142-758_745f5fe5-46ca-46e5-9878-94f785a811dc 30142-758 HUMAN OTC DRUG Nitetime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20141006 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 30142-763_2c9ef0d7-3d5b-494a-8f06-9dd42110d78a 30142-763 HUMAN OTC DRUG NiteTime Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20140813 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 30142-766_e8583383-a3c8-4b35-959d-9970bfdeb115 30142-766 HUMAN OTC DRUG infants pain and fever Acetaminophen SUSPENSION ORAL 20120315 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL 30142-770_d0ca4f20-a1e6-45ea-ab3c-dc35bec3ef23 30142-770 HUMAN OTC DRUG Itchy Eye Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140122 ANDA ANDA077958 Kroger Company KETOTIFEN FUMARATE .35 mg/mL 30142-791_db9a0e77-5cef-4cfd-a24c-c0273ed7f421 30142-791 HUMAN OTC DRUG Kroger Medicated Wipes Hemorrhoidal Wipe with Witch Hazel and Aloe Witch Hazel CLOTH TOPICAL 20100101 OTC MONOGRAPH FINAL part346 The Kroger Co. WITCH HAZEL .5 g/g 30142-798_65ea8e4b-b6f0-4f45-a45a-71a380fabb81 30142-798 HUMAN OTC DRUG Hair Regrowth Treatment Extra Strength for Men Minoxidil SOLUTION TOPICAL 20091205 ANDA ANDA075598 Kroger Company MINOXIDIL 3 g/60mL 30142-799_0b8d2d21-cfe9-4f86-83a8-3eb9ce361f23 30142-799 HUMAN OTC DRUG Tussin DM Max non drowsy Dextromethorphan HBr, Guaifenesin SUSPENSION ORAL 20100804 OTC MONOGRAPH FINAL part341 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 30142-800_83fabf20-a55e-43fb-981d-ae47df466e77 30142-800 HUMAN OTC DRUG acetaminophen pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20140805 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 30142-801_df579366-c16d-4ced-b719-98fac5245ee0 30142-801 HUMAN OTC DRUG ANTIBACTERIAL BODY WASH TRICLOSAN LIQUID TOPICAL 20110609 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY TRICLOSAN .15 mL/100mL 30142-802_0a26c4b7-302a-4cc7-a7a2-2d7ce18811bd 30142-802 HUMAN OTC DRUG K CARE OCEAN MIST BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY BENZALKONIUM CHLORIDE 1.3 mg/mL 30142-804_55bd33d3-d9de-4298-83c2-eb3474e98293 30142-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A The Kroger Co ISOPROPYL ALCOHOL .91 mg/mL 30142-807_b8c0b0d0-4c44-4000-8627-2e640996ecd6 30142-807 HUMAN OTC DRUG Cold Remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20090805 UNAPPROVED HOMEOPATHIC Kroger Company ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 30142-809_4eca7228-4bfc-4b6c-839e-73b02faa4d54 30142-809 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20100331 OTC MONOGRAPH NOT FINAL part333 The Kroger Company ISOPROPYL ALCOHOL 70 mL/1 30142-809_b2da8a62-6efa-4a35-9388-d861b9732d56 30142-809 HUMAN OTC DRUG Alcohol Isopropyl Alcohol SWAB TOPICAL 20100331 OTC MONOGRAPH NOT FINAL part333A The Kroger Company ISOPROPYL ALCOHOL 70 mL/100mL 30142-816_ba1cf26a-adb2-4649-b0ec-82a6b9c136be 30142-816 HUMAN OTC DRUG Dandruff Selenium sulfide SHAMPOO TOPICAL 20130601 OTC MONOGRAPH FINAL part358H Kroger SELENIUM SULFIDE 10 mg/mL 30142-817_d315595b-515c-42a8-9b75-d51fee27a182 30142-817 HUMAN OTC DRUG Nasal oxymetazoline hydrochloride SPRAY NASAL 20010924 OTC MONOGRAPH FINAL part341 Kroger Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 30142-818_d965eba0-b268-41b2-8e02-5f6d769a44d7 30142-818 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20140212 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL 30142-822_99ed27f5-16a3-4e77-b331-c3ce1567f4cf 30142-822 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 19890715 OTC MONOGRAPH FINAL part346 kroger Co WITCH HAZEL 979 mg/mL 30142-823_d82fb8bd-ed94-4d4d-976a-f18425c89be7 30142-823 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Maximum Strength bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride OINTMENT TOPICAL 20080724 OTC MONOGRAPH FINAL part333B Kroger Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 30142-825_e46890e5-38d6-4305-ab5f-d94e44092a10 30142-825 HUMAN OTC DRUG Miconazole 7 Miconazole nitrate CREAM VAGINAL 20020715 ANDA ANDA074760 Kroger Company MICONAZOLE NITRATE 2 g/100g 30142-829_81368f6a-2e41-4914-9698-dd66764ca88e 30142-829 HUMAN OTC DRUG pain relief pm extra strength Acetaminophen, Diphenhydramine HCl CAPSULE, COATED ORAL 20100804 OTC MONOGRAPH FINAL part338 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 30142-831_b3b4103f-9aea-40a1-9381-1abede6de146 30142-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part334 Kroger Co MINERAL OIL 999 mg/mL 30142-837_bc0108c5-533a-4396-ba61-aa35afd2636d 30142-837 HUMAN OTC DRUG pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 19971015 OTC MONOGRAPH FINAL part338 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 30142-839_0e067d8f-bea7-4fe0-9f48-9786662c3fb3 30142-839 HUMAN OTC DRUG Childrens Mucus Relief dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20140517 OTC MONOGRAPH FINAL part341 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 30142-845_1b09b2f6-590e-4a9b-9d25-793c7c77e563 30142-845 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19890715 OTC MONOGRAPH FINAL part344 Kroger Co ISOPROPYL ALCOHOL 613 mg/mL 30142-851_c5c9e15b-9641-4037-abb2-69ac244ab8e6 30142-851 HUMAN OTC DRUG antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20021210 OTC MONOGRAPH FINAL part332 Kroger Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 30142-852_bf2d703a-2cb6-47c3-8f97-bf593d5d1bc9 30142-852 HUMAN OTC DRUG Heartburn Relief Ranitidine TABLET, FILM COATED ORAL 20130831 ANDA ANDA091429 Kroger Company RANITIDINE HYDROCHLORIDE 150 mg/1 30142-854_13a32e6b-b082-428c-ae75-53b83ea231ce 30142-854 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20070915 ANDA ANDA078546 Kroger Company NICOTINE 4 mg/1 30142-861_369f4736-5ee2-41b1-a188-86812916f344 30142-861 HUMAN OTC DRUG Nicotine nicotine polacrilex LOZENGE ORAL 20110811 NDA NDA021330 Kroger Company NICOTINE 2 mg/1 30142-862_369f4736-5ee2-41b1-a188-86812916f344 30142-862 HUMAN OTC DRUG Nicotine nicotine polacrilex LOZENGE ORAL 20110811 NDA NDA021330 Kroger Company NICOTINE 4 mg/1 30142-863_369f4736-5ee2-41b1-a188-86812916f344 30142-863 HUMAN OTC DRUG Nicotine nicotine polacrilex LOZENGE ORAL 20110811 NDA NDA021330 Kroger Company NICOTINE 2 mg/1 30142-864_369f4736-5ee2-41b1-a188-86812916f344 30142-864 HUMAN OTC DRUG Nicotine nicotine polacrilex LOZENGE ORAL 20110811 NDA NDA021330 Kroger Company NICOTINE 4 mg/1 30142-866_ec5cdcd1-ad0c-4be3-8c2e-0eb17f9ff2e9 30142-866 HUMAN OTC DRUG lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070713 OTC MONOGRAPH FINAL part358G Kroger Company PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 30142-872_191f563b-5e76-48d8-a086-57cd730c86ad 30142-872 HUMAN OTC DRUG nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 19900215 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 30142-873_ff0e8a76-05e8-4186-a3ae-d0782a26e931 30142-873 HUMAN OTC DRUG Nicotine Nicotine polacrilex LOZENGE ORAL 20070427 ANDA ANDA077007 Kroger Company NICOTINE 4 mg/1 30142-880_9e1a4b47-50fc-4c56-b52c-bbff8850f05a 30142-880 HUMAN OTC DRUG Childrens Cold and Allergy phenylephrine hcl, brompheniramine maleate ELIXIR ORAL 20140227 OTC MONOGRAPH FINAL part341 Kroger Company BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 30142-882_31fdf8b5-cc51-40c6-81a7-8f0fae9df557 30142-882 HUMAN OTC DRUG gas relief infants Simethicone EMULSION ORAL 19990304 OTC MONOGRAPH FINAL part332 Kroger Company DIMETHICONE 20 mg/.3mL 30142-884_26ddaa9c-ed9e-4c71-a627-818944e195a3 30142-884 HUMAN OTC DRUG All Day Allergy cetirizine Hydrochloride LIQUID ORAL 20110805 ANDA ANDA090254 Kroger Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 30142-886_8b1ca232-f84f-4d8f-9751-b103aa9337fb 30142-886 HUMAN OTC DRUG sinus Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20070908 OTC MONOGRAPH FINAL part341 Kroger Company 30142-886_de146264-1592-486a-8cd1-7eb99f466d56 30142-886 HUMAN OTC DRUG sinus congestion and pain daytime night time Acetaminophen,Phenylephrine HCl, Chlorpheniramine maleate KIT 20110416 OTC MONOGRAPH FINAL part341 Kroger Company 30142-888_ce4ee3f9-ecb7-4faf-a308-9aff4610ee4a 30142-888 HUMAN OTC DRUG Fast Mucus Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140728 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 30142-890_2d530d96-fdba-435f-9eae-99ca4e6aecd9 30142-890 HUMAN OTC DRUG Cold and Allergy PE Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20110202 OTC MONOGRAPH FINAL part341 The Kroger Co. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 30142-897_d77964da-8cda-4402-a07f-6fcb8b407f7f 30142-897 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990119 ANDA ANDA074937 Kroger Company IBUPROFEN 100 mg/5mL 30142-900_948785e9-ff77-4008-abee-7797200390b8 30142-900 HUMAN OTC DRUG Kroger Burn Relief Aloe LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part348 THE KROGER CO LIDOCAINE HYDROCHLORIDE .5 g/100g 30142-901_756a8156-c4d5-4a74-9a1a-2dec6c24634f 30142-901 HUMAN OTC DRUG Kroger Sport Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g 30142-902_065976f1-db9d-4851-916a-d6cb74a73d71 30142-902 HUMAN OTC DRUG Kroger Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g 30142-903_dbbb442c-3636-4bd5-9aea-09330f8ebed4 30142-903 HUMAN OTC DRUG Multi Symptom Cold Childrens Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20080811 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 30142-904_503d3e83-23dc-4c22-b7cc-695d806d5c72 30142-904 HUMAN OTC DRUG Kroger Dark Tanning Oil SPF 4 OCTINOXATE SPRAY TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO OCTINOXATE 3 g/100g 30142-905_e204f640-e55d-42e3-8ba7-5c07b3f9961d 30142-905 HUMAN OTC DRUG Kroger Aloe Vera Pain Relieving LIDOCAINE MENTHOL LOTION TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part348 THE KROGER CO LIDOCAINE; MENTHOL .7; .2 g/100g; g/100g 30142-906_259807d0-e992-4541-a0bd-8192c65f4b14 30142-906 HUMAN OTC DRUG Kroger Aloe Vera Pain Relieving LIDOCAINE MENTHOL GEL TOPICAL 20121129 OTC MONOGRAPH NOT FINAL part348 THE KROGER CO LIDOCAINE; MENTHOL .7; .2 g/100g; g/100g 30142-907_c6fbaa47-a89e-4501-b286-3cac64761f89 30142-907 HUMAN OTC DRUG Kroger Baby SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130812 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 30142-908_77357955-5cde-4ce9-96f1-25325859420b 30142-908 HUMAN OTC DRUG Nite Time acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20060407 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 30142-909_aaf8045d-412d-4684-89a7-e724632ae5f8 30142-909 HUMAN OTC DRUG Kroger SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130906 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 30142-910_2940a59b-ccf5-45e1-8cf5-4beae9501af2 30142-910 HUMAN OTC DRUG Nicotine polacrilex nicotine polacrilex GUM, CHEWING ORAL 20110804 NDA NDA018612 Kroger Company NICOTINE 2 mg/1 30142-911_2940a59b-ccf5-45e1-8cf5-4beae9501af2 30142-911 HUMAN OTC DRUG Nicotine polacrilex nicotine polacrilex GUM, CHEWING ORAL 20110804 NDA NDA020066 Kroger Company NICOTINE 4 mg/1 30142-912_2940a59b-ccf5-45e1-8cf5-4beae9501af2 30142-912 HUMAN OTC DRUG Nicotine polacrilex nicotine polacrilex GUM, CHEWING ORAL 20110804 NDA NDA018612 Kroger Company NICOTINE 2 mg/1 30142-913_2940a59b-ccf5-45e1-8cf5-4beae9501af2 30142-913 HUMAN OTC DRUG Nicotine polacrilex nicotine polacrilex GUM, CHEWING ORAL 20110804 NDA NDA020066 Kroger Company NICOTINE 4 mg/1 30142-914_2940a59b-ccf5-45e1-8cf5-4beae9501af2 30142-914 HUMAN OTC DRUG Nicotine polacrilex nicotine polacrilex GUM, CHEWING ORAL 20110804 NDA NDA018612 Kroger Company NICOTINE 2 mg/1 30142-915_2940a59b-ccf5-45e1-8cf5-4beae9501af2 30142-915 HUMAN OTC DRUG Nicotine polacrilex nicotine polacrilex GUM, CHEWING ORAL 20110804 NDA NDA020066 Kroger Company NICOTINE 4 mg/1 30142-916_2940a59b-ccf5-45e1-8cf5-4beae9501af2 30142-916 HUMAN OTC DRUG Nicotine polacrilex nicotine polacrilex GUM, CHEWING ORAL 20110726 NDA NDA018612 Kroger Company NICOTINE 2 mg/1 30142-917_f966e3b3-e82a-407c-b236-0e40b589be10 30142-917 HUMAN OTC DRUG pain relief extra strength Acetaminophen CAPSULE, COATED ORAL 20110401 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 500 mg/1 30142-918_2940a59b-ccf5-45e1-8cf5-4beae9501af2 30142-918 HUMAN OTC DRUG Nicotine polacrilex nicotine polacrilex GUM, CHEWING ORAL 20110817 NDA NDA020066 Kroger Company NICOTINE 4 mg/1 30142-919_651fbd81-8a76-4e15-818f-e56b29d12821 30142-919 HUMAN OTC DRUG Kroger Sport sunscreen SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g 30142-920_1089fee5-a882-4980-ba4a-27197a15d66f 30142-920 HUMAN OTC DRUG Kroger Kroger Kids Sunscreen SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE SPRAY TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g 30142-921_b824a52d-99b7-44b0-924c-b33c6e6f82c5 30142-921 HUMAN OTC DRUG Kroger Oil Free Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g 30142-922_9a8743f0-ad25-4ff5-a470-d70255d8a07f 30142-922 HUMAN OTC DRUG Kroger Sheer Dry Touch Sunscreen SPF 55 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.8; 6 g/100g; g/100g; g/100g; g/100g; g/100g 30142-923_0ef39648-fac1-45ea-a655-1c95f74cfc6e 30142-923 HUMAN OTC DRUG eye itch Ketotifen Fumarate SOLUTION OPHTHALMIC 20101016 ANDA ANDA077958 Kroger Company KETOTIFEN FUMARATE .25 mg/mL 30142-924_534e0dac-6c5f-4288-b286-eb2be49b805f 30142-924 HUMAN OTC DRUG Kroger Sheer Dry Touch Sunscreen SPF 70 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2.8; 6 g/100g; g/100g; g/100g; g/100g; g/100g 30142-925_dd4e11af-dd4a-4a4d-88ec-fcfc24496be5 30142-925 HUMAN OTC DRUG Kroger Sunscreen SPF 8 OCTINOXATE OXYBENZONE LOTION TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 30142-926_b67e5473-7075-4d17-bb50-ea4ffeb1c23c 30142-926 HUMAN OTC DRUG Daytime NiteTime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20060828 OTC MONOGRAPH FINAL part341 Kroger Company 30142-927_129b8e0d-0e49-4151-99a5-d2faf580b24a 30142-927 HUMAN OTC DRUG Kroger Kids Sunscreen SPF 70 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g 30142-928_ff16d7e2-816c-47e1-8d05-fd5c6f721813 30142-928 HUMAN OTC DRUG Kroger Baby Sunscreen SPF 70 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g 30142-929_74ce61f3-b066-41bb-94fa-c2a1aa792a96 30142-929 HUMAN OTC DRUG KROGER SPF 4 TANNING OIL OCTINOXATE, PADIMATE O SPRAY TOPICAL 20130814 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO OCTINOXATE; PADIMATE O 2; 1.4 g/100g; g/100g 30142-930_559abce4-cedf-4385-975e-82e6b3bcceba 30142-930 HUMAN OTC DRUG Kroger Lip Treatment Petrolatum GEL TOPICAL 20130502 OTC MONOGRAPH FINAL part347 Kroger PETROLATUM 99.98 mg/g 30142-931_897c8709-e798-4bfd-80f0-1b8831682c13 30142-931 HUMAN OTC DRUG Kroger Moisture SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kroger OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 40.7 mg/g; mg/g; mg/g 30142-932_ca9df950-d581-4bad-9431-aff5f00bdc98 30142-932 HUMAN OTC DRUG Kroger Kids SPF 50 Sunstick Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone STICK TOPICAL 20130429 OTC MONOGRAPH NOT FINAL part352 Kroger AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 7.5; 5; 10; 4 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g 30142-933_307b1b1c-8277-4883-9ff3-d77d9f67b1f7 30142-933 HUMAN OTC DRUG Kroger Sport SPF 50 Sunstick Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone STICK TOPICAL 20130429 OTC MONOGRAPH NOT FINAL part352 Kroger AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 7.5; 5; 10; 4 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g 30142-935_f29c0224-fa17-46a5-ba20-1dba9c6ef02c 30142-935 HUMAN OTC DRUG night time sinus congestion and pain Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20110731 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 30142-936_0df5a49f-b1e9-4d7b-b7f4-4972ec1f44b4 30142-936 HUMAN OTC DRUG Kroger Sport Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20140623 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g 30142-937_d2737fad-aaab-44de-a704-919442e19692 30142-937 HUMAN OTC DRUG Kroger Sport Sunscreen SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20140627 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g 30142-938_8069eb88-814e-4e03-8ee4-dd94261f18d0 30142-938 HUMAN OTC DRUG Kroger Sport Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20140627 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g 30142-939_1df04f44-e9ce-4be8-b639-8568c319acbc 30142-939 HUMAN OTC DRUG KROGER SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140623 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100g; g/100g; g/100g; g/100g 30142-944_8596c3c6-077c-4db9-9e17-5f59c759db02 30142-944 HUMAN OTC DRUG hemorrhoidal maximum strength pain relief glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20091007 OTC MONOGRAPH FINAL part346 Kroger Company GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g 30142-946_8f0b3e6a-8bc0-4cea-8ef9-55efc26741bf 30142-946 HUMAN OTC DRUG pain and fever infants Acetaminophen SUSPENSION ORAL 20110920 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL 30142-950_7f94f002-5b13-4d7c-a94d-249814e18692 30142-950 HUMAN OTC DRUG heartburn relief Ranitidine TABLET, FILM COATED ORAL 20110920 ANDA ANDA091429 Kroger Company RANITIDINE HYDROCHLORIDE 150 mg/1 30142-951_696b6bda-a1ca-4ffa-9d68-b796dd6fde08 30142-951 HUMAN OTC DRUG Waterless Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20110228 OTC MONOGRAPH NOT FINAL part333A Kroger Co ALCOHOL 65 kg/100L 30142-952_c93613cf-f330-40a3-a0b9-cacbdf84749f 30142-952 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140618 OTC MONOGRAPH NOT FINAL part333A The Kroger Co BENZALKONIUM CHLORIDE .999 mg/mL 30142-957_a9d864ac-7c46-4c51-b4d5-74c37ce7f444 30142-957 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20130511 ANDA ANDA203690 Kroger Company NICOTINE 4 mg/1 30142-958_637fa434-c112-45ac-82d3-5eadb6ef47bc 30142-958 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130815 ANDA ANDA091135 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 30142-959_02bfba1b-5aa1-4870-a448-fea4466e21a5 30142-959 HUMAN OTC DRUG pain relief childrens Acetaminophen LIQUID ORAL 20120920 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL 30142-960_c3d5d378-e54b-4c05-9195-a53d456e4e20 30142-960 HUMAN OTC DRUG anti diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20030331 ANDA ANDA075232 Kroger Company LOPERAMIDE HYDROCHLORIDE 2 mg/1 30142-964_bb554c41-2c1b-4e91-8436-3b63e3aefdb6 30142-964 HUMAN OTC DRUG flu and severe cold and cough nighttime Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20100902 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 30142-966_17355953-ca8d-4948-985f-f6c5fe7f9e5b 30142-966 HUMAN OTC DRUG arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080311 ANDA ANDA075077 Kroger Company ACETAMINOPHEN 650 mg/1 30142-971_e683f2f7-7d80-4409-ba8c-8b189611e3cb 30142-971 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130626 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 30142-974_34121dc6-6abb-4a19-b8db-684f8137c5ee 30142-974 HUMAN OTC DRUG all day allergy cetirizine hydrochloride LIQUID ORAL 20080508 ANDA ANDA090254 Kroger Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 30142-975_8a84bb65-90a3-4bd3-b8c8-f77132c2dd98 30142-975 HUMAN OTC DRUG acetaminophen Acetaminophen TABLET ORAL 20140405 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 500 mg/1 30142-977_d5c997c5-20c2-4cb5-b538-20dd7d899207 30142-977 HUMAN OTC DRUG Nite Time multi symptom cold/flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20060509 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 30142-980_479d69a9-ad96-4190-b196-5a7ec85a0485 30142-980 HUMAN OTC DRUG all day relief Naproxen sodium TABLET, FILM COATED ORAL 20050208 ANDA ANDA074661 Kroger Company NAPROXEN SODIUM 220 mg/1 30142-982_ab80e0e9-81e7-4609-99a4-01ee9a3fe5b4 30142-982 HUMAN OTC DRUG miconazole 3 Miconazole nitrate KIT 20040817 ANDA ANDA076357 Kroger Company 30142-987_df49f0c8-95d3-4a9a-98a5-f114a93dc459 30142-987 HUMAN OTC DRUG Childrens Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20070821 OTC MONOGRAPH FINAL part341 Kroger Company BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 30142-990_76c95c40-43b6-426f-89c4-e584666678b7 30142-990 HUMAN OTC DRUG Nite Time Multi symptom cold flu relief - acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid LIQUID ORAL 20090805 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 30142-994_31224545-51d5-4513-8cfd-d727c83d795d 30142-994 HUMAN OTC DRUG daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20060605 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 30142-998_5dac576f-4c02-48d7-9680-43b8fb37f139 30142-998 HUMAN OTC DRUG Anti Diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030221 ANDA ANDA075232 Kroger Company LOPERAMIDE HYDROCHLORIDE 2 mg/1 30237-8900_589a95c9-70e7-4c49-b084-10c3d8aaab7e 30237-8900 CELLULAR THERAPY Provenge sipuelucel-T INJECTION INTRAVENOUS 20100429 BLA BLA125197 Dendreon Corporation SIPULEUCEL-T 50000000 1/1 Autologous Cellular Immunotherapy [EPC],Cell-mediated Immunity [PE],Cells, Cultured, Autologous [Chemical/Ingredient],Peripheral Blood Mononuclear Cells [Chemical/Ingredient] 30400-211_7b158cdf-4e11-49b0-bb85-07d6b32de6e5 30400-211 HUMAN OTC DRUG PETROLATUM PETROLATUM JELLY TOPICAL 20140424 OTC MONOGRAPH FINAL part347 Jell Pharmaceuticals Pvt. Ltd. PETROLATUM 1 g/g 30400-214_f294a17d-be59-4373-a5ae-109967412358 30400-214 HUMAN OTC DRUG Jell Pharmaceuticals Vitamin A D Petrolatum OINTMENT TOPICAL 20140424 OTC MONOGRAPH FINAL part347 Jell Pharmaceuticals Pvt. Ltd. PETROLATUM .76 g/g 30698-032_25c8b3f8-a223-41a1-a8b8-af5967dd4617 30698-032 HUMAN PRESCRIPTION DRUG Marplan isocarboxazid TABLET ORAL 19590701 NDA NDA011961 Validus Pharmaceuticals LLC ISOCARBOXAZID 10 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] 30698-143_989e933e-3757-4b1f-97af-22f99487e23f 30698-143 HUMAN PRESCRIPTION DRUG Rocaltrol calcitriol CAPSULE, GELATIN COATED ORAL 20090810 NDA NDA018044 Validus Pharmaceuticals LLC CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 30698-144_989e933e-3757-4b1f-97af-22f99487e23f 30698-144 HUMAN PRESCRIPTION DRUG Rocaltrol calcitriol CAPSULE, GELATIN COATED ORAL 20090810 NDA NDA018044 Validus Pharmaceuticals LLC CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 30698-201_4551302c-da8e-4a13-8afa-eb3dafa49be3 30698-201 HUMAN PRESCRIPTION DRUG Parlodel bromocriptine mesylate CAPSULE, GELATIN COATED ORAL 20140428 NDA NDA017962 Validus Pharmaceuticals LLC BROMOCRIPTINE MESYLATE 5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 30698-202_4551302c-da8e-4a13-8afa-eb3dafa49be3 30698-202 HUMAN PRESCRIPTION DRUG Parlodel bromocriptine mesylate TABLET ORAL 20140620 NDA NDA017962 Validus Pharmaceuticals LLC BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 30698-419_a90110c4-e26b-401f-b78b-7157edc254f5 30698-419 HUMAN PRESCRIPTION DRUG Equetro carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20041210 NDA NDA021710 Validus Pharmaceuticals LLC CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 30698-421_a90110c4-e26b-401f-b78b-7157edc254f5 30698-421 HUMAN PRESCRIPTION DRUG Equetro carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20041210 NDA NDA021710 Validus Pharmaceuticals LLC CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 30698-423_a90110c4-e26b-401f-b78b-7157edc254f5 30698-423 HUMAN PRESCRIPTION DRUG Equetro carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20041210 NDA NDA021710 Validus Pharmaceuticals LLC CARBAMAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 30698-449_2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e 30698-449 HUMAN PRESCRIPTION DRUG Lotensin benazepril hydrochloride TABLET ORAL 19910625 NDA NDA019851 Validus Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 30698-450_2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e 30698-450 HUMAN PRESCRIPTION DRUG Lotensin benazepril hydrochloride TABLET ORAL 19910625 NDA NDA019851 Validus Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 30698-452_b7e66e10-8b71-41b4-92d6-c092377a1e38 30698-452 HUMAN PRESCRIPTION DRUG Lotensin HCT benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 19920530 NDA NDA020033 Validus Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 30698-453_b7e66e10-8b71-41b4-92d6-c092377a1e38 30698-453 HUMAN PRESCRIPTION DRUG Lotensin HCT benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 19920530 NDA NDA020033 Validus Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 30698-454_b7e66e10-8b71-41b4-92d6-c092377a1e38 30698-454 HUMAN PRESCRIPTION DRUG Lotensin HCT benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 19920530 NDA NDA020033 Validus Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 30698-458_26e37315-4377-4466-ac4c-dea486200e67 30698-458 HUMAN PRESCRIPTION DRUG Lopressor metoprolol tartrate TABLET ORAL 20140505 NDA NDA017963 Validus Pharmaceuticals LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 30698-459_26e37315-4377-4466-ac4c-dea486200e67 30698-459 HUMAN PRESCRIPTION DRUG Lopressor metoprolol tartrate TABLET ORAL 20140505 NDA NDA017963 Validus Pharmaceuticals LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 30698-460_d8964894-3cd8-41c1-a844-148d2ef38a88 30698-460 HUMAN PRESCRIPTION DRUG Lopressor HCT metoprolol tartrate and hydrochlorothiazide TABLET ORAL 19841231 NDA NDA018303 Validus Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25; 50 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 30698-911_989e933e-3757-4b1f-97af-22f99487e23f 30698-911 HUMAN PRESCRIPTION DRUG Rocaltrol calcitriol SOLUTION ORAL 20090723 NDA NDA021068 Validus Pharmaceuticals LLC CALCITRIOL 1 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 30707-100_a3b2efec-4c54-4962-b6ad-517136097c47 30707-100 HUMAN OTC DRUG Hydrosal Professional Aluminum Chloride GEL TOPICAL 20071001 OTC MONOGRAPH FINAL part350 Valeo Pharma Corp. ALUMINUM CHLORIDE 15 g/100mL 30727-300_9cc1fcae-5031-48ff-acf3-2feea5b1bb79 30727-300 HUMAN PRESCRIPTION DRUG B-PLEX 100 Thiamine Hydrochloride, Riboflavin 5-Phosphate Sodium, Pyridoxine Hydrochloride, Dexpanthenol, Niacinamide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120101 UNAPPROVED DRUG OTHER Merit Pharmaceutical DEXPANTHENOL; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE 2; 100; 2; 2; 100 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 30727-304_14d3177b-f249-4372-9a7b-c9353a85b57a 30727-304 HUMAN PRESCRIPTION DRUG Chloromag Magnesium Chloride INJECTION, SOLUTION INTRAVENOUS 20110611 UNAPPROVED DRUG OTHER Merit Pharmaceutical MAGNESIUM CHLORIDE 200 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 30727-339_56bd11e4-3b8f-416a-99b9-fa833cd67441 30727-339 HUMAN PRESCRIPTION DRUG MEGA-C-ACID PLUS Ascorbic Acid INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100101 UNAPPROVED DRUG OTHER Merit Pharmaceutical ASCORBIC ACID 500 mg/mL 30803-001_8c7953ed-0a84-48c8-92a7-bfea6d064c55 30803-001 HUMAN OTC DRUG MAYINGLONG BEZORNIL HEMORRHOIDAL CALAMINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE OINTMENT RECTAL; TOPICAL 20130828 OTC MONOGRAPH FINAL part346 MAYINGLONG PHARMACEUTICAL GROUP CO LTD FERRIC OXIDE RED; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; ZINC OXIDE .05; 79.25; .25; 10.4 g/100g; g/100g; g/100g; g/100g 30805-001_e26843de-c8f0-4111-bc28-c4e7269b97ea 30805-001 HUMAN OTC DRUG Symmetry Hand Sanitizer Alcohol LIQUID TOPICAL 20071116 OTC MONOGRAPH NOT FINAL part333A Buckeye International, Inc. ALCOHOL 62 mL/100mL 30805-003_1c69caeb-7977-444d-a258-554aa571d184 30805-003 HUMAN OTC DRUG Symmetry Foaming Hand Sanitizer Alcohol LIQUID TOPICAL 20071116 OTC MONOGRAPH NOT FINAL part333A Buckeye International, Inc. ALCOHOL 62 mL/100mL 30805-006_50eebc94-9e59-44a2-bfcc-85c5652df7bd 30805-006 HUMAN OTC DRUG Symmetry Antimicrobial Foaming Hand Wash Chloroxylenol LIQUID TOPICAL 20071116 OTC MONOGRAPH NOT FINAL part333A Buckeye International, Inc. CHLOROXYLENOL .3 mL/100mL 30805-007_586c3d60-6616-47d7-b143-fe592b78feda 30805-007 HUMAN OTC DRUG Symmetry Non-Alcohol Foaming Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20090609 OTC MONOGRAPH NOT FINAL part333A Buckeye International, Inc. BENZALKONIUM CHLORIDE .24 mL/100mL 30805-008_c487349e-ced3-4afd-a24b-7340cc50190f 30805-008 HUMAN OTC DRUG Symmetry Foaming Hand Sanitizer-Unscented Ethyl Alcohol LIQUID TOPICAL 20100712 OTC MONOGRAPH NOT FINAL part333 Buckeye International, Inc. ALCOHOL 62 mL/100mL 30805-009_460190fe-bdd2-4fa5-9c50-4437f9933252 30805-009 HUMAN OTC DRUG Symmetry Foaming Hand Sanitizer-Fragrance Free with Aloe and Vitamin E Alcohol LIQUID TOPICAL 20111004 OTC MONOGRAPH NOT FINAL part333A Buckeye International, Inc. ALCOHOL 62 mL/100mL 30805-010_711350ec-95fd-4f2a-afdc-3e931ece233a 30805-010 HUMAN OTC DRUG Symmetry Non-Alcohol Foaming Hand Sanitizer with Allantoin and Aloe Benzalkonium Chloride LIQUID TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part333A Buckeye International, Inc. BENZALKONIUM CHLORIDE .12 mL/100mL 30807-2002_da7e8ff8-602e-4287-80a2-b3c155a17bfa 30807-2002 HUMAN OTC DRUG Quit Nits Advance quassia amara CREAM TOPICAL 20080101 UNAPPROVED HOMEOPATHIC Wild Child W A Pty Ltd QUASSIA 2 [HP_X]/60mL 30807-3003_d5e22b60-37f8-48e6-88bb-e3eea3efecfd 30807-3003 HUMAN OTC DRUG Quit Nits Preventative eucalyptus globulus SPRAY TOPICAL 20080101 UNAPPROVED HOMEOPATHIC Wild Child W A Pty Ltd EUCALYPTUS GLOBULUS LEAF 1 [HP_X]/125mL 31190-100_635267e1-2830-4bd8-ae57-7ca8017be8fa 31190-100 HUMAN OTC DRUG ALCOHOL FREE HAND SANITIZER BENZALKONIUM CHLORIDE AEROSOL, FOAM TOPICAL 20100407 OTC MONOGRAPH FINAL part333 Shanghai Kejing Cleaning Products Co., Ltd. BENZALKONIUM CHLORIDE .13 mL/100mL 31190-200_9be4854e-39ac-45ca-91d6-d01576baa281 31190-200 HUMAN OTC DRUG SunScreen SPF30 HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20100415 OTC MONOGRAPH FINAL part352 Shanghai Kejing Cleaning Products Co., Ltd. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 5; 7.5; 5; 4.25 mL/100mL; mL/100mL; mL/100mL; mL/100mL 31190-210_35f669b1-277a-4833-9f00-8ee0c885f964 31190-210 HUMAN OTC DRUG Sunscreen SPF 30 Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20140513 OTC MONOGRAPH NOT FINAL part352 Shanghai Kejing Cleaning Products Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 2.5 mg/mL; mg/mL; mg/mL; mg/mL 31190-300_2e6b561b-e522-428e-963b-a8907cc2fe2e 31190-300 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH ALOE and VITAMIN E ALCOHOL SPRAY TOPICAL 20100415 OTC MONOGRAPH FINAL part333 Shanghai Kejing Cleaning Products Co., Ltd. ALCOHOL 62 mL/100mL 31190-400_15e9feec-571e-4735-96d6-80dd3da1e101 31190-400 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20100415 OTC MONOGRAPH FINAL part333 Shanghai Kejing Cleaning Products Co., Ltd. ALCOHOL 62 mL/100mL 31190-500_672bc701-51b5-4c58-875e-75012e3bbf05 31190-500 HUMAN OTC DRUG SunScreen SPF30 OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20100422 OTC MONOGRAPH FINAL part352 Shanghai Kejing Cleaning Products Co., Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 2; 4; 2.5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 31190-700_f49b3311-e3b2-4616-b1b7-dd64b69f3e37 31190-700 HUMAN OTC DRUG SunScreen SPF 30 AVOBENZONE,OCTINOXATE, OCTISALATE, OXYBENZONE STICK TOPICAL 20110901 OTC MONOGRAPH FINAL part352 Shanghai Kejing Cleaning Products Co., Ltd. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 6 g/100g; g/100g; g/100g; g/100g 31190-800_18f704bc-ac5d-452b-94cc-138246717cac 31190-800 HUMAN OTC DRUG ALCOHOL FREE HAND SANITIZER BENZALKONIUM CHLORIDE GEL TOPICAL 20110902 OTC MONOGRAPH FINAL part333E Shanghai Kejing Cleaning Products Co., Ltd. BENZALKONIUM CHLORIDE .13 mL/100mL 31357-040_fc15862f-286e-4c65-b956-a478361d81fd 31357-040 HUMAN PRESCRIPTION DRUG AzaSite azithromycin SOLUTION OPHTHALMIC 20070716 NDA NDA050810 Inspire Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 10 mg/mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 31382-262_669e849c-0ce6-4ec5-93d8-a926a7d292bd 31382-262 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088389 CareStream Health, Inc. EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .02; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 31382-557_de328af3-2345-40cd-a393-ab91adc5c9a8 31382-557 HUMAN PRESCRIPTION DRUG Marcaine bupivacaine hydrochloride and epinephrine bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20130601 ANDA ANDA077250 Carestream Health Inc. BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE 5; .005 mg/mL; mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 31382-753_6710a1e1-d35a-4a23-a4cf-2caf76923cb1 31382-753 HUMAN PRESCRIPTION DRUG Carbocaine Mepivacaine hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA088387 Caresteam Health, Inc. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 31382-830_6e3ef2f8-0848-4bae-b8c4-d789f2dc8cd0 31382-830 HUMAN PRESCRIPTION DRUG Zorcaine Articaine hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20110901 NDA NDA020971 Carestream Health, Inc. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .018 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 31382-898_5fdd2159-3881-44dc-8438-791dffa6862e 31382-898 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088390 CareStream Health, Inc. EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 31382-931_6710a1e1-d35a-4a23-a4cf-2caf76923cb1 31382-931 HUMAN PRESCRIPTION DRUG Carbocaine with Neo-Cobefrin Mepivacaine hydrochloride and Levonordefrin INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA088388 Caresteam Health, Inc. LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE .05; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 31507-576_876f1175-8107-4af4-b39a-b47d2ce06107 31507-576 HUMAN OTC DRUG Hand Guard Foaming Antimicrobial TRICLOSAN SOAP TOPICAL 20120117 OTC MONOGRAPH NOT FINAL part333E Wechem, Inc. TRICLOSAN 3 mg/mL 31507-585_c958573b-3c11-47f6-bb6a-99ce8622516c 31507-585 HUMAN OTC DRUG Hand Guard Foaming Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120117 OTC MONOGRAPH NOT FINAL part333E Wechem, Inc. ALCOHOL .62 mL/mL 31511-007_118badbd-5285-4ce3-81ba-c3963b7d94dc 31511-007 HUMAN OTC DRUG Nobac Plus AB-F Benzalkonium Chloride LIQUID TOPICAL 20111129 OTC MONOGRAPH NOT FINAL part333A Mason Chemical Company BENZALKONIUM CHLORIDE .13 mL/100mL 31511-008_368ab37a-3a4d-4829-a896-ea132227a4cc 31511-008 HUMAN OTC DRUG Nobac Plus Benzalkonium Chloride LIQUID TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333A Mason Chemical Company BENZALKONIUM CHLORIDE .1 mL/100mL 31511-009_6fdb16b2-454e-4a07-8e6c-801922ed6b51 31511-009 HUMAN OTC DRUG Nobac Plus AB-F E2 Benzalkonium Chloride LIQUID TOPICAL 20120210 OTC MONOGRAPH NOT FINAL part333A Mason Chemical Company BENZALKONIUM CHLORIDE .13 mL/100mL 31511-010_c4f211af-2100-47cf-9b47-b01b0fbec216 31511-010 HUMAN OTC DRUG Nobac Plus E3 Benzalkonium Chloride LIQUID TOPICAL 20120210 OTC MONOGRAPH NOT FINAL part333A Mason Chemical Company BENZALKONIUM CHLORIDE .1 mL/100mL 31586-2683_518cb3cf-987a-425f-8679-7f17b710c175 31586-2683 HUMAN OTC DRUG Celadrin Menthol CREAM TOPICAL 20070430 OTC MONOGRAPH NOT FINAL part348 Natural Factors Nutritional Products Ltd MENTHOL 1.5 g/100g 31645-129_64b7910d-31f6-47c4-a46f-1b7a1c110b50 31645-129 HUMAN OTC DRUG Le Velvet Film Makeup Refill SPF 15 Octisalate, Titanium Dioxide PASTE TOPICAL 20000101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc OCTISALATE; TITANIUM DIOXIDE 5; 23 g/100g; g/100g 31645-140_6a77f09d-f698-4637-98ee-8417fa5c7f99 31645-140 HUMAN OTC DRUG Solar Powder SPF 20 Titanium Dioxide POWDER TOPICAL 20050101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE 3 g/100g 31645-142_47ad31b1-0409-43aa-89c0-b4b87faf46fa 31645-142 HUMAN OTC DRUG Mineral Wear Talc-Free Mineral Face Powder SPF 16 Titanium Dioxide, Zince Oxide POWDER TOPICAL 20070101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 6.2; 4.2 g/100g; g/100g 31645-145_60cc1acc-8336-4339-90b5-66f7489a60f7 31645-145 HUMAN OTC DRUG Organic Wear 100% Natural Origin Tinted Moisturizer SPF 15 TITANIUM DIOXIDE CREAM TOPICAL 20090201 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE 3.95 g/100g 31645-147_38bdac2b-4625-4a00-8805-794b6b7bbe27 31645-147 HUMAN OTC DRUG Mineral Wear Talc-Free Mineral Loose Powder SPF 16 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20080101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 12; 4.2 g/100g; g/100g 31645-149_bbd493ab-7d80-43ae-ae94-ccbb762ad35e 31645-149 HUMAN OTC DRUG MINERAL WEAR TALC FREE MINERAL TINTED MOISTURIZER SPF 15 TITANIUMDIOXIDE CREAM TOPICAL 20090201 OTC MONOGRAPH FINAL part352 PHYSICIANS FORMULA INC TITANIUM DIOXIDE 3.8 g/100g 31645-150_ae8b0ed3-3ab2-4eff-b2e1-b03ea04ea60a 31645-150 HUMAN OTC DRUG Healthy Wear Tinted Moisturizer SPF 50 Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20100301 OTC MONOGRAPH FINAL part352 Physicians Formula Inc. OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 8.5; 2.94 g/100g; g/100g; g/100g; g/100g 31645-151_e18df394-28de-4552-85cb-1adb65d28b97 31645-151 HUMAN OTC DRUG Healthy Wear Powder Foundation SPF 50 Octinoxate, Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20100301 OTC MONOGRAPH FINAL part352 Physicians Formula Inc OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4; 21; 3 g/100g; g/100g; g/100g 31645-152_a0b97114-8a98-4009-8ba3-ed0243c52699 31645-152 HUMAN OTC DRUG Healthy Wear Pressed Bronzer SPF 50 Octinoxate, Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20100301 OTC MONOGRAPH FINAL part352 Physicians Formula Inc OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4; 21; 3 g/100g; g/100g; g/100g 31645-153_c16ff44e-4a31-4af0-ab82-6603fa183f4a 31645-153 HUMAN OTC DRUG Mineral Wear Talc-Free Illuminating Powder Duo SPF 16 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20100301 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 12; 4.2 g/100g; g/100g 31645-154_c655a0c5-1911-4a6e-bdba-a92008ed719b 31645-154 HUMAN OTC DRUG Mineral Wear Talc-Free Illuminating Powder Duo SPF 16 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20100301 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 12; 4.2 g/100g; g/100g 31645-155_56ed3f89-e3ee-4743-8f50-511d40080aa6 31645-155 HUMAN OTC DRUG Mineral Wear Talc-Free Airbrushing Loose Powder SPF 30 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20110101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 15; 10 g/100g; g/100g 31645-156_353c503c-4f39-47a8-b28f-b67d17ae316d 31645-156 HUMAN OTC DRUG Mineral Wear Talc-Free Correcting Primer SPF 15 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20110201 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 2.9; 3 g/100g; g/100g 31645-157_f62baa71-5280-4985-8670-d9b9c8d8f931 31645-157 HUMAN OTC DRUG Wrinkle Corrector and Firming Moisturizer SPF 15 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20110715 OTC MONOGRAPH FINAL part352 Physicians Formula Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 3.75; 2.5; 2.75; 2 g/100g; g/100g; g/100g; g/100g; g/100g 31645-158_0eef79f2-66f6-45d0-8b98-f47b3a5cca48 31645-158 HUMAN OTC DRUG Hydrating and Balancing Moisturizer SPF 15 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20110715 OTC MONOGRAPH FINAL part352 Physicians Formula Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 3.75; 2.5; 2.75; 2 g/100g; g/100g; g/100g; g/100g; g/100g 31645-159_60b6bc89-53bd-4678-8ff1-e4019be8a477 31645-159 HUMAN OTC DRUG Mineral Wear Talc Free Airbrushing Pressed Powder SPF 30 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120102 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 15; 10 g/100g; g/100g 31645-160_e9cebb94-830f-420d-abd8-1f8db81a7e3e 31645-160 HUMAN OTC DRUG Youthful Wear Cosmeceutical Youth Boosting Foundation SPF 15 Zinc Oxide CREAM TOPICAL 20120101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc ZINC OXIDE 1.96 g/100g 31645-161_4f7d0fe6-a1bd-4d2c-93de-eefde64eead2 31645-161 HUMAN OTC DRUG MINERAL WEAR TALC FREE MINERAL AIRBRUSHING BRONZER SPF 30 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH FINAL part352 PHYSICIANS FORMULA INC TITANIUM DIOXIDE; ZINC OXIDE 15; 10 g/100g; g/100g 31645-162_d855a506-2567-42f8-ad22-b2b59538f7c4 31645-162 HUMAN OTC DRUG MINERAL WEAR TALC-FREE MINERAL AIRBRUSHING BLUSH SPF 30 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH FINAL part352 PHYSICIANS FORMULA INC TITANIUM DIOXIDE; ZINC OXIDE 15; 10 g/100g; g/100g 31645-163_710803a5-7f68-41bf-95b7-96e9ad53594e 31645-163 HUMAN OTC DRUG Super BB 10-in-1 Beauty Balm Concealer SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20130105 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 5.814; 6 g/100g; g/100g 31645-164_0b08e5f6-7ced-440c-8d3f-c4c79f498f58 31645-164 HUMAN OTC DRUG SUPER BB 10-IN-1 BEAUTY BALM CREAM SPF 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130105 OTC MONOGRAPH FINAL part352 PHYSICIANS FORMULA INC TITANIUM DIOXIDE; ZINC OXIDE 5.76; 2.94 g/100g; g/100g 31645-165_55fb5cee-2ed7-445f-ade4-99eef6225067 31645-165 HUMAN OTC DRUG SUPER BB All-in-1 Beauty Balm Powder SPF 30 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20130103 OTC MONOGRAPH FINAL part352 PHYSICIANS FORMULA INC TITANIUM DIOXIDE; ZINC OXIDE 15; 10 g/100g; g/100g 31645-166_c373afa6-ee14-41fd-8dd4-62abc599bafc 31645-166 HUMAN OTC DRUG Mineral Wear Talc-Free Mineral Liquid Foundation SPF 15 Titanium Dioxide CREAM TOPICAL 20070101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE 16 g/100g 31645-167_117fc9f2-0514-4b9b-a2ed-ce5a944bb716 31645-167 HUMAN OTC DRUG Mineral Wear Oh So Radiant Powder SPF 20 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20131201 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 10; 10 g/100g; g/100g 31645-168_ed24912b-8db5-4d19-bbac-8393710effd0 31645-168 HUMAN OTC DRUG Bronze Booster Beauty Balm BB Bronzer SPF 20 Titanium Dioxide POWDER TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE 6 g/100g 31645-169_54ff59ce-f3b1-4001-9a22-b2d55bb6d9f4 31645-169 HUMAN OTC DRUG Organic Wear CC Cream SPF 20 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20131201 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 3.9; 1 g/100g; g/100g 31645-170_5dbc510f-459b-4445-b01b-a7af7eb1e70e 31645-170 HUMAN OTC DRUG Super BB All-in-One Compact Cream SPF 30 Titanium Dioxide, Zinc Oxide PASTE TOPICAL 20131201 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 3.52; 4.48 g/100g; g/100g 31645-171_3b218eff-b444-4d07-8a04-985d859aeb74 31645-171 HUMAN OTC DRUG Bronze Booster BB Cream SPF 20 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 3.84; 1.96 g/100g; g/100g 31645-172_16cd3e74-2987-4d9d-83b0-cbac8861f63c 31645-172 HUMAN OTC DRUG Super CC Plus Concealer SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 5.8; 6 g/100g; g/100g 31645-173_b9e19cae-07e4-410a-9c60-92cda4a6b74b 31645-173 HUMAN OTC DRUG Super CC Plus Cream SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 5.76; 2.94 g/100g; g/100g 31645-174_41ff89fd-48a8-4da7-ae20-5dfb8db17300 31645-174 HUMAN OTC DRUG Youthful Wear Spotless Concealer SPF 15 Octinoxate LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Physicians Formula Inc OCTINOXATE 3 g/100g 31645-175_039d2ca0-8cba-484f-b7d6-94123f0b4325 31645-175 HUMAN OTC DRUG Youthful Wear Spotless Foundation SPF 15 octinoxate LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Physicians Formula Inc OCTINOXATE 3 g/100g 31645-176_a9f7180d-f979-4cc3-ac42-f60c947b1531 31645-176 HUMAN OTC DRUG Super CC Plus Powder SPF 30 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Physicians Formula TITANIUM DIOXIDE; ZINC OXIDE 15; 10 g/100g; g/100g 31645-177_b618b9a7-81e8-4881-9a31-ab614461ef79 31645-177 HUMAN OTC DRUG Youthful Wear Spotless Powder SPF 15 Titanium Dioxide POWDER TOPICAL 20131201 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE 2 g/100g 31720-011_f97b114c-8d60-4919-86fd-331cf846d502 31720-011 HUMAN OTC DRUG SEPHORA Flawless Moisturizing SPF 15 Sunscreen OCTINOXATE, ENSULIZOLE, OCTOCRYLENE, TITANIUM DIOXIDE LOTION TOPICAL 20100806 OTC MONOGRAPH NOT FINAL part352 S+ ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 30; 65; 30; 4 mg/mL; mg/mL; mg/mL; mg/mL 31720-012_832a82e7-1f88-4144-92cb-8821f6b94625 31720-012 HUMAN OTC DRUG Sephora Super Lisseur Rides SPF 15 Age Defy Moisture OCTINOXATE, OCTISALATE, OCTOCRYLENE, ENSULIZOLE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 S+ ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 17; 74.96; 50; 17; 4.5; 5.775 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 31720-012_a0e0108b-6ff5-4f20-89e4-7559514844e2 31720-012 HUMAN OTC DRUG Sephora Super Lisseur Rides SPF 15 Age Defy Moisture OCTINOXATE, OCTISALATE, OCTOCRYLENE, ENSULIZOLE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 S+ ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 17; 74.96; 50; 17; 4.5; 5.775 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 31720-101_d0c56e74-9c4f-46c7-a846-e7a31ef148c0 31720-101 HUMAN OTC DRUG Sephora Super Lisseur Rides Age Defy OCTINOXATE, OCTISALATE, OCTOCRYLENE, ENSULIZOLE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20100713 OTC MONOGRAPH FINAL part352 S+ ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 1.7; 7.5; 5; 1.7; .5; .6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 31720-102_f5ac0d35-c690-4658-a2b9-39df03072bb7 31720-102 HUMAN OTC DRUG Sephora Super Lisseur Rides SPF 15 Age Defy Moisture OCTINOXATE, OCTISALATE, OCTOCRYLENE, ENSULIZOLE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20120801 OTC MONOGRAPH FINAL part352 S+ ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 1.7; 7.5; 5; 1.7; .5; .6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 31720-201_30c03d24-74b6-479c-9a0f-4be7b39b8e16 31720-201 HUMAN OTC DRUG Sephora Super Lisseur Rides SPF 15 Age Defy Moisture ENSULIZOLE,OCTINOXATE, OCTISALATE, OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDE CREAM TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part352 S+ ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 17; 74.96; 50; 17; 4.5; 5.775 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 31720-202_29408644-bea4-4b3e-8d97-d2f552a800d7 31720-202 HUMAN OTC DRUG Sephora 8hr Mattifying Moisturizer Sunscreen Broad Spectrum SPF 20 AVOBENZONE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20121119 OTC MONOGRAPH FINAL part352 S+ AVOBENZONE; OCTINOXATE; OCTOCRYLENE 30; 75; 23.7 mg/mL; mg/mL; mg/mL 31720-203_6821ae4f-76b5-4f25-af79-727d94ed7335 31720-203 HUMAN OTC DRUG SEPHORA Acne-Fighting Roll-On SALICYLIC ACID GEL TOPICAL 20121112 OTC MONOGRAPH FINAL part333D S+ SALICYLIC ACID 20 mg/mL 31720-205_62d1f0c9-5afe-4db5-b7ba-e58111036f6f 31720-205 HUMAN OTC DRUG SEPHORA Skin Perfect CC Sunscreen Broad Spectrum SPF 20 FAIR TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130117 OTC MONOGRAPH FINAL part352 S+ TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL 31720-206_4237fdb3-483e-45f1-b447-8fd0be1b79f7 31720-206 HUMAN OTC DRUG SEPHORA Skin Perfect CC Sunscreen Broad Spectrum SPF 20 LIGHT TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130117 OTC MONOGRAPH FINAL part352 S+ TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL 31720-207_abf72776-3c96-43a0-8948-b94ac68d9439 31720-207 HUMAN OTC DRUG SEPHORA Skin Perfect CC Sunscreen Broad Spectrum SPF 20 MEDIUM TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130117 OTC MONOGRAPH FINAL part352 S+ TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL 31720-208_c478a3d6-b4df-4ce2-8331-5eb69384109e 31720-208 HUMAN OTC DRUG SEPHORA Skin Perfect CC Sunscreen Broad Spectrum SPF 20 MEDIUM-TAN TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130117 OTC MONOGRAPH FINAL part352 S+ TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL 31720-209_871c1478-c497-4067-8b47-d9a14ffa4612 31720-209 HUMAN OTC DRUG SEPHORA Skin Perfect CC Sunscreen Broad Spectrum SPF 20 TAN TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130117 OTC MONOGRAPH FINAL part352 S+ TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL 31720-210_2115ea68-2986-49c2-a2c2-043659b3ba3f 31720-210 HUMAN OTC DRUG SEPHORA Skin Perfect CC Sunscreen Broad Spectrum SPF 20 DARK TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130117 OTC MONOGRAPH FINAL part352 S+ TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL 31720-211_aea4a9ea-3caa-4dba-b5e5-b70192098e29 31720-211 HUMAN OTC DRUG SEPHORA Acne-Fighting Mattifying Moisturizer SALICYLIC ACID CREAM TOPICAL 20130117 OTC MONOGRAPH FINAL part333D S+ SALICYLIC ACID 20 mg/mL 31720-213_ab664452-95c9-4536-8c96-88ea1a656169 31720-213 HUMAN OTC DRUG SEPHORA Skin Perfect CC Sunscreen Broad Spectrum SPF 20 DEEP TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130117 OTC MONOGRAPH FINAL part352 S+ TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL 31720-302_e7ef6179-e6b7-4d3e-848f-935a55eac9bf 31720-302 HUMAN OTC DRUG SEPHORA Sunscreen Body Mist Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LIQUID TOPICAL 20130228 OTC MONOGRAPH NOT FINAL part352 S+ AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 12; 60; 20; 8; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 31720-303_d716b018-79cd-4f04-812a-04663d27fa85 31720-303 HUMAN OTC DRUG SEPHORA CC Care Color SPF 20 sunscreen OCTINOXATE, OXYBENZONE CREAM TOPICAL 20130606 OTC MONOGRAPH NOT FINAL part352 S+ OCTINOXATE; OXYBENZONE 75; 20 mg/mL; mg/mL 31720-408_dd99031b-e114-4cd1-815b-85094a0100e4 31720-408 HUMAN OTC DRUG SEPHORA Bronze Perfect CC sunscreen broad spectrum SPF 20 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140122 OTC MONOGRAPH NOT FINAL part352 S+ TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL 31722-200_29914956-c794-4806-b038-f0784b9db3d3 31722-200 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20070917 ANDA ANDA077222 Camber Pharmceuticals Inc. FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-201_29914956-c794-4806-b038-f0784b9db3d3 31722-201 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20070917 ANDA ANDA077222 Camber Pharmceuticals Inc. FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-202_29914956-c794-4806-b038-f0784b9db3d3 31722-202 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20070917 ANDA ANDA077222 Camber Pharmceuticals Inc. FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-206_84bfabf8-9e1d-4bd1-ade6-5a491296408e 31722-206 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 Camber Pharmaceuticals CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 31722-207_84bfabf8-9e1d-4bd1-ade6-5a491296408e 31722-207 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 Camber Pharmaceuticals CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 31722-208_84bfabf8-9e1d-4bd1-ade6-5a491296408e 31722-208 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 Camber Pharmaceuticals CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 31722-209_3a183255-d5c3-4a0f-92a9-91b8b51ab014 31722-209 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine TABLET ORAL 20110101 ANDA ANDA077533 Camber Pharmaceuticals TERBINAFINE HYDROCHLORIDE 250 1/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 31722-212_5616a898-fc8c-4bc5-87eb-62084fea396d 31722-212 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Camber Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 31722-213_5616a898-fc8c-4bc5-87eb-62084fea396d 31722-213 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Camber Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 31722-214_5616a898-fc8c-4bc5-87eb-62084fea396d 31722-214 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Camber Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 31722-218_c91afeb7-1f26-4fdc-b1d2-4a11f2e6a88b 31722-218 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20130801 ANDA ANDA090294 Camber Pharmaceutical, Inc. BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 31722-219_c91afeb7-1f26-4fdc-b1d2-4a11f2e6a88b 31722-219 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20130801 ANDA ANDA090294 Camber Pharmaceutical, Inc. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 31722-220_c91afeb7-1f26-4fdc-b1d2-4a11f2e6a88b 31722-220 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20130801 ANDA ANDA090294 Camber Pharmaceutical, Inc. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 31722-221_d73d94ff-1f19-4107-811a-9e5f78c105cf 31722-221 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Camber Pharmaceuticals Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 31722-222_d73d94ff-1f19-4107-811a-9e5f78c105cf 31722-222 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Camber Pharmaceuticals Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 31722-223_d73d94ff-1f19-4107-811a-9e5f78c105cf 31722-223 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Camber Pharmaceuticals Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 31722-225_fbfdad8d-c15c-4ded-9052-e1eb5734b2f6 31722-225 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20110101 ANDA ANDA077836 Camber Pharmaceuticals GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 31722-228_62729c28-3535-4195-9218-33a9039e4eae 31722-228 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20120221 ANDA ANDA077869 Camber Pharmaceuticals ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 31722-237_f37ff919-5ca3-4460-894b-0bbe0c7e8ac0 31722-237 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Camber Pharmaceuticals AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 31722-238_f37ff919-5ca3-4460-894b-0bbe0c7e8ac0 31722-238 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Camber Pharmaceuticals AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 31722-239_f37ff919-5ca3-4460-894b-0bbe0c7e8ac0 31722-239 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Camber Pharmaceuticals AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 31722-249_e280a343-4949-4c92-96f7-5744d8cf52c9 31722-249 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET ORAL 20120911 ANDA ANDA078604 Camber Pharmaceuticals ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 31722-250_e280a343-4949-4c92-96f7-5744d8cf52c9 31722-250 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET ORAL 20120911 ANDA ANDA078604 Camber Pharmaceuticals ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 31722-251_e280a343-4949-4c92-96f7-5744d8cf52c9 31722-251 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET ORAL 20120911 ANDA ANDA078604 Camber Pharmaceuticals ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 31722-256_46a8448f-fd60-4043-ae6a-512d67d50cc2 31722-256 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET ORAL 20140924 ANDA ANDA090842 Camber Pharmaceuticals Inc RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 31722-267_4f8f4cec-3b00-4a81-87ae-bbff99c7c69c 31722-267 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20120120 ANDA ANDA078457 Camber Pharmaceuticals QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-268_4f8f4cec-3b00-4a81-87ae-bbff99c7c69c 31722-268 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20120120 ANDA ANDA078457 Camber Pharmaceuticals QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-269_4f8f4cec-3b00-4a81-87ae-bbff99c7c69c 31722-269 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20120120 ANDA ANDA078457 Camber Pharmaceuticals QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-270_4f8f4cec-3b00-4a81-87ae-bbff99c7c69c 31722-270 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20120120 ANDA ANDA078457 Camber Pharmaceuticals QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-271_235c5540-0408-43d8-80bb-b8e31ed815e7 31722-271 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110101 ANDA ANDA078745 Camber Pharmaceuticals RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-272_235c5540-0408-43d8-80bb-b8e31ed815e7 31722-272 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110101 ANDA ANDA078745 Camber Pharmaceuticals RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-273_235c5540-0408-43d8-80bb-b8e31ed815e7 31722-273 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110101 ANDA ANDA078745 Camber Pharmaceuticals RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-274_235c5540-0408-43d8-80bb-b8e31ed815e7 31722-274 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110101 ANDA ANDA078745 Camber Pharmaceuticals RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-278_43e1322a-24ff-4bc9-be71-ac697a5be79d 31722-278 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Camber Pharmaceuticals TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 31722-279_43e1322a-24ff-4bc9-be71-ac697a5be79d 31722-279 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Camber Pharmaceuticals TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 31722-280_43e1322a-24ff-4bc9-be71-ac697a5be79d 31722-280 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Camber Pharmaceuticals TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 31722-281_43e1322a-24ff-4bc9-be71-ac697a5be79d 31722-281 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Camber Pharmaceuticals TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 31722-282_8b931a82-f7b1-4569-aff8-da927068ac39 31722-282 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120402 ANDA ANDA090478 Camber Pharmaceuticals CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 31722-283_8b931a82-f7b1-4569-aff8-da927068ac39 31722-283 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120402 ANDA ANDA090478 Camber Pharmaceuticals CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 31722-302_3fb33b8f-9ec4-4a4b-a520-de154673cfb0 31722-302 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride extended release Alfuzosin Hydrochloride TABLET ORAL 20120118 ANDA ANDA090284 Camber Pharmaceuticals ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 31722-327_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-327 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 31722-328_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-328 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 31722-329_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-329 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 31722-330_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-330 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 31722-331_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-331 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 31722-332_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-332 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 31722-333_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-333 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 31722-334_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-334 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 31722-335_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-335 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 31722-338_35bc8579-bca9-46a2-9303-5bcb760470d6 31722-338 HUMAN PRESCRIPTION DRUG Naproxen delayed release Naproxen TABLET ORAL 20120123 ANDA ANDA091432 Camber Pharmaceuticals NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 31722-339_35bc8579-bca9-46a2-9303-5bcb760470d6 31722-339 HUMAN PRESCRIPTION DRUG Naproxen delayed release Naproxen TABLET ORAL 20120123 ANDA ANDA091432 Camber Pharmaceuticals NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 31722-340_3466d710-2b9c-402a-9a88-a15411c974ed 31722-340 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20120123 ANDA ANDA091305 Camber Pharmaceuticals NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 31722-341_3466d710-2b9c-402a-9a88-a15411c974ed 31722-341 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20120123 ANDA ANDA091305 Camber Pharmaceuticals NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 31722-342_3466d710-2b9c-402a-9a88-a15411c974ed 31722-342 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20120123 ANDA ANDA091305 Camber Pharmaceuticals NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 31722-359_f8c27541-e9d7-4045-82f7-db4729db7273 31722-359 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20140402 ANDA ANDA202942 Camber Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 31722-374_d966e7b9-f6f0-4533-b06c-b6a54fcfacd0 31722-374 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET ORAL 20111215 ANDA ANDA201356 Camber Pharmaceuticals HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 31722-375_d966e7b9-f6f0-4533-b06c-b6a54fcfacd0 31722-375 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET ORAL 20111215 ANDA ANDA201356 Camber Pharmaceuticals HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 31722-376_d966e7b9-f6f0-4533-b06c-b6a54fcfacd0 31722-376 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET ORAL 20111215 ANDA ANDA201356 Camber Pharmaceuticals HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 31722-377_0cefa71a-1ab0-4e69-b6b6-b4070dd1e4b8 31722-377 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20140203 ANDA ANDA203135 Camber Pharmaceuticals, Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 31722-393_3af1f87c-2e11-47a7-8ace-719dafaac0be 31722-393 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate TABLET ORAL 20140203 ANDA ANDA202420 Camber Pharmaceuticals, Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 31722-405_7d574594-2035-49e6-889e-b5780000b9dc 31722-405 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20121029 ANDA ANDA202764 Camber Pharmaceuticals GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 31722-406_7d574594-2035-49e6-889e-b5780000b9dc 31722-406 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20121029 ANDA ANDA202764 Camber Pharmaceuticals GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 31722-417_7b73a793-a908-4c8e-94d9-3440626fc50c 31722-417 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20131115 ANDA ANDA203508 Camber Pharmaceuticals Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-418_7b73a793-a908-4c8e-94d9-3440626fc50c 31722-418 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20131115 ANDA ANDA203508 Camber Pharmaceuticals Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-419_7b73a793-a908-4c8e-94d9-3440626fc50c 31722-419 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20131115 ANDA ANDA203508 Camber Pharmaceuticals Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-420_7b73a793-a908-4c8e-94d9-3440626fc50c 31722-420 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20131115 ANDA ANDA203508 Camber Pharmaceuticals Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-421_7b73a793-a908-4c8e-94d9-3440626fc50c 31722-421 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20131115 ANDA ANDA203508 Camber Pharmaceuticals Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-422_7b73a793-a908-4c8e-94d9-3440626fc50c 31722-422 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20131115 ANDA ANDA203508 Camber Pharmaceuticals Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 31722-500_f7e527fe-2f67-45ad-a3ec-146ead819514 31722-500 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA040805 Camber Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 31722-501_f7e527fe-2f67-45ad-a3ec-146ead819514 31722-501 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA040805 Camber Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 31722-502_f7e527fe-2f67-45ad-a3ec-146ead819514 31722-502 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA040805 Camber Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 31722-505_3e00b0f9-06ee-4566-b909-e234159a1dbd 31722-505 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET ORAL 20120523 ANDA ANDA078584 Camber Pharmaceuticals, Inc. NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 31722-509_17d3e8e2-7532-48ea-aa17-cef1c947e516 31722-509 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET ORAL 20110101 ANDA ANDA090092 Camber Pharmaceuticals ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 31722-515_47401c88-8cae-4352-9942-94fbc43e856a 31722-515 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA078957 Camber Pharmaceuticals, Inc. STAVUDINE 15 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 31722-516_47401c88-8cae-4352-9942-94fbc43e856a 31722-516 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA078957 Camber Pharmaceuticals, Inc. STAVUDINE 20 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 31722-517_47401c88-8cae-4352-9942-94fbc43e856a 31722-517 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA078957 Camber Pharmaceuticals, Inc. STAVUDINE 30 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 31722-518_47401c88-8cae-4352-9942-94fbc43e856a 31722-518 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA078957 Camber Pharmaceuticals, Inc. STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 31722-519_0801cbcc-560f-48ae-9b56-86204079df4d 31722-519 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 Camber Pharmaceuticals HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 31722-520_0801cbcc-560f-48ae-9b56-86204079df4d 31722-520 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 Camber Pharmaceuticals HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 31722-521_0801cbcc-560f-48ae-9b56-86204079df4d 31722-521 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 Camber Pharmaceuticals HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 31722-522_0801cbcc-560f-48ae-9b56-86204079df4d 31722-522 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 Camber Pharmaceuticals HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 31722-525_e43e5797-ca46-4d98-a628-0efc7a2114d3 31722-525 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20130222 ANDA ANDA090061 Camber Pharmaceuticals, Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 31722-526_233d3c1d-37b2-4b5c-91d3-10d11a0b0e74 31722-526 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20130701 ANDA ANDA090060 Camber Pharmaceuticals, Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 31722-529_be7e52d8-efe4-4965-a69f-2b6a71aad296 31722-529 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110101 ANDA ANDA079234 Camber Pharmaceuticals, Inc. TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 31722-530_be7e52d8-efe4-4965-a69f-2b6a71aad296 31722-530 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110101 ANDA ANDA079234 Camber Pharmaceuticals, Inc. TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 31722-531_be7e52d8-efe4-4965-a69f-2b6a71aad296 31722-531 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110101 ANDA ANDA079234 Camber Pharmaceuticals, Inc. TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 31722-532_be7e52d8-efe4-4965-a69f-2b6a71aad296 31722-532 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110101 ANDA ANDA079234 Camber Pharmaceuticals, Inc. TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 31722-533_12fafa1f-a903-4046-a8f1-8ee030009cba 31722-533 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 Camber Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 31722-534_12fafa1f-a903-4046-a8f1-8ee030009cba 31722-534 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 Camber Pharmaceuticals, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 31722-536_2cd73426-cb79-46f7-a932-7d8056beb94a 31722-536 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120109 ANDA ANDA090515 Camber Pharmaceuticals LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 31722-537_2cd73426-cb79-46f7-a932-7d8056beb94a 31722-537 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120109 ANDA ANDA090515 Camber Pharmaceuticals LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 31722-538_2cd73426-cb79-46f7-a932-7d8056beb94a 31722-538 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120109 ANDA ANDA090515 Camber Pharmaceuticals LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 31722-539_2cd73426-cb79-46f7-a932-7d8056beb94a 31722-539 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120109 ANDA ANDA090515 Camber Pharmaceuticals LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 31722-542_8c496175-d88e-441f-bfd6-0b179ad0571f 31722-542 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 Camber Pharmaceuticals INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 31722-543_8c496175-d88e-441f-bfd6-0b179ad0571f 31722-543 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 Camber Pharmaceuticals INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 31722-544_646e3c3b-40e9-45bf-983f-e0f157cd3293 31722-544 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 Camber Pharmaceuticals Inc. LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] 31722-545_646e3c3b-40e9-45bf-983f-e0f157cd3293 31722-545 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 Camber Pharmaceuticals Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 31722-546_646e3c3b-40e9-45bf-983f-e0f157cd3293 31722-546 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 Camber Pharmaceuticals Inc. LITHIUM CARBONATE 600 mg/1 Mood Stabilizer [EPC] 31722-551_18537a1c-a3c0-4391-8904-963fc6e90aeb 31722-551 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET ORAL 20120629 ANDA ANDA091264 Camber Pharmaceuticals, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 31722-557_74cd7fb2-b91f-426f-9d19-62a8af820a0b 31722-557 HUMAN PRESCRIPTION DRUG Abacavir Abacavir TABLET ORAL 20130918 ANDA ANDA091560 Camber Pharmaceuticals, Inc. ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 31722-565_12f62bae-5fc0-4f8d-a8b4-446524bd53d1 31722-565 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20120928 ANDA ANDA201807 Camber Pharmaceuticals, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 31722-569_82d793ee-4039-45fc-ac83-4bd5235f00aa 31722-569 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate SOLUTION ORAL 20120612 ANDA ANDA202221 Camber Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 5 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 31722-574_12ac38df-434d-438e-a422-d4466a75c667 31722-574 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam Levetiracetam SOLUTION ORAL 20140529 ANDA ANDA203052 Camber Pharmaceuticals, Inc. LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 31722-706_08c58224-5920-4853-8c59-ec5fbb66c2f6 31722-706 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20140910 ANDA ANDA202438 Camber Pharmaceuticals, Inc. FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 31722-707_08c58224-5920-4853-8c59-ec5fbb66c2f6 31722-707 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20140910 ANDA ANDA202438 Camber Pharmaceuticals, Inc. FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 31722-708_08c58224-5920-4853-8c59-ec5fbb66c2f6 31722-708 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20140910 ANDA ANDA202438 Camber Pharmaceuticals, Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 31722-712_9daa1483-5a36-44db-9e0d-904d100da262 31722-712 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE TABLET, DELAYED RELEASE ORAL 20140910 ANDA ANDA202882 Camber Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 31722-713_9daa1483-5a36-44db-9e0d-904d100da262 31722-713 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE TABLET, DELAYED RELEASE ORAL 20140910 ANDA ANDA202882 Camber Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 31722-726_97a682c2-7e00-4d07-a5ac-4436c977f842 31722-726 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET, FILM COATED ORAL 20140910 ANDA ANDA202843 Camber Pharmaceuticals, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 31722-729_593f56ba-e527-4038-a5dc-cbd1602b4018 31722-729 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120926 ANDA ANDA202910 Camber Pharmaceuticals, Inc. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 31722-730_593f56ba-e527-4038-a5dc-cbd1602b4018 31722-730 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA202910 Camber Pharmaceuticals, Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 31722-731_593f56ba-e527-4038-a5dc-cbd1602b4018 31722-731 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA202910 Camber Pharmaceuticals, Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 31722-739_e816e8f5-1e50-4f49-8bea-92da0121d26e 31722-739 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20140206 ANDA ANDA203259 Camber Pharmaceuticals, Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 31722-752_6bd6b9da-df69-46db-813e-4e7f3bdecf95 31722-752 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20140102 ANDA ANDA203260 Camber Pharmaceuticals, Inc. LAMIVUDINE 100 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 31722-753_9d8acba3-74da-4c56-bbcf-c173dfbe8719 31722-753 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20140106 ANDA ANDA203277 Camber Pharmaceuticals, Inc. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 31722-754_9d8acba3-74da-4c56-bbcf-c173dfbe8719 31722-754 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20140106 ANDA ANDA203277 Camber Pharmaceuticals, Inc. LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 31722-776_f9415142-a5ac-45c0-a7c2-fb1fb6751f3d 31722-776 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20141126 ANDA ANDA203623 Camber Pharmaceuticals, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 31722-777_0910335b-6796-459f-b97e-d7ef5439a060 31722-777 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131129 ANDA ANDA203834 Camber Pharmaceuticals, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 31722-778_0910335b-6796-459f-b97e-d7ef5439a060 31722-778 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131129 ANDA ANDA203834 Camber Pharmaceuticals, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 31774-1018_fd6f35a4-5c60-4791-8138-ad6f851597ff 31774-1018 HUMAN OTC DRUG Thicker Fuller Hair - Dandruff Sulfate Free Salicylic Acid SHAMPOO TOPICAL 20131216 OTC MONOGRAPH FINAL part358F Golden Sun DBA Newhall Laboratories SALICYLIC ACID 18 mg/mL 32267-920_3d8f0f44-ed02-418b-87f9-eff6191df584 32267-920 HUMAN OTC DRUG Gy-Na-Tren Boric Acid, Lactobacillus Acidophilus, Vitamin C KIT 20120430 UNAPPROVED HOMEOPATHIC Natren Inc. 32472-102_0757f63f-91ad-4be7-b06d-228aa432df5c 32472-102 HUMAN OTC DRUG Analgesic menthol SPRAY TOPICAL 20110307 OTC MONOGRAPH NOT FINAL part348 Premiere Enterprises MENTHOL 700 mL/L 32472-102_ab98897a-cc1a-4844-88bc-f5077561e581 32472-102 HUMAN OTC DRUG Analgesic menthol SPRAY TOPICAL 20101228 OTC MONOGRAPH NOT FINAL part348 Premiere Enterprises MENTHOL 700 mL/L 32472-102_e309c8e7-eddb-4e65-afbf-c90b2d92833e 32472-102 HUMAN OTC DRUG Analgesic menthol SPRAY TOPICAL 20110112 OTC MONOGRAPH NOT FINAL part348 Premiere Enterprises MENTHOL 700 mL/L 32819-1001_a60ce300-e959-4adf-8ea4-18291070116e 32819-1001 HUMAN OTC DRUG SimmyungSaengMoSu Hair tonic ALPHA-TOCOPHEROL ACETATE LIQUID TOPICAL 20100902 UNAPPROVED DRUG OTHER Simmyung Pharmaceutical Co Ltd ALPHA-TOCOPHEROL ACETATE; NIACINAMIDE; SALICYLIC ACID 3; .45; .75 mL/150mL; mL/150mL; mL/150mL 32909-105_6ef787aa-dbd8-a2a8-583b-d2d2c4f50226 32909-105 HUMAN PRESCRIPTION DRUG Varibar Thin Liquid barium sulfate POWDER, FOR SUSPENSION ORAL 20020801 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE .81 g/g 32909-115_5e7045f7-b771-d8af-ce30-be95b2597c10 32909-115 HUMAN PRESCRIPTION DRUG Varibar Nectar barium sulfate SUSPENSION ORAL 20000601 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 400 mg/mL 32909-121_37bf7f08-5486-e570-7f80-0e0ee5cd33e8 32909-121 HUMAN PRESCRIPTION DRUG Varibar Thin Honey barium sulfate SUSPENSION ORAL 20050501 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 400 mg/mL 32909-122_d404b381-a180-4a85-6863-0a0d2bcabc52 32909-122 HUMAN PRESCRIPTION DRUG Varibar Honey barium sulfate SUSPENSION ORAL 20000601 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 400 mg/mL 32909-125_db75ddaf-9905-48cc-937e-056daa97bc60 32909-125 HUMAN PRESCRIPTION DRUG Varibar Pudding barium sulfate PASTE ORAL 20000601 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 400 mg/mL 32909-145_83a06a8e-93db-a59b-933c-5882127bce7c 32909-145 HUMAN PRESCRIPTION DRUG ENTERO Vu 24% barium sulfate SUSPENSION ORAL 20000930 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 240 mg/mL 32909-168_5b78c1b9-3013-4add-b439-663c419054b3 32909-168 HUMAN PRESCRIPTION DRUG Liquid Polibar Plus Barium Sulfate Suspension SUSPENSION ORAL; RECTAL 19840801 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 1.05 g/mL 32909-186_7a2f3919-1983-4eb8-bad5-93a6b2143ab9 32909-186 HUMAN PRESCRIPTION DRUG LIQUID E-Z-PAQUE barium sulfate SUSPENSION ORAL 19841101 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE .6 g/mL 32909-652_66837446-4d58-45c5-adee-b5932b06c182 32909-652 HUMAN PRESCRIPTION DRUG E-Z-Dose with Liquid Polibar Plus Barium Sulfate Suspension SUSPENSION RECTAL 19840801 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 1.05 g/mL 32909-715_ea5f629f-485d-ab17-15f5-45b06faa722c 32909-715 HUMAN PRESCRIPTION DRUG Readi-Cat2 Berry Smoothie Barium Sulfate SUSPENSION ORAL 20020201 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 21 mg/mL 32909-723_ea5f629f-485d-ab17-15f5-45b06faa722c 32909-723 HUMAN PRESCRIPTION DRUG Readi-Cat2 Barium Sulfate SUSPENSION ORAL 19850601 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 21 mg/mL 32909-725_ea5f629f-485d-ab17-15f5-45b06faa722c 32909-725 HUMAN PRESCRIPTION DRUG Readi-Cat2 Banana Smoothie Barium Sulfate SUSPENSION ORAL 19980801 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 21 mg/mL 32909-727_5ea0605b-2a9b-7bf0-fab2-454de4f1c9f0 32909-727 HUMAN PRESCRIPTION DRUG E-Z-Cat Dry Barium Sulfate POWDER, FOR SUSPENSION ORAL 19960101 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 9.5 g/23g 32909-755_ea5f629f-485d-ab17-15f5-45b06faa722c 32909-755 HUMAN PRESCRIPTION DRUG Readi-Cat2 Vanilla Smoothie Barium Sulfate SUSPENSION ORAL 20051101 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 21 mg/mL 32909-764_052f7cb3-6019-4f1c-acbd-3fcd3abf50fb 32909-764 HUMAN PRESCRIPTION DRUG E-Z-HD Barium Sulfate POWDER, FOR SUSPENSION ORAL 19800615 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 980 mg/g 32909-770_704132ea-4986-0b2c-2dd4-de89c0282a15 32909-770 HUMAN PRESCRIPTION DRUG E-Z-Paste Barium Sulfate CREAM ORAL 19740601 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE .6 g/g 32909-775_ea5f629f-485d-ab17-15f5-45b06faa722c 32909-775 HUMAN PRESCRIPTION DRUG Readi-Cat2 Mochaccino Smoothie Barium Sulfate SUSPENSION ORAL 20090331 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 21 mg/mL 32909-804_330cbb50-50ca-4251-b9c7-14e5fa89f7a8 32909-804 HUMAN PRESCRIPTION DRUG Polibar ACB BARIUM SULFATE POWDER, FOR SUSPENSION RECTAL 19780415 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 965 mg/g 32909-804_95ecf68c-9449-4a8b-bfe9-91e34d506f58 32909-804 HUMAN PRESCRIPTION DRUG Polibar ACB BARIUM SULFATE POWDER, FOR SUSPENSION RECTAL 19780415 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 965 mg/g 32909-814_30c68756-c7db-bf50-9cd5-ef4b0c7ab1d0 32909-814 HUMAN PRESCRIPTION DRUG Tagitol V barium sulfate SUSPENSION ORAL 20031101 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 400 mg/mL 32909-945_0edb179d-5b32-3596-a25b-39cf996f8076 32909-945 HUMAN PRESCRIPTION DRUG VoLumen Barium Sulfate SUSPENSION ORAL 20031101 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 1 mg/mL 33217-001_98d24085-4d2d-403c-8d95-2150472774a2 33217-001 HUMAN OTC DRUG CHING WAN HUNG SOOTHING HERBAL BALM MENTHOL OINTMENT TOPICAL 20120812 OTC MONOGRAPH NOT FINAL part348 TIANJIN DARENTANG JINGWANHONG PHARMACEUTICAL CO., LTD. MENTHOL 1 g/100g 33237-001_0c72f6c3-354c-4fc8-bcd8-d9edd7e7d8a5 33237-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070401 NDA NDA205840 Airgas Merchant Gases, LLC OXYGEN 990 mL/L 33237-002_a006196e-64ad-4a31-be4e-38882257ce96 33237-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20070401 NDA NDA205839 Airgas Merchant Gases, LLC NITROGEN 990 mL/L 33261-001_52b8a439-688c-43db-bfea-a773b81a2157 33261-001 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 33261-002_52b8a439-688c-43db-bfea-a773b81a2157 33261-002 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089828 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 33261-004_93729350-108f-4474-811d-9e4ca0294eac 33261-004 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Aidarex Pharmaceuticals LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 33261-005_93729350-108f-4474-811d-9e4ca0294eac 33261-005 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Aidarex Pharmaceuticals LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 33261-007_3b66c2f6-3d9f-4bc4-bad4-c6736f1d45e7 33261-007 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aidarex Pharmaceuticals LLC AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 33261-010_c3489764-d9f9-4d2a-ab7f-3c3bfa652af7 33261-010 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077156 Aidarex Pharmaceuticals LLC BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 33261-011_c3489764-d9f9-4d2a-ab7f-3c3bfa652af7 33261-011 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077068 Aidarex Pharmaceuticals LLC BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 33261-012_b5db0a4b-286e-42a7-accc-70fc84efeaa7 33261-012 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Aidarex Pharmaceuticals LLC BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 33261-013_b5db0a4b-286e-42a7-accc-70fc84efeaa7 33261-013 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Aidarex Pharmaceuticals LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 33261-014_33365e8c-5579-4254-aac1-04601d46cec7 33261-014 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020228 ANDA ANDA075022 Aidarex Pharmaceuticals LLC BUSPIRONE HYDROCHLORIDE 10 mg/1 33261-015_33365e8c-5579-4254-aac1-04601d46cec7 33261-015 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020301 ANDA ANDA075022 Aidarex Pharmaceuticals LLC BUSPIRONE HYDROCHLORIDE 15 mg/1 33261-018_6b12226c-28cd-4448-9b95-242fd0cc761e 33261-018 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20080423 ANDA ANDA065392 Aidarex Pharmaceuticals LLC CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 33261-019_bcb89362-3e1a-41ed-ba17-d740662897e0 33261-019 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Aidarex Pharmaceuticals LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-020_9e4f9fd2-cd74-4527-8b28-4688f72cdf6f 33261-020 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Aidarex Pharmaceuticals LLC CEPHALEXIN ANHYDROUS 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 33261-021_a9dbb759-844a-4b12-9fe5-c08c041c49b6 33261-021 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822 ANDA ANDA089859 Aidarex Pharmaceuticals LLC CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 33261-024_d122e35a-08d1-441b-8a9d-b9b99ddcab9e 33261-024 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20040202 ANDA ANDA074151 Aidarex Pharmaceuticals LLC CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 33261-026_11d5faa0-145f-45b8-a386-b17d0ef240d0 33261-026 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Aidarex Pharmaceuticals LLC CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-027_11d5faa0-145f-45b8-a386-b17d0ef240d0 33261-027 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Aidarex Pharmaceuticals LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-028_11d5faa0-145f-45b8-a386-b17d0ef240d0 33261-028 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Aidarex Pharmaceuticals LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-029_8fa29043-847f-4835-b929-70ac0e139880 33261-029 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Aidarex Pharmaceuticals LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 33261-033_1b891b2e-c23a-44cf-8d4e-4d26dd070023 33261-033 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100218 ANDA ANDA078218 Aidarex Pharmaceuticals LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 33261-034_1288f851-da84-40fb-9b2c-d50c826fe791 33261-034 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Aidarex Pharmaceuticals LLC DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 33261-035_1288f851-da84-40fb-9b2c-d50c826fe791 33261-035 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Aidarex Pharmaceuticals LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 33261-038_86cb1755-1ee1-46a2-8db0-4c573a5dbc9f 33261-038 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19980811 ANDA ANDA075219 Aidarex Pharmaceuticals LLC DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-039_67a1c308-26ed-4150-8e1e-21c9d07d220f 33261-039 HUMAN OTC DRUG Non-Habit Forming Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120329 OTC MONOGRAPH NOT FINAL part334 Aidarex Pharmaceuticals LLC DOCUSATE SODIUM 100 mg/1 33261-043_f67ac41b-c0aa-4443-8468-fc7e2f975da7 33261-043 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980520 ANDA ANDA075009 Aidarex Pharmaceuticals LLC ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-044_f67ac41b-c0aa-4443-8468-fc7e2f975da7 33261-044 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20090909 ANDA ANDA075009 Aidarex Pharmaceuticals LLC ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-045_ca0dc511-15a7-4911-a012-ad975bfc34d3 33261-045 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Aidarex Pharmaceuticals LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-048_aeb1540b-a797-44b1-9964-28ddfba18b4f 33261-048 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Aidarex Pharmaceuticals LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33261-049_aeb1540b-a797-44b1-9964-28ddfba18b4f 33261-049 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Aidarex Pharmaceuticals LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33261-050_aeb1540b-a797-44b1-9964-28ddfba18b4f 33261-050 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Aidarex Pharmaceuticals LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33261-051_0756b645-0741-4473-b777-7ee472358140 33261-051 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111006 ANDA ANDA200651 Aidarex Pharmaceuticals LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33261-053_8ba67275-a748-4be8-8398-f76b900c2daa 33261-053 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 33261-054_8ba67275-a748-4be8-8398-f76b900c2daa 33261-054 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19881202 ANDA ANDA089971 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 33261-055_8ba67275-a748-4be8-8398-f76b900c2daa 33261-055 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 33261-056_8ba67275-a748-4be8-8398-f76b900c2daa 33261-056 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19960222 ANDA ANDA040144 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 33261-057_8ba67275-a748-4be8-8398-f76b900c2daa 33261-057 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19960412 ANDA ANDA040157 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 33261-058_8ba67275-a748-4be8-8398-f76b900c2daa 33261-058 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 33261-060_06f5fb33-7f65-4bc8-bbaf-be11626de267 33261-060 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19940816 ANDA ANDA072096 Aidarex Pharmaceuticals LLC IBUPROFEN 200 mg/1 33261-061_f3c660d7-4795-4f28-bc87-7a97a6b3c256 33261-061 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Aidarex Pharmaceuticals LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-062_f3c660d7-4795-4f28-bc87-7a97a6b3c256 33261-062 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Aidarex Pharmaceuticals LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-064_db694f6b-8c95-4f66-9b6e-5ab64d416abe 33261-064 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101 ANDA ANDA073517 Aidarex Pharmaceuticals LLC KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-065_5a527655-75fd-42b8-b724-ff24d527a240 33261-065 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 19980617 ANDA ANDA074754 Aidarex Pharmaceuticals LLC KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-068_42ce3852-92b2-4637-89cf-a85b2e106ccf 33261-068 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Aidarex Pharmaceuticals LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 33261-069_42ce3852-92b2-4637-89cf-a85b2e106ccf 33261-069 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Aidarex Pharmaceuticals LLC LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 33261-070_c077af4d-7cae-43da-8004-768284bda2dd 33261-070 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Aidarex Pharmaceuticals LLC MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-071_c077af4d-7cae-43da-8004-768284bda2dd 33261-071 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Aidarex Pharmaceuticals LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-072_db596a36-5f82-4d41-a563-e583eb355e56 33261-072 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Aidarex Pharmaceuticals LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 33261-073_c25beec4-de6c-4516-a172-f7408248831a 33261-073 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Aidarex Pharmaceuticals LLC MIRTAZAPINE 15 mg/1 33261-074_96a2c79d-af3b-44d6-8894-7483dc3e2139 33261-074 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076312 Aidarex Pharmaceuticals LLC MIRTAZAPINE 30 mg/1 33261-076_384c955d-a727-43b5-be9e-3e6f501cf2d3 33261-076 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 Aidarex Pharmaceuticals LLC MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 33261-077_856e729d-1c5e-40d8-96e6-90b1e3cf43c9 33261-077 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20110613 ANDA ANDA091083 Aidarex Pharmaceuticals LLC NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-078_b3102c1a-a63f-480c-9391-99669c295f7f 33261-078 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Aidarex Pharmaceuticals LLC NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-079_8ec413d7-65e0-4019-a2bc-7b8ebb2e7824 33261-079 HUMAN OTC DRUG good sense all day pain relief Naproxen Sodium TABLET ORAL 19970114 ANDA ANDA074661 Aidarex Pharmaceuticals LLC NAPROXEN SODIUM 220 mg/1 33261-080_7e3dcdf1-4ba5-458d-b4e1-20ab4e9dda2b 33261-080 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Aidarex Pharmaceuticals LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-081_4ac8c61d-66f2-49f0-959f-7f2a92137a61 33261-081 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Aidarex Pharmaceuticals LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-082_c4e5a877-72fc-4cd7-9492-905e8df337d8 33261-082 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 19980731 ANDA ANDA075227 Aidarex Pharmaceuticals LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-083_c4e5a877-72fc-4cd7-9492-905e8df337d8 33261-083 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 19980729 ANDA ANDA075227 Aidarex Pharmaceuticals LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-084_f67ff8f9-fff1-4cd4-abc6-819b577837dc 33261-084 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Aidarex Pharmaceuticals LLC NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-085_f67ff8f9-fff1-4cd4-abc6-819b577837dc 33261-085 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Aidarex Pharmaceuticals LLC NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-087_884283f6-ff17-45e2-8452-731609251271 33261-087 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Aidarex Pharmaceuticals LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 33261-088_2076f538-fb8b-4bbb-aaff-c50a32e92d07 33261-088 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Aidarex Pharmaceuticals LLC ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 33261-090_847c3a3f-7716-462c-a7f3-481e3501876b 33261-090 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Aidarex Pharmaceuticals LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-091_847c3a3f-7716-462c-a7f3-481e3501876b 33261-091 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Aidarex Pharmaceuticals LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-099_aa25a817-e7ed-4ec7-9a59-235d9277ff84 33261-099 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Aidarex Pharmaceuticals LLC RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 33261-100_3aa87574-73f6-487c-9e06-6f5b348b38dc 33261-100 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20100125 ANDA ANDA072711 Aidarex Pharmaceuticals LLC SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-103_9b79e6bb-62f1-473c-ac30-3dba1a23384d 33261-103 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Aidarex Pharmaceuticals LLC TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 33261-104_9b79e6bb-62f1-473c-ac30-3dba1a23384d 33261-104 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Aidarex Pharmaceuticals LLC TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 33261-105_1dcbca44-a8e9-47a2-8c61-2758dd586a83 33261-105 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 Aidarex Pharmaceuticals LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 33261-106_e1c475c2-3437-4249-af16-1f9142ff1941 33261-106 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Aidarex Pharmaceuticals LLC TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33261-107_ed1631ee-9ac0-4936-9749-e6be6ef1aa44 33261-107 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 Aidarex Pharmaceuticals LLC TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 33261-109_0a6cb56c-0b44-45d8-8538-ca16e678ab9b 33261-109 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Aidarex Pharmaceuticals LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 33261-110_e65cb52f-902e-46f2-bf7c-05aa73ef281e 33261-110 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Aidarex Pharmaceuticals LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 33261-111_6c362672-6199-4377-a903-2eb110e836fb 33261-111 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 33261-112_6c362672-6199-4377-a903-2eb110e836fb 33261-112 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065101 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 33261-116_0756b645-0741-4473-b777-7ee472358140 33261-116 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111006 ANDA ANDA200651 Aidarex Pharmaceuticals LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33261-117_884283f6-ff17-45e2-8452-731609251271 33261-117 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Aidarex Pharmaceuticals LLC OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 33261-128_4ac8c61d-66f2-49f0-959f-7f2a92137a61 33261-128 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Aidarex Pharmaceuticals LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-129_3c78a73d-80ef-4a71-8aeb-a101196947e6 33261-129 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 Aidarex Pharmaceuticals LLC PREDNISONE 20 mg/1 33261-130_db596a36-5f82-4d41-a563-e583eb355e56 33261-130 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Aidarex Pharmaceuticals LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 33261-131_d3cfec5b-8dfb-4138-8ee0-09bf49a5c38e 33261-131 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20120717 ANDA ANDA040712 Aidarex Pharmaceuticals LLC PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CIV 33261-132_145b4e74-3442-4d9c-81b7-f71fe7401332 33261-132 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Aidarex Pharmaceuticals LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 33261-134_65666c2b-4095-4d95-b941-e5ef4956474c 33261-134 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062936 Aidarex Pharmaceuticals LLC PENICILLIN V POTASSIUM 250 mg/1 33261-137_d4fa5d57-edb5-4dc5-94a0-5cd9bddc9dcd 33261-137 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 Aidarex Pharmaceuticals LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 33261-138_65666c2b-4095-4d95-b941-e5ef4956474c 33261-138 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062935 Aidarex Pharmaceuticals LLC PENICILLIN V POTASSIUM 500 mg/1 33261-141_b6201f98-9bd5-4cde-87b6-750478ff74ae 33261-141 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine Maleate TABLET ORAL 19980301 ANDA ANDA040268 Aidarex Pharmaceuticals LLC PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 33261-142_1af6f684-9c87-4b46-bb20-cce0769174bf 33261-142 HUMAN OTC DRUG Mapap ACETAMINOPHEN TABLET ORAL 20110421 OTC MONOGRAPH FINAL part343 Aidarex Pharmaceuticals LLC ACETAMINOPHEN 325 mg/1 33261-143_d2bb7fc7-fb5c-4aee-b764-58cbe04933db 33261-143 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 Aidarex Pharmaceuticals LLC DOXYCYCLINE HYCLATE 100 mg/1 33261-144_d4fa5d57-edb5-4dc5-94a0-5cd9bddc9dcd 33261-144 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 Aidarex Pharmaceuticals LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 33261-145_01865cdb-07be-4125-8bd9-6e4c61f5f0f8 33261-145 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Aidarex Pharmaceuticals LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 33261-146_08efe152-6ce2-477a-9b41-0b3fe7abb8eb 33261-146 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19981001 ANDA ANDA075034 Aidarex Pharmaceuticals LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 33261-147_5e2ff1d2-363a-41a0-b6ac-8ced16c6fb7b 33261-147 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Aidarex Pharmaceuticals LLC BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 33261-148_927a9937-2723-496c-ad8d-5b4ddcad446c 33261-148 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Aidarex Pharmaceuticals LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 33261-149_9e4f9fd2-cd74-4527-8b28-4688f72cdf6f 33261-149 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Aidarex Pharmaceuticals LLC CEPHALEXIN ANHYDROUS 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 33261-150_145b4e74-3442-4d9c-81b7-f71fe7401332 33261-150 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Aidarex Pharmaceuticals LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 33261-151_72aa6c88-0bac-469c-a1d8-4433c4f926b2 33261-151 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840507 ANDA ANDA062396 Aidarex Pharmaceuticals LLC DOXYCYCLINE HYCLATE 100 mg/1 33261-152_896b0412-3ac7-470f-b96c-b3a6b50cf6a1 33261-152 HUMAN OTC DRUG Adult Low Dose Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20070112 OTC MONOGRAPH FINAL part343 Aidarex Pharmaceuticals LLC ASPIRIN 81 mg/1 33261-153_0d38a94d-5641-4615-96ee-28363bda0515 33261-153 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH FINAL part343 Aidarex Pharmaceuticals LLC ASPIRIN 325 mg/1 33261-155_f3c660d7-4795-4f28-bc87-7a97a6b3c256 33261-155 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Aidarex Pharmaceuticals LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33261-157_14425971-c3fa-42df-b5bc-f2406863729b 33261-157 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Aidarex Pharmaceuticals LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 33261-158_be013517-42af-4118-8ae1-b35b8ea34684 33261-158 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33261-159_8eb8b8e7-e935-4074-8a7a-d1e9116fd6f6 33261-159 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Aidarex Pharmaceuticals LLC CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 33261-160_287b7aba-b3e7-4a98-ac8b-474f17157b0e 33261-160 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 Aidarex Pharmaceuticals LLC NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 33261-163_265be229-6d0b-4ceb-a94a-7f84ca2c3141 33261-163 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19990226 ANDA ANDA040230 Aidarex Pharmaceuticals LLC DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 33261-164_da202d5d-414e-42a2-8a90-e20c90b0afec 33261-164 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Aidarex Pharmaceuticals LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 33261-166_9f5ed975-8bb7-4b71-af13-292cbd830a24 33261-166 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 Aidarex Pharmaceuticals LLC METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 33261-170_2e6b8fbe-b434-4564-9587-c81e3a758345 33261-170 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Aidarex Pharmaceuticals LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-171_2e6b8fbe-b434-4564-9587-c81e3a758345 33261-171 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Aidarex Pharmaceuticals LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-172_a1bad093-8e73-403e-a4b7-f7fede4451d9 33261-172 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Aidarex Pharmaceuticals LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 33261-173_a1bad093-8e73-403e-a4b7-f7fede4451d9 33261-173 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Aidarex Pharmaceuticals LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 33261-174_8e5a1b85-9468-4dc3-94b8-06cda657d5b3 33261-174 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Aidarex Pharmaceuticals LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 33261-178_78f88be7-cf2a-457c-b2ab-3a9144283384 33261-178 HUMAN OTC DRUG Enteric Coated Stimulant Laxative Bisacodyl TABLET, DELAYED RELEASE ORAL 20110922 OTC MONOGRAPH NOT FINAL part334 Aidarex Pharmaceuticals LLC BISACODYL 5 mg/1 33261-179_2e92a75c-ab99-49b1-8033-efbbcace2d68 33261-179 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Aidarex Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 33261-180_2e92a75c-ab99-49b1-8033-efbbcace2d68 33261-180 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Aidarex Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 33261-182_b01ba900-3657-4093-875f-11c5140561a3 33261-182 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Aidarex Pharmaceuticals LLC CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 33261-183_8b3d55d1-6227-4214-8b25-fa39a072fcc7 33261-183 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Aidarex Pharmaceuticals LLC DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 33261-184_aa7a0856-d32b-4ddb-a71f-79cf29c9811e 33261-184 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Aidarex Pharmaceuticals LLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-185_3a7c6910-e16c-4c50-8028-4f58aca0010b 33261-185 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Aidarex Pharmaceuticals LLC FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 33261-202_aa25a817-e7ed-4ec7-9a59-235d9277ff84 33261-202 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Aidarex Pharmaceuticals LLC RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 33261-209_fea6f761-235f-4d3d-99c6-6389070ec7d9 33261-209 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Aidarex Pharmaceuticals LLC GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 33261-211_ce7c1472-b399-493e-a419-e71701b04acc 33261-211 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20010412 ANDA ANDA075498 Aidarex Pharmaceuticals LLC TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 33261-212_ce7c1472-b399-493e-a419-e71701b04acc 33261-212 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20010412 ANDA ANDA075498 Aidarex Pharmaceuticals LLC TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 33261-215_2db171f2-8e66-4b37-a0d4-ce781a9f87f7 33261-215 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Aidarex Pharmaceuticals LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 33261-218_8ba67275-a748-4be8-8398-f76b900c2daa 33261-218 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040356 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 33261-220_e821edd9-cd2c-4f50-92a2-ab13a5823e86 33261-220 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Aidarex Pharmaceuticals LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 33261-222_41a6f20f-8d1b-4f11-9618-d6b70ef073d9 33261-222 HUMAN OTC DRUG Allergy Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Aidarex Pharmaceuticals LLC CHLORPHENIRAMINE MALEATE 4 mg/1 33261-224_99e2903e-bc3a-4829-ac6b-f78731ee704f 33261-224 HUMAN OTC DRUG Mi-Acid Gas Relief Simethicone TABLET, CHEWABLE ORAL 20110302 OTC MONOGRAPH FINAL part332 Aidarex Pharmaceuticals LLC DIMETHICONE 80 mg/1 33261-226_9d53dbae-d850-4c5b-b602-365135ceb487 33261-226 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Aidarex Pharmaceuticals LLC NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 33261-227_7a30fb41-2a84-4afb-a155-46dba2cfb76a 33261-227 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970430 ANDA ANDA074556 Aidarex Pharmaceuticals LLC ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 33261-228_733d75a7-5111-47b2-a8c2-879fca5993c6 33261-228 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110422 ANDA ANDA076447 Aidarex Pharmaceuticals LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 33261-229_47349194-fbe8-4176-86f2-67454764c301 33261-229 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 Aidarex Pharmaceuticals LLC FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 33261-332_0a6cb56c-0b44-45d8-8538-ca16e678ab9b 33261-332 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Aidarex Pharmaceuticals LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 33261-335_09135c69-fdaa-4452-a8d4-81cff1a36ceb 33261-335 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 Aidarex Pharmaceuticals LLC METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 33261-336_dc4501f9-c70f-46c1-811b-d72fdc4af22c 33261-336 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Aidarex Pharmaceuticals LLC PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 33261-337_44cce19f-c8c1-4ec3-bc37-7d90521f0d99 33261-337 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Aidarex Pharmaceuticals LLC LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 33261-340_8fa29043-847f-4835-b929-70ac0e139880 33261-340 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Aidarex Pharmaceuticals LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 33261-341_2ab0e38c-de77-4f37-a0c5-c99aac1aac78 33261-341 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 Aidarex Pharmaceuticals LLC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 33261-342_3f4d9011-13a0-4ec4-a343-75ff90e9782f 33261-342 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 19971031 ANDA ANDA075079 Aidarex Pharmaceuticals LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 33261-344_c11a6272-a3e1-4962-83ca-17bdb3e966c5 33261-344 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA073192 Aidarex Pharmaceuticals LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 33261-346_c6cd640f-0dd1-4c1c-bd96-6d1aa77a0c63 33261-346 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Aidarex Pharmaceuticals LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-348_7f8fad0a-267b-4284-9de3-14ddd77d9ac0 33261-348 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950406 ANDA ANDA074132 Aidarex Pharmaceuticals LLC NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 33261-349_e821edd9-cd2c-4f50-92a2-ab13a5823e86 33261-349 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Aidarex Pharmaceuticals LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 33261-351_3c78a73d-80ef-4a71-8aeb-a101196947e6 33261-351 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Aidarex Pharmaceuticals LLC PREDNISONE 5 mg/1 33261-352_3c78a73d-80ef-4a71-8aeb-a101196947e6 33261-352 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Aidarex Pharmaceuticals LLC PREDNISONE 10 mg/1 33261-353_9af69fd4-964e-4666-88da-0bc5697e11c1 33261-353 HUMAN PRESCRIPTION DRUG DIETHYLPROPION HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE TABLET ORAL 20101227 ANDA ANDA201212 Aidarex Pharmaceuticals LLC DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 33261-354_55fa3e3c-536a-4fba-8006-86f392a23ce7 33261-354 HUMAN PRESCRIPTION DRUG Diethylpropion HydrochlorideER ER Diethylpropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111024 ANDA ANDA091680 Aidarex Pharmaceuticals LLC DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 33261-355_fffb5cb3-6568-4027-80b4-8bd01a4769ce 33261-355 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aidarex Pharmaceuticals LLC WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 33261-356_fffb5cb3-6568-4027-80b4-8bd01a4769ce 33261-356 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aidarex Pharmaceuticals LLC WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 33261-357_fffb5cb3-6568-4027-80b4-8bd01a4769ce 33261-357 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aidarex Pharmaceuticals LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 33261-358_3b66c2f6-3d9f-4bc4-bad4-c6736f1d45e7 33261-358 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aidarex Pharmaceuticals LLC AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 33261-361_5f577a31-f2d5-4439-88be-f3cac906776c 33261-361 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 Aidarex Pharmaceuticals LLC PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 33261-363_3b66c2f6-3d9f-4bc4-bad4-c6736f1d45e7 33261-363 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aidarex Pharmaceuticals LLC AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 33261-364_42ce3852-92b2-4637-89cf-a85b2e106ccf 33261-364 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Aidarex Pharmaceuticals LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 33261-366_5f577a31-f2d5-4439-88be-f3cac906776c 33261-366 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040875 Aidarex Pharmaceuticals LLC PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 33261-367_da202d5d-414e-42a2-8a90-e20c90b0afec 33261-367 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Aidarex Pharmaceuticals LLC CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 33261-372_7051a1a4-226c-4a41-b5d3-0f666740855b 33261-372 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091202 ANDA ANDA078596 Aidarex Pharmaceuticals LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 33261-373_2cddca79-12fd-478f-a173-9f43803be9e1 33261-373 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Aidarex Pharmaceuticals LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 33261-374_8e5a1b85-9468-4dc3-94b8-06cda657d5b3 33261-374 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Aidarex Pharmaceuticals LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 33261-376_2c5e9aab-f400-47be-ab36-e1b3f055f249 33261-376 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020410 ANDA ANDA075604 Aidarex Pharmaceuticals LLC POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 33261-378_f16db661-9faa-4340-84f9-acf1497b5d15 33261-378 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED ORAL 20040401 ANDA ANDA076604 Aidarex Pharmaceuticals LLC HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 33261-379_8ba67275-a748-4be8-8398-f76b900c2daa 33261-379 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19970414 ANDA ANDA040155 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 33261-384_351fe213-7c9c-4d7e-a68e-3d6b84c663ca 33261-384 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110822 ANDA ANDA070044 Aidarex Pharmaceuticals LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 33261-385_ed1631ee-9ac0-4936-9749-e6be6ef1aa44 33261-385 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071524 Aidarex Pharmaceuticals LLC TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 33261-386_ed1631ee-9ac0-4936-9749-e6be6ef1aa44 33261-386 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071525 Aidarex Pharmaceuticals LLC TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 33261-387_8b551ae6-9f3a-4ff2-b62d-e74d5e6fe9a0 33261-387 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20100830 ANDA ANDA040124 Aidarex Pharmaceuticals LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 33261-389_055f642c-a10c-4209-812b-d9f3c1a7816e 33261-389 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 33261-390_a815119a-0cf9-4dfd-9c17-aa9af6e52585 33261-390 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate CAPSULE, EXTENDED RELEASE ORAL 19770906 NDA NDA018074 Aidarex Pharmaceuticals LLC PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 33261-391_bbb202cc-8929-4ad4-bb03-3737038a6e4e 33261-391 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20060131 ANDA ANDA040650 Aidarex Pharmaceuticals LLC CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 33261-393_18da72cf-bc71-46c3-a184-f99740bf8d7d 33261-393 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Aidarex Pharmaceuticals LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 33261-396_a3ab3a35-a130-4804-9ad8-0d733c7a8d48 33261-396 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100225 ANDA ANDA076899 Aidarex Pharmaceuticals LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 33261-397_c5e4b51a-8b09-4030-8221-7de9183d4110 33261-397 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 Aidarex Pharmaceuticals LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 33261-399_da202d5d-414e-42a2-8a90-e20c90b0afec 33261-399 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Aidarex Pharmaceuticals LLC CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 33261-400_bb2afcb1-4412-4841-a449-7feff8f10da0 33261-400 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Aidarex Pharmaceuticals LLC TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33261-403_335dec43-2c8b-4432-81e1-f9284a7a834f 33261-403 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 Aidarex Pharmaceuticals LLC AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 33261-408_de1b0250-3018-48a3-a7f3-49639679a086 33261-408 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120815 ANDA ANDA040887 Aidarex Pharmaceuticals LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 33261-413_433935fb-4377-4c68-9fd8-b127bf281095 33261-413 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20080722 OTC MONOGRAPH FINAL part336 Aidarex Pharmaceuticals LLC MECLIZINE HYDROCHLORIDE 25 mg/1 33261-415_a981e42c-0e19-4340-bf9e-eb489d691fe7 33261-415 HUMAN PRESCRIPTION DRUG Antipyrine and Benzocaine Antipyrine and Benzocaine SOLUTION AURICULAR (OTIC) 19900930 UNAPPROVED DRUG OTHER Aidarex Pharmaceuticals LLC ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 33261-416_76932243-b0df-474c-aa58-b41c89d051d7 33261-416 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060410 ANDA ANDA077912 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 33261-417_1156d9cb-4ad2-49c0-b7ee-4b947c5dcc84 33261-417 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Aidarex Pharmaceuticals LLC ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 33261-419_7a30fb41-2a84-4afb-a155-46dba2cfb76a 33261-419 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 19970423 ANDA ANDA074578 Aidarex Pharmaceuticals LLC ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 33261-433_c5e4b51a-8b09-4030-8221-7de9183d4110 33261-433 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 Aidarex Pharmaceuticals LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 33261-434_b467b2f6-9ecd-45be-a714-664764233d01 33261-434 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Aidarex Pharmaceuticals LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 33261-437_0d247451-52f8-45ba-a1ec-91401605c8d0 33261-437 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Aidarex Pharmaceuticals LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 33261-441_69e110c7-961b-433f-ab96-cd1c4c739c78 33261-441 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Aidarex Pharmaceuticals LLC OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 33261-448_8eb8b8e7-e935-4074-8a7a-d1e9116fd6f6 33261-448 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Aidarex Pharmaceuticals LLC CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 33261-449_06831b0d-ae6e-45d0-bd17-955ab16c31d3 33261-449 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR (SR) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120515 ANDA ANDA201331 Aidarex Pharmaceuticals LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 33261-454_102c0c6c-be48-40e6-8299-031e8f3dc843 33261-454 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Aidarex Pharmaceuticals LLC ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 33261-458_9f37c87d-020c-4e5c-b3b9-dfae7d38ae62 33261-458 HUMAN PRESCRIPTION DRUG BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET ORAL 20100721 ANDA ANDA090968 Aidarex Pharmaceuticals LLC BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 33261-459_3b66c2f6-3d9f-4bc4-bad4-c6736f1d45e7 33261-459 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aidarex Pharmaceuticals LLC AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 33261-460_02811f2f-f4d1-44c0-9ba3-f8dcba5c3cf3 33261-460 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 Aidarex Pharmaceuticals LLC AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 33261-463_12a87643-479a-4a6c-b307-646c58aa89f6 33261-463 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Aidarex Pharmaceuticals LLC AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 33261-464_7ba622bc-fa2c-4ed8-a06d-c545253f39f5 33261-464 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 33261-470_86859de8-6f89-477b-8e5a-c9634bb99693 33261-470 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate ACETAMINOPHEN and CODEINE PHOSPHATE SOLUTION ORAL 19810821 ANDA ANDA087508 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 33261-471_de1b0250-3018-48a3-a7f3-49639679a086 33261-471 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120815 ANDA ANDA040876 Aidarex Pharmaceuticals LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 33261-475_168364de-3c99-4692-8485-c0a196d3ce18 33261-475 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 19981211 ANDA ANDA089081 Aidarex Pharmaceuticals LLC PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 33261-480_bb2afcb1-4412-4841-a449-7feff8f10da0 33261-480 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Aidarex Pharmaceuticals LLC TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33261-483_5e9ad922-f27b-413e-9b11-a1a649e4c695 33261-483 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 Aidarex Pharmaceuticals LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 33261-484_8f650da9-045b-49b9-936b-c0861a2b9505 33261-484 HUMAN PRESCRIPTION DRUG Antipyrine and Benzocaine Antipyrine and Benzocaine SOLUTION AURICULAR (OTIC) 20090430 UNAPPROVED DRUG OTHER Aidarex Pharmaceuticals LLC ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 33261-485_9caae802-6283-4387-95dd-82aa5542a22d 33261-485 HUMAN PRESCRIPTION DRUG cephalexin Cephalexin FOR SUSPENSION ORAL 20060111 ANDA ANDA065234 Aidarex Pharmaceuticals LLC CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 33261-486_102c0c6c-be48-40e6-8299-031e8f3dc843 33261-486 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Aidarex Pharmaceuticals LLC ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 33261-487_d623665e-8c16-4726-a5ea-69427c124f03 33261-487 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Aidarex Pharmaceuticals LLC FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 33261-488_9abd651c-3fc9-4426-9392-6e2a783d3d8e 33261-488 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Aidarex Pharmaceuticals LLC AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 33261-491_7a30fb41-2a84-4afb-a155-46dba2cfb76a 33261-491 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970423 ANDA ANDA074556 Aidarex Pharmaceuticals LLC ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 33261-495_f0ecf791-3c3e-4d4d-8ab8-57d2afc63f0a 33261-495 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 Aidarex Pharmaceuticals LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 33261-500_93729350-108f-4474-811d-9e4ca0294eac 33261-500 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Aidarex Pharmaceuticals LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 33261-517_e821edd9-cd2c-4f50-92a2-ab13a5823e86 33261-517 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Aidarex Pharmaceuticals LLC ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 33261-520_60ad2cb3-c0b0-4bc6-be97-bc62cb405d1e 33261-520 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20050428 ANDA ANDA088799 Aidarex Pharmaceuticals LLC HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 33261-532_fed33441-965f-40ad-af22-e32244a884cd 33261-532 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073553 Aidarex Pharmaceuticals LLC NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 33261-534_625f2552-b7bf-4ee3-a58e-9e22578f2280 33261-534 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 Aidarex Pharmaceuticals LLC MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 33261-535_0d247451-52f8-45ba-a1ec-91401605c8d0 33261-535 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Aidarex Pharmaceuticals LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 33261-536_b01ba900-3657-4093-875f-11c5140561a3 33261-536 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Aidarex Pharmaceuticals LLC CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 33261-537_381aa246-233f-490b-80cb-91fef3b7bf56 33261-537 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Aidarex Pharmaceuticals LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 33261-541_733c33c5-9968-4f49-9f73-2aab91932134 33261-541 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Aidarex Pharmaceuticals LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 33261-542_733c33c5-9968-4f49-9f73-2aab91932134 33261-542 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Aidarex Pharmaceuticals LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 33261-545_1615bea2-4bef-460c-9bde-65b19531f000 33261-545 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19940527 ANDA ANDA074217 Aidarex Pharmaceuticals LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 33261-546_733c33c5-9968-4f49-9f73-2aab91932134 33261-546 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Aidarex Pharmaceuticals LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 33261-547_397bf662-ca3a-44ce-a21f-745cf71e15de 33261-547 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Aidarex Pharmaceuticals LLC LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 33261-548_397bf662-ca3a-44ce-a21f-745cf71e15de 33261-548 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Aidarex Pharmaceuticals LLC LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 33261-549_397bf662-ca3a-44ce-a21f-745cf71e15de 33261-549 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Aidarex Pharmaceuticals LLC LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 33261-550_b6201f98-9bd5-4cde-87b6-750478ff74ae 33261-550 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine maleate TABLET ORAL 19980301 ANDA ANDA040268 Aidarex Pharmaceuticals LLC PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 33261-554_533f028c-bba8-491b-9860-bd45f27d352b 33261-554 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Aidarex Pharmaceuticals LLC ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 33261-562_316b2807-6d53-4d3d-9346-064bccd2fd60 33261-562 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 Aidarex Pharmaceuticals LLC FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 33261-564_3ad10c0b-4d0f-44dd-a9ca-9ed8289d52ef 33261-564 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 19720630 ANDA ANDA080198 Aidarex Pharmaceuticals LLC LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 33261-591_23d5e33c-26ef-43a2-a88f-5b601eeb126d 33261-591 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine Lidocaine and Prilocaine CREAM TOPICAL 20030925 ANDA ANDA076290 Aidarex Pharmaceuticals LLC LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 33261-594_93729350-108f-4474-811d-9e4ca0294eac 33261-594 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Aidarex Pharmaceuticals LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 33261-597_294053a9-959b-49d5-a4e7-f0e4e2061e4e 33261-597 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018877 Aidarex Pharmaceuticals LLC ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 33261-600_7f5fefc0-1979-45a2-966c-616ca2ccfa7f 33261-600 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20010622 NDA NDA050755 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 33261-602_1135c0be-16b1-4427-aaa6-bd81d53ed2fb 33261-602 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 Aidarex Pharmaceuticals LLC AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 33261-604_2323a0e0-63f8-4083-bda3-2f65f374fd40 33261-604 HUMAN PRESCRIPTION DRUG GENTAMICIN SULFATE gentamicin sulfate SOLUTION/ DROPS OPHTHALMIC 19980105 ANDA ANDA062452 Aidarex Pharmaceuticals LLC GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 33261-609_625f2552-b7bf-4ee3-a58e-9e22578f2280 33261-609 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 Aidarex Pharmaceuticals LLC MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 33261-618_c32a755e-ce62-4ae6-a581-e1f2f26e65ed 33261-618 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20060531 ANDA ANDA065266 Aidarex Pharmaceuticals LLC CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 33261-621_38af301a-ce6f-4d9e-b36a-a20cd38b8618 33261-621 HUMAN PRESCRIPTION DRUG Divalproex SodiumDelayed-Release Delayed-Release Divalproex Sodium TABLET, FILM COATED ORAL 20091130 ANDA ANDA090210 Aidarex Pharmaceuticals LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 33261-623_1db86484-b07f-4b68-85f0-547d7e723183 33261-623 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Aidarex Pharmaceuticals LLC CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 33261-625_cb55bd60-89dd-4231-a2da-2694ed2973fb 33261-625 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088238 Aidarex Pharmaceuticals LLC DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 33261-626_3b66c2f6-3d9f-4bc4-bad4-c6736f1d45e7 33261-626 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aidarex Pharmaceuticals LLC AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 33261-627_9e647b64-0405-4e32-97bd-0edb09854911 33261-627 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070612 ANDA ANDA077284 Aidarex Pharmaceuticals LLC BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 33261-628_8fa29043-847f-4835-b929-70ac0e139880 33261-628 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Aidarex Pharmaceuticals LLC CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 33261-631_c32a755e-ce62-4ae6-a581-e1f2f26e65ed 33261-631 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20060531 ANDA ANDA065266 Aidarex Pharmaceuticals LLC CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 33261-634_5e2ff1d2-363a-41a0-b6ac-8ced16c6fb7b 33261-634 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 Aidarex Pharmaceuticals LLC BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 33261-641_c587a83e-6bd2-4645-8044-0884fbb2bc4f 33261-641 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 Aidarex Pharmaceuticals LLC DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 33261-642_dc4501f9-c70f-46c1-811b-d72fdc4af22c 33261-642 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Aidarex Pharmaceuticals LLC PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 33261-643_dc4501f9-c70f-46c1-811b-d72fdc4af22c 33261-643 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Aidarex Pharmaceuticals LLC PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 33261-644_1e7747a9-6c6e-4026-8be6-5963db67ed61 33261-644 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Aidarex Pharmaceuticals LLC LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33261-645_1e7747a9-6c6e-4026-8be6-5963db67ed61 33261-645 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Aidarex Pharmaceuticals LLC LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33261-646_1e7747a9-6c6e-4026-8be6-5963db67ed61 33261-646 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Aidarex Pharmaceuticals LLC LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33261-647_d62710fe-d3d0-4714-b3bb-e1f6dd916946 33261-647 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 Aidarex Pharmaceuticals LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 33261-648_3ccfd582-29b5-4ea0-8f3b-2bd4fca4ace0 33261-648 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111101 ANDA ANDA090170 Aidarex Pharmaceuticals LLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 33261-651_d2826e15-72bb-4bba-9f87-d2661147caca 33261-651 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 19941001 OTC MONOGRAPH FINAL part341 Aidarex Pharmaceuticals LLC PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 CI 33261-658_8828c164-2572-4b0e-8228-d86a9ca630d0 33261-658 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20111027 ANDA ANDA075509 Aidarex Pharmaceuticals LLC DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 33261-665_8fa5d478-4b57-48f2-80ef-746f8f8953b6 33261-665 HUMAN OTC DRUG Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Aidarex Pharmaceuticals LLC ACETAMINOPHEN 650 mg/1 33261-667_81b5ab1e-b277-43ac-9a7b-d14d60457c12 33261-667 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 Aidarex Pharmaceuticals LLC ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 33261-672_b6c1e040-459d-4640-b493-c18c2d96faea 33261-672 HUMAN PRESCRIPTION DRUG LIDODERM lidocaine PATCH CUTANEOUS 19990320 NDA NDA020612 Aidarex Pharmaceuticals LLC LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 33261-674_39a3e584-a805-427d-8f53-44c2ad215b2f 33261-674 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20101015 ANDA ANDA091269 Aidarex Pharmaceuticals LLC LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 33261-676_2b8c4ae6-ba9f-43d3-93d1-e731b10a0a4d 33261-676 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 Aidarex Pharmaceuticals LLC CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 33261-677_e4ca368f-2ead-4dd5-bdfb-53644b99e8c9 33261-677 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130 ANDA ANDA078554 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-679_e4ca368f-2ead-4dd5-bdfb-53644b99e8c9 33261-679 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130 ANDA ANDA078554 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-680_9e647b64-0405-4e32-97bd-0edb09854911 33261-680 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081125 ANDA ANDA077284 Aidarex Pharmaceuticals LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 33261-683_c52564a5-732a-4f66-803b-4a3d55d53306 33261-683 HUMAN PRESCRIPTION DRUG fluvoxamine maleate Fluvoxamine maleate TABLET, COATED ORAL 20110809 NDA AUTHORIZED GENERIC NDA021519 Aidarex Pharmaceuticals LLC FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-684_c432adf9-17a7-4c67-8488-0c67c6185103 33261-684 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 Aidarex Pharmaceuticals LLC OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33261-685_f88e1600-0e18-433a-90ae-1dcc7817bb59 33261-685 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 Aidarex Pharmaceuticals LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 33261-686_d73d3c7c-5e0c-43b7-992c-105eb90c7103 33261-686 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Aidarex Pharmaceuticals LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-692_7f8fad0a-267b-4284-9de3-14ddd77d9ac0 33261-692 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Aidarex Pharmaceuticals LLC NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 33261-699_d73d3c7c-5e0c-43b7-992c-105eb90c7103 33261-699 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Aidarex Pharmaceuticals LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-707_a9c631b4-b783-4a4b-9b9e-f79bb60a7437 33261-707 HUMAN OTC DRUG Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 20020301 OTC MONOGRAPH FINAL part333B Aidarex Pharmaceuticals LLC BACITRACIN ZINC 500 [USP'U]/g 33261-714_81b5ab1e-b277-43ac-9a7b-d14d60457c12 33261-714 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 Aidarex Pharmaceuticals LLC ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 33261-717_1288f851-da84-40fb-9b2c-d50c826fe791 33261-717 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Aidarex Pharmaceuticals LLC DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 33261-718_3c3b0660-703a-49d4-90ae-8b6a71bc049b 33261-718 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride TABLET ORAL 20100604 ANDA ANDA040659 Aidarex Pharmaceuticals LLC MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 33261-724_56cf45ce-a692-486e-a961-3d53f18d418a 33261-724 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20130531 ANDA ANDA203399 Aidarex Pharmaceuticals LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 33261-726_2c889e7d-281d-49ad-be10-1d316637583d 33261-726 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 Aidarex Pharmaceuticals LLC AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 33261-728_76932243-b0df-474c-aa58-b41c89d051d7 33261-728 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060410 ANDA ANDA077912 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 33261-730_42c39262-6a30-42e7-a2a8-5b1b98a0c851 33261-730 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20090817 ANDA ANDA040833 Aidarex Pharmaceuticals LLC ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 33261-732_2c926159-2df1-424e-b19f-197833e3dd10 33261-732 HUMAN PRESCRIPTION DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL 20060214 ANDA ANDA040649 Aidarex Pharmaceuticals LLC DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 33261-737_716cfc62-96c0-46e2-aa7c-a8093b793195 33261-737 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC) 20080317 ANDA ANDA076128 Aidarex Pharmaceuticals LLC OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 33261-738_e299aa52-24b3-4b98-9ea8-791b5f4c5628 33261-738 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20020917 ANDA ANDA075907 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33261-739_dcbd7cb5-fde6-4c95-b453-0b5c1c8dd069 33261-739 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615 ANDA ANDA075319 Aidarex Pharmaceuticals LLC KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 33261-740_625f2552-b7bf-4ee3-a58e-9e22578f2280 33261-740 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961203 ANDA ANDA040159 Aidarex Pharmaceuticals LLC MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 33261-741_25385136-ce02-4fd2-a88e-e27da4b0fc0e 33261-741 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Aidarex Pharmaceuticals LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 33261-745_1156d9cb-4ad2-49c0-b7ee-4b947c5dcc84 33261-745 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Aidarex Pharmaceuticals LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 33261-747_c864bb57-bef4-4d7d-91c7-7e70ce696656 33261-747 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Aidarex Pharmaceuticals LLC ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 33261-748_9c33b6af-82fa-46f5-805d-d2508400e10e 33261-748 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20060714 OTC MONOGRAPH FINAL part336 Aidarex Pharmaceuticals LLC MECLIZINE HYDROCHLORIDE 12.5 mg/1 33261-749_99e011cc-0e61-4ecd-87c7-04d397ee15e6 33261-749 HUMAN OTC DRUG SENEXON-S DOCUSATE SODIUM -SENNOSIDES TABLET, COATED ORAL 20110316 OTC MONOGRAPH NOT FINAL part334 Aidarex Pharmaceuticals LLC DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 33261-754_384c955d-a727-43b5-be9e-3e6f501cf2d3 33261-754 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 Aidarex Pharmaceuticals LLC MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 33261-756_5a387e4b-9fde-43fa-bd07-ac2a369147ba 33261-756 HUMAN PRESCRIPTION DRUG Sulfasalazine sulfasalazine TABLET ORAL 20020111 ANDA ANDA040349 Aidarex Pharmaceuticals LLC SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 33261-758_7e7541d1-017e-4bcc-8ae6-3735c2b5d307 33261-758 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20070711 ANDA ANDA077621 Aidarex Pharmaceuticals LLC AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 33261-761_c864bb57-bef4-4d7d-91c7-7e70ce696656 33261-761 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Aidarex Pharmaceuticals LLC ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 33261-764_b82a7117-a881-4efb-a22a-69842616fbb5 33261-764 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Aidarex Pharmaceuticals LLC SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 33261-766_12a87643-479a-4a6c-b307-646c58aa89f6 33261-766 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Aidarex Pharmaceuticals LLC AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 33261-770_2af6c8f6-8041-421c-943a-7ee745600a9a 33261-770 HUMAN OTC DRUG good sense pain reliefchildrens childrens Acetaminophen SUSPENSION ORAL 19930225 OTC MONOGRAPH NOT FINAL part343 Aidarex Pharmaceuticals LLC ACETAMINOPHEN 160 mg/5mL 33261-773_1a42734f-af17-498b-bc15-a3f7e0004fae 33261-773 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19870218 ANDA ANDA071293 Aidarex Pharmaceuticals LLC AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 33261-780_3eb42c9e-ade5-41e9-8fb2-32551a571d28 33261-780 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Aidarex Pharmaceuticals LLC PREDNISONE 5 mg/1 33261-786_fe04d17d-f5c0-4dc3-b61c-8b8a0c88f0d4 33261-786 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole GEL VAGINAL 20070331 NDA AUTHORIZED GENERIC NDA020208 Aidarex Pharmaceuticals LLC METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 33261-788_096a2ff6-e875-4d62-bad8-3afa55c8fede 33261-788 HUMAN OTC DRUG ProCoMycin Bacitracin, Neomycin, Polymyxin B and Lidocain Hydrochloride CREAM TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part348 Aidarex Pharmaceuticals LLC BACITRACIN; LIDOCAINE HYDROCHLORIDE; NEOMYCIN; POLYMYXIN B 500; .04; .0035; 10000 [iU]/g; g/g; g/g; [iU]/g 33261-789_4649abda-b4ec-41f8-b1bc-d1ae0aade616 33261-789 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20111205 ANDA ANDA077839 Aidarex Pharmaceuticals LLC ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 33261-793_5de98130-babf-405b-994a-d117eef9ef57 33261-793 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Aidarex Pharmaceuticals LLC LEVOFLOXACIN 500 mg/1 33261-796_df8cbb50-2a88-45c4-8e36-8fdc9813aa17 33261-796 HUMAN OTC DRUG Promolaxin Docusate sodium TABLET ORAL 20110415 OTC MONOGRAPH NOT FINAL part334 Aidarex Pharmaceuticals LLC DOCUSATE SODIUM 100 mg/1 33261-797_7b3d0f95-398a-40f5-8c02-77031cf6de12 33261-797 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 Aidarex Pharmaceuticals LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 33261-798_86561340-1ee9-44d0-adab-55bc9bbfe66a 33261-798 HUMAN OTC DRUG Acetadryl Acetaminophen and diphenhyramine TABLET, FILM COATED ORAL 20110721 OTC MONOGRAPH NOT FINAL part343 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 33261-804_7f8fad0a-267b-4284-9de3-14ddd77d9ac0 33261-804 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Aidarex Pharmaceuticals LLC NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 33261-810_294053a9-959b-49d5-a4e7-f0e4e2061e4e 33261-810 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018832 Aidarex Pharmaceuticals LLC ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 33261-811_764aad3f-97f7-4762-84b8-7df245c261b6 33261-811 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20090609 ANDA ANDA090035 Aidarex Pharmaceuticals LLC FOLIC ACID 1 mg/1 33261-813_fea6f761-235f-4d3d-99c6-6389070ec7d9 33261-813 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Aidarex Pharmaceuticals LLC GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 33261-814_8d4746af-7b95-4b44-9010-cc77908c2987 33261-814 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-816_8d4746af-7b95-4b44-9010-cc77908c2987 33261-816 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-817_656e9454-b292-4d3a-95d5-157e26365f3a 33261-817 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA090425 Aidarex Pharmaceuticals LLC DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 33261-818_1641b016-62df-4c69-bfa4-e7b378e078bc 33261-818 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Aidarex Pharmaceuticals LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 33261-819_1641b016-62df-4c69-bfa4-e7b378e078bc 33261-819 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Aidarex Pharmaceuticals LLC LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 33261-820_353a5ff7-34d8-4cb4-aaab-1cba7ed4b4de 33261-820 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Aidarex Pharmaceuticals LLC ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 33261-823_c89c67cd-6934-439f-b064-cab508c1cdda 33261-823 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 Aidarex Pharmaceuticals LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 33261-824_b544b0fa-d59a-481e-bb83-a5e49e0ad5eb 33261-824 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 Aidarex Pharmaceuticals LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 33261-825_c89c67cd-6934-439f-b064-cab508c1cdda 33261-825 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 Aidarex Pharmaceuticals LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 33261-826_0d247451-52f8-45ba-a1ec-91401605c8d0 33261-826 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Aidarex Pharmaceuticals LLC AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 33261-828_76932243-b0df-474c-aa58-b41c89d051d7 33261-828 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20061004 ANDA ANDA077912 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 33261-829_4da3b18f-eb1c-49ac-8387-07e16931208d 33261-829 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 Aidarex Pharmaceuticals LLC DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 33261-830_3d03c9eb-c4a2-4d2c-9be3-3c18753096ad 33261-830 HUMAN PRESCRIPTION DRUG GlipizideER ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031101 ANDA ANDA076467 Aidarex Pharmaceuticals LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 33261-831_a3716d08-1cdd-4f4b-b463-d0bbca9e1e8a 33261-831 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20130613 ANDA ANDA091220 Aidarex Pharmaceuticals LLC GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 33261-833_7cc09057-0a72-4ba6-9541-b8b5501d885f 33261-833 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET ORAL 20121025 ANDA ANDA090061 Aidarex Pharmaceuticals LLC FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 33261-835_3d03c9eb-c4a2-4d2c-9be3-3c18753096ad 33261-835 HUMAN PRESCRIPTION DRUG GlipizideER ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031107 ANDA ANDA076467 Aidarex Pharmaceuticals LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 33261-838_77aef3a9-ef00-41af-b739-00592f4e3bdc 33261-838 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100406 ANDA ANDA077157 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33261-839_22df39d3-1e71-4b07-8d0e-9ed581d66142 33261-839 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100427 ANDA ANDA078938 Aidarex Pharmaceuticals LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 33261-840_5a9ac93d-ff59-4778-b735-9320d48d1c31 33261-840 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20071003 ANDA ANDA077410 Aidarex Pharmaceuticals LLC NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 33261-841_c432adf9-17a7-4c67-8488-0c67c6185103 33261-841 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 Aidarex Pharmaceuticals LLC OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33261-842_c432adf9-17a7-4c67-8488-0c67c6185103 33261-842 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 Aidarex Pharmaceuticals LLC OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33261-843_b3e49f2c-8d6c-4690-863c-9417fb41ed05 33261-843 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20051222 ANDA ANDA077636 Aidarex Pharmaceuticals LLC ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33261-844_02884744-7135-46f2-b795-ef42215204ec 33261-844 HUMAN PRESCRIPTION DRUG NifedicalXL XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20010209 ANDA ANDA075289 Aidarex Pharmaceuticals LLC NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 33261-846_2e92a75c-ab99-49b1-8033-efbbcace2d68 33261-846 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Aidarex Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 33261-847_404f5030-f1b4-4756-bd33-0c2a5e7afd8a 33261-847 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Aidarex Pharmaceuticals LLC DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 33261-848_381aa246-233f-490b-80cb-91fef3b7bf56 33261-848 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Aidarex Pharmaceuticals LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 33261-849_dcae48af-ca48-4448-92b6-4ad661582bf4 33261-849 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Aidarex Pharmaceuticals LLC RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 33261-852_44f34237-4966-4f7f-8b00-873195c81adb 33261-852 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 Aidarex Pharmaceuticals LLC LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 33261-858_b0679889-19c0-4615-968d-a108d2482aeb 33261-858 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA086183 Aidarex Pharmaceuticals LLC HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 33261-859_5a14624a-9938-4d95-b044-68766cf97e78 33261-859 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20110829 ANDA ANDA078722 Aidarex Pharmaceuticals LLC CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 33261-860_0b789977-c3b1-495d-9dcb-1d7f4295eb08 33261-860 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071994 Aidarex Pharmaceuticals LLC PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 33261-861_0b789977-c3b1-495d-9dcb-1d7f4295eb08 33261-861 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071995 Aidarex Pharmaceuticals LLC PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 33261-865_d3cfec5b-8dfb-4138-8ee0-09bf49a5c38e 33261-865 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20120717 ANDA ANDA040712 Aidarex Pharmaceuticals LLC PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 33261-867_74ec5981-fcf7-4164-a03f-2d6656a5f46f 33261-867 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Aidarex Pharmaceuticals LLC PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 33261-868_74ec5981-fcf7-4164-a03f-2d6656a5f46f 33261-868 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Aidarex Pharmaceuticals LLC PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 33261-869_b82a7117-a881-4efb-a22a-69842616fbb5 33261-869 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Aidarex Pharmaceuticals LLC SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 33261-870_ce7c1472-b399-493e-a419-e71701b04acc 33261-870 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20010412 ANDA ANDA075498 Aidarex Pharmaceuticals LLC TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 33261-871_b467b2f6-9ecd-45be-a714-664764233d01 33261-871 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Aidarex Pharmaceuticals LLC MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 33261-873_363f91f4-00cf-461e-b14b-85923fed3331 33261-873 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20010228 NDA NDA021077 Aidarex Pharmaceuticals LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 100; 50 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 33261-874_363f91f4-00cf-461e-b14b-85923fed3331 33261-874 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20010205 NDA NDA021077 Aidarex Pharmaceuticals LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 250; 50 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 33261-876_5de98130-babf-405b-994a-d117eef9ef57 33261-876 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Aidarex Pharmaceuticals LLC LEVOFLOXACIN 750 mg/1 33261-879_335dec43-2c8b-4432-81e1-f9284a7a834f 33261-879 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065405 Aidarex Pharmaceuticals LLC AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 33261-880_17c072f1-844b-40b2-b764-bfa7347ffd0b 33261-880 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120314 NDA NDA022370 Aidarex Pharmaceuticals LLC TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 33261-881_a7273cd2-4d7a-4913-834c-dbdc0b9a5283 33261-881 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen HYDROCODONE BITARTRATE, ACETAMINOPHEN TABLET ORAL 20120517 ANDA ANDA040846 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 33261-883_3b58ae4d-381a-4d4d-85db-afb884621916 33261-883 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine CAPSULE ORAL 20050720 ANDA ANDA076990 Aidarex Pharmaceuticals LLC FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-884_c8bbb594-e795-431e-aeb8-800da6a7db1f 33261-884 HUMAN OTC DRUG MEDROX MENTHOL, CAPSAICIN PATCH TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part348 Aidarex Pharmaceuticals LLC CAPSAICIN; MENTHOL .0375; 5 g/100g; g/100g 33261-888_fdb92d03-2a1a-4b64-ad4f-391f8f977bb8 33261-888 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20051110 ANDA ANDA065277 Aidarex Pharmaceuticals LLC DOXYCYCLINE HYCLATE 20 mg/1 33261-891_5de98130-babf-405b-994a-d117eef9ef57 33261-891 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Aidarex Pharmaceuticals LLC LEVOFLOXACIN 250 mg/1 33261-892_0bbcdb96-76b4-4d74-a385-9ead00baa8ef 33261-892 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Aidarex Pharmaceuticals LLC GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 33261-895_b82a7117-a881-4efb-a22a-69842616fbb5 33261-895 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Aidarex Pharmaceuticals LLC SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 33261-896_a7bdbe31-8699-40f4-b6a1-d30b99cb97ec 33261-896 HUMAN PRESCRIPTION DRUG Nystatin nystatin TABLET, FILM COATED ORAL 19881222 ANDA ANDA062838 Aidarex Pharmaceuticals LLC NYSTATIN 500000 [USP'U]/1 Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 33261-898_f6787aa2-956b-47da-91fd-cdc7d8695df9 33261-898 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Aidarex Pharmaceuticals LLC METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 33261-899_e1ddd097-1fc0-467c-b770-4e815160bc04 33261-899 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19821013 ANDA ANDA062031 Aidarex Pharmaceuticals LLC DOXYCYCLINE HYCLATE 50 mg/1 33261-900_ca6dd35c-a11d-498f-9086-9fd681470743 33261-900 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20110818 ANDA ANDA091211 Aidarex Pharmaceuticals LLC ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 33261-903_1ecbc0cc-35c9-46ff-b07d-b7d1ae7a9335 33261-903 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Aidarex Pharmaceuticals LLC RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 33261-904_b125e99c-f968-4ece-9c23-64aa5b1e4986 33261-904 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA077732 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33261-905_bb942e65-f5fb-4d99-801e-79c6b680e217 33261-905 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070501 ANDA ANDA065259 Aidarex Pharmaceuticals LLC CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 33261-907_4da79ad0-8d67-4080-82db-8cab5f049213 33261-907 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Extended-Release Hyoscyamine Sulfate Extended-Release TABLET ORAL 20100103 UNAPPROVED DRUG OTHER Aidarex Pharmaceuticals LLC HYOSCYAMINE SULFATE .375 mg/1 33261-908_c378686f-8bf4-4fff-9b88-d5a18ce37135 33261-908 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Aidarex Pharmaceuticals LLC LORATADINE 5 mg/5mL 33261-918_67b56f89-ea09-427c-95ff-f358b6eb256e 33261-918 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 Aidarex Pharmaceuticals LLC BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33261-922_208b6d91-6e3f-48ac-a86d-767e735dadb8 33261-922 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, and Caffeine butalbital, aspirin, and caffeine CAPSULE ORAL 19760504 NDA AUTHORIZED GENERIC NDA017534 Aidarex Pharmaceuticals LLC ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 33261-933_ba4280ea-864c-4f79-97f9-7438fa0a6105 33261-933 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20090107 ANDA ANDA040766 Aidarex Pharmaceuticals LLC HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 33261-935_0a6cb56c-0b44-45d8-8538-ca16e678ab9b 33261-935 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Aidarex Pharmaceuticals LLC LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 33261-942_ca7a45f2-b48d-45b1-ab29-53da0dd9cf71 33261-942 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Aidarex Pharmaceuticals LLC ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 33261-944_3b66c2f6-3d9f-4bc4-bad4-c6736f1d45e7 33261-944 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aidarex Pharmaceuticals LLC AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 33261-946_d62710fe-d3d0-4714-b3bb-e1f6dd916946 33261-946 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 Aidarex Pharmaceuticals LLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 33261-947_803c7ca1-ccca-4d6f-9365-d0c26530700a 33261-947 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET, FILM COATED ORAL 20130205 ANDA ANDA090362 Aidarex Pharmaceuticals LLC LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 33261-950_77aef3a9-ef00-41af-b739-00592f4e3bdc 33261-950 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100406 ANDA ANDA077157 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33261-951_a87947cb-f21c-4345-a83d-03518b670e9e 33261-951 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951226 ANDA ANDA074185 Aidarex Pharmaceuticals LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 33261-952_6316b11a-923a-4944-b814-31bd8a934db9 33261-952 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20090921 ANDA ANDA071251 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33261-953_74ec5981-fcf7-4164-a03f-2d6656a5f46f 33261-953 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Aidarex Pharmaceuticals LLC PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 33261-954_4cae7a30-ddc2-4e4f-b4c5-17d8eb69ee78 33261-954 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Aidarex Pharmaceuticals LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-955_fff7cc6b-ece8-4ff9-942d-118822b5eae5 33261-955 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20120911 ANDA ANDA090939 Aidarex Pharmaceuticals LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33261-956_210af85b-9e0f-4bd9-94f9-77ffe42b013f 33261-956 HUMAN PRESCRIPTION DRUG Econazole Nitrate Econazole Nitrate CREAM TOPICAL 20021126 ANDA ANDA076005 Aidarex Pharmaceuticals LLC ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 33261-959_9c180770-0e8d-4dde-b049-8b3a615cf105 33261-959 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Aidarex Pharmaceuticals LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 33261-963_265be229-6d0b-4ceb-a94a-7f84ca2c3141 33261-963 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19740930 ANDA ANDA084285 Aidarex Pharmaceuticals LLC DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 33261-964_2e490478-f34d-4b76-bdac-b9678042bb3a 33261-964 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 Aidarex Pharmaceuticals LLC LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 33261-966_7cab8cc1-8128-45fc-87a2-639f07d4d60f 33261-966 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20100201 ANDA ANDA076509 Aidarex Pharmaceuticals LLC FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 33261-967_1ecbc0cc-35c9-46ff-b07d-b7d1ae7a9335 33261-967 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Aidarex Pharmaceuticals LLC RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 33261-969_733ee823-ddd2-45b5-9d27-44105e5bf34c 33261-969 HUMAN PRESCRIPTION DRUG montelukast sodium montelukast sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA090926 Aidarex Pharmaceuticals LLC MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 33261-970_2fce4fed-89a2-4fa9-a1b0-a8dc087ae983 33261-970 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20010622 NDA NDA050755 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 33261-972_4cea1f5c-07d8-4ae8-8d22-5578b510c62d 33261-972 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Aidarex Pharmaceuticals LLC ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 33261-974_b01ba900-3657-4093-875f-11c5140561a3 33261-974 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Aidarex Pharmaceuticals LLC CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 33261-975_725bef53-880f-4402-8b86-b732911c80bf 33261-975 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aidarex Pharmaceuticals LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 33261-982_bbb38451-c948-492b-9998-cebf028a6052 33261-982 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Aidarex Pharmaceuticals LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 33261-983_ae72cf6a-bf5f-424c-8d8c-1aaffbb89826 33261-983 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Aidarex Pharmaceuticals LLC BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 33261-986_725bef53-880f-4402-8b86-b732911c80bf 33261-986 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aidarex Pharmaceuticals LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 33261-987_0ea55b0e-a44e-4b1f-be1b-314d92b7ccc2 33261-987 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA090540 Aidarex Pharmaceuticals LLC CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 33261-988_0793439e-5691-4317-b98d-66079435969e 33261-988 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 33261-989_603f002e-7b62-4777-be74-66e0ffffb894 33261-989 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 33261-992_c85bc0c3-d37b-454b-ba21-199a6d33e9ba 33261-992 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 19990610 ANDA ANDA075191 Aidarex Pharmaceuticals LLC PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 33261-993_78a8700b-3eb9-4c00-b274-3bddc6208a34 33261-993 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Aidarex Pharmaceuticals LLC ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 33261-994_49778501-d326-4ead-9fa5-b9d30228ff2d 33261-994 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111122 ANDA ANDA079057 Aidarex Pharmaceuticals LLC ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 33261-996_1641b016-62df-4c69-bfa4-e7b378e078bc 33261-996 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Aidarex Pharmaceuticals LLC LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 33332-014_e1febaef-843e-48b9-a65c-d00bbdb1c35e 33332-014 VACCINE AFLURIA INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20110715 BLA BLA125254 CSL Limited INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL Inactivated Influenza A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient] 33332-114_e1febaef-843e-48b9-a65c-d00bbdb1c35e 33332-114 VACCINE AFLURIA INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20110715 BLA BLA125254 CSL Limited INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL Inactivated Influenza A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient] 33335-001_805e1bb8-1308-48c8-b0b4-ff5c99bb8b33 33335-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19410101 UNAPPROVED MEDICAL GAS WELSCO, INC. OXYGEN 995 mL/L 33335-002_2d901a90-5bf7-4666-9e6c-88951e556d1a 33335-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20010101 UNAPPROVED MEDICAL GAS WELSCO, INC. NITROGEN 990 mL/L 33342-015_75863c47-e236-4343-853f-30262fea18e6 33342-015 HUMAN PRESCRIPTION DRUG Amlodipine Amlodipine TABLET ORAL 20120413 ANDA ANDA201380 Macleods Pharmaceuticals Limited AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 33342-016_75863c47-e236-4343-853f-30262fea18e6 33342-016 HUMAN PRESCRIPTION DRUG Amlodipine Amlodipine TABLET ORAL 20120413 ANDA ANDA201380 Macleods Pharmaceuticals Limited AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 33342-019_fb3ec44f-8fa9-4423-afa6-59d5373a5a1f 33342-019 HUMAN PRESCRIPTION DRUG Pantoprazole sodium Pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20111203 ANDA ANDA200821 Macleods Pharmaceuticals Limited PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 33342-020_fb3ec44f-8fa9-4423-afa6-59d5373a5a1f 33342-020 HUMAN PRESCRIPTION DRUG Pantoprazole sodium Pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20111203 ANDA ANDA200821 Macleods Pharmaceuticals Limited PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 33342-021_66aba949-07c2-49ec-b78d-29e8cd43bfa5 33342-021 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 Macleods Pharmaceuticals Limited LEVOFLOXACIN 250 mg/1 33342-022_66aba949-07c2-49ec-b78d-29e8cd43bfa5 33342-022 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 Macleods Pharmaceuticals Limited LEVOFLOXACIN 500 mg/1 33342-023_66aba949-07c2-49ec-b78d-29e8cd43bfa5 33342-023 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 Macleods Pharmaceuticals Limited LEVOFLOXACIN 750 mg/1 33342-024_aef09cf5-9350-438c-9a76-a536eef9f2f5 33342-024 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20111217 ANDA ANDA201022 Macleods Pharmaceuticals Limited FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 33342-025_aef09cf5-9350-438c-9a76-a536eef9f2f5 33342-025 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20111217 ANDA ANDA201022 Macleods Pharmaceuticals Limited FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 33342-026_aef09cf5-9350-438c-9a76-a536eef9f2f5 33342-026 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20111217 ANDA ANDA201022 Macleods Pharmaceuticals Limited FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 33342-027_8c66c0db-5a26-4615-b34e-88a3f3d96d27 33342-027 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20120817 ANDA ANDA201146 Macleods Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 33342-028_8c66c0db-5a26-4615-b34e-88a3f3d96d27 33342-028 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20120817 ANDA ANDA201146 Macleods Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 33342-029_e1e203cd-fd4c-4046-810b-5d7aea47525e 33342-029 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20121214 ANDA ANDA201146 Macleods Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 33342-030_e1e203cd-fd4c-4046-810b-5d7aea47525e 33342-030 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20121214 ANDA ANDA201146 Macleods Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 33342-031_21dfed34-f9ac-4f0e-bde2-72056d74babf 33342-031 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20120921 ANDA ANDA202164 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 33342-032_21dfed34-f9ac-4f0e-bde2-72056d74babf 33342-032 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20120921 ANDA ANDA202164 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 33342-033_21dfed34-f9ac-4f0e-bde2-72056d74babf 33342-033 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20120921 ANDA ANDA202164 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 33342-034_21dfed34-f9ac-4f0e-bde2-72056d74babf 33342-034 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20120921 ANDA ANDA202164 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 33342-035_21dfed34-f9ac-4f0e-bde2-72056d74babf 33342-035 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20120921 ANDA ANDA202164 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 33342-036_63fc7cb0-8de1-48fa-ad8d-bb08dfc501f4 33342-036 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA202210 Macleods Pharmaceuticals Limited ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33342-037_63fc7cb0-8de1-48fa-ad8d-bb08dfc501f4 33342-037 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA202210 Macleods Pharmaceuticals Limited ESCITALOPRAM OXALATE 10 mg/21 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33342-038_63fc7cb0-8de1-48fa-ad8d-bb08dfc501f4 33342-038 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA202210 Macleods Pharmaceuticals Limited ESCITALOPRAM OXALATE 20 mg/21 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33342-044_0a791c96-3b04-4344-990d-013f2cedf5d9 33342-044 HUMAN PRESCRIPTION DRUG Losartan potassium Losartan potassium TABLET, FILM COATED ORAL 20120510 ANDA ANDA202230 Macleods Pharmaceuticals Limited LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 33342-045_0a791c96-3b04-4344-990d-013f2cedf5d9 33342-045 HUMAN PRESCRIPTION DRUG Losartan potassium Losartan potassium TABLET, FILM COATED ORAL 20120601 ANDA ANDA202230 Macleods Pharmaceuticals Limited LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 33342-046_0a791c96-3b04-4344-990d-013f2cedf5d9 33342-046 HUMAN PRESCRIPTION DRUG Losartan potassium Losartan potassium TABLET, FILM COATED ORAL 20120601 ANDA ANDA202230 Macleods Pharmaceuticals Limited LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 33342-047_83cb7cab-f755-4570-9a9d-ad4d131a6ee8 33342-047 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA202254 Macleods Pharmaceuticals Limited IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 33342-048_83cb7cab-f755-4570-9a9d-ad4d131a6ee8 33342-048 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA202254 Macleods Pharmaceuticals Limited IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 33342-049_83cb7cab-f755-4570-9a9d-ad4d131a6ee8 33342-049 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA202254 Macleods Pharmaceuticals Limited IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 33342-050_5db59c6c-6123-497f-80ad-0c9fe63cb9d3 33342-050 HUMAN PRESCRIPTION DRUG Losartan potassium and Hydrochlorothiazide Losartan potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20120503 ANDA ANDA202289 Macleods Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33342-051_5db59c6c-6123-497f-80ad-0c9fe63cb9d3 33342-051 HUMAN PRESCRIPTION DRUG Losartan potassium and Hydrochlorothiazide Losartan potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20120503 ANDA ANDA202289 Macleods Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33342-052_5db59c6c-6123-497f-80ad-0c9fe63cb9d3 33342-052 HUMAN PRESCRIPTION DRUG Losartan potassium and Hydrochlorothiazide Losartan potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20120503 ANDA ANDA202289 Macleods Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33342-054_0777902c-7781-4a81-b7d1-9bc05669baad 33342-054 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130214 ANDA ANDA202467 Macleods Pharmaceuticals Limited PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 33342-055_0777902c-7781-4a81-b7d1-9bc05669baad 33342-055 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130214 ANDA ANDA202467 Macleods Pharmaceuticals Limited PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 33342-056_0777902c-7781-4a81-b7d1-9bc05669baad 33342-056 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130214 ANDA ANDA202467 Macleods Pharmaceuticals Limited PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 33342-057_aabf530c-a3ec-4b18-86d3-107988736f97 33342-057 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20120927 ANDA ANDA202414 Macleods Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33342-058_aabf530c-a3ec-4b18-86d3-107988736f97 33342-058 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20120927 ANDA ANDA202414 Macleods Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33342-060_e3ac1793-54b5-428f-ac4c-6418b1afd7bb 33342-060 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET ORAL 20121016 ANDA ANDA202928 Macleods Pharmaceuticals Limited CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 33342-061_ecddf11f-5784-4576-a7e6-1b3560c4d2ea 33342-061 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20140123 ANDA ANDA202631 Macleods Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 33342-067_8e095987-bdea-42f2-9550-c7155cf07d30 33342-067 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140822 ANDA ANDA202862 Macleods Pharmaceuticals Limited OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 33342-068_8e095987-bdea-42f2-9550-c7155cf07d30 33342-068 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140822 ANDA ANDA202862 Macleods Pharmaceuticals Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 33342-069_8e095987-bdea-42f2-9550-c7155cf07d30 33342-069 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140822 ANDA ANDA202862 Macleods Pharmaceuticals Limited OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 33342-070_8e095987-bdea-42f2-9550-c7155cf07d30 33342-070 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140822 ANDA ANDA202862 Macleods Pharmaceuticals Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 33342-071_8e095987-bdea-42f2-9550-c7155cf07d30 33342-071 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140822 ANDA ANDA202862 Macleods Pharmaceuticals Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 33342-072_8e095987-bdea-42f2-9550-c7155cf07d30 33342-072 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140822 ANDA ANDA202862 Macleods Pharmaceuticals Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 33342-074_aa31f3aa-d565-4f9e-8ba1-759d86d910f1 33342-074 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 Macleods Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33342-075_aa31f3aa-d565-4f9e-8ba1-759d86d910f1 33342-075 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 Macleods Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33342-076_aa31f3aa-d565-4f9e-8ba1-759d86d910f1 33342-076 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET ORAL 20130419 ANDA ANDA203145 Macleods Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33342-077_aa31f3aa-d565-4f9e-8ba1-759d86d910f1 33342-077 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 Macleods Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33342-078_aa31f3aa-d565-4f9e-8ba1-759d86d910f1 33342-078 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 Macleods Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 33342-087_27bc2cfc-fefb-4b50-a0dc-6268c69b4902 33342-087 HUMAN PRESCRIPTION DRUG Rizatriptan Rizatriptan TABLET, FILM COATED ORAL 20140311 ANDA ANDA203147 Macleods Pharmaceuticals Limited RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 33342-088_27bc2cfc-fefb-4b50-a0dc-6268c69b4902 33342-088 HUMAN PRESCRIPTION DRUG Rizatriptan Rizatriptan TABLET, FILM COATED ORAL 20140311 ANDA ANDA203147 Macleods Pharmaceuticals Limited RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 33342-089_4364f6ef-a8da-4805-be0d-aabbe8ca2d21 33342-089 HUMAN PRESCRIPTION DRUG RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE ORAL 20140902 ANDA ANDA203148 Macleods Pharmaceuticals Limited RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 33342-090_4364f6ef-a8da-4805-be0d-aabbe8ca2d21 33342-090 HUMAN PRESCRIPTION DRUG RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE ORAL 20140902 ANDA ANDA203148 Macleods Pharmaceuticals Limited RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 33342-091_4364f6ef-a8da-4805-be0d-aabbe8ca2d21 33342-091 HUMAN PRESCRIPTION DRUG RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE ORAL 20140902 ANDA ANDA203148 Macleods Pharmaceuticals Limited RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 33342-092_4364f6ef-a8da-4805-be0d-aabbe8ca2d21 33342-092 HUMAN PRESCRIPTION DRUG RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE ORAL 20140902 ANDA ANDA203148 Macleods Pharmaceuticals Limited RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 33342-093_57ed2505-28f1-4292-b3c3-a49bf0f7c683 33342-093 HUMAN PRESCRIPTION DRUG rizatriptan benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20140923 ANDA ANDA203146 Macleods Pharmaceuticals Limited RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 33342-094_57ed2505-28f1-4292-b3c3-a49bf0f7c683 33342-094 HUMAN PRESCRIPTION DRUG rizatriptan benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20140923 ANDA ANDA203146 Macleods Pharmaceuticals Limited RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 33342-102_d81f4de5-d287-45c0-b93c-0473a7b292ac 33342-102 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET ORAL 20120228 ANDA ANDA203366 Macleods Pharmaceuticals Limited MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 33342-121_05c046e3-d19d-4d3d-b745-bd577aae1e35 33342-121 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20140103 ANDA ANDA203814 Macleods Pharmaceuticals Limited SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 33344-001_85d1a81c-3921-4a54-91cb-85cc9739d173 33344-001 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19711101 UNAPPROVED MEDICAL GAS Welding & Therapy Service Inc. NITROGEN 99 L/100L 33344-002_b5af3d42-2c1d-44da-9fff-1faeb10a286d 33344-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen LIQUID RESPIRATORY (INHALATION) 19721101 UNAPPROVED MEDICAL GAS Welding & Therapy Service Inc. NITROGEN 99 L/100L 33344-003_a7819865-1852-46db-bbdb-75346d5339ec 33344-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19711101 UNAPPROVED MEDICAL GAS Welding & Therapy Service, Inc NITROUS OXIDE 99 L/100L 33344-004_7c8f7ec7-c0c5-4be7-a0ed-86ec81bedc53 33344-004 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide LIQUID RESPIRATORY (INHALATION) 19711101 UNAPPROVED MEDICAL GAS Welding & Therapy Service Inc. NITROUS OXIDE 99 L/100L 33344-005_c8fb0e08-185b-4446-92ed-364009e0fee8 33344-005 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19711101 UNAPPROVED MEDICAL GAS Welding & Therapy Service Inc. OXYGEN 99 L/100L 33344-006_22eb552f-7e4e-400e-859c-41b47361b1b9 33344-006 HUMAN PRESCRIPTION DRUG Oxygen Oxygen LIQUID RESPIRATORY (INHALATION) 19711101 UNAPPROVED MEDICAL GAS Welding & Therapy Service Inc. OXYGEN 99 L/100L 33358-001_4e83e52d-5b25-42b2-8aa7-9d38a2f9901e 33358-001 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20080529 ANDA ANDA040779 RxChange Co. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 33358-002_2b4756b1-9c97-44b9-b7df-19b88698786a 33358-002 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 20141105 ANDA ANDA089828 RxChange Co. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 33358-040_f5d68f39-a5e9-48e4-bab6-48b2d928d38f 33358-040 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20141113 ANDA ANDA065404 RxChange Co. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 33358-059_b8de7232-130a-4cd4-adb7-eb6062e634da 33358-059 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20141106 ANDA ANDA200243 RxChange Co. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 33358-064_c1f14976-f6a4-4389-bf36-4f053df760a3 33358-064 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20100701 ANDA ANDA040823 RxChange Co. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 33358-097_03ed81af-b588-41d3-bf01-1667e3d0a0f2 33358-097 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20141106 ANDA ANDA078218 RxChange Co. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 33358-153_7f8497ac-e984-403f-b5b5-27c5598826ec 33358-153 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20141026 ANDA ANDA078428 RxChange Co. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33358-154_1b9a1aa4-17bf-4f42-9d84-b9872e9b5c10 33358-154 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20141109 ANDA ANDA202764 RxChange Co. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 33358-187_13171729-20a2-4569-928f-dd38b8eb89dc 33358-187 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20141109 ANDA ANDA090796 RxChange Co. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33358-188_6c185dc7-5920-4293-b8b4-e090787debae 33358-188 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 RxChange Co. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33358-211_198f78ce-8573-417c-9a08-1362f731f6f3 33358-211 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20141118 ANDA ANDA077321 RxChange Co. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 33358-212_a4750725-8605-4dd3-a3cf-6eba9d58ae53 33358-212 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 RxChange Co. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 33358-213_3fcdae65-a7fb-4d99-9499-140fdb113a7b 33358-213 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20141112 ANDA ANDA075994 RxChange Co. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 33358-221_600dca46-0151-4959-9891-9a0e54d08a15 33358-221 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20141112 ANDA ANDA076045 RxChange Co. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 33358-251_5663a37f-b62f-4a8b-832a-33f95a4afbdc 33358-251 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20141113 ANDA ANDA078671 RxChange Co. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33358-252_5663a37f-b62f-4a8b-832a-33f95a4afbdc 33358-252 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20141113 ANDA ANDA078671 RxChange Co. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33358-259_e68706af-547f-4a60-8dc7-25e8f09e36dd 33358-259 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20141111 ANDA ANDA078432 RxChange Co. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33358-273_fb542691-0345-4b08-b534-6630f9bbe637 33358-273 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 RxChange Co. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 33358-274_a5aee68e-8dc7-4e03-af71-3a27f7508098 33358-274 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 20141115 ANDA ANDA040284 RxChange Co. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 33358-316_dd0680b7-b318-445a-b849-04b1f75af80a 33358-316 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20141125 ANDA ANDA077824 RxChange Co. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 33358-332_97e69e3c-7c76-459d-882f-327435be01c3 33358-332 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20141115 ANDA ANDA071638 RxChange Co. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 33358-342_6a61c7c9-ac81-463e-9872-0bfff0dbca95 33358-342 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20141114 ANDA ANDA076003 RxChange Co. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 33358-343_18a40110-4a36-442c-b73e-e3d1fd56837d 33358-343 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20141120 ANDA ANDA090485 RxChange Co. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 33358-364_1e1ecdbc-2371-4d40-abfd-eca669ac56a0 33358-364 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 RxChange Co. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 33358-420_94b44ddd-c19c-45d3-a779-be912f8380b3 33358-420 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20141120 ANDA ANDA077903 RxChange Co. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 33358-431_27f2d683-bf04-43f9-b431-2bb80adab6fa 33358-431 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 RxChange Co. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 33358-435_bafeb4a3-63d0-4e8f-a9fa-6c91e5b53925 33358-435 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20141121 ANDA ANDA040526 RxChange Co. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 33358-439_2d3a6610-d79e-44ef-828d-635f445e720b 33358-439 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20141127 ANDA ANDA077903 RxChange Co. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 33358-451_fb0dcb02-f3ac-4d81-9036-3896ea929348 33358-451 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141126 NDA AUTHORIZED GENERIC NDA020254 RxChange Co. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 33358-475_a9f2a4b4-a4f4-4cad-a464-3967d49dd81e 33358-475 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20141127 ANDA ANDA078155 RxChange Co. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 33358-498_ab995edd-8c46-43f0-8698-9e5fb576529c 33358-498 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20141126 ANDA ANDA090469 RxChange Co. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 33358-512_355a69d9-5b4d-4d6c-be1c-213b9e0ad096 33358-512 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20141202 ANDA ANDA090469 RxChange Co. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 33358-530_fa6804d6-91e4-404c-8237-cbc28e327ebb 33358-530 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141127 ANDA ANDA076565 RxChange Co. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 33358-536_d301ae01-f87f-4da5-9578-501702be489f 33358-536 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071221 ANDA ANDA077056 RxChange Co. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 33758-001_893a5dc0-0bae-4582-bf54-577fb09d754e 33758-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19720601 UNAPPROVED MEDICAL GAS Modern Welding Company, Inc. OXYGEN 990 mL/L 33992-0003_68ff0f72-dd31-4fd7-8863-8e4024bbd510 33992-0003 HUMAN OTC DRUG ENREGIN Anti-Blemish Cleanser SALICYLIC ACID CREAM TOPICAL 20120905 OTC MONOGRAPH FINAL part333D Greenbrier International, Inc. SALICYLIC ACID .5 g/100g 33992-0004_3e5f25e8-7a49-4215-ab35-f642edeb2139 33992-0004 HUMAN OTC DRUG Deep Cleaning Mask SALICYLIC ACID CREAM TOPICAL 20131211 OTC MONOGRAPH FINAL part333D Greenbrier International, Inc. SALICYLIC ACID .5 g/100g 33992-0010_1b8f1f1a-fd7a-4754-853b-ca5e02f9c83f 33992-0010 HUMAN OTC DRUG APRIL Bath and Shower Anti-bacterial Hand 3 Pack TRICLOSAN KIT TOPICAL 20130606 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. 33992-0016_8f7ffe20-6e80-4616-8711-3cebf63850dc 33992-0016 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20140930 OTC MONOGRAPH NOT FINAL part343 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ACETAMINOPHEN 500 mg/1 33992-0029_12342f19-468e-45a1-8072-d8311ba1edc6 33992-0029 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20140731 OTC MONOGRAPH NOT FINAL part334 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) MAGNESIUM CITRATE 1.745 g/29.6mL 33992-0054_b6724541-f874-43a6-a7da-334f73b53f72 33992-0054 HUMAN OTC DRUG XtraCare Skin Relief Oatmeal Daily Moisturizing Dimethicone LOTION TOPICAL 20140519 OTC MONOGRAPH FINAL part347 Greenbrier International DIMETHICONE 5 mg/354mg 33992-0055_5a3f9db3-e44b-4925-829a-ebe9b8e1ade3 33992-0055 HUMAN OTC DRUG Daily Moisturizing - Oatmeal Dimethicone LOTION TOPICAL 20140519 OTC MONOGRAPH FINAL part347 Greenbrier International DIMETHICONE 3 g/227g 33992-0100_04aead72-c449-4fef-bd39-d56ed1037166 33992-0100 HUMAN OTC DRUG Antibacterial Hand TRICLOSAN SOAP TOPICAL 20121205 OTC MONOGRAPH FINAL part333E Greenbrier International, Inc. TRICLOSAN 1.5 mg/mL 33992-0107_13dfaffd-007d-48f2-8c2b-5855248a4181 33992-0107 HUMAN OTC DRUG Mucus Relief Expectorant Guaifenesin TABLET ORAL 20130416 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) GUAIFENESIN 400 mg/1 33992-0109_35b0a079-c535-4e26-b043-9646facf3789 33992-0109 HUMAN OTC DRUG Mucus Relief DM Expectorant and Cough Suppressant Dextromethorphan Hydrobromide and Guaifenesin TABLET, COATED ORAL 20100106 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 33992-0113_d5b412b4-9121-42e0-8c3f-413810ade6dd 33992-0113 HUMAN OTC DRUG Assured Gas Relief Extra Strength Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20120106 OTC MONOGRAPH FINAL part332 Greenbrier International, Inc. DIMETHICONE 125 mg/1 33992-0128_7a6d1cc4-509b-4941-b1e7-6017a4f516bf 33992-0128 HUMAN OTC DRUG All Day Allergy Relief Cetirizine HCl TABLET ORAL 20121019 ANDA ANDA078427 ASSURED (Greenbrier International, Inc.) CETIRIZINE HYDROCHLORIDE 10 mg/1 33992-0129_99132b29-974e-40ae-85c5-5ae577c10378 33992-0129 HUMAN OTC DRUG All Day Allergy Relief Cetirizine HCl TABLET ORAL 20100706 ANDA ANDA078780 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) CETIRIZINE HYDROCHLORIDE 10 mg/1 33992-0159_40f92683-22bc-4b75-91bf-557ec92f56d8 33992-0159 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 33992-0183_8c8f0c4b-fdd0-49c6-a603-fc960af1df7f 33992-0183 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine, Pyrilamine maleate TABLET ORAL 20140131 OTC MONOGRAPH NOT FINAL part343 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 33992-0213_ef4f5bfb-5425-469f-ae97-0e38edef48a1 33992-0213 HUMAN OTC DRUG Pain Relief PM Extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20131130 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 33992-0268_eea39001-f67b-40a4-896c-07510e41b35d 33992-0268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20140829 OTC MONOGRAPH NOT FINAL part356 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) HYDROGEN PEROXIDE 2.65 mL/100mL 33992-0271_aba26b5d-aff6-40cc-8093-6c1fcbbad964 33992-0271 HUMAN OTC DRUG Isopropyl alcohol 50 percent Isopropyl alcohol LIQUID TOPICAL 20140731 OTC MONOGRAPH NOT FINAL part333A ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ISOPROPYL ALCOHOL 50 mL/100mL 33992-0291_ec6b8411-04b1-461b-952c-30e385fd9c04 33992-0291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 GREENBRIER INTERNATIONAL, INC. IBUPROFEN 200 mg/1 33992-0293_5f3b0889-ab08-4a2d-a8ce-753fa040ce78 33992-0293 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20040408 OTC MONOGRAPH FINAL part338 GREENBRIER INTERNATIONAL, INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 33992-0329_8ea47395-8d99-41d0-9caa-03698d3a61c6 33992-0329 HUMAN OTC DRUG Allergy Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 GREENBRIER INTERNATIONAL, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 33992-0367_9612968a-ff10-44d4-ad0b-03fb91494aa5 33992-0367 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 GREENBRIER INTERNATIONAL, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 33992-0373_e580a757-c88b-44a1-a777-5eccdf7a84a5 33992-0373 HUMAN OTC DRUG Aspirin Free Headache PM Acetaminophen and Diphenhydramine Citrate TABLET ORAL 20040607 OTC MONOGRAPH FINAL part341 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 33992-0375_3c9e9499-d749-4a61-bb2b-b30c54b899b9 33992-0375 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 GREENBRIER INTERNATIONAL, INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 33992-0413_79b2deea-0137-4322-8d3d-24568ef9afef 33992-0413 HUMAN OTC DRUG Back and Body Extra Strength Aspirin, Caffeine TABLET ORAL 20040412 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ASPIRIN; CAFFEINE 500; 32.5 mg/1; mg/1 33992-0428_c5386aae-5bdc-41cb-ab6f-c02599b2b566 33992-0428 HUMAN OTC DRUG Tension Headache Relief Acetaminophen, Caffeine CAPSULE ORAL 20070117 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 33992-0447_31a42df6-3b3e-4251-aca4-879866b51e8d 33992-0447 HUMAN OTC DRUG Pain Relief PM Extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20141130 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 33992-0453_aa7323e6-ef20-4e64-89e9-62fc9cde4ebb 33992-0453 HUMAN OTC DRUG Non-Drowsy Nasal Decongestant Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 GREENBRIER INTERNATIONAL, INC. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 33992-0464_9a636fe9-4b87-48bb-a220-45522c6f8ec2 33992-0464 HUMAN OTC DRUG Allergy Plus Sinus Headache Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET ORAL 20050615 OTC MONOGRAPH FINAL part341 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 33992-0503_88267bae-2838-4fc5-8f92-9a91c0f29bb7 33992-0503 HUMAN OTC DRUG Cold Multi-Symptom Severe Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED ORAL 20050804 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 33992-0519_3dfb0931-7f6f-4ad1-ac53-efdb6af21827 33992-0519 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN 500 mg/1 33992-0520_d5327cb0-8d60-46ca-86d2-ae1d1695f93e 33992-0520 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl CAPSULE, LIQUID FILLED ORAL 20131120 NDA NDA021855 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) LOPERAMIDE HYDROCHLORIDE 2 mg/1 33992-0527_a154390a-8be5-41d1-b68b-64e1661009e1 33992-0527 HUMAN OTC DRUG Severe Sinus Congestion and Pain Daytime Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, COATED ORAL 20050806 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 33992-0529_5ca2cfcc-b06d-4071-af41-22c6ca4fb6f8 33992-0529 HUMAN OTC DRUG Daytime Nighttime Non-Aspirin Cold Formula Multi-Symptom Acetaminophen, Chlorpehniramine HCl, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 GREENBRIER INTERNATIONAL, INC. 33992-0611_6cf1fd3d-5529-412d-9003-a06edd445f57 33992-0611 HUMAN OTC DRUG Daytime Multi-Symptom Cold/Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130201 OTC MONOGRAPH FINAL part341 Greenbrier International ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 33992-0620_f5c428a5-2121-4ce1-b79b-688ed2a67322 33992-0620 HUMAN OTC DRUG Maximum Strength Heartburn Relief Ranitidine TABLET ORAL 20130615 ANDA ANDA200536 GREENBRIER INTERNATIONAL, INC. RANITIDINE HYDROCHLORIDE 150 mg/1 33992-0621_e278b8ad-2eb0-4bd8-a455-a8a438e87f97 33992-0621 HUMAN OTC DRUG NiteTime Multi-Symptom Cold/Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130104 OTC MONOGRAPH FINAL part341 Greenbrier International ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 33992-1060_d0b7b99c-e6b2-49cc-8a46-8b1448ac8797 33992-1060 HUMAN OTC DRUG INSTANT Hand Sanitizer Extra Enriched With Vitamin E Lemon Fresh Scent ALCOHOL GEL TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-1061_4790b95f-950a-46c3-836a-c93c894ccaab 33992-1061 HUMAN OTC DRUG ASSURED Instant Hand Sanitizer WITH MOISTURIZERS Aloe Vera and Moisturizers ALCOHOL GEL TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-1062_1a7d9da9-18db-4e8d-bc50-90fa89170c49 33992-1062 HUMAN OTC DRUG INSTANT Hand Sanitizer Extra Enriched With Vitamin E Lemon Fresh Scent ALCOHOL GEL TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-1063_aafa85de-12e9-4137-86dc-de6795b466c9 33992-1063 HUMAN OTC DRUG Assured Instant Hand Sanitizer with Moisturizers Vitamin E and Aloe ALCOHOL GEL TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-1066_80136d2f-4ac5-472e-8412-9d9843800e83 33992-1066 HUMAN OTC DRUG INSTANT Hand Sanitizer Extra Enriched With Vitamin E Strawberry Scent ALCOHOL GEL TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-1067_7c2d75ec-f849-4bbf-8121-0933d6f9dee1 33992-1067 HUMAN OTC DRUG INSTANT Hand Sanitizer Extra Enriched With Vitamin E Vanilla Scent ALCOHOL GEL TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-1068_ce1589ea-725b-4b1b-ac35-f23ca10515c4 33992-1068 HUMAN OTC DRUG Assured Aloe Scented Instant Hand Sanitizer ALCOHOL GEL TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-1069_486819b2-4f1b-4143-b71c-2fe89b1002b6 33992-1069 HUMAN OTC DRUG INSTANT Hand Sanitizer with Moisturizers All In One ALCOHOL GEL TOPICAL 20110805 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-1070_53b8d261-f8ee-4932-8905-522be7a6163a 33992-1070 HUMAN OTC DRUG Assured Instant Hand Sanitizer Alcohol GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-1071_d48977d9-01ae-41b5-a2bc-3892a0cc3eb1 33992-1071 HUMAN OTC DRUG Assured Instant Hand Sanitizer With Moisturizers Vitamin E and Aloe Alcohol GEL TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-1071_dc6db4eb-7aa9-4148-a80c-f89d08d0152c 33992-1071 HUMAN OTC DRUG ASSURED Instant Hand Sanitizer WITH MOISTURIZERS Vitamin E and Aloe ALCOHOL GEL TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-1075_f634ea1c-817f-4958-b188-f4beda3c9042 33992-1075 HUMAN OTC DRUG Assured Instant Hand Sanitizer Alcohol GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-1080_4eeada69-9099-46dd-809e-7b4214f0b0c4 33992-1080 HUMAN OTC DRUG Assured Hand Sanitizer With Moisturizers ALCOHOL GEL TOPICAL 20100506 OTC MONOGRAPH FINAL part333 Greenbrier International, Inc ALCOHOL 62 mL/100mL 33992-1100_e6eebf85-48bf-453d-9f8d-0f13074d0807 33992-1100 HUMAN OTC DRUG Daytime Sinus Relief Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20131209 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 33992-1108_abe4d54d-b026-45d0-beda-2f36ffa0c4bd 33992-1108 HUMAN OTC DRUG Cocoa Butter Petrolatum LOTION TOPICAL 20110802 OTC MONOGRAPH FINAL part347 GREENBRIER INTERNATIONAL PETROLATUM 5 g/100g 33992-1129_beca4704-56ec-4d40-8daf-fc4d96a29e10 33992-1129 HUMAN OTC DRUG Oatmeal dimethicone LOTION TOPICAL 20111206 OTC MONOGRAPH FINAL part347 GREENBRIER INTERNATIONAL DIMETHICONE .15 g/100g 33992-1130_b4f420a8-9123-4fba-8440-caa501ad370d 33992-1130 HUMAN OTC DRUG anti-dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20111206 OTC MONOGRAPH FINAL part358H GREENBRIER INTERNATIONAL PYRITHIONE ZINC .05 g/100g 33992-1131_71965ff5-d37c-4908-8c3c-e3041581ae33 33992-1131 HUMAN OTC DRUG Hair and Scalp anti-dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20130508 OTC MONOGRAPH FINAL part358H GREENBRIER INTERNATIONAL PYRITHIONE ZINC 1 g/100mL 33992-1136_09ae13c6-ee4b-4a76-926c-faa203e84504 33992-1136 HUMAN OTC DRUG Assured Muscle Rub Menthol GEL TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc. MENTHOL 2.5 g/100g 33992-1200_102d4516-634f-4785-9af1-7a4233ebfb0a 33992-1200 HUMAN OTC DRUG CREAMY PETROLEUM JELLY VITAMIN E ENRICHED PETROLATUM CREAM TOPICAL 20100818 OTC MONOGRAPH FINAL part347 GREENBRIER INTERNATIONAL PETROLATUM 30 g/100g 33992-1201_06347d34-dbc3-475d-8acd-4281ccbaec46 33992-1201 HUMAN OTC DRUG Cucumber Melon Scented Hand Sanitizer Alcohol GEL TOPICAL 20120315 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1202_65838285-ea10-4893-a5c7-cb37c093a765 33992-1202 HUMAN OTC DRUG Irresistible Apple Scented Hand Sanitizer Alcohol GEL TOPICAL 20120315 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1203_98dfac3e-4231-4408-9945-914f8f8b9ce7 33992-1203 HUMAN OTC DRUG Orange Scented Hand Sanitizer Alcohol GEL TOPICAL 20120315 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1204_26dff989-3f42-4c09-a7a5-d21770c848ad 33992-1204 HUMAN OTC DRUG Pomegranate Scented Hand Sanitizer Alcohol GEL TOPICAL 20120315 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1205_b1865156-6016-410e-b580-43c6eafd9620 33992-1205 HUMAN OTC DRUG Ocean Breeze Scented Hand Sanitizer Alcohol GEL TOPICAL 20120315 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1206_0985b9a9-26b9-40bb-aca0-b4eeb5d0724a 33992-1206 HUMAN OTC DRUG Lemon Scented Hand Sanitizer Alcohol GEL TOPICAL 20120315 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1210_22a63c74-80fa-4f0b-b57d-e0f14c9ee760 33992-1210 HUMAN OTC DRUG Assured CREAMY PETROLEUM JELLY VITAMIN E ENRICHED PETROLATUM CREAM TOPICAL 20130425 OTC MONOGRAPH FINAL part347 GREENBRIER INTERNATIONAL PETROLATUM 30 g/100g 33992-1300_80a24bd9-1dcb-4e4c-ad47-1c58b7f284bc 33992-1300 HUMAN OTC DRUG Creamy Cocoa Butter Petroleum PETROLATUM JELLY TOPICAL 20100818 OTC MONOGRAPH FINAL part347 GREENBRIER INTERNATIONAL PETROLATUM 30 g/100g 33992-1306_c67b9ae5-feb9-461b-b4b9-9474f7ebc28d 33992-1306 HUMAN OTC DRUG BABYS BUTT AID ZINC OXIDE OINTMENT TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 GREENBRIER INTERNATIONAL INC ZINC OXIDE 16 g/100g 33992-1307_8c93f61f-6598-4554-ba46-6ef7c8421a14 33992-1307 HUMAN OTC DRUG ACNE SALICYLIC ACID CREAM TOPICAL 20130101 OTC MONOGRAPH FINAL part358H GREENBRIER INTERNATIONAL INC SALICYLIC ACID 14 g/100g 33992-1310_cd8ee2a9-9f7b-4271-80a3-ab0b2257bce7 33992-1310 HUMAN OTC DRUG Assured Creamy Cocoa Butter Petroleum Vitamin E Enriched PETROLATUM JELLY TOPICAL 20130425 OTC MONOGRAPH FINAL part347 GREENBRIER INTERNATIONAL PETROLATUM 30 g/100g 33992-1400_6abb0e15-f193-46d9-b4a1-8edc3a28f3c9 33992-1400 HUMAN OTC DRUG 3 Hand Sanitizers ALCOHOL KIT TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. 33992-1401_0e2420c0-9108-4dc2-97a8-7c58401e0fa7 33992-1401 HUMAN OTC DRUG Instant Hand Sanitizer Extra Enriched With Vitamin E Bead Strawberry Scent Alcohol GEL TOPICAL 20120510 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1402_b2963601-1d4a-4321-8862-03eafa043966 33992-1402 HUMAN OTC DRUG Instant Hand Sanitizer Extra Enriched With Vitamin E Bead Lemon Fresh Scent Alcohol GEL TOPICAL 20120510 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1403_9dd56ea5-656d-494a-8037-1c3b986c1fb8 33992-1403 HUMAN OTC DRUG Instant Hand Sanitizer Extra Enriched With Vitamin E Bead Vanilla Scent Alcohol GEL TOPICAL 20120510 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1410_f3484622-6425-44a5-bce7-ba246ac95d5b 33992-1410 HUMAN OTC DRUG Instant Hand Sanitizer With Moisturizers Alcohol GEL TOPICAL 20121113 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1411_24c01a03-2710-4489-9ab6-c5d43c6349f2 33992-1411 HUMAN OTC DRUG Instant Hand Sanitizer With Moisturizers (Vitamin E and Aloe) Alcohol GEL TOPICAL 20121113 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1411_3d6c1ec3-b9d0-418c-8515-2bd4a59ba0c3 33992-1411 HUMAN OTC DRUG Instant Hand Sanitizer with moisturizers (Vitamin E and aloe) ALCOHOL GEL TOPICAL 20130711 OTC MONOGRAPH NOT FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1412_9fbc5424-5dd8-42ad-90e2-d4b225ca5be5 33992-1412 HUMAN OTC DRUG Instant Hand Sanitizer with moisturizers (aloe vera and moisturizers) ALCOHOL GEL TOPICAL 20130622 OTC MONOGRAPH NOT FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1413_911f769d-6373-4fab-845b-c1bc935c9099 33992-1413 HUMAN OTC DRUG Hand Cleanse Triclosan GEL TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. TRICLOSAN .15 mg/mL 33992-1415_71262433-52f7-4209-bd54-3ec47e7b0c0b 33992-1415 HUMAN OTC DRUG 2 Pack Assured Instant Hand Sanitizer with moisturizers (Vitamin E and aloe) ALCOHOL GEL TOPICAL 20130622 OTC MONOGRAPH NOT FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1416_a666bd99-88cc-494a-92d8-e7b73b2b8aa9 33992-1416 HUMAN OTC DRUG 3 Pack Instant Hand Sanitizer with moisturizers ALCOHOL GEL TOPICAL 20130829 OTC MONOGRAPH NOT FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1417_44e146a4-a06a-463a-bc68-4a42c99f57d1 33992-1417 HUMAN OTC DRUG 3 Pack Instant Hand Sanitizer with moisturizers Aloe Scented ALCOHOL GEL TOPICAL 20130829 OTC MONOGRAPH NOT FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1418_d08bbd39-aa61-40d6-acf1-b1a06e6bd048 33992-1418 HUMAN OTC DRUG 3 Pack Instant Hand Sanitizer with moisturizers Lavender Scented ALCOHOL GEL TOPICAL 20130829 OTC MONOGRAPH NOT FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL 33992-1500_5d1d1964-287e-44cc-aefb-0186ea48cc26 33992-1500 HUMAN OTC DRUG 3 HAND SANITIZERS KIT ALCOHOL KIT TOPICAL 20120815 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. 33992-1579_a68fda01-375a-4303-8bd5-0cabc8e13183 33992-1579 HUMAN OTC DRUG Antibacterial Hand - Ocean Fresh Scent TRICLOSAN SOAP TOPICAL 20110509 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. TRICLOSAN .15 mL/100mL 33992-1581_4c583cc0-74e5-486e-bfe1-67855e37dbda 33992-1581 HUMAN OTC DRUG Antibacterial Hand - Strawberry Pomegranate Scent TRICLOSAN SOAP TOPICAL 20110509 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. TRICLOSAN .15 mL/100mL 33992-1889_bdfcac69-a9c7-485f-8d70-c765bb8fc1bb 33992-1889 HUMAN OTC DRUG ASSURED PAIN RELIEF HOT PATCH MENTHOL, CAPSICUM OLEORESIN PATCH TOPICAL 20130331 OTC MONOGRAPH NOT FINAL part348 GREENBRIER INTERNATIONAL, INC. CAPSAICIN; MENTHOL 8.3; 30 mg/1; mg/1 33992-2000_04a167c1-bec6-4833-bda7-b6e0bec526cd 33992-2000 HUMAN OTC DRUG MOISTURIZING AND CLEANSING ACNE WIPES SALICYLIC ACID LIQUID TOPICAL 20110519 OTC MONOGRAPH FINAL part333D Greenbrier International, Inc SALICYLIC ACID .5 g/100g 33992-2013_eecf928a-3e8a-4966-81b2-225df1dfa282 33992-2013 HUMAN OTC DRUG Assured Feminine Anti-itch Benzocaine Benzalkonium chloride CREAM TOPICAL 20130215 OTC MONOGRAPH NOT FINAL part348 Greenbrier International BENZALKONIUM CHLORIDE; BENZOCAINE 130; 5 mg/100g; g/100g 33992-2100_7be45e22-4ccd-4582-a939-3b464bae277e 33992-2100 HUMAN OTC DRUG Antibacterial Moist Wipe BENZALKONIUM CHLORIDE SWAB TOPICAL 20121010 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZALKONIUM CHLORIDE 1 mg/mL 33992-2150_ef754139-6376-4c6d-b9a4-bb284a9d1208 33992-2150 HUMAN OTC DRUG Acne Wipes SALICYLIC ACID SWAB TOPICAL 20121211 OTC MONOGRAPH FINAL part333D Greenbrier International, Inc. SALICYLIC ACID 5 mg/mL 33992-2270_36f699c7-02ab-464e-b4ac-9e256c6c6e86 33992-2270 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET ORAL 20130331 OTC MONOGRAPH FINAL part343 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ASPIRIN 81 mg/1 33992-2300_2fe02208-dc55-4086-ac3f-fff1196d2144 33992-2300 HUMAN OTC DRUG Sleep-Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20100706 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 33992-2360_9aa8bcd7-757b-4c17-adbe-fcedc4a5087c 33992-2360 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 33992-3000_58255987-caad-42bd-ad27-11cf90127886 33992-3000 HUMAN OTC DRUG ASSURED FIRST AID ANTISEPTIC ADHESIVE BANDAGE BENZALKONIUM CHLORIDE PATCH TOPICAL 20110127 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZALKONIUM CHLORIDE .1 mg/100mg 33992-3001_142abc1b-4875-480e-9ded-bb3dec11b3a0 33992-3001 HUMAN OTC DRUG 2-Pack Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 36.7 mL/59.2mL 33992-3002_af002259-a5a8-4703-9b61-bf4593f269f7 33992-3002 HUMAN OTC DRUG Sweet Pea Blossom Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 147 mL/237mL 33992-3003_e032928d-87d5-49b2-990d-2ada4da5ac53 33992-3003 HUMAN OTC DRUG Cucumber Melon Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 147 mL/237mL 33992-3004_4197b5bb-db51-4c34-ba3a-8b618da54dde 33992-3004 HUMAN OTC DRUG Warm Vanilla Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 147 mL/237mL 33992-3005_53d3a41f-c439-43ed-a5f6-c59ed1ba346b 33992-3005 HUMAN OTC DRUG Hand Sanitizer with Moisturizers Ethyl Alcohol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 147 mL/237mL 33992-3006_2252f85c-2ea9-4912-b36c-e5498db0a8c8 33992-3006 HUMAN OTC DRUG Hand Sanitizer with Moisturizers Vitamin E and Aloe Ethyl Alcohol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 147 mL/237mL 33992-3007_e8f23c6d-827a-4106-8a11-3da9b0a148be 33992-3007 HUMAN OTC DRUG Ice Cold Topical Analgesic Gel Menthol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc. MENTHOL 2.84 mg/227mg 33992-3008_bd638c06-6942-4285-95fc-9c8d1feab991 33992-3008 HUMAN OTC DRUG Hand Cleanse Refill Triclosan GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. TRICLOSAN 7.5 mg/500mg 33992-3009_48242043-5c5f-4ddf-a477-e797a6a6eacf 33992-3009 HUMAN OTC DRUG Hand Cleanse Triclosan GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. TRICLOSAN 7.5 mg/500mg 33992-3010_3bf8eca3-bf47-4b65-8838-7fbb5f6b45fb 33992-3010 HUMAN OTC DRUG Hand Cleanse - Ocean Fresh Triclosan GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. TRICLOSAN 7.5 mg/500mg 33992-3011_ad81fe94-ad57-4456-ba5d-2dc429005de7 33992-3011 HUMAN OTC DRUG Hand Cleanse - Strawberry Pomegranate Triclosan GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. TRICLOSAN 7.5 mg/500mg 33992-4250_c430ecee-c823-4dcc-a896-13be219c25a1 33992-4250 HUMAN OTC DRUG Assured Instant Hand Sanitizer Spray Alcohol SPRAY TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-4947_6cf2ac78-393d-4fb7-b76a-d7e7643e50ea 33992-4947 HUMAN OTC DRUG Assured Hand Sanitizer with Vitamin E Ethyl Alcohol LIQUID TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part333A Greenbrier International Inc. ALCOHOL 70 mL/100mL 33992-4948_bb3e4991-f906-454b-857c-9b5ada6a2e80 33992-4948 HUMAN OTC DRUG Assured Hand Sanitizer with Aloe Vera Ethyl Alcohol LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333A Greenbrier International Inc. ALCOHOL 62 mL/100mL 33992-4949_196a6639-566d-4d98-b189-71a06df1a716 33992-4949 HUMAN OTC DRUG Assured Hand Sanitizer with Vitamin E Ethyl Alcohol LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333A Greenbrier International Inc. ALCOHOL 62 mL/100mL 33992-4950_26dd3fbf-25f6-4728-ad4e-bc573393d2e4 33992-4950 HUMAN OTC DRUG APRIL Bath and Shower Cucumber Melon Scented Antibacterial HAND SANITIZER ALCOHOL LIQUID TOPICAL 20120113 OTC MONOGRAPH FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-4951_cb0693b3-9de1-4738-8676-3114c85d8999 33992-4951 HUMAN OTC DRUG APRIL Bath and Shower Sweet Pea Scented Antibacterial HAND SANITIZER ALCOHOL LIQUID TOPICAL 20120113 OTC MONOGRAPH FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-4952_e2350be6-7622-47ad-8f51-4de89cd8c2a6 33992-4952 HUMAN OTC DRUG APRIL Bath and Shower Warm Vanilla Sugar Scented Antibacterial HAND SANITIZER ALCOHOL LIQUID TOPICAL 20120114 OTC MONOGRAPH FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-5000_71923ad4-3b4d-4fca-900c-c03b5bbb31a1 33992-5000 HUMAN OTC DRUG Antibacterial Wet Wipes With Aloe BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131017 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZALKONIUM CHLORIDE .115 g/100g 33992-5000_988c5768-e15f-472b-b6d7-f2c4160fd78a 33992-5000 HUMAN OTC DRUG Antibacterial Wet Wipes With Aloe BENZALKONIUM CHLORIDE LIQUID TOPICAL 20110530 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZALKONIUM CHLORIDE .115 g/100g 33992-5111_441b7daa-69dc-42d7-8093-ee3eaf4167a6 33992-5111 HUMAN OTC DRUG ASSURED Antiseptic Wet Wipes Vitamin E and Aloe BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130819 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZALKONIUM CHLORIDE .115 g/100g 33992-5561_2dd3db62-21f0-4e80-ad23-d6fab0ee2455 33992-5561 HUMAN OTC DRUG Pain Relief PM Extra Relief Acetaminophen 500 mg, Diphenhydramine HCl 25 mg TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 33992-6000_d7e03762-ab8e-44cd-bc1f-439b8a7605da 33992-6000 HUMAN OTC DRUG Assured Alcohol Cleansing Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20110223 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ISOPROPYL ALCOHOL 70 g/100g 33992-6156_1a654b9f-0feb-4b16-b5b7-e63d89746988 33992-6156 HUMAN OTC DRUG Assured Pain Relief Hot Menthol Menthol PATCH TOPICAL 20141017 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc CAPSAICIN; MENTHOL 8.3; 30 mg/100mg; mg/100mg 33992-6159_b761f1a5-0918-4289-8f62-e8cb313779b7 33992-6159 HUMAN OTC DRUG Assured Cold N Hot Pain Relief Menthol Menthol PATCH TOPICAL 20141017 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc MENTHOL 5 mg/100mg 33992-6775_32fe2ef6-4278-4705-9d54-7eb64ec3d23a 33992-6775 HUMAN OTC DRUG ANTIBACTERIAL BANDAGE benzalkonium chloride SWAB TOPICAL 20130816 OTC MONOGRAPH NOT FINAL part333A Greenbrier International BENZALKONIUM CHLORIDE .12 g/100g 33992-7000_909acbe9-8d19-4a57-bb23-cc5bddb052fc 33992-7000 HUMAN OTC DRUG Extra Strength Cold n Hot Pain Relief Medicated MENTHOL PATCH TOPICAL 20110303 OTC MONOGRAPH NOT FINAL part348 Greenbrier International , Inc. MENTHOL 5 g/100g 33992-7993_b8e4a1f5-fd56-45e9-8f7a-c0f5a6db2449 33992-7993 HUMAN OTC DRUG Assured Ice Cold Topical Analgesic CAMPHOR, MENTHOL GEL TOPICAL 20110706 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc. CAMPHOR (SYNTHETIC); MENTHOL 3; 1.25 g/100g; g/100g 33992-7994_60d86534-5a3e-4e06-ad00-f9a2aaed181c 33992-7994 HUMAN OTC DRUG ASSURED ICE COLD TOPICAL ANALGESIC MENTHOL GEL TOPICAL 20110706 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc. MENTHOL 1.25 g/100g 33992-7995_2e1b7dd0-3032-44a3-8608-dda66dbb75be 33992-7995 HUMAN OTC DRUG Assured Vaporizing Chest Rub CAMPHOR, EUCALYPTUS OIL, MENTHOL OINTMENT TOPICAL 20110706 OTC MONOGRAPH FINAL part341 Greenbrier International, Inc. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 g/100g; g/100g; g/100g 33992-8000_b3593d76-3ebd-4c16-bcdd-44cf22ffaa12 33992-8000 HUMAN OTC DRUG KLAR and DANVER ANTIBACTERIAL HAND BENZALKONIUM CHLORIDE SOAP TOPICAL 20130828 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZALKONIUM CHLORIDE 1 mg/mL 33992-8376_1e70318e-6b31-438f-bb69-4c9aa8e488ed 33992-8376 HUMAN OTC DRUG ASSURED ADVANCED RELIEF EYE DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL SOLUTION OPHTHALMIC 20130228 OTC MONOGRAPH FINAL part349 GREENBRIER INTERNATIONAL, INC. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL 33992-8463_dbce6c7d-a94c-48b4-9eb3-776c98f5b7e0 33992-8463 HUMAN OTC DRUG Assured Extra Strength Cold n hot Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc. MENTHOL 750 mg/1 33992-8684_1e94fd99-7232-4dae-96b4-cdece5bd3504 33992-8684 HUMAN OTC DRUG ASSURED NASAL RELIEF ORIGINAL OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20110308 OTC MONOGRAPH FINAL part341 GREENBRIER INTERNATIONAL, INC. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 33992-8685_e64cc0cf-0d97-4258-b16b-c1557c3f4c0e 33992-8685 HUMAN OTC DRUG Assured Nasal Relief OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20130430 OTC MONOGRAPH FINAL part341 Greenbrier International, Inc. OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL 33992-8805_4b9e5e0f-e466-4ecc-a99f-6c7a236cd334 33992-8805 HUMAN OTC DRUG SUNSHINY DAY SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-8806_1a2c50ca-1c9d-4411-af7e-53c27c8c16d8 33992-8806 HUMAN OTC DRUG OUT OF THE BLUE SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-8807_0e69f3c4-842f-40b5-8225-1a985c855a69 33992-8807 HUMAN OTC DRUG FRESH SPLASH SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-8808_27a0786f-e404-4503-aa9f-3d2bfd41c0ca 33992-8808 HUMAN OTC DRUG SNAPPY APPLE SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL 33992-8810_498d93ef-7730-4314-b214-9ff9c989ad8a 33992-8810 HUMAN OTC DRUG ANTI-BACTERIAL HAND SANITIZER 2 PACK BLUE DAY SCENTED ALCOHOL KIT 20140615 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. 33992-8811_ad1eefdb-5104-49e9-a5e4-31de06985f36 33992-8811 HUMAN OTC DRUG ANTI-BACTERIAL HAND SANITIZER 2 PACK SPLASH APPLE SCENTED ALCOHOL KIT 20140615 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. 33992-8815_6e6c97bc-782d-4700-8ee1-d724d32bddc4 33992-8815 HUMAN OTC DRUG ACNE FIGHTING ROLL ON GEL SALICYLIC ACID GEL TOPICAL 20140715 OTC MONOGRAPH FINAL part333D Greenbrier International, Inc. SALICYLIC ACID 2 g/100g 33992-8816_0a82036c-0e08-4005-964e-d23eaa3fb822 33992-8816 HUMAN OTC DRUG ANTI ITCH MENTHOL LOTION TOPICAL 20140915 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc. MENTHOL .15 g/100g 33992-9376_051c56f5-0fc6-4dfb-9750-2c21d6a249e4 33992-9376 HUMAN OTC DRUG ASSURED ORIGINAL RELIEF EYE TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20130228 OTC MONOGRAPH FINAL part349 GREENBRIER INTERNATIONAL, INC. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 34022-101_1a7f1497-83da-445e-9cca-59e979b986e3 34022-101 HUMAN OTC DRUG DAY CREAM MATTIFYING HYDRATOR SPF 25 OCTINOXATE AVOBENZONE LOTION TOPICAL 20120121 OTC MONOGRAPH FINAL part352 MOSAIC MARKETING PARTNERS LLC AVOBENZONE; OCTINOXATE 1.7; 6.6 g/100mL; g/100mL 34022-102_dd8f4566-e8ae-4cd5-ae41-60017d644faf 34022-102 HUMAN OTC DRUG DAY CREAM REPLENISHING HYDRATOR SPF 25 OCTINOXATE AVOBENZONE LOTION TOPICAL 20120121 OTC MONOGRAPH FINAL part352 MOSAIC MARKETING PARTNERS LLC AVOBENZONE; OCTINOXATE 1.7; 6.6 g/100mL; g/100mL 34057-001_7f0330d3-833e-4372-b47e-3a771d3c4a45 34057-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19770101 NDA NDA205849 Oxarc, Inc. OXYGEN 990 mL/L 34057-006_43f9dc95-1601-4182-a8e5-cc34b711db81 34057-006 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19770101 NDA NDA205847 Oxarc, Inc. AIR 1000 mL/L 34057-010_731f7e71-888a-4aa8-a4a3-9a4e098d13c8 34057-010 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19770101 NDA NDA206009 Oxarc, Inc. NITROUS OXIDE 990 mL/L 34057-014_1d417e02-5afc-46af-9dbe-114a58a0f41c 34057-014 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19770101 NDA NDA205850 Oxarc, Inc. NITROGEN 990 mL/L 34330-001_482828d4-0ec3-4010-bb1b-93bc292983c0 34330-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Compressed Gases Inc OXYGEN 99 L/100L 34330-002_44f86ed5-d087-4a14-bf12-f2d07acf75cb 34330-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19800101 UNAPPROVED MEDICAL GAS Compressed Gases Inc NITROGEN 99 L/100L 34330-003_c4b4e135-e6dc-4ee0-b7e8-03c081ca8ebb 34330-003 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19800101 UNAPPROVED MEDICAL GAS Compressed Gases Inc NITROUS OXIDE 99 L/100L 34331-202_c0a67c7f-df00-481e-b968-1818d99e1b23 34331-202 HUMAN OTC DRUG LipiGesic M Feverfew and Ginger GEL SUBLINGUAL 20110808 UNAPPROVED HOMEOPATHIC PuraMed BioScience, Inc. FEVERFEW; GINGER 3; 2 [hp_X]/mL; [hp_X]/mL 34362-0230_8594a892-1147-4af7-b175-a5534ef2a1ac 34362-0230 HUMAN OTC DRUG The Natural Dentist Sensitivity Fluoride PASTE, DENTIFRICE DENTAL 20110501 OTC MONOGRAPH NOT FINAL part356 Caldwell Consumer Health LLC POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 34362-0231_d4e96c23-9636-4f32-9f5f-799fecd59b63 34362-0231 HUMAN OTC DRUG The Natural Dentist Berry Blast Fluoride PASTE, DENTIFRICE DENTAL 20110501 OTC MONOGRAPH FINAL part355 Caldwell Consumer Health LLC SODIUM FLUORIDE .243 g/100g 34362-0232_051f0a92-c9f7-4c8f-9661-05927f0500e4 34362-0232 HUMAN OTC DRUG The Natural Dentist Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110501 OTC MONOGRAPH FINAL part355 Caldwell Consumer Health LLC SODIUM FLUORIDE .243 g/100g 34362-0233_830919e6-9e5a-4d54-bd01-0efd8af13445 34362-0233 HUMAN OTC DRUG The Natural Dentist Groovy Grape Fluoride PASTE, DENTIFRICE DENTAL 20110501 OTC MONOGRAPH FINAL part355 Caldwell Consumer Health LLC SODIUM FLUORIDE .243 g/100g 34362-0234_97b1099c-5ccd-4f36-b44b-f707db5cc318 34362-0234 HUMAN OTC DRUG The Natural Dentist Peppermint Twist Fluoride PASTE, DENTIFRICE DENTAL 20110501 OTC MONOGRAPH FINAL part355 Caldwell Consumer Health LLC SODIUM FLUORIDE .243 g/100g 34362-0235_e133eb25-0f73-4be3-b61a-a05f3e9526b6 34362-0235 HUMAN OTC DRUG The Natural Dentist Orange Zest Fluoride PASTE, DENTIFRICE DENTAL 20110501 OTC MONOGRAPH FINAL part355 Caldwell Consumer Health LLC SODIUM FLUORIDE .243 g/100g 34362-0236_46ee0bb5-5157-4b3c-be45-9d21fdc02919 34362-0236 HUMAN OTC DRUG The Natural Dentist Peppermint Sage Peppermint PASTE, DENTIFRICE DENTAL 20110501 OTC MONOGRAPH NOT FINAL part356 Caldwell Consumer Health LLC PEPPERMINT OIL; SAGE OIL .1; .02 g/100g; g/100g 34362-0270_8764e374-b93f-4ec0-8177-7e880449b2ec 34362-0270 HUMAN OTC DRUG The Natural Dentist Peppermint Twist Fluoride PASTE, DENTIFRICE DENTAL 20110501 OTC MONOGRAPH FINAL part355 Caldwell Consumer Health LLC SODIUM FLUORIDE .243 g/100g 34362-0300_9a4c2790-9192-4949-8529-c1b19a8a3f66 34362-0300 HUMAN OTC DRUG Conceptrol Options Nonoxynol GEL VAGINAL 20110501 OTC MONOGRAPH NOT FINAL part333A Caldwell Consumer Health LLC NONOXYNOL-9 4 g/100g 34362-0302_7a842e7f-9413-47c6-a062-bf9b6ce7cf2f 34362-0302 HUMAN OTC DRUG Gynol II Extra Strength Nonoxynol GEL VAGINAL 20110501 OTC MONOGRAPH NOT FINAL part333A Caldwell Consumer Health LLC NONOXYNOL-9 3 g/100g 34460-6001_f69b1715-0d7b-41c7-892a-53e5062f3f2f 34460-6001 HUMAN OTC DRUG Red Apple Antibacterial Hand Triclosan SOAP TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part333A Zhejiang Blue Dream Cosmetics Co., Ltd. TRICLOSAN .115 g/100g 34460-6002_f73a368a-32fe-40dd-aa8e-0eeca4ec630f 34460-6002 HUMAN OTC DRUG Pear Barlet Antibacterial Hand Triclosan SOAP TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part333 Zhejiang Blue Dream Cosmetics Co., Ltd. TRICLOSAN .115 g/100g 34460-6003_80b844e6-de58-4283-ac67-0b9404fb9299 34460-6003 HUMAN OTC DRUG Lemon Zest Antibacterial Hand Triclosan SOAP TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part333 Zhejiang Blue Dream Cosmetics Co., Ltd. TRICLOSAN .115 g/100g 34460-6004_23ffa693-24ca-441d-8d95-385fcd469c9b 34460-6004 HUMAN OTC DRUG Mandarin Orange Antibacterial Hand Triclosan SOAP TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part333 Zhejiang Blue Dream Cosmetics Co., Ltd. TRICLOSAN .115 g/100g 34460-6005_42df1a89-9240-4c14-aac1-27ee77306eaa 34460-6005 HUMAN OTC DRUG Frosted Berries and Cream Sanitizer Pen ALCOHOL LIQUID TOPICAL 20100807 OTC MONOGRAPH NOT FINAL part333 Zhejiang Blue Dream Cosmetics Co., Ltd. ALCOHOL 62 g/100g 34460-6006_a725fba6-9f92-43a5-911b-299f35619180 34460-6006 HUMAN OTC DRUG Sweet Candy Kiss Sanitizer Pen ALCOHOL LIQUID TOPICAL 20100807 OTC MONOGRAPH NOT FINAL part333 Zhejiang Blue Dream Cosmetics Co., Ltd. ALCOHOL 62 g/100g 34460-6007_2079c0da-cb7f-4a02-8d19-c49a3b85cba5 34460-6007 HUMAN OTC DRUG Icee Blue Raspberry Scented Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100807 OTC MONOGRAPH NOT FINAL part333E Zhejiang Blue Dream Cosmetics Co., Ltd. ALCOHOL 62 g/100g 34460-6008_6650b768-c7b7-407b-bda7-410832b25f34 34460-6008 HUMAN OTC DRUG Icee Strawberry Scented Hand Sanitizer ALCOHOL LIQUID TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Zhejiang Blue Dream Cosmetics Co., Ltd. ALCOHOL 62 g/100g 34460-6009_8dfdad81-4f0d-4187-af6e-0c48d2d76403 34460-6009 HUMAN OTC DRUG Icee White Cherry Scented Hand Sanitizer ALCOHOL LIQUID TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Zhejiang Blue Dream Cosmetics Co., Ltd. ALCOHOL 62 g/100g 34605-5001_22ca8f44-40ee-42e9-83e1-72eca1006e9b 34605-5001 HUMAN OTC DRUG NOSMO KING smoking deterrent clove TABLET, SOLUBLE ORAL 20100317 UNAPPROVED DRUG OTHER Nosmo Co., Ltd CLOVE; LEMON; MENTHOL .11875; .001; .0015 g/1; g/1; g/1 34605-6001_f0f96e67-c784-4eef-805a-631bd0097124 34605-6001 HUMAN OTC DRUG Nosmotea smoking deterrent clove tea POWDER ORAL 20100306 UNAPPROVED DRUG OTHER Nosmo Co., Ltd CLOVE; LEMON; MENTHOL 20; 1; 1.5 mg/g; mg/g; mg/g 34645-2105_e3fdb5f5-3c56-413e-978f-23265ea4bf86 34645-2105 HUMAN OTC DRUG Lemon Glycerin Glycerin SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part347 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. GLYCERIN .5 mL/mL 34645-2308_e9ac123b-da39-4e8b-8013-c87324f87c5b 34645-2308 HUMAN OTC DRUG Acetone Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL 34645-2325_1cec7752-dd43-4d5b-a8f7-478870f773ae 34645-2325 HUMAN OTC DRUG Acetone Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL 34645-2608_784466af-9460-4ca6-af0f-d80cef1c3163 34645-2608 HUMAN OTC DRUG Personal Cloth Wipes Witch Hazel SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part346 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. WITCH HAZEL .5 mL/mL 34645-2712_6b3b681d-52c1-473b-bfe2-a1611ae7c624 34645-2712 HUMAN OTC DRUG PCMX Surgical Scrub Chloroxylenol SPONGE TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. CHLOROXYLENOL .04 mL/mL 34645-2720_972a33ae-d490-42d4-8f1e-6794cca7f185 34645-2720 HUMAN OTC DRUG PCMX Surgical Scrub Chloroxylenol SPONGE TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. CHLOROXYLENOL .033 mL/mL 34645-3008_44e02819-69a8-4602-a787-cb4734b10191 34645-3008 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL 34645-3018_1ecafc42-d233-4330-aaf0-a45518aab400 34645-3018 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL 34645-3025_3fbd0bc6-3aa0-4660-8448-f2dbd160b5c2 34645-3025 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL 34645-3026_354c973b-e558-4d38-b632-53c3bed72a2b 34645-3026 HUMAN OTC DRUG Isopropyl Alcohol Surgical Scrub Isopropyl Alcohol SPONGE TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .07 mL/mL 34645-3030_a6ce0cc2-d633-433a-8f71-541d2c070d11 34645-3030 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20060101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL 34645-3031_6283ee95-1a7c-498a-aae2-7d54e08e3777 34645-3031 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20060101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL 34645-3110_c1f9e7ba-70cc-4538-b5c7-18cf59b33be5 34645-3110 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL 34645-3111_7b184b14-4078-42d3-a33f-225b98c304a3 34645-3111 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL 34645-4000_5a2f0be9-4622-48a3-be3c-30afaffb3845 34645-4000 HUMAN OTC DRUG Povidone-Iodine Povidone-Iodine SWAB TOPICAL 20080101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mL/mL 34645-4001_ef2df7a9-fb9c-481c-b29a-76908060ad60 34645-4001 HUMAN OTC DRUG Povidone-Iodine Povidone-Iodine SWAB TOPICAL 20080101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mL/mL 34645-4002_654d88ea-2d79-4e90-8721-b255690c48e5 34645-4002 HUMAN OTC DRUG Povidone-Iodine Prep Pad Povidone-Iodine SWAB TOPICAL 20080101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mL/mL 34645-4008_a632cd72-0972-412c-aa69-f75acfdfb6ca 34645-4008 HUMAN OTC DRUG Povidone Iodine Prep Pad Povidone-Iodine SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mL/mL 34645-4009_a825e6e5-4d28-4284-a82b-b1ae96af7934 34645-4009 HUMAN OTC DRUG Povidone Iodine Povidone Iodine SOLUTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .075 mL/mL 34645-4010_7a452fea-9eb7-4938-bfae-752af3478ab5 34645-4010 HUMAN OTC DRUG Povidone Iodine Impregnated Povidone Iodine SPONGE TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mL/mL 34645-4012_072595ff-6bf2-4d21-9411-ce7f69822f19 34645-4012 HUMAN OTC DRUG Povidone Iodine Surgical Scrub Povidone Iodine SPONGE TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .09 mL/mL 34645-4019_bacff821-f7fb-41c3-b8d2-4b826e1a9e1d 34645-4019 HUMAN OTC DRUG Povidone Iodine Povidone-Iodine SWAB TOPICAL 20100301 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mL/mL 34645-4020_5a5c22cf-daa7-4000-a52f-64b6320f923b 34645-4020 HUMAN OTC DRUG Povidone Iodine Impregnated Povidone Iodine SPONGE TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .75 mL/mL 34645-4021_c3ef62f6-a88f-4f33-8071-d82c441c2236 34645-4021 HUMAN OTC DRUG Povidone Iodine Surgical Scrub Povidone Iodine SPONGE TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mL/mL 34645-4025_eac5235a-f2ee-468e-af45-116ee28219b3 34645-4025 HUMAN OTC DRUG Povidone Iodine Scrub Povidone-Iodine SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .075 mL/mL 34645-4050_800fe97b-6508-4c55-af4f-d936b3894dd8 34645-4050 HUMAN OTC DRUG Povidone Iodine Scrub Povidone-Iodine SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mL/mL 34645-4059_d7388a28-8fc5-47fe-b624-1a1d0dfdc817 34645-4059 HUMAN OTC DRUG Povidone Iodine Povidone Iodine SOLUTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mL/mL 34645-4109_4918a5d0-cfdf-467d-9867-02e636fc0b08 34645-4109 HUMAN OTC DRUG Povidone Iodine Povidone Iodine SOLUTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mL/mL 34645-4112_b44cfd3f-7401-4d4e-94f0-7b4855eeb4d7 34645-4112 HUMAN OTC DRUG Povidone Iodine Surgical Scrub Povidone Iodine SPONGE TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .05 mL/mL 34645-4188_89d5efc0-6583-4a4c-b14d-cd363c667be2 34645-4188 HUMAN OTC DRUG Povidone Iodine Povidone Iodine SOLUTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mL/mL 34645-4242_4d58527e-8d95-4331-b9a0-3d1dd7357e7a 34645-4242 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20060101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL 34645-5000_e9fead15-cc40-4d58-98f2-6b21ac68965b 34645-5000 HUMAN OTC DRUG First Aid Antiseptic Benzalkonium Chloride SWAB TOPICAL 20060101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co.,Ltd BENZALKONIUM CHLORIDE .0013 mL/mL 34645-5001_62705c80-c4b5-42c1-af1b-fba169692bcc 34645-5001 HUMAN OTC DRUG Wash Benzalkonium Chloride SWAB TOPICAL 20060101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co.,Ltd BENZALKONIUM CHLORIDE .0013 mL/mL 34645-5002_60609692-3bf4-4c40-b5bd-00522b7ae659 34645-5002 HUMAN OTC DRUG Obstetrical Antiseptic Benzalkonium Chloride SWAB TOPICAL 20060101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co.,Ltd BENZALKONIUM CHLORIDE .0013 mL/mL 34645-5008_a2343700-b31f-46cd-b339-37d83127aa4a 34645-5008 HUMAN OTC DRUG BZK Benzalkonium Chloride SWAB TOPICAL 20060101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co.,Ltd BENZALKONIUM CHLORIDE .00133 mL/mL 34645-5018_2ef3d884-5939-4747-9646-9e641dd688b6 34645-5018 HUMAN OTC DRUG First Aid Antiseptic Benzalkonium Chloride SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. BENZALKONIUM CHLORIDE .0013 mL/mL 34645-5028_cbb3268f-3bc9-4b45-9b22-ed84057d0007 34645-5028 HUMAN OTC DRUG Wash Towelette Benzalkonium Chloride SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. BENZALKONIUM CHLORIDE .0013 mL/mL 34645-5038_c9504f3d-9389-4316-9cee-eec48eeae63e 34645-5038 HUMAN OTC DRUG OB Cleansing Towelette Benzalkonium Chloride SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. BENZALKONIUM CHLORIDE .0013 mL/mL 34645-5048_8febc9b7-cf3e-4e2e-b0e6-92c1f536e6f1 34645-5048 HUMAN OTC DRUG Wash-Up Towelette Benzalkonium Chloride SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. BENZALKONIUM CHLORIDE .0013 mL/mL 34645-7008_80ce5000-d152-4de5-b900-43ef398a9243 34645-7008 HUMAN OTC DRUG Sting Relief Pads Benzocaine SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part346 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. BENZOCAINE .06 mL/mL 34645-8030_ffab3590-e3b1-44fb-86fe-73c9221d7635 34645-8030 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20100501 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. HYDROGEN PEROXIDE .03 mL/mL 34666-001_46f6d22c-dded-41d1-b4dc-0a209dc167f1 34666-001 HUMAN OTC DRUG Arnica Montana Nartex Arnica montana, Hamamelis Virginiana CREAM TOPICAL 20070601 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ARNICA MONTANA; HAMAMELIS VIRGINIANA LEAF 1.73; .0178 g/29.7g; g/29.7g 34666-002_3332bff9-00e3-4f1d-b71e-36728d7793bc 34666-002 HUMAN OTC DRUG APETYL Syrup Avena sativa 3X, China officinalis 3X and Hydrastis canadensis 3X SYRUP ORAL 20090730 UNAPPROVED HOMEOPATHIC Nartex Laboratorios Homeopaticos, S.A. De C.V. AVENA SATIVA POLLEN; CINCHONA OFFICINALIS; HYDRASTIS CANADENSIS EXTRACT 3; 3; 3 [HP_X]/240mL; [HP_X]/240mL; [HP_X]/240mL 34666-003_7cb92dcb-a2f4-4eef-b2cb-8853e1bd17ab 34666-003 HUMAN OTC DRUG Calmex Ignatia Amara, Kali Phosphoricum, Passiflora Incarnata, Valeriana Officinalis TABLET ORAL 20090801 UNAPPROVED HOMEOPATHIC Nartex Laboratorios Homeopaticos, S.A. De C.V. PASSIFLORA INCARNATA; STRYCHNOS IGNATII SEED; VALERIAN 3; 3; 3 [HP_X]/1; [HP_X]/1; [HP_X]/1 34666-004_ba3ee27f-5657-47cb-83aa-e78dd856bff6 34666-004 HUMAN OTC DRUG LIBERATE Nux Vomica TABLET ORAL 20090801 UNAPPROVED HOMEOPATHIC Nartex Laboratorios Homeopaticos, S.A. De C.V. STRYCHNOS NUX-VOMICA SEED 50 [HP_X]/1 34666-005_1302f55c-64e8-42c5-85f2-54778e647c92 34666-005 HUMAN OTC DRUG CALM-ITO Coffea Cruda, Cypripendium, Hyoscyamus and Matricaria Chamomilla TABLET ORAL 20090801 UNAPPROVED HOMEOPATHIC Nartex Laboratorios Homeopaticos, S.A. De C.V. COFFEE BEAN; CYPRIPEDIUM PUBESCENS; HYOSCYAMUS; MATRICARIA 3; 3; 3; 3 [HP_X]/1; [HP_X]/1; [HP_X]/1; [HP_X]/1 34666-006_9669dc0c-505f-4305-ae90-aa75d605521f 34666-006 HUMAN OTC DRUG Revitalix China officinalis, Ferrum Phosphoricum and Medicago Sativa SYRUP ORAL 20090801 UNAPPROVED HOMEOPATHIC Nartex Laboratorios Homeopaticos, S.A. De C.V. CINCHONA OFFICINALIS; MEDICAGO SATIVA LEAF 8; 8 [HP_X]/240mL; [HP_X]/240mL 34666-007_5be61ec6-280d-457a-8145-28310854d37a 34666-007 HUMAN OTC DRUG Arnica Montana Nartex Arnica Montana, Hamamelis virginica OINTMENT TOPICAL 20101223 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ARNICA MONTANA; HAMAMELIS VIRGINIANA LEAF 1.66; 1.66 g/28g; g/28g 34666-008_d9eb20ba-b92e-4bad-b846-b882ee59042c 34666-008 HUMAN OTC DRUG Simplex Passiflora incarnata, Ignatia Amara, Valeriana Officinalis TABLET ORAL 20101223 UNAPPROVED HOMEOPATHIC Nartex Laboratories PASSIFLORA INCARNATA FLOWER; STRYCHNOS IGNATII SEED; VALERIAN 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-009_0291dd0a-9245-4915-a837-95993343217e 34666-009 HUMAN OTC DRUG Revitalix Medicago Sativa L., Cinchona Officinalis L., Ferrosoferric Phosphate SYRUP ORAL 20140516 UNAPPROVED HOMEOPATHIC Nartex Laboratorios Homeopati cos, S.A. de C.V. AVENA SATIVA POLLEN; CINCHONA OFFICINALIS WHOLE; FERROSOFERRIC PHOSPHATE 8; 8; 8 [hp_X]/240g; [hp_X]/240g; [hp_X]/240g 34666-010_5bf3c700-94d3-4a9b-ab9d-f877423036f5 34666-010 HUMAN OTC DRUG Arnica Recovery Arnica Montana TABLET ORAL 20110701 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ARNICA MONTANA 6 [hp_C]/1 34666-011_d12b0e37-568f-4dfb-904e-6432efe8bac1 34666-011 HUMAN OTC DRUG Lari-Clear Baryta carbonica, Belladonna atropa, Phytolacca decandra PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV BARIUM CARBONATE; BELLADONNA LEAF; PHYTOLACCA AMERICANA ROOT 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-012_9e7890d2-0bd1-4dcf-9a14-efd83434e896 34666-012 HUMAN OTC DRUG APETYL Syrup Avena sativa 3X, China officinalis 3X and Hydrastis canadensis 3X SYRUP ORAL 20090730 UNAPPROVED HOMEOPATHIC Nartex Laboratorios Homeopati cos, S.A. de C.V. AVENA SATIVA POLLEN; CINCHONA OFFICINALIS WHOLE; HYDRASTIS CANADENSIS WHOLE 3; 3; 3 [hp_X]/240mL; [hp_X]/240mL; [hp_X]/240mL 34666-021_c504f50f-7331-487b-b284-4d2abdaf988c 34666-021 HUMAN OTC DRUG Appetyl Kids Cinchona pubescens, Hydrastis canadensis, Nux vomica PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV CINCHONA PUBESCENS BARK; GOLDENSEAL; STRYCHNOS NUX-VOMICA SEED 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-031_338ea921-98bf-43ee-8db7-9b0458972e0b 34666-031 HUMAN OTC DRUG K-Loss Fucus vesiculosus, Graphites, Phytolacca decandra PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV FUCUS VESICULOSUS; GRAPHITE; PHYTOLACCA AMERICANA ROOT 4; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-040_7a17e703-09b6-4597-be26-b9c3f6cc2097 34666-040 HUMAN OTC DRUG K-Loss Fucus vesiculosus, Graphites, Phytolacca decandra TABLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV FUCUS VESICULOSUS; GRAPHITE; PHYTOLACCA AMERICANA ROOT 4; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-050_2446aec6-f93a-4ca2-8e11-883c8c791d6c 34666-050 HUMAN OTC DRUG Menop-aid Cimicifuga, Lachesis trigonocephalus, Lilium tigrinum TABLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV BLACK COHOSH; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM BULB 6; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-060_8d7bd364-48c0-417a-acb9-3a65cbb95125 34666-060 HUMAN OTC DRUG Dismen-aid pms Chamomilla matricaria, Viburnum prunifolium, Viburnum opulus, Dioscorea Villosa TABLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV CHAMOMILE; DIOSCOREA VILLOSA ROOT; VIBURNUM OPULUS BARK; VIBURNUM PRUNIFOLIUM BARK 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-061_3a7bf06a-27bf-4f95-a909-b1756f097e22 34666-061 HUMAN OTC DRUG Menop-aid Cimicifuga, Lachesis trigonocephalus, Lilium tigrinum PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV BLACK COHOSH; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM BULB 6; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-071_600f9ce2-3a81-4147-afda-b5ba96add809 34666-071 HUMAN OTC DRUG Migraid Cyclamen europaeum, Gelsemium sempervirens, Iris versivolor, Spigelia anthelmia PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV CYCLAMEN PURPURASCENS TUBER; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; SPIGELIA ANTHELMIA 4; 4; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-081_8f696ba1-5f5f-4a80-8f28-261503e58441 34666-081 HUMAN OTC DRUG Gastrolean Magnesia carbonica, Natrum sulphuricum, Nux vomica, Robinia pseudoacacia PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV MAGNESIUM CARBONATE; ROBINIA PSEUDOACACIA BARK; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED 8; 4; 8; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-091_d7e56d64-d99e-46c0-a07a-f4c179185b6b 34666-091 HUMAN OTC DRUG Arnica Montana Arnica Montana PELLET ORAL 20110701 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ARNICA MONTANA 6 [hp_C]/1 34666-101_19bd8876-325b-4f99-b03d-241d5b6ddbe1 34666-101 HUMAN OTC DRUG Flu-less Aconitum napellus, Dulcamara, Gelsemium sempervirens PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ACONITUM NAPELLUS; GELSEMIUM SEMPERVIRENS ROOT; SOLANUM DULCAMARA FLOWER 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-111_2407e193-1d07-4146-a68e-d15ec83fef80 34666-111 HUMAN OTC DRUG Allerghin Dolichos pruriens, Rhus toxicodendron, Urtica urens PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV MUCUNA PRURIENS FRUIT TRICHOME; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-121_f844c322-0e2c-4918-8753-357e6eaee1a8 34666-121 HUMAN OTC DRUG Nartussal Bryonia alba, Drosera rotundifolia, Ipecacuanha PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; IPECAC 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-131_f25eae96-7742-4df8-9fac-cb9902cc5539 34666-131 HUMAN OTC DRUG Simplex Jr Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Matricaria chamomilla PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; HYOSCYAMUS NIGER; MATRICARIA CHAMOMILLA FLOWERING TOP OIL 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-141_88c703ce-53a8-4fed-9ac7-e680fa96898e 34666-141 HUMAN OTC DRUG Flu-less Aconitum napellus, Dulcamara, Gelsemium sempervirens TABLET ORAL 20120910 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ACONITUM NAPELLUS; GELSEMIUM SEMPERVIRENS ROOT; SOLANUM DULCAMARA FLOWER 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-151_afad6e98-5a10-4bdf-8033-71a959cce84d 34666-151 HUMAN OTC DRUG Nartussal Bryonia alba, Drosera rotundifolia, Ipecacuanha TABLET ORAL 20120910 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; IPECAC 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-161_ed3e6f1c-a01f-4dc0-bf27-5ebe7a6c32d1 34666-161 HUMAN OTC DRUG Lari-Clear Baryta carbonica, Belladonna atropa, Phytolacca decandra TABLET ORAL 20120910 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV BARIUM CARBONATE; BELLADONNA LEAF; PHYTOLACCA AMERICANA ROOT 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 34666-171_40f02f48-a567-4d01-a5d1-f39976083b55 34666-171 HUMAN OTC DRUG Nartussal Bryonia alba, Drosera rotundifolia, Ipecacuanha SYRUP ORAL 20120910 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; IPECAC 5; 5; 5 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL 34690-3001_58a168f3-48bd-450a-91eb-d65845b0a836 34690-3001 HUMAN OTC DRUG Slimming Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 1.27 g/4g 34690-3001_8c223786-e1e1-4883-88a0-2a51f53e5f55 34690-3001 HUMAN OTC DRUG Slimming Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 1.27 g/4g 34690-3001_ad71f559-10be-4f2f-9a60-0fccfb5fa10d 34690-3001 HUMAN OTC DRUG Slimming Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 1.27 g/4g 34690-3001_dc03bc2f-0ea0-4f39-b51e-c217b29b49c9 34690-3001 HUMAN OTC DRUG Slimming Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 1.27 g/4g 34690-4001_060cd292-0950-4179-891d-3df6a1d363a5 34690-4001 HUMAN OTC DRUG Eucalyptus Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.94 g/4g 34690-4001_1f0f7b19-70a3-4031-8ccc-9edd666a5cbf 34690-4001 HUMAN OTC DRUG Eucalyptus Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.94 g/4g 34690-4001_7c0e00ff-9322-4eab-a004-9fc71d913f75 34690-4001 HUMAN OTC DRUG Eucalyptus Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.94 g/4g 34690-4001_a90db06f-d9ac-4eb6-bd32-665839ba1490 34690-4001 HUMAN OTC DRUG Eucalyptus Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.94 g/4g 34690-5001_2fdf7f24-eaed-487d-9a8b-2d7ae9a50f15 34690-5001 HUMAN OTC DRUG Rose Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g 34690-5001_3fb1f393-be1b-409d-935c-7687f89802b4 34690-5001 HUMAN OTC DRUG Rose Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g 34690-5001_4d748aec-d0cf-4540-bf0f-83cc6cf4338d 34690-5001 HUMAN OTC DRUG Rose Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g 34690-5001_c9d23b3b-50a7-4482-b429-10b2da6c59bc 34690-5001 HUMAN OTC DRUG Rose Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g 34690-6001_0447d13d-3174-4633-be30-e564254e13fd 34690-6001 HUMAN OTC DRUG Lavender Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g 34690-6001_816b01f2-dba5-4df3-a9b2-41935375e5ec 34690-6001 HUMAN OTC DRUG Lavender Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g 34690-6001_834e5e5e-f6c2-4e59-bdf6-3c6c9ab443d8 34690-6001 HUMAN OTC DRUG Lavender Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g 34690-6001_c6c08fe0-23b4-4384-96d8-aafc3a10df5e 34690-6001 HUMAN OTC DRUG Lavender Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g 34690-7001_152e9ea5-5484-420e-a890-904a37e1227e 34690-7001 HUMAN OTC DRUG Forest Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g 34690-7001_4e0b3f20-560e-436c-8344-ae853e6e651d 34690-7001 HUMAN OTC DRUG Forest Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g 34690-7001_6b731407-817d-4894-ad57-13083ae068cc 34690-7001 HUMAN OTC DRUG Forest Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g 34690-7001_d0911fde-2a9c-4fe7-a9a5-6a36e932867c 34690-7001 HUMAN OTC DRUG Forest Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g 34690-8001_0e330704-00e7-4b56-8cc8-0091a79b6112 34690-8001 HUMAN OTC DRUG Warm Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.95 g/4g 34690-8001_9f558731-959d-45be-8ff3-5482008605c5 34690-8001 HUMAN OTC DRUG Warm Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.95 g/4g 34690-8001_a187b082-8a65-4d67-9952-ad31b14dc3df 34690-8001 HUMAN OTC DRUG Warm Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.95 g/4g 34690-8001_e6002281-0f9e-4576-8d46-72af2c6e52b4 34690-8001 HUMAN OTC DRUG Warm Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.95 g/4g 34690-9001_441c4f76-47b7-49e7-b57b-907318e2c77b 34690-9001 HUMAN OTC DRUG Bamboo Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g 34690-9001_4e284585-f896-4f97-a8d6-ca565bb87f4c 34690-9001 HUMAN OTC DRUG Bamboo Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g 34690-9001_6ddb7a76-b6ca-4ff8-8324-16efb7d84e89 34690-9001 HUMAN OTC DRUG Bamboo Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g 34690-9001_9949e78a-85fe-4f14-a258-2dd23eb4cc89 34690-9001 HUMAN OTC DRUG Bamboo Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g 34876-001_a8c16525-e350-46bc-83ba-31b6a2112a61 34876-001 HUMAN OTC DRUG Arthri-Zen Relief menthol CREAM TOPICAL 20070501 OTC MONOGRAPH NOT FINAL part348 RZN Nutraceuticals, Inc. MENTHOL 5 g/100g 34908-620_18c346ed-a0da-462c-8f2c-53b4ff08b693 34908-620 HUMAN PRESCRIPTION DRUG LEVONEST levonorgestrel and ethinyl estradiol KIT ORAL 20110331 ANDA ANDA090719 Novast Laboratories, Ltd. 34954-008_26eaab39-4dbd-44cb-a17f-1e53f82447f4 34954-008 HUMAN OTC DRUG ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL LIQUID TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 KIM CHEMICALS LTD. ISOPROPYL ALCOHOL 50 mL/100mL 34954-010_7528c0e0-a94b-11de-8a39-0800200c9a66 34954-010 HUMAN OTC DRUG ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333 KIM CHEMICALS LTD. ISOPROPYL ALCOHOL 50 mL/100mL 34954-013_038cb3b8-b145-46bf-9f30-4cf0d9028639 34954-013 HUMAN OTC DRUG Hot Ice Soothing Analgesic Gel Menthol GEL TOPICAL 20090921 OTC MONOGRAPH FINAL part341 Kim Chemicals LTD MENTHOL 2.27 g/227g 34954-014_f8a0f33f-e733-423e-bb1d-15489a31c542 34954-014 HUMAN OTC DRUG Vaporizing Chest Rub Menthol Camphor Eucalyptus Oil GEL TOPICAL 20090921 OTC MONOGRAPH FINAL part341 Kim Chemicals LTD CAMPHOR; EUCALYPTUS OIL; MENTHOL 4.7; 1.1; 1.1 g/110g; g/110g; g/110g 35000-002_a372ba69-1a2a-441f-a616-76ce75c3b697 35000-002 HUMAN OTC DRUG Colgate Total Whitening Silicon Dioxide, Sodium Fluoride, and Triclosan GEL, DENTIFRICE DENTAL 20100920 NDA NDA020231 Colgate-Palmolive Company SILICON DIOXIDE; SODIUM FLUORIDE; TRICLOSAN 50; 2.4; 3 mg/g; mg/g; mg/g 35000-003_805d43c1-8149-4202-ac7c-d42c18d9d5d2 35000-003 HUMAN OTC DRUG Colgate Total Whitening Silicon Dioxide, Sodium Fluoride, and Triclosan PASTE, DENTIFRICE DENTAL 20100810 NDA NDA020231 Colgate-Palmolive SILICON DIOXIDE; SODIUM FLUORIDE; TRICLOSAN 50; 2.4; 3 mg/g; mg/g; mg/g 35000-008_8626e0c4-4f77-4ad9-ab43-c8f281908a4e 35000-008 HUMAN OTC DRUG Colgate Sparkling White CinnaMint Fluoride Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120827 OTC MONOGRAPH FINAL part355 Colgate-Palmolive SODIUM FLUORIDE 2.4 mg/g 35000-021_2e47ac0a-685c-4637-8f19-6577126b7d49 35000-021 HUMAN OTC DRUG Colgate Total Clean Mint Silicon Dioxide, Sodium Fluoride, and Triclosan PASTE, DENTIFRICE DENTAL 20101130 NDA NDA020231 Colgate-Palmolive Company SILICON DIOXIDE; SODIUM FLUORIDE; TRICLOSAN 50; 2.4; 3 mg/g; mg/g; mg/g 35000-027_5abf894e-5d86-410a-98e1-84368200e7cb 35000-027 HUMAN OTC DRUG Colgate Total Zx Pro-Shield Plus Sensitive Sodium Monofluorophosphate, Zinc Citrate Trihydrate, and Potassium Nitrate PASTE, DENTIFRICE DENTAL 20130201 NDA NDA020231 Colgate-Palmolive POTASSIUM NITRATE; SODIUM MONOFLUOROPHOSPHATE; ZINC CITRATE TRIHYDRATE 2.4; .55; .96 mg/g; mg/g; mg/g 35000-046_ca8e5d3b-8839-40f6-a3cf-6ea5623a3fd2 35000-046 HUMAN OTC DRUG Colgate Sensitive multiprotection for Sensitive Teeth and Cavity Protection Sodium Fluoride and Potassium Nitrate PASTE, DENTIFRICE DENTAL 20121010 OTC MONOGRAPH FINAL part355 Colgate-Palmolive POTASSIUM NITRATE; SODIUM FLUORIDE 50; 2.4 mg/g; mg/g 35000-048_0e814ed4-428b-4f06-a27a-3d0196cb0eb6 35000-048 HUMAN OTC DRUG Colgate Total Gum Defense Silicon Dioxide, Sodium Fluoride, and Triclosan PASTE, DENTIFRICE DENTAL 20110625 NDA NDA020231 Colgate-Palmolive SILICON DIOXIDE; SODIUM FLUORIDE; TRICLOSAN 50; 2.4; 3 mg/g; mg/g; mg/g 35000-064_0cf44e36-a6db-4e4b-a593-aa7af0ddd52b 35000-064 HUMAN OTC DRUG Colgate UltraBrite Advanced Whitening Anticavity Fluoride Clean Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120823 OTC MONOGRAPH FINAL part355 Colgate-Palmolive SODIUM FLUORIDE 2.4 mg/g 35000-067_48b35e0c-3f05-4092-adf9-ddddd5583451 35000-067 HUMAN OTC DRUG Colgate Sensitive Whitening for Sensitive Teeth and Cavity Protection Sodium Fluoride and Potassium Nitrate PASTE, DENTIFRICE DENTAL 20121017 OTC MONOGRAPH FINAL part355 Colgate-Palmolive POTASSIUM NITRATE; SODIUM FLUORIDE 50; 2.4 mg/g; mg/g 35000-086_fe3a60bb-991e-47d7-bd19-40ef1406e011 35000-086 HUMAN OTC DRUG SoftSoap Antibacterial with moisturizers Crisp Clean Benzalkonium chloride LIQUID TOPICAL 20130119 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company BENZALKONIUM CHLORIDE 1.33 mg/mL 35000-087_cba6ec38-8181-4d75-8466-d522c34465f0 35000-087 HUMAN OTC DRUG SoftSoap Antibacterial with moisturizers Fresh Citrus Benzalkonium chloride LIQUID TOPICAL 20130119 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company BENZALKONIUM CHLORIDE 1.33 mg/mL 35000-114_4eab41ab-b493-4c46-a09d-699afab5f237 35000-114 HUMAN OTC DRUG Protex antibacterial Triclosan CREAM TOPICAL 20091209 OTC MONOGRAPH FINAL part333E Colgate Palmolive Company TRICLOSAN 1.5 mL/L 35000-120_09a2c99a-a2f9-49d9-a5b5-4f559dc1c16f 35000-120 HUMAN OTC DRUG Protex Deep Clean Triclocarban SOAP TOPICAL 20130603 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company TRICLOCARBAN 4 mg/g 35000-163_43a715fe-52c3-4b84-b1bc-29bd406890e0 35000-163 HUMAN OTC DRUG Colgate Tartar Protection Whitening Fluoride Cool Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120829 OTC MONOGRAPH FINAL part355 Colgate-Palmolive SODIUM FLUORIDE 2.4 mg/g 35000-364_8a23b915-b122-4e3e-9b34-6e156f3204ea 35000-364 HUMAN OTC DRUG Colgate Total Advance Whitening Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20080809 NDA NDA020231 Colgate-Palmolive SODIUM FLUORIDE; TRICLOSAN 2.4; 3 mg/g; mg/g 35000-570_7d421673-3c8f-4fd6-9aae-db663d21981a 35000-570 HUMAN OTC DRUG Colgate Total Advanced Fresh plus Whitening Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20110812 NDA NDA020231 Colgate-Palmolive SODIUM FLUORIDE; TRICLOSAN 1.5; 3 mg/g; mg/g 35000-581_317cac6b-a6ad-4134-9887-2ec01854654d 35000-581 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Power Powder Fresh Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20130203 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g 35000-582_5125b1fa-8d61-46aa-a3d2-e051f6c36407 35000-582 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Power Wild Freesia Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20130203 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g 35000-583_51cce963-f378-4a21-8902-f7121cd1544e 35000-583 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Power Spring Blossom Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20130203 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g 35000-585_6d151a30-12a0-4960-85bd-6d030f5d046b 35000-585 HUMAN OTC DRUG Lady Speed Stick Clinical Proof pH active Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20130123 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 200 mg/g 35000-586_10a56f61-65aa-4b60-afe5-0658b6f433e5 35000-586 HUMAN OTC DRUG Speed Stick Power Invigorate Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20130118 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-604_a2632043-3d88-42e3-8de6-32e8af8aaf48 35000-604 HUMAN OTC DRUG Softsoap Instant Hand Sanitizer with moisturizers Alcohol GEL TOPICAL 20130823 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company ALCOHOL 670 mL/1000mL 35000-608_f3f55e45-e049-46b2-a1af-d4fcbdb0fa1d 35000-608 HUMAN OTC DRUG Speed Stick Gametime Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20091209 OTC MONOGRAPH FINAL part350 Colgate Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-618_16eadb9d-1a5f-44c8-b240-79f41154e432 35000-618 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Aloe Soothing Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101210 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g 35000-622_d6802301-1bb8-42c9-8cc1-b3edea5a4614 35000-622 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101213 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g 35000-623_255b5845-0112-44dc-a8f4-07261ae4de9c 35000-623 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Shower Fresh Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101207 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g 35000-625_da169bb9-bfd0-4814-aa15-388172b1aea1 35000-625 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Wild Freesia Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110609 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g 35000-626_76102dfd-6066-4522-877d-049d03037f67 35000-626 HUMAN OTC DRUG SPEED STICK CRISP CUCUMBER Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101208 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g 35000-639_2528355b-a3b4-499b-9a14-120afd278ac2 35000-639 HUMAN OTC DRUG Speed Stick Teen Spirit Sweet Stawberry Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101208 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g 35000-643_d9fefd75-9781-4740-acdf-8bf17d2837df 35000-643 HUMAN OTC DRUG Lady Speed Stick Teen Spirit Berry Blossom Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20090615 OTC MONOGRAPH FINAL part350 Colgate Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 159 mg/g 35000-662_90a59398-ce2e-4969-87b4-1509b1a5df4e 35000-662 HUMAN OTC DRUG Speed Stick 24/7 Fresh Rush Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101210 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-664_c7795802-fd8d-4901-b087-b731b3abbacf 35000-664 HUMAN OTC DRUG Speed Stick Cool Fusion Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-670_66c2d19f-b46d-4ebc-bf66-eb59c57df7ee 35000-670 HUMAN OTC DRUG Speed Stick Unscented Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20110801 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-674_dcb84b7e-8696-4d77-8fd1-815e3e6982c9 35000-674 HUMAN OTC DRUG Speed Stick Sport Talc Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101207 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-675_4e57b908-187f-4eb3-98bf-d0c761b1c8ea 35000-675 HUMAN OTC DRUG Protex Balance antibacterial hand Benzalkonium chloride LIQUID TOPICAL 20130822 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company BENZALKONIUM CHLORIDE 1.33 mg/mL 35000-676_62bef3b0-382f-40fc-b026-d17a43fe2642 35000-676 HUMAN OTC DRUG Protex Oats antibacterial Benzalkonium chloride LIQUID TOPICAL 20130822 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company BENZALKONIUM CHLORIDE 1.33 mg/mL 35000-700_c72b92a6-3298-4de0-8ac4-585ae97cef48 35000-700 HUMAN OTC DRUG Speed Stick Irish Spring Icy Blast Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110609 OTC MONOGRAPH FINAL part350 Colgate Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-701_7bee99c3-c6aa-46d1-be15-92daffb262f1 35000-701 HUMAN OTC DRUG Speed Stick Irish Spring Original Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110609 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-702_7e20c0b7-3cf2-446b-9a50-7583ef1af3aa 35000-702 HUMAN OTC DRUG Irish Spring Legendary Classic Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110609 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-703_dba54bf7-c0d1-43b5-a9da-10385ec65271 35000-703 HUMAN OTC DRUG Lady Speed Stick Enchanted Cherry Blossom Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110609 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 159 mg/g 35000-704_5a675625-579d-4fa6-9af9-eabe84098e0a 35000-704 HUMAN OTC DRUG Lady Speed Stick Stainguard Silky Chiffon Scent Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 100 mg/g 35000-711_56e679f5-7bec-4ff2-89c6-67c25dc3ad22 35000-711 HUMAN OTC DRUG Lady Speed Stick Teen Spirit Pink Crush Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101210 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 159 mg/g 35000-711_c799bb59-d0cc-4b04-85b7-f330a90dddb7 35000-711 HUMAN OTC DRUG Lady Speed Stick Teen Spirit Pink Crush Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101210 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 159 mg/g 35000-714_c751c922-5cc1-4c1c-878a-35ef4ebebc00 35000-714 HUMAN OTC DRUG Lady Speed Stick Fresh Fusion Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101210 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g 35000-715_be746e28-04cf-432b-8e98-80eaa0979d8e 35000-715 HUMAN OTC DRUG Lady Speed Stick Satin Pear Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101208 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g 35000-716_be7fdf5b-5104-478c-80ce-142151f0f88d 35000-716 HUMAN OTC DRUG Lady Speed Stick 24x7 Powder Burst Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110609 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g 35000-800_c4c85798-ecd7-47b4-b234-861cc7668188 35000-800 HUMAN OTC DRUG Softsoap Antibacterial Triclosan LIQUID TOPICAL 20110901 OTC MONOGRAPH FINAL part333E Colgate-Palmolive Company TRICLOSAN 1.5 mg/mL 35000-810_7a8306b4-2092-4a37-8a89-442256b70d62 35000-810 HUMAN OTC DRUG SOFTSOAP ANTIBACTERIAL HAND Triclosan LIQUID TOPICAL 20101213 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company TRICLOSAN 1.15 mL/L 35000-810_cce592c0-5ada-446f-8644-b467bd957546 35000-810 HUMAN OTC DRUG SOFTSOAP ANTIBACTERIAL HAND Triclosan LIQUID TOPICAL 20101213 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company TRICLOSAN 1.15 mL/L 35000-818_21c2c600-52d8-4eb2-a2bc-619b3983a849 35000-818 HUMAN OTC DRUG Softsoap foaming hand sanitizer with light moisturizers Benzalkonium Chloride LIQUID TOPICAL 20100426 OTC MONOGRAPH NOT FINAL part333E Colgate Palmolive Company BENZALKONIUM CHLORIDE 1 mL/L 35000-834_bb79e78b-20bd-4d32-be20-cb0ffe8b082f 35000-834 HUMAN OTC DRUG Protex Oats Triclocarban LIQUID TOPICAL 20100211 OTC MONOGRAPH NOT FINAL part333E Colgate Palmolive Company TRICLOCARBAN 1.5 mL/L 35000-835_5b666c1c-94ba-4aee-b53f-a94d6258a5fd 35000-835 HUMAN OTC DRUG Protex Balance antibacterial liquid hand soap Triclosan LIQUID TOPICAL 20091209 OTC MONOGRAPH FINAL part333E Colgate Palmolive Company TRICLOSAN 1.5 mL/L 35000-842_45ab7a59-9efe-4fd3-9124-45ce696a5156 35000-842 HUMAN OTC DRUG Speed Stick Pro Extra Dry Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20090615 OTC MONOGRAPH FINAL part350 Colgate Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 172 mg/g 35000-844_63988843-e85e-4b0f-88a3-390449062b6e 35000-844 HUMAN OTC DRUG Ladies Speed Stick 24/7 Smooth Perfection Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101208 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 151 mg/g 35000-845_5c6e595e-c1c6-4759-a075-e25bd3e8b2b0 35000-845 HUMAN OTC DRUG Lady Speed Stick Stainguard Powder Fresh Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 100 mg/g 35000-846_b6fda337-fbf1-4fe4-bf2a-3427323fc389 35000-846 HUMAN OTC DRUG Lady Speed Stick Stainguard Daringly Fresh Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 100 mg/g 35000-847_3145ec8e-e81b-4121-8085-333a63371135 35000-847 HUMAN OTC DRUG Speed Stick Stainguard Clean Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 100 mg/g 35000-848_439fe99d-c711-47f0-b678-597769f1a0ed 35000-848 HUMAN OTC DRUG Speed Stick Stainguard Fresh Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20111012 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 100 mg/g 35000-850_b07df577-a326-49f8-b7da-63ed9e22f98f 35000-850 HUMAN OTC DRUG Protex BALANCE ANTIBACTERIAL HAND Triclocarban LIQUID TOPICAL 20110610 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company TRICLOCARBAN 1.5 mg/1000mL 35000-853_56936e51-bed5-4e76-88f7-cb366691ad67 35000-853 HUMAN OTC DRUG Softsoap Aquatic Splash Antibacterial with light Moisturizers Triclosan LIQUID TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company TRICLOSAN 1.5 mL/L 35000-854_7e62e65c-3f23-46c7-b16c-377cd3e31168 35000-854 HUMAN OTC DRUG Speed Stick Power Ultimate Sport Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110801 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g 35000-855_a077bf1b-165f-405a-b356-462218239277 35000-855 HUMAN OTC DRUG Lady Speed Stick 24/7 Fresh Fusion Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g 35000-856_20bbbde3-ca09-40d6-b09c-51e4ad7a1979 35000-856 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Shower Fresh Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g 35000-857_80766e01-6b0b-412c-bda4-6d603703e969 35000-857 HUMAN OTC DRUG Lady Speed Stick 24/7 Powder Burst Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g 35000-858_4d3aaf76-3190-4a26-af6e-b62fe40ab3ec 35000-858 HUMAN OTC DRUG Speed Stick 24/7 Gametime Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g 35000-859_e7b91348-46b6-4cba-a260-22e7ab7d815b 35000-859 HUMAN OTC DRUG Speed Stick 24/7 Cool Fusion Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g 35000-860_54975530-6ec2-48ff-9e04-9d6944417582 35000-860 HUMAN OTC DRUG Speed Stick 24/7 Fresh Rush Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g 35000-861_0e5da41d-accf-401f-b4fc-d26e8a1dc535 35000-861 HUMAN OTC DRUG Speed Stick Power Fresh Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110801 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g 35000-862_f2446750-086c-4f76-b711-2c5403085c1a 35000-862 HUMAN OTC DRUG Speed Stick Irish Spring Icy Blast Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-865_91481049-490a-4ecf-ac3a-b6d78da38c22 35000-865 HUMAN OTC DRUG Speed Stick Sport Talc Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-867_2fe04d82-0ffd-408f-ba0f-7a038cc80539 35000-867 HUMAN OTC DRUG Speed Stick Irish Spring Original Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-868_17cb6e02-77b7-4774-b9f5-8f21804769e0 35000-868 HUMAN OTC DRUG Lady Speed Stick Fresh Infusions Sparkling Lime Coconut Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20120117 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g 35000-869_789d40dd-b4c7-4516-8180-d3b94d1c16f5 35000-869 HUMAN OTC DRUG Speed Stick Power Energy Surge Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110801 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-870_578d8b7c-c60f-46d8-b632-ebfa8cbe7fd4 35000-870 HUMAN OTC DRUG Speed Stick Fresh Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111207 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-871_5f5890a0-2e35-4ed6-8474-8a902a24850d 35000-871 HUMAN OTC DRUG Speed Stick Power Fresh Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110801 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-872_da4c0016-3574-4e24-9404-36b7c28989d1 35000-872 HUMAN OTC DRUG Speed Stick Power Ultimate Sport Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20120626 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-873_f96759a2-4a1a-4457-92be-55a014e4bc68 35000-873 HUMAN OTC DRUG Irish Spring Body Wash Clear and Fresh Skin Salicylic acid LIQUID TOPICAL 20120626 OTC MONOGRAPH FINAL part333D Colgate-Palmolive Company SALICYLIC ACID 20 mL/L 35000-874_e615e190-e750-4e2d-ba11-163596c9e549 35000-874 HUMAN OTC DRUG Softsoap Aquatic Splash Antibacterial with light Moisturizers Benzalkonium chloride LIQUID TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part333E Colgate Palmolive Company BENZALKONIUM CHLORIDE 1.33 mg/mL 35000-875_2f9c5076-4edb-45ca-a714-3826bd64fd74 35000-875 HUMAN OTC DRUG SoftSoap Antiseptic Hand Wash Benzalkonium chloride LIQUID TOPICAL 20130808 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company BENZALKONIUM CHLORIDE 1.33 mg/mL 35000-876_4679a03a-92e5-4275-9f06-8c9414460457 35000-876 HUMAN OTC DRUG Speed Stick Gear Fresh Force Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-877_deaf9c5b-f182-4caf-92b8-a8fa5de8fa5b 35000-877 HUMAN OTC DRUG Speed Stick Gear Fresh Force Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g 35000-878_ac4e3020-9ef9-4b33-b331-164da6b890a9 35000-878 HUMAN OTC DRUG Speed Stick Gear Clean Peak Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35000-879_2d90573f-8bbe-490c-8238-88f90824f35b 35000-879 HUMAN OTC DRUG Speed Stick Gear Cool Motion Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g 35038-200_4c3957e1-7f64-468e-9f83-23e74802abab 35038-200 HUMAN OTC DRUG ASSURED ACNE CREAM ACNE CREAM CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part333D HANGZHOU MINO DAILY CHEMICALS CO.LTD. SALICYLIC ACID .5 mL/100mL 35192-002_9e27a24a-d6dc-4d76-af32-f80588ae7b53 35192-002 HUMAN OTC DRUG PAIN RELIEVER MENTHOL GEL TOPICAL 20110824 OTC MONOGRAPH NOT FINAL part348 CA-BOTANA INTERNATIONAL MENTHOL 2.4 g/120g 35192-006_5e651d2d-7b9b-4ef7-864d-a632b06fdd9e 35192-006 HUMAN OTC DRUG Shimmery Sun Octinoxate Titanium Dioxide LOTION TOPICAL 20120601 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 5.67; 4.53 g/113.4g; g/113.4g 35192-007_92ded6b4-4121-4045-8330-27fe8090dfbe 35192-007 HUMAN OTC DRUG UMBRELLA OCTINOXATE TITANIUM DIOXIDE LOTION TOPICAL 20130801 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 2.268; 2.268 g/56.7g; g/56.7g 35192-008_504333a6-c975-42e9-b6f8-90fcc2788f71 35192-008 HUMAN OTC DRUG Sunscreen SPF 40 LOTION TOPICAL 20120601 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 8.5; 6.8 g/113.4g; g/113.4g 35192-009_00031d79-af7f-4257-a385-c0b17e617cad 35192-009 HUMAN OTC DRUG Sun Essential Octinoxate Titanium Dioxide LOTION TOPICAL 20120601 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 17.75; 14.2 g/355g; g/355g 35192-009_9c7c3ae2-0f21-4e58-810f-8a661936f405 35192-009 HUMAN OTC DRUG Sun Essential Octinoxate Titanium Dioxide LOTION TOPICAL 20120601 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.2 g/30g; g/30g 35192-010_08ce9cc7-10e6-43ea-9bc9-dcb39ae45cb6 35192-010 HUMAN OTC DRUG Umbrella Sunscreen Octinoxate Titanium Dioxide LOTION TOPICAL 20120601 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 8.5; 6.8 g/113.4g; g/113.4g 35192-011_32b3e8c7-c4d3-4971-8f24-7b7f10361c4f 35192-011 HUMAN OTC DRUG ULTRA UMBRELLA OCTINOXATE TITANIUM DIOXIDE LOTION TOPICAL 20130801 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 4.536; 4.536 g/113.4g; g/113.4g 35192-012_0b1ed4f7-ea6a-4b24-af33-af38db9e4193 35192-012 HUMAN OTC DRUG Shimmery Sun Octinoxate Titanium Dioxide LOTION TOPICAL 20120601 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 4.536; 5.67 g/113.4g; g/113.4g 35192-013_22c78a5c-9ecd-405a-bc0e-6a06e55be275 35192-013 HUMAN OTC DRUG Umbrella Sunscreen Octinoxate Titanium Dioxide LOTION TOPICAL 20131010 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 3.75; 3 g/50g; g/50g 35192-014_7090373b-0b23-435f-8a24-1ea41c6dc144 35192-014 HUMAN OTC DRUG Shimmery Sun Octinoxate Titanium Dioxide LOTION TOPICAL 20131010 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 2; 2.5 g/113.4g; g/113.4g 35192-016_eca327ad-938c-44a4-9e1d-760a9bc833d2 35192-016 HUMAN OTC DRUG Controlling balm with tea tree oil SALICYLIC ACID EMULSION TOPICAL 20141109 OTC MONOGRAPH FINAL part358H CA-BOTANA INTERNATIONAL SALICYLIC ACID .24 mg/29.6mg 35192-017_e564883e-dd6b-41d8-991d-9ece810cb273 35192-017 HUMAN OTC DRUG Controlling Cream BENZOYL PEROXIDE CREAM TOPICAL 20141109 OTC MONOGRAPH FINAL part333D CA-BOTANA INTERNATIONAL BENZOYL PEROXIDE .8 mg/29.6mg 35192-018_264555f1-1f0e-4f6e-9b86-980676f6384a 35192-018 HUMAN OTC DRUG Controlling balm with tea tree oil SALICYLIC ACID EMULSION TOPICAL 20141109 OTC MONOGRAPH FINAL part358H CA-BOTANA INTERNATIONAL SALICYLIC ACID 1.89 mg/237mg 35356-004_96a0d964-326c-480c-996e-9af32ca3b352 35356-004 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride, naloxone hydrochloride TABLET SUBLINGUAL 20111110 NDA NDA020733 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 35356-007_e8d644dd-c343-4943-9aff-f933d1a7b11e 35356-007 HUMAN PRESCRIPTION DRUG DILAUDID HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 19560101 NDA NDA019892 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-011_0a49db2b-9cc4-4e51-bc56-00aaa2260de3 35356-011 HUMAN PRESCRIPTION DRUG Chantix varenicline tartrate TABLET, FILM COATED ORAL 20111228 NDA NDA021928 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC VARENICLINE TARTRATE .5 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] 35356-012_b4f81398-a298-4d96-b62c-4f9759850628 35356-012 HUMAN PRESCRIPTION DRUG Chantix varenicline tartrate TABLET, FILM COATED ORAL 20120223 NDA NDA021928 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC VARENICLINE TARTRATE 1 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] 35356-017_a3bdb68c-845d-4e23-a8e3-5684214df294 35356-017 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET ORAL 20101109 ANDA ANDA065405 Lake Erie Medical DBA Quality Care Products LLC AZITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 35356-028_c4bdc1b9-5ec2-410c-a4fb-bfdab9b969b0 35356-028 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20111122 ANDA ANDA077289 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-032_266fd4b9-3223-4465-8b38-6cc6d3f72726 35356-032 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20110219 ANDA ANDA076119 Lake Erie Medical DBA Quality Care Products LLC MIRTAZAPINE 45 mg/1 35356-033_d64f27e4-4f5e-40d1-b3aa-1101d95fc431 35356-033 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20111219 NDA AUTHORIZED GENERIC NDA019839 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-043_90cf6728-50da-48ae-a3c9-4b9b45170f92 35356-043 HUMAN PRESCRIPTION DRUG Zonalon doxepin hydrochloride CREAM TOPICAL 20120330 NDA NDA020126 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DOXEPIN HYDROCHLORIDE 50 mg/g Tricyclic Antidepressant [EPC] 35356-046_f0349923-d260-41e1-a96f-194ffcb2c4b7 35356-046 HUMAN PRESCRIPTION DRUG CELEXA citalopram hydrobromide TABLET, FILM COATED ORAL 20111117 NDA NDA020822 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-047_e69d7ca3-8e80-427a-a03a-2450ab04a564 35356-047 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120229 NDA NDA020616 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-048_e7d2e4aa-ec6b-43c6-a631-a6b050f38008 35356-048 HUMAN PRESCRIPTION DRUG KADIAN MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20111221 NDA NDA020616 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-049_e7d2e4aa-ec6b-43c6-a631-a6b050f38008 35356-049 HUMAN PRESCRIPTION DRUG KADIAN MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20111221 NDA NDA020616 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-050_e69d7ca3-8e80-427a-a03a-2450ab04a564 35356-050 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120229 NDA NDA020616 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-051_e69d7ca3-8e80-427a-a03a-2450ab04a564 35356-051 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120229 NDA NDA020616 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-052_e69d7ca3-8e80-427a-a03a-2450ab04a564 35356-052 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120229 NDA NDA020616 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-053_9c3cc965-5bbd-47bb-b082-8a0f1e658ea6 35356-053 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20110718 NDA NDA021724 Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC PREGABALIN 25 mg/1 CV 35356-053_deba1918-6f42-4df2-989f-fe782275b58a 35356-053 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20120319 NDA NDA021724 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PREGABALIN 25 mg/1 CV 35356-054_a1e4507e-6bc6-4225-bb66-db6069202261 35356-054 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20120206 NDA AUTHORIZED GENERIC NDA021724 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PREGABALIN 150 mg/1 35356-055_93f8d44d-b39c-443d-a3ab-d4cfa658ac42 35356-055 HUMAN PRESCRIPTION DRUG Ultram ER Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111227 NDA NDA021692 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 35356-056_93f8d44d-b39c-443d-a3ab-d4cfa658ac42 35356-056 HUMAN PRESCRIPTION DRUG Ultram ER Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111227 NDA NDA021692 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 35356-059_80b1a179-b9ea-4a7f-9006-e5a3fd63348d 35356-059 HUMAN PRESCRIPTION DRUG Amlodipine Besylate AMLODIPINE BESYLATE TABLET ORAL 20110221 ANDA ANDA078925 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 35356-059_9bcbe9e4-a541-4ee7-856d-1aacf7f7298f 35356-059 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20101104 ANDA ANDA078925 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 35356-062_c7274269-63db-46ba-a397-13064c625fb5 35356-062 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20130109 ANDA ANDA076258 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 12 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-063_8000a038-0046-4d1d-9962-4ff821cbb7f5 35356-063 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20110318 ANDA ANDA040789 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-064_e8375bd8-5a5c-4d31-90e4-c4906c6e7ee2 35356-064 HUMAN PRESCRIPTION DRUG Atripla efavirenz, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20060720 NDA NDA021937 Lake Erie Medical DBA Quality Care Products LLC EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600; 200; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 35356-076_e69d7ca3-8e80-427a-a03a-2450ab04a564 35356-076 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120229 NDA NDA020616 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-077_27fab972-7b99-46da-b13e-d08bd70fd180 35356-077 HUMAN PRESCRIPTION DRUG FLECTOR DICLOFENAC EPOLAMINE PATCH TOPICAL 20111111 NDA NDA021234 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DICLOFENAC EPOLAMINE 180 mg/14g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-085_77b8c0cd-1512-4609-9783-4429e15505f3 35356-085 HUMAN OTC DRUG Cetirizine Hydrochloride cetirizine hydrochloride TABLET, FILM COATED ORAL 20120223 ANDA ANDA076677 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 35356-086_d069cb90-6564-4a4f-a7c8-e77bf4e880e3 35356-086 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20120416 NDA NDA020639 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 35356-087_5df04264-7bf6-48ac-b2bc-b8006bdce0e2 35356-087 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100714 ANDA ANDA079095 Lake Erie Medical DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 35356-090_4c5f4a7e-73e7-411a-901c-9179dfe35da9 35356-090 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110609 NDA NDA020553 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-091_4c5f4a7e-73e7-411a-901c-9179dfe35da9 35356-091 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110609 NDA NDA020553 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-092_b44c52e7-5866-4237-a8b0-711c83132165 35356-092 HUMAN PRESCRIPTION DRUG Rozerem Rozerem TABLET, FILM COATED ORAL 20110518 NDA NDA021782 Lake Erie Medical DBA Quality Care Products LLC RAMELTEON 8 mg/1 Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA] 35356-097_d5f032fb-3dce-4132-a117-8e6439b91808 35356-097 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 35356-101_0cb90d70-7863-4a4f-b21a-8406a51dcbd7 35356-101 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20120228 NDA NDA021283 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 35356-103_cfa2e40c-5231-40f2-8099-8c3c4decac39 35356-103 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20120309 NDA NDA021995 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SITAGLIPTIN PHOSPHATE 100 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 35356-104_a4e8c3b3-15a4-49ad-9420-29eafbb1a630 35356-104 HUMAN PRESCRIPTION DRUG LOVAZA omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20081021 NDA NDA021654 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OMEGA-3-ACID ETHYL ESTERS 1 g/1 35356-118_c0d14587-f4b3-4786-bb37-b5faebcf1a27 35356-118 HUMAN PRESCRIPTION DRUG AVINZA morphine sulfate CAPSULE, COATED, EXTENDED RELEASE ORAL 20111025 NDA NDA021260 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-125_05123f92-a855-489b-a361-882f7e6b01c6 35356-125 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20110718 ANDA ANDA076341 Lake Erie Medical DBA Quality Care Products LLC PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 35356-126_2cac4a53-64b2-45f5-a591-88c8cd792c12 35356-126 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19900930 ANDA ANDA089808 Lake Erie Medical DBA Quality Care Products LLC THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 35356-131_a32bb760-1bec-47a4-9a09-19cf73521128 35356-131 HUMAN PRESCRIPTION DRUG AVAPRO IRBESARTAN TABLET ORAL 20120323 NDA NDA020757 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 35356-136_a518e35b-f24b-4435-ac41-251318b915ad 35356-136 HUMAN PRESCRIPTION DRUG JANUMET sitagliptin and metformin hydrochloride TABLET, FILM COATED ORAL 20120309 NDA NDA022044 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 500; 50 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 35356-141_dfb614d7-647d-4682-a41b-13d5a8076fcd 35356-141 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine CAPSULE ORAL 20100713 NDA NDA021411 Lake Erie Medical DBA Quality Care Products LLC ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 35356-143_9f869872-96ef-4f56-842b-2610f24d1335 35356-143 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20120214 ANDA ANDA077634 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 35356-162_a501cd2e-281c-4b88-85c8-3e636f96ac37 35356-162 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 20120229 NDA NDA020241 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 35356-166_298c05d9-277f-428f-b502-fa44fdb67923 35356-166 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 35356-169_a8925797-7a88-4a2d-a1fc-4078c4494376 35356-169 HUMAN PRESCRIPTION DRUG Frova Frovatriptan succinate TABLET, FILM COATED ORAL 20100818 NDA NDA021006 Lake Erie Medical DBA Quality Care Products LLC FROVATRIPTAN SUCCINATE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 35356-171_edcdf965-3b14-43a4-aa6b-6561cd1064dc 35356-171 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20120217 NDA NDA021436 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] 35356-172_a501cd2e-281c-4b88-85c8-3e636f96ac37 35356-172 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 20120229 NDA NDA020241 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 35356-173_a501cd2e-281c-4b88-85c8-3e636f96ac37 35356-173 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 20120229 NDA NDA020241 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 35356-174_b4f81398-a298-4d96-b62c-4f9759850628 35356-174 HUMAN PRESCRIPTION DRUG Chantix varenicline tartrate TABLET, FILM COATED ORAL 20120223 NDA NDA021928 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC VARENICLINE TARTRATE 1 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] 35356-175_b4f81398-a298-4d96-b62c-4f9759850628 35356-175 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate KIT 20060510 NDA NDA021928 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-176_5615b049-fca5-4b33-8069-e3ae3a902d54 35356-176 HUMAN PRESCRIPTION DRUG Pentazocine and naloxone Pentazocine hydrochloride and naloxone hydrochloride TABLET ORAL 19970121 ANDA ANDA074736 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE .5; 50 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIV 35356-187_ddefea5b-ef91-458a-89d2-8348e43fbbf5 35356-187 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20111111 NDA NDA022122 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-197_a68bdb87-db46-4f14-b60c-c0097a02b519 35356-197 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20101110 ANDA ANDA077557 Lake Erie Medical DBA Quality Care Products LLC ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 35356-203_a501cd2e-281c-4b88-85c8-3e636f96ac37 35356-203 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 20120229 NDA NDA020241 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 35356-204_cee33acd-3feb-4ed0-a832-cb927421b6d2 35356-204 HUMAN PRESCRIPTION DRUG Seroquel QUETIAPINE FUMARATE TABLET, FILM COATED ORAL 20100707 NDA NDA020639 Lake Erie Medical DBA Quality Care Products LLC QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 35356-210_2caf50e1-2ad5-415d-b35d-2de4c9fe9730 35356-210 HUMAN PRESCRIPTION DRUG AVODART dutasteride CAPSULE, LIQUID FILLED ORAL 20120326 NDA NDA021319 Lake Erie Medical & Surgcial Supply DBA Quality Care Products LLC DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 35356-211_a3a4f2a2-0445-4c5c-8c1b-f8b6cc39ebdb 35356-211 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET ORAL 20120214 ANDA ANDA077290 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-212_455b6474-99cb-424c-be4e-5496344a8a0c 35356-212 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20111220 ANDA ANDA077290 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-215_c81cd0b3-ac3f-4f63-8811-f8ebe54aeed4 35356-215 HUMAN PRESCRIPTION DRUG Spiriva tiotropium bromide CAPSULE ORAL; RESPIRATORY (INHALATION) 20051011 NDA NDA021395 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TIOTROPIUM BROMIDE MONOHYDRATE 18 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 35356-216_f5e15368-bbe1-4515-abf1-96e2469b9bb1 35356-216 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20120222 NDA NDA021286 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 35356-226_47caf417-a6a8-43bb-8cbf-c12ffb94319a 35356-226 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 20110712 ANDA ANDA074461 Lake Erie Medical DBA Quality Care Products LLC INDAPAMIDE 1.25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 35356-243_e66e8228-fd32-49cc-96e7-9d8b12db0046 35356-243 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20100916 ANDA ANDA077919 Lake Erie Medical DBA Quality Care Products LLC TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 35356-249_27826e20-9444-4204-977e-e8f7857c1351 35356-249 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20120322 NDA NDA004782 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ESTROGENS, CONJUGATED .3 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 35356-250_27826e20-9444-4204-977e-e8f7857c1351 35356-250 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20120322 NDA NDA004782 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ESTROGENS, CONJUGATED .9 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 35356-251_27826e20-9444-4204-977e-e8f7857c1351 35356-251 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20120322 NDA NDA004782 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ESTROGENS, CONJUGATED .45 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 35356-252_e58ac062-27a8-48a2-82f8-ec6152ebd4e1 35356-252 HUMAN PRESCRIPTION DRUG MAXALT rizatriptan benzoate TABLET ORAL 20070824 NDA NDA020864 Lake Erie Medical DBA Quality Care Products LLC RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 35356-253_068d6109-a406-44c8-baab-56959293467f 35356-253 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate TABLET, FILM COATED ORAL 20120328 NDA NDA020132 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 35356-254_068d6109-a406-44c8-baab-56959293467f 35356-254 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate TABLET, FILM COATED ORAL 20120328 NDA NDA020132 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 35356-256_ba2ac39e-4bd4-443d-80e7-b928561905ed 35356-256 HUMAN PRESCRIPTION DRUG Benicar Hct olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20120222 NDA NDA021532 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5; 20 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 35356-257_ba2ac39e-4bd4-443d-80e7-b928561905ed 35356-257 HUMAN PRESCRIPTION DRUG Benicar Hct olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20120222 NDA NDA021532 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 35356-258_ba2ac39e-4bd4-443d-80e7-b928561905ed 35356-258 HUMAN PRESCRIPTION DRUG Benicar Hct olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20120222 NDA NDA021532 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 35356-262_e0a5ea68-41e6-44cd-9ea6-1810f4a82ae5 35356-262 HUMAN PRESCRIPTION DRUG Amrix Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120103 NDA NDA021777 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 35356-263_a1e28f7e-0546-49b7-9a09-e708754e8783 35356-263 HUMAN PRESCRIPTION DRUG AMRIX Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071001 NDA NDA021777 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 30 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 35356-272_85782ed3-ab22-4a6b-94f9-3bbb2f3ce4d2 35356-272 HUMAN PRESCRIPTION DRUG Enablex darifenacin TABLET, EXTENDED RELEASE ORAL 20120305 NDA NDA021513 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DARIFENACIN 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 35356-293_a996260c-cb36-45bf-8f2c-d8a621951aea 35356-293 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120228 NDA NDA020818 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 35356-294_a996260c-cb36-45bf-8f2c-d8a621951aea 35356-294 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20060428 NDA NDA020818 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 35356-298_d9f534ec-6d03-4797-ac8e-2f70f6edf8ed 35356-298 HUMAN PRESCRIPTION DRUG Micardis TELMISARTAN TABLET ORAL 20120315 NDA NDA020850 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 35356-299_4891ca38-d307-4c0b-8a20-f13e069b8f96 35356-299 HUMAN PRESCRIPTION DRUG Micardis HCT TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET ORAL 20120315 NDA NDA021162 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 35356-300_4891ca38-d307-4c0b-8a20-f13e069b8f96 35356-300 HUMAN PRESCRIPTION DRUG Micardis HCT TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET ORAL 20120315 NDA NDA021162 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; TELMISARTAN 25; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 35356-301_05ecb8cf-85d3-4a4e-8c3e-99031e70c6ca 35356-301 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120403 NDA NDA020381 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 35356-302_05ecb8cf-85d3-4a4e-8c3e-99031e70c6ca 35356-302 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120403 NDA NDA020381 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 35356-303_ebd6ebfb-bfc5-40be-a2a4-5e169d8bca02 35356-303 HUMAN PRESCRIPTION DRUG Prandin Repaglinide TABLET ORAL 20101012 NDA NDA020741 Lake Erie Medical DBA Quality Care Products LLC REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 35356-317_3678805c-0cff-4b6d-9d1a-0aaee7718b74 35356-317 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20120712 NDA NDA020592 Lake Erie Medical DBA Quality Care Products LLC OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 35356-324_f0c467f6-bd22-4c7a-b66b-4634169e389c 35356-324 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, EXTENDED RELEASE ORAL 20120306 ANDA ANDA076174 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-325_f8200669-8573-4684-8224-d5cccb5cc33b 35356-325 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 20111206 ANDA ANDA040120 Lake Erie Medical & Surgical Supply DBA Quality Care Prodcuts LLC PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 35356-333_c0d14587-f4b3-4786-bb37-b5faebcf1a27 35356-333 HUMAN PRESCRIPTION DRUG AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111025 NDA NDA021260 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 90 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-335_ea71109f-ec1b-42bd-af8f-8e0684266676 35356-335 HUMAN PRESCRIPTION DRUG MS Contin morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110131 NDA NDA019516 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-339_c0d14587-f4b3-4786-bb37-b5faebcf1a27 35356-339 HUMAN PRESCRIPTION DRUG AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111025 NDA NDA021260 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 120 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-341_997193e1-d59a-474c-a574-a4e3dd3db2db 35356-341 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride CAPSULE ORAL 20120328 NDA NDA021447 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 35356-342_997193e1-d59a-474c-a574-a4e3dd3db2db 35356-342 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride CAPSULE ORAL 20120328 NDA NDA021447 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 35356-355_41eee657-dbd9-47fa-bab4-35f0e79f8ec4 35356-355 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET ORAL 20081028 ANDA ANDA078536 Lake Erie Medical DBA Quality Care Products LLC CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 35356-360_e98070f9-45ed-45c5-9537-d31656fa95b0 35356-360 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Lake Erie Medical DBA Quality Care Products LLC GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 35356-362_958d307a-e348-4f8d-b83e-b554e892cfa8 35356-362 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Lake Erie Medical DBA Quality Care Products LLC LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 35356-372_a1b9e82a-4389-44b9-ab7b-49c540ff1732 35356-372 HUMAN PRESCRIPTION DRUG PROVIGIL modafinil TABLET ORAL 20110720 NDA NDA020717 Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 35356-375_563e774e-b56b-4022-9413-3f7ad3497e23 35356-375 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-380_404fbf7a-3245-446b-88bf-8e425456c5dc 35356-380 HUMAN PRESCRIPTION DRUG OPANA Oxymorphone Hydrochloride TABLET ORAL 20120209 NDA NDA021611 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-386_eb85a029-950f-47f2-934a-391ced60add4 35356-386 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 Lake Erie Medical DBA Quality Care Products LLC DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 35356-387_66ba49b4-bccc-45e1-8a2f-16ca204e17e6 35356-387 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate TABLET ORAL 20111207 ANDA ANDA040361 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 35356-388_31622e6a-8789-42bf-b0d8-17879e948b8d 35356-388 HUMAN PRESCRIPTION DRUG OPANA ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111110 NDA NDA021610 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-389_31622e6a-8789-42bf-b0d8-17879e948b8d 35356-389 HUMAN PRESCRIPTION DRUG OPANA ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111110 NDA NDA021610 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-391_8365d1b4-3305-45aa-a96b-db26dd5ce1ee 35356-391 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120214 NDA NDA201655 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-392_34936475-5f12-4560-9d30-73912e692d43 35356-392 HUMAN PRESCRIPTION DRUG Mirapex Pramipexole Dihydrochloride TABLET ORAL 20101005 NDA NDA020667 Lake Erie Medical DBA Quality Care Products LLC PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 35356-397_2f437238-c8f0-4c31-b74a-74f5a558649d 35356-397 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Lake Erie Medical DBA Quality Care Products LLC WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 35356-398_dc2675ec-e5f2-4ee7-baaf-e5a6859a182d 35356-398 HUMAN PRESCRIPTION DRUG Lyrica Pregabalin CAPSULE ORAL 20100813 NDA NDA021724 Lake Erie Medical DBA Quality Care Products LLC PREGABALIN 300 mg/1 CV 35356-403_8365d1b4-3305-45aa-a96b-db26dd5ce1ee 35356-403 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120214 NDA NDA201655 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-413_a6cdb652-f16b-4266-92a8-d5b352b0b22f 35356-413 HUMAN PRESCRIPTION DRUG Crestor Rosuvastatin calcium TABLET, COATED ORAL 20100908 NDA NDA021366 Lake Erie Medical DBA Quality Care Products LLC ROSUVASTATIN CALCIUM 40 mg/1 35356-417_18300da0-4a5a-4990-9a04-200f2c8db73b 35356-417 HUMAN PRESCRIPTION DRUG Detrol LA tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20120228 NDA NDA021228 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 35356-419_6ca39a60-a09c-4d77-867c-47a4620e344f 35356-419 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20110415 ANDA ANDA040750 Lake Erie Medical DBA Quality Care Products LLC SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 35356-426_27826e20-9444-4204-977e-e8f7857c1351 35356-426 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20120322 NDA NDA004782 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ESTROGENS, CONJUGATED 1.25 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 35356-428_a32bb760-1bec-47a4-9a09-19cf73521128 35356-428 HUMAN PRESCRIPTION DRUG AVAPRO IRBESARTAN TABLET ORAL 20120323 NDA NDA020757 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 35356-429_2c8f346f-60b4-4fb4-b8d6-fa1272188d63 35356-429 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120123 ANDA ANDA078154 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 35356-432_ecff66ee-c7a1-438a-a455-0a076936a11a 35356-432 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Lake Erie Medical DBA Quality Care Products LLC BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 35356-438_99eb293b-7024-4480-a2e1-c4f4cc3ff67c 35356-438 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Lake Erie Medical DBA Quality Care Products LLC SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 35356-439_99eb293b-7024-4480-a2e1-c4f4cc3ff67c 35356-439 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Lake Erie Medical DBA Quality Care Products LLC SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 35356-444_4c5f4a7e-73e7-411a-901c-9179dfe35da9 35356-444 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110609 NDA NDA020553 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-445_6ca04926-5847-4179-82ae-93c34db7d756 35356-445 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20111103 ANDA ANDA076252 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 35356-446_997193e1-d59a-474c-a574-a4e3dd3db2db 35356-446 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride CAPSULE ORAL 20120328 NDA NDA021447 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 35356-448_f66ee285-f07a-43e2-8e79-d2a2a66aac51 35356-448 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20120309 ANDA ANDA078525 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 35356-462_c18183b9-bbd6-436d-b740-607f79010761 35356-462 HUMAN PRESCRIPTION DRUG Xyzal Levocetirizine dihydrochloride TABLET, FILM COATED ORAL 20100810 NDA NDA022064 Lake Erie Medical DBA Quality Care Products LLC LEVOCARNITINE HYDROCHLORIDE 5 mg/1 Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] 35356-469_aa10bd60-5ceb-4545-81f9-3dee98d44c1d 35356-469 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20111129 ANDA ANDA090278 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 35356-470_c1eb3537-15cd-4f5e-a788-00b90db89054 35356-470 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20111129 ANDA ANDA090278 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 35356-471_ed5ffc9b-3ed8-49bc-9560-461b6cd3e9d0 35356-471 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20101028 ANDA ANDA090278 Lake Erie Medical DBA Quality Care Products LLC TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 35356-472_5cdbe9cf-66f8-4f3d-a0c6-928029e8240b 35356-472 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Lake Erie Medical DBA Quality Care Products LLC TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 35356-473_1c53e450-9c25-4e7b-912b-58989a059e64 35356-473 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE ORAL 20100713 ANDA ANDA076570 Lake Erie Medical DBA Quality Care Products LLC TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 35356-474_761dd748-ecee-47f3-907b-c6e9de4c421e 35356-474 HUMAN PRESCRIPTION DRUG VERAMYST fluticasone furoate SPRAY, METERED NASAL 20070515 NDA NDA022051 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLUTICASONE FUROATE 27.5 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 35356-477_2706ff2a-0dc7-48e3-af41-e6c322278923 35356-477 HUMAN PRESCRIPTION DRUG PATADAY olopatadine hydrochloride SOLUTION/ DROPS OPHTHALMIC 20120403 NDA NDA021545 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OLOPATADINE HYDROCHLORIDE 2 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 35356-491_e741d2cb-7ec7-4b8c-9f5c-5e2b367a9b87 35356-491 HUMAN PRESCRIPTION DRUG Pristiq Extended-Release desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20120416 NDA NDA021992 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 35356-498_c759a7ba-6732-4d81-a038-cd83aceb239b 35356-498 HUMAN PRESCRIPTION DRUG RYZOLT TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20120322 NDA NDA021745 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 35356-499_404fbf7a-3245-446b-88bf-8e425456c5dc 35356-499 HUMAN PRESCRIPTION DRUG OPANA Oxymorphone Hydrochloride TABLET ORAL 20120209 NDA NDA021611 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-500_41edd35f-8fe5-48d6-82c8-c4fe460a73b4 35356-500 HUMAN PRESCRIPTION DRUG Amitiza lubiprostone CAPSULE, GELATIN COATED ORAL 20110601 NDA NDA021908 Lake Erie Medical DBA Quality Care Products LLC LUBIPROSTONE 24 ug/1 Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] 35356-501_31b420ab-d475-47bd-8c3b-a7493dbb784a 35356-501 HUMAN PRESCRIPTION DRUG Soma Carisoprodol TABLET ORAL 20070901 NDA NDA011792 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CARISOPRODOL 250 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 35356-503_42eab319-7c06-4bc0-a7c0-521ab6399b12 35356-503 HUMAN PRESCRIPTION DRUG Alprazolam XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA AUTHORIZED GENERIC NDA021434 Lake Erie Medical DBA Quality Care Products LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 35356-504_feb55638-e17e-427b-b7ef-9f0248659f70 35356-504 HUMAN PRESCRIPTION DRUG Alprazolam XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA AUTHORIZED GENERIC NDA021434 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 35356-512_c8042b87-63ab-47d1-8359-9af500033b4d 35356-512 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Lake Erie Medical DBA Quality Care Products LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 35356-513_158366bb-c688-4ad2-8600-8bb8c31dc2ea 35356-513 HUMAN PRESCRIPTION DRUG carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077346 Lake Erie Medical DBA Quality Care Products LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 35356-514_63efdd0b-5d3f-46c0-bb0b-a49c572e168b 35356-514 HUMAN PRESCRIPTION DRUG Dilaudid hydromorphone hydrochloride TABLET ORAL 20111201 NDA NDA019892 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-515_1328a5ca-1328-4461-86e6-e775d5f4f20b 35356-515 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20071001 NDA NDA021210 Lake Erie Medical DBA Quality Care Products LLC LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 35356-521_4999f6bf-af7e-4c8f-ae91-48a2931be1dd 35356-521 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE EXTENDED-RELEASE MORPHINE SULFATE TABLET ORAL 20110728 ANDA ANDA076438 Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-525_c3f61b6e-afc3-4b69-9302-be403d23cb0e 35356-525 HUMAN PRESCRIPTION DRUG Nucynta Tapentadol TABLET ORAL 20100929 NDA NDA022304 Lake Erie Medical DBA Quality Care Products LLC TAPENTADOL 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 35356-526_c8042b87-63ab-47d1-8359-9af500033b4d 35356-526 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Lake Erie Medical DBA Quality Care Products LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 35356-528_f3671457-c278-435c-ba53-e8fad743b41a 35356-528 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE EXTENDED-RELEASE MORPHINE SULFATE TABLET ORAL 20120320 ANDA ANDA076438 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-530_7da2bfe8-bc4a-43bd-8613-6947c0f2ab2c 35356-530 HUMAN PRESCRIPTION DRUG NAPRELAN naproxen sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111129 NDA NDA020353 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NAPROXEN SODIUM 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-533_2c8f346f-60b4-4fb4-b8d6-fa1272188d63 35356-533 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120123 ANDA ANDA078154 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 35356-537_f75a3abe-01e9-47d8-a96e-5c4958203ae0 35356-537 HUMAN PRESCRIPTION DRUG Zipsor diclofenac potassium CAPSULE, LIQUID FILLED ORAL 20101222 NDA NDA022202 Lake Erie Medical DBA Quality Care Products DICLOFENAC POTASSIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-541_117b4f2b-98e3-490e-8c1f-21a45a8675bf 35356-541 HUMAN PRESCRIPTION DRUG Enalapril Maleate enalapril maleate TABLET ORAL 20000822 ANDA ANDA075480 Lake Erie Medical DBA Quality Care Products LLC ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 35356-542_8136ad04-d031-49f6-8f6b-0868f007ab84 35356-542 HUMAN OTC DRUG Terocin Methyl Salicylate, Capsaicin, Menthol and Lidocaine Hydrochloride LOTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part348 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE .025; 2.5; 10; 25 g/100mL; g/100mL; g/100mL; g/100mL 35356-544_2f46bb32-6f89-4fe4-a7da-4be6ba9c0fb2 35356-544 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20060906 ANDA ANDA077706 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC POLYETHYLENE GLYCOL 3350 17 g/17g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 35356-545_d2db70ba-7798-4ef3-925c-e56e747ff86c 35356-545 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20111117 NDA NDA022256 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MILNACIPRAN HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-546_dfd77da2-6f3c-44f3-b70d-94189aa729ff 35356-546 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078783 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 35356-547_dfd77da2-6f3c-44f3-b70d-94189aa729ff 35356-547 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078783 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 35356-561_03cc7a67-fbb3-4205-82aa-5bc174bf7a8c 35356-561 HUMAN PRESCRIPTION DRUG Oxycodone hydrochloride and Ibuprofen Oxycodone hydrochloride and Ibuprofen TABLET, FILM COATED ORAL 20081104 ANDA ANDA078769 Lake Erie Medical DBA Quality Care Products LLC IBUPROFEN; OXYCODONE HYDROCHLORIDE 400; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 35356-567_743cc713-fe6a-4627-bb93-115ed3abedf9 35356-567 HUMAN PRESCRIPTION DRUG Pristiq Extended Release desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20110126 NDA NDA021992 Lake Erie Medical DBA Quality Care Products LLC DESVENLAFAXINE SUCCINATE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 35356-568_eef4f1c7-bf99-49b9-9807-311af330c10f 35356-568 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20111205 NDA NDA021436 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] 35356-569_c43cb183-d3d2-48e1-b18a-200b8fa953bb 35356-569 HUMAN PRESCRIPTION DRUG TRANZGEL ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM GEL TRANSDERMAL 20111111 UNAPPROVED HOMEOPATHIC Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL 1; 3; 3; 3; 1; 1; 1; 3; 4; 1; 1; 1; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 35356-570_f5b13d71-cb1f-470d-b0b9-36f0b711e566 35356-570 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20111206 NDA NDA013217 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 35356-571_2f437238-c8f0-4c31-b74a-74f5a558649d 35356-571 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Lake Erie Medical DBA Quality Care Products LLC WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 35356-573_9fc3163c-a307-48b9-9add-5c195dc24ecc 35356-573 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20111205 NDA NDA020859 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 35356-579_530976bb-8f1f-4354-b74d-d749a6dc038c 35356-579 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111206 ANDA ANDA091272 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-580_5bc5e226-3241-425d-b063-e72c8a3bc75c 35356-580 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-582_2f437238-c8f0-4c31-b74a-74f5a558649d 35356-582 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Lake Erie Medical DBA Quality Care Products LLC WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 35356-586_820e579d-2cb3-4fb5-9988-cdf90b4b10dc 35356-586 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 Lake Erie Medical DBA Quality Care Products LLC Care Producst HYDROCODONE BITARTRATE; IBUPROFEN 5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 35356-589_5270f354-e5f6-4e9b-824b-e3b4f92178a1 35356-589 HUMAN PRESCRIPTION DRUG Nuvigil armodafinil TABLET ORAL 20090601 NDA NDA021875 Lake Erie Medical DBA Quality Care Products LLC ARMODAFINIL 150 mg/1 CIV 35356-590_3406f8c9-f2e8-4076-9016-15ed06f3b3dd 35356-590 HUMAN PRESCRIPTION DRUG PENNSAID diclofenac sodium LIQUID TOPICAL 20100405 NDA NDA020947 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-592_2163f4b2-e6c4-4f63-b5df-8f41832fcd0e 35356-592 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19831021 ANDA ANDA088276 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 35356-593_3ac821f0-cb18-4f79-873d-e199d68ce317 35356-593 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20110713 NDA NDA022304 Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC TAPENTADOL HYDROCHLORIDE 75 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 35356-603_8b88104b-1fba-4a7b-8a46-34d4e056642e 35356-603 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20110113 ANDA ANDA076520 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 35356-604_6d2b3daa-6b68-4dcf-a566-7109474d2e3b 35356-604 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Lake Erie Medical DBA Quality Care Products LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 35356-605_5fe0b1ac-b81d-4e06-a0f7-8702fdb619f0 35356-605 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20120326 NDA NDA021306 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BUPRENORPHINE 10 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 35356-606_5fe0b1ac-b81d-4e06-a0f7-8702fdb619f0 35356-606 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20120326 NDA NDA021306 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BUPRENORPHINE 20 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 35356-607_5fe0b1ac-b81d-4e06-a0f7-8702fdb619f0 35356-607 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20120326 NDA NDA021306 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BUPRENORPHINE 5 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 35356-608_6957a248-d0e0-478a-81cc-6a615f0ab9a1 35356-608 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110314 NDA NDA021217 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 12 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-609_6957a248-d0e0-478a-81cc-6a615f0ab9a1 35356-609 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110314 NDA NDA021217 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 16 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-610_6957a248-d0e0-478a-81cc-6a615f0ab9a1 35356-610 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110314 NDA NDA021217 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-611_9156f5bf-be5f-4cd8-8a4c-bc8c204e666c 35356-611 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20090601 NDA NDA022304 Lake Erie Medical DBA Quality Care Products LLC TAPENTADOL HYDROCHLORIDE 100 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 35356-613_bad0d374-922a-4bc0-8fb0-96b895cae7cb 35356-613 HUMAN PRESCRIPTION DRUG Divalproex Sodium DR Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20091014 ANDA ANDA078790 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 35356-616_0e2de965-00aa-4624-b6bd-a060317c6122 35356-616 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20120306 ANDA ANDA075078 Lake Erie Medical & Surgical Supply DBA Qualtiy Care Products LLC ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-619_f66ee285-f07a-43e2-8e79-d2a2a66aac51 35356-619 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20120309 ANDA ANDA078525 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 35356-621_313bfba3-51b5-41fe-80c2-2d2032977dc8 35356-621 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20111114 ANDA ANDA078154 Lake Eire Medical & Surgical Supply DBA Quality Care Products LLC LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 35356-622_30e15f1d-fdcd-4982-865c-c109da177f18 35356-622 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM DR PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA091231 Lake Erie Medical DBA Quality Care Products LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 35356-623_430a7902-08d0-46ea-984d-674c9b8604fd 35356-623 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Lake Erie Medical DBA Quality Care Products LLC ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 35356-625_06553d77-f5fb-4fca-9448-eac6bb246b85 35356-625 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Lake Erie Medical DBA Quality Care Products LLC MILNACIPRAN HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-627_2d2f31c6-98e7-4519-9fb6-ffb1107cbad4 35356-627 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081126 ANDA ANDA077715 Lake Erie Medical DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 35356-630_155fe25a-9097-450d-9305-a361a4b96e63 35356-630 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET ORAL 20090514 ANDA ANDA078273 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-635_c7274269-63db-46ba-a397-13064c625fb5 35356-635 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20130109 ANDA ANDA076258 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-636_29b74b8b-762b-47ea-9373-90864e969d13 35356-636 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-637_29b74b8b-762b-47ea-9373-90864e969d13 35356-637 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-638_29b74b8b-762b-47ea-9373-90864e969d13 35356-638 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-639_29b74b8b-762b-47ea-9373-90864e969d13 35356-639 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-642_976b64c1-d064-4cb7-a824-fdfba6b94043 35356-642 HUMAN OTC DRUG Dendracin Neurodendraxcin Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20111114 OTC MONOGRAPH NOT FINAL part348 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CAPSAICIN; MENTHOL; METHYL SALICYLATE .015; 6; 18 mL/60mL; mL/60mL; mL/60mL 35356-643_bccb9a07-262b-40c9-a395-3c1043b1c746 35356-643 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20111129 ANDA ANDA090964 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-644_60f6bb1f-d15f-492a-8d1b-366ecc5f641d 35356-644 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20120403 ANDA ANDA075410 Lake Erie Medical DBA Quality Care Products LLC OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 35356-645_49e70830-6872-45db-b782-18d337b41aa7 35356-645 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070427 ANDA ANDA077214 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 35356-647_7a9d758c-d6df-4dda-91f8-837139881018 35356-647 HUMAN PRESCRIPTION DRUG SPEEDGEL RX ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE GEL TRANSDERMAL 20111201 UNAPPROVED HOMEOPATHIC Lake Erie Medical DBA Quality Care Products LLC ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL 1; 3; 1; 3; 1; 1; 1; 3; 3; 1; 1; 1; 1; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 35356-648_8631a6fe-01c3-4a40-af4d-a53ee5c68238 35356-648 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20120403 ANDA ANDA040400 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 35356-649_20ea4f7f-f1b2-4256-ae19-441e844cd92f 35356-649 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride TABLET, FILM COATED ORAL 20100113 ANDA ANDA075755 Lake Erie Medical DBA Quality Care Products LLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-650_0689a8d5-705f-45ef-9aad-efbf910dd7e8 35356-650 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20120403 ANDA ANDA070791 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 35356-651_eb834045-6333-4d82-9b2a-1d221d1d89c0 35356-651 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073553 Lake Erie Medical DBA Quality Care Products LLC NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 35356-652_7060ce2d-7426-4b18-902a-4d2dee6e64e1 35356-652 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20120403 ANDA ANDA077050 Lake Erie Medical DBA Quality Care Products LLC ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 35356-653_ff795d3c-1dfc-4c57-b40d-85c289b94798 35356-653 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20120402 ANDA ANDA071611 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 35356-654_4b1a5e8d-4857-42a5-bf8b-2ec8552747c0 35356-654 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120403 ANDA ANDA089883 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 35356-655_f8518954-230a-4643-a671-c689319e7a84 35356-655 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20101231 ANDA ANDA079046 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-656_63e05976-e850-42a6-bfb1-d29a0580e5d4 35356-656 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 35356-658_a7ce6ebd-c0ef-40b5-ae45-03975d3598a8 35356-658 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TRIAMCINOLONE ACETONIDE 1 mg/g 35356-659_62c6f2a4-9366-45b9-8cff-95051c313418 35356-659 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20091123 ANDA ANDA076003 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 35356-660_4621244e-064d-4656-82ac-5c095ee8e8bc 35356-660 HUMAN PRESCRIPTION DRUG Tramadol hydrochloride and acetaminophen tramadol hydrochloride and acetaminophen TABLET ORAL 20050421 ANDA ANDA076475 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 35356-661_c6a3118f-116c-411d-8a2e-ad79b262443f 35356-661 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen tramadol hydrochloride and acetaminophen TABLET, COATED ORAL 20010815 NDA NDA021123 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 35356-662_c48f74e3-5c0f-48ec-a437-1ac1f3820a66 35356-662 HUMAN PRESCRIPTION DRUG TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET ORAL 20070206 ANDA ANDA076347 Lake Erie Medical DBA Quality Care Products LLC TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 35356-663_29314e56-9120-4e7b-9bb1-a990c760a3a2 35356-663 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 Lake Erie Medical DBA Quality Care Products LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 35356-664_29314e56-9120-4e7b-9bb1-a990c760a3a2 35356-664 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 Lake Erie Medical DBA Quality Care Products LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 35356-666_bb0657cf-c903-402d-95b4-4999ed2f3c55 35356-666 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 35356-668_fc9d5d10-15d7-4208-8254-2acacd65f6ce 35356-668 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-669_fc9d5d10-15d7-4208-8254-2acacd65f6ce 35356-669 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-670_598c9292-493f-4729-ab55-fb19906430bf 35356-670 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Lake Erie Medical DBA Quality Care Products LLC RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 35356-672_067abd63-7dcf-4cb9-9abc-592cc54a4954 35356-672 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20121105 ANDA ANDA040185 Lake Erie Medical DBA Quality Care Products LLC PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 35356-673_32261038-0fc2-4233-87c6-519c889e6ba2 35356-673 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19720522 ANDA ANDA080292 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PREDNISONE 5 mg/1 35356-674_bf5930a4-c03e-4d50-8d1d-f96fde8e03f2 35356-674 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19740226 ANDA ANDA083677 Lake Erie Medical & Surgial Supply DBA Quality Care Products LLC PREDNISONE 20 mg/1 35356-677_9f62f728-a97e-4570-b3e5-a6073dfe0d8f 35356-677 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA085162 Lake Erie Medical DBA Quality Care Products LLC PREDNISONE 10 mg/1 35356-678_afdef8b1-8c65-4520-854b-f88fa6a30a74 35356-678 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20110726 ANDA ANDA078139 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 35356-679_4b7b0d18-4513-470d-9ef0-5d5f491e511c 35356-679 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Lake Erie Medical DBA Quality Care Products LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 35356-680_a0668680-11fa-418c-a6cd-0aab058cd202 35356-680 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073554 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 35356-681_27a3bac0-06dd-4c02-9372-d67183cbe93f 35356-681 HUMAN PRESCRIPTION DRUG Nitrofurantoin (macrocrystals) nitrofurantoin (macrocrystals) CAPSULE ORAL 20120430 ANDA ANDA077025 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 35356-682_f76349ce-eba3-4c5b-9e7f-7aa89ccd1ffb 35356-682 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-683_0290fa5c-3417-413b-9363-08780907d68e 35356-683 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-685_a55c8498-7a57-4110-8545-3b3a3522afe0 35356-685 HUMAN PRESCRIPTION DRUG Nabumetone Nabumentone TABLET ORAL 20020225 ANDA ANDA075280 Lake Erie Medical DBA Quality Care Products LLC NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-686_e03b8121-b8c0-48b8-8873-1d3db68422a8 35356-686 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-687_7bc15015-75f0-47e9-90df-12efddb6d580 35356-687 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20110613 ANDA ANDA091083 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-688_476b7939-aa80-48ff-b7c6-511ecd34085e 35356-688 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Lake Erie Medical DBA Quality Care Products LLC MIRTAZAPINE 30 mg/1 35356-689_14563eaf-cadd-4b6a-9fe1-1383bce351fa 35356-689 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 35356-690_ccc3694b-3dde-4bbe-a426-f870049dfdfb 35356-690 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Lake Erie Medical DBA Quality Care Products LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 35356-692_75cb7f58-d6cc-4851-a261-8f201e7efeaf 35356-692 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20120214 ANDA ANDA077921 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-693_75cb7f58-d6cc-4851-a261-8f201e7efeaf 35356-693 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20120214 ANDA ANDA077921 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-694_26ea4d0e-6a7b-4a60-9996-c7a0484bf2ff 35356-694 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 Lake Erie Medical DBA Quality Care Products LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 35356-696_30f0a05b-a9dd-4df8-b6c6-a3d5e56e3228 35356-696 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20100420 ANDA ANDA074754 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-697_955276b4-e3f3-4b98-922f-84ad8bed3397 35356-697 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-698_28dbd035-be3e-4d3d-b318-563b1055c7db 35356-698 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-699_8f2513ce-55a1-4f07-a9ae-9aef4ddf79f3 35356-699 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Lake Erie Medical DBA Quality Care Products LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-701_b781ea50-9426-4673-96ce-660456beecff 35356-701 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 35356-702_c540b314-0cec-44c2-a803-8dd5bc0dd396 35356-702 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110801 ANDA ANDA040807 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 35356-703_9fc4325e-f91a-406e-843d-2f5d3a256240 35356-703 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19910830 ANDA ANDA081080 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 35356-704_2c43a247-d188-4f71-84ec-a4253082b09f 35356-704 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065211 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 35356-706_1fc9ccd8-08c3-4376-9643-c2d0b9435e7a 35356-706 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040400 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 35356-707_c62841eb-4e64-4bd3-807b-47ddae772709 35356-707 HUMAN PRESCRIPTION DRUG GENTAMICIN SULFATE gentamicin sulfate SOLUTION/ DROPS OPHTHALMIC 19980105 ANDA ANDA062452 Lake Erie Medical & Surgical Suppy DBA Quality Care Products LLC GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 35356-708_a68a987a-bbfd-4473-919d-6b5f87f21a05 35356-708 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 35356-709_b00102d2-c7ad-4915-a94d-a1ed3b57c231 35356-709 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 35356-710_e02124f2-fb73-40de-a42f-1216d3214e81 35356-710 HUMAN PRESCRIPTION DRUG Flurbiprofen flurbiprofen TABLET, FILM COATED ORAL 20110520 ANDA ANDA074358 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLURBIPROFEN 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-711_2e0d5790-7fdb-45c4-954d-5a616a4d6312 35356-711 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980311 ANDA ANDA075074 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-712_78fda66a-2ef8-4215-994e-090545335452 35356-712 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 35356-713_b7012bb5-d4a7-4b2a-894b-5b0e390a88b0 35356-713 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19980811 ANDA ANDA075219 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-714_7e43fa4c-9ae1-4169-8a5b-6a5fd8f69917 35356-714 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-716_7c9e8449-fed2-471c-80e8-40faebe61bde 35356-716 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071135 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 35356-717_73b706cf-4910-48b0-92e1-22edfb18b01b 35356-717 HUMAN PRESCRIPTION DRUG cyclobenzaprine hydrochloride cyclobenzaprine hydrochloride TABLET ORAL 20100423 ANDA ANDA077563 Lake Erie Medical DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 35356-718_d5292c86-3364-4b2c-9f7f-4584ce555c6c 35356-718 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-719_ac7d0a73-f830-417f-8bf9-9299025fcfb9 35356-719 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 35356-720_d5292c86-3364-4b2c-9f7f-4584ce555c6c 35356-720 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-721_c81ab486-d3ce-4663-8474-22ffc019a389 35356-721 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19871101 ANDA ANDA087499 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 35356-722_349a7943-1ba3-45e5-8388-ffac45912f54 35356-722 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960917 ANDA ANDA074569 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 35356-723_c3fff3c5-ec45-4c48-939e-4f94025ad4fe 35356-723 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 35356-724_7c9e8449-fed2-471c-80e8-40faebe61bde 35356-724 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071136 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 35356-725_7e43fa4c-9ae1-4169-8a5b-6a5fd8f69917 35356-725 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20101231 ANDA ANDA090066 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-727_3cbe3116-4328-4e77-9564-0e25f16949ca 35356-727 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 35356-728_696b54ae-459c-4d75-ad0d-3f7bb935a45e 35356-728 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Lake Erie Medical DBA Quality Care Products LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-729_bd9aa124-c73f-485e-aa4d-b56795582514 35356-729 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine CAPSULE ORAL 20050720 ANDA ANDA076990 Lake Erie Medical DBA Quality Care Products LLC FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-730_935215c8-e1d4-4e25-a5e1-a2aa0ed8f882 35356-730 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20120727 ANDA ANDA075786 Lake Erie Medical DBA Quality Care Products LLC FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 35356-732_dff97f6f-caaf-46f2-aef4-13e6c7fbfb64 35356-732 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 35356-734_c1489023-8661-490e-9606-de03711da382 35356-734 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19960124 ANDA ANDA040124 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 35356-736_23f27033-1d66-462a-93ea-b7dea07298fe 35356-736 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20101020 ANDA ANDA074584 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 35356-738_7b1454be-b5c3-4b47-99fc-40b7e5cc38ae 35356-738 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20110130 ANDA ANDA077877 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 35356-739_4030fa9d-6eab-4449-8e4f-bbc703f02b4d 35356-739 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 35356-742_54da0e4c-8478-498b-b100-fc09b2719c26 35356-742 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 35356-743_54da0e4c-8478-498b-b100-fc09b2719c26 35356-743 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085967 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 35356-744_d68daef5-5cbb-4ddd-9256-448b53a7fc73 35356-744 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 35356-745_49e70830-6872-45db-b782-18d337b41aa7 35356-745 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070427 ANDA ANDA077214 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 35356-746_e1c7f4f4-54cf-4921-9bae-69fac33ed085 35356-746 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20091201 ANDA ANDA077918 Lake Erie Medical DBA Quality Care Products LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-747_1a8b6e3f-b7b0-4a00-b026-f769cb871c09 35356-747 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070108 ANDA ANDA071141 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 35356-748_7a48e38f-1e12-4f51-8cba-79594efa75fb 35356-748 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20101101 ANDA ANDA074198 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-749_db967d98-be9f-4e8d-b5ab-438b1c002fa8 35356-749 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 35356-751_c035ee75-b190-461b-bc9f-c5173b1b3b45 35356-751 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20071210 NDA NDA021977 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LISDEXAMFETAMINE DIMESYLATE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 35356-752_2e6097a4-f519-4437-851a-ab1c0fd20773 35356-752 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 35356-753_04172536-bc87-4ae1-920f-2908ae0d3904 35356-753 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19971126 ANDA ANDA040039 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TRIAMCINOLONE ACETONIDE 1 mg/g 35356-754_a836d071-6ac3-45a5-af09-ba587e8c1f2c 35356-754 HUMAN PRESCRIPTION DRUG Lactulose lactulose SOLUTION ORAL 20010726 ANDA ANDA075993 Lake Erie Medical DBA Quality Care Products LLC LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 35356-755_9c97e0ec-4a1a-4eaf-804a-16249918744e 35356-755 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA078050 Lake Erie Medical DBA Quality Care Products LLC ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 35356-756_bc8626c9-549c-4461-b991-3b3bb3d40f2b 35356-756 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Lake Erie Medical DBA Quality Care Products LLC OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 35356-758_ef469442-32b5-465c-aeaf-37f9805b6c8a 35356-758 HUMAN PRESCRIPTION DRUG Testim testosterone GEL TRANSDERMAL 20021031 NDA NDA021454 Lake Erie Medical DBA Quality Care Products LLC TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 35356-759_410c5db5-394f-4cbe-89bc-168f207a9d42 35356-759 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Lake Erie Medical DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 35356-760_c3a2891a-c632-4dc4-a1ee-fd768fa44410 35356-760 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110621 ANDA ANDA078424 Lake Erie Medical DBA Quality Care Products LLC LEVOFLOXACIN 750 mg/1 35356-761_1493001e-858a-46d3-98b6-3093adb8f460 35356-761 HUMAN PRESCRIPTION DRUG ENDOCET Oxycodone and Acetaminophen TABLET ORAL 20000526 ANDA ANDA040330 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-762_1493001e-858a-46d3-98b6-3093adb8f460 35356-762 HUMAN PRESCRIPTION DRUG ENDOCET Oxycodone and Acetaminophen TABLET ORAL 20030306 ANDA ANDA040434 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-763_a9130e10-50dc-4ef0-98fa-e26b7fc473c8 35356-763 HUMAN PRESCRIPTION DRUG MethylPREDNISolone methylprednisolone TABLET ORAL 19981222 ANDA ANDA040183 Lake Erie Medical DBA Quality Care Products LLC METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 35356-765_afa6dcb8-2346-41ca-90b6-5abdf4a8e5dd 35356-765 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20110829 ANDA ANDA078722 Lake Erie Medical DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 35356-766_d01f435c-5942-43eb-a0c2-0e23a5451591 35356-766 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen HYDROCODONE BITARTRATE, ACETAMINOPHEN TABLET ORAL 20120517 ANDA ANDA040846 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 35356-767_720e027e-fd27-4aac-b19b-ffd81d0c3b82 35356-767 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120314 NDA NDA022370 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 35356-768_b830420b-77b5-4263-858c-6776a42450a2 35356-768 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA091231 Lake Erie Medical DBA Quality Care Products LLC PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 35356-770_5ee2c0da-e618-4e77-b0ca-14bb0dfdbed4 35356-770 HUMAN PRESCRIPTION DRUG NUCYNTA ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110825 NDA NDA200533 Lake Erie Medical DBA Quality Care Products LLC TAPENTADOL HYDROCHLORIDE 100 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 35356-771_cddfdb22-1fd2-4502-a35a-c75de4ab36c8 35356-771 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA078434 Lake Erie Medical DBA Quality Care Products LLC KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-772_0dd0ae26-00b1-4b9c-bb9f-5c506782665e 35356-772 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lake Erie Medical DBA Quality Care Products LLC LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 35356-773_2d9ef975-4011-490b-b9b2-cb02247a10d3 35356-773 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101014 ANDA ANDA078243 Lake Erie Medical DBA Quality Care Products LLC LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 35356-774_d124758d-1438-42d8-b844-ca87c9777b38 35356-774 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 35356-775_1b2bfb16-d457-43a0-b4d0-e6d2dd7ec45e 35356-775 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Lake Erie Medical DBA Quality Care Products LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 35356-776_fc70ef31-60e7-4e25-b8c6-0b433ff3bde6 35356-776 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM diclofenac sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020109 ANDA ANDA075910 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-777_ebb8f2f7-2bd8-4826-82bb-3047ee923414 35356-777 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060927 ANDA ANDA077912 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 35356-778_ebb8f2f7-2bd8-4826-82bb-3047ee923414 35356-778 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060927 ANDA ANDA077912 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 35356-779_2d9ef975-4011-490b-b9b2-cb02247a10d3 35356-779 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101014 ANDA ANDA078243 Lake Erie Medical DBA Quality Care Products LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 35356-780_b595ea16-8ce5-41e2-b1cb-b451ac20bc90 35356-780 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100406 ANDA ANDA077157 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 35356-781_1b2bfb16-d457-43a0-b4d0-e6d2dd7ec45e 35356-781 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Lake Erie Medical DBA Quality Care Products LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 35356-782_5e78d3f8-4bc2-4a0c-b4dd-2d5f58a6b52b 35356-782 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 35356-783_daab10c4-1f80-4718-bb17-28e1868b5d79 35356-783 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Lake Erie Medical DBA Quality Care Products LLC LEVOFLOXACIN 500 mg/1 35356-784_b0503934-5499-4de7-8cb6-388a48735577 35356-784 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET, FILM COATED ORAL 20110906 ANDA ANDA090199 Lake Erie Medical DBA Quality Care Products LLC LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 35356-785_48b7271c-f3d4-4cb1-9f6e-4ab47a915e7c 35356-785 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-786_48b7271c-f3d4-4cb1-9f6e-4ab47a915e7c 35356-786 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-787_48b7271c-f3d4-4cb1-9f6e-4ab47a915e7c 35356-787 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-789_48b7271c-f3d4-4cb1-9f6e-4ab47a915e7c 35356-789 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-790_60207bcd-04aa-4c7f-864a-0a4513a01ad5 35356-790 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111212 ANDA ANDA201384 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 35356-791_aa649871-64ac-4710-8dfc-8876cce3cb42 35356-791 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-792_9abe3702-cdf1-421c-b012-6168a00ece86 35356-792 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 35356-793_8d446e7c-8afa-4d90-834d-66628cd1b2d0 35356-793 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100427 ANDA ANDA078938 Lake Erie Medical DBA Quality Care Products LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 35356-794_827fa543-03ae-4770-a65f-5e14be605c23 35356-794 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20090817 ANDA ANDA040833 Lake Erie Medical DBA Quality Care Products LLC ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 35356-795_78ac344f-7ee3-416c-94d6-9287e5be5a72 35356-795 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120412 ANDA ANDA201013 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 35356-796_78ac344f-7ee3-416c-94d6-9287e5be5a72 35356-796 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120412 ANDA ANDA201013 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 35356-797_78ac344f-7ee3-416c-94d6-9287e5be5a72 35356-797 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120412 ANDA ANDA201013 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 35356-798_c74b34d2-ec38-4c2b-8dd3-8ace7338dc94 35356-798 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 20020524 NDA AUTHORIZED GENERIC NDA050784 Lake Erie Medical DBA Quality Care Products LLC AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 35356-799_52d8b1b5-b4a6-4b0e-b691-fe7e870483ab 35356-799 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20130508 ANDA ANDA078777 Lake Erie Medical DBA Quality Care Products LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-800_52d8b1b5-b4a6-4b0e-b691-fe7e870483ab 35356-800 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20130502 ANDA ANDA078777 Lake Erie Medical DBA Quality Care Products LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-801_39ddd18b-00bd-48b8-857d-a89aeaef0b9e 35356-801 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20120802 ANDA ANDA202677 Lake Erie Medical DBA Quality Care Product s LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-802_39ddd18b-00bd-48b8-857d-a89aeaef0b9e 35356-802 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20120802 ANDA ANDA202677 Lake Erie Medical DBA Quality Care Product s LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-803_58a592a8-07f4-403f-8d2b-bbd7e104aa71 35356-803 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 35356-804_820e579d-2cb3-4fb5-9988-cdf90b4b10dc 35356-804 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 Lake Erie Medical DBA Quality Care Products LLC Care Producst HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 35356-805_cb8a543a-87b5-4ae5-977a-d3c67a441105 35356-805 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070227 ANDA ANDA040755 Lake Erie Medical DBA Quality Care Products LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 35356-806_9d33a2a1-bd98-453d-9f29-7808998a4c30 35356-806 HUMAN PRESCRIPTION DRUG Clonidine Clonidine PATCH, EXTENDED RELEASE TRANSDERMAL 20100825 ANDA ANDA079090 Lake Erie Medical DBA Quality Care Products LLC CLONIDINE .2 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 35356-807_71ba0dce-9ad2-4db0-930d-222b0ccdea5b 35356-807 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20100315 ANDA ANDA090510 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 35356-808_273bdac0-73b1-4fb4-a35b-38e1051ee3c4 35356-808 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Lake Erie Medical DBA Quality Care Products LLC MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-809_6ad5233b-1cf6-48a0-a7e3-8e4c580a16ac 35356-809 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Lake Erie Medical DBA Quality Care Products LLC RANITIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 35356-810_4da50452-c87c-470e-aae3-b234d1291e64 35356-810 HUMAN PRESCRIPTION DRUG NUCYNTA ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110825 NDA NDA200533 Lake Erie Medical DBA Quality Care Products LLC TAPENTADOL HYDROCHLORIDE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 35356-811_cbf0fffa-061a-4a53-b590-98d68df7a718 35356-811 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20110114 ANDA ANDA075876 Lake Erie Medical DBA Quality Care Products LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 35356-812_def362fc-0061-4569-87a8-86cfa52aeaa6 35356-812 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071322 Lake Erie Medical DBA Quality Care Products LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 35356-813_ccc3694b-3dde-4bbe-a426-f870049dfdfb 35356-813 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Lake Erie Medical DBA Quality Care Products LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 35356-814_b3c1d1eb-2e14-4879-96c3-d46cb33f4183 35356-814 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA077471 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-815_b3c1d1eb-2e14-4879-96c3-d46cb33f4183 35356-815 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA078439 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-816_b3c1d1eb-2e14-4879-96c3-d46cb33f4183 35356-816 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA078439 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-817_310e3cf1-a378-4b70-a0d1-549c8cccac63 35356-817 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040777 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; OXYCODONE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-818_71e842d3-c635-4517-806e-99c3e6c9ea06 35356-818 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA087342 Lake Erie Medical DBA Quality Care Products LLC PREDNISONE 20 mg/1 35356-819_71e842d3-c635-4517-806e-99c3e6c9ea06 35356-819 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 Lake Erie Medical DBA Quality Care Products LLC PREDNISONE 5 mg/1 35356-820_9db5a633-15a3-4824-974e-8a77e444c0fe 35356-820 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA201655 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-821_29314e56-9120-4e7b-9bb1-a990c760a3a2 35356-821 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20120628 ANDA ANDA071457 Lake Erie Medical DBA Quality Care Products LLC TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 35356-822_95de3bec-31b0-440c-8e26-fb4006a54e72 35356-822 HUMAN OTC DRUG Promolaxin Docusate sodium TABLET ORAL 20110415 OTC MONOGRAPH NOT FINAL part334 Lake Erie Medical DBA Quality Care Products LLC DOCUSATE SODIUM 100 mg/1 35356-823_55a9cb2a-2c00-4e4a-adce-d48cc6ce1b23 35356-823 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 20120822 ANDA ANDA040209 Lake Erie Medical DBA Quality Care Products LLC TRIFLUOPERAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 35356-825_9db5a633-15a3-4824-974e-8a77e444c0fe 35356-825 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA201655 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-826_1d4d5ad3-394b-4574-b4d3-f35eec6bebb5 35356-826 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980520 ANDA ANDA075009 Lake Erie Medical DBA Quality Care Products LLC ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-827_8fefe708-accf-4321-895c-29e859061ac5 35356-827 HUMAN PRESCRIPTION DRUG Erythromycin Base Erythromycin TABLET, FILM COATED ORAL 20110906 ANDA ANDA061621 Lake Erie Medical DBA Quality Care Products LLC ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 35356-828_44aeb86d-4ee6-4973-8f43-ba9f66ea9201 35356-828 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20090512 ANDA ANDA090659 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-829_44aeb86d-4ee6-4973-8f43-ba9f66ea9201 35356-829 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20090512 ANDA ANDA090659 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-830_44aeb86d-4ee6-4973-8f43-ba9f66ea9201 35356-830 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20090512 ANDA ANDA090659 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-831_5398edf9-dfb9-4af4-8196-2ea5cab3e9a7 35356-831 HUMAN OTC DRUG Medrox METHYL SALICYLATE, MENTHOL, CAPSAICIN OINTMENT TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part348 Lake Erie Medical DBA Quality Care Products LLC CAPSAICIN; MENTHOL; METHYL SALICYLATE .0375; 5; 20 g/100g; g/100g; g/100g 35356-832_fe06b0b9-9e79-41bd-b9a1-ffe80d078b6a 35356-832 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET ORAL 20070102 ANDA ANDA077670 Lake Erie Medical DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-833_01b156bf-e761-43e9-849e-036a3e2937ad 35356-833 HUMAN PRESCRIPTION DRUG morphine sulfate extended release morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-834_d6982b60-2b0c-4112-a167-c25c7e3f93f4 35356-834 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 Lake Erie Medical DBA Quality Care Products LLC METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-835_d6982b60-2b0c-4112-a167-c25c7e3f93f4 35356-835 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 Lake Erie Medical DBA Quality Care Products LLC METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-836_01b156bf-e761-43e9-849e-036a3e2937ad 35356-836 HUMAN PRESCRIPTION DRUG morphine sulfate extended release morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-837_01b156bf-e761-43e9-849e-036a3e2937ad 35356-837 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074769 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-838_01b156bf-e761-43e9-849e-036a3e2937ad 35356-838 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-839_1d6fb40c-3081-447c-8479-b3e544656cb6 35356-839 HUMAN PRESCRIPTION DRUG Oxycodone Hydchloride Oxycodone Hydchloride TABLET ORAL 20111220 ANDA ANDA091393 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-840_e4dcc7b4-78e3-4f61-821a-dbd8ab96cf29 35356-840 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040789 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; OXYCODONE 650; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-841_4f1ef3c0-a556-47f9-a708-e052a7c0871b 35356-841 HUMAN PRESCRIPTION DRUG morphine sulfate extended release morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074769 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-843_24049bea-a28e-4015-a4e3-f7a8c84abb42 35356-843 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20100115 NDA NDA021427 Lake Erie Medical DBA Quality Care Products LLC DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-844_8e6435b4-855e-4bfa-ba4a-795144ac75e9 35356-844 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20130305 ANDA ANDA077657 Lake Erie Medical DBA Quality Care Products LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 35356-845_a0f1b181-4d9a-4983-b3f5-7e8797f3e690 35356-845 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101013 ANDA ANDA078179 Lake Erie Medical DBA Quality Care Products LLC ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 35356-846_4daf43f6-c0c0-40b7-a64c-d3fe821d86f2 35356-846 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 35356-847_73b706cf-4910-48b0-92e1-22edfb18b01b 35356-847 HUMAN PRESCRIPTION DRUG cyclobenzaprine hydrochloride cyclobenzaprine hydrochloride TABLET ORAL 20060404 ANDA ANDA077563 Lake Erie Medical DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 35356-848_9db5a633-15a3-4824-974e-8a77e444c0fe 35356-848 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA201655 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-849_9db5a633-15a3-4824-974e-8a77e444c0fe 35356-849 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA201655 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-850_0fe78b3f-0231-4a52-9bcc-07362ce2eb0b 35356-850 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20080711 ANDA ANDA076017 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 35356-851_c901630f-2fa4-4057-82cf-8e655835e378 35356-851 HUMAN OTC DRUG Cough Guaifenesin LIQUID ORAL 20091204 OTC MONOGRAPH FINAL part341 Lake Erie Medical DBA Quality Care Products LLC GUAIFENESIN 100 mg/5mL 35356-852_23c40cff-640c-43d2-8f81-3230a234f457 35356-852 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 NDA AUTHORIZED GENERIC NDA020699 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-853_ee0f636e-0a98-4845-8798-20afd8a6d55a 35356-853 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070727 ANDA ANDA077851 Lake Erie Medical DBA Quality Care Products LLC ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 35356-855_cd343223-770f-45e4-b6fc-099b0a44a989 35356-855 HUMAN OTC DRUG MEDROX MENTHOL, CAPSAICIN PATCH TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part348 Lake Erie Medical DBA Quality Care Products LLC CAPSAICIN; MENTHOL .0375; 5 g/100g; g/100g 35356-856_5074f6f3-d9bf-4c55-9454-e45d4e871318 35356-856 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Lake Erie Medical DBA Quality Care Products LLC ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 35356-858_096c94fc-84ab-47c3-bd31-bbcbfda501ff 35356-858 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 35356-859_8cb1aedd-1174-49e4-ac42-d9f88b29d2e2 35356-859 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone atenolol and chlorthalidone TABLET ORAL 20130328 ANDA ANDA074203 Lake Erie Medical DBA Quality Care Products LLC ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 35356-861_ecff66ee-c7a1-438a-a455-0a076936a11a 35356-861 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Lake Erie Medical DBA Quality Care Products LLC BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 35356-862_f9fde4a5-53be-4d8b-a56a-cd35704d51e8 35356-862 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030825 ANDA ANDA040513 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 35356-865_e4377712-8f98-4756-928c-92668cbe9cd5 35356-865 HUMAN OTC DRUG diphenhydramine hydrochloride diphenhydramine hydrochloride CAPSULE ORAL 20000501 OTC MONOGRAPH FINAL part341 Lake Erie Medical DBA Quality Care Products LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 35356-866_4a8739a4-914b-413f-8536-30a6d47d6d7c 35356-866 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Lake Erie Medical DBA Quality Care Products LLC DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 35356-867_9cff1028-0c3b-4a40-a689-cb924bc59cc2 35356-867 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960308 NDA NDA020254 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-868_9e771bb9-65ec-4cb1-adf9-b782704284e7 35356-868 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20090101 ANDA ANDA077031 Lake Erie Medical DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-869_6747aee4-3931-4cd5-b7f5-f45b75af1ccc 35356-869 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Lake Erie Medical DBA Quality Care Products LLC ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 35356-871_6747aee4-3931-4cd5-b7f5-f45b75af1ccc 35356-871 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Lake Erie Medical DBA Quality Care Products LLC ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 35356-873_74b60a0b-0ae0-4fe0-bcbc-62b75003ce9f 35356-873 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 Lake Erie Medical DBA Quality Care Products LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 35356-875_36f09e83-04f0-4331-b442-65c8292f57ec 35356-875 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110301 ANDA ANDA074550 Lake Erie Medical DBA Quality Care Products LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 35356-876_e098c2ac-07ad-41b2-a9d2-65a233a468f7 35356-876 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20071214 ANDA ANDA070719 Lake Erie Medical DBA Quality Care Products LLC INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 35356-877_1f062eb5-b14e-401a-9382-8f75267e1dec 35356-877 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Lake Erie Medical DBA Quality Care Products LLC LEVOFLOXACIN 250 mg/1 35356-879_0dfe544f-6081-4b3b-b639-886e50402108 35356-879 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20070215 ANDA ANDA077321 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 35356-881_30a35593-92a9-4d91-80a3-c8dd38b27707 35356-881 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 Lake Erie Medical DBA Quality Care Products LLC LORATADINE 10 mg/1 35356-882_b2d00a76-23e2-4d7c-ac16-a1f5a5f39369 35356-882 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20011211 ANDA ANDA076045 Lake Erie Medical DBA Quality Care Products LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 35356-883_b0ae887b-5521-484d-ad82-5c8054e29e52 35356-883 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Lake Erie Medical DBA Quality Care Products LLC LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 35356-884_b0ae887b-5521-484d-ad82-5c8054e29e52 35356-884 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Lake Erie Medical DBA Quality Care Products LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 35356-885_acf8437b-25ee-45f9-bfdc-1bdac40911ce 35356-885 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 Lake Erie Medical DBA Quality Care Products LLC LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 35356-886_de1114f7-aaec-44b3-b539-4708c54b76cc 35356-886 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 35356-887_789d0a15-8a37-4eaf-acba-c638af573280 35356-887 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 Lake Erie Medical DBA Quality Care Products LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 35356-888_e5318a59-bb7d-41fe-813b-25f93ba1bc4a 35356-888 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 35356-889_a2561b14-d410-4e94-bf53-d61235ba7ead 35356-889 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 35356-890_766d9f66-8479-4479-8cc6-71b151683644 35356-890 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110822 ANDA ANDA070044 Lake Erie Medical DBA Quality Care Products LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 35356-891_c2cbd3ba-8b79-4867-b2a9-50515327da57 35356-891 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE ORAL 20101013 ANDA ANDA075576 Lake Erie Medical DBA Quality Care Products LLC OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 35356-892_a2caab72-4627-4463-a25d-7bfdd8a9f92a 35356-892 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 Lake Erie Medical DBA Quality Care Products LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 35356-893_398cab9f-fe4c-4984-8f25-f4584754c06c 35356-893 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080624 ANDA ANDA077470 Lake Erie Medical DBA Quality Care Products LLC RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 35356-894_c4e4932f-5c62-4a7c-acc5-f2de597b731b 35356-894 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130709 ANDA ANDA090548 Lake Erie Medical DBA Quality Care Products LLC ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 35356-895_c7e6a876-8391-4c27-ad5f-0f7de0bc3d7c 35356-895 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070924 Lake Erie Medical DBA Quality Care Products LLC CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 35356-896_ff87b26f-fd4c-46a0-a3f9-3b7704a4af01 35356-896 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Lake Erie Medical DBA Quality Care Products LLC GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 35356-897_88a4e935-dac5-48d6-bef2-7c823582d978 35356-897 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20070507 ANDA ANDA076345 Lake Erie Medical DBA Quality Care Products LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 35356-898_e5318a59-bb7d-41fe-813b-25f93ba1bc4a 35356-898 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 35356-899_ea93ccfe-e1b2-435f-85ee-b7ed7c004fbd 35356-899 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Lake Erie Medical DBA Quality Care Products LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 35356-900_8ad72871-99cc-4540-abd4-3978b3972a00 35356-900 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20091103 OTC MONOGRAPH FINAL part343 Lake Erie Medical DBA Quality Care Products LLC ASPIRIN 81 mg/1 35356-901_c793e424-4fc0-492e-9661-7fddea119d46 35356-901 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride TABLET ORAL 20100604 ANDA ANDA040659 Lake Erie Medical DBA Quality Care Products LLC MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 35356-902_af0f7d5e-f799-4347-a6a1-db19e7beeb13 35356-902 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Lake Erie Medical DBA Quality Care Products LLC BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 35356-903_ad1c9180-5a5d-4cf6-b302-cd7a97c1cc84 35356-903 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 20120921 ANDA ANDA077309 Lake Erie Medical DBA Quality Care Products LLC ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 35356-904_aa10f0d9-98d3-44e8-b787-85a19d9d1c22 35356-904 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19900930 ANDA ANDA089763 Lake Erie Medical DBA Quality Care Products LLC THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 35356-905_b52fb200-11da-43b6-977b-6b86bdf078db 35356-905 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 Lake Erie Medical DBA Quality Care Products LLC FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 35356-906_2f437238-c8f0-4c31-b74a-74f5a558649d 35356-906 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Lake Erie Medical DBA Quality Care Products LLC WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 35356-907_4a8739a4-914b-413f-8536-30a6d47d6d7c 35356-907 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951226 ANDA ANDA074185 Lake Erie Medical DBA Quality Care Products LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 35356-908_8e5d0aa4-4785-4d75-b352-a6f96e5f3783 35356-908 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Lake Erie Medical DBA Quality Care Products LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 35356-909_e1235056-dd31-4977-ad44-08ca332b2a01 35356-909 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20070511 ANDA ANDA076745 Lake Erie Medical DBA Quality Care Products LLC OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 35356-910_ecff66ee-c7a1-438a-a455-0a076936a11a 35356-910 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Lake Erie Medical DBA Quality Care Products LLC BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 35356-911_547e45bc-fafd-44c9-bc56-d2cfcf92bc17 35356-911 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Lake Erie Medical DBA Quality Care Products LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 35356-912_af0f7d5e-f799-4347-a6a1-db19e7beeb13 35356-912 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Lake Erie Medical DBA Quality Care Products LLC BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 35356-913_1456f777-bef4-4be5-9e86-4f54f7bbea8a 35356-913 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20100226 ANDA ANDA077690 Lake Erie Medical DBA Quality Care Products LLC QUINAPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 35356-914_c793e424-4fc0-492e-9661-7fddea119d46 35356-914 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride TABLET ORAL 20100604 ANDA ANDA040659 Lake Erie Medical DBA Quality Care Products LLC MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 35356-915_096c94fc-84ab-47c3-bd31-bbcbfda501ff 35356-915 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 35356-916_27fcd422-d5d8-4e7f-91ad-9b93f3d7a6f4 35356-916 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20100201 ANDA ANDA076509 Lake Erie Medical DBA Quality Care Products LLC FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 35356-917_b41cd77b-a260-4f74-a39a-b3f29d52bcca 35356-917 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 35356-919_05123f92-a855-489b-a361-882f7e6b01c6 35356-919 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20110718 ANDA ANDA076341 Lake Erie Medical DBA Quality Care Products LLC PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 35356-920_74b60a0b-0ae0-4fe0-bcbc-62b75003ce9f 35356-920 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 Lake Erie Medical DBA Quality Care Products LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 35356-921_05123f92-a855-489b-a361-882f7e6b01c6 35356-921 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20110718 ANDA ANDA076341 Lake Erie Medical DBA Quality Care Products LLC PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 35356-922_de1114f7-aaec-44b3-b539-4708c54b76cc 35356-922 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 35356-923_1f062eb5-b14e-401a-9382-8f75267e1dec 35356-923 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Lake Erie Medical DBA Quality Care Products LLC LEVOFLOXACIN 500 mg/1 35356-924_6b3c015f-9400-42cc-9328-894360ff7527 35356-924 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Lake Erie Medical DBA Quality Care Products LLC LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 35356-925_b52fb200-11da-43b6-977b-6b86bdf078db 35356-925 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 Lake Erie Medical DBA Quality Care Products LLC FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 35356-926_935215c8-e1d4-4e25-a5e1-a2aa0ed8f882 35356-926 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 Lake Erie Medical DBA Quality Care Products LLC FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 35356-927_96d1bd8f-7685-4205-8c62-94a535073eba 35356-927 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20001020 ANDA ANDA075536 Lake Erie Medical DBA Quality Care Products LLC DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 35356-928_7f53dc64-e0bf-4008-9623-293baba563f0 35356-928 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20130502 ANDA ANDA075593 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 35356-929_c4e4932f-5c62-4a7c-acc5-f2de597b731b 35356-929 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130709 ANDA ANDA090548 Lake Erie Medical DBA Quality Care Products LLC ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 35356-930_34da6242-0058-4a6d-8a60-8cfe52b28c34 35356-930 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 ANDA ANDA074052 Lake Erie Medical DBA Quality Care Products LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 35356-931_2d64cdce-e861-418a-bb75-b313b50b85bb 35356-931 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031107 ANDA ANDA076467 Lake Erie Medical DBA Quality Care Products LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 35356-932_88a4e935-dac5-48d6-bef2-7c823582d978 35356-932 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20070614 ANDA ANDA076345 Lake Erie Medical DBA Quality Care Products LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 35356-933_6b3c015f-9400-42cc-9328-894360ff7527 35356-933 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Lake Erie Medical DBA Quality Care Products LLC LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 35356-934_c3fd08d2-2fc3-446d-a97b-a41b37f5b10a 35356-934 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA077118 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 35356-935_799ae026-edd4-494f-877d-e24a2705923c 35356-935 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Lake Erie Medical DBA Quality Care Products LLC SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 35356-936_4008a90d-26f2-447d-a50f-641202ed038f 35356-936 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine GEL TOPICAL 20130301 UNAPPROVED DRUG OTHER Lake Erie Medical DBA Quality Care Products LLC LIDOCAINE 30 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 35356-937_e4dcc7b4-78e3-4f61-821a-dbd8ab96cf29 35356-937 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040778 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; OXYCODONE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35356-938_1390e270-b179-4dea-9ad1-f50511f0089c 35356-938 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19840701 ANDA ANDA088496 Lake Erie Medical DBA Quality Care Products LLC HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 35356-939_71614375-c7c1-4281-84e3-34d663bc887a 35356-939 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040788 Lake Erie Medical DBA Quality Care Products LLC HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 35356-942_71614375-c7c1-4281-84e3-34d663bc887a 35356-942 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040787 Lake Erie Medical DBA Quality Care Products LLC HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 35356-943_2f8836c9-e05d-4d41-9e85-d3501f8953b3 35356-943 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 Lake Erie Medical DBA Quality Care Products LLC HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 35356-944_54609dc3-08bc-447e-b07f-387702ca119d 35356-944 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Lake Erie Medical DBA Quality Care Products LLC HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 35356-945_6747aee4-3931-4cd5-b7f5-f45b75af1ccc 35356-945 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Lake Erie Medical DBA Quality Care Products LLC ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 35356-946_d3bf5705-ae3f-4e41-bf44-31fcd9101452 35356-946 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Lake Erie Medical DBA Quality Care Products LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 35356-947_6b6d79b1-390e-48a8-bb50-264f26177c0f 35356-947 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Lake Erie Medical DBA Quality Care Products LLC DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 35356-948_0dfe544f-6081-4b3b-b639-886e50402108 35356-948 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20070215 ANDA ANDA077321 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 35356-949_b0ae887b-5521-484d-ad82-5c8054e29e52 35356-949 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Lake Erie Medical DBA Quality Care Products LLC LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 35356-950_c3ff129e-2a0a-4fdc-a00d-289b1ab96de0 35356-950 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20060824 ANDA ANDA077242 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 35356-951_9fbcc31e-0e41-4f67-b28a-b1473bfc83de 35356-951 HUMAN PRESCRIPTION DRUG Cilostazol cilostazol TABLET ORAL 20111018 ANDA ANDA077030 Lake Erie Medical DBA Quality Care Products LLC CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 35356-952_f9c003c7-915f-46fe-ac67-7c94f3666490 35356-952 HUMAN PRESCRIPTION DRUG Nifedipine Extended Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20120529 ANDA ANDA077899 Lake Erie Medical DBA Quality Care Products LLC NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 35356-954_7f068867-807a-4288-bdaf-bf7492569200 35356-954 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Lake Erie Medical DBA Quality Care Products LLC ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 35356-955_6b3c015f-9400-42cc-9328-894360ff7527 35356-955 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Lake Erie Medical DBA Quality Care Products LLC LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 35356-957_3b0fd791-2bdc-44b5-ba21-b62da2ee0c68 35356-957 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100706 ANDA ANDA090190 Lake Erie Medical DBA Quality Care Products LLC PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 35356-958_498a9c09-edb3-4bb4-9f4f-235f00a14d14 35356-958 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 19900930 ANDA ANDA071655 Lake Erie Medical DBA Quality Care Products LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 35356-959_2c828a4d-a922-4b4e-b8f1-3fefd5e0328e 35356-959 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 35356-960_2794b368-9349-41a5-a2a7-0f788d22b607 35356-960 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 35356-961_50e56ba5-4e44-4b0f-bb15-f33b6bd3ab74 35356-961 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040423 ANDA ANDA076483 Lake Erie Medical DBA Quality Care Products LLC FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 35356-962_3ec36099-eb62-4167-918a-225886c82c06 35356-962 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075317 Lake Erie Medical DBA Quality Care Products LLC TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 35356-963_261b4ec9-0c42-4ecb-a32a-af7c8730ab37 35356-963 HUMAN OTC DRUG New Terocin Methyl Salicylate, Capsaicin, and Menthol LOTION TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part348 Lake Erie Medical DBA Quality Care Products LLC CAPSAICIN; MENTHOL; METHYL SALICYLATE .025; 10; 25 g/100mL; g/100mL; g/100mL 35356-964_b676952e-2ede-485b-9faf-ee13cdb138cd 35356-964 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Lake Erie Medical DBA Quality Care Products LLC SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC] 35356-965_2794b368-9349-41a5-a2a7-0f788d22b607 35356-965 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 35356-967_978d680d-5bb1-456a-89d6-7fe631f983ef 35356-967 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20130211 ANDA ANDA203601 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 35356-968_978d680d-5bb1-456a-89d6-7fe631f983ef 35356-968 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20130211 ANDA ANDA203601 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 35356-969_9f23c329-5f18-4adb-a856-172a70d42364 35356-969 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20070103 ANDA ANDA040353 Lake Erie Medical DBA Quality Care Products LLC SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 35356-970_77d95bd2-5cb6-4873-a822-49e5509e3ae1 35356-970 HUMAN PRESCRIPTION DRUG Glipizide and Metformin HCl Glipizide and Metformin HCl TABLET, FILM COATED ORAL 20100629 ANDA ANDA078728 Lake Erie Medical DBA Quality Care Products LLC GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 35356-971_4a8739a4-914b-413f-8536-30a6d47d6d7c 35356-971 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Lake Erie Medical DBA Quality Care Products LLC DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 35356-972_54609dc3-08bc-447e-b07f-387702ca119d 35356-972 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Lake Erie Medical DBA Quality Care Products LLC HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 35356-973_8c95641d-28cb-4716-9675-cb17ab43416c 35356-973 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 35356-974_6a7f64ce-e12d-4877-a633-d822874280d5 35356-974 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 19970605 ANDA ANDA074821 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 35356-978_a14f0751-d98f-47ab-9398-d94387ffe056 35356-978 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110120 ANDA ANDA090836 Lake Erie Medical DBA Quality Care Products LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 35356-980_0fc7f64f-0bc9-4d4d-b23c-2a33d3ff0110 35356-980 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 19900930 ANDA ANDA062702 Lake Erie Medical DBA Quality Care Products LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 35356-981_3fca9693-10cd-45da-9c81-992f17a5f161 35356-981 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091568 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 35356-982_3fca9693-10cd-45da-9c81-992f17a5f161 35356-982 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091569 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 35356-983_67683692-d868-4218-897c-a9022d397978 35356-983 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20060329 ANDA ANDA065255 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 35356-984_9315f99a-4598-4a8b-b631-1aaea4152f3f 35356-984 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 35356-985_5822769c-2f5f-4fe6-9e7d-25b426db8288 35356-985 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19880225 ANDA ANDA062881 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 35356-986_0de01c94-51b8-4808-8247-925033848cb7 35356-986 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120112 ANDA ANDA062058 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 35356-987_75719797-80a5-4a70-9059-4387fb5366e1 35356-987 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET ORAL 20000215 ANDA ANDA040327 Lake Erie Medical DBA Quality Care Products LLC ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 35356-988_af0f7d5e-f799-4347-a6a1-db19e7beeb13 35356-988 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Lake Erie Medical DBA Quality Care Products LLC BUMETANIDE .5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 35356-989_f2b57029-f50b-4c67-b6b8-fc9bf31af16b 35356-989 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20050713 ANDA ANDA065228 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 35356-990_12e2ab6c-6724-4330-90af-e864776f3241 35356-990 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20121024 ANDA ANDA077027 Lake Erie Medical DBA Quality Care Products LLC CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 35356-991_41a97fcd-3cf3-46c1-86e7-3d09077db63f 35356-991 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20090301 ANDA ANDA078503 Lake Erie Medical DBA Quality Care Products LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 35356-993_e2fe9292-f8a4-4dc2-b6ad-e3a429650cff 35356-993 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130613 ANDA ANDA200270 Lake Erie Medical DBA Quality Care Products LLC ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 35356-995_ad11d5fb-c1eb-4f00-a811-6e6baeb644cc 35356-995 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Lake Erie Medical DBA Quality Care Products LLC GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 35356-997_3b0fd791-2bdc-44b5-ba21-b62da2ee0c68 35356-997 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100706 ANDA ANDA090190 Lake Erie Medical DBA Quality Care Products LLC PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 35356-998_6f05f8e2-2fae-4434-ab18-f0f8a76a963d 35356-998 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride/Hydrochlorothiazide Quinapril Hydrochloride/Hydrochlorothiazide TABLET, FILM COATED ORAL 20070824 ANDA ANDA078450 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 35356-999_34beb750-b5cd-4ac4-914c-81d6906fcb3d 35356-999 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20111017 ANDA ANDA077312 Lake Erie Medical DBA Quality Care Products LLC FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 35378-0002_b46e9a34-442d-e4b4-6951-29d265e94951 35378-0002 HUMAN OTC DRUG Boost Remedy Water Adrenalinum, Aloe, Arsenicum alb., Baptisia, Berber. aqui., Berber. vulg., Bryonia, Chelidonium majus, Crotalus horridus, Digitalis, Ferrum metallicum, Glonoinum, Glycyrrhiza glabra, Hydrocotyle, Iodium, Iris versicolor, Lachesis, Lycopodium, Nat. mur., Nux vom., Rhus toxicodendron, Ruta, Thuja occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum PELLET ORAL 20120701 UNAPPROVED HOMEOPATHIC Georgetown Health, LLC DBA EssentiaLife ALOE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CENTELLA ASIATICA; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GLYCYRRHIZA GLABRA; IODINE; IRIS VERSICOLOR ROOT; IRON; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAHONIA AQUIFOLIUM ROOT BARK; NITROGLYCERIN; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 3; 15; 15; 15 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 35378-0004_d4ce08ae-71e5-374d-0db4-59919e9bddb3 35378-0004 HUMAN OTC DRUG Calm Remedy Water Aconitum nap., Arg. nit., Aut. met., Baptisia, Bryonia, Chelidonium majus, Cimicifuga, Conium, Gelsemium, Ignatia, Kali carb., Lachesis, Lilum, Lycopodium, Nat. carb., Nat. mur., Phosphoricum ac., Phosphorus, Picricum ac., Plumb. met., Sepia, Staphysag., Stramonium, Thuja occ., Zinc. met., Chomomilla, Hypericum, Valeriana PELLET ORAL 20120701 UNAPPROVED HOMEOPATHIC Georgetown Health, LLC DBA EssentiaLife ACONITUM NAPELLUS; BAPTISIA TINCTORIA ROOT; BLACK COHOSH; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; GOLD; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LEAD; LILIUM LANCIFOLIUM BULB; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THUJA OCCIDENTALIS LEAFY TWIG; TRINITROPHENOL; VALERIAN; ZINC 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 35378-0006_a1446b4f-37d5-ce89-d211-d7a4ac858ac0 35378-0006 HUMAN OTC DRUG Control Remedy Water Anacardium orientale, Antimon. crud., Arg. nit., Berber. vulg., Bryonia, Chelidonium majus, Digitalis, Graphites, Humulus, Iris Versicolor, SOLUTION ORAL 20120701 UNAPPROVED HOMEOPATHIC Georgetown Health, LLC DBA EssentiaLife ANTIMONY TRISULFIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DATURA STRAMONIUM; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWER; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 35378-0008_a0827118-9a02-24b0-4e70-9141b2f78d32 35378-0008 HUMAN OTC DRUG Cleanse Remedy Water Uricum acidum, Benzoicum acidum, Berber. vulg., Bryonia,Cantharis, Carduus benedictus,Ceanothus, Chelidonium majus, Chionanthus virginica,Cinchona, Dioscorea, Dolichos, Iris versicolor, Juniperus com, Nux vom., Ptelea, Taraxacum, Carduus mar., Cynara scolymus, Solidago, Taraxacum PELLET ORAL 20120701 UNAPPROVED HOMEOPATHIC Georgetown Health, LLC DBA EssentiaLife BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CNICUS BENEDICTUS; CYNARA SCOLYMUS LEAF; DIOSCOREA VILLOSA ROOT; IRIS VERSICOLOR ROOT; JUNIPERUS COMMUNIS WHOLE; LYTTA VESICATORIA; MUCUNA PRURIENS FRUIT TRICHOME; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TARAXACUM OFFICINALE; URIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 3; 3; 10; 10; 3; 15 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 35378-0010_7cee29cf-2094-93b8-4113-2bc3fccf739b 35378-0010 HUMAN OTC DRUG Ease Remedy Water Aconitum nap., Antimon. tart., Arg. nit., Arnica, Bryona, Chamomilla, Chelidonium majus, Cimicifuga, Eupatorium perf., Hypericum, Nux vom., Rhus toxicodendron, Ruta, Sarcolacticum ac., Stramonium, Strychnium, Chamomilla, Phytolacca, Ruta, Symphytum PELLET ORAL 20120701 UNAPPROVED HOMEOPATHIC Georgetown Health, LLC DBA EssentiaLife ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BLACK COHOSH; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COMFREY ROOT; DATURA STRAMONIUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; HYPERICUM PERFORATUM; LACTIC ACID, L-; MATRICARIA RECUTITA; MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE; STRYCHNINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 3; 3; 15; 3; 15; 15; 15; 15 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 35378-0012_ef0aa2f2-26bc-f129-ed03-4e74dcbb2f38 35378-0012 HUMAN OTC DRUG Nobacco Remedy Water Arsenicum alb., Benzoicum acidum, Berber. vulg, Bryonia, Caladium seguinum, Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Daphne indica, Ignatia, Iris versicolor, Lycopodium, Nicotinum, Nux vom., Rhus toxicodendron, Scutellaria lateriflora, Tabacum, Echinacea, Taraxacum, Valeriana PELLET ORAL 20120701 UNAPPROVED HOMEOPATHIC Georgetown Health, LLC DBA EssentiaLife ARSENIC TRIOXIDE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DAPHNE ODORA BARK; DIEFFENBACHIA SEGUINE; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; NICOTINE; SCUTELLARIA LATERIFLORA; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 35418-111_11e82391-4104-433d-b401-dd19c56bc33c 35418-111 HUMAN OTC DRUG Histenol Forte II Phenylephrine HCl, Acetaminophen, Guaifenesin TABLET ORAL 20120612 OTC MONOGRAPH FINAL part341 Zee Medical Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 100; 5 mg/1; mg/1; mg/1 35418-119_6061da5a-3e25-48b6-bd8a-9ad5ab18fc65 35418-119 HUMAN OTC DRUG Cough Syrup DM Guaifenesin, Dextromethorpham HBr SYRUP ORAL 20120612 OTC MONOGRAPH FINAL part341 Zee Medical Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 35418-123_0250ecd3-28c2-45ad-aeba-690fd57a6be8 35418-123 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 20140116 ANDA ANDA074091 Zee Medical Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 35418-136_e9bfade6-443a-4372-ac40-9c9367fb43d3 35418-136 HUMAN OTC DRUG Dilotab II Acetaminophen Phenylephrine TABLET ORAL 20120612 OTC MONOGRAPH NOT FINAL part343 Zee Medical Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 35418-203_3a4035c3-164d-44cc-b228-87dac9b2e8fe 35418-203 HUMAN OTC DRUG Alcohol Prep pad Isopropyl Alcohol SWAB TOPICAL 20130115 OTC MONOGRAPH FINAL part344 ZEE MEDICAL ISOPROPYL ALCOHOL .7 mL/mL 35418-210_9dea7120-07f3-4be1-b63d-827fef39377d 35418-210 HUMAN OTC DRUG Zee Unaspirin ES Acetaminophen TABLET ORAL 20120612 OTC MONOGRAPH NOT FINAL part343 Zee Medical Inc ACETAMINOPHEN 500 mg/1 35418-232_f0ecf84c-f8ec-4ba3-a114-f3e2c2fe6c64 35418-232 HUMAN OTC DRUG Zee Aspirin Aspirin TABLET ORAL 20120612 OTC MONOGRAPH NOT FINAL part343 Zee Medical Inc ASPIRIN 325 mg/1 35418-233_1ac45745-7dea-4265-882b-429b7a76221b 35418-233 HUMAN OTC DRUG Zee-Seltzer Antacid and Pain Reliever Aspirin, Citric Acid Monohydrate, and Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20060814 OTC MONOGRAPH FINAL part343 ZEE MEDICAL ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 35418-242_20129136-dd93-438c-a532-288e2948fd0e 35418-242 HUMAN OTC DRUG Zee Pain Aid Acetaminophen Salicylamide Aspirin TABLET ORAL 20120612 OTC MONOGRAPH NOT FINAL part343 Zee Medical Inc ACETAMINOPHEN; ASPIRIN; SALICYLAMIDE 110; 162; 152 mg/1; mg/1; mg/1 35418-263_27aa100d-f80d-4410-868f-3527f67e506c 35418-263 HUMAN OTC DRUG Insect Sting Relief Wipes BENZOCAINE, ISOPROPYL ALCOHOL SWAB TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 ZEE MEDICAL BENZOCAINE; ISOPROPYL ALCOHOL 60; .6 mg/mL; mL/mL 35418-310_fd0f349b-9899-49c3-b740-3f77c661ce36 35418-310 HUMAN OTC DRUG Trial Antacid Calcium Carbonate TABLET ORAL 20120612 OTC MONOGRAPH FINAL part331 Zee Medical Inc CALCIUM CARBONATE 420 mg/1 35418-334_87300767-d3fb-42fe-9b92-490a670ce3bd 35418-334 HUMAN OTC DRUG Congestaid II Phenylephrine Hydrochloride TABLET ORAL 20120612 OTC MONOGRAPH NOT FINAL part341 Zee Medical Inc PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 35418-402_144c688f-1c02-409a-b4c0-9f402cb97d8f 35418-402 HUMAN OTC DRUG Isopropyl Alcohol Alcohol SPRAY TOPICAL 20100708 OTC MONOGRAPH NOT FINAL part333E Zee Medical ALCOHOL 70 mL/100mL 35418-560_88b72224-2aba-4d0b-9ac0-43f784485b27 35418-560 HUMAN OTC DRUG Pain Aid ESF Acetaminophen, Aspirin, Caffeine TABLET ORAL 20120612 OTC MONOGRAPH NOT FINAL part343 Zee Medical Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 35418-631_bfb9f71d-0f19-48bc-9800-72809f13341e 35418-631 HUMAN OTC DRUG Mouth Sore Medication benzocaine LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part356 Zee Medical BENZOCAINE 200 mg/g 35418-710_f6ad4ae3-238c-4340-a5e1-3db7a2886533 35418-710 HUMAN OTC DRUG Pain Aid PMF Acetaminophen, Pamabrom TABLET ORAL 20120612 OTC MONOGRAPH NOT FINAL part343 Zee Medical Inc ACETAMINOPHEN; PAMABROM 500; 25 mg/1; mg/1 35418-750_259369b4-8c31-4579-ada7-71f44ca31961 35418-750 HUMAN OTC DRUG Ibutab Ibuprofen TABLET ORAL 20120612 ANDA ANDA079129 Zee Medical Inc IBUPROFEN 200 mg/1 35418-801_0666a0e7-7c33-4230-b455-a06c897a28f5 35418-801 HUMAN OTC DRUG Pain Aid BRF Acetaminophen Magnesium Salicylate TABLET ORAL 20120819 OTC MONOGRAPH NOT FINAL part343 Zee Medical Inc ACETAMINOPHEN; MAGNESIUM SALICYLATE 250; 250 mg/1; mg/1 35501-023_eeae604c-98fa-40dc-b205-9aa8184c9b10 35501-023 HUMAN PRESCRIPTION DRUG ZFLEX Acetaminophen and Phenyltoloxamine Citrate TABLET ORAL 20100412 UNAPPROVED DRUG OTHER Huckaby Pharmaceuticals, Inc. ACETAMINOPHEN; PHENYLTOLOXAMINE CITRATE 500; 55 mg/1; mg/1 35567-0001_c81173eb-2820-46ab-8745-313fda80ef7b 35567-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990101 UNAPPROVED MEDICAL GAS Uptown Pharmacy of Kingsman OXYGEN 99 L/100L 35573-006_be8820fb-884f-4b67-9632-e8c0b36d8cd0 35573-006 HUMAN OTC DRUG RelCof-C Codeine Phosphate and Guaifenesin LIQUID ORAL 20090902 OTC MONOGRAPH FINAL part341 Burel Pharmaceuticals, LLC CODEINE PHOSPHATE; GUAIFENESIN 6.3; 100 mg/5mL; mg/5mL 35573-103_28ccc65c-7e07-4315-ae4f-d46bec774366 35573-103 HUMAN PRESCRIPTION DRUG RELNATE DHA OMEGA-3 FATTY ACIDS, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, FOLIC ACID, CHOLECALCIFEROL, ASCORBIC ACID, ALPHA-TOCOPHEROL, CUPRIC SULFATE ANHYDROUS, ZINC OXIDE, IRO CAPSULE, LIQUID FILLED ORAL 20110515 UNAPPROVED DRUG OTHER Burel Pharmaceuticals, LLC ALPHA-TOCOPHEROL; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE ANHYDROUS; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 30; 100; 400; 1; 15; 1; 28; 30; 200; 20; 3; 3; 20 [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 35573-200_28ccc65c-7e07-4315-ae4f-d46bec774366 35573-200 HUMAN PRESCRIPTION DRUG RELNATE DHA OMEGA-3 FATTY ACIDS, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, FOLIC ACID, CHOLECALCIFEROL, ASCORBIC ACID, ALPHA-TOCOPHEROL, CUPRIC SULFATE ANHYDROUS, ZINC OXIDE, IRO CAPSULE, LIQUID FILLED ORAL 20110515 UNAPPROVED DRUG OTHER Burel Pharmaceuticals, LLC ALPHA-TOCOPHEROL; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE ANHYDROUS; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 30; 100; 400; 1; 15; 1; 28; 30; 200; 20; 3; 3; 20 [iU]/1; [iU]/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 35617-392_5549a1c2-a26b-4367-a399-9e354c7ee0c0 35617-392 HUMAN OTC DRUG Povidone-Iodine Prep Pad Povidone-Iodine SWAB PERCUTANEOUS 20100517 OTC MONOGRAPH FINAL part333C NANTONG STRIP MEDICAL SUPPLY CO.,LTD. POVIDONE-IODINE 10 mL/1 35617-393_806658e8-00f1-4184-96cf-695a09bb882b 35617-393 HUMAN OTC DRUG Benzalkonium Chloride Antiseptic benzalkonium chloride SWAB TOPICAL 20100520 OTC MONOGRAPH FINAL part348 NANTONG STRIP MEDICAL SUPPLY CO.,LTD. BENZALKONIUM CHLORIDE .004 mL/1 35617-394_926a20c4-4740-4ba7-9aab-9425721b2477 35617-394 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20100524 OTC MONOGRAPH FINAL part348 NANTONG STRIP MEDICAL SUPPLY CO.,LTD. ISOPROPYL ALCOHOL .7 mL/1 35617-395_25bb85a9-3735-41ce-b8d1-d161f0d39eaf 35617-395 HUMAN OTC DRUG Sting Relief Benzocaine,Alcohol SWAB TOPICAL 20100524 OTC MONOGRAPH FINAL part348 NANTONG STRIP MEDICAL SUPPLY CO.,LTD. ALCOHOL; BENZOCAINE .6; .06 mL/1; mL/1 35617-396_d7222229-7952-432b-9a8d-936825469ae7 35617-396 HUMAN OTC DRUG Alcohol ISOPROPYL ALCOHOL SWAB TOPICAL 20110620 OTC MONOGRAPH FINAL part344 NANTONG STRIP MEDICAL SUPPLY CO.,LTD. ISOPROPYL ALCOHOL .7 mL/1 35617-397_9bea2c38-9eac-4b4d-b28f-cebf3de14d88 35617-397 HUMAN OTC DRUG Povidone-Iodine Povidone-Iodine SWAB PERCUTANEOUS 20110620 OTC MONOGRAPH NOT FINAL part333E NANTONG STRIP MEDICAL SUPPLY CO.,LTD. POVIDONE-IODINE .1 mL/1 35617-399_ff5a9591-a0a6-4094-8368-c6c2b565c481 35617-399 HUMAN OTC DRUG Cleansing Wipe / Tube SODIUM CHLORIDE SWAB TOPICAL 20120812 OTC MONOGRAPH FINAL part349 NANTONG STRIP MEDICAL SUPPLY CO.,LTD. SODIUM CHLORIDE .9 g/100mL 35781-0194_9135b37f-d8f4-44ae-a7b3-677a1c83ee84 35781-0194 HUMAN PRESCRIPTION DRUG TRANZGEL ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM GEL TRANSDERMAL 20100701 UNAPPROVED HOMEOPATHIC Gensco Laboratories, LLC ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL 1; 3; 3; 3; 1; 1; 1; 3; 4; 1; 1; 1; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 35781-0210_1880a81d-e2f6-4eab-79e3-1eb3666610ca 35781-0210 HUMAN PRESCRIPTION DRUG SPEEDGEL RX ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE GEL TRANSDERMAL 20111201 UNAPPROVED HOMEOPATHIC Gensco Laboratories, LLC ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL 1; 3; 1; 3; 1; 1; 1; 3; 3; 1; 1; 1; 1; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 35781-0230_ab5093da-fe6e-437f-94bd-d233a3683967 35781-0230 HUMAN OTC DRUG INFLAM-X Aconitum Napellus, Arnica Montana, Belladonna, Bellis Perennis, Calendula Officinallis, Chamomilla, Echinacea Angustifolia, Echinacea Purpurea, Hamamellis Virginiana, Hypericum Perforatum, Millefolium, Symphytum Officinale, Zingiber Officinale GEL TOPICAL 20100617 UNAPPROVED HOMEOPATHIC Gensco Laboratories, LLC ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWER; CHAMOMILE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM 1; 3; 3; 4; 1; 1; 1; 4; 1; 1; 1; 1; 1 [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL 35781-0300_c58f13c8-bed8-4319-b23f-3629d36cb7c4 35781-0300 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine GEL TOPICAL 20130301 UNAPPROVED DRUG OTHER Gensco Laboratories, LLC LIDOCAINE 30 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 35813-373_6e2f940f-8aab-430a-aef6-cf358737b649 35813-373 HUMAN OTC DRUG DIAPEDIC FOOT TREATMENT MENTHOL LOTION TOPICAL 20110831 OTC MONOGRAPH NOT FINAL part348 ANASTASIA MARIE LABORATORIES, INC. MENTHOL 1.5 mg/g 35813-374_56f90ad3-67ce-41eb-aeea-4ee81c55c6b4 35813-374 HUMAN OTC DRUG DIAPEDIC FOOT AND LEG TREATMENT MENTHOL CREAM TOPICAL 20110831 OTC MONOGRAPH NOT FINAL part348 ANASTASIA MARIE LABORATORIES, INC. MENTHOL 1.5 g/100g 35831-001_77924bb9-7a25-4b24-ab4c-28ecbfd8df44 35831-001 HUMAN OTC DRUG Master HG Aralia quonquefolia 3X, Arnica montana 3X, Carduus marianus 3X, Damiana 3X, Galium aparine 3X, Hamamelis virginiana 3X, Hepar suis 6X, Natrum muriaticum 200C, Phosphoricum acidum 3X, Pituitarum posterium 30X, Taraxacum officinale 200C, Thuja occidentalis 200C LIQUID SUBLINGUAL 20130416 UNAPPROVED HOMEOPATHIC Great American Products, Inc AMERICAN GINSENG; ARNICA MONTANA; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PHOSPHORIC ACID; PORK LIVER; SILYBUM MARIANUM SEED; SODIUM CHLORIDE; SUS SCROFA PITUITARY GLAND; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TURNERA DIFFUSA LEAFY TWIG 3; 3; 3; 3; 3; 6; 3; 200; 30; 3; 200; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL 35896-001_904cff57-9047-4ed7-84c8-fadd4d0fff8b 35896-001 HUMAN OTC DRUG Super HG aralia quinquefolia, arnica montana, carduus marianus, damiana, galium aparine, hamamelis virginiana, hepar suis, natrum muriaticum, phosphoricum acidum, pituitarum posterium, taraxacum officinale, thuja occidentalis LIQUID SUBLINGUAL 20130515 UNAPPROVED HOMEOPATHIC Physician's Choice, Inc. AMERICAN GINSENG; ARNICA MONTANA; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PHOSPHORIC ACID; PORK LIVER; SILYBUM MARIANUM SEED; SODIUM CHLORIDE; SUS SCROFA PITUITARY GLAND; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TURNERA DIFFUSA LEAFY TWIG 3; 3; 3; 3; 3; 6; 3; 200; 30; 3; 200; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL 36000-001_9803245b-6cfa-35fd-b55a-162cc634ce69 36000-001 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE INJECTION, SOLUTION INTRAVENOUS 20081120 ANDA ANDA078084 Claris Lifesciences Inc. METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 36000-002_a3dce794-948e-4f1b-ae0c-082116abded1 36000-002 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20100609 ANDA ANDA077909 Claris Lifesciences Inc. FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 36000-003_a3dce794-948e-4f1b-ae0c-082116abded1 36000-003 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20100609 ANDA ANDA077909 Claris Lifesciences Inc. FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 36000-004_a3dce794-948e-4f1b-ae0c-082116abded1 36000-004 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20100609 ANDA ANDA077947 Claris Lifesciences Inc. FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 36000-005_a3dce794-948e-4f1b-ae0c-082116abded1 36000-005 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20100609 ANDA ANDA077947 Claris Lifesciences Inc. FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 36000-006_a3dce794-948e-4f1b-ae0c-082116abded1 36000-006 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20100609 ANDA ANDA077988 Claris Lifesciences Inc. FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 36000-007_a3dce794-948e-4f1b-ae0c-082116abded1 36000-007 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20100609 ANDA ANDA077988 Claris Lifesciences Inc. FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 36000-008_baf41cbc-ac58-4971-9828-12a3334607e6 36000-008 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION INTRAVENOUS 20080804 ANDA ANDA078024 Claris Lifesciences Inc. CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 36000-009_baf41cbc-ac58-4971-9828-12a3334607e6 36000-009 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION INTRAVENOUS 20080804 ANDA ANDA078024 Claris Lifesciences Inc. CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 36000-010_baf41cbc-ac58-4971-9828-12a3334607e6 36000-010 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090917 ANDA ANDA078062 Claris Lifesciences Inc. CIPROFLOXACIN 10 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 36000-011_baf41cbc-ac58-4971-9828-12a3334607e6 36000-011 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090917 ANDA ANDA078062 Claris Lifesciences Inc. CIPROFLOXACIN 10 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 36000-012_29cf4121-8dc1-4225-adf4-8f90346f4b6c 36000-012 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130313 ANDA ANDA078287 Claris Lifesciences Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 36000-013_29cf4121-8dc1-4225-adf4-8f90346f4b6c 36000-013 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130313 ANDA ANDA078288 Claris Lifesciences Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 36000-014_8eef2a1d-20ea-45d2-84ef-f9e64ec84796 36000-014 HUMAN PRESCRIPTION DRUG Ondansetron hydrochloride and dextrose ondansetron hydrochloride and dextrose INJECTION, SOLUTION INTRAVENOUS 20090414 ANDA ANDA078308 Claris Lifesciences, Inc ONDANSETRON HYDROCHLORIDE 32 mg/50mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 36000-028_9803245b-6cfa-35fd-b55a-162cc634ce69 36000-028 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE INJECTION, SOLUTION INTRAVENOUS 20081120 ANDA ANDA078084 Claris Lifesciences Inc. METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 36000-029_baf41cbc-ac58-4971-9828-12a3334607e6 36000-029 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION INTRAVENOUS 20080804 ANDA ANDA078024 Claris Lifesciences Inc. CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 36000-030_baf41cbc-ac58-4971-9828-12a3334607e6 36000-030 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION INTRAVENOUS 20140801 ANDA ANDA078024 Claris Lifesciences Inc. CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 36000-033_88ba651e-b299-40a5-a8e3-469d036ad066 36000-033 HUMAN PRESCRIPTION DRUG Metoprolol metoprolol tartrate INJECTION INTRAVENOUS 20120925 ANDA ANDA078950 Claris Lifesciences Inc. METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 36000-045_f8def103-7d3a-49a2-85dc-5ed16e6f9535 36000-045 HUMAN PRESCRIPTION DRUG Levofloxacin levofloxacin INJECTION, SOLUTION INTRAVENOUS 20130701 ANDA ANDA091436 Claris Lifesciences Inc. LEVOFLOXACIN 25 mg/mL 36000-046_f8def103-7d3a-49a2-85dc-5ed16e6f9535 36000-046 HUMAN PRESCRIPTION DRUG Levofloxacin levofloxacin INJECTION, SOLUTION INTRAVENOUS 20130701 ANDA ANDA091397 Claris Lifesciences Inc. LEVOFLOXACIN 5 mg/mL 36000-047_f8def103-7d3a-49a2-85dc-5ed16e6f9535 36000-047 HUMAN PRESCRIPTION DRUG Levofloxacin levofloxacin INJECTION, SOLUTION INTRAVENOUS 20130701 ANDA ANDA091397 Claris Lifesciences Inc. LEVOFLOXACIN 5 mg/mL 36000-048_f8def103-7d3a-49a2-85dc-5ed16e6f9535 36000-048 HUMAN PRESCRIPTION DRUG Levofloxacin levofloxacin INJECTION, SOLUTION INTRAVENOUS 20130701 ANDA ANDA091397 Claris Lifesciences Inc. LEVOFLOXACIN 5 mg/mL 36000-063_0213af9c-2318-43e0-8b04-ef6363d329b6 36000-063 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION, SOLUTION INTRAVENOUS 20140206 ANDA ANDA202747 Claris Lifesciences, Inc FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 36000-064_0213af9c-2318-43e0-8b04-ef6363d329b6 36000-064 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION, SOLUTION INTRAVENOUS 20140206 ANDA ANDA202747 Claris Lifesciences, Inc FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 36000-065_0213af9c-2318-43e0-8b04-ef6363d329b6 36000-065 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION, SOLUTION INTRAVENOUS 20140206 ANDA ANDA202747 Claris Lifesciences, Inc FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 36000-070_0bfd0e69-f2ec-4ce6-a97d-e0812c65c27b 36000-070 HUMAN PRESCRIPTION DRUG Ampicillin ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100425 ANDA ANDA090354 Claris Lifesciences, Inc. AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 36000-071_0bfd0e69-f2ec-4ce6-a97d-e0812c65c27b 36000-071 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100425 ANDA ANDA090354 Claris Lifesciences, Inc. AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 36000-072_0bfd0e69-f2ec-4ce6-a97d-e0812c65c27b 36000-072 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100425 ANDA ANDA090354 Claris Lifesciences, Inc. AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 36000-073_0bfd0e69-f2ec-4ce6-a97d-e0812c65c27b 36000-073 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100425 ANDA ANDA090354 Claris Lifesciences, Inc. AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 36000-162_c284b064-f8a4-449f-8c37-291e8b0792f8 36000-162 HUMAN PRESCRIPTION DRUG Norepinephrine bitartrate Norepinephrine bitartrate INJECTION INTRAVENOUS 20120401 ANDA ANDA040859 Claris Lifesciences Inc. NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 36000-175_a56b5261-a7af-490a-865c-aadd615bf677 36000-175 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION INTRAMUSCULAR; INTRAVENOUS 20120201 ANDA ANDA090560 Claris Lifesciences, Inc. NAFCILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 36000-176_a56b5261-a7af-490a-865c-aadd615bf677 36000-176 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION INTRAMUSCULAR; INTRAVENOUS 20120201 ANDA ANDA090560 Claris Lifesciences, Inc. NAFCILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 36000-282_0213af9c-2318-43e0-8b04-ef6363d329b6 36000-282 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION, SOLUTION INTRAVENOUS 20140206 ANDA ANDA202747 Claris Lifesciences, Inc FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 36000-283_0213af9c-2318-43e0-8b04-ef6363d329b6 36000-283 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION, SOLUTION INTRAVENOUS 20140206 ANDA ANDA202747 Claris Lifesciences, Inc FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 36000-284_0213af9c-2318-43e0-8b04-ef6363d329b6 36000-284 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION, SOLUTION INTRAVENOUS 20140206 ANDA ANDA202747 Claris Lifesciences, Inc FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 36006-001_929f1937-2c6b-4186-b1ad-8e38bbcff159 36006-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Medicor Homecare, Inc. OXYGEN 99 L/100L 36769-001_f7fb4376-49a4-441e-aca6-dd5942b0b37c 36769-001 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20110204 OTC MONOGRAPH NOT FINAL part333A Buttner-Frank GmbH Arzt- und Krankenhausbedarf - Krankenpflege und Einmalartikel ISOPROPYL ALCOHOL .7 mg/mg 36769-002_a44b062a-2f5f-4652-99f0-2e53bd538bf1 36769-002 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part333A Buttner-Frank GmbH Arzt- und Krankenhausbedarf - Krankenpflege und Einmalartikel ISOPROPYL ALCOHOL .7 mg/mg 36800-001_0df1dc67-1eab-42c5-873e-719d5df755e1 36800-001 HUMAN OTC DRUG Mouth Rinse sodium fluoride MOUTHWASH ORAL 20101230 OTC MONOGRAPH FINAL part355 Topco associates LLC SODIUM FLUORIDE .1 mg/mL 36800-002_e02bd636-a34a-4364-b23e-bf6ea99e2edf 36800-002 HUMAN OTC DRUG topcare enema Dibasic sodium phosphate, Monobasic sodium phosphate ENEMA RECTAL 20091105 OTC MONOGRAPH NOT FINAL part334 Topco Associates LLC SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 36800-003_ea625319-1839-49e1-9d89-aa668bbbaa49 36800-003 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 36800-004_c9db95c3-cbcf-4af9-a2e8-402ae9c8fa7c 36800-004 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE RINSE ORAL 20040408 OTC MONOGRAPH FINAL part355 Topco Associates LLC SODIUM FLUORIDE .05 kg/100L 36800-007_b104cb32-bfad-4d6f-842b-759e1f5470a3 36800-007 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130531 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM 100 mg/1 36800-008_b08b3185-dd2d-4dac-8c47-94f15709ddc8 36800-008 HUMAN OTC DRUG Topcare infants pain relief Acetaminophen SUSPENSION/ DROPS ORAL 19980813 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 80 mg/.8mL 36800-009_2d2931a3-de29-41e2-b2ac-f05a84acf0a6 36800-009 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20091014 OTC MONOGRAPH FINAL part333D Topco Associates LLC SALICYLIC ACID 19.8 mg/g 36800-010_cf9fb683-75de-4294-a18a-20d7c2c4da88 36800-010 HUMAN OTC DRUG Topcare pain relief extra strength easy to swallow Acetaminophen TABLET, COATED ORAL 20050520 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 500 mg/1 36800-011_d5c7a9bd-fa82-4a08-8ad3-7e5d10f50027 36800-011 HUMAN OTC DRUG First Aid Antiseptic POVIDONE-IODINE SOLUTION TOPICAL 20040729 OTC MONOGRAPH NOT FINAL part333E Topco Associates LLC POVIDONE-IODINE 10 mg/mL 36800-013_14f9f782-7ea9-49b4-8c27-a565195f71ec 36800-013 HUMAN OTC DRUG Topcare Allergy Relief D Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120501 ANDA ANDA076050 Topco Associates LLC LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 36800-014_c0de28dc-5e99-405c-8bd9-e700f5a29557 36800-014 HUMAN OTC DRUG TopCare Cold NightTime Multi Symptom Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20071204 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 36800-015_3093e541-8362-44dd-810e-5cdec58da940 36800-015 HUMAN OTC DRUG Emerald Mint Health Cetylpyridinium Chloride MOUTHWASH ORAL 20130919 OTC MONOGRAPH NOT FINAL part356 TopCo Associates LLC CETYLPYRIDINIUM CHLORIDE .07 g/mL 36800-016_6645e88b-ac26-4efb-9dac-79bdff0bf053 36800-016 HUMAN OTC DRUG TopCare Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Topco Associates LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; mg/g 36800-017_7852e15f-d49f-46fa-9c84-cd2570760279 36800-017 HUMAN OTC DRUG Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20140127 OTC MONOGRAPH FINAL part347 Topco Associates LLC LANOLIN; PETROLATUM 133; 459 mg/g; mg/g 36800-018_6be8f701-114a-402b-a9a1-67d2daf764b4 36800-018 HUMAN OTC DRUG TopCare Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC HYDROCORTISONE 1 g/100g 36800-020_286d932a-9b00-4242-b642-52e10b655f89 36800-020 HUMAN OTC DRUG Diaper Rash Zinc oxide PASTE TOPICAL 19890415 OTC MONOGRAPH FINAL part347 TopCare Associates, LLC ZINC OXIDE 532 mg/g 36800-022_e081ce00-3562-418b-86b1-04e03d300ea5 36800-022 HUMAN OTC DRUG TopCare Heartburn Relief Cimetidine TABLET ORAL 20000222 ANDA ANDA075285 Topco Associates LLC CIMETIDINE 200 mg/1 36800-025_de6ff12d-efa2-4b9a-8a2b-9dcadef9826b 36800-025 HUMAN OTC DRUG TOPCARE 2 IN 1 DANDRUFF DRY SCALP PYRITHIONE ZINC LIQUID TOPICAL 20140728 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC PYRITHIONE ZINC 10 mg/mL 36800-027_1633dda0-b969-4495-8e5b-578bf89e3584 36800-027 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130315 OTC MONOGRAPH FINAL part343 TOP CARE (Topco Associates LLC) ASPIRIN 81 mg/1 36800-029_48111f58-df68-48df-888f-afc66b6af700 36800-029 HUMAN OTC DRUG TopCare Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050420 ANDA ANDA076775 Topco Associates LLC NICOTINE 2 mg/1 36800-030_0b78c0e9-c312-4ac1-b53e-f051b7b09e4b 36800-030 HUMAN OTC DRUG Aspirin enteric safety coated Aspirin TABLET ORAL 20140630 OTC MONOGRAPH NOT FINAL part343 TOP CARE (Topco Associates LLC) ASPIRIN 81 mg/1 36800-039_40c4bd98-8f60-4e29-a2a3-e169561d50b1 36800-039 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20141031 OTC MONOGRAPH FINAL part347 TOP CARE (Topco Associates LLC) WITCH HAZEL 842 mg/mL 36800-041_b054e58d-974c-46f5-ba91-a49ba2bffbc4 36800-041 HUMAN OTC DRUG Topcare Nite Time Cold and Flu acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20060612 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 36800-042_9ef393b1-8484-4321-9ad7-c9be0a7bf15e 36800-042 HUMAN OTC DRUG Pain Relief Rub Camphor,Menthol, methyl salicylate CREAM TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC CAMPHOR (NATURAL); MENTHOL; MENTHYL SALICYLATE, (+/-)- 4; 10; 30 g/100g; g/100g; g/100g 36800-044_ba091aa7-9542-4255-9f33-3ac3e99741b4 36800-044 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM 100 mg/1 36800-046_025a99af-8967-4717-9844-0a2be03c8edf 36800-046 HUMAN OTC DRUG TopCare Pain Relief Rapid Release Acetaminophen TABLET, COATED ORAL 20090810 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 500 mg/1 36800-047_1924f48f-22f5-4891-8d87-5af137fda413 36800-047 HUMAN OTC DRUG TopCare Heartburn Relief 150 Ranitidine TABLET ORAL 20080213 ANDA ANDA078653 Topco Associates LLC RANITIDINE HYDROCHLORIDE 150 mg/1 36800-050_26949321-8113-4b1a-a3a3-e222ef7cd023 36800-050 HUMAN OTC DRUG Topcare Ibuprofen PM diphenhydramine citrate and ibuprofen TABLET, COATED ORAL 20090218 ANDA ANDA079113 Topco Associates LLC DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 36800-051_1189d6d6-b691-4bc4-81fb-a43e00dd6106 36800-051 HUMAN OTC DRUG TopCare Hydrocortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC HYDROCORTISONE 1 g/100g 36800-052_fc414094-dab4-410e-9cab-486986e783d4 36800-052 HUMAN OTC DRUG TopCare Tolnaftate Antifungal Tolnaftate CREAM TOPICAL 20060217 OTC MONOGRAPH FINAL part333C Topco Associates LLC TOLNAFTATE 10 mg/g 36800-054_c692f65c-80a4-4b18-a042-58cb0903d9d4 36800-054 HUMAN OTC DRUG topcare 12 hour decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000425 ANDA ANDA075153 Topco Associates LLC PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 36800-055_91be786d-0ec4-4c10-9e3d-30752b9808da 36800-055 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140630 ANDA ANDA091353 TOP CARE (Topco Associates LLC) NAPROXEN SODIUM 220 mg/1 36800-056_022e1153-de1f-4949-a6b6-f168ea7482c8 36800-056 HUMAN OTC DRUG TopCare Triple Antibiotic Plus Pain Relief Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Topco Associates LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g 36800-057_b96403ff-5fdd-4f4d-abf0-580526b6f4e9 36800-057 HUMAN OTC DRUG Topcare Infants Ibuprofen ibuprofen SUSPENSION ORAL 20020122 ANDA ANDA075217 Topco Associates LLC IBUPROFEN 50 mg/1.25mL 36800-058_df56c898-37d7-4f1b-843a-75e7d84226d7 36800-058 HUMAN OTC DRUG Stool Softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20141031 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM 250 mg/1 36800-059_f5759319-9f4c-4538-bd78-d9e282cfc194 36800-059 HUMAN OTC DRUG TopCare Hydrocortisone 1% with Aloe Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC HYDROCORTISONE 1 g/100g 36800-060_794b85d2-c88a-47f0-bda7-d34efe248f31 36800-060 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20090929 OTC MONOGRAPH NOT FINAL part334 Top Care MINERAL OIL 15 mL/15mL 36800-061_752d6c9e-5664-4b4f-94b4-5ae54a646cda 36800-061 HUMAN OTC DRUG Nighttime Allergy Relief Extra Strength Diphenhydramine HCl TABLET ORAL 20140731 OTC MONOGRAPH FINAL part338 TOP CARE (Topco Associates LLC) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 36800-062_9cf4438c-40a4-4cba-8d4d-f8f6095f38e8 36800-062 HUMAN OTC DRUG TopCare Clotrimazole 3 Clotrimazole CREAM VAGINAL 20000412 NDA NDA021143 Topco Associates LLC CLOTRIMAZOLE 2 g/100g 36800-063_d3dd2917-c5cf-4da6-8488-c503d2ec9c2c 36800-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19910915 OTC MONOGRAPH FINAL part347 Topco Associates LLC FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL 36800-065_0336c243-853d-4d52-a8bb-1622916f1054 36800-065 HUMAN OTC DRUG Sore Throat Phenol SPRAY ORAL 20141031 OTC MONOGRAPH NOT FINAL part356 TOP CARE (Topco Associates LLC) PHENOL 1.5 g/100mL 36800-066_2705f5b5-d8ac-45c9-a50b-e52ff45dfb17 36800-066 HUMAN OTC DRUG ANTIBACTERIAL MANDARIN TRICLOSAN SOLUTION TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES L LLC TRICLOSAN .6 mL/100mL 36800-067_c9121daa-b506-49c5-a4b7-7a483fc5017c 36800-067 HUMAN OTC DRUG Antibacterial Foaming Cucumber Melon Triclosan LIQUID TOPICAL 20110902 OTC MONOGRAPH NOT FINAL part333E Topco Associates llc TRICLOSAN .6 mL/100mL 36800-068_b2533d95-95ae-4f5d-bb85-5b94c0c41440 36800-068 HUMAN OTC DRUG TOPCARE MEDICATED CLEANSING PADS WITCH HAZEL SOLUTION TOPICAL 20120301 OTC MONOGRAPH FINAL part346 TOPCO ASSOCIATES LLC WITCH HAZEL .5 mL/mL 36800-069_e05ff177-5de9-4503-8119-867421dd49f7 36800-069 HUMAN OTC DRUG Pure petroleum White Petrolatum JELLY TOPICAL 19910815 OTC MONOGRAPH FINAL part347 Topco Associates LLC PETROLATUM 1 g/g 36800-070_fb2be2e9-360f-4142-8043-d95039ce6e9d 36800-070 HUMAN OTC DRUG TopCare Miconazole 3 Yeast Infection Relief Miconazole Nitrate CREAM VAGINAL 20050302 ANDA ANDA076773 Topco Associates LLC MICONAZOLE NITRATE 40 mg/g 36800-071_2ff4b563-b806-4045-9c05-1c853d49b603 36800-071 HUMAN OTC DRUG Isopropyl Alcohol 50 Percent Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A TOP CARE (Topco Associates LLC) ISOPROPYL ALCOHOL 50 mL/100mL 36800-072_169fd50d-ba44-4cb3-bbf4-2ba01591582a 36800-072 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol MOUTHWASH ORAL 19950707 OTC MONOGRAPH NOT FINAL part348 TOPCO ASSOCIATES, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 36800-074_6eb42a2b-e69f-4d4b-b2c1-41e288ce2b40 36800-074 HUMAN OTC DRUG Topcare Ibuprofen Ibuprofen TABLET, COATED ORAL 20060410 ANDA ANDA077349 Topco Associates LLC IBUPROFEN 200 mg/1 36800-076_7f195ebc-22d2-40db-9392-52c8b5da33d2 36800-076 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111102 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC TRICLOSAN .6 mL/100mL 36800-077_f647358f-6e84-4015-af86-21e72b3340d1 36800-077 HUMAN OTC DRUG Isopropyl Alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A TOP CARE (Topco Associates LLC) ISOPROPYL ALCOHOL 91 mL/100mL 36800-078_1a98fb58-3959-46cd-a99b-9078b371858b 36800-078 HUMAN OTC DRUG TOPCARE VITAMIN E ETHYL ALCOHOL LIQUID TOPICAL 20131226 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 700 mg/mL 36800-078_cef6ec06-fee6-4708-9f48-46ea005ee776 36800-078 HUMAN OTC DRUG TOPCARE VITAMIN E ETHYL ALCOHOL LIQUID TOPICAL 20131226 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 700 mg/mL 36800-079_215322c1-75b0-48ed-9bab-416a66d0bdf6 36800-079 HUMAN OTC DRUG TOPCARE ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131118 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 700 mg/mL 36800-079_2f625f76-dac6-4450-88bc-f10abc542996 36800-079 HUMAN OTC DRUG TOPCARE ALOE ETHYL ALCOHOL LIQUID TOPICAL 20130731 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 700 mg/mL 36800-080_14c28769-cffa-4189-8e68-5b53f76f2f41 36800-080 HUMAN OTC DRUG Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Topco Associates LLC TERBINAFINE HYDROCHLORIDE 1 g/100g 36800-081_58633248-134e-477c-80ee-4720ff1dc20c 36800-081 HUMAN OTC DRUG topcare miconazole 3 combination pack Miconazole nitrate KIT 20000510 ANDA ANDA075329 Topco Associates LLC 36800-083_ecfd7e18-9867-4b06-9ecb-4bf948036326 36800-083 HUMAN OTC DRUG topcare Ibuprofen Cold and Sinus Ibuprofen, Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011009 ANDA ANDA074567 Topco Associates LLC IBUPROFEN; 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DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 36800-098_cb1ccd53-264f-46bf-b02a-c8b090c7bd77 36800-098 HUMAN OTC DRUG Daytime Sinus Relief Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20120914 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 36800-099_cc4257fd-c315-41d9-b709-f32da2ce7f23 36800-099 HUMAN OTC DRUG TopCare Hydrocortisone Intensive Healing Formula Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC HYDROCORTISONE 1 g/100g 36800-100_507785ab-856a-4d7c-aa11-54cfd5f0effd 36800-100 HUMAN OTC DRUG Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20130901 OTC MONOGRAPH FINAL part347 Topco Associates LLC ZINC OXIDE 20 g/100g 36800-101_bb73a8ea-e4c8-4fe8-b714-803e923dfc61 36800-101 HUMAN OTC DRUG Nitetime Sinus Relief Acetaminophen, Doxylamine succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20120901 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 36800-102_201062ce-440b-4524-8c64-383eed28e185 36800-102 HUMAN OTC DRUG DayTime Nitetime Sinus Relief Acetaminophen, Doxylamine succinate, Phenylephrine HCl KIT 20130115 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) 36800-103_4d5b170d-57a4-4bbc-9110-90c12c88a06b 36800-103 HUMAN OTC DRUG TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20110201 UNAPPROVED DRUG OTHER TOPCO ASSOCIATES LLC PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 36800-105_f817dccd-b2bb-418b-ad47-9e6cc7853f31 36800-105 HUMAN OTC DRUG Topcare childrens pain relief Acetaminophen SUSPENSION ORAL 19970826 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL 36800-108_6732a02b-1eff-4275-ac82-36c5f0b1d5d4 36800-108 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FOAMING HAND BERRY BLAST BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140727 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE 1.3 mg/mL 36800-109_8527a69b-2da5-4b48-9b70-12bdbacd1322 36800-109 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140728 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE 1.3 mg/mL 36800-109_ce725323-49ca-4791-bb24-a31c375dc61b 36800-109 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140728 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE 1.3 mg/mL 36800-110_bf59b053-560f-4351-be77-0cb9d9f874bd 36800-110 HUMAN OTC DRUG topcare feminine povidone-iodine KIT 20100114 OTC MONOGRAPH NOT FINAL part333A Topco Associates LLC 36800-111_3242e10d-dae8-44fc-a9d0-148571b85b27 36800-111 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM 100 mg/1 36800-112_b96473fe-346e-40ad-9767-8c600914fc8e 36800-112 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FOAMING HAND CUCUMBER MELON BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE 1.3 mg/mL 36800-114_88eed11e-ad99-4a3b-9435-39af40e943ec 36800-114 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE 1.3 mg/mL 36800-117_2f47db96-ac74-4171-aa80-9b2456515368 36800-117 HUMAN OTC DRUG Topcare Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120910 ANDA ANDA202319 Topco Associates LLC LANSOPRAZOLE 15 mg/1 36800-120_ba6c3654-00e6-4313-bb9f-ab54d3232ef0 36800-120 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20130531 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) BISACODYL 5 mg/1 36800-124_32d005d1-6924-49a1-b493-785a78f181a3 36800-124 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FOAMING HAND COMPLETE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140728 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE 1.3 mg/mL 36800-124_da83e973-ad28-467f-b322-0003cd2e3183 36800-124 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FOAMING HAND COMPLETE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140728 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE 1.3 mg/mL 36800-125_b73eea97-df63-476a-95c0-62c71b8ceb95 36800-125 HUMAN OTC DRUG Gas Relief ultra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20101004 OTC MONOGRAPH FINAL part332 TOP CARE (Topco Associates LLC) DIMETHICONE 180 mg/1 36800-130_19d0871c-0a50-4cc7-80b6-e6037708a673 36800-130 HUMAN OTC DRUG Topcare Childrens Pain Relief Acetaminophen SUSPENSION ORAL 19920720 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL 36800-133_803ec98a-379d-4b4a-8302-5edaf6d7b882 36800-133 HUMAN OTC DRUG top care flu and sore throat acetaminophen,pheniramine maleate, phenylephrine hydrochloride POWDER, FOR SUSPENSION ORAL 20100713 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 36800-136_00a96005-8d23-45af-9144-5a45608328e9 36800-136 HUMAN OTC DRUG Stomach Relief Pepto Bismol Cherry SUSPENSION ORAL 20131108 OTC MONOGRAPH FINAL part335 Top Care BISMUTH SUBSALICYLATE 262 mg/15mL 36800-138_14053c83-1b9b-499f-ba95-16a35fcdb4db 36800-138 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20130531 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) SENNOSIDES 25 mg/1 36800-139_3527e8ed-0b2a-4c39-9c8e-ca764aaa1950 36800-139 HUMAN OTC DRUG Topcare Cold and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20060912 OTC MONOGRAPH FINAL part341 Topco Associates LLC CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 36800-140_955972c2-d9f4-43ed-9100-1fbc354c81fa 36800-140 HUMAN OTC DRUG Topcare All Day Pain Relief Naproxen sodium TABLET, FILM COATED ORAL 20071203 ANDA ANDA074661 Topco Associates LLC NAPROXEN SODIUM 220 mg/1 36800-141_88722f84-dac8-4130-93b3-9e0dc1cc5acc 36800-141 HUMAN OTC DRUG TopCare Acid Reducer Famotidine TABLET ORAL 20090911 ANDA ANDA075400 Topco Associates LLC FAMOTIDINE 10 mg/1 36800-143_516ab016-31f9-4829-8b94-2f968933093c 36800-143 HUMAN OTC DRUG topcare nite time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140202 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 36800-145_d2883fbe-1141-43ee-8d4c-9986f8f06c96 36800-145 HUMAN OTC DRUG Topcare Mucus Relief cold and sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130628 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 36800-147_37d816ab-8f10-41e2-803d-26388b3fca24 36800-147 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140331 OTC MONOGRAPH NOT FINAL part343 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 36800-148_f94643aa-3e89-497a-9c8f-4ba3e697c783 36800-148 HUMAN OTC DRUG TopCare Cough Relief Honey Lemon Flavor DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL LOZENGE ORAL 20140521 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL 5; 5 mg/1; mg/1 36800-149_996686b3-5aa8-45f3-b49b-2360d7f00c23 36800-149 HUMAN OTC DRUG TopCare Cough Relief Sugar Free Cherry Flavor DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL LOZENGE ORAL 20140521 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL 5; 5 mg/1; mg/1 36800-150_d0b7f0f1-901c-4b0b-a256-f0046bc53542 36800-150 HUMAN OTC DRUG STOOL SOFTENER Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130531 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM 250 mg/1 36800-151_326fc19b-98e2-4781-b2fb-d9aa9a044f05 36800-151 HUMAN OTC DRUG topcare sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20101103 OTC MONOGRAPH FINAL part338 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 36800-152_6a1ecc77-3dfd-48e3-9d2b-2e759ae1abd6 36800-152 HUMAN OTC DRUG TopCare Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Top Care MENTHOL 750 mg/1 36800-153_ab651690-7a94-448d-82fe-8e32e865f79b 36800-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19971215 OTC MONOGRAPH FINAL part358H Topco Associates LLC PYRITHIONE ZINC 1 kg/100L 36800-154_418e02e6-93b8-4b3c-862b-fd7d0a67a9a3 36800-154 HUMAN OTC DRUG Flu Relief Therapy Night Time Acetaminophen, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20100128 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL 36800-155_7ec28230-1ccf-495f-a8b3-48a3f54ae8b7 36800-155 HUMAN OTC DRUG Top Care Medicated Menthol PATCH TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part348 Top Care MENTHOL 750 mg/1 36800-160_6d25afe1-f69d-4b6d-917f-abf1cacbd506 36800-160 HUMAN OTC DRUG ANTIBACTERIAL FOR THE KITCHEN TRICLOSAN SOLUTION TOPICAL 20110803 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC TRICLOSAN .46 mL/100mL 36800-161_2b5e15d5-78ad-47b3-b2cc-fe900617f066 36800-161 HUMAN OTC DRUG Topcare pain and fever Acetaminophen LIQUID ORAL 20110826 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL 36800-162_7a3b30f5-2dee-443b-a218-ec644e1443a4 36800-162 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20130315 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 36800-163_a04a5af5-3839-4ad3-b9d9-71c1a9ca407d 36800-163 HUMAN OTC DRUG Foaming Antibacterial Pear Triclosan SOAP TOPICAL 20100726 OTC MONOGRAPH NOT FINAL part333E Topco Associates LLC TRICLOSAN .46 mL/100mL 36800-165_b50ae833-6b5c-40ec-a5ea-f9d68f8ed9af 36800-165 HUMAN OTC DRUG Ibuprofen PM Ibuprofen and Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20110922 ANDA ANDA090397 TOP CARE (Topco Associates LLC) DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25; 200 mg/1; mg/1 36800-166_7a14a1ae-bab6-4015-b797-130dc8e933ca 36800-166 HUMAN OTC DRUG topcare childrens ibuprofen Ibuprofen SUSPENSION ORAL 20020730 ANDA ANDA074937 Topco Associates LLC IBUPROFEN 100 mg/5mL 36800-168_d1a2d469-9a1e-4ec9-8a79-205b9215da49 36800-168 HUMAN OTC DRUG TopCare Antibacterial Foaming Triclosan SOAP TOPICAL 20100722 OTC MONOGRAPH NOT FINAL part333E Topco Associates llc TRICLOSAN .6 mL/100mL 36800-169_83b371aa-6213-457f-8f53-d206c9213b7d 36800-169 HUMAN OTC DRUG ANTIBACTERIAL FOAMING COMPLETE TRICLOSAN LIQUID TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC TRICLOSAN .46 mL/100mL 36800-170_8ba3a159-f31a-439b-8a9d-1c7a72428582 36800-170 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050419 ANDA ANDA076789 Topco Associates LLC NICOTINE 4 mg/1 36800-173_236c4abe-e368-4a8a-9058-31fc6f83da50 36800-173 HUMAN OTC DRUG topcare complete lice treatment Piperonyl Butoxide, Pyrethrum Extract KIT 20071107 OTC MONOGRAPH FINAL part358 Topco Associates LLC 36800-174_771cafe4-b4c7-41e7-8edc-bacf4a21a1d4 36800-174 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20140930 NDA NDA021920 TOP CARE (Topco Associates LLC) NAPROXEN SODIUM 220 mg/1 36800-175_180e58c0-1be8-4ced-b7a9-b96d9bc91036 36800-175 HUMAN OTC DRUG Topcare childrens pain relief Acetaminophen SUSPENSION ORAL 19931214 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL 36800-176_707946c1-00b7-4170-9222-9a4d4289f719 36800-176 HUMAN OTC DRUG Topcare All Day Allergy D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080519 ANDA ANDA077170 Topco Associates LLC CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 36800-177_f2c55881-f4b9-4e89-a637-5ecee5f447d7 36800-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111107 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC TRICLOSAN .46 mL/100mL 36800-178_388638b9-d8ae-4377-9574-b6f52246b5a8 36800-178 HUMAN OTC DRUG TOPCO ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20111118 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC TRICLOSAN .6 mL/100mL 36800-179_295bf4b1-908b-4f3a-8c15-14527716af44 36800-179 HUMAN OTC DRUG topcare antacid calcium Calcium carbonate TABLET, CHEWABLE ORAL 19930429 OTC MONOGRAPH FINAL part331 Topco Associates LLC CALCIUM CARBONATE 750 mg/1 36800-181_e856275f-9950-4e56-8f17-17cff4a05a5f 36800-181 HUMAN OTC DRUG Topcare ClearLax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 Topco Associates LLC POLYETHYLENE GLYCOL 3350 17 g/17g 36800-183_5f9f439e-4d1b-429b-9d91-b3b4329b6c1e 36800-183 HUMAN OTC DRUG Topcare Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19930422 ANDA ANDA077349 Topco Associates LLC IBUPROFEN 200 mg/1 36800-184_4fc3ce55-8ce2-487c-9623-2ccc41a990ae 36800-184 HUMAN OTC DRUG ANTIBACTERIAL FRESH PEAR TRICLOSAN SOLUTION TOPICAL 20110803 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC TRICLOSAN .46 mL/100mL 36800-185_e16ccad5-f10f-4a0b-884f-84bf6597d715 36800-185 HUMAN OTC DRUG Live Better Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 TOPCO Assoc. LLC POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 36800-186_0d0aa0e3-c7b5-4165-92e3-a65249a9d622 36800-186 HUMAN OTC DRUG Top Care Enamel Guard Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 TOPCO Assoc. LLC POTASSIUM NITRATE; SODIUM FLUORIDE 5; 1.5 g/g; g/g 36800-187_134ec8f0-a77e-4429-821d-92843da8bf32 36800-187 HUMAN OTC DRUG Menstrual Relief Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20140331 OTC MONOGRAPH NOT FINAL part343 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 36800-188_09ea59a7-267c-4e91-a671-2856b96cc2e0 36800-188 HUMAN OTC DRUG Topcare hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20130722 OTC MONOGRAPH FINAL part346 Topco Associates LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 749; 2.5 mg/100g; mg/100g; mg/100g 36800-189_d29e50bc-75fe-437e-98a5-e0446919fcd6 36800-189 HUMAN OTC DRUG Topcare Childrens All Day Allergy Cetirizine HCl LIQUID ORAL 20131223 ANDA ANDA204226 Topco Associates LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL 36800-190_70c8c382-b914-4489-8232-c607820013a3 36800-190 HUMAN OTC DRUG Bisacody Enteric Coated Bisacodyl TABLET, COATED ORAL 20130110 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) BISACODYL 5 mg/1 36800-194_c3c9ae86-f6d7-4a6c-a991-be8ef7c6adbe 36800-194 HUMAN OTC DRUG TopCare Acid Reducer Famotidine TABLET ORAL 20060928 ANDA ANDA077351 Topco Associates LLC FAMOTIDINE 20 mg/1 36800-195_d1a4c321-1dc6-4063-a653-f02d75b63fad 36800-195 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FRESH PEAR TRICLOSAN LIQUID TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC TRICLOSAN 4.6 mg/mL 36800-198_28a2a9f0-2e9d-4205-a833-6eac9df7d0b0 36800-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130430 ANDA ANDA078682 TOP CARE (Topco Associates LLC) IBUPROFEN 200 mg/1 36800-199_8138de63-c7e9-4b2c-a0e2-c62292a0b320 36800-199 HUMAN OTC DRUG topcare miconazole 1 Miconazole nitrate KIT 20100617 ANDA ANDA079114 Topco Associates LLC 36800-200_0d72d72a-3ed7-4ef6-ae50-f1f9d4168088 36800-200 HUMAN OTC DRUG Topcare ZZZ Sleep Diphenhydramine HCl SOLUTION ORAL 20130820 OTC MONOGRAPH FINAL part338 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 36800-202_a1c4fa27-c787-4620-b33c-35dcdafc5c89 36800-202 HUMAN OTC DRUG topcare childrens pain and fever Acetaminophen SUSPENSION ORAL 19900115 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL 36800-205_4f439074-e7ce-4494-b33e-e9eaeb0a2698 36800-205 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20051227 OTC MONOGRAPH FINAL part358H Topco Associates LLC COAL TAR 25 mg/mL 36800-206_808a3bb2-ad5a-46b8-b5c0-ec9a4811e6f2 36800-206 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050422 ANDA ANDA078325 Topco Associates LLC NICOTINE 2 mg/1 36800-209_7a0fa0a1-106d-443f-916b-21960fe63608 36800-209 HUMAN OTC DRUG Topco Radiant White Fluoride PASTE, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part355 Topco SODIUM MONOFLUOROPHOSPHATE .76 g/100g 36800-210_66b80104-a39e-445c-9a6d-dc586902b871 36800-210 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL MOUTHWASH ORAL 19920720 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 36800-211_8878060d-c127-4f04-b48a-5e12a64cdd49 36800-211 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20130430 NDA NDA022429 TOP CARE (Topco Associates LLC) CETIRIZINE HYDROCHLORIDE 10 mg/1 36800-212_98de15d4-77a5-4ab6-af79-9a93e0115afc 36800-212 HUMAN OTC DRUG Topcare childrens allergy relief 24 hour non drowsy Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20050302 ANDA ANDA075990 Topco Associates LLC LORATADINE 10 mg/1 36800-213_60a96147-7d21-408f-bca8-c64428a4d872 36800-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20031020 OTC MONOGRAPH FINAL part355 Topco Associates, LLC SODIUM FLUORIDE .05 kg/100L 36800-214_128da2e7-80e9-43d1-a46e-09f8d641a21d 36800-214 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090515 OTC MONOGRAPH NOT FINAL part356 TOP CARE (Topco Associates LLC) HYDROGEN PEROXIDE 2.65 mL/100mL 36800-215_0b934114-6056-4f6f-ba19-4b87333588f5 36800-215 HUMAN OTC DRUG Topcare DayTime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20090901 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 36800-216_2901e605-82dd-4f1f-bb7a-ff9475e654f4 36800-216 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20130430 ANDA ANDA079174 TOP CARE (Topco Associates LLC) IBUPROFEN 200 mg/1 36800-217_f8be8f6d-652b-4410-940e-c788b73eb07a 36800-217 HUMAN OTC DRUG Topcare 8 Hour Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051129 ANDA ANDA075077 Topco Associates LLC ACETAMINOPHEN 650 mg/1 36800-218_1c26f1e8-0117-43be-8002-dea586865f8e 36800-218 HUMAN OTC DRUG Clear Anti Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 20090603 OTC MONOGRAPH FINAL part347 TOPCO ASSOCIATES PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL 36800-223_0266fdf3-1f38-4806-a8d1-8817e6f54a82 36800-223 HUMAN OTC DRUG Alcohol Free Antiseptic Oral Cetylpyridiium chloride RINSE ORAL 19900215 OTC MONOGRAPH NOT FINAL part356 Topco Associates LLC CETYLPYRIDINIUM CHLORIDE .07 mL/100L 36800-224_089d6922-8355-4bec-b453-c09d7c0a028f 36800-224 HUMAN OTC DRUG topcare anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030226 ANDA ANDA075232 Topco Associates LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 36800-225_f8736e77-0c0d-4125-b166-45285870916c 36800-225 HUMAN OTC DRUG topcare allergy relief 4 hour Chlorpheniramine Maleate TABLET ORAL 19951006 OTC MONOGRAPH FINAL part341 Topco Associates LLC CHLORPHENIRAMINE MALEATE 4 mg/1 36800-227_bfa0a1d3-8ed8-4d3e-b033-9630bff93361 36800-227 HUMAN OTC DRUG Topcare Pain Relief Acetaminophen TABLET, COATED ORAL 20060414 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 500 mg/1 36800-228_c9d94bfa-83e7-4f7a-b8c3-f74addd652ee 36800-228 HUMAN OTC DRUG Topco Arthritis 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Topco Associates LLC ACETAMINOPHEN 650 mg/1 36800-229_de2f2788-c0e6-4e6d-be1f-7483f718bbd6 36800-229 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130331 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 36800-230_7241f0c7-d2d7-40c8-9202-c570744aab22 36800-230 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20130531 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 36800-231_b27e7eff-8fd5-47e1-bdb8-3ff137ff1e8c 36800-231 HUMAN OTC DRUG TOPCARE 2 IN 1 DANDRUFF GREEN APPLE PYRITHIONE ZINC LIQUID TOPICAL 20140727 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC PYRITHIONE ZINC 10 mg/mL 36800-232_b384db7b-1f43-4971-8bdc-452a320c8d39 36800-232 HUMAN OTC DRUG TOPCARE GENTLE DANDRUFF FRESH MINT PYRITHIONE ZINC LIQUID TOPICAL 20140724 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC PYRITHIONE ZINC 10 mg/mL 36800-234_d009e4e7-919c-48a0-b5cd-c035106ca836 36800-234 HUMAN OTC DRUG Topcare Cold Head Congestion Severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20080131 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 36800-235_81900a03-9392-4236-91e8-c07fc237eadc 36800-235 HUMAN OTC DRUG TOPCARE HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20111120 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 62 mL/100mL 36800-236_2eccdd14-47c2-4b11-ab03-810a0ad42e97 36800-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 36800-238_b47dc2ab-e2ac-48c1-9458-0f5c779d9153 36800-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM 100 mg/1 36800-240_081f4359-b07d-4a39-8f58-b48635c066f8 36800-240 HUMAN OTC DRUG FOAMING HAND SANITIZER BENZALKONIUM CHLORIDE GEL TOPICAL 20110623 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE .1 mL/100mL 36800-242_0d60f9f4-9e6a-4e97-a45f-5a3eae155bbb 36800-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH FINAL part347 TOP CARE (Topco Associates LLC) DIMETHICONE 125 mg/1 36800-244_9b26e69e-dccf-4dce-960a-61a127a951ad 36800-244 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Topco Associates LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 36800-245_9f155f38-428b-4fa1-8cb1-2924f82b61f8 36800-245 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20140228 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) SENNOSIDES 25 mg/1 36800-247_26a42664-6620-4a5c-8d60-63ee3783df11 36800-247 HUMAN OTC DRUG Healing Petrolatum OINTMENT TOPICAL 20131101 OTC MONOGRAPH FINAL part347 Topco Associates LLC PETROLATUM 340 g/g 36800-248_cde6129e-eb0e-4fb4-96e3-55f51ebb2830 36800-248 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20140228 ANDA ANDA079174 TOP CARE (Topco Associates LLC) IBUPROFEN 200 mg/1 36800-249_a8058add-c494-4cc5-a955-5a6046a2248d 36800-249 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20140430 ANDA ANDA079174 TOP CARE (Topco Associates LLC) IBUPROFEN 200 mg/1 36800-253_20202aed-c9b3-4431-834d-612d65c3a9e6 36800-253 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20100202 OTC MONOGRAPH NOT FINAL part333 Topco Associates llc ALCOHOL 65 mL/100mL 36800-254_7c0bfa96-d932-46ac-a7fb-70a11e1c7d5d 36800-254 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH ALOE ETHYL ALCOHOL GEL TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 TOPCO ASSOCIATES LLC ALCOHOL 65 mL/100mL 36800-255_7709329e-fb22-4285-8d6c-9aec8b6d025f 36800-255 HUMAN OTC DRUG Topcare Ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20040910 ANDA ANDA075217 Topco Associates LLC IBUPROFEN 50 mg/1.25mL 36800-256_8b94128e-15d1-4840-950f-0ffabf79e6c1 36800-256 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140630 ANDA ANDA091353 TOP CARE (Topco Associates LLC) NAPROXEN SODIUM 220 mg/1 36800-258_0d60facb-3cc0-4f52-b32a-b5a36d1ffe0e 36800-258 HUMAN OTC DRUG TOPCARE CITRUS ESCAPE ETHYL ALCOHOL LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 620 mg/mL 36800-258_4ae4a096-0e9c-4880-a1c6-5b322bc4a726 36800-258 HUMAN OTC DRUG TOPCARE CITRUS ESCAPE ETHYL ALCOHOL LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 620 mg/mL 36800-259_bdfb8978-c377-4130-a142-014b25534b49 36800-259 HUMAN OTC DRUG Topcare Aspirin Aspirin TABLET, CHEWABLE ORAL 20060428 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ASPIRIN 81 mg/1 36800-262_aa37fc79-7e8f-4a6e-b41d-00f8d2636325 36800-262 HUMAN OTC DRUG TOPCARE APPLE POMEGRANATE ETHYL ALCOHOL LIQUID TOPICAL 20130318 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 620 mg/mL 36800-262_bff8e675-ffe9-44c1-8256-fdcc07afe08c 36800-262 HUMAN OTC DRUG TOPCARE APPLE POMEGRANATE ETHYL ALCOHOL LIQUID TOPICAL 20130318 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 620 mg/mL 36800-265_145d0b56-9b53-4cd0-a43d-4dd9df9cd7d8 36800-265 HUMAN OTC DRUG Topcare Mucus Relief Cold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130627 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 36800-266_3cc83690-405f-448e-8994-61b467b88896 36800-266 HUMAN OTC DRUG TOPCARE JASMINE TEA AND BASIL ETHYL ALCOHOL LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 620 mg/mL 36800-266_fdb1bd27-861c-4295-b0af-a2f973afd148 36800-266 HUMAN OTC DRUG TOPCARE JASMINE TEA AND BASIL ETHYL ALCOHOL LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 620 mg/mL 36800-271_bf58e257-c42b-45f3-b78a-4df2ba7a962e 36800-271 HUMAN OTC DRUG TopCare Heartburn Relief Ranitidine TABLET ORAL 20090611 ANDA ANDA076760 Topco Associates LLC RANITIDINE HYDROCHLORIDE 75 mg/1 36800-272_5907d607-e236-4847-8e4c-c5a7652a7d8d 36800-272 HUMAN OTC DRUG Topcare Sinus Congestion and Pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20070112 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 36800-273_fec63ff9-aa04-444b-a6f6-222ef296db7a 36800-273 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FOAMING WHITE TEA BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE 1.3 mg/mL 36800-274_d570642f-350b-43f0-b9ad-e59b4aeef0d7 36800-274 HUMAN OTC DRUG Topcare Aspirin Aspirin TABLET, CHEWABLE ORAL 20050329 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ASPIRIN 81 mg/1 36800-275_f08ed844-30e9-45ab-be1d-886034b61de1 36800-275 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A TOP CARE (Topco Associates LLC) ISOPROPYL ALCOHOL 70 mL/100mL 36800-276_f95d017b-82b3-4421-a6ff-fac70ded70ff 36800-276 HUMAN OTC DRUG Isopropyl Alcohol 70 Percent Isopropyl Alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A TOP CARE (Topco Associates LLC) ISOPROPYL ALCOHOL 70 mL/100mL 36800-277_7b0670e6-62a5-4b4c-a0c8-7c4ba50054fc 36800-277 HUMAN OTC DRUG TopCare Aspirin Aspirin TABLET, FILM COATED ORAL 20050503 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ASPIRIN 81 mg/1 36800-279_c334cab7-7d2d-444c-b061-13f93829ff2a 36800-279 HUMAN OTC DRUG topcare hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141103 OTC MONOGRAPH FINAL part346 Topco Associates LLC COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 36800-281_4b23a69e-c40e-4163-8f0d-3545968def27 36800-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20020528 OTC MONOGRAPH FINAL part358H Topco Associates LLC PYRITHIONE ZINC 1 kg/100L 36800-282_18892e40-e033-43c9-9645-b49b4b42cb75 36800-282 HUMAN OTC DRUG Topcare Dayhist Allergy Clemastine fumarate TABLET ORAL 19960723 ANDA ANDA074512 Topco Associates LLC CLEMASTINE FUMARATE 1.34 mg/1 36800-285_f6fd8623-f4d7-44a8-9003-9c7e2b51d51e 36800-285 HUMAN OTC DRUG Top Care Brilliant White Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 TOPCO Assoc. LLC SODIUM FLUORIDE .243 g/100g 36800-288_eba88636-eee1-488a-8c87-90ca080936b1 36800-288 HUMAN OTC DRUG Topcare Mucus Relief Guaifenesin LIQUID ORAL 20071101 OTC MONOGRAPH FINAL part341 Topco Associates LLC GUAIFENESIN 100 mg/5mL 36800-289_6cccf326-0007-4b20-afed-538e7534f297 36800-289 HUMAN OTC DRUG Topcare Infants Pain Relief Acetaminophen SUSPENSION/ DROPS ORAL 19940113 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 80 mg/.8mL 36800-296_4016faaa-2115-4f5f-8ebc-4bf6df688cd0 36800-296 HUMAN OTC DRUG topcare tussin cf max dextromethorphan hbr, guaifenesin, phenylephrine hcl SUSPENSION ORAL 20120808 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL 36800-299_1a91bb05-fd17-4c4e-924c-8bb5c27a57f2 36800-299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 19930803 OTC MONOGRAPH NOT FINAL part356 Topco Associates LLC CETYLPYRIDINIUM CHLORIDE .07 kg/100L 36800-300_f9fcd2ac-95bd-4ca6-8ade-337dd0bb7eb9 36800-300 HUMAN OTC DRUG Topcare Tussin Cough Long Acting Dextromethorphan Hydrobromide SOLUTION ORAL 19921021 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL 36800-302_6f2b0f28-2edd-4e2e-8cfc-fde3473ab4c0 36800-302 HUMAN OTC DRUG Topcare stomach relief original strength Bismuth subsalicylate SUSPENSION ORAL 19890115 OTC MONOGRAPH FINAL part335 Topco Associates LLC BISMUTH SUBSALICYLATE 525 mg/30mL 36800-304_b601db25-a0fb-440d-88ab-8e860146eb11 36800-304 HUMAN OTC DRUG Topcare Nasal oxymetazoline hydrochloride SPRAY NASAL 19891215 OTC MONOGRAPH FINAL part341 Topco Associates LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 36800-306_afd92ccc-19b8-4aec-8e5b-ae1e6b890b32 36800-306 HUMAN OTC DRUG Topcare ClearLax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 Topco Associates LLC POLYETHYLENE GLYCOL 3350 17 g/17g 36800-308_ba6c380d-94b7-4051-8cc7-293eed4554ac 36800-308 HUMAN OTC DRUG Topcare Cold Multi Symptom Severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20090622 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 36800-309_8ac0cbdc-ad65-496a-a391-77fbd7384dfd 36800-309 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20110210 OTC MONOGRAPH FINAL part358H Topco Associates PYRITHIONE ZINC 1 g/100mL 36800-310_be4ece05-a5df-41f6-8378-d1257cd794a8 36800-310 HUMAN OTC DRUG Topcare Tussin Chest Congestion Guaifenesin SYRUP ORAL 19900115 OTC MONOGRAPH FINAL part341 Topco Associates LLC GUAIFENESIN 100 mg/5mL 36800-311_0e689e73-c677-4fac-bc85-b2865fef2664 36800-311 HUMAN OTC DRUG Topcare Allergy Relief Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20040203 ANDA ANDA075990 Topco Associates LLC LORATADINE 10 mg/1 36800-318_7153bb12-c97e-46e8-83e3-ee919d9df9c9 36800-318 HUMAN OTC DRUG Original Antiseptic EUCALYPTOL MOUTHWASH ORAL 19900715 OTC MONOGRAPH NOT FINAL part356 Topco Associates, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 36800-321_ead7aec1-b706-4efd-9510-f6f5db2c6266 36800-321 HUMAN OTC DRUG Topcare Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080805 ANDA ANDA077355 Topco Associates LLC CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 36800-323_c2f2a3f5-dacc-43f6-a4ee-8a5dc93476da 36800-323 HUMAN OTC DRUG Topcare Lubricating Plus carboxymethylcellulose sodium SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130820 OTC MONOGRAPH FINAL part349 Topco Associates LLC CARBOXYMETHYLCELLULOSE SODIUM .5 g/100mL 36800-326_74892da6-bc3b-4f3b-bcb4-a54bcb1a3ddd 36800-326 HUMAN OTC DRUG Topcare Daily Facial Avobenzone, Octocrylene CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Topco Associates LLC AVOBENZONE; OCTOCRYLENE 3; 10 mL/100mL; mL/100mL 36800-328_ec7afefc-9b63-43b5-9479-13c0af093224 36800-328 HUMAN OTC DRUG Topcare Sore Throat Phenol SPRAY ORAL 19921117 OTC MONOGRAPH NOT FINAL part356 Topco Associates LLC PHENOL 1.4 g/100mL 36800-330_4c741224-23c3-4403-9eb3-b35041761231 36800-330 HUMAN OTC DRUG TOPCARE MEDICATED WIPES WITCH HAZEL CLOTH TOPICAL 20120301 OTC MONOGRAPH FINAL part346 TOPCO ASSOCIATES LLC WITCH HAZEL .5 mL/mL 36800-332_0c1823ed-f2d1-4f5b-96dc-a34526e43516 36800-332 HUMAN OTC DRUG Topcare Milk of Magnesia Magnesium hydroxide LIQUID ORAL 19930113 OTC MONOGRAPH NOT FINAL part334 Topco Associates LLC MAGNESIUM HYDROXIDE 1200 mg/15mL 36800-333_3ec63c53-688a-4968-adb0-0bbee8dd243f 36800-333 HUMAN OTC DRUG TOPCARE GENTLE DANDRUFF GREEN APPLE PYRITHIONE ZINC LIQUID TOPICAL 20140727 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC PYRITHIONE ZINC 10 mg/mL 36800-335_ce4dd998-f11d-4f61-8f2e-6dc5d610a91b 36800-335 HUMAN OTC DRUG topcare nite time cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110818 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 36800-337_eadaeb32-2ef4-46db-a0e3-c9992d457316 36800-337 HUMAN OTC DRUG Topcare Stomach Relief Bismuth subsalicylate LIQUID ORAL 19891215 OTC MONOGRAPH FINAL part335 Topco Associates LLC BISMUTH SUBSALICYLATE 1050 mg/30mL 36800-339_e942c2f6-3b5d-4d49-9a0c-97815692c8d8 36800-339 HUMAN OTC DRUG Illuminating Daily Moisturizer Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 Topco Associates LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 mL/100mL; mL/100mL; mL/100mL 36800-340_179e7d65-7e98-437e-9174-62cfc4ebef89 36800-340 HUMAN OTC DRUG Topcare Antacid Plus Anti Gas aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 19900715 OTC MONOGRAPH FINAL part331 Topco Associates LLC ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 36800-343_889d65ef-dfdc-4e8b-884e-83b60518e467 36800-343 HUMAN OTC DRUG Topcare Sore Throat Phenol SPRAY ORAL 19930119 OTC MONOGRAPH NOT FINAL part356 Topco Associates LLC PHENOL 1.4 mL/100mL 36800-344_5814bdc4-49ef-4f1c-a0e0-83698df59de0 36800-344 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex LOZENGE ORAL 20090903 ANDA ANDA077007 Topco Associates LLC NICOTINE 2 mg/1 36800-345_2b384fbd-4a54-4c5f-9cc5-0e28b79658d0 36800-345 HUMAN OTC DRUG topcare severe sinus congestion Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140622 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 36800-352_8006d785-1a63-4577-8175-b878a6cc0c7e 36800-352 HUMAN OTC DRUG Topcare nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20100128 ANDA ANDA078547 Topco Associates LLC NICOTINE 2 mg/1 36800-353_7511c32a-6437-4f60-9b1d-ea2e963ad07f 36800-353 HUMAN OTC DRUG bleve bvibrant Octyl Methoxycinnamate LOTION TOPICAL 20120319 OTC MONOGRAPH NOT FINAL part352 TOPCO ASSOCIATES LLC AVOBENZONE; OCTINOXATE .5; 2 mL/100mL; mL/100mL 36800-355_b2c605f6-2b6b-4dab-af13-e35705ef09d0 36800-355 HUMAN OTC DRUG Topcare Headache PM Formula Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19970825 OTC MONOGRAPH FINAL part338 Topco Associates LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 36800-357_24963b4e-50c8-4b06-b964-0969576168bd 36800-357 HUMAN OTC DRUG Topcare Antacid Regular Strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19900815 OTC MONOGRAPH FINAL part331 Topco Associates LLC ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 36800-358_4f686dfa-ce45-4c37-afad-d14ee9648882 36800-358 HUMAN OTC DRUG TopCare Sinus and Allergy PE Maximum Strength Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20060929 OTC MONOGRAPH FINAL part341 Topco Associates LLC CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 36800-359_f5b26954-31a0-4397-a45e-426b3b042142 36800-359 HUMAN OTC DRUG Topcare Tussin DM Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 19910814 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 36800-360_611d64de-86da-4807-a1a0-f0eb7a6d43bf 36800-360 HUMAN OTC DRUG Long-Lasting Oil-Free Moisturizer Avobenzone, Octisalate, Octocrylene and Oxybenzone CREAM TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 Topco Associates LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 4; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL 36800-361_2c3be9c8-b4f2-43b3-9a20-0202fcf2f420 36800-361 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20121019 OTC MONOGRAPH FINAL part338 Topco Associates LLC (Top Care) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 36800-366_0c69d749-c201-4aa9-8551-464022d46553 36800-366 HUMAN OTC DRUG TOPCARE MANDARIN TRICLOSAN LIQUID TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC TRICLOSAN 6 mg/mL 36800-368_9034d2ed-9c56-4707-a731-806a925fb026 36800-368 HUMAN OTC DRUG TopCare All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 19970114 ANDA ANDA074661 Topco Associates LLC NAPROXEN SODIUM 220 mg/1 36800-370_d92943d3-2a34-4501-b667-e9376a24cae7 36800-370 HUMAN OTC DRUG Advanced Ethyl Alcohol GEL TOPICAL 20120927 OTC MONOGRAPH NOT FINAL part333A TOPCO Assoc. LLC ALCOHOL 616 mg/mL 36800-371_c0732bd0-5a49-4e8e-838f-946010fabad5 36800-371 HUMAN OTC DRUG Topcare Cold Multi Symptom Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20071009 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 36800-374_485d9196-d62f-4f9b-bbc1-d49a5d37b211 36800-374 HUMAN OTC DRUG Topcare Migraine Formula Acetaminophen, Aspirin, Caffeine TABLET ORAL 20030401 ANDA ANDA075794 Topco Associates LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 36800-375_c7151d13-724a-4f23-9dd9-a90b00f510ae 36800-375 HUMAN OTC DRUG topcare nicotine polacrilex Nicotine Polacrilex LOZENGE ORAL 19980622 ANDA ANDA090711 Topco Associates LLC NICOTINE 2 mg/1 36800-379_8a74b492-af6b-4931-b51d-b6edb9681a11 36800-379 HUMAN OTC DRUG Topcare childrens allergy Diphenhydramine Hydrochloride LIQUID ORAL 19871215 OTC MONOGRAPH FINAL part341 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 36800-381_604cbf77-d2d0-4322-ab6f-e7d61fa2d276 36800-381 HUMAN OTC DRUG TopCare Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Topco Associates LLC NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g 36800-390_e6ceb962-8355-4267-b133-2ffa77b16893 36800-390 HUMAN OTC DRUG Topcare Nose Drops Phenylephrine hydrochloride LIQUID NASAL 20080812 OTC MONOGRAPH FINAL part341 Topco Associates LLC PHENYLEPHRINE HYDROCHLORIDE 1 mL/100mL 36800-393_28702a14-bc0b-4624-9f36-fd51a6904c99 36800-393 HUMAN OTC DRUG Topcare Cold Head Congestion Nighttime Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070719 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 36800-394_f5c51668-ba24-4d4d-a526-bd881c78f21a 36800-394 HUMAN OTC DRUG Topcare Hemorrhoidal Cocoa butter, Phenylephrine HCl, Shark liver oil SUPPOSITORY RECTAL 19980416 OTC MONOGRAPH FINAL part346 Topco Associates LLC COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2137.5; 75; 6.375 mg/1; mg/1; mg/1 36800-396_8edeaef1-c840-41b8-ac5f-9db44ee9be41 36800-396 HUMAN OTC DRUG Topcare Milk of Magnesia Magnesium hydroxide LIQUID ORAL 19910910 OTC MONOGRAPH NOT FINAL part334 Topco Associates LLC MAGNESIUM HYDROXIDE 1200 mg/15mL 36800-397_e30ca405-a32c-400f-9a04-d1a55383f7bc 36800-397 HUMAN OTC DRUG Topcare pain and fever childrens acetaminophen LIQUID ORAL 20120228 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL 36800-400_2f78bec4-778e-4347-8dbd-e2eab901a29d 36800-400 HUMAN OTC DRUG topcare Hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 19951221 OTC MONOGRAPH FINAL part346 Topco Associates LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 36800-401_7a967de2-f825-4369-9f44-1b9e17ac87b6 36800-401 HUMAN OTC DRUG Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% LIQUID TOPICAL 20131101 NDA NDA019125 Topco Associates LLC CHLORHEXIDINE GLUCONATE 4 mg/100mL 36800-402_6a742c9f-6eb0-4a10-bc30-64db1da007e2 36800-402 HUMAN OTC DRUG Topcare Cold Head Congestion Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070501 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 36800-403_ac406eb8-38e1-4160-9e27-ec0fa0140d98 36800-403 HUMAN OTC DRUG Topcare Pain Relief Acetaminophen TABLET ORAL 19870715 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 325 mg/1 36800-404_5969b109-f11b-483a-9313-d64a0eeeeb50 36800-404 HUMAN OTC DRUG topcare arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070820 ANDA ANDA075077 Topco Associates LLC ACETAMINOPHEN 650 mg/1 36800-405_4e94fa6f-aca0-4d2a-83e4-cb5d8bc91535 36800-405 HUMAN OTC DRUG Topcare Pain Relief Extra Strength Acetaminophen TABLET ORAL 19870715 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 500 mg/1 36800-407_30f72640-7db4-4a0e-a685-460d9fcb99eb 36800-407 HUMAN OTC DRUG TopCare Cold Sore Treatment Camphor CREAM TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g 36800-409_085356ca-3f0f-4f1c-b203-ba2fa96a71d3 36800-409 HUMAN OTC DRUG Topcare stay awake maximum strength Caffeine TABLET ORAL 19931214 OTC MONOGRAPH FINAL part340 Topco Associates LLC CAFFEINE 200 mg/1 36800-417_55c177ce-1729-4a9b-a5ae-2b6c96fbc27a 36800-417 HUMAN OTC DRUG Topcare Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130814 ANDA ANDA076518 Topco Associates LLC NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 36800-419_d6c9d4f7-746c-49bb-87ec-92caeafe80c5 36800-419 HUMAN OTC DRUG Topcare Mucus Relief Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20071127 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 36800-422_c70ae28f-f0e9-49c6-804f-d24b34602d45 36800-422 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050426 ANDA ANDA078326 Topco Associates LLC NICOTINE 4 mg/1 36800-423_ea0fe758-a552-4b80-9e0c-95d3e8053334 36800-423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011008 ANDA ANDA074567 Topco Associates LLC IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 36800-424_1fcccdd5-4dd6-43fd-a8f3-0c32bb897587 36800-424 HUMAN OTC DRUG TOPCARE 2 IN 1 DANDRUFF EVERYDAY CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20140727 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC PYRITHIONE ZINC 10 mg/mL 36800-425_59d23a88-396b-497a-b3c3-d36da47d881d 36800-425 HUMAN OTC DRUG Topcare fexofenadine hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20110902 ANDA ANDA076447 Topco Associates LLC FEXOFENADINE HYDROCHLORIDE 60 mg/1 36800-426_fce06160-2098-4ac1-9cc3-a584d4f5a51d 36800-426 HUMAN OTC DRUG Topcare Tioconazole 1 Tioconazole OINTMENT VAGINAL 20080303 ANDA ANDA075915 Topco Associates LLC TIOCONAZOLE 6.5 g/100g 36800-427_24f2a5a6-c263-4bdd-b553-6ef52e80766c 36800-427 HUMAN OTC DRUG TOPCARE GENTLE DANDRUFF EVERYDAY CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20140727 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC PYRITHIONE ZINC 10 mg/mL 36800-427_549e24f3-0b83-42ae-a177-74c45bfaa5b2 36800-427 HUMAN OTC DRUG TOPCARE GENTLE DANDRUFF EVERYDAY CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20140724 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC PYRITHIONE ZINC 10 mg/mL 36800-428_e471a42d-3d56-41b1-a7ff-5609eae1559c 36800-428 HUMAN OTC DRUG topcare gas relief extra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20020129 OTC MONOGRAPH FINAL part332 Topco Associates LLC DIMETHICONE 125 mg/1 36800-429_70f2d090-d0e6-4aa4-a921-66e89b2eb3c9 36800-429 HUMAN OTC DRUG TOPCARE GENTLE DANDRUFF DRY SCALP PYRITHIONE ZINC LIQUID TOPICAL 20140727 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC PYRITHIONE ZINC 10 mg/mL 36800-430_74c489e8-9a35-4462-97be-ae3bc376e2fc 36800-430 HUMAN OTC DRUG topcare headache formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19990113 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 36800-431_45e20189-c1da-41bd-b02c-7e097d65f0a5 36800-431 HUMAN OTC DRUG topcare sleep aid nighttime Diphenhydramine Hydrochloride TABLET ORAL 20010911 OTC MONOGRAPH FINAL part338 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 36800-432_1a9e0336-c0c2-43f8-aeea-668d4a209714 36800-432 HUMAN OTC DRUG Topcare Nasal Decongestant Maximum Strength Non Drowsy Pseudoephedrine HCl TABLET, FILM COATED ORAL 19880115 OTC MONOGRAPH FINAL part341 Topco Associates LLC PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 36800-434_edaded7d-21d6-4a83-bf15-36b6c50787f2 36800-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130801 OTC MONOGRAPH NOT FINAL part356 TopCo Associates, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 36800-437_09015ce5-0152-49bb-9e2f-92067d10d4f8 36800-437 HUMAN OTC DRUG Topcare pain relief PM extra strength non habit forming Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19920721 OTC MONOGRAPH FINAL part338 Topco Associates LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 36800-438_4ba9bbaf-d946-4a9e-81a2-efe1d31a980b 36800-438 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20111208 OTC MONOGRAPH FINAL part338 Topco Associates LLC (Top Care) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 36800-439_b1360ac4-ca82-4ad5-8c5c-f702ffed7608 36800-439 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130530 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 36800-441_c90c6bc7-ae9e-4496-a25b-be3480d3ad79 36800-441 HUMAN OTC DRUG TopCare Sleep Aid Doxylamine succinate TABLET ORAL 19970129 ANDA ANDA040167 Topco Associates LLC DOXYLAMINE SUCCINATE 25 mg/1 36800-443_9635d527-0948-4be4-b09b-d7c3eb51122c 36800-443 HUMAN OTC DRUG Topcare Maximum Strength Benzocaine LIQUID ORAL 20141001 OTC MONOGRAPH FINAL part333B Topco BENZOCAINE 20 g/100g 36800-444_a81a0eeb-93bd-4521-93bc-dc908536995a 36800-444 HUMAN OTC DRUG Topcare Cold and Cough Dextromethorphan HBr, Phenylephrine HCl SYRUP ORAL 20070920 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 36800-445_42a6d684-9d9f-4dd0-a308-d4c6cbb2f88a 36800-445 HUMAN OTC DRUG topcare flu and severe cold and cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20140309 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 36800-453_574a5936-314d-4835-8a46-ce6631c8c7cc 36800-453 HUMAN OTC DRUG Topcare Cold and Flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20140401 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 36800-456_61ff2afe-73ab-4a81-a1c3-fccbe85cd577 36800-456 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061218 ANDA ANDA076777 Topco Associates LLC NICOTINE 2 mg/1 36800-458_8a39874c-0ec0-4aa0-908b-7f0001266825 36800-458 HUMAN OTC DRUG TopCare All Day Allergy Cetirizine Hydrochloride TABLET ORAL 20080110 ANDA ANDA078336 Topco Associates LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 36800-459_0742c049-15e0-442e-9f51-d96ac37c5350 36800-459 HUMAN OTC DRUG topcare nite time cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110819 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 36800-461_157b0702-5e3a-4d1f-88fe-a0c0e60a5806 36800-461 HUMAN OTC DRUG Topcare Ibuprofen Junior Strength Ibuprofen TABLET, CHEWABLE ORAL 20040528 ANDA ANDA076359 Topco Associates LLC IBUPROFEN 100 mg/1 36800-462_58d1204c-1374-48a9-bd34-ba5b2383433e 36800-462 HUMAN OTC DRUG Topcare Allergy diphenhydramine hydrochloride CAPSULE ORAL 19880115 OTC MONOGRAPH FINAL part341 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 36800-463_f4bd7274-cd8f-4a99-9547-a654cfd4ea3f 36800-463 HUMAN OTC DRUG Topcare Allergy Chlorpheniramine Maleate TABLET ORAL 19951006 OTC MONOGRAPH FINAL part341 Topco Associates LLC CHLORPHENIRAMINE MALEATE 4 mg/1 36800-464_8350d60a-c052-4ce7-a522-53d34bb413eb 36800-464 HUMAN OTC DRUG TOPCARE COCONUT CREAM ETHYL ALCOHOL LIQUID TOPICAL 20120319 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 620 mg/mL 36800-464_f0184a86-e618-4b5b-9d74-77b6bb86165c 36800-464 HUMAN OTC DRUG TOPCARE COCONUT CREAM ETHYL ALCOHOL LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 620 mg/mL 36800-467_f0e07f95-54fa-4b47-a041-bed96d816439 36800-467 HUMAN OTC DRUG Topcare Aspirin Aspirin TABLET, CHEWABLE ORAL 19920824 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ASPIRIN 81 mg/1 36800-468_a607b1e9-2553-40e0-b06e-0e230d836b44 36800-468 HUMAN OTC DRUG topcare antacid calcium Calcium carbonate TABLET, CHEWABLE ORAL 19970729 OTC MONOGRAPH FINAL part331 Topco Associates LLC CALCIUM CARBONATE 750 mg/1 36800-469_2a5afa1f-51a2-4f99-adbd-8db6bd30e82c 36800-469 HUMAN OTC DRUG Topcare Stomach Relief Original Strength Bismuth subsalicylate TABLET, CHEWABLE ORAL 19910917 OTC MONOGRAPH FINAL part335 Topco Associates LLC BISMUTH SUBSALICYLATE 262 mg/1 36800-473_238cf987-d67a-4d1f-9eac-3d67916a79b9 36800-473 HUMAN OTC DRUG TopCare Day Time Cough Dextromethorphan HBr LIQUID ORAL 20071127 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE 15 mg/15mL 36800-476_84343d8f-5ef9-48ba-ab9e-2d7b8eca4328 36800-476 HUMAN OTC DRUG Topcare Allergy Multi Symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20051209 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 36800-477_4f9cb525-7c2c-49c8-987b-bc54638cb15d 36800-477 HUMAN OTC DRUG Topcare Fiber Laxative Calcium polycarbophil TABLET, FILM COATED ORAL 19970811 OTC MONOGRAPH NOT FINAL part334 Topco Associates LLC CALCIUM POLYCARBOPHIL 625 mg/1 36800-478_54b357d9-ced7-4995-8541-ff18d6818153 36800-478 HUMAN OTC DRUG topcare antacid calcium calcium carbonate TABLET, CHEWABLE ORAL 19940713 OTC MONOGRAPH FINAL part331 Topco Associates LLC CALCIUM CARBONATE 500 mg/1 36800-479_fe2dcf69-fc4b-4e49-a9e4-3d9642b5f992 36800-479 HUMAN OTC DRUG Topcare Allergy Diphenhydramine Hydrochloride TABLET ORAL 19931214 OTC MONOGRAPH FINAL part341 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 36800-481_8878c78d-128e-429b-868d-4364f9fcb364 36800-481 HUMAN OTC DRUG Topco Associates LLC Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Topco Associates LLC POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 36800-482_878cf349-cef3-454a-9ed4-c817f4e58dbd 36800-482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20130919 OTC MONOGRAPH FINAL part355 TOPCO Associates LLC SODIUM FLUORIDE .219 mg/mL 36800-484_deb1c8c7-c206-4d3a-9309-ebac58eb3912 36800-484 HUMAN OTC DRUG Topcare Pain Relief Acetaminophen TABLET ORAL 19870715 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 500 mg/1 36800-485_08e596ab-ac91-4720-9f77-fabbbd3d554c 36800-485 HUMAN OTC DRUG TopCare Antacid Calcium Regular Strength calcium carbonate TABLET, CHEWABLE ORAL 19910910 OTC MONOGRAPH FINAL part331 Topco Associates LLC CALCIUM CARBONATE 500 mg/1 36800-486_19ae3f0b-5d5a-44fd-a546-7040de85505f 36800-486 HUMAN OTC DRUG Topcare Stool Softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 19940126 OTC MONOGRAPH NOT FINAL part334 Topco Associates LLC DOCUSATE SODIUM 100 mg/1 36800-489_022829b9-634b-4d0e-994b-1afc461d766a 36800-489 HUMAN OTC DRUG Topcare Antacid Calcium Extra Strength Calcium carbonate TABLET, CHEWABLE ORAL 20010403 OTC MONOGRAPH FINAL part331 Topco Associates LLC CALCIUM CARBONATE 750 mg/1 36800-490_e88d6177-799c-4f02-8e7c-f63df70f12ab 36800-490 HUMAN OTC DRUG Topcare All Day Pain Relief Naproxen Sodium TABLET ORAL 19970114 ANDA ANDA074661 Topco Associates LLC NAPROXEN SODIUM 220 mg/1 36800-495_5ea9c208-ef94-4854-89d9-a4b72acf51ca 36800-495 HUMAN OTC DRUG TopCare Antifungal Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Topco Associates LLC CLOTRIMAZOLE 10 mg/g 36800-496_c0947725-f211-4e23-8df4-b4b0396a1167 36800-496 HUMAN OTC DRUG topcare cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20080118 OTC MONOGRAPH FINAL part341 Topco Associates LLC 36800-498_28309d8a-07c0-42c9-bc71-647d5b615db8 36800-498 HUMAN OTC DRUG Topcare mucus er Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130318 ANDA ANDA078912 Topco Associates LLC GUAIFENESIN 600 mg/1 36800-499_615e87e4-79e0-44d6-b563-3bcd5a9b2d93 36800-499 HUMAN OTC DRUG topcare hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140328 OTC MONOGRAPH FINAL part346 Topco Associates LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 36800-503_a26f9ed4-f862-4187-861d-df7423d09ab1 36800-503 HUMAN OTC DRUG Topcare Day time cold and flu relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20110317 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 36800-506_2cd8c13a-d8c7-4012-8e8d-38f429435e68 36800-506 HUMAN OTC DRUG TopCare Anti-Itch Diphenhydramine Hydrochloride and Zinc Acetate CREAM TOPICAL 20050920 OTC MONOGRAPH FINAL part348 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g 36800-507_3361c217-f02e-4ab6-94af-ba54ff1adf58 36800-507 HUMAN OTC DRUG Topcare ZZZ Sleep Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140128 OTC MONOGRAPH FINAL part338 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 36800-515_48af4577-ca43-4f7f-bedf-62c0c6b7e64f 36800-515 HUMAN OTC DRUG topcare tussin mucus plus chest congestion Guaifenesin SYRUP ORAL 19900115 OTC MONOGRAPH FINAL part341 Topco Associates LLC GUAIFENESIN 200 mg/10mL 36800-516_943b1bdf-5598-4d9e-88e0-062560a2511d 36800-516 HUMAN OTC DRUG topcare tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 19920715 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 36800-517_4dd18af5-dfc7-49d5-9ca5-86ab57f940ef 36800-517 HUMAN OTC DRUG Topcare ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060428 ANDA ANDA077349 Topco Associates LLC IBUPROFEN 200 mg/1 36800-519_8f4bf0a6-cbf2-4ea6-90ff-2fa01528a6f9 36800-519 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 19901115 OTC MONOGRAPH FINAL part347 Topco Associates, LLC PETROLATUM 1 g/g 36800-520_389f807b-f399-4863-aa27-0995e4544b88 36800-520 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100716 NDA NDA021855 TOP CARE (Topco Associates LLC) LOPERAMIDE HYDROCHLORIDE 2 mg/1 36800-522_707ca4e7-0553-4eaa-b99e-081387d4f375 36800-522 HUMAN OTC DRUG topcare day time cold and flu relief multi symptom relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20060717 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 36800-523_58016873-1692-4489-bcef-257c5a8e462d 36800-523 HUMAN OTC DRUG TopCare Daily Moisturizer for face avobenzone, octinoxate,octisalate LOTION TOPICAL 20090622 OTC MONOGRAPH NOT FINAL part352 Topco Associates LLC AVOBENZONE; OCTINOXATE; OCTISALATE 3.6; 9; 2.4 mL/120mL; mL/120mL; mL/120mL 36800-527_7d515ff3-fb50-4129-8d0f-cde4336c7327 36800-527 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Topcare Associates LLC LORATADINE 10 mg/1 36800-528_dc5acc2d-e646-4db3-97f2-77e16b4b34ef 36800-528 HUMAN OTC DRUG Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Topco Associates LLC LORATADINE 10 mg/1 36800-532_b78bfd28-4b5b-45f5-8418-1c7365383113 36800-532 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061030 ANDA ANDA076779 Topco Associates LLC NICOTINE 4 mg/1 36800-538_90e36675-659b-4522-96c4-a6277a01252b 36800-538 HUMAN OTC DRUG TopCare Allergy Relief D Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20030620 ANDA ANDA075706 Topco Associates LLC LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 36800-539_de0e31dc-22da-4cf4-8643-08081f0834e1 36800-539 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex LOZENGE ORAL 20130212 ANDA ANDA090711 Topco Associates LLC NICOTINE 4 mg/1 36800-540_24ff6c4a-adc0-4e85-837b-b84398d2b133 36800-540 HUMAN OTC DRUG TopCare Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20140318 OTC MONOGRAPH FINAL part341 TOPCARE (Topco Associates LLC) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 36800-544_83171f34-442e-4bea-91d2-7c276492ebaa 36800-544 HUMAN OTC DRUG Topcare Arthritis Pain Relief Temporary Minor Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050804 ANDA ANDA075077 Topco Associates LLC ACETAMINOPHEN 650 mg/1 36800-546_330f680a-11e2-422c-82ea-376eacf04457 36800-546 HUMAN OTC DRUG TopCare Complete acid reducer plus antacid Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080805 ANDA ANDA077355 Topco Associates LLC CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 36800-548_5bc16bdf-946b-4899-9050-ca5fdefd9505 36800-548 HUMAN OTC DRUG topcare day time cold and flu severe acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140622 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 36800-550_103a99d1-3a27-46dd-9a00-7333e9689e5b 36800-550 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20130531 OTC MONOGRAPH FINAL part347 TOP CARE (Topco Associates LLC) DIMETHICONE 125 mg/1 36800-552_fd2af7a4-4388-4792-b720-7955e44ef0c4 36800-552 HUMAN OTC DRUG Topcare Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120830 ANDA ANDA091135 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 36800-557_03036276-74a9-4e37-8cc7-3dc0f0f23e69 36800-557 HUMAN OTC DRUG Topcare Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 19931214 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL 36800-567_02388976-4599-41ee-a0d6-f0a439af50f7 36800-567 HUMAN OTC DRUG topcare day time nite time cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120807 OTC MONOGRAPH FINAL part341 Topco Associates LLC 36800-567_66c9e090-4e53-4e30-9655-5f6261caade9 36800-567 HUMAN OTC DRUG Topcare Day Time Nite Time Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20111107 OTC MONOGRAPH FINAL part341 Topco Associates LLC 36800-571_d8d2283d-a71b-4262-aa61-ee6baeaefb0b 36800-571 HUMAN OTC DRUG topcare fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Topco Associates LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 36800-578_7d96884f-97e9-4716-8c10-5d00d2ee6b60 36800-578 HUMAN OTC DRUG Topcare tussin dm sugar free cough and chest congestion Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19950404 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 36800-579_72a33640-ca7f-460d-9357-772d5bf56bac 36800-579 HUMAN OTC DRUG topcare fever reducer Acetaminophen SUPPOSITORY RECTAL 20110926 ANDA ANDA070607 Topco Associates LLC ACETAMINOPHEN 120 mg/1 36800-580_efb8e0e2-0795-4f4a-8ca6-955f33bee143 36800-580 HUMAN OTC DRUG Topcare Nite Time Day Time Cold and Flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140429 OTC MONOGRAPH FINAL part341 Topco Associates LLC 36800-588_62bebd68-6484-4524-a01d-c66d369c5403 36800-588 HUMAN OTC DRUG Topcare Antacid Maximum Strength Aluminum Hydroxide, Magnesium Hydroxide, Simethicone LIQUID ORAL 20060428 OTC MONOGRAPH FINAL part332 Topco Associates LLC ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 36800-590_f129bc0e-1ef1-42a8-8668-2ee88ffc85e3 36800-590 HUMAN OTC DRUG topcare infants pain and fever acetaminophen LIQUID ORAL 19930721 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL 36800-595_cecac840-306f-48b7-a809-7af566b22c56 36800-595 HUMAN OTC DRUG topcare Antacid Calcium Ultra Strength Calcium Carbonate TABLET, CHEWABLE ORAL 20020212 OTC MONOGRAPH FINAL part331 Topco Associates LLC CALCIUM CARBONATE 1000 mg/1 36800-597_aed387e0-5a8b-4caf-a373-3e04496a4983 36800-597 HUMAN OTC DRUG Topcare Day Time Nite Time Cold and Flu acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140628 OTC MONOGRAPH FINAL part341 Topco Associates LLC 36800-602_d4bfad7f-3211-4068-a999-a653f1fc2900 36800-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 19990715 OTC MONOGRAPH FINAL part334 TOPCO Associates, LLC MAGNESIUM SULFATE 1 g/g 36800-603_a88e5b8e-e6dd-4a1c-9628-5861d3205bdb 36800-603 HUMAN OTC DRUG Topcare Day Time Cold and Flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SUSPENSION ORAL 20140613 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 36800-604_2a44dca5-a643-4ddb-b21c-3d5eac649608 36800-604 HUMAN OTC DRUG TopCare Ibuprofen Ibuprofen TABLET ORAL 19880215 ANDA ANDA072096 Topco Associates LLC IBUPROFEN 200 mg/1 36800-609_864c5283-5822-49ff-a145-be1b1e1c49c0 36800-609 HUMAN OTC DRUG Topcare Nite Time D Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID ORAL 19891215 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 500; 15; 6.25; 30 mg/15mL; mg/15mL; mg/15mL; mg/15mL 36800-610_d3eb067c-e627-4368-86c4-3390047d5bfa 36800-610 HUMAN OTC DRUG TopCare MEDICATED DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20100929 OTC MONOGRAPH FINAL part358H Topco Associates LLC SELENIUM SULFIDE 1 mL/100mL 36800-612_43a82ee1-2d06-4368-8ff7-60da5d62480f 36800-612 HUMAN OTC DRUG TopCare Allergy Relief 24 hour Loratadine TABLET ORAL 20050125 ANDA ANDA076301 Topco Associates LLC LORATADINE 10 mg/1 36800-618_518763f2-eeb4-48e9-b869-bedc4645a175 36800-618 HUMAN OTC DRUG TOPCARE GENTLE DANDRUFF CLINICAL STRENGTH SELENIUM SULFIDE LIQUID TOPICAL 20140728 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC SELENIUM SULFIDE 10 mg/mL 36800-619_c1208234-3bb5-4967-aa7d-61053e954ce6 36800-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20100903 OTC MONOGRAPH FINAL part347 TopCo Associates LLC DIMETHICONE 13.13 mg/mL 36800-620_fc1fcb2f-03da-41d3-96cb-4a8d9cd7ff83 36800-620 HUMAN OTC DRUG Motion Sickness II Meclizine HCl TABLET ORAL 20130531 OTC MONOGRAPH FINAL part336 TOP CARE (Topco Associates LLC) MECLIZINE HYDROCHLORIDE 25 mg/1 36800-630_9bc8db51-eb04-4b47-9be9-1dcc90e76201 36800-630 HUMAN OTC DRUG Motion Sickness Dimenhydrinate TABLET ORAL 20130531 OTC MONOGRAPH FINAL part336 TOP CARE (Topco Associates LLC) DIMENHYDRINATE 50 mg/1 36800-645_0b60f3c3-7643-424f-87c6-16e6a126d264 36800-645 HUMAN OTC DRUG topcare loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120605 ANDA ANDA091292 Topco Associates LLC LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 36800-647_7c60f698-536c-4e26-8890-46c3a6dcd198 36800-647 HUMAN OTC DRUG Topcare Ibuprofen Ibuprofen TABLET, COATED ORAL 19881115 ANDA ANDA072096 Topco Associates LLC IBUPROFEN 200 mg/1 36800-648_99bc8829-167b-4cf8-8421-57da369f24cd 36800-648 HUMAN OTC DRUG Topcare Nasal Four Phenylephrine hydrochloride SPRAY NASAL 20021210 OTC MONOGRAPH FINAL part341 Topco Associates LLC PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 36800-656_266d30ba-1005-45b7-8b98-828d6928ae07 36800-656 HUMAN OTC DRUG Top Care Day Time Multi Symptom Relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20060717 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 36800-660_68305c2a-741e-4ab6-a393-0f54e2ccc093 36800-660 HUMAN OTC DRUG Topcare Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20020702 ANDA ANDA074937 Topco Associates LLC IBUPROFEN 100 mg/5mL 36800-664_d6f413ba-4830-420f-80cd-80f703e51d58 36800-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19921026 OTC MONOGRAPH NOT FINAL part356 Topco Associates LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 36800-666_6fd04d08-5a57-4d55-b032-20ad0703d21b 36800-666 HUMAN OTC DRUG Topcare Cough and Sore Throat Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20060309 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 36800-668_d49cf1e8-16d0-472d-96bd-12ff80e3c0a9 36800-668 HUMAN OTC DRUG topcare nite time cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20021210 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 36800-678_63fc1ccf-74a6-4af8-b7f9-8cf46a5e9199 36800-678 HUMAN OTC DRUG Topcare hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20121207 OTC MONOGRAPH FINAL part346 Topco Associates LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 36800-679_47ad6cb1-9a6a-4fce-a076-4ac05ef393e5 36800-679 HUMAN OTC DRUG Topcare Pain Relieving 40ct Camphor Menthol Methyl Salicylate PATCH TOPICAL 20140916 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC CAMPHOR (SYNTHETIC); MENTHOL; MENTHYL SALICYLATE, (+/-)- .012; .057; .063 mg/g; mg/g; mg/g 36800-685_340e310f-f3bb-4dab-a849-464f1639a896 36800-685 HUMAN OTC DRUG Topcare ibuprofen childrens Ibuprofen LIQUID ORAL 19950203 ANDA ANDA074937 Topco Associates LLC IBUPROFEN 100 mg/5mL 36800-688_e8576482-a704-4b75-8219-c178c028b18d 36800-688 HUMAN OTC DRUG Topcare Sinus Relief Oxymetazoline HCl SPRAY NASAL 20090729 OTC MONOGRAPH FINAL part341 Topco Associates LLC OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL 36800-690_af173d6e-ed61-4856-a95d-540c3dfe55f1 36800-690 HUMAN OTC DRUG Allergy Relief Diphenhydramine Hydrochloride TABLET ORAL 20130331 OTC MONOGRAPH FINAL part336 TOP CARE (Topco Associates LLC) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 36800-693_cdfaff51-b998-4555-900b-68a6996dd547 36800-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20040709 OTC MONOGRAPH NOT FINAL part334 Topco Assoc LLC MAGNESIUM CITRATE 1.745 g/29.6mL 36800-698_1b7afe70-3151-455d-b6de-e7518b718f2f 36800-698 HUMAN OTC DRUG Topcare Cough and Sore Throat Acetaminophen, Dextromethorphan HBr LIQUID ORAL 20060310 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 500; 15 mg/15mL; mg/15mL 36800-699_39e6b41f-ee62-4e30-97b9-87e7f2a8d279 36800-699 HUMAN OTC DRUG Topcare childrens pain and fever Acetaminophen SUSPENSION ORAL 19970826 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL 36800-700_fcc7ec89-f96d-41de-9fec-e3016fdd7f33 36800-700 HUMAN OTC DRUG topcare day time Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20060928 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 36800-703_85b859ca-a480-4787-8d34-10e51159a9da 36800-703 HUMAN OTC DRUG Topcare Cold and Cough Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20060309 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 36800-719_1a4c451e-c0f9-45c9-a878-363e61169765 36800-719 HUMAN OTC DRUG TOPCARE MEDICATED DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20141117 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC SELENIUM SULFIDE 10 mg/mL 36800-720_4655de57-35e9-4c82-904d-e024ff433565 36800-720 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130530 OTC MONOGRAPH FINAL part336 TOP CARE (Topco Associates LLC) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 36800-724_71a4c639-174f-4480-91c1-033eb90b85f7 36800-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Topco Associates LLC LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 36800-733_3bed0245-c229-4e58-93f7-545d96f256fc 36800-733 HUMAN OTC DRUG Topcare Nite Time Day Time Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120815 OTC MONOGRAPH FINAL part341 Topco Associates LLC 36800-733_41723b37-836b-4aa1-b2a5-156c5b455f57 36800-733 HUMAN OTC DRUG Topcare Nite Time Day Time Cold and Flu Relief acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20111215 OTC MONOGRAPH FINAL part341 Topco Associates LLC 36800-734_dcf62b76-5192-4fa3-8bd6-d65e8cb088e8 36800-734 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex LOZENGE ORAL 20130215 ANDA ANDA203690 Topco Associates LLC NICOTINE 2 mg/1 36800-737_6185d97a-b647-4d74-bf86-237917b3fff8 36800-737 HUMAN OTC DRUG topcare miconazole 1 Miconazole nitrate KIT 20100615 ANDA ANDA079114 Topco Associates LLC 36800-742_9f6682ce-22ce-4eaa-87b6-6c1e45026304 36800-742 HUMAN OTC DRUG Topcare Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20101123 NDA NDA021920 Topco Associates LLC NAPROXEN SODIUM 220 mg/1 36800-751_c6a73b38-4039-4e30-af42-d6fd1cda271a 36800-751 HUMAN OTC DRUG topcare pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120203 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 36800-759_983b9676-1bc5-4801-a4c7-c0538e8c4d48 36800-759 HUMAN OTC DRUG topcare pain and fever Acetaminophen SUSPENSION ORAL 20100929 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL 36800-763_5daafb37-f80a-4514-be32-a52e4569a1f7 36800-763 HUMAN OTC DRUG Topcare Nite Time Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SUSPENSION ORAL 20140609 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 36800-766_2547e3a7-b060-442f-b119-f43cc0632ae9 36800-766 HUMAN OTC DRUG topcare infants pain and fever Acetaminophen SUSPENSION ORAL 20111103 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL 36800-799_186af247-631d-41c9-9a65-b56e57a96777 36800-799 HUMAN OTC DRUG Topcare Tussin DM Max Dextromethorphan HBr, Guaifenesin SUSPENSION ORAL 20100416 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 36800-800_9d086914-86f6-45f3-8bfa-4bdb00fdc3bf 36800-800 HUMAN OTC DRUG TopCare Nighttime Severe Cold and Cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20140318 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 36800-802_1a65c0d8-e9dd-4c1c-801b-b5a505a4ccc2 36800-802 HUMAN OTC DRUG Topcare Cold and Sore Throat Lemon Flavor Acetaminophen, Pheniramine Maleate, Phenylephrine HCl GRANULE, FOR SOLUTION ORAL 20140520 OTC MONOGRAPH FINAL part341 TOPCARE (Topco Associates LLC) ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 20; 10 mg/1; mg/1; mg/1 36800-804_c9c40c20-ae42-41ae-8d28-8ab83f9f779a 36800-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19910315 OTC MONOGRAPH NOT FINAL part333A TopCo Assoc LLC ISOPROPYL ALCOHOL .91 mg/mL 36800-807_c348f824-4ca9-41b6-8892-aad2427a778c 36800-807 HUMAN OTC DRUG Topcare Cold Remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20080904 UNAPPROVED HOMEOPATHIC Topco Associates LLC ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 36800-810_7f722279-022b-49c1-ac65-34bae33b6ecd 36800-810 HUMAN OTC DRUG Sinus and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20140530 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 36800-812_bdf2e24e-fa41-42bb-b21f-aa043d8ee2e9 36800-812 HUMAN OTC DRUG TopCare Sore Throat Honey Lemon Flavor BENZOCAINE, MENTHOL LOZENGE ORAL 20140225 OTC MONOGRAPH NOT FINAL part356 Topco Associates LLC BENZOCAINE; MENTHOL 15; 2.6 mg/1; mg/1 36800-813_876982d3-90ec-441e-a0a3-7c29cb235d31 36800-813 HUMAN OTC DRUG TopCare Sore Throat Cherry Flavor BENZOCAINE, MENTHOL LOZENGE ORAL 20140225 OTC MONOGRAPH NOT FINAL part356 Topco Associates LLC BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 36800-817_4fac7662-6311-4698-aae9-21f5513a9900 36800-817 HUMAN OTC DRUG Topcare Nasal Spray oxymetazoline hydrochloride SPRAY NASAL 19960806 OTC MONOGRAPH FINAL part341 Topco Associates LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 36800-824_582c6956-ca82-441c-a3c8-c4b40d7daeec 36800-824 HUMAN OTC DRUG Topcare Allergy Relief Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20040309 ANDA ANDA075990 Topco Associates LLC LORATADINE 10 mg/1 36800-825_351905b1-f78c-4838-a036-23b2bfc775f2 36800-825 HUMAN OTC DRUG Topcare Miconazole 7 Miconazole nitrate CREAM VAGINAL 20000229 ANDA ANDA074760 Topco Associates LLC MICONAZOLE NITRATE 2 g/100g 36800-829_5fd9958b-f195-4a23-894c-4adf2bb9ffcd 36800-829 HUMAN OTC DRUG topcare pain relief pm extra strength Acetaminophen, Diphenhydramine HCl CAPSULE, COATED ORAL 19920218 OTC MONOGRAPH FINAL part338 Topco Associates LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 36800-835_593a946b-4cfe-4f45-b754-4d1e63b2fdb1 36800-835 HUMAN OTC DRUG TopCare Earwax Removal Kit CARBAMIDE PEROXIDE LIQUID TOPICAL 20141128 OTC MONOGRAPH FINAL part344 TOPCO ASSOCIATES LLC CARBAMIDE PEROXIDE 65 mg/mL 36800-839_e1662578-63c7-43e9-93f5-4d1603cadc6d 36800-839 HUMAN OTC DRUG topcare childrens mucus relief multi symptom cold dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20140808 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 36800-843_c4847242-a324-45a3-96b0-68345b245b1a 36800-843 HUMAN OTC DRUG topcare hemorrhoidal cooling Phenylephrine HCl, Witch hazel GEL TOPICAL 20101208 OTC MONOGRAPH FINAL part346 Topco Associates LLC PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/100g; g/100g 36800-851_73e9527d-1a2e-4259-ad5c-f52c3554359c 36800-851 HUMAN OTC DRUG Topcare Antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20021203 OTC MONOGRAPH FINAL part332 Topco Associates LLC ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 36800-852_3ad29b16-06fa-401c-b7b5-bc677cf1c52e 36800-852 HUMAN OTC DRUG Topcare Heartburn Relief 150 Ranitidine TABLET, FILM COATED ORAL 20080215 ANDA ANDA091429 Topco Associates LLC RANITIDINE HYDROCHLORIDE 150 mg/1 36800-854_e40f4010-227c-4282-91a1-0a35b9e6d50a 36800-854 HUMAN OTC DRUG Topcare nicotine stop smoking aid Nicotine polacrilex GUM, CHEWING ORAL 20100128 ANDA ANDA078546 Topco Associates LLC NICOTINE 4 mg/1 36800-866_b5569e56-1037-4995-ab3f-633d12f88d7b 36800-866 HUMAN OTC DRUG Topcare Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070905 OTC MONOGRAPH FINAL part358G Topco Associates LLC PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 36800-872_85047476-b974-407e-aa93-1471d2ccfd9f 36800-872 HUMAN OTC DRUG Topcare Nite Time Cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120717 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 36800-873_878fae64-91ea-404c-acb3-e5290b4f1d6c 36800-873 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex LOZENGE ORAL 20061227 ANDA ANDA077007 Topco Associates LLC NICOTINE 4 mg/1 36800-882_8fc2e78c-2991-4f88-a65f-ce53bbf95df2 36800-882 HUMAN OTC DRUG Topcare Gas Relief Simethicone EMULSION ORAL 20031120 OTC MONOGRAPH FINAL part332 Topco Associates LLC DIMETHICONE 20 mg/.3mL 36800-886_942aa759-39d0-4457-9845-5a3b18ced769 36800-886 HUMAN OTC DRUG Topcare Sinus Congestion and Pain Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20090415 OTC MONOGRAPH FINAL part341 Topco Associates LLC 36800-896_0cc92ee4-4cd5-4488-9f77-48921297d501 36800-896 HUMAN OTC DRUG Topcare Lubricant Eye Polyethylene glycol, Propylene glycol SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130904 OTC MONOGRAPH FINAL part349 Topco Associates LLC POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 g/100mL; g/100mL 36800-897_e26b41a5-7f82-40ff-bd08-21bbce9b6aea 36800-897 HUMAN OTC DRUG topcare ibuprofen Ibuprofen SUSPENSION ORAL 19981231 ANDA ANDA074937 Topco Associates LLC IBUPROFEN 100 mg/5mL 36800-901_ec74b478-832a-41ad-bdf1-17bf656cbb2c 36800-901 HUMAN OTC DRUG Topcare Cold and Cough Acetaminophen, Dextromethorphan HBr SOLUTION ORAL 20140415 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 500; 15 mg/15mL; mg/15mL 36800-903_f96b30bc-6050-4bab-959f-1721e6df1b67 36800-903 HUMAN OTC DRUG Topcare Cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20090724 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 36800-906_7ff44ed8-98f2-4b70-a0a4-411db3dad13c 36800-906 HUMAN OTC DRUG Topcare Childrens Cold and Allergy Elixer phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20060921 OTC MONOGRAPH FINAL part341 Topco Associates LLC BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 36800-908_7805c020-f15f-49d2-9c15-9f37a229e38e 36800-908 HUMAN OTC DRUG TopCare Nite Time Cold and flu acetaminophen, dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20060719 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 36800-912_0781ae01-b6e8-43bd-916f-f5577601c8c3 36800-912 HUMAN OTC DRUG Topcare Day Time Nite Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20070806 OTC MONOGRAPH FINAL part341 Topco Associates LLC 36800-913_b6cf7b9c-7153-4dcd-afe0-7088eb9c8405 36800-913 HUMAN OTC DRUG Topcare Childrens Triacting Nightime Cold and Cough Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20070927 OTC MONOGRAPH FINAL part341 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 36800-915_64f33090-727f-46a5-81fe-cae1b6f867f7 36800-915 HUMAN OTC DRUG TopCare Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080229 NDA NDA022032 Topco Associates LLC OMEPRAZOLE 20 mg/1 36800-917_e6374ffb-0c10-4fdd-9e0f-f2efacaadf1f 36800-917 HUMAN OTC DRUG Topcare pain relief extra strength Acetaminophen CAPSULE, COATED ORAL 20110105 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 500 mg/1 36800-918_244b75c4-999f-4ebe-8158-afb247fd6fba 36800-918 HUMAN OTC DRUG Topcare sinus relief pressure and pain Acetaminophen, guaifenesin, phenylephrine HCl CAPSULE, COATED ORAL 20140622 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 36800-922_28ce95cd-5931-4af5-a8b4-f8f6d67eb893 36800-922 HUMAN OTC DRUG Topcare Mucus Relief Severe Congestion and Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130628 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 36800-923_211e4d07-42e9-442a-8208-c98a574c54ec 36800-923 HUMAN OTC DRUG Topcare Eye Itch Relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20130208 ANDA ANDA077958 Topco Associates LLC KETOTIFEN FUMARATE .25 mg/mL 36800-926_17a93055-1606-45da-8cc6-e9820a90dd33 36800-926 HUMAN OTC DRUG Topcare Day Time Nite Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20071219 OTC MONOGRAPH FINAL part341 Topco Associates LLC 36800-935_163f2502-e934-4405-9c36-af1c8cd6794d 36800-935 HUMAN OTC DRUG Topcare Sinus Congestion and Pain Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20090323 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 36800-936_e7ffab82-da1d-4b88-83ae-fd5746c886df 36800-936 HUMAN OTC DRUG Topcare Sinus Relief Day Time Night Time Acetaminophen, guaifenesin, diphenhydramine HCl, phenylephrine HCl KIT 20140622 OTC MONOGRAPH FINAL part341 Topco Associates LLC 36800-941_5d07b4fc-3a5d-4bc9-b313-da06c0b279ed 36800-941 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130801 OTC MONOGRAPH NOT FINAL part356 Topco EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 36800-942_674cf888-0fa4-4a7d-ae02-78ff9838b7db 36800-942 HUMAN OTC DRUG Antibacterial Body Wash Benzalkonium chloride LOTION TOPICAL 20140514 OTC MONOGRAPH NOT FINAL part333A Topco Associates LLC BENZALKONIUM CHLORIDE 1.313 mg/mL 36800-944_5e13da07-48cf-40bc-bb11-fd891886cbea 36800-944 HUMAN OTC DRUG topcare hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20111103 OTC MONOGRAPH FINAL part346 Topco Associates LLC GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g 36800-946_05ac413c-0f4e-4f79-b05b-cdcfa8714b1d 36800-946 HUMAN OTC DRUG topcare infants pain and fever Acetaminophen SUSPENSION ORAL 20110824 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL 36800-949_b3724b3c-3c14-4e54-a6b5-9b6d0139d972 36800-949 HUMAN OTC DRUG TopCare Milk of Magnesia Magnesium hydroxide LIQUID ORAL 20060220 OTC MONOGRAPH NOT FINAL part334 Topco Associates LLC MAGNESIUM HYDROXIDE 1200 mg/15mL 36800-950_ce90b0eb-6d1b-4f2e-bf46-3ef77af3520a 36800-950 HUMAN OTC DRUG topcare heartburn relief 150 Ranitidine TABLET, FILM COATED ORAL 20111010 ANDA ANDA091429 Topco Associates LLC RANITIDINE HYDROCHLORIDE 150 mg/1 36800-951_d92d36d6-196e-42be-848f-8ba6f5ac3395 36800-951 HUMAN OTC DRUG TopCare Mucus Relief and Cold and Flu Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl, diphenhydramine HCl KIT 20140624 OTC MONOGRAPH FINAL part341 Topco Associates LLC 36800-952_f7c893ce-6b42-43db-9276-88d18b5c68f7 36800-952 HUMAN OTC DRUG Castor Oil Castor Oil LIQUID ORAL 19910915 OTC MONOGRAPH NOT FINAL part334 TOPCO Associates LLC CASTOR OIL 1 g/mL 36800-955_5db4d503-dcf3-4666-bc47-a319c854c42f 36800-955 HUMAN OTC DRUG topcare lice treatment Permethrin LOTION TOPICAL 20110914 ANDA ANDA076090 Topco Associates LLC PERMETHRIN 1 mg/100mL 36800-957_8e89e535-b9f3-4a69-b267-23258b4d19d8 36800-957 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex LOZENGE ORAL 20130214 ANDA ANDA203690 Topco Associates LLC NICOTINE 4 mg/1 36800-958_93842397-7047-4ad6-9003-5e043ab5631b 36800-958 HUMAN OTC DRUG TopCare Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130822 ANDA ANDA091135 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 36800-959_b3e05c88-3144-49ec-b4ac-378ab90d6433 36800-959 HUMAN OTC DRUG topcare childrens pain and fever Acetaminophen SUSPENSION ORAL 20120227 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL 36800-964_a5a46806-2761-4d69-9c7a-3846e5ab07ac 36800-964 HUMAN OTC DRUG topcare flu and severe cold and cough Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20120910 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 36800-966_0f0c9581-703b-4522-83c9-3272c2071b07 36800-966 HUMAN OTC DRUG Topcare Arthritis Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070820 ANDA ANDA075077 Topco Associates LLC ACETAMINOPHEN 650 mg/1 36800-970_9fed1b78-60ce-49d3-b522-1846f5e99ddf 36800-970 HUMAN OTC DRUG Allergy Diphenhydramine HCl CAPSULE ORAL 20131130 OTC MONOGRAPH FINAL part336 TOP CARE (Topco Associates LLC) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 36800-971_99950203-f4ab-4a31-8bb9-a204a84c8e71 36800-971 HUMAN OTC DRUG Anticavity Sodium Fluoride RINSE ORAL 20130919 OTC MONOGRAPH FINAL part355 TOPCO Associates LLC SODIUM FLUORIDE .02 mg/mL 36800-974_d80d9a80-a128-448f-ae0c-23f1ea05db3d 36800-974 HUMAN OTC DRUG TopCare Childrens All Day Allergy cetirizine hydrochloride LIQUID ORAL 20080417 ANDA ANDA090254 Topco Associates LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL 36800-977_9abad9b8-ea21-4435-84b7-2b48aedfc696 36800-977 HUMAN OTC DRUG TopCare Nite Time Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20060612 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 36800-980_137411e8-5c57-42f6-bd7a-acae18d048c5 36800-980 HUMAN OTC DRUG Topcare Pain Relief Infants Acetaminophen SUSPENSION/ DROPS ORAL 19920713 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 80 mg/.8mL 36800-982_4123d258-d370-4755-8ffc-380bc51cfb9d 36800-982 HUMAN OTC DRUG topcare miconazole 3 combination pack Miconazole nitrate KIT 20041117 ANDA ANDA076357 Topco Associates LLC 36800-987_d141bcb7-b509-4011-b17a-7d67635ec1e7 36800-987 HUMAN OTC DRUG Topcare childrens cold and cough elixir Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20060929 OTC MONOGRAPH FINAL part343 Topco Associates LLC BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 36800-990_34afa9a1-fd5b-427b-bd52-f0368ad6688e 36800-990 HUMAN OTC DRUG Topcare Nite Time Multi Symptom Relief acetaminophen, dextromethorphan hydrobromide, doxylamine succinate LIQUID ORAL 20090728 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 36800-997_65978170-5662-4111-a133-230f73f0c5b5 36800-997 HUMAN OTC DRUG Topcare Sinus Relief Acetaminophen, guaifenesin, phenylephrine HCl CAPSULE, COATED ORAL 20140622 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 36800-998_3dc6d043-b684-4fa0-82b8-2d69887a16a6 36800-998 HUMAN OTC DRUG topcare nite time cold and flu relief multi symptom relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20060612 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 36800-999_069955ad-b96a-4d2d-9de2-6cd7475742ff 36800-999 HUMAN OTC DRUG topcare cold and flu night time Acetaminophen, diphenhydramine HCl, phenylephrine HCl TABLET, FILM COATED ORAL 20140624 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 36987-1001_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1001 HUMAN PRESCRIPTION DRUG Cattle Epithelium Cattle Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOS TAURUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1002_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1002 HUMAN PRESCRIPTION DRUG Cattle Epithelium Cattle Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOS TAURUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1003_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1003 HUMAN PRESCRIPTION DRUG Cattle Epithelium Cattle Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOS TAURUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1004_b8207809-3a22-4e67-8783-87f426677ccf 36987-1004 HUMAN PRESCRIPTION DRUG Cattle Epithelium Cattle Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOS TAURUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1005_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1005 HUMAN PRESCRIPTION DRUG Cattle Epithelium Cattle Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOS TAURUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1006_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1006 HUMAN PRESCRIPTION DRUG Cattle Epithelium Cattle Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOS TAURUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1007_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1007 HUMAN PRESCRIPTION DRUG Cattle Epithelium Cattle Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOS TAURUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1008_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1008 HUMAN PRESCRIPTION DRUG Cattle Epithelium Cattle Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOS TAURUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1009_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1009 HUMAN PRESCRIPTION DRUG Dog Epithelium Dog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANIS LUPUS FAMILIARIS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1010_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1010 HUMAN PRESCRIPTION DRUG Dog Epithelium Dog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANIS LUPUS FAMILIARIS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1011_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1011 HUMAN PRESCRIPTION DRUG Dog Epithelium Dog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANIS LUPUS FAMILIARIS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1012_b8207809-3a22-4e67-8783-87f426677ccf 36987-1012 HUMAN PRESCRIPTION DRUG Dog Epithelium Dog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANIS LUPUS FAMILIARIS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1013_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1013 HUMAN PRESCRIPTION DRUG Dog Epithelium Dog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANIS LUPUS FAMILIARIS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1014_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1014 HUMAN PRESCRIPTION DRUG Dog Epithelium Dog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANIS LUPUS FAMILIARIS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1015_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1015 HUMAN PRESCRIPTION DRUG Dog Epithelium Dog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANIS LUPUS FAMILIARIS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1016_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1016 HUMAN PRESCRIPTION DRUG Dog Epithelium Dog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANIS LUPUS FAMILIARIS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1017_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1017 HUMAN PRESCRIPTION DRUG Chicken Feathers Chicken Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GALLUS GALLUS FEATHER 10000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1018_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1018 HUMAN PRESCRIPTION DRUG Chicken Feathers Chicken Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GALLUS GALLUS FEATHER 10000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1019_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1019 HUMAN PRESCRIPTION DRUG Chicken Feathers Chicken Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GALLUS GALLUS FEATHER 20000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1020_b8207809-3a22-4e67-8783-87f426677ccf 36987-1020 HUMAN PRESCRIPTION DRUG Chicken Feathers Chicken Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GALLUS GALLUS FEATHER 20000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1021_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1021 HUMAN PRESCRIPTION DRUG Chicken Feathers Chicken Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GALLUS GALLUS FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1022_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1022 HUMAN PRESCRIPTION DRUG Chicken Feathers Chicken Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GALLUS GALLUS FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1023_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1023 HUMAN PRESCRIPTION DRUG Chicken Feathers Chicken Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GALLUS GALLUS FEATHER .1 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1024_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1024 HUMAN PRESCRIPTION DRUG Chicken Feathers Chicken Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GALLUS GALLUS FEATHER .1 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1025_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1025 HUMAN PRESCRIPTION DRUG Duck Feathers Duck Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER 10000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1026_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1026 HUMAN PRESCRIPTION DRUG Duck Feathers Duck Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER 10000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1027_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1027 HUMAN PRESCRIPTION DRUG Duck Feathers Duck Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER 20000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1028_b8207809-3a22-4e67-8783-87f426677ccf 36987-1028 HUMAN PRESCRIPTION DRUG Duck Feathers Duck Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER 20000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1029_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1029 HUMAN PRESCRIPTION DRUG Duck Feathers Duck Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1030_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1030 HUMAN PRESCRIPTION DRUG Duck Feathers Duck Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1031_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1031 HUMAN PRESCRIPTION DRUG Duck Feathers Duck Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER .1 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1032_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1032 HUMAN PRESCRIPTION DRUG Duck Feathers Duck Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER .1 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1033_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1033 HUMAN PRESCRIPTION DRUG Goose Feathers Goose Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANSER ANSER FEATHER 10000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1034_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1034 HUMAN PRESCRIPTION DRUG Goose Feathers Goose Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANSER ANSER FEATHER 10000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1035_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1035 HUMAN PRESCRIPTION DRUG Goose Feathers Goose Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANSER ANSER FEATHER 20000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1036_b8207809-3a22-4e67-8783-87f426677ccf 36987-1036 HUMAN PRESCRIPTION DRUG Goose Feathers Goose Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANSER ANSER FEATHER 20000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1037_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1037 HUMAN PRESCRIPTION DRUG Goose Feathers Goose Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANSER ANSER FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1038_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1038 HUMAN PRESCRIPTION DRUG Goose Feathers Goose Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANSER ANSER FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1039_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1039 HUMAN PRESCRIPTION DRUG Goose Feathers Goose Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANSER ANSER FEATHER .1 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1040_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1040 HUMAN PRESCRIPTION DRUG Goose Feathers Goose Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANSER ANSER FEATHER .1 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1041_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1041 HUMAN PRESCRIPTION DRUG Gerbil Epithelium Gerbil Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MERIONES UNGUICULATUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1042_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1042 HUMAN PRESCRIPTION DRUG Gerbil Epithelium Gerbil Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MERIONES UNGUICULATUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1043_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1043 HUMAN PRESCRIPTION DRUG Gerbil Epithelium Gerbil Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MERIONES UNGUICULATUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1044_b8207809-3a22-4e67-8783-87f426677ccf 36987-1044 HUMAN PRESCRIPTION DRUG Gerbil Epithelium Gerbil Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MERIONES UNGUICULATUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1045_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1045 HUMAN PRESCRIPTION DRUG Gerbil Epithelium Gerbil Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MERIONES UNGUICULATUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1046_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1046 HUMAN PRESCRIPTION DRUG Gerbil Epithelium Gerbil Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MERIONES UNGUICULATUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1047_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1047 HUMAN PRESCRIPTION DRUG Gerbil Epithelium Gerbil Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MERIONES UNGUICULATUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1048_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1048 HUMAN PRESCRIPTION DRUG Gerbil Epithelium Gerbil Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MERIONES UNGUICULATUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1049_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1049 HUMAN PRESCRIPTION DRUG Goat Epithelium Goat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAPRA HIRCUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1050_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1050 HUMAN PRESCRIPTION DRUG Goat Epithelium Goat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAPRA HIRCUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1051_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1051 HUMAN PRESCRIPTION DRUG Goat Epithelium Goat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAPRA HIRCUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1052_b8207809-3a22-4e67-8783-87f426677ccf 36987-1052 HUMAN PRESCRIPTION DRUG Goat Epithelium Goat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAPRA HIRCUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1053_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1053 HUMAN PRESCRIPTION DRUG Goat Epithelium Goat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAPRA HIRCUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1054_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1054 HUMAN PRESCRIPTION DRUG Goat Epithelium Goat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAPRA HIRCUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1055_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1055 HUMAN PRESCRIPTION DRUG Goat Epithelium Goat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAPRA HIRCUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1056_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1056 HUMAN PRESCRIPTION DRUG Goat Epithelium Goat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAPRA HIRCUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1057_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1057 HUMAN PRESCRIPTION DRUG Guinea Pig Epithelium Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAVIA PORCELLUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1058_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1058 HUMAN PRESCRIPTION DRUG Guinea Pig Epithelium Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAVIA PORCELLUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1059_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1059 HUMAN PRESCRIPTION DRUG Guinea Pig Epithelium Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAVIA PORCELLUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1060_b8207809-3a22-4e67-8783-87f426677ccf 36987-1060 HUMAN PRESCRIPTION DRUG Guinea Pig Epithelium Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAVIA PORCELLUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1061_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1061 HUMAN PRESCRIPTION DRUG Guinea Pig Epithelium Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAVIA PORCELLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1062_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1062 HUMAN PRESCRIPTION DRUG Guinea Pig Epithelium Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAVIA PORCELLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1063_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1063 HUMAN PRESCRIPTION DRUG Guinea Pig Epithelium Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAVIA PORCELLUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1064_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1064 HUMAN PRESCRIPTION DRUG Guinea Pig Epithelium Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAVIA PORCELLUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1065_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1065 HUMAN PRESCRIPTION DRUG Hamster Epithelium Hamster Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MESOCRICETUS AURATUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1066_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1066 HUMAN PRESCRIPTION DRUG Hamster Epithelium Hamster Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MESOCRICETUS AURATUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1067_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1067 HUMAN PRESCRIPTION DRUG Hamster Epithelium Hamster Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MESOCRICETUS AURATUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1068_b8207809-3a22-4e67-8783-87f426677ccf 36987-1068 HUMAN PRESCRIPTION DRUG Hamster Epithelium Hamster Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MESOCRICETUS AURATUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1069_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1069 HUMAN PRESCRIPTION DRUG Hamster Epithelium Hamster Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MESOCRICETUS AURATUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1070_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1070 HUMAN PRESCRIPTION DRUG Hamster Epithelium Hamster Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MESOCRICETUS AURATUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1071_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1071 HUMAN PRESCRIPTION DRUG Hamster Epithelium Hamster Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MESOCRICETUS AURATUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1072_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1072 HUMAN PRESCRIPTION DRUG Hamster Epithelium Hamster Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MESOCRICETUS AURATUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1073_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1073 HUMAN PRESCRIPTION DRUG Hog Epithelium Hog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SUS SCROFA SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1074_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1074 HUMAN PRESCRIPTION DRUG Hog Epithelium Hog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SUS SCROFA SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1075_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1075 HUMAN PRESCRIPTION DRUG Hog Epithelium Hog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SUS SCROFA SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1076_b8207809-3a22-4e67-8783-87f426677ccf 36987-1076 HUMAN PRESCRIPTION DRUG Hog Epithelium Hog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SUS SCROFA SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1077_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1077 HUMAN PRESCRIPTION DRUG Hog Epithelium Hog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SUS SCROFA SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1078_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1078 HUMAN PRESCRIPTION DRUG Hog Epithelium Hog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SUS SCROFA SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1079_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1079 HUMAN PRESCRIPTION DRUG Hog Epithelium Hog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SUS SCROFA SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1080_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1080 HUMAN PRESCRIPTION DRUG Hog Epithelium Hog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SUS SCROFA SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1081_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1081 HUMAN PRESCRIPTION DRUG Horse Epithelium Horse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EQUUS CABALLUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1082_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1082 HUMAN PRESCRIPTION DRUG Horse Epithelium Horse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EQUUS CABALLUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1083_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1083 HUMAN PRESCRIPTION DRUG Horse Epithelium Horse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EQUUS CABALLUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1084_b8207809-3a22-4e67-8783-87f426677ccf 36987-1084 HUMAN PRESCRIPTION DRUG Horse Epithelium Horse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EQUUS CABALLUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1085_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1085 HUMAN PRESCRIPTION DRUG Horse Epithelium Horse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EQUUS CABALLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1086_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1086 HUMAN PRESCRIPTION DRUG Horse Epithelium Horse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EQUUS CABALLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1087_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1087 HUMAN PRESCRIPTION DRUG Horse Epithelium Horse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EQUUS CABALLUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1088_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1088 HUMAN PRESCRIPTION DRUG Horse Epithelium Horse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EQUUS CABALLUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1089_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1089 HUMAN PRESCRIPTION DRUG Mouse Epithelium Mouse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUS MUSCULUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1090_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1090 HUMAN PRESCRIPTION DRUG Mouse Epithelium Mouse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUS MUSCULUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1091_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1091 HUMAN PRESCRIPTION DRUG Mouse Epithelium Mouse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUS MUSCULUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1092_b8207809-3a22-4e67-8783-87f426677ccf 36987-1092 HUMAN PRESCRIPTION DRUG Mouse Epithelium Mouse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUS MUSCULUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1093_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1093 HUMAN PRESCRIPTION DRUG Mouse Epithelium Mouse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUS MUSCULUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1094_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1094 HUMAN PRESCRIPTION DRUG Mouse Epithelium Mouse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUS MUSCULUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1095_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1095 HUMAN PRESCRIPTION DRUG Mouse Epithelium Mouse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUS MUSCULUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1096_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1096 HUMAN PRESCRIPTION DRUG Mouse Epithelium Mouse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUS MUSCULUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1097_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1097 HUMAN PRESCRIPTION DRUG Rabbit Epithelium Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORYCTOLAGUS CUNICULUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1098_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1098 HUMAN PRESCRIPTION DRUG Rabbit Epithelium Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORYCTOLAGUS CUNICULUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1099_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1099 HUMAN PRESCRIPTION DRUG Rabbit Epithelium Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORYCTOLAGUS CUNICULUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1100_b8207809-3a22-4e67-8783-87f426677ccf 36987-1100 HUMAN PRESCRIPTION DRUG Rabbit Epithelium Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORYCTOLAGUS CUNICULUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1101_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1101 HUMAN PRESCRIPTION DRUG Rabbit Epithelium Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORYCTOLAGUS CUNICULUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1102_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1102 HUMAN PRESCRIPTION DRUG Rabbit Epithelium Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORYCTOLAGUS CUNICULUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1103_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1103 HUMAN PRESCRIPTION DRUG Rabbit Epithelium Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORYCTOLAGUS CUNICULUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1104_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1104 HUMAN PRESCRIPTION DRUG Rabbit Epithelium Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORYCTOLAGUS CUNICULUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1105_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1105 HUMAN PRESCRIPTION DRUG Rat Epithelium Rat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RATTUS NORVEGICUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1106_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1106 HUMAN PRESCRIPTION DRUG Rat Epithelium Rat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RATTUS NORVEGICUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1107_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1107 HUMAN PRESCRIPTION DRUG Rat Epithelium Rat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RATTUS NORVEGICUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1108_b8207809-3a22-4e67-8783-87f426677ccf 36987-1108 HUMAN PRESCRIPTION DRUG Rat Epithelium Rat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RATTUS NORVEGICUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1109_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1109 HUMAN PRESCRIPTION DRUG Rat Epithelium Rat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RATTUS NORVEGICUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1110_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1110 HUMAN PRESCRIPTION DRUG Rat Epithelium Rat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RATTUS NORVEGICUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1111_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1111 HUMAN PRESCRIPTION DRUG Rat Epithelium Rat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RATTUS NORVEGICUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1112_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1112 HUMAN PRESCRIPTION DRUG Rat Epithelium Rat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RATTUS NORVEGICUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1117_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1117 HUMAN PRESCRIPTION DRUG Silk Silk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOMBYX MORI FIBER .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Silk [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1118_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1118 HUMAN PRESCRIPTION DRUG Silk Silk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOMBYX MORI FIBER .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Silk [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1119_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1119 HUMAN PRESCRIPTION DRUG Silk Silk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOMBYX MORI FIBER .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Silk [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1120_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1120 HUMAN PRESCRIPTION DRUG Silk Silk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOMBYX MORI FIBER .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Silk [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1121_2493858b-a2cf-4002-9c34-c7ed847be36c 36987-1121 HUMAN PRESCRIPTION DRUG Standardized Cat Hair Standardized Cat Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920929 BLA BLA103384 Nelco Laboratories, Inc. FELIS CATUS HAIR 10000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] 36987-1122_0dacbc5b-587a-4c20-ad07-45caf841a3ba 36987-1122 HUMAN PRESCRIPTION DRUG House Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOUSE DUST 10000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 36987-1123_0dacbc5b-587a-4c20-ad07-45caf841a3ba 36987-1123 HUMAN PRESCRIPTION DRUG House Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOUSE DUST 10000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 36987-1124_0dacbc5b-587a-4c20-ad07-45caf841a3ba 36987-1124 HUMAN PRESCRIPTION DRUG House Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOUSE DUST 20000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 36987-1125_0dacbc5b-587a-4c20-ad07-45caf841a3ba 36987-1125 HUMAN PRESCRIPTION DRUG House Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOUSE DUST 20000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 36987-1126_0dacbc5b-587a-4c20-ad07-45caf841a3ba 36987-1126 HUMAN PRESCRIPTION DRUG House Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOUSE DUST 40000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 36987-1127_0dacbc5b-587a-4c20-ad07-45caf841a3ba 36987-1127 HUMAN PRESCRIPTION DRUG House Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOUSE DUST .05 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 36987-1128_0dacbc5b-587a-4c20-ad07-45caf841a3ba 36987-1128 HUMAN PRESCRIPTION DRUG House Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOUSE DUST .05 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 36987-1129_0dacbc5b-587a-4c20-ad07-45caf841a3ba 36987-1129 HUMAN PRESCRIPTION DRUG House Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOUSE DUST .1 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 36987-1130_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1130 HUMAN PRESCRIPTION DRUG Egg White Egg White INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG WHITE .05 g/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 36987-1131_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1131 HUMAN PRESCRIPTION DRUG Egg White Egg White INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG WHITE .05 g/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 36987-1132_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1132 HUMAN PRESCRIPTION DRUG Egg White Egg White INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG WHITE .1 g/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 36987-1133_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1133 HUMAN PRESCRIPTION DRUG Egg White Egg White INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG WHITE .1 g/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 36987-1134_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1134 HUMAN PRESCRIPTION DRUG Egg Yolk Egg Yolk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG YOLK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] 36987-1135_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1135 HUMAN PRESCRIPTION DRUG Egg Yolk Egg Yolk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG YOLK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] 36987-1136_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1136 HUMAN PRESCRIPTION DRUG Egg Yolk Egg Yolk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG YOLK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] 36987-1137_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1137 HUMAN PRESCRIPTION DRUG Egg Yolk Egg Yolk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG YOLK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] 36987-1138_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1138 HUMAN PRESCRIPTION DRUG Whole Egg Whole Egg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] 36987-1139_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1139 HUMAN PRESCRIPTION DRUG Whole Egg Whole Egg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] 36987-1140_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1140 HUMAN PRESCRIPTION DRUG Whole Egg Whole Egg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] 36987-1141_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1141 HUMAN PRESCRIPTION DRUG Whole Egg Whole Egg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] 36987-1142_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1142 HUMAN PRESCRIPTION DRUG Beef Beef INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BEEF .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1143_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1143 HUMAN PRESCRIPTION DRUG Beef Beef INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BEEF .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1144_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1144 HUMAN PRESCRIPTION DRUG Beef Beef INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BEEF .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1145_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1145 HUMAN PRESCRIPTION DRUG Beef Beef INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BEEF .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1146_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1146 HUMAN PRESCRIPTION DRUG Chicken Meat Chicken Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHICKEN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 36987-1147_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1147 HUMAN PRESCRIPTION DRUG Chicken Meat Chicken Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHICKEN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 36987-1148_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1148 HUMAN PRESCRIPTION DRUG Chicken Meat Chicken Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHICKEN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 36987-1149_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1149 HUMAN PRESCRIPTION DRUG Chicken Meat Chicken Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHICKEN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 36987-1150_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1150 HUMAN PRESCRIPTION DRUG Duck Meat Duck Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DUCK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 36987-1151_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1151 HUMAN PRESCRIPTION DRUG Duck Meat Duck Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DUCK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 36987-1152_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1152 HUMAN PRESCRIPTION DRUG Duck Meat Duck Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DUCK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 36987-1153_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1153 HUMAN PRESCRIPTION DRUG Duck Meat Duck Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DUCK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 36987-1154_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1154 HUMAN PRESCRIPTION DRUG Lamb Lamb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LAMB .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1155_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1155 HUMAN PRESCRIPTION DRUG Lamb Lamb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LAMB .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1156_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1156 HUMAN PRESCRIPTION DRUG Lamb Lamb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LAMB .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1157_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1157 HUMAN PRESCRIPTION DRUG Lamb Lamb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LAMB .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1158_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1158 HUMAN PRESCRIPTION DRUG Beef Liver Beef Liver INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- BEEF LIVER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1159_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1159 HUMAN PRESCRIPTION DRUG Beef Liver Beef Liver INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- BEEF LIVER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1160_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1160 HUMAN PRESCRIPTION DRUG Beef Liver Beef Liver INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- BEEF LIVER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1161_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1161 HUMAN PRESCRIPTION DRUG Beef Liver Beef Liver INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- BEEF LIVER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1162_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1162 HUMAN PRESCRIPTION DRUG Pork Pork INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PORK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1163_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1163 HUMAN PRESCRIPTION DRUG Pork Pork INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PORK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1164_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1164 HUMAN PRESCRIPTION DRUG Pork Pork INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PORK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1165_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1165 HUMAN PRESCRIPTION DRUG Pork Pork INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PORK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1166_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1166 HUMAN PRESCRIPTION DRUG Turkey Turkey INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TURKEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 36987-1167_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1167 HUMAN PRESCRIPTION DRUG Turkey Turkey INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TURKEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 36987-1168_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1168 HUMAN PRESCRIPTION DRUG Turkey Turkey INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TURKEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 36987-1169_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1169 HUMAN PRESCRIPTION DRUG Turkey Turkey INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TURKEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 36987-1170_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1170 HUMAN PRESCRIPTION DRUG Veal Veal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. VEAL .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1171_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1171 HUMAN PRESCRIPTION DRUG Veal Veal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. VEAL .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1172_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1172 HUMAN PRESCRIPTION DRUG Veal Veal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. VEAL .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1173_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1173 HUMAN PRESCRIPTION DRUG Veal Veal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. VEAL .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 36987-1174_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1174 HUMAN PRESCRIPTION DRUG Casein Casein INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASEIN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Caseins [Chemical/Ingredient] 36987-1175_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1175 HUMAN PRESCRIPTION DRUG Casein Casein INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASEIN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Caseins [Chemical/Ingredient] 36987-1176_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1176 HUMAN PRESCRIPTION DRUG Casein Casein INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASEIN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Caseins [Chemical/Ingredient] 36987-1177_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1177 HUMAN PRESCRIPTION DRUG Casein Casein INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASEIN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Caseins [Chemical/Ingredient] 36987-1178_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1178 HUMAN PRESCRIPTION DRUG Cows Milk Cows Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COW MILK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] 36987-1179_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1179 HUMAN PRESCRIPTION DRUG Cows Milk Cows Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COW MILK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] 36987-1180_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1180 HUMAN PRESCRIPTION DRUG Cows Milk Cows Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COW MILK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] 36987-1181_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1181 HUMAN PRESCRIPTION DRUG Cows Milk Cows Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COW MILK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] 36987-1182_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1182 HUMAN PRESCRIPTION DRUG Goats Milk Goats Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GOAT MILK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] 36987-1183_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1183 HUMAN PRESCRIPTION DRUG Goats Milk Goats Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GOAT MILK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] 36987-1184_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1184 HUMAN PRESCRIPTION DRUG Goats Milk Goats Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GOAT MILK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] 36987-1185_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1185 HUMAN PRESCRIPTION DRUG Goats Milk Goats Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GOAT MILK .01 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] 36987-1190_efd0d48e-a918-47ac-8a38-6bd92970e678 36987-1190 HUMAN PRESCRIPTION DRUG Bluefish Bluefish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLUEFISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1191_f5674b12-782b-4941-a56a-72e592cbddc4 36987-1191 HUMAN PRESCRIPTION DRUG Bluefish Bluefish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLUEFISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1192_3565cc6a-3d3e-4561-9faa-61899993b0b3 36987-1192 HUMAN PRESCRIPTION DRUG Bluefish Bluefish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLUEFISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1193_3483052b-e8ac-47fc-aa09-c1058d243ce2 36987-1193 HUMAN PRESCRIPTION DRUG Bluefish Bluefish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLUEFISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1194_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1194 HUMAN PRESCRIPTION DRUG Carp Carp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COMMON CARP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1195_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1195 HUMAN PRESCRIPTION DRUG Carp Carp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COMMON CARP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1196_2266ee8c-c745-471e-845a-267f11a1c269 36987-1196 HUMAN PRESCRIPTION DRUG Carp Carp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COMMON CARP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1197_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1197 HUMAN PRESCRIPTION DRUG Carp Carp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COMMON CARP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1198_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1198 HUMAN PRESCRIPTION DRUG Clam Clam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLAM .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1199_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1199 HUMAN PRESCRIPTION DRUG Clam Clam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLAM .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1200_2266ee8c-c745-471e-845a-267f11a1c269 36987-1200 HUMAN PRESCRIPTION DRUG Clam Clam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLAM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1201_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1201 HUMAN PRESCRIPTION DRUG Clam Clam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLAM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1202_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1202 HUMAN PRESCRIPTION DRUG Codfish Codfish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CODFISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1203_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1203 HUMAN PRESCRIPTION DRUG Codfish Codfish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CODFISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1204_2266ee8c-c745-471e-845a-267f11a1c269 36987-1204 HUMAN PRESCRIPTION DRUG Codfish Codfish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CODFISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1205_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1205 HUMAN PRESCRIPTION DRUG Codfish Codfish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CODFISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1206_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1206 HUMAN PRESCRIPTION DRUG Crab Crab INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CRAB .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1207_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1207 HUMAN PRESCRIPTION DRUG Crab Crab INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CRAB .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1208_2266ee8c-c745-471e-845a-267f11a1c269 36987-1208 HUMAN PRESCRIPTION DRUG Crab Crab INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CRAB .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1209_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1209 HUMAN PRESCRIPTION DRUG Crab Crab INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CRAB .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1210_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1210 HUMAN PRESCRIPTION DRUG Flounder Flounder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLOUNDER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1211_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1211 HUMAN PRESCRIPTION DRUG Flounder Flounder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLOUNDER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1212_2266ee8c-c745-471e-845a-267f11a1c269 36987-1212 HUMAN PRESCRIPTION DRUG Flounder Flounder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLOUNDER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1213_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1213 HUMAN PRESCRIPTION DRUG Flounder Flounder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLOUNDER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1214_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1214 HUMAN PRESCRIPTION DRUG Haddock Haddock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HADDOCK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1215_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1215 HUMAN PRESCRIPTION DRUG Haddock Haddock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HADDOCK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1216_2266ee8c-c745-471e-845a-267f11a1c269 36987-1216 HUMAN PRESCRIPTION DRUG Haddock Haddock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HADDOCK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1217_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1217 HUMAN PRESCRIPTION DRUG Haddock Haddock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HADDOCK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1218_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1218 HUMAN PRESCRIPTION DRUG Halibut Halibut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PACIFIC HALIBUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1219_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1219 HUMAN PRESCRIPTION DRUG Halibut Halibut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PACIFIC HALIBUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1220_2266ee8c-c745-471e-845a-267f11a1c269 36987-1220 HUMAN PRESCRIPTION DRUG Halibut Halibut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PACIFIC HALIBUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1221_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1221 HUMAN PRESCRIPTION DRUG Halibut Halibut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PACIFIC HALIBUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1222_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1222 HUMAN PRESCRIPTION DRUG Herring Herring INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HERRING .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1223_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1223 HUMAN PRESCRIPTION DRUG Herring Herring INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HERRING .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1224_2266ee8c-c745-471e-845a-267f11a1c269 36987-1224 HUMAN PRESCRIPTION DRUG Herring Herring INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HERRING .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1225_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1225 HUMAN PRESCRIPTION DRUG Herring Herring INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HERRING .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1226_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1226 HUMAN PRESCRIPTION DRUG Lobster Lobster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOBSTER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1227_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1227 HUMAN PRESCRIPTION DRUG Lobster Lobster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOBSTER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1228_2266ee8c-c745-471e-845a-267f11a1c269 36987-1228 HUMAN PRESCRIPTION DRUG Lobster Lobster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOBSTER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1229_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1229 HUMAN PRESCRIPTION DRUG Lobster Lobster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOBSTER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1230_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1230 HUMAN PRESCRIPTION DRUG Mackerel Mackerel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MACKEREL .05 g/mL 36987-1231_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1231 HUMAN PRESCRIPTION DRUG Mackerel Mackerel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MACKEREL .05 g/mL 36987-1232_2266ee8c-c745-471e-845a-267f11a1c269 36987-1232 HUMAN PRESCRIPTION DRUG Mackerel Mackerel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MACKEREL .1 g/mL 36987-1233_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1233 HUMAN PRESCRIPTION DRUG Mackerel Mackerel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MACKEREL .1 g/mL 36987-1234_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1234 HUMAN PRESCRIPTION DRUG Oyster Oyster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OYSTER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1235_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1235 HUMAN PRESCRIPTION DRUG Oyster Oyster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OYSTER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1236_2266ee8c-c745-471e-845a-267f11a1c269 36987-1236 HUMAN PRESCRIPTION DRUG Oyster Oyster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OYSTER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1237_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1237 HUMAN PRESCRIPTION DRUG Oyster Oyster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OYSTER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1238_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1238 HUMAN PRESCRIPTION DRUG Pike Pike INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NORTHERN PIKE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1239_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1239 HUMAN PRESCRIPTION DRUG Pike Pike INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NORTHERN PIKE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1240_2266ee8c-c745-471e-845a-267f11a1c269 36987-1240 HUMAN PRESCRIPTION DRUG Pike Pike INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NORTHERN PIKE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1241_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1241 HUMAN PRESCRIPTION DRUG Pike Pike INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NORTHERN PIKE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1242_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1242 HUMAN PRESCRIPTION DRUG Red Snapper Red Snapper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RED SNAPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1243_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1243 HUMAN PRESCRIPTION DRUG Red Snapper Red Snapper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RED SNAPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1244_2266ee8c-c745-471e-845a-267f11a1c269 36987-1244 HUMAN PRESCRIPTION DRUG Red Snapper Red Snapper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RED SNAPPER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1245_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1245 HUMAN PRESCRIPTION DRUG Red Snapper Red Snapper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RED SNAPPER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1246_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1246 HUMAN PRESCRIPTION DRUG Salmon Salmon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATLANTIC SALMON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1247_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1247 HUMAN PRESCRIPTION DRUG Salmon Salmon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATLANTIC SALMON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1248_2266ee8c-c745-471e-845a-267f11a1c269 36987-1248 HUMAN PRESCRIPTION DRUG Salmon Salmon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATLANTIC SALMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1249_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1249 HUMAN PRESCRIPTION DRUG Salmon Salmon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATLANTIC SALMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1250_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1250 HUMAN PRESCRIPTION DRUG Sardine Sardine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROPEAN PILCHARD .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1251_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1251 HUMAN PRESCRIPTION DRUG Sardine Sardine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROPEAN PILCHARD .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1252_2266ee8c-c745-471e-845a-267f11a1c269 36987-1252 HUMAN PRESCRIPTION DRUG Sardine Sardine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROPEAN PILCHARD .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1253_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1253 HUMAN PRESCRIPTION DRUG Sardine Sardine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROPEAN PILCHARD .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1254_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1254 HUMAN PRESCRIPTION DRUG Scallop Scallop INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SCALLOP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1255_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1255 HUMAN PRESCRIPTION DRUG Scallop Scallop INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SCALLOP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1256_2266ee8c-c745-471e-845a-267f11a1c269 36987-1256 HUMAN PRESCRIPTION DRUG Scallop Scallop INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SCALLOP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1257_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1257 HUMAN PRESCRIPTION DRUG Scallop Scallop INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SCALLOP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1258_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1258 HUMAN PRESCRIPTION DRUG Shrimp Shrimp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SHRIMP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1259_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1259 HUMAN PRESCRIPTION DRUG Shrimp Shrimp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SHRIMP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1260_2266ee8c-c745-471e-845a-267f11a1c269 36987-1260 HUMAN PRESCRIPTION DRUG Shrimp Shrimp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SHRIMP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1261_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1261 HUMAN PRESCRIPTION DRUG Shrimp Shrimp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SHRIMP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 36987-1262_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1262 HUMAN PRESCRIPTION DRUG Smelt Smelt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SMELT .05 g/mL 36987-1263_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1263 HUMAN PRESCRIPTION DRUG Smelt Smelt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SMELT .05 g/mL 36987-1264_2266ee8c-c745-471e-845a-267f11a1c269 36987-1264 HUMAN PRESCRIPTION DRUG Smelt Smelt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SMELT .1 g/mL 36987-1265_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1265 HUMAN PRESCRIPTION DRUG Smelt Smelt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SMELT .1 g/mL 36987-1266_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1266 HUMAN PRESCRIPTION DRUG Sword Fish Sword Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SWORDFISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1267_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1267 HUMAN PRESCRIPTION DRUG Sword Fish Sword Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SWORDFISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1268_2266ee8c-c745-471e-845a-267f11a1c269 36987-1268 HUMAN PRESCRIPTION DRUG Sword Fish Sword Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SWORDFISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1269_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1269 HUMAN PRESCRIPTION DRUG Sword Fish Sword Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SWORDFISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1270_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1270 HUMAN PRESCRIPTION DRUG Trout Trout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TROUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1271_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1271 HUMAN PRESCRIPTION DRUG Trout Trout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TROUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1272_2266ee8c-c745-471e-845a-267f11a1c269 36987-1272 HUMAN PRESCRIPTION DRUG Trout Trout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TROUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1273_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1273 HUMAN PRESCRIPTION DRUG Trout Trout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TROUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1274_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1274 HUMAN PRESCRIPTION DRUG Tuna Fish Tuna Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TUNA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1275_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1275 HUMAN PRESCRIPTION DRUG Tuna Fish Tuna Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TUNA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1276_2266ee8c-c745-471e-845a-267f11a1c269 36987-1276 HUMAN PRESCRIPTION DRUG Tuna Fish Tuna Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TUNA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1277_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1277 HUMAN PRESCRIPTION DRUG Tuna Fish Tuna Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TUNA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1278_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1278 HUMAN PRESCRIPTION DRUG White Fish White Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHITE FISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1279_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1279 HUMAN PRESCRIPTION DRUG White Fish White Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHITE FISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1280_2266ee8c-c745-471e-845a-267f11a1c269 36987-1280 HUMAN PRESCRIPTION DRUG White Fish White Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHITE FISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1281_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1281 HUMAN PRESCRIPTION DRUG White Fish White Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHITE FISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 36987-1282_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1282 HUMAN PRESCRIPTION DRUG Red Delicious Apple Red Delicious Apple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. APPLE .05 g/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] 36987-1283_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1283 HUMAN PRESCRIPTION DRUG Red Delicious Apple Red Delicious Apple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. APPLE .05 g/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] 36987-1284_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1284 HUMAN PRESCRIPTION DRUG Red Delicious Apple Red Delicious Apple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. APPLE .1 g/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] 36987-1285_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1285 HUMAN PRESCRIPTION DRUG Red Delicious Apple Red Delicious Apple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. APPLE .1 g/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] 36987-1286_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1286 HUMAN PRESCRIPTION DRUG Apricot Apricot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. APRICOT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1287_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1287 HUMAN PRESCRIPTION DRUG Apricot Apricot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. APRICOT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1288_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1288 HUMAN PRESCRIPTION DRUG Apricot Apricot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. APRICOT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1289_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1289 HUMAN PRESCRIPTION DRUG Apricot Apricot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. APRICOT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1290_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1290 HUMAN PRESCRIPTION DRUG Avocado Avocado INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVOCADO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1291_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1291 HUMAN PRESCRIPTION DRUG Avocado Avocado INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVOCADO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1292_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1292 HUMAN PRESCRIPTION DRUG Avocado Avocado INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVOCADO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1293_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1293 HUMAN PRESCRIPTION DRUG Avocado Avocado INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVOCADO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1294_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1294 HUMAN PRESCRIPTION DRUG Banana Banana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BANANA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1295_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1295 HUMAN PRESCRIPTION DRUG Banana Banana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BANANA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1296_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1296 HUMAN PRESCRIPTION DRUG Banana Banana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BANANA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1297_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1297 HUMAN PRESCRIPTION DRUG Banana Banana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BANANA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1298_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1298 HUMAN PRESCRIPTION DRUG Blackberry Blackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACKBERRY .05 g/mL 36987-1299_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1299 HUMAN PRESCRIPTION DRUG Blackberry Blackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACKBERRY .05 g/mL 36987-1300_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1300 HUMAN PRESCRIPTION DRUG Blackberry Blackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACKBERRY .1 g/mL 36987-1301_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1301 HUMAN PRESCRIPTION DRUG Blackberry Blackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACKBERRY .1 g/mL 36987-1302_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1302 HUMAN PRESCRIPTION DRUG Blueberry Blueberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLUEBERRY .05 g/mL 36987-1303_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1303 HUMAN PRESCRIPTION DRUG Blueberry Blueberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLUEBERRY .05 g/mL 36987-1304_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1304 HUMAN PRESCRIPTION DRUG Blueberry Blueberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLUEBERRY .1 g/mL 36987-1305_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1305 HUMAN PRESCRIPTION DRUG Blueberry Blueberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLUEBERRY .1 g/mL 36987-1306_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1306 HUMAN PRESCRIPTION DRUG Cantaloupe Cantaloupe INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANTALOUPE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1307_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1307 HUMAN PRESCRIPTION DRUG Cantaloupe Cantaloupe INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANTALOUPE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1308_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1308 HUMAN PRESCRIPTION DRUG Cantaloupe Cantaloupe INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANTALOUPE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1309_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1309 HUMAN PRESCRIPTION DRUG Cantaloupe Cantaloupe INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANTALOUPE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1310_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1310 HUMAN PRESCRIPTION DRUG Cherry Bing Cherry Bing INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOUR CHERRY .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1311_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1311 HUMAN PRESCRIPTION DRUG Cherry Bing Cherry Bing INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOUR CHERRY .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1312_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1312 HUMAN PRESCRIPTION DRUG Cherry Bing Cherry Bing INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOUR CHERRY .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1313_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1313 HUMAN PRESCRIPTION DRUG Cherry Bing Cherry Bing INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOUR CHERRY .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1314_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1314 HUMAN PRESCRIPTION DRUG Cranberry Cranberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CRANBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1315_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1315 HUMAN PRESCRIPTION DRUG Cranberry Cranberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CRANBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1316_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1316 HUMAN PRESCRIPTION DRUG Cranberry Cranberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CRANBERRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1317_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1317 HUMAN PRESCRIPTION DRUG Cranberry Cranberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CRANBERRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1318_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1318 HUMAN PRESCRIPTION DRUG Date Date INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DATE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1319_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1319 HUMAN PRESCRIPTION DRUG Date Date INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DATE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1320_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1320 HUMAN PRESCRIPTION DRUG Date Date INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DATE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1321_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1321 HUMAN PRESCRIPTION DRUG Date Date INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DATE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1322_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1322 HUMAN PRESCRIPTION DRUG Fig Fig INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FIG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1323_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1323 HUMAN PRESCRIPTION DRUG Fig Fig INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FIG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1324_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1324 HUMAN PRESCRIPTION DRUG Fig Fig INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FIG .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1325_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1325 HUMAN PRESCRIPTION DRUG Fig Fig INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FIG .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1326_5d401ba5-12ed-4caf-b4bd-ef67706de2e7 36987-1326 HUMAN PRESCRIPTION DRUG Thompson Seedless Grape Thompson Seedless Grape INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WINE GRAPE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1327_4b0b81c8-afbe-4531-82ab-623d63b0795f 36987-1327 HUMAN PRESCRIPTION DRUG Thompson Seedless Grape Thompson Seedless Grape INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WINE GRAPE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1328_4bc24d90-8765-49c7-9e9a-997a8a01fb7c 36987-1328 HUMAN PRESCRIPTION DRUG Thompson Seedless Grape Thompson Seedless Grape INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WINE GRAPE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1329_9136cb32-84a8-409d-857e-42ee3cff3460 36987-1329 HUMAN PRESCRIPTION DRUG Thompson Seedless Grape Thompson Seedless Grape INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WINE GRAPE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1330_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1330 HUMAN PRESCRIPTION DRUG Grapefruit Grapefruit INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GRAPEFRUIT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1331_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1331 HUMAN PRESCRIPTION DRUG Grapefruit Grapefruit INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GRAPEFRUIT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1332_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1332 HUMAN PRESCRIPTION DRUG Grapefruit Grapefruit INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GRAPEFRUIT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1333_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1333 HUMAN PRESCRIPTION DRUG Grapefruit Grapefruit INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GRAPEFRUIT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1334_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1334 HUMAN PRESCRIPTION DRUG Honeydew Melon Honeydew Melon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HONEYDEW MELON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1335_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1335 HUMAN PRESCRIPTION DRUG Honeydew Melon Honeydew Melon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HONEYDEW MELON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1336_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1336 HUMAN PRESCRIPTION DRUG Honeydew Melon Honeydew Melon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HONEYDEW MELON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1337_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1337 HUMAN PRESCRIPTION DRUG Honeydew Melon Honeydew Melon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HONEYDEW MELON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1338_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1338 HUMAN PRESCRIPTION DRUG Lemon Lemon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEMON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1339_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1339 HUMAN PRESCRIPTION DRUG Lemon Lemon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEMON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1340_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1340 HUMAN PRESCRIPTION DRUG Lemon Lemon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1341_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1341 HUMAN PRESCRIPTION DRUG Lemon Lemon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1342_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1342 HUMAN PRESCRIPTION DRUG Lime Lime INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIME (CITRUS) .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1343_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1343 HUMAN PRESCRIPTION DRUG Lime Lime INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIME (CITRUS) .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1344_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1344 HUMAN PRESCRIPTION DRUG Lime Lime INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIME (CITRUS) .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1345_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1345 HUMAN PRESCRIPTION DRUG Lime Lime INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIME (CITRUS) .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1346_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1346 HUMAN PRESCRIPTION DRUG Orange Orange INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORANGE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1347_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1347 HUMAN PRESCRIPTION DRUG Orange Orange INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORANGE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1348_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1348 HUMAN PRESCRIPTION DRUG Orange Orange INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORANGE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1349_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1349 HUMAN PRESCRIPTION DRUG Orange Orange INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORANGE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1350_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1350 HUMAN PRESCRIPTION DRUG Peach Peach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEACH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1351_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1351 HUMAN PRESCRIPTION DRUG Peach Peach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEACH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1352_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1352 HUMAN PRESCRIPTION DRUG Peach Peach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEACH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1353_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1353 HUMAN PRESCRIPTION DRUG Peach Peach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEACH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1354_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1354 HUMAN PRESCRIPTION DRUG Pear Pear INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEAR .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1355_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1355 HUMAN PRESCRIPTION DRUG Pear Pear INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEAR .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1356_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1356 HUMAN PRESCRIPTION DRUG Pear Pear INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEAR .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1357_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1357 HUMAN PRESCRIPTION DRUG Pear Pear INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEAR .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1358_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1358 HUMAN PRESCRIPTION DRUG Pineapple Pineapple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINEAPPLE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1359_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1359 HUMAN PRESCRIPTION DRUG Pineapple Pineapple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINEAPPLE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1360_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1360 HUMAN PRESCRIPTION DRUG Pineapple Pineapple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINEAPPLE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1361_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1361 HUMAN PRESCRIPTION DRUG Pineapple Pineapple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINEAPPLE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1362_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1362 HUMAN PRESCRIPTION DRUG Plum Plum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLUM .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1363_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1363 HUMAN PRESCRIPTION DRUG Plum Plum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLUM .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1364_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1364 HUMAN PRESCRIPTION DRUG Plum Plum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLUM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1365_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1365 HUMAN PRESCRIPTION DRUG Plum Plum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLUM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1366_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1366 HUMAN PRESCRIPTION DRUG Raspberry Raspberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RASPBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1367_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1367 HUMAN PRESCRIPTION DRUG Raspberry Raspberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RASPBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1368_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1368 HUMAN PRESCRIPTION DRUG Raspberry Raspberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RASPBERRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1369_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1369 HUMAN PRESCRIPTION DRUG Raspberry Raspberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RASPBERRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1370_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1370 HUMAN PRESCRIPTION DRUG Strawberry Strawberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STRAWBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1371_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1371 HUMAN PRESCRIPTION DRUG Strawberry Strawberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STRAWBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1372_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1372 HUMAN PRESCRIPTION DRUG Strawberry Strawberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STRAWBERRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1373_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1373 HUMAN PRESCRIPTION DRUG Strawberry Strawberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STRAWBERRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1374_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1374 HUMAN PRESCRIPTION DRUG Tangerine Tangerine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TANGERINE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1375_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1375 HUMAN PRESCRIPTION DRUG Tangerine Tangerine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TANGERINE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1376_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1376 HUMAN PRESCRIPTION DRUG Tangerine Tangerine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TANGERINE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1377_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1377 HUMAN PRESCRIPTION DRUG Tangerine Tangerine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TANGERINE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1378_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1378 HUMAN PRESCRIPTION DRUG Watermelon Watermelon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WATERMELON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1379_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1379 HUMAN PRESCRIPTION DRUG Watermelon Watermelon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WATERMELON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1380_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1380 HUMAN PRESCRIPTION DRUG Watermelon Watermelon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WATERMELON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1381_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1381 HUMAN PRESCRIPTION DRUG Watermelon Watermelon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WATERMELON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1382_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1382 HUMAN PRESCRIPTION DRUG Artichoke Artichoke INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTICHOKE .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1383_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1383 HUMAN PRESCRIPTION DRUG Artichoke Artichoke INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTICHOKE .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1384_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1384 HUMAN PRESCRIPTION DRUG Artichoke Artichoke INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTICHOKE .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1385_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1385 HUMAN PRESCRIPTION DRUG Artichoke Artichoke INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTICHOKE .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1386_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1386 HUMAN PRESCRIPTION DRUG Asparagus Asparagus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPARAGUS .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1387_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1387 HUMAN PRESCRIPTION DRUG Asparagus Asparagus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPARAGUS .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1388_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1388 HUMAN PRESCRIPTION DRUG Asparagus Asparagus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPARAGUS .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1389_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1389 HUMAN PRESCRIPTION DRUG Asparagus Asparagus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPARAGUS .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1390_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1390 HUMAN PRESCRIPTION DRUG Red Kidney Beans Red Kidney Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1391_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1391 HUMAN PRESCRIPTION DRUG Red Kidney Beans Red Kidney Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1392_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1392 HUMAN PRESCRIPTION DRUG Red Kidney Beans Red Kidney Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1393_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1393 HUMAN PRESCRIPTION DRUG Red Kidney Beans Red Kidney Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1394_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1394 HUMAN PRESCRIPTION DRUG Lima Beans Lima Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIMA BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1395_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1395 HUMAN PRESCRIPTION DRUG Lima Beans Lima Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIMA BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1396_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1396 HUMAN PRESCRIPTION DRUG Lima Beans Lima Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIMA BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1397_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1397 HUMAN PRESCRIPTION DRUG Lima Beans Lima Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIMA BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1398_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1398 HUMAN PRESCRIPTION DRUG Navy Beans Navy Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1399_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1399 HUMAN PRESCRIPTION DRUG Navy Beans Navy Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1400_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1400 HUMAN PRESCRIPTION DRUG Navy Beans Navy Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1401_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1401 HUMAN PRESCRIPTION DRUG Navy Beans Navy Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1402_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1402 HUMAN PRESCRIPTION DRUG String Beans String Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STRING BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1403_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1403 HUMAN PRESCRIPTION DRUG String Beans String Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STRING BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1404_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1404 HUMAN PRESCRIPTION DRUG String Beans String Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STRING BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1405_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1405 HUMAN PRESCRIPTION DRUG String Beans String Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STRING BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1406_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1406 HUMAN PRESCRIPTION DRUG Beet Beet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BEET .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1407_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1407 HUMAN PRESCRIPTION DRUG Beet Beet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BEET .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1408_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1408 HUMAN PRESCRIPTION DRUG Beet Beet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BEET .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1409_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1409 HUMAN PRESCRIPTION DRUG Beet Beet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BEET .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1410_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1410 HUMAN PRESCRIPTION DRUG Broccoli Broccoli INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROCCOLI .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1411_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1411 HUMAN PRESCRIPTION DRUG Broccoli Broccoli INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROCCOLI .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1412_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1412 HUMAN PRESCRIPTION DRUG Broccoli Broccoli INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROCCOLI .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1413_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1413 HUMAN PRESCRIPTION DRUG Broccoli Broccoli INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROCCOLI .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1414_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1414 HUMAN PRESCRIPTION DRUG Kiwi Kiwi INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIWI FRUIT .05 g/mL 36987-1415_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1415 HUMAN PRESCRIPTION DRUG Kiwi Kiwi INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIWI FRUIT .05 g/mL 36987-1416_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1416 HUMAN PRESCRIPTION DRUG Kiwi Kiwi INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIWI FRUIT .1 g/mL 36987-1417_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1417 HUMAN PRESCRIPTION DRUG Kiwi Kiwi INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIWI FRUIT .1 g/mL 36987-1418_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1418 HUMAN PRESCRIPTION DRUG Brussels Sprout Brussels Sprout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BRUSSELS SPROUT .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1419_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1419 HUMAN PRESCRIPTION DRUG Brussels Sprout Brussels Sprout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BRUSSELS SPROUT .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1420_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1420 HUMAN PRESCRIPTION DRUG Brussels Sprout Brussels Sprout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BRUSSELS SPROUT .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1421_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1421 HUMAN PRESCRIPTION DRUG Brussels Sprout Brussels Sprout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BRUSSELS SPROUT .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1422_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1422 HUMAN PRESCRIPTION DRUG Cabbage Cabbage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CABBAGE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1423_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1423 HUMAN PRESCRIPTION DRUG Cabbage Cabbage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CABBAGE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1424_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1424 HUMAN PRESCRIPTION DRUG Cabbage Cabbage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CABBAGE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1425_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1425 HUMAN PRESCRIPTION DRUG Cabbage Cabbage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CABBAGE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1426_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1426 HUMAN PRESCRIPTION DRUG Carrot Carrot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARROT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1427_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1427 HUMAN PRESCRIPTION DRUG Carrot Carrot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARROT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1428_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1428 HUMAN PRESCRIPTION DRUG Carrot Carrot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARROT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1429_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1429 HUMAN PRESCRIPTION DRUG Carrot Carrot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARROT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1430_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1430 HUMAN PRESCRIPTION DRUG Cauliflower Cauliflower INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAULIFLOWER .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1431_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1431 HUMAN PRESCRIPTION DRUG Cauliflower Cauliflower INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAULIFLOWER .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1432_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1432 HUMAN PRESCRIPTION DRUG Cauliflower Cauliflower INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAULIFLOWER .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1433_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1433 HUMAN PRESCRIPTION DRUG Cauliflower Cauliflower INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAULIFLOWER .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1434_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1434 HUMAN PRESCRIPTION DRUG Celery Celery INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELERY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1435_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1435 HUMAN PRESCRIPTION DRUG Celery Celery INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELERY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1436_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1436 HUMAN PRESCRIPTION DRUG Celery Celery INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELERY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1437_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1437 HUMAN PRESCRIPTION DRUG Celery Celery INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELERY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1438_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1438 HUMAN PRESCRIPTION DRUG Sweet Corn Sweet Corn INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1439_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1439 HUMAN PRESCRIPTION DRUG Sweet Corn Sweet Corn INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1440_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1440 HUMAN PRESCRIPTION DRUG Sweet Corn Sweet Corn INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1441_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1441 HUMAN PRESCRIPTION DRUG Sweet Corn Sweet Corn INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1442_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1442 HUMAN PRESCRIPTION DRUG Cucumber Cucumber INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUCUMBER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1443_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1443 HUMAN PRESCRIPTION DRUG Cucumber Cucumber INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUCUMBER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1444_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1444 HUMAN PRESCRIPTION DRUG Cucumber Cucumber INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUCUMBER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1445_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1445 HUMAN PRESCRIPTION DRUG Cucumber Cucumber INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUCUMBER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1446_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1446 HUMAN PRESCRIPTION DRUG Egg Plant Egg Plant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGGPLANT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1447_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1447 HUMAN PRESCRIPTION DRUG Egg Plant Egg Plant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGGPLANT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1448_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1448 HUMAN PRESCRIPTION DRUG Egg Plant Egg Plant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGGPLANT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1449_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1449 HUMAN PRESCRIPTION DRUG Egg Plant Egg Plant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGGPLANT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1450_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1450 HUMAN PRESCRIPTION DRUG Green Pepper Green Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GREEN BELL PEPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1451_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1451 HUMAN PRESCRIPTION DRUG Green Pepper Green Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GREEN BELL PEPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1452_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1452 HUMAN PRESCRIPTION DRUG Green Pepper Green Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GREEN BELL PEPPER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1453_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1453 HUMAN PRESCRIPTION DRUG Green Pepper Green Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GREEN BELL PEPPER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1454_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1454 HUMAN PRESCRIPTION DRUG Lentil Lentil INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LENTIL .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1455_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1455 HUMAN PRESCRIPTION DRUG Lentil Lentil INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LENTIL .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1456_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1456 HUMAN PRESCRIPTION DRUG Lentil Lentil INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LENTIL .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1457_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1457 HUMAN PRESCRIPTION DRUG Lentil Lentil INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LENTIL .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1458_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1458 HUMAN PRESCRIPTION DRUG Iceberg Lettuce Iceberg Lettuce INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LETTUCE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1459_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1459 HUMAN PRESCRIPTION DRUG Iceberg Lettuce Iceberg Lettuce INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LETTUCE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1460_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1460 HUMAN PRESCRIPTION DRUG Iceberg Lettuce Iceberg Lettuce INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LETTUCE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1461_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1461 HUMAN PRESCRIPTION DRUG Iceberg Lettuce Iceberg Lettuce INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LETTUCE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1462_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1462 HUMAN PRESCRIPTION DRUG Mushroom Mushroom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CULTIVATED MUSHROOM .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-1463_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1463 HUMAN PRESCRIPTION DRUG Mushroom Mushroom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CULTIVATED MUSHROOM .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-1464_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1464 HUMAN PRESCRIPTION DRUG Mushroom Mushroom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CULTIVATED MUSHROOM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-1465_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1465 HUMAN PRESCRIPTION DRUG Mushroom Mushroom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CULTIVATED MUSHROOM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-1466_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1466 HUMAN PRESCRIPTION DRUG Black Olive Black Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK OLIVE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1467_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1467 HUMAN PRESCRIPTION DRUG Black Olive Black Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK OLIVE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1468_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1468 HUMAN PRESCRIPTION DRUG Black Olive Black Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK OLIVE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1469_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1469 HUMAN PRESCRIPTION DRUG Black Olive Black Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK OLIVE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1470_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1470 HUMAN PRESCRIPTION DRUG Green Olive Green Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GREEN OLIVE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1471_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1471 HUMAN PRESCRIPTION DRUG Green Olive Green Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GREEN OLIVE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1472_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1472 HUMAN PRESCRIPTION DRUG Green Olive Green Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GREEN OLIVE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1473_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1473 HUMAN PRESCRIPTION DRUG Green Olive Green Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GREEN OLIVE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1474_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1474 HUMAN PRESCRIPTION DRUG Yellow Onion Yellow Onion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ONION .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1475_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1475 HUMAN PRESCRIPTION DRUG Yellow Onion Yellow Onion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ONION .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1476_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1476 HUMAN PRESCRIPTION DRUG Yellow Onion Yellow Onion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ONION .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1477_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1477 HUMAN PRESCRIPTION DRUG Yellow Onion Yellow Onion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ONION .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1478_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1478 HUMAN PRESCRIPTION DRUG Parsley Parsley INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PARSLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1479_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1479 HUMAN PRESCRIPTION DRUG Parsley Parsley INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PARSLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1480_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1480 HUMAN PRESCRIPTION DRUG Parsley Parsley INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PARSLEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1481_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1481 HUMAN PRESCRIPTION DRUG Parsley Parsley INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PARSLEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1482_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1482 HUMAN PRESCRIPTION DRUG Green Pea Green Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1483_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1483 HUMAN PRESCRIPTION DRUG Green Pea Green Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1484_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1484 HUMAN PRESCRIPTION DRUG Green Pea Green Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1485_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1485 HUMAN PRESCRIPTION DRUG Green Pea Green Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1486_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1486 HUMAN PRESCRIPTION DRUG Sweet Potato Sweet Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SWEET POTATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1487_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1487 HUMAN PRESCRIPTION DRUG Sweet Potato Sweet Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SWEET POTATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1488_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1488 HUMAN PRESCRIPTION DRUG Sweet Potato Sweet Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SWEET POTATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1489_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1489 HUMAN PRESCRIPTION DRUG Sweet Potato Sweet Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SWEET POTATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1490_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1490 HUMAN PRESCRIPTION DRUG White Potato White Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POTATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1491_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1491 HUMAN PRESCRIPTION DRUG White Potato White Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POTATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1492_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1492 HUMAN PRESCRIPTION DRUG White Potato White Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POTATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1493_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1493 HUMAN PRESCRIPTION DRUG White Potato White Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POTATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1494_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1494 HUMAN PRESCRIPTION DRUG Pumpkin Pumpkin INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- PUMPKIN CUCURBITA PEPO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1495_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1495 HUMAN PRESCRIPTION DRUG Pumpkin Pumpkin INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- PUMPKIN CUCURBITA PEPO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1496_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1496 HUMAN PRESCRIPTION DRUG Pumpkin Pumpkin INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- PUMPKIN CUCURBITA PEPO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1497_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1497 HUMAN PRESCRIPTION DRUG Pumpkin Pumpkin INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- PUMPKIN CUCURBITA PEPO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1498_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1498 HUMAN PRESCRIPTION DRUG Radish Radish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RAPHANUS SATIVUS .05 g/mL 36987-1499_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1499 HUMAN PRESCRIPTION DRUG Radish Radish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RAPHANUS SATIVUS .05 g/mL 36987-1500_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1500 HUMAN PRESCRIPTION DRUG Radish Radish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RAPHANUS SATIVUS .1 g/mL 36987-1501_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1501 HUMAN PRESCRIPTION DRUG Radish Radish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RAPHANUS SATIVUS .1 g/mL 36987-1502_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1502 HUMAN PRESCRIPTION DRUG Rhubarb Rhubarb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHUBARB .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1503_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1503 HUMAN PRESCRIPTION DRUG Rhubarb Rhubarb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHUBARB .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1504_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1504 HUMAN PRESCRIPTION DRUG Rhubarb Rhubarb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHUBARB .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1505_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1505 HUMAN PRESCRIPTION DRUG Rhubarb Rhubarb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHUBARB .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1506_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1506 HUMAN PRESCRIPTION DRUG Soybean Soybean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOYBEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1507_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1507 HUMAN PRESCRIPTION DRUG Soybean Soybean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOYBEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1508_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1508 HUMAN PRESCRIPTION DRUG Soybean Soybean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOYBEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1509_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1509 HUMAN PRESCRIPTION DRUG Soybean Soybean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOYBEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1510_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1510 HUMAN PRESCRIPTION DRUG Spinach Spinach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SPINACH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1511_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1511 HUMAN PRESCRIPTION DRUG Spinach Spinach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SPINACH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1512_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1512 HUMAN PRESCRIPTION DRUG Spinach Spinach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SPINACH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1513_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1513 HUMAN PRESCRIPTION DRUG Spinach Spinach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SPINACH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1514_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1514 HUMAN PRESCRIPTION DRUG Squash Zucchini Squash Zucchini INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SQUASH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1515_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1515 HUMAN PRESCRIPTION DRUG Squash Zucchini Squash Zucchini INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SQUASH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1516_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1516 HUMAN PRESCRIPTION DRUG Squash Zucchini Squash Zucchini INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SQUASH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1517_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1517 HUMAN PRESCRIPTION DRUG Squash Zucchini Squash Zucchini INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SQUASH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1518_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1518 HUMAN PRESCRIPTION DRUG Tomato Tomato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOMATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1519_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1519 HUMAN PRESCRIPTION DRUG Tomato Tomato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOMATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1520_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1520 HUMAN PRESCRIPTION DRUG Tomato Tomato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOMATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1521_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1521 HUMAN PRESCRIPTION DRUG Tomato Tomato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOMATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1522_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1522 HUMAN PRESCRIPTION DRUG Turnip Turnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TURNIP .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1523_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1523 HUMAN PRESCRIPTION DRUG Turnip Turnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TURNIP .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1524_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1524 HUMAN PRESCRIPTION DRUG Turnip Turnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TURNIP .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1525_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1525 HUMAN PRESCRIPTION DRUG Turnip Turnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TURNIP .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1526_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1526 HUMAN PRESCRIPTION DRUG Almond Almond INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALMOND .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1527_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1527 HUMAN PRESCRIPTION DRUG Almond Almond INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALMOND .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1528_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1528 HUMAN PRESCRIPTION DRUG Almond Almond INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALMOND .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1529_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1529 HUMAN PRESCRIPTION DRUG Almond Almond INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALMOND .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1530_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1530 HUMAN PRESCRIPTION DRUG Brazil Nut Brazil Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BRAZIL NUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1531_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1531 HUMAN PRESCRIPTION DRUG Brazil Nut Brazil Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BRAZIL NUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1532_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1532 HUMAN PRESCRIPTION DRUG Brazil Nut Brazil Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BRAZIL NUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1533_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1533 HUMAN PRESCRIPTION DRUG Brazil Nut Brazil Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BRAZIL NUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1534_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1534 HUMAN PRESCRIPTION DRUG Cashew Cashew INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASHEW .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1535_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1535 HUMAN PRESCRIPTION DRUG Cashew Cashew INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASHEW .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1536_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1536 HUMAN PRESCRIPTION DRUG Cashew Cashew INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASHEW .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1537_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1537 HUMAN PRESCRIPTION DRUG Cashew Cashew INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASHEW .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1538_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1538 HUMAN PRESCRIPTION DRUG Coconut Coconut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCONUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1539_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1539 HUMAN PRESCRIPTION DRUG Coconut Coconut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCONUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1540_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1540 HUMAN PRESCRIPTION DRUG Coconut Coconut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCONUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1541_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1541 HUMAN PRESCRIPTION DRUG Coconut Coconut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCONUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1542_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1542 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ENGLISH WALNUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1543_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1543 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ENGLISH WALNUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1544_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1544 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ENGLISH WALNUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1545_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1545 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ENGLISH WALNUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1546_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1546 HUMAN PRESCRIPTION DRUG Filbert Filbert INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HAZELNUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1547_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1547 HUMAN PRESCRIPTION DRUG Filbert Filbert INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HAZELNUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1548_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1548 HUMAN PRESCRIPTION DRUG Filbert Filbert INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HAZELNUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1549_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1549 HUMAN PRESCRIPTION DRUG Filbert Filbert INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HAZELNUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1550_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1550 HUMAN PRESCRIPTION DRUG Peanut Peanut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEANUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1551_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1551 HUMAN PRESCRIPTION DRUG Peanut Peanut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEANUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1552_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1552 HUMAN PRESCRIPTION DRUG Peanut Peanut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEANUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1553_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1553 HUMAN PRESCRIPTION DRUG Peanut Peanut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEANUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1554_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1554 HUMAN PRESCRIPTION DRUG Pecan Nut Pecan Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PECAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1555_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1555 HUMAN PRESCRIPTION DRUG Pecan Nut Pecan Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PECAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1556_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1556 HUMAN PRESCRIPTION DRUG Pecan Nut Pecan Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PECAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1557_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1557 HUMAN PRESCRIPTION DRUG Pecan Nut Pecan Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PECAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1558_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1558 HUMAN PRESCRIPTION DRUG Pistachio Pistachio INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PISTACHIO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1559_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1559 HUMAN PRESCRIPTION DRUG Pistachio Pistachio INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PISTACHIO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1560_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1560 HUMAN PRESCRIPTION DRUG Pistachio Pistachio INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PISTACHIO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1561_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1561 HUMAN PRESCRIPTION DRUG Pistachio Pistachio INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PISTACHIO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1562_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1562 HUMAN PRESCRIPTION DRUG Barley Grain Barley Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BARLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1563_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1563 HUMAN PRESCRIPTION DRUG Barley Grain Barley Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BARLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1564_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1564 HUMAN PRESCRIPTION DRUG Barley Grain Barley Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BARLEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1565_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1565 HUMAN PRESCRIPTION DRUG Barley Grain Barley Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BARLEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1566_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1566 HUMAN PRESCRIPTION DRUG Buckwheat Grain Buckwheat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BUCKWHEAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1567_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1567 HUMAN PRESCRIPTION DRUG Buckwheat Grain Buckwheat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BUCKWHEAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1568_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1568 HUMAN PRESCRIPTION DRUG Buckwheat Grain Buckwheat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BUCKWHEAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1569_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1569 HUMAN PRESCRIPTION DRUG Buckwheat Grain Buckwheat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BUCKWHEAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1570_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1570 HUMAN PRESCRIPTION DRUG Oat Grain Oat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1571_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1571 HUMAN PRESCRIPTION DRUG Oat Grain Oat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1572_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1572 HUMAN PRESCRIPTION DRUG Oat Grain Oat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1573_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1573 HUMAN PRESCRIPTION DRUG Oat Grain Oat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1574_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1574 HUMAN PRESCRIPTION DRUG Rice Grain Rice Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RICE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1575_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1575 HUMAN PRESCRIPTION DRUG Rice Grain Rice Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RICE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1576_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1576 HUMAN PRESCRIPTION DRUG Rice Grain Rice Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RICE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1577_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1577 HUMAN PRESCRIPTION DRUG Rice Grain Rice Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RICE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1578_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1578 HUMAN PRESCRIPTION DRUG Rye Grain Rye Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RYE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1579_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1579 HUMAN PRESCRIPTION DRUG Rye Grain Rye Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RYE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1580_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1580 HUMAN PRESCRIPTION DRUG Rye Grain Rye Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RYE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1581_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1581 HUMAN PRESCRIPTION DRUG Rye Grain Rye Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RYE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1582_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1582 HUMAN PRESCRIPTION DRUG Whole Wheat Grain Whole Wheat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHEAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1583_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1583 HUMAN PRESCRIPTION DRUG Whole Wheat Grain Whole Wheat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHEAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1584_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1584 HUMAN PRESCRIPTION DRUG Whole Wheat Grain Whole Wheat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHEAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1585_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1585 HUMAN PRESCRIPTION DRUG Whole Wheat Grain Whole Wheat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHEAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1586_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1586 HUMAN PRESCRIPTION DRUG Macadamia Nut Macadamia Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MACADAMIA NUT .05 g/mL 36987-1587_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1587 HUMAN PRESCRIPTION DRUG Macadamia Nut Macadamia Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MACADAMIA NUT .05 g/mL 36987-1588_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1588 HUMAN PRESCRIPTION DRUG Macadamia Nut Macadamia Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MACADAMIA NUT .1 g/mL 36987-1589_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1589 HUMAN PRESCRIPTION DRUG Macadamia Nut Macadamia Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MACADAMIA NUT .1 g/mL 36987-1590_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1590 HUMAN PRESCRIPTION DRUG Nectarine Nectarine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NECTARINE .05 g/mL 36987-1591_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1591 HUMAN PRESCRIPTION DRUG Nectarine Nectarine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NECTARINE .05 g/mL 36987-1592_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1592 HUMAN PRESCRIPTION DRUG Nectarine Nectarine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NECTARINE .1 g/mL 36987-1593_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1593 HUMAN PRESCRIPTION DRUG Nectarine Nectarine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NECTARINE .1 g/mL 36987-1594_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1594 HUMAN PRESCRIPTION DRUG Mango Mango INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1595_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1595 HUMAN PRESCRIPTION DRUG Mango Mango INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1596_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1596 HUMAN PRESCRIPTION DRUG Mango Mango INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1597_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1597 HUMAN PRESCRIPTION DRUG Mango Mango INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1598_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1598 HUMAN PRESCRIPTION DRUG Papaya Papaya INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PAPAYA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1599_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1599 HUMAN PRESCRIPTION DRUG Papaya Papaya INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PAPAYA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1600_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1600 HUMAN PRESCRIPTION DRUG Papaya Papaya INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PAPAYA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1601_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1601 HUMAN PRESCRIPTION DRUG Papaya Papaya INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PAPAYA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 36987-1602_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1602 HUMAN PRESCRIPTION DRUG Leeks Leeks INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEEK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1603_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1603 HUMAN PRESCRIPTION DRUG Leeks Leeks INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEEK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1604_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1604 HUMAN PRESCRIPTION DRUG Leeks Leeks INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEEK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1605_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1605 HUMAN PRESCRIPTION DRUG Leeks Leeks INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEEK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1606_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1606 HUMAN PRESCRIPTION DRUG Okra Okra INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OKRA .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1607_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1607 HUMAN PRESCRIPTION DRUG Okra Okra INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OKRA .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1608_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1608 HUMAN PRESCRIPTION DRUG Okra Okra INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OKRA .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1609_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1609 HUMAN PRESCRIPTION DRUG Okra Okra INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OKRA .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1610_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1610 HUMAN PRESCRIPTION DRUG Parsnip Parsnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PARSNIP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1611_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1611 HUMAN PRESCRIPTION DRUG Parsnip Parsnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PARSNIP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1612_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1612 HUMAN PRESCRIPTION DRUG Parsnip Parsnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PARSNIP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1613_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1613 HUMAN PRESCRIPTION DRUG Parsnip Parsnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PARSNIP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1614_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1614 HUMAN PRESCRIPTION DRUG Chick Pea Chick Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHICKPEA .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1615_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1615 HUMAN PRESCRIPTION DRUG Chick Pea Chick Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHICKPEA .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1616_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1616 HUMAN PRESCRIPTION DRUG Chick Pea Chick Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHICKPEA .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1617_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1617 HUMAN PRESCRIPTION DRUG Chick Pea Chick Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHICKPEA .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1618_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1618 HUMAN PRESCRIPTION DRUG Blackeye Pea Blackeye Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK-EYED PEA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 36987-1619_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1619 HUMAN PRESCRIPTION DRUG Blackeye Pea Blackeye Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK-EYED PEA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 36987-1620_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1620 HUMAN PRESCRIPTION DRUG Blackeye Pea Blackeye Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK-EYED PEA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 36987-1621_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1621 HUMAN PRESCRIPTION DRUG Blackeye Pea Blackeye Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK-EYED PEA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 36987-1622_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1622 HUMAN PRESCRIPTION DRUG Watercress Watercress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WATERCRESS .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1623_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1623 HUMAN PRESCRIPTION DRUG Watercress Watercress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WATERCRESS .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1624_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1624 HUMAN PRESCRIPTION DRUG Watercress Watercress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WATERCRESS .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1625_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1625 HUMAN PRESCRIPTION DRUG Watercress Watercress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WATERCRESS .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1626_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1626 HUMAN PRESCRIPTION DRUG Corn Grain Corn Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1627_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1627 HUMAN PRESCRIPTION DRUG Corn Grain Corn Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1628_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1628 HUMAN PRESCRIPTION DRUG Corn Grain Corn Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1629_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1629 HUMAN PRESCRIPTION DRUG Corn Grain Corn Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1630_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1630 HUMAN PRESCRIPTION DRUG Cacao Bean Cacao Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHOCOLATE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1631_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1631 HUMAN PRESCRIPTION DRUG Cacao Bean Cacao Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHOCOLATE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1632_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1632 HUMAN PRESCRIPTION DRUG Cacao Bean Cacao Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHOCOLATE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1633_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1633 HUMAN PRESCRIPTION DRUG Cacao Bean Cacao Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHOCOLATE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1634_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1634 HUMAN PRESCRIPTION DRUG Coffee Coffee INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARABICA COFFEE BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1635_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1635 HUMAN PRESCRIPTION DRUG Coffee Coffee INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARABICA COFFEE BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1636_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1636 HUMAN PRESCRIPTION DRUG Coffee Coffee INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARABICA COFFEE BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1637_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1637 HUMAN PRESCRIPTION DRUG Coffee Coffee INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARABICA COFFEE BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1638_d776fd84-c01f-4483-9146-5d715e675716 36987-1638 HUMAN PRESCRIPTION DRUG Arabic Gum Arabic Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA .005 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1640_d776fd84-c01f-4483-9146-5d715e675716 36987-1640 HUMAN PRESCRIPTION DRUG Arabic Gum Arabic Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA .01 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1642_d776fd84-c01f-4483-9146-5d715e675716 36987-1642 HUMAN PRESCRIPTION DRUG Karaya Gum Karaya Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KARAYA GUM .005 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1644_d776fd84-c01f-4483-9146-5d715e675716 36987-1644 HUMAN PRESCRIPTION DRUG Karaya Gum Karaya Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KARAYA GUM .01 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1646_d776fd84-c01f-4483-9146-5d715e675716 36987-1646 HUMAN PRESCRIPTION DRUG Tragacanth Gum Tragacanth Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRAGACANTH .005 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1648_d776fd84-c01f-4483-9146-5d715e675716 36987-1648 HUMAN PRESCRIPTION DRUG Tragacanth Gum Tragacanth Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRAGACANTH .01 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1650_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1650 HUMAN PRESCRIPTION DRUG Malt Malt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MALT EXTRACT, BARLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1651_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1651 HUMAN PRESCRIPTION DRUG Malt Malt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MALT EXTRACT, BARLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1652_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1652 HUMAN PRESCRIPTION DRUG Malt Malt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MALT EXTRACT, BARLEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1653_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1653 HUMAN PRESCRIPTION DRUG Malt Malt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MALT EXTRACT, BARLEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 36987-1654_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1654 HUMAN PRESCRIPTION DRUG Orange Pekoe Tea Orange Pekoe Tea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TEA LEAF .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1655_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1655 HUMAN PRESCRIPTION DRUG Orange Pekoe Tea Orange Pekoe Tea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TEA LEAF .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1656_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1656 HUMAN PRESCRIPTION DRUG Orange Pekoe Tea Orange Pekoe Tea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TEA LEAF .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1657_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1657 HUMAN PRESCRIPTION DRUG Orange Pekoe Tea Orange Pekoe Tea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TEA LEAF .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1658_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1658 HUMAN PRESCRIPTION DRUG Brewers Yeast Brewers Yeast INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-1659_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1659 HUMAN PRESCRIPTION DRUG Brewers Yeast Brewers Yeast INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-1660_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1660 HUMAN PRESCRIPTION DRUG Brewers Yeast Brewers Yeast INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-1661_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1661 HUMAN PRESCRIPTION DRUG Brewers Yeast Brewers Yeast INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-1662_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1662 HUMAN PRESCRIPTION DRUG Allspice Allspice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLSPICE .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1663_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1663 HUMAN PRESCRIPTION DRUG Allspice Allspice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLSPICE .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1664_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1664 HUMAN PRESCRIPTION DRUG Allspice Allspice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLSPICE .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1665_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1665 HUMAN PRESCRIPTION DRUG Allspice Allspice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLSPICE .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1666_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1666 HUMAN PRESCRIPTION DRUG Bay Leaf Bay Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LAURUS NOBILIS .05 g/mL 36987-1667_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1667 HUMAN PRESCRIPTION DRUG Bay Leaf Bay Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LAURUS NOBILIS .05 g/mL 36987-1668_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1668 HUMAN PRESCRIPTION DRUG Bay Leaf Bay Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LAURUS NOBILIS .1 g/mL 36987-1669_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1669 HUMAN PRESCRIPTION DRUG Bay Leaf Bay Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LAURUS NOBILIS .1 g/mL 36987-1670_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1670 HUMAN PRESCRIPTION DRUG Caraway Seed Caraway Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARAWAY SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1671_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1671 HUMAN PRESCRIPTION DRUG Caraway Seed Caraway Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARAWAY SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1672_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1672 HUMAN PRESCRIPTION DRUG Caraway Seed Caraway Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARAWAY SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1673_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1673 HUMAN PRESCRIPTION DRUG Caraway Seed Caraway Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARAWAY SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1674_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1674 HUMAN PRESCRIPTION DRUG Cinnamon Cinnamon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CINNAMON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1675_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1675 HUMAN PRESCRIPTION DRUG Cinnamon Cinnamon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CINNAMON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1676_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1676 HUMAN PRESCRIPTION DRUG Cinnamon Cinnamon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CINNAMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1677_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1677 HUMAN PRESCRIPTION DRUG Cinnamon Cinnamon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CINNAMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1678_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1678 HUMAN PRESCRIPTION DRUG Cloves Cloves INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLOVE .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1679_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1679 HUMAN PRESCRIPTION DRUG Cloves Cloves INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLOVE .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1680_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1680 HUMAN PRESCRIPTION DRUG Cloves Cloves INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLOVE .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1681_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1681 HUMAN PRESCRIPTION DRUG Cloves Cloves INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLOVE .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1686_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1686 HUMAN PRESCRIPTION DRUG Dill Dill INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DILL .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1687_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1687 HUMAN PRESCRIPTION DRUG Dill Dill INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DILL .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1688_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1688 HUMAN PRESCRIPTION DRUG Dill Dill INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DILL .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1689_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1689 HUMAN PRESCRIPTION DRUG Dill Dill INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DILL .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1690_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1690 HUMAN PRESCRIPTION DRUG Garlic Garlic INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GARLIC .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1691_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1691 HUMAN PRESCRIPTION DRUG Garlic Garlic INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GARLIC .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1692_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1692 HUMAN PRESCRIPTION DRUG Garlic Garlic INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GARLIC .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1693_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1693 HUMAN PRESCRIPTION DRUG Garlic Garlic INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GARLIC .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1694_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1694 HUMAN PRESCRIPTION DRUG Ginger Ginger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GINGER .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1695_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1695 HUMAN PRESCRIPTION DRUG Ginger Ginger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GINGER .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1696_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1696 HUMAN PRESCRIPTION DRUG Ginger Ginger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GINGER .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1697_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1697 HUMAN PRESCRIPTION DRUG Ginger Ginger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GINGER .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1698_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1698 HUMAN PRESCRIPTION DRUG Horseradish Horseradish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HORSERADISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1699_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1699 HUMAN PRESCRIPTION DRUG Horseradish Horseradish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HORSERADISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1700_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1700 HUMAN PRESCRIPTION DRUG Horseradish Horseradish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HORSERADISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1701_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1701 HUMAN PRESCRIPTION DRUG Horseradish Horseradish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HORSERADISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1702_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1702 HUMAN PRESCRIPTION DRUG Licorice Licorice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LICORICE .05 g/mL 36987-1703_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1703 HUMAN PRESCRIPTION DRUG Licorice Licorice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LICORICE .05 g/mL 36987-1704_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1704 HUMAN PRESCRIPTION DRUG Licorice Licorice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LICORICE .1 g/mL 36987-1705_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1705 HUMAN PRESCRIPTION DRUG Licorice Licorice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LICORICE .1 g/mL 36987-1706_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1706 HUMAN PRESCRIPTION DRUG Mustard Seed Mustard Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSTARD SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1707_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1707 HUMAN PRESCRIPTION DRUG Mustard Seed Mustard Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSTARD SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1708_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1708 HUMAN PRESCRIPTION DRUG Mustard Seed Mustard Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSTARD SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1709_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1709 HUMAN PRESCRIPTION DRUG Mustard Seed Mustard Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSTARD SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1710_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1710 HUMAN PRESCRIPTION DRUG Nutmeg Nutmeg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NUTMEG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1711_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1711 HUMAN PRESCRIPTION DRUG Nutmeg Nutmeg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NUTMEG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1712_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1712 HUMAN PRESCRIPTION DRUG Nutmeg Nutmeg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NUTMEG .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1713_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1713 HUMAN PRESCRIPTION DRUG Nutmeg Nutmeg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NUTMEG .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1714_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1714 HUMAN PRESCRIPTION DRUG Oregano Oregano INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OREGANO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1715_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1715 HUMAN PRESCRIPTION DRUG Oregano Oregano INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OREGANO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1716_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1716 HUMAN PRESCRIPTION DRUG Oregano Oregano INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OREGANO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1717_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1717 HUMAN PRESCRIPTION DRUG Oregano Oregano INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OREGANO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1718_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1718 HUMAN PRESCRIPTION DRUG Paprika Paprika INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PAPRIKA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1719_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1719 HUMAN PRESCRIPTION DRUG Paprika Paprika INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PAPRIKA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1720_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1720 HUMAN PRESCRIPTION DRUG Paprika Paprika INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PAPRIKA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1721_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1721 HUMAN PRESCRIPTION DRUG Paprika Paprika INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PAPRIKA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1722_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1722 HUMAN PRESCRIPTION DRUG White Pepper White Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHITE PEPPER .05 g/mL 36987-1723_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1723 HUMAN PRESCRIPTION DRUG White Pepper White Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHITE PEPPER .05 g/mL 36987-1724_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1724 HUMAN PRESCRIPTION DRUG White Pepper White Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHITE PEPPER .1 g/mL 36987-1725_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1725 HUMAN PRESCRIPTION DRUG White Pepper White Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHITE PEPPER .1 g/mL 36987-1726_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1726 HUMAN PRESCRIPTION DRUG Peppermint Peppermint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEPPERMINT FLOWERING TOP .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1727_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1727 HUMAN PRESCRIPTION DRUG Peppermint Peppermint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEPPERMINT FLOWERING TOP .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1728_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1728 HUMAN PRESCRIPTION DRUG Peppermint Peppermint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEPPERMINT FLOWERING TOP .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1729_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1729 HUMAN PRESCRIPTION DRUG Peppermint Peppermint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEPPERMINT FLOWERING TOP .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1730_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1730 HUMAN PRESCRIPTION DRUG Poppyseed Poppyseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPPY SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1731_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1731 HUMAN PRESCRIPTION DRUG Poppyseed Poppyseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPPY SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1732_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1732 HUMAN PRESCRIPTION DRUG Poppyseed Poppyseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPPY SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1733_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1733 HUMAN PRESCRIPTION DRUG Poppyseed Poppyseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPPY SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-1734_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1734 HUMAN PRESCRIPTION DRUG Sage Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALVIA OFFICINALIS .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1735_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1735 HUMAN PRESCRIPTION DRUG Sage Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALVIA OFFICINALIS .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1736_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1736 HUMAN PRESCRIPTION DRUG Sage Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALVIA OFFICINALIS .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1737_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1737 HUMAN PRESCRIPTION DRUG Sage Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALVIA OFFICINALIS .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1738_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1738 HUMAN PRESCRIPTION DRUG Sesame Sesame INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SESAME SEED .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1739_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1739 HUMAN PRESCRIPTION DRUG Sesame Sesame INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SESAME SEED .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1740_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1740 HUMAN PRESCRIPTION DRUG Sesame Sesame INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SESAME SEED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1741_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1741 HUMAN PRESCRIPTION DRUG Sesame Sesame INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SESAME SEED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-1742_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1742 HUMAN PRESCRIPTION DRUG Spearmint Spearmint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SPEARMINT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 36987-1743_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1743 HUMAN PRESCRIPTION DRUG Spearmint Spearmint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SPEARMINT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 36987-1744_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1744 HUMAN PRESCRIPTION DRUG Spearmint Spearmint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SPEARMINT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 36987-1745_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1745 HUMAN PRESCRIPTION DRUG Spearmint Spearmint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SPEARMINT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 36987-1746_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1746 HUMAN PRESCRIPTION DRUG Thyme Thym INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GARDEN THYME .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1747_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1747 HUMAN PRESCRIPTION DRUG Thyme Thym INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GARDEN THYME .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1748_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1748 HUMAN PRESCRIPTION DRUG Thyme Thym INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GARDEN THYME .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1749_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1749 HUMAN PRESCRIPTION DRUG Thyme Thym INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GARDEN THYME .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1750_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1750 HUMAN PRESCRIPTION DRUG Vanilla Vanilla INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. VANILLA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1751_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1751 HUMAN PRESCRIPTION DRUG Vanilla Vanilla INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. VANILLA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1752_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1752 HUMAN PRESCRIPTION DRUG Vanilla Vanilla INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. VANILLA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1753_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1753 HUMAN PRESCRIPTION DRUG Vanilla Vanilla INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. VANILLA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1754_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1754 HUMAN PRESCRIPTION DRUG Wheat Bran Wheat Bran INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHEAT BRAN .05 g/mL 36987-1755_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1755 HUMAN PRESCRIPTION DRUG Wheat Bran Wheat Bran INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHEAT BRAN .05 g/mL 36987-1756_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1756 HUMAN PRESCRIPTION DRUG Wheat Bran Wheat Bran INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHEAT BRAN .1 g/mL 36987-1757_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1757 HUMAN PRESCRIPTION DRUG Wheat Bran Wheat Bran INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHEAT BRAN .1 g/mL 36987-1758_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1758 HUMAN PRESCRIPTION DRUG White Kidney Beans White Kidney Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1759_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1759 HUMAN PRESCRIPTION DRUG White Kidney Beans White Kidney Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1760_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1760 HUMAN PRESCRIPTION DRUG White Kidney Beans White Kidney Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1761_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1761 HUMAN PRESCRIPTION DRUG White Kidney Beans White Kidney Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1766_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1766 HUMAN PRESCRIPTION DRUG Black Pepper Black Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK PEPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1767_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1767 HUMAN PRESCRIPTION DRUG Black Pepper Black Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK PEPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1768_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1768 HUMAN PRESCRIPTION DRUG Black Pepper Black Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK PEPPER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1769_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1769 HUMAN PRESCRIPTION DRUG Black Pepper Black Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK PEPPER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 36987-1770_a0de52d8-af70-4f43-8468-3b7a42072d2f 36987-1770 HUMAN PRESCRIPTION DRUG Chestnut Chestnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMERICAN CHESTNUT .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1771_b82c13c6-5ea4-422b-9aaf-fffe61a501d6 36987-1771 HUMAN PRESCRIPTION DRUG Chestnut Chestnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMERICAN CHESTNUT .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1772_274649f0-2ad5-4bfe-a4b1-f79e1155293a 36987-1772 HUMAN PRESCRIPTION DRUG Chestnut Chestnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMERICAN CHESTNUT .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1773_a99f08f8-155a-4bb9-a56b-0f5c78144a19 36987-1773 HUMAN PRESCRIPTION DRUG Chestnut Chestnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMERICAN CHESTNUT .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 36987-1774_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1774 HUMAN PRESCRIPTION DRUG Hops Hops INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOPS .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1775_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1775 HUMAN PRESCRIPTION DRUG Hops Hops INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOPS .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1776_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1776 HUMAN PRESCRIPTION DRUG Hops Hops INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOPS .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1777_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1777 HUMAN PRESCRIPTION DRUG Hops Hops INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOPS .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 36987-1778_72ccd3a1-bbd2-46cc-8bb6-970a8a2f1874 36987-1778 HUMAN PRESCRIPTION DRUG Fire Ant Fire Ant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLENOPSIS INVICTA 10000 [PNU]/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1779_f243b580-e924-4bc5-9214-b3dfdf50a0a5 36987-1779 HUMAN PRESCRIPTION DRUG Fire Ant Fire Ant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLENOPSIS INVICTA 10000 [PNU]/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1780_5a479ad2-b047-43df-a87a-e6d227a0ca2f 36987-1780 HUMAN PRESCRIPTION DRUG Fire Ant Fire Ant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLENOPSIS INVICTA 20000 [PNU]/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1781_b867c176-bd24-4801-a83d-6ffe9619374a 36987-1781 HUMAN PRESCRIPTION DRUG Fire Ant Fire Ant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLENOPSIS INVICTA 20000 [PNU]/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1782_0dfdf82e-c929-42cd-8393-5392bfe2ea7c 36987-1782 HUMAN PRESCRIPTION DRUG Fire Ant Fire Ant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLENOPSIS INVICTA .05 g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1783_134fa1e6-4218-4138-b3e8-50dbbbe2e42a 36987-1783 HUMAN PRESCRIPTION DRUG Fire Ant Fire Ant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLENOPSIS INVICTA .05 g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1784_c78e08bb-dbe9-40a7-92d5-c9c5d0403765 36987-1784 HUMAN PRESCRIPTION DRUG Fire Ant Fire Ant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLENOPSIS INVICTA .1 g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1785_cb84ead7-2044-4cda-8f02-0da04fa5fff4 36987-1785 HUMAN PRESCRIPTION DRUG Fire Ant Fire Ant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLENOPSIS INVICTA .1 g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1786_72ccd3a1-bbd2-46cc-8bb6-970a8a2f1874 36987-1786 HUMAN PRESCRIPTION DRUG House Fly House Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1787_f243b580-e924-4bc5-9214-b3dfdf50a0a5 36987-1787 HUMAN PRESCRIPTION DRUG House Fly House Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1788_5a479ad2-b047-43df-a87a-e6d227a0ca2f 36987-1788 HUMAN PRESCRIPTION DRUG House Fly House Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1789_b867c176-bd24-4801-a83d-6ffe9619374a 36987-1789 HUMAN PRESCRIPTION DRUG House Fly House Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1790_0dfdf82e-c929-42cd-8393-5392bfe2ea7c 36987-1790 HUMAN PRESCRIPTION DRUG House Fly House Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1791_134fa1e6-4218-4138-b3e8-50dbbbe2e42a 36987-1791 HUMAN PRESCRIPTION DRUG House Fly House Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1792_c78e08bb-dbe9-40a7-92d5-c9c5d0403765 36987-1792 HUMAN PRESCRIPTION DRUG House Fly House Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1793_cb84ead7-2044-4cda-8f02-0da04fa5fff4 36987-1793 HUMAN PRESCRIPTION DRUG House Fly House Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1794_72ccd3a1-bbd2-46cc-8bb6-970a8a2f1874 36987-1794 HUMAN PRESCRIPTION DRUG Cockroach American Cockroach American INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1795_f243b580-e924-4bc5-9214-b3dfdf50a0a5 36987-1795 HUMAN PRESCRIPTION DRUG Cockroach American Cockroach American INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1796_5a479ad2-b047-43df-a87a-e6d227a0ca2f 36987-1796 HUMAN PRESCRIPTION DRUG Cockroach American Cockroach American INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1797_b867c176-bd24-4801-a83d-6ffe9619374a 36987-1797 HUMAN PRESCRIPTION DRUG Cockroach American Cockroach American INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1798_0dfdf82e-c929-42cd-8393-5392bfe2ea7c 36987-1798 HUMAN PRESCRIPTION DRUG Cockroach American Cockroach American INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1799_134fa1e6-4218-4138-b3e8-50dbbbe2e42a 36987-1799 HUMAN PRESCRIPTION DRUG Cockroach American Cockroach American INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1800_c78e08bb-dbe9-40a7-92d5-c9c5d0403765 36987-1800 HUMAN PRESCRIPTION DRUG Cockroach American Cockroach American INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1801_cb84ead7-2044-4cda-8f02-0da04fa5fff4 36987-1801 HUMAN PRESCRIPTION DRUG Cockroach American Cockroach American INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1802_d776fd84-c01f-4483-9146-5d715e675716 36987-1802 HUMAN PRESCRIPTION DRUG Dog Flea Dog Flea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CTENOCEPHALIDES CANIS .01 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1803_d776fd84-c01f-4483-9146-5d715e675716 36987-1803 HUMAN PRESCRIPTION DRUG Dog Flea Dog Flea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CTENOCEPHALIDES CANIS .01 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1804_72ccd3a1-bbd2-46cc-8bb6-970a8a2f1874 36987-1804 HUMAN PRESCRIPTION DRUG Horse Fly Horse Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1805_f243b580-e924-4bc5-9214-b3dfdf50a0a5 36987-1805 HUMAN PRESCRIPTION DRUG Horse Fly Horse Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1806_5a479ad2-b047-43df-a87a-e6d227a0ca2f 36987-1806 HUMAN PRESCRIPTION DRUG Horse Fly Horse Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1807_b867c176-bd24-4801-a83d-6ffe9619374a 36987-1807 HUMAN PRESCRIPTION DRUG Horse Fly Horse Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1808_0dfdf82e-c929-42cd-8393-5392bfe2ea7c 36987-1808 HUMAN PRESCRIPTION DRUG Horse Fly Horse Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1809_134fa1e6-4218-4138-b3e8-50dbbbe2e42a 36987-1809 HUMAN PRESCRIPTION DRUG Horse Fly Horse Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1810_c78e08bb-dbe9-40a7-92d5-c9c5d0403765 36987-1810 HUMAN PRESCRIPTION DRUG Horse Fly Horse Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1811_cb84ead7-2044-4cda-8f02-0da04fa5fff4 36987-1811 HUMAN PRESCRIPTION DRUG Horse Fly Horse Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1812_72ccd3a1-bbd2-46cc-8bb6-970a8a2f1874 36987-1812 HUMAN PRESCRIPTION DRUG Mosquito Mosquito INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AEDES TAENIORHYNCHUS 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1813_f243b580-e924-4bc5-9214-b3dfdf50a0a5 36987-1813 HUMAN PRESCRIPTION DRUG Mosquito Mosquito INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AEDES TAENIORHYNCHUS 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1814_5a479ad2-b047-43df-a87a-e6d227a0ca2f 36987-1814 HUMAN PRESCRIPTION DRUG Mosquito Mosquito INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AEDES TAENIORHYNCHUS 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1815_b867c176-bd24-4801-a83d-6ffe9619374a 36987-1815 HUMAN PRESCRIPTION DRUG Mosquito Mosquito INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AEDES TAENIORHYNCHUS 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1816_0dfdf82e-c929-42cd-8393-5392bfe2ea7c 36987-1816 HUMAN PRESCRIPTION DRUG Mosquito Mosquito INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AEDES TAENIORHYNCHUS .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1817_134fa1e6-4218-4138-b3e8-50dbbbe2e42a 36987-1817 HUMAN PRESCRIPTION DRUG Mosquito Mosquito INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AEDES TAENIORHYNCHUS .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1818_c78e08bb-dbe9-40a7-92d5-c9c5d0403765 36987-1818 HUMAN PRESCRIPTION DRUG Mosquito Mosquito INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AEDES TAENIORHYNCHUS .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1819_cb84ead7-2044-4cda-8f02-0da04fa5fff4 36987-1819 HUMAN PRESCRIPTION DRUG Mosquito Mosquito INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AEDES TAENIORHYNCHUS .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1836_72ccd3a1-bbd2-46cc-8bb6-970a8a2f1874 36987-1836 HUMAN PRESCRIPTION DRUG German Cockroach German Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1837_f243b580-e924-4bc5-9214-b3dfdf50a0a5 36987-1837 HUMAN PRESCRIPTION DRUG German Cockroach German Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1838_5a479ad2-b047-43df-a87a-e6d227a0ca2f 36987-1838 HUMAN PRESCRIPTION DRUG German Cockroach German Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1839_b867c176-bd24-4801-a83d-6ffe9619374a 36987-1839 HUMAN PRESCRIPTION DRUG German Cockroach German Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1840_0dfdf82e-c929-42cd-8393-5392bfe2ea7c 36987-1840 HUMAN PRESCRIPTION DRUG German Cockroach German Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1841_134fa1e6-4218-4138-b3e8-50dbbbe2e42a 36987-1841 HUMAN PRESCRIPTION DRUG German Cockroach German Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1842_c78e08bb-dbe9-40a7-92d5-c9c5d0403765 36987-1842 HUMAN PRESCRIPTION DRUG German Cockroach German Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1843_cb84ead7-2044-4cda-8f02-0da04fa5fff4 36987-1843 HUMAN PRESCRIPTION DRUG German Cockroach German Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1844_c8129b8e-5759-459a-bbc3-02830cadb059 36987-1844 HUMAN PRESCRIPTION DRUG Standardized Mite Dermatophagoides farinae Standardized Mite Dermatophagoides farinae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19870612 BLA BLA102193 Nelco Laboratories, Inc. DERMATOPHAGOIDES FARINAE 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1845_c8129b8e-5759-459a-bbc3-02830cadb059 36987-1845 HUMAN PRESCRIPTION DRUG Standardized Mite Dermatophagoides pteronyssinus Standardized Mite Dermatophagoides pteronyssinus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19900222 BLA BLA102194 Nelco Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1846_d776fd84-c01f-4483-9146-5d715e675716 36987-1846 HUMAN PRESCRIPTION DRUG Cat Flea Cat Flea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CTENOCEPHALIDES FELIS .01 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1847_d776fd84-c01f-4483-9146-5d715e675716 36987-1847 HUMAN PRESCRIPTION DRUG Cat Flea Cat Flea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CTENOCEPHALIDES FELIS .01 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1848_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1848 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1849_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1849 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1850_0dbb0652-e487-4678-a747-b379f75821dc 36987-1850 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1851_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1851 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1852_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1852 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1853_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1853 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1854_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1854 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1855_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1855 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1856_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1856 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1857_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1857 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1858_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1858 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1859_0dbb0652-e487-4678-a747-b379f75821dc 36987-1859 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1860_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1860 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1861_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1861 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1862_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1862 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1863_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1863 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1864_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1864 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1865_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1865 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1866_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1866 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1867_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1867 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1868_0dbb0652-e487-4678-a747-b379f75821dc 36987-1868 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1869_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1869 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1870_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1870 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1871_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1871 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1872_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1872 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1873_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1873 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1874_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1874 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1875_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1875 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1876_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1876 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1877_0dbb0652-e487-4678-a747-b379f75821dc 36987-1877 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1878_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1878 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1879_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1879 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1880_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1880 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1881_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1881 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1882_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1882 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1883_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1883 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1884_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1884 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1885_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1885 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1886_0dbb0652-e487-4678-a747-b379f75821dc 36987-1886 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1887_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1887 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1888_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1888 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1889_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1889 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1890_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1890 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1891_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1891 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1892_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1892 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1893_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1893 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1894_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1894 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1895_0dbb0652-e487-4678-a747-b379f75821dc 36987-1895 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1896_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1896 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1897_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1897 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1898_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1898 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1899_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1899 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1900_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1900 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1901_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1901 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1902_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1902 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1903_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1903 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1904_0dbb0652-e487-4678-a747-b379f75821dc 36987-1904 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1905_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1905 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1906_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1906 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1907_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1907 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1908_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1908 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1909_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1909 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1910_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1910 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1911_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1911 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS 10000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 36987-1912_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1912 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS 10000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 36987-1913_0dbb0652-e487-4678-a747-b379f75821dc 36987-1913 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS 20000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 36987-1914_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1914 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS 20000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 36987-1915_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1915 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS 40000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 36987-1916_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1916 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS .05 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 36987-1917_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1917 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS .05 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 36987-1918_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1918 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS .1 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 36987-1919_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1919 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS .1 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 36987-1920_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1920 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1921_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1921 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1922_0dbb0652-e487-4678-a747-b379f75821dc 36987-1922 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1923_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1923 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1924_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1924 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1925_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1925 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1926_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1926 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1927_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1927 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1928_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1928 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1929_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1929 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1930_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1930 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1931_0dbb0652-e487-4678-a747-b379f75821dc 36987-1931 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1932_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1932 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1933_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1933 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1934_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1934 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1935_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1935 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1936_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1936 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1937_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1937 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1938_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1938 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1939_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1939 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1940_0dbb0652-e487-4678-a747-b379f75821dc 36987-1940 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1941_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1941 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1942_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1942 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1943_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1943 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1944_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1944 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1945_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1945 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1946_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1946 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1947_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1947 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1948_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1948 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1949_0dbb0652-e487-4678-a747-b379f75821dc 36987-1949 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1950_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1950 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1951_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1951 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1952_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1952 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1953_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1953 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1954_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1954 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1955_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1955 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1956_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1956 HUMAN PRESCRIPTION DRUG Curvularia inequalis Curvularia inequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1957_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1957 HUMAN PRESCRIPTION DRUG Curvularia inequalis Curvularia inequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1958_0dbb0652-e487-4678-a747-b379f75821dc 36987-1958 HUMAN PRESCRIPTION DRUG Curvularia inequalis Curvularia inequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1959_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1959 HUMAN PRESCRIPTION DRUG Curvularia inequalis Curvularia inequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1960_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1960 HUMAN PRESCRIPTION DRUG Curvularia inaequalis Curvularia inaequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1961_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1961 HUMAN PRESCRIPTION DRUG Curvularia inequalis Curvularia inequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1962_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1962 HUMAN PRESCRIPTION DRUG Curvularia inequalis Curvularia inequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1963_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1963 HUMAN PRESCRIPTION DRUG Curvularia inequalis Curvularia inequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1964_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1964 HUMAN PRESCRIPTION DRUG Curvularia inequalis Curvularia inequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1965_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1965 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM 10000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-1966_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1966 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM 10000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-1967_0dbb0652-e487-4678-a747-b379f75821dc 36987-1967 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM 20000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-1968_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1968 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM 20000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-1969_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1969 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM 40000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-1970_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1970 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM .05 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-1971_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1971 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM .05 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-1972_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1972 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM .1 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-1973_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1973 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM .1 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-1974_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1974 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1975_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1975 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1976_0dbb0652-e487-4678-a747-b379f75821dc 36987-1976 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1977_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1977 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1978_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1978 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1979_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1979 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1980_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1980 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1981_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1981 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1982_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1982 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1983_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1983 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1984_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1984 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1985_0dbb0652-e487-4678-a747-b379f75821dc 36987-1985 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1986_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1986 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1987_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1987 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1988_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1988 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1989_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1989 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1990_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1990 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1991_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1991 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1992_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1992 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1993_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1993 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1994_0dbb0652-e487-4678-a747-b379f75821dc 36987-1994 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1995_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1995 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1996_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1996 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1997_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1997 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1998_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1998 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-1999_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1999 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2000_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2000 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2001_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2001 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2002_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2002 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2003_0dbb0652-e487-4678-a747-b379f75821dc 36987-2003 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2004_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2004 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2005_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2005 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2006_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2006 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2007_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2007 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2008_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2008 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2009_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2009 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2010_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2010 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2011_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2011 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2012_0dbb0652-e487-4678-a747-b379f75821dc 36987-2012 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2013_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2013 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2014_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2014 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2015_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2015 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2016_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2016 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2017_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2017 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2018_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2018 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2019_df67ce4b-b36a-4b3b-a1dc-0f6f00661092 36987-2019 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora sphaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2020_65e63469-f7b2-41e0-b3ab-af471b6b5542 36987-2020 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora sphaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2021_e1e95062-bc51-41aa-9192-7fcbf93be13a 36987-2021 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora sphaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2022_23e797dd-af20-4ed3-8c4d-eed59804742e 36987-2022 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora sphaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2023_27ad9add-410a-42cc-b48c-b1e3a043aacf 36987-2023 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora sphaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2024_763b329a-87a0-400e-ba56-92c31959599f 36987-2024 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora sphaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2025_977f6afc-d125-43a5-94fa-c278dbb2a166 36987-2025 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora sphaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2026_c8059bfd-f6a0-47c0-9c2f-7673975b4f6e 36987-2026 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora shaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2027_333d60d2-2a8c-4a82-922b-490696e55e89 36987-2027 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora sphaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2037_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2037 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2038_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2038 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2039_0dbb0652-e487-4678-a747-b379f75821dc 36987-2039 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2040_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2040 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2041_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2041 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2042_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2042 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2043_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2043 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2044_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2044 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2045_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2045 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2046_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2046 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2047_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2047 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2048_0dbb0652-e487-4678-a747-b379f75821dc 36987-2048 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2049_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2049 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2050_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2050 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2051_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2051 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2052_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2052 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2053_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2053 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2054_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2054 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2055_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2055 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA 10000 [PNU]/mL 36987-2056_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2056 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA 10000 [PNU]/mL 36987-2057_0dbb0652-e487-4678-a747-b379f75821dc 36987-2057 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA 20000 [PNU]/mL 36987-2058_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2058 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA 20000 [PNU]/mL 36987-2059_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2059 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA 40000 [PNU]/mL 36987-2060_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2060 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA .05 g/mL 36987-2061_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2061 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA .05 g/mL 36987-2062_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2062 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA .1 g/mL 36987-2063_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2063 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA .1 g/mL 36987-2064_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2064 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2065_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2065 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2066_0dbb0652-e487-4678-a747-b379f75821dc 36987-2066 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2067_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2067 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2068_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2068 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2069_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2069 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2070_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2070 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2071_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2071 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2072_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2072 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2073_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2073 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2074_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2074 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2075_0dbb0652-e487-4678-a747-b379f75821dc 36987-2075 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2076_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2076 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2077_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2077 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2078_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2078 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2079_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2079 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2080_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2080 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2081_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2081 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2082_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2082 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2083_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2083 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2084_0dbb0652-e487-4678-a747-b379f75821dc 36987-2084 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2085_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2085 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2086_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2086 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2087_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2087 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2088_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2088 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2089_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2089 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2090_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2090 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2091_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2091 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-2092_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2092 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-2093_0dbb0652-e487-4678-a747-b379f75821dc 36987-2093 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-2094_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2094 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-2095_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2095 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-2096_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2096 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-2097_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2097 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-2098_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2098 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-2099_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2099 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 36987-2109_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2109 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2110_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2110 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2111_0dbb0652-e487-4678-a747-b379f75821dc 36987-2111 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2112_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2112 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2113_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2113 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2114_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2114 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2115_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2115 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2116_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2116 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2117_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2117 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2118_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2118 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2119_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2119 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2120_0dbb0652-e487-4678-a747-b379f75821dc 36987-2120 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2121_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2121 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2122_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2122 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2123_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2123 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2124_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2124 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2125_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2125 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2126_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2126 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2127_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2127 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2128_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2128 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2129_0dbb0652-e487-4678-a747-b379f75821dc 36987-2129 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2130_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2130 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2131_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2131 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2132_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2132 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2133_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2133 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2134_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2134 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2135_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2135 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2145_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2145 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2146_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2146 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2147_0dbb0652-e487-4678-a747-b379f75821dc 36987-2147 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2148_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2148 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2149_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2149 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2150_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2150 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2151_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2151 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2152_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2152 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2153_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2153 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2154_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2154 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2155_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2155 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2156_0dbb0652-e487-4678-a747-b379f75821dc 36987-2156 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2157_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2157 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2158_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2158 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2159_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2159 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2160_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2160 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2161_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2161 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2162_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2162 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2163_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2163 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2164_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2164 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2165_0dbb0652-e487-4678-a747-b379f75821dc 36987-2165 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2166_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2166 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2167_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2167 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2168_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2168 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2169_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2169 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2170_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2170 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2171_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2171 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2172_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2172 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2173_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2173 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2174_0dbb0652-e487-4678-a747-b379f75821dc 36987-2174 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2175_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2175 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2176_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2176 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2177_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2177 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2178_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2178 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2179_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2179 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2180_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2180 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2181_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2181 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2182_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2182 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2183_0dbb0652-e487-4678-a747-b379f75821dc 36987-2183 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2184_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2184 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2185_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2185 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2186_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2186 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2187_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2187 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2188_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2188 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2189_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2189 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2194_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2194 HUMAN PRESCRIPTION DRUG Cotton Cotton INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON .05 g/mL 36987-2195_17b9e66f-a212-49c5-b9da-713086e386e3 36987-2195 HUMAN PRESCRIPTION DRUG Cotton Cotton INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON .05 g/mL 36987-2196_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2196 HUMAN PRESCRIPTION DRUG Cotton Cotton INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON .1 g/mL 36987-2197_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2197 HUMAN PRESCRIPTION DRUG Cotton Cotton INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON .1 g/mL 36987-2202_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2202 HUMAN PRESCRIPTION DRUG Cotton Linters Cotton Linters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2203_17b9e66f-a212-49c5-b9da-713086e386e3 36987-2203 HUMAN PRESCRIPTION DRUG Cotton Linters Cotton Linters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2204_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2204 HUMAN PRESCRIPTION DRUG Cotton Linters Cotton Linters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2205_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2205 HUMAN PRESCRIPTION DRUG Cotton Linters Cotton Linters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2210_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2210 HUMAN PRESCRIPTION DRUG Cotton Seed Cotton Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-2211_17b9e66f-a212-49c5-b9da-713086e386e3 36987-2211 HUMAN PRESCRIPTION DRUG Cotton Seed Cotton Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-2212_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2212 HUMAN PRESCRIPTION DRUG Cotton Seed Cotton Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-2213_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2213 HUMAN PRESCRIPTION DRUG Cotton Seed Cotton Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-2214_f70401b9-9617-41a7-a0c6-ded6f6efa9fa 36987-2214 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLAX SEED 10000 [PNU]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-2215_f8ad594a-24c1-4cb6-bf12-f4f6359c4494 36987-2215 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLAX SEED 10000 [PNU]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-2216_089ffe5f-49a3-4c82-a942-fa4207e7c34c 36987-2216 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLAX SEED 20000 [PNU]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-2217_de8ac52f-f946-4ae1-a219-362c06931040 36987-2217 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLAX SEED 20000 [PNU]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-2218_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2218 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLAX SEED .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-2219_17b9e66f-a212-49c5-b9da-713086e386e3 36987-2219 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLAX SEED .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-2220_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2220 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLAX SEED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-2221_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2221 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLAX SEED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 36987-2226_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2226 HUMAN PRESCRIPTION DRUG Kapok Kapok INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CEIBA PENTANDRA FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2227_17b9e66f-a212-49c5-b9da-713086e386e3 36987-2227 HUMAN PRESCRIPTION DRUG Kapok Kapok INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CEIBA PENTANDRA FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2228_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2228 HUMAN PRESCRIPTION DRUG Kapok Kapok INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CEIBA PENTANDRA FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2229_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2229 HUMAN PRESCRIPTION DRUG Kapok Kapok INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CEIBA PENTANDRA FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2234_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2234 HUMAN PRESCRIPTION DRUG Orris Root Orris Root INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IRIS GERMANICA VAR. FLORENTINA ROOT .05 g/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient] 36987-2235_17b9e66f-a212-49c5-b9da-713086e386e3 36987-2235 HUMAN PRESCRIPTION DRUG Orris Root Orris Root INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IRIS GERMANICA VAR. FLORENTINA ROOT .05 g/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient] 36987-2236_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2236 HUMAN PRESCRIPTION DRUG Orris Root Orris Root INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IRIS GERMANICA VAR. FLORENTINA ROOT .1 g/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient] 36987-2237_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2237 HUMAN PRESCRIPTION DRUG Orris Root Orris Root INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IRIS GERMANICA VAR. FLORENTINA ROOT .1 g/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient] 36987-2238_f70401b9-9617-41a7-a0c6-ded6f6efa9fa 36987-2238 HUMAN PRESCRIPTION DRUG Tobacco Leaf Tobacco Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOBACCO LEAF 10000 [PNU]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-2239_f8ad594a-24c1-4cb6-bf12-f4f6359c4494 36987-2239 HUMAN PRESCRIPTION DRUG Tobacco Leaf Tobacco Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOBACCO LEAF 10000 [PNU]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-2240_089ffe5f-49a3-4c82-a942-fa4207e7c34c 36987-2240 HUMAN PRESCRIPTION DRUG Tobacco Leaf Tobacco Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOBACCO LEAF 20000 [PNU]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-2242_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2242 HUMAN PRESCRIPTION DRUG Tobacco Leaf Tobacco Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOBACCO LEAF .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-2244_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2244 HUMAN PRESCRIPTION DRUG Tobacco Leaf Tobacco Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOBACCO LEAF .025 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-2245_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2245 HUMAN PRESCRIPTION DRUG Tobacco Leaf Tobacco Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOBACCO LEAF .025 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 36987-2246_f70401b9-9617-41a7-a0c6-ded6f6efa9fa 36987-2246 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORCORUS CAPSULARIS FIBER 10000 [PNU]/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2247_f8ad594a-24c1-4cb6-bf12-f4f6359c4494 36987-2247 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORCORUS CAPSULARIS FIBER 10000 [PNU]/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2248_089ffe5f-49a3-4c82-a942-fa4207e7c34c 36987-2248 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORCORUS CAPSULARIS FIBER 20000 [PNU]/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2249_de8ac52f-f946-4ae1-a219-362c06931040 36987-2249 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORCORUS CAPSULARIS FIBER 20000 [PNU]/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2250_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2250 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORCORUS CAPSULARIS FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2251_17b9e66f-a212-49c5-b9da-713086e386e3 36987-2251 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORCORUS CAPSULARIS FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2252_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2252 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORCORUS CAPSULARIS FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2253_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2253 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORCORUS CAPSULARIS FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2254_f70401b9-9617-41a7-a0c6-ded6f6efa9fa 36987-2254 HUMAN PRESCRIPTION DRUG Sisal Sisal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AGAVE SISALANA FIBER 10000 [PNU]/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2255_f8ad594a-24c1-4cb6-bf12-f4f6359c4494 36987-2255 HUMAN PRESCRIPTION DRUG Sisal Sisal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AGAVE SISALANA FIBER 10000 [PNU]/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2256_089ffe5f-49a3-4c82-a942-fa4207e7c34c 36987-2256 HUMAN PRESCRIPTION DRUG Sisal Sisal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AGAVE SISALANA FIBER 20000 [PNU]/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2257_de8ac52f-f946-4ae1-a219-362c06931040 36987-2257 HUMAN PRESCRIPTION DRUG Sisal Sisal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AGAVE SISALANA FIBER 20000 [PNU]/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2258_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2258 HUMAN PRESCRIPTION DRUG Sisal Sisal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AGAVE SISALANA FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2259_17b9e66f-a212-49c5-b9da-713086e386e3 36987-2259 HUMAN PRESCRIPTION DRUG Sisal Sisal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AGAVE SISALANA FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2260_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2260 HUMAN PRESCRIPTION DRUG Sisal Sisal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AGAVE SISALANA FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2261_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2261 HUMAN PRESCRIPTION DRUG Sisal Sisal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AGAVE SISALANA FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2262_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2262 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASPALUM NOTATUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2263_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2263 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASPALUM NOTATUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2264_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2264 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASPALUM NOTATUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2265_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2265 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASPALUM NOTATUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2266_46893e16-0a95-41cc-816f-c05a3a464967 36987-2266 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASPALUM NOTATUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2267_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2267 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASPALUM NOTATUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2268_686f64e3-7748-4964-9c12-68dfd082025a 36987-2268 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASPALUM NOTATUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2269_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2269 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASPALUM NOTATUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2270_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2270 HUMAN PRESCRIPTION DRUG Standardized Bermuda Grass Pollen Standardized Bermuda Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102195 Nelco Laboratories, Inc. CYNODON DACTYLON POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2271_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2271 HUMAN PRESCRIPTION DRUG Annual Blue Grass Annual Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA ANNUA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2272_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2272 HUMAN PRESCRIPTION DRUG Annual Blue Grass Annual Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA ANNUA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2273_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2273 HUMAN PRESCRIPTION DRUG Annual Blue Grass Annual Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA ANNUA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2274_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2274 HUMAN PRESCRIPTION DRUG Annual Blue Grass Annual Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA ANNUA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2275_46893e16-0a95-41cc-816f-c05a3a464967 36987-2275 HUMAN PRESCRIPTION DRUG Annual Blue Grass Annual Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA ANNUA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2276_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2276 HUMAN PRESCRIPTION DRUG Annual Blue Grass Annual Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2277_686f64e3-7748-4964-9c12-68dfd082025a 36987-2277 HUMAN PRESCRIPTION DRUG Annual Blue Grass Annual Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2278_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2278 HUMAN PRESCRIPTION DRUG Annual Blue Grass Annual Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA ANNUA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2279_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2279 HUMAN PRESCRIPTION DRUG Canadian Blue Grass Canadian Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA COMPRESSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2280_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2280 HUMAN PRESCRIPTION DRUG Canadian Blue Grass Canadian Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA COMPRESSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2281_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2281 HUMAN PRESCRIPTION DRUG Canadian Blue Grass Canadian Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA COMPRESSA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2282_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2282 HUMAN PRESCRIPTION DRUG Canadian Blue Grass Canadian Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA COMPRESSA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2283_46893e16-0a95-41cc-816f-c05a3a464967 36987-2283 HUMAN PRESCRIPTION DRUG Canadian Blue Grass Canadian Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA COMPRESSA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2284_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2284 HUMAN PRESCRIPTION DRUG Canadian Blue Grass Canadian Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA COMPRESSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2285_686f64e3-7748-4964-9c12-68dfd082025a 36987-2285 HUMAN PRESCRIPTION DRUG Canadian Blue Grass Canadian Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA COMPRESSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2286_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2286 HUMAN PRESCRIPTION DRUG Canadian Blue Grass Canadian Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA COMPRESSA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2287_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2287 HUMAN PRESCRIPTION DRUG Brome Grass Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2288_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2288 HUMAN PRESCRIPTION DRUG Brome Grass Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2289_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2289 HUMAN PRESCRIPTION DRUG Brome Grass Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2290_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2290 HUMAN PRESCRIPTION DRUG Brome Grass Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2291_46893e16-0a95-41cc-816f-c05a3a464967 36987-2291 HUMAN PRESCRIPTION DRUG Brome Grass Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2292_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2292 HUMAN PRESCRIPTION DRUG Brome Grass Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2293_686f64e3-7748-4964-9c12-68dfd082025a 36987-2293 HUMAN PRESCRIPTION DRUG Brome Grass Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2294_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2294 HUMAN PRESCRIPTION DRUG Brome Grass Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2295_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2295 HUMAN PRESCRIPTION DRUG Canary Grass Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2296_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2296 HUMAN PRESCRIPTION DRUG Canary Grass Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2297_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2297 HUMAN PRESCRIPTION DRUG Canary Grass Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2298_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2298 HUMAN PRESCRIPTION DRUG Canary Grass Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2299_46893e16-0a95-41cc-816f-c05a3a464967 36987-2299 HUMAN PRESCRIPTION DRUG Canary Grass Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2300_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2300 HUMAN PRESCRIPTION DRUG Canary Grass Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2301_686f64e3-7748-4964-9c12-68dfd082025a 36987-2301 HUMAN PRESCRIPTION DRUG Canary Grass Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2302_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2302 HUMAN PRESCRIPTION DRUG Canary Grass Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2303_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2303 HUMAN PRESCRIPTION DRUG Corn Grass Corn Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ZEA MAYS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2304_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2304 HUMAN PRESCRIPTION DRUG Corn Grass Corn Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ZEA MAYS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2305_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2305 HUMAN PRESCRIPTION DRUG Corn Grass Corn Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ZEA MAYS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2306_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2306 HUMAN PRESCRIPTION DRUG Corn Grass Corn Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ZEA MAYS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2307_46893e16-0a95-41cc-816f-c05a3a464967 36987-2307 HUMAN PRESCRIPTION DRUG Corn Grass Corn Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ZEA MAYS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2308_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2308 HUMAN PRESCRIPTION DRUG Corn Grass Corn Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ZEA MAYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2309_686f64e3-7748-4964-9c12-68dfd082025a 36987-2309 HUMAN PRESCRIPTION DRUG Corn Grass Corn Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ZEA MAYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2310_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2310 HUMAN PRESCRIPTION DRUG Corn Grass Corn Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ZEA MAYS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2311_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2311 HUMAN PRESCRIPTION DRUG Couch Quack Grass Couch Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2312_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2312 HUMAN PRESCRIPTION DRUG Couch Quack Grass Couch Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2313_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2313 HUMAN PRESCRIPTION DRUG Couch Quack Grass Couch Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2314_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2314 HUMAN PRESCRIPTION DRUG Couch Quack Grass Couch Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2315_46893e16-0a95-41cc-816f-c05a3a464967 36987-2315 HUMAN PRESCRIPTION DRUG Couch Quack Grass Couch Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2316_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2316 HUMAN PRESCRIPTION DRUG Couch Quack Grass Couch Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2317_686f64e3-7748-4964-9c12-68dfd082025a 36987-2317 HUMAN PRESCRIPTION DRUG Couch Quack Grass Couch Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2318_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2318 HUMAN PRESCRIPTION DRUG Couch Quack Grass Couch Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2319_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2319 HUMAN PRESCRIPTION DRUG Standardized Meadow Fescue Grass Pollen Standardized Meadow Fescue Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102197 Nelco Laboratories, Inc. FESTUCA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2320_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2320 HUMAN PRESCRIPTION DRUG Standardized Meadow Fescue Grass Pollen Standardized Meadow Fescue Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102197 Nelco Laboratories, Inc. FESTUCA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2321_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2321 HUMAN PRESCRIPTION DRUG Grama Grass Grama Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOUTELOUA GRACILIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2322_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2322 HUMAN PRESCRIPTION DRUG Grama Grass Grama Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOUTELOUA GRACILIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2323_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2323 HUMAN PRESCRIPTION DRUG Grama Grass Grama Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOUTELOUA GRACILIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2324_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2324 HUMAN PRESCRIPTION DRUG Grama Grass Grama Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOUTELOUA GRACILIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2325_46893e16-0a95-41cc-816f-c05a3a464967 36987-2325 HUMAN PRESCRIPTION DRUG Grama Grass Grama Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOUTELOUA GRACILIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2326_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2326 HUMAN PRESCRIPTION DRUG Grama Grass Grama Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOUTELOUA GRACILIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2327_686f64e3-7748-4964-9c12-68dfd082025a 36987-2327 HUMAN PRESCRIPTION DRUG Grama Grass Grama Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOUTELOUA GRACILIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2328_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2328 HUMAN PRESCRIPTION DRUG Grama Grass Grama Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOUTELOUA GRACILIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2329_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2329 HUMAN PRESCRIPTION DRUG Johnson Grass Johnson Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SORGHUM HALEPENSE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2330_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2330 HUMAN PRESCRIPTION DRUG Johnson Grass Johnson Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SORGHUM HALEPENSE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2331_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2331 HUMAN PRESCRIPTION DRUG Johnson Grass Johnson Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SORGHUM HALEPENSE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2332_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2332 HUMAN PRESCRIPTION DRUG Johnson Grass Johnson Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SORGHUM HALEPENSE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2333_46893e16-0a95-41cc-816f-c05a3a464967 36987-2333 HUMAN PRESCRIPTION DRUG Johnson Grass Johnson Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SORGHUM HALEPENSE POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2334_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2334 HUMAN PRESCRIPTION DRUG Johnson Grass Johnson Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SORGHUM HALEPENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2335_686f64e3-7748-4964-9c12-68dfd082025a 36987-2335 HUMAN PRESCRIPTION DRUG Johnson Grass Johnson Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SORGHUM HALEPENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2336_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2336 HUMAN PRESCRIPTION DRUG Johnson Grass Johnson Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SORGHUM HALEPENSE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2337_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2337 HUMAN PRESCRIPTION DRUG Cultivated Oat Cultivated Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVENA SATIVA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2338_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2338 HUMAN PRESCRIPTION DRUG Cultivated Oat Cultivated Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVENA SATIVA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2339_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2339 HUMAN PRESCRIPTION DRUG Cultivated Oat Cultivated Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVENA SATIVA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2340_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2340 HUMAN PRESCRIPTION DRUG Cultivated Oat Cultivated Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVENA SATIVA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2341_46893e16-0a95-41cc-816f-c05a3a464967 36987-2341 HUMAN PRESCRIPTION DRUG Cultivated Oat Cultivated Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVENA SATIVA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2342_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2342 HUMAN PRESCRIPTION DRUG Cultivated Oat Cultivated Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVENA SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2343_686f64e3-7748-4964-9c12-68dfd082025a 36987-2343 HUMAN PRESCRIPTION DRUG Cultivated Oat Cultivated Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVENA SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2344_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2344 HUMAN PRESCRIPTION DRUG Cultivated Oat Cultivated Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVENA SATIVA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2345_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2345 HUMAN PRESCRIPTION DRUG Standardized Orchard Grass Pollen Standardized Orchard Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102198 Nelco Laboratories, Inc. DACTYLIS GLOMERATA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2346_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2346 HUMAN PRESCRIPTION DRUG Standardized Orchard Grass Pollen Standardized Orchard Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102198 Nelco Laboratories, Inc. DACTYLIS GLOMERATA POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2347_8b77d740-1dae-42ac-95ec-156c998f7266 36987-2347 HUMAN PRESCRIPTION DRUG Para Grass Pollen Para Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. UROCHLOA MUTICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2348_e76475f4-84f5-47f0-9d91-50abb81fbfaa 36987-2348 HUMAN PRESCRIPTION DRUG Para Grass Pollen Para Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. UROCHLOA MUTICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2349_4e286c80-4d2a-433b-9ea5-2e7678db4c2f 36987-2349 HUMAN PRESCRIPTION DRUG Para Grass Pollen Para Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. UROCHLOA MUTICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2350_5afe0fb9-ffff-4dc2-8f99-2654574c5d57 36987-2350 HUMAN PRESCRIPTION DRUG Para Grass Pollen Para Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. UROCHLOA MUTICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2351_07ebc83d-6caa-4f78-a98b-997fc70d9a08 36987-2351 HUMAN PRESCRIPTION DRUG Para Grass Pollen Para Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. UROCHLOA MUTICA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2352_2e9b7a7b-447e-4e5e-b327-09ceb22e0901 36987-2352 HUMAN PRESCRIPTION DRUG Para Grass Pollen Para Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. UROCHLOA MUTICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2353_c4e39aa1-65b2-4426-a5ac-7e6ad761d7b8 36987-2353 HUMAN PRESCRIPTION DRUG Para Grass Pollen Para Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. UROCHLOA MUTICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2354_e0e5cad7-f73f-49ca-b0fe-e59630c501fa 36987-2354 HUMAN PRESCRIPTION DRUG Para Grass Pollen Para Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. UROCHLOA MUTICA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2355_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2355 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2356_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2356 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2357_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2357 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2358_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2358 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2359_46893e16-0a95-41cc-816f-c05a3a464967 36987-2359 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2360_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2360 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2361_686f64e3-7748-4964-9c12-68dfd082025a 36987-2361 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2362_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2362 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2363_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2363 HUMAN PRESCRIPTION DRUG Standardized Redtop Grass Pollen Standardized Redtop Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102192 Nelco Laboratories, Inc. AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2364_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2364 HUMAN PRESCRIPTION DRUG Standardized Redtop Grass Pollen Standardized Redtop Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102192 Nelco Laboratories, Inc. AGROSTIS GIGANTEA POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2365_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2365 HUMAN PRESCRIPTION DRUG Cultivated Rye Cultivated Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SECALE CEREALE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2366_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2366 HUMAN PRESCRIPTION DRUG Cultivated Rye Cultivated Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SECALE CEREALE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2367_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2367 HUMAN PRESCRIPTION DRUG Cultivated Rye Cultivated Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SECALE CEREALE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2368_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2368 HUMAN PRESCRIPTION DRUG Cultivated Rye Cultivated Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SECALE CEREALE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2369_46893e16-0a95-41cc-816f-c05a3a464967 36987-2369 HUMAN PRESCRIPTION DRUG Cultivated Rye Cultivated Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SECALE CEREALE POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2370_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2370 HUMAN PRESCRIPTION DRUG Cultivated Rye Cultivated Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SECALE CEREALE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2371_686f64e3-7748-4964-9c12-68dfd082025a 36987-2371 HUMAN PRESCRIPTION DRUG Cultivated Rye Cultivated Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SECALE CEREALE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2372_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2372 HUMAN PRESCRIPTION DRUG Cultivated Rye Cultivated Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SECALE CEREALE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2373_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2373 HUMAN PRESCRIPTION DRUG Giant Wild Rye Giant Wild Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEYMUS CONDENSATUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2374_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2374 HUMAN PRESCRIPTION DRUG Giant Wild Rye Giant Wild Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEYMUS CONDENSATUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2375_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2375 HUMAN PRESCRIPTION DRUG Giant Wild Rye Giant Wild Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEYMUS CONDENSATUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2376_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2376 HUMAN PRESCRIPTION DRUG Giant Wild Rye Giant Wild Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEYMUS CONDENSATUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2377_46893e16-0a95-41cc-816f-c05a3a464967 36987-2377 HUMAN PRESCRIPTION DRUG Giant Wild Rye Giant Wild Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEYMUS CONDENSATUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2378_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2378 HUMAN PRESCRIPTION DRUG Giant Wild Rye Giant Wild Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEYMUS CONDENSATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2379_686f64e3-7748-4964-9c12-68dfd082025a 36987-2379 HUMAN PRESCRIPTION DRUG Giant Wild Rye Giant Wild Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEYMUS CONDENSATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2380_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2380 HUMAN PRESCRIPTION DRUG Giant Wild Rye Giant Wild Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEYMUS CONDENSATUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2381_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2381 HUMAN PRESCRIPTION DRUG Italian Rye Grass Italian Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2382_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2382 HUMAN PRESCRIPTION DRUG Italian Rye Grass Italian Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2383_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2383 HUMAN PRESCRIPTION DRUG Italian Rye Grass Italian Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2384_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2384 HUMAN PRESCRIPTION DRUG Italian Rye Grass Italian Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2385_46893e16-0a95-41cc-816f-c05a3a464967 36987-2385 HUMAN PRESCRIPTION DRUG Italian Rye Grass Italian Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2386_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2386 HUMAN PRESCRIPTION DRUG Italian Rye Grass Italian Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2387_686f64e3-7748-4964-9c12-68dfd082025a 36987-2387 HUMAN PRESCRIPTION DRUG Italian Rye Grass Italian Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2388_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2388 HUMAN PRESCRIPTION DRUG Italian Rye Grass Italian Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2389_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2389 HUMAN PRESCRIPTION DRUG Standardized Perennial Rye Grass Pollen Standardized Perennial Rye Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102200 Nelco Laboratories, Inc. LOLIUM PERENNE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2390_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2390 HUMAN PRESCRIPTION DRUG Standardized Perennial Rye Grass Pollen Standardized Perennial Rye Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102200 Nelco Laboratories, Inc. LOLIUM PERENNE POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2391_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2391 HUMAN PRESCRIPTION DRUG Salt Grass Salt Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2392_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2392 HUMAN PRESCRIPTION DRUG Salt Grass Salt Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2393_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2393 HUMAN PRESCRIPTION DRUG Salt Grass Salt Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2394_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2394 HUMAN PRESCRIPTION DRUG Salt Grass Salt Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2395_46893e16-0a95-41cc-816f-c05a3a464967 36987-2395 HUMAN PRESCRIPTION DRUG Salt Grass Salt Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2396_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2396 HUMAN PRESCRIPTION DRUG Salt Grass Salt Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2397_686f64e3-7748-4964-9c12-68dfd082025a 36987-2397 HUMAN PRESCRIPTION DRUG Salt Grass Salt Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2398_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2398 HUMAN PRESCRIPTION DRUG Salt Grass Salt Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2399_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2399 HUMAN PRESCRIPTION DRUG Standardized Sweet Vernal Grass Pollen Standardized Sweet Vernal Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102201 Nelco Laboratories, Inc. ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2400_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2400 HUMAN PRESCRIPTION DRUG Standardized Sweet Vernal Grass Pollen Standardized Sweet Vernal Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102201 Nelco Laboratories, Inc. ANTHOXANTHUM ODORATUM POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2401_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2401 HUMAN PRESCRIPTION DRUG Standardized Timothy Grass Pollen Standardized Timothy Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102202 Nelco Laboratories, Inc. PHLEUM PRATENSE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2402_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2402 HUMAN PRESCRIPTION DRUG Standardized Timothy Grass Pollen Standardized Timothy Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102202 Nelco Laboratories, Inc. PHLEUM PRATENSE POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2403_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2403 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2404_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2404 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2405_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2405 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2406_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2406 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2407_46893e16-0a95-41cc-816f-c05a3a464967 36987-2407 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2408_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2408 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2409_686f64e3-7748-4964-9c12-68dfd082025a 36987-2409 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2410_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2410 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2411_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2411 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRITICUM AESTIVUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2412_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2412 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRITICUM AESTIVUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2413_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2413 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRITICUM AESTIVUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2414_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2414 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRITICUM AESTIVUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2415_46893e16-0a95-41cc-816f-c05a3a464967 36987-2415 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRITICUM AESTIVUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2416_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2416 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRITICUM AESTIVUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2417_686f64e3-7748-4964-9c12-68dfd082025a 36987-2417 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRITICUM AESTIVUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2418_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2418 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRITICUM AESTIVUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2419_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2419 HUMAN PRESCRIPTION DRUG West Wheat Grass West Wheat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASCOPYRUM SMITHII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2420_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2420 HUMAN PRESCRIPTION DRUG West Wheat Grass West Wheat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASCOPYRUM SMITHII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2421_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2421 HUMAN PRESCRIPTION DRUG West Wheat Grass West Wheat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASCOPYRUM SMITHII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2422_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2422 HUMAN PRESCRIPTION DRUG West Wheat Grass West Wheat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASCOPYRUM SMITHII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2423_46893e16-0a95-41cc-816f-c05a3a464967 36987-2423 HUMAN PRESCRIPTION DRUG West Wheat Grass West Wheat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASCOPYRUM SMITHII POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2424_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2424 HUMAN PRESCRIPTION DRUG West Wheat Grass West Wheat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASCOPYRUM SMITHII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2425_686f64e3-7748-4964-9c12-68dfd082025a 36987-2425 HUMAN PRESCRIPTION DRUG West Wheat Grass West Wheat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASCOPYRUM SMITHII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2426_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2426 HUMAN PRESCRIPTION DRUG West Wheat Grass West Wheat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASCOPYRUM SMITHII POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2427_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2427 HUMAN PRESCRIPTION DRUG Standardized Kentucky (June) Bluegrass Pollen Standardized Kentucky (June) Bluegrass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102196 Nelco Laboratories, Inc. POA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2428_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2428 HUMAN PRESCRIPTION DRUG Standardized Kentucky (June) Bluegrass Pollen Standardized Kentucky (June) Bluegrass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102196 Nelco Laboratories, Inc. POA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2429_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2429 HUMAN PRESCRIPTION DRUG Soft Cheat Brome Soft Cheat Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2430_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2430 HUMAN PRESCRIPTION DRUG Soft Cheat Brome Soft Cheat Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2431_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2431 HUMAN PRESCRIPTION DRUG Soft Cheat Brome Soft Cheat Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2432_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2432 HUMAN PRESCRIPTION DRUG Soft Cheat Brome Soft Cheat Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2433_46893e16-0a95-41cc-816f-c05a3a464967 36987-2433 HUMAN PRESCRIPTION DRUG Soft Cheat Brome Soft Cheat Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2434_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2434 HUMAN PRESCRIPTION DRUG Soft Cheat Brome Soft Cheat Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2435_686f64e3-7748-4964-9c12-68dfd082025a 36987-2435 HUMAN PRESCRIPTION DRUG Soft Cheat Brome Soft Cheat Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2436_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2436 HUMAN PRESCRIPTION DRUG Soft Cheat Brome Soft Cheat Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2437_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2437 HUMAN PRESCRIPTION DRUG Smooth Brome Smooth Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2438_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2438 HUMAN PRESCRIPTION DRUG Smooth Brome Smooth Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2439_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2439 HUMAN PRESCRIPTION DRUG Smooth Brome Smooth Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2440_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2440 HUMAN PRESCRIPTION DRUG Smooth Brome Smooth Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2441_46893e16-0a95-41cc-816f-c05a3a464967 36987-2441 HUMAN PRESCRIPTION DRUG Smooth Brome Smooth Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2442_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2442 HUMAN PRESCRIPTION DRUG Smooth Brome Smooth Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2443_686f64e3-7748-4964-9c12-68dfd082025a 36987-2443 HUMAN PRESCRIPTION DRUG Smooth Brome Smooth Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2444_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2444 HUMAN PRESCRIPTION DRUG Smooth Brome Smooth Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2445_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2445 HUMAN PRESCRIPTION DRUG Acacia Acacia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA BAILEYANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2446_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2446 HUMAN PRESCRIPTION DRUG Acacia Acacia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA BAILEYANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2447_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2447 HUMAN PRESCRIPTION DRUG Acacia Acacia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA BAILEYANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2448_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2448 HUMAN PRESCRIPTION DRUG Acacia Acacia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA BAILEYANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2449_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2449 HUMAN PRESCRIPTION DRUG Acacia Acacia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA BAILEYANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2450_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2450 HUMAN PRESCRIPTION DRUG Acacia Acacia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA BAILEYANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2451_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2451 HUMAN PRESCRIPTION DRUG Acacia Acacia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA BAILEYANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2452_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2452 HUMAN PRESCRIPTION DRUG Acacia Acacia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA BAILEYANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2453_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2453 HUMAN PRESCRIPTION DRUG Red Alder Red Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RUBRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2454_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2454 HUMAN PRESCRIPTION DRUG Red Alder Red Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RUBRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2455_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2455 HUMAN PRESCRIPTION DRUG Red Alder Red Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RUBRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2456_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2456 HUMAN PRESCRIPTION DRUG Red Alder Red Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RUBRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2457_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2457 HUMAN PRESCRIPTION DRUG Red Alder Red Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RUBRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2458_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2458 HUMAN PRESCRIPTION DRUG Red Alder Red Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2459_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2459 HUMAN PRESCRIPTION DRUG Red Alder Red Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2460_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2460 HUMAN PRESCRIPTION DRUG Red Alder Red Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RUBRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2461_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2461 HUMAN PRESCRIPTION DRUG Tag Alder Tag Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2462_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2462 HUMAN PRESCRIPTION DRUG Tag Alder Tag Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2463_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2463 HUMAN PRESCRIPTION DRUG Tag Alder Tag Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2464_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2464 HUMAN PRESCRIPTION DRUG Tag Alder Tag Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2465_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2465 HUMAN PRESCRIPTION DRUG Tag Alder Tag Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2466_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2466 HUMAN PRESCRIPTION DRUG Tag Alder Tag Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2467_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2467 HUMAN PRESCRIPTION DRUG Tag Alder Tag Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2468_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2468 HUMAN PRESCRIPTION DRUG Tag Alder Tag Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2469_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2469 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2470_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2470 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2471_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2471 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2472_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2472 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2473_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2473 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2474_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2474 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2475_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2475 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2476_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2476 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2477_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2477 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS VELUTINA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2478_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2478 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS VELUTINA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2479_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2479 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS VELUTINA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2480_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2480 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS VELUTINA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2481_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2481 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS VELUTINA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2482_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2482 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS VELUTINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2483_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2483 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS VELUTINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2484_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2484 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS VELUTINA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2485_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2485 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2486_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2486 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2487_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2487 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2488_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2488 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2489_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2489 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2490_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2490 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2491_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2491 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2492_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2492 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2493_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2493 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2494_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2494 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2495_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2495 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2496_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2496 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2497_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2497 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS AMERICANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2498_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2498 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2499_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2499 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2500_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2500 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2501_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2501 HUMAN PRESCRIPTION DRUG Aspen Aspen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS TREMULOIDES POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2502_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2502 HUMAN PRESCRIPTION DRUG Aspen Aspen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS TREMULOIDES POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2503_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2503 HUMAN PRESCRIPTION DRUG Aspen Aspen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS TREMULOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2504_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2504 HUMAN PRESCRIPTION DRUG Aspen Aspen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS TREMULOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2505_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2505 HUMAN PRESCRIPTION DRUG Aspen Aspen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS TREMULOIDES POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2506_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2506 HUMAN PRESCRIPTION DRUG Aspen Aspen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS TREMULOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2507_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2507 HUMAN PRESCRIPTION DRUG Aspen Aspen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS TREMULOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2508_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2508 HUMAN PRESCRIPTION DRUG Aspen Aspen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS TREMULOIDES POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2509_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2509 HUMAN PRESCRIPTION DRUG Bayberry Bayberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORELLA CERIFERA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2510_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2510 HUMAN PRESCRIPTION DRUG Bayberry Bayberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORELLA CERIFERA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2511_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2511 HUMAN PRESCRIPTION DRUG Bayberry Bayberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORELLA CERIFERA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2512_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2512 HUMAN PRESCRIPTION DRUG Bayberry Bayberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORELLA CERIFERA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2513_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2513 HUMAN PRESCRIPTION DRUG Bayberry Bayberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORELLA CERIFERA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2514_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2514 HUMAN PRESCRIPTION DRUG Bayberry Bayberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORELLA CERIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2515_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2515 HUMAN PRESCRIPTION DRUG Bayberry Bayberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORELLA CERIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2516_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2516 HUMAN PRESCRIPTION DRUG Bayberry Bayberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORELLA CERIFERA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2517_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2517 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2518_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2518 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2519_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2519 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2520_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2520 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2521_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2521 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2522_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2522 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2523_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2523 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2524_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2524 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2525_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2525 HUMAN PRESCRIPTION DRUG Beefwood/Australian Pine Beefwood/Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2526_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2526 HUMAN PRESCRIPTION DRUG Beefwood/Australian Pine Beefwood/Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2527_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2527 HUMAN PRESCRIPTION DRUG Beefwood/Australian Pine Beefwood/Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2528_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2528 HUMAN PRESCRIPTION DRUG Beefwood/Australian Pine Beefwood/Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2529_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2529 HUMAN PRESCRIPTION DRUG Beefwood/Australian Pine Beefwood/Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2530_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2530 HUMAN PRESCRIPTION DRUG Beefwood/Australian Pine Beefwood/Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2531_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2531 HUMAN PRESCRIPTION DRUG Beefwood/Australian Pine Beefwood/Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2532_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2532 HUMAN PRESCRIPTION DRUG Beefwood/Australian Pine Beefwood/Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2533_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2533 HUMAN PRESCRIPTION DRUG Birch Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2534_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2534 HUMAN PRESCRIPTION DRUG Birch Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2535_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2535 HUMAN PRESCRIPTION DRUG Birch Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2536_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2536 HUMAN PRESCRIPTION DRUG Birch Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2537_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2537 HUMAN PRESCRIPTION DRUG Birch Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA NIGRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2538_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2538 HUMAN PRESCRIPTION DRUG Birch Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2539_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2539 HUMAN PRESCRIPTION DRUG Birch Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2540_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2540 HUMAN PRESCRIPTION DRUG Birch Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2541_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2541 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA LENTA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2542_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2542 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA LENTA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2543_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2543 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA LENTA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2544_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2544 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA LENTA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2545_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2545 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA LENTA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2546_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2546 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA LENTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2547_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2547 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA LENTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2548_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2548 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA LENTA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2549_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2549 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA POPULIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2550_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2550 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA POPULIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2551_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2551 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA POPULIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2552_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2552 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA POPULIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2553_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2553 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA POPULIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2554_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2554 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA POPULIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2555_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2555 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA POPULIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2556_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2556 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA POPULIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2557_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2557 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER NEGUNDO POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2558_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2558 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER NEGUNDO POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2559_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2559 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER NEGUNDO POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2560_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2560 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER NEGUNDO POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2561_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2561 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER NEGUNDO POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2562_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2562 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER NEGUNDO POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2563_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2563 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER NEGUNDO POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2564_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2564 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER NEGUNDO POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2565_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2565 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS ASHEI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2566_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2566 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS ASHEI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2567_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2567 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS ASHEI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2568_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2568 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS ASHEI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2569_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2569 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS ASHEI POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2570_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2570 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2571_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2571 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2572_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2572 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS ASHEI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2573_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2573 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2574_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2574 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2575_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2575 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2576_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2576 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2577_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2577 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2578_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2578 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2579_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2579 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2580_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2580 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2581_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2581 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAMARIX GALLICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2582_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2582 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAMARIX GALLICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2583_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2583 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAMARIX GALLICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2584_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2584 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAMARIX GALLICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2585_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2585 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAMARIX GALLICA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2586_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2586 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAMARIX GALLICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2587_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2587 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAMARIX GALLICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2588_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2588 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAMARIX GALLICA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2589_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2589 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2590_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2590 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2591_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2591 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2592_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2592 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2593_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2593 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2594_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2594 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2595_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2595 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2596_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2596 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2597_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2597 HUMAN PRESCRIPTION DRUG Fremont Cottonwood Fremont Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS FREMONTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2598_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2598 HUMAN PRESCRIPTION DRUG Fremont Cottonwood Fremont Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS FREMONTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2599_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2599 HUMAN PRESCRIPTION DRUG Fremont Cottonwood Fremont Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS FREMONTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2600_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2600 HUMAN PRESCRIPTION DRUG Fremont Cottonwood Fremont Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS FREMONTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2601_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2601 HUMAN PRESCRIPTION DRUG Fremont Cottonwood Fremont Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS FREMONTII POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2602_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2602 HUMAN PRESCRIPTION DRUG Fremont Cottonwood Fremont Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS FREMONTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2603_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2603 HUMAN PRESCRIPTION DRUG Fremont Cottonwood Fremont Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS FREMONTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2604_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2604 HUMAN PRESCRIPTION DRUG Fremont Cottonwood Fremont Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS FREMONTII POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2605_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2605 HUMAN PRESCRIPTION DRUG West Cottonwood West Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2606_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2606 HUMAN PRESCRIPTION DRUG West Cottonwood West Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2607_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2607 HUMAN PRESCRIPTION DRUG West Cottonwood West Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2608_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2608 HUMAN PRESCRIPTION DRUG West Cottonwood West Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2609_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2609 HUMAN PRESCRIPTION DRUG West Cottonwood West Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2610_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2610 HUMAN PRESCRIPTION DRUG West Cottonwood West Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2611_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2611 HUMAN PRESCRIPTION DRUG West Cottonwood West Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2612_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2612 HUMAN PRESCRIPTION DRUG West Cottonwood West Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2613_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2613 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2614_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2614 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2615_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2615 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2616_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2616 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2617_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2617 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2618_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2618 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2619_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2619 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2620_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2620 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2621_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2621 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAXODIUM DISTICHUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2622_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2622 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAXODIUM DISTICHUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2623_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2623 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAXODIUM DISTICHUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2624_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2624 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAXODIUM DISTICHUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2625_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2625 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAXODIUM DISTICHUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2626_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2626 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAXODIUM DISTICHUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2627_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2627 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAXODIUM DISTICHUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2628_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2628 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAXODIUM DISTICHUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2629_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2629 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2630_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2630 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2631_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2631 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2632_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2632 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2633_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2633 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS AMERICANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2634_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2634 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2635_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2635 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2636_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2636 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2637_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2637 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2638_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2638 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2639_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2639 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2640_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2640 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2641_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2641 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2642_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2642 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2643_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2643 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2644_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2644 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2645_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2645 HUMAN PRESCRIPTION DRUG Chinese Elm Chinese Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS PUMILA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2646_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2646 HUMAN PRESCRIPTION DRUG Chinese Elm Chinese Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS PUMILA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2647_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2647 HUMAN PRESCRIPTION DRUG Chinese Elm Chinese Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS PUMILA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2648_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2648 HUMAN PRESCRIPTION DRUG Chinese Elm Chinese Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS PUMILA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2649_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2649 HUMAN PRESCRIPTION DRUG Chinese Elm Chinese Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS PUMILA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2650_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2650 HUMAN PRESCRIPTION DRUG Chinese Elm Chinese Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS PUMILA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2651_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2651 HUMAN PRESCRIPTION DRUG Chinese Elm Chinese Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS PUMILA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2652_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2652 HUMAN PRESCRIPTION DRUG Chinese Elm Chinese Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS PUMILA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2653_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2653 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2654_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2654 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2655_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2655 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2656_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2656 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2657_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2657 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2658_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2658 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2659_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2659 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2660_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2660 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2661_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2661 HUMAN PRESCRIPTION DRUG Hazelnut Hazelnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORYLUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2662_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2662 HUMAN PRESCRIPTION DRUG Hazelnut Hazelnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORYLUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2663_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2663 HUMAN PRESCRIPTION DRUG Hazelnut Hazelnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORYLUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2664_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2664 HUMAN PRESCRIPTION DRUG Hazelnut Hazelnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORYLUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2665_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2665 HUMAN PRESCRIPTION DRUG Hazelnut Hazelnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORYLUS AMERICANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2666_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2666 HUMAN PRESCRIPTION DRUG Hazelnut Hazelnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORYLUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2667_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2667 HUMAN PRESCRIPTION DRUG Hazelnut Hazelnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORYLUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2668_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2668 HUMAN PRESCRIPTION DRUG Hazelnut Hazelnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORYLUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2669_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2669 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA OVATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2670_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2670 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA OVATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2671_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2671 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA OVATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2672_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2672 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA OVATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2673_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2673 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA OVATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2674_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2674 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA OVATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2675_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2675 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA OVATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2676_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2676 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA OVATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2677_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2677 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2678_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2678 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2679_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2679 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2680_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2680 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2681_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2681 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ALBA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2682_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2682 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2683_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2683 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2684_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2684 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2685_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2685 HUMAN PRESCRIPTION DRUG One Seed Juniper One Seed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2686_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2686 HUMAN PRESCRIPTION DRUG One Seed Juniper One Seed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2687_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2687 HUMAN PRESCRIPTION DRUG One Seed Juniper One Seed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2688_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2688 HUMAN PRESCRIPTION DRUG One Seed Juniper One Seed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2689_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2689 HUMAN PRESCRIPTION DRUG One Seed Juniper One Seed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2690_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2690 HUMAN PRESCRIPTION DRUG One Seed Juniper One Seed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2691_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2691 HUMAN PRESCRIPTION DRUG One Seed Juniper One Seed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2692_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2692 HUMAN PRESCRIPTION DRUG One Seed Juniper One Seed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2693_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2693 HUMAN PRESCRIPTION DRUG Pinchot Juniper Pinchot Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2694_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2694 HUMAN PRESCRIPTION DRUG Pinchot Juniper Pinchot Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2695_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2695 HUMAN PRESCRIPTION DRUG Pinchot Juniper Pinchot Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2696_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2696 HUMAN PRESCRIPTION DRUG Pinchot Juniper Pinchot Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2697_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2697 HUMAN PRESCRIPTION DRUG Pinchot Juniper Pinchot Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2698_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2698 HUMAN PRESCRIPTION DRUG Pinchot Juniper Pinchot Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2699_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2699 HUMAN PRESCRIPTION DRUG Pinchot Juniper Pinchot Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2700_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2700 HUMAN PRESCRIPTION DRUG Pinchot Juniper Pinchot Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2701_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2701 HUMAN PRESCRIPTION DRUG Rocky Mountain Juniper Rocky Mountain Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2702_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2702 HUMAN PRESCRIPTION DRUG Rocky Mountain Juniper Rocky Mountain Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2703_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2703 HUMAN PRESCRIPTION DRUG Rocky Mountain Juniper Rocky Mountain Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2704_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2704 HUMAN PRESCRIPTION DRUG Rocky Mountain Juniper Rocky Mountain Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2705_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2705 HUMAN PRESCRIPTION DRUG Rocky Mountain Juniper Rocky Mountain Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2706_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2706 HUMAN PRESCRIPTION DRUG Rocky Mountain Juniper Rocky Mountain Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2707_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2707 HUMAN PRESCRIPTION DRUG Rocky Mountain Juniper Rocky Mountain Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2708_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2708 HUMAN PRESCRIPTION DRUG Rocky Mountain Juniper Rocky Mountain Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2709_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2709 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2710_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2710 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2711_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2711 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2712_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2712 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2713_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2713 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2714_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2714 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2715_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2715 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2716_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2716 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2717_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2717 HUMAN PRESCRIPTION DRUG Western Juniper Western Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2718_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2718 HUMAN PRESCRIPTION DRUG Western Juniper Western Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2719_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2719 HUMAN PRESCRIPTION DRUG Western Juniper Western Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2720_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2720 HUMAN PRESCRIPTION DRUG Western Juniper Western Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2721_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2721 HUMAN PRESCRIPTION DRUG Western Juniper Western Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2722_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2722 HUMAN PRESCRIPTION DRUG Western Juniper Western Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2723_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2723 HUMAN PRESCRIPTION DRUG Western Juniper Western Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2724_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2724 HUMAN PRESCRIPTION DRUG Western Juniper Western Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2725_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2725 HUMAN PRESCRIPTION DRUG Linden Linden INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILIA AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2726_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2726 HUMAN PRESCRIPTION DRUG Linden Linden INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILIA AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2727_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2727 HUMAN PRESCRIPTION DRUG Linden Linden INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILIA AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2728_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2728 HUMAN PRESCRIPTION DRUG Linden Linden INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILIA AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2729_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2729 HUMAN PRESCRIPTION DRUG Linden Linden INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILIA AMERICANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2730_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2730 HUMAN PRESCRIPTION DRUG Linden Linden INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILIA AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2731_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2731 HUMAN PRESCRIPTION DRUG Linden Linden INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILIA AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2732_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2732 HUMAN PRESCRIPTION DRUG Linden Linden INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILIA AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2733_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2733 HUMAN PRESCRIPTION DRUG Black Locust Black Locust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2734_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2734 HUMAN PRESCRIPTION DRUG Black Locust Black Locust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2735_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2735 HUMAN PRESCRIPTION DRUG Black Locust Black Locust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2736_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2736 HUMAN PRESCRIPTION DRUG Black Locust Black Locust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2737_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2737 HUMAN PRESCRIPTION DRUG Black Locust Black Locust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2738_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2738 HUMAN PRESCRIPTION DRUG Black Locust Black Locust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2739_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2739 HUMAN PRESCRIPTION DRUG Black Locust Black Locust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2740_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2740 HUMAN PRESCRIPTION DRUG Black Locust Black Locust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2741_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2741 HUMAN PRESCRIPTION DRUG Mango Blossom Mango Blossom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGIFERA INDICA POLLEN 10000 [PNU]/mL 36987-2742_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2742 HUMAN PRESCRIPTION DRUG Mango Blossom Mango Blossom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGIFERA INDICA POLLEN 10000 [PNU]/mL 36987-2743_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2743 HUMAN PRESCRIPTION DRUG Mango Blossom Mango Blossom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGIFERA INDICA POLLEN 20000 [PNU]/mL 36987-2744_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2744 HUMAN PRESCRIPTION DRUG Mango Blossom Mango Blossom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGIFERA INDICA POLLEN 20000 [PNU]/mL 36987-2745_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2745 HUMAN PRESCRIPTION DRUG Mango Blossom Mango Blossom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGIFERA INDICA POLLEN 40000 [PNU]/mL 36987-2746_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2746 HUMAN PRESCRIPTION DRUG Mango Blossom Mango Blossom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGIFERA INDICA POLLEN .05 g/mL 36987-2747_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2747 HUMAN PRESCRIPTION DRUG Mango Blossom Mango Blossom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGIFERA INDICA POLLEN .05 g/mL 36987-2748_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2748 HUMAN PRESCRIPTION DRUG Mango Blossom Mango Blossom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGIFERA INDICA POLLEN .1 g/mL 36987-2749_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2749 HUMAN PRESCRIPTION DRUG Coast Maple Coast Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER MACROPHYLLUM POLLEN 10000 [PNU]/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-2750_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2750 HUMAN PRESCRIPTION DRUG Coast Maple Coast Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER MACROPHYLLUM POLLEN 10000 [PNU]/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-2751_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2751 HUMAN PRESCRIPTION DRUG Coast Maple Coast Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER MACROPHYLLUM POLLEN 20000 [PNU]/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-2752_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2752 HUMAN PRESCRIPTION DRUG Coast Maple Coast Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER MACROPHYLLUM POLLEN 20000 [PNU]/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-2753_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2753 HUMAN PRESCRIPTION DRUG Coast Maple Coast Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER MACROPHYLLUM POLLEN 40000 [PNU]/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-2754_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2754 HUMAN PRESCRIPTION DRUG Coast Maple Coast Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER MACROPHYLLUM POLLEN .05 g/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-2755_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2755 HUMAN PRESCRIPTION DRUG Coast Maple Coast Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER MACROPHYLLUM POLLEN .05 g/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-2756_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2756 HUMAN PRESCRIPTION DRUG Coast Maple Coast Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER MACROPHYLLUM POLLEN .1 g/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 36987-2757_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2757 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER RUBRUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2758_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2758 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER RUBRUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2759_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2759 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER RUBRUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2760_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2760 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER RUBRUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2761_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2761 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER RUBRUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2762_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2762 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER RUBRUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2763_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2763 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER RUBRUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2764_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2764 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER RUBRUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2765_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2765 HUMAN PRESCRIPTION DRUG Silver Maple Silver Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARINUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2766_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2766 HUMAN PRESCRIPTION DRUG Silver Maple Silver Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARINUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2767_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2767 HUMAN PRESCRIPTION DRUG Silver Maple Silver Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARINUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2768_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2768 HUMAN PRESCRIPTION DRUG Silver Maple Silver Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARINUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2769_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2769 HUMAN PRESCRIPTION DRUG Silver Maple Silver Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARINUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2770_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2770 HUMAN PRESCRIPTION DRUG Silver Maple Silver Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARINUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2771_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2771 HUMAN PRESCRIPTION DRUG Silver Maple Silver Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARINUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2772_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2772 HUMAN PRESCRIPTION DRUG Silver Maple Silver Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARINUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2773_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2773 HUMAN PRESCRIPTION DRUG Sugar Maple Sugar Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2774_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2774 HUMAN PRESCRIPTION DRUG Sugar Maple Sugar Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2775_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2775 HUMAN PRESCRIPTION DRUG Sugar Maple Sugar Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2776_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2776 HUMAN PRESCRIPTION DRUG Sugar Maple Sugar Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2777_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2777 HUMAN PRESCRIPTION DRUG Sugar Maple Sugar Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2778_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2778 HUMAN PRESCRIPTION DRUG Sugar Maple Sugar Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2779_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2779 HUMAN PRESCRIPTION DRUG Sugar Maple Sugar Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2780_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2780 HUMAN PRESCRIPTION DRUG Sugar Maple Sugar Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2781_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2781 HUMAN PRESCRIPTION DRUG Melaleuca Pollen Melaleuca Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2782_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2782 HUMAN PRESCRIPTION DRUG Melaleuca Pollen Melaleuca Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2783_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2783 HUMAN PRESCRIPTION DRUG Melaleuca Pollen Melaleuca Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2784_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2784 HUMAN PRESCRIPTION DRUG Melaleuca Pollen Melaleuca Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2785_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2785 HUMAN PRESCRIPTION DRUG Melaleuca Pollen Melaleuca Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2786_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2786 HUMAN PRESCRIPTION DRUG Melaleuca Pollen Melaleuca Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2787_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2787 HUMAN PRESCRIPTION DRUG Melaleuca Pollen Melaleuca Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2788_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2788 HUMAN PRESCRIPTION DRUG Melaleuca Pollen Melaleuca Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2789_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2789 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PROSOPIS JULIFLORA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2790_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2790 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PROSOPIS JULIFLORA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2791_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2791 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PROSOPIS JULIFLORA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2792_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2792 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PROSOPIS JULIFLORA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2793_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2793 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PROSOPIS JULIFLORA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2794_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2794 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PROSOPIS JULIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2795_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2795 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PROSOPIS JULIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2796_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2796 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PROSOPIS JULIFLORA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2797_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2797 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2798_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2798 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2799_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2799 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2800_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2800 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2801_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2801 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS ALBA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2802_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2802 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2803_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2803 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2804_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2804 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2805_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2805 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS RUBRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2806_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2806 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS RUBRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2807_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2807 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS RUBRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2808_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2808 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS RUBRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2809_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2809 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS RUBRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2810_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2810 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2811_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2811 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2812_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2812 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS RUBRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2813_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2813 HUMAN PRESCRIPTION DRUG Mulberry Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2814_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2814 HUMAN PRESCRIPTION DRUG Mulberry Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2815_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2815 HUMAN PRESCRIPTION DRUG Mulberry Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2816_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2816 HUMAN PRESCRIPTION DRUG Mulberry Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2817_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2817 HUMAN PRESCRIPTION DRUG Mulberry Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2818_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2818 HUMAN PRESCRIPTION DRUG Mulberry Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2819_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2819 HUMAN PRESCRIPTION DRUG Mulberry Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2820_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2820 HUMAN PRESCRIPTION DRUG Mulberry Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2821_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2821 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VELUTINA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2822_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2822 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VELUTINA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2823_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2823 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VELUTINA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2824_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2824 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VELUTINA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2825_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2825 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VELUTINA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2826_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2826 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VELUTINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2827_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2827 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VELUTINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2828_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2828 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VELUTINA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2829_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2829 HUMAN PRESCRIPTION DRUG Burr Oak Burr Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS MACROCARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2830_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2830 HUMAN PRESCRIPTION DRUG Burr Oak Burr Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS MACROCARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2831_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2831 HUMAN PRESCRIPTION DRUG Burr Oak Burr Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS MACROCARPA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2832_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2832 HUMAN PRESCRIPTION DRUG Burr Oak Burr Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS MACROCARPA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2833_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2833 HUMAN PRESCRIPTION DRUG Burr Oak Burr Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS MACROCARPA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2834_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2834 HUMAN PRESCRIPTION DRUG Burr Oak Burr Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS MACROCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2835_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2835 HUMAN PRESCRIPTION DRUG Burr Oak Burr Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS MACROCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2836_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2836 HUMAN PRESCRIPTION DRUG Burr Oak Burr Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS MACROCARPA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2837_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2837 HUMAN PRESCRIPTION DRUG California Black Oak California Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS KELLOGGII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2838_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2838 HUMAN PRESCRIPTION DRUG California Black Oak California Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS KELLOGGII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2839_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2839 HUMAN PRESCRIPTION DRUG California Black Oak California Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS KELLOGGII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2840_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2840 HUMAN PRESCRIPTION DRUG California Black Oak California Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS KELLOGGII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2841_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2841 HUMAN PRESCRIPTION DRUG California Black Oak California Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS KELLOGGII POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2842_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2842 HUMAN PRESCRIPTION DRUG California Black Oak California Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS KELLOGGII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2843_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2843 HUMAN PRESCRIPTION DRUG California Black Oak California Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS KELLOGGII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2844_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2844 HUMAN PRESCRIPTION DRUG California Black Oak California Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS KELLOGGII POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2845_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2845 HUMAN PRESCRIPTION DRUG California Live Oak California Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2846_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2846 HUMAN PRESCRIPTION DRUG California Live Oak California Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2847_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2847 HUMAN PRESCRIPTION DRUG California Live Oak California Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2848_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2848 HUMAN PRESCRIPTION DRUG California Live Oak California Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2849_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2849 HUMAN PRESCRIPTION DRUG California Live Oak California Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2850_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2850 HUMAN PRESCRIPTION DRUG California Live Oak California Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2851_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2851 HUMAN PRESCRIPTION DRUG California Live Oak California Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2852_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2852 HUMAN PRESCRIPTION DRUG California Live Oak California Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2853_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2853 HUMAN PRESCRIPTION DRUG Gambil Oak Gambil Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS GAMBELII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2854_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2854 HUMAN PRESCRIPTION DRUG Gambil Oak Gambil Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS GAMBELII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2855_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2855 HUMAN PRESCRIPTION DRUG Gambil Oak Gambil Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS GAMBELII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2856_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2856 HUMAN PRESCRIPTION DRUG Gambil Oak Gambil Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS GAMBELII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2857_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2857 HUMAN PRESCRIPTION DRUG Gambil Oak Gambil Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS GAMBELII POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2858_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2858 HUMAN PRESCRIPTION DRUG Gambil Oak Gambil Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS GAMBELII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2859_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2859 HUMAN PRESCRIPTION DRUG Gambil Oak Gambil Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS GAMBELII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2860_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2860 HUMAN PRESCRIPTION DRUG Gambil Oak Gambil Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS GAMBELII POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2861_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2861 HUMAN PRESCRIPTION DRUG Red Oak Red Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS RUBRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2862_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2862 HUMAN PRESCRIPTION DRUG Red Oak Red Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS RUBRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2863_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2863 HUMAN PRESCRIPTION DRUG Red Oak Red Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS RUBRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2864_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2864 HUMAN PRESCRIPTION DRUG Red Oak Red Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS RUBRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2865_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2865 HUMAN PRESCRIPTION DRUG Red Oak Red Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS RUBRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2866_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2866 HUMAN PRESCRIPTION DRUG Red Oak Red Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2867_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2867 HUMAN PRESCRIPTION DRUG Red Oak Red Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2868_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2868 HUMAN PRESCRIPTION DRUG Red Oak Red Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS RUBRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2869_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2869 HUMAN PRESCRIPTION DRUG California Valley White Oak California Valley White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS LOBATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2870_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2870 HUMAN PRESCRIPTION DRUG California Valley White Oak California Valley White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS LOBATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2871_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2871 HUMAN PRESCRIPTION DRUG California Valley White Oak California Valley White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS LOBATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2872_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2872 HUMAN PRESCRIPTION DRUG California Valley White Oak California Valley White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS LOBATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2873_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2873 HUMAN PRESCRIPTION DRUG California Valley White Oak California Valley White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS LOBATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2874_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2874 HUMAN PRESCRIPTION DRUG California Valley White Oak California Valley White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS LOBATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2875_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2875 HUMAN PRESCRIPTION DRUG California Valley White Oak California Valley White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS LOBATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2876_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2876 HUMAN PRESCRIPTION DRUG California Valley White Oak California Valley White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS LOBATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2877_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2877 HUMAN PRESCRIPTION DRUG Virginia Live Oak Virginia Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VIRGINIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2878_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2878 HUMAN PRESCRIPTION DRUG Virginia Live Oak Virginia Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VIRGINIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2879_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2879 HUMAN PRESCRIPTION DRUG Virginia Live Oak Virginia Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VIRGINIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2880_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2880 HUMAN PRESCRIPTION DRUG Virginia Live Oak Virginia Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VIRGINIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2881_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2881 HUMAN PRESCRIPTION DRUG Virginia Live Oak Virginia Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VIRGINIANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2882_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2882 HUMAN PRESCRIPTION DRUG Virginia Live Oak Virginia Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2883_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2883 HUMAN PRESCRIPTION DRUG Virginia Live Oak Virginia Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2884_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2884 HUMAN PRESCRIPTION DRUG Virginia Live Oak Virginia Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VIRGINIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2885_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2885 HUMAN PRESCRIPTION DRUG Water Oak Water Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2886_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2886 HUMAN PRESCRIPTION DRUG Water Oak Water Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2887_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2887 HUMAN PRESCRIPTION DRUG Water Oak Water Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2888_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2888 HUMAN PRESCRIPTION DRUG Water Oak Water Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2889_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2889 HUMAN PRESCRIPTION DRUG Water Oak Water Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS NIGRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2890_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2890 HUMAN PRESCRIPTION DRUG Water Oak Water Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2891_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2891 HUMAN PRESCRIPTION DRUG Water Oak Water Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2892_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2892 HUMAN PRESCRIPTION DRUG Water Oak Water Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2893_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2893 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2894_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2894 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2895_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2895 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2896_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2896 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2897_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2897 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS ALBA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2898_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2898 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2899_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2899 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2900_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2900 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2901_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2901 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OLEA EUROPAEA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2902_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2902 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OLEA EUROPAEA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2903_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2903 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OLEA EUROPAEA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2904_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2904 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OLEA EUROPAEA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2905_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2905 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OLEA EUROPAEA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2906_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2906 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OLEA EUROPAEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2907_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2907 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OLEA EUROPAEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2908_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2908 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OLEA EUROPAEA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2909_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2909 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CITRUS SINENSIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2910_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2910 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CITRUS SINENSIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2911_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2911 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CITRUS SINENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2912_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2912 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CITRUS SINENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2913_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2913 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CITRUS SINENSIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2914_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2914 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CITRUS SINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2915_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2915 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CITRUS SINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2916_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2916 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CITRUS SINENSIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2917_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2917 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2918_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2918 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2919_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2919 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2920_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2920 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2921_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2921 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2922_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2922 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2923_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2923 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2924_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2924 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2925_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2925 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ILLINOINENSIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2926_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2926 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ILLINOINENSIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2927_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2927 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ILLINOINENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2928_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2928 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ILLINOINENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2929_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2929 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ILLINOINENSIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2930_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2930 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ILLINOINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2931_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2931 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ILLINOINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2932_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2932 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ILLINOINENSIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2933_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2933 HUMAN PRESCRIPTION DRUG Pepper Tree Pollen Pepper Tree Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091204 BLA BLA102192 Nelco Laboratories, Inc. SCHINUS MOLLE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2934_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2934 HUMAN PRESCRIPTION DRUG Pepper Tree Pollen Pepper Tree Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091204 BLA BLA102192 Nelco Laboratories, Inc. SCHINUS MOLLE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2935_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2935 HUMAN PRESCRIPTION DRUG Pepper Tree Pollen Pepper Tree Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091204 BLA BLA102192 Nelco Laboratories, Inc. SCHINUS MOLLE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2936_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2936 HUMAN PRESCRIPTION DRUG Pepper Tree Pollen Pepper Tree Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091204 BLA BLA102192 Nelco Laboratories, Inc. SCHINUS MOLLE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2937_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2937 HUMAN PRESCRIPTION DRUG Pepper Tree Pollen Pepper Tree Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091204 BLA BLA102192 Nelco Laboratories, Inc. SCHINUS MOLLE POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2938_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2938 HUMAN PRESCRIPTION DRUG Pepper Tree Pollen Pepper Tree Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091204 BLA BLA102192 Nelco Laboratories, Inc. SCHINUS MOLLE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2939_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2939 HUMAN PRESCRIPTION DRUG Pepper Tree Pollen Pepper Tree Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091204 BLA BLA102192 Nelco Laboratories, Inc. SCHINUS MOLLE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2940_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2940 HUMAN PRESCRIPTION DRUG Pepper Tree Pollen Pepper Tree Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091204 BLA BLA102192 Nelco Laboratories, Inc. SCHINUS MOLLE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2941_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2941 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS TAEDA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2942_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2942 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS TAEDA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2943_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2943 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS TAEDA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2944_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2944 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS TAEDA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2945_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2945 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS TAEDA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2946_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2946 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS TAEDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2947_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2947 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS TAEDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2948_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2948 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS TAEDA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2949_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2949 HUMAN PRESCRIPTION DRUG Longleaf Pine Longleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PALUSTRIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2950_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2950 HUMAN PRESCRIPTION DRUG Longleaf Pine Longleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PALUSTRIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2951_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2951 HUMAN PRESCRIPTION DRUG Longleaf Pine Longleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PALUSTRIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2952_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2952 HUMAN PRESCRIPTION DRUG Longleaf Pine Longleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PALUSTRIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2953_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2953 HUMAN PRESCRIPTION DRUG Longleaf Pine Longleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PALUSTRIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2954_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2954 HUMAN PRESCRIPTION DRUG Longleaf Pine Longleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PALUSTRIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2955_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2955 HUMAN PRESCRIPTION DRUG Longleaf Pine Longleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PALUSTRIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2956_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2956 HUMAN PRESCRIPTION DRUG Longleaf Pine Longleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PALUSTRIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2957_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2957 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PONDEROSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2958_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2958 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PONDEROSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2959_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2959 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PONDEROSA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2960_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2960 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PONDEROSA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2961_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2961 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PONDEROSA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2962_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2962 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PONDEROSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2963_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2963 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PONDEROSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2964_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2964 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PONDEROSA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2965_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2965 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ELLIOTTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2966_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2966 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ELLIOTTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2967_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2967 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ELLIOTTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2968_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2968 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ELLIOTTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2969_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2969 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ELLIOTTII POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2970_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2970 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ELLIOTTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2971_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2971 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ELLIOTTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2972_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2972 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ELLIOTTII POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2973_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2973 HUMAN PRESCRIPTION DRUG Scrub Pine Scrub Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS VIRGINIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2974_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2974 HUMAN PRESCRIPTION DRUG Scrub Pine Scrub Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS VIRGINIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2975_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2975 HUMAN PRESCRIPTION DRUG Scrub Pine Scrub Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS VIRGINIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2976_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2976 HUMAN PRESCRIPTION DRUG Scrub Pine Scrub Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS VIRGINIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2977_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2977 HUMAN PRESCRIPTION DRUG Scrub Pine Scrub Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS VIRGINIANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2978_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2978 HUMAN PRESCRIPTION DRUG Scrub Pine Scrub Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2979_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2979 HUMAN PRESCRIPTION DRUG Scrub Pine Scrub Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2980_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2980 HUMAN PRESCRIPTION DRUG Scrub Pine Scrub Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS VIRGINIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2981_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2981 HUMAN PRESCRIPTION DRUG White Pine White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS STROBUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2982_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2982 HUMAN PRESCRIPTION DRUG White Pine White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS STROBUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2983_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2983 HUMAN PRESCRIPTION DRUG White Pine White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS STROBUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2984_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2984 HUMAN PRESCRIPTION DRUG White Pine White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS STROBUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2985_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2985 HUMAN PRESCRIPTION DRUG White Pine White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS STROBUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2986_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2986 HUMAN PRESCRIPTION DRUG White Pine White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS STROBUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2987_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2987 HUMAN PRESCRIPTION DRUG White Pine White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS STROBUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2988_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2988 HUMAN PRESCRIPTION DRUG White Pine White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS STROBUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2989_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2989 HUMAN PRESCRIPTION DRUG Western White Pine Western White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS MONTICOLA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2990_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2990 HUMAN PRESCRIPTION DRUG Western White Pine Western White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS MONTICOLA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2991_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2991 HUMAN PRESCRIPTION DRUG Western White Pine Western White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS MONTICOLA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2992_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2992 HUMAN PRESCRIPTION DRUG Western White Pine Western White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS MONTICOLA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2993_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2993 HUMAN PRESCRIPTION DRUG Western White Pine Western White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS MONTICOLA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2994_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2994 HUMAN PRESCRIPTION DRUG Western White Pine Western White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS MONTICOLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2995_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2995 HUMAN PRESCRIPTION DRUG Western White Pine Western White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS MONTICOLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2996_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2996 HUMAN PRESCRIPTION DRUG Western White Pine Western White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS MONTICOLA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2997_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2997 HUMAN PRESCRIPTION DRUG Yellow Pine Yellow Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ECHINATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2998_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2998 HUMAN PRESCRIPTION DRUG Yellow Pine Yellow Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ECHINATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-2999_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2999 HUMAN PRESCRIPTION DRUG Yellow Pine Yellow Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ECHINATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3000_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3000 HUMAN PRESCRIPTION DRUG Yellow Pine Yellow Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ECHINATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3001_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3001 HUMAN PRESCRIPTION DRUG Yellow Pine Yellow Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ECHINATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3002_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3002 HUMAN PRESCRIPTION DRUG Yellow Pine Yellow Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ECHINATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3003_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3003 HUMAN PRESCRIPTION DRUG Yellow Pine Yellow Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ECHINATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3004_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3004 HUMAN PRESCRIPTION DRUG Yellow Pine Yellow Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ECHINATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3005_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3005 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3006_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3006 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3007_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3007 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3008_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3008 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3009_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3009 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS NIGRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3010_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3010 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3011_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3011 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3012_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3012 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3013_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3013 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3014_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3014 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3015_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3015 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3016_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3016 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3017_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3017 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS ALBA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3018_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3018 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3019_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3019 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3020_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3020 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3021_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3021 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIGUSTRUM VULGARE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3022_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3022 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIGUSTRUM VULGARE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3023_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3023 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIGUSTRUM VULGARE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3024_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3024 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIGUSTRUM VULGARE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3025_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3025 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIGUSTRUM VULGARE POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3026_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3026 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIGUSTRUM VULGARE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3027_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3027 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIGUSTRUM VULGARE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3028_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3028 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIGUSTRUM VULGARE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3029_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3029 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3030_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3030 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3031_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3031 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3032_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3032 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3033_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3033 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3034_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3034 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3035_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3035 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3036_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3036 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3037_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3037 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3038_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3038 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3039_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3039 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3040_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3040 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3041_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3041 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3042_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3042 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3043_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3043 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3044_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3044 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3045_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3045 HUMAN PRESCRIPTION DRUG East Sycamore East Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3046_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3046 HUMAN PRESCRIPTION DRUG East Sycamore East Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3047_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3047 HUMAN PRESCRIPTION DRUG East Sycamore East Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3048_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3048 HUMAN PRESCRIPTION DRUG East Sycamore East Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3049_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3049 HUMAN PRESCRIPTION DRUG East Sycamore East Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3050_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3050 HUMAN PRESCRIPTION DRUG East Sycamore East Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3051_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3051 HUMAN PRESCRIPTION DRUG East Sycamore East Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3052_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3052 HUMAN PRESCRIPTION DRUG East Sycamore East Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3053_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3053 HUMAN PRESCRIPTION DRUG West Sycamore West Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS RACEMOSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3054_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3054 HUMAN PRESCRIPTION DRUG West Sycamore West Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS RACEMOSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3055_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3055 HUMAN PRESCRIPTION DRUG West Sycamore West Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS RACEMOSA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3056_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3056 HUMAN PRESCRIPTION DRUG West Sycamore West Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS RACEMOSA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3057_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3057 HUMAN PRESCRIPTION DRUG West Sycamore West Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS RACEMOSA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3058_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3058 HUMAN PRESCRIPTION DRUG West Sycamore West Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS RACEMOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3059_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3059 HUMAN PRESCRIPTION DRUG West Sycamore West Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS RACEMOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3060_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3060 HUMAN PRESCRIPTION DRUG West Sycamore West Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS RACEMOSA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3061_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3061 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3062_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3062 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3063_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3063 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3064_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3064 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3065_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3065 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS NIGRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3066_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3066 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3067_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3067 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3068_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3068 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3069_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3069 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS CALIFORNICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3070_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3070 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS CALIFORNICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3071_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3071 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS CALIFORNICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3072_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3072 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS CALIFORNICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3073_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3073 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS CALIFORNICA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3074_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3074 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3075_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3075 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3076_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3076 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS CALIFORNICA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3077_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3077 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS REGIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3078_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3078 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS REGIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3079_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3079 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS REGIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3080_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3080 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS REGIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3081_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3081 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS REGIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3082_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3082 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS REGIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3083_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3083 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS REGIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3084_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3084 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS REGIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3085_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3085 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX NIGRA POLLEN 10000 [PNU]/mL 36987-3086_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3086 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX NIGRA POLLEN 10000 [PNU]/mL 36987-3087_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3087 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX NIGRA POLLEN 20000 [PNU]/mL 36987-3088_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3088 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX NIGRA POLLEN 20000 [PNU]/mL 36987-3089_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3089 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX NIGRA POLLEN 40000 [PNU]/mL 36987-3090_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3090 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX NIGRA POLLEN .05 g/mL 36987-3091_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3091 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX NIGRA POLLEN .05 g/mL 36987-3092_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3092 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX NIGRA POLLEN .1 g/mL 36987-3093_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3093 HUMAN PRESCRIPTION DRUG Arroyo Willow Arroyo Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX LASIOLEPIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3094_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3094 HUMAN PRESCRIPTION DRUG Arroyo Willow Arroyo Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX LASIOLEPIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3095_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3095 HUMAN PRESCRIPTION DRUG Arroyo Willow Arroyo Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX LASIOLEPIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3096_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3096 HUMAN PRESCRIPTION DRUG Arroyo Willow Arroyo Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX LASIOLEPIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3097_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3097 HUMAN PRESCRIPTION DRUG Arroyo Willow Arroyo Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX LASIOLEPIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3098_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3098 HUMAN PRESCRIPTION DRUG Arroyo Willow Arroyo Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX LASIOLEPIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3099_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3099 HUMAN PRESCRIPTION DRUG Arroyo Willow Arroyo Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX LASIOLEPIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3100_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3100 HUMAN PRESCRIPTION DRUG Arroyo Willow Arroyo Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX LASIOLEPIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3101_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3101 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX DISCOLOR POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3102_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3102 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX DISCOLOR POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3103_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3103 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX DISCOLOR POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3104_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3104 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX DISCOLOR POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3105_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3105 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX DISCOLOR POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3106_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3106 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX DISCOLOR POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3107_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3107 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX DISCOLOR POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3108_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3108 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX DISCOLOR POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3109_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3109 HUMAN PRESCRIPTION DRUG Poplar Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3110_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3110 HUMAN PRESCRIPTION DRUG Poplar Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3111_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3111 HUMAN PRESCRIPTION DRUG Poplar Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3112_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3112 HUMAN PRESCRIPTION DRUG Poplar Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3113_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3113 HUMAN PRESCRIPTION DRUG Poplar Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3114_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3114 HUMAN PRESCRIPTION DRUG Poplar Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3115_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3115 HUMAN PRESCRIPTION DRUG Poplar Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3116_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3116 HUMAN PRESCRIPTION DRUG Poplar Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3117_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3117 HUMAN PRESCRIPTION DRUG Balsam Poplar Balsam Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3118_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3118 HUMAN PRESCRIPTION DRUG Balsam Poplar Balsam Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3119_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3119 HUMAN PRESCRIPTION DRUG Balsam Poplar Balsam Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3120_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3120 HUMAN PRESCRIPTION DRUG Balsam Poplar Balsam Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3121_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3121 HUMAN PRESCRIPTION DRUG Balsam Poplar Balsam Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3122_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3122 HUMAN PRESCRIPTION DRUG Balsam Poplar Balsam Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3123_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3123 HUMAN PRESCRIPTION DRUG Balsam Poplar Balsam Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3124_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3124 HUMAN PRESCRIPTION DRUG Balsam Poplar Balsam Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3125_45a21265-75ff-4634-a154-faff541e45d6 36987-3125 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TARAXACUM OFFICINALE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3126_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3126 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TARAXACUM OFFICINALE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3127_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3127 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TARAXACUM OFFICINALE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3128_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3128 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TARAXACUM OFFICINALE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3129_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3129 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TARAXACUM OFFICINALE POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3130_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3130 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TARAXACUM OFFICINALE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3131_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3131 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TARAXACUM OFFICINALE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3132_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3132 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TARAXACUM OFFICINALE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3133_45a21265-75ff-4634-a154-faff541e45d6 36987-3133 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3134_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3134 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3135_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3135 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3136_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3136 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3137_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3137 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3138_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3138 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3139_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3139 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3140_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3140 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3141_45a21265-75ff-4634-a154-faff541e45d6 36987-3141 HUMAN PRESCRIPTION DRUG Groundsel Groundsel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3142_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3142 HUMAN PRESCRIPTION DRUG Groundsel Groundsel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3143_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3143 HUMAN PRESCRIPTION DRUG Groundsel Groundsel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3144_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3144 HUMAN PRESCRIPTION DRUG Groundsel Groundsel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3145_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3145 HUMAN PRESCRIPTION DRUG Groundsel Groundsel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3146_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3146 HUMAN PRESCRIPTION DRUG Groundsel Groundsel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3147_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3147 HUMAN PRESCRIPTION DRUG Groundsel Groundsel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3148_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3148 HUMAN PRESCRIPTION DRUG Groundsel Groundsel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3149_45a21265-75ff-4634-a154-faff541e45d6 36987-3149 HUMAN PRESCRIPTION DRUG Burrobrush Burrobrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3150_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3150 HUMAN PRESCRIPTION DRUG Burrobrush Burrobrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3151_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3151 HUMAN PRESCRIPTION DRUG Burrobrush Burrobrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3152_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3152 HUMAN PRESCRIPTION DRUG Burrobrush Burrobrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3153_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3153 HUMAN PRESCRIPTION DRUG Burrobrush Burrobrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3154_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3154 HUMAN PRESCRIPTION DRUG Burrobrush Burrobrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3155_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3155 HUMAN PRESCRIPTION DRUG Burrobrush Burrobrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3156_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3156 HUMAN PRESCRIPTION DRUG Burrobrush Burrobrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3157_45a21265-75ff-4634-a154-faff541e45d6 36987-3157 HUMAN PRESCRIPTION DRUG Carelessweed Carelessweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3158_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3158 HUMAN PRESCRIPTION DRUG Carelessweed Carelessweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3159_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3159 HUMAN PRESCRIPTION DRUG Carelessweed Carelessweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3160_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3160 HUMAN PRESCRIPTION DRUG Carelessweed Carelessweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3161_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3161 HUMAN PRESCRIPTION DRUG Carelessweed Carelessweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3162_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3162 HUMAN PRESCRIPTION DRUG Carelessweed Carelessweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3163_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3163 HUMAN PRESCRIPTION DRUG Carelessweed Carelessweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3164_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3164 HUMAN PRESCRIPTION DRUG Carelessweed Carelessweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3165_45a21265-75ff-4634-a154-faff541e45d6 36987-3165 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3166_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3166 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3167_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3167 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3168_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3168 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3169_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3169 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3170_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3170 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3171_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3171 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3172_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3172 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3173_45a21265-75ff-4634-a154-faff541e45d6 36987-3173 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 10000 [PNU]/mL 36987-3174_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3174 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 10000 [PNU]/mL 36987-3175_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3175 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 20000 [PNU]/mL 36987-3176_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3176 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 20000 [PNU]/mL 36987-3177_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3177 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 40000 [PNU]/mL 36987-3178_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3178 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN .05 g/mL 36987-3179_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3179 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN .05 g/mL 36987-3180_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3180 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN .1 g/mL 36987-3181_45a21265-75ff-4634-a154-faff541e45d6 36987-3181 HUMAN PRESCRIPTION DRUG Curly Dock Curly Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3182_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3182 HUMAN PRESCRIPTION DRUG Curly Dock Curly Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3183_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3183 HUMAN PRESCRIPTION DRUG Curly Dock Curly Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3184_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3184 HUMAN PRESCRIPTION DRUG Curly Dock Curly Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3185_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3185 HUMAN PRESCRIPTION DRUG Curly Dock Curly Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3186_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3186 HUMAN PRESCRIPTION DRUG Curly Dock Curly Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3187_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3187 HUMAN PRESCRIPTION DRUG Curly Dock Curly Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3188_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3188 HUMAN PRESCRIPTION DRUG Curly Dock Curly Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3189_45a21265-75ff-4634-a154-faff541e45d6 36987-3189 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3190_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3190 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3191_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3191 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3192_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3192 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3193_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3193 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3194_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3194 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3195_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3195 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3196_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3196 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3197_45a21265-75ff-4634-a154-faff541e45d6 36987-3197 HUMAN PRESCRIPTION DRUG Firebush/Burning Bush Firebush/Burning Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KOCHIA SCOPARIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3198_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3198 HUMAN PRESCRIPTION DRUG Firebush/Burning Bush Firebush/Burning Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KOCHIA SCOPARIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3199_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3199 HUMAN PRESCRIPTION DRUG Firebush/Burning Bush Firebush/Burning Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KOCHIA SCOPARIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3200_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3200 HUMAN PRESCRIPTION DRUG Firebush/Burning Bush Firebush/Burning Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KOCHIA SCOPARIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3201_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3201 HUMAN PRESCRIPTION DRUG Firebush/Burning Bush Firebush/Burning Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KOCHIA SCOPARIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3202_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3202 HUMAN PRESCRIPTION DRUG Firebush/Burning Bush Firebush/Burning Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KOCHIA SCOPARIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3203_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3203 HUMAN PRESCRIPTION DRUG Firebush/Burning Bush Firebush/Burning Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KOCHIA SCOPARIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3204_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3204 HUMAN PRESCRIPTION DRUG Firebush/Burning Bush Firebush/Burning Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KOCHIA SCOPARIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3205_45a21265-75ff-4634-a154-faff541e45d6 36987-3205 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3206_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3206 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3207_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3207 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3208_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3208 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3209_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3209 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3210_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3210 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3211_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3211 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3212_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3212 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3213_45a21265-75ff-4634-a154-faff541e45d6 36987-3213 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3214_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3214 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3215_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3215 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3216_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3216 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3217_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3217 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3218_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3218 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3219_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3219 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3220_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3220 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3221_45a21265-75ff-4634-a154-faff541e45d6 36987-3221 HUMAN PRESCRIPTION DRUG Iodine Bush Iodine Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3222_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3222 HUMAN PRESCRIPTION DRUG Iodine Bush Iodine Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3223_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3223 HUMAN PRESCRIPTION DRUG Iodine Bush Iodine Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3224_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3224 HUMAN PRESCRIPTION DRUG Iodine Bush Iodine Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3225_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3225 HUMAN PRESCRIPTION DRUG Iodine Bush Iodine Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3226_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3226 HUMAN PRESCRIPTION DRUG Iodine Bush Iodine Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3227_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3227 HUMAN PRESCRIPTION DRUG Iodine Bush Iodine Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3228_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3228 HUMAN PRESCRIPTION DRUG Iodine Bush Iodine Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3229_45a21265-75ff-4634-a154-faff541e45d6 36987-3229 HUMAN PRESCRIPTION DRUG Lamb Quarters Lamb Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM ALBUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3230_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3230 HUMAN PRESCRIPTION DRUG Lamb Quarters Lamb Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM ALBUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3231_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3231 HUMAN PRESCRIPTION DRUG Lamb Quarters Lamb Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM ALBUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3232_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3232 HUMAN PRESCRIPTION DRUG Lamb Quarters Lamb Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM ALBUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3233_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3233 HUMAN PRESCRIPTION DRUG Lamb Quarters Lamb Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM ALBUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3234_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3234 HUMAN PRESCRIPTION DRUG Lamb Quarters Lamb Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3235_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3235 HUMAN PRESCRIPTION DRUG Lamb Quarters Lamb Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3236_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3236 HUMAN PRESCRIPTION DRUG Lamb Quarters Lamb Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM ALBUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3237_45a21265-75ff-4634-a154-faff541e45d6 36987-3237 HUMAN PRESCRIPTION DRUG Lenscale Quailbrush Lenscale Quailbrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3238_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3238 HUMAN PRESCRIPTION DRUG Lenscale Quailbrush Lenscale Quailbrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3239_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3239 HUMAN PRESCRIPTION DRUG Lenscale Quailbrush Lenscale Quailbrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3240_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3240 HUMAN PRESCRIPTION DRUG Lenscale Quailbrush Lenscale Quailbrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3241_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3241 HUMAN PRESCRIPTION DRUG Lenscale Quailbrush Lenscale Quailbrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3242_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3242 HUMAN PRESCRIPTION DRUG Lenscale Quailbrush Lenscale Quailbrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3243_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3243 HUMAN PRESCRIPTION DRUG Lenscale Quailbrush Lenscale Quailbrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3244_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3244 HUMAN PRESCRIPTION DRUG Lenscale Quailbrush Lenscale Quailbrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3245_45a21265-75ff-4634-a154-faff541e45d6 36987-3245 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA XANTHIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3246_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3246 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA XANTHIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3247_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3247 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA XANTHIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3248_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3248 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA XANTHIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3249_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3249 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA XANTHIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3250_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3250 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA XANTHIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3251_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3251 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA XANTHIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3252_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3252 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA XANTHIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3253_45a21265-75ff-4634-a154-faff541e45d6 36987-3253 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3254_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3254 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3255_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3255 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3256_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3256 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3257_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3257 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3258_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3258 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3259_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3259 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3260_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3260 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3261_45a21265-75ff-4634-a154-faff541e45d6 36987-3261 HUMAN PRESCRIPTION DRUG Mexican Tea Pollen Mexican Tea Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3262_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3262 HUMAN PRESCRIPTION DRUG Mexican Tea Pollen Mexican Tea Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3263_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3263 HUMAN PRESCRIPTION DRUG Mexican Tea Pollen Mexican Tea Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3264_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3264 HUMAN PRESCRIPTION DRUG Mexican Tea Pollen Mexican Tea Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3265_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3265 HUMAN PRESCRIPTION DRUG Mexican Tea Pollen Mexican Tea Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3266_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3266 HUMAN PRESCRIPTION DRUG Mexican Tea Pollen Mexican Tea Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3267_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3267 HUMAN PRESCRIPTION DRUG Mexican Tea Pollen Mexican Tea Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3268_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3268 HUMAN PRESCRIPTION DRUG Mexican Tea Pollen Mexican Tea Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3269_45a21265-75ff-4634-a154-faff541e45d6 36987-3269 HUMAN PRESCRIPTION DRUG Mugwort Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA VULGARIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3270_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3270 HUMAN PRESCRIPTION DRUG Mugwort Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA VULGARIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3271_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3271 HUMAN PRESCRIPTION DRUG Mugwort Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA VULGARIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3272_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3272 HUMAN PRESCRIPTION DRUG Mugwort Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA VULGARIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3273_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3273 HUMAN PRESCRIPTION DRUG Mugwort Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA VULGARIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3274_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3274 HUMAN PRESCRIPTION DRUG Mugwort Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3275_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3275 HUMAN PRESCRIPTION DRUG Mugwort Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3276_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3276 HUMAN PRESCRIPTION DRUG Mugwort Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA VULGARIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3277_903c0001-3108-4d4a-af2c-1404cd7a36d7 36987-3277 HUMAN PRESCRIPTION DRUG California Mugwort California Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA DOUGLASIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3278_afd9ee5b-b6ea-4bde-af79-31cf9b90dabb 36987-3278 HUMAN PRESCRIPTION DRUG California Mugwort California Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA DOUGLASIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3279_b4cdf699-2588-4332-b27a-e5e744132079 36987-3279 HUMAN PRESCRIPTION DRUG California Mugwort California Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA DOUGLASIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3280_2ae15a58-71ac-4434-bb4b-cc2fb15e22c0 36987-3280 HUMAN PRESCRIPTION DRUG California Mugwort California Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA DOUGLASIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3281_93372a13-7c59-413e-8cd6-95e187e54aad 36987-3281 HUMAN PRESCRIPTION DRUG California Mugwort California Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA DOUGLASIANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3282_435dd039-08c8-4e76-902b-d9ca9d4296ce 36987-3282 HUMAN PRESCRIPTION DRUG California Mugwort California Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA DOUGLASIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3283_f1334005-3717-4445-b780-d545be0be698 36987-3283 HUMAN PRESCRIPTION DRUG California Mugwort California Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA DOUGLASIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3284_35bbd7c6-95ec-4bc6-8dfc-e902926b7fb6 36987-3284 HUMAN PRESCRIPTION DRUG California Mugwort California Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA DOUGLASIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3285_45a21265-75ff-4634-a154-faff541e45d6 36987-3285 HUMAN PRESCRIPTION DRUG Darkleaves Mugwort Darkleaves Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3286_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3286 HUMAN PRESCRIPTION DRUG Darkleaves Mugwort Darkleaves Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3287_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3287 HUMAN PRESCRIPTION DRUG Darkleaves Mugwort Darkleaves Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3288_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3288 HUMAN PRESCRIPTION DRUG Darkleaves Mugwort Darkleaves Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3289_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3289 HUMAN PRESCRIPTION DRUG Darkleaves Mugwort Darkleaves Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3290_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3290 HUMAN PRESCRIPTION DRUG Darkleaves Mugwort Darkleaves Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3291_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3291 HUMAN PRESCRIPTION DRUG Darkleaves Mugwort Darkleaves Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3292_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3292 HUMAN PRESCRIPTION DRUG Darkleaves Mugwort Darkleaves Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3293_45a21265-75ff-4634-a154-faff541e45d6 36987-3293 HUMAN PRESCRIPTION DRUG Nettle Nettle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. URTICA DIOICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3294_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3294 HUMAN PRESCRIPTION DRUG Nettle Nettle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. URTICA DIOICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3295_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3295 HUMAN PRESCRIPTION DRUG Nettle Nettle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. URTICA DIOICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3296_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3296 HUMAN PRESCRIPTION DRUG Nettle Nettle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. URTICA DIOICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3297_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3297 HUMAN PRESCRIPTION DRUG Nettle Nettle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. URTICA DIOICA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3298_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3298 HUMAN PRESCRIPTION DRUG Nettle Nettle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. URTICA DIOICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3299_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3299 HUMAN PRESCRIPTION DRUG Nettle Nettle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. URTICA DIOICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3300_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3300 HUMAN PRESCRIPTION DRUG Nettle Nettle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. URTICA DIOICA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3301_45a21265-75ff-4634-a154-faff541e45d6 36987-3301 HUMAN PRESCRIPTION DRUG Palmers Amaranth Palmers Amaranth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3302_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3302 HUMAN PRESCRIPTION DRUG Palmers Amaranth Palmers Amaranth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3303_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3303 HUMAN PRESCRIPTION DRUG Palmers Amaranth Palmers Amaranth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3304_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3304 HUMAN PRESCRIPTION DRUG Palmers Amaranth Palmers Amaranth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3305_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3305 HUMAN PRESCRIPTION DRUG Palmers Amaranth Palmers Amaranth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3306_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3306 HUMAN PRESCRIPTION DRUG Palmers Amaranth Palmers Amaranth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3307_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3307 HUMAN PRESCRIPTION DRUG Palmers Amaranth Palmers Amaranth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3308_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3308 HUMAN PRESCRIPTION DRUG Palmers Amaranth Palmers Amaranth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3309_45a21265-75ff-4634-a154-faff541e45d6 36987-3309 HUMAN PRESCRIPTION DRUG Rough Pigweed Rough Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3310_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3310 HUMAN PRESCRIPTION DRUG Rough Pigweed Rough Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3311_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3311 HUMAN PRESCRIPTION DRUG Rough Pigweed Rough Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3312_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3312 HUMAN PRESCRIPTION DRUG Rough Pigweed Rough Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3313_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3313 HUMAN PRESCRIPTION DRUG Rough Pigweed Rough Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3314_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3314 HUMAN PRESCRIPTION DRUG Rough Pigweed Rough Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3315_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3315 HUMAN PRESCRIPTION DRUG Rough Pigweed Rough Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3316_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3316 HUMAN PRESCRIPTION DRUG Rough Pigweed Rough Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3317_45a21265-75ff-4634-a154-faff541e45d6 36987-3317 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3318_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3318 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3319_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3319 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3320_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3320 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3321_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3321 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3322_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3322 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3323_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3323 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3324_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3324 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3325_45a21265-75ff-4634-a154-faff541e45d6 36987-3325 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3326_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3326 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3327_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3327 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3328_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3328 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3329_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3329 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3330_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3330 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3331_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3331 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3332_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3332 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3333_45a21265-75ff-4634-a154-faff541e45d6 36987-3333 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA AXILLARIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3334_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3334 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA AXILLARIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3335_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3335 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA AXILLARIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3336_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3336 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA AXILLARIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3337_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3337 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA AXILLARIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3338_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3338 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA AXILLARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3339_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3339 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA AXILLARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3340_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3340 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA AXILLARIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3341_45a21265-75ff-4634-a154-faff541e45d6 36987-3341 HUMAN PRESCRIPTION DRUG Rabbitbush Rabbitbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3342_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3342 HUMAN PRESCRIPTION DRUG Rabbitbush Rabbitbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3343_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3343 HUMAN PRESCRIPTION DRUG Rabbitbush Rabbitbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3344_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3344 HUMAN PRESCRIPTION DRUG Rabbitbush Rabbitbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3345_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3345 HUMAN PRESCRIPTION DRUG Rabbitbush Rabbitbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3346_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3346 HUMAN PRESCRIPTION DRUG Rabbitbush Rabbitbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3347_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3347 HUMAN PRESCRIPTION DRUG Rabbitbush Rabbitbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3348_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3348 HUMAN PRESCRIPTION DRUG Rabbitbush Rabbitbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3349_45a21265-75ff-4634-a154-faff541e45d6 36987-3349 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3350_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3350 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3351_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3351 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3352_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3352 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3353_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3353 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3354_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3354 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3355_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3355 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3356_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3356 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3357_45a21265-75ff-4634-a154-faff541e45d6 36987-3357 HUMAN PRESCRIPTION DRUG Ailanthus Ailanthus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3358_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3358 HUMAN PRESCRIPTION DRUG Ailanthus Ailanthus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3359_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3359 HUMAN PRESCRIPTION DRUG Ailanthus Ailanthus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3360_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3360 HUMAN PRESCRIPTION DRUG Ailanthus Ailanthus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3361_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3361 HUMAN PRESCRIPTION DRUG Ailanthus Ailanthus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3362_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3362 HUMAN PRESCRIPTION DRUG Ailanthus Ailanthus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3363_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3363 HUMAN PRESCRIPTION DRUG Ailanthus Ailanthus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3364_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3364 HUMAN PRESCRIPTION DRUG Ailanthus Ailanthus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3365_45a21265-75ff-4634-a154-faff541e45d6 36987-3365 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3366_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3366 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3367_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3367 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3368_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3368 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3369_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3369 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3370_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3370 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3371_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3371 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3372_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3372 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3373_45a21265-75ff-4634-a154-faff541e45d6 36987-3373 HUMAN PRESCRIPTION DRUG Greasewood Greasewood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3374_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3374 HUMAN PRESCRIPTION DRUG Greasewood Greasewood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3375_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3375 HUMAN PRESCRIPTION DRUG Greasewood Greasewood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3376_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3376 HUMAN PRESCRIPTION DRUG Greasewood Greasewood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3377_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3377 HUMAN PRESCRIPTION DRUG Greasewood Greasewood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3378_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3378 HUMAN PRESCRIPTION DRUG Greasewood Greasewood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3379_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3379 HUMAN PRESCRIPTION DRUG Greasewood Greasewood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3380_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3380 HUMAN PRESCRIPTION DRUG Greasewood Greasewood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3384_afe81254-8c8f-4eb0-a914-81cafe13b7cd 36987-3384 HUMAN PRESCRIPTION DRUG Short Ragweed Pollen Short Ragweed Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19830408 BLA BLA102203 Nelco Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3385_afe81254-8c8f-4eb0-a914-81cafe13b7cd 36987-3385 HUMAN PRESCRIPTION DRUG Short Ragweed Pollen Short Ragweed Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19830408 BLA BLA102203 Nelco Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 40000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3387_afe81254-8c8f-4eb0-a914-81cafe13b7cd 36987-3387 HUMAN PRESCRIPTION DRUG Short Ragweed Pollen Short Ragweed Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19830408 BLA BLA102203 Nelco Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN .05 g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3388_afe81254-8c8f-4eb0-a914-81cafe13b7cd 36987-3388 HUMAN PRESCRIPTION DRUG Short Ragweed Pollen Short Ragweed Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19830408 BLA BLA102203 Nelco Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN .1 g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3389_45a21265-75ff-4634-a154-faff541e45d6 36987-3389 HUMAN PRESCRIPTION DRUG Tall Ragweed Tall Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA TRIFIDA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3390_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3390 HUMAN PRESCRIPTION DRUG Tall Ragweed Tall Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA TRIFIDA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3391_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3391 HUMAN PRESCRIPTION DRUG Tall Ragweed Tall Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA TRIFIDA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3392_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3392 HUMAN PRESCRIPTION DRUG Tall Ragweed Tall Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA TRIFIDA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3393_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3393 HUMAN PRESCRIPTION DRUG Tall Ragweed Tall Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA TRIFIDA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3394_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3394 HUMAN PRESCRIPTION DRUG Tall Ragweed Tall Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA TRIFIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3395_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3395 HUMAN PRESCRIPTION DRUG Tall Ragweed Tall Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA TRIFIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3396_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3396 HUMAN PRESCRIPTION DRUG Tall Ragweed Tall Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA TRIFIDA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3397_45a21265-75ff-4634-a154-faff541e45d6 36987-3397 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALSOLA KALI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3398_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3398 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALSOLA KALI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3399_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3399 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALSOLA KALI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3400_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3400 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALSOLA KALI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3401_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3401 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALSOLA KALI POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3402_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3402 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALSOLA KALI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3403_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3403 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALSOLA KALI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3404_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3404 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALSOLA KALI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3405_45a21265-75ff-4634-a154-faff541e45d6 36987-3405 HUMAN PRESCRIPTION DRUG Common Sagebrush Common Sagebrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3406_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3406 HUMAN PRESCRIPTION DRUG Common Sagebrush Common Sagebrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3407_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3407 HUMAN PRESCRIPTION DRUG Common Sagebrush Common Sagebrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3408_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3408 HUMAN PRESCRIPTION DRUG Common Sagebrush Common Sagebrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3409_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3409 HUMAN PRESCRIPTION DRUG Common Sagebrush Common Sagebrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3410_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3410 HUMAN PRESCRIPTION DRUG Common Sagebrush Common Sagebrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3411_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3411 HUMAN PRESCRIPTION DRUG Common Sagebrush Common Sagebrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3412_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3412 HUMAN PRESCRIPTION DRUG Common Sagebrush Common Sagebrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3413_45a21265-75ff-4634-a154-faff541e45d6 36987-3413 HUMAN PRESCRIPTION DRUG Saltbush Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3414_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3414 HUMAN PRESCRIPTION DRUG Saltbush Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3415_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3415 HUMAN PRESCRIPTION DRUG Saltbush Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3416_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3416 HUMAN PRESCRIPTION DRUG Saltbush Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3417_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3417 HUMAN PRESCRIPTION DRUG Saltbush Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3418_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3418 HUMAN PRESCRIPTION DRUG Saltbush Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3419_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3419 HUMAN PRESCRIPTION DRUG Saltbush Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3420_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3420 HUMAN PRESCRIPTION DRUG Saltbush Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3421_45a21265-75ff-4634-a154-faff541e45d6 36987-3421 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX ACETOSELLA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 36987-3422_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3422 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX ACETOSELLA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 36987-3423_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3423 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX ACETOSELLA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 36987-3424_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3424 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX ACETOSELLA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 36987-3425_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3425 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX ACETOSELLA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 36987-3426_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3426 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX ACETOSELLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 36987-3427_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3427 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX ACETOSELLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 36987-3428_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3428 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX ACETOSELLA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 36987-3429_45a21265-75ff-4634-a154-faff541e45d6 36987-3429 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3430_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3430 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3431_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3431 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3432_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3432 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3433_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3433 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3434_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3434 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3435_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3435 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3436_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3436 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3437_45a21265-75ff-4634-a154-faff541e45d6 36987-3437 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX CANESCENS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3438_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3438 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX CANESCENS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3439_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3439 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX CANESCENS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3440_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3440 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX CANESCENS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3441_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3441 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX CANESCENS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3442_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3442 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX CANESCENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3443_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3443 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX CANESCENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3444_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3444 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX CANESCENS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3445_45a21265-75ff-4634-a154-faff541e45d6 36987-3445 HUMAN PRESCRIPTION DRUG Wormwood Wormwook INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3446_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3446 HUMAN PRESCRIPTION DRUG Wormwood Wormwook INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3447_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3447 HUMAN PRESCRIPTION DRUG Wormwood Wormwook INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3448_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3448 HUMAN PRESCRIPTION DRUG Wormwood Wormwook INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3449_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3449 HUMAN PRESCRIPTION DRUG Wormwood Wormwook INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3450_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3450 HUMAN PRESCRIPTION DRUG Wormwood Wormwook INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3451_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3451 HUMAN PRESCRIPTION DRUG Wormwood Wormwook INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3452_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3452 HUMAN PRESCRIPTION DRUG Wormwood Wormwook INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 36987-3453_afe81254-8c8f-4eb0-a914-81cafe13b7cd 36987-3453 HUMAN PRESCRIPTION DRUG Short Ragweed Pollen Short Ragweed Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19830408 BLA BLA102203 Nelco Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN .1 g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 37000-003_1368cd73-f5d4-4334-94ce-0aa5c037268d 37000-003 HUMAN OTC DRUG Crest Pro-Health Complete (Fresh Mint) Sodium Fluoride RINSE ORAL 20100816 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE .0219 g/mL 37000-004_99835298-ac01-4344-b847-719ee5404e11 37000-004 HUMAN OTC DRUG Crest Pro-Health Complete (Clean Mint) Sodium Fluoride RINSE ORAL 20100816 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE .0219 g/mL 37000-005_6567efd0-d955-4a81-9eb5-7445ce5d2c1b 37000-005 HUMAN OTC DRUG Crest Cavity Protection Sodium Fluoride PASTE, DENTIFRICE DENTAL 19840802 OTC MONOGRAPH FINAL part355 Procter & Gamble Manfuacturing Company SODIUM FLUORIDE 1.5 mg/g 37000-006_a78606e7-9b46-4781-a570-5d8ccf662fee 37000-006 HUMAN OTC DRUG Crest Pro-Health For Me Sodium Fluoride RINSE ORAL 20100830 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE .022 g/mL 37000-007_1b35aa40-a488-4e94-9b6f-e34e5749fad8 37000-007 HUMAN OTC DRUG Crest Pro-Health For Me Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100830 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-010_55cc3e2c-2be2-4c7f-93f9-402174b7b09f 37000-010 HUMAN OTC DRUG Crest Pro-Health Clinical Gum Protection STANNOUS FLUORIDE PASTE, DENTIFRICE DENTAL 20110304 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 4.54 mg/g 37000-011_d4c45d50-cb06-4396-9586-da2077984bcd 37000-011 HUMAN OTC DRUG Crest Sensitivity Treatment and Protection Stannous Fluoride PASTE, DENTIFRICE DENTAL 20110301 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 4.54 mg/g 37000-013_63e1f192-ac8b-450d-b3ab-9c0b515c7b06 37000-013 HUMAN OTC DRUG Metamucil Therapy for Regularity Psyllium Husk POWDER ORAL 19890331 20160811 OTC MONOGRAPH NOT FINAL part334 The Procter & Gamble Manufacturing Company PSYLLIUM HUSK 3.4 g/11g 37000-016_4cd7774a-e328-43a6-b5d1-0081ffe27fc1 37000-016 HUMAN OTC DRUG Pepto-Bismol To Go Bismuth subsalicylate TABLET ORAL 20120301 OTC MONOGRAPH FINAL part335 Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 262 mg/1 37000-017_2ad03a7b-14c2-4c58-8019-fa1186b51611 37000-017 HUMAN OTC DRUG Pepto-Bismol and Pepto-Bismol To Go Bismuth Subsalicylate KIT 20120917 OTC MONOGRAPH FINAL part335 Procter & Gamble Manufacturing Company 37000-018_4efc2a32-c8df-42dc-8c0c-12da50921319 37000-018 HUMAN OTC DRUG Pepto-Bismol Bismuth subsalicylate TABLET ORAL 20040630 OTC MONOGRAPH FINAL part335 Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 525 mg/21 37000-019_46d97d76-3d99-4f97-8c89-ac2282593aa2 37000-019 HUMAN OTC DRUG Pepto-Bismol Max Strength Bismuth subsalicylate LIQUID ORAL 19890331 OTC MONOGRAPH FINAL part335 Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 1050 mg/30mL 37000-020_758c5168-ebcb-4d88-93b6-079ac02cbc4f 37000-020 HUMAN OTC DRUG Crest Complete Multi-benefit Whitening plus Scope Sodium fluoride PASTE, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-022_b7155279-d4f5-483e-8768-ac9d14db7203 37000-022 HUMAN OTC DRUG Crest Complete Multi-Benefit Whitening Plus Scope Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-023_8d0bdf7b-6d73-4f5f-b824-326ed15b212e 37000-023 HUMAN OTC DRUG Metamucil Therapy for Regularity Psyllium Husk POWDER ORAL 19890331 OTC MONOGRAPH NOT FINAL part334 The Procter & Gamble Manufacturing Company PSYLLIUM HUSK 3.4 g/12g 37000-024_594c00aa-c98a-4e6d-840f-2e992e67fb81 37000-024 HUMAN OTC DRUG Metamucil Therapy for regularity Psyllium Husk POWDER ORAL 19941215 OTC MONOGRAPH NOT FINAL part334 The Procter & Gamble Manufacturing Company PSYLLIUM HUSK 3.4 g/5.8g 37000-032_0c553834-fc22-4f40-b4e6-fababe930824 37000-032 HUMAN OTC DRUG Pepto-Bismol Bismuth subsalicylate SUSPENSION ORAL 19890331 OTC MONOGRAPH FINAL part335 Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 525 mg/30mL 37000-037_fede16c7-9e2a-44a5-a821-253ad0b801b7 37000-037 HUMAN OTC DRUG Crest Pro-Health Clinical Gum Protection Stannous Fluoride PASTE, DENTIFRICE DENTAL 20100830 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 4.54 mg/g 37000-044_66644e3c-3861-42c1-8b9c-f8dd7695c14e 37000-044 HUMAN OTC DRUG Crest Baking Soda and Peroxide Whitening with Tartar Protection Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130701 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.6 mg/g 37000-048_a457922a-7d4f-4dc1-9b3b-c4923f54ccf9 37000-048 HUMAN OTC DRUG Crest Pro-Health All-Around Protection Stannous Fluoride PASTE, DENTIFRICE DENTAL 20110930 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company STANNOUS FLUORIDE .00454 g/g 37000-049_e731859a-a0db-4730-9466-cc8bb3eae25c 37000-049 HUMAN OTC DRUG Kids Crest Cavity Protection Sparkle Fun Sodium Fluoride PASTE, DENTIFRICE DENTAL 20020905 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-052_94b6b39f-a775-431c-b699-3b861f0aa819 37000-052 HUMAN OTC DRUG Head and Shoulders Damage Rescue 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20121112 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-053_00e15cb2-5cd7-459d-b992-fa595ddf5a18 37000-053 HUMAN OTC DRUG Head and Shoulders Green Apple Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20120101 20150711 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/mL 37000-054_3b885ac6-02e9-49e1-87e0-85d3a6e396d6 37000-054 HUMAN OTC DRUG Head and Shoulders Conditioner Green Apple Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20120101 20160123 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC .5 g/mL 37000-055_96d04ec7-8a30-4518-aa78-802afebf9580 37000-055 HUMAN OTC DRUG Head and Shoulders 2in1 Green Apple Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20120101 20151215 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/mL 37000-056_418237bb-57e3-486c-91a7-a888aa687a79 37000-056 HUMAN OTC DRUG Head and Shoulders 2in1 Men with Old Spice Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20120601 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-057_0c434f65-26a8-456c-9e69-b7dbd26f2a06 37000-057 HUMAN OTC DRUG Head and Shoulders Conditioner Damage Rescue Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20120515 20151209 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC .5 g/mL 37000-058_5514e9e1-83c1-4f63-be9f-e952fef5e94c 37000-058 HUMAN OTC DRUG Head and Shoulders Damage Rescue Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20120515 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-059_2389368b-b32e-4a09-93f4-5842b2ec42cf 37000-059 HUMAN OTC DRUG Head and Shoulders Extra Strength Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20121101 20160701 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 20 mg/mL 37000-060_cff9e1fb-a3f4-4936-a3d7-8e94790006b0 37000-060 HUMAN OTC DRUG Head and Shoulders Purely Gentle Scalp Care Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130501 20160801 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 10 mg/mL 37000-061_2cd100c7-66c6-4eae-81fe-4325b6223af5 37000-061 HUMAN OTC DRUG Head and Shoulders 2in1 Purely Gentle Scalp Care Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130501 20160801 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 10 mg/mL 37000-062_7da2c865-49ec-4a77-8c60-dc8300613ee8 37000-062 HUMAN OTC DRUG Head and Shoulders Extra Strength Men Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20120523 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 2 g/100mL 37000-063_44a0b388-77df-405b-b71e-c65fa867408a 37000-063 HUMAN OTC DRUG Head and Shoulders Conditioner Classic Clean Pyrithione Zinc LOTION TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 5 mg/mL 37000-064_aa16b174-2ab2-4b46-866c-e352179e8685 37000-064 HUMAN OTC DRUG Head and Shoulders Conditioner Green Apple Pyrithione Zinc LOTION TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 5 mg/mL 37000-065_ab0b2ec4-1a48-4791-a8d6-6862a1243142 37000-065 HUMAN OTC DRUG Head and Shoulders Conditioner Dry Scalp Pyrithione Zinc LOTION TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 5 mg/mL 37000-066_590dc13f-21e2-4ca0-bf3f-343e66f738ee 37000-066 HUMAN OTC DRUG Head and Shoulders Conditioner Itchy Scalp Pyrithione Zinc LOTION TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 5 mg/mL 37000-067_0061f4c4-1e3b-4e68-acca-c1b43b5325e1 37000-067 HUMAN OTC DRUG Head and Shoulders Conditioner Smooth and Silky Pyrithione Zinc LOTION TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 5 mg/mL 37000-068_be75dc8c-60ce-4caa-a543-32829c6e0e60 37000-068 HUMAN OTC DRUG Head and Shoulders Conditioner Damage Rescue Pyrithione Zinc LOTION TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 5 mg/mL 37000-069_dd00ed9b-5edd-4171-a055-051c1a0de82e 37000-069 HUMAN OTC DRUG Head and Shoulders Conditioner Full and Strong Pyrithione Zinc LOTION TOPICAL 20130912 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 5 mg/mL 37000-070_06235ba3-e589-4d9f-b6c7-28a22cd0cad1 37000-070 HUMAN OTC DRUG Head and Shoulders 2in1 Classic Clean Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 10 mg/mL 37000-071_1fa13119-0c23-48df-aca1-09827c577fe2 37000-071 HUMAN OTC DRUG Head and Shoulders Classic Clean Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 10 mg/mL 37000-072_8f3f4004-3c82-4926-8ce6-b1a1ba452089 37000-072 HUMAN OTC DRUG Head and Shoulders Citrus Breeze Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 10 mg/mL 37000-073_b90d7c9e-78b2-4666-baa7-49b180d2e89e 37000-073 HUMAN OTC DRUG Head and Shoulders 2in1 Citrus Breeze Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 10 mg/mL 37000-074_3885501c-47a3-499b-bc97-7ace3441b401 37000-074 HUMAN OTC DRUG Head and Shoulders Purely Gentle Scalp Care Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 mg/100mL 37000-075_f3e73fad-4132-4fb8-a52f-114c50ae5987 37000-075 HUMAN OTC DRUG Head and Shoulders Purely Gentle Scalp Care 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-076_a3046809-2fe4-4d88-b393-6815bf83730a 37000-076 HUMAN OTC DRUG Head and Shoulders Ocean Lift 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-077_76f264f1-b6c0-466c-8760-13223b3f307e 37000-077 HUMAN OTC DRUG Head and Shoulders Green Apple Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-078_58bdd2c4-2baf-4023-a06a-8d86c44cdb0c 37000-078 HUMAN OTC DRUG Head and Shoulders Green Apple 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-079_5c109578-e3da-4928-a1be-3242474f6aaf 37000-079 HUMAN OTC DRUG Head and Shoulders Itchy Scalp Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-080_38ca5669-bfe5-4084-b414-4aea69cc4d7c 37000-080 HUMAN OTC DRUG Dolce and Gabbana The Foundation Perfect Matte Broadspectrum SPF 20 All shades Ensulizole LIQUID TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company ENSULIZOLE 30 mg/mL 37000-081_7008a32c-f04c-4b02-9dd7-f813a72fefc8 37000-081 HUMAN OTC DRUG Head and Shoulders Itchy Scalp 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-082_65e271d6-1953-4c00-b7bc-be37ecd654fa 37000-082 HUMAN OTC DRUG Head and Shoulders Extra Volume Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-083_3177c047-b9db-4ec9-978f-c92d0fe7571b 37000-083 HUMAN OTC DRUG Head and Shoulders Extra Volume 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 10 mg/mL 37000-084_dd31ed60-07e8-4259-b700-24562958df06 37000-084 HUMAN OTC DRUG Head and Shoulders Men Full and Thick Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-085_ebc2dfae-40e6-41a8-8e27-8d7e98b0e3a6 37000-085 HUMAN OTC DRUG Head and Shoulders Men Full and Thick 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-086_818ea28a-8e96-4098-b4dd-1758c9074772 37000-086 HUMAN OTC DRUG Head and Shoulders Full and Strong Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-087_22631138-af5e-4ffc-bbef-bb5745b8ef21 37000-087 HUMAN OTC DRUG Head and Shoulders Full and Strong 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-088_08c7ef26-4017-470f-a285-3ab02e8697ad 37000-088 HUMAN OTC DRUG Head and Shoulders Men Deep Clean Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-089_adbddd57-e3ee-4908-b825-6328cbb3ecee 37000-089 HUMAN OTC DRUG Head and Shoulders Men Deep Clean 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-090_1d1ca75c-528e-44c8-8f9b-b21cc8cd9daf 37000-090 HUMAN OTC DRUG Head and Shoulders Men Total Care All in 1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-091_cb23b7b5-b285-47b9-8414-2d1ca5e3097e 37000-091 HUMAN OTC DRUG Secret Invisible Solid Powder Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20050801 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g 37000-092_d461e9fb-c1c3-4e3b-920a-1b5604c6f9f5 37000-092 HUMAN OTC DRUG Head and Shoulders Dry Scalp Care Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-093_64f350a0-e2a6-4f67-a977-038ecb85ef74 37000-093 HUMAN OTC DRUG Head and Shoulders Dry Scalp Care 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-094_c29b7087-ee5b-4a89-8c07-e0e79f63867f 37000-094 HUMAN OTC DRUG Head and Shoulders Smooth and Silky Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-095_ab62c8c7-7093-4a5d-a7f1-c0dd469b03a0 37000-095 HUMAN OTC DRUG Head and Shoulders Smooth and Silky 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-096_eeb79d76-6eef-4853-b4d2-e7dd068419d3 37000-096 HUMAN OTC DRUG Head and Shoulders Men Refresh Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-097_5b4ed6b6-7290-4e9c-87a2-894dc38c5ba9 37000-097 HUMAN OTC DRUG Head and Shoulders Men Refresh 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-098_6abb1efa-c2f1-4fcf-8806-c5515ee98d96 37000-098 HUMAN OTC DRUG Head and Shoulders Men Active Sport Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-099_6af4f026-8ad2-4ea4-b26b-1947d67e7b29 37000-099 HUMAN OTC DRUG Head and Shoulders Men Active Sport 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-100_534301e7-30b3-4fc7-96db-4548725ce054 37000-100 HUMAN OTC DRUG Head and Shoulders Ocean Lift Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-101_5b058bbe-500c-4e3c-a98d-d0ef67d7327f 37000-101 HUMAN OTC DRUG Secret Scent Expressions Invisible Solid Ooh-La-La Lavender Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g 37000-102_40916b2b-3911-4364-a03c-3b258a1b0e5b 37000-102 HUMAN OTC DRUG Head and Shoulders Men Old Spice Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20131201 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-103_9718b924-7a24-4d8d-9951-ecf13a8ecc47 37000-103 HUMAN OTC DRUG Secret Fresh Effects Invisible Spring Cotton Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20120101 20151119 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .18 g/g 37000-104_15b2bf30-18b1-4d2b-9853-cea2aa72fa6d 37000-104 HUMAN OTC DRUG Secret Clinical Strength Soothing Calming Aloe Scent Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20121101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .2 g/g 37000-106_4d9f2a80-32e3-4205-914e-d47edb29be9f 37000-106 HUMAN OTC DRUG Head and Shoulders Dual Sachets Classic Clean Pyrithione Zinc KIT 20130927 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company 37000-107_642f303d-4b4b-4896-b690-298bcb63a6e2 37000-107 HUMAN OTC DRUG Secret Scent Expressions Crystal Clear Passionista Fruit Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20110101 20150110 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .16 g/g 37000-108_7b99cd10-09d0-46f3-9acc-0c75a285722c 37000-108 HUMAN OTC DRUG Head and Shoulders Dual Sachets Green Apple Pyrithione Zinc KIT 20140127 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company 37000-109_8acca8cb-15ff-470a-aca6-76a93be57e16 37000-109 HUMAN OTC DRUG Secret Scent Expressions Crystal Clear Cocoa Butter Kiss Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .16 g/g 37000-110_9753f5fa-d902-4876-b601-ce99e42db994 37000-110 HUMAN OTC DRUG Secret Outlast and Olay Smooth Protecting Powder Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130923 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g 37000-111_693f5075-4122-48cf-b940-49754d3336e9 37000-111 HUMAN OTC DRUG Secret Outlast and Olay Smooth Completely Clean Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130923 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g 37000-112_88b3b108-3202-4eab-941b-b9e2928b9c09 37000-112 HUMAN OTC DRUG Secret Outlast and Olay Smooth Sport Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130923 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g 37000-113_3c363cc6-0665-4efa-ba21-a23004036737 37000-113 HUMAN OTC DRUG Secret Scent Expressions Crystal Clear So Very Summerberry Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .16 g/g 37000-114_9ff46802-cd9a-4b8e-a5a0-64b737a0dcd4 37000-114 HUMAN OTC DRUG Head and Shoulders Dual Sachets Smooth and Silky Pyrithione Zinc KIT 20140127 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company 37000-115_1c62113d-9b17-4d35-9806-71da171af7be 37000-115 HUMAN OTC DRUG Head and Shoulders Dual Sachets Full and Strong Pyrithione Zinc KIT 20140127 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company 37000-116_caa6a300-e8b4-4394-9512-19a317aab1f2 37000-116 HUMAN OTC DRUG Secret Scent Expressions Crystal Clear Truth or Pear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .16 g/g 37000-117_f38e306d-49c0-4e04-aefd-e117a9fdb63c 37000-117 HUMAN OTC DRUG Secret Fresh Effects Invisible Soothing Cucumber Scent Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20121101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g 37000-118_080e7fe9-52f9-40ba-873b-8b6339a3570a 37000-118 HUMAN OTC DRUG Secret Brazil Clear Rainforest Mist Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20140130 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-119_e9684a60-7af9-4b2e-b744-1c626b07436a 37000-119 HUMAN OTC DRUG Secret Paris Clear Romantic Rose Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20140130 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-120_5a8f65a0-82b5-47fe-9d11-0ddf363021ca 37000-120 HUMAN OTC DRUG Secret Hawaii Clear Citrus Breeze Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20140130 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-121_7b5046f5-eb6c-42e1-b920-79ba77e92c32 37000-121 HUMAN OTC DRUG Secret Clinical Strength Cocoa Butter Kiss Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120702 20150801 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .2 g/g 37000-122_1589f50b-6410-4603-abf4-9d1c5cf82f1c 37000-122 HUMAN OTC DRUG Secret Clinical Strength Fearlessly Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120702 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .2 g/g 37000-123_c2c94942-047e-44ba-9fe0-88d42149da51 37000-123 HUMAN OTC DRUG Secret Invisible Bora Bora Fresh Orchid Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20140706 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 37000-124_28661a2b-67a0-43cd-a63c-5d6f1f0d0490 37000-124 HUMAN OTC DRUG Secret Clinical Strength Invisible Sensitive Hypoallergenic Unscented Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20141210 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 37000-125_f7f1ad7a-3e6a-4980-9a66-0764418d4283 37000-125 HUMAN OTC DRUG Secret Outlast and Olay Smooth Protecting Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g 37000-126_3250ddf7-a488-4cc3-abf2-4517cc5364a5 37000-126 HUMAN OTC DRUG Secret Outlast and Olay Smooth Completely Clean Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g 37000-127_60078cf0-6918-4925-b43b-da5d49241fb8 37000-127 HUMAN OTC DRUG Secret Clinical Strength Invisible Stress Response Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20141210 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 37000-128_99e52be3-7058-42b1-bc98-54f8e0b60f66 37000-128 HUMAN OTC DRUG Secret Clinical Strength Advanced Powder Protection ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20061201 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .2 g/g 37000-129_4564eb6d-06fb-47fb-9aac-86e432617eee 37000-129 HUMAN OTC DRUG Secret Antiperspirant/Deodorant Powder Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120201 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .15 g/g 37000-130_67e4bc21-ff80-44b5-8597-5d1d9abb975d 37000-130 HUMAN OTC DRUG Secret Clinical Strength Invisible With Olay Beauty Skin Conditioners Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20141210 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 37000-131_a13be758-d900-43a6-9d3f-d89f90d9f315 37000-131 HUMAN OTC DRUG Secret Antiperspirant/Deodorant Shower Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .15 g/g 37000-132_410af0d4-327e-4af4-9be7-5f23ca9240e1 37000-132 HUMAN OTC DRUG Secret Clinical Strength Light and Fresh ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20061201 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .2 g/g 37000-134_2da27b90-3a07-4a72-a1e8-f20c1eb4c947 37000-134 HUMAN OTC DRUG Secret Antiperspirant Powder Fresh Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20070401 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE .24 g/g 37000-135_926db827-b311-479d-8f61-2e6e299c5330 37000-135 HUMAN OTC DRUG Secret Roll-On Powder Fresh ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20010121 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 126 g/mL 37000-136_5abf4380-5285-4deb-adfa-23ebf455277c 37000-136 HUMAN OTC DRUG Secret Antiperspirant Spring Breeze Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20070401 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE .24 g/g 37000-137_f9c2289a-e784-449d-82d7-915c4b0a7257 37000-137 HUMAN OTC DRUG Secret Clinical Strength Sensitive Skin/Hypoallergenic Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20080101 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .2 g/g 37000-138_e23aba3a-4f3c-4300-8dbd-2ee6d041e17b 37000-138 HUMAN OTC DRUG Secret Clinical Strength Sport Marathon Fresh ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20080401 20160215 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .2 g/g 37000-140_35b3f683-ec41-4df9-a89d-cf09cdc7e779 37000-140 HUMAN OTC DRUG Secret Brazil Invisible Rainforest Mist Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20140130 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 37000-141_4a99151b-1817-4a20-86f9-707a3785aed4 37000-141 HUMAN OTC DRUG Secret Paris Invisible Romantic Rose Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20140130 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 37000-142_b21733ca-3461-44df-a11c-825ef5bf97ee 37000-142 HUMAN OTC DRUG Secret Hawaii Invisible Citrus Breeze Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20140130 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 37000-143_6c749f91-620f-466c-bc13-7dfad611d5e4 37000-143 HUMAN OTC DRUG Old Spice Red Zone Collection Swagger Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20140910 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-144_fd0ad8b5-7722-430b-9b6f-037daa689dac 37000-144 HUMAN OTC DRUG Old Spice Red Zone Collection After Hours Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20140910 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-145_646758ae-95d8-402c-8c2b-f05a92ac1118 37000-145 HUMAN OTC DRUG Old Spice Red Zone Collection Swagger Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140910 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g 37000-146_72c0efb5-28cb-4081-bea0-01b58858f91c 37000-146 HUMAN OTC DRUG Old Spice Fresher Collection Amber with Black Currant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140910 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g 37000-147_2e9b3e72-3fdd-4a01-bc51-d09b5d72166f 37000-147 HUMAN OTC DRUG Old Spice Fresher Collection Citron with Sandalwood Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140910 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g 37000-148_0ed2210c-43f7-4cf1-9a66-7dfcabaa2abd 37000-148 HUMAN OTC DRUG Old Spice Fresher Collection Timber with Mint Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140710 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g 37000-149_c59c9af8-55b6-4751-be58-36e2d2ab117b 37000-149 HUMAN OTC DRUG Old Spice Classic Original Scent Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20010201 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .15 g/g 37000-150_a541f9f5-e27b-4f22-ab16-4bacffa4e572 37000-150 HUMAN OTC DRUG Old Spice Red Zone Sweat Defense Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20091201 20161101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g 37000-151_12b667d2-5ba3-4739-b650-7e28a0f550e3 37000-151 HUMAN OTC DRUG Old Spice Wild Collection Bearglove Invisible Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130730 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g 37000-152_73e87c41-186f-4fb8-beb0-bd4c797a9a1e 37000-152 HUMAN OTC DRUG Old Spice Wild Collection Lionpride Invisible Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130730 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g 37000-153_d276d2f4-6a43-40fc-bc35-15959ada4f84 37000-153 HUMAN OTC DRUG Old Spice Original High Endurance Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140310 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g 37000-154_4fe62dc8-e985-4ba8-bd55-daed94b6125e 37000-154 HUMAN OTC DRUG Old Spice High Endurance Pure Sport Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120501 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .17 g/g 37000-155_e97c8a87-a2f6-48fa-8d2b-2f831f0ab5b9 37000-155 HUMAN OTC DRUG Old Spice Wild Collection Wolfthorn Invisible Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20121101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g 37000-156_d98ef986-9b5a-4b2b-a746-3974002ea921 37000-156 HUMAN OTC DRUG Old Spice Wild Collection Hawkridge Invisible Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20121101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g 37000-157_308f4795-7b39-4448-96cb-2abfb3e4a506 37000-157 HUMAN OTC DRUG Old Spice Wild Collection Foxcrest Invisible Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20121101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g 37000-158_d3dfd245-507c-4881-aa41-4e31a19c9c69 37000-158 HUMAN OTC DRUG Old Spice Fresh High Endurance Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140310 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g 37000-162_32fa7028-6f2d-4c5a-846a-f37eeaea3d06 37000-162 HUMAN OTC DRUG Old Spice High Endurance Clear Pure Sport Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20140917 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Co. ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-163_8467aa32-0d99-4f21-b7fd-50e84fa92cd8 37000-163 HUMAN OTC DRUG Old Spice Sweat Defense Fiji Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20141001 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 37000-164_ac33ddca-15ea-4b6c-9315-5b6c53ad700c 37000-164 HUMAN OTC DRUG Old Spice Sweat Defense Bearglove Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20141001 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 37000-165_034041b0-0864-4e18-a6cb-f78366719f5f 37000-165 HUMAN OTC DRUG Old Spice Sweat Defense Timber Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20141001 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 37000-176_b426b2a1-a660-42af-9480-d92dfcae1af6 37000-176 HUMAN OTC DRUG Secret Invisible Solid Shower Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20010101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g 37000-177_4f0586cc-888f-4f62-adb1-dbbc3125df4e 37000-177 HUMAN OTC DRUG Secret Invisible Solid Spring Breeze Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20010101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g 37000-178_7f42f534-a320-4daa-9378-e988e64f8fef 37000-178 HUMAN OTC DRUG Secret Invisible Solid Unscented Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20010101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g 37000-179_43c9f4a6-95aa-4599-b30e-7ea40c2402db 37000-179 HUMAN OTC DRUG Old Spice Red Zone Sweat Defense Pure Sport Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20091201 20161101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g 37000-180_6b7f1ddf-9362-45b9-8119-cfd758fedc40 37000-180 HUMAN OTC DRUG Old Spice Red Zone Sweat Defense After Hours Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20091201 20161101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g 37000-181_97ad2619-ed4b-47d7-9d53-8e14d6d629f2 37000-181 HUMAN OTC DRUG Gillette Clinical Endurance Clear Cool Wave Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20131101 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .2 g/g 37000-182_41ea6019-1a26-4c60-a8f0-9a1d6b19dde7 37000-182 HUMAN OTC DRUG Gillette Clinical Sport Clear Power Rush Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20131115 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .2 g/g 37000-183_2f38ebc0-109c-43e7-a78c-b6f86aef78f8 37000-183 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FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .028 g/g 37000-188_b5e7f103-8c82-4b4e-b016-371b5b4eb56a 37000-188 HUMAN OTC DRUG Gillette Endurance Clear Brisa Tropical Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20141220 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-189_f08c1153-7ebe-4951-9e2c-7f09b8cdf11e 37000-189 HUMAN OTC DRUG Gillette Clinical Advanced Sport Triumph Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20141103 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g 37000-190_4801eef2-2843-4b47-b324-ce6676bbf6e7 37000-190 HUMAN OTC DRUG Gillette Endurance Power Beads Cool Wave Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20141220 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-191_7200c8e3-3c8a-4d3f-8c3e-866e2068fa6a 37000-191 HUMAN OTC DRUG Gillette Sport Power Beads Power Rush Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20141220 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-192_8a2fdfb1-d51c-43b7-8697-a2c087d9b438 37000-192 HUMAN OTC DRUG Gillette Sport Power Rush Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20141220 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-193_2d5a1023-6e54-445b-bfbf-1aebdb0d8d5c 37000-193 HUMAN OTC DRUG Gillette Sport Sport Triumph Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20141220 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-194_bf9f0e3d-b61c-4755-ad47-41b5875141f6 37000-194 HUMAN OTC DRUG Gillette Endurance Arctic Ice Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20141220 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-195_ce0fab84-6a3f-493d-9f80-a29bce985066 37000-195 HUMAN OTC DRUG Old Spice High Endurance Clear Pure Sport Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20020327 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .16 g/g 37000-197_0b24e276-6310-46c1-a18c-d2235bb6363f 37000-197 HUMAN OTC DRUG Gillette Endurance Cool Wave Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20141220 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-198_1df38460-d712-4ae7-be99-10f8601e6b5d 37000-198 HUMAN OTC DRUG Gillette Sport Undefeated Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20141220 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-199_1d1a55eb-3402-4d93-8436-d8356d0b4d80 37000-199 HUMAN OTC DRUG Old Spice High Endurance Pure Sport Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20020411 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE .23 g/g 37000-202_9b4dd98c-9ee2-4b50-ba94-b33248077f36 37000-202 HUMAN OTC DRUG Olay Fresh Effects BB Broad Spectrum SPF 15 Light to Medium Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20140207 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 40; 45; 26 mg/mL; mg/mL; mg/mL; mg/mL 37000-204_6a7bbdf3-4044-4047-a47e-70aaec1127af 37000-204 HUMAN OTC DRUG Old Spice Fresh Collection Zanzibar Anti-Perspirant and Deodorant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140102 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g 37000-205_e4e2a15a-0b7b-42e5-84f4-6e3d10739abd 37000-205 HUMAN OTC DRUG Old Spice Red Zone Collection Aqua Reef Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140110 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g 37000-206_8212489c-17df-4873-9980-3a6e24743cdc 37000-206 HUMAN OTC DRUG Old Spice Game Day High Endurance Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140110 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g 37000-207_b7ce96bc-3d07-46fa-b21d-1832bc23fb91 37000-207 HUMAN OTC DRUG Old Spice Playmaker High Endurance Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140110 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g 37000-210_2ed21ed3-8e60-4ccd-b8ad-dd5263f8661f 37000-210 HUMAN OTC DRUG Secret Scent Expressions Clear Ooh La La Lavender Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20081201 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-211_509f3f0a-d1ef-40c5-aca5-758ad08fe437 37000-211 HUMAN OTC DRUG Secret Scent Expressions Clear Va Va Vanilla Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20081201 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-224_e500b76c-9258-4fd5-ad29-2f2042f9dfc5 37000-224 HUMAN OTC DRUG Olay Complete Tinted Moisturizer Broad Spectrum SPF 15 Light to Medium Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20140819 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL 37000-225_0dbb52e5-cef7-40aa-8812-2aa417a3cf45 37000-225 HUMAN OTC DRUG Olay Complete Tinted Moisturizer Broad Spectrum SPF 15 Fair to Light Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20140819 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL 37000-231_a168b786-7462-454a-9388-9f5e52885f19 37000-231 HUMAN OTC DRUG Olay Age Defying Mature Skin Broad Spectrum SPF 15 Octinoxate and Zinc Oxide LOTION TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; ZINC OXIDE 6; 3 g/100mL; g/100mL 37000-232_57f4c0da-b291-47d3-a54e-217d39f74a4b 37000-232 HUMAN OTC DRUG Olay Professional ProX Age Repair Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 1.5; 5; 2.6; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 37000-233_8f126069-6e6a-4a96-94af-6006875873cd 37000-233 HUMAN OTC DRUG Olay Complete All Day Moisturizer Broad Spectrum SPF 15 Sensitive Octinoxate and Zinc Oxide LOTION TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; ZINC OXIDE 6; 3 g/100mL; g/100mL 37000-234_9fc81efb-97b9-4855-a94d-cd6c21ae3a90 37000-234 HUMAN OTC DRUG Olay Age Defying Mature Skin Protective Renewal Broad Spectrum SPF 15 Octinoxate and Zinc Oxide LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; ZINC OXIDE 6; 3 g/100mL; g/100mL 37000-235_20542a6a-e029-444b-a8a4-5526242e1062 37000-235 HUMAN OTC DRUG Olay Moisturizer Broadspectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 3; 5; 2.6 g/100g; g/100g; g/100g; g/100g 37000-237_229c42c3-1016-4ea8-ba4c-53529977113d 37000-237 HUMAN OTC DRUG Olay Acne Control Face Wash Salicylic Acid LIQUID TOPICAL 20101101 20151101 OTC MONOGRAPH FINAL part333D Procter & Gamble Manufacturing Company SALICYLIC ACID 20 mg/mL 37000-238_0d3a590c-8777-43cf-879b-84578201a632 37000-238 HUMAN OTC DRUG Olay Complete All Day Moisturizer Broad Spectrum SPF 30 Sensitive Skin Octinoxate, Octisalate, Octocrylene, and Zinc Oxide LOTION TOPICAL 20120601 20160731 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 7.5; 2.5; 2.5; 6 g/100mL; g/100mL; g/100mL; g/100mL 37000-240_2dac1969-4185-4066-8d1e-b998ca723dd3 37000-240 HUMAN OTC DRUG Olay Age Defying Anti-Wrinkle Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 29.4; 49; 49; 25.48 mg/mL; mg/mL; mg/mL; mg/mL 37000-242_163d634c-44ce-4cce-9825-62ec9400b9ca 37000-242 HUMAN OTC DRUG Olay Total Effects Moisturizer Plus Serum Duo Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20121105 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 40; 45; 26 mg/mL; mg/mL; mg/mL; mg/mL 37000-246_3d6d6504-cad4-469b-a600-81cadc62bdc4 37000-246 HUMAN OTC DRUG Olay Total Effects Fragrance Free Moisturizer Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20120501 20150731 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .03; .05; .05; .026 mg/100mL; mg/100mL; mg/100mL; mg/100mL 37000-247_4f7a259f-0523-48b9-bc6d-061a93f0e759 37000-247 HUMAN OTC DRUG Olay Fresh Effects BB Broad Spectrum SPF 15 Fair to Light Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20121101 20150724 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 40; 45; 26 mg/mL; mg/mL; mg/mL; mg/mL 37000-248_91119948-b171-4c2e-9684-97ddbe599106 37000-248 HUMAN OTC DRUG Olay Fresh Effects BB Broad Spectrum SPF 15 Light to Medium Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20121101 20151008 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 40; 45; 26 mg/mL; mg/mL; mg/mL; mg/mL 37000-249_53c64fff-3981-4d9b-984b-2e75565a2a14 37000-249 HUMAN OTC DRUG Olay Professional ProX Anti-Oxidant Sheer Daily Moisturizer Broad Spectrum SPF 35 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121210 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 9; 4.5; 2.6; 2 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 37000-251_b4dc42d4-bb04-4c2b-ae53-5017e6ee30ad 37000-251 HUMAN OTC DRUG Secret Soothing Effects Invigorating Rain Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20100101 20150101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g 37000-253_d58e85ab-d4cb-41e4-a3c6-5d6caa65e509 37000-253 HUMAN OTC DRUG Secret Outlast Invisible Protecting Powder ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g 37000-257_8124576a-6c9a-49c3-a35d-0a7e8ae45c6a 37000-257 HUMAN OTC DRUG Olay Professional ProX Tone Correcting Protocol Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone KIT 20121210 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company 37000-258_99dc49e1-fefe-4577-b779-c8ef445bc582 37000-258 HUMAN OTC DRUG Secret Invisible Solid Sheer Clean Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20090101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g 37000-260_a0fb6317-f357-4723-a4c1-f21e1e193cb6 37000-260 HUMAN OTC DRUG Olay Total Effects Moisturizer Plus Serum Duo Fragrance Free Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20121215 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 40; 45; 26 mg/mL; mg/mL; mg/mL; mg/mL 37000-263_b487b7aa-b709-408f-9deb-23c0a2b0afbb 37000-263 HUMAN OTC DRUG Gillette Clear Cool Wave Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20080501 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .16 g/g 37000-264_2a7a68ea-d816-4ced-a2dc-7fc816b2011b 37000-264 HUMAN OTC DRUG Gillette Sport Clear and Refreshing Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20080501 20150303 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .16 g/g 37000-265_4223a219-53b7-48f3-95b7-56a772eeb067 37000-265 HUMAN OTC DRUG Gillette Clear Arctic Ice Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20080501 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .16 g/g 37000-267_0378cb6e-12e7-4e9e-8e11-6060c219d1fd 37000-267 HUMAN OTC DRUG Gillette Odor Shield Invisible Arctic Ice Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20121201 20150711 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g 37000-268_8ac3da03-50cb-455c-9f0f-3cb1702897a7 37000-268 HUMAN OTC DRUG Gillette Clear Power Rush Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20080501 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .16 g/g 37000-269_bf22f5ee-7e54-4ed3-983c-30252295ec1b 37000-269 HUMAN OTC DRUG Gillette Power Beads Cool Wave ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY STICK TOPICAL 20070620 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .16 g/g 37000-270_053d45b6-33a4-4107-b71a-35e9dd8695a7 37000-270 HUMAN OTC DRUG Gillette Power Beads Power Rush ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY STICK TOPICAL 20070620 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .16 g/g 37000-272_9cbc293e-c16d-4818-a0b7-87eb64a16d9f 37000-272 HUMAN OTC DRUG Gillette Odor Shield Sport Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120113 20151121 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g 37000-273_4d98bdac-f676-493e-acc6-d535d289db45 37000-273 HUMAN OTC DRUG Gillette Odor Shield Invisible Cool Wave Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20121201 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g 37000-274_7d076b25-5ef6-4c57-85ef-30b28ec2cf7c 37000-274 HUMAN OTC DRUG Gillette Fusion ProSeries Instant Hydration Moisturizer Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .03; .05; .05; .026 mL/100mL; mL/100mL; mL/100mL; mL/100mL 37000-275_8ae097d0-2d2d-4aa8-b8ce-6cd9dab438a0 37000-275 HUMAN OTC DRUG Olay Complete All Day Moisture Sensitive with Broad Spectrum SPF 15 Octinoxate and Zinc Oxide CREAM TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; ZINC OXIDE 6; 3 g/100g; g/100g 37000-277_fade21db-eaa2-4d54-a315-00ce18bbe488 37000-277 HUMAN OTC DRUG Olay Complete All Day Moisture Normal Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 3; 5; 2.6 g/100g; g/100g; g/100g; g/100g 37000-278_fa96813b-1e62-44b3-b158-a2da132afffb 37000-278 HUMAN OTC DRUG Olay Regenerist Regenerating Moisture Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL 37000-281_f96b7701-20d7-4811-9363-91a82ec91506 37000-281 HUMAN OTC DRUG Olay Complete All Day Moisturizer Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 3; 5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL 37000-282_92216d26-1264-45c6-a800-cb3485bd4f1d 37000-282 HUMAN OTC DRUG Olay Regenerist DNA Superstructure Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120601 20160515 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 1.5; 5; 2.6; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 37000-283_309504a8-3ef6-4cf4-b1e5-829daba94e04 37000-283 HUMAN OTC DRUG Olay Regenerist Regenerating Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .15; .05; .027; .06 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL 37000-284_05dbe634-a439-48f9-825c-9b27fa0c7fcd 37000-284 HUMAN OTC DRUG Olay Fresh Effects Clear Skin Spot Zinger Salicylic Acid LOTION TOPICAL 20140508 OTC MONOGRAPH FINAL part333D Procter & Gamble Manufacturing Company SALICYLIC ACID 2 g/100mL 37000-285_d770d7bb-6c34-4490-91cf-351b7843ac00 37000-285 HUMAN OTC DRUG Olay Total Effects Feather Weight Moisturizer with Sunscreen Broadspectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL 37000-286_dea27fca-b1b1-47e3-bf0e-6a157a9659c4 37000-286 HUMAN OTC DRUG Gillette Clinical Strength All Day Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20080701 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .2 g/g 37000-287_cdcc02cd-fbdc-46ac-bffb-0aec2753e75e 37000-287 HUMAN OTC DRUG Gillette Clinical Sport Triumph Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20071201 20160917 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g 37000-290_9aae8d40-4367-4c24-8057-08f7edf0bc40 37000-290 HUMAN OTC DRUG Secret Clinical Strength Fresh Water Orchid ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .2 g/g 37000-291_29f488fe-2025-428c-8d9a-a0ccb3aa5316 37000-291 HUMAN OTC DRUG Secret Clinical Strength Ooh La La Lavender ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .2 g/g 37000-292_dca7de8f-7fb1-47e6-9bc4-aa4007cd134a 37000-292 HUMAN OTC DRUG Olay Total Effects Feather Weight Moisturizer with Sunscreen Broadspectrum SPF 15 Fragrance Free Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL 37000-293_b1fd7b08-63d3-44d9-9d05-30b8249ba99a 37000-293 HUMAN OTC DRUG Olay Fresh Effects Clear Skin Acne Hater Deep Scrub Salicylic Acid LOTION TOPICAL 20140508 OTC MONOGRAPH FINAL part333D Procter & Gamble Manufacturing Company SALICYLIC ACID 2 g/100mL 37000-298_bdc0ac6f-d4fa-4872-b5f8-90f7a2a093e5 37000-298 HUMAN OTC DRUG Olay Fresh Effects Soak Up the Sun Protection Broadspectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL 37000-300_24684eb3-6c84-400e-ab77-2489375f46b5 37000-300 HUMAN OTC DRUG Head and Shoulders Treatment Full and Strong 2 Minute Strengthener Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20131017 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 7.5 mg/mL 37000-301_bad884e6-8ab3-4a13-992e-a9fe8a2b1ab9 37000-301 HUMAN OTC DRUG Head and Shoulders Treatment Dry Scalp Care 2 Minute Moisturizer Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20131017 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 7.5 mg/mL 37000-302_947d2337-c9a9-4583-a6dd-3053d70573c4 37000-302 HUMAN OTC DRUG Head and Shoulders Treatment Damage Rescue 2 Minute Repair Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20131017 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 7.5 mg/mL 37000-306_c2ac491e-368b-4177-ab55-93a279ade9a5 37000-306 HUMAN OTC DRUG Secret Invisible Solid Clean Lavender ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g 37000-307_4e9e623f-d863-4c6d-919f-d11a1765e0ad 37000-307 HUMAN OTC DRUG Secret Clinical Strength Stress Response Serene Citrus Scent Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20121215 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .2 g/g 37000-310_da477393-5d07-41f2-9586-3995ef414be4 37000-310 HUMAN OTC DRUG Secret Scent Expresssions Invisible Pasion de tango Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20121215 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g 37000-311_540425cf-71a1-4998-9238-9be49c5b6aa1 37000-311 HUMAN OTC DRUG Secret Scent Expresssions Clear Pasion de tango Aluminum Zirconium Octachlorohydrex Gly STICK TOPICAL 20121215 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .16 g/g 37000-312_28d867e3-f2fc-4c14-b329-97de8b5b4407 37000-312 HUMAN OTC DRUG Secret Fresh Effects Invisible Refreshing Nectarine Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20130115 20160605 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g 37000-313_fc9013f0-f347-4329-ba71-03d0f77e0db1 37000-313 HUMAN OTC DRUG Olay Age Defying Sensitive Skin Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL 37000-314_254a2699-b47d-46cb-80d0-001cf31a66a4 37000-314 HUMAN OTC DRUG Olay Fresh Effects BB Broad Spectrum SPF 15 Fair to Light Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/mL; g/mL; g/mL; g/mL 37000-315_2db8fd35-9550-4363-b300-18699a1c8c08 37000-315 HUMAN OTC DRUG Olay Fresh Effects Acne Face Wash Salicylic Acid LIQUID TOPICAL 20140312 OTC MONOGRAPH FINAL part333D Procter & Gamble Manufacturing Company SALICYLIC ACID 2 g/100mL 37000-316_772a8b98-982d-40ed-a8e8-4805b3f19340 37000-316 HUMAN OTC DRUG Olay Fresh Effects Acne Control Scrub Salicylic Acid LIQUID TOPICAL 20140312 OTC MONOGRAPH FINAL part333D Procter & Gamble Manufacturing Company SALICYLIC ACID 2 g/100mL 37000-317_f5af77ea-a8d8-4dc6-9e89-c22dde2d9a3f 37000-317 HUMAN OTC DRUG Olay Total Effects Blemish Control Acne Cleanser Salicylic Acid LIQUID TOPICAL 20140115 OTC MONOGRAPH FINAL part333D Procter & Gamble Manufacturing Company SALICYLIC ACID 2 g/100mL 37000-318_65f4ad2b-aea3-4456-993b-709dead1f14f 37000-318 HUMAN OTC DRUG Olay Total Effects Pore Minimizing CC Broadspectrum SPF 15 Fair to Light Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company HOMOSALATE; OCTISALATE; OCTOCRYLENE 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL 37000-319_93da35c0-9175-4ea3-8a04-b56fc1b76414 37000-319 HUMAN OTC DRUG Olay Total Effects Pore Minimizing CC Broadspectrum SPF 15 Light to Medium Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company HOMOSALATE; OCTISALATE; OCTOCRYLENE 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL 37000-320_5ddb31f6-3ecb-454f-86eb-d4b534919ac1 37000-320 HUMAN OTC DRUG Olay Total Effects Pore Minimizing CC Broadspectrum SPF 15 Medium to Deep Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company HOMOSALATE; OCTISALATE; OCTOCRYLENE 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL 37000-322_9ed6a00f-3b6e-471d-905f-721ef83cf92a 37000-322 HUMAN OTC DRUG Head and Shoulders 2in1 Dry Scalp Care Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20051201 20151221 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/mL 37000-323_47c26584-fac8-4213-ae30-c25523957c76 37000-323 HUMAN OTC DRUG Head and Shoulders 2in1 Ocean Lift Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20051201 20151205 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/mL 37000-324_33c1609c-40ae-4e4b-bed1-c4b04afb7e74 37000-324 HUMAN OTC DRUG Head and Shoulders 2in1 Smooth and Silky Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20051201 20151205 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/mL 37000-327_3aedaf80-c1c9-4745-bda3-e9ccbb6e7adb 37000-327 HUMAN OTC DRUG Head and Shoulders 2in1 Refresh Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20051201 20151205 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/mL 37000-328_2f704769-df5b-451b-800a-5fdad2d1dd13 37000-328 HUMAN OTC DRUG Head and Shoulders 2in1 Citrus Breeze Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20051201 20151216 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/mL 37000-329_84b1a768-94bf-4d24-8ebc-da82fd51e357 37000-329 HUMAN OTC DRUG Head and Shoulders 2in1 Hair Endurance for Men Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20051201 20160916 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/mL 37000-330_5ae55c1d-16a9-40bc-983d-3f888c757da7 37000-330 HUMAN OTC DRUG Head and Shoulders Clinical Strength Selenium Sulfide LOTION/SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. SELENIUM SULFIDE 1 g/100mL 37000-331_f48ef44a-e7d8-45aa-adcc-100d83293c66 37000-331 HUMAN OTC DRUG Head and Shoulders Itchy Scalp Care Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20110101 20151115 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/mL 37000-332_e3841a5d-5008-4164-823e-a75065a492e1 37000-332 HUMAN OTC DRUG Head and Shoulders 2in1 Itchy Scalp Care Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20110101 20151026 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/mL 37000-335_acdf3bf9-2892-4f8c-bbe6-eb3d4b3f192a 37000-335 HUMAN OTC DRUG Head and Shoulders Men Deep Clean Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20120101 20150813 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC .01 g/mL 37000-336_2d7e5929-3045-4777-b128-ad65b5836623 37000-336 HUMAN OTC DRUG Head and Shoulders Men Deep Clean 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20120101 20151009 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC .01 g/mL 37000-337_b5d25f2d-2a4a-4c02-9fc6-1febb4ea09a0 37000-337 HUMAN OTC DRUG Head and Shoulders Active Sport Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20120101 20151121 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC .01 g/mL 37000-338_dd498faf-ae3e-45c2-9a15-4cc2bb599006 37000-338 HUMAN OTC DRUG Head and Shoulders Active Sport 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20120101 20151204 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC .01 g/mL 37000-339_f0f88438-0279-4da8-bbf1-4d462a29ef8d 37000-339 HUMAN OTC DRUG Head and Shoulders 2in1 Refresh Men Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20120101 20151031 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC .01 g/mL 37000-340_fcfefaeb-8772-438d-a9ff-28fdc42e0a1f 37000-340 HUMAN OTC DRUG Head and Shoulders Refresh Men Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20120101 20150801 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC .01 g/mL 37000-341_c51a5ba2-44d7-40ec-aa2d-703a8f138097 37000-341 HUMAN OTC DRUG Head and Shoulders Instant Relief Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-342_33f3baf0-754e-4e08-b21d-4719e1f66147 37000-342 HUMAN OTC DRUG Head and Shoulders 2in1 Instant Relief Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-343_ec850a0d-fc0b-4bc7-ac06-262c6f213774 37000-343 HUMAN OTC DRUG Head and Shoulders Conditioner Instant Relief Pyrithione Zinc LOTION TOPICAL 20140901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC .5 g/100mL 37000-344_1cdafdbb-ceca-40e9-bbbe-ea09c238c433 37000-344 HUMAN OTC DRUG Head and Shoulders Instant Oil Control Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-345_b9d4e4e9-e790-4f16-9d7a-2b6751c00e38 37000-345 HUMAN OTC DRUG Head and Shoulders 2in1 Instant Oil Control Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-346_9a2a84b8-8b08-487e-945f-f98d534d92b5 37000-346 HUMAN OTC DRUG Head and Shoulders Instant Oil Control Conditioner Pyrithione Zinc LOTION TOPICAL 20140901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC .5 mg/100mL 37000-347_654178cb-8532-4e32-8d00-8a0373320c62 37000-347 HUMAN OTC DRUG Head and Shoulders Instant Hydration Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-348_0a381955-02e1-4208-934e-7710177b7980 37000-348 HUMAN OTC DRUG Head and Shoulders Instant Hydration 2 in 1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/mL 37000-349_48a31abe-814c-4f25-acba-f1db8c4811f6 37000-349 HUMAN OTC DRUG Head and Shoulders Conditioner Instant Hydration Pyrithione Zinc LOTION TOPICAL 20140901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC .5 g/100mL 37000-350_bae95940-82c2-4abd-8bce-6bf56a56e743 37000-350 HUMAN OTC DRUG Head and Shoulders Extra Strength Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140910 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 2 g/100mL 37000-351_8acf9632-2b75-4551-9e68-9335321e72a1 37000-351 HUMAN OTC DRUG Olay Complete All Day Moisturizer with Sunscreen Broad Spectrum SPF 30 Sensitive Octinoxate, Octisalate, Octocrylene, and Zinc Oxide LOTION TOPICAL 20140821 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 7.5; 2.5; 2.5; 7 g/100mL; g/100mL; g/100mL; g/100mL 37000-352_518c2a03-49de-460b-8749-4dbc1e08963c 37000-352 HUMAN OTC DRUG Olay Total Effects Anti-Aging Moisturizer Broad Spectrum SPF 15 Fragrance Free Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL 37000-353_d7fb335e-a28b-4519-a366-f33d912b3ce3 37000-353 HUMAN OTC DRUG Olay Total Effects CC Tone Correcting Broad Spectrum SPF 15 Fair to Light Avobenzone, Octisalate, and Octocrylene CREAM TOPICAL 20131103 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 3; 3 g/mL; g/mL; g/mL 37000-354_fe6b1e46-c566-4705-9429-fc4aa98f2b03 37000-354 HUMAN OTC DRUG Old Spice Red Zone Sweat Defense Swagger Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20091201 20161101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g 37000-355_974b312e-262b-4027-a8b5-fcda1deec031 37000-355 HUMAN OTC DRUG Olay Total Effects CC Tone Correcting Broad Spectrum SPF 15 Light to Medium Avobenzone, Octisalate, and Octocrylene CREAM TOPICAL 20131107 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 3; 3 g/mL; g/mL; g/mL 37000-356_c2134af7-8ea4-42c0-bccc-ff666ed52c4e 37000-356 HUMAN OTC DRUG Olay Total Effects Anti-Aging Moisturizer Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 26; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 37000-357_6b931278-3008-4171-a064-966dfcbca22d 37000-357 HUMAN OTC DRUG Olay Regenerist Luminous Brightening and Protecting Moisturizer Broadspectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL 37000-358_4a216125-8c1a-46dc-8a97-02cc9b930f78 37000-358 HUMAN OTC DRUG Olay Total Effects CC Tone Correcting Broad Spectrum SPF 15 Medium to Deep Avobenzone, Octisalate, and Octocrylene CREAM TOPICAL 20131110 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 3; 3 g/mL; g/mL; g/mL 37000-360_9c88ddf1-72c2-4fb4-b43f-e4c1087b4993 37000-360 HUMAN OTC DRUG Secret Clinical Advanced Sport Fresh Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20140107 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g 37000-361_4de47e68-bfcb-40ff-be46-76bdf339d7ee 37000-361 HUMAN OTC DRUG Secret Clinical Clear Sport Fresh Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20140130 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .2 g/g 37000-362_0cbdac15-55a3-4fc0-8154-4563e4b4111b 37000-362 HUMAN OTC DRUG Secret Clinical Clear Ooh La La Lavender Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20131101 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .2 g/g 37000-363_d1b26d1a-2803-4cee-a8d2-945a8b6a6933 37000-363 HUMAN OTC DRUG Secret Clinical Clear Completely Clean Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20131101 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .2 g/g 37000-364_e14390dd-c2d5-4c5b-b1d2-4783eb192f1b 37000-364 HUMAN OTC DRUG Secret Clinical Clear Powder Protection Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20131101 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .2 g/g 37000-365_9b52e631-588b-4212-9a8a-2df85c02b03b 37000-365 HUMAN OTC DRUG Secret Clinical Invisible Ooh La La Lavender Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20131122 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/g 37000-366_cb326e95-12cf-47e7-b3e0-aca07150c24b 37000-366 HUMAN OTC DRUG Secret Clinical Invisible Completely Clean Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20131122 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/g 37000-367_825169ac-90f5-423c-abbc-82374b0b35d5 37000-367 HUMAN OTC DRUG Secret Clinical Invisible Powder Protection Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20131122 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/g 37000-368_6115e0ff-a9f3-4e7e-a312-139afbc5684a 37000-368 HUMAN OTC DRUG Secret Clinical Invisible Sport Fresh Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20131122 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/g 37000-369_cdbdf45c-db1d-409b-8eaa-af12af56e64e 37000-369 HUMAN OTC DRUG Secret Outlast Invisible Sport Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g 37000-370_091fade0-9e40-4078-9224-77d3dba066ff 37000-370 HUMAN OTC DRUG Secret Outlast Invisible Unscented ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g 37000-371_2f8cde8f-e46f-4137-8a68-b240b32d2e16 37000-371 HUMAN OTC DRUG Secret Outlast Invisible Completely Clean ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g 37000-372_63d6d466-cd9e-4d22-b667-8d8aeaf8a3b4 37000-372 HUMAN OTC DRUG Secret Outlast Clear Sport Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY GEL TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .16 g/g 37000-373_fc835dce-a88b-4203-bf19-0afc7b0702d7 37000-373 HUMAN OTC DRUG Secret Outlast Clear Unscented ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY GEL TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .16 g/g 37000-375_6e016621-9b31-4a33-b76a-2a0c27c631b6 37000-375 HUMAN OTC DRUG Secret Outlast Clear Completely Clean ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY GEL TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .16 g/g 37000-378_76708f95-027b-46af-b71c-0e2c9a9b12b1 37000-378 HUMAN OTC DRUG Old Spice Aqua Reef Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20031113 20160110 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .17 g/g 37000-379_4e3f2257-2da3-4c35-8305-f690ed20e26f 37000-379 HUMAN OTC DRUG Old Spice Pure Sport Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20031113 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .178 g/g 37000-380_40429a8a-ad96-43e0-bb6a-ed94ff8151bf 37000-380 HUMAN OTC DRUG Head and Shoulders Moisture Care Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL 37000-381_ee7dda89-8da5-4203-a425-a1a714f640be 37000-381 HUMAN OTC DRUG Head and Shoulders 2in1 Moisture Care Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/mL 37000-382_7d7d6c34-270a-4464-874c-c71698421a09 37000-382 HUMAN OTC DRUG Head and Shoulders Moisture Care Cowash Pyrithione Zinc LOTION TOPICAL 20140901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC .5 g/100mL 37000-383_4f2131f9-91da-4b80-8ed0-9e611119453b 37000-383 HUMAN OTC DRUG Old Spice High Endurance Long Lasting Stick Playmaker Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20110101 20151215 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .17 g/g 37000-384_cd7d8372-584c-41a5-82be-728048b2539b 37000-384 HUMAN OTC DRUG Secret Outlast Clear Protecting Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g 37000-385_499f4f1c-9b9f-44b8-b191-010fa06852d6 37000-385 HUMAN OTC DRUG Old Spice After Hours ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20050401 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .17 g/g 37000-386_447f367b-81e4-479e-8592-d7deb38b13fd 37000-386 HUMAN OTC DRUG Old Spice Red Zone Collection Danger Zone Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120101 20150430 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .17 g/g 37000-388_3a9473cc-3489-457c-97d7-5292313b67cc 37000-388 HUMAN OTC DRUG Old Spice Red Zone Invisible Solid Champion Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120501 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .17 g/g 37000-389_64ae4c90-45fa-4883-8373-40853f22d2ee 37000-389 HUMAN OTC DRUG Old Spice Sweat Defense Champion Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120501 20161101 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g 37000-392_3ce6563c-7747-4ed3-916a-7b1dfbd7207c 37000-392 HUMAN OTC DRUG Dolce and Gabbana The Primer Sheer Radiance Make Up Base with Sunscreen Broad Spectrum SPF 30 Ensulizole, Octinoxate, and Zinc Oxide LOTION TOPICAL 20140424 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company ENSULIZOLE; OCTINOXATE; ZINC OXIDE 1; 7.49; 3.92 g/100mL; g/100mL; g/100mL 37000-394_76d91dc9-28c3-4bb1-8b85-deb72446195f 37000-394 HUMAN OTC DRUG Old Spice High Endurance Smooth Blast Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120501 20150410 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .17 g/g 37000-395_0e57ba40-414b-4cc6-b4ab-3876f9c27e5a 37000-395 HUMAN OTC DRUG Dolce and Gabbana Daily Moisturizer Broad Spectrum SPF 15 Octinoxate and Zinc Oxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; ZINC OXIDE 6; 3 g/100mL; g/100mL 37000-396_a230c29f-fa2f-42af-8939-a7e5bdcbea62 37000-396 HUMAN OTC DRUG Old Spice Red Zone Collection Swagger aluminum zirconium trichlorohydrex gly STICK TOPICAL 20080501 20161101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .17 g/g 37000-397_007e9d33-b538-4197-8435-b7cea5f19499 37000-397 HUMAN OTC DRUG Old Spice Red Zone Collection Swagger ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY STICK TOPICAL 20051201 20160801 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .16 g/g 37000-398_08814df8-07cc-4388-94c0-d4e5bbc89c5a 37000-398 HUMAN OTC DRUG Dolce and Gabbana Perfect Luminous Foundation Broadspectrum SPF 15 (All shades) Octinoxate and Titanium Dioxide LIQUID TOPICAL 20130121 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 40; 40 mg/mL; mg/mL 37000-402_93b19c55-ea47-485e-a899-07c2a58bd651 37000-402 HUMAN OTC DRUG Pepto-Bismol Bismuth Subsalicylate KIT 20110912 OTC MONOGRAPH FINAL part335 Procter & Gamble Manufacturing Company 37000-403_c97a238c-5c55-4dea-a054-ff7b8f4a5460 37000-403 HUMAN OTC DRUG Pepto-Bismol Bismuth Subsalicylate KIT 20120305 OTC MONOGRAPH FINAL part335 Procter & Gamble Manufacturing Company 37000-404_c387feb0-c572-4c6c-9cfc-265cb8776cee 37000-404 HUMAN OTC DRUG Vicks QlearQuil All Day And All Night 24 Hour Allergy Relief Loratadine TABLET ORAL 20140301 ANDA ANDA076301 The Procter & Gamble Manufacturing Company LORATADINE 10 mg/1 37000-406_a40dd390-e568-4518-80be-66bc4d27ba10 37000-406 HUMAN OTC DRUG Vicks QlearQuil Nighttime Allergy Relief Diphenhydramine Hydrochloride TABLET ORAL 20140301 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 37000-407_f62ed7bd-1a25-4c83-bb8c-dc9f747befe7 37000-407 HUMAN OTC DRUG Vicks QlearQuil Daytime Sinus and Congestion Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140301 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 37000-408_0c3f3279-e6fa-4be7-b11e-95f5db04fbd3 37000-408 HUMAN OTC DRUG Vicks QlearQuil Nighttime Sinus and Congestion Acetaminophen, Doxylamine succinate, and Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20140301 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 37000-409_131339ec-d346-4af3-bc37-f5b0ea497c52 37000-409 HUMAN OTC DRUG Vicks QlearQuil Daytime Sinus and Congestion and Nighttime Sinus and Congestion Acetaminophen, Phenylephrine Hydrochloride, and Doxylamine Succinate KIT 20140721 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company 37000-409_588e4b23-3a45-4352-9676-59cc0f164006 37000-409 HUMAN OTC DRUG Vicks QlearQuil Daytime Sinus and Congestion and Nighttime Sinus and Congestion Acetaminophen, Phenylephrine Hydrochloride, and Doxylamine Succinate KIT 20140721 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company 37000-410_2d3135ca-0661-4706-815b-18948b3f39de 37000-410 HUMAN OTC DRUG Vicks QlearQuil 12 Hour Decongestant Moisturizing Oxymetazoline Hydrochloride SPRAY NASAL 20140301 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company OXYMETAZOLINE HYDROCHLORIDE .512 mg/mL 37000-412_5e392c15-8d06-43dd-8624-07f14e21f40d 37000-412 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Cold and Flu Multi-Symptom Relief/Cold and Flu Nighttime Relief Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, and Doxylamine Succinate KIT 20140321 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company 37000-413_5e392c15-8d06-43dd-8624-07f14e21f40d 37000-413 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Cold and Flu Multi-Symptom Relief/Cold and Flu Nighttime Relief Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, Acetaminophen, Doxylamine Succinate, and Dextromethorphan Hydrobromide KIT 20140321 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company 37000-414_5e392c15-8d06-43dd-8624-07f14e21f40d 37000-414 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Cold and Flu Multi-Symptom Relief/Cold and Flu Nighttime Relief Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, Acetaminophen, Doxylamine Succinate, and Dextromethorphan Hydrobromide KIT 20140321 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company 37000-415_2dd8fc6e-6267-4711-ac3a-dbf62a75dcf6 37000-415 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Severe Cold and Flu Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, Doxylamine Succinate and Guaifenesin KIT 20140721 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company 37000-416_2dd8fc6e-6267-4711-ac3a-dbf62a75dcf6 37000-416 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Severe Cold and Flu Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, Doxylamine Succinate and Guaifenesin KIT 20140721 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company 37000-417_2dd8fc6e-6267-4711-ac3a-dbf62a75dcf6 37000-417 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Severe Cold and Flu Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, Doxylamine Succinate and Guaifenesin KIT 20140721 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company 37000-451_b88f118a-b1cd-4c6c-9d8a-fbf2c2a93115 37000-451 HUMAN OTC DRUG Crest Pro-Health Multi-Protection Refreshing Clean Mint Cetylpyridinium chloride RINSE ORAL 20110203 OTC MONOGRAPH NOT FINAL part356 Procter & Gamble Manufacturing Company CETYLPYRIDINIUM CHLORIDE .014 g/20mL 37000-452_a2499650-dfae-47f8-81be-99f14e495405 37000-452 HUMAN OTC DRUG Crest Pro-Health Cetylpyridinium chloride RINSE ORAL 20110314 OTC MONOGRAPH NOT FINAL part356 Procter & Gamble Manufacturing Company CETYLPYRIDINIUM CHLORIDE .014 g/mL 37000-453_768c3a0b-c118-4e8e-918a-a5b07469b49c 37000-453 HUMAN OTC DRUG Metamucil Therapy for Regularity Psyllium Husk POWDER ORAL 19980717 20160811 OTC MONOGRAPH NOT FINAL part334 The Procter & Gamble Manufacturing Company PSYLLIUM HUSK 3.4 g/7g 37000-454_b12a020e-941b-4b25-aaa8-177ca18a90ec 37000-454 HUMAN OTC DRUG Metamucil Therapy for Regularity PSYLLIUM HUSK POWDER ORAL 19980717 20160811 OTC MONOGRAPH NOT FINAL part334 The Procter & Gamble Manufacturing Company PSYLLIUM HUSK 3.4 g/5.4g 37000-455_ff6f97ec-88fc-4d07-9d00-e3ab64aa27f4 37000-455 HUMAN OTC DRUG Prilosec OTC omeprazole magnesium TABLET, DELAYED RELEASE ORAL 20030714 NDA NDA021229 Procter & Gamble Manufacturing Company OMEPRAZOLE MAGNESIUM 20.6 mg/1 37000-459_a52cb08d-0476-4580-a4de-04e4a1a94fb8 37000-459 HUMAN OTC DRUG Prilosec OTC OMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE ORAL 20120815 NDA NDA021229 Procter & Gamble Manufacturing Company OMEPRAZOLE MAGNESIUM 20.6 mg/1 37000-470_a2362e9d-a366-4a7c-b671-c7fc09853dc5 37000-470 HUMAN OTC DRUG Crest Anti-Cavity Regular SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20080801 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-474_d8224253-689b-4523-a5cd-f1b907700a95 37000-474 HUMAN OTC DRUG Kids Crest Spiderman Sodium fluoride GEL, DENTIFRICE DENTAL 20041217 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-475_028076b9-c732-4707-8352-932e148b3bf3 37000-475 HUMAN OTC DRUG Pepto-Bismol Bismuth subsalicylate LIQUID ORAL 20040630 OTC MONOGRAPH FINAL part335 Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 525 mg/30mL 37000-476_fe634f08-bf6b-4521-b6bf-6af53a68885f 37000-476 HUMAN OTC DRUG Pepto-Bismol Bismuth subsalicylate TABLET ORAL 20040630 OTC MONOGRAPH FINAL part335 Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 262 mg/1 37000-477_1eedfb31-fe67-4046-a64e-c4517ade0f60 37000-477 HUMAN OTC DRUG Pepto-Bismol Bismuth subsalicylate TABLET ORAL 20040630 OTC MONOGRAPH FINAL part335 Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 262 mg/1 37000-490_222073e9-e3e4-4a66-9967-cfb2637708d1 37000-490 HUMAN OTC DRUG Childrens Pepto Calcium Carbonate TABLET, CHEWABLE ORAL 20050720 OTC MONOGRAPH FINAL part331 Procter & Gamble Manufacturing Company CALCIUM CARBONATE 400 mg/1 37000-500_4632d99f-f3be-4412-b702-1035d239e4fe 37000-500 HUMAN OTC DRUG ZzzQuil Nighttime Sleep-Aid DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20111208 OTC MONOGRAPH FINAL part338 Procter & Gamble Manufacruing Company DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 37000-501_24f3c7ee-9636-4681-a5cd-4f270f403838 37000-501 HUMAN OTC DRUG ZzzQuil Nighttime Sleep-Aid Diphenhydramine Hydrochloride CAPSULE, GELATIN COATED ORAL 20111208 OTC MONOGRAPH FINAL part338 Procter & Gamble Manufacturing Company DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/21 37000-502_5488d338-7979-46f2-895b-efab2411dafe 37000-502 HUMAN OTC DRUG Vicks NyQuil Cold and Flu Nighttime Relief and Vicks Childrens NyQuil Cold and Cough Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate, and Chlorpheniramine maleate KIT 20120723 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company 37000-512_a5d2cc9d-10f7-4b00-b85c-957bf3c7fbf1 37000-512 HUMAN OTC DRUG Crest Sensitivity Clinical Sensitivity Relief Potassium nitrate and Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100830 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company POTASSIUM NITRATE; SODIUM FLUORIDE .05; 243 g/g; g/g 37000-519_77188cb2-71ad-4d73-a74b-6fd12ee3c539 37000-519 HUMAN OTC DRUG Crest Sensitivity Clinical Sensitivity Relief Potassium nitrate and Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100830 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company POTASSIUM NITRATE; SODIUM FLUORIDE .05; 243 g/g; g/g 37000-522_0708a2d6-5a9f-4e26-b552-748c67c20c8d 37000-522 HUMAN OTC DRUG Vicks VapoSteam camphor (synthetic) LIQUID RESPIRATORY (INHALATION) 19950228 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company CAMPHOR (SYNTHETIC) .062 g/mL 37000-544_6fea4ad1-fc84-4965-8d90-9fdb69959260 37000-544 HUMAN OTC DRUG Vicks VapoRub Camphor (synthetic), Eucalyptus oil, and Menthol OINTMENT TOPICAL 19930730 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL .048; .012; .026 g/g; g/g; g/g 37000-550_501fc3f5-91be-4a6d-ae77-5b542d869078 37000-550 HUMAN OTC DRUG Vicks NyQuil Cough Dextromethorphan Hydrobromide and Doxylamine succinate LIQUID ORAL 20110622 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 37000-555_89c7d25a-02dd-4f6e-85e1-63cbdcd7722c 37000-555 HUMAN OTC DRUG Vicks DayQuil Cold and Flu Multi-Symptom Relief Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride LIQUID ORAL 20110622 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 37000-556_899b7907-7a0b-41da-b45b-1ce2f7773d2b 37000-556 HUMAN OTC DRUG Vicks Childrens NyQuil Cold and Cough Multi-Symptom Relief Chlorpheniramine maleate and Dextromethorphan Hydrobromide SOLUTION ORAL 20110622 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 2; 15 mg/15mL; mg/15mL 37000-557_9d76bb2b-850d-483f-8eaa-9c789717f48a 37000-557 HUMAN OTC DRUG Vicks NyQuil Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20110609 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 37000-558_ece3d95d-41d3-4cc7-b23d-29749657a8d3 37000-558 HUMAN OTC DRUG Vicks DayQuil Cold and Flu Multi-Symptom Relief Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20110609 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 37000-561_ff5d8940-6b1d-4a83-8071-32d254b2d844 37000-561 HUMAN OTC DRUG Crest Pro-Health Clinical Gum Protection Stannous Fluoride PASTE, DENTIFRICE DENTAL 20100830 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 454 mg/g 37000-565_849d4e90-032d-4b0c-8dea-ac7da3441bac 37000-565 HUMAN OTC DRUG Vicks DayQuil Cough Dextromethorphan Hydrobromide LIQUID ORAL 20110622 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company DEXTROMETHORPHAN HYDROBROMIDE 15 mg/15mL 37000-587_e0810d21-780e-4636-bfec-50fbf379d56f 37000-587 HUMAN OTC DRUG Metamucil Therapy for Regularity PSYLLIUM HUSK POWDER ORAL 19980717 20160811 OTC MONOGRAPH NOT FINAL part334 The Procter & Gamble Manufacturing Company PSYLLIUM HUSK 3.4 g/5.8g 37000-590_ca5cd26e-6dc2-41fb-9e6b-bb9f6644a4b3 37000-590 HUMAN OTC DRUG Crest Wild Expressions Burstin Bubblegum Sodium fluoride GEL, DENTIFRICE TOPICAL 20061215 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-600_18550305-a825-4638-abe6-04d711ab217e 37000-600 HUMAN OTC DRUG Safeguard Triclosan SOAP TOPICAL 20011001 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company TRICLOSAN .25 g/100mL 37000-601_a9561dea-9ac2-439d-8866-76df76e93c6f 37000-601 HUMAN OTC DRUG Safeguard Antibacterial Foaming Benzalkonium Chloride SOAP TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company BENZALKONIUM CHLORIDE .12 g/100mL 37000-602_387aeb02-b64e-447a-967a-3e56d4d08868 37000-602 HUMAN OTC DRUG Safeguard Antibacterial E2 Foaming Benzalkonium Chloride SOAP TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company BENZALKONIUM CHLORIDE .12 g/100mL 37000-603_273266c6-4451-4c7b-9e3d-d99d3e2e8db3 37000-603 HUMAN OTC DRUG Safeguard Hand Sanitizer Alcohol GEL TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company ALCOHOL 64 g/100mL 37000-605_42f7347d-e86a-4ea9-b814-fb914598c25c 37000-605 HUMAN OTC DRUG Dawn Ultra Concentrated Apple Blossom Triclosan SOAP TOPICAL 20110201 20151019 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company TRICLOSAN .1 g/100mL 37000-606_2aba74a9-96bf-4a01-b1b5-45fc639e6065 37000-606 HUMAN OTC DRUG Dawn Ultra Concentrated Orange Triclosan SOAP TOPICAL 20110201 20151019 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company TRICLOSAN .1 g/100mL 37000-607_71e56d51-4d3c-4120-9e81-eb0013f99108 37000-607 HUMAN OTC DRUG Joy Ultra Orange Triclosan SOAP TOPICAL 20110201 20151019 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company TRICLOSAN .1 g/100mL 37000-609_013a25e6-4500-4e80-999d-85adfa5f5708 37000-609 HUMAN OTC DRUG Joy Non-ultra Triclosan SOAP TOPICAL 20110201 20151019 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company TRICLOSAN .1 g/100mL 37000-613_269dd5ae-c87d-45e3-9d41-236162f6af19 37000-613 HUMAN OTC DRUG Dawn Classic Triclosan SOAP TOPICAL 20110201 20151019 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company TRICLOSAN .1 g/100mL 37000-615_c3f63af3-e532-4b2c-b647-d7341dc9bceb 37000-615 HUMAN OTC DRUG Gain Ultra Lemon Zest Triclosan SOAP TOPICAL 20110201 20151019 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company TRICLOSAN .1 g/100mL 37000-616_775f2dea-d8cf-438f-b732-2f0b2c10c5fa 37000-616 HUMAN OTC DRUG Dawn Ultra Antibacterial Hand Apple Blossom Scent Chloroxylenol SOAP TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company CHLOROXYLENOL .3 g/100mL 37000-617_6caa3ca5-0c26-4836-8a8a-93c5800365a1 37000-617 HUMAN OTC DRUG Dawn Ultra Antibacterial Hand Orange Scent Chloroxylenol SOAP TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company CHLOROXYLENOL .3 g/100mL 37000-653_8b0e1b5a-cac7-4922-b299-fea3db5d0c12 37000-653 HUMAN OTC DRUG Pepto-Bismol Max Strength Bismuth subsalicylate LIQUID ORAL 20040630 OTC MONOGRAPH FINAL part335 Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 1050 mg/30mL 37000-654_5d4942af-481b-48d3-b696-b3a5e4005407 37000-654 HUMAN OTC DRUG Vicks NyQuil D Cold And Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate, and Pseudoephedrine Hydrochloride LIQUID ORAL 20120917 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1000; 30; 12.5; 60 mg/30mL; mg/30mL; mg/30mL; mg/30mL 37000-655_4a116ec8-d060-4fbb-9cf3-cb23c31ccac0 37000-655 HUMAN OTC DRUG Metamucil Therapy for Regularity Psyllium Husk POWDER ORAL 19980717 20160811 OTC MONOGRAPH NOT FINAL part334 Procter & Gamble Manufacturing Company PSYLLIUM HUSK 3.3 g/5.95g 37000-671_29bec7f0-110f-4f7b-9bbc-c44846ef2c61 37000-671 HUMAN OTC DRUG Vicks VapoRub Camphor (synthetic), Eucalyptus oil, and Menthol OINTMENT TOPICAL 19930730 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL .047; .012; .026 g/g; g/g; g/g 37000-673_080debcd-5799-46cd-888f-d62f01917e99 37000-673 HUMAN OTC DRUG Crest Pro-Health Stages Sodium Fluoride PASTE, DENTIFRICE DENTAL 20080801 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-674_48e3c528-cb04-44a9-83e4-33e8d7404509 37000-674 HUMAN OTC DRUG Crest Pro-Health Stages Sodium Fluoride PASTE, DENTIFRICE DENTAL 20080801 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-675_fc5c8456-ce05-4b44-94d0-bc5917ddaa12 37000-675 HUMAN OTC DRUG Crest Pro-Health Stages Sodium Fluoride PASTE, DENTIFRICE DENTAL 20080801 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-679_4affdbb1-3310-4513-8663-46da8339d85d 37000-679 HUMAN OTC DRUG Vicks VapoDrops Cough Relief Menthol LOZENGE ORAL 20090430 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company MENTHOL 1.7 mg/1 37000-680_722b50c4-0b1e-439a-950d-b899ec685eda 37000-680 HUMAN OTC DRUG Vicks VapoDrops Cough Relief Menthol LOZENGE ORAL 20090430 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company MENTHOL 3.3 mg/1 37000-686_3348c463-ade9-467c-b5b2-0bd911d52058 37000-686 HUMAN OTC DRUG Vicks VapoInhaler Levmetamfetamine INHALANT NASAL 20090709 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company LEVMETAMFETAMINE .245 mg/1000mg 37000-690_27c906cc-9d86-4df6-9b61-a7ee568b8c8f 37000-690 HUMAN OTC DRUG Vicks DayQuil Mucus Control DM Dextromethorphan Hydrobromide and Guaifenesin LIQUID ORAL 20090714 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/15mL; mg/15mL 37000-691_71e02852-31c4-4cc6-8e70-c4ceb55f3225 37000-691 HUMAN OTC DRUG Pepto-Bismol InstaCool Bismuth Subsalicylate TABLET, CHEWABLE ORAL 20090709 OTC MONOGRAPH FINAL part335 The Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 262 mg/1 37000-692_aadc08f8-4b39-46b8-bfe8-f0f86631441b 37000-692 HUMAN OTC DRUG Crest plus Scope and extra whitening Mint Splash Sodium Fluoride PASTE, DENTIFRICE DENTAL 20090908 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-693_74eab418-cc30-4ff4-bd36-086f2933967b 37000-693 HUMAN OTC DRUG Crest Extra White plus Scope Outlast Long Lasting Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20090908 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-695_246a0e81-8bcc-4a60-af89-325c843f6c68 37000-695 HUMAN OTC DRUG Crest 3D White Advanced Vivid Invigorating Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100315 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-696_bfdb2a5f-e9ea-422c-ab67-4ab0f4571888 37000-696 HUMAN OTC DRUG Crest 3D White Advanced Vivid Refreshing Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100315 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-697_b126b0d7-2d62-4e86-a4b5-a3c93e7b932b 37000-697 HUMAN OTC DRUG Crest Pro-Health Sensitive Shield Smooth Mint Stannous Fluoride GEL, DENTIFRICE DENTAL 20100315 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE .00454 mg/g 37000-698_7fc764c5-50eb-49e8-a82c-f75f882c05da 37000-698 HUMAN OTC DRUG Crest 3D White Vivid Radiant Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100315 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-699_69c6cc4b-9a1a-4671-b266-1e11dc892f1a 37000-699 HUMAN OTC DRUG Vicks Alcohol Free NyQuil Cold and Flu Nighttime Relief Acetaminophen, Chlorpheniramine maleate, and Dextromethorphan Hydrobromide LIQUID ORAL 20100601 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 325; 2; 15 mg/15mL; mg/15mL; mg/15mL 37000-699_743853c7-f8f3-452b-b801-b1c5bfb508b9 37000-699 HUMAN OTC DRUG Vicks Alcohol Free NyQuil Cold and Flu Nighttime Relief Acetaminophen, Chlorpheniramine maleate, and Dextromethorphan Hydrobromide LIQUID ORAL 20100601 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 325; 2; 15 mg/15mL; mg/15mL; mg/15mL 37000-700_c9c72580-16e4-44a0-9d08-4fb01852a607 37000-700 HUMAN OTC DRUG DDF Glycolic Exfoliating Salicylic Acid GEL TOPICAL 20120101 20161001 OTC MONOGRAPH FINAL part333D Procter & Gamble Manufacturing Company SALICYLIC ACID 2 g/100g 37000-701_60bec8ec-0315-4601-9dad-2cac650c5b8e 37000-701 HUMAN OTC DRUG DDF Sulfur Therapeutic Sulfur Acne Treatment sulfur PASTE TOPICAL 20130501 20161001 OTC MONOGRAPH FINAL part333D Procter & Gamble Manufacturing Company SULFUR 100 mg/g 37000-703_4ae7d23d-71e4-47d5-8ded-0448626766fb 37000-703 HUMAN OTC DRUG DDF Daily Protective Moisturizer Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20121101 20161001 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .03; .05; .05; .026 g/g; g/g; g/g; g/g 37000-704_a2bfb5a6-91c4-49b7-bc63-58b1f6e69db5 37000-704 HUMAN OTC DRUG DDF Ultra-Lite Moisturizing Dew Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20121101 20161001 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .03; .05; .05; .026 g/g; g/g; g/g; g/g 37000-705_348200c3-e5df-4c3d-83e8-04b31b3c7412 37000-705 HUMAN OTC DRUG DDF Mattifying Moisturizer Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20121101 20161001 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .03; .03; .05; .026 g/g; g/g; g/g; g/g 37000-706_ab455211-3df8-4e40-8576-2f0110e4b786 37000-706 HUMAN OTC DRUG DDF Advanced Moisture Defense Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20121101 20161001 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .03; .03; .05; .026 g/g; g/g; g/g; g/g 37000-708_139e7e3f-a8ce-4583-a1f7-8c1cd7144045 37000-708 HUMAN OTC DRUG DDF Benzoyl Peroxide Acne Treatment Benzoyl Peroxide GEL TOPICAL 20080501 20161001 OTC MONOGRAPH FINAL part333D Procter & Gamble Manufacturing Company BENZOYL PEROXIDE 50 mg/g 37000-709_e0a9006b-89c6-4f69-8991-f2c36b9afa10 37000-709 HUMAN OTC DRUG DDF Protective Eye Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20121101 20161001 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .03; .03; .05; .026 g/g; g/g; g/g; g/g 37000-711_7088e1d9-9b42-486b-84a0-79ee9c98cedc 37000-711 HUMAN OTC DRUG DDF Weightless Defense Hydrator Broad Spectrum SPF 45 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20121101 20161001 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .15; .05; .026; .06 g/g; g/g; g/g; g/g; g/g 37000-714_c0e1db6d-a6c6-46db-9b13-66d0a54cf501 37000-714 HUMAN OTC DRUG Safeguard Antibacterial Bar Beige Triclocarban SOAP TOPICAL 19630501 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company TRICLOCARBAN 1.356 g/113g 37000-715_a94a2787-c7ab-4ab2-bf4f-d9da87d39cc6 37000-715 HUMAN OTC DRUG Safeguard Antibacterial White with Aloe TRICLOCARBAN SOAP TOPICAL 19990201 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company TRICLOCARBAN 1.356 g/113g 37000-717_e4549f7d-2d81-45b4-9bf2-23a05342b0fe 37000-717 HUMAN OTC DRUG Secret Fresh Effects Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20090109 20160917 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g 37000-721_b3eee9a3-4ec5-4340-9927-f45fcdca3541 37000-721 HUMAN OTC DRUG DDF Acne Control Treatment Salicylic Acid LOTION TOPICAL 20090601 20161001 OTC MONOGRAPH FINAL part333D Procter & Gamble Manufacturing Co. SALICYLIC ACID .015 g/g 37000-724_cc82964f-594f-4bbc-b867-a45564bfcbc9 37000-724 HUMAN OTC DRUG DDF Blemish Foaming Cleanser Salicylic Acid LIQUID TOPICAL 20100201 OTC MONOGRAPH FINAL part333D Procter & Gamble Manufacturing Co. SALICYLIC ACID 17.64 mg/mL 37000-725_4ceb4357-190e-40ce-83a2-2b5ce7aad46b 37000-725 HUMAN OTC DRUG Secret Natural Mineral Unscented ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20110201 20150830 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .18 g/g 37000-726_f12a71af-3431-4796-b419-895f710dce9f 37000-726 HUMAN OTC DRUG Secret Natural Mineral Lemongrass Mint ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20110201 20160113 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .18 g/g 37000-727_95df41ae-cecf-48c3-907a-6915879b62bd 37000-727 HUMAN OTC DRUG Secret Natural Mineral Eucalyptus Blossom Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .18 g/g 37000-729_d058b426-9cec-4405-9f75-cabd0faa56ef 37000-729 HUMAN OTC DRUG DDF Protect and Correct UV Moisturizer Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20111219 20161001 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .03; .03; .05; .026 g/g; g/g; g/g; g/g 37000-732_2df3fa28-0548-4834-9189-852034f2f5e3 37000-732 HUMAN OTC DRUG Nioxin Scalp Recovery Moisturizing Condtioner Pyrithione Zinc LIQUID TOPICAL 20131201 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company PYRITHIONE ZINC 10 mg/mL 37000-733_d7be4b9a-36db-4336-a70b-5001b21daecb 37000-733 HUMAN OTC DRUG Nioxin Scalp Recovery Soothing Serum Pyrithione Zinc LIQUID TOPICAL 20110101 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company PYRITHIONE ZINC .97 mg/mL 37000-735_0e7383e0-99af-4713-ae3b-bd6ca1b8557e 37000-735 HUMAN OTC DRUG Zirh Defend Repairing SPF15 Moisturizer Octisalate, Avobenzone, Octocrylene, and Ensulizole LOTION TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE 19.6; 9.8; 39.2; 12.25 mg/mL; mg/mL; mg/mL; mg/mL 37000-739_70619895-3780-4573-901d-c9788bf4e491 37000-739 HUMAN OTC DRUG Nioxin Scalp Recovery Medicating Cleanser Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20110101 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 mg/mL 37000-744_8321326b-3ff2-48e9-9eba-01d72aa14e4b 37000-744 HUMAN OTC DRUG Old Spice Fresh Collection Belize Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120123 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g 37000-746_fe74d3c2-b356-4e1a-b371-23275925250a 37000-746 HUMAN OTC DRUG Old Spice Fresh Collection Matterhorn aluminum zirconium trichlorohydrex gly STICK TOPICAL 20100701 20161112 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g 37000-747_11232894-4b76-41b9-91ce-8e01bbeb4c77 37000-747 HUMAN OTC DRUG Old Spice Fresh Collection Denali aluminum zirconium trichlorohydrex gly STICK TOPICAL 20100701 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g 37000-749_af6ae7c4-654e-48a8-a762-80dde148b5d6 37000-749 HUMAN OTC DRUG Old Spice Fresh Collection Fiji Invisible aluminum zirconium trichlorohydrex gly STICK TOPICAL 20100701 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g 37000-751_efa0353a-3c14-4a9f-9a91-c9916ff3c824 37000-751 HUMAN OTC DRUG Secret Scent Expressions Invisible Solid Va Va Vanilla Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20081201 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g 37000-752_41498d25-84ff-421a-98e8-af8419e5e32b 37000-752 HUMAN OTC DRUG Olay Complete All Day Moisturizer Broad Spectrum SPF 15 Combination/Oily Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL 37000-754_c917aa7d-b394-4024-9df5-d3f14fa2db33 37000-754 HUMAN OTC DRUG Secret Scent Expressions Coco Butter Kiss Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20100405 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Co. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g 37000-755_e3ae0669-6427-4427-bcf0-b111b61d2933 37000-755 HUMAN OTC DRUG Secret Scent Expressions Invisible Solid Truth or Pear Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20081201 20151103 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g 37000-756_ae699c2f-4b3a-4ac4-97ee-d20f3d203f71 37000-756 HUMAN OTC DRUG Covergirl Smoothers Tinted Moisturizer BB Cream Broad Spectrum SPF 15 (all shades) Octinoxate and Zinc Oxide LIQUID TOPICAL 20121012 20151105 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; ZINC OXIDE 60; 30 mg/mL; mg/mL 37000-757_61965ab1-78bf-4b78-9ea2-1617b5f4e0e3 37000-757 HUMAN OTC DRUG Covergirl Smoothers Tinted Moisturizer BB Broad Spectrum SPF 21 (all shades) Octinoxate and Zinc Oxide LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; ZINC OXIDE 60; 30 mg/mL; mg/mL 37000-761_77d266d4-a5d8-4037-abe6-750f5fbfd824 37000-761 HUMAN OTC DRUG Secret Scent Expressions So Very Summerberry Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20100405 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Co. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g 37000-762_1ed8113d-87ab-4fc3-bbf2-907ad1ef4dd2 37000-762 HUMAN OTC DRUG Old Spice High Endurance Invisible Solid Game Day Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20091201 20151201 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .17 g/g 37000-763_a1860644-0a8e-489a-90ab-c80501c3caac 37000-763 HUMAN OTC DRUG Old Spice Sweat Defense After Hours Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20141015 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 37000-764_bcf5e150-7851-48fd-b56a-1cbb4aafb8ae 37000-764 HUMAN OTC DRUG Old Spice Red Zone Sweat Defense Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140201 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 37000-765_a5d45c05-30f5-4720-9879-116f060d043f 37000-765 HUMAN OTC DRUG Old Spice Red Zone Sweat Defense Pure Sport Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140201 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 37000-766_248c5e02-b924-49e8-83c9-47e39b0d87d5 37000-766 HUMAN OTC DRUG Old Spice Red Zone Sweat Defense Swagger Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140501 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 37000-767_47e61a56-f317-4871-bec4-6c0eccde1fbf 37000-767 HUMAN OTC DRUG Old Spice Red Zone Sweat Defense Champion Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140501 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 37000-769_cdfad0a5-db43-4216-a855-4026d0aac3e7 37000-769 HUMAN OTC DRUG Gillette Sport Undefeated Invisible Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20141220 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g 37000-771_15e49570-e218-4e68-9c9e-f4565e074477 37000-771 HUMAN OTC DRUG Gillette Mach 3 Invisible Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130130 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .17 g/g 37000-772_dd5e1fa3-77a5-48d3-af7e-a80031339654 37000-772 HUMAN OTC DRUG Gillette Mach 3 Invisible Clean Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130130 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .17 g/g 37000-775_0fe4f08d-1369-4773-bdfe-f6b899f2e5d2 37000-775 HUMAN OTC DRUG Gillette Clear Brisa Tropical Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20130130 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .16 g/g 37000-776_0088543e-eb12-427f-88f1-0da06c5229c4 37000-776 HUMAN OTC DRUG Gillette Odor Shield All Day Clean Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20100101 20160213 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g 37000-778_877a4296-116c-4f09-b41b-1d02cdf435cf 37000-778 HUMAN OTC DRUG Gillette Clinical Sport Advanced Training Day Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20131101 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .2 g/g 37000-780_db1eaa25-3a71-47a9-8f2e-2f4e9e1c9bef 37000-780 HUMAN OTC DRUG Gillette Clinical Odor Shield Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20100101 20160323 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .2 g/g 37000-781_e39f97b8-f3ac-4644-9f57-e4957a3e9ac4 37000-781 HUMAN OTC DRUG Head and Shoulders Dry Scalp Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20060101 20160224 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co PYRITHIONE ZINC 1 g/mL 37000-782_5d46839d-2217-4c14-96d6-020b421880fc 37000-782 HUMAN OTC DRUG Head and Shoulders Conditioner Dry Scalp Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20060101 20151214 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/mL 37000-783_853dd607-da82-4b9d-a577-6c677c381e73 37000-783 HUMAN OTC DRUG Head and Shoulders Conditioner Smooth and Silky Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20060101 20151210 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co PYRITHIONE ZINC 1 g/mL 37000-788_be4deab7-ed55-43a9-bbe9-43ed9af4bca9 37000-788 HUMAN OTC DRUG Head and Shoulders Ocean Lift Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20060101 20160119 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/mL 37000-789_bd6880f6-2733-47fc-b3f6-6643b520456a 37000-789 HUMAN OTC DRUG Head and Shoulders Smooth and Silky Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20060101 20160304 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/mL 37000-790_841e3757-c6b9-4ece-a29a-d13caf2f1705 37000-790 HUMAN OTC DRUG Head and Shoulders Citrus Breeze Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20060101 20151126 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/mL 37000-794_325830a1-8d80-4a6a-a94e-1733cf4fff5f 37000-794 HUMAN OTC DRUG Head and Shoulders Extra Volume Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20060101 20151125 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/mL 37000-795_971734a8-63b3-443d-961a-128470d73da5 37000-795 HUMAN OTC DRUG Head and Shoulders Hair Endurance For Men Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20091001 20150916 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/mL 37000-796_f8d86026-aca5-4b37-b5e9-f59ae814ec32 37000-796 HUMAN OTC DRUG Gucci Face Lustrous Glow Foundation Broadspectrum SPF 25 (all shades) Octinoxate and Titanium Dioxide LOTION TOPICAL 20140526 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 3.49; 2.52 g/100mL; g/100mL 37000-797_1cc1aedf-ad54-448e-98d7-84bb8ffc989d 37000-797 HUMAN OTC DRUG Head and Shoulders Conditioner Itchy Scalp Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20101001 20151212 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company PYRITHIONE ZINC .5 g/mL 37000-798_1cfa0dd8-b08a-4c25-a7bc-2bb0357f7b0b 37000-798 HUMAN OTC DRUG Pantene Pro-V Expert Collection Hair Regrowth Treatment for Women Minoxidil LIQUID TOPICAL 20131115 ANDA ANDA075357 Procter & Gamble Manufacturing Co. MINOXIDIL 20 mg/mL 37000-801_fdd96f50-42ef-4ca2-bad0-492d59e583c1 37000-801 HUMAN OTC DRUG Vicks Sinex 12 Hour Decongestant Ultra Fine Mist Moisturizing Oxymetazoline Hydrochloride SPRAY NASAL 20100706 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company OXYMETAZOLINE HYDROCHLORIDE .000512 g/mL 37000-802_3210a37a-b9c7-4b83-986c-09befb2ae00a 37000-802 HUMAN OTC DRUG Vicks Sinex 12 Hour Decongestant Ultra Fine Mist Oxymetazoline Hydrochloride SPRAY NASAL 20100706 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company OXYMETAZOLINE HYDROCHLORIDE .0005095 g/mL 37000-803_cf86a6da-5e82-4fb3-8a8f-b31a61baa88c 37000-803 HUMAN OTC DRUG Vicks Sinex 12 Hour Decongestant Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20100706 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company OXYMETAZOLINE HYDROCHLORIDE .0005055 g/mL 37000-807_334d4828-27fa-4e8a-96cd-283462b96896 37000-807 HUMAN OTC DRUG Vicks NyQuil Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate SOLUTION ORAL 20100601 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 37000-808_04bb3267-a9af-4a86-a48c-ae63d3b56299 37000-808 HUMAN OTC DRUG Vicks NyQuil Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate LIQUID ORAL 20100601 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 37000-809_f5dc3013-9e0e-4370-ae47-2a81761cf817 37000-809 HUMAN OTC DRUG Vicks NyQuil Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate LIQUID ORAL 20100601 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 37000-810_5b88f919-6ccf-43f5-8977-363e3e27965b 37000-810 HUMAN OTC DRUG Vicks DayQuil Severe Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride SOLUTION ORAL 20130722 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 37000-811_b70a122e-e1a0-42a6-9dfd-22e2c7fe4d97 37000-811 HUMAN OTC DRUG Vicks DayQuil Severe Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20130722 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 37000-812_0fc0918e-b7a0-4987-95ce-34ff337d354f 37000-812 HUMAN OTC DRUG Vicks NyQuil Severe Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride SOLUTION ORAL 20130722 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 37000-813_60610ca5-5099-4937-911d-2da0e154c531 37000-813 HUMAN OTC DRUG Vicks NyQuil Severe Cold and Flu Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, and Dextromethorphan Hydrobromide TABLET, COATED ORAL 20140721 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company [GO] ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 37000-814_318a3993-4b0f-49e5-a656-6c3b72587625 37000-814 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Severe Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, and doxylamine succinate KIT 20130722 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company 37000-815_79647c8f-a67e-4324-b60c-587e8ad7c9b3 37000-815 HUMAN OTC DRUG Vicks NyQuil Severe Cold and Flu Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, and Dextromethorphan Hydrobromide SOLUTION ORAL 20140721 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company [GO] ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/mL; mg/mL; mg/mL; mg/mL 37000-816_f6018149-71dc-460f-8ebd-a787def4cfb6 37000-816 HUMAN OTC DRUG Metamucil Therapy for Regularity Psyllium Husk KIT 19941215 20160811 OTC MONOGRAPH NOT FINAL part334 Procter & Gamble Manufacturing Company 37000-817_3f6c2b25-e7b3-4ae9-983d-aaa66c70361a 37000-817 HUMAN OTC DRUG Metamucil Therapy for Regularity Psyllium Husk KIT 19890331 20160811 OTC MONOGRAPH NOT FINAL part334 Procter & Gamble Manufacturing Company 37000-819_e2f2f5d0-a446-412c-abe7-eb7477886125 37000-819 HUMAN OTC DRUG Crest Complete Multi-Benefit Whitening plus Deep Clean Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-820_0204ed22-ccbf-41ab-8ac7-613abb61ac76 37000-820 HUMAN OTC DRUG Crest 3D White Advanced Vivid Enamel Renewal Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110301 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 243 g/g 37000-821_e9a9e783-4867-4e63-b438-7e471865eb60 37000-821 HUMAN OTC DRUG Kids Crest Sesame Street SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20101213 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.1 mg/g 37000-822_3422d4ad-57a3-4273-82ef-e44284e87429 37000-822 HUMAN OTC DRUG Crest Complete Multi-Benefit Plus Scope Sodium Fluoride GEL, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.1 mg/g 37000-823_49965ecb-94f3-480c-bec6-8bd66e7f0a40 37000-823 HUMAN OTC DRUG Crest Complete Multi-Benefit Tartar Control Whitening Plus Scope Sodium Fluoride GEL, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.1 mg/g 37000-824_a6608e2a-ad54-496d-b4f2-69e38b9d9175 37000-824 HUMAN OTC DRUG Crest Complete Multi-Benefit Whitening Plus Herbal Mint Expressions SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.1 mg/g 37000-825_07668ae3-238e-4544-a5c9-fedae22bd8fa 37000-825 HUMAN OTC DRUG Crest Complete Multi-Benefit Whitening Plus Herbal Mint Expressions SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.1 mg/g 37000-826_77ae639b-e1e6-43d3-84bd-e048d437bad0 37000-826 HUMAN OTC DRUG Crest Complete Multi-Benefit Whitening Plus Cinnamon Expressions Sodium Fluoride GEL, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.1 mg/g 37000-827_6c3c0675-06d0-48c5-80d6-3facade4b89b 37000-827 HUMAN OTC DRUG Crest Complete Multi-Benefit Whitening plus Cinnamon Expressions Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.1 mg/g 37000-828_fa162978-656f-40e8-90df-0deb566d071f 37000-828 HUMAN OTC DRUG Crest Complete Multi-benefit Tartar Control Whitening Plus Scope Sodium Fluoride GEL, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.1 mg/g 37000-829_22e3b66f-3806-48db-aad9-46a87a4b328a 37000-829 HUMAN OTC DRUG Crest Complete Multi-Benefit Extra Whitening with Tartar Protection Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-830_4989946a-8c20-4367-9d6c-6570f31854c1 37000-830 HUMAN OTC DRUG Crest Complete Multi-Benefit Extra White plus Scope dual blast fresh mint blast Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110801 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-831_ab34210c-956b-4204-b2d5-f1bf96c0ac26 37000-831 HUMAN OTC DRUG Crest 3D White Glamorous White Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120220 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-832_60217542-de9f-430e-941d-edab4fd779ac 37000-832 HUMAN OTC DRUG Crest 3D White Enamel Renewal Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120220 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-833_aeb377d6-0074-4386-99a5-96c0e092ba2c 37000-833 HUMAN OTC DRUG Kids Crest Cavity Protection Sodium Fluoride RINSE ORAL 20120723 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE .22 mg/mL 37000-834_83197e5c-dbef-45d3-81a9-80516d23c83a 37000-834 HUMAN OTC DRUG Crest Pro-Health For Me Sodium Fluoride RINSE ORAL 20120723 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE .22 mg/mL 37000-835_146da04e-2bb2-46b8-96a0-7ce39155bdab 37000-835 HUMAN OTC DRUG Crest Complete Multi-Benefit Extra White plus Crystal Clean anti bac Stannous Fluoride PASTE, DENTIFRICE DENTAL 20120806 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 4.54 mg/g 37000-836_a492a313-0508-43ce-8e47-60e271cd17d7 37000-836 HUMAN OTC DRUG Crest Pro-Health For Life Cetylpyridinium chloride RINSE ORAL 20120806 OTC MONOGRAPH NOT FINAL part356 Procter & Gamble Manufacturing Company CETYLPYRIDINIUM CHLORIDE .014 g/20mL 37000-837_2dbbaa5b-88bf-4c6b-9b72-c87f9bd612d3 37000-837 HUMAN OTC DRUG Crest 3D White Arctic Fresh Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120806 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g 37000-838_4957b713-9e2e-40ff-9982-aa29a5da8757 37000-838 HUMAN OTC DRUG Crest Pro-Health For Life Stannous Fluoride PASTE, DENTIFRICE DENTAL 20120820 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 4.54 mg/g 37000-839_bbc6b11b-3feb-4725-b027-90d01398e992 37000-839 HUMAN OTC DRUG Kids Crest Bubblegum Flavor Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110401 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g 37000-840_4f59eeab-84be-423d-a328-9e45bf1f08b2 37000-840 HUMAN OTC DRUG Kids Crest Grape Flavor Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110801 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.4 mg/g 37000-841_7f69d1d5-4c8d-448b-bc04-15ccb6f39dbf 37000-841 HUMAN OTC DRUG Crest Pro-Health Healthy Fresh Stannous Fluoride PASTE, DENTIFRICE DENTAL 20130201 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 4.54 mg/g 37000-842_c0b15692-1884-4553-aed6-f279631ddbdd 37000-842 HUMAN OTC DRUG Crest 3D White Luxe Lustrous Shine Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130901 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g 37000-843_d6f7bb19-cac5-46af-ae8a-1814e0e9bfd0 37000-843 HUMAN OTC DRUG Crest Pro-Health Clinical Cetylpyridinium chloride RINSE ORAL 20110220 OTC MONOGRAPH NOT FINAL part356 Procter & Gamble Manufacturing Company CETYLPYRIDINIUM CHLORIDE .02 g/20mL 37000-844_e3f55c6c-ac46-417f-9154-876d8c9fa746 37000-844 HUMAN OTC DRUG Crest 3D White Luxe Sodium Fluoride and Potassium Nitrate PASTE, DENTIFRICE DENTAL 20140204 OTC MONOGRAPH NOT FINAL part356 Procter & Gamble Manufacturing Company POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.4 mg/g; mg/g 37000-845_a0260d0c-a170-4b3d-9f18-461c26544d8f 37000-845 HUMAN OTC DRUG Crest Be Adventurous Sodium Fluoride PASTE, DENTIFRICE DENTAL 20140106 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g 37000-846_ac464ae7-8bc8-4659-86fb-9a439910fca9 37000-846 HUMAN OTC DRUG Crest Be Dynamic Sodium Fluoride PASTE, DENTIFRICE DENTAL 20140106 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g 37000-847_d9fcba77-ca5c-498a-b605-762b63a8e03b 37000-847 HUMAN OTC DRUG Crest Be Inspired Sodium Fluoride PASTE, DENTIFRICE DENTAL 20140106 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g 37000-848_4fb95b0e-69d0-4cff-830a-1654320c497e 37000-848 HUMAN OTC DRUG Crest Pro-Health Anticavity Fluoride Rinse Sodium Fluoride RINSE ORAL 20130708 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.2 mg/10mL 37000-849_8363a430-65c0-4781-8beb-5447064f6204 37000-849 HUMAN OTC DRUG Crest Sensi-Relief Sodium Fluoride and Potassium Nitrate PASTE, DENTIFRICE DENTAL 20140108 OTC MONOGRAPH NOT FINAL part356 Procter & Gamble Manufacturing Company POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.4 mg/g; mg/g 37000-850_7b43444e-0807-4f69-a49a-27178ecfbb92 37000-850 HUMAN OTC DRUG Crest Sensi-Relief Sodium Fluoride and Potassium Nitrate PASTE, DENTIFRICE DENTAL 20131113 OTC MONOGRAPH NOT FINAL part356 Procter & Gamble Manufacturing Company POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.4 mg/g; mg/g 37000-851_44180c91-e3a8-4a04-8dc4-f680cf2b3f21 37000-851 HUMAN OTC DRUG Crest 3D White Sodium Fluoride PASTE, DENTIFRICE DENTAL 20140204 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.4 mg/g 37000-852_60dab167-7fcd-4b0f-a0de-d213f6fd6b65 37000-852 HUMAN OTC DRUG Crest 3D White Sodium Fluoride PASTE, DENTIFRICE DENTAL 20140204 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g 37000-853_cf75f2c0-6e7a-452c-bbf7-d84ad326c063 37000-853 HUMAN OTC DRUG Crest 3D White Sodium Fluoride PASTE, DENTIFRICE DENTAL 20140204 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g 37000-854_eeb91c39-04e6-4feb-ac9f-df107711c2bc 37000-854 HUMAN OTC DRUG Crest Anticavity Fluoride Sodium Fluoride RINSE ORAL 20140417 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.2 mg/10mL 37000-855_abf1ceb4-7872-4787-8c98-f74240017dc8 37000-855 HUMAN OTC DRUG Crest 3D White Sodium Fluoride PASTE, DENTIFRICE DENTAL 20140701 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.6 mg/g 37000-856_42685934-8f61-4da2-a6e0-54cbf35e25fc 37000-856 HUMAN OTC DRUG Crest Pro-Health HD Stannous Fluoride KIT 20140315 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company 37000-857_f0f0469f-2e27-48a7-add4-c7f5a19a74e3 37000-857 HUMAN OTC DRUG Crest Sensi-Namel Sodium Fluoride and Potassium Nitrate PASTE, DENTIFRICE DENTAL 20140701 OTC MONOGRAPH NOT FINAL part356 The Procter & Gamble Manufacturing Company POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.4 mg/g; mg/g 37000-859_54847b6d-9f35-4d00-a775-599a1d7f8381 37000-859 HUMAN OTC DRUG Crest Pro-Health Intensive Clean Sodium Fluoride PASTE, DENTIFRICE DENTAL 20140701 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.6 mg/g 37000-900_14419c80-320a-428e-a2d2-d9ce6b7e4a8a 37000-900 HUMAN OTC DRUG Dolce and Gabbana The Lift Foundation Beige 78 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140405 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 29.9; 25.2 mg/mL; mg/mL 37000-901_3cabe2df-9e02-4bec-b335-5b0e1b16d29a 37000-901 HUMAN OTC DRUG Dolce and Gabbana The Lift Foundation Almond 150 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140405 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 29.9; 25.2 mg/mL; mg/mL 37000-902_8c8b4cd4-49de-4e16-9678-f0f5a770e574 37000-902 HUMAN OTC DRUG Dolce and Gabbana The Lift Foundation Amber 148 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140405 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 29.9; 25.2 mg/mL; mg/mL 37000-903_d60105fb-0063-4c8d-849e-3f068731ceb9 37000-903 HUMAN OTC DRUG Dolce and Gabbana The Lift Foundation Bisque 75 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140405 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 29.9; 25.2 mg/mL; mg/mL 37000-904_3836d2f3-9f1d-482f-9aac-2ca6c2a02c17 37000-904 HUMAN OTC DRUG Dolce and Gabbana The Lift Foundation Bronze 144 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140405 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 29.9; 25.2 mg/mL; mg/mL 37000-905_84790926-ef96-48e5-aa6d-afe54b5d556f 37000-905 HUMAN OTC DRUG Dolce and Gabbana The Lift Foundation Caramel 110 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140405 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 29.9; 25.2 mg/mL; mg/mL 37000-906_24b450c1-6275-4404-9173-06eec2b712b0 37000-906 HUMAN OTC DRUG Dolce and Gabbana The Lift Foundation Classic 60 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140405 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 29.9; 25.2 mg/mL; mg/mL 37000-907_e2f04198-d497-45f6-b070-f45928d07d97 37000-907 HUMAN OTC DRUG Dolce and Gabbana The Lift Foundation Creamy 80 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140405 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 29.9; 25.2 mg/mL; mg/mL 37000-908_b6bfce45-d220-45ef-8aa2-20623771cbb3 37000-908 HUMAN OTC DRUG Dolce and Gabbana The Lift Foundation Golden Honey 170 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140405 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 29.9; 25.2 mg/mL; mg/mL 37000-909_4ef50800-73f4-4462-845a-094517c4494d 37000-909 HUMAN OTC DRUG Dolce and Gabbana The Lift Foundation Natural Beige 120 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140405 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 29.9; 25.2 mg/mL; mg/mL 37000-910_ae9ff634-4a72-4b23-b69c-1c8d8a322e50 37000-910 HUMAN OTC DRUG Dolce and Gabbana The Lift Foundation Natural Glow 100 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140405 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 29.9; 25.2 mg/mL; mg/mL 37000-911_b6060dde-d4c0-452f-bc15-209adb2f453c 37000-911 HUMAN OTC DRUG Dolce and Gabbana The Lift Foundation Rose Beige 140 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140405 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 29.9; 25.2 mg/mL; mg/mL 37000-912_a3ad4d3a-94d0-4792-83dc-7dc2364f8f3f 37000-912 HUMAN OTC DRUG Dolce and Gabbana The Lift Foundation Soft Sable 180 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140405 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 29.9; 25.2 mg/mL; mg/mL 37000-913_246f862e-66ff-41b8-8200-fabfd318017e 37000-913 HUMAN OTC DRUG Dolce and Gabbana The Lift Foundation Soft Tan 160 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140405 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 29.9; 25.2 mg/mL; mg/mL 37000-914_33e52955-1dc5-4494-81fe-0879d95116e8 37000-914 HUMAN OTC DRUG Dolce and Gabbana The Lift Foundation Warm Rose 130 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140405 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 29.9; 25.2 mg/mL; mg/mL 37012-002_b979411d-4f44-4eed-9b3a-d973955befa6 37012-002 HUMAN OTC DRUG Shopko Athletes Foot Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Shopko Stores Operating Co., LLC CLOTRIMAZOLE 10 mg/g 37012-004_456fb25b-04f1-411f-8d0e-4e3db0286129 37012-004 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20110615 OTC MONOGRAPH FINAL part355 Shopko Stores Operating Co.LLC SODIUM FLUORIDE 10.4 mg/mL 37012-013_145444df-b2ed-4cc8-b35f-420160a1d9be 37012-013 HUMAN OTC DRUG Allergy Relief D Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20131002 ANDA ANDA076050 Shopko Stores Operating Co., LLC LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 37012-016_ad4fde13-4274-4a78-ab72-8a16543f5688 37012-016 HUMAN OTC DRUG Shopko Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Shopko Stores Operating Co., LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 37012-018_de30ed6d-e1ee-4c75-8a68-0ad992991039 37012-018 HUMAN OTC DRUG Shopko Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Shopko Stores Operating Co., LLC HYDROCORTISONE 1 g/100g 37012-026_8a864edf-5741-44a4-8615-e809ce986588 37012-026 HUMAN OTC DRUG Shopko Long Lasting Oil Free Moisturizer Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Shopko Stores Operating Co., LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 4; 3 mg/100mL; mg/100mL; mg/100mL; mg/100mL 37012-027_5abc93cf-759d-4df7-81f2-b550f57464ee 37012-027 HUMAN OTC DRUG Shopko Triple Antibiotic plus Pain Relief Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Shopko Stores Operating Co., LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g 37012-035_ca12b4f1-e74f-4feb-b099-302b2c66d2f5 37012-035 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 19970113 ANDA ANDA074444 Shopko Stores Operating Co., LLC MICONAZOLE NITRATE 2 mg/100g 37012-036_1ab4ceb0-cbc8-414a-a843-e81625122e0c 37012-036 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100723 ANDA ANDA090283 Shopko Stores Operating Co., LLC FAMOTIDINE 20 mg/1 37012-047_3dba55b3-3c9d-4a18-8c01-303107bf6c6d 37012-047 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20130605 ANDA ANDA078653 Shopko Stores Operating Co., LLC RANITIDINE HYDROCHLORIDE 150 mg/1 37012-054_f0f2f2b5-d015-499f-82e5-b11070fff9e2 37012-054 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140310 ANDA ANDA075153 Shopko Stores Operating Co., LLC PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 37012-056_481c6619-bec4-4c5c-99ff-ff145079b9d5 37012-056 HUMAN OTC DRUG night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140602 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 37012-059_1471ced7-154c-4d12-894c-a26fc84ce313 37012-059 HUMAN OTC DRUG Shopko Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Shopko Stores Operating Co., LLC HYDROCORTISONE 1 g/100g 37012-063_044f1876-e8a0-4a8a-92fb-200d64fb4abf 37012-063 HUMAN OTC DRUG Shopko Hydrocortisone Plus 12 Moisturizers Maximum Strength Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Shopko Stores Operating Co., LLC HYDROCORTISONE 1 g/100g 37012-065_0e97c2eb-7fad-460e-ae3f-ef4df16a1977 37012-065 HUMAN OTC DRUG Nasal Oxymetazoline HCl SPRAY NASAL 20130819 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 37012-069_d489c8e6-9c18-4214-bfe3-3c08aa617d91 37012-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 19901215 OTC MONOGRAPH FINAL part347 Shopko PETROLATUM 1 g/g 37012-070_061b13c2-5bbc-4d35-a13b-c96fc460113f 37012-070 HUMAN OTC DRUG Miconazole 3 Miconazole Nitrate CREAM VAGINAL 20050302 ANDA ANDA076773 Shopko Stores Operating Co., LLC MICONAZOLE NITRATE 40 mg/g 37012-072_f5078528-67fe-4e6f-875b-8710fde63009 37012-072 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL MOUTHWASH ORAL 20080108 OTC MONOGRAPH NOT FINAL part348 Shopko EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 37012-074_c20cc954-1490-4575-96cf-1720509bd589 37012-074 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20130819 ANDA ANDA077349 Shopko Stores Operating Co., LLC IBUPROFEN 200 mg/1 37012-075_bb9d981c-00df-46ec-973b-4dd17a54068a 37012-075 HUMAN OTC DRUG Shopko Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Shopko Stores Operating Co., LLC BACITRACIN ZINC 500 [iU]/g 37012-076_16730c70-ef40-49bb-b5ac-86fb703bbe65 37012-076 HUMAN OTC DRUG Shopko Chest Congestion Relief Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Shopko GUAIFENESIN 400 mg/1 37012-077_096b79d6-3275-42b2-99ba-fed836ade8dc 37012-077 HUMAN OTC DRUG Skopko Chest Congestion Relief PE PE Guaifenesin/phenylephrine TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 Shopko GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 37012-078_18efbd68-d3c4-4058-a305-56dfbb79dd2c 37012-078 HUMAN OTC DRUG Shopko Chest Congestion Relief DMTDM TDM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Shopko DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 37012-080_a6b8ac61-c68f-4fc2-b8be-e1d779211017 37012-080 HUMAN OTC DRUG Shopko Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Shopko Stores Operating Co., LLC TERBINAFINE HYDROCHLORIDE 1 g/100g 37012-089_c7be4695-4097-473e-a126-0d8e3516e9cc 37012-089 HUMAN OTC DRUG Shopko Anti-Itch diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20050920 OTC MONOGRAPH NOT FINAL part348 Shopko Stores Operating Co., LLC DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g 37012-090_91ce7f8b-a188-4136-b043-e95dac3037e0 37012-090 HUMAN OTC DRUG Day Time Night Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130919 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC 37012-094_bb5577b6-38b8-4994-b887-be6b82bb5c0c 37012-094 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine Hydrochloride TABLET ORAL 20131002 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 37012-098_042fa206-9a4f-4ee4-a8e4-14fd362c8c99 37012-098 HUMAN OTC DRUG Skopko Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20130701 UNAPPROVED DRUG OTHER Skopko PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 37012-099_7e1eaf0b-d2d4-4d4a-9cb1-ad1a97954b1a 37012-099 HUMAN OTC DRUG Shopko Hydrocortisone Intensive Healing Formula Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Shopko Stores Operating Co., LLC HYDROCORTISONE 1 g/100g 37012-100_4f354db5-4692-441e-b1d0-196e77e5e52e 37012-100 HUMAN OTC DRUG SHOPKO Antibacterial Hands and Face Fresh Scent BENZALKONIUM CHLORIDE CLOTH TOPICAL 20121105 OTC MONOGRAPH NOT FINAL part333A Shopko Stores Operating Co., LLC. BENZALKONIUM CHLORIDE .13 g/1 37012-110_28787271-ff85-4a97-b90c-e3d27895b594 37012-110 HUMAN OTC DRUG stool softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC. DOCUSATE SODIUM 100 mg/1 37012-117_18b82a67-505e-4e12-9cc1-1193ee1800a1 37012-117 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130605 ANDA ANDA202319 Shopko Stores Operating Co., LLC LANSOPRAZOLE 15 mg/1 37012-120_e9c03d25-155e-402a-8023-fd0a573e3c8f 37012-120 HUMAN OTC DRUG womans laxative Bisacodyl TABLET, COATED ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC. BISACODYL 5 mg/1 37012-121_75c97544-0b3e-411b-a9d3-b87a646a6384 37012-121 HUMAN OTC DRUG SHOPKO Maximum Strength Medicated with Aloe and Witch Hazel WITCH HAZEL CLOTH TOPICAL 20130716 OTC MONOGRAPH FINAL part346 Shopko Stores Operating Co., LLC. WITCH HAZEL 50 g/100g 37012-123_afec31fa-c850-499e-9f87-475eec5ce0d4 37012-123 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Shopko Stores Operating Co., LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 37012-127_234f3e92-c5c5-4f28-b29e-619854e2b44b 37012-127 HUMAN OTC DRUG Ranitidine Ranitidine TABLET ORAL 20100711 ANDA ANDA078653 Shopko Stores Operating Co., LLC. RANITIDINE HYDROCHLORIDE 150 mg/1 37012-160_50f66c5a-7776-49d5-99cc-91e431682c55 37012-160 HUMAN OTC DRUG Hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20130806 OTC MONOGRAPH FINAL part346 Shopko Stores Operating Co., LLC COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g 37012-161_4853b96a-c11b-41de-bd1c-9db3668f9363 37012-161 HUMAN OTC DRUG Pain Relief Acetaminophen SUSPENSION ORAL 20140813 OTC MONOGRAPH NOT FINAL part343 Shopko Stores Operating Co., LLC ACETAMINOPHEN 160 mg/5mL 37012-163_5a236a0e-5aa8-4854-8a5e-c4c58579610f 37012-163 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20060513 OTC MONOGRAPH FINAL part355 ShopKo Stores Operating Co., LLC SODIUM FLUORIDE .1 mg/mL 37012-165_05454987-6336-461e-87db-2ede9c275a5b 37012-165 HUMAN OTC DRUG allergy relief-d Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20140226 ANDA ANDA075706 Shopko Stores Operating Co., LLC LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 37012-175_969bb347-49e1-4d4b-a136-4185c4b708e9 37012-175 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen SUSPENSION ORAL 20131031 OTC MONOGRAPH NOT FINAL part343 Shopko Stores Operating Co., LLC ACETAMINOPHEN 160 mg/5mL 37012-176_5fdc7581-e555-493e-8fa1-0fe3571d875a 37012-176 HUMAN OTC DRUG Allergy Relief D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20130907 ANDA ANDA077170 Shopko Stores Operating Co., LLC CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 37012-189_c15a09cc-bd0a-4b2c-b102-cdadcbfc2f03 37012-189 HUMAN OTC DRUG Fexofenadine HCl Fexofenadine HCl TABLET ORAL 20120611 ANDA ANDA079112 Shopko Stores Operating Co., LLC. FEXOFENADINE HYDROCHLORIDE 180 mg/1 37012-194_4008deff-ef90-4de7-9f7a-0dbdf32b8105 37012-194 HUMAN OTC DRUG Acid Controller Famotidine TABLET ORAL 20130717 ANDA ANDA077351 Shopko Stores Operating Co., LLC FAMOTIDINE 20 mg/1 37012-199_5b630b51-cb5c-4f12-ad57-c54bd8d4b30f 37012-199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100709 ANDA ANDA078682 Shopko Stores Operating Co., LLC. IBUPROFEN 200 mg/1 37012-204_de0f0d0a-d2aa-4580-bc53-3e26bfde12b5 37012-204 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Shopko Stores Operating Co., LLC PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 37012-213_cd961084-2fb6-4265-b9dd-ebd0e7a5865b 37012-213 HUMAN OTC DRUG Anticavity Sodium Fluoride RINSE ORAL 20110602 OTC MONOGRAPH FINAL part355 ShopKo Stores SODIUM FLUORIDE .05 mg/mL 37012-224_a89682f7-41f2-47cb-ae49-995a6216abd7 37012-224 HUMAN OTC DRUG anti diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20030307 ANDA ANDA075232 Shopko Stores Operating Co., LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 37012-227_07209d28-eab2-482d-bb78-75e18f202cc1 37012-227 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20131211 OTC MONOGRAPH NOT FINAL part343 Shopko Stores Operating Co., LLC ACETAMINOPHEN 500 mg/1 37012-238_c7ea393a-495b-4a30-9aeb-de0ce5228df0 37012-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140315 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC. DOCUSATE SODIUM 100 mg/1 37012-243_7785374e-8ef1-4b55-95d5-22ffe6a89186 37012-243 HUMAN OTC DRUG Handsoap Triclosan LIQUID TOPICAL 20090210 OTC MONOGRAPH NOT FINAL part333A ShopKo Stores Operating Co., LLC TRICLOSAN 1.545 mg/mL 37012-255_d1bf3a9f-1e67-4ebe-8730-8d0e390de91b 37012-255 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20130730 ANDA ANDA075217 Shopko Stores Operating Co., LLC IBUPROFEN 50 mg/1.25mL 37012-271_69fbf788-58f9-4286-9d14-64830d47ab7e 37012-271 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20130610 ANDA ANDA076760 Shopko Stores Operating Co., LLC RANITIDINE HYDROCHLORIDE 75 mg/1 37012-272_13ab3b2a-d7bf-4d0f-9507-df2f5bdc6e12 37012-272 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130909 ANDA ANDA072096 Shopko Stores Operating Co., LLC IBUPROFEN 200 mg/1 37012-279_aadcdc22-d47a-469d-bfb2-953c01dc13fa 37012-279 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141029 OTC MONOGRAPH FINAL part346 Shopko Stores Operating Co., LLC COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 37012-296_a87b894e-0e4b-46f8-a4f8-b59c15d44089 37012-296 HUMAN OTC DRUG Tussin CF Max dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20140206 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL 37012-299_01f77aa9-910f-433b-8392-751b19d94806 37012-299 HUMAN OTC DRUG Antiseptic Cetylpyridinium chloride MOUTHWASH ORAL 20090813 OTC MONOGRAPH NOT FINAL part356 Shopko Stores Operating CETYLPYRIDINIUM CHLORIDE .7 mg/mL 37012-302_af5fbc34-5c27-418b-88a9-94554d1ffb2f 37012-302 HUMAN OTC DRUG Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 20131114 OTC MONOGRAPH FINAL part335 Shopko Stores Operating Co., LLC BISMUTH SUBSALICYLATE 525 mg/30mL 37012-304_3f2162cb-3a22-4826-90fe-0efbead0ab13 37012-304 HUMAN OTC DRUG Nasal oxymetazoline hydrochloride SPRAY NASAL 20130711 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 37012-306_0bd40185-aa67-4992-813b-14e971669a63 37012-306 HUMAN OTC DRUG clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20130605 ANDA ANDA090685 Shopko Stores Operating Co., LLC POLYETHYLENE GLYCOL 3350 17 g/17g 37012-321_431e098a-6a11-405e-be48-3044297d3953 37012-321 HUMAN OTC DRUG Acid Controller Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20130605 ANDA ANDA077355 Shopko Stores Operating Co., LLC CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 37012-326_239d49ad-58d3-4c48-b6fc-38ef479e5521 37012-326 HUMAN OTC DRUG ShopKo Illuminating Daily Moisturizer Broad Spectrum SPF15 Sunscreen Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Shopko Stores Operating Co., LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 mg/100mL; mg/100mL; mg/100mL 37012-332_a4814156-7f7c-4437-bc05-ccc6cbd26af6 37012-332 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 20130624 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC MAGNESIUM HYDROXIDE 1200 mg/15mL 37012-333_74d80c8c-fd10-4aac-9fbf-0821d434f28a 37012-333 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Shopko Stores Operating Co., LLC ACETAMINOPHEN 650 mg/1 37012-335_c4abe961-54f1-4564-9aa3-2ee860a30283 37012-335 HUMAN OTC DRUG Nighttime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20130805 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 37012-337_202d1fe6-b45b-44a2-a63d-80317bda6c4f 37012-337 HUMAN OTC DRUG Stomach Relief Bismuth subsalicylate LIQUID ORAL 20130919 OTC MONOGRAPH FINAL part335 Shopko Stores Operating Co., LLC BISMUTH SUBSALICYLATE 1050 mg/30mL 37012-340_daaf24d3-fec2-4bba-8aa0-34a5daac0973 37012-340 HUMAN OTC DRUG antacid aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 20130605 OTC MONOGRAPH FINAL part331 Shopko Stores Operating Co., LLC ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 37012-351_5e4f79dd-4223-4bb2-9335-b195fc32eed6 37012-351 HUMAN OTC DRUG Ranitidine Ranitidine TABLET ORAL 20120330 ANDA ANDA200536 Shopko Stores Operating Co., LLC RANITIDINE HYDROCHLORIDE 150 mg/1 37012-357_646c5afe-9e00-4de1-8be6-7ad49ab3c2e1 37012-357 HUMAN OTC DRUG antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20140519 OTC MONOGRAPH FINAL part331 Shopko Stores Operating Co., LLC ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 37012-359_5fa8e403-9bff-44f1-be79-061dfe4e0fa5 37012-359 HUMAN OTC DRUG Adults Tussin DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20130708 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 37012-368_b088dbc5-483c-45f9-9876-378d8843efff 37012-368 HUMAN OTC DRUG naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20140519 ANDA ANDA074661 Shopko Stores Operating Co., LLC NAPROXEN SODIUM 220 mg/1 37012-370_b8a71539-89af-48c1-b155-7b0e085d256c 37012-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part333A ShopKo Stores Operating Co., LLC ALCOHOL 70 mL/100mL 37012-374_0df1e6fe-356d-47c5-9856-e9fe3d789260 37012-374 HUMAN OTC DRUG Migraine Relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20020701 ANDA ANDA075794 Shopko Stores Operating Co., LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 37012-379_65163a6d-31a8-45b4-ac92-4986af1e35eb 37012-379 HUMAN OTC DRUG Childrens Allergy Relief Diphenhydramine HCl LIQUID ORAL 20130912 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 37012-384_8db08a9e-6c66-4ea3-8096-40e307f4fc43 37012-384 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130708 ANDA ANDA091135 Shopko Stores Operating Co., LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 37012-388_05c5571a-cb1b-4918-b08a-eec47ff74753 37012-388 HUMAN OTC DRUG nasal mist Oxymetazoline HCl SPRAY NASAL 20140924 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 37012-396_1f2c44ee-3147-4527-935d-9c7a39cc23cd 37012-396 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide SUSPENSION ORAL 20130605 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC MAGNESIUM HYDROXIDE 1200 mg/15mL 37012-407_18f673d3-d34e-46ec-adcd-dfe7f0e1ca6f 37012-407 HUMAN OTC DRUG ShopKo Cold Sore Treatment Camphor CREAM TOPICAL 20130416 OTC MONOGRAPH NOT FINAL part348 ShopKo Stores Operating Co., LLC BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g 37012-408_fc0f51f4-730e-40b0-a051-391a847420ef 37012-408 HUMAN OTC DRUG Shopko Maximum Strength Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Shopko Stores Operating Co., LLC HYDROCORTISONE 1 g/100g 37012-412_2ddfea2d-2804-4f69-a3fc-cf096a711974 37012-412 HUMAN OTC DRUG Antibacterial Body Wash Benzalkonium chloride LOTION TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part333A Shopko Stores Operating Co.LLC BENZALKONIUM CHLORIDE 1.313 mg/mL 37012-432_a0f0a41c-f3fa-4651-a015-cfb424608c8d 37012-432 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130907 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 37012-439_4974a5a1-a665-4356-8fc8-4b0fa831f078 37012-439 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohl LIQUID TOPICAL 20130102 OTC MONOGRAPH NOT FINAL part333A Shopko Stores Operating Co., LLC ALCOHOL 616 mg/mL 37012-458_b4326b10-26c7-432b-a928-f6af2e3edc17 37012-458 HUMAN OTC DRUG Allergy Relief Cetirizine Hydrochloride TABLET ORAL 20130708 ANDA ANDA078336 Shopko Stores Operating Co., LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 37012-459_602300c9-fc4c-49f2-b5b4-318b8442b0c7 37012-459 HUMAN OTC DRUG cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20130805 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 37012-461_40097d6e-588f-42db-a4f5-77f7d9692414 37012-461 HUMAN OTC DRUG Junior Strength Ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20130730 ANDA ANDA076359 Shopko Stores Operating Co., LLC IBUPROFEN 100 mg/1 37012-469_66e97c79-70cb-48d4-8a50-f0cf032958c8 37012-469 HUMAN OTC DRUG Stomach Relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20140101 OTC MONOGRAPH FINAL part335 Shopko Stores Operating Co., LLC BISMUTH SUBSALICYLATE 262 mg/1 37012-470_e4ee3571-abba-4769-bd98-87c116c2dd57 37012-470 HUMAN OTC DRUG Day Time Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20110325 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 37012-477_b9c9e0e9-504d-46e9-bfab-8d1af5398b83 37012-477 HUMAN OTC DRUG Fiber Laxative Calcium polycarbophil TABLET, FILM COATED ORAL 20130919 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC CALCIUM POLYCARBOPHIL 625 mg/1 37012-479_78d4fb3b-7c3d-497d-b792-74a6b567b0e7 37012-479 HUMAN OTC DRUG Allergy Relief Diphenhydramine Hydrochloride TABLET ORAL 20130909 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 37012-480_ac01829e-66b0-4d32-914f-2be9f32b14f0 37012-480 HUMAN OTC DRUG Night time cold/flu relief multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20120830 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 37012-482_29eff768-abdf-4919-a27b-c55269841aaf 37012-482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 19820715 OTC MONOGRAPH FINAL part355 ShopKo Stores Operating., LLC SODIUM FLUORIDE .1 mg/mL 37012-484_04a1f448-7278-4ae8-86df-9dd65977b163 37012-484 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET ORAL 20130808 OTC MONOGRAPH NOT FINAL part343 Shopko Stores Operating Co., LLC ACETAMINOPHEN 500 mg/1 37012-486_361bd868-5450-4d88-99fd-490a1fd9c78e 37012-486 HUMAN OTC DRUG Stool Softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20130613 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC DOCUSATE SODIUM 100 mg/1 37012-490_bb47e779-44e4-48b7-a392-fe3428a0eae1 37012-490 HUMAN OTC DRUG DayTime Nighttime multi symptom cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120510 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC. 37012-498_d30b40bc-3723-4b95-828e-39f39c0ced41 37012-498 HUMAN OTC DRUG Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130708 ANDA ANDA078912 Shopko Stores Operating Co., LLC GUAIFENESIN 600 mg/1 37012-499_a5c384e1-ae85-4749-99d5-f04649fdf795 37012-499 HUMAN OTC DRUG Shopko Alcohol Swabs Isopropyl Alcohol SWAB TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part333A SHOPKO STORES OPERATING CO., LLC ISOPROPYL ALCOHOL 70 mL/100mL 37012-506_d0a3d86c-f17d-431b-9177-ce5791f86056 37012-506 HUMAN OTC DRUG Shopko Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Shopko Stores Operating Co., LLC NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g 37012-516_28230b06-558f-4f4b-aa0d-77d08d00a5fb 37012-516 HUMAN OTC DRUG Tussin CF Cough and Cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20130708 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 37012-521_fd3db5ab-f9ac-4a16-a550-27ab99854690 37012-521 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20130806 ANDA ANDA076359 Shopko Stores Operating Co., LLC IBUPROFEN 100 mg/1 37012-523_9397de15-2a99-47f9-b0ca-99faf37fea80 37012-523 HUMAN OTC DRUG Shopko Healing Petrolatum OINTMENT TOPICAL 20140501 OTC MONOGRAPH FINAL part347 Shopko Stores Operating Co., LLC PETROLATUM 41 g/100g 37012-526_21c4e5cc-a1e7-467c-ab88-a2cde5b56c68 37012-526 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Shopko Stores Operating Co., LLC LORATADINE 10 mg/1 37012-527_03adedd8-1cda-4e10-a2a2-5680a260809e 37012-527 HUMAN OTC DRUG Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Shopko Stores Operating Co., LLC LORATADINE 10 mg/1 37012-544_1a952e86-25f3-46df-8d46-0139d3aad015 37012-544 HUMAN OTC DRUG Arthritis Pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131002 ANDA ANDA075077 Shopko Stores Operating Co., LLC ACETAMINOPHEN 650 mg/1 37012-546_3b913503-167c-49f3-8564-e7f6a5856666 37012-546 HUMAN OTC DRUG Acid Controller Complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20130605 ANDA ANDA077355 Shopko Stores Operating Co., LLC CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 37012-550_6328825e-75af-4446-8e0b-19dd3c7b504b 37012-550 HUMAN OTC DRUG Extra Strength Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20100602 OTC MONOGRAPH FINAL part332 Shopko Stores Operating Co., LLC. DIMETHICONE 125 mg/1 37012-571_1199bfb6-5844-4493-b0ce-12c9774dc681 37012-571 HUMAN OTC DRUG Allergy Relief fexofenadine hcl TABLET, FILM COATED ORAL 20130708 ANDA ANDA076447 Shopko Stores Operating Co., LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 37012-580_568e359d-c474-45c9-8fc9-75ceca42e0d8 37012-580 HUMAN OTC DRUG Daytime Nighttime Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140603 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC 37012-588_1082c62b-9968-4327-b26e-adeba9e98cae 37012-588 HUMAN OTC DRUG Antacid Aluminum Hydroxide, Magnesium Hydroxide, Simethicone LIQUID ORAL 20130605 OTC MONOGRAPH FINAL part332 Shopko Stores Operating Co., LLC ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 37012-602_6dcf08d6-66db-4692-be4e-918bc0b79db5 37012-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20090605 OTC MONOGRAPH NOT FINAL part334 ShopKo Stores Operating Co., LLC MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g 37012-604_d2e98cdd-e5f2-47ea-b538-cd8c1144b917 37012-604 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130909 ANDA ANDA072096 Shopko Stores Operating Co., LLC IBUPROFEN 200 mg/1 37012-612_47b0f9c5-3986-4439-8a05-cb212f9878d3 37012-612 HUMAN OTC DRUG Allergy Relief Loratadine TABLET ORAL 20130912 ANDA ANDA076301 Shopko Stores Operating Co., LLC LORATADINE 10 mg/1 37012-626_0111e51d-63c3-43a6-8c55-9f7b96315a3c 37012-626 HUMAN OTC DRUG ShopKo Absolute Daily Moisturizing Broad Spectrum SPF15 Sunscreen Avobenzone, Homosalate, Octinoxate, Octocrylene CREAM TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Shopko Stores Operating Co., LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3; 3; 5; 2.6 mg/100mL; mg/100mL; mg/100mL; mg/100mL 37012-645_bce5ade5-e811-485e-93e7-52fbf0a397ad 37012-645 HUMAN OTC DRUG Loperamide Hydrochloride loperamide HCl LIQUID ORAL 20130808 ANDA ANDA091292 Shopko Stores Operating Co., LLC LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 37012-647_8466941c-3c5a-436f-9056-30c9fe58ae51 37012-647 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20130912 ANDA ANDA072096 Shopko Stores Operating Co., LLC IBUPROFEN 200 mg/1 37012-656_d1b370b9-3a7b-4511-89e8-d7c79639a1f8 37012-656 HUMAN OTC DRUG Daytime Cold and Flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20130805 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 37012-657_03dace6d-ec79-4506-acfe-47ce10822920 37012-657 HUMAN OTC DRUG Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20130613 OTC MONOGRAPH FINAL part332 Shopko Stores Operating Co., LLC DIMETHICONE 180 mg/1 37012-664_839eecd2-783c-44fe-9d2f-b78332c78fdc 37012-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20080102 OTC MONOGRAPH NOT FINAL part356 Shopko Store Operating Co, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 37012-667_6c90d9f3-fb99-4f2e-ab97-554b6c684401 37012-667 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19890715 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co LLC MAGNESIUM CITRATE 1.745 g/29.6mL 37012-668_9b37fc26-e729-4279-8d1e-aec0c5e33547 37012-668 HUMAN OTC DRUG Nighttime Cough Relief Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20130819 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 37012-724_cf3b5ddf-633a-400d-9d13-996ff10fa9a5 37012-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Shopko Stores Operating Co., LLC LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 37012-726_b5651425-ce91-43c8-bc12-02c8a65b0dea 37012-726 HUMAN OTC DRUG ShopKo Absolute Daily Moisturizer SPF15 Sensitive Skin Octinoxate, Zinc Oxide, Avobenzone CREAM TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Shopko Stores Operating Co., LLC AVOBENZONE; OCTINOXATE; ZINC OXIDE 1; 6; 3 mg/100mL; mg/100mL; mg/100mL 37012-731_d923ebdd-a031-4792-832e-e6af33c3ba9f 37012-731 HUMAN OTC DRUG Shopko Cherry SPF 4 Lip Balm Padimate O, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Shopko PADIMATE O; PETROLATUM 1.5; 44 mg/g; mg/g 37012-732_cd728da3-5da1-41c3-8752-d8b3daf381a5 37012-732 HUMAN OTC DRUG Shopko Original SPF 4 Lip Balm Padimate O, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Shopko PADIMATE O; PETROLATUM 1.5; 44 mg/g; mg/g 37012-733_9f196c4c-1100-4626-9051-7b9e1fe67215 37012-733 HUMAN OTC DRUG Shopko Moisture SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Shopko OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 40.7 mg/g; mg/g; mg/g 37012-734_8b92923f-8dff-4736-b1fb-35ac03f82bcb 37012-734 HUMAN OTC DRUG Shopko Camphor Phenol Gel Camphor, Phenol GEL TOPICAL 20130315 OTC MONOGRAPH FINAL part346 Shopko CAMPHOR (SYNTHETIC); PHENOL 10.8; 4.7 mg/g; mg/g 37012-735_dd46770d-b1e3-4488-b31c-c2e1a461936e 37012-735 HUMAN OTC DRUG Shopko Medicated Lip Treatment Camphor, Phenol GEL TOPICAL 20130315 OTC MONOGRAPH FINAL part346 Shopko CAMPHOR (SYNTHETIC); MENTHOL 1.7; .7 mg/g; mg/g 37012-736_5c674aab-067d-48bf-a839-a4aca4c01466 37012-736 HUMAN OTC DRUG Shopko Lip Treatment Petrolatum GEL TOPICAL 20130502 OTC MONOGRAPH FINAL part347 Shopko PETROLATUM 99.98 mg/g 37012-737_3dc95764-6f45-4f6e-9a4d-f08a84efd869 37012-737 HUMAN OTC DRUG Shopko Medicated Lip Balm Petrolatum STICK TOPICAL 20130311 OTC MONOGRAPH FINAL part347 Shopko PETROLATUM 41 mg/g 37012-742_274dd0d9-6572-49e5-9677-062a5e83fe3f 37012-742 HUMAN OTC DRUG Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20130730 NDA NDA021920 Shopko Stores Operating Co., LLC NAPROXEN SODIUM 220 mg/1 37012-751_fb9ef97b-3fa7-47d2-8b89-3aff40b3bede 37012-751 HUMAN OTC DRUG Pain Relief PM Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20131031 OTC MONOGRAPH NOT FINAL part343 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 37012-810_ef5b4d18-8887-4f2b-97d7-bde0dcbfeb75 37012-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20080102 OTC MONOGRAPH NOT FINAL part333A Shopko Stores Operating Co ISOPROPYL ALCOHOL 500 mg/mL 37012-815_82897622-4dc7-4154-8e3e-919214d20d2e 37012-815 HUMAN OTC DRUG Shopko Anti-Wrinkle and Firming Moisturizer Day Broad Spectrum SPF18 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Shopko Stores Operating Co., LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 5 g/100g; g/100g; g/100g 37012-822_3c454386-6a7c-4baf-868c-62d830144c3f 37012-822 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 20080108 OTC MONOGRAPH FINAL part346 Shopko Stores Operating Co., LLC WITCH HAZEL 979 mg/mL 37012-831_3ad56a1c-bfa9-4605-a283-da825ad7d79a 37012-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 20080102 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC MINERAL OIL 999 mg/mL 37012-845_3f63b81d-f741-4012-bf3a-23724d754166 37012-845 HUMAN OTC DRUG 70% Rubbing Isopropyl Alcohol LIQUID TOPICAL 20080131 OTC MONOGRAPH NOT FINAL part333A ShopKo ISOPROPYL ALCOHOL 500 mg/mL 37012-851_71dc0f59-0093-4d40-b3bf-d7740d2db4d9 37012-851 HUMAN OTC DRUG Antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20140514 OTC MONOGRAPH FINAL part332 Shopko Stores Operating Co., LLC ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 37012-852_9d178dc6-29c8-4a57-ba35-426c00069c7e 37012-852 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20130605 ANDA ANDA091429 Shopko Stores Operating Co., LLC RANITIDINE HYDROCHLORIDE 150 mg/1 37012-871_6bc190c9-45ad-4ae6-8f01-86dfbab9423c 37012-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20090122 OTC MONOGRAPH NOT FINAL part333A Shopko Stores Operating Co, LLC HYDROGEN PEROXIDE 30 mg/mL 37012-882_c6156db9-9000-463c-92da-b1d670811987 37012-882 HUMAN OTC DRUG Infants Gas Relief Simethicone EMULSION ORAL 20131127 OTC MONOGRAPH FINAL part332 Shopko Stores Operating Co., LLC DIMETHICONE 20 mg/.3mL 37012-897_838f803d-4233-462a-968e-f1cae36c1afd 37012-897 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20130730 ANDA ANDA074937 Shopko Stores Operating Co., LLC IBUPROFEN 100 mg/5mL 37012-915_c9ac950e-0ad7-4c90-a457-1b69c38ee21c 37012-915 HUMAN OTC DRUG Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20130605 NDA NDA022032 Shopko Stores Operating Co., LLC OMEPRAZOLE 20 mg/1 37012-927_28c365af-c8d0-4e39-ace1-58eb04f862a5 37012-927 HUMAN OTC DRUG Shopko Diaper Rash Maximum Strength Zinc Oxide CREAM TOPICAL 20131210 OTC MONOGRAPH FINAL part347 Shopko Stores Operating Co., LLC ZINC OXIDE 40 g/100g 37012-939_42ca6e02-05a3-432f-82c9-80c0d9d83dcd 37012-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine TABLET ORAL 20071227 ANDA ANDA077498 Shopko Stores Operating Co., LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 37012-945_850f16cc-5219-49ec-9d4d-14b32b4ba1cd 37012-945 HUMAN OTC DRUG Body Wash triclosan LIQUID TOPICAL 20090318 OTC MONOGRAPH NOT FINAL part333A ShopKo Stores Operating Co., LLC TRICLOSAN 1.545 mg/mL 37012-949_1dd5ab45-1110-4a37-9a47-fbab26ffad56 37012-949 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide LIQUID ORAL 20130605 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC MAGNESIUM HYDROXIDE 1200 mg/15mL 37012-950_dfaf1add-d39a-4f97-9e8a-130448903ee9 37012-950 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20130605 ANDA ANDA091429 Shopko Stores Operating Co., LLC RANITIDINE HYDROCHLORIDE 150 mg/1 37012-962_1b84fc41-8d70-4466-b323-4fad9274b68a 37012-962 HUMAN OTC DRUG Foaming Hand Wash Triclosan 0.46% LIQUID TOPICAL 20120724 OTC MONOGRAPH NOT FINAL part333A Shopko Stores Operating Co., LLC TRICLOSAN .46 mg/mL 37012-974_1caf4be5-e3bc-4455-bc1e-7f389d9f6d98 37012-974 HUMAN OTC DRUG Childrens Allergy Relief cetirizine hydrochloride LIQUID ORAL 20130708 ANDA ANDA090254 Shopko Stores Operating Co., LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL 37012-977_ea8664ad-4bfa-4c97-8a1c-1e76592aa8ed 37012-977 HUMAN OTC DRUG Night Time Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130919 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 37012-994_3f815c9f-24fc-4368-af92-bf4a2980585a 37012-994 HUMAN OTC DRUG Day Time Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20130912 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 37205-008_639f5643-0ddb-4695-a505-4be3559fe807 37205-008 HUMAN OTC DRUG leader pain reliever infants concentrated Acetaminophen SUSPENSION/ DROPS ORAL 19900515 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 80 mg/.8mL 37205-009_e04faa2d-e2ae-4762-8eef-144fb209d906 37205-009 HUMAN OTC DRUG LEADER Camphor Spirit CAMPHOR (NATURAL) LIQUID TOPICAL 20120315 OTC MONOGRAPH FINAL part348 Cardinal Health CAMPHOR (NATURAL) 10 mL/100mL 37205-012_b968c2ba-9351-4722-a522-39b0d7019505 37205-012 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120509 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL 500 mg/mL 37205-020_220556b2-9ea9-4f74-88ea-cd2014251b3a 37205-020 HUMAN OTC DRUG leader pain reliever extra strength Acetaminophen CAPSULE, COATED ORAL 20110216 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 500 mg/1 37205-022_ad32b4cf-9095-410f-a709-986297484833 37205-022 HUMAN OTC DRUG LEADER Mild Iodine IODINE,SODIUM IODIDE, ALCOHOL TINCTURE TOPICAL 20120315 OTC MONOGRAPH FINAL part333A Cardinal Health ALCOHOL; IODINE; SODIUM IODIDE 47; 2; 2.4 mL/100mL; mL/100mL; mL/100mL 37205-023_05683c9a-5688-4f50-8e7a-442e7c6f68fd 37205-023 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20100831 OTC MONOGRAPH FINAL part349 Cardinal Health WATER 99.05 mL/100mL 37205-024_bf5dabfa-6e8f-4dc3-bd69-0fff7bbd00f1 37205-024 HUMAN OTC DRUG LEADER Castor CASTOR OIL OIL ORAL 20120315 OTC MONOGRAPH FINAL part334 Cardinal Health CASTOR OIL 100 mL/100mL 37205-030_8cf67d87-527b-4753-95d3-8879b96a25f7 37205-030 HUMAN OTC DRUG Leader Enema Saline ENEMA RECTAL 20091120 OTC MONOGRAPH NOT FINAL part334 Cardinal Health SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 37205-031_ef4292af-40e0-4df9-b37f-597334d71b43 37205-031 HUMAN OTC DRUG leader pain reliever Acetaminophen TABLET ORAL 19900515 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 325 mg/1 37205-034_f8bb1520-34d2-4b2c-822b-d9e0d0f90f53 37205-034 HUMAN OTC DRUG Leader Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Cardinal Health ACETAMINOPHEN 650 mg/1 37205-060_c961b9ae-595e-4086-b041-02b4492b440d 37205-060 HUMAN OTC DRUG Leader Pain Reliever PM Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19920707 OTC MONOGRAPH FINAL part338 Cardinal Health ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 37205-064_df5976d2-5e06-47f3-9173-66c290d10b3a 37205-064 HUMAN OTC DRUG Leader enema mineral oil ready to use Mineral Oil LIQUID RECTAL 20091201 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MINERAL OIL 100 mL/100mL 37205-067_ece38e98-b911-4a25-813c-c751b291e71b 37205-067 HUMAN OTC DRUG leader nasal Oxymetazoline HCl SPRAY NASAL 19961205 OTC MONOGRAPH FINAL part341 Cardinal Health OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 37205-069_19d19fa8-e565-44c9-9187-168d1258d7a5 37205-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 19970621 OTC MONOGRAPH FINAL part347 Cardinal Health PETROLATUM 100 kg/100kg 37205-102_4e9287f3-87a6-967b-8f68-b81821a4b2fe 37205-102 HUMAN OTC DRUG Bisacodyl Bisacodyl SUPPOSITORY RECTAL 19970910 OTC MONOGRAPH NOT FINAL part334 CARDINAL HEALTH, INC. BISACODYL 10 mg/1 37205-110_52c94d1a-41a4-4389-80be-3cd73be0806e 37205-110 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 19890621 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MAGNESIUM CITRATE 1.745 g/29.6mL 37205-111_69493a94-f35d-42d3-ba4f-f851b8daaaff 37205-111 HUMAN OTC DRUG Original Formula Motion Sickness Relief DIMENHYDRINATE TABLET ORAL 20120626 OTC MONOGRAPH FINAL part336 Cardinal Health (Leader) 37205 DIMENHYDRINATE 50 mg/1 37205-112_0d339cc5-d77c-4c09-bb9d-0828b97a9a30 37205-112 HUMAN OTC DRUG Gas Relief Simethicone TABLET, CHEWABLE ORAL 19940728 OTC MONOGRAPH FINAL part332 CARDINAL HEALTH DIMETHICONE 80 mg/1 37205-117_f2f01039-1739-493f-8b6f-3c0e68c6bda3 37205-117 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA040829 Cardinal Health, Inc. CHLORPHENIRAMINE MALEATE 12 mg/1 37205-119_41936f0b-c098-4958-83c7-35a664034930 37205-119 HUMAN OTC DRUG Leader Infants Gas Relief Simethicone EMULSION ORAL 20100308 OTC MONOGRAPH FINAL part332 Cardinal Health DIMETHICONE 20 mg/.3mL 37205-120_15d8a696-015f-4cd2-911d-9f93bf80ff6f 37205-120 HUMAN OTC DRUG Leader Maximum Strength Sleep Aid DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20120605 OTC MONOGRAPH FINAL part338 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 37205-121_3a259420-6b3c-418a-be1e-9cbac1d247e6 37205-121 HUMAN OTC DRUG Leader sleep aid Doxylamine succinate TABLET ORAL 19971021 ANDA ANDA040167 Cardinal Health DOXYLAMINE SUCCINATE 25 mg/1 37205-122_60511df9-a1bc-4445-a3ca-df83f5977fe8 37205-122 HUMAN OTC DRUG LEADER ORAL ANALGESIC BENZOCAINE GEL ORAL 20120501 OTC MONOGRAPH FINAL part333B CARDINAL HEALTH BENZOCAINE 20 g/100g 37205-128_4487b7f9-9351-4b61-a246-1e890677014f 37205-128 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET ORAL 20111014 OTC MONOGRAPH NOT FINAL part334 Cardinal Health BISACODYL 5 mg/1 37205-130_31ba9070-83e2-453d-aa49-82c646e83c9c 37205-130 HUMAN OTC DRUG LEADER Caldyphen ZINC OXIDE, PRAMOXINE HYDROCHLORIDE LOTION TOPICAL 20120315 OTC MONOGRAPH FINAL part348 Cardinal Health PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 1; 8 mL/100mL; mL/100mL 37205-134_3f12cba7-2772-4eb7-ac82-2a53d517c3ba 37205-134 HUMAN OTC DRUG Dry Eyes white petrolatum mineral oil OINTMENT OPHTHALMIC 20111115 OTC MONOGRAPH FINAL part349 Cardinal Health MINERAL OIL; PETROLATUM 150; 830 mg/g; mg/g 37205-137_6e60afeb-8e96-48e1-82d1-6f6c354f2ef6 37205-137 HUMAN OTC DRUG Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20111115 OTC MONOGRAPH FINAL part349 Cardinal Health POLYVINYL ALCOHOL 14 mg/mL 37205-138_30886773-26c2-4293-98ff-232772e3490b 37205-138 HUMAN OTC DRUG LEADER RELIEF EYE TETRAHYDROZOLINE HCL, ZINC SULFATE SOLUTION/ DROPS OPHTHALMIC 20120104 OTC MONOGRAPH FINAL part349 CARDINAL HEALTH TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL 37205-139_42a5fb5e-4f25-4eea-b99f-be7dd13a5d64 37205-139 HUMAN OTC DRUG LEADER ORIGINAL FORMULA TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20120104 OTC MONOGRAPH FINAL part349 CARDINAL HEALTH TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 37205-145_f39ef03e-1df7-4710-b23f-c929e80fa705 37205-145 HUMAN OTC DRUG Leader Aspirin Aspirin TABLET ORAL 19900515 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ASPIRIN 325 mg/1 37205-155_73bc301f-1afd-4351-b56a-268bb6b4f8f3 37205-155 HUMAN OTC DRUG Antiseptic Swab isopropyl alcohol SWAB TOPICAL 20021001 OTC MONOGRAPH NOT FINAL part333E Cardinal Health ISOPROPYL ALCOHOL .7 mL/1 37205-160_81699cf8-4c9d-45de-a5a1-90326ec5e7a4 37205-160 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Cardinal Health CLOTRIMAZOLE 10 mg/g 37205-162_7b08a771-eac4-45ef-bb34-9bc3ced6accb 37205-162 HUMAN OTC DRUG LEADER HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 20120213 OTC MONOGRAPH NOT FINAL part348 CARDINAL HEALTH HYDROCORTISONE 1 g/100g 37205-165_f57a5d47-98a9-49e3-9c40-341a99fdc241 37205-165 HUMAN OTC DRUG Leader Lice Killing Maximum Strength piperonyl butoxide, pyrethrum extract SHAMPOO TOPICAL 20070719 OTC MONOGRAPH FINAL part358G Cardinal Health PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 37205-178_01b65863-85e1-45b0-9457-7342fcd298e1 37205-178 HUMAN OTC DRUG Soothing Bath Treatment Colloidal Oatmeal POWDER TOPICAL 20050721 OTC MONOGRAPH FINAL part347 Cardinal Health OATMEAL 1 g/g 37205-186_324ddc5e-ffdf-4fe4-9a38-74ea94794bcc 37205-186 HUMAN OTC DRUG LEADER Povidone - Iodine POVIDONE-IODINE SOLUTION TOPICAL 20120926 OTC MONOGRAPH FINAL part333E Cardinal Health POVIDONE-IODINE 10 g/100mL 37205-187_ed1bbf94-f77b-4baf-9bec-5818b48f785d 37205-187 HUMAN OTC DRUG leader pain reliever extra strength Acetaminophen TABLET, COATED ORAL 19960709 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 500 mg/1 37205-194_40de6e74-4152-493e-ba78-cc848fb694e0 37205-194 HUMAN OTC DRUG Leader Restfully Sleep Diphenhydramine Hydrochloride TABLET ORAL 20000915 OTC MONOGRAPH FINAL part338 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 37205-195_55f39cdd-71d0-4de8-bab5-91f839981cab 37205-195 HUMAN OTC DRUG Leader Alertness Aid Caffeine TABLET ORAL 19940210 OTC MONOGRAPH FINAL part340 Cardinal Health CAFFEINE 200 mg/1 37205-196_a2ef9c7c-1149-4f94-ac6e-8d593a846b21 37205-196 HUMAN OTC DRUG Effervescent Antacid and Pain Relief ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET, EFFERVESCENT ORAL 20061201 OTC MONOGRAPH FINAL part343 Cardinal Health Inc. ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE 1000; 325; 1916 mg/1; mg/1; mg/1 37205-197_986fae7b-2cb4-4bdf-9967-81cec6a0d6f5 37205-197 HUMAN OTC DRUG LEADER ANTIFUNGAL TOLNAFTATE TOLNAFTATE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part333C CARDINAL HEALTH TOLNAFTATE 10 mg/g 37205-199_c546dd47-7704-45a0-8c4c-c6d18cca4e8a 37205-199 HUMAN OTC DRUG leader ibuprofen cold and sinus Ibuprofen, Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011010 ANDA ANDA074567 Cardinal Health IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 37205-200_5e14beea-c1ef-4407-ad62-3999416f8ce0 37205-200 HUMAN OTC DRUG Leader Antacid calcium carbonate TABLET, CHEWABLE ORAL 19921005 OTC MONOGRAPH FINAL part331 Cardinal Health CALCIUM CARBONATE 500 mg/1 37205-203_294f840f-c5f4-4671-b347-1ed2b6dc0eea 37205-203 HUMAN OTC DRUG Leader Nicotine Nicotine GUM, CHEWING ORAL 20050525 ANDA ANDA076775 Cardinal Health NICOTINE 2 mg/1 37205-204_907f496d-1ea6-4c24-9d3f-949ae7dc2a64 37205-204 HUMAN OTC DRUG leader nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050525 ANDA ANDA076789 Cardinal Health NICOTINE 4 mg/1 37205-205_cb28a7f8-b908-406d-a517-5e6badde6097 37205-205 HUMAN OTC DRUG Leader Antacid Calcium carbonate TABLET, CHEWABLE ORAL 19990408 OTC MONOGRAPH FINAL part331 Cardinal Health CALCIUM CARBONATE 750 mg/1 37205-210_ef962dab-2c53-48ee-a521-9f3343b5251f 37205-210 HUMAN OTC DRUG Leader Antacid Regular Strength calcium carbonate TABLET, CHEWABLE ORAL 19920408 OTC MONOGRAPH FINAL part331 Cardinal Health CALCIUM CARBONATE 500 mg/1 37205-213_f1b28346-9338-4dfe-9752-002da637e239 37205-213 HUMAN OTC DRUG Leader Fiber Calcium polycarbophil TABLET, FILM COATED ORAL 20110502 OTC MONOGRAPH NOT FINAL part334 Cardinal Health CALCIUM POLYCARBOPHIL 625 mg/1 37205-215_384d6478-233a-49a6-aa38-f201ea7db0ff 37205-215 HUMAN OTC DRUG Allergy Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 CARDINAL HEALTH CHLORPHENIRAMINE MALEATE 4 mg/1 37205-218_cfacec36-6013-443a-85d8-0f45209a7bb5 37205-218 HUMAN OTC DRUG Effervescent Cold Relief ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE TABLET, EFFERVESCENT ORAL 20100701 OTC MONOGRAPH FINAL part341 Cardinal Health, Inc ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 37205-223_fc05700f-0a6b-4693-a3f4-3211606f660d 37205-223 HUMAN OTC DRUG Cromolyn Sodium Cromolyn Sodium SPRAY, METERED NASAL 20100703 ANDA ANDA075702 Cardinal Health CROMOLYN SODIUM 5.2 mg/mL 37205-224_ff2ed073-8e89-433c-9b9c-7643748d6428 37205-224 HUMAN OTC DRUG LEADER ADVANCED FORMULA DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL SOLUTION OPHTHALMIC 20120104 OTC MONOGRAPH FINAL part349 CARDINAL HEALTH DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .001; .01; .01; .0005 mL/mL; mL/mL; mL/mL; mL/mL 37205-227_2d09e62d-e8a4-4e1c-82a5-b2927a36dfe4 37205-227 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120510 OTC MONOGRAPH FINAL part333A Cardinal Health ISOPROPYL ALCOHOL .91 L/100L 37205-228_02201bdb-58b9-4662-a2c0-5ff3efa4a1fc 37205-228 HUMAN OTC DRUG Leader Allerhist Clemastine fumarate TABLET ORAL 19970930 ANDA ANDA074512 Cardinal Health CLEMASTINE FUMARATE 1.34 mg/1 37205-241_6ceb7f4d-8c02-4c2f-8f68-1cad196c3c1b 37205-241 HUMAN OTC DRUG Leader Senna Laxative SENNOSIDES TABLET ORAL 20120301 OTC MONOGRAPH NOT FINAL part334 Cardinal Health SENNOSIDES A AND B 8.6 mg/1 37205-243_0f5aa7b6-1105-4435-905a-16e76525c62f 37205-243 HUMAN OTC DRUG Antibacterial Triclosan SOAP TOPICAL 20071019 OTC MONOGRAPH NOT FINAL part333A Cardinal Health TRICLOSAN .15 mL/100L 37205-251_f291e3a1-8bf7-4189-873f-baac6fdb5db2 37205-251 HUMAN OTC DRUG Stool Softener plus Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20110616 OTC MONOGRAPH NOT FINAL part334 Cardinal Health (Leader) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 37205-261_5a3d0ff8-3ef7-4e56-a800-d6739820f4d1 37205-261 HUMAN OTC DRUG Leader All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 20010926 ANDA ANDA074661 Cardinal Health NAPROXEN SODIUM 220 mg/1 37205-262_e1aff053-013a-46fa-939b-0e10671bb634 37205-262 HUMAN OTC DRUG Leader All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 20120625 ANDA ANDA079096 Cardinal Health (Leader) 37205 NAPROXEN SODIUM 220 mg/1 37205-265_7bf2c411-23bf-422f-8550-0ed79e0fd805 37205-265 HUMAN OTC DRUG Leader Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120301 OTC MONOGRAPH NOT FINAL part334 Cardinal Health (Leader) DOCUSATE SODIUM 100 mg/1 37205-266_7115760f-e1ad-45e9-8651-74b8deefa7d1 37205-266 HUMAN OTC DRUG LEADER TRIPLE ANTIBIOTIC PLUS BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE OINTMENT TOPICAL 20120301 OTC MONOGRAPH FINAL part333B CARDINAL HEALTH BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 37205-270_2ac81ed7-fc9f-4637-bfdc-e5c831ca0aa0 37205-270 HUMAN OTC DRUG Leader allergy Diphenhydramine Hydrochloride TABLET ORAL 19920511 OTC MONOGRAPH FINAL part341 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 37205-272_90a3a7ed-7caa-430c-ae1a-5038f25ae207 37205-272 HUMAN OTC DRUG LEADER HYDROCORTISONE WITH ALOE HYDROCORTISONE CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 CARDINAL HEALTH HYDROCORTISONE 1 g/100g 37205-273_4269f57a-b6b3-4594-98fc-967f6e47df63 37205-273 HUMAN OTC DRUG LEADER TRIPLE ANTIBIOTIC BACITRACIN, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE OINTMENT TOPICAL 20120301 OTC MONOGRAPH FINAL part333B CARDINAL HEALTH BACITRACIN; NEOMYCIN; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 37205-275_61b73700-0c05-4244-a00f-b2ee234168f0 37205-275 HUMAN OTC DRUG LEADER BACITRACIN BACITRACIN OINTMENT TOPICAL 20120215 OTC MONOGRAPH FINAL part333B CARDINAL HEALTH BACITRACIN 500 [USP'U]/g 37205-277_3c672e00-eab5-4d40-a7d8-3deb20a2578b 37205-277 HUMAN OTC DRUG Leader Allergy Diphenhydramine hydrochloride CAPSULE ORAL 19900415 OTC MONOGRAPH FINAL part341 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 37205-278_912d4c82-5cc2-4fa9-928d-e625befe42b9 37205-278 HUMAN OTC DRUG LEADER ANTI ITCH MAXIMUM STRENGTH DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20120210 OTC MONOGRAPH FINAL part336 CARDINAL HEALTH DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 37205-279_22632df8-5a39-4cdf-aa7c-c583bd956a74 37205-279 HUMAN OTC DRUG Leader Maximum Strength Invisible Acne Benzoyl Peroxide 10% CREAM TOPICAL 20080601 OTC MONOGRAPH FINAL part333D Cardinal Health BENZOYL PEROXIDE 100 mg/g 37205-280_86bc7926-cad7-4409-87aa-232c24de410b 37205-280 HUMAN OTC DRUG Leader migraine formula Acetaminophen, Aspirin, Caffeine TABLET ORAL 20020516 ANDA ANDA075794 Cardinal Health ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 37205-281_a090349d-4704-4e33-b107-f0cbe47f61c1 37205-281 HUMAN OTC DRUG LEADER Caldyphen Clear PRAMOXINE HYDROCHLORIDE, ZINC ACETATE LOTION TOPICAL 20120315 OTC MONOGRAPH FINAL part348 Cardinal Health PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 1; .1 mL/100mL; mL/100mL 37205-282_e92cc542-bbd0-45f6-883c-6f4bedca72ed 37205-282 HUMAN OTC DRUG Leader Ibuprofen Ibuprofen SUSPENSION ORAL 20020508 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL 37205-283_3acde816-a6a6-4089-bc0a-62fe70bca781 37205-283 HUMAN OTC DRUG Leader Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20020425 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL 37205-285_71eb350d-884d-47c3-8305-2a98b98a481b 37205-285 HUMAN OTC DRUG Leader Lice Treatment Piperonyl Butoxide, Pyrethrum Extract RINSE TOPICAL 20070719 OTC MONOGRAPH FINAL part358G Cardinal Health PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL 37205-291_513472f6-eb9d-4af2-9e0d-d8d9119ab25b 37205-291 HUMAN OTC DRUG leader anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 19950616 UNAPPROVED DRUG OTHER Cardinal Health DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 37205-292_cfd92a78-926a-4856-af13-7bcc80d514cd 37205-292 HUMAN OTC DRUG leader gas relief ultra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20020304 OTC MONOGRAPH FINAL part332 Cardinal Health DIMETHICONE 180 mg/1 37205-294_d2574c2c-a7d2-45f1-9eb4-ac0f315febc8 37205-294 HUMAN OTC DRUG Leader Maximum Strength Laxative Calcium Sennosides TABLET ORAL 20120301 OTC MONOGRAPH NOT FINAL part334 Cardinal Health SENNOSIDES A AND B 25 mg/1 37205-295_71ebf7f3-942d-4084-bec4-1b5c165857a1 37205-295 HUMAN OTC DRUG Leader Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 19980916 OTC MONOGRAPH FINAL part332 Cardinal Health DIMETHICONE 125 mg/1 37205-296_e26d72cf-4c99-4dee-8212-c63b9649525a 37205-296 HUMAN OTC DRUG leader tioconastat 1 1 dose treatment Tioconazole OINTMENT VAGINAL 20080403 ANDA ANDA075915 Cardinal Health TIOCONAZOLE 6.5 g/100g 37205-298_70d6039d-a379-410d-984a-9ff8cfa599c5 37205-298 HUMAN OTC DRUG LEADER WOMENS LAXATIVE Bisacodyl TABLET, COATED ORAL 20070527 OTC MONOGRAPH NOT FINAL part334 Cardinal Health BISACODYL 5 mg/1 37205-302_6cc0b563-83cd-4865-9aa6-5f3e48015cb7 37205-302 HUMAN OTC DRUG Peptic Relief BISMUTH SUBSALICYLATE SUSPENSION ORAL 20090730 OTC MONOGRAPH FINAL part335 Leader BISMUTH SUBSALICYLATE 262 mg/15mL 37205-302_a646ed04-c6c7-405e-abcf-d84d99496a27 37205-302 HUMAN OTC DRUG Peptic Relief BISMUTH SUBSALICYLATE SUSPENSION ORAL 20090402 OTC MONOGRAPH FINAL part335 Leader BISMUTH SUBSALICYLATE 262 mg/15mL 37205-304_629dc066-dd40-4c7a-a098-dd394b29575f 37205-304 HUMAN OTC DRUG Leader Nasal oxymetazoline hydrochloride SPRAY NASAL 19920122 OTC MONOGRAPH FINAL part341 Cardinal Health OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 37205-308_cdb94bdc-f01d-4cea-b07b-ad180c559ae2 37205-308 HUMAN OTC DRUG LEADER Azo Tabs Urinary Tract Analgesic PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20041105 UNAPPROVED DRUG OTHER Cardinal Health PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 37205-311_1a7fb727-241a-4991-81b3-b9686b28b9eb 37205-311 HUMAN OTC DRUG Dandruff Shampoo PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 19980519 OTC MONOGRAPH FINAL part358 Cardinal Health PYRITHIONE ZINC 1 kg/100L 37205-314_a10d7fe4-8f21-4adb-95f6-e93e50f9a7ba 37205-314 HUMAN OTC DRUG Leader Antacid Regular Strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20021030 OTC MONOGRAPH FINAL part332 Cardinal Health ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 37205-317_fcf4baa6-c46a-a397-63cc-02f412b13da3 37205-317 HUMAN OTC DRUG Glycerin Laxative Glycerin SUPPOSITORY RECTAL 20030530 OTC MONOGRAPH NOT FINAL part334 Cardinal Health GLYCERIN 1.2 g/1 37205-318_b5d7603e-1ad8-4a3f-848c-61fc6bc6310a 37205-318 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 19900813 OTC MONOGRAPH NOT FINAL part356 Cardinal Health EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 37205-319_66f49cbf-86a9-4b46-b319-2d253890c29d 37205-319 HUMAN OTC DRUG leader pain reliever infants Acetaminophen SUSPENSION/ DROPS ORAL 19970512 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 80 mg/.8mL 37205-320_5cb10335-5132-c6cc-f3e3-34160c2d82b2 37205-320 HUMAN OTC DRUG Glycerin Laxative Glycerin SUPPOSITORY RECTAL 20020403 OTC MONOGRAPH NOT FINAL part334 Cardinal Health GLYCERIN 2.1 g/1 37205-321_83dcee7f-f061-4265-b2f4-85d798ef84fd 37205-321 HUMAN OTC DRUG Leader Heartburn Relief Cimetidine TABLET ORAL 20000204 ANDA ANDA075285 Cardinal Health CIMETIDINE 200 mg/1 37205-326_3de58373-4bbc-4f34-8090-578e02a270cf 37205-326 HUMAN OTC DRUG Leader Sore throat Phenol SPRAY ORAL 20001104 OTC MONOGRAPH NOT FINAL part356 Cardinal Health PHENOL 1.4 mL/100mL 37205-327_b0170f94-5f22-4692-b893-b4f6226c8272 37205-327 HUMAN OTC DRUG Leader Sore Throat Phenol SPRAY ORAL 20001107 OTC MONOGRAPH NOT FINAL part356 Cardinal Health PHENOL 10.628 mg/100mL 37205-328_be2a710b-ab22-4c7a-88a0-a1a5f1b3b01d 37205-328 HUMAN OTC DRUG IBUPROFEN IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20120409 ANDA ANDA078682 Cardinal Health IBUPROFEN 200 mg/1 37205-333_f6e95a3f-65a7-4e69-beb1-c2d8ff60dec8 37205-333 HUMAN OTC DRUG leader antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20030626 OTC MONOGRAPH FINAL part331 Cardinal Health CALCIUM CARBONATE 1000 mg/1 37205-336_87ca88a1-819d-4af7-b852-3433f525e100 37205-336 HUMAN OTC DRUG LEADER SEVERE CONGESTION NASAL OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20120214 OTC MONOGRAPH FINAL part341 CARDINAL HEALTH OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 37205-337_b611845e-eef6-4519-ae3f-9a9702726000 37205-337 HUMAN OTC DRUG Peptic Relief Maximum Strength BISMUTH SUBSALICYLATE SUSPENSION ORAL 20090402 OTC MONOGRAPH FINAL part341 Leader BISMUTH SUBSALICYLATE 525 mg/15mL 37205-338_be672fce-9f95-44b1-a169-7931f257bbd9 37205-338 HUMAN OTC DRUG Anti-Itch Wal-Dryl Diphenhydramine HCl, Zinc Acetate SPRAY TOPICAL 20110802 OTC MONOGRAPH NOT FINAL part348 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 kg/100L; kg/100L 37205-339_3c5b53ff-23e7-4a88-bb2e-a80111e7e359 37205-339 HUMAN OTC DRUG Leader Premenstrual ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE CAPSULE ORAL 20120228 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 37205-341_771a5428-cbc1-4886-884a-a9f772ba43bc 37205-341 HUMAN OTC DRUG Leader Ibuprofen Ibuprofen TABLET, COATED ORAL 19900515 ANDA ANDA072096 Cardinal Health IBUPROFEN 200 mg/1 37205-344_e606ab2f-28af-48f7-ab95-bf697e2d9f00 37205-344 HUMAN OTC DRUG Leader Medicated TOLNAFTATE AEROSOL, POWDER TOPICAL 20080315 OTC MONOGRAPH FINAL part333C Cardinal Health Inc. TOLNAFTATE 10 mg/g 37205-345_d16da3c9-aaca-43a5-a572-3e99832ab68e 37205-345 HUMAN OTC DRUG Leader ibuprofen Ibuprofen TABLET, COATED ORAL 20060310 ANDA ANDA077349 Cardinal Health IBUPROFEN 200 mg/1 37205-346_fe6bc6f0-dfff-49a9-8251-43dfa0a48df2 37205-346 HUMAN OTC DRUG LEADER Loratadine loratadine TABLET ORAL 20030819 ANDA ANDA076134 Cardinal Health LORATADINE 10 mg/1 37205-348_3c4eaae3-d16a-455b-98de-9fc32853bdb5 37205-348 HUMAN OTC DRUG Leader Allergy Relief D-24 Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Cardinal Health LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 37205-349_c0b5f157-67c5-49f3-9f69-19df4c8d10cb 37205-349 HUMAN OTC DRUG Leader Stool Softener plus Stimulant Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20120301 OTC MONOGRAPH NOT FINAL part334 Cardinal Health DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 37205-350_0826599d-bd27-491e-bf26-4133e65e816e 37205-350 HUMAN OTC DRUG leader ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19900515 ANDA ANDA072096 Cardinal Health IBUPROFEN 200 mg/1 37205-356_c169a638-49b1-4b56-8b09-394805faede5 37205-356 HUMAN OTC DRUG Medicated Chest Rub JELLY TOPICAL 20110123 OTC MONOGRAPH FINAL part341 Cardinal Health CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100kg; kg/100kg 37205-358_36deb649-005e-4971-ab69-57dbba14b06c 37205-358 HUMAN OTC DRUG LEADER NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 Cardinal Health NICOTINE 21 mg/24h 37205-360_36f29de8-76d1-414f-b99f-940429120caa 37205-360 HUMAN OTC DRUG Leader ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090427 ANDA ANDA079113 Cardinal Health DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 37205-361_36deb649-005e-4971-ab69-57dbba14b06c 37205-361 HUMAN OTC DRUG LEADER NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 Cardinal Health NICOTINE 14 mg/24h 37205-362_44b54328-ab5e-4696-920d-853529498927 37205-362 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 19890621 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MAGNESIUM CITRATE 1.745 g/29.6mg 37205-363_36deb649-005e-4971-ab69-57dbba14b06c 37205-363 HUMAN OTC DRUG LEADER NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 Cardinal Health NICOTINE 7 mg/24h 37205-369_08bd717d-acf7-499e-b018-64b498330533 37205-369 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 CARDINAL HEALTH ASPIRIN 81 mg/1 37205-370_424e360e-c596-4476-b0f9-ccaf1d34bded 37205-370 HUMAN OTC DRUG Leader Anti Diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20030402 ANDA ANDA075232 Cardinal Health LOPERAMIDE HYDROCHLORIDE 2 mg/1 37205-372_1dee6273-cb24-44e8-bf3b-1e5d86416e72 37205-372 HUMAN OTC DRUG Leader Fiber Psyllium Husk CAPSULE ORAL 20110701 OTC MONOGRAPH NOT FINAL part334 Cardinal Health PSYLLIUM HUSK .52 g/1 37205-377_9b7fdde3-34a0-4a44-95db-1f5d3bc51d27 37205-377 HUMAN OTC DRUG Leader Anti Diarrheal Loperamide HCl SOLUTION ORAL 19971028 ANDA ANDA073243 Cardinal Health LOPERAMIDE HYDROCHLORIDE 1 mg/5mL 37205-378_87d86d5d-97cf-4e52-8eae-d077a6506ae4 37205-378 HUMAN OTC DRUG Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Cardinal Health LORATADINE 5 mg/5mL 37205-381_2db99c48-8632-4348-b33d-eda5db4b6488 37205-381 HUMAN OTC DRUG Leader Allergy Relief Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20040225 ANDA ANDA075990 Cardinal Health LORATADINE 10 mg/1 37205-387_368e5022-22d5-42ce-ba7d-c64d2b0f17d0 37205-387 HUMAN OTC DRUG Leader allergy relief Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20040225 ANDA ANDA075990 Cardinal Health LORATADINE 10 mg/1 37205-399_b6c844c4-4ba6-4827-8db8-5f3f5e99b0c2 37205-399 HUMAN OTC DRUG leader ibuprofen cold childrens Ibuprofen, Pseudoephedrine HCl SUSPENSION ORAL 20040325 ANDA ANDA076478 Cardinal Health IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100; 15 mg/5mL; mg/5mL 37205-402_019f2ddb-29cd-41b9-b7dd-7a96569febbf 37205-402 HUMAN OTC DRUG Leader Ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20040528 ANDA ANDA076359 Cardinal Health IBUPROFEN 100 mg/1 37205-405_ece7db10-e0ae-40e3-a4be-c1f03a9dbb38 37205-405 HUMAN OTC DRUG LEADER HEMORRHOIDAL MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL OINTMENT TOPICAL 20120501 OTC MONOGRAPH FINAL part346 CARDINAL HEALTH MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 140; 719; 2.5; 30 mg/g; mg/g; mg/g; mg/g 37205-429_a601225d-0bb0-467c-b742-41a7b808a5ee 37205-429 HUMAN OTC DRUG Leader Aspirin ASPIRIN TABLET, COATED ORAL 20120409 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ASPIRIN 325 mg/1 37205-436_c7a54077-eff5-4d36-8dab-5ef21d2e8237 37205-436 HUMAN OTC DRUG Leader Ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20040719 ANDA ANDA075217 Cardinal Health IBUPROFEN 50 mg/1.25mL 37205-445_13483408-70a6-4791-9dce-02f6f24c1d24 37205-445 HUMAN OTC DRUG leader nasal decongestant maximum strength Pseudoephedrine HCl TABLET, FILM COATED ORAL 19900615 OTC MONOGRAPH FINAL part341 Cardinal Health PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 37205-446_b46a956d-200b-42b9-b996-344d2950aea9 37205-446 HUMAN OTC DRUG Leader 12 Hour Nasal Decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19990721 ANDA ANDA075153 Cardinal Health PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 37205-457_3d11e5b3-e48c-44db-9ac9-2ead513b8983 37205-457 HUMAN OTC DRUG Earwax Removal Aid Earwax Removal Aid LIQUID AURICULAR (OTIC) 20120206 OTC MONOGRAPH FINAL part344 Cardinal Health CARBAMIDE PEROXIDE 6.5 mg/100mL 37205-458_cf66eb79-e208-439a-b2cd-444fe2025ce3 37205-458 HUMAN OTC DRUG Earwax Removal Kit Earwax Removal Kit LIQUID AURICULAR (OTIC) 20120206 OTC MONOGRAPH FINAL part344 Cardinal Health CARBAMIDE PEROXIDE 6.5 mg/100mL 37205-459_88dc17a3-ffbf-4063-891b-fd8083a9fdd9 37205-459 HUMAN OTC DRUG leader milk of magnesia Magnesium hydroxide LIQUID ORAL 20050119 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MAGNESIUM HYDROXIDE 1200 mg/15mL 37205-460_e6b5f41a-ae38-4a7a-809a-d4c810d1a7d0 37205-460 HUMAN OTC DRUG LEADER PAIN RELIEVING RUB ULTRA CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20120731 OTC MONOGRAPH NOT FINAL part348 CARDINAL HEALTH CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g 37205-466_788980a2-1879-4e9d-98a7-424667b2138a 37205-466 HUMAN OTC DRUG Leader Cough Tabs Guaifenesin TABLET ORAL 20050301 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN 200 mg/1 37205-467_8aec44d2-0134-4138-b3e0-dfaf256007ae 37205-467 HUMAN OTC DRUG leader aspirin Aspirin TABLET, CHEWABLE ORAL 19930809 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ASPIRIN 81 mg/1 37205-473_1a479976-afea-4770-ae68-affa14710d0d 37205-473 HUMAN OTC DRUG leader nasal decongestant pe maximum strength Phenylephrine Hydrochloride TABLET ORAL 20050504 OTC MONOGRAPH FINAL part341 Cardinal Health PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 37205-476_039aab42-4dab-48d4-a1d3-7f83ca9b51b4 37205-476 HUMAN OTC DRUG Leader Chest Congestion Relief G450 Guaifenesin TABLET ORAL 20050301 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN 400 mg/1 37205-477_6cac2800-03b0-4469-baaf-e47e018035de 37205-477 HUMAN OTC DRUG Leader 8 Hour Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Cardinal Health ACETAMINOPHEN 650 mg/1 37205-483_c2d6b968-f170-4052-8bf3-4aea48db92b1 37205-483 HUMAN OTC DRUG leader nose Phenylephrine hydrochloride LIQUID NASAL 20050706 OTC MONOGRAPH FINAL part341 Cardinal Health PHENYLEPHRINE HYDROCHLORIDE 1 mL/100mL 37205-488_5530eeaf-dae5-4a05-9a8b-e14b08bad035 37205-488 HUMAN OTC DRUG Pain Reliever Extra Strength (Leader) Acetaminophen TABLET ORAL 20090915 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 500 mg/1 37205-508_0c6f8ac7-0e29-4207-b338-fedada9610e6 37205-508 HUMAN OTC DRUG leader pain relief childrens Acetaminophen SUSPENSION ORAL 19970512 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL 37205-510_1475c678-d4d2-4642-9fbf-dd1ce2bad06e 37205-510 HUMAN OTC DRUG Leader Cardinal Health Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20010822 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ASPIRIN 81 mg/1 37205-516_d8aeda7a-636a-4d52-b26e-9dee7d2521df 37205-516 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050203 OTC MONOGRAPH NOT FINAL part343 CARDINAL HEALTH ACETAMINOPHEN 80 mg/1 37205-518_fc5ae70a-7a22-4f03-808c-0b84bd6f3aae 37205-518 HUMAN OTC DRUG leader childrens pain reliever Acetaminophen SUSPENSION ORAL 19900515 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL 37205-519_254e3136-d59e-4e3e-8ce3-6f2b996bbdab 37205-519 HUMAN OTC DRUG leader lice solution Piperonyl Butoxide, Pyrethrum Extract KIT 20071018 OTC MONOGRAPH FINAL part358G Cardinal Health 37205-519_2bb1f666-1864-45f5-9bfb-5ba9c7889f8d 37205-519 HUMAN OTC DRUG leader lice solution Piperonyl Butoxide, Pyrethrum Extract KIT 20071018 OTC MONOGRAPH FINAL part358G Cardinal Health 37205-530_8d4000ea-36e3-4cb8-9e75-96b97aafc3d4 37205-530 HUMAN OTC DRUG Leader Antacid Regular Strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19900415 OTC MONOGRAPH FINAL part332 Cardinal Health ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 37205-531_d0f044a3-bb3e-4bf9-9dde-70ca09ba0abd 37205-531 HUMAN OTC DRUG Leader Acid Control Acid Reducer Ranitidine TABLET ORAL 20090521 ANDA ANDA076760 Cardinal Health RANITIDINE HYDROCHLORIDE 75 mg/1 37205-535_d940a972-c41f-41a8-a858-6dd38c272965 37205-535 HUMAN OTC DRUG Leader Antacid Maximum Strength aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 19900515 OTC MONOGRAPH FINAL part331 Cardinal Health ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 37205-536_a14c3ed3-846a-4246-a4b5-d72166ae243a 37205-536 HUMAN OTC DRUG Leader Antacid Maximum Strength Aluminum Hydroxide, Magnesium Hydroxide, Simethicone LIQUID ORAL 20060123 OTC MONOGRAPH FINAL part332 Cardinal Health ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 37205-538_fcf14716-2b16-4d80-9ab3-e9a05bd9bef7 37205-538 HUMAN OTC DRUG Leader Chest Congestion Relief Plus DMDM DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20061220 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 37205-539_58e7d1e6-080c-4aa3-ad02-e93288db6007 37205-539 HUMAN OTC DRUG leader cold and allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20061122 OTC MONOGRAPH FINAL part341 Cardinal Health CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 37205-565_07ddc707-a51d-4ef9-afb2-3deadaef1027 37205-565 HUMAN OTC DRUG Leader Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 19900515 OTC MONOGRAPH FINAL part341 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 37205-570_5fe8e27a-ca58-48c1-ac51-468a24fa8b7e 37205-570 HUMAN OTC DRUG Leader Childrens Allergy Relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Cardinal Health LORATADINE 5 mg/5mL 37205-571_5506b5e9-53f0-42a0-9ed1-eff4e0081134 37205-571 HUMAN OTC DRUG leader sinus congestion and pain daytime non drowsy Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20070112 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 37205-575_7afdadc9-c364-465d-a965-81ad34e0b32e 37205-575 HUMAN OTC DRUG leader infants pain and fever Acetaminophen LIQUID ORAL 20120625 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL 37205-576_32163541-2a7f-4dc4-8796-735c2b002bc9 37205-576 HUMAN OTC DRUG Leader Pain and Fever Infants Acetaminophen SUSPENSION ORAL 20120815 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL 37205-577_c4290cab-6a3c-439b-8ea2-65e34d299110 37205-577 HUMAN OTC DRUG leader pain and fever acetaminophen LIQUID ORAL 20120625 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL 37205-581_356497f6-3447-4c65-9c81-6a78542a37e8 37205-581 HUMAN OTC DRUG Leader Sinus and Allergy PE Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20061019 OTC MONOGRAPH FINAL part341 Cardinal Health CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 37205-583_ee5df4e6-15af-4234-b49a-76b39e8b7965 37205-583 HUMAN OTC DRUG Miconazole 3 Combination Pack miconazole nitrate KIT VAGINAL 20021202 ANDA ANDA074926 Cardinal Health 37205-584_96930740-9827-4631-9608-63c7acd8fb8d 37205-584 HUMAN OTC DRUG Leader Loperamide Hydrochloride loperamide HCl LIQUID ORAL 20120328 ANDA ANDA091292 Cardinal Health LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 37205-585_f8c9acd3-cc9e-4b0a-8033-5bb9aba3f7ed 37205-585 HUMAN OTC DRUG leader hair regrowth treatment Minoxidil AEROSOL, FOAM TOPICAL 20120316 ANDA ANDA091344 Cardinal Health MINOXIDIL 5 g/100g 37205-586_44584f65-e0d9-4441-9235-2bc7d3430890 37205-586 HUMAN OTC DRUG leader nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20111130 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 37205-587_9e440cb2-2e19-4e20-b9ed-0cdb2b073fe0 37205-587 HUMAN OTC DRUG leader nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20111102 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 37205-589_7f289080-136d-47c5-89be-8cc1ef13b81e 37205-589 HUMAN OTC DRUG Miconazole 3 Combination Pack miconazole nitrate KIT VAGINAL 20010202 ANDA ANDA074926 CARDINAL HEALTH 37205-590_90f4c811-0f40-659f-f9f5-5c57a4ff74c2 37205-590 HUMAN OTC DRUG 7 DAY VAGINAL Miconazole Nitrate CREAM TOPICAL 20090316 OTC MONOGRAPH FINAL part333C Cardinal Health MICONAZOLE NITRATE 2 g/100g 37205-591_5f7f713f-89c8-40ac-b47c-30619ce0c05c 37205-591 HUMAN OTC DRUG Leader Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Cardinal Health CETIRIZINE HYDROCHLORIDE 1 mg/mL 37205-593_000d3eb3-b564-4793-97d8-da5757ff303f 37205-593 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen TABLET ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 CARDINAL HEALTH ACETAMINOPHEN 500 mg/1 37205-594_44a822c7-e835-4cc9-927a-81eff4246634 37205-594 HUMAN OTC DRUG Extra Strength Acetaminophen Acetaminophen TABLET ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 CARDINAL HEALTH ACETAMINOPHEN 500 mg/1 37205-595_aee860ab-851f-4abf-8d65-38e99c5a52a8 37205-595 HUMAN PRESCRIPTION DRUG ANTISEPTIC SKIN CLEANSER CHLORHEXIDINE GLUCONATE LIQUID TOPICAL 20120101 NDA NDA019125 Cardinal Health CHLORHEXIDINE GLUCONATE 4 mg/100mL Decreased Cell Wall Integrity [PE] 37205-602_622e9553-89d8-4fd4-87a8-5867de4a787f 37205-602 HUMAN OTC DRUG Epsom Salt MAGNESIUM SULFATE CRYSTAL ORAL; TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MAGNESIUM SULFATE 1.81 kg/100kg 37205-603_2e5705e8-ca97-48df-a06f-3e9c7bff189d 37205-603 HUMAN OTC DRUG LEADER DRY EYE RELIEF DEXTRAN, HYPROMELLOSE 2910 SOLUTION OPHTHALMIC 20120104 OTC MONOGRAPH FINAL part349 CARDINAL HEALTH DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S) .001; .003 mL/mL; mL/mL 37205-605_203e95e7-436c-4957-8b15-61766b6fea6f 37205-605 HUMAN OTC DRUG Leader ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19901015 ANDA ANDA077349 Cardinal Health IBUPROFEN 200 mg/1 37205-607_de03e285-4967-460e-8843-0b874dd1d203 37205-607 HUMAN OTC DRUG Leader Oral Pain Relief Anesthetic Benzocaine 20% GEL ORAL 20120808 OTC MONOGRAPH FINAL part356 Cardinal Health BENZOCAINE 200 mg/g 37205-610_c8774bd2-0b32-4545-ad0a-f2df8f85aab7 37205-610 HUMAN OTC DRUG LEADER iNTENSE COUGH RELIEVER Dextromethorphan Hydrobromide / Guaifenesin LIQUID ORAL 20110802 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 300 mg/5mL; mg/5mL 37205-612_1b7651e1-da29-4e5a-b1a7-ac855c419326 37205-612 HUMAN OTC DRUG Leader Clear Lax original prescription strength Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091026 ANDA ANDA090685 Cardinal Health POLYETHYLENE GLYCOL 3350 17 g/17g 37205-613_ee2d253f-7730-4e59-bc4a-af6f17a2ddad 37205-613 HUMAN OTC DRUG Burn Relief Leader Lidocaine SPRAY TOPICAL 20111201 OTC MONOGRAPH FINAL part348 Cardinal Health LIDOCAINE .05 g/100g 37205-614_47c3812f-08cb-48c1-8a26-2f0c06f58922 37205-614 HUMAN OTC DRUG leader acid reducer original strength Famotidine TABLET ORAL 20091014 ANDA ANDA075400 Cardinal Health FAMOTIDINE 10 mg/1 37205-615_9a947944-98d3-4c56-b43d-06271ced2400 37205-615 HUMAN OTC DRUG Ear Wax Removing Drops Carbamide Peroxide Leader LIQUID AURICULAR (OTIC) 20111201 OTC MONOGRAPH FINAL part344 Cardinal Health CARBAMIDE PEROXIDE 6.5 g/100mL 37205-616_217355e0-291c-4ebe-b7ef-edc1b8c113f0 37205-616 HUMAN OTC DRUG Ice External Analgesic Leader Menthol GEL TOPICAL 20111201 OTC MONOGRAPH FINAL part348 Cardinal Health MENTHOL .02 g/100g 37205-617_75302b1c-95f1-4bf9-a151-db8fb5bb45f3 37205-617 HUMAN OTC DRUG Ear Dry Leader Isopropyl Alcohol, Glycerin LIQUID AURICULAR (OTIC) 20111201 OTC MONOGRAPH FINAL part344 Cardinal Health GLYCERIN; ISOPROPYL ALCOHOL 5; 94.998 g/100mL; g/100mL 37205-625_eed56fc4-90b1-41c6-90b1-25ff694bd277 37205-625 HUMAN OTC DRUG Leader Medicated Wipes witch hazel SOLUTION TOPICAL 20100413 OTC MONOGRAPH FINAL part346 Cardinal Health WITCH HAZEL .5 mL/mL 37205-627_a7d7104e-2af7-425b-a7bc-b182d4b75023 37205-627 HUMAN OTC DRUG leader pain reliever childrens Acetaminophen SUSPENSION ORAL 20100303 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL 37205-628_c3e0c180-b33e-44c9-a501-fd8f85a27d07 37205-628 HUMAN OTC DRUG leader mucus er Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130319 ANDA ANDA078912 Cardinal Health GUAIFENESIN 600 mg/1 37205-629_4f6bb292-e596-4c97-bd5f-585ffba507d9 37205-629 HUMAN OTC DRUG Leader tussin dm max adult Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20100413 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 37205-630_87e1c262-9d7b-4fbc-93be-6d527827441e 37205-630 HUMAN OTC DRUG LEADER MAXIMUM STRENGHT URINARY PAIN RELIEF PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20090430 UNAPPROVED DRUG OTHER Cardinal Health PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 37205-635_96d1f8d8-ae7c-4ae8-829c-051867be4c79 37205-635 HUMAN OTC DRUG LEADER LUBRICATING EYE DROP CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN SOLUTION OPHTHALMIC 20120104 OTC MONOGRAPH FINAL part349 CARDINAL HEALTH CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL 37205-636_efc2f3b1-c5bd-46d5-976e-9db7922aaef7 37205-636 HUMAN OTC DRUG LEADER LUBRICANT EYE DROPS POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL SOLUTION OPHTHALMIC 20120104 OTC MONOGRAPH FINAL part349 CARDINAL HEALTH POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mL/mL; mL/mL 37205-637_ce7fbf6d-00e7-4f6d-92f5-9ea5e091e724 37205-637 HUMAN OTC DRUG LEADER DIAPER RASH ZINC OXIDE OINTMENT TOPICAL 20120120 OTC MONOGRAPH FINAL part347 CARDINAL HEALTH ZINC OXIDE .4 g/g 37205-638_6c6e217b-95e7-4351-9cb6-39952e7a6210 37205-638 HUMAN OTC DRUG Leader Allergy Eye Ketotifen SOLUTION OPHTHALMIC 20100922 ANDA ANDA077958 Cardinal Health KETOTIFEN FUMARATE .25 mg/mL 37205-640_79d07fce-8159-4daa-8b99-419123e63196 37205-640 HUMAN OTC DRUG leader miconazole 1 Miconazole nitrate KIT 20110119 ANDA ANDA079114 Cardinal Health 37205-641_9e5604b2-fb26-4725-9c93-66ba917eecd6 37205-641 HUMAN OTC DRUG LEADER CAPSAICIN CAPSAICIN CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 CARDINAL HEALTH CAPSAICIN .1 g/100g 37205-643_a087bae0-ded6-4b4d-8a4d-c87f0ae43508 37205-643 HUMAN OTC DRUG Leader Ibuprofen Ibuprofen SUSPENSION ORAL 19990128 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL 37205-646_a245c0ce-4693-4cc2-b7f4-2f89d3b243e7 37205-646 HUMAN OTC DRUG Leader Ibuprofen Infants ibuprofen SUSPENSION ORAL 19990930 ANDA ANDA075217 Cardinal Health IBUPROFEN 50 mg/1.25mL 37205-648_efb30a1a-7300-40ed-83dc-5eab2b363b73 37205-648 HUMAN OTC DRUG Decolorized Iodine Ethyl Alcohol LIQUID TOPICAL 19790101 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ALCOHOL .45 mL/mL 37205-650_094465af-c28c-444d-a633-dee6afc73d7d 37205-650 HUMAN OTC DRUG leader aller ease fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110516 ANDA ANDA076447 Cardinal Health FEXOFENADINE HYDROCHLORIDE 180 mg/1 37205-653_caeacf73-1f2f-48e1-a8c3-0525a46b560b 37205-653 HUMAN OTC DRUG Leader Medicated Miconazole nitrate POWDER TOPICAL 20101031 OTC MONOGRAPH FINAL part333C Cardinal Health Inc. MICONAZOLE NITRATE 1.42 g/71g 37205-656_af42c273-7b79-4c29-844f-a4a904cb98dd 37205-656 HUMAN OTC DRUG leader nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20120411 ANDA ANDA078547 Cardinal Health NICOTINE 2 mg/1 37205-657_eda942e1-b60e-4ee5-8a90-7e672a53784e 37205-657 HUMAN OTC DRUG leader nicotine Nicotine polacrilex GUM, CHEWING ORAL 20120418 ANDA ANDA078546 Cardinal Health NICOTINE 4 mg/1 37205-659_c7e42277-822a-49d6-89b0-7fde7e3980b4 37205-659 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen TABLET ORAL 19930121 OTC MONOGRAPH NOT FINAL part343 CARDINAL HEALTH ACETAMINOPHEN 500 mg/1 37205-660_75431172-3716-47a5-8191-ab58ebc75c00 37205-660 HUMAN OTC DRUG Leader ibuprofen Ibuprofen SUSPENSION ORAL 20020425 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL 37205-661_1db3bc13-7858-465b-a0dc-9aac2ebabfbf 37205-661 HUMAN OTC DRUG Leader Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120530 ANDA ANDA202319 Cardinal Health LANSOPRAZOLE 15 mg/1 37205-662_bc9938dd-9ee4-49c2-a80e-bc90d0ca6646 37205-662 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, EXTENDED RELEASE ORAL 20121221 ANDA ANDA078569 Cardinal Health ACETAMINOPHEN 650 mg/1 37205-664_07ce0282-64a7-4732-9de7-7d857cd5062d 37205-664 HUMAN OTC DRUG Antiseptic Mouth Rinse MOUTHWASH ORAL 19970615 OTC MONOGRAPH NOT FINAL part356 Cardinal Health EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 mL/100L; mL/100L; mL/100L; mL/100L 37205-665_80593224-fcaf-4063-a655-dcb0df64f63e 37205-665 HUMAN OTC DRUG Leader Natural Fiber Psyllium Husk POWDER ORAL 20120701 OTC MONOGRAPH NOT FINAL part334 Cardinal Health PSYLLIUM HUSK 3.4 g/5.8g 37205-666_29e631b1-c71b-42f5-bc5a-c329a453d91e 37205-666 HUMAN OTC DRUG Leader Natural Fiber Psyllium Husk POWDER ORAL 20120701 OTC MONOGRAPH NOT FINAL part334 Cardinal Health PSYLLIUM HUSK 3.4 g/5.8g 37205-667_32e16af2-5b8e-4c96-b5a0-7ec0e2b2d7ac 37205-667 HUMAN OTC DRUG Leader Natural Fiber Psyllium Husk POWDER ORAL 20120701 OTC MONOGRAPH NOT FINAL part334 Cardinal Health PSYLLIUM HUSK 3.4 g/5.8g 37205-668_5a9f7db6-d7b4-415f-a443-baea20050e69 37205-668 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20060210 OTC MONOGRAPH FINAL part343 CARDINAL HEALTH ASPIRIN 325 mg/1 37205-670_6fc18b72-2840-477c-89a1-8bce5ec1f6c9 37205-670 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 CARDINAL HEALTH IBUPROFEN 200 mg/1 37205-671_372c6cc0-51e5-4ede-aed6-325072b93aac 37205-671 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 CARDINAL HEALTH DOXYLAMINE SUCCINATE 25 mg/1 37205-672_8ed76376-ca12-4a72-a047-dac9be323872 37205-672 HUMAN OTC DRUG leader ibuprofen pm Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20120613 ANDA ANDA079113 Cardinal Health DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 37205-674_56d3eb7a-5a8c-4cf3-acef-9204fb674617 37205-674 HUMAN OTC DRUG Leader TabTussin 400 Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN 400 mg/1 37205-674_d7dcac42-60c8-4d7e-b547-fec1f5507854 37205-674 HUMAN OTC DRUG Leader TabTussin 400 Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN 400 mg/1 37205-675_fe8524f9-e17b-4a00-9fed-7fae48734deb 37205-675 HUMAN OTC DRUG Leader TabTussin DM TDM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 37205-676_e404f1ec-2711-4482-b50c-32693a0b60ae 37205-676 HUMAN OTC DRUG leader childrens pain and fever Acetaminophen SUSPENSION ORAL 20120717 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL 37205-677_0d12b944-f895-4233-9bd8-51a974c73798 37205-677 HUMAN OTC DRUG leader headache pm formula Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120625 OTC MONOGRAPH FINAL part338 Cardinal Health ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 37205-678_8b0489e4-171c-4c17-a062-b2ad54c2b601 37205-678 HUMAN OTC DRUG leader flu and severe cold and cough Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20120613 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 37205-679_3e1e350e-0797-4d08-aef9-aed939b9ac16 37205-679 HUMAN OTC DRUG leader flu and severe cold and cough Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20120613 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 37205-680_3d519f54-6bb8-497d-a614-1e675631ba5c 37205-680 HUMAN OTC DRUG leader acid reducer complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20120426 ANDA ANDA077355 Cardinal Health CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 37205-681_620e2d42-d883-4bf0-bf3b-66ddd1b2839c 37205-681 HUMAN OTC DRUG leader acid reducer complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20120502 ANDA ANDA077355 Cardinal Health CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 37205-682_ec4a8a5a-f1c9-4d33-af9c-2bdd0cfcc89f 37205-682 HUMAN OTC DRUG Leader Acid Control Ranitidine TABLET, FILM COATED ORAL 20111111 ANDA ANDA091429 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 37205-683_1e9baf1a-c0aa-44b8-b0af-0ac531c9c529 37205-683 HUMAN OTC DRUG Anti-Itch Men-Phor LOTION TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part356 CARDINAL HEALTH CAMPHOR (SYNTHETIC); MENTHOL .5; .5 g/g; g/g 37205-684_caed4b9c-2730-4c76-b6bf-33d534c64282 37205-684 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Cardinal Health PYRITHIONE ZINC 1 kg/100L 37205-686_02c0fdcf-3b4e-4681-be4a-fb886a839797 37205-686 HUMAN OTC DRUG leader tussin dextromethorphan hbr, guaifenesin LIQUID ORAL 20120813 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/5mL; mg/5mL 37205-692_b0356d7d-86de-4d8f-beaf-6b5ffc68ab51 37205-692 HUMAN OTC DRUG Leader Cherry SPF 4 Lip Balm Padimate O, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH FINAL part352 Cardinal Health (Leader) PADIMATE O; PETROLATUM 1.5; 44 mg/g; mg/g 37205-693_2d25b07b-1e0a-4960-8c00-a40f0b9c7070 37205-693 HUMAN OTC DRUG Leader Moisture SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Cardinal Health (Leader) OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 40.7 mg/g; mg/g; mg/g 37205-694_1ee52c1a-6295-4ff4-ab70-035b96325c0d 37205-694 HUMAN OTC DRUG Leader Original SPF 4 Lip Balm Padimate O, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Cardinal Health (Leader) PADIMATE O; PETROLATUM 1.5; 44 mg/g; mg/g 37205-695_ee391680-3831-417f-b1e9-a945153052db 37205-695 HUMAN OTC DRUG leader nite time cough Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20130428 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 37205-696_5fecf3bb-f5ed-48f6-ac4c-ae7207d242a5 37205-696 HUMAN OTC DRUG leader tussin cf max dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20121226 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL 37205-697_067f9b5e-0595-47d9-81da-197575300fda 37205-697 HUMAN OTC DRUG leader cough dm dextromethorphan polistirex SUSPENSION ORAL 20120913 ANDA ANDA091135 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 37205-698_3fcf2942-ef1a-429c-8cd3-09dd3ef25e38 37205-698 HUMAN OTC DRUG leader cough dm dextromethorphan polistirex SUSPENSION ORAL 20130604 ANDA ANDA091135 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 37205-703_f504985c-f11a-4959-8d33-445bc154752f 37205-703 HUMAN OTC DRUG leader headache formula added strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19970402 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 37205-705_52288d33-3bc5-4d0f-95da-6c28e11df417 37205-705 HUMAN OTC DRUG Leader Day Time Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20061006 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 37205-706_ffcb6e47-62d3-4eed-9f2d-386b7ec3b5a0 37205-706 HUMAN OTC DRUG leader antacid Calcium carbonate TABLET, CHEWABLE ORAL 19970529 OTC MONOGRAPH FINAL part331 Cardinal Health CALCIUM CARBONATE 750 mg/1 37205-707_13e552a4-3eb3-401e-94be-825daca5a457 37205-707 HUMAN OTC DRUG Leader Nite Time Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20060629 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 37205-708_202f3fbe-8609-450d-be9b-10dc1781b2b8 37205-708 HUMAN OTC DRUG leader aspirin Aspirin TABLET, CHEWABLE ORAL 19970402 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ASPIRIN 81 mg/1 37205-709_a4318278-8e3b-4902-b068-b047195c5848 37205-709 HUMAN OTC DRUG leader tussin cf Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20060425 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 37205-711_e0db8fda-b4d9-412c-842e-f2dd99fab6ad 37205-711 HUMAN OTC DRUG Leader Pain Reliever Acetaminophen TABLET, COATED ORAL 20060516 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 500 mg/1 37205-712_3ce5f59d-d32f-41b5-93b7-2011770d229e 37205-712 HUMAN OTC DRUG Leader Adult Tussin DM Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19970605 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 37205-715_f0805ebc-17e6-3c36-34ca-f4fa92c7e9e2 37205-715 HUMAN OTC DRUG LEADER HEMORRHOIDAL Phenylephrine Hydrochloride, Hard Fat SUPPOSITORY RECTAL 20090312 OTC MONOGRAPH FINAL part346 CARDINAL HEALTH, INC. FAT, HARD; PHENYLEPHRINE HYDROCHLORIDE 1881; 5.77 mg/1; mg/1 37205-717_e21e12b4-8f70-474b-a37f-f72e162ec084 37205-717 HUMAN OTC DRUG leader pain reliever childrens Acetaminophen SUSPENSION ORAL 19970622 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL 37205-719_2bccf3e1-b70b-45da-816d-842037c18016 37205-719 HUMAN OTC DRUG leader day time multi symptom cold flu relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20060801 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 37205-720_3ec91a1a-e27a-46b4-85c1-c8e925d85216 37205-720 HUMAN OTC DRUG Leader Stomach Relief original strength Bismuth subsalicylate TABLET, CHEWABLE ORAL 19971007 OTC MONOGRAPH FINAL part335 Cardinal Health BISMUTH SUBSALICYLATE 262 mg/1 37205-721_db355bf4-74f1-40d4-9159-9cd3d4429787 37205-721 HUMAN OTC DRUG Leader Baby Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 57.5; 72.1; 41.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 37205-722_1298fda2-c7f7-472a-854a-f39162b03e56 37205-722 HUMAN OTC DRUG Leader Dark Tanning SPF 4 Octinoxate, Oxybenzone AEROSOL, SPRAY TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health OCTINOXATE; OXYBENZONE 16.6; 4.15 mg/mL; mg/mL 37205-723_9fbea52c-d538-4e79-b738-ed47b912a370 37205-723 HUMAN OTC DRUG Leader Kids SPF 50 Sunscreen Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone AEROSOL, SPRAY TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 37205-724_8c747897-d450-43db-a9b5-1e8a99673c2d 37205-724 HUMAN OTC DRUG Leader Kids SPF 90 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27.75; 138.75; 46.25; 92.5; 55.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 37205-725_3258194e-53b9-4ae5-a2b8-7bc5d3b7525f 37205-725 HUMAN OTC DRUG Leader Sport Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.6; 132.6; 51; 51; 61.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 37205-726_1fa8b699-a01c-409d-b93d-a9e549e9f4b9 37205-726 HUMAN OTC DRUG Leader Sport SPF 30 Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone AEROSOL, SPRAY TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.1; 87; 43.5; 17.4; 34.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 37205-727_9fc8c582-5633-459b-b16a-40e2452f6cad 37205-727 HUMAN OTC DRUG Leader Sport SPF 50 Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone AEROSOL, SPRAY TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.5; 85; 42.5; 34; 42.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 37205-728_1512bc8e-7e53-40c4-af51-994117c5ff83 37205-728 HUMAN OTC DRUG Leader General Protection Sunscreen SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20.4; 107.1; 51; 20.4; 20.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 37205-729_46090fb4-9718-4667-89cb-7f0a98023ecb 37205-729 HUMAN OTC DRUG Leader General Protection Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.6; 132.6; 51; 71.4; 40.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 37205-730_5be4dce8-c477-43cb-ad3f-2e7243e6d69e 37205-730 HUMAN OTC DRUG Leader GP SPF 15 CS Homosalate, Octisalate, Oxybenzone, Avobenzone AEROSOL, SPRAY TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 17.4; 87; 43.5; 26.1 mg/mL; mg/mL; mg/mL; mg/mL 37205-731_5e83707e-f5c4-438f-bf51-a31a4dc5cd67 37205-731 HUMAN OTC DRUG Leader General Protection SPF 30 Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone AEROSOL, SPRAY TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.1; 87; 43.5; 17.4; 34.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 37205-732_eb22c509-169c-4007-a2e2-a269c7fa3ac3 37205-732 HUMAN OTC DRUG Leader General Protection SPF 70 Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone AEROSOL, SPRAY TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.1; 130.5; 43.5; 87; 57.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 37205-733_23da822f-e315-4943-b807-32025debec62 37205-733 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20121109 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ALCOHOL 70 mL/100mL 37205-734_f2034847-1e95-4654-98e1-9c630707faa2 37205-734 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20121109 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ALCOHOL 700 mL/100mL 37205-735_8e61b7f5-7998-41db-b8dd-51c1608d84dc 37205-735 HUMAN OTC DRUG LEADER ORIGINAL NASAL OXYMETAZOLINE HYDROCHOLORIDE SPRAY NASAL 20120930 OTC MONOGRAPH FINAL part341 CARDINAL HEALTH OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 37205-736_32779c3a-17a5-4076-8cf4-76bb4531c242 37205-736 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20121211 ANDA ANDA078682 Cardinal Health (Leader) IBUPROFEN 200 mg/1 37205-738_a331ddc4-6c0d-49eb-aef0-97a94dfb58b8 37205-738 HUMAN OTC DRUG Maximum Strength Menstrual Complete Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 CARDINAL HEALTH ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 37205-739_57f63e2c-928d-4a0c-8708-bc3cafdfb62b 37205-739 HUMAN OTC DRUG LEADER MEDICATED PADS WITCH HAZEL SOLUTION TOPICAL 20120401 OTC MONOGRAPH FINAL part346 CARDINAL HEALTH WITCH HAZEL .5 mL/mL 37205-741_3bef5f79-1f57-4492-89df-71d1aead8fbb 37205-741 HUMAN OTC DRUG LEADER MEDICATED WIPE WITCH HAZEL SOLUTION TOPICAL 20120301 OTC MONOGRAPH FINAL part346 CARDINAL HEALTH WITCH HAZEL 5 g/1 37205-742_6e4d603d-f170-49a8-9cea-987f83a6c63c 37205-742 HUMAN OTC DRUG Allergy Antihistamine Diphenhydramine HCl CAPSULE ORAL 20120830 OTC MONOGRAPH FINAL part336 Cardinal Health (Leader) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 37205-743_b0c8adb3-99e1-4f22-936d-b280ddce871a 37205-743 HUMAN OTC DRUG Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20121030 OTC MONOGRAPH FINAL part336 Cardinal Health (Leader) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 37205-744_9d9889c0-5f16-49d0-a37b-ad1402f272aa 37205-744 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20120830 ANDA ANDA079096 Cardinal Health (Leader) NAPROXEN SODIUM 220 mg/1 37205-745_7cafc926-850f-4d74-bd87-f5e45bc29600 37205-745 HUMAN OTC DRUG Allergy Relief Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Cardinal Health LORATADINE 10 mg/1 37205-750_c1a7774c-d565-4bc4-a2c9-023789ac01b1 37205-750 HUMAN OTC DRUG Arthritis Leader Trolamine Salicylate CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part348 Cardinal Health TROLAMINE SALICYLATE 10 g/100g 37205-751_7c55f702-e86e-4dd5-9624-e636fc1c1526 37205-751 HUMAN OTC DRUG Leader Camphor Phenol Gel Camphor, Phenol GEL TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part348 Cardinal Health (Leader) CAMPHOR (SYNTHETIC); PHENOL 10.8; 4.7 mg/g; mg/g 37205-752_f0cd0e37-32dd-4baf-902b-e26f1c4d0164 37205-752 HUMAN OTC DRUG Kettle Neti Pot SODIUM BICARBONATE, SODIUM CHLORIDE POWDER, FOR SOLUTION ORAL 20130401 UNAPPROVED DRUG OTHER Cardinal Health 414, LLC SODIUM BICARBONATE; SODIUM CHLORIDE 700; 2300 mg/1; mg/1 37205-753_a29d6d05-a22d-4eca-9e2c-e791d89e9655 37205-753 HUMAN OTC DRUG Saline Refills SODIUM BICARBONATE, SODIUM CHLORIDE POWDER, FOR SOLUTION ORAL 20130401 UNAPPROVED DRUG OTHER Cardinal Health 414, LLC SODIUM BICARBONATE; SODIUM CHLORIDE 2300; 700 mg/1; mg/1 37205-754_dad9f0d7-b215-4c62-a81b-bf59f5588e7f 37205-754 HUMAN OTC DRUG Leader Enema Saline ENEMA RECTAL 20130219 OTC MONOGRAPH NOT FINAL part334 CARDINAL HEALTH, INC. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 37205-755_844f685d-c5c6-4058-897f-84213130bcd5 37205-755 HUMAN OTC DRUG Leader Enema Mineral Oil ENEMA RECTAL 20130219 OTC MONOGRAPH NOT FINAL part334 CARDINAL HEALTH, INC. MINERAL OIL 118 mL/118mL 37205-756_559fdfe5-a96d-4d38-81dd-a62da941505d 37205-756 HUMAN OTC DRUG Cold Head Congestion Daytime Non-Drowsy Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050715 OTC MONOGRAPH FINAL part341 CARDINAL HEALTH ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 37205-757_796b68f7-b119-4b36-92ce-6692b76efae3 37205-757 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130413 OTC MONOGRAPH FINAL part343 Cardinal Health (Leader) ASPIRIN 81 mg/1 37205-759_edef3a9f-b205-40af-9acc-6cee7fc8ded8 37205-759 HUMAN OTC DRUG Extra Strength Pain Reliever PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 CARDINAL HEALTH ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 37205-760_62595650-8479-413d-a631-29d56f40caad 37205-760 HUMAN OTC DRUG Leader Clotrimazole Anti-Fungal CLOTRIMAZOLE CREAM TOPICAL 20130531 OTC MONOGRAPH FINAL part333C Cardinal Health CLOTRIMAZOLE 1 g/100g 37205-762_8844fb91-be91-4945-8107-bf1cd6a0e774 37205-762 HUMAN OTC DRUG leader lubricant eye Polyethylene glycol, Propylene glycol SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130510 OTC MONOGRAPH FINAL part349 Cardinal Health POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 g/100mL; g/100mL 37205-763_07834073-f3c8-4f7a-89ad-17e88aaa5a26 37205-763 HUMAN OTC DRUG Leader Lubricating plus carboxymethylcellulose sodium SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130510 OTC MONOGRAPH FINAL part349 Cardinal Health CARBOXYMETHYLCELLULOSE SODIUM .5 g/100mL 37205-779_21b545c2-b217-4aa9-9aa5-525492a32f35 37205-779 HUMAN OTC DRUG Leader Nite Time Cold Flu Relief Multi Symptom acetaminophen, dextromethorphan hydrobromide, doxylamine succinate LIQUID ORAL 20060620 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 37205-780_a8b02ad9-ba8c-47a4-980e-97a389e47024 37205-780 HUMAN OTC DRUG leader Antacid Extra Strength Aluminum hydroxide, Magnesium carbonate TABLET, CHEWABLE ORAL 19961023 OTC MONOGRAPH FINAL part331 Cardinal Health ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 37205-781_1c3cb00b-e5cc-496b-8019-b66acc56ac9d 37205-781 HUMAN OTC DRUG Leader nite time multi symptom cold flu relief acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20060629 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 37205-819_7c761d3b-3499-44f9-902e-5768606f547f 37205-819 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20130303 NDA NDA022429 Cardinal Health (Leader) 37205 CETIRIZINE HYDROCHLORIDE 10 mg/1 37205-820_c69e021b-e6d3-4e71-9208-0d981b58e724 37205-820 HUMAN OTC DRUG LEADER ALL DAY ALLERGY cetirizine TABLET ORAL 20071227 ANDA ANDA077498 Cardinal Health CETIRIZINE HYDROCHLORIDE 10 mg/1 37205-822_a78800b9-81d7-46fd-b8ab-c40a6b914779 37205-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 20120515 OTC MONOGRAPH FINAL part347 Cardinal Health WITCH HAZEL .86 mL/100L 37205-824_bc4890f8-4935-42f1-9125-652c90c5d5ee 37205-824 HUMAN OTC DRUG Pain Relieving MENTHOL GEL TOPICAL 20120118 OTC MONOGRAPH FINAL part348 Cardinal Health MENTHOL 3.5 mL/100mL 37205-825_9e0e3a59-3dfb-4675-aa9c-92bc1aeea5c1 37205-825 HUMAN OTC DRUG Leader All Day Allergy Cetirizine Hydrochloride TABLET ORAL 20080116 ANDA ANDA078336 Cardinal Health CETIRIZINE HYDROCHLORIDE 10 mg/1 37205-826_62e795b9-af6c-4847-a0de-3e4d29e67c90 37205-826 HUMAN OTC DRUG Childrens All Day Allergy (Leader) cetirizine hydrochloride LIQUID ORAL 20090929 ANDA ANDA090254 Cardinal Health CETIRIZINE HYDROCHLORIDE 5 mg/5mL 37205-827_feb9da06-3aab-4242-aba5-42ff2d989769 37205-827 HUMAN OTC DRUG Leader Allergy D 12 Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080514 ANDA ANDA077170 Cardinal Health CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 37205-828_01461ee1-0ed5-41a7-948e-b15b12b1b133 37205-828 HUMAN OTC DRUG leader cold head congestion Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20080221 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 37205-831_d03d25c1-1ed0-406e-8ed1-9ce9f87e2ada 37205-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL 19890621 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MINERAL OIL 1 mL/100L 37205-833_abf3b529-d851-4ee5-ab58-1f1d2c3f5159 37205-833 HUMAN OTC DRUG Leader Milk of Magnesia Magnesium hydroxide LIQUID ORAL 19921201 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MAGNESIUM HYDROXIDE 1200 mg/15mL 37205-834_364a0bc7-3228-489e-af62-94358b8d9000 37205-834 HUMAN OTC DRUG leader milk of magnesia saline laxative Magnesium hydroxide LIQUID ORAL 19971021 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MAGNESIUM HYDROXIDE 1200 mg/15mL 37205-837_ac938614-416f-4a91-b3ec-87dcd6cb21a4 37205-837 HUMAN OTC DRUG leader omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080228 NDA NDA022032 Cardinal Health OMEPRAZOLE 20 mg/1 37205-844_7faab9ce-49d6-4e4c-a075-e1146edded24 37205-844 HUMAN OTC DRUG Leader Acid Control Maximum Strength Ranitidine TABLET ORAL 20080220 ANDA ANDA078653 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 37205-845_a20da7d3-3ab8-4944-8798-ec0e3bd4b1e3 37205-845 HUMAN OTC DRUG leader acid control Ranitidine TABLET, FILM COATED ORAL 20111111 ANDA ANDA091429 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 37205-848_e0ef7cce-7942-4648-9300-942f7b840065 37205-848 HUMAN OTC DRUG leader ibuprofen Ibuprofen LIQUID ORAL 20081016 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL 37205-850_fe4ea89f-0011-444e-bc52-aa2e78181ef8 37205-850 HUMAN OTC DRUG leader night time cough and cold childrens triacting Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20080724 OTC MONOGRAPH FINAL part341 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 37205-851_db8cb908-1ccd-4d6a-8273-229bc1717956 37205-851 HUMAN OTC DRUG leader nite time multi symptom cold and flu relief acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid LIQUID ORAL 20091005 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 37205-852_ce54a65b-2913-450f-b7af-b23c54fbb742 37205-852 HUMAN OTC DRUG Leader ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 19901115 ANDA ANDA076359 Cardinal Health IBUPROFEN 100 mg/1 37205-854_efcd3aa6-29c1-4fb5-9a2f-9fbf174d66c1 37205-854 HUMAN OTC DRUG Leader Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20101201 NDA NDA021920 Cardinal Health NAPROXEN SODIUM 220 mg/1 37205-855_ca9b657c-b301-4d13-b1bb-53ee3c647e73 37205-855 HUMAN OTC DRUG leader childrens all day allergy cetirizine Hydrochloride LIQUID ORAL 20101109 ANDA ANDA090254 Cardinal Health CETIRIZINE HYDROCHLORIDE 5 mg/5mL 37205-856_e432aba5-e256-48b4-a14b-a21dd2c80fda 37205-856 HUMAN OTC DRUG leader nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120725 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 37205-861_d31e64b4-e797-49ea-b3f7-c21cfd62c676 37205-861 HUMAN OTC DRUG Leader Acid Reducer Maximum Strength Famotidine TABLET ORAL 20061102 ANDA ANDA077351 Cardinal Health FAMOTIDINE 20 mg/1 37205-871_f730e5de-cba1-4c1b-867d-96463e5d87e5 37205-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LOTION TOPICAL 20120512 OTC MONOGRAPH NOT FINAL part333A Cardinal Health HYDROGEN PEROXIDE 3 kg/100L 37205-874_d03c3837-4d31-4ef2-9cf8-4cf6456544ee 37205-874 HUMAN OTC DRUG LEADER Chest Congestion Relief PE Guaifenesin/phenylephrine TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 37205-931_bcc8a46c-ba10-4e08-a7ed-d06b4f016847 37205-931 HUMAN OTC DRUG Leader Childrens Cold and Allergy phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20061030 OTC MONOGRAPH FINAL part341 Cardinal Health BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 37205-940_a2a9d539-91d6-4afa-a524-eed2de9714e4 37205-940 HUMAN OTC DRUG leader allergy multi symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20060118 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 37205-941_f129e1a4-b206-416e-8469-9bc2b11f9ec3 37205-941 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Cardinal Health TERBINAFINE HYDROCHLORIDE 1 g/100g 37205-951_ef71911d-0460-441e-9a9a-7c32f06304a6 37205-951 HUMAN OTC DRUG leader stomach relief Bismuth subsalicylate LIQUID ORAL 19900415 OTC MONOGRAPH FINAL part335 Cardinal Health BISMUTH SUBSALICYLATE 262 mg/15mL 37205-952_d2d357fe-3a15-4ca6-a9e7-7d6f158e14b3 37205-952 HUMAN OTC DRUG leader stomach relief Bismuth subsalicylate LIQUID ORAL 19941109 OTC MONOGRAPH FINAL part335 Cardinal Health BISMUTH SUBSALICYLATE 525 mg/15mL 37205-958_67e876aa-43f2-4154-8cbd-cb8d80c93a81 37205-958 HUMAN OTC DRUG leader cold head congestion Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20071115 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 37205-959_e36bae47-3e36-4689-beed-07e46d7c9d6e 37205-959 HUMAN OTC DRUG Leader Cold Head Congestion Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070419 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 37205-960_ac6f7da8-879b-47da-bb95-229cc828d16c 37205-960 HUMAN OTC DRUG Leader Adult Tussin Chest Congestion Guaifenesin SYRUP ORAL 19900415 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN 100 mg/5mL 37205-967_6d64c836-cb5c-41da-8918-4e1fa7c21677 37205-967 HUMAN OTC DRUG Leader Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070104 ANDA ANDA076777 Cardinal Health NICOTINE 2 mg/1 37205-968_e4e36b54-6bb9-417f-865a-e5646f8486e5 37205-968 HUMAN OTC DRUG Leader Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070104 ANDA ANDA076779 Cardinal Health NICOTINE 4 mg/1 37205-969_163d504f-f028-4b47-ae96-a3cb34af288e 37205-969 HUMAN OTC DRUG Leader Childrens Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20070426 OTC MONOGRAPH FINAL part343 Cardinal Health BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 37205-970_6f930de3-c8bc-4915-a303-3a5a43d4da21 37205-970 HUMAN OTC DRUG leader tussin dm Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 19911021 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 37205-973_2c541b4c-22b3-4960-8b76-03c2cc6fc490 37205-973 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20070320 OTC MONOGRAPH NOT FINAL part333A Cardinal Health BENZALKONIUM CHLORIDE .13 mL/mL 37205-976_64e6962b-22df-49bc-a245-052b1031fb98 37205-976 HUMAN OTC DRUG Ethyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120510 OTC MONOGRAPH FINAL part333A Cardinal Health ISOPROPYL ALCOHOL .7 L/100L 37205-977_811131c6-0c21-42ac-bd4f-063ec337ebe1 37205-977 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120512 OTC MONOGRAPH FINAL part333A Cardinal Health ISOPROPYL ALCOHOL .7 L/100L 37205-980_179a45c2-e1c5-4a15-a968-6868cad8c21c 37205-980 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 CARDINAL HEALTH ACETAMINOPHEN 500 mg/1 37205-987_be7b42d7-5c59-481a-af42-b079eede19aa 37205-987 HUMAN OTC DRUG leader nicotine Nicotine Polacrilex LOZENGE ORAL 20071005 ANDA ANDA077007 Cardinal Health NICOTINE 2 mg/1 37205-988_21410511-6aaf-4c8c-ae9f-bce7713ca0ca 37205-988 HUMAN OTC DRUG leader nicotine Nicotine Polacrilex LOZENGE ORAL 20071005 ANDA ANDA077007 Cardinal Health NICOTINE 4 mg/1 37205-989_208929dd-eab8-47fd-93f8-9ff512c87f15 37205-989 HUMAN OTC DRUG Alcohol Swab with Benzocaine benzocaine SWAB TOPICAL 20070701 OTC MONOGRAPH NOT FINAL part348 Cardinal Health BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 37205-992_2cf666d1-fd63-4a8d-a3eb-d0aa8765ff41 37205-992 HUMAN OTC DRUG leader mucus relief childrens Guaifenesin LIQUID ORAL 20071026 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN 100 mg/5mL 37205-993_a7ca2a94-b462-4836-8565-30caaadfec66 37205-993 HUMAN OTC DRUG Leader Childrens Mucus Relief Cough Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20071011 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 37205-994_fb3a5696-f0ed-47bf-8ee0-10daf43459a4 37205-994 HUMAN OTC DRUG Leader Day time Cough and Cold Childrens Dextromethorphan HBr, Phenylephrine HCl SYRUP ORAL 20070913 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 37205-998_764c15e2-1f06-4d3c-a177-8d26e86ae7ad 37205-998 HUMAN OTC DRUG Leader Medicated Miconazole nitrate AEROSOL, SPRAY TOPICAL 20100315 OTC MONOGRAPH FINAL part333C Cardinal Health Inc. MICONAZOLE NITRATE 2.6 g/130g 37808-001_ea34841f-c541-44fe-bd7b-e4687a294922 37808-001 HUMAN OTC DRUG Anti Nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 19951122 UNAPPROVED DRUG OTHER H E B DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 37808-002_185d4eb2-8f81-412f-8b96-36c74be7f899 37808-002 HUMAN OTC DRUG enema saline Saline ENEMA RECTAL 20091116 OTC MONOGRAPH NOT FINAL part334 H E B SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 37808-003_ec75ed58-f0b5-4b78-9285-9aee02cdd503 37808-003 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130601 OTC MONOGRAPH NOT FINAL part356 H E B EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 37808-004_3c301993-642a-487c-96a2-ebc4ef90dc88 37808-004 HUMAN OTC DRUG nasal oxymetazoline hydrochloride SPRAY NASAL 20141202 OTC MONOGRAPH FINAL part341 H E B OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 37808-008_c3a994fb-b824-4932-9ea5-03d1a520d716 37808-008 HUMAN OTC DRUG rx act pain relief infants Acetaminophen SUSPENSION/ DROPS ORAL 19910615 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 80 mg/.8mL 37808-009_3d77354c-e92e-4c58-8c84-9a24c89401b6 37808-009 HUMAN OTC DRUG Healing petrolatum OINTMENT TOPICAL 20110415 OTC MONOGRAPH FINAL part347 H E B PETROLATUM 340 mg/g 37808-010_b97ce9a9-1721-4554-807e-044687317387 37808-010 HUMAN OTC DRUG Rx Act Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20050527 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 500 mg/1 37808-011_9c97e809-a16b-4a6e-b0a1-3f51a2cfc8f9 37808-011 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20131211 OTC MONOGRAPH NOT FINAL part348 HEB MENTHOL 1.5 mg/g 37808-015_b52526c9-255c-465e-b869-d5c2e65c010f 37808-015 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20100729 OTC MONOGRAPH FINAL part347 H E B PETROLATUM 1 g/g 37808-020_d66b86e6-7b83-4d84-9d52-b7ff0ccc232c 37808-020 HUMAN OTC DRUG Diaper Rash Zinc oxide PASTE TOPICAL 20100910 OTC MONOGRAPH FINAL part347 H E B ZINC OXIDE 532 mg/g 37808-025_5146946d-b52d-4fe3-89e2-8c7875fea456 37808-025 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH FINAL part338 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 37808-027_28169c45-26a1-4151-a521-00475e594ed7 37808-027 HUMAN OTC DRUG allergy eye Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20100915 ANDA ANDA077958 H E B KETOTIFEN FUMARATE .25 mg/mL 37808-029_a66e6ea7-5883-4986-9aec-fe46f83b322a 37808-029 HUMAN OTC DRUG In control nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050606 ANDA ANDA076775 H E B NICOTINE 2 mg/1 37808-031_d91cadf9-9a94-47f1-a1d7-afdd03882198 37808-031 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19910915 OTC MONOGRAPH NOT FINAL part356 H E B ASPIRIN 325 mg/1 37808-036_12e7f0e2-4007-440f-a8b0-72948909f887 37808-036 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20140409 ANDA ANDA090283 HEB FAMOTIDINE 20 mg/1 37808-038_227de322-e94b-4656-b56e-c32e6f1b76b8 37808-038 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH NOT FINAL part334 H E B DOCUSATE SODIUM 100 mg/1 37808-046_82c3b718-b8ca-4186-8f66-4218421f92a7 37808-046 HUMAN OTC DRUG Rx Act Pain Relief Rapid Release Acetaminophen TABLET, COATED ORAL 20100201 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 500 mg/1 37808-047_a04849da-60a4-4e47-8ac2-6f4f95a46304 37808-047 HUMAN OTC DRUG Rx Act Heartburn Relief Ranitidine TABLET ORAL 20080220 ANDA ANDA078653 H E B RANITIDINE HYDROCHLORIDE 150 mg/1 37808-050_f341b4ca-dae3-4a0d-b64d-10f29528be48 37808-050 HUMAN OTC DRUG rx act ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090311 ANDA ANDA079113 H E B DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 37808-056_49f5f4d3-556c-4ee3-b5cd-5331dd434bb9 37808-056 HUMAN OTC DRUG night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140414 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 37808-057_e353bc69-c03e-4bae-a357-f7f3fab91695 37808-057 HUMAN OTC DRUG ibuprofen infants ibuprofen SUSPENSION ORAL 20020618 ANDA ANDA075217 H E B IBUPROFEN 50 mg/1.25mL 37808-061_95e690e3-0dae-4606-8d6d-d7a6e7ba41ec 37808-061 HUMAN OTC DRUG night time cold and flu multi symptom Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20110610 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 37808-065_3329fd13-833c-41bc-ab7a-aed7520f9c85 37808-065 HUMAN OTC DRUG rx act nasal extra moisturizing Oxymetazoline HCl SPRAY NASAL 19951012 OTC MONOGRAPH FINAL part341 H E B OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 37808-066_6e406280-eafc-4f10-9426-f6f8b0783889 37808-066 HUMAN OTC DRUG ORCHID JASMINE TEA AND BASIL ETHYL ALCOHOL LIQUID TOPICAL 20140317 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 620 mg/mL 37808-067_d7c2fe3e-6baa-4e57-b197-535751d7b353 37808-067 HUMAN OTC DRUG triple antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20100823 OTC MONOGRAPH FINAL part333B H E B BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 37808-069_71d8ae83-fe41-466f-bb3c-a048179f2b49 37808-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 20090803 OTC MONOGRAPH FINAL part347 H E B PETROLATUM 1 g/g 37808-072_c3ef3897-9cae-4900-afa2-2d59ee69060e 37808-072 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19950425 OTC MONOGRAPH NOT FINAL part356 H-E-B EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 37808-080_c530d751-6e39-46e3-b400-2952497fc6a2 37808-080 HUMAN OTC DRUG Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 H E B TERBINAFINE HYDROCHLORIDE 1 g/100g 37808-081_09a79382-805e-42e1-8ee8-a24b1212eb03 37808-081 HUMAN OTC DRUG ORCHID BY H E B ANTIBACTERIAL HAND WHITE LAVENDER AND MINT TRICLOSAN LIQUID TOPICAL 20141218 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN 3 mg/mL 37808-082_90124ce6-7802-42f6-b733-0d1d3fc5446e 37808-082 HUMAN OTC DRUG ORCHID BY H E B CACTUS FLOWER AND MANGO ANTIBACTERIAL GENTLE FOAMING HAND TRICLOSAN LIQUID TOPICAL 20140731 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN 3 mg/mL 37808-085_05953fc3-e0c3-4257-a0cd-cc89ca69fc3c 37808-085 HUMAN OTC DRUG Allergy Relief Childrens Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 H E B LORATADINE 5 mg/5mL 37808-090_b9484a9c-e288-4fac-ac77-cc9a6b3fc829 37808-090 HUMAN OTC DRUG ORCHID JASMINE TEA AND BASIL TRICLOSAN LIQUID TOPICAL 20130812 OTC MONOGRAPH NOT FINAL part333E H.E.B. TRICLOSAN 3 mg/mL 37808-091_c7a44eda-3cd9-454f-9174-462366c14a46 37808-091 HUMAN OTC DRUG ORCHID CACTUS FLOWER AND MANGO TRICLOSAN LIQUID TOPICAL 20130812 OTC MONOGRAPH NOT FINAL part333E H.E.B. TRICLOSAN 3 mg/mL 37808-092_ab180244-bd0b-486e-a359-88080e43ecf9 37808-092 HUMAN OTC DRUG Allergy Relief Childrens Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 H E B LORATADINE 5 mg/5mL 37808-094_44bb5c56-6e9d-461d-96fe-d099577f7188 37808-094 HUMAN OTC DRUG rx act nasal decongestant pe non drowsy maximum strength Phenylephrine Hydrochloride TABLET ORAL 20050607 OTC MONOGRAPH FINAL part341 H E B PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 37808-096_16f24b2b-7b55-461d-b137-720a27fc011c 37808-096 HUMAN OTC DRUG Rx Act Flu and severe cold and cough daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20120117 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 37808-097_19edb3a9-214d-498a-8f5b-04ba4e045095 37808-097 HUMAN OTC DRUG ORCHID BY H E B WHITE LAVENDER AND MINT TRICLOSAN LIQUID TOPICAL 20140424 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN 3 mg/mL 37808-102_4d7be6f8-972e-40cc-a23d-6bdce28b47af 37808-102 HUMAN OTC DRUG HEB Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 H E B CETIRIZINE HYDROCHLORIDE 5 mg/5mL 37808-107_5c8ffeb0-67a2-46b8-9217-483fb7a67183 37808-107 HUMAN OTC DRUG ORCHID BY H E B VANILLA BROWN SUGAR TRICLOSAN LIQUID TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN 4.6 mg/mL 37808-110_55338e74-c851-4298-a455-d67517c2a28f 37808-110 HUMAN OTC DRUG feminine Povidone-iodine KIT 20091120 OTC MONOGRAPH NOT FINAL part333A H E B 37808-112_39afbbd7-2816-4502-aa9a-83b7a05227ca 37808-112 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET ORAL 19810825 OTC MONOGRAPH FINAL part341 H E B PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 37808-117_457f477b-01bb-479b-a279-b201047fdc6b 37808-117 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 H E B LANSOPRAZOLE 15 mg/1 37808-124_6dccf17c-0f3b-4a13-befd-8107f098a60e 37808-124 HUMAN OTC DRUG in control nicotine Nicotine Polacrilex LOZENGE ORAL 20100215 ANDA ANDA090711 H E B NICOTINE 2 mg/1 37808-130_cd0335e2-980e-40b5-836d-cc3070683908 37808-130 HUMAN OTC DRUG pain relief Acetaminophen SUSPENSION ORAL 19900315 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 160 mg/5mL 37808-133_44481b11-7f19-4d59-9a01-849ee35e610a 37808-133 HUMAN OTC DRUG rx act flu and sore throat acetaminophen,pheniramine maleate, phenylephrine hydrochloride POWDER, FOR SUSPENSION ORAL 20101229 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/15000mg; mg/15000mg; mg/15000mg 37808-140_422fff1d-8c2b-4829-a772-e3fef3b42694 37808-140 HUMAN OTC DRUG rx act all day pain relief Naproxen sodium TABLET, FILM COATED ORAL 20080212 ANDA ANDA074661 H E B NAPROXEN SODIUM 220 mg/1 37808-141_935d295c-6876-434d-b8d6-674a1207bf0b 37808-141 HUMAN OTC DRUG heartburn prevention acid reducer Famotidine TABLET ORAL 20090911 ANDA ANDA075400 H E B FAMOTIDINE 10 mg/1 37808-144_4e8e7439-9834-4d67-adb9-72f08a08686f 37808-144 HUMAN OTC DRUG Antacid Regular Strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19920618 OTC MONOGRAPH FINAL part331 H E B ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 37808-146_36f1bf50-56c9-43d3-a71d-1c47c9215688 37808-146 HUMAN OTC DRUG in control nicotine Nicotine Polacrilex LOZENGE ORAL 20140606 ANDA ANDA090821 H E B NICOTINE 2 mg/1 37808-157_29d932eb-ba45-4ef8-b0fa-d8fe582673ea 37808-157 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20060210 OTC MONOGRAPH FINAL part343 H E B ASPIRIN 325 mg/1 37808-160_e62b741c-1c1f-4bac-809a-3c315c12c276 37808-160 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20121111 OTC MONOGRAPH FINAL part346 H E B COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g 37808-161_408d746d-b824-4292-8c1d-a3b1b2a94410 37808-161 HUMAN OTC DRUG Pain and Fever Acetaminophen LIQUID ORAL 20111215 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 160 mg/5mL 37808-162_a90e2b7e-0091-43c0-907c-97b5d699b220 37808-162 HUMAN OTC DRUG h e buddy antibiotic maximum strength plus pain relief Neomycin, Polymyxin B, Pramoxine Hcl CREAM TOPICAL 20110128 OTC MONOGRAPH FINAL part333B H E B NEOMYCIN; POLYMYXIN B; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 37808-163_1c505a56-b5af-4cd8-81d1-9a9b1a91bc83 37808-163 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20100929 OTC MONOGRAPH FINAL part355 HEB SODIUM FLUORIDE 1 mg/mL 37808-165_24273bb8-9f20-4002-8094-a5640daa0650 37808-165 HUMAN OTC DRUG ORCHID ANTIBACTERIAL VANILLA AND APPLE BLOSSOM ETHYL ALCOHOL LIQUID TOPICAL 20141117 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 620 mg/mL 37808-166_f8170bcb-76ec-4b9a-8343-74c82a7dc6d5 37808-166 HUMAN OTC DRUG rx act ibuprofen childrens Ibuprofen SUSPENSION ORAL 20020610 ANDA ANDA074937 H E B IBUPROFEN 100 mg/5mL 37808-167_9338b577-c3b2-4f2e-b9c1-67d3494b6c7c 37808-167 HUMAN OTC DRUG HEB HEBuddy Fluoride PASTE, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 HEB SODIUM FLUORIDE .243 g/100g 37808-168_60f2a0c3-1e62-4521-9851-91616fa8fbb4 37808-168 HUMAN OTC DRUG Hill Country Essentials Antibacterial Foaming Triclosan SOAP TOPICAL 20100722 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .6 mL/100mL 37808-168_7e7a8137-a809-4efb-8a06-cf9e00a6956a 37808-168 HUMAN OTC DRUG Hill Country Essentials Antibacterial Foaming Triclosan SOAP TOPICAL 20100722 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .6 mL/100mL 37808-169_03ecba75-be3f-4333-bd0d-a407354aec11 37808-169 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110616 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN .46 mL/100mL 37808-170_a8056b72-570e-42e2-8f54-266186fd8fc2 37808-170 HUMAN OTC DRUG in control nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050615 ANDA ANDA076789 H E B NICOTINE 4 mg/1 37808-171_7f40fc97-a527-448b-858f-d5052a48160b 37808-171 HUMAN OTC DRUG HEB Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 HEB STANNOUS FLUORIDE .454 g/100g 37808-176_dec0b291-43ed-42b3-8572-a0a22265557a 37808-176 HUMAN OTC DRUG all day Allergy Relief D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080502 ANDA ANDA077170 H E B CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 37808-177_f200d420-8264-41ae-8cf5-b3cfe9b42874 37808-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110909 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN .46 mL/100mL 37808-177_f2634a39-c687-422e-a4c9-a46c88718665 37808-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111102 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN .46 mL/100mL 37808-179_abc59658-d475-4d55-acd4-12f69bd4721f 37808-179 HUMAN OTC DRUG rx act antacid extra strength Calcium carbonate TABLET, CHEWABLE ORAL 19960313 OTC MONOGRAPH FINAL part331 H E B CALCIUM CARBONATE 750 mg/1 37808-180_295d4618-3c73-45e0-b0ec-46302db61d1b 37808-180 HUMAN OTC DRUG Senna Laxative Natural Vegetable Laxative SENNOSIDES TABLET ORAL 20100729 OTC MONOGRAPH NOT FINAL part334 H E B SENNOSIDES 8.6 mg/1 37808-181_789d7ac6-ff4b-4952-af3b-e194ec9ded81 37808-181 HUMAN OTC DRUG WHITE LAVENDAR AND MINT ANTIBACTERIAL GENTLE FOAMING HAND SP TRICLOSAN LIQUID TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .3 mL/100mL 37808-182_9f8b86c2-66bc-4b90-8add-2a4b7fe266aa 37808-182 HUMAN OTC DRUG CACTUS FLOWER AND MANGO ANTIBACTERIAL GENTLE FOAMING HAND SP TRICLOSAN LIQUID TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .3 mL/100mL 37808-183_1b609b82-1682-4b60-9a38-f84ac944c81f 37808-183 HUMAN OTC DRUG rx act ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19940204 ANDA ANDA077349 H E B IBUPROFEN 200 mg/1 37808-186_b11c5b8c-5949-492b-9d59-8c2906d7e2e8 37808-186 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl SOLUTION ORAL 20131030 OTC MONOGRAPH FINAL part338 H E B DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 37808-188_169ac371-c3da-44f8-8b8d-072c39654a93 37808-188 HUMAN OTC DRUG Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140420 OTC MONOGRAPH FINAL part346 H E B MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 37808-190_98042542-4085-41e9-8659-8dbfb5d538e6 37808-190 HUMAN OTC DRUG in control nicotine Nicotine Polacrilex LOZENGE ORAL 20100215 ANDA ANDA090711 H E B NICOTINE 4 mg/1 37808-192_297c8aba-098c-4147-a984-f05b11c6354f 37808-192 HUMAN OTC DRUG HEB HEBuddy Fluoride PASTE, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 HEB SODIUM FLUORIDE .243 g/100g 37808-194_604cb86a-24f7-4f5d-9a22-2b904029afd0 37808-194 HUMAN OTC DRUG Rx Act Heartburn Prevention maximum strength Famotidine TABLET ORAL 20060928 ANDA ANDA077351 H E B FAMOTIDINE 20 mg/1 37808-195_52bac9ce-4504-46e0-b8c3-7014ff42fe01 37808-195 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 500 mg/1 37808-198_ead4ea69-370b-4ba8-921c-88cbb27541d7 37808-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130108 ANDA ANDA078682 H E B IBUPROFEN 200 mg/1 37808-199_40cc911b-2c35-4382-a979-fb1a165049db 37808-199 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100607 ANDA ANDA079114 H E B 37808-200_e7e2b766-6d05-49e2-9e88-72454b857935 37808-200 HUMAN OTC DRUG childrens ibuprofen Ibuprofen SUSPENSION ORAL 20020619 ANDA ANDA074937 H E B IBUPROFEN 100 mg/5mL 37808-201_34054115-a72e-4476-b17c-e93f4c2e4f6f 37808-201 HUMAN OTC DRUG ORCHID BY H E B VANILLA BROWN SUGAR ETHYL ALCOHOL LIQUID TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 650 mg/mL 37808-202_98d71602-ca25-48be-8a63-3ead4e8201e7 37808-202 HUMAN OTC DRUG Minoxidil minoxidil SOLUTION TOPICAL 20110404 ANDA ANDA075357 H E B MINOXIDIL 2 g/100mL 37808-204_c3f938d3-316f-4596-9dc3-187a20a7979b 37808-204 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 HEB PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 37808-206_408a413f-bb97-4089-ac9d-5f777c11e812 37808-206 HUMAN OTC DRUG In Control Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050615 ANDA ANDA078325 H E B NICOTINE 2 mg/1 37808-208_cfe60090-ff71-40dc-9eca-2a2a8e7865ae 37808-208 HUMAN OTC DRUG H-E-B Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 H E B CETIRIZINE HYDROCHLORIDE 5 mg/5mL 37808-210_e7868625-4ca0-434e-8a29-fcc1a4519445 37808-210 HUMAN OTC DRUG Advanced Antiseptic Citrus EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL MOUTHWASH ORAL 20101015 OTC MONOGRAPH NOT FINAL part356 H E B EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .042 mL/100L; mL/100L; mL/100L; mL/100L 37808-211_62a2eab6-690e-4c04-974c-2ecd79c3ae24 37808-211 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20131009 NDA NDA022429 H E B CETIRIZINE HYDROCHLORIDE 10 mg/1 37808-215_cc958100-a918-46f9-9f70-20617a889a40 37808-215 HUMAN OTC DRUG HILL COUNTRY ESSENTIALS TRICLOSAN LIQUID TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333E H.E.B. TRICLOSAN 1.5 mg/mL 37808-217_48e1a103-5ac8-4510-8dac-423392aa7bf3 37808-217 HUMAN OTC DRUG rx act pain relief 8 HR Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051001 ANDA ANDA075077 H E B ACETAMINOPHEN 650 mg/1 37808-219_2d4c5993-0922-4c1b-acb3-977ea048e604 37808-219 HUMAN OTC DRUG Blackhead Clearing Scrub Salicylic acid GEL TOPICAL 20090623 OTC MONOGRAPH FINAL part333D H E B SALICYLIC ACID 19.4 mg/g 37808-220_9ad63cc4-b300-4634-a34d-b1fab1aa30d8 37808-220 HUMAN OTC DRUG Hill Country Essentials Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .15 mL/100mL 37808-220_cc740934-d7ed-4c22-8fba-e989f9efa142 37808-220 HUMAN OTC DRUG Hill Country Essentials Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .15 mL/100mL 37808-224_9be9bd2e-cecf-46c7-a6db-ecd5b52f26ea 37808-224 HUMAN OTC DRUG rx act anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030324 ANDA ANDA075232 H E B LOPERAMIDE HYDROCHLORIDE 2 mg/1 37808-225_0faef1c4-1af2-4b9b-a44d-8d2914a4392f 37808-225 HUMAN OTC DRUG HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20100705 OTC MONOGRAPH NOT FINAL part333 HEB ALCOHOL 62 mL/100mL 37808-227_130c53bb-2548-4314-aba9-a3f5a2508b54 37808-227 HUMAN OTC DRUG rx act pain relief extra strength Acetaminophen TABLET, COATED ORAL 20060106 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 500 mg/1 37808-230_1ec2c62a-f2c2-44b9-ad56-95c2cf47d28d 37808-230 HUMAN OTC DRUG H E B Restore and Defend Fluoride PASTE, DENTIFRICE DENTAL 20140701 OTC MONOGRAPH FINAL part355 HEB STANNOUS FLUORIDE .15 g/100g 37808-234_410ac39d-362f-431f-bffd-ec5ab86f1c4d 37808-234 HUMAN OTC DRUG cold relief head congestion Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20080310 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 37808-235_cbd9e5c4-e22d-4bbc-8bee-60af7e7980c3 37808-235 HUMAN OTC DRUG ANTIBACTERIAL SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20110808 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 62 mL/100mL 37808-236_a1ca1bdc-321f-469b-ae59-6d0e6279cf62 37808-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140530 OTC MONOGRAPH FINAL part338 H E B DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 37808-238_fb4d941d-3af3-4898-a3de-cf75e7e06b02 37808-238 HUMAN OTC DRUG HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110203 OTC MONOGRAPH NOT FINAL part333E HEB ALCOHOL 62 mL/100mL 37808-239_eb1dccb7-b4d4-4613-8bd7-e2df542220ab 37808-239 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH NOT FINAL part334 H E B DOCUSATE SODIUM 100 mg/1 37808-240_f93fa0b3-7551-443b-981d-d3dd5cbefed5 37808-240 HUMAN OTC DRUG FOAMING HAND SANITIZER WITH ALOE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part333 HEB BENZALKONIUM CHLORIDE .1 mL/100mL 37808-244_ab7556fb-4a18-4487-a34d-32a765e44707 37808-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140328 OTC MONOGRAPH NOT FINAL part334 H E B DOCUSATE SODIUM 100 mg/1 37808-245_7835aaef-4285-40d3-80a4-cab566b0bc1f 37808-245 HUMAN OTC DRUG Laxative Pills Sennosides TABLET ORAL 20141031 OTC MONOGRAPH NOT FINAL part334 H E B SENNOSIDES 25 mg/1 37808-250_d938a3ce-e763-4997-be64-f6ab5b3cd1b9 37808-250 HUMAN OTC DRUG cold relief Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20090211 OTC MONOGRAPH FINAL part341 H E B 37808-251_a3ea52f0-8774-41fd-93ed-0c54e357c6d2 37808-251 HUMAN OTC DRUG junior strength ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20100901 ANDA ANDA076359 H E B IBUPROFEN 100 mg/1 37808-252_27f24775-9c7e-4304-85cc-992f2ffcd36a 37808-252 HUMAN OTC DRUG Sleep Aid Nighttime diphenhydramine hydrochloride TABLET ORAL 20140831 OTC MONOGRAPH FINAL part338 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 37808-253_a674048f-b46f-44ab-90b3-9a0ec99c276a 37808-253 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20100202 OTC MONOGRAPH NOT FINAL part333 HEB ALCOHOL 65 mL/100mL 37808-254_ada0a890-6761-44c5-aa03-ed4eec1f4cdb 37808-254 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH ALOE ETHYL ALCOHOL GEL TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333E HEB ALCOHOL 65 mL/100mL 37808-255_2c67fecb-2e69-44d6-8ab8-3251abae72a6 37808-255 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20050225 ANDA ANDA075217 H E B IBUPROFEN 50 mg/1.25mL 37808-259_73745306-18b8-4ba1-af73-d28fc3fbbf08 37808-259 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 19970224 ANDA ANDA074661 H E B NAPROXEN SODIUM 220 mg/1 37808-263_58a4d263-e234-43cd-a3bd-b19a492174d9 37808-263 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20141014 OTC MONOGRAPH FINAL part333B H E B BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP&apos'U]/g; mg/g; [USP&apos'U]/g 37808-265_698e3c0d-b760-4ec7-9631-65c2c47fb097 37808-265 HUMAN OTC DRUG VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part333E HEB ALCOHOL 62 mL/100mL 37808-265_77cc3aa7-aaaf-4185-8f57-ddbbd7941cb1 37808-265 HUMAN OTC DRUG VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part333E HEB ALCOHOL 62 mL/100mL 37808-266_720daeb3-e84f-4616-9aba-a7ef7cff220a 37808-266 HUMAN OTC DRUG JASMINE TEA AND BASIL ANTIBACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part333E HEB ALCOHOL 62 mL/100mL 37808-266_da7c4ac0-3656-4a53-bdf9-ac0f26ee97f2 37808-266 HUMAN OTC DRUG JASMINE TEA AND BASIL ANTIBACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part333E HEB ALCOHOL 62 mL/100mL 37808-267_ff8625dd-b6e3-4f50-a25c-a44f68052679 37808-267 HUMAN OTC DRUG HEB JASMINE TEA AND BASIL ETHYL ALCOHOL LIQUID TOPICAL 20131106 OTC MONOGRAPH NOT FINAL part333E HEB ALCOHOL 620 mg/mL 37808-272_880d332e-5eb8-4c66-9041-76aa6949a1d7 37808-272 HUMAN OTC DRUG Rx Act sinus congestion and pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20070129 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 37808-274_2508ac4e-7604-4646-9f92-d5df7e411e5c 37808-274 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 19980218 OTC MONOGRAPH NOT FINAL part343 H E B ASPIRIN 81 mg/1 37808-277_996f2864-5dc9-4a56-8a8e-9f4a12648770 37808-277 HUMAN OTC DRUG aspirin adult low strength Aspirin TABLET, FILM COATED ORAL 20050322 OTC MONOGRAPH NOT FINAL part343 H E B ASPIRIN 81 mg/1 37808-279_1435432d-5ff2-468b-808d-fb0c99a0717b 37808-279 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140930 OTC MONOGRAPH FINAL part346 H E B COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 37808-282_8c94d63d-ed19-4161-b733-263de6554faa 37808-282 HUMAN OTC DRUG dayhist allergy Clemastine fumarate TABLET ORAL 19950830 ANDA ANDA074512 H E B CLEMASTINE FUMARATE 1.34 mg/1 37808-288_2ab5df46-4095-46e6-a0b3-186852e14e1b 37808-288 HUMAN OTC DRUG Childrens mucus relief Guaifenesin LIQUID ORAL 20090105 OTC MONOGRAPH FINAL part341 H E B GUAIFENESIN 100 mg/5mL 37808-289_75602309-5bed-446b-b538-ad42e279a993 37808-289 HUMAN OTC DRUG VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL MOISTURIZING HAND SP TRICLOSAN LIQUID TOPICAL 20101223 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .3 mL/100mL 37808-290_d1ac225d-65e4-4f3f-acd2-ae69f2491298 37808-290 HUMAN OTC DRUG JASMINE TEA AND BASIL ANTIBACTERIAL HAND SP TRICLOSAN LIQUID TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .3 mL/100mL 37808-291_1d7af611-bb60-42e7-98e3-247ad9832486 37808-291 HUMAN OTC DRUG CACTUS FLOWER AND MANGO ANTIBACTERIAL DEEP CLEANSING HAND SP TRICLOSAN LIQUID TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .3 mL/100mL 37808-292_ccefeaa7-825d-4a20-baf2-3acaf4418f1e 37808-292 HUMAN OTC DRUG WHITE LAVENDER AND MINT ANTIBACTERIAL MOISTURIZING HAND SP TRICLOSAN LIQUID TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN .3 mL/100mL 37808-294_00b97aa0-26c3-4fdf-bb5e-1ca1b733b958 37808-294 HUMAN OTC DRUG HILL COUNTRY ESSENTIALS ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20121212 OTC MONOGRAPH NOT FINAL part333E H.E.B. TRICLOSAN 1.5 mg/mL 37808-297_12f767dc-7524-405c-9981-3e4e7cdb2d52 37808-297 HUMAN OTC DRUG ORCHID TRICLOSAN LIQUID TOPICAL 20120412 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .3 mL/100mL 37808-299_1ac73234-b66a-4e49-a520-dee6dca65354 37808-299 HUMAN OTC DRUG Alcohol Free Cetylpyridinium cloride MOUTHWASH ORAL 20090416 OTC MONOGRAPH NOT FINAL part356 H-E-B CETYLPYRIDINIUM CHLORIDE .7 mg/mL 37808-300_b98bfb96-817c-47dc-833b-799f8f84dc15 37808-300 HUMAN OTC DRUG RX Act Tussin Cough Dextromethorphan Hydrobromide LIQUID ORAL 19920505 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 37808-304_c71d5ed2-345f-4c8a-a74e-319cee70a334 37808-304 HUMAN OTC DRUG rx act nasal original oxymetazoline hydrochloride SPRAY NASAL 19920203 OTC MONOGRAPH FINAL part341 H E B OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 37808-305_5f9c167c-5001-4041-96fe-e5cdf1f614cb 37808-305 HUMAN OTC DRUG HEB Antifungal Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C H E B CLOTRIMAZOLE 10 mg/g 37808-306_3bbbc06e-a84e-4bcf-82cc-a7f05c584d21 37808-306 HUMAN OTC DRUG clear lax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091008 ANDA ANDA090685 H E B POLYETHYLENE GLYCOL 3350 17 g/17g 37808-308_96c05f14-1699-4260-95b2-7468bfb88502 37808-308 HUMAN OTC DRUG cold relief multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20090227 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 37808-310_848656bf-6848-4c49-8d11-08cfee1bfbcc 37808-310 HUMAN OTC DRUG Rx Act Tussin Chest Congestion Guaifenesin SYRUP ORAL 19970508 OTC MONOGRAPH FINAL part341 H E B GUAIFENESIN 100 mg/5mL 37808-314_4bd1a5e7-744c-411a-bc60-14dfea68e316 37808-314 HUMAN OTC DRUG HEB Severe Toothache Benzocaine PASTE, DENTIFRICE TOPICAL 20110120 OTC MONOGRAPH FINAL part333B HEB BENZOCAINE 20 g/100g 37808-316_1f691a38-28f3-474c-ba4b-5ccefd52b2b5 37808-316 HUMAN OTC DRUG MAX Cold, Flu, and Sore Throat ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL LIQUID ORAL 20140305 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL 37808-317_34a10448-45e4-4406-a70a-87909df8d145 37808-317 HUMAN OTC DRUG H E B MAX SEVERE CONGESTION and COUGH Maxium Strength DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20120914 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL 37808-321_8d7f669f-18fb-4574-836c-2b97a25c5018 37808-321 HUMAN OTC DRUG Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080914 ANDA ANDA077355 H E B CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 37808-326_bbc3582c-ddee-41c5-b82d-d831a8c9864c 37808-326 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20050212 OTC MONOGRAPH NOT FINAL part334 H E B BISACODYL 5 mg/1 37808-327_889d2cb2-de9e-42b0-bbc7-d5b35525655b 37808-327 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 H E B BISACODYL 5 mg/1 37808-328_f68bea6b-a5e8-4911-9d92-4f384db2114f 37808-328 HUMAN OTC DRUG sore throat Phenol SPRAY ORAL 19941012 OTC MONOGRAPH NOT FINAL part356 H E B PHENOL 1.4 mL/100mL 37808-329_469f4511-61e0-4a1a-b450-ae0f3aa1a67d 37808-329 HUMAN OTC DRUG Antihistamine Allergy Diphenhydramine HCl CAPSULE, COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 37808-332_4bdbb676-71ea-4a9b-b047-048e31ed1cb3 37808-332 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide LIQUID ORAL 19941014 OTC MONOGRAPH NOT FINAL part334 H E B MAGNESIUM HYDROXIDE 1200 mg/15mL 37808-333_a67ea2d8-b415-4468-9e7a-bae4172428a0 37808-333 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 H-E-B ACETAMINOPHEN 650 mg/1 37808-335_f924df2f-e684-487e-8cb9-11ede11fd1ee 37808-335 HUMAN OTC DRUG night time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20130207 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 37808-339_c4d4987f-0bf8-437d-a71f-f1993e04323c 37808-339 HUMAN OTC DRUG all day pain relief Naproxen sodium TABLET, FILM COATED ORAL 20080212 ANDA ANDA074661 H E B NAPROXEN SODIUM 200 mg/1 37808-343_50305471-7ff7-4e02-b91b-b3f338a5824d 37808-343 HUMAN OTC DRUG Rx Act Sore Throat Phenol SPRAY ORAL 19941025 OTC MONOGRAPH NOT FINAL part356 H E B PHENOL 1.4 mL/100mL 37808-344_5ac73c93-0005-4690-8f02-6342e35b3bbc 37808-344 HUMAN OTC DRUG in control Nicotine Nicotine Polacrilex LOZENGE ORAL 20070725 ANDA ANDA077007 H E B NICOTINE 2 mg/1 37808-346_c15a2f34-2be2-4f27-92de-e9a6f4247782 37808-346 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate CAPSULE ORAL 20110506 OTC MONOGRAPH FINAL part335 H E B BISMUTH SUBSALICYLATE 262 mg/1 37808-351_176a7c7c-01cc-445e-868d-3f950ac1605e 37808-351 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20140411 ANDA ANDA200536 H E B RANITIDINE HYDROCHLORIDE 150 mg/1 37808-352_79c1962d-bdc7-4efa-aa49-cf42f0b5f02c 37808-352 HUMAN OTC DRUG In Control Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20071213 ANDA ANDA078547 H E B NICOTINE 2 mg/1 37808-357_bb75fafa-f29c-4685-bf99-87e6e6863dbb 37808-357 HUMAN OTC DRUG Rx Act Antacid regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19920618 OTC MONOGRAPH FINAL part332 H E B ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 37808-358_0a8074dc-20c0-4953-8306-57103dbe2a66 37808-358 HUMAN OTC DRUG Rx Act sinus and allergy PE Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20100521 OTC MONOGRAPH FINAL part341 H E B CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 37808-359_4453d4be-2c6d-40fe-b1ed-dc0235d67739 37808-359 HUMAN OTC DRUG Tussin DM Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 19910809 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 37808-363_0a9a54ce-572f-4a96-922f-cc136d2d4aad 37808-363 HUMAN OTC DRUG Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20020610 ANDA ANDA074937 H E B IBUPROFEN 100 mg/5mL 37808-368_df6fbdff-f101-4780-8ea5-95c1ac7222a4 37808-368 HUMAN OTC DRUG rx act all day pain relief Naproxen Sodium TABLET, FILM COATED ORAL 20090212 ANDA ANDA074661 H E B NAPROXEN SODIUM 220 mg/1 37808-369_ecbd50a9-74a3-4974-a870-d7bb7a028ec4 37808-369 HUMAN OTC DRUG hydrocortisone anti itch Hydrocortisone CREAM TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part348 H E B HYDROCORTISONE 1 g/100g 37808-374_2a50f9c9-2232-46d9-b9b3-39a17d174711 37808-374 HUMAN OTC DRUG migraine formula Acetaminophen, Aspirin, Caffeine TABLET ORAL 20020515 ANDA ANDA075794 H E B ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 37808-375_4a3d928e-1926-4f40-a877-2765f37df953 37808-375 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 H E B LOPERAMIDE HYDROCHLORIDE 2 mg/1 37808-377_b2168682-c019-4b7f-83a9-42e995b28ded 37808-377 HUMAN OTC DRUG rx act anti diarrheal Loperamide HCl SOLUTION ORAL 19920514 ANDA ANDA073243 H E B LOPERAMIDE HYDROCHLORIDE 1 mg/5mL 37808-379_2d1715b3-b1cf-455d-9909-f6d58c97db40 37808-379 HUMAN OTC DRUG Allergy Diphenhydramine HCl LIQUID ORAL 19870715 OTC MONOGRAPH FINAL part341 H E B DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 37808-384_f8f225cd-a0f2-4991-828f-cc7549778235 37808-384 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120830 ANDA ANDA091135 H E B DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 37808-386_d701350b-646b-43f1-a951-9d657ecc166d 37808-386 HUMAN OTC DRUG Sleep-Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 H E B DOXYLAMINE SUCCINATE 25 mg/1 37808-390_e3345008-7af0-4cbe-9d13-44dfe8b21442 37808-390 HUMAN OTC DRUG Menstrual Complete Acetaminophen, Caffeine, Pyrilamine maleate TABLET ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 37808-393_d277ad83-101a-4178-851b-dac26ee7e0dc 37808-393 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, COATED ORAL 20020408 ANDA ANDA075139 H E B IBUPROFEN 200 mg/1 37808-394_b387c743-063a-42d4-8ed7-530f60705dd2 37808-394 HUMAN OTC DRUG Hemorrhoidal Cocoa butter, Phenylephrine HCl, Shark liver oil SUPPOSITORY RECTAL 19980415 OTC MONOGRAPH FINAL part346 H E B COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2137.5; 75; 6.375 mg/1; mg/1; mg/1 37808-396_2c87476a-d1f9-4a31-91ad-099e658f21e4 37808-396 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide LIQUID ORAL 19920609 OTC MONOGRAPH NOT FINAL part334 H E B MAGNESIUM HYDROXIDE 1200 mg/15mL 37808-397_ad2890b7-1d55-4380-838d-11611c6684f5 37808-397 HUMAN OTC DRUG Vaproizing Camphor LIQUID RESPIRATORY (INHALATION) 20101006 OTC MONOGRAPH FINAL part341 H E B CAMPHOR (NATURAL) 62 mg/mL 37808-400_2c871011-3507-4de6-b254-8121d030c299 37808-400 HUMAN OTC DRUG Rx Act Hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 19951222 OTC MONOGRAPH FINAL part346 H E B MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 37808-402_e0b979fa-ebe8-440e-bb2f-6e5cfb3293aa 37808-402 HUMAN OTC DRUG Rx Act Cold Head Congestion Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070507 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 37808-403_b3a4260d-800e-4993-8990-fe6a1a3d19a1 37808-403 HUMAN OTC DRUG rx act pain relief regular strength Acetaminophen TABLET ORAL 19920915 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 325 mg/1 37808-404_d46f97ce-2630-4da8-820a-bc2e1005068f 37808-404 HUMAN OTC DRUG minoxidil Minoxidil AEROSOL, FOAM TOPICAL 20120301 ANDA ANDA091344 H E B MINOXIDIL 5 g/100g 37808-405_491e9055-7981-4d56-9acf-3b267e8eab0c 37808-405 HUMAN OTC DRUG ORCHID BY H E B VANILLA BROWN SUGAR ETHYL ALCOHOL LIQUID TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 650 mg/mL 37808-405_706297f9-9ab3-4ef1-ab50-5bcf901c3ba0 37808-405 HUMAN OTC DRUG ORCHID BY H E B VANILLA BROWN SUGAR ETHYL ALCOHOL LIQUID TOPICAL 20140302 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 650 mg/mL 37808-409_28d25382-e40f-479d-a6de-ce68bec9cc26 37808-409 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19960325 OTC MONOGRAPH FINAL part340 H E B CAFFEINE 200 mg/1 37808-413_3d8a7e71-d81d-4ccb-86a7-799b6418104a 37808-413 HUMAN OTC DRUG DANDRUFF SHAMPOO DAILY CLEAN FOR NORMAL HAIR PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20091020 OTC MONOGRAPH FINAL part358 HEB PYRITHIONE ZINC 1 mL/100mL 37808-414_3b262473-ac5e-425f-9b39-d15f8263753f 37808-414 HUMAN OTC DRUG DANDRUFF CONDITIONER DAILY CLEAN FOR NORMAL HAIR PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20091020 OTC MONOGRAPH FINAL part358 HEB PYRITHIONE ZINC .5 mL/100mL 37808-415_87b6e89c-b053-4e48-84ef-f47707f6752a 37808-415 HUMAN OTC DRUG DANDRUFF 2 IN 1 SHAMPOO AND CONDITIONER DAILY CLEAN FOR NORMAL HAIR PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20091020 OTC MONOGRAPH FINAL part358 HEB PYRITHIONE ZINC 1 mL/100mL 37808-416_44d69334-ed46-4d60-b656-51d45c7bebd0 37808-416 HUMAN OTC DRUG DANDRUFF SHAMPOO DRY SCALP RECOVERY PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20091020 OTC MONOGRAPH FINAL part358 HEB PYRITHIONE ZINC 1 mL/100mL 37808-417_3dbd14e2-b54c-4f65-a12e-37ae590470d3 37808-417 HUMAN OTC DRUG DANDRUFF CONDITIONER DRY SCALP RECOVERY PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20091020 OTC MONOGRAPH FINAL part358 HEB PYRITHIONE ZINC .5 mL/100mL 37808-418_f244db1f-cd9e-4a12-aa28-d3c1875fc573 37808-418 HUMAN OTC DRUG DANDRUFF 2 IN 1 SHAMPOO AND CONDITIONER DRY SCALP RECOVERY PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20091020 OTC MONOGRAPH FINAL part358 HEB PYRITHIONE ZINC 1 mL/100mL 37808-419_3ceec403-9632-44cb-a7e2-8858c9598866 37808-419 HUMAN OTC DRUG DANDRUFF 2 IN 1 SHAMPOO AND CONDITIONER SHINY SMOOTH PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20091020 OTC MONOGRAPH FINAL part358 HEB PYRITHIONE ZINC 1 mL/100mL 37808-420_38905abb-4cc0-4cda-a004-adc3c1c27f38 37808-420 HUMAN OTC DRUG Minoxidil regular strength Minoxidil SOLUTION TOPICAL 20110506 ANDA ANDA075357 H E B MINOXIDIL 2 g/100mL 37808-422_ed8e9e59-0df5-466f-a812-a590248086a6 37808-422 HUMAN OTC DRUG In Control Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050615 ANDA ANDA078326 H E B NICOTINE 4 mg/1 37808-423_5b62334b-ffcb-4418-ad4a-fbc249007fc8 37808-423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 HEB IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 37808-424_530448e2-f128-4609-a3e7-01d4b8fe0edf 37808-424 HUMAN OTC DRUG HEB DANDRUFF PYRITHIONE ZINC SHAMPOO TOPICAL 20111223 OTC MONOGRAPH FINAL part358H HEB PYRITHIONE ZINC 1 mL/100mL 37808-425_55af2c65-6db9-4abc-94e6-df88b99dfc60 37808-425 HUMAN OTC DRUG Allergy Relief Fexofenadine HCl TABLET, FILM COATED ORAL 20110824 ANDA ANDA076447 H E B FEXOFENADINE HYDROCHLORIDE 60 mg/1 37808-428_65582a77-2691-457e-b746-357462cf5fe3 37808-428 HUMAN OTC DRUG Rx Act Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20010710 OTC MONOGRAPH FINAL part332 H E B DIMETHICONE 125 mg/1 37808-430_0f8f7d57-81af-4178-9410-8e49be700495 37808-430 HUMAN OTC DRUG Rx Act headache formula added strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19920203 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 37808-431_b72c47a3-cae3-4b98-ae85-e1313b6fd501 37808-431 HUMAN OTC DRUG nighttime sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20091009 OTC MONOGRAPH FINAL part338 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 37808-432_b79c9f87-a499-4242-b01e-b08107ba7a16 37808-432 HUMAN OTC DRUG Rx Act Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 20060213 OTC MONOGRAPH FINAL part341 H E B PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 37808-437_9e6fff23-6549-432d-850a-09a894965d83 37808-437 HUMAN OTC DRUG rx act Pain Relief PM Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19960710 OTC MONOGRAPH FINAL part338 H E B ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 37808-441_e5272b5e-4b57-4ae4-bc15-4d9d016c4c8d 37808-441 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 19980506 ANDA ANDA040167 H E B DOXYLAMINE SUCCINATE 25 mg/1 37808-444_2de32f04-780a-4683-8406-611f62de0fa6 37808-444 HUMAN OTC DRUG flu and severe cold and cough daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20110204 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 37808-445_9cc452ea-f64f-4f98-9aa6-4ee37f9455fd 37808-445 HUMAN OTC DRUG flu and severe cold and cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20140320 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 37808-447_b7799163-c868-4d96-92c5-62d130847e41 37808-447 HUMAN OTC DRUG Childrens Pain Reliever Acetaminophen TABLET, ORALLY DISINTEGRATING ORAL 20050203 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 80 mg/1 37808-450_1f0c4721-0a18-4765-9d4b-12777ba0bbe5 37808-450 HUMAN OTC DRUG Junior Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 160 mg/1 37808-453_27e1a41f-0991-42fc-8c09-27b19e98febf 37808-453 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 H E B PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 37808-455_fb307bc5-cb8b-49ea-878e-980ac5707436 37808-455 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051001 ANDA ANDA075077 H E B ACETAMINOPHEN 650 mg/1 37808-456_f7904b4c-e1ec-4389-a990-6517226d80c8 37808-456 HUMAN OTC DRUG In Control Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061013 ANDA ANDA076777 H E B NICOTINE 2 mg/1 37808-458_7a07a7c9-a4ec-408c-8560-db8fe5b713a9 37808-458 HUMAN OTC DRUG Rx Act all day allergy relief Cetirizine Hydrochloride TABLET ORAL 20080131 ANDA ANDA078336 H E B CETIRIZINE HYDROCHLORIDE 10 mg/1 37808-459_672db2b6-3592-487f-b074-703bd19e4d77 37808-459 HUMAN OTC DRUG night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120204 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 37808-462_f2c2b322-0ac8-47ce-a243-ca617debd297 37808-462 HUMAN OTC DRUG antihistamine allergy diphenhydramine hydrochloride CAPSULE ORAL 19890715 OTC MONOGRAPH FINAL part341 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 37808-463_6623293c-75fa-42f2-8b60-fee714eeb506 37808-463 HUMAN OTC DRUG Allergy Chlorpheniramine Maleate TABLET ORAL 19941012 OTC MONOGRAPH FINAL part341 H E B CHLORPHENIRAMINE MALEATE 4 mg/1 37808-467_a4f737e7-18d6-4b45-89b2-48062911314c 37808-467 HUMAN OTC DRUG Rx Act Aspirin Aspirin TABLET, CHEWABLE ORAL 19970529 OTC MONOGRAPH NOT FINAL part343 H E B ASPIRIN 81 mg/1 37808-468_fdfe2683-ada7-46e9-acb4-81070584ee83 37808-468 HUMAN OTC DRUG Antacid Calcium carbonate TABLET, CHEWABLE ORAL 19970917 OTC MONOGRAPH FINAL part331 H E B CALCIUM CARBONATE 750 mg/1 37808-469_6db3d551-1d0e-4129-958b-d583df3877d8 37808-469 HUMAN OTC DRUG rx act stomach relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 19941108 OTC MONOGRAPH FINAL part335 H E B BISMUTH SUBSALICYLATE 262 mg/1 37808-470_de699d56-9424-4c8d-8e90-b67aef673d2d 37808-470 HUMAN OTC DRUG Day Time Cold Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130830 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 37808-471_25ec9014-64c4-44df-9e67-9f9223ffc923 37808-471 HUMAN OTC DRUG hydrocortisone hydrocortisone OINTMENT TOPICAL 20140118 OTC MONOGRAPH NOT FINAL part348 H E B HYDROCORTISONE 1 g/100g 37808-476_157c907c-427c-4d9f-a107-d1a7bbf068a3 37808-476 HUMAN OTC DRUG Allergy Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20060117 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 37808-477_c8b8c25c-481a-4738-8b5d-eb62cacd20ea 37808-477 HUMAN OTC DRUG fiber laxative Calcium polycarbophil TABLET, FILM COATED ORAL 20011031 OTC MONOGRAPH NOT FINAL part334 H E B CALCIUM POLYCARBOPHIL 625 mg/1 37808-478_4668db19-3c9f-4456-ba9c-412003b40c40 37808-478 HUMAN OTC DRUG Antacid calcium carbonate TABLET, CHEWABLE ORAL 19910615 OTC MONOGRAPH FINAL part331 H E B CALCIUM CARBONATE 500 mg/1 37808-479_3cf592b2-92be-41d2-83d9-51605dce6f2d 37808-479 HUMAN OTC DRUG Antihistamine Allergy Diphenhydramine Hydrochloride TABLET ORAL 19890815 OTC MONOGRAPH FINAL part341 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 37808-480_5ef6e025-5b7a-4d6a-b1fb-e1d7e36d1d3d 37808-480 HUMAN OTC DRUG Night Time Liquid Caps Cold Flu Multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130814 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 37808-484_74448ae1-e55e-453f-9554-696c1ebeb6fb 37808-484 HUMAN OTC DRUG rx act pain relief Acetaminophen TABLET ORAL 19910615 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 500 mg/1 37808-485_7f34c15d-dd24-458a-b531-3bb1d0dcf780 37808-485 HUMAN OTC DRUG antacid calcium carbonate TABLET, CHEWABLE ORAL 19960313 OTC MONOGRAPH FINAL part331 H E B CALCIUM CARBONATE 500 mg/1 37808-490_99dce506-c2c4-4a0a-b07c-d599f68c13ca 37808-490 HUMAN OTC DRUG Rx Act all day pain relief Naproxen Sodium TABLET ORAL 19970224 ANDA ANDA074661 H E B NAPROXEN SODIUM 220 mg/1 37808-491_274366e9-c958-4233-9eff-38619351e71c 37808-491 HUMAN OTC DRUG HEB Radiant White Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 HEB SODIUM FLUORIDE .243 g/100g 37808-495_b2c76f88-e4d4-4936-82dc-988f01df80b8 37808-495 HUMAN OTC DRUG ORCHID SUGAR COOKIE ETHYL ALCOHOL LIQUID TOPICAL 20130912 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 650 mg/mL 37808-498_ad3a71b8-9124-42f8-a25d-cadbb675d721 37808-498 HUMAN OTC DRUG mucus relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130319 ANDA ANDA078912 H E B GUAIFENESIN 600 mg/1 37808-500_6402a5b3-3e29-47aa-a37c-0c54605347c7 37808-500 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 19970224 ANDA ANDA074661 H E B NAPROXEN SODIUM 220 mg/1 37808-501_8ecf4cba-a5fb-48f1-a590-1bb3f468a586 37808-501 HUMAN OTC DRUG nausea relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20141104 UNAPPROVED DRUG OTHER H E B DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 37808-504_bd767497-90a6-4121-8672-4fd523f8942d 37808-504 HUMAN OTC DRUG Tussin Cough Dextromethorphan Hydrobromide LIQUID ORAL 19920505 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 37808-511_fc905e64-d4e5-4614-a431-8b8b537aa371 37808-511 HUMAN OTC DRUG in control nicotine Nicotine Polacrilex LOZENGE ORAL 20140728 ANDA ANDA090821 H E B NICOTINE 4 mg/1 37808-516_c46b8e6a-36e5-43c1-ae10-f1ee5264b56f 37808-516 HUMAN OTC DRUG Rx Act Tussin CF Cough and Cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 19960718 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 37808-517_3a667eb6-cc18-404f-9544-f009188a7805 37808-517 HUMAN OTC DRUG rx act ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060704 ANDA ANDA077349 H E B IBUPROFEN 200 mg/1 37808-519_372d7dea-99d9-4826-a78f-871c41a828e6 37808-519 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20090512 OTC MONOGRAPH FINAL part347 H E B PETROLATUM 100 g/100g 37808-524_e807945d-8dc6-4f70-8a2a-7355c435791e 37808-524 HUMAN OTC DRUG Lice Treatment permethrin LOTION TOPICAL 20010810 ANDA ANDA075014 HEB PERMETHRIN 1 mg/100mL 37808-532_299d2492-f530-4366-a58a-eaf3dd58aa12 37808-532 HUMAN OTC DRUG In Control Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061013 ANDA ANDA076779 H E B NICOTINE 4 mg/1 37808-535_2ec2f9db-3f53-4cd5-a0f1-bce06c675390 37808-535 HUMAN OTC DRUG Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20040803 OTC MONOGRAPH NOT FINAL part343 H E B ASPIRIN 81 mg/1 37808-536_0a5eeef0-309b-4edd-a664-3d9c1c74a6e9 37808-536 HUMAN OTC DRUG bacitracin Bacitracin OINTMENT TOPICAL 19910615 OTC MONOGRAPH FINAL part333B H E B BACITRACIN 500 [USP'U]/g 37808-541_569bf1cd-f186-4c19-96f9-4edc4692e724 37808-541 HUMAN OTC DRUG Hydrocortisone maximum strength Hydrocortisone CREAM TOPICAL 20100823 OTC MONOGRAPH NOT FINAL part348 H E B HYDROCORTISONE 1 g/100g 37808-546_14f187c9-4e82-4c30-82af-0910536b7e17 37808-546 HUMAN OTC DRUG complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080914 ANDA ANDA077355 H E B CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 37808-550_8bcdaf26-bf05-4d97-866d-88b2bd2abecb 37808-550 HUMAN OTC DRUG all day allergy relief Cetirizine Hydrochloride TABLET ORAL 20140208 ANDA ANDA078336 H E B CETIRIZINE HYDROCHLORIDE 10 mg/1 37808-552_8ecbfd81-fe45-49b4-b835-a32192de8f53 37808-552 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20140501 ANDA ANDA075232 H E B LOPERAMIDE HYDROCHLORIDE 2 mg/1 37808-556_60b95759-629b-4ad4-a75f-00c93305d387 37808-556 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl CAPSULE ORAL 20071217 OTC MONOGRAPH NOT FINAL part341 H E B ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 37808-566_9d9b3d68-0e21-4d0e-b515-b6d32e3f05b0 37808-566 HUMAN OTC DRUG sinus congestion and pain daytime non drowsy Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20070129 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 37808-571_9eb6e74f-f221-4033-bc84-e9f12ffc7c83 37808-571 HUMAN OTC DRUG Allergy Relief fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110622 ANDA ANDA076447 H E B FEXOFENADINE HYDROCHLORIDE 180 mg/1 37808-578_50a1110d-22b6-46e8-9cd7-66f19fc81873 37808-578 HUMAN OTC DRUG tussin dm Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20060530 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 37808-595_4b082f03-2998-42d7-b382-2fe5f7600b9e 37808-595 HUMAN OTC DRUG Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 19951114 OTC MONOGRAPH FINAL part331 H E B CALCIUM CARBONATE 1000 mg/1 37808-600_60cd6a7a-618a-46bc-b81d-60434990c362 37808-600 HUMAN OTC DRUG Aspirin 81 mg Aspirin TABLET, COATED ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 H E B ASPIRIN 81 mg/1 37808-601_b77a84d8-9acd-4d53-8741-01d670ffae4b 37808-601 HUMAN OTC DRUG Tussin Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20141023 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 37808-604_a340ed68-debb-4c1e-97eb-82f6e9e3854f 37808-604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19890215 ANDA ANDA072096 H E B IBUPROFEN 200 mg/1 37808-608_5d13e07c-0708-4aee-9417-029f672313e2 37808-608 HUMAN OTC DRUG naproxen sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20110104 NDA NDA021920 H E B NAPROXEN SODIUM 220 mg/1 37808-613_868e3505-5e6b-4d6d-8129-92523e41ff58 37808-613 HUMAN OTC DRUG HEB Dandruff Selenium Sulfide SHAMPOO TOPICAL 20110808 OTC MONOGRAPH FINAL part358H H E B SELENIUM SULFIDE 1 mL/100mL 37808-615_84209323-9d32-4150-a603-a8b028d66fce 37808-615 HUMAN OTC DRUG itchy eye Ketotifen SOLUTION OPHTHALMIC 20100915 ANDA ANDA077958 H E B KETOTIFEN FUMARATE .25 mg/mL 37808-622_34c7bcd3-203f-4630-894d-3739a1576c8d 37808-622 HUMAN OTC DRUG itch relief Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part348 H E B DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 37808-637_1ed01f1f-9a4a-40ac-b4ae-813a197a68c8 37808-637 HUMAN OTC DRUG Eye Lubricant polyethylene glycol, propylene glycol LIQUID OPHTHALMIC 20121205 OTC MONOGRAPH FINAL part349 H E B POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/15mL; mg/15mL 37808-645_875a2d88-11c1-4ff8-bbf5-30d6536f82c6 37808-645 HUMAN OTC DRUG Loperamide Hydrochloride loperamide HCl SUSPENSION ORAL 20120305 ANDA ANDA091292 H E B LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 37808-647_e00acbc0-352e-4ba1-8433-18a3079f6743 37808-647 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 19910809 ANDA ANDA072096 H E B IBUPROFEN 200 mg/1 37808-648_42c9b87e-b883-446e-9c24-9d8009b27809 37808-648 HUMAN OTC DRUG Rx Act nasal four Phenylephrine hydrochloride SPRAY NASAL 20100924 OTC MONOGRAPH FINAL part341 H E B PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 37808-656_42bf5094-f78a-4207-8dc8-e67f4015e919 37808-656 HUMAN OTC DRUG DayTime acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20060802 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 37808-660_41b08f75-c1d6-4151-9ff7-a9725d35f37c 37808-660 HUMAN OTC DRUG Rx Act Ibuprofen Ibuprofen SUSPENSION ORAL 20020619 ANDA ANDA074937 H E B IBUPROFEN 100 mg/5mL 37808-666_6ec21d8c-cc2b-4e7c-9d08-d9665bbd36e7 37808-666 HUMAN OTC DRUG rx act cough and sore throat Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20060704 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 37808-668_5c5676f5-13a5-4a76-8755-c0f3e5dc2820 37808-668 HUMAN OTC DRUG night time cough relief Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20030225 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 37808-678_b72c91b4-f448-4e0a-b1eb-24daa513177c 37808-678 HUMAN OTC DRUG hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20121216 OTC MONOGRAPH FINAL part346 H E B MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 37808-679_5fb57e68-ec99-4e0f-93a9-9b2061d49ab8 37808-679 HUMAN OTC DRUG triple antibiotic plus maximum strength Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20101105 OTC MONOGRAPH FINAL part333B H E B BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 37808-686_69c0fc59-e0cf-41b3-b9a6-9ae41559ce4c 37808-686 HUMAN OTC DRUG Risk Force Invisible Solid Antiperspirant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20110203 OTC MONOGRAPH FINAL part350 H-E-B ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17.3 g/100g 37808-687_d47657ca-9a1a-4eb2-957d-28a1d3ff0922 37808-687 HUMAN OTC DRUG Risk Friction Invisible Solid Antiperspirant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20110205 OTC MONOGRAPH FINAL part350 H-E-B ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17.3 g/100g 37808-688_54e568a7-9cce-4bb8-af10-8d0ed5b514bb 37808-688 HUMAN OTC DRUG Risk Seduction Invisible Solid Antiperspirant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20110206 OTC MONOGRAPH FINAL part350 H-E-B ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17.3 g/100g 37808-689_2fe9fef3-7d0e-49f0-95a9-2e9e34043098 37808-689 HUMAN OTC DRUG Risk True Invisible Solid Antiperspirant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20110207 OTC MONOGRAPH FINAL part350 H-E-B ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17.3 g/100g 37808-690_96ca656b-afa5-466f-95c0-11b607c7aa52 37808-690 HUMAN OTC DRUG Antihistamine Allergy Diphenhydramine Hydrochloride TABLET ORAL 20111201 OTC MONOGRAPH FINAL part336 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 37808-693_303646c6-76cc-4200-b327-ebdf75019740 37808-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20130227 OTC MONOGRAPH NOT FINAL part334 HEB MAGNESIUM CITRATE 1.745 g/29.6mL 37808-698_674ed1bc-4db6-4892-90f8-74cd3a317a12 37808-698 HUMAN OTC DRUG rx act cough and sore throat Acetaminophen, Dextromethorphan HBr LIQUID ORAL 20060828 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 500; 15 mg/15mL; mg/15mL 37808-700_2a859e85-77a9-44af-84d8-b814de7a5025 37808-700 HUMAN OTC DRUG pain relief extra strength Acetaminophen CAPSULE, COATED ORAL 20110321 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 500 mg/1 37808-702_2bf3cfe0-2fde-492c-949d-47d1268ff944 37808-702 HUMAN OTC DRUG Day Time Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20130121 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 37808-706_aba44277-11f9-40a8-a148-4a2f98f1201f 37808-706 HUMAN OTC DRUG Gas Relief Infants Simethicone EMULSION ORAL 20081011 OTC MONOGRAPH FINAL part332 H E B DIMETHICONE 20 mg/.3mL 37808-709_21567c0f-abba-4a40-a0b9-5ce49b3d9648 37808-709 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060704 ANDA ANDA077349 H E B IBUPROFEN 200 mg/1 37808-720_c559d21f-dab6-48fd-a128-5cca54c78d53 37808-720 HUMAN OTC DRUG ANTIBACTERIAL HAND SOAP FOR SENSITIVE SKIN TRICLOSAN LOTION/SHAMPOO TOPICAL 20100308 OTC MONOGRAPH NOT FINAL part333 HEB TRICLOSAN .115 mL/100mL 37808-721_5cf45772-603a-4ad0-89d6-c8cedba7dc47 37808-721 HUMAN OTC DRUG HILL COUNTRY ESSENTIALS ANTIBACTERIAL HAND BENZALKONIUM CHLORIDE LIQUID TOPICAL 20141209 OTC MONOGRAPH NOT FINAL part333E H E B BENZALKONIUM CHLORIDE 1.3 mg/mL 37808-724_06bf74f1-cf33-45ee-8463-c2a8e535fd6e 37808-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 HEB LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 37808-734_4d014ed9-3b90-46a6-b07c-828aa820eaa4 37808-734 HUMAN OTC DRUG in control nicotine Nicotine Polacrilex LOZENGE ORAL 20140723 ANDA ANDA203690 H E B NICOTINE 2 mg/1 37808-737_775f8443-c6cf-481b-a0d2-b0fda6d2701a 37808-737 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100607 ANDA ANDA079114 H E B 37808-742_c152a8cb-cefd-4560-b5c2-5a02478d0b0e 37808-742 HUMAN OTC DRUG rx act naproxen sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20110104 NDA NDA021920 H E B NAPROXEN SODIUM 220 mg/1 37808-751_dae86831-972b-4a2a-8512-dbe2d252ab36 37808-751 HUMAN OTC DRUG pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120521 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 37808-759_4fe703ad-0b07-49ae-a2df-99557bbff2d3 37808-759 HUMAN OTC DRUG pain relief Acetaminophen SUSPENSION ORAL 20110301 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 160 mg/5mL 37808-771_1ce16f5a-01e9-4647-bfdc-b7cb9d517380 37808-771 HUMAN OTC DRUG Muscle Rub Greaseless Menthol, methyl salicylate CREAM TOPICAL 20110725 OTC MONOGRAPH NOT FINAL part348 H E B MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g 37808-773_408abbff-3a5b-42ea-b3d2-69c4ff7c417a 37808-773 HUMAN OTC DRUG Muscle Rub Ultra Camphor,Menthol, methyl salicylate CREAM TOPICAL 20110725 OTC MONOGRAPH NOT FINAL part348 H E B CAMPHOR (NATURAL); MENTHOL; MENTHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g 37808-798_572dab2e-8762-4f6a-a28b-ceda0eb968cf 37808-798 HUMAN OTC DRUG minoxidil for men Minoxidil SOLUTION TOPICAL 20100216 ANDA ANDA075598 H E B MINOXIDIL 3 g/60mL 37808-800_48b4b2cb-42b0-4101-a2a1-8c43b6bd10e9 37808-800 HUMAN OTC DRUG Cold and Cough Acetaminophen, Dextromethorphan HBr LIQUID ORAL 20140331 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 500; 15 mg/15mL; mg/15mL 37808-801_c517487e-537d-4454-bbde-b82e49af1395 37808-801 HUMAN OTC DRUG Clean and Refresh Body Wash Moisturizing Triclosan SOAP TOPICAL 20100922 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .15 mL/100mL 37808-802_886d4765-562c-49ee-a2b3-da864f58195f 37808-802 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140225 ANDA ANDA077958 H E B KETOTIFEN FUMARATE .35 mg/mL 37808-806_309adc66-f625-4825-819b-9688ccee8627 37808-806 HUMAN OTC DRUG HILL COUNTRY ESSENTIALS LAVENDER AND JASMINE TRICLOSAN LIQUID TOPICAL 20130404 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN 1.5 mg/mL 37808-807_dc166807-2c00-4c56-bb3a-d36a6a956b4a 37808-807 HUMAN OTC DRUG Flu and Severe Cold and Cough Nighttime Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20100922 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 37808-809_b1b41228-2bc4-4170-a107-520c1bb7f72e 37808-809 HUMAN OTC DRUG inControl alcohol Isopropyl Alcohol SWAB TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part333A H E B ISOPROPYL ALCOHOL 70 mL/100mL 37808-817_407b0c4e-f839-4f00-8d7f-6c7a00222bb4 37808-817 HUMAN OTC DRUG rx act nasal sinus oxymetazoline hydrochloride SPRAY NASAL 20000825 OTC MONOGRAPH FINAL part341 H E B OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 37808-818_536b1038-125d-4532-ba07-a4d7a09368a8 37808-818 HUMAN OTC DRUG daytime Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20110301 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/15mL; mg/15mL 37808-819_d63df69a-5dab-46ab-aad7-0559ca857f53 37808-819 HUMAN OTC DRUG Minoxidil regular strength Minoxidil SOLUTION TOPICAL 20061109 ANDA ANDA075357 H E B MINOXIDIL 2 g/100mL 37808-825_9741b8c0-716a-4c54-9793-387866faf766 37808-825 HUMAN OTC DRUG miconazole 7 Miconazole nitrate CREAM VAGINAL 20060109 ANDA ANDA074760 H E B MICONAZOLE NITRATE 2 g/100g 37808-829_2b7b8774-20b7-4a3a-bbb4-f30148f92ccf 37808-829 HUMAN OTC DRUG rx act pain relief pm extra strengh rapid release Acetaminophen, Diphenhydramine HCl CAPSULE, COATED ORAL 20100826 OTC MONOGRAPH FINAL part338 H E B ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 37808-843_1888cd0d-38fb-49cc-8c10-6dab3cf82ef2 37808-843 HUMAN OTC DRUG hemorrhoidal Phenylephrine HCl, Witch hazel GEL TOPICAL 20110325 OTC MONOGRAPH FINAL part346 H E B PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/100g; g/100g 37808-851_0fd92624-6e84-4d1a-be71-8fb61aecdbd6 37808-851 HUMAN OTC DRUG antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20021112 OTC MONOGRAPH FINAL part332 H E B ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 37808-852_8bab81f0-758b-422d-9ff3-597453006445 37808-852 HUMAN OTC DRUG Heartburn Relief Ranitidine TABLET, FILM COATED ORAL 20130723 ANDA ANDA091429 H E B RANITIDINE HYDROCHLORIDE 150 mg/1 37808-854_7a6d0183-5e80-4753-ad4b-50b11da68b05 37808-854 HUMAN OTC DRUG In Control Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20071213 ANDA ANDA078546 H E B NICOTINE 4 mg/1 37808-861_64accd4a-9481-4cc8-902a-5497c01fb37a 37808-861 HUMAN OTC DRUG HEB Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 HEB POTASSIUM NITRATE; SODIUM FLUORIDE 5; 1.5 g/g; g/g 37808-870_193096a5-dbd5-4a89-aa75-332c43001ed1 37808-870 HUMAN OTC DRUG Allergy Eye Drops Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140225 ANDA ANDA077958 H E B KETOTIFEN FUMARATE .35 mg/mL 37808-873_4ed67d21-9449-4f6e-9827-9444617e5d64 37808-873 HUMAN OTC DRUG in control nicotine Nicotine Polacrilex LOZENGE ORAL 20070725 ANDA ANDA077007 H E B NICOTINE 4 mg/1 37808-880_742dec31-e6ee-4705-8cad-6b0a72b5ecb9 37808-880 HUMAN OTC DRUG rx act antacid extra strength Aluminum hydroxide, Magnesium carbonate TABLET, CHEWABLE ORAL 19970312 OTC MONOGRAPH FINAL part331 H E B ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 37808-882_03097aa6-b255-4ca8-acf6-9813c42d3251 37808-882 HUMAN OTC DRUG rx act gas relief infants Simethicone EMULSION ORAL 20081011 OTC MONOGRAPH FINAL part332 H E B DIMETHICONE 20 mg/.3mL 37808-884_f804c126-e64f-4379-853c-51b7bc793e31 37808-884 HUMAN OTC DRUG CHILDRENS ALLERGY cetirizine Hydrochloride LIQUID ORAL 20101101 ANDA ANDA090254 H E B CETIRIZINE HYDROCHLORIDE 5 mg/5mL 37808-885_723ba6de-07e4-411d-9272-3fafbf0bd1c6 37808-885 HUMAN OTC DRUG hydrocortisone Hydrocortisone GEL TOPICAL 20101002 OTC MONOGRAPH NOT FINAL part348 H E B HYDROCORTISONE 1 g/100g 37808-896_cfb5cc6b-0c5e-4d9f-a3a2-a6b6e23aef2a 37808-896 HUMAN OTC DRUG HEB Brilliant White Fluoride PASTE, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part355 HEB SODIUM MONOFLUOROPHOSPHATE .76 g/100g 37808-897_c2943fac-ced4-484b-abb4-83f5d5e88ef7 37808-897 HUMAN OTC DRUG rx act ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990106 ANDA ANDA074937 H E B IBUPROFEN 100 mg/5mL 37808-902_7a1dfd84-9340-48f1-ac0a-99e0e998e0a2 37808-902 HUMAN OTC DRUG Cold and Cough Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate SOLUTION ORAL 20140714 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 37808-906_eb930973-338c-4b49-a3c0-064eea283a29 37808-906 HUMAN OTC DRUG rx act cold and allergy childrens phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20061016 OTC MONOGRAPH FINAL part341 H E B BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 37808-915_5df6b40b-9a1d-4d0e-a786-7e2b85d58954 37808-915 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080229 NDA NDA022032 H E B OMEPRAZOLE 20 mg/1 37808-917_6ca310a4-31a2-4fe8-bf0d-b2c9c4b86766 37808-917 HUMAN OTC DRUG Rx Act pain relief extra strength Acetaminophen CAPSULE, COATED ORAL 20110321 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 500 mg/1 37808-921_deab5b5b-6847-4f03-8b42-75030736895e 37808-921 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 H E B IBUPROFEN 200 mg/1 37808-922_a87c9a68-91a0-4bbd-ad55-909e8288c727 37808-922 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, COATED ORAL 19880524 ANDA ANDA075010 H E B IBUPROFEN 200 mg/1 37808-923_9d1bc621-e446-49ec-8140-4332d894b83d 37808-923 HUMAN OTC DRUG eye itch relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20100910 ANDA ANDA077958 H E B KETOTIFEN FUMARATE .25 mg/mL 37808-929_573ecac6-23c1-4ea5-8d34-a3cbb7dc446c 37808-929 HUMAN OTC DRUG Hydrocortisone Hydrocortisone Acetate OINTMENT TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part348 H E B HYDROCORTISONE ACETATE 1 g/100g 37808-944_e9d54c86-dee1-44c9-a340-29c68a8b96cf 37808-944 HUMAN OTC DRUG hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20121025 OTC MONOGRAPH FINAL part346 H E B GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g 37808-946_945141f7-5059-421b-8185-f8a2192b3814 37808-946 HUMAN OTC DRUG pain and fever Acetaminophen SUSPENSION ORAL 20111201 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 160 mg/5mL 37808-949_90fcb510-be76-45b3-8fdc-33e796a75e96 37808-949 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide LIQUID ORAL 20121010 OTC MONOGRAPH NOT FINAL part334 H E B MAGNESIUM HYDROXIDE 1200 mg/15mL 37808-950_1835a1fa-7284-425b-abf0-179ee427e2ae 37808-950 HUMAN OTC DRUG heartburn relief Ranitidine TABLET, FILM COATED ORAL 20111125 ANDA ANDA091429 H E B RANITIDINE HYDROCHLORIDE 150 mg/1 37808-957_6b79aa1f-3349-4359-a6ea-da03c88dd08d 37808-957 HUMAN OTC DRUG in control nicotine Nicotine Polacrilex LOZENGE ORAL 20140723 ANDA ANDA203690 H E B NICOTINE 4 mg/1 37808-961_4c7ffb19-50fa-4174-875d-9c9f28e1d058 37808-961 HUMAN OTC DRUG HEB Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 HEB POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 37808-964_f6242ac7-0855-4603-a640-8efb8bee0cd2 37808-964 HUMAN OTC DRUG rx act flu and severe cold and cough nighttime Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20100922 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 37808-966_067eb4ad-b01e-4ebb-8405-37f376594450 37808-966 HUMAN OTC DRUG ORCHID BY H E B JASMINE TEA AND BASIL ETHYL ALCOHOL LIQUID TOPICAL 20140602 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 620 mg/mL 37808-970_63f053f3-6124-43ac-bf22-69c4f7b08754 37808-970 HUMAN OTC DRUG Antihistamine Allergy Diphenhydramine HCl CAPSULE ORAL 20110323 OTC MONOGRAPH FINAL part336 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 37808-973_412ca2d1-064b-4438-aee1-fcb5cf27c7db 37808-973 HUMAN OTC DRUG hydrocortisone hydrocortisone CREAM TOPICAL 20100927 OTC MONOGRAPH NOT FINAL part348 H E B HYDROCORTISONE 1 g/100g 37808-977_62ca525f-76d9-4e3f-9650-9a5a930204a7 37808-977 HUMAN OTC DRUG rx act nighttime cold flu relief multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20110610 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 37808-980_48a6ec2a-d608-4509-bb30-b36f347800c3 37808-980 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET ORAL 19910615 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 500 mg/1 37808-987_404ef5f4-7b7b-4c08-b159-9175a91be132 37808-987 HUMAN OTC DRUG cold and cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20060921 OTC MONOGRAPH FINAL part341 H E B BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 37808-994_40a98653-40f3-4f3d-8409-9ce26ec51218 37808-994 HUMAN OTC DRUG day time Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20110727 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 37929-000_1f6342b8-3de5-4596-b023-a6d139def0ce 37929-000 HUMAN OTC DRUG Med-I-San Alkyl (68% C12, 32% C14) Dimethyl Ethylbenzyl Ammonium Chloride and Alkyl Dimethyl Benzyl Ammonium Chloride SOAP TOPICAL 20140320 OTC MONOGRAPH NOT FINAL part333A Daley International BENZALKONIUM CHLORIDE; N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) 12.5; 12.5 mg/mL; mg/mL 37929-001_a6fd3514-0642-459b-9933-3dc98db69263 37929-001 HUMAN OTC DRUG Foamy Med-I-San Alkyl (68% C12, 32% C14) Dimethyl Ethylbenzyl Ammonium Chloride and Alkyl Dimethyl Benzyl Ammonium Chloride SOAP TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part333A Daley International BENZALKONIUM CHLORIDE; N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) 14; 14 mg/mL; mg/mL 37945-868_05f4db7a-c087-2b78-e054-00144ff88e88 37945-868 HUMAN OTC DRUG Pro-Tect Everyday Sunscreen SPF 15 Octinoxate, Octisalate, Padimate O LOTION TOPICAL 19871201 OTC MONOGRAPH NOT FINAL part352 Bio-Medical & Pharmaceutical Manufacturing Corporation OCTINOXATE; OXYBENZONE; PADIMATE O 75; 20; 50 mg/g; mg/g; mg/g 37945-870_060e341a-c8fd-3746-e054-00144ff8d46c 37945-870 HUMAN OTC DRUG Kleer-Plex Foaming Acne Clarifier Salicylic Acid LIQUID TOPICAL 20141022 OTC MONOGRAPH FINAL part333D Bio-Medical & Pharmaceutical Manufacturing Corporation SALICYLIC ACID 20 mg/mL 37945-874_060e341a-c8ef-3746-e054-00144ff8d46c 37945-874 HUMAN OTC DRUG Kleer-Plex Penetrating Acne SALICYLIC ACID GEL TOPICAL 20141022 OTC MONOGRAPH FINAL part333D Bio-Medical & Pharmaceutical Manufacturing Corporation SALICYLIC ACID 20 mg/mL 37945-876_25c82c9e-09aa-4486-8fa0-a9fb4cd494ba 37945-876 HUMAN OTC DRUG Kleer-Plex Advanced Acne Care System Salicylic Acid KIT 20141103 OTC MONOGRAPH FINAL part333D Bio-Medical & Pharmaceutical Manufacturing Corporation 37945-894_060e3c63-afdb-11c3-e054-00144ff88e88 37945-894 HUMAN OTC DRUG Kleer-Plex Targeted Acne Pen Salicylic Acid GEL TOPICAL 20141022 OTC MONOGRAPH FINAL part333D Bio-Medical & Pharmaceutical Manufacturing Corporation SALICYLIC ACID 20 mg/mL 38755-0111_42ba124d-14a1-4ad0-8c24-6995235cd0d6 38755-0111 HUMAN OTC DRUG Oily Hair Dandruff Zerran International Zinc Pyrithione CREAM TOPICAL 20100715 OTC MONOGRAPH FINAL part358H Zerran International Corporation PYRITHIONE ZINC 1 mL/100mL 39313-001_235e93fe-e997-4403-9666-4b79dd90204c 39313-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19720101 UNAPPROVED MEDICAL GAS Middlesex Welding Sales Co, Inc. OXYGEN 99 L/100L 39313-006_9eb44709-814e-4ce4-900f-07882c44ca0d 39313-006 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19720101 UNAPPROVED MEDICAL GAS Middlesex Welding Sales Co, Inc. NITROGEN 99 L/100L 39328-047_44e1d713-12e4-4050-8968-49fbdedd32dd 39328-047 HUMAN PRESCRIPTION DRUG Hyoscyamine Hyoscyamine Sulfate LIQUID ORAL 20110904 UNAPPROVED DRUG OTHER Patrin Pharma HYOSCYAMINE SULFATE .125 mg/mL 39328-048_e4d3bee8-e9c8-4e76-86aa-3bd6256292c5 39328-048 HUMAN PRESCRIPTION DRUG Hyoscyamine Hyoscyamine Sulfate LIQUID ORAL 20110904 UNAPPROVED DRUG OTHER Patrin Pharma HYOSCYAMINE SULFATE .125 mg/5mL 39328-106_59c5c1a4-3f42-441a-b842-903f9bab346f 39328-106 HUMAN PRESCRIPTION DRUG Prenatal Vitamins Plus Low Iron Prenatal with Ferrous Fum and Folic Acid TABLET ORAL 20130401 UNAPPROVED DRUG OTHER Patrin Pharma, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BETA CAROTENE; CALCIUM CARBONATE; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE; VITAMIN A ACETATE; ZINC 22; 120; 920; 200; 400; 2; 12; 1; 27; 20; 10; 3; 1.84; 3080; 25 mg/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 39338-1072_47f18e24-789c-4b3e-b116-4e797f5c143a 39338-1072 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070717 UNAPPROVED MEDICAL GAS Yosemite Medical Supply OXYGEN 99 L/100L 39765-001_7b282bd0-b2dd-4ebc-b15b-3f12f79342bb 39765-001 HUMAN OTC DRUG Heeltastic DIMETHICONE AND TOLNAFTATE STICK TOPICAL 20090630 OTC MONOGRAPH FINAL part333C Neutraderm, Inc. DIMETHICONE; TOLNAFTATE 1; 1 g/100g; g/100g 39765-002_4bbac0f2-2a4b-420e-b548-d5b2dd88635b 39765-002 HUMAN OTC DRUG HQRA-OTC Hydroquinone CREAM TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part358A Neutraderm Inc HYDROQUINONE 2 g/100g 39765-003_f05d6c34-32f4-47fe-b226-345ec73e9d0b 39765-003 HUMAN OTC DRUG SPF-60 Octinoxate, Oxybenzone, Octocrylene, Avobenzone CREAM TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part352 Neutraderm, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3; 5; 4; 5 g/100g; g/100g; g/100g; g/100g 39765-004_8c5d72ee-ff70-4315-83b6-2ddf0b9852b3 39765-004 HUMAN OTC DRUG Daily Wear Moisturizer SPF-20 Octinoxate, Octocrylene, Oxybenzone, Avobenzone CREAM TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Neutraderm, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 2.5; 6; 5; 3 g/100g; g/100g; g/100g; g/100g 39765-005_a3418eb4-456f-4b65-95f4-ca9df5a5fbd4 39765-005 HUMAN OTC DRUG Acne Control Serum Benzoyl Peroxide GEL TOPICAL 20100701 OTC MONOGRAPH FINAL part333D Neutraderm, Inc. BENZOYL PEROXIDE 5 mL/100mL 39765-007_4effb961-86f9-4b5b-886c-59bf59b2bedf 39765-007 HUMAN OTC DRUG Clarifying Cleanser Salicylic Acid LIQUID TOPICAL 20100801 OTC MONOGRAPH FINAL part333D Neutraderm, Inc. SALICYLIC ACID 2 mL/100mL 39822-0151_e8f8e69f-2505-4832-b3f5-8827448c983d 39822-0151 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium INJECTION, SOLUTION INTRAVENOUS 20050817 ANDA ANDA076923 X-GEN Pharmaceuticals, Inc. LIOTHYRONINE SODIUM 10 ug/mL l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 39822-0166_c6c206e1-aba9-4e54-b95c-58fbd0d0d597 39822-0166 HUMAN PRESCRIPTION DRUG Polymyxin B Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 19940930 ANDA ANDA063000 X-GEN Pharmaceuticals, Inc. POLYMYXIN B SULFATE 500000 [USP&apos'U]/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 39822-0170_c6f9e088-644b-484d-aaf2-980fec28e89f 39822-0170 HUMAN PRESCRIPTION DRUG Polymyxin B Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 20140115 ANDA ANDA202766 X-GEN Pharmaceuticals, Inc. POLYMYXIN B SULFATE 500000 [USP'U]/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 39822-0171_de7fc64d-5081-4b24-8cc9-d11fe26e1c43 39822-0171 HUMAN PRESCRIPTION DRUG Polymyxin B Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140425 ANDA ANDA202766 X-GEN Pharmaceuticals, Inc. POLYMYXIN B SULFATE 500000 [USP'U]/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 39822-0190_a52553bf-6553-4aef-a8a8-e856b8f2c505 39822-0190 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081210 ANDA ANDA040784 X-GEN Pharmaceuticals, Inc. ACETAZOLAMIDE SODIUM 500 mg/5mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 39822-0191_b332fd0a-8b04-4d3b-bcd2-4b214d847708 39822-0191 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20131210 ANDA ANDA040784 X-GEN Pharmaceuticals, Inc. ACETAZOLAMIDE SODIUM 500 mg/5mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 39822-0205_c84a31cb-4818-40d1-859c-fb544ea0e738 39822-0205 HUMAN PRESCRIPTION DRUG PANCRELIPASE pancrelipase CAPSULE, DELAYED RELEASE ORAL 20090922 NDA AUTHORIZED GENERIC NDA022210 X-GEN Pharmaceuticals, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 27000; 5000; 17000 [USP'U]/1; [USP'U]/1; [USP'U]/1 39822-0277_1d6c7674-5b66-49ee-9552-ed203f1e7e5c 39822-0277 HUMAN PRESCRIPTION DRUG BACiiM Bacitracin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 19970509 ANDA ANDA064153 X-GEN Pharmaceuticals, Inc. BACITRACIN 50000 [USP'U]/1 Decreased Cell Wall Synthesis & Repair [PE] 39822-0310_b0440d67-b433-40e3-a101-50146a93ae76 39822-0310 HUMAN PRESCRIPTION DRUG Neomycin Sulfate Neomycin Sulfate TABLET ORAL 20100312 ANDA ANDA065220 X-GEN Pharmaceuticals, Inc. NEOMYCIN SULFATE 500 mg/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 39822-0330_3010aa62-7af6-438a-bbde-80d41975b8aa 39822-0330 HUMAN PRESCRIPTION DRUG Neo-Fradin Neomycin Sulfate SOLUTION ORAL 20020523 ANDA ANDA065010 X-GEN Pharmaceuticals, Inc. NEOMYCIN SULFATE 87.5 mg/5mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 39822-0409_ea97f4db-93ed-4d81-8996-b2a61edaf07e 39822-0409 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010817 ANDA ANDA065013 X-GEN Pharmaceuticals, Inc. TOBRAMYCIN SULFATE 1.2 g/30mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 39822-0412_dc2f60a4-4c85-4378-9652-b53cfe3f3f88 39822-0412 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010817 ANDA ANDA065013 X-GEN Pharmaceuticals, Inc. TOBRAMYCIN SULFATE 1.2 g/30mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 39822-0615_4c3047ca-ec57-4354-968b-b85c4bfd5e1a 39822-0615 HUMAN PRESCRIPTION DRUG Colistimethate Colistimethate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110101 ANDA ANDA064216 X-GEN Pharmaceuticals, Inc. COLISTIMETHATE SODIUM 150 mg/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 39822-0706_061a6d1c-2095-4a31-97d8-36b144d6ed4f 39822-0706 HUMAN PRESCRIPTION DRUG Streptomycin Streptomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 19980630 ANDA ANDA064210 X-GEN Pharmaceuticals, Inc. STREPTOMYCIN SULFATE 1 g/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Antimycobacterial [EPC] 39822-0710_9cb42975-2237-47c5-a188-6336459365c5 39822-0710 HUMAN PRESCRIPTION DRUG fomepizole fomepizole INJECTION, SOLUTION INTRAVENOUS 20071214 ANDA ANDA078368 X-GEN Pharmaceuticals, Inc. FOMEPIZOLE 1 g/mL Antidote [EPC] 39822-1000_1547dcbf-18c7-4cf3-8bf4-57a19313d06f 39822-1000 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20120518 ANDA ANDA201580 X-GEN Pharmaceuticals, Inc. TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 39822-1001_3736be47-a8b2-492f-b9a1-978b2f77f899 39822-1001 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20120518 ANDA ANDA201580 X-GEN Pharmaceuticals, Inc. TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 39822-1055_234d7e4f-dc71-488d-a694-aec1775496aa 39822-1055 HUMAN PRESCRIPTION DRUG Amphotericin B Amphotericin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19920429 ANDA ANDA063206 X-GEN Pharmaceuticals, Inc. AMPHOTERICIN B 50 mg/10mL Lipid-based Polyene Antifungal [EPC],Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 39822-1201_4b1aeae0-e0a0-442f-b890-6f38ae68c7af 39822-1201 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates Neomycin and Polymyxin B Sulfates SOLUTION IRRIGATION 20060119 ANDA ANDA065106 X-GEN Pharmaceuticals, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE 40; 200000 mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 39822-1220_4b1aeae0-e0a0-442f-b890-6f38ae68c7af 39822-1220 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates Neomycin and Polymyxin B Sulfates SOLUTION IRRIGATION 20060131 ANDA ANDA065108 X-GEN Pharmaceuticals, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE 40; 200000 mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 39822-2000_6a8e9f43-993b-4454-85b2-d1e340d3ef6e 39822-2000 HUMAN PRESCRIPTION DRUG Clonidine Clonidine INJECTION, SOLUTION EPIDURAL 20131029 ANDA ANDA203167 X-GEN Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 39822-2010_6a8e9f43-993b-4454-85b2-d1e340d3ef6e 39822-2010 HUMAN PRESCRIPTION DRUG Clonidine Clonidine INJECTION, SOLUTION EPIDURAL 20131029 ANDA ANDA203167 X-GEN Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE 500 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 39822-3015_b3b835d5-fd0b-422c-94cf-6abd3f05be36 39822-3015 HUMAN PRESCRIPTION DRUG Nystatin Nystatin POWDER TOPICAL 20040830 ANDA ANDA065175 X-GEN Pharmaceuticals, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 39822-4000_d1f0800f-2425-4ce9-9bdb-176573bdfc1b 39822-4000 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20110831 ANDA ANDA091485 X-GEN Pharmaceuticals, Inc. LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 39822-4050_492a8728-d60f-41ea-bedd-ead7375f3ad5 39822-4050 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110502 ANDA ANDA040573 X-GEN Pharmaceuticals, Inc. PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 39822-4200_1ade7720-4d3f-497c-b950-30a985c21beb 39822-4200 HUMAN PRESCRIPTION DRUG rocuronium bromide rocuronium bromide SOLUTION INTRAVENOUS 20121201 ANDA ANDA091115 X-GEN Pharmaceuticals, Inc. ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 39822-5500_03a4839b-041e-46fb-bde3-489cdc5f530d 39822-5500 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110502 ANDA ANDA040737 X-GEN Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 39822-9900_b6c2d3ed-42b6-4cb0-94b3-0a423572578c 39822-9900 HUMAN PRESCRIPTION DRUG Ammonia Inhalants Ammonia Inhalants INHALANT RESPIRATORY (INHALATION) 19760214 UNAPPROVED DRUG OTHER X-GEN Pharmaceuticals, Inc. AMMONIA .045 g/.3mL 39892-0100_9efb167d-9253-4e91-97cb-fb7b740d93d7 39892-0100 HUMAN OTC DRUG MediChoice Antiseptic Isopropyl Alcohol Prep Pads ISOPROPYL ALCOHOL SWAB TOPICAL 20120920 OTC MONOGRAPH NOT FINAL part333A Owens & Minor, Inc ISOPROPYL ALCOHOL 70 mL/100mL 39892-0301_aa10065e-d233-458d-abbc-2943c937d11e 39892-0301 HUMAN OTC DRUG MediChoice BZK Antiseptic Towelette BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130619 OTC MONOGRAPH NOT FINAL part333A Owens and Minor BENZALKONIUM CHLORIDE .13 mg/100mg 39892-0302_da32d16d-d134-4f01-ab24-464e3590ee8f 39892-0302 HUMAN OTC DRUG MediChoice Cleansing Towelette BENZALKONIUM CHLORIDE LIQUID TOPICAL 20141111 OTC MONOGRAPH NOT FINAL part333A Owens and Minor BENZALKONIUM CHLORIDE .13 mg/100mg 39892-0303_553a5e99-ac2f-4fe5-a432-141b8a1b9bee 39892-0303 HUMAN OTC DRUG MediChoice OB Cleansing Towelette BENZALKONIUM CHLORIDE LIQUID TOPICAL 20141111 OTC MONOGRAPH NOT FINAL part333A Owens and Minor BENZALKONIUM CHLORIDE .13 mg/100mg 39892-0601_931fe295-4949-43af-8c8d-f5a9d0239222 39892-0601 HUMAN OTC DRUG MEDICHOICE ANTICAVITY FLUORIDE SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20100518 OTC MONOGRAPH FINAL part355 Owens and Minor SODIUM FLUORIDE 22 g/100g 39892-0602_2a3293c5-95af-4b88-a4d0-cf0a7757825a 39892-0602 HUMAN OTC DRUG MediChoice Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20130301 OTC MONOGRAPH FINAL part355 Owens & Minor SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 39892-0603_cba4c13a-511a-4e4b-b0ef-a7d212d4f29c 39892-0603 HUMAN OTC DRUG MediChoice Premium Anticavity Fluoride SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130301 OTC MONOGRAPH FINAL part355 Owens & Minor SODIUM FLUORIDE 2.43 mg/g 39892-0801_8c4de8ef-bb5f-4b40-808e-6580809700b8 39892-0801 HUMAN OTC DRUG MediChoice Alcohol Swabstick ISOPROPYL ALCOHOL SWAB TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part333A Owens & Minor, Inc ISOPROPYL ALCOHOL 70 g/100g 39892-0802_c42a570f-0d99-4464-945d-213e6db68567 39892-0802 HUMAN OTC DRUG MediChoice PVP Swabsticks POVIDONE-IODINE SWAB TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part333E Owens and Minor POVIDONE-IODINE 10 g/100g 39892-0803_2051b289-b07e-412d-92a6-2328545f30aa 39892-0803 HUMAN OTC DRUG MediChoice Alcohol Swabstick ISOPROPYL ALCOHOL SWAB TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part333A Owens & Minor, Inc ISOPROPYL ALCOHOL 70 g/100g 39892-0804_c435faab-eeb7-4604-8e97-b82455c48429 39892-0804 HUMAN OTC DRUG MediChoice PVP Swabsticks POVIDONE-IODINE SWAB TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part333E Owens and Minor POVIDONE-IODINE 10 g/100g 39892-0900_ab7b37f4-4a77-49b9-89ab-26f35dfac061 39892-0900 HUMAN OTC DRUG MediChoice Lip Balm SPF 15 OXYBENZONE, OCTINOXATE LIPSTICK TOPICAL 20141222 OTC MONOGRAPH NOT FINAL part352 Owens & Minor Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 40002-002_331f6703-c665-4168-ae6b-4e38d58905f9 40002-002 HUMAN OTC DRUG Tolnaftate D Tolnaftate CREAM TOPICAL 20110815 OTC MONOGRAPH FINAL part333C NexMed (USA), Inc. TOLNAFTATE 1 g/100g 40002-003_5551bb51-cbd5-4ce2-94f5-15433eb899bc 40002-003 HUMAN OTC DRUG Hydrocortisone D Hydrocortisone CREAM TOPICAL 20110819 OTC MONOGRAPH NOT FINAL part348 NexMed (USA), Inc. HYDROCORTISONE 1 g/100g 40002-004_3846ecd5-9298-40e6-84d4-e1ef8815b86e 40002-004 HUMAN OTC DRUG Diphenhydramine D Diphenhydramine HCl, Zinc Acetate CREAM TOPICAL 20110829 OTC MONOGRAPH NOT FINAL part348 NexMed (USA), Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 40028-511_02c71354-8f3b-4d04-9696-2d6b3566101d 40028-511 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F 18 INJECTION, SOLUTION INTRAVENOUS 20080729 ANDA ANDA079086 PETNET Solutions, Inc. FLUDEOXYGLUCOSE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 40028-512_47514ce4-01ce-4bae-b5d3-15514b2bbac7 40028-512 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 Sodium Fluoride F 18 INJECTION, SOLUTION INTRAVENOUS 20110126 NDA NDA022494 PETNET Solutions, Inc. SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 40028-513_ad15cdd5-2e21-4c26-a428-977ee2cd4526 40028-513 HUMAN PRESCRIPTION DRUG Ammonia N 13 Ammonia N-13 INJECTION INTRAVENOUS 20070823 UNAPPROVED DRUG OTHER PETNET Solutions, Inc. AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 40032-030_ef387122-eb08-446d-a299-29c8179c54f1 40032-030 HUMAN PRESCRIPTION DRUG Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Monobasic Sodium Phosphate and Dibasic Sodium Phosphate TABLET ORAL 20120120 ANDA ANDA079247 Novel Laboratories, Inc. SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .398; 1.105 g/1; g/1 40032-050_0cb089b8-0127-4f5f-8b8d-77bc93409747 40032-050 HUMAN PRESCRIPTION DRUG Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate POWDER, FOR SOLUTION ORAL 20090528 ANDA ANDA090019 Novel Laboratories, Inc. POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420; 1.48; 5.72; 11.2 g/438.4g; g/438.4g; g/438.4g; g/438.4g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 40032-060_b76cfbc2-2ecf-478c-adae-a141ec93553d 40032-060 HUMAN PRESCRIPTION DRUG Polyethylene Glycol-3350 and Electrolytes with Flavor Pack Polyethylene Glycol-3350 and Electrolytes with Flavor Pack POWDER, FOR SOLUTION ORAL 20090601 ANDA ANDA090186 Novel Laboratories, Inc. POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 240; 2.98; 6.72; 5.84; 22.72 g/278.26g; g/278.26g; g/278.26g; g/278.26g; g/278.26g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 40032-090_d6e9f30d-5ff9-45bc-8a0d-3e7eacb560d7 40032-090 HUMAN PRESCRIPTION DRUG Polyethylene Glycol-3350 and Electrolytes Polyethylene Glycol-3350 and Electrolytes POWDER, FOR SOLUTION ORAL 20090601 ANDA ANDA090231 Novel Laboratories, Inc. POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 236; 2.97; 6.74; 5.86; 22.74 g/274.31g; g/274.31g; g/274.31g; g/274.31g; g/274.31g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 40032-118_f22ba8d7-779a-47b8-8bea-6865dc25438f 40032-118 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide TABLET ORAL 20140923 ANDA ANDA091528 Novel Laboratories, Inc. HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 40032-120_8bfc2252-e630-499c-9a04-d408bf9f9b7e 40032-120 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20120622 ANDA ANDA071457 Novel Laboratories, Inc. TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 40032-121_8bfc2252-e630-499c-9a04-d408bf9f9b7e 40032-121 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20091001 ANDA ANDA071456 Novel Laboratories, Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 40032-122_8bfc2252-e630-499c-9a04-d408bf9f9b7e 40032-122 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20120622 ANDA ANDA071457 Novel Laboratories, Inc. TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 40032-123_8bfc2252-e630-499c-9a04-d408bf9f9b7e 40032-123 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20091001 ANDA ANDA071457 Novel Laboratories, Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 40032-140_b7864f4a-89c2-4c87-b92c-7c46f0a9fd0a 40032-140 HUMAN PRESCRIPTION DRUG Methylergonovine Maleate Methylergonovine Maleate TABLET ORAL 20110615 ANDA ANDA091577 Novel Laboratories, Inc. METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 40032-160_9023f150-3ed0-445e-958a-1a82f6e90073 40032-160 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 Novel Laboratories, Inc. MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 40032-161_9023f150-3ed0-445e-958a-1a82f6e90073 40032-161 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 Novel Laboratories, Inc. MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 40032-312_6c926ac6-90c6-4752-af3a-ddd0963137a6 40032-312 HUMAN OTC DRUG Polyethylene Glycol-3350 Polyethylene Glycol-3350 POWDER, FOR SOLUTION ORAL 20091006 ANDA ANDA091077 Novel Laboratories, Inc. POLYETHYLENE GLYCOL 3350 17 g/17g 40032-330_782dcd5a-e015-49d9-8170-2506324132c5 40032-330 HUMAN PRESCRIPTION DRUG Trimethoprim trimethoprim TABLET ORAL 20110624 ANDA ANDA091437 Novel Laboratories,Inc. TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 40032-360_c3334c58-bba0-44a7-8d65-51ac865dd21d 40032-360 HUMAN PRESCRIPTION DRUG Phenelzine Sulfate Phenelzine Sulfate TABLET ORAL 20110214 ANDA ANDA200181 Novel Laboratories, Inc. PHENELZINE SULFATE 15 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] 40032-450_fd3c98a7-235d-446b-b878-c3a52c9d99f1 40032-450 HUMAN PRESCRIPTION DRUG Nitrofurantoin Oral Suspension Nitrofurantoin SUSPENSION ORAL 20140908 ANDA ANDA201693 Novel Laboratories, Inc. NITROFURANTOIN 25 mg/5mL Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 40032-500_d476f4fa-86f9-45f0-bfb0-64b3e34a6d83 40032-500 HUMAN PRESCRIPTION DRUG Famotidine Famotidine FOR SUSPENSION ORAL 20121217 ANDA ANDA201695 Novel Laboratories, Inc. FAMOTIDINE 40 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 40032-550_530af487-7e0b-4ad5-a45b-3f7d9b1b71ae 40032-550 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET ORAL 20120430 ANDA ANDA202044 Novel Laboratories, Inc. TINIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 40032-551_530af487-7e0b-4ad5-a45b-3f7d9b1b71ae 40032-551 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET ORAL 20120430 ANDA ANDA202044 Novel Laboratories, Inc. TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 40032-580_e386144b-3815-4770-8cb6-e7284219eb90 40032-580 HUMAN PRESCRIPTION DRUG METOCLOPRAMIDE hydrochloride Metoclopramide Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20140815 ANDA ANDA202191 Novel Laboratories, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 40032-581_e386144b-3815-4770-8cb6-e7284219eb90 40032-581 HUMAN PRESCRIPTION DRUG METOCLOPRAMIDE hydrochloride Metoclopramide Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20140815 ANDA ANDA202191 Novel Laboratories, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 40032-620_2d791cf6-fae5-4146-9cf0-e8a597ecd1bb 40032-620 HUMAN PRESCRIPTION DRUG Levonorgestrel Levonorgestrel TABLET ORAL 20130222 ANDA ANDA202508 Novel Laboratories, Inc. LEVONORGESTREL 1.5 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 40032-622_2bcc1f55-2731-4d9f-a03c-19a01eb98230 40032-622 HUMAN PRESCRIPTION DRUG Levonorgestrel Levonorgestrel TABLET ORAL 20130215 ANDA ANDA202508 Novel Laboratories, Inc. LEVONORGESTREL 1.5 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 40042-015_abeecced-ec75-467b-91bb-d8dc1d6de50b 40042-015 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC 20080116 ANDA ANDA078598 PharmaForce, Inc. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 40042-025_bc6037f0-dc1f-4535-81cb-d775565bd529 40042-025 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION, SOLUTION INTRAVENOUS 20100608 ANDA ANDA078867 PharmaForce, Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 40042-047_48a0e4e8-5520-4789-b508-deef6d0f3aa1 40042-047 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20091117 ANDA ANDA090534 PharmaForce, Inc. NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 40042-048_f8cfe50b-e269-47f2-8ce6-0b40511945bc 40042-048 HUMAN PRESCRIPTION DRUG Betamethasone Sodium Phosphate and Betamethasone Acetate Betamethasone Sodium Phosphate and Betamethasone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR 20090731 ANDA ANDA090747 PharmaForce, Inc. BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE 3; 3 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 40042-049_243c0b7c-8011-4a94-8b25-0329de936439 40042-049 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC) 20100121 ANDA ANDA090395 PharmaForce, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 40042-050_dc3647a7-842f-46ab-8b42-d19e66a251e9 40042-050 HUMAN PRESCRIPTION DRUG Progesterone Injection USP Progesterone Injection INJECTION, SOLUTION INTRAMUSCULAR 20090904 ANDA ANDA090845 PharmaForce, Inc. PROGESTERONE 50 mg/mL Progesterone [Chemical/Ingredient],Progesterone [EPC] 40042-052_f89df25e-bb64-4351-b3b4-c3eb34843648 40042-052 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride INJECTION, SOLUTION EPIDURAL 20091016 ANDA ANDA091104 PharmaForce, Inc. CLONIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 40042-053_f89df25e-bb64-4351-b3b4-c3eb34843648 40042-053 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride INJECTION, SOLUTION EPIDURAL 20091016 ANDA ANDA091104 PharmaForce, Inc. CLONIDINE HYDROCHLORIDE 500 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 40046-0030_55e576e5-b615-429a-90f5-f741d3d48209 40046-0030 HUMAN OTC DRUG TENDERTONE LIP BALM SPF 12 OCTINOXATE, OCTISALATE, and AVOBENZONE LIPSTICK TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 7.5; 2 mL/100mL; mL/100mL; mL/100mL 40046-0031_dd5fb00e-588e-4ebc-be2e-9a2444101961 40046-0031 HUMAN OTC DRUG MINERALIZE SPF 15 FOUNDATION LOOSE TITANIUM DIOXIDE POWDER TOPICAL 20070901 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS TITANIUM DIOXIDE 7 g/100g 40046-0032_5a09d299-9c80-4b6b-bdeb-4ffe9f290c77 40046-0032 HUMAN OTC DRUG STUDIO SCULPT SPF 15 FOUNDATION OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 MAKE UP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE 7; 2 mL/100mL; mL/100mL 40046-0033_b1fa5950-814e-4a88-9c8d-501afad0426e 40046-0033 HUMAN OTC DRUG STUDIO MOISTURE TINT SPF 15 OCTINOXATE GEL TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 MAKE UP ART COSMETICS OCTINOXATE 3.5 mL/100mL 40046-0034_1422a024-5cb7-4816-8c80-5981039d666d 40046-0034 HUMAN OTC DRUG SUNTINTS LIQUID LIP BALM SPF 20 OCTINOXATE, OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE LIPSTICK TOPICAL 20091201 OTC MONOGRAPH FINAL part352 MAKEUP ART COSMETICS AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 2.9; 7.5; 5; 2.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 40046-0036_e9ac9caf-34b9-4218-ae0a-fa2182c2898f 40046-0036 HUMAN OTC DRUG PREP (plus) PRIME BEAUTY BALM SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 MAKE-UP ART COSMETICS OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.4; 4; 2.5; 1.1; 3.5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 40046-0037_db752197-9555-43ce-adc3-7fb0b7194f2c 40046-0037 HUMAN OTC DRUG MINERALIZE FOUNDATION SPF 15 OCTINOXATE CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 MAKE-UP ART COSMETICS OCTINOXATE 10 g/100g 40046-0038_cd90398a-c66c-4466-999a-36aeaf8f659c 40046-0038 HUMAN OTC DRUG PRO-LONGWEAR SPF 10 FOUNDATION TITANIUM DIOXIDE LOTION TOPICAL 20100409 OTC MONOGRAPH NOT FINAL part352 MAKE UP ART COSMETICS TITANIUM DIOXIDE 4.7 mL/100mL 40046-0039_8e82c4a4-fbc9-46bb-980e-31e302be7f7a 40046-0039 HUMAN OTC DRUG PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE CREAM TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.4; 4; 2.5; 1.1; 3.5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 40046-0040_03403b18-7531-4a12-861c-95e588209f38 40046-0040 HUMAN OTC DRUG LIP CONDITIONER SPF 15 PLUS LAVENDER OCTINOXATE, OCTISALATE GEL TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE 7.5; 5 mL/100mL; mL/100mL 40046-0041_35751f57-240d-4e3e-b319-367fa63d7b78 40046-0041 HUMAN OTC DRUG TINTED LIP CONDITIONER SPF 15 PLUS LAVENDER OCTINOXATE, OCTISALATE GEL TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE 7.5; 5 mL/100mL; mL/100mL 40046-0042_a1fab374-4119-4c1a-8072-28717a6719ff 40046-0042 HUMAN OTC DRUG MINERALIZE SATIN FOUNDATION SPF 15 FOUNDATION OCTINOXATE LIQUID TOPICAL 20060901 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE 7.5 mL/100mL 40046-0043_91e3d67c-7165-4b28-9971-eea8e344c183 40046-0043 HUMAN OTC DRUG SMASHBOX CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 OCTINOXlATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 4; 2.5; 1.1 mL/100mL; mL/100mL; mL/100mL; mL/100mL 40046-0044_a033dc14-b42a-4f9f-b9f9-e00c1d8cb49d 40046-0044 HUMAN OTC DRUG SMASH BOX STUDIO SKIN 15 HOUR WEAR HYDRATING FOUNDATION SPF10 TITANIUM DIOXIDE LIQUID TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS TITANIUM DIOXIDE 4.7 mL/100mL 40046-0045_3382b9c9-82da-45fa-bffa-c2f2574bbf50 40046-0045 HUMAN OTC DRUG MATCHMASTER FOUNDATION SPF 15 OCTINOXATE, TITANIUM DIOXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE 3.4; 1 mL/100mL; mL/100mL 40046-0046_39b10a01-cdd9-4b41-857e-3f8ea313843a 40046-0046 HUMAN OTC DRUG STUDIO MOISTURE FIX SPF 15 ZINC OXIDE, OCTINOXATE LOTION TOPICAL 20060901 OTC MONOGRAPH NOT FINAL part352 MAKE UP ART COSMETICS OCTINOXATE; ZINC OXIDE 3.5; 6.7 mL/100mL; mL/100mL 40046-0047_6fbe638f-1a52-49ec-bede-ae636d329516 40046-0047 HUMAN OTC DRUG PREP and PRIME FACE PROTECTION SPF 50 ZINC OXIDE, OCTINOXATE CREAM TOPICAL 20060201 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; ZINC OXIDE 7.5; 16.1 mL/100mL; mL/100mL 40046-0048_c0ed0ee1-0b8a-4e11-aec8-dfc9d6b56ab4 40046-0048 HUMAN OTC DRUG STUDIO FINISH CONCEALER SPF 35 OCTINOXATE, TITANIUM DIOXIDE PASTE TOPICAL 20030901 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE 5; 2 g/100g; g/100g 40046-0049_f0d2beaa-423a-4249-9e76-fc10fb872ccb 40046-0049 HUMAN OTC DRUG TINTED LIP CONDITIONER SPF 15 OCTINOXATE, OCTISALATE GEL TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE 7.5; 5 mL/100mL; mL/100mL 40046-0050_9c8e9fd8-4461-4da6-9b00-5090973c5df9 40046-0050 HUMAN OTC DRUG STUDIO FIX FLUID SPF 15 OCTINOXATE, TITANIUM DIOXIDE LOTION TOPICAL 20051201 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE 2.5; 1 mL/100mL; mL/100mL 40046-0051_c259abd1-3cea-4574-bfb1-136b398f5fc1 40046-0051 HUMAN OTC DRUG TINTED LIP CONDITIONER SPF 15 OCTINOXATE, OCTISALATE GEL TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE 7.5; 5 mL/100mL; mL/100mL 40046-0052_abb755c2-8e3b-40d7-8e49-4d5061a09bc8 40046-0052 HUMAN OTC DRUG SELECT SPF 15 FOUNDATION OCTINOXATE CREAM TOPICAL 20011201 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE 7.5 mL/100mL 40046-0053_6615a397-12dd-44e8-ac96-f91bdd8b7e0f 40046-0053 HUMAN OTC DRUG LIP CONDITIONER SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE LIPSTICK TOPICAL 20050101 OTC MONOGRAPH NOT FINAL part352 MAKE UP ART COSMETICS OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 5; 1 g/100g; g/100g; g/100g 40046-0055_dfe7bfbf-48b3-45c5-a9ab-ba24812df845 40046-0055 HUMAN OTC DRUG MAC SELECT TINT SPF 15 OCTINOXATE LIQUID TOPICAL 20020801 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE 7.5 mL/100mL 40046-0056_c536f599-2180-45b3-a767-bf3923768d77 40046-0056 HUMAN OTC DRUG MAC HYPER REAL SPF 15 FOUNDATION OCTINOXATE LIQUID TOPICAL 20030601 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE 7 mL/100mL 40046-0057_6ac61092-2d20-45fd-a03b-e3be163388b1 40046-0057 HUMAN OTC DRUG STUDIO FOUNDATION SPF 15 OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20030806 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE 5; 2.9 g/100g; g/100g 40046-0061_d5052f50-2eb8-4113-9295-08b753512025 40046-0061 HUMAN OTC DRUG MINERALIZE MOISTURE SPF 15 FOUNDATION OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE 7.5; 2 mL/100mL; mL/100mL 40046-0062_c3c7b78b-aaf3-428b-9797-0abc3aa3781c 40046-0062 HUMAN OTC DRUG PREP PLUS PRIME BB BEAUTY BALM COMPACT BROAD SPECTRUM SPF 30 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 9.8; 6.3 g/100g; g/100g; g/100g; g/100g 40046-0064_3f1bc5ad-729f-4334-98b2-b44e160dfbe8 40046-0064 HUMAN OTC DRUG PREP (AND) PRIME BB BEAUTY BALM SPF 35 BROAD SPECTRUM SUNCREEN OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .08175; .0436; .02725; .01199 g/100mL; g/100mL; g/100mL; g/100mL 40046-0066_23e2d242-4e01-49d0-adca-6a1b2eb13e08 40046-0066 HUMAN OTC DRUG MATCHMASTER SPF 15 FOUNDATION BROAD SPECTRUM OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE .03723; .01095 g/100mL; g/100mL 40046-0068_7a5a7396-f72d-4e75-b7bd-8ce9b4ac718d 40046-0068 HUMAN OTC DRUG PREP AND PRIME BLEMISH CONTROL ACNE TREATMENT SALICYLIC ACID GEL TOPICAL 20130101 OTC MONOGRAPH FINAL part333D MAKEUP ART COSMETICS SALICYLIC ACID .008776 g/mL 40046-0069_4f2ff19c-83c0-4070-9897-248923241651 40046-0069 HUMAN OTC DRUG PREP (AND) PRIME CC COLOR CORRECT SPF30 BROAD SPECTRUM OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE .08175; .0436; .02725; .01199; .03597 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 40046-0070_cbd9b6e3-522b-4262-bd4b-ce0dbef87574 40046-0070 HUMAN OTC DRUG LIGHTFUL C SPF 30 WITH RADIANCE BOOSTER BROAD SPECTRUM SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .08175; .0436; .02725; .01199 g/100mL; g/100mL; g/100mL; g/100mL 40046-0071_c225b338-fc74-4541-bb6f-49b556a95680 40046-0071 HUMAN OTC DRUG MAC PRO LONGWEAR SPF 20 COMPACT FOUNDATION BROAD SPECTRUM SPF 20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE 2.4; 2.3 g/100g; g/100g 40046-0072_924799ff-ae2c-4c52-bb90-d881104a60cb 40046-0072 HUMAN OTC DRUG STUDIO FIX FLUID SPF 15 BROAD SPECTRUM OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20051201 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE .027375; .01095 g/100mL; g/100mL 40046-0073_1e27f8a9-48f8-4087-9022-f4dfbc09b3b3 40046-0073 HUMAN OTC DRUG STUDIO FIX FLUID BROAD SPECTRUM SPF 15 WITH ENRICHED ANTI-OXIDANT COMPLEX OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE .02775; .0111 g/100mL; g/100mL 40051-123_1526c0a0-5fa4-4cea-b332-4bcf0d048be8 40051-123 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120406 ANDA ANDA090906 Lotus Pharmaceutical Co., Ltd. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 40051-123_6a8f0533-5be3-4e56-b0b1-ef6a75153da2 40051-123 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120406 ANDA ANDA090906 Lotus Pharmaceutical Co., Ltd. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 40054-1003_a60618c6-2d05-41eb-b6fb-03fea49106ae 40054-1003 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20100101 UNAPPROVED MEDICAL GAS Northeast Home Medical Supplies Inc. OXYGEN 99 L/100L 40055-0614_6cafe16c-0be5-4e83-bbc6-77ce3e87f6c3 40055-0614 HUMAN OTC DRUG ANTIBACTERIAL WET WIPES TRAVEL PACK BENZALKONIUM CHLORIDE SWAB TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part333E Global Marketing Resources, Inc. BENZALKONIUM CHLORIDE .115 mL/100mL 40055-0938_0f72f474-e616-46e2-9d6d-a49bb9b8590f 40055-0938 HUMAN OTC DRUG ANTIBACTERIAL WET WIPES BENZALKONIUM CHLORIDE SWAB TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part333E Global Marketing Resources, Inc. BENZALKONIUM CHLORIDE .115 mL/100mL 40057-1000_43c0b759-3885-4dcc-8c8c-0a2d9bbc0211 40057-1000 HUMAN OTC DRUG Charm Tex Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20110601 OTC MONOGRAPH FINAL part355 Charm Tex, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 40057-1001_7375cd98-281b-4ece-bdc5-14ab02eaf788 40057-1001 HUMAN OTC DRUG Charm Tex Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110601 OTC MONOGRAPH FINAL part355 Charm Tex, Inc. SODIUM FLUORIDE .22 g/100g 40057-2000_053f2545-8f65-4817-badf-6edb97a7fd0d 40057-2000 HUMAN OTC DRUG Charm-Tex Deodorant Aluminum chlorohydrate STICK TOPICAL 20120117 OTC MONOGRAPH FINAL part350 Charm-Tex, Inc. ALUMINUM CHLOROHYDRATE 7.8 g/100g 40057-2001_7ded3795-c298-43ac-8f15-7c02e9c8a167 40057-2001 HUMAN OTC DRUG Charm-Tex ANTIPERSPIRANT ROLL-ON DEODORANT Aluminum chlorohydrate GEL TOPICAL 20120117 OTC MONOGRAPH FINAL part350 Charm-Tex, Inc ALUMINUM CHLOROHYDRATE 7.8 mL/100mL 40057-3000_76233513-b690-44a9-89fc-7b2744bb6a18 40057-3000 HUMAN OTC DRUG Antibacterial Bar Triclosan SOAP TOPICAL 20120229 OTC MONOGRAPH NOT FINAL part333E Charm-Tex, Inc TRICLOSAN .3 g/100g 40057-4000_6ff42ad7-e1b1-4d22-978b-ccc10d4431fa 40057-4000 HUMAN OTC DRUG Charm-Tex Deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20120117 OTC MONOGRAPH FINAL part350 Charm-Tex, Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 7.8 g/100g 40057-6001_c33f1c1c-c302-4576-a2ca-804d46afbe97 40057-6001 HUMAN OTC DRUG Charm-Tex ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY GEL TOPICAL 20120117 OTC MONOGRAPH FINAL part350 Charm-Tex, Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .3 mL/100mL 40061-990_3ab4001b-7023-42f0-bb32-f5d48a3603d9 40061-990 HUMAN OTC DRUG Patricks Sunscreen Avobenzone, Octinoxate, Octocrylene, Oxybenzone LOTION TOPICAL 20110428 OTC MONOGRAPH FINAL part352 O.P. Products, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 2; 7.25; 9.75; 3 g/100g; g/100g; g/100g; g/100g 40076-002_f85fd6b6-3911-4450-9d2a-5c515e036614 40076-002 HUMAN PRESCRIPTION DRUG VUSION miconazole nitrate, zinc oxide, white petrolatum OINTMENT TOPICAL 20070514 NDA NDA021026 Prestium Pharma, Inc. MICONAZOLE NITRATE; PETROLATUM; ZINC OXIDE 2.5; 813.5; 150 mg/g; mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 40076-021_d1529ecd-dcb2-460b-9683-6013226a09e9 40076-021 HUMAN PRESCRIPTION DRUG Luxiq Betamethasone Valerate AEROSOL, FOAM TOPICAL 20091016 NDA NDA020934 Prestium Pharma, Inc. BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 40076-031_75c833ed-6d36-4afe-9e6d-901a20c83bba 40076-031 HUMAN PRESCRIPTION DRUG OLUX clobetasol propionate AEROSOL, FOAM TOPICAL 20140207 NDA NDA021142 Prestium Pharma, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 40076-051_5859d21a-3353-42d9-a68e-3a5c92ad053f 40076-051 HUMAN PRESCRIPTION DRUG EXTINA ketoconazole AEROSOL, FOAM TOPICAL 20140110 NDA NDA021738 Prestium Pharma, Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 40076-061_91b5b266-63e2-4afb-a093-0142485018b8 40076-061 HUMAN PRESCRIPTION DRUG EVOCLIN clindamycin phosphate AEROSOL, FOAM TOPICAL 20140819 NDA NDA050801 Prestium Pharma, Inc. CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 40076-101_2127c5d2-7a37-4d40-b680-d121f0040171 40076-101 HUMAN PRESCRIPTION DRUG OLUX-E clobetasol propionate AEROSOL, FOAM TOPICAL 20070212 20150228 NDA NDA022013 Prestium Pharma, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 40076-115_4de55a80-67d6-42c0-a6fc-57b89400c5b3 40076-115 HUMAN PRESCRIPTION DRUG elimite Permethrin CREAM TOPICAL 20121024 ANDA ANDA076369 Prestium Pharma, Inc. PERMETHRIN 50 mg/100g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] 40076-315_dd35ad79-e738-44b8-857e-c6d7d1dedcc0 40076-315 HUMAN PRESCRIPTION DRUG ERYGEL erythromycin GEL TOPICAL 20140127 ANDA ANDA063211 Prestium Pharma, Inc. ERYTHROMYCIN 20 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 40076-318_fcd12354-0dbb-5992-bb42-b1f2416e6541 40076-318 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride SUPPOSITORY RECTAL 20140801 ANDA ANDA040428 Prestium Pharma, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 40076-319_fcd12354-0dbb-5992-bb42-b1f2416e6541 40076-319 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride SUPPOSITORY RECTAL 20140801 ANDA ANDA040428 Prestium Pharma, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 40076-320_d92c1bdc-592d-9025-ae72-cd0176606286 40076-320 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride SUPPOSITORY RECTAL 20140801 ANDA ANDA087165 Prestium Pharma, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 40076-624_6b634e97-a6f8-4e46-9e73-88234d7fcc9f 40076-624 HUMAN PRESCRIPTION DRUG Denavir penciclovir CREAM TOPICAL 20121023 NDA NDA020629 Prestium Pharma, Inc. PENCICLOVIR 10 mg/g DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 40076-945_cd7fb36b-986c-4360-8317-932904d90e03 40076-945 HUMAN PRESCRIPTION DRUG ZOVIRAX acyclovir TABLET ORAL 20140207 NDA NDA020089 Prestium Pharma, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 40076-949_cd7fb36b-986c-4360-8317-932904d90e03 40076-949 HUMAN PRESCRIPTION DRUG ZOVIRAX acyclovir TABLET ORAL 20140207 NDA NDA020089 Prestium Pharma, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 40076-953_cd7fb36b-986c-4360-8317-932904d90e03 40076-953 HUMAN PRESCRIPTION DRUG ZOVIRAX acyclovir SUSPENSION ORAL 20140207 NDA NDA019909 Prestium Pharma, Inc. ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 40076-991_cd7fb36b-986c-4360-8317-932904d90e03 40076-991 HUMAN PRESCRIPTION DRUG ZOVIRAX acyclovir CAPSULE ORAL 20140207 NDA NDA018828 Prestium Pharma, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 40085-215_dc021770-ca43-4f33-93b7-b5814c1f207e 40085-215 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20130627 ANDA ANDA076369 Renaissance Pharma, Inc. PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] 40085-218_5a8177c3-12e2-9e7b-dfe6-3b2a88d530dc 40085-218 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20140801 ANDA ANDA040428 Renaissance Pharma, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 40085-219_5a8177c3-12e2-9e7b-dfe6-3b2a88d530dc 40085-219 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20140801 ANDA ANDA040428 Renaissance Pharma, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 40085-220_9ad276ca-44ae-acfc-1046-3a501fd24d7d 40085-220 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20140801 ANDA ANDA087165 Renaissance Pharma, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 40085-842_41560e49-cf61-4e0e-9e42-f6fee06fabe9 40085-842 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir SUSPENSION ORAL 20140903 NDA AUTHORIZED GENERIC NDA019909 Renaissance Pharma, Inc. ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 40085-888_fa85d1c4-0052-496d-b5ec-d693b79b1306 40085-888 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate AEROSOL, FOAM TOPICAL 20140206 NDA AUTHORIZED GENERIC NDA021142 Renaissance Pharma, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 40085-893_70d14e78-f1ef-4485-9678-112ff9de02f0 40085-893 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Emulsion clobetasol propionate AEROSOL, FOAM TOPICAL 20140206 NDA AUTHORIZED GENERIC NDA022013 Renaissance Pharma, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 40089-113_35cc3f2c-796a-4b38-8c25-7f1b802ddddc 40089-113 HUMAN PRESCRIPTION DRUG Ammonia N 13 NH3N13 INJECTION INTRAVENOUS 20120321 ANDA ANDA204514 The Johns Hopkins University AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 40092-500_858180c1-595c-4e25-99e8-ad5a97b0523c 40092-500 HUMAN OTC DRUG GOLDSHIELD 24 GS 24 BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20141121 OTC MONOGRAPH NOT FINAL part333A AP GOLDSHIELD LLC BENZALKONIUM CHLORIDE .001 g/g 40092-600_97d5938f-b627-4a86-bf0b-4ac50b708725 40092-600 HUMAN OTC DRUG VETERAN SHIELD 24 VSH BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20120615 OTC MONOGRAPH NOT FINAL part333A AP GOLDSHIELD LLC BENZALKONIUM CHLORIDE .001 g/g 40096-0076_0f83381f-d53c-46a8-a106-174de48aaa0f 40096-0076 HUMAN OTC DRUG TOUGH GUY INSTANT HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333E W.W. Grainger, Inc. ALCOHOL 62 mL/100mL 40096-0802_0cf2ec12-156b-4a45-842d-85f0d44ed434 40096-0802 HUMAN OTC DRUG Tough Guy Hand Sanitizer Wipes Tough Guy Hand Sanitizer Wipes CLOTH TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part333 W.W. Grainger, Inc. BENZALKONIUM CHLORIDE; BENZETHONIUM CHLORIDE .1; .1 g/970mL; g/970mL 40098-101_229d2758-2d70-437e-bcfa-1863bef581d8 40098-101 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F-18 Fludeoxyglucose F-18 INJECTION, SOLUTION INTRAVENOUS 20141029 ANDA ANDA203801 Trustees of the University of Pennsylvania FLUDEOXYGLUCOSE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 40104-001_4c45fa9f-5501-4ebf-aa2e-b8ea3dcafd13 40104-001 HUMAN OTC DRUG meijer kids BENZALKONIUM CHLORIDE LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co.,Ltd. BENZALKONIUM CHLORIDE .596 g/298g 40104-002_8088ac42-2f8e-4457-ab24-433e3ef3c980 40104-002 HUMAN OTC DRUG meijer kids BENZALKONIUM CHLORIDE LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co.,Ltd. BENZALKONIUM CHLORIDE .596 g/298g 40104-003_2834a2c2-43af-4261-af1d-ffe0b1de949a 40104-003 HUMAN OTC DRUG meijer kids BENZALKONIUM CHLORIDE LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co.,Ltd. BENZALKONIUM CHLORIDE .596 g/298g 40104-139_d7453c11-5fa1-4037-90f3-5072378b24bf 40104-139 HUMAN OTC DRUG modesa antibacterial hand sanitizer lemon ALCOHOL GEL TOPICAL 20141216 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL 40104-201_647e7ba5-7348-480a-8ecf-bce8d67e3e96 40104-201 HUMAN OTC DRUG 2 Pack Assured Instant Hand Sanitizer with moisturizers (Vitamin E and aloe) lemon scented ALCOHOL GEL TOPICAL 20140510 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL 40104-261_2b7387cb-b004-4254-a00b-ee577a5078a6 40104-261 HUMAN OTC DRUG Faith Family Ducks Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140912 OTC MONOGRAPH NOT FINAL part333E Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL 40104-262_7b2425b4-fb13-4b3c-9eef-8011aba3719c 40104-262 HUMAN OTC DRUG Superman Berry Scented Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140912 OTC MONOGRAPH NOT FINAL part333E Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL 40104-263_08398e23-6e5b-4f0b-a8df-623f3c55fb42 40104-263 HUMAN OTC DRUG Batman Berry Scented Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140912 OTC MONOGRAPH NOT FINAL part333E Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL 40104-323_41a2f7ee-963b-4a84-b65f-8795140f3bd7 40104-323 HUMAN OTC DRUG 3 Pack Assured Instant Hand Sanitizer with moisturizers (Vitamin E and aloe) lemon scented ALCOHOL GEL TOPICAL 20141102 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL 40104-324_641a5b8b-b746-49d1-8912-bdb084f0ccfe 40104-324 HUMAN OTC DRUG 3 Pack Assured Instant Hand Sanitizer with moisturizers (Vitamin E and moisturizers) lavender scented ALCOHOL GEL TOPICAL 20141102 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL 40104-325_16554444-a342-48d0-8a2d-5f0abd5b9bd1 40104-325 HUMAN OTC DRUG 3 Pack Assured Instant Hand Sanitizer with moisturizers (aloe vera and moisturizers) ALCOHOL GEL TOPICAL 20141102 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL 40104-351_df5afbde-2045-40fc-a964-a9243fe13dc3 40104-351 HUMAN OTC DRUG Lalaloopsy Watermelon Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140902 OTC MONOGRAPH NOT FINAL part333E Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL 40104-352_67528bf0-33de-4ecf-bb76-bbe892d791b9 40104-352 HUMAN OTC DRUG Lisa Frank Bubblegum Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140902 OTC MONOGRAPH NOT FINAL part333E Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL 40104-353_0c6aa7fd-95d1-418f-8786-623bdcd96b93 40104-353 HUMAN OTC DRUG My Little Pony Grape Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140902 OTC MONOGRAPH NOT FINAL part333E Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL 40104-354_3fd43e84-9c84-49f1-9b78-4f0d8e90c283 40104-354 HUMAN OTC DRUG Care Bears Cotton Candy Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140902 OTC MONOGRAPH NOT FINAL part333E Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL 40104-355_2189112e-ecbf-40c3-a36c-b6a121979a7c 40104-355 HUMAN OTC DRUG Strawberry Shortcake Berry Best Friends Mixed Berry Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140902 OTC MONOGRAPH NOT FINAL part333E Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL 40104-360_be970ecb-b337-4da7-aff9-9b87483321c5 40104-360 HUMAN OTC DRUG 3 Pack Family Dollar instant Hand Sanitizers Alcohol KIT 20141128 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. 40104-520_7bc30483-f769-4cc9-83cf-f30a3c8ab0c3 40104-520 HUMAN OTC DRUG Family Dollar Instant Hand Sanitizer with Moisturizers and Vitamin E Alcohol GEL TOPICAL 20141020 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 65 mL/100mL 40104-556_9f62a572-23d1-409d-859e-711ee23e7aef 40104-556 HUMAN OTC DRUG Virx Instant Hand Sanitizing Spray with Aloe Vera SPRAY TOPICAL 20090930 OTC MONOGRAPH FINAL part333 Ningbo Pulisi Daily Chemical Products Co., Ltd TRICLOSAN 1.2 mL/10mL 40104-703_50116fe2-1df8-4744-a712-188025007da1 40104-703 HUMAN OTC DRUG Virx Instant Hand Sanitizer GEL TOPICAL 20100201 OTC MONOGRAPH FINAL part333 Ningbo Pulisi Daily Chemical Products Co., Ltd ALCOHOL 618.1 mL/947mL 40104-811_96fb17ee-eb73-4082-b423-7736820e1906 40104-811 HUMAN OTC DRUG Virx Hand Sanitizer and Moisturizer with Shea Butter LOTION TOPICAL 20090930 OTC MONOGRAPH FINAL part333 Ningbo Pulisi Daily Chemical Products ALCOHOL 154 mL/236mL 40171-003_d0de35eb-7330-475d-9bc9-d85f63811d73 40171-003 HUMAN OTC DRUG blink tears polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20080317 OTC MONOGRAPH FINAL part349 AMO Manufacturing Spain SL POLYETHYLENE GLYCOL 400 2.5 mg/mL 41163-001_fa723e26-526d-4efd-b12d-2e9a11b9dc09 41163-001 HUMAN OTC DRUG equaline heartburn prevention Famotidine TABLET ORAL 20141205 ANDA ANDA077351 Supervalu Inc FAMOTIDINE 20 mg/1 41163-002_cdd3a5a3-cbe3-4a70-af8d-74e41c026d54 41163-002 HUMAN OTC DRUG equaline enema Saline ENEMA RECTAL 20091106 OTC MONOGRAPH NOT FINAL part334 Supervalu Inc SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 41163-003_28fbf855-39a3-4259-aa81-5ce008e009c9 41163-003 HUMAN OTC DRUG Body Menthol POWDER TOPICAL 20130927 OTC MONOGRAPH NOT FINAL part348 Supervalu MENTHOL 1.5 mg/g 41163-005_671da901-27bb-481c-88bf-e69518457f2f 41163-005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 Supervalu Inc SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 41163-006_ffae856e-3ac5-4dc5-802c-7a86c9baa6a8 41163-006 HUMAN OTC DRUG Stool Softener easy and gentle DOCUSATE SODIUM CAPSULE ORAL 20130404 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) DOCUSATE SODIUM 100 mg/1 41163-008_1ee283f3-3e71-4688-b13f-183a9cc75119 41163-008 HUMAN OTC DRUG Equaline pain relief infants concentrated Acetaminophen SUSPENSION/ DROPS ORAL 20040924 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 80 mg/.8mL 41163-010_8fc11c4d-e1b8-4606-b4d8-e0542685c22e 41163-010 HUMAN OTC DRUG Non Drowsy Cold and Cough PE Acetaminophen, Dextromathorphan HBr, Gauifenesin, Phenylephrine HCl CAPSULE, COATED ORAL 20070222 OTC MONOGRAPH FINAL part341 SUPERVALU INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 41163-013_39df50ec-b7d3-4f07-9675-52ad19ccef8c 41163-013 HUMAN OTC DRUG equaline allergy and congestion relief Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20130213 ANDA ANDA076050 Supervalu Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 41163-014_a007c7cb-e2c2-4b1b-bebc-769ffff0dbbc 41163-014 HUMAN OTC DRUG Equaline nighttime cold multi symptom Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070919 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 41163-016_f8f88d9d-723a-4c5f-8000-b81745e994f5 41163-016 HUMAN OTC DRUG equaline triple antibiotic bacitracin zinc, neomycin sulfate, and polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Supervalu Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 41163-017_22345f2a-8718-41ce-a7c3-40d47790c652 41163-017 HUMAN OTC DRUG First Aid Antiseptic POVIDONE-IODINE SOLUTION TOPICAL 20120308 OTC MONOGRAPH NOT FINAL part333E Supervalu Inc POVIDONE-IODINE 10 mg/mL 41163-019_98ec21bd-a883-4441-9a5a-c0f79f23a931 41163-019 HUMAN OTC DRUG allergy relief diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 SUPERVALU INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41163-020_1f72fd7e-9b6b-4180-a508-d5005e0f20d5 41163-020 HUMAN OTC DRUG Diaper Rash Zinc oxide PASTE TOPICAL 20091118 OTC MONOGRAPH FINAL part347 Supervlau, Inc ZINC OXIDE 532 mg/g 41163-022_26bb576e-19c9-4103-b7bd-3bc0cf286eaa 41163-022 HUMAN OTC DRUG equaline acid reducer Cimetidine TABLET ORAL 20040915 ANDA ANDA075285 Supervalu Inc CIMETIDINE 200 mg/1 41163-029_f73e8b37-b2bf-415c-b9e2-c8d481ab459c 41163-029 HUMAN OTC DRUG equaline nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20080917 ANDA ANDA076775 Supervalu Inc NICOTINE 2 mg/1 41163-036_82ef9fb5-fb9b-4b9e-9f80-b081e3bf7a44 41163-036 HUMAN OTC DRUG Mucus Relief Cold Flu Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20140530 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL 41163-037_9c134a0f-48f1-4240-bac1-9b7188d7d508 41163-037 HUMAN OTC DRUG Mucus Relief Severe Congestion Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20140530 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL 41163-047_9e125b94-e3cc-4f33-8e7c-ae8921f65498 41163-047 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141130 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL 41163-049_c4b826b8-4079-4e08-b9eb-6c5306abb339 41163-049 HUMAN OTC DRUG Equaline muscle rub ultra strength Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20081204 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g 41163-050_22f0f4fe-a93c-4815-8d4c-2eefaecce456 41163-050 HUMAN OTC DRUG equaline ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090302 ANDA ANDA079113 Supervalu Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 41163-052_1eee11ca-a817-4ecb-bbd9-cb34a8c47a85 41163-052 HUMAN OTC DRUG Povidone Iodine povidone-iodine SOLUTION TOPICAL 20041001 OTC MONOGRAPH NOT FINAL part333A Supervalu Inc POVIDONE-IODINE .1 mg/mL 41163-054_7a7fa9d8-c09b-4ef4-83e6-12c15b30c792 41163-054 HUMAN OTC DRUG Equaline 12 Hour Decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20040810 ANDA ANDA075153 Supervalu Inc PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 41163-056_ddb8e717-69e2-4bb8-bd36-6ca1d619b0a1 41163-056 HUMAN OTC DRUG Equaline Nighttime Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140216 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 41163-057_c611afc0-5cde-4f01-908a-de52cb61ab02 41163-057 HUMAN OTC DRUG Equaline Ibuprofen ibuprofen SUSPENSION ORAL 20040907 ANDA ANDA075217 Supervalu Inc IBUPROFEN 50 mg/1.25mL 41163-061_20531c77-facf-42c8-8b50-639211bb2a36 41163-061 HUMAN OTC DRUG equaline nasal oxymetazoline hydrochloride SPRAY NASAL 20140715 OTC MONOGRAPH FINAL part341 Supervalu Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 41163-062_a26b8b64-1134-44b2-a160-2c89eb2a03dc 41163-062 HUMAN OTC DRUG Maximum Strength Heartburn Relief Ranitidine TABLET ORAL 20130615 ANDA ANDA200536 SUPERVALU INC. RANITIDINE HYDROCHLORIDE 150 mg/1 41163-067_58ff1e78-5690-48ac-93ee-774604bbf73d 41163-067 HUMAN OTC DRUG equaline triple antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20140328 OTC MONOGRAPH FINAL part333B Supervalu Inc BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 41163-069_9d0c306d-ca6f-42d6-b244-cae09b369cd6 41163-069 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20090105 OTC MONOGRAPH FINAL part347 Supervalu, Inc PETROLATUM 1 g/g 41163-073_d0ccc855-bc4a-474c-8256-7170e022d022 41163-073 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20050620 OTC MONOGRAPH NOT FINAL part333A Supervalu Inc ISOPROPYL ALCOHOL 500 mg/mL 41163-074_94e82683-b20c-462e-9005-a85f30cdc1f8 41163-074 HUMAN OTC DRUG Equaline ibuprofen Ibuprofen TABLET, COATED ORAL 20060307 ANDA ANDA077349 Supervalu Inc IBUPROFEN 200 mg/1 41163-075_4e483312-3e61-4fde-aa2e-d52807218d26 41163-075 HUMAN OTC DRUG equaline Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Supervalu Inc BACITRACIN ZINC 500 [iU]/g 41163-076_71e41056-f98c-4dec-8ad2-2223a1fa6894 41163-076 HUMAN OTC DRUG equaline antibiotic plus pain relief for kids Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Supervalu Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g 41163-078_252d318d-0aa5-4241-be6e-f19473519bdb 41163-078 HUMAN OTC DRUG Castor Oil Castor Oil LIQUID ORAL 20041216 OTC MONOGRAPH NOT FINAL part334 Supervalu, Inc CASTOR OIL 1 g/mL 41163-080_fa8f580f-c408-4dab-ab56-9d598e31d709 41163-080 HUMAN OTC DRUG athletes foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Supervalu Inc TERBINAFINE HYDROCHLORIDE 1 g/100g 41163-083_552080f7-3a34-4a45-80be-8477317b27a1 41163-083 HUMAN OTC DRUG equaline ibuprofen cold and sinus Ibuprofen, Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20040921 ANDA ANDA074567 Supervalu Inc IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 41163-089_30df2420-ff69-44b5-9fb2-7bdc52a64477 41163-089 HUMAN OTC DRUG equaline anti-itch Diphenhydramine hydrochloride and Zinc acetate CREAM TOPICAL 20050920 OTC MONOGRAPH FINAL part348 Supervalu Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g 41163-090_bfd1d210-1838-4044-8515-3c67088ed2f5 41163-090 HUMAN OTC DRUG equaline daytime nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110726 OTC MONOGRAPH FINAL part341 Supervalu Inc 41163-090_ea4b9b64-e56a-415c-bd1a-0294cc29cc7c 41163-090 HUMAN OTC DRUG equaline cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110726 OTC MONOGRAPH FINAL part341 Supervalu Inc 41163-092_d0ef093b-92fd-48bf-9d34-5ca52b483d44 41163-092 HUMAN OTC DRUG equaline Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Supervalu Inc LORATADINE 5 mg/5mL 41163-094_039f0607-13a9-40b7-8707-b5a8644432c1 41163-094 HUMAN OTC DRUG equaline nasal decongestant pe non drowsy maximum strength Phenylephrine Hydrochloride TABLET ORAL 20050207 OTC MONOGRAPH FINAL part341 Supervalu Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 41163-098_8145dbc9-723d-4a96-912c-45b1a9ff7d4d 41163-098 HUMAN OTC DRUG Tussin Cough Long Acting DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20090513 OTC MONOGRAPH FINAL part341 Equaline DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL 41163-099_be081cd1-8776-4696-9b47-32787be3c3f6 41163-099 HUMAN OTC DRUG Clear Anti Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 20050402 OTC MONOGRAPH FINAL part347 Supervalu, Inc PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL 41163-104_d5683b32-c9f2-4f63-94e6-4eefb3017c42 41163-104 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 19900713 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN 325 mg/1 41163-105_7174686e-8ee9-442a-b87a-9a70f71e81bd 41163-105 HUMAN OTC DRUG equaline pain relief childrens Acetaminophen SUSPENSION ORAL 20040907 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-109_0a11ee3f-b4db-47b9-ba4a-a22f1533f202 41163-109 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100330 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) DOCUSATE SODIUM 100 mg/1 41163-110_e3011c94-ced0-481e-b1fd-01c4a49323f8 41163-110 HUMAN OTC DRUG equaline childrens pain and fever Acetaminophen SUSPENSION ORAL 20111031 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-111_baa19edb-d585-451e-a536-96293f2a7688 41163-111 HUMAN OTC DRUG Oral Saline Laxative dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20120716 OTC MONOGRAPH NOT FINAL part334 SuperValu, Inc. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 2.7; 7.2 g/15mL; g/15mL 41163-112_8fd3e567-7c0d-42f6-8c8f-ab48d8ed6510 41163-112 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET ORAL 19810825 OTC MONOGRAPH FINAL part341 SUPERVALU INC. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 41163-115_74b4be71-9aac-4e2e-acbb-71e7bae73e84 41163-115 HUMAN OTC DRUG womans laxative Bisacodyl TABLET ORAL 20130412 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) BISACODYL 5 mg/1 41163-117_5de92bd6-9b79-4e49-b622-10a6bafa701f 41163-117 HUMAN OTC DRUG equaline lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120521 ANDA ANDA202319 Supervalu Inc LANSOPRAZOLE 15 mg/1 41163-119_4b9f50f0-ee62-46ca-8c5e-fcbfea5913be 41163-119 HUMAN OTC DRUG Equaline Night Time Sleep Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140307 OTC MONOGRAPH FINAL part338 Supervalu Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41163-120_a8883382-d986-438b-8110-decf112f7316 41163-120 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100824 ANDA ANDA078682 SuperValu (Equaline) IBUPROFEN 200 mg/1 41163-121_3ab1de8e-98cb-46e9-b6a2-9ad20bf1a9a5 41163-121 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100708 ANDA ANDA078682 SuperValu (Equaline) IBUPROFEN 200 mg/1 41163-122_93bbffc3-54a3-4374-815e-e2b3d60b3291 41163-122 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100709 ANDA ANDA078682 SuperValu (Equaline) IBUPROFEN 200 mg/1 41163-124_a338dcc4-8f5f-4f58-beb4-33c0c5bb2f2a 41163-124 HUMAN OTC DRUG equaline nicotine Nicotine Polacrilex LOZENGE ORAL 20120221 ANDA ANDA090711 Supervalu Inc NICOTINE 2 mg/1 41163-127_ecb0ceca-dcb8-4bed-9cbd-8f78e25ffd39 41163-127 HUMAN OTC DRUG DiBromm with PE BROMPHENIRAMINE MALEATE,PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20090513 OTC MONOGRAPH FINAL part341 Equaline BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 41163-130_66a0ad64-530f-476b-a91a-2ec7df419647 41163-130 HUMAN OTC DRUG Childrens Plus Cough and Runny Nose ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, SUSPENSION ORAL 20090513 OTC MONOGRAPH FINAL part341 Equaline ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL 41163-133_cb78ac3f-3479-47b3-b766-7348766d8498 41163-133 HUMAN OTC DRUG equaline flu and sore throat acetaminophen,pheniramine maleate, phenylephrine hydrochloride POWDER, FOR SUSPENSION ORAL 20110803 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/15000mg; mg/15000mg; mg/15000mg 41163-139_21112d81-e38e-4f41-9ea1-430f2bd46436 41163-139 HUMAN OTC DRUG Laxative maximum strength Sennosides TABLET ORAL 20100823 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) SENNOSIDES 25 mg/1 41163-140_98b42185-5f22-4ec0-a82b-ef9af2665348 41163-140 HUMAN OTC DRUG equaline all day pain relief Naproxen sodium TABLET, FILM COATED ORAL 20050208 ANDA ANDA074661 Supervalu Inc NAPROXEN SODIUM 220 mg/1 41163-141_bc6cb63d-f38f-448f-a159-acc3153ab099 41163-141 HUMAN OTC DRUG Childrens Acetaminophen Oral Suspension Grape Flavor Acetaminophen LIQUID ORAL 20090729 OTC MONOGRAPH FINAL part341 Equaline ACETAMINOPHEN 500 mg/5mL 41163-142_0286fcff-4172-4fb5-ba5d-139fc8efcf37 41163-142 HUMAN OTC DRUG equaline vagicaine maximum strength Benzocaine, Resorcinol CREAM TOPICAL 20050520 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc BENZOCAINE; RESORCINOL 20; 3 g/100g; g/100g 41163-146_45ab48b0-6710-49d8-9531-44b8d7e093ae 41163-146 HUMAN OTC DRUG equaline stomach relief Bismuth subsalicylate LIQUID ORAL 20041014 OTC MONOGRAPH FINAL part335 Supervalu Inc BISMUTH SUBSALICYLATE 262 mg/15mL 41163-154_8ee0bcad-70ee-40ad-a959-858d932cc813 41163-154 HUMAN OTC DRUG equaline athletes foot tolnaftate SPRAY TOPICAL 20040911 OTC MONOGRAPH FINAL part333C Supervalu Inc TOLNAFTATE 1 g/100g 41163-156_4d55620f-cb6c-4884-9a49-17e99674a33a 41163-156 HUMAN OTC DRUG Cough Relief Orange DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20090513 OTC MONOGRAPH FINAL part341 Equaline DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 41163-157_efe31f7c-c8fe-4e49-baee-05e29682e13d 41163-157 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20060210 OTC MONOGRAPH FINAL part343 SUPERVALU INC. ASPIRIN 325 mg/1 41163-159_e2d86ec6-1df2-45b1-9b47-0a44f5a23d40 41163-159 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin, Caffeine TABLET ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 41163-160_45d835b1-fb35-475a-909c-682d29ea3575 41163-160 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20130315 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 41163-161_94f643a4-1154-4331-be13-8faef622a30e 41163-161 HUMAN OTC DRUG equaline infants pain and fever Acetaminophen LIQUID ORAL 20120705 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-163_6f491cd1-adab-4958-ad60-126589422064 41163-163 HUMAN OTC DRUG EQUALINE TRICLOSAN LIQUID TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part333E SUPERVALU INC. TRICLOSAN .46 mg/100mL 41163-163_db1dcc82-960e-4390-b951-bd0a3b81b550 41163-163 HUMAN OTC DRUG EQUALINE TRICLOSAN LIQUID TOPICAL 20120626 OTC MONOGRAPH NOT FINAL part333E SUPERVALU INC. TRICLOSAN .46 mg/100mL 41163-165_4718aacc-826e-4ea6-aa4f-affad8b62a75 41163-165 HUMAN OTC DRUG Loratadine and Pseudoephedrine Loratadine and Pseudoephedrine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 SUPERVALU INC. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 41163-166_ad711385-2c24-4bce-8404-1061f5681535 41163-166 HUMAN OTC DRUG Equaline ibuprofen childrens Ibuprofen SUSPENSION ORAL 20041007 ANDA ANDA074937 Supervalu Inc IBUPROFEN 100 mg/5mL 41163-167_90265a1c-e61a-4503-8513-72604acdcfb7 41163-167 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20130509 ANDA ANDA079096 EQUALINE (SuperValu) NAPROXEN SODIUM 220 mg/1 41163-168_47615278-e8d5-48f7-a6fd-7f325101b198 41163-168 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111024 OTC MONOGRAPH NOT FINAL part333E SUPERVALU INC TRICLOSAN .6 mL/100mL 41163-169_aa033b1d-509c-44a1-ad49-967c6c241d3e 41163-169 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20101115 ANDA ANDA079096 SuperValu (Equaline) NAPROXEN SODIUM 220 mg/1 41163-170_9e32dfe8-0c1e-411c-a33c-1baf6a4a8789 41163-170 HUMAN OTC DRUG equaline nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20080908 ANDA ANDA076789 Supervalu Inc NICOTINE 4 mg/1 41163-173_7903c509-42a8-48f0-99a1-b597f4f0eba3 41163-173 HUMAN OTC DRUG equaline lice solution Piperonyl Butoxide, Pyrethrum Extract KIT 20070929 OTC MONOGRAPH FINAL part358G Supervalu Inc 41163-174_4af930f4-a1c5-4bf1-81ff-f8191b3027e0 41163-174 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20140930 NDA NDA021920 EQUALINE (SuperValu) NAPROXEN SODIUM 220 mg/1 41163-175_7cb3653a-048d-44f3-9b67-f449576ab360 41163-175 HUMAN OTC DRUG equaline pain relief childrens Acetaminophen SUSPENSION ORAL 20040907 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-176_ecb2be3a-8c35-44b7-9c16-347b785071f6 41163-176 HUMAN OTC DRUG Equaline All Day Allergy D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080730 ANDA ANDA077170 Supervalu Inc CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 41163-177_4574b0e9-f8a3-44fc-b0a9-6d6d7344a674 41163-177 HUMAN OTC DRUG EQUALINE TRICLOSAN LIQUID TOPICAL 20120626 OTC MONOGRAPH NOT FINAL part333E SUPERVALU INC. TRICLOSAN .46 mg/100mL 41163-179_e35daffe-a98f-472d-a108-64822958712e 41163-179 HUMAN OTC DRUG equaline antacid Calcium carbonate TABLET, CHEWABLE ORAL 20041028 OTC MONOGRAPH FINAL part331 Supervalu Inc CALCIUM CARBONATE 750 mg/1 41163-180_8e0e3907-329f-4421-802d-61a5ac2a25bd 41163-180 HUMAN OTC DRUG Night Time Original Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090317 OTC MONOGRAPH FINAL part341 Equaline ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 41163-180_f0ce8526-b2f9-4662-93a2-ba8eb69f1d9c 41163-180 HUMAN OTC DRUG Night Time Original Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20051108 OTC MONOGRAPH FINAL part341 Equaline ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 41163-181_125b1621-0807-404f-acd2-44cb1eff4f4b 41163-181 HUMAN OTC DRUG Senna laxative Natural vegetable laxative SENNOSIDES TABLET ORAL 20100707 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) SENNOSIDES 8.6 mg/1 41163-182_05433f2c-9291-42dd-bd65-c3241b93b3bb 41163-182 HUMAN OTC DRUG Night Time Cherry Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090317 OTC MONOGRAPH FINAL part341 Equaline ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 41163-186_fc7c62ca-7652-4cce-96ed-d79745aaaa0c 41163-186 HUMAN OTC DRUG Equaline Night Time Sleep Aid Diphenhydramine HCl SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part338 Supervalu Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 41163-188_2df0bad8-8c68-491d-853a-d296ffef342f 41163-188 HUMAN OTC DRUG Equaline Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140110 OTC MONOGRAPH FINAL part346 Supervalu Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 41163-190_4b283d2d-3cad-4b87-b54b-f87348c83bbc 41163-190 HUMAN OTC DRUG equaline nicotine Nicotine Polacrilex LOZENGE ORAL 20120303 ANDA ANDA090711 Supervalu Inc NICOTINE 4 mg/1 41163-194_f4c6169a-7919-4b26-b315-9ad9fb806d69 41163-194 HUMAN OTC DRUG Allergy Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 SUPERVALU INC. CHLORPHENIRAMINE MALEATE 4 mg/1 41163-195_8657f854-79eb-4855-8750-94ad3396dfb2 41163-195 HUMAN OTC DRUG Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20130331 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) BISACODYL 5 mg/1 41163-198_23703e90-47c9-475d-b820-fdc6057760ad 41163-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120110 ANDA ANDA078682 EQUALINE (SuperValu) IBUPROFEN 200 mg/1 41163-199_eddc8181-cd38-453c-9bde-cd4359f02dfb 41163-199 HUMAN OTC DRUG equaline miconazole 1 Miconazole nitrate KIT 20100611 ANDA ANDA079114 Supervalu Inc 41163-201_e091411c-4ea9-4c6e-88cf-ad678abb8c22 41163-201 HUMAN OTC DRUG Day Time with PE Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20090320 OTC MONOGRAPH FINAL part341 Supervalu ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 41163-202_8866398a-f8d7-4ed0-854c-38381acff3f9 41163-202 HUMAN OTC DRUG Equaline Hair Regrowth Treatment For Women minoxidil SOLUTION TOPICAL 20110417 ANDA ANDA075357 Supervalu Inc MINOXIDIL 2 g/100mL 41163-205_07e9cbeb-2645-4ad0-932c-cb180ae6b9e7 41163-205 HUMAN OTC DRUG equaline athletes foot Tolnaftate SPRAY TOPICAL 20040911 OTC MONOGRAPH FINAL part333C Supervalu Inc TOLNAFTATE 1 g/100g 41163-206_2132de8a-5274-438d-b113-478786ce9683 41163-206 HUMAN OTC DRUG equaline nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20080918 ANDA ANDA078325 Supervalu Inc NICOTINE 2 mg/1 41163-209_022e009e-0192-4089-86f3-4d63448e0f88 41163-209 HUMAN OTC DRUG equaline first aid antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20141124 OTC MONOGRAPH FINAL part333B Supervalu Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP&apos'U]/g; mg/g; [USP&apos'U]/g 41163-211_36f3b9ea-f9ef-4900-b02b-532e54da4fe0 41163-211 HUMAN OTC DRUG equaline infants acetaminophen Acetaminophen SUSPENSION ORAL 20141229 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-213_bb2f4e5d-6f3c-4b06-a191-9ab0b332844a 41163-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20090514 OTC MONOGRAPH FINAL part355 Supervalu, Inc SODIUM FLUORIDE .05 kg/100L 41163-214_dc645f2b-1c15-4134-8f4e-100d8441ac8c 41163-214 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20130325 OTC MONOGRAPH FINAL part338 SuperValu (Equaline) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41163-215_cfaf4a87-b0cf-413a-8718-8d8a622d1256 41163-215 HUMAN OTC DRUG daytime cold and flu relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20130108 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 41163-218_1cef38e4-6aec-48f7-bf27-9f31be0a7f16 41163-218 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ASPIRIN 81 mg/1 41163-220_42467a18-a347-4713-91cd-f9e7fcf5883e 41163-220 HUMAN OTC DRUG Equaline Liquid TRICLOSAN SOAP TOPICAL 20110404 OTC MONOGRAPH NOT FINAL part333E SUPERVALU INC TRICLOSAN .15 mL/100mL 41163-220_890909af-20ed-4e5a-aba6-43a36402b7f4 41163-220 HUMAN OTC DRUG Equaline Liquid TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Supervalu Inc TRICLOSAN .15 mL/100mL 41163-224_6fb03f13-437a-4287-8dd3-23461873fbae 41163-224 HUMAN OTC DRUG Equaline Anti Diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20040903 ANDA ANDA075232 Supervalu Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 41163-226_c766bcfe-4926-423a-b77c-b7b92b25a7db 41163-226 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19921121 OTC MONOGRAPH FINAL part340 SUPERVALU INC. CAFFEINE 200 mg/1 41163-227_1a339356-fa2f-4bbe-8ae2-740880eabc40 41163-227 HUMAN OTC DRUG Equaline Pain Relief Acetaminophen TABLET, COATED ORAL 20060224 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 500 mg/1 41163-228_85585ad5-e21e-48c7-ba89-5322476d0a5c 41163-228 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20140829 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41163-229_bfd1fc86-645d-4275-ae8d-6a9b81624dc1 41163-229 HUMAN OTC DRUG Pain Relief PM extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20120919 OTC MONOGRAPH FINAL part338 EQUALINE (SuperValu) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41163-230_eaf1a48a-5533-4427-9189-c5c5a36a7d98 41163-230 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20120103 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 41163-235_8a1f9db9-3c30-4698-a0ee-7aa96854256b 41163-235 HUMAN OTC DRUG Extra Strength Pain Reliever PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41163-236_9de22368-d103-43a7-a9f5-79873ab0b591 41163-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 41163-238_967f08db-7333-47b2-949c-5eae5eb0beb1 41163-238 HUMAN OTC DRUG Stool Softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20141130 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) DOCUSATE SODIUM 100 mg/1 41163-242_6e9b64ab-c76f-4d5e-ba09-2aa09a30ff2a 41163-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH FINAL part347 EQUALINE (SuperValu) DIMETHICONE 125 mg/1 41163-244_b4e7e125-43c0-4d59-96f3-dd13a3c41f33 41163-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) DOCUSATE SODIUM 100 mg/1 41163-246_1ad59b63-e920-4a2c-965b-b62dbf2b052a 41163-246 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20131030 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41163-251_0d19e269-1dd0-4d91-bda4-40410228d045 41163-251 HUMAN OTC DRUG EQUALINE TOLNAFTATE ANTIFUNGAL TOLNAFTATE CREAM TOPICAL 20110928 OTC MONOGRAPH FINAL part333C SUPERVALU INC TOLNAFTATE 10 mg/g 41163-254_81139027-c67e-4ee8-8f7b-68baf93fb985 41163-254 HUMAN OTC DRUG equaline triple antibiotic plus bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and pramoxine hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Supervalu Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g 41163-255_ea2ba726-0199-42ae-9c60-4b068df35e64 41163-255 HUMAN OTC DRUG equaline ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20041222 ANDA ANDA075217 Supervalu Inc IBUPROFEN 50 mg/1.25mL 41163-258_f3d9bd62-9c38-40c1-a16b-c6c6eb4aef9a 41163-258 HUMAN OTC DRUG EQUALINE ETHYL ALCOHOL LIQUID TOPICAL 20120626 OTC MONOGRAPH NOT FINAL part333E SUPERVALU INC. ALCOHOL 62 mL/100mL 41163-259_4f5d8063-a4e7-48e1-b380-23970fc3e448 41163-259 HUMAN OTC DRUG EQUALINE ETHYL ALCOHOL LIQUID TOPICAL 20120626 OTC MONOGRAPH NOT FINAL part333E SUPERVALU INC. ALCOHOL 62 mL/100mL 41163-263_11a27eb5-01a4-420e-a934-7d0c1e9cc979 41163-263 HUMAN OTC DRUG Pre-moistened Hemorrhoidal Pads witch hazel SOLUTION TOPICAL 20041001 OTC MONOGRAPH FINAL part346 Supervalu Inc WITCH HAZEL .5 mL/mL 41163-264_6a243fe2-35b2-499f-8b33-2a03a0e0aafa 41163-264 HUMAN OTC DRUG EQUALINE CLOTRIMAZOLE ANTIFUNGAL CLOTRIMAZOLE CREAM TOPICAL 20110929 OTC MONOGRAPH FINAL part333C SUPERVALU INC CLOTRIMAZOLE 1 g/100g 41163-271_e6ebe9b5-4abb-4c51-b1d6-a1c68e8b835d 41163-271 HUMAN OTC DRUG Equaline Heartburn Relief Ranitidine TABLET ORAL 20090511 ANDA ANDA076760 Supervalu Inc RANITIDINE HYDROCHLORIDE 75 mg/1 41163-272_65f59e09-3388-496b-853b-b3fb03370ffb 41163-272 HUMAN OTC DRUG equaline sinus congestion and pain daytime Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20060814 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 41163-274_6119fe4b-daee-4030-96a8-4ed380fdee66 41163-274 HUMAN OTC DRUG Equaline aspirin adult low dose Aspirin TABLET, CHEWABLE ORAL 20040821 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ASPIRIN 81 mg/1 41163-279_0b8fe637-e5d7-4fb3-85e7-80b9249d096a 41163-279 HUMAN OTC DRUG Equaline Hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140905 OTC MONOGRAPH FINAL part346 Supervalu Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 41163-280_454b6a8c-a7e2-4e50-b5b9-17d3cf27da9e 41163-280 HUMAN OTC DRUG Equaline Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20100827 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-289_bef5c9b8-f636-4b10-9ef6-0467128f6874 41163-289 HUMAN OTC DRUG Equaline pain relief infants Acetaminophen SUSPENSION/ DROPS ORAL 20040830 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 80 mg/.8mL 41163-291_32d8ac56-fc77-462a-8d25-a0b409ee1659 41163-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. IBUPROFEN 200 mg/1 41163-294_bb1e0491-9ed5-455e-900b-d4423502f64e 41163-294 HUMAN OTC DRUG equaline hair regrowth treatment for men Minoxidil AEROSOL, FOAM TOPICAL 20120313 ANDA ANDA091344 Supervalu Inc MINOXIDIL 5 g/100g 41163-300_dc74aaab-8590-41d2-8dd3-8bbfa6e6c9e4 41163-300 HUMAN OTC DRUG Equaline tussin cough Dextromethorphan Hydrobromide LIQUID ORAL 20040921 OTC MONOGRAPH FINAL part341 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL 41163-302_b9a78ec4-f93b-4485-acce-2ec4525c99a1 41163-302 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090320 OTC MONOGRAPH FINAL part335 Equaline BISMUTH SUBSALICYLATE 262 mg/15mL 41163-302_c268b6fe-85cb-4430-9cea-adef4224caa6 41163-302 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090320 OTC MONOGRAPH FINAL part335 Equaline BISMUTH SUBSALICYLATE 262 mg/15mL 41163-302_fd6a79bb-0475-488a-bf2e-5249afee3917 41163-302 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090320 OTC MONOGRAPH FINAL part335 Equaline BISMUTH SUBSALICYLATE 262 mg/15mL 41163-304_354a7d2d-ac37-49d5-a0ae-dd4512ed4cb0 41163-304 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 SUPERVALU INC. MECLIZINE HYDROCHLORIDE 25 mg/1 41163-306_5933e0bf-cf3b-4c04-b87c-82cc495b2a01 41163-306 HUMAN OTC DRUG equaline clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 Supervalu Inc POLYETHYLENE GLYCOL 3350 17 g/17g 41163-310_0c3e8ce0-b4ff-4e74-a34c-477766864578 41163-310 HUMAN OTC DRUG Equaline tussin chest congestion Guaifenesin SYRUP ORAL 20041001 OTC MONOGRAPH FINAL part341 Supervalu Inc GUAIFENESIN 100 mg/5mL 41163-311_d23d17a0-bdfb-4e5e-b5f2-b4af16e27380 41163-311 HUMAN OTC DRUG Equaline Allergy relief non drowsy Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20040805 ANDA ANDA075990 Supervalu Inc LORATADINE 10 mg/1 41163-313_18470360-e28c-4692-a9d7-63d79603985a 41163-313 HUMAN OTC DRUG equaline heartburn prevention Famotidine TABLET ORAL 20090918 ANDA ANDA075400 Supervalu Inc FAMOTIDINE 10 mg/1 41163-314_abce5fcc-c22a-481f-8980-25ca450151dd 41163-314 HUMAN OTC DRUG Equaline childrens pain and fever Acetaminophen SUSPENSION ORAL 20040907 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-319_83cd9f60-a4c4-4dea-97a7-cd96aade9e88 41163-319 HUMAN OTC DRUG equaline anti itch Hydrocortisone CREAM TOPICAL 20101117 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc HYDROCORTISONE 1 g/100g 41163-320_3d8cd58b-d760-4ffd-b39c-615c64d5d93d 41163-320 HUMAN OTC DRUG DAILY MOISTURIZING WITH NATURAL COLLOIDAL OATMEAL DIMETHICONE LOTION TOPICAL 20100721 OTC MONOGRAPH FINAL part347 SUPERVALU INC DIMETHICONE 1.25 mL/100mL 41163-320_d2cd35fc-2c0f-4f89-b1a7-477813ceea23 41163-320 HUMAN OTC DRUG DAILY MOISTURIZING WITH NATURAL COLLOIDAL OATMEAL DIMETHICONE LOTION TOPICAL 20100625 OTC MONOGRAPH FINAL part347 SUPERVALU INC DIMETHICONE 1.25 mL/100mL 41163-321_ea570e00-ea36-4161-acc7-3eb3de477ad3 41163-321 HUMAN OTC DRUG equaline complete dual action famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080902 ANDA ANDA077355 Supervalu Inc CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 41163-323_2bfe5eb6-04c5-4575-9192-a0be335b7097 41163-323 HUMAN OTC DRUG equaline naproxen sodium Naproxen sodium TABLET, FILM COATED ORAL 20140714 ANDA ANDA074661 Supervalu Inc NAPROXEN SODIUM 220 mg/1 41163-328_3c3a77d2-fa13-4c40-aa5c-8f1acc7a8226 41163-328 HUMAN OTC DRUG equaline sore throat Phenol SPRAY ORAL 20040830 OTC MONOGRAPH NOT FINAL part356 Supervalu Inc PHENOL 1.4 g/100mL 41163-329_30f43c22-bcb7-47e7-bb2a-efe51ba979b2 41163-329 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 SUPERVALU INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41163-332_d446ad1b-10af-4829-9419-0ecd047d26d9 41163-332 HUMAN OTC DRUG Equaline milk of magnesia Magnesium hydroxide LIQUID ORAL 20041014 OTC MONOGRAPH NOT FINAL part334 Supervalu Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 41163-333_4ee4019f-504c-4cdb-931f-c3f5544d35e0 41163-333 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041122 ANDA ANDA076200 SUPERVALU INC. ACETAMINOPHEN 650 mg/1 41163-335_5e1cd969-7130-4ab1-a475-1dad6af1d966 41163-335 HUMAN OTC DRUG equaline nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20111017 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 41163-336_858cc5c1-fa49-4d6b-98b4-608d507d03a2 41163-336 HUMAN OTC DRUG Acetaminophen 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130813 ANDA ANDA076200 Supervalu Inc. ACETAMINOPHEN 650 mg/1 41163-337_30b7bf13-de63-4a11-8f8c-66bec7e3c72d 41163-337 HUMAN OTC DRUG Peptic Relief Maximum Strength BISMUTH SUBSALICYLATE SUSPENSION ORAL 20090402 OTC MONOGRAPH FINAL part341 Equaline BISMUTH SUBSALICYLATE 525 mg/15mL 41163-337_5a2f324a-3ed5-462d-ba0f-236291e4fa22 41163-337 HUMAN OTC DRUG Peptic Relief Maximum Strength BISMUTH SUBSALICYLATE SUSPENSION ORAL 20090320 OTC MONOGRAPH FINAL part341 Equaline BISMUTH SUBSALICYLATE 525 mg/15mL 41163-341_43edca8f-954b-4166-990d-e384ca795947 41163-341 HUMAN OTC DRUG equaline athletes foot Miconazole Nitrate SPRAY TOPICAL 20040911 OTC MONOGRAPH FINAL part333C Supervalu Inc MICONAZOLE NITRATE 2 g/100g 41163-344_f986a112-0ae8-4a70-980b-9f5b514cd0aa 41163-344 HUMAN OTC DRUG equaline nicotine Nicotine Polacrilex LOZENGE ORAL 20060328 ANDA ANDA077007 Supervalu Inc NICOTINE 2 mg/1 41163-346_aa3c2320-515b-4d12-a142-e8f161e70bf8 41163-346 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate CAPSULE ORAL 20110506 OTC MONOGRAPH FINAL part335 SUPERVALU INC. BISMUTH SUBSALICYLATE 262 mg/1 41163-352_2523926b-e4ee-4b45-a485-24b294998874 41163-352 HUMAN OTC DRUG equaline nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20080917 ANDA ANDA078547 Supervalu Inc NICOTINE 2 mg/1 41163-356_fb0e0184-b1b7-4bfb-82bb-e3a13e8a4354 41163-356 HUMAN OTC DRUG EQUALINE ALL DAY MOISTURIZER OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 SUPERVALU INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 30; 50; 26 mg/mL; mg/mL; mg/mL; mg/mL 41163-357_826a4fef-8808-4d2d-bf2c-11bfae6d1b75 41163-357 HUMAN OTC DRUG Equaline Antacid regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20041027 OTC MONOGRAPH FINAL part332 Supervalu Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 41163-358_d87439aa-11fa-4cf6-b878-1a41f49e27cf 41163-358 HUMAN OTC DRUG EQUALINE DIMETHICONE LOTION TOPICAL 20130115 OTC MONOGRAPH FINAL part347 SUPERVALU INC. DIMETHICONE 13 mg/mL 41163-358_f930ddf1-1c2e-4c47-90e5-651dfa9f9b00 41163-358 HUMAN OTC DRUG EQUALINE DIMETHICONE LOTION TOPICAL 20130115 OTC MONOGRAPH FINAL part347 SUPERVALU INC. DIMETHICONE 13 mg/mL 41163-359_f4c0a930-0b80-4a43-984d-3bc339299b34 41163-359 HUMAN OTC DRUG Equaline tussin adult Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20040824 OTC MONOGRAPH FINAL part341 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 41163-361_21e51c8c-aaf2-4ed2-a414-e8dd52134d3b 41163-361 HUMAN OTC DRUG Equaline Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20131028 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-367_6aba8be7-2103-42e2-bfa3-93b5212dfc6b 41163-367 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20000610 OTC MONOGRAPH FINAL part338 SUPERVALU INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41163-368_c865bd73-eb89-4d25-b88c-214867c8f715 41163-368 HUMAN OTC DRUG equaline all day pain relief Naproxen Sodium TABLET, FILM COATED ORAL 20040810 ANDA ANDA074661 Supervalu Inc NAPROXEN SODIUM 220 mg/1 41163-369_adae3898-e77f-41b5-a508-54974294e0b8 41163-369 HUMAN OTC DRUG equaline anti itch maximum strength Hydrocortisone CREAM TOPICAL 20110225 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc HYDROCORTISONE 1 g/100g 41163-370_ab5e917d-068b-4a59-b16d-aa447e92470b 41163-370 HUMAN OTC DRUG Aspirin regular strength Aspirin TABLET, COATED ORAL 20111205 OTC MONOGRAPH FINAL part343 SuperValu (Equaline) ASPIRIN 325 mg/1 41163-371_373598ac-d64a-4c8a-a7e5-5a14c2dbc62b 41163-371 HUMAN OTC DRUG equaline daytime cold multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20110303 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 41163-373_ae2fcc80-5a26-4f7d-99f5-aebf6f25469c 41163-373 HUMAN OTC DRUG Headache Formula PM Acetaminophen and Diphenhydramine Citrate TABLET ORAL 20040607 OTC MONOGRAPH FINAL part341 SUPERVALU INC. ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 41163-374_06af9b74-4077-40a2-a25a-854952930641 41163-374 HUMAN OTC DRUG Equaline migraine formula Acetaminophen, Aspirin, Caffeine TABLET ORAL 20040903 ANDA ANDA075794 Supervalu Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 41163-375_02ac8d85-40da-497e-b1d4-94c028d7fe7c 41163-375 HUMAN OTC DRUG Anti-Diarrheal Loperamides TABLET ORAL 20050503 ANDA ANDA076497 SUPERVALU INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 41163-379_78ecfa3b-62a7-463a-9b12-5a3a6309bf61 41163-379 HUMAN OTC DRUG equaline allergy Diphenhydramine HCl SOLUTION ORAL 20040810 OTC MONOGRAPH FINAL part341 Supervalu Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 41163-381_3069cea0-f552-4f4a-9d38-b601e38d8a35 41163-381 HUMAN OTC DRUG Equaline Mucus Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20131212 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 41163-384_996f9b62-2656-4a6e-8d69-968c6cf87c13 41163-384 HUMAN OTC DRUG equaline cough dm dextromethorphan polistirex SUSPENSION ORAL 20121019 ANDA ANDA091135 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 41163-386_2beead38-7212-43ef-9ef8-3df9356498d2 41163-386 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 SUPERVALU INC. DOXYLAMINE SUCCINATE 25 mg/1 41163-388_c0241ac5-394e-4994-9d0d-421730959534 41163-388 HUMAN OTC DRUG equaline tussin multi symptom Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20140711 OTC MONOGRAPH FINAL part341 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 41163-390_5e4bfb16-800a-490a-9802-93d866b7670f 41163-390 HUMAN OTC DRUG Maximum Strength Menstrual Relief Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 41163-392_d75f47e5-c3f7-4f5c-95b3-f174c8f328b9 41163-392 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20020330 ANDA ANDA075139 SUPERVALU INC. IBUPROFEN 200 mg/1 41163-393_5c8a8e52-1728-4561-a86b-3e178589c6b4 41163-393 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20020408 ANDA ANDA075139 SUPERVALU INC. IBUPROFEN 200 mg/1 41163-394_13928209-8ad7-4b9a-b038-cb4b5fa0bb14 41163-394 HUMAN OTC DRUG Equaline Hemorrhoidal Cocoa butter, Phenylephrine HCl, Shark liver oil SUPPOSITORY RECTAL 20040923 OTC MONOGRAPH FINAL part346 Supervalu Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2137.5; 75; 6.375 mg/1; mg/1; mg/1 41163-396_e21c6b53-432d-44f8-8af8-6a4b7c315b6d 41163-396 HUMAN OTC DRUG equaline milk of magnesia Magnesium hydroxide LIQUID ORAL 20041014 OTC MONOGRAPH NOT FINAL part334 Supervalu Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 41163-397_410820ff-983b-4018-ac44-9f1ff7c08db0 41163-397 HUMAN OTC DRUG Chewable Adult Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 20010904 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ASPIRIN 81 mg/1 41163-400_c8543264-4b5f-489f-913f-e148bd49133b 41163-400 HUMAN OTC DRUG equaline hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 20041116 OTC MONOGRAPH FINAL part346 Supervalu Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 41163-401_d5ef6eba-86d0-4257-8b14-e2aac190d9b6 41163-401 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET ORAL 20121031 OTC MONOGRAPH FINAL part336 SuperValu (Equaline) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41163-402_61a93749-cde8-44db-bd7b-11a83c19d4b3 41163-402 HUMAN OTC DRUG Equaline Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20141014 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-403_5c631f9b-ca18-49cf-9b79-2a5c162ba1ea 41163-403 HUMAN OTC DRUG equaline pain relief Acetaminophen TABLET ORAL 20040828 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 325 mg/1 41163-404_f3a4b663-b205-4c28-b90c-013dd6144e78 41163-404 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET, CHEWABLE ORAL 20020529 OTC MONOGRAPH FINAL part336 SUPERVALU INC. MECLIZINE HYDROCHLORIDE 25 mg/1 41163-407_cdd6eec0-acfc-4f29-8cf6-90a70c5bec98 41163-407 HUMAN OTC DRUG Equaline Cold Sore Treatment Camphor CREAM TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g 41163-409_181daead-a9d8-49ff-ac2d-05351b60c42e 41163-409 HUMAN OTC DRUG Equaline Stay Awake Caffeine TABLET ORAL 20040830 OTC MONOGRAPH FINAL part340 Supervalu Inc CAFFEINE 200 mg/1 41163-411_92f41a10-fefc-4463-b1e2-3ee34f605cd6 41163-411 HUMAN OTC DRUG Cough and Cold Relief HBP Chlorpheniramine maleate and Dextromethorphan HBr TABLET ORAL 20030503 OTC MONOGRAPH FINAL part341 SUPERVALU INC. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 41163-412_edf7a703-e3c5-4158-943f-5a5550b48679 41163-412 HUMAN OTC DRUG EQUALINE MEDICATED WIPES WITCH HAZEL CLOTH TOPICAL 20111003 OTC MONOGRAPH FINAL part346 SUPERVALU INC WITCH HAZEL 5 g/1 41163-413_09a9a26f-f8a8-4372-bd5b-642575cb731c 41163-413 HUMAN OTC DRUG Equaline Dandruff Classic Clean PYRITHIONE ZINC SHAMPOO TOPICAL 20100916 OTC MONOGRAPH FINAL part358H Supervalu Inc PYRITHIONE ZINC 1 mL/100mL 41163-413_c3af3961-c506-4fd9-9729-acc8e065728c 41163-413 HUMAN OTC DRUG Equaline Dandruff Classic Clean PYRITHIONE ZINC SHAMPOO TOPICAL 20100916 OTC MONOGRAPH FINAL part358H Supervalu Inc PYRITHIONE ZINC 1 mL/100mL 41163-414_4997c58f-f427-4625-836d-1dc09336168d 41163-414 HUMAN OTC DRUG Adult Low strength Aspirin Aspirin TABLET, COATED ORAL 20040114 20151015 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ASPIRIN 81 mg/1 41163-415_d4a2280d-e31e-47a0-b130-30c9b253eaf3 41163-415 HUMAN OTC DRUG CLASSIC CLEAN 2 IN 1 FOR NORMAL HAIR PYRITHIONE ZINC SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358H SUPERVALU INC PYRITHIONE ZINC 1 mL/100mL 41163-416_671b28f4-37aa-45a9-8d1d-0d310f305931 41163-416 HUMAN OTC DRUG Equaline Aspirin Aspirin TABLET ORAL 20040813 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ASPIRIN 325 mg/1 41163-417_020dffaa-e604-4bcc-aed6-cbe8cf088049 41163-417 HUMAN OTC DRUG EQUALINE CLASSIC CLEAN 2 IN 1 PYRITHIONE ZINC LIQUID TOPICAL 20130214 OTC MONOGRAPH FINAL part358H SUPERVALU INC. PYRITHIONE ZINC 10 mg/mL 41163-418_7a9624ff-65e7-4cbb-bc3f-cea0a6dfc521 41163-418 HUMAN OTC DRUG Equaline Dandruff Dry Scalp 2 in 1 PYRITHIONE ZINC SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358H SUPERVALU INC PYRITHIONE ZINC 1 mL/100mL 41163-420_e961aac9-c831-49b1-ba12-71389e191175 41163-420 HUMAN OTC DRUG OCEAN BREEZE 2 IN 1 DANDRUFF SEA MINERAL SCENT PYRITHIONE ZINC SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358H SUPERVALU INC PYRITHIONE ZINC 1 mL/100mL 41163-422_04258fb7-a06a-4656-9902-966b3a879218 41163-422 HUMAN OTC DRUG Equaline Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20080908 ANDA ANDA078326 Supervalu Inc NICOTINE 4 mg/1 41163-423_c2c4e7fa-7f12-4b28-9afc-e99076de098d 41163-423 HUMAN OTC DRUG Equaline Dandruff Refresh PYRITHIONE ZINC SHAMPOO TOPICAL 20100916 OTC MONOGRAPH FINAL part358H Supervalu Inc PYRITHIONE ZINC 1 mL/100mL 41163-424_c0db6811-124a-417c-87c5-2c13130c1a99 41163-424 HUMAN OTC DRUG EQUALINE CLASSIC CLEAN 2 IN 1 PYRITHIONE ZINC LIQUID TOPICAL 20140226 OTC MONOGRAPH FINAL part358H SUPERVALU INC PYRITHIONE ZINC 10 mg/mL 41163-425_5c8348b6-2fcc-4e02-8dfb-6f7eb9b1b329 41163-425 HUMAN OTC DRUG EQUALINE DRY SCALP 2 IN 1 PYRITHIONE ZINE LIQUID TOPICAL 20140731 OTC MONOGRAPH FINAL part358H SUPERVALU INC PYRITHIONE ZINC 10 mg/mL 41163-426_b3ac6c07-a06e-43eb-83ed-379a8a0ce200 41163-426 HUMAN OTC DRUG Childrens allergy relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Supervalu Inc LORATADINE 5 mg/5mL 41163-427_26c313b9-fd6b-4e2f-96f7-70a2707faf89 41163-427 HUMAN OTC DRUG EQUALINE CLASSIC CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20131231 OTC MONOGRAPH FINAL part358H SUPERVALU INC PYRITHIONE ZINC 10 mg/mL 41163-427_946dd410-4a62-4489-8dd4-8ba6886df51c 41163-427 HUMAN OTC DRUG EQUALINE CLASSIC CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20140731 OTC MONOGRAPH FINAL part358H SUPERVALU INC PYRITHIONE ZINC 10 mg/mL 41163-428_e5fd551a-2e51-47bd-a52e-abdf91260a04 41163-428 HUMAN OTC DRUG equaline antibiotic plus pain relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Supervalu Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g 41163-430_8f2a3044-8827-4438-a8c0-9e7662f6ea50 41163-430 HUMAN OTC DRUG Equaline headache formula added strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20040830 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 41163-432_840947c2-aeed-4e4b-b787-36654d95b890 41163-432 HUMAN OTC DRUG equaline nasal decongestant non drowsy maximum strength Pseudoephedrine HCl TABLET, FILM COATED ORAL 20040817 OTC MONOGRAPH FINAL part341 Supervalu Inc PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 41163-434_5182774d-9ee3-41c7-89b5-d0885badca6a 41163-434 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19980414 OTC MONOGRAPH FINAL part340 SUPERVALU INC. CAFFEINE 200 mg/1 41163-437_fb5a7788-0a4c-4e69-b3af-54f5e3d3a81a 41163-437 HUMAN OTC DRUG equaline pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20040830 OTC MONOGRAPH FINAL part338 Supervalu Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41163-441_6379013a-b473-4c77-ad82-cf438b411b21 41163-441 HUMAN OTC DRUG Equaline Sleep Aid Doxylamine succinate TABLET ORAL 20040810 ANDA ANDA040167 Supervalu Inc DOXYLAMINE SUCCINATE 25 mg/1 41163-445_84767482-65cd-41a3-ae50-8ccd38c96950 41163-445 HUMAN OTC DRUG equaline flu and severe cold and cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20140321 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 41163-449_105f8906-836b-4038-8c3d-9d821dc379e9 41163-449 HUMAN OTC DRUG Junior Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN 160 mg/1 41163-450_db21ef83-657d-4d16-a441-4c1c82dffe1f 41163-450 HUMAN OTC DRUG Junior Acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN 160 mg/1 41163-453_4f63570a-6edc-4850-8837-6444b60a0564 41163-453 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 SUPERVALU INC. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 41163-456_7e89eca7-c6cc-446b-a490-45954c3227df 41163-456 HUMAN OTC DRUG Equaline Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20080917 ANDA ANDA076777 Supervalu Inc NICOTINE 2 mg/1 41163-458_832252e5-1935-4da8-b15b-3bf00bf3ddf4 41163-458 HUMAN OTC DRUG Equaline all day allergy Cetirizine Hydrochloride TABLET ORAL 20080123 ANDA ANDA078336 Supervalu Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 41163-459_2ef27848-06a3-4d2f-beee-ca021e21d0d5 41163-459 HUMAN OTC DRUG equaline nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20111024 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 41163-462_0fac2a90-d087-458f-8330-49a8f7e6808c 41163-462 HUMAN OTC DRUG equaline allergy diphenhydramine hydrochloride CAPSULE ORAL 20040810 OTC MONOGRAPH FINAL part341 Supervalu Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41163-463_177fa4f3-6966-48ff-9023-e96bce71346b 41163-463 HUMAN OTC DRUG Equaline Allergy Chlorpheniramine Maleate TABLET ORAL 20040830 OTC MONOGRAPH FINAL part341 Supervalu Inc CHLORPHENIRAMINE MALEATE 4 mg/1 41163-466_5cf74f4f-195d-4d5e-a89c-a574f4b0ff59 41163-466 HUMAN OTC DRUG equaline laxative bisacodyl SUPPOSITORY RECTAL 20120924 OTC MONOGRAPH NOT FINAL part334 Supervalu Inc BISACODYL 10 mg/1 41163-467_54dd8ed5-75ef-4fde-b31a-ca3a3def598b 41163-467 HUMAN OTC DRUG Equaline Aspirin Aspirin TABLET, CHEWABLE ORAL 20040830 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ASPIRIN 81 mg/1 41163-468_f39bd219-9825-460b-a3ee-ee96fdaa2989 41163-468 HUMAN OTC DRUG equaline antacid Calcium carbonate TABLET, CHEWABLE ORAL 20041014 OTC MONOGRAPH FINAL part331 Supervalu Inc CALCIUM CARBONATE 750 mg/1 41163-470_e937fd1b-4c97-4b8c-a993-6a4a985d33b8 41163-470 HUMAN OTC DRUG Daytime Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140501 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 41163-471_ef9ea069-9b97-4bf5-aaac-deb85334dbd0 41163-471 HUMAN OTC DRUG equaline anti itch hydrocortisone OINTMENT TOPICAL 20101203 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc HYDROCORTISONE 1 g/100g 41163-473_1e0cbb47-08f6-4afb-ad5a-6ce1b262ab97 41163-473 HUMAN OTC DRUG equaline childrens acetaminophen Acetaminophen SUSPENSION ORAL 20141015 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-478_a498a5f3-10a7-48ae-829a-b923a29bb0d8 41163-478 HUMAN OTC DRUG equaline antacid regular strength calcium carbonate TABLET, CHEWABLE ORAL 20040928 OTC MONOGRAPH FINAL part331 Supervalu Inc CALCIUM CARBONATE 500 mg/1 41163-479_d48a38e6-e85b-4c5d-8ea0-74e2c0b2f607 41163-479 HUMAN OTC DRUG equaline allergy Diphenhydramine Hydrochloride TABLET ORAL 20040830 OTC MONOGRAPH FINAL part341 Supervalu Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41163-480_a2b4a1e3-3db2-4d0d-9cbe-7319d1bf9312 41163-480 HUMAN OTC DRUG Nighttime Cold and Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20140501 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 41163-484_aec8926e-de81-4987-8fd5-54893e35853c 41163-484 HUMAN OTC DRUG Equaline pain relief extra strength Acetaminophen TABLET ORAL 20040818 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 500 mg/1 41163-485_98983baf-35bd-499b-8749-4d3988b4b370 41163-485 HUMAN OTC DRUG equaline antacid calcium carbonate TABLET, CHEWABLE ORAL 20050104 OTC MONOGRAPH FINAL part331 Supervalu Inc CALCIUM CARBONATE 500 mg/1 41163-488_4025f145-dc24-488e-a079-c5ac79992cfc 41163-488 HUMAN OTC DRUG EQUALINE BLUE ICE PAIN RELIEVING MENTHOL GEL TOPICAL 20111003 OTC MONOGRAPH FINAL part348 SUPERVALU INC MENTHOL 2 g/100g 41163-489_41c20c6d-adf3-47c8-9d1a-90205f120836 41163-489 HUMAN OTC DRUG equaline antacid Calcium carbonate TABLET, CHEWABLE ORAL 20041001 OTC MONOGRAPH FINAL part331 Supervalu Inc CALCIUM CARBONATE 750 mg/1 41163-490_961219ab-6bab-443a-bf9e-4c68186362b3 41163-490 HUMAN OTC DRUG equaline all day pain relief Naproxen Sodium TABLET ORAL 20040810 ANDA ANDA074661 Supervalu Inc NAPROXEN SODIUM 220 mg/1 41163-491_a1ffc116-aa15-4638-ac4c-71191fb7bb94 41163-491 HUMAN OTC DRUG Daytime Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20140501 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) 41163-496_463f7b25-f0ff-4ba6-9dce-2032a2c18e1f 41163-496 HUMAN OTC DRUG equaline daytime and nighttime cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20090903 OTC MONOGRAPH FINAL part341 Supervalu Inc 41163-498_258fb04e-1b9f-46dd-9893-2210e14ed58c 41163-498 HUMAN OTC DRUG Equaline Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130806 ANDA ANDA078912 Supervalu Inc GUAIFENESIN 600 mg/1 41163-499_f83964aa-3c4f-4db6-9c55-ef138ca67dbb 41163-499 HUMAN OTC DRUG Equaline Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20141014 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-501_2e622bb7-22d4-4630-83c5-90ce5cbb6e6f 41163-501 HUMAN OTC DRUG Equaline Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20120228 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-502_07c91d1c-1f41-4a19-83e7-c27025f8f1b9 41163-502 HUMAN OTC DRUG Sinus Headache PE Acetaminophen and Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 41163-503_81e9f291-66a7-4aca-98a1-d254f2cec505 41163-503 HUMAN OTC DRUG Day Time Cold Multi-Symptom Severe Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED ORAL 20050804 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 41163-511_1022d075-9bdf-46df-81ac-c84cb2608195 41163-511 HUMAN OTC DRUG equaline naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20140924 ANDA ANDA074661 Supervalu Inc NAPROXEN SODIUM 220 mg/1 41163-516_1c19b9f7-7696-48e2-842a-b9a2072269e9 41163-516 HUMAN OTC DRUG equaline tussin cough and cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20060629 OTC MONOGRAPH FINAL part341 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 41163-517_b70b01c4-084e-4a7d-bffb-63a3e153324d 41163-517 HUMAN OTC DRUG Equaline ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060428 ANDA ANDA077349 Supervalu Inc IBUPROFEN 200 mg/1 41163-519_ceb7a400-b18e-434b-8d2d-350b5f94eacd 41163-519 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN 500 mg/1 41163-521_7444a0aa-6c97-4919-ba57-368992af988e 41163-521 HUMAN OTC DRUG equaline ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20110504 ANDA ANDA076359 Supervalu Inc IBUPROFEN 100 mg/1 41163-526_5c942067-b8bf-49af-bde8-712d558bb304 41163-526 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 SUPERVALU INC. LORATADINE 10 mg/1 41163-527_27f89b26-59d0-4d2e-ab26-f6cb237570cb 41163-527 HUMAN OTC DRUG Sinus Congestion and Pain Severe Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, COATED ORAL 20050806 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 41163-528_35af7285-9558-4f37-a826-594676f46763 41163-528 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20131203 ANDA ANDA077153 Supervalu Inc. LORATADINE 10 mg/1 41163-529_91e3580a-fa27-46e4-a93f-b180a968335c 41163-529 HUMAN OTC DRUG Head Congestion Daytime and Nighttime Cold Acetaminophen, Chlorpehniramine HCl, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 SUPERVALU INC. 41163-530_c065cb41-f588-4fe0-8d3a-48895b935264 41163-530 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20141130 OTC MONOGRAPH FINAL part347 EQUALINE (SuperValu) DIMETHICONE 180 mg/1 41163-531_5b98abdf-599a-4c79-b7fc-624262160d0d 41163-531 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen TABLET ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN 500 mg/1 41163-532_183788ec-8da6-49a8-8cdb-6237339b40a0 41163-532 HUMAN OTC DRUG equaline nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20080917 ANDA ANDA076779 Supervalu Inc NICOTINE 4 mg/1 41163-544_24f8e541-e62e-4ee1-b21a-aaf555ca8556 41163-544 HUMAN OTC DRUG equaline arthritis Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120829 ANDA ANDA075077 Supervalu Inc ACETAMINOPHEN 650 mg/1 41163-546_288e1746-be64-40c6-a426-2367b457b8b3 41163-546 HUMAN OTC DRUG equaline complete dual action Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080902 ANDA ANDA077355 Supervalu Inc CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 41163-549_78793623-61ad-42cf-9cdd-71c5f10a8c53 41163-549 HUMAN OTC DRUG Equaline Lice Treatment Piperonyl Butoxide, Pyrethrum Extract RINSE TOPICAL 20071116 OTC MONOGRAPH FINAL part358 Supervalu Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL 41163-550_58aee658-5b29-4d15-b6b8-f0d65c99e510 41163-550 HUMAN OTC DRUG Gas relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100708 OTC MONOGRAPH FINAL part332 SuperValu (Equaline) DIMETHICONE 125 mg/1 41163-551_17af0b3d-61e4-4c1a-be6d-100c10f28d17 41163-551 HUMAN OTC DRUG equaline nighttime cough relief Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20140520 OTC MONOGRAPH FINAL part341 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 41163-556_4ab65f28-7753-4f39-8d95-018a9242bda2 41163-556 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41163-557_e98356f0-18d5-4e2c-a87b-a485636b8aed 41163-557 HUMAN OTC DRUG equaline hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20130216 OTC MONOGRAPH FINAL part346 Supervalu Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g 41163-560_dcbbecbd-dd21-4597-abd9-c41171851b14 41163-560 HUMAN OTC DRUG Cold Multi-Symptom Daytime Rapid Release Acetaminophen, Phenylephrine HCl and Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20080329 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 41163-561_5b5234a6-8340-44d2-af6d-ef8307d46671 41163-561 HUMAN OTC DRUG equaline ibuprofen pm Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20120111 ANDA ANDA079113 Supervalu Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 41163-563_1c66010f-f0c7-494d-9cff-858183b89c19 41163-563 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ASPIRIN 81 mg/1 41163-567_464b1f48-214c-45bc-8f94-17d86752fbb6 41163-567 HUMAN OTC DRUG equaline daytime and nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120814 OTC MONOGRAPH FINAL part341 Supervalu Inc 41163-571_6ce50192-fc8f-43df-aadf-88c6e996c47b 41163-571 HUMAN OTC DRUG equaline aller ease fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Supervalu Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 41163-578_9d4ad556-bc82-4817-a175-bae182aca4a6 41163-578 HUMAN OTC DRUG Equaline adult tussin cough and chest congestion Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20041001 OTC MONOGRAPH FINAL part341 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 41163-580_d0702850-36ce-4290-886e-f32e72490eed 41163-580 HUMAN OTC DRUG Equaline Daytime Nighttime Cold and Flu Relief Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140524 OTC MONOGRAPH FINAL part341 Supervalu Inc 41163-588_29e2ff3b-ceec-4015-b681-6695816b150b 41163-588 HUMAN OTC DRUG equaline antacid Aluminum Hydroxide, Magnesium Hydroxide, Simethicone LIQUID ORAL 20120911 OTC MONOGRAPH FINAL part332 Supervalu Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 41163-590_3ac7149a-ee84-4d50-a94d-11adb06b4efd 41163-590 HUMAN OTC DRUG equaline infants pain and fever acetaminophen LIQUID ORAL 20120801 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-595_356abd8f-c8dc-4ac6-acfa-bcb9e379fc20 41163-595 HUMAN OTC DRUG Equaline antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20041022 OTC MONOGRAPH FINAL part331 Supervalu Inc CALCIUM CARBONATE 1000 mg/1 41163-600_02b19c0e-f62a-4d48-a41c-a6d820591e0d 41163-600 HUMAN OTC DRUG Equaline Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 20041007 OTC MONOGRAPH FINAL part335 Supervalu Inc BISMUTH SUBSALICYLATE 1050 mg/30mL 41163-602_8a3132db-880f-425b-afce-ea7a81ed3650 41163-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20050321 OTC MONOGRAPH NOT FINAL part334 supervalu Inc. MAGNESIUM SULFATE 1 g/g 41163-603_c586336d-8a90-4189-aff0-21b24800f54e 41163-603 HUMAN OTC DRUG equaline daytime severe cold and flu relief acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20140728 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 41163-604_ab95bdec-8c0d-43dd-90fd-bd0bc64c228d 41163-604 HUMAN OTC DRUG equaline ibuprofen Ibuprofen TABLET ORAL 20040805 ANDA ANDA072096 Supervalu Inc IBUPROFEN 200 mg/1 41163-607_2daf9588-1454-4208-ab4a-b21f538fe2c4 41163-607 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET, COATED ORAL 20130401 OTC MONOGRAPH NOT FINAL part334 SUPERVALU INC. BISACODYL 5 mg/1 41163-609_dad6d65a-e7a6-421a-81a8-6696eb5958f5 41163-609 HUMAN OTC DRUG Equaline infants acetaminophen Acetaminophen SUSPENSION ORAL 20141022 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-610_a4694068-2e84-4840-91cb-8389f4feed63 41163-610 HUMAN OTC DRUG EQUALINE MEDICATED DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20100929 OTC MONOGRAPH FINAL part358H SUPERVALU INC SELENIUM SULFIDE 1 mL/100mL 41163-611_f80715b8-43c9-4aeb-8d8d-cc5fa1162cd4 41163-611 HUMAN OTC DRUG Equaline Moisturizing Dandruff Medicated Formula Selenium Sulfide SHAMPOO TOPICAL 20101015 OTC MONOGRAPH FINAL part358H Supervalu Inc SELENIUM SULFIDE 1 mL/100mL 41163-612_4f51cf93-c7d1-469c-97a5-fb08e84af1d7 41163-612 HUMAN OTC DRUG Equaline Allergy Relief Loratadine TABLET ORAL 20050207 ANDA ANDA076301 Supervalu Inc LORATADINE 10 mg/1 41163-616_ec00ffdc-5f01-4a94-99ba-89fcccf0c171 41163-616 HUMAN OTC DRUG EQUALINE MOISTURIZING DANDRUFF SELENUM SULFIDE SHAMPOO TOPICAL 20120323 OTC MONOGRAPH FINAL part358H SUPERVALU INC. SELENIUM SULFIDE 1 mL/100mL 41163-617_9c38a377-e59a-4225-bbb2-31ac5fdde1d6 41163-617 HUMAN OTC DRUG EQUALINE MEDICATED DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20120430 OTC MONOGRAPH FINAL part358H SUPERVALU INC. SELENIUM SULFIDE 1 mL/100mL 41163-618_990ce740-8c8f-40bd-aa96-6d60a1eff961 41163-618 HUMAN OTC DRUG EQUALINE CLINICAL STRENGTH SELENIUM SULFIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH FINAL part358H SUPERVALU INC. SELENIUM SULFIDE 10 mg/mL 41163-619_0db52362-b08a-409e-a35a-ca29ed1732d0 41163-619 HUMAN OTC DRUG Heartburn Relief Ranitidine TABLET ORAL 20130615 ANDA ANDA200536 SUPERVALU INC. RANITIDINE HYDROCHLORIDE 75 mg/1 41163-620_96d220be-278c-4e69-b011-8a3720bb5fa2 41163-620 HUMAN OTC DRUG EQUALINE MENTHOL SELENIUM SULFIDE LIQUID TOPICAL 20130610 OTC MONOGRAPH FINAL part358H SUPERVALU INC. SELENIUM SULFIDE 10 mg/mL 41163-621_4d835403-638b-4d50-85a1-3cc51cae857b 41163-621 HUMAN OTC DRUG EQUALINE ALOE SELENIUM SULFIDE LIQUID TOPICAL 20130610 OTC MONOGRAPH FINAL part358H SUPERVALU INC. SELENIUM SULFIDE 10 mg/mL 41163-622_259ea676-9fe5-4963-970d-42064f471e8d 41163-622 HUMAN OTC DRUG Equaline Anti Itch Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20140328 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 41163-629_18bbd108-9005-43cc-bd70-d394afd50dcb 41163-629 HUMAN OTC DRUG Stool Softener plus Stimulant Laxative Docusate sodium and Sennosides TABLET ORAL 20100915 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 41163-630_1485e4d9-6d36-41a5-b4e1-9f65b59afb0c 41163-630 HUMAN OTC DRUG equaline anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 20040928 UNAPPROVED DRUG OTHER Supervalu Inc DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 41163-645_9e2d7ce2-a6ab-4002-a649-c9645d03f184 41163-645 HUMAN OTC DRUG Equaline loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120206 ANDA ANDA091292 Supervalu Inc LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 41163-647_cf8fe431-7231-489d-a12f-5ca17249d2f1 41163-647 HUMAN OTC DRUG equaline ibuprofen Ibuprofen TABLET, COATED ORAL 20040817 ANDA ANDA072096 Supervalu Inc IBUPROFEN 200 mg/1 41163-652_677775f3-920d-4084-a2c2-b77266153856 41163-652 HUMAN OTC DRUG Severe Cold PE Multi-Symptom Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET, FILM COATED ORAL 20050621 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 41163-656_540dcd7c-856b-4d4a-91f2-68aadebcd38c 41163-656 HUMAN OTC DRUG equaline daytime cold and flu relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20111012 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 41163-660_7513b738-e7c5-40ec-965d-56413e174648 41163-660 HUMAN OTC DRUG Equaline Ibuprofen childrens Ibuprofen SUSPENSION ORAL 20040924 ANDA ANDA074937 Supervalu Inc IBUPROFEN 100 mg/5mL 41163-664_b8266074-8041-47fb-af80-39749653c374 41163-664 HUMAN OTC DRUG Sinus Congestion and Pain Acetaminophen and Phenylephrine HCl TABLET ORAL 20050726 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN 325 mg/1 41163-667_2a092d39-a9db-4e2a-af82-f632a495c411 41163-667 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 20011118 OTC MONOGRAPH NOT FINAL part334 Supervalue, INC MAGNESIUM CITRATE 1.745 g/29.61mL 41163-668_25c79b63-a764-4258-8678-36c4a3546689 41163-668 HUMAN OTC DRUG Equaline night time cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20040921 OTC MONOGRAPH FINAL part341 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 41163-678_2e50ded3-03f6-46cc-99c6-3ccf8d6d64f6 41163-678 HUMAN OTC DRUG Equaline hemorrhoial Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20121111 OTC MONOGRAPH FINAL part346 Supervalu Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 41163-679_84c83402-d400-4edf-93c1-f8dfc19c146e 41163-679 HUMAN OTC DRUG equaline triple antibiotic Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20120417 OTC MONOGRAPH FINAL part333B Supervalu Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 41163-685_6d8b80be-a988-4d1d-8659-375c56b4a863 41163-685 HUMAN OTC DRUG Equaline Ibuprofen Ibuprofen LIQUID ORAL 20100927 ANDA ANDA074937 Supervalu Inc IBUPROFEN 100 mg/5mL 41163-689_6ab31c85-4051-4769-82d7-e10f5a28040f 41163-689 HUMAN OTC DRUG equaline childrens pain and fever acetaminophen SUSPENSION ORAL 20140313 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-690_9588b6a3-40a1-49c5-bbbf-b80622535dfc 41163-690 HUMAN OTC DRUG Allergy Antihistamine Diphenhydramine HCl TABLET ORAL 20100722 OTC MONOGRAPH FINAL part336 SuperValu (Equaline) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41163-691_463ff541-98da-44d0-b5f9-d29e5a591cba 41163-691 HUMAN OTC DRUG Allergy Antihistamine Diphenhydramine HCl TABLET ORAL 20100722 OTC MONOGRAPH FINAL part336 EQUALINE (SuperValu) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41163-692_628cd685-d190-4937-9fd4-224621ef8860 41163-692 HUMAN OTC DRUG Equaline cool heat Menthol, Methyl salicylate CREAM TOPICAL 20100330 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g 41163-693_05b1aefc-98d9-4420-ab5c-a34cfa372b20 41163-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20041209 OTC MONOGRAPH NOT FINAL part334 Supervalu, Inc MAGNESIUM CITRATE 1.745 g/29.6mL 41163-701_68c1c19e-a3f3-4a33-82ef-1fc68414b07b 41163-701 HUMAN OTC DRUG Equaline Tussin Mucus and Chest Congestion Guaifenesin SYRUP ORAL 20131006 OTC MONOGRAPH FINAL part341 Supervalu Inc GUAIFENESIN 200 mg/10mL 41163-707_89c02e55-fa08-4001-96fc-8a01e7e74d5a 41163-707 HUMAN OTC DRUG equaline naproxen sodium Naproxen Sodium TABLET ORAL 20140924 ANDA ANDA074661 Supervalu Inc NAPROXEN SODIUM 220 mg/1 41163-728_f0f547dd-892b-4f94-8c63-7f0b2470aa91 41163-728 HUMAN OTC DRUG Equaline Fast Acting Phenylephrine hydrochloride SPRAY NASAL 20141030 OTC MONOGRAPH FINAL part341 SUPERVALU INC. PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL 41163-742_2f9a74ff-2398-40f9-851d-d2c6272ce1a8 41163-742 HUMAN OTC DRUG Equaline Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20101123 NDA NDA021920 Supervalu Inc NAPROXEN SODIUM 220 mg/1 41163-751_3d857877-2084-485c-85ae-b0f55363649e 41163-751 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN 500 mg/1 41163-759_cd15e15a-b916-4fd8-b6ed-3e19b8981347 41163-759 HUMAN OTC DRUG equaline pain relief Acetaminophen SUSPENSION ORAL 20100827 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-763_4e0c6ad6-81ef-4b0e-b2eb-44256faf7358 41163-763 HUMAN OTC DRUG equaline nighttime severe cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20140731 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 41163-770_f1770b67-548b-42b0-9a3a-f16c1995b330 41163-770 HUMAN OTC DRUG Equaline Muscle Rub Menthol, Methyl salicylate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g 41163-798_17dd5940-fb30-4a59-8f60-b4a5677065b5 41163-798 HUMAN OTC DRUG Equaline hair regrowth treatment for men Minoxidil SOLUTION TOPICAL 20091204 ANDA ANDA075598 Supervalu Inc MINOXIDIL 3 g/60mL 41163-799_d1518a7e-4eb0-495d-8fa1-3ad9ed3e74e2 41163-799 HUMAN OTC DRUG Equaline tussin cough and chest congestion dm max Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20100727 OTC MONOGRAPH FINAL part341 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 41163-801_eba8423c-0dab-4572-ade4-6964c1b4e676 41163-801 HUMAN OTC DRUG Clean and Refreshing Body Wash Spring Fresh Triclosan SOAP TOPICAL 20100922 OTC MONOGRAPH NOT FINAL part333E Supervalu Inc. TRICLOSAN .15 mL/100mL 41163-804_6ecf9c89-88c2-466c-be40-a85666034641 41163-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20050701 OTC MONOGRAPH NOT FINAL part333A Supervalue, Inc ISOPROPYL ALCOHOL .91 mg/mL 41163-806_2006eed4-7648-45d7-9d71-b6e40e5e2246 41163-806 HUMAN OTC DRUG equaline childrens acetaminophen Acetaminophen SUSPENSION ORAL 20141013 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-807_3f47f7d2-1e38-437e-9e28-30238fe7da26 41163-807 HUMAN OTC DRUG equaline zinc cold remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20090811 UNAPPROVED HOMEOPATHIC Supervalu Inc ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 41163-809_9bc05d1b-ae11-4a11-a20d-2c72c81e0646 41163-809 HUMAN OTC DRUG equaline antibiotic plus pain relief Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20120420 OTC MONOGRAPH FINAL part333B Supervalu Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 41163-810_6459afb3-3a44-4d17-96fe-1cd9cce558f4 41163-810 HUMAN OTC DRUG Sinus and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20111207 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 41163-811_1592fac0-72c9-4764-9e5c-7ffebe36b23d 41163-811 HUMAN OTC DRUG Equaline Cold and Hot Medicated Large Menthol PATCH TOPICAL 20100705 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc. MENTHOL 50 mg/1 41163-812_1592fac0-72c9-4764-9e5c-7ffebe36b23d 41163-812 HUMAN OTC DRUG Equaline Cold and Hot Medicated Small Menthol PATCH TOPICAL 20100705 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc. MENTHOL 50 mg/1 41163-816_be15441f-0dfa-455e-a45d-b55956da9cc2 41163-816 HUMAN OTC DRUG Alcohol Isopropyl Alcohol SWAB TOPICAL 20110406 OTC MONOGRAPH NOT FINAL part333A SuperValu, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 41163-822_0c5ce27e-4b3d-4de0-bda5-d8170a94b2b0 41163-822 HUMAN OTC DRUG Witch Hazel Witch Hazel SOLUTION TOPICAL 20090529 OTC MONOGRAPH FINAL part347 Supervalu, Inc WITCH HAZEL 979 mg/mL 41163-825_7ebd51d9-8578-48c8-804a-e80fbe514fa1 41163-825 HUMAN OTC DRUG Equaline Miconazole 7 Miconazole nitrate CREAM VAGINAL 20041110 ANDA ANDA074760 Supervalu Inc MICONAZOLE NITRATE 2 g/100g 41163-828_d2d024e7-1cd8-4237-b45d-bee97853ec0f 41163-828 HUMAN OTC DRUG EQUALINE SALICYLIC ACID PASTE TOPICAL 20130717 OTC MONOGRAPH FINAL part333D SUPERVALU INC. SALICYLIC ACID 20 mg/mL 41163-831_1935c9b2-62b9-4cf2-8d56-f14923f9c902 41163-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 20041222 OTC MONOGRAPH NOT FINAL part334 Supervalu, Inc MINERAL OIL 999 mg/mL 41163-837_2b87a038-fc76-4af5-94b6-39ee730f011b 41163-837 HUMAN OTC DRUG equaline pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20041022 OTC MONOGRAPH FINAL part338 Supervalu Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41163-843_558f17c9-80fd-4681-8a0a-d33e3f980b37 41163-843 HUMAN OTC DRUG Equaline hemorrhoidal cooling Phenylephrine HCl, Witch hazel GEL TOPICAL 20090115 OTC MONOGRAPH FINAL part346 Supervalu Inc PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/100g; g/100g 41163-845_1fac281e-fc82-4de5-996a-99ee6984aa5c 41163-845 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20050729 OTC MONOGRAPH FINAL part344 Supervalu Inc ISOPROPYL ALCOHOL 613 mg/mL 41163-851_49aed137-2700-4f2d-9a8f-2d9dd4a169e7 41163-851 HUMAN OTC DRUG equaline antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20041022 OTC MONOGRAPH FINAL part332 Supervalu Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 41163-854_e37b38ec-b7a9-4f85-80ec-154065b7fdb6 41163-854 HUMAN OTC DRUG Equaline Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20080923 ANDA ANDA078546 Supervalu Inc NICOTINE 4 mg/1 41163-856_19a177a8-64ac-4748-a1e8-d9d416a6e9f8 41163-856 HUMAN OTC DRUG equaline hair regrowth treatment for women Minoxidil SOLUTION TOPICAL 20070311 ANDA ANDA075357 Supervalu Inc MINOXIDIL 2 g/100mL 41163-866_d0e0468b-7824-4edc-b894-2673f2bd193f 41163-866 HUMAN OTC DRUG equaline lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070709 OTC MONOGRAPH FINAL part358G Supervalu Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL 41163-871_4e94fa12-2442-4e09-8793-85e402d0a6b3 41163-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20050114 OTC MONOGRAPH NOT FINAL part333A Supervalu, Inc HYDROGEN PEROXIDE .3 kg/100L 41163-872_afa1fae6-8883-4842-8560-de55c2c4db61 41163-872 HUMAN OTC DRUG Equaline nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20120717 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 41163-873_ac679c2d-5d06-4c48-b582-bdbdcbb3bdb5 41163-873 HUMAN OTC DRUG Equaline nicotine Nicotine Polacrilex LOZENGE ORAL 20060328 ANDA ANDA077007 Supervalu Inc NICOTINE 4 mg/1 41163-876_e8675d6d-442e-4ece-bea5-db2052e6458d 41163-876 HUMAN OTC DRUG Rubbing Ethyl Alcohol LIQUID TOPICAL 20050803 OTC MONOGRAPH NOT FINAL part333A Supervalu, Inc ALCOHOL 610 mg/mL 41163-882_0431fc8b-8916-41ba-b9d2-af98ff1ef741 41163-882 HUMAN OTC DRUG equaline gas relief infants Simethicone EMULSION ORAL 20041023 OTC MONOGRAPH FINAL part332 Supervalu Inc DIMETHICONE 20 mg/.3mL 41163-884_df74e37b-e460-4242-ad21-7dc75d0c7a94 41163-884 HUMAN OTC DRUG equaline all day allergy cetirizine Hydrochloride SOLUTION ORAL 20110726 ANDA ANDA090254 Supervalu Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 41163-888_1c9dc56c-deca-4468-8fe4-6258af61c37d 41163-888 HUMAN OTC DRUG equaline acetaminophen infants Acetaminophen SUSPENSION ORAL 20141212 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-897_70e3cf54-ee8c-4fc2-adee-a542aeb48ef0 41163-897 HUMAN OTC DRUG equaline ibuprofen childrens Ibuprofen SUSPENSION ORAL 20040830 ANDA ANDA074937 Supervalu Inc IBUPROFEN 100 mg/5mL 41163-902_41720842-fc89-4435-86fc-1e91f6f89bd6 41163-902 HUMAN OTC DRUG Day Time Cold Head Congestion Severe Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED ORAL 20050804 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 41163-903_ee8d3f61-66e2-4c42-ba7d-5cce9145471d 41163-903 HUMAN OTC DRUG equaline childrens cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20120829 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 41163-911_0f7f9ba4-18e4-4b8f-b168-187f0d160b67 41163-911 HUMAN OTC DRUG equaline childrens ibuprofen oral suspension Ibuprofen SUSPENSION ORAL 20040924 ANDA ANDA074937 Supervalu Inc IBUPROFEN 100 mg/5mL 41163-913_ba3cdef3-1b3c-4418-98b1-87d784e7a7aa 41163-913 HUMAN OTC DRUG equaline night time cold and cough childrens Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20110714 OTC MONOGRAPH FINAL part341 Supervalu Inc DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 41163-915_32fe0f04-dce2-4c11-87fb-f123a5993823 41163-915 HUMAN OTC DRUG equaline omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080222 NDA NDA022032 Supervalu Inc OMEPRAZOLE 20 mg/1 41163-916_69a1be15-22c6-4cd9-995b-15564906d568 41163-916 HUMAN OTC DRUG equaline miconazole 1 Miconazole nitrate KIT 20100611 ANDA ANDA079114 Supervalu Inc 41163-917_c6e3179c-013a-421c-9ec1-9859ea1382f5 41163-917 HUMAN OTC DRUG equaline pain relief extra strength Acetaminophen CAPSULE, COATED ORAL 20110131 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 500 mg/1 41163-922_2fe04f53-66f4-4d46-8292-53f0eb9e6667 41163-922 HUMAN OTC DRUG Equaline Mucus Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20131212 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 41163-923_1ea0a7ef-229f-4ff4-833e-2d966a4412f0 41163-923 HUMAN OTC DRUG equaline eye itch relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20101015 ANDA ANDA077958 Supervalu Inc KETOTIFEN FUMARATE .25 mg/mL 41163-944_548047c5-5a22-4350-acff-c2728ba1f310 41163-944 HUMAN OTC DRUG Equaline Hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20080328 OTC MONOGRAPH FINAL part346 Supervalu Inc GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g 41163-945_4572d6bd-df8a-4214-a095-e1ffb81ba5df 41163-945 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET ORAL 20140725 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ASPIRIN 81 mg/1 41163-946_424f141a-16c0-4143-a2e4-3fc9a84c3362 41163-946 HUMAN OTC DRUG equaline infants pain and fever Acetaminophen SUSPENSION ORAL 20121001 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-949_93321bf0-d58d-4ac1-bfa7-cb033ca9df85 41163-949 HUMAN OTC DRUG equaline milk of magnesia Magnesium hydroxide LIQUID ORAL 20051114 OTC MONOGRAPH NOT FINAL part334 Supervalu Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 41163-950_d20faf7d-fa24-4a8a-ac7b-d5910c70387b 41163-950 HUMAN OTC DRUG equaline heartburn relief Ranitidine TABLET, FILM COATED ORAL 20120725 ANDA ANDA091429 Supervalu Inc RANITIDINE HYDROCHLORIDE 150 mg/1 41163-955_a8d4eb78-4556-4315-815c-7f05e691b7aa 41163-955 HUMAN OTC DRUG equaline lice treatment Permethrin LOTION TOPICAL 20110128 ANDA ANDA076090 Supervalu Inc PERMETHRIN 1 mg/100mL 41163-958_2bdd9cf7-bb56-4fd2-9bb1-c8b7680b22df 41163-958 HUMAN OTC DRUG Equaline Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130715 ANDA ANDA091135 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 41163-959_b3797427-60a4-4f38-8044-133d5f4664f6 41163-959 HUMAN OTC DRUG equaline childrens pain and fever Acetaminophen SUSPENSION ORAL 20120206 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41163-964_10a53233-c49b-469d-9d2c-98b813924b5b 41163-964 HUMAN OTC DRUG equaline flu and severe cold and cough Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20110726 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 41163-970_7f67c411-be95-4848-bf29-87ccbd1a8781 41163-970 HUMAN OTC DRUG Allergy relief Diphenhydramine HCl CAPSULE ORAL 20110815 OTC MONOGRAPH FINAL part336 SuperValu (Equaline) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41163-973_d1ac686e-62f2-4177-8abc-8c7ca578de1a 41163-973 HUMAN OTC DRUG equaline anti itch maximum strength hydrocortisone CREAM TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc HYDROCORTISONE 1 g/100g 41163-974_0a169e70-a0c5-4645-a0a9-b5724e74152d 41163-974 HUMAN OTC DRUG Equaline childrens all day allergy cetirizine hydrochloride SOLUTION ORAL 20080520 ANDA ANDA090254 Supervalu Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 41163-977_6845d898-8e6f-4779-9a2f-af80c0419f95 41163-977 HUMAN OTC DRUG equaline nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20060712 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 41163-980_4dc2b359-8d96-4769-b84a-a4fe82d68973 41163-980 HUMAN OTC DRUG Equaline pain relief concentrated Acetaminophen SUSPENSION/ DROPS ORAL 20100827 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 80 mg/.8mL 41163-987_c45f4455-a48c-4172-b7e7-95a5341ee2e9 41163-987 HUMAN OTC DRUG equaline childrens cold and cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20120727 OTC MONOGRAPH FINAL part341 Supervalu Inc BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 41163-990_932cb41b-67f4-49ac-a0ef-453158ee41af 41163-990 HUMAN OTC DRUG equaline nighttime acetaminophen, dextromethorphan hydrobromide, doxylamine succinate LIQUID ORAL 20110804 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 41163-994_c308e7a9-b95d-440c-a3ee-d44810f2d6fc 41163-994 HUMAN OTC DRUG equaline daytime cold and flu relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20120727 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 41163-997_d1208740-6d8a-4c56-a50b-043ce62f0553 41163-997 HUMAN OTC DRUG equaline childrens acetaminophen Acetaminophen SUSPENSION ORAL 20141015 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL 41167-0014_dc50f666-7eba-4545-8840-2cbb209acfb8 41167-0014 HUMAN OTC DRUG Unisom SleepMelts Diphenhydramine Hydrochloride TABLET, CHEWABLE ORAL 20080101 OTC MONOGRAPH FINAL part338 Chattem, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41167-0031_a3e167e1-5e04-4f4c-bc82-497421209d89 41167-0031 HUMAN OTC DRUG Cortizone 10 Cooling Cream Anti-Itch Hydrocortisone CREAM TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 1 g/100g 41167-0032_af4980c7-c462-4594-a12b-eacb79c96b75 41167-0032 HUMAN OTC DRUG Cortizone 10 Easy Relief Hydrocortisone LIQUID TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 10 mg/mL 41167-0035_ab14d0a9-7796-48f5-8c2c-5d2531807b2d 41167-0035 HUMAN OTC DRUG Cortizone 10 Intensive Healing hydrocortisone CREAM TOPICAL 20071201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 10 mg/g 41167-0036_ab14d0a9-7796-48f5-8c2c-5d2531807b2d 41167-0036 HUMAN OTC DRUG Cortizone 10 Cooling Relief Hydrocortisone GEL TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 10 mg/g 41167-0039_ab14d0a9-7796-48f5-8c2c-5d2531807b2d 41167-0039 HUMAN OTC DRUG Cortizone 10 hydrocortisone CREAM TOPICAL 20070901 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 10 mg/g 41167-0040_2752fd74-773f-4852-ae8e-08169a293575 41167-0040 HUMAN OTC DRUG Unisom PM Pain Nighttime Sleep Aid and Pain Reliever Acetaminophen and Diphenhydramine Hydrochloride TABLET ORAL 20091201 OTC MONOGRAPH FINAL part338 Chattem, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 325; 50 mg/1; mg/1 41167-0053_e3928572-063c-4087-8b9f-2c5752b36793 41167-0053 HUMAN OTC DRUG Benzodent Benzocaine CREAM TOPICAL 19940512 OTC MONOGRAPH NOT FINAL part356 Chattem, Inc. BENZOCAINE .2 g/g 41167-0060_5fe00f5f-4208-4682-9ef0-7b5fd865a0e6 41167-0060 HUMAN OTC DRUG Unisom SleepTabs Doxylamine Succinate TABLET ORAL 19781018 NDA NDA018066 Chattem, Inc. DOXYLAMINE SUCCINATE 25 mg/1 41167-0061_32c9114a-dbce-477e-9795-d21c722a5fa0 41167-0061 HUMAN OTC DRUG Unisom SleepGels Nighttime Sleep-Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20070101 OTC MONOGRAPH FINAL part338 Chattem, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 41167-0066_a587f165-9a90-4a5d-9070-65f2d70e8a5a 41167-0066 HUMAN OTC DRUG Unisom Warming Cherry Diphenhydramine Hydrochloride LIQUID ORAL 20131202 OTC MONOGRAPH FINAL part338 Chattem, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 41167-0073_772ddb13-0980-44b7-ab81-c1b3e302bf98 41167-0073 HUMAN OTC DRUG Icy Hot Back and Large Areas Menthol PATCH TOPICAL 20030301 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 428.5 mg/1 41167-0075_8b2d0a6b-7089-48d2-a477-2bfbd8e00e09 41167-0075 HUMAN OTC DRUG Selsun Blue Accion Humetante Selenium Sulfide SHAMPOO TOPICAL 20121201 OTC MONOGRAPH FINAL part358H Chattem, Inc. SELENIUM SULFIDE 1 g/100mL 41167-0076_8b2d0a6b-7089-48d2-a477-2bfbd8e00e09 41167-0076 HUMAN OTC DRUG Selsun Azul Suave y Manejable Humectante Selenium Sulfide SHAMPOO TOPICAL 20121201 OTC MONOGRAPH FINAL part358H Chattem, Inc. SELENIUM SULFIDE 1 g/100mL 41167-0077_a4ec518e-dbed-4094-a8f8-912fa8a6fa2c 41167-0077 HUMAN OTC DRUG Selsun Oro Selenium Sulfide SHAMPOO TOPICAL 19520801 NDA NDA007936 Chattem, Inc. SELENIUM SULFIDE .025 g/mL 41167-0083_772ddb13-0980-44b7-ab81-c1b3e302bf98 41167-0083 HUMAN OTC DRUG Icy Hot Back and Large Areas Menthol PATCH TOPICAL 20030301 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 428.5 mg/1 41167-0084_772ddb13-0980-44b7-ab81-c1b3e302bf98 41167-0084 HUMAN OTC DRUG Icy Hot Arm Neck Leg and Small Areas Menthol PATCH TOPICAL 20001101 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 205.5 mg/1 41167-0085_a1960664-96aa-4c4d-b0e0-7ff1d175c702 41167-0085 HUMAN OTC DRUG Icy Hot Arthritis Camphor and Menthol LOTION TOPICAL 20111117 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. CAMPHOR (SYNTHETIC); MENTHOL 4; 16 g/100g; g/100g 41167-0086_65d644ce-7f1a-4b94-b06e-ddfa0322c044 41167-0086 HUMAN OTC DRUG Icy Hot Power Gel Menthol GEL TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL .16 g/g 41167-0087_bb41ab75-a2c0-4a26-a056-4de05e67e45c 41167-0087 HUMAN OTC DRUG Icy Hot Menthol and Methyl Salicylate OINTMENT TOPICAL 19910601 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL; METHYL SALICYLATE 7.6; 29 g/100g; g/100g 41167-0088_bb41ab75-a2c0-4a26-a056-4de05e67e45c 41167-0088 HUMAN OTC DRUG Icy Hot Menthol and Methyl Salicylate CREAM TOPICAL 19910601 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g 41167-0089_bb41ab75-a2c0-4a26-a056-4de05e67e45c 41167-0089 HUMAN OTC DRUG Icy Hot Menthol and Methyl Salicylate STICK TOPICAL 19910601 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g 41167-0091_0b074b34-9242-4749-ab86-2b870d85a25e 41167-0091 HUMAN OTC DRUG Icy Hot Medicated No Mess Applicator Menthol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL .16 g/mL 41167-0092_43577360-19d7-4fd9-8218-c634fc14dab3 41167-0092 HUMAN OTC DRUG Icy Hot Vanishing Scent Menthol GEL TOPICAL 20070301 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL .025 g/g 41167-0093_8e133e04-6a3a-4737-a71c-9bc5c35a0dea 41167-0093 HUMAN OTC DRUG Icy Hot Naturals Menthol CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL .075 g/g 41167-0094_2a51da3b-d81c-4d30-b3d5-6f00932d3b8b 41167-0094 HUMAN OTC DRUG Icy Hot No Mess Vapor Cough Suppresant Camphor and Eucalyptus oil and Menthol GEL TOPICAL 20100610 OTC MONOGRAPH FINAL part341 Chattem, Inc. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 5.3; 1.3; 2.8 g/100g; g/100g; g/100g 41167-0095_cb4e43da-c3f6-4525-a274-d8a1d4700ebe 41167-0095 HUMAN OTC DRUG ICYHOT Medicated Menthol SPRAY TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 160 mg/mL 41167-0096_41ec4c4c-d4dc-4b53-a972-38d4508e2ef7 41167-0096 HUMAN OTC DRUG Icy Hot No Mess Vapor Cough Suppresant for Kids Camphor and Eucalyptus oil and Menthol GEL TOPICAL 20100610 OTC MONOGRAPH FINAL part341 Chattem, Inc. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.7; 1.2; 2.6 g/100g; g/100g; g/100g 41167-0100_21a9b913-b0b2-48c8-99c6-c98ad7f8ed08 41167-0100 HUMAN OTC DRUG Maximum Strength Cortizone 10 Quick Shot 360 Continuous Hydrocortisone SPRAY TOPICAL 20121206 OTC MONOGRAPH FINAL part348 Chattem, Inc. HYDROCORTISONE 10 mg/mL 41167-0104_dffda314-fc8b-4617-b302-caffe1bb3316 41167-0104 HUMAN OTC DRUG Gold Bond Original Strength Menthol and Zinc Oxide POWDER TOPICAL 19960429 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL; ZINC OXIDE .0015; .01 g/g; g/g 41167-0105_ab14d0a9-7796-48f5-8c2c-5d2531807b2d 41167-0105 HUMAN OTC DRUG Cortizone 10 Plus Hydrocortisone CREAM TOPICAL 20070901 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 10 mg/g 41167-0170_8708f79b-93fd-44e8-8028-22a36e192197 41167-0170 HUMAN OTC DRUG Gold Bond Foot Extra Strength menthol POWDER TOPICAL 19960429 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 1 g/100g 41167-0172_41d2c45c-1076-4bbf-9b8f-11b5b478aef3 41167-0172 HUMAN OTC DRUG Gold Bond Medicated Foot Menthol SPRAY TOPICAL 20011201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 1 g/100g 41167-0174_ce94c66b-92a9-4a14-bb78-4530124b591a 41167-0174 HUMAN OTC DRUG Gold Bond Pain Relieving Foot Menthol CREAM TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 16 g/100g 41167-0176_7a47f297-5c31-4c00-99d5-9cd98fe94424 41167-0176 HUMAN OTC DRUG Gold Bond Pain Relieving Foot Roll On Menthol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL .16 g/mL 41167-0230_e35989c4-d381-47f8-a44a-6aa3b78a38a2 41167-0230 HUMAN OTC DRUG Gold Bond Baby Cornstarch Plus cornstarch and kaolin and zinc oxide POWDER TOPICAL 19960429 OTC MONOGRAPH FINAL part347 Chattem, Inc. KAOLIN; STARCH, CORN; ZINC OXIDE .04; .79; .15 g/g; g/g; g/g 41167-0242_f7ace378-6465-4dc5-bb00-09ae02038c8e 41167-0242 HUMAN OTC DRUG Balmex Diaper Rash Zinc Oxide CREAM TOPICAL 20081215 OTC MONOGRAPH FINAL part347 Chattem, Inc. ZINC OXIDE .113 g/g 41167-0243_f7ace378-6465-4dc5-bb00-09ae02038c8e 41167-0243 HUMAN OTC DRUG Balmex Diaper Rash Stick Zinc Oxide CREAM TOPICAL 20081215 OTC MONOGRAPH FINAL part347 Chattem, Inc. ZINC OXIDE .113 g/g 41167-0244_8d106872-a8ab-4419-a9d7-4dd5b4dc6ec7 41167-0244 HUMAN OTC DRUG Balmex Adult Care Rash Zinc Oxide CREAM TOPICAL 20121201 OTC MONOGRAPH FINAL part347 Chattem, Inc. ZINC OXIDE .113 g/g 41167-0262_0adda557-42cc-4216-992f-808b395db403 41167-0262 HUMAN OTC DRUG Balmex Multi Purpose Healing Petrolatum OINTMENT TOPICAL 20081201 OTC MONOGRAPH FINAL part347 Chattem, Inc. PETROLATUM .511 g/g 41167-0331_c1b50ddb-bad9-4148-a5de-04a8e9bd12fe 41167-0331 HUMAN OTC DRUG Cortizone 10 Intensive Healing for Eczema Hydrocortisone LOTION TOPICAL 20091208 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 10 mg/g 41167-0332_fbe41414-2362-4d33-b1e6-f17717ed4947 41167-0332 HUMAN OTC DRUG Cortizone 10 Poison Ivy Relief Pads Hydrocortisone GEL TOPICAL 20130120 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 1 g/100g 41167-0333_bec3a8e3-3dfd-4bcd-ab47-5e08fce586f0 41167-0333 HUMAN OTC DRUG Cortizone 10 Hydratensive Soothing Anti Itch Hydrocortisone LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 1 g/100g 41167-0334_81dbbcce-9383-4ac2-af9e-be0f545bd8b7 41167-0334 HUMAN OTC DRUG Cortizone 10 Hydratensive Healing Anti Itch Hydrocortisone LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 1 g/100g 41167-0339_ab14d0a9-7796-48f5-8c2c-5d2531807b2d 41167-0339 HUMAN OTC DRUG Cortizone 10 Hydrocortisone OINTMENT TOPICAL 20070901 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 10 mg/g 41167-0404_dffda314-fc8b-4617-b302-caffe1bb3316 41167-0404 HUMAN OTC DRUG Gold Bond Extra Strength Menthol and Zinc Oxide POWDER TOPICAL 19960429 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL; ZINC OXIDE .008; .05 g/g; g/g 41167-0470_6c263ca4-1049-44c7-99b8-4f20554ad6f9 41167-0470 HUMAN OTC DRUG Gold Bond Ultimate Hand Sanitizer Sheer Moisture Benzethonium chloride LOTION TOPICAL 20091115 OTC MONOGRAPH NOT FINAL part333 Chattem, Inc. BENZETHONIUM CHLORIDE .2 g/100g 41167-0501_ee09af98-ef35-44f1-9291-3163a44df677 41167-0501 HUMAN OTC DRUG Gold Bond Anti Itch Menthol and Pramoxine Hydrochloride CREAM TOPICAL 19960401 OTC MONOGRAPH FINAL part347 Chattem, Inc. MENTHOL; PRAMOXINE HYDROCHLORIDE .01; .01 g/g; g/g 41167-0506_8f11d5ea-ab9b-4270-8d41-742598f6f6b6 41167-0506 HUMAN OTC DRUG Gold Bond Anti Itch Menthol, Pramoxine HCl, and Dimethicone LOTION TOPICAL 20081201 OTC MONOGRAPH FINAL part347 Chattem, Inc. DIMETHICONE; MENTHOL; PRAMOXINE HYDROCHLORIDE .05; .005; .01 g/g; g/g; g/g 41167-0510_f201035d-335b-4fab-a5e8-fc30d1e96983 41167-0510 HUMAN OTC DRUG Gold Bond Intensive Healing Anti Itch Skin Protectant Dimethicone and Pramoxine Hydrochloride CREAM TOPICAL 20090115 OTC MONOGRAPH FINAL part347 Chattem, Inc. DIMETHICONE; PRAMOXINE HYDROCHLORIDE .06; .01 g/g; g/g 41167-0540_f906af19-d3dc-45ba-983e-65d7d23b5eda 41167-0540 HUMAN OTC DRUG Gold Bond Ultimate Diabetics Dimethicone and White Petrolatum CREAM TOPICAL 19980203 OTC MONOGRAPH FINAL part347 Chattem, Inc. DIMETHICONE; PETROLATUM .03; .3 g/g; g/g 41167-0574_f7cef50a-cac8-410b-9698-b3ab125d20a3 41167-0574 HUMAN OTC DRUG Aspercreme Heat Menthol GEL TOPICAL 19981201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 10 g/100mL 41167-0575_e819ae7f-2f20-46bd-b7a4-b4f5a57a77f9 41167-0575 HUMAN OTC DRUG Aspercreme Max No Mess Roll On Menthol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL .16 g/mL 41167-0582_2474b240-7f2d-440c-ae01-c92a47a4525c 41167-0582 HUMAN OTC DRUG Aspercreme with Lidocaine Pain Relieving Creme Lidocaine Hydrochloride LOTION TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. LIDOCAINE HYDROCHLORIDE 4 g/100g 41167-0600_69f5ec58-24d6-42fd-b468-6114d14807e0 41167-0600 HUMAN OTC DRUG Arthritis Hot Menthol and Methyl Salicylate CREAM TOPICAL 19981201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g 41167-0610_60aefd90-cda0-441f-9d0f-3bd3ee4e3dd4 41167-0610 HUMAN OTC DRUG Gold Bond Original Strength Dimethicone and Menthol LOTION TOPICAL 19980203 OTC MONOGRAPH FINAL part347 Chattem, Inc. DIMETHICONE; MENTHOL .05; .0015 g/g; g/g 41167-0625_f0d04dc1-72a2-4cf1-9434-b45520283e1c 41167-0625 HUMAN OTC DRUG Gold Bond Ultimate Protection Avobenzone and Homosalate and Octisalate and Octocrylene LOTION TOPICAL 20080301 OTC MONOGRAPH NOT FINAL part352 Chattem, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 4; 2 g/100g; g/100g; g/100g; g/100g 41167-0640_60aefd90-cda0-441f-9d0f-3bd3ee4e3dd4 41167-0640 HUMAN OTC DRUG Gold Bond Extra Strength Dimethicone and Menthol LOTION TOPICAL 19980203 OTC MONOGRAPH FINAL part347 Chattem, Inc. DIMETHICONE; MENTHOL .05; .005 g/g; g/g 41167-0662_758acc70-4cab-46dd-bfb4-cccf84999763 41167-0662 HUMAN OTC DRUG Gold Bond Ultimate Eczema Relief Colloidal oatmeal CREAM TOPICAL 20131006 OTC MONOGRAPH FINAL part347 Chattem, Inc. OATMEAL 20 mg/g 41167-0673_785d26b7-7c34-41f4-b4d5-917b6dccf324 41167-0673 HUMAN OTC DRUG Gold Bond Ultimate Healing Concentrated Therapy Cream Dimethicone Petrolatum CREAM TOPICAL 20090701 OTC MONOGRAPH FINAL part347 Chattem, Inc. DIMETHICONE; PETROLATUM .03; .3 g/g; g/g 41167-0675_48c502b6-b845-488e-94f8-e07507aa7180 41167-0675 HUMAN OTC DRUG Gold Bond Ultimate Healing Concentrated Therapy White Petrolatum OINTMENT TOPICAL 20090701 OTC MONOGRAPH FINAL part347 Chattem, Inc. PETROLATUM 450 mg/mL 41167-0773_ea7efced-b9d3-4857-ab48-6bb47e9a4b2a 41167-0773 HUMAN OTC DRUG Gold Bond Ultimate Hand Sanitizer Moisturizer Benzethonium Chloride LOTION TOPICAL 20091115 OTC MONOGRAPH NOT FINAL part333 Chattem, Inc. BENZETHONIUM CHLORIDE .2 g/100g 41167-0801_5f4db1da-f3e6-4524-a713-1332e629508d 41167-0801 HUMAN OTC DRUG Icy Hot Advanced Relief Camphor and Menthol CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. CAMPHOR (SYNTHETIC); MENTHOL .11; .16 g/g; g/g 41167-0805_ad7b463f-93d8-41b6-b251-a9d322a45f67 41167-0805 HUMAN OTC DRUG Icy Hot Advanced Relief Menthol Topical Analgesic PATCH TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 210 mg/1 41167-0830_0209cb51-b8f2-4c06-8b69-0235f496d7df 41167-0830 HUMAN OTC DRUG Icy Hot Menthol PATCH TOPICAL 20040201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 336 mg/1 41167-0843_772ddb13-0980-44b7-ab81-c1b3e302bf98 41167-0843 HUMAN OTC DRUG Icy Hot Back and Large Areas Menthol PATCH TOPICAL 20030301 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 428.5 mg/1 41167-0844_0209cb51-b8f2-4c06-8b69-0235f496d7df 41167-0844 HUMAN OTC DRUG Icy Hot Menthol PATCH TOPICAL 20040201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 336 mg/1 41167-0847_772ddb13-0980-44b7-ab81-c1b3e302bf98 41167-0847 HUMAN OTC DRUG Icy Hot XL Back and Large Areas Menthol PATCH TOPICAL 20071201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 750 mg/1 41167-0850_f38ec58a-d0e4-43db-bf46-aa248c69d430 41167-0850 HUMAN OTC DRUG Icy Hot Medicated Roll Medium Menthol PATCH TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 787.5 mg/1 41167-0851_f38ec58a-d0e4-43db-bf46-aa248c69d430 41167-0851 HUMAN OTC DRUG Icy Hot Medicated Roll Large Menthol PATCH TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 866.25 mg/1 41167-0934_aa9673b7-f427-48e9-8beb-193ea0f7098e 41167-0934 HUMAN OTC DRUG ACT Anticavity Fluoride Rinse Kids Scooby Doo sodium fluoride RINSE TOPICAL 20121201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .5 mg/mL 41167-0935_721bc788-7b43-4666-8885-83ef01740f45 41167-0935 HUMAN OTC DRUG ACT Anticavity Fluoride Kids Spongebob Sodium fluoride RINSE TOPICAL 20100201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL 41167-0936_df50b823-f699-4ce1-9af5-74637dfd7327 41167-0936 HUMAN OTC DRUG ACT Anticavity Kids iCarly Fluoride sodium fluoride RINSE TOPICAL 20110201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .5 mg/mL 41167-0940_3d17225d-5718-447c-8976-2ae169822f5e 41167-0940 HUMAN OTC DRUG ACT Anticavity Fluoride Cinnamon Sodium fluoride RINSE TOPICAL 19940401 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL 41167-0942_45220b6d-b403-4126-af9b-64f1034dac0a 41167-0942 HUMAN OTC DRUG ACT Anticavity Fluoride Mint Sodium Fluoride RINSE TOPICAL 19940401 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL 41167-0943_045925b8-cc86-4793-95ea-1410cbb7cdc2 41167-0943 HUMAN OTC DRUG Act Total Care Anticavity Fluoride Fresh Mint sodium fluoride RINSE TOPICAL 20120101 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .09 mg/mL 41167-0944_82b64d78-c532-4621-8e9b-ba7982f24218 41167-0944 HUMAN OTC DRUG ACT Anticavity Fluoride Kids Bubblegum Sodium fluoride RINSE TOPICAL 19930201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL 41167-0952_a61a970e-9f55-48af-955b-7dc9b460701f 41167-0952 HUMAN OTC DRUG ACT Braces Care Anticavity sodium fluoride MOUTHWASH ORAL 20140203 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .09 mg/mL 41167-0956_33dfc497-5e53-4b06-bb87-c39fbab736af 41167-0956 HUMAN OTC DRUG ACT Restoring Anticavity Fluoride Spearmint sodium fluoride MOUTHWASH TOPICAL 20060201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL 41167-0957_7ff06adb-23d6-4e42-8675-59daf384df5f 41167-0957 HUMAN OTC DRUG ACT Restoring Anticavity Fluoride Cool Mint sodium fluoride MOUTHWASH TOPICAL 20060201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL 41167-0961_10473d12-31e0-4ac0-9857-3f40c3c0fc75 41167-0961 HUMAN OTC DRUG ACT Total Care Anticavity Fluoride Fresh Mint sodium fluoride RINSE TOPICAL 20090201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL 41167-0962_2333c1dc-3b22-485b-a9a5-2e1c0f67fdad 41167-0962 HUMAN OTC DRUG ACT Anticavity Fluoride Mint sodium fluoride RINSE TOPICAL 20090201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .09 mg/mL 41167-0964_542fa480-0ac2-4554-ba2f-2144facf825a 41167-0964 HUMAN OTC DRUG ACT Total Care Sensitive Anticavity Mint Mouth Sodium Fluoride RINSE TOPICAL 20120101 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .09 mg/mL 41167-0965_5de31d5e-722a-41fb-be8b-ea77dbbd0a6a 41167-0965 HUMAN OTC DRUG ACT Total Care Anticavity Fluoride Icy Clean Mint sodium fluoride MOUTHWASH TOPICAL 20090201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL 41167-0966_62e32e24-78cd-402f-a1b2-77561dd3fd1d 41167-0966 HUMAN OTC DRUG ACT Total Care Anticavity Fluoride Icy Clean Mint sodium fluoride MOUTHWASH TOPICAL 20090201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .09 mg/mL 41167-0968_0fccb3d0-75f4-4ed8-8fee-bea9c90a9203 41167-0968 HUMAN OTC DRUG ACT Total Care Dry Mouth Anticavity Mouth Sodium Fluoride RINSE TOPICAL 20110201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .09 mg/mL 41167-0969_8eec5766-4815-4b4b-b2b6-e29562b3441f 41167-0969 HUMAN OTC DRUG ACT Total Care Sensitive Anticavity Tropical Mouth Sodium Fluoride RINSE TOPICAL 20120101 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .09 mg/mL 41167-0977_b7a87569-3497-4f0b-9e75-38ce740ad48d 41167-0977 HUMAN OTC DRUG ACT Restoring Anticavity Fluoride Cool Splash Vanilla Mint sodium fluoride MOUTHWASH TOPICAL 20060801 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .5 mg/mL 41167-0980_7023c87e-b16d-4aba-97d4-8e12b7829d07 41167-0980 HUMAN OTC DRUG ACT Restoring Anticavity Fluoride Mouthwash Cool Splash Spearmint 2X sodium fluoride MOUTHWASH TOPICAL 20060201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL 41167-0981_64c98bf5-6584-42a9-a4fe-9a7eb2eb45a3 41167-0981 HUMAN OTC DRUG ACT Restoring Anticavity Fluoride Cool Mint sodium fluoride MOUTHWASH TOPICAL 20060201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .09 mg/mL 41167-1000_63358a2d-c3c2-4cb2-9ab4-fd82aa1c3966 41167-1000 HUMAN OTC DRUG Rolaids Regular Strength Mint Calcium carbonate and Magnesium hydroxide TABLET, CHEWABLE ORAL 20130901 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 550; 110 mg/1; mg/1 41167-1001_d1488163-0abf-46b6-86e7-95ec594feb3d 41167-1001 HUMAN OTC DRUG Rolaids Extra Strength Mint Calcium carbonate and Magnesium hydroxide TABLET, CHEWABLE ORAL 20130901 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 675; 135 mg/1; mg/1 41167-1002_95a82c7c-6eb6-440f-8a8e-3beb2b1f19de 41167-1002 HUMAN OTC DRUG Rolaids Extra Strength Fruit Calcium carbonate and Magnesium hydroxide TABLET, CHEWABLE ORAL 20130901 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 675; 135 mg/1; mg/1 41167-1003_0855d225-454b-4347-923c-81f7851ad9ca 41167-1003 HUMAN OTC DRUG Rolaids Ultra Strength Mint Calcium carbonate and Magnesium hydroxide TABLET, CHEWABLE ORAL 20130901 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 1000; 200 mg/1; mg/1 41167-1004_082c8784-c8e0-4825-b955-bc2819c25600 41167-1004 HUMAN OTC DRUG Rolaids Ultra Strength Fruit Calcium carbonate and Magnesium hydroxide TABLET, CHEWABLE ORAL 20130901 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 1000; 200 mg/1; mg/1 41167-1005_d0c28b8c-cb67-4f50-afa7-e971a488a7b2 41167-1005 HUMAN OTC DRUG Rolaids Regular Strength- Mint Calcium carbonate and Magnesium hydroxide LIQUID ORAL 20130801 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 550; 110 mg/5mL; mg/5mL 41167-1006_d0c28b8c-cb67-4f50-afa7-e971a488a7b2 41167-1006 HUMAN OTC DRUG Rolaids Regular Strength- Cherry Calcium carbonate and Magnesium hydroxide LIQUID ORAL 20130801 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 550; 110 mg/5mL; mg/5mL 41167-1007_d0c28b8c-cb67-4f50-afa7-e971a488a7b2 41167-1007 HUMAN OTC DRUG Rolaids Ultra Strength- Mint Calcium carbonate and Magnesium hydroxide LIQUID ORAL 20130801 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 1000; 200 mg/5mL; mg/5mL 41167-1008_d0c28b8c-cb67-4f50-afa7-e971a488a7b2 41167-1008 HUMAN OTC DRUG Rolaids Ultra Strength- Cherry Calcium carbonate and Magnesium hydroxide LIQUID ORAL 20130801 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 1000; 200 mg/5mL; mg/5mL 41167-1214_549fdf39-cc3c-427d-b63c-dda4a6307b76 41167-1214 HUMAN OTC DRUG Capzasin P Arthritis Pain Relief Capsaicin CREAM TOPICAL 19981201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. CAPSAICIN .00035 g/g 41167-1601_35927d9b-7b4e-4f2c-8de3-22e5f0de06b0 41167-1601 HUMAN OTC DRUG Flexall Pain Relieving Menthol GEL TOPICAL 19970101 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL .07 g/g 41167-1602_f26fd3eb-77ed-4ed6-bb0d-9966272f084b 41167-1602 HUMAN OTC DRUG Flexall Pain Relieving Menthol GEL TOPICAL 19970101 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL .16 g/g 41167-1603_44b74ab1-6ab6-48c0-bd2e-4ae0c55c615d 41167-1603 HUMAN OTC DRUG Flexall Plus Menthol and Camphor and Methyl Salicylate GEL TOPICAL 19970101 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE .031; .16; .1 g/g; g/g; g/g 41167-1651_7ef78644-cfa9-42ff-bc9d-0a5b392b2195 41167-1651 HUMAN OTC DRUG Selsun Blue 2-in-1 Selenium Sulfide SHAMPOO TOPICAL 20020401 OTC MONOGRAPH FINAL part358H Chattem, Inc. SELENIUM SULFIDE 1 g/100mL 41167-3001_a8e0ac39-bab2-49b6-b40c-53e22d7b5c6f 41167-3001 HUMAN OTC DRUG Pamprin Multisymptom Menstrual Pain Relief Acetaminophen and Pamabrom and Pyrilamine Maleate TABLET ORAL 20100501 OTC MONOGRAPH NOT FINAL part343 Chattem, Inc. ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 41167-3002_49d2fc62-3003-4f54-9c6a-0792197772ed 41167-3002 HUMAN OTC DRUG Pamprin Cramp Menstrual Pain Relief Acetaminophen and Magnesium Salicylate and Pamabrom TABLET ORAL 19830101 OTC MONOGRAPH NOT FINAL part343 Chattem, Inc. ACETAMINOPHEN; MAGNESIUM SALICYLATE; PAMABROM 250; 250; 25 mg/1; mg/1; mg/1 41167-3006_23b38de1-059c-46f8-8941-700d5ebc0215 41167-3006 HUMAN OTC DRUG Pamprin Max Menstrual Pain Relief Acetaminophen and Aspirin and Caffeine TABLET ORAL 20060201 OTC MONOGRAPH NOT FINAL part343 Chattem, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 41167-3102_5aef7ded-428b-4a4f-9643-4b8c32767e9b 41167-3102 HUMAN OTC DRUG Premsyn pms Premenstrual Syndrome Relief Acetaminophen and Pamabrom and Pyrilamine maleate TABLET ORAL 20100501 OTC MONOGRAPH NOT FINAL part357 Chattem, Inc. ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 41167-3301_53e525b8-5faf-4139-bd4c-4b5f6ac808db 41167-3301 HUMAN OTC DRUG Bullfrog Surfer Octinoxate and Octocrylene and Oxybenzone GEL TOPICAL 19890101 OTC MONOGRAPH NOT FINAL part352 Chattem, Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE .075; .1; .03 g/mL; g/mL; g/mL 41167-3304_cec87115-add7-486b-9bc4-a1fc94e1b283 41167-3304 HUMAN OTC DRUG BullFrog Super Block Octinoxate and Octocrylene and Oxybenzone and Octisalate and Meradimate and Titantium Dioxide SPRAY TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part352 Chattem, Inc. MERADIMATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .05; .075; .05; .1; .06; .07 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL 41167-3305_db8b7692-b96c-45de-82cd-68747af05797 41167-3305 HUMAN OTC DRUG BullFrog Quik Avobenzone and Homosalate and Octisalate and Octocrylene and Oxybenzone GEL TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 Chattem, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .15; .05; .1; .06 g/mL; g/mL; g/mL; g/mL; g/mL 41167-3316_1712959a-0164-4fff-bf4e-7caf11da6ec8 41167-3316 HUMAN OTC DRUG BullFrog Ultimate Sheer Protection Face Avobenzone and Homosalate and Octisalate and Octocrylene LOTION TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 Chattem, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .03; .12; .05; .05 g/g; g/g; g/g; g/g 41167-3318_db8b7692-b96c-45de-82cd-68747af05797 41167-3318 HUMAN OTC DRUG BullFrog Quik Gel Sport Avobenzone and Homosalate and Octisalate and Octocrylene and Oxybenzone SPRAY TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 Chattem, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .15; .05; .1; .06 g/mL; g/mL; g/mL; g/mL; g/mL 41167-3325_82fdccec-47f0-4ce2-8bf6-cb77c083020a 41167-3325 HUMAN OTC DRUG BullFrog Water Armor Sport Super Octinoxate and Octocrylene and Oxybenzone and Octisalate and Meradimate and Titantium Dioxide LOTION TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part352 Chattem, Inc. MERADIMATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .05; .075; .05; .1; .06; .045 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL 41167-3330_460a653c-06f3-4de8-be91-1f64b3c22c83 41167-3330 HUMAN OTC DRUG Kaopectate Regular Strength Peppermint Flavor Anti Diarrheal bismuth subsalicylate LIQUID ORAL 20030401 OTC MONOGRAPH FINAL part335 Chattem, Inc. BISMUTH SUBSALICYLATE 17.47 mg/mL 41167-4000_656255be-4b4e-47a1-994d-2eab973ec998 41167-4000 HUMAN OTC DRUG Kaopectate Regular Strength Vanilla Flavor Anti Diarrheal bismuth subsalicylate LIQUID ORAL 20030401 OTC MONOGRAPH FINAL part335 Chattem, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL 41167-4002_8ee4dc5e-df8e-4c0d-8522-a648565ea366 41167-4002 HUMAN OTC DRUG Kaopectate Bismuth subsalicylate TABLET ORAL 20130401 OTC MONOGRAPH FINAL part335 Chattem, Inc. BISMUTH SUBSALICYLATE 262 mg/1 41167-4120_4a91d5c7-9c4d-4019-9045-ef07a53acc6a 41167-4120 HUMAN OTC DRUG Allegra Allergy fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110303 NDA NDA020872 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 41167-4121_4a91d5c7-9c4d-4019-9045-ef07a53acc6a 41167-4121 HUMAN OTC DRUG Allegra Allergy fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110303 NDA NDA020872 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 41167-4131_4a91d5c7-9c4d-4019-9045-ef07a53acc6a 41167-4131 HUMAN OTC DRUG Allegra Allergy fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110303 NDA NDA020872 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE 60 mg/1 41167-4232_1901498e-e74f-47a9-824b-b08358df8a47 41167-4232 HUMAN OTC DRUG Childrens Allegra Allergy Fexofenadine Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20140102 NDA NDA021909 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE 30 mg/1 41167-4233_aa079b70-d080-4841-af87-6706906596cd 41167-4233 HUMAN OTC DRUG Childrens Allegra Allergy Fexofenadine Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20110303 NDA NDA021909 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE 30 mg/1 41167-4244_cc304ad4-058f-4dea-bec7-0ce07bba6393 41167-4244 HUMAN OTC DRUG Childrens Allegra Allergy Fexofenadine Hydrochloride SUSPENSION ORAL 20110303 NDA NDA201373 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE 6 mg/mL 41167-4255_0e4de333-b970-4623-b91d-3aaa67cdcbe7 41167-4255 HUMAN OTC DRUG Allegra Cooling Relief Anti-Itch Diphenhydramine HCl, Allantoin CREAM TOPICAL 20121201 OTC MONOGRAPH FINAL part347 Chattem, Inc. ALLANTOIN; DIPHENHYDRAMINE HYDROCHLORIDE .5; 2 g/100g; g/100g 41167-4266_0e4de333-b970-4623-b91d-3aaa67cdcbe7 41167-4266 HUMAN OTC DRUG Allegra Intensive Relief Anti-Itch Diphenhydramine HCl, Allantoin CREAM TOPICAL 20121201 OTC MONOGRAPH FINAL part347 Chattem, Inc. ALLANTOIN; DIPHENHYDRAMINE HYDROCHLORIDE .5; 2 g/100g; g/100g 41167-4310_e8efc449-5393-43ea-82e2-40959eb65356 41167-4310 HUMAN OTC DRUG Allegra D 12 Hour Allergy and Congestion fexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110303 NDA NDA020786 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 41167-4320_12f9a56f-8dca-407b-8663-a60e384927ac 41167-4320 HUMAN OTC DRUG Allegra-D 24 Hour Allergy and Congestion fexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110303 NDA NDA021704 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180; 240 mg/1; mg/1 41167-5800_24d54107-9913-4fe4-9512-c4222f282589 41167-5800 HUMAN OTC DRUG Nasacort Allergy 24HR Triamcinolone Acetonide SPRAY, METERED NASAL 20140203 NDA NDA020468 Chattem, Inc. TRIAMCINOLONE ACETONIDE 55 ug/1 41167-6011_166f39a2-6760-4fb6-9ce0-6620231a21f5 41167-6011 HUMAN OTC DRUG Selsun Blue Deep Cleansing Micro-Bead Scrub Salicylic Acid SHAMPOO TOPICAL 20101101 OTC MONOGRAPH FINAL part358H Chattem, Inc. SALICYLIC ACID .03 g/mL 41167-6020_c210aed9-717f-485f-a5a2-3aaf9ba32c22 41167-6020 HUMAN OTC DRUG Selsun Blue Itchy Dry Scalp PYRITHIONE ZINC SHAMPOO TOPICAL 20091201 OTC MONOGRAPH FINAL part358H Chattem, Inc. PYRITHIONE ZINC .01 g/mL 41167-6021_b97dec6c-2851-4abf-88e9-34c687ea3aaa 41167-6021 HUMAN OTC DRUG Selsun Blue Sensitive Scalp Zinc Pyrithione SHAMPOO TOPICAL 20121203 OTC MONOGRAPH FINAL part358H Chattem, Inc. PYRITHIONE ZINC .01 g/mL 41167-6032_7ef78644-cfa9-42ff-bc9d-0a5b392b2195 41167-6032 HUMAN OTC DRUG Selsun Blue Moisturizing Selenium Sulfide SHAMPOO TOPICAL 20020401 OTC MONOGRAPH FINAL part358H Chattem, Inc. SELENIUM SULFIDE 1 g/100mL 41167-6050_16054d90-1818-4270-ad9c-db216e201c48 41167-6050 HUMAN OTC DRUG Kaopectate Regular Strength Cherry Flavor Bismuth subsalicylate LIQUID ORAL 20040430 OTC MONOGRAPH FINAL part335 Chattem, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL 41167-6061_7ef78644-cfa9-42ff-bc9d-0a5b392b2195 41167-6061 HUMAN OTC DRUG Selsun Blue Medicated Selenium Sulfide SHAMPOO TOPICAL 20020401 OTC MONOGRAPH FINAL part358H Chattem, Inc. SELENIUM SULFIDE 1 g/100mL 41167-6100_e6f875f3-f560-4d84-aede-9f11765bb50f 41167-6100 HUMAN OTC DRUG Surfak Stool Softener Docusate calcium CAPSULE, GELATIN COATED ORAL 20090101 OTC MONOGRAPH NOT FINAL part334 Chattem, Inc. DOCUSATE CALCIUM 240 mg/1 41167-6101_d1984dd7-5888-4772-ac13-e02d626ff018 41167-6101 HUMAN OTC DRUG Surfak Stool Softener Docusate calcium CAPSULE, GELATIN COATED ORAL 20090101 OTC MONOGRAPH NOT FINAL part334 Chattem, Inc. DOCUSATE CALCIUM 240 mg/1 41167-6202_7ef78644-cfa9-42ff-bc9d-0a5b392b2195 41167-6202 HUMAN OTC DRUG Selsun Blue Normal to Oily Selenium Sulfide SHAMPOO TOPICAL 20020401 OTC MONOGRAPH FINAL part358H Chattem, Inc. SELENIUM SULFIDE 1 g/100mL 41167-7300_be40e4cb-40e8-4ade-a35d-a32e6fa3347a 41167-7300 HUMAN OTC DRUG Sportscreme Trolamine Salicylate CREAM TOPICAL 19990101 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. TROLAMINE SALICYLATE 10 g/100g 41167-7449_460a653c-06f3-4de8-be91-1f64b3c22c83 41167-7449 HUMAN OTC DRUG Kaopectate Extra Strength Peppermint Flavor Anti Diarrheal bismuth subsalicylate LIQUID ORAL 20030401 OTC MONOGRAPH FINAL part335 Chattem, Inc. BISMUTH SUBSALICYLATE 35 mg/mL 41167-7514_2823d2d4-d0a4-4c71-b06b-11b1812f6e76 41167-7514 HUMAN OTC DRUG Capzasin HP Arthritis Pain Relief Capsaicin CREAM TOPICAL 19981201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. CAPSAICIN .001 g/g 41167-7516_52205963-7ae6-402b-aeb7-823c53b0c660 41167-7516 HUMAN OTC DRUG Capzasin Quick Relief Capsaicin and Menthol GEL TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. CAPSAICIN; MENTHOL .00025; .1 g/g; g/g 41167-7518_3c37e161-26f8-4d7b-a527-62fcfbb7d3f0 41167-7518 HUMAN OTC DRUG Capzasin No Mess Applicator Capsaicin LIQUID TOPICAL 20061201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. CAPSAICIN .0015 g/mL 41167-7773_4f8e7148-7d9c-462e-ba55-3cac8b0a80c7 41167-7773 HUMAN OTC DRUG Herpecin Dimethicone and Meradimate and Octinoxate and Octisalate and Oxybenzone STICK TOPICAL 19960429 OTC MONOGRAPH NOT FINAL part352 Chattem, Inc. DIMETHICONE; MERADIMATE; OCTINOXATE; OCTISALATE; OXYBENZONE 1; 5; 7.5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g 41190-041_32e3541d-d981-494b-9a37-f6fdb9fd068b 41190-041 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20101214 OTC MONOGRAPH FINAL part333D Wakefern Food Corp SALICYLIC ACID 19.8 mg/g 41190-047_3bbcacb2-b844-4f11-9d54-c922de6c1f72 41190-047 HUMAN OTC DRUG ShopRite Acid Reducer Ranitidine TABLET ORAL 20130616 ANDA ANDA078653 Wakefern Food Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 41190-050_4a24ec5c-160b-4dfd-b7cc-1aae83a81624 41190-050 HUMAN OTC DRUG Ibuprofen PM diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20130611 ANDA ANDA079113 Wakefern Food Corporation DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 41190-054_e815d94d-73dc-49ff-b1cf-1aaccc441a31 41190-054 HUMAN OTC DRUG ShopRite Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140325 ANDA ANDA075153 Wakefern Food Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 41190-056_427c7cc3-5d88-47d3-b0f8-95f1eb2483a8 41190-056 HUMAN OTC DRUG ShopRite Ni Calm Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140512 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 41190-063_9919b953-a1e2-4c50-ad27-8ffb073d8d1f 41190-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19890715 OTC MONOGRAPH FINAL part347 Wakefern Food Corp FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL 41190-065_9b3124c1-f11c-4872-ae4c-1e5128ca3474 41190-065 HUMAN OTC DRUG ShopRite Nasal Oxymetazoline HCl SPRAY NASAL 20130709 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 41190-067_900cda58-dec9-44c6-b69a-9816a5100c49 41190-067 HUMAN OTC DRUG ShopRite Triple Antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20140131 OTC MONOGRAPH FINAL part333B Wakefern Food Corporation BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 41190-069_836da0e8-5d49-489a-89b2-71ddca4f8390 41190-069 HUMAN OTC DRUG Petrolatum White Petrolatum JELLY TOPICAL 20090116 OTC MONOGRAPH FINAL part347 Wakefern Food Corporation PETROLATUM 1 g/g 41190-072_1287375e-e493-4d70-9c44-7acf2cca7de7 41190-072 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol. Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 19990528 OTC MONOGRAPH NOT FINAL part356 Wakefern Food Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 41190-074_0b896042-5a4b-40f2-8771-a4e8f6ffb320 41190-074 HUMAN OTC DRUG ShopRite Ibuprofen IB Ibuprofen TABLET, COATED ORAL 20130806 ANDA ANDA077349 Wakefern Food Corporation IBUPROFEN 200 mg/1 41190-094_3a61d6ad-d459-4551-80d1-1050992ff9b1 41190-094 HUMAN OTC DRUG ShopRite Nasal Decongestant PE Phenylephrine Hydrochloride TABLET ORAL 20130709 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 41190-105_17fa9860-fd34-4cd5-b6e2-f162997fe317 41190-105 HUMAN OTC DRUG ShopRite Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20130620 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN 160 mg/5mL 41190-117_d118ed50-419c-4ff5-89e0-018f654882a1 41190-117 HUMAN OTC DRUG ShopRite Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130611 ANDA ANDA202319 Wakefern Food Corporation LANSOPRAZOLE 15 mg/1 41190-121_f175a69c-153b-4f1d-a790-818eb09c4c04 41190-121 HUMAN OTC DRUG shoprite triple antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20141030 OTC MONOGRAPH FINAL part333B Wakefern Food Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP&apos'U]/g; mg/g; [USP&apos'U]/g 41190-124_0fcf3443-59de-42a5-8680-f59a1501a1f3 41190-124 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20090804 OTC MONOGRAPH NOT FINAL part356 Wakefern Food Corp EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 41190-130_08b8ff22-1851-4655-83b7-a59b17603e0f 41190-130 HUMAN OTC DRUG shoprite acetaminophen Acetaminophen SUSPENSION ORAL 20131212 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN 160 mg/5mL 41190-141_141c935c-c630-4fe9-89ff-667339a3c046 41190-141 HUMAN OTC DRUG ShopRite Acid Reducer Famotidine TABLET ORAL 20130802 ANDA ANDA075400 Wakefern Food Corporation FAMOTIDINE 10 mg/1 41190-153_f4c749a8-115a-4f41-b608-af9b0af4b40b 41190-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19981205 OTC MONOGRAPH FINAL part358H Wakern Food Corp. PYRITHIONE ZINC 1 kg/100L 41190-160_4583b50f-d864-41e1-803b-6ca44f6799d5 41190-160 HUMAN OTC DRUG ShopRite Hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20130905 OTC MONOGRAPH FINAL part346 Wakefern Food Corporation COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g 41190-161_439de98a-31d4-4794-8131-274467dcf065 41190-161 HUMAN OTC DRUG ShopRite Infants Acetaminophen Acetaminophen LIQUID ORAL 20130620 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN 160 mg/5mL 41190-163_71639837-6b08-4df7-bb4a-dbcdfbe4bbdf 41190-163 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20100305 OTC MONOGRAPH FINAL part355 Wakefern Food Corp SODIUM FLUORIDE 1 mg/mL 41190-165_d6ad0fd7-e927-4152-a67f-a250d6742574 41190-165 HUMAN OTC DRUG shoprite allergy and congestion relief Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20140325 ANDA ANDA075706 Wakefern Food Corporation LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 41190-166_049fdd02-e13a-4b3c-b215-f2c6b9e4bb7f 41190-166 HUMAN OTC DRUG ShopRite Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20130819 ANDA ANDA074937 Wakefern Food Corporation IBUPROFEN 100 mg/5mL 41190-175_95f8a4cb-06bf-4953-81ba-11b631c2a674 41190-175 HUMAN OTC DRUG ShopRite Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20130814 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN 160 mg/5mL 41190-176_52eb0dd9-833a-4656-abd2-7413b605f134 41190-176 HUMAN OTC DRUG ShopRite Allergy D 12 Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20130917 ANDA ANDA077170 Wakefern Food Corporation CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 41190-186_60e75f81-0bab-4429-9bb8-28da53504f8a 41190-186 HUMAN OTC DRUG ShopRite Sleep Aid Diphenhydramine HCl LIQUID ORAL 20130717 OTC MONOGRAPH FINAL part338 Wakefern Food Corporation DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 41190-187_b8d0b5b5-1447-404b-9145-4772202e85aa 41190-187 HUMAN OTC DRUG ShopRite Pain Relief Acetaminophen TABLET, COATED ORAL 20130814 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN 500 mg/1 41190-194_c6bc3d9c-7bff-45c0-8cba-45c1cef12d38 41190-194 HUMAN OTC DRUG ShopRite Acid Reducer Famotidine TABLET ORAL 20130620 ANDA ANDA077351 Wakefern Food Corporation FAMOTIDINE 20 mg/1 41190-203_60cc66e2-4238-4103-9e2c-8a1b4c12334b 41190-203 HUMAN OTC DRUG Hand Sanitizer with Aloe Alcohol GEL TOPICAL 20110614 OTC MONOGRAPH NOT FINAL part333A Shop Rite ALCOHOL .65 mL/100L 41190-205_6244722d-700e-43cc-9764-b46fab05a23e 41190-205 HUMAN OTC DRUG Therapeutic Plus Coal Tar SHAMPOO TOPICAL 20020415 OTC MONOGRAPH FINAL part358H Wakefern Food Corp. COAL TAR 25 mg/mL 41190-207_ba1b54b8-f747-46dd-95cd-435450d7b43f 41190-207 HUMAN OTC DRUG Wakefern Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20130603 OTC MONOGRAPH NOT FINAL part356 Wakefern POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 41190-208_747acdfe-efa9-42a4-91fb-bdb34fa5d323 41190-208 HUMAN OTC DRUG Wakefern Enamel Guard Fluoride PASTE, DENTIFRICE DENTAL 20140203 OTC MONOGRAPH NOT FINAL part356 Wakefern POTASSIUM NITRITE; SODIUM FLUORIDE 5; .15 g/100g; g/100g 41190-210_817df8af-f419-49fd-9370-3bcc649e72f7 41190-210 HUMAN OTC DRUG Advanced Antiseptic Eucalyptol MOUTHWASH ORAL 20101124 OTC MONOGRAPH NOT FINAL part356 Wakefern Food Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .042; .042; .06; .064 mL/100L; mL/100L; mL/100L; mL/100L 41190-213_ca9bf5e8-9e1d-46b4-a213-79d6c8168151 41190-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20020711 OTC MONOGRAPH FINAL part355 Wakefern Food Corp SODIUM FLUORIDE .05 kg/100L 41190-224_df259d4a-9f49-457b-a0ab-ed30506f3a2f 41190-224 HUMAN OTC DRUG ShopRite Anti Diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20130917 ANDA ANDA075232 Wakefern Food Corporation LOPERAMIDE HYDROCHLORIDE 2 mg/1 41190-243_6715d629-6034-4020-a328-bf54d1a2c970 41190-243 HUMAN OTC DRUG Antibacterial Hand Triclosan LIQUID TOPICAL 20090106 OTC MONOGRAPH FINAL part333A Wakefern Food Corporation TRICLOSAN .15 kg/100L 41190-244_be04cf5b-a4ad-4d5d-b926-beeacf1bb7eb 41190-244 HUMAN OTC DRUG ShopRite Antibacterial Moist WipesAntibacterial Moi Antibacterial Moist Wipes Benzalkonium Chloride CLOTH TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333A Wakefern Food Corp BENZALKONIUM CHLORIDE .13 mg/mL 41190-255_03ea5c2b-9124-466b-965f-6c5b7bcc531b 41190-255 HUMAN OTC DRUG ShopRite Infants Ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20130617 ANDA ANDA075217 Wakefern Food Corporation IBUPROFEN 50 mg/1.25mL 41190-279_9f061bdc-da0f-4ef4-9602-96f713bd47f3 41190-279 HUMAN OTC DRUG shoprite hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141112 OTC MONOGRAPH FINAL part346 Wakefern Food Corporation COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 41190-281_34b3e529-60fc-430d-9e2d-baa02a91533b 41190-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 19920511 OTC MONOGRAPH FINAL part358H Wakfern Food Corporation PYRITHIONE ZINC 1 kg/100L 41190-284_aa96abf4-5318-4b9b-a703-e6dbdcb4f60c 41190-284 HUMAN OTC DRUG ShopRite Adult Tussin dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20130616 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL 41190-296_f60b39aa-0368-4ff6-8a49-107028d4e83c 41190-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20090501 OTC MONOGRAPH FINAL part358H Wakefern Food Corp PYRITHIONE ZINC 1 kg/100L 41190-299_4a69f6ff-b749-43bb-8579-b840087b528e 41190-299 HUMAN OTC DRUG Antiseptic cetylpyridinium chloride MOUTHWASH ORAL 20110708 OTC MONOGRAPH NOT FINAL part356 Wakefern Food Corp CETYLPYRIDINIUM CHLORIDE .7 mg/mL 41190-302_8bc8e46e-b328-4e1b-9d3e-02362e65c482 41190-302 HUMAN OTC DRUG ShopRite Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 20130806 OTC MONOGRAPH FINAL part335 Wakefern Food Corporation BISMUTH SUBSALICYLATE 525 mg/30mL 41190-306_aa21dba1-519d-4148-9d7f-4bf34b349377 41190-306 HUMAN OTC DRUG ShopRite Clear Laxative Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20130806 ANDA ANDA090685 Wakefern Food Corporation POLYETHYLENE GLYCOL 3350 17 g/17g 41190-308_f966767b-820b-4e00-a0d8-c4059ef70cac 41190-308 HUMAN OTC DRUG ShopRite Severe Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130709 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 41190-310_d3ba4788-5bd8-4f29-865b-1b65be1a73ed 41190-310 HUMAN OTC DRUG ShopRite Adult Tussin Guaifenesin SYRUP ORAL 20140512 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation GUAIFENESIN 200 mg/10mL 41190-311_fc92f929-0f74-4b47-a3cb-9031a6ac2afa 41190-311 HUMAN OTC DRUG Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20090409 OTC MONOGRAPH FINAL part358H Wakefern PYRITHIONE ZINC 10 mg/mL 41190-318_29a40f0b-fab3-416e-933d-ff48a3032063 41190-318 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 19900813 OTC MONOGRAPH NOT FINAL part356 Wakefern Food Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 41190-319_22ae9189-ce10-4656-a15b-fce76a704f4f 41190-319 HUMAN OTC DRUG ShopRite Hydrocortisone Hydrocortisone CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part348 Wakefern Food Corporation HYDROCORTISONE 1 g/100g 41190-321_bbc26f47-641a-4921-8820-c2e5c1237c3e 41190-321 HUMAN OTC DRUG ShopRite Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20130618 ANDA ANDA077355 Wakefern Food Corporation CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 41190-335_a578b792-f018-4e6c-b3cb-b6d651703f50 41190-335 HUMAN OTC DRUG ShopRite Ni Calm Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20130617 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 41190-337_4bef722c-ac5c-4496-8255-1956bee70710 41190-337 HUMAN OTC DRUG ShopRite Stomach Relief Bismuth subsalicylate LIQUID ORAL 20130814 OTC MONOGRAPH FINAL part335 Wakefern Food Corporation BISMUTH SUBSALICYLATE 1050 mg/30mL 41190-359_fd3153c9-65fb-4bac-9bc6-42d919a38cd4 41190-359 HUMAN OTC DRUG shoprite adult tussin Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140501 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 41190-368_6b6d4b59-b38c-459c-ad86-ae6cfeb6868e 41190-368 HUMAN OTC DRUG ShopRite Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20130814 ANDA ANDA074661 Wakefern Food Corporation NAPROXEN SODIUM 220 mg/1 41190-374_d572f7cb-5383-4484-ac4f-a8bd7f21d49a 41190-374 HUMAN OTC DRUG ShopRite Migraine Formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20130620 ANDA ANDA075794 Wakefern Food Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 41190-384_df926954-2d76-425b-acac-a48b68e47f58 41190-384 HUMAN OTC DRUG ShopRite Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130723 ANDA ANDA091135 Wakefern Food Corporation DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 41190-425_610cfc7f-d046-4425-9199-47e6c3214128 41190-425 HUMAN OTC DRUG ShopRite Aller Ease Fexofenadine HCl TABLET, FILM COATED ORAL 20130709 ANDA ANDA076447 Wakefern Food Corporation FEXOFENADINE HYDROCHLORIDE 60 mg/1 41190-426_6a6843d7-33e3-443a-b92d-21dbc7e630e5 41190-426 HUMAN OTC DRUG ShopRite Tioconazole 1 Tioconazole OINTMENT VAGINAL 20130917 ANDA ANDA075915 Wakefern Food Corporation TIOCONAZOLE 6.5 g/100g 41190-428_4e9a7c8d-2c0b-48cd-883e-f5560f0e70ad 41190-428 HUMAN OTC DRUG ShopRite Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20130620 OTC MONOGRAPH FINAL part332 Wakefern Food Corporation DIMETHICONE 125 mg/1 41190-432_8f2f3b51-a999-4a40-b9e2-53afc86cd3e4 41190-432 HUMAN OTC DRUG ShopRite Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130917 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 41190-434_e9bf8c6c-6a9e-4f76-9dc9-022d8a424502 41190-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20131005 OTC MONOGRAPH NOT FINAL part356 Wakefern Food Corp EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 41190-437_6270e93a-dba0-4396-a938-dc75f186e5cd 41190-437 HUMAN OTC DRUG ShopRite Pain Relief PM Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20130717 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41190-458_203322f0-9c44-445c-bc31-19b98b12d0a7 41190-458 HUMAN OTC DRUG ShopRite Allergy Cetirizine Hydrochloride TABLET ORAL 20130814 ANDA ANDA078336 Wakefern Food Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 41190-459_36be30b7-4995-4230-866f-ed4959aae452 41190-459 HUMAN OTC DRUG ShopRite Ni Calm Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20130617 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 41190-461_9aac3058-931d-4559-bf62-4363c91ee707 41190-461 HUMAN OTC DRUG ShopRite Ibuprofen IB Ibuprofen TABLET, CHEWABLE ORAL 20130702 ANDA ANDA076359 Wakefern Food Corporation IBUPROFEN 100 mg/1 41190-476_cbffb710-7380-46c8-9625-3d72c2eac5e5 41190-476 HUMAN OTC DRUG ShopRite Allergy Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20130717 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 41190-477_2ebd34f1-ddf5-43cc-a026-72a95e3ad3ee 41190-477 HUMAN OTC DRUG ShopRite Fiber Laxative Calcium polycarbophil TABLET, FILM COATED ORAL 20130716 OTC MONOGRAPH NOT FINAL part334 Wakefern Food Corporation CALCIUM POLYCARBOPHIL 625 mg/1 41190-486_1c16bc54-a366-4275-8e32-744d1f360ceb 41190-486 HUMAN OTC DRUG ShopRite Stool Softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20130828 OTC MONOGRAPH NOT FINAL part334 Wakefern Food Corporation DOCUSATE SODIUM 100 mg/1 41190-498_11026777-ac62-4aee-ba7f-07cfd6b40a00 41190-498 HUMAN OTC DRUG shoprite mucus relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130826 ANDA ANDA078912 Wakefern Food Corporation GUAIFENESIN 600 mg/1 41190-503_ce7404cf-327a-4ae0-bbc7-f54ddeca13d2 41190-503 HUMAN OTC DRUG Complete Beauty Octinoxate, zinc oxide LOTION TOPICAL 20130109 OTC MONOGRAPH FINAL part352 Wakefern Food Corporation OCTINOXATE; ZINC OXIDE 60; 30 mg/mL; mg/mL 41190-516_90d406e5-3c8b-4c10-a35e-3c3cb0f62a22 41190-516 HUMAN OTC DRUG ShopRite Adult Tussin Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20130806 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 41190-517_7380ee70-3cec-42b5-be89-3c830ec8e9d7 41190-517 HUMAN OTC DRUG ShopRite Ibuprofen IB Ibuprofen TABLET, FILM COATED ORAL 20130806 ANDA ANDA077349 Wakefern Food Corporation IBUPROFEN 200 mg/1 41190-544_166dc2f2-c042-41b1-a0a1-b5ac5b829ce9 41190-544 HUMAN OTC DRUG ShopRite Arthritis Pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130806 ANDA ANDA075077 Wakefern Food Corporation ACETAMINOPHEN 650 mg/1 41190-548_dad21929-6bea-426e-b610-b2bef7412101 41190-548 HUMAN OTC DRUG shoprite day calm severe acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140917 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 41190-571_64fce94c-3a1c-45f9-a556-945d966bf9e0 41190-571 HUMAN OTC DRUG ShopRite Aller Ease fexofenadine hcl TABLET, FILM COATED ORAL 20130709 ANDA ANDA076447 Wakefern Food Corporation FEXOFENADINE HYDROCHLORIDE 180 mg/1 41190-590_9c81acfb-9815-4533-9e62-e3fd6126ba11 41190-590 HUMAN OTC DRUG ShopRite Infants Acetaminophen Acetaminophen LIQUID ORAL 20130620 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN 160 mg/5mL 41190-602_c37dd014-2a6f-4993-8b52-6ed4d9a6b914 41190-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part334 Wakefern Food Corp MAGNESIUM SULFATE 1 g/g 41190-603_d4b81d79-3a31-4fc2-9e51-dfce2ba2200e 41190-603 HUMAN OTC DRUG ShopRite Day Calm Severe acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20140903 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 41190-604_664a66eb-d30e-47de-98d2-e124aa8dbd8b 41190-604 HUMAN OTC DRUG ShopRite Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130806 ANDA ANDA072096 Wakefern Food Corporation IBUPROFEN 200 mg/1 41190-612_ba9a2252-4d9c-47b0-a107-6b27ae242301 41190-612 HUMAN OTC DRUG ShopRite Allergy Relief Loratadine TABLET ORAL 20130806 ANDA ANDA076301 Wakefern Food Corporation LORATADINE 10 mg/1 41190-619_b69241c6-9944-4b19-ac98-fbf5d1829027 41190-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20100614 OTC MONOGRAPH FINAL part347 Wakefern Food Corp DIMETHICONE 1.3 kg/100mL 41190-622_61ffe0a0-3fc3-45a1-b813-9cb3ce730a45 41190-622 HUMAN OTC DRUG ShopRite Anti Itch Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20131118 OTC MONOGRAPH NOT FINAL part348 Wakefern Food Corporation DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 41190-641_87ae1c96-b4d6-42bf-bc63-599480635705 41190-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part333A Wakefern Food Corp BENZALKONIUM CHLORIDE .999 mg/mL 41190-647_6529464e-87af-479f-b3a9-6a0daa3f5ef7 41190-647 HUMAN OTC DRUG ShopRite Ibuprophen Ibuprofen TABLET, COATED ORAL 20130806 ANDA ANDA072096 Wakefern Food Corporation IBUPROFEN 200 mg/1 41190-648_d9140ee9-9c7b-4f03-9b0c-b1eec8b53be6 41190-648 HUMAN OTC DRUG shoprite nasal four Phenylephrine hydrochloride SPRAY NASAL 20140917 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 41190-656_8fd12e8b-044c-41a5-bef3-eab832dbecc0 41190-656 HUMAN OTC DRUG ShopRite Day Calm acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20130620 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 41190-660_d3d679b9-af28-4ea6-888e-eac4763e6cb4 41190-660 HUMAN OTC DRUG ShopRite Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20130620 ANDA ANDA074937 Wakefern Food Corporation IBUPROFEN 100 mg/5mL 41190-664_3d87463d-acd6-45f3-8b90-1a8c6237771b 41190-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19951002 OTC MONOGRAPH NOT FINAL part356 Wakefern Food Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 41190-667_b0215527-0117-4d2e-8901-e6e9a43b6de1 41190-667 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19890715 OTC MONOGRAPH FINAL part334 Wakefern Foods Corporation MAGNESIUM CITRATE 1.745 g/29.6mL 41190-668_a37e28ed-5711-4bf8-8392-d68c8637c4a9 41190-668 HUMAN OTC DRUG ShopRite Ni Calm Cough Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20130627 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 41190-679_cae5a252-03d2-4ad7-9efe-ec8cb73a3df0 41190-679 HUMAN OTC DRUG shoprite triple antibiotic Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20140123 OTC MONOGRAPH FINAL part333B Wakefern Food Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 41190-686_96f6b519-3b0a-408d-9579-cccf37bda088 41190-686 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19890715 OTC MONOGRAPH FINAL part334 Wakefern Food Corporation MAGNESIUM CITRATE 1.745 g/29.6mL 41190-703_37eacc4d-f3d9-4fb0-ac5d-b55e2e5adf0d 41190-703 HUMAN OTC DRUG ShopRite Gas Relief Simethicone EMULSION ORAL 20140708 OTC MONOGRAPH FINAL part332 Wakefern Food Corporation DIMETHICONE 20 mg/.3mL 41190-731_62f3c308-7948-46cd-a9cd-dbe3c0512c91 41190-731 HUMAN OTC DRUG Miconazole 3 Combination Pack Miconazole Nitrate KIT 20070529 ANDA ANDA074926 Wakefern Food Corporation 41190-742_ff2bb87e-1101-4c9a-9c14-459450914798 41190-742 HUMAN OTC DRUG ShopRite Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20130620 NDA NDA021920 Wakefern Food Corporation NAPROXEN SODIUM 220 mg/1 41190-751_a71bf9bb-f5d1-4748-b1e7-0cfdc33200ec 41190-751 HUMAN OTC DRUG ShopRite Pain Relief PM Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20130819 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41190-763_2af4bfbf-40eb-4ba2-a6ac-7b647a82bc5a 41190-763 HUMAN OTC DRUG shoprite ni-calm Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20140922 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 41190-799_d38199e7-399b-4140-87f6-e78a37869655 41190-799 HUMAN OTC DRUG ShopRite Adult Tussin Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20130620 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 41190-804_a6f04e1f-80f4-4c2d-9960-0fad3e233c33 41190-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20101130 OTC MONOGRAPH NOT FINAL part333A Wakefern Food Corp ISOPROPYL ALCOHOL .91 mg/mL 41190-822_05a463f4-03f8-44d1-aa9e-da6ffecac693 41190-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 19890715 OTC MONOGRAPH FINAL part347 Wakefern Food Corp WITCH HAZEL 86 kg/100L 41190-831_a698b339-c2a6-4980-8fbc-948e619d9306 41190-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part334 WAKEFERN FOOD CORPORATION MINERAL OIL 999 mg/mL 41190-852_0687d51c-35b3-4897-85a7-cea2069b2d63 41190-852 HUMAN OTC DRUG ShopRite Acid Reducer Maximum Strength Ranitidine TABLET, FILM COATED ORAL 20130616 ANDA ANDA091429 Wakefern Food Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 41190-871_a6a36610-d0a8-4842-8ecf-a85b59aa088c 41190-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE LIQUID TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Wakefern Food Corporation HYDROGEN PEROXIDE .3 kg/100L 41190-882_a16907fc-d3cb-410c-a8ee-c47b0d2cd827 41190-882 HUMAN OTC DRUG ShopRite Infants Simethicone Simethicone EMULSION ORAL 20130616 OTC MONOGRAPH FINAL part332 Wakefern Food Corporation DIMETHICONE 20 mg/.3mL 41190-897_3c2d4ad6-4ea7-42e9-8cbf-0e827b6e6f83 41190-897 HUMAN OTC DRUG ShopRite Ibuprofen Ibuprofen SUSPENSION ORAL 20140512 ANDA ANDA074937 Wakefern Food Corporation IBUPROFEN 100 mg/5mL 41190-903_0dafd054-1bae-424e-b9bd-0f0cb3cc9fd1 41190-903 HUMAN OTC DRUG ShopRite Childrens Multi Symptom Cold Relief Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20130814 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 41190-906_8b9e5330-072e-43a4-9efc-67951c8fec2b 41190-906 HUMAN OTC DRUG ShopRite Childrens Cold and Allergy phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20130709 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 41190-913_452d78f2-5746-4238-976a-c2aeae0a7e52 41190-913 HUMAN OTC DRUG ShopRight Childrens Nighttime Cold and Cough Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20130702 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 41190-915_f0fea5e0-07f2-4252-957b-6b72fdade670 41190-915 HUMAN OTC DRUG ShopRite Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20130806 NDA NDA022032 Wakefern Food Corporation OMEPRAZOLE 20 mg/1 41190-931_1f7cc939-c032-41ad-bf36-e467385c5f88 41190-931 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19980815 OTC MONOGRAPH FINAL part358H Wakefern Food Corp PYRITHIONE ZINC 1 g/100mL 41190-944_837dac58-925c-4f72-aa1f-406c4659afbc 41190-944 HUMAN OTC DRUG ShopRite Day Calm Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20130705 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 41190-950_a40f878d-4102-4e1c-8bf9-77ad9e2063b0 41190-950 HUMAN OTC DRUG ShopRite Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20130620 ANDA ANDA091429 Wakefern Food Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 41190-951_578b2264-5090-4f00-930e-f9c1bd2a552f 41190-951 HUMAN OTC DRUG Instant Hand sanitizer ALCOHOL GEL TOPICAL 20110429 OTC MONOGRAPH NOT FINAL part333A WakeFern Food Corporation ALCOHOL 65 kg/100L 41190-974_517bda5f-421c-4e27-b6ed-476ee327329a 41190-974 HUMAN OTC DRUG ShopRite Childrens Allergy cetirizine hydrochloride LIQUID ORAL 20130702 ANDA ANDA090254 Wakefern Food Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL 41190-977_87e02ef6-8e09-4415-bdf5-5fcc40ef2a59 41190-977 HUMAN OTC DRUG ShopRite Ni Calm Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130702 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 41190-987_41bc9bf6-01eb-4415-ad0e-c91919c50883 41190-987 HUMAN OTC DRUG ShopRite Childrens Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20130828 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 41226-411_b408bdbf-873d-457a-a09f-cfe87d0a948d 41226-411 HUMAN OTC DRUG Kroger Value Aspirin Aspirin TABLET ORAL 20070317 OTC MONOGRAPH NOT FINAL part343 Kroger Company ASPIRIN 325 mg/1 41250-000_e876428c-7ff3-4392-8072-00f2648cafe0 41250-000 HUMAN OTC DRUG MEIJER AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g 41250-001_fb0af682-b24a-4c17-9522-f3bdb5c50182 41250-001 HUMAN OTC DRUG Meijer SPF 8 AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; OCTOCRYLENE; OXYBENZONE .5; 2; 1.5 mL/100mL; mL/100mL; mL/100mL 41250-002_0643e5e6-70b0-43ee-9c74-42244bf772c8 41250-002 HUMAN OTC DRUG enema Saline ENEMA RECTAL 20091106 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 41250-003_e75d7a57-6bb0-4808-aa2f-0e5d4080530c 41250-003 HUMAN OTC DRUG Meijer Baby SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 41250-004_4036d27c-d5cb-4dbe-b0b3-3e992b6f9850 41250-004 HUMAN OTC DRUG Anticavity Rinse Sodium Fluoride MOUTHWASH ORAL 20020627 OTC MONOGRAPH FINAL part355 Meijer Distribution, Inc. SODIUM FLUORIDE .05 kg/100L 41250-005_894fe45a-0ea4-42dd-b807-b3ed5e9f3ff6 41250-005 HUMAN OTC DRUG Meijer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 41250-006_122dc8d1-1afe-4307-8863-6a519aa65432 41250-006 HUMAN OTC DRUG Meijer AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 41250-007_5cf2ab30-e54c-4fc5-b589-a3ad29ce36a2 41250-007 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20080815 OTC MONOGRAPH FINAL part333D Meijer Distribution, Inc SALICYLIC ACID 19.8 mg/g 41250-008_c4dafbf6-05b1-4b03-8a84-0f06eda6f0f9 41250-008 HUMAN OTC DRUG pain relief Acetaminophen SUSPENSION/ DROPS ORAL 19870715 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 80 mg/.8mL 41250-009_5c6108d0-0e87-45ef-ab95-f3ebcdce8d27 41250-009 HUMAN OTC DRUG Meijer SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 41250-010_eb437f9b-f788-46a3-9524-03f80be0e92a 41250-010 HUMAN OTC DRUG Meijer Sport SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 41250-011_4f69ad56-7277-45c3-950b-23d57592d7e8 41250-011 HUMAN OTC DRUG Meijer kids SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 41250-012_eb251ce8-4b84-48c6-b7f2-9cb6a6b8fc57 41250-012 HUMAN OTC DRUG Meijer Oil Free 30 AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 5; 3 mL/100mL; mL/100mL; mL/100mL 41250-013_d64bfc9b-2088-4b4b-860e-7f186d9a3483 41250-013 HUMAN OTC DRUG Meijer Tropical SPF 4 OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc OCTOCRYLENE; OXYBENZONE 1; .5 mL/100mL; mL/100mL 41250-014_eebd1c22-f3b1-4c69-8cc4-21bbc62a75f8 41250-014 HUMAN OTC DRUG cold relief multi symptom Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070831 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 41250-015_3059d7e8-1748-400b-918d-3dcc98d71229 41250-015 HUMAN PRESCRIPTION DRUG Meijer Oil Free SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 41250-016_033d3955-9409-42f3-a960-39f962eed612 41250-016 HUMAN OTC DRUG Meijer Oil Free Faces SPF 30 AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 5; 3 mL/100mL; mL/100mL; mL/100mL 41250-017_ca8e36f2-8b90-4872-85bc-512ded8d9b26 41250-017 HUMAN OTC DRUG Meijer SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 41250-018_cce5d379-b550-4149-8d7f-fcb53567c6b4 41250-018 HUMAN OTC DRUG meijer Itch and Rash Relief Hydrocortisone OINTMENT TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc HYDROCORTISONE 1 g/100g 41250-019_acd2b634-b913-447a-b002-5ee1640f5cfa 41250-019 HUMAN OTC DRUG Meijer Sheer SPF 55 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.8; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 41250-020_4020e419-7e0f-412d-a11c-cfcc5d76707d 41250-020 HUMAN OTC DRUG Meijer Sheer SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 41250-021_c4a3ede4-0b5d-486f-aa59-dfc4d072014a 41250-021 HUMAN OTC DRUG Meijer Sport SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 41250-022_3c2ecd83-e578-42b4-9959-edbb786d7650 41250-022 HUMAN OTC DRUG Heartburn Relief Cimetidine TABLET ORAL 20000105 ANDA ANDA075285 Meijer Distribution Inc CIMETIDINE 200 mg/1 41250-023_066ec766-8049-4d09-adee-ce6292690e41 41250-023 HUMAN OTC DRUG Meijer Suscreen SPF 8 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 41250-024_4041ed1a-f7f1-4c01-bbb8-1fe60b85480f 41250-024 HUMAN OTC DRUG Vaporizing Camphor LIQUID RESPIRATORY (INHALATION) 20110722 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc CAMPHOR (NATURAL) 62 mg/mL 41250-025_114643b7-ddd8-4040-b632-b57ca75d4e9e 41250-025 HUMAN OTC DRUG Meijer Sunscreen SPF 15 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc OCTINOXATE; OXYBENZONE 7.5; 4.5 g/100g; g/100g 41250-026_6b22e27b-14dc-43b2-afdb-32c3f94086b4 41250-026 HUMAN OTC DRUG MEIJER Sport SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g 41250-027_0e72c617-a3ff-41af-8291-5bdf3947675e 41250-027 HUMAN OTC DRUG allergy eye original prescription strength Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 19951212 ANDA ANDA077958 Meijer Distribution Inc KETOTIFEN FUMARATE .25 mg/mL 41250-028_82393b8e-4c93-4965-8165-b779693c22ce 41250-028 HUMAN OTC DRUG Meijer Burn Relief Aloe Vera Pain Relieving Gel LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc LIDOCAINE HYDROCHLORIDE .5 g/100g 41250-029_0814a72c-1ffb-4847-b0c1-cf7660239ae8 41250-029 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050206 ANDA ANDA076775 Meijer Distribution Inc NICOTINE 2 mg/1 41250-030_8baa2976-f084-4240-ad01-c3fcf7ae0dec 41250-030 HUMAN OTC DRUG Meijer Oil Free SPF 15 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc OCTINOXATE; OXYBENZONE 7.5; 2.5 g/100g; g/100g 41250-031_d9bf2076-4d3f-4118-ab38-54ab61631716 41250-031 HUMAN OTC DRUG NiteTime Cough DayTime Cough dextromethorphan HBr, doxylamine succinate KIT 20130213 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc 41250-031_e49d96a0-eaeb-40a3-bebc-dd80a44039a3 41250-031 HUMAN OTC DRUG day time nitetime cough dextromethorphan hbr, doxylamine succinate KIT 19920110 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc 41250-032_cef764e7-8518-42cb-8c43-070e4f6994b9 41250-032 HUMAN OTC DRUG Meijer Sport SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g 41250-033_aefa79bb-a0bb-4dbe-b0be-d80843dbf070 41250-033 HUMAN OTC DRUG Meijer Oil Free SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g 41250-034_0d0886e3-7e80-4a8d-b975-b0571548ee9e 41250-034 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19920915 OTC MONOGRAPH FINAL part347 Meijer Distribution FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL 41250-035_499610fd-adb3-411e-92f2-c9596916b50a 41250-035 HUMAN OTC DRUG MEIJER AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 4.5; 6 g/100g; g/100g; g/100g; g/100g; g/100g 41250-036_e4635e56-d04d-4041-acbb-8d56901e4742 41250-036 HUMAN OTC DRUG MEIJER OIL FREE FACES SPF 30 AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 5; 3 g/100g; g/100g; g/100g 41250-037_8e7dd260-ef45-475e-b4fd-dc4539de6075 41250-037 HUMAN OTC DRUG MEIJER ALOE GEL LIDOCAINE, MENTHOL GEL TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc LIDOCAINE; MENTHOL .7; .2 g/100g; g/100g 41250-038_c7cd8e90-5f43-45e4-ac23-37a556ee00e1 41250-038 HUMAN OTC DRUG MEIJER CLEAR ZINC SPF 50 OCTOCRYLENE, ZINC OXIDE LOTION TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc OCTOCRYLENE; ZINC OXIDE 4; 5 g/100g; g/100g 41250-039_99218410-b086-4147-b025-926df02de19c 41250-039 HUMAN OTC DRUG MEIJER SPF 4 TANNING OIL OCTINOXATE, PADIMATE O LOTION TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc OCTINOXATE; PADIMATE O 2; 1.4 g/100g; g/100g 41250-040_16307cc4-5c83-4dd5-91df-8c67007fe14d 41250-040 HUMAN OTC DRUG Alcohol Extra-Thick Isopropyl Alcohol SWAB TOPICAL 20110406 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution Inc ISOPROPYL ALCOHOL 70 mL/100mL 41250-041_638760c4-6dc8-4f66-adc1-6aa4ab4f38d7 41250-041 HUMAN OTC DRUG Nite Time Cold and Flu acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20060811 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 41250-042_c687f9a0-bf2e-4d48-a34b-f4fa7f91a09f 41250-042 HUMAN OTC DRUG MEIJER SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100g; g/100g; g/100g; g/100g 41250-043_d15316a8-95c7-4efd-be00-6b65ed595304 41250-043 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 19871115 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution, Inc MENTHOL 1.5 mg/g 41250-044_43184abd-2525-402a-a388-85af2e5c13ad 41250-044 HUMAN OTC DRUG nighttime sleep aid Diphenhydramine HCl SOLUTION ORAL 20141204 OTC MONOGRAPH FINAL part338 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 41250-045_5f08b4f8-cab5-44ab-9adb-fabc5dae806f 41250-045 HUMAN OTC DRUG Clean Apple Pyrithione zinc SHAMPOO TOPICAL 20131213 OTC MONOGRAPH FINAL part358H Meijer Distribution PYRITHIONE ZINC 1 g/mL 41250-046_8f4abb10-9f91-401f-b565-6002046c78ea 41250-046 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET, COATED ORAL 20090818 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 500 mg/1 41250-047_543583c0-ddea-4ff3-84a8-39e742e55d69 41250-047 HUMAN OTC DRUG acid reducer maximum strength Ranitidine TABLET ORAL 20080213 ANDA ANDA078653 Meijer Distribution Inc RANITIDINE HYDROCHLORIDE 150 mg/1 41250-049_65632b58-4c1f-4ff6-8df2-32bba5cb9db5 41250-049 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20141031 OTC MONOGRAPH FINAL part341 MEIJER, INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41250-050_e8d3260f-2467-40d4-878b-ee5cc029fcf0 41250-050 HUMAN OTC DRUG Ibuprofen PM diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090408 ANDA ANDA079113 Meijer Distribution Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 41250-052_33be8bac-c0c8-4cdc-a056-ecdd2c5c91f7 41250-052 HUMAN OTC DRUG zzz time Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140207 OTC MONOGRAPH FINAL part338 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41250-054_2f070f59-c0a5-4447-8208-0067b36ac841 41250-054 HUMAN OTC DRUG 12 hour decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19991105 ANDA ANDA075153 Meijer Distribution Inc PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 41250-055_ee845b94-1461-44e8-884d-1d50de79e51b 41250-055 HUMAN OTC DRUG meijer REGULAR SCENT Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution Inc. BENZALKONIUM CHLORIDE .115 g/1 41250-056_dc39089f-8833-4610-be68-2996d2b6f4b5 41250-056 HUMAN OTC DRUG nitetime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20141215 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 41250-057_a12c7771-3162-4dd7-ba91-6ab31584ef28 41250-057 HUMAN OTC DRUG ibuprofen infants ibuprofen SUSPENSION ORAL 20000317 ANDA ANDA075217 Meijer Distribution Inc IBUPROFEN 50 mg/1.25mL 41250-059_fa1db369-fd64-42ad-942e-f6f9abf6128e 41250-059 HUMAN OTC DRUG Healing Petrolatum OINTMENT TOPICAL 20130801 OTC MONOGRAPH FINAL part347 Meijer Distribution, Inc PETROLATUM 340 mg/g 41250-061_acc5f764-dde1-4ae1-88dd-b14c645fece3 41250-061 HUMAN OTC DRUG ZZZTime Diphenhydramine HCl LIQUID ORAL 20130708 OTC MONOGRAPH FINAL part338 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 41250-062_125123a6-bd33-4438-a06f-28635f1a516f 41250-062 HUMAN OTC DRUG meijer Clotrimazole 3 Clotrimazole CREAM VAGINAL 20000412 NDA NDA021143 Meijer Distribution Inc CLOTRIMAZOLE 2 g/100g 41250-063_86f19c2d-aa84-4be8-a286-bc36284f0b97 41250-063 HUMAN OTC DRUG meijer Hydrocortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc HYDROCORTISONE 1 g/100g 41250-065_76c431c3-b615-4318-935f-4650edb17ceb 41250-065 HUMAN OTC DRUG nasal 12 hour Oxymetazoline HCl SPRAY NASAL 19940503 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 41250-069_26d2d7f8-521a-40d8-a9ae-b988cdc94ee9 41250-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 19950407 OTC MONOGRAPH FINAL part347 Meijer Distribution Inc PETROLATUM 1 g/g 41250-070_0f8864f1-7bc6-4ffa-ad7f-118d2f1f5340 41250-070 HUMAN OTC DRUG Creamy Petroleum White petrolatum JELLY TOPICAL 20090129 OTC MONOGRAPH FINAL part347 Meijer Distribution, Inc PETROLATUM .3 mg/100g 41250-072_2a736a32-2ade-49af-a13a-012d36b2ce37 41250-072 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol MOUTHWASH ORAL 19961223 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 41250-073_bfa8b0b5-0c61-42a9-96db-9e3ed50ee709 41250-073 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20140930 NDA NDA021920 MEIJER, INC. NAPROXEN SODIUM 220 mg/1 41250-074_8d4cb97a-3b36-423e-85f2-75d23a675601 41250-074 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 20060621 ANDA ANDA077349 Meijer Distribution Inc IBUPROFEN 200 mg/1 41250-075_cb8723f3-9b72-442e-a153-fc91238cad77 41250-075 HUMAN OTC DRUG meijer Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Meijer Distribution Inc BACITRACIN ZINC 500 [iU]/g 41250-076_7c740786-2e2e-41e8-a20c-5cbd4d129741 41250-076 HUMAN OTC DRUG Meijer Cherry Cough Drops MENTHOL LOZENGE ORAL 20140505 OTC MONOGRAPH FINAL part341 Meijer Distribution, Inc MENTHOL 5.8 mg/1 41250-077_d5a15987-b28a-43e9-b1bc-340e49032c4d 41250-077 HUMAN OTC DRUG Meijer Honey Lemon Cough Drops MENTHOL LOZENGE ORAL 20140506 OTC MONOGRAPH FINAL part341 Meijer Distribution, Inc MENTHOL 7.5 mg/1 41250-078_653de601-2329-4f60-a7a7-c3db932c42fd 41250-078 HUMAN OTC DRUG Meijer Menthol Cough Drops MENTHOL LOZENGE ORAL 20140506 OTC MONOGRAPH FINAL part341 Meijer Distribution, Inc MENTHOL 5.4 mg/1 41250-079_bcb22048-effc-4f06-bace-841d9f76f6de 41250-079 HUMAN OTC DRUG Meijer Softchews calcium carbonate BAR, CHEWABLE ORAL 20140604 OTC MONOGRAPH FINAL part331 MEIJER DISTRIBUTION, INC CALCIUM CARBONATE 1177 mg/1 41250-080_ab1cceb7-52f9-4485-accf-984091776de2 41250-080 HUMAN OTC DRUG Antifungal Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Meijer Distribution Inc TERBINAFINE HYDROCHLORIDE 1 g/100g 41250-081_feaa0d07-013e-433f-8db4-550dc9ff737e 41250-081 HUMAN OTC DRUG miconazole 3 Miconazole nitrate KIT 20000204 ANDA ANDA075329 Meijer Distribution Inc 41250-083_46db2c02-1a06-4d40-81da-e8875b5f83ea 41250-083 HUMAN OTC DRUG ibuprofen cold and sinus Ibuprofen, Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011008 ANDA ANDA074567 Meijer Distribution Inc IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 41250-085_8d0014e0-23e5-4d09-929d-aeed66329b36 41250-085 HUMAN OTC DRUG Childrens 24 hour allergy Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Meijer Distribution Inc LORATADINE 5 mg/5mL 41250-089_ebf04ca7-39e0-4dce-97ea-87b24ee2eb5d 41250-089 HUMAN OTC DRUG meijer anti-itch diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20050920 OTC MONOGRAPH FINAL part348 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g 41250-090_74f85ea5-af0a-474c-aab7-1dc1945434c1 41250-090 HUMAN OTC DRUG daytime nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110429 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc 41250-090_9465174d-1a95-4965-a945-ecaa5d9d8bde 41250-090 HUMAN OTC DRUG daytime nitetime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20140211 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc 41250-090_cfe5f076-3d70-4608-98c7-da73bbb7d89c 41250-090 HUMAN OTC DRUG DayTime NiteTime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20070810 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc 41250-091_b002d2c9-ada0-44e8-b947-1edd77fc4223 41250-091 HUMAN OTC DRUG Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20080408 OTC MONOGRAPH FINAL part347 Meijer LANOLIN; PETROLATUM 133; 459 mg/g; mg/g 41250-094_2768f4ec-e9ce-4b3c-b908-3e4c42cabe31 41250-094 HUMAN OTC DRUG Nasal Decongestant PE Maximum Strength Phenylephrine Hydrochloride TABLET ORAL 20050406 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 41250-099_ecef2a04-e14f-4d17-8f7e-e69f9b3b7064 41250-099 HUMAN OTC DRUG meijer Hydrocortisone Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc HYDROCORTISONE 1 g/100g 41250-101_02c3a513-fe3a-4691-949e-eff61300285e 41250-101 HUMAN OTC DRUG NiteTime Sinus Acetaminophen, Doxylamine succinate and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20100914 OTC MONOGRAPH FINAL part341 MEIJER, INC. ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 41250-102_fc080d56-d4f3-4a35-a46b-d0b18e3c0145 41250-102 HUMAN OTC DRUG Childrens 24 Hour Allergy Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Meijer Distribution Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 41250-105_df86842e-cbbf-4b75-98bd-9cf16ec9813f 41250-105 HUMAN OTC DRUG Pain Relief Acetaminophen SUSPENSION ORAL 19950719 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL 41250-106_689dc410-a14c-42c1-b295-a76a5e47612b 41250-106 HUMAN OTC DRUG Childrens 24 Hour Allergy Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Meijer Distribution Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 41250-110_9b007256-f40f-4ecf-a83a-a2dccdc2df1a 41250-110 HUMAN OTC DRUG feminine povidone-iodine KIT 20091104 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution Inc 41250-111_f40206db-d2ac-44ed-9f87-92fdf1c1f203 41250-111 HUMAN OTC DRUG Meijer Enema Saline Laxative ENEMA RECTAL 20130510 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 41250-112_5013744f-22b6-4766-85a8-6a221c891054 41250-112 HUMAN OTC DRUG Meijer Enema Mineral Oil ENEMA RECTAL 20130510 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc MINERAL OIL 113.115 g/118mL 41250-117_f34ccc97-6d77-40a6-bfe2-8a1b94463da3 41250-117 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 Meijer Distribution Inc LANSOPRAZOLE 15 mg/1 41250-118_0748e196-7936-61b7-e054-00144ff88e88 41250-118 HUMAN OTC DRUG Aspirin Regular Strength ASPIRIN TABLET, COATED ORAL 20141107 OTC MONOGRAPH NOT FINAL part343 Meijer ASPIRIN 325 mg/1 41250-120_51da9329-9146-45b2-b49e-2cd2807b81b0 41250-120 HUMAN OTC DRUG Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20140630 OTC MONOGRAPH NOT FINAL part334 MEIJER, INC. BISACODYL 5 mg/1 41250-121_285d3b79-b0c9-4589-adbb-fbc6ba302fa1 41250-121 HUMAN OTC DRUG Meijer AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen Homosalate, Octinoxate, Octocrylene, and Zinc Oxide LOTION TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 12; 7.5; 2; 3.5 g/100mL; g/100mL; g/100mL; g/100mL 41250-124_3dd08943-ef2f-49b4-a483-eb3fc293252a 41250-124 HUMAN OTC DRUG Antiseptic Rinse Antiseptic MOUTHWASH ORAL 20060808 UNAPPROVED DRUG OTHER Meijer EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 41250-125_6d7262d7-4dad-4983-9951-870abbb944a3 41250-125 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20100709 OTC MONOGRAPH FINAL part332 MEIJER, INC. DIMETHICONE 180 mg/1 41250-130_178f82d8-29d1-4fb3-8a32-5a10c822da07 41250-130 HUMAN OTC DRUG Pain Relief Childrens Acetaminophen SUSPENSION ORAL 19891015 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL 41250-133_45150c08-5686-48a2-a58a-69c1a9dad6ab 41250-133 HUMAN OTC DRUG flu and sore throat multi symptom acetaminophen,pheniramine maleate, phenylephrine hydrochloride POWDER, FOR SUSPENSION ORAL 20100106 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/15000mg; mg/15000mg; mg/15000mg 41250-138_0748e196-795f-61b7-e054-00144ff88e88 41250-138 HUMAN OTC DRUG Cold Relief Multi-Symptom Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141107 OTC MONOGRAPH FINAL part341 Meijer ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 41250-139_f95eac59-aa79-4957-947c-3796f40c9946 41250-139 HUMAN OTC DRUG Cold and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20060913 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 41250-140_3169a655-f6a0-45ea-96f0-45c28334ea05 41250-140 HUMAN OTC DRUG all day relief Naproxen sodium TABLET, FILM COATED ORAL 20040528 ANDA ANDA074661 Meijer Distribution Inc NAPROXEN SODIUM 220 mg/1 41250-141_6a5ce63f-d12a-4968-944c-59b1cd1d729f 41250-141 HUMAN OTC DRUG acid reducer original strength Famotidine TABLET ORAL 20091014 ANDA ANDA075400 Meijer Distribution Inc FAMOTIDINE 10 mg/1 41250-142_0fca45d0-e16c-4a99-888f-14952780a486 41250-142 HUMAN OTC DRUG Vagicaine Maximum Strength Benzocaine, Resorcinol CREAM TOPICAL 20090515 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc BENZOCAINE; RESORCINOL 20; 3 g/100g; g/100g 41250-148_3c5ab2ca-7a86-49a8-8a52-b7b2b50f30de 41250-148 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 19930121 OTC MONOGRAPH NOT FINAL part343 Meijer ACETAMINOPHEN 500 mg/1 41250-153_04e68668-fb73-4504-bb69-3e73d81d7d94 41250-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Meijer Distribution, Inc PYRITHIONE ZINC 1 kg/100L 41250-154_1903c444-a7e9-4445-8dcd-8743698c8428 41250-154 HUMAN OTC DRUG Athletes Foot tolnaftate SPRAY TOPICAL 20041026 OTC MONOGRAPH FINAL part333C Meijer Distribution Inc TOLNAFTATE 1 g/100g 41250-158_84f932b6-0aee-4cf9-b4b9-213560c42c1d 41250-158 HUMAN OTC DRUG Congestion Relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20140917 ANDA ANDA203200 Meijer Distribution Inc IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 41250-159_12e46e96-e083-4504-a432-d3020ee0116b 41250-159 HUMAN OTC DRUG Meijer Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Meijer POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 41250-160_9544ad26-33aa-40f6-ac09-14f047006a44 41250-160 HUMAN OTC DRUG Meijer Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Meijer POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 41250-161_e9ec4bc6-523a-4ee9-acba-cd9fbdeb9c10 41250-161 HUMAN OTC DRUG Pain and Fever Acetaminophen SUSPENSION ORAL 20110826 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL 41250-163_267a8b52-0ffc-405e-a791-06a8f6b8f618 41250-163 HUMAN OTC DRUG ANTIBACTERIAL FOAMING PEAR TRICLOSAN LIQUID TOPICAL 20111118 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .46 mL/100mL 41250-164_b5800e27-5a4a-4807-b777-96303ed44c9f 41250-164 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140501 OTC MONOGRAPH NOT FINAL part356 MEIJER, INC. PHENOL 1.4 g/100mL 41250-165_63167142-8263-40b1-94ba-e709e146093d 41250-165 HUMAN OTC DRUG Allergy Relief D Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20030605 ANDA ANDA075706 Meijer Distribution Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 41250-166_1858a3c5-d013-4a14-bcaa-500d3eb99a24 41250-166 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110613 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .6 mL/100mL 41250-167_4a94616d-7f5f-49d0-8640-cefa8878ddb2 41250-167 HUMAN OTC DRUG MEIJER ANTIBACTERIAL FOAMING TRICLOSAN SOAP TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E MEIJER TRICLOSAN .6 mL/100mL 41250-170_6194e3b3-9c8b-42fe-a434-8d42ea4f6764 41250-170 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050201 ANDA ANDA076789 Meijer Distribution Inc NICOTINE 4 mg/1 41250-173_5dd81bdd-54a0-497b-90ef-6db2ca15f3d4 41250-173 HUMAN OTC DRUG ANTIBACTERIAL FOAMING PLUMERIA TRICLOSAN SOAP TOPICAL 20100720 OTC MONOGRAPH NOT FINAL part333 MEIJER TRICLOSAN .6 mL/100mL 41250-175_e6819b18-796e-4146-a6f6-0f6306f1f9cc 41250-175 HUMAN OTC DRUG pain relief Acetaminophen SUSPENSION ORAL 19931028 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL 41250-176_57a44bb8-1f35-4faa-afdb-4c56c5fb37f4 41250-176 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111021 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .6 mL/100mL 41250-177_6f02d6af-d05a-48a9-94c7-2b9b09c1599d 41250-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING ORIGINAL TRICLOSAN LIQUID TOPICAL 20111118 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .46 mL/100mL 41250-177_dbc2edd0-7a4d-452b-aec5-a2a08b331f19 41250-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING ORIGINAL TRICLOSAN LIQUID TOPICAL 20111118 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .46 mL/100mL 41250-179_7a253af4-4b47-4fcf-a9fe-016bb11c5c48 41250-179 HUMAN OTC DRUG antacid extra strength Calcium carbonate TABLET, CHEWABLE ORAL 19940511 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc CALCIUM CARBONATE 750 mg/1 41250-180_d8c84622-e594-4cb8-bf6f-40510029a2dd 41250-180 HUMAN OTC DRUG ibuprofen cold childrens Ibuprofen, Pseudoephedrine HCl SUSPENSION ORAL 20040204 ANDA ANDA076478 Meijer Distribution Inc IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100; 15 mg/5mL; mg/5mL 41250-181_b772c441-c7ea-4c3f-9e80-1e5200d11d51 41250-181 HUMAN OTC DRUG clear lax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091006 ANDA ANDA090685 Meijer Distribution Inc POLYETHYLENE GLYCOL 3350 17 g/17g 41250-183_01352fe9-793a-4bfe-ace7-3487483b1bce 41250-183 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111021 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .6 mL/100mL 41250-185_99d02e5f-1110-44e0-a644-833cce037cef 41250-185 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111021 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .6 mL/100mL 41250-186_f9273089-17ca-454a-a2fb-99a476b7ba0b 41250-186 HUMAN OTC DRUG ANTIBACTERIAL FOAMING CRANBERRY TRICLOSAN LIQUID TOPICAL 20111118 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .46 mL/100mL 41250-187_00060ff5-c070-42cc-9c37-24fa3808b692 41250-187 HUMAN OTC DRUG ANTIBACTERIAL FOAMING CUCUMBER MELON TRICLOSAN LIQUID TOPICAL 20111117 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .6 mL/100mL 41250-188_14319ba4-3bce-497c-a380-65bd24defc5d 41250-188 HUMAN OTC DRUG hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140305 OTC MONOGRAPH FINAL part346 Meijer Distribution Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 41250-190_44368012-e699-4e28-9074-eeff54db2842 41250-190 HUMAN OTC DRUG nicotine Nicotine polacrilex LOZENGE ORAL 20090916 ANDA ANDA090711 Meijer Distribution Inc NICOTINE 4 mg/1 41250-193_70835347-eaa1-4fef-b8ae-2bc5de5d518a 41250-193 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20140430 OTC MONOGRAPH NOT FINAL part343 MEIJER, INC. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 41250-194_a9612e10-0cb8-4243-91b5-ff3cf026bd40 41250-194 HUMAN OTC DRUG Acid Reducer Maximum Strength Famotidine TABLET ORAL 20060929 ANDA ANDA077351 Meijer Distribution Inc FAMOTIDINE 20 mg/1 41250-198_e0e3dc85-120b-42f0-97ec-b5d001c21bde 41250-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100712 ANDA ANDA078682 MEIJER, INC. IBUPROFEN 200 mg/1 41250-199_8e079e36-deee-47d6-98ed-a63b5a46e08f 41250-199 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100611 ANDA ANDA079114 Meijer Distribution Inc 41250-200_0e1b4d55-e907-4a71-b119-41d025657ba7 41250-200 HUMAN OTC DRUG Meijer Brilliant White Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Meijer SODIUM FLUORIDE .243 g/100g 41250-201_2e407664-92b8-4dd7-8615-c04fb35d8c1d 41250-201 HUMAN OTC DRUG nicotine Nicotine polarilex LOZENGE ORAL 20100115 ANDA ANDA090821 Meijer Distribution Inc NICOTINE 2 mg/1 41250-202_2e783136-e721-4ce5-bb69-ae238dda98a4 41250-202 HUMAN OTC DRUG hair regrowth treatment for women minoxidil SOLUTION TOPICAL 20110407 ANDA ANDA075357 Meijer Distribution Inc MINOXIDIL 2 g/100mL 41250-204_4db261d9-f850-460f-a2b9-3d97bc042944 41250-204 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Meijer Distribution, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 41250-205_eb706f12-ed7e-450d-a077-9bc98feebcf1 41250-205 HUMAN OTC DRUG Athletes Foot Tolnaftate SPRAY TOPICAL 20041026 OTC MONOGRAPH FINAL part333C Meijer Distribution Inc TOLNAFTATE 1 g/100g 41250-206_990e333e-3692-4d24-8636-8d952549441c 41250-206 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050124 ANDA ANDA078325 Meijer Distribution Inc NICOTINE 2 mg/1 41250-213_72872b7f-0214-4421-a637-e11c891317e3 41250-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20020711 OTC MONOGRAPH FINAL part355 Meijer Distribution, Inc SODIUM FLUORIDE .05 kg/100L 41250-214_72498af4-30b6-49f0-b4d8-f9c06bf4791c 41250-214 HUMAN OTC DRUG Meijer Cold and Hot Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Meijer MENTHOL 750 mg/1 41250-215_4a0f5506-1f7f-4281-8f13-038fa5803cb4 41250-215 HUMAN OTC DRUG Meijer Extra Strength Cold and Hot Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Meijer MENTHOL 750 mg/1 41250-217_42575c96-3690-4b41-8861-c733546410a3 41250-217 HUMAN OTC DRUG pain relief 8 hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050326 ANDA ANDA075077 Meijer Distribution Inc ACETAMINOPHEN 650 mg/1 41250-223_741961da-a6a6-4353-b068-819e64c3399c 41250-223 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH ALOE ETHYL ALCOHOL GEL TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 MEIJER DISTRIBUTION INC ALCOHOL 62 mL/100mL 41250-224_06a0530b-b06a-466b-b366-82a2a9f7c05c 41250-224 HUMAN OTC DRUG anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030305 ANDA ANDA075232 Meijer Distribution Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 41250-226_e3fb38f3-fa11-4a62-beea-7145d44e0c0e 41250-226 HUMAN OTC DRUG Baby Diaper Rash Zinc Oxide OINTMENT TOPICAL 20110901 OTC MONOGRAPH FINAL part347 Wholesale Merchandisers, Inc ZINC OXIDE 13 kg/100kg 41250-227_be330151-85fb-40a9-a08d-8c9a6a089bbf 41250-227 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET, COATED ORAL 20050928 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 500 mg/1 41250-229_6fdfe2d3-7ce3-45ad-aca9-5ca4b7f54fef 41250-229 HUMAN OTC DRUG Acne Treatment Benzoyl peroxide GEL TOPICAL 20130715 OTC MONOGRAPH FINAL part333D Meijer BENZOYL PEROXIDE 1 mg/g 41250-234_4fc11d87-69ab-442a-a302-c3bb0422bd25 41250-234 HUMAN OTC DRUG Cold relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20080312 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 41250-236_b8865d18-747a-4013-a60f-d12a068967cb 41250-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 MEIJER, INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 41250-245_a6773bf2-1a2e-475f-ab58-4aad625435bc 41250-245 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 MEIJER, INC. SENNOSIDES 25 mg/1 41250-247_a557dabc-7ae3-4ee6-a49a-de6566c397e8 41250-247 HUMAN OTC DRUG NiteTime Sinus Acetaminophen, Doxylamine succinate, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20130116 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 41250-248_5309b4c8-8386-4229-8395-bdc5e53a2b6d 41250-248 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140328 OTC MONOGRAPH NOT FINAL part343 MEIJER, INC. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 41250-250_f548f62f-e671-49b4-b9bb-11eaf4dff7e6 41250-250 HUMAN OTC DRUG cold relief Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20090807 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc 41250-251_2c118edc-d525-46c4-88a2-2c9a5161dc5e 41250-251 HUMAN OTC DRUG analgesic Trolamine Salicylate CREAM TOPICAL 19900415 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc TROLAMINE SALICYLATE 10 g/100g 41250-253_09006daa-f370-462d-b707-33401fa0eb12 41250-253 HUMAN OTC DRUG MEIJER MUSCLE ULTRA CAMPHOR, MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20120831 OTC MONOGRAPH NOT FINAL part348 MEIJER, INC. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g 41250-254_637af79b-3fd3-4e09-80cf-3f2cbad7810d 41250-254 HUMAN OTC DRUG MEIJER COLD AND HOT THERAPY MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part348 MEIJER, INC. MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g 41250-255_232d7714-edaa-406d-bc7b-400799e7e4cc 41250-255 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20040418 ANDA ANDA075217 Meijer Distribution Inc IBUPROFEN 50 mg/1.25mL 41250-256_52ebfa08-fde4-4fc4-8d75-0cd6af35499c 41250-256 HUMAN OTC DRUG MEIJER CAPSAICIN CAPSAICIN CREAM TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part348 MEIJER, INC. CAPSAICIN .1 g/100g 41250-263_40304e4d-be04-4c20-a953-202866e5904d 41250-263 HUMAN OTC DRUG Meijer Elements Advanced Firming and Anti-Wrinkle Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 5 g/100g; g/100g; g/100g 41250-266_6d450775-018f-49bd-8fd3-0d94ffd6de06 41250-266 HUMAN OTC DRUG Nighttime Allergy Relief Extra Strength Diphenhydramine HCl TABLET ORAL 20140630 OTC MONOGRAPH FINAL part338 MEIJER, INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 41250-269_4b53a83c-de39-46de-b7bc-ad9c6c6602a3 41250-269 HUMAN OTC DRUG Meijer Medicated Heat Capsaicin PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Meijer CAPSICUM .6 mg/1 41250-271_ee3e2c1c-4232-4fbb-b022-caf13653918d 41250-271 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 19980929 ANDA ANDA076760 Meijer Distribution Inc RANITIDINE HYDROCHLORIDE 75 mg/1 41250-272_724e9583-dfa3-4735-930f-9cf90ef74470 41250-272 HUMAN OTC DRUG sinus congestion and pain daytime Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20070117 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 41250-273_0748e196-7975-61b7-e054-00144ff88e88 41250-273 HUMAN OTC DRUG Mucus and Sinus PE ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141107 OTC MONOGRAPH FINAL part341 Meijer ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 41250-274_f03205be-e124-462f-a350-14968a11587c 41250-274 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 19961126 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ASPIRIN 81 mg/1 41250-275_0748e196-798a-61b7-e054-00144ff88e88 41250-275 HUMAN OTC DRUG Cold Relief Severe Head Congestion ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141107 OTC MONOGRAPH FINAL part341 Meijer ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 41250-277_12c096ba-2170-4314-bed5-c5eeaecdea3e 41250-277 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 19920611 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ASPIRIN 81 mg/1 41250-279_1431397e-3515-4794-a494-70667948e14c 41250-279 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141008 OTC MONOGRAPH FINAL part346 Meijer Distribution Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 41250-280_d5788ca8-86a7-4ddf-9ce5-fc3db1e0a11a 41250-280 HUMAN OTC DRUG cough and chest congestion Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140715 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 41250-281_74ac4b56-f7c6-4068-b12e-9d30a1e47f9d 41250-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20020524 OTC MONOGRAPH FINAL part358H Meijer Distribution, Inc PYRITHIONE ZINC 1 kg/100L 41250-289_697ae4c3-0f1d-47b8-90a4-1ea5f59e036c 41250-289 HUMAN OTC DRUG Pain Relief infants Acetaminophen SUSPENSION/ DROPS ORAL 19930813 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 80 mg/.8mL 41250-291_3464da51-c676-4aa3-8270-5a3a5c0b26e7 41250-291 HUMAN OTC DRUG anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 19960821 UNAPPROVED DRUG OTHER Meijer Distribution Inc DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 41250-294_20ac0589-0c14-4f88-9230-a5d3ff02227f 41250-294 HUMAN OTC DRUG hair regrowth treatment Minoxidil AEROSOL, FOAM TOPICAL 20120319 ANDA ANDA091344 Meijer Distribution Inc MINOXIDIL 5 g/100g 41250-296_1714bbd1-55d7-4503-89ac-604f32631cfa 41250-296 HUMAN OTC DRUG cough syrup dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20120725 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL 41250-299_20932906-e5bf-4858-ac54-2e5b96c20b37 41250-299 HUMAN OTC DRUG 12 hour allergy d Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 19880715 ANDA ANDA077170 Meijer Distribution Inc CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 41250-300_464bf8da-7708-465e-9c68-6d342717aa15 41250-300 HUMAN OTC DRUG cold and flu severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20140324 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 41250-302_ff728a12-e634-457a-863a-6b161a1d184b 41250-302 HUMAN OTC DRUG Eye Itch Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140123 ANDA ANDA077958 Meijer Distribution Inc KETOTIFEN FUMARATE .35 mg/mL 41250-304_f513a341-195c-4a74-88b6-8f92d1a8e8cb 41250-304 HUMAN OTC DRUG nasal 12 hour oxymetazoline hydrochloride SPRAY NASAL 19911206 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 41250-305_bc2bed12-f68a-42df-a43c-204939458930 41250-305 HUMAN OTC DRUG meijer Athletes Foot Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Meijer Distribution Inc CLOTRIMAZOLE 10 mg/g 41250-306_8041ac16-a590-4737-ace1-008cfb5d93bf 41250-306 HUMAN OTC DRUG clear lax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091006 ANDA ANDA090685 Meijer Distribution Inc POLYETHYLENE GLYCOL 3350 17 g/17g 41250-308_aafa26a2-aecb-45a6-9e87-2e0e7044a6b4 41250-308 HUMAN OTC DRUG cold relief severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 19930202 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 41250-309_4016ecec-b463-418f-ac75-7f00a682ec1b 41250-309 HUMAN OTC DRUG Fresh Mint Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20040821 OTC MONOGRAPH FINAL part358H Meijer Distribution, Inc PYRITHIONE ZINC 1 kg/100kg 41250-310_4c5089ed-f941-421e-b54b-651cc0f1cf1f 41250-310 HUMAN OTC DRUG Cough Guaifenesin SYRUP ORAL 19870815 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc GUAIFENESIN 100 mg/5mL 41250-311_4c647ea2-70e7-401c-a81e-6425c46859ea 41250-311 HUMAN OTC DRUG Everyday Clean Pyrithione Zinc SHAMPOO TOPICAL 20051011 OTC MONOGRAPH FINAL part358H Meijer Distribution, Inc PYRITHIONE ZINC 1 kg/100L 41250-312_155ce739-d3e3-457c-bcfe-1dfe750767fa 41250-312 HUMAN OTC DRUG Quick Wrinkle Repair Moisturizer Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 4; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL 41250-313_e8fcafb5-6524-4f92-8d2c-18e9c549eaf6 41250-313 HUMAN OTC DRUG naproxen sodium Naproxen sodium TABLET, FILM COATED ORAL 20040528 ANDA ANDA074661 Meijer Distribution Inc NAPROXEN SODIUM 220 mg/1 41250-314_989b09ee-b31d-4f84-9854-fac0c1b6de0a 41250-314 HUMAN OTC DRUG MEIJER MEDICATED WIPES WITCH HAZEL CLOTH TOPICAL 20110601 OTC MONOGRAPH FINAL part346 MEIJER, INC. WITCH HAZEL 5 g/1 41250-315_c5bf8ee9-1d34-49fc-b964-f36be36fe22d 41250-315 HUMAN OTC DRUG MEIJER MEDICATED PADS WITCH HAZEL SOLUTION RECTAL; TOPICAL 20110601 OTC MONOGRAPH FINAL part346 MEIJER, INC. WITCH HAZEL .5 mL/mL 41250-318_794c7428-11b2-4067-81d6-403e5dbd5df6 41250-318 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 19900715 OTC MONOGRAPH NOT FINAL part356 Meijer Distribution, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 41250-321_f03d67db-f31f-4f09-8ee6-a3fd72274653 41250-321 HUMAN OTC DRUG Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080822 ANDA ANDA077355 Meijer Distribution Inc CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 41250-323_94b308aa-5de2-4f5e-896f-1d8b90757027 41250-323 HUMAN OTC DRUG lubricating plus eye carboxymethylcellulose sodium SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130501 OTC MONOGRAPH FINAL part349 Meijer Distribution Inc CARBOXYMETHYLCELLULOSE SODIUM .5 g/100mL 41250-326_44a71a97-24e7-4118-9df6-7057163c3eca 41250-326 HUMAN OTC DRUG Meijer Elements Daily Facial Moisturizer Avobenzone, Octocrylene CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; OCTOCRYLENE 3; 10 g/100mL; g/100mL 41250-328_fc590e0f-2fc3-44eb-a324-f378f10539e9 41250-328 HUMAN OTC DRUG Sore Throat Phenol SPRAY ORAL 19930903 OTC MONOGRAPH NOT FINAL part356 Meijer Distribution Inc PHENOL 1.4 mg/100mL 41250-330_bff8f495-6007-4206-aaf3-7c08a0721b91 41250-330 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20130116 OTC MONOGRAPH FINAL part346 Meijer Distribution Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g 41250-332_e17f24e7-c613-4a3d-8314-31657e0e1753 41250-332 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide LIQUID ORAL 19920826 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 41250-333_740b61e8-1512-4b57-a799-ea0f9b4849dc 41250-333 HUMAN OTC DRUG Enema mineral oil Mineral Oil LIQUID RECTAL 19910808 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc MINERAL OIL 100 mL/100mL 41250-335_95b7830f-3e12-4618-9ebe-fe0c3ca73dd8 41250-335 HUMAN OTC DRUG nitetime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110921 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 41250-337_c1d0cb05-1742-43c7-9205-93bfd3cfa4b9 41250-337 HUMAN OTC DRUG Sinus Congestion and Pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20140328 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 41250-340_2bf809a6-ea33-4783-a45e-053f0dc3e6a4 41250-340 HUMAN OTC DRUG antacid aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 19900815 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 41250-344_ded34629-9956-439e-8ef2-9b789d38d370 41250-344 HUMAN OTC DRUG nicotine Nicotine Polacrilex LOZENGE ORAL 20060301 ANDA ANDA077007 Meijer Distribution Inc NICOTINE 2 mg/1 41250-352_669638d2-1269-4d0a-8344-eafd8f0b09f8 41250-352 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070926 ANDA ANDA078547 Meijer Distribution Inc NICOTINE 2 mg/1 41250-357_e303f89d-44ce-45ae-8975-3039515c2cda 41250-357 HUMAN OTC DRUG Meijer Artificial Tears Lubricant Eye Polyvinyl alcohol, and Povidone SOLUTION/ DROPS OPHTHALMIC 20141229 OTC MONOGRAPH FINAL part349 Meijer, Inc. POLYVINYL ALCOHOL; POVIDONE 5; 6 mg/mL; mg/mL 41250-358_7a608eb6-8598-42cb-8b64-13dd420a6bc3 41250-358 HUMAN OTC DRUG sinus and allergy pe maximum strength Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20060927 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 41250-359_6d8a06a4-cc9c-4df8-99a6-cdcf5624e569 41250-359 HUMAN OTC DRUG cough Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 19910905 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 41250-361_9b139edc-27d1-4baa-b364-3d1656b7a101 41250-361 HUMAN OTC DRUG DayTime Cold and Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20140320 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 41250-365_dfee5ee7-cc2d-4a8e-9dc2-e95a23f88631 41250-365 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20111214 ANDA ANDA091349 Meijer Distribution Inc NICOTINE 2 mg/1 41250-368_b22ed59d-15c9-4167-9039-b314ac9d1b65 41250-368 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET, FILM COATED ORAL 19970123 ANDA ANDA074661 Meijer Distribution Inc NAPROXEN SODIUM 220 mg/1 41250-370_f59ea855-c128-43a3-ba1d-7b53caf6c348 41250-370 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl alcohol GEL TOPICAL 19920424 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc ALCOHOL 616 mg/100mL 41250-371_1f5082b7-503a-48a4-8162-bf326a33cbbc 41250-371 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20140630 OTC MONOGRAPH NOT FINAL part343 MEIJER, INC. ASPIRIN 325 mg/1 41250-374_e3d05b03-c16d-46e4-b482-6ec439fa630c 41250-374 HUMAN OTC DRUG migraine formula Acetaminophen, Aspirin, Caffeine TABLET ORAL 20020430 ANDA ANDA075794 Meijer Distribution Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 41250-377_f22bd36f-bf30-4ecd-a12b-089a14070f16 41250-377 HUMAN OTC DRUG anti diarrheal Loperamide HCl SOLUTION ORAL 19920417 ANDA ANDA073243 Meijer Distribution Inc LOPERAMIDE HYDROCHLORIDE 1 mg/5mL 41250-379_0875bd4c-0d3b-4b25-9b27-f40fc3db34ae 41250-379 HUMAN OTC DRUG allergy childrens Diphenhydramine Hydrochloride LIQUID ORAL 19871115 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 41250-380_344fd59b-5b6c-4fc1-8faa-2863756cb484 41250-380 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 20140519 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc MAGNESIUM CITRATE 1.745 g/29.61mL 41250-384_6fcdd5c0-3d3d-495b-ac70-e83110356576 41250-384 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120827 ANDA ANDA091135 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 41250-387_e393efac-98c5-4c4f-8543-7a83b9d445b1 41250-387 HUMAN OTC DRUG Meijer Elements Long-Lasting Oil-Free Avobenzone, Octisalate, Octocrylene and Oxybenzone CREAM TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 4; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL 41250-388_2c53b5c6-7422-4249-a18a-e9a0c13c6973 41250-388 HUMAN OTC DRUG nasal Oxymetazoline HCl SPRAY NASAL 20020911 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 41250-393_69d02241-b73f-4895-955f-2e4362040fe8 41250-393 HUMAN OTC DRUG cold relief Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20071109 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 41250-394_6213df2e-f37f-444a-848b-58fc531d25b2 41250-394 HUMAN OTC DRUG Hemorrhoidal Cocoa butter, Phenylephrine HCl, Shark liver oil SUPPOSITORY RECTAL 19980505 OTC MONOGRAPH FINAL part346 Meijer Distribution Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2137.5; 75; 6.375 mg/1; mg/1; mg/1 41250-397_53d1d52e-bb16-43e9-80b9-2edefbe4cbc8 41250-397 HUMAN OTC DRUG pain and fever childrens acetaminophen LIQUID ORAL 20120328 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL 41250-400_75529000-ec8a-4fdf-ae68-9747b3f61584 41250-400 HUMAN OTC DRUG Hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 19960206 OTC MONOGRAPH FINAL part346 Meijer Distribution Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 41250-402_2f079c47-cb65-46eb-a94e-4c5ceb2fbd08 41250-402 HUMAN OTC DRUG Cold Relief Head Congestion Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 19930723 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 41250-403_43c3fe72-a4ef-48a6-bc22-a644919c0c5c 41250-403 HUMAN OTC DRUG pain relief Acetaminophen TABLET ORAL 19901115 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 325 mg/1 41250-404_ebab0f1d-8e32-4937-af63-c025dafdffe1 41250-404 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20060201 OTC MONOGRAPH FINAL part334 Meijer Distribution Inc GLYCERIN 1.3 g/1 41250-405_56430e7e-b1c4-4469-8081-3e06ff1423af 41250-405 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET ORAL 19870715 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 500 mg/1 41250-407_62959f3b-90d0-4295-a489-beac2fa81ae8 41250-407 HUMAN OTC DRUG Meijer Cold Sore Treatment Camphor CREAM TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Meijer BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g 41250-408_4cfb507c-dc92-4282-9931-fd9c57510d1a 41250-408 HUMAN OTC DRUG Hydrocortisone with Aloe Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc HYDROCORTISONE 1 g/100g 41250-410_488952c5-1d4e-4e92-b117-338bf301aecd 41250-410 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20070320 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution Inc BENZALKONIUM CHLORIDE .13 mL/mL 41250-416_8e34ab9f-4841-4755-9053-5df928ed4612 41250-416 HUMAN OTC DRUG aspirin regular strength Aspirin TABLET ORAL 19870715 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ASPIRIN 325 mg/1 41250-417_cb78330b-d8a3-4c16-bbb0-d31368a542e6 41250-417 HUMAN OTC DRUG Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130812 ANDA ANDA076518 Meijer Distribution Inc NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 41250-419_5a124c06-1ecb-49d2-8550-aa4caecca7f3 41250-419 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20140423 ANDA ANDA074937 Meijer Distribution Inc IBUPROFEN 100 mg/5mL 41250-422_0d5f5ba5-f52f-4a7c-8494-7acdc466d1dd 41250-422 HUMAN OTC DRUG nicotine mint flavor Nicotine Polacrilex GUM, CHEWING ORAL 20050124 ANDA ANDA078326 Meijer Distribution Inc NICOTINE 4 mg/1 41250-423_ea96cb21-dc4c-4cca-bb6d-d08e59e08c27 41250-423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Meijer Distribution, Inc IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 41250-424_c4af1c9f-fa2d-4d8e-87a8-42bfd4d5952f 41250-424 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20100115 ANDA ANDA090821 Meijer Distribution Inc NICOTINE 4 mg/1 41250-425_27b9ea1a-259d-4e9a-81e2-576f1842bd03 41250-425 HUMAN OTC DRUG aller ease Fexofenadine HCl TABLET, FILM COATED ORAL 20110824 ANDA ANDA076447 Meijer Distribution Inc FEXOFENADINE HYDROCHLORIDE 60 mg/1 41250-426_7f0b0a4a-f8b5-4d86-afad-fe7e7eee2a31 41250-426 HUMAN OTC DRUG tioconazole 1 Tioconazole OINTMENT VAGINAL 20080109 ANDA ANDA075915 Meijer Distribution Inc TIOCONAZOLE 6.5 g/100g 41250-430_1c74601c-591f-442d-a463-da652b66606f 41250-430 HUMAN OTC DRUG headache formula added strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19920306 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 41250-431_9c2d093e-ff57-40df-922c-b857a951682d 41250-431 HUMAN OTC DRUG sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20041017 OTC MONOGRAPH FINAL part338 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41250-432_8a68ca99-fd76-409a-9769-88830e8720a8 41250-432 HUMAN OTC DRUG nasal decongestant maximum strength non drowsy Pseudoephedrine HCl TABLET, FILM COATED ORAL 19910215 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 41250-437_58700e96-53bf-4b25-97e7-534cb4ab5392 41250-437 HUMAN OTC DRUG pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19920626 OTC MONOGRAPH FINAL part338 Meijer Distribution Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41250-439_7efd1324-661b-481c-b6ec-44369ef66ff6 41250-439 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20131213 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc ALCOHOL 616 mL/mL 41250-441_8e004f5c-6372-433d-b0fe-fb2cfbadfeb5 41250-441 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 19970221 ANDA ANDA040167 Meijer Distribution Inc DOXYLAMINE SUCCINATE 25 mg/1 41250-442_bfaaf88b-24db-4524-acf1-4abe0433fa8a 41250-442 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20111214 ANDA ANDA091354 Meijer Distribution Inc NICOTINE 4 mg/1 41250-444_ce55d055-3db2-40f1-b074-1e81f697b616 41250-444 HUMAN OTC DRUG Allergy Relief D Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120410 ANDA ANDA076050 Meijer Distribution Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 41250-447_06aea9e9-75fb-4320-8beb-f78bf3e3ff12 41250-447 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050203 OTC MONOGRAPH NOT FINAL part343 Meijer ACETAMINOPHEN 80 mg/1 41250-449_86600b55-f4f7-4037-936f-4aa0fe158ee8 41250-449 HUMAN OTC DRUG Junior Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 Meijer ACETAMINOPHEN 160 mg/1 41250-450_0eb50cd4-d584-4f1e-924f-1cfed0f5ec98 41250-450 HUMAN OTC DRUG junior strength acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Meijer ACETAMINOPHEN 160 mg/1 41250-452_618b6a5e-5673-41cb-82fb-8f7f92476883 41250-452 HUMAN OTC DRUG Childrens Mapap Acetaminophen TABLET, CHEWABLE ORAL 20041206 OTC MONOGRAPH NOT FINAL part343 Meijer ACETAMINOPHEN 80 mg/1 41250-453_a99cdf7d-2502-4d08-a71e-b92be973c38f 41250-453 HUMAN OTC DRUG multi symptom cold dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20140715 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL 41250-456_175061c4-3425-4e98-a6ad-36bfe66995a6 41250-456 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061031 ANDA ANDA076777 Meijer Distribution Inc NICOTINE 2 mg/1 41250-458_563028e7-c118-41f6-a09b-3f5af81d4bc3 41250-458 HUMAN OTC DRUG 24 hour allergy Cetirizine Hydrochloride TABLET ORAL 19970707 ANDA ANDA078336 Meijer Distribution Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 41250-459_508c211a-00c4-4e86-8d81-ef262cf2684c 41250-459 HUMAN OTC DRUG nitetime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110909 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 41250-460_c662b35d-2095-486d-87ea-db72bbdd4837 41250-460 HUMAN OTC DRUG severe sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20140627 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 41250-461_75c820b8-88ce-41e0-ab2f-eb7f3b19bc04 41250-461 HUMAN OTC DRUG ibuprofen junior strength Ibuprofen TABLET, CHEWABLE ORAL 20040502 ANDA ANDA076359 Meijer Distribution Inc IBUPROFEN 100 mg/1 41250-462_41243520-972a-4076-baa0-da2baba7007b 41250-462 HUMAN OTC DRUG allergy diphenhydramine hydrochloride CAPSULE ORAL 19910115 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41250-466_eb965b41-aa2d-44dd-96a2-5111361cd01e 41250-466 HUMAN OTC DRUG Laxative bisacodyl SUPPOSITORY RECTAL 20121116 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc BISACODYL 10 mg/1 41250-467_1ba5777f-090a-4c10-937a-9e718c5e6fb4 41250-467 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 19920827 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ASPIRIN 81 mg/1 41250-468_9b00435f-962b-45bc-83b9-33d1be1cd647 41250-468 HUMAN OTC DRUG Antacid Calcium carbonate TABLET, CHEWABLE ORAL 19961126 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc CALCIUM CARBONATE 750 mg/1 41250-472_2829f2e8-984c-4af0-a168-e911d811445b 41250-472 HUMAN OTC DRUG Wonderblur Immediate Skin Smoothing Finishing Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 41250-473_3dca3671-5250-4fa0-9ffc-a57f608967ce 41250-473 HUMAN OTC DRUG daytime cough non drowsy Dextromethorphan HBr LIQUID ORAL 20070815 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE 15 mg/15mL 41250-476_c577aa12-f9be-47d0-b556-6d4bc2b5dd32 41250-476 HUMAN OTC DRUG Allergy Relief Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20051118 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 41250-477_9551e84b-19bc-43e7-9c6e-0f24fdeb5abe 41250-477 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20140305 ANDA ANDA074661 Meijer Distribution Inc NAPROXEN SODIUM 220 mg/1 41250-478_b6f659e0-d446-432b-918e-6a20eafdeadc 41250-478 HUMAN OTC DRUG antacid calcium carbonate TABLET, CHEWABLE ORAL 19940503 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc CALCIUM CARBONATE 500 mg/1 41250-479_f1e83e43-011c-4470-bd55-fb2818a9fc84 41250-479 HUMAN OTC DRUG allergy Diphenhydramine Hydrochloride TABLET ORAL 19910906 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41250-480_ebf45dc0-c44f-47a3-a56a-0f737562a642 41250-480 HUMAN OTC DRUG NiteTime Cold Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20141030 OTC MONOGRAPH FINAL part341 MEIJER, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 41250-482_1405fa9a-1d48-4da6-8085-14e3728d2d07 41250-482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20120222 OTC MONOGRAPH FINAL part355 Meijer Distribution, Inc SODIUM FLUORIDE .1 mg/mL 41250-484_27928deb-30e9-4e00-be42-dd05aa8b6bc9 41250-484 HUMAN OTC DRUG pain relief Acetaminophen TABLET ORAL 19870815 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 500 mg/1 41250-485_bb35938a-cc1d-444e-880b-be02b286702b 41250-485 HUMAN OTC DRUG antacid calcium carbonate TABLET, CHEWABLE ORAL 19940503 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc CALCIUM CARBONATE 500 mg/1 41250-489_085e1a47-51f1-4a42-b931-af0c5b5b8bfc 41250-489 HUMAN OTC DRUG antacid Calcium carbonate TABLET, CHEWABLE ORAL 20000720 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc CALCIUM CARBONATE 750 mg/1 41250-490_498a1899-3e3d-4c5e-b08f-297802e29ff1 41250-490 HUMAN OTC DRUG ALL DAY RELIEF Naproxen Sodium TABLET ORAL 19970529 ANDA ANDA074661 Meijer Distribution Inc NAPROXEN SODIUM 220 mg/1 41250-491_a0f5a0d2-4abb-4040-bc46-8e74ae60c2be 41250-491 HUMAN OTC DRUG meijer Miconazole 3 Miconazole Nitrate CREAM VAGINAL 20050302 ANDA ANDA076773 Meijer Distribution Inc MICONAZOLE NITRATE 40 mg/g 41250-496_3574c0bc-6a3a-4fc9-b970-962b397efa72 41250-496 HUMAN OTC DRUG head congestion Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20090805 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc 41250-498_ec97cee3-54c2-4f1d-8fd1-fbe14487592f 41250-498 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130318 ANDA ANDA078912 Meijer Distribution Inc GUAIFENESIN 600 mg/1 41250-499_8e23d7a9-0fb5-4f92-aef5-9c641cb49486 41250-499 HUMAN OTC DRUG meijer antifungal Tolnaftate CREAM TOPICAL 20060217 OTC MONOGRAPH FINAL part333C Meijer Distribution Inc TOLNAFTATE 10 mg/g 41250-500_26e3b5b8-6806-4176-9f3b-b8bf2bed9b6b 41250-500 HUMAN OTC DRUG meijer Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Meijer Distribution Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 41250-502_fec77b91-4142-43e6-a212-024be1e537e7 41250-502 HUMAN OTC DRUG Nausea Relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20141030 UNAPPROVED DRUG OTHER Meijer Distribution Inc DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 41250-504_5dec4a51-9b97-4141-b195-14799fb6293b 41250-504 HUMAN OTC DRUG meijer Triple Antibiotic plus Pain Relief Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Meijer Distribution Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g 41250-505_f6763293-72fc-47df-82bf-805db5759cce 41250-505 HUMAN OTC DRUG meijer Antibiotic Plus Pain Relief Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Meijer Distribution Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g 41250-507_a1213e26-bbd3-4aef-9fe5-55325e768afc 41250-507 HUMAN OTC DRUG mucus and chest congestion Guaifenesin SYRUP ORAL 20140715 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc GUAIFENESIN 200 mg/10mL 41250-509_5f028cd9-e50f-4c62-ac5d-f99f48c110ab 41250-509 HUMAN OTC DRUG elements anti aging vitamin complex 7 in 1 Avobenzone, Ensulizole, Octisalate, Octocrylene LOTION TOPICAL 20090318 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE 2; 1; 4; 1 mL/100mL; mL/100mL; mL/100mL; mL/100mL 41250-512_5455f4f1-2fab-493f-befa-674cde3ef214 41250-512 HUMAN OTC DRUG Meijer Glisten White Fluoride PASTE, DENTIFRICE DENTAL 20140224 OTC MONOGRAPH FINAL part355 Meijer SODIUM MONOFLUOROPHOSPHATE .76 g/100g 41250-513_f9612ddf-5bbc-4756-a195-4fd5547e7bee 41250-513 HUMAN OTC DRUG Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Meijer Distribution, Inc. LORATADINE 10 mg/1 41250-515_3c60e505-89ca-4499-a802-c1c1d07b63ce 41250-515 HUMAN OTC DRUG daytime nitetime sinus Acetaminophen, Doxylamine succinate , Phenylephrine HCl KIT 20070810 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc 41250-516_98432823-e848-422d-b434-7f3beb520d73 41250-516 HUMAN OTC DRUG cough tussin Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 19890315 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 41250-517_5b923a75-d2c2-4643-90c0-d6231f6a8ee5 41250-517 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060426 ANDA ANDA077349 Meijer Distribution Inc IBUPROFEN 200 mg/1 41250-519_501b741f-9c0e-4a8d-b9be-8d4c9159c9f1 41250-519 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Meijer ACETAMINOPHEN 500 mg/1 41250-521_74bd0237-f93d-411b-8bc2-874837df6721 41250-521 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET ORAL 20090527 ANDA ANDA076359 Meijer Distribution Inc IBUPROFEN 100 mg/1 41250-525_adf1b7ab-b7a9-4e12-b2f8-6bd770c8cf80 41250-525 HUMAN OTC DRUG Lice Treatment permethrin LOTION TOPICAL 20000801 ANDA ANDA075014 Meijer Distribution Inc PERMETHRIN 1 mg/100mL 41250-527_f9612ddf-5bbc-4756-a195-4fd5547e7bee 41250-527 HUMAN OTC DRUG Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Meijer Distribution, Inc. LORATADINE 10 mg/1 41250-528_e9c5fcba-d05a-4cc6-b065-79688cf36fae 41250-528 HUMAN OTC DRUG Antacid CALCIUM CARBONATE TABLET, CHEWABLE ORAL 19951113 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc CALCIUM CARBONATE 750 mg/1 41250-532_78573c22-c28c-4ee9-b082-802e34ff4cae 41250-532 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061031 ANDA ANDA076779 Meijer Distribution Inc NICOTINE 4 mg/1 41250-533_0a302ec9-287e-41b2-b486-923577eae514 41250-533 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan HBr and Guiafenesin TABLET, FILM COATED ORAL 20051231 OTC MONOGRAPH FINAL part341 Meijer DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 41250-535_9ba9b8a3-b94b-4cfc-a40a-8bc90ccd8b3b 41250-535 HUMAN OTC DRUG Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 19930826 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ASPIRIN 81 mg/1 41250-544_b8c538af-a209-46f2-9117-8dae071e0b15 41250-544 HUMAN OTC DRUG arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050326 ANDA ANDA075077 Meijer Distribution Inc ACETAMINOPHEN 650 mg/1 41250-546_063accc6-3cae-4b0b-9bdc-40de94a585ce 41250-546 HUMAN OTC DRUG complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080822 ANDA ANDA077355 Meijer Distribution Inc CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 41250-547_44b2df35-cac5-4ad2-8bb7-9ac17a61a027 41250-547 HUMAN OTC DRUG Mucus Relief D Guaifenesin, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20070126 OTC MONOGRAPH FINAL part341 Meijer GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 400; 40 mg/1; mg/1 41250-548_e4a07c13-0ac9-4110-ba57-119346007716 41250-548 HUMAN OTC DRUG daytime cold and flu acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20131230 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 41250-550_5255a3ee-5df4-48a2-a861-460004857cd7 41250-550 HUMAN OTC DRUG Nitetime D Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Pseudoephedrine HCl LIQUID ORAL 19940329 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 500; 15; 6.25; 30 mg/15mL; mg/15mL; mg/15mL; mg/15mL 41250-551_2c4ed4dc-7999-4a15-a6f9-21e9f267ab4b 41250-551 HUMAN OTC DRUG Medicated Body Powder MENTHOL POWDER TOPICAL 20090505 OTC MONOGRAPH FINAL part348 Meijer Distribution, Inc MENTHOL; ZINC OXIDE .15; 1 kg/100kg; kg/100kg 41250-554_e7d1db41-af11-42bf-a135-041251188044 41250-554 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20140228 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL 41250-556_a8fa38a6-e6a4-4d36-92bc-5a4e7233d168 41250-556 HUMAN OTC DRUG Rapid Release Pain Relief PM Acetaminophen and Diphenhydramine HCl CAPSULE ORAL 20071217 OTC MONOGRAPH FINAL part341 Meijer ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41250-565_42c2f2cc-f0a3-4f56-9b95-9354a1c62a2f 41250-565 HUMAN OTC DRUG Day Time Sinus Acetaminophen, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20121221 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 41250-571_376ae6f9-400c-4edd-b342-f587de0ebed0 41250-571 HUMAN OTC DRUG aller ease fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Meijer Distribution Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 41250-572_357b6659-d8f8-4643-9c34-8ec5458b3364 41250-572 HUMAN OTC DRUG Tension Headache Relief Acetaminophen, Caffeine CAPSULE, GELATIN COATED ORAL 20090209 OTC MONOGRAPH NOT FINAL part343 Meijer ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 41250-578_6a286bcb-786b-4729-929b-2aef1b536765 41250-578 HUMAN OTC DRUG Cough Syrup Dextromethorphan HBr, Guaifenesin LIQUID ORAL 19941007 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 41250-580_3264b14b-c34c-46cc-a4fe-a5d4d98d0a6d 41250-580 HUMAN OTC DRUG DayTime NiteTime Cold and Flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140625 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc 41250-588_18b829d4-491f-4035-bf27-063f139a018a 41250-588 HUMAN OTC DRUG Antacid Maximum Strength Aluminum Hydroxide, Magnesium Hydroxide, Simethicone LIQUID ORAL 20051019 OTC MONOGRAPH FINAL part332 Meijer Distribution Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 41250-589_9af2685d-67cb-4865-b70c-033db28004dc 41250-589 HUMAN OTC DRUG Hand wash Benzalkonium chloride LIQUID TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution Inc BENZALKONIUM CHLORIDE 1 mg/mL 41250-590_b95ddf02-b431-4e93-8a36-ab6a63685315 41250-590 HUMAN OTC DRUG pain and fever acetaminophen SUSPENSION ORAL 19930723 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL 41250-595_c78e0895-f813-4d55-bdfa-21932084053f 41250-595 HUMAN OTC DRUG antacid Calcium Carbonate TABLET, CHEWABLE ORAL 19950317 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc CALCIUM CARBONATE 1000 mg/1 41250-597_d41cb988-d39d-4f0d-bda2-633f2bad6d1f 41250-597 HUMAN OTC DRUG NiteTime DayTime Cold and Flu acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20131230 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc 41250-603_932b11b1-f4a0-417a-bfa1-05261a172155 41250-603 HUMAN OTC DRUG Daytime Cold and Flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20131211 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 41250-604_37f72f2b-0c34-4397-900a-141e2ca52418 41250-604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET ORAL 19880215 ANDA ANDA072096 Meijer Distribution Inc IBUPROFEN 200 mg/1 41250-605_7b5ca5e2-270a-43f8-8f0f-c437fcf57d51 41250-605 HUMAN OTC DRUG multi symptom cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20140715 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 41250-609_ff54bcbf-2ae5-4bea-b26b-2ee12866b56a 41250-609 HUMAN OTC DRUG Nitetime D multi symptom cold flu relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID ORAL 19940201 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 500; 15; 6.25; 30 mg/15mL; mg/15mL; mg/15mL; mg/15mL 41250-612_3563fabb-8750-4eab-83d5-d471dac595d6 41250-612 HUMAN OTC DRUG allergy relief Loratadine TABLET ORAL 20070418 ANDA ANDA076301 Meijer Distribution Inc LORATADINE 10 mg/1 41250-615_6ea9efe6-bdbc-4787-b329-66f497863b50 41250-615 HUMAN OTC DRUG itchy eye original prescription strength Ketotifen SOLUTION OPHTHALMIC 20100823 ANDA ANDA077958 Meijer Distribution Inc KETOTIFEN FUMARATE .25 mg/mL 41250-617_345c2fdd-fcb2-4d34-bd10-0038443ff3a3 41250-617 HUMAN OTC DRUG Meijer Ultra Lubricant Eye Polyethylene glycol 400, and Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20141229 OTC MONOGRAPH FINAL part349 Meijer, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL 41250-619_96ec1439-dbe3-406a-b68e-7035c99ffd0e 41250-619 HUMAN OTC DRUG Daily Moisturizing Daily moisturizing LOTION TOPICAL 20060519 OTC MONOGRAPH FINAL part347 Meijer DIMETHICONE 1.3 kg/100kg 41250-620_ddeee52d-19af-4f33-991e-468aa1e39753 41250-620 HUMAN OTC DRUG Motion Sickness Less Drowsy Formula Meclizine HCl TABLET ORAL 20140328 OTC MONOGRAPH FINAL part336 MEIJER, INC. MECLIZINE HYDROCHLORIDE 25 mg/1 41250-622_f2590632-efff-4a7c-894f-10a0e27f8b67 41250-622 HUMAN OTC DRUG Anti Itch Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20100317 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 41250-630_7c71be16-fcf4-4a5b-ae11-209d19480fe4 41250-630 HUMAN OTC DRUG Motion Sickness Dimenhydrinate TABLET ORAL 20140328 OTC MONOGRAPH FINAL part336 MEIJER, INC. DIMENHYDRINATE 50 mg/1 41250-631_be841460-98b4-4448-a494-09ff161fd131 41250-631 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 19980505 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL 41250-640_98171975-cfa7-43f7-8301-9ca58e3eaa1e 41250-640 HUMAN OTC DRUG laxative Bisacodyl SUPPOSITORY RECTAL 19941026 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc BISACODYL 10 mg/1 41250-641_f99dc4d3-1069-43b2-8c36-7bde54722a64 41250-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140602 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution BENZALKONIUM CHLORIDE .999 mg/mL 41250-645_f0a1aca4-77b2-4e37-9377-8a8ad3c9065b 41250-645 HUMAN OTC DRUG loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120511 ANDA ANDA091292 Meijer Distribution Inc LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 41250-647_7fc5b233-5fd9-422f-aea0-4ffbb451bec6 41250-647 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 19881115 ANDA ANDA072096 Meijer Distribution Inc IBUPROFEN 200 mg/1 41250-648_f945e131-f07d-4e15-890b-6035534b8170 41250-648 HUMAN OTC DRUG Nasal Four Phenylephrine hydrochloride SPRAY NASAL 20030303 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 41250-650_11c9712d-c3b2-49cd-9c2b-0f57190c954e 41250-650 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20131218 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL 41250-656_ccb59302-7506-43be-8d58-892f2b3b363a 41250-656 HUMAN OTC DRUG Daytime cold and flu non drowsy acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 19890915 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 41250-657_1fe6dd51-68ad-40b5-a0fd-286c4f49f33c 41250-657 HUMAN OTC DRUG gas relief ultra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20020509 OTC MONOGRAPH FINAL part332 Meijer Distribution Inc DIMETHICONE 180 mg/1 41250-660_f71f3d1d-52c7-44ec-8b8e-bbfef74470d0 41250-660 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 20020319 ANDA ANDA074937 Meijer Distribution Inc IBUPROFEN 100 mg/5mL 41250-663_07499db4-477c-3410-e054-00144ff8d46c 41250-663 HUMAN OTC DRUG Cold and Flu Severe ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141107 OTC MONOGRAPH FINAL part341 Meijer ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 41250-664_a002532d-4746-47af-b8bb-c539146bcaec 41250-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19930811 OTC MONOGRAPH NOT FINAL part356 Meijer Distribution Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 41250-666_e7f83c77-cb85-40b6-8498-60fb4980f8c6 41250-666 HUMAN OTC DRUG cough and sore throat multi symptom Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20051005 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 41250-667_6de053e4-81fe-4298-95ba-9a670c7671f3 41250-667 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 19890815 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc MAGNESIUM CITRATE 1.745 g/29.61mL 41250-668_e9482482-c2e9-42a7-8360-046ffb5a08ce 41250-668 HUMAN OTC DRUG Nitetime Cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20030303 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 41250-677_6c4bd898-b6d5-4ec3-8862-eb4af1aa8bc0 41250-677 HUMAN OTC DRUG Iodine Topical Solution povidone-iodine SOLUTION TOPICAL 20041202 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution Inc POVIDONE-IODINE .1 mg/mL 41250-678_b3ffc767-c18a-4fce-9817-d1a00845210b 41250-678 HUMAN OTC DRUG hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20121026 OTC MONOGRAPH FINAL part346 Meijer Distribution Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 41250-679_a9370c79-6d1e-4fe2-9186-5bec9c6faa48 41250-679 HUMAN OTC DRUG triple antibiotic plus pain relief Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20100317 OTC MONOGRAPH FINAL part333B Meijer Distribution Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 41250-680_a0579dee-9f90-427a-9d97-a29ffc0b5020 41250-680 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140305 ANDA ANDA074661 Meijer Distribution Inc NAPROXEN SODIUM 220 mg/1 41250-685_38374dcd-5f40-4d0c-b0cc-56034caa3449 41250-685 HUMAN OTC DRUG childrens ibuprofen Ibuprofen LIQUID ORAL 19941121 ANDA ANDA074937 Meijer Distribution Inc IBUPROFEN 100 mg/5mL 41250-688_73239c45-f2a1-4e7b-9470-d0873248d31c 41250-688 HUMAN OTC DRUG Sinus relief Oxymetazoline HCl SPRAY NASAL 20030813 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL 41250-693_ce1d3bc0-b00e-41c0-922a-3dcafd4b1603 41250-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19930913 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc MAGNESIUM CITRATE 1.745 g/29.6mL 41250-698_a90f68f9-d760-4919-9633-404ef82eddee 41250-698 HUMAN OTC DRUG cough and sore throat non drowsy Acetaminophen, Dextromethorphan HBr LIQUID ORAL 20051026 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 500; 15 mg/15mL; mg/15mL 41250-699_39c1126c-0cd0-40cc-a363-24a070159c1c 41250-699 HUMAN OTC DRUG Adult CF Cough Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20060811 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 41250-700_f8106559-a3a9-4dd4-a59a-4cb203fce6fd 41250-700 HUMAN OTC DRUG nicotine Nicotine polacrilex LOZENGE ORAL 20090911 ANDA ANDA090711 Meijer Distribution Inc NICOTINE 2 mg/1 41250-701_51e14b50-af28-4132-873a-37e904549c1d 41250-701 HUMAN OTC DRUG Oral Analgesic Maximum Strength Oral Pain Reliever GEL TOPICAL 20100513 OTC MONOGRAPH NOT FINAL part356 Meijer Distribution, Inc. BENZOCAINE 200 mg/g 41250-703_bd867d71-24cc-47ea-b64a-5c9200ce5a6d 41250-703 HUMAN OTC DRUG Oral Analgesic Maximum Strength Benzocaine LIQUID TOPICAL 20100513 OTC MONOGRAPH NOT FINAL part356 Meijer Distribution Inc. BENZOCAINE .2 mL/mL 41250-704_662b6fc6-aef1-4898-9440-9f7d1a55fae4 41250-704 HUMAN OTC DRUG cough and chest congestion Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140715 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 41250-706_69f354c4-fa32-48e6-95e6-8a754e8bdbd0 41250-706 HUMAN OTC DRUG Oral Analgesic Maximum Strength Benzocaine and Menthol PASTE TOPICAL 20100513 OTC MONOGRAPH NOT FINAL part356 Meijer Distribution Inc. BENZOCAINE; MENTHOL 200; 2.5 mg/g; mg/g 41250-709_573de53e-5bc1-4036-8897-c6282acb9ac7 41250-709 HUMAN OTC DRUG Complete Lice Treatment Piperonyl Butoxide, Pyrethrum Extract KIT 20070912 OTC MONOGRAPH FINAL part358G Meijer Distribution Inc 41250-724_e3e15a0b-407e-4c30-9600-e79d4313fbb4 41250-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Meijer Distribution, Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 41250-725_ef157006-559b-47eb-a434-7e2711586e20 41250-725 HUMAN OTC DRUG Childrens Allergy Fexofenadine Hydrochloride Fexofenadine Hydrochloride SUSPENSION ORAL 20141219 ANDA ANDA203330 Meijer Distribution Inc FEXOFENADINE HYDROCHLORIDE 30 mg/5mL 41250-733_80aae1c3-a616-442b-842e-177db957a69c 41250-733 HUMAN OTC DRUG daytime nitetime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20121024 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc 41250-734_13508e46-c5cc-451b-bc3c-593574f59f4f 41250-734 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20130118 ANDA ANDA203690 Meijer Distribution Inc NICOTINE 2 mg/1 41250-737_6664d448-1031-42d5-a7c1-4da6807a3a69 41250-737 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100609 ANDA ANDA079114 Meijer Distribution Inc 41250-740_deeb696f-3441-46ae-83c9-caa176af34b4 41250-740 HUMAN OTC DRUG Meijer Elements 7-in-1 Anti-Aging Vitamin Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 mL/100mL; mL/100mL; mL/100mL 41250-742_91eb3ead-c1d0-4754-9d7a-c571f7a5f6b0 41250-742 HUMAN OTC DRUG naproxen sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20110114 NDA NDA021920 Meijer Distribution Inc NAPROXEN SODIUM 220 mg/1 41250-751_0bde4d1b-254e-4d2e-ac9d-018c00d80512 41250-751 HUMAN OTC DRUG pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120222 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41250-759_9c59a6a5-2c56-42e2-9aad-3cc509c0f160 41250-759 HUMAN OTC DRUG Pain Relief Acetaminophen SUSPENSION ORAL 20090805 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL 41250-763_b4d89cf4-049c-4b14-a462-286af5384ae6 41250-763 HUMAN OTC DRUG Nitetime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl LIQUID ORAL 20131211 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 41250-766_877e91c3-7036-4480-99d2-c8f74c7225bf 41250-766 HUMAN OTC DRUG pain and fever Acetaminophen SUSPENSION ORAL 20111104 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL 41250-770_f923bb8b-7071-4612-b76e-1a0d9c64aa8b 41250-770 HUMAN OTC DRUG Lubricant Eye Polyethylene glycol, Propylene glycol SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130605 OTC MONOGRAPH FINAL part349 Meijer Distribution Inc POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 g/100mL; g/100mL 41250-780_0748e196-794b-61b7-e054-00144ff88e88 41250-780 HUMAN OTC DRUG Aspirin 81 mg ASPIRIN TABLET, DELAYED RELEASE ORAL 20141107 OTC MONOGRAPH NOT FINAL part343 Meijer ASPIRIN 81 mg/1 41250-798_391f6416-7ecd-46e4-9be5-ed22da580bca 41250-798 HUMAN OTC DRUG Hair Regrowth Treatment Extra Strength for Men Minoxidil SOLUTION TOPICAL 20091229 ANDA ANDA075598 Meijer Distribution Inc MINOXIDIL 3 g/60mL 41250-799_5b19d376-7694-4f21-9980-09307e507696 41250-799 HUMAN OTC DRUG tussin cough adult maximum strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20100127 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/5mL; mg/5mL 41250-800_402f4faf-4de0-4af2-b716-cad814424ac0 41250-800 HUMAN OTC DRUG allergy relief Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20140627 ANDA ANDA076447 Meijer Distribution Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 41250-804_4c92be85-4747-4419-acda-4ce01fb4142b 41250-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution ISOPROPYL ALCOHOL .91 mg/mL 41250-807_a9b853aa-4365-40a5-97c6-4c3a0eb77324 41250-807 HUMAN OTC DRUG zinc cold therapy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20080806 UNAPPROVED HOMEOPATHIC Meijer Distribution Inc ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 41250-808_75a23642-86be-4ad2-88a2-aa9c4c02e8f4 41250-808 HUMAN OTC DRUG Foaming Hand Wash Triclosan 0.46% LIQUID TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution TRICLOSAN .46 mg/mL 41250-816_b4044a60-61dd-479c-ac54-ee313a717fbe 41250-816 HUMAN OTC DRUG Dandruff Selenium sulfide SHAMPOO TOPICAL 20130601 OTC MONOGRAPH FINAL part358H Meijer Distribution SELENIUM SULFIDE 10 mg/mL 41250-817_201f8031-0d0c-477d-a42d-94efcf9685e5 41250-817 HUMAN OTC DRUG Nasal oxymetazoline hydrochloride SPRAY NASAL 19961213 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 41250-820_c029c97a-9e7e-44cb-a9e1-62b218c30a54 41250-820 HUMAN OTC DRUG Moisturizer Long lasting, oil free octinoxate, octisalate, oxybenzone LOTION TOPICAL 20090504 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc OCTINOXATE; OCTISALATE; OXYBENZONE 8.86; 5.9; 3.54 mL/118mL; mL/118mL; mL/118mL 41250-822_f3695414-3974-4e9a-89d0-1081f49b4a07 41250-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 19960315 OTC MONOGRAPH FINAL part347 Meijer Distribution, Inc WITCH HAZEL 86 kg/100L 41250-825_b8417956-4c53-444e-823a-a87748eb0a08 41250-825 HUMAN OTC DRUG Miconazole 7 Miconazole nitrate CREAM VAGINAL 20000204 ANDA ANDA074760 Meijer Distribution Inc MICONAZOLE NITRATE 2 g/100g 41250-827_814ee535-9c96-4942-8498-c377e9818873 41250-827 HUMAN OTC DRUG Meijer Baby Quick Relief Diaper Rash Zinc Oxide CREAM TOPICAL 20130501 OTC MONOGRAPH FINAL part347 Meijer Distribution Inc. ZINC OXIDE 13 g/100g 41250-829_06cae098-ea2d-441c-b230-393f09fafbfe 41250-829 HUMAN OTC DRUG pain relief pm rapid release Acetaminophen, Diphenhydramine HCl CAPSULE, COATED ORAL 20100709 OTC MONOGRAPH FINAL part338 Meijer Distribution Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41250-835_5bf41d0e-252e-4f01-92e6-f4e61ad2e907 41250-835 HUMAN OTC DRUG Earwax Removal Kit CARBAMIDE PEROXIDE LIQUID TOPICAL 20141127 OTC MONOGRAPH FINAL part344 Meijer Distribution Inc. CARBAMIDE PEROXIDE 65 mg/mL 41250-836_1183044c-a05f-46f6-963b-f34beaf8cd85 41250-836 HUMAN OTC DRUG Itchy Scalp Pyrithione zinc SHAMPOO TOPICAL 20131213 OTC MONOGRAPH FINAL part358H Meijer Distribution, Inc PYRITHIONE ZINC 10.3 mg/mL 41250-837_5903488e-0eb3-4dbf-af0c-082f5f0dd790 41250-837 HUMAN OTC DRUG pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 19960828 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41250-839_f889d0a8-81d4-45c3-be47-550cc906662c 41250-839 HUMAN OTC DRUG childrens multi symptom cold dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20140917 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 41250-843_7b22f6aa-8ddc-4652-a3d0-43c9519a8187 41250-843 HUMAN OTC DRUG hemorrhoidal cooling Phenylephrine HCl, Witch hazel GEL TOPICAL 20060524 OTC MONOGRAPH FINAL part346 Meijer Distribution Inc PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/100g; g/100g 41250-851_58c5d17a-b0ef-4434-a77f-9791ae957667 41250-851 HUMAN OTC DRUG Antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20030205 OTC MONOGRAPH FINAL part332 Meijer Distribution Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 41250-852_bdb39515-e4ac-4578-86f4-0a7ba2e79bb9 41250-852 HUMAN OTC DRUG acid reducer Ranitidine TABLET, FILM COATED ORAL 20130823 ANDA ANDA091429 Meijer Distribution Inc RANITIDINE HYDROCHLORIDE 150 mg/1 41250-854_4e3495dc-ed9f-476c-b212-943ad470cec9 41250-854 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 19920221 ANDA ANDA078546 Meijer Distribution Inc NICOTINE 4 mg/1 41250-856_1910def2-7668-48cf-bb43-8b1600cf74e1 41250-856 HUMAN OTC DRUG hair regrowth treatment for women Minoxidil SOLUTION TOPICAL 20071219 ANDA ANDA075357 Meijer Distribution Inc MINOXIDIL 2 g/100mL 41250-866_056bad65-3438-4e16-b4ec-e87d32d79342 41250-866 HUMAN OTC DRUG lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070815 OTC MONOGRAPH FINAL part358G Meijer Distribution Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 41250-870_bdb9b057-69f2-4ac7-b013-4747dcccfbf4 41250-870 HUMAN OTC DRUG Itchy Eye Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140123 ANDA ANDA077958 Meijer Distribution Inc KETOTIFEN FUMARATE .35 mg/mL 41250-871_83fb0250-8be3-4c85-a460-84f4a07ed510 41250-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc HYDROGEN PEROXIDE .3 kg/100L 41250-872_caaa9dc4-a787-4240-b654-acf4007561d4 41250-872 HUMAN OTC DRUG nitetime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 19891215 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 41250-873_45f4022c-fca5-4d84-b528-ad487af896fb 41250-873 HUMAN OTC DRUG nicotine Nicotine Polacrilex LOZENGE ORAL 20060301 ANDA ANDA077007 Meijer Distribution Inc NICOTINE 4 mg/1 41250-880_82402593-d5a8-4cdd-b166-8247c1ea058b 41250-880 HUMAN OTC DRUG Antacid Aluminum hydroxide, Magnesium carbonate TABLET, CHEWABLE ORAL 19960905 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 41250-882_640bfec6-c6d5-4a05-b46f-fb38dd0c3a63 41250-882 HUMAN OTC DRUG gas relief infants Simethicone EMULSION ORAL 19990201 OTC MONOGRAPH FINAL part332 Meijer Distribution Inc DIMETHICONE 20 mg/.3mL 41250-884_cb1c65d7-b7cf-43b1-8968-7b851b8b3714 41250-884 HUMAN OTC DRUG Allergy Childrens 24 Hour cetirizine Hydrochloride LIQUID ORAL 20110114 ANDA ANDA090254 Meijer Distribution Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 41250-885_8494a697-73fa-419c-bbec-c8c1d4fd27b7 41250-885 HUMAN OTC DRUG anti itch maximum strength Hydrocortisone GEL TOPICAL 19970924 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc HYDROCORTISONE 1 g/100g 41250-886_908b6b91-eaae-42cb-a564-5676984c1b27 41250-886 HUMAN OTC DRUG sinus congestion and pain Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20070912 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc 41250-897_0c73ece2-9714-4f30-9300-624ecfd78404 41250-897 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990105 ANDA ANDA074937 Meijer Distribution Inc IBUPROFEN 100 mg/5mL 41250-903_746a4e67-adf7-4f18-af3c-74db4eb063c7 41250-903 HUMAN OTC DRUG Pain Relief Plus Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20080801 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 41250-906_4f036940-dc24-4959-9d47-bf439e9e968b 41250-906 HUMAN OTC DRUG cold and allergy childrens phenylephrine hcl, brompheniramine maleate SOLUTION ORAL 20060825 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 41250-908_53a141ad-617d-47bf-bbb2-529f9c40f008 41250-908 HUMAN OTC DRUG Nite Time multi symptom cold flu relief acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20060811 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 41250-909_b8d0b7d4-2484-4674-89d0-bbf338cff086 41250-909 HUMAN OTC DRUG Beauty Hydrating Octinoxate, Zinc Oxide LOTION TOPICAL 20061108 OTC MONOGRAPH NOT FINAL part352 Meijer OCTINOXATE; ZINC OXIDE 61.2; 30.6 mg/mL; mg/mL 41250-910_ca8ba04b-3d67-4d82-b1a5-683ee1e04fdb 41250-910 HUMAN OTC DRUG cough plus chest congestion adult dm max Dextromethorphan HBr, Guaifenesin SUSPENSION ORAL 20141030 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 41250-911_3f7243d9-de2f-4e84-8e89-bb3feaf41ec5 41250-911 HUMAN OTC DRUG childrens ibuprofen oral suspension Ibuprofen SUSPENSION ORAL 20020319 ANDA ANDA074937 Meijer Distribution Inc IBUPROFEN 100 mg/5mL 41250-913_ca8d5a6f-51c5-45ca-80f4-ea82a3643588 41250-913 HUMAN OTC DRUG cold and cough Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20071031 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 41250-915_8a93774a-1124-44ad-85f5-6907b7d2c416 41250-915 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080229 NDA NDA022032 Meijer Distribution Inc OMEPRAZOLE 20 mg/1 41250-916_6ea0dc6b-4837-4c94-877e-0e5c08c4f43c 41250-916 HUMAN OTC DRUG Miconazole 1 Miconazole nitrate KIT 20100609 ANDA ANDA079114 Meijer Distribution Inc 41250-917_32052581-06d7-4fa5-b838-aff2bb07d170 41250-917 HUMAN OTC DRUG Pain Relief Acetaminophen CAPSULE, COATED ORAL 20110218 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 500 mg/1 41250-918_2b214f81-4602-4b88-8b9e-3ea7b195d2b5 41250-918 HUMAN OTC DRUG Zinc Cold Remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20140210 UNAPPROVED HOMEOPATHIC Meijer Distribution Inc ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 41250-923_d4c6005d-ab20-4ed9-ad7e-f55abd41bee1 41250-923 HUMAN OTC DRUG eye itch relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20100823 ANDA ANDA077958 Meijer Distribution Inc KETOTIFEN FUMARATE .25 mg/mL 41250-926_a0f223ea-d9f9-4d5c-b421-176ba0b16bba 41250-926 HUMAN OTC DRUG Daytime Nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20061108 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc 41250-927_c40b9940-5432-43ed-8f6e-5aeb8eead630 41250-927 HUMAN OTC DRUG Meijer Elements Maximum Strength For Diaper Rash Zinc Oxide PASTE TOPICAL 20130501 OTC MONOGRAPH FINAL part347 Meijer Distribution Inc. ZINC OXIDE 40 g/100g 41250-935_21fbef4e-c1cf-48c4-b04e-d8e85bc18272 41250-935 HUMAN OTC DRUG Sinus Congestion and Pain Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20070831 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 41250-941_eb2744f5-69a4-4d56-bf86-1f508219d9a8 41250-941 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20141217 OTC MONOGRAPH FINAL part358H Meijer Distribution, Inc PYRITHIONE ZINC 10 mg/mL 41250-942_72928954-64e1-472f-a1eb-20b32b1eb7db 41250-942 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc BENZALKONIUM CHLORIDE .999 mg/mL 41250-944_fb170371-2e5d-43ca-a259-538a973ee3b8 41250-944 HUMAN OTC DRUG hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20080206 OTC MONOGRAPH FINAL part346 Meijer Distribution Inc GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g 41250-946_87d1fe47-03a7-40d6-aca2-405ba480b28f 41250-946 HUMAN OTC DRUG pain and fever Acetaminophen SUSPENSION ORAL 20110826 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL 41250-949_0c388db8-e3a1-4fda-84df-e00d5d27c2d5 41250-949 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide LIQUID ORAL 20041018 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 41250-950_8bf1bf6c-061f-46cc-9819-e7db17839c8f 41250-950 HUMAN OTC DRUG acid reducer Ranitidine TABLET, FILM COATED ORAL 20110921 ANDA ANDA091429 Meijer Distribution Inc RANITIDINE HYDROCHLORIDE 150 mg/1 41250-952_17fe08c4-4063-45bd-882d-1cbc0f4d0814 41250-952 HUMAN OTC DRUG Dry Scalp Pyrithions Zinc SHAMPOO TOPICAL 19970916 OTC MONOGRAPH FINAL part358H Meijer Distribution, Inc PYRITHIONE ZINC 1 g/100mL 41250-957_6dc2f39b-ec8d-4fe0-a40d-6c0b4f173fa8 41250-957 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20130118 ANDA ANDA203690 Meijer Distribution Inc NICOTINE 4 mg/1 41250-958_3febf0e0-b587-495a-9608-3a2dfbc32791 41250-958 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130708 ANDA ANDA091135 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 41250-959_44d50d79-6e47-429f-8cbe-6fcac4667732 41250-959 HUMAN OTC DRUG childrens pain and fever Acetaminophen LIQUID ORAL 20120328 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL 41250-962_8abecf27-434c-44c6-9ddc-cd139b5bd832 41250-962 HUMAN OTC DRUG Foaming Hand Wash Triclosan 0.46% LIQUID TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution TRICLOSAN .46 mg/mL 41250-964_d8b222c8-df41-4dcb-b9db-0ecd179ab7ba 41250-964 HUMAN OTC DRUG flu and severe cold and cough night time Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20100903 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 41250-966_e1dc9ade-9211-49b2-87aa-49879db2e8c5 41250-966 HUMAN OTC DRUG arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070905 ANDA ANDA075077 Meijer Distribution Inc ACETAMINOPHEN 650 mg/1 41250-969_4dfdbec1-f563-4878-98ac-298cfb0d87e6 41250-969 HUMAN OTC DRUG pain relief and pain relief pm Acetaminophen, Diphenhydramine HCl KIT 20051019 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc 41250-970_1ec33e70-64fe-4ed9-8c07-fc56b707249e 41250-970 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 20141031 OTC MONOGRAPH FINAL part341 MEIJER, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41250-974_f4906234-dcdd-4946-81e3-8077bdb351de 41250-974 HUMAN OTC DRUG 24 hour allergy cetirizine hydrochloride LIQUID ORAL 20080416 ANDA ANDA090254 Meijer Distribution Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 41250-975_56aaf6c3-88a5-45da-8bd7-6948a21838e6 41250-975 HUMAN OTC DRUG pain relief Acetaminophen TABLET ORAL 19950426 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 500 mg/1 41250-977_2620cbd2-8014-4df9-8c74-75df9951ffaa 41250-977 HUMAN OTC DRUG NiteTime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20140211 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 41250-980_d91addd4-fe2a-4f74-84c5-05d4bf2dfc11 41250-980 HUMAN OTC DRUG pain relief infants Acetaminophen SUSPENSION/ DROPS ORAL 20100611 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 80 mg/.8mL 41250-987_38f1d438-528f-4648-bec4-f891721e3805 41250-987 HUMAN OTC DRUG cold and cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20060811 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 41250-990_a63b86be-d17d-42dd-8121-3df332ebba5c 41250-990 HUMAN OTC DRUG Nite Time multi symptom cold flu relief - acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid LIQUID ORAL 20090805 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 41250-991_8f5c88ae-ae56-4762-911f-c080aad00987 41250-991 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 Meijer IBUPROFEN 200 mg/1 41250-994_7dfbfc3a-dfb2-4ba2-b5f8-f8d561422ee3 41250-994 HUMAN OTC DRUG DayTime Cold and Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20140211 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 41250-995_85b920ec-04a9-4965-a149-20c4a442cb2a 41250-995 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19930401 ANDA ANDA077349 Meijer Distribution Inc IBUPROFEN 200 mg/1 41250-999_4905d89c-a40c-40ef-bbad-b3dfe93c59c4 41250-999 HUMAN OTC DRUG meijer Childrens 24 Hour Allergy Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Meijer Distribution Inc LORATADINE 5 mg/5mL 41268-002_9f180c73-181e-4cb2-8f77-8e9a6a1beed3 41268-002 HUMAN OTC DRUG enema Saline ENEMA RECTAL 20091210 OTC MONOGRAPH NOT FINAL part334 Hannaford Brothers Company SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 41268-008_67f51c91-e041-4799-98c1-dc22122ee018 41268-008 HUMAN OTC DRUG Pain Reliever Infants Acetaminophen SUSPENSION/ DROPS ORAL 19950629 OTC MONOGRAPH NOT FINAL part343 Hannaford Brothers Company ACETAMINOPHEN 80 mg/.8mL 41268-029_2d4b9d18-d0bb-479a-983b-d92e0c2364e0 41268-029 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20060515 ANDA ANDA076775 Hannaford Brothers Company NICOTINE 2 mg/1 41268-041_1ec98cf8-c216-4516-b4ee-4332505795f8 41268-041 HUMAN OTC DRUG NightTime acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20060621 OTC MONOGRAPH FINAL part341 Hannaford Brothers Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 41268-046_38f62be1-5219-4a7a-9ff1-5e8256a40cc0 41268-046 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen CAPSULE ORAL 20091230 OTC MONOGRAPH NOT FINAL part343 Hannaford Brothers Company ACETAMINOPHEN 500 mg/1 41268-050_c45fa182-0b85-4601-b660-e4154e858027 41268-050 HUMAN OTC DRUG ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090226 ANDA ANDA079113 Hannaford Brothers Company DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 41268-065_c1f237f2-2c0a-4a8d-b226-a090a0d6fa59 41268-065 HUMAN OTC DRUG nasal extra moisturizing Oxymetazoline HCl SPRAY NASAL 20060421 OTC MONOGRAPH FINAL part341 Hannaford Brothers Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 41268-074_8e6cd748-cd31-49da-b351-fd4a1dd275ca 41268-074 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20060531 ANDA ANDA077349 Hannaford Brothers Company IBUPROFEN 200 mg/1 41268-094_9d157ed3-2177-4693-a96d-434d3f330ed7 41268-094 HUMAN OTC DRUG nasal decongestant pe maximum strength non drowsy Phenylephrine Hydrochloride TABLET ORAL 20050908 OTC MONOGRAPH FINAL part341 Hannaford Brothers Company PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 41268-105_d2fee328-39e4-4e99-9d74-0425aa713765 41268-105 HUMAN OTC DRUG childrens pain reliever Acetaminophen SUSPENSION ORAL 20081028 OTC MONOGRAPH NOT FINAL part343 Hannaford Brothers Company ACETAMINOPHEN 160 mg/5mL 41268-130_83109ab6-de42-44d2-890f-c95a5fa26baf 41268-130 HUMAN OTC DRUG pain reliever childrens Acetaminophen SUSPENSION ORAL 19950629 OTC MONOGRAPH NOT FINAL part343 Hannaford Brothers Company ACETAMINOPHEN 160 mg/5mL 41268-139_56a71e90-6ed0-4518-954e-452efa214fe3 41268-139 HUMAN OTC DRUG cold and allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20061119 OTC MONOGRAPH FINAL part341 Hannaford Brothers Company CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 41268-141_ad72a295-5e3e-46a9-97f9-b67d75bc0995 41268-141 HUMAN OTC DRUG Acid reducer original strength Famotidine TABLET ORAL 20100203 ANDA ANDA075400 Hannaford Brothers Company FAMOTIDINE 10 mg/1 41268-165_e6355f00-264f-471a-950a-8c7e9e4135cc 41268-165 HUMAN OTC DRUG allergy and congestion relief Pseudoephedrine sulfate, Loratadine TABLET, FILM COATED ORAL 20090603 ANDA ANDA075989 Hannaford Brothers Company LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 41268-175_5751407d-b5ac-47fa-bb95-a82b36ae6e6e 41268-175 HUMAN OTC DRUG pain reliever childrens Acetaminophen SUSPENSION ORAL 19991014 OTC MONOGRAPH NOT FINAL part343 Hannaford Brothers Company ACETAMINOPHEN 160 mg/5mL 41268-215_b3280d49-5256-43bc-b25e-82a781f9fcf2 41268-215 HUMAN OTC DRUG daytime non drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20061206 OTC MONOGRAPH FINAL part341 Hannaford Brothers Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 41268-255_2be97372-1b08-4634-9366-346dc12fcb3f 41268-255 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20050316 ANDA ANDA075217 Hannaford Brothers Company IBUPROFEN 50 mg/1.25mL 41268-271_3961b4cd-482e-462e-bd68-2eb0ff22633b 41268-271 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20090811 ANDA ANDA076760 Hannaford Brothers Company RANITIDINE HYDROCHLORIDE 75 mg/1 41268-272_9529d45e-c408-4e4c-b262-585ec1db4574 41268-272 HUMAN OTC DRUG sinus congestion and pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20070113 OTC MONOGRAPH FINAL part341 Hannaford Brothers Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 41268-302_e7c71ec8-1d75-458d-924b-97c3347b0993 41268-302 HUMAN OTC DRUG Stomach Relief Original Strength Bismuth subsalicylate LIQUID ORAL 19950615 OTC MONOGRAPH FINAL part335 Hannaford Brothers Company BISMUTH SUBSALICYLATE 262 mg/15mL 41268-306_40fa3520-586d-4527-ba2e-604f191ad939 41268-306 HUMAN OTC DRUG clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 Hannaford Brothers Company POLYETHYLENE GLYCOL 3350 17 g/17g 41268-310_448325d6-6f49-4804-b6fe-db3a3bc3d820 41268-310 HUMAN OTC DRUG Tussin Chest Congestion Adult Non Drowsy Guaifenesin SYRUP ORAL 20050905 OTC MONOGRAPH FINAL part341 Hannaford Brothers Company GUAIFENESIN 100 mg/5mL 41268-337_c6c2eb8e-6f75-4f7f-a512-fb140c2fe319 41268-337 HUMAN OTC DRUG stomach relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 19950629 OTC MONOGRAPH FINAL part335 Hannaford Brothers Company BISMUTH SUBSALICYLATE 525 mg/15mL 41268-344_13d9231c-35d6-4a95-852e-6b99d1df3d6b 41268-344 HUMAN OTC DRUG nicotine Nicotine polacrilex LOZENGE ORAL 20060421 ANDA ANDA077007 Hannaford Brothers Company NICOTINE 2 mg/1 41268-358_1fc0b171-a9a1-4682-a997-e85091277b4f 41268-358 HUMAN OTC DRUG sinus and allergy pe maximum strength Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20060929 OTC MONOGRAPH FINAL part341 Hannaford Brothers Company CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 41268-359_50f372f4-6763-4231-9110-62edc458cac7 41268-359 HUMAN OTC DRUG tussin cough dm adult Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 19950809 OTC MONOGRAPH FINAL part341 Hannaford Brothers Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 41268-368_ba022a96-39e5-407e-a570-e7f348af1828 41268-368 HUMAN OTC DRUG all day pain relief Naproxen Sodium TABLET, FILM COATED ORAL 19970409 ANDA ANDA074661 Hannaford Brothers Company NAPROXEN SODIUM 220 mg/1 41268-374_df0ecd43-995e-48d5-92c5-6e5c0513f5a0 41268-374 HUMAN OTC DRUG migraine relief Acetaminophen, Aspirin, Caffeine TABLET ORAL 20021031 ANDA ANDA075794 Hannaford Brothers Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 41268-403_449462ef-008e-4758-a4c9-72a230a626e2 41268-403 HUMAN OTC DRUG pain reliever Acetaminophen TABLET ORAL 19950629 OTC MONOGRAPH NOT FINAL part343 Hannaford Brothers Company ACETAMINOPHEN 325 mg/1 41268-405_7ed215cf-b353-4891-9b72-e8799a0335cc 41268-405 HUMAN OTC DRUG Pain Reliever Acetaminophen TABLET ORAL 19950705 OTC MONOGRAPH NOT FINAL part343 Hannaford Brothers Company ACETAMINOPHEN 500 mg/1 41268-416_eb950857-ad28-4b02-a588-6393e7353bf6 41268-416 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19950627 OTC MONOGRAPH NOT FINAL part343 Hannaford Brothers Company ASPIRIN 325 mg/1 41268-422_710346bf-8702-4ee9-84f7-c1fb6d402809 41268-422 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20060515 ANDA ANDA078326 Hannaford Brothers Company NICOTINE 4 mg/1 41268-430_166201e1-d0b8-4318-b7cb-22b94cf3c12a 41268-430 HUMAN OTC DRUG headache formula added strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19950713 OTC MONOGRAPH NOT FINAL part343 Hannaford Brothers Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 41268-432_849230c9-176c-42d3-b0b5-c4646f73ba0b 41268-432 HUMAN OTC DRUG nasal decongestant maximum strength non drowsy Pseudoephedrine HCl TABLET, FILM COATED ORAL 19950705 OTC MONOGRAPH FINAL part341 Hannaford Brothers Company PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 41268-437_445d8fac-ffbf-4ed7-9703-1585a25baf67 41268-437 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19970321 OTC MONOGRAPH FINAL part338 Hannaford Brothers Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41268-441_9149ea04-8433-4eb1-8ee8-b67fae4714ba 41268-441 HUMAN OTC DRUG Sleep aid Doxylamine succinate TABLET ORAL 19970207 ANDA ANDA040167 Hannaford Brothers Company DOXYLAMINE SUCCINATE 25 mg/1 41268-458_64c91cbd-9347-4dd2-9d3b-29bbab0728b6 41268-458 HUMAN OTC DRUG All Day Allergy Cetirizine Hydrochloride TABLET ORAL 20080116 ANDA ANDA078336 Hannaford Brothers Company CETIRIZINE HYDROCHLORIDE 10 mg/1 41268-461_dde25179-091d-47f5-9de6-909861528e55 41268-461 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20040624 ANDA ANDA076359 Hannaford Brothers Company IBUPROFEN 100 mg/1 41268-469_389c6082-4be4-4ae2-8d5f-2a0ee0fd7d01 41268-469 HUMAN OTC DRUG stomach relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 19991203 OTC MONOGRAPH FINAL part335 Hannaford Brothers Company BISMUTH SUBSALICYLATE 262 mg/1 41268-484_13b01db6-1c46-47ff-b233-acbfa20b3c53 41268-484 HUMAN OTC DRUG pain reliever extra strength Acetaminophen TABLET ORAL 19950705 OTC MONOGRAPH NOT FINAL part343 Hannaford Brothers Company ACETAMINOPHEN 500 mg/1 41268-490_bbd08785-0b20-4729-958b-c2699046d507 41268-490 HUMAN OTC DRUG all day pain relief Naproxen Sodium TABLET ORAL 19970409 ANDA ANDA074661 Hannaford Brothers Company NAPROXEN SODIUM 220 mg/1 41268-496_d0f406c7-17e2-48c0-b7c5-bec8d95b96e0 41268-496 HUMAN OTC DRUG cold head congestion Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20071211 OTC MONOGRAPH FINAL part341 Hannaford Brothers Company 41268-532_5c11cd8b-cb57-4a66-b681-1d9e8d18aa6d 41268-532 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20090216 ANDA ANDA076779 Hannaford Brothers Company NICOTINE 4 mg/1 41268-535_5f4c80d6-4590-4907-beac-82eebf183921 41268-535 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, DELAYED RELEASE ORAL 20050426 OTC MONOGRAPH NOT FINAL part343 Hannaford Brothers Company ASPIRIN 81 mg/1 41268-544_78e747d0-3b1b-49b5-b12a-76e747658d79 41268-544 HUMAN OTC DRUG arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000623 ANDA ANDA075077 Hannaford Brothers Company ACETAMINOPHEN 650 mg/1 41268-578_47269c09-73b9-48c2-9f23-451a99b0e19b 41268-578 HUMAN OTC DRUG Tussin Cough DM Adult Sugar Free Dextromethorphan HBr, Guaifenesin LIQUID ORAL 19951207 OTC MONOGRAPH FINAL part341 Hannaford Brothers Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 41268-588_93a2d7c9-20c1-4be2-a001-4f5012c8126e 41268-588 HUMAN OTC DRUG Antacid Maximum Strength Aluminum Hydroxide, Magnesium Hydroxide, Simethicone LIQUID ORAL 20061210 OTC MONOGRAPH FINAL part332 Hannaford Brothers Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 41268-604_16de2971-ae96-474e-aeb5-3042f3a99a33 41268-604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19950629 ANDA ANDA072096 Hannaford Brothers Company IBUPROFEN 200 mg/1 41268-612_ee761388-8f12-43b6-95a8-2aa69fa0a404 41268-612 HUMAN OTC DRUG Allegy Relief 24 hour non drowsy Loratadine TABLET ORAL 20060907 ANDA ANDA076301 Hannaford Brothers Company LORATADINE 10 mg/1 41268-647_6a0791ae-5b0a-417f-825b-0bae06aaf5b8 41268-647 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 19950601 ANDA ANDA072096 Hannaford Brothers Company IBUPROFEN 200 mg/1 41268-660_c1b91ad0-209c-446e-bc67-72530ab2229c 41268-660 HUMAN OTC DRUG Ibuprofen childrens Ibuprofen SUSPENSION ORAL 20090506 ANDA ANDA074937 Hannaford Brothers Company IBUPROFEN 100 mg/5mL 41268-668_69f6662c-94c9-4e5e-879f-73a7b7e59159 41268-668 HUMAN OTC DRUG Night Time Cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20020926 OTC MONOGRAPH FINAL part341 Hannaford Brothers Company DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 6.25 mg/15mL; mg/15mL 41268-807_85b4bda0-291a-4de2-a895-eaf605d8eafb 41268-807 HUMAN OTC DRUG Cold Remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20081029 UNAPPROVED HOMEOPATHIC Hannaford Brothers Company ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 41268-851_9b5f7cfa-f2bf-4354-bd87-2c052fae7efe 41268-851 HUMAN OTC DRUG antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20030130 OTC MONOGRAPH FINAL part332 Hannaford Brothers Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 41268-897_0c61b4a5-1775-4a32-8f25-068fc3411d5c 41268-897 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION ORAL 19990204 ANDA ANDA074937 Hannaford Brothers Company IBUPROFEN 100 mg/5mL 41268-903_6ddc30e0-c12d-41e5-b109-7746f0f43205 41268-903 HUMAN OTC DRUG plus multi symptom cold childrens pain relief Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20081029 OTC MONOGRAPH FINAL part341 Hannaford Brothers Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 41268-977_9b56b2bd-5e75-4636-bd52-bb51d13484dd 41268-977 HUMAN OTC DRUG Night Time Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20060609 OTC MONOGRAPH FINAL part341 Hannaford Brothers Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 41391-119_c8770f51-48fa-475a-b159-4604ac225fcb 41391-119 HUMAN OTC DRUG Myo-Breathe Menthol GEL TOPICAL 20090110 OTC MONOGRAPH FINAL part346 Myo-Breathe MENTHOL 4000 mg/4mL 41415-046_9dca0d42-305b-40f9-8142-a647f4acee07 41415-046 HUMAN OTC DRUG Publix allergy diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20050920 OTC MONOGRAPH FINAL part348 Publix Super Markets Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g 41415-047_82d19ede-7cb1-456a-99be-0088e54c18d1 41415-047 HUMAN OTC DRUG Publix Hydro Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Publix Super Markets Inc HYDROCORTISONE 1 g/100g 41415-048_f82ebb8d-188a-4b7e-b180-814a08498001 41415-048 HUMAN OTC DRUG Publix hydro plus Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Publix Super Markets Inc HYDROCORTISONE 1 g/100g 41415-049_994801ff-18f6-4f2b-a033-4adef321a1b6 41415-049 HUMAN OTC DRUG Publix antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Publix Super Markets Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 41415-050_ce87048b-b96f-4b61-bf17-69d8a447b5e1 41415-050 HUMAN OTC DRUG Publix antibiotic plus pain relief Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Publix Super Markets Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g 41415-051_6de8fc94-d9a5-4d93-b025-3d2a31e5e036 41415-051 HUMAN OTC DRUG Publix Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Publix Super Markets Inc BACITRACIN ZINC 500 [iU]/g 41415-056_840b3bc9-48c9-4b16-ad4c-ca31c5037776 41415-056 HUMAN OTC DRUG Publix athletic foot Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Publix Super Markets Inc CLOTRIMAZOLE 10 mg/g 41415-076_d19f0b93-6d58-4590-ab20-cdb8de757249 41415-076 HUMAN OTC DRUG Publix antibiotic plus Pain Relief Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Publix Super Markets Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g 41415-210_eea2cc09-e468-4bae-bbfc-8f0ed9df1fb9 41415-210 HUMAN OTC DRUG Advanced Citrus Antiseptic Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 20010503 OTC MONOGRAPH NOT FINAL part356 Publix Supermarkets, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 mL/100L; mL/100L; mL/100L; mL/100L 41442-110_33b6c804-5246-4826-8e76-6d9b636948c3 41442-110 HUMAN OTC DRUG Complexion Enhancer SPF15 Titanium dioxide and Zinc oxide CREAM TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Omorovicza Kozmetikai Kft. TITANIUM DIOXIDE; ZINC OXIDE .75; 1.6 mL/50mL; mL/50mL 41442-123_8967b214-754c-4655-adf8-c51b95e94253 41442-123 HUMAN OTC DRUG Complexion Brightener SPF20 Titanium dioxide and Zinc oxide CREAM TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Omorovicza Kozmetikai Kft. TITANIUM DIOXIDE; ZINC OXIDE .84; 2.1 mL/30mL; mL/30mL 41442-133_99c23df0-8293-412b-b9a6-3b72fadc024a 41442-133 HUMAN OTC DRUG Sunkiss SPF15 titanium dioxide and zinc oxide CREAM TOPICAL 20110506 OTC MONOGRAPH NOT FINAL part352 Omorovicza Kozmetikai Kft TITANIUM DIOXIDE; ZINC OXIDE .675; 3 mL/50mL; mL/50mL 41442-143_68ceb3b7-b0ff-4ecb-a663-eeecee917e60 41442-143 HUMAN OTC DRUG Complexion Perfector BB SPF20 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120227 OTC MONOGRAPH NOT FINAL part352 Omorovicza Kozmetikai Kft. TITANIUM DIOXIDE; ZINC OXIDE 2.2; 3.7 mL/50mL; mL/50mL 41442-149_78efc956-0494-456a-ba69-3941dd949e91 41442-149 HUMAN OTC DRUG Complexion Corrector SPF20 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20130125 OTC MONOGRAPH NOT FINAL part352 Omorovicza Kozmetikai Kft. TITANIUM DIOXIDE; ZINC OXIDE 28; 70 mg/mL; mg/mL 41442-150_496c67cd-cbed-4931-8cd5-04c35c531746 41442-150 HUMAN OTC DRUG Complexion Perfector BB SPF20 Medium Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20130318 OTC MONOGRAPH NOT FINAL part352 Omorovicza Kozmetikai Kft. TITANIUM DIOXIDE; ZINC OXIDE 62; 74 mg/mL; mg/mL 41477-420_dad1ae70-b04b-4a43-9001-9d0a39df9104 41477-420 HUMAN OTC DRUG FIRSTLINE MEDICAL the i-stick Povidone-Iodine Antiseptic Ampules POVIDONE-IODINE LIQUID TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333A The Wild Side, Llc dba Firstline Medical POVIDONE-IODINE 100 mg/mL 41499-105_9445eaa1-1039-487f-baa3-3e9b28d9f43d 41499-105 HUMAN OTC DRUG Amar Petroleum All Purpose Adults Petrolatum JELLY TOPICAL 20100501 OTC MONOGRAPH FINAL part347 Amar Remedies Limited PETROLATUM 99.8 g/100g 41499-106_2afb264a-4297-4573-8c55-0d20ca4d62bb 41499-106 HUMAN OTC DRUG Amar Regular Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20091201 OTC MONOGRAPH FINAL part355 Amar Remedies Limited - Mumbai SODIUM MONOFLUOROPHOSPHATE .76 g/100g 41499-107_356bdab6-1be3-49ca-aacb-98bca738b55a 41499-107 HUMAN OTC DRUG Amar Advanced Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20091201 OTC MONOGRAPH FINAL part355 Amar Remedies Limited - Mumbai SODIUM FLUORIDE .22 g/100g 41499-122_ea0fd21e-543e-452d-a5a5-cb271224eed0 41499-122 HUMAN OTC DRUG Amar Vaporizing Chest Rub Camphor (Synthetic), Eucalyptus Oil, and Menthol OINTMENT TOPICAL 20100501 OTC MONOGRAPH FINAL part341 Amar Remedies Limited - Mumbai CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 5.25; 1.6; 3.15 g/100g; g/100g; g/100g 41499-123_dfe38d4d-50ba-41f2-afbd-772970bc3cff 41499-123 HUMAN OTC DRUG Amar Ice Menthol GEL TOPICAL 20100501 OTC MONOGRAPH FINAL part341 AMAR REMEDIES LIMITED MENTHOL 2.5 g/100g 41499-124_db5a0d57-fdd3-4404-934c-fcc80ea2ccda 41499-124 HUMAN OTC DRUG Amar Petroleum with Aloe Vera Petrolatum JELLY TOPICAL 20110701 OTC MONOGRAPH FINAL part347 Amar Remedies Limited PETROLATUM 99.8 g/100g 41499-125_d6f52cbe-b2e0-45ff-b44e-82e401777160 41499-125 HUMAN OTC DRUG Amar Petroleum Cocoa Butter Scented Petrolatum JELLY TOPICAL 20110701 OTC MONOGRAPH FINAL part347 Amar Remedies Limited PETROLATUM 99.8 g/100g 41520-001_4d3bced1-2a59-4fa8-9105-3a59a23baa9d 41520-001 HUMAN OTC DRUG Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20090803 OTC MONOGRAPH FINAL part347 American Sales Company LANOLIN; PETROLATUM 133; 459 mg/g; mg/g 41520-002_9ebb7596-ac6e-4377-af6e-738f656f9131 41520-002 HUMAN OTC DRUG care one enema Saline ENEMA RECTAL 20100118 OTC MONOGRAPH NOT FINAL part334 American Sales Company SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 41520-003_6f8ffe57-59ea-4f6b-aceb-432e9fb8a62c 41520-003 HUMAN OTC DRUG Creamy Petroleum White petrolatum JELLY TOPICAL 20090129 OTC MONOGRAPH FINAL part347 American Sales PETROLATUM .3 mg/100g 41520-004_ea5d26ad-2bfd-4178-857d-ce6b243cd760 41520-004 HUMAN OTC DRUG careone hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141221 OTC MONOGRAPH FINAL part346 American Sales Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 41520-005_2c5c333d-e378-47ab-a24e-d0e119c99599 41520-005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 American Sales Company SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 41520-008_63bc97a1-ff59-4aa0-bae5-f4cc6d4f544b 41520-008 HUMAN OTC DRUG care one pain relief infants Acetaminophen SUSPENSION/ DROPS ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 80 mg/.8mL 41520-012_92e168fe-aa61-49a5-8aa0-2bf749c96a90 41520-012 HUMAN OTC DRUG Pain Relief ES Acetaminophen TABLET ORAL 20140610 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 500 mg/1 41520-013_82c768b4-b18a-49eb-afd5-766daa35720b 41520-013 HUMAN OTC DRUG CareOne Allergy and congestion relief Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120821 ANDA ANDA076050 American Sales Company LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 41520-014_14bbf582-8a8e-4d2b-ae75-9d346716213d 41520-014 HUMAN OTC DRUG Care One Cold Multi Symptom Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070626 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 41520-016_7e943bcb-5e84-45eb-bcc7-d6b75afeea79 41520-016 HUMAN OTC DRUG CAREONE Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B American Sales Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 41520-018_78734dd4-3206-4d36-aeeb-8a5c4b481013 41520-018 HUMAN OTC DRUG Tussin DM Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20090603 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 41520-019_3aa06c06-a763-4c78-9f47-62d7b95dbbcf 41520-019 HUMAN OTC DRUG Gentle Laxative Stimulant Laxative Bisacodyl TABLET, COATED ORAL 20100930 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) BISACODYL 5 mg/1 41520-022_efd6b625-f947-4e6c-867f-a4a21b2bd9b8 41520-022 HUMAN OTC DRUG Stool Softener and Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20130301 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 41520-025_960fd57b-8c75-4d37-bd67-bc017f70844c 41520-025 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20090829 OTC MONOGRAPH FINAL part341 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 41520-027_da0eb90a-2486-451b-8f85-75a1a82efc4f 41520-027 HUMAN OTC DRUG care one allergy eye Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20100830 ANDA ANDA077958 American Sales Company KETOTIFEN FUMARATE .25 mg/mL 41520-030_76e85fb8-596c-442d-b904-a55ea94a6e16 41520-030 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20140630 OTC MONOGRAPH NOT FINAL part343 Care One (American Sales Company) ASPIRIN 81 mg/1 41520-036_7843ba5f-7ced-40d5-a31e-c2f9db4a301d 41520-036 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL 41520-037_a4ccad36-f6d5-44f4-b783-4b4d5a4884d6 41520-037 HUMAN OTC DRUG Mucus Relief Maximum Strength Severe Congestion and Cough dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL 41520-041_8cd83f69-938e-4fc3-80cc-774db5287d93 41520-041 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20101214 OTC MONOGRAPH FINAL part333D Foodhold SALICYLIC ACID 19.8 mg/g 41520-046_b3fcdd00-c746-470d-b4c4-52764d8f647d 41520-046 HUMAN OTC DRUG care one pain relief Acetaminophen TABLET, COATED ORAL 20090811 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 500 mg/1 41520-047_b093bb80-081d-4bdf-95be-3b751422846f 41520-047 HUMAN OTC DRUG care one acid reducer Ranitidine TABLET ORAL 20080213 ANDA ANDA078653 American Sales Company RANITIDINE HYDROCHLORIDE 150 mg/1 41520-049_e376e002-c66b-4941-bb8b-23325116f3f8 41520-049 HUMAN OTC DRUG Care One Pain Relief Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20080801 OTC MONOGRAPH NOT FINAL part348 American Sales Company CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g 41520-050_b6decf21-22a4-4370-a680-e713471b9718 41520-050 HUMAN OTC DRUG Care One Ibuprofen PM diphenhydramine citrate and ibuprofen TABLET, COATED ORAL 20090220 ANDA ANDA079113 American Sales Company DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 41520-051_7506564a-b9fc-4c6b-abdf-8ff8a085d38a 41520-051 HUMAN OTC DRUG Drowz Away Maximum strength Caffeine TABLET ORAL 20140305 OTC MONOGRAPH FINAL part340 Care One (American Sales Company) CAFFEINE 200 mg/1 41520-052_20fd7721-4e7f-4a25-954e-66c91cc4a1d5 41520-052 HUMAN OTC DRUG CareOne Nighttime Sleep Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140128 OTC MONOGRAPH FINAL part338 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41520-054_28cb9586-c10d-498b-a8f8-4bc223a87c2f 41520-054 HUMAN OTC DRUG careone suphedrine 12 hour relief non drowsy Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20040511 ANDA ANDA075153 American Sales Company PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 41520-057_85d7852d-d08c-4455-a776-7a14930caef1 41520-057 HUMAN OTC DRUG care one ibuprofen infants ibuprofen SUSPENSION ORAL 20040511 ANDA ANDA075217 American Sales Company IBUPROFEN 50 mg/1.25mL 41520-060_b530651b-a612-44b8-9929-d93994e3d86f 41520-060 HUMAN OTC DRUG Minral Oil Mineral Oil OIL ORAL; TOPICAL 20090416 OTC MONOGRAPH NOT FINAL part334 American Sales Company MINERAL OIL 15 mL/15mL 41520-061_a82766e1-af46-4973-a60f-2c96313c8580 41520-061 HUMAN OTC DRUG CareOne Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL 41520-065_949538e3-871f-4107-87de-02dff42abbbf 41520-065 HUMAN OTC DRUG care one nasal extra moisturizing Oxymetazoline HCl SPRAY NASAL 20040601 OTC MONOGRAPH FINAL part341 American Sales Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 41520-069_25fe00ae-7341-4c56-aadd-2ab668ed9fb3 41520-069 HUMAN OTC DRUG Petrolatum White Petrolatum JELLY TOPICAL 19920715 OTC MONOGRAPH FINAL part347 Foodhold USA, LLC PETROLATUM 1 g/g 41520-072_50185657-0694-4e2f-ab73-971d1af11467 41520-072 HUMAN OTC DRUG Night Time Cough Cherry DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20090908 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 135 mg/15mL; mg/5mL 41520-074_7819db1e-41cd-4b24-bfb9-c6285fddce92 41520-074 HUMAN OTC DRUG care one ibuprofen ib Ibuprofen TABLET, COATED ORAL 20060509 ANDA ANDA077349 American Sales Company IBUPROFEN 200 mg/1 41520-075_7711150b-8e6f-447d-9258-7df2ae4b65c8 41520-075 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141031 NDA NDA021920 Care One (American Sales Company) NAPROXEN SODIUM 220 mg/1 41520-076_eb308349-f997-4748-808d-2cdd0edec392 41520-076 HUMAN OTC DRUG CAREONE Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B American Sales Company NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g 41520-078_946d9593-9487-48f6-9b88-3403453673a0 41520-078 HUMAN OTC DRUG Milk of Magnesia Original MAGNESIUM HYDROXIDE SUSPENSION ORAL 20090402 OTC MONOGRAPH FINAL part334 American Sales Company MAGNESIUM HYDROXIDE 1200 mg/15mL 41520-079_74d3ff13-7dde-4349-8959-89f23bd0cfe3 41520-079 HUMAN OTC DRUG CAREONE INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E ETHYL ALCOHOL LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 700 mg/mL 41520-080_0fa5f25a-5ea8-4039-8716-8cfce68987d1 41520-080 HUMAN OTC DRUG Antifungal Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 American Sales Company TERBINAFINE HYDROCHLORIDE 1 g/100g 41520-081_451c7f45-8032-4839-b113-259f5a5ce7dd 41520-081 HUMAN OTC DRUG Milk of Magnesia Mint MAGNESIUM HYDROXIDE SUSPENSION ORAL 20090312 OTC MONOGRAPH FINAL part334 American Sales Company MAGNESIUM HYDROXIDE 1200 mg/15mL 41520-083_519784c5-f531-40d8-9936-5facc9660b2a 41520-083 HUMAN OTC DRUG care one ibuprofen cold and sinus Ibuprofen, Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20040511 ANDA ANDA074567 American Sales Company IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 41520-085_c09b23f3-4ca7-44fd-aec5-7cf6e5f4253b 41520-085 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 American Sales Company LORATADINE 5 mg/5mL 41520-092_e823d719-dac1-4b49-aed1-b1d6201158cc 41520-092 HUMAN OTC DRUG Care One Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 American Sales Company LORATADINE 5 mg/5mL 41520-093_e1e4e99a-a1fd-492d-aabc-d9f7813d22bc 41520-093 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20120520 OTC MONOGRAPH NOT FINAL part343 Care One (American Sales Company) ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 41520-094_31af8713-b652-4773-a320-a6af360915fb 41520-094 HUMAN OTC DRUG care one nasal decongestant pe maximum strength non drowsy Phenylephrine Hydrochloride TABLET ORAL 20050517 OTC MONOGRAPH FINAL part341 American Sales Company PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 41520-096_f2659925-80c8-411a-83b9-48fe24dfb9a5 41520-096 HUMAN OTC DRUG care one flu and severe cold and cough daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20120117 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 41520-098_c921b3c8-7e7e-4bc3-a95c-ab6bf6d141da 41520-098 HUMAN OTC DRUG Tussin Cough Long Acting DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20090821 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL 41520-099_3c3473b3-c4d6-424e-82cb-82ac344a30da 41520-099 HUMAN OTC DRUG Sinus Daytime Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20121114 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 41520-100_074a75f0-e886-4d9f-85ad-400e8153a151 41520-100 HUMAN OTC DRUG Tussin Sugar Free Cough Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20090210 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 41520-101_4ac278fe-fa8d-4d5c-88d4-632df32fa1fe 41520-101 HUMAN OTC DRUG Sinus Nighttime Acetaminophen, Doxylamine succinate and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20121031 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 41520-103_1c9f66ad-2cfb-45b9-a205-e8396666983a 41520-103 HUMAN OTC DRUG safety coated aspirin Aspirin TABLET ORAL 20100730 OTC MONOGRAPH NOT FINAL part343 Care One (American Sales Company) ASPIRIN 81 mg/1 41520-104_a09d2e9f-2a50-4daf-ac4b-25118aa69110 41520-104 HUMAN OTC DRUG CAREONE TAHITIAN COCONUT TRICLOSAN LIQUID TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL 41520-105_4c0b566a-25dc-4ae4-9cb8-cb992c1f5ff2 41520-105 HUMAN OTC DRUG Care One Pain Relief Childrens Acetaminophen SUSPENSION ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL 41520-106_02c27520-0f7b-46d1-8638-7d8fb15129d8 41520-106 HUMAN OTC DRUG CAREONE LIME BASIL TRICLOSAN LIQUID TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part333E AMERCIAN SALES COMPANY TRICLOSAN 4.6 mg/mL 41520-107_15148e63-976e-4eb4-835f-bdfb96036d44 41520-107 HUMAN OTC DRUG CAREONE VANILLA BROWN SUGAR TRICLOSAN LIQUID TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL 41520-110_1ed29fd2-8aba-46a9-bce9-31b792b62b0d 41520-110 HUMAN OTC DRUG CareOne Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061218 ANDA ANDA076779 American Sales Company NICOTINE 4 mg/1 41520-111_15eda702-b8ea-4d81-a08c-7ad548aa20dd 41520-111 HUMAN OTC DRUG Care One Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 American Sales POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 41520-112_773d074c-dde4-4f4c-ba61-b65cab9a12b4 41520-112 HUMAN OTC DRUG Night Time Original Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20100107 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 41520-113_b0895705-7579-4e4a-920c-caaf632f94b9 41520-113 HUMAN OTC DRUG Night Time Cherry Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, LIQUID ORAL 20090923 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 41520-114_883eaed8-4c55-4672-b814-e7715f60c3c1 41520-114 HUMAN OTC DRUG Night Time Cherry Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090908 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 41520-115_953120bc-5599-411c-9df1-51c3aed63e50 41520-115 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100720 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) DOCUSATE SODIUM 100 mg/1 41520-116_54a91980-4277-40b5-9333-2cd61effa823 41520-116 HUMAN OTC DRUG CARE ONE VANILLA BEAN TRICLOSAN LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL 41520-117_8b96d395-1038-4347-87e3-a82e83750bf5 41520-117 HUMAN OTC DRUG CareOne Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120524 ANDA ANDA202319 American Sales Company LANSOPRAZOLE 15 mg/1 41520-118_d2b5480d-facb-4267-b021-298f28d6199d 41520-118 HUMAN OTC DRUG CARE ONE PUMPKIN PIE TRICLOSAN LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL 41520-119_e51b56c4-83d8-4cfc-a33c-8961c1d8a4fd 41520-119 HUMAN OTC DRUG CARE ONE PEPPERMINT SWIRL TRICLOSAN LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL 41520-120_3c672f9c-c84c-46c3-a228-c62c37aeaeee 41520-120 HUMAN OTC DRUG gentle laxative for women stimulant laxative Bisacodyl TABLET ORAL 20100715 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) BISACODYL 5 mg/1 41520-121_4f445ea4-2128-42b9-8aec-a30ddeb1c198 41520-121 HUMAN OTC DRUG CARE ONE PINE TRICLOSAN LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL 41520-123_34cf9cca-c69f-4d0b-8c44-06945dbd3750 41520-123 HUMAN OTC DRUG CAREONE COUNTRY APPLE TRICLOSAN LIQUID TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL 41520-125_bee1996d-dcf7-4dde-a9c2-c2e80700c6ab 41520-125 HUMAN OTC DRUG CAREONE APPLE BERRY TRICLOSAN LIQUID TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL 41520-126_8ae220b6-3b84-4ca1-95fd-c2f81336ad8e 41520-126 HUMAN OTC DRUG Tussin CF DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20090826 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 41520-129_c832d2d1-0eca-4154-af03-98cfe242b8c7 41520-129 HUMAN OTC DRUG All Day Allergy Antihistamine Cetirizine HCl TABLET ORAL 20100907 ANDA ANDA078780 Care One (American Sales Company) CETIRIZINE HYDROCHLORIDE 10 mg/1 41520-130_94c63831-e01b-4bca-b7e8-2922a93e8b3c 41520-130 HUMAN OTC DRUG care one pain relief childrens Acetaminophen SUSPENSION ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL 41520-133_f9bbcb02-1cc0-4980-bef9-02758190ce9f 41520-133 HUMAN OTC DRUG care one flu and sore throat acetaminophen,pheniramine maleate, phenylephrine hydrochloride POWDER, FOR SUSPENSION ORAL 20101228 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/15000mg; mg/15000mg; mg/15000mg 41520-136_75d796b5-d98e-4432-9d6b-76eba68f0c8e 41520-136 HUMAN OTC DRUG Stomach Relief Cherry Pepto Bismol Cherry SUSPENSION ORAL 20131119 OTC MONOGRAPH FINAL part335 Care One BISMUTH SUBSALICYLATE 262 mg/15mL 41520-139_45144782-1d54-486d-b19e-148b09e99a28 41520-139 HUMAN OTC DRUG Care One Cold and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20060921 OTC MONOGRAPH FINAL part341 American Sales Company CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 41520-140_c41cafb1-8f08-484d-be75-e7f2bbc5ccd2 41520-140 HUMAN OTC DRUG care one all day pain relief Naproxen sodium TABLET, FILM COATED ORAL 20080926 ANDA ANDA074661 American Sales Company NAPROXEN SODIUM 220 mg/1 41520-141_11d463af-fb95-470a-a57c-87004189954b 41520-141 HUMAN OTC DRUG care one acid reducer original strength Famotidine TABLET ORAL 20091009 ANDA ANDA075400 American Sales Company FAMOTIDINE 10 mg/1 41520-142_c1c6ffd2-d811-4874-9143-4970ac17f595 41520-142 HUMAN OTC DRUG Laxative pills maximum strength Sennosides TABLET ORAL 20100805 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) SENNOSIDES 25 mg/1 41520-143_c6376a12-2f8d-411b-9728-e699fe87f2f6 41520-143 HUMAN OTC DRUG CareOne Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20110211 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL 41520-145_2c423433-ec38-4b37-8fb7-b583bf939550 41520-145 HUMAN OTC DRUG CareOne Mucus Relief Cold and Sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130823 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 41520-153_54f62564-ffed-4f59-8ea0-178687adb06a 41520-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H American Sales Company PYRITHIONE ZINC 1 kg/100L 41520-154_84c43793-98e4-4e68-a3bc-3e7222135568 41520-154 HUMAN OTC DRUG CareOne Miconazole 3 Miconazole nitrate KIT 20140413 ANDA ANDA075329 American Sales Company 41520-155_0ce7ec52-263b-49a6-934b-71c850728da0 41520-155 HUMAN OTC DRUG Flu Relief Therapy Day Time Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20090908 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 41520-160_68413266-83fd-4960-9380-10280c9afd44 41520-160 HUMAN OTC DRUG CareOne Hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20130102 OTC MONOGRAPH FINAL part346 American Sales Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g 41520-161_1dea76ff-ad67-481b-af80-3a2d70836fde 41520-161 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110516 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .46 mL/100mL 41520-163_c46e2004-2fba-4fe4-915b-47490463e621 41520-163 HUMAN OTC DRUG Anticavity Sodium Fluoride MOUTHWASH ORAL 20050912 OTC MONOGRAPH FINAL part355 American Sales Company SODIUM FLUORIDE 1 mg/mL 41520-165_65605c3c-749a-48fd-a7a8-262f45b64141 41520-165 HUMAN OTC DRUG ANTIBACTERIAL FOAMING GREEN TEA TRICLOSAN LIQUID TOPICAL 20110516 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .46 mL/100mL 41520-166_f3938282-dcd1-433f-ad74-87cab8b32409 41520-166 HUMAN OTC DRUG care one ibuprofen childrens Ibuprofen SUSPENSION ORAL 20040428 ANDA ANDA074937 American Sales Company IBUPROFEN 100 mg/5mL 41520-167_a25acb68-7365-456b-b517-a6745fa64768 41520-167 HUMAN OTC DRUG ANTIBACTERIAL FOAMING HAND SP CUCUMBER AND MELON TRICLOSAN LIQUID TOPICAL 20110524 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .6 mL/100mL 41520-168_d59294c7-2de7-4a2c-819e-f1e0fccf3eb0 41520-168 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111006 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .6 mL/100mL 41520-169_1af8d91e-b018-466d-86d1-8d19670be829 41520-169 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110516 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .46 mL/100mL 41520-170_b0d260e6-b973-4fb5-825f-75f28e0ff93f 41520-170 HUMAN OTC DRUG ANTIBACTERIAL FOAMING OLIVE AND ALOE TRICLOSAN LIQUID TOPICAL 20110121 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .3 mL/100mL 41520-170_b6f080b6-4f77-4067-8da1-97bfee9a901e 41520-170 HUMAN OTC DRUG ANTIBACTERIAL FOAMING OLIVE AND ALOE TRICLOSAN LIQUID TOPICAL 20111025 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .3 mL/100mL 41520-171_a57be6d4-8a5e-4f92-8758-7e2a9522d3f8 41520-171 HUMAN OTC DRUG ANTIBACTERIAL FOAMING BERRY MEDLEY TRICLOSAN LIQUID TOPICAL 20110121 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .3 mL/100mL 41520-172_897f99da-7773-4931-ab00-433de4d9fd25 41520-172 HUMAN OTC DRUG ANTIBACTERIAL FOAMING HAND SP LEMONGRASS TRICLOSAN LIQUID TOPICAL 20110524 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES TRICLOSAN .6 mL/100mL 41520-173_aff4c53b-24bd-4b2d-8f47-75a048383e11 41520-173 HUMAN OTC DRUG careone lice Piperonyl Butoxide, Pyrethrum Extract KIT 20070926 OTC MONOGRAPH FINAL part358G American Sales Company 41520-173_f0ac01e5-4bd8-4c7c-9e15-9b7addd8e407 41520-173 HUMAN OTC DRUG careone lice Piperonyl Butoxide, Pyrethrum Extract KIT 20070926 OTC MONOGRAPH FINAL part358G American Sales Company 41520-175_56eb4917-74dd-4ea3-872b-fd546a914392 41520-175 HUMAN OTC DRUG care one pain relief childrens Acetaminophen SUSPENSION ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL 41520-176_61796249-388c-47c7-85a9-e94281b7948b 41520-176 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140630 OTC MONOGRAPH NOT FINAL part356 Care One (American Sales Company) PHENOL 1.4 g/100mL 41520-178_47d2da7d-230b-413c-8267-8408cdc6a95d 41520-178 HUMAN OTC DRUG CAREONE INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 700 mg/mL 41520-179_b3d9bae4-da40-4217-833a-8f8d111514fb 41520-179 HUMAN OTC DRUG care one calcium antacid Calcium carbonate TABLET, CHEWABLE ORAL 20040301 OTC MONOGRAPH FINAL part331 American Sales Company CALCIUM CARBONATE 750 mg/1 41520-180_285855f8-d1f8-485a-b360-faa586015537 41520-180 HUMAN OTC DRUG Senna laxative Natural vegetable laxative SENNOSIDES TABLET ORAL 20130220 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) SENNOSIDES 8.6 mg/1 41520-182_6629cc4f-13d7-4926-8bad-a06d8c06b7a6 41520-182 HUMAN OTC DRUG Senna S docusate sodium and sennosides TABLET ORAL 20100715 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 41520-183_29223c42-bc35-4633-a212-d53d773dfa02 41520-183 HUMAN OTC DRUG ANTIBACTERIAL FOAMING HAND SP CHERRY AND ALMOND TRICLOSAN LIQUID TOPICAL 20110524 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES TRICLOSAN .6 mL/100mL 41520-187_227f52d0-b44e-4969-8f77-4c0fc14be1b1 41520-187 HUMAN OTC DRUG Care One pain relief extra strength Acetaminophen TABLET, COATED ORAL 20031125 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 500 mg/1 41520-188_46794d2e-8fe6-490d-9cfa-ba9b6c209ad6 41520-188 HUMAN OTC DRUG careone hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140720 OTC MONOGRAPH FINAL part346 American Sales Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 41520-189_975ecee8-52cd-4a3c-a304-8be3a3d24c80 41520-189 HUMAN OTC DRUG CareOne Childrens All Day Allergy Cetirizine HCl LIQUID ORAL 20131227 ANDA ANDA204226 American Sales Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 41520-190_ca40d723-dbc2-4b81-b176-03f1e6f15333 41520-190 HUMAN OTC DRUG CARE ONE ANTIBACTERIAL RUM RAISIN TRICLOSAN LIQUID TOPICAL 20120927 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 3 mg/mL 41520-191_58455c76-6876-4299-82d7-1f859ad77b84 41520-191 HUMAN OTC DRUG CARE ONE ANTIBACTERIAL TANGERINE SPICE TRICLOSAN LIQUID TOPICAL 20120927 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 3 mg/mL 41520-192_b4e3c65d-3b02-4099-b0aa-17ab18104bd9 41520-192 HUMAN OTC DRUG CARE ONE ANTIBACTERIAL SNOW KISSED PEAR TRICLOSAN LIQUID TOPICAL 20120927 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 3 mg/mL 41520-193_23c03d48-9b68-4a1e-bc3b-8229dd2f5d00 41520-193 HUMAN OTC DRUG CARE ONE ANTIBACTERIAL PEPPERMINT SWIRL TRICLOSAN LIQUID TOPICAL 20120927 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 3 mg/mL 41520-195_4e911e88-175c-4f09-a12c-3dc401bd0400 41520-195 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130315 ANDA ANDA078682 Care One (American Sales Company) IBUPROFEN 200 mg/1 41520-196_3db799d5-7bcb-4df9-9c02-957d9bc90591 41520-196 HUMAN OTC DRUG CARE ONE CREAMY COCONUT TRICLOSAN LIQUID TOPICAL 20130220 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL 41520-197_fc1335ea-8a88-4ffb-bac4-9be715b3804c 41520-197 HUMAN OTC DRUG CARE ONE SUN KISSED PEAR TRICLOSAN LIQUID TOPICAL 20130220 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL 41520-198_c2cd2e41-2c13-4866-b710-c454b6b784e6 41520-198 HUMAN OTC DRUG CARE ONE VANILLA APPLE BLOSSOM TRICLOSAN LIQUID TOPICAL 20130220 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL 41520-199_0af3dcc2-dbef-4aa2-9298-c90da146dd42 41520-199 HUMAN OTC DRUG CARE ONE LEMON VERBENA TRICLOSAN LIQUID TOPICAL 20130220 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL 41520-201_d3c495fe-e59b-42f6-b986-dee266ae3c18 41520-201 HUMAN OTC DRUG 1 hydrocortisone maximum strength hydrocortisone OINTMENT TOPICAL 20121017 OTC MONOGRAPH NOT FINAL part348 American Sales Company HYDROCORTISONE 1 g/100g 41520-205_00a5f004-03db-4d53-b63b-cf00d107becc 41520-205 HUMAN OTC DRUG Therapeutic Plus Coal Tar SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H FoodHold U.S.A., LLC COAL TAR 25 mg/mL 41520-206_9c3033fc-6ae0-4119-a6ef-0d732f3e33a5 41520-206 HUMAN OTC DRUG Care One Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050208 ANDA ANDA078325 American Sales Company NICOTINE 2 mg/1 41520-207_4050612d-7765-44e7-82e8-55470d6f653b 41520-207 HUMAN OTC DRUG CareOne Pain Relief Acetaminophen LIQUID ORAL 20110902 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL 41520-210_ca6269c5-59dd-492d-9df3-e2296b855ceb 41520-210 HUMAN OTC DRUG Antiseptic Mouth rinse Eucalyptol MOUTHWASH ORAL 20100802 OTC MONOGRAPH NOT FINAL part348 American Sales Company EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 41520-211_b593030f-7c97-41ad-82e3-0a8f52614dc1 41520-211 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20131230 NDA NDA022429 Care One (American Sales Company) CETIRIZINE HYDROCHLORIDE 10 mg/1 41520-213_8dbbc90f-10cc-4f95-9d3d-ae49c48598ff 41520-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20100524 OTC MONOGRAPH FINAL part355 American Sales Company SODIUM FLUORIDE .05 kg/100L 41520-214_35cc9dec-3ff1-49d4-be58-bd69da9e6cb2 41520-214 HUMAN OTC DRUG care one miconazole 7 Miconazole nitrate CREAM VAGINAL 19991011 ANDA ANDA074760 American Sales Company MICONAZOLE NITRATE 2 g/100g 41520-217_84c55280-f87a-4434-9082-b6fa7c8051c5 41520-217 HUMAN OTC DRUG care one pain relief 8 hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051129 ANDA ANDA075077 American Sales Company ACETAMINOPHEN 650 mg/1 41520-220_a1718e1a-a066-47fd-b6db-d400f5dc9a6b 41520-220 HUMAN OTC DRUG CAREONE ETHYL ALCOHOL LIQUID TOPICAL 20130606 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 620 mg/mL 41520-223_1cc5e2f7-1f6e-4ecb-a7ff-d1a7467bc7a8 41520-223 HUMAN OTC DRUG CAREONE INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20110114 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 62 mL/100mL 41520-223_24f0f587-3a19-4f45-8357-06daca4ef3db 41520-223 HUMAN OTC DRUG CAREONE INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20110708 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 62 mL/100mL 41520-224_639f7cc2-9fe4-43c3-a2bb-04bb528d74af 41520-224 HUMAN OTC DRUG Care One anti diarrheal loperamide hydrochloride Loperamide Hydrochloride TABLET, FILM COATED ORAL 20040123 ANDA ANDA075232 American Sales Company LOPERAMIDE HYDROCHLORIDE 2 mg/1 41520-225_99db10f5-33ec-4b42-a450-7764118a8a3a 41520-225 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 62 mL/100mL 41520-226_88584132-b3e6-4e14-a1ca-0a3fc4cd0fa9 41520-226 HUMAN OTC DRUG Creamy Diaper Rash Zinc Oxide OINTMENT TOPICAL 20110901 OTC MONOGRAPH FINAL part347 American Sales ZINC OXIDE 13 kg/100kg 41520-227_a51f78fc-c6dc-43bd-b963-5e62533acbe7 41520-227 HUMAN OTC DRUG CAREONE INSTANT HAND SANITIZER LEMON ETHYL ALCOHOL GEL TOPICAL 20110114 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 62 mL/100mL 41520-227_ed486ffb-3bfd-416c-8ae8-c5b52b3407fe 41520-227 HUMAN OTC DRUG Care One Pain Relief Acetaminophen TABLET, COATED ORAL 20060502 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 500 mg/1 41520-228_6e9b2fe8-6681-45b0-8ce1-cfaffd2f7dfa 41520-228 HUMAN OTC DRUG Aspirin Enteric Safety Coated Aspirin TABLET ORAL 20140430 OTC MONOGRAPH FINAL part343 Care One (American Sales Company) ASPIRIN 81 mg/1 41520-230_ecc5a12f-507c-4141-af1b-11ad9c6d4211 41520-230 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20111005 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 62 mL/100mL 41520-231_a4f98a63-62b8-4b27-a9d6-5bbfbb80d611 41520-231 HUMAN OTC DRUG Sleep Aid maximum strength Diphenhydramine HCl CAPSULE ORAL 20100701 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 41520-234_85e22ae3-53dd-405a-92a5-93b35cd4458c 41520-234 HUMAN OTC DRUG Care One cold head congestion Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20081024 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 41520-235_a4035454-bf60-471d-b580-68071fc3bb5c 41520-235 HUMAN OTC DRUG SANITIZER HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20110506 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES ALCOHOL 62 mL/100mL 41520-236_ea286cc9-1013-4d81-b8ca-04d77839c70a 41520-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 41520-238_f268f4d4-ae94-4b55-8945-738161175403 41520-238 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130708 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) DOCUSATE SODIUM 100 mg/1 41520-240_36893d28-9257-46f2-aa6d-7ea6ce3e324c 41520-240 HUMAN OTC DRUG FOAMING HAND SANITIZER WITH ALOE BENZALKONIUM CHLORIDE GEL TOPICAL 20111006 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY BENZALKONIUM CHLORIDE .1 mL/100mL 41520-241_286c994c-9d23-458a-933d-5d1bf760842a 41520-241 HUMAN OTC DRUG CAREONE ANTIMICROBIAL FOAMING HAND SP FALLING RAIN BENZETHONIUM CHLORIDE LIQUID TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY BENZETHONIUM CHLORIDE .1 mL/100mL 41520-242_599b8a3a-c320-46a3-9590-7317652f4fc0 41520-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131115 OTC MONOGRAPH FINAL part347 Care One (American Sales Company) DIMETHICONE 125 mg/1 41520-244_a54501f8-1af4-4343-a279-a611089366b4 41520-244 HUMAN OTC DRUG Stool Softener Gentle Relief DOCUSATE SODIUM CAPSULE ORAL 20131230 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) DOCUSATE SODIUM 100 mg/1 41520-250_2d1a1a77-945e-4bd8-b357-1320bf1a8738 41520-250 HUMAN OTC DRUG care one cold multi symptom Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20081010 OTC MONOGRAPH FINAL part341 American Sales Company 41520-251_a20ecd32-cc14-4ee3-8491-29d5a4392b53 41520-251 HUMAN OTC DRUG care one analgesic Trolamine Salicylate CREAM TOPICAL 20080603 OTC MONOGRAPH NOT FINAL part348 American Sales Company TROLAMINE SALICYLATE 10 g/100g 41520-252_d761ce3e-5a9d-43ef-ad95-b1a3d8326c5c 41520-252 HUMAN OTC DRUG Drowz Away Maximum strength Caffeine TABLET ORAL 20100831 OTC MONOGRAPH FINAL part340 Care One (American Sales Company) CAFFEINE 200 mg/1 41520-255_15f63d40-276c-4c02-9f8c-0354e4779916 41520-255 HUMAN OTC DRUG care one ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20060516 ANDA ANDA075217 American Sales Company IBUPROFEN 50 mg/1.25mL 41520-259_9da3ed9b-bcea-4b31-a766-204837c3a7bd 41520-259 HUMAN OTC DRUG care one aspirin Aspirin TABLET, CHEWABLE ORAL 20051122 OTC MONOGRAPH NOT FINAL part343 American Sales Company ASPIRIN 81 mg/1 41520-270_ba3e9c30-28b9-4604-8af8-00d1f2eed873 41520-270 HUMAN OTC DRUG Sinus Headache PE Maximum Strenght Non- Drowsy Acetaminophen and Phenylephrine HCl TABLET ORAL 20140612 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 41520-271_674e7d80-71a7-401e-97d9-761fddea2aef 41520-271 HUMAN OTC DRUG Careone Acid Reducer Ranitidine TABLET ORAL 20090529 ANDA ANDA076760 American Sales Company RANITIDINE HYDROCHLORIDE 75 mg/1 41520-272_2516654f-5534-4017-81c5-cc5ba5c5b6b7 41520-272 HUMAN OTC DRUG care one sinus congestion and pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20070207 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 41520-279_aa788c6c-481d-478c-8216-45a7ad7b8147 41520-279 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part333A Foodhold U.S.A. BENZALKONIUM CHLORIDE 1.3 g/mL 41520-280_d5c6ed63-74af-4354-a64a-ea6d883a6ac3 41520-280 HUMAN OTC DRUG HAND SANITIZER BENZALKONIUM CHLORIDE GEL TOPICAL 20111006 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY BENZALKONIUM CHLORIDE .1 mL/100mL 41520-281_5bb51652-ea78-4727-91c3-2e94e7cc4abe 41520-281 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110622 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .15 mL/100mL 41520-282_bc2f5094-0d8b-43a0-aae7-713651df52b1 41520-282 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110622 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .15 mL/100mL 41520-283_cdc6cd57-b88d-43d4-a1b2-640c109e694b 41520-283 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110622 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .15 mL/100mL 41520-288_6243d377-7a15-48ec-b7d3-32a8c9114e7b 41520-288 HUMAN OTC DRUG careone mucus relief childrens Guaifenesin LIQUID ORAL 20070808 OTC MONOGRAPH FINAL part341 American Sales Company GUAIFENESIN 100 mg/5mL 41520-289_b030dd91-fc63-4519-b10d-0a0b86cd067e 41520-289 HUMAN OTC DRUG care one pain relief infants Acetaminophen SUSPENSION/ DROPS ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 80 mg/.8mL 41520-293_084b5ccb-cd0b-4afe-937f-609808367609 41520-293 HUMAN OTC DRUG ANTIBACTERIAL MANDARIN AND POMELO TRICLOSAN LIQUID TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .15 mL/100mL 41520-294_f4ba4490-4c67-4892-8a12-be2dd8860431 41520-294 HUMAN OTC DRUG careone hair regrowth treatment Minoxidil AEROSOL, FOAM TOPICAL 20120727 ANDA ANDA091344 American Sales Company MINOXIDIL 5 g/100g 41520-295_3ac60220-ce34-4361-9dab-10a05af5b38f 41520-295 HUMAN OTC DRUG Itch Relief Diphenhydramine HCl, Zinc Acetate SPRAY TOPICAL 20111006 OTC MONOGRAPH NOT FINAL part348 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 kg/100L; kg/100L 41520-296_16fdc6f9-4ea8-4df3-9ebf-4862a015b654 41520-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20090605 OTC MONOGRAPH FINAL part358H American Sales Company PYRITHIONE ZINC 1 kg/100L 41520-300_787ea330-eb37-4843-bece-c1ce47ece2d7 41520-300 HUMAN OTC DRUG CareOne Pain Relief Acetaminophen TABLET, FILM COATED ORAL 20060502 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 500 mg/1 41520-302_fd2dd91a-8204-4098-b37b-9c3b1903e983 41520-302 HUMAN OTC DRUG careone stomach relief Bismuth subsalicylate SUSPENSION ORAL 20120805 OTC MONOGRAPH FINAL part335 American Sales Company BISMUTH SUBSALICYLATE 525 mg/30mL 41520-304_34605e0e-b6f3-459b-9921-b0ca1d90463c 41520-304 HUMAN OTC DRUG care one nasal original oxymetazoline hydrochloride SPRAY NASAL 20040524 OTC MONOGRAPH FINAL part341 American Sales Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 41520-305_9e0e3507-73d5-4f52-bd31-6f2448102d26 41520-305 HUMAN OTC DRUG CAREONE Clotrimazole Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C American Sales Company CLOTRIMAZOLE 10 mg/g 41520-306_df5e13b3-82ca-456f-89d4-288d3b69fb6c 41520-306 HUMAN OTC DRUG care one clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091009 ANDA ANDA090685 American Sales Company POLYETHYLENE GLYCOL 3350 17 g/17g 41520-309_0d13a818-a8c2-4387-9849-274f3180b775 41520-309 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20110210 OTC MONOGRAPH FINAL part358H American Sales Company PYRITHIONE ZINC 1 g/100mL 41520-310_7e4b06a2-2590-49e1-b0cb-e5f4bb7306bd 41520-310 HUMAN OTC DRUG CareOne Adult Tussin Guaifenesin SYRUP ORAL 20040504 OTC MONOGRAPH FINAL part341 American Sales Company GUAIFENESIN 200 mg/10mL 41520-311_e0c1af02-6dbf-4d10-844b-3a388301343f 41520-311 HUMAN OTC DRUG Dandruff Pyrithione zinc LOTION/SHAMPOO TOPICAL 20040709 OTC MONOGRAPH FINAL part358H American Sales Company PYRITHIONE ZINC 1 g/100mL 41520-312_70852bab-eae3-4234-aec9-20cb600d2c0c 41520-312 HUMAN OTC DRUG Careone Original Strength Triple Antibiotic Bacitracin Neomycin Polymyxin B OINTMENT TOPICAL 20140916 OTC MONOGRAPH FINAL part333B Foodhold U.S.A. LLC BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 50000 [iU]/g; mg/g; [iU]/g 41520-313_0f14aa75-5c61-4e9e-8c01-9ddb132612bc 41520-313 HUMAN OTC DRUG CAREONE BACITRACIN BACITRACIN OINTMENT TOPICAL 20120301 OTC MONOGRAPH FINAL part333B AMERICAN SALES COMPANY BACITRACIN 500 [USP'U]/g 41520-314_03a904e7-32e6-4cf7-9c69-9b61b86e93f0 41520-314 HUMAN OTC DRUG CAREONE ALLERGY DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 AMERICAN SALES COMPANY DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 41520-315_73ad1b27-2122-4270-8e39-dae0475ded17 41520-315 HUMAN OTC DRUG Care One Maximum Strength First Aid Antibiotic Neomycin Sulfate Polymyxin B Sulfate Pramoxine Hydrochloride CREAM TOPICAL 20140908 OTC MONOGRAPH FINAL part333B Foodhold U.S.A. LLC NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP&apos'U]/g; mg/g 41520-318_227c35b3-485e-47e9-89f7-d4d0bf7b0d24 41520-318 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 19890313 OTC MONOGRAPH NOT FINAL part356 American Sales Company EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 41520-319_54b8cd41-5a36-43cb-86da-7573073cca41 41520-319 HUMAN OTC DRUG Care One hydrocortisone maximum strength Hydrocortisone CREAM TOPICAL 20100528 OTC MONOGRAPH NOT FINAL part348 American Sales Company HYDROCORTISONE 1 g/100g 41520-321_52107212-7232-4349-8481-7711bb200c3d 41520-321 HUMAN OTC DRUG Care One Acid Reducer plus Antacid Dual Action Famotidine, Calcium Carbonate,Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080801 ANDA ANDA077355 American Sales Company CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 41520-323_161c0726-6d59-4563-9106-a705ea68f8f4 41520-323 HUMAN OTC DRUG CareOne Lubricant Eye Plus carboxymethylcellulose sodium SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130620 OTC MONOGRAPH FINAL part349 American Sales Company CARBOXYMETHYLCELLULOSE SODIUM .5 g/100mL 41520-328_3d6e2960-5484-4323-9498-a8456378c059 41520-328 HUMAN OTC DRUG care one sore throat Phenol SPRAY ORAL 20031119 OTC MONOGRAPH NOT FINAL part356 American Sales Company PHENOL 1.4 g/100mL 41520-330_c261706c-37ef-4d7e-99c0-6b285675c7b7 41520-330 HUMAN OTC DRUG CareOne Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20130731 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 41520-332_fa3fad85-e5da-4258-97bb-4e0be6d134ac 41520-332 HUMAN OTC DRUG careone milk of magnesia Magnesium hydroxide LIQUID ORAL 20120727 OTC MONOGRAPH NOT FINAL part334 American Sales Company MAGNESIUM HYDROXIDE 1200 mg/15mL 41520-333_220a48c3-2d87-4b82-8c41-caec5c77bc81 41520-333 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 American Sales Company ACETAMINOPHEN 650 mg/1 41520-335_911fdf0b-c30e-49e2-9311-8813dc2857a4 41520-335 HUMAN OTC DRUG CareOne Nitetime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20130813 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 41520-336_a833a491-7e96-4c0e-b534-38f757335f9e 41520-336 HUMAN OTC DRUG Acetaminophen-APAP 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 American Sales Company ACETAMINOPHEN 650 mg/1 41520-337_c9aaf8d7-d5f2-4e15-ad6b-fcbf67a3f721 41520-337 HUMAN OTC DRUG careone stomach relief Bismuth subsalicylate SUSPENSION ORAL 20120805 OTC MONOGRAPH FINAL part335 American Sales Company BISMUTH SUBSALICYLATE 1050 mg/30mL 41520-340_221825cd-4b71-4d97-ab9a-848552885f84 41520-340 HUMAN OTC DRUG careone liquid antacid aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 20120927 OTC MONOGRAPH FINAL part331 American Sales Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 41520-341_e5c46712-ee67-4760-84b4-818488718644 41520-341 HUMAN OTC DRUG COTTONTAILS DIAPER RASH LANOLIN, PETROLATUM PASTE TOPICAL 20131216 OTC MONOGRAPH FINAL part347 AMERICAN SALES COMPANY LANOLIN; PETROLATUM 155; 534 mg/g; mg/g 41520-343_d7d1e9e7-2bcc-4e74-9007-80d9fb3adee2 41520-343 HUMAN OTC DRUG COTTONTAILS DIAPER RASH ZINC OXIDE OINTMENT TOPICAL 20120501 OTC MONOGRAPH FINAL part347 AMERICAN SALES ZINC OXIDE .4 g/g 41520-344_484c2d63-b12c-4477-9f75-661dde6ec559 41520-344 HUMAN OTC DRUG Anticavity Rinse Fluoride Rinse Anticavity Rinse MOUTHWASH ORAL 20090905 OTC MONOGRAPH FINAL part355 American Sales Company SODIUM FLUORIDE .0221 kg/100L 41520-345_58f559a8-ef00-4e1b-a0c9-84fc5b7d9ba9 41520-345 HUMAN OTC DRUG careone severe sinus congestion Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140830 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 41520-352_d1f2f3c3-33ee-4892-8902-80918c606daa 41520-352 HUMAN OTC DRUG care one nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20080829 ANDA ANDA078547 American Sales Company NICOTINE 2 mg/1 41520-357_d5ca9f59-d086-40ef-9aff-2f5de75afb6c 41520-357 HUMAN OTC DRUG careone antacid regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20121118 OTC MONOGRAPH FINAL part331 American Sales Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 41520-358_3ab6149e-1782-4e22-8f55-b581909cd2e2 41520-358 HUMAN OTC DRUG Care One Sinus and Allergy PE Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20061212 OTC MONOGRAPH FINAL part341 American Sales Company CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 41520-359_81046216-9fbd-45b5-8a10-3524cdedcd61 41520-359 HUMAN OTC DRUG CareOne Adult Tussin DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20040504 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 41520-361_0be2f9dc-674b-4982-89e8-23d16a12553f 41520-361 HUMAN OTC DRUG CareOne Allergy Medication Diphenhydramine Hydrochloride TABLET ORAL 20040524 OTC MONOGRAPH FINAL part341 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41520-365_942cf491-dc3d-49c2-ad83-1a579b7d3c2e 41520-365 HUMAN OTC DRUG careone nicotine polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20120922 ANDA ANDA091349 American Sales Company NICOTINE 2 mg/1 41520-368_9d588aa4-5175-4d23-9f6b-25703efef4d6 41520-368 HUMAN OTC DRUG care one all day pain relief Naproxen Sodium TABLET, FILM COATED ORAL 20040405 ANDA ANDA074661 American Sales Company NAPROXEN SODIUM 220 mg/1 41520-370_f703b665-db5c-472e-be55-2898976cc244 41520-370 HUMAN OTC DRUG aspirin Regular strength Aspirin TABLET, COATED ORAL 20110802 OTC MONOGRAPH FINAL part343 Care One (American Sales Company) ASPIRIN 325 mg/1 41520-371_02c3af37-c67a-4b16-b5db-a5dca8f7632e 41520-371 HUMAN OTC DRUG Care One Cold Multi Symptom Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070606 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 41520-374_b6f2fe57-f7a2-498e-b334-16753636887a 41520-374 HUMAN OTC DRUG Care One migraine relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20040413 ANDA ANDA075794 American Sales Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 41520-376_838b1884-d709-48a7-a3a0-241c9424e65f 41520-376 HUMAN OTC DRUG CareOne Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL 41520-377_2d19727a-9514-4f02-bc77-f7b42262d5c8 41520-377 HUMAN OTC DRUG Sore Throat Menthol Phenol SPRAY ORAL 20140501 OTC MONOGRAPH NOT FINAL part356 Care One (American Sales Company) PHENOL 1.4 g/100mL 41520-379_38a16a28-9baa-42a8-8d29-244662601e7c 41520-379 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20120110 OTC MONOGRAPH NOT FINAL part348 Foodhold U.S.A. LLC MENTHOL 1.5 mg/g 41520-381_fc39458f-5e32-4e8f-bdd8-d54a2702b725 41520-381 HUMAN OTC DRUG CareOne Mucus Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130823 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 41520-384_2543912b-e6dd-46ca-8f0e-12603f6c28a7 41520-384 HUMAN OTC DRUG CareOne Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120830 ANDA ANDA091135 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 41520-388_61cd15f7-ef27-40c3-af66-feda97b34465 41520-388 HUMAN OTC DRUG care one nasal Oxymetazoline HCl SPRAY NASAL 20040720 OTC MONOGRAPH FINAL part341 American Sales Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 41520-390_b45eb1ac-b3fa-464c-9b16-e2df7bcd0df1 41520-390 HUMAN OTC DRUG care one nose drops Phenylephrine hydrochloride LIQUID NASAL 20040601 OTC MONOGRAPH FINAL part341 American Sales Company PHENYLEPHRINE HYDROCHLORIDE 1 mL/100mL 41520-393_2ff5eb6b-2d04-401b-9f5c-bea8c87abaea 41520-393 HUMAN OTC DRUG Care One Cold Head Congestion Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070718 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 41520-394_5e090ef5-08bd-438f-8b02-f276b1a7bdd9 41520-394 HUMAN OTC DRUG Care One Hemorrhoidal Cocoa butter, Phenylephrine HCl, Shark liver oil SUPPOSITORY RECTAL 20031209 OTC MONOGRAPH FINAL part346 American Sales Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2137.5; 75; 6.375 mg/1; mg/1; mg/1 41520-396_dc1f5035-69bf-4604-b92c-7a85ca4b9928 41520-396 HUMAN OTC DRUG careone milk of magnesia Magnesium hydroxide LIQUID ORAL 20120805 OTC MONOGRAPH NOT FINAL part334 American Sales Company MAGNESIUM HYDROXIDE 1200 mg/15mL 41520-397_e4625ed7-bd74-4f79-a5b7-7b89616b3b12 41520-397 HUMAN OTC DRUG careone childrens pain and fever acetaminophen SUSPENSION ORAL 20120821 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL 41520-399_c5ff7c16-4502-44cd-889d-5f4fb10d6379 41520-399 HUMAN OTC DRUG careone infants pain relief acetaminophen SUSPENSION ORAL 20140327 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL 41520-400_adeb9c3c-1bde-4a82-828e-1ddab94304fa 41520-400 HUMAN OTC DRUG Care One Hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 20040316 OTC MONOGRAPH FINAL part346 American Sales Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 41520-401_8ec60879-f4d4-45f1-8239-013c709bd1ce 41520-401 HUMAN OTC DRUG CAREONE TAHITIAN COCONUT ETHYL ALCOHOL LIQUID TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-401_910f6d88-f1a6-422e-b2b8-7ad8bfc2ba1a 41520-401 HUMAN OTC DRUG CAREONE TAHITIAN COCONUT ETHYL ALCOHOL LIQUID TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-402_0654ab1f-3a2d-4847-b422-7fb397d38691 41520-402 HUMAN OTC DRUG Care One Cold Head Congestion daytime non-drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070531 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 41520-403_72dd82ea-abdc-4af6-bd80-eaaf9316d315 41520-403 HUMAN OTC DRUG care one pain relief Acetaminophen TABLET ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 325 mg/1 41520-404_567c9e15-d004-4153-a3c5-49d21b519388 41520-404 HUMAN OTC DRUG CareOne Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL 41520-407_4d1ca466-b6db-4257-ae97-8d2e67ac5a88 41520-407 HUMAN OTC DRUG CareOne Cold Sore Treatment Camphor CREAM TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part348 American Sales Company BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g 41520-410_3135acba-666a-4faa-8360-0644e15e687d 41520-410 HUMAN OTC DRUG CAREONE COUNTRY APPLE ETHYL ALCOHOL LIQUID TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-410_a5c0ca09-8eb0-456f-92c5-857b95553597 41520-410 HUMAN OTC DRUG CAREONE COUNTRY APPLE ETHYL ALCOHOL LIQUID TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-413_8bfbb5b5-67f5-4a87-a926-10f140353ab5 41520-413 HUMAN OTC DRUG careone ibuprofen pm Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20111208 ANDA ANDA079113 American Sales Company DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 41520-415_a4bf4237-b53b-41e9-b8d3-2e53360f05d7 41520-415 HUMAN OTC DRUG Care One Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 American Sales POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 41520-416_26300d2c-4a2a-46fa-8391-1213f635fc39 41520-416 HUMAN OTC DRUG Care One Aspirin Aspirin TABLET ORAL 20040518 OTC MONOGRAPH NOT FINAL part343 American Sales Company ASPIRIN 325 mg/1 41520-418_12b6b69b-0700-413b-aa7e-57858bab2b29 41520-418 HUMAN OTC DRUG Skin Corrective Innovative Skin Perfector BB Broad Spectrum SPF15 Sunscreen Light Medium Titanium Dioxide, Octinoxate CREAM TOPICAL 20131113 OTC MONOGRAPH NOT FINAL part352 American Sales Company OCTINOXATE; TITANIUM DIOXIDE 4; 2.1 g/100mL; g/100mL 41520-419_47d7a8bc-415e-40ca-988a-07c90def82dd 41520-419 HUMAN OTC DRUG careone childrens mucus relief Dextromethorphan hbr, Guaifenesin LIQUID ORAL 20070808 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 41520-422_38e9ef32-828f-42dc-b0b0-a02cc3716f72 41520-422 HUMAN OTC DRUG Care One Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050208 ANDA ANDA078326 American Sales Company NICOTINE 4 mg/1 41520-423_35bbb6a3-c3bd-4790-91f1-faa0fb759a3e 41520-423 HUMAN OTC DRUG CAREONE LIME BASIL ETHYL ALCOHOL LIQUID TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-423_77e52e54-1da8-46fb-87b5-ccaa0f8062d0 41520-423 HUMAN OTC DRUG CAREONE LIME BASIL ETHYL ALCOHOL LIQUID TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-424_ccb9fea3-1e2d-4146-a108-8dbe72d34312 41520-424 HUMAN OTC DRUG CAREONE APPLE BERRY ETHYL ALCOHOL LIQUID TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-430_96c33f61-82a3-47be-8009-e2b4a8315131 41520-430 HUMAN OTC DRUG Care One headache relief added strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 41520-431_14803f99-52c7-4324-b64c-971906144739 41520-431 HUMAN OTC DRUG careone nighttime sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20040413 OTC MONOGRAPH FINAL part338 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41520-432_e2884730-2d68-452a-8433-335b159617bb 41520-432 HUMAN OTC DRUG Care One Suphedrine Nasal Decongestant Non Drowsy Pseudoephedrine HCl TABLET, FILM COATED ORAL 20031201 OTC MONOGRAPH FINAL part341 American Sales Company PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 41520-434_f3907bcd-e4ab-454d-8d0c-ab6b8d5a510a 41520-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130906 OTC MONOGRAPH NOT FINAL part356 Foodhold U.S.A., LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 41520-437_5eca3f54-445e-400a-8a85-095c37d28236 41520-437 HUMAN OTC DRUG care one pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20040413 OTC MONOGRAPH FINAL part338 American Sales Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41520-440_8d5bd0bf-1627-4102-be0f-355230c3104f 41520-440 HUMAN OTC DRUG Aspirin Enteric Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 20100715 OTC MONOGRAPH FINAL part343 Care One (American Sales Company) ASPIRIN 81 mg/1 41520-441_13e80c82-b845-4c2e-945d-a0b7473893e6 41520-441 HUMAN OTC DRUG CARE ONE SLEEP AID Doxylamine succinate TABLET ORAL 20040629 ANDA ANDA040167 American Sales Company DOXYLAMINE SUCCINATE 25 mg/1 41520-442_88d3fdbd-7bbd-4044-b0d8-079a1de2901d 41520-442 HUMAN OTC DRUG careone nicotine polacrilex Nicotine polacrilex GUM, CHEWING ORAL 20120927 ANDA ANDA091354 American Sales Company NICOTINE 4 mg/1 41520-445_cf37cb58-14bc-41a5-9938-448420066a16 41520-445 HUMAN OTC DRUG Nitetime Cold Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130603 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 41520-446_5a08a62c-3472-4ef6-8564-b680594fd6c6 41520-446 HUMAN OTC DRUG DayTime NiteTime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine succinate KIT ORAL 20141030 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) 41520-456_33d186c8-508d-4535-9ec6-153efdb1b5d0 41520-456 HUMAN OTC DRUG Care One Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061212 ANDA ANDA076777 American Sales Company NICOTINE 2 mg/1 41520-458_aaf2c4cf-43dd-4d28-bc11-dc69559de8a8 41520-458 HUMAN OTC DRUG CareOne All Day Allergy Cetirizine Hydrochloride TABLET ORAL 20080123 ANDA ANDA078336 American Sales Company CETIRIZINE HYDROCHLORIDE 10 mg/1 41520-459_308b961e-91aa-40ad-b8ef-7657d26007fb 41520-459 HUMAN OTC DRUG CareOne Nitetime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20130807 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 41520-460_bddf73db-1a6a-491d-99ce-1144590bae9e 41520-460 HUMAN OTC DRUG careone severe sinus congestion and pain Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20140829 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 41520-461_0880a03d-53f6-4e1b-842c-002b2c01ccc3 41520-461 HUMAN OTC DRUG Care One ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20040913 ANDA ANDA076359 American Sales Company IBUPROFEN 100 mg/1 41520-462_373b2274-bbff-429f-b2b7-6b427bc3d03a 41520-462 HUMAN OTC DRUG careone allergy diphenhydramine HCl CAPSULE ORAL 20040727 OTC MONOGRAPH FINAL part341 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 41520-463_2fe993ee-0e79-47cc-9460-5101371d610a 41520-463 HUMAN OTC DRUG careone allergy relief Chlorpheniramine Maleate TABLET ORAL 20040518 OTC MONOGRAPH FINAL part341 American Sales Company CHLORPHENIRAMINE MALEATE 4 mg/1 41520-467_83e673d2-3281-4528-902a-c522086d54d3 41520-467 HUMAN OTC DRUG care one aspirin Aspirin TABLET, CHEWABLE ORAL 20040601 OTC MONOGRAPH NOT FINAL part343 American Sales Company ASPIRIN 81 mg/1 41520-468_1b3c4d55-607f-499c-9ec3-9ce998f5490d 41520-468 HUMAN OTC DRUG care one calcium antacid Calcium carbonate TABLET, CHEWABLE ORAL 20040301 OTC MONOGRAPH FINAL part331 American Sales Company CALCIUM CARBONATE 750 mg/1 41520-469_8c4193a3-a200-4c78-aafc-7a0b702c09c9 41520-469 HUMAN OTC DRUG CARE ONE ANTIBACTERIAL RUM RAISIN ETHYL ALCOHOL LIPSTICK TOPICAL 20120925 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 65 mL/100mL 41520-470_5844de03-3961-49b5-b991-550e4e617390 41520-470 HUMAN OTC DRUG CARE ONE ANTIBACTERIAL TANGERINE SPICE ETHYL ALCOHOL LIQUID TOPICAL 20120925 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-471_61ba017f-3381-4e42-8374-8e297a6b0ba4 41520-471 HUMAN OTC DRUG CARE ONE ANTIBACTERIAL SNOW KISSED PEAR ETHYL ALCOHOL LIQUID TOPICAL 20120926 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-472_d3ea9052-d071-485a-8aca-998e42896582 41520-472 HUMAN OTC DRUG CARE ONE ANTIBACTERIAL PEPPERMINT SWIRL ETHYL ALCOHOL LIQUID TOPICAL 20120927 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-473_1d8c5416-7f2f-4389-b10d-e5e5445b9a1f 41520-473 HUMAN OTC DRUG DAYTIME cold and flu relief ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl CAPSULE, LIQUID FILLED ORAL 20121115 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 41520-474_f30495a7-6931-46ce-b3c6-af50de8352b2 41520-474 HUMAN OTC DRUG CARE ONE SUN KISSED PEAR ETHYL ALCOHOL LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-474_f737bfa1-8d06-43ea-883d-57d43f9dfc64 41520-474 HUMAN OTC DRUG CARE ONE SUN KISSED PEAR ETHYL ALCOHOL LIQUID TOPICAL 20130206 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-475_90504d49-e099-48f5-8079-c0ac2af40ca6 41520-475 HUMAN OTC DRUG CARE ONE CREAMY COCONUT ETHYL ALCOHOL LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-475_93010594-1d5e-4b69-a967-2ac9515ef8a4 41520-475 HUMAN OTC DRUG CARE ONE CREAMY COCONUT ETHYL ALCOHOL LIQUID TOPICAL 20130206 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-476_7fdde583-18d4-4971-8737-cdca25bfa8e3 41520-476 HUMAN OTC DRUG CARE ONE VANILLA APPLE BLOSSOM ETHYL ALCOHOL LIQUID TOPICAL 20130206 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-476_8d3c522d-d70e-48b2-9579-eecb32251d9d 41520-476 HUMAN OTC DRUG CARE ONE VANILLA APPLE BLOSSOM ETHYL ALCOHOL LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-477_886f1706-0f33-4c59-8e66-4faf2d72d79e 41520-477 HUMAN OTC DRUG care one fiber Calcium polycarbophil TABLET, FILM COATED ORAL 20040330 OTC MONOGRAPH NOT FINAL part334 American Sales Company CALCIUM POLYCARBOPHIL 625 mg/1 41520-478_418fd8ea-fc26-472c-bc27-eec96465d712 41520-478 HUMAN OTC DRUG care one calcium antacid calcium carbonate TABLET, CHEWABLE ORAL 20040301 OTC MONOGRAPH FINAL part331 American Sales Company CALCIUM CARBONATE 500 mg/1 41520-479_8b9ae1fb-9a3a-460c-88b0-575803eb5648 41520-479 HUMAN OTC DRUG CARE ONE LEMON VERBENA ETHYL ALCOHOL LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-480_a4610e66-111f-4ec1-a1d2-27e49d17e8b0 41520-480 HUMAN OTC DRUG Nitetime cold and flu relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20120801 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 41520-484_90f58400-e3be-4fd3-b3a2-f1b78330a1f9 41520-484 HUMAN OTC DRUG Care One pain relief extra strength Acetaminophen TABLET ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 500 mg/1 41520-485_85eb5566-5d67-4b4d-99e4-cf564f0c18c7 41520-485 HUMAN OTC DRUG Care One Calcium Antacid calcium carbonate TABLET, CHEWABLE ORAL 20040301 OTC MONOGRAPH FINAL part331 American Sales Company CALCIUM CARBONATE 500 mg/1 41520-489_0e0dad56-f272-498d-8352-0937014faa7e 41520-489 HUMAN OTC DRUG care one calcium antacid Calcium carbonate TABLET, CHEWABLE ORAL 20040301 OTC MONOGRAPH FINAL part331 American Sales Company CALCIUM CARBONATE 750 mg/1 41520-490_00525800-a7c5-421e-bf50-f8482d1082fe 41520-490 HUMAN OTC DRUG care one all day pain relief Naproxen Sodium TABLET ORAL 20040504 ANDA ANDA074661 American Sales Company NAPROXEN SODIUM 220 mg/1 41520-491_330c32e4-d938-44eb-af2d-f1f6e132d91b 41520-491 HUMAN OTC DRUG DayTime Nitetime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120814 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) 41520-496_004ad4e4-b39c-4689-95f5-015d4d955ee9 41520-496 HUMAN OTC DRUG CARE ONE PUMPKIN PIE ETHYL ALCOHOL LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-497_6647ccde-389f-4033-bb5d-2710b6004e3b 41520-497 HUMAN OTC DRUG CARE ONE PEPPERMINT SWIRL ETHYL ALCOHOL LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-498_91d94af9-ab6a-4e3b-9b6e-8462cbf1ae30 41520-498 HUMAN OTC DRUG CareOne Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130421 ANDA ANDA078912 American Sales Company GUAIFENESIN 600 mg/1 41520-499_676285cb-90a5-4431-b8e1-4338ce869093 41520-499 HUMAN OTC DRUG CARE ONE PINE ETHYL ALCOHOL LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-500_53852fee-c7cd-46f2-b78a-875e608593fd 41520-500 HUMAN OTC DRUG CARE ONE VANILLA BEAN ETHYL ALCOHOL LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-501_ee7e69b9-c9f7-4f49-8e7e-a4d172de3fc7 41520-501 HUMAN OTC DRUG CAREONE ANTIBACTERIAL HAND SANITIZER PUMPKIN ROLL ETHYL ALCOHOL LIQUID TOPICAL 20140814 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-502_9ed3bc24-3104-4e3f-b3d2-8e780675711b 41520-502 HUMAN OTC DRUG CAREONE ANTIBACTERIAL HAND SANITIZER FESTIVAL OF LIGHTS ETHYL ALCOHOL LIQUID TOPICAL 20140814 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-503_a1687dcc-957f-4b2c-82f4-4050b3e85780 41520-503 HUMAN OTC DRUG CAREONE ANTIBACTERIAL HAND SANITIZER WINTER SKY ETHYL ALCOHOL LIQUID TOPICAL 20140814 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-504_b2caf221-2b7b-4b05-bbc3-7372fcd0e565 41520-504 HUMAN OTC DRUG CAREONE ANTIBACTERIAL HAND SANITIZER SEASONS GREETINGS ETHYL ALCOHOL LIQUID TOPICAL 20140814 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL 41520-505_ca3e908a-df71-42cf-a4d1-65b9a6420a93 41520-505 HUMAN OTC DRUG CareOne Daily Facial Avobenzone, Octocrylene CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 American Sales Company AVOBENZONE; OCTOCRYLENE 3; 10 mL/100mL; mL/100mL 41520-509_820ec090-0487-4866-bd9f-1839698d82f0 41520-509 HUMAN OTC DRUG Careone Anti Aging Vitamin Complex 7 in 1 Avobenzone, Ensulizole, Octisalate, Octocrylene LOTION TOPICAL 20090508 OTC MONOGRAPH NOT FINAL part352 American Sales Company AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE 2; 1; 4; 1 mL/100mL; mL/100mL; mL/100mL; mL/100mL 41520-513_b9692ba4-8ebc-40db-a9e0-87a4369f5fc1 41520-513 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 American Sales Company LORATADINE 10 mg/1 41520-516_765c5324-ce39-4beb-abc5-7c51d34bd9fd 41520-516 HUMAN OTC DRUG CareOne Adult Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20060620 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 41520-517_acd9cf65-36fc-4587-8a9e-d59597de0925 41520-517 HUMAN OTC DRUG care one ibuprofen ib Ibuprofen TABLET, FILM COATED ORAL 20060524 ANDA ANDA077349 American Sales Company IBUPROFEN 200 mg/1 41520-519_47d501e6-17d1-4f73-b47f-644796c30327 41520-519 HUMAN OTC DRUG Petrolatum White Petrolatum JELLY TOPICAL 19920715 OTC MONOGRAPH FINAL part347 Foodhold USA, LLC PETROLATUM 1 g/g 41520-520_4a528336-6dd8-445a-aaf3-2f87c1199059 41520-520 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100805 NDA NDA021855 Care One (American Sales Company) LOPERAMIDE HYDROCHLORIDE 2 mg/1 41520-521_34c1079f-3550-4707-8e78-18c0b26b5078 41520-521 HUMAN OTC DRUG Care One Ibuprofen Junior Strength Ibuprofen TABLET, CHEWABLE ORAL 20100521 ANDA ANDA076359 American Sales Company IBUPROFEN 100 mg/1 41520-522_334efb13-38cc-4201-86dc-bb75ba5f45a0 41520-522 HUMAN OTC DRUG Baby Healing Petrolatum OINTMENT TOPICAL 20131113 OTC MONOGRAPH FINAL part347 American Sales Company PETROLATUM 41 g/100g 41520-525_2362edeb-ac77-40c2-a066-757729e41e20 41520-525 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 American Sales Company LORATADINE 10 mg/1 41520-527_2362edeb-ac77-40c2-a066-757729e41e20 41520-527 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 American Sales Company LORATADINE 10 mg/1 41520-528_a52f0d20-fe59-48e2-9138-30cbebf322e5 41520-528 HUMAN OTC DRUG care one calcium antacid CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20040301 OTC MONOGRAPH FINAL part331 American Sales Company CALCIUM CARBONATE 750 mg/1 41520-530_e2e1a239-ae03-4bf5-a17d-97075d91d3e1 41520-530 HUMAN OTC DRUG Acne Wash Oil-Free Salicylic Acid LIQUID TOPICAL 20131115 OTC MONOGRAPH FINAL part333D American Sales Company SALICYLIC ACID 2 g/100mL 41520-531_2ccfe1d7-2250-4212-9345-44ceb105ca56 41520-531 HUMAN OTC DRUG Redness reliever tetrahydrozoline HCl LIQUID OPHTHALMIC 20110906 OTC MONOGRAPH FINAL part349 American Sales Company TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 41520-532_a8a645b6-c4f8-4c21-9bbf-661bd417e9de 41520-532 HUMAN OTC DRUG Advanced relief dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl LIQUID OPHTHALMIC 20110907 OTC MONOGRAPH FINAL part349 American Sales Company DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL 41520-540_33c05a6b-9577-4a1f-951f-d8097809ece1 41520-540 HUMAN OTC DRUG Baby Care Healing Petrolatum OINTMENT TOPICAL 20131113 OTC MONOGRAPH FINAL part347 American Sales Company PETROLATUM 41 g/100g 41520-541_a4f8f2f1-8e6e-4d87-9827-6e3ba14febfb 41520-541 HUMAN OTC DRUG CareOne Healing Petrolatum OINTMENT TOPICAL 20131115 OTC MONOGRAPH FINAL part347 American Sales Company PETROLATUM 41 g/100g 41520-544_af7aafaa-e9e5-4370-bdd6-1069edac9a21 41520-544 HUMAN OTC DRUG Care One arthritis pain relief temporary minor Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051122 ANDA ANDA075077 American Sales Company ACETAMINOPHEN 650 mg/1 41520-546_554689d9-7bc2-4c15-8304-c86b76dab2b6 41520-546 HUMAN OTC DRUG care one acid reducer and antacid dual action Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080801 ANDA ANDA077355 American Sales Company CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 41520-550_50f7fd7d-cdcd-4e5d-8cbd-8c307d74f40d 41520-550 HUMAN OTC DRUG Gas relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20101027 OTC MONOGRAPH FINAL part332 Care One (American Sales Company) DIMETHICONE 125 mg/1 41520-552_d343bbc3-5ffb-4bc9-8426-028b2d826908 41520-552 HUMAN OTC DRUG care one flu and severe cold daytime Acetaminophen, Phenylephrine hydrochloride POWDER, FOR SUSPENSION ORAL 20070808 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 650; 10 mg/16000mg; mg/16000mg 41520-571_44a0799b-2615-427e-8cd5-84ccc17d9b0c 41520-571 HUMAN OTC DRUG care one aller ease fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110415 ANDA ANDA076447 American Sales Company FEXOFENADINE HYDROCHLORIDE 180 mg/1 41520-578_0508fd83-4756-4715-aa96-892265275723 41520-578 HUMAN OTC DRUG CareOne Adult Tussin DM sugar free Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20040504 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 41520-582_25d531a1-fda9-4c3c-9db2-b4740675536e 41520-582 HUMAN OTC DRUG Care One Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20130120 OTC MONOGRAPH NOT FINAL part356 American Sales POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 41520-588_08ac52e1-0ece-496b-a0d1-7244f2247396 41520-588 HUMAN OTC DRUG CareOne Antacid Aluminum Hydroxide, Magnesium Hydroxide, Simethicone LIQUID ORAL 20130910 OTC MONOGRAPH FINAL part332 American Sales Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 41520-590_629a3975-fb83-47e9-b76e-33bf2c12c107 41520-590 HUMAN OTC DRUG careone pain relief acetaminophen SUSPENSION ORAL 20111208 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL 41520-595_afef7f53-1d54-4270-bdb8-69d12b4d850a 41520-595 HUMAN OTC DRUG care one calcium antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20040301 OTC MONOGRAPH FINAL part331 American Sales Company CALCIUM CARBONATE 1000 mg/1 41520-600_368e6d1b-8521-4ca6-9151-e69ea7660b04 41520-600 HUMAN OTC DRUG Careone ibuprofen junior strength Ibuprofen TABLET, CHEWABLE ORAL 20100521 ANDA ANDA076359 American Sales Company IBUPROFEN 100 mg/1 41520-604_8fe6a0dd-e320-498a-8899-a1df8fda8bdb 41520-604 HUMAN OTC DRUG care one ibuprofen Ibuprofen TABLET ORAL 20040413 ANDA ANDA072096 American Sales Company IBUPROFEN 200 mg/1 41520-605_1f944136-50ca-4d13-bca2-f9bd96aed2f0 41520-605 HUMAN OTC DRUG Care One Miconazole 3 Miconazole nitrate KIT 20040727 ANDA ANDA075329 American Sales Company 41520-611_9cf5a337-e1cc-4db7-b8bf-974eb5dad658 41520-611 HUMAN OTC DRUG Careone Moisturizing Dandruff Selenium Sulfide SHAMPOO TOPICAL 20110819 OTC MONOGRAPH FINAL part358H American Sales Company SELENIUM SULFIDE 1 mL/100mL 41520-612_c09ad0a5-c545-4d09-8cb9-70ea34847a63 41520-612 HUMAN OTC DRUG CareOne Allergy Relief 24 Hour Loratadine TABLET ORAL 20060602 ANDA ANDA076301 American Sales Company LORATADINE 10 mg/1 41520-614_5e3e215b-f997-4366-9bba-42a47bd5e723 41520-614 HUMAN OTC DRUG MEDICATED DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20110819 OTC MONOGRAPH FINAL part358H AMERICAN SALES COMPANY SELENIUM SULFIDE 1 mL/100mL 41520-619_b3600254-6acf-4c02-a333-50d6401f4419 41520-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20120915 OTC MONOGRAPH FINAL part347 American Sales Co DIMETHICONE 1.3 kg/100mL 41520-620_60ebdc33-d41d-40d5-a5ba-3cb824115c8d 41520-620 HUMAN OTC DRUG CARE ONE MEDICATED SELENIUM SULFIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH FINAL part358H AMERICAN SALES COMPANY SELENIUM SULFIDE 10 mg/mL 41520-621_2ac8a2a1-3a9b-4e8d-8124-5f8dd7cfb96c 41520-621 HUMAN OTC DRUG CARE ONE MOISTURIZING SELENIUM SULFIDE LIQUID TOPICAL 20130715 OTC MONOGRAPH FINAL part358H AMERICAN SALES COMPANY SELENIUM SULFIDE 10 mg/mL 41520-626_17d07bd2-664f-4c67-8c00-0596a2d57ffa 41520-626 HUMAN OTC DRUG CareOne Daily Moisturizer Broad Spectrum SPF15 Sunscreen Avobenzone, Homosalate, Octinoxate, Octocrylene LOTION TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part352 American Sales Company AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3; 3; 5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL 41520-630_6642f605-701c-4943-894e-304888cff191 41520-630 HUMAN OTC DRUG Motion Sickness Relief Original Formula Dimenhydrinate TABLET ORAL 20100715 OTC MONOGRAPH FINAL part336 Care One (American Sales Company) DIMENHYDRINATE 50 mg/1 41520-645_8a2b3e14-f771-4711-a924-32f007158947 41520-645 HUMAN OTC DRUG CareOne loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120521 ANDA ANDA091292 American Sales Company LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 41520-647_1710431d-167a-47cd-88cf-0fd93650f845 41520-647 HUMAN OTC DRUG care one ibuprofen Ibuprofen TABLET, COATED ORAL 20040413 ANDA ANDA072096 American Sales Company IBUPROFEN 200 mg/1 41520-648_d70dc899-ee4f-4322-aa77-c2861639436f 41520-648 HUMAN OTC DRUG Care One Nasal Four Phenylephrine hydrochloride SPRAY NASAL 20040524 OTC MONOGRAPH FINAL part341 American Sales Company PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 41520-656_f32be60e-e90a-4bfc-861f-a2831d66b3dd 41520-656 HUMAN OTC DRUG CareOne Daytime Cold Flu Relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20130813 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 41520-660_7ceda1fd-6a63-40c0-ba74-d2a202aec7bf 41520-660 HUMAN OTC DRUG care one ibuprofen childrens Ibuprofen SUSPENSION ORAL 20040504 ANDA ANDA074937 American Sales Company IBUPROFEN 100 mg/5mL 41520-666_4f622c86-d8af-4c26-948e-a1cbdb592769 41520-666 HUMAN OTC DRUG CareOne Cold and Cough Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20051028 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 41520-678_5f249c8a-3541-483a-98b5-483f89a06f3a 41520-678 HUMAN OTC DRUG CareOne Hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20121208 OTC MONOGRAPH FINAL part346 American Sales Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 41520-685_5b20db92-9ed6-402b-9d1f-eb3bf4493a20 41520-685 HUMAN OTC DRUG Care One ibuprofen childrens Ibuprofen LIQUID ORAL 20080801 ANDA ANDA074937 American Sales Company IBUPROFEN 100 mg/5mL 41520-692_388822eb-6965-4b64-be1d-829346884493 41520-692 HUMAN OTC DRUG Care One Cool Heat Extra Strength Menthol, Methyl salicylate CREAM TOPICAL 20080620 OTC MONOGRAPH NOT FINAL part348 American Sales Company MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g 41520-693_489e98bb-ef9e-4da9-a9d6-d6ef78f11b3f 41520-693 HUMAN OTC DRUG Anti-Aging Vitamin Complex 7-in-1 Broad Spectrum SPF15 Sunscreen Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part352 American Sales Company AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 g/100mL; g/100mL; g/100mL 41520-699_ad36eb7d-358e-4b2c-8e46-faba47edf0be 41520-699 HUMAN OTC DRUG CareOne Arthritis Pain Relief Capsaicin CREAM TOPICAL 20080718 OTC MONOGRAPH NOT FINAL part348 American Sales Company CAPSAICIN .1 g/100g 41520-701_2de43252-3e35-44ec-8f29-7e75f586fe19 41520-701 HUMAN OTC DRUG careone nicotine Nicotine Polacrilex LOZENGE ORAL 20060307 ANDA ANDA077007 American Sales Company NICOTINE 2 mg/1 41520-719_8046242f-b9de-461c-a8b1-04a1b75443ff 41520-719 HUMAN OTC DRUG CAREONE MEDICATED DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20141117 OTC MONOGRAPH FINAL part358H AMERICAN SALES COMPANY SELENIUM SULFIDE 10 mg/mL 41520-721_abf6717d-19f3-41cc-8ebe-f6109b4ba59f 41520-721 HUMAN OTC DRUG American Sales Company CareOne Fluoride PASTE, DENTIFRICE DENTAL 20140601 OTC MONOGRAPH FINAL part355 American Sales Company SODIUM FLUORIDE .243 g/100g 41520-733_511c85ee-5044-4dd7-bd43-df3ab59495dd 41520-733 HUMAN OTC DRUG CareOne Daytime Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20140908 OTC MONOGRAPH FINAL part341 American Sales Company 41520-734_ab2f3873-a8d5-4867-87d8-a14edaef452c 41520-734 HUMAN OTC DRUG CareOne Nicotine Nicotine Polacrilex LOZENGE ORAL 20130628 ANDA ANDA203690 American Sales Company NICOTINE 2 mg/1 41520-742_4cc2aae9-a7a0-4db6-a4f6-cbd06c07b0a2 41520-742 HUMAN OTC DRUG careone naproxen sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20111208 NDA NDA021920 American Sales Company NAPROXEN SODIUM 220 mg/1 41520-751_b53760e8-4f7b-4a73-9758-b1a1c32053f7 41520-751 HUMAN OTC DRUG careone pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120203 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41520-758_8471db91-e87a-4399-a250-276a9f174fbd 41520-758 HUMAN OTC DRUG CareOne Loperamide Hydrochloride Loperamide Hydrochloride SUSPENSION ORAL 20140510 ANDA ANDA091292 American Sales Company LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 41520-759_72cfdb02-2e32-44e5-b86f-35f147493488 41520-759 HUMAN OTC DRUG care one pain relief Acetaminophen SUSPENSION ORAL 20110211 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL 41520-766_1daad7ea-bffa-497e-87c8-4edd682299c0 41520-766 HUMAN OTC DRUG CareOne Mucus Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140730 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 41520-798_fd50f654-4c17-4ed0-9a1a-4a389ef0a48e 41520-798 HUMAN OTC DRUG CareOne Hair Regrowth Treatment Extra Strength Minoxidil SOLUTION TOPICAL 20091215 ANDA ANDA075598 American Sales Company MINOXIDIL 3 g/60mL 41520-799_d68afa37-31bc-4725-9381-dad189b6c1dc 41520-799 HUMAN OTC DRUG CareOne Adult Tussin DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20130903 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 41520-803_ffb6c1e1-44f6-4fc7-9706-f0630a5f02c1 41520-803 HUMAN OTC DRUG CareOne Pain Relief Pain Relief PM Acetaminophen, Diphenhydramine HCl KIT 20131102 OTC MONOGRAPH NOT FINAL part343 American Sales Company 41520-807_b5e2fd0a-a463-42eb-ba5a-2b8e94426f7f 41520-807 HUMAN OTC DRUG CAREONE ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20140323 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 1.5 mg/mL 41520-809_3896ae05-3434-45c0-93d8-42cf234fd7af 41520-809 HUMAN OTC DRUG Alcohol Isopropyl Alcohol SWAB TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part333A American Sales Company, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 41520-817_836e7025-5ca6-4534-bb97-015abf8ebeff 41520-817 HUMAN OTC DRUG care one nasal sinus oxymetazoline hydrochloride SPRAY NASAL 20040524 OTC MONOGRAPH FINAL part341 American Sales Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 41520-827_7ae805e1-e41e-4414-9a1c-1d55298fca5b 41520-827 HUMAN OTC DRUG Quick Relief Creamy Diaper Rash Zinc Oxide CREAM TOPICAL 20131115 OTC MONOGRAPH FINAL part347 American Sales Company ZINC OXIDE 130 mg/g 41520-829_6f3c22a6-8d96-42b3-9275-7fa8dcf85fda 41520-829 HUMAN OTC DRUG care one pain relief pm extra strength Acetaminophen, Diphenhydramine HCl CAPSULE, COATED ORAL 20100903 OTC MONOGRAPH FINAL part338 American Sales Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41520-837_25afd5d8-ac9f-4903-bc6a-ad719abd3e44 41520-837 HUMAN OTC DRUG care one pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20040413 OTC MONOGRAPH FINAL part338 American Sales Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 41520-839_a85d234a-9955-46a4-8120-c1a16afdd6ff 41520-839 HUMAN OTC DRUG CareOne Childrens Mucus Relief dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20140805 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 41520-851_687bd050-fba8-44cf-9a72-19c441d6423f 41520-851 HUMAN OTC DRUG Careone antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20121012 OTC MONOGRAPH FINAL part332 American Sales Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 41520-852_517ccdae-a872-4bb2-ba78-645ffafabc50 41520-852 HUMAN OTC DRUG careone acid reducer Ranitidine TABLET, FILM COATED ORAL 20131130 ANDA ANDA091429 American Sales Company RANITIDINE HYDROCHLORIDE 150 mg/1 41520-854_513d4bd0-485c-45c9-a629-fba8fa8612ba 41520-854 HUMAN OTC DRUG Care One Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20080725 ANDA ANDA078546 American Sales Company NICOTINE 4 mg/1 41520-863_9c1c705f-deab-4b86-8671-0e50174bd027 41520-863 HUMAN OTC DRUG CARE ONE COOL HEAT PAIN RELIEVING MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 AMERICAN SALES COMPANY MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g 41520-865_f76f2e3a-d8b4-4ee3-a1c4-89b79939b3d9 41520-865 HUMAN OTC DRUG Artificial Tears glycerin, hypromellose, polyethylene glycol 400 LIQUID OPHTHALMIC 20100906 OTC MONOGRAPH FINAL part349 American Sales Company GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2; 2; 10 mg/mL; mg/mL; mg/mL 41520-866_7ef839fb-ff01-41df-84c0-aa5263412dc5 41520-866 HUMAN OTC DRUG care one lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070829 OTC MONOGRAPH FINAL part358G American Sales Company PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 41520-869_61a4691e-e9ae-4d8b-91c2-f6cebef0f30a 41520-869 HUMAN OTC DRUG CareOne 7-in-1 Anti-Aging Vitamin Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 American Sales Company AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 mL/100mL; mL/100mL; mL/100mL 41520-871_957e7111-342c-4605-91bf-399a02205eb0 41520-871 HUMAN OTC DRUG Careone Extra Strength Cold and Hot Menthol PATCH TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part348 American Sales Company MENTHOL .05 mg/1 41520-873_d75e659c-b4b5-4353-874b-15d1152331e1 41520-873 HUMAN OTC DRUG care one nicotine Nicotine Polacrilex LOZENGE ORAL 20060307 ANDA ANDA077007 American Sales Company NICOTINE 4 mg/1 41520-878_51970119-d31b-482c-98cc-d651f003f3f1 41520-878 HUMAN OTC DRUG PEANUTS ANTI-CAVITY FLUORIDE TOOTHPASTE SODIUM FLUORIDE PASTE DENTAL 20100913 OTC MONOGRAPH FINAL part355 American Sales Company SODIUM FLUORIDE .24 g/100g 41520-886_55edc748-5c76-4e6f-aded-feb55de7b8f2 41520-886 HUMAN OTC DRUG care one sinus Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20070822 OTC MONOGRAPH FINAL part341 American Sales Company 41520-886_a72ec52b-b32a-4b44-ba34-1a257d3fa3a5 41520-886 HUMAN OTC DRUG careone sinus congestion and pain daytime nighttime Acetaminophen,Phenylephrine HCl, Chlorpheniramine maleate KIT 20110916 OTC MONOGRAPH FINAL part341 American Sales Company 41520-890_22f2fbcf-e696-477b-a15f-c4cdcd275501 41520-890 HUMAN OTC DRUG Cold and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20110629 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 41520-896_6c6722be-b045-4ea5-97b4-a97d1a902429 41520-896 HUMAN OTC DRUG CareOne Lubricant Polyethylene glycol, Propylene glycol SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130709 OTC MONOGRAPH FINAL part349 American Sales Company POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 g/100mL; g/100mL 41520-897_9112a443-4fd1-48c3-9d88-86136ac60726 41520-897 HUMAN OTC DRUG care one ibuprofen Ibuprofen SUSPENSION ORAL 20040428 ANDA ANDA074937 American Sales Company IBUPROFEN 100 mg/5mL 41520-906_0a042307-6e7e-46b0-96d6-08d33a155e54 41520-906 HUMAN OTC DRUG CareOne Childrens Cold and Allergy phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20060907 OTC MONOGRAPH FINAL part341 American Sales Company BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 41520-909_a9b245d4-8bfb-4dbc-a058-f7b40a2dd4d7 41520-909 HUMAN OTC DRUG Complete Beauty Octinoxate, Zinc Oxide LOTION TOPICAL 20100113 OTC MONOGRAPH NOT FINAL part352 American Sales Co OCTINOXATE; ZINC OXIDE 61.2; 30.6 mg/mL; mg/mL 41520-911_d3d1ae52-fd05-4ab9-8aab-db6d86eab410 41520-911 HUMAN OTC DRUG Medicated Pain Relief Menthol PATCH TOPICAL 20110916 OTC MONOGRAPH NOT FINAL part348 American Sales Company MENTHOL 428.5 mg/1 41520-913_76fc34c5-0adc-4565-8d47-ef1ef4b0368b 41520-913 HUMAN OTC DRUG CareOne Triacting Night Time Cold and Cough Childrens Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20090605 OTC MONOGRAPH FINAL part341 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 41520-915_04ef5af8-480f-478e-af84-730cc2635a50 41520-915 HUMAN OTC DRUG care one omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080229 NDA NDA022032 American Sales Company OMEPRAZOLE 20 mg/1 41520-916_c033e255-f004-4f9b-a4de-7a23dc35409c 41520-916 HUMAN OTC DRUG care one miconazole 1 Miconazole nitrate KIT 20101119 ANDA ANDA079114 American Sales Company 41520-917_c09ad598-3e70-488d-9aaa-fa6dcf0247b7 41520-917 HUMAN OTC DRUG Care One Pain Relief extra strength Acetaminophen CAPSULE, COATED ORAL 20110204 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 500 mg/1 41520-922_6b78bbd4-b9ee-4de5-845e-a3fe08f87016 41520-922 HUMAN OTC DRUG CareOne Mucus Relief Severe Congestion and Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130823 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 41520-923_feec6b2b-3459-4dfc-b569-6f45f84642e9 41520-923 HUMAN OTC DRUG care one eye itch relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20100830 ANDA ANDA077958 American Sales Company KETOTIFEN FUMARATE .25 mg/mL 41520-927_cd539300-2278-45c6-bcd3-8282cd850ca7 41520-927 HUMAN OTC DRUG Maximum Strength Original Diaper Rash Zinc Oxide CREAM TOPICAL 20131115 OTC MONOGRAPH FINAL part347 American Sales Company ZINC OXIDE 400 mg/g 41520-941_454662f8-b269-4d9d-810c-160c4a8d2486 41520-941 HUMAN OTC DRUG CAREONE LEMON ETHYL ALCOHOL LIQUID TOPICAL 20140126 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 700 mg/mL 41520-946_442019f1-4c62-453d-89c3-c7600411d6b9 41520-946 HUMAN OTC DRUG careone pain relief infants Acetaminophen SUSPENSION ORAL 20110902 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL 41520-949_5e862cdc-4acb-4dbb-a33b-d6ea8c6ec8aa 41520-949 HUMAN OTC DRUG careone milk of magnesia Magnesium hydroxide LIQUID ORAL 20120826 OTC MONOGRAPH NOT FINAL part334 American Sales Company MAGNESIUM HYDROXIDE 1200 mg/15mL 41520-950_921710e8-7761-4c68-bbe2-d547c898f714 41520-950 HUMAN OTC DRUG CareOne Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20130922 ANDA ANDA091429 American Sales Company RANITIDINE HYDROCHLORIDE 150 mg/1 41520-951_29986403-e069-4685-9f94-4176c12ad8e5 41520-951 HUMAN OTC DRUG CareOne Day Time Severe Cold Night Time Cold and Flu Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl, diphenhydramine HCl KIT 20140826 OTC MONOGRAPH FINAL part341 American Sales Company 41520-952_fc8bf999-6500-4222-9e09-42de1d006148 41520-952 HUMAN OTC DRUG Hand wash Benzalkonium chloride SOAP TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333A American Sales BENZALKONIUM CHLORIDE 1.3 mg/mL 41520-957_dfab6b32-8bb2-44ba-9181-3b6d6a809a2c 41520-957 HUMAN OTC DRUG CareOne Mini Nicotine Polacrilex Nicotine Polacrilex LOZENGE ORAL 20130622 ANDA ANDA203690 American Sales Company NICOTINE 4 mg/1 41520-958_42f67a3c-8cd7-44a6-8e54-08fb8449e8d7 41520-958 HUMAN OTC DRUG CareOne Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130823 ANDA ANDA091135 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 41520-959_a85fac16-5351-45de-aa05-848603f9fa66 41520-959 HUMAN OTC DRUG careone childrens pain and fever Acetaminophen SUSPENSION ORAL 20120909 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL 41520-960_52bcbc35-0b39-4f63-9583-038caced2976 41520-960 HUMAN OTC DRUG care one anti diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20040123 ANDA ANDA075232 American Sales Company LOPERAMIDE HYDROCHLORIDE 2 mg/1 41520-964_10b1b0fb-dcbf-4586-8f14-88df5b11e5a0 41520-964 HUMAN OTC DRUG care one flu and severe cold and cough nighttime Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20101107 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 41520-966_aef4fb40-0c1f-442d-9291-d06b024ce4c8 41520-966 HUMAN OTC DRUG care one arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091215 ANDA ANDA075077 American Sales Company ACETAMINOPHEN 650 mg/1 41520-969_a500406f-8658-469c-90b2-ccab159db5bc 41520-969 HUMAN OTC DRUG Care One Pain Relief and Pain Relief PM Acetaminophen, Diphenhydramine HCl KIT 20060930 OTC MONOGRAPH FINAL part338 American Sales Company 41520-973_c53bacee-c55e-4cb1-9ac0-7f4c81b88cdf 41520-973 HUMAN OTC DRUG care one hydrocortisone maximum strength hydrocortisone CREAM TOPICAL 20101112 OTC MONOGRAPH NOT FINAL part348 American Sales Company HYDROCORTISONE 1 g/100g 41520-974_bb96a5aa-fdf9-4667-8261-5bc88216df29 41520-974 HUMAN OTC DRUG CareOne All Day Allergy Childrens Cetirizine Hydrochloride LIQUID ORAL 20080418 ANDA ANDA090254 American Sales Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 41520-975_448356cb-7794-450b-8810-272489e6981e 41520-975 HUMAN OTC DRUG Care One Medicated Lip Balm Petrolatum STICK TOPICAL 20130311 OTC MONOGRAPH FINAL part347 American Sales Company PETROLATUM 41 mg/g 41520-976_0c9d4c39-a4ba-41d6-80f5-93bf38961de4 41520-976 HUMAN OTC DRUG Care One Medicated Lip Balm in a Pot Petrolatum OINTMENT TOPICAL 20130312 OTC MONOGRAPH FINAL part347 American Sales Company PETROLATUM 43.75 mg/g 41520-977_de0225a7-cf38-488e-8085-81d27f354b71 41520-977 HUMAN OTC DRUG Care One Moisture SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH FINAL part352 American Sales Company OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 40.7 mg/g; mg/g; mg/g 41520-978_c8d6a93f-942b-4441-909c-0325bcbec4f5 41520-978 HUMAN OTC DRUG Care One Cherry SPF 4 Lip Balm Padimate O, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH FINAL part352 American Sales Company PADIMATE O; PETROLATUM 1.5; 44 mg/g; mg/g 41520-979_dd6e8327-896a-4479-ae40-41201d78f1f2 41520-979 HUMAN OTC DRUG Care One Original SPF 4 Lip Balm Padimate O, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH FINAL part352 American Sales Company PADIMATE O; PETROLATUM 1.5; 44 mg/g; mg/g 41520-980_c005330b-5cb0-48d6-9d24-634d5ecd7722 41520-980 HUMAN OTC DRUG Care One Pain Relief Acetaminophen SUSPENSION/ DROPS ORAL 20110311 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 80 mg/.8mL 41520-981_682f31ff-0569-4683-8b8e-91b9476ee2fb 41520-981 HUMAN OTC DRUG care one cold head congestion Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20071003 OTC MONOGRAPH FINAL part341 American Sales Company 41520-987_cce5ba29-d529-4fe1-8ab9-fc5bcd5d4d14 41520-987 HUMAN OTC DRUG CareOne Childrens Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20060907 OTC MONOGRAPH FINAL part341 American Sales Company BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 41520-995_df51c4c8-14f5-43b4-b156-cc5a1f9dcf97 41520-995 HUMAN OTC DRUG CareOne NiteTime Cough Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20040518 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 41525-5001_a70078b9-c78a-4fd5-8b1e-0e8ac22eb2eb 41525-5001 HUMAN OTC DRUG The Gargle SODIUM FLUORIDE MOUTHWASH DENTAL 20140911 OTC MONOGRAPH FINAL part355 PBS Co., Ltd. SODIUM FLUORIDE .02 mg/100mL 41525-6001_d4edc948-7977-4452-9808-7dad09319d54 41525-6001 HUMAN OTC DRUG Dental Pro SODIUM FLUORIDE MOUTHWASH DENTAL 20140911 OTC MONOGRAPH FINAL part355 PBS Co., Ltd. SODIUM FLUORIDE .02 mg/100mL 41595-1058_6ec59bf1-1ccd-4428-a013-f42954521a9e 41595-1058 HUMAN OTC DRUG Ammens Medicated Powder Original Zinc Oxide POWDER TOPICAL 20030201 OTC MONOGRAPH FINAL part347 Idelle Labs, Ltd ZINC OXIDE 9.1 g/100g 41595-1059_04eebc94-3032-4757-be4d-875353c1d10a 41595-1059 HUMAN OTC DRUG Ammens Medicated Powder Shower Fresh Formula Zinc Oxide POWDER TOPICAL 20030201 OTC MONOGRAPH FINAL part347 Idelle Labs, Ltd ZINC OXIDE 9.1 g/100g 41595-3020_af88c848-2eb4-48f0-8bac-b13b2c5b5bd4 41595-3020 HUMAN OTC DRUG Sea Breeze Actives Clear-Pore Astringent Salicylic acid LIQUID TOPICAL 20030201 OTC MONOGRAPH FINAL part333D Idelle Labs, Ltd SALICYLIC ACID 1 g/100mL 41595-3022_176acd34-53af-4b93-83b0-82ddaf599df5 41595-3022 HUMAN OTC DRUG Sea Breeze Actives Deep-Clean Astringent Salicylic acid LIQUID TOPICAL 20030201 OTC MONOGRAPH FINAL part333D Idelle Labs, Ltd SALICYLIC ACID 1 g/100mL 41595-5401_28823ec0-b72a-4758-9759-20471bcd7b60 41595-5401 HUMAN OTC DRUG Sure Conditioning Solid Pure Essence Aluminum Zirconium Tricholorohydrex GLY STICK TOPICAL 20120823 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 41595-5421_dfdd00ca-c716-4ec8-849e-624d757812f5 41595-5421 HUMAN OTC DRUG Sure Fresh Essence Aluminum Zirconium Tricholorohydrex GLY STICK TOPICAL 20120823 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 41595-5441_16555fb4-6d70-4f03-acce-9369faa64c5f 41595-5441 HUMAN OTC DRUG Sure Conditioning Solid Vitamin Infusion Aluminum Zirconium Tricholorohydrex GLY STICK TOPICAL 20120823 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 41595-5509_ccf444a1-2951-4310-a275-f052d8cd7d80 41595-5509 HUMAN OTC DRUG Sure Invisible Solid Unscented Aluminum Zirconium Tricholorohydrex GLY STICK TOPICAL 20091222 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 41595-5510_2d97294e-3690-4cef-beca-9216eecffc2b 41595-5510 HUMAN OTC DRUG Sure Invisible Solid Regular Aluminum Zirconium Tricholorohydrex GLY STICK TOPICAL 20091222 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 41595-5511_5f680016-f3f0-42b3-913b-e2b9f7b2fe46 41595-5511 HUMAN OTC DRUG Sure Invisible Solid Fresh Scent Aluminum Zirconium Tricholorohydrex GLY STICK TOPICAL 20110415 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 41595-5512_b260e97d-034f-4b16-9657-38c488fa6b45 41595-5512 HUMAN OTC DRUG Sure Invisible Solid Powder Scent Aluminum Zirconium Tricholorohydrex GLY STICK TOPICAL 20091222 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 41595-5513_7f9116f2-e172-421e-892f-0a22607129ae 41595-5513 HUMAN OTC DRUG Sure Original Solid Unscented Aluminum Zirconium Tricholorohydrex GLY STICK TOPICAL 20091222 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 16 g/100g 41595-5514_52d43f17-f3a7-4424-a23f-030cb27215c5 41595-5514 HUMAN OTC DRUG Sure Original Solid Regular Aluminum Zirconium Tricholorohydrex GLY STICK TOPICAL 20091222 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 16 g/100g 41595-5515_7632f7e5-8dce-4361-af43-490167ecae6f 41595-5515 HUMAN OTC DRUG Sure Original Solid Fresh Scent Aluminum Zirconium Tricholorohydrex GLY STICK TOPICAL 20091222 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 16 g/100g 41595-5516_5a3b215c-51e0-4a7b-a241-0d7e5a6c559d 41595-5516 HUMAN OTC DRUG Sure Original Solid Powder Aluminum Zirconium Tricholorohydrex GLY STICK TOPICAL 20091222 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 16 g/100g 41595-5517_6de2f180-161c-455c-8169-0302462e2fd1 41595-5517 HUMAN OTC DRUG Sure Antiperspirant Deodorant Unscented Aluminum Chlorohydrate AEROSOL TOPICAL 20080201 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM CHLOROHYDRATE 12 g/100g 41595-5518_030f4992-b9ce-452c-854c-761ebe533d78 41595-5518 HUMAN OTC DRUG Sure Antiperspirant Deodorant Regular Aluminum Chlorohydrate AEROSOL TOPICAL 20080201 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM CHLOROHYDRATE 12 g/100g 41595-5519_e940a2c1-08fb-49ef-805f-06f992e33f65 41595-5519 HUMAN OTC DRUG Sure Antiperspirant Deodorant Fresh Aluminum Chlorohydrate AEROSOL TOPICAL 20080201 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM CHLOROHYDRATE 12 g/100g 41595-5520_4c2a9684-196a-47d9-9be0-a34131c15af5 41595-5520 HUMAN OTC DRUG Sure for Men Invisible Solid Crisp Breeze STICK TOPICAL 20091010 OTC MONOGRAPH FINAL part350 Innovative Brands, LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g 41595-5521_bd5f725e-378d-406c-8cbe-b620ec9357e5 41595-5521 HUMAN OTC DRUG Sure for Men Invisible Solid Mountain Frost STICK TOPICAL 20091010 OTC MONOGRAPH FINAL part350 Innovative Brands, LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g 41595-5522_175a167c-82e8-4980-9ef8-e8409ba70548 41595-5522 HUMAN OTC DRUG Sure for Men Invisible Solid Antiperspirant Outdoor Sport Aluminum Zirconium Tricholorohydrex GLY STICK TOPICAL 20111015 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g 41595-5523_c50f9911-25be-4247-ba7c-9e85912fa3b4 41595-5523 HUMAN OTC DRUG Pert Plus for Men Daily Dandruff Pyrithione Zinc SHAMPOO, SUSPENSION TOPICAL 20100401 OTC MONOGRAPH FINAL part358H Idelle Labs, Ltd PYRITHIONE ZINC 1 mL/100mL 41595-5526_b6bf7b2b-aa1b-4a34-8dcb-a28bcefd7311 41595-5526 HUMAN OTC DRUG Pert Plus Dandruff Plus Pyrithione Zinc SHAMPOO, SUSPENSION TOPICAL 20091201 OTC MONOGRAPH FINAL part358H Idelle Labs, Ltd PYRITHIONE ZINC .45 mL/100mL 41595-5527_b860c8fd-50ab-478a-9820-523f1b288c3b 41595-5527 HUMAN OTC DRUG Sure for Women Invisible Solid Citrus Escape STICK TOPICAL 20091210 OTC MONOGRAPH FINAL part350 Innovative Brands, LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 41595-5528_62807030-e650-4c47-ae77-95a6c4b0b54b 41595-5528 HUMAN OTC DRUG Sure for Women Invisible Solid Sparkling Bloom STICK TOPICAL 20091210 OTC MONOGRAPH FINAL part350 Innovative Brands, LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 41595-5529_2fc22278-4e90-445e-a5d2-a5a45b6f1610 41595-5529 HUMAN OTC DRUG Sure for Women Invisible Solid Fresh Essence STICK TOPICAL 20091210 OTC MONOGRAPH FINAL part350 Innovative Brands, LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 41595-5537_4ebeeeeb-1a70-46b2-8d03-df04b13a9be2 41595-5537 HUMAN OTC DRUG Sure for Women Invisible Solid Unscented STICK TOPICAL 20091210 OTC MONOGRAPH FINAL part350 Innovative Brands, LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g 41595-6502_02b5ae60-97b4-4c00-8fc9-ea5181a6f15d 41595-6502 HUMAN OTC DRUG Pert Plus 2 in 1 Shampoo and Conditioner Anti-Dandruff Pyrithione Zinc SHAMPOO, SUSPENSION TOPICAL 20120601 OTC MONOGRAPH FINAL part358H Idelle Labs, Ltd PYRITHIONE ZINC 1 mL/100mL 41595-6503_d5990c17-51b6-4490-835c-cde48e32ebdb 41595-6503 HUMAN OTC DRUG Pert Plus 2 in 1 Shampoo and Conditioner Dry Scalp Care Pyrithione Zinc SHAMPOO, SUSPENSION TOPICAL 20120601 OTC MONOGRAPH FINAL part358H Idelle Labs, Ltd PYRITHIONE ZINC 1 mL/100mL 41595-7005_0c08ec62-0334-4c16-91a3-2b3f49fc9a14 41595-7005 HUMAN OTC DRUG Brut Anti-perspirant and Deodorant Original Fragrance Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20101204 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 41595-7007_5ce1ed8c-d828-4917-9c0d-49aeb930d6f4 41595-7007 HUMAN OTC DRUG BRUT Active Sport Aluminum Zirconium Tetrachlorohydrex Gly GEL TOPICAL 20130101 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 16.15 g/85g 41595-7008_589b125a-6546-410a-ad84-698ced187ee6 41595-7008 HUMAN OTC DRUG Brut Black Ice Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20131126 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 41595-7009_8a2e5270-6eb9-48c3-9ebf-843ff7f33f9c 41595-7009 HUMAN OTC DRUG Brut Blue Wave Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20131126 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 41595-7010_67701fb0-90e3-496d-b9e0-ccf43e3b0a86 41595-7010 HUMAN OTC DRUG Brut Overdrive Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20141028 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 41595-7011_7d2f1499-6037-4498-95c8-565a56e6fd70 41595-7011 HUMAN OTC DRUG Brut Stamina Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20141028 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 41595-7101_fded4583-1798-4ffd-a892-685b6be90eee 41595-7101 HUMAN OTC DRUG Brut Anti-perspirant and Deodorant Original Fragrance Aluminum Chlorohydrate AEROSOL TOPICAL 20030401 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM CHLOROHYDRATE 8.8 g/100g 41616-219_ace0b68a-a576-408a-89de-345fa17910cb 41616-219 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION OPHTHALMIC 20091106 ANDA ANDA090017 Sun Pharma Global Inc. KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 41616-220_ace0b68a-a576-408a-89de-345fa17910cb 41616-220 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION OPHTHALMIC 20091106 ANDA ANDA090017 Sun Pharma Global Inc. KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 41616-221_ace0b68a-a576-408a-89de-345fa17910cb 41616-221 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION OPHTHALMIC 20091106 ANDA ANDA090017 Sun Pharma Global Inc. KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 41616-485_91501890-f01d-496f-ae25-82ff297dbd53 41616-485 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET ORAL 20090707 ANDA ANDA079110 SUN PHARMA GLOBAL INC. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 41616-635_7a6e6128-b7fa-4d21-a1c0-fe3ddcaec10e 41616-635 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080910 ANDA ANDA090022 Sun Pharma Global Inc. ALENDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 41616-636_7a6e6128-b7fa-4d21-a1c0-fe3ddcaec10e 41616-636 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080910 ANDA ANDA090022 Sun Pharma Global Inc. ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 41616-637_7a6e6128-b7fa-4d21-a1c0-fe3ddcaec10e 41616-637 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080910 ANDA ANDA090022 Sun Pharma Global Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 41616-638_7a6e6128-b7fa-4d21-a1c0-fe3ddcaec10e 41616-638 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080910 ANDA ANDA090022 Sun Pharma Global Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 41616-758_989705dd-929b-4b62-9ef4-e768f0e366cb 41616-758 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100818 ANDA ANDA091272 Sun Pharma Global Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 41616-759_989705dd-929b-4b62-9ef4-e768f0e366cb 41616-759 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100818 ANDA ANDA091272 Sun Pharma Global Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 41616-760_989705dd-929b-4b62-9ef4-e768f0e366cb 41616-760 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100818 ANDA ANDA091272 Sun Pharma Global Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 41616-882_e05b4fe4-dd88-4aa2-a6c7-7b2b5618b69f 41616-882 HUMAN PRESCRIPTION DRUG NICARdipine Hydrochloride NICARdipine Hydrochloride INJECTION INTRAVENOUS 20091117 NDA NDA078405 Sun Pharma Global Inc. NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 41616-931_294819e9-aa55-49a3-b1d9-050a4285d3ed 41616-931 HUMAN PRESCRIPTION DRUG Vecuronium Bromide for Injection Vecuronium Bromide for Injection INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090721 ANDA ANDA079001 SUN PHARMA GLOBAL INC. VECURONIUM BROMIDE 1 mg/mL 41616-932_294819e9-aa55-49a3-b1d9-050a4285d3ed 41616-932 HUMAN PRESCRIPTION DRUG Vecuronium Bromide for Injection Vecuronium Bromide for Injection INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090721 ANDA ANDA079001 SUN PHARMA GLOBAL INC. VECURONIUM BROMIDE 1 mg/mL 41616-936_e08e560f-742e-458e-adf9-037a088a5cfd 41616-936 HUMAN PRESCRIPTION DRUG LEUPROLIDE ACETATE LEUPROLIDE ACETATE KIT SUBCUTANEOUS 20090303 ANDA ANDA078885 Sun Pharma Global Inc. 41900-100_69db7bce-3f58-441b-8eb2-141cac252fa2 41900-100 HUMAN OTC DRUG Quik Gel Advanced Hand Sanitizing Gel GEL TOPICAL 20090905 OTC MONOGRAPH NOT FINAL part333 Cinogen Cosmetics Zhaoqing, LTD. ALCOHOL; TRICLOSAN .62; .03 mL/mL; mL/mL 41900-110_d63a1401-f218-45bc-9b8f-9343ac2d2ffe 41900-110 HUMAN OTC DRUG Take Care Clinic Instant Hand Sanitizer Spray ALCOHOL SPRAY TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Cinogen Cosmetics Zhaoqing, Ltd. ALCOHOL 62 mL/100mL 41900-200_c1f1baa9-f90b-4b8c-bea6-ebe8707dbcce 41900-200 HUMAN OTC DRUG Quik Gel Advanced Hand Sanitizing Gel GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Cinogen Cosmetics Zhaoqing, LTD. ALCOHOL; TRICLOSAN .62; .03 g/g; g/g 41900-300_62ecf9eb-1786-4dc9-9f58-2ec677f5aa6b 41900-300 HUMAN OTC DRUG Quik Spray Advanced Hand Sanitizing Spray SPRAY TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Cinogen Cosmetics Zhaoqing, LTD. ALCOHOL .62 mL/mL 41900-400_c558964f-0a02-4190-903b-836f54cc89e1 41900-400 HUMAN OTC DRUG Quik Wipes Advanced Hand Sanitizing Wipes SWAB TOPICAL 20090905 OTC MONOGRAPH NOT FINAL part333 Cinogen Cosmetics Zhaoqing, LTD. ALCOHOL; TRICLOSAN .62; .003 1/1; 1/1 41900-500_78ec0a6b-2382-42ff-8cb5-40d45576e022 41900-500 HUMAN OTC DRUG Quik Spray Advanced Hand Sanitizing Spray SPRAY TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Cinogen Cosmetics Zhaoqing, LTD. ALCOHOL; TRICLOSAN .62; .03 mL/mL; mL/mL 42002-101_6a2d5587-d5f9-4f46-b313-6a8216cb4985 42002-101 HUMAN OTC DRUG Mens Rogaine Extra Strength Minoxidil SOLUTION TOPICAL 20100716 NDA NDA020834 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. MINOXIDIL 50 mg/mL 42002-105_5f917f7e-3443-4b98-9cf9-2f5c9810c2b5 42002-105 HUMAN OTC DRUG Womens Rogaine - Unscented Minoxidil SOLUTION TOPICAL 20100801 NDA NDA019501 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. MINOXIDIL 20 mg/mL 42002-106_dffcab2d-481d-427b-a5e6-5357d8a5b1b9 42002-106 HUMAN OTC DRUG Mens rogaine Unscented Formula Minoxidil AEROSOL, FOAM TOPICAL 20101001 NDA NDA021812 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. MINOXIDIL 50 mg/g 42002-107_24236b76-fe78-40e8-bd60-81a09bee632c 42002-107 HUMAN OTC DRUG Womens Rogaine Unscented Minoxidil AEROSOL, FOAM TOPICAL 20140922 NDA NDA021812 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. MINOXIDIL 50 mg/g 42002-200_2a3c54c8-8e93-4d84-be49-60919be7c983 42002-200 HUMAN OTC DRUG Visine A Multi-Action Eye Allergy Relief Naphazoline Hydrochloride and Pheniramine Maleate LIQUID OPHTHALMIC 20101215 NDA NDA020485 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .25; 3 mg/mL; mg/mL 42002-201_371c40f0-d217-4a23-9e53-358e08b78ee7 42002-201 HUMAN OTC DRUG Visine A.C. Tetrahydrozoline Hydrochloride and Zinc Sulfate LIQUID OPHTHALMIC 20110916 OTC MONOGRAPH FINAL part349 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL 42002-202_9329b993-93c5-4bbe-9f5f-b2dd956a0e59 42002-202 HUMAN OTC DRUG Visine Advanced Relief Dextran 70, Polyethylene Glycol 400, Povidone, and Tetrahydrozoline Hydrochloride LIQUID OPHTHALMIC 20110515 OTC MONOGRAPH FINAL part349 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 11.28; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL 42002-203_0e0bd1f6-18e8-464f-92e5-1a2fb49d7458 42002-203 HUMAN OTC DRUG Visine Original Redness Relief Tetrahydrozoline Hydrochloride LIQUID OPHTHALMIC 20110825 OTC MONOGRAPH FINAL part349 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 42002-204_dd0e1315-26d5-4459-9483-6d8e81c72399 42002-204 HUMAN OTC DRUG Visine L.R. Oxymetazoline Hydrochloride LIQUID OPHTHALMIC 20100405 NDA NDA019407 Johnson & Johnson Healthcare Products Inc., Division of McNEIL-PPC, Inc. OXYMETAZOLINE HYDROCHLORIDE .25 mg/mL 42002-206_64b2a509-cd15-47f6-ab0f-2d77d22e32c6 42002-206 HUMAN OTC DRUG Visine Tears Dry Eye Relief Glycerin, Hypromelloses, and Polyethylene Glycol 400 LIQUID OPHTHALMIC 20110909 OTC MONOGRAPH NOT FINAL part349 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2.5; 2; 11.28 mg/mL; mg/mL; mg/mL 42002-207_b151ed19-95db-4a57-a781-0e9fdb75978e 42002-207 HUMAN OTC DRUG Visine Tears Long Lasting Dry Eye Relief Glycerin, Hypromelloses, and Polyethylene Glycol 400 LIQUID OPHTHALMIC 20110909 OTC MONOGRAPH NOT FINAL part349 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2.5; 3.6; 11.28 mg/mL; mg/mL; mg/mL 42002-209_c4b688a9-7413-4025-8d66-39e3ee506510 42002-209 HUMAN OTC DRUG Visine Totality Multi Symptom Relief Glycerin, Hypromelloses, Polyethylene Glycol 400, Tetrahydrozoline Hydrochloride, and Zinc Sulfate LIQUID OPHTHALMIC 20110823 OTC MONOGRAPH FINAL part349 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE 2.5; 3.6; 11.28; .5; 2.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 42002-211_303d6fc6-0a8d-4371-8b3b-0a7e60a380cc 42002-211 HUMAN OTC DRUG Visine Maximum Strength Redness Relief Formula Glycerin, Hypromelloses, Polyethylene Glycol 400, and Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20110629 OTC MONOGRAPH FINAL part349 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE 2.5; 3.6; 11; .5 mg/mL; mg/mL; mg/mL; mg/mL 42002-212_5c2c2025-d5c0-4b3f-9cd5-dcadf7ddc35c 42002-212 HUMAN OTC DRUG Visine Tired Eye Relief Lubricant Glycerin, Hypromelloses, and Polyethylene Glycol 400 SOLUTION/ DROPS OPHTHALMIC 20120518 OTC MONOGRAPH FINAL part349 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2.5; 3.6; 11.28 mg/mL; mg/mL; mg/mL 42002-213_bc2142ac-f3bd-4ab7-ba15-0c7c44ffb9b6 42002-213 HUMAN OTC DRUG Visine Summer Spectrum Relief Tetrahydrozoline Hydrochloride, Polyethylene Glycol 400, Povidone, and Dextran 70 LIQUID OPHTHALMIC 20110101 OTC MONOGRAPH FINAL part349 Johnson & Johnson Healthcare Products Inc., Division of McNEIL-PPC, Inc. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 11.28; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL 42002-214_9329b993-93c5-4bbe-9f5f-b2dd956a0e59 42002-214 HUMAN OTC DRUG Visine Advanced Relief Dextran 70, Polyethylene Glycol 400, Povidone, Tetrahydrozoline Hydrochloride KIT 20110603 OTC MONOGRAPH FINAL part349 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. 42002-215_9329b993-93c5-4bbe-9f5f-b2dd956a0e59 42002-215 HUMAN OTC DRUG Visine Advanced Relief Dextran 70, Polyethylene Glycol 400, Povidone, Tetrahydrozoline Hydrochloride KIT 20110603 OTC MONOGRAPH FINAL part349 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. 42002-401_ae44b9e0-33dd-423d-9372-59878c690c83 42002-401 HUMAN OTC DRUG Listerine Antiseptic Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20120221 OTC MONOGRAPH NOT FINAL part356 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42002-402_998fe9d3-39cc-4911-9a97-0bacc93644ee 42002-402 HUMAN OTC DRUG Listerine Cool Mint Antiseptic Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20120221 OTC MONOGRAPH NOT FINAL part356 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42002-403_f0c6b346-44e1-4823-bc15-9e09a071467a 42002-403 HUMAN OTC DRUG Listerine FreshBurst Antiseptic Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20120221 OTC MONOGRAPH NOT FINAL part356 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42002-404_b225cc1a-bdb6-445f-a28d-bc1d8c67f8a8 42002-404 HUMAN OTC DRUG Soft Mint Listerine Antiseptic Eucalyptol, Menthol, Methyl Salicylate and Thymol MOUTHWASH DENTAL 20100205 OTC MONOGRAPH NOT FINAL part356 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42002-407_5071f192-6630-43fe-82f2-e63d5523ac01 42002-407 HUMAN OTC DRUG Listerine Advanced with Tartar Protection Antiseptic Citrus Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20131011 OTC MONOGRAPH NOT FINAL part356 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42002-411_86501f12-635d-4b8f-94fd-f19574e72c17 42002-411 HUMAN OTC DRUG Listerine Essential Care Sodium Monofluorophosphate GEL, DENTIFRICE ORAL 20120312 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 42002-412_f875d156-d748-4af9-bcad-6c83595b152e 42002-412 HUMAN OTC DRUG Listerine Essential Care Tartar Control Sodium Monofluorophosphate GEL, DENTIFRICE ORAL 20120312 20150401 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM MONOFLUOROPHOSPHATE 1.3 mg/g 42002-413_09d449e5-0d3a-4194-9109-9bd15f47c0f9 42002-413 HUMAN OTC DRUG Listerine Essential Care Sodium Monofluorophosphate PASTE, DENTIFRICE ORAL 20120312 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM MONOFLUOROPHOSPHATE 1.3 mg/g 42002-416_07164be2-c167-4bca-99d2-3b9917275ab8 42002-416 HUMAN OTC DRUG Listerine Smart Rinse Mint Shield Sodium Fluoride MOUTHWASH ORAL 20120725 OTC MONOGRAPH NOT FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .221 g/mL 42002-417_1b6c4859-b040-4c71-a555-29b0b026270e 42002-417 HUMAN OTC DRUG Listerine Smart Rinse Berry Shield Sodium Fluoride MOUTHWASH ORAL 20120725 OTC MONOGRAPH NOT FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .221 g/mL 42002-418_bd667be4-7101-4a62-ab5b-f7a3ad9b6d04 42002-418 HUMAN OTC DRUG Listerine Smart Rinse Barbie Sodium Fluoride MOUTHWASH ORAL 20110201 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .221 g/mL 42002-419_a05dddb1-6330-43c1-b9f6-de18bff0b664 42002-419 HUMAN OTC DRUG Listerine Smart Rinse Phineas and Ferb Bubble Blast Sodium Fluoride MOUTHWASH ORAL 20110201 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .221 g/mL 42002-420_78490ae7-f023-495a-8212-1d8e09b966d8 42002-420 HUMAN OTC DRUG Listerine Whitening Restoring Sodium Fluoride RINSE ORAL 20120501 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .2 mg/mL 42002-421_3674a18a-54a9-4ab3-8e39-fa0da779f52b 42002-421 HUMAN OTC DRUG LISTERINE TOTAL CARE Anticavity - Fresh Mint Sodium fluoride MOUTHWASH DENTAL 20091130 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .1 mg/mL 42002-423_77e3e1b0-e8b4-413b-9ce2-4f0d5f8aa74a 42002-423 HUMAN OTC DRUG Listerine Total Care Anticavity Cinnamint Sodium Fluoride MOUTHWASH ORAL 20120509 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .02 mg/mL 42002-427_1bb920f8-2de5-4b77-be1f-a8e4267be368 42002-427 HUMAN OTC DRUG Listerine Total Care Plus Whitening Sodium Fluoride MOUTHWASH DENTAL 20100701 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .1 mg/mL 42002-428_b23cc753-2473-4714-a2d0-04af1e228ecc 42002-428 HUMAN OTC DRUG Listerine Whitening Fluoride Anticavity Original Sodium Monofluorophosphate GEL, DENTIFRICE ORAL 20121112 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 42002-440_ad98c9bb-0e6c-4228-b301-c064afed8f41 42002-440 HUMAN OTC DRUG Rembrandt Intense Stain Brilliant Mint Sodium Fluoride PASTE, DENTIFRICE ORAL 20120316 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE 2.4 mg/g 42002-441_c2560f8d-6666-4f95-aadd-500d62da348c 42002-441 HUMAN OTC DRUG Rembrandt Canker Sore Mint Sodium Fluoride PASTE, DENTIFRICE ORAL 20120316 20160801 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE 2.43 mg/g 42002-442_2cedf5b4-1759-4069-a6b9-38c98a4f9eee 42002-442 HUMAN OTC DRUG Rembrandt Deeply White Plus Peroxide Whitening Fresh Mint Sodium Fluoride MOUTHWASH ORAL 20120316 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .2 mg/mL 42002-443_12e5c419-a8d1-40ac-8745-2e15a547f083 42002-443 HUMAN OTC DRUG Listerine Total Care Zero FreshMint Sodium Fluoride MOUTHWASH ORAL 20110501 20160801 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .221 g/mL 42002-445_a5d4c1c4-d220-45e1-a57e-2aa78facde5a 42002-445 HUMAN OTC DRUG Listerine Naturals Anticavity - Herbal Mint Sodium Fluoride MOUTHWASH ORAL 20131220 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .1 mg/mL 42002-446_4c0f628d-6b02-415c-b9db-9a22309e6bcf 42002-446 HUMAN OTC DRUG Listerine Naturals Antiseptic - Herbal Mint Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20131215 OTC MONOGRAPH NOT FINAL part356 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42002-447_299f327b-49e4-4a54-a226-263935a85a3a 42002-447 HUMAN OTC DRUG Listerine Ultraclean Antiseptic Cool Mint Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20120709 OTC MONOGRAPH NOT FINAL part356 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42002-448_fa7826c1-e40d-44e4-a7f8-7a930c85338d 42002-448 HUMAN OTC DRUG Listerine Ultraclean Antiseptic Arctic Mint Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20120703 OTC MONOGRAPH NOT FINAL part356 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42002-449_3b9f950e-31cf-4acc-8275-d96ee100a7ef 42002-449 HUMAN OTC DRUG Listerine Ultraclean Antiseptic Fresh Citrus Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20120710 OTC MONOGRAPH FINAL part356 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42002-450_82946dc2-e2c4-4c66-ac0e-1a8a77c7f0ef 42002-450 HUMAN OTC DRUG Listerine Fluoride Defense Sodium Fluoride MOUTHWASH ORAL 20120816 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .02 mg/mL 42002-504_29c3a504-6641-4f6f-8c14-d19cf4ef627e 42002-504 HUMAN OTC DRUG Tucks Fast Relief Pramoxine Hydrochloride SPRAY TOPICAL 20120417 OTC MONOGRAPH FINAL part346 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. PRAMOXINE HYDROCHLORIDE 10 mg/mL 42002-506_db97bb8c-3f73-4990-8754-6d45c3012312 42002-506 HUMAN OTC DRUG Listerine Smart Rinse Bubble Gum Shield Sodium Fluoride MOUTHWASH ORAL 20120725 OTC MONOGRAPH NOT FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .221 g/mL 42002-507_294f0577-fcf6-452a-ae86-2d141476b04e 42002-507 HUMAN OTC DRUG Listerine Total Care Zero Fresh Mint Sodium Fluoride MOUTHWASH ORAL 20120725 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .1 mg/mL 42002-509_90b05b77-9af1-4079-85e2-9c4446f16079 42002-509 HUMAN OTC DRUG Listerine Whitening Anticavity Vibrant - Clean Mint Sodium Fluoride MOUTHWASH ORAL 20131215 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .1 mg/mL 42002-512_66752d10-1cc9-47eb-885f-d7946aaa79cd 42002-512 HUMAN OTC DRUG Listerine HealthyWhite Restoring Clean Mint Sodium Fluoride MOUTHWASH ORAL 20140903 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .1 mg/mL 42002-514_4d7527b1-7eca-4783-bfde-0ecb89109171 42002-514 HUMAN OTC DRUG Listerine HealthyWhite Anticavity Mouthrinse Vibrant - Clean Mint Sodium Fluoride MOUTHWASH ORAL 20140728 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .1 mg/mL 42002-516_932e3be2-35a0-4f69-9aae-b70c3f08c57d 42002-516 HUMAN OTC DRUG Listerine Healthy White Anticavity Mouthrinse Gentle Clean Mint Sodium Fluoride MOUTHWASH ORAL 20140624 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .1 mg/mL 42002-616_3b45e44c-2ea8-4218-b46a-1664960b7f71 42002-616 HUMAN OTC DRUG Rembrandt Deeply White Plus Peroxide Whitening Winter Mint Sodium Monofluorophosphate PASTE, DENTIFRICE ORAL 20120316 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g 42002-617_4ef0d817-52bc-4206-8f24-1077369df8c4 42002-617 HUMAN OTC DRUG Rembrandt Deeply White Plus Peroxide Whitening Fresh Mint Sodium Monofluorophosphate PASTE, DENTIFRICE ORAL 20120316 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g 42002-618_6fbe4e51-01e4-4a8c-88fd-34ad1821602a 42002-618 HUMAN OTC DRUG Listerine SmartRinse Anticavity Fluoride Rinse Avengers Sodium Fluoride MOUTHWASH ORAL 20140512 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .1 mg/mL 42002-619_dedc000f-66ab-4428-9e4d-6d86f339f480 42002-619 HUMAN OTC DRUG Listerine Smart Anticavity - Frozen Bubble Blast Sodium Fluoride MOUTHWASH ORAL 20141007 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .1 mg/mL 42021-030_22c80db8-d103-43a9-9e5b-e3932201b294 42021-030 HUMAN OTC DRUG Clean Acne Salicylic Acid GEL TOPICAL 20141207 OTC MONOGRAPH FINAL part333D Ceela Naturals SALICYLIC ACID 20 mg/mL 42023-104_4bcb0731-ce57-45a7-a776-1802e7273fa2 42023-104 HUMAN PRESCRIPTION DRUG Aplisol tuberculin purified protein derivative INJECTION INTRADERMAL 20080207 BLA BLA001781 JHP Pharmaceuticals LLC TUBERCULIN PURIFIED PROTEIN DERIVATIVE 5 [iU]/.1mL Skin Test Antigen [EPC],Tuberculosis Skin Test [EPC],Cell-mediated Immunity [PE],Antigens, Bacterial [Chemical/Ingredient] 42023-105_c8520114-7a8b-468c-8606-27afa3c7bc25 42023-105 HUMAN PRESCRIPTION DRUG Brevital Sodium methohexital sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; RECTAL 20071101 NDA NDA011559 Par Pharmaceutical, Inc. METHOHEXITAL SODIUM 500 mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] CIV 42023-106_c8520114-7a8b-468c-8606-27afa3c7bc25 42023-106 HUMAN PRESCRIPTION DRUG Brevital Sodium methohexital sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; RECTAL 20071101 NDA NDA011559 Par Pharmaceutical, Inc. METHOHEXITAL SODIUM 2.5 g/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] CIV 42023-107_d5e27b02-6369-4e73-a45e-27b07be53b23 42023-107 HUMAN PRESCRIPTION DRUG Coly-Mycin M colistimethate INJECTION INTRAMUSCULAR; INTRAVENOUS 20071101 NDA NDA050108 JHP Pharmaceuticals LLC COLISTIMETHATE SODIUM 150 mg/2mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 42023-108_40e80b61-c198-479e-ab0a-0975d9014139 42023-108 HUMAN PRESCRIPTION DRUG Coly-Mycin S colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate SUSPENSION AURICULAR (OTIC) 20071101 NDA NDA050356 JHP Pharmaceuticals LLC COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE 3; 10; 3.3; .5 mg/mL; mg/mL; mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42023-109_d3c70ef1-0cdc-4995-affd-ee97fe00abc7 42023-109 HUMAN PRESCRIPTION DRUG Cortisporin-TC colistin sulfate, neomycin sulfate, thonzonium bromide, and hydrocortisone acetate SUSPENSION AURICULAR (OTIC) 20071101 NDA NDA050356 JHP Pharmaceuticals LLC COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE 3; 10; 3.3; .5 mg/mL; mg/mL; mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42023-110_b35b8ad4-eaab-4616-bace-696ff678df57 42023-110 HUMAN PRESCRIPTION DRUG Delestrogen estradiol valerate INJECTION INTRAMUSCULAR 20071101 NDA NDA009402 Par Pharmaceutical Inc. ESTRADIOL VALERATE 10 mg/mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 42023-111_b35b8ad4-eaab-4616-bace-696ff678df57 42023-111 HUMAN PRESCRIPTION DRUG Delestrogen estradiol valerate INJECTION INTRAMUSCULAR 20071101 NDA NDA009402 Par Pharmaceutical Inc. ESTRADIOL VALERATE 20 mg/mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 42023-112_b35b8ad4-eaab-4616-bace-696ff678df57 42023-112 HUMAN PRESCRIPTION DRUG Delestrogen estradiol valerate INJECTION INTRAMUSCULAR 20071101 NDA NDA009402 Par Pharmaceutical Inc. ESTRADIOL VALERATE 40 mg/mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 42023-113_6c66bca5-b3c2-45a8-a00f-c98bf563d4c1 42023-113 HUMAN PRESCRIPTION DRUG Ketalar ketamine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20071001 NDA NDA016812 JHP Pharmaceuticals LLC KETAMINE HYDROCHLORIDE 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII 42023-114_6c66bca5-b3c2-45a8-a00f-c98bf563d4c1 42023-114 HUMAN PRESCRIPTION DRUG Ketalar ketamine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20071001 NDA NDA016812 JHP Pharmaceuticals LLC KETAMINE HYDROCHLORIDE 50 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII 42023-115_6c66bca5-b3c2-45a8-a00f-c98bf563d4c1 42023-115 HUMAN PRESCRIPTION DRUG Ketalar ketamine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20071001 NDA NDA016812 JHP Pharmaceuticals LLC KETAMINE HYDROCHLORIDE 100 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII 42023-116_f79ba935-369b-4280-9d87-345f6bd59b20 42023-116 HUMAN PRESCRIPTION DRUG Pitocin oxytocin INJECTION INTRAVENOUS 20071001 NDA NDA018261 JHP Pharmaceuticals LLC OXYTOCIN 10 [iU]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 42023-117_a204c571-3db2-4209-8a2a-64c2f863640d 42023-117 HUMAN PRESCRIPTION DRUG Pitressin vasopressin INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20071001 20160630 UNAPPROVED DRUG OTHER Par Pharmaceutical, Inc. VASOPRESSIN, UNSPECIFIED 20 [USP&apos'U]/mL 42023-118_5b1a4eac-0666-43ec-9ee7-e449bb963af7 42023-118 HUMAN PRESCRIPTION DRUG Tigan trimethobenzamide hydrochloride INJECTION INTRAMUSCULAR 20071101 NDA NDA017530 JHP Pharmaceuticals LLC TRIMETHOBENZAMIDE HYDROCHLORIDE 100 mg/mL Antiemetic [EPC],Emesis Suppression [PE] 42023-119_5b1a4eac-0666-43ec-9ee7-e449bb963af7 42023-119 HUMAN PRESCRIPTION DRUG Tigan trimethobenzamide hydrochloride INJECTION INTRAMUSCULAR 20071101 NDA NDA017530 JHP Pharmaceuticals LLC TRIMETHOBENZAMIDE HYDROCHLORIDE 100 mg/mL Antiemetic [EPC],Emesis Suppression [PE] 42023-120_83df2159-5b86-4a6e-925f-ecab4a677a44 42023-120 HUMAN PRESCRIPTION DRUG Triostat liothyronine sodium INJECTION INTRAVENOUS 20071001 NDA NDA020105 JHP Pharmaceuticals LLC LIOTHYRONINE SODIUM 10 ug/mL l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 42023-121_602f8636-913b-4686-9f3f-b625b44b7a89 42023-121 HUMAN PRESCRIPTION DRUG sumatriptan succinate sumatriptan succinate INJECTION SUBCUTANEOUS 20090806 ANDA ANDA077871 JHP Pharmaceuticals LLC SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 42023-123_b226368d-4857-4e76-b4c9-58be7eddedfd 42023-123 HUMAN PRESCRIPTION DRUG Dantrium dantrolene sodium INJECTION INTRAVENOUS 20080801 NDA NDA018264 Par Pharmaceutical, Inc. DANTROLENE SODIUM 20 mg/60mL Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] 42023-124_ddfaaf61-fe76-44f3-9893-a6c04ecacbce 42023-124 HUMAN PRESCRIPTION DRUG Dantrium dantrolene sodium CAPSULE ORAL 20080801 NDA NDA017443 JHP Pharmaceuticals LLC DANTROLENE SODIUM 25 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] 42023-125_ddfaaf61-fe76-44f3-9893-a6c04ecacbce 42023-125 HUMAN PRESCRIPTION DRUG Dantrium dantrolene sodium CAPSULE ORAL 20080801 NDA NDA017443 JHP Pharmaceuticals LLC DANTROLENE SODIUM 50 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] 42023-126_ddfaaf61-fe76-44f3-9893-a6c04ecacbce 42023-126 HUMAN PRESCRIPTION DRUG Dantrium dantrolene sodium CAPSULE ORAL 20080801 NDA NDA017443 JHP Pharmaceuticals LLC DANTROLENE SODIUM 100 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] 42023-129_7ba0de6e-7903-41a4-9ad5-03bb50cc7876 42023-129 HUMAN PRESCRIPTION DRUG Fluphenazine Decanoate Fluphenazine Decanoate INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20140709 ANDA ANDA203732 Par Pharmaceutical, Inc. FLUPHENAZINE DECANOATE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 42023-130_e313fdb0-2061-4319-a64d-50fda2b628e4 42023-130 HUMAN PRESCRIPTION DRUG Pitocin oxytocin INJECTION INTRAVENOUS 20120905 NDA NDA018261 JHP Pharmaceuticals LLC OXYTOCIN 10 [iU]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 42023-131_00a2d319-ab97-45d6-a8b9-b671c9d6bae6 42023-131 HUMAN PRESCRIPTION DRUG Colistimethate colistimethate sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 20120601 NDA AUTHORIZED GENERIC NDA050108 JHP Pharmaceuticals, LLC COLISTIMETHATE SODIUM 150 mg/2mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 42023-134_6cac809d-0040-4cac-aa03-f45015cef998 42023-134 HUMAN PRESCRIPTION DRUG Estradiol Valerate estradiol valerate INJECTION INTRAMUSCULAR 20120601 NDA AUTHORIZED GENERIC NDA009402 JHP Pharmaceuticals, LLC ESTRADIOL VALERATE 10 mg/mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 42023-135_6cac809d-0040-4cac-aa03-f45015cef998 42023-135 HUMAN PRESCRIPTION DRUG Estradiol Valerate estradiol valerate INJECTION INTRAMUSCULAR 20120601 NDA AUTHORIZED GENERIC NDA009402 JHP Pharmaceuticals, LLC ESTRADIOL VALERATE 20 mg/mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 42023-136_6cac809d-0040-4cac-aa03-f45015cef998 42023-136 HUMAN PRESCRIPTION DRUG Estradiol Valerate estradiol valerate INJECTION INTRAMUSCULAR 20120601 NDA AUTHORIZED GENERIC NDA009402 JHP Pharmaceuticals, LLC ESTRADIOL VALERATE 40 mg/mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 42023-137_d770ab0f-3a39-4d7b-b03c-a13897ef8a34 42023-137 HUMAN PRESCRIPTION DRUG ketamine hydrochloride ketamine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20120601 NDA AUTHORIZED GENERIC NDA016812 JHP Pharmaceuticals, LLC KETAMINE HYDROCHLORIDE 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII 42023-138_d770ab0f-3a39-4d7b-b03c-a13897ef8a34 42023-138 HUMAN PRESCRIPTION DRUG ketamine hydrochloride ketamine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20120601 NDA AUTHORIZED GENERIC NDA016812 JHP Pharmaceuticals, LLC KETAMINE HYDROCHLORIDE 50 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII 42023-139_d770ab0f-3a39-4d7b-b03c-a13897ef8a34 42023-139 HUMAN PRESCRIPTION DRUG ketamine hydrochloride ketamine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20120601 NDA AUTHORIZED GENERIC NDA016812 JHP Pharmaceuticals, LLC KETAMINE HYDROCHLORIDE 100 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII 42023-140_a4b55d76-b61d-4c94-b04a-2152ee57476b 42023-140 HUMAN PRESCRIPTION DRUG Oxytocin oxytocin INJECTION INTRAVENOUS 20120601 NDA AUTHORIZED GENERIC NDA018261 JHP Pharmaceuticals, LLC OXYTOCIN 10 [iU]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 42023-141_a4b55d76-b61d-4c94-b04a-2152ee57476b 42023-141 HUMAN PRESCRIPTION DRUG Oxytocin oxytocin INJECTION INTRAVENOUS 20120601 NDA AUTHORIZED GENERIC NDA018261 JHP Pharmaceuticals, LLC OXYTOCIN 10 [iU]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 42023-142_1f95d281-62ad-4a01-be68-8512e47029fe 42023-142 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride trimethobenzamide hydrochloride INJECTION INTRAMUSCULAR 20120601 NDA AUTHORIZED GENERIC NDA017530 JHP Pharmaceuticals, LLC TRIMETHOBENZAMIDE HYDROCHLORIDE 100 mg/mL Antiemetic [EPC],Emesis Suppression [PE] 42023-143_1f95d281-62ad-4a01-be68-8512e47029fe 42023-143 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride trimethobenzamide hydrochloride INJECTION INTRAMUSCULAR 20120601 NDA AUTHORIZED GENERIC NDA017530 JHP Pharmaceuticals, LLC TRIMETHOBENZAMIDE HYDROCHLORIDE 100 mg/mL Antiemetic [EPC],Emesis Suppression [PE] 42023-144_441981cc-0556-441e-99dc-b90b438ea1e6 42023-144 HUMAN PRESCRIPTION DRUG dantrolene sodium dantrolene sodium CAPSULE ORAL 20130408 NDA AUTHORIZED GENERIC NDA017443 JHP Pharmaceuticals, LLC DANTROLENE SODIUM 25 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] 42023-145_441981cc-0556-441e-99dc-b90b438ea1e6 42023-145 HUMAN PRESCRIPTION DRUG dantrolene sodium dantrolene sodium CAPSULE ORAL 20130408 NDA AUTHORIZED GENERIC NDA017443 JHP Pharmaceuticals, LLC DANTROLENE SODIUM 50 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] 42023-146_02a1aad2-131e-415a-bd57-5df2000c7c48 42023-146 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride Dexmedetomidine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140819 ANDA ANDA203972 Par Pharmaceutical, Inc. DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] 42023-151_a697201c-b754-42c3-8acd-2620ea306e11 42023-151 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130304 ANDA ANDA091170 JHP Pharmaceuticals, LLC. ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 42023-159_0263db0d-aeee-4258-88a7-3ae98d62f068 42023-159 HUMAN PRESCRIPTION DRUG Adrenalin epinephrine INJECTION INTRAMUSCULAR; INTRAOCULAR; SUBCUTANEOUS 20130701 NDA NDA204200 JHP Pharmaceuticals LLC EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 42023-163_c63abe33-8ad4-416f-9a8b-1be4d38aa400 42023-163 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION INTRAVENOUS 20130805 ANDA ANDA202163 JHP Pharmaceuticals, LLC. ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 42023-164_e1bc7c2b-a536-49a4-97e4-dfac673f393b 42023-164 HUMAN PRESCRIPTION DRUG Vasostrict Vasopressin INJECTION INTRAVENOUS 20141112 NDA NDA204485 Par Pharmaceutical, Inc. VASOPRESSIN, UNSPECIFIED 20 [USP&apos'U]/mL 42023-167_7133e3cf-682e-4098-867b-66a9185e5c88 42023-167 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130507 ANDA ANDA202571 JHP Pharmaceuticals, LLC. ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 42023-168_0263db0d-aeee-4258-88a7-3ae98d62f068 42023-168 HUMAN PRESCRIPTION DRUG Adrenalin epinephrine INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20140301 NDA NDA204640 JHP Pharmaceuticals LLC EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 42023-169_9c2883df-b26c-44d9-a9e3-0ca56ff0ae68 42023-169 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION, SOLUTION INTRAVENOUS 20140904 ANDA ANDA091297 Par Pharmaceutical, Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 42023-170_9c2883df-b26c-44d9-a9e3-0ca56ff0ae68 42023-170 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION, SOLUTION INTRAVENOUS 20140624 ANDA ANDA091297 Par Pharmaceutical, Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 42043-130_220469c4-fa27-4460-b964-974c1015f1bc 42043-130 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET, FILM COATED ORAL 20121212 ANDA ANDA091441 OrchidPharma Inc NARATRIPTAN HYDROCHLORIDE 1 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 42043-131_220469c4-fa27-4460-b964-974c1015f1bc 42043-131 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET, FILM COATED ORAL 20121212 ANDA ANDA091441 OrchidPharma Inc NARATRIPTAN HYDROCHLORIDE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 42043-140_807fbe52-7a3f-4426-b9d3-8e0cee23e46a 42043-140 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20071212 ANDA ANDA065248 Karalex Pharma LLC CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42043-141_807fbe52-7a3f-4426-b9d3-8e0cee23e46a 42043-141 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20080118 ANDA ANDA065248 Karalex Pharma LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42043-142_698c4845-9783-4f7e-a52a-15ffaa3d47c2 42043-142 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20070412 ANDA ANDA065326 OrchidPharma Inc CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42043-143_698c4845-9783-4f7e-a52a-15ffaa3d47c2 42043-143 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20070412 ANDA ANDA065326 OrchidPharma Inc CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42043-150_0df554e0-338b-45fa-8c33-279851c271e5 42043-150 HUMAN PRESCRIPTION DRUG Malathion lotion, 0.5% malathion lotion, 0.5% LOTION TOPICAL 20090513 ANDA ANDA078743 Karalex Pharma, LLC, Woodcliff Lake, NJ 07677 MALATHION 5 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 42043-160_3146b41c-64b4-48cd-8df5-62a6c3b21658 42043-160 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20130801 ANDA ANDA078963 OrchidPharma Inc MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 42043-161_3146b41c-64b4-48cd-8df5-62a6c3b21658 42043-161 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20130801 ANDA ANDA078963 OrchidPharma Inc MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 42043-170_5d0a9228-18e6-4bb7-b9e5-58f41fdcb22e 42043-170 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, COATED ORAL 20091120 ANDA ANDA076520 Karalex Pharma LLC FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 42043-171_5d0a9228-18e6-4bb7-b9e5-58f41fdcb22e 42043-171 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, COATED ORAL 20091120 ANDA ANDA076520 Karalex Pharma LLC FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 42043-190_7967f8f4-eba8-4849-a176-944fffa2ee53 42043-190 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110901 ANDA ANDA078526 Karalex Pharma LLC LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42043-191_7967f8f4-eba8-4849-a176-944fffa2ee53 42043-191 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110901 ANDA ANDA078526 Karalex Pharma LLC LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42043-192_7967f8f4-eba8-4849-a176-944fffa2ee53 42043-192 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110901 ANDA ANDA078526 Karalex Pharma LLC LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42043-193_fe7e0c86-8007-4af5-965c-184c6dbce17d 42043-193 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110901 ANDA ANDA090484 Karalex Pharma LLC LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42043-250_2c2cbaba-6b79-4236-981a-7682e0b313b3 42043-250 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20140704 ANDA ANDA065418 OrchidPharma Inc CEFDINIR MONOHYDRATE 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42043-251_a6fb996c-017c-4aa6-84c4-c6625d398eb1 42043-251 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20131004 ANDA ANDA065429 OrchidPharma Inc CEFDINIR MONOHYDRATE 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42043-252_a6fb996c-017c-4aa6-84c4-c6625d398eb1 42043-252 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20131004 ANDA ANDA065429 OrchidPharma Inc CEFDINIR MONOHYDRATE 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42043-320_6e6bf9c6-228b-48a8-a75e-64eae228f9bb 42043-320 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140925 ANDA ANDA091113 OrchidPharma Inc ESZOPICLONE 1 mg/1 CIV 42043-321_6e6bf9c6-228b-48a8-a75e-64eae228f9bb 42043-321 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140925 ANDA ANDA091113 OrchidPharma Inc ESZOPICLONE 2 mg/1 CIV 42043-322_6e6bf9c6-228b-48a8-a75e-64eae228f9bb 42043-322 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140925 ANDA ANDA091113 OrchidPharma Inc ESZOPICLONE 3 mg/1 CIV 42046-002_3a805223-101e-4b49-9a6f-a77b127d5d51 42046-002 HUMAN OTC DRUG Arneu Camphor Menthol CREAM TOPICAL 20100828 OTC MONOGRAPH FINAL part341 CC Medical Devices Inc CAMPHOR (NATURAL); MENTHOL 3.1; 3 g/100g; g/100g 42068-001_1f313208-956c-4fa6-91ad-1fcbe16ad0b1 42068-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19730101 UNAPPROVED MEDICAL GAS Jackson Welding Supply Co Inc. OXYGEN 990 mL/L 42068-002_4a64ccba-298d-4900-95fe-d649adb434e1 42068-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19730101 UNAPPROVED MEDICAL GAS Jackson Welding Supply Co Inc. NITROGEN 990 mL/L 42086-101_796ced8d-3a21-46bc-8d1e-147cc704bbd0 42086-101 HUMAN OTC DRUG Good to Go Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130427 OTC MONOGRAPH NOT FINAL part333E Jiangsu Gold Worldworks Household Chemicals Co., Ltd. ALCOHOL 62 mL/100mL 42126-5200_ae5734e7-bb02-4cfc-81ae-6b05dd4422fe 42126-5200 HUMAN OTC DRUG VISCO SHIELD Lubricant HYPROMELLOSE 2208 (15000 MPA.S) SOLUTION/ DROPS OPHTHALMIC 20140616 OTC MONOGRAPH FINAL part349 OASIS Medical, Inc. HYPROMELLOSE 2208 (15000 MPA.S) 17 mg/mL 42126-6100_97d84a3b-1045-4ecb-a14c-c25f75cc9bbe 42126-6100 HUMAN OTC DRUG OASIS Tears Glycerin SOLUTION/ DROPS OPHTHALMIC 20071101 OTC MONOGRAPH FINAL part349 OASIS Medical, Inc. GLYCERIN .2 g/100mL 42126-6200_c578028b-e30d-4a33-b7cf-e13b5a45b92c 42126-6200 HUMAN OTC DRUG OASIS Tears Plus Glycerin SOLUTION/ DROPS OPHTHALMIC 20071101 OTC MONOGRAPH FINAL part349 OASIS Medical, Inc. GLYCERIN .2 g/100mL 42126-6310_cd2cc97d-dad2-44d8-a590-ac51490705a7 42126-6310 HUMAN OTC DRUG OASIS Tears Multidose Glycerin SOLUTION/ DROPS OPHTHALMIC 20100901 OTC MONOGRAPH FINAL part349 OASIS Medical, Inc. GLYCERIN 2 g/1000mL 42139-001_01bc6361-db87-4c02-b0de-ac1dbfe7fbab 42139-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19880101 UNAPPROVED MEDICAL GAS Seaboard Welding Supply Co., Inc. OXYGEN 99 L/100L 42165-0001_df9822b4-05fb-4ae7-b9af-64f834d1933f 42165-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070101 UNAPPROVED MEDICAL GAS Atlanta Medical Gas LLC OXYGEN 99 L/100L 42165-0002_df9822b4-05fb-4ae7-b9af-64f834d1933f 42165-0002 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20070101 UNAPPROVED MEDICAL GAS Atlanta Medical Gas LLC OXYGEN 99 L/100L 42192-101_6ac70026-fae6-4259-8854-8fe97a57b57a 42192-101 HUMAN PRESCRIPTION DRUG UREA UREA EMULSION TOPICAL 20101108 UNAPPROVED DRUG OTHER ACELLA PHARMACEUTICALS UREA 50 g/100g 42192-103_6ab99d12-03a6-478e-b976-0a8031d94dcc 42192-103 HUMAN PRESCRIPTION DRUG BP Cleansing Wash SODIUM SULFACETAMIDE and SULFUR LIQUID TOPICAL 20080208 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 100; 40 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42192-104_8da300bc-834c-4814-a799-b9ebc9056d8d 42192-104 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE and SULFUR Wash SODIUM SULFACETAMIDE and SULFUR LIQUID TOPICAL 20080208 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 100; 10 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42192-105_13b45320-6394-47c3-b97d-8a0d2cdd34a9 42192-105 HUMAN OTC DRUG BPO benzoyl peroxide GEL TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333D Acella Pharmaceuticals, LLC BENZOYL PEROXIDE 4 mg/100mg 42192-106_b006ce8f-47a7-4df9-a282-0f0c4bbedaf5 42192-106 HUMAN OTC DRUG BPO benzoyl peroxide GEL TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333D Acella Pharmaceuticals, LLC BENZOYL PEROXIDE 8 mg/100mg 42192-108_cfabcb14-e037-450a-ae1f-ab93b11c8776 42192-108 HUMAN PRESCRIPTION DRUG Acella Hydrocortisone Acetate - Pramoxine Singles HYDROCORTISONE ACETATE, PRAMOXINE CREAM TOPICAL 20101108 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC HYDROCORTISONE ACETATE; PRAMOXINE 2.5; 1 g/100g; g/100g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42192-109_50a0add2-6616-41e8-8a0c-af98a6c73e5a 42192-109 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate and Pramoxine Hydrochloride Hydrocortisone Acetate and Pramoxine Hydrochloride CREAM TOPICAL 20081103 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 10; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42192-110_4fee6a52-b2fa-4456-9104-b2c031a3374c 42192-110 HUMAN OTC DRUG BPO Creamy Wash Complete Pack BENZOYL PEROXIDE KIT 20110927 OTC MONOGRAPH FINAL part333D Acella Pharmaceuticals, LLC 42192-111_c50e4101-c596-4b43-be65-dac3b98516be 42192-111 HUMAN OTC DRUG BPO Creamy Wash Complete Pack BENZOYL PEROXIDE KIT 20090819 OTC MONOGRAPH FINAL part333D Acella Pharmaceuticals, LLC 42192-112_9661ef5a-03cc-4d24-a764-ec2c8a9163df 42192-112 HUMAN PRESCRIPTION DRUG SALICYLIC ACID SALICYLIC ACID AEROSOL, FOAM TOPICAL 20100716 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SALICYLIC ACID 6 g/100g 42192-113_15c56071-3f65-4b1f-8d9b-b59dfd66cbfe 42192-113 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE - SULFUR CLEANSING PADS SODIUM SULFACETAMIDE, SULFUR SWAB TOPICAL 20100916 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 10; 4 g/100g; g/100g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42192-115_d694ff1b-66fe-4099-9acf-b14169bd47b2 42192-115 HUMAN PRESCRIPTION DRUG UREA HYDRATING TOPICAL UREA AEROSOL, FOAM TOPICAL 20101109 UNAPPROVED DRUG OTHER Acella Pharmaceuticals UREA 35 g/100g 42192-118_0ea2ac12-fd45-447b-a5c3-67581a9c48f7 42192-118 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate and Pramoxine Hydrochloride Hydrocortisone Acetate and Pramoxine Hydrochloride KIT 20100201 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC 42192-119_c3eb0ff9-799b-49a2-8369-a91fe751821a 42192-119 HUMAN PRESCRIPTION DRUG hydrocortisone acetate pramoxine hcl hydrocortisone acetate pramoxine hcl KIT 20100201 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC 42192-121_bfd99a0b-c88c-4b98-854e-8d1310b1a2d6 42192-121 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE - SULFUR WASH SODIUM SULFACETAMIDE, SULFUR LIQUID TOPICAL 20100916 UNAPPROVED DRUG OTHER ACELLA PHARMACEUTICALS SULFACETAMIDE; SULFUR 90; 40 mg/473.2mL; mg/473.2mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42192-124_fa6d2031-f4db-4d10-811b-e54e78652659 42192-124 HUMAN PRESCRIPTION DRUG BPO 3 Foaming BENZOYL PEROXIDE CLOTH TOPICAL 20100818 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC BENZOYL PEROXIDE 3.2 g/100g 42192-125_504b9718-9366-4ae8-b349-fdb18b084dde 42192-125 HUMAN PRESCRIPTION DRUG BPO 6 Foaming BENZOYL PEROXIDE CLOTH TOPICAL 20100818 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC BENZOYL PEROXIDE 3.2 g/100g 42192-128_a28d24fe-9ec4-4e13-a141-86bb3e5f89a2 42192-128 HUMAN PRESCRIPTION DRUG BPO 9 Foaming BENZOYL PEROXIDE CLOTH TOPICAL 20100818 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC BENZOYL PEROXIDE 9 g/100g 42192-129_77671f48-b574-490f-a1c2-b321af8dac52 42192-129 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE SODIUM SULFACETAMIDE LIQUID TOPICAL 20101214 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42192-130_ce96e7b2-772b-4196-9039-484e823fbd0f 42192-130 HUMAN PRESCRIPTION DRUG SALICYLIC ACID SALICYLIC ACID AEROSOL, FOAM TOPICAL 20110427 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SALICYLIC ACID 6 g/100g 42192-133_c3ff4716-6009-4e29-9da9-ea740726cc3c 42192-133 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide and Sulfur Sodium Sulfacetamide and Sulfur SOLUTION TOPICAL 20110727 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 80; 40 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42192-134_996ad0d5-d635-4ed4-8263-d7f773260421 42192-134 HUMAN PRESCRIPTION DRUG Salicylic Acid SALICYLIC ACID GEL TOPICAL 20110519 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SALICYLIC ACID 60 mg/g 42192-135_572171f7-832f-4710-b888-eef5638fc9d4 42192-135 HUMAN PRESCRIPTION DRUG SALICYLIC ACID SALICYLIC ACID LIQUID TOPICAL 20110921 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SALICYLIC ACID 275 mg/mL 42192-136_1926eadd-d11f-44fa-971f-0041060f7589 42192-136 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 10 Sulfur 5 Cleanser Sulfacetamide Sodium and Sulfur RINSE TOPICAL 20100916 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 10; 5 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42192-138_eab3f887-e137-49a1-aa85-1ebe634065f7 42192-138 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 10 Sulfur 5 Sulfacetamide Sodium and Sulfur CLOTH TOPICAL 20110208 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42192-139_99705c54-b7af-423d-8f20-881e8fea236f 42192-139 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE, SULFUR Sodium Sulfacetamide and Sulfur CREAM TOPICAL 20110727 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42192-144_a761feea-86b6-44f0-8f9a-50d29ebb60e9 42192-144 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 9 Sulfur 4.5 Wash Sulfacetamide Sodium and Sulfur RINSE TOPICAL 20110720 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 9; 4.5 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42192-146_18bad170-4489-4878-a83c-f2736c2d34b9 42192-146 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide Sodium Sulfacetamide GEL TOPICAL 20101214 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42192-147_210774a9-aaab-4bd4-ac5a-481ed72e0c0c 42192-147 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 10 Sulfur 2 Cleanser Sulfacetamide Sodium and Sulfur SOLUTION TOPICAL 20080208 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 100; 20 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42192-149_99705c54-b7af-423d-8f20-881e8fea236f 42192-149 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE, SULFUR Sodium Sulfacetamide and Sulfur CREAM TOPICAL 20110727 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42192-150_a57b734d-5d6d-4cd7-8003-9174cc785e41 42192-150 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 10 Sulfur 2 cream Sulfacetamide Sodium and Sulfur CREAM TOPICAL 20080208 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 100; 20 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42192-151_595dfc50-ee6f-41b5-ab5b-4c293aee342b 42192-151 HUMAN PRESCRIPTION DRUG HYDROQUINONE 4% Hydroquinone CREAM TOPICAL 20110117 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 42192-320_9f4ce551-7a80-4ddb-a014-95c44b54a420 42192-320 HUMAN PRESCRIPTION DRUG PNV-Select VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE and CUPRIC OXIDE, TABLET, FILM COATED ORAL 20091102 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE 10; 80; 300; 120; 6; 400; 2; 12; 27; 1; 30; 20; 150; 20; 3.4; 3; 2500; 15 [iU]/1; mg/1; ug/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; [iU]/1; ug/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 42192-321_038fe2e7-dc16-485c-b5fb-746db7231347 42192-321 HUMAN PRESCRIPTION DRUG PNV-DHA ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, magnesium, doconexent CAPSULE, GELATIN COATED ORAL 20091102 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CALCIUM; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; PYRIDOXINE 10; 85; 140; 200; 12; 300; 27; 1; 45; 25 [iU]/1; [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 42192-329_3dff2a17-c907-4e46-b6bd-f6ff40292af4 42192-329 HUMAN PRESCRIPTION DRUG NP Thyroid 30 LEVOTHYROXINE, LIOTHYRONINE TABLET TOPICAL 20101111 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC LEVOTHYROXINE; LIOTHYRONINE 19; 4.5 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 42192-330_ebfa540a-1ce7-4f33-8343-65121e23c401 42192-330 HUMAN PRESCRIPTION DRUG NP Thyroid 60 LEVOTHYROXINE, LIOTHYRONINE TABLET TOPICAL 20101111 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC LEVOTHYROXINE; LIOTHYRONINE 38; 9 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 42192-331_771d13d3-b76b-4cbc-a096-991e06796c90 42192-331 HUMAN PRESCRIPTION DRUG NP Thyroid 90 LEVOTHYROXINE, LIOTHYRONINE TABLET TOPICAL 20101111 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC LEVOTHYROXINE; LIOTHYRONINE 57; 13.5 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 42192-336_491ffe0a-a8a0-43da-b2f8-5b1a59c70a45 42192-336 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride And Clidinium Bromide CHLORDIAZEPOXIDE HYDROCHLORIDE, CLIDINIUM BROMIDE CAPSULE ORAL 20110830 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] CIV 42192-341_7240d5fb-cb2d-4278-988f-c8e6bba6560d 42192-341 HUMAN PRESCRIPTION DRUG Prenaissance CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM and DOCONEXENT CAPSULE, LIQUID FILLED ORAL 20110519 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC .ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; TRICALCIUM PHOSPHATE 30; 28; 800; 325; 55; 29; 1.25; 25; 160 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 42192-343_1459ccd1-2372-450f-ac17-382ca9a5b175 42192-343 HUMAN PRESCRIPTION DRUG Prenaissance Plus CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM and DOCONEXENT CAPSULE, LIQUID FILLED ORAL 20110912 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; CALCIUM CITRATE; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON PENTACARBONYL; PYRIDOXINE HYDROCHLORIDE 30; 100; 400; 250; 50; 1; 28; 25 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 42192-350_30b14bbd-37cf-44c5-89c6-cdf8c7ded7c5 42192-350 HUMAN PRESCRIPTION DRUG PNV-First .beta.-carotene, cholecalciferol, ascorbic acid, .alpha.-tocopherol acetate, dl-, folic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, niacinamide, calcium carbonate, ferrous fumarate, magnesium oxide, zinc oxide, cupric oxide and doconexent TABLET, COATED ORAL 20130517 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FOLIC ACID; IRON SUCROSE; MAGNESIUM OXIDE; NIACINAMIDE; OMEGA-3 FATTY ACIDS; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 20; 1100; 30; 1000; 2; 12; 1; 29; 20; 15; 200; 150; 2.5; 1.8; 1.6; 25 [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 42192-352_0278a8ed-b74a-44ce-8d8b-e9cdf19b953b 42192-352 HUMAN PRESCRIPTION DRUG PNV-OB-DHA .beta.-carotene, cholecalciferol, ascorbic acid, .alpha.-tocopherol acetate, dl-, folic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, niacinamide, calcium carbonate, ferrous fumarate, magnesium oxide, zinc oxide, cupric oxide and doconexent KIT 20130517 20150531 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC 42192-353_23baa821-7703-4523-99ca-ffd57a0beb14 42192-353 HUMAN PRESCRIPTION DRUG Choice OB DHA .beta.-carotene, cholecalciferol, ascorbic acid, .alpha.-tocopherol acetate, dl-, folic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, niacinamide, calcium carbonate, ferrous fumarate, magnesium oxide, zinc oxide, cupric oxide and doconexent KIT 20130517 20150731 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC 42192-365_abb9570f-3866-4f6c-befc-2ca9f1f0902b 42192-365 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20110516 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SALSALATE 500 mg/1 42192-366_abb9570f-3866-4f6c-befc-2ca9f1f0902b 42192-366 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20110516 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SALSALATE 750 mg/1 42192-514_400c0464-0084-419c-9b6a-ce86ead2b695 42192-514 HUMAN PRESCRIPTION DRUG Entre-S Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride and Chlorpheniramine Maleate SYRUP ORAL 20091215 OTC MONOGRAPH FINAL part341 Brookstone Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 30; 30 mg/5mL; mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 42192-520_6eaf0913-2d56-45d7-a430-47d9c1792e84 42192-520 HUMAN PRESCRIPTION DRUG QUADRAPAX Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide ELIXIR ORAL 20110506 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] CIV 42192-521_1089fc64-2296-4c80-a0db-efd50e693a25 42192-521 HUMAN OTC DRUG Pyrilamine-Phenylephrine Pyrilamine Maleate and Phenylephrine Hydrochloride LIQUID ORAL 20120822 OTC MONOGRAPH FINAL part341 Acella Pharmaceuticals, LLC PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE 5; 16 mg/5mL; mg/5mL 42192-523_1d253b18-9354-4c22-8859-888e1940935c 42192-523 HUMAN OTC DRUG Entre-Cough Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, Guaifensin LIQUID ORAL 20130204 OTC MONOGRAPH FINAL part341 Acella Pharmaceuticals, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 15; 175; 30 mg/5mL; mg/5mL; mg/5mL 42192-605_2884b04a-27e3-4892-9705-c7f42763db88 42192-605 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20140211 ANDA ANDA202436 Acella Pharmaceuticals TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 42192-608_3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa2 42192-608 HUMAN PRESCRIPTION DRUG Gabapentin gabapentin SOLUTION ORAL 20121001 ANDA ANDA076403 Acella Pharmaceuticals, LLC GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42192-705_814d7c39-a917-43c3-bb6b-efce322607e0 42192-705 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox KIT 20090701 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC 42192-706_9f89cb91-bd3b-4103-a8a1-c1c1512fe514 42192-706 HUMAN PRESCRIPTION DRUG Calcium Folic Acid Plus D Chewable cholecalciferol, magnesium, boron, folic acid, pyridoxine, cyanocobalamin WAFER ORAL 20100323 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC BORON; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; MAGNESIUM; PYRIDOXINE 250; 1342; 300; 125; 1; 50; 10 ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 42192-707_8a0d307f-6f64-4db0-aad3-a59881dcdbd9 42192-707 HUMAN PRESCRIPTION DRUG Urea Urea SOLUTION TOPICAL 20090622 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC UREA 400 mg/g 42192-708_8ed7e206-b72f-4c10-b01a-5fecaa2f9725 42192-708 HUMAN PRESCRIPTION DRUG Antipyrine and Benzocaine Otic ANTIPYRINE, BENZOCAINE SOLUTION AURICULAR (OTIC) 20101109 UNAPPROVED DRUG OTHER Acella Pharmaceuticals ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 42192-710_94853e4e-e83a-4aee-967e-4ec73c926674 42192-710 HUMAN PRESCRIPTION DRUG Acella Antipyrine and Benzocaine Otic ANTIPYRINE, BENZOCAINE SOLUTION AURICULAR (OTIC) 20101109 UNAPPROVED DRUG OTHER Acella Pharmaceuticals ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 42192-712_7ce00087-4c0d-48c5-bf22-a99e207130e7 42192-712 HUMAN PRESCRIPTION DRUG Aurax Otic ANTIPYRINE, BENZOCAINE SOLUTION AURICULAR (OTIC) 20110912 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC ANTIPYRINE; BENZOCAINE 55; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 42192-714_2c67dd09-ab1f-4ccf-97b5-421356f64f22 42192-714 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox KIT 20110912 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC 42195-145_96e5dac4-1745-4961-8c9a-77fdc96b778f 42195-145 HUMAN PRESCRIPTION DRUG Isometheptene Mucate, Caffeine, and Acetaminophen Isometheptene Mucate, Caffeine and Acetaminophen TABLET ORAL 20100601 UNAPPROVED DRUG OTHER Xspire Pharma ACETAMINOPHEN; CAFFEINE; ISOMETHEPTENE MUCATE 325; 20; 65 mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 42195-210_fd6ab993-d4ca-490b-a07c-61b0910ea657 42195-210 HUMAN OTC DRUG Pyrilamine Maleate and Phenylephrine Hydrochloride Pyrilamine Maleate and Phenylephrine Hydrochloride TABLET ORAL 20131028 OTC MONOGRAPH FINAL part341 Xspire Pharma LLC PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE 10; 25 mg/1; mg/1 42195-308_dfc2ab1e-0d75-4eff-9489-2afb51b02702 42195-308 HUMAN PRESCRIPTION DRUG Nalfon fenoprofen calcium CAPSULE ORAL 20120827 NDA NDA017604 Xspire Pharma FENOPROFEN CALCIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42195-550_d0125acf-1879-452d-ba29-c0f753653789 42195-550 HUMAN PRESCRIPTION DRUG Ciprofloxacin Otic CIPROFLOXACIN SOLUTION/ DROPS AURICULAR (OTIC) 20120827 NDA NDA021918 Xspire Pharma CIPROFLOXACIN HYDROCHLORIDE .5 mg/.25mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 42195-600_dfc2ab1e-0d75-4eff-9489-2afb51b02702 42195-600 HUMAN PRESCRIPTION DRUG Nalfon fenoprofen calcium CAPSULE ORAL 20120827 NDA NDA017604 Xspire Pharma FENOPROFEN CALCIUM 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42199-002_ced869ee-565c-4f0c-957c-092b6632dd21 42199-002 HUMAN OTC DRUG Beyond Antiseptic Mouthwash Cetylpyridinium Chloride, Sodium Fluoride LIQUID DENTAL 20071005 OTC MONOGRAPH NOT FINAL part356 BEYOND TECHNOLOGY CORP. CETYLPYRIDINIUM CHLORIDE; SODIUM FLUORIDE .1; .05 mg/mL; mg/mL 42199-005_4b897d6f-13a1-487f-9aa1-1ee48fd787ab 42199-005 HUMAN OTC DRUG Pearl White Potassium nitrate, Sodium fluoride PASTE, DENTIFRICE DENTAL 20071005 OTC MONOGRAPH NOT FINAL part356 BEYOND TECHNOLOGY CORP. POTASSIUM NITRATE; SODIUM FLUORIDE .05; .1 mg/g; mg/g 42209-1995_ce73e41e-2b80-4644-b419-94163a8f2826 42209-1995 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20080901 UNAPPROVED MEDICAL GAS ITC Medical Supplies OXYGEN 99 L/100L 42211-101_01336051-74da-4b96-b543-f84b9ab003c1 42211-101 HUMAN PRESCRIPTION DRUG INDOCIN indomethacin SUSPENSION ORAL 19851010 NDA NDA018332 Iroko Pharmaceuticals, LLC INDOMETHACIN 25 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42211-102_4f53c978-87b9-409c-bf0a-8973a2aa0f00 42211-102 HUMAN PRESCRIPTION DRUG INDOCIN indomethacin SUPPOSITORY RECTAL 20081103 ANDA ANDA073314 Iroko Pharmaceuticals, LLC INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42211-201_84411c56-d525-411f-8558-4be3c322466f 42211-201 HUMAN PRESCRIPTION DRUG Tivorbex indomethacin CAPSULE ORAL 20140224 NDA NDA204768 Iroko Pharmaceuticals, LLC INDOMETHACIN 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42211-202_84411c56-d525-411f-8558-4be3c322466f 42211-202 HUMAN PRESCRIPTION DRUG Tivorbex indomethacin CAPSULE ORAL 20140224 NDA NDA204768 Iroko Pharmaceuticals, LLC INDOMETHACIN 40 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42211-203_0262891b-015a-41f9-ab63-052902ec8541 42211-203 HUMAN PRESCRIPTION DRUG Zorvolex diclofenac CAPSULE ORAL 20131031 NDA NDA204592 Iroko Pharmaceuticals LLC DICLOFENAC 18 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42211-204_0262891b-015a-41f9-ab63-052902ec8541 42211-204 HUMAN PRESCRIPTION DRUG Zorvolex diclofenac CAPSULE ORAL 20131031 NDA NDA204592 Iroko Pharmaceuticals LLC DICLOFENAC 35 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42212-003_8f5f2d22-bfb8-45ab-91f3-087f5680f935 42212-003 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20090701 ANDA ANDA074415 Levista, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 42213-042_d97df965-4870-436c-9b94-9d9804792a2d 42213-042 HUMAN OTC DRUG Advanced Petrolatum petrolatum OINTMENT TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part347 Ultra Seal Corporation PETROLATUM 1 g/g 42213-160_81e0f007-afbd-4167-b448-9d087d000e0d 42213-160 HUMAN OTC DRUG Ultra Tuss guaifenesin SYRUP ORAL 20120619 OTC MONOGRAPH FINAL part341 Ultra Seal Corporation GUAIFENESIN 100 mg/5mL 42213-161_837bf4fe-8cb0-43be-9b9c-8801996475c0 42213-161 HUMAN OTC DRUG Ultra Tuss DM guaifenesin dextromethorphan HBr SYRUP ORAL 20120619 OTC MONOGRAPH FINAL part341 Ultra Seal Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 42213-162_d8d9af92-9ed2-451a-93a3-b3747b281fc2 42213-162 HUMAN OTC DRUG Ultra Tuss Safe guaifenesin dextromethorphan HBr SYRUP ORAL 20120619 OTC MONOGRAPH FINAL part341 Ultra Seal Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 42213-360_0924012d-38e7-4dc5-8998-45807b8d4368 42213-360 HUMAN OTC DRUG ULTRA SEAL Triple Antibiotic neomycin, polymixin, bacitracin OINTMENT TOPICAL 20110412 OTC MONOGRAPH FINAL part333B Ultra Seal Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [iU]/g; mg/g; [iU]/g 42213-365_dc08c11b-2623-4c2c-a8e1-44d464bdd4af 42213-365 HUMAN OTC DRUG Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20120503 OTC MONOGRAPH NOT FINAL part347 Ultra Seal Corporation ZINC OXIDE 200 mg/g 42213-370_315472a4-d04d-4c1c-bb52-71521e68a08d 42213-370 HUMAN OTC DRUG Advanced Hydrocortisone hydrocortisone CREAM TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part348 Ultra Seal Corporation HYDROCORTISONE 10 mg/g 42213-375_9765bca5-dce9-46d3-b668-5bb9403003ba 42213-375 HUMAN OTC DRUG Advanced Relief A and D Petrolatum OINTMENT TOPICAL 20111201 OTC MONOGRAPH FINAL part347 Ultra Seal Corporation PETROLATUM 937.5 mg/g 42213-400_0a9060d2-613d-40b9-ba98-7dffc5a29851 42213-400 HUMAN OTC DRUG Ultra Seal Bacitracin BACITRACIN ZINC OINTMENT TOPICAL 20111204 OTC MONOGRAPH FINAL part333B Ultra Seal Corporation BACITRACIN ZINC 500 [iU]/g 42217-100_6df80051-a6eb-4d58-9670-496ec1c6bebd 42217-100 HUMAN OTC DRUG TONG LUO QU TONG GAO CAMPHOR AND MENTHOL POULTICE TRANSDERMAL 20100602 OTC MONOGRAPH NOT FINAL part348 HENAN LINGRUI PHARMACEUTICAL CO LTD CAMPHOR (NATURAL); MENTHOL 5; 3.4 g/1; g/1 42217-200_823a4603-d2cd-416c-86c4-d50c3f53a439 42217-200 HUMAN OTC DRUG TONG LUO QU TONG GAO CAMPHOR, MENTHOL PLASTER TRANSDERMAL 20100602 OTC MONOGRAPH NOT FINAL part348 Henan Lingrui Pharmaceutical Co.; Ltd CAMPHOR (NATURAL); MENTHOL 5; 3.4 g/100g; g/100g 42217-201_23666d8f-e4f9-4331-b50e-78c86bb9efd4 42217-201 HUMAN OTC DRUG Shang Shi Zhi Tong Gao Camphor, Menthol, Methyl Salicylate PLASTER TRANSDERMAL 20100602 OTC MONOGRAPH NOT FINAL part348 Henan Lingrui Pharmaceutical Co.; Ltd CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 3; 1.5; 2.5 g/100g; g/100g; g/100g 42217-203_7cfda1fe-41e0-4e20-832f-94048ad8dda9 42217-203 HUMAN OTC DRUG Zhuang Gu She Xiang Zhi Tong Gao Camphor, Menthol PLASTER TRANSDERMAL 20100602 OTC MONOGRAPH NOT FINAL part348 Henan Lingrui Pharmaceutical Co.; Ltd CAMPHOR (NATURAL); MENTHOL 3; 2.9 g/100g; g/100g 42217-204_68e028fb-2d3c-4df0-8d62-d74bf277091f 42217-204 HUMAN OTC DRUG La Jiao Feng Shi Gao Menthol PLASTER TRANSDERMAL 20100602 OTC MONOGRAPH NOT FINAL part348 Henan Lingrui Pharmaceutical Co Ltd MENTHOL 3 g/100g 42221-0001_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0001 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g 42221-0002_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0002 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g 42221-0003_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0003 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g 42221-0004_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0004 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g 42221-0005_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0005 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g 42221-0006_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0006 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g 42221-0007_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0007 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g 42221-0008_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0008 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g 42221-0009_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0009 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g 42221-0010_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0010 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g 42221-0011_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0011 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g 42221-0012_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0012 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g 42221-0013_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0013 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g 42221-0014_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0014 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g 42227-081_5688abd3-891e-4b34-b67a-3ebfc17b8656 42227-081 PLASMA DERIVATIVE Cinryze HUMAN C1-ESTERASE INHIBITOR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081201 BLA BLA125267 ViroPharma Biologics HUMAN C1-ESTERASE INHIBITOR 500 [iU]/5mL Human C1 Esterase Inhibitor [EPC],Decreased Vascular Permeability [PE],Kallikrein Inhibitors [MoA] 42233-095_889bcacc-575b-4f52-b52f-f21e5e5f8b82 42233-095 HUMAN OTC DRUG eB5 Age Sport Formula Hydroquinone LOTION TOPICAL 20061001 OTC MONOGRAPH NOT FINAL part358A eb5 Corporations HYDROQUINONE 2 g/100mL 42236-001_e411d839-b51f-4e99-b0e1-2f8ace7bd53a 42236-001 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120920 ANDA ANDA090663 hameln rds gmbh GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 42236-002_e411d839-b51f-4e99-b0e1-2f8ace7bd53a 42236-002 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120920 ANDA ANDA090663 hameln rds gmbh GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 42238-111_59aea1b5-c3c1-4e03-bc7f-92b743f5e783 42238-111 HUMAN PRESCRIPTION DRUG ACTIMMUNE Interferon gamma-1b INJECTION, SOLUTION SUBCUTANEOUS 20130909 BLA BLA103836 Vidara Therapeutics Inc INTERFERON GAMMA-1B 100 ug/.5mL Interferon gamma [EPC],Interferon-gamma [Chemical/Ingredient] 42241-001_cb0ea164-d365-4e87-9d80-2d862a95afc4 42241-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20111101 UNAPPROVED MEDICAL GAS - INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC. OXYGEN 995 mL/L 42241-002_50104d55-f475-4062-8701-eca189a4d5e8 42241-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20111101 UNAPPROVED MEDICAL GAS INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC. NITROGEN 995 mL/L 42248-101_a92c28f0-6829-455d-b4fc-2bacb6f346db 42248-101 HUMAN OTC DRUG Hydromarine Extreme OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL 42248-102_1a50face-9868-4e0a-ad0f-72d68dd8416f 42248-102 HUMAN OTC DRUG Anti Aging Star OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL 42248-103_b8142397-d9f0-4fdb-a542-46731e3b7b7d 42248-103 HUMAN OTC DRUG Vita K OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL 42248-104_b769397d-8e80-4d92-9e25-60301a2b4f54 42248-104 HUMAN OTC DRUG Calcium Repair OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL 42248-105_40e4fb62-5109-4acb-8ba5-ebc8e3c76fb0 42248-105 HUMAN OTC DRUG Retin C OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL 42248-106_0005afe5-6eb3-4eea-baee-21c117b4528b 42248-106 HUMAN OTC DRUG Expression Marine OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL 42248-107_76b70628-b13f-4273-ac4b-c773c289d8ca 42248-107 HUMAN OTC DRUG Regemarine Extreme OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL 42248-108_3d7512ce-c32f-4f7f-aea4-ecfa459d7881 42248-108 HUMAN OTC DRUG Seborrheic Purifying OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL 42248-109_f5c09f39-a618-4b42-860f-a9fe64b0f9eb 42248-109 HUMAN OTC DRUG Drymarine Age Control OCTINOXATE, TITANIUM DIOXIDE, AVOBENZONE CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL AVOBENZONE; OCTINOXATE; TITANIUM DIOXIDE 1.5; 3.75; 12.5 mL/50mL; mL/50mL; mL/50mL 42248-110_fba51ef7-8b81-4b54-9707-b2c75667b4a5 42248-110 HUMAN OTC DRUG Hydromarine Extreme OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 15 mL/200mL 42248-111_3d1bfec3-7f57-4160-9aae-a3497b0abf86 42248-111 HUMAN OTC DRUG La Creme Plus OCTINOXATE CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL 42248-112_2271626b-8be0-483f-a6a3-5b9f5176f40b 42248-112 HUMAN OTC DRUG Regemarine Extreme OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 15 mL/200mL 42248-113_f5e66a01-b75c-466e-bcde-e8fe31456ed3 42248-113 HUMAN OTC DRUG Anti Aging Star OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 15 mL/200mL 42248-114_df501bee-7bbd-4945-99c8-fb774f63ea50 42248-114 HUMAN OTC DRUG Retin C OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 15 mL/200mL 42248-115_791d0768-1857-417d-a41c-6d8f4922b8b6 42248-115 HUMAN OTC DRUG Expression Marine OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 15 mL/200mL 42248-116_bf9ac16a-ea55-4129-8da4-fd0420d08865 42248-116 HUMAN OTC DRUG Calcium Repair OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 15 mL/200mL 42248-117_dcacb642-3435-4ed8-b0c6-c26d68b7588c 42248-117 HUMAN OTC DRUG Seborrheic Purifying OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 15 mL/200mL 42248-118_f37ded20-5c9c-4562-bae2-3424e5c135ea 42248-118 HUMAN OTC DRUG Vita K OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 15 mL/200mL 42248-120_0b905f54-76b6-4b1f-8655-b4e7f11a3da1 42248-120 HUMAN OTC DRUG Sun Care For Face OCTINOXATE AVOBENZONE ZINC OXIDE OCTOCRYLENE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL AVOBENZONE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 1.8; 4.5; 4.5; 14.4 mL/60mL; mL/60mL; mL/60mL; mL/60mL 42248-121_46664fc4-6c03-4e9f-8b9a-0159dcb0bdd8 42248-121 HUMAN OTC DRUG Sun Care For Face OCTINOXATE AVOBENZONE ZINC OXIDE OCTOCRYLENE EMULSION TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL AVOBENZONE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 1.8; 4.5; 4.5; 14.4 mL/60mL; mL/60mL; mL/60mL; mL/60mL 42248-122_74295561-d8ee-4030-9409-70896625be7c 42248-122 HUMAN OTC DRUG SUN CARE FOR BODY OCTINOXATE AVOBENZONE ZINC OXIDE OCTOCRYLENE EMULSION TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL AVOBENZONE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 4.5; 11.25; 15; 36 mL/150mL; mL/150mL; mL/150mL; mL/150mL 42248-123_19baf3b8-1601-4a11-a5dc-b4141882d5f8 42248-123 HUMAN OTC DRUG Drymarine Age Control OCTINOXATE, TITANIUM DIOXIDE, AVOBENZONE CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL AVOBENZONE; OCTINOXATE; TITANIUM DIOXIDE 6; 15; 50 mL/200mL; mL/200mL; mL/200mL 42248-124_7525f0f3-d258-4f96-9566-309ffb91176b 42248-124 HUMAN OTC DRUG Protector R Plus OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 15; 12; 50 mL/200mL; mL/200mL; mL/200mL 42248-125_ed471670-2e13-4e44-8a0a-09a095c5a57c 42248-125 HUMAN OTC DRUG Hyaluronic Filler Serum OCTINOXATE CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 2.25 mL/30mL 42248-126_048f292f-30de-4686-a9a8-fe4cb240ee1d 42248-126 HUMAN OTC DRUG Silky Finish Fluid OCTINOXATE LOTION TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 1.125 mL/15mL 42248-127_c1540d77-5935-458f-b238-50e2e49b57cf 42248-127 HUMAN OTC DRUG Protector R Plus OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 3.75; 3; 12.5 mL/50mL; mL/50mL; mL/50mL 42248-128_8c1dcf29-11ed-40f8-a0e9-efcb9dbd6417 42248-128 HUMAN OTC DRUG Silky Finish Fluid OCTINOXATE LOTION TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 2.25 mL/30mL 42248-129_0ef55387-f92b-4e32-9f13-faab49ddcb2c 42248-129 HUMAN OTC DRUG Whitening Glycobest OCTINOXATE avobenzone titanium oxide CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL AVOBENZONE; OCTINOXATE; TITANIUM DIOXIDE 1.5; 3.5; 12.5 mL/50mL; mL/50mL; mL/50mL 42248-130_84f78d03-09df-4ca4-ab2e-e7bac2e6551e 42248-130 HUMAN OTC DRUG PRO LASER BODY OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 11.25; 9; 37.5 mL/150mL; mL/150mL; mL/150mL 42248-131_7368590d-b54c-43d0-a4dc-627c20467892 42248-131 HUMAN OTC DRUG PERFECT BUST BODY OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 11.25 mL/150mL 42248-132_a70fbcf1-c3e5-4653-a3c7-a3e29a190ac0 42248-132 HUMAN OTC DRUG FIRMING AND MOISTURIZING BODY OCTINOXATE EMULSION TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 18.75 mL/250mL 42248-133_b9f2c52e-0ab5-4cf7-8c36-8999ee352beb 42248-133 HUMAN OTC DRUG La Creme P OCTINOXATE AVOBENZONE TITANIUM DIOXIDE CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL AVOBENZONE; OCTINOXATE; TITANIUM DIOXIDE 1.5; 3.75; 12.5 mL/50mL; mL/50mL; mL/50mL 42254-001_644ddc43-b2fa-44bd-aeb7-2547defb85e0 42254-001 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 19991027 NDA NDA021087 Rebel Distributors Corp OSELTAMIVIR PHOSPHATE 75 mg/1 Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] 42254-002_a7c456e6-403b-4aae-a576-60b106bf66a7 42254-002 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110209 ANDA ANDA077154 Rebel Distributors Corp. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42254-003_a3dc310a-3d75-4e1e-9f9f-ed5c77ff7bfe 42254-003 HUMAN PRESCRIPTION DRUG BACITRACIN BACITRACIN OINTMENT OPHTHALMIC 20100111 ANDA ANDA061212 Rebel Distributors Corp BACITRACIN 500 [iU]/g Decreased Cell Wall Synthesis & Repair [PE] 42254-004_12d06309-0483-48c6-a9f2-b25dcc31db72 42254-004 HUMAN PRESCRIPTION DRUG Proventil HFA Albuterol Sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20011001 NDA NDA020503 Rebel Distributors Corp. ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 42254-005_34f4cc6f-3751-470a-95c1-69ea911e24f5 42254-005 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Rebel Distributors Corp. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 42254-006_72287bb4-3f70-4e12-aaf3-cfff48e044f8 42254-006 HUMAN PRESCRIPTION DRUG Betadine povidone-iodine SOLUTION OPHTHALMIC 20000401 NDA NDA018634 Rebel Distributors Corp POVIDONE-IODINE 5 mg/mL 42254-008_74238d87-5f82-4a5e-a920-a9fc68115e91 42254-008 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20100707 ANDA ANDA040350 Rebel Distributors Corp. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 42254-009_74238d87-5f82-4a5e-a920-a9fc68115e91 42254-009 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20100707 ANDA ANDA040350 Rebel Distributors Corp. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 42254-010_ff603c99-6620-4945-acdc-c9150b6f77d4 42254-010 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 19710723 ANDA ANDA080154 Rebel Distributors Corp. PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 42254-011_4743a48b-d4b5-4054-85e1-9d64cc40de25 42254-011 HUMAN PRESCRIPTION DRUG Eplerenone Eplerenone TABLET ORAL 20080801 ANDA ANDA078510 Rebel Distributors Corp. EPLERENONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 42254-012_1ceb560b-1a62-408d-8e30-23113e8c9dd3 42254-012 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100427 ANDA ANDA078938 Rebel Distributors Corp TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 42254-013_4d4131f8-79d0-40a4-87e8-667fd2db8d7a 42254-013 HUMAN PRESCRIPTION DRUG Cyclopentolate Hydrochloride Cyclopentolate Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19940429 ANDA ANDA040075 Rebel Distributors Corp CYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL 42254-014_10f918f7-4782-470e-a50e-35c7c66bfd79 42254-014 HUMAN PRESCRIPTION DRUG Nuvigil armodafinil TABLET ORAL 20090601 NDA NDA021875 Rebel Distributors Corp ARMODAFINIL 50 mg/1 CIV 42254-015_4f4fc43f-bcd5-4f98-bafc-20db6207c603 42254-015 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 19901130 ANDA ANDA073193 Rebel Distributors Corp DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42254-019_2a8de5aa-936a-493e-a0e3-813cbc969c6d 42254-019 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 19961217 NDA AUTHORIZED GENERIC NDA020702 Rebel Distributors Corp ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42254-022_1f8c4794-52cf-46d5-b0e5-3e758941d606 42254-022 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20110726 ANDA ANDA088628 Rebel Distributors Corp ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII 42254-023_043665e5-c6e0-4353-9933-6ba9e4860842 42254-023 HUMAN PRESCRIPTION DRUG FLURBIPROFEN SODIUM flurbiprofen sodium SOLUTION/ DROPS OPHTHALMIC 19970529 NDA AUTHORIZED GENERIC NDA019404 Rebel Distributors Corp FLURBIPROFEN SODIUM .3 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42254-025_d3620ebe-87e1-4a93-96cc-ff20ddbb30b2 42254-025 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Rebel Distributors Corp LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42254-028_d3620ebe-87e1-4a93-96cc-ff20ddbb30b2 42254-028 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Rebel Distributors Corp LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42254-029_c4ca2b1a-fdb8-4131-8b80-8784e79c1ce5 42254-029 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100715 ANDA ANDA072235 Rebel Distributors Corp BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 42254-030_706f3bb5-1ada-420a-9d8e-79aea018df53 42254-030 HUMAN OTC DRUG clotrimazole Clotrimazole CREAM TOPICAL 20110603 OTC MONOGRAPH FINAL part333C Rebel Distributors Corp CLOTRIMAZOLE 1 g/100g 42254-031_fea57e0a-c472-4c83-9afd-6765a16600b9 42254-031 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20110620 OTC MONOGRAPH FINAL part333B Rebel Distributors Corp BACITRACIN 500 [USP'U]/g 42254-032_330e35ed-fd6b-4123-864a-a5aa339c24d6 42254-032 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Rebel Distributors Corp SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42254-033_fce0f66c-da3b-4037-ba0a-e89b1e301c16 42254-033 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 Rebel Distributors Corp ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42254-034_940f3140-fe00-4297-ba81-f49bc3a3ace0 42254-034 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Rebel Distributors Corp IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42254-035_0defd325-d763-481e-afe8-86075e3c7e79 42254-035 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20100301 ANDA ANDA090200 Rebel Distributors Corp METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 42254-036_1b291d0a-1350-4637-bab3-f0bf43ab2a13 42254-036 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Rebel Distributors Corp DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42254-037_51f3222f-bc05-4117-881d-85880b092e42 42254-037 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 20110118 ANDA ANDA073517 Rebel Distributors Corp KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42254-038_0defd325-d763-481e-afe8-86075e3c7e79 42254-038 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20100301 ANDA ANDA090200 Rebel Distributors Corp METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 42254-039_d7131853-8850-45bd-9227-c4b1916dd28d 42254-039 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20080420 ANDA ANDA065390 Rebel Distributors Corp RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 42254-040_b28a2d3c-69ca-4c97-915b-41135b9b5bc0 42254-040 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 Rebel Distributors Corp METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 42254-041_95990ec1-9cfd-4b94-afbd-7ced6ecca567 42254-041 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20110301 ANDA ANDA075693 Rebel Distributors Corp IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 42254-043_fac73e19-3809-4846-8abc-f42a47c224ae 42254-043 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20071022 ANDA ANDA075576 Rebel Distributors Corp OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 42254-045_749af379-2de0-4644-ae06-e8b03d863582 42254-045 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Rebel Distributors Corp PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 42254-046_200e9378-f0be-4d8c-a243-9283cd4f1977 42254-046 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Rebel Distributors Corp ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 42254-048_fce0f66c-da3b-4037-ba0a-e89b1e301c16 42254-048 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 Rebel Distributors Corp ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42254-049_1bc85f95-c26a-4037-a02a-2248f6518fe2 42254-049 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Rebel Distributors Corp GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42254-050_a4e1d3bc-4e97-4ff0-9e30-22a699c96072 42254-050 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42254-051_6ddf4f5b-b6bb-4a15-a621-cd327d27ec53 42254-051 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Rebel Distributors Corp ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 42254-052_7e2f72a2-a76f-46a0-9a0b-4414633bb864 42254-052 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20100430 ANDA ANDA075009 Rebel Distributors Corp ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42254-053_fac73e19-3809-4846-8abc-f42a47c224ae 42254-053 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20071022 ANDA ANDA075576 Rebel Distributors Corp OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 42254-054_f8c7c414-fcd2-47dd-8226-8d0c35d3e9f0 42254-054 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20110209 ANDA ANDA077662 Rebel Distributors Corp GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42254-055_9cbdc7a7-2e87-4ba0-b5e5-70e15caae63d 42254-055 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100816 ANDA ANDA040702 Rebel Distributors Corp HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42254-056_eb02779c-acdc-48ed-9d23-ca39ba152d0d 42254-056 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110901 ANDA ANDA078526 Rebel Distributors Corp LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42254-057_5cc4daa2-f108-4672-9dd8-06c3785bed28 42254-057 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 Rebel Distributors Corp DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 42254-059_05a94f49-3f12-462c-9180-ae75719d3441 42254-059 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20120410 ANDA ANDA075185 Rebel Distributors Corp DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42254-060_330e35ed-fd6b-4123-864a-a5aa339c24d6 42254-060 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Rebel Distributors Corp SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42254-061_c4ca2b1a-fdb8-4131-8b80-8784e79c1ce5 42254-061 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100715 ANDA ANDA072234 Rebel Distributors Corp BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 42254-062_53b33c73-a220-4add-ba61-b00e9e9f852b 42254-062 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20100105 ANDA ANDA074118 Rebel Distributors Corp PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42254-063_940f3140-fe00-4297-ba81-f49bc3a3ace0 42254-063 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Rebel Distributors Corp IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42254-064_e5b36fbf-4db1-43b3-bf04-39022f74d0b9 42254-064 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 Rebel Distributors Corp NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 42254-065_6efbbff4-db09-4d9d-93dd-6b6ce9271514 42254-065 HUMAN OTC DRUG Lice Treatment permethrin LOTION TOPICAL 20100328 ANDA ANDA075014 Rebel Distributors Corp PERMETHRIN 1 mg/100mL 42254-066_17b2ac2b-f709-433b-961f-57a8dbe1c36a 42254-066 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 Rebel Distributors Corp CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42254-067_ceb0fc2d-9039-4961-84b6-ceb2a2649c50 42254-067 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 19950415 ANDA ANDA062512 Rebel Distributors Corp NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 42254-068_68723240-fed0-4ba7-bb7a-fac3de2398c9 42254-068 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070227 ANDA ANDA040755 Rebel Distributors Corp CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 42254-069_ae578c2d-7ea2-4e18-bad8-c1da2429b7cb 42254-069 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL TOPICAL 20060713 ANDA ANDA077547 Rebel Distributors Corp METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 42254-070_407a8f85-11c4-4404-8678-1c5e68860c8f 42254-070 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20110919 ANDA ANDA073652 Rebel Distributors Corp NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 42254-071_8ca95053-18cb-468d-8e72-e02cf4d7c3bc 42254-071 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20110102 ANDA ANDA076345 Rebel Distributors Corp GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 42254-073_15f7cde7-8dc2-4b07-83a9-9b86d6ec7f43 42254-073 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA090149 Rebel Distributors Corp AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 42254-074_15f7cde7-8dc2-4b07-83a9-9b86d6ec7f43 42254-074 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA090149 Rebel Distributors Corp AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 42254-075_426f6918-7705-4988-a875-823196f43859 42254-075 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20110308 ANDA ANDA075536 Rebel Distributors Corp DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 42254-076_70cc0291-495b-4e2f-a431-ade9759ec4b7 42254-076 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822 ANDA ANDA089859 Rebel Distributors Corp CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 42254-077_6c450150-a7a4-46f3-b62a-848eeefada06 42254-077 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Rebel Distributors Corp ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 42254-078_ce85fa92-783e-4f71-b7ae-bc0eb0410e13 42254-078 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100113 ANDA ANDA040682 Rebel Distributors Corp BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 42254-079_7bbe8e4b-5210-400c-b89c-62c1822148bd 42254-079 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040356 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42254-080_4511cefb-084b-4191-899c-f500091f589c 42254-080 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Rebel Distributors Corp CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42254-081_4f5f9977-2a78-4bf1-8e14-20dd24a119b4 42254-081 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 Rebel Distributors Corp INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42254-086_2373655d-ac74-43f5-a041-9f41a5b92206 42254-086 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030601 ANDA ANDA076312 Rebel Distributors Corp MIRTAZAPINE 15 mg/1 42254-087_2373655d-ac74-43f5-a041-9f41a5b92206 42254-087 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030601 ANDA ANDA076312 Rebel Distributors Corp MIRTAZAPINE 30 mg/1 42254-088_b61aec30-66c0-4abe-a8ad-2d98d88f21b8 42254-088 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC 19960726 ANDA ANDA040069 Rebel Distributors Corp DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42254-089_940f3140-fe00-4297-ba81-f49bc3a3ace0 42254-089 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Rebel Distributors Corp IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42254-090_58200048-a278-4f9a-b705-affc358537fb 42254-090 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Rebel Distributors Corp GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 42254-092_03a2a7f0-406c-4784-84c1-5fd5f5be4773 42254-092 HUMAN PRESCRIPTION DRUG Tamiflu Oseltamivir Phosphate POWDER, FOR SUSPENSION ORAL 20110711 NDA NDA021246 Rebel Distributors Corp OSELTAMIVIR PHOSPHATE 6 mg/mL Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] 42254-093_565fcd92-6f4a-4060-be06-3001159264d9 42254-093 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20020709 ANDA ANDA075616 Rebel Distributors Corp NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 42254-094_0c6eed96-edfd-4e65-8eff-59d1ad51a59a 42254-094 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20110118 ANDA ANDA074229 Rebel Distributors Corp NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 42254-095_4bb9f3b7-2cc0-487d-9afa-027ddf7d7c16 42254-095 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Rebel Distributors Corp NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 42254-096_706af4a6-6595-48f9-be93-d57da75702c3 42254-096 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20091009 ANDA ANDA078203 Rebel Distributors Corp LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42254-097_6c450150-a7a4-46f3-b62a-848eeefada06 42254-097 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Rebel Distributors Corp ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 42254-100_7bbe8e4b-5210-400c-b89c-62c1822148bd 42254-100 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19881202 ANDA ANDA089971 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42254-102_de240524-7865-46a2-aa11-d06356ba9339 42254-102 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20091201 ANDA ANDA078345 Rebel Distributors Corp PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42254-103_3345e995-7c5a-4e1c-949a-396ca7332023 42254-103 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Rebel Distributors Corp GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42254-104_7617f4a4-8812-44c4-8386-bc991f4d3a77 42254-104 HUMAN PRESCRIPTION DRUG ARMOUR THYROID THYROID TABLET ORAL 20101019 UNAPPROVED DRUG OTHER Rebel Distributors Corp THYROID 15 mg/1 42254-105_7617f4a4-8812-44c4-8386-bc991f4d3a77 42254-105 HUMAN PRESCRIPTION DRUG ARMOUR THYROID THYROID TABLET ORAL 20101019 UNAPPROVED DRUG OTHER Rebel Distributors Corp THYROID 30 mg/1 42254-106_d3620ebe-87e1-4a93-96cc-ff20ddbb30b2 42254-106 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Rebel Distributors Corp LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42254-107_87b3326b-7751-4aa5-b9c1-7e72a9daae1f 42254-107 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Rebel Distributors Corp ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 42254-108_3993eb55-f0e8-496c-a496-19dc509699e8 42254-108 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Rebel Distributors Corp CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42254-109_f8c7c414-fcd2-47dd-8226-8d0c35d3e9f0 42254-109 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20110209 ANDA ANDA077662 Rebel Distributors Corp GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42254-110_03c66d8c-186a-4923-9a32-07ab07d472ad 42254-110 HUMAN PRESCRIPTION DRUG METHOTREXATE METHOTREXATE TABLET ORAL 19531207 NDA NDA008085 Rebel Distributors Corp METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 42254-111_706af4a6-6595-48f9-be93-d57da75702c3 42254-111 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20091009 ANDA ANDA078203 Rebel Distributors Corp LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42254-112_3345e995-7c5a-4e1c-949a-396ca7332023 42254-112 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Rebel Distributors Corp GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42254-113_706af4a6-6595-48f9-be93-d57da75702c3 42254-113 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20091009 ANDA ANDA078203 Rebel Distributors Corp LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42254-114_5b50291b-68c7-45a6-ae38-59f137ca7620 42254-114 HUMAN PRESCRIPTION DRUG Xodol hydrocodone bitartrate and acetaminophen TABLET ORAL 20111010 ANDA ANDA040556 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42254-115_a4e1d3bc-4e97-4ff0-9e30-22a699c96072 42254-115 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42254-116_3993eb55-f0e8-496c-a496-19dc509699e8 42254-116 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Rebel Distributors Corp CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42254-117_cf785971-902f-4423-866e-6edf44706679 42254-117 HUMAN OTC DRUG good sense ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990107 ANDA ANDA074937 Rebel Distributors Corp IBUPROFEN 100 mg/5mL 42254-118_b03ca090-40fe-44b0-838a-69aed3424a06 42254-118 HUMAN PRESCRIPTION DRUG Silver Sulfadiazene Silver Sulfadiazine CREAM TOPICAL 19820225 NDA NDA018578 Rebel Distributors Corp SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42254-119_3993eb55-f0e8-496c-a496-19dc509699e8 42254-119 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Rebel Distributors Corp CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42254-121_9c244c88-dcc4-44fb-b0d9-13732dc705f5 42254-121 HUMAN PRESCRIPTION DRUG Etodolac etodolac CAPSULE ORAL 20100331 ANDA ANDA075078 Rebel Distributors Corp ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42254-122_637bf5a5-bc69-434d-a199-c2b89837002a 42254-122 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20050121 ANDA ANDA076673 Rebel Distributors Corp CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 42254-123_4a2530bc-176d-41c9-ab38-212165cbfa82 42254-123 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20110808 ANDA ANDA076447 Rebel Distributors Corp FEXOFENADINE HYDROCHLORIDE 60 mg/1 42254-124_18f7b809-b270-4d44-8065-685bac30efc0 42254-124 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20070910 ANDA ANDA077058 Rebel Distributors Corp PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 42254-125_4a58eea7-1956-4660-9899-600fd477f422 42254-125 HUMAN OTC DRUG Non-Habit Forming Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120329 OTC MONOGRAPH NOT FINAL part334 Rebel Distributors Corp DOCUSATE SODIUM 100 mg/1 42254-126_b971e151-4a68-4c01-8f9b-8c56f6bad18a 42254-126 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20101223 ANDA ANDA075022 Rebel Distributors Corp BUSPIRONE HYDROCHLORIDE 15 mg/1 42254-127_a4587ea9-c06b-4603-beea-1ef926a4d0be 42254-127 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070501 ANDA ANDA065259 Rebel Distributors Corp CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42254-129_330e35ed-fd6b-4123-864a-a5aa339c24d6 42254-129 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Rebel Distributors Corp SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42254-130_5fc5f29a-51e3-4f28-8b22-2ba9a7e64e7c 42254-130 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Rebel Distributors Corp ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 42254-131_44a07041-456a-4b0b-9a8a-9e1715327d33 42254-131 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 Rebel Distributors Corp PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42254-132_f20e4b9d-2f50-412f-9710-223af851078b 42254-132 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100820 ANDA ANDA040807 Rebel Distributors Corp HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42254-133_ec3d8135-2892-4186-ac31-c7deadd0b975 42254-133 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 20091022 ANDA ANDA075382 Rebel Distributors Corp ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 42254-134_aac6c6a4-17a3-4643-bc89-db7259aca03a 42254-134 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Rebel Distributors Corp PREGABALIN 225 mg/1 CV 42254-136_20b3934b-edc4-40b8-b5fa-17259a200c5d 42254-136 HUMAN OTC DRUG hydrocortisone Hydrocortisone CREAM TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part348 Rebel Distributors Corp HYDROCORTISONE 1 g/100g 42254-137_323bcad0-1e11-4946-a151-1a33557f0bfb 42254-137 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20110111 ANDA ANDA065085 Rebel Distributors Corp MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 42254-138_296e5977-0e8c-4147-a94d-374eb913ab51 42254-138 HUMAN OTC DRUG Cetirizine hydrochloride Cetirizine hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Rebel Distributors Corp CETIRIZINE HYDROCHLORIDE 10 mg/1 42254-139_7aef59fd-9baf-48eb-a16b-1b2ceafd3d84 42254-139 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 Rebel Distributors Corp AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 42254-140_a4fd8978-2036-43cb-ab16-b0dd98d6cd5b 42254-140 HUMAN PRESCRIPTION DRUG Prometh with Codeine Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 19841031 ANDA ANDA088763 Rebel Distributors Corp CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CV 42254-141_a0f84fac-3f7c-45c0-a2e8-ce39fb2bd630 42254-141 HUMAN OTC DRUG Enteric Coated Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20110920 OTC MONOGRAPH FINAL part343 Rebel Distributors Corp ASPIRIN 325 mg/1 42254-142_250ac5c3-7cb0-4b93-a799-5aaa708144cd 42254-142 HUMAN PRESCRIPTION DRUG Desonide Desonide CREAM TOPICAL 20060411 NDA NDA017010 Rebel Distributors Corp DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42254-143_53b33c73-a220-4add-ba61-b00e9e9f852b 42254-143 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20100105 ANDA ANDA074116 Rebel Distributors Corp PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42254-144_a4e1d3bc-4e97-4ff0-9e30-22a699c96072 42254-144 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42254-145_89f9ffd5-358d-46db-9bff-66431597af64 42254-145 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20110726 ANDA ANDA088629 Rebel Distributors Corp ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 42254-146_42f92a36-4c11-44f6-8f82-716a8b7a3f08 42254-146 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20080401 ANDA ANDA065392 Rebel Distributors Corp CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42254-147_b9c6ed9c-c081-4a05-8f5e-bf646cfd5396 42254-147 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Rebel Distributors Corp ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 42254-149_0da14760-1131-4936-9a42-c40fc4db5cd0 42254-149 HUMAN PRESCRIPTION DRUG ZOVIRAX acyclovir CREAM TOPICAL 20041029 NDA NDA021478 Rebel Distributors Corp ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 42254-150_0100f9fd-5d4a-4ee6-9c7f-0b60e69e78b8 42254-150 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET ORAL 20110818 ANDA ANDA091211 Rebel Distributors Corp ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 42254-151_342ed5ed-2a53-4fc0-84f5-52b4094e1319 42254-151 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20060105 ANDA ANDA017522 Rebel Distributors Corp TRETINOIN .05 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 42254-152_1781fc07-5a2a-4b31-aad9-d0457eb704f4 42254-152 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070412 ANDA ANDA065391 Rebel Distributors Corp CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42254-153_b6b530b3-5218-4838-adee-08e477757b98 42254-153 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 20100607 ANDA ANDA074220 Rebel Distributors Corp CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42254-154_c6c69fa4-d7be-4c09-b7fa-53c40fad78a7 42254-154 HUMAN PRESCRIPTION DRUG Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate OINTMENT OPHTHALMIC 20080425 ANDA ANDA064046 Rebel Distributors Corp BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 1/g; 1/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 42254-155_5c0dbae2-328b-42b6-a8b6-55009f3c78e5 42254-155 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20120216 OTC MONOGRAPH NOT FINAL part343 Rebel Distributors Corp ACETAMINOPHEN 80 mg/1 42254-158_1e9675c8-bcff-4621-90f7-b80489e1b840 42254-158 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Rebel Distributors Corp NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42254-159_d1f543fe-ebfb-4ace-a223-d928d6b648c1 42254-159 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Rebel Distributors Corp OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42254-160_ec44482e-6194-4829-a3f7-ebe8d48a41a5 42254-160 HUMAN PRESCRIPTION DRUG EMEND aprepitant CAPSULE ORAL 20030326 NDA NDA021549 Rebel Distributors Corp APREPITANT 40 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA] 42254-161_d4f43676-0746-4765-9689-3f1e3075fa6a 42254-161 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100628 ANDA ANDA090568 Rebel Distributors Corp ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 42254-162_e843534e-47a2-46e3-92bb-d079467be606 42254-162 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 Rebel Distributors Corp CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 42254-164_395df967-7532-4de5-a8b3-b34a4b3ace84 42254-164 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20060331 ANDA ANDA085025 Rebel Distributors Corp HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42254-165_21cfe6a3-03b9-42f5-8f7f-111c56fe3c59 42254-165 HUMAN PRESCRIPTION DRUG Renova Tretinoin CREAM TOPICAL 20111018 NDA NDA021108 Rebel Distributors Corp TRETINOIN .2 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 42254-166_2a7d8bc7-45a3-497a-aa88-d3a3490aef11 42254-166 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110422 ANDA ANDA076447 Rebel Distributors Corp FEXOFENADINE HYDROCHLORIDE 180 mg/1 42254-168_330e35ed-fd6b-4123-864a-a5aa339c24d6 42254-168 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Rebel Distributors Corp SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42254-169_6f63fe2d-fe55-473f-99cd-9c8eb97e562b 42254-169 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Rebel Distributors Corp ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 42254-170_6f63fe2d-fe55-473f-99cd-9c8eb97e562b 42254-170 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Rebel Distributors Corp ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 42254-171_6f63fe2d-fe55-473f-99cd-9c8eb97e562b 42254-171 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Rebel Distributors Corp ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 42254-172_6f63fe2d-fe55-473f-99cd-9c8eb97e562b 42254-172 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Rebel Distributors Corp ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 42254-174_b6b530b3-5218-4838-adee-08e477757b98 42254-174 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate OINTMENT TOPICAL 20100607 ANDA ANDA074221 Rebel Distributors Corp CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42254-175_79957ee5-5d59-45a9-8ff8-10cc75848d2a 42254-175 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20061018 ANDA ANDA077401 Rebel Distributors Corp MOMETASONE FUROATE 1 mg/g 42254-176_3058bc96-c71d-41ed-97f2-ed68ad69a570 42254-176 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide OINTMENT TOPICAL 20091007 ANDA ANDA085691 Rebel Distributors Corp TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42254-177_f910ec1a-3896-45b9-b8b2-df50a50064a1 42254-177 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20110114 ANDA ANDA065368 Rebel Distributors Corp CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42254-178_3778db9b-ed94-4240-b045-d0d60f0ef9e9 42254-178 HUMAN OTC DRUG good neighbor pharmacy allergy diphenhydramine hydrochloride CAPSULE ORAL 19891015 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 42254-183_c22b0765-1777-4001-836a-2684daf2a35b 42254-183 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20070103 ANDA ANDA040353 Rebel Distributors Corp SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 42254-184_eefc47ff-ed87-4f98-9fa2-9cb1a0793ba9 42254-184 HUMAN OTC DRUG Diphenhist Diphenhydramine Hydrochloride LIQUID ORAL 20090926 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 42254-185_d7c0dfda-2e49-4a9e-8fbb-cc40217ccc28 42254-185 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 Rebel Distributors Corp BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 42254-187_26029ae3-d103-4ffd-b536-7366276f02bf 42254-187 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 19931129 ANDA ANDA064052 Rebel Distributors Corp TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 42254-188_144e4973-d24a-4003-b5b1-d59fd835d884 42254-188 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20060531 ANDA ANDA065266 Rebel Distributors Corp CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 42254-189_f493f828-9fdd-4723-9fc7-f691d3879696 42254-189 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Rebel Distributors Corp ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 42254-190_8dc7ea67-af85-4187-bf5a-b30878cc3f19 42254-190 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19721127 ANDA ANDA080817 Rebel Distributors Corp DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 42254-191_52802c0d-a617-4ba9-8f98-5a652025306c 42254-191 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070412 ANDA ANDA065391 Rebel Distributors Corp CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42254-194_98a219ab-aa30-46cb-ac13-5c9095a75b40 42254-194 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110127 ANDA ANDA075661 Rebel Distributors Corp IBUPROFEN 200 mg/1 42254-195_8debb03e-a237-4e0d-be06-8ae17eaa14fa 42254-195 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine Lidocaine and Prilocaine CREAM TOPICAL 20030925 ANDA ANDA076290 Rebel Distributors Corp LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 42254-196_9af821c9-8182-469a-9ba9-430903d50bfb 42254-196 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA072750 Rebel Distributors Corp METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 42254-197_87f388c6-c942-47f5-b685-0f7ce0e431f4 42254-197 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Rebel Distributors Corp CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42254-198_ec3d8135-2892-4186-ac31-c7deadd0b975 42254-198 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 20091022 ANDA ANDA075382 Rebel Distributors Corp ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 42254-202_3ff75342-03b6-462f-b6db-80bc1a52fe6c 42254-202 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 Rebel Distributors Corp PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42254-203_d6a92eba-0841-474b-96f3-778f060ab133 42254-203 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Rebel Distributors Corp OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 42254-204_d6a92eba-0841-474b-96f3-778f060ab133 42254-204 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Rebel Distributors Corp OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 42254-205_d6a92eba-0841-474b-96f3-778f060ab133 42254-205 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Rebel Distributors Corp OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 42254-206_d976599a-0ee0-4fa4-afe6-bdfbca570afe 42254-206 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076133 Rebel Distributors Corp OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 42254-212_c286dba1-e6b1-4cf0-936d-9af42d8eedc3 42254-212 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Rebel Distributors Corp ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 42254-213_a9fdc04a-b4e5-4eed-be1f-8a629dc447be 42254-213 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Rebel Distributors Corp ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 42254-214_5f215257-7c82-478f-a263-6fb37b438d69 42254-214 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42254-216_b5e516a0-d0f4-4613-ab56-b1bb440fcb78 42254-216 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 Rebel Distributors Corp ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42254-218_ac3aa150-2083-4fb0-9663-e92c1dc3135a 42254-218 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20110118 ANDA ANDA074229 Rebel Distributors Corp NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 42254-220_b56f236d-fbf8-48e3-ad42-8abe4aafcbfc 42254-220 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET, COATED ORAL 20090810 ANDA ANDA076933 Rebel Distributors Corp SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 42254-221_87a90438-84b6-4485-b43a-d9b9a58b933a 42254-221 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Rebel Distributors Corp NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42254-222_268c5d9e-a9ce-4ab5-8d7c-902c8be38c59 42254-222 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Rebel Distributors Corp OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 42254-223_16796dd0-8d42-4e0e-8a9f-2b3b8834ed84 42254-223 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040084 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42254-227_a9465919-2a5f-40f9-a8e4-ce75f7a651d4 42254-227 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091111 ANDA ANDA077255 Rebel Distributors Corp LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 42254-228_16796dd0-8d42-4e0e-8a9f-2b3b8834ed84 42254-228 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040201 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42254-229_ed49fb2a-05f6-4df5-9c75-30df41a5aae1 42254-229 HUMAN PRESCRIPTION DRUG mupirocin Mupirocin OINTMENT TOPICAL 20091030 ANDA ANDA065123 Rebel Distributors Corp MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 42254-230_c863fdd7-5919-4ee0-b2d1-952c5faf3a09 42254-230 HUMAN OTC DRUG all day pain relief Naproxen Sodium TABLET ORAL 19970114 ANDA ANDA074661 Rebel Distributors Corp NAPROXEN SODIUM 220 mg/1 42254-235_7e82dcaa-fc75-4ea2-9465-5327e2747720 42254-235 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Rebel Distributors Corp FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42254-237_4b8dbfb7-5f20-4398-937a-72ed536c57c4 42254-237 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20100730 ANDA ANDA018851 Rebel Distributors Corp INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42254-239_92f5c528-e1af-4268-9f5f-ae5558a5104c 42254-239 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20110829 ANDA ANDA078722 Rebel Distributors Corp CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 42254-242_eaf4191c-5b2f-47bd-b315-f695f8773260 42254-242 HUMAN PRESCRIPTION DRUG Junel Fe 1.5/30 norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20110121 ANDA ANDA076064 Rebel Distributors Corp 42254-243_0193faa4-9b02-4ccd-9751-de6124cc8c68 42254-243 HUMAN PRESCRIPTION DRUG Letrozole Letrozole TABLET, FILM COATED ORAL 20110603 ANDA ANDA090289 Rebel Distributors Corp LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 42254-244_16796dd0-8d42-4e0e-8a9f-2b3b8834ed84 42254-244 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040084 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42254-248_2b810942-e143-4e4f-8820-00af4f2e0c1e 42254-248 HUMAN PRESCRIPTION DRUG Flector Diclofenac Epolamine PATCH TOPICAL 20080114 NDA NDA021234 Rebel Distributors Corp DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42254-250_4ff074d6-3aa3-47cd-9667-cace82ba5185 42254-250 HUMAN PRESCRIPTION DRUG Halobetasol Propionate Halobetasol Propionate CREAM TOPICAL 20070716 ANDA ANDA078162 Rebel Distributors Corp HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42254-254_b4a84767-975f-46ae-a734-efa3ee3394fb 42254-254 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 Rebel Distributors Corp LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42254-257_a522f324-70a0-4051-830b-57a658c1e065 42254-257 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC) 20080317 ANDA ANDA076128 Rebel Distributors Corp OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 42254-260_684602ed-06c6-4633-b587-135c616f091e 42254-260 HUMAN PRESCRIPTION DRUG Levora Levonorgestrel and Ethinyl Estradiol KIT 20020410 ANDA ANDA073594 Rebel Distributors Corp 42254-261_f394be03-fefc-4679-b001-4168a204a136 42254-261 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 19961217 NDA AUTHORIZED GENERIC NDA020702 Rebel Distributors Corp ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42254-263_a4f92eb4-0df1-4300-aebd-6082fe804ac8 42254-263 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA201522 Rebel Distributors Corp MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 42254-266_6e5b23dd-0173-48a9-875d-def97662b060 42254-266 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA071250 Rebel Distributors Corp METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 42254-267_df64ffb8-f40f-479f-8c7b-a4b2011664e8 42254-267 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 19961217 NDA AUTHORIZED GENERIC NDA020702 Rebel Distributors Corp ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42254-268_1cc18146-d9be-4975-89ba-e99a85f71c76 42254-268 HUMAN PRESCRIPTION DRUG Donnatal Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide TABLET ORAL 20080507 UNAPPROVED DRUG OTHER Rebel Distributors Corp ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 42254-269_2e99000d-aec8-497a-ab2c-cd58937086c1 42254-269 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076312 Rebel Distributors Corp MIRTAZAPINE 45 mg/1 42254-277_4aad770b-a342-45c5-8199-21a124060314 42254-277 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110901 ANDA ANDA090484 Rebel Distributors Corp LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42254-281_aadcb1a8-2605-40b3-a652-2787ec833278 42254-281 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19990512 ANDA ANDA074686 Rebel Distributors Corp GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 42254-282_f0c660da-4198-4d04-87e9-5d6a7b6f75cf 42254-282 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050575 Rebel Distributors Corp AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 42254-284_da4cd3fc-906d-4468-b7f9-c20f085c95ed 42254-284 HUMAN PRESCRIPTION DRUG Nystatin nystatin OINTMENT TOPICAL 19820923 ANDA ANDA062124 Rebel Distributors Corp NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 42254-287_7a62dd77-bc33-4f4e-9cbf-980e3ec80ff7 42254-287 HUMAN PRESCRIPTION DRUG Necon 0.5/35 Norethindrone and Ethinyl Estradiol Tablets KIT 19870129 ANDA ANDA070686 Rebel Distributors Corp 42254-288_4b8c6afe-2d76-46c7-a23e-99db5e180ff6 42254-288 HUMAN PRESCRIPTION DRUG LASTACAFT alcaftadine SOLUTION/ DROPS OPHTHALMIC 20101101 NDA NDA022134 Rebel Distributors Corp ALCAFTADINE 2.5 mg/mL 42254-291_7e233783-c467-4ca7-8849-7e1526bb2de0 42254-291 HUMAN PRESCRIPTION DRUG Xodol hydrocodone bitartrate and acetaminophen TABLET ORAL 20111010 ANDA ANDA040658 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42254-295_0e4c7ff6-7bea-4257-bd95-d4d5298ae426 42254-295 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate SUPPOSITORY VAGINAL 19970430 ANDA ANDA074414 Rebel Distributors Corp MICONAZOLE NITRATE 100 ug/1 42254-300_a05c255c-6e0b-4e86-b907-738b777fc524 42254-300 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen HYDROCODONE BITARTRATE, ACETAMINOPHEN TABLET ORAL 20120517 ANDA ANDA040846 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42254-301_7e233783-c467-4ca7-8849-7e1526bb2de0 42254-301 HUMAN PRESCRIPTION DRUG Xodol hydrocodone bitartrate and acetaminophen TABLET ORAL 20111010 ANDA ANDA040556 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42254-302_23764466-adbe-4c9c-be60-3b09458d634e 42254-302 HUMAN PRESCRIPTION DRUG NEO-POLYCIN NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT OPHTHALMIC 20110715 ANDA ANDA060764 Rebel Distributors Corp BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 10000 U/g; mg/g; U/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] 42254-303_1211504c-f89b-42ed-9d7a-2e1a658a9ccf 42254-303 HUMAN PRESCRIPTION DRUG Nystatin Nystatin POWDER TOPICAL 20090915 ANDA ANDA065203 Rebel Distributors Corp NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 42254-305_09b48fda-460a-496b-8644-db205465d06c 42254-305 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110528 ANDA ANDA091267 Rebel Distributors Corp DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 42254-306_f1153794-33ae-4e9d-8c80-d29e01f82d77 42254-306 HUMAN PRESCRIPTION DRUG Griseofulviin (microsize) Griseofulvin (microsize) SUSPENSION ORAL 20070726 ANDA ANDA065394 Rebel Distributors Corp GRISEOFULVIN 125 mg/5mL Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 42254-307_2b5f69aa-2dd9-4eb8-b8b8-def1a1ec1433 42254-307 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Rebel Distributors Corp ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42254-310_41a781b4-da67-4650-a99b-593fc34465da 42254-310 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Rebel Distributors Corp LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42254-315_c9d22362-e442-4690-9aa9-9d34aef09504 42254-315 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 20040101 ANDA ANDA075010 Rebel Distributors Corp IBUPROFEN 200 mg/1 42254-319_74a80da6-0279-4946-b7ee-d3e43330ba2c 42254-319 HUMAN OTC DRUG Miconazole Nitrate miconazole nitrate CREAM TOPICAL 20030901 OTC MONOGRAPH FINAL part333C Rebel Distributors Corp MICONAZOLE NITRATE 20 mg/g 42254-322_8ce02e76-303c-4e06-a47e-0a7bbf46c3f2 42254-322 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20120127 ANDA ANDA064042 Rebel Distributors Corp NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 42254-323_4b874a3d-db5a-40dc-a69c-d67c76b82b49 42254-323 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030825 ANDA ANDA040513 Rebel Distributors Corp ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 42254-331_152fb727-d516-441e-a72b-33ddf1a325c1 42254-331 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20101015 ANDA ANDA091269 Rebel Distributors Corp LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 42254-335_851ff660-e6a4-48f8-a6d0-4c10dbb01836 42254-335 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Rebel Distributors Corp CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 42254-338_a00e07e9-2c16-4d3e-bb63-6fd2b05fe1b7 42254-338 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20071207 ANDA ANDA065326 Rebel Distributors Corp CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42254-340_a46da71a-5fe1-4021-b866-4a806a12efa8 42254-340 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42254-346_4b8f1462-d3f0-40f1-9f4a-7e54171fb8b8 42254-346 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20070223 ANDA ANDA040813 Rebel Distributors Corp ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42254-351_fa1c61c2-7e24-40ff-916e-456b8725a5cd 42254-351 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 20090223 ANDA ANDA070098 Rebel Distributors Corp METHYLDOPA 250 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 42254-353_851ff660-e6a4-48f8-a6d0-4c10dbb01836 42254-353 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Rebel Distributors Corp CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 42254-355_09ab5bc2-645f-415d-ad76-246385690176 42254-355 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SPRAY, METERED NASAL 20030331 ANDA ANDA076103 Rebel Distributors Corp IPRATROPIUM BROMIDE 42 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 42254-359_83ae6177-afbb-477f-a5ff-64d48960ffef 42254-359 HUMAN OTC DRUG nasal decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19990812 ANDA ANDA075153 Rebel Distributors Corp PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 42254-362_87d891bc-9286-4b87-a166-fccdf37fd520 42254-362 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Rebel Distributors Corp ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42254-426_87fce959-ba71-46b8-911d-2004658196ce 42254-426 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19841107 ANDA ANDA062396 Rebel Distributors Corp DOXYCYCLINE HYCLATE 50 mg/1 42255-586_0b39a81d-35dd-4e39-901f-9b9fdddc144d 42255-586 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20121227 OTC MONOGRAPH FINAL part333A ZHEJIANG GREENFACE HOUSEWARES CO., LTD. BENZALKONIUM CHLORIDE .115 g/100g 42255-587_c2466bb5-b298-4f0e-8e90-e2042d6f770f 42255-587 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20130117 OTC MONOGRAPH FINAL part333A ZHEJIANG GREENFACE HOUSEWARES CO., LTD. BENZALKONIUM CHLORIDE .1 g/100g 42255-800_62e1fc71-d6db-4b92-94a2-35bfb97784eb 42255-800 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20130314 OTC MONOGRAPH FINAL part333A ZHEJIANG GREENFACE HOUSEWARES CO., LTD. BENZALKONIUM CHLORIDE .1 g/100g 42255-900_6ca0a9f2-2668-4a35-8cf8-7e12f13733cf 42255-900 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20130314 OTC MONOGRAPH FINAL part333A ZHEJIANG GREENFACE HOUSEWARES CO., LTD. BENZALKONIUM CHLORIDE .115 g/100g 42263-101_ff916fda-5163-48a5-92df-f4a049cc94a1 42263-101 HUMAN OTC DRUG BABY SUNSCREEN SPF 30 ZINC OXIDE LOTION TOPICAL 20111230 OTC MONOGRAPH FINAL part352 SEVENTH GENERATION INC ZINC OXIDE 20 g/100g 42265-101_264fab26-2c13-422e-9395-23029b2d0b82 42265-101 HUMAN OTC DRUG Unblem Est Benzoyl Peroxide CREAM TOPICAL 20121025 OTC MONOGRAPH FINAL part333D Elli Est BENZOYL PEROXIDE 100 mg/g 42268-1001_95cfd87f-b59a-46fb-ad6b-4fad3a80a2ff 42268-1001 HUMAN OTC DRUG TS (Talmostop) niacinamide SHAMPOO TOPICAL 20120201 UNAPPROVED DRUG OTHER Talmocom Co., Ltd NIACINAMIDE .3 mL/100mL 42268-2001_c1519f8c-d48b-4bbe-9df6-827f6cdd12ac 42268-2001 HUMAN OTC DRUG TS (Talmostop) Hair Tonic niacinamide LIQUID TOPICAL 20120201 UNAPPROVED DRUG OTHER Talmocom Co., Ltd NIACINAMIDE .3 mL/100mL 42268-3001_4bb403f0-6862-467b-b611-fe881a1c5142 42268-3001 HUMAN OTC DRUG TS (Talmostop) Talhwan niacinamide PELLET TOPICAL 20120201 UNAPPROVED DRUG OTHER Talmocom Co., Ltd NIACINAMIDE .3 g/100g 42268-4001_f28fb06b-5023-4776-912a-c26f989f93ca 42268-4001 HUMAN OTC DRUG PREMIUM TS Talmostop NIACINAMIDE SHAMPOO TOPICAL 20141104 UNAPPROVED DRUG OTHER Talmocom Co., Ltd NIACINAMIDE; PANTHENOL .3; .5 g/100mL; g/100mL 42268-5001_16a573a0-41d4-40b5-b600-6526021475ca 42268-5001 HUMAN OTC DRUG PREMIUM TS Talmostop Rich NIACINAMIDE SHAMPOO TOPICAL 20141104 UNAPPROVED DRUG OTHER Talmocom Co., Ltd NIACINAMIDE; PANTHENOL .3; .5 g/100mL; g/100mL 42281-001_22afdb6f-8688-4eb6-b720-e7c8dc4ad56a 42281-001 HUMAN OTC DRUG Belli Acne Control Spot Treatment SULFUR CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part333D ABT Belli-Materna Inc SULFUR 30 mg/mL 42281-003_6a47bdbd-d9e9-4905-8f5d-10e41e6e32d8 42281-003 HUMAN OTC DRUG Belli Pure Radiance Facial Sunscreen Tinted Protection SPF 25 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 ABT Belli-Materna Inc TITANIUM DIOXIDE; ZINC OXIDE 70; 50 mg/mL; mg/mL 42283-001_0cb2ca8b-8d3c-4845-a359-84dc243868c1 42283-001 HUMAN OTC DRUG Lactovit Mens Roll-On Antiperspirant Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20111227 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM CHLOROHYDRATE 15 mL/100mL 42283-002_4a1137ea-ee43-4c18-836b-8ae00df2a002 42283-002 HUMAN OTC DRUG Lactovit Original Roll-On Antiperspirant Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20111227 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM CHLOROHYDRATE 15 mL/100mL 42283-003_96a76f3a-4328-403c-b587-94c18253d9ba 42283-003 HUMAN OTC DRUG Lactovit Sensitive Skin Roll-On Antiperspirant Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20111227 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM CHLOROHYDRATE 10 mL/100mL 42283-004_6eb416d7-5163-424b-a95e-f496e2ad10b1 42283-004 HUMAN OTC DRUG AVENA kinesia ROLL-ON DEODORANT/ANTIPERSPIRANT ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20131205 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM CHLOROHYDRATE 100 mg/mL 42283-005_a3a36894-e1b3-4ccd-8a39-0202eadd4517 42283-005 HUMAN OTC DRUG AVENA kinesia ROLL-ON DEODORANT/ANTIPERSPIRANT with Oat and Aloe Vera ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20131205 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM CHLOROHYDRATE 100 mg/mL 42283-006_a9344482-dab0-459f-bd8e-45d3a062654b 42283-006 HUMAN OTC DRUG Lactovit Lactourea ROLL-ON DEODORANT ANTIPERSPIRANT ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20140220 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM CHLOROHYDRATE 100 mg/mL 42288-000_d6ce07ce-edee-46ee-93d1-bb4411373b7f 42288-000 HUMAN OTC DRUG Spearmint and Peppermint PLAQUE A WAY Fluoride AnticavityGentle Formula Gentle Formula SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20121003 OTC MONOGRAPH FINAL part355 SLH Optimal Health LLC SODIUM FLUORIDE .24 g/100g 42291-101_cfe9abc2-5cdf-567e-4473-a91556006141 42291-101 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20091214 ANDA ANDA075047 AvKARE, Inc. ACEBUTOLOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 42291-102_cfe9abc2-5cdf-567e-4473-a91556006141 42291-102 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20091214 ANDA ANDA075047 AvKARE, Inc. ACEBUTOLOL HYDROCHLORIDE 400 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 42291-103_7d00f989-ac95-973d-fda3-0d77df23c0de 42291-103 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE Acetazolamide TABLET ORAL 20120702 ANDA ANDA084840 AvKARE, Inc. ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 42291-107_e1553f16-63e3-fccf-c7fe-9f8f621b1d42 42291-107 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20130708 ANDA ANDA075090 AvKARE, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 42291-108_90dd081f-d137-3d7b-8190-44ce0fa0c3fd 42291-108 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19990305 ANDA ANDA075382 AvKARE, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 42291-109_90dd081f-d137-3d7b-8190-44ce0fa0c3fd 42291-109 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19990305 ANDA ANDA075382 AvKARE, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 42291-110_67762ce4-8814-080f-345d-bc0d3aca1d8f 42291-110 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride ER Alfuzosin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120313 ANDA ANDA079013 AvKARE, Inc. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 42291-111_6b8429b3-e43f-6c9c-463a-b0ab723ffe1a 42291-111 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20130521 ANDA ANDA078387 AvKARE, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42291-112_6b8429b3-e43f-6c9c-463a-b0ab723ffe1a 42291-112 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20130521 ANDA ANDA078387 AvKARE, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42291-113_6b8429b3-e43f-6c9c-463a-b0ab723ffe1a 42291-113 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20130521 ANDA ANDA078387 AvKARE, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42291-120_6f5fe7a9-f6cf-136b-e197-332d47a18af6 42291-120 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20110809 ANDA ANDA062058 AvKARE, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 42291-121_6f5fe7a9-f6cf-136b-e197-332d47a18af6 42291-121 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20110809 ANDA ANDA062058 AvKARE, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 42291-122_963b7530-fa52-294a-ed5a-c3af4e749ab8 42291-122 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride Amiloride Hydrochloride TABLET ORAL 20120328 ANDA ANDA079133 AvKARE, Inc. AMILORIDE HYDROCHLORIDE 5 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 42291-125_5f26d452-9598-fd44-b33a-071c25876913 42291-125 HUMAN PRESCRIPTION DRUG Amantadine HCl AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20130807 ANDA ANDA078720 AvKARE, Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 42291-130_80544ec3-50c2-6b46-09bc-a6bacb8630d4 42291-130 HUMAN PRESCRIPTION DRUG acarbose acarbose TABLET ORAL 20131224 ANDA ANDA091343 AvKARE, Inc. ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 42291-131_80544ec3-50c2-6b46-09bc-a6bacb8630d4 42291-131 HUMAN PRESCRIPTION DRUG acarbose acarbose TABLET ORAL 20131224 ANDA ANDA091343 AvKARE, Inc. ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 42291-132_80544ec3-50c2-6b46-09bc-a6bacb8630d4 42291-132 HUMAN PRESCRIPTION DRUG acarbose acarbose TABLET ORAL 20131224 ANDA ANDA091343 AvKARE, Inc. ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 42291-140_028c547f-f666-2de8-d117-9aaf42a5c9a8 42291-140 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20130617 ANDA ANDA074056 AvKARE, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 42291-141_028c547f-f666-2de8-d117-9aaf42a5c9a8 42291-141 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20130617 ANDA ANDA074056 AvKARE, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 42291-142_028c547f-f666-2de8-d117-9aaf42a5c9a8 42291-142 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20130617 ANDA ANDA074056 AvKARE, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 42291-143_090a2b62-2d72-7d03-069b-12bb45477099 42291-143 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130708 ANDA ANDA091624 AvKARE, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42291-144_090a2b62-2d72-7d03-069b-12bb45477099 42291-144 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130708 ANDA ANDA091624 AvKARE, Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42291-145_090a2b62-2d72-7d03-069b-12bb45477099 42291-145 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130708 ANDA ANDA091624 AvKARE, Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42291-146_090a2b62-2d72-7d03-069b-12bb45477099 42291-146 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130708 ANDA ANDA091624 AvKARE, Inc. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42291-158_2e17b783-fc07-fed3-f0a8-da618fcd6967 42291-158 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20140825 ANDA ANDA078220 AvKARE, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 42291-159_2e17b783-fc07-fed3-f0a8-da618fcd6967 42291-159 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20140825 ANDA ANDA077241 AvKARE, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 42291-160_b7260084-8ae9-642a-4b8f-d6879101d313 42291-160 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20090729 ANDA ANDA076820 AvKARE, Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 42291-161_b7260084-8ae9-642a-4b8f-d6879101d313 42291-161 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100729 ANDA ANDA076820 AvKARE, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 42291-162_b7260084-8ae9-642a-4b8f-d6879101d313 42291-162 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20090729 ANDA ANDA076820 AvKARE, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 42291-163_b7260084-8ae9-642a-4b8f-d6879101d313 42291-163 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20090729 ANDA ANDA076820 AvKARE, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 42291-168_14193044-7ce3-f458-1954-2aae1b47be84 42291-168 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20140113 ANDA ANDA076932 AvKARE, Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 42291-169_50dca1e3-7983-134c-824f-6fff9f0110a4 42291-169 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100401 ANDA ANDA040855 AvKARE, Inc. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 42291-170_50dca1e3-7983-134c-824f-6fff9f0110a4 42291-170 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100401 ANDA ANDA040855 AvKARE, Inc. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 42291-174_2f1d3045-0ff2-e8e6-a721-41f039c3cf54 42291-174 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20130401 ANDA ANDA203136 AvKARE, Inc. BUPRENORPHINE; NALOXONE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 42291-175_2f1d3045-0ff2-e8e6-a721-41f039c3cf54 42291-175 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20130401 ANDA ANDA203136 AvKARE, Inc. BUPRENORPHINE; NALOXONE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 42291-176_d1724a42-956e-3f33-3e04-b62eaf85ec35 42291-176 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20130828 ANDA ANDA075467 AvKARE, Inc. BUSPIRONE HYDROCHLORIDE 7.5 mg/1 42291-177_137a9486-9e0c-a8ec-b1c6-52f9194159c0 42291-177 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20131017 ANDA ANDA075022 AvKARE, Inc. BUSPIRONE HYDROCHLORIDE 30 mg/1 42291-181_662d87f7-910b-3398-c1e5-7e87bb13a2d6 42291-181 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine CAPSULE ORAL 20141124 ANDA ANDA040885 AvKARE, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 300; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 42291-192_48106600-8cd7-a01a-dd4b-340986f6e778 42291-192 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 AvKARE, Inc. CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-193_48106600-8cd7-a01a-dd4b-340986f6e778 42291-193 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 AvKARE, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-194_48106600-8cd7-a01a-dd4b-340986f6e778 42291-194 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 AvKARE, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-195_48106600-8cd7-a01a-dd4b-340986f6e778 42291-195 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 AvKARE, Inc. CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-196_59a26aef-eb5d-4146-9a7e-0cdaf24f4bec 42291-196 HUMAN PRESCRIPTION DRUG carvedilol carvedilol TABLET, FILM COATED ORAL 20140114 ANDA ANDA077346 AvKARE, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 42291-197_59a26aef-eb5d-4146-9a7e-0cdaf24f4bec 42291-197 HUMAN PRESCRIPTION DRUG carvedilol carvedilol TABLET, FILM COATED ORAL 20140114 ANDA ANDA077346 AvKARE, Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 42291-198_59a26aef-eb5d-4146-9a7e-0cdaf24f4bec 42291-198 HUMAN PRESCRIPTION DRUG carvedilol carvedilol TABLET, FILM COATED ORAL 20140114 ANDA ANDA077346 AvKARE, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 42291-199_59a26aef-eb5d-4146-9a7e-0cdaf24f4bec 42291-199 HUMAN PRESCRIPTION DRUG carvedilol carvedilol TABLET, FILM COATED ORAL 20140114 ANDA ANDA077346 AvKARE, Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 42291-200_7f8dc6b0-daf3-6991-2ef7-d1db51fb61eb 42291-200 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20110926 ANDA ANDA040823 AvKARE, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 42291-208_e29e8545-342f-0f62-ca96-73f6a3c20027 42291-208 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110811 ANDA ANDA062713 AvKARE, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42291-209_e29e8545-342f-0f62-ca96-73f6a3c20027 42291-209 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110811 ANDA ANDA062713 AvKARE, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42291-210_0629a0ad-ade8-9081-ddef-767583fb9936 42291-210 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20020926 ANDA ANDA085461 AvKARE, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42291-211_0629a0ad-ade8-9081-ddef-767583fb9936 42291-211 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20020926 ANDA ANDA085472 AvKARE, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42291-212_0629a0ad-ade8-9081-ddef-767583fb9936 42291-212 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20020926 ANDA ANDA085475 AvKARE, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42291-214_ed680384-d0f0-cde7-4861-ea346039c5e6 42291-214 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride/Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20131119 UNAPPROVED DRUG OTHER AvKARE, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] 42291-218_667d4974-dc65-1e3c-5a23-1f0aa3ec1051 42291-218 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20130723 ANDA ANDA074151 AvKARE, Inc. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 42291-219_9ee6c321-7d00-260a-2b1d-3dc99176665d 42291-219 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20140616 ANDA ANDA076126 AvKARE, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 42291-220_7627f366-b40a-57cf-d8c0-8d3f0c4da710 42291-220 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20130821 ANDA ANDA077498 AvKARE, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 42291-225_bcdabfc8-41d4-8f10-5d65-fd7bb4fa688a 42291-225 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20100615 ANDA ANDA040644 AvKARE, Inc. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 42291-226_67d75148-68ca-3263-423f-8613a0d90064 42291-226 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 20120703 ANDA ANDA078214 AvKARE, Inc. DANAZOL 50 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 42291-227_67d75148-68ca-3263-423f-8613a0d90064 42291-227 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 20120703 ANDA ANDA078214 AvKARE, Inc. DANAZOL 100 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 42291-228_67d75148-68ca-3263-423f-8613a0d90064 42291-228 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 20120703 ANDA ANDA077246 AvKARE, Inc. DANAZOL 200 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 42291-229_4da8d556-0c74-2ec0-8065-27b63898f78f 42291-229 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET ORAL 20120705 ANDA ANDA078355 AvKARE, Inc. DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 42291-230_ca0eb727-286c-e326-9e1d-126f19a0edc0 42291-230 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 AvKARE, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-231_ca0eb727-286c-e326-9e1d-126f19a0edc0 42291-231 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 AvKARE, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-232_59fe8b9a-221f-a848-bc86-ee843bb743b8 42291-232 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20121214 ANDA ANDA201089 AvKARE, Inc. DICLOFENAC SODIUM; MISOPROSTOL 50; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 42291-233_59fe8b9a-221f-a848-bc86-ee843bb743b8 42291-233 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20121214 ANDA ANDA201089 AvKARE, Inc. DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 42291-234_201650d3-2f6b-aaa6-5c13-8edff6813bd6 42291-234 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 20140103 ANDA ANDA070101 AvKARE, Inc. DISOPYRAMIDE PHOSPHATE 100 mg/1 Antiarrhythmic [EPC] 42291-235_201650d3-2f6b-aaa6-5c13-8edff6813bd6 42291-235 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 20140103 ANDA ANDA070102 AvKARE, Inc. DISOPYRAMIDE PHOSPHATE 150 mg/1 Antiarrhythmic [EPC] 42291-236_073ce4ac-f501-076c-4fe3-22a02e173b46 42291-236 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140109 ANDA ANDA075116 AvKARE, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 42291-237_073ce4ac-f501-076c-4fe3-22a02e173b46 42291-237 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140109 ANDA ANDA075116 AvKARE, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 42291-238_073ce4ac-f501-076c-4fe3-22a02e173b46 42291-238 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140603 ANDA ANDA075116 AvKARE, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 42291-239_073ce4ac-f501-076c-4fe3-22a02e173b46 42291-239 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140919 ANDA ANDA075116 AvKARE, Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 42291-244_7a678d53-d67d-9cbf-e229-eab14b716233 42291-244 HUMAN PRESCRIPTION DRUG Donnatal phenobarbital elixir ELIXIR ORAL 20140113 UNAPPROVED DRUG OTHER AvKARE, Inc. ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 42291-245_fa8f553a-c2ce-6b80-12ed-a078885dd6d9 42291-245 HUMAN PRESCRIPTION DRUG Donnatal Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide TABLET ORAL 20140106 UNAPPROVED DRUG OTHER AvKARE, Inc. ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 42291-247_5a19c0f2-d364-a551-1e59-68374c058969 42291-247 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20120831 ANDA ANDA071669 AvKARE, Inc. DOXEPIN HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 42291-248_87a134e4-e2ad-1fd3-f69b-1012d3132ef4 42291-248 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20130606 ANDA ANDA062677 AvKARE, Inc. DOXYCYCLINE HYCLATE 100 mg/1 42291-249_87a134e4-e2ad-1fd3-f69b-1012d3132ef4 42291-249 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20130723 ANDA ANDA062675 AvKARE, Inc. DOXYCYCLINE HYCLATE 50 mg/1 42291-250_87a134e4-e2ad-1fd3-f69b-1012d3132ef4 42291-250 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20130723 ANDA ANDA062676 AvKARE, Inc. DOXYCYCLINE HYCLATE 100 mg/1 42291-251_e0c2057b-8819-1ccd-8654-4bb2e415a5ae 42291-251 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140708 ANDA ANDA090776 AvKARE, Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-252_e0c2057b-8819-1ccd-8654-4bb2e415a5ae 42291-252 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140708 ANDA ANDA090776 AvKARE, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-253_e0c2057b-8819-1ccd-8654-4bb2e415a5ae 42291-253 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140708 ANDA ANDA090776 AvKARE, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-267_ca7ddd8c-1d54-3df5-e59e-71a7d2a69194 42291-267 HUMAN PRESCRIPTION DRUG Ergoloid Mesylates Dihydroergocornine Mesylate, Dihydroergocristine Mesylate, Dihydro-.alpha.-ergocryptine mesylate, and Dihydro-.beta.-ergocryptine mesylate TABLET ORAL 20140822 ANDA ANDA081113 AvKARE, Inc. DIHYDRO-.ALPHA.-ERGOCRYPTINE MESYLATE; DIHYDRO-.BETA.-ERGOCRYPTINE MESYLATE; DIHYDROERGOCORNINE MESYLATE; DIHYDROERGOCRISTINE MESYLATE .222; .111; .333; .333 mg/1; mg/1; mg/1; mg/1 42291-268_2456a3d6-8ea2-67b3-dacb-1a6ba2294b11 42291-268 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20140620 NDA AUTHORIZED GENERIC NDA020796 AvKARE, Inc. ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 42291-269_bfd2ae86-755a-c0c3-733a-3f2a7f8d380a 42291-269 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleate and Hydrochlorothiazide TABLET ORAL 20130722 ANDA ANDA075727 AvKARE, Inc. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-270_0e15c744-1ee1-363d-28ef-7e78acea5aca 42291-270 HUMAN PRESCRIPTION DRUG Epinastine HCl epinastine hydrochloride SOLUTION OPHTHALMIC 20111115 ANDA ANDA090870 AvKARE, Inc. EPINASTINE HYDROCHLORIDE .5 mg/mL Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 42291-271_5777d4d5-5ff6-c51c-e0a3-1641dd767d11 42291-271 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140515 ANDA ANDA091169 AvKARE, Inc. ESZOPICLONE 1 mg/1 CIV 42291-272_5777d4d5-5ff6-c51c-e0a3-1641dd767d11 42291-272 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140515 ANDA ANDA091169 AvKARE, Inc. ESZOPICLONE 2 mg/1 CIV 42291-273_5777d4d5-5ff6-c51c-e0a3-1641dd767d11 42291-273 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140515 ANDA ANDA091169 AvKARE, Inc. ESZOPICLONE 3 mg/1 CIV 42291-274_d9a26597-7fad-b72a-8457-c60690db8487 42291-274 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20120605 ANDA ANDA091004 AvKARE, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 42291-275_eeabed71-944a-e001-be49-b0d97813a2a7 42291-275 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20120104 ANDA ANDA077487 AvKARE, Inc. FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 42291-276_eeabed71-944a-e001-be49-b0d97813a2a7 42291-276 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20120104 ANDA ANDA077487 AvKARE, Inc. FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 42291-277_eeabed71-944a-e001-be49-b0d97813a2a7 42291-277 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20120104 ANDA ANDA077487 AvKARE, Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 42291-278_b21165bb-0d27-dcf6-e8ff-f47cd06ee803 42291-278 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride TABLET, FILM COATED ORAL 20120830 ANDA ANDA075755 AvKARE, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-279_b21165bb-0d27-dcf6-e8ff-f47cd06ee803 42291-279 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride TABLET, FILM COATED ORAL 20120830 ANDA ANDA075755 AvKARE, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-280_e2a2e915-312b-55d9-46b3-6d24ea4b2492 42291-280 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20130226 ANDA ANDA076511 AvKARE, Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 42291-281_832559de-19ef-e69c-547a-36c6b3f9b4f8 42291-281 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20130918 ANDA ANDA075805 AvKARE, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 42291-283_f16c5db4-d32c-df09-6d1b-f49cc2020173 42291-283 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL AURICULAR (OTIC) 20131218 ANDA ANDA091306 AvKARE, Inc. FLUOCINOLONE ACETONIDE .11 mg/20mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42291-284_106e5489-d635-7df0-8df4-f33020e395d3 42291-284 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL TOPICAL 20131217 ANDA ANDA201759 AvKARE, Inc. FLUOCINOLONE ACETONIDE .11 mg/118.28mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42291-285_f8397c3f-9b37-7f64-654e-79bd1983705f 42291-285 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL TOPICAL 20131217 ANDA ANDA201764 AvKARE, Inc. FLUOCINOLONE ACETONIDE .11 mg/118.28mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42291-286_7f1d2f15-0211-6ed2-7fb4-fd7755a08557 42291-286 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140331 ANDA ANDA075896 AvKARE, Inc. FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 42291-287_7f1d2f15-0211-6ed2-7fb4-fd7755a08557 42291-287 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140331 ANDA ANDA075896 AvKARE, Inc. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 42291-288_7f1d2f15-0211-6ed2-7fb4-fd7755a08557 42291-288 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140331 ANDA ANDA075896 AvKARE, Inc. FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 42291-300_d484042e-d2cd-8e59-08e8-a1edeb5096a9 42291-300 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20120504 ANDA ANDA078428 AvKARE, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42291-301_d484042e-d2cd-8e59-08e8-a1edeb5096a9 42291-301 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20120504 ANDA ANDA078428 AvKARE, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42291-302_d484042e-d2cd-8e59-08e8-a1edeb5096a9 42291-302 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20120504 ANDA ANDA078428 AvKARE, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42291-305_24cc5efd-029e-8261-53f0-2047468d3284 42291-305 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20130708 ANDA ANDA077270 AvKARE, Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 42291-306_24cc5efd-029e-8261-53f0-2047468d3284 42291-306 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20130708 ANDA ANDA077270 AvKARE, Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 42291-310_f99d00dc-8500-643f-e28d-c1f66b64b91d 42291-310 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine Hydrochloride TABLET ORAL 19981125 ANDA ANDA075109 AvKARE, Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 42291-311_f99d00dc-8500-643f-e28d-c1f66b64b91d 42291-311 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine Hydrochloride TABLET ORAL 19981125 ANDA ANDA075109 AvKARE, Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 42291-312_ecf961d2-dfd7-5011-45d6-197f3a8b1466 42291-312 HUMAN OTC DRUG GUAIFENESIN GUAIFENESIN TABLET ORAL 20120516 OTC MONOGRAPH FINAL part341 AvKARE, Inc. GUAIFENESIN 400 mg/1 42291-313_8888deda-bd70-1819-2d9b-7f5cf6077f98 42291-313 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET ORAL 20131104 OTC MONOGRAPH FINAL part341 AvKARE, Inc. GUAIFENESIN 200 mg/1 42291-316_8f457d51-e454-edcc-340f-326470bcabc0 42291-316 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20140925 ANDA ANDA074388 AvKARE, Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 42291-317_8f457d51-e454-edcc-340f-326470bcabc0 42291-317 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20140925 ANDA ANDA074388 AvKARE, Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 42291-318_d3294889-86bc-bcfc-f224-bd4de3a4e14a 42291-318 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20140519 ANDA ANDA040766 AvKARE, Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 42291-319_edf31c7d-0e6a-3048-7660-4711949eb7d0 42291-319 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20140128 ANDA ANDA040104 AvKARE, Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 42291-320_a93a4562-b230-a9f6-3e16-2ced0e1e09e8 42291-320 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET ORAL 20120229 ANDA ANDA040133 AvKARE, Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 42291-321_4f4032b3-82cd-b8b6-20fb-1474aee9f154 42291-321 HUMAN PRESCRIPTION DRUG HYDROXYUREA Hydroxyurea CAPSULE ORAL 20130719 ANDA ANDA075143 AvKARE, Inc. HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] 42291-322_b22c01cb-641a-7d71-5616-52b85df22d7b 42291-322 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20130307 ANDA ANDA040156 AvKARE, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 42291-323_b22c01cb-641a-7d71-5616-52b85df22d7b 42291-323 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20130307 ANDA ANDA040156 AvKARE, Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 42291-336_e1b85fb6-9e28-9ed0-bef5-e560b770859f 42291-336 HUMAN PRESCRIPTION DRUG Ibandronate Sodium ibandronate sodium TABLET ORAL 20131204 ANDA ANDA079003 AvKARE, Inc. IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 42291-337_44610af5-87da-8d4c-19e3-101695a2807b 42291-337 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20130110 ANDA ANDA078558 AvKARE, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-338_44610af5-87da-8d4c-19e3-101695a2807b 42291-338 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20130110 ANDA ANDA078558 AvKARE, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-339_44610af5-87da-8d4c-19e3-101695a2807b 42291-339 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20130110 ANDA ANDA078558 AvKARE, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-342_77b457f2-fbe6-393c-0d5e-4ee0d41740a3 42291-342 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20130926 ANDA ANDA077369 AvKARE, Inc. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-343_77b457f2-fbe6-393c-0d5e-4ee0d41740a3 42291-343 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20130926 ANDA ANDA077369 AvKARE, Inc. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-360_7e77cde8-d199-95f0-01d8-3d2ba128f54e 42291-360 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 20130708 ANDA ANDA073516 AvKARE, Inc. KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-361_7e77cde8-d199-95f0-01d8-3d2ba128f54e 42291-361 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 20130708 ANDA ANDA073517 AvKARE, Inc. KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-363_2f4b35da-3910-9da8-b0a5-11bcce1e35b6 42291-363 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20131016 ANDA ANDA079081 AvKARE, Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 42291-364_29507842-8ccd-f676-7e66-6beecb22fac9 42291-364 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130805 ANDA ANDA077255 AvKARE, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 42291-365_29507842-8ccd-f676-7e66-6beecb22fac9 42291-365 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130805 ANDA ANDA077255 AvKARE, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 42291-366_c8c34828-a331-f35d-d38f-cbc15f5f5bfd 42291-366 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130403 ANDA ANDA079132 AvKARE, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 42291-367_c8c34828-a331-f35d-d38f-cbc15f5f5bfd 42291-367 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130403 ANDA ANDA079132 AvKARE, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 42291-368_c8c34828-a331-f35d-d38f-cbc15f5f5bfd 42291-368 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130403 ANDA ANDA079132 AvKARE, Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 42291-369_c8c34828-a331-f35d-d38f-cbc15f5f5bfd 42291-369 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130403 ANDA ANDA079132 AvKARE, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 42291-370_09aa85f3-d88e-cd12-eeb8-bd00d8039826 42291-370 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20130712 ANDA ANDA076361 AvKARE, Inc. LEVOFLOXACIN 250 mg/1 42291-371_09aa85f3-d88e-cd12-eeb8-bd00d8039826 42291-371 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20130712 ANDA ANDA076361 AvKARE, Inc. LEVOFLOXACIN 500 mg/1 42291-372_09aa85f3-d88e-cd12-eeb8-bd00d8039826 42291-372 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20130712 ANDA ANDA076361 AvKARE, Inc. LEVOFLOXACIN 750 mg/1 42291-375_96594000-fd74-55dd-07ad-ef8db7a02374 42291-375 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20020606 ANDA ANDA075991 AvKARE, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42291-376_96594000-fd74-55dd-07ad-ef8db7a02374 42291-376 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20020606 ANDA ANDA075991 AvKARE, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42291-377_96594000-fd74-55dd-07ad-ef8db7a02374 42291-377 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20020606 ANDA ANDA075991 AvKARE, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42291-380_6583f7c1-40b6-c355-b007-81b868b1b28f 42291-380 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET ORAL 20051228 ANDA ANDA078106 AvKARE, Inc. LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42291-381_6583f7c1-40b6-c355-b007-81b868b1b28f 42291-381 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET ORAL 20051228 ANDA ANDA078106 AvKARE, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42291-382_6583f7c1-40b6-c355-b007-81b868b1b28f 42291-382 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET ORAL 20051228 ANDA ANDA078106 AvKARE, Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42291-383_6583f7c1-40b6-c355-b007-81b868b1b28f 42291-383 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET ORAL 20051228 ANDA ANDA078106 AvKARE, Inc. LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42291-390_6e7f7a9c-412a-b584-473e-747268402822 42291-390 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20130618 ANDA ANDA076262 AvKARE, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-391_6e7f7a9c-412a-b584-473e-747268402822 42291-391 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20130618 ANDA ANDA076262 AvKARE, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-392_6e7f7a9c-412a-b584-473e-747268402822 42291-392 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20130618 ANDA ANDA076262 AvKARE, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-393_9adaacbc-a020-dd33-4b4c-c8a05611451d 42291-393 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20141008 ANDA ANDA077157 AvKARE, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-394_9adaacbc-a020-dd33-4b4c-c8a05611451d 42291-394 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20141008 ANDA ANDA077157 AvKARE, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-395_9adaacbc-a020-dd33-4b4c-c8a05611451d 42291-395 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20141008 ANDA ANDA077157 AvKARE, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-509_5d368e91-0f11-5d3a-4df9-9659cdb7e362 42291-509 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20080424 ANDA ANDA040866 AvKARE, Inc. PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42291-511_5d368e91-0f11-5d3a-4df9-9659cdb7e362 42291-511 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20080424 ANDA ANDA040866 AvKARE, Inc. PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42291-526_4da66c17-f47d-0fb3-c8da-18a581119dbe 42291-526 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20070708 ANDA ANDA040782 AvKARE, Inc. DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 42291-527_4da66c17-f47d-0fb3-c8da-18a581119dbe 42291-527 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20070708 ANDA ANDA040782 AvKARE, Inc. DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 42291-528_4da66c17-f47d-0fb3-c8da-18a581119dbe 42291-528 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20070708 ANDA ANDA040782 AvKARE, Inc. DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 42291-529_f3d0df97-37f8-fef8-28c6-fc123d6aae39 42291-529 HUMAN PRESCRIPTION DRUG FLUDROCORTISONE ACETATE FLUDROCORTISONE ACETATE TABLET ORAL 20020318 ANDA ANDA040431 AvKARE, Inc. FLUDROCORTISONE ACETATE .1 mg/1 42291-530_e5f68879-b38b-baa8-690e-f5e4c0b365db 42291-530 HUMAN PRESCRIPTION DRUG ORPHENADRINE CITRATE ORPHENADRINE CITRATE TABLET ORAL 20000624 ANDA ANDA040368 AvKARE, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 42291-531_593f3040-93e0-9248-bef4-c01c20863194 42291-531 HUMAN PRESCRIPTION DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET ORAL 20070426 ANDA ANDA078432 AvKARE, Inc. NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-532_593f3040-93e0-9248-bef4-c01c20863194 42291-532 HUMAN PRESCRIPTION DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET ORAL 20070426 ANDA ANDA078432 AvKARE, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-550_46a544f6-f4a1-4877-a07a-484a42c84644 42291-550 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 19970101 ANDA ANDA080154 AvKARE, Inc. PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 42291-592_e9a5131b-4f13-4daf-6a65-eb5b8be9d6d0 42291-592 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141204 ANDA ANDA090692 AvKARE, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 42291-593_e9a5131b-4f13-4daf-6a65-eb5b8be9d6d0 42291-593 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141204 ANDA ANDA090692 AvKARE, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 42291-594_21472ac3-427e-318a-c100-dd15b03e8736 42291-594 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate TABLET ORAL 20141120 ANDA ANDA081099 AvKARE, Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 42291-595_f86688c7-ac81-7651-de50-1f3f37fd163b 42291-595 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20140930 ANDA ANDA072801 AvKARE, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 42291-596_f86688c7-ac81-7651-de50-1f3f37fd163b 42291-596 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20140930 ANDA ANDA070184 AvKARE, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 42291-597_6edff50f-c38a-2ee4-d9af-55231111341a 42291-597 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20140919 ANDA ANDA077918 AvKARE, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-598_6edff50f-c38a-2ee4-d9af-55231111341a 42291-598 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20140919 ANDA ANDA077918 AvKARE, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-599_529443f8-22dd-9a95-a241-1c5ff217d51b 42291-599 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20140224 ANDA ANDA076715 AvKARE, Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 42291-600_529443f8-22dd-9a95-a241-1c5ff217d51b 42291-600 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20140224 ANDA ANDA076715 AvKARE, Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 42291-601_06cfa7ff-e4d0-626a-049d-610094c739ce 42291-601 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141001 ANDA ANDA091695 AvKARE, Inc. METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 42291-602_06cfa7ff-e4d0-626a-049d-610094c739ce 42291-602 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141001 ANDA ANDA091695 AvKARE, Inc. METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 42291-603_06cfa7ff-e4d0-626a-049d-610094c739ce 42291-603 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141001 ANDA ANDA091695 AvKARE, Inc. METHYLPHENIDATE HYDROCHLORIDE 36 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 42291-604_06cfa7ff-e4d0-626a-049d-610094c739ce 42291-604 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141001 ANDA ANDA091695 AvKARE, Inc. METHYLPHENIDATE HYDROCHLORIDE 54 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 42291-605_814d3c6a-c357-fc0c-b899-d69c98eb7e44 42291-605 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20120626 ANDA ANDA077880 AvKARE, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 42291-606_814d3c6a-c357-fc0c-b899-d69c98eb7e44 42291-606 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20120626 ANDA ANDA077880 AvKARE, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 42291-607_814d3c6a-c357-fc0c-b899-d69c98eb7e44 42291-607 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20120626 ANDA ANDA077880 AvKARE, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 42291-608_614ecd56-b955-cb6d-d73b-20be06aacc58 42291-608 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20120504 ANDA ANDA201451 AvKARE, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 42291-609_614ecd56-b955-cb6d-d73b-20be06aacc58 42291-609 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120504 ANDA ANDA201451 AvKARE, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 42291-610_d6d7e20d-d90c-8125-cab6-d128f8d3dc12 42291-610 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091202 ANDA ANDA078596 AvKARE, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 42291-611_d6d7e20d-d90c-8125-cab6-d128f8d3dc12 42291-611 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091202 ANDA ANDA078596 AvKARE, Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 42291-615_c63c23ed-0f62-08d5-9bf5-c8939c69220c 42291-615 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20040527 ANDA ANDA076449 AvKARE, Inc. MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 42291-616_c63c23ed-0f62-08d5-9bf5-c8939c69220c 42291-616 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20040527 ANDA ANDA076449 AvKARE, Inc. MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 42291-617_c63c23ed-0f62-08d5-9bf5-c8939c69220c 42291-617 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20051227 ANDA ANDA076449 AvKARE, Inc. MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 42291-618_ad0ed73a-519f-44b8-f4d1-be1d490d6a3d 42291-618 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 20130801 ANDA ANDA072708 AvKARE, Inc. MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 42291-619_ad0ed73a-519f-44b8-f4d1-be1d490d6a3d 42291-619 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 20130801 ANDA ANDA072709 AvKARE, Inc. MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 42291-620_f17b8cdb-0f38-b327-85e9-64381817dd81 42291-620 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20110726 ANDA ANDA065062 AvKARE, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 42291-621_7ee94824-05a6-cd3d-ee22-8916ad38c4ab 42291-621 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120810 ANDA ANDA201522 AvKARE, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 42291-622_7ee94824-05a6-cd3d-ee22-8916ad38c4ab 42291-622 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20130102 ANDA ANDA200405 AvKARE, Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 42291-623_7ee94824-05a6-cd3d-ee22-8916ad38c4ab 42291-623 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20130102 ANDA ANDA200405 AvKARE, Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 42291-624_b1fbaf51-0752-96de-3790-c7d3b02ea62c 42291-624 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 20130709 ANDA ANDA074377 AvKARE, Inc. MEXILETINE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] 42291-625_b1fbaf51-0752-96de-3790-c7d3b02ea62c 42291-625 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 20130709 ANDA ANDA074377 AvKARE, Inc. MEXILETINE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC] 42291-626_b1fbaf51-0752-96de-3790-c7d3b02ea62c 42291-626 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 20130709 ANDA ANDA074377 AvKARE, Inc. MEXILETINE HYDROCHLORIDE 250 mg/1 Antiarrhythmic [EPC] 42291-627_2bb57488-286f-4d1b-8ed5-a404f0c982b7 42291-627 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20130730 ANDA ANDA076037 AvKARE, Inc. NEFAZODONE HYDROCHLORIDE 250 mg/1 Serotonin Reuptake Inhibitor [EPC] 42291-628_dba004aa-2103-bf7a-a1ca-8611696fca88 42291-628 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20130926 ANDA ANDA075927 AvKARE, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-629_970dc7a9-4bea-90be-9a0e-da94e7efdee6 42291-629 HUMAN PRESCRIPTION DRUG Naproxen delayed release Naproxen TABLET ORAL 20131024 ANDA ANDA091432 AvKARE, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-630_970dc7a9-4bea-90be-9a0e-da94e7efdee6 42291-630 HUMAN PRESCRIPTION DRUG Naproxen delayed release Naproxen TABLET ORAL 20131024 ANDA ANDA091432 AvKARE, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-631_2bb57488-286f-4d1b-8ed5-a404f0c982b7 42291-631 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20131216 ANDA ANDA076037 AvKARE, Inc. NEFAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 42291-638_96ba6aa3-d932-7b1e-8370-31e4690f7f58 42291-638 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20140120 ANDA ANDA075189 AvKARE, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-639_96ba6aa3-d932-7b1e-8370-31e4690f7f58 42291-639 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20140120 ANDA ANDA075189 AvKARE, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-640_38533cfc-f514-4831-6b27-3b5b289553dd 42291-640 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride CAPSULE ORAL 20100505 ANDA ANDA074928 AvKARE, Inc. NICARDIPINE HYDROCHLORIDE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 42291-641_38533cfc-f514-4831-6b27-3b5b289553dd 42291-641 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride CAPSULE ORAL 20100505 ANDA ANDA074928 AvKARE, Inc. NICARDIPINE HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 42291-642_d4c0063c-25db-6502-3929-690dba132d01 42291-642 HUMAN PRESCRIPTION DRUG NP Thyroid 30 LEVOTHYROXINE, LIOTHYRONINE TABLET TOPICAL 20140523 UNAPPROVED DRUG OTHER AvKARE, Inc. LEVOTHYROXINE; LIOTHYRONINE 19; 4.5 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 42291-643_d4c0063c-25db-6502-3929-690dba132d01 42291-643 HUMAN PRESCRIPTION DRUG NP Thyroid 60 LEVOTHYROXINE, LIOTHYRONINE TABLET TOPICAL 20140523 UNAPPROVED DRUG OTHER AvKARE, Inc. LEVOTHYROXINE; LIOTHYRONINE 38; 9 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 42291-644_d4c0063c-25db-6502-3929-690dba132d01 42291-644 HUMAN PRESCRIPTION DRUG NP Thyroid 90 LEVOTHYROXINE, LIOTHYRONINE TABLET TOPICAL 20140523 UNAPPROVED DRUG OTHER AvKARE, Inc. LEVOTHYROXINE; LIOTHYRONINE 57; 13.5 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 42291-648_949f431e-88fa-2b22-0e04-a27e21b83718 42291-648 HUMAN PRESCRIPTION DRUG Nitroglycerin ER Nitroglycerin CAPSULE ORAL 20121219 UNAPPROVED DRUG OTHER AvKARE, Inc. NITROGLYCERIN 2.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 42291-649_949f431e-88fa-2b22-0e04-a27e21b83718 42291-649 HUMAN PRESCRIPTION DRUG Nitroglycerin ER Nitroglycerin CAPSULE ORAL 20121219 UNAPPROVED DRUG OTHER AvKARE, Inc. NITROGLYCERIN 6.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 42291-650_5b385c36-967e-f727-d211-0f20f615117c 42291-650 HUMAN PRESCRIPTION DRUG Norethindrone Acetate Norethindrone TABLET ORAL 20130618 ANDA ANDA200275 AvKARE, Inc. NORETHINDRONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 42291-651_d5102fe5-d5ac-f335-7783-b60d33a6c88d 42291-651 HUMAN PRESCRIPTION DRUG Nystatin Nystatin TABLET, FILM COATED ORAL 20140120 ANDA ANDA062506 AvKARE, Inc. NYSTATIN 500000 [USP'U]/1 Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 42291-652_5a7cc904-7edf-b033-d2f9-b6308899a8cf 42291-652 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20140121 ANDA ANDA202074 AvKARE, Inc. FLUOXETINE HYDROCHLORIDE; OLANZAPINE 25; 3 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-653_5a7cc904-7edf-b033-d2f9-b6308899a8cf 42291-653 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20140121 ANDA ANDA077528 AvKARE, Inc. FLUOXETINE HYDROCHLORIDE; OLANZAPINE 25; 6 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-654_5a7cc904-7edf-b033-d2f9-b6308899a8cf 42291-654 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20140121 ANDA ANDA077528 AvKARE, Inc. FLUOXETINE HYDROCHLORIDE; OLANZAPINE 50; 6 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-655_5a7cc904-7edf-b033-d2f9-b6308899a8cf 42291-655 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20140121 ANDA ANDA077528 AvKARE, Inc. FLUOXETINE HYDROCHLORIDE; OLANZAPINE 25; 12 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-656_5a7cc904-7edf-b033-d2f9-b6308899a8cf 42291-656 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20140121 ANDA ANDA077528 AvKARE, Inc. FLUOXETINE HYDROCHLORIDE; OLANZAPINE 50; 12 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-661_bce26ce7-50fa-8ff3-23ba-7360dde69275 42291-661 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine SUSPENSION ORAL 20140123 ANDA ANDA202961 AvKARE, Inc. OXCARBAZEPINE 300 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42291-662_77d29f8f-b000-c7df-512f-6f177d0535b6 42291-662 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET ORAL 20140306 ANDA ANDA075844 AvKARE, Inc. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-665_3fc0b794-07ac-72d2-b581-4b359c1eb882 42291-665 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20140617 ANDA ANDA076056 AvKARE, Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42291-667_3fc0b794-07ac-72d2-b581-4b359c1eb882 42291-667 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20140617 ANDA ANDA076056 AvKARE, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42291-668_3fc0b794-07ac-72d2-b581-4b359c1eb882 42291-668 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20140617 ANDA ANDA076056 AvKARE, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42291-669_3fc0b794-07ac-72d2-b581-4b359c1eb882 42291-669 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20140617 ANDA ANDA077793 AvKARE, Inc. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42291-670_a26b90d2-4780-47d8-e70c-a6f8b7b633ec 42291-670 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20140324 UNAPPROVED DRUG OTHER AvKARE, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 42291-671_a26b90d2-4780-47d8-e70c-a6f8b7b633ec 42291-671 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20140324 UNAPPROVED DRUG OTHER AvKARE, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 42291-672_e69a4519-d59d-380c-7da4-0f8389f4ca6e 42291-672 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20140507 ANDA ANDA076368 AvKARE, Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 42291-673_4b9f1cfd-7559-bbcd-1efa-4b3b87ea1d9c 42291-673 HUMAN PRESCRIPTION DRUG POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 POWDER ORAL 20130705 ANDA ANDA076652 AvKARE, Inc. POLYETHYLENE GLYCOL 3350 1 g/g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 42291-674_c24c87a6-1aba-a9a5-230a-806152eab10b 42291-674 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20130627 ANDA ANDA074131 AvKARE, Inc. PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-677_c24c87a6-1aba-a9a5-230a-806152eab10b 42291-677 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20121128 ANDA ANDA074131 AvKARE, Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-678_a49f5b38-8759-418c-8c0d-10faebe7264c 42291-678 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20130305 ANDA ANDA077419 AvKARE, Inc. POTASSIUM CHLORIDE 8 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 42291-679_a49f5b38-8759-418c-8c0d-10faebe7264c 42291-679 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20130305 ANDA ANDA077419 AvKARE, Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 42291-680_7afc28ec-2843-adcd-127a-228ccfc61330 42291-680 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20130905 ANDA ANDA091450 AvKARE, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 42291-681_7afc28ec-2843-adcd-127a-228ccfc61330 42291-681 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20130905 ANDA ANDA091450 AvKARE, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 42291-682_7afc28ec-2843-adcd-127a-228ccfc61330 42291-682 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20130905 ANDA ANDA091450 AvKARE, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 42291-683_7afc28ec-2843-adcd-127a-228ccfc61330 42291-683 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20130905 ANDA ANDA091450 AvKARE, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 42291-684_7afc28ec-2843-adcd-127a-228ccfc61330 42291-684 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20130905 ANDA ANDA091450 AvKARE, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 42291-685_ca097602-217f-33e1-cb31-1f8fb17f4d24 42291-685 HUMAN PRESCRIPTION DRUG Probenecid and Colchicine Probenecid and Colchicine TABLET ORAL 20120508 ANDA ANDA040618 AvKARE, Inc. COLCHICINE; PROBENECID .5; 500 mg/1; mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 42291-686_711ebe63-51f3-3e71-cb32-e413e1faf11d 42291-686 HUMAN PRESCRIPTION DRUG PRENATAL PLUS VITAMIN A ACETATE, BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE TABLET, FILM COATED ORAL 20120911 UNAPPROVED DRUG OTHER AvKARE, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE 22; 920; 120; 200; 400; 2; 12; 27; 1; 20; 10; 3; 1.84; 3080; 25 mg/1; [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC] 42291-687_b63f5278-d58f-3240-2399-5448a0706b65 42291-687 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, EXTENDED RELEASE ORAL 20130731 ANDA ANDA075028 AvKARE, Inc. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 42291-688_7b883565-394b-c20b-cbad-cfe07aa425bd 42291-688 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20130604 ANDA ANDA200456 AvKARE, Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 42291-689_7b883565-394b-c20b-cbad-cfe07aa425bd 42291-689 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20130604 ANDA ANDA200456 AvKARE, Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 42291-690_e9de144a-05e1-7b65-710d-14828510169d 42291-690 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20140929 ANDA ANDA200900 AvKARE, Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 42291-691_e9de144a-05e1-7b65-710d-14828510169d 42291-691 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20140929 ANDA ANDA200900 AvKARE, Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 42291-693_7a88dcc3-8d44-68e2-9b22-887c6a0afe75 42291-693 HUMAN PRESCRIPTION DRUG Pioglitazone and Metformin Hydrocholride pioglitazone and metformin hydrochloride TABLET, FILM COATED ORAL 20140501 NDA AUTHORIZED GENERIC NDA021842 AvKARE, Inc. METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 42291-694_7a88dcc3-8d44-68e2-9b22-887c6a0afe75 42291-694 HUMAN PRESCRIPTION DRUG Pioglitazone and Metformin Hydrocholride pioglitazone and metformin hydrochloride TABLET, FILM COATED ORAL 20140501 NDA AUTHORIZED GENERIC NDA021842 AvKARE, Inc. METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 42291-695_34732594-3199-40d9-15fd-8806907b3c88 42291-695 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20140117 ANDA ANDA077745 AvKARE, Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 42291-696_34732594-3199-40d9-15fd-8806907b3c88 42291-696 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20140117 ANDA ANDA077745 AvKARE, Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 42291-697_34732594-3199-40d9-15fd-8806907b3c88 42291-697 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20140117 ANDA ANDA077745 AvKARE, Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 42291-698_34732594-3199-40d9-15fd-8806907b3c88 42291-698 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20140117 ANDA ANDA077745 AvKARE, Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 42291-699_34732594-3199-40d9-15fd-8806907b3c88 42291-699 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20140117 ANDA ANDA077745 AvKARE, Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 42291-700_34732594-3199-40d9-15fd-8806907b3c88 42291-700 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20140117 ANDA ANDA077745 AvKARE, Inc. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 42291-701_ae33cee2-5f21-8ee5-b562-cddb77c436a3 42291-701 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20120802 ANDA ANDA078457 AvKARE, Inc. QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 42291-702_ae33cee2-5f21-8ee5-b562-cddb77c436a3 42291-702 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20120802 ANDA ANDA078457 AvKARE, Inc. QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 42291-703_ae33cee2-5f21-8ee5-b562-cddb77c436a3 42291-703 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20120802 ANDA ANDA078457 AvKARE, Inc. QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 42291-704_ae33cee2-5f21-8ee5-b562-cddb77c436a3 42291-704 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20120802 ANDA ANDA078457 AvKARE, Inc. QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 42291-705_a0a026c2-eb12-9553-dbdc-97e07061f48a 42291-705 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET ORAL 20120802 ANDA ANDA201356 AvKARE, Inc. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-706_a0a026c2-eb12-9553-dbdc-97e07061f48a 42291-706 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET ORAL 20120802 ANDA ANDA201356 AvKARE, Inc. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-707_a0a026c2-eb12-9553-dbdc-97e07061f48a 42291-707 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET ORAL 20120802 ANDA ANDA201356 AvKARE, Inc. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-708_d7d5de26-8264-97b7-a352-cd3c19379040 42291-708 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120628 ANDA ANDA200431 AvKARE, Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 42291-709_d7d5de26-8264-97b7-a352-cd3c19379040 42291-709 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120628 ANDA ANDA200431 AvKARE, Inc. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 42291-710_d7d5de26-8264-97b7-a352-cd3c19379040 42291-710 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120628 ANDA ANDA200431 AvKARE, Inc. ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 42291-711_d7d5de26-8264-97b7-a352-cd3c19379040 42291-711 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120628 ANDA ANDA200431 AvKARE, Inc. ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 42291-712_d7d5de26-8264-97b7-a352-cd3c19379040 42291-712 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120628 ANDA ANDA200431 AvKARE, Inc. ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 42291-713_6df15e58-ed64-edb8-6753-860cb4acdda8 42291-713 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130913 ANDA ANDA090869 AvKARE, Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 42291-714_6df15e58-ed64-edb8-6753-860cb4acdda8 42291-714 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130913 ANDA ANDA090869 AvKARE, Inc. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 42291-715_6df15e58-ed64-edb8-6753-860cb4acdda8 42291-715 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130913 ANDA ANDA090869 AvKARE, Inc. ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 42291-716_6df15e58-ed64-edb8-6753-860cb4acdda8 42291-716 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130913 ANDA ANDA090869 AvKARE, Inc. ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 42291-717_6df15e58-ed64-edb8-6753-860cb4acdda8 42291-717 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130913 ANDA ANDA090869 AvKARE, Inc. ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 42291-718_62289538-5e72-f413-8c60-91b62f521273 42291-718 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin CAPSULE ORAL 20140117 ANDA ANDA076277 AvKARE, Inc. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 42291-719_332995b4-b564-94b8-7e36-276441592936 42291-719 HUMAN PRESCRIPTION DRUG REPAGLINIDE repaglinide TABLET ORAL 20131212 ANDA ANDA077571 AvKARE, Inc. REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 42291-720_332995b4-b564-94b8-7e36-276441592936 42291-720 HUMAN PRESCRIPTION DRUG REPAGLINIDE repaglinide TABLET ORAL 20131212 ANDA ANDA077571 AvKARE, Inc. REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 42291-721_d82e3cc9-d539-857d-b4e0-a584503bc403 42291-721 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole Sodium TABLET, DELAYED RELEASE ORAL 20131223 ANDA ANDA076822 AvKARE, Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 42291-722_39b816f4-f4c1-4c2f-77c6-2d444e8b9a10 42291-722 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole Sodium TABLET, DELAYED RELEASE ORAL 20131219 ANDA ANDA090678 AvKARE, Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 42291-723_aeed1cd6-e7f1-8351-cdcd-8691e325b643 42291-723 HUMAN PRESCRIPTION DRUG Riluzole riluzole TABLET, FILM COATED ORAL 20140108 NDA AUTHORIZED GENERIC NDA020599 AvKARE, Inc. RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] 42291-724_c40048b3-57a0-dc63-6111-ecf144c03d27 42291-724 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20140818 ANDA ANDA077824 AvKARE, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 42291-725_c40048b3-57a0-dc63-6111-ecf144c03d27 42291-725 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20140818 ANDA ANDA077824 AvKARE, Inc. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 42291-726_8672bbe5-708b-9ff1-1b14-c41165d0019d 42291-726 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET, FILM COATED ORAL 20141103 ANDA ANDA078193 AvKARE, Inc. RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 42291-730_32029952-3381-5f32-8178-9e4434957096 42291-730 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20130917 ANDA ANDA078380 AvKARE, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 42291-750_29ea8356-b95f-8659-0d4a-31cdd577729a 42291-750 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20100125 ANDA ANDA072710 AvKARE, Inc. SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-751_29ea8356-b95f-8659-0d4a-31cdd577729a 42291-751 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20100125 ANDA ANDA072711 AvKARE, Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42291-755_fcc47afc-f65f-6c83-7c4f-a9cb984ab578 42291-755 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20130517 UNAPPROVED DRUG OTHER AvKARE, Inc. SALSALATE 500 mg/1 42291-756_fcc47afc-f65f-6c83-7c4f-a9cb984ab578 42291-756 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20130517 UNAPPROVED DRUG OTHER AvKARE, Inc. SALSALATE 750 mg/1 42291-757_e91b5106-94a6-e454-b03e-275cc5eaa2be 42291-757 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20140117 ANDA ANDA070848 AvKARE, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 42291-760_52ad61a0-3d90-3fb6-30d9-b30b9eb496b6 42291-760 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20140213 ANDA ANDA076214 AvKARE, Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 42291-761_52ad61a0-3d90-3fb6-30d9-b30b9eb496b6 42291-761 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20140213 ANDA ANDA076214 AvKARE, Inc. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC] 42291-762_52ad61a0-3d90-3fb6-30d9-b30b9eb496b6 42291-762 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20140213 ANDA ANDA076214 AvKARE, Inc. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC] 42291-801_6f3e6c8f-9374-de1e-f943-6483c2a1a1c4 42291-801 HUMAN PRESCRIPTION DRUG TERBUTALINE SULFATE TERBUTALINE SULFATE TABLET ORAL 20010626 ANDA ANDA075877 AvKARE, Inc. TERBUTALINE SULFATE 2.5 mg/1 42291-802_6f3e6c8f-9374-de1e-f943-6483c2a1a1c4 42291-802 HUMAN PRESCRIPTION DRUG TERBUTALINE SULFATE TERBUTALINE SULFATE TABLET ORAL 20010626 ANDA ANDA075877 AvKARE, Inc. TERBUTALINE SULFATE 5 mg/1 42291-803_342b8526-6a7a-7313-8ed8-c0fc8fc5f91b 42291-803 HUMAN PRESCRIPTION DRUG Ticlopidine Hydrochloride Ticlopidine Hydrochloride TABLET, FILM COATED ORAL 20140320 ANDA ANDA075149 AvKARE, Inc. TICLOPIDINE HYDROCHLORIDE 250 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 42291-805_43747a98-54a7-0a0d-9c8c-fd117c3b095c 42291-805 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20111020 ANDA ANDA077919 AvKARE, Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 42291-810_7a74c21c-593c-c3aa-9f3d-16c338fa86d8 42291-810 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride CAPSULE, GELATIN COATED ORAL 20140620 ANDA ANDA078868 AvKARE, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 42291-811_7a74c21c-593c-c3aa-9f3d-16c338fa86d8 42291-811 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride CAPSULE, GELATIN COATED ORAL 20140620 ANDA ANDA078868 AvKARE, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 42291-812_7a74c21c-593c-c3aa-9f3d-16c338fa86d8 42291-812 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride CAPSULE, GELATIN COATED ORAL 20140620 ANDA ANDA078868 AvKARE, Inc. TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 42291-819_52018609-59bf-89e9-99cb-af0c9fb37cbf 42291-819 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20141229 ANDA ANDA076346 AvKARE, Inc. TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 42291-833_885df62e-cfe9-4d0b-80f1-b71d17c8026d 42291-833 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20140206 ANDA ANDA071523 AvKARE, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 42291-834_885df62e-cfe9-4d0b-80f1-b71d17c8026d 42291-834 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20140206 ANDA ANDA071524 AvKARE, Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 42291-835_885df62e-cfe9-4d0b-80f1-b71d17c8026d 42291-835 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20140206 ANDA ANDA071525 AvKARE, Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 42291-836_885df62e-cfe9-4d0b-80f1-b71d17c8026d 42291-836 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20140206 ANDA ANDA071196 AvKARE, Inc. TRAZODONE HYDROCHLORIDE 300 mg/1 Serotonin Reuptake Inhibitor [EPC] 42291-837_631f9843-a83a-7002-9a5c-8fdf8de439e2 42291-837 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20130730 ANDA ANDA077489 AvKARE, Inc. TRANDOLAPRIL 1 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 42291-838_631f9843-a83a-7002-9a5c-8fdf8de439e2 42291-838 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20130730 ANDA ANDA077489 AvKARE, Inc. TRANDOLAPRIL 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 42291-839_631f9843-a83a-7002-9a5c-8fdf8de439e2 42291-839 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20130730 ANDA ANDA077489 AvKARE, Inc. TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 42291-840_d7d7c8a6-2a51-600c-ba60-834064dc9c4f 42291-840 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE TOPICAL 20120328 ANDA ANDA040771 AvKARE, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g 42291-841_a8d35027-e44e-cd73-2a95-53a026ebc6db 42291-841 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 20120703 ANDA ANDA201407 AvKARE, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-842_3e4a2c3a-20db-967c-c6b7-7017fc7414e0 42291-842 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20141014 ANDA ANDA071251 AvKARE, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-845_c6170d17-0d72-3029-7424-04b869a66738 42291-845 HUMAN PRESCRIPTION DRUG Trimethoprim trimethoprim TABLET ORAL 20130506 ANDA ANDA091437 AvKARE, Inc. TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 42291-850_d20ceccb-8f8c-6773-0b4d-d0e4480e5661 42291-850 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20100716 ANDA ANDA075517 AvKARE, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 42291-884_4ab027c0-8739-11fa-3a07-fb0e86ad9659 42291-884 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20140908 ANDA ANDA091519 AvKARE, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-885_4ab027c0-8739-11fa-3a07-fb0e86ad9659 42291-885 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20140908 ANDA ANDA091519 AvKARE, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-886_4ab027c0-8739-11fa-3a07-fb0e86ad9659 42291-886 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20140908 ANDA ANDA091519 AvKARE, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-887_4ab027c0-8739-11fa-3a07-fb0e86ad9659 42291-887 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20140908 ANDA ANDA091519 AvKARE, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-888_4ab027c0-8739-11fa-3a07-fb0e86ad9659 42291-888 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20140908 ANDA ANDA091519 AvKARE, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42291-889_f8ac9647-7644-6520-5147-dc87e2db7b7d 42291-889 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20130711 ANDA ANDA077655 AvKARE, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 42291-892_765fbd6a-3172-a8d1-ff9e-d75bac58a648 42291-892 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20120507 ANDA ANDA079098 AvKARE, Inc. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-893_765fbd6a-3172-a8d1-ff9e-d75bac58a648 42291-893 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20120507 ANDA ANDA079098 AvKARE, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-894_765fbd6a-3172-a8d1-ff9e-d75bac58a648 42291-894 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20120507 ANDA ANDA079098 AvKARE, Inc. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-895_765fbd6a-3172-a8d1-ff9e-d75bac58a648 42291-895 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20120507 ANDA ANDA079098 AvKARE, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-896_765fbd6a-3172-a8d1-ff9e-d75bac58a648 42291-896 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20120507 ANDA ANDA079098 AvKARE, Inc. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-897_b9390758-d291-8a10-e1b4-503c236c7cca 42291-897 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130710 ANDA ANDA076565 AvKARE, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-898_b9390758-d291-8a10-e1b4-503c236c7cca 42291-898 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130710 ANDA ANDA076565 AvKARE, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42291-899_b9390758-d291-8a10-e1b4-503c236c7cca 42291-899 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130710 ANDA ANDA076565 AvKARE, Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42302-010_c117d526-ac65-4322-a24e-1634860a7142 42302-010 HUMAN OTC DRUG Antibacterial Hand - Aloe Vera TRICLOSAN SOAP TOPICAL 20120125 OTC MONOGRAPH FINAL part333E Lonkey Overseas Inc. TRICLOSAN .15 mL/100mL 42302-011_01d771d9-d830-4c20-b4c9-3cf42f17381c 42302-011 HUMAN OTC DRUG Antibacterial Hand -Vanilla Brown Sugar TRICLOSAN SOAP TOPICAL 20120125 OTC MONOGRAPH FINAL part333E Lonkey Overseas Inc. TRICLOSAN .15 mL/100mL 42302-030_a3b907bc-37cb-497f-ba87-51680230ecc7 42302-030 HUMAN OTC DRUG Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120125 OTC MONOGRAPH FINAL part333E Lonkey Overseas Inc. ALCOHOL 62 mL/100mL 42311-001_702b02e3-1050-42ee-bc0a-7770e152137d 42311-001 HUMAN OTC DRUG Antibacterial Multifold Towels Benzalkonium Chloride CLOTH TOPICAL 20120611 OTC MONOGRAPH NOT FINAL part333E Cascades Tissue Group Inc. BENZALKONIUM CHLORIDE 3.3 mg/1 42311-002_20d28a69-92b5-4172-8f27-7961aa4776cc 42311-002 HUMAN OTC DRUG Antibacterial singlefold Towels Benzalkonium Chloride CLOTH TOPICAL 20120611 OTC MONOGRAPH NOT FINAL part333E Cascades Tissue Group Inc. BENZALKONIUM CHLORIDE 3.3 mg/1 42311-003_749b9093-ff74-40c0-9c0b-8127be2c3eff 42311-003 HUMAN OTC DRUG Antibacterial Roll Towels Benzalkonium Chloride CLOTH TOPICAL 20120611 OTC MONOGRAPH NOT FINAL part333E Cascades Tissue Group Inc. BENZALKONIUM CHLORIDE 3.3 mg/1 42315-002_cff5765a-8c6e-4d5b-97c8-40f5df9bf8f6 42315-002 HUMAN OTC DRUG Eshu Skin Assist SPF 30 Moisturising Sunscreen Homosalate, Octisalate, Avobenzone, Octocrylene LOTION TOPICAL 20110401 OTC MONOGRAPH FINAL part352 Eshu Pty. Ltd. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 8; 4; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 42315-672_76f453cb-70e0-4b82-ae7f-773d45197ed1 42315-672 HUMAN OTC DRUG moisturising sunscreen SPF 30 Homosalate, Octisalate, Octinoxate, Octocrylene CREAM TOPICAL 20110217 OTC MONOGRAPH NOT FINAL part352 Eshu Pty Ltd HOMOSALATE; OCTINOXATE; OCTISALATE 8; 3; 4 mL/100mL; mL/100mL; mL/100mL 42333-100_2b62494d-2094-48f5-b4e0-9e7b5232afa5 42333-100 HUMAN OTC DRUG Borasol Eucalyptol, Thymol, Methyl Salicylate, Menthol POWDER TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part356 Laboratorios Dr. Collado, C x A. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .091; .01; .055; .063 g/100g; g/100g; g/100g; g/100g 42333-101_9041014f-b4b0-4fa4-b7fb-7a5085bd9f85 42333-101 HUMAN OTC DRUG Bay Rum Constanza Isopropyl Alcohol LIQUID TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333A Laboratorios Dr. Collado, C x A. ISOPROPYL ALCOHOL 30 mg/30mL 42338-001_2db50852-0050-42e6-9057-419ed56f4b88 42338-001 HUMAN OTC DRUG EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20120106 OTC MONOGRAPH FINAL part352 Extrashade a Sub of Versitile Group AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL 42339-001_56e89f34-fabf-45a4-ae2c-4c264dfb84cd 42339-001 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20120218 OTC MONOGRAPH FINAL part344 Shandong Haiyan Medical Manufacture Co., Ltd. ISOPROPYL ALCOHOL .7 mL/1 42339-002_648cc00b-69b9-45d9-8933-e0d0892de476 42339-002 HUMAN OTC DRUG Povidone-Iodine Pad Povidone-Iodine SWAB TOPICAL 20120218 OTC MONOGRAPH FINAL part333C Shandong Haiyan Medical Manufacture Co., Ltd. POVIDONE-IODINE 9.43 g/100g 42346-100_0ed91856-1390-4933-8827-a1acfa15b6a8 42346-100 HUMAN OTC DRUG Frankincense and Myrrh Cold and Flu Prevention Eucalyptus Globulus, Myrrha, Olibanum, Romarinus Officinalis OIL TOPICAL 20091106 UNAPPROVED HOMEOPATHIC Wise Consumer Products EUCALYPTUS GLOBULUS LEAF; FRANKINCENSE; MYRRH; ROSEMARY 2; 2; 2; 2 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 42346-200_65b4c19a-08f0-40e0-b1ff-b33dfc8ef24c 42346-200 HUMAN OTC DRUG Frankincense and Myrrh Sinus Eucalyptus Globulus, Geranium Maculatum, Myrrha, Olibanum (Frankincense), Romarinus Officinalis OIL TOPICAL 20091106 UNAPPROVED HOMEOPATHIC Wise Consumer Products EUCALYPTUS GLOBULUS LEAF; FRANKINCENSE; GERANIUM MACULATUM ROOT; MYRRH; ROSMARINUS OFFICINALIS FLOWERING TOP 2; 2; 2; 2; 2 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 42346-300_440b0b8c-1940-4231-ba12-15b087d8cde4 42346-300 HUMAN OTC DRUG Frankincense and Myrrh Neuropathy Aconitum Napellus 3X, Bryonia Alba 2X, Hypericum 3X OIL TOPICAL 20091207 20160701 UNAPPROVED HOMEOPATHIC Wise Consumer Products ACONITUM NAPELLUS; BRYONIA ALBA ROOT; ST. JOHN'S WORT 3; 2; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 42346-301_3c2bcec9-53c9-4c8c-a31c-1dcef7acce76 42346-301 HUMAN OTC DRUG Frankincense and Myrrh Neuropathy Aconitum Napellus, Bryonia Alba, Hypericum Perforatum OIL TOPICAL 20130611 UNAPPROVED HOMEOPATHIC Wise Consumer Products ACONITUM NAPELLUS; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM 3; 3; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 42346-400_32728e05-7e3f-4926-a853-746c79cac744 42346-400 HUMAN OTC DRUG Frankincense and Myrrh Fibromyalgia Aconitum Napellus, Bryonia Alba, Geranium Maculatum, Hypericum OIL TOPICAL 20091201 UNAPPROVED HOMEOPATHIC Wise Consumer Products ACONITUM NAPELLUS; BRYONIA ALBA ROOT; GERANIUM MACULATUM ROOT; ST. JOHN'S WORT 3; 2; 2; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 42346-500_053f478e-4b46-4e5c-95c7-89fcb2339e04 42346-500 HUMAN OTC DRUG Frankincense and Myrrh Sciatica Aconitum napellus, Bryonia alba, Hypericum perforatum OIL TOPICAL 20130402 UNAPPROVED HOMEOPATHIC Wise Consumer Products Co. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM 3; 3; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 42346-600_2016927e-7dad-4bc6-a75e-7878faefcbc9 42346-600 HUMAN OTC DRUG Frankincense and Myrrh Carpal Tunnel Aconitum napellus, Bryonia alba, Hypericum perforatum OIL TOPICAL 20130402 UNAPPROVED HOMEOPATHIC Wise Consumer Products ACONITUM NAPELLUS; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM 3; 3; 3 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL 42346-700_6e998214-b059-408b-895c-00876d3aeb3f 42346-700 HUMAN OTC DRUG Frankincense and Myrrh Neck Shoulder and Knee Aconitum napellus, Bryonia alba, Hypericum perforatum OIL TOPICAL 20130402 UNAPPROVED HOMEOPATHIC Wise Consumer Products Co. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM 3; 3; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 42352-1001_661500e3-6f71-48aa-b7c5-fcc13c8a2bdb 42352-1001 HUMAN OTC DRUG Solmeet Denti doctor Rosin POWDER, DENTIFRICE DENTAL 20101211 UNAPPROVED DRUG OTHER Solbin Co., Ltd ROSIN .332 g/g 42352-2001_d7b41c14-85d9-46b8-aca5-1db9f6e97486 42352-2001 HUMAN OTC DRUG Solmeet denti doctor calcium carbonate PASTE, DENTIFRICE DENTAL 20101215 UNAPPROVED DRUG OTHER Solbin Co., Ltd ALCLOXA; AMINOCAPROIC ACID; CALCIUM CARBONATE; DIBASIC CALCIUM PHOSPHATE DIHYDRATE .05; .05; 15.85; .6 g/100g; g/100g; g/100g; g/100g 42352-3001_21e10174-1084-489a-ab25-028423e10ae4 42352-3001 HUMAN OTC DRUG Solmeet calcium carbonate PASTE, DENTIFRICE DENTAL 20101215 UNAPPROVED DRUG OTHER Solbin Co., Ltd ALCLOXA; AMINOCAPROIC ACID; CALCIUM CARBONATE; DIBASIC CALCIUM PHOSPHATE DIHYDRATE .05; .05; 15.85; .6 g/100g; g/100g; g/100g; g/100g 42352-7001_c0412d16-9431-41bd-88af-25623de1e551 42352-7001 HUMAN OTC DRUG Solmeet calcium carbonate PASTE, DENTIFRICE DENTAL 20101215 UNAPPROVED DRUG OTHER Solbin Co., Ltd ALCLOXA; AMINOCAPROIC ACID; CALCIUM CARBONATE; DIBASIC CALCIUM PHOSPHATE DIHYDRATE .05; .05; 15.85; .6 g/100g; g/100g; g/100g; g/100g 42352-8001_c51c4c2a-54e2-4b21-8a00-81dc63d15bca 42352-8001 HUMAN OTC DRUG Solmeet denti doctor calcium carbonate PASTE, DENTIFRICE DENTAL 20101215 UNAPPROVED DRUG OTHER Solbin Co., Ltd ALCLOXA; AMINOCAPROIC ACID; CALCIUM CARBONATE; DIBASIC CALCIUM PHOSPHATE DIHYDRATE .05; .05; 15.85; .6 g/100g; g/100g; g/100g; g/100g 42354-7482_d621b997-3f9f-40b4-a259-788fc0cfe38e 42354-7482 HUMAN OTC DRUG American Red Cross First Aid Kit ALCOHOL, BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ALCOHOL KIT 20120117 OTC MONOGRAPH NOT FINAL part333A Tomy International 42357-001_7a1634c5-6e0f-4ed0-adca-467963541107 42357-001 HUMAN OTC DRUG MyntSmile DIAMYNT SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20120310 OTC MONOGRAPH FINAL part355 LMKAO LLC SODIUM MONOFLUOROPHOSPHATE .83 g/100g 42361-005_7ea19ccb-9be8-4612-b148-3973c749571a 42361-005 HUMAN OTC DRUG The Cover Classic Pro Foundation SPF 24 No. 2 Titanium Dioxide, Octinoxate CREAM TOPICAL 20111220 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .11; 3.0183 g/11g; g/11g 42361-006_7ea19ccb-9be8-4612-b148-3973c749571a 42361-006 HUMAN OTC DRUG The Cover Classic Pro Foundation SPF 24 No. 3 Titanium Dioxide, Octinoxate CREAM TOPICAL 20111220 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .11; 3.011 g/11g; g/11g 42361-007_7ea19ccb-9be8-4612-b148-3973c749571a 42361-007 HUMAN OTC DRUG The Cover Classic Pro Foundation SPF 24 No. 4 Titanium Dioxide, Octinoxate CREAM TOPICAL 20111220 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .11; 3.0003 g/11g; g/11g 42361-008_7ea19ccb-9be8-4612-b148-3973c749571a 42361-008 HUMAN OTC DRUG The Cover Classic Pro Foundation SPF 24 No. 5 Titanium Dioxide, Octinoxate CREAM TOPICAL 20111220 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .11; 3.0183 g/11g; g/11g 42361-009_b6a808cf-1553-42c9-9d6e-e3ed77fa5b2e 42361-009 HUMAN OTC DRUG The Cover Classic Soft Foundation SPF 24 No. O2 Titanium Dioxide, Octinoxate CREAM TOPICAL 20111220 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .088; 2.8826 g/11g; g/11g 42361-010_b6a808cf-1553-42c9-9d6e-e3ed77fa5b2e 42361-010 HUMAN OTC DRUG The Cover Classic Soft Foundation SPF 24 No. O3 Titanium Dioxide, Octinoxate CREAM TOPICAL 20111220 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .088; 2.8826 g/11g; g/11g 42361-011_b6a808cf-1553-42c9-9d6e-e3ed77fa5b2e 42361-011 HUMAN OTC DRUG The Cover Classic Soft Foundation SPF 24, No. N2 Titanium Dioxide, Octinoxate CREAM TOPICAL 20111220 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .088; 2.8826 g/11g; g/11g 42361-012_b6a808cf-1553-42c9-9d6e-e3ed77fa5b2e 42361-012 HUMAN OTC DRUG The Cover Classic Foundation SPF 24, No. N3 Titanium Dioxide, Octinoxate CREAM TOPICAL 20111220 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .088; 2.8826 g/11g; g/11g 42361-013_b6a808cf-1553-42c9-9d6e-e3ed77fa5b2e 42361-013 HUMAN OTC DRUG The Cover Classic Foundation SPF 24, No. O4 Titanium Dioxide, Octinoxate CREAM TOPICAL 20111220 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .088; 2.8826 g/11g; g/11g 42361-014_b7027f48-29d7-47fa-9ee6-3e91b23fc4c8 42361-014 HUMAN OTC DRUG a.c. care Bees Sun Protection Octinoxate, Bemotrizinol, Zinc Oxide, Amiloxate, Titanium Dioxide CREAM TOPICAL 20140820 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm Co., Ltd. AMILOXATE; BEMOTRIZINOL; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.4; 2.1; 5.25; .791; 1.75 g/70g; g/70g; g/70g; g/70g; g/70g 42361-015_5e6a0498-2a47-417a-84d2-117409254b42 42361-015 HUMAN OTC DRUG a.c.care Bees Shield B.B Cream SPF 35 Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140811 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4.55; 2.205; .98 g/50g; g/50g; g/50g 42361-022_71151708-90ee-4627-9b7a-192bf1d17227 42361-022 HUMAN OTC DRUG The Cover Classic Soft Foundation SPF 24, No. O2 Titanium Dioxide, Octinoxate CREAM TOPICAL 20140606 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .088; 2.88265 g/11g; g/11g 42361-025_357e0903-764f-4688-961c-6135f73bb54c 42361-025 HUMAN OTC DRUG The Cover Classic Soft Foundation SPF 24, No. N2 Titanium Dioxide, Octinoxate CREAM TOPICAL 20140606 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .088; 2.88265 g/11g; g/11g 42361-027_c2c20f25-08e0-4727-8932-fdf5565a6d48 42361-027 HUMAN OTC DRUG Impact Fix Essence Make Up Base SPF 10, No. 1 Titanium Dioxide, Octinoxate CREAM TOPICAL 20140606 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .8; 1.2 g/40g; g/40g 42361-029_f60be51e-f2af-42f7-877b-1d72a126acd9 42361-029 HUMAN OTC DRUG Impact Fix Pure Essence Foundation SPF 20, No. 23 Titanium Dioxide, Octinoxate CREAM TOPICAL 20140609 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .8; 3.9984 g/40g; g/40g 42361-030_2cd20d31-6a8f-44a1-bfd4-f205202f62a0 42361-030 HUMAN OTC DRUG Impact Fix Pure Essence Foundation SPF 20, No. 35 Titanium Dioxide, Octinoxate CREAM TOPICAL 20140609 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .8; 3.9984 g/40g; g/40g 42361-032_41096742-d5de-43ea-a97a-3308592c349b 42361-032 HUMAN OTC DRUG Impact Fix Prism Two Way Cake SPF 24, No. 23 Titanium Dioxide, Zinc Oxide, Octinoxate POWDER TOPICAL 20140609 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .196; .9604; .5488 g/14g; g/14g; g/14g 42361-033_97462253-d2a8-41b4-a7f5-c0fa48c767bc 42361-033 HUMAN OTC DRUG Impact Fix Prism Two Way Cake SPF 24, No. 33 Titanium Dioxide, Zinc Oxide, Octinoxate POWDER TOPICAL 20140609 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .196; .9604; .5488 g/14g; g/14g; g/14g 42361-035_32af8e52-8220-409c-bb83-7232d3fd5fcc 42361-035 HUMAN OTC DRUG Re20 Light Wrinkle BB Cream SPF 50 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140606 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 5.952; 3.783 g/60g; g/60g 42361-036_3ae15396-e51c-4576-b576-8cf2001684bf 42361-036 HUMAN OTC DRUG Re20 Ultra Sun Defense Special Set SPF 44 Octinoxate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20140606 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4.2; 1.44; 1.764 g/60g; g/60g; g/60g 42361-038_22b97b0d-d0f0-4ce7-af97-650ac8797409 42361-038 HUMAN OTC DRUG Hansai Beestox Trial Kit Set Beestox Sun Cream Octinoxate, Bemotrizinol, Zinc Oxide, Amiloxate, Titanium Dioxide CREAM TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. AMILOXATE; BEMOTRIZINOL; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .1; .15; .375; .057; .125 g/5g; g/5g; g/5g; g/5g; g/5g 42361-039_34ba3d2c-4333-4a74-8302-3d0f24a5a3c4 42361-039 HUMAN OTC DRUG Hansai Beestox Sun Cream SPF 50 Octinoxate, Bemotrizinol, Zinc Oxide, Amiloxate, Titanium Dioxide CREAM TOPICAL 20140606 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. AMILOXATE; BEMOTRIZINOL; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; 1.35; 3.375; .51381; 1.12646 g/45g; g/45g; g/45g; g/45g; g/45g 42361-041_1cc079b3-8bc2-4774-be64-03b58a25b00e 42361-041 HUMAN OTC DRUG Mo-Tech PYRITHIONE ZINC SHAMPOO TOPICAL 20140820 OTC MONOGRAPH FINAL part358H Dong Sung Pharm Co., Ltd. PYRITHIONE ZINC 2.52 mg/240mL 42361-042_47534df7-9920-4b32-a67c-613df66562ea 42361-042 HUMAN OTC DRUG a.c.care Bees Foam Cleanser Triclocarban CREAM TOPICAL 20141123 OTC MONOGRAPH NOT FINAL part333E Dong Sung Pharm Co., Ltd. TRICLOCARBAN 459 mg/150mL 42361-042_befdb187-b282-47ed-b323-0d968693f6e4 42361-042 HUMAN OTC DRUG a.c.care Bees Foam Cleanser Triclocarban CREAM TOPICAL 20140923 OTC MONOGRAPH NOT FINAL part333E Dong Sung Pharm Co., Ltd. TRICLOCARBAN 459 mg/150mL 42361-043_ec872242-5765-49f5-8731-78660fab379b 42361-043 HUMAN OTC DRUG YouGreen F Urea OINTMENT TOPICAL 20140820 UNAPPROVED DRUG OTHER Dong Sung Pharm Co., Ltd. UREA 7.5 g/30g 42361-045_03aea1d9-efd2-450d-a45d-dacf2ae900a1 42361-045 HUMAN OTC DRUG a.c.care Bees Foam Cleanser Troubled Skin Care 2 pcs Set Triclocarban CREAM TOPICAL 20141204 OTC MONOGRAPH NOT FINAL part333E Dong Sung Pharm Co., Ltd. TRICLOCARBAN 153 mg/50mL 42361-051_621299b1-3d71-4adc-84ff-b8e6698cb534 42361-051 HUMAN OTC DRUG Sun Barrier UV Milk Broad Spectrum SPF 50 Titanium Dioxide, Octinoxate, Zinc Oxide, Octisalate, Bemotrizinol LOTION TOPICAL 20141202 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. BEMOTRIZINOL; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 1.125; 5.625; 3.375; 6.3; 4.23 g/75g; g/75g; g/75g; g/75g; g/75g 42361-052_08914284-7304-488a-b548-5188be33ef7d 42361-052 HUMAN OTC DRUG Sun Barrier UV Shaking Broad Spectrum SPF 50 Titanium Dioxide, Octinoxate, Zinc Oxide, Octisalate, Bemotrizinol LOTION TOPICAL 20141202 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. BEMOTRIZINOL; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 1.125; 5.625; 3.375; 6.3; 4.23 g/75g; g/75g; g/75g; g/75g; g/75g 42361-053_70771f52-0869-44af-a620-c1cda78a0dfa 42361-053 HUMAN OTC DRUG Sun Barrier UV Protector Broad Spectrum SPF 50 Titanium Dioxide, Octinoxate, Zinc Oxide, Octisalate, Bemotrizinol LOTION TOPICAL 20141202 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd BEMOTRIZINOL; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; 5.25; 3.15; 5.88; 3.948 g/70g; g/70g; g/70g; g/70g; g/70g 42361-054_70cf52fe-6d55-4697-965a-5fe160b1c368 42361-054 HUMAN OTC DRUG Sun Barrier UV Aqua Sun Broad Spectrum SPF 50 Octinoxate, Titanium Dioxide, Octisalate, Bemotrizinol SPRAY TOPICAL 20141202 OTC MONOGRAPH NOT FINAL part352 Dong Sung Pharm. Co., Ltd. BEMOTRIZINOL; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 4.4; 7.575; 5.05; 31.302 g/100mL; g/100mL; g/100mL; g/100mL 42361-401_447050fc-c7b6-4609-bada-0e4127a45670 42361-401 HUMAN OTC DRUG Red Chilli Plaster Capsicum PATCH TOPICAL 20141124 OTC MONOGRAPH NOT FINAL part348 Dong Sung Pharm. Co., Ltd. CAPSICUM 105 mg/1 42364-0003_8ae5e4d7-1e73-01f6-87c6-9b43ac686778 42364-0003 HUMAN OTC DRUG Anti Monkey Butt Diaper Rash Zinc Oxide and Ferric Oxide Red CREAM TOPICAL 20120418 OTC MONOGRAPH FINAL part352 DSE Healthcare Solutions, LLC. FERRIC OXIDE RED; ZINC OXIDE .001; .139 g/g; g/g 42364-0013_a52cbea7-84bb-908a-1c14-1b1a88004f58 42364-0013 HUMAN OTC DRUG Baby Anti Monkey Butt Diaper Rash Ferric Oxide Red and Zinc Oxide POWDER TOPICAL 20120418 OTC MONOGRAPH FINAL part352 DSE Healthcare Solutions, LLC. FERRIC OXIDE RED; ZINC OXIDE .004; .076 g/g; g/g 42364-4501_be9671af-3614-d70e-8639-87f8dc8e3b44 42364-4501 HUMAN OTC DRUG Cystex Plus Methenamine, Sodium Salicylate TABLET ORAL 20120401 UNAPPROVED DRUG OTHER DSE Healthcare Solutions, LLC METHENAMINE; SODIUM SALICYLATE 162; 162.5 mg/1; mg/1 42367-110_a9cea5dd-d282-4ba2-ac44-d8b01eceffb1 42367-110 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Delayed-Release Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20140715 ANDA ANDA200540 Eagle Pharmaceuticals, Inc. DICLOFENAC SODIUM; MISOPROSTOL 50; .2 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 42367-111_a9cea5dd-d282-4ba2-ac44-d8b01eceffb1 42367-111 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Delayed-Release Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20140715 ANDA ANDA200540 Eagle Pharmaceuticals, Inc. DICLOFENAC SODIUM; MISOPROSTOL 75; .2 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 42367-202_1d3314d7-c107-4183-bdb2-9672f23a5b99 42367-202 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION INTRAVENOUS 20110906 NDA NDA022434 Eagle Pharmaceuticals, Inc. ARGATROBAN 1 mg/mL 42367-203_37fa84e8-f18e-44cb-a55f-8bcd3269243a 42367-203 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION INTRAVENOUS 20110906 NDA NDA022434 Eagle Pharmaceuticals, Inc. ARGATROBAN 1 mg/mL 42367-540_6ca95e99-3bf4-43c7-bb67-1a1d87edf158 42367-540 HUMAN PRESCRIPTION DRUG RYANODEX dantrolene sodium dantrolene sodium INJECTION, SUSPENSION INTRAVENOUS 20140723 NDA NDA205579 Eagle Pharmaceuticals, Inc. DANTROLENE SODIUM 250 mg/5mL Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] 42377-001_5a71fe24-8b62-4052-a994-fb7bf9f91e2c 42377-001 HUMAN OTC DRUG Next 1 Anti-Bacterial Sport TRICLOCARBAN SOAP TOPICAL 20130606 OTC MONOGRAPH NOT FINAL part333E HADA International S.A TRICLOCARBAN 1.5 g/100g 42387-123_9115b517-7163-4b7a-b471-94890e82ec4c 42387-123 HUMAN OTC DRUG GN Kids Eczema Oatmeal CREAM TOPICAL 20120424 OTC MONOGRAPH FINAL part347 Grahams Natural Alternatives Pty Ltd OATMEAL 25 mg/g 42388-011_0c07e5b3-aece-49e8-bbb4-84ee29f58661 42388-011 HUMAN PRESCRIPTION DRUG COMETRIQ cabozantinib KIT 20121129 NDA NDA203756 Exelixis, Inc. 42388-012_0c07e5b3-aece-49e8-bbb4-84ee29f58661 42388-012 HUMAN PRESCRIPTION DRUG COMETRIQ cabozantinib KIT 20121129 NDA NDA203756 Exelixis, Inc. 42388-013_0c07e5b3-aece-49e8-bbb4-84ee29f58661 42388-013 HUMAN PRESCRIPTION DRUG COMETRIQ cabozantinib CAPSULE ORAL 20121129 NDA NDA203756 Exelixis, Inc. CABOZANTINIB S-MALATE 20 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 42388-014_0c07e5b3-aece-49e8-bbb4-84ee29f58661 42388-014 HUMAN PRESCRIPTION DRUG COMETRIQ cabozantinib CAPSULE ORAL 20121129 NDA NDA203756 Exelixis, Inc. CABOZANTINIB S-MALATE 20 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 42389-001_bf8fe74e-c2aa-4752-94a3-e1e0e9c0e82c 42389-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20071201 UNAPPROVED MEDICAL GAS CR Pharmacy Services, Inc. OXYGEN 990 mL/L 42392-001_ad98495f-250c-4926-9c35-8ac88c7d2686 42392-001 HUMAN PRESCRIPTION DRUG Nitrogen, Refrigerated NITROGEN LIQUID RESPIRATORY (INHALATION) 20120201 UNAPPROVED MEDICAL GAS Schwarcz Liquid Nitrogen Service, Inc. NITROGEN 1 L/L 42403-010_479f2162-db77-419d-89ea-2cf85c3994de 42403-010 HUMAN OTC DRUG US Favorite Cold Pain Relieving MENTHOL LIQUID TOPICAL 20120104 OTC MONOGRAPH FINAL part348 Ken Mable MENTHOL 25 g/100g 42403-020_8fe28aea-6def-446c-b5bd-b2bcd70f36a1 42403-020 HUMAN OTC DRUG US Favorite Hot Pain Relieving METHYL SALICYLATE LIQUID TOPICAL 20120104 OTC MONOGRAPH FINAL part348 Ken Mable METHYL SALICYLATE 10 g/100g 42406-001_ba94c153-532a-4396-af52-76ff9e3e31ae 42406-001 HUMAN OTC DRUG Fresh Sugar Passion Tinted Lip Treatment SPF 15 OCTINOXATE, AVOBENZONE STICK TOPICAL 20120207 OTC MONOGRAPH FINAL part352 Fresh, Inc. AVOBENZONE; OCTINOXATE 2; 7.49 g/100g; g/100g 42406-002_5b881b08-20a6-4a8b-b2eb-c226a07fa035 42406-002 HUMAN OTC DRUG Fresh Sugar Coral Tinted Lip Treatment SPF 15 OCTINOXATE, AVOBENZONE STICK TOPICAL 20120208 OTC MONOGRAPH FINAL part352 Fresh, Inc. AVOBENZONE; OCTINOXATE 2; 7.49 g/100g; g/100g 42406-003_38e08fdb-b120-4d81-8b38-e9ef77359486 42406-003 HUMAN OTC DRUG Fresh Sugar Berry Tinted Lip Treatment SPF 15 AVOBENZONE, OCTINOXATE STICK TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 Fresh, Inc. AVOBENZONE; OCTINOXATE 2; 7.49 g/100g; g/100g 42406-004_e513adbe-249e-4e81-b3ef-02d676029ec2 42406-004 HUMAN OTC DRUG Fresh Sugar Petal Tinted Lip Treatment SPF 15 AVOBENZONE, OCTINOXATE STICK TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 Fresh, Inc. AVOBENZONE; OCTINOXATE 2; 7.49 g/100g; g/100g 42406-005_bbb7e9f9-71fe-4fd5-a0fb-6b91ff76d978 42406-005 HUMAN OTC DRUG Fresh Sugar Cherry Tinted Lip Treatment SPF 15 AVOBENZONE, OCTINOXATE STICK TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 Fresh, Inc. AVOBENZONE; OCTINOXATE 2; 7.49 g/100g; g/100g 42406-006_cad95775-3d92-4438-871e-7d18d0278b9b 42406-006 HUMAN OTC DRUG Fresh Sugar Tulip Tinted Lip Treatment Sunscreen SPF 15 AVOBENZONE, OCTINOXATE STICK TOPICAL 20140109 OTC MONOGRAPH NOT FINAL part352 Fresh, Inc. AVOBENZONE; OCTINOXATE 2; 7.49 g/100g; g/100g 42406-007_98d17614-bac8-46c2-a1f3-dd796f8f96c7 42406-007 HUMAN OTC DRUG Fresh Peony Brightening UV Shield Sunscreen SPF 50 Plus OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20140109 OTC MONOGRAPH NOT FINAL part352 Fresh, Inc. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 74.9; 20; 88.8 mg/mL; mg/mL; mg/mL 42406-008_e36b75c9-ceba-4eac-b387-1382025d1e9d 42406-008 HUMAN OTC DRUG Fresh Sugar Ruby Tinted Lip Treatment Sunscreen SPF 15 AVOBENZONE, OCTINOXATE STICK TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Fresh, Inc. AVOBENZONE; OCTINOXATE 20; 7.49 g/100g; g/100g 42406-009_a8258de1-c231-494f-89d2-d515c3f15358 42406-009 HUMAN OTC DRUG Fresh Black Tea Age-Delay Broad Spectrum Sunscreen SPF 20 AVOBENZONE, OCTINOXATE, OXYBENZONE LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Fresh, Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE 18; 74.9; 24 mg/mL; mg/mL; mg/mL 42406-100_5562dc69-efbb-478b-8855-d3d164107bef 42406-100 HUMAN OTC DRUG Fresh Soy Moisturizing SPF 20 OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE EMULSION TOPICAL 20120207 OTC MONOGRAPH FINAL part352 Fresh, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.49; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 42411-010_a41516d7-1490-46c5-82bc-297c21388258 42411-010 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Air Liquide America Specialty Gases LLC OXYGEN 99 L/100L 42411-011_423f407a-ae18-437a-9740-996c357de13f 42411-011 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205712 Air Liquide America Specialty Gases LLC OXYGEN 99 L/100L 42411-012_19223e6b-a790-41e8-9020-ba390fc0a30d 42411-012 HUMAN PRESCRIPTION DRUG Oxygen Oxygen LIQUID RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Air Liquide America Specialty Gases LLC OXYGEN 99 L/100L 42411-020_58cb2478-57ca-4361-8395-f405d7edac0d 42411-020 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205713 Air Liquide America Specialty Gases LLC NITROGEN 99 L/100L 42411-021_f12fda4b-5c29-40b1-b0e3-4eb27afe51d4 42411-021 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205713 Air Liquide America Specialty Gases LLC NITROGEN 99 L/100L 42411-022_7d29f38b-25e8-4392-a24f-5139a72b8ed6 42411-022 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205713 Air Liquide America Specialty Gases LLC NITROGEN 99 L/100L 42411-040_5779524a-129b-4b58-bb79-6dff780b1fbc 42411-040 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205704 Air Liquide America Specialty Gases LLC NITROUS OXIDE 99 L/100L 42411-041_17030ad0-2311-4a1a-bc8b-88dd160588b1 42411-041 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205704 Air Liquide America Specialty Gases LLC NITROUS OXIDE 99 L/100L 42411-043_96a4a2a2-5aa0-4af5-81ae-e8a3eee5d043 42411-043 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205704 Air Liquide America Specialty Gases LLC NITROUS OXIDE 99 L/100L 42411-050_32c50f65-b9b5-4b68-9db2-3509b655b88a 42411-050 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205846 Air Liquide America Specialty Gases LLC CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 42411-051_2e1f818b-652d-4f25-af6f-58b634ce306b 42411-051 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205846 Air Liquide America Specialty Gases LLC CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 42411-060_e7256700-d66d-4e48-a4e0-1bc67bb1303a 42411-060 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mixture Carbon Dioxide Oxygen Mixture GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Air Liquide America Specialty Gases LLC CARBON DIOXIDE; OXYGEN 5; 95 L/100L; L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 42411-080_6093f87d-b589-4cc2-ae15-b1a4852a16c9 42411-080 HUMAN PRESCRIPTION DRUG AIR AIR GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205711 Air Liquide America Specialty Gases LLC AIR 99 L/100L 42411-100_2687ab9f-0c4e-4c13-95f4-819644c6eb06 42411-100 HUMAN PRESCRIPTION DRUG EZ-Ox EZ-Ox GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205737 Air Liquide America Specialty Gases LLC OXYGEN 99 L/100L 42411-101_0c1de55a-40c5-4f5c-9fdc-3069dd6a9e09 42411-101 HUMAN PRESCRIPTION DRUG EZ-Ox Plus EZ-Ox Plus GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205737 Air Liquide America Specialty Gases LLC OXYGEN 99 L/100L 42416-0021_3bd6abd3-df25-4022-ad4e-a610b77c897d 42416-0021 HUMAN OTC DRUG Formula 21 Diaper Rash ZINC OXIDE CREAM TOPICAL 20120126 OTC MONOGRAPH FINAL part347 DRA Bello Products, Inc. ZINC OXIDE 25 mL/100mL 42421-034_7d1fb191-0462-411b-8494-48e15637b96a 42421-034 HUMAN OTC DRUG Ultimate Daily Face Wash Salicylic Acid CREAM TOPICAL 20140110 OTC MONOGRAPH FINAL part333D Emilia Personal Care Inc. SALICYLIC ACID 2 g/100mL 42421-115_263bf96a-ddb9-45cc-8c80-8f69843d55c5 42421-115 HUMAN OTC DRUG H-E-B Dead Sea Organics Protect and Perfect Day Broad Spectrum SPF15 Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20140110 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL 42421-226_730659cc-f4b6-49a0-9459-42652723fd1f 42421-226 HUMAN OTC DRUG Safe Harbor - Natural Anti-Aging Sunscreen Broad Spectrum SPF30 Sunscreen Sensitive Skin Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20140105 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. TITANIUM DIOXIDE; ZINC OXIDE 11.4; 3 g/100mL; g/100mL 42421-229_fc2c22fc-39f2-4d23-a5ce-2b169cfb802c 42421-229 HUMAN OTC DRUG Oil Free Blackhead Removal Scrub Salicylic Acid CREAM TOPICAL 20131205 OTC MONOGRAPH FINAL part333D Emilia Personal Care Inc. SALICYLIC ACID 2 g/100g 42421-232_80423356-a7ef-4f54-8347-6f7f2c37956f 42421-232 HUMAN OTC DRUG Illuminating Daily Moisturizer Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20140110 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 g/100mL; g/100mL; g/100mL 42421-290_16dbf1bd-60d5-4383-bf31-3905ff9095ef 42421-290 HUMAN OTC DRUG Seacret Active Clear Facial Wash Salicylic Acid GEL TOPICAL 20141017 OTC MONOGRAPH FINAL part333D Emilia Personal Care Inc. SALICYLIC ACID 2 g/100mL 42421-326_71f476f9-c532-43a3-847b-a4bd3de519c8 42421-326 HUMAN OTC DRUG Daily Facial Moisturizer Broad Spectrum SPF15 Sunscreen Avobenzone, Octocrylene CREAM TOPICAL 20140110 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. AVOBENZONE; OCTOCRYLENE 3; 10 g/100mL; g/100mL 42421-418_9e2fb9bb-8a79-4675-84df-fd5990f7db1d 42421-418 HUMAN OTC DRUG Safe Harbor - Natural Sunscreen Face and Neck Cream Broad Spectrum SPF40 Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140105 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. TITANIUM DIOXIDE; ZINC OXIDE 12.35; 3.5 g/100mL; g/100mL 42421-419_fbd287cf-a557-42ab-a530-9aee849c068d 42421-419 HUMAN OTC DRUG Earth and Vine BB Broad Spectrum SPF 15 Sunscreen Octinoxate and Titanium Dioxide CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. OCTINOXATE; TITANIUM DIOXIDE 4; 2.1 g/100g; g/100g 42421-618_90d8f83c-012e-42fe-85c5-2e1fe4453f43 42421-618 HUMAN OTC DRUG H-E-B Skin Corrective Innovative Skin Perfector BB Broad Spectrum SPF15 Sunscreen Medium/Deep Titanium Dioxide, Octinoxate CREAM TOPICAL 20140110 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. OCTINOXATE; TITANIUM DIOXIDE 4; 2.1 g/100mL; g/100mL 42421-641_3a3faea7-8862-4d4b-82a0-e86e29f1dc12 42421-641 HUMAN OTC DRUG Innovative Skin Perfector BB Broad Spectrum SPF15 Sunscreen (Light/Medium) Octinoxate and Titanium Dioxide CREAM TOPICAL 20140110 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. OCTINOXATE; TITANIUM DIOXIDE 4; 2.1 g/100g; g/100g 42421-692_d1d1084d-1591-4273-82a1-6b6c23b62a9f 42421-692 HUMAN OTC DRUG Desert Fusion Nutritious Olive Leaf Daily Defense Broad Spectrum SPF 15 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 4 g/100g; g/100g; g/100g; g/100g 42421-716_38534f6c-f0b6-40fe-a1d5-b19a6f529785 42421-716 HUMAN OTC DRUG Evervescence Daily Facial Moisturizer Broad Spectrum SPF15 Sunscreen Avobenzone, Octocrylene CREAM TOPICAL 20140110 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. AVOBENZONE; OCTOCRYLENE 3; 10 g/100mL; g/100mL 42421-775_58a5201f-1145-4068-bf72-9d3e6ccc4add 42421-775 HUMAN OTC DRUG Oil-Free Acne Wash Foaming Scrub Salicylic Acid GEL TOPICAL 20131205 OTC MONOGRAPH FINAL part333D Emilia Personal Care Inc. SALICYLIC ACID 2 g/100mL 42421-814_974bb69c-e76e-49a6-b754-ad337250ac2f 42421-814 HUMAN OTC DRUG H-E-B Skin Corrective Innovative Skin Perfector BB Broad Spectrum SPF15 Sunscreen Light/Medium Titanium Dioxide, Octinoxate CREAM TOPICAL 20140110 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. OCTINOXATE; TITANIUM DIOXIDE 4; 2.1 g/100mL; g/100mL 42421-815_51837bfc-3ccb-457f-a5f2-db8532ee148d 42421-815 HUMAN OTC DRUG Advanced Firming and Anti-Wrinkle Moisturizer Day Broad Spectrum SPF18 Sunscreen Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20140110 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 5 g/100g; g/100g; g/100g 42421-821_50576262-1161-4f5b-9532-81bf1954256a 42421-821 HUMAN OTC DRUG Safe Harbor - Natural Sunscreen - Baby and Kids SPF50 Broad Spectrum Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140105 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. TITANIUM DIOXIDE; ZINC OXIDE 11.4; 4 g/100mL; g/100mL 42421-926_e615176c-e829-4f5c-8d46-0fb405e9c1e2 42421-926 HUMAN OTC DRUG Safe Harbor - Natural - Sensitive SPF50 Broad Spectrum Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20140105 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. TITANIUM DIOXIDE; ZINC OXIDE 10.4; 4 g/100mL; g/100mL 42423-270_80c3b9df-d1ca-459c-bdb9-34fa98e689bd 42423-270 HUMAN OTC DRUG EasyTouch Alcohol Prep Pads Nonsterile Isopropyl Alcohol SWAB TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part333A MHC Medical Products, LLC ISOPROPYL ALCOHOL 70 mL/100mL 42423-271_e73638c3-2de7-4a63-800f-46e933e73273 42423-271 HUMAN OTC DRUG EasyTouch Alcohol Prep Pads Sterile Isopropyl Alcohol SWAB TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part333A MHC Medical Products, LLC ISOPROPYL ALCOHOL 70 mL/100mL 42427-002_ea1cee80-14a9-11e3-8ffd-0800200c9a66 42427-002 HUMAN PRESCRIPTION DRUG VALCHLOR mechlorethamine hydrochloride GEL TOPICAL 20131021 NDA NDA202317 Ceptaris Therapeutics, Inc. MECHLORETHAMINE .012 g/60g Alkylating Activity [MoA],Alkylating Drug [EPC] 42432-019_d4b79b4b-b867-4e55-a3d8-bd158a3220b4 42432-019 HUMAN OTC DRUG Kiss Fungi-Gone Anti-fungal Treatment Tolnaftate LIQUID TOPICAL 20121023 OTC MONOGRAPH FINAL part333C Kiss Products, Inc. TOLNAFTATE 10 mg/mL 42449-120_53bdbe99-08a4-45a4-b93b-65acd895315a 42449-120 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part333A Aero-Med Ltd ISOPROPYL ALCOHOL 1.4 mL/1 42449-122_982db3cf-63f2-4f0f-8e34-50c3a93a30dd 42449-122 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20120203 OTC MONOGRAPH NOT FINAL part333A Aero-Med Ltd ISOPROPYL ALCOHOL .7 mL/mL 42449-210_5553f6f3-4b9d-4d9e-a683-713b888cc4f9 42449-210 HUMAN OTC DRUG BZK Antiseptic Benzalkonium Chloride SWAB TOPICAL 20120202 OTC MONOGRAPH NOT FINAL part333A Aero-Med Ltd BENZALKONIUM CHLORIDE 1 g/750g 42452-378_d1a4de91-8951-46f1-9e30-842e9aa28002 42452-378 HUMAN OTC DRUG Revalife Topical menthol OINTMENT TOPICAL 20120126 OTC MONOGRAPH NOT FINAL part348 International Nutraceutical Company of America (INCA), LLC MENTHOL 937.5 mg/g 42457-001_7f1b4835-29e7-43a6-892f-db57fcb621ea 42457-001 HUMAN PRESCRIPTION DRUG NutreStore glutamine POWDER, FOR SOLUTION ORAL 20080604 NDA NDA021667 Emmaus Medical, Inc. GLUTAMINE 5 g/1 Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 42468-1001_c8baed93-6ae6-4bcc-b5cc-c812db1cc1ac 42468-1001 HUMAN OTC DRUG JAMU Sexty clove TABLET VAGINAL 20120502 UNAPPROVED DRUG OTHER JMBio Co., Ltd. CLOVE 18 mg/1 42469-1001_757313b9-0479-4e26-ad62-d60264831437 42469-1001 HUMAN OTC DRUG Bone Care ATRACTYLODES LANCEA ROOT TABLET ORAL 20120604 UNAPPROVED DRUG OTHER Evercarepharm Co., Ltd ATRACTYLODES LANCEA ROOT 170 mg/1 42469-2001_e1589433-4355-4d27-a5ff-0bdb7737d73b 42469-2001 HUMAN OTC DRUG Stomint ATRACTYLODES LANCEA ROOT TABLET ORAL 20120606 UNAPPROVED DRUG OTHER Evercarepharm Co., Ltd ATRACTYLODES LANCEA ROOT 70 mg/1 42469-3001_d098171e-4f75-4702-bbec-d6a50bb56c57 42469-3001 HUMAN OTC DRUG Green Body MACLURA TRICUSPIDATA WHOLE TABLET ORAL 20120703 UNAPPROVED DRUG OTHER Evercarepharm Co., Ltd MACLURA TRICUSPIDATA WHOLE 180 mg/1 42472-001_fe5bfddb-4c84-45d1-a48c-8e1d92961fab 42472-001 HUMAN OTC DRUG 24 HOUR ANTIPERSPIRANT NATURAL ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY SPRAY TOPICAL 19791001 OTC MONOGRAPH FINAL part350 ARAMIS INC. ALUMINUM CHLOROHYDREX PROPYLENE GLYCOL 10 mL/100mL 42472-002_dc74ce6c-6e92-429b-846d-df428433dd2c 42472-002 HUMAN OTC DRUG LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20110424 OTC MONOGRAPH NOT FINAL part352 Aramis Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.4; 4; 2.5; 2.2; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 42472-695_57aa4879-7e8d-46bc-a98f-0cb422f0df24 42472-695 HUMAN OTC DRUG 24 HOUR HIGH PERFORMANCE ANTIPERSPIRANT ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 19840401 OTC MONOGRAPH FINAL part350 ARAMIS INC. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.6 mL/100mL 42472-720_c23eb632-a3b9-49ff-b78a-f74c05bfc046 42472-720 HUMAN OTC DRUG ARAMIS LAB SERIES POWER PROTECTOR SPF 50 OCTISALATE, HOMOSALATE, AVOBENZONE, OXYBENZONE LOTION TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 ARAMIS INC AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 5; 5; 3 1/100mL; mL/100mL; mL/100mL; mL/100mL 42472-887_0cc49c82-b0d8-4ae9-8985-028826430374 42472-887 HUMAN OTC DRUG LAB SERIES SKINCARE FOR MEN DAILY MOISTURE DEFENSE BROAD SPECTRUM SPF 15 AVOBENZONE, OCTINOXATE, and OCTISALATE LOTION TOPICAL 20050101 OTC MONOGRAPH NOT FINAL part352 ARAMIS INC. AVOBENZONE; OCTINOXATE; OCTISALATE .0212; .0795; .0318 g/100mL; g/100mL; g/100mL 42475-001_a32c8d04-f634-4714-9525-51cf120ba1da 42475-001 HUMAN OTC DRUG COGHLANS SURVIVAL IN A CAN ISOPROPYL ALCOHOL LIQUID TOPICAL 20120711 OTC MONOGRAPH FINAL part333A Coghlan's Ltd. ISOPROPYL ALCOHOL .7 mL/mL 42479-212_1e50c0d6-debd-4201-bae3-d33a3b646457 42479-212 HUMAN OTC DRUG footlogix Clotrimazole AEROSOL, SPRAY TOPICAL 20100901 OTC MONOGRAPH FINAL part333 KVG Group Inc CLOTRIMAZOLE 1 mL/100mL 42479-213_1640faba-7234-4ef6-90c4-c8e55f860ffc 42479-213 HUMAN OTC DRUG footlogix intensive care diabetic formula Clotrimazole AEROSOL, FOAM TOPICAL 20120615 OTC MONOGRAPH FINAL part333C KVG Group Inc CLOTRIMAZOLE 1 g/100g 42479-214_20ce9225-fb52-4a93-9b9a-3bfa36b17806 42479-214 HUMAN OTC DRUG footlogix moisturizing diabetic formula Dimethicone AEROSOL, FOAM TOPICAL 20120715 OTC MONOGRAPH FINAL part347 KVG Group Inc DIMETHICONE 1 g/100g 42485-003_d95c940a-8f82-4928-8512-188b9f9224f0 42485-003 HUMAN OTC DRUG OC Eight benzoyl peroxide GEL TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part333D Biopelle, Inc. BENZOYL PEROXIDE 7 mg/g 42485-004_b022010d-4624-4cbc-baa7-93f29c5195b8 42485-004 HUMAN OTC DRUG LET ME BE PERFECTLY CLEAR benzoyl peroxide KIT 20110401 OTC MONOGRAPH NOT FINAL part333D Biopelle, Inc. 42485-005_48cda9da-ce2f-42da-9ecd-baf3d8632231 42485-005 HUMAN OTC DRUG Broad Spectrum SPF 30 Up The Anti TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20121114 OTC MONOGRAPH NOT FINAL part352 Biopelle, Inc. TITANIUM DIOXIDE; ZINC OXIDE 32; 60 mg/mL; mg/mL 42485-006_3aca1373-e465-44ff-8379-0366d682e837 42485-006 HUMAN OTC DRUG STOP THE CLOCK BROAD SPECTRUM SPF 50 avobenzone, homosalate, titanium dioxide, zinc oxide CREAM TOPICAL 20090801 OTC MONOGRAPH FINAL part352 Biopelle, Inc. AVOBENZONE; HOMOSALATE; TITANIUM DIOXIDE; ZINC OXIDE 30; 70; 35; 10 mg/mL; mg/mL; mg/mL; mg/mL 42485-007_51498b64-d362-4176-9944-ca4fc00c2953 42485-007 HUMAN OTC DRUG Lasting Results Moisturizer octocrylene, octinoxate, oxybenzone,octisalate, avobenzone LOTION TOPICAL 20120501 OTC MONOGRAPH FINAL part352 Biopelle, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 75; 50; 100; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 42494-119_49b25c44-7408-4693-b0b5-9420c3a07c98 42494-119 HUMAN PRESCRIPTION DRUG Se-Tan DHA Ferrous Fumarate and Polysaccharide Iron CAPSULE, GELATIN COATED ORAL 20091001 UNAPPROVED DRUG OTHER Cameron Pharmaceuticals DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; ICOSAPENT; IRON DEXTRAN; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; SODIUM ASCORBATE 215.12; 15; 1; 53.46; 15; 310.1; 25; 20 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] 42495-170_9caaf4e7-9323-4974-b5e0-e9306d6a1b61 42495-170 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 Westwood Manufacturing HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 42495-556_cd30946c-4a89-4c53-801e-e0d1fc1c10aa 42495-556 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 Westwood Manufacturing GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42497-086_035b63b6-46d4-4c2f-b09f-1baab227bd2f 42497-086 HUMAN OTC DRUG E-2 Cleanser Sanitizer 86 Hand Sanitizer SOAP TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Penco Products, Inc. BENZALKONIUM CHLORIDE 2.5 g/100g 42497-822_7b555ca2-7f7d-4b04-b1e4-f415cbe899c7 42497-822 HUMAN OTC DRUG Antibacterial Skin Cleanser 82 Antibacterial Hand Soap SOAP TOPICAL 20100304 OTC MONOGRAPH NOT FINAL part333 Penco Products, Inc. CHLOROXYLENOL 1 g/100g 42507-002_5c56b3f8-5e88-4e82-a4e3-b828c27e4277 42507-002 HUMAN OTC DRUG enema Saline ENEMA RECTAL 20091228 OTC MONOGRAPH NOT FINAL part334 HyVee Inc SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 42507-004_2c3802c6-f542-4f25-b556-4e7ab1a3e9bc 42507-004 HUMAN OTC DRUG Kids Flouride Rinse Sodium Fluoride RINSE ORAL 20030911 OTC MONOGRAPH FINAL part355 Hy-Vee, Inc SODIUM FLUORIDE .05 kg/100L 42507-005_143191e1-9db7-4011-9ea1-7aa9f5176c41 42507-005 HUMAN OTC DRUG Stool Softener Gentle Relief DOCUSATE SODIUM CAPSULE ORAL 20121215 OTC MONOGRAPH NOT FINAL part334 Hy-Vee DOCUSATE SODIUM 100 mg/1 42507-008_4c6a389f-f336-4150-889e-c7c9066d833a 42507-008 HUMAN OTC DRUG pain relief infants Acetaminophen SUSPENSION/ DROPS ORAL 19921111 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 80 mg/.8mL 42507-010_9f7c8bab-9ab4-434e-95e7-7082a221d9fb 42507-010 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20050523 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 500 mg/1 42507-013_3a60bbfc-e503-419f-b85e-89396823c9ff 42507-013 HUMAN OTC DRUG allergy and congestion relief Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120319 ANDA ANDA076050 HyVee Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 42507-014_fe0f1c64-d695-4f86-a212-a021a1bedbb5 42507-014 HUMAN OTC DRUG cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070924 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 42507-027_dfc502e9-356d-45f5-b744-9e5dbe627f9d 42507-027 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130315 OTC MONOGRAPH NOT FINAL part343 Hy-Vee ASPIRIN 81 mg/1 42507-031_36ce78bf-0113-4999-a420-62130c5eae19 42507-031 HUMAN OTC DRUG day time nighttime cough dextromethorphan HBr, doxylamine succinate KIT 20120830 OTC MONOGRAPH FINAL part341 HyVee Inc 42507-033_95b12a14-21ee-431d-a892-46f8cdca2d7a 42507-033 HUMAN OTC DRUG nighttime sleep aid Doxylamine succinate TABLET ORAL 20141204 ANDA ANDA040167 HyVee Inc DOXYLAMINE SUCCINATE 25 mg/1 42507-041_9f4f5b07-a8cf-4b9a-bb32-b3bba30907aa 42507-041 HUMAN OTC DRUG Nighttime Cold and Flu acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20060605 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 42507-046_6ffffb45-c906-4214-b39c-f68bc3c3737b 42507-046 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET, COATED ORAL 20090817 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 500 mg/1 42507-047_0f551a2c-3752-4bf3-b323-36199b79313e 42507-047 HUMAN OTC DRUG acid reducer maximum strength Ranitidine TABLET ORAL 20080217 ANDA ANDA078653 HyVee Inc RANITIDINE HYDROCHLORIDE 150 mg/1 42507-050_ab494313-9da2-4544-a875-1896ddf466ea 42507-050 HUMAN OTC DRUG ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090302 ANDA ANDA079113 HyVee Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 42507-052_5e71d345-2d68-433a-88ca-4a324c02c38d 42507-052 HUMAN OTC DRUG sleep time Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part338 HyVee Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 42507-054_8c4c786c-2b0f-4a23-a87d-effbcfe0c857 42507-054 HUMAN OTC DRUG nasal decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000911 ANDA ANDA075153 HyVee Inc PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 42507-056_2ce5f2af-cabc-466f-b0c5-256e6e6d4c88 42507-056 HUMAN OTC DRUG Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140324 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 42507-057_f71d3db1-4e48-4c49-a098-c79e03a1634f 42507-057 HUMAN OTC DRUG ibuprofen infants ibuprofen SUSPENSION ORAL 20000903 ANDA ANDA075217 HyVee Inc IBUPROFEN 50 mg/1.25mL 42507-058_69e932f9-68fc-4698-bc3e-13d6be3bfbd7 42507-058 HUMAN OTC DRUG LE TECHNIQ ANTIBACTERIAL HAND ISLAND CITRUS ETHYL ALCOHOL LIQUID TOPICAL 20141123 OTC MONOGRAPH NOT FINAL part333E HYVEE INC ALCOHOL 620 mg/mL 42507-058_8d39032c-68d6-4c04-8976-f9252579f6a8 42507-058 HUMAN OTC DRUG LE TECHNIQ ANTIBACTERIAL HAND ISLAND CITRUS ETHYL ALCOHOL LIQUID TOPICAL 20141123 OTC MONOGRAPH NOT FINAL part333E HYVEE INC ALCOHOL 620 mg/mL 42507-063_d7887d21-f6ee-493a-b0c8-4f2f9c37fbb9 42507-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19980815 OTC MONOGRAPH FINAL part347 Hy-Vee, Inc FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL 42507-065_ba6a6f11-e340-4a90-ad26-805c57f92918 42507-065 HUMAN OTC DRUG Nasal Extra Moisturizing Oxymetazoline HCl SPRAY NASAL 19990402 OTC MONOGRAPH FINAL part341 HyVee Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 42507-066_b888e446-2ac3-4947-83c8-637c258eb3ab 42507-066 HUMAN OTC DRUG Allergy Relief Extra Strength Nighttime Diphenhydramine HCl TABLET ORAL 20141130 OTC MONOGRAPH FINAL part338 Hy-Vee DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 42507-072_a957e5cb-4b0d-4da7-baca-14ede882f173 42507-072 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol MOUTHWASH ORAL 20010523 OTC MONOGRAPH NOT FINAL part348 Hy-Vee, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 42507-074_a61e7bdc-283f-4c0a-95d2-e3a0b3d0fa87 42507-074 HUMAN OTC DRUG ibuprofen ib Ibuprofen TABLET, COATED ORAL 20060514 ANDA ANDA077349 HyVee Inc IBUPROFEN 200 mg/1 42507-083_b24bb894-e5ff-4433-a372-f1590401db93 42507-083 HUMAN OTC DRUG ibu profen cold and sinus Ibuprofen, Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011015 ANDA ANDA074567 HyVee Inc IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 42507-086_7e8275a6-111b-4eed-a807-41dd29199343 42507-086 HUMAN OTC DRUG Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20101108 OTC MONOGRAPH NOT FINAL part334 Hy-Vee BISACODYL 5 mg/1 42507-090_2f6818bd-9b50-4071-a11e-dce980ed2cb7 42507-090 HUMAN OTC DRUG Night Time Day Time Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20070924 OTC MONOGRAPH FINAL part341 HyVee Inc 42507-090_6819f80c-ce43-4fa0-b985-d46145adc168 42507-090 HUMAN OTC DRUG day time night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110808 OTC MONOGRAPH FINAL part341 HyVee Inc 42507-090_9c7448a5-3c0e-4c98-9c68-a7922c042fbc 42507-090 HUMAN OTC DRUG Day Time Night Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20070924 OTC MONOGRAPH FINAL part341 HyVee Inc 42507-092_c5a04216-ed5b-495f-999b-4b94699a54ba 42507-092 HUMAN OTC DRUG Daytime Nighttime Sinus Relief Acetaminophen, Doxylamine succinate, Phenylephrine HCl KIT 20131130 OTC MONOGRAPH FINAL part341 Hy-Vee 42507-094_b5dc983c-e27a-48ab-942e-0d5a7a29ccce 42507-094 HUMAN OTC DRUG nasal decongestant pe non drowsy Phenylephrine Hydrochloride TABLET ORAL 20050523 OTC MONOGRAPH FINAL part341 HyVee Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 42507-100_a3d71451-eb8d-4c57-a39f-d01f70024cd8 42507-100 HUMAN OTC DRUG LE TECHNIQ SPRING FRESH TRICLOSAN LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN 4.6 mg/mL 42507-100_b4f112f5-4efb-4569-aa6b-ea1743e72582 42507-100 HUMAN OTC DRUG LE TECHNIQ SPRING FRESH TRICLOSAN LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN 4.6 mg/mL 42507-102_51c00675-5137-460e-9b7c-feb275cdc3bf 42507-102 HUMAN OTC DRUG DayTime NightTime Sinus Relief Acetaminophen, Doxylamine succinate, Phenylephrine HCl KIT 20130930 OTC MONOGRAPH FINAL part341 Hy-Vee 42507-105_19e83ce3-967f-4f09-8654-5723ee33a530 42507-105 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 19970828 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL 42507-110_e27976c1-07d0-48a5-bacc-2169f2a8db35 42507-110 HUMAN OTC DRUG miconazole 7 Miconazole nitrate CREAM VAGINAL 20000215 ANDA ANDA074760 HyVee Inc MICONAZOLE NITRATE 2 g/100g 42507-111_3d3aad7a-1ffc-4d10-8590-230a03b716cc 42507-111 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20140319 OTC MONOGRAPH NOT FINAL part334 HY-VEE, INC. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 42507-113_0c2595bf-4733-476d-91ae-b36e6fb2bd03 42507-113 HUMAN OTC DRUG LE TECHNIQ PEAR TRICLOSAN LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN 4.6 mg/mL 42507-113_992cdc2b-c045-460f-b7eb-ea148b579c88 42507-113 HUMAN OTC DRUG LE TECHNIQ PEAR TRICLOSAN LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN 4.6 mg/mL 42507-117_a6efcc68-599d-48b7-b4e5-452d4feb1297 42507-117 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120521 ANDA ANDA202319 HyVee Inc LANSOPRAZOLE 15 mg/1 42507-130_77302df3-f09c-48a8-8e57-147be4d221da 42507-130 HUMAN OTC DRUG Pain Relief Childrens Acetaminophen SUSPENSION ORAL 19890815 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL 42507-131_c70e2155-c510-4750-8178-7c0cf3f805d5 42507-131 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130413 ANDA ANDA078682 Hy-Vee IBUPROFEN 200 mg/1 42507-139_e0ad4934-d70f-41b0-9280-4a71f1c36b09 42507-139 HUMAN OTC DRUG cold and allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20061202 OTC MONOGRAPH FINAL part341 HyVee Inc CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 42507-140_8625c8bc-9629-4bdf-85ee-55c8aae0c956 42507-140 HUMAN OTC DRUG all day relief Naproxen sodium TABLET, FILM COATED ORAL 20080902 ANDA ANDA074661 HyVee Inc NAPROXEN SODIUM 220 mg/1 42507-141_a0f2683f-59ad-4f65-a108-696430d577ab 42507-141 HUMAN OTC DRUG acid reducer original strength Famotidine TABLET ORAL 20091019 ANDA ANDA075400 HyVee Inc FAMOTIDINE 10 mg/1 42507-145_654350c4-8421-4c21-b92e-6d197d01263a 42507-145 HUMAN OTC DRUG Mucus Relief cold and sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130708 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 42507-153_9be8b359-d644-4e76-962e-59910200bfd8 42507-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Hy-Vee Inc PYRITHIONE ZINC 1 kg/100L 42507-157_8930d88c-fb40-4606-a585-318566ef5be1 42507-157 HUMAN OTC DRUG HYVEE BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140319 OTC MONOGRAPH NOT FINAL part356 HYVEE INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42507-158_e2f1e730-f3f1-4143-ab68-1f4d42406718 42507-158 HUMAN OTC DRUG HYVEE ANTISEPTIC MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140321 OTC MONOGRAPH NOT FINAL part356 HYVEE INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42507-160_57a271a7-04f5-4c98-8259-894bbde7fbfb 42507-160 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20130311 OTC MONOGRAPH FINAL part346 HyVee Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g 42507-161_a9d9599c-06f6-464a-8e42-4a65d22de30c 42507-161 HUMAN OTC DRUG Pain and Fever Acetaminophen SUSPENSION ORAL 20110831 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL 42507-165_2707d790-97b7-4e70-ae0c-40e323032d0b 42507-165 HUMAN OTC DRUG allergy and congestion relief Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20030630 ANDA ANDA075706 HyVee Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 42507-166_5a2f449b-ceb6-4ed2-84e0-68759464ef4d 42507-166 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 20020513 ANDA ANDA074937 HyVee Inc IBUPROFEN 100 mg/5mL 42507-168_05e1d5e1-d6d7-4db7-b2c6-88e5f59c9497 42507-168 HUMAN OTC DRUG LE TECHNIQ FOAMING ANTIBACTERIAL HAND TRICLOSAN LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN 6 mg/mL 42507-174_bcf9565d-691a-41fe-acf8-a614900d58a6 42507-174 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20140930 NDA NDA021920 Hy-Vee NAPROXEN SODIUM 220 mg/1 42507-175_ca818795-1a0a-4246-a3cc-b378b9c75572 42507-175 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 19970828 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL 42507-177_43fd2065-3b2f-4580-a2b7-a45baf91be0d 42507-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN SOLUTION TOPICAL 20110808 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN .46 mL/100mL 42507-178_2aeb1a9a-d762-447a-9467-1246ef119f07 42507-178 HUMAN OTC DRUG FOAMING ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110609 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN .46 mL/100mL 42507-179_b6111740-81b6-4880-85a0-3c148ce83f32 42507-179 HUMAN OTC DRUG calcium antacid extra strength Calcium carbonate TABLET, CHEWABLE ORAL 19970715 OTC MONOGRAPH FINAL part331 HyVee Inc CALCIUM CARBONATE 750 mg/1 42507-181_b6cc8944-252e-4a5f-9463-042450d91a25 42507-181 HUMAN OTC DRUG clear lax original prescription strength Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091011 ANDA ANDA090685 HyVee Inc POLYETHYLENE GLYCOL 3350 17 g/17g 42507-184_bf5b06f1-e62c-4ea3-88d4-8f475ab92620 42507-184 HUMAN OTC DRUG Headache relief Extra Strength Acetaminophen, Aspirin and Caffeine TABLET ORAL 20121015 OTC MONOGRAPH NOT FINAL part343 Hy-Vee ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 42507-186_f4aebc3c-ba76-48d9-b6f3-89ddbcb01fb6 42507-186 HUMAN OTC DRUG Sleep Time Diphenhydramine HCl LIQUID ORAL 20130708 OTC MONOGRAPH FINAL part338 HyVee Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 42507-187_ea6db8c8-7de6-415b-9097-4ceac63b0260 42507-187 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET, COATED ORAL 19951109 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 500 mg/1 42507-188_80e3af92-0827-46ed-846c-80b1949ee4ce 42507-188 HUMAN OTC DRUG HyVee Inc Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 HyVee Inc POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 42507-189_de6ff268-a67c-4c47-977d-363312ce64af 42507-189 HUMAN OTC DRUG HyVee Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 HyVee Inc POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 42507-190_94e31d02-8de2-42b5-8882-ed3ddc211fd9 42507-190 HUMAN OTC DRUG Bisacody Enteric Coated Bisacodyl TABLET, COATED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 Hy-Vee BISACODYL 5 mg/1 42507-196_09c776c8-ecf7-4f76-bc41-5544952e2991 42507-196 HUMAN OTC DRUG cough and sore throat childrens pain relief Acetaminophen, Dextromethorphan HBr SUSPENSION ORAL 20081013 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 5 mg/5mL; mg/5mL 42507-197_93a14e19-feec-4c78-b84c-edea2bd2e71d 42507-197 HUMAN OTC DRUG HyVee Brilliant White Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 HyVee Inc SODIUM FLUORIDE .243 g/100g 42507-198_41f616c6-ea62-4f65-87a6-ce935f79a098 42507-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130115 ANDA ANDA078682 Hy-Vee IBUPROFEN 200 mg/1 42507-199_d2de97e0-b365-4ea6-95cc-310fa8943b07 42507-199 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100613 ANDA ANDA079114 HyVee Inc 42507-200_76e2c3a6-1c7b-47a1-9e74-68b474944cb0 42507-200 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET, FILM COATED ORAL 20140206 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 500 mg/1 42507-203_178743fd-5336-4aae-9a0a-5ff17aeb3762 42507-203 HUMAN OTC DRUG Childrens All Day Allergy Cetirizine HCl SOLUTION ORAL 20140217 ANDA ANDA204226 HyVee Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 42507-207_f7935672-75f3-4378-99c1-63097ffd329e 42507-207 HUMAN OTC DRUG Acid Reducer Original Strength Famotidine TABLET, COATED ORAL 20010924 ANDA ANDA075312 HyVee Inc FAMOTIDINE 10 mg/1 42507-208_677798b3-096a-417e-a68a-ccd4729fa1ee 42507-208 HUMAN OTC DRUG Cold and Flu Day Night Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20141014 OTC MONOGRAPH FINAL part341 HyVee Inc 42507-210_5585c3bc-f2d5-4710-89bc-94100ff0e79a 42507-210 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20100722 OTC MONOGRAPH NOT FINAL part348 Hy-Vee, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 42507-211_71d8b0f4-7be3-4580-ac98-ccb6de8ef3c3 42507-211 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20130930 NDA NDA022429 Hy-Vee CETIRIZINE HYDROCHLORIDE 10 mg/1 42507-213_03efde8e-67d9-416a-b01a-a876e283d900 42507-213 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20030806 OTC MONOGRAPH FINAL part355 Hy-Vee, Inc. SODIUM FLUORIDE .05 kg/100L 42507-214_be7c50b4-d30b-4955-b06b-7336f254db64 42507-214 HUMAN OTC DRUG LE TECHNIQ ANTIBACTERIAL VANILLA BROWN SUGAR TRICLOSAN LIQUID TOPICAL 20110609 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN .115 mL/100mL 42507-215_f3f87cac-8cff-4c55-bfc1-a1b3220e9ec8 42507-215 HUMAN OTC DRUG day time cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20110325 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 42507-217_fe4b3e75-56bb-483f-987e-f92d5d6b3fdf 42507-217 HUMAN OTC DRUG 8 hour pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050923 ANDA ANDA075077 HyVee Inc ACETAMINOPHEN 650 mg/1 42507-220_05be8eb5-0e55-48d7-913d-e9dfaae0e59c 42507-220 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN .15 mL/100mL 42507-224_9434cefe-6b13-47c4-b2f7-b8d566c5a4ff 42507-224 HUMAN OTC DRUG anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030321 ANDA ANDA075232 HyVee Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 42507-227_d9853d99-557b-45eb-89c3-deca6c1a8ec4 42507-227 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET, COATED ORAL 20060123 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 500 mg/1 42507-230_9fad1dd8-6298-4dc5-8496-d6900a69cdd5 42507-230 HUMAN OTC DRUG nighttime sleep aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20141124 OTC MONOGRAPH FINAL part338 HyVee Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 42507-234_88ecdfb1-9c1a-432b-80fa-844f0223579d 42507-234 HUMAN OTC DRUG cold pain relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 19910215 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 42507-236_77c4e0fa-ca3b-4dbd-b52e-d43f326f56fb 42507-236 HUMAN OTC DRUG Night Time Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Hy-Vee DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 42507-238_a7ca46b3-276f-4025-95ec-268dca08b7ea 42507-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130808 OTC MONOGRAPH NOT FINAL part334 Hy-Vee DOCUSATE SODIUM 100 mg/1 42507-240_934185ee-8f44-493c-b196-a548a22a467e 42507-240 HUMAN OTC DRUG FOAMING HAND SANITIZER BENZALKONIUM CHLORIDE GEL TOPICAL 20111024 OTC MONOGRAPH NOT FINAL part333E HY-VEE INC BENZALKONIUM CHLORIDE .1 mL/100mL 42507-244_c330e908-dc90-49f1-ab3c-9bd6e4ffe70c 42507-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH NOT FINAL part334 Hy-Vee DOCUSATE SODIUM 100 mg/1 42507-247_b99a8396-2eb2-4bcc-8227-df59bccb127b 42507-247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140328 OTC MONOGRAPH NOT FINAL part343 Hy-Vee ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 42507-250_34e4c89d-469b-48a1-98c8-7801cbdc46be 42507-250 HUMAN OTC DRUG cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20070924 OTC MONOGRAPH FINAL part341 HyVee Inc 42507-255_35de0a2b-0586-4480-954c-7a1616321ad0 42507-255 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20050226 ANDA ANDA075217 HyVee Inc IBUPROFEN 50 mg/1.25mL 42507-258_7a47dc23-36c1-4e21-8410-ae04a757b557 42507-258 HUMAN OTC DRUG STOOL SOFTENER Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 Hy-Vee DOCUSATE SODIUM 250 mg/1 42507-262_a9d41098-c485-4947-9e5a-babae14e7298 42507-262 HUMAN OTC DRUG LE TECHNIQ hAND SANITIZER APPLE POMEGRANATE ETHYL ALCOHOL LIQUID TOPICAL 20141116 OTC MONOGRAPH NOT FINAL part333E HYVEE INC ALCOHOL 620 mg/mL 42507-262_eed8cac7-f872-4471-bdbe-f008151a405a 42507-262 HUMAN OTC DRUG LE TECHNIQ hAND SANITIZER APPLE POMEGRANATE ETHYL ALCOHOL LIQUID TOPICAL 20141116 OTC MONOGRAPH NOT FINAL part333E HYVEE INC ALCOHOL 620 mg/mL 42507-266_41508428-344d-448e-8bce-a08e13ab8010 42507-266 HUMAN OTC DRUG LE TECHNIQ HAND SANITIZER JASMINE BASIL ETHYL ALCOHOL LIQUID TOPICAL 20141116 OTC MONOGRAPH NOT FINAL part333E HYVEE INC ALCOHOL 620 mg/mL 42507-266_d8ea613c-1b3e-403f-9732-f61fb823235f 42507-266 HUMAN OTC DRUG LE TECHNIQ hAND SANITIZER JASMINE BASIL ETHYL ALCOHOL LIQUID TOPICAL 20141116 OTC MONOGRAPH NOT FINAL part333E HYVEE INC ALCOHOL 620 mg/mL 42507-268_453f692d-d2e6-4dec-813a-fcfefc82afdb 42507-268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part356 Hy-Vee HYDROGEN PEROXIDE 2.65 mL/100mL 42507-271_4074858e-8269-4287-b7ee-550685c78633 42507-271 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20091123 ANDA ANDA076760 HyVee Inc RANITIDINE HYDROCHLORIDE 75 mg/1 42507-272_8610eccf-d5bf-47b8-9f4b-35590d4c496b 42507-272 HUMAN OTC DRUG Sinus Congestion and Pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20070211 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 42507-274_c9d2e2d8-e135-45c0-89fd-3dd3cc36b3ad 42507-274 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 19970725 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ASPIRIN 81 mg/1 42507-275_7a568026-5916-402b-823b-544324779a9c 42507-275 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70 Percent Isopropyl Alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A Hy-Vee ISOPROPYL ALCOHOL 70 mL/100mL 42507-277_8750bdd0-3c92-428b-890d-a7d158bf2f9f 42507-277 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A Hy-Vee ISOPROPYL ALCOHOL 91 mL/100mL 42507-281_617d33cd-eba3-4ac6-b0ee-13991caa0fe6 42507-281 HUMAN OTC DRUG Dry Scalp Dandruff Pyrithione Zince SHAMPOO TOPICAL 20020719 OTC MONOGRAPH FINAL part358H Hy-Vee, Inc PYRITHIONE ZINC 1 kg/100L 42507-282_d0daae1c-f6fb-4a23-9aa9-0f68b1aea3c7 42507-282 HUMAN OTC DRUG Dayhist allergy Clemastine fumarate TABLET ORAL 19960621 ANDA ANDA074512 HyVee Inc CLEMASTINE FUMARATE 1.34 mg/1 42507-289_71095069-7cc3-405d-bfdc-088b4d246e39 42507-289 HUMAN OTC DRUG pain relief infants Acetaminophen SUSPENSION/ DROPS ORAL 19970925 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 80 mg/.8mL 42507-295_65140bd1-e731-4611-96a4-9116d465fe1b 42507-295 HUMAN OTC DRUG ANTIBACTERIAL CUCUMBER MELON TRICLOSAN LIQUID TOPICAL 20110609 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN .115 mL/100mL 42507-296_f1d7e3c5-ba7c-45e1-b047-b34911ff055b 42507-296 HUMAN OTC DRUG tussin maximum strength dextromethorphan hbr, guaifenesin, phenylephrine hcl SUSPENSION ORAL 20130225 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL 42507-298_1ed16cb4-f00f-489e-8f94-efe48c805ae0 42507-298 HUMAN OTC DRUG LE TECHNIQ SPRING FRESH TRICLOSAN LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN 1.5 mg/mL 42507-298_a177302a-193f-467e-aa55-7767ea04d69d 42507-298 HUMAN OTC DRUG LE TECHNIQ SPRING FRESH TRICLOSAN LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN 1.5 mg/mL 42507-299_767e8000-92a7-45ac-b878-614bda8a7fc1 42507-299 HUMAN OTC DRUG Antiseptic Cetylpyridinium chloride 0.07% MOUTHWASH ORAL 20100218 OTC MONOGRAPH NOT FINAL part356 Hy-Vee, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL 42507-300_e29bfe0d-1fa0-4c98-9962-ccb287ceb6aa 42507-300 HUMAN OTC DRUG Tussin Cough Long Acting Dextromethorphan Hydrobromide LIQUID ORAL 19951109 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL 42507-302_82217ae0-d907-4d6a-a026-32ccecc9ce6d 42507-302 HUMAN OTC DRUG stomach relief original strength Bismuth subsalicylate SUSPENSION ORAL 19890215 OTC MONOGRAPH FINAL part335 HyVee Inc BISMUTH SUBSALICYLATE 525 mg/30mL 42507-304_d997f264-1b4a-4cca-a282-bd9645d55bfd 42507-304 HUMAN OTC DRUG nasal original oxymetazoline hydrochloride SPRAY NASAL 19911118 OTC MONOGRAPH FINAL part341 HyVee Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 42507-306_0f45a719-73fe-4911-adfc-f9740d7b6747 42507-306 HUMAN OTC DRUG clear lax original prescription strength Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091011 ANDA ANDA090685 HyVee Inc POLYETHYLENE GLYCOL 3350 17 g/17g 42507-308_17c81bf7-ca0a-4876-938d-b4284dd0e606 42507-308 HUMAN OTC DRUG Cough Relief Grape Dextromethorphan HBr LIQUID ORAL 20090529 OTC MONOGRAPH FINAL part341 Hy-Vee DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 42507-310_2d0e8475-eb77-4686-aca8-783f9cf33fea 42507-310 HUMAN OTC DRUG adult tussin chest congestion Guaifenesin SYRUP ORAL 19970625 OTC MONOGRAPH FINAL part341 HyVee Inc GUAIFENESIN 100 mg/5mL 42507-311_5ef625fd-2b1c-4cb5-a9cc-6ab53917d70f 42507-311 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20061116 OTC MONOGRAPH FINAL part358H Hy-Vee Inc PYRITHIONE ZINC 1 kg/100L 42507-318_45153121-5c13-416a-a4c2-a683e2299bc2 42507-318 HUMAN OTC DRUG Antiseptic Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 19900815 OTC MONOGRAPH NOT FINAL part356 Hy-Vee Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42507-321_237efe92-b302-4e11-93fe-7b0f727a00aa 42507-321 HUMAN OTC DRUG complete dual action famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080811 ANDA ANDA077355 HyVee Inc CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 42507-323_f2697a19-a69c-43d9-8959-55e3b1f49383 42507-323 HUMAN OTC DRUG lubricating plus carboxymethylcellulose sodium SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130506 OTC MONOGRAPH FINAL part349 HyVee Inc CARBOXYMETHYLCELLULOSE SODIUM .5 g/100mL 42507-328_0180ce79-8da0-445e-a45f-93cc6704563b 42507-328 HUMAN OTC DRUG sore throat Phenol SPRAY ORAL 19921119 OTC MONOGRAPH NOT FINAL part356 HyVee Inc PHENOL 1.4 g/100mL 42507-330_e8048e46-cf79-4230-979b-1de9c1d783bf 42507-330 HUMAN OTC DRUG Congestion Relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20141006 ANDA ANDA203200 HyVee Inc IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 42507-332_6f425779-f6af-42d3-8b5b-4f7a7b1b49dd 42507-332 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide LIQUID ORAL 19970502 OTC MONOGRAPH NOT FINAL part334 HyVee Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 42507-333_1810f2e9-34be-4361-8ece-f956046ffeac 42507-333 HUMAN OTC DRUG Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20131202 OTC MONOGRAPH FINAL part346 HyVee Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 42507-335_2416c169-e881-4771-937a-0b1693970011 42507-335 HUMAN OTC DRUG night time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110921 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 42507-337_c4e1aafc-1ab3-456f-b30c-888e9cb0f21a 42507-337 HUMAN OTC DRUG stomach relief Maximum Strength Bismuth subsalicylate SUSPENSION ORAL 19890715 OTC MONOGRAPH FINAL part335 HyVee Inc BISMUTH SUBSALICYLATE 1050 mg/30mL 42507-340_7deeb705-b904-4223-ae92-0cab0e855f32 42507-340 HUMAN OTC DRUG antacid aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 19911021 OTC MONOGRAPH FINAL part331 HyVee Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 42507-345_cb19f315-4a7f-45c0-85cf-6a1251a1fb37 42507-345 HUMAN OTC DRUG severe sinus congestion Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140519 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 42507-355_2ffd1d49-6825-4ed9-8a5d-b357b7b00ce9 42507-355 HUMAN OTC DRUG headache pm formula Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19980830 OTC MONOGRAPH FINAL part338 HyVee Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 42507-359_3e5f60c0-8ae1-404d-9019-b8cfd9a72757 42507-359 HUMAN OTC DRUG Tussin DM Adult Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19951010 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 42507-368_59c655b7-7303-4b08-a1aa-eb39f02931e7 42507-368 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET, FILM COATED ORAL 19970401 ANDA ANDA074661 HyVee Inc NAPROXEN SODIUM 220 mg/1 42507-370_f39d1fe2-93bd-4110-bf17-90e2891929bf 42507-370 HUMAN OTC DRUG Aspirin Safety Coated Aspirin TABLET, COATED ORAL 20140531 OTC MONOGRAPH FINAL part343 Hy-Vee ASPIRIN 325 mg/1 42507-371_6552a74e-0edf-4c89-87ca-f233e9dfaf61 42507-371 HUMAN OTC DRUG pain relief cold multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 19890115 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 42507-373_4d101e67-52d2-4eca-a72a-2be7767d7499 42507-373 HUMAN OTC DRUG cold and cough Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20140602 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 42507-374_bb194bb0-5458-4140-80a2-d1729eb91a9c 42507-374 HUMAN OTC DRUG migraine formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20020909 ANDA ANDA075794 HyVee Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 42507-379_75b19163-db1c-42fc-8bbb-364be16b9b2f 42507-379 HUMAN OTC DRUG allergy Diphenhydramine HCl LIQUID ORAL 19921111 OTC MONOGRAPH FINAL part341 HyVee Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 42507-381_595ef095-06e2-42a8-9a2a-1a6be238b924 42507-381 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130624 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 42507-384_5797131d-920a-4773-9e1f-0d64a898baa5 42507-384 HUMAN OTC DRUG cough dm dextromethorphan polistirex SUSPENSION ORAL 20120902 ANDA ANDA091135 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 42507-388_75cb03f0-f908-4fa7-a442-1a31754105c5 42507-388 HUMAN OTC DRUG nasal Oxymetazoline HCl SPRAY NASAL 20020513 OTC MONOGRAPH FINAL part341 HyVee Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 42507-393_8cad15c8-c525-4423-bbbf-7243333dfba2 42507-393 HUMAN OTC DRUG cold pe Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070527 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 42507-394_90d57d84-b9e9-4fdf-adc8-42ce37aeef0f 42507-394 HUMAN OTC DRUG hemorrhoidal Cocoa butter, Phenylephrine HCl, Shark liver oil SUPPOSITORY RECTAL 19980810 OTC MONOGRAPH FINAL part346 HyVee Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2137.5; 75; 6.375 mg/1; mg/1; mg/1 42507-396_7ed46e76-2dbd-4cf2-a049-f480105bb773 42507-396 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide LIQUID ORAL 19970205 OTC MONOGRAPH NOT FINAL part334 HyVee Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 42507-400_1c90f055-353d-4918-b310-a93724d59dce 42507-400 HUMAN OTC DRUG Hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 19970625 OTC MONOGRAPH FINAL part346 HyVee Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 42507-401_a16a85c2-e1fd-4d1a-a650-271ae430eb4f 42507-401 HUMAN OTC DRUG Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20140115 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 42507-402_e99d4e82-c094-4df9-8fc9-b055542c4478 42507-402 HUMAN OTC DRUG Pain Relief Cold Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070428 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 42507-403_577e2ea6-2202-4558-b8a3-b6ed4a818654 42507-403 HUMAN OTC DRUG pain relief regular strength Acetaminophen TABLET ORAL 19881215 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 325 mg/1 42507-405_702a3603-3f65-4a05-a9be-52454aa47442 42507-405 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET ORAL 19890115 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 500 mg/1 42507-406_d8f6210b-68b9-4e57-909b-19e0b8767e55 42507-406 HUMAN OTC DRUG HyVee Cold Sore Treatment Benzalkonium Chloride CREAM TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part333A Hyvee BENZALKONIUM CHLORIDE 1.3 mg/g 42507-409_e6a27d4f-ba7d-4fac-b9c0-060b867147bb 42507-409 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19960528 OTC MONOGRAPH FINAL part340 HyVee Inc CAFFEINE 200 mg/1 42507-417_b8dc7343-8ad5-46ad-8088-2165c7c20b6b 42507-417 HUMAN OTC DRUG All Day Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130812 ANDA ANDA076518 HyVee Inc NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 42507-425_7ccd69a2-eacf-4576-b710-8f8632eb417b 42507-425 HUMAN OTC DRUG fexofenadine Fexofenadine HCl TABLET, FILM COATED ORAL 20111024 ANDA ANDA076447 HyVee Inc FEXOFENADINE HYDROCHLORIDE 60 mg/1 42507-428_95951daa-ec85-426c-b88a-addeb5670e1c 42507-428 HUMAN OTC DRUG gas relief extra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20030821 OTC MONOGRAPH FINAL part332 HyVee Inc DIMETHICONE 125 mg/1 42507-430_d58d9cea-1c6d-463c-8737-931c418ac022 42507-430 HUMAN OTC DRUG headache formula added strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19920117 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 42507-431_452a7643-d5af-4fdc-b8fc-82f3f732b758 42507-431 HUMAN OTC DRUG sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20010223 OTC MONOGRAPH FINAL part338 HyVee Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 42507-432_e32f5fc6-b248-48d6-ac16-5270785fb9ec 42507-432 HUMAN OTC DRUG nasal decongestant non drowsy Pseudoephedrine HCl TABLET, FILM COATED ORAL 19890115 OTC MONOGRAPH FINAL part341 HyVee Inc PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 42507-437_7d997f9c-5192-4d62-92a7-ce56cf8d1cfe 42507-437 HUMAN OTC DRUG Pain Relief PM Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19921119 OTC MONOGRAPH FINAL part338 HyVee Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 42507-441_86c7d568-bcd9-43fa-adc8-4cfdfb57558a 42507-441 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 19980901 ANDA ANDA040167 HyVee Inc DOXYLAMINE SUCCINATE 25 mg/1 42507-444_a3040890-b89e-4966-9ceb-4a6bd15536b9 42507-444 HUMAN OTC DRUG tussin multi symptom Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20141110 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 42507-458_fb5b0cd9-90e9-4afe-961b-0da80132f423 42507-458 HUMAN OTC DRUG All Day Allergy Cetirizine Hydrochloride TABLET ORAL 19970828 ANDA ANDA078336 HyVee Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 42507-459_3bbbcf53-5a89-4d1f-a52c-5566b0955a1c 42507-459 HUMAN OTC DRUG night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110811 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 42507-461_2fd51545-1d1f-4b2e-a084-d28ba223e720 42507-461 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20050212 ANDA ANDA076359 HyVee Inc IBUPROFEN 100 mg/1 42507-462_3ae9c0c7-e240-465f-8d23-5ae75a54ee53 42507-462 HUMAN OTC DRUG allergy diphenhydramine hydrochloride CAPSULE ORAL 19881215 OTC MONOGRAPH FINAL part341 HyVee Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 42507-463_2b4c46de-93be-41f5-82bd-38a6414315a1 42507-463 HUMAN OTC DRUG Allergy Chlorpheniramine Maleate TABLET ORAL 19910730 OTC MONOGRAPH FINAL part341 HyVee Inc CHLORPHENIRAMINE MALEATE 4 mg/1 42507-467_8a84f3e4-af5d-4583-8049-415a4520ded1 42507-467 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 19951109 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ASPIRIN 81 mg/1 42507-468_e6d22143-f53d-4e42-9386-b32c0498d702 42507-468 HUMAN OTC DRUG antacid Calcium carbonate TABLET, CHEWABLE ORAL 19961007 OTC MONOGRAPH FINAL part331 HyVee Inc CALCIUM CARBONATE 750 mg/1 42507-469_bce537a3-6662-4a0c-ae8e-b3ad81d4cc82 42507-469 HUMAN OTC DRUG stomach relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 19910806 OTC MONOGRAPH FINAL part335 HyVee Inc BISMUTH SUBSALICYLATE 262 mg/1 42507-473_d8b112df-4146-402e-bcda-be938d360c25 42507-473 HUMAN OTC DRUG day time cough Dextromethorphan HBr LIQUID ORAL 20071001 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE 15 mg/15mL 42507-476_97d17ac5-9a8e-4c61-b46d-0ab7271859f5 42507-476 HUMAN OTC DRUG allergy pain relief Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20060204 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 42507-477_94baeee4-6d29-465c-8127-1cb0175a7a1b 42507-477 HUMAN OTC DRUG fiber laxative Calcium polycarbophil TABLET, FILM COATED ORAL 19980706 OTC MONOGRAPH NOT FINAL part334 HyVee Inc CALCIUM POLYCARBOPHIL 625 mg/1 42507-478_2a2d65d1-0e81-455c-beb1-3887b9fd2720 42507-478 HUMAN OTC DRUG antacid calcium carbonate TABLET, CHEWABLE ORAL 19920828 OTC MONOGRAPH FINAL part331 HyVee Inc CALCIUM CARBONATE 500 mg/1 42507-480_ee2a43cd-3194-4b01-89ad-29733ca9f872 42507-480 HUMAN OTC DRUG LE TECHNIQ ALOE ETHYL ALCOHOL LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC ALCOHOL 700 mg/mL 42507-484_7d7df4eb-d4bc-4f02-b9d9-4ea966acc4f2 42507-484 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET ORAL 19910515 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 500 mg/1 42507-485_8e6b204a-3060-4cb0-9f9f-1356d2511c36 42507-485 HUMAN OTC DRUG Antacid calcium carbonate TABLET, CHEWABLE ORAL 19890115 OTC MONOGRAPH FINAL part331 HyVee Inc CALCIUM CARBONATE 500 mg/1 42507-486_3b81012b-905a-4bb2-a24f-c46c8a0461e5 42507-486 HUMAN OTC DRUG stool softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 19980901 OTC MONOGRAPH NOT FINAL part334 HyVee Inc DOCUSATE SODIUM 100 mg/1 42507-489_afe04a01-b82d-416a-9602-efecf7e6cb9a 42507-489 HUMAN OTC DRUG antacid Calcium carbonate TABLET, CHEWABLE ORAL 20010223 OTC MONOGRAPH FINAL part331 HyVee Inc CALCIUM CARBONATE 750 mg/1 42507-490_e593d39d-64d1-40be-b853-276c23a9db18 42507-490 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET ORAL 19970401 ANDA ANDA074661 HyVee Inc NAPROXEN SODIUM 220 mg/1 42507-498_1a375cf0-965a-4a77-b40a-1e2f322e96c6 42507-498 HUMAN OTC DRUG mucus er Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130318 ANDA ANDA078912 HyVee Inc GUAIFENESIN 600 mg/1 42507-499_ea93327c-4f9a-438d-96bf-1e205ad5d545 42507-499 HUMAN OTC DRUG LE TECHNIQ ALOE ETHYL ALCOHOL LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC ALCOHOL 700 mg/mL 42507-500_901cfa98-ff70-4779-bdeb-e55372d6200f 42507-500 HUMAN OTC DRUG Cough Dextromethorphan HBr LIQUID ORAL 20140212 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE 15 mg/15mL 42507-516_f8c86c63-281b-40dc-9f64-ba88961bd906 42507-516 HUMAN OTC DRUG Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 19890115 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 42507-517_52cf3483-d5ec-4b35-9357-e02bbd88cc6a 42507-517 HUMAN OTC DRUG ibuprofen ib Ibuprofen TABLET, FILM COATED ORAL 20060521 ANDA ANDA077349 HyVee Inc IBUPROFEN 200 mg/1 42507-522_d5bbb5e1-ff09-4563-b2c6-149ab30e06ad 42507-522 HUMAN OTC DRUG Cold and Flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20140110 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 42507-528_d35690a2-c02a-4652-998e-bc24b3a56e0d 42507-528 HUMAN OTC DRUG Antacid CALCIUM CARBONATE TABLET, CHEWABLE ORAL 19961120 OTC MONOGRAPH FINAL part331 HyVee Inc CALCIUM CARBONATE 750 mg/1 42507-535_f5927ffb-e586-4fec-8e76-8fd371330b52 42507-535 HUMAN OTC DRUG Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 19970625 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ASPIRIN 81 mg/1 42507-539_7828f4e0-c541-4966-9efa-3915f5d21017 42507-539 HUMAN OTC DRUG allergy relief Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20140922 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 42507-544_31faafb2-6593-484c-affc-6221c02ecf90 42507-544 HUMAN OTC DRUG arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051106 ANDA ANDA075077 HyVee Inc ACETAMINOPHEN 650 mg/1 42507-546_9af68318-4bb3-4df9-853c-d08647a8cb74 42507-546 HUMAN OTC DRUG complete dual action Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080811 ANDA ANDA077355 HyVee Inc CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 42507-548_522b85b5-d17b-4038-b4c6-18b8a0ce2d45 42507-548 HUMAN OTC DRUG Severe Cold and Flu acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140201 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 42507-552_89c33d7c-9a32-4369-ae42-40470b9b103a 42507-552 HUMAN OTC DRUG HYVEE COMPLETE CARE FRESH MINT SODIUM FLUORIDE LIQUID ORAL 20130912 OTC MONOGRAPH FINAL part355 HYVEE INC. SODIUM FLUORIDE .2 mg/mL 42507-553_8266845c-3393-4789-a189-481cbeb228d6 42507-553 HUMAN OTC DRUG HYVEE PRO CLEAN BLUE MINT CETYLPYRIDINIUM CHLORIDE LIQUID ORAL 20130912 OTC MONOGRAPH NOT FINAL part356 HYVEE INC. CETYLPYRIDINIUM CHLORIDE .7 mg/mL 42507-554_833558d7-a048-4e19-b08f-1a1c7d58512a 42507-554 HUMAN OTC DRUG HYVEE ANTICAVITY MINT SODIUM FLUORIDE LIQUID ORAL 20130912 OTC MONOGRAPH FINAL part355 HYVEE INC. SODIUM FLUORIDE .5 mg/mL 42507-556_7bbb813b-9836-4b8f-b2b0-04421aa1c535 42507-556 HUMAN OTC DRUG HYVEE ANTISEPTIC ORIGINAL EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130912 OTC MONOGRAPH NOT FINAL part356 HYVEE INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42507-556_841a02ad-658b-4ea2-ba10-11115f3ba570 42507-556 HUMAN OTC DRUG HYVEE ANTISEPTIC ORIGINAL EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130912 OTC MONOGRAPH NOT FINAL part356 HYVEE INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42507-557_9cf200be-acff-4fe7-bad0-1a1cdbaadfcb 42507-557 HUMAN OTC DRUG HYVEE ANTISEPTIC MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130912 OTC MONOGRAPH NOT FINAL part356 HYVEE INC. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42507-557_b9b42143-8af4-465e-881f-28851cc4058a 42507-557 HUMAN OTC DRUG HYVEE ANTISEPTIC MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130912 OTC MONOGRAPH NOT FINAL part356 HYVEE INC. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42507-558_3cb056b0-1501-414b-b413-b28bb7a15545 42507-558 HUMAN OTC DRUG HYVEE ANTISEPTIC BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130912 OTC MONOGRAPH NOT FINAL part356 HYVEE INC. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42507-558_ce7e359e-f064-4874-a5a2-b9782f4b384e 42507-558 HUMAN OTC DRUG HYVEE ANTISEPTIC BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130912 OTC MONOGRAPH NOT FINAL part356 HYVEE INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42507-567_52b34580-00a0-4988-bc8a-ef481094eab9 42507-567 HUMAN OTC DRUG Night Time Day Time Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120105 OTC MONOGRAPH FINAL part341 HyVee Inc 42507-567_71df4af2-027c-4658-86e9-101919de096b 42507-567 HUMAN OTC DRUG Day Time Night Time Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120101 OTC MONOGRAPH FINAL part341 HyVee Inc 42507-571_8341d047-b6b4-4ce3-a65e-a23e6f55e5be 42507-571 HUMAN OTC DRUG fexo fenadine fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110417 ANDA ANDA076447 HyVee Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 42507-578_6f32db77-cb37-444a-853c-6fbfe30696b9 42507-578 HUMAN OTC DRUG tussin dm adult Dextromethorphan HBr, Guaifenesin LIQUID ORAL 19961120 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 42507-580_aff579e2-7fb3-4407-b371-40d48317c695 42507-580 HUMAN OTC DRUG Day Night Cold and Flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140702 OTC MONOGRAPH FINAL part341 HyVee Inc 42507-588_d89b6971-f078-429f-87fd-219b24ca29ed 42507-588 HUMAN OTC DRUG Antacid Maximum Strength Aluminum Hydroxide, Magnesium Hydroxide, Simethicone LIQUID ORAL 20060730 OTC MONOGRAPH FINAL part332 HyVee Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 42507-590_040b1c43-d523-41b8-8438-50f97f5c8141 42507-590 HUMAN OTC DRUG pain and fever acetaminophen SUSPENSION ORAL 19930805 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL 42507-595_52a5a13b-7d4b-4fb9-a32e-e0bff9b899a5 42507-595 HUMAN OTC DRUG antacid Calcium Carbonate TABLET, CHEWABLE ORAL 19961120 OTC MONOGRAPH FINAL part331 HyVee Inc CALCIUM CARBONATE 1000 mg/1 42507-597_d4bcfabb-a054-4f53-8dc9-d361a03558b8 42507-597 HUMAN OTC DRUG Severe Cold and Flu Nighttime Daytime acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140519 OTC MONOGRAPH FINAL part341 HyVee Inc 42507-603_5a0ef8ae-f6d5-4388-b4da-6b7f025160b2 42507-603 HUMAN OTC DRUG Severe Cold and Flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SUSPENSION ORAL 20140112 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 42507-604_e7175dc9-db39-4452-a419-85af179de422 42507-604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19910315 ANDA ANDA072096 HyVee Inc IBUPROFEN 200 mg/1 42507-609_f568e6ac-a921-4491-9fec-f75c4a37b295 42507-609 HUMAN OTC DRUG Nighttime D Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID ORAL 19940214 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 500; 15; 6.25; 30 mg/15mL; mg/15mL; mg/15mL; mg/15mL 42507-611_df65908c-79a0-42f0-aec6-fb009aef6016 42507-611 HUMAN OTC DRUG LeThechniq Dandruff Moisturizing Selenium Sulfide SHAMPOO TOPICAL 20101015 OTC MONOGRAPH FINAL part358H HY-VEE, Inc SELENIUM SULFIDE 1 mL/100mL 42507-612_626b858f-5952-4c0e-994a-74785067ac0f 42507-612 HUMAN OTC DRUG Allergy Relief Loratadine TABLET ORAL 20050523 ANDA ANDA076301 HyVee Inc LORATADINE 10 mg/1 42507-620_6232c831-7b01-49ae-8781-52fbe4b4d825 42507-620 HUMAN OTC DRUG Motion Sickness Meclizine HCl TABLET ORAL 20140328 OTC MONOGRAPH FINAL part336 Hy-Vee MECLIZINE HYDROCHLORIDE 25 mg/1 42507-645_4d674723-f5f9-4e98-acd7-8b4165e1031f 42507-645 HUMAN OTC DRUG loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120430 ANDA ANDA091292 HyVee Inc LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 42507-647_4c24c884-55f7-40b4-8d6f-db6144d5ebcb 42507-647 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 19890715 ANDA ANDA072096 HyVee Inc IBUPROFEN 200 mg/1 42507-648_19879fc8-4962-4c6e-87ed-b874d1d564af 42507-648 HUMAN OTC DRUG Nasal Four Phenylephrine hydrochloride SPRAY NASAL 20030503 OTC MONOGRAPH FINAL part341 HyVee Inc PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 42507-656_d7980971-5bd3-4e15-971d-71b0e82517b7 42507-656 HUMAN OTC DRUG day time acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20060611 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 42507-660_a1a4a0f0-4a5f-4040-a3e8-765d1e4a375b 42507-660 HUMAN OTC DRUG Ibuprofen childrens Ibuprofen SUSPENSION ORAL 20020401 ANDA ANDA074937 HyVee Inc IBUPROFEN 100 mg/5mL 42507-664_f2d3f64e-e7c1-4c07-9bb3-f00df65109a4 42507-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19921120 OTC MONOGRAPH NOT FINAL part356 Hy-Vee, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 42507-666_aa21d296-46ad-48d3-8fd7-ea717e1ac3ae 42507-666 HUMAN OTC DRUG cough and sore throat pain relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20080720 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 42507-668_db52ea79-55e0-4725-a0ba-ede531f1a50d 42507-668 HUMAN OTC DRUG Nighttime Cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20030420 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 42507-678_d506eee7-4111-4e15-ad02-77ce750dcd1a 42507-678 HUMAN OTC DRUG Hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20121210 OTC MONOGRAPH FINAL part346 HyVee Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 42507-685_1962d7e2-e439-4056-8c04-95e0bc580167 42507-685 HUMAN OTC DRUG Ibuprofen Ibuprofen LIQUID ORAL 19970930 ANDA ANDA074937 HyVee Inc IBUPROFEN 100 mg/5mL 42507-688_5db0c5ae-25b7-424a-ba35-93c4fd852363 42507-688 HUMAN OTC DRUG sinus relief Oxymetazoline HCl SPRAY NASAL 20091207 OTC MONOGRAPH FINAL part341 HyVee Inc OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL 42507-692_2d907ff8-d171-448c-9364-f5880f97ceda 42507-692 HUMAN OTC DRUG allergy relief fexofenadine hcl TABLET, FILM COATED ORAL 20140212 ANDA ANDA076447 HyVee Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 42507-700_1f3efcdd-4976-4aef-a7c6-a5f88d13cb78 42507-700 HUMAN OTC DRUG cold and flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20140924 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 42507-702_8ddf74b2-4ba5-4909-8a0f-1cc82b9522b1 42507-702 HUMAN OTC DRUG Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20140307 OTC MONOGRAPH FINAL part341 HyVee Inc 42507-705_bee62d7b-cf16-400e-b8aa-541382e1798d 42507-705 HUMAN OTC DRUG mucus relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20141001 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 42507-719_6e757d28-b6df-471e-a781-4a374b4efe79 42507-719 HUMAN OTC DRUG LE TECHNIQ MORNING MIST ANTIBACTERIAL HAND TRICLOSAN LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN 1.15 mg/mL 42507-720_47876240-6fd7-494e-bcac-95cd8964c961 42507-720 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110609 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN .115 mL/100mL 42507-720_5ee1ecd3-fa1b-4b72-89b3-7e2052a14274 42507-720 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110609 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN .115 mL/100mL 42507-721_6bfa55be-68f5-42ba-b947-c913edfc4fc0 42507-721 HUMAN OTC DRUG LE TECHNIQ LIGHT MOISTURIZING BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC BENZALKONIUM CHLORIDE 1.3 mg/mL 42507-721_c42c3ef2-6057-410a-8d4c-d7b465b6f019 42507-721 HUMAN OTC DRUG LE TECHNIQ LIGHT MOISTURIZING BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC BENZALKONIUM CHLORIDE 1.3 mg/mL 42507-724_e7de712c-d94e-45d5-9448-af643fa2e3be 42507-724 HUMAN OTC DRUG allergy and congestion relief non drowsy Pseudoephedrine sulfate, Loratadine TABLET, FILM COATED ORAL 20101026 ANDA ANDA075989 HyVee Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 42507-737_9f2cf8fd-deab-4364-8b64-867c7bb37ddc 42507-737 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100613 ANDA ANDA079114 HyVee Inc 42507-742_833dcd72-045b-4fd4-ab92-62c0b0e52fc5 42507-742 HUMAN OTC DRUG Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20101129 NDA NDA021920 HyVee Inc NAPROXEN SODIUM 220 mg/1 42507-751_e9b05ddc-afc2-4b57-ad34-fdaadf325e81 42507-751 HUMAN OTC DRUG pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120507 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 42507-759_ed74cb1d-b8f0-456b-b192-54b5a3cfffbb 42507-759 HUMAN OTC DRUG pain relief Acetaminophen SUSPENSION ORAL 20110919 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL 42507-763_4f963491-e1f0-494d-acb6-5f4d2b267d4a 42507-763 HUMAN OTC DRUG Severe Cold and Flu Night time Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl LIQUID ORAL 20140112 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 42507-766_53184e1d-6c19-4ec9-be25-32ef7f73dc11 42507-766 HUMAN OTC DRUG infants pain and fever Acetaminophen SUSPENSION ORAL 20120305 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL 42507-799_019d6575-f17d-468c-ae92-d5183c4cbea8 42507-799 HUMAN OTC DRUG tussin dm max adult cough and chest congestion Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20100809 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/5mL; mg/5mL 42507-801_7d40d41a-d241-4a12-9b81-b42545dc9578 42507-801 HUMAN OTC DRUG Antibacterial Body Wash Spring Water 2 in 1 Triclosan SOAP TOPICAL 20100922 OTC MONOGRAPH NOT FINAL part333E HY-VEE, Inc TRICLOSAN .15 mL/100mL 42507-807_d80c124b-cda1-40f6-84e1-be05dcb07b38 42507-807 HUMAN OTC DRUG cold remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20080811 UNAPPROVED HOMEOPATHIC HyVee Inc ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 42507-810_c7425a30-802e-4585-bc5a-02e32e2c60fb 42507-810 HUMAN OTC DRUG Sinus and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20140228 OTC MONOGRAPH FINAL part341 Hy-Vee CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 42507-815_f1a9c8b4-6e55-4698-8272-6558f2e648dc 42507-815 HUMAN OTC DRUG HyVee Alcohol Prep Pads Isopropyl Alcohol SWAB TOPICAL 20140507 OTC MONOGRAPH NOT FINAL part333A HY-VEE, INC. ISOPROPYL ALCOHOL 70 mL/100mL 42507-829_cd3487af-ea75-49e4-8e36-ecbc0d270531 42507-829 HUMAN OTC DRUG pain relief pm extra strength Acetaminophen, Diphenhydramine HCl CAPSULE, COATED ORAL 20100802 OTC MONOGRAPH FINAL part338 HyVee Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 42507-837_7981975a-48cd-40ef-81cd-764622736e97 42507-837 HUMAN OTC DRUG pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 19980128 OTC MONOGRAPH FINAL part338 HyVee Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 42507-839_71a44d63-4269-43f4-bb9d-1d7d1fee15ab 42507-839 HUMAN OTC DRUG Childrens mucus relief dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20140303 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 42507-851_ed791dcc-89fe-4525-bc8c-9db0afea992e 42507-851 HUMAN OTC DRUG antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20030210 OTC MONOGRAPH FINAL part332 HyVee Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 42507-852_5a8f65e5-c19f-4ec5-9c6e-ff4c0245f033 42507-852 HUMAN OTC DRUG Ranitidine Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20131202 ANDA ANDA091429 HyVee Inc RANITIDINE HYDROCHLORIDE 150 mg/1 42507-866_59ad8636-8e84-428f-9447-573c2d95b0a6 42507-866 HUMAN OTC DRUG lice treatment Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070826 OTC MONOGRAPH FINAL part358G HyVee Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 42507-872_90c6c58f-8db0-4323-b530-84a03e5d33dd 42507-872 HUMAN OTC DRUG night time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20121008 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 42507-882_efd3e440-5a87-4bd9-aa2b-65407f32800f 42507-882 HUMAN OTC DRUG Infants Gas Relief Simethicone EMULSION ORAL 20080720 OTC MONOGRAPH FINAL part332 HyVee Inc DIMETHICONE 20 mg/.3mL 42507-886_abbe06ff-f0c6-4934-93d9-557805714010 42507-886 HUMAN OTC DRUG sinus Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20071001 OTC MONOGRAPH FINAL part341 HyVee Inc 42507-896_b1e606b0-cfac-4930-85d3-bd6ab42c8b4d 42507-896 HUMAN OTC DRUG Lubricant Eye Polyethylene glycol, Propylene glycol SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130610 OTC MONOGRAPH FINAL part349 HyVee Inc POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 g/100mL; g/100mL 42507-897_00feff66-fe97-4fa3-982c-622d6f137904 42507-897 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION ORAL 19990305 ANDA ANDA074937 HyVee Inc IBUPROFEN 100 mg/5mL 42507-903_d2e53886-5531-41d8-97a5-398aaa1a6718 42507-903 HUMAN OTC DRUG Multi Symptom Cold Plus Childrens Pain Relief Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20080825 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 42507-908_66b07b45-75ba-4f49-9386-ed15a430e9d3 42507-908 HUMAN OTC DRUG Nighttime Cold and Flu acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20060527 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 42507-912_564bae12-347c-41dd-82c5-098c4c84878d 42507-912 HUMAN OTC DRUG daytime nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20060804 OTC MONOGRAPH FINAL part341 HyVee Inc 42507-915_1f268684-d40b-479c-8a95-9757eec3101d 42507-915 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080302 NDA NDA022032 HyVee Inc OMEPRAZOLE 20 mg/1 42507-917_ca1e87f1-9a07-487b-a3bb-cc94045dffde 42507-917 HUMAN OTC DRUG pain relief extra strength Acetaminophen CAPSULE, COATED ORAL 20110314 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 500 mg/1 42507-922_3380360c-0c07-4ca9-8681-aca6fe0f5ac8 42507-922 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130805 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 42507-944_b867f691-7a13-4659-b664-06aa36899310 42507-944 HUMAN OTC DRUG Hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20080811 OTC MONOGRAPH FINAL part346 HyVee Inc GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g 42507-946_9ea588b4-6308-44b6-a429-c7cef3f83939 42507-946 HUMAN OTC DRUG pain and fever infants Acetaminophen SUSPENSION ORAL 20110831 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL 42507-949_51e27f19-f5a5-4a30-a395-4591d8c78e27 42507-949 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide LIQUID ORAL 20050718 OTC MONOGRAPH NOT FINAL part334 HyVee Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 42507-950_f60c0f6a-b29c-4f0c-bb7d-9a0233638ac9 42507-950 HUMAN OTC DRUG acid reducer 150 Ranitidine TABLET, FILM COATED ORAL 20120917 ANDA ANDA091429 HyVee Inc RANITIDINE HYDROCHLORIDE 150 mg/1 42507-955_7d83219d-0def-4527-9713-ff92d40b5975 42507-955 HUMAN OTC DRUG lice treatment Permethrin LOTION TOPICAL 20110122 ANDA ANDA076090 HyVee Inc PERMETHRIN 1 mg/100mL 42507-958_f28232fb-1540-4e70-aaea-64619d3552e9 42507-958 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130708 ANDA ANDA091135 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 42507-959_663c32ed-b11f-48b0-8e17-4cb56da51d33 42507-959 HUMAN OTC DRUG Night Time Sleep Aid Diphenhydramine HCl SOLUTION ORAL 20130708 OTC MONOGRAPH FINAL part338 HyVee Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 42507-966_0c105ab7-25aa-49e9-a8af-d733d6eee4f7 42507-966 HUMAN OTC DRUG arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080720 ANDA ANDA075077 HyVee Inc ACETAMINOPHEN 650 mg/1 42507-975_b38ca35e-cb77-4b10-9a06-517b01e33bb4 42507-975 HUMAN OTC DRUG pain relief Acetaminophen TABLET ORAL 19960528 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 500 mg/1 42507-977_09ed7275-201f-4059-96ed-6cce0223e388 42507-977 HUMAN OTC DRUG night time cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20060611 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 42507-990_5df20ab0-0bde-4ba6-8f72-77060704cbdc 42507-990 HUMAN OTC DRUG Nighttime Cold and Flu acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090914 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 42507-994_a5c697f8-7746-4ce8-a53d-ab471434a6b4 42507-994 HUMAN OTC DRUG day time Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20070121 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 42507-998_8ec19706-ac1b-4a21-bc01-2d0d9006cfdb 42507-998 HUMAN OTC DRUG Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20140205 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 42508-137_a28eba54-866b-432b-833e-6f7e89c4444d 42508-137 HUMAN OTC DRUG Arbonne Revelage Age Spot Brightening Hand Therapy with SPF 30 HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE LOTION TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 80; 75; 50; 30; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 42508-138_9a8aa9b5-3edf-4a41-b315-101c329b6093 42508-138 HUMAN OTC DRUG Arbonne Revelage Age Spot Brightening Day with SPF 30 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100120 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 35; 50; 27.9; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 42508-139_1eeec454-e348-4de8-835c-8df37d0db327 42508-139 HUMAN OTC DRUG RE9 Advanced Restorative Day Creme SPF 20 OCTISALATE, OCTOCRYLENE, and ZINC OXIDE LOTION TOPICAL 20100121 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC OCTISALATE; OCTOCRYLENE; ZINC OXIDE 50; 80; 73.5 mg/mL; mg/mL; mg/mL 42508-145_76a46842-cfa3-40cd-9868-c65b12573577 42508-145 HUMAN OTC DRUG Sheer Finish Tinted Moisturizer Light SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-146_0996d75d-ef53-4083-9e05-622a347bea9d 42508-146 HUMAN OTC DRUG Sheer Finish Tinted Moisturizer Medium SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-147_8a502fed-7439-419f-b24e-f6a9d4abab2e 42508-147 HUMAN OTC DRUG Sheer Finish Tinted Moisturizer Medium-Beige SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-148_6025fe81-b726-4fcd-8298-8a03070628b8 42508-148 HUMAN OTC DRUG Sheer Finish Tinted Moisturizer Fair SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-149_3e59d44c-e88e-4452-81d5-25b827f681ec 42508-149 HUMAN OTC DRUG Sheer Finish Tinted Moisturizer Dark SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-150_5dba606d-c7cd-4617-82bf-569ba8bf4561 42508-150 HUMAN OTC DRUG Sheer Finish Tinted Moisturizer Warm Beige SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-151_8a5469ab-4b88-43cc-aedf-511779bbc658 42508-151 HUMAN OTC DRUG Perfecting Liquid Foundation Deep Bronze SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-152_fb7b478c-1475-41d2-a0c8-38cf8cb1405e 42508-152 HUMAN OTC DRUG Perfecting Liquid Foundation Earthy Beige SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-153_67a23c07-5cf5-4c77-b306-4c30b9db2f87 42508-153 HUMAN OTC DRUG Perfecting Liquid Foundation Alabaster SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-154_d66d5f62-5ac6-4587-b0dd-2658ea61410d 42508-154 HUMAN OTC DRUG Perfecting Liquid Foundation Fair SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-155_b220f212-cac3-4945-b0c1-6eeaaab7a5ec 42508-155 HUMAN OTC DRUG Perfecting Liquid Foundation Golden Beige SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-156_2d542663-78dd-4395-ad62-db68b92598f5 42508-156 HUMAN OTC DRUG Perfecting Liquid Foundation Golden Bronze SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-157_60df49f1-baf8-4d33-b5a2-50ca5dc0ad8a 42508-157 HUMAN OTC DRUG Perfecting Liquid Foundation Honey Beige SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-158_511da9b5-8018-4162-9f3c-db09281293d6 42508-158 HUMAN OTC DRUG Perfecting Liquid Foundation Rosy Beige SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-159_cee244fa-f0c4-4243-bdfc-4f54335fa3eb 42508-159 HUMAN OTC DRUG Perfecting Liquid Foundation Neutral Beige SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-160_3267a8b9-6c99-41f1-a206-f6c3d90da2a5 42508-160 HUMAN OTC DRUG Perfecting Liquid Foundation Soft Blush SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-161_e8874d5b-8a33-40e9-9e40-c6f580df16ce 42508-161 HUMAN OTC DRUG Perfecting Liquid Foundation Toffee Bronze SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-162_c9aba613-9879-4ab3-acbb-c2e504213e25 42508-162 HUMAN OTC DRUG Perfecting Liquid Foundation Deep Beige SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-163_97825e49-9392-43a5-b4e8-1c5c11d8be4e 42508-163 HUMAN OTC DRUG Perfecting Liquid Foundation Espresso SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-164_11a525b7-875d-4cb5-bae8-187818aadcbb 42508-164 HUMAN OTC DRUG Perfecting Liquid Foundation Porcelain SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-165_e3094f91-110c-41a5-9b2b-c6a38cab04ed 42508-165 HUMAN OTC DRUG Perfecting Liquid Foundation Buff SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL 42508-254_b33923a0-7a5c-4bb1-a5b0-d8515c192851 42508-254 HUMAN OTC DRUG Clear Advantage Clarifying SALICYLIC ACID LOTION TOPICAL 20090306 OTC MONOGRAPH FINAL part333D Arbonne International, LLC SALICYLIC ACID 10 mg/mL 42508-255_3d7b79b6-f30a-4cf5-8d7c-7404e62a6b55 42508-255 HUMAN OTC DRUG Clear Advantage Clarifying Wash SALICYLIC ACID SOLUTION TOPICAL 20090316 OTC MONOGRAPH FINAL part333D Arbonne International, LLC SALICYLIC ACID 10 mg/mL 42508-256_a7a8c8bc-d6df-4e9f-b9ab-3856a014e6b5 42508-256 HUMAN OTC DRUG Arbonne Clear Advantage Toner Salicylic Acid LOTION TOPICAL 20090401 OTC MONOGRAPH FINAL part333D Arbonne International, LLC SALICYLIC ACID 5 mg/mL 42508-263_d599b368-7f3f-4025-bb27-bb05522a4e2d 42508-263 HUMAN OTC DRUG Arbonne Baby Care Sunscreen SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, and ZINC OXIDE CREAM TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 75; 50; 25; 100 mg/mL; mg/mL; mg/mL; mg/mL 42508-265_3acdfdb1-fd03-4cfb-8c36-2c1e880ead57 42508-265 HUMAN OTC DRUG Arbonne RE9 Advanced for Men Facial Moisturizer SPF 20 Octisalate, Octocrylene, and Zinc Oxide LOTION TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC OCTISALATE; OCTOCRYLENE; ZINC OXIDE 50; 80; 73.5 mg/mL; mg/mL; mg/mL 42508-280_192d2bf0-ee5e-46cd-a0cc-bf8b5ac6436f 42508-280 HUMAN OTC DRUG Arbonne Made in the Shade Self Tanner Sunscreen SPF 15 OCTINOXATE, OCTISALATE, and OXYBENZONE LOTION TOPICAL 20110606 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 30 mg/mL; mg/mL; mg/mL 42508-529_389aefae-2d57-440c-934f-7f31a2a9f871 42508-529 HUMAN OTC DRUG ABC Arbonne Baby Care Diaper Rash DIMETHICONE and ZINC OXIDE CREAM TOPICAL 20140920 OTC MONOGRAPH FINAL part347 Arbonne International, LLC DIMETHICONE; ZINC OXIDE 1; 12 g/100g; g/100g 42508-532_e2f3e694-f302-4ed3-b2f0-43a2837d93da 42508-532 HUMAN OTC DRUG ABC Arbonne Baby Care Sunscreen Broad Spectrum SPF 30 ZINC OXIDE LOTION TOPICAL 20140920 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 144 mg/mL 42515-001_fc93d705-9343-4856-a72d-bebdb4ffed46 42515-001 VACCINE IXIARO Japanese Encephalitis Vaccine, Inactivated, Adsorbed INJECTION, SUSPENSION INTRAMUSCULAR 20090330 BLA BLA125280 Intercell Biomedical LTD JAPANESE ENCEPHALITIS VIRUS STRAIN NAKAYAMA-NIH ANTIGEN (FORMALDEHYDE INACTIVATED) 6 ug/.5mL Inactivated Japanese Encephalitis Virus Vaccine [EPC],Actively Acquired Immunity [PE],Japanese Encephalitis Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 42536-6044_35a018ba-f817-4f46-81e2-d8e2a5319d48 42536-6044 HUMAN PRESCRIPTION DRUG PYtest Urea, C-14 CAPSULE ORAL 19970509 NDA NDA020617 Avent, Inc. UREA, C-14 1 uCi/1 42536-6046_ed333311-0729-4d5e-86d6-1d3dcd72896d 42536-6046 HUMAN PRESCRIPTION DRUG PYtest Urea, C-14 CAPSULE ORAL 19970509 NDA NDA020617 Avent, Inc. UREA, C-14 1 uCi/1 42537-024_ff290e74-535d-49cb-9c29-84fcc4f1bfad 42537-024 HUMAN OTC DRUG Qore 24 Antimicrobial Hand Purifier BENZALKONIUM CHLORIDE SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part333E Qore Systems LLC BENZALKONIUM CHLORIDE 10 mg/100mL 42543-052_0ae8561a-5182-405c-9b1e-f0a18b9b04b1 42543-052 HUMAN PRESCRIPTION DRUG Nystatin Nystatin POWDER TOPICAL 20140901 ANDA ANDA065175 Vensun Pharmaceuticals, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 42543-700_55eb9d6b-85c2-47cb-8460-4434c3fddb30 42543-700 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20140731 ANDA ANDA203374 Vensun Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 42543-702_d42c5c43-d7e6-4419-af1a-f09162eaaf2b 42543-702 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20141210 ANDA ANDA203907 Vensun Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 42543-703_d42c5c43-d7e6-4419-af1a-f09162eaaf2b 42543-703 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20141210 ANDA ANDA203907 Vensun Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 42543-710_e4451936-bd51-4796-94d6-df8badd3cf27 42543-710 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20141018 ANDA ANDA203018 Vensun Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42543-711_e4451936-bd51-4796-94d6-df8badd3cf27 42543-711 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20141018 ANDA ANDA203018 Vensun Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 42543-712_79092680-6f26-41a9-9ca0-984b5c8eb49e 42543-712 HUMAN PRESCRIPTION DRUG levocetirizine dihydrochloride levocetirizine dihydrochloride TABLET ORAL 20141027 ANDA ANDA203646 Vensun Pharmaceuticals, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 42543-713_fa78fbf5-aa8f-437d-bfd6-8d6629f49a7b 42543-713 HUMAN PRESCRIPTION DRUG Clopidogrel clopidogrel TABLET ORAL 20141101 ANDA ANDA204165 Vensun Pharmaceuticals, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 42543-714_fa78fbf5-aa8f-437d-bfd6-8d6629f49a7b 42543-714 HUMAN PRESCRIPTION DRUG Clopidogrel clopidogrel TABLET ORAL 20141101 ANDA ANDA204165 Vensun Pharmaceuticals, Inc. CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 42545-000_52401753-de02-46f5-bc2d-cdb34b963554 42545-000 HUMAN PRESCRIPTION DRUG OXYGEN, REFRIGERATED OXYGEN GAS RESPIRATORY (INHALATION) 20121128 UNAPPROVED MEDICAL GAS Dona Ana Medical Supply DBA Silver City Medical Supply OXYGEN 1 L/L 42546-010_2c0e16ae-678d-4a1b-84c8-007ddf32ac1b 42546-010 HUMAN PRESCRIPTION DRUG BenzePrO Benzoyl Peroxide AEROSOL, FOAM TOPICAL 20120701 OTC MONOGRAPH FINAL part333D PruGen, Inc. BENZOYL PEROXIDE 3.18 g/60g 42546-015_b8493f70-4536-421a-96e5-b1e65590f10c 42546-015 HUMAN PRESCRIPTION DRUG BenzePrO Benzoyl Peroxide AEROSOL, FOAM TOPICAL 20120701 OTC MONOGRAPH FINAL part333D PruGen, Inc. BENZOYL PEROXIDE 9.8 g/100g 42546-100_2267e100-a474-4423-8f46-3458a9e5e221 42546-100 HUMAN PRESCRIPTION DRUG CEM-Urea urea SOLUTION TOPICAL 20110701 UNAPPROVED DRUG OTHER PruGen, Inc. UREA .45 mL/mL 42546-145_e05fd63e-8770-4c4d-adfa-b4c76171deb2 42546-145 HUMAN PRESCRIPTION DRUG PR Benzoyl Peroxide Wash Benzoyl Peroxide Wash LOTION TOPICAL 20091026 UNAPPROVED DRUG OTHER PruGen, Inc. BENZOYL PEROXIDE 70 mg/mL 42546-175_1bf851d1-3ed5-4a61-abaf-2a2100d7857e 42546-175 HUMAN PRESCRIPTION DRUG SulfaCleanse 8/4 sodium sulfacetamide and sulfur LOTION TOPICAL 20110501 UNAPPROVED DRUG OTHER PruGen, Inc. SULFACETAMIDE SODIUM; SULFUR 80; 40 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42546-180_6c9669f5-7c92-4af0-966a-f4f825fe89ab 42546-180 HUMAN PRESCRIPTION DRUG Bal-Care DHA BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, SODIUM FEREDETATE, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, IRON SUCROSE, IODINE, OMEGA 3 FATTY ACIDS KIT 20120501 UNAPPROVED DRUG OTHER PruGen, Inc. 42546-185_2c323451-ca19-4f26-aa1f-c281f53bc8e4 42546-185 HUMAN PRESCRIPTION DRUG Bal-Care DHA Essential BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, SODIUM FEREDETATE, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, IRON SUCROSE, IODINE, OMEGA 3 FATTY ACIDS KIT 20120501 UNAPPROVED DRUG OTHER PruGen, Inc. 42546-190_1ace1b62-3565-4486-ac54-94a2a1b74554 42546-190 HUMAN PRESCRIPTION DRUG Moms Choice Rx BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, SODIUM FEREDETATE, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, IRON SUCROSE, IODINE, OMEGA 3 FATTY ACIDS KIT 20130401 UNAPPROVED DRUG OTHER PruGen, Inc. 42546-270_f746bae8-eac3-4134-aac2-95c9e7c790f1 42546-270 HUMAN PRESCRIPTION DRUG Salicylic Acid salicylic acid CREAM TOPICAL 20110501 UNAPPROVED DRUG OTHER PruGen, Inc. SALICYLIC ACID 27.24 g/g 42546-279_03a08f13-3bcd-4e6a-b890-a3d1f38aac40 42546-279 HUMAN PRESCRIPTION DRUG Salicylic Acid 6 percent Salicylic Acid SHAMPOO TOPICAL 20090101 UNAPPROVED DRUG OTHER PruGen, Inc. SALICYLIC ACID 6 mg/100mL 42546-300_3a11164d-6eb1-4a01-8722-0086f94a85b3 42546-300 HUMAN PRESCRIPTION DRUG Zingiber pyridoxine, folic acid, calcium, and ginger tablet TABLET ORAL 20130201 UNAPPROVED DRUG OTHER PruGen, Inc. Pharmaceuticals CALCIUM; FOLIC ACID; GINGER; PYRIDOXINE 124.1; 1.2; 100; 40 mg/1; mg/1; mg/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 42546-517_00736fdd-192f-4ef9-9abe-c5c0d2f8cef2 42546-517 HUMAN PRESCRIPTION DRUG PR Natal 400 ec beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron protein succinylate, ferrous bisglycinate, magnesium oxide, zinc oxide, cupric oxide tablet KIT 20100101 UNAPPROVED DRUG OTHER PruGen, Inc Pharmaceuticals 42546-518_9e43a416-3601-44e3-be7f-9132594aedaa 42546-518 HUMAN PRESCRIPTION DRUG PR Natal 430 ec beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron protein succinylate, ferrous bisglycinate, magnesium oxide, zinc oxide, cupric oxide tablet KIT 20100101 UNAPPROVED DRUG OTHER PruGen, Inc Pharmaceuticals 42546-811_41935853-a3f1-42ff-8ce8-8d34257d8d87 42546-811 HUMAN PRESCRIPTION DRUG PR Natal 400 beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron protein succinylate, ferrous bisglycinate, magnesium oxide, zinc oxide, cupric oxide tablet KIT 20100101 UNAPPROVED DRUG OTHER PruGen, Inc Pharmaceuticals 42546-812_38df8e18-1046-48cf-9965-2d574e3269e3 42546-812 HUMAN PRESCRIPTION DRUG PR Natal 430 beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron protein succinylate, ferrous bisglycinate, magnesium oxide, zinc oxide, cupric oxide tablet KIT 20100101 UNAPPROVED DRUG OTHER PruGen, Inc Pharmaceuticals 42549-492_18e3c315-ee0b-40cc-bab3-c3c3b03ab243 42549-492 HUMAN PRESCRIPTION DRUG DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE ORAL 19871109 ANDA ANDA071669 STAT Rx USA LLC DOXEPIN HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 42549-495_c1f9018a-919a-4aa1-990b-b144bb496178 42549-495 HUMAN PRESCRIPTION DRUG BUTALBITAL AND ACETAMINOPHEN BUTALBITAL AND ACETAMINOPHEN TABLET ORAL 19941201 ANDA ANDA089988 STAT Rx USA LLC ACETAMINOPHEN; BUTALBITAL 650; 50 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] 42549-496_89e9b863-3650-4b7a-bdd1-60a5aac881c5 42549-496 HUMAN PRESCRIPTION DRUG WARFARIN SODIUM WARFARIN SODIUM TABLET ORAL 20111104 ANDA ANDA040145 STAT Rx USA LLC WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 42549-497_89e9b863-3650-4b7a-bdd1-60a5aac881c5 42549-497 HUMAN PRESCRIPTION DRUG WARFARIN SODIUM WARFARIN SODIUM TABLET ORAL 20111104 ANDA ANDA040145 STAT Rx USA LLC WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 42549-498_7a1cc088-a960-4cca-b2d8-fdc34aef6c49 42549-498 HUMAN PRESCRIPTION DRUG GLIMEPIRIDE GLIMEPIRIDE TABLET ORAL 20051006 ANDA ANDA077091 STAT Rx USA LLC GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 42549-499_f6e79562-95ee-4a20-8bdd-0e597cbf3e19 42549-499 HUMAN PRESCRIPTION DRUG GLIMEPIRIDE GLIMEPIRIDE TABLET ORAL 20051006 ANDA ANDA077295 STAT Rx USA LLC GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 42549-500_4845f257-8902-42e1-8e9e-de463f2e5ae6 42549-500 HUMAN PRESCRIPTION DRUG ALLOPURINOL ALLOPURINOL TABLET ORAL 20030627 ANDA ANDA075798 STAT Rx USA LLC ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 42549-503_c5bdea83-11b5-44d8-a8b6-d4d8efbc141b 42549-503 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 19960124 ANDA ANDA040124 STAT Rx USA LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 42549-504_07eb04af-de5c-455a-8121-950594ada521 42549-504 HUMAN PRESCRIPTION DRUG CEFADROXIL CEFADROXIL CAPSULE ORAL 20070125 ANDA ANDA065352 STAT Rx USA LLC CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42549-505_9f33c97f-450c-4e52-9924-cbb492cda978 42549-505 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 19981002 NDA NDA020998 STAT Rx USA LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-508_3f8e54fa-ba74-4761-8cca-6785f2faf040 42549-508 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20100429 ANDA ANDA074436 STAT Rx USA LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 42549-510_03d92786-7d66-4220-931f-8066f2b15132 42549-510 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 20100305 ANDA ANDA075281 STAT Rx USA LLC DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-511_53da42f4-eedb-424b-bf3c-5cce6639fbe2 42549-511 HUMAN PRESCRIPTION DRUG ETODOLAC ETODOLAC TABLET, FILM COATED ORAL 20030501 ANDA ANDA076004 STAT Rx USA LLC ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-512_75574cc2-32c4-4501-99ad-1d7ad1ae5923 42549-512 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 STAT Rx USA LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42549-513_75574cc2-32c4-4501-99ad-1d7ad1ae5923 42549-513 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 STAT Rx USA LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42549-514_fe5ba386-ea2e-4884-9ce7-f00f71d4c101 42549-514 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040400 STAT Rx USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42549-516_fe5ba386-ea2e-4884-9ce7-f00f71d4c101 42549-516 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040201 STAT Rx USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42549-517_18d6cb05-eb82-4b32-8fb7-ab884ca67d93 42549-517 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20091123 ANDA ANDA078558 STAT Rx USA LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-518_18d6cb05-eb82-4b32-8fb7-ab884ca67d93 42549-518 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20091123 ANDA ANDA078558 STAT Rx USA LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-519_e9087460-4450-4f89-a66e-64cb1f3fdda9 42549-519 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20091005 ANDA ANDA077937 STAT Rx USA LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-521_e6193937-d54a-4741-aaf6-d4a5dbca1980 42549-521 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19871101 ANDA ANDA084276 STAT Rx USA LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 42549-522_9fb963bc-3f62-4bcc-8f46-37015b18d917 42549-522 HUMAN PRESCRIPTION DRUG METHYLPREDNISOLONE METHYLPREDNISOLONE TABLET ORAL 19971031 ANDA ANDA040189 STAT Rx USA LLC METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 42549-523_1fc55b88-c632-46c7-b13f-38c723b5f462 42549-523 HUMAN PRESCRIPTION DRUG NABUMETONE NABUMETONE TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 STAT Rx USA LLC NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-525_3c31b980-35e8-4cca-b7f3-2c09fd7d70d5 42549-525 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20040114 ANDA ANDA076494 STAT Rx USA LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-527_8205b1e1-b70e-4ca7-b8e6-716e91778bc7 42549-527 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20091123 ANDA ANDA076003 STAT Rx USA LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 42549-528_8836044c-c345-4030-9eaa-5c20f5373228 42549-528 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 19960715 ANDA ANDA040156 STAT Rx USA LLC HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 42549-529_cdd89c10-f1e3-4f79-ba69-c4d00f91f2d4 42549-529 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 STAT Rx USA LLC AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 42549-531_99e89725-4f27-4487-87e9-c90d19b0fe22 42549-531 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20111116 ANDA ANDA065101 STAT Rx USA LLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 42549-532_e5c9261e-0226-4200-ad8e-479f5b4f9a30 42549-532 HUMAN PRESCRIPTION DRUG CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE ORAL 20010202 ANDA ANDA065061 STAT Rx USA LLC CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 42549-534_8c0d881e-7de7-4167-b3dc-7f921f482427 42549-534 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20060628 ANDA ANDA077856 STAT Rx USA LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42549-535_4a412926-52a9-421a-acc2-617cc5750ba9 42549-535 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 STAT Rx USA LLC ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 42549-537_89392696-0d93-457e-8f17-8e99e7dd58d1 42549-537 HUMAN PRESCRIPTION DRUG GABAPENTIN Gabapentin TABLET ORAL 20090609 ANDA ANDA076017 STAT Rx USA LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42549-538_4f31d34a-f05e-414f-8902-170f872112c1 42549-538 HUMAN PRESCRIPTION DRUG KETOTOLAC TROMETHAMINE KETOTOLAC TROMETHAMINE TABLET, FILM COATED ORAL 20100915 ANDA ANDA074761 STAT Rx USA LLC KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-541_6ff42682-5cbe-4f34-9078-4c884f447339 42549-541 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20100429 ANDA ANDA076048 STAT Rx USA LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 42549-542_cdd335d1-f223-44b2-95a4-98363f7a8cf3 42549-542 HUMAN PRESCRIPTION DRUG PIROXICAM PIROXICAM CAPSULE ORAL 20111007 ANDA ANDA074131 STAT Rx USA LLC PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-543_7ce00bde-a52e-498e-bb55-5d2a09dce084 42549-543 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 19730919 ANDA ANDA083426 STAT Rx USA LLC PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 42549-546_0baed76a-de60-4488-b47f-61c66547f824 42549-546 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071258 STAT Rx USA LLC TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 42549-548_4138a333-8c31-4ec2-a553-3dae90076473 42549-548 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 STAT Rx USA LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 42549-549_2a493f6b-be4a-41d2-9ad9-82f440b0dd83 42549-549 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride TABLET ORAL 20021126 ANDA ANDA076280 STAT Rx USA LLC TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 42549-553_4143ce9b-e1a9-4840-ba49-1503bc6db8b8 42549-553 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 19950612 ANDA ANDA089718 STAT Rx USA LLC ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 42549-554_82e2202d-47df-4986-b4db-90f4373204bb 42549-554 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20091120 ANDA ANDA070325 STAT Rx USA LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42549-556_fe5ba386-ea2e-4884-9ce7-f00f71d4c101 42549-556 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040409 STAT Rx USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42549-557_fe5ba386-ea2e-4884-9ce7-f00f71d4c101 42549-557 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040405 STAT Rx USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42549-558_ddaaed5f-3470-4d3a-9b84-69ff9267218f 42549-558 HUMAN PRESCRIPTION DRUG LORAZEPAM LORAZEPAM TABLET ORAL 19911031 ANDA ANDA072928 STAT Rx USA LLC LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42549-559_8f8a7b74-b0b3-4f1e-968a-6dc29c1bc859 42549-559 HUMAN PRESCRIPTION DRUG ORPHENADRINE CITRATE ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE ORAL 20000623 ANDA ANDA040368 STAT Rx USA LLC ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 42549-560_801c42af-6942-4b43-b96d-eadf4cb5fb92 42549-560 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 19981217 ANDA ANDA075208 STAT Rx USA LLC RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 42549-561_8f06aa22-4990-4657-8db4-5b77963478a7 42549-561 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20100524 ANDA ANDA070920 STAT Rx USA LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42549-565_9c638795-d3d2-4d67-a9fd-420782a1432a 42549-565 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110128 ANDA ANDA062702 STAT Rx USA LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 42549-566_d1ac3d0c-72b2-4108-ba49-cda456039415 42549-566 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070801 ANDA ANDA078314 STAT Rx USA LLC NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-569_578e6cb3-f31e-40dd-a987-7b1e053632ff 42549-569 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED ORAL 20051216 ANDA ANDA077184 STAT Rx USA LLC ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 42549-570_99e89725-4f27-4487-87e9-c90d19b0fe22 42549-570 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20111116 ANDA ANDA065096 STAT Rx USA LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 42549-572_0d53972c-6fe3-4607-9fcd-c0acffb05565 42549-572 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE EXTENDED-RELEASE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20101021 ANDA ANDA076412 STAT Rx USA LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-573_d3245d50-eae4-4b59-b21f-be31a145ab2f 42549-573 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070820 ANDA ANDA076709 STAT Rx USA LLC FENTANYL 2.5 mg/72h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-574_6108ef1e-ac59-4a0b-bce3-bd07415ac79e 42549-574 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 20070919 ANDA ANDA078273 STAT Rx USA LLC HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-576_41e2a9d3-78d4-4d19-bc10-a934c2109fcd 42549-576 HUMAN PRESCRIPTION DRUG LIDODERM Lidocaine PATCH CUTANEOUS 20100201 NDA NDA020612 STAT Rx USA LLC LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 42549-577_2a48c0a4-6d8e-4b2e-9b75-710a0874b504 42549-577 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20090519 ANDA ANDA040517 STAT Rx USA LLC METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-578_2a48c0a4-6d8e-4b2e-9b75-710a0874b504 42549-578 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20090519 ANDA ANDA040517 STAT Rx USA LLC METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-586_f62826b7-9e54-4869-8246-c23880d5f76b 42549-586 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040769 STAT Rx USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42549-589_03d92786-7d66-4220-931f-8066f2b15132 42549-589 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 20100305 ANDA ANDA075281 STAT Rx USA LLC DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-592_d1ac3d0c-72b2-4108-ba49-cda456039415 42549-592 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 STAT Rx USA LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-594_6108ef1e-ac59-4a0b-bce3-bd07415ac79e 42549-594 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 20070919 ANDA ANDA078273 STAT Rx USA LLC HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-597_2a493f6b-be4a-41d2-9ad9-82f440b0dd83 42549-597 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride TABLET ORAL 20020627 ANDA ANDA076280 STAT Rx USA LLC TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 42549-599_c5f3b825-54df-41fd-9090-868f42f57db4 42549-599 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20120320 ANDA ANDA076001 STAT Rx USA LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42549-602_a737d18f-5fe7-48c6-bbf5-2c2b7a30da62 42549-602 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET ORAL 20080317 NDA NDA022207 STAT Rx USA LLC MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-603_82e2202d-47df-4986-b4db-90f4373204bb 42549-603 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20091120 ANDA ANDA070325 STAT Rx USA LLC DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42549-604_e9087460-4450-4f89-a66e-64cb1f3fdda9 42549-604 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20091005 ANDA ANDA077918 STAT Rx USA LLC MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-605_cdd89c10-f1e3-4f79-ba69-c4d00f91f2d4 42549-605 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085971 STAT Rx USA LLC AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 42549-606_d7294093-bfe0-4d51-bafb-43867ecad2e7 42549-606 HUMAN PRESCRIPTION DRUG Flector Diclofenac epolamine PATCH TOPICAL 20080608 NDA NDA021234 STAT Rx USA LLC DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-608_b5188da2-a8ca-4823-bd11-1803b178c900 42549-608 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20090213 ANDA ANDA074869 STAT Rx USA LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42549-609_fe5ba386-ea2e-4884-9ce7-f00f71d4c101 42549-609 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA089160 STAT Rx USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42549-610_9240decb-fdf9-4324-a381-e5d8b69b12ff 42549-610 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20070319 ANDA ANDA078206 STAT Rx USA LLC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-612_a124a96a-8779-47b9-a96d-ea27173ff8a0 42549-612 HUMAN PRESCRIPTION DRUG LYRICA PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 STAT Rx USA LLC PREGABALIN 75 mg/1 CV 42549-613_cdd89c10-f1e3-4f79-ba69-c4d00f91f2d4 42549-613 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 STAT Rx USA LLC AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 42549-614_0d53972c-6fe3-4607-9fcd-c0acffb05565 42549-614 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE EXTENDED-RELEASE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20101021 ANDA ANDA076412 STAT Rx USA LLC MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-615_6735d026-b782-4d2f-a333-6e0186c1567c 42549-615 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20090401 ANDA ANDA040545 STAT Rx USA LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-618_be86f0be-e054-4a08-87ee-25b9171e5cdf 42549-618 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20080701 ANDA ANDA040778 STAT Rx USA LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-619_7f54335e-6a2d-4647-a44d-fea7b7d27d75 42549-619 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 STAT Rx USA LLC TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42549-620_7f54335e-6a2d-4647-a44d-fea7b7d27d75 42549-620 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 STAT Rx USA LLC TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42549-621_7f54335e-6a2d-4647-a44d-fea7b7d27d75 42549-621 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 STAT Rx USA LLC TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42549-627_87f66d8e-7556-4326-bf57-720f27f7e97e 42549-627 HUMAN PRESCRIPTION DRUG VOLTAREN diclofenac sodium GEL TOPICAL 20071017 NDA NDA022122 STAT Rx USA LLC DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-628_d3245d50-eae4-4b59-b21f-be31a145ab2f 42549-628 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070820 ANDA ANDA076709 STAT Rx USA LLC FENTANYL 5 mg/72h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-640_be86f0be-e054-4a08-87ee-25b9171e5cdf 42549-640 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20080701 ANDA ANDA040778 STAT Rx USA LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-641_3f8e54fa-ba74-4761-8cca-6785f2faf040 42549-641 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20100429 ANDA ANDA071611 STAT Rx USA LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 42549-642_9f33c97f-450c-4e52-9924-cbb492cda978 42549-642 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 19981002 NDA NDA020998 STAT Rx USA LLC CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-643_cdf1f565-d633-4d1e-bf98-4b1375ebe1ec 42549-643 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20070131 ANDA ANDA077712 STAT Rx USA LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-644_cdf1f565-d633-4d1e-bf98-4b1375ebe1ec 42549-644 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20070131 ANDA ANDA077712 STAT Rx USA LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-645_64f885ed-6036-4046-aacf-1f9a16354d18 42549-645 HUMAN PRESCRIPTION DRUG OXYCONTIN OXYCODONE HYDROCHLORIDE TABLET ORAL 20100808 NDA NDA022272 STAT Rx USA LLC OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-646_a2b73ec4-61b5-456e-a155-15c955ef13b8 42549-646 HUMAN PRESCRIPTION DRUG CYMBALTA DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 STAT Rx USA LLC DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42549-647_7bf7cce7-78f5-48bb-92a1-b93481f53f34 42549-647 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 19740226 ANDA ANDA083677 STAT Rx USA LLC PREDNISONE 20 mg/1 42549-648_f99aa76d-07d4-4ede-8151-d281f39f6b90 42549-648 HUMAN PRESCRIPTION DRUG NABUMETONE NABUMETONE TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 STAT Rx USA LLC NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42549-650_6d6298d8-78ac-4d7e-8ddc-d08c7db0594e 42549-650 HUMAN PRESCRIPTION DRUG METAXALONE METAXALONE TABLET ORAL 20071101 NDA NDA013217 STAT Rx USA LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 42549-651_8f06aa22-4990-4657-8db4-5b77963478a7 42549-651 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20100524 ANDA ANDA070920 STAT Rx USA LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42549-652_e6193937-d54a-4741-aaf6-d4a5dbca1980 42549-652 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19871101 ANDA ANDA084277 STAT Rx USA LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 42549-653_5c0b75ec-ff46-4ccc-9b3c-d204a489be9f 42549-653 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19970214 ANDA ANDA040148 STAT Rx USA LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 42549-655_ddaaed5f-3470-4d3a-9b84-69ff9267218f 42549-655 HUMAN PRESCRIPTION DRUG LORAZEPAM LORAZEPAM TABLET ORAL 19911031 ANDA ANDA072927 STAT Rx USA LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 42549-656_e26415ee-f2e0-49ad-bdf6-103fcca8b79a 42549-656 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 20061106 ANDA ANDA077723 STAT Rx USA LLC HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 42549-657_f9b56d49-3ec5-4964-aa67-8158e5ea8ca8 42549-657 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20070625 ANDA ANDA077535 STAT Rx USA LLC ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 42549-658_4d612510-2890-462b-a546-6001310dad5c 42549-658 HUMAN PRESCRIPTION DRUG OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED RELEASE ORAL 20090417 ANDA ANDA078490 STAT Rx USA LLC OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 42549-659_a737d18f-5fe7-48c6-bbf5-2c2b7a30da62 42549-659 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET ORAL 20080317 NDA NDA022207 STAT Rx USA LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42549-660_a124a96a-8779-47b9-a96d-ea27173ff8a0 42549-660 HUMAN PRESCRIPTION DRUG LYRICA PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 STAT Rx USA LLC PREGABALIN 50 mg/1 CV 42549-666_336168fd-9f96-4a82-8db1-92cb52a688ac 42549-666 HUMAN PRESCRIPTION DRUG TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE CAPSULE ORAL 20041220 ANDA ANDA075317 STAT Rx USA LLC TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 42549-672_a9748fec-b092-4a05-b40c-cc775a947615 42549-672 HUMAN PRESCRIPTION DRUG ESCITALOPRAM ESCITALOPRAM TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 STAT Rx USA LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42549-674_18207ce3-0649-4cb1-888f-38a0b96ab69f 42549-674 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 STAT Rx USA LLC QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 42549-678_62fa4926-2e18-45ed-9a4a-d1d846502131 42549-678 HUMAN PRESCRIPTION DRUG MODAFINIL MODAFINIL TABLET ORAL 20120406 NDA AUTHORIZED GENERIC NDA020717 STAT Rx USA LLC MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 42549-680_cb8c6ae6-7fa6-4a12-8375-ead2556c1840 42549-680 HUMAN PRESCRIPTION DRUG PRIMIDONE PRIMIDONE TABLET ORAL 20010524 ANDA ANDA084903 STAT Rx USA LLC PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 42549-693_86642628-4094-4d67-b46d-188b210bb0a8 42549-693 HUMAN OTC DRUG Promolaxin Docusate sodium TABLET ORAL 20110415 OTC MONOGRAPH NOT FINAL part334 STAT Rx USA LLC DOCUSATE SODIUM 100 mg/1 42555-060_b29c9e25-0e88-4988-bafa-3067036c3a36 42555-060 HUMAN OTC DRUG Colgate Anticavity Toothpaste Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20090604 OTC MONOGRAPH FINAL part355 COLGATE-PALMOLIVE (THAILAND) LIMITED SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 42571-005_ec551de0-5b4f-4154-9686-e6a487d46a92 42571-005 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20130613 ANDA ANDA090383 Micro Labs Limited SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42571-010_ec551de0-5b4f-4154-9686-e6a487d46a92 42571-010 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20130613 ANDA ANDA090383 Micro Labs Limited SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42571-020_ec551de0-5b4f-4154-9686-e6a487d46a92 42571-020 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20130613 ANDA ANDA090383 Micro Labs Limited SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42571-040_ec551de0-5b4f-4154-9686-e6a487d46a92 42571-040 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20130613 ANDA ANDA090383 Micro Labs Limited SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42571-080_ec551de0-5b4f-4154-9686-e6a487d46a92 42571-080 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20130613 ANDA ANDA090383 Micro Labs Limited SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 42571-100_f53ca6b3-1177-4876-b930-aeee63ca7970 42571-100 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20130613 ANDA ANDA091220 Micro Labs Limited GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 42571-101_f53ca6b3-1177-4876-b930-aeee63ca7970 42571-101 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20130613 ANDA ANDA091220 Micro Labs Limited GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 42571-102_f53ca6b3-1177-4876-b930-aeee63ca7970 42571-102 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20130613 ANDA ANDA091220 Micro Labs Limited GLIMEPIRIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 42571-103_f53ca6b3-1177-4876-b930-aeee63ca7970 42571-103 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20130613 ANDA ANDA091220 Micro Labs Limited GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 42571-104_f53ca6b3-1177-4876-b930-aeee63ca7970 42571-104 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20130613 ANDA ANDA091220 Micro Labs Limited GLIMEPIRIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 42571-105_f53ca6b3-1177-4876-b930-aeee63ca7970 42571-105 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20130613 ANDA ANDA091220 Micro Labs Limited GLIMEPIRIDE 8 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 42571-110_32118eea-b2ae-4c17-bd16-264f6dd81c54 42571-110 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM losartan potassium TABLET, FILM COATED ORAL 20121206 ANDA ANDA091541 Micro Labs Limited LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 42571-111_32118eea-b2ae-4c17-bd16-264f6dd81c54 42571-111 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM losartan potassium TABLET, FILM COATED ORAL 20121206 ANDA ANDA091541 Micro Labs Limited LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 42571-112_32118eea-b2ae-4c17-bd16-264f6dd81c54 42571-112 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM losartan potassium TABLET, FILM COATED ORAL 20121206 ANDA ANDA091541 Micro Labs Limited LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 42571-119_e3ac2085-f671-4156-b3fc-d819dc2962fa 42571-119 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN Tramadol hydrochloride and Acetaminophen TABLET, FILM COATED ORAL 20121215 ANDA ANDA201952 Micro Labs Limited ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 42571-122_7e17e30e-9f03-4f03-9319-014aafd2e968 42571-122 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride levocetirizine Dihydrochloride TABLET, FILM COATED ORAL 20130930 ANDA ANDA202046 Micro Labs Limited LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 42571-132_1febb14c-cca0-4fed-b6d6-304b6fa7f1e6 42571-132 HUMAN PRESCRIPTION DRUG CROMOLYN SODIUM Cromolyn sodium SOLUTION, CONCENTRATE ORAL 20130504 ANDA ANDA202745 Micro Labs Limited CROMOLYN SODIUM 100 mg/5mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] 42582-100_44838a95-745c-4ee2-8361-e3fd9f3de1de 42582-100 HUMAN PRESCRIPTION DRUG ISOXSUPRINE HYDROCHLORIDE isoxsuprine hydrochloride TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Bi-Coastal Pharmaceutical Corporation ISOXSUPRINE HYDROCHLORIDE 10 mg/1 42582-200_44838a95-745c-4ee2-8361-e3fd9f3de1de 42582-200 HUMAN PRESCRIPTION DRUG ISOXSUPRINE HYDROCHLORIDE isoxsuprine hydrochloride TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Bi-Coastal Pharmaceutical Corporation ISOXSUPRINE HYDROCHLORIDE 20 mg/1 42582-300_6b280638-de5a-41f5-8005-86cb00187c81 42582-300 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride and Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20110504 UNAPPROVED DRUG OTHER Bi-Coastal Pharmaceutical Corporation CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] 42584-1001_8cda7c29-c302-4dbd-a705-814b8fb8b092 42584-1001 HUMAN OTC DRUG HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20120214 OTC MONOGRAPH NOT FINAL part333E HOME DEPOT U.S.A. INC. ALCOHOL 62 mL/100mL 42587-001_7c5132ea-889c-4813-ae70-6411961dad84 42587-001 HUMAN OTC DRUG Frais Hand Sanitizer ALCOHOL GEL TOPICAL 20080515 OTC MONOGRAPH FINAL part333 Frais Luxury Products ALCOHOL 66 g/100g 42589-001_d5802176-70bc-4b92-b6af-631d505553cb 42589-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Med-Tech Repairs Inc OXYGEN 99 L/100L 42593-001_fd722a6c-7461-4256-9d67-0e68e9f11d40 42593-001 HUMAN OTC DRUG Barielle Professional Maximum Strength Fungus Rx Antifungal PRO TOLNAFTATE SOLUTION TOPICAL 20120101 OTC MONOGRAPH FINAL part333C Fisk Industries TOLNAFTATE 1 mL/100mL 42593-002_c0963865-9260-41f4-809b-1c16b0cda4bc 42593-002 HUMAN OTC DRUG Barielle Fungus Rx Maximum Strength Anti-Fungal TOLNAFTATE SOLUTION TOPICAL 20120101 OTC MONOGRAPH FINAL part333C Fisk Industries TOLNAFTATE 1 mL/100mL 42602-001_71ed056b-ad9d-42ad-98b9-9ffeb41c8022 42602-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20080901 NDA NDA205820 Norco, Inc. OXYGEN 999 L/1000L 42602-002_39bd1938-f366-4d32-912e-acb41b6d2423 42602-002 HUMAN PRESCRIPTION DRUG HELIUM HELIUM GAS RESPIRATORY (INHALATION) 20080901 NDA NDA205819 Norco, Inc. HELIUM 99 L/100L 42602-003_0771f6da-e8e3-4a5e-96d3-38deb7cc1fcf 42602-003 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 20080901 NDA NDA206009 Norco, Inc NITROUS OXIDE 99 L/100L 42602-004_99719ba1-5b99-4f1d-92e2-db49178013ee 42602-004 HUMAN PRESCRIPTION DRUG MEDICAL AIR OXYGEN GAS RESPIRATORY (INHALATION) 20080901 NDA NDA205820 Norco, Inc. OXYGEN 23 L/100L 42602-005_0d4993d6-6f39-4ec6-a2c5-70ff435c3ccd 42602-005 HUMAN PRESCRIPTION DRUG NITROGEN NF NITROGEN GAS RESPIRATORY (INHALATION) 20030227 NDA NDA205805 Norco, Inc NITROGEN 999 L/1000L 42602-006_745c7989-2544-486d-8068-8d1eeeb0cf8a 42602-006 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 20080901 NDA NDA205764 Norco, Inc CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 42602-007_84f8e177-0959-4346-9a7c-b7dec7fc4c6e 42602-007 HUMAN PRESCRIPTION DRUG COMPRESSED GAS, N.O.S. OXYGEN, HELIUM GAS RESPIRATORY (INHALATION) 20080901 UNAPPROVED MEDICAL GAS Norco, Inc. HELIUM; OXYGEN 79.6; 20.4 L/100L; L/100L 42602-008_9d9efcb2-5df5-47b7-8bc8-88ff92bb5791 42602-008 HUMAN PRESCRIPTION DRUG COMPRESSED GAS OXIDIZING, N.O.S. OXYGEN, HELIUM GAS RESPIRATORY (INHALATION) 20080901 UNAPPROVED MEDICAL GAS Norco, Inc. HELIUM; OXYGEN 70; 30 L/100L; L/100L 42606-004_499fd880-257d-49d2-972f-68be99d6e5cd 42606-004 CELLULAR THERAPY GINTUIT Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen CELLULAR SHEET TOPICAL 20120315 BLA BLA125400 Organogenesis, Inc BOVINE TYPE I COLLAGEN; FORESKIN FIBROBLAST (NEONATAL); FORESKIN KERATINOCYTE (NEONATAL) /; /; / Allogeneic Cultured Cell Scaffold [EPC],Collagen [Chemical/Ingredient],Allogeneic Cultured Cell Scaffold [EPC],Tissue Scaffolds [Chemical/Ingredient],Cells, Cultured, Allogeneic [Chemical/Ingredient],Fibroblasts [Chemical/Ingredient],Allogeneic Cultured Cell Scaffold [EPC],Tissue Scaffolds [Chemical/Ingredient],Cells, Cultured, Allogeneic [Chemical/Ingredient],Keratinocytes [Chemical/Ingredient] 42627-201_b3c62854-b60d-4811-b424-fdae8652f468 42627-201 HUMAN OTC DRUG Veil Fluid Makeup Porcelain SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL 42627-202_5cfed5a9-ad8c-4e9a-afb6-62c73f691d48 42627-202 HUMAN OTC DRUG Veil Fluid Makeup Ivory SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL 42627-203_434e83e7-e3f6-420e-9a77-91e2f6a6ecac 42627-203 HUMAN OTC DRUG Veil Fluid Makeup Nude SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL 42627-204_4a2f174c-9037-466a-9d22-5a4f587674c3 42627-204 HUMAN OTC DRUG Veil Fluid Makeup Light Beige SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL 42627-205_fb2749ec-dcba-4b50-93df-5e64ae1bbe2f 42627-205 HUMAN OTC DRUG Veil Fluid Makeup Honey SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL 42627-206_6eb3c53c-6dd6-474f-bed2-ee10dccc0b51 42627-206 HUMAN OTC DRUG Veil Fluid Makeup Sand SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL 42627-207_292f19d9-fec3-4572-b84d-012b64526828 42627-207 HUMAN OTC DRUG Veil Fluid Makeup Beige SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL 42627-208_0248458f-9b86-4c14-acb8-ed968eb7db99 42627-208 HUMAN OTC DRUG Veil Fluid Makeup Warm Beige SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL 42627-209_54a2b885-74c4-44b4-aabe-d9d9140e9d3d 42627-209 HUMAN OTC DRUG Veil Fluid Makeup Sable SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL 42627-210_542dc1ee-4aa9-4966-9c9f-6e9c91b5770b 42627-210 HUMAN OTC DRUG Veil Fluid Makeup Chestnut SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL 42627-211_3e2fc228-3c16-45b6-ab42-5971f5f7f210 42627-211 HUMAN OTC DRUG Veil Fluid Makeup Walnut SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL 42627-216_b165f3f9-1740-40c6-b407-36f5098a97ab 42627-216 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Shell SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-217_7089a41f-05c1-4d72-86d1-f85dd32c2200 42627-217 HUMAN OTC DRUG Hourglass Illusion Tinted Moisturizer Ivory SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-218_9d6f34d1-3f42-4ef9-a1af-323f9014078d 42627-218 HUMAN OTC DRUG Hourglass Illusion Tinted Moisturizer Light Beige SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-219_1d4b50f9-3694-46c8-aac1-ed2ab810a9f0 42627-219 HUMAN OTC DRUG Hourglass Illusion Tinted Moisturizer Sand SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-220_37df0a67-4f39-4093-92e3-8be2f8513009 42627-220 HUMAN OTC DRUG Hourglass Illusion Tinted Moisturizer Beige SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-221_a0807bcf-9241-4e47-af93-abd851f5d694 42627-221 HUMAN OTC DRUG Hourglass Illusion Tinted Moisturizer Warm Beige SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-229_fa3754b5-49f4-4f01-a81b-260c5cd20882 42627-229 HUMAN OTC DRUG Veil Mineral Primer SPF 15 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC, DBA Hourglass Cosmetics TITANIUM DIOXIDE; ZINC OXIDE 2.45; 4.2 g/mL; g/mL 42627-254_f36e40df-3d9a-4aa3-819e-5e312c1c2468 42627-254 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Shell SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-255_46a2d8d6-10a5-4be7-b522-c3b8da3dc5b9 42627-255 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Ivory SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-256_42cfaf96-b5bb-4ada-8d88-6aa84e627edf 42627-256 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Light Beige SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-257_cad3be09-a339-46bd-9c9f-3b81a8d2171e 42627-257 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Sand SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-258_7a489451-3de2-4919-8ab0-6f03cca2f7d4 42627-258 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Beige SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-259_1ac7ac91-a840-4cc4-a5b5-75ecaa263b04 42627-259 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Sable SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-260_f16a59bd-8a78-4898-b50b-47859277d17b 42627-260 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Nude SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-261_f8d75360-695f-457f-9c45-76fdde5f2f16 42627-261 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Warm Ivory SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-262_fdad4e8d-de25-4c44-9f56-3c4374b936d7 42627-262 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Vanilla SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-263_f7594803-4010-43c4-879b-7d57c0940228 42627-263 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Honey SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-264_13d44fff-ab65-4dc0-8a5b-c29f952ab1e7 42627-264 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Golden SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42627-265_d1d74c2e-ad1b-46b3-ab12-d9f07a16c028 42627-265 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Golden Tan SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL 42637-803_f490b8eb-5aac-4308-9d5a-f41bb7b197ea 42637-803 HUMAN OTC DRUG Olbas Lozenges Maximun Strength Menthol LOZENGE ORAL 20100405 OTC MONOGRAPH FINAL part341 Jakemans (Confectioners) Limited MENTHOL 10 mg/1 42637-810_9260dc0a-cc65-46e1-b8f4-d959928c7d04 42637-810 HUMAN OTC DRUG Throat and Chest Anise and Menthol Menthol LOZENGE ORAL 20110713 OTC MONOGRAPH FINAL part341 Jakemans (Confectioners) Limited MENTHOL 5 mg/1 42637-813_bf1fdce9-c418-4917-820b-f65776a03c51 42637-813 HUMAN OTC DRUG Throat and Chest Honey Lemon and Menthol Menthol LOZENGE ORAL 20110713 OTC MONOGRAPH FINAL part341 Jakemans (Confectioners) Limited MENTHOL 5 mg/1 42637-819_c3783aee-0021-4f41-9176-ed8a09697263 42637-819 HUMAN OTC DRUG Throat and Chest Berry Menthol Menthol LOZENGE ORAL 20110713 OTC MONOGRAPH FINAL part341 Jakemans (Confectioners) Limited MENTHOL 5 mg/1 42637-820_6e3c8775-6887-4f71-aac1-2ae0811d8d63 42637-820 HUMAN OTC DRUG Throat and Chest Chili and Lime Menthol LOZENGE ORAL 20110713 OTC MONOGRAPH FINAL part341 Jakemans (Confectioners) Limited MENTHOL 5 mg/1 42637-821_1bf021d2-bb0d-4b4d-9b95-7bcbea5ed28f 42637-821 HUMAN OTC DRUG Jakemans Blueberry Menthol LOZENGE ORAL 20140101 OTC MONOGRAPH FINAL part341 Jakemans (Confectioners) Ltd. MENTHOL 5 mg/100mg 42637-822_8989d9b2-1e4a-4b5a-b598-f56312767d7f 42637-822 HUMAN OTC DRUG Jakemans Cherry Menthol LOZENGE ORAL 20131209 OTC MONOGRAPH FINAL part341 Jakemans (Confectioners) Ltd. MENTHOL 5 mg/1 42637-823_94c66b42-0f88-499b-938a-6c6a3c036d4a 42637-823 HUMAN OTC DRUG Jakemans Peppermint Menthol LOZENGE ORAL 20131211 OTC MONOGRAPH FINAL part341 Jakemans (Confectioners) Ltd. MENTHOL 5 mg/1 42638-7663_9a75311e-6f33-4772-878f-d50b2372a21f 42638-7663 HUMAN OTC DRUG NicFix Nicotine LIQUID ORAL 20140109 UNAPPROVED HOMEOPATHIC Nico Worldwide, Inc. CAFFEINE; CITRIC ACID MONOHYDRATE; NICOTINE; PHENYLALANINE; TRYPTOPHAN; TYROSINE 115; 45; 3; 30; 40; 30 mg/60000mg; mg/60000mg; mg/60000mg; mg/60000mg; mg/60000mg; mg/60000mg 42638-7664_620e053b-22c4-422b-b16a-3093e0601f6e 42638-7664 HUMAN OTC DRUG NicFix Plus Nicotine LIQUID ORAL 20140109 UNAPPROVED HOMEOPATHIC Nico Worldwide, Inc. CAFFEINE; CITRIC ACID MONOHYDRATE; NICOTINE; PHENYLALANINE; TYROSINE 75; 45; 3; 30; 30 mg/60000mg; mg/60000mg; mg/60000mg; mg/60000mg; mg/60000mg 42638-7666_f7620aec-84a9-4c2d-aeb3-1a68c05fe615 42638-7666 HUMAN OTC DRUG Mycratine Migraine Relief Mycratine Migraine Relief LIQUID ORAL 20130615 UNAPPROVED HOMEOPATHIC Nico Worldwide, Inc. CAFFEINE; NICOTINE; PHENYLALANINE; TRYPTOPHAN; TYROSINE 85; 6; 20; 40; 30 mg/60mL; [hp_X]/60mL; mg/60mL; mg/60mL; mg/60mL 42643-101_455881bc-4c62-4439-b7dc-ce2a80bb9142 42643-101 HUMAN OTC DRUG BABY DIAPER ZINC OXIDE CREAM TOPICAL 20130101 OTC MONOGRAPH FINAL part347 TELLURIAN ZINC OXIDE 10 g/10g 42654-001_9b89666b-ca39-45fd-91f9-05a0a9ec391e 42654-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19370101 UNAPPROVED MEDICAL GAS Prescription Oxygen Service OXYGEN 99 L/100L 42657-111_d7589450-bec8-4796-bc91-aa096017870e 42657-111 HUMAN OTC DRUG SkinDog Avobenzone,Octocrylene,Oxybenzone,Homosalate,Octisalate LOTION TOPICAL 20120105 OTC MONOGRAPH FINAL part352 SkinDog, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.7; 8.5; 2.8; 2.27; 3.4 g/56.7g; g/56.7g; g/56.7g; g/56.7g; g/56.7g 42669-001_c7a09388-0013-49be-baf4-eb9129d9073e 42669-001 HUMAN OTC DRUG Perfect Purity Advanced Hand Refreshing Aloe ALCOHOL GEL TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333E Davion, Inc ALCOHOL .7 mL/mL 42669-002_5a6c486b-b502-43b1-ae77-91ad68e72e5f 42669-002 HUMAN OTC DRUG Perfect Purity Advanced Hand Sanitizer Refreshing ALCOHOL SOLUTION TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333E Davion, Inc ALCOHOL .7 mL/mL 42669-003_d2d4cdea-0e98-4f69-aee8-9d1809738236 42669-003 HUMAN OTC DRUG Perfect Purity Advanced Hand Sanitizer Refreshing ALCOHOL SOLUTION TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333E Davion, Inc ALCOHOL .7 mL/mL 42669-004_8577b087-48d4-4ab0-8eb9-4c84a6db3138 42669-004 HUMAN OTC DRUG FAIR and SQUARE ANTIBACTERIAL HAND SANITIZER with ALOE VERA ALCOHOL SOLUTION TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333E Davion, Inc ALCOHOL .7 mL/mL 42669-005_77c5be1e-eee3-4be4-8616-f047a0ea439c 42669-005 HUMAN OTC DRUG Fair and Square Antibacterial Hand Sanitizer with Vitamine E ALCOHOL SOLUTION TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333E Davion, Inc ALCOHOL .7 mL/mL 42669-006_bf157be9-8219-4710-b2ab-5bb0d4176fc6 42669-006 HUMAN OTC DRUG Fair and Square Antibacterial with Moisturizer TRICLOSAN SOLUTION TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333E Davion, Inc TRICLOSAN .15 mg/100mL 42669-007_3b3ca492-feec-413d-b1a7-f12c45e2fb20 42669-007 HUMAN OTC DRUG Perfect Purity Antibacterial Gold Triclosan SOLUTION TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333E Davion, Inc TRICLOSAN .1 mg/100mL 42669-008_410d7434-ef9d-4716-8494-c503a7faf606 42669-008 HUMAN OTC DRUG Fair and Square Antibacterial with Moisturizers BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333E Davion, Inc BENZALKONIUM CHLORIDE 1.3 g/1000mL 42669-111_01a781e8-79a9-4002-91b0-07744d9fb261 42669-111 HUMAN OTC DRUG Oatmeal Daily Moisturizing Dimethicone LOTION TOPICAL 20140331 OTC MONOGRAPH FINAL part347 Davion, Inc DIMETHICONE 13 mg/g 42669-200_089faa55-cdf4-2775-e054-00144ff8d46c 42669-200 HUMAN OTC DRUG Perfect Purity Medicated Body Powder menthol and zinc oxide POWDER TOPICAL 20100706 OTC MONOGRAPH FINAL part347 Davion, Inc. MENTHOL; ZINC OXIDE .15; 1 g/100g; g/100g 42669-201_089faa55-cdff-2775-e054-00144ff8d46c 42669-201 HUMAN OTC DRUG Perfect Purity Medicated Foot Powder menthol POWDER TOPICAL 20101015 OTC MONOGRAPH NOT FINAL part348 Davion, Inc. MENTHOL 1 g/100g 42669-203_089faa55-ce0a-2775-e054-00144ff8d46c 42669-203 HUMAN OTC DRUG Premier Value Medicated Body Powder menthol and zinc oxide POWDER TOPICAL 20091229 OTC MONOGRAPH FINAL part347 Davion, Inc. MENTHOL; ZINC OXIDE .15; 1 g/100g; g/100g 42669-204_089faa55-ce15-2775-e054-00144ff8d46c 42669-204 HUMAN OTC DRUG Premier Value Medicated Foot Powder menthol POWDER TOPICAL 20140505 OTC MONOGRAPH NOT FINAL part348 Davion, Inc. MENTHOL 1 g/100g 42669-998_f4e4d450-27e5-4329-93cc-a971a6e937cd 42669-998 HUMAN OTC DRUG Perfect Purity HotIce Menthol GEL TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part348 Davion, Inc dba HABA MENTHOL 1 g/100g 42669-999_9f75fc66-14d4-4648-ab19-41f2834c930c 42669-999 HUMAN OTC DRUG Perfect Purity Vaporizing Chest Rub Menthol, Camphor, Eucalyptus Oil OINTMENT TOPICAL 20131219 OTC MONOGRAPH NOT FINAL part348 Davion, Inc dba HABA CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.7; 1; 1 g/100g; g/100g; g/100g 42673-001_d7f23b9a-1fbd-49c5-8a7a-3af0b10ca018 42673-001 HUMAN OTC DRUG Epionce Ultra Shield Zinc Oxide, Homosalate, Octisalate LOTION TOPICAL 20090406 OTC MONOGRAPH FINAL part352 Episciences, Inc. HOMOSALATE; OCTISALATE; ZINC OXIDE .1; .05; .101 mL/mL; mL/mL; mL/mL 42673-002_2bbee12e-dc3a-4046-a4dd-e506f05fc21b 42673-002 HUMAN PRESCRIPTION DRUG Epionce Active Shield SPF 30 Homosalate, Zinc Oxide, Octisalate LOTION TOPICAL 20050324 OTC MONOGRAPH FINAL part352 Episciences, Inc. HOMOSALATE; OCTISALATE; ZINC OXIDE .1; .05; .92 mL/mL; mL/mL; mL/mL 42681-0508_ce166658-4d7e-4b32-9467-8fcf6742c706 42681-0508 HUMAN OTC DRUG Arnica Montana ARNICA MONTANA PELLET SUBLINGUAL 20111123 UNAPPROVED HOMEOPATHIC Whole Foods Market ARNICA MONTANA 30 [hp_C]/1 42681-0512_50d56f7c-05f8-440e-b64f-9f0517b3d06e 42681-0512 HUMAN OTC DRUG 365 Everyday Value Arnica ARNICA MONTANA GEL TOPICAL 20080901 UNAPPROVED HOMEOPATHIC WFM Private Label, LP ARNICA MONTANA 1 [hp_X]/1 42681-9032_4c11f3df-d8d0-4bcf-b2e7-088e17219311 42681-9032 HUMAN OTC DRUG 365 Everyday Value Be Well Cough Ease ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, PROTORTONIA CACTI, DROSERA ROTUNDIFOLIA, IPECAC, PULSATILLA VULGARIS, RUMEX CRISPUS ROOT, PONGIA OFFICINALIS SKELETON, ROASTED, LOBARIA PULMONARIA SYRUP ORAL 20110103 UNAPPROVED HOMEOPATHIC WFM Private Label, LP ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; IPECAC; LOBARIA PULMONARIA; PROTORTONIA CACTI; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 3; 3; 3; 3; 3; 6; 6; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 42681-9033_042bc280-9e43-45ed-8901-270cee98e4c2 42681-9033 HUMAN OTC DRUG 365 Everyday Value Be Well Cough Ease for Kids ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, PROTORTONIA CACTI, DROSERA ROTUNDIFOLIA, IPECAC, PULSATILLA VULGARIS, RUMEX CRISPUS ROOT, PONGIA OFFICINALIS SKELETON, ROASTED, LOBARIA PULMONARIA SYRUP ORAL 20110103 UNAPPROVED HOMEOPATHIC WFM Private Label, LP ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; IPECAC; LOBARIA PULMONARIA; PROTORTONIA CACTI; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 3; 3; 3; 3; 3; 6; 6; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 42702-102_ff4531e8-5933-4524-bf23-fb7a5e0fc2f5 42702-102 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride phenylephrine hydrochloride SOLUTION/ DROPS OPHTHALMIC 20130415 NDA NDA203510 Paragon BioTeck, Inc. PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 42702-103_ff4531e8-5933-4524-bf23-fb7a5e0fc2f5 42702-103 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride phenylephrine hydrochloride SOLUTION/ DROPS OPHTHALMIC 20130415 NDA NDA203510 Paragon BioTeck, Inc. PHENYLEPHRINE HYDROCHLORIDE 100 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 42707-1001_daca2668-d76f-4e0f-b7da-3224ffffdbae 42707-1001 HUMAN OTC DRUG Dangsim K-7 MOMORDICA CHARANTIA FRUIT GRANULE ORAL 20120207 UNAPPROVED DRUG OTHER Korea Genetic Pharm Co., Ltd MOMORDICA CHARANTIA FRUIT 13 g/100g 42707-2001_31876fea-b452-41c1-8723-2db49e9cee82 42707-2001 HUMAN OTC DRUG Energain TRIBULUS TERRESTRIS ROOT GRANULE ORAL 20120207 UNAPPROVED DRUG OTHER Korea Genetic Pharm Co., Ltd TRIBULUS TERRESTRIS ROOT 8 g/100g 42707-3001_98176a68-19cf-4762-806f-fdc2d8e5ee04 42707-3001 HUMAN OTC DRUG Ginseng Khan PANAX GINSENG FRUIT LIQUID ORAL 20120215 UNAPPROVED DRUG OTHER Korea Genetic Pharm Co., Ltd PANAX GINSENG FRUIT 90 mL/100mL 42715-001_7a3e12de-1241-4a9a-8a95-698aaf870604 42715-001 HUMAN OTC DRUG Emerald Green Neutral pH Anti-Bacterial Hand CHLOROXYLENOL SOAP TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E Walter E. Nelson Co. CHLOROXYLENOL .4 mL/100mL 42715-002_ed033436-1145-4b3d-9e4f-7679739ac475 42715-002 HUMAN OTC DRUG CLEAR AND CLEAN Neutral pH Antiseptic Hand Wash CHLOROXYLENOL LIQUID TOPICAL 20130221 OTC MONOGRAPH FINAL part333E Walter E. Nelson Co. CHLOROXYLENOL 4 mg/mL 42716-001_5293f355-490d-4672-9246-fd8e14b7f10f 42716-001 HUMAN OTC DRUG INCHCO Brand SANI-DERM Antiseptic Hand Wash CHLOROXYLENOL SOAP TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E Inland Supply Co., Inc. CHLOROXYLENOL 4 mg/mL 42719-345_aa25aefc-ee31-470e-b94e-742a6e37aa50 42719-345 HUMAN OTC DRUG Stay Clean Foam Hand Sanitizer Hand Sanitizer LIQUID TOPICAL 20090918 OTC MONOGRAPH NOT FINAL part333 Byotrol, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 42719-346_ca36ae2a-21c1-46a3-96cc-de95950d92ae 42719-346 HUMAN OTC DRUG Byotrol Antibacterial Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130308 OTC MONOGRAPH NOT FINAL part333A Byotrol, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL 42719-347_390ab5f1-e771-4d12-8f2a-8271a50f8403 42719-347 HUMAN OTC DRUG WSNA Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140122 OTC MONOGRAPH NOT FINAL part333A Byotrol, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL 42721-112_1ca417b7-a218-4ee2-8866-8f89eabc43a7 42721-112 HUMAN PRESCRIPTION DRUG Monsels solution Ferric Sub Sulfate 20% LIQUID TOPICAL 20140826 UNAPPROVED DRUG OTHER BIODIAGNOSTIC INTERNATIONAL FERRIC SUBSULFATE 20 g/100g Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 42731-002_774be21f-b325-4a3a-8714-87b92dcc94b1 42731-002 HUMAN OTC DRUG Triple Allergy Defense Allium cepa, Amrbosia artemisiifolia, Arsenicum album, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Lemna minor, Linum usitatissimum, Luffa operculata, Natrum muriaticum, Polyporus pinicola, Sabadilla LIQUID ORAL 20130308 UNAPPROVED HOMEOPATHIC Nenningers Naturals, LLC ALLIUM CEPA WHOLE; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; FLAX SEED; FOMITOPSIS PINICOLA FRUITING BODY; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LEMNA MINOR; LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL 42731-012_eaba740c-976b-4973-8823-dde0ec69ac90 42731-012 HUMAN OTC DRUG Triple Flu Defense Alianthus, Ana barbariae, Arsenicum album, Byronia, Eucalyptus, Eupatorium perfoliatum, Gelsemium, Glycerinum, Influenzinum, Mercurius vivus, Phytolacca, Sticta pulmonaria LIQUID ORAL 20121127 UNAPPROVED HOMEOPATHIC Nenningers Naturals, LLC AILANTHUS ALTISSIMA FLOWERING TWIG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GLYCERIN; INFLUENZA A VIRUS A/NEW CALEDONIA/20/99 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/PANAMA/2007/99 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/HONG KONG/330/2001 ANTIGEN (PROPIOLACTONE INACTIVATED); LOBARIA PULMONARIA; MERCURY; PHYTOLACCA AMERICANA ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL 42734-011_19a8c0b2-5514-4984-99ef-c3b7c4ff79d4 42734-011 HUMAN OTC DRUG Pro Hands Antiseptic Hand CHLOROXYLENOL SOAP TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E Discovery Products Corporation CHLOROXYLENOL .6 mL/100mL 42738-210_8290701f-02ef-41c1-94aa-5767d65e66a2 42738-210 HUMAN OTC DRUG BZK Cleansing Benzalkonium Chloride SWAB TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333A Family Hospitality LLC BENZALKONIUM CHLORIDE 1 mL/750mL 42743-4700_605ebeb6-c4ad-4c3e-8a6d-e15b63041dda 42743-4700 HUMAN OTC DRUG American Crew Anti-Dandruff plus Sebum Control Pyrithione Zinc SHAMPOO CUTANEOUS 20130831 OTC MONOGRAPH FINAL part358H Colomer USA, Ltd. PYRITHIONE ZINC 10 mg/mL 42747-221_d07bb89b-1d6e-43a0-839d-d85a8f0619c5 42747-221 HUMAN PRESCRIPTION DRUG Abstral fentanyl TABLET SUBLINGUAL 20110107 NDA NDA022510 ProStrakan, Inc. FENTANYL CITRATE 100 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42747-222_d07bb89b-1d6e-43a0-839d-d85a8f0619c5 42747-222 HUMAN PRESCRIPTION DRUG Abstral fentanyl TABLET SUBLINGUAL 20110107 NDA NDA022510 ProStrakan, Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42747-223_d07bb89b-1d6e-43a0-839d-d85a8f0619c5 42747-223 HUMAN PRESCRIPTION DRUG Abstral fentanyl TABLET SUBLINGUAL 20110107 NDA NDA022510 ProStrakan, Inc. FENTANYL CITRATE 300 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42747-224_d07bb89b-1d6e-43a0-839d-d85a8f0619c5 42747-224 HUMAN PRESCRIPTION DRUG Abstral fentanyl TABLET SUBLINGUAL 20110107 NDA NDA022510 ProStrakan, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42747-226_d07bb89b-1d6e-43a0-839d-d85a8f0619c5 42747-226 HUMAN PRESCRIPTION DRUG Abstral fentanyl TABLET SUBLINGUAL 20110107 NDA NDA022510 ProStrakan, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42747-228_d07bb89b-1d6e-43a0-839d-d85a8f0619c5 42747-228 HUMAN PRESCRIPTION DRUG Abstral fentanyl TABLET SUBLINGUAL 20110107 NDA NDA022510 ProStrakan, Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42747-235_af05dde8-1c06-4cd5-bcd0-8e318874536a 42747-235 HUMAN PRESCRIPTION DRUG Rectiv nitroglycerin OINTMENT RECTAL 20110621 NDA NDA021359 ProStrakan, Inc. NITROGLYCERIN 4 mg/g Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 42747-327_2cab8dd1-3a10-48e6-86ce-0e5275ed49e5 42747-327 HUMAN PRESCRIPTION DRUG Fareston toremifene citrate TABLET ORAL 19970630 NDA NDA020497 ProStrakan, Inc. TOREMIFENE CITRATE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 42747-726_42ce031c-e30f-4f5d-8a99-0b32128aaf87 42747-726 HUMAN PRESCRIPTION DRUG Sancuso granisetron PATCH TRANSDERMAL 20080912 NDA NDA022198 ProStrakan, Inc. GRANISETRON 3.1 mg/24h Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 42751-1070_a07b5b9a-5739-442e-978f-e7f2c77b4946 42751-1070 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20080206 UNAPPROVED MEDICAL GAS Fullerton Welding Supply NITROUS OXIDE 99 L/100L 42751-1072_a1d5d7fe-384d-43dc-9494-38abd2e184a3 42751-1072 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20080206 UNAPPROVED MEDICAL GAS Fullerton Welding Supply OXYGEN 99 L/100L 42756-1030_cc1bbc86-cbb2-4eb4-86d2-9845e69ee3be 42756-1030 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine Bitartrate Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088390 IQ Dental EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 42756-1080_d9f72b19-eb5d-4fc1-880c-cd73d87c96f3 42756-1080 HUMAN PRESCRIPTION DRUG IQ Dental Mepivacaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20120815 ANDA ANDA088387 IQ Dental MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 42766-001_24dce16c-d9fd-4e97-b486-cb9a97e52f19 42766-001 HUMAN OTC DRUG SAC-VAL Premium Clear Antiseptic Hand Wash CHLOROXYLENOL SOAP TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E Sac Val Janitorial Sales & Service, Inc. CHLOROXYLENOL 4 mg/mL 42783-101_9910c570-35f6-4748-bce0-a4cfb99f7af3 42783-101 HUMAN PRESCRIPTION DRUG ZITHRANOL-RR anthralin CREAM TOPICAL 20090709 UNAPPROVED DRUG OTHER Elorac Inc. ANTHRALIN .012 g/g 42783-111_29705f8e-766e-4ef9-9ca7-3e9a9dee9daa 42783-111 HUMAN PRESCRIPTION DRUG Zithranol Anthralin SHAMPOO TOPICAL 20120305 UNAPPROVED DRUG OTHER Elorac Inc. ANTHRALIN 1 g/100g 42783-312_91b5ab12-97ca-4765-a8ed-b125ade861da 42783-312 HUMAN PRESCRIPTION DRUG Virasal salicylic acid SOLUTION TOPICAL 20110401 UNAPPROVED DRUG OTHER Elorac, Inc. SALICYLIC ACID 275 mg/mL 42783-323_16ec022e-c61b-4146-8128-fb3f588a0270 42783-323 HUMAN PRESCRIPTION DRUG Ultrasal-ER salicylic acid SOLUTION TOPICAL 20140130 UNAPPROVED DRUG OTHER Elorac, Inc. SALICYLIC ACID 285 mg/mL 42783-601_8ed3aa48-aa05-43dc-8514-ed25f8111167 42783-601 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20051208 ANDA ANDA065285 Elorac, Inc. DOXYCYCLINE 100 mg/1 42783-601_e86d4ffc-96de-4bbf-b575-aa3be9d06e01 42783-601 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20051208 ANDA ANDA065285 Elorac, Inc. DOXYCYCLINE 100 mg/1 42783-610_81038d88-2899-40dd-a574-1eb133b33388 42783-610 HUMAN PRESCRIPTION DRUG NicAzel Doxy Kit Doxycycline tablets and NicAzelFORTE tablets KIT 20140630 UNAPPROVED DRUG OTHER Elorac, Inc. 42783-610_df157072-f688-4b7a-94d4-1b367a29dcdf 42783-610 HUMAN PRESCRIPTION DRUG NicAzelDoxy Kit Doxycycline tablets and NicAzelFORTE tablets KIT 20140630 UNAPPROVED DRUG OTHER Elorac, Inc. 42783-612_a814bf20-3c1c-4e05-a27e-6f0a5db740ff 42783-612 HUMAN PRESCRIPTION DRUG BenoxylDoxy 30 Kit Doxycycline tablets and Benoxyl-CR Advanced Acne Wash KIT 20140701 UNAPPROVED DRUG OTHER Elorac, Inc. 42783-622_df9737d1-62e8-480b-8648-9380ea940261 42783-622 HUMAN PRESCRIPTION DRUG BenoxylDoxy 60 Kit Doxycycline tablets and Benoxyl-CR Advanced Acne Wash KIT 20140701 UNAPPROVED DRUG OTHER Elorac, Inc. 42783-630_7accdb6a-1795-4aa5-a067-36f6150b294a 42783-630 HUMAN OTC DRUG Benoxyl-CR Advanced Acne Wash Benzoyl Peroxide LIQUID, EXTENDED RELEASE TOPICAL 20140630 OTC MONOGRAPH FINAL part333D Elorac, Inc. BENZOYL PEROXIDE 44 mg/mL 42787-101_45375d2d-b519-4e3c-800e-b3eefa0e6857 42787-101 HUMAN OTC DRUG Value Pharma Aspirin Pain Reliever Aspirin TABLET ORAL 20121001 OTC MONOGRAPH FINAL part343 Ajes Pharmaceuticals,LLC ASPIRIN 81 mg/81mg 42787-101_83ab9ae9-51ce-4763-a39a-03585c908116 42787-101 HUMAN OTC DRUG Value Pharma Aspirin Pain Reliever Aspirin TABLET ORAL 20121001 OTC MONOGRAPH FINAL part343 Ajes Pharmaceuticals,LLC ASPIRIN 81 mg/81mg 42787-102_615db3ad-3529-4e96-962a-96324d2c5c97 42787-102 HUMAN OTC DRUG Value PharmaPain Reliever Extra Strength Aspirin TABLET ORAL 20121001 OTC MONOGRAPH FINAL part343 Ajes Pharmaceuticals,LLC ASPIRIN 325 mg/325mg 42787-102_893f4de2-d639-4e24-9c95-741b3f90a25e 42787-102 HUMAN OTC DRUG Value PharmaPain Reliever Extra Strength Aspirin TABLET ORAL 20121001 OTC MONOGRAPH FINAL part343 Ajes Pharmaceuticals,LLC ASPIRIN 325 mg/325mg 42787-104_33e8167f-3d6f-42eb-be0e-abe2dcb25f5d 42787-104 HUMAN OTC DRUG BENALDRYL DIPHENHYDRAMINE HCL TABLET ORAL 20120901 OTC MONOGRAPH NOT FINAL part348 AJES PHARMACEUTICALS,LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/250mg 42787-104_6854488c-af16-4d30-9a24-bcf3aafac41e 42787-104 HUMAN OTC DRUG BENALDRYL DIPHENHYDRAMINE HCL TABLET ORAL 20120901 OTC MONOGRAPH NOT FINAL part348 AJES PHARMACEUTICALS,LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/250mg 42787-105_6558ce50-cba7-464e-9cad-a0206629c2ef 42787-105 HUMAN OTC DRUG SENOKOT-S Docuset Sodium PILL ORAL 20120901 OTC MONOGRAPH NOT FINAL part334 Ajes Pharmaceuticals,LLC DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/340mg; mg/340mg 42792-101_ac957b3e-745f-417a-a238-2293951bba9d 42792-101 HUMAN PRESCRIPTION DRUG UREA UREA CREAM TOPICAL 20110309 UNAPPROVED DRUG OTHER AUSTIN PHARMACEUTICALS, LLC UREA 390 mg/g 42792-102_46f6ee0a-9a31-489a-b4a8-c2e952205a0a 42792-102 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE, SULFUR SODIUM SULFACETAMIDE, SULFUR LOTION TOPICAL 20110430 UNAPPROVED DRUG OTHER AUSTIN PHARMACEUTICALS, LLC SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42792-103_352be91e-3177-458e-9994-c02101583574 42792-103 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE, SULFUR SODIUM SULFACETAMIDE, SULFUR CREAM TOPICAL 20110430 UNAPPROVED DRUG OTHER AUSTIN PHARMACEUTICALS, LLC SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42792-104_6d49816e-7090-4cad-800a-552b1a0c9d80 42792-104 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE, SULFUR SODIUM SULFACETAMIDE, SULFUR SUSPENSION TOPICAL 20110604 UNAPPROVED DRUG OTHER AUSTIN PHARMACEUTICALS, LLC SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42792-106_9763fa5e-c309-4350-8039-09a99b72488d 42792-106 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE SULFACETAMIDE SODIUM LIQUID TOPICAL 20110915 UNAPPROVED DRUG OTHER Austin Pharmaceuticals, LLC SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42792-107_ef8d1a87-125b-4286-92e8-0b88269db73f 42792-107 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE, SULFUR SODIUM SULFACETAMIDE, SULFUR LOTION TOPICAL 20110604 UNAPPROVED DRUG OTHER AUSTIN PHARMACEUTICALS, LLC SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42792-108_25c14acb-cf86-4fe9-8209-b8f00950c923 42792-108 HUMAN PRESCRIPTION DRUG UREA UREA GEL TOPICAL 20101126 UNAPPROVED DRUG OTHER AUSTIN PHARMACEUTICALS, LLC UREA 400 mg/mL 42794-003_165f8b4d-7e7c-4a64-850e-50e325549151 42794-003 HUMAN PRESCRIPTION DRUG ADEFOVIR DIPIVOXIL ADEFOVIR DIPIVOXIL TABLET ORAL 20130903 ANDA ANDA202051 Sigmapharm Laboratories, LLC ADEFOVIR DIPIVOXIL 10 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 42794-006_82aa1a28-0cb4-479d-98a5-eadef2607f6a 42794-006 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20120128 ANDA ANDA091004 SigmaPharm Laboratories, LLC ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 42794-018_ad3036c4-14e7-469d-8bdd-da443caddb75 42794-018 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20121130 ANDA ANDA200295 SIGMAPHARM LABORATORIES, LLC LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 42794-019_ad3036c4-14e7-469d-8bdd-da443caddb75 42794-019 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20121130 ANDA ANDA200295 SIGMAPHARM LABORATORIES, LLC LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 42794-020_ad3036c4-14e7-469d-8bdd-da443caddb75 42794-020 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20121130 ANDA ANDA200295 SIGMAPHARM LABORATORIES, LLC LIOTHYRONINE SODIUM 50 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 42794-086_d71fe835-fb62-4e1b-bab1-fa40c9bb2f93 42794-086 HUMAN PRESCRIPTION DRUG Sodium Phenylbutyrate Sodium Phenylbutyrate POWDER ORAL 20130403 ANDA ANDA202819 Sigmapharm Laboratories, LLC SODIUM PHENYLBUTYRATE .94 g/g Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] 42799-105_520bf7d8-4b5c-407e-ae3d-aef07547e0e1 42799-105 HUMAN PRESCRIPTION DRUG Methenamine Mandelate Methenamine Mandelate TABLET ORAL 20091215 UNAPPROVED DRUG OTHER Edenbridge Pharmaceuticals, LLC METHENAMINE MANDELATE 500 mg/1 42799-106_520bf7d8-4b5c-407e-ae3d-aef07547e0e1 42799-106 HUMAN PRESCRIPTION DRUG Methenamine Mandelate Methenamine Mandelate TABLET ORAL 20091215 UNAPPROVED DRUG OTHER Edenbridge Pharmaceuticals, LLC METHENAMINE MANDELATE 1000 mg/1 42799-113_34fdc0aa-9062-44e2-ae10-b435f36ca767 42799-113 HUMAN PRESCRIPTION DRUG Stavudine Stavudine POWDER, FOR SOLUTION ORAL 20120401 ANDA ANDA078030 Edenbridge Pharmaceuticals, LLC STAVUDINE 1 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 42799-217_4454ef57-d5e1-42ca-82c4-0459c86d8974 42799-217 HUMAN PRESCRIPTION DRUG Opium Tincture Deodorized Morphine TINCTURE ORAL 20100715 UNAPPROVED DRUG OTHER Edenbridge Pharmaceuticals, LLC MORPHINE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42799-403_c2002324-a271-4402-8f39-8cdbcfd61080 42799-403 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine CAPSULE ORAL 20120401 ANDA ANDA078349 Edenbridge Pharmaceuticals, LLC ZIDOVUDINE 100 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 42799-404_d015cd89-af35-44c1-a714-27480d487676 42799-404 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine SYRUP ORAL 20120401 ANDA ANDA077981 Edenbridge Pharmaceuticals, LLC ZIDOVUDINE 50 mg/5mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 42799-806_247d3f17-49a9-4608-bd48-f2bb2228705c 42799-806 HUMAN PRESCRIPTION DRUG Ivermectin Ivermectin TABLET ORAL 20141115 ANDA ANDA204154 Edenbridge Pharmaceuticals, LLC IVERMECTIN 3 mg/1 Antiparasitic [EPC],Pediculicide [EPC] 42806-011_c5a6dab9-0f1f-41df-b8a3-c03cb0e9c6ce 42806-011 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20100125 ANDA ANDA072711 Epic Pharma, LLC SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42806-012_b3321c08-de30-402f-ac5e-da6f0fd051a3 42806-012 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120430 ANDA ANDA200294 Epic Pharma, LLC MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 42806-013_bbffaccc-54f0-4fe4-88b7-f2f3e78d73f8 42806-013 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate Sodium Polystyrene Sulfonate POWDER, FOR SUSPENSION ORAL 20140414 ANDA ANDA202333 Epic Pharma, LLC SODIUM POLYSTYRENE SULFONATE 4.1 meq/g 42806-014_b3321c08-de30-402f-ac5e-da6f0fd051a3 42806-014 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120430 ANDA ANDA200294 Epic Pharma, LLC MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 42806-018_c5a6dab9-0f1f-41df-b8a3-c03cb0e9c6ce 42806-018 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20100125 ANDA ANDA072711 Epic Pharma, LLC SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 42806-019_ad1f5e50-a9a2-4518-883e-7f61e26220f2 42806-019 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET, FILM COATED ORAL 20110520 ANDA ANDA077045 Epic Pharma, LLC CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42806-020_ad1f5e50-a9a2-4518-883e-7f61e26220f2 42806-020 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET, FILM COATED ORAL 20110520 ANDA ANDA077045 Epic Pharma, LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42806-021_ad1f5e50-a9a2-4518-883e-7f61e26220f2 42806-021 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET, FILM COATED ORAL 20110520 ANDA ANDA077045 Epic Pharma, LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 42806-038_597997e7-9086-4b1a-833c-b2ad3ea03fa7 42806-038 HUMAN PRESCRIPTION DRUG Betaxolol Betaxolol TABLET, FILM COATED ORAL 20100720 ANDA ANDA075541 Epic Pharma LLC BETAXOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 42806-039_597997e7-9086-4b1a-833c-b2ad3ea03fa7 42806-039 HUMAN PRESCRIPTION DRUG Betaxolol Betaxolol TABLET, FILM COATED ORAL 20100720 ANDA ANDA075541 Epic Pharma LLC BETAXOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 42806-048_fac4a4c2-f5f0-46ef-b76b-315abe9136fa 42806-048 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 20131202 ANDA ANDA074673 Epic Pharma, LLC GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 42806-049_fac4a4c2-f5f0-46ef-b76b-315abe9136fa 42806-049 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 20131202 ANDA ANDA074673 Epic Pharma, LLC GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 42806-050_141ac200-8234-4d4e-80ff-90cee779533a 42806-050 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 20110505 ANDA ANDA040331 Epic Pharma, LLC MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42806-051_141ac200-8234-4d4e-80ff-90cee779533a 42806-051 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 20110505 ANDA ANDA040331 Epic Pharma, LLC MEPERIDINE HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42806-055_b5c9eebe-f8a8-4f56-b2a9-b513e1b16023 42806-055 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110425 ANDA ANDA078552 Epic Pharma, LLC AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 42806-056_b5c9eebe-f8a8-4f56-b2a9-b513e1b16023 42806-056 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110425 ANDA ANDA078552 Epic Pharma, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 42806-057_b5c9eebe-f8a8-4f56-b2a9-b513e1b16023 42806-057 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110425 ANDA ANDA078552 Epic Pharma, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 42806-058_4b1c4ffb-d3b3-4674-ac1c-626cf8d36d73 42806-058 HUMAN PRESCRIPTION DRUG Flavoxate Hydrochloride Flavoxate Hydrochloride TABLET ORAL 20110221 ANDA ANDA076835 Epic Pharma, LLC FLAVOXATE HYDROCHLORIDE 100 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 42806-096_fa10b911-5e96-40d7-b473-03b581531fab 42806-096 HUMAN PRESCRIPTION DRUG Protriptyline Hydrochloride Protriptyline Hydrochloride TABLET, FILM COATED ORAL 20130109 ANDA ANDA202220 Epic Pharma, LLC PROTRIPTYLINE HYDROCHLORIDE 5 mg/1 Tricyclic Antidepressant [EPC] 42806-097_fa10b911-5e96-40d7-b473-03b581531fab 42806-097 HUMAN PRESCRIPTION DRUG Protriptyline Hydrochloride Protriptyline Hydrochloride TABLET, FILM COATED ORAL 20130109 ANDA ANDA202220 Epic Pharma, LLC PROTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 42806-263_cd688799-036a-4429-88d7-da84d9762d4d 42806-263 HUMAN PRESCRIPTION DRUG Isradipine Isradipine CAPSULE ORAL 20140515 ANDA ANDA077169 Epic Pharma, LLC ISRADIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 42806-264_cd688799-036a-4429-88d7-da84d9762d4d 42806-264 HUMAN PRESCRIPTION DRUG Isradipine Isradipine CAPSULE ORAL 20140515 ANDA ANDA077169 Epic Pharma, LLC ISRADIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 42806-501_6b6d4409-62d3-4c7f-bf50-cfc10c643b86 42806-501 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride CAPSULE ORAL 20100505 ANDA ANDA074928 Epic Pharma, LLC NICARDIPINE HYDROCHLORIDE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 42806-502_6b6d4409-62d3-4c7f-bf50-cfc10c643b86 42806-502 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride CAPSULE ORAL 20100505 ANDA ANDA074928 Epic Pharma, LLC NICARDIPINE HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 42806-503_39f3d532-06ad-4e91-86aa-a87567205e3c 42806-503 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20100716 ANDA ANDA075517 Epic Pharma, LLC URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 42808-100_0d92c55b-5b54-4f5d-8921-24e4e877ae50 42808-100 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE SODIUM SULFACETAMIDE LIQUID TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42808-101_b340e364-311c-4587-a8e7-aefdf489345e 42808-101 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide SODIUM SULFACETAMIDE SWAB TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42808-110_c9566966-0df9-4c60-a42e-522b429ca4b5 42808-110 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE, SULFUR SODIUM SULFACETAMIDE, SULFUR SOLUTION TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42808-111_ba8d1721-c654-4a0d-b9d3-acfb9d282eda 42808-111 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide, Sulfur Sodium Sulfacetamide, Sulfur GEL TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 42808-200_8d08d29e-c07d-4833-b6c6-748c146a3886 42808-200 HUMAN PRESCRIPTION DRUG Urea Urea CREAM TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. UREA 500 mg/g 42808-201_50677dcb-d3f3-4f2b-a433-a193c05d861f 42808-201 HUMAN PRESCRIPTION DRUG Urea Urea SUSPENSION TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. UREA 500 mg/g 42808-202_e4516083-fb4d-4550-a6d7-31fb5bb93a24 42808-202 HUMAN PRESCRIPTION DRUG UREA UREA CREAM TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. UREA 450 mg/g 42808-204_b58e175d-60e8-4206-ac7a-c67b68ac80f0 42808-204 HUMAN PRESCRIPTION DRUG Urea Urea GEL TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. UREA 450 mg/mL 42808-205_df94c282-b701-461b-b3ae-64dfc846cd31 42808-205 HUMAN PRESCRIPTION DRUG Urea Urea EMULSION TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. UREA 500 mg/mL 42808-206_2108d9a8-7f48-432d-8694-05681f502435 42808-206 HUMAN PRESCRIPTION DRUG UREA UREA EMULSION TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. UREA 500 mg/g 42808-300_8a4f81b5-6b95-47be-ac6a-3336dc6bb046 42808-300 HUMAN PRESCRIPTION DRUG Salicylic Acid SALICYLIC ACID GEL TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. SALICYLIC ACID 60 mg/g 42808-301_5152d83a-bf92-4539-9d95-4fe3e1be0181 42808-301 HUMAN PRESCRIPTION DRUG SALICYLIC ACID SALICYLIC ACID LOTION TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. SALICYLIC ACID 60 mg/g 42808-302_84bf2a98-1c69-4e09-b113-b114c9f30d52 42808-302 HUMAN PRESCRIPTION DRUG SALICYLIC ACID SALICYLIC ACID CREAM TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. SALICYLIC ACID 60 mg/g 42808-399_129ccc6e-4eb2-495d-8583-427cb223b783 42808-399 HUMAN PRESCRIPTION DRUG Salicylic Acid SALICYLIC ACID KIT 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. 42808-405_9260133a-3aa3-4b91-9929-20e7369c0867 42808-405 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20120112 ANDA ANDA040547 Exact-Rx, Inc. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 42808-410_9260133a-3aa3-4b91-9929-20e7369c0867 42808-410 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20120112 ANDA ANDA040547 Exact-Rx, Inc. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 42808-500_1c455f7b-683e-4327-94fc-6ce935efb32a 42808-500 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate Sodium Polystyrene Sulfonate POWDER, FOR SUSPENSION ORAL; RECTAL 20120401 ANDA ANDA090313 Exact-Rx, Inc. SODIUM POLYSTYRENE SULFONATE 4.1 meq/g 42809-0002_71f45642-dc4b-48cd-bdb4-162cfa4918d4 42809-0002 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Express Medical Inc OXYGEN 99 L/100L 42821-001_9e9c480a-3f82-4576-8079-38c7213af982 42821-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19000101 UNAPPROVED MEDICAL GAS T & C Flynn's Pharmacy Inc OXYGEN 990 mL/L 42825-100_e6f3adb8-c116-4124-acdd-3f2283edc79d 42825-100 HUMAN OTC DRUG Aloe Scent A B Hand Sanitizing ALCOHOL SPRAY TOPICAL 20100625 OTC MONOGRAPH FINAL part333 Custom HBC Corporation ALCOHOL 62 mL/100mL 42847-103_83365e51-677a-4496-9e9b-bfc1e81a71ce 42847-103 HUMAN PRESCRIPTION DRUG Silenor doxepin hydrochloride TABLET ORAL 20100801 NDA NDA022036 Pernix Therapeutics, LLC DOXEPIN HYDROCHLORIDE 3 mg/1 Tricyclic Antidepressant [EPC] 42847-106_83365e51-677a-4496-9e9b-bfc1e81a71ce 42847-106 HUMAN PRESCRIPTION DRUG Silenor doxepin hydrochloride TABLET ORAL 20100801 NDA NDA022036 Pernix Therapeutics, LLC DOXEPIN HYDROCHLORIDE 6 mg/1 Tricyclic Antidepressant [EPC] 42851-030_d0f0ed2a-0557-4dff-ad6d-4ace56805e2a 42851-030 HUMAN PRESCRIPTION DRUG MELAMIN Skin Bleaching and Correcting Hydroquinone CREAM TOPICAL 20120101 UNAPPROVED DRUG OTHER ZO Skin Health, Inc. HYDROQUINONE .04 g/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 42851-031_cd0910a6-6a79-437e-bc91-00e7f13cc61a 42851-031 HUMAN PRESCRIPTION DRUG MELAMIX Skin Lightener and Blending Hydroquinone CREAM TOPICAL 20120101 UNAPPROVED DRUG OTHER ZO Skin Health, Inc. HYDROQUINONE .04 g/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 42851-032_d2083da3-67bd-4f36-a105-a088a50dd5e0 42851-032 HUMAN PRESCRIPTION DRUG MELAMIN Skin Bleaching and Correcting Hydroquinone HYDROQUINONE CREAM TOPICAL 20140701 UNAPPROVED DRUG OTHER ZO Skin Health, Inc. HYDROQUINONE .04 g/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 42851-033_bd7c76fb-1809-4600-8cac-d2a104880fe9 42851-033 HUMAN PRESCRIPTION DRUG MELAMIX Skin Lightener and Blending HYDROQUINONE CREAM TOPICAL 20140701 UNAPPROVED DRUG OTHER ZO Skin Health, Inc. HYDROQUINONE .04 g/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 42851-050_ca1cf074-eae6-4a2d-8beb-a88dcbaa9ba5 42851-050 HUMAN OTC DRUG ORASER DAILY HAND REPAIR Broad-Spectrum SPF 20 Sunscreen Avobenzone, Octinoxate, and Oxybenzone LOTION TOPICAL 20120101 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE 30; 75; 20 mg/mL; mg/mL; mg/mL 42851-051_0a6a88c6-e444-4bd6-beb1-0fe7a05ed841 42851-051 HUMAN OTC DRUG OCLIPSE Sunscreen plus Primer Broad-Spectrum SPF 30 UVA/UVB Protection Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20120101 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. TITANIUM DIOXIDE; ZINC OXIDE 102; 37 mg/mL; mg/mL 42851-052_b6d7357e-fb39-49c7-a081-23793e7298ce 42851-052 HUMAN OTC DRUG ZO MEDICAL OCLIPSE-C Broad-Spectrum Sunscreen SPF 50 Titanium Dioxide LOTION TOPICAL 20120101 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. TITANIUM DIOXIDE .08 g/g 42851-070_51370c3b-1d6c-439c-979b-2835fb57413a 42851-070 HUMAN OTC DRUG AKNETROL Acne Treatment Benzoyl Peroxide LOTION TOPICAL 20120101 OTC MONOGRAPH FINAL part333D ZO Skin Health, Inc. BENZOYL PEROXIDE 100 mg/mL 42851-071_efc8ea10-0517-499c-bfaa-ab6e6f39b0ff 42851-071 HUMAN OTC DRUG CEBATROL Oil Control Pads Salicylic Acid SOLUTION TOPICAL 20120101 OTC MONOGRAPH FINAL part333D ZO Skin Health, Inc. SALICYLIC ACID 20 mg/mL 42851-077_cd493e62-b4fe-4812-93f8-51a848f16468 42851-077 HUMAN OTC DRUG VITASCRUB Invigorating Foaming Scrub SALICYLIC ACID LOTION TOPICAL 20130517 OTC MONOGRAPH FINAL part333D ZO Skin Health, Inc. SALICYLIC ACID 20 mg/g 42851-078_f3a3f26a-615e-4455-9b2a-775baa3d528a 42851-078 HUMAN OTC DRUG OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM SALICYLIC ACID SOLUTION TOPICAL 20110101 OTC MONOGRAPH FINAL part333D ZO Skin Health, Inc. SALICYLIC ACID 20 mg/mL 42851-152_c7e76e3e-a107-49f5-b32e-de5d9682cc6e 42851-152 HUMAN OTC DRUG ZO SKIN HEALTH LEVEL I DAILY SKINCARE PROGRAM Essentials for Healthy Skin TITANIUM DIOXIDE AND ZINC OXIDE KIT 20120101 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. 42851-153_4c425570-8195-4691-a8ec-6f121328d64e 42851-153 HUMAN OTC DRUG ZO SKIN HEALTH LEVEL II ANTI-AGING PROGRAM with Growth Factor Serum Plus Titanium Dioxide and Zinc Oxide KIT 20120111 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. 42851-154_ce971d5b-db59-4534-9594-9c64c541bc50 42851-154 HUMAN OTC DRUG ZO SKIN HEALTH LEVEL III AGGRESSIVE ANTI-AGING PROGRAM with Advanced Radical Night Repair Titanium Dioxide and Zinc Oxide KIT 20120111 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. 42851-155_f74e99ed-574f-46d5-bda5-c5cf16c674b5 42851-155 HUMAN OTC DRUG ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA and OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION TITANIUM DIOXIDE and ZINC OXIDE KIT 20120101 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. 42851-157_087bd906-1a09-47ef-86b0-6201dbf75b64 42851-157 HUMAN OTC DRUG ZO SKIN HEALTH SunSmart Triple Protection Program Natural Melanin and Antioxidant Defenders with Sunscreen plus Primer SPF 30 TITANIUM DIOXIDE and ZINC OXIDE KIT 20140501 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. 42852-001_e846c0f9-f552-4f43-92f4-8541668912af 42852-001 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET ORAL 20110701 ANDA ANDA075593 Apothecary Shop Wholesale Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 42852-002_0cf70670-7217-46be-9a64-27beb7b9d02b 42852-002 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20110701 ANDA ANDA065095 Apothecary Shop Wholesale Inc. DOXYCYCLINE HYCLATE 100 mg/1 42852-003_c78e92fe-c381-4afa-b221-c03cc5e391d7 42852-003 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20110701 ANDA ANDA076077 Apothecary Shop Wholesale Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 42853-102_2c3257ea-c42e-43ec-b1ec-755e9dd7b6f3 42853-102 HUMAN OTC DRUG ALL-IN-ONE BENZOYL PEROXIDE CREAM TOPICAL 20120225 OTC MONOGRAPH FINAL part333D AUGUSTUS BIOMED LLC BENZOYL PEROXIDE 5.5 g/100mL 42856-001_a70f020f-24f1-4db8-b6f2-9fa27fd71594 42856-001 HUMAN OTC DRUG Antibacterial Wet Wipes Triclosan SWAB TOPICAL 20120312 OTC MONOGRAPH NOT FINAL part333A MAKESELLER GROUP INC. TRICLOSAN .2 g/100g 42858-001_62348b93-9ffd-4706-80b3-d66b5ae073d3 42858-001 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20140908 ANDA ANDA091490 Rhodes Pharmaceuticals L.P. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42858-002_62348b93-9ffd-4706-80b3-d66b5ae073d3 42858-002 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20140908 ANDA ANDA091490 Rhodes Pharmaceuticals L.P. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42858-003_62348b93-9ffd-4706-80b3-d66b5ae073d3 42858-003 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20140908 ANDA ANDA091490 Rhodes Pharmaceuticals L.P. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42858-004_62348b93-9ffd-4706-80b3-d66b5ae073d3 42858-004 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20140908 ANDA ANDA091490 Rhodes Pharmaceuticals L.P. OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42858-005_62348b93-9ffd-4706-80b3-d66b5ae073d3 42858-005 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20140908 ANDA ANDA091490 Rhodes Pharmaceuticals L.P. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42858-102_bdc11908-10a1-4eaf-9924-e71e5d0bf4c6 42858-102 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20140828 ANDA ANDA201278 Rhodes Pharmaceuticals L.P. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42858-103_bdc11908-10a1-4eaf-9924-e71e5d0bf4c6 42858-103 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20140828 ANDA ANDA201278 Rhodes Pharmaceuticals L.P. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42858-104_bdc11908-10a1-4eaf-9924-e71e5d0bf4c6 42858-104 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20140828 ANDA ANDA201278 Rhodes Pharmaceuticals L.P. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42858-301_4de0d911-285b-4d8d-bdd5-347635d02d2c 42858-301 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091123 NDA AUTHORIZED GENERIC NDA019892 Rhodes Pharmaceuticals L.P. HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42858-302_4de0d911-285b-4d8d-bdd5-347635d02d2c 42858-302 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091123 NDA AUTHORIZED GENERIC NDA019892 Rhodes Pharmaceuticals L.P. HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42858-303_4de0d911-285b-4d8d-bdd5-347635d02d2c 42858-303 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091123 NDA AUTHORIZED GENERIC NDA019892 Rhodes Pharmaceuticals L.P. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42858-304_4de0d911-285b-4d8d-bdd5-347635d02d2c 42858-304 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride SOLUTION ORAL 20120720 NDA AUTHORIZED GENERIC NDA019891 Rhodes Pharmaceuticals L.P. HYDROMORPHONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42858-701_959a4853-63f0-4f54-a310-6080a732dc4a 42858-701 HUMAN PRESCRIPTION DRUG Theophylline Anhydrous Theophylline TABLET, EXTENDED RELEASE ORAL 20120202 ANDA ANDA087571 Rhodes Pharmaceuticals L.P. THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 42858-702_959a4853-63f0-4f54-a310-6080a732dc4a 42858-702 HUMAN PRESCRIPTION DRUG Theophylline Anhydrous Theophylline TABLET, EXTENDED RELEASE ORAL 20120202 ANDA ANDA040086 Rhodes Pharmaceuticals L.P. THEOPHYLLINE ANHYDROUS 600 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 42858-801_7019424e-8276-4d77-9914-75f364598931 42858-801 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Rhodes Pharmaceuticals L. P. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42858-802_7019424e-8276-4d77-9914-75f364598931 42858-802 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Rhodes Pharmaceuticals L. P. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42858-803_7019424e-8276-4d77-9914-75f364598931 42858-803 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Rhodes Pharmaceuticals L. P. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42858-804_7019424e-8276-4d77-9914-75f364598931 42858-804 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074769 Rhodes Pharmaceuticals L. P. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42858-805_7019424e-8276-4d77-9914-75f364598931 42858-805 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074769 Rhodes Pharmaceuticals L. P. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42865-100_956723f6-10c9-4b14-bce2-f40b23d22b0c 42865-100 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20090922 20170101 NDA NDA022210 Aptalis Pharma US, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 27000; 5000; 17000 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 42865-101_956723f6-10c9-4b14-bce2-f40b23d22b0c 42865-101 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20090922 20170101 NDA NDA022210 Aptalis Pharma US, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 55000; 10000; 34000 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 42865-102_956723f6-10c9-4b14-bce2-f40b23d22b0c 42865-102 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20090922 20170101 NDA NDA022210 Aptalis Pharma US, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 82000; 15000; 51000 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 42865-103_956723f6-10c9-4b14-bce2-f40b23d22b0c 42865-103 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20090922 20170101 NDA NDA022210 Aptalis Pharma US, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 109000; 20000; 68000 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 42865-104_956723f6-10c9-4b14-bce2-f40b23d22b0c 42865-104 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20090922 20170101 NDA NDA022210 Aptalis Pharma US, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 16000; 3000; 10000 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 42865-105_956723f6-10c9-4b14-bce2-f40b23d22b0c 42865-105 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20110719 20170101 NDA NDA022210 Aptalis Pharma US, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 136000; 25000; 85000 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 42865-300_956723f6-10c9-4b14-bce2-f40b23d22b0c 42865-300 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20090922 NDA NDA022210 Aptalis Pharma US, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 27000; 5000; 17000 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 42865-302_956723f6-10c9-4b14-bce2-f40b23d22b0c 42865-302 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20090922 NDA NDA022210 Aptalis Pharma US, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 82000; 15000; 51000 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 42865-303_956723f6-10c9-4b14-bce2-f40b23d22b0c 42865-303 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20090922 NDA NDA022210 Aptalis Pharma US, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 109000; 20000; 68000 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 42865-304_956723f6-10c9-4b14-bce2-f40b23d22b0c 42865-304 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20090922 NDA NDA022210 Aptalis Pharma US, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 16000; 3000; 10000 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 42865-305_956723f6-10c9-4b14-bce2-f40b23d22b0c 42865-305 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20110719 NDA NDA022210 Aptalis Pharma US, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 136000; 25000; 85000 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 42865-306_956723f6-10c9-4b14-bce2-f40b23d22b0c 42865-306 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20090922 NDA NDA022210 Aptalis Pharma US, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 55000; 10000; 34000 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 42865-307_956723f6-10c9-4b14-bce2-f40b23d22b0c 42865-307 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20110719 NDA NDA022210 Aptalis Pharma US, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 218000; 40000; 136000 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 42874-012_e8aa934c-d74e-4c7c-b2fc-d3b8b46f4529 42874-012 VACCINE Flublok Influenza Vaccine INJECTION, SOLUTION INTRAMUSCULAR 20130201 BLA BLA125285 Protein Sciences Corporation INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/VICTORIA/361/2011 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/WISCONSIN/1/2010 RECOMBINANT HEMAGGLUTININ ANTIGEN 45; 45; 45 ug/.5mL; ug/.5mL; ug/.5mL 42874-013_fb2aad7e-82d2-47c0-9eb3-08ac62641a47 42874-013 VACCINE Flublok Influenza Vaccine INJECTION, SOLUTION INTRAMUSCULAR 20131101 BLA BLA125285 Protein Sciences Corporation INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/TEXAS/50/2012 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 RECOMBINANT HEMAGGLUTININ ANTIGEN 45; 45; 45 ug/.5mL; ug/.5mL; ug/.5mL 42874-014_831d38cc-1793-4de9-8176-46e7a9f60756 42874-014 VACCINE Flublok Influenza Vaccine INJECTION, SOLUTION INTRAMUSCULAR 20140915 BLA BLA125285 Protein Sciences Corporation INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/TEXAS/50/2012 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 RECOMBINANT HEMAGGLUTININ ANTIGEN 45; 45; 45 ug/.5mL; ug/.5mL; ug/.5mL 42876-001_5bcb429b-3625-439a-bc62-36c027f98e0c 42876-001 HUMAN OTC DRUG COMPLEXION CLEAR ACNE TREATMENT SALICYLIC ACID LIQUID TOPICAL 20120229 OTC MONOGRAPH FINAL part333D Results RNA, LLC SALICYLIC ACID 2 mL/100mL 42876-002_347db891-4f8b-43d2-bb93-48325641bd85 42876-002 HUMAN OTC DRUG NEXICLEAR ACNE TREATMENT SALICYLIC ACID LIQUID TOPICAL 20120229 OTC MONOGRAPH FINAL part333D Results RNA, LLC SALICYLIC ACID 2 mL/100mL 42876-003_346d76a9-106a-43cd-a24d-ccfe69fff8de 42876-003 HUMAN OTC DRUG Complexion Clear Acne Treatment Rejuvenating BENZOYL PEROXIDE CREAM TOPICAL 20121107 OTC MONOGRAPH FINAL part333D Results RNA, LLC BENZOYL PEROXIDE 25 mg/mL 42877-001_968feffc-85c5-457e-a110-27001c8be572 42877-001 HUMAN OTC DRUG skin effects Firming Facial with Retinol Complex SPF 30 AVOBENZONE, OCTINOXATE,OCTISALATE CREAM TOPICAL 20110928 OTC MONOGRAPH NOT FINAL part352 Diversified Global Technologies DBA Diversified Distribution AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100g; g/100g; g/100g 42877-002_280eb7c5-9b5f-4ff7-9b4a-81f9e177874f 42877-002 HUMAN OTC DRUG skin effects Brightening Day SPF 50 AVOBENZONE, HOMOSALATE, OCTINOXATE,OCTISALATE CREAM TOPICAL 20110928 OTC MONOGRAPH NOT FINAL part352 Diversified Global Technologies DBA Diversified Distribution AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 3; 15; 7.5; 5 g/100g; g/100g; g/100g; g/100g 42877-092_d1cc3eda-aefb-406a-8780-c3a864934e1e 42877-092 HUMAN OTC DRUG Skin Effects by Dr. Jeffrey Dover Glycolic Day HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20100629 OTC MONOGRAPH FINAL part352 Diversified Global Technologies DBA Diversified Distribution AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 42884-352_40782ef6-3341-4c7f-9bd7-19e13d377612 42884-352 HUMAN OTC DRUG Zonnic Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20130503 ANDA ANDA078547 Niconovum USA Inc. NICOTINE 2 mg/1 42884-365_63fa7144-e192-497b-8f9c-23cbc487280b 42884-365 HUMAN OTC DRUG Zonnic Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20130503 ANDA ANDA091349 Niconovum USA Inc. NICOTINE 2 mg/1 42884-442_2bbed4d7-b00c-4762-8c64-72b80c88cfa9 42884-442 HUMAN OTC DRUG Zonnic Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20130503 ANDA ANDA091354 Niconovum USA Inc. NICOTINE 4 mg/1 42884-456_42a8fa49-b047-444b-a30e-d0696a16a129 42884-456 HUMAN OTC DRUG zonnic nicotine polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20120625 ANDA ANDA076777 Niconovum USA Inc. NICOTINE 2 mg/1 42884-532_a414639c-49f7-4893-9229-29eecbac3925 42884-532 HUMAN OTC DRUG zonnic nicotine polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20120627 ANDA ANDA076779 Niconovum USA Inc. NICOTINE 4 mg/1 42884-854_5bea2a18-94eb-41e7-8987-505586ce5275 42884-854 HUMAN OTC DRUG Zonnic Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20130503 ANDA ANDA078546 Niconovum USA Inc. NICOTINE 4 mg/1 42887-001_b8c9cce9-eabd-43ef-b151-21b95a7e2734 42887-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20010101 UNAPPROVED MEDICAL GAS North Central Respiratory, Inc OXYGEN 99 L/100L 42891-4148_7ae69b69-b35d-4ddc-b416-ead4afea86ce 42891-4148 HUMAN OTC DRUG AVVA Benzalkonium chloride GEL VAGINAL 20120328 OTC MONOGRAPH NOT FINAL part333A AVVA International LLC BENZALKONIUM CHLORIDE 100 mg/100mL 42893-011_530d6839-a303-4c5d-b123-d59514b7f894 42893-011 HUMAN OTC DRUG CHANTECAILLE Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 TITANIUM DIOXIDE LOTION TOPICAL 20140717 OTC MONOGRAPH NOT FINAL part352 Chantecaille Beaute Inc TITANIUM DIOXIDE 10.157 g/100g 42893-012_8db92986-6f10-4d1d-ba7a-aa2f79d4772a 42893-012 HUMAN OTC DRUG CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part352 Chantecaille Beaute Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 75; 50; 27.5 mg/mL; mg/mL; mg/mL; mg/mL 42893-020_9748d322-5be5-4871-ab43-a37d59650746 42893-020 HUMAN OTC DRUG CHANTECAILLE PROTECTION NATURELLE LIGHT SPF 46 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120306 OTC MONOGRAPH FINAL part352 Chantecaille Beaute Inc OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 2; 24.5 g/100g; g/100g; g/100g 42893-021_679a028a-3e6b-4254-b6eb-c108ef56fee6 42893-021 HUMAN OTC DRUG CHANTECAILLE PROTECTION NATURELLE LIGHT Refill SPF 46 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120306 OTC MONOGRAPH FINAL part352 Chantecaille Beaute Inc OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 2; 24.5 g/100g; g/100g; g/100g 42893-030_50de8449-69cf-4593-bdac-4aae7e7b4b7b 42893-030 HUMAN OTC DRUG CHANTECAILLE PROTECTION NATURELLE BRONZE SPF 46 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120306 OTC MONOGRAPH FINAL part352 Chantecaille Beaute Inc OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 2; 24.5 g/100g; g/100g; g/100g 42893-031_ce24783c-9a86-42c1-ae2b-f4de3dd6b6b1 42893-031 HUMAN OTC DRUG CHANTECAILLE PROTECTION NATURELLE BRONZE Refill SPF 46 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120306 OTC MONOGRAPH FINAL part352 Chantecaille Beaute Inc OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 2; 24.5 g/100g; g/100g; g/100g 42893-050_d8e76d5c-b53d-48c3-a63d-786e40116103 42893-050 HUMAN OTC DRUG CHANTECAILLE LIP SCREEN SPF 15 OCTINOXATE, OCTISALATE STICK TOPICAL 20120305 OTC MONOGRAPH FINAL part352 Chantecaille Beaute Inc OCTINOXATE; OCTISALATE 5.9; .49 g/100g; g/100g 42903-001_78fdf18e-e7e0-45ba-b679-4cc9afbe084a 42903-001 HUMAN OTC DRUG LivRelief Nerve Pain Relief Capsicum CREAM TOPICAL 20120501 UNAPPROVED HOMEOPATHIC LivCorp Inc. CAPSICUM 2 [hp_C]/50g 42903-002_46654b2d-9dbf-4e67-9fcb-e87d75a41837 42903-002 HUMAN OTC DRUG LivRelief Pain Relief Ruta graveolens CREAM TOPICAL 20120501 UNAPPROVED HOMEOPATHIC LivCorp Inc. RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]/50g 42903-003_efa4b105-41b9-416e-90a9-ecd2879a9afb 42903-003 HUMAN OTC DRUG LivSport Post-Workout Ruta CREAM TOPICAL 20120501 UNAPPROVED HOMEOPATHIC LivCorp Inc. RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]/100g 42903-004_07072561-cca3-45f4-a239-1b1bacf63bea 42903-004 HUMAN OTC DRUG LivSport PreWorkout with Heat Ruta, Rhus Tox, Arnica CREAM TOPICAL 20120501 UNAPPROVED HOMEOPATHIC LivCorp Inc. ARNICA MONTANA; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 8; 4; 8 [hp_X]/100g; [hp_X]/100g; [hp_X]/100g 42906-001_318ffcab-7025-4fac-827b-cf6269facc12 42906-001 HUMAN OTC DRUG Liquid Nature Antibacterial Hand Soap Liquid Nature Antibacterial Hand Soap SOLUTION TOPICAL 20090301 OTC MONOGRAPH NOT FINAL part333 VM Global Manufacturers Group Inc. TRICLOSAN .575 mL/500mL 42908-071_9521c4be-4c25-4822-b87c-af2b87766be8 42908-071 HUMAN OTC DRUG PAUL AND JOE SILKY SMOOTH FOUNDATION UV 100 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Albion Co., Ltd OCTINOXATE; TITANIUM DIOXIDE 50; 115.1 mg/mL; mg/mL 42908-072_e79f2e71-4eb6-453c-b7e6-fcdfe6030e98 42908-072 HUMAN OTC DRUG PAUL and JOE SILKY SMOOTH FOUNDATION UV 101 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Albion Co., Ltd OCTINOXATE; TITANIUM DIOXIDE 50; 115.1 mg/mL; mg/mL 42908-073_637f2bab-da97-4acc-bf23-1d85e46fd343 42908-073 HUMAN OTC DRUG PAUL AND JOE SILKY SMOOTH FOUNDATION UV 102 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Albion Co., Ltd OCTINOXATE; TITANIUM DIOXIDE 50; 115.1 mg/mL; mg/mL 42908-074_39fff27c-0a54-4449-9635-7851fa0363b2 42908-074 HUMAN OTC DRUG PAUL AND JOE SILKY SMOOTH FOUNDATION UV 103 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Albion Co., Ltd OCTINOXATE; TITANIUM DIOXIDE 50; 115.1 mg/mL; mg/mL 42908-075_37482967-13b4-40dc-9f72-5941bcf87fa4 42908-075 HUMAN OTC DRUG PAUL AND JOE SILKY SMOOTH FOUNDATION UV 201 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Albion Co., Ltd OCTINOXATE; TITANIUM DIOXIDE 50; 115.1 mg/mL; mg/mL 42908-076_fe31b09c-c3b5-4111-b947-25cc823d237f 42908-076 HUMAN OTC DRUG PAUL AND JOE SILKY SMOOTH FOUNDATION UV 301 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Albion Co., Ltd OCTINOXATE; TITANIUM DIOXIDE 50; 115.1 mg/mL; mg/mL 42908-077_ed283f0f-4872-451f-b068-b9c94b74ed97 42908-077 HUMAN OTC DRUG PAUL AND JOE SILKY SMOOTH FOUNDATION UV 302 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Albion Co., Ltd OCTINOXATE; TITANIUM DIOXIDE 50; 115.1 mg/mL; mg/mL 42908-201_f7b90afe-b683-4f1e-a908-9b0abac4a8ae 42908-201 HUMAN OTC DRUG PAUL AND JOE PROTECTIVE FOUNDATION PRIMER UV OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 Albion Co., Ltd OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 50; 59; 81 mg/mL; mg/mL; mg/mL 42912-0152_896e0b77-09de-4832-9c3d-d273005e5b43 42912-0152 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20100715 OTC MONOGRAPH NOT FINAL part343 TDS Pharm Co., Ltd ACETAMINOPHEN 500 mg/1 42912-0153_896e0b77-09de-4832-9c3d-d273005e5b43 42912-0153 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20100801 OTC MONOGRAPH NOT FINAL part343 TDS Pharm Co., Ltd ACETAMINOPHEN 500 mg/1 42912-0154_e47b7279-fe42-4741-86f2-62a998e8765d 42912-0154 HUMAN OTC DRUG Acetaminophen PM Acetaminophen, diphenhydramine HCl TABLET ORAL 20110128 OTC MONOGRAPH NOT FINAL part343 TDS Pharm Co., Ltd. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 42913-001_72aa0b56-fc63-48ba-8cbf-f346050f5ecc 42913-001 HUMAN OTC DRUG Power Stick XJ Coolblast Xtreme ALUMINUM SESQUICHLOROHYDRATE STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM SESQUICHLOROHYDRATE 200 mg/g 42913-002_9d57ca13-efa4-4796-a219-c281984f0833 42913-002 HUMAN OTC DRUG Soft Whisper Nectarine White Ginger ALUMINUM SESQUICHLOROHYDRATE STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM SESQUICHLOROHYDRATE 200 mg/g 42913-003_65173194-6ec3-48db-9704-3d8c0bca9c6a 42913-003 HUMAN OTC DRUG Power Stick XJ Eclipse ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.5 g/100g 42913-004_a17b0f26-216e-464e-a826-c5a1361f8b8a 42913-004 HUMAN OTC DRUG Power Stick XJ Indulgence ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.5 g/100g 42913-005_00e0d9da-8224-4e9b-82e4-70817551e083 42913-005 HUMAN OTC DRUG Power Stick XJ Chaos ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.5 g/100g 42913-006_1ea56037-42b6-4578-9cf9-835155d44649 42913-006 HUMAN OTC DRUG Power Stick XJ Intensity ALUMINUM SESQUICHLOROHYDRATE STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM SESQUICHLOROHYDRATE 200 mg/g 42913-007_f39d7d80-9cfa-44d6-9d9a-bf6d8b3b6380 42913-007 HUMAN OTC DRUG XTREME Power Stick Ignition ALUMINUM SESQUICHLOROHYDRATE STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM SESQUICHLOROHYDRATE 200 mg/g 42913-008_72ac7fca-d3b7-4f75-a717-c445196eaa8b 42913-008 HUMAN OTC DRUG Power Stick Powder Fresh ALUMINUM SESQUICHLOROHYDRATE STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM SESQUICHLOROHYDRATE 200 mg/g 42913-009_e49e3077-1262-474d-bb70-bf77e2f96507 42913-009 HUMAN OTC DRUG Power Stick Shower Fresh ALUMINUM SESQUICHLOROHYDRATE STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM SESQUICHLOROHYDRATE 200 mg/g 42913-010_a666614b-4e27-4dce-9f65-e7e3425bec7b 42913-010 HUMAN OTC DRUG Soft Whisper Cucumber Green Tea ALUMINUM SESQUICHLOROHYDRATE STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM SESQUICHLOROHYDRATE 200 mg/g 42913-011_9e190171-b48c-4da9-929b-e5b4943c568e 42913-011 HUMAN OTC DRUG Soft Whisper Pomegrante Lemon Verbena ALUMINUM SESQUICHLOROHYDRATE STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM SESQUICHLOROHYDRATE 200 mg/g 42913-012_aabfa5a6-3c4e-4aa5-8c32-b7ce495acfb3 42913-012 HUMAN OTC DRUG Soft Whisper by Power Stick Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20141121 OTC MONOGRAPH FINAL part358H A.P. Deauville, LLC PYRITHIONE ZINC 6 mg/mL 42914-001_66767af9-a49d-4441-b7ad-a2632aa5604c 42914-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20071215 UNAPPROVED MEDICAL GAS Aspen Air US Corp OXYGEN 99 L/100L 42914-010_73ec05a3-2685-4def-83ab-9602c73ede21 42914-010 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20071215 UNAPPROVED MEDICAL GAS Aspen Air US Corp NITROGEN 99 L/100L 42924-001_2b874be3-14ab-4446-bab6-acd45c64bd7c 42924-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090218 UNAPPROVED MEDICAL GAS Terjan Co., Inc. DBA Valley Welding Supply Company OXYGEN 990 mL/L 42924-002_5bfd9228-a248-46a0-9475-9999119bc62d 42924-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20100317 UNAPPROVED MEDICAL GAS Terjan Co., Inc. DBA Valley Welding Supply Company NITROGEN 990 mL/L 42926-010_d3353786-b3f3-45e9-be71-acffc2aaf54e 42926-010 HUMAN OTC DRUG LETTERS Lavender Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Mangiacotti Floral LLC ALCOHOL 62 mL/100mL 42926-020_d4f6cf50-6ae8-49dd-b34d-f8c5c6721526 42926-020 HUMAN OTC DRUG LETTERS Lemon Verbena Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Mangiacotti Floral LLC ALCOHOL 62 mL/100mL 42926-030_f4302837-a0e3-42e4-81c7-948e46c1f2af 42926-030 HUMAN OTC DRUG LETTERS Ocean Blue Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Mangiacotti Floral LLC ALCOHOL 62 mL/100mL 42926-110_f21b925d-df05-43c5-84fb-e960d33dae71 42926-110 HUMAN OTC DRUG Lemon Verbena Waterless Hand Wash ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Mangiacotti Floral LLC ALCOHOL 62 mL/100mL 42926-111_0126b9b7-f9b0-40e2-89d9-fd2a43be8e47 42926-111 HUMAN OTC DRUG Lemon Verbena Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120808 OTC MONOGRAPH NOT FINAL part333E Mangiacotti Floral LLC ALCOHOL 62 mL/100mL 42926-120_a33fbcd0-3836-4b2c-aa4c-4a44461bd0fe 42926-120 HUMAN OTC DRUG Ocean Waterless Hand Wash ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Mangiacotti Floral LLC ALCOHOL 62 mL/100mL 42926-121_ce3b356f-8344-4d33-beb7-158f5226ba3b 42926-121 HUMAN OTC DRUG Ocean Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120808 OTC MONOGRAPH NOT FINAL part333E Mangiacotti Floral LLC ALCOHOL 62 mL/100mL 42926-130_8a0d5fe0-4ae7-4260-891e-8b73a3f636ef 42926-130 HUMAN OTC DRUG Ginger Lime Waterless Hand Wash ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Mangiacotti Floral LLC ALCOHOL 62 mL/100mL 42926-131_d30f3bac-2ed7-4da1-a602-985a40304454 42926-131 HUMAN OTC DRUG Ginger Lime Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120808 OTC MONOGRAPH NOT FINAL part333E Mangiacotti Floral LLC ALCOHOL 62 mL/100mL 42926-140_58308110-cbe0-4f8a-b7a3-859428af56a3 42926-140 HUMAN OTC DRUG Lavender Waterless Hand Wash ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Mangiacotti Floral LLC ALCOHOL 62 mL/100mL 42926-141_78410fdf-5831-48ce-9d7e-4eb201fb8bd3 42926-141 HUMAN OTC DRUG Lavender Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120808 OTC MONOGRAPH NOT FINAL part333E Mangiacotti Floral LLC ALCOHOL 62 mL/100mL 42926-151_cbc5654b-a68e-4cea-9bf8-a0539a665675 42926-151 HUMAN OTC DRUG White Spruce Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120808 OTC MONOGRAPH NOT FINAL part333E Mangiacotti Floral LLC ALCOHOL 62 mL/100mL 42926-160_7bb257ee-6dee-4a8d-b205-ad2765b9feb8 42926-160 HUMAN OTC DRUG Pomegranate Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140514 OTC MONOGRAPH NOT FINAL part333E Mangiacotti, Inc BENZALKONIUM CHLORIDE 1 mg/mL 42926-161_f8b513e3-ab0b-48c7-a751-f1c98160cd50 42926-161 HUMAN OTC DRUG Ginger Lime hand sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140514 OTC MONOGRAPH NOT FINAL part333E Mangiacotti, Inc BENZALKONIUM CHLORIDE 1 mg/mL 42926-162_3505aedf-d91e-4184-85c0-0282f1f24f96 42926-162 HUMAN OTC DRUG Clementine Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140514 OTC MONOGRAPH NOT FINAL part333E Mangiacotti, Inc BENZALKONIUM CHLORIDE 1 mg/mL 42926-163_201c148a-466f-44d7-9c0a-27336a23f1ce 42926-163 HUMAN OTC DRUG Ocean Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140514 OTC MONOGRAPH NOT FINAL part333E Mangiacotti, Inc BENZALKONIUM CHLORIDE 1 mg/mL 42926-164_de33f9e6-5ff9-4739-992a-71c247f958e4 42926-164 HUMAN OTC DRUG Lavender Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140514 OTC MONOGRAPH NOT FINAL part333E Mangiacotti, Inc BENZALKONIUM CHLORIDE 1 mg/mL 42926-165_3d363eef-94f5-4c07-983a-b85664c9865a 42926-165 HUMAN OTC DRUG Lemon Verbena Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140514 OTC MONOGRAPH NOT FINAL part333E Mangiacotti, Inc BENZALKONIUM CHLORIDE 1 mg/mL 42936-585_cc152a2c-326a-4b98-b10d-c87c3c69a432 42936-585 HUMAN OTC DRUG Foam San Hand Sanitizer ALCOHOL LIQUID TOPICAL 20080605 OTC MONOGRAPH NOT FINAL part333E Hill Manufacturing Co., Inc. ALCOHOL .62 mL/mL 42937-701_578d1600-e1c1-4638-808b-54364af14137 42937-701 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, COATED ORAL 20110802 UNAPPROVED DRUG OTHER Nationwide Laboratories, LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 42937-702_578d1600-e1c1-4638-808b-54364af14137 42937-702 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, COATED ORAL 20110802 UNAPPROVED DRUG OTHER Nationwide Laboratories, LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 42937-703_9d53f29e-d218-480b-85ec-292842cdd4a4 42937-703 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20110819 UNAPPROVED DRUG OTHER Nationwide Laboratories, LLC SALSALATE 500 mg/1 42937-704_9d53f29e-d218-480b-85ec-292842cdd4a4 42937-704 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20110819 UNAPPROVED DRUG OTHER Nationwide Laboratories, LLC SALSALATE 750 mg/1 42937-706_affd4f2c-932e-48b3-8c4c-2783988bb000 42937-706 HUMAN PRESCRIPTION DRUG PreNatal 19 .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, and DOCUSATE SODIUM TABLET, COATED ORAL 20130601 UNAPPROVED DRUG OTHER Nationwide Laboratories, LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 30; 1000; 100; 200; 7; 400; 12; 25; 29; 1; 15; 20; 3; 3; 20 [iU]/1; [iU]/1; mg/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 42937-707_2b977d29-5b8f-48d9-bcfa-f5a9666a3ae4 42937-707 HUMAN PRESCRIPTION DRUG PreNatal 19 FOLIC ACID, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, and ZINC OXIDE TABLET, CHEWABLE ORAL 20130601 UNAPPROVED DRUG OTHER Nationwide Laboratories, LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 30; 1000; 100; 200; 7; 400; 12; 29; 1; 15; 20; 3; 3; 20 [iU]/1; [iU]/1; mg/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 42947-610_3285c92f-0faa-4a9c-a3be-d491c443ce55 42947-610 HUMAN OTC DRUG BZK Alcohol Benzalkonium Chloride SWAB TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory BENZALKONIUM CHLORIDE .0013 mL/mL 42947-611_e4be2e4a-9da9-4bce-8201-f62894a85256 42947-611 HUMAN OTC DRUG Povidone-Iodine Prep Pad Povidone-Iodine SWAB TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory POVIDONE-IODINE .1 mL/mL 42947-620_cfb71f6b-f8bd-43bb-a047-329778763926 42947-620 HUMAN OTC DRUG First Aid Antiseptic Benzalkonium Chloride SWAB TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory BENZALKONIUM CHLORIDE .0013 mL/mL 42947-621_1a90d4a5-023d-4627-b3ce-6aa0370786bc 42947-621 HUMAN OTC DRUG Povidone-Iodine Povidone-Iodine SWAB TOPICAL 20080101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory POVIDONE-IODINE .1 mL/mL 42947-630_4e328079-e975-4e4e-84c3-48d8a713c127 42947-630 HUMAN OTC DRUG Obstetrical Antiseptic Benzalkonium Chloride SWAB TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory BENZALKONIUM CHLORIDE .0013 mL/mL 42947-631_f3897610-a91c-49a7-901c-40a2896f9509 42947-631 HUMAN OTC DRUG Povidone-Iodine Povidone-Iodine SWAB TOPICAL 20080101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory POVIDONE-IODINE .1 mL/mL 42947-650_28502050-0f73-4cb1-9aaa-f682ee606ee6 42947-650 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory ISOPROPYL ALCOHOL .7 mL/mL 42947-650_589d1413-6e38-4174-be9e-7961647e0ae9 42947-650 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory ISOPROPYL ALCOHOL .7 mL/mL 42947-650_724b0f69-079a-4e42-bbee-85da828c5905 42947-650 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory ISOPROPYL ALCOHOL .7 mL/mL 42947-650_adb315dd-9271-4fbe-baa3-6c6148cebadf 42947-650 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory ISOPROPYL ALCOHOL .7 mL/mL 42952-101_613d8dc2-aebb-4d6b-8e7b-dd0071db0af3 42952-101 HUMAN OTC DRUG I-MAX EXCELLENCE AVOBENZONE OCTINOXATE OXYBENZONE LOTION TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part352 MAXLIFE USA, INC. AVOBENZONE; OCTINOXATE; OXYBENZONE 2.5; 7.5; 5 g/100mL; g/100mL; g/100mL 42952-201_db996b27-1fdf-4e56-93d2-6a0d3b6a79fe 42952-201 HUMAN OTC DRUG I-MAX LIGHTENING 5 HYDROQUINONE CREAM TOPICAL 20120918 OTC MONOGRAPH NOT FINAL part358A MAXLIFE USA, INC. HYDROQUINONE 2 g/100g 42952-203_b711e38c-61b2-484d-bfac-880abcf04e38 42952-203 HUMAN OTC DRUG I-MAX LIGHTENING L HYDROQUINONE CREAM TOPICAL 20120918 OTC MONOGRAPH NOT FINAL part358A MAXLIFE USA, INC. HYDROQUINONE 2 g/100g 42953-000_f7649670-7f8f-4d88-9ee6-6bd5b935996f 42953-000 HUMAN OTC DRUG DEFENDER Antiseptic Foam Hand BENZALKONIUM CHLORIDE SOAP TOPICAL 20121011 OTC MONOGRAPH FINAL part333E Scientific Molecular Technologies BENZALKONIUM CHLORIDE 1.3 mg/mL 42953-001_5e664169-6563-4036-b8f8-405785d15f73 42953-001 HUMAN OTC DRUG DEFENDER Foaming Hand Sanitizer ALCOHOL LIQUID TOPICAL 20121011 OTC MONOGRAPH FINAL part333E Scientific Molecular Technologies ALCOHOL 62 mL/100mL 42953-002_d2c15533-4c20-4229-a9e9-ab295e77753a 42953-002 HUMAN OTC DRUG DEFENDER Antiseptic Foam Hand Sanitizer Alcohol-Free BENZALKONIUM CHLORIDE LIQUID TOPICAL 20121011 OTC MONOGRAPH FINAL part333E Scientific Molecular Technologies BENZALKONIUM CHLORIDE 1.3 mg/mL 42957-001_a383bfe6-3a12-4fe6-aa0a-34c9c2cde13e 42957-001 HUMAN OTC DRUG BabySpa Shea Butter Diaper Zinc Oxide CREAM TOPICAL 20120718 UNAPPROVED DRUG OTHER EXPRO3 LLC ZINC OXIDE 120 mg/mL 42957-002_98405d64-9dc9-4dfd-9045-3bcdfacd360b 42957-002 HUMAN OTC DRUG BabySpa Calming Relief Eczema Colloidal Oatmeal CREAM TOPICAL 20130325 OTC MONOGRAPH FINAL part347 Expro3, LLC OATMEAL 1.25 g/125g 42961-001_83092338-8ba9-4dc3-867a-a96e52e9f8cf 42961-001 HUMAN OTC DRUG Antibacterial Foaming Hand Benzalkonium Chloride LIQUID TOPICAL 20080422 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. BENZALKONIUM CHLORIDE 1.25 mg/mL 42961-002_792ecca3-b456-4c45-b496-82ed841b6dd4 42961-002 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20080422 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. ALCOHOL 62 mL/100mL 42961-003_58ad86c2-7469-42f4-a899-5510ca5ec32f 42961-003 HUMAN OTC DRUG Foaming Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20080422 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. BENZALKONIUM CHLORIDE .1 mL/100mL 42961-004_b95ecd1a-f11f-4d9c-a734-a777fcccc3b7 42961-004 HUMAN OTC DRUG Food Service Soap Hand Soap LIQUID TOPICAL 20090701 OTC MONOGRAPH NOT FINAL part333 Cintas Corp. CHLOROXYLENOL 1 mL/100mL 42961-005_c5be1711-2654-481b-a7f1-0fa6f6ccae34 42961-005 HUMAN OTC DRUG Alcohol Foaming Hand Sanitizer Alcohol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. ALCOHOL 62 mL/100mL 42961-006_7a07a406-81c8-4df6-b02f-5c5bab6c3549 42961-006 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20100223 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. ALCOHOL 62 mL/100mL 42961-007_ce0dcfea-edb4-42fa-9869-cfd6b21a5e3e 42961-007 HUMAN OTC DRUG Antibacterial Spray Triclosan LIQUID TOPICAL 20100224 OTC MONOGRAPH NOT FINAL part333A Cintas Corp TRICLOSAN .5 mL/100mL 42961-008_9c2dcf91-0a69-4fa1-99c8-2f1bff0520d3 42961-008 HUMAN OTC DRUG Antibacterial Handsoap Chloroxylenol GEL TOPICAL 20100503 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. CHLOROXYLENOL 1 mL/100mL 42961-009_e3da00e6-079e-4710-a9e5-6ee789f5f57f 42961-009 HUMAN OTC DRUG Foaming Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part333A Cintas Corp BENZALKONIUM CHLORIDE 1 mg/mL 42961-010_1fd78aff-3c8e-4845-87ba-b883c69008bf 42961-010 HUMAN OTC DRUG Signature Antibacterial Foaming Hand BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131009 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. BENZALKONIUM CHLORIDE 1.25 mg/mL 42961-011_96156665-9afe-4937-96f6-89af577ae1f6 42961-011 HUMAN OTC DRUG Signature Antibacterial Foaming Hand BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140710 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. BENZALKONIUM CHLORIDE 1.2 mg/mL 42961-012_8e9f836e-2b61-4452-8b9d-deddd8061220 42961-012 HUMAN OTC DRUG Alcohol Foaming Hand Sanitizer ALCOHOL LIQUID TOPICAL 20140711 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. ALCOHOL 62 mL/100mL 42961-090_d38a90ce-4733-4abb-a2ac-8176273a6515 42961-090 HUMAN OTC DRUG fad first aid direct Eyewash purified water SOLUTION CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL 20140715 OTC MONOGRAPH FINAL part349 Cintas Corporation WATER 985.77 g/1000mL 42961-091_d38a90ce-4733-4abb-a2ac-8176273a6515 42961-091 HUMAN OTC DRUG Xpect First aid Buffered Eyewash purified water SOLUTION CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL 20140715 OTC MONOGRAPH FINAL part349 Cintas Corporation WATER 985.77 g/1000mL 42961-092_d38a90ce-4733-4abb-a2ac-8176273a6515 42961-092 HUMAN OTC DRUG Eyewash Flushing Solution purified water SOLUTION CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL 20140715 OTC MONOGRAPH FINAL part349 Cintas Corporation WATER 985.77 g/1000mL 42961-093_d38a90ce-4733-4abb-a2ac-8176273a6515 42961-093 HUMAN OTC DRUG Xpect First aid Buffered Eye and Skin purified water SOLUTION CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL 20140715 OTC MONOGRAPH FINAL part349 Cintas Corporation WATER 985.77 g/1000mL 42961-094_d38a90ce-4733-4abb-a2ac-8176273a6515 42961-094 HUMAN OTC DRUG fad first aid direct Buffered Eye and Skin purified water SOLUTION CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL 20140715 OTC MONOGRAPH FINAL part349 Cintas Corporation WATER 985.77 g/1000mL 42961-124_0bddba0a-eade-47da-8373-fcb10d723b62 42961-124 HUMAN OTC DRUG Antacid Fruit Flavor Antacid TABLET ORAL 20140619 OTC MONOGRAPH FINAL part331 Cintas CALCIUM CARBONATE 500 mg/1 42961-159_535a0f0c-0ceb-47cb-99b3-77c90a55a859 42961-159 HUMAN OTC DRUG theSafetyDirector aquapreserv purified water SOLUTION, CONCENTRATE CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL 20140715 OTC MONOGRAPH FINAL part349 Cintas Corporation WATER 992.96 g/1000mL 42961-235_0272690e-0a82-41b7-a27a-3b5b860c55bc 42961-235 HUMAN OTC DRUG Acetaminophen Maximum Strength Acetaminophen TABLET ORAL 20141120 OTC MONOGRAPH NOT FINAL part343 CINTAS ACETAMINOPHEN 500 mg/1 42961-300_934f43bb-4712-4ac4-87ee-d3969c4b63c1 42961-300 HUMAN OTC DRUG First Aid Direct Buffered Eyewash Sterile Isotonic Water SOLUTION OPHTHALMIC 20111001 OTC MONOGRAPH FINAL part349 Cintas WATER .98 mL/mL 42961-301_c9f59698-8a6c-47e1-b5a8-b543f2ece863 42961-301 HUMAN OTC DRUG Xpect Buffered Eyewash Sterile Isotonic Water SOLUTION OPHTHALMIC 20111001 OTC MONOGRAPH FINAL part349 Cintas WATER .98 mL/mL 42961-504_35fe8dc4-5973-4b82-b83a-35d2c99c9fa6 42961-504 HUMAN OTC DRUG ALCOHOL WIPE ISOPROPYL ALCOHOL SWAB TOPICAL 20140225 OTC MONOGRAPH FINAL part344 Cintas Corporation ISOPROPYL ALCOHOL .7 g/mL 42976-121_ed3eaf69-1cbd-4b01-a6fa-1fe02c90c3e1 42976-121 HUMAN PRESCRIPTION DRUG ATryn Antithrombin (Recombinant) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090506 BLA BLA125284 GTC Biotherapeutics, Inc. ANTITHROMBIN ALFA 1750 [iU]/1 Recombinant Antithrombin [EPC],Decreased Coagulation Factor Activity [PE],Thrombin Inhibitors [MoA],Factor Xa Inhibitors [MoA] 42979-100_083dc305-9c3c-4ccb-bd54-81cf4b3e3be6 42979-100 HUMAN OTC DRUG HES CLEAN ALCOHOL GEL TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333E DOCTOR C&C CO., LTD. ALCOHOL 6 mL/200mL 42979-110_d4f4bcf1-b714-43bd-9767-d0963f23ffd4 42979-110 HUMAN OTC DRUG HES CLEAN PLUS ALCOHOL GEL TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part333E DOCTOR C&C CO., LTD. ALCOHOL 4 mg/50mL 42979-120_06874f7f-f609-4afd-91aa-ddb96f70ecff 42979-120 HUMAN OTC DRUG HES CLEAN ADAM Alcohol GEL TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part333E DOCTOR C&C ALCOHOL 5.4 mg/180mL 42979-130_fcd7b31b-9d3a-4325-a44e-f5ad66657019 42979-130 HUMAN OTC DRUG HES CLEAN EVE Alcohol GEL TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part333E DOCTOR C&C ALCOHOL 1.8 mg/180mL 42979-140_a56416f5-5645-40ba-b437-9c4c90760706 42979-140 HUMAN OTC DRUG HES CLEAN FOR WOMAN Alcohol SOLUTION TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part333E DOCTOR C&C ALCOHOL 1.8 mg/180mL 42982-4441_c250f55d-211a-450b-ae6d-59cbc9854848 42982-4441 HUMAN OTC DRUG Bekunis Natures Gentle Stimulant Laxative SENNOSIDES A AND B TABLET, SUGAR COATED ORAL 20110210 OTC MONOGRAPH NOT FINAL part334 roha arzneimittel GmbH SENNOSIDES A AND B 20 mg/1 42982-4451_e4967721-b5b0-43b4-8c42-a58b45b6ce4a 42982-4451 HUMAN OTC DRUG Bekunis Natures Gentle Laxative Instant Tea SENNOSIDES POWDER ORAL 20110321 OTC MONOGRAPH NOT FINAL part334 roha arzneimittel GmbH SENNOSIDES A AND B 20 mg/.5g 42982-4461_ccf5985f-7661-4602-99f3-2b623332f440 42982-4461 HUMAN OTC DRUG Bekunis Natures Gentle Laxative Herbal Tea SENNOSIDES EXTRACT ORAL 20110321 OTC MONOGRAPH NOT FINAL part334 roha arzneimittel GmbH SENNOSIDES A AND B 23 mg/g 42998-203_fbef307e-deda-4292-98d9-27dfa0f624b0 42998-203 HUMAN PRESCRIPTION DRUG Opium Tincture Deodorized Morphine SOLUTION ORAL 20080917 UNAPPROVED DRUG OTHER Marathon Pharmaceuticals, LLC MORPHINE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 42998-302_0f10fdfc-c161-4e05-bd41-2d5080ecf02f 42998-302 HUMAN PRESCRIPTION DRUG Nitropress SODIUM NITROPRUSSIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20131201 ANDA ANDA071961 Marathon Pharmaceuticals, LLC SODIUM NITROPRUSSIDE 50 mg/2mL 42998-303_f38ab4b0-220f-4175-a11b-c5703a5d8716 42998-303 HUMAN PRESCRIPTION DRUG Amytal Sodium amobarbital sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080925 UNAPPROVED DRUG OTHER Marathon Pharmaceuticals, LLC AMOBARBITAL SODIUM .5 g/5mL CII 42998-402_05824850-3c5c-4130-81b9-21582c516911 42998-402 HUMAN PRESCRIPTION DRUG Isuprel ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20131201 NDA NDA010515 Marathon Pharmaceuticals, LLC ISOPROTERENOL HYDROCHLORIDE .2 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 42998-639_19bd3d6f-0b09-4c7c-b6dc-d59b383ac8b4 42998-639 HUMAN PRESCRIPTION DRUG Pepcid famotidine TABLET, FILM COATED ORAL 19861015 NDA NDA019462 Marathon Pharmaceuticals, LLC FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 42998-649_19bd3d6f-0b09-4c7c-b6dc-d59b383ac8b4 42998-649 HUMAN PRESCRIPTION DRUG Pepcid famotidine TABLET, FILM COATED ORAL 19861015 NDA NDA019462 Marathon Pharmaceuticals, LLC FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 42998-679_0894e313-a283-4a4a-a1e2-7ca91ddb68f8 42998-679 HUMAN PRESCRIPTION DRUG Seconal Sodium secobarbital sodium CAPSULE ORAL 19831003 ANDA ANDA086101 Marathon Pharmaceuticals, LLC SECOBARBITAL SODIUM 100 mg/1 CII 42998-715_97252910-5348-4dd1-b962-08487b3e1dc6 42998-715 HUMAN PRESCRIPTION DRUG Iprivask desirudin KIT SUBCUTANEOUS 20131231 NDA NDA021271 Marathon Pharmaceuticals, LLC 42998-963_dfdb7f97-ad08-41f7-8480-76073c124195 42998-963 HUMAN PRESCRIPTION DRUG Pepcid famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 Marathon Pharmaceuticals, LLC FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 42998-964_dfdb7f97-ad08-41f7-8480-76073c124195 42998-964 HUMAN PRESCRIPTION DRUG Pepcid famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 Marathon Pharmaceuticals, LLC FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 42998-973_574a879b-a659-4c89-969b-53585e792d84 42998-973 HUMAN PRESCRIPTION DRUG Pepcid Famotidine TABLET, FILM COATED ORAL 20140527 ANDA ANDA075805 Marathon Pharmaceuticals FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 42998-974_574a879b-a659-4c89-969b-53585e792d84 42998-974 HUMAN PRESCRIPTION DRUG Pepcid Famotidine TABLET, FILM COATED ORAL 20140527 ANDA ANDA075805 Marathon Pharmaceuticals FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 43063-007_57c177b8-b876-4cd0-b034-645e4b0cebed 43063-007 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 43063-010_18e81d13-d186-4e6f-b9a0-cce70c86c2e7 43063-010 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43063-012_38f9865a-1af6-4aa4-8df8-c1acb8b15c85 43063-012 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20120427 ANDA ANDA077880 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43063-013_49054a7c-158d-4aad-89ba-b68809d89aaf 43063-013 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 PD-Rx Pharmaceuticals, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-014_93430801-d363-4fc7-a27d-f84b9154d2f2 43063-014 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 43063-015_5846a01b-894e-4587-8fd0-39c07b8b27eb 43063-015 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20070301 ANDA ANDA065291 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43063-016_a6042cd7-816f-4804-b254-c5bdd88474e3 43063-016 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060201 ANDA ANDA065215 PD-Rx Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 43063-017_2a989bfd-f214-4e3f-a311-e1717bebec25 43063-017 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20070301 ANDA ANDA065291 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43063-018_7c32978c-1115-4907-a372-1919b2cb9e32 43063-018 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071135 PD-Rx Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43063-019_6bfb01d5-8129-4663-bfdf-adfdb6cda887 43063-019 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840507 ANDA ANDA062396 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 43063-020_c287cede-968f-40b4-95b9-bf477842d921 43063-020 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20110923 ANDA ANDA073192 PD-Rx Pharmaceuticals, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 43063-021_437f1a69-02cd-4c30-9e3d-954fe9942a4e 43063-021 VACCINE Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070033 PD-Rx Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 43063-023_b8be83f6-b41a-48d7-8bf8-a2a7a7facff3 43063-023 HUMAN PRESCRIPTION DRUG Propoxyphene and Acetaminophen propoxyphene napsylate and acetaminophen TABLET, FILM COATED ORAL 20100510 ANDA ANDA074843 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 650; 100 1/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 43063-024_d55ea8e1-40ba-4939-9d84-313ae66409bc 43063-024 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 PD-Rx Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 43063-025_d6053a67-15d3-4997-982d-954d4ba69413 43063-025 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040777 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-028_15c6592e-2f99-4aba-bb59-057953409ce3 43063-028 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 PD-Rx Pharmaceuticals, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 43063-030_1e1b7f3b-ff71-4a69-bc2a-625f91aa5501 43063-030 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium clorazepate dipotassium TABLET ORAL 20100729 ANDA ANDA071858 PD-Rx Pharmaceuticals, Inc. CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43063-034_649c183e-9b7c-4e94-90c1-d34eab2860dd 43063-034 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 PD-Rx Pharmaceuticals, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 43063-036_54961469-5084-488c-b69d-b640133f8b2e 43063-036 HUMAN PRESCRIPTION DRUG Ketoconazole ketoconazole TABLET ORAL 20110520 ANDA ANDA075597 PD-Rx Pharmaceuticals, Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 43063-038_ac2de360-6efc-4a98-9a37-3d7aa1bdb0cf 43063-038 HUMAN PRESCRIPTION DRUG Comfort Pac with Ibuprofen Ibuprofen KIT 20120906 ANDA ANDA078558 PD-Rx Pharmaceuticals, Inc. 43063-045_8858e194-54a1-4cec-b57f-93411ebf6a52 43063-045 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19860730 ANDA ANDA085223 PD-Rx Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 43063-046_708a5f1d-a59e-47a1-938a-540f36fc5126 43063-046 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20101206 ANDA ANDA084769 PD-Rx Pharmaceuticals, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43063-047_8c32b4ac-fe0d-458a-8d91-03a68a8f0cba 43063-047 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060201 ANDA ANDA065215 PD-Rx Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 43063-048_7ab43d5d-661f-4629-99a2-3b706325e141 43063-048 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 PD-Rx Pharmaceuticals, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43063-049_7a1c8f10-0813-4c84-b055-35a26ad122a3 43063-049 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20080212 ANDA ANDA040724 PD-Rx Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 43063-050_a00ba320-5cc2-4c65-95ce-543860678746 43063-050 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100218 ANDA ANDA078218 PD-Rx Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 43063-051_abe15d1d-b498-4b1f-857f-1ffcd86b6551 43063-051 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA078439 PD-Rx Pharmaceuticals, Inc. HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-052_87d5c4c6-100d-445c-b681-f0734a1b9eec 43063-052 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 PD-Rx Pharmaceuticals, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 43063-053_89f3888b-9874-4b8e-8811-fddae14b930d 43063-053 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 PD-Rx Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 43063-054_37f15396-1150-47f6-9a0c-ac29e9887580 43063-054 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062936 PD-Rx Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 250 mg/1 43063-055_7417417e-df11-498d-a36a-cdf57ee36c41 43063-055 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 PD-Rx Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 43063-056_fc067420-2843-475c-a1aa-106a97232bf8 43063-056 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 19910731 ANDA ANDA063083 PD-Rx Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 43063-057_5786ed8b-566b-4dcd-982d-1dd13e2cd8ce 43063-057 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072926 PD-Rx Pharmaceuticals, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43063-059_f9dcfef0-b9a9-4ed2-89b4-bb92c82b97e1 43063-059 HUMAN PRESCRIPTION DRUG TERBUTALINE SULFATE TERBUTALINE SULFATE TABLET ORAL 20010626 ANDA ANDA075877 PD-Rx Pharmaceuticals, Inc. TERBUTALINE SULFATE 5 mg/1 43063-060_9242d76a-f7d9-4d50-bd68-ed5b4cd96722 43063-060 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20060517 ANDA ANDA040500 PD-Rx Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 43063-061_8537b2a9-973f-4891-b1e4-b60eaeaec031 43063-061 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20091231 ANDA ANDA074215 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43063-062_9e8e6ec5-68eb-472c-a2d3-71487c4205b3 43063-062 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073025 PD-Rx Pharmaceuticals, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43063-063_cc2d8a74-2613-4d93-b0ef-572348d807c8 43063-063 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100913 ANDA ANDA077289 PD-Rx Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-064_1a4c6120-c126-4ff1-84e7-f9d5c879a963 43063-064 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19940527 ANDA ANDA074217 PD-Rx Pharmaceuticals, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43063-065_8e372054-6344-43c6-bb0e-27663fd51488 43063-065 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43063-068_8f4fb8b4-ea86-4db2-ab28-365fbfcdae48 43063-068 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20101210 ANDA ANDA076578 PD-Rx Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 43063-072_5a5dcab0-2271-4160-8540-e4b1b9d9c540 43063-072 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20100802 ANDA ANDA091426 PD-Rx Pharmaceuticals, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 43063-075_a3db42de-db2b-439d-901c-54e054ff2bfe 43063-075 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 PD-Rx Pharmaceuticals, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 43063-077_91706401-82d2-471d-a2fa-6e079ed02eeb 43063-077 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20110125 ANDA ANDA065096 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 43063-079_8a328955-185a-47ef-8070-58f0ff664b61 43063-079 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 PD-Rx Pharmaceuticals, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 43063-080_51fcc4f7-9d14-41e3-bc69-c053e743f49f 43063-080 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43063-085_af6b71a5-1315-4309-8f14-7d6443b6ea0f 43063-085 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077068 PD-Rx Pharmaceuticals, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 43063-086_d85a968f-7d48-4d18-a1b1-b970b0abd6b9 43063-086 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20110211 ANDA ANDA075511 PD-Rx Pharmaceuticals, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 43063-087_7f7ede0c-1f51-443c-97aa-177cf8efca8f 43063-087 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 PD-Rx Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 43063-088_c0ef68b9-c438-4831-9d6c-85298decd714 43063-088 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20110907 ANDA ANDA074215 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43063-089_b629a40d-9860-4107-9533-7aaa1dc62ffe 43063-089 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 PD-Rx Pharmaceuticals, Inc. ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 43063-090_835e8839-80f4-45aa-9989-9fa173195d9f 43063-090 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 PD-Rx Pharmaceuticals, Inc. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 43063-091_a3bded10-411b-49d4-a763-f6239616a094 43063-091 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 43063-092_4e9cf21e-b06a-4f20-a1fb-414debcefdfe 43063-092 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040114 ANDA ANDA076494 PD-Rx Pharmaceuticals, Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-094_82333b89-f5ef-4785-a00d-c8364787326a 43063-094 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43063-095_805a2d06-3fad-482c-8a71-1e59bddd752f 43063-095 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20070629 ANDA ANDA040808 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 43063-096_679bff9b-f227-40ad-a387-26fdc93aeff0 43063-096 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062935 PD-Rx Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 43063-097_efbb0388-53fc-4293-8b79-c31478b99ec0 43063-097 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 PD-Rx Pharmaceuticals, Inc. PREDNISONE 20 mg/1 43063-108_010f468e-2ace-4ea4-9278-a26b6aabd5ca 43063-108 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070027 PD-Rx Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 43063-109_a0dcf3de-9cf2-471a-a53c-d93054704f3a 43063-109 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19851204 ANDA ANDA088832 PD-Rx Pharmaceuticals, Inc. PREDNISONE 10 mg/1 43063-110_68116132-64d9-4c00-9f62-ad4ddd5bfbeb 43063-110 HUMAN PRESCRIPTION DRUG E.E.S. Erythromycin Ethylsuccinate TABLET, FILM COATED ORAL 20101216 ANDA ANDA061905 PD-Rx Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 400 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 43063-111_21614d33-2df0-4bd7-b1da-5e6c90fd861c 43063-111 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 PD-Rx Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 43063-112_265e92ae-de25-41a3-8185-721fb07e4022 43063-112 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 PD-Rx Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 43063-113_49ce60ed-d2e5-44a5-b52d-7fc8467ba8aa 43063-113 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 43063-114_7390ff90-47e5-4b76-b028-f2a36af2bd7a 43063-114 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43063-118_5c554edd-b7ac-4b7d-801d-1a7c00fbd3e7 43063-118 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43063-119_73324ce4-a1a9-45a0-ad5f-3d03383793d8 43063-119 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 20110628 ANDA ANDA074792 PD-Rx Pharmaceuticals, Inc. GLYBURIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 43063-120_c2df9b65-1541-4522-8322-b43a3f5bae3c 43063-120 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 20110628 ANDA ANDA074792 PD-Rx Pharmaceuticals, Inc. GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 43063-121_821ca40a-d472-4690-b0d8-432b9913ab1e 43063-121 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 PD-Rx Pharmaceuticals, Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 43063-122_f6c83a48-c976-48e5-a036-afae3d3bf1d8 43063-122 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 PD-Rx Pharmaceuticals, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 43063-126_c2bd1c17-1d09-4431-beba-6d506919037b 43063-126 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 PD-Rx Pharmaceuticals, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 43063-127_4105e0ef-facf-4e65-8164-d801754dc428 43063-127 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 PD-Rx Pharmaceuticals, Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 43063-129_756f1d80-8fa6-46c4-8554-a77618604dfe 43063-129 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 PD-Rx Pharmaceuticals, Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 43063-130_c3dad3f5-f6d2-4db2-811f-210655df285d 43063-130 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20100804 ANDA ANDA075776 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43063-131_56f893c7-2d0f-4c77-916a-a097faef2a73 43063-131 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20110929 ANDA ANDA076211 PD-Rx Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 43063-132_a05a0fb2-c797-4dfb-b7a1-9cb5fa7ae61b 43063-132 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 PD-Rx Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 43063-133_4b9b1c96-901d-4284-a43d-a7409e555293 43063-133 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20000501 ANDA ANDA075366 PD-Rx Pharmaceuticals, Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 43063-134_bb904d2e-9e55-4e8c-bdb6-82208ef32adb 43063-134 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20111003 ANDA ANDA075768 PD-Rx Pharmaceuticals, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43063-138_9018e5b6-4b12-4348-923e-53a9c5b4fd87 43063-138 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020702 ANDA ANDA075944 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 2.5 mg/1 43063-139_608d08b0-6a4e-412a-b82f-4341fac5f473 43063-139 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN and CODEINE ACETAMINOPHEN and CODEINE SOLUTION ORAL 20100101 ANDA ANDA040746 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL CV 43063-142_0d2db84b-5c4d-4cfb-953d-654f669e2b84 43063-142 HUMAN PRESCRIPTION DRUG Pentazocine and naloxone Pentazocine hydrochloride and naloxone hydrochloride TABLET ORAL 20100101 ANDA ANDA074736 PD-Rx Pharmaceuticals, Inc. NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE .5; 50 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIV 43063-143_6515f2d8-dcca-42d1-b16e-602f3f58499b 43063-143 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20091231 ANDA ANDA076714 PD-Rx Pharmaceuticals, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43063-145_d7a783b7-1894-4a19-b4ad-f9d20da2f85f 43063-145 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 19971031 ANDA ANDA075079 PD-Rx Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 43063-146_435f79a7-c085-40e5-a2f7-2870dc6195e5 43063-146 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 20110504 ANDA ANDA074434 PD-Rx Pharmaceuticals, Inc. CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 43063-147_81bdaa55-49e8-4a2d-8ce6-26266b157a09 43063-147 HUMAN PRESCRIPTION DRUG Methergine methylergonovine maleate TABLET, COATED ORAL 19461119 NDA NDA006035 PD-Rx Pharmaceuticals, Inc. METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 43063-160_5d7cb4bd-9a60-4809-abcb-7e7b5a9cce0f 43063-160 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20101213 ANDA ANDA040185 PD-Rx Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 43063-164_03ac696d-1d2c-4bc2-b25f-4b97ad27d2e8 43063-164 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium clorazepate dipotassium TABLET ORAL 20100729 ANDA ANDA071858 PD-Rx Pharmaceuticals, Inc. CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43063-170_4351ba8f-fff8-43e9-8993-1b4a65ff5319 43063-170 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20130204 ANDA ANDA078902 PD-Rx Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-171_fcd2aadd-c236-4d8d-aa57-7cb1b895c581 43063-171 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 43063-172_b12ca138-2dfa-461a-8ea2-f10a00941f89 43063-172 HUMAN PRESCRIPTION DRUG hydoxyzine pamoate hydoxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA087479 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 43063-173_96bba317-77a9-42f7-8a00-24b67d25b8d2 43063-173 HUMAN PRESCRIPTION DRUG Nitrofurantoin nitrofurantoin CAPSULE ORAL 20110506 ANDA ANDA074967 PD-Rx Pharmaceuticals, Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 43063-174_0da6f122-92ec-4282-a423-ca28d60ddbf7 43063-174 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20100915 ANDA ANDA074761 PD-Rx Pharmaceuticals, Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-177_b1abd90a-8dcc-4c2f-a3d0-38309fd300ba 43063-177 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 43063-178_011adecc-2994-4eed-939f-f6b926c10724 43063-178 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 43063-180_49aca9d9-27ee-4415-8e9a-8c8994d515e5 43063-180 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 20110120 ANDA ANDA062286 PD-Rx Pharmaceuticals, Inc. DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43063-182_5b5750e7-ae4f-412e-bf1b-2310402a5aa2 43063-182 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120815 ANDA ANDA040887 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 43063-183_83d971d4-47e1-4b1b-bba2-e0d25c53308e 43063-183 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 PD-Rx Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 43063-184_acade20a-6cf6-4490-a7fd-fd930172f695 43063-184 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride, naloxone hydrochloride TABLET SUBLINGUAL 20111110 NDA NDA020733 PD-Rx Pharmaceuticals, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 43063-186_9d93bbf3-5f58-49d2-be21-53cbd7d6e9c0 43063-186 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 PD-Rx Pharmaceuticals, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 43063-188_b1667bd5-1dfb-4cfa-845e-1f401c9106cc 43063-188 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, EXTENDED RELEASE ORAL 20101115 ANDA ANDA075028 PD-Rx Pharmaceuticals, Inc. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 43063-189_f63d094a-4e75-436c-8fca-822e7ad6a02b 43063-189 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43063-190_f176c516-e0bc-411c-959c-0773c00b5140 43063-190 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20090903 ANDA ANDA070317 PD-Rx Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 43063-191_bec72279-9972-43ba-ab22-8bfc5a80f314 43063-191 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 43063-193_9b7c4a24-b4d4-43cf-8711-066e2617631a 43063-193 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 PD-Rx Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 43063-194_478954c4-aa48-49ff-a680-f756d95182bd 43063-194 HUMAN PRESCRIPTION DRUG CEFACLOR CEFACLOR CAPSULE ORAL 20070501 ANDA ANDA065350 PD-Rx Pharmaceuticals, Inc. CEFACLOR 500 mg/1 43063-195_8e9db9a7-4782-4c3d-855d-d8bb7b4069e4 43063-195 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20091231 ANDA ANDA076714 PD-Rx Pharmaceuticals, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43063-196_5abdfe59-f756-4142-a35f-434eaeaa4777 43063-196 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20030301 ANDA ANDA076243 PD-Rx Pharmaceuticals, Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 43063-197_1cba5127-d435-47cc-831b-a044a885ad63 43063-197 HUMAN PRESCRIPTION DRUG FLUOXETINE fluoxetine hydrochloride CAPSULE ORAL 20081208 ANDA ANDA076922 PD-Rx Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-200_af488e25-aae5-4f6d-8d5d-0b318e592dce 43063-200 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20070131 ANDA ANDA076588 PD-Rx Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 43063-201_394d160a-3b69-4982-b386-11c3ae4f717b 43063-201 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 PD-Rx Pharmaceuticals, Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 43063-202_3ca0df2e-0b81-4551-9ed1-a09267c51543 43063-202 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20090127 ANDA ANDA078947 PD-Rx Pharmaceuticals, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 43063-203_e5975a79-a339-4249-9bbb-4b634c4a9ded 43063-203 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20090127 ANDA ANDA078947 PD-Rx Pharmaceuticals, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 43063-204_5ade699f-fc43-408f-9a12-fba939ed5056 43063-204 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir CAPSULE ORAL 20100323 ANDA ANDA074727 PD-Rx Pharmaceuticals, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 43063-205_b3db9756-8bc4-462c-ad0d-13f47e84cc7d 43063-205 HUMAN PRESCRIPTION DRUG Zipsor diclofenac potassium CAPSULE, LIQUID FILLED ORAL 20100430 NDA NDA022202 PD-Rx Pharmaceuticals, Inc. DICLOFENAC POTASSIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-207_4f56ed3f-5679-4b24-9f61-a9feb6388bf9 43063-207 HUMAN PRESCRIPTION DRUG R-Tanna Phenylephrine Tannate and Chlorpheniramine Tannate TABLET ORAL 20051019 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. CHLORPHENIRAMINE TANNATE; PHENYLEPHRINE TANNATE 9; 25 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 43063-208_c226875b-d32d-4a13-b449-ad4a94195ca9 43063-208 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20070716 ANDA ANDA040761 PD-Rx Pharmaceuticals, Inc. HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43063-209_7c3e29d4-983b-4e79-b590-fd1663d2204c 43063-209 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20100118 ANDA ANDA076187 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 43063-210_c35adb4c-7ee3-4d6b-b32e-6b514dae4683 43063-210 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20110721 NDA NDA019962 PD-Rx Pharmaceuticals, Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43063-211_a77e9903-c90c-461d-bc3d-00b12729ba0f 43063-211 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20110721 NDA NDA019962 PD-Rx Pharmaceuticals, Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43063-212_c8e46788-61aa-49e5-b0bb-f2b0c6cb7b9c 43063-212 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 PD-Rx Pharmaceuticals, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 43063-213_4fb8dafc-4603-40e6-8c5d-37cea682d688 43063-213 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA AUTHORIZED GENERIC NDA019839 PD-Rx Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-214_1072dff9-daee-4dcc-930f-be3c6e386227 43063-214 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA AUTHORIZED GENERIC NDA019839 PD-Rx Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-216_f76f7c24-0a6f-4ade-99ec-26f531422300 43063-216 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20010802 ANDA ANDA075049 PD-Rx Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-217_d8dc77f4-d42f-4a5c-a4f7-cb001e6e3560 43063-217 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20100101 ANDA ANDA070791 PD-Rx Pharmaceuticals, Inc. DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 43063-218_6d027d1f-7001-4ac0-8494-1137dfa0898f 43063-218 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20100329 ANDA ANDA040145 PD-Rx Pharmaceuticals, Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 43063-219_3498dde4-855d-4eaf-bbbd-0b16b2d81456 43063-219 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20100101 ANDA ANDA077712 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-220_1d74c28d-2dd9-4783-8cde-c2206f231c2e 43063-220 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20100101 ANDA ANDA077712 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-221_be19e0ca-b6b0-4ef0-ae57-e02718b9724e 43063-221 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20041112 ANDA ANDA077032 PD-Rx Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-222_7cca2a20-4107-4398-9877-47d2884b5b6e 43063-222 HUMAN PRESCRIPTION DRUG DOLOPHINE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20100101 NDA NDA006134 PD-Rx Pharmaceuticals, Inc. METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-223_e6aa94c8-aa5c-4e17-b95d-d6b47be425cb 43063-223 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43063-225_f94091aa-1ed9-463a-92a5-71136ae0af11 43063-225 HUMAN PRESCRIPTION DRUG Primaquine Phosphate Primaquine Phosphate TABLET ORAL 20100101 ANDA ANDA008316 PD-Rx Pharmaceuticals, Inc. PRIMAQUINE PHOSPHATE 26.3 mg/1 Antimalarial [EPC] 43063-228_469fcc0f-5813-4fcc-87ae-773130d936a2 43063-228 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20100101 ANDA ANDA080693 PD-Rx Pharmaceuticals, Inc. HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43063-230_7f334265-0fd1-40bc-9f92-529a875c8bfc 43063-230 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20100118 ANDA ANDA076187 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 43063-231_66713426-d736-4bf2-9878-c655dc9a4902 43063-231 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20100101 ANDA ANDA040535 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-232_3abb5ecf-8000-41ca-aa98-2b3b4be7bea4 43063-232 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 43063-233_9ec75fd5-2afd-41a8-b508-8f74ee20f8b1 43063-233 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 43063-234_2a9a6abe-2d64-45d8-9da0-bccbe9d5486f 43063-234 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 43063-235_34de129f-057d-49e3-82da-f117d74499be 43063-235 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20100118 ANDA ANDA076187 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 43063-236_ac34f5f8-ca50-47d9-bb9a-f8b28df86ae7 43063-236 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 PD-Rx Pharmaceuticals, Inc. TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 43063-237_43c28b5d-cb69-4b40-90d0-c76b594bd1a3 43063-237 HUMAN PRESCRIPTION DRUG Comfort Pac with Tizanidine Tizanidine KIT 20130709 ANDA ANDA076280 PD-Rx Pharmaceuticals, Inc. 43063-238_ae6996f4-0fc7-4c0b-b5db-273af4061ead 43063-238 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20090127 ANDA ANDA078947 PD-Rx Pharmaceuticals, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 43063-239_765914ff-456e-460e-8374-34c7f8c660a1 43063-239 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 PD-Rx Pharmaceuticals, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 43063-240_ec7a1474-268d-4576-a027-76eb44129778 43063-240 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20111202 ANDA ANDA077238 PD-Rx Pharmaceuticals, Inc. ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 43063-242_31dd82d6-7415-4ab7-ae06-87f6468af63b 43063-242 HUMAN PRESCRIPTION DRUG NAPRELAN naproxen sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081219 NDA NDA020353 PD-Rx Pharmaceuticals, Inc. NAPROXEN SODIUM 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-243_55aa62f0-bbf5-4be7-a567-fb1f80abeff6 43063-243 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 PD-Rx Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 43063-244_e596b97a-2812-4999-9836-83f70eebc210 43063-244 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970101 NDA NDA020553 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-245_db7588a6-b912-4b64-b9d0-f5cbb79285f5 43063-245 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19951201 NDA NDA020553 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-246_d810d964-eb39-46b8-a3d6-cb5cf67fa9c3 43063-246 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19951201 NDA NDA020553 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-247_2a4b2133-7b49-4bbc-a268-1dbf314b847d 43063-247 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 PD-Rx Pharmaceuticals, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 43063-248_84f5e8aa-a8b9-4101-8f73-c2974a92522f 43063-248 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20100210 ANDA ANDA072575 PD-Rx Pharmaceuticals, Inc. PRAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 43063-249_6b07427f-073a-4a16-86a2-3c35938e2e26 43063-249 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20041112 ANDA ANDA077032 PD-Rx Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-250_7c88e727-566c-47ea-9bb0-76b52e2d987f 43063-250 HUMAN PRESCRIPTION DRUG clomiphene citrate clomiphene citrate TABLET ORAL 19670201 NDA NDA016131 PD-Rx Pharmaceuticals, Inc. CLOMIPHENE CITRATE 50 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 43063-251_bf7d9740-2e8a-44df-a77d-bb8f24576b0c 43063-251 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20110901 ANDA ANDA088488 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 100 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 43063-252_576c08ff-d694-4664-843a-2df52f452961 43063-252 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 PD-Rx Pharmaceuticals, Inc. LIOTHYRONINE SODIUM 50 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 43063-253_03417dc1-7c7c-48ae-b335-fb34756dfec6 43063-253 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 PD-Rx Pharmaceuticals, Inc. LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 43063-254_27872b7c-3530-438c-b9d1-a41feb0ef79b 43063-254 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 PD-Rx Pharmaceuticals, Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 43063-255_1bb78322-d112-4a93-9d90-10e70cda0614 43063-255 HUMAN PRESCRIPTION DRUG mirtazapine mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076219 PD-Rx Pharmaceuticals, Inc. MIRTAZAPINE 30 mg/1 43063-256_782ebeed-1bb7-40a5-830a-a69087fd823d 43063-256 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 PD-Rx Pharmaceuticals, Inc. SILDENAFIL CITRATE 25 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 43063-257_8cd2dd6e-40ca-4e4c-a2a3-a7b2f4224333 43063-257 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 20090806 ANDA ANDA074947 PD-Rx Pharmaceuticals, Inc. CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 43063-258_df43f3a8-a58f-4225-a730-d6d23c339415 43063-258 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100422 ANDA ANDA074121 PD-Rx Pharmaceuticals, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-259_69467299-b152-4653-912b-22fc0555bb64 43063-259 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20090127 ANDA ANDA078947 PD-Rx Pharmaceuticals, Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 43063-260_f89ed9c6-2a7e-403a-a508-85afbbaa1ce4 43063-260 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20100210 ANDA ANDA072575 PD-Rx Pharmaceuticals, Inc. PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 43063-261_f68fe3fa-e937-4681-815c-355f32fac44b 43063-261 HUMAN PRESCRIPTION DRUG Pantoprazole SodiumDelayed-Release Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20080131 NDA NDA020987 PD-Rx Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 43063-262_29a49f8c-8993-41b4-a62a-09e1cf945069 43063-262 HUMAN PRESCRIPTION DRUG Pristiq Extended-Release Extended-Release desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20080501 NDA NDA021992 PD-Rx Pharmaceuticals, Inc. DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 43063-264_12cbf03e-cbf0-4c93-8771-b27fc4feb888 43063-264 HUMAN PRESCRIPTION DRUG tamsulosin hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078801 PD-Rx Pharmaceuticals, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 43063-265_6173f429-18d6-4698-9754-e8c03a17547f 43063-265 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20000912 ANDA ANDA040148 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 43063-266_776497bc-b336-4610-9788-15ba5f9ed15e 43063-266 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19820826 ANDA ANDA087916 PD-Rx Pharmaceuticals, Inc. DEXAMETHASONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43063-267_429ab75b-b606-4ea2-8dff-e8a5893eb097 43063-267 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20100228 ANDA ANDA089059 PD-Rx Pharmaceuticals, Inc. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 43063-268_86dc8b4e-2085-4124-9b3b-7c060e47e3c3 43063-268 HUMAN PRESCRIPTION DRUG Comfort Pac with Meloxicam Meloxicam KIT 20130709 ANDA ANDA077923 PD-Rx Pharmaceuticals, Inc. 43063-269_d8ef5724-08a8-4a4c-b906-9af8c777eb8b 43063-269 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 PD-Rx Pharmaceuticals, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 43063-270_86d2c448-bcf5-4cce-981f-ecb3c823b608 43063-270 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100127 ANDA ANDA076152 PD-Rx Pharmaceuticals, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-271_45772cd9-03d1-436d-a5ca-3cbdc3696765 43063-271 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20040214 ANDA ANDA075694 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43063-272_d11ac43c-ee87-4164-b1fa-1332e28c945b 43063-272 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074862 PD-Rx Pharmaceuticals, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-273_c7a75674-f591-4eb8-ab92-c793f9b289ea 43063-273 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 PD-Rx Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 43063-274_7fa68c02-7b4f-435b-863c-8fc46197b263 43063-274 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074862 PD-Rx Pharmaceuticals, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-275_7e9cd74c-a070-40b2-8f5d-8bc2c51a831b 43063-275 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074862 PD-Rx Pharmaceuticals, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-277_029ae3e3-2c1c-4afe-80c9-38af2c129fdb 43063-277 HUMAN PRESCRIPTION DRUG spironolactone spironolactone TABLET, FILM COATED ORAL 19600121 NDA AUTHORIZED GENERIC NDA012151 PD-Rx Pharmaceuticals, Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 43063-279_a3efb445-3b16-418b-b8fe-fd38278b4a0d 43063-279 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 19960730 ANDA ANDA040105 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-280_93862838-dff6-4643-8953-3109dfa65050 43063-280 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074769 PD-Rx Pharmaceuticals, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-284_2a60896d-304b-470b-9f98-652253df1bfe 43063-284 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100201 ANDA ANDA075491 PD-Rx Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 43063-288_7e5ea2d7-1822-47ab-9c58-f263868dd470 43063-288 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 PD-Rx Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 43063-290_119c4a5a-ab85-4713-b60e-0f67a573e044 43063-290 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20090817 ANDA ANDA040833 PD-Rx Pharmaceuticals, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 43063-292_7c791dac-7c21-44c5-bf39-32b3786da4d9 43063-292 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride TABLET ORAL 20091127 ANDA ANDA078301 PD-Rx Pharmaceuticals, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-295_4f9817b8-0456-4907-b0b1-677aa9d4cee8 43063-295 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA078445 PD-Rx Pharmaceuticals, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 43063-297_e7c74bb1-279c-47c8-9dc3-dde26d33431a 43063-297 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 ANDA ANDA074052 PD-Rx Pharmaceuticals, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43063-302_e011f478-dc4d-48cf-9dbd-e507630ec043 43063-302 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 PD-Rx Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 43063-303_7979bdef-b765-4b97-9739-f27f8cb98e6e 43063-303 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080609 ANDA ANDA077626 PD-Rx Pharmaceuticals, Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 43063-304_7e224411-cc17-4347-b640-35fe52cec387 43063-304 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20090302 ANDA ANDA077712 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-307_69a90361-a9e9-4ad8-829a-c0003f21d7d4 43063-307 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 PD-Rx Pharmaceuticals, Inc. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 43063-308_b1dc6500-b355-4d03-9d06-1664f9ef91fd 43063-308 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 PD-Rx Pharmaceuticals, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-313_0a1a038c-f645-4fa2-8b18-c3ae5dc1a688 43063-313 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 PD-Rx Pharmaceuticals, Inc. ISOSORBIDE MONONITRATE 60 mg/1 43063-316_e7515c6c-7902-41b4-9078-3a2c0f7b5a5f 43063-316 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073026 PD-Rx Pharmaceuticals, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43063-321_f0351cf8-8f21-40d6-8ee6-5a2ab7277204 43063-321 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL; SUBLINGUAL 20090921 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. HYOSCYAMINE SULFATE .125 mg/1 43063-323_3508ce60-811d-43cb-ad2a-b7ced44f7116 43063-323 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 43063-324_f58a07df-daa9-47e3-8b2d-c00a25864a68 43063-324 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 43063-326_7d718380-c91d-410d-99be-843c0d2c3e57 43063-326 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 PD-Rx Pharmaceuticals, Inc. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 43063-327_5c0db6d0-3aa1-4977-9f82-9dc302ef70f1 43063-327 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040746 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 43063-328_9c40add5-adc5-4ef1-bc57-b219a4cdf6ba 43063-328 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 PD-Rx Pharmaceuticals, Inc. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 43063-329_dd491177-c103-46e3-ae01-b01819338631 43063-329 HUMAN PRESCRIPTION DRUG methylergonovine maleate methylergonovine maleate TABLET ORAL 20110801 ANDA ANDA091577 PD-Rx Pharmaceuticals, Inc. METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 43063-332_2b5e3d72-0d02-420b-a121-91d9e6247440 43063-332 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040527 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 43063-336_8e1412ea-ea67-45fb-8d34-0b445bca9205 43063-336 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 PD-Rx Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 43063-339_07d92fa5-f42b-4504-a835-95e27a666983 43063-339 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19970214 ANDA ANDA040148 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 43063-340_f1cf7740-89bd-48ad-bb7e-8725d9670309 43063-340 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20091022 ANDA ANDA075382 PD-Rx Pharmaceuticals, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 43063-341_191a1bdd-d685-4251-85ce-dcec9787c7c2 43063-341 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, CHEWABLE ORAL 20111118 ANDA ANDA064013 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43063-342_824addbb-7add-4c05-ad56-e843d24f70a5 43063-342 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, CHEWABLE ORAL 20020418 ANDA ANDA065065 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 43063-343_e9eed721-5955-44b3-88cb-364e827756ef 43063-343 HUMAN PRESCRIPTION DRUG Mephyton phytonadione TABLET ORAL 19550930 NDA NDA010104 PD-Rx Pharmaceuticals, Inc. PHYTONADIONE 5 mg/1 Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 43063-344_8fdca7be-c9f5-4853-b2ab-0e438f2dbda4 43063-344 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 PD-Rx Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-345_40932790-05b8-49f4-9bab-55c3539a794f 43063-345 HUMAN PRESCRIPTION DRUG ARMOUR THYROID THYROID TABLET ORAL 20101019 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. THYROID, UNSPECIFIED 30 mg/1 43063-346_92ad4519-a723-48c6-8cdc-3af6426b5b90 43063-346 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20111227 ANDA ANDA079081 PD-Rx Pharmaceuticals, Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 43063-347_6a7dddbe-52f9-48a2-abe5-60c6e4a27f33 43063-347 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 PD-Rx Pharmaceuticals, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 43063-348_73e4fec1-a0fa-4ff8-a415-bd118a3c5786 43063-348 HUMAN PRESCRIPTION DRUG DIETHYLPROPION HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE TABLET ORAL 20101227 ANDA ANDA201212 PD-Rx Pharmaceuticals, Inc. DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 43063-349_8c298b41-db7b-4a09-aa20-8bdaae6042cf 43063-349 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED ORAL 20040401 ANDA ANDA076604 PD-Rx Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 43063-350_f4378d9f-a42b-4921-b0ef-698f6e12d90c 43063-350 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium clorazepate dipotassium TABLET ORAL 20100729 ANDA ANDA071858 PD-Rx Pharmaceuticals, Inc. CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43063-352_f0d96805-3e98-4423-a4ba-beb7530eb797 43063-352 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 PD-Rx Pharmaceuticals, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-353_d619f463-0ee9-4f1f-bdec-8faefcab4375 43063-353 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20101213 ANDA ANDA040185 PD-Rx Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 43063-354_88d16ab1-7fbd-4918-a9aa-fdca78f279ba 43063-354 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-358_35fb786e-bee9-4d93-b491-3460acfe9363 43063-358 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA AUTHORIZED GENERIC NDA019885 PD-Rx Pharmaceuticals, Inc. QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 43063-362_60e5a9bb-2f49-407c-8dc5-0c7391921d89 43063-362 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 PD-Rx Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 43063-364_e871e211-235e-4e04-9c05-49e758996078 43063-364 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43063-365_cb158bc3-0379-4a06-b7cd-bcc2cb40779b 43063-365 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970829 ANDA ANDA074979 PD-Rx Pharmaceuticals, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43063-366_cc38ce70-c3f6-4f55-b4c6-a710ebd6464f 43063-366 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 PD-Rx Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 43063-367_1fc534df-1121-47f5-8804-070374b2a7c4 43063-367 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43063-368_e0a83ffd-7abc-4c0e-9413-dbd28818e4c0 43063-368 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 PD-Rx Pharmaceuticals, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-370_2467096d-b637-42eb-acc9-97f6895242ae 43063-370 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43063-371_d11e4ab4-17f0-43e2-8a5a-5909912c3a9c 43063-371 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET ORAL 20120517 ANDA ANDA090844 PD-Rx Pharmaceuticals, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 43063-372_55d9cdf4-cf18-40e5-bcc2-b0716aeb8e22 43063-372 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20050412 ANDA ANDA076869 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43063-373_0b88c1aa-adf8-4e8c-97f9-0cc028f6a746 43063-373 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 PD-Rx Pharmaceuticals, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43063-374_b7bb9d92-c02b-430e-887d-645728107ead 43063-374 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 PD-Rx Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-377_d512cb96-9ba8-42a7-a511-907168176044 43063-377 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 43063-378_e442b25f-018c-47f9-8ba2-170e32c74141 43063-378 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 250 mg/1 43063-379_9b7aedd3-28d7-4fe3-83c3-68072dceb4b1 43063-379 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20030905 ANDA ANDA040535 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-380_99ff62b5-9dfd-4f8f-96d1-66bd0514089d 43063-380 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET ORAL 20120803 ANDA ANDA090655 PD-Rx Pharmaceuticals, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 43063-381_40666967-141c-42e0-8b04-45d75d0db82f 43063-381 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA090984 PD-Rx Pharmaceuticals, Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 43063-382_9c0b24d8-728c-4fbe-8aa1-26abdc4eae21 43063-382 HUMAN PRESCRIPTION DRUG Clorazepate dipotassium Clorazepate dipotassium TABLET ORAL 20050114 ANDA ANDA076911 PD-Rx Pharmaceuticals, Inc. CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43063-383_4bd1c013-75b6-4b68-a356-65d5bbc141e5 43063-383 HUMAN PRESCRIPTION DRUG ANASTROZOLE ANASTROZOLE TABLET ORAL 20100628 ANDA ANDA079220 PD-Rx Pharmaceuticals, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 43063-384_7b7ca5f4-a538-4594-ad9f-5f3e646bb16d 43063-384 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 43063-385_a094c625-cd14-477d-9218-a8972f170f32 43063-385 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100913 ANDA ANDA077289 PD-Rx Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-386_3a77aac7-a1cb-4ce8-83e4-c97a1397ac2f 43063-386 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 19730618 ANDA ANDA083365 PD-Rx Pharmaceuticals, Inc. HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43063-387_f5018d8a-702c-45d8-bd88-32ce17878a14 43063-387 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081125 ANDA ANDA077284 PD-Rx Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 43063-388_4889f5a4-f52c-4c5f-8c83-d12063fe807c 43063-388 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070612 ANDA ANDA077284 PD-Rx Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 43063-389_484dcb87-e290-4888-ac73-067767e33973 43063-389 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 PD-Rx Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-390_1b6d4de2-60b8-4291-ac1c-fc27492b8fdb 43063-390 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 PD-Rx Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-391_fda6b3c4-6af8-4922-9647-3d964f81b6d1 43063-391 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20100315 ANDA ANDA040865 PD-Rx Pharmaceuticals, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 43063-392_6747a578-3e79-445c-be09-07244ce9fb33 43063-392 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 PD-Rx Pharmaceuticals, Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 43063-393_38f80193-38a7-4c01-b583-8f3e4780a5cb 43063-393 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20110818 ANDA ANDA091211 PD-Rx Pharmaceuticals, Inc. ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 43063-394_4972c2ef-8256-444b-b4dd-9b7171ab2941 43063-394 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20050812 ANDA ANDA065242 PD-Rx Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 43063-396_746c553b-00f9-4254-996f-45942e2c7dbb 43063-396 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100630 ANDA ANDA077918 PD-Rx Pharmaceuticals, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-400_2b4b4faf-d9b5-4b18-a85f-2076b05fcbb5 43063-400 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 PD-Rx Pharmaceuticals, Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 43063-401_87be3ea0-6064-47f5-928a-edf1d8c264c7 43063-401 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 PD-Rx Pharmaceuticals, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-402_d3d51fbc-ec14-4973-b6ef-348b89d4e143 43063-402 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20070521 ANDA ANDA077179 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 43063-403_b1f7b014-38ed-4ca8-a7da-ea31843184bd 43063-403 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 PD-Rx Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 43063-404_30c38d0b-6e33-4f40-ac4f-81bf5da50356 43063-404 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100621 ANDA ANDA078477 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 43063-405_d0fab583-8605-49e8-8267-b4cf56f5dff8 43063-405 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 PD-Rx Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 43063-406_d37cfc17-402b-4338-86c9-482514bc97fc 43063-406 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA087479 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 43063-407_38bad3b2-5316-44fb-8074-1d3db8bb4e76 43063-407 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 PD-Rx Pharmaceuticals, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 43063-408_23f27db6-8d6e-4031-b803-1ad5244fb5f9 43063-408 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980520 ANDA ANDA075009 PD-Rx Pharmaceuticals, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-409_130afe89-522f-4739-b86e-139437a31bad 43063-409 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 PD-Rx Pharmaceuticals, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 43063-410_4dbbe857-93e6-4be6-93eb-815dddc050e6 43063-410 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 PD-Rx Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 43063-411_d9a843b6-5181-407e-813f-bece7f48fa69 43063-411 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA AUTHORIZED GENERIC NDA019839 PD-Rx Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-412_ca85659b-fbf8-498e-b22a-82f731c84832 43063-412 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20120127 ANDA ANDA091662 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43063-413_d56293d8-53a3-461c-b585-1eb042c78e52 43063-413 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090810 ANDA ANDA077864 PD-Rx Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-414_0de33fdd-f90a-4aa5-8312-ad9552a6edcc 43063-414 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 43063-415_c3cad3c1-94f9-4e4c-afac-a6ffe2c3ccbf 43063-415 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19720522 ANDA ANDA080292 PD-Rx Pharmaceuticals, Inc. PREDNISONE 5 mg/1 43063-416_01821c4b-1cb0-4230-acdc-e7ac23c80a66 43063-416 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 PD-Rx Pharmaceuticals, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 43063-417_a98de110-f3a3-4018-9af2-af0cf7a9bba2 43063-417 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43063-418_b0ce68d2-a1b1-42d8-893f-6aa8c1191df3 43063-418 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 PD-Rx Pharmaceuticals, Inc. MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 43063-419_6e3aa15b-88ac-4b64-9ffe-6c90d60cfd38 43063-419 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 PD-Rx Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 43063-420_5045d52d-c8be-474e-846c-7da3ebd9f8f4 43063-420 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 43063-421_352902c0-8c79-49bb-bfd4-1e83a5cd0405 43063-421 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 43063-422_f3dab20d-5bd2-4c91-8095-4505e1a9f306 43063-422 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 43063-423_a48b1976-dbb3-4ed2-9588-90f4b5730bc4 43063-423 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 43063-424_aafa9e90-bdf4-474c-966f-4f1e04fcff16 43063-424 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20110209 NDA NDA019129 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43063-425_2f3f78ca-5e65-4c54-af03-c7befa7f6e10 43063-425 HUMAN PRESCRIPTION DRUG benzphetamine hydrochloride benzphetamine hydrochloride TABLET ORAL 20111101 ANDA ANDA090473 PD-Rx Pharmaceuticals, Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 43063-426_2c4dbefc-f8ab-4bc3-a266-ee7704c1d38d 43063-426 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 PD-Rx Pharmaceuticals, Inc. PREDNISONE 10 mg/1 43063-427_7792dfc4-8e1f-4167-95a4-d503f2765936 43063-427 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 PD-Rx Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 43063-428_35991408-3b5a-46c3-a29b-0e2184e89a56 43063-428 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091202 ANDA ANDA078596 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43063-429_7a03f9e4-dcad-40bf-b6bf-ba215fe19bbc 43063-429 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin TABLET ORAL 20090601 ANDA ANDA077880 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43063-430_437669a4-8e61-4aaa-ae96-a66a0ad238ae 43063-430 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20120427 ANDA ANDA077880 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43063-431_f4918c15-5eb0-474d-a54e-979f09523eb1 43063-431 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 20121012 ANDA ANDA072741 PD-Rx Pharmaceuticals, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 43063-432_69d47d73-be84-4ebd-ba11-00c2e85b7400 43063-432 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19740226 ANDA ANDA083677 PD-Rx Pharmaceuticals, Inc. PREDNISONE 20 mg/1 43063-433_0430a5a2-66d0-4b68-a95f-d9125c99d5a3 43063-433 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19940401 NDA AUTHORIZED GENERIC NDA017532 PD-Rx Pharmaceuticals, Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 43063-434_3abb85b1-2a3f-4106-ae5f-50af72a74723 43063-434 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19900930 ANDA ANDA061926 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43063-435_ea5b10c8-42e8-4247-85b0-6e0402f90fce 43063-435 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20070629 ANDA ANDA040808 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 43063-436_43f6351f-ef9a-4412-9c04-0babef4e8f43 43063-436 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43063-437_6d96186e-72e6-449a-99d8-bd1b4ab9d202 43063-437 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20110308 ANDA ANDA200272 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 43063-438_8e56ef60-5ec1-4496-b898-6715d2317a47 43063-438 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE TABLET ORAL 19590603 NDA AUTHORIZED GENERIC NDA011839 PD-Rx Pharmaceuticals, Inc. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 43063-439_413fe196-b797-45d1-911e-7a7ef68be76f 43063-439 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate TABLET ORAL 19901101 ANDA ANDA081099 PD-Rx Pharmaceuticals, Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 43063-440_38749ece-6a87-4850-b1f0-4d9b26f41877 43063-440 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20110504 ANDA ANDA076704 PD-Rx Pharmaceuticals, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43063-441_c8c13008-5135-4a0d-afbd-b89ec4245d13 43063-441 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43063-442_bd79f163-2de5-4d81-bbe1-5686fbaac808 43063-442 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19880617 ANDA ANDA072011 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43063-443_4a711ac6-9bbe-4377-8d33-e0053884bd48 43063-443 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 PD-Rx Pharmaceuticals, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43063-444_35002005-3cef-4c95-8579-d94ffcdd9f8e 43063-444 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 PD-Rx Pharmaceuticals, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43063-445_d07c4568-f318-4d04-aa9d-f61c9051c1bc 43063-445 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 PD-Rx Pharmaceuticals, Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-446_7a0b4f3d-e929-4bb3-8778-5ca88d03b94a 43063-446 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 PD-Rx Pharmaceuticals, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 43063-447_6ddcecae-9c4e-40a2-bc7b-ff618b51c5ef 43063-447 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 PD-Rx Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 43063-451_99f4ccb9-6739-4753-bafd-4f4813ed8918 43063-451 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA076048 PD-Rx Pharmaceuticals, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 43063-452_48c6e485-783a-4c86-a970-84de744596ac 43063-452 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20120828 ANDA ANDA077923 PD-Rx Pharmaceuticals, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-453_0d6cb241-94ce-4c9f-9054-18ef76e41847 43063-453 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 PD-Rx Pharmaceuticals, Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43063-454_8411bc4c-37a0-41c0-87d5-38037d8475cf 43063-454 HUMAN PRESCRIPTION DRUG Chloroquine Phosphate Chloroquine Phosphate TABLET, FILM COATED ORAL 20110315 ANDA ANDA090249 PD-Rx Pharmaceuticals, Inc. CHLOROQUINE PHOSPHATE 500 mg/1 Antimalarial [EPC] 43063-455_df653dba-0bd0-48a9-9146-bb59246eae35 43063-455 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 PD-Rx Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 43063-457_9f68e553-51d2-4656-b064-bafe9f8743be 43063-457 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 43063-458_6a64ade0-d6ea-4d48-a7f1-067244623b9b 43063-458 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20061004 ANDA ANDA077912 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 43063-459_5cb2967a-d344-4b8f-9deb-a2a11cc68318 43063-459 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 43063-460_a0a0d59f-67f3-40f2-a9e8-072ba90f7eb0 43063-460 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20061206 ANDA ANDA077563 PD-Rx Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 43063-462_945c19b4-40d1-438e-863f-a06c767379ab 43063-462 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 19931222 ANDA ANDA074198 PD-Rx Pharmaceuticals, Inc. NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-463_37b04bf8-a166-43c2-93e5-ddc9efa1856c 43063-463 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080937 PD-Rx Pharmaceuticals, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] 43063-465_fcbcabff-5781-45cf-8565-2139960eaf7f 43063-465 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20050415 ANDA ANDA040555 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 43063-466_1143e640-4160-4527-845c-466d976392da 43063-466 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20070501 ANDA ANDA065264 PD-Rx Pharmaceuticals, Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 43063-467_84801841-267a-4ed4-a11e-2554acc53373 43063-467 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 PD-Rx Pharmaceuticals, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-468_8973ce17-53ce-48ac-bf1c-30c575a59aaa 43063-468 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060410 ANDA ANDA077912 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 43063-469_121b1289-f9a6-46f1-bbb4-5ce4a6bd89a6 43063-469 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 19980508 ANDA ANDA074918 PD-Rx Pharmaceuticals, Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] 43063-470_aeb25452-48a5-4013-9662-411e171f5853 43063-470 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090899 PD-Rx Pharmaceuticals, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-471_ad0727d0-9248-4266-8ca8-0ad20d14e96d 43063-471 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 ANDA ANDA040145 PD-Rx Pharmaceuticals, Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 43063-472_7ae0b489-829f-4382-b006-75cffd837b89 43063-472 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA085161 PD-Rx Pharmaceuticals, Inc. PREDNISONE 20 mg/1 43063-473_5b624e87-0cef-4f53-ad53-ab3dfb8c4293 43063-473 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19900930 ANDA ANDA062286 PD-Rx Pharmaceuticals, Inc. DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43063-474_facea669-0591-4431-b50f-95900ce3d136 43063-474 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 PD-Rx Pharmaceuticals, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43063-475_72316956-10f2-4a63-8c71-6878189cb64d 43063-475 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 43063-476_658c2163-720a-4bd1-956d-3aed88d66f6b 43063-476 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19920801 20150430 ANDA ANDA073568 PD-Rx Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 43063-477_09c46416-5905-4247-ae5a-09eea22e74c7 43063-477 HUMAN PRESCRIPTION DRUG losartan potassium losartan potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA077424 PD-Rx Pharmaceuticals, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 43063-478_04dd0c51-ce13-4daf-85e9-0b3f0b8d494a 43063-478 HUMAN PRESCRIPTION DRUG losartan potassium losartan potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA077424 PD-Rx Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 43063-479_150410d9-0f19-4a46-9aa0-036b072d17c7 43063-479 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET, FILM COATED ORAL 20110906 ANDA ANDA090199 PD-Rx Pharmaceuticals, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 43063-480_dc6b518b-cc5f-4863-ba69-f1ff6fa0bb53 43063-480 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 43063-481_be3b6ec9-6fde-47ff-9e93-bd53c6917697 43063-481 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 PD-Rx Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-482_63345f9b-83c1-4537-b71b-e854ed09f675 43063-482 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20061004 ANDA ANDA077912 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 43063-483_25a09f56-4873-443b-a0dd-1797f4e293c0 43063-483 HUMAN PRESCRIPTION DRUG losartan potassium losartan potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA077424 PD-Rx Pharmaceuticals, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 43063-484_eedff504-c491-4ca7-8970-b43a33862f8a 43063-484 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 43063-485_45fbacbf-e86e-44cc-850b-d8c2f4f2e09d 43063-485 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 43063-486_1ad80b08-fef4-4579-be42-353e74251e70 43063-486 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin TABLET, FILM COATED ORAL 20040128 ANDA ANDA076182 PD-Rx Pharmaceuticals, Inc. OFLOXACIN 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 43063-487_e78d3b5c-38a8-4673-a542-1a7d1e4a3981 43063-487 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 PD-Rx Pharmaceuticals, Inc. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43063-489_ceba7e9a-2ecb-45ed-a258-d956bed18148 43063-489 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19920801 20150430 ANDA ANDA074330 PD-Rx Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 43063-490_2bd4ca9a-00f3-4f89-b3e7-754031819c7f 43063-490 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43063-491_6456c1d6-d24c-40ae-8990-37084ebc758c 43063-491 HUMAN PRESCRIPTION DRUG Losartan potassium and hydrochlorothiazide Losartan potassium and hydrochlorothiazide tablets TABLET, FILM COATED ORAL 20101006 ANDA ANDA077948 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43063-492_443141d7-a3d9-4dd9-8a90-0ecae298cc94 43063-492 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE ORAL 20091216 ANDA ANDA040765 PD-Rx Pharmaceuticals, Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43063-493_cfe06913-9295-44a3-9e52-a40f7478dbc9 43063-493 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 PD-Rx Pharmaceuticals, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43063-494_0fd8d94c-2b5f-4386-a50d-f70ddfcae92e 43063-494 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20120314 ANDA ANDA078048 PD-Rx Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 43063-495_cf3fde41-3c62-479b-bb25-a79a865085ba 43063-495 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous terazosin hydrochloride anhydrous CAPSULE ORAL 20130222 ANDA ANDA075140 PD-Rx Pharmaceuticals, Inc. TERAZOSIN HYDROCHLORIDE ANHYDROUS 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 43063-496_5864f7be-36e0-4421-b236-6bc1fa788459 43063-496 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 PD-Rx Pharmaceuticals, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 43063-497_ea78a6e0-fe9d-4358-8196-6c18c2924187 43063-497 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110120 ANDA ANDA090836 PD-Rx Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 43063-498_3ad541b2-3d5a-4930-a510-d5747bf739cb 43063-498 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET, FILM COATED ORAL 20110425 ANDA ANDA090370 PD-Rx Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 43063-499_718c5451-11ca-4e69-8b05-965b739c55b8 43063-499 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078858 PD-Rx Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43063-500_0339a051-489c-4614-8f83-4f71d87a0664 43063-500 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110601 ANDA ANDA090493 PD-Rx Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 43063-501_970fac91-cb42-4091-958f-4d7262201933 43063-501 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087128 PD-Rx Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 43063-502_c493a28d-13cb-42ca-9c9d-c403d0ef2f63 43063-502 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080610 ANDA ANDA077626 PD-Rx Pharmaceuticals, Inc. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 43063-503_e0a80d3c-635d-4ef3-94f0-1da6bf195ce7 43063-503 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride4b17de Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 PD-Rx Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 43063-505_08fede37-ec6a-4483-ac30-06f62afaac64 43063-505 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080606 ANDA ANDA078829 PD-Rx Pharmaceuticals, Inc. ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 43063-506_a5b15778-95fb-4477-a2d6-6ed511615008 43063-506 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20110718 ANDA ANDA065509 PD-Rx Pharmaceuticals, Inc. AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 43063-507_b872478b-fe55-4df6-a8ea-ccd5193c10b6 43063-507 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43063-508_cfff2eb0-98b4-4fd2-a7cc-1d642865db5a 43063-508 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 PD-Rx Pharmaceuticals, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 43063-509_f43289da-b4b0-430d-8f09-19bece680535 43063-509 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 PD-Rx Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 43063-510_3af89a9a-b32e-4163-b29d-e46053118b38 43063-510 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 PD-Rx Pharmaceuticals, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 43063-511_1ee8a41f-6f1b-4ba8-bcf6-aa1fdcb4207e 43063-511 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20131018 ANDA ANDA091393 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-512_abf954d7-5bcf-4dac-ae93-525b1a5df8a2 43063-512 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20131018 ANDA ANDA091393 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-516_d8d1fa35-2f60-4d60-8e46-be864c89ade6 43063-516 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20120314 ANDA ANDA078048 PD-Rx Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 43063-517_0840e982-3f63-4e2d-be9f-d62b8c0c0369 43063-517 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040786 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 43063-518_0ce52991-d678-43a2-b5e2-776404c6ed90 43063-518 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040787 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 43063-519_716d885b-9b86-44ef-94a4-2771f1c4c4dc 43063-519 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040788 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 43063-520_eadb4f37-b08a-45be-b3f0-778682cb6f5a 43063-520 HUMAN PRESCRIPTION DRUG clarithromycin clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080101 ANDA ANDA065145 PD-Rx Pharmaceuticals, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 43063-521_4b12b19d-efbe-427e-8fde-2b9ec2a5fcf2 43063-521 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 PD-Rx Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43063-522_47b3a86f-913b-4aa3-8889-cd4fcdeca4b9 43063-522 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil HCl atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20120727 NDA AUTHORIZED GENERIC NDA021078 PD-Rx Pharmaceuticals, Inc. ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 43063-523_537c3093-abd7-4499-91af-3cb47869e7ca 43063-523 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20130412 ANDA ANDA201447 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-524_2375b4a0-6b12-4269-a543-6c5a67bd3f41 43063-524 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065211 PD-Rx Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 43063-525_11a2e3a9-8e60-4895-9ca8-504fc4a1a9ab 43063-525 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 43063-526_99db5785-cbe9-4fba-a5a0-18e53cf4a72f 43063-526 HUMAN PRESCRIPTION DRUG Comfort Pac with Meloxicam Meloxicam KIT 20100630 ANDA ANDA077918 PD-Rx Pharmaceuticals, Inc. 43063-527_9f283ec6-9b75-4ae1-9cfd-b54a9b0398ef 43063-527 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43063-528_85f5ad84-b457-47e9-b31c-ccefb2643c10 43063-528 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131127 ANDA ANDA201447 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-529_0a3adeb3-0cbf-4200-840a-d0376659c5b2 43063-529 HUMAN PRESCRIPTION DRUG Doxycycline Monohydrate Doxycycline CAPSULE ORAL 20050207 NDA AUTHORIZED GENERIC NDA050641 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE 100 mg/1 43063-530_baca5415-e2dc-486c-9cbc-164d5753f721 43063-530 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20050825 ANDA ANDA065136 PD-Rx Pharmaceuticals, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 43063-531_42136acd-856d-4053-bb00-e4c0f873ab27 43063-531 HUMAN PRESCRIPTION DRUG Xartemis XR oxycodone hydrochloride and acetaminophen TABLET, COATED ORAL 20130430 NDA NDA204031 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 43063-532_7a648f77-592d-4a74-84e6-52f8f068cf97 43063-532 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride ER Diethylpropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111024 ANDA ANDA091680 PD-Rx Pharmaceuticals, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 43063-533_349e439a-44f2-4142-8501-255cd63267e5 43063-533 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075511 PD-Rx Pharmaceuticals, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 43063-534_acd227e0-6dca-40ef-a5a1-ffec1bf2ef5d 43063-534 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET, FILM COATED ORAL 20110425 ANDA ANDA090370 PD-Rx Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 43063-536_e48a654a-0c6c-43b4-b6e9-2d653f272517 43063-536 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110120 ANDA ANDA090836 PD-Rx Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 43063-537_fc58c8ae-513f-42b1-9e45-bb77c3033d8a 43063-537 HUMAN PRESCRIPTION DRUG SUPRAX cefixime CAPSULE ORAL 20130315 NDA NDA203195 PD-Rx Pharmaceuticals, Inc. CEFIXIME 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 43063-538_5c6a5821-0fb3-4e51-81a7-439a614bf19e 43063-538 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43063-539_e6f3ed3d-a643-44d0-9f14-fa098f807701 43063-539 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140201 ANDA ANDA203769 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43063-540_c601d37d-3857-4056-a1d9-4ab458995974 43063-540 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065212 PD-Rx Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 43063-541_bb253f38-00a3-404e-8855-71ab4cc59ce5 43063-541 HUMAN PRESCRIPTION DRUG BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET ORAL 20100721 ANDA ANDA090968 PD-Rx Pharmaceuticals, Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 43063-542_c6b5648a-bf19-49e4-9da2-0d04e9127b35 43063-542 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120112 ANDA ANDA062058 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43063-543_070da840-cfb5-40b4-8591-b9053e1f3b72 43063-543 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960308 NDA AUTHORIZED GENERIC NDA020254 PD-Rx Pharmaceuticals, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43063-544_5ea39beb-1945-4814-a7d0-fa525ecaf414 43063-544 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43063-545_f763229e-a4ac-4372-ae84-08490a49c405 43063-545 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140201 ANDA ANDA203769 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43063-546_c4b26ce0-2d4a-4750-96bd-7f37879f94e1 43063-546 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140201 ANDA ANDA203769 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43063-547_289a0b3b-431d-422c-a8b4-9b245fe59dd5 43063-547 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20091010 ANDA ANDA076126 PD-Rx Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 43063-548_cc72667b-bc90-4d9a-83d3-25b912656bee 43063-548 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 PD-Rx Pharmaceuticals, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43063-549_bf8e694d-d83d-417f-82d0-f3f1f51ad73d 43063-549 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 PD-Rx Pharmaceuticals, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 43063-550_ee662eb6-0495-452a-9947-03f859f15cf0 43063-550 HUMAN PRESCRIPTION DRUG Sildenafil sildenafil citrate TABLET, FILM COATED ORAL 20120927 NDA AUTHORIZED GENERIC NDA021845 PD-Rx Pharmaceuticals, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 43063-551_1cb415c3-6f16-471d-994d-7bf45a91b292 43063-551 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19860610 ANDA ANDA070278 PD-Rx Pharmaceuticals, Inc. HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] 43063-553_ae57a7ee-871e-4e62-8792-6e45cc5d2cdd 43063-553 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20080423 ANDA ANDA065392 PD-Rx Pharmaceuticals, Inc. CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 43063-554_75b8a35e-4472-48d5-a43c-b996a5a83b97 43063-554 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20080529 ANDA ANDA040779 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 43066-150_3f4b9735-732b-4f4a-a1e5-57df44311b30 43066-150 HUMAN PRESCRIPTION DRUG Nexterone amiodarone hydrochloride INJECTION, SOLUTION INTRAVENOUS 20101116 NDA NDA022325 Baxter Healthcare Corporation AMIODARONE HYDROCHLORIDE 1.5 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 43066-360_3f4b9735-732b-4f4a-a1e5-57df44311b30 43066-360 HUMAN PRESCRIPTION DRUG Nexterone amiodarone hydrochloride INJECTION, SOLUTION INTRAVENOUS 20101116 NDA NDA022325 Baxter Healthcare Corporation AMIODARONE HYDROCHLORIDE 1.8 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 43068-101_47352d8b-5b97-4090-b88a-6d960f4cc419 43068-101 HUMAN PRESCRIPTION DRUG Fanapt iloperidone TABLET ORAL 20091001 NDA NDA022192 Vanda Pharmaceuticals Inc. ILOPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 43068-102_47352d8b-5b97-4090-b88a-6d960f4cc419 43068-102 HUMAN PRESCRIPTION DRUG Fanapt iloperidone TABLET ORAL 20091001 NDA NDA022192 Vanda Pharmaceuticals Inc. ILOPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 43068-104_47352d8b-5b97-4090-b88a-6d960f4cc419 43068-104 HUMAN PRESCRIPTION DRUG Fanapt iloperidone TABLET ORAL 20091001 NDA NDA022192 Vanda Pharmaceuticals Inc. ILOPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 43068-106_47352d8b-5b97-4090-b88a-6d960f4cc419 43068-106 HUMAN PRESCRIPTION DRUG Fanapt iloperidone TABLET ORAL 20091001 NDA NDA022192 Vanda Pharmaceuticals Inc. ILOPERIDONE 6 mg/1 Atypical Antipsychotic [EPC] 43068-108_47352d8b-5b97-4090-b88a-6d960f4cc419 43068-108 HUMAN PRESCRIPTION DRUG Fanapt iloperidone TABLET ORAL 20091001 NDA NDA022192 Vanda Pharmaceuticals Inc. ILOPERIDONE 8 mg/1 Atypical Antipsychotic [EPC] 43068-110_47352d8b-5b97-4090-b88a-6d960f4cc419 43068-110 HUMAN PRESCRIPTION DRUG Fanapt iloperidone TABLET ORAL 20091001 NDA NDA022192 Vanda Pharmaceuticals Inc. ILOPERIDONE 10 mg/1 Atypical Antipsychotic [EPC] 43068-112_47352d8b-5b97-4090-b88a-6d960f4cc419 43068-112 HUMAN PRESCRIPTION DRUG Fanapt iloperidone TABLET ORAL 20091001 NDA NDA022192 Vanda Pharmaceuticals Inc. ILOPERIDONE 12 mg/1 Atypical Antipsychotic [EPC] 43068-113_47352d8b-5b97-4090-b88a-6d960f4cc419 43068-113 HUMAN PRESCRIPTION DRUG Fanapt iloperidone KIT ORAL 20091001 NDA NDA022192 Vanda Pharmaceuticals Inc. 43068-220_9dfa71b8-de12-491a-82cd-7ebb8a6f2823 43068-220 HUMAN PRESCRIPTION DRUG Hetlioz tasimelteon CAPSULE ORAL 20140404 NDA NDA205677 Vanda Pharmaceuticals Inc. TASIMELTEON 20 mg/1 Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA] 43071-100_3ee68abc-03ef-4b93-8e12-554368bdde3e 43071-100 HUMAN OTC DRUG MIRAE SKIN WITCH HAZEL SOAP TOPICAL 20110701 OTC MONOGRAPH FINAL part347 HUMAN AND NATURE CO., LTD. WITCH HAZEL .15 g/150g 43071-110_cdf59ddd-5529-4a05-acc4-95c9ccda40a2 43071-110 HUMAN OTC DRUG MIRAE HAIR WITCH HAZEL SOAP TOPICAL 20110701 OTC MONOGRAPH FINAL part347 HUMAN AND NATURE CO., LTD. WITCH HAZEL .225 g/150g 43074-101_02e313a5-26b8-429f-a694-1ec91333eb89 43074-101 HUMAN OTC DRUG StaphWash Plus zinc acetate LIQUID TOPICAL 20100823 OTC MONOGRAPH FINAL part347 Phillips Company ZINC ACETATE .001 mg/mL 43074-102_080bfc73-aee9-4752-97c0-8296a93f8c30 43074-102 HUMAN OTC DRUG Acneen SALICYLIC ACID LOTION TOPICAL 20101230 OTC MONOGRAPH FINAL part333D Phillips Company SALICYLIC ACID .02 mL/mL 43074-103_255ddf24-7e33-471d-ab91-bc98652e760a 43074-103 HUMAN OTC DRUG TETRA-ABC TETRACYCLINE HYDROCHLORIDE OINTMENT TOPICAL 20100824 OTC MONOGRAPH FINAL part333B Phillips Company TETRACYCLINE HYDROCHLORIDE .03 mg/mL 43074-105_3b27d0ae-6e49-4b49-b67e-26a38fd9c76f 43074-105 HUMAN OTC DRUG StaphWash Plus zinc acetate LIQUID TOPICAL 20100823 OTC MONOGRAPH FINAL part347 Phillips Company ZINC ACETATE .001 mg/mL 43074-108_683dc33c-ba75-4a12-acb1-e82d0ea98d78 43074-108 HUMAN OTC DRUG Dyabetex TETRACYCLINE HYDROCHLORIDE OINTMENT TOPICAL 20100824 OTC MONOGRAPH FINAL part333B Phillips Company TETRACYCLINE HYDROCHLORIDE .03 mg/mL 43074-110_607f1e90-14fe-4774-8b3d-e2276e92604c 43074-110 HUMAN OTC DRUG Acneclir SALICYLIC ACID LOTION TOPICAL 20101230 OTC MONOGRAPH FINAL part333D Phillips Company SALICYLIC ACID .02 mL/mL 43074-111_50d6fcb2-68f1-4fa4-8f50-93b80a53e2e9 43074-111 HUMAN OTC DRUG Dermoneen SALICYLIC ACID LOTION TOPICAL 20110106 OTC MONOGRAPH FINAL part333D Phillips Company SALICYLIC ACID .02 mL/mL 43074-112_f934f64d-4fc0-4344-85fa-51312257a591 43074-112 HUMAN OTC DRUG Diabecline TETRACYCLINE HYDROCHLORIDE OINTMENT TOPICAL 20130610 OTC MONOGRAPH FINAL part333B Phillips Company TETRACYCLINE HYDROCHLORIDE 30 mg/g 43074-113_44ab0779-170a-4870-9198-12efcbfdfdd8 43074-113 HUMAN OTC DRUG Ecoderm Colloidal Oatmeal LOTION TOPICAL 20101230 OTC MONOGRAPH FINAL part347 Phillips Company OATMEAL .001 mL/mL 43074-114_94aab24d-fca0-490a-9eac-822490ac8a54 43074-114 HUMAN OTC DRUG Advanced Jellyfish Sting Kit zinc acetate POWDER, FOR SUSPENSION TOPICAL 20101112 OTC MONOGRAPH FINAL part347 Phillips Company ZINC ACETATE .001 mg/mL 43074-115_280ce59e-9a59-4320-a51a-35fd4e1724e7 43074-115 HUMAN OTC DRUG Tetracycline-ABC TETRACYCLINE HYDROCHLORIDE OINTMENT TOPICAL 20110215 OTC MONOGRAPH FINAL part333B Phillips Company TETRACYCLINE HYDROCHLORIDE .03 mg/mL 43074-116_71e97088-421a-4286-a5de-3cd1561d8350 43074-116 HUMAN OTC DRUG Acnecycline TETRACYCLINE HYDROCHLORIDE OINTMENT TOPICAL 20110215 OTC MONOGRAPH FINAL part333B Phillips Company TETRACYCLINE HYDROCHLORIDE .03 mg/mL 43074-205_b7dccefd-6cf5-4dda-afa8-8cbeb7f9de64 43074-205 HUMAN OTC DRUG StingMed zinc acetate LIQUID TOPICAL 20100823 OTC MONOGRAPH FINAL part347 Phillips Company ZINC ACETATE .001 mg/mL 43074-207_403d2eaa-af1c-4480-9408-b038bfd3625e 43074-207 HUMAN OTC DRUG VenomX zinc acetate LIQUID TOPICAL 20100823 OTC MONOGRAPH FINAL part347 Phillips Company ZINC ACETATE .001 mg/mL 43074-208_72a4fe26-76fb-4381-8bf3-b7c11cbe2229 43074-208 HUMAN OTC DRUG IvyMed zinc acetate LIQUID TOPICAL 20100823 OTC MONOGRAPH FINAL part347 Phillips Company ZINC ACETATE .001 mg/mL 43074-301_e739bfd8-0b05-48b3-859e-e6400d67b721 43074-301 HUMAN OTC DRUG TetraStem TETRACYCLINE HYDROCHLORIDE OINTMENT TOPICAL 20140225 OTC MONOGRAPH FINAL part333B Phillips Company TETRACYCLINE HYDROCHLORIDE 30 mg/g 43078-001_0b20db42-06c0-4f97-a05d-7f4b649fef29 43078-001 HUMAN OTC DRUG ARTHRI-SUPPORT menthol CREAM TOPICAL 20071201 OTC MONOGRAPH NOT FINAL part348 Pure Science International, Inc. MENTHOL 5 g/100g 43087-575_9ae4c5e2-0d0a-4bf3-9896-99c7c5fa59c4 43087-575 HUMAN OTC DRUG Puri-San Plus BENZETHONIUM CHLORIDE LIQUID TOPICAL 20090201 OTC MONOGRAPH NOT FINAL part333 People's Janitorial Supply BENZETHONIUM CHLORIDE 2 mg/mL 43093-100_1262af65-982c-461a-92d6-d00841a1fb99 43093-100 HUMAN PRESCRIPTION DRUG Synapryn Tramadol Hydrochloride KIT ORAL 20090914 UNAPPROVED DRUG OTHER Fusion Pharmaceuticals LLC 43093-101_b3e7707b-1491-409a-a336-4db2a026cdae 43093-101 HUMAN PRESCRIPTION DRUG Tabradol Cyclobenzaprine Hydrochloride KIT ORAL 20090917 UNAPPROVED DRUG OTHER Fusion Pharmaceuticals LLC 43093-104_238f9942-789c-49f7-b941-37ad8aa31a49 43093-104 HUMAN PRESCRIPTION DRUG Dicopanol Diphenhydramine Hydrochloride KIT ORAL 20100208 UNAPPROVED DRUG OTHER Fusion Pharmaceuticals LLC 43093-105_4f894361-aa8e-4384-b4eb-91416d060bc7 43093-105 HUMAN PRESCRIPTION DRUG Fanatrex Gabapentin KIT ORAL 20100515 UNAPPROVED DRUG OTHER Fusion Pharmaceuticals LLC 43097-575_8ecdad4c-c449-4617-b878-463ec33a9d61 43097-575 HUMAN OTC DRUG Puri-San Plus BENZETHONIUM CHLORIDE LIQUID TOPICAL 20090201 OTC MONOGRAPH NOT FINAL part333 People's Janitorial Supply BENZETHONIUM CHLORIDE 2 mg/mL 43105-1000_d40221fc-75d4-4487-b153-5594e428d908 43105-1000 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19690101 UNAPPROVED MEDICAL GAS Liberty Health Supplies, LLC OXYGEN 99 L/100L 43115-123_7a760252-889a-4a89-921a-cc277ec2a3ae 43115-123 HUMAN OTC DRUG NIA 24 SPF 30 HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20110609 OTC MONOGRAPH FINAL part352 Niadyne Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 7.5; 5; 2.6 mL/100mL; mL/100mL; mL/100mL; mL/100mL 43128-001_0cd60900-6be0-4271-95a5-dc7e4fe6f509 43128-001 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A NDC, Inc. HYDROGEN PEROXIDE 30 mg/mL 43128-002_b8721c65-a893-45fb-9d7e-51a9174b9640 43128-002 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A NDC, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 43128-035_180436b2-66ce-42e7-a298-280616304331 43128-035 HUMAN OTC DRUG Pro Advantage Fast Absorbing Perineal with Dimethicone Skin Protectant DIMETHICONE CREAM TOPICAL 20130307 OTC MONOGRAPH FINAL part347 NDC National Distribution & Contracting, Inc. DIMETHICONE 20 mg/mL 43128-050_d3027aec-91b0-49c5-aaad-d1370ee05262 43128-050 HUMAN OTC DRUG Alcohol Prep pad Isopropyl Alcohol SWAB TOPICAL 20111215 OTC MONOGRAPH FINAL part333A NDC National Distribution & Contracting, Inc. ISOPROPYL ALCOHOL .7 mL/mL 43128-108_c669a212-3efd-424e-8538-8106b613ae25 43128-108 HUMAN OTC DRUG Pro Advantage Antibacterial TRICLOSAN LIQUID TOPICAL 20130308 OTC MONOGRAPH NOT FINAL part333E NDC National Distribution & Contracting, Inc. TRICLOSAN 3 mg/mL 43128-114_d9a4bd1d-cf81-45f2-9161-4aae74dbd9b7 43128-114 HUMAN OTC DRUG Pro Advantage Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130308 OTC MONOGRAPH NOT FINAL part333E NDC National Distribution & Contracting, Inc. ALCOHOL 620 mg/mL 43128-115_d0a26499-f003-4b70-8eb0-c9eccd863f1f 43128-115 HUMAN OTC DRUG Instant Hand Sanitizer Foam Ethyl Alcohol SOLUTION TOPICAL 20090813 OTC MONOGRAPH NOT FINAL part333 National Distribution & Contracting, Inc. ALCOHOL 62 mL/100mL 43128-118_7ed9372a-1c18-4a52-b81f-49d052835e4e 43128-118 HUMAN OTC DRUG Pro Advantage Instant Hand Sanitizer ALCOHOL GEL TOPICAL 20130308 OTC MONOGRAPH NOT FINAL part333E NDC National Distribution & Contracting, Inc. ALCOHOL 620 mg/mL 43128-128_3347d932-530e-4f8b-9236-45113efc9d09 43128-128 HUMAN OTC DRUG Pro Advantage Antibacterial TRICLOSAN LIQUID TOPICAL 20130424 OTC MONOGRAPH NOT FINAL part333E NDC National Distribution & Contracting, Inc. TRICLOSAN 3 mg/.001L 43128-208_f6bd39ce-0ca5-4d52-9c97-2a2998464c3f 43128-208 HUMAN OTC DRUG Antibacterial Foam Lavender Fragrance Triclosan SOAP TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333 National Distribution & Contracting TRICLOSAN .3 mg/100mL 43136-819_a60735f0-28cf-41fa-a00b-c5be933bee4e 43136-819 HUMAN OTC DRUG Cortisone Cream Intensive Healing Hydrocortisone CREAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part348 Tai Guk Pharmaceutical Company, Limited HYDROCORTISONE 10 mg/g 43196-510_35e13ed0-1005-436c-8865-dffd9ac46316 43196-510 HUMAN OTC DRUG OPI Antiseptic Foaming Hand Cleaner chloroxylenol LIQUID TOPICAL 20110307 OTC MONOGRAPH NOT FINAL part333E OPI Correctional Industries CHLOROXYLENOL 15.75 g/1000mL 43196-514_13af3e44-3912-4b77-a9f8-d9c1a5cf0093 43196-514 HUMAN OTC DRUG OPI Personal Care Supplies Instant Foaming Hand Sanitizer Non Alcohol Husky 514 SOLUTION TOPICAL 20091116 OTC MONOGRAPH NOT FINAL part333 OPI Correctional Industries BENZALKONIUM CHLORIDE 1 g/1000mL 43199-011_f9aaec2b-7ae2-459b-8649-afe760ae5fa2 43199-011 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL; SUBLINGUAL 20090921 UNAPPROVED DRUG OTHER County Line Pharmaceuticals, LLC HYOSCYAMINE SULFATE .125 mg/1 43199-012_f4dd9a8f-be58-4fac-b13b-b436589480ca 43199-012 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET, ORALLY DISINTEGRATING ORAL 20090921 UNAPPROVED DRUG OTHER County Line Pharmaceuticals, LLC HYOSCYAMINE SULFATE .125 mg/1 43199-013_480d688d-2103-443c-90cc-feb861bdce13 43199-013 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL 20091105 UNAPPROVED DRUG OTHER County Line Pharmaceuticals, LLC HYOSCYAMINE SULFATE .125 mg/1 43199-014_d2b55db1-be5f-4fe0-b31d-21bbe85a34f1 43199-014 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Extended-Release Hyoscyamine Sulfate Extended-Release TABLET ORAL 20100103 UNAPPROVED DRUG OTHER County Line Pharmaceuticals, LLC HYOSCYAMINE SULFATE .375 mg/1 43199-016_648e8cb5-c8b9-4854-9f38-d81d72d57f3c 43199-016 HUMAN PRESCRIPTION DRUG Antipyrine and Benzocaine Antipyrine and Benzocaine SOLUTION/ DROPS AURICULAR (OTIC) 20091125 UNAPPROVED DRUG OTHER County Line Pharmaceuticals, LLC ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 43199-020_52450d09-b77d-4bae-8d21-6394408e3f88 43199-020 HUMAN PRESCRIPTION DRUG Methenamine Hippurate Methenamine Hippurate TABLET ORAL 20100503 NDA NDA016151 County Line Pharmaceuticals, LLC METHENAMINE HIPPURATE 1 g/1 43199-021_73aaaea4-3219-497a-b6e8-f9f1034de7c4 43199-021 HUMAN PRESCRIPTION DRUG HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 20101129 UNAPPROVED DRUG OTHER County Line Pharmaceuticals, LLC HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43199-031_4bb3228b-e63f-4f65-8428-9ebf1b6a8bc5 43199-031 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide SOLUTION TOPICAL 20140228 NDA NDA018849 County Line Pharmaceuticals, LLC FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43199-037_b27501c9-a8b7-4e45-af4a-230466ebf654 43199-037 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride labetalol hydrochloride TABLET ORAL 20141201 NDA NDA018716 County Line Pharmaceuticals LLC LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43199-038_b27501c9-a8b7-4e45-af4a-230466ebf654 43199-038 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride labetalol hydrochloride TABLET ORAL 20141201 NDA NDA018716 County Line Pharmaceuticals LLC LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43199-039_b27501c9-a8b7-4e45-af4a-230466ebf654 43199-039 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride labetalol hydrochloride TABLET ORAL 20141201 NDA NDA018716 County Line Pharmaceuticals LLC LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43199-040_36cc9f7f-f41b-421e-ac35-0bc7e0507811 43199-040 HUMAN OTC DRUG Lidocaine Lidocaine CREAM TOPICAL 20140902 OTC MONOGRAPH NOT FINAL part348 County Line Pharmaceuticals, LLC LIDOCAINE 40 mg/g 43239-101_65dba14a-31fa-4eef-8853-e9462219a832 43239-101 HUMAN OTC DRUG SUNSCREEN SPF 30 ZINC OXIDE LOTION TOPICAL 20120318 OTC MONOGRAPH FINAL part352 ERBAVIVA INC. ZINC OXIDE 20 g/100g 43239-201_dc672b9a-24c6-40b7-95a7-de12e027adb4 43239-201 HUMAN OTC DRUG SUNSCREEN SPF 30 ZINC OXIDE LOTION TOPICAL 20120710 OTC MONOGRAPH FINAL part352 ERBAVIVA INC. ZINC OXIDE 20 g/100g 43251-0857_4b98792f-4481-46ed-8723-5e970f59d2fd 43251-0857 HUMAN OTC DRUG Natralia Eczema Moisturizing OATMEAL LOTION TOPICAL 20141201 OTC MONOGRAPH FINAL part347 LaCorium Health USA Inc. OATMEAL 20 mg/mL 43251-0864_37871023-f30a-473d-87ec-faf928f6ec98 43251-0864 HUMAN OTC DRUG Natralia Happy Little Bodies Eczema Relief OATMEAL CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part347 LaCorium Health USA Inc. OATMEAL 50 mg/g 43251-0871_fbac51bf-0968-4506-90d5-3c56ec30da11 43251-0871 HUMAN OTC DRUG Natralia Happy Little Bodies Eczema Moisturizing Oatmeal LOTION TOPICAL 20140210 OTC MONOGRAPH FINAL part347 LaCorium Health USA Inc. OATMEAL 20 mg/mL 43251-0888_de0de246-c20b-43f3-a2e9-6a14f378e8c8 43251-0888 HUMAN OTC DRUG Natralia Happy Little Bodies Eczema Body Wash Oatmeal GEL TOPICAL 20141201 OTC MONOGRAPH FINAL part347 LaCorium Health USA Inc. OATMEAL 10 mg/mL 43251-2231_f268a8f9-84db-453a-8e1f-1b8c692724d2 43251-2231 HUMAN OTC DRUG Flexitol Naturals Eczema and Psoriasis Sodium Borate, Graphite, Potassium Sulfate, and Sodium Chloride CREAM TOPICAL 20090103 UNAPPROVED HOMEOPATHIC LaCorium Health International Pty Ltd GRAPHITE; POTASSIUM SULFATE; SODIUM BORATE; SODIUM CHLORIDE 6; 3; 20; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43251-2241_8f91373e-28c2-4140-9b68-1424914c00f7 43251-2241 HUMAN OTC DRUG natralia eczema and psoriasis Sodium Borate, Graphite, Potassium Sulfate, and Sodium Chloride CREAM TOPICAL 20090301 UNAPPROVED HOMEOPATHIC LaCorium Health USA Inc. GRAPHITE; POTASSIUM SULFATE; SODIUM BORATE; SODIUM CHLORIDE 6; 3; 20; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43251-2281_f4b64631-3097-4136-8004-12ddfedc508e 43251-2281 HUMAN OTC DRUG Natralia Eczema and Psoriasis Sodium Borate, Graphite, Potassium Sulfate, and Sodium Chloride GEL TOPICAL 20090103 UNAPPROVED HOMEOPATHIC LaCorium Health USA Inc. GRAPHITE; POTASSIUM SULFATE; SODIUM BORATE; SODIUM CHLORIDE 6; 3; 20; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43251-3213_b76aa734-54d8-4a3f-aefd-963d68b1051c 43251-3213 HUMAN OTC DRUG Natralia Cramp Relief Methyl Salicylate GEL TOPICAL 20090301 UNAPPROVED DRUG OTHER Laderma Trading Pty Ltd METHYL SALICYLATE 105 mg/g 43251-3323_134b3385-4249-41ba-98b8-f800cf994114 43251-3323 HUMAN OTC DRUG natralia acne wash SILICON DIOXIDE and SODIUM CHLORIDE LIQUID TOPICAL 20090301 UNAPPROVED HOMEOPATHIC LaCorium Health International Pty Ltd SILICON DIOXIDE; SODIUM CHLORIDE 3; 12 [hp_X]/mL; [hp_X]/mL 43251-3333_b6a21ed9-7bb4-4fc5-b9be-d4b16eabe1fd 43251-3333 HUMAN OTC DRUG Natralia Acne CALENDULA OFFICINALIS FLOWER, CALCIUM CARBONATE, and PULSATILLA VULGARIS CREAM TOPICAL 20090301 UNAPPROVED HOMEOPATHIC LaCorium Health International Pty Ltd CALCIUM CARBONATE; CALENDULA OFFICINALIS FLOWER; PULSATILLA VULGARIS 3; 6; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g 43251-3340_32d36fb9-913b-4581-a2af-dc45211a4a4b 43251-3340 HUMAN OTC DRUG Flexitol Medicated Foot Tolnaftate CREAM TOPICAL 20120811 OTC MONOGRAPH FINAL part333C LaCorium Health International Pty Ltd TOLNAFTATE 1 g/100g 43251-3345_eedf04d3-cfb2-4546-8f4c-a2441a970de6 43251-3345 HUMAN OTC DRUG Natralia Anti-Itch Soothing OATMEAL and Menthol CREAM TOPICAL 20130110 OTC MONOGRAPH FINAL part347 LaCorium Health USA Inc MENTHOL; OATMEAL 6; 20 mg/g; mg/g 43251-3351_7a47e254-5846-47c7-8a7e-aad2484846ff 43251-3351 HUMAN OTC DRUG Flexitol Anti Fungal Undecylenic acid LIQUID TOPICAL 20090103 OTC MONOGRAPH FINAL part333C LaCorium Health International Pty Ltd UNDECYLENIC ACID 250 mg/mL 43251-3353_34e2e253-4b67-42aa-97a9-7e1ec09bac1c 43251-3353 HUMAN OTC DRUG FLEXITOL FIRST AID ARNICA MONTANA FLOWER and CHAMOMILE SPRAY TOPICAL 20100312 UNAPPROVED DRUG OTHER Laderma Trading Pty Ltd ARNICA MONTANA FLOWER; CHAMOMILE 2; 2 mg/mL; mg/mL 43251-3361_835610d3-ca3c-4326-a8dd-b970b5620f22 43251-3361 HUMAN OTC DRUG Natralia Anti Fungal Undecylenic acid LIQUID TOPICAL 20090103 OTC MONOGRAPH FINAL part333C Laderma Trading Pty Ltd UNDECYLENIC ACID 250 mg/mL 43251-3363_85dcf98b-ee55-40cc-a95a-e567ec4e53c4 43251-3363 HUMAN OTC DRUG FLEXITOL FIRST AID ARNICA MONTANA FLOWER and CHAMOMILE CREAM TOPICAL 20100312 UNAPPROVED DRUG OTHER Laderma Trading Pty Ltd ARNICA MONTANA FLOWER; CHAMOMILE 2; 2 mg/g; mg/g 43269-170_8d6289d0-f8c5-45d9-ac26-fafcc9e5b816 43269-170 HUMAN OTC DRUG SJ Antibacterial Hand Gel Ethyl Alcohol GEL TOPICAL 20091009 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-561_a859d2fa-e424-4156-9f2a-558c54bdf325 43269-561 HUMAN OTC DRUG SJ Antibacterial Hand Gel Ethyl Alcohol GEL TOPICAL 20091009 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-612_9855b35a-1ab5-4fde-a710-8cb22447d99d 43269-612 HUMAN OTC DRUG Target Fancy Nancy Antibacterial Hand Strawberry Parfait BENZALKONIUM CHLORIDE LOTION TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 g/100g 43269-613_53c3f0cc-314d-4743-b41a-41b6e605b69c 43269-613 HUMAN OTC DRUG Target Fancy Nancy Antibacterial Hand Glamorous Grape BENZALKONIUM CHLORIDE LOTION TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 g/100g 43269-614_e8f8b81e-4653-4a78-a755-a4518210c44e 43269-614 HUMAN OTC DRUG Claires Fancy Nancy Antibacterial Strawberry Parfait ALCOHOL GEL TOPICAL 20100519 OTC MONOGRAPH FINAL part333 SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-615_6639852c-e66e-4291-972a-8b9386ac27f8 43269-615 HUMAN OTC DRUG Claires Fancy Nancy Antibacterial Glamourous Grape ALCOHOL GEL TOPICAL 20100519 OTC MONOGRAPH FINAL part333 SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-616_6df0f3df-b831-4651-b43f-ced985402bd7 43269-616 HUMAN OTC DRUG Papaya Mango Antibacterial Hand Alcohol, Denatured GEL TOPICAL 20100611 OTC MONOGRAPH FINAL part333 SJ Creations, Inc. ALCOHOL 70 mL/100mL 43269-617_bc12e227-891d-40f9-9345-d294b75e9d97 43269-617 HUMAN OTC DRUG Papaya Mango Antibacterial Hand Alcohol, Denatured GEL TOPICAL 20100611 OTC MONOGRAPH FINAL part333 SJ Creations, Inc. ALCOHOL 70 mL/100mL 43269-618_da4c757a-b2d1-44c2-8751-7b312084d9c8 43269-618 HUMAN OTC DRUG Mandarin Nectar Antibacterial Foaming Handwash Triclosan LIQUID TOPICAL 20100623 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-619_57f716ba-a0ca-444b-8bf9-55e33c69067f 43269-619 HUMAN OTC DRUG Mango Spice Antibacterial Foaming Handwash Triclosan LIQUID TOPICAL 20100623 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-620_567d34ae-84c7-4f65-9760-f0968666d8ad 43269-620 HUMAN OTC DRUG Avocado Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20100623 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-621_6fdd33a4-b1fd-4c27-8c65-eef736ee2ec8 43269-621 HUMAN OTC DRUG Golden Pear Antibacterial Foaming Handwash Triclosan LIQUID TOPICAL 20100623 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-622_e19a8204-751d-4cf4-8653-aa0833fb6249 43269-622 HUMAN OTC DRUG Sweet Fig Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20100623 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-623_f5ddab1f-f0c4-4c66-bef9-dabcb53f6994 43269-623 HUMAN OTC DRUG Pineapple Pear Antibacterial Foaming Handwash Triclosan LIQUID TOPICAL 20100623 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-624_fb05c259-56de-4b08-a4ad-746adc12d42a 43269-624 HUMAN OTC DRUG Witchs Brew Antibacterial Hand ALCOHOL GEL TOPICAL 20100623 OTC MONOGRAPH FINAL part333 SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-625_c6d40e85-4c58-47e9-9d4f-099818f3c24c 43269-625 HUMAN OTC DRUG Scaredy Cat Antibacterial Hand ALCOHOL GEL TOPICAL 20100623 OTC MONOGRAPH FINAL part333 SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-626_ce4a7e0d-cd8d-491a-9ff1-5c0c4462f950 43269-626 HUMAN OTC DRUG Antibacterial Hand - Witchs Brew and Scaredy Cat ALCOHOL KIT 20101019 OTC MONOGRAPH NOT FINAL part333E SJ CREATIONS 43269-627_e46975c4-b24c-4b68-a61e-ee18644c4e40 43269-627 HUMAN OTC DRUG Antibacterial Hand Polar Mint and Arctic Blast ALCOHOL GEL TOPICAL 20100910 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-628_1bc980f1-6706-4978-b5aa-fafcffd7440c 43269-628 HUMAN OTC DRUG Antibacterial Hand Polar Mint ALCOHOL GEL TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-629_e4d88f68-9217-4def-92bd-4857bcbaf005 43269-629 HUMAN OTC DRUG Antibacterial Hand Arctic Blast ALCOHOL GEL TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-631_589e7e01-4fe8-425b-a806-ca262fc51414 43269-631 HUMAN OTC DRUG Antibacterial Hand Cranberry Spice BENZALKONIUM CHLORIDE LOTION TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 43269-632_d97c8161-6a1a-443f-b40d-2178f64932d0 43269-632 HUMAN OTC DRUG Antibacterial Hand Cranberry Spice ALCOHOL GEL TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-634_77d5d270-70f9-4787-ac48-ca4b1b3a5e63 43269-634 HUMAN OTC DRUG Antibacterial Hand Mistletoe and Mint BENZALKONIUM CHLORIDE LOTION TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 43269-635_c52b0a42-4102-4629-b121-e0945944fc20 43269-635 HUMAN OTC DRUG Antibacterial Hand Mistletoe and Mint ALCOHOL GEL TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-636_73d0ff31-6352-44e5-a137-884d441902f4 43269-636 HUMAN OTC DRUG Mandarin Nectar Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-637_37383a03-6786-485e-973b-effa4147e561 43269-637 HUMAN OTC DRUG Orange Cinnamon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-638_1a0c05b4-5c80-4af1-93b1-b1cda1eb1c9b 43269-638 HUMAN OTC DRUG Sweet Fig Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-639_a45b2a76-e8e3-4391-9cf9-a6229f5a5486 43269-639 HUMAN OTC DRUG Orange Clove Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-640_0e7fa435-1764-45e9-abdd-3ecce4ec998f 43269-640 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Olive Triclosan LIQUID TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-641_e5f0a52d-e7de-4676-a5b5-8f4ea8e92d02 43269-641 HUMAN OTC DRUG Antibacterial Hand Gift Set Icy Mint and Candy Cane ALCOHOL GEL TOPICAL 20100907 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-642_3a4710a4-0dce-4995-b02f-e6eb74ba1ca9 43269-642 HUMAN OTC DRUG Antibacterial Hand Icy Mint ALCOHOL GEL TOPICAL 20100907 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-643_390ff9df-8bad-41d4-bcb5-06262e1ed6b2 43269-643 HUMAN OTC DRUG Antibacterial Hand Candy Cane ALCOHOL GEL TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-645_737bafaf-4834-4950-85d8-eff5c0881cf8 43269-645 HUMAN OTC DRUG Antibacterial Hand Arctic blast ALCOHOL GEL TOPICAL 20100907 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-646_887b092b-3f37-4cbc-83d1-2b2759ed3c7e 43269-646 HUMAN OTC DRUG Antibacterial Hand Sugar Cookie BENZALKONIUM CHLORIDE LOTION TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 43269-648_f903b9a0-be74-4f32-86ee-e45cece2fd41 43269-648 HUMAN OTC DRUG Antibacterial Hand Gingerbread ALCOHOL GEL TOPICAL 20100909 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-649_aa8feffd-fbd8-4737-8237-b1dd0df08692 43269-649 HUMAN OTC DRUG Antibacterial Hand GB Sugar Cookie BENZALKONIUM CHLORIDE LOTION TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 43269-650_24de2f1c-d3c7-497b-b6a0-b27e9e5b44a1 43269-650 HUMAN OTC DRUG Sweet Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20101029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-652_7e5dd155-ce15-4dba-a1e1-b5accd37e645 43269-652 HUMAN OTC DRUG Mandarin Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20101102 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-653_f024a3e1-3c36-4bea-b899-495c60f97a56 43269-653 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20101102 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-655_c857fd1b-b27d-4585-b9c8-2a0e0ffccc66 43269-655 HUMAN OTC DRUG Vanilla Sugar Antibacterial Hand ALCOHOL GEL TOPICAL 20101109 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-656_3d1ba01d-048a-43ec-94f2-d4e7d41caab3 43269-656 HUMAN OTC DRUG Sweet Grape Antibacterial Hand ALCOHOL GEL TOPICAL 20101109 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-657_603011f0-7037-4abc-b6e0-1169df75ce8e 43269-657 HUMAN OTC DRUG Sun Blossom Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20101213 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-658_3bf03e81-c798-4e71-8d60-dfae5c2bed67 43269-658 HUMAN OTC DRUG Sandy Beaches Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20101213 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-659_483eaaa0-9176-41ec-b949-8637ba2d679a 43269-659 HUMAN OTC DRUG Lemon Zest Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20101213 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-660_83afc085-4392-4741-a64f-937352abe6db 43269-660 HUMAN OTC DRUG Jelly Bean Antibacterial Hand ALCOHOL GEL TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-661_410ee259-f3f8-437f-8e9b-b325d36e2c15 43269-661 HUMAN OTC DRUG Marshmallow Antibacterial Hand ALCOHOL GEL TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-662_22e64e7d-0c95-4b80-8983-b94c3e8d340f 43269-662 HUMAN OTC DRUG Creamsicle Antibacterial Hand BENZALKONIUM CHLORIDE LOTION TOPICAL 20110119 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 43269-663_178da967-7098-4809-b9a5-caf779d164d0 43269-663 HUMAN OTC DRUG Vanilla Bean Antibacterial Hand ALCOHOL GEL TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-664_de34dca9-5466-4222-9115-af4ba2f68861 43269-664 HUMAN OTC DRUG Orange Blossom Antibacterial Hand ALCOHOL GEL TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-665_c52c3897-c66b-424e-bbeb-2699a49cc677 43269-665 HUMAN OTC DRUG Jelly Bean Antibacterial Hand BENZALKONIUM CHLORIDE LOTION TOPICAL 20110119 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 43269-666_9bf07df6-15d6-465b-abd2-d2317a12c075 43269-666 HUMAN OTC DRUG Sea Mist Antibacterial Hand BENZALKONIUM CHLORIDE LOTION TOPICAL 20110223 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 43269-667_301ab715-ac35-4c85-a033-4ecfe9dc6f39 43269-667 HUMAN OTC DRUG Ocean Breeze Antibacterial Hand ALCOHOL GEL TOPICAL 20110223 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-668_eb8f43dd-440d-4c0e-925b-76f2bb418de2 43269-668 HUMAN OTC DRUG Ocean Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110215 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-669_0ad9ec15-ee9e-4896-8ed7-5a8926478265 43269-669 HUMAN OTC DRUG Kiwi Lime Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110223 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-670_7340fe37-42eb-4ad6-b5ea-d3657e95ce03 43269-670 HUMAN OTC DRUG Pineapple Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110223 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-671_566b09ab-7b31-46f9-8041-2fca95cd95d9 43269-671 HUMAN OTC DRUG Citrus Burst Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110223 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-672_e76bd3ad-2ee2-4602-9296-a825e61ed953 43269-672 HUMAN OTC DRUG Olive Leaf Antibacterial Creamy Hand Wash Triclosan LIQUID TOPICAL 20110303 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-673_c299e93c-472c-4e91-8dc1-ca7332880712 43269-673 HUMAN OTC DRUG Citrus Basil Antibacterial Cleansing Hand Wash Triclosan LIQUID TOPICAL 20110302 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-674_9eafce74-9577-4cc0-83b9-848482dade6b 43269-674 HUMAN OTC DRUG Lemon Verbena Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20110303 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-675_11cc0e39-4125-43eb-8696-936e84346b58 43269-675 HUMAN OTC DRUG Island Banana Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-676_7457c39a-e06e-495d-93cb-9a9c34e745a1 43269-676 HUMAN OTC DRUG Citrus Basil Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-677_130ca145-a362-40aa-9255-95c855c577e5 43269-677 HUMAN OTC DRUG Citrus Basil Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-678_25429827-f7f6-4f97-946d-cc9c91f50d7b 43269-678 HUMAN OTC DRUG Fresh Herbs Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20110404 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-679_cf82d4f4-6b64-4518-8862-8c66879bde6d 43269-679 HUMAN OTC DRUG Lemon Verbena Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-680_f70eff19-8ce6-4b37-ad41-568430368318 43269-680 HUMAN OTC DRUG Citrus Burst Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-681_88731459-e995-4795-995b-b017ad00c91d 43269-681 HUMAN OTC DRUG Creamy Peach Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-682_da4940d0-54e9-43cf-b43f-31d2b7b4e731 43269-682 HUMAN OTC DRUG Creamy Peach Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-684_a0a5a3cc-5da1-4ac1-8e8d-ee8e5302dd13 43269-684 HUMAN OTC DRUG Citrus Burst Antibacterial Cleansing Hand Wash Triclosan LIQUID TOPICAL 20110526 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-685_7cfb04c5-b021-40dc-9cbf-a552aeba331b 43269-685 HUMAN OTC DRUG Coconut Antibacterial Creamy Hand Wash Triclosan LIQUID TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-686_386333ac-6ea0-425d-9ccd-1e772adf882d 43269-686 HUMAN OTC DRUG Citrus Basil Antibacterial Creamy Hand Wash Triclosan LIQUID TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-687_b1564393-37b9-45f0-bb37-ff16a4c1d737 43269-687 HUMAN OTC DRUG Witches Brew Antibacterial Hand BENZALKONIUM CHLORIDE LOTION TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 43269-688_9ad2c7d2-a71a-4af7-886d-df01b4076749 43269-688 HUMAN OTC DRUG Boolicious Antibacterial Hand ALCOHOL GEL TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-689_c414ad4e-21af-4479-8f1f-40ad01b3d4a8 43269-689 HUMAN OTC DRUG Haunted Halloween Antibacterial Hand BENZALKONIUM CHLORIDE LOTION TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 43269-690_e2f1f740-3cf8-445e-9fa3-85a5ab9368c3 43269-690 HUMAN OTC DRUG Spooky Vanilla Antibacterial Hand ALCOHOL GEL TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-691_d98b55df-ae49-43d7-bbb6-af0f069c6854 43269-691 HUMAN OTC DRUG Wicked Candy Apple Antibacterial Hand BENZALKONIUM CHLORIDE LOTION TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 43269-692_be52cb57-7294-48da-a1f4-11a93abff844 43269-692 HUMAN OTC DRUG Trick or Treat Antibacterial Hand ALCOHOL GEL TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-693_b4767aa9-1d3d-4ce9-b985-52d9895752b3 43269-693 HUMAN OTC DRUG Trick or Treat Antibacterial Hand ALCOHOL GEL TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-694_4b7b969e-c38c-46f5-a54b-bb2b4db29341 43269-694 HUMAN OTC DRUG Boolicious Antibacterial Hand ALCOHOL GEL TOPICAL 20110630 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-695_dcfaf934-d525-46ec-91a5-c538f82cbc85 43269-695 HUMAN OTC DRUG Pumpkin Spice Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110629 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-696_e511c1ce-1f72-4b9e-933c-18ba86936a45 43269-696 HUMAN OTC DRUG Avocado Olive Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110629 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-697_29acf775-9578-41d3-875f-512bd12ada34 43269-697 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110629 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-698_97281b4d-5fb0-4463-9d74-b37d7bed7d1a 43269-698 HUMAN OTC DRUG Lemon Zest Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110727 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-699_72933e6a-3e9e-460c-842b-f27a57659549 43269-699 HUMAN OTC DRUG Mulling Spices Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110726 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-700_b0e9a8fa-834c-4a29-b45e-398db73a4497 43269-700 HUMAN OTC DRUG Pomegranate Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110727 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-710_0e993e04-b5b8-4941-a4cd-e0b9a3c52c36 43269-710 HUMAN OTC DRUG Golden Pear Antibacterial Cleansing Hand Wash Triclosan LIQUID TOPICAL 20110729 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-711_862979a7-8c72-4e9d-9872-1ba66648df8d 43269-711 HUMAN OTC DRUG Mistletoe and Mint Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110726 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-712_5973b444-17c0-41ad-936e-445e32f23903 43269-712 HUMAN OTC DRUG Cranberry Spice Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110729 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-713_852fe0fb-6919-4fcb-b44d-d3c006c67e21 43269-713 HUMAN OTC DRUG Orange Cinnamon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110729 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-714_080043ac-4f9f-44fc-9c35-58bf7c5a4275 43269-714 HUMAN OTC DRUG Pomegranate Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110729 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-715_537e38ee-0d30-4a5b-8e75-7aef4506eac1 43269-715 HUMAN OTC DRUG Kiwi Strawberry Foaming Hand Wash Triclosan LIQUID TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-716_c1fceb67-2a51-4c10-93ad-909ecd26cf85 43269-716 HUMAN OTC DRUG Citrus Burst Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-717_e1d3d80c-1fc0-4fc2-b919-4a19e306ac8c 43269-717 HUMAN OTC DRUG Olive Leaf Antibacterial Cleansing Hand Wash Triclosan LIQUID TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-718_430ceedf-0f47-4ba4-a35f-b724eda85d6d 43269-718 HUMAN OTC DRUG Paisley Peach Antibacterial Hand Moisturizer BENZALKONIUM CHLORIDE LOTION TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 43269-719_9189814d-617b-4c38-a12e-6558dbfb8c8e 43269-719 HUMAN OTC DRUG Daisy Blossom Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-720_8d561f9f-1c81-4b98-af23-cb7eb6ee5cba 43269-720 HUMAN OTC DRUG Sweet Water Antibacterial Hand Moisturizer BENZALKONIUM CHLORIDE LOTION TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 43269-721_9e5a778b-2c1d-4233-af2b-1382a17cd278 43269-721 HUMAN OTC DRUG Green Tea Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-723_5d5024c7-372c-470f-b07b-3218953d2939 43269-723 HUMAN OTC DRUG Pomegranate Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-724_bc9d88d6-a5d3-4397-bb8e-10b677dca6c1 43269-724 HUMAN OTC DRUG Orange Bliss Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-725_41d580dd-0267-4f8e-85a5-467cc138c967 43269-725 HUMAN OTC DRUG Citrus Burst Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-726_fc4428bc-3f3f-4be3-b592-c15ee30475d9 43269-726 HUMAN OTC DRUG Country Apple Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-727_2f600d63-c41d-494f-bb78-b766cdcf160d 43269-727 HUMAN OTC DRUG Honey Apple Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111206 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-728_4cac3d67-5d45-4066-92c4-bc50944036c9 43269-728 HUMAN OTC DRUG Lavender Sage Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-729_f62b7d63-255c-4bb3-9b6e-3c4fa2da575b 43269-729 HUMAN OTC DRUG Sandy Beaches Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111214 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-730_b01be39b-4fc8-46a2-8450-e194c06ffb78 43269-730 HUMAN OTC DRUG Island Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111214 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-731_af86f827-5de5-489b-b1d5-48afc1bf78c1 43269-731 HUMAN OTC DRUG Island Blossom Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111214 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-732_eef3940e-e8c8-4ccc-ac1f-2e75661559c5 43269-732 HUMAN OTC DRUG Citrus, Basil and Lime Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111215 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-733_e79794fd-8106-46a5-acdd-ee8e3618c9e0 43269-733 HUMAN OTC DRUG Lemon Zest Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111214 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-734_3ce0c5fa-3b50-4529-bfea-35c01648e9cd 43269-734 HUMAN OTC DRUG Pomegranate Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111214 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-735_ee423e7f-e88b-4bf1-9118-49c215e4a1e0 43269-735 HUMAN OTC DRUG Papaya Mango Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120105 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-736_45cf764f-fe76-4127-bfff-2f4ed9806947 43269-736 HUMAN OTC DRUG Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-737_3e72953c-0a1e-46e8-a191-e180992967ed 43269-737 HUMAN OTC DRUG Olive Oil Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-738_cd7300a2-de2f-4608-aff1-6a570edc167a 43269-738 HUMAN OTC DRUG Pink Peony Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-739_a960d9cc-df2b-43d0-9429-8282384af38d 43269-739 HUMAN OTC DRUG Sandy Beaches Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-740_1c4ee3ac-7d6b-4e7d-951a-0abb6afbd5c1 43269-740 HUMAN OTC DRUG Lemon Zest Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-741_70de8734-b8f5-4cfe-b3fe-661267d7c065 43269-741 HUMAN OTC DRUG Sweet Papaya Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-742_16a019e1-2a93-4d72-9fe6-5139ae9d64b2 43269-742 HUMAN OTC DRUG Orange Basil and Lime Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-743_72e14e78-ffea-4e9d-a8f1-ba45c37b5222 43269-743 HUMAN OTC DRUG Honey Vanilla Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-744_3cf0ce5b-00d1-4004-a323-ef439b370a3d 43269-744 HUMAN OTC DRUG Lavender and Sage Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-745_2372cd20-15ee-416e-9454-a5af5a7f32a2 43269-745 HUMAN OTC DRUG Sweet Daisy Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20120112 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-746_0dce062d-c669-4c99-a9b2-7f528275b394 43269-746 HUMAN OTC DRUG Vanilla Sugar Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20120112 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-747_e1d54e22-7d3b-4e26-aa0b-dcdaabd354dc 43269-747 HUMAN OTC DRUG Sweet Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120125 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-748_4313767c-93e5-488b-9dbd-402be9c78d16 43269-748 HUMAN OTC DRUG Lemon Verbena Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-749_71912693-8e16-4b5b-bd6f-78f640779daa 43269-749 HUMAN OTC DRUG Mandarin Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-750_bc5394ed-c908-4faf-b7ac-83cf90842de6 43269-750 HUMAN OTC DRUG Olive Oil and Lemon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-751_5640caf0-90e1-4245-804a-2129a19c2993 43269-751 HUMAN OTC DRUG Tuscan Lemon Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-752_58b533f5-7716-4b5b-8c7b-8b03354eb70d 43269-752 HUMAN OTC DRUG Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-753_5873824e-66cb-41a4-8281-e76eee21c865 43269-753 HUMAN OTC DRUG Juicy Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-754_439224e6-9a1d-43aa-9223-625d907e349e 43269-754 HUMAN OTC DRUG Kiwi Strawberry Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-755_fff1b5f2-ee6a-44cb-9f69-0fc378d1f8eb 43269-755 HUMAN OTC DRUG Lemon Basil Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-757_3c15ac70-86e9-4f0f-8ec5-f389ee0454e0 43269-757 HUMAN OTC DRUG Fresh Herbs Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-758_97ac88a6-c49d-4f5c-b2ea-5b88494b7f1b 43269-758 HUMAN OTC DRUG Sweet Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120220 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-759_78e7b3e4-8dc0-4aba-84c0-7d62206993f4 43269-759 HUMAN OTC DRUG Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20120305 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-760_79a55a89-af99-4dc9-8cb9-ea887a1703a1 43269-760 HUMAN OTC DRUG Citrus and Olive Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-761_47cc9f87-0962-4612-9d1f-50228f3595a5 43269-761 HUMAN OTC DRUG Summer Citrus Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-762_c73fee08-c67f-4c62-916b-1d886a4a61f4 43269-762 HUMAN OTC DRUG Basil and Plum Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120320 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-763_58140c5e-c858-4635-88f7-b68ab1d2f430 43269-763 HUMAN OTC DRUG Dewberry Burst Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-764_b52472e7-99f7-4331-866f-f06b22661b88 43269-764 HUMAN OTC DRUG Jasmine Mint Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-765_6c2af1f6-451c-4050-8372-dd8d7ba90f3b 43269-765 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-766_94e4fe2f-0d8b-4b87-b9f4-beaac3b9fea8 43269-766 HUMAN OTC DRUG Citrus Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-767_4bd11289-5e4f-47ee-bd8c-b81069b0a275 43269-767 HUMAN OTC DRUG Citrus Burst Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-768_f08e5fce-38df-461c-b3e3-c24d974ebb45 43269-768 HUMAN OTC DRUG Citrus Basil and Lime Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-769_92d33565-92eb-49de-b735-d3120142f4d1 43269-769 HUMAN OTC DRUG Lemon Drop Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-770_88dc71de-474e-4b56-9173-da22ee30e022 43269-770 HUMAN OTC DRUG Citrus and Casaba Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-771_e5ad7085-6916-4947-8a60-1c10757f7d2d 43269-771 HUMAN OTC DRUG Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20120322 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-772_767de4c0-54d3-41ab-9150-7a0e76787928 43269-772 HUMAN OTC DRUG Cucumber Lime Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120420 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-773_59dfff19-3906-45b6-8077-04b27632f8bd 43269-773 HUMAN OTC DRUG Lemon Verbena Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120420 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-774_33791081-be76-404b-8708-cbbd77272b07 43269-774 HUMAN OTC DRUG Macaroon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120420 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-775_001143a2-47b8-467a-ace7-f60c34e83831 43269-775 HUMAN OTC DRUG Summer Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120420 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-776_1fea9639-355a-4e22-af72-6820fe2a7445 43269-776 HUMAN OTC DRUG Citrus Burst Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-777_d8be7e33-87ac-49a1-a3c8-439db1cc1dfa 43269-777 HUMAN OTC DRUG Citrus and Aloe Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-778_17b541ed-0914-49d3-8378-2af3f999ff19 43269-778 HUMAN OTC DRUG Cucumber and Lime Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-779_8af1836b-f9c1-4371-af90-b1918b7454a6 43269-779 HUMAN OTC DRUG Vineyard Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-780_90ee8c86-6177-4c9e-968c-8f308d3e020f 43269-780 HUMAN OTC DRUG Fresh Linen Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-781_5b066d06-7243-4351-bf31-b6ae294a795a 43269-781 HUMAN OTC DRUG Island Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-782_0d59bc33-4f0e-4932-822d-22d779ed9dd9 43269-782 HUMAN OTC DRUG Summer Bouquet Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-783_282a4fe0-7aa9-4bb4-a7df-5df28b35e14b 43269-783 HUMAN OTC DRUG Apple Spice Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-784_9470d3d0-143b-4123-a099-554d42fb796f 43269-784 HUMAN OTC DRUG Olive Oil and Lemon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-785_318b4ab0-937a-461a-a454-03d48489e6e4 43269-785 HUMAN OTC DRUG Summer Berry Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-786_08a094de-b9d6-4af0-a18a-c53f609c2ed0 43269-786 HUMAN OTC DRUG Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-787_2a6ce1f6-3932-46e9-9c94-06a242ff0a03 43269-787 HUMAN OTC DRUG Lemon Fresh Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-788_43e78131-25b0-4dad-bb99-a76ae4c21118 43269-788 HUMAN OTC DRUG Pomegranate Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL 43269-790_017a1e04-740e-4b15-b8af-d450f5e824a1 43269-790 HUMAN OTC DRUG Spiced Cider Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120709 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-791_b11f801b-0ee9-4acc-af46-a0aaf5154fc3 43269-791 HUMAN OTC DRUG Pumpkin Spice Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120709 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-792_f5e675b1-0ded-4b68-98e5-460532ce2dd4 43269-792 HUMAN OTC DRUG Lemon Zest Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120709 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-793_b34ed3c4-50ad-41bd-9963-873d27a21b74 43269-793 HUMAN OTC DRUG Autumn Medley Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120709 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-794_89a56adc-6bee-491c-ad79-746a0d410c97 43269-794 HUMAN OTC DRUG Mint and Aloe Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120709 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-795_4fa84e2b-3bda-42c4-a3b1-fdd6cf4b2cb3 43269-795 HUMAN OTC DRUG Pumpkin Spice Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20120703 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-796_b9649d9b-2972-497e-a7ff-b979e97aba1d 43269-796 HUMAN OTC DRUG Spooky Vanilla Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20120703 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL 43269-797_b5bfa7eb-9f77-4781-bd5a-976e299eb1eb 43269-797 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-798_b4e1badd-9255-42a8-81a4-cb45306af08b 43269-798 HUMAN OTC DRUG Cranberry Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-799_2a2d7b44-3217-4c7e-9f5f-8218b46e4d78 43269-799 HUMAN OTC DRUG Orange Blossom Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-800_37393fb2-1733-4dd2-a271-43c8567b7f19 43269-800 HUMAN OTC DRUG Ginger Blossom Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-801_5974190c-1ad8-4fcd-98b0-bb435d77d0f7 43269-801 HUMAN OTC DRUG Fresh Lemon Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-802_e4b40a21-e9ab-4541-81e2-520f6378eb42 43269-802 HUMAN OTC DRUG Wild Strawberry Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-803_d46c09f0-1008-4c12-8421-09ef49b5f5bb 43269-803 HUMAN OTC DRUG Honey Vanilla Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-804_058c3aba-56f0-407d-9ad6-d77bfb982195 43269-804 HUMAN OTC DRUG Vineyard Grape Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-805_8507e78b-d549-467e-a1fb-a3c919684463 43269-805 HUMAN OTC DRUG Apple Spice Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-806_a39b8091-d1e1-49bc-aa37-4e3c02d52d1b 43269-806 HUMAN OTC DRUG Fresh Blueberry Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-807_32e56689-51b2-452b-8399-12339681a280 43269-807 HUMAN OTC DRUG Cranberry Spice Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-808_878e6bdb-9fb1-471b-a550-a32359c136f7 43269-808 HUMAN OTC DRUG Fresh Lemon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-809_780d8287-9a0b-4c60-944b-4065178f96cf 43269-809 HUMAN OTC DRUG Lemon Drop Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-810_f0e2eeb5-1b54-4905-8f5e-d3a04d632f7a 43269-810 HUMAN OTC DRUG Blueberry Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-811_0c2ea094-ed2b-4203-8a82-48a713ca6426 43269-811 HUMAN OTC DRUG Sweet Honey Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-812_06a8222d-f0f7-45eb-8a63-c72179dced1b 43269-812 HUMAN OTC DRUG Grape Vineyard Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-813_9ad214da-9432-4197-ae1f-e14e01bd6039 43269-813 HUMAN OTC DRUG Cinnamon and Cream Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-814_4d148b97-b2ec-487d-9455-2b5888c47573 43269-814 HUMAN OTC DRUG Apple Cider Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-815_ddfb0680-9173-4c06-a77a-8cc302ad634a 43269-815 HUMAN OTC DRUG Cinnamon Clove Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-816_f235a7af-780c-40b6-a16b-f3eb5bdb2950 43269-816 HUMAN OTC DRUG Iced Vanilla Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-817_f0ff6092-6ecc-4304-bf55-6bcdf17f951a 43269-817 HUMAN OTC DRUG Pomegranate Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-818_4dbad500-2957-4763-adc4-2ee9b389c6e9 43269-818 HUMAN OTC DRUG Vanilla Cream Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-819_2021a487-d00f-4feb-8738-5831a7e95dfe 43269-819 HUMAN OTC DRUG Pomegranate Spice Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-820_910e62c4-1ca8-4333-9023-788b400aeeb9 43269-820 HUMAN OTC DRUG Cranberry Cream Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-821_b286f7b1-35a3-4395-8599-787f6138ed52 43269-821 HUMAN OTC DRUG Sugar Cookie Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-822_17901d12-1b19-435b-9167-603f211875d7 43269-822 HUMAN OTC DRUG Lemongrass Tea Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-823_09230cb8-3d57-4949-a512-8d81fb590fd6 43269-823 HUMAN OTC DRUG Lemongrass Tea Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-824_9b558183-a77c-4e80-99f5-1b0da0fd6c41 43269-824 HUMAN OTC DRUG Cinnamon Sticks Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-825_200511bc-ac4b-4466-9502-36d9391f8d45 43269-825 HUMAN OTC DRUG Cranberry Spice Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-826_1022db75-de29-432d-ae82-31e0e0b66d4d 43269-826 HUMAN OTC DRUG Sweet Golden Pear Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-827_f9eed34b-cb4e-4f43-bff6-0edb9f538b87 43269-827 HUMAN OTC DRUG Blueberry Dream Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-828_890159fa-d806-4d85-9a0d-89bda82b650d 43269-828 HUMAN OTC DRUG Vineyard Grape Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-829_56cc3935-8566-4001-ae32-c119a46e088d 43269-829 HUMAN OTC DRUG Lemon and Basil Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-830_5e84212d-ad53-4df6-86da-86d86b3b04fe 43269-830 HUMAN OTC DRUG Ginger and Lemon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-831_d336932f-e53f-41f7-b3f4-fe3a3a3e2bfa 43269-831 HUMAN OTC DRUG Mint and Aloe Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-832_c192cc7c-f8e1-427e-9c3d-c0fa50ee7bbe 43269-832 HUMAN OTC DRUG Manderin Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120904 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-833_c6f0a2fd-22f6-45a0-ac46-65cbf6919e6a 43269-833 HUMAN OTC DRUG Sugar Cookie Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120905 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-834_586c3e57-17d7-484f-9c70-e6592b27cc79 43269-834 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-835_f39d47dc-534c-42ee-a762-9cc34c71bb8b 43269-835 HUMAN OTC DRUG Lemon Verbeba Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-836_5c7147c2-361b-421c-b535-562e101f96c8 43269-836 HUMAN OTC DRUG Sweet Fig Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-837_9bc06661-c7cb-4de9-b6f5-a239999f0d00 43269-837 HUMAN OTC DRUG Apple Cider Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121003 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-838_93b163c6-8a44-455a-856d-b5fe44bcfd26 43269-838 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL 43269-839_6affcf17-b072-4397-b0d3-c8010b1c7729 43269-839 HUMAN OTC DRUG Citrus and Olive Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121003 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-840_de2742ae-017b-4a48-948c-8bd3f0f64be5 43269-840 HUMAN OTC DRUG Tuscan Lemon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121003 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-841_5efc7460-9361-4fcb-bb9a-7914c86f220e 43269-841 HUMAN OTC DRUG Fresh Herbs Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121003 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-842_bff82f50-b4f1-458b-ba79-ec225e47c724 43269-842 HUMAN OTC DRUG Ginger Blossom Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-843_8649a672-261d-44fe-876f-a680b18a4ccf 43269-843 HUMAN OTC DRUG Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-844_e8783840-d614-4780-b45c-1e53e066fe0e 43269-844 HUMAN OTC DRUG Passion Flower Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-845_3060fabf-5ca9-4a62-bb60-8c23f7a46bbc 43269-845 HUMAN OTC DRUG Sea Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-846_6a3448fd-bf6f-45d4-862b-20b405a862c3 43269-846 HUMAN OTC DRUG Citrus Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-847_6d6afc79-459e-43c0-a239-fa133536ac46 43269-847 HUMAN OTC DRUG Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-848_f8c6827c-ac11-4a74-b278-7ed65b371a2b 43269-848 HUMAN OTC DRUG Vanilla Honey Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-849_9ec4323b-f9b4-4705-a118-aa5e31f02bbd 43269-849 HUMAN OTC DRUG Apple Spice Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-850_e7f7e9d8-9177-4aec-994f-46c31cbce342 43269-850 HUMAN OTC DRUG Honey Almond Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-851_0091f9e7-e776-4f4f-91b0-e85e5ae8db2e 43269-851 HUMAN OTC DRUG Lemon Zest Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-852_5af744e2-8281-4cef-a8fa-37e9909f9e59 43269-852 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-853_21a0f79c-a139-43a3-8f7b-42872af1bcae 43269-853 HUMAN OTC DRUG Sage and Citrus Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-854_bcf94ee3-5452-463f-81db-60cbd38b8ba9 43269-854 HUMAN OTC DRUG Peaches and Cream Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-855_c05fcc04-8f0f-48a0-b16b-ffd39fd0894c 43269-855 HUMAN OTC DRUG Pomegranate Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-856_fb1087e8-1048-4938-8938-041672fa839a 43269-856 HUMAN OTC DRUG Citrus Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-857_f269de57-ce5d-40ac-9f0d-53dc8d6bf4a8 43269-857 HUMAN OTC DRUG Fresh Linen Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-858_f273db77-1668-4702-a702-72165919236e 43269-858 HUMAN OTC DRUG Fresh Lime Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121129 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-859_a1669b59-6a33-4ba0-af9b-93e1bd4667f1 43269-859 HUMAN OTC DRUG Olive Oil Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121129 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-860_1ff4c6e0-55f7-49c4-b455-0baa2cbd95c1 43269-860 HUMAN OTC DRUG Green Tea and Ginseng Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-861_0d0d1c10-10d2-4d80-a1cc-619810be647c 43269-861 HUMAN OTC DRUG Lemon Zest Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-862_60928ad3-b701-41fb-9277-d8938f371d42 43269-862 HUMAN OTC DRUG Sweet Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-863_56219b66-3441-48c4-8b33-e474dc9bb0ec 43269-863 HUMAN OTC DRUG Avocado Lime Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130218 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-864_7164b04b-b2a5-43b9-b7e7-9101532270f7 43269-864 HUMAN OTC DRUG Sweet Fig Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130218 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-865_88f01ed1-5227-4a53-b336-81b18f6e6b49 43269-865 HUMAN OTC DRUG Lemon Fresh Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130218 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-866_f767a2f4-63c4-4db2-9221-677ac2148738 43269-866 HUMAN OTC DRUG Fruit Medley Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130218 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-867_f81d7145-1e6f-4eb4-aac4-c3fa6bcc73c0 43269-867 HUMAN OTC DRUG Sweet Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130218 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-868_1cafd653-97e4-42e9-a17e-a55dfaa1e65b 43269-868 HUMAN OTC DRUG Cucumber Melon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-869_8b72b5d5-5a7b-45bd-8fdc-582af87678de 43269-869 HUMAN OTC DRUG Mandarin Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-870_7bc0e2c2-b3c8-4152-a472-8a6ee5764dce 43269-870 HUMAN OTC DRUG French Vanilla and Lavender Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-871_caae74cb-b5b6-4bb5-823c-67e99b5e0749 43269-871 HUMAN OTC DRUG Lemon and Olive Oil Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-872_208ae140-a310-4e48-b7aa-52ff1885cb4e 43269-872 HUMAN OTC DRUG Sweet Peaches Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-873_4894efc6-1205-4d1c-b5a9-1ee56d158cdb 43269-873 HUMAN OTC DRUG Lemon Verbena Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-874_7e49d446-7df6-41bb-a6ec-a91adacf86fe 43269-874 HUMAN OTC DRUG Island Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130416 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-875_050c632c-f382-46f0-b24a-7586a1041830 43269-875 HUMAN OTC DRUG Lavender Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130426 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-876_c8b84368-2093-4c5e-a92e-0caaa83d934e 43269-876 HUMAN OTC DRUG Lemon Zest Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130426 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-877_8ef416c4-49ff-4019-89ff-622ac11f7931 43269-877 HUMAN OTC DRUG Lemon and Basil Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130422 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-878_fe96506a-7a65-4db8-baa4-ecd374736bd6 43269-878 HUMAN OTC DRUG Mandarin Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130426 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-879_a8b049b3-d316-4456-a58b-c0adf56af0c5 43269-879 HUMAN OTC DRUG Sweet Red Apple Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130426 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-880_542aa87f-46c6-4ab1-917c-d87ea030d187 43269-880 HUMAN OTC DRUG Mischievous Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130625 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-881_9e0f6f7f-c958-4798-88fe-256fcef1b546 43269-881 HUMAN OTC DRUG Pumpkin Seeds Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130625 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-882_da9d3c46-075d-4399-b04d-eea528e8a034 43269-882 HUMAN OTC DRUG Spooky Sugar Cookie Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130625 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-883_3347fc18-6091-47ce-9322-d11f4c6046c6 43269-883 HUMAN OTC DRUG Trick or Treat Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130625 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-884_b4d65276-e8e7-4b05-82fa-920dddb7f0ad 43269-884 HUMAN OTC DRUG Boolicious Antibacterial Hand Sanitizer BENZALKONIUM CHLORIDE GEL TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL .65 mg/100mL 43269-885_f51f4bcc-6a4d-4680-97cb-19f3e4012782 43269-885 HUMAN OTC DRUG Boolicious Antibacterial Hand Moisturizer BENZALKONIUM CHLORIDE LOTION TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mg/100mL 43269-886_6db0491c-1fbe-45d0-a896-e0fdc31d7800 43269-886 HUMAN OTC DRUG Spooky PUmpkin Antibacterial Hand Sanitizer BENZALKONIUM CHLORIDE GEL TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL .65 mg/100mL 43269-887_9a99dd6b-ed3c-465b-aa4c-b5189bb4bcc9 43269-887 HUMAN OTC DRUG Spooky Pumpkin Antibacterial Hand Moisturizer BENZALKONIUM CHLORIDE LOTION TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mg/100mL 43269-888_89cd51df-b787-4bf2-8e7b-fc4c802da901 43269-888 HUMAN OTC DRUG Haunted Halloween Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-889_1e24e577-77fc-4388-8fcf-298cc17f8cb4 43269-889 HUMAN OTC DRUG Spiced Pumpkin Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-890_1e85afac-7ba4-464e-a39a-8326e5878627 43269-890 HUMAN OTC DRUG Witchs Brew Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-891_c7b1e013-1ebb-478e-aeb2-a7bb648308ef 43269-891 HUMAN OTC DRUG Apple Cider Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-892_532b5245-7e9f-4052-b7e2-e4a3348e5644 43269-892 HUMAN OTC DRUG Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-893_7bf3b0cd-6bb8-4253-8dba-ca08790e6b83 43269-893 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-894_aabffcfc-1d8b-4b03-8399-c89fc3cd6a38 43269-894 HUMAN OTC DRUG Cranberry Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-895_25159486-8b00-487b-a3b7-adccb5d897fb 43269-895 HUMAN OTC DRUG Harvest Grape Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-896_2c38a83f-b043-407f-955f-a9f192d16b50 43269-896 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-897_b25da841-7c42-47fa-875b-cf7026c27011 43269-897 HUMAN OTC DRUG Holiday Treats Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130925 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-898_9ff2c718-1e0b-4064-941e-eb22ffb5b4f1 43269-898 HUMAN OTC DRUG Mistletoe and Mint Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130925 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-899_56d404ec-8c08-4a83-b84a-54eacc722303 43269-899 HUMAN OTC DRUG Snow Drop Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130925 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL 43269-900_ae426089-b1fa-4551-8765-50497e67a9d1 43269-900 HUMAN OTC DRUG Mischievous Orange Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140620 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL 43269-901_b476c00f-b620-4d4a-9f68-a66576e3fcd3 43269-901 HUMAN OTC DRUG Pumpkin Seeds Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140620 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL 43269-902_c4d47585-c351-4e3c-bb2b-a28fb463bbb2 43269-902 HUMAN OTC DRUG Trick or Treat Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140620 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL 43269-903_4d5babd5-0781-4f7e-93c6-631eb1eb3ed9 43269-903 HUMAN OTC DRUG Blackberry Vanilla Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140620 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL 43269-904_d7a0fc90-1f5e-4f0c-b90a-5edabaa392d3 43269-904 HUMAN OTC DRUG Spooky Sugar Cookie Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140620 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL 43269-905_1d0379ee-cb30-47d6-9bb5-0901ade18316 43269-905 HUMAN OTC DRUG Holiday Treats Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140821 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL 43269-906_2deb800f-4593-42e2-8d24-a7683f7c5128 43269-906 HUMAN OTC DRUG Mistletoe and Mint Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140821 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL 43269-907_3003cbf3-de47-4b9e-bf74-7494aeee1030 43269-907 HUMAN OTC DRUG Cinnamon Spice Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140821 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL 43269-908_dacc164c-2de3-4baa-bd66-6d7ac5cb9b19 43269-908 HUMAN OTC DRUG Mistletoe Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140821 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL 43275-100_13777ecf-9045-4425-abc6-79df5fbe0797 43275-100 HUMAN OTC DRUG NUGA TOURCIA SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110901 OTC MONOGRAPH FINAL part355 NUGA MEDICAL CO., LTD. SODIUM MONOFLUOROPHOSPHATE .18 g/180g 43275-110_fb48753b-f6bd-4146-b209-9773c75ad2a5 43275-110 HUMAN OTC DRUG TOURCIA DIMETHICONE SHAMPOO TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NUGA MEDICAL CO., LTD. DIMETHICONE 11.4 mg/380mL 43275-120_dca4705f-3285-4008-9196-d2a3b76616ce 43275-120 HUMAN OTC DRUG TOURCIA BODY WASH ALLANTOIN SOLUTION TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NUGA MEDICAL CO., LTD. ALLANTOIN 1.9 mg/380mL 43275-130_a6ec06c8-677e-40cd-8817-97c90c09d531 43275-130 HUMAN OTC DRUG TOURCIA CONDITIONER DIMETHICONE SOLUTION TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NUGA MEDICAL CO., LTD. DIMETHICONE 15.2 mg/380mL 43275-140_d2ddaca8-2e93-4299-b0a4-afa7447fe334 43275-140 HUMAN OTC DRUG TOURMANIUM BB SPF30 PA PLUS PLUS Zinc Oxide CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NUGA MEDICAL CO., LTD. ZINC OXIDE 1.15 g/40mL 43275-150_b17af44c-87cf-4216-b7a5-f2171e3f7adf 43275-150 HUMAN OTC DRUG TOURCIA NUTRI DIMETHICONE CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part347 NUGA MEDICAL CO., LTD. DIMETHICONE 1 mg/50mL 43275-160_ea39ac03-64cf-40fe-ac09-2fcb98522cdb 43275-160 HUMAN OTC DRUG TOURCIA NUTRI EMULSION ALLANTOIN CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part347 NUGA MEDICAL CO., LTD. ALLANTOIN .65 mg/130mL 43275-170_d9101e39-4c13-480e-8197-f01a6280161d 43275-170 HUMAN OTC DRUG TOURCIA NUTRI ESSENCE ALLANTOIN CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part347 NUGA MEDICAL CO., LTD. ALLANTOIN .15 mg/30mL 43275-180_dbabb6fd-f35b-4cbc-b9be-5d3682c611ba 43275-180 HUMAN OTC DRUG TOURCIA NUTRI EYE ALLANTOIN CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part347 NUGA MEDICAL CO., LTD. ALLANTOIN .15 mg/30mL 43275-190_4db8c870-92f3-4474-a28b-90057870454a 43275-190 HUMAN OTC DRUG TOURCIA NUTRI TONER ALLANTOIN CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part347 NUGA MEDICAL CO., LTD. ALLANTOIN .75 mg/150mL 43276-0001_727ec7db-a658-428e-af99-6e6be273d668 43276-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090801 UNAPPROVED MEDICAL GAS Support Medical Company OXYGEN 99 L/100L 43288-104_f9c93174-b497-41c9-8db5-b08def5b2466 43288-104 HUMAN PRESCRIPTION DRUG Zuplenz ONDANSETRON FILM, SOLUBLE ORAL 20100705 20151130 NDA NDA022524 Praelia Pharmaceuticals Inc ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 43288-108_f9c93174-b497-41c9-8db5-b08def5b2466 43288-108 HUMAN PRESCRIPTION DRUG Zuplenz ONDANSETRON FILM, SOLUBLE ORAL 20100705 20151130 NDA NDA022524 Praelia Pharmaceuticals Inc ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 43288-250_dfe54d3b-c248-4156-9660-14a3c229cb4d 43288-250 HUMAN PRESCRIPTION DRUG ORAVIG miconazole TABLET BUCCAL 20121101 NDA NDA022404 Praelia Pharmaceuticals Inc MICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 43305-1030_fff2ba80-8f3d-4fd7-a021-073a4a69bcc6 43305-1030 HUMAN PRESCRIPTION DRUG LIDOCAINE HCl Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20120515 ANDA ANDA088390 Pearson Dental EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 43305-1080_dc108438-2fa7-4c84-b6e8-82c89ae8ec06 43305-1080 HUMAN PRESCRIPTION DRUG Pearson Mepivacaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20120515 ANDA ANDA088387 Pearson Dental MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 43314-001_028d48ef-033d-49dc-8469-cde41d66ccf2 43314-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20030101 UNAPPROVED MEDICAL GAS Sound Oxygen Service, Inc. OXYGEN 99 L/100L 43319-010_ea8004a1-63df-424c-9523-9ea016768aee 43319-010 HUMAN OTC DRUG GOONGSECRET BABY SUN SPF35 PA PLUS PLUS PLUS ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20120301 OTC MONOGRAPH FINAL part352 0to7 Inc TITANIUM DIOXIDE; ZINC OXIDE 5.632; 9.216 g/80g; g/80g 43319-020_42d12822-4dea-4fca-9361-f22a970520de 43319-020 HUMAN OTC DRUG GOONGSECRET DAILY FACE SUN SPF25 PA PLUS PLUS TITANIUM DIOXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 0to7 Inc TITANIUM DIOXIDE 2.886 g/60g 43319-030_a1dfba7b-792b-4bad-bf81-a2b6e5c0c12c 43319-030 HUMAN OTC DRUG GOONGSECRET CALMING BATH ALLANTOIN POWDER TOPICAL 20120301 OTC MONOGRAPH FINAL part347 0to7 Inc ALLANTOIN .055 g/10g 43319-040_eb9c4e46-c7c8-4f0e-bb3f-b004399d0aa5 43319-040 HUMAN OTC DRUG GOONGSECRET HANDS CLEAN ALCOHOL GEL TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E 0to7 Inc ALCOHOL 46.5 mL/75mL 43319-050_896233e7-0882-4b17-91e0-c1b4c41850c4 43319-050 HUMAN OTC DRUG GOONG SECRET MILD SUN SPF25 PA PLUS PLUS Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 0to7 Inc TITANIUM DIOXIDE; ZINC OXIDE 1.98; 2.82 mg/60mL; mg/60mL 43319-060_865d3db4-dce2-4018-8bba-cb1e0b88e7d1 43319-060 HUMAN OTC DRUG GOONG SECRET CALMING BATH Allantoin POWDER TOPICAL 20130201 OTC MONOGRAPH FINAL part347 0to7 Inc ALLANTOIN .44 mg/80mL 43319-070_6b05da48-f723-4f72-94ed-d264e904ceaf 43319-070 HUMAN OTC DRUG Goongsecret Mild Sun SPF25 PA PLUS PLUS Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 0to7 Inc TITANIUM DIOXIDE; ZINC OXIDE 1.98; 2.82 mg/60mL; mg/60mL 43319-080_e71bffd4-d907-47db-900b-dceb8a463986 43319-080 HUMAN OTC DRUG Goongsecret Calming Bath Oriental Formula for Babies Sodium Bicarbonate POWDER TOPICAL 20130701 OTC MONOGRAPH FINAL part347 0to7 Inc SODIUM BICARBONATE 165 g/300g 43325-828_ee88367f-6d1a-4e52-8934-2d89323bd519 43325-828 HUMAN OTC DRUG LOreal Professionnel Paris Instant Clear Antidandruff Pyrithione Zinc SHAMPOO TOPICAL 20110303 OTC MONOGRAPH FINAL part358H L'Oreal Productos Capilares PYRITHIONE ZINC 5 mL/500mL 43333-441_01f3ed96-0393-4e40-a2c7-8978462be22e 43333-441 HUMAN OTC DRUG Pumpkin Anti-bacterial foaming Hand Wash Benzethonium Chloride LIQUID TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL 43333-442_50555de3-f554-469e-a5c7-e27a49b1747c 43333-442 HUMAN OTC DRUG Pear Anti-bacterial foaming Hand Wash Benzethonium Chloride LIQUID TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL 43333-443_9b44d014-860b-4775-8039-3216214e9466 43333-443 HUMAN OTC DRUG Vanilla Bean Anti-bacterial foaming Hand Wash Benzethonium Chloride LIQUID TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL 43333-444_3938a89d-9a83-44fd-8142-732908ff0d30 43333-444 HUMAN OTC DRUG Spice Anti-bacterial foaming Hand Wash Benzethonium Chloride LIQUID TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL 43333-445_ded57d72-ed2b-4676-bae7-da81500b6070 43333-445 HUMAN OTC DRUG Clementine Anti-bacterial foaming Hand Wash Benzethonium Chloride LIQUID TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL 43337-9328_51f1bb6c-50b6-425e-b536-55c8c693f0fb 43337-9328 HUMAN OTC DRUG Stomachin Antacid Magnesium carbonate and Sodium bicarbonate CAPSULE ORAL 20090430 OTC MONOGRAPH NOT FINAL part331 Chang Kuo Chou Pharmaceutical Co. Ltd. MAGNESIUM CARBONATE; SODIUM BICARBONATE 58; 809 mg/g; mg/g 43337-9329_e5c253c0-7968-40b1-87a7-cbbc1075dfd1 43337-9329 HUMAN OTC DRUG Stomachin Antacid Magnesium carbonate and Sodium bicarbonate POWDER ORAL 20090430 OTC MONOGRAPH FINAL part331 Chang Kuo Chou Pharmaceutical Co. Ltd. MAGNESIUM CARBONATE; SODIUM BICARBONATE 58; 809 mg/g; mg/g 43345-002_09559804-a51c-40a6-9c06-43675309e416 43345-002 HUMAN OTC DRUG Preferred Plus Body Powder Menthol POWDER TOPICAL 20101031 OTC MONOGRAPH NOT FINAL part348 Aetna Felt Corp MENTHOL; ZINC OXIDE .17; 1.1 g/100g; g/100g 43345-003_6443448f-36ac-46f1-b12e-c793b6b7017d 43345-003 HUMAN OTC DRUG Aetna Callus Remover Salicylic Acid PLASTER TOPICAL 19951031 OTC MONOGRAPH FINAL part358B Aetna Felt Corp SALICYLIC ACID .4 1/1001 43345-004_627c1a19-6a8b-48ce-839b-1a8e8e4e9e62 43345-004 HUMAN OTC DRUG Aetna Callus Remover Salicylic Acid PLASTER TOPICAL 19951031 OTC MONOGRAPH FINAL part358F Aetna Felt Corp SALICYLIC ACID 40 1/1 43353-031_0291bd29-faa4-4aa9-83f6-7cb28c229413 43353-031 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 Aphena Pharma Solutions - Tennessee, LLC ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-032_159645df-cd6b-46a3-842b-2d50c920a8de 43353-032 HUMAN PRESCRIPTION DRUG Tricor Fenofibrate TABLET ORAL 20041105 NDA NDA021656 Aphena Pharma Solutions - Tennessee, LLC FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 43353-034_6919ba25-ae85-4fdc-b8d7-48ce9b26e3d5 43353-034 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE ORAL 20060327 ANDA ANDA076917 Aphena Pharma Solutions - Tennessee, LLC CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 43353-035_722b7796-becb-4bd0-ad66-ef8a4d7ff7b9 43353-035 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20091221 ANDA ANDA071995 Aphena Pharma Solutions - Tennessee, Inc. PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 43353-049_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-049 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 43353-050_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-050 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 43353-061_e8c9f182-fcbd-49b2-bd85-7a5ff1060ac1 43353-061 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 19961101 NDA NDA018333 Aphena Pharma Solutions - Tennessee, LLC SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 43353-072_5e1836c1-7b36-4ea5-8fa2-87e8d8d6b21f 43353-072 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 Aphena Pharma Solutions - Tennessee, LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 43353-074_c1cede8c-12ef-4678-be73-35f8b16f2fe3 43353-074 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE, GELATIN COATED ORAL 20070102 ANDA ANDA072253 Aphena Pharma Solutions - Tennessee, Inc. OXAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43353-089_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-089 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 43353-090_885cf4de-06f5-4acc-8feb-f61e7642b366 43353-090 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20100312 ANDA ANDA077836 Aphena Pharma Solutions - Tennessee, LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 43353-131_0bedfead-19aa-4149-ba58-4d0f189267b7 43353-131 HUMAN PRESCRIPTION DRUG Dilantin Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 19760827 ANDA ANDA084349 Aphena Pharma Solutions - Tennessee, Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43353-132_8b8d0afd-873e-40cd-95e6-336eb2a4ca45 43353-132 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077316 Aphena Pharma Solutions - Tennessee, LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 43353-133_8b8d0afd-873e-40cd-95e6-336eb2a4ca45 43353-133 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077316 Aphena Pharma Solutions - Tennessee, LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 43353-142_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-142 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 43353-149_800910de-96de-4c4c-8028-221b98c7d164 43353-149 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 43353-156_8b8d0afd-873e-40cd-95e6-336eb2a4ca45 43353-156 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077316 Aphena Pharma Solutions - Tennessee, LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 43353-159_d22cfbf2-c9ef-43fc-b930-6716f9cc45eb 43353-159 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 Aphena Pharma Solutions - Tennessee, LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 43353-160_8b8d0afd-873e-40cd-95e6-336eb2a4ca45 43353-160 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077316 Aphena Pharma Solutions - Tennessee, LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 43353-178_b0d8a6ff-5163-4f29-abcd-8318b92bbef9 43353-178 HUMAN PRESCRIPTION DRUG Prograf Tacrolimus CAPSULE, GELATIN COATED ORAL 19940408 NDA NDA050708 Aphena Pharma Solutions - Tennessee, LLC TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 43353-199_42a6af57-84a5-44dd-a4a0-ec9d5e954a62 43353-199 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 Aphena Pharma Solutions - Tennessee, LLC HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 43353-215_781c4c71-059d-40d0-bcd3-0867dcb550f3 43353-215 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20040818 ANDA ANDA076368 Aphena Pharma Solutions - Tennessee, LLC POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 43353-244_d77d1a4a-a796-461e-8f2a-fa85d3349a86 43353-244 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20100701 ANDA ANDA076447 Aphena Pharma Solutions - Tennessee, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 43353-263_219f8e97-5db0-4cb5-b5cf-74c64142047e 43353-263 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Aphena Pharma Solutions - Tennessee, LLC PREGABALIN 50 mg/1 CV 43353-264_219f8e97-5db0-4cb5-b5cf-74c64142047e 43353-264 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Aphena Pharma Solutions - Tennessee, LLC PREGABALIN 75 mg/1 CV 43353-277_12b95e60-10f9-423f-9838-b2f514637f39 43353-277 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Aphena Pharma Solutions - Tennessee, LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43353-289_0291bd29-faa4-4aa9-83f6-7cb28c229413 43353-289 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 Aphena Pharma Solutions - Tennessee, LLC ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-290_0291bd29-faa4-4aa9-83f6-7cb28c229413 43353-290 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 Aphena Pharma Solutions - Tennessee, LLC ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-303_061f7a95-4302-49fa-8ecf-9f9a55ef0f31 43353-303 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Aphena Pharma Solutions - Tennessee, LLC DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43353-310_ca87b71c-a13f-4675-b686-e8af41f108b4 43353-310 HUMAN PRESCRIPTION DRUG Depakote ER Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20000804 NDA NDA021168 Aphena Pharma Solutions - Tennessee, LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 43353-323_741bda18-742a-4192-b37c-41680ca38343 43353-323 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20080515 NDA NDA021400 APHENA PHARMA SOLUTIONS - TENNESSEE, INC. VARDENAFIL HYDROCHLORIDE 5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 43353-324_175e43e8-c69d-4ddf-9ae9-ef51dba79a01 43353-324 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040409 Aphena Pharma Solutions - Tennessee, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 43353-336_02f805df-1cef-426c-956d-d038b5ff2ff8 43353-336 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 43353-338_d210a49a-4415-4bb1-b333-8027e459711b 43353-338 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20080131 NDA NDA020987 Aphena Pharma Solutions - Tennessee, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 43353-340_f51ea50d-671d-4901-b5c0-e6135df7e54e 43353-340 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43353-344_f51ea50d-671d-4901-b5c0-e6135df7e54e 43353-344 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43353-349_f51ea50d-671d-4901-b5c0-e6135df7e54e 43353-349 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43353-367_e666a290-143d-4b82-8f54-841db9acabe4 43353-367 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 19971031 ANDA ANDA075079 Aphena Pharma Solutions - Tennessee, LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 43353-368_1242512b-c6e2-466f-a829-aed0a76785da 43353-368 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20070125 ANDA ANDA078060 Aphena Pharma Solutions - Tennessee, LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 43353-389_d0243c04-2828-4d38-b95e-b23374e52d27 43353-389 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Aphena Pharma Solutions - Tennessee, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43353-391_d0243c04-2828-4d38-b95e-b23374e52d27 43353-391 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Aphena Pharma Solutions - Tennessee, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43353-393_d0243c04-2828-4d38-b95e-b23374e52d27 43353-393 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Aphena Pharma Solutions - Tennessee, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43353-413_219f8e97-5db0-4cb5-b5cf-74c64142047e 43353-413 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Aphena Pharma Solutions - Tennessee, LLC PREGABALIN 100 mg/1 CV 43353-414_219f8e97-5db0-4cb5-b5cf-74c64142047e 43353-414 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Aphena Pharma Solutions - Tennessee, LLC PREGABALIN 150 mg/1 CV 43353-422_175e43e8-c69d-4ddf-9ae9-ef51dba79a01 43353-422 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040084 Aphena Pharma Solutions - Tennessee, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 43353-436_048d999c-3507-43e8-ac09-b9013ac06e38 43353-436 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Aphena Pharma Solutions - Tennessee, LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 43353-474_c73f3c0c-77c4-4ac3-a233-f987068b94ac 43353-474 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Aphena Pharma Solutions - Tennessee, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-491_6e052f18-f7a6-4e8b-9222-0a12572960b6 43353-491 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 43353-492_6e052f18-f7a6-4e8b-9222-0a12572960b6 43353-492 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 43353-493_6e052f18-f7a6-4e8b-9222-0a12572960b6 43353-493 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 43353-494_6e052f18-f7a6-4e8b-9222-0a12572960b6 43353-494 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 43353-495_f3aa98c4-1227-4097-9c56-b672796d749d 43353-495 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20030701 NDA AUTHORIZED GENERIC NDA007073 Aphena Pharma Solutions - Tennessee, LLC SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 43353-503_d22cfbf2-c9ef-43fc-b930-6716f9cc45eb 43353-503 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Aphena Pharma Solutions - Tennessee, LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 43353-506_8bdbc4d3-bc72-4981-8cc8-92d9b6a0b523 43353-506 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20090810 ANDA ANDA075927 Aphena Pharma Solutions - Tennessee, LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43353-510_0b579053-078d-424a-ba43-56db5dcb90aa 43353-510 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 19930901 ANDA ANDA074260 Aphena Pharma Solutions - Tennessee, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 43353-535_a8065d90-4130-414c-8b4b-17d5855067b8 43353-535 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Aphena Pharma Solutions - Tennessee, LLC MIRTAZAPINE 15 mg/1 43353-536_a8065d90-4130-414c-8b4b-17d5855067b8 43353-536 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Aphena Pharma Solutions - Tennessee, LLC MIRTAZAPINE 30 mg/1 43353-538_83ef2126-1308-4f4c-a917-a360c7e9f3f1 43353-538 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 Aphena Pharma Solutions - Tennessee, LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 43353-544_8065ca49-06d7-4373-81d0-17e4c33a30b5 43353-544 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20080324 ANDA ANDA078902 Aphena Pharma Solutions - Tennessee, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43353-546_83ef2126-1308-4f4c-a917-a360c7e9f3f1 43353-546 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 Aphena Pharma Solutions - Tennessee, LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 43353-547_a83f0491-37ca-4f44-bb12-2c6780831484 43353-547 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090202 ANDA ANDA077567 Aphena Pharma Solutions - Tennessee, LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 43353-554_8065ca49-06d7-4373-81d0-17e4c33a30b5 43353-554 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20080324 ANDA ANDA078902 Aphena Pharma Solutions - Tennessee, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43353-578_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-578 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 43353-579_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-579 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 43353-583_f3ee686a-e28c-4af6-b06d-e90642ab6442 43353-583 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA076862 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43353-584_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-584 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 43353-587_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-587 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 43353-599_c88a9891-341c-436c-a5dc-60cfe656d1ba 43353-599 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970922 ANDA ANDA074587 Aphena Pharma Solutions - Tennessee, LLC VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 43353-600_c88a9891-341c-436c-a5dc-60cfe656d1ba 43353-600 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960325 ANDA ANDA074587 Aphena Pharma Solutions - Tennessee, LLC VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 43353-607_eb043003-31d8-4757-ac93-1bb8960cf7a4 43353-607 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA076008 Aphena Pharma Solutions - Tennessee, LLC BUSPIRONE HYDROCHLORIDE 15 mg/1 43353-609_eb043003-31d8-4757-ac93-1bb8960cf7a4 43353-609 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20020321 ANDA ANDA076008 Aphena Pharma Solutions - Tennessee, LLC BUSPIRONE HYDROCHLORIDE 5 mg/1 43353-610_eb043003-31d8-4757-ac93-1bb8960cf7a4 43353-610 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20020321 ANDA ANDA076008 Aphena Pharma Solutions - Tennessee, LLC BUSPIRONE HYDROCHLORIDE 10 mg/1 43353-614_a8065d90-4130-414c-8b4b-17d5855067b8 43353-614 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Aphena Pharma Solutions - Tennessee, LLC MIRTAZAPINE 45 mg/1 43353-617_e3b4f606-6863-49a5-be7c-48d86b85bdaf 43353-617 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Aphena Pharma Solutions - Tennessee, LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 43353-620_e3b4f606-6863-49a5-be7c-48d86b85bdaf 43353-620 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Aphena Pharma Solutions - Tennessee, LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 43353-633_e3436ec4-da38-4e59-a2cf-e573bb00925a 43353-633 HUMAN PRESCRIPTION DRUG Rocaltrol calcitriol CAPSULE, GELATIN COATED ORAL 20090810 NDA NDA018044 Aphena Pharma Solutions - Tennessee, Inc. CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 43353-635_6843ed60-a1a4-4a20-a079-8cc1ee7af7ce 43353-635 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20020917 ANDA ANDA075907 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43353-637_07597a7f-cb77-473d-8d64-44f8b0154b71 43353-637 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20010802 ANDA ANDA075049 Aphena Pharma Solutions - Tennessee, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43353-643_25ac0c57-97da-401c-b475-0bd41cc83673 43353-643 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 43353-647_094bc311-4e4d-4a6e-9f7b-6015e38af182 43353-647 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 Aphena Pharma Solutions - Tennessee, LLC DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 43353-648_094bc311-4e4d-4a6e-9f7b-6015e38af182 43353-648 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 Aphena Pharma Solutions - Tennessee, LLC DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 43353-652_79266f41-f728-4daa-9c57-b2a5f3881e17 43353-652 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072192 Aphena Pharma Solutions - Tennessee, LLC TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 43353-653_79266f41-f728-4daa-9c57-b2a5f3881e17 43353-653 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072193 Aphena Pharma Solutions - Tennessee, LLC TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 43353-656_2a0c2fc7-a26a-4b44-9383-d702cb159a21 43353-656 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19840501 NDA AUTHORIZED GENERIC NDA017532 Aphena Pharma Solutions - Tennessee, LLC GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 43353-657_d23b71f4-876d-4774-8b8c-3eb0303b2dbd 43353-657 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 Aphena Pharma Solutions - Tennessee, Inc. PREDNISONE 5 mg/1 43353-659_2a0c2fc7-a26a-4b44-9383-d702cb159a21 43353-659 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19840501 NDA AUTHORIZED GENERIC NDA017532 Aphena Pharma Solutions - Tennessee, LLC GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 43353-662_25ac0c57-97da-401c-b475-0bd41cc83673 43353-662 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 43353-663_f6a44bf9-c610-4be8-a289-2bbbe103b9c8 43353-663 HUMAN PRESCRIPTION DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078801 Aphena Pharma Solutions - Tennessee, LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 43353-675_219f8e97-5db0-4cb5-b5cf-74c64142047e 43353-675 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Aphena Pharma Solutions - Tennessee, LLC PREGABALIN 200 mg/1 CV 43353-677_8bdbc4d3-bc72-4981-8cc8-92d9b6a0b523 43353-677 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040401 ANDA ANDA076494 Aphena Pharma Solutions - Tennessee, LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43353-681_8e145279-0997-4800-901d-6f96059c681c 43353-681 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20100604 ANDA ANDA040756 Aphena Pharma Solutions - Tennessee, LLC FOLIC ACID 1 mg/1 43353-684_b5d4081c-5d64-4deb-abb8-955faa99f251 43353-684 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Aphena Pharma Solutions - Tennessee, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 43353-686_2b1eb024-67ec-47d5-a360-b2194ce79f33 43353-686 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 19960216 ANDA ANDA074069 Aphena Pharma Solutions - Tennessee, LLC AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 43353-687_950b1a7a-07f6-4741-9846-0e2f7e798e3e 43353-687 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Aphena Pharma Solutions - Tennessee, Inc. ESTROGENS, CONJUGATED .3 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 43353-688_950b1a7a-07f6-4741-9846-0e2f7e798e3e 43353-688 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Aphena Pharma Solutions - Tennessee, Inc. ESTROGENS, CONJUGATED .625 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 43353-689_a9d8d871-3b80-47a6-9029-1e9445bcdf77 43353-689 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20100804 ANDA ANDA090027 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43353-690_a9d8d871-3b80-47a6-9029-1e9445bcdf77 43353-690 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20100804 ANDA ANDA090027 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43353-691_b5d4081c-5d64-4deb-abb8-955faa99f251 43353-691 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Aphena Pharma Solutions - Tennessee, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 43353-693_ddc19c82-dad2-4b79-abda-4730858afea8 43353-693 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065211 Aphena Pharma Solutions - Tennessee, LLC AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 43353-701_018fea8f-a408-468e-b2c5-c203cd8ef235 43353-701 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070218 Aphena Pharma Solutions - Tennessee, LLC PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43353-706_018fea8f-a408-468e-b2c5-c203cd8ef235 43353-706 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070219 Aphena Pharma Solutions - Tennessee, LLC PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43353-709_63578037-37d7-4aff-8c75-da3338940c06 43353-709 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Aphena Pharma Solutions - Tennessee, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43353-710_63578037-37d7-4aff-8c75-da3338940c06 43353-710 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Aphena Pharma Solutions - Tennessee, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43353-711_7d55fc67-1183-48fe-b6f6-a9cbc1df0d25 43353-711 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20121025 ANDA ANDA070920 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43353-721_175e43e8-c69d-4ddf-9ae9-ef51dba79a01 43353-721 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040405 Aphena Pharma Solutions - Tennessee, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 43353-724_6ff594b7-180e-4f63-a0e4-aa9e41205051 43353-724 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 19840702 20150930 NDA NDA020405 Aphena Pharma Solutions - Tennessee, LLC DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 43353-725_6ff594b7-180e-4f63-a0e4-aa9e41205051 43353-725 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 19840914 20150930 NDA NDA020405 Aphena Pharma Solutions - Tennessee, LLC DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 43353-727_8f487e7b-4fbe-4c56-b86f-4cfcda789e09 43353-727 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101206 NDA AUTHORIZED GENERIC NDA021774 Aphena Pharma Solutions - Tennessee, LLC ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 43353-731_63578037-37d7-4aff-8c75-da3338940c06 43353-731 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Aphena Pharma Solutions - Tennessee, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43353-732_d8e9d4e0-1fe8-45df-96ac-b6328eb3301d 43353-732 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070601 ANDA ANDA040702 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43353-733_d8e9d4e0-1fe8-45df-96ac-b6328eb3301d 43353-733 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070601 ANDA ANDA040702 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43353-734_d22cfbf2-c9ef-43fc-b930-6716f9cc45eb 43353-734 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 Aphena Pharma Solutions - Tennessee, LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 43353-735_0f90e61a-246f-4162-929d-001bec7e31d4 43353-735 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100719 ANDA ANDA077455 Aphena Pharma Solutions - Tennessee, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 43353-736_c2c53be9-ea0f-4dc5-a61f-2b6f8904d842 43353-736 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 Aphena Pharma Solutions - Tennessee, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 43353-737_3f914177-d57c-4f45-9cf3-4b98f8354ef8 43353-737 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 Aphena Pharma Solutions - Tennessee, LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 43353-741_95bf61f7-6238-4b01-b70e-df731b5f642b 43353-741 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20110422 NDA NDA021400 APHENA PHARMA SOLUTIONS - TENNESSEE, INC. VARDENAFIL HYDROCHLORIDE 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 43353-742_959e4ed8-d633-4f2c-a52d-775c3ef577df 43353-742 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Aphena Pharma Solutions - Tennessee, LLC HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 43353-744_95bf61f7-6238-4b01-b70e-df731b5f642b 43353-744 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20110422 NDA NDA021400 APHENA PHARMA SOLUTIONS - TENNESSEE, INC. VARDENAFIL HYDROCHLORIDE 5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 43353-747_2656c2f1-2696-4c6a-9f2f-8e738b86cceb 43353-747 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 Aphena Pharma Solutions - Tennessee, LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 43353-748_95bf61f7-6238-4b01-b70e-df731b5f642b 43353-748 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20110422 NDA NDA021400 APHENA PHARMA SOLUTIONS - TENNESSEE, INC. VARDENAFIL HYDROCHLORIDE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 43353-749_3402aba2-a410-42e5-8981-b25e27c07a49 43353-749 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980312 ANDA ANDA075074 Aphena Pharma Solutions - Tennessee, LLC ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43353-750_5d4b75d6-4cf4-461f-9d36-2d6eab6cccc1 43353-750 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120723 ANDA ANDA201071 Aphena Pharma Solutions - Tennessee, LLC NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 43353-752_3402aba2-a410-42e5-8981-b25e27c07a49 43353-752 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980311 ANDA ANDA075074 Aphena Pharma Solutions - Tennessee, LLC ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43353-753_3402aba2-a410-42e5-8981-b25e27c07a49 43353-753 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980405 ANDA ANDA075078 Aphena Pharma Solutions - Tennessee, LLC ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43353-754_9139290e-82d1-40ea-afbe-4fd7be934799 43353-754 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 Aphena Pharma Solutions - Tennessee, LLC RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 43353-755_9139290e-82d1-40ea-afbe-4fd7be934799 43353-755 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 Aphena Pharma Solutions - Tennessee, LLC RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 43353-756_959e4ed8-d633-4f2c-a52d-775c3ef577df 43353-756 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Aphena Pharma Solutions - Tennessee, LLC HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 43353-757_9139290e-82d1-40ea-afbe-4fd7be934799 43353-757 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 Aphena Pharma Solutions - Tennessee, LLC RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 43353-763_74ee4693-b945-4dda-9ce5-ea72e4568f34 43353-763 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20020606 ANDA ANDA075991 Aphena Pharma Solutions - Tennessee, LLC LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-764_ef12ceed-7534-472e-a8a8-08cafeada087 43353-764 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Aphena Pharma Solutions - Tennessee, LLC SILDENAFIL CITRATE 25 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 43353-766_9139290e-82d1-40ea-afbe-4fd7be934799 43353-766 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 Aphena Pharma Solutions - Tennessee, LLC RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 43353-767_935e87ee-39e2-46b7-94c1-9d3b88057ff7 43353-767 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Aphena Pharma Solutions - Tennessee, LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 43353-768_32c9ba10-d55e-4ed1-9ae8-6621580495df 43353-768 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111017 ANDA ANDA078034 Aphena Pharma Solutions - Tennessee, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-769_36b19b28-8577-4be5-bab3-b8f32b9f6a33 43353-769 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090301 ANDA ANDA078503 Aphena Pharma Solutions - Tennessee, Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 43353-771_c132877c-8560-4c40-aa6a-d53da089ff5a 43353-771 HUMAN PRESCRIPTION DRUG SALSALATE SALSALATE TABLET ORAL 20110522 UNAPPROVED DRUG OTHER Aphena Pharma Solutions - Tennessee, Inc. SALSALATE 750 mg/1 43353-772_23a800db-9bfe-464f-9fc2-5090f2fa6840 43353-772 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20110401 ANDA ANDA078012 Aphena Pharma Solutions - Tennessee, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 43353-773_32c9ba10-d55e-4ed1-9ae8-6621580495df 43353-773 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111017 ANDA ANDA078034 Aphena Pharma Solutions - Tennessee, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-779_048d999c-3507-43e8-ac09-b9013ac06e38 43353-779 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Aphena Pharma Solutions - Tennessee, LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 43353-782_5ef126e4-1e7f-4526-8052-148d3ff10a56 43353-782 HUMAN PRESCRIPTION DRUG Afeditab CR Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021101 ANDA ANDA075659 Aphena Pharma Solutions - Tennessee, LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 43353-783_32c4f44c-dd59-4b03-b271-6e51d20dbf75 43353-783 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Aphena Pharma Solutions - Tennessee, LLC DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43353-784_fd5924d8-e3f8-4164-81d6-2a5aea0dd202 43353-784 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 Aphena Pharma Solutions - Tennessee, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43353-785_f8e096c7-a9df-4f0a-8b74-a8d85c8b257a 43353-785 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 43353-786_f8e096c7-a9df-4f0a-8b74-a8d85c8b257a 43353-786 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 43353-787_01211049-3b2e-4d9c-a26b-ff2b30bcb118 43353-787 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline TABLET, FILM COATED ORAL 20120203 ANDA ANDA078626 Aphena Pharma Solutions - Tennessee, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43353-788_f8e096c7-a9df-4f0a-8b74-a8d85c8b257a 43353-788 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 43353-790_7c37fbd5-1883-41e4-ac9b-cc4b5ca3efd0 43353-790 HUMAN PRESCRIPTION DRUG K-Tab Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19800609 NDA NDA018279 Aphena Pharma Solutions - Tennessee, LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 43353-792_5ef126e4-1e7f-4526-8052-148d3ff10a56 43353-792 HUMAN PRESCRIPTION DRUG Afeditab CR Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021101 ANDA ANDA075128 Aphena Pharma Solutions - Tennessee, LLC NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 43353-794_fa4f2400-1f0e-402b-a511-b791ad6ab78e 43353-794 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET ORAL 20120229 ANDA ANDA040133 Aphena Pharma Solutions - Tennessee, LLC HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 43353-795_f3ee686a-e28c-4af6-b06d-e90642ab6442 43353-795 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100415 ANDA ANDA077298 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43353-796_f64c95f3-04d8-4fae-98eb-7c794c449480 43353-796 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040742 Aphena Pharma Solutions - Tennessee, LLC BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 43353-797_37a31bbb-6d44-4d2b-a8ed-32dc6f20a3e2 43353-797 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 Aphena Pharma Solutions - Tennessee, LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 43353-798_5050be4b-d47d-4725-9199-caefcc088f11 43353-798 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20120507 ANDA ANDA079098 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43353-799_12b95e60-10f9-423f-9838-b2f514637f39 43353-799 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Aphena Pharma Solutions - Tennessee, LLC CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43353-800_3e3953cf-b2ac-42a5-a8a4-e33e0e4f29ad 43353-800 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43353-802_5050be4b-d47d-4725-9199-caefcc088f11 43353-802 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20120507 ANDA ANDA079098 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43353-808_24332066-8223-4d5c-8957-5c69a287249e 43353-808 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA071250 Aphena Pharma Solutions - Tennessee, LLC METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 43353-809_0693bc9f-ad99-415a-816e-5f3e0e33e682 43353-809 HUMAN PRESCRIPTION DRUG SERTRALINE Sertraline TABLET, FILM COATED ORAL 20120820 ANDA ANDA077397 Aphena Pharma Solutions - Tennessee, LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43353-811_67000fc3-2523-4e96-9b11-3ff6a6638afe 43353-811 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20120626 ANDA ANDA077880 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43353-812_0693bc9f-ad99-415a-816e-5f3e0e33e682 43353-812 HUMAN PRESCRIPTION DRUG SERTRALINE Sertraline TABLET, FILM COATED ORAL 20120820 ANDA ANDA077397 Aphena Pharma Solutions - Tennessee, LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43353-813_59a4aa04-8122-4125-95ef-b30e33c375ed 43353-813 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090749 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 43353-814_59a4aa04-8122-4125-95ef-b30e33c375ed 43353-814 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090120 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 43353-815_af997b83-9a05-4373-83af-99c2745d0f73 43353-815 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-817_0693bc9f-ad99-415a-816e-5f3e0e33e682 43353-817 HUMAN PRESCRIPTION DRUG SERTRALINE Sertraline TABLET, FILM COATED ORAL 20120820 ANDA ANDA077397 Aphena Pharma Solutions - Tennessee, LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43353-818_59a4aa04-8122-4125-95ef-b30e33c375ed 43353-818 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090120 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 43353-819_71eaa797-a9d9-4eb6-be98-68fc6af213cc 43353-819 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA080356 Aphena Pharma Solutions - Tennessee, LLC PREDNISONE 5 mg/1 43353-820_32c4f44c-dd59-4b03-b271-6e51d20dbf75 43353-820 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Aphena Pharma Solutions - Tennessee, LLC DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43353-821_af997b83-9a05-4373-83af-99c2745d0f73 43353-821 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-824_6ea4aa04-8d99-4cdb-8d01-8a80ec995b70 43353-824 HUMAN PRESCRIPTION DRUG FOLIC ACID FOLIC ACID TABLET ORAL 20100406 ANDA ANDA090035 Aphena Pharma Solutions - Tennessee, LLC FOLIC ACID 1 mg/1 43353-826_e3653acb-0b12-40b4-b693-9972c46af386 43353-826 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-827_e3653acb-0b12-40b4-b693-9972c46af386 43353-827 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-828_9e948241-a8c1-46e2-98c8-9c10893556b0 43353-828 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20100315 ANDA ANDA040865 Aphena Pharma Solutions - Tennessee, LLC ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 43353-829_401ad0d0-fa30-47a8-9314-9a07a05bbabc 43353-829 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20090123 ANDA ANDA075410 Aphena Pharma Solutions - Tennessee, LLC OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 43353-830_cba7fa75-7b6b-4add-8a60-7dcb8557d9b5 43353-830 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19930330 ANDA ANDA073475 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43353-831_adec9b98-1867-41a0-9288-3185c095a6fc 43353-831 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20120810 ANDA ANDA076594 Aphena Pharma Solutions - Tennessee, LLC MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 43353-832_52bbd393-493f-4a64-92b3-dbb320607c1a 43353-832 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aphena Pharma Solutions - Tennessee, LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 43353-833_dac66f7f-c5e7-4781-a1d1-540604e87d76 43353-833 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20041116 ANDA ANDA074056 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43353-836_5d4b75d6-4cf4-461f-9d36-2d6eab6cccc1 43353-836 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120723 ANDA ANDA201071 Aphena Pharma Solutions - Tennessee, LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 43353-837_52bbd393-493f-4a64-92b3-dbb320607c1a 43353-837 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aphena Pharma Solutions - Tennessee, LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 43353-838_52bbd393-493f-4a64-92b3-dbb320607c1a 43353-838 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aphena Pharma Solutions - Tennessee, LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 43353-839_f0b71958-717d-4b8d-93ef-3f0f5f1d0c60 43353-839 HUMAN PRESCRIPTION DRUG Probenecid Probenecid TABLET, FILM COATED ORAL 19760729 ANDA ANDA080966 Aphena Pharma Solutions - Tennessee, LLC PROBENECID 500 mg/1 43353-840_219f8e97-5db0-4cb5-b5cf-74c64142047e 43353-840 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Aphena Pharma Solutions - Tennessee, LLC PREGABALIN 300 mg/1 CV 43353-842_67000fc3-2523-4e96-9b11-3ff6a6638afe 43353-842 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20120626 ANDA ANDA077880 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43353-847_f8e096c7-a9df-4f0a-8b74-a8d85c8b257a 43353-847 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 43353-848_bd5ca3e8-e294-46b9-94b4-3a66309a40b9 43353-848 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Aphena Pharma Solutions - Tennessee, LLC ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] 43353-849_bd5ca3e8-e294-46b9-94b4-3a66309a40b9 43353-849 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Aphena Pharma Solutions - Tennessee, LLC ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] 43353-850_bd5ca3e8-e294-46b9-94b4-3a66309a40b9 43353-850 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Aphena Pharma Solutions - Tennessee, LLC ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] 43353-852_f8e096c7-a9df-4f0a-8b74-a8d85c8b257a 43353-852 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 43353-854_31cb7052-4226-4ab2-96c2-8a7fe4714d82 43353-854 HUMAN PRESCRIPTION DRUG Colcrys Colchicine TABLET, FILM COATED ORAL 20090901 NDA NDA022352 Aphena Pharma Solutions - Tennessee, LLC COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 43353-856_68513fbe-c3f6-42f4-8358-589aad365109 43353-856 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aphena Pharma Solutions - Tennessee, LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-857_6cb64ba8-98f2-4abf-b58f-e721f756eca6 43353-857 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Aphena Pharma Solutions - Tennessee, LLC TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 43353-858_68513fbe-c3f6-42f4-8358-589aad365109 43353-858 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aphena Pharma Solutions - Tennessee, LLC SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-860_68513fbe-c3f6-42f4-8358-589aad365109 43353-860 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aphena Pharma Solutions - Tennessee, LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-861_68513fbe-c3f6-42f4-8358-589aad365109 43353-861 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aphena Pharma Solutions - Tennessee, LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-862_c59d70ed-784f-43aa-80c6-d1e252696641 43353-862 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43353-863_c59d70ed-784f-43aa-80c6-d1e252696641 43353-863 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43353-864_c59d70ed-784f-43aa-80c6-d1e252696641 43353-864 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43353-865_43634dd1-d97c-4fb3-a9bc-b8576f449655 43353-865 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20130618 ANDA ANDA076262 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43353-866_43634dd1-d97c-4fb3-a9bc-b8576f449655 43353-866 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20130618 ANDA ANDA076262 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43353-867_43634dd1-d97c-4fb3-a9bc-b8576f449655 43353-867 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20130618 ANDA ANDA076262 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43353-868_b1e524e2-cf67-4344-9a06-3e82920af608 43353-868 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20130517 ANDA ANDA072575 Aphena Pharma Solutions - Tennessee, LLC PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 43353-869_f73c56b6-209d-4f7e-97a6-7bc119910fbb 43353-869 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130612 ANDA ANDA090174 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43353-870_6aaf33c1-90ec-45ad-87fe-603d794a8a0e 43353-870 HUMAN PRESCRIPTION DRUG Fosinopril sodium Fosinopril sodium TABLET ORAL 20050621 ANDA ANDA077222 Aphena Pharma Solutions - Tennessee, LLC FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 43353-872_e9ca1ee7-40fa-4579-87dc-3077b00d9718 43353-872 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin TABLET, FILM COATED ORAL 20121102 ANDA ANDA202764 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43353-874_52bbd393-493f-4a64-92b3-dbb320607c1a 43353-874 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aphena Pharma Solutions - Tennessee, LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 43353-875_68513fbe-c3f6-42f4-8358-589aad365109 43353-875 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aphena Pharma Solutions - Tennessee, LLC SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-876_219f8e97-5db0-4cb5-b5cf-74c64142047e 43353-876 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Aphena Pharma Solutions - Tennessee, LLC PREGABALIN 225 mg/1 CV 43353-879_84b17471-807e-4af9-b4ad-a20fe327860f 43353-879 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120810 ANDA ANDA201522 Aphena Pharma Solutions - Tennessee, LLC MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 43353-882_f73c56b6-209d-4f7e-97a6-7bc119910fbb 43353-882 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130612 ANDA ANDA090174 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43353-883_5817ec48-bede-499e-ba77-d094e3bdd1ae 43353-883 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Aphena Pharma Solutions - Tennessee, LLC VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 43353-885_67000fc3-2523-4e96-9b11-3ff6a6638afe 43353-885 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20120626 ANDA ANDA077880 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43353-888_5daab746-e686-48fc-a47d-ba12ec36b88f 43353-888 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Aphena Pharma Solutions - Tennessee, LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 43353-889_5daab746-e686-48fc-a47d-ba12ec36b88f 43353-889 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Aphena Pharma Solutions - Tennessee, LLC DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 43353-892_e3653acb-0b12-40b4-b693-9972c46af386 43353-892 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-894_d7df9cc9-2bfc-458a-8a60-aecb3ee7ea6f 43353-894 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20140203 ANDA ANDA075965 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43353-895_2a0c2fc7-a26a-4b44-9383-d702cb159a21 43353-895 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19840501 NDA AUTHORIZED GENERIC NDA017532 Aphena Pharma Solutions - Tennessee, LLC GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 43353-900_d7fb489a-3230-42da-9d88-236a95d8ad1a 43353-900 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 Aphena Pharma Solutions - Tennessee, LLC BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 43353-903_5daab746-e686-48fc-a47d-ba12ec36b88f 43353-903 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Aphena Pharma Solutions - Tennessee, LLC DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 43353-904_af997b83-9a05-4373-83af-99c2745d0f73 43353-904 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-906_5daab746-e686-48fc-a47d-ba12ec36b88f 43353-906 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Aphena Pharma Solutions - Tennessee, LLC DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 43353-907_5daab746-e686-48fc-a47d-ba12ec36b88f 43353-907 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Aphena Pharma Solutions - Tennessee, LLC DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 43353-908_744f01da-309f-4cf6-b74e-27648a32a573 43353-908 HUMAN PRESCRIPTION DRUG Precose Acarbose TABLET ORAL 20080130 NDA NDA020482 Aphena Pharma Solutions - Tennessee, LLC ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 43353-911_8992cc1b-9f28-40a5-8c95-06acb3b851b6 43353-911 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Aphena Pharma Solutions - Tennessee, LLC ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 43353-912_8992cc1b-9f28-40a5-8c95-06acb3b851b6 43353-912 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Aphena Pharma Solutions - Tennessee, LLC ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 43353-913_f64c95f3-04d8-4fae-98eb-7c794c449480 43353-913 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040738 Aphena Pharma Solutions - Tennessee, LLC BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 43353-914_9abef36b-8516-48fe-9420-d663cd6d9726 43353-914 HUMAN PRESCRIPTION DRUG Tizanidine tizanidine TABLET ORAL 20030506 ANDA ANDA076354 Aphena Pharma Solutions - Tennessee, LLC TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 43353-917_30b5ea6e-6e11-4381-affc-45db25bdf092 43353-917 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Aphena Pharma Solutions - Tennessee, LLC ISOSORBIDE MONONITRATE 120 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 43353-918_3402aba2-a410-42e5-8981-b25e27c07a49 43353-918 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980405 ANDA ANDA075078 Aphena Pharma Solutions - Tennessee, LLC ETODOLAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 43353-919_959e4ed8-d633-4f2c-a52d-775c3ef577df 43353-919 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Aphena Pharma Solutions - Tennessee, LLC HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 43353-920_8992cc1b-9f28-40a5-8c95-06acb3b851b6 43353-920 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Aphena Pharma Solutions - Tennessee, LLC ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 43353-922_238888fe-9e07-428e-b95e-4fd980ec8f8f 43353-922 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 19810226 ANDA ANDA086831 Aphena Pharma Solutions - Tennessee, LLC CHLORTHALIDONE 50 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 43353-923_41ea6c31-c3a7-411b-aae1-2cf7e9088f67 43353-923 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19860710 ANDA ANDA062677 Aphena Pharma Solutions - Tennessee, LLC DOXYCYCLINE HYCLATE 100 mg/1 43353-924_cbcaf591-b314-4aaa-af60-5da3876e25ac 43353-924 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20090801 ANDA ANDA077859 Aphena Pharma Solutions - Tennessee, LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 43353-925_d1e9e94d-f917-48b2-88d5-9f9551b4cd49 43353-925 HUMAN PRESCRIPTION DRUG modafinil modafinil TABLET ORAL 20120329 NDA AUTHORIZED GENERIC NDA020717 Aphena Pharma Solutions - Tennessee, LLC MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 43353-926_377b3679-29e3-4a57-baf1-9761ea57eefc 43353-926 HUMAN PRESCRIPTION DRUG HYZAAR losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43353-927_6363687c-dcff-451f-8a81-d9f04e79f9ad 43353-927 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20060425 ANDA ANDA076056 Aphena Pharma Solutions - Tennessee, LLC PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43353-933_32129338-bb18-4c4b-80a2-57ee2631feeb 43353-933 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 20120921 ANDA ANDA077309 Aphena Pharma Solutions - Tennessee, LLC ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 43353-936_d7df9cc9-2bfc-458a-8a60-aecb3ee7ea6f 43353-936 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20140203 ANDA ANDA075965 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43353-942_47c039de-c6d8-40fc-bae3-7a45eb9da57b 43353-942 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43353-943_47c039de-c6d8-40fc-bae3-7a45eb9da57b 43353-943 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43353-944_47c039de-c6d8-40fc-bae3-7a45eb9da57b 43353-944 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43353-946_9abef36b-8516-48fe-9420-d663cd6d9726 43353-946 HUMAN PRESCRIPTION DRUG Tizanidine tizanidine TABLET ORAL 20030506 ANDA ANDA076354 Aphena Pharma Solutions - Tennessee, LLC TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 43353-947_de10cd2f-4523-4c70-96f3-9d238c6d74c7 43353-947 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19870218 ANDA ANDA071293 Aphena Pharma Solutions - Tennessee, LLC AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 43374-575_bff2fb8b-0a6b-4aee-af5a-c88eabb55422 43374-575 HUMAN OTC DRUG Quik San BENZETHONIUM CHLORIDE LIQUID TOPICAL 20090831 OTC MONOGRAPH NOT FINAL part333 Delta Foremost Chemical Corporation BENZETHONIUM CHLORIDE 2 mg/mL 43376-104_5c36c308-b26d-492d-b923-80f600727c8c 43376-104 HUMAN PRESCRIPTION DRUG Sumavel DosePro sumatriptan INJECTION SUBCUTANEOUS 20131204 NDA NDA022239 Zogenix, Inc. SUMATRIPTAN SUCCINATE 4 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 43376-106_5c36c308-b26d-492d-b923-80f600727c8c 43376-106 HUMAN PRESCRIPTION DRUG Sumavel DosePro sumatriptan INJECTION SUBCUTANEOUS 20090715 NDA NDA022239 Zogenix, Inc. SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 43376-210_78f08950-950a-49a4-bd99-3f23befa4d01 43376-210 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 10 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 43376-215_78f08950-950a-49a4-bd99-3f23befa4d01 43376-215 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 15 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 43376-220_78f08950-950a-49a4-bd99-3f23befa4d01 43376-220 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 20 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 43376-230_78f08950-950a-49a4-bd99-3f23befa4d01 43376-230 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 30 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 43376-240_78f08950-950a-49a4-bd99-3f23befa4d01 43376-240 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 40 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 43376-250_78f08950-950a-49a4-bd99-3f23befa4d01 43376-250 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 43378-100_07b96821-a0ec-4b87-8eea-bd21464f83b2 43378-100 HUMAN OTC DRUG Zodryl AC 25 Chlorpheniramine Maleate and Codeine Phosphate SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE .999; 3 mg/3mL; mg/3mL CV 43378-101_ba259ded-5663-41c0-a6d4-384ed958131e 43378-101 HUMAN OTC DRUG Zodryl AC 30 Chlorpheniramine Maleate and Codeine Phosphate SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 1.001; 3.5 mg/3.5mL; mg/3.5mL CV 43378-103_acbdfd6d-65fb-4bbf-8cca-4642857fc09d 43378-103 HUMAN OTC DRUG Zodryl AC 40 Chlorpheniramine Maleate and Codeine Phosphate SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE .999; 4.5 mg/4.5mL; mg/4.5mL CV 43378-104_332c8ac7-01ed-4ec5-abb9-bdb98eefd043 43378-104 HUMAN OTC DRUG Zodryl AC 50 Chlorpheniramine Maleate and Codeine Phosphate SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 2; 5 mg/5mL; mg/5mL CV 43378-105_80883522-1b50-4ba4-8375-787feaa941cb 43378-105 HUMAN OTC DRUG Zodryl AC 60 Chlorpheniramine Maleate and Codeine Phosphate SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 1.995; 7.5 mg/7.5mL; mg/7.5mL CV 43378-106_1600c314-ebc0-4ac3-9d8b-bc4d5073857b 43378-106 HUMAN OTC DRUG Zodryl AC 80 Chlorpheniramine Maleate and Codeine Phosphate SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 2; 10 mg/10mL; mg/10mL CV 43378-120_fa37ced4-619b-4514-9d32-ae50a6572427 43378-120 HUMAN OTC DRUG Zodryl DEC 25 codeine phosphate, guaifenesin and pseudoephedrine hydrochloride SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 3; 60; 15 mg/3mL; mg/3mL; mg/3mL CV 43378-121_e81702b3-1466-41fc-862b-f387a1fe39e5 43378-121 HUMAN OTC DRUG Zodryl DEC 30 codeine phosphate, guaifenesin and pseudoephedrine hydrochloride SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 3.5; 70; 15.001 mg/3.5mL; mg/3.5mL; mg/3.5mL CV 43378-123_b51a9a1b-ddbe-47fc-bd22-d9e078dccb9b 43378-123 HUMAN OTC DRUG Zodryl DEC 40 codeine phosphate, guaifenesin and pseudoephedrine hydrochloride SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 4.5; 90; 14.998 mg/4.5mL; mg/4.5mL; mg/4.5mL CV 43378-124_5ace705f-df68-4517-b65a-06c468111906 43378-124 HUMAN OTC DRUG Zodryl DEC 50 codeine phosphate, guaifenesin and pseudoephedrine hydrochloride SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 100; 30 mg/5mL; mg/5mL; mg/5mL CV 43378-125_980d54c0-8941-4180-8952-9ae39c5130b3 43378-125 HUMAN OTC DRUG Zodryl DEC 60 codeine phosphate, guaifenesin and pseudoephedrine hydrochloride SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 7.5; 150; 30 mg/7.5mL; mg/7.5mL; mg/7.5mL CV 43378-126_5e3f17d1-bcb6-4d05-bdd7-59012af8cf4b 43378-126 HUMAN OTC DRUG Zodryl DEC 80 codeine phosphate, guaifenesin and pseudoephedrine hydrochloride SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE 10; 200; 30 mg/10mL; mg/10mL; mg/10mL CV 43386-050_9405ab30-a280-4968-a72f-ec9e25b293de 43386-050 HUMAN PRESCRIPTION DRUG GaviLyte - N Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate POWDER, FOR SOLUTION ORAL 20090528 ANDA ANDA090019 GAVIS Pharmaceuticals, LLC POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420; 1.48; 5.72; 11.2 g/438.4g; g/438.4g; g/438.4g; g/438.4g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 43386-060_22ec8294-020f-44f0-a002-d7221dfbe991 43386-060 HUMAN PRESCRIPTION DRUG GaviLyte - C TM Polyethylene Glycol-3350 and Electrolytes with Flavor Pack POWDER, FOR SOLUTION ORAL 20090601 ANDA ANDA090186 GAVIS Pharmaceuticals, LLC POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 240; 2.98; 6.72; 5.84; 22.72 g/278.26g; g/278.26g; g/278.26g; g/278.26g; g/278.26g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 43386-090_f252aead-84d7-4cb3-b968-a1bb351845ec 43386-090 HUMAN PRESCRIPTION DRUG GaviLyte G TM Polyethylene Glycol-3350 and Electrolytes POWDER, FOR SOLUTION ORAL 20090601 ANDA ANDA090231 GAVIS Pharmaceuticals, LLC POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 236; 2.97; 6.74; 5.86; 22.74 g/274.31g; g/274.31g; g/274.31g; g/274.31g; g/274.31g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 43386-118_3fd95736-da4d-4c37-a888-d39aba107460 43386-118 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide TABLET ORAL 20140923 ANDA ANDA091528 Gavis Pharmaceuticals, LLC HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 43386-140_2a36cc17-60c3-48c8-941b-5cc1dcacc8f0 43386-140 HUMAN PRESCRIPTION DRUG Methylergonovine Maleate Methylergonovine Maleate TABLET ORAL 20110615 ANDA ANDA091577 GAVIS Pharmaceuticals, LLC METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 43386-160_cf380ce8-c131-407c-8fc5-ccddfec5495b 43386-160 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 GAVIS Pharmaceuticals, LLC MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 43386-161_cf380ce8-c131-407c-8fc5-ccddfec5495b 43386-161 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 GAVIS Pharmaceuticals, LLC MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 43386-312_7e532234-57ba-4dd0-82e1-369405584eae 43386-312 HUMAN OTC DRUG GAVILAX Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091009 ANDA ANDA091077 GAVIS Pharmaceuticals, LLC POLYETHYLENE GLYCOL 3350 17 g/17g 43386-330_117abb1a-8268-47a2-b3d2-acc813a7defb 43386-330 HUMAN PRESCRIPTION DRUG Trimethoprim trimethoprim TABLET ORAL 20110624 ANDA ANDA091437 GAVIS Pharmaceuticals, LLC TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 43386-360_170f3fd1-7e6c-4705-8def-f9a8300cf9e2 43386-360 HUMAN PRESCRIPTION DRUG Phenelzine Sulfate Phenelzine Sulfate TABLET ORAL 20101214 ANDA ANDA200181 GAVIS Pharmaceuticals, LLC PHENELZINE SULFATE 15 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] 43386-440_2be1748e-7281-43e8-b109-95c16c69985c 43386-440 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE ORAL 20090811 ANDA ANDA072781 GAVIS Pharmaceuticals, LLC NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 43386-480_4ed1b591-ba7e-40a4-be30-6a7cf7261dea 43386-480 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Gavis Pharmaceuticals, LLC ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 43386-500_b86b32a0-e6d8-4a0a-ad13-05dfc093c368 43386-500 HUMAN PRESCRIPTION DRUG Famotidine Famotidine FOR SUSPENSION ORAL 20121217 ANDA ANDA201695 GAVIS Pharmaceuticals, LLC FAMOTIDINE 40 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 43386-510_cd11492c-78f9-465b-a304-a4cad3bd5edd 43386-510 HUMAN PRESCRIPTION DRUG Mesalamine Mesalamine ENEMA RECTAL 20091216 ANDA ANDA019618 GAVIS Pharmaceuticals, LLC MESALAMINE 4 g/60mL Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 43386-530_3264838e-f14a-4b86-a9e4-ba83eb45e5f9 43386-530 HUMAN PRESCRIPTION DRUG Nystatin Nystatin POWDER TOPICAL 20140926 ANDA ANDA065138 Gavis Pharmaceuticals, LLC. NYSTATIN 100000 U/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 43386-550_e6c65d80-f789-4e7a-bfdf-bfa763318edd 43386-550 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET ORAL 20120430 ANDA ANDA202044 Gavis Pharmaceuticals, LLC TINIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 43386-551_e6c65d80-f789-4e7a-bfdf-bfa763318edd 43386-551 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET ORAL 20120430 ANDA ANDA202044 Gavis Pharmaceuticals, LLC TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 43386-620_07b96626-aa19-4ce3-8ef5-c2cbebdb05f6 43386-620 HUMAN PRESCRIPTION DRUG My Way Levonorgestrel TABLET ORAL 20130222 ANDA ANDA202508 GAVIS Pharmaceuticals, LLC. LEVONORGESTREL 1.5 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 43386-622_f0479eb2-a726-47f0-b64a-61370db814b6 43386-622 HUMAN OTC DRUG My Way Levonorgestrel TABLET ORAL 20130215 ANDA ANDA202508 GAVIS Pharmaceuticals, LLC LEVONORGESTREL 1.5 mg/1 43386-660_b09aec67-ee55-467a-9e9f-1a6f1973eb79 43386-660 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE ORAL 20110117 ANDA ANDA076546 GAVIS Pharmaceuticals, LLC TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 43386-670_fc01cb97-4b1c-4f4f-baed-401357b05489 43386-670 HUMAN PRESCRIPTION DRUG Pentazocine Hydrochloride and Acetaminophen Pentazocine Hydrochloride and Acetaminophen TABLET ORAL 20110511 ANDA ANDA076202 GAVIS Pharmaceuticals, LLC ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE 650; 25 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV 43386-680_2b4af9bc-54d0-4367-b2d9-802f8805b99c 43386-680 HUMAN PRESCRIPTION DRUG Pentazocine Hydrochloride and Naloxone Hydrochloride Pentazocine Hydrochloride and Naloxone Hydrochloride TABLET ORAL 20110511 ANDA ANDA075735 GAVIS Pharmaceuticals, LLC NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE .5; 50 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIV 43386-710_f64d4a27-558a-4395-959a-728316ac215e 43386-710 HUMAN PRESCRIPTION DRUG Quinapril HCL and Hydrochlorothiazide Quinapril HCl and Hydrochlorothiazide TABLET ORAL 20110715 ANDA ANDA076374 Gavis Pharmaceuticals, LLC. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43386-711_f64d4a27-558a-4395-959a-728316ac215e 43386-711 HUMAN PRESCRIPTION DRUG Quinapril HCL and Hydrochlorothiazide Quinapril HCL and Hydrochlorothiazide TABLET ORAL 20110715 ANDA ANDA076374 Gavis Pharmaceuticals, LLC. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43386-712_f64d4a27-558a-4395-959a-728316ac215e 43386-712 HUMAN PRESCRIPTION DRUG Quinapril HCL and Hydrochlorothiazide Quinapril HCL and Hydrochlorothiazide TABLET ORAL 20110715 ANDA ANDA076374 Gavis Pharmaceuticals, LLC. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43393-203_1a89fe3a-2524-4009-b71f-9f50920a914b 43393-203 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20130102 ANDA ANDA091667 GenBioPro Inc MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 43405-007_c93b44e7-fb28-4df6-af78-924d05a60192 43405-007 HUMAN OTC DRUG Muscular Balm Capsaicin Menthol Methyl Salicylate OINTMENT TOPICAL 20100514 OTC MONOGRAPH NOT FINAL part348 Borden Company (Private) Limited CAPSAICIN; MENTHOL; METHYL SALICYLATE .15; 13.5; 30 g/100g; g/100g; g/100g 43405-008_242fba8f-37fd-4955-8db7-8b8359664ed7 43405-008 HUMAN OTC DRUG Eagle Medicated Menthol Methyl Salicylate OIL TOPICAL 20120514 OTC MONOGRAPH NOT FINAL part348 Borden Company (Private) Limited MENTHOL; METHYL SALICYLATE 14.5; 30 g/100mL; g/100mL 43406-0001_76f58cdb-6ab5-469d-beb0-fade31cbffde 43406-0001 HUMAN OTC DRUG Acne HP Carbo Animalis, Activated Charcoal, Potassium Dichromate, Sodium Chloride, Pulsatilla Vulgaris, Sepia Offcinalis Juice, Silicon Dioxide, Sulfur, Zinc LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ACTIVATED CHARCOAL; CARBO ANIMALIS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CHLORIDE; SULFUR; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0002_e4650110-a3f1-47e7-a571-4a5d55cc75e4 43406-0002 HUMAN OTC DRUG Allergy HP Onion, Ambrosia Artemisiifolia, Arsenic Trioxide, Activated Charcoal, Euphrasia Stricta, Strychnos Nux-Vomica Seed, Pulsatilla Vulgaris, Solidago Virgaurea Flowering Top, Sulfur LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ACTIVATED CHARCOAL; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; ONION; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0003_f5197199-e91f-4a35-94b3-a2adfd2796b0 43406-0003 HUMAN OTC DRUG Anxiety HP Arsenic Trioxide, Calcium Carbonate, Strychnos Ignatii Seed, Potassium Carbonate, Lachesis Muta Venom, Sodium Chloride, Phosphorus, Pulsatilla LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; CALCIUM CARBONATE; LACHESIS MUTA VENOM; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0004_3fddabd3-cf6d-4201-b346-946ad4c0aacc 43406-0004 HUMAN OTC DRUG Anxiety II HP Aconitum Napellus 30C, Arsenic Trioxide 30C, Belladonna Leaf 30C, Calcium Carbonate 30C, Human Breast Tumor Cell 30C, Causticum 30C, Gelsemium Sempervirens Root 30C, Lachesis Muta Venom 30C, Mercury 30C, Sodium Chloride 30C, Nitric Acid 30C, Phosphorus 30C, Posion Oak Extract 30C LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BELLADONNA LEAF; CALCIUM CARBONATE; CAUSTICUM; GELSEMIUM SEMPERVIRENS ROOT; HUMAN BREAST TUMOR CELL; LACHESIS MUTA VENOM; MERCURY; NITRIC ACID; PHOSPHORUS; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0005_73b8ff54-c486-48e4-92b2-d70e5f790f89 43406-0005 HUMAN OTC DRUG Arthritis HP Apis Mellifera, Bryonia Alba Root, Causticum, Colchicum Autumnale Bulb, Kalmia Latifolia Leaf, Ledum Palustre Twig, Pulsatilla Vulgaris, Rhododenron Aureum LEaf, Toxicodendren Pubescens Leaf LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. APIS MELLIFERA; BRYONIA ALBA ROOT; CAUSTICUM; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0006_eb0f9c1b-a3a2-4fae-9093-2c8be348b1a1 43406-0006 HUMAN OTC DRUG Wheezing HP Arsenic Trioxide, Belladonna Leaf, Ipecac, Potassium Carbonate, Lobelia Inflata, Sodium Sulfate, Silicon Dioxide LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; BELLADONNA LEAF; IPECAC; LOBELIA INFLATA; POTASSIUM CARBONATE; SILICON DIOXIDE; SODIUM SULFATE 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0009_92914a42-75a8-4871-bdbf-2b849b76bcb6 43406-0009 HUMAN OTC DRUG BONE REPAIR HP Sodium Borate, Calcium Carbonate, Calcium Fluoride, Tribasic Calcium Phosphate, Eupatorium Perfoliatum Flowering Top, Iron, Hekla Lava, Hydrofluoric Acid, Toxicodendron Pubescens Leaf, Ruta Graveolens Flowering Top, Silicon Dioxide, Comfrey Leaf LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. CALCIUM CARBONATE; CALCIUM FLUORIDE; COMFREY LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; HEKLA LAVA; HYDROFLUORIC ACID; IRON; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SODIUM BORATE; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0010_bd1dabe2-4df5-4473-8364-ab6f89115e86 43406-0010 HUMAN OTC DRUG Bronchi HP Activated Charcoal, Copper, Drosera Rotundifolia, Ipecac, Lachesis Muta Venom, Lobelia Inflata, Phosphorus, Pulsatilla Vulgaris, Rumex Crispus Root, Spongia Officinalis Skeleton, Roasted LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ACTIVATED CHARCOAL; COPPER; DROSERA ROTUNDIFOLIA; IPECAC; LACHESIS MUTA VENOM; LOBELIA INFLATA; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0011_44f82d12-c64b-4df9-889b-dc87f5883baf 43406-0011 HUMAN OTC DRUG Candida HP Echinacea Purpurea, Baptisia Tinctoria Root, Glycyrrhiza Glabra, Astragalus Nuttallii Leaf, Sodium Borate, Oyster Shell Calcium Carbonate, Crude, Wood Creosote, Lycopodium Clavatum Spore, Sodium Phosphate, Dibasic Heptahydrate, Nitric Acid, Strychnos Nux-Vomica Seed, Phosphoric Acid, Pulsatilla Vulgaris, Sepia Officinalis Juice, Candida Albicans LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ASTRAGALUS NUTTALLII LEAF; BAPTISIA TINCTORIA ROOT; CANDIDA ALBICANS; CANDIDA ALBICANS; CANDIDA ALBICANS; ECHINACEA PURPUREA; GLYCYRRHIZA GLABRA; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM BORATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; WOOD CREOSOTE 6; 3; 10; 200; 30; 1; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0012_ff3fae0b-24f4-4f3c-ba85-10eca0cdbc88 43406-0012 HUMAN OTC DRUG Cholesterol HP Baptisia Tinctoria Root, Silybum Marianum Seed, Chelidonium Majus, Iodine, Lachesis Muta Venom, Veronicastrum Virginicum Root, Sodium Chloride, Strychnos Nux-Vomica See, Phosphoric Acid LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. BAPTISIA TINCTORIA ROOT; CHELIDONIUM MAJUS; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SILYBUM MARIANUM SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; VERONICASTRUM VIRGINICUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0013_f77db443-03c0-4046-8059-c0d4c74357e8 43406-0013 HUMAN OTC DRUG Cold Sore HP Juglan Cinerea Branch Bark/Root Bark, Potassium Iodide, Lycopodium Clavatum Spore, Mercury, Sodium Chloride, Nitric Acid, Phosphorus, Ranunculus Bulbosus, Toxicodendron Pubescens Leaf, Sepia Officinalis Juice, Thuja Occidentalis Leafy Twig LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. JUGLANS CINEREA BRANCH BARK/ROOT BARK; LYCOPODIUM CLAVATUM SPORE; MERCURY; NITRIC ACID; PHOSPHORUS; POTASSIUM IODIDE; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0014_d550ecd4-1419-445d-84a6-283dae38ba95 43406-0014 HUMAN OTC DRUG COUGH HP Arsenic Trioxide, Bryonia Alba Root, Cupric Acetate, Drosera Rotundifolia, Ipecac, Potassium Carbonate, Phosphorus, Pulsatilla Vulgaris, Spongia Officinalis Skeleton, Roasted LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPECAC; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0015_66c900b0-533e-4d0f-b709-4a7a8a63c27b 43406-0015 HUMAN OTC DRUG CYSTOGES HP Berberis Vulgaris Root Bark, Lytta Vesicatoria, Clematis Recta Flowering Top, Canis Lupus Familiaris Milk, Lycopodium Clavatum Spore, Pulsatilla Vulgaris, Sarsaparilla, Sepia Officinalis Juice, Delphinium Staphysagria Seed LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. BERBERIS VULGARIS ROOT BARK; CANIS LUPUS FAMILIARIS MILK; CLEMATIS RECTA FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PULSATILLA VULGARIS; SARSAPARILLA; SEPIA OFFICINALIS JUICE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0017_db7d1ef7-bb7d-4f19-a7c6-34002ac9079e 43406-0017 HUMAN OTC DRUG DIZZINESS HP Oyster Shell Calcium Carbonate Crude, Chenopodium Ambrosioides, Anamirta Cocculus Seed, Conium Maculatum Flowering Top, Strychnos Nux-Vomica Seed, Phosphorus, Pulsatilla Vulgaris, Silicon Dioxide LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ANAMIRTA COCCULUS SEED; CHENOPODIUM AMBROSIOIDES; CONIUM MACULATUM FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0018_5b11c3df-36e7-41e9-bcca-08df6d2217d3 43406-0018 HUMAN OTC DRUG EAR INFLAM HP Atropa Belladonna Root 30X, Conium Maculatum Flowering Top 30X, Solanum Dulcamara Top 30X, Calcium Sulfide 30X, Potassium Dichromate 30X, Mercurius Solubilis 30X, Pulsatilla Vulgaris 30X, Silicon Dioxide 30X LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ATROPA BELLADONNA ROOT; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; MERCURIUS SOLUBILIS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SOLANUM DULCAMARA TOP 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0019_f932d6f9-1781-4dd2-bb7c-44b40c2654a7 43406-0019 HUMAN OTC DRUG ECZEMA HP Arsenic Trioxide 30X, Oyster Shell Calcium Carbonate, Crude 30X, Graphite 30X, Mercurius Solubilis 30X, Daphne Mezereum Bark 30X, Toxicodendron Pubescens Leaf 30X, Sepia Officinalis Juice 30X, Sulfur 30X LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; DAPHNE MEZEREUM BARK; GRAPHITE; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE; SULFUR; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0020_0159af68-7743-4adf-bbce-ec7ce5016c16 43406-0020 HUMAN OTC DRUG ENURESIS HP Apis Mellifera 30C, Silver Nitrate 30C, Barium Carbonate 30C, Atropa Belladonna 30C, Causticum 30C, Equisetum Hyemale 30C, Iodine 30C, Wood Creosote 30C, Sodium Chloride 30C, Nitric Acid 30C, Phosphorus 30C, Pulsatilla Vulgaris 30C, Thuja Occidentalis Leafy Twig 30C LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. APIS MELLIFERA; ATROPA BELLADONNA; BARIUM CARBONATE; CAUSTICUM; EQUISETUM HYEMALE; IODINE; NITRIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; SILVER NITRATE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; WOOD CREOSOTE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0021_b995f789-981d-46b7-93f9-6863a722cdc8 43406-0021 HUMAN PRESCRIPTION DRUG FIBROMYALGIA HP Aluminum Oxide 30C, Silver Nitrate 30C, Berberis Vulgaris Fruit 30C, Conium Maculatum Flowering Top 30C, Iron 30C, Gelsemium Sempervirens Root 30C, Guaiacum Officinale Resin 30C, Hydrogen 30C, Lachesis Muta Venom 30C, Phosphoric Acid 30C, Toxicodendron Pubescens Leaf 30C LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ALUMINUM OXIDE; BERBERIS VULGARIS FRUIT; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GUAIACUM OFFICINALE RESIN; HYDROGEN; IRON; LACHESIS MUTA VENOM; PHOSPHORIC ACID; SILVER NITRATE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0022_49afea13-0cce-439e-82a6-ccfeb6b04309 43406-0022 HUMAN OTC DRUG FLU HP Aconitum Napellus, Arsenic Trioxide, Atropa Belladonna, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Ferrum Phosphoricum, Gelsemium Sempervirens Root LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0025_1557667d-81de-48e0-8063-1bd56d01fec9 43406-0025 HUMAN OTC DRUG HEADACHE HP Silver Nitrate, Atropa Belladonna, Bryonia Alba Root, Gelsemium Sempervirens Root, Nitroglycerin, Lachesis Muta Venom, Lycopodium Clavatum Spore, Melilotus Officinalis Top, Sodium Chloride, Strychnos Nux-Vomica Seed, Silicon Dioxide, Spigelia Anthelmia LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ATROPA BELLADONNA; BRYONIA ALBA ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MELILOTUS OFFICINALIS TOP; NITROGLYCERIN; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0026_716f8bac-c57c-4925-95b0-ef44809c7b43 43406-0026 HUMAN OTC DRUG HYPERT HP Arnica Montana, Gold, Selenicereus Grandiflorus Stem, Oyster Shell Calcium Carbonate, Crude, Sodium Chloride, Strychnos Nux-Vomica Seed, Phosphorus, Solidago Virgaurea Flowering Top LIPSTICK ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARNICA MONTANA; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SELENICEREUS GRANDIFLORUS STEM; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0027_ef899e61-b830-4060-a350-e70a8a72fed4 43406-0027 HUMAN OTC DRUG INSOMNIA HP Arsenic Trioxide, Arabica Coffee Bean, Potassium Carbonate, Magnesium Carbonate, Strychnos Nux-Vomica Seed, Passiflora Incarnata Top, Sepia Officinalis Juice, Valerian LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; MAGNESIUM CARBONATE; PASSIFLORA INCARNATA TOP; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0028_5b40b6e3-6cc5-486b-8e4c-93594be11baf 43406-0028 HUMAN OTC DRUG LIVER GALLBLADDER HP Atropa Belladonna, Chelidonium Majus, Citrullus Colocynthis Fruit Pulp, Lycopodium Clavatum Spore, Sodium Sulfate, Strychnos Nux-Vomica Seed, Phosphorus, Pulsatilla Vulgaris, Veratrum Album Root LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ATROPA BELLADONNA; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0030_773b6f34-fff9-4aad-869e-6dab1ba19e7b 43406-0030 HUMAN OTC DRUG MENOPAUSE HP Atropa Belladonna, Black Cohosh, Lachesis Muta Venom, Strychnos Nux-Vomica Seed, Pulsatilla Vulgaris, Claviceps Purpurea Sclerotium, Sepia Officinalis Juice, Ustilago Maydis LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ATROPA BELLADONNA; BLACK COHOSH; CLAVICEPS PURPUREA SCLEROTIUM; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; USTILAGO MAYDIS 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0032_67096693-fba2-4dbb-b473-c11d28f66957 43406-0032 HUMAN OTC DRUG NAUSEA VOMITING HP Arsenic Trioxide, Anamirta Cocculus Seed, Ipecac, Wood Creosote, Kerosene, Sanguinaria Canadensis Root, Tobacco Leaf LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ANAMIRTA COCCULUS SEED; ARSENIC TRIOXIDE; IPECAC; KEROSENE; SANGUINARIA CANADENSIS ROOT; TOBACCO LEAF; WOOD CREOSOTE 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0033_4450d0ab-885c-4734-aad8-b997deb1d8ea 43406-0033 HUMAN OTC DRUG NEURO PAIN HP Amanita Muscaria Var. Muscaria, Onion, Arnica Montana Root, Hypericum Perforatum, Lycopodium Clavatum Spore, Mercurius Solubilis, Phosphorus, Lead LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. AMANITA MUSCARIA VAR. MUSCARIA; ARNICA MONTANA ROOT; HYPERICUM PERFORATUM; LEAD; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; ONION; PHOSPHORUS 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0034_30fdd1d1-f8f9-49b4-8eed-e70e5091cfaa 43406-0034 HUMAN OTC DRUG OSTEOPOROSIS HP Arsenic Trioxide, Gold, Oyster Shell Calcium Carbonate, Crude, Calcium Fluoride, Hydrofluoric Acid, Hekla Lava, Toxicodendron Pubescens Leaf, Silicon Dioxide, Delphinium Staphisagria Seed, Comfrey Leaf LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; CALCIUM FLUORIDE; CALCIUM PHOSPHATE; COMFREY LEAF; DELPHINIUM STAPHISAGRIA SEED; GOLD; HEKLA LAVA; HYDROFLUORIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0035_50e58a51-4a75-4490-8aa3-b627c436e53c 43406-0035 HUMAN OTC DRUG RIGIDITY HP Aluminum Oxide, Arsenic Trioxide, Causticum, Conium Maculatum Flowering Top, Cupric Acetate, Gelsemium Sempervirens Root, Strychnos Ignatii Seed, Lachesis Muta Venom, Mercurius Solubilis, Phosphorus, Lead, Zinc LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ALUMINUM OXIDE; ARSENIC TRIOXIDE; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; CUPRIC ACETATE; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; LEAD; MERCURIUS SOLUBILIS; PHOSPHORUS; STRYCHNOS IGNATII SEED; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0037_fc6ae8a0-0ba3-4354-9645-fac9d9e9f33a 43406-0037 HUMAN OTC DRUG PMS HP Atropa Belladonna, Lachesis Muta Venom, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Strychnos Nux-Vomica Seed, Pulsatilla Vulgaris, Sepia Officinalis Juice LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ATROPA BELLADONNA; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0038_fc9c1141-9ff0-4a21-b676-cd0724d01ea1 43406-0038 HUMAN OTC DRUG PNEUMO HP Ammonium Chloride, Antimony Potassium Tartrate, Arsenic Trioxide, Oyster Shell Calcium Carbonate, Crude, Lobelia Inflata, Sodium Sulfate, Spongia Officinalis Skeleton, Roasted, Phosphorus LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. AMMONIUM CHLORIDE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; LOBELIA INFLATA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43406-0039_168c2935-de22-4a32-83d5-5b51d15e44f0 43406-0039 HUMAN OTC DRUG PROSTATE HP Clematis Recta Flowering Top, Conium Maculatum Flowering Top, Lycopodium Clavatum Spore, Mercuric Chloride, Pulsatilla Vulgaris, Saw Palmetto, Selenium, Sepia Officinalis Juice, Delphinium Staphisagria Seed, Thuja Occidentalis Leafy Twig LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; PULSATILLA VULGARIS; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0040_06739c6b-bbf8-4691-80b3-f15cf71a507c 43406-0040 HUMAN OTC DRUG PSORIASIS HP Clematis Recta Flowering Top, Arsenic Triiodide, Sodium Borate, Oyster Shell Calcium Carbonate, Crude, Graphite, Daphne Mezereum Bark, Proteus Morganii, Sodium Chloride, Phytolacca Americana Root, Sepia Officinalis Juice, Sulfur, Thyroid LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIIODIDE; CLEMATIS RECTA FLOWERING TOP; DAPHNE MEZEREUM BARK; GRAPHITE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; PROTEUS MORGANII; SEPIA OFFICINALIS JUICE; SODIUM BORATE; SODIUM CHLORIDE; SULFUR; THYROID, UNSPECIFIED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL 43406-0042_97f36e74-0594-44a4-99e1-7f14bcdbbd3e 43406-0042 HUMAN OTC DRUG SCIATICA HP Aesculus Hippocastanum Bark, Aconitum Napellus, Colchicum Autumnale Bulb, Hypericum Perforatum, Magnesium Phosphate, Dibasic Trihydrate, Lead, Toxicodendron Pubescens Leaf, Arnica Montana LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ACONITUM NAPELLUS; AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; COLCHICUM AUTUMNALE BULB; HYPERICUM PERFORATUM; LEAD; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0043_b36a9804-6dc1-4e08-994f-2d708f28d830 43406-0043 HUMAN OTC DRUG SCROPHULOUS HP Barium Carbonate, Bromine, Oyster Shell Calcium Carbonate, Crude, Conium Maculatum Flowering Top, Ferrous Iodide, Mercurius Solubilis, Phytolacca Americana Root, Toxicodendron Pubescens Leaf, Silicon Dioxide LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. BARIUM CARBONATE; BROMINE; CONIUM MACULATUM FLOWERING TOP; FERROUS IODIDE; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0045_5f6dab29-b520-4200-bbcd-bee10f7afeb3 43406-0045 HUMAN OTC DRUG SINUS HP Ambrosia Artemisiifolia, Arsenic Trioxide, Calcium Sulfide, Potassium Dichromate, Potassium Sulfate, Lycopodium Clavatum Spore, Mercurius Solubilis, Sodium Chloride, Phosphorus, Pulsatilla Vulgaris, Sepia Officinalis Juice, Silicon Dioxide, Thuja Occidentalis Leafy Twig LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; CALCIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHOSPHORUS; POTASSIUM DICHROMATE; POTASSIUM SULFATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0047_5873541a-980c-411f-8567-f73581e9adeb 43406-0047 HUMAN OTC DRUG SUCUR II Silver, Giant Puffball, Colchicum Autumnale Bulb, Chamaelirium Luteum Root, Strychnos Ignatii Seed, Lactic Acid, DL-, Lycopodium Clavatum Spore, Phosphoric Acid, Phosphorus, Syzygium Cumini Seed, Uranyl Nitrate Hexahydrate LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. CHAMAELIRIUM LUTEUM ROOT; COLCHICUM AUTUMNALE BULB; GIANT PUFFBALL; LACTIC ACID, DL-; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; SILVER; STRYCHNOS IGNATII SEED; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0048_00e346e5-b2be-4f05-ba56-34808c57727f 43406-0048 HUMAN PRESCRIPTION DRUG SURG HP Echinacea Angustifolia, Hypericum, Phosphorus, Rancid Beef, Silicon Dioxide, Delphinium Staphisagria Seed, Delphinium Staphisagria Seed, Comfrey Root, Arnica Montana Root LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARNICA MONTANA ROOT; ARNICA MONTANA ROOT; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; PHOSPHORUS; RANCID BEEF; SILICON DIOXIDE 200; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0049_e815ea3d-8269-45cd-b014-c9998a041ec6 43406-0049 HUMAN OTC DRUG THYROID HP Barium Carbonate, Oyster Shell Calcium Carbonate, Crude, Fucus Vesiculosus, Iodine, Sodium Chloride, Pulsatilla Vulgaris, Spongia Officinalis Skeleton, Roasted, Thyroid LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. BARIUM CARBONATE; FUCUS VESICULOSUS; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID, UNSPECIFIED 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0050_0a792f69-2f64-49d1-aa0f-71ea92b0a80c 43406-0050 HUMAN OTC DRUG Varico HP Calcarea Fluorica, Activated Charcoal, Hamamelis Virginiana Root Bark / Stem Bark, Lachesis Muta Venom, Lycopodium Clavatum Spore, Pulsatilla Vulgaris, Claviceps Purpurea Sclerotium, Delphinium Staphisagrea Seed, Zinc LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ACTIVATED CHARCOAL; CALCIUM FLUORIDE; CLAVICEPS PURPUREA SCLEROTIUM; DELPHINIUM STAPHISAGRIA SEED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0051_e15421e9-1662-45e1-aaf1-92e9fb7f123b 43406-0051 HUMAN OTC DRUG VERMA HP Barium Carbonate, Oyster Shell Calcium Carbonate, Crude, Artemisia Cina Flower, Iron, Mercuric Sulfate, Sodium Phosphate, Dibasic, Heptahydrate, Schoenocaulon Officinale Seed, Spigelia Anthelmia, Teucrium Marum LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARTEMISIA CINA FLOWER; BARIUM CARBONATE; IRON; MERCURIC SULFATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SCHOENOCAULON OFFICINALE SEED; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SPIGELIA ANTHELMIA; TEUCRIUM MARUM 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0052_17a7c6c8-0613-4055-9350-4f213f853267 43406-0052 HUMAN OTC DRUG VIRAL HP Arsenic Trioxide, Atropa Belladonna, Echinacea Angustifolia, Eupatorium Perfoliatum Flowering Top, Gelsemium Sempervirens Root, Lycopodium Clavatum Spore, Phosphoric Acid, Phosphorus, Rancid Beef, Toxicodendron Pubescens Leaf LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0053_b0c4eb8c-a36d-4d01-aa1c-d9075e1f720c 43406-0053 HUMAN OTC DRUG Weight Management HP Arsenic Trioxide, Gold, Oyster Shell Calcium Carbonate, Crude, Iodine, Lycopodium Clavatum Spore, Sodium Chloride, Strychnos Nux-Vomica Seed, Phosphoric Acid, Phosphorus, Phytolacca Americana Root, Pulsatilla Vulgaris, Sepia Officinalis Juice, Sulfur LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; GOLD; IODINE; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0069_9b73d14c-7886-46ee-b4d5-25cf27bf2349 43406-0069 HUMAN OTC DRUG COLD Baptisia Tintoria Root, Echinacea Angustifolia, Eupatoriom Perfoliatum Flowering Top, Lomatium Dissectum Root, Pueraria Montana Var. Lobata Root, Trifolium Pratense Flower, Pnytolacca Americana Root, Onion, Arsenic Triiodode, Barium Carbonate, Bromide, Oyster Shell Calcium Carbonate Crude, Potassium Chloride, Mercurius Solubilis, Silicon Dioxide LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIIODIDE; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BROMINE; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; ONION; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM CHLORIDE; PUERARIA MONTANA VAR. LOBATA ROOT; SILICON DIOXIDE; TRIFOLIUM PRATENSE FLOWER 12; 3; 12; 12; 3; 3; 12; 12; 12; 12; 6; 12; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0070_be3b9faf-57f1-4278-bc8a-12f572513d00 43406-0070 HUMAN OTC DRUG CONSTIPATION Magnesium Carbonate, Magnesium Chloride, Aesculus Hippocastanum, Flos, Potassium Alum, Aluminum Oxide, Bryonia Alba Root, Strychnos Nux-Vomica Seed, Silicon Dioxide LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. AESCULUS HIPPOCASTANUM FLOWER; ALUMINUM OXIDE; BRYONIA ALBA ROOT; MAGNESIUM CARBONATE; MAGNESIUM CHLORIDE; POTASSIUM ALUM; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED 12; 12; 12; 3; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0071_d3b754f0-5a03-44e6-bbc9-0ace31b246ce 43406-0071 HUMAN OTC DRUG DEPRESSION American Ginseng, Black Cohosh, Spigelia Anthelmia, Silver Nitrate, Arsenic Trioxide, Gold, Strychnos Ignatti Seed, Lachesis Muta Venom, Lycopodium Clavatum Spore, Sodium Chloride, Phosphoric Acid, Platinum, Pulsatilla Vulgaris, Sepia Officinalis Juice, Thuja Occidentalis Leafy Twig, LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. AMERICAN GINSENG; ARSENIC TRIOXIDE; BLACK COHOSH; GOLD; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PLATINUM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; STRYCHNOS IGNATII SEED; THUJA OCCIDENTALIS LEAFY TWIG 3; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0072_397400d7-25b3-409f-ab41-b797da25e64d 43406-0072 HUMAN OTC DRUG DIGESTION Centella Asiatica, Gentiana Lutea Root, Sambucus Niger Flowering Top, Arsenic Trioxide, Bismuth Subnitrate, Activated Charcoal, Potassium Dichromate, Lycopodium Clavatium Spore, Strychnos Nux-Vomica Seed, Phosphorus, Pulsatilla VulgarisPhosphorus, Pulsatilla Vulgaris LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; BISMUTH SUBNITRATE; CENTELLA ASIATICA; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED 12; 12; 12; 1; 3; 12; 12; 12; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0073_c8d4ff50-4e6c-4d09-964c-dfdea85ca072 43406-0073 HUMAN OTC DRUG EYE - CATARACT Euphrasia Stricta, Spigelia Anthelmia, Bilberry, Arsenic Trioxide, Calcium Fluoride, Causticum, Gelsemium Sempervirens Root, Magnesium Carbonate, Mercurius Solubilis, Osmium, Phosphorus, Physostigma Venenosum Seed , Silicon Dioxide LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; BILBERRY; CALCIUM FLUORIDE; CAUSTICUM; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM CARBONATE; MERCURIUS SOLUBILIS; OSMIUM; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA 12; 3; 12; 12; 3; 12; 12; 12; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0075_e2cd08dd-c58b-4575-ab45-330e96c11ea6 43406-0075 HUMAN OTC DRUG HIVES Echina Angustifolia, Apis Mellifera, Arsenic Trioxide, Phenol, Ledum Palustre, Toxicodendron Pubescens Leaf, Sulfur, Urtica Urens LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creationa, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ECHINACEA ANGUSTIFOLIA; LEDUM PALUSTRE TWIG; PHENOL; SULFUR; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 12; 12; 3; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0078_476a9f9a-ec5d-49c0-9189-1eb55be43416 43406-0078 HUMAN OTC DRUG INJURY Calendula Officinalis Flowering Top, Comfrey Root, Arnica Montana, Bellis Perennis, Bryonia Alba Root, Hypericum Perforatum, Ledum Palustre Twig, Phosphorus, Toxicodendron Pubescens Leaf, Ruta Graveolens Flowering Top, Delphinium Staphisagria Seed, Rancid Beef LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; RANCID BEEF; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 3; 12; 12; 12; 12; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43406-0095_c66bf8d1-7f22-4308-9528-becd068ace49 43406-0095 HUMAN OTC DRUG EDEMA HP Apis Mellifera 30X, Arsenic Trioxide 30X, Cinchona Officinalis Bark 30X, Digitalis 30X, Lachesis Muta Venom 30X, Lycopodium Clavatum Spore 30X, Sodium Sulfate 30X, Toxicodendron Pubescens Leaf 30X, Sambucus Nigra Flowering Top 30X, Strophanthus Hispidus Seed 30X LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; DIGITALIS; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SAMBUCUS NIGRA FLOWERING TOP; SODIUM SULFATE; STROPHANTHUS HISPIDUS SEED; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0099_40cf4b0e-e82f-449a-bc11-d7c6b9a97664 43406-0099 HUMAN OTC DRUG MOTION SICKNESS HP Arnica Montana, Bryonia Alba Root, Quinine Sulfate, Anamirta Cocculus Seed, Conium Maculatum Flowering Top, Strychnos Ignatii Seed, Ipecac, Potassium Carbonate, Strychnos Nux-Vomica Seed, Sepia Officinalis Juice, Tobacco Leaf, Veratrum Album Root LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ANAMIRTA COCCULUS SEED; ARNICA MONTANA; BRYONIA ALBA ROOT; CONIUM MACULATUM FLOWERING TOP; IPECAC; POTASSIUM CARBONATE; QUININE SULFATE; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0108_332d3cbc-b705-4217-9eef-1b12b4c60c06 43406-0108 HUMAN OTC DRUG VITAL HP Arsenic Trioxide, Cadmium Sulfate, Oyster Shell Calcium Carbonate, Crude, Human Breast Tumor Cell, Conium Maculatum Flowering Top, Lycopodium Clavatum Spore, Gonorrheal Urethral Secretion Human, Phytolacca Americana Root, Scabies Lesion Lysate (Human), Sulfur, Treponemic Skin Canker Human, Thuja Occidentalis Leafy Twig LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; CADMIUM SULFATE; CONIUM MACULATUM FLOWERING TOP; GONORRHEAL URETHRAL SECRETION HUMAN; HUMAN BREAST TUMOR CELL; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; SCABIES LESION LYSATE (HUMAN); SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TREPONEMIC SKIN CANKER HUMAN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0112_0d828797-eebd-4727-8d0d-9a17e790f5d0 43406-0112 HUMAN OTC DRUG RAD HP Arsenic Trioxide, Baptisia Tinctoria Root, Cadmium Sulfide, Calcium Fluoride, Lytta Vesicatoria, Human Breast Tumor Cell, Cinchona Officinalis Bark, Cobalt, Conium Maculatum Flowering Top, Hydrofluoric Acid, Goldenseal, Iodine, Ipecac, Wood Creosote, Phosphorus, Radium Bromide, Sepia Officinalis Juice, Silicon Dioxide, Uranyl Nitrate Hexahydrate LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CADMIUM SULFIDE; CALCIUM FLUORIDE; CINCHONA OFFICINALIS BARK; COBALT; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; HUMAN BREAST TUMOR CELL; HYDROFLUORIC ACID; IODINE; IPECAC; LYTTA VESICATORIA; PHOSPHORUS; RADIUM BROMIDE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; URANYL NITRATE HEXAHYDRATE; WOOD CREOSOTE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0113_d6b36a29-3060-4584-85dd-239ed337a713 43406-0113 HUMAN OTC DRUG CHEM HP Apis Mellifera, Arsenic Trioxide, Cadmium Sulphate, Oyster Shell Calcium Carbonate Crude, Activated Charcoal, Chelidonium Majus, Cinchona Officinalis Bark, Lycopodium Clavatum Spore, Mercurius Solubilis, Sodium Chloride, Strychnos Nux-Vomica Seed, Phosphorus, Pulsatilla Vulgaris, Sepia Officinalis Juice, Sulphur, Zinc LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ACTIVATED CHARCOAL; APIS MELLIFERA; ARSENIC TRIOXIDE; CADMIUM SULFATE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0127_c17c4aca-37a1-4647-b911-9120ada4f95b 43406-0127 HUMAN OTC DRUG SNORING HP Ailanthus Altissima Flowering Twig, Antimony Potassium Tartrate, Arsenic Trioxide, Atropa Belladonna, Camphor (Natural), Chamomile, Copper, Digitalis, Strychnos Ignatii Seed, Canis Lupus Familiaris Milk, Strychnos Nux-Vomica Seed LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. AILANTHUS ALTISSIMA FLOWERING TWIG; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CAMPHOR (NATURAL); CANIS LUPUS FAMILIARIS MILK; CHAMOMILE; COPPER; DIGITALIS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0131_15eef614-1118-4b42-afa2-7bcc9ef99ec4 43406-0131 HUMAN OTC DRUG Cardio HP Gold, Avena Sativa Flowering Top, Selenicereus Grandiflorus Stem, Digitalis Purpurea Whole, Lycopus Virginicus, Naja Naja Venom, Sodium Chloride, Phosphorus, Pulsatilla Patens, Valerian LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. AVENA SATIVA FLOWERING TOP; DIGITALIS PURPUREA WHOLE; GOLD; LYCOPUS VIRGINICUS; NAJA NAJA VENOM; PHOSPHORUS; PULSATILLA PATENS; SELENICEREUS GRANDIFLORUS STEM; SODIUM CHLORIDE; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43406-0152_ae13b690-a11a-4f95-ba0a-be534a2a9338 43406-0152 HUMAN PRESCRIPTION DRUG STIFF JOINTS HP Bryonia Alba Root, Colchicum Autumnale Bulb, Kalmia Latifolia Leaf, Ledum Palustre Twig, Lycopodium Clavatum Spore, Rhododendron Aureum Leaf, Toxicodendron Pubescens Leaf LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43419-001_e7bb91b4-f4cd-43b0-bb76-429d948a0dd0 43419-001 HUMAN OTC DRUG Sulwhasoo Lumitouch Base OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .498; .588 g/30mL; g/30mL; g/30mL 43419-002_ebf2ff60-8042-49fb-a850-fdd2b5a541e2 43419-002 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation No. 21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .498; .588 g/30mL; g/30mL; g/30mL 43419-003_ebf2ff60-8042-49fb-a850-fdd2b5a541e2 43419-003 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation No. 23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .498; .588 g/30mL; g/30mL; g/30mL 43419-004_832e72a8-86b7-4c44-ba55-9883d79fdafa 43419-004 HUMAN OTC DRUG Sulwhasoo Age-veil UV protection OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 1.8; 3.2; 1.768; .0412 g/40mL; g/40mL; g/40mL; g/40mL; g/40mL 43419-005_8cce279e-f151-4b91-9635-b0002554b109 43419-005 HUMAN OTC DRUG SULWHASOO SNOWISE BRIGHTENING BB BASE NO.1 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20111005 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; .996; 2.352 g/30mL; g/30mL; g/30mL 43419-006_8cce279e-f151-4b91-9635-b0002554b109 43419-006 HUMAN OTC DRUG SULWHASOO SNOWISE BRIGHTENING BB BASE NO.2 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20111005 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; .996; 2.352 g/30mL; g/30mL; g/30mL 43419-007_ebf2ff60-8042-49fb-a850-fdd2b5a541e2 43419-007 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation No. 25 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20111015 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .498; .588 g/30mL; g/30mL; g/30mL 43419-008_2de54174-ec98-41b2-b74e-a21fe8cc8999 43419-008 HUMAN OTC DRUG Sulwhasoo Lumitouch Compact No.21 Natural Beige OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .56; 3.3572; 1.3706 g/14g; g/14g; g/14g 43419-009_2de54174-ec98-41b2-b74e-a21fe8cc8999 43419-009 HUMAN OTC DRUG Sulwhasoo Lumitouch Compact No.23 True Beige OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .56; 3.3572; 1.3706 g/14g; g/14g; g/14g 43419-010_a0f06994-ffcb-49fd-b61c-634696e7aa54 43419-010 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .246; .291 g/30mL; g/30mL; g/30mL 43419-011_a0f06994-ffcb-49fd-b61c-634696e7aa54 43419-011 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .246; .291 g/30mL; g/30mL; g/30mL 43419-012_a0f06994-ffcb-49fd-b61c-634696e7aa54 43419-012 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .246; .291 g/30mL; g/30mL; g/30mL 43419-013_73376ae2-606e-46b1-9749-2427abc3de5e 43419-013 HUMAN OTC DRUG Sulwhasoo Snowise Foundation OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .468; .8667; .1764 g/9g; g/9g; g/9g 43419-014_73376ae2-606e-46b1-9749-2427abc3de5e 43419-014 HUMAN OTC DRUG Sulwhasoo Snowise Foundation OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .468; .8667; .1764 g/9g; g/9g; g/9g 43419-015_91ed8fd4-5c5e-4157-a22c-7d5c51c1a1df 43419-015 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation SPF 25 No.21 Natural Beige OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .352; .4697; .2156 g/11g; g/11g; g/11g 43419-016_91ed8fd4-5c5e-4157-a22c-7d5c51c1a1df 43419-016 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation SPF 25 No 23. True Beige OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .352; .4697; .2156 g/11g; g/11g; g/11g 43419-017_91ed8fd4-5c5e-4157-a22c-7d5c51c1a1df 43419-017 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation SPF 25 No 25. Dark Beige OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .352; .4697; .2156 g/11g; g/11g; g/11g 43419-018_a879375f-07d3-4d04-941a-b31b3122e5dc 43419-018 HUMAN OTC DRUG Sulwhasoo Lumitouch Base SPF 15 No.40 Light Violet OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .249; .294 g/30mL; g/30mL; g/30mL 43419-019_5b8fb785-8257-464b-ba3e-791e1210d5bd 43419-019 HUMAN OTC DRUG Sulwhasoo Lumitouch Base SPF 15 No. 60 Light Green OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .249; .294 g/30mL; g/30mL; g/30mL 43419-020_9b0f74e0-05e8-4d0c-b6e4-fb9e2f15d676 43419-020 HUMAN OTC DRUG Sulwhasoo Lumitouch Base OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .498; .588 mL/30mL; mL/30mL; mL/30mL 43419-021_d7c986c3-d47e-4994-97b5-e0e0c9529ba6 43419-021 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation No.21 Natural Beige OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .498; .588 mL/30mL; mL/30mL; mL/30mL 43419-022_d7c986c3-d47e-4994-97b5-e0e0c9529ba6 43419-022 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation No.21 Natural Beige OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .498; .588 mL/30mL; mL/30mL; mL/30mL 43419-023_31ded521-3a39-4e26-baf8-cd3d448956d2 43419-023 HUMAN OTC DRUG Sulwhasoo EVENFAIR SMOOTHING FOUNDATION SPF25 NO. 2 medium beige OCTINOXATE LIQUID TOPICAL 20121123 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL 43419-024_31ded521-3a39-4e26-baf8-cd3d448956d2 43419-024 HUMAN OTC DRUG Sulwhasoo EVENFAIR SMOOTHING FOUNDATION SPF25 NO. 3 MEDIUM OCHER OCTINOXATE LIQUID TOPICAL 20121123 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL 43419-025_113926fa-00ab-4023-94e2-5181590dcf9c 43419-025 HUMAN OTC DRUG Sulwhasoo EVENFAIR SMOOTHING FOUNDATION SPF25 NO.2 MEDIUM BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20121123 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .32; .4268; .196 g/10g; g/10g; g/10g 43419-026_113926fa-00ab-4023-94e2-5181590dcf9c 43419-026 HUMAN OTC DRUG Sulwhasoo EVENFAIR SMOOTHING FOUNDATION SPF25 NO.3 MEDIUM OCHER OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20121123 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .32; .4268; .196 g/10g; g/10g; g/10g 43419-027_7aafcd71-ba80-4ed2-8b3f-47dd7955ce4b 43419-027 HUMAN OTC DRUG Sulwhasoo evenfair smoothing makeup base NO. 1 OCTINOXATE LOTION TOPICAL 20130215 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL 43419-028_7aafcd71-ba80-4ed2-8b3f-47dd7955ce4b 43419-028 HUMAN OTC DRUG Sulwhasoo EVENFAIR SMOOTHING MAKEUP BASE NO. 2 OCTINOXATE LOTION TOPICAL 20130215 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL 43419-029_67734c96-a867-4277-af5a-4bc3a9440a93 43419-029 HUMAN OTC DRUG Sulwhasoo SNOWISE BRIGHTENING SERUM BB OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.4276; 1.151376; 2.718912 g/30mL; g/30mL; g/30mL 43419-030_67734c96-a867-4277-af5a-4bc3a9440a93 43419-030 HUMAN OTC DRUG SulwhasooSNOWISE BRIGHTENING SERUM BB OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.4276; 1.151376; 2.718912 g/30mL; g/30mL; g/30mL 43419-031_2e0c3863-69ed-4ea6-8a02-924888263cc0 43419-031 HUMAN OTC DRUG SULWHASOO EVENFAIR PERFECTING CUSHION NO.21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-032_2e0c3863-69ed-4ea6-8a02-924888263cc0 43419-032 HUMAN OTC DRUG SULWHASOO EVENFAIR PERFECTING CUSHION NO.23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-033_2e0c3863-69ed-4ea6-8a02-924888263cc0 43419-033 HUMAN OTC DRUG SULWHASOO EVENFAIR PERFECTING CUSHION NO.25 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-034_3f9d14b8-25cf-442b-baff-466d1ba03b9f 43419-034 HUMAN OTC DRUG SULWHASOO EVENFAIR COMPACT NO.21 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE .22; 2.2 g/11g; g/11g 43419-035_3f9d14b8-25cf-442b-baff-466d1ba03b9f 43419-035 HUMAN OTC DRUG SULWHASOO EVENFAIR COMPACT NO.24 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE .22; 2.2 g/11g; g/11g 43419-036_3f9d14b8-25cf-442b-baff-466d1ba03b9f 43419-036 HUMAN OTC DRUG SULWHASOO EVENFAIR COMPACT NO.26 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE .22; 2.2 g/11g; g/11g 43419-301_f4201a49-ddb2-4ff8-a113-a26156c4c029 43419-301 HUMAN OTC DRUG IOPE RETIGEN ESSENCE DUAL CONCEALER OCTINOXATE and TITANIUM DIOXIDE KIT 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC 43419-302_9e65df95-5e66-463a-ac85-0dcd1fab6b05 43419-302 HUMAN OTC DRUG IOPE RETIGEN GLOW COVER CAKE NO.21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .7; .3486; .2744 g/14g; g/14g; g/14g 43419-303_9e65df95-5e66-463a-ac85-0dcd1fab6b05 43419-303 HUMAN OTC DRUG IOPE RETIGEN GLOW COVER CAKE NO.23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .7; .3486; .2744 g/14g; g/14g; g/14g 43419-304_5c265840-4e76-4bd7-9d3b-bdbc7f428255 43419-304 HUMAN OTC DRUG IOPE RETIGEN MOISTURE BASE NATURAL YELLOW OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.45; .581; .686 g/35mL; g/35mL; g/35mL 43419-305_5c265840-4e76-4bd7-9d3b-bdbc7f428255 43419-305 HUMAN OTC DRUG IOPE RETIGEN MOISTURE BASE NATURAL GREEN OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.45; .581; .686 g/35mL; g/35mL; g/35mL 43419-306_6e77ad66-0751-436d-bf30-bafa7749d22c 43419-306 HUMAN OTC DRUG IOPE RETIGEN LUMINOUS BASE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.45; .581; .686 g/35mL; g/35mL; g/35mL 43419-307_b00ed4ca-3f94-40c6-8d5c-1566afa6e5f1 43419-307 HUMAN OTC DRUG IOPE RETIGEN MOISTURE FOUNDATION NO.17 SPF22 PA PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; .8715; .343 g/35mL; g/35mL; g/35mL 43419-308_b00ed4ca-3f94-40c6-8d5c-1566afa6e5f1 43419-308 HUMAN OTC DRUG IOPE RETIGEN MOISTURE FOUNDATION NO.21 SPF22 PA PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; .8715; .343 g/35mL; g/35mL; g/35mL 43419-309_b00ed4ca-3f94-40c6-8d5c-1566afa6e5f1 43419-309 HUMAN OTC DRUG IOPE RETIGEN MOISTURE FOUNDATION NO.23 SPF22 PA PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; .8715; .343 g/35mL; g/35mL; g/35mL 43419-310_09c83fd7-f2d9-4fa6-83f4-89c8384c3df0 43419-310 HUMAN OTC DRUG AMOREPACIFIC NATURAL PROTECTOR OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .07; .19; .00025 mg/mL; mg/mL; mg/mL 43419-311_f3c9d5d7-2707-499a-a337-86d6a55b381c 43419-311 HUMAN OTC DRUG IOPE RETIGEN MOISTURE TWIN CAKE NO.21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .84; .868; .4116 g/14g; g/14g; g/14g 43419-312_f3c9d5d7-2707-499a-a337-86d6a55b381c 43419-312 HUMAN OTC DRUG IOPE RETIGEN MOISTURE TWIN CAKE NO.23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .84; .868; .4116 g/14g; g/14g; g/14g 43419-313_f3c9d5d7-2707-499a-a337-86d6a55b381c 43419-313 HUMAN OTC DRUG IOPE RETIGEN MOISTURE TWIN CAKE NO.17 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .84; .868; .4116 g/14g; g/14g; g/14g 43419-314_0323917f-ea6f-435b-af30-a19958aea323 43419-314 HUMAN OTC DRUG IOPE RETIGEN SMOOTHING PACT NO.1 SPF25 PA PLUS PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .84; .86912; .4116 g/14g; g/14g; g/14g 43419-315_0323917f-ea6f-435b-af30-a19958aea323 43419-315 HUMAN OTC DRUG IOPE RETIGEN SMOOTHING PACT NO.2 SPF25 PA PLUS PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .84; .86912; .4116 g/14g; g/14g; g/14g 43419-320_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-320 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 100 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0098; .1014 mg/mL; mg/mL; mg/mL 43419-321_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-321 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 102 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0098; .1014 mg/mL; mg/mL; mg/mL 43419-322_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-322 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 104 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0098; .1014 mg/mL; mg/mL; mg/mL 43419-323_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-323 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 106 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0098; .1014 mg/mL; mg/mL; mg/mL 43419-324_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-324 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 200 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0098; .1014 mg/mL; mg/mL; mg/mL 43419-325_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-325 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 202 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0098; .1014 mg/mL; mg/mL; mg/mL 43419-326_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-326 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 204 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0098; .1014 mg/mL; mg/mL; mg/mL 43419-327_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-327 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 206 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0098; .1014 mg/mL; mg/mL; mg/mL 43419-330_f3df54e7-44b5-403a-ac57-a7d2030fc009 43419-330 HUMAN OTC DRUG IOPE BRIGHTGEN OXYBENZONE, OCTINOXATE, OCTISALATE, HOMOSALATE, OCTOCRYLENE, and TITANIUM DIOXIDE CREAM TOPICAL 20120824 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 3; 4.2; 2.7; 3; 2.7; 3.12 g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL 43419-339_0028cf3c-35f0-42c6-abca-1a6988527598 43419-339 HUMAN OTC DRUG IOPE B.B. SPF20/PA plus Octinoxate and TITANIUM DIOXIDE CREAM TOPICAL 20100801 OTC MONOGRAPH FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 2; 1.2 mL/40mL; mL/40mL 43419-340_edbcf755-9d78-4a14-a1c7-98ed41b5f9b4 43419-340 HUMAN OTC DRUG IOPE B.B BB OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120919 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 2; .996 g/40mL; g/40mL 43419-350_1ba09a09-268e-44db-8322-95d26e974e52 43419-350 HUMAN OTC DRUG IOPE UV Defense Sun Protector SPF 50plus AVOBENZONE, OCTISALATE, HOMOSALATE, and OCTOCRYLENE CREAM TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.8; 5.4; 2.7; 5.4 g/60mL; g/60mL; g/60mL; g/60mL 43419-351_54cef85b-90e2-4cfd-81bf-6ca4ebbbd028 43419-351 HUMAN OTC DRUG IOPE CC no. 1 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20141020 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; .8715; .686 g/35mL; g/35mL; g/35mL 43419-352_54cef85b-90e2-4cfd-81bf-6ca4ebbbd028 43419-352 HUMAN OTC DRUG IOPE CC no. 2 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20141020 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; .8715; .686 g/35mL; g/35mL; g/35mL 43419-353_d0b27b5a-417c-4c7b-be2a-428948a5e4dd 43419-353 HUMAN OTC DRUG IOPE Air Cushion Sunblock EX OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20100801 OTC MONOGRAPH FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.25; 2.94 g/30g; g/30g; g/30g 43419-354_537432ef-b52d-4770-955d-5c10a3b0099d 43419-354 HUMAN OTC DRUG IOPE S.S. CONDITIONING COLOR BASE No.40 SPF22 PA PLUS Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0439; .0098 mL/mL; mL/mL; mL/mL 43419-355_537432ef-b52d-4770-955d-5c10a3b0099d 43419-355 HUMAN OTC DRUG IOPE S.S. CONDITIONING COLOR BASE No.60 SPF22 PA PLUS Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0439; .0098 mL/mL; mL/mL; mL/mL 43419-356_896bd2e2-e57c-4ed0-9d82-396a7e4e3cd1 43419-356 HUMAN OTC DRUG IOPE SS CONDITIONING FOUNDATION NO.13 SPF22 PA PLUS Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .03; .01 mL/mL; mL/mL; mL/mL 43419-357_896bd2e2-e57c-4ed0-9d82-396a7e4e3cd1 43419-357 HUMAN OTC DRUG IOPE SS CONDITIONING FOUNDATION NO.21 SPF22 PA PLUS Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .03; .01 mL/mL; mL/mL; mL/mL 43419-358_896bd2e2-e57c-4ed0-9d82-396a7e4e3cd1 43419-358 HUMAN OTC DRUG IOPE SS CONDITIONING FOUNDATION NO.23 SPF22 PA PLUS Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .03; .01 mL/mL; mL/mL; mL/mL 43419-359_896bd2e2-e57c-4ed0-9d82-396a7e4e3cd1 43419-359 HUMAN OTC DRUG IOPE SS CONDITIONING FOUNDATION NO.31 SPF22 PA PLUS Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .03; .01 mL/mL; mL/mL; mL/mL 43419-360_0318c320-9a6c-4422-9b09-9d8308342631 43419-360 HUMAN OTC DRUG IOPE SS CONDITIONING TWINCAKE NO.13 SPF25 PA PLUS PLUS OCTINOXATE and ZINC OXIDE POWDER TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; ZINC OXIDE .06; .03 g/g; g/g 43419-361_0318c320-9a6c-4422-9b09-9d8308342631 43419-361 HUMAN OTC DRUG IOPE SS CONDITIONING TWINCAKE NO.21 SPF25 PA PLUS PLUS OCTINOXATE and ZINC OXIDE POWDER TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; ZINC OXIDE .06; .03 g/g; g/g 43419-362_0318c320-9a6c-4422-9b09-9d8308342631 43419-362 HUMAN OTC DRUG IOPE SS CONDITIONING TWINCAKE NO.23 SPF25 PA PLUS PLUS OCTINOXATE and ZINC OXIDE POWDER TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; ZINC OXIDE .06; .03 g/g; g/g 43419-363_0318c320-9a6c-4422-9b09-9d8308342631 43419-363 HUMAN OTC DRUG IOPE SS CONDITIONING TWINCAKE NO.31 SPF25 PA PLUS PLUS OCTINOXATE and ZINC OXIDE POWDER TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; ZINC OXIDE .06; .03 g/g; g/g 43419-367_9158dfc4-b723-4815-a56f-a6be47fb8909 43419-367 HUMAN OTC DRUG IOPE SUPER VITAL EXTRA MOIST B.B OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; .8715; .686 mL/35mL; mL/35mL; mL/35mL 43419-370_04641e32-dc2b-4345-8e1d-21bf4b36fd44 43419-370 HUMAN OTC DRUG IOPE SUPER VITAL EXTRA MOIST BASE TITANIUM DIOXIDE, OCTINOXATE, and ZINC OXIDE LOTION TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; .8715; .343 g/35mL; g/35mL; g/35mL 43419-371_9dc3748c-3c49-4ebe-9ad7-b29dabdeeb3f 43419-371 HUMAN OTC DRUG IOPE SUPER VITAL EXTRA MOIST FOUNDATION NO. 21 SPF12 PA PLUS TITANIUM DIOXIDE and OCTINOXATE LOTION TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 1.75; .287 g/35mL; g/35mL 43419-372_9dc3748c-3c49-4ebe-9ad7-b29dabdeeb3f 43419-372 HUMAN OTC DRUG IOPE SUPER VITAL EXTRA MOIST FOUNDATION NO. 23 SPF12 PA PLUS TITANIUM DIOXIDE and OCTINOXATE LOTION TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 1.75; .287 g/35mL; g/35mL 43419-373_45279514-2e53-43be-b9c0-96dea36c8140 43419-373 HUMAN OTC DRUG IOPE SUPER VITAL EXTRA MOIST TWIN PACT NO. 21 SPF25 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, AND ZINC OXIDE POWDER TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.08; 1.11744; .5292 g/18g; g/18g; g/18g 43419-374_45279514-2e53-43be-b9c0-96dea36c8140 43419-374 HUMAN OTC DRUG IOPE SUPER VITAL EXTRA MOIST TWIN PACT NO. 23 SPF25 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, AND ZINC OXIDE POWDER TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.08; 1.11744; .5292 g/18g; g/18g; g/18g 43419-380_4abd5f7b-2c87-4d1e-a1f2-83a02cee5574 43419-380 HUMAN OTC DRUG IOPE AIR CUSHION XP OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20130814 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-381_4abd5f7b-2c87-4d1e-a1f2-83a02cee5574 43419-381 HUMAN OTC DRUG IOPE AIR CUSHION XP OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20130814 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-382_9adc493e-5e87-4502-b10a-4491d37f4a6a 43419-382 HUMAN OTC DRUG IOPE AIR CUSHION XP COVER VANILLA BROAD SPECTRUM SPF50PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20130814 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-383_9adc493e-5e87-4502-b10a-4491d37f4a6a 43419-383 HUMAN OTC DRUG IOPE AIR CUSHION XP COVER BEIGE BROAD SPECTRUM SPF50PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20130814 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-384_d286e618-8b72-4491-9966-6473022ea291 43419-384 HUMAN OTC DRUG IOPE AIR CUSHION XP NATURAL 31 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20130612 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-385_bce1d73e-46f7-4035-8199-4e982834e95a 43419-385 HUMAN OTC DRUG IOPE Air Cushion Blusher no 1 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141027 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .63; .1494; .1764 g/9g; g/9g; g/9g 43419-386_bce1d73e-46f7-4035-8199-4e982834e95a 43419-386 HUMAN OTC DRUG IOPE Air Cushion Blusher no 2 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141027 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .63; .1494; .1764 g/9g; g/9g; g/9g 43419-398_ffedcffa-aac5-463c-b490-16343b139dc8 43419-398 HUMAN OTC DRUG IOPE MILD CLINIC SUN PROTECTOR TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20110516 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; ZINC OXIDE 2.22; 4.53 mL/60mL; mL/60mL 43419-501_248a1fcf-3edc-41ae-8cef-1872cd2c427b 43419-501 HUMAN OTC DRUG AMOREPACIFIC MOISTURE BOUND NO. 102 OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 2.5; 1.05 mL/50mL; mL/50mL 43419-502_248a1fcf-3edc-41ae-8cef-1872cd2c427b 43419-502 HUMAN OTC DRUG AMOREPACIFIC MOISTURE BOUND NO. 104 OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 2.5; 1.05 mL/50mL; mL/50mL 43419-503_248a1fcf-3edc-41ae-8cef-1872cd2c427b 43419-503 HUMAN OTC DRUG AMOREPACIFIC MOISTURE BOUND NO. 106 OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 2.5; 1.05 mL/50mL; mL/50mL 43419-504_248a1fcf-3edc-41ae-8cef-1872cd2c427b 43419-504 HUMAN OTC DRUG AMOREPACIFIC MOISTURE BOUND NO. 204 OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 2.5; 1.05 mL/50mL; mL/50mL 43419-505_a4a3b32c-42fa-472f-80a7-03e0c15b3503 43419-505 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE NO. 102 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.245; .294 mL/30mL; mL/30mL; mL/30mL 43419-506_a4a3b32c-42fa-472f-80a7-03e0c15b3503 43419-506 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE NO. 104 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.245; .294 mL/30mL; mL/30mL; mL/30mL 43419-507_a4a3b32c-42fa-472f-80a7-03e0c15b3503 43419-507 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE NO. 106 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.245; .294 mL/30mL; mL/30mL; mL/30mL 43419-508_a4a3b32c-42fa-472f-80a7-03e0c15b3503 43419-508 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE NO. 202 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.245; .294 mL/30mL; mL/30mL; mL/30mL 43419-509_a4a3b32c-42fa-472f-80a7-03e0c15b3503 43419-509 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE NO. 204 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.245; .294 mL/30mL; mL/30mL; mL/30mL 43419-510_a4a3b32c-42fa-472f-80a7-03e0c15b3503 43419-510 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE NO. 206 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.245; .294 mL/30mL; mL/30mL; mL/30mL 43419-511_609d1a43-dfc9-4816-aca0-596f3c623e6c 43419-511 HUMAN OTC DRUG AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20121205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-512_609d1a43-dfc9-4816-aca0-596f3c623e6c 43419-512 HUMAN OTC DRUG AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.106 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20121205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-513_609d1a43-dfc9-4816-aca0-596f3c623e6c 43419-513 HUMAN OTC DRUG AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.204 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20121205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-514_609d1a43-dfc9-4816-aca0-596f3c623e6c 43419-514 HUMAN OTC DRUG AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.208 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20121205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-515_bbc224e7-d0e5-417b-ae97-844cbbb591cb 43419-515 HUMAN OTC DRUG AMOREPACIFIC FUTURE RESPONSE Age Defense SPF30 OCTINOXATE, OCTISALATE, OCTOCRYLENE, and TITANIUM DIOXIDE CREAM TOPICAL 20130125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 3.6505; 2.34675; 4.172; 2.2946 g/50mL; g/50mL; g/50mL; g/50mL 43419-516_6ab34ca6-e83f-4247-bbed-ed10fe2a8694 43419-516 HUMAN OTC DRUG AMOREPACIFIC FUTURE RESPONSE AGE DEFENSE DUAL EYE WITH SPF 25 SUNSCREEN OCTINOXATE, OCTISALATE, OCTOCRYLENE, and TITANIUM DIOXIDE KIT 20140108 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC 43419-545_8c8a8d80-82c2-4f7b-9274-d07c8d71f73f 43419-545 HUMAN OTC DRUG Mamonde Total Mineral Moisture BB SPF20 PA plus OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 2.5; 1.5 mL/50mL; mL/50mL 43419-546_2d9d3750-5164-4eb8-b8a7-fa8b4735fb5d 43419-546 HUMAN OTC DRUG MAMONDE BRIGHTENING PACT 10HR N21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .032; .055; .02 g/g; g/g; g/g 43419-547_2d9d3750-5164-4eb8-b8a7-fa8b4735fb5d 43419-547 HUMAN OTC DRUG MAMONDE BRIGHTENING PACT 10HR N23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .032; .055; .02 g/g; g/g; g/g 43419-601_7d50297e-1f7e-44be-ae57-ad2a7570c2f0 43419-601 HUMAN OTC DRUG ETUDE HOUSE Precious Mineral BB Bright Fit Natural Beige W13 TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part352 ETUDE HOUSE TITANIUM DIOXIDE; ZINC OXIDE 6.264; .864 g/60g; g/60g 43419-602_7d50297e-1f7e-44be-ae57-ad2a7570c2f0 43419-602 HUMAN OTC DRUG ETUDE HOUSE Precious Mineral BB Bright Fit SPF 30 Honey Beige W24 TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part352 ETUDE HOUSE TITANIUM DIOXIDE; ZINC OXIDE 6.264; .864 g/60g; g/60g 43419-701_7aa57ff1-7e9b-422a-b5ce-df8102506a03 43419-701 HUMAN OTC DRUG LANEIGE LIP TREATMENT SPF 17 No.1 OCTINOXATE STICK TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE .12 g/4g 43419-702_7aa57ff1-7e9b-422a-b5ce-df8102506a03 43419-702 HUMAN OTC DRUG LANEIGE LIP TREATMENT SPF 17 No.2 OCTINOXATE STICK TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE .12 g/4g 43419-703_7aa57ff1-7e9b-422a-b5ce-df8102506a03 43419-703 HUMAN OTC DRUG LANEIGE LIP TREATMENT SPF 17 No.3 OCTINOXATE STICK TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE .12 g/4g 43419-704_ab48ca3d-966c-4e50-8173-ae335eb9c632 43419-704 HUMAN OTC DRUG LANEIGE BB Cushion Light OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-705_ab48ca3d-966c-4e50-8173-ae335eb9c632 43419-705 HUMAN OTC DRUG LANEIGE BB Cushion Medium OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-706_ab48ca3d-966c-4e50-8173-ae335eb9c632 43419-706 HUMAN OTC DRUG Laneige BB Cushion Dark OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-707_8e35813b-f397-47e6-b92f-f72b9bbf7777 43419-707 HUMAN OTC DRUG LANEIGE BB Cushion no.21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20140310 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-708_8e35813b-f397-47e6-b92f-f72b9bbf7777 43419-708 HUMAN OTC DRUG LANEIGE BB Cushion no.23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20140310 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-709_6d635814-5a57-48b0-9398-f9592b8bcabf 43419-709 HUMAN OTC DRUG LANEIGE Skin Veil Foundation EX No. 21N Natural Beige OCTINOXATE LOTION TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL 43419-710_6d635814-5a57-48b0-9398-f9592b8bcabf 43419-710 HUMAN OTC DRUG LANEIGE Skin Veil Foundation EX No. 23 Sand Beige OCTINOXATE LOTION TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL 43419-711_6d635814-5a57-48b0-9398-f9592b8bcabf 43419-711 HUMAN OTC DRUG LANEIGE Skin Veil Foundation EX No. 31 Brown Beige OCTINOXATE LOTION TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL 43419-712_102d2cba-3484-4133-b6eb-bff324002d93 43419-712 HUMAN OTC DRUG LANEIGE SKIN VEIL BASE EX No.40 Light Purple OCTINOXATE LOTION TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL 43419-713_102d2cba-3484-4133-b6eb-bff324002d93 43419-713 HUMAN OTC DRUG LANEIGE SKIN VEIL BASE EX No.60 Light Green OCTINOXATE LOTION TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL 43419-714_4536c1c6-d397-4a3b-8907-7d1b8da640d5 43419-714 HUMAN OTC DRUG Sulwhasoo Lumitouch Multi-Base No.1 Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.65; 2.94 mL/30mL; mL/30mL; mL/30mL 43419-715_4536c1c6-d397-4a3b-8907-7d1b8da640d5 43419-715 HUMAN OTC DRUG Sulwhasoo Lumitouch Multi-Base No.2 Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.65; 2.94 mL/30mL; mL/30mL; mL/30mL 43419-716_f4464483-1b9f-4b9a-ab2f-3001b26cf5b7 43419-716 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation SPF15, PA plus OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100901 OTC MONOGRAPH FINAL part352 AMOREPACIFIC CO. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; 2.584; .2939 mL/30mL; mL/30mL; mL/30mL 43419-717_b0cc649f-c625-4272-913c-705d779a99f5 43419-717 HUMAN OTC DRUG Sulwhasoo Lumitouch Base Makeup SPF15, PA plus OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100901 OTC MONOGRAPH FINAL part352 AMOREPACIFIC CO. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .82; .294 mL/30mL; mL/30mL; mL/30mL 43419-718_0dff6226-0138-4049-b413-883588a5a13d 43419-718 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation SPF26, PA plus plus OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100901 OTC MONOGRAPH FINAL part352 AMOREPACIFIC CO. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .56; 3.358; 1.371 g/14g; g/14g; g/14g 43419-719_ccfe56ff-4382-4b3e-8fdb-3c9650473823 43419-719 HUMAN OTC DRUG Sulwhasoo Lumitouch Twincake SPF25, PA plus plus OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20100901 OTC MONOGRAPH FINAL part352 AMOREPACIFIC CO. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .352; 1.533; .216 g/11g; g/11g; g/11g 43419-721_27387f1a-989b-4ec5-bda3-ab8569f8b8c5 43419-721 HUMAN OTC DRUG Laneige Watery Cushion Concealer no. 1 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141021 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 125; 50; 49 mg/2.5mL; mg/2.5mL; mg/2.5mL 43419-722_27387f1a-989b-4ec5-bda3-ab8569f8b8c5 43419-722 HUMAN OTC DRUG Laneige Watery Cushion Concealer no. 2 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141021 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 125; 50; 49 mg/2.5mL; mg/2.5mL; mg/2.5mL 43419-723_27387f1a-989b-4ec5-bda3-ab8569f8b8c5 43419-723 HUMAN OTC DRUG Laneige Watery Cushion Concealer no. 3 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141021 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 125; 50; 49 mg/2.5mL; mg/2.5mL; mg/2.5mL 43419-724_0ff8da51-47ac-464c-8c14-1431c19430f8 43419-724 HUMAN OTC DRUG Laneige Cushion Concealer Light OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 125; 62.25; 49 mg/2.5mL; mg/2.5mL; mg/2.5mL 43419-725_3f060970-bb10-4520-bbed-6356213b79b4 43419-725 HUMAN OTC DRUG Laneige Cushion Concealer Medium OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 125; 62.25; 49 mg/2.5mL; mg/2.5mL; mg/2.5mL 43419-726_f5464fd7-e784-45e3-b656-fccd4f6ff58d 43419-726 HUMAN OTC DRUG LANEIGE Forever Definite Compact Foundation No.1 TITANIUM DIOXIDE and ZINC OXIDE POWDER TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; ZINC OXIDE .8379; .2646 g/9g; g/9g 43419-727_f5464fd7-e784-45e3-b656-fccd4f6ff58d 43419-727 HUMAN OTC DRUG LANEIGE Forever Definite Compact Foundation No.2 TITANIUM DIOXIDE and ZINC OXIDE POWDER TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; ZINC OXIDE .8379; .2646 g/9g; g/9g 43419-728_f5464fd7-e784-45e3-b656-fccd4f6ff58d 43419-728 HUMAN OTC DRUG LANEIGE Forever Definite Compact Foundation No.3 TITANIUM DIOXIDE and ZINC OXIDE POWDER TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; ZINC OXIDE .8379; .2646 g/9g; g/9g 43419-729_f5464fd7-e784-45e3-b656-fccd4f6ff58d 43419-729 HUMAN OTC DRUG LANEIGE Forever Definite Compact Foundation No.4 TITANIUM DIOXIDE and ZINC OXIDE POWDER TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; ZINC OXIDE .8379; .2646 g/9g; g/9g 43419-730_c3bfec20-de78-4f51-b414-3e7f8a67b520 43419-730 HUMAN OTC DRUG LANEIGE Snow BB No.1 Brightening BB OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 2.324; .784 g/40mL; g/40mL; g/40mL 43419-731_c3bfec20-de78-4f51-b414-3e7f8a67b520 43419-731 HUMAN OTC DRUG LANEIGE Snow BB No.2 Natural BB OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 2.324; .784 g/40mL; g/40mL; g/40mL 43419-733_ab48ca3d-966c-4e50-8173-ae335eb9c632 43419-733 HUMAN OTC DRUG Laneige BB Cushion Medium Dark OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g 43419-744_a5fd9a8b-efdd-47a0-bc24-4c64abf84357 43419-744 HUMAN OTC DRUG LANEIGE MYSTIC VEIL FOUNDATION No. 21 Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.25; 1.70426; .49 mL/25mL; mL/25mL; mL/25mL 43419-745_a5fd9a8b-efdd-47a0-bc24-4c64abf84357 43419-745 HUMAN OTC DRUG LANEIGE MYSTIC VEIL FOUNDATION No. 23 Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.25; 1.70426; .49 mL/25mL; mL/25mL; mL/25mL 43419-746_392dd6e2-7407-4946-994d-a419737f9e14 43419-746 HUMAN OTC DRUG Laneige Sliding Pact EX snow crystal No.1 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111221 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .72; .74496; .3528 g/12g; g/12g; g/12g 43419-747_392dd6e2-7407-4946-994d-a419737f9e14 43419-747 HUMAN OTC DRUG Laneige sliding pact EX snow crystal No.2 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111221 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .72; .74496; .3528 g/12g; g/12g; g/12g 43419-748_392dd6e2-7407-4946-994d-a419737f9e14 43419-748 HUMAN OTC DRUG Laneige sliding pact EX snow crystal No.3 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111221 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .72; .74496; .3528 g/12g; g/12g; g/12g 43419-749_392dd6e2-7407-4946-994d-a419737f9e14 43419-749 HUMAN OTC DRUG Laneige sliding pact EX snow crystal No.4 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111221 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .72; .74496; .3528 g/12g; g/12g; g/12g 43419-750_392dd6e2-7407-4946-994d-a419737f9e14 43419-750 HUMAN OTC DRUG Laneige sliding pact EX snow crystal No.5 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111221 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .72; .74496; .3528 g/12g; g/12g; g/12g 43419-765_cba8b903-850f-4160-a396-67c8cec8bc2d 43419-765 HUMAN OTC DRUG Laneige Triple Sunscreen AVOBENZONE, OCTISALATE, HOMOSALATE, and OCTOCRYLENE CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1500; 4500; 2250; 4500 mg/50mL; mg/50mL; mg/50mL; mg/50mL 43419-801_239f6a22-a845-4aad-a1a1-f34e1ba390cc 43419-801 HUMAN OTC DRUG Mamonde Total Moisture BB 01 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2; .996; .784 g/40mL; g/40mL; g/40mL 43419-802_239f6a22-a845-4aad-a1a1-f34e1ba390cc 43419-802 HUMAN OTC DRUG Mamonde Total Moisture BB 02 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2; .996; .784 g/40mL; g/40mL; g/40mL 43419-803_d696898b-3844-4c8b-8bac-07181178bb4a 43419-803 HUMAN OTC DRUG MAMONDE PACT BLOOMING 21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20130930 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .384; .51216; .2352 g/12g; g/12g; g/12g 43419-804_d696898b-3844-4c8b-8bac-07181178bb4a 43419-804 HUMAN OTC DRUG MAMONDE PACT BLOOMING 23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20130930 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .384; .51216; .2352 g/12g; g/12g; g/12g 43419-811_725711cf-9695-425c-b6f1-e892bea63e00 43419-811 HUMAN OTC DRUG LANEIGE SunScreen Triple OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 58.1; 19.6 mg/mL; mg/mL; g/mL 43419-850_2b702ef4-ae8f-4043-902d-70d6a91717f2 43419-850 HUMAN OTC DRUG LANEIGE SKIN VEIL BASE NO. 20 SPF 26 PA PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .037; .012 mg/mL; mg/mL; mg/mL 43419-851_2b702ef4-ae8f-4043-902d-70d6a91717f2 43419-851 HUMAN OTC DRUG LANEIGE SKIN VEIL BASE NO. 40 SPF 26 PA PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .037; .012 mg/mL; mg/mL; mg/mL 43419-852_7cb0ea13-db9b-4986-94dd-b086e2e5ee89 43419-852 HUMAN OTC DRUG LANEIGE SKIN VEIL BASE SPF 26 PA plus Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100901 OTC MONOGRAPH FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.11; .36 mL/30mL; mL/30mL; mL/30mL 43419-853_9d982d2c-428c-49ef-a195-3816bfe252dc 43419-853 HUMAN OTC DRUG Laneige Skin Veil NO.21 SPF 26 PAplus OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0955; .012 mg/mL; mg/mL; mg/mL 43419-854_9d982d2c-428c-49ef-a195-3816bfe252dc 43419-854 HUMAN OTC DRUG Laneige Skin Veil NO.23 SPF 26 PAplus OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0955; .012 mg/mL; mg/mL; mg/mL 43419-855_9d982d2c-428c-49ef-a195-3816bfe252dc 43419-855 HUMAN OTC DRUG Laneige Skin Veil NO.31 SPF 26 PAplus OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0955; .012 mg/mL; mg/mL; mg/mL 43419-856_9d982d2c-428c-49ef-a195-3816bfe252dc 43419-856 HUMAN OTC DRUG Laneige Skin Veil NO.33 SPF 26 PAplus OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0955; .012 mg/mL; mg/mL; mg/mL 43419-857_05ba4362-a6e2-4aca-858d-b691cfcb143a 43419-857 HUMAN OTC DRUG LANEIGE SNOW CRYSTAL No. 21 SPF22 PAplus Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0582; .0098 mg/mL; mg/mL; mg/mL 43419-858_05ba4362-a6e2-4aca-858d-b691cfcb143a 43419-858 HUMAN OTC DRUG LANEIGE SNOW CRYSTAL No. 23 SPF22 PAplus Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0582; .0098 mg/mL; mg/mL; mg/mL 43419-859_05ba4362-a6e2-4aca-858d-b691cfcb143a 43419-859 HUMAN OTC DRUG LANEIGE SNOW CRYSTAL No. 31 SPF22 PAplus Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0582; .0098 mg/mL; mg/mL; mg/mL 43419-860_05ba4362-a6e2-4aca-858d-b691cfcb143a 43419-860 HUMAN OTC DRUG LANEIGE SNOW CRYSTAL No. 33 SPF22 PAplus Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0582; .0098 mg/mL; mg/mL; mg/mL 43419-861_1b0a97ed-7a21-4bfb-97ae-dd640b276e9a 43419-861 HUMAN OTC DRUG Laneige UV TOTAL BASE Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .07; .084; .02 mg/mL; mg/mL; mg/mL 43419-862_1b0a97ed-7a21-4bfb-97ae-dd640b276e9a 43419-862 HUMAN OTC DRUG Laneige UV TOTAL BASE Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .07; .084; .02 mg/mL; mg/mL; mg/mL 43419-863_2a43db72-7e0f-4bf2-b9e4-81ef73a2f989 43419-863 HUMAN OTC DRUG LANEIGE SATIN FINISH TWIN PACT NO. 13 TITANIUM DIOXIDE, OCTINOXATE, and ZINC OXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .06; .08; .0294 mg/g; mg/g; mg/g 43419-864_2a43db72-7e0f-4bf2-b9e4-81ef73a2f989 43419-864 HUMAN OTC DRUG LANEIGE SATIN FINISH TWIN PACT NO. 21 TITANIUM DIOXIDE, OCTINOXATE, and ZINC OXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .06; .08; .0294 mg/g; mg/g; mg/g 43419-865_2a43db72-7e0f-4bf2-b9e4-81ef73a2f989 43419-865 HUMAN OTC DRUG LANEIGE SATIN FINISH TWIN PACT NO. 23 TITANIUM DIOXIDE, OCTINOXATE, and ZINC OXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .06; .08; .0294 mg/g; mg/g; mg/g 43419-866_2a43db72-7e0f-4bf2-b9e4-81ef73a2f989 43419-866 HUMAN OTC DRUG LANEIGE SATIN FINISH TWIN PACT NO. 25 TITANIUM DIOXIDE, OCTINOXATE, and ZINC OXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .06; .08; .0294 mg/g; mg/g; mg/g 43419-867_2a43db72-7e0f-4bf2-b9e4-81ef73a2f989 43419-867 HUMAN OTC DRUG LANEIGE SATIN FINISH TWIN PACT NO. 31 TITANIUM DIOXIDE, OCTINOXATE, and ZINC OXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .06; .08; .0294 mg/g; mg/g; mg/g 43419-901_bf4c0f3c-2f14-49fb-88a6-5be78b2dea50 43419-901 HUMAN OTC DRUG SONGYUM New Pinesalt SODIUM FLUORIDE PASTE DENTAL 20130305 OTC MONOGRAPH NOT FINAL part355 AMOREPACIFIC SODIUM FLUORIDE .198 g/90g 43419-902_313de4c6-5e5d-4376-ba5e-b8f49d2ad619 43419-902 HUMAN OTC DRUG MEDIAN New Marine fluoride SODIUM FLUORIDE PASTE DENTAL 20130305 OTC MONOGRAPH NOT FINAL part355 AMOREPACIFIC SODIUM FLUORIDE .198 g/90g 43419-903_ccebb021-c38f-415c-b000-af8083e9802f 43419-903 HUMAN OTC DRUG MEDIAN New Forest SODIUM FLUORIDE PASTE DENTAL 20130305 OTC MONOGRAPH NOT FINAL part355 AMOREPACIFIC SODIUM FLUORIDE .198 g/90g 43438-003_afbde6f2-25d3-4898-9435-02cbf8f1aa69 43438-003 HUMAN OTC DRUG Iman Skin Tone Evener BB SPF 15 OXYBENZONE CREAM TOPICAL 20120816 OTC MONOGRAPH NOT FINAL part352 Impala, Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100mL; g/100mL 43447-2071_85994524-8b8e-489b-94ae-8c4ca6f02a10 43447-2071 HUMAN OTC DRUG SKIN SAKE PETROLATUM OINTMENT TOPICAL 20051201 OTC MONOGRAPH FINAL part346 Skin Sake, LLC PETROLATUM 23 g/71g 43447-4410_873bd880-3d3e-4e85-a9d6-9fd0c6a9dcbf 43447-4410 HUMAN OTC DRUG SKIN SAKE Surface Protectant DIMETHICONE OINTMENT TOPICAL 20091001 OTC MONOGRAPH FINAL part347 Skin Sake, LLC DIMETHICONE 2.272 g/113.6g 43447-9440_332ac550-5435-45b1-83b3-f8d7c0c43792 43447-9440 HUMAN OTC DRUG Booty Goo ZINC OXIDE OINTMENT TOPICAL 20051201 OTC MONOGRAPH FINAL part346 Skin Sake, LLC ZINC OXIDE 17.75 g/71g 43455-0001_c028cd57-f5e6-4dc6-9640-bee5283e1051 43455-0001 HUMAN OTC DRUG LBEL DEFENSE 365 Daily Protective Facial SPF 50 HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20120328 OTC MONOGRAPH FINAL part352 Ventura International, LTD HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 5; 7; 5; 4; 6.24; 3.92 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 43455-0002_5fa42a37-7be9-4e1f-a4c2-a33d92e085b2 43455-0002 HUMAN OTC DRUG LBEL HYDRA CALME SPF 15 Intensive Moisturizing Facial OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20120325 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 4 mL/100mL; mL/100mL; mL/100mL 43455-0003_8dfa0764-2694-4030-9ad5-d5fcbbfecc86 43455-0003 HUMAN OTC DRUG LBEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Normal to Combination Skin OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20120328 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 4 mL/100mL; mL/100mL; mL/100mL 43455-0004_a1740037-6944-4a4e-a6ef-1b9744c62980 43455-0004 HUMAN OTC DRUG LBEL RENOVANCE JOUR Daytime Face SPF 15 All Skin Types OCTINOXATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20120328 OTC MONOGRAPH FINAL part352 VENTURA INTERNATIONAL LTD. OCTINOXATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 3 g/100g; g/100g; g/100g 43455-0005_e4fa477d-b315-4e58-a5a9-613f83d0d17a 43455-0005 HUMAN OTC DRUG LBEL SUPREMACIE NX JOUR Replenishing Treatment Daytime Face SPF 15 Normal To Dry Skin ENSULIZOLE, HOMOSALATE, OCTINOXATE, OXYBENZONE CREAM TOPICAL 20120328 OTC MONOGRAPH FINAL part352 Ventura International, LTD ENSULIZOLE; HOMOSALATE; OCTINOXATE; OXYBENZONE 2; 2; 7.5; 4 g/100g; g/100g; g/100g; g/100g 43455-0006_6e18aae4-b862-4dfb-8f40-a8d42f08384f 43455-0006 HUMAN OTC DRUG LBEL SUPREMACIE NX JOUR Replenishing Treatment Daytime Face SPF 15 Normal To Oily Skin ENSULIZOLE, HOMOSALATE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20120328 OTC MONOGRAPH FINAL part352 Ventura International, LTD ENSULIZOLE; HOMOSALATE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 1.5; 1; 7.5; 4.5; 1.17 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 43455-0007_a273e9ea-b57b-4711-ab6a-7574362ef54e 43455-0007 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - CLAIRE 1 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43455-0008_49be8601-dfc3-4220-b3a0-8431a8d0c49a 43455-0008 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - CLAIRE 2 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43455-0009_ed7272a9-0e47-4b10-a877-673ba69769a8 43455-0009 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - CLAIRE 3 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43455-0010_4afadbdd-7f78-43f5-a4ce-a5168a55473a 43455-0010 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - CLAIRE 4 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43455-0011_fc65c644-236a-4b13-bcce-ef627d970bfb 43455-0011 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 5 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43455-0012_4fa6b1e5-243e-431c-9ac3-f15d0898bc9f 43455-0012 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 6 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43455-0013_7b125d9a-b38f-4551-aaff-fc1b95518472 43455-0013 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 7 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43455-0014_7e04ab31-6ea1-4b98-a02b-00a51a82a2ce 43455-0014 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 8 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43455-0015_79720c93-6a6b-4588-99c3-7675e332067f 43455-0015 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 6A OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43455-0016_14eb5f64-af0d-4067-9298-6445bf5a70d5 43455-0016 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 6B OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43455-0017_2a2a128b-b526-418b-9a24-542f51371c98 43455-0017 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 8A OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43455-0018_e9ca985e-9902-4c13-bd5c-8057de4b688b 43455-0018 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 8B OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43455-0019_020470c6-f822-4885-9a1a-034a22210a84 43455-0019 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 8C OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43455-0020_7ac77d74-ac4c-4197-a91b-fd2d4925764b 43455-0020 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 10 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43458-1002_ef56b8ff-f859-4500-80b4-dcd68dbc309d 43458-1002 HUMAN OTC DRUG Vertra SPF 35 Foundation Sunscreen Face Natural Beige TITANIUM DIOXIDE STICK TOPICAL 20120708 OTC MONOGRAPH FINAL part352 Vertra, Inc TITANIUM DIOXIDE 24.15 g/100g 43458-1003_8a1c3e2f-7dae-490b-b7a0-3c973194464d 43458-1003 HUMAN OTC DRUG Vertra SPF 50 Foundation Sunscreen Face Translucent TITANIUM DIOXIDE, PADIMATE O STICK TOPICAL 20120708 OTC MONOGRAPH FINAL part352 Vertra, Inc PADIMATE O; TITANIUM DIOXIDE 7; 17.4 g/100g; g/100g 43458-1004_99d36af8-7195-477b-ac5a-0e2b8d67d25b 43458-1004 HUMAN OTC DRUG Vertra SPF 38 Foundation Sunscreen Face Kona Gold Shane Dorian Signature Tint TITANIUM DIOXIDE STICK TOPICAL 20120708 OTC MONOGRAPH FINAL part352 Vertra, Inc TITANIUM DIOXIDE 24.15 g/100g 43458-1005_f4780509-7355-4f12-b482-a7c8f213e491 43458-1005 HUMAN OTC DRUG Vertra Elemental Resistance Mick Fanning Signature SPF 28 OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE STICK TOPICAL 20120308 OTC MONOGRAPH FINAL part352 Vertra, Inc OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 5; 5; 3 g/100g; g/100g; g/100g 43459-0152_9b0c0db2-168f-45b3-a2ce-b9204dcccd32 43459-0152 HUMAN OTC DRUG Non-Aspirin Acetaminophen TABLET ORAL 20100715 OTC MONOGRAPH NOT FINAL part343 Etex Pharm Co., Ltd ACETAMINOPHEN 500 mg/1 43459-0153_9b0c0db2-168f-45b3-a2ce-b9204dcccd32 43459-0153 HUMAN OTC DRUG Non-Aspirin Acetaminophen TABLET ORAL 20100801 OTC MONOGRAPH NOT FINAL part343 Etex Pharm Co., Ltd ACETAMINOPHEN 500 mg/1 43469-864_f58663b2-519f-4c74-9e04-8431dab711a9 43469-864 HUMAN PRESCRIPTION DRUG Synera lidocaine and tetracaine PATCH CUTANEOUS 20050623 NDA NDA021623 ZARS Pharma, Inc. LIDOCAINE; TETRACAINE 70; 70 mg/1; mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 43473-308_ed0cf1bd-515d-43ad-b956-114a34cc5fff 43473-308 HUMAN OTC DRUG Health and Beyond Green ALCOHOL LIQUID TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part333A Nantong Health & Beyond Hygienic Products Inc ALCOHOL .3 mL/mL 43473-801_d89bd7b2-da00-4991-8c17-4274d4b11126 43473-801 HUMAN OTC DRUG Health and Beyond Antiseptic Hand Sanitizer ETHYL ALCOHOL SPRAY TOPICAL 20120520 OTC MONOGRAPH NOT FINAL part333E Nantong Health & Beyond Hygienic Products Inc. ALCOHOL 62 mL/100mL 43473-802_cb735c02-94db-4a62-b357-3980d4058171 43473-802 HUMAN OTC DRUG Health And Beyond Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part333E Nantong Health & Beyond Hygienic Products Inc. ALCOHOL 62 mL/100mL 43473-803_60641f19-0187-4525-843e-a501a2950e83 43473-803 HUMAN OTC DRUG Health And Beyond Instant Hand Sanitizer Twin Pack Twin Pack ETHYL ALCOHOL KIT TOPICAL 20140627 OTC MONOGRAPH NOT FINAL part333E Nantong Health & Beyond Hygienic Products Inc. 43473-805_201e506e-c0e9-4431-9c52-9a6d67a59a05 43473-805 HUMAN OTC DRUG ALCOHOL ALCOHOL GEL TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part333A Nantong Health & Beyond Hygienic Products Inc. ALCOHOL 65 mL/100mL 43473-806_94f1019d-e87b-4af1-b2d0-f4b98fe7b849 43473-806 HUMAN OTC DRUG Health And Beyond Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20141215 OTC MONOGRAPH NOT FINAL part333E Nantong Health & Beyond Hygienic Products Inc. ALCOHOL 62 mL/100mL 43473-807_63dc8301-235b-446c-9d29-cfb69716f1b6 43473-807 HUMAN OTC DRUG Health And Beyond Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20141215 OTC MONOGRAPH NOT FINAL part333E Nantong Health & Beyond Hygienic Products Inc. ALCOHOL 62 mL/100mL 43474-000_98ee4d74-8e11-41e3-ad0c-0a7f089b3725 43474-000 HUMAN OTC DRUG bioCorneum HC Advanced Scar Supervision Anti-Itch HYDROCORTISONE ACETATE GEL TOPICAL 20120510 OTC MONOGRAPH FINAL part348 Enaltus Inc HYDROCORTISONE ACETATE 1 g/100g 43474-001_e22951c5-cacf-47cb-9bb3-f722520a33e7 43474-001 HUMAN OTC DRUG bioCorneum plus SPF 30 advanced SCAR SUPERVISION OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE GEL TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Enaltus Inc OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 10; 6 g/100g; g/100g; g/100g; g/100g 43478-241_f83179df-0c02-4c24-8965-abf1152d9a6d 43478-241 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin CREAM TOPICAL 19981224 ANDA ANDA075213 Rouses Point Pharm TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 43478-242_f83179df-0c02-4c24-8965-abf1152d9a6d 43478-242 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin CREAM TOPICAL 19981224 ANDA ANDA075265 Rouses Point Pharm TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 43478-243_f83179df-0c02-4c24-8965-abf1152d9a6d 43478-243 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin CREAM TOPICAL 19981224 ANDA ANDA075264 Rouses Point Pharm TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 43478-244_f83179df-0c02-4c24-8965-abf1152d9a6d 43478-244 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin GEL TOPICAL 20000222 ANDA ANDA075529 Rouses Point Pharm TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 43478-245_f83179df-0c02-4c24-8965-abf1152d9a6d 43478-245 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin GEL TOPICAL 20020611 ANDA ANDA075589 Rouses Point Pharm TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 43478-270_5eb76f64-10dd-40ec-a91e-f1b4f80bb476 43478-270 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate hydrocortisone butyrate CREAM TOPICAL 20090901 NDA NDA018514 Rouses Point Pharm HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43478-271_0be56142-8478-4a0e-b702-a77412017f03 43478-271 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate hydrocortisone butyrate OINTMENT TOPICAL 20090901 NDA NDA018652 Rouses Point Pharm HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43478-273_1bbd0fdc-16f7-4afa-bb53-ae2f904127b3 43478-273 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate hydrocortisone butyrate SOLUTION TOPICAL 20100224 NDA NDA019116 Rouses Point Pharm HYDROCORTISONE BUTYRATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43478-410_7b69a75a-8851-4f4d-b827-009fcbdbac95 43478-410 HUMAN PRESCRIPTION DRUG Nitroglycerin nitroglycerin AEROSOL, METERED SUBLINGUAL 20121016 NDA AUTHORIZED GENERIC NDA021780 Rouses Point Pharm NITROGLYCERIN 400 ug/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 43478-900_685b6bbf-9137-40a8-ba3f-56ba143d20ee 43478-900 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19830419 NDA AUTHORIZED GENERIC NDA018553 Rouses Point Pharm PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43478-901_685b6bbf-9137-40a8-ba3f-56ba143d20ee 43478-901 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19830419 NDA AUTHORIZED GENERIC NDA018553 Rouses Point Pharm PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43478-902_685b6bbf-9137-40a8-ba3f-56ba143d20ee 43478-902 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19830419 NDA AUTHORIZED GENERIC NDA018553 Rouses Point Pharm PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43478-903_685b6bbf-9137-40a8-ba3f-56ba143d20ee 43478-903 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19830419 NDA AUTHORIZED GENERIC NDA018553 Rouses Point Pharm PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 43479-103_a100dade-e063-4099-8c1b-4f9da7341b98 43479-103 HUMAN OTC DRUG EXFOLIKATE ACNE SALICYLIC ACID GEL TOPICAL 20140622 OTC MONOGRAPH FINAL part333D KATE SOMERVILLE SKINCARE, LLC SALICYLIC ACID .5 g/100mL 43479-105_9fddca10-e180-41f5-97d6-a104eff97716 43479-105 HUMAN OTC DRUG ANTI BAC ACNE CLEARING BENZOYL PEROXIDE LOTION TOPICAL 20140622 OTC MONOGRAPH FINAL part333D KATE SOMERVILLE SKINCARE, LLC BENZOYL PEROXIDE 5 g/100mL 43479-106_fbd213f2-c64f-4c0c-bf40-1ed89cf65ec6 43479-106 HUMAN OTC DRUG EradiKate ACNE TREATMENT SULFUR LIQUID TOPICAL 20140615 OTC MONOGRAPH FINAL part333D Kate Somerville Skincare, LLC SULFUR 10 g/100mL 43479-107_318d3729-3106-416d-9075-f7e152747c3f 43479-107 HUMAN OTC DRUG HYDRACLEAR HYDRATING ACNE GEL SALICYLIC ACID GEL TOPICAL 20140622 OTC MONOGRAPH FINAL part333D KATE SOMERVILLE SKINCARE, LLC SALICYLIC ACID .5 g/100mL 43479-108_9632f63c-e700-4191-b08e-d39e4d0c0073 43479-108 HUMAN OTC DRUG DERMAL QUENCH CLEAR ANTI-ACNE TREATMENT SALICYLIC ACID GEL TOPICAL 20140622 OTC MONOGRAPH FINAL part333D KATE SOMERVILLE SKINCARE, LLC SALICYLIC ACID .5 g/100mL 43479-109_28882755-2df3-42f6-8a6b-db8d20a49233 43479-109 HUMAN OTC DRUG EradiKate Facial Mask SULFUR LOTION TOPICAL 20140615 OTC MONOGRAPH FINAL part333D Kate Somerville Skincare, LLC SULFUR 5 g/100mL 43479-201_b11e376b-7b56-4f62-a1e7-0354fdfe4eae 43479-201 HUMAN OTC DRUG Daily Deflector Waterlight SPF 50 TITANIUM DIOXIDE, ZINC OXIDE LIQUID TOPICAL 20140622 OTC MONOGRAPH NOT FINAL part352 KATE SOMERVILLE SKINCARE LLC TITANIUM DIOXIDE; ZINC OXIDE 8.3; 12.6 g/100mL; g/100mL 43479-202_c91d8289-0d1a-4b51-b57f-6c097b4b372b 43479-202 HUMAN OTC DRUG DAILY DEFLECTOR MOISTURIZER SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20140622 OTC MONOGRAPH FINAL part352 KATE SOMERVILLE SKINCARE, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 43479-203_26e88124-b6be-4b75-b079-2738ec45cab4 43479-203 HUMAN OTC DRUG DAILY DEFLECTOR MOISTURIZER SPF 20 OCTINOXATE, AVOBENZONE, OXYBENZONE LOTION TOPICAL 20140622 OTC MONOGRAPH FINAL part352 KATE SOMERVILLE SKINCARE, LLC AVOBENZONE; OCTINOXATE; OXYBENZONE 3; 7.5; 4 g/100mL; g/100mL; g/100mL 43479-204_180cf153-e1dc-4763-a593-2b08f33d9557 43479-204 HUMAN OTC DRUG ILLUMIKATE CC CREAM SPF 50 OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20140618 OTC MONOGRAPH FINAL part352 KATE SOMERVILLE SKINCARE, LLC OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 5; 3; 6.6 g/100mL; g/100mL; g/100mL; g/100mL 43479-205_972eed51-145e-46a4-881d-022c23ca981e 43479-205 HUMAN OTC DRUG BODY GLOW SUNSCREEN SPF 20 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20140622 OTC MONOGRAPH FINAL part352 KATE SOMERVILLE SKINCARE, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.5; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 43479-301_10fd8bfc-4c85-4b69-9884-2a7354345c1f 43479-301 HUMAN OTC DRUG ECZEMA THERAPY OATMEAL CREAM TOPICAL 20140618 OTC MONOGRAPH FINAL part347 KATE SOMERVILLE SKINCARE, LLC OATMEAL 1 g/100mL 43479-501_3b202664-379c-4b6d-805b-ecbcab901c3c 43479-501 HUMAN OTC DRUG 24 HOUR PIMPLE PUNISHER SALICYLIC ACID KIT 20140622 OTC MONOGRAPH FINAL part333D KATE SOMERVILLE SKINCARE, LLC 43482-1728_8d5419c0-996b-4d0e-af63-fbc6b84f7581 43482-1728 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20080603 UNAPPROVED MEDICAL GAS Reliable Medical Inc. OXYGEN 99 L/100L 43489-100_04392bd3-ee68-4cdc-82c0-41df1d096c93 43489-100 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110415 ANDA ANDA090752 Secan Pharmaceuticals Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 43489-101_04392bd3-ee68-4cdc-82c0-41df1d096c93 43489-101 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110415 ANDA ANDA090752 Secan Pharmaceuticals Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 43492-0001_92851e70-4330-4122-84e0-b96c6f77f666 43492-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20080720 UNAPPROVED MEDICAL GAS Scheffe RX Inc OXYGEN 99 L/100L 43493-0001_452914d5-bba7-4497-a230-951c541ce99b 43493-0001 HUMAN OTC DRUG Pain Relief Rub Iampur Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part348 Avaria Health & Beauty Corp CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 4; 4; 11 g/100g; g/100g; g/100g 43493-0002_26361049-6743-491c-b895-3f931e5b0f10 43493-0002 HUMAN OTC DRUG Pain Relieving Iampur Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part348 Avaria Health & Beauty Corp CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 4; 4; 11 g/g; g/g; g/g 43498-100_c4e42882-0b98-4a1b-a7e8-ea6fa4b7228d 43498-100 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g 43498-101_519f757a-827f-4587-afbc-ca5a53961b10 43498-101 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g 43498-102_0d945505-996a-4fab-ae42-7c5f1c494ea7 43498-102 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g 43498-103_3b23a7c4-3289-48d3-8dfc-f1d7849ba4c3 43498-103 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g 43498-104_7e5a146b-2428-4037-98d0-02a750b9d8c1 43498-104 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g 43498-105_a881561f-c658-4fad-81ac-be2f9a23558a 43498-105 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g 43498-106_1c99bd3c-bd8b-45ce-ba37-21bf4cf7b1e5 43498-106 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g 43498-107_a9414cfe-2c2e-4794-9de8-fc1975f01e40 43498-107 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g 43498-108_ea4e5bdc-277c-4b1e-a57c-fa06ab987527 43498-108 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g 43498-109_b5e0a71a-2f8b-4f20-a1ec-5f554aad9969 43498-109 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g 43498-150_920f64a9-0748-491f-8bd0-f59c29dbb1a9 43498-150 HUMAN PRESCRIPTION DRUG Burkhart Neutral pH Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 4.086 g/454g 43498-151_5659c4ae-75b3-4949-8583-eeb7112d1f76 43498-151 HUMAN PRESCRIPTION DRUG Burkhart Neutral pH Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 4.086 g/454g 43498-200_3249158a-0846-4683-87c4-c8682da69f83 43498-200 HUMAN PRESCRIPTION DRUG Burkhart Stannous Fluoride CONCENTRATE DENTAL 20130201 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc STANNOUS FLUORIDE .3408 g/284g 43498-201_c19f2b09-b71c-4b8a-b7ef-0ba8784140c6 43498-201 HUMAN PRESCRIPTION DRUG Burkhart Stannous Fluoride CONCENTRATE DENTAL 20130201 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc STANNOUS FLUORIDE .3408 g/284g 43498-250_447fcd37-bb4b-4549-a356-d21fc33b00c3 43498-250 HUMAN OTC DRUG Burkhart Stannous Fluoride GEL DENTAL 20130105 OTC MONOGRAPH FINAL part355 Burkhart Dental Supply Inc STANNOUS FLUORIDE .116 g/120g 43498-251_83462836-2e77-4ffd-88af-d46656c2ce61 43498-251 HUMAN OTC DRUG Burkhart Stannous Fluoride GEL DENTAL 20130105 OTC MONOGRAPH FINAL part355 Burkhart Dental Supply Inc STANNOUS FLUORIDE .116 g/120g 43498-300_485c8709-8293-4d29-8f8c-ae8deb218e5e 43498-300 HUMAN PRESCRIPTION DRUG Burkhart Neutral Sodium Fluoride GEL DENTAL 20130315 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE .597 g/120g 43498-301_d6dc0251-95ba-4303-b30b-211a222049de 43498-301 HUMAN PRESCRIPTION DRUG Burkhart Neutral Sodium Fluoride GEL DENTAL 20130315 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE .597 g/120g 43526-001_7f72750f-7218-4b98-954f-ae3b2b8d9012 43526-001 HUMAN OTC DRUG IPKN ARTISTS TOUCH BB 01 LIGHT TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .42; 1.108; .268 mL/14mL; mL/14mL; mL/14mL 43526-002_58a190b5-6bda-4bd1-a0a0-a85f2af3a65d 43526-002 HUMAN OTC DRUG IPKN ARTISTS TOUCH BB 02 MEDIUM TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .42; 1.108; .268 mL/14mL; mL/14mL; mL/14mL 43526-003_98f56cb1-4c6c-4bb1-a398-2a180e74ccdd 43526-003 HUMAN OTC DRUG IPKN Moist and Firm BB 01 Light TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; 3.308; .768 mL/40mL; mL/40mL; mL/40mL 43526-004_a3462cfe-78a2-4de7-a2b1-fd533db76a16 43526-004 HUMAN OTC DRUG IPKN Moist and Firm BB 02 MEDIUM TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; 3.308; .768 mL/40mL; mL/40mL; mL/40mL 43526-005_e8061fe7-d1a1-4656-809d-d661892093c7 43526-005 HUMAN OTC DRUG IPKN HYDRO AND PORE BB 01 LIGHT itanium dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 2; 4.024; 1.392 mL/40mL; mL/40mL; mL/40mL; mL/40mL 43526-006_7992879d-4cb5-4675-96f5-ea5193eafe44 43526-006 HUMAN OTC DRUG IPKN HYDRO AND PORE BB 02 MEDIUM itanium dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 2; 4.024; 1.392 mL/40mL; mL/40mL; mL/40mL; mL/40mL 43526-100_be10657e-5388-46a6-83f0-55fd5527c8d3 43526-100 HUMAN OTC DRUG IPKN ARTISTS TOUCH BB 01 LIGHT TITANIUM DIOXIDE CREAM TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .42; 1.1088; .2688 mL/14mL; mL/14mL; mL/14mL 43526-101_4f715d08-4cdd-4210-a2c4-3be4bf2991b0 43526-101 HUMAN OTC DRUG IPKN ARTISTS TOUCH BB 02 Medium TITANIUM DIOXIDE CREAM TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .42; 1.1088; .2688 mL/14mL; mL/14mL; mL/14mL 43526-102_814ff1cd-5997-4173-acef-cd09db548790 43526-102 HUMAN OTC DRUG IPKN Moist and Firm BB 01 Light TITANIUM DIOXIDE CREAM TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; 3.308; .768 mL/40mL; mL/40mL; mL/40mL 43526-103_79203944-463e-4054-a6b1-dd29919724fa 43526-103 HUMAN OTC DRUG IPKN Moist and Firm BB 02 Medium TITANIUM DIOXIDE CREAM TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; 3.308; .768 mL/40mL; mL/40mL; mL/40mL 43526-104_9720953e-1878-4413-9903-f191ff19ec74 43526-104 HUMAN OTC DRUG IPKN HYDRO AND PORE BB 01 LIGHT Titanium dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 2; 4.0248; 1.392 mL/40mL; mL/40mL; mL/40mL; mL/40mL 43526-105_4e65280b-dd17-49c2-b84e-69ab72015b3c 43526-105 HUMAN OTC DRUG IPKN HYDRO AND PORE BB 02 MEDIUM Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 2; 4.0248; 1.392 mL/40mL; mL/40mL; mL/40mL; mL/40mL 43526-106_5cc82675-9285-45f1-b3c7-75397a9e6d99 43526-106 HUMAN OTC DRUG Artists Touch BB 01 Light Titanium Dioxide, Zinc Oxide, Octinoxate, Octisalate CREAM TOPICAL 20130125 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE .49; .315; 1.2355; .672 g/7g; g/7g; g/7g; g/7g 43526-107_824b5aba-191b-49c2-af2d-5fa700596a1f 43526-107 HUMAN OTC DRUG Hydro and Pore BB TITANIUM DIOXIDE, Octinoxate, Zinc Oxide CREAM TOPICAL 20130125 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 2.876; .396 mg/40mL; mg/40mL; mg/40mL 43526-108_1f712efa-164a-4681-9d0a-a1aaeb1d19af 43526-108 HUMAN OTC DRUG IPKN Moist and Firm BB 03 Light Medium Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20130125 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 2; 4.02; 1.392 mg/40mL; mg/40mL; mg/40mL; mg/40mL 43526-109_961b3cb8-a934-4902-9ee3-74805fb75449 43526-109 HUMAN OTC DRUG IPKN Moist and Firm BB 04 Medium Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20130125 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 2; 4.02; 1.392 mg/40mL; mg/40mL; mg/40mL; mg/40mL 43526-110_c0635484-cebd-4169-b166-c99fdc89fc48 43526-110 HUMAN OTC DRUG Artists Touch BB 02 Medium Titanium Dioxide, Zinc Oxide, Octinoxate, Octisalate CREAM TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE .49; .315; 1.2355; .672 g/7g; g/7g; g/7g; 1/7g 43526-111_734e2d3f-3500-4d54-b03c-b4a46f5a118a 43526-111 HUMAN OTC DRUG IPKN MOIST AND FIRM BB 01 FAIR Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 1.88; 4.02; 1.392 mg/40mL; mg/40mL; mg/40mL; mg/40mL 43526-112_50a45e1a-ffbd-4bd6-b31d-ac2e1655a99a 43526-112 HUMAN OTC DRUG IPKN MOIST AND FIRM BB 02 Light Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 1.88; 4.02; 1.392 mg/40mL; mg/40mL; mg/40mL; mg/40mL 43526-113_de8c5b26-589c-47df-81bd-6da356f1f805 43526-113 HUMAN OTC DRUG Magis Lene Collagen Choc Extra Gold BB Cream Ethylhexyl Methoxycinnamate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140520 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 4.305; .96 g/50g; g/50g; g/50g 43526-114_57d7f88d-0404-4f23-bc03-7abed39ab315 43526-114 HUMAN OTC DRUG Magis Lene Brilliant Gold CC Cream XQ Ethylhexyl methoxycinnamate, titanium dioxide, zinc oxide CREAM TOPICAL 20140520 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.75; 3.025; 2.695 g/55g; g/55g; g/55g 43526-115_02af27cb-38f2-444b-a587-aea351a76097 43526-115 HUMAN OTC DRUG Clamue Healthy Fresh BB Cream Light Titanium Dioxide, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Zinc Oxide CREAM TOPICAL 20140606 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 1.88; 4.02; 1.392 mg/40mL; mg/40mL; mg/40mL; mg/40mL 43526-116_ac427951-3ee0-4589-a6f6-0641a6d50560 43526-116 HUMAN OTC DRUG Clamue Healthy Fresh BB Cream Light Medium Titanium Dioxide, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Zinc Oxide CREAM TOPICAL 20140606 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 1.88; 4.02; 1.392 mg/40mL; mg/40mL; mg/40mL; mg/40mL 43526-117_a3cc95ae-d1ff-45aa-8f5f-c1ccdf08b1a4 43526-117 HUMAN OTC DRUG Clamue Healthy Fresh BB Cream Medium Titanium Dioxide, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Zinc Oxide CREAM TOPICAL 20140729 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 2; 4.02; 1.392 mg/40mL; mg/40mL; mg/40mL; mg/40mL 43526-118_0ec9f5f8-dd02-4886-a29a-1ceabb81784f 43526-118 HUMAN OTC DRUG Clamue Healthy Fresh BB Cream Medium Deep Titanium Dioxide, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Zinc Oxide CREAM TOPICAL 20140729 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 2; 4.02; 1.392 mg/40mL; mg/40mL; mg/40mL; mg/40mL 43526-119_81b88e4e-dfe3-4e09-8d82-a1ecdf006f61 43526-119 HUMAN OTC DRUG Flash Radiant Primer Titanium Dioxide, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate CREAM TOPICAL 20141029 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 2; 1.2; 1.136 mg/40mL; mg/40mL; mg/40mL 43538-100_09483eb5-c6dc-486b-9311-a44bf084d489 43538-100 HUMAN PRESCRIPTION DRUG Sumaxin Cleansing Pads sulfacetamide sodium and Sulfur CLOTH TOPICAL 20090101 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 40 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 43538-101_09483eb5-c6dc-486b-9311-a44bf084d489 43538-101 HUMAN PRESCRIPTION DRUG Sumaxin CP sulfacetamide sodium and sulfur KIT 20110801 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals, Inc. 43538-120_f50924d4-e8a9-4e2a-8275-ff9539da3a62 43538-120 HUMAN PRESCRIPTION DRUG Pacnex MX Benzoyl Peroxide SOLUTION TOPICAL 20091119 UNAPPROVED OTHER Medimetriks Pharmaceuticals inc. BENZOYL PEROXIDE 42.5 mg/g 43538-130_22cd5b57-d1a0-450e-91a2-c8deb9e7742a 43538-130 HUMAN PRESCRIPTION DRUG Sumaxin Wash sodium sulfacetamide 9%-sulfur 4% SOLUTION TOPICAL 20091030 UNAPPROVED OTHER Medimetriks Pharmaceutical inc SULFACETAMIDE SODIUM; SULFUR 90; 40 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 43538-140_bc3c615e-9188-4b4d-99cb-cf877d23170e 43538-140 HUMAN PRESCRIPTION DRUG Pacnex HP Benzoyl Peroxide CLOTH TOPICAL 20100709 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals, Inc. BENZOYL PEROXIDE 70 mg/g 43538-150_45b8af89-db2d-4b15-a1ee-74290489cc50 43538-150 HUMAN PRESCRIPTION DRUG Pacnex LP Benzoyl Peroxide CLOTH TOPICAL 20100709 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals, Inc. BENZOYL PEROXIDE 42.5 mg/g 43538-160_9d10a158-2a1f-4a26-b0c9-f6964eef0e58 43538-160 HUMAN PRESCRIPTION DRUG Sumaxin TS Sodium Sulfacetamide and Sulfur LOTION TOPICAL 20100902 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals, Inc. SULFACETAMIDE SODIUM; SULFUR 80; 40 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 43538-170_14589970-0f9f-46c6-8c65-a64041b80e7c 43538-170 HUMAN PRESCRIPTION DRUG Clindacin P clindamycin phosphate SWAB TOPICAL 20110220 ANDA ANDA065049 Medimetriks Pharmaceuticals, Inc. CLINDAMYCIN PHOSPHATE 10 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 43538-171_14589970-0f9f-46c6-8c65-a64041b80e7c 43538-171 HUMAN PRESCRIPTION DRUG Clindacin PAC clindamycin phosphate SWAB TOPICAL 20110220 ANDA ANDA065049 Medimetriks Pharmaceuticals, Inc. CLINDAMYCIN PHOSPHATE 10 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 43538-172_1e113843-f54b-4371-b4a6-6043f2b0a169 43538-172 HUMAN PRESCRIPTION DRUG Clindacin ETZ clindamycin phosphate SWAB TOPICAL 20130615 ANDA ANDA065049 Medimetriks Pharmaceuticals, Inc. CLINDAMYCIN PHOSPHATE 10 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 43538-173_1e113843-f54b-4371-b4a6-6043f2b0a169 43538-173 HUMAN PRESCRIPTION DRUG Clindacin ETZ clindamycin phosphate KIT 20130615 ANDA ANDA065049 Medimetriks Pharmaceuticals, Inc. 43538-176_634dc4b0-ff38-426d-80c6-f8e8177ad6b4 43538-176 HUMAN PRESCRIPTION DRUG Neuac clindamycin phosphate and benzoyl peroxide GEL TOPICAL 20140615 ANDA ANDA090979 Medimetriks Pharmaceuticals BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 50; 10 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 43538-177_e0d19f96-36c3-4032-b9b6-24b74f186771 43538-177 HUMAN PRESCRIPTION DRUG Neuac Kit clindamycin phosphate and benzoyl peroxide KIT TOPICAL 20140615 ANDA ANDA090979 Medimetriks Pharmaceuticals 43538-180_89a3ae32-b989-4011-af8e-8e021fbcecff 43538-180 HUMAN PRESCRIPTION DRUG Rosadan metronidazole CREAM TOPICAL 20110830 ANDA ANDA077549 Medimetriks Pharmaceuticals, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 43538-181_89a3ae32-b989-4011-af8e-8e021fbcecff 43538-181 HUMAN PRESCRIPTION DRUG Rosadan metronidazole CREAM TOPICAL 20110830 ANDA ANDA077549 Medimetriks Pharmaceuticals, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 43538-182_1492cc61-6364-4278-9d32-a1e921dd9224 43538-182 HUMAN PRESCRIPTION DRUG Rosadan metronidazole GEL TOPICAL 20120415 ANDA ANDA078178 Medimetriks Pharmaceuticals, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 43538-183_1492cc61-6364-4278-9d32-a1e921dd9224 43538-183 HUMAN PRESCRIPTION DRUG Rosadan metronidazole KIT 20110801 ANDA ANDA078178 Medimetriks Pharmaceuticals, Inc. 43538-190_9660775d-0c21-4225-a11f-f52805af03c8 43538-190 HUMAN PRESCRIPTION DRUG Sumadan Wash sulfacetamide sodium and sulfur CREAM TOPICAL 20110710 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals Inc. SULFACETAMIDE SODIUM; SULFUR 90; 45 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 43538-191_9660775d-0c21-4225-a11f-f52805af03c8 43538-191 HUMAN PRESCRIPTION DRUG Sumadan sulfacetamide sodium and sulfur KIT 20110801 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals Inc. 43538-192_fcb32e4a-1128-4e6d-b1b7-8e43f60713d1 43538-192 HUMAN PRESCRIPTION DRUG SUMADAN XLT sulfacetamide sodium, sulfur, avobenzone, octinoxate, and octisalate KIT 20131201 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals Inc. 43538-210_3b8cd06b-4f93-4200-ace7-423e838a928e 43538-210 HUMAN PRESCRIPTION DRUG Uramaxin urea CREAM TOPICAL 20090101 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals, Inc. UREA 450 mg/g 43538-220_cb0bd98a-eb71-4b79-928a-471c61d3c739 43538-220 HUMAN PRESCRIPTION DRUG uramaxin urea AEROSOL, FOAM TOPICAL 20090313 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals Inc UREA 20 g/100g 43538-230_a62b506f-03ec-4227-90d9-6bdb6f6f21dd 43538-230 HUMAN PRESCRIPTION DRUG Uramaxin Urea LOTION TOPICAL 20090602 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals, Inc. UREA 450 mg/g 43538-240_c3444c4d-b690-4c48-bb5b-35994562ffb6 43538-240 HUMAN PRESCRIPTION DRUG Uramaxin TS urea CREAM TOPICAL 20100420 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals, inc. UREA 450 mg/g 43538-250_14da267a-a120-4470-97a6-fde60b1e2200 43538-250 HUMAN PRESCRIPTION DRUG Uramaxin GT UREA GEL TOPICAL 20100708 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals, Inc. UREA .45 mL/mL 43538-251_14da267a-a120-4470-97a6-fde60b1e2200 43538-251 HUMAN PRESCRIPTION DRUG Uramaxin GT Uramaxin GT and Keradan KIT 20120415 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals, Inc. 43538-260_550c578e-3372-4c63-8049-39547274f78a 43538-260 HUMAN PRESCRIPTION DRUG Uramaxin Pads Urea CLOTH TOPICAL 20101007 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals, Inc. UREA 450 mg/g 43538-290_c31434b6-b573-49a8-85bd-9f378436432b 43538-290 HUMAN OTC DRUG Niseko Sunscreen SPF 25 Avobenzone, Octinoxate, and Octisalate CREAM TOPICAL 20131115 OTC MONOGRAPH FINAL part352 Medimetriks Pharmaceuticals, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/g; mg/g; mg/g 43538-300_f2093bdd-d9dc-4199-9c20-37b4a4c15498 43538-300 HUMAN PRESCRIPTION DRUG CENTANY mupirocin OINTMENT TOPICAL 20090226 NDA NDA050788 Medimetriks Pharmaceuticals Inc MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 43538-310_aa61d796-5fc2-4349-8599-7ee5efa4f73e 43538-310 HUMAN PRESCRIPTION DRUG Centany AT Mupirocin OINTMENT TOPICAL 20101115 NDA NDA050788 Medimetriks Pharmaceuticals, Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 43538-500_24aca7fc-70b5-4ce5-a467-864007320a99 43538-500 HUMAN PRESCRIPTION DRUG Ciclodan ciclopirox SOLUTION TOPICAL 20110410 ANDA ANDA078233 Medimetriks Pharmaceuticals, Inc. CICLOPIROX 2.28 g/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 43538-501_24aca7fc-70b5-4ce5-a467-864007320a99 43538-501 HUMAN PRESCRIPTION DRUG Ciclodan ciclopirox SOLUTION TOPICAL 20110410 ANDA ANDA078233 Medimetriks Pharmaceuticals, Inc. CICLOPIROX 2.28 g/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 43538-520_c6009de8-bef7-4074-abb0-5bb8a3bcaf70 43538-520 HUMAN PRESCRIPTION DRUG ciclodan ciclopirox olamine CREAM TOPICAL 20120615 ANDA ANDA077364 Medimetriks Pharmaceuticals, Inc. CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 43538-521_c6009de8-bef7-4074-abb0-5bb8a3bcaf70 43538-521 HUMAN PRESCRIPTION DRUG Ciclodan ciclopirox olamine KIT 20120615 ANDA ANDA077364 Medimetriks Pharmaceuticals, Inc. 43538-530_1eeef376-f084-427e-8b13-98122db42c02 43538-530 HUMAN PRESCRIPTION DRUG Ketodan ketoconazole AEROSOL, FOAM TOPICAL 20120615 ANDA ANDA091550 Medimetriks Pharmaceuticals, Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 43538-531_1eeef376-f084-427e-8b13-98122db42c02 43538-531 HUMAN PRESCRIPTION DRUG Ketodan ketoconazole KIT 20120615 ANDA ANDA091550 Medimetriks Pharmaceuticals, Inc. 43538-600_73c307ad-7f7e-4d70-9013-9594782562c3 43538-600 HUMAN PRESCRIPTION DRUG Morgidox doxycycline hyclate CAPSULE ORAL 20110315 ANDA ANDA062396 Medimetriks Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 43538-601_73c307ad-7f7e-4d70-9013-9594782562c3 43538-601 HUMAN PRESCRIPTION DRUG Morgidox doxycycline hyclate CAPSULE ORAL 20110315 ANDA ANDA062396 Medimetriks Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 43538-610_73c307ad-7f7e-4d70-9013-9594782562c3 43538-610 HUMAN PRESCRIPTION DRUG Morgidox doxycycline hyclate CAPSULE ORAL 20110315 ANDA ANDA062396 Medimetriks Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 43538-611_73c307ad-7f7e-4d70-9013-9594782562c3 43538-611 HUMAN PRESCRIPTION DRUG Morgidox doxycycline hyclate CAPSULE ORAL 20110315 ANDA ANDA062396 Medimetriks Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 43538-900_843016bc-ffdd-4955-820b-9d39ccd6821f 43538-900 HUMAN PRESCRIPTION DRUG Synalar fluocinolone acetonide CREAM TOPICAL 20120927 NDA NDA012787 Medimetriks Pharmaceuticals, Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43538-901_843016bc-ffdd-4955-820b-9d39ccd6821f 43538-901 HUMAN PRESCRIPTION DRUG Synalar Fluocinolone acetonide KIT TOPICAL 20121215 NDA NDA012787 Medimetriks Pharmaceuticals, Inc. 43538-910_53f4c135-dc61-456d-9277-eff8d354f4be 43538-910 HUMAN PRESCRIPTION DRUG Synalar fluocinolone acetonide OINTMENT TOPICAL 20120927 NDA NDA013960 Medimetriks Pharmaceuticals, Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43538-911_53f4c135-dc61-456d-9277-eff8d354f4be 43538-911 HUMAN PRESCRIPTION DRUG Synalar Fluocinolone acetonide KIT TOPICAL 20121215 NDA NDA013960 Medimetriks Pharmaceuticals, Inc. 43538-920_aca116c9-db50-47e8-b456-11febdadeadf 43538-920 HUMAN PRESCRIPTION DRUG Synalar fluocinolone acetonide SOLUTION TOPICAL 20120815 NDA NDA015296 Medimetriks Pharmaceuticals, Inc. FLUOCINOLONE ACETONIDE .1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43538-920_dbe8ea0c-5ab5-4ea3-91dc-8528aa738306 43538-920 HUMAN PRESCRIPTION DRUG Synalar fluocinolone acetonide SOLUTION TOPICAL 20120531 NDA NDA015296 Medimetriks Pharmaceuticals, Inc. FLUOCINOLONE ACETONIDE .1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43538-921_aca116c9-db50-47e8-b456-11febdadeadf 43538-921 HUMAN PRESCRIPTION DRUG Synalar TS fluocinolone acetonide KIT 20120815 NDA NDA015296 Medimetriks Pharmaceuticals, Inc. 43538-921_dbe8ea0c-5ab5-4ea3-91dc-8528aa738306 43538-921 HUMAN PRESCRIPTION DRUG Synalar TS fluocinolone acetonide KIT 20120815 NDA NDA015296 Medimetriks Pharmaceuticals, Inc. 43538-940_0a6f9938-b6e6-4d4e-a461-f692a78daabe 43538-940 HUMAN PRESCRIPTION DRUG Neo-Synalar neomycin sulfate and fluocinolone acetonide CREAM TOPICAL 19630611 ANDA ANDA060700 Medimetriks Pharmaceuticals FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE .25; 3.5 mg/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43538-941_5b6a9236-9ee8-4558-919c-427e66d33131 43538-941 HUMAN PRESCRIPTION DRUG Neo-Synalar neomycin sulfate and fluocinolone acetonide KIT 20140715 ANDA ANDA060700 Medimetriks Pharmaceuticals 43538-950_07a32420-c209-43be-a7f5-753f5ab44ce4 43538-950 HUMAN PRESCRIPTION DRUG Clodan clobetasol propionate SHAMPOO TOPICAL 20140622 ANDA ANDA090974 Medimetriks Pharmaceuticals CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43538-951_e774136d-ca49-4514-a3a1-fd1635c40629 43538-951 HUMAN PRESCRIPTION DRUG Clodan Kit clobetasol propionate KIT 20140615 ANDA ANDA090974 Medimetriks Pharmaceuticals 43547-221_31c3df63-8f1d-4d10-8534-42d5a7929dd7 43547-221 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120911 ANDA ANDA078106 Solco Healthcare US LLC LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43547-222_31c3df63-8f1d-4d10-8534-42d5a7929dd7 43547-222 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120911 ANDA ANDA078106 Solco Healthcare US LLC LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43547-223_31c3df63-8f1d-4d10-8534-42d5a7929dd7 43547-223 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120911 ANDA ANDA078106 Solco Healthcare US LLC LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43547-224_31c3df63-8f1d-4d10-8534-42d5a7929dd7 43547-224 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120911 ANDA ANDA078106 Solco Healthcare US LLC LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43547-225_8abf52d1-f208-4ba0-821c-8417308a985a 43547-225 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130115 ANDA ANDA086989 Solco Healthcare US LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 43547-226_8abf52d1-f208-4ba0-821c-8417308a985a 43547-226 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130115 ANDA ANDA086988 Solco Healthcare US LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 43547-248_d1b2cf70-0b4c-4ed2-9064-5687c88d146f 43547-248 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43547-249_d1b2cf70-0b4c-4ed2-9064-5687c88d146f 43547-249 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43547-250_d1b2cf70-0b4c-4ed2-9064-5687c88d146f 43547-250 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43547-251_4146b956-96be-4115-b511-3d4cbc484ad5 43547-251 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20100515 ANDA ANDA085461 Solco Healthcare US LLC CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43547-252_4146b956-96be-4115-b511-3d4cbc484ad5 43547-252 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20100515 ANDA ANDA085472 Solco Healthcare US LLC CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43547-253_4146b956-96be-4115-b511-3d4cbc484ad5 43547-253 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20100515 ANDA ANDA085475 Solco Healthcare US LLC CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 43547-254_b6e3821c-bea7-47fd-a9f4-6769ed16f46d 43547-254 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 ANDA ANDA078384 Solco Healthcare US LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 43547-255_b6e3821c-bea7-47fd-a9f4-6769ed16f46d 43547-255 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 ANDA ANDA078384 Solco Healthcare US LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 43547-256_b6e3821c-bea7-47fd-a9f4-6769ed16f46d 43547-256 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 ANDA ANDA078384 Solco Healthcare US LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 43547-257_b6e3821c-bea7-47fd-a9f4-6769ed16f46d 43547-257 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 ANDA ANDA078384 Solco Healthcare US LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 43547-258_f11232f0-6ba0-4719-94cd-6f04562f2542 43547-258 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil SOLUTION TOPICAL 20100601 NDA NDA016831 Solco Healthcare US LLC FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 43547-259_f11232f0-6ba0-4719-94cd-6f04562f2542 43547-259 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil SOLUTION TOPICAL 20100601 NDA NDA016831 Solco Healthcare US LLC FLUOROURACIL 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 43547-263_48be1cda-69dc-46d9-a2c4-55d4a5ef04fa 43547-263 HUMAN PRESCRIPTION DRUG benzphetamine hydrochloride benzphetamine hydrochloride TABLET ORAL 20110801 ANDA ANDA090473 Solco Healthcare US LLC BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 43547-264_7fbc0874-0178-46d6-a880-cdb3854c4a93 43547-264 HUMAN PRESCRIPTION DRUG phendimetrazine tartrate phendimetrazine tartrate TABLET ORAL 20110801 ANDA ANDA089452 Solco Healthcare US LLC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 43547-265_9e722109-1eef-40c2-8e93-46ef9fb42029 43547-265 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20121015 ANDA ANDA090007 Solco healthcare U.S., LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43547-266_9e722109-1eef-40c2-8e93-46ef9fb42029 43547-266 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20121015 ANDA ANDA090007 Solco healthcare U.S., LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43547-267_9e722109-1eef-40c2-8e93-46ef9fb42029 43547-267 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20121015 ANDA ANDA090007 Solco healthcare U.S., LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43547-268_25d02934-6d2a-4b7a-b802-0f497b251da4 43547-268 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Solco healthcare U.S., LLC ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 43547-269_25d02934-6d2a-4b7a-b802-0f497b251da4 43547-269 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Solco healthcare U.S., LLC ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 43547-270_25d02934-6d2a-4b7a-b802-0f497b251da4 43547-270 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Solco healthcare U.S., LLC ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 43547-271_25d02934-6d2a-4b7a-b802-0f497b251da4 43547-271 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Solco healthcare U.S., LLC ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 43547-272_25d02934-6d2a-4b7a-b802-0f497b251da4 43547-272 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Solco healthcare U.S., LLC ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 43547-273_25d02934-6d2a-4b7a-b802-0f497b251da4 43547-273 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Solco healthcare U.S., LLC ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 43547-274_25d02934-6d2a-4b7a-b802-0f497b251da4 43547-274 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Solco healthcare U.S., LLC ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 43547-275_d30c6e37-1d2d-4d4b-b67e-622ebd1d344a 43547-275 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20111101 ANDA ANDA200292 Solco Healthcare US, LLC DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 43547-276_d30c6e37-1d2d-4d4b-b67e-622ebd1d344a 43547-276 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20111101 ANDA ANDA200292 Solco Healthcare US, LLC DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 43547-277_eff37327-ff5c-4b80-9ffe-3ab00635bd3f 43547-277 HUMAN PRESCRIPTION DRUG Irbesartan IRBESARTAN TABLET ORAL 20120927 ANDA ANDA203071 Solco healthcare U.S., LLC IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 43547-278_eff37327-ff5c-4b80-9ffe-3ab00635bd3f 43547-278 HUMAN PRESCRIPTION DRUG Irbesartan IRBESARTAN TABLET ORAL 20120927 ANDA ANDA203071 Solco healthcare U.S., LLC IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 43547-279_eff37327-ff5c-4b80-9ffe-3ab00635bd3f 43547-279 HUMAN PRESCRIPTION DRUG Irbesartan IRBESARTAN TABLET ORAL 20120927 ANDA ANDA203071 Solco healthcare U.S., LLC IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 43547-320_08297a45-dcc8-469a-9276-4490f078d303 43547-320 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20130415 ANDA ANDA090888 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43547-321_08297a45-dcc8-469a-9276-4490f078d303 43547-321 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20130415 ANDA ANDA090888 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43547-322_08297a45-dcc8-469a-9276-4490f078d303 43547-322 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20130415 ANDA ANDA090888 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43547-330_72fa8cd4-bc2a-4a7d-8feb-2d60e077d801 43547-330 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20140301 ANDA ANDA203072 Solco Healthcare US, LLC HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43547-331_72fa8cd4-bc2a-4a7d-8feb-2d60e077d801 43547-331 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20140301 ANDA ANDA203072 Solco Healthcare US, LLC HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 43547-332_97bb6fc3-874b-47eb-95d3-203dd5434b66 43547-332 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN TABLET, FILM COATED ORAL 20141101 ANDA ANDA203244 Solco healthcare U.S., LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43547-333_97bb6fc3-874b-47eb-95d3-203dd5434b66 43547-333 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN TABLET, FILM COATED ORAL 20141101 ANDA ANDA203244 Solco healthcare U.S., LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 43547-335_bb91223e-ffa5-4a3a-b191-fe121250c20c 43547-335 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Solco healthcare U.S., LLC BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 43547-336_bb91223e-ffa5-4a3a-b191-fe121250c20c 43547-336 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Solco healthcare U.S., LLC BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 43547-337_bb91223e-ffa5-4a3a-b191-fe121250c20c 43547-337 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Solco healthcare U.S., LLC BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 43547-338_bb91223e-ffa5-4a3a-b191-fe121250c20c 43547-338 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Solco healthcare U.S., LLC BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 43547-347_6cfde064-ddcb-49df-a53c-953c40eb1470 43547-347 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20141101 ANDA ANDA203854 Solco Healthcare US, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43547-348_6cfde064-ddcb-49df-a53c-953c40eb1470 43547-348 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20141101 ANDA ANDA203854 Solco Healthcare US, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43547-349_6cfde064-ddcb-49df-a53c-953c40eb1470 43547-349 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20141101 ANDA ANDA203854 Solco Healthcare US, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43547-350_6cfde064-ddcb-49df-a53c-953c40eb1470 43547-350 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20141101 ANDA ANDA203854 Solco Healthcare US, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 43547-357_b741ccd1-dfc1-42ad-9bf8-3f98ffd3055b 43547-357 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20141015 ANDA ANDA203769 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43547-358_b741ccd1-dfc1-42ad-9bf8-3f98ffd3055b 43547-358 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20141015 ANDA ANDA203769 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43547-359_b741ccd1-dfc1-42ad-9bf8-3f98ffd3055b 43547-359 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20141015 ANDA ANDA203769 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 43553-0001_3eb23540-9faa-4f90-b115-809674c2fb01 43553-0001 HUMAN OTC DRUG ALOE VESTA DAILY MOISTURIZER DIMETHICONE LOTION TOPICAL 20131220 OTC MONOGRAPH FINAL part347 ConvaTec, Inc. DIMETHICONE 30 mg/mL 43553-0002_c8b10a56-c62e-4845-968f-50bdd3465956 43553-0002 HUMAN OTC DRUG SENSI-CARE BODY PETROLATUM, DIMETHICONE CREAM TOPICAL 20131220 OTC MONOGRAPH FINAL part347 ConvaTec Inc. DIMETHICONE; PETROLATUM 1; 30 g/100g; g/100g 43553-0003_aab159c8-60ba-4979-b360-68126b36eb93 43553-0003 HUMAN OTC DRUG Aloe Vesta Clear Antifungal MICONAZOLE NITRATE OINTMENT TOPICAL 20131220 OTC MONOGRAPH FINAL part333C Convatec Inc. MICONAZOLE NITRATE 2 g/100g 43553-0004_4ee20b11-d397-4cd1-b162-167b90d8699d 43553-0004 HUMAN OTC DRUG ALOE VESTA CLEAR BARRIER PETROLATUM SPRAY TOPICAL 20131220 OTC MONOGRAPH FINAL part347 ConvaTec Inc. PETROLATUM 36 g/100g 43553-0007_d73eaba1-ec5d-4434-bf38-6d45e133f913 43553-0007 HUMAN OTC DRUG SENSI CARE CLEAR ZINC DIMETHICONE, ZINC OXIDE CREAM TOPICAL 20140612 OTC MONOGRAPH FINAL part347 ConvaTec Inc DIMETHICONE; ZINC OXIDE 5; 5 g/100g; g/100g 43553-3244_5f94fd2e-b803-4b42-885d-f25cb63297db 43553-3244 HUMAN OTC DRUG SENSI CARE MOISTURIZING BODY PETROLATUM CREAM TOPICAL 19980415 OTC MONOGRAPH FINAL part347 ConvaTec, Inc. DIMETHICONE; PETROLATUM 10; 300 mg/g; mg/g 43553-3248_9318e568-74d8-4589-84da-f76131ecbf2c 43553-3248 HUMAN OTC DRUG ALOE VESTA SKIN CONDITIONER SKIN CONDITIONER LOTION TOPICAL 19980415 OTC MONOGRAPH FINAL part347 ConvaTec, Inc. DIMETHICONE .03 mg/mL 43553-3249_b33d6cd8-dc31-4721-b7b4-cc4c3aba85e6 43553-3249 HUMAN OTC DRUG ALOE VESTA PROTECTIVE PETROLATUM OINTMENT TOPICAL 20010223 OTC MONOGRAPH FINAL part347 ConvaTec, Inc. PETROLATUM 430 mg/g 43553-3251_3cc7fd25-d33f-41ea-8f0c-49402a01e386 43553-3251 HUMAN OTC DRUG ALOE VESTA ANTIFUNGAL MICONAZOLE NITRATE OINTMENT TOPICAL 19971003 OTC MONOGRAPH FINAL part333C ConvaTec, Inc. MICONAZOLE NITRATE 20 mg/g 43553-3256_3ce83c76-38ac-45f8-a905-4c76fb573daf 43553-3256 HUMAN OTC DRUG SENSI CARE PROTECTIVE BARRIER PETROLATUM, ZINC OXIDE CREAM TOPICAL 20000105 OTC MONOGRAPH FINAL part347 ConvaTec Inc. PETROLATUM; ZINC OXIDE 490; 150 mg/g; mg/g 43553-4134_c83c8a0d-a979-4024-9f02-01392449ecbc 43553-4134 HUMAN OTC DRUG ALOE VESTA PROTECTIVE BARRIER PETROLATUM SPRAY TOPICAL 20050113 OTC MONOGRAPH FINAL part347 ConvaTec, Inc. PETROLATUM 360 mg/g 43555-020_868bf139-2f4c-478c-84ee-d8d3546eaa5b 43555-020 HUMAN PRESCRIPTION DRUG OXYGEN, COMPRESSED OXYGEN, COMPRESSED GAS RESPIRATORY (INHALATION) 20100802 UNAPPROVED MEDICAL GAS CLEAN-OX, INC OXYGEN 1 L/L 43595-080_561c24c0-416a-4e45-abea-3e184a44e3b0 43595-080 HUMAN PRESCRIPTION DRUG Oleptro Trazodone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100202 NDA NDA022411 Angelini Pharma Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 43595-081_561c24c0-416a-4e45-abea-3e184a44e3b0 43595-081 HUMAN PRESCRIPTION DRUG Oleptro Trazodone hydrochloride TABLET, EXTENDED RELEASE ORAL 20100202 NDA NDA022411 Angelini Pharma Inc. TRAZODONE HYDROCHLORIDE 300 mg/1 Serotonin Reuptake Inhibitor [EPC] 43596-0001_fb098a50-da0c-4609-9983-577a69896601 43596-0001 HUMAN OTC DRUG LBEL DEFENSE 365 Daily Protective Facial SPF 50 HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20120325 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 5; 7; 5; 4; 6.24; 3.92 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 43596-0002_3728f4b5-7b55-476c-b03b-f108a69ce153 43596-0002 HUMAN OTC DRUG LBEL HYDRA CALME SPF 15 Intensive Moisturizing Facial OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20120325 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 4 mL/100mL; mL/100mL; mL/100mL 43596-0003_7def8495-7f74-4981-943c-a9f9aa0faf5e 43596-0003 HUMAN OTC DRUG LBEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Normal to Combination Skin OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20120327 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 4 mL/100mL; mL/100mL; mL/100mL 43596-0004_07071b9d-506e-4620-9cb9-04a754abd06c 43596-0004 HUMAN OTC DRUG LBEL RENOVANCE JOUR Daytime Face SPF 15 All Skin Types OCTINOXATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20120328 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 3 g/100g; g/100g; g/100g 43596-0005_28f26674-ce97-4c85-b3a0-392e79366e7f 43596-0005 HUMAN OTC DRUG LBEL SUPREMACIE NX JOUR Replenishing Treatment Daytime Face SPF 15 Normal To Dry Skin ENSULIZOLE, HOMOSALATE, OCTINOXATE, OXYBENZONE CREAM TOPICAL 20120328 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD ENSULIZOLE; HOMOSALATE; OCTINOXATE; OXYBENZONE 2; 2; 7.5; 4 g/100g; g/100g; g/100g; g/100g 43596-0006_a4002681-ce35-45e9-8d57-7e71e9b5095b 43596-0006 HUMAN OTC DRUG LBEL SUPREMACIE NX JOUR Replenishing Daytime Face SPF 15 Normal To Oily Skin ENSULIZOLE, HOMOSALATE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20120328 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD ENSULIZOLE; HOMOSALATE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 1.5; 1; 7.5; 4.5; 1.17 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 43596-0007_f3d8ea25-315a-4287-8fc0-cb2766f5eccf 43596-0007 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - CLAIRE 1 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43596-0008_c55c89f9-f25e-4962-88d0-5fc16123c9f8 43596-0008 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - CLAIRE 2 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43596-0009_78947038-1060-4ba9-8335-c477a97bfe21 43596-0009 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - CLAIRE 3 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43596-0010_15ff9a2f-54ac-4546-8ac7-735c7be2b2c1 43596-0010 HUMAN OTC DRUG LBEL EFET PARFAIT Spots Reducing Effect Foundation SPF 18 - CLAIRE 4 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43596-0011_626744ac-3145-45b3-829d-83c6fa322017 43596-0011 HUMAN OTC DRUG LBEL EFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 5 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43596-0012_b36dfc42-f5e8-4560-accc-d83f0940bac5 43596-0012 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 6 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43596-0013_25b1911b-8d5d-4266-be09-de1a8e110679 43596-0013 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 7 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43596-0014_f53f92b2-c555-47f5-99cb-3d0d5bb8465d 43596-0014 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 8 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43596-0015_3831ffdb-ece4-4c1b-a493-210b542fea50 43596-0015 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 6A OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43596-0016_1c10361b-b4d9-4936-bde7-fc16f1070d7a 43596-0016 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 6B OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43596-0017_f34a5835-5cf6-4907-92c2-cbd90691d350 43596-0017 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 8A OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43596-0018_250f5093-29c3-46ea-9d99-4c98a1671439 43596-0018 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 8B OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43596-0019_6388c4dc-6d8f-4d06-885c-84fe0c08f912 43596-0019 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 8C OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43596-0020_9674a2d4-f1a7-4161-88bc-c0533b1d7288 43596-0020 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 10 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g 43596-0021_b2719932-5125-4491-8c56-1a6dac4039ef 43596-0021 HUMAN OTC DRUG Esika Men Dandruff Maximum Strength PYRITHIONE ZINC SHAMPOO TOPICAL 20121003 OTC MONOGRAPH FINAL part358H Ventura Corporation Limited PYRITHIONE ZINC 5.28 mg/mL 43596-0022_24e804c1-1f96-4ead-a56c-7bed8e766f6c 43596-0022 HUMAN OTC DRUG Esika Passion Musk Antiperspirant Roll-On Deodorant ALUMINUM SESQUICHLOROHYDRATE CREAM TOPICAL 20120820 OTC MONOGRAPH FINAL part350 Ventura Corporation Limited ALUMINUM SESQUICHLOROHYDRATE 13.6 mg/100mL 43598-003_0756200b-9953-58d9-b495-409d3cbf8c1d 43598-003 HUMAN PRESCRIPTION DRUG AUGMENTIN ES-600 amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20121031 NDA NDA050755 Dr Reddys Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 43598-004_828964bb-7b47-8289-4927-567a9ffdc868 43598-004 HUMAN PRESCRIPTION DRUG AUGMENTIN amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050575 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 250; 62.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 43598-006_828964bb-7b47-8289-4927-567a9ffdc868 43598-006 HUMAN PRESCRIPTION DRUG AUGMENTIN amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19901022 NDA NDA050564 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; 1/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 43598-012_828964bb-7b47-8289-4927-567a9ffdc868 43598-012 HUMAN PRESCRIPTION DRUG AUGMENTIN amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050575 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 125; 31.25 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 43598-018_828964bb-7b47-8289-4927-567a9ffdc868 43598-018 HUMAN PRESCRIPTION DRUG AUGMENTIN amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19901022 NDA NDA050564 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43598-020_403f620b-fbf3-3bb3-88e7-c69ee5c9527d 43598-020 HUMAN PRESCRIPTION DRUG AUGMENTIN XR amoxicillin and clavulanate potassium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030911 NDA NDA050785 Dr Reddys Laboratories Inc AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM 562.5; 437.5; 62.5 mg/1; mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 43598-021_828964bb-7b47-8289-4927-567a9ffdc868 43598-021 HUMAN PRESCRIPTION DRUG AUGMENTIN amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19961002 NDA NDA050720 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; 1/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 43598-164_8031dcd4-af65-51f9-40dd-5bc626f666d5 43598-164 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20131210 ANDA ANDA076255 Dr.Reddy's Laboratories Inc OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 43598-165_8031dcd4-af65-51f9-40dd-5bc626f666d5 43598-165 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20131210 ANDA ANDA076255 Dr.Reddy's Laboratories Inc OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 43598-166_8031dcd4-af65-51f9-40dd-5bc626f666d5 43598-166 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20131210 ANDA ANDA076255 Dr.Reddy's Laboratories Inc OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 43598-203_15441e10-a11b-457f-bfd4-e05604691500 43598-203 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20010622 NDA NDA050755 Dr Reddys Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 43598-204_c4efe539-d8ef-dce0-59e8-fedc7fac83dd 43598-204 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050575 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 250; 62.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 43598-205_75ca51d0-343c-48c2-9873-2a3c45e8ffe8 43598-205 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin CAPSULE ORAL 19790802 ANDA ANDA062216 Dr Reddys Laboratories Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43598-206_c4efe539-d8ef-dce0-59e8-fedc7fac83dd 43598-206 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19901022 NDA NDA050564 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 43598-207_c4f92484-5755-4046-93dd-772db30acebb 43598-207 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin POWDER, FOR SUSPENSION ORAL 19990415 NDA NDA050760 Dr Reddys Laboratories Inc AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43598-208_c4efe539-d8ef-dce0-59e8-fedc7fac83dd 43598-208 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050725 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43598-209_75ca51d0-343c-48c2-9873-2a3c45e8ffe8 43598-209 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin POWDER, FOR SUSPENSION ORAL 19790919 ANDA ANDA062226 Dr Reddys Laboratories Inc AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43598-210_1b9eafb8-74a8-595a-9822-f8fed0a5c542 43598-210 HUMAN PRESCRIPTION DRUG SSD Cream Silver Sulfadiazine CREAM TOPICAL 20110504 NDA NDA018578 Dr Reddys Laboratories Inc SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 43598-213_c4efe539-d8ef-dce0-59e8-fedc7fac83dd 43598-213 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050725 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 43598-218_c4efe539-d8ef-dce0-59e8-fedc7fac83dd 43598-218 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19901022 NDA NDA050564 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 43598-219_c4f92484-5755-4046-93dd-772db30acebb 43598-219 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin TABLET, FILM COATED ORAL 19780710 NDA NDA050754 Dr Reddys Laboratories Inc AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43598-220_281d6c99-708d-bd90-e14e-dd9e6749db4b 43598-220 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Extended Release amoxicillin and clavulanate potassium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030911 NDA NDA050785 Dr. Reddy's Laboratories Inc AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM 562.5; 437.5; 62.5 mg/1; mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 43598-221_c4efe539-d8ef-dce0-59e8-fedc7fac83dd 43598-221 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19961002 NDA NDA050720 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 43598-222_75ca51d0-343c-48c2-9873-2a3c45e8ffe8 43598-222 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin POWDER, FOR SUSPENSION ORAL 19790919 ANDA ANDA062226 Dr Reddys Laboratories Inc AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43598-223_c4f92484-5755-4046-93dd-772db30acebb 43598-223 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin POWDER, FOR SUSPENSION ORAL 19990415 NDA NDA050760 Dr Reddys Laboratories Inc AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43598-224_c4f92484-5755-4046-93dd-772db30acebb 43598-224 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin TABLET, FILM COATED ORAL 19780710 NDA NDA050754 Dr Reddys Laboratories Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43598-225_75ca51d0-343c-48c2-9873-2a3c45e8ffe8 43598-225 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin CAPSULE ORAL 19790802 ANDA ANDA062216 Dr Reddys Laboratories Inc AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 43598-258_efa4eb2a-8ec3-9582-f62d-d52607e1ded5 43598-258 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION INTRAVENOUS 20141110 ANDA ANDA204193 Dr. Reddy's Laboratories Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 43598-259_efa4eb2a-8ec3-9582-f62d-d52607e1ded5 43598-259 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION INTRAVENOUS 20141110 ANDA ANDA204193 Dr. Reddy's Laboratories Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 43598-303_10d392b5-29f3-5e73-bd02-b3652d2dcfac 43598-303 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET ORAL 20121025 ANDA ANDA090061 Dr Reddys Laboratories Inc FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 43598-305_cb96bfc3-8231-461e-bad0-c7dc0c619610 43598-305 HUMAN PRESCRIPTION DRUG Azacitidine Azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20130919 ANDA ANDA201537 Dr. Reddy's Laboratories Inc. AZACITIDINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 43598-313_1ec5863b-f1a9-7dcf-419a-1b0fa854cbec 43598-313 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43598-314_1ec5863b-f1a9-7dcf-419a-1b0fa854cbec 43598-314 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43598-315_1ec5863b-f1a9-7dcf-419a-1b0fa854cbec 43598-315 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43598-316_1ec5863b-f1a9-7dcf-419a-1b0fa854cbec 43598-316 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43598-317_1ec5863b-f1a9-7dcf-419a-1b0fa854cbec 43598-317 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 2.5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43598-318_1ec5863b-f1a9-7dcf-419a-1b0fa854cbec 43598-318 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43598-319_1ec5863b-f1a9-7dcf-419a-1b0fa854cbec 43598-319 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43598-320_1ec5863b-f1a9-7dcf-419a-1b0fa854cbec 43598-320 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 2.5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43598-321_1ec5863b-f1a9-7dcf-419a-1b0fa854cbec 43598-321 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43598-322_1ec5863b-f1a9-7dcf-419a-1b0fa854cbec 43598-322 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43598-323_1ec5863b-f1a9-7dcf-419a-1b0fa854cbec 43598-323 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 43598-330_e336a15a-bd50-3dbb-a298-ede923dbdae7 43598-330 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130819 ANDA ANDA091186 Dr. Reddy's Laboratories Inc. ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 43598-331_afef3df8-7823-70c9-0b04-a3bdbf45aa42 43598-331 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION INTRAVENOUS 20130819 ANDA ANDA091363 Dr.Reddy's Laboratories Inc ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 43598-341_c98209e6-a607-a8c9-9db3-529b9a59752d 43598-341 HUMAN PRESCRIPTION DRUG clocortolone pivalate clocortolone pivalate CREAM TOPICAL 20140217 NDA AUTHORIZED GENERIC NDA017765 Dr. Reddy's Laboratories Inc CLOCORTOLONE PIVALATE .001 g/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43598-348_bf9728a8-848d-9fdc-1647-f11a11b45758 43598-348 HUMAN PRESCRIPTION DRUG Decitabine Decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130711 ANDA ANDA203131 Dr.Reddy's Laboratories Inc DECITABINE 50 mg/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 43598-390_f616d1d6-6805-10b5-599e-67a3b6bd8977 43598-390 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20140610 ANDA ANDA090060 Dr Reddys Laboratories Inc FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 43598-409_13c2f13e-32da-66f4-294e-a89c3f50a206 43598-409 HUMAN PRESCRIPTION DRUG levalbuterol inhalation levalbuterol inhalation 1.25mg/3mL SOLUTION RESPIRATORY (INHALATION) 20140916 ANDA ANDA078171 Dr. Reddy?s Laboratories, Inc. LEVALBUTEROL 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 43598-410_13c2f13e-32da-66f4-294e-a89c3f50a206 43598-410 HUMAN PRESCRIPTION DRUG levalbuterol inhalation levalbuterol inhalation 0.63mg/3mL SOLUTION RESPIRATORY (INHALATION) 20140916 ANDA ANDA078171 Dr. Reddy?s Laboratories, Inc. LEVALBUTEROL .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 43598-412_13c2f13e-32da-66f4-294e-a89c3f50a206 43598-412 HUMAN PRESCRIPTION DRUG levalbuterol inhalation levalbuterol inhalation 0.31mg/3mL SOLUTION RESPIRATORY (INHALATION) 20140916 ANDA ANDA078171 Dr. Reddy?s Laboratories, Inc. LEVALBUTEROL .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 43598-427_90feb0e8-39f8-f0ae-e93f-47bec00cf189 43598-427 HUMAN PRESCRIPTION DRUG Decitabine Decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141205 ANDA ANDA203131 Dr.Reddy's Laboratories Inc DECITABINE 50 mg/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 43599-001_9607b57d-542f-46fd-b575-01cb3be6ee01 43599-001 HUMAN OTC DRUG NAMMAN MUAY Athletes Pain Relieving MENTHOL, METHYL SALICYLATE LINIMENT TOPICAL 20110610 OTC MONOGRAPH NOT FINAL part348 Devakam Apothecary Hall, Co, Ltd. MENTHOL; METHYL SALICYLATE 12.5; 310 mg/mL; mg/mL 43611-001_0cfd1122-9991-4b4a-87f1-44c99c849b14 43611-001 HUMAN OTC DRUG Melvita PROSUN SPF 30 Sun TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110912 OTC MONOGRAPH NOT FINAL part352 Laboratoires M&L TITANIUM DIOXIDE; ZINC OXIDE 93.05; 195 mg/mL; mg/mL 43611-002_b34d0ae5-bda0-48eb-94cc-3caa57f68c2a 43611-002 HUMAN OTC DRUG Melvita PROSUN SPF 15 Sun TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110912 OTC MONOGRAPH NOT FINAL part352 Laboratoires M&L TITANIUM DIOXIDE; ZINC OXIDE 59.05; 120 mg/mL; mg/mL 43611-003_075845de-4a3e-4828-b8fe-af4947bc5e9a 43611-003 HUMAN OTC DRUG Melvita PROSUN High protection sunscreen Broad Spectrum SPF 50 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part352 Laboratoires M&L TITANIUM DIOXIDE; ZINC OXIDE 65; 250 mg/mL; mg/mL 43611-004_4866661d-070f-4f04-92b6-8017dedadf58 43611-004 HUMAN OTC DRUG Melvita PROSUN High protection sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part352 Laboratoires M&L TITANIUM DIOXIDE; ZINC OXIDE 50; 200 mg/mL; mg/mL 43611-005_dd173fca-b674-413c-ba72-b762db9bfe72 43611-005 HUMAN OTC DRUG Melvita UV shield - Sunscreen SPF 15 Broad spectrum TITANIUM DIOXIDE LOTION TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part352 Laboratoires M&L TITANIUM DIOXIDE 70 mg/mL 43611-006_7689cc8d-3478-4197-8e74-23c51e32bb21 43611-006 HUMAN OTC DRUG Melvita NECTAR DE ROSES BB Sunscreen BROAD SPECTRUM SPF 15 NUDE ROSE TITANIUM DIOXIDE CREAM TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part352 Laboratoires M&L TITANIUM DIOXIDE 80 mg/mL 43617-3415_30c41d95-0796-4904-98b2-36655e8b6fbc 43617-3415 HUMAN OTC DRUG LANOCREME HYDRATING DAY SPF15 AVOBENZONE, OXYBENZONE, OCTYL METHOXYCINNAMATE CREAM TOPICAL 20120430 OTC MONOGRAPH NOT FINAL part352 Lanocorp Pacific Ltd AVOBENZONE; OCTINOXATE; OXYBENZONE 1.5; 7.5; 1.5 g/50g; g/50g; g/50g 43617-3416_6036bdbc-2f41-4933-adfa-c821ad6f343e 43617-3416 HUMAN OTC DRUG By Nature Hydrating Day SPF 15 AVOBENZONE, OXYBENZONE, OCTYL METHOXYCINNAMATE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Lanocorp Pacific Ltd AVOBENZONE; OCTINOXATE; OXYBENZONE 1.5; 7.5; 1.5 g/50g; g/50g; g/50g 43617-3417_c3e6ebb6-8f52-410d-a0bc-582de5226e1e 43617-3417 HUMAN OTC DRUG By Nature Daily Face Sunscreen Broad Spectrum SPF 30 OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Lanocorp Pacific Ltd AVOBENZONE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 25; 75; 45; 50 g/g; g/g; g/g; g/g 43621-001_b2d9b6a1-0988-4217-b86e-21836bed7295 43621-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS DJB Gas Services, Inc OXYGEN 990 mL/L 43645-112_6c90e09c-fb30-4508-87a2-c55d3a670d1d 43645-112 HUMAN OTC DRUG Miconole Miconazole Nitrate CREAM TOPICAL 20131015 OTC MONOGRAPH FINAL part333C Option Labs MICONAZOLE NITRATE 20 mg/g 43689-0001_f9e95868-da01-483c-a753-b7f87cda8ec1 43689-0001 HUMAN OTC DRUG Urinary Incontinence Relief Causticum, Natrum muriaticum, Nus vomica, Pulsatilla, Sepia, Staphysagria, Thuja occidentalis, TABLET ORAL 20120717 UNAPPROVED HOMEOPATHIC The Magni Company CAUSTICUM; DELPHINIUM STAPHISAGRIA SEED; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12; 12; 12; 12 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 43689-0002_828d2f86-655a-44f8-b183-f46dfcdfdd29 43689-0002 HUMAN OTC DRUG Sleep Assist Chamomilla, Coffea cruda, Avena sativa, Nux Vomica, Passiflora incarnata, TABLET, ORALLY DISINTEGRATING ORAL 20120910 UNAPPROVED HOMEOPATHIC The Magni Company ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED 4; 6; 4; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 43689-0003_756826af-8731-4c1c-9a43-58c48c1c0948 43689-0003 HUMAN OTC DRUG Fibromyalgia Relief Aconitum Napellus, Arsenicum Album, Belladonna, Coniinum, Gelsemium Sempervirens, Hypericum Perforatum, Kali Bichromicum TABLET ORAL 20121011 UNAPPROVED HOMEOPATHIC The Magni Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CONIINE; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; LACTIC ACID, DL-; PHOSPHORIC ACID; POTASSIUM DICHROMATE; TOXICODENDRON PUBESCENS LEAF; URIC ACID 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_X]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg 43689-0004_8edb5216-baa8-41b0-9eda-c9008d03a444 43689-0004 HUMAN OTC DRUG Leg Cramp Relief Causticum, Colocynthis, Cuprum Metallicum, Magnesia Phosphorica, Phytolacca Decandra, Rhus Toxicodendron TABLET ORAL 20121010 UNAPPROVED HOMEOPATHIC The Magni Company CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; TIN; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 43689-0005_45431a29-5e9f-42f3-9f25-06d2d0dcefc0 43689-0005 HUMAN OTC DRUG Restless Legs Relief Aconitum Napellus, Gnaphalium Polycephalum, Ledum Palustre, Magnesia Phosphorica, Rhus Toxicodendron TABLET ORAL 20130326 UNAPPROVED HOMEOPATHIC The Magni Company ACONITUM NAPELLUS; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP 6; 6; 6; 4; 6; 4 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 43689-0007_191f3bd1-b35e-4236-8492-57228d8d579a 43689-0007 HUMAN OTC DRUG Sciatica Relief Capsicum annuum, Colocynthis, Gnaphalium polycephalum, Magnesia phosphorica, TABLET ORAL 20121011 UNAPPROVED HOMEOPATHIC Magni Company CAPSICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 43689-0009_624c1635-0cca-499a-b2d6-ef58f6bd41d0 43689-0009 HUMAN OTC DRUG Tinnitus Relief Calcarea Carbonica, Chininum Sulphuricum, Kali Carbonicum, Lycopodium Clavatum, Salicylicum Acidum TABLET ORAL 20120816 UNAPPROVED HOMEOPATHIC The Magni Company LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; QUININE SULFATE; SALICYLIC ACID 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 43689-0010_9fd17902-3146-4545-8ead-7c6374f2cc31 43689-0010 HUMAN OTC DRUG Migraine Relief not applicable TABLET, ORALLY DISINTEGRATING ORAL 20140717 UNAPPROVED HOMEOPATHIC The Magni Company ARABICA COFFEE BEAN; ATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; IRIS VERSICOLOR ROOT; MATRICARIA RECUTITA; NITROGLYCERIN; PASSIFLORA INCARNATA FLOWERING TOP; SODIUM CHLORIDE; VALERIAN 3; 6; 6; 6; 6; 3; 12; 3; 6; 3 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 43695-0001_efc656c5-7f47-43e8-abec-a919b8680ca8 43695-0001 HUMAN OTC DRUG Libido for Her Agnus castus, Berberis vulgaris, Damiana, Graphites, Ignatia amara, Lactuca virosa, Onosmodium virginianum, SPRAY ORAL 20120425 UNAPPROVED HOMEOPATHIC Pacific Naturals BERBERIS VULGARIS ROOT BARK; CHASTE TREE; GRAPHITE; LACTUCA VIROSA; ONOSMODIUM VIRGINIANUM WHOLE; STRYCHNOS IGNATII SEED; TURNERA DIFFUSA LEAFY TWIG 6; 3; 8; 3; 30; 6; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43695-0002_43423bb3-2646-4d2f-88a7-122662701e27 43695-0002 HUMAN OTC DRUG Smoke Deter ABIES NIGRA, ACONITUM NAPELLUS, ARSENICUM IODATUM, AVENA SATIVA, IGNATIA AMARA, LUNG SUIS, NUX VOMICA, SPRAY ORAL 20141218 UNAPPROVED HOMEOPATHIC Pacific Naturals ACONITUM NAPELLUS; ARSENIC TRIIODIDE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; AVENA SATIVA FLOWERING TOP; LOBARIA PULMONARIA; PICEA MARIANA RESIN; PLANTAGO MAJOR; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA LUNG; TOBACCO LEAF 200; 200; 3; 1; 200; 10; 3; 200; 10; 6; 200 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 43695-0003_f0b13d9b-53b3-45a8-a0ae-6992b8b6ec30 43695-0003 HUMAN OTC DRUG Venapro Aesculus hippocastanum, Arnica montana, Calcarea fluorica, Carduus marianus, Collinsonia canadensis, Hamamelis virginiana, Muriaticum acidum, Ratanhia, SPRAY ORAL 20140515 UNAPPROVED HOMEOPATHIC Pacific Naturals ARNICA MONTANA; CALCIUM FLUORIDE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROCHLORIC ACID; KRAMERIA LAPPACEA ROOT; MILK THISTLE 3; 10; 3; 1; 1; 6; 3; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43695-0004_731a86c4-a67b-4d5a-9b66-96a81fb683cb 43695-0004 HUMAN OTC DRUG Miracet Abies Nigra, Aconitum Napellus, Arsenicum Iodatum, Avena Sativa, Ignatia Amara, Lung Suis, Nux Vomica, Plantago Major, Quebracho LIQUID ORAL 20130801 UNAPPROVED HOMEOPATHIC Pacific Naturals ACONITUM NAPELLUS; ARSENIC TRIIODIDE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; AVENA SATIVA FLOWERING TOP; LOBARIA PULMONARIA; PICEA MARIANA RESIN; PLANTAGO MAJOR; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA LUNG; TOBACCO LEAF 200; 200; 3; 1; 200; 10; 3; 200; 10; 6; 200 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 43695-0005_4601c733-7276-46b1-894f-eb8f6062c9d5 43695-0005 HUMAN OTC DRUG Zeta Clear Antimonium Crudum, Arsenicum Album, Mancinella, Nitricum Acidum, Sulphur, Thuja Occidentalis LIQUID ORAL 20130425 UNAPPROVED HOMEOPATHIC Pacific Naturals ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; NITRIC ACID; SULFUR; THUJA OCCIDENTALIS LEAF 200; 200; 30; 30; 12; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 43695-0009_f0c7c0f2-0181-406c-a692-8a9d1c637879 43695-0009 HUMAN OTC DRUG TINNITUS CONTROL NOT APPLICABLE LIQUID ORAL 20141014 UNAPPROVED HOMEOPATHIC Pacific Naturals ALLYLTHIOUREA; ARNICA MONTANA; IRON; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; QUININE SULFATE; SILICON DIOXIDE; SODIUM SULFATE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43734-001_a98969bd-a495-4415-847c-e839a3cb1a04 43734-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20120501 UNAPPROVED MEDICAL GAS Childrens Hospital of Philadelphia OXYGEN 99 L/100L 43734-002_75558d02-53cd-4920-93a9-c0a439873026 43734-002 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20120501 UNAPPROVED MEDICAL GAS Childrens Hospital of Philadelphia OXYGEN 99 L/100L 43742-0001_0b9f4837-441f-4b80-bda2-71d1263e8391 43742-0001 HUMAN OTC DRUG Rheumatism Benzoicum acidum, Pulsatilla, Rhododendron chrysanthum, Spiraea ulmaria, Aconitum napellus, Dulcamara, Euphorbium officinarum, Ledum palustre, Asclepias tuberosa, Lithium benzoicum, LIQUID ORAL 20120405 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITUM NAPELLUS; ASCLEPIAS TUBEROSA ROOT; BENZOIC ACID; EUPHORBIA RESINIFERA RESIN; FILIPENDULA ULMARIA ROOT; LEDUM PALUSTRE TWIG; LITHIUM BENZOATE; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; SOLANUM DULCAMARA FLOWER 4; 6; 3; 4; 3; 4; 8; 3; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0003_d0e8286c-18cb-4407-bc0e-faa7f4451314 43742-0003 HUMAN OTC DRUG Biological Complex II Anthracinum, LIQUID ORAL 20120416 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 30 [hp_C]/mL 43742-0004_de3e55f1-7fb6-4cd2-bdef-a18032eba95e 43742-0004 HUMAN OTC DRUG Heart Small Intestine Meridian Formula Adrenalinum, Coumarinum, Tyramine, Artery (suis), Ascorbicum acidum, Cactus grandiflorus, Co Q 10, Coenzyme A, Cor (suis), Glonoinum, Sarcolacticum acidum, LIQUID ORAL 20120413 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; ASCORBIC ACID; ATROPA BELLADONNA; COENZYME A; CORTICOTROPIN; COUMARIN; DIGITALIS; EPINEPHRINE; GOLD; LACTIC ACID, L-; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; PORK HEART; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SELENICEREUS GRANDIFLORUS STEM; SHIGELLA DYSENTERIAE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ARTERY; SUS SCROFA VEIN; TYRAMINE; UBIDECARENONE 30; 6; 30; 6; 8; 6; 30; 6; 30; 6; 30; 30; 30; 30; 6; 30; 6; 30; 30; 30; 6; 30; 30; 30; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 43742-0005_b3530e74-e556-4fa3-a6d6-e16f9efdbfa5 43742-0005 HUMAN OTC DRUG B Complex Mix Magnesium oroticum, Beta vulgaris, Ascorbicum acidum, Citricum acidum, Cysteinum, Pulsatilla, Adenine, Amygdalin, ATP, Cholinum, Cyanocopalamin, Folic Acid, Insotil, Niacin, p-aminobenzoic acid, Pangamic acid, Panthothenic acid, LIQUID ORAL 20120416 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENINE; ADENOSINE TRIPHOSPHATE; AMINOBENZOIC ACID; AMYGDALIN; ANHYDROUS CITRIC ACID; ASCORBIC ACID; BETA VULGARIS; CHOLINE HYDROXIDE; CYANOCOBALAMIN; CYSTEINE; ESCHERICHIA COLI; FOLIC ACID; INOSITOL; MAGNESIUM OROTATE; MANGANESE PHOSPHATE, DIBASIC; NIACIN; OROTIC ACID MONOHYDRATE; PANGAMIC ACID; PANTOTHENIC ACID; PROTEUS MORGANII; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM DIETHYL OXALACETATE; SULFUR; THIAMINE 6; 6; 6; 6; 4; 3; 2; 6; 6; 4; 30; 6; 6; 12; 10; 6; 8; 6; 6; 30; 4; 6; 6; 7; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0006_96c3d9c7-445f-4132-afe7-1b8b970aad32 43742-0006 HUMAN OTC DRUG Insect Bite Hypericum perforatum, Ledum palustre, Latrodectus mactans, LIQUID ORAL 20110926 UNAPPROVED HOMEOPATHIC Deseret Biologicals CIMEX LECTULARIUS; CITHARACANTHUS SPINICRUS; FORMICA RUFA; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; LOXOSCELES RECLUSA; LYCOPUS VIRGINICUS; LYCOSA TARANTULA; PULEX IRRITANS; THERIDION CURASSAVICUM; VESPA CRABRO 15; 8; 15; 3; 10; 8; 4; 12; 12; 8; 15; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0008_a87c57ed-182d-496e-a16e-1cd50af1dff9 43742-0008 HUMAN OTC DRUG Heart Fatigue Spigelia anthelmia, Kali carbonicum, Arnica montana, Cactus grandiflorus, Gelsemium sempervirens, Castoreum, Glonoinum, Ranunculus bulbosus, Cor suis, Abrotanum, Sulphur, LIQUID ORAL 20120418 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARNICA MONTANA; ARTEMISIA ABROTANUM FLOWERING TOP; CASTOR CANADENSIS SCENT GLAND SECRETION; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; PORK HEART; POTASSIUM CARBONATE; RANUNCULUS BULBOSUS; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; SULFUR 4; 12; 6; 4; 6; 8; 3; 6; 4; 2; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0009_aefff66a-3453-43eb-8ed9-cadabb908145 43742-0009 HUMAN OTC DRUG Geopathic Stress Alfalfa, Laminaria digitata, Symphytum officinale, Calcarea carbonica, Ferrum metallicum, Agate, Iodium, Magnesium metallicum, Manganum metallicum, Quartz, Tarentula cubensis, Cuprum metallicum, Phosphorus, X-ray, Carbon dioxide, Silicea Magnetis polus articus, Magnetis polus australis, LIQUID ORAL 20120419 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALCOHOL, X-RAY EXPOSED (1000 RAD); ALFALFA; CARBON DIOXIDE; CITHARACANTHUS SPINICRUS; COMFREY ROOT; COPPER; IODINE; IRON; LAMINARIA DIGITATA; MAGNESIUM; MANGANESE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SILICON DIOXIDE 30; 3; 30; 15; 3; 30; 12; 8; 3; 12; 12; 8; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0010_e05f9921-4b29-4abd-b3a2-c17697d549bc 43742-0010 HUMAN OTC DRUG Brain Blance Core Formula Acetylcholine chloride, Dopamine, GABA, Octopamine, Serotonin, Taurine, Adenosinum cyclophosphoricum, Cerebrum (suis), Diencephalon (suis), Pineal gland (suis), Thalamus opticus (suis), LIQUID ORAL 20120507 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; ADENOSINE CYCLIC 3',5'-PHOSPHATE; DOPAMINE; OCTOPAMINE; SEROTONIN; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; TAURINE 6; 6; 8; 6; 6; 6; 8; 8; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0011_cd65379c-cc3b-4f58-8daf-f38e4cf7fb24 43742-0011 HUMAN OTC DRUG Lymph Spleen Combo Castanea vesca, Juniperus communis, Phytolacca decandra, Quercus glandium spiritus, Myosotis arvensis, Natrum sulphuricum, Ceanothus americanus, Helianthus annuus, Natrum muriaticum, Lymph (suis), Spleen (suis), Thymus (suis), LIQUID ORAL 20120501 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE; AMBER; APIS MELLIFERA; CASTANEA SATIVA LEAF; CEANOTHUS AMERICANUS LEAF; HELIANTHUS ANNUUS FLOWERING TOP; IRON; JUNIPER BERRY; MYOSOTIS ARVENSIS; PHYTOLACCA AMERICANA ROOT; QUERCUS ROBUR NUT; QUININE ARSENATE; SODIUM CHLORIDE; SODIUM SULFATE; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; UBIDECARENONE 12; 30; 200; 3; 6; 6; 30; 3; 6; 3; 4; 8; 6; 6; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0012_51847da5-4eba-4de9-a5a9-ea8f9d97084c 43742-0012 HUMAN OTC DRUG Multiple Miasm Arsenicum Album, Lycopodium Clavatum, Sulphur, Aloe Socotrina, Carcinosinum, Nitricum Acidum, Silicea, Thuja Occidentalis LIQUID ORAL 20130910 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALOE; ARSENIC TRIOXIDE; HUMAN BREAST TUMOR CELL; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0013_80a53922-5d07-4a0d-97eb-e2d9acece255 43742-0013 HUMAN OTC DRUG Celeragesic Cchinacea, Echinacea purpurea, Hamamelis virginiana, Bellis perennis, Calendula officinalis, Aconitum napellus, Chamomilla, Hypericum perforatum, Belladonna, Millefolium, Bryonia, Rhus toxicodendron, ATP, Coenzyme A, LIQUID ORAL 20120430 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ACTIVATED CHARCOAL; ADENOSINE TRIPHOSPHATE; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS VITALBA FLOWER; COENZYME A; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HELIANTHEMUM NUMMULARIUM FLOWER; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; LACTIC ACID, L-; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; NADIDE; ORNITHOGALUM UMBELLATUM; PROTEUS MORGANII; PRUNUS CERASIFERA FLOWER; SUS SCROFA ADRENAL GLAND; SUS SCROFA THALAMUS; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF; UBIDECARENONE 3; 3; 12; 8; 4; 3; 2; 4; 8; 2; 8; 8; 8; 2; 2; 2; 8; 3; 8; 8; 3; 8; 8; 8; 30; 8; 12; 12; 12; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0014_01d178b0-da9c-498f-8dcb-74d74b2a5fa3 43742-0014 HUMAN OTC DRUG Appetite Control Thyroidinum (suis), Cortisone aceticum, Anacardium orientale, Antimonium crudum, Ignatia amara, Natrum muriaticum, Staphysagria, Cortisol, LIQUID ORAL 20120427 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc ANTIMONY TRISULFIDE; CORTISONE ACETATE; DELPHINIUM STAPHISAGRIA SEED; HYDROCORTISONE; SEMECARPUS ANACARDIUM JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THYROID, PORCINE 15; 12; 18; 30; 15; 15; 15; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0015_8fe80a61-29ee-48b1-a971-df0b05549e66 43742-0015 HUMAN OTC DRUG Biological Complex III Anthracinum, Arsenicum album, Botulinum, Calcarea hypophosphorosa, Coxiella burnetii, Dysentery bacillus, Francisella tularensis, Gaertner bacillus, Kali sulphuricum, Lac caninum, Malaria officinalis, Mutabile bacillus, Pertussinum, Pestinum, Pyrogenium, Typhoid fever, LIQUID ORAL 20120426 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BOTULINUM TOXIN TYPE A; CALCIUM HYPOPHOSPHITE; CANIS LUPUS FAMILIARIS MILK; COXIELLA BURNETII; ESCHERICHIA COLI; FRANCISELLA TULARENSIS; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; PLASMODIUM MALARIAE; POTASSIUM SULFATE; RANCID BEEF; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SHIGELLA DYSENTERIAE; YERSINIA PESTIS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0016_b7b03c69-08db-4cab-b3e2-09380eef250b 43742-0016 HUMAN OTC DRUG Nerve Z Condurango, Echinacea, Ginkgo biloba, Hydrastis canadensis, Myrrha, OSHA, Phytolacca decandra, Tabebuia impetiginosa, Propolis, Glandula suprarenalis suis, Spleen (suis), Thymus (suis), Thyroidinum (suis), Gelsemium sempervirens, LIQUID ORAL 20120502 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; GOLDENSEAL; LIGUSTICUM PORTERI ROOT; LYCOPODIUM CLAVATUM SPORE; MARSDENIA CONDURANGO BARK; MYRRH; PHYTOLACCA AMERICANA ROOT; PROPOLIS WAX; RANCID BEEF; SELENIUM; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; THYROID, PORCINE 3; 12; 3; 3; 3; 12; 3; 3; 3; 6; 30; 12; 12; 8; 8; 8; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0017_ab87ebcf-185d-4d7e-b334-66502b8a7501 43742-0017 HUMAN OTC DRUG Amoeba Baptisia tinctoria, Cajuputum, Capsicum annuum, Fragaria vesca, Frasera, Hamamelis virginiana, Hydrastis canadensis, Quassia amara, Senna, Ipecacuanha, Hepar suis, Pancreas suis, Spleen (suis), Belladonna, Cinchona officinalis, LIQUID ORAL 20120508 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALPINE STRAWBERRY; AMOEBA PROTEUS; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BLASTOCYSTIS HOMINIS; CAJUPUT OIL; CAPSICUM; CINCHONA OFFICINALIS BARK; CRYPTOSPORIDIUM PARVUM; FRASERA CAROLINIENSIS ROOT; FRASERA CAROLINIENSIS ROOT; GIARDIA LAMBLIA; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; IPECAC; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PORK LIVER; QUASSIA AMARA WOOD; QUASSIA AMARA WOOD; SELENIUM; SENNA LEAF; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN 3; 12; 12; 3; 12; 3; 3; 12; 12; 3; 3; 12; 3; 3; 6; 12; 12; 12; 8; 3; 3; 12; 3; 12; 8; 8 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0018_7ccaaeab-857a-4d8b-aeb0-420873faf511 43742-0018 HUMAN OTC DRUG Candida Plus Echinacea, Hydrastis canadensis, Phytolacca decandra, Alternaria tenuis, Aspergillus niger, Geotrichum candidum, Mucor racemosus, Pullularia pullulans, Rhizopus nigra, Acetaldehyde, Caffeic acid, Gallicum acidum, LIQUID ORAL 20120425 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETALDEHYDE; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CAFFEIC ACID; CANDIDA ALBICANS; ECHINACEA, UNSPECIFIED; GALLIC ACID MONOHYDRATE; GEOTRICHUM CANDIDUM; GOLDENSEAL; INDOLE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; MUCOR RACEMOSUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE; YEAST MANNAN 6; 6; 6; 6; 6; 12; 3; 6; 6; 3; 6; 12; 12; 6; 3; 12; 6; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0019_3fced79b-93ef-44f5-a41b-aed3558fbc5c 43742-0019 HUMAN OTC DRUG Allergy Rescue Acetylcholine chloride, Histaminum hydrochloricum, Serotonin, LIQUID ORAL 20120426 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE; HISTAMINE DIHYDROCHLORIDE; SEROTONIN 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0020_85a3a9c6-579a-460e-8724-0aa4c37ad563 43742-0020 HUMAN OTC DRUG Adrenal Support Aralia quinquefolia, Humulus lupulus, Adrenalinum, Cortisone aceticum, Thyroidinum (suis), Selenium metallicum, Arsenicum album, Calcarea carbonica, Convallaria majalis, Crotalus horridus, Ferrum metallicum, Nux vomica, Phosphorus, Sepia, Phosphoricum acidum, LIQUID ORAL 20120502 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMERICAN GINSENG; ARSENIC TRIOXIDE; CONVALLARIA MAJALIS; CORTISONE ACETATE; CROTALUS HORRIDUS HORRIDUS VENOM; EPINEPHRINE; HOPS; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; THYROID, PORCINE 3; 12; 12; 6; 12; 6; 3; 12; 12; 30; 12; 8; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0021_d7ec9161-5f9d-4d10-9051-36e0882dd9f6 43742-0021 HUMAN OTC DRUG Testosterone Testosterone, LIQUID ORAL 20120426 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TESTOSTERONE 6 [hp_X]/mL 43742-0022_f5afb04d-ac1d-405e-b975-265fd6bb5e38 43742-0022 HUMAN PRESCRIPTION DRUG HGH Vitality Agnus Castus, Ambra Grisea, Conium Maculatum, Apiolum, Estradiol, Estriol, Folliculinum, L-Dopa, Melatonin, Testosterone, Alpha-Lipocicum Acidum TABLET ORAL 20120920 UNAPPROVED HOMEOPATHIC Deseret Biologicals .ALPHA.-LIPOIC ACID; ADENOSINE TRIPHOSPHATE; AMBERGRIS; APIOLE (PARSLEY); BARIUM CARBONATE; CHASTE TREE; COENZYME A; CONIUM MACULATUM FLOWERING TOP; ESTRADIOL; ESTRIOL; ESTRONE; LACTIC ACID, L-; LEVODOPA; MELATONIN; NADIDE; PORK LIVER; PROTEUS MORGANII; SELENIUM; SOMATROPIN; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA OVARY; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA TESTICLE; SUS SCROFA UMBILICAL CORD; TESTOSTERONE; UBIDECARENONE 8; 8; 6; 6; 8; 6; 8; 6; 6; 6; 6; 8; 6; 6; 8; 30; 30; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient],Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] 43742-0023_198269f2-95c8-4ac9-a1c7-d5ad4e5c2d54 43742-0023 HUMAN OTC DRUG Upper Respiratory Staph Strep Combination Staphlyococcus Aureus, Klebsiella Pneumoniae, Haemophilus Infulenzae B, Streptococcus Agalactiae, Streptococcus Alpha, TABLET ORAL 20120831 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ENTEROCOCCUS FAECALIS; HAEMOPHILUS INFLUENZAE TYPE B; KLEBSIELLA PNEUMONIAE; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS MUTANS; STREPTOCOCCUS PNEUMONIAE 12; 12; 15; 15; 12; 12; 12 [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 43742-0024_deb59054-4cbc-48ff-aea2-c4daafe895b5 43742-0024 HUMAN OTC DRUG Professional Weight Support Asclepias Vincetoxicum, Echinacea, Hypothalamus (suis), Hepar Suis, Methlycobalamin, Renal (suis), Gambogia TABLET ORAL 20120918 UNAPPROVED HOMEOPATHIC Deseret Biologicals 7-OXO-PRASTERONE; ADENOSINE TRIPHOSPHATE; CYNANCHUM VINCETOXICUM ROOT; ECHINACEA, UNSPECIFIED; GAMBOGE; GLUCAGON; GRAPHITE; INSULIN PORK; LACTIC ACID, L-; METHYLCOBALAMIN; PHYTOLACCA AMERICANA ROOT; PORK KIDNEY; PORK LIVER; PROTEUS VULGARIS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA HYPOTHALAMUS 30; 30; 6; 6; 12; 30; 12; 30; 30; 8; 12; 8; 8; 30; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1 43742-0025_7a1f20e4-1b4f-4ffc-b63f-b678bf6e46f3 43742-0025 HUMAN PRESCRIPTION DRUG Perfect Sleep Adenosine Triphosphate (ATP), Coenzyme A, Coenzyme Q10, Pineal Gland (suis), Sarcolacticum Acidum, Melatonin TABLET ORAL 20120829 UNAPPROVED HOMEOPATHIC Deseret Biologicals ADENOSINE TRIPHOSPHATE; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; COENZYME A; LACTIC ACID, L-; MATRICARIA RECUTITA; MELATONIN; MERCURIC CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; PYRROLE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE; SILICON DIOXIDE; SUS SCROFA PINEAL GLAND; TRYPTOPHAN; UBIDECARENONE; ZINC VALERATE DIHYDRATE 8; 10; 10; 10; 8; 8; 10; 8; 10; 10; 8; 30; 30; 10; 8; 8; 8; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 43742-0026_6300af6c-0aa4-41c8-ac60-11e0f51cf57f 43742-0026 HUMAN PRESCRIPTION DRUG Energise RxS Sarcolacticum Acidum, Viscum Album, Iodium, Colchicum Atumnale, Conium Maculatum, Fucus Vesiculosus, Galiu Aparine, Natrum Oxalaceticum TABLET ORAL 20120926 UNAPPROVED HOMEOPATHIC Deseret Biologicals .ALPHA.-KETOGLUTARIC ACID; ADENOSINE TRIPHOSPHATE; CALCIUM FLUORIDE; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; ESCHERICHIA COLI; FUCUS VESICULOSUS; FUMARIC ACID; GALIUM APARINE; IODINE; LACTIC ACID, L-; LIOTHYRONINE; MALIC ACID; MERCURIC CHLORIDE; PHENYL ISOTHIOCYANATE; PORK LIVER; PRASTERONE; PULSATILLA VULGARIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SODIUM DIETHYL OXALACETATE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA BONE MARROW; SUS SCROFA PINEAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; SUS SCROFA UMBILICAL CORD; THYROID, PORCINE; TYRAMINE; VISCUM ALBUM FRUITING TOP 7; 7; 12; 6; 6; 30; 30; 6; 7; 6; 3; 3; 6; 7; 60; 6; 8; 6; 12; 30; 6; 12; 8; 8; 8; 8; 8; 6; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 43742-0027_a4a7cd1b-71a4-49dd-9100-996c2a6701c8 43742-0027 HUMAN OTC DRUG L Dopa LpDopa, LIQUID ORAL 20120509 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. LEVODOPA 6 [hp_X]/mL 43742-0028_ad1ff17f-1773-42aa-9be9-893717b147db 43742-0028 HUMAN OTC DRUG Tryptophan Tryptophan, LIQUID ORAL 20120509 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TRYPTOPHAN 6 [hp_X]/mL 43742-0029_c9070fc8-d6e1-4b55-ba6e-e9b05d7d57fd 43742-0029 HUMAN OTC DRUG Borrelia Remedy Borrelia burgdorferi, LIQUID ORAL 20120511 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BORRELIA BURGDORFERI 15 [hp_X]/mL 43742-0030_81c2bdb5-47be-4dfa-b3ee-d16c9ae27ca0 43742-0030 HUMAN OTC DRUG Matrix Support Ceanothus americanus, Hydrastis canadensis, Veratrum album, Anacardium orientale, Argentum nitricum, Condurango, Momordica balsamina, Oxalis acetosella, Pulsatilla, Bile duct, (suis), Colon (suis), Duodenum (suis), Esophagus (suis), Eye (suis), Gallbladder (suis), LIQUID ORAL 20120514 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ATROPA BELLADONNA; CEANOTHUS AMERICANUS LEAF; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; MARSDENIA CONDURANGO BARK; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS MONTANA LEAF; PHOSPHORUS; PORK INTESTINE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SHIGELLA DYSENTERIAE; SILVER NITRATE; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; SUS SCROFA JEJUNUM; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; SUS SCROFA RECTUM; SUS SCROFA STOMACH; SUS SCROFA URINARY BLADDER; VERATRUM ALBUM ROOT; WOOD CREOSOTE; YEAST MANNAN 10; 4; 4; 8; 10; 10; 6; 6; 6; 8; 8; 8; 6; 6; 30; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 6; 4; 10; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0031_c2d6dee7-38b6-4b20-a61c-0145d7166305 43742-0031 HUMAN OTC DRUG Systemic Drainage Alfalfa, Avena sativa, Citrus limonum, Glycyrrhiza glabra, Uva-ursi, Taraxacum officinale, Galium aparine, Lobelia inflata, Schisandra chinensis, Solidago virgaurea, Tylophora asthmatica, Berberis vulgaris, Chelidonium majus, Hepar suis, Intestine (suis), LIQUID ORAL 20120510 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALFALFA; ARCTOSTAPHYLOS UVA-URSI LEAF; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; GALIUM APARINE; GLYCYRRHIZA GLABRA; LACTIC ACID, DL-; LACTIC ACID, L-; LEMON JUICE; LOBELIA INFLATA; MAGNESIUM GLUCONATE; PORK INTESTINE; PORK KIDNEY; PORK LIVER; POTASSIUM GLUCONATE; SCHISANDRA CHINENSIS FRUIT; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA LUNG; SUS SCROFA LYMPH; TARAXACUM OFFICINALE; TYLOPHORA INDICA WHOLE; ZINC GLUCONATE 1; 1; 1; 6; 6; 3; 1; 12; 8; 1; 3; 6; 6; 6; 6; 6; 3; 3; 6; 6; 6; 2; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0032_79ae1d23-3319-41ac-ab70-550deba9f01c 43742-0032 HUMAN OTC DRUG Heart Small Intestine Meridian Opener Arsenicum album, Aurum metallicum, Belladonna, Cactus grandiflorus, Cinchona officinalis, Digitalis purpurea, Kali carbonicum, Lithium carbonicum, Lycopodium clavatum, Mercurius solubilis, Naja tripudians, LIQUID ORAL 20120515 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; DIGITALIS; GOLD; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NAJA NAJA VENOM; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; RANCID BEEF; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 43742-0033_77de7c2e-71af-405b-915f-904ff3150eff 43742-0033 HUMAN OTC DRUG Candida 1M Candida albicans, LIQUID ORAL 20120516 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CANDIDA ALBICANS 1 [hp_M]/mL 43742-0034_25aa5299-fca8-4347-8b34-741b45b9ea41 43742-0034 HUMAN OTC DRUG Sinusitis Plus Kali muriaticum, Calcarea sulphurica, Sulphur, Mucor racemosus, Hydrastis canadensis, Kali bichromicum, Lachesis mutus, Mercurius sulphuratus ruber, Hepar sulphuris calcareum, Argentum nitricum, Cobaltum metallicum, Cuprum metallicum, Manganum metallicum, Silicea, Aspergillus fumigatus, LIQUID ORAL 20120516 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; CALCIUM SULFATE ANHYDROUS; CALCIUM SULFIDE; CANDIDA ALBICANS; COBALT; COPPER; GOLDENSEAL; LACHESIS MUTA VENOM; MANGANESE; MERCURIC SULFIDE; MUCOR RACEMOSUS; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; SILICON DIOXIDE; SILVER NITRATE; SINUSITISINUM; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 7; 10; 10; 10; 7; 7; 10; 7; 6; 6; 7; 10; 10; 15; 6; 12 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0035_8347189d-268d-4637-8d36-0c40ab136ff6 43742-0035 HUMAN OTC DRUG Perfect Sleep Adenosine Triphosphate(ATP), Coenzyme A, Coenzyme Q10, Pineal gland (suis), Sarcolacticum acidum, Melatonin, Pyrrole, Tryptophan, Arsenicum album, Avena sativa, Chamomilla, Coffea cruda, Mercurius corrosivus, LIQUID ORAL 20120601 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; COENZYME A; LACTIC ACID, L-; MATRICARIA RECUTITA; MELATONIN; MERCURIC CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; PYRROLE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE; SILICON DIOXIDE; SUS SCROFA PINEAL GLAND; TRYPTOPHAN; UBIDECARENONE; ZINC VALERATE DIHYDRATE 8; 10; 10; 10; 8; 8; 10; 8; 10; 10; 8; 30; 30; 10; 8; 8; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0036_ee119d05-1218-453d-9bf4-969d91d47493 43742-0036 HUMAN OTC DRUG H. Pylori Remedy Helicobacter pylori, LIQUID ORAL 20120517 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HELICOBACTER PYLORI 15 [hp_X]/mL 43742-0037_f44dab5c-515a-4c13-8bc7-3ec53589bf82 43742-0037 HUMAN OTC DRUG FNG Berberis vulgaris, Cochlearia armoracia, Echinacea, Hydrastis canadensis, Lomatium dissectum, Myrrha, Tabebuia impetiginosa, Propolis, Glandula suprarenalis suis, Thymus (suis), Ferrum metallicum, Iridium metallicum Lycopodium clavatum, Phosphoricum acidum, LIQUID ORAL 20120515 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BERBERIS VULGARIS ROOT BARK; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; HORSERADISH; IRIDIUM; IRON; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MUCOR RACEMOSUS; MYRRH; PHOSPHORIC ACID; PROPOLIS WAX; PULSATILLA VULGARIS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; SELENIUM; STACHYBOTRYS CHARTARUM; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; ZINC 12; 12; 12; 3; 12; 12; 3; 3; 3; 12; 12; 3; 12; 12; 3; 12; 6; 12; 12; 12; 12; 12; 8; 8; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0038_4bdc211c-fdc9-4cff-a525-abd83a6d70d2 43742-0038 HUMAN OTC DRUG LYM Arnica montana, Calendula officinalis, Echinacea, Hydrastis canadensis, Myrrha, Phytolacca Decandra, Tarasacum officinale, Trifolium pratense, Trigonella foenum-graecum, Urtica cioica, Propolis, Adrenalinum, Gunpowder, Thymus (suis), Thyroidinum (suis), Arsenicum album, Cocculus indicus, Iridium metallicum, Lycopodium clavatum Phosphorus, LIQUID ORAL 20120517 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACTIVATED CHARCOAL; ANAMIRTA COCCULUS SEED; ARNICA MONTANA; ARSENIC TRIOXIDE; BORRELIA BURGDORFERI; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; EPINEPHRINE; FENUGREEK SEED; GOLDENSEAL; HEPATITIS B VIRUS; IRIDIUM; JAPANESE ENCEPHALITIS VIRUS; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; MYRRH; NEISSERIA MENINGITIDIS; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM NITRATE; PROPOLIS WAX; SULFUR; SUS SCROFA THYMUS; TARAXACUM OFFICINALE; THYROID, PORCINE; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA 8; 12; 3; 12; 15; 3; 3; 8; 3; 3; 33; 12; 15; 30; 12; 3; 30; 12; 3; 8; 6; 8; 8; 3; 8; 12; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0039_bfc06ab8-7bcb-4206-a996-970508f7af8f 43742-0039 HUMAN OTC DRUG Neuro I Hydrastis canadensis, Taraxacum officinale, Dopamine, L-dopa, Melatonin, Serotonin, LIQUID ORAL 20120516 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. DOPAMINE; GOLDENSEAL; LEVODOPA; MELATONIN; SEROTONIN; TARAXACUM OFFICINALE 6; 3; 6; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0050_ada3de83-673a-4e0e-b873-5c147be4a2b0 43742-0050 HUMAN OTC DRUG Circulation Catus grandiflorus, Kali carbonicum, Kalmia latifolia, Arnica montana, Glonoinum, Ignatia amara, Lacticum acidum, Ranunculus bulbosus, Alpha-ketoglutaricum acidum, Arsenicum album, Cor (suis), Fumaricum acidum, Hepar suis, Malic acid, Natrum oxalaceticum, Phosphorus, LIQUID ORAL 20120601 UNAPPROVED HOMEOPATHIC Deseret Biologicals .ALPHA.-KETOGLUTARIC ACID; ACTIVATED CHARCOAL; ARNICA MONTANA; ARSENIC TRIOXIDE; FUMARIC ACID; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 5; KALMIA LATIFOLIA LEAF; LACTIC ACID, DL-; MALIC ACID; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; PORK HEART; PORK LIVER; POTASSIUM CARBONATE; RANUNCULUS BULBOSUS; SELENICEREUS GRANDIFLORUS STEM; SODIUM DIETHYL OXALACETATE; SPIGELIA ANTHELMIA; STROPHANTHUS HISPIDUS SEED; STRYCHNOS IGNATII SEED 8; 12; 6; 8; 8; 17; 17; 4; 6; 8; 15; 6; 8; 8; 8; 4; 6; 3; 8; 10; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0051_049c666e-32e6-436c-a875-0873b7f43430 43742-0051 HUMAN OTC DRUG Enviro II Kali gluconicum, Glandula suprarenalis suis, Hepar suis, Arsenicum album, Iridium metallicum, Phosphorus, Selenium metallicum, Sulphur, Histaminum hydrochloricum, Hyaluronidase, Interferon, Serotonin, LIQUID ORAL 20120606 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACER NEGUNDO POLLEN; AGROSTIS GIGANTEA POLLEN; ALFALFA; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ARSENIC TRIOXIDE; BARLEY; BETULA OCCIDENTALIS POLLEN; BOS TAURUS SKIN; BROWN RICE; CANIS LUPUS FAMILIARIS SKIN; CAPRA HIRCUS SKIN; CARYA OVATA POLLEN; CAVIA PORCELLUS SKIN; CORN GRAIN; DACTYLIS GLOMERATA TOP; DERMATOPHAGOIDES FARINAE; EQUUS CABALLUS SKIN; FAGUS GRANDIFOLIA POLLEN; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; GALLUS GALLUS FEATHER; HISTAMINE DIHYDROCHLORIDE; HOUSE DUST; HYALURONIDASE; INTERFERON .GAMMA. PORCINE RECOMBINANT; IRIDIUM; JUGLANS NIGRA POLLEN; MELOPSITTACUS UNDULATUS FEATHER; MERIONES UNGUICULATUS SKIN; MESOCRICETUS AURATUS SKIN; MILLET; MUS MUSCULUS SKIN; OAT; ORYCTOLAGUS CUNICULUS SKIN; PHLEUM PRATENSE TOP; PHOSPHORUS; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS TOP; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; PORK LIVER; POTASSIUM GLUCONATE; QUERCUS RUBRA POLLEN; RATTUS NORVEGICUS SKIN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS TOP; SALIX NIGRA POLLEN; SELENIUM; SERINUS CANARIA FEATHER; SEROTONIN; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA SKIN; TRIFOLIUM PRATENSE FLOWER; ULMUS AMERICANA POLLEN; WHEAT 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 30; 9; 30; 30; 12; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 9; 9; 9; 8; 6; 9; 9; 9; 9; 9; 12; 9; 30; 9; 12; 8; 9; 9; 9; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0052_3644617a-0bdc-480f-b203-5ce26bb6858a 43742-0052 HUMAN OTC DRUG Inflammation II Asafoetida, Kalmia latifolia, Causticum, Colchicum autumnale, Ferrum metallicum, Gnaphalium polycephalum, Lithium benzoicum, Mercurius praecipitatus ruber, Rhus toxicodendron, Spiraea ulmaria, LIQUID ORAL 20120604 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ASAFETIDA; CAUSTICUM; COLCHICUM AUTUMNALE BULB; FILIPENDULA ULMARIA ROOT; IRON; KALMIA LATIFOLIA LEAF; LITHIUM BENZOATE; MERCURIC OXIDE, YELLOW; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF 8; 10; 10; 10; 10; 8; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0053_31e7e606-b986-4536-b042-969327d6c8c7 43742-0053 HUMAN OTC DRUG Spine and Nerve Balance Core Formula Berberis vulgaris, Cimicifuga racemosa, Cinchona officinalis, Colocynthis, Ledum palustre, Ranunculus bulbosus, Aesculus hippocastanum, Cuprum aceticum, Nadidum, Natrum oxalaceticum, Nicotinamidum, Picricum acidum Pyridoxinum hydrochloricum, LIQUID ORAL 20140306 UNAPPROVED HOMEOPATHIC Deseret Biologicals Inc. .ALPHA.-LIPOIC ACID; AMMONIUM CHLORIDE; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COENZYME A; CUPRIC ACETATE; ENTEROBACTER CLOACAE; HORSE CHESTNUT; LEDUM PALUSTRE TWIG; MERCURIC OXIDE; NADIDE; NIACINAMIDE; PICRIC ACID; PROTEUS MORGANII; PROTEUS VULGARIS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; PYRIDOXINE HYDROCHLORIDE; RANUNCULUS BULBOSUS; RIBOFLAVIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SILICON DIOXIDE; SILVER; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SUS SCROFA UMBILICAL CORD; THIAMINE HYDROCHLORIDE; TRIBASIC CALCIUM PHOSPHATE 8; 8; 4; 4; 4; 4; 10; 6; 30; 6; 4; 10; 6; 6; 6; 30; 30; 10; 6; 4; 6; 30; 8; 10; 6; 28; 10; 10; 8; 8; 10; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0055_df12cfb6-1a66-4393-84fa-fe69df1fa8c5 43742-0055 HUMAN OTC DRUG Polarity Plus Aqua solis, Argentum metallicum, Aurum metallicim, Cuprum metallicum, Lapis albus, Manganum metallicum, Vanadium metallicum, Viscum album, Zincum metallicum LIQUID ORAL 20120607 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CALCIUM HEXAFLUOROSILICATE; COPPER; GOLD; MANGANESE; SILVER; VANADIUM; VISCUM ALBUM FRUITING TOP; WATER; ZINC 1; 1; 1; 1; 1; 1; 1; 30; 1 [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_C]/mL; [hp_M]/mL 43742-0056_c119144a-e992-404e-882d-c270e9043ae0 43742-0056 HUMAN OTC DRUG Post-Dental Visit Chamomilla, Echinacea, Hamamelis virginiana, Hypericum perforatum, Millefolium, Bryonia, Calendula officinalis, Arnica montana, LIQUID ORAL 20120618 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACHILLEA MILLEFOLIUM; ACTIVATED CHARCOAL; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS VITALBA FLOWER; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HELIANTHEMUM NUMMULARIUM FLOWER; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF 3; 12; 4; 6; 6; 4; 8; 4; 8; 3; 3; 8; 3; 8; 3; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0057_79f4ded7-b90c-4165-889e-afe8ca0f2022 43742-0057 HUMAN OTC DRUG Stress EZ Aralia quinquefolia, Ginkgo biloba, Hydrocotyle asiatica, Lomatium dissectum, Cobaltum metallicum, Cuprum metallicum, Gelsemium sempervirens, Iodium, Vanadium metallicum, Star of Bethlehem, Rock Rose, Impatiens, Cherry Plum, Clematis, LIQUID ORAL 20120605 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMERICAN GINSENG; CENTELLA ASIATICA; CLEMATIS VITALBA FLOWER; COBALT; COPPER; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; IODINE; LOMATIUM DISSECTUM ROOT; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER; VANADIUM 3; 3; 30; 12; 12; 12; 3; 30; 30; 12; 3; 30; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 43742-0058_6d9b0abd-75df-418c-a282-0767c11b8815 43742-0058 HUMAN OTC DRUG Taurine Taurine, LIQUID ORAL 20120604 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TAURINE 6 [hp_X]/mL 43742-0059_d8e91658-559c-4d88-a2f5-3279b7c30504 43742-0059 HUMAN OTC DRUG Serotonin Serotonin, LIQUID ORAL 20120604 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SEROTONIN 6 [hp_X]/mL 43742-0060_bd39ef4f-bf9d-4e57-ae0f-94a2488598a4 43742-0060 HUMAN OTC DRUG Thyroplus Fucus vesiculosus, Spongia tosta, Phosphoricum acidum, Pituitary (suis), Thyroidinum (suis), Calcarea carbonica, Iodium, Iridium metallicum, LIQUID ORAL 20120626 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. FUCUS VESICULOSUS; IODINE; IRIDIUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE 3; 12; 12; 12; 6; 4; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0061_3116da5a-0ca6-4b3c-90dd-59c51cc0256b 43742-0061 HUMAN OTC DRUG Detox I Carduus marianus, Chelidonium majus, Cinchona officinalis, Lycopodium clavatum, Taraxacum officinale, Veratrum album, Avena sativa, Cynara scolymus, Methylcobalamin, Menadione, a-Lipoicum acidum, Hepar suis, LIQUID ORAL 20120629 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; AVENA SATIVA FLOWERING TOP; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; FORMIC ACID; GLYOXAL; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; MALIC ACID; MENADIONE; METHYLCOBALAMIN; OROTIC ACID MONOHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK INTESTINE; PORK LIVER; PROTEUS MORGANII; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SILYBUM MARIANUM SEED; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA GALLBLADDER; SUS SCROFA LYMPH; SUS SCROFA PANCREAS; SUS SCROFA THYMUS; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOT 10; 8; 6; 4; 10; 4; 6; 10; 10; 10; 4; 10; 6; 6; 7; 28; 8; 8; 30; 30; 3; 10; 13; 8; 8; 8; 8; 8; 8; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0062_078bf584-2231-4507-a3ce-e82728e68fa0 43742-0062 HUMAN OTC DRUG Detox III Conium maculatum, Dulcamara, Echinacea, Aesculus hippocastanum, Antimonium tartaricum, Ascorbicum acidum, Coccus cacti, Galium aparine, Gentiana lutea, Geranium robertianum, Lymph (suis), Sulphur, Glandula suprarenalis suis, Phenylalanine, Calcarea phosphorica, LIQUID ORAL 20120628 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; BARIUM CARBONATE; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; ECHINACEA, UNSPECIFIED; ESCHERICHIA COLI; FERROSOFERRIC PHOSPHATE; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; HORSE CHESTNUT; LACTIC ACID, L-; LIOTHYRONINE; MERCURIUS SOLUBILIS; PHENYLALANINE; PORK LIVER; PROTORTONIA CACTI; PULSATILLA VULGARIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA TONSIL; SUS SCROFA UMBILICAL CORD; TRIBASIC CALCIUM PHOSPHATE 6; 6; 28; 4; 13; 4; 30; 10; 6; 6; 6; 6; 6; 10; 13; 8; 10; 6; 6; 9; 4; 8; 8; 12; 10; 8; 10; 6; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 43742-0063_6836b4d6-4aeb-4815-a2ca-358e99ef1178 43742-0063 HUMAN OTC DRUG Coumarin Coumarinum, LIQUID ORAL 20120627 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. COUMARIN 6 [hp_X]/mL 43742-0064_32eea969-e76a-4e3d-a9b3-77a024ec104d 43742-0064 HUMAN OTC DRUG Chemtox Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense, Glandula Suprarenalis Suis LIQUID ORAL 20120629 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETIC ACID; ARCTIUM LAPPA ROOT; ASPIRIN; ATROPA BELLADONNA; BENZOIC ACID; BENZYL ALCOHOL; BERBERIS VULGARIS ROOT BARK; BORIC ACID; CHLORINE; CORTICOTROPIN; CORTISONE ACETATE; ESTRONE; EUGENOL; GLYCYRRHIZA GLABRA; IRIDIUM; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LEAD; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PETROLATUM; PHENYLBUTAZONE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PORK LIVER; POTASSIUM SORBATE; RESORCINOL; SELENIUM; SORBITOL; STEARYL ALCOHOL; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; THYROID, PORCINE; TRIFOLIUM PRATENSE FLOWER; XYLITOL 30; 3; 30; 12; 30; 30; 3; 30; 30; 30; 30; 30; 30; 3; 12; 30; 30; 30; 12; 12; 30; 30; 12; 3; 8; 30; 30; 12; 30; 30; 3; 12; 8; 8; 8; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0065_5a4fbe01-d540-4339-8788-6edb44d65da1 43742-0065 HUMAN OTC DRUG Enviro I Kali gluconate, Glandula suprarenalis suis, Hepar suis, Coffea tosta, Thea sinensis, Carbo vegetabilis Ferrum iodatum, Ferrum metallicum, Gelsemium sempervirens, Iodium, Iridium metallicum, Lycopodium clavatum, Pulsatilla, Selenium metallicum, LIQUID ORAL 20120702 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACTIVATED CHARCOAL; ALPINE STRAWBERRY; BANANA; BARLEY; BEEF; BITTER ALMOND; BLACK PEPPER; BLACK WALNUT; BRAZIL NUT; BROWN RICE; CASEIN, STREPTOCOCCUS THERMOPHILUS CULTURED, PROPIONIBACTERIUM FREUDENREICHII SUBSP. SHERMANII CULTURED, AGED; CASHEW; CHICKEN; COCOA; COCONUT; COFFEA ARABICA SEED, ROASTED; CORN; CORTISONE ACETATE; COW MILK; EGG; EGGPLANT; ENGLISH WALNUT; ESCHSCHOLZIA CALIFORNICA; FERROUS IODIDE; FLAX SEED; GELSEMIUM SEMPERVIRENS ROOT; GREEN TEA LEAF; HISTAMINE DIHYDROCHLORIDE; HYALURONIDASE; INTERFERON .GAMMA. PORCINE RECOMBINANT; IODINE; IRIDIUM; IRON; KIDNEY BEAN; LAMB; LEVANT COTTON SEED; LIMULUS POLYPHEMUS; LOPHATHERUM GRACILE LEAF; LYCOPODIUM CLAVATUM SPORE; MALUS DOMESTICA FLOWER; MILLET; OAT; ONION; ORANGE; OYSTER, UNSPECIFIED; PACIFIC COD; PEANUT; PECAN; PORK; PORK LIVER; POTASSIUM GLUCONATE; POTATO; PULSATILLA VULGARIS; RYE; SAFFLOWER; SALMON, UNSPECIFIED; SELENIUM; SEROTONIN; SESAME SEED; SHRIMP, UNSPECIFIED; SORGHUM; SORGHUM BICOLOR WHOLE; SOYBEAN; SUGARCANE; SUNFLOWER SEED; SUS SCROFA ADRENAL GLAND; TOMATO; TUNA, UNSPECIFIED; WHEAT; ZINC 12; 12; 12; 9; 12; 12; 12; 12; 12; 9; 12; 12; 12; 10; 12; 10; 9; 30; 12; 12; 12; 12; 9; 12; 9; 12; 10; 30; 30; 12; 12; 12; 12; 12; 12; 9; 12; 9; 12; 12; 9; 9; 12; 12; 12; 12; 12; 12; 12; 8; 8; 12; 12; 9; 9; 12; 12; 30; 9; 12; 9; 9; 9; 9; 9; 8; 12; 12; 9; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0066_ae87ac4e-6aaa-431e-878c-d346e59536f6 43742-0066 HUMAN OTC DRUG Estrogen Folliculinum, Oophorinum, LIQUID ORAL 20120710 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ESTRONE; SUS SCROFA OVARY 8; 8 [hp_X]/mL; [hp_X]/mL 43742-0067_15a88916-91d1-45ca-a001-9bcad39e7d5d 43742-0067 HUMAN OTC DRUG Headache Cimicifuga racemosa, Gelsemium sempervirens, Rhus toxicodendron, LIQUID ORAL 20120710 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON PUBESCENS LEAF 2; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0068_1810cc97-9746-48bc-b8d1-11f00953e7e2 43742-0068 HUMAN OTC DRUG Lymphoplus Trifolium pratense, Lymph (suis), Spleen (suis), Conium maculatum, Echinacea, Lycopodium clavatum, Myrrha, Phytolacca decandra, Selenium metallicum, Silicea, LIQUID ORAL 20120711 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; LYCOPODIUM CLAVATUM SPORE; MYRRH; PHYTOLACCA AMERICANA ROOT; SELENIUM; SILICON DIOXIDE; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; TRIFOLIUM PRATENSE FLOWER 12; 12; 12; 12; 12; 12; 12; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0069_80f1cceb-56d1-414d-b7a7-00ac5f6031b2 43742-0069 HUMAN OTC DRUG Metab Ascorbicum acidum, Cysteinum, Manganum gluconate, Alpha-ketoglutaricum acidum, Fumaricum acidum, Germainum sesquioxide, Iodium, Magnesium metallicum, Natrum oxalaceticum, Pulsatilla, Thyroidinum (suis), Vanadium metallicum, LIQUID ORAL 20120710 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-KETOGLUTARIC ACID; ASCORBIC ACID; CYSTEINE; FUMARIC ACID; GERMANIUM SESQUIOXIDE; IODINE; MAGNESIUM; MANGANESE GLUCONATE; PULSATILLA VULGARIS; SODIUM DIETHYL OXALACETATE; THYROID, PORCINE; VANADIUM 12; 6; 9; 12; 12; 12; 12; 10; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0070_7841b163-098f-43be-9314-6c5ef398551a 43742-0070 HUMAN OTC DRUG Pericardium Triple Warmer Meridian Formula Norepinephrine, Octopamine, Insulin, Hydrocortisone, Ascorbicum acidum, Glandula suprarenalis suis, Heart (suis) LIQUID ORAL 20120910 UNAPPROVED HOMEOPATHIC Deseret Biologicals ARSENIC TRIOXIDE; ASCORBIC ACID; BARIUM CARBONATE; CORTICOTROPIN; GOLD; HYDROCORTISONE; INSULIN PORK; IODINE; LACHESIS MUTA VENOM; LACTIC ACID, L-; LITHIUM CARBONATE; LOBELIA INFLATA; MERCURIUS SOLUBILIS; NAJA NAJA VENOM; NITROGLYCERIN; NOREPINEPHRINE; OCTOPAMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; PORK HEART; POTASSIUM IODIDE; PROTEUS MORGANII; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SEPIA OFFICINALIS JUICE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE; UBIDECARENONE 30; 6; 30; 8; 30; 6; 15; 30; 30; 6; 30; 30; 30; 30; 30; 6; 6; 30; 30; 30; 6; 30; 30; 8; 30; 30; 6; 6; 6; 8 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0071_2cbc52f7-c1ef-4b6f-851a-177ce1160c63 43742-0071 HUMAN OTC DRUG Cerebromax Acetylcholine Chloride, Adrenalinum, Dopamine, Gaba, Norepinephrine, Octopamine, Serotonin, Taurine LIQUID ORAL 20120815 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; ADENOSINE CYCLIC 3',5'-PHOSPHATE; DOPAMINE; EPINEPHRINE; NOREPINEPHRINE; OCTOPAMINE; SEROTONIN; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; TAURINE 6; 6; 8; 6; 6; 6; 6; 6; 8; 8; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0072_3f5cf3a0-e78d-49ea-9a89-51b6d98b59ec 43742-0072 HUMAN OTC DRUG Spinalmax Berberis vulgaris, Cimicifuga racemosa, Cinchona officinalis, Colocynthis, Ledum palustre, Ranunculus bulbosus, Aesculus hippocastanum, Cuprum aceticum, LIQUID ORAL 20140402 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-LIPOIC ACID; AMMONIUM CHLORIDE; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COENZYME A; CUPRIC ACETATE; ENTEROBACTER CLOACAE; HORSE CHESTNUT; LEDUM PALUSTRE TWIG; MERCURIC OXIDE; NADIDE; NIACINAMIDE; PICRIC ACID; PROTEUS MORGANII; PROTEUS VULGARIS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; PYRIDOXINE HYDROCHLORIDE; RANUNCULUS BULBOSUS; RIBOFLAVIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SILICON DIOXIDE; SILVER; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SUS SCROFA UMBILICAL CORD; THIAMINE HYDROCHLORIDE; TRIBASIC CALCIUM PHOSPHATE 8; 8; 4; 4; 4; 4; 10; 6; 30; 6; 4; 10; 6; 6; 6; 30; 30; 10; 6; 4; 6; 30; 8; 10; 6; 28; 10; 10; 8; 8; 10; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0073_892a1b71-281c-4cf9-a226-45b76b6c7a24 43742-0073 HUMAN OTC DRUG Detox II Solidago virgaurea, Baptisia tinctoria, Berberis vulgaris, Equisetum hyemale, Argentum nitricum, Cantharis, Capsicum annuum, Cuprum sulphuricum, Orthosiphon stamineus, Pareira brava, Sarsaparilla, Terebinthina, Apis venenum purum, Barosma, Mercurius corrosivus, LIQUID ORAL 20120710 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AGATHOSMA BETULINA LEAF; APIS MELLIFERA VENOM; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CAPSICUM; CHONDRODENDRON TOMENTOSUM ROOT; CLERODENDRANTHUS SPICATUS LEAF; CUPRIC SULFATE; EQUISETUM HYEMALE; ESCHERICHIA COLI; GLYOXAL TRIMER DIHYDRATE; LYTTA VESICATORIA; MERCURIC CHLORIDE; QUERCETIN; SHIGELLA DYSENTERIAE; SILVER NITRATE; SMILAX REGELII ROOT; SODIUM PYRUVATE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA URETHRA; SUS SCROFA URINARY BLADDER; TURPENTINE OIL 8; 8; 4; 4; 10; 6; 6; 6; 6; 4; 15; 10; 6; 8; 10; 30; 6; 6; 10; 3; 8; 8; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0074_002df6ca-2a68-4894-9e6f-a48062b8f694 43742-0074 HUMAN OTC DRUG Liver Drainage Berberis vulgaris, Chelidonium majus, Carduus marianus, Schisandra chinensis, Taraxacum officinale, Picrorhiza scrophulariiflora, Raphanus sativus, Viscum album, Chromium gluconate, Cobaltum gluconate, Copper gluconate, Magnesium gluconate, Natrum sulphuricum, LIQUID ORAL 20120711 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; CHROMIUM GLUCONATE; CICHORIUM INTYBUS FLOWER; COBALTOUS GLUCONATE; COPPER GLUCONATE; LACTIC ACID, L-; MAGNESIUM GLUCONATE; NEOPICRORHIZA SCROPHULARIIFLORA ROOT; PHENOL; PORK LIVER; PTELEA TRIFOLIATA BARK; RADISH; SCHISANDRA CHINENSIS FRUIT; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SULFUR IODIDE; SUS SCROFA GALLBLADDER; SUS SCROFA PANCREAS; TARAXACUM OFFICINALE; VANADIUM; VERBENA OFFICINALIS FLOWERING TOP; VISCUM ALBUM FRUITING TOP 1; 1; 6; 8; 6; 6; 6; 6; 3; 8; 8; 6; 3; 2; 2; 6; 8; 6; 8; 8; 2; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0085_79f9b7c4-eb76-4c4f-bb99-803d4b617b0f 43742-0085 HUMAN OTC DRUG Gum Therapy Calendula officinalis, Eugenia caryophyllata, Plantago major, Phytolacca decandra, Arnica montana, Phosphorus, Peptostreptococcus, LIQUID ORAL 20120803 UNAPPROVED HOMEOPATHIC Deseret Biologicals ACTIVATED CHARCOAL; ARNICA MONTANA; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CLOVE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PEPTOSTREPTOCOCCUS ANAEROBIUS; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR 30; 3; 30; 1; 1; 30; 30; 15; 12; 2; 1 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0086_751e9ef9-c392-49ba-bded-5c974b085d7a 43742-0086 HUMAN OTC DRUG Histamine Histaminum Hydrochloricum LIQUID ORAL 20120816 UNAPPROVED HOMEOPATHIC Deseret Biologials, Inc. HISTAMINE DIHYDROCHLORIDE 6 [hp_X]/mL 43742-0087_2b05add1-6582-4f75-9691-a27801819ea1 43742-0087 HUMAN OTC DRUG Intestinal Distress Echinacea, Colchicum Autumnale, Aloe Socotrina, Colocynthis, Mercurius Corrosivus, Nux Vomica, Arsenicum Album LIQUID ORAL 20120821 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALOE; ARSENIC TRIOXIDE; BOTULINUM TOXIN TYPE A; CAMPYLOBACTER JEJUNI; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; ECHINACEA ANGUSTIFOLIA; ESCHERICHIA COLI; HELICOBACTER PYLORI; MERCURIC CHLORIDE; QUININE SULFATE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SHIGELLA DYSENTERIAE; STRYCHNOS NUX-VOMICA SEED; VIBRIO CHOLERAE; YERSINIA ENTEROCOLITICA 6; 6; 30; 30; 6; 4; 3; 30; 30; 6; 12; 15; 33; 30; 6; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0088_f9e47d09-bf08-4eeb-9459-aa0e16b1b764 43742-0088 HUMAN OTC DRUG Phenylalanine Phenylalanine LIQUID ORAL 20120816 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PHENYLALANINE 6 [hp_X]/mL 43742-0089_6fd4383c-a181-46cf-9a6e-3476b25aa495 43742-0089 HUMAN OTC DRUG Virus Echinacea, Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Spleen, Thymus LIQUID ORAL 20120815 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; IODINE; LACHESIS MUTA VENOM; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MYRRH; NASTURTIUM AQUATICUM; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; SELENIUM; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; ZINC 12; 12; 3; 12; 12; 3; 12; 12; 3; 12; 3; 3; 12; 12; 30; 12; 12; 8; 8; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0090_0e375402-a572-4157-9872-9145d4d52146 43742-0090 HUMAN OTC DRUG Lymph Drainage Citrus Limonum, Echinacea, Scrophularia Nodosa, Teucrium Scorodonia, Baptisia Tinctoria, Lobelia Inflata, Phytolacca Decandra LIQUID ORAL 20120821 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARANEUS DIADEMATUS; ARSENIC TRIIODIDE; BAPTISIA TINCTORIA; CAPSICUM; CARPINUS BETULUS FLOWER; CENTAURIUM ERYTHRAEA; COPPER GLUCONATE; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; LARIX DECIDUA FLOWERING TOP; LEMON JUICE; LOBELIA INFLATA; MAGNESIUM GLUCONATE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; SCROPHULARIA NODOSA; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; ZINC GLUCONATE 8; 8; 1; 6; 8; 8; 6; 1; 12; 8; 1; 3; 6; 3; 3; 1; 8; 8; 8; 1; 4; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0091_a0749d05-4d4b-422f-90ca-9fe874620baf 43742-0091 HUMAN OTC DRUG Candida 200C Candida Albicans LIQUID ORAL 20120822 UNAPPROVED HOMEOPATHIC DeseretBiolgicals, Inc CANDIDA ALBICANS 200 [hp_C]/mL 43742-0092_709a9dff-4116-49fd-a8c8-b08fadeb5ba2 43742-0092 HUMAN OTC DRUG Energize RxS Sarcolacticum acidum, Viscum album, Iodium, Colchicum autumnale, Conium maculatum, Fucus vesiculosus, Galium aparine, Natrum oxalaceticum, Thyroidinum (suis), LIQUID ORAL 20120807 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-KETOGLUTARIC ACID; ADENOSINE TRIPHOSPHATE; CALCIUM FLUORIDE; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; ESCHERICHIA COLI; FUCUS VESICULOSUS; FUMARIC ACID; GALIUM APARINE; IODINE; LACTIC ACID, L-; LIOTHYRONINE; MALIC ACID; MERCURIC CHLORIDE; PHENYL ISOTHIOCYANATE; PORK LIVER; PRASTERONE; PULSATILLA VULGARIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SODIUM DIETHYL OXALACETATE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA BONE MARROW; SUS SCROFA PINEAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; SUS SCROFA UMBILICAL CORD; THYROID, PORCINE; TYRAMINE; VISCUM ALBUM FRUITING TOP 7; 7; 12; 6; 6; 30; 30; 6; 7; 6; 3; 3; 6; 7; 60; 6; 8; 6; 12; 30; 6; 12; 8; 8; 8; 8; 8; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0095_89a6cbc2-97b9-4ed4-83ad-ce6d0b954f61 43742-0095 HUMAN OTC DRUG Allermilk Hydrastis Canadensis, Taraxacum Officinale, Apiolum, Asparagine, Benzoicum Acidum, Cholinum, Cinnamic Acidum LIQUID ORAL 20120822 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .GAMMA.-AMINOBUTYRIC ACID; APIOLE (PARSLEY); ASPARAGINE; BENZOIC ACID; CHOLINE HYDROXIDE; CINNAMIC ACID; COUMARIN; ESTRONE; EUGENOL; FOLIC ACID; FORMALDEHYDE; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; LACTOSE; MENADIONE; OCTOPAMINE; PHENYL ISOTHIOCYANATE; PIPERINE; PROGESTERONE; QUERCETIN; RUTIN; SUS SCROFA OVARY; TARAXACUM OFFICINALE; VANILLYLAMINE; XANTHINE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 3; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0096_c6dcf576-04ef-43fb-a3e2-d1ccf12749a9 43742-0096 HUMAN OTC DRUG Energy Catalyst Viscum Album, Cobaltum Gluconicum, Cuprum Sulphuricum, Ferrous Fumaricum, Kali Asparaginicum, Magnesia Asparaginicum, Manganum Gluconicum LIQUID ORAL 20120823 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE CYCLIC 3',5'-PHOSPHATE; ALUMINUM; ALUMINUM OXIDE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CEROUS OXALATE NONAHYDRATE; CESIUM CHLORIDE; CHOLECALCIFEROL; CHROMIUM; COBALT; COBALTOUS GLUCONATE; COPPER; CUPRIC SULFATE; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; FERROUS FUMARATE; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; IRIDIUM; IRON; LANTHANUM OXIDE; LEAD; LITHIUM CARBONATE; MAGNESIUM; MAGNESIUM ASPARAGINATE; MANGANESE; MANGANESE GLUCONATE; MERCURIC CHLORIDE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NICKEL ACETATE TETRAHYDRATE; NIOBIUM; OSMIUM; PALLADIUM; PHOSPHORUS; PLATINUM; POTASSIUM ASPARAGINATE; PRASEODYMIUM; PROTEUS MORGANII; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; SILVER; SODIUM MOLYBDATE; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; TIN; URANYL NITRATE HEXAHYDRATE; VANADIUM; VISCUM ALBUM FRUITING TOP; YTTERBIUM OXIDE; ZINC 8; 12; 30; 12; 12; 12; 12; 12; 12; 12; 12; 12; 8; 12; 8; 12; 12; 6; 12; 6; 12; 12; 12; 6; 12; 12; 12; 12; 12; 12; 12; 200; 12; 12; 6; 12; 6; 30; 12; 12; 12; 12; 8; 12; 12; 12; 6; 12; 6; 12; 30; 12; 12; 12; 12; 12; 6; 12; 12; 12; 12; 12; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0097_e59e1bc8-e6b8-4d9f-a5a2-41ed5084b04e 43742-0097 HUMAN OTC DRUG Enviroclenz Berberis Vulgaris, Carduus Marianus, Chelidonium Majus, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula, LIQUID ORAL 20120822 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETONE; AMMONIUM CHLORIDE; ARCTIUM LAPPA ROOT; ATROPA BELLADONNA; BENZENE; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; CHLORINE; FRANGULA ALNUS BARK; GERMANIUM SESQUIOXIDE; GLYCYRRHIZA GLABRA; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; METHYL ALCOHOL; NITRIC ACID; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PROPYLENE GLYCOL; SILYBUM MARIANUM SEED; SODIUM BENZENESULFONATE; SODIUM LAURYL SULFATE; SODIUM TRIPOLYPHOSPHATE; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; TURPENTINE OIL 9; 9; 3; 12; 9; 3; 3; 9; 3; 8; 3; 12; 12; 9; 12; 12; 3; 9; 3; 9; 9; 9; 3; 12; 3; 3; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0098_d4e729d2-2673-42fc-9742-f77ab09af53c 43742-0098 HUMAN OTC DRUG Focus RxS Alpha-Ketoglutaricum Acidum, ATP, Formicum Acidum, Malicum Acidum, Sarocolacticum Acidum LIQUID ORAL 20120827 UNAPPROVED HOMEOPATHIC Deseret Biologicals .ALPHA.-KETOGLUTARIC ACID; .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; ADENOSINE CYCLIC 3',5'-PHOSPHATE; ADENOSINE TRIPHOSPHATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; DOPAMINE; EPINEPHRINE; FORMIC ACID; HYOSCYAMUS NIGER; JUNIPERUS SABINA LEAFY TWIG; LACTIC ACID, L-; LYCOSA TARANTULA; MALIC ACID; NOREPINEPHRINE; OCTOPAMINE; PHENETHYLAMINE; PHOSPHORUS; PORK BRAIN; SEROTONIN; SHIGELLA DYSENTERIAE; SILICON DIOXIDE; SOLANUM DULCAMARA FLOWER; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA BRAINSTEM; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; TAURINE; TYRAMINE; VALERIAN; VERATRUM ALBUM ROOT 6; 6; 6; 8; 6; 30; 30; 6; 6; 6; 6; 6; 6; 30; 6; 6; 6; 6; 6; 8; 6; 30; 8; 6; 30; 8; 8; 8; 8; 8; 6; 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 43742-0099_44064b27-ba30-4193-a198-45ebeae94031 43742-0099 HUMAN OTC DRUG Hydration Complex Beta Vulgaris, Boldo, Carduus Benedictus, Chelidonium Majus, Coffea Tosta, Equisetum Arvense, Petroselinum Sativum LIQUID ORAL 20120824 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETA VULGARIS; CALCIUM FLUORIDE; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; COFFEA ARABICA SEED, ROASTED; EQUISETUM ARVENSE TOP; GERMANIUM SESQUIOXIDE; GINKGO; HYPERICUM PERFORATUM; PETROSELINUM CRISPUM; PEUMUS BOLDUS LEAF; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; SILICON DIOXIDE; TARAXACUM OFFICINALE; TRIBASIC CALCIUM PHOSPHATE 1; 8; 1; 1; 1; 1; 8; 6; 3; 1; 1; 6; 6; 6; 8; 1; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0100_89a081dc-16ec-4768-9052-72784e5ec170 43742-0100 HUMAN OTC DRUG Neuro II Hydrastis Canadensis, Taraxacum Officinale, Acetylcholine Chloride, Adrenalinum, Gaba, Histaminum Hydrochloricum LIQUID ORAL 20120824 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; EPINEPHRINE; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; NOREPINEPHRINE; TARAXACUM OFFICINALE; TYRAMINE 6; 6; 6; 3; 6; 6; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0101_a4192fe2-4508-411f-a95b-2128e91f0fdb 43742-0101 HUMAN OTC DRUG Norepinephrine Norepinephrine LIQUID ORAL 20120824 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. NOREPINEPHRINE 6 [hp_X]/mL 43742-0102_fad13c6f-30b3-435f-a11e-814bfd2f9ef5 43742-0102 HUMAN OTC DRUG Professional Weight Support Asclepias Vincetoxicum, Echinacea, Hypothlamus (Suis), Hepar Suis, Methylcobalamin, Renal (Suis), Gambogia LIQUID ORAL 20120823 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. 7-OXO-PRASTERONE; ADENOSINE TRIPHOSPHATE; CYNANCHUM VINCETOXICUM ROOT; ECHINACEA, UNSPECIFIED; GAMBOGE; GLUCAGON; GRAPHITE; INSULIN PORK; LACTIC ACID, L-; METHYLCOBALAMIN; PHYTOLACCA AMERICANA ROOT; PORK KIDNEY; PORK LIVER; PROTEUS INCONSTANS; PROTEUS INCONSTANS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA HYPOTHALAMUS 30; 30; 6; 6; 12; 30; 12; 30; 30; 8; 12; 8; 8; 30; 30; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43742-0103_56f1cc34-f085-49f5-a2b9-6c606a3220c7 43742-0103 HUMAN OTC DRUG Systemic Detox Beta Vulgaris, Boldo, Chelidonium Majus, Sarsaparilla, Gelsemium Sempervirens, Veratrum Album, Ferrum Metallicum LIQUID ORAL 20120827 UNAPPROVED HOMEOPATHIC Deseret Biologicals BETA VULGARIS; CHELIDONIUM MAJUS; GELSEMIUM SEMPERVIRENS ROOT; IODINE; IRON; LYCOPODIUM CLAVATUM SPORE; PEUMUS BOLDUS LEAF; PULSATILLA VULGARIS; SARSAPARILLA; SELENIUM; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT; ZINC 3; 3; 7; 12; 12; 12; 3; 12; 6; 12; 12; 12; 7; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0104_e4a1f4f8-13c8-4688-9ae9-8ae0244d4cc5 43742-0104 HUMAN OTC DRUG Metox Allium Sativum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense LIQUID ORAL 20120824 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALUMINUM OXIDE; ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; ASCORBIC ACID; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BERYLLIUM; BISMUTH; BORON; CADMIUM; CERIUM; CHROMIUM; COBALT; COPPER; CYSTEINE; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; FORMALDEHYDE; GADOLINIUM OXIDE; GARLIC; GERMANIUM SESQUIOXIDE; GLYCYRRHIZA GLABRA; GOLD; HOLMIUM; IRIDIUM; IRON; LANTHANUM OXIDE; LEAD; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM; MANGANESE; MERCURIC CHLORIDE; MERCURIUS SOLUBILIS; METHIONINE; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PHENOL; PHYTOLACCA AMERICANA ROOT; PLATINUM; PRASEODYMIUM; PROTEUS MORGANII; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; SODIUM CHLORIDE; STILLINGIA SYLVATICA ROOT; STRONTIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; TANTALUM; TERBIUM; THALLIUM; THYROID, PORCINE; TIN; TRIFOLIUM PRATENSE FLOWER; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC 12; 12; 3; 12; 6; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12; 6; 12; 12; 12; 12; 12; 3; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 8; 12; 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 12; 8; 12; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0105_ede42f83-e0e7-47d5-99f1-19733f6a1414 43742-0105 HUMAN OTC DRUG Formaldehyde Formalinum LIQUID ORAL 20121228 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. FORMALDEHYDE 6 [hp_X]/mL 43742-0130_d6b4c68c-176f-4586-8f9d-630c8c548c94 43742-0130 HUMAN OTC DRUG Sinusitis Pulsatilla, Plantago Major, Euphorbium Officinarum, Luffa Operculata, Mercurius Iodatus Ruber, Mucosa Nasalis Suis, Argentum Nitricum LIQUID ORAL 20120906 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CALCIUM SULFIDE; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILVER NITRATE; SINUSITISINUM; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA 10; 4; 6; 8; 12; 3; 2; 10; 18; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0131_3529dad8-218d-4ea0-bc97-52c0d4b0e810 43742-0131 HUMAN PRESCRIPTION DRUG Tobacco Avena Sativa, Lobelia Inflata, Cactus Grandiflorus, Tabacum, Gelsemium Sempervirens, Selenium Metallicum, Staphysagria LIQUID ORAL 20120920 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AVENA SATIVA FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; LOBELIA INFLATA; SELENICEREUS GRANDIFLORUS STEM; SELENIUM; TOBACCO LEAF; VANADIUM 1; 12; 12; 3; 4; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 43742-0132_0f71e1d0-5e50-472c-8398-afc11714d3d8 43742-0132 HUMAN OTC DRUG EBV Baptisia Tinctoria, Condurango, Echinacea, Hydrastis Canadensis, Nasturtium Aquaticum, Osha, Phytolacca Decandra LIQUID ORAL 20120910 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARANEUS DIADEMATUS; ASTRAGALUS NUTTALLII LEAF; BAPTISIA TINCTORIA; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HUMAN HERPESVIRUS 4; HYDROCHLORIC ACID; IPECAC; LIGUSTICUM PORTERI ROOT; LYCOPODIUM CLAVATUM SPORE; MARSDENIA CONDURANGO BARK; MERCURIUS SOLUBILIS; NASTURTIUM AQUATICUM; NITRIC ACID; PHYTOLACCA AMERICANA ROOT; PROPOLIS WAX; SELENIUM; SILICON DIOXIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; TOXICODENDRON PUBESCENS LEAF 12; 6; 3; 3; 12; 3; 30; 12; 12; 3; 12; 3; 12; 3; 12; 3; 6; 12; 12; 8; 8; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0133_1f7d0ee0-7375-49cc-bdda-8db2d4b3cd3a 43742-0133 HUMAN OTC DRUG Arthritis Joints Gnaphalium Polycephalum, Berberis Vulgaris, Cimicifuga Racemosa, Cinchona Officinalis, Colocynthis, Ledum Palustre, Ranunculus Bulbosus LIQUID ORAL 20120912 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMMONIUM CHLORIDE; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CLAVICEPS PURPUREA SCLEROTIUM; CUPRIC ACETATE; HORSE CHESTNUT; LEDUM PALUSTRE TWIG; MERCURIC OXIDE, YELLOW; PALLADIUM; PICRIC ACID; POTASSIUM CARBONATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER; SODIUM BORATE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; TRIBASIC CALCIUM PHOSPHATE; ZINC 8; 4; 4; 4; 4; 6; 6; 6; 4; 10; 12; 12; 6; 3; 6; 4; 10; 8; 10; 6; 30; 10; 12; 12; 12; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43742-0134_13eaeb90-7b6f-4373-8dbc-337adbbce078 43742-0134 HUMAN OTC DRUG Asthma Plus Ribes Nigrum, Viburnum Opulus, Quebracho, Arsenicum Iodatum, Blatta Orientalis, Naphtalinum, Pothos Foetidus LIQUID ORAL 20120910 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIIODIDE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; BLACK CURRANT; BLATTA ORIENTALIS; CINNAMIC ACID; COUMARIN; DERMATOPHAGOIDES FARINAE; GALLIC ACID; INDOLE; MALVIN; NAPHTHALENE; OXYGEN; QUERCETIN; RUTIN; SYMPLOCARPUS FOETIDUS ROOT; VIBURNUM OPULUS BARK 6; 5; 3; 6; 6; 6; 9; 6; 6; 12; 6; 12; 6; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0135_437b03e8-d7b6-4a27-9f12-890903fa5464 43742-0135 HUMAN OTC DRUG Bronchial Cough Coccus Cacti, Drosera, Scilla Maritima, Arsenicum Iodatum, Causticum, Cuprum Aceticum, Carbo Vegetabilis LIQUID ORAL 20120831 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACTIVATED CHARCOAL; ARSENIC TRIIODIDE; CAUSTICUM; CUPRIC ACETATE; DRIMIA MARITIMA BULB; DROSERA ROTUNDIFOLIA; LACHESIS MUTA VENOM; POTASSIUM CARBONATE; PROTORTONIA CACTI 12; 6; 6; 6; 4; 4; 12; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0136_0c22c637-83f6-45f7-966c-0837924cff59 43742-0136 HUMAN OTC DRUG Ileocecal Valve Support Iodium, Pituitary (Suis), Thyroidinum (Suis), Glandula Suprarenalis Suis, Fel Tauri, Taraxacum Officinale, Bryonia LIQUID ORAL 20120905 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACTIVATED CHARCOAL; BOS TAURUS BILE; BRYONIA ALBA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; INDOLE; IODINE; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; TARAXACUM OFFICINALE 30; 12; 30; 30; 30; 6; 30; 30; 30; 30; 30; 10; 8; 8; 12 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0137_c0346afd-0fff-4af0-819d-fd5ea96da8be 43742-0137 HUMAN OTC DRUG Inflammation Eupatorium Perfoliatum, Arnica Montana, Benzoicum Acidum, Echinacea, Mercurialis Perennis, Apis Mellifica, Baptisia Tinctoria LIQUID ORAL 20120905 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIS MELLIFERA; ARNICA MONTANA; BAPTISIA TINCTORIA; BENZOIC ACID; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; ECHINACEA, UNSPECIFIED; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; MERCURIALIS PERENNIS; SOLANUM DULCAMARA TOP; SOLANUM NIGRUM WHOLE; TOXICODENDRON PUBESCENS LEAF 4; 3; 4; 3; 4; 4; 3; 4; 2; 3; 4; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0153_6c23f58f-6b3e-4a66-add5-96011c9f24f7 43742-0153 HUMAN OTC DRUG Bacteria Cochlearia armoracia, Echinacea, Hydrastis canadensis, Lomatium dissectum, tabebuia impetiginosa, adrenalinum, Hepar suis, Lymph (suis), Spleen (suis), LIQUID ORAL 20120917 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc ARNICA MONTANA; ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GOLDENSEAL; HORSERADISH; HYPERICUM PERFORATUM; IRIDIUM; IRON; LOMATIUM DISSECTUM ROOT; NITRIC ACID; PHOSPHORIC ACID; PHOSPHORUS; PORK LIVER; SELENIUM; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; THYROID, PORCINE; ZINC 12; 12; 3; 8; 3; 3; 12; 12; 12; 3; 12; 12; 12; 8; 12; 12; 8; 8; 8; 3; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0154_00945f8f-6bbe-4eb1-9173-3d464c382ad6 43742-0154 HUMAN OTC DRUG Electrolyte Plus Boricum gluconicum, Calcarea gluconica, Chromium gluconicum, Cobaltum gluconicum, Ferrum fluconicum, Kali gluconicum, Magnesia gluconica, LIQUID ORAL 20121009 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BORON GLUCONATE; CALCIUM GLUCONATE; CHROMIUM GLUCONATE; COBALTOUS GLUCONATE; COPPER GLUCONATE; FERROUS GLUCONATE; MAGNESIUM GLUCONATE; MANGANESE GLUCONATE; NICKEL GLUCONATE; POTASSIUM GLUCONATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM DIOXIDE; SODIUM GLUCONATE; TRIBASIC CALCIUM PHOSPHATE; VANADIUM; ZINC GLUCONATE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 6; 6; 9; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0155_3a562a7f-a816-46dd-98a2-2cc306b70090 43742-0155 HUMAN OTC DRUG ELEVATE RxS LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SEPIA, BELLADONNA, CAUSTICUM, PHOSPHORUS, SULPHUR, 5-HYDROXYTRYPTOPHAN LIQUID ORAL 20120926 UNAPPROVED HOMEOPATHIC DESERET BIOLOGICALS, INC ACETYLCHOLINE CHLORIDE; ADENOSINE CYCLIC 3',5'-PHOSPHATE; ALCALIGENES FAECALIS; ALUMINUM OXIDE; ATROPA BELLADONNA WHOLE; CAUSTICUM; COENZYME A; DOPAMINE; LACTIC ACID, L-; LYCOPODIUM CLAVATUM SPORE; NOREPINEPHRINE; OXITRIPTAN; PHENETHYLAMINE; PHOSPHORUS; PROTEUS VULGARIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SEPIA OFFICINALIS JUICE; SEROTONIN; SILICON DIOXIDE; SODIUM CHLORIDE; SULFUR; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA UMBILICAL CORD 8; 10; 30; 8; 4; 4; 10; 8; 10; 3; 8; 6; 8; 4; 30; 30; 3; 8; 8; 3; 4; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0156_61f740b8-270d-4d8b-b4c9-f8e79d8c90eb 43742-0156 HUMAN OTC DRUG Gallic Acid Gallicum acidum, LIQUID ORAL 20120925 UNAPPROVED HOMEOPATHIC Deseret Biologicals GALLIC ACID 6 [hp_X]/mL 43742-0157_41f6c6ab-1571-41bc-bbfb-e99e3ff77b04 43742-0157 HUMAN OTC DRUG Joint Pain Arnica Montana, Bryonia, Causticum, Rhus Toxicodendron, Ferrum Phosphoricum LIQUID ORAL 20120920 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; FERROSOFERRIC PHOSPHATE; TOXICODENDRON PUBESCENS LEAF 4; 4; 4; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0158_82db5d28-9cf8-41c8-93a9-6fc971152482 43742-0158 HUMAN PRESCRIPTION DRUG Progesterone Progesterone LIQUID ORAL 20120920 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PROGESTERONE 6 [hp_X]/mL Progesterone [Chemical/Ingredient],Progesterone [EPC] 43742-0159_a61a6594-648f-4ccf-825a-3c47811ebec6 43742-0159 HUMAN OTC DRUG Vax Reaction Mezereum, Thuja Occidentalis, Silicea, Calcarea Carbonica, Morbillinum, Parotidinum, Pertussinum LIQUID ORAL 20120920 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ANTIMONY TRISULFIDE; CLOSTRIDIUM TETANI; DAPHNE MEZEREUM BARK; HUMAN BREAST TUMOR CELL; LEDUM PALUSTRE TWIG; MEASLES VIRUS; MUMPS VIRUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POLIOVIRUS; RUBELLA VIRUS; SILICON DIOXIDE; THIMEROSAL; THUJA OCCIDENTALIS LEAF 30; 30; 6; 15; 30; 30; 30; 30; 30; 30; 8; 30; 6 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 43742-0161_148a9a90-4229-42ac-9c01-87319d41788a 43742-0161 HUMAN PRESCRIPTION DRUG Hormone Combination Salsolinol hydrochloride, Cholesterinum, Dehydroepiandrsterone, Folliculinum, Oophorinum (suis), Progesterone, Testosterone, Cortisone aceticum, Aldosterone, Androsterone, Follicle stimulating hormone, LIQUID ORAL 20120924 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALDOSTERONE; ANDROSTERONE; CHOLESTEROL; CORTISONE ACETATE; ESTRONE; FOLLITROPIN; PRASTERONE; PROGESTERONE; SALSOLINOL HYDROCHLORIDE; SUS SCROFA OVARY; TESTOSTERONE 12; 12; 6; 12; 8; 12; 6; 8; 6; 8; 8 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Progesterone [Chemical/Ingredient],Progesterone [EPC],Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] 43742-0162_fa2253ab-36da-498a-8f85-fda242248fbf 43742-0162 HUMAN OTC DRUG Upper Respiratory Staph Step Combination Staphylococcus Aureus, Klebsiella Pneumoniae, Streptococcus Agalactiae, Streptococcus Alpha, Streptococcus Faecalis, Streptococcus Mutans, Streptococcus Pneumoniae LIQUID ORAL 20120910 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ENTEROCOCCUS FAECALIS; HAEMOPHILUS INFLUENZAE TYPE B; KLEBSIELLA PNEUMONIAE; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS MUTANS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS VIRIDANS GROUP 12; 12; 15; 15; 12; 12; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0163_769898ec-3aa0-493a-83dd-e33a0d6e40d7 43742-0163 HUMAN OTC DRUG Brucella Remedy Brucella Melitensis LIQUID ORAL 20120928 UNAPPROVED HOMEOPATHIC Deseret Biologicals BRUCELLA MELITENSIS 11 [hp_C]/mL 43742-0164_68231bac-684f-4d3d-9298-291a619c937c 43742-0164 HUMAN OTC DRUG Acetylcholine Chloride Acetylcholine Chloride LIQUID ORAL 20130911 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE 6 [hp_X]/mL 43742-0165_e9d499a4-b044-452b-9c78-2c43dc838a33 43742-0165 HUMAN PRESCRIPTION DRUG Addiclenz Beta Vulgaris, Boldo, Chelidonium Majus, Petroselinum Sativum, Taraxacum Officinale, Arsenicum Album, Belladonna LIQUID ORAL 20121113 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; ASPARTAME; ATROPA BELLADONNA WHOLE; BENZALKONIUM CHLORIDE; BETA VULGARIS; CHELIDONIUM MAJUS; COBALT; COPPER; FORMALDEHYDE; IODINE; LYCOPODIUM CLAVATUM SPORE; METHYLENE CHLORIDE; METHYLPARABEN; PETROSELINUM CRISPUM; PEUMUS BOLDUS LEAF; PHOSPHORIC ACID; PROPYLPARABEN; SELENIUM; SODIUM BENZOATE; SODIUM CITRATE; TARAXACUM OFFICINALE; TITANIUM DIOXIDE; ZINC; ZINC OXIDE 12; 30; 12; 30; 3; 3; 12; 12; 30; 12; 12; 30; 30; 3; 3; 12; 30; 12; 30; 30; 3; 30; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 43742-0166_8e34a13a-292c-4906-94bb-4e3a37a7a747 43742-0166 HUMAN OTC DRUG Kidney Drainage Solidago Virgaurea, Asparagus Officinalis, Juniperus Communis, Sabal Serrulata, Uva Ursi, Berberis Vulgaris, Equisetum Arvense LIQUID ORAL 20121113 20171217 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARCTOSTAPHYLOS UVA-URSI LEAF; ASPARAGUS; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; COBALT; DELPHINIUM STAPHISAGRIA SEED; EQUISETUM ARVENSE BRANCH; FAGUS SYLVATICA FLOWERING TOP; JUNIPER BERRY; LARIX DECIDUA FLOWERING TOP; LYTTA VESICATORIA; MANGANESE; MIMULUS GUTTATUS FLOWERING TOP; NITRIC ACID; PORK KIDNEY; RHUS AROMATICA ROOT BARK; RUBIA TINCTORUM ROOT; SAW PALMETTO; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; ULEX EUROPAEUS FLOWER; URTICA DIOICA 2; 2; 12; 3; 8; 8; 6; 3; 8; 2; 8; 6; 8; 8; 8; 8; 3; 6; 2; 8; 1; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0167_8b7e4852-0414-436c-bb02-b81cbb119fb8 43742-0167 HUMAN OTC DRUG Ver Artemisia vulgaris, Filix mas, Cina, Melilotus officinalis, Quassia amara, Spigelia anthelmia, Teucrium marum, Thymus serpyllum, Siliceea, Calcarea carbonica, LIQUID ORAL 20121114 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARTEMISIA CINA PRE-FLOWERING TOP; ARTEMISIA VULGARIS ROOT; ASCARIS LUMBRICOIDES; BRUGIA MALAYI; CRYPTOSPORIDIUM PARVUM; DRYOPTERIS FILIX-MAS ROOT; ENTEROBIUS VERMICULARIS; GIARDIA LAMBLIA; GRAPHITE; IODINE; MELILOTUS OFFICINALIS TOP; MERCURIC CHLORIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; QUASSIA AMARA WOOD; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA; TAENIA SAGINATA; TAENIA SOLIUM; TEUCRIUM MARUM; THYMUS SERPYLLUM; TRICHINELLA SPIRALIS; TRICHOMONAS VAGINALIS 3; 2; 15; 39; 20; 2; 33; 18; 12; 12; 3; 12; 12; 3; 12; 8; 3; 20; 12; 3; 3; 15; 13 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 43742-0168_7f839b1b-f539-4483-9f41-097aea80dad5 43742-0168 HUMAN OTC DRUG Dopamine Dopamine LIQUID ORAL 20121114 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. DOPAMINE 6 [hp_X]/mL 43742-0169_d6527e2b-a1a8-48c7-9654-0b65168c54a8 43742-0169 HUMAN OTC DRUG Governing Vessel Conception Vessel Phenylalanine, Taurine, Nerve(suis), Ascorbicum acidum, ATP, Brain(suis), Sarcolacticum acidum, Adrenocorticotrophin, Malvin, Apis mellifica, Arsenicum album, LIQUID ORAL 20121010 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc ADENOSINE TRIPHOSPHATE; APIS MELLIFERA; ARSENIC TRIOXIDE; ASCORBIC ACID; ATROPA BELLADONNA WHOLE; BARIUM CARBONATE; CICUTA VIROSA ROOT; CONIUM MACULATUM FLOWERING TOP; CORTICOTROPIN; IRON; LACHESIS MUTA VENOM; LACTIC ACID, L-; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; MALVIN; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHENYLALANINE; PHOSPHORUS; PORK BRAIN; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SHIGELLA DYSENTERIAE; SODIUM SULFATE; SUS SCROFA NERVE; TAURINE; THUJA OCCIDENTALIS LEAF 6; 30; 30; 6; 30; 30; 30; 30; 8; 30; 30; 6; 30; 30; 10; 30; 30; 6; 30; 6; 30; 30; 30; 30; 8; 6; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 43742-0170_eac2b8ba-6b3f-4bf7-99f5-5c25d38dcad4 43742-0170 HUMAN PRESCRIPTION DRUG Oratox Fucus Vesiculosus, Lymph Node, Medula Ossis Suis, Thymus, Thyroidinum, Calcarea Muriatica, Iodium LIQUID ORAL 20121031 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CALCIUM CHLORIDE; COPPER; EUGENOL; FORMALDEHYDE; FUCUS VESICULOSUS; GOLD; IODINE; LIDOCAINE; MERCURIUS SOLUBILIS; MOLYBDENUM; NICKEL; PALLADIUM; SELENIUM; SILVER; SODIUM CHLORIDE; SODIUM FLUORIDE; SUS SCROFA BONE MARROW; SUS SCROFA LYMPH; SUS SCROFA THYMUS; SUS SCROFA THYROID; TIN; TITANIUM; VANADIUM; ZINC 12; 12; 12; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 8; 8; 8; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 43742-0171_0ae4cfde-5dd3-4546-a305-b96e80dd85db 43742-0171 HUMAN OTC DRUG Skin Infections Ailanthus Glandulosus, Echinacea, Belladonna, Phytolacca Decandra, Hepar Sulphuris Calcareum, Mercurius Solubilis LIQUID ORAL 20121031 UNAPPROVED HOMEOPATHIC Deseret Biologials, Inc. AILANTHUS ALTISSIMA FLOWERING TWIG; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; CALCIUM SULFIDE; DAPHNE MEZEREUM BARK; ECHINACEA ANGUSTIFOLIA; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 3; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT 3; 12; 4; 8; 9; 3; 15; 15; 15; 12; 8; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0172_c093f409-11ad-453f-ab11-812a96ab5767 43742-0172 HUMAN OTC DRUG Trauma Remedy Chamomilla, Echinacea, Hamamelis Virginiana, Hypericum Perforatum, Millefolium, Bryonia, Calendula Officinalis LIQUID ORAL 20121031 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACHILLEA MILLEFOLIUM; ACTIVATED CHARCOAL; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS VITALBA FLOWER; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HELIANTHEMUM NUMMULARIUM FLOWER; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF 3; 12; 4; 6; 6; 4; 8; 4; 8; 3; 3; 8; 3; 8; 3; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0173_7a553ec8-4eef-49cf-8b7e-5c14a40c8096 43742-0173 HUMAN PRESCRIPTION DRUG Candida Albicans Remedy Candida Albicans LIQUID ORAL 20121031 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CANDIDA ALBICANS 15 [hp_X]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 43742-0174_87e1bb61-c865-4e3e-b2bf-58c4898f74bd 43742-0174 HUMAN PRESCRIPTION DRUG Herpes Zoster Remedy Herpes Zoster LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN HERPESVIRUS 3 15 [hp_X]/mL 43742-0175_4b19761a-f36a-4009-83e6-245a5e95c6d3 43742-0175 HUMAN OTC DRUG Gallbladder Liver Meridian Formula Cholesterinum, Histaminum Hydrochloricum, Menadione, Pyrrole, Alpha-Lipoicum Acidum, Ascorbicum Acidum, ATP, Fel Tauri LIQUID ORAL 20130911 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-LIPOIC ACID; ADENOSINE TRIPHOSPHATE; ARSENIC TRIOXIDE; ASCORBIC ACID; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; BOS TAURUS BILE; BRYONIA ALBA ROOT; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; LACTIC ACID, L-; LYCOPODIUM CLAVATUM SPORE; MENADIONE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PORK LIVER; POTASSIUM CARBONATE; PROTEUS MORGANII; PYRROLE; SEPIA OFFICINALIS JUICE; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA GALLBLADDER 6; 6; 30; 6; 30; 30; 6; 30; 6; 30; 30; 8; 6; 6; 30; 6; 30; 30; 6; 30; 30; 6; 30; 30; 30; 30; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0177_4ca66b41-d982-4a14-a689-39c593bb2496 43742-0177 HUMAN OTC DRUG GI Drainage Cinnamomum, Gentiana Lutea, Syzygium Jambolanum, Argentum Nitricum, Colchicum Autumnale, Colostrum, Copper Gluconate, LIQUID ORAL 20120928 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACTIVATED CHARCOAL; ARCTIUM LAPPA ROOT; BOS TAURUS COLOSTRUM; CINNAMON; COLCHICUM AUTUMNALE BULB; COPPER GLUCONATE; FAGUS SYLVATICA FLOWERING TOP; GENTIANA LUTEA ROOT; GOLD; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM GLUCONATE; MALUS SYLVESTRIS FLOWER; MANGANESE GLUCONATE; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK INTESTINE; POTASSIUM GLUCONATE; PRUNUS CERASIFERA FLOWER; RUMEX CRISPUS ROOT; SCROPHULARIA NODOSA; SILVER NITRATE; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; SYZYGIUM CUMINI SEED; WATER 8; 6; 6; 3; 6; 6; 8; 3; 8; 6; 6; 8; 6; 6; 8; 8; 6; 8; 6; 6; 6; 6; 6; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0178_76ea6403-860a-442b-8b64-ac046099486a 43742-0178 HUMAN OTC DRUG GABA GABA, LIQUID ORAL 20121107 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .GAMMA.-AMINOBUTYRIC ACID 6 [hp_X]/mL 43742-0179_8e616f16-0a19-43df-910a-5f983c5ae9b0 43742-0179 HUMAN OTC DRUG Sulphur Remedy Sulphur, Asclepias tuberosa, Bryonia, Dulcamara, LIQUID ORAL 20121012 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ASCLEPIAS TUBEROSA ROOT; BRYONIA ALBA ROOT; SOLANUM DULCAMARA STEM; SULFUR 6; 10; 10; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0180_1e35a2ee-6670-4fbd-b2a6-d6163a5a83d5 43742-0180 HUMAN OTC DRUG Stomach Spleen Meridian Opener Arsenicum Album, Calcarea Carbonica, Carduus Marianus, Ceanothus Americanus, Cinchona Officinalis, Digitalis Purpurea, Ignatia Amara LIQUID ORAL 20130911 UNAPPROVED HOMEOPATHIC Desert Biologicals, Inc. ARSENIC TRIOXIDE; CEANOTHUS AMERICANUS LEAF; CINCHONA OFFICINALIS BARK; DIGITALIS; LEAD; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; SILYBUM MARIANUM SEED; STRYCHNOS IGNATII SEED; VERATRUM VIRIDE ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0181_b4f45c4e-9f03-4f74-a827-a0b8e766f3b9 43742-0181 HUMAN OTC DRUG hA2cg Evolution Ascelpias vincetoxicum, Echinacea, Hypothalamus (suis) Brain (suis), Hepar (suis), Methylcobalamin, Pancreas suis, Renal (suis), Stomach (suis), LIQUID ORAL 20120816 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. 7-OXO-PRASTERONE; ADENOSINE TRIPHOSPHATE; APC-356433; APC-356434; CYNANCHUM VINCETOXICUM ROOT; ECHINACEA, UNSPECIFIED; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GLUCAGON; GRAPHITE; INSULIN PORK; LACTIC ACID, L-; METHYLCOBALAMIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; PORK BRAIN; PORK KIDNEY; PORK LIVER; PROTEUS VULGARIS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PANCREAS; SUS SCROFA STOMACH 30; 30; 8; 8; 6; 6; 12; 12; 30; 12; 30; 30; 8; 12; 12; 8; 8; 8; 30; 12; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0182_f1181605-5a24-4d73-a9d8-972ff5fbaee6 43742-0182 HUMAN OTC DRUG Herpes Simplex Remedy Herpes Simplex I, Herpes Simplex II LIQUID ORAL 20121012 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2 15; 15 [hp_X]/mL; [hp_X]/mL 43742-0184_36f1ed1d-ecdb-4127-9a2e-585f934758cf 43742-0184 HUMAN OTC DRUG Pre Dental Visit Juglans regia, Myosotis arvensis, Scrophularia nodosa, Teucrium scorodonia, Veronica officinalis, Equisetum arvense, Fumaria officinalis, Geranium robertianum, Nasturtium aquaticum, LIQUID ORAL 20121012 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARANEUS DIADEMATUS; CLEMATIS VITALBA FLOWER; EQUISETUM ARVENSE TOP; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; MYOSOTIS ARVENSIS; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PINUS SYLVESTRIS LEAFY TWIG; PRUNUS CERASIFERA FLOWER; SCROPHULARIA NODOSA; SMILAX REGELII ROOT; SODIUM SULFATE; SUS SCROFA LYMPH; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 12; 8; 4; 12; 4; 5; 4; 8; 8; 3; 8; 4; 8; 3; 6; 4; 12; 12; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0185_2d038e5d-aac4-46f9-8077-cd2945f9555e 43742-0185 HUMAN OTC DRUG Coniferyl Alcohol Coniferyl Alcohol LIQUID ORAL 20121029 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CONIFERYL ALCOHOL 6 [hp_X]/mL 43742-0186_16ff52d9-adee-4650-8799-52ed96991ff4 43742-0186 HUMAN OTC DRUG Epinephrine Adrenalinum, LIQUID ORAL 20121012 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. EPINEPHRINE 6 [hp_X]/mL 43742-0187_685fd627-a7ec-4a6c-8366-73ecf924b835 43742-0187 HUMAN OTC DRUG Trauma Relief Chamomilla, Echinacea, Hamamelis Virginiana, Hypericum Perforatum, Millefolium, Bryonia, Calendula Officinalis GEL TOPICAL 20121026 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACHILLEA MILLEFOLIUM; ACTIVATED CHARCOAL; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS VITALBA FLOWER; COMFREY ROOT; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HELIANTHEMUM NUMMULARIUM FLOWER; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF 3; 12; 4; 6; 6; 4; 8; 4; 6; 4; 3; 3; 6; 3; 6; 3; 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43742-0188_f3517fae-bf46-4151-a048-56b8bb5a7f32 43742-0188 HUMAN PRESCRIPTION DRUG Acetaldehyde Acetaldehyde LIQUID ORAL 20121107 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETALDEHYDE 6 [hp_X]/mL 43742-0189_f9a1be0a-594c-4cff-be3b-abde52cafc59 43742-0189 HUMAN PRESCRIPTION DRUG Eye Sarcode Eye LIQUID ORAL 20121029 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SUS SCROFA EYE 30 [hp_C]/mL 43742-0190_5aed1960-b95f-46a2-8a38-44cd657ea197 43742-0190 HUMAN PRESCRIPTION DRUG Female Support Chamomilla, Cimicifuga racemosa, Cinchona officinalis, Convallaria majalis, Crocus sativus, Helonias dioica, Hydrastis canadensis, Ledum palustre, Mentha piperita, Senna, LIQUID ORAL 20121114 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BLACK COHOSH; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; CINCHONA OFFICINALIS BARK; CINNAMON; CONVALLARIA MAJALIS; CYCLAMEN PURPURASCENS TUBER; DELPHINIUM STAPHISAGRIA SEED; GOLDENSEAL; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; LEDUM PALUSTRE TWIG; LILIUM LANCIFOLIUM WHOLE FLOWERING; MATRICARIA RECUTITA; MENTHA PIPERITA; NAJA NAJA VENOM; SAFFRON; SENNA LEAF; VALERIAN; VIOLA ODORATA 3; 3; 4; 3; 12; 3; 6; 4; 3; 12; 3; 4; 3; 3; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 43742-0191_ae366dcb-7ab5-4dc3-9c75-b2663a1b9b82 43742-0191 HUMAN PRESCRIPTION DRUG Malvin Malvin LIQUID ORAL 20121030 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MALVIN 15 [hp_C]/mL 43742-0192_522874a9-de3c-4a3e-b782-70c735ec4b25 43742-0192 HUMAN PRESCRIPTION DRUG Epstein-Barr Virus Remedy Epstein-Barr Virus LIQUID ORAL 20121029 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN HERPESVIRUS 4 15 [hp_X]/mL 43742-0193_e1bfe664-b637-430f-9d3d-e02e3642695d 43742-0193 HUMAN PRESCRIPTION DRUG Mycoplasma Remedy Mycoplasma Pneumoniae LIQUID ORAL 20121114 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MYCOPLASMA PNEUMONIAE 15 [hp_X]/mL 43742-0194_4c4ade95-75b5-4f21-b157-ec2043348759 43742-0194 HUMAN OTC DRUG Governing Vessel Conception Vessel Meridian Opener Apis Mellifica, Arsenicum Album, Baryta Carbonica, Belladonna, Calcarea Carbonica, Cicuta Virosa, Conium Maculatum LIQUID ORAL 20121227 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; BARIUM CARBONATE; CICUTA VIROSA ROOT; CONIUM MACULATUM FLOWERING TOP; IRON; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM SULFATE; THUJA OCCIDENTALIS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0195_6c31df05-2d57-43f8-aaf6-93739cd8f394 43742-0195 HUMAN OTC DRUG Male Stimulant Aralia Quinquefolia, Agnus Castus, Ascorbicum Acidum, Caladium Seguinum, Kali Bromatum, Strychninum Phosphoricum LIQUID ORAL 20121217 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMERICAN GINSENG; ASCORBIC ACID; CHASTE TREE; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; DIEFFENBACHIA SEGUINE; FERROSOFERRIC PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE PHOSPHATE, DIBASIC; PORK HEART; POTASSIUM BROMIDE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SELENIUM; STRYCHNINE PHOSPHATE DIHYDRATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; SUS SCROFA TESTICLE; SUS SCROFA UMBILICAL CORD; TESTOSTERONE; TURNERA DIFFUSA LEAFY TWIG; ZINC 4; 6; 6; 8; 13; 6; 10; 28; 8; 10; 8; 8; 6; 30; 10; 6; 8; 8; 12; 8; 8; 8; 8; 30; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0196_e2661d00-7404-4367-ae04-a4816dc443a2 43742-0196 HUMAN OTC DRUG HGH Vitality Agnus Castus, Ambra Grisea, Conium Maculatum, Apiolum, Estradiol, Estriol, Folliculinum, L Dopa, Melatonin, Testosterone LIQUID ORAL 20121226 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-LIPOIC ACID; ADENOSINE TRIPHOSPHATE; AMBERGRIS; APIOLE (PARSLEY); BARIUM CARBONATE; CHASTE TREE; COENZYME A; CONIUM MACULATUM FLOWERING TOP; ESTRADIOL; ESTRIOL; ESTRONE; LACTIC ACID, L-; LEVODOPA; MELATONIN; NADIDE; PORK LIVER; PROTEUS MORGANII; SELENIUM; SOMATROPIN; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA OVARY; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA TESTICLE; SUS SCROFA UMBILICAL CORD; TESTOSTERONE; UBIDECARENONE 8; 8; 6; 6; 8; 6; 8; 6; 6; 6; 6; 8; 6; 6; 8; 30; 30; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0197_dc9197a9-6ed8-4c12-a4ec-42e311d1d5b6 43742-0197 HUMAN PRESCRIPTION DRUG Adrenal Support 43742-0197 Aralia Quinquefolia, Humulus Lupulus, Adrenalinum, Cortisone Aceticum, Thyroidinum, Selenium Metallicum, Arsenicum Album LIQUID ORAL 20121114 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMERICAN GINSENG; ARSENIC TRIOXIDE; CONVALLARIA MAJALIS; CORTISONE ACETATE; CROTALUS HORRIDUS HORRIDUS VENOM; EPINEPHRINE; HOPS; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA THYROID 3; 12; 12; 6; 12; 6; 3; 12; 12; 30; 12; 8; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 43742-0198_c345850e-63f8-4612-8050-6615469d6a4b 43742-0198 HUMAN PRESCRIPTION DRUG Gallbladder Liver Meridian Opener Arsenicum Album, Berberis Vulgaris, Bryonia, Calcarea Carbonica, Carduus Marianus, Cinchona Officinalis, Kali Carbonicum LIQUID ORAL 20121115 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 43742-0199_99d2e1f8-7cf8-49ba-b412-83acce0be49c 43742-0199 HUMAN OTC DRUG Bladder Kidney Meridian Formula Cinnamic Acid, Phloridzinum, Alpha Ketoglutaricum Acidum, Ascorbicum Acidum, Kidney, Malic Acid, Nicotinamidum LIQUID ORAL 20121204 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-KETOGLUTARIC ACID; ALCALIGENES FAECALIS; APIS MELLIFERA; ASCORBIC ACID; BERBERIS VULGARIS ROOT BARK; CINNAMIC ACID; CORTICOTROPIN; EQUISETUM ARVENSE TOP; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MALIC ACID; MERCURIUS SOLUBILIS; NIACINAMIDE; PHLORIZIN; PHOSPHORUS; PORK KIDNEY; POTASSIUM DICHROMATE; PROTEUS VULGARIS; SEPIA OFFICINALIS JUICE; SHIGELLA DYSENTERIAE; SILVER NITRATE; SODIUM CHLORIDE; SUS SCROFA URINARY BLADDER; THUJA OCCIDENTALIS LEAF; TOXICODENDRON PUBESCENS LEAF; TURPENTINE OIL 6; 30; 30; 6; 30; 6; 8; 30; 30; 30; 6; 30; 6; 6; 30; 6; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0200_8765c730-f5d4-485f-b30a-2fbfd2c5d087 43742-0200 HUMAN OTC DRUG Lung Large Intestine Meridian Opener Aloe Socotrina, Alumina, Apis Mellifica, Arsenicum Album, Baryta Carbonica, Bryonia, Carbo Vegetabilis, Chamomilla LIQUID ORAL 20121115 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACTIVATED CHARCOAL; ALOE; ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; LEAD; MATRICARIA RECUTITA; PHOSPHORUS; POTASSIUM DICHROMATE; RANCID BEEF; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0201_b5f4a6e7-edfe-45cb-a7df-32fc042ca7c1 43742-0201 HUMAN PRESCRIPTION DRUG Tyramine Tyramine LIQUID ORAL 20121116 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TYRAMINE 6 [hp_X]/mL 43742-0202_78187182-1c19-4300-bde1-5300d178013d 43742-0202 HUMAN OTC DRUG Kidney Bladder Support Equisetum Hyemale, Solidago Virgaurea, Cantharis, Kidney (Suis), Belladonna, Berberis Vulgaris, Calcarea Carbonica, Terebinthina LIQUID ORAL 20130911 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIS MELLIFERA; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; DELPHINIUM STAPHISAGRIA SEED; EQUISETUM HYEMALE; LYTTA VESICATORIA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK KIDNEY; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SOLIDAGO VIRGAUREA FLOWERING TOP; TURPENTINE OIL 30; 12; 12; 30; 3; 6; 12; 8; 30; 30; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0203_2f689de5-2f0c-47be-9fa6-a99a9b33628a 43742-0203 HUMAN PRESCRIPTION DRUG Pertussis Aconitum Napellus, Antimonium Tartaricum, Belladonna, Bryonia, Hyoscyamus Niger, Ipecacuanha, Lobelia Inflata LIQUID ORAL 20121219 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA WHOLE; BRYONIA ALBA ROOT; CLOSTRIDIUM TETANI; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; HYOSCYAMUS NIGER; IPECAC; LOBARIA PULMONARIA; LOBELIA INFLATA; PHOSPHORUS; SILICON DIOXIDE; WOOD CREOSOTE 4; 4; 4; 4; 30; 30; 4; 4; 4; 4; 5; 8; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0204_5a4eb5b6-6f4e-4c6d-af90-262081b87eae 43742-0204 HUMAN OTC DRUG Petrochemical Detox Chelidonium Majus, Symphytum Officinale, Taraxacum Officinale, Trifolium Pratense, Acetone, Sodium Tripolyphosphate, Proylene glycol LIQUID ORAL 20130906 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETONE; AMMONIUM CHLORIDE; ARSENIC TRIOXIDE; CADMIUM SULFIDE; CHELIDONIUM MAJUS; COMFREY ROOT; GELSEMIUM SEMPERVIRENS ROOT; IRIDIUM; LATRODECTUS MACTANS; LIQUID PETROLEUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NITRIC ACID; PHOSPHORIC ACID; PLATINUM; PROPYLENE GLYCOL; SODIUM BENZENESULFONATE; SODIUM LAURYL SULFATE; SODIUM TRIPOLYPHOSPHATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; TURPENTINE OIL 9; 9; 12; 12; 3; 3; 12; 12; 15; 12; 12; 12; 12; 12; 12; 9; 9; 9; 9; 12; 3; 3; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0205_5330cd44-c443-42e7-b631-1aa666bf72b9 43742-0205 HUMAN OTC DRUG Melatonin Melatonin LIQUID ORAL 20121217 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MELATONIN 6 [hp_X]/mL 43742-0206_c72cfc73-18c8-499e-a32d-2772076ab102 43742-0206 HUMAN OTC DRUG Virus 2000 Cedron, Lathyrus Sativus, Plumbum Metallicum, Arnica Montana, Arsenicum Album, Conium Maculatum, Eupatorium Perfoliatum LIQUID ORAL 20130108 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARNICA MONTANA; ARSENIC TRIOXIDE; CONIUM MACULATUM FLOWERING TOP; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LATHYRUS SATIVAS SEED; LEAD; RANCID BEEF; SIMABA CEDRON SEED; TOXICODENDRON PUBESCENS LEAF; TURPENTINE OIL 30; 30; 30; 30; 30; 9; 12; 30; 8; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0207_fd7f1a49-c9a6-4ae7-9372-33d4dbfeea04 43742-0207 HUMAN OTC DRUG Bladder Kidney Meridian Opener Apis Mellifica, Argentum Nitricum, Berberis Vulgaris, Cantharis, Equisetum Arvense, Kali Bichromicum, Lycopodium Clavatum LIQUID ORAL 20121228 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; EQUISETUM ARVENSE TOP; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MERCURIUS SOLUBILIS; PHOSPHORUS; POTASSIUM DICHROMATE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAF; TOXICODENDRON PUBESCENS LEAF; TURPENTINE OIL 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0208_b310502e-701e-40b1-b845-2c9a4c04421f 43742-0208 HUMAN OTC DRUG Carcinosin Carcinosin LIQUID ORAL 20121008 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN BREAST TUMOR CELL 30 [hp_C]/mL 43742-0210_58c9cec3-5e44-4070-9b08-d3b6515121d9 43742-0210 HUMAN OTC DRUG Female Stimulant Core Formula Aquilegia Vulgaris, Hydrastis Canadensis, Lilium Tigrinum, Bovista, Cypripedium Pubescens, Apiolum LIQUID ORAL 20130412 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITIC ACID, (Z)-; ALCALIGENES FAECALIS; APIOLE (PARSLEY); APIS MELLIFERA VENOM; AQUILEGIA VULGARIS; CYPRIPEDIUM PARVIFOLUM ROOT; ESCHERICHIA COLI; ESTRADIOL; ESTRONE; GOLDENSEAL; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPERDON UTRIFORME FRUITING BODY; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS; PORK HEART; PROGESTERONE; SEPIA OFFICINALIS JUICE; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; SUS SCROFA UTERUS; TESTOSTERONE; WOOD CREOSOTE 10; 30; 6; 8; 4; 6; 30; 30; 8; 4; 10; 4; 6; 10; 10; 8; 30; 10; 8; 8; 12; 13; 6; 8; 8; 30; 8 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0211_7ae5e0a1-ee4e-4135-ad1a-c94c0fb80c22 43742-0211 HUMAN OTC DRUG Rutin Rutin LIQUID ORAL 20120227 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. RUTIN 6 [hp_X]/mL 43742-0212_81ab8527-24fa-4cc4-bd28-45b6fe7fbc99 43742-0212 HUMAN OTC DRUG Indole Indolum LIQUID ORAL 20130403 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. INDOLE 6 [hp_X]/mL 43742-0213_832ca3c0-e57f-4aec-bb64-c7390874871f 43742-0213 HUMAN OTC DRUG Mineral Balancing and Energy Viscum Album, Cobaltum Gluconicum, Cuprum Sulphuricum, Ferrum Fumaricum, Kali Asparaginicum, Magnesia Asparaginicum LIQUID ORAL 20130405 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE CYCLIC PHOSPHATE; ALUMINUM; ALUMINUM OXIDE; ANTIMONY TRISULFIDE; ARSENIC ACID; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CEROUS OXALATE NONAHYDRATE; CESIUM CHLORIDE; CHOLECALCIFEROL; CHROMIUM; COBALT; COBALTOUS GLUCONATE; COPPER; CUPRIC SULFATE; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; FERROUS FUMARATE; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; IRIDIUM; IRON; LANTHANUM OXIDE; LEAD; LITHIUM CARBONATE; MAGNESIUM; MAGNESIUM ASPARAGINATE; MANGANESE; MANGANESE GLUCONATE; MERCURIC CHLORIDE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NICKEL ACETATE TETRAHYDRATE; NIOBIUM; OSMIUM; PALLADIUM; PHOSPHORUS; PLATINUM; POTASSIUM ASPARAGINATE; PRASEODYMIUM; PROTEUS MORGANII; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; SILVER; SODIUM MOLYBDATE; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; TIN; URANYL NITRATE HEXAHYDRATE; VANADIUM; VISCUM ALBUM FRUITING TOP; YTTERBIUM OXIDE; ZINC 8; 12; 30; 12; 12; 12; 12; 12; 12; 12; 12; 12; 8; 12; 8; 12; 12; 6; 12; 6; 12; 12; 12; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 6; 12; 6; 30; 12; 12; 12; 12; 8; 12; 12; 12; 6; 12; 6; 12; 30; 12; 12; 12; 12; 12; 6; 12; 12; 12; 12; 12; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0214_126aaf17-df46-4865-b679-0cc108bbbce4 43742-0214 HUMAN OTC DRUG Healing Support Betula Pendula, Cortex, Caltha Palustris, Galium Aparine, Sedum Acre, Thuja Occidentalis, Urtica Urens, Clematis Erecta LIQUID ORAL 20130422 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIS MELLIFERA; BETULA PENDULA BARK; CALCIUM FLUORIDE; CALTHA PALUSTRIS; CLEMATIS RECTA FLOWERING TOP; ECHINACEA, UNSPECIFIED; GALIUM APARINE; HEDERA HELIX FLOWERING TWIG; JUNIPERUS COMMUNIS WHOLE; NITRIC ACID; ONONIS REPENS WHOLE; PHOSPHORUS; QUILLAJA SAPONARIA WOOD; RANCID BEEF; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; SILVER; THUJA OCCIDENTALIS LEAF; URTICA URENS 12; 2; 8; 3; 4; 5; 3; 4; 4; 6; 4; 8; 4; 12; 3; 4; 8; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0215_b0121729-d214-4bdb-94ae-a53f72bfbe36 43742-0215 HUMAN OTC DRUG Aspartame MSG Detox Chelidonium Majus, Phytolacca Decandra, Arnica Montana, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum LIQUID ORAL 20130422 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. 2,5-PIPERAZINEDIONE; ARNICA MONTANA; ASPARTIC ACID; CHELIDONIUM MAJUS; DOPAMINE; FORMALDEHYDE; FORMIC ACID; METHYL ALCOHOL; MONOSODIUM GLUTAMATE; NITRIC ACID; PHENYLALANINE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; STRYCHNOS NUX-VOMICA SEED 30; 6; 30; 3; 30; 30; 30; 30; 30; 12; 30; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0216_734ad610-4af1-4355-ba0b-9f97613bc158 43742-0216 HUMAN OTC DRUG Sore Throat Juglans Regia, Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale LIQUID ORAL 20130416 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARANEUS DIADEMATUS; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; PINUS SYLVESTRIS LEAFY TWIG; SARSAPARILLA; SCROPHULARIA NODOSA; SODIUM SULFATE; SUS SCROFA LYMPH; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 6; 4; 12; 4; 5; 4; 3; 3; 3; 4; 4; 6; 3; 4; 12; 12; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0217_0ec28830-4d57-425a-9b80-036e34011cff 43742-0217 HUMAN OTC DRUG Quercetin Quercetin LIQUID ORAL 20130411 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. QUERCETIN 6 [hp_X]/mL 43742-0218_b1c48fcb-f396-4052-bdd8-d1a1c452e973 43742-0218 HUMAN OTC DRUG Apiol Apiolum LIQUID ORAL 20130409 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIOLE (PARSLEY) 6 [hp_X]/mL 43742-0219_2eda26a8-e72e-489e-acee-a1366ca9b65d 43742-0219 HUMAN OTC DRUG Caffeic Acid Caffeic Acid LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CAFFEIC ACID 6 [hp_X]/mL 43742-0220_93835167-1786-472b-8e69-ff376b34079a 43742-0220 HUMAN OTC DRUG Lung Large Intestine Meridian Formula Coumarinum, Phenyl Isothicyanate, Intestine, Ascorbic Acid, Coenzyme A, Coenzyme Q 10, Colon, Lung LIQUID ORAL 20130416 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACTIVATED CHARCOAL; ALOE; ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; ASCORBIC ACID; BARIUM CARBONATE; BRYONIA ALBA ROOT; COENZYME A; COUMARIN; LACTIC ACID, L-; LEAD; MATRICARIA RECUTITA; PHENYL ISOTHIOCYANATE; PHOSPHORUS; PORK INTESTINE; POTASSIUM DICHROMATE; RANCID BEEF; RIBOFLAVIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE; SULFUR; SUS SCROFA COLON; SUS SCROFA LUNG; UBIDECARENONE 30; 30; 30; 30; 30; 6; 30; 30; 6; 6; 6; 30; 30; 6; 30; 8; 30; 30; 6; 30; 30; 30; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0221_bdf8d086-ae62-419e-b383-998606e6db7b 43742-0221 HUMAN OTC DRUG Pyrrole Pyrrole LIQUID ORAL 20130412 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PYRROLE 6 [hp_X]/mL 43742-0222_89081f82-87d2-4a48-8a7d-471edce6c79e 43742-0222 HUMAN OTC DRUG Phenyl Isothiocyanate Phenyl Isothiocyanate LIQUID ORAL 20130412 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PHENYL ISOTHIOCYANATE 6 [hp_X]/mL 43742-0223_2dd19b3e-a3e0-47b5-9ed7-41af06c85ec0 43742-0223 HUMAN OTC DRUG Detox III Conium Maculatum, Dulcamara, Echinacea, Aesculus Hippocastanum, Antimonium Tartaricum, Ascorbic Acid LIQUID ORAL 20130531 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; BARIUM CARBONATE; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; ECHINACEA ANGUSTIFOLIA; ESCHERICHIA COLI; FERROSOFERRIC PHOSPHATE; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; HORSE CHESTNUT; LACTIC ACID, L-; LIOTHYRONINE; MERCURIUS SOLUBILIS; PHENYLALANINE; PORK LIVER; PROTORTONIA CACTI; PULSATILLA VULGARIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA TONSIL; SUS SCROFA UMBILICAL CORD; TRIBASIC CALCIUM PHOSPHATE 6; 6; 28; 4; 13; 4; 30; 10; 6; 6; 6; 6; 6; 10; 13; 8; 10; 6; 6; 9; 4; 8; 8; 12; 10; 8; 10; 6; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43742-0224_19f366cb-2db4-495a-b3af-a32061b403cc 43742-0224 HUMAN OTC DRUG Chlorogenic Acid Chlorogenic Acid LIQUID ORAL 20130418 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHLOROGENIC ACID 30 [hp_X]/mL 43742-0225_597d2091-65a6-4b4d-aaed-365d49fc42a5 43742-0225 HUMAN OTC DRUG Reflux RxS Acetyl Coenzyme A, ATP, Nadidum, Coumarinum, Argentum Nitricum, Ipecacuanha, Robinia Pseudoacacia, Sulphur LIQUID ORAL 20130424 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE; ANHYDROUS CITRIC ACID; CENTAURIUM ERYTHRAEA; COENZYME A; COUMARIN; FORMIC ACID; HYDROCHLORIC ACID; IPECAC; LACTIC ACID, L-; NADIDE; OREGANO LEAF OIL; PEPSIN; PROTEUS MORGANII; ROBINIA PSEUDOACACIA BARK; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; SULFUR; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA STOMACH; SUS SCROFA UMBILICAL CORD 6; 6; 10; 6; 6; 6; 6; 6; 6; 6; 6; 12; 30; 6; 6; 6; 6; 8; 8; 8; 8 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0232_e8ef82b3-ac9f-4bb3-9ca4-3e95d0d20a70 43742-0232 HUMAN OTC DRUG Aspartame MSG Detox Chelidonium Majus, Phytolacca Decandra, Arnica Montana, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum LIQUID ORAL 20130612 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. 2,5-PIPERAZINEDIONE; ARNICA MONTANA; ASPARTIC ACID; BISPHENOL A; CHELIDONIUM MAJUS; DEXTROSE; DOPAMINE; FORMALDEHYDE; FORMIC ACID; MALTODEXTRIN; METHYL ALCOHOL; MONOSODIUM GLUTAMATE; NITRIC ACID; PHENYLALANINE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; STRYCHNOS NUX-VOMICA SEED; SUCRALOSE 30; 6; 30; 12; 3; 12; 30; 30; 30; 12; 30; 30; 12; 30; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0233_fa92bff4-665b-4050-b626-19a104aae63c 43742-0233 HUMAN OTC DRUG Mucous Membrane Core Formula Ceanothus Americanus, Hydrastis Canadensis, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango LIQUID ORAL 20130503 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ATROPA BELLADONNA WHOLE; CEANOTHUS AMERICANUS LEAF; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; MARSDENIA CONDURANGO BARK; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS MONTANA LEAF; PHOSPHORUS; PORK INTESTINE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SHIGELLA DYSENTERIAE; SILVER NITRATE; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; SUS SCROFA JEJUNUM; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; SUS SCROFA RECTUM; SUS SCROFA STOMACH; SUS SCROFA URINARY BLADDER; VERATRUM ALBUM ROOT; WOOD CREOSOTE; YEAST MANNAN 10; 4; 4; 8; 10; 10; 6; 6; 6; 8; 8; 8; 6; 6; 30; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 6; 4; 10; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0234_2ab9703e-caa0-488f-a023-c5d8bad0cea7 43742-0234 HUMAN OTC DRUG Cytomegalovirus Remedy Cytomegalovirus LIQUID ORAL 20130605 UNAPPROVED HOMEOPATHIC Deseret Biologicals HUMAN HERPESVIRUS 5 18 [hp_X]/mL 43742-0236_6a38eea2-5305-4a64-9dcb-70d0352cb3aa 43742-0236 HUMAN OTC DRUG Lymph Drainage Citrus Limonum, Echinacea, Scrophularia Nodosa, Teucrium Scorodonia, Baptisia Tinctoria, Lobelia Inflata, Phytolacca Decandra LIQUID ORAL 20130515 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARANEUS DIADEMATUS; ARSENIC TRIIODIDE; BAPTISIA TINCTORIA ROOT; CAPSICUM; CARPINUS BETULUS FLOWER; CENTAURIUM ERYTHRAEA FLOWER; COPPER GLUCONATE; ECHINACEA ANGUSTIFOLIA; LACHESIS MUTA VENOM; LARIX DECIDUA FLOWERING TOP; LEMON JUICE; LOBELIA INFLATA; MANGANESE GLUCONATE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; SCROPHULARIA NODOSA; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAF; ZINC GLUCONATE 8; 8; 1; 6; 8; 8; 6; 1; 12; 8; 1; 3; 6; 3; 3; 1; 8; 8; 8; 1; 4; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0237_f72c3f91-a9bb-4c28-bf7c-58babafe8fa4 43742-0237 HUMAN OTC DRUG Streptococcus Remedy Streptococcus Faecalis, Streptococcus Haemolyticus, Streptococcus Pneumoniae, Streptococcus Viridans LIQUID ORAL 20130614 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ENTEROCOCCUS FAECALIS; STREPTOCOCCUS MUTANS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PYOGENES; STREPTOCOCCUS VIRIDANS GROUP 15; 15; 15; 15; 15 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 43742-0238_a39b8d1e-7e7a-4690-974d-9ac343d2a8bb 43742-0238 HUMAN OTC DRUG Influenza Remedy Eucalyptus Globulus, Ipecacuanha, Aconitum Napellus LIQUID ORAL 20131016 UNAPPROVED HOMEOPATHIC Deseret Biologicals ACONITUM NAPELLUS; EUCALYPTUS GLOBULUS LEAF; IPECAC 3; 2; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0239_3919514a-aadc-4dc6-ad5a-3b2bcb1e8660 43742-0239 HUMAN OTC DRUG GRAIN MIX Coumarinum, Quercetin, Rutin, Bamboo, Barley, Corn, Cotton seed, Flax seed, Millet, Milo, Oat, Poppy seed, Rice, Rye, Safflower, Sesame, Sorghum, Sugar cane, LIQUID ORAL 20130801 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMARANTH; AVENA SATIVA FLOWERING TOP; BAMBUSA VULGARIS LEAF; BARLEY; BROWN RICE; CORN; CORTICOTROPIN; COTTON SEED; COUMARIN; ELYMUS REPENS ROOT; ENTEROCOCCUS FAECALIS; FLAX SEED; LACTIC ACID, L-; MILLET; OAT; POPPY SEED; QUERCETIN; RUTIN; RYE; SAFFLOWER; SESAME SEED; SODIUM SULFATE; SORGHUM; SORGHUM BICOLOR WHOLE; SOYBEAN; SUGARCANE; SUNFLOWER SEED; WHEAT 6; 6; 9; 9; 9; 9; 8; 9; 6; 6; 30; 9; 6; 9; 9; 9; 6; 6; 9; 9; 9; 6; 9; 9; 9; 9; 9; 9 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0240_413dc156-30d3-4b80-8371-707f36edbdc4 43742-0240 HUMAN OTC DRUG Radiation Chondrus crispus, Fucus vesiculosus, Thyroidinum (suis), Cadmium iodatum, Iodium, Strontium carbonicum, X-Ray, LIQUID ORAL 20121213 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALCOHOL, X-RAY EXPOSED (1000 RAD); CADMIUM IODIDE; CHONDRUS CRISPUS; FUCUS VESICULOSUS; IODINE; RADIUM BROMIDE; STRONTIUM CARBONATE; THYROID, PORCINE 30; 12; 3; 3; 12; 33; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0241_e92744ab-df6d-472b-aa64-dd33ce82e229 43742-0241 HUMAN OTC DRUG YEAST MIX Acetaldehyde, Coumarinum, Histaminum Hydrochloricum, Quercetin, Torula Cerevisiae, Candida Albicans, Candida Parapsilosis LIQUID ORAL 20130730 UNAPPROVED HOMEOPATHIC Deseret Biologicals ACETALDEHYDE; ALCALIGENES FAECALIS; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; CORTICOTROPIN; COUMARIN; HISTAMINE DIHYDROCHLORIDE; LACTIC ACID, L-; QUERCETIN; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE 6; 30; 12; 12; 6; 6; 6; 6; 6; 10; 6 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 43742-0242_cc7cfaca-4fe1-4dea-86e0-ea20d6236b1d 43742-0242 HUMAN OTC DRUG Celeragesic Echinacea, Echinacea Purpurea, Bellis Perennis, Calendula Officinalis, Hamamelis Virginiana, Acontium Napellus, Chamomilla, Hypericum Perforatum GEL TOPICAL 20130812 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ACTIVATED CHARCOAL; ADENOSINE TRIPHOSPHATE; ARNICA MONTANA; ATROPA BELLADONNA WHOLE; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS VITALBA FLOWER; COENZYME A; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HELIANTHEMUM NUMMULARIUM FLOWER; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; LACTIC ACID, L-; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; NADIDE; ORNITHOGALUM UMBELLATUM; PROTEUS MORGANII; PRUNUS CERASIFERA FLOWER; SUS SCROFA ADRENAL GLAND; SUS SCROFA THALAMUS; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF; UBIDECARENONE 3; 3; 12; 8; 4; 3; 2; 4; 8; 2; 8; 8; 8; 2; 2; 2; 8; 3; 8; 8; 3; 8; 8; 8; 30; 8; 12; 12; 12; 6; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43742-0243_6e9bfd13-6a1b-4668-ba41-06b1c6d3c333 43742-0243 HUMAN OTC DRUG KIDNEY DRAINAGE SOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS LIQUID ORAL 20130805 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARCTOSTAPHYLOS UVA-URSI LEAF; ASPARAGUS; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; COBALT; DELPHINIUM STAPHISAGRIA SEED; EQUISETUM ARVENSE TOP; FAGUS SYLVATICA FLOWERING TOP; JUNIPERUS COMMUNIS WHOLE; LARIX DECIDUA FLOWERING TOP; LYTTA VESICATORIA; MANGANESE; MIMULUS GUTTATUS FLOWERING TOP; NITRIC ACID; PORK KIDNEY; RHUS AROMATICA ROOT BARK; RUBIA TINCTORUM ROOT; SAW PALMETTO; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; ULEX EUROPAEUS FLOWER; URTICA DIOICA 2; 2; 12; 3; 8; 8; 6; 3; 8; 2; 8; 6; 8; 8; 8; 8; 3; 6; 2; 8; 1; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0244_e45e3104-90ab-48f6-97c4-39ae0031807b 43742-0244 HUMAN OTC DRUG PERICARDIUM TRIPLE WARMER MERIDIAN OPENER Arsenic Album, Aurum Metallicum, Baryta Carbonica, Calcarea Carbonica, Glonoinum, Iodium, Kali Iodatum Lachesis Mutus, Lithium Carbonicum LIQUID ORAL 20130807 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; BARIUM CARBONATE; GOLD; IODINE; LACHESIS MUTA VENOM; LITHIUM CARBONATE; LOBELIA INFLATA; MERCURIUS SOLUBILIS; NAJA NAJA VENOM; NITROGLYCERIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM IODIDE; SEPIA OFFICINALIS JUICE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0245_b995d92d-de7d-4a5b-bfb5-e5fb1e97afb5 43742-0245 HUMAN PRESCRIPTION DRUG PIPERINE Piperine LIQUID ORAL 20130809 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PIPERINE 6 [hp_X]/mL 43742-0246_87386f75-1230-4017-b702-4e31f8632b07 43742-0246 HUMAN OTC DRUG Borrelia Babesia Remedy Babesia Microti, Borrelia Burgdorferi LIQUID ORAL 20130820 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BABESIA MICROTI; BORRELIA BURGDORFERI 15; 15 [hp_X]/mL; [hp_X]/mL 43742-0247_96f07660-3b4c-460d-b39c-5a46b3b4aa3c 43742-0247 HUMAN OTC DRUG Chronagesic Arnica Montana, Rhus Toxicodendron, Dulcamara, Sanguinaria Canadensis, Cartilago Suis, Coenzyme A, Funiculus Umbilicalis Suis LIQUID ORAL 20130813 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-LIPOIC ACID; APIOLE (PARSLEY); ARNICA MONTANA; CHONDROITIN SULFATE SODIUM (BOVINE); CINNAMIC ACID; COENZYME A; COMFREY ROOT; DIMETHYL SULFONE; ENTEROCOCCUS FAECALIS; MENADIONE; NADIDE; PIPERINE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SOLANUM DULCAMARA TOP; SOMATROPIN; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF 8; 6; 1; 6; 6; 6; 8; 6; 30; 6; 6; 6; 30; 3; 8; 6; 2; 30; 6; 6; 6; 6; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0248_6aa475e5-167e-4e1c-b1f2-a3224eb2ce84 43742-0248 HUMAN PRESCRIPTION DRUG Gyno Complex Viburnum Opulus, Magnesia Phosphorica, Folliculnum, Pulsatilla, Borax, Mercurius Solubilis, Nitricum Acidum, Silicea, Thuja Occidentalis LIQUID ORAL 20130820 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc ESTRONE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS; NITRIC ACID; PULSATILLA VULGARIS; SILICON DIOXIDE; SODIUM BORATE; THUJA OCCIDENTALIS LEAF; VIBURNUM OPULUS BARK 12; 8; 30; 30; 12; 30; 30; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 43742-0249_98b81182-393a-424b-a270-535143698ca6 43742-0249 HUMAN OTC DRUG Free Radical Alfalfa, Ascorbyl Palmitate, Cysteinum, Hordeum Vulgare, Laminaria Digitata, Manganese Gluconate, methionine, Nasturtium Aquaticum LIQUID ORAL 20130822 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; .ALPHA.-TOCOPHEROL; ALFALFA; ASCORBYL PALMITATE; BROWN RICE; COBALT; CYSTEINE; GLUTATHIONE; GLYOXAL; HORDEUM VULGARE TOP; IRON; LAMINARIA DIGITATA; MAGNESIUM FLUORIDE; MANGANESE GLUCONATE; METHIONINE; N,N-DIMETHYLGLYCINE; NASTURTIUM OFFICINALE; QUERCETIN; RAPHANUS SATIVUS; SELENIUM; SODIUM SELENITE; TRITICUM AESTIVUM WHOLE; UBIDECARENONE; ZINC; ZINC PICOLINATE 30; 8; 8; 6; 6; 8; 12; 6; 12; 30; 6; 12; 6; 12; 6; 6; 6; 6; 6; 6; 12; 6; 6; 6; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0250_92a7f297-5fd2-4754-941b-2654dea0f14a 43742-0250 HUMAN PRESCRIPTION DRUG Sugar Mix Cinnamic Acid, Phloridzinum, ATP, Argentum Nitricum, Beet Sugar, D-Ribose, Fructose, Dextrose, Grape Sugar (Syrup), Lycopodium Clavatum, LIQUID ORAL 20130822 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACER SACCHARUM SAP; ADENOSINE TRIPHOSPHATE; CINNAMIC ACID; CORTICOTROPIN; DEXTROSE; FRUCTOSE; LACTIC ACID, L-; LACTOSE; LYCOPODIUM CLAVATUM SPORE; MALVIN; PHLORIZIN; PROTEUS MORGANII; RIBOSE, D-; SHIGELLA DYSENTERIAE; SILVER NITRATE; SUCROSE 6; 6; 6; 8; 6; 6; 6; 6; 6; 15; 6; 30; 6; 30; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] 43742-0251_a7bc83d5-660b-40e7-a4e5-cd811ec8701e 43742-0251 HUMAN OTC DRUG Intestinal Distress Echinacea, Colchicum Autumnale, Aloe Socotrina, Colocynthis, Mercurius Corrosivus, Nux Vomica, Arsenicum Album, Chininum Sulphuricum LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALOE; ARSENIC TRIOXIDE; BOTULINUM TOXIN TYPE A; CAMPYLOBACTER JEJUNI; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; ECHINACEA, UNSPECIFIED; ESCHERICHIA COLI; HELICOBACTER PYLORI; MERCURIC CHLORIDE; QUININE SULFATE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SHIGELLA DYSENTERIAE; STRYCHNOS NUX-VOMICA SEED; VIBRIO CHOLERAE; YERSINIA ENTEROCOLITICA 6; 6; 30; 30; 6; 4; 3; 30; 30; 6; 12; 33; 30; 6; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0252_512d9f98-6ee5-4695-8648-68ab4d58cea2 43742-0252 HUMAN OTC DRUG Glucagon Glucagon LIQUID ORAL 20130822 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GLUCAGON 8 [hp_X]/mL 43742-0253_b9abd521-d89c-4c64-ab2d-aab52eef3a03 43742-0253 HUMAN OTC DRUG Vascuflow RXS Cholesterinum, Formalinum, Gelsemium Sempervirens, Melatonin, Arginine, Citrulline, Coumarinum, Coenzyme Q10, Mercurius Corrosivus LIQUID ORAL 20130916 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-LIPOIC ACID; ARGININE; BERBERIS VULGARIS ROOT BARK; CHOLESTEROL; CITRULLINE; COENZYME A; COUMARIN; FORMALDEHYDE; GELSEMIUM SEMPERVIRENS ROOT; LANOSTEROL; LEAD; LYCOPODIUM CLAVATUM SPORE; MELATONIN; MERCURIC CHLORIDE; MEVALONOLACTONE, (+/-)-; NITRIC OXIDE; NITROGLYCERIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PROTEUS MORGANII; RED YEAST; SQUALENE; TOXICODENDRON PUBESCENS LEAF; UBIDECARENONE 8; 6; 8; 3; 6; 10; 6; 3; 6; 8; 8; 6; 6; 6; 8; 12; 6; 8; 6; 30; 8; 8; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 43742-0256_6be5651c-55cf-4a62-8835-6d59654d7201 43742-0256 HUMAN OTC DRUG Hormone Mix System Formula Dehydroepindrosterone, Estrogen, Progesterone, Testosterone, Placenta Totalis (Suis), Glandula Suprarenalis Suis, Oophorinum (Suis) LIQUID ORAL 20130918 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALCALIGENES FAECALIS; ESTRADIOL; ESTRIOL; ESTRONE; PRASTERONE; PROGESTERONE; SEPIA OFFICINALIS JUICE; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; TESTOSTERONE 30; 30; 30; 30; 30; 30; 6; 6; 6; 6; 6; 30 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43742-0257_c2ff6654-2929-49cb-ac8a-65efb311fdae 43742-0257 HUMAN OTC DRUG Male Stimulant Aralia Quinquefolia, Agnus Castus, Ascorbic Acid, Caladium Seguinum, Kali Bromatum, Strychninum Phosphoricum, Cantharis, Damiana, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Orchitinum, Pituitaria Glandula, LIQUID ORAL 20131021 UNAPPROVED HOMEOPATHIC Deseret Biologicals AMERICAN GINSENG; ASCORBIC ACID; CHASTE TREE; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; DIEFFENBACHIA SEGUINE; FERROSOFERRIC PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE PHOSPHATE, DIBASIC; PORK HEART; POTASSIUM BROMIDE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SELENIUM; STRYCHNINE PHOSPHATE DIHYDRATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; SUS SCROFA TESTICLE; SUS SCROFA UMBILICAL CORD; TESTOSTERONE; TURNERA DIFFUSA LEAFY TWIG; ZINC 4; 6; 6; 8; 13; 6; 10; 28; 8; 10; 20; 8; 6; 30; 10; 6; 8; 8; 12; 8; 8; 8; 8; 30; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0290_f530e9b7-6248-4043-b857-223518bef145 43742-0290 HUMAN OTC DRUG Neuro I Hydrastis Canadensis, Taraxacum Officinale, Dopamine, L-Dopa, Melatonin, Serotonin (Hydrochloride) LIQUID ORAL 20130904 UNAPPROVED HOMEOPATHIC Deseret Biologicals DOPAMINE; GOLDENSEAL; LEVODOPA; MELATONIN; SEROTONIN HYDROCHLORIDE; TARAXACUM OFFICINALE 6; 3; 6; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0291_6dc3b7b0-d7f5-4cbc-99ed-a7a59a1ce94d 43742-0291 HUMAN OTC DRUG Cerebromax Acetylcholine Chloride, Adrenalinum, Dopamine, Gaba, Norepinephrine, Octopamine, Serotonin (Hydrochloride), Taurine, Adenosinum Cyclophosphoricum LIQUID ORAL 20130904 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; ADENOSINE CYCLIC PHOSPHATE; DOPAMINE; EPINEPHRINE; NOREPINEPHRINE; OCTOPAMINE; SEROTONIN HYDROCHLORIDE; SUS SCROFA CEREBELLUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; TAURINE 6; 6; 8; 6; 6; 6; 6; 6; 8; 8; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0292_2ba6b9bd-c4a5-43fe-bf27-37142fe0363c 43742-0292 HUMAN OTC DRUG Enviro II Potassium Gluconate, Glandula Suprarenalis Suis, Hepar Suis, Canary Feathers, Standardized Cat Hair, Cattle Epithelia, Chicken Feathers LIQUID ORAL 20130923 UNAPPROVED HOMEOPATHIC Deseret Biologicals ACER NEGUNDO POLLEN; AGROSTIS GIGANTEA POLLEN; ALFALFA; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ARSENIC TRIOXIDE; BARLEY; BETULA OCCIDENTALIS POLLEN; BOS TAURUS SKIN; BROWN RICE; CANIS LUPUS FAMILIARIS SKIN; CAPRA HIRCUS SKIN; CARYA OVATA POLLEN; CAVIA PORCELLUS SKIN; CORN GRAIN; DACTYLIS GLOMERATA TOP; DERMATOPHAGOIDES FARINAE; EQUUS CABALLUS SKIN; FAGUS GRANDIFOLIA POLLEN; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; GALLUS GALLUS FEATHER; HISTAMINE DIHYDROCHLORIDE; HOUSE DUST; HYALURONIDASE; INTERFERON .GAMMA. PORCINE RECOMBINANT; IRIDIUM; JUGLANS NIGRA POLLEN; MELOPSITTACUS UNDULATUS FEATHER; MERIONES UNGUICULATUS SKIN; MESOCRICETUS AURATUS SKIN; MILLET; MUS MUSCULUS SKIN; OAT; ORYCTOLAGUS CUNICULUS SKIN; PHLEUM PRATENSE TOP; PHOSPHORUS; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS TOP; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; PORK LIVER; POTASSIUM GLUCONATE; QUERCUS RUBRA POLLEN; RATTUS NORVEGICUS SKIN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS TOP; SALIX NIGRA POLLEN; SELENIUM; SERINUS CANARIA FEATHER; SEROTONIN HYDROCHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SORGHUM BICOLOR WHOLE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA SKIN; TRIFOLIUM PRATENSE FLOWER; ULMUS AMERICANA POLLEN; WHEAT 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 30; 9; 30; 30; 12; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 9; 9; 9; 8; 6; 9; 9; 9; 9; 9; 12; 9; 30; 9; 9; 12; 8; 9; 9; 9; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0294_1ddf7e71-bbc2-459d-939a-fb7e0878cca1 43742-0294 HUMAN OTC DRUG Allergy Rescue Acetylcholine Chloride, Histaminum Hydrochloricum, Serotonin (Hydrochloride) LIQUID ORAL 20130930 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE; HISTAMINE DIHYDROCHLORIDE; SEROTONIN HYDROCHLORIDE 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0295_7724980e-01f6-488b-a831-82d57d8e5df1 43742-0295 HUMAN OTC DRUG Serotonin Serotonin (Hydrochloride) LIQUID ORAL 20130930 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SEROTONIN HYDROCHLORIDE 6 [hp_X]/mL 43742-0296_f1a7072e-874a-4f72-a042-dcb787f32a1a 43742-0296 HUMAN OTC DRUG Cinnamic Acid Cinnamic Acid LIQUID ORAL 20130930 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CINNAMIC ACID 6 [hp_X]/mL 43742-0298_c6788a6a-c87a-403e-9c21-643812be825e 43742-0298 HUMAN OTC DRUG Sore Throat Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale, Fumaria Officinalis LIQUID ORAL 20131004 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARANEUS DIADEMATUS; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MYOSOTIS ARVENSIS; NASTURTIUM AQUATICUM; PINUS SYLVESTRIS LEAFY TWIG; SARSAPARILLA; SCROPHULARIA NODOSA; SODIUM SULFATE; SUS SCROFA LYMPH; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 6; 4; 12; 4; 5; 4; 5; 5; 3; 4; 4; 6; 3; 4; 12; 12; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0299_bd43fa4d-55b0-4754-81eb-737f1e8ac475 43742-0299 HUMAN OTC DRUG Menadione Menadione LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC Deseret Biologicals MENADIONE 6 [hp_X]/mL 43742-0300_08a0226e-3576-4f04-b884-32a7592b8fb6 43742-0300 HUMAN OTC DRUG Enviro I Potassium Gluconate, Glandula Suprarenalis Suis, Hepar Suis, Bamboo, Barley, Corn, Levant Cotton, Flax, Millet, Milo, Oat, California Poppy, Rice, Rye, Safflower, LIQUID ORAL 20140103 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACTIVATED CHARCOAL; ALPINE STRAWBERRY; BAMBUSA VULGARIS LEAF; BANANA; BARLEY; BEEF; BITTER ALMOND; BLACK PEPPER; BLACK WALNUT; BRAZIL NUT; BROWN RICE; CASEIN, LACTOCOCCUS LACTIS CULTURED; CASHEW; CHICKEN; COCOA; COCONUT; COD, UNSPECIFIED; COFFEA ARABICA SEED, ROASTED; CORN; CORTISONE ACETATE; COW MILK; EGG; EGGPLANT; ENGLISH WALNUT; ESCHSCHOLZIA CALIFORNICA; FERROUS IODIDE; FLAX SEED; GELSEMIUM SEMPERVIRENS ROOT; GREEN TEA LEAF; HISTAMINE DIHYDROCHLORIDE; HYALURONIDASE; INTERFERON .GAMMA. PORCINE RECOMBINANT; IODINE; IRIDIUM; IRON; KIDNEY BEAN; LAMB; LEVANT COTTON SEED; LIMULUS POLYPHEMUS; LYCOPODIUM CLAVATUM SPORE; MALUS DOMESTICA FLOWER; MILLET; OAT; ONION; ORANGE; OYSTER, UNSPECIFIED; PEANUT; PECAN; PORK; PORK LIVER; POTASSIUM GLUCONATE; POTATO; PULSATILLA VULGARIS; RYE; SAFFLOWER; SALMON, UNSPECIFIED; SELENIUM; SEROTONIN HYDROCHLORIDE; SESAME SEED; SHRIMP, UNSPECIFIED; SORGHUM; SORGHUM BICOLOR WHOLE; SOYBEAN; SUGARCANE; SUNFLOWER SEED; SUS SCROFA ADRENAL GLAND; TOMATO; TUNA, UNSPECIFIED; WHEAT; ZINC 12; 12; 9; 12; 9; 12; 12; 12; 12; 12; 9; 12; 12; 12; 10; 12; 12; 10; 9; 30; 12; 12; 12; 12; 9; 12; 9; 12; 10; 30; 30; 30; 12; 12; 12; 12; 12; 9; 12; 12; 12; 9; 9; 12; 12; 12; 12; 12; 12; 8; 6; 12; 12; 9; 9; 12; 12; 30; 9; 12; 9; 9; 9; 9; 9; 8; 12; 12; 9; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0302_b30d6cc1-5c01-4957-8c49-c86360dcdccf 43742-0302 HUMAN OTC DRUG Brain Balance Core Formula Acetylcholine Chloride, Dopamine, Gaba, Octopamine, Serotonin, Taurine, Adenosinum Cyclophosphoricum, Cerebrum, Diencephalon, Pineal Gland, Thalamus Opticus LIQUID ORAL 20140103 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; ADENOSINE CYCLIC PHOSPHATE; DOPAMINE; OCTOPAMINE; SEROTONIN HYDROCHLORIDE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; TAURINE 6; 6; 8; 6; 6; 6; 8; 8; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0303_bc0dc7e6-e221-4b81-81e5-d9bf0622bf21 43742-0303 HUMAN PRESCRIPTION DRUG Salsolinol Salsolinol LIQUID ORAL 20140109 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SALSOLINOL 6 [hp_X]/mL 43742-0304_e1f03c93-7b9d-449d-bf24-7e3f0f576c74 43742-0304 HUMAN OTC DRUG Octopamine Octopamine LIQUID ORAL 20140110 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. OCTOPAMINE 6 [hp_X]/mL 43742-0305_770d0e24-330d-41b6-ac4e-8f7a4f129635 43742-0305 HUMAN OTC DRUG Bacteria Combination not applicable LIQUID ORAL 20140829 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE; APIOLE (PARSLEY); CINNAMIC ACID; ECHINACEA ANGUSTIFOLIA; ENTEROCOCCUS FAECALIS; ESCHERICHIA COLI; HELICOBACTER PYLORI; LEGIONELLA PNEUMOPHILA; LISTERIA MONOCYTOGENES; MALIC ACID; MYCOPLASMA PNEUMONIAE; OROTIC ACID MONOHYDRATE; PROTEUS MIRABILIS; PROTEUS MORGANII; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; RIBOFLAVIN; SHIGELLA DYSENTERIAE; SHIGELLA SONNEI; SODIUM DIETHYL OXALACETATE; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS EQUINUS; STREPTOCOCCUS MUTANS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PYOGENES; STREPTOCOCCUS UBERIS; STREPTOCOCCUS VIRIDANS GROUP; YERSINIA ENTEROCOLITICA 6; 6; 6; 15; 13; 15; 15; 11; 14; 6; 15; 6; 15; 30; 15; 15; 6; 15; 15; 6; 9; 15; 32; 13; 15; 15; 15; 12; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43742-0307_54173bc9-a8ed-453e-aecc-cbe49940d3c2 43742-0307 HUMAN OTC DRUG PHYTOLACCA 200C not applicable LIQUID ORAL 20140723 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PHYTOLACCA AMERICANA ROOT 200 [hp_C]/mL 43742-0308_4bfd039c-5eeb-4fb1-850f-ae7158cf2b86 43742-0308 HUMAN OTC DRUG Egg Mix System Formula Asparagine, Phenylalanine, Quercetin, Canary feathers, Standardized cat hair, Cattle epithelia, Chicken feathers, Dog epithelia, Duck feathers, Gerbil epithelia, LIQUID ORAL 20120620 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASCORBIC ACID; ASPARAGINE; BOS TAURUS SKIN; CANIS LUPUS FAMILIARIS SKIN; CAPRA HIRCUS SKIN; CAVIA PORCELLUS SKIN; EQUUS CABALLUS SKIN; FELIS CATUS HAIR; FERROUS IODIDE; GALLUS GALLUS FEATHER; MELOPSITTACUS UNDULATUS FEATHER; MERIONES UNGUICULATUS SKIN; MESOCRICETUS AURATUS SKIN; MUS MUSCULUS SKIN; ORYCTOLAGUS CUNICULUS SKIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHENYLALANINE; PROTEUS MORGANII; QUERCETIN; RATTUS NORVEGICUS SKIN; SERINUS CANARIA FEATHER; SUS SCROFA SKIN; TETRACYCLINE 9; 9; 6; 6; 9; 9; 9; 9; 9; 9; 6; 9; 9; 9; 9; 9; 9; 6; 6; 30; 6; 9; 9; 9; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 43742-0309_57344ac4-5a01-4af8-86cf-8327db1244a0 43742-0309 HUMAN OTC DRUG Basic Detox Core Formula not applicable LIQUID ORAL 20140828 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; AVENA SATIVA FLOWERING TOP; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; FORMIC ACID; GLYOXAL; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; MALIC ACID; MENADIONE; METHYLCOBALAMIN; MILK THISTLE; OROTIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK INTESTINE; PORK LIVER; PROTEUS MORGANII; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA GALLBLADDER; SUS SCROFA LYMPH; SUS SCROFA PANCREAS; SUS SCROFA THYMUS; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOT 8; 8; 6; 4; 10; 4; 6; 10; 10; 10; 4; 10; 6; 6; 3; 7; 28; 8; 8; 30; 30; 10; 13; 8; 8; 8; 8; 8; 8; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0321_ae97943c-622c-4ca3-8dda-12f077b7a284 43742-0321 HUMAN OTC DRUG Bartonella Remedy Bartonella bacilliformis, Bartonella clarridgeiae, Bartonella elizabethae, Bartonella henselae, Bartonella quintana, Bartonella vinsonii, Bartonella washoensis, LIQUID ORAL 20140425 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BARTONELLA BACILLIFORMIS; BARTONELLA CLARRIDGEIAE; BARTONELLA ELIZABETHAE; BARTONELLA HENSELAE; BARTONELLA QUINTANA; BARTONELLA VINSONII; BARTONELLA WASHOENSIS 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0322_480a121e-c2af-4140-b308-8b013a190095 43742-0322 HUMAN OTC DRUG Trauma Relief Gel Chamomilla, Echinacea, Hamamelis Virginiana, Hypericum Perforatum, Milleforlium, Byronia, Calendula Officinalis, Symphytum Officinale GEL TOPICAL 20130805 UNAPPROVED HOMEOPATHIC Deseret Biologicals ACTIVATED CHARCOAL; ARNICA MONTANA; ATROPA BELLADONNA WHOLE; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS VITALBA FLOWER; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HELIANTHEMUM NUMMULARIUM FLOWER; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF 12; 4; 6; 6; 4; 8; 4; 6; 4; 3; 3; 6; 3; 6; 3; 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43742-0323_8c8b4008-0a8d-4b66-8f03-2dd4a317f88e 43742-0323 HUMAN OTC DRUG Bug Bouncer Grindelia (Robusta), Urtica urens, Ledum palustre, Staphysagria, Cedron, LIQUID ORAL 20140612 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. DELPHINIUM STAPHISAGRIA SEED; GRINDELIA HIRSUTULA WHOLE; LEDUM PALUSTRE TWIG; SIMABA CEDRON SEED; URTICA URENS 4; 1; 4; 6; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 43742-0324_b24f6454-7cc2-4bb9-a168-98d3abc5fcf3 43742-0324 HUMAN OTC DRUG Bio Tonico not applicable LIQUID ORAL 20140902 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHAMAELIRIUM LUTEUM ROOT; GOLD; HYPERICUM PERFORATUM; POTASSIUM PHOSPHATE, DIBASIC; QUININE ARSENITE; SELENIUM; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0325_64feb339-c70a-44ae-bbe4-02be3be6d1cd 43742-0325 HUMAN OTC DRUG Bio Lymphomyosot not applicable LIQUID ORAL 20140829 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARANEUS DIADEMATUS; ASCORBIC ACID; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FLOWERING TOP; MYOSOTIS ARVENSIS; NASTURTIUM AQUATICUM; PINUS SYLVESTRIS LEAFY TWIG; QUERCETIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SCROPHULARIA NODOSA; SMILAX REGELII ROOT; SODIUM SULFATE; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 6; 6; 4; 12; 4; 5; 4; 5; 3; 4; 4; 6; 30; 3; 6; 4; 12; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0326_3bd9a82c-244c-47e8-8973-933e61b901c7 43742-0326 HUMAN OTC DRUG Bio Viscum Compositum not applicable LIQUID ORAL 20140903 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE CYCLIC PHOSPHATE; MERCUROUS IODIDE; SEROTONIN HYDROCHLORIDE; TRYPTOPHAN; VISCUM ALBUM FRUITING TOP 8; 10; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0338_fb611011-bd77-4741-a28a-83481932caf2 43742-0338 HUMAN OTC DRUG Bio Thalamus Compositum not applicable LIQUID ORAL 20140829 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE CYCLIC PHOSPHATE; APIOLE (PARSLEY); LEVODOPA; MELATONIN; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; VISCUM ALBUM FRUITING TOP 6; 6; 6; 6; 8; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0339_5c426ae7-f580-4a4b-8521-0f7149d3fe16 43742-0339 HUMAN OTC DRUG Condylomata Remedy Human papilloma nosode, LIQUID ORAL 20140621 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN PAPILLOMAVIRUS 15 [hp_X]/mL 43742-0340_7ee0521f-12eb-4173-81cb-94d8f5703220 43742-0340 HUMAN OTC DRUG Toxoplasma Gondii Remedy Toxoplasma LIQUID ORAL 20140715 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TOXOPLASMA GONDII 15 [hp_X]/mL 43742-0341_2a23448c-a758-4587-8674-f3e028506903 43742-0341 HUMAN OTC DRUG Elevate RXS Lycopodium clavatum, Natrum muriaticum, Sepia, Belladonna, Causticum, Phosphorus, Sulphur, 5-hydroxytryptophan, Alumina, Silicea, LIQUID ORAL 20140402 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE; ADENOSINE CYCLIC PHOSPHATE; ALCALIGENES FAECALIS; ALUMINUM OXIDE; ATROPA BELLADONNA; CAUSTICUM; COENZYME A; DOPAMINE HYDROCHLORIDE; LACTIC ACID, L-; LYCOPODIUM CLAVATUM SPORE; NOREPINEPHRINE; OXITRIPTAN; PHENETHYLAMINE; PHOSPHORUS; PROTEUS VULGARIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SEPIA OFFICINALIS JUICE; SEROTONIN HYDROCHLORIDE; SILICON DIOXIDE; SODIUM CHLORIDE; SULFUR; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA UMBILICAL CORD 8; 10; 30; 8; 4; 4; 10; 8; 10; 3; 8; 6; 8; 4; 30; 30; 3; 8; 8; 3; 4; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0342_ce2ff262-bfc6-479f-b8fa-541d92b958e7 43742-0342 HUMAN OTC DRUG Neuro I Hydrastis Canadensis, Taraxacum Officinale, Dopamine (Hydrochloride), L-Dopa, Melatonin, Serotonin LIQUID ORAL 20130904 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. DOPAMINE HYDROCHLORIDE; GOLDENSEAL; LEVODOPA; MELATONIN; SEROTONIN HYDROCHLORIDE; TARAXACUM OFFICINALE 6; 3; 6; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0343_37d07a70-49fb-4a5a-853e-bf67fe464d00 43742-0343 HUMAN OTC DRUG Cerebromax Acetylcholine Chloride, Adrenalinum, Dopamine Hydrochloride, Gaba, Norepinephrine, Octopamine, Serotonin (Hydrochloride), Taurine, LIQUID ORAL 20130904 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; ADENOSINE CYCLIC PHOSPHATE; DOPAMINE HYDROCHLORIDE; EPINEPHRINE; NOREPINEPHRINE; OCTOPAMINE; SEROTONIN HYDROCHLORIDE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; TAURINE 6; 6; 8; 6; 6; 6; 6; 6; 8; 8; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0344_4f1f1c36-c842-4ff2-9981-fc3102042ff2 43742-0344 HUMAN OTC DRUG Brain Balance Core Formula Acetylcholine chloride, Dopamine hydrochloride, GABA (Gamma-aminobutyric acid), Octopamine, Serotonin (Hydrochloride), Taurine, LIQUID ORAL 20140515 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; ADENOSINE CYCLIC PHOSPHATE; DOPAMINE HYDROCHLORIDE; OCTOPAMINE; SEROTONIN HYDROCHLORIDE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; TAURINE 6; 6; 8; 6; 6; 6; 8; 8; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0355_a8315230-d83a-497a-968f-b0331484ef28 43742-0355 HUMAN OTC DRUG Perfect Sleep ATP (Adenosine triphosphate disodium), Coenzyme A, Co-enzyme Q-10, Pineal gland (suis), Sarcolacticum acidum, Melatonin, Pyrrole, Tryptophan, TABLET ORAL 20140401 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; COENZYME A; LACTIC ACID, L-; MATRICARIA RECUTITA; MELATONIN; MERCURIC CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; PYRROLE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE; SILICON DIOXIDE; SUS SCROFA PINEAL GLAND; TRYPTOPHAN; UBIDECARENONE; ZINC VALERATE DIHYDRATE 8; 10; 10; 10; 8; 8; 10; 8; 10; 10; 8; 30; 30; 10; 8; 8; 8; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 43742-0356_321088b2-6519-4ba3-b1ff-469d484823d7 43742-0356 HUMAN OTC DRUG Professional Weight Support Asclepias vincetoxicum, Echinacea (angustifolia), Hypothalamus (suis), Hepar suis, Kidney (suis) Methylcobalamin, Gambogia, Graphites, LIQUID ORAL 20140303 UNAPPROVED HOMEOPATHIC Desert Biologicals, Inc. 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; GAMBOGE; GLUCAGON; GRAPHITE; INSULIN HUMAN; LACTIC ACID, L-; METHYLCOBALAMIN; PHYTOLACCA AMERICANA ROOT; PORK KIDNEY; PORK LIVER; PROTEUS VULGARIS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA HYPOTHALAMUS 30; 30; 6; 6; 12; 30; 12; 30; 30; 8; 12; 8; 8; 30; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43742-0357_e3c8730a-3351-49ce-9b52-e175c970bace 43742-0357 HUMAN OTC DRUG BIO GALLIUM NOT APPLICABLE LIQUID ORAL 20141010 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIS MELLIFERA; BETULA PENDULA BARK; CALCIUM FLUORIDE; CALTHA PALUSTRIS; CLEMATIS RECTA FLOWERING TOP; CORTISONE ACETATE; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; GOLD; HEDERA HELIX FLOWERING TWIG; JUNIPER BERRY; NITRIC ACID; ONONIS SPINOSA WHOLE; PHOSPHORUS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; SILVER; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 12; 4; 8; 4; 4; 6; 5; 4; 10; 4; 4; 6; 5; 8; 30; 4; 4; 8; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0360_ba685a36-b078-40de-84f2-ea32b9d5570a 43742-0360 HUMAN OTC DRUG Bio Tonsilla Compositum not applicable LIQUID ORAL 20140829 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE; ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; BARIUM CARBONATE; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; ECHINACEA ANGUSTIFOLIA; FERRUM PHOSPHORICUM; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; HORSE CHESTNUT; LACTIC ACID, L-; MERCURIUS SOLUBILIS; PORK LIVER; PROTORTONIA CACTI; PULSATILLA VULGARIS; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYROID; SUS SCROFA TONSIL; SUS SCROFA UMBILICAL CORD; TRIBASIC CALCIUM PHOSPHATE; YEAST MANNAN 6; 6; 6; 28; 4; 13; 4; 10; 6; 6; 6; 6; 6; 13; 10; 6; 6; 4; 8; 13; 10; 10; 8; 10; 13; 28; 10; 10; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0361_8159d939-03f1-49ec-a869-68f2265e630d 43742-0361 HUMAN OTC DRUG Bio Glyoxal not applicable LIQUID ORAL 20140904 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CORTISONE ACETATE; DOPAMINE HYDROCHLORIDE; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; GLYOXAL; LACHESIS MUTA VENOM; MERCURIC CHLORIDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; PYRUVALDEHYDE; SANGUINARIA CANADENSIS ROOT; SILVER NITRATE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; ZINC 3; 4; 8; 4; 6; 10; 6; 6; 5; 6; 6; 6; 10; 10; 8; 8; 6; 8; 10; 5; 8; 8; 8; 4; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0362_752844f9-5ef3-4247-91d3-735419ba5ad2 43742-0362 HUMAN OTC DRUG BIO CO-ENZYME COMPOSITUM NOT APPLICABLE LIQUID ORAL 20141013 UNAPPROVED HOMEOPATHIC Deseret Biolgicals, Inc. .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ACONITIC ACID, (Z)-; ADENOSINE TRIPHOSPHATE DISODIUM; ANHYDROUS CITRIC ACID; ASCORBIC ACID; BARIUM OXALOSUCCINATE; BETA VULGARIS; CALCIUM SULFIDE; CEROUS OXALATE NONAHYDRATE; COENZYME A; CYSTEINE; EPINEPHRINE; FUMARIC ACID; MAGNESIUM OROTATE; MALIC ACID; MANGANESE PHOSPHATE, DIBASIC; NADIDE; NIACINAMIDE; PROTEUS MORGANII; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SULFUR; THIAMINE HYDROCHLORIDE 8; 8; 8; 10; 8; 6; 30; 4; 10; 8; 8; 6; 6; 8; 8; 8; 16; 8; 6; 30; 6; 6; 6; 6; 8; 8; 10; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0363_fcdf259a-c9c1-4d83-9b91-0b92e0098130 43742-0363 HUMAN OTC DRUG Gallbladder Liver Meridian Formula Cholesterinum, Histaminum Hydrochloricum, Menadione, Pyrrole, Alpha-Lipoicum Acidum, Ascorbic Acid, ATP, Fel Tauri, Gallbladder, Hepar Suis, Sarcolacticum Acidum, Adrenocorticotrophin, Arsencium Album LIQUID ORAL 20131016 UNAPPROVED HOMEOPATHIC Deseret Biologicals .ALPHA.-LIPOIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; ARSENIC TRIOXIDE; ASCORBIC ACID; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; BOS TAURUS BILE; BRYONIA ALBA ROOT; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CORTICOTROPIN; HISTAMINE DIHYDROCHLORIDE; LACTIC ACID, L-; LYCOPODIUM CLAVATUM SPORE; MENADIONE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PORK LIVER; POTASSIUM CARBONATE; PYRROLE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SEPIA OFFICINALIS JUICE; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA GALLBLADDER 6; 6; 30; 6; 30; 30; 6; 30; 6; 30; 30; 8; 6; 6; 30; 6; 30; 30; 6; 30; 6; 30; 30; 30; 30; 30; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0364_4670560f-918e-494a-88ed-7cd39b017f44 43742-0364 HUMAN OTC DRUG Reflux RXS Acetyl coenzyme A, ATP (adenosine triphosphate disodium), Nadidum, Coumarinum, Argentum nitricum, Ipecacuanha, Robinia pseudoacacia, Sulphur, Nux vomica, LIQUID ORAL 20140228 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYL COENZYME A; ADENOSINE TRIPHOSPHATE DISODIUM; ANHYDROUS CITRIC ACID; CENTAURIUM ERYTHRAEA; COUMARIN; FORMIC ACID; HYDROCHLORIC ACID; IPECAC; LACTIC ACID, L-; NADIDE; OREGANO; PEPSIN; PROTEUS MORGANII; ROBINIA PSEUDOACACIA BARK; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; SULFUR; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA STOMACH; SUS SCROFA UMBILICAL CORD 6; 6; 6; 10; 6; 6; 6; 6; 6; 6; 6; 12; 30; 6; 6; 6; 6; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0365_aff67097-56bc-4abd-b104-e85c320c6a5d 43742-0365 HUMAN OTC DRUG HA2CG EVOLUTION Asclepias vincetoxicum, Echinacea (Angustifolia), Hypothalamus (suis), Brain (suis), Hepar suis, Methylcobalamin, Pancreas suis, Kidney (suis), LIQUID ORAL 20140527 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; APC-356433; APC-356434; CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GLUCAGON; GRAPHITE; INSULIN HUMAN; LACTIC ACID, L-; METHYLCOBALAMIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; PORK BRAIN; PORK KIDNEY; PORK LIVER; PROTEUS VULGARIS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PANCREAS; SUS SCROFA STOMACH 30; 30; 8; 8; 6; 6; 12; 12; 30; 12; 30; 30; 8; 12; 12; 8; 8; 8; 30; 12; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0366_a5810439-2173-4cdf-8912-c98effe26fdd 43742-0366 HUMAN OTC DRUG Celeragesic Echinacea (Angustifolia), Echinacea purpurea, Bellis perennis, Calendula officinalis, Hamamelis virginiana, Aconitrum napellus, Chamomilla, Hypericum perforatum, Belladonna, LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ACTIVATED CHARCOAL; ADENOSINE TRIPHOSPHATE DISODIUM; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS VITALBA FLOWER; COENZYME A; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HELIANTHEMUM NUMMULARIUM FLOWER; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; LACTIC ACID, L-; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; NADIDE; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PROTEUS MORGANII; PRUNUS CERASIFERA FLOWER; SUS SCROFA ADRENAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF; UBIDECARENONE 3; 3; 12; 8; 4; 3; 2; 4; 8; 2; 8; 8; 8; 2; 2; 2; 8; 3; 8; 8; 3; 8; 8; 8; 30; 8; 12; 12; 12; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0367_f41b8c64-601b-4cee-bc68-dc17aa1e18b7 43742-0367 HUMAN OTC DRUG Perfect Sleep ATP (adenosine triphosphate disodium), Coenzyme A, Co-enzyme Q-10, Pineal gland (suis), Sarcolacticum acidum, Melatonin, Pyrrole, Tryptophan, LIQUID ORAL 20140331 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; COENZYME A; LACTIC ACID, L-; MATRICARIA RECUTITA; MELATONIN; MERCURIC CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; PYRROLE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE; SILICON DIOXIDE; SUS SCROFA PINEAL GLAND; TRYPTOPHAN; UBIDECARENONE; ZINC VALERATE DIHYDRATE 8; 10; 10; 10; 8; 8; 10; 8; 10; 10; 8; 30; 30; 10; 8; 8; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0368_8b09f1cb-c7bc-494f-a6b0-ede96a4aa148 43742-0368 HUMAN OTC DRUG Human Parvovirus Remedy Parvovirus Nosode (B19) LIQUID ORAL 20140714 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc HUMAN PARVOVIRUS B19 15 [hp_X]/mL 43742-0369_1d2edd8d-f268-4207-9840-26763be85440 43742-0369 HUMAN OTC DRUG Sugar Mix Cinnamic acid, Phloridzinum, Argentum nitricum, ATP (Adenosine triphosphate disodium), Beet sugar, Dextrose, D-ribose, Fructose, Grape sugar (syrup), Lycopodium clavatum, LIQUID ORAL 20140428 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACER SACCHARUM SAP; ADENOSINE TRIPHOSPHATE DISODIUM; CINNAMIC ACID; CORTICOTROPIN HUMAN; DEXTROSE; FRUCTOSE; LACTIC ACID, L-; LACTOSE; LYCOPODIUM CLAVATUM SPORE; MALVIN; PHLORIZIN; RIBOSE, D-; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE; SILVER NITRATE; SUCROSE 6; 6; 6; 8; 6; 6; 6; 6; 6; 15; 6; 6; 30; 30; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0370_4f62cd6f-22a5-4c34-a0d8-10d92d3291b6 43742-0370 HUMAN PRESCRIPTION DRUG Pre Dental Visit Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Arvense, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum LIQUID ORAL 20140709 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARANEUS DIADEMATUS; CLEMATIS VITALBA FLOWER; EQUISETUM ARVENSE TOP; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MYOSOTIS ARVENSIS; NASTURTIUM AQUATICUM; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PINUS SYLVESTRIS LEAFY TWIG; PRUNUS CERASIFERA FLOWER; SARSAPARILLA; SCROPHULARIA NODOSA; SODIUM SULFATE; SUS SCROFA LYMPH; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 12; 8; 4; 12; 4; 5; 4; 8; 8; 5; 5; 3; 4; 8; 4; 8; 6; 3; 4; 12; 12; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 43742-0371_16098273-bb98-4857-8088-f31172c8b3c5 43742-0371 HUMAN OTC DRUG BACTERIA COMBINATION NOT APPLICABLE LIQUID ORAL 20140929 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; APIOLE (PARSLEY); CINNAMIC ACID; ECHINACEA, UNSPECIFIED; ENTEROCOCCUS FAECALIS; ESCHERICHIA COLI; HELICOBACTER PYLORI; LEGIONELLA PNEUMOPHILA; LISTERIA MONOCYTOGENES; MALIC ACID; MYCOPLASMA PNEUMONIAE; OROTIC ACID MONOHYDRATE; PROTEUS MIRABILIS; PROTEUS MORGANII; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; RIBOFLAVIN; SHIGELLA DYSENTERIAE; SHIGELLA SONNEI; SODIUM DIETHYL OXALACETATE; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS EQUINUS; STREPTOCOCCUS MUTANS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PYOGENES; STREPTOCOCCUS UBERIS; STREPTOCOCCUS VIRIDANS GROUP; YERSINIA ENTEROCOLITICA 6; 6; 6; 15; 13; 15; 15; 11; 14; 6; 15; 6; 15; 30; 15; 15; 6; 15; 15; 6; 9; 15; 32; 13; 15; 15; 15; 12; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43742-0372_e0614de5-5f90-4fd2-9060-56f845009450 43742-0372 HUMAN OTC DRUG HGH Vitality Agnus castus, Ambra grisea, Conium maculatum, Apiolum, Estradiol, Estriol, Folliculinum, Ldopa, Melatonin, Testosterone, Alpha-lipoicum acidum, LIQUID ORAL 20140220 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-LIPOIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; AMBERGRIS; APIOLE (PARSLEY); BARIUM CARBONATE; CHASTE TREE; COENZYME A; CONIUM MACULATUM FLOWERING TOP; ESTRADIOL; ESTRIOL; ESTRONE; LACTIC ACID, L-; LEVODOPA; MELATONIN; NADIDE; PORK LIVER; PROTEUS MORGANII; SELENIUM; SOMATROPIN; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA OVARY; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA TESTICLE; SUS SCROFA UMBILICAL CORD; TESTOSTERONE; UBIDECARENONE 8; 8; 6; 6; 8; 6; 8; 6; 6; 6; 6; 8; 6; 6; 8; 30; 30; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0373_37448ccc-a22c-4ed1-960f-2e7063959294 43742-0373 HUMAN OTC DRUG CALCIUM MIX SYSTEM FORMULA NOT APPLICABLE LIQUID ORAL 20141007 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .GAMMA.-AMINOBUTYRIC ACID; ACTIVATED CHARCOAL; APIOLE (PARSLEY); ASPARAGINE; BENZOIC ACID; CALCIUM CITRATE; CALCIUM FLUORIDE; CALCIUM GLUCONATE; CHOLINE HYDROXIDE; CINNAMIC ACID; COUMARIN; ESTRONE; EUGENOL; FOLIC ACID; FORMALDEHYDE; HISTAMINE DIHYDROCHLORIDE; LACTIC ACID, L-; LACTOSE; MATRICARIA RECUTITA; MENADIONE; OCTOPAMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHENYL ISOTHIOCYANATE; PIPERINE; QUERCETIN; RUTIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SUS SCROFA OVARY; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE; VANILLYLAMINE; XANTHINE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43742-0374_106c3605-b197-4c7a-86cd-00a0a19f7e09 43742-0374 HUMAN OTC DRUG STOMACH ACID SYSTEM FORMULA NOT APPLICABLE LIQUID ORAL 20141009 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ANHYDROUS CITRIC ACID; CORTICOTROPIN; COUMARIN; FORMIC ACID; HYDROCHLORIC ACID; LACTIC ACID, L-; NERIUM OLEANDER LEAF; PROTEUS MORGANII; PTELEA TRIFOLIATA BARK; SULFUR 6; 8; 6; 6; 6; 6; 6; 30; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0375_fe71149e-5af1-4b37-8dd0-bcca7d849d27 43742-0375 HUMAN OTC DRUG Sinusitis Plus with ENT Support Kali muriaticum, Calcarea sulphurica, Sulphur, Mucor racemosus, Hydrastis canadensis, Kali bichromicum, Lachesis mutus, Mercurius sulphuratus ruber, LIQUID ORAL 20140428 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; CALCIUM SULFATE ANHYDROUS; CALCIUM SULFIDE; CANDIDA ALBICANS; COBALT; COPPER; GOLDENSEAL; LACHESIS MUTA VENOM; MANGANESE; MERCURIC SULFIDE; MUCOR RACEMOSUS; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; SILICON DIOXIDE; SILVER NITRATE; SINUSITISINUM; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 7; 10; 10; 10; 7; 7; 10; 7; 6; 6; 7; 10; 10; 15; 6; 12 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0376_d204ab7b-9186-45dc-8fa0-5aea9d5b5c7a 43742-0376 HUMAN OTC DRUG VITAMIN C MIX NOT APPLICABLE LIQUID ORAL 20141003 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETALDEHYDE; ACETIC ACID; ARSENIC TRIOXIDE; ASCORBIC ACID; CHLOROPHYLL; CINNAMIC ACID; CORTICOTROPIN; GALLIC ACID MONOHYDRATE; HESPERADIN; LACTIC ACID, L-; MALVIN; OXALIC ACID; QUERCETIN; RUTIN; SHIGELLA DYSENTERIAE 6; 6; 6; 6; 10; 6; 8; 6; 6; 6; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 43742-0377_0f95af02-1c1e-4410-b45a-b6b179805686 43742-0377 HUMAN OTC DRUG Celeragesic Echinacea (Angustifolia), Echinacea purpurea, Bellis perennis, Calendula officinalis, Hamamelis virginiana, Aconitum napellus, Chamomilla, Hypericum perforatum, GEL TOPICAL 20140512 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ACTIVATED CHARCOAL; ADENOSINE TRIPHOSPHATE DISODIUM; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS VITALBA FLOWER; COENZYME A; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HELIANTHEMUM NUMMULARIUM FLOWER; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; LACTIC ACID, L-; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; NADIDE; ORNITHOGALUM UMBELLATUM; PROTEUS MORGANII; PRUNUS CERASIFERA FLOWER; SUS SCROFA ADRENAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF; UBIDECARENONE 3; 3; 12; 8; 4; 3; 2; 4; 8; 2; 8; 8; 8; 2; 2; 2; 8; 3; 8; 8; 3; 8; 8; 8; 30; 8; 12; 12; 12; 6; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43742-0379_42f007fa-330b-4bc8-922e-1406033dcd38 43742-0379 HUMAN OTC DRUG Lymph Spleen Combo Castanea vesca. Juniperus communis, Phytolacca decandra, Quercus glandium spiritus, Myosotis arvensis, Natrum sulphuricum, Ceanothus americanus, LIQUID ORAL 20140218 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; AMBER; APIS MELLIFERA; CASTANEA SATIVA LEAF; CEANOTHUS AMERICANUS LEAF; HELIANTHUS ANNUUS FLOWERING TOP; IRON; JUNIPERUS COMMUNIS WHOLE; MYOSOTIS ARVENSIS; PHYTOLACCA AMERICANA ROOT; QUERCUS ROBUR NUT; QUININE ARSENATE; SODIUM CHLORIDE; SODIUM SULFATE; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; UBIDECARENONE 12; 30; 200; 3; 6; 6; 30; 3; 6; 3; 4; 8; 6; 6; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0380_5a5756d4-aa53-4d19-97cf-ee13bd8a9f79 43742-0380 HUMAN OTC DRUG Governing Vessel Conception Vessel Meridian Formula Phenylalanine, Taurine, Nerve (Suis), Ascorbic acid, ATP (Adenosine triphosphate disodium), Brain (Suis), Sarcolacticum acidum, Adrenocorticotrophin, LIQUID ORAL 20140613 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; APIS MELLIFERA; ARSENIC ACID; ASCORBIC ACID; ATROPA BELLADONNA; BARIUM CARBONATE; CICUTA VIROSA ROOT; CONIUM MACULATUM FLOWERING TOP; CORTICOTROPIN; IRON; LACHESIS MUTA VENOM; LACTIC ACID, L-; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; MALVIN; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHENYLALANINE; PHOSPHORUS; PORK BRAIN; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SHIGELLA DYSENTERIAE; SODIUM SULFATE; SUS SCROFA NERVE; TAURINE; THUJA OCCIDENTALIS LEAFY TWIG 6; 30; 30; 6; 30; 30; 30; 30; 8; 30; 30; 6; 30; 30; 10; 30; 30; 6; 30; 6; 30; 30; 30; 30; 8; 6; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 43742-0381_9ca2e4f2-d17f-4c86-92f8-79ee765f4fe1 43742-0381 HUMAN OTC DRUG Free Radical Alfalfa, Ascorbyl Palmitate, Cysteinum, Hordeum Vulgare, Laminaria Digitata, Manganese Gluconate, Methionine, Nasturtium Aquaticum, N, n Dimethylglycine, Quercetin LIQUID ORAL 20140709 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; .ALPHA.-TOCOPHEROL; ALFALFA; ASCORBYL PALMITATE; BARLEY; COBALT; CYSTEINE; GLUTATHIONE; GLYOXAL TRIMER DIHYDRATE; IRON; LAMINARIA DIGITATA; MAGNESIUM FLUORIDE; MANGANESE GLUCONATE; METHIONINE; N,N-DIMETHYLGLYCINE; NASTURTIUM AQUATICUM; ORYZA SATIVA WHOLE; QUERCETIN; RAPHANUS SATIVUS; SELENIUM; SODIUM SELENITE; UBIDECARENONE; WHEAT; ZINC; ZINC PICOLINATE 30; 8; 8; 6; 6; 6; 12; 6; 12; 30; 12; 6; 12; 6; 6; 6; 6; 8; 6; 6; 12; 6; 6; 6; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0382_5f7a0723-5375-4477-9814-565fd14c4a15 43742-0382 HUMAN OTC DRUG Healing Support Betula Cortex, Caltha Palustris, Galium Aparine, Sedum Acre, Thuja Occidentalis, Urtica urens, Clematis Erecta, Hedera Helix, Juniperus Communis, Quillaja Saponaria, Sempervivum Tectorum, Echinacea, LIQUID ORAL 20131104 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIS MELLIFERA; BETULA PENDULA BARK; CALCIUM FLUORIDE; CALTHA PALUSTRIS; CLEMATIS RECTA FLOWERING TOP; ECHINACEA, UNSPECIFIED; GALIUM APARINE; HEDERA HELIX FLOWERING TWIG; JUNIPERUS COMMUNIS WHOLE; NITRIC ACID; ONONIS SPINOSA ROOT; PHOSPHORUS; QUILLAJA SAPONARIA BARK; RANCID BEEF; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; SILVER; THUJA OCCIDENTALIS LEAF; URTICA URENS 12; 2; 8; 3; 4; 5; 3; 4; 4; 6; 5; 8; 4; 12; 3; 4; 8; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0393_f9b0c682-1153-4c92-af68-91a0e40228fa 43742-0393 HUMAN OTC DRUG Immune Support Echinacea (Angustifolia), Aconitum napellus, Arnica Montana, Baptisia tinctoria, Rhus toxicodendron, Sanguinaria canadensis, Aristolochia clematitis, Bryonia (alba), LIQUID ORAL 20140428 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITUM NAPELLUS; ARISTOLOCHIA CLEMATITIS ROOT; ARNICA MONTANA; ARSENIC ACID; ASTRAGALUS NUTTALLII LEAF; ATROPA BELLADONNA WHOLE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CORTISONE ACETATE; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); LACHESIS MUTA VENOM; MERCURIC CHLORIDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RANCID BEEF; SANGUINARIA CANADENSIS ROOT; SILVER NITRATE; SULFUR; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP; ZINC 3; 6; 4; 8; 12; 12; 4; 6; 10; 13; 2; 6; 6; 6; 12; 12; 12; 10; 6; 8; 6; 8; 200; 4; 8; 8; 12; 12; 8; 4; 12; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0394_6dbb0743-3d33-46b5-be8b-a9c99cb92e24 43742-0394 HUMAN OTC DRUG PHLORIDZIN NOT APPLICABLE LIQUID ORAL 20140929 UNAPPROVED HOMEOPATHIC Deseret Biologicals PHLORIZIN 6 [hp_X]/mL 43742-0395_dfe06236-7031-4251-ad2f-2240a0284257 43742-0395 HUMAN OTC DRUG VITAMIN A MIX NOT APPLICABLE LIQUID ORAL 20141007 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ASPARAGINE; BETA CAROTENE; CORTICOTROPIN; ENTEROBACTER CLOACAE; HISTAMINE DIHYDROCHLORIDE; LACTIC ACID, L-; OCTOPAMINE; POTASSIUM IODIDE; PROTEUS VULGARIS; SODIUM CHLORIDE; TYRAMINE; VITAMIN A PALMITATE 6; 6; 8; 30; 4; 6; 6; 6; 30; 6; 6; 6 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 43742-0396_39e65991-5456-418d-9b68-d543fe9586b4 43742-0396 HUMAN OTC DRUG Bacteria Plus ATP, Malic acid, Natrum oxalaceticum, Oroticum acidum, Roboflavinum, Apiolum, Cinnamic acid, Streptococcus viridans, Colibacillinum cum naturm muriaticum, Echinacea, LIQUID ORAL 20140207 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE; APIOLE (PARSLEY); CINNAMIC ACID; ECHINACEA ANGUSTIFOLIA; ENTEROCOCCUS FAECALIS; ESCHERICHIA COLI; HELICOBACTER PYLORI; LEGIONELLA PNEUMOPHILA; LISTERIA MONOCYTOGENES; MALIC ACID; MYCOPLASMA PNEUMONIAE; OROTIC ACID MONOHYDRATE; PROTEUS MIRABILIS; PROTEUS MORGANII; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; RIBOFLAVIN; SHIGELLA DYSENTERIAE; SHIGELLA SONNEI; SODIUM DIETHYL OXALACETATE; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS EQUINUS; STREPTOCOCCUS MUTANS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PYOGENES; STREPTOCOCCUS UBERIS; STREPTOCOCCUS VIRIDANS GROUP; YERSINIA ENTEROCOLITICA 6; 6; 6; 15; 13; 15; 15; 11; 14; 6; 15; 6; 15; 30; 15; 15; 6; 15; 15; 6; 9; 15; 15; 13; 15; 15; 15; 12; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43742-0400_90e924d5-3e64-4b40-a607-0961ce209b2f 43742-0400 HUMAN OTC DRUG Pertussis Aconitum napellus, Antimonium tartaricum, Belladonna, Bryonia (Alba), Hyoscyamus niger, Ipecacuanha, Lobelia inflata, Sticta pulmonaria, Phosphorus, LIQUID ORAL 20140612 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CLOSTRIDIUM TETANI; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; HYOSCYAMUS NIGER; IPECAC; LOBARIA PULMONARIA; LOBELIA INFLATA; PHOSPHORUS; SILICON DIOXIDE; WOOD CREOSOTE 4; 4; 4; 4; 30; 30; 4; 4; 4; 4; 5; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0402_82229ff8-7cad-4d85-a90e-e4df27fd991a 43742-0402 HUMAN OTC DRUG Bio Co-Enzyme Phase Beta vulgaris, Ascrobic acid, Cysteinum, Natrum oxalaceticum, nicotinamidum, Pulsatilla (vulgaris), Pyridoxinum hydrochloricum, Riboflavinum, LIQUID ORAL 20140331 UNAPPROVED HOMEOPATHIC Deseret Biolgicals, Inc. .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ACONITIC ACID, (Z)-; ADENOSINE TRIPHOSPHATE DISODIUM; ANHYDROUS CITRIC ACID; ASCORBIC ACID; BARIUM OXALOSUCCINATE; BETA VULGARIS; CALCIUM SULFIDE; CEROUS OXALATE NONAHYDRATE; COENZYME A; CYSTEINE; EPINEPHRINE; FUMARIC ACID; MAGNESIUM OROTATE; MALIC ACID; MANGANESE PHOSPHATE, DIBASIC; NADIDE; NIACINAMIDE; PROTEUS MORGANII; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SULFUR; THIAMINE HYDROCHLORIDE 8; 8; 8; 10; 8; 6; 30; 4; 10; 8; 8; 6; 6; 8; 8; 8; 16; 8; 6; 30; 6; 6; 6; 6; 8; 8; 10; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0403_73a1aa0f-b40b-4604-bf11-b8b076fa02ab 43742-0403 HUMAN OTC DRUG Dopamine Dopamine Hydrochloride LIQUID ORAL 20140314 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. DOPAMINE HYDROCHLORIDE 6 [hp_X]/mL 43742-0404_8fdc4ec4-fcf8-43cb-a0d1-f158b5fdc3ca 43742-0404 HUMAN OTC DRUG Bio Galium Phase Betula (Pendula), cortex, Caltha palustris, Clematis erecta, Galium aparine, Hedera helix, Juniperus comminis, Sedum acre, Sempervivum tectorum, Thuja occidentalis, LIQUID ORAL 20140520 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIS MELLIFERA; BETULA PENDULA BARK; CALCIUM FLUORIDE; CALTHA PALUSTRIS; CLEMATIS RECTA FLOWERING TOP; CORTISONE ACETATE; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; GOLD; HEDERA HELIX FLOWERING TWIG; JUNIPER BERRY; NITRIC ACID; ONONIS SPINOSA WHOLE; PHOSPHORUS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; SILVER; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 12; 4; 8; 4; 4; 6; 5; 4; 10; 4; 4; 6; 5; 8; 30; 4; 4; 8; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0405_c71554c4-efc8-4a34-a26d-c592b28ad0a9 43742-0405 HUMAN OTC DRUG Bio Glyoxal Phase Aconitum napellus, Arnica montana, Baptisia tinctoria, Rhus toxicodendron, Echinacea (angustifolia), Sanguinaria canadensis, Bryonia (alba), Eupatorium perfoliatum, LIQUID ORAL 20140401 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CORTISONE ACETATE; DOPAMINE HYDROCHLORIDE; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; GLYOXAL TRIMER DIHYDRATE; LACHESIS MUTA VENOM; MERCURIC CHLORIDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; PYRUVALDEHYDE; SANGUINARIA CANADENSIS ROOT; SILVER NITRATE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; ZINC 3; 4; 8; 4; 6; 10; 6; 6; 5; 6; 6; 6; 10; 10; 8; 8; 6; 8; 10; 5; 8; 8; 8; 4; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0406_6872b69e-ef8f-4670-8d98-6b82fa9905ce 43742-0406 HUMAN OTC DRUG Bio Lymph Phase Myosotis arvensis, Scrophularia nodosa, Teucrium scorodonia, Veronica officinalis, Equisetum hyemale, Fumaria officinalis, Geranium robertianum, Nasturtium aquaticum, LIQUID ORAL 20140429 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARANEUS DIADEMATUS; ASCORBIC ACID; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS NIGRA LEAF; JUGLANS REGIA FRUIT RIND, IMMATURE; MYOSOTIS ARVENSIS; NASTURTIUM AQUATICUM; PINUS SYLVESTRIS LEAFY TWIG; QUERCETIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SARSAPARILLA; SCROPHULARIA NODOSA; SODIUM SULFATE; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 6; 6; 4; 12; 4; 5; 4; 5; 5; 3; 4; 4; 6; 30; 6; 3; 4; 12; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0407_75e6fcdc-df68-4dae-b26f-b04f846028d9 43742-0407 HUMAN OTC DRUG Bio Placenta Phase Aesculus hippocastanum, Sarcolacticum acidum, Secale cornutum, Cuprum sulphuricum, Melilotus officinalis, Placenta totalis suis, Solanum nigrum, LIQUID ORAL 20140522 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BARIUM CARBONATE; CLAVICEPS PURPUREA SCLEROTIUM; CUPRIC SULFATE; HORSE CHESTNUT; LACTIC ACID, L-; LEAD IODIDE; MELILOTUS OFFICINALIS TOP; PRASTERONE; PROTEUS VULGARIS; QUERCETIN; RUTIN; SODIUM PYRUVATE; SOLANUM NIGRUM WHOLE; STROPHANTHUS HISPIDUS SEED; SUS SCROFA ARTERY; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; SUS SCROFA VEIN; TOBACCO LEAF; VIPERA BERUS VENOM 13; 4; 6; 4; 4; 18; 6; 12; 30; 12; 6; 8; 6; 6; 10; 6; 10; 8; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0408_77dac09d-29ac-402d-814b-99be35139aec 43742-0408 HUMAN OTC DRUG Bio Thalamus Phase Adenosinum cyclophosphoricum, Apiolum, L-DOPA, Melatonin, Pineal (Suis), Thalamus opticus (Suis), Viscum album, LIQUID ORAL 20140612 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE CYCLIC PHOSPHATE; APIOLE (PARSLEY); LEVODOPA; MELATONIN; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; VISCUM ALBUM FRUITING TOP 6; 6; 6; 6; 8; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0409_1dbe0877-a7ff-4096-bf01-7e9bb4e2290c 43742-0409 HUMAN OTC DRUG Bio Tonsilla Phase Conium maculatum, Dulcamara, Echinacea (Angustifolia), Aesculus hippocastanum, Antimonium tartaricum, Ascorbic acid, Coccus cacti, Galium aparine, LIQUID ORAL 20140501 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE; ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; BARIUM CARBONATE; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; ECHINACEA ANGUSTIFOLIA; FERRUM PHOSPHORICUM; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; HORSE CHESTNUT; LACTIC ACID, L-; MERCURIUS SOLUBILIS; PORK LIVER; PROTORTONIA CACTI; PULSATILLA VULGARIS; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYROID; SUS SCROFA TONSIL; SUS SCROFA UMBILICAL CORD; TRIBASIC CALCIUM PHOSPHATE; YEAST MANNAN 6; 6; 6; 28; 4; 13; 4; 10; 6; 6; 6; 6; 6; 13; 10; 6; 6; 4; 8; 13; 10; 10; 8; 10; 13; 28; 10; 10; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0410_7db2ff73-af00-4f45-87b9-3b783a276327 43742-0410 HUMAN OTC DRUG Bio Viscum Phase Viscum Album, Serotonin, Tryptophan, Adenosinum Cyclophosphoricum, Mercurius Iodatus Flavus LIQUID ORAL 20140715 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE CYCLIC PHOSPHATE; MERCUROUS IODIDE; SEROTONIN HYDROCHLORIDE; TRYPTOPHAN; VISCUM ALBUM FRUITING TOP 8; 10; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0411_9496efee-762f-4985-8b8d-af230d85df9e 43742-0411 HUMAN OTC DRUG BIO MOOD PHASE NOT APPLICABLE LIQUID ORAL 20141010 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHAMAELIRIUM LUTEUM ROOT; CORTISONE ACETATE; ENTEROBACTER CLOACAE; EPINEPHRINE; GOLD; HYPERICUM PERFORATUM; POTASSIUM PHOSPHATE, DIBASIC; QUININE ARSENATE; SELENIUM; STRYCHNOS NUX-VOMICA SEED 10; 6; 30; 6; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0412_f0f1ee0b-d820-42a4-aaa3-61df9e7f0963 43742-0412 HUMAN OTC DRUG Chronagesic Dulcamara, Arnica montana, Rhus toxicodendron, Sanguinaria canadensis, Cartilago suis, Coenzyme A, Funiculus umbilicalis suis, Nadidum, Natrum oxalaceticum, LIQUID ORAL 20140401 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-LIPOIC ACID; APIOLE (PARSLEY); ARNICA MONTANA; CHONDROITIN SULFATE SODIUM (BOVINE); CINNAMIC ACID; COENZYME A; COMFREY ROOT; DIMETHYL SULFONE; ENTEROCOCCUS FAECALIS; MENADIONE; NADIDE; PIPERINE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SOLANUM DULCAMARA TOP; SOMATROPIN; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF 8; 6; 3; 6; 6; 6; 8; 6; 30; 6; 6; 6; 30; 3; 8; 6; 2; 30; 6; 6; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0413_20088711-5a9b-4166-9441-ea3a6d3a6cf0 43742-0413 HUMAN OTC DRUG Sinusitis Pulsatilla (vulgaris) Plantago major, Euphorbium officinarum, Luffa operculata, Mercurius iodatus ruber, Mucosa nasalis suis, LIQUID ORAL 20140416 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CALCIUM SULFIDE; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILVER NITRATE; SINUSITISINUM; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA 10; 4; 6; 8; 12; 3; 2; 10; 18; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0414_1cfecf88-0199-4850-ba88-41112fcc447e 43742-0414 HUMAN OTC DRUG Focus RXS Alpha-ketoglutaricum acidum, ATP (Adenosine triphosphate disodium), Formicum acidum, Malic acid, Sarcolacticum acidum, Dulcamara, Hyoscyamus niger, LIQUID ORAL 20140403 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-KETOGLUTARIC ACID; .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; ADENOSINE CYCLIC PHOSPHATE; ADENOSINE TRIPHOSPHATE DISODIUM; ARSENIC TRIOXIDE; ATROPA BELLADONNA; DOPAMINE; EPINEPHRINE; FORMIC ACID; HYOSCYAMUS NIGER; JUNIPERUS SABINA LEAFY TWIG; LACTIC ACID, L-; LYCOSA TARANTULA; MALIC ACID; NOREPINEPHRINE; OCTOPAMINE; PHENETHYLAMINE; PHOSPHORUS; PORK BRAIN; SEROTONIN HYDROCHLORIDE; SHIGELLA DYSENTERIAE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA BRAINSTEM; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; TAURINE; TYRAMINE; VALERIAN; VERATRUM ALBUM ROOT 6; 6; 6; 8; 6; 30; 30; 6; 6; 6; 6; 6; 6; 30; 6; 6; 6; 6; 6; 8; 6; 30; 8; 6; 30; 8; 8; 8; 8; 8; 6; 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 43742-0415_ddb1e6a6-ed75-4c7c-9290-0ecd7c2448e5 43742-0415 HUMAN OTC DRUG Stomach Spleen Meridian Formula not applicable LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE; ARSENIC TRIOXIDE; ASCORBIC ACID; CEANOTHUS AMERICANUS LEAF; CINCHONA OFFICINALIS BARK; CORTISONE ACETATE; DIGITALIS; HISTAMINE DIHYDROCHLORIDE; HYDROCORTISONE; LACTIC ACID, L-; LEAD; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; RANUNCULUS BULBOSUS; RIBOFLAVIN; SHIGELLA DYSENTERIAE; STRYCHNOS IGNATII SEED; SUS SCROFA SPLEEN; SUS SCROFA STOMACH; VERATRUM VIRIDE ROOT 6; 30; 6; 30; 30; 12; 30; 6; 6; 6; 30; 30; 30; 30; 30; 30; 30; 6; 30; 6; 30; 30; 6; 6; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0418_c4b25492-031e-41b5-b88b-329bc4475aaa 43742-0418 HUMAN OTC DRUG FNG Berberis vulgaris, Cochlearia armoracia, Echineacea (angustifolia), Hydrastis canadensis, Lomatium dissectum, Myrrha, Tabebuia impetiginosa, Propolis, LIQUID ORAL 20140327 UNAPPROVED HOMEOPATHIC Deseret Biologicals ADENOSINE TRIPHOSPHATE DISODIUM; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BERBERIS VULGARIS ROOT BARK; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA ANGUSTIFOLIA; ESCHERICHIA COLI; FORMALDEHYDE; GOLDENSEAL; HORSERADISH; IRIDIUM; IRON; LACTIC ACID, L-; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; METHYLCOBALAMIN; MUCOR RACEMOSUS; MYRRH; PHOSPHORIC ACID; PROPOLIS WAX; PULSATILLA VULGARIS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; SELENIUM; STACHYBOTRYS CHARTARUM; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; ZINC 12; 12; 12; 12; 3; 12; 12; 3; 30; 6; 3; 3; 12; 12; 12; 3; 12; 12; 12; 3; 12; 6; 12; 12; 12; 12; 12; 8; 8; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0419_ecd3d2b7-4e79-478f-a3e9-7d183938ee88 43742-0419 HUMAN OTC DRUG LYME PLUS NOT APPLICABLE LIQUID ORAL 20141104 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACTIVATED CHARCOAL; ANAMIRTA COCCULUS SEED; ARNICA MONTANA; ARSENIC TRIOXIDE; BORRELIA BURGDORFERI; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GOLDENSEAL; HEPATITIS B VIRUS; IRIDIUM; JAPANESE ENCEPHALITIS VIRUS; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; MYRRH; NEISSERIA MENINGITIDIS; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM NITRATE; PROPOLIS WAX; SULFUR; SUS SCROFA THYMUS; SUS SCROFA THYROID; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; TRIGONELLA FOENUM-GRAECUM WHOLE; URTICA DIOICA 8; 12; 3; 12; 15; 3; 3; 8; 3; 33; 12; 15; 30; 12; 3; 30; 12; 3; 8; 6; 8; 8; 8; 3; 12; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0420_2355a663-dcab-4370-b465-17d5121268cd 43742-0420 HUMAN OTC DRUG Energize RXS Sarcolacticum acidum, Viscum album, Iodium, Colchicum autumnale, Conium, maculatum, Fucus vesiculosus, Galium aparine, Natrum oxalaceticum, LIQUID ORAL 20140214 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-KETOGLUTARIC ACID; ADENOSINE TRIPHOSPHATE; CALCIUM FLUORIDE; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; ESCHERICHIA COLI; FUCUS VESICULOSUS; FUMARIC ACID; GALIUM APARINE; IODINE; LACTIC ACID, L-; LIOTHYRONINE; MALIC ACID; MERCURIC CHLORIDE; PHENYL ISOTHIOCYANATE; PORK LIVER; PRASTERONE; PULSATILLA VULGARIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SODIUM DIETHYL OXALACETATE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA BONE MARROW; SUS SCROFA PINEAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; SUS SCROFA UMBILICAL CORD; THYROID, PORCINE; TYRAMINE; VISCUM ALBUM FRUITING TOP 7; 7; 12; 6; 6; 30; 30; 6; 7; 6; 3; 3; 6; 7; 60; 6; 8; 6; 12; 30; 6; 12; 8; 8; 8; 8; 8; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0421_0fcb0154-8ef2-4e10-b909-cbf0615c2f22 43742-0421 HUMAN OTC DRUG Aspartame MSG Detox Chelidonium majus, Phytolacca decandra, Arnica montana, Nitricum acidum, Nux vomica, Phosphoricum acidum, Bisphenol A (BPA), Dextrose, LIQUID ORAL 20140613 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. 2,5-PIPERAZINEDIONE; ARNICA MONTANA; ASPARTIC ACID; BISPHENOL A; CHELIDONIUM MAJUS; DEXTROSE; DOPAMINE HYDROCHLORIDE; FORMALDEHYDE; FORMIC ACID; MALTODEXTRIN; METHYL ALCOHOL; MONOSODIUM GLUTAMATE; NITRIC ACID; PHENYLALANINE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; STRYCHNOS NUX-VOMICA SEED; SUCRALOSE 30; 6; 30; 12; 3; 12; 30; 30; 30; 12; 30; 30; 12; 30; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0422_68b77d43-0b2b-41de-8836-5b926d16c609 43742-0422 HUMAN OTC DRUG MANNAN NOT APPLICABLE LIQUID ORAL 20141013 UNAPPROVED HOMEOPATHIC Deseret Biolgicals, Inc. YEAST MANNAN 6 [hp_X]/mL 43742-0423_c8ba941a-1ce8-4e6d-a35e-9b055e5bf7a3 43742-0423 HUMAN OTC DRUG EBV/CFS Plus Baptisia tinctoria, Condurango, Echinacea (angustifolia), Hydrastis canadensis, Nasturtium aquaticum, OSHA, Phytolacca decandra, Tabebuia impetiginosa, Astragalus menziesii, LIQUID ORAL 20140325 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARANEUS DIADEMATUS; ASTRAGALUS NUTTALLII LEAF; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HUMAN HERPESVIRUS 4; HYDROCHLORIC ACID; IPECAC; LIGUSTICUM PORTERI ROOT; LYCOPODIUM CLAVATUM SPORE; MARSDENIA CONDURANGO BARK; MERCURIUS SOLUBILIS; NASTURTIUM OFFICINALE; NITRIC ACID; PHYTOLACCA AMERICANA ROOT; PROPOLIS WAX; SELENIUM; SILICON DIOXIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; TOXICODENDRON PUBESCENS LEAF 12; 6; 3; 3; 12; 3; 30; 12; 12; 3; 12; 3; 12; 3; 12; 3; 6; 12; 12; 8; 8; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0434_6f613e4a-4988-4fb4-9ad4-80ff8696ee2f 43742-0434 HUMAN OTC DRUG Rheumatoid Arthritis Nosode ATP (Adenosine Triphosphate Disodium), Malic Acid, Natrum Oxalaceticum, Riboflavinum, Apiolum, Cinnamic Acid, DHEA (Dehydroepiandrosterone), Streptococcus viridans LIQUID ORAL 20140711 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; APIOLE (PARSLEY); BORRELIA BURGDORFERI; BRUCELLA ABORTUS; CAMPYLOBACTER JEJUNI; CHLAMYDIA TRACHOMATIS; CINNAMIC ACID; ENTEROCOCCUS FAECALIS; KLEBSIELLA PNEUMONIAE; MALIC ACID; MYCOPLASMA PNEUMONIAE; OROTIC ACID MONOHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PRASTERONE; PROTEUS MORGANII; RIBOFLAVIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE; SHIGELLA SONNEI; SODIUM DIETHYL OXALACETATE; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS EQUINUS; STREPTOCOCCUS MUTANS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PYOGENES; STREPTOCOCCUS UBERIS; STREPTOCOCCUS VIRIDANS GROUP; YERSINIA ENTEROCOLITICA 6; 6; 15; 15; 15; 15; 6; 13; 15; 6; 15; 6; 15; 6; 30; 6; 14; 15; 15; 6; 9; 15; 32; 13; 17; 15; 15; 12; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43742-0436_96cc27b2-4492-4b3a-b553-702d3d4092bc 43742-0436 HUMAN OTC DRUG Peptostrep Remedy Peptostreptococcus anaerobius, LIQUID ORAL 20140621 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PEPTOSTREPTOCOCCUS ANAEROBIUS 19 [hp_X]/mL 43742-0437_60667616-46b5-4abd-bb6c-b1719f96644e 43742-0437 HUMAN PRESCRIPTION DRUG Bio Psorinum Phase Oleander, Cicuta virosa, Sulphur, Thuja occidentalis, Hydrocortisone (cortisol), Vaccinium myrtillus, Bufo rana, Psorinum, Aconitum napellus, Bryonia (alba), LIQUID ORAL 20140304 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITUM NAPELLUS; BILBERRY; BRYONIA ALBA ROOT; BUFO BUFO CUTANEOUS GLAND; CALCIUM SULFATE ANHYDROUS; CICUTA VIROSA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CLAVICEPS PURPUREA SCLEROTIUM; ENTEROCOCCUS FAECALIS; ESCHERICHIA COLI; GONORRHEAL URETHRAL SECRETION HUMAN; HUMAN BREAST TUMOR CELL; HYDROCORTISONE; NERIUM OLEANDER LEAF; SCABIES LESION LYSATE (HUMAN); SODIUM CHLORIDE; SULFUR; THUJA OCCIDENTALIS LEAF; TREPONEMIC SKIN CANKER HUMAN 12; 8; 12; 10; 12; 5; 12; 12; 30; 12; 12; 12; 6; 4; 10; 12; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 43742-0448_afcd90c5-e971-48ca-98fe-c8523288bbee 43742-0448 HUMAN OTC DRUG PEMF Optimizer Aqua sulis, Argentum metallicum, Aurum metallicum, Cuprum metallicum, Lapis albus, Manganum metallicum Vanadium Metallicum Viscum album, Zincum metallicum, LIQUID ORAL 20140623 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CALCIUM HEXAFLUOROSILICATE; COPPER; GOLD; MANGANESE; SILVER; VANADIUM; VISCUM ALBUM FRUITING TOP; WATER; ZINC 1; 1; 1; 1; 1; 1; 1; 30; 1 [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_C]/mL; [hp_M]/mL 43742-0449_5f6f1402-60e2-4ec8-bf05-8c55751146ca 43742-0449 HUMAN OTC DRUG Bronchial Cough Coccus cacti, Drosera (Rotundifolia), Scilla maritima, Stica pulmonaria, Arsenicum iodatum, Causticum, Cuprum aceticum, Carbo vegetabilis, Kali carbonicum, Lachesis mutus, LIQUID ORAL 20140501 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACTIVATED CHARCOAL; ARSENIC TRIIODIDE; CAUSTICUM; CUPRIC ACETATE; DRIMIA MARITIMA BULB; DROSERA ROTUNDIFOLIA; LACHESIS MUTA VENOM; LOBARIA PULMONARIA; POTASSIUM CARBONATE; PROTORTONIA CACTI 12; 6; 6; 6; 4; 4; 12; 4; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0452_083768c6-c5ee-4b90-9e1b-34daad7b708e 43742-0452 HUMAN OTC DRUG Breathe RxS Aconitum napellus, Argentum nitricum, Arsenicum album, Natrum murriaticum, Rhus toxicodendron, Sulphur, Adenosinum cyclophosphoricum, Coenzyme A, Funiculus umbilicalis suis, LIQUID ORAL 20140311 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE; ACONITUM NAPELLUS; ADENOSINE CYCLIC PHOSPHATE; ARSENIC TRIOXIDE; COENZYME A; COUMARIN; LACTIC ACID, L-; MALVIN; PROTEUS MORGANII; SHIGELLA DYSENTERIAE; SILVER NITRATE; SODIUM CHLORIDE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF 6; 6; 10; 6; 10; 6; 10; 15; 30; 30; 6; 6; 6; 10; 10; 10; 10; 6 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0453_ed60bef7-dd2c-4c98-a204-ba576a96611c 43742-0453 HUMAN OTC DRUG EMF Protect and Balance Alfalfa, Laminaria digitata, Symphytum officinale, Ascorbic acid, Melatonin, Calcarea carbonica, Cuprum metallicum, Ferrum metallicum, Iodium, LIQUID ORAL 20140318 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITUM NAPELLUS; ALCOHOL, X-RAY EXPOSED (1000 RAD); ALFALFA; ARSENIC TRIOXIDE; ASCORBIC ACID; CARBON DIOXIDE; COMFREY ROOT; COPPER; IODINE; IRON; LAMINARIA DIGITATA; MANGANESE ACETATE TETRAHYDRATE; MELATONIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SILICON; SILICON DIOXIDE 30; 8; 3; 30; 6; 30; 3; 8; 8; 8; 3; 8; 6; 8; 8; 30; 30; 8; 12 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43742-0455_bbc7e424-8db5-405f-81a0-c89edc9a8927 43742-0455 HUMAN OTC DRUG Radiation Protect Chondrus crispus, Fucus vesiculosus, Thyroidinum (suis), Cadmium iodatum, Cadmium sulphuratum, Iodium, Uranium nitricum, Radium bromatum, LIQUID ORAL 20140325 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALCOHOL, X-RAY EXPOSED (1000 RAD); ARNICA MONTANA; CADMIUM IODIDE; CADMIUM SULFIDE; CHONDRUS CRISPUS; FUCUS VESICULOSUS; IODINE; RADIUM BROMIDE; STRONTIUM CARBONATE; SUS SCROFA THYROID; URANYL NITRATE HEXAHYDRATE 30; 30; 12; 12; 3; 3; 12; 12; 12; 8; 12 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0456_bdc9b3d9-783d-4993-97fc-e15f6b02dcc5 43742-0456 HUMAN OTC DRUG Appetite Control Thyroidinum, Cortisone Aceticum, Anacardium Orentale, Antimonium Crudum, Ignatia Amara, LIQUID ORAL 20140311 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ANTIMONY TRISULFIDE; CORTISONE ACETATE; DELPHINIUM STAPHISAGRIA SEED; HYDROCORTISONE; SEMECARPUS ANACARDIUM JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THYROID, PORCINE 15; 12; 18; 30; 15; 15; 15; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43742-0457_199bdbc6-d87f-4244-81fa-df413cea93f3 43742-0457 HUMAN OTC DRUG Intestinal Distress Echinacea (angustifolia), Colchicum autumnale, Aloe socotrina, Colocynthis, Mercurius corrosivus, Nux vomica, Arsenicum album, Chininum sulphuricum, LIQUID ORAL 20140318 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALOE; ARSENIC TRIOXIDE; BOTULINUM TOXIN TYPE A; CAMPYLOBACTER JEJUNI; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; ECHINACEA ANGUSTIFOLIA; ESCHERICHIA COLI; HELICOBACTER PYLORI; MERCURIC CHLORIDE; QUININE SULFATE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SHIGELLA DYSENTERIAE; STRYCHNOS NUX-VOMICA SEED; VIBRIO CHOLERAE; YERSINIA ENTEROCOLITICA 6; 6; 30; 30; 6; 4; 3; 30; 30; 6; 12; 30; 30; 6; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0458_6abb7ad7-da84-4ed1-adf1-a6566fd92b01 43742-0458 HUMAN OTC DRUG Lymphoplus Trifolium pratense, Lymph (suis), Spleen (suis), Conium maculatum, Echinacea (angustifolia), Lycopodium clavatum, Myrrha, Phytolacca decandra, LIQUID ORAL 20140324 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; LYCOPODIUM CLAVATUM SPORE; MYRRH; PHYTOLACCA AMERICANA ROOT; SELENIUM; SILICON DIOXIDE; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; TRIFOLIUM PRATENSE FLOWER 12; 12; 12; 12; 12; 12; 12; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0469_01854e6e-c75c-4b16-a1e7-c3ba0bfb92fb 43742-0469 HUMAN OTC DRUG Prostate Petroselinum stivum, Populus tremuloides, Sabal serrulata, Chimaphila umbellata, ATP (Adenosine triphosphate disodium), Equol, Kreosotum, LIQUID ORAL 20140320 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; CALCIUM SULFIDE; CHIMAPHILA UMBELLATA; CONIUM MACULATUM FLOWERING TOP; EQUOL, (+/-)-; NADIDE; PETROSELINUM CRISPUM; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; PROTEUS MIRABILIS; PROTEUS VULGARIS; SAW PALMETTO; SUCCINIC ACID; SUS SCROFA PROSTATE; TESTOSTERONE; WOOD CREOSOTE 6; 10; 5; 30; 6; 6; 4; 4; 4; 30; 30; 4; 8; 11; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0470_182a0131-20ee-4619-856d-0f1b30f8bd98 43742-0470 HUMAN OTC DRUG Female Support Chamomilla, Cimicifuga Racemosa, Cinchona Officinalis, Convallaria Majalis, Crocus Sativus, Helonias Dioica LIQUID ORAL 20140319 UNAPPROVED HOMEOPATHIC Deseret Biological, Inc. BLACK COHOSH; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; CINCHONA OFFICINALIS BARK; CINNAMON; CONVALLARIA MAJALIS; CYCLAMEN PURPURASCENS TUBER; DELPHINIUM STAPHISAGRIA SEED; GOLDENSEAL; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; LEDUM PALUSTRE TWIG; LILIUM LANCIFOLIUM WHOLE FLOWERING; MATRICARIA RECUTITA; MENTHA PIPERITA; NAJA NAJA VENOM; SAFFRON; SENNA LEAF; VALERIAN; VIOLA ODORATA 3; 3; 4; 3; 12; 3; 6; 4; 3; 12; 4; 4; 3; 3; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0472_a9e9541b-626e-4a62-8c3a-64ef4b1b7d5f 43742-0472 HUMAN OTC DRUG Inflammation Eupatorium perfoliatim, Arnica montana, Benzoicum acidum, Echinacea (angustifolia), Mercurialis perennis, Apis mellifica, Baptisia tinctoria, LIQUID ORAL 20140321 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIS MELLIFERA; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; BENZOIC ACID; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; ECHINACEA ANGUSTIFOLIA; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; MERCURIALIS PERENNIS; SOLANUM DULCAMARA TOP; SOLANUM NIGRUM WHOLE; TOXICODENDRON PUBESCENS LEAF 4; 3; 4; 3; 4; 4; 3; 4; 2; 3; 4; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0473_a6a435d0-4d9c-416b-8bad-a26ab8b1d08a 43742-0473 HUMAN OTC DRUG Clostridium Difficile Remedy Clostridium difficile, LIQUID ORAL 20140423 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CLOSTRIDIUM DIFFICILE 15 [hp_X]/mL 43742-0485_d4712da4-bcfa-4a63-8812-96621418d2f7 43742-0485 HUMAN OTC DRUG Candida Plus Echinacea (Angustifolia), Hydrastis canadensis, Phytolacca decandra, Alternaria tenuis, Aspergillus niger, Geotrichum candidum, Mucor racemosus, Pullularia pullulans, Rhizopus nigricans, LIQUID ORAL 20140520 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETALDEHYDE; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CAFFEIC ACID; CANDIDA ALBICANS; ECHINACEA ANGUSTIFOLIA; GALLIC ACID MONOHYDRATE; GEOTRICHUM CANDIDUM; GOLDENSEAL; INDOLE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; MUCOR RACEMOSUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE; YEAST MANNAN 6; 6; 6; 6; 6; 12; 3; 6; 6; 3; 6; 12; 12; 6; 3; 12; 6; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0486_d63b12aa-7a96-4ccc-919f-9d262c54828a 43742-0486 HUMAN OTC DRUG Intestinal Distress NOT APPLICABLE LIQUID ORAL 20140926 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALOE; ARSENIC TRIOXIDE; BOTULINUM TOXIN TYPE A; CAMPYLOBACTER JEJUNI; CITRULLUS COLOCYNTHIS FRUIT PULP; CLOSTRIDIUM DIFFICILE; COLCHICUM AUTUMNALE BULB; ECHINACEA ANGUSTIFOLIA; ESCHERICHIA COLI; HELICOBACTER PYLORI; MERCURIC CHLORIDE; QUININE SULFATE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SHIGELLA DYSENTERIAE; STRYCHNOS NUX-VOMICA SEED; VIBRIO CHOLERAE; YERSINIA ENTEROCOLITICA 6; 6; 30; 30; 6; 8; 4; 3; 30; 30; 6; 12; 33; 30; 6; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0487_ca64e67a-ec37-499e-a6e8-0bd8575fba7c 43742-0487 HUMAN OTC DRUG Healing Support Betula (Pendula), cortex), Caltha palustris, Galium aparine, Sedum acre, Thuja occidentalis, Urtica urens, Clematis erecta, Hedera helix, LIQUID ORAL 20140530 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIS MELLIFERA; BETULA PENDULA BARK; CALCIUM FLUORIDE; CALTHA PALUSTRIS; CLEMATIS RECTA FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; HEDERA HELIX FLOWERING TWIG; JUNIPER BERRY; NITRIC ACID; ONONIS SPINOSA WHOLE; PHOSPHORUS; QUILLAJA SAPONARIA BARK; RANCID BEEF; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; SILVER; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 12; 2; 8; 3; 4; 5; 3; 4; 4; 6; 5; 8; 4; 12; 3; 4; 8; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0488_dc799d72-f53c-4154-9fd4-266e6548e54e 43742-0488 HUMAN OTC DRUG Post-Dental Visit Chamomilla, Echinacea (Angustifolia), Hamamelis virginiana, Hypericum perforatum, Millefolium, Bryonia (Alba), Calendula officinalis, Arnica Montana, LIQUID ORAL 20140529 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACHILLEA MILLEFOLIUM; ACTIVATED CHARCOAL; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS VITALBA FLOWER; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HELIANTHEMUM NUMMULARIUM FLOWER; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF 3; 12; 4; 6; 6; 4; 8; 4; 8; 3; 3; 8; 3; 8; 3; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0489_2a2416d0-f9a8-4d80-92c6-dcaaa17f1aa6 43742-0489 HUMAN OTC DRUG Nerve Z Condurango, Echinacea (Angustifolia), Ginkgo biloba, Hydrastis canadensis, Myrrha, OSHA, Phytolacca decandra, Tabebuia impetiginosa, Propolis, LIQUID ORAL 20140702 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; GOLDENSEAL; LIGUSTICUM PORTERI ROOT; LYCOPODIUM CLAVATUM SPORE; MARSDENIA CONDURANGO BARK; MYRRH; PHYTOLACCA AMERICANA ROOT; PROPOLIS WAX; RANCID BEEF; SELENIUM; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; THYROID, PORCINE 3; 12; 3; 3; 3; 12; 3; 3; 3; 6; 30; 12; 12; 8; 8; 8; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0490_78adf65d-e8bf-4bc3-b6a6-4982e2188857 43742-0490 HUMAN OTC DRUG Liver Drainage Chelidonium majus, Carduus marianus, Schisandra chinensis, Taraxacum officinale, Berberis Vulgaris, Picrorhiza scrophulariiflora, Raphanus sativus, LIQUID ORAL 20140621 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; CHROMIUM GLUCONATE; CICHORIUM INTYBUS FLOWER; COBALTOUS GLUCONATE; COPPER GLUCONATE; LACTIC ACID, L-; MAGNESIUM GLUCONATE; MILK THISTLE; NEOPICRORHIZA SCROPHULARIIFLORA ROOT; PHENOL; PORK LIVER; PTELEA TRIFOLIATA BARK; RADISH; SCHISANDRA CHINENSIS FRUIT; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SULFUR IODIDE; SUS SCROFA GALLBLADDER; SUS SCROFA PANCREAS; TARAXACUM OFFICINALE; VANADIUM; VERBENA OFFICINALIS FLOWERING TOP; VISCUM ALBUM FRUITING TOP 3; 1; 6; 8; 6; 6; 6; 6; 2; 3; 8; 8; 6; 3; 2; 6; 8; 6; 8; 8; 2; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0491_12448610-b1ea-4377-9422-1c970c20d18d 43742-0491 HUMAN OTC DRUG Radiation Plus Chondrus crispus, Fucus vesiculosus, Thyroidinum (Suis), Cadmium iodatum, Cadmium sulphuratum, Iodium, Uranium nitricum, Radium bromatium, LIQUID ORAL 20140621 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALCOHOL, X-RAY EXPOSED (1000 RAD); ARNICA MONTANA; CADMIUM IODIDE; CADMIUM SULFIDE; CHONDRUS CRISPUS; FUCUS VESICULOSUS; IODINE; RADIUM BROMIDE; STRONTIUM CARBONATE; SUS SCROFA THYROID; URANYL NITRATE HEXAHYDRATE 30; 30; 12; 12; 3; 3; 12; 12; 12; 8; 12 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0492_469bd14d-90c8-40df-afbf-1daa92207107 43742-0492 HUMAN OTC DRUG Rheumatoid Arthritis Nosode ATP (Adenosine triphosphate disodium), Malic Acid, Natrum oxalaceticum, Oroticum acidum, Riboflavinum, Apiolum, Cinnamic acid, DHEA (Dehydroepiandrosterone), LIQUID ORAL 20140621 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; APIOLE (PARSLEY); BORRELIA BURGDORFERI; BRUCELLA ABORTUS; CAMPYLOBACTER JEJUNI; CHLAMYDIA TRACHOMATIS; CINNAMIC ACID; ENTEROCOCCUS FAECALIS; KLEBSIELLA PNEUMONIAE; MALIC ACID; MYCOPLASMA PNEUMONIAE; OROTIC ACID MONOHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PRASTERONE; PROTEUS MORGANII; RIBOFLAVIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE; SHIGELLA SONNEI; SODIUM DIETHYL OXALACETATE; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS EQUINUS; STREPTOCOCCUS MUTANS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS UBERIS; STREPTOCOCCUS VIRIDANS GROUP; YERSINIA ENTEROCOLITICA 6; 6; 15; 15; 15; 15; 6; 13; 15; 6; 15; 6; 15; 6; 30; 6; 14; 15; 15; 6; 9; 15; 32; 13; 17; 15; 12; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43742-0493_1c2c77ef-034c-40a8-88fe-5bc0ec33d9a4 43742-0493 HUMAN OTC DRUG Iron Mix Phenylalanine, Quercetin, Rutin, Ascorbic acid, Ferrum metallicum, Ferrum muriaticum, Ferrum phosphoricum, Ferrum sulphuricum, Sarcolacticum acidum, LIQUID ORAL 20140523 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ASCORBIC ACID; CORTICOTROPIN; ENTEROCOCCUS FAECALIS; FERRIC CHLORIDE HEXAHYDRATE; FERROSOFERRIC PHOSPHATE; FERROUS SULFATE; IRON; LACTIC ACID, L-; PHENYLALANINE; PROTEUS VULGARIS; QUERCETIN; RUTIN 4; 6; 30; 6; 6; 6; 6; 6; 6; 30; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43742-0494_7d577489-405b-42f1-a321-9ea4a039884e 43742-0494 HUMAN OTC DRUG Addiclenz not applicable LIQUID ORAL 20140722 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; ASPARTAME; ATROPA BELLADONNA; BENZALKONIUM CHLORIDE; BETA VULGARIS; COBALT; COPPER; FORMALDEHYDE; IODINE; LYCOPODIUM CLAVATUM SPORE; METHYLENE CHLORIDE; METHYLPARABEN; PETROSELINUM CRISPUM; PEUMUS BOLDUS LEAF; PHOSPHORIC ACID; PROPYLPARABEN; SELENIUM; SODIUM BENZOATE; SODIUM CITRATE; TARAXACUM OFFICINALE; TITANIUM DIOXIDE; ZINC; ZINC OXIDE 12; 30; 12; 30; 3; 12; 12; 30; 12; 12; 30; 30; 3; 3; 12; 30; 12; 30; 30; 3; 30; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0495_25dea277-b41b-407c-a046-a3a30c36a0be 43742-0495 HUMAN OTC DRUG Bacteria Plus NOT APPLICABLE LIQUID ORAL 20140717 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE PHOSPHATE DISODIUM; APIOLE (PARSLEY); CINNAMIC ACID; ECHINACEA ANGUSTIFOLIA; ENTEROCOCCUS FAECALIS; ESCHERICHIA COLI; HELICOBACTER PYLORI; LEGIONELLA PNEUMOPHILA; LISTERIA MONOCYTOGENES; MALIC ACID; MYCOPLASMA PNEUMONIAE; OROTIC ACID; PROTEUS MIRABILIS; PROTEUS MORGANII; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; RIBOFLAVIN; SHIGELLA DYSENTERIAE; SHIGELLA SONNEI; SODIUM DIETHYL OXALACETATE; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS EQUINUS; STREPTOCOCCUS MUTANS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS UBERIS; STREPTOCOCCUS VIRIDANS GROUP; YERSINIA ENTEROCOLITICA 6; 6; 6; 15; 13; 15; 15; 11; 14; 6; 15; 6; 15; 30; 15; 15; 6; 15; 15; 6; 9; 15; 32; 13; 15; 15; 12; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43742-0496_c3e27650-dba3-4160-8e97-0c0e5dfbe6d3 43742-0496 HUMAN OTC DRUG Enviroclenz not applicable LIQUID ORAL 20140722 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETONE; AMMONIUM CHLORIDE; ARCTIUM LAPPA ROOT; ATROPA BELLADONNA; BENZENE; BERBERIS VULGARIS ROOT BARK; CHLORINE; FRANGULA ALNUS BARK; GERMANIUM SESQUIOXIDE; GLYCYRRHIZA GLABRA; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; MENTHOL; MILK THISTLE; NITRIC ACID; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PROPYLENE GLYCOL; SANGUINARIA CANADENSIS ROOT; SODIUM BENZENESULFONATE; SODIUM LAURYL SULFATE; SODIUM TRIPOLYPHOSPHATE; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; TURPENTINE OIL 9; 9; 3; 12; 9; 3; 9; 3; 8; 3; 12; 12; 9; 3; 12; 12; 3; 9; 3; 9; 9; 9; 3; 12; 3; 3; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0497_fbf49bb3-e30e-459c-8f54-497aad065b92 43742-0497 HUMAN OTC DRUG Streptococcus Remedy not applicable LIQUID ORAL 20140731 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ENTEROCOCCUS FAECALIS; STREPTOCOCCUS MUTANS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS VIRIDANS GROUP 15; 15; 15; 15 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 43742-0498_a54f9a29-c8bd-4253-81bf-8b4b48f853eb 43742-0498 HUMAN OTC DRUG Enviroclenz Not applicable LIQUID ORAL 20140825 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETONE; AMMONIUM CHLORIDE; ARCTIUM LAPPA ROOT; ATROPA BELLADONNA; BENZENE; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; CHLORINE; FRANGULA ALNUS BARK; GERMANIUM SESQUIOXIDE; GLYCYRRHIZA GLABRA; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; METHYL ALCOHOL; MILK THISTLE; NITRIC ACID; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PROPYLENE GLYCOL; SODIUM BENZENESULFONATE; SODIUM LAURYL SULFATE; SODIUM TRIPOLYPHOSPHATE; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; TURPENTINE OIL 9; 9; 3; 12; 9; 3; 3; 9; 3; 8; 3; 12; 12; 9; 3; 12; 12; 3; 9; 9; 9; 9; 3; 12; 3; 3; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0499_8c09202e-68c7-4931-a2d4-06dac2cf2583 43742-0499 HUMAN OTC DRUG Female Stimulant NOT APPLICABLE LIQUID ORAL 20140902 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITIC ACID, (Z)-; ALCALIGENES FAECALIS; APIOLE (PARSLEY); APIS MELLIFERA VENOM; AQUILEGIA VULGARIS; CYPRIPEDIUM PARVIFOLUM ROOT; ESCHERICHIA COLI; ESTRADIOL; ESTRONE; GOLDENSEAL; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPERDON UTRIFORME FRUITING BODY; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS; PORK HEART; PROGESTERONE; SEPIA OFFICINALIS JUICE; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; SUS SCROFA UTERUS; TESTOSTERONE; WOOD CREOSOTE 10; 30; 6; 8; 4; 6; 30; 30; 8; 4; 10; 4; 6; 10; 10; 8; 30; 10; 8; 8; 12; 13; 6; 8; 8; 30; 8 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0500_33dff259-1d45-491a-9915-2b270886aa95 43742-0500 HUMAN OTC DRUG Chlamydia Remedy NOT APPLICABLE LIQUID ORAL 20140910 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHLAMYDIA TRACHOMATIS 12 [hp_X]/mL 43742-0511_4e61533a-2799-4544-b0fb-cf3eb5e62891 43742-0511 HUMAN OTC DRUG Metox NOT APPLICABLE LIQUID ORAL 20140911 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALUMINUM; ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; ASCORBIC ACID; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; CYSTEINE; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; FORMALDEHYDE; GADOLINIUM OXIDE; GARLIC; GERMANIUM SESQUIOXIDE; GLYCYRRHIZA GLABRA; GOLD; HOLMIUM; INDIUM; IRIDIUM; IRON; LANTHANUM OXIDE; LEAD; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; METHIONINE; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PHENOL; PHYTOLACCA AMERICANA ROOT; PLATINUM; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; SILVER; SODIUM CHLORIDE; STILLINGIA SYLVATICA ROOT; STRONTIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA THYROID; TANTALUM; TERBIUM; THALLIUM; TIN; TRIFOLIUM PRATENSE FLOWER; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC 12; 12; 3; 12; 6; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 6; 12; 12; 12; 12; 12; 3; 12; 3; 12; 12; 12; 8; 12; 12; 12; 12; 12; 12; 12; 12; 8; 12; 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 12; 8; 12; 12; 3; 12; 12; 8; 12; 12; 12; 12; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0512_8ae62110-8210-4c8c-8763-b88716a13f75 43742-0512 HUMAN OTC DRUG OSTEOREG NOT APPLICABLE LIQUID ORAL 20141118 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARANEUS DIADEMATUS; ASAFETIDA; BOS TAURUS PARATHYROID GLAND; CHOLECALCIFEROL; GOLD; HEKLA LAVA; HYDROCORTISONE; LYCOPODIUM CLAVATUM SPORE; MERCURIC OXIDE; POTASSIUM IODIDE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SODIUM SULFATE; STILLINGIA SYLVATICA ROOT; TRIBASIC CALCIUM PHOSPHATE 6; 4; 8; 6; 12; 8; 6; 30; 8; 4; 30; 4; 4; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0513_b4bcccdb-5c4d-481b-bc32-7553d5bfa87e 43742-0513 HUMAN OTC DRUG EBOLA REMEDY NOT APPLICABLE LIQUID ORAL 20140926 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CROTALUS HORRIDUS HORRIDUS VENOM 8 [hp_X]/mL 43742-0514_7a558ae1-2e15-4196-9684-46a0a11d0779 43742-0514 HUMAN OTC DRUG Mineral Balancing and Energy NOT APPLICABLE LIQUID ORAL 20141007 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE CYCLIC PHOSPHATE; ALUMINUM; ALUMINUM OXIDE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CEROUS OXALATE NONAHYDRATE; CESIUM CHLORIDE; CHOLECALCIFEROL; CHROMIUM; COBALT; COBALTOUS GLUCONATE; COPPER; CUPRIC SULFATE; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; FERROUS FUMARATE; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; INDIUM; IRON; LANTHANUM OXIDE; LEAD; LITHIUM CARBONATE; MAGNESIUM; MAGNESIUM ASPARTATE; MANGANESE; MANGANESE GLUCONATE; MERCURIC CHLORIDE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NICKEL ACETATE; NIOBIUM; OSMIUM; PALLADIUM; PHOSPHORUS; PLATINUM; POTASSIUM ASPARTATE; PRASEODYMIUM; PROTEUS MORGANII; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; SILVER; SODIUM MOLYBDATE; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; TIN; URANYL NITRATE HEXAHYDRATE; VANADIUM; VISCUM ALBUM FRUITING TOP; YTTERBIUM OXIDE; ZINC 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 8; 12; 8; 12; 12; 6; 12; 6; 12; 12; 12; 6; 12; 12; 12; 12; 12; 12; 12; 200; 12; 12; 6; 12; 6; 30; 12; 12; 12; 12; 8; 12; 12; 12; 6; 12; 6; 12; 30; 12; 12; 12; 12; 12; 6; 12; 12; 12; 12; 12; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0515_a823e4ff-8de8-4578-ae0f-b24b59197e84 43742-0515 HUMAN OTC DRUG ADDICLENZ NOT APPLICABLE LIQUID ORAL 20140929 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; ASPARTAME; ATROPA BELLADONNA; BENZALKONIUM CHLORIDE; BETA VULGARIS; CHELIDONIUM MAJUS; COBALT; COPPER; FORMALDEHYDE; IODINE; LYCOPODIUM COMPLANATUM SPORE; METHYLENE CHLORIDE; METHYLPARABEN; PETROSELINUM CRISPUM; PEUMUS BOLDUS LEAF; PHOSPHORIC ACID; PROPYLPARABEN; SELENIUM; SODIUM BENZOATE; SODIUM CITRATE; TARAXACUM OFFICINALE; TITANIUM DIOXIDE; ZINC; ZINC OXIDE 12; 30; 12; 30; 3; 3; 12; 12; 30; 12; 12; 30; 30; 3; 3; 12; 30; 12; 30; 30; 3; 30; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0543_236b1d50-59de-47a1-8ae6-d6d5748addd2 43742-0543 HUMAN OTC DRUG MALE STIMULANT ARALIA QUINQUEFOLIA, AGNUS CASTUS, ASCORBIC ACID, CALADIUM SEGUINUM, KALI BROMATUM, STYRCHNINUM PHOSPHORICUM, CANTHARIS, DAMIANA LIQUID ORAL 20141202 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMERICAN GINSENG; ASCORBIC ACID; CHASTE TREE; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; DIEFFENBACHIA SEGUINE; FERROSOFERRIC PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE PHOSPHATE, DIBASIC; PORK HEART; POTASSIUM BROMIDE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SELENIUM; STRYCHNINE PHOSPHATE DIHYDRATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; SUS SCROFA TESTICLE; SUS SCROFA UMBILICAL CORD; TESTOSTERONE; TURNERA DIFFUSA LEAFY TWIG; ZINC 4; 6; 6; 8; 13; 6; 10; 28; 8; 10; 20; 8; 6; 30; 10; 6; 8; 8; 12; 8; 8; 8; 8; 30; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43742-0545_8dfefffc-4ccf-409a-953d-9f9d9d774212 43742-0545 HUMAN OTC DRUG GIARDIA LAMBLIA REMEDY NOT APPLICABLE LIQUID ORAL 20141111 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc GIARDIA LAMBLIA 11 [hp_C]/mL 43742-0557_418c6681-e48f-499f-9e29-c58c82b21a6c 43742-0557 HUMAN OTC DRUG ENERGY CATALYST VISCUM ALBUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERROUS FUMARATE, MAGNESIUM ASPARTATE, MANGANESE GLUCONATE, PHOSPHORUS LIQUID ORAL 20141210 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE CYCLIC PHOSPHATE; ALUMINUM; ALUMINUM OXIDE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CEROUS OXALATE NONAHYDRATE; CESIUM CHLORIDE; CHOLECALCIFEROL; CHROMIUM; COBALT; COBALTOUS GLUCONATE; COPPER; CUPRIC SULFATE; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; FERROUS FUMARATE; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; INDIUM; IRON; LANTHANUM OXIDE; LEAD; LITHIUM CARBONATE; MAGNESIUM; MAGNESIUM ASPARTATE; MANGANESE; MANGANESE GLUCONATE; MERCURIC CHLORIDE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NICKEL ACETATE; NIOBIUM; OSMIUM; PALLADIUM; PHOSPHORUS; PLATINUM; POTASSIUM ASPARTATE; PRASEODYMIUM; PROTEUS MORGANII; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; SILVER; SODIUM MOLYBDATE; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; TIN; URANYL NITRATE HEXAHYDRATE; VANADIUM; VISCUM ALBUM FRUITING TOP; YTTERBIUM OXIDE; ZINC 8; 12; 30; 12; 12; 12; 12; 12; 12; 12; 12; 12; 8; 12; 8; 12; 12; 6; 12; 6; 12; 12; 12; 6; 12; 12; 12; 12; 12; 12; 12; 200; 12; 12; 6; 12; 6; 30; 12; 12; 12; 12; 8; 12; 12; 12; 6; 12; 6; 12; 30; 12; 12; 12; 12; 12; 6; 12; 12; 12; 12; 12; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43749-110_b3cd4086-e92f-45f9-a918-1e160922ad5f 43749-110 HUMAN OTC DRUG Avedana Medicated Chest Rub Camphor Eucalyptus Menthol OINTMENT TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part348 Unipack, Inc. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 g/100g; g/100g; g/100g 43749-230_b30f8b41-593a-425f-ab65-1345fbe17576 43749-230 HUMAN OTC DRUG Natures Choice Vitamins A and D A and D Ointment OINTMENT TOPICAL 20140918 OTC MONOGRAPH FINAL part347 Unipack, Inc. PETROLATUM 99.397 g/100g 43749-230_da1c3876-8a76-4864-8c92-8ed99edbabcb 43749-230 HUMAN OTC DRUG Natures Choice Vitamins A and D A and D Ointment OINTMENT TOPICAL 20140918 OTC MONOGRAPH FINAL part347 Unipack, Inc. PETROLATUM 99.397 g/100g 43749-310_68cc6306-2b0f-4f9e-8b8a-038265817d2f 43749-310 HUMAN OTC DRUG Avedana Pain Relieving Roll On Menthol GEL TOPICAL 20140929 OTC MONOGRAPH NOT FINAL part348 Unipack, Inc. CAMPHOR (SYNTHETIC); MENTHOL .4; 3.5 g/100g; g/100g 43749-320_7b240653-d20c-4ea0-bbb0-6dbb4d41c574 43749-320 HUMAN OTC DRUG Natures Choice Cool Hot Ice Menthol GEL TOPICAL 20140918 OTC MONOGRAPH NOT FINAL part348 Unipack, Inc. MENTHOL 2 g/100g 43749-430_db281e08-59bb-4463-a1e9-fd40d0294f4e 43749-430 HUMAN OTC DRUG Avedana Hemorrhoidal Hemorrhoidal Rectal Suppositories SUPPOSITORY RECTAL 20140918 OTC MONOGRAPH FINAL part346 Unipack, Inc. COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 88.5; .26 g/100g; g/100g 43749-440_717beeab-32fa-4ee9-9119-693a6765a0a8 43749-440 HUMAN OTC DRUG Avedana Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20140918 OTC MONOGRAPH NOT FINAL part334 Unipack, Inc. GLYCERIN 83 g/100g 43749-510_8c0dd635-9e05-43d5-8360-90dca82df70c 43749-510 HUMAN OTC DRUG Avedana Pain-Relieving Menthol SPRAY TOPICAL 20140929 OTC MONOGRAPH NOT FINAL part348 Unipack, Inc. MENTHOL 9 g/100g 43772-0001_9e649bda-788b-40ee-a64f-a38a48d535aa 43772-0001 HUMAN OTC DRUG Stomach Tincture Gentiana Lutea, Sambucus Nigra, Senna, Stomach (bovine), Arsenicum Album, Atropinum Sulphuricum, Carbo Vegetabilis LIQUID ORAL 20120822 UNAPPROVED HOMEOPATHIC Synergy Formulas ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; ATROPINE SULFATE; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP; SENNA LEAF; STRYCHNOS NUX-VOMICA SEED; TRIPE 12; 12; 12; 3; 12; 12; 3; 3; 12; 6 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL 43772-0002_29deabc1-ff4b-4b66-a675-65a6c198373b 43772-0002 HUMAN OTC DRUG Neurosode Glandula Suprarenalis Suis, Brain (suis), Kidney (suis), Ubiquinone, Agaricus Muscarius, Coccus Cacti, Conium Maculatum, Phosphorus LIQUID ORAL 20120822 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc ACETIC ACID; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ASPARTAME; BENZALKONIUM CHLORIDE; BENZOIC ACID; BENZYL ALCOHOL; BORIC ACID; CHLORINE; CITHARACANTHUS SPINICRUS; CONIUM MACULATUM FLOWERING TOP; CORTICOTROPIN; CORTISONE ACETATE; ESTRONE; EUGENOL; FORMALDEHYDE; GELSEMIUM SEMPERVIRENS ROOT; HEPATITIS B VIRUS; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4; HUMAN HERPESVIRUS 3; HUMAN HERPESVIRUS 4; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LATRODECTUS MACTANS; LEAD; MEASLES VIRUS; METHYLENE CHLORIDE; METHYLENE CHLORIDE; METHYLPARABEN; NAJA NAJA VENOM; PETROLATUM; PHENYLBUTAZONE; PHOSPHORUS; POLIOVIRUS; PORK BRAIN; PORK KIDNEY; POTASSIUM SORBATE; PROPYLPARABEN; PROTORTONIA CACTI; RESORCINOL; SALICYLIC ACID; SODIUM BENZOATE; SODIUM CITRATE; SORBITOL; STEARYL ALCOHOL; SUS SCROFA ADRENAL GLAND; TITANIUM DIOXIDE; TOXICODENDRON PUBESCENS LEAF; UBIDECARENONE; XYLITOL; ZINC OXIDE 30; 12; 30; 30; 30; 30; 30; 30; 30; 12; 30; 30; 30; 30; 30; 30; 30; 15; 15; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 15; 30; 30; 12; 30; 8; 8; 30; 30; 12; 30; 30; 30; 30; 30; 30; 8; 30; 12; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0003_968f65a8-2db0-4a75-afe7-b8282541836b 43772-0003 HUMAN OTC DRUG Bacsode Hydrastis Canadensis, Myrrha, Tabebuia Impetiginosa, Belladonna, Thymus, Glandula Suprarenalis Bovinum, Spleen LIQUID ORAL 20130329 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ATROPA BELLADONNA WHOLE; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; BOTULINUM TOXIN TYPE A; CHLAMYDIA TRACHOMATIS; CLOSTRIDIUM TETANI; CROTALUS HORRIDUS HORRIDUS VENOM; ESCHERICHIA COLI; GOLDENSEAL; HYPERICUM PERFORATUM; LOMATIUM DISSECTUM ROOT; MYRRH; NEISSERIA MENINGITIDIS; PASTEURELLA MULTOCIDA; PHOSPHORUS; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS PNEUMONIAE; TABEBUIA IMPETIGINOSA BARK 6; 8; 8; 8; 18; 18; 18; 12; 18; 3; 12; 12; 3; 18; 18; 12; 18; 18; 18; 33; 18; 18; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0004_5b5ec7ae-8397-4f27-9b69-5451902f1116 43772-0004 HUMAN OTC DRUG Adrenal Tincture Chelidonium Majus, Echinacea, Glandula Suprarenalis Bovinum, Spleen, Carduus Marianus, Natrum Muriaticum LIQUID ORAL 20130401 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; PHOSPHORIC ACID; SILYBUM MARIANUM SEED; SODIUM CHLORIDE 8; 8; 3; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0005_6250d719-24ae-48a0-a88f-247ce93767c7 43772-0005 HUMAN OTC DRUG Oligo Iodine Chelidonium Majus, Spongia Tosta, Iodium, Fucus Vesiculosus, Germanium Sesquioxide, Thyroidinum, Calcarea Carbonica LIQUID ORAL 20130401 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. .ALPHA.-KETOGLUTARIC ACID; BOS TAURUS PITUITARY GLAND; BROMINE; CALCIUM IODIDE; CHELIDONIUM MAJUS; COPPER; CYSTEINE; EUGENOL; FERROUS IODIDE; FORMALDEHYDE; FUCUS VESICULOSUS; FUMARIC ACID; GERMANIUM SESQUIOXIDE; GOLD; HUMAN COXSACKIEVIRUS B1; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; IODINE; LIDOCAINE; MANGANESE GLUCONATE; MERCURIUS SOLUBILIS; MOLYBDENUM; NICKEL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PALLADIUM; POTASSIUM IODIDE; PULSATILLA VULGARIS; RANCID BEEF; SILVER; SODIUM DIETHYL OXALACETATE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID; TIN; TITANIUM; VANADIUM; ZINC 12; 12; 30; 30; 3; 12; 12; 12; 12; 12; 6; 12; 8; 12; 8; 30; 4; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 3; 8; 12; 12; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0006_f8b061be-7ba8-470e-8b24-1d68cd669d2d 43772-0006 HUMAN OTC DRUG Krebs Stimulator Plus Tabebuia Impetiginosa, Uncaria Tomentosa, Hypothalamus, Pituitaria Glandula, Glandula Suprarenalis Suis, Nadidum LIQUID ORAL 20130401 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ADENOSINE TRIPHOSPHATE; CAT'S CLAW; COENZYME A; GERMANIUM SESQUIOXIDE; LACTIC ACID, DL-; LACTIC ACID, L-; NADIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; TABEBUIA IMPETIGINOSA BARK; UBIDECARENONE 8; 3; 6; 8; 6; 6; 6; 6; 6; 6; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0007_a6bdcc64-44a0-4d0f-a244-bfa178842426 43772-0007 HUMAN OTC DRUG Virosode Cinchona Officinalis, Hydrastis Canadensis, Lomatium Dissectum, Nasturtium Aquaticum, Nux Moschata, Tabebuia Impetiginosa LIQUID ORAL 20121204 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc ATROPA BELLADONNA WHOLE; BOS TAURUS ADRENAL GLAND; CAT'S CLAW; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; GERMANIUM SESQUIOXIDE; GOLDENSEAL; HEPATITIS B VIRUS; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4; HUMAN HERPESVIRUS 3; HUMAN HERPESVIRUS 4; LACHESIS MUTA VENOM; LOMATIUM DISSECTUM ROOT; MEASLES VIRUS; MYRRH; NASTURTIUM OFFICINALE; NUTMEG; POLIOVIRUS; RANCID BEEF; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK 12; 8; 3; 3; 6; 8; 3; 33; 15; 15; 30; 30; 8; 3; 30; 3; 3; 3; 30; 30; 12; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0008_ba3f3987-f86e-4311-8a04-1622e36fcb93 43772-0008 HUMAN OTC DRUG Viral Plus Arsenicum Album, Belladonna, Echinacea, Eupatorium Perfoliatum, Gelsemium Sempervirens, Lycopodium Clavatum LIQUID ORAL 20130402 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0009_fea9836b-7889-4aae-bd60-4b47330d771f 43772-0009 HUMAN OTC DRUG Calcium Composition Arnica Montana, Echinacea, Boron Gluconate, Symphytum Officinale, Hekla Lava, Calcarea Carbonica LIQUID ORAL 20130402 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ARNICA MONTANA; BORON GLUCONATE; CALCIUM FLUORIDE; COMFREY ROOT; ECHINACEA, UNSPECIFIED; HEKLA LAVA; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE 3; 6; 12; 6; 3; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0010_323c98ee-77b5-4706-a8e1-2d3646110c58 43772-0010 HUMAN OTC DRUG Colloidal Silver Colloidal Silver LIQUID ORAL 20130402 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. SILVER 6 [hp_X]/mL 43772-0011_2f970ef0-e728-4f2d-b74a-e8b357af69ac 43772-0011 HUMAN OTC DRUG Cerebral Composition Cholinum, Capsicum Annuum, Ginkgo Biloba, Arnica Montana, Gelsemium Sempervirens, Kali Phosphoricum LIQUID ORAL 20130402 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ARNICA MONTANA; BARIUM CARBONATE; CAPSICUM; CHOLINE HYDROXIDE; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; SEMECARPUS ANACARDIUM JUICE; SEROTONIN 3; 8; 3; 2; 3; 3; 6; 3; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0012_ad6fb804-820b-4a82-b6dc-b8650c49c48e 43772-0012 HUMAN OTC DRUG Allergy Composition Chondrus Crispus, Glycyrrhiza Glabra, Zingiber Officinale, Ambrosia Artemisiaefolia, Histaminum Hydrochloricum, L Dopa LIQUID ORAL 20130417 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. AMBROSIA ARTEMISIIFOLIA; CHONDRUS CRISPUS; ETILEVODOPA; GINGER; GLYCYRRHIZA GLABRA; HISTAMINE DIHYDROCHLORIDE; IODINE; SCHOENOCAULON OFFICINALE SEED; SODIUM CARBONATE; TAURINE 3; 3; 6; 3; 3; 4; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0013_4ec9d4c2-3249-407d-9c0b-06305c24fe89 43772-0013 HUMAN OTC DRUG Hypothalamus Tincture Aralia Quinquefolia, Hydrocotyle Asiatica, Polygonum Multiflorum, Hypothalamus, Pituitary, Germanium Sesquioxide LIQUID ORAL 20130418 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. AMERICAN GINSENG; CENTELLA ASIATICA; FALLOPIA MULTIFLORA ROOT; GERMANIUM SESQUIOXIDE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND 3; 3; 3; 12; 8; 14; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0014_bea16e48-e4c4-455f-9f3d-fa9dcfa2f3a6 43772-0014 HUMAN OTC DRUG ALLERSODE II Allium Cepa, Ambrosia Artemisiaefolia, Euphrasia Officinalis, Sabadilla, Sheep Sorrel, Yellow Dock, Kentucky Bluegrass, Orchard, Redtop, Timothy LIQUID ORAL 20130807 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ACER NEGUNDO POLLEN; AGROSTIS GIGANTEA POLLEN; ALFALFA; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ARSENIC TRIOXIDE; BETULA OCCIDENTALIS POLLEN; CARYA OVATA POLLEN; DACTYLIS GLOMERATA TOP; EUPHRASIA STRICTA; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; HISTAMINE DIHYDROCHLORIDE; JUGLANS NIGRA POLLEN; ONION; PHLEUM PRATENSE TOP; PHOSPHORUS; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS TOP; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; PORK LIVER; PULSATILLA VULGARIS; QUERCUS RUBRA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS TOP; SALIX NIGRA POLLEN; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; SUS SCROFA ADRENAL GLAND; TRIFOLIUM PRATENSE FLOWER; ULMUS AMERICANA POLLEN 6; 6; 6; 6; 3; 6; 6; 12; 6; 6; 6; 3; 6; 6; 6; 6; 3; 6; 12; 6; 6; 6; 6; 12; 6; 6; 6; 6; 6; 6; 12; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0015_ea2db6e4-bc52-4a3a-91cb-91b8fceb4b53 43772-0015 HUMAN OTC DRUG Amoebasode Triticum Aestivum, Cajuputum, Baptisia Tinctoria, Capsicum Annuum, Fragaria Vesca, Frasera Caroliniensis, Quassia Amara, Senna LIQUID ORAL 20130813 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ALPINE STRAWBERRY; AMOEBA PROTEUS; BAPTISIA TINCTORIA; BEEF LIVER; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; CAJUPUT OIL; CAPSICUM; CINCHONA OFFICINALIS BARK; FRASERA CAROLINIENSIS ROOT; GIARDIA LAMBLIA; LYCOPODIUM CLAVATUM SPORE; QUASSIA AMARA WOOD; SENNA LEAF; TRITICUM AESTIVUM WHOLE; WORMWOOD 3; 8; 3; 8; 8; 8; 1; 3; 12; 3; 9; 12; 3; 3; 1; 6 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0016_3d08a10b-272c-4808-b0bf-8d153eefd899 43772-0016 HUMAN OTC DRUG FNGSODE Ceanothus Americanus, Condurango, Echinacea, Hydrastis Canadensis, Ligusticum Porteri, Lomatium Dissectum, Nasturtium Aquaticum LIQUID ORAL 20130812 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ASTRAGALUS PROPINQUUS ROOT; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CANDIDA ALBICANS; CEANOTHUS AMERICANUS LEAF; ECHINACEA, UNSPECIFIED; GOLDENSEAL; LIGUSTICUM PORTERI ROOT; LOMATIUM DISSECTUM ROOT; MARSDENIA CONDURANGO BARK; NASTURTIUM OFFICINALE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PORK KIDNEY; PROPOLIS WAX; SEPIA OFFICINALIS JUICE; SODIUM BORATE; TABEBUIA IMPETIGINOSA BARK 6; 8; 8; 8; 12; 1; 3; 3; 3; 3; 3; 3; 12; 12; 8; 6; 12; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0017_878e6165-29db-4ff2-a041-c7dbfb342273 43772-0017 HUMAN OTC DRUG Bronchi Plus not applicable LIQUID ORAL 20140825 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ACTIVATED CHARCOAL; COPPER; DROSERA ROTUNDIFOLIA; IPECAC; LACHESIS MUTA VENOM; LOBELIA INFLATA; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0018_0cd11851-8428-45e4-8a32-a26b8f67596a 43772-0018 HUMAN PRESCRIPTION DRUG DepressionComposition Cholinum, Inositol, Lithium Carbonicum, Pulsatilla, Ignatia Amara, GABA, Pituitaria Glandula (Suis), Pineal (Suis), Dopamine, Serotonin LIQUID ORAL 20130822 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. .GAMMA.-AMINOBUTYRIC ACID; CHOLINE HYDROXIDE; DOPAMINE; GOLD; INOSITOL; LITHIUM CARBONATE; PETROSELINUM CRISPUM; PULSATILLA VULGARIS; SEROTONIN; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; SULFUR; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND 4; 3; 12; 12; 3; 3; 60; 3; 12; 12; 3; 60; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Mood Stabilizer [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 43772-0020_961692f4-f0d7-4095-b49f-87dc00dfa924 43772-0020 HUMAN OTC DRUG Bacsode Hydrastis Canadensis, Tabebuia Impetiginosa, Belladonna, Thymus (Bovine), Thymus (Bovine), Glandula Suprarenalis Bovine, Spleen (Bovine) LIQUID ORAL 20130827 UNAPPROVED HOMEOPATHIC Synergy Formulas ATROPA BELLADONNA; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; BOTULINUM TOXIN TYPE A; CHLAMYDIA TRACHOMATIS; CLOSTRIDIUM TETANI; CROTALUS HORRIDUS HORRIDUS VENOM; ESCHERICHIA COLI; GOLDENSEAL; HYPERICUM PERFORATUM; LOMATIUM DISSECTUM ROOT; MYRRH; NEISSERIA MENINGITIDIS; PASTEURELLA MULTOCIDA; PHOSPHORUS; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS PNEUMONIAE; TABEBUIA IMPETIGINOSA BARK 6; 8; 8; 8; 18; 18; 18; 12; 18; 3; 12; 12; 3; 18; 18; 12; 18; 18; 33; 18; 18; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0021_8a825f9d-8892-45bb-b404-8537ccb0bbae 43772-0021 HUMAN OTC DRUG Lymesode Chelidonium majus, Echinacea (Angustifolia), Hydrastis canadensis, Nasturtium aquaticum, Taraxacum officinale, Trifolium pratense, Rhus toxicodendron, Arnica montana, LIQUID ORAL 20140623 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ARNICA MONTANA; BORRELIA BURGDORFERI; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HEPATITIS B VIRUS; JAPANESE ENCEPHALITIS VIRUS; LATRODECTUS MACTANS; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; NASTURTIUM AQUATICUM; NEISSERIA MENINGITIDIS; OXALIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA THYMUS; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER 6; 12; 3; 3; 3; 30; 12; 8; 8; 3; 15; 6; 6; 6; 6; 3; 5; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0023_e3172295-efd9-4015-942f-b9f3d5c62002 43772-0023 HUMAN OTC DRUG Rescue 30C-200C Clematis Vitalba, Helianthemum Nummularium, Impatiens Glandulifera, Ornithogalum Umbellatum, Prunus Cerasifera LIQUID ORAL 20140110 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43772-0024_0837f6b5-7c5b-448c-be24-aaf6ebbb5ea3 43772-0024 HUMAN OTC DRUG Drainage Composition Shark Cartilage, Scrophularia Nodosa, Echinacea, Phytolacca Decandra, Germanium Sesquioxide, Calcarea Iodata, Lymph, Spleen, Thuja Occidentalis, LIQUID ORAL 20140110 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. CALCIUM IODIDE; CAPSICUM; ECHINACEA, UNSPECIFIED; GERMANIUM SESQUIOXIDE; NITRIC ACID; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SHARK CARTILAGE; SULFUR IODIDE; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; THUJA OCCIDENTALIS LEAF 3; 6; 2; 12; 12; 3; 1; 6; 12; 6; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0027_ef51844a-15ef-4cd0-a6ae-063249da4e29 43772-0027 HUMAN OTC DRUG Krebs Stimulator Plus Tabebuia impetiginosa, Uncaria tomentosa, Hypothalamus (Suis), Pituitaria glandula (Suis), Glandula suprarenalis suis, Nadidum, Lacticum acidum, Sarcolacticum acidum, LIQUID ORAL 20140623 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; CAT'S CLAW; COENZYME A; GERMANIUM SESQUIOXIDE; LACTIC ACID, L-; NADIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; TABEBUIA IMPETIGINOSA BARK; UBIDECARENONE 8; 3; 6; 8; 6; 6; 6; 6; 6; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0030_7be650af-c8d8-4d05-a6e6-144e84f01a5e 43772-0030 HUMAN OTC DRUG Nerve Plus Composition Agaricus Muscarius, Symphytum Officinale, Hypericum Perforatum, Arnica Montana LIQUID ORAL 20140311 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. AMANITA MUSCARIA FRUITING BODY; ARNICA MONTANA; ARSENIC TRIOXIDE; COMFREY ROOT; EGG PHOSPHOLIPIDS; HYPERICUM PERFORATUM; LEAD; NAJA NAJA VENOM; PHOSPHORUS; PORK BRAIN 3; 3; 30; 3; 8; 3; 8; 12; 4; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0032_05de1caa-fff4-4d32-9739-fc240901a41f 43772-0032 HUMAN OTC DRUG Ear Inflammation Plus Belladonna, Conium maculatum, Dulcamara, Hepar sulphuris calcareum, Kali bichromicum, Mercurius solubilis, Pulsatilla (Vulgaris), LIQUID ORAL 20140513 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ATROPA BELLADONNA; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SOLANUM DULCAMARA TOP 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0033_44504ad3-22c5-45ad-a033-3161c0eb6134 43772-0033 HUMAN OTC DRUG Liver Tonic 3 Boldo, Carduus marianus, Taraxacum officinale, Ceanothus americanus, Quassia (amara), Raphanus sativus, Phosphorus, Cholesterinum, Benzinum, LIQUID ORAL 20140520 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; ARSENIC TRIOXIDE; BENZENE; CEANOTHUS AMERICANUS LEAF; CHOLESTEROL; ESCHERICHIA COLI; GERMANIUM SESQUIOXIDE; MANGANESE; MILK THISTLE; PEUMUS BOLDUS LEAF; PHOSPHORUS; QUASSIA AMARA WOOD; RADISH; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; TARAXACUM OFFICINALE; VERONICASTRUM VIRGINICUM ROOT 8; 6; 6; 2; 6; 12; 8; 8; 1; 1; 4; 3; 3; 30; 1; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0034_0d832a90-0cf0-439f-9871-d10adfb700f5 43772-0034 HUMAN OTC DRUG Drainage Composition Scrophularia nodosa, Echinacea (Angustifolia), Phytolacca decandra, Calcarea iodate, Thuja occidentalis, Capsicum annuum, Shark cartilage, LIQUID ORAL 20140602 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. CALCIUM IODIDE; CAPSICUM; ECHINACEA ANGUSTIFOLIA; GERMANIUM SESQUIOXIDE; NITRIC ACID; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SHARK CARTILAGE; SULFUR IODIDE; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; THUJA OCCIDENTALIS LEAFY TWIG 3; 6; 2; 12; 12; 3; 1; 6; 12; 6; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0035_369ac386-1ac5-457e-8834-33f30d088443 43772-0035 HUMAN OTC DRUG ADRENAL TINCTURE Chelidonium Majus, Echinacea(Angustifolia), Glandula Suprarenalis Bovine, Spleen(bovine), Carduus Marianus, Natrum Muriaticum, Phosporicum Acidum LIQUID ORAL 20140707 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; MILK THISTLE; PHOSPHORIC ACID; SODIUM CHLORIDE 8; 8; 3; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0036_71376217-7ef1-4312-a81b-0c612cad4661 43772-0036 HUMAN OTC DRUG Cerebral Composition Cholinum, Capsicum Annuum, Ginkgo Biloba, Arnica Montana, Gelsemium Sempervirens, Kali Phosphoricum, Anacardium Orientale, Phosphorus, Serotonin (Hydrochloride, Baryta Carbonica LIQUID ORAL 20140716 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ANACARDIUM OCCIDENTALE FRUIT; ARNICA MONTANA; BARIUM CARBONATE; CAPSICUM; CHOLINE HYDROXIDE; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; SEROTONIN HYDROCHLORIDE 6; 3; 8; 3; 2; 3; 3; 6; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0037_1714ac26-b447-45a7-a43d-b24f789f3963 43772-0037 HUMAN OTC DRUG Calcium Composition Arnica Montana, Echinacea (Angustifolia), Boron Glucconate, Symphytum Officinale, Hekla Lava, Calcarea Carbonica, Clacarea Fluorica, Calcarea phosphorica, Lycopodium Clavatum, Silicea. LIQUID ORAL 20140716 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc ARNICA MONTANA; BORON GLUCONATE; CALCIUM FLUORIDE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; HEKLA LAVA; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE 3; 6; 12; 6; 3; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0039_1c7bf590-c837-47ff-a727-a9eab7e0c54a 43772-0039 HUMAN OTC DRUG Adrenal Tincture not applicable LIQUID ORAL 20140718 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; ECHINACEA ANGUSTIFOLIA; EPINEPHRINE; MILK THISTLE; PHOSPHORIC ACID; SODIUM CHLORIDE 8; 8; 3; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0040_482521c8-da2b-4a0d-ab91-65301d9bca6c 43772-0040 HUMAN OTC DRUG Viral Plus not applicable LIQUID ORAL 20140717 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL 43772-0041_30ad7cb1-7a50-45db-83c3-3d7fbf35b736 43772-0041 HUMAN OTC DRUG Oligo Iodine NOT APPLICABLE LIQUID ORAL 20140716 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. .ALPHA.-KETOGLUTARIC ACID; BOS TAURUS PITUITARY GLAND; BROMINE; CALCIUM IODIDE; CLOVE; COPPER; CYSTEINE; FERROUS IODIDE; FORMALDEHYDE; FUCUS VESICULOSUS; FUMARIC ACID; GERMANIUM SESQUIOXIDE; GOLD; HUMAN COXSACKIEVIRUS B1; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; IODINE; LIDOCAINE; MANGANESE GLUCONATE; MERCURIUS SOLUBILIS; MOLYBDENUM; NICKEL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PALLADIUM; POTASSIUM IODIDE; PULSATILLA VULGARIS; RANCID BEEF; SILVER; SODIUM DIETHYL OXALACETATE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID; TIN; TITANIUM; VANADIUM; ZINC 12; 12; 30; 30; 12; 12; 12; 12; 12; 6; 12; 8; 12; 8; 30; 4; 12; 12; 12; 12; 12; 12; 12; 12; 12; 14; 12; 12; 3; 8; 12; 12; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0042_8cebcb38-c604-42b0-b905-8ac9142c05d5 43772-0042 HUMAN OTC DRUG HYPERT PLUS NOT APPLICABLE LIQUID ORAL 20140925 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ARNICA MONTANA; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SELENICEREUS GRANDIFLORUS STEM; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0043_413decba-aced-48bf-9a1e-c4ab644d1c47 43772-0043 HUMAN OTC DRUG DEPRESSION COMPOSITION NOT APPLICABLE LIQUID ORAL 20140926 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. .GAMMA.-AMINOBUTYRIC ACID; CHOLINE HYDROXIDE; DOPAMINE HYDROCHLORIDE; GOLD; INOSITOL; LITHIUM CARBONATE; PETROSELINUM CRISPUM; PULSATILLA VULGARIS; SEROTONIN HYDROCHLORIDE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; SULFUR; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND 4; 3; 12; 12; 3; 3; 60; 3; 12; 12; 3; 60; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43772-0044_149cd648-cafd-44f7-9277-d7f26b77969d 43772-0044 HUMAN OTC DRUG CALMING COMPOSITION NOT APPLICABLE LIQUID ORAL 20141117 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ACONITUM NAPELLUS; AVENA SATIVA FLOWERING TOP; FERULA COMMUNIS SUBSP. GLAUCA; FERULA SUMBUL ROOT; HOPS; MELILOTUS OFFICINALIS TOP; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; STRYCHNOS IGNATII SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; VALERIAN; ZINC 30; 1; 6; 3; 1; 3; 8; 3; 6; 30; 2; 6; 8; 8; 1; 8 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43773-1001_28c87785-4554-4172-9b11-f6a9d72923a8 43773-1001 HUMAN PRESCRIPTION DRUG Testopel TESTOSTERONE PELLET SUBCUTANEOUS 20090721 ANDA ANDA080911 Slate Pharma TESTOSTERONE 75 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 43825-102_65d68de0-3b27-11e3-aa6e-0800200c9a66 43825-102 HUMAN PRESCRIPTION DRUG Ofirmev acetaminophen INJECTION, SOLUTION INTRAVENOUS 20101108 NDA NDA022450 Cadence Pharmaceuticals, Inc. ACETAMINOPHEN 10 mg/mL 43846-0001_b848edd6-5e81-4c78-898b-fd4aa0622436 43846-0001 HUMAN PRESCRIPTION DRUG Tendon Rescue Bryonia, Ruta graveolens, Bellis perennis, Argentum metallicum GEL TOPICAL 20130321 UNAPPROVED HOMEOPATHIC Peaceful Mountain BELLIS PERENNIS; BRYONIA ALBA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILVER 6; 3; 3; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0002_b285bfd2-56b7-44fa-a989-7c172119e0c2 43846-0002 HUMAN OTC DRUG Muscle Ice Phytolacca decandra, Symphytum officinale, Bellis perennis, Ledum palustre, Ruta graveolens, Magnesia phosphorica, Silicea, GEL TOPICAL 20120525 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. BELLIS PERENNIS; COMFREY ROOT; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE 6; 3; 6; 9; 1; 6; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0003_5f9f7029-5fc3-4948-8b06-5c81b57eb046 43846-0003 HUMAN OTC DRUG Back and Neck Rescue Hypericum Perforatum, Phytolacca Decandra, Guaiacum, Ledum Palustre, Conium Maculatum GEL TOPICAL 20130320 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CONIUM MACULATUM FLOWERING TOP; GUAIACUM OFFICINALE RESIN; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT 30; 6; 3; 6; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0004_ee2fb53f-7a23-42af-9aaf-aa7309256964 43846-0004 HUMAN PRESCRIPTION DRUG MUSCLE RESCUE Arnica Montana, Rhus Toxicodendron, Phytolacca Decandra, Pulsatilla, Ruta Graveolens GEL TOPICAL 20130812 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 3; 12; 12; 12; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0005_8fa18203-76a9-45e5-bdba-429a72f21f6f 43846-0005 HUMAN OTC DRUG Muscle Ice Phytolacca Decandra, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Ruta Graveolens, Magnesia Phosphorica GEL TOPICAL 20130308 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. BELLIS PERENNIS; COMFREY ROOT; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE 6; 3; 6; 9; 1; 6; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0006_3479abcd-f16a-4a87-bab3-35257600d8b0 43846-0006 HUMAN OTC DRUG Tendon Rescue Bryonia, Ruta Graveolens, Bellis Perennis, Argentum Metallicum GEL TOPICAL 20130319 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. BELLIS PERENNIS; BRYONIA ALBA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILVER 6; 3; 3; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0007_6669b70c-c932-492c-8cad-b3f8fe0e9997 43846-0007 HUMAN OTC DRUG Hot Flash Rescue Capsicum Annuum, Pulsatilla, Sanguinaria Canadensis SPRAY TOPICAL 20130319 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CAPSICUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43846-0008_d94a6f09-1f1d-489e-ac03-6404a101fffd 43846-0008 HUMAN OTC DRUG Eczema Rescue Carbolicum Acidum, Fagopyrum Exculentum, Hydrastis Canadensis, Hydrocotyle Asiatica, Juglans Regia, Vinca Minor LOTION TOPICAL 20130319 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CENTELLA ASIATICA; FAGOPYRUM ESCULENTUM; GOLDENSEAL; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; PHENOL; VINCA MINOR 30; 30; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0009_d411a613-b8ec-4337-8b56-8e67199277a0 43846-0009 HUMAN OTC DRUG Back and Neck Rescue Hypericum Perforatum, Phytolacca Decandra, Guaiacum, Ledum Palustre, Conium Maculatum GEL TOPICAL 20130319 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CONIUM MACULATUM FLOWERING TOP; GUAIACUM OFFICINALE RESIN; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT 30; 6; 3; 6; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0011_f6d1c1cf-e5e4-4345-a417-9704236f2c4a 43846-0011 HUMAN OTC DRUG Shingles Rescue Althaea Officinalis, Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Toxicodendron GEL TOPICAL 20130319 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ALTHAEA OFFICINALIS ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; PLANTAGO MAJOR; SMILAX REGELII ROOT; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF 12; 12; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0013_13c53e45-533e-497c-b91d-b07ee22a48ae 43846-0013 HUMAN OTC DRUG Joint Rescue Symphytum Officinale, Capsicum Annuum, Ledum Palustre, Colchicum Autumnale, Rhododendron Chrysanthum GEL TOPICAL 20130318 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CAPSICUM; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 6; 12; 3; 6; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0014_b7829672-f079-4d57-9e5a-9ce0b8f87a8b 43846-0014 HUMAN OTC DRUG Sciatic Rescue Phytolacca Decandra, Gnaphalium Polycephalum, Colocynthis, Gelsemium Sempervirens GEL TOPICAL 20120824 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT; PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM 6; 6; 1; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0015_d917d881-4cbe-4e36-8ad2-6bb32f38dcb4 43846-0015 HUMAN PRESCRIPTION DRUG Back and Neck Rescue Hypericum Perforatum, Phytolacca Decandra, Guaiacum, Ledum Palustre, Conium Maculatum LOTION TOPICAL 20120919 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CONIUM MACULATUM FLOWERING TOP; GUAIACUM OFFICINALE RESIN; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT 30; 6; 3; 6; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0016_d8f757b6-9653-42e7-9a80-90f154b0e073 43846-0016 HUMAN OTC DRUG Arnica Plus Arnica Montana, Hamamelis Virginiana, Rhus Toxicodendron, LOTION TOPICAL 20120919 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0017_1949c9a2-0629-4a4a-975e-9d8b5ae70bd9 43846-0017 HUMAN OTC DRUG Eczema Rescue Carbolicum acidum, Fagopyrum esculentum, Hydrastis canadensis, Hydrocotyle asiatica, Juglans regia, Vinca minor, LOTION TOPICAL 20120914 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CENTELLA ASIATICA; FAGOPYRUM ESCULENTUM; HYDRASTIS CANADENSIS WHOLE; JUGLANS REGIA FLOWERING TOP; PHENOL; VINCA MINOR 30; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0018_26726f7e-72a7-4530-a45e-1e158dae44ec 43846-0018 HUMAN OTC DRUG Muscle Ice Phytolacca Decandra, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Ruta Graveolens, Magnesia Phosphorica, Silicea LOTION TOPICAL 20120919 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. BELLIS PERENNIS; COMFREY ROOT; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE 6; 3; 6; 9; 1; 6; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; umol/g; [hp_X]/g; [hp_X]/g 43846-0019_0ea9984d-0289-43b9-95b2-844e946048cc 43846-0019 HUMAN OTC DRUG ECZEMA RESCUE CABOLICUM ACIDUM, FAGOPYRUM ESCULENTUM, HYDRASTIS CANADENSIS, HYDROCOTYLE ASIATICA, JUGLANS REGIA, VINCA MINOR LOTION TOPICAL 20141215 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CENTELLA ASIATICA; FAGOPYRUM ESCULENTUM; GOLDENSEAL; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; PHENOL; VINCA MINOR 30; 30; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0020_86c471ba-4d14-454f-9006-dde63b66759e 43846-0020 HUMAN OTC DRUG Back and Neck Rescue Hypericum Perforatum, Phytolacca Decandra, Guaiacum, Ledum Palustre, Conium Maculatum GEL TOPICAL 20130318 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CONIUM MACULATUM FLOWERING TOP; GUAIAC; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT 30; 6; 3; 6; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0021_620fa40b-ee6c-48f0-9147-204ebb887d69 43846-0021 HUMAN OTC DRUG Arnica Plus Arnica Montana, Hamamelis Virginiana, Rhus Toxicodendron GEL TOPICAL 20130314 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; HAMAMELIS VIRGINIANA BARK; TOXICODENDRON PUBESCENS LEAF 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0022_47398224-62e7-483a-a2a1-bb8b8a2a88fa 43846-0022 HUMAN OTC DRUG Muscle Ice Phytolacca Decandra, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Ruta Graveolens, Magnesia Phosphorica, Silicea GEL TOPICAL 20130925 UNAPPROVED HOMEOPATHIC Peaceful Mountain BELLIS PERENNIS; COMFREY ROOT; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE 6; 3; 6; 9; 1; 6; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0023_6f282b64-3db7-44f1-8ca5-836ef9a54676 43846-0023 HUMAN OTC DRUG Tendon Rescue Bryonia, Ruta Graveolens, Bellis Perennis, Argentum Metallicum GEL TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. BELLIS PERENNIS; BRYONIA ALBA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILVER 6; 3; 3; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0024_143e28ec-16de-4427-a6cc-02a5b0f1d4e5 43846-0024 HUMAN OTC DRUG Sciatic Rescue Phytolacca Decandra, Gnaphalium Polycephalum, Colocynthis, Gelsemium Sempervirens GEL TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT; PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM 6; 6; 1; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0025_84b060ac-7e78-42ef-b463-7b0e240b5cbe 43846-0025 HUMAN OTC DRUG Muscle Rescue Arnica Montana, Rhus Toxicodendron, Phytolacca Decandra, Pulsatilla, Ruta Graveolens GEL TOPICAL 20130318 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 3; 12; 12; 12; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0026_09d17c56-37c8-4ba2-a264-2231743ae0cb 43846-0026 HUMAN OTC DRUG Arnica Plus Arnica Montana, Hamamelis Virginiana, Rhus Toxicodendron GEL TOPICAL 20121011 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; HAMAMELIS VIRGINIANA BARK; TOXICODENDRON PUBESCENS LEAF 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0027_89438149-8efb-49e9-854f-7df3b3a3945c 43846-0027 HUMAN OTC DRUG Joint Rescue Symphytum Officinale, Capsicum Annuum, Ledum Palustre, Colchicum Autumnale, Rhododendron Chrysanthum, Ruta Graveolens GEL TOPICAL 20121011 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CAPSICUM; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 6; 12; 3; 6; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0028_4e75f663-1c22-4a37-81f4-73af944e5c3a 43846-0028 HUMAN OTC DRUG Shingles Rescue Plus Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Toxicodendron, Sarsaparilla GEL TOPICAL 20130925 UNAPPROVED HOMEOPATHIC Peaceful Mountain CROTON TIGLIUM SEED; PLANTAGO MAJOR; SARSAPARILLA; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0029_67697c06-ea2e-414e-864c-f84c91547fe6 43846-0029 HUMAN OTC DRUG Joint Rescue Symphytum Officinale, Capsicum Annuum, Ledum Palustre, Colchicum Autumnale, Rhododendron Chrysanthum, Ruta Graveolens GEL TOPICAL 20130913 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CAPSICUM; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 6; 12; 3; 6; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0030_a24d746c-1ba3-4875-a268-708b662b59b6 43846-0030 HUMAN OTC DRUG Sciatic Rescue Phytolacca Decandra, Gnaphalium Polycephalum, Colocynthis, Gelsemium Sempervirens GEL TOPICAL 20130228 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT; PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM 6; 6; 1; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0031_a36d71a6-adaa-4686-98bd-c32971812b24 43846-0031 HUMAN OTC DRUG Cold Sore Rescue BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA GEL TOPICAL 20141208 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. RANUNCULUS BULBOSUS; SILICON DIOXIDE; SODIUM BORATE; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0032_29017b5e-2385-423e-a4b0-63ff641b269c 43846-0032 HUMAN OTC DRUG Arnica Plus Arnica Montana, Hamamelis Virginiana, Rhus Toxicodendron LOTION TOPICAL 20130104 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0033_1ff980df-19d7-4286-bc2d-7e441a534fe7 43846-0033 HUMAN OTC DRUG Hot Flash Rescue Capsicum Annuum, Pulsatilla, Sanguinaria Candensis LOTION TOPICAL 20140102 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CAPSICUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0034_fd3f1842-31de-4f03-9ee6-79e852ae20bb 43846-0034 HUMAN OTC DRUG Back and Neck Rescue Hypericum Perforatum, Phytolacca Decandra, Guaiacum, Ledum Palustre, Conium Maculatum GEL TOPICAL 20130417 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CONIUM MACULATUM FLOWERING TOP; GUAIAC; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT 30; 6; 3; 6; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0035_5489e385-a114-4757-80c7-1688aaaa5cf2 43846-0035 HUMAN OTC DRUG MUSCLE RESCUE Arnica Montana, Rhus Toxicodendron, Phytolacca Decandra, Pulsatilla, Ruta Graveolens GEL TOPICAL 20130807 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 3; 12; 12; 12; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0036_0261565f-f41b-4c8a-a2be-63aeecb293cf 43846-0036 HUMAN OTC DRUG HOT FLASH RESCUE NOT APPLICABLE LOTION TOPICAL 20141001 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CAPSICUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0037_8b66f47d-0914-4050-b230-e89d6e439e1d 43846-0037 HUMAN OTC DRUG Chafe Rescue Bryonia, Arsenicum Iodatum, Baryta Carbonica, Alumina, Calendula Officinalis, Sulphuricum Acidum, Symphytum Officinale LOTION TOPICAL 20140102 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc ALUMINUM OXIDE; ARSENIC TRIIODIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; SULFURIC ACID 12; 6; 8; 1; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43846-0040_0f2f3628-1cca-45af-b61b-41dcd01d08c8 43846-0040 HUMAN OTC DRUG Acne Rescue Borax, Carbo Vegetabilis, Carboneum Sulphuratum, Causticum, Natrum Muriaticum, Silicea GEL TOPICAL 20140710 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ACTIVATED CHARCOAL; CARBON DISULFIDE; CAUSTICUM; SILICON DIOXIDE; SODIUM BORATE; SODIUM CHLORIDE 12; 12; 12; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43853-0001_b431162b-91b0-4c9c-b45f-c320622a9ce2 43853-0001 HUMAN PRESCRIPTION DRUG Estrogen and Progesterone Agnus castus, Angelica sinensis, radix, Apis mellifica, Arnica montana, Cimicifuga racemosa, Estradiol, Estriol, Folliculinum, SPRAY ORAL 20140205 UNAPPROVED HOMEOPATHIC ProBLEN ANGELICA SINENSIS ROOT; APIS MELLIFERA; ARNICA MONTANA; ASIAN GINSENG; BLACK COHOSH; CHASTE TREE; ESTRADIOL; ESTRIOL; ESTRONE; GALIUM APARINE; GLYCYRRHIZA GLABRA; PROGESTERONE; SEPIA OFFICINALIS JUICE; SUS SCROFA OVARY; THUJA OCCIDENTALIS LEAF; VISCUM ALBUM FRUITING TOP 3; 6; 6; 3; 3; 3; 9; 9; 9; 3; 3; 6; 30; 30; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Progesterone [Chemical/Ingredient],Progesterone [EPC] 43853-0002_f9218a81-ac41-4bcb-95d0-f2583c7c895d 43853-0002 HUMAN OTC DRUG HGH Plus IGF1 and IGF2 Arnica Montana, Deer Antler Velvet, Hepar Bovine, HGH, IGF, Pituitaria Glandula Bovine, Thuja Occidentalis LIQUID ORAL 20130917 UNAPPROVED HOMEOPATHIC ProBLEN ARNICA MONTANA; BEEF LIVER; BOS TAURUS PITUITARY GLAND; CERVUS ELAPHUS VELVET; MECASERMIN; SOMATROPIN; THUJA OCCIDENTALIS LEAF 6; 6; 5; 8; 8; 24; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43853-0005_405a1bd5-92b3-4304-a77a-83af671815b6 43853-0005 HUMAN OTC DRUG Testosterone Avena Sativa, Carduus Marianus, Damiana, Galium Aparine, Hamamelis Virginiana, Hepar Bovine, Korean Ginseng, Nuphar Luteum, LIQUID ORAL 20130916 UNAPPROVED HOMEOPATHIC ProBLEN ASIAN GINSENG; AVENA SATIVA FLOWERING TOP; BEEF LIVER; BOS TAURUS TESTICLE; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; NUPHAR LUTEUM ROOT; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; SILYBUM MARIANUM SEED; TESTOSTERONE; THUJA OCCIDENTALIS LEAF; TURNERA DIFFUSA LEAFY TWIG 1; 1; 6; 6; 3; 1; 2; 1; 1; 1; 30; 200; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 43853-0006_f938b86b-ef23-48cb-abb6-859564c97e3f 43853-0006 HUMAN OTC DRUG Thyroid Calcarea Iodata, Ferrum Metallicum, Fucus Vesiculosus, Lapis Albus, Natrum Muriaticum, Spongia Tosta LIQUID ORAL 20130228 UNAPPROVED HOMEOPATHIC ProBLEN CALCIUM HEXAFLUOROSILICATE; CALCIUM IODIDE; FUCUS VESICULOSUS; IRON; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID 30; 30; 3; 12; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43853-0007_f4d26fe0-e648-4689-bfa9-616fbfd8945c 43853-0007 HUMAN OTC DRUG HGH HGH, Hepar Bovinum, Pituitary Bovinum LIQUID ORAL 20130306 UNAPPROVED HOMEOPATHIC ProBLEN BEEF LIVER; BOS TAURUS PITUITARY GLAND; SOMATROPIN 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43853-0008_3992ec41-9aae-4e88-83be-6032a43e5d77 43853-0008 HUMAN OTC DRUG Adrenal and DHEA Aralia Quinquefolia, Arnica Montana, Avena Sativa, Carduus Marianus, Dhea, Glandula Suprarenalis Suis, L-Arginine LIQUID ORAL 20130423 UNAPPROVED HOMEOPATHIC ProBLEN .ALPHA.-TOCOPHEROL; AMERICAN GINSENG; ARGININE; ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; PHOSPHORIC ACID; PRASTERONE; SILYBUM MARIANUM SEED; SODIUM CHLORIDE; SUS SCROFA ADRENAL GLAND; THUJA OCCIDENTALIS LEAF 10; 3; 6; 3; 3; 200; 6; 3; 30; 12; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 43853-0010_f3e5b857-cf2f-4284-b55c-c19387fcd8f4 43853-0010 HUMAN OTC DRUG DNA RNA Arnica montana, Avena sativa, Damiana, DNA, Korean Ginseng, Oleum animale, Pituitaria glandula (bovine), RNA, Thuja occidentalis, SPRAY ORAL 20140505 UNAPPROVED HOMEOPATHIC ProBLEN ARNICA MONTANA; ASIAN GINSENG; AVENA SATIVA FLOWERING TOP; BOS TAURUS PITUITARY GLAND; CERVUS ELAPHUS HORN OIL; HERRING SPERM DNA; SACCHAROMYCES CEREVISIAE RNA; THUJA OCCIDENTALIS LEAFY TWIG; TURNERA DIFFUSA LEAFY TWIG 6; 3; 3; 5; 6; 9; 9; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43853-0100_3ce8c929-1204-42c5-a44c-5643e0dfbe28 43853-0100 HUMAN PRESCRIPTION DRUG HGH Plus Arnica montana, Deer antler velvet, Hepar bovine, HGH, IGF-1, Pituitaria glandula bovine, Thuja occidentalis, SPRAY ORAL 20140121 UNAPPROVED HOMEOPATHIC ProBLEN ARNICA MONTANA; BEEF LIVER; BOS TAURUS PITUITARY GLAND; CERVUS ELAPHUS VELVET; MECASERMIN; SOMATROPIN; THUJA OCCIDENTALIS LEAF 6; 6; 5; 8; 8; 24; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient],Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] 43857-0001_6181dcf0-470c-42f2-ae04-a01b901e3fd8 43857-0001 HUMAN OTC DRUG Ligatone Arnica montana, Bryonia, Calcarea phosphorica, Causticum, Kali caronicum, Manganese gluconate, Mezereum, Rhus toxicodendron, Ruta graveolens, Silicea, LIQUID ORAL 20120413 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; DAPHNE MEZEREUM BARK; MANGANESE GLUCONATE; POTASSIUM CARBONATE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0002_f0aff8b3-24ef-47e6-af3c-523001f4d5f1 43857-0002 HUMAN OTC DRUG Additox Phytolacca Decandra, Trifolium Pratense, Xanthoxylum Fraxineum, Arsenicum Album, Belladonna, Chelidonium Majus LIQUID ORAL 20130110 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; ASPARTAME; ATROPA BELLADONNA WHOLE; BENZALKONIUM CHLORIDE; CHELIDONIUM MAJUS; FORMALDEHYDE; LYCOPODIUM CLAVATUM SPORE; METHYLENE CHLORIDE; METHYLPARABEN; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK; ZINC OXIDE 12; 30; 12; 30; 12; 30; 12; 30; 30; 12; 3; 30; 30; 30; 30; 3; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0003_e811eff2-33ae-4f07-a34b-9c79221aa3d2 43857-0003 HUMAN OTC DRUG Evtox Cochlearia Officinalis, Echinacea, Hydrastis Canadensis, Lomatium Dissectum, Tabebuia Imipetiginosa, Propolis, Glandula Suprarenalis Suis LIQUID ORAL 20130111 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARANEUS DIADEMATUS; COCHLEARIA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; GOLDENSEAL; HUMAN HERPESVIRUS 4; HYDROCHLORIC ACID; IPECAC; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PROPOLIS WAX; SILICON DIOXIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; TOXICODENDRON PUBESCENS LEAF 12; 3; 3; 3; 30; 12; 12; 3; 12; 12; 6; 12; 8; 8; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0004_070e52c8-5f44-4175-968b-cc251d3458de 43857-0004 HUMAN PRESCRIPTION DRUG Inflammation II Astragalus Membranaceus, Echinacea, Hydrastis Canadensis, Sarsaparilla, Tabebuia Impetiginosa, Thyroidinum, Aurum Metallicum LIQUID ORAL 20130111 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ASTRAGALUS PROPINQUUS ROOT; CARBO ANIMALIS; CAUSTICUM; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; GOLD; GOLDENSEAL; PHOSPHORUS; SMILAX REGELII ROOT; SODIUM SULFATE; SULFUR; SUS SCROFA THYROID; TABEBUIA IMPETIGINOSA BARK; THUJA OCCIDENTALIS LEAFY TWIG 3; 12; 12; 3; 30; 12; 3; 30; 3; 30; 30; 8; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 43857-0005_12809bde-472a-41ef-a0af-c1058295dbd0 43857-0005 HUMAN OTC DRUG Metalogin Allium Sativum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula, Stillingia Sylvatica LIQUID ORAL 20130111 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALUMINUM; ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; FRANGULA ALNUS BARK; GADOLINIUM OXIDE; GARLIC; GERMANIUM SESQUIOXIDE; GLYCYRRHIZA GLABRA; GOLD; HOLMIUM; IRIDIUM; IRON; LANTHANUM OXIDE; LEAD; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; METHIONINE; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PHYTOLACCA AMERICANA ROOT; PLATINUM; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; SELENIUM DIOXIDE; SILVER; STILLINGIA SYLVATICA ROOT; STRONTIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA THYROID; TANTALUM; TERBIUM; THALLIUM; TIN; TRIFOLIUM PRATENSE FLOWER; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC 12; 12; 3; 12; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 3; 12; 3; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 6; 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 12; 12; 8; 12; 3; 12; 12; 6; 12; 12; 12; 12; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0006_10cb6b78-8513-437c-9b9c-2ded3c09b48b 43857-0006 HUMAN OTC DRUG Pituitary Forte Hypothalamus (suis), Pineal (suis), Pituitary (whole suis), SPRAY ORAL 20120417 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SUS SCROFA HYPOTHALAMUS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0007_44f58ac2-a38a-416c-b087-3dee85cf9e43 43857-0007 HUMAN OTC DRUG Pollen Mix Sorrel mixture, Grass mixture, Goldenrod, Red Clover, Alfalfa, Ragweed mixture, tree mixture LIQUID ORAL 20130114 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACER NEGUNDO POLLEN; AGROSTIS GIGANTEA TOP; ALFALFA; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA; AMBROSIA PSILOSTACHYA TOP; AMBROSIA TRIFIDA POLLEN; BETULA OCCIDENTALIS POLLEN; CARYA OVATA POLLEN; DACTYLIS GLOMERATA TOP; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; PHLEUM PRATENSE TOP; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS TOP; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; QUERCUS RUBRA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS TOP; SALIX NIGRA POLLEN; SOLIDAGO VIRGAUREA FLOWERING TOP; TRIFOLIUM PRATENSE FLOWER; ULMUS AMERICANA POLLEN 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0008_1c6df30f-eaef-480f-b8bc-95093bf7a465 43857-0008 HUMAN OTC DRUG Serotonin Serotonin LIQUID ORAL 20121008 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SEROTONIN 6 [hp_X]/mL 43857-0009_ba789991-4ebe-4795-8506-93c27a9a135c 43857-0009 HUMAN OTC DRUG Systemic Detox Berberis Vulgaris, Boldo, Chelidonium Majus, Hydrastis Canadensis, Lappa Major, Taraxacum Officinale, Trifolium Pratense LIQUID ORAL 20130116 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALOE; ARCTIUM LAPPA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; GINKGO; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MARSDENIA CONDURANGO BARK; PEUMUS BOLDUS LEAF; SMILAX REGELII ROOT; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TABEBUIA IMPETIGINOSA BARK; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TRIFOLIUM PRATENSE FLOWER 30; 3; 3; 12; 3; 12; 30; 6; 3; 12; 6; 3; 12; 30; 30; 6; 3; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0010_75cfda91-a0f6-4b31-aa85-3f842e634fd4 43857-0010 HUMAN OTC DRUG Thyrotox Chondrus Crispus, Fucus Vesiculosus, Thyroidinum, Belladonna, Calcarea Carbonica, Conium Maculatum LIQUID ORAL 20130116 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA WHOLE; CHONDRUS CRISPUS; CONIUM MACULATUM FLOWERING TOP; FUCUS VESICULOSUS; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SUS SCROFA THYROID 12; 3; 12; 3; 12; 12; 12; 12; 12; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0011_d7b73fe2-2e2f-4a6e-8e64-210b6eec2eba 43857-0011 HUMAN OTC DRUG Candida Combo Candida Albicans LIQUID ORAL 20130116 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CANDIDA ALBICANS 12 [hp_X]/mL 43857-0012_645efcb3-6072-4b64-b794-ee086185e16a 43857-0012 HUMAN OTC DRUG Sciatica HP Aconitum Napellus, Aesculus Hippocastanum, Colchicum Autumnale, Hypericum Perforatum, Magnesia Phosphorica, LIQUID ORAL 20130117 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; COLCHICUM AUTUMNALE BULB; HORSE CHESTNUT; HYPERICUM PERFORATUM; LEAD; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0013_f9ded008-ece9-4ef4-8864-141133330ffe 43857-0013 HUMAN OTC DRUG Hepatatox Triticum Aestivum, Chelidonium Majus, Taraxacum Officinale, Glutathione, Hepar Suis, Thyroidinum, Lycopodium Clavatum LIQUID ORAL 20130117 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACETIC ACID; BENZOIC ACID; BENZYL ALCOHOL; BORIC ACID; CHELIDONIUM MAJUS; CHLORINE; CORTICOTROPIN; CORTISONE ACETATE; ESTRONE; EUGENOL; GLUTATHIONE; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LEAD; LYCOPODIUM CLAVATUM SPORE; PETROLATUM; PHENYLBUTAZONE; PHOSPHORIC ACID; PORK LIVER; POTASSIUM SORBATE; RESORCINOL; SALICYLIC ACID; SORBITOL; STEARYL ALCOHOL; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA THYROID; TARAXACUM OFFICINALE; TRITICUM AESTIVUM WHOLE; XYLITOL 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 6; 30; 30; 30; 12; 30; 30; 12; 8; 30; 30; 30; 30; 30; 12; 8; 3; 1; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0015_202d6d06-264c-4ddc-9e10-6e485ed7b403 43857-0015 HUMAN OTC DRUG Drainage Echinacea, Phytolacca Decandra, Trifolium Pratense, Calcarea Iodata, Kali Muriaticum, Nitricum Acidum, Phosphoricum Acidum LIQUID ORAL 20130117 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CALCIUM IODIDE; ECHINACEA, UNSPECIFIED; NITRIC ACID; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; POTASSIUM CHLORIDE; SULFUR IODIDE; TRIFOLIUM PRATENSE FLOWER 12; 3; 12; 12; 3; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0016_cf85ee56-7355-43e0-a5bb-c89d1da870c8 43857-0016 HUMAN OTC DRUG Allerforce Chondrus Crispus, Glycyrrhiza Glabra, Sarsaparilla, Zingiber Officinale, Adrenalinum, Allium Cepa, Aralia Racemosa LIQUID ORAL 20130219 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; CHONDRUS CRISPUS; EPINEPHRINE; GINGER; GLYCYRRHIZA GLABRA; IODINE; LYTTA VESICATORIA; ONION; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SMILAX REGELII ROOT; SODIUM CARBONATE; TOXICODENDRON PUBESCENS LEAF 12; 12; 3; 8; 3; 3; 12; 12; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0017_93b09755-c357-4da2-a2d2-fa651c926592 43857-0017 HUMAN OTC DRUG Injury Topical Calendula Officinalis, Arnica Montana, Symphytum Officinale, Hypericum Perforatum, Bellis Perennis, Carbo Vegetabilis LOTION TOPICAL 20130218 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACHILLEA MILLEFOLIUM; ACTIVATED CHARCOAL; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 12; 12; 1; 12; 1; 3; 12; 3; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 43857-0018_13e72071-22a9-4bcc-9519-6639549295cc 43857-0018 HUMAN OTC DRUG Lym D Chelidonium Majus, Echinacea, Hydrastis Canadensis, Nasturtium Aquaticum, Taraxacum Officinale, Trifolium Pratense LIQUID ORAL 20130222 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; BORRELIA BURGDORFERI; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; NASTURTIUM OFFICINALE; PHOSPHORUS; PROTORTONIA CACTI; SUS SCROFA THYMUS; SUS SCROFA THYROID; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA 12; 12; 3; 3; 3; 200; 12; 3; 12; 12; 8; 8; 3; 12; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0019_464da1ac-4a79-41d1-927d-1f554dab6ed1 43857-0019 HUMAN OTC DRUG Dopamine Dopamine, LIQUID ORAL 20120501 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. DOPAMINE 6 [hp_X]/mL 43857-0020_830c7917-c926-4cf5-9254-1b2d2529124f 43857-0020 HUMAN OTC DRUG Melatonin Forte Melatonin, Nadidum, Niacin, Pyridoxinum hydrochloricum, Zincum sulphuricum, Hypothalamus (suis), Lithium carbonicum, Magnesia carbonica, Pineal (suis), Pituitary (suis), SPRAY ORAL 20120504 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. LITHIUM CARBONATE; MAGNESIUM CARBONATE; MELATONIN; NADIDE; NIACIN; PYRIDOXINE HYDROCHLORIDE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; ZINC SULFATE HEPTAHYDRATE 8; 8; 6; 6; 6; 6; 8; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0022_a424047f-73eb-4cb7-85a2-9bac4176671c 43857-0022 HUMAN OTC DRUG Natural Testosterone Avena sativa, Epimedium, Lycopodium clavatum, Androstenedione, Damiana, Testosterone, Agnus castus, SPRAY ORAL 20120522 UNAPPROVED HOMEOPATHIC BioActive Nutritional ANDROSTENEDIONE; AVENA SATIVA FLOWERING TOP; CHASTE TREE; EPIMEDIUM GRANDIFLORUM FLOWERING TOP; EPIMEDIUM GRANDIFLORUM TOP; LYCOPODIUM CLAVATUM SPORE; TESTOSTERONE; TURNERA DIFFUSA LEAFY TWIG 6; 3; 12; 3; 3; 3; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0023_abad14b9-2556-4c5e-b29e-6d578d053c80 43857-0023 HUMAN OTC DRUG NADH Plus Nadidum, Adenosinum cyclophosphoricum, Calcium D-pantothenate, Cholinum, Roboflavinum, Ubiquinone, Dimethyl glycine, SPRAY ORAL 20120531 UNAPPROVED HOMEOPATHIC BioActive Nutritional ADENOSINE CYCLIC 3',5'-PHOSPHATE; CALCIUM PANTOTHENATE; CHOLINE HYDROXIDE; N,N-DIMETHYLGLYCINE; NADIDE; RIBOFLAVIN; UBIDECARENONE 6; 6; 6; 7; 4; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0024_cf8d3e00-3404-4f6c-80db-8e5124324a70 43857-0024 HUMAN OTC DRUG Endocrine Balancer Fucus vesiculosus, Glycyrrhiza glabra, Sarsaparilla, Glandula suprarenalis suis, Pinus sylvestris, Thyroidinum (suis), Iodium, LIQUID ORAL 20120514 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. FUCUS VESICULOSUS; GLYCYRRHIZA GLABRA; IODINE; PINUS SYLVESTRIS LEAFY TWIG; SMILAX REGELII ROOT; SUS SCROFA ADRENAL GLAND; THYROID, PORCINE 3; 3; 12; 6; 3; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0025_8fb13e24-0a41-4475-9115-0089d9d9234a 43857-0025 HUMAN OTC DRUG Hemoforce Urtica Urens, Ferrum Muriaticum, Aranea Diadema, Aurum Metallicum, Cinchona Officinalis, Cobaltum Gluconate, Phosphorus LIQUID ORAL 20130121 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARANEUS DIADEMATUS; CINCHONA OFFICINALIS BARK; COBALTOUS GLUCONATE; FERRIC CHLORIDE HEXAHYDRATE; GOLD; PHOSPHORUS; URTICA URENS 12; 12; 12; 6; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0026_664222bc-0509-45fa-a952-61f23f6cd7f5 43857-0026 HUMAN OTC DRUG Thyro Tonic Chelidonium majus, Spongia tosta, Lac defloratum, Fucus vesiculosus, Hepar suis, Pituitary (suis), Thyroidinum (suis), Calcarea carbonica, Ferrum iodatum, Iodium, Kali iodatum, LIQUID ORAL 20120514 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHELIDONIUM MAJUS; FERROUS IODIDE; FUCUS VESICULOSUS; IODINE; MOLYBDENUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK LIVER; POTASSIUM IODIDE; PULSATILLA VULGARIS; SKIM MILK; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE 3; 12; 6; 12; 12; 12; 8; 12; 12; 4; 3; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0027_efc76f53-859f-4b0d-b5fb-c28cc7385f93 43857-0027 HUMAN OTC DRUG Geopathic Stress Alfalfa, Avena sativa, Fucus vesiculosus, Symphytum officinale, Agate, Calcarea carbonica, Ferrum metallicum, Phosphorus, Quartz, Silicea, Cuprum metallicum, Tarentula hispana, LIQUID ORAL 20120514 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALCOHOL, X-RAY EXPOSED (1000 RAD); ALFALFA; AVENA SATIVA FLOWERING TOP; COMFREY ROOT; COPPER; FUCUS VESICULOSUS; IRON; LYCOSA TARANTULA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SILICON DIOXIDE 40; 3; 3; 3; 30; 3; 12; 30; 12; 12; 12 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0028_887c03f7-4337-4dcc-a825-a16dabd1d5d8 43857-0028 HUMAN OTC DRUG Immuno Fortifier Echinacea 3X, Hydrastis Canadensis 3X, Myrrha 3X, Naturtium Aquaticum 3X, Osha 3X, Tabebuia Impetiginaosa 3X LIQUID ORAL 20120820 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc ASCORBIC ACID; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; FENUGREEK SEED; GOLDENSEAL; LIGUSTICUM PORTERI ROOT; MYRRH; NASTURTIUM OFFICINALE; PHOSPHORIC ACID; SILICON DIOXIDE; SUS SCROFA BONE MARROW; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK 6; 12; 3; 3; 3; 3; 3; 3; 12; 12; 8; 8; 8; 8; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 43857-0029_ca845fb4-b958-4897-9276-68670c179a81 43857-0029 HUMAN OTC DRUG Calciforce Arnica Montana, Chamomilla, Echinacea, Symphytum Officinale, Boron Gluconate, Calcarea Phosphorica LIQUID ORAL 20130130 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; BORON GLUCONATE; CALCIUM FLUORIDE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; HEKLA LAVA; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE 3; 6; 12; 3; 3; 12; 12; 3; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0030_da03ea71-4d69-4a36-b959-c342b7773d99 43857-0030 HUMAN OTC DRUG CVTox Cochlearia armoracia, Echinacea, Hydrastis canadensis, Lomatium dissectum, Tabebuia impetiginosa, Propolis, Glandula suprarenalis bovinum, Thymus gland (suis), Aranea diadema, Ipecacuanha, Lycopodium clavatum, Muriaticum acidum, Nitricum acidum, Phosphoricum acidum, LIQUID ORAL 20120522 UNAPPROVED HOMEOPATHIC BioActive Nutritional ARANEUS DIADEMATUS; BOS TAURUS ADRENAL GLAND; ECHINACEA, UNSPECIFIED; GOLDENSEAL; HEPATITIS B VIRUS; HORSERADISH; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4; HUMAN HERPESVIRUS 3; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 5; HYDROCHLORIC ACID; IPECAC; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MEASLES VIRUS; NITRIC ACID; PHOSPHORIC ACID; POLIOVIRUS; PROPOLIS WAX; SILICON DIOXIDE; SUS SCROFA THYMUS; TOXICODENDRON PUBESCENS LEAF 12; 8; 3; 3; 33; 3; 15; 15; 30; 30; 30; 12; 12; 3; 12; 30; 12; 12; 30; 6; 12; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0031_e36f7efe-ede1-4d6d-89d7-0228eb2fee10 43857-0031 HUMAN OTC DRUG Hypopituitaryplex Aralia Quinquefolia, Hydrocotyle Asiatica, Polygonum Multiflorum, Hypothalamus, Pituitary, Germanium Sesquioxide, LIQUID ORAL 20130121 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMERICAN GINSENG; CENTELLA ASIATICA; FALLOPIA MULTIFLORA ROOT; GERMANIUM SESQUIOXIDE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND 3; 3; 3; 12; 8; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0032_e5c2a9a1-d044-4010-83f0-0a75a0c4a0b6 43857-0032 HUMAN OTC DRUG Asthmaforce Arnica montana, Asclepias tuberosa, Eriodictyon californicum, Eucalyptus globulus, Lobelia inflata, Plantago major, Trifolium pratense, Arsenicum album, Belladonna, Bryonia, Carbo vegetabilis, Grindelia, Kali carbonicum, Natrum sulphuricum, Pulsatilla, LIQUID ORAL 20120601 UNAPPROVED HOMEOPATHIC BioActive Nutritional ACTIVATED CHARCOAL; ARNICA MONTANA; ARSENIC TRIOXIDE; ASCLEPIAS TUBEROSA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; ERIODICTYON CALIFORNICUM LEAF; EUCALYPTUS GLOBULUS LEAF; GRINDELIA HIRSUTULA FLOWERING TOP; LOBELIA INFLATA; PLANTAGO MAJOR; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SODIUM SULFATE; TRIFOLIUM PRATENSE FLOWER 12; 3; 12; 3; 12; 12; 3; 3; 12; 3; 3; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0033_61bf638b-a960-4484-9817-4ab82e072148 43857-0033 HUMAN OTC DRUG Gynobalance Dehydroepiandrosterone, Estradiol, Pregnenolone, Progesterone, Testosterone LIQUID ORAL 20130118 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ESTRADIOL; PRASTERONE; PREGNENOLONE; PROGESTERONE; TESTOSTERONE 8; 6; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0034_0a00ef0c-4675-4042-8b69-2f4df414762e 43857-0034 HUMAN OTC DRUG Otoflam HP Belladonna, Conium maculatum, Dulcamara, Hepar sulphuris calcareum, Kali bichromicum, Mercurius solubilis, Pulsatilla, Silicea, Chamonilla, LIQUID ORAL 20120713 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SOLANUM DULCAMARA TOP 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0036_0b90056c-3795-4c07-9d23-7138b8b9c109 43857-0036 HUMAN OTC DRUG Tri Estrogen Folliculinum, OOphorinum, SPRAY ORAL 20120601 UNAPPROVED HOMEOPATHIC BioActive Nutritional ESTRONE; SUS SCROFA OVARY 6; 6 [hp_X]/mL; [hp_X]/mL 43857-0037_1ba41a8c-03e8-47f5-9495-6d2348a47c40 43857-0037 HUMAN OTC DRUG Thyroid HP Baryta Carbonica, Calcarea Carbonica, Fucus Vesiculosus, Iodium, Natrum Muriaticum, Pulsatilla, Spongia Tosta LIQUID ORAL 20130124 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BARIUM CARBONATE; FUCUS VESICULOSUS; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0038_e771074a-3c1e-45f0-978d-de72d845f8f8 43857-0038 HUMAN OTC DRUG Allergen I Potassium Gluconate, Glandula Suprarenalis Bovine, Hepar Bovine, Arsenicum Album, Lycopodium Clavatum, Nux Vomica, Phosphorus, Cortisone Aceticum, Histaminum Hydrochloricum, LIQUID ORAL 20130117 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALPINE STRAWBERRY; ARSENIC TRIOXIDE; BANANA; BEEF; BEEF LIVER; BITTER ALMOND; BLACK PEPPER; BLACK WALNUT; BOS TAURUS ADRENAL GLAND; BRAZIL NUT; CASEIN, LACTOCOCCUS LACTIS CULTURED; CASHEW; CHICKEN; COCONUT; CORTISONE ACETATE; COW MILK; EGG; EGGPLANT; ENGLISH WALNUT; FLAX SEED; HISTAMINE DIHYDROCHLORIDE; HYALURONIDASE; INTERFERON .GAMMA. PORCINE RECOMBINANT; KIDNEY BEAN; LAMB; LEVANT COTTON SEED; LIMULUS POLYPHEMUS; LYCOPODIUM CLAVATUM SPORE; MALUS DOMESTICA FLOWER; ONION; ORANGE; OYSTER, UNSPECIFIED; PACIFIC COD; PEANUT; PECAN; PHOSPHORUS; PORK; POTASSIUM GLUCONATE; POTATO; SALMON, UNSPECIFIED; SEROTONIN HYDROCHLORIDE; SESAME SEED; SHRIMP, UNSPECIFIED; STRYCHNOS NUX-VOMICA SEED; TOMATO; TUNA, UNSPECIFIED; WHEAT 12; 12; 12; 12; 8; 12; 12; 12; 8; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 30; 30; 30; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 6; 12; 12; 30; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0039_507fae5a-e3f9-4556-b9c6-50169e0426fc 43857-0039 HUMAN OTC DRUG Dentox Berberis vulgaris, Glycyrrhiza glabra, Lappa major, Phytolacca decandra, Stillingia sylvatica, Trifolium pratense, Lymph (suis), Medulla ossis suis, Thymus (suis), Thyroidinum (suis), Calcarea fluorica, LIQUID ORAL 20120605 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARCTIUM LAPPA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM FLUORIDE; COPPER; EUGENOL; FORMALDEHYDE; GLYCYRRHIZA GLABRA; GOLD; LIDOCAINE; MERCURIUS SOLUBILIS; MOLYBDENUM; NICKEL; PALLADIUM; PHYTOLACCA AMERICANA ROOT; SILVER; SODIUM FLUORIDE; STILLINGIA SYLVATICA ROOT; SUS SCROFA BONE MARROW; SUS SCROFA LYMPH; SUS SCROFA THYMUS; THYROID, PORCINE; TIN; TITANIUM; TRIFOLIUM PRATENSE FLOWER; ZINC 3; 3; 12; 12; 12; 12; 3; 12; 12; 12; 12; 12; 12; 3; 12; 12; 3; 8; 8; 8; 8; 12; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0040_f9bea90e-847e-4fed-8e71-e9042403ffb4 43857-0040 HUMAN PRESCRIPTION DRUG Envirotox Triticum Aestivum, Berberis Vulgaris, Lappa Major, Phytolacca Decandra, Rhamnus Cathartica, Rhamnus Purshiana, LIQUID ORAL 20130123 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACETONE; AMMONIUM CHLORIDE; ARCTIUM LAPPA ROOT; ATROPA BELLADONNA WHOLE; BERBERIS VULGARIS ROOT BARK; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PROPYLENE GLYCOL; RHAMNUS CATHARTICA FRUIT; SODIUM BENZENESULFONATE; SODIUM LAURYL SULFATE; SODIUM TRIPOLYPHOSPHATE; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; TRIFOLIUM PRATENSE FLOWER; TRITICUM AESTIVUM WHOLE; TURPENTINE OIL; ZANTHOXYLUM AMERICANUM BARK 9; 9; 3; 12; 3; 3; 6; 12; 12; 12; 3; 9; 3; 9; 9; 9; 6; 12; 6; 1; 9; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 43857-0041_abf2905c-9dac-476b-9fdc-fdb10503b059 43857-0041 HUMAN OTC DRUG ANX HP Arsenicum Album, Calcarea Carbonica, Ignatia Amara, Kali Carbonicum, Lachesis Mutus, Natrum Muriaticum LIQUID ORAL 20130124 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0042_d7285729-f6ad-40c8-b0bb-fadde441cb37 43857-0042 HUMAN OTC DRUG Sinuchron HP Arsenicum Album, Hepar Sulphuris Calcareum, Kali Bichromicum, Lycopodium Clavatum, Mercurius Solubilis LIQUID ORAL 20130125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; CALCIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0043_f5f07702-6584-43b3-9bc7-4c63adee9ebc 43857-0043 HUMAN PRESCRIPTION DRUG Serotonin Serotonin LIQUID ORAL 20130117 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SEROTONIN 6 [hp_X]/mL 43857-0044_aaf95371-ca70-440a-973d-067db4de8946 43857-0044 HUMAN OTC DRUG Sinuforce Echinacea, Hydrastis Candensis, Nux Moschata, Trigonella Foenum Graecum, Arsenicum Album, Kali Bichromicum LIQUID ORAL 20130124 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; ECHINACEA, UNSPECIFIED; FENUGREEK SEED; GOLDENSEAL; MERCURIC SULFIDE; MERCURIUS SOLUBILIS; NUTMEG; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 12; 3; 3; 3; 12; 30; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0045_d4af8372-f6d0-4382-b9ab-85deedd2eb16 43857-0045 HUMAN OTC DRUG LGB HP Belladonna, Chelidonium Majus, Colocynthis, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus LIQUID ORAL 20130123 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA WHOLE; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0046_26e3f819-4a2b-447e-8fc0-4bff3ad20159 43857-0046 HUMAN OTC DRUG Mold Mix Antigens Arsenicum Album, Phosphorus, Pulsatilla, Sepia, Mold Allersode LIQUID ORAL 20130211 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALTERNARIA ALTERNATA; ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; PHOSPHORUS; PULSATILLA VULGARIS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0047_70cc3133-9618-4046-9419-59557b034fe4 43857-0047 HUMAN OTC DRUG Chlorogenic Acid Chlorogenic acid, LIQUID ORAL 20120626 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHLOROGENIC ACID 6 [hp_X]/mL 43857-0048_9ecd62a0-116a-47cf-bb94-2a75f5655536 43857-0048 HUMAN OTC DRUG Diabenex HP Colchicum Autumnale, Lacticum Acidum, Lycopodium Clavatum, Phosphoricum Acidum, Phosphorus, Syzygium Jambolanum LIQUID ORAL 20130118 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. COLCHICUM AUTUMNALE BULB; LACTIC ACID, DL-; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0049_d6b359cf-38ac-4913-ba4b-1c3a08b25414 43857-0049 HUMAN PRESCRIPTION DRUG Chemtox Triticum Aestivum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula, Rhamnus Purshiana, Stillingia Sylvatica LIQUID ORAL 20130125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACETIC ACID; ARCTIUM LAPPA ROOT; ATROPA BELLADONNA WHOLE; BENZOIC ACID; BENZYL ALCOHOL; BERBERIS VULGARIS ROOT BARK; BORIC ACID; CHLORINE; CORTICOTROPIN; CORTISONE ACETATE; ESTRONE; EUGENOL; FRANGULA ALNUS BARK; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LEAD; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PETROLATUM; PHENYLBUTAZONE; PHOSPHORIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PORK LIVER; POTASSIUM SORBATE; RESORCINOL; SALICYLIC ACID; SORBITOL; STEARYL ALCOHOL; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; THYROID, PORCINE; TRIFOLIUM PRATENSE FLOWER; TRITICUM AESTIVUM WHOLE; XYLITOL; ZANTHOXYLUM AMERICANUM BARK 30; 3; 12; 30; 30; 3; 30; 30; 30; 30; 30; 30; 3; 3; 3; 30; 30; 30; 12; 12; 30; 30; 12; 12; 3; 8; 30; 30; 30; 30; 30; 3; 12; 8; 8; 8; 3; 1; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Pediculicide [EPC] 43857-0050_a152a313-dc54-4573-98ed-21a9b1ff6d66 43857-0050 HUMAN OTC DRUG Headache Melilotus officinalis, Spigelia anthelmia, Allium cepa, Belladonna, Bryonia, Cimicifuga racemosa, Gelsemium Sempervirens, Glonoinum LIQUID ORAL 20120718 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA ROOT; BLACK COHOSH; BRYONIA ALBA ROOT; CITHARACANTHUS SPINICRUS; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MELILOTUS OFFICINALIS TOP; NITROGLYCERIN; ONION; SANGUINARIA CANADENSIS WHOLE; SILICON DIOXIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0051_6d717ea9-8aa1-418d-835b-9b4ea8abb74a 43857-0051 HUMAN OTC DRUG V HP Arsenicum Album, Belladonna, Echinacea, Eupatorium Perfoliatum, Gelsemium Sempervirens, Lycopodium Clavatum LIQUID ORAL 20130125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0052_8cb2da99-dc2f-4435-b19e-3ba412a1275a 43857-0052 HUMAN OTC DRUG DHEA Forte Dehydroepiandrosterone (DHEA), Pregnenolone, Progesterone, LIQUID ORAL 20120807 UNAPPROVED HOMEOPATHIC BioActive Nutritionals, Inc. PRASTERONE; PREGNENOLONE; PROGESTERONE 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0053_c7376e69-e05f-4aac-9d41-061389834550 43857-0053 HUMAN OTC DRUG Lym D HP Arsenicum Album, Chelidonium Majus, Coccus Cacti, Echinacea, Hydrastis Canadensis, Lycopodium Clavatum, Lym D Nosode LIQUID ORAL 20130129 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; BORRELIA BURGDORFERI; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; NASTURTIUM OFFICINALE; PHOSPHORUS; PROTORTONIA CACTI; SUS SCROFA THYROID; TARAXACUM OFFICINALE; THYMUS SERPYLLUM; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43857-0054_4e3f9b6d-1fdc-49c8-a832-5da33d29825f 43857-0054 HUMAN OTC DRUG Virotox Echinacea, Hydrastis canadensis, Lomatium dissectum, Myrrha, Nasturtium aquaticum, Tabebuia impetiginosa, Glandula suprarenalis bovinum, Thymus (Bovine), LIQUID ORAL 20120718 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA; BOS TAURUS ADRENAL GLAND; BOS TAURUS THYMUS; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MYRRH; NASTURTIUM OFFICINALE; RANCID BEEF; RANCID BEEF; RANCID BEEF; STRYCHNOS NUX-VOMICA SEED; TABEBUIA IMPETIGINOSA BARK 12; 8; 8; 3; 12; 3; 3; 12; 3; 3; 200; 30; 60; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0055_a9e571c1-9025-4649-93e0-4fe824eeb7b1 43857-0055 HUMAN OTC DRUG Lymph II Echinacea, Phytolacca Decandra, Collinsonia Canadensis, Kali Iodatum, Pinus Sylvestris, Pix Liquida, Ferrum Phosphoricum LIQUID ORAL 20130129 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BUFO BUFO CUTANEOUS GLAND; CALCIUM SULFIDE; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; HORSE CHESTNUT; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PINE TAR; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM IODIDE; PULSATILLA VULGARIS; SILICON DIOXIDE; SODIUM CHLORIDE; STELLARIA MEDIA; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TRIBASIC CALCIUM PHOSPHATE; TURPENTINE OIL; WOOD CREOSOTE 12; 12; 12; 12; 12; 3; 3; 8; 12; 12; 12; 12; 12; 12; 3; 6; 6; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0056_d7062007-12e8-4406-93da-dc069973d25e 43857-0056 HUMAN OTC DRUG Liver Tonic II Boldo, Carduus Marianus, Curcuma Longa, Echinacea, Taraxacum Officinale, Magnesia Phosphorica, Gallbladder LIQUID ORAL 20120817 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMMI VISNAGA FRUIT; ATROPINE SULFATE; BEEF LIVER; BOS TAURUS GALLBLADDER; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PEUMUS BOLDUS LEAF; PODOPHYLLUM; SILYBUM MARIANUM SEED; TARAXACUM OFFICINALE; TURMERIC; VERONICASTRUM VIRGINICUM ROOT 12; 12; 8; 8; 12; 1; 8; 1; 12; 1; 1; 1; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0057_0c50bd77-272d-4c40-a831-f6aef65eb4d2 43857-0057 HUMAN OTC DRUG Adrenal Tonic Aralia Quinquefolia, Glycyrrhiza Glabra, Sarsaparilla, Avena Sativa, Glandula Suprarenalis Bovinum, Adrenalinum LIQUID ORAL 20130117 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMERICAN GINSENG; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BOS TAURUS ADRENAL GLAND; EPINEPHRINE; GLYCYRRHIZA GLABRA; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SMILAX REGELII ROOT; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 1; 12; 3; 8; 12; 1; 12; 12; 1; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0058_1f1b305a-0d42-4338-839a-9b257bb6d4f6 43857-0058 HUMAN OTC DRUG Allerpoll HP Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Euphrasia Officinalis, Nux Vomica, Phosphorus, Pulsatilla, Solidago Virgaurea LIQUID ORAL 20120820 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0059_0332ec4d-f2d7-4596-83f2-7a3bee4eb119 43857-0059 HUMAN OTC DRUG Occuloplex I Euphrasia Officinalis, Ginko Biloba, Hydrastis Canadensis, Taraxacum Officinale, Beta Carotene, Cyanocobalamin, Glutathione LIQUID ORAL 20130125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMMONIUM CHLORIDE; BETA CAROTENE; BOS TAURUS EYE; CALCIUM FLUORIDE; CAUSTICUM; CITRUS BIOFLAVONOIDS; CONIUM MACULATUM FLOWERING TOP; CYANOCOBALAMIN; EUPHRASIA STRICTA; GERMANIUM SESQUIOXIDE; GINKGO; GLUTATHIONE; GOLDENSEAL; MAGNESIUM CARBONATE; SELENIUM DIOXIDE; SILICON DIOXIDE; TARAXACUM OFFICINALE; UBIDECARENONE; ZINC GLUCONATE 12; 6; 8; 12; 12; 8; 12; 6; 3; 12; 3; 6; 3; 12; 12; 12; 3; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0060_17fbabc8-e9d3-4afa-8227-c6d1cc45c5ea 43857-0060 HUMAN PRESCRIPTION DRUG Menopause Angelica Archangelica, Aralia Quinquefolia, Cimicifuga Racemosa, Hydrastis Canadensis, Pulsatilla, Sabina, Sepia LIQUID ORAL 20130123 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMERICAN GINSENG; ANGELICA ARCHANGELICA ROOT; BLACK COHOSH; GOLDENSEAL; JUNIPERUS SABINA LEAFY TWIG; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SULFURIC ACID 3; 3; 3; 3; 12; 15; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0061_fd613eb0-fe99-4e76-86e2-9e77d9ccb157 43857-0061 HUMAN OTC DRUG Pre Post Surgery Hypericum Perforatum, Symphytum Officinale, Arnica Montana LIQUID ORAL 20130124 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; COMFREY ROOT; HYPERICUM PERFORATUM 200; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0062_abd53300-cfaf-483c-a0ec-405d51e4f09c 43857-0062 HUMAN OTC DRUG Scrofularoforce Juniperus Virginiana, Rumex Crispus, Scrophularia Nodosa, Xanthoxylum Fraxineum, Lymph Node, Baryta Muriatica, Belladonna LIQUID ORAL 20130125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA WHOLE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CONIUM MACULATUM FLOWERING TOP; HELLEBORUS NIGER ROOT; IODINE; JUNIPERUS VIRGINIANA TWIG; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM PHOSPHATE, DIBASIC; RUMEX CRISPUS ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SUS SCROFA LYMPH; ZANTHOXYLUM AMERICANUM BARK 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 3; 3; 12; 12; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0063_5a9f91bd-ba21-4f8c-aa71-34b26401fc60 43857-0063 HUMAN OTC DRUG Hypothalamus HP Aralia Quinqueolia, Germanium Sequioxide, Hydrocotyle Asiatica, Hypothalmus (suis), Pineal (suis), Pituitary (suis), Polygonum Multiflorum, Carcinosinum LIQUID ORAL 20120824 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMERICAN GINSENG; CENTELLA ASIATICA; FALLOPIA MULTIFLORA ROOT; GERMANIUM SESQUIOXIDE; HUMAN BREAST TUMOR CELL; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43857-0064_ff0e8265-bfbf-4231-8e0f-bea21ea9a349 43857-0064 HUMAN PRESCRIPTION DRUG Cystoges HP Berberis Vulgaris, Cantharis, Clematis Erecta, Lac Caninum, Lycopodium Clavatum, Pulsatilla, Sarsaparilla LIQUID ORAL 20121026 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BERBERIS VULGARIS ROOT BARK; CANIS LUPUS FAMILIARIS MILK; CLEMATIS RECTA FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SMILAX REGELII ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0065_9e6963b8-34c0-4ca6-bee5-2c6c149d3a84 43857-0065 HUMAN PRESCRIPTION DRUG Lymph I Echinacea, Phytolacca Decandra, Kali Iodatum, Pinus Sylvestris, Pituitary, Apis Mellifica, Aranea Diadema LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; ARANEUS DIADEMATUS; ATROPA BELLADONNA WHOLE; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; GRAPHITE; LACHESIS MUTA VENOM; MERCURIC OXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM IODIDE; SCROPHULARIA NODOSA; SULFUR; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; TOXICODENDRON PUBESCENS LEAF; VESPA CRABRO; VIROLA SEBIFERA RESIN 12; 12; 12; 12; 12; 1; 12; 12; 12; 12; 12; 12; 2; 6; 3; 12; 12; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 43857-0066_f342e11f-0167-4e6d-a15d-739833384c90 43857-0066 HUMAN OTC DRUG Thyroplex Fucus Vesiculosus, Spongia Tosta, Iodium, Liothronine Sodium, Pulsatilla, Glandula Suprarenalis Suis, Pituitary (suis), Thryodinum (suis) LIQUID ORAL 20120829 UNAPPROVED HOMEOPATHIC BioActive Nutritional FERROUS IODIDE; FUCUS VESICULOSUS; IODINE; LIOTHYRONINE SODIUM; LYCOPUS VIRGINICUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; POTASSIUM IODIDE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE 12; 3; 6; 6; 12; 12; 12; 12; 6; 3; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0067_c4016e00-666f-4c18-9f42-e158683d27c0 43857-0067 HUMAN OTC DRUG Quercetin Quercetin LIQUID ORAL 20130124 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. QUERCETIN 6 [hp_X]/mL 43857-0068_1a369be1-c4a9-4e9a-84dd-98e7c4dd57bc 43857-0068 HUMAN OTC DRUG Grain and Seed Antigens Grain and Seed Antigen, Arsenicum Album, Lycopodium Clavatum, Natrum Muriaticum, Sulphur LIQUID ORAL 20130124 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; BARLEY; BROWN RICE; CORN; COTTON SEED; FLAX SEED; LOPHATHERUM GRACILE LEAF; LYCOPODIUM CLAVATUM SPORE; MILLET; OAT; POPPY SEED; RYE; SAFFLOWER; SESAME SEED; SODIUM CHLORIDE; SORGHUM; SORGHUM BICOLOR WHOLE; SOYBEAN; SUGARCANE; SULFUR; SUNFLOWER SEED; WHEAT 12; 9; 9; 9; 9; 9; 9; 12; 9; 9; 9; 9; 9; 9; 12; 9; 9; 9; 9; 12; 9; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0069_cfbb86f8-bebd-4057-8852-191e111d0199 43857-0069 HUMAN OTC DRUG Hayfever Tonic Echinacea purpurea, Hydrastis canadensis, Eupatorium perfoliatum, Verbascum thapus, Sheep sorrel, Yellow dock, Kentucky Blue grass, Orchard grass, Red Top grass, Timothy grass, LIQUID ORAL 20130222 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACER NEGUNDO POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA FLOWERING TWIG; ALFALFA; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA; AMBROSIA ARTEMISIIFOLIA; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA OCCIDENTALIS POLLEN; CAMPHOR (NATURAL); CARYA OVATA POLLEN; DACTYLIS GLOMERATA TOP; ECHINACEA PURPUREA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; GOLD TRICHLORIDE; GOLDENSEAL; IPECAC; JUGLANS NIGRA POLLEN; ONION; PHLEUM PRATENSE TOP; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS TOP; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM DICHROMATE; QUERCUS RUBRA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS TOP; SALIX NIGRA POLLEN; SOLIDAGO VIRGAUREA FLOWERING TOP; TRIFOLIUM PRATENSE FLOWER; ULMUS AMERICANA POLLEN; VERBASCUM THAPSUS 9; 9; 12; 9; 9; 12; 9; 9; 9; 9; 12; 9; 9; 1; 1; 9; 9; 12; 1; 12; 9; 12; 9; 9; 9; 9; 12; 9; 9; 9; 9; 9; 9; 9; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0070_764d6bdf-3977-4c55-bb5d-bb4845c4cf49 43857-0070 HUMAN OTC DRUG Arnica Arnica Montana LIQUID ORAL 20121008 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA ROOT 3 [hp_X]/mL 43857-0072_012faf34-9447-4393-b303-f36913a27b9d 43857-0072 HUMAN OTC DRUG Cardiotone Adonis vernalis, Strophanthus hispidus, ATP (Adenosine Triphosphate), Cactus grandiflorus, Convallaria majalis, Cor (suis), Kali gluconicum, Magnesium glusonicum, LIQUID ORAL 20120913 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ADENOSINE TRIPHOSPHATE; ADONIS VERNALIS; CONVALLARIA MAJALIS; DIGITALIS; GERMANIUM SESQUIOXIDE; MAGNESIUM GLUCONATE; PORK HEART; POTASSIUM GLUCONATE; SELENICEREUS GRANDIFLORUS STEM; STROPHANTHUS HISPIDUS SEED; THYROID, PORCINE; UBIDECARENONE 6; 3; 6; 12; 8; 6; 6; 6; 6; 3; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0073_e845fea2-f83f-4f79-8843-f2dfaa45eb56 43857-0073 HUMAN OTC DRUG Cardio Tonic Kali Muriaticum, Kali Phosphoricum, Plantago Major, Cactus Grandiflorus, Digitalis Purpurea, Heart, L-Carnitine LIQUID ORAL 20130117 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARTEMISIA ABROTANUM FLOWERING TOP; BEEF HEART; DIGITALIS; EGG PHOSPHOLIPIDS; IODINE; LEVOCARNITINE; PLANTAGO MAJOR; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; SUS SCROFA THYROID; VALINE 12; 6; 6; 12; 12; 6; 3; 3; 3; 5; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0074_8ccb53ef-d56b-4595-a526-ee755af399ee 43857-0074 HUMAN OTC DRUG Estrogen Folliculinum, Oophorinum LIQUID ORAL 20121008 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ESTRONE; SUS SCROFA OVARY 6; 6 [hp_X]/mL; [hp_X]/mL 43857-0075_53b4deaa-4605-4823-8b7d-57bc420b87e1 43857-0075 HUMAN OTC DRUG Cough HP Arsenicum Album, Bryonia, Cuprum Aceticum, Drosera, Ipecacuanha, Kali Carbonicum, Phosphorus LIQUID ORAL 20130125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPECAC; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0076_914f1d20-e265-46d0-b006-c5aeb4d362a4 43857-0076 HUMAN OTC DRUG Shark Cartilage Shark Cartilage LIQUID ORAL 20121008 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SHARK CARTILAGE 12 [hp_X]/mL 43857-0079_5b4daf00-a7bc-4a3f-b114-cae9a2b672d2 43857-0079 HUMAN OTC DRUG Relaxoforce Humulus Lupulus, Passiflora Incarnata, Valeriana OFficinalis, Calcarea Carbonica, Coffea Tosta, Ignatia Amara LIQUID ORAL 20130123 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. COFFEA ARABICA SEED, ROASTED; HOPS; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; VALERIAN 12; 3; 12; 12; 3; 12; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0080_40ccf005-12f8-4d2e-8e9f-b305ee9aa871 43857-0080 HUMAN OTC DRUG Hydrate II Coffea Tosta, Avena Sativa, Equisetum Hyemale, Hpericum Performatum, Ginkgo Biloba, Germanium Sesquioxide LIQUID ORAL 20130218 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AVENA SATIVA FLOWERING TOP; COFFEA ARABICA SEED, ROASTED; EQUISETUM HYEMALE; GERMANIUM SESQUIOXIDE; GINKGO; HYPERICUM PERFORATUM; SILICON DIOXIDE 3; 1; 3; 8; 6; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0081_56a3b1d0-a9c8-46a5-877f-6ecf78385ac2 43857-0081 HUMAN PRESCRIPTION DRUG FNG II Echinacea, Hydrastis Canadensis, Lomatium Dissectum, Nasturtium Aquaticum, Tabebuia Impetiginosa, Iodium, Adrenalinum LIQUID ORAL 20120927 UNAPPROVED HOMEOPATHIC BioActive Nutritional CANDIDA ALBICANS; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GOLDENSEAL; IODINE; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; NASTURTIUM OFFICINALE; PHOSPHORAMIDIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILVER; SUS SCROFA THYMUS; SUS SCROFA THYROID; TABEBUIA IMPETIGINOSA BARK 12; 3; 8; 3; 6; 3; 30; 3; 12; 30; 30; 8; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 43857-0082_4dcc8047-4520-4cb3-9f19-8f7c80694998 43857-0082 HUMAN OTC DRUG Mammaryplex Echinacea, Hydrastis Canadensis, Myrrha, Phytolacca Decandra, Trigonella Foenum Graecum, Lymph, Spleen, Bryonia LIQUID ORAL 20130213 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BRYONIA ALBA ROOT; BUFO BUFO CUTANEOUS GLAND; CANIS LUPUS FAMILIARIS MILK; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; FENUGREEK SEED; GOLDENSEAL; HUMAN MAMMARY GLAND; LACHESIS MUTA VENOM; MYRRH; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; SUS SCROFA LYMPH; SUS SCROFA SPLEEN 12; 12; 12; 12; 3; 3; 3; 36; 12; 3; 3; 12; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0083_7061d986-ecca-4668-8a1f-5358644383ca 43857-0083 HUMAN OTC DRUG Bronchiforce Althaea Officinalis, Lobelia Inflata, Rheum, Verbascum Thapsus, Belladonna, Cuprum Aceticum, Drosera, Ipecacuanha LIQUID ORAL 20130213 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALTHAEA OFFICINALIS ROOT; ATROPA BELLADONNA WHOLE; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPECAC; LOBARIA PULMONARIA; LOBELIA INFLATA; RHEUM OFFICINALE ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; VERBASCUM THAPSUS 3; 12; 12; 12; 12; 12; 3; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0084_b0b7ebbc-b38a-4699-972c-79d98987efba 43857-0084 HUMAN OTC DRUG Natural Progesterone Progesterone SPRAY ORAL 20140709 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PROGESTERONE 8 [hp_X]/mL 43857-0085_1e5f5085-6563-4c50-aaaf-6d4b4ef9a212 43857-0085 HUMAN OTC DRUG Liver Tonic I Carduus Marianus, Chelidonium Majus, Taraxacum Officinale, Chionanthus Virginica, Quassia Amara, Hepar Bovine LIQUID ORAL 20130219 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BEEF LIVER; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; PHOSPHORUS; QUASSIA AMARA WOOD; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TEUCRIUM MARUM; VERONICASTRUM VIRGINICUM ROOT 8; 12; 1; 3; 12; 12; 3; 1; 12; 12; 1; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0086_7478508c-7e0c-4efa-a8d7-968d55047eb0 43857-0086 HUMAN OTC DRUG Melatonin Melatonin LIQUID ORAL 20130213 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. MELATONIN 6 [hp_X]/mL 43857-0087_147dda1b-13da-49f6-9c4c-c75a4360209a 43857-0087 HUMAN OTC DRUG Bio Myelin Protein Brain (bovine), SPRAY ORAL 20121108 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BOS TAURUS BRAIN 6 [hp_X]/mL 43857-0088_5caddb3a-50d5-473a-90ff-51143f06c841 43857-0088 HUMAN OTC DRUG Bio Iodine Colloidal Iodine LIQUID ORAL 20130213 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. IODINE 6 [hp_X]/mL 43857-0089_782e92d5-7016-4004-b19e-c786818eba84 43857-0089 HUMAN PRESCRIPTION DRUG Vermex Artemisia Vulgaris, Cina, Filix Mas, Spigelia Anthelmia, Teucrium Marum, Calcarea Carbonica, Graphites LIQUID ORAL 20120927 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARTEMISIA CINA PRE-FLOWERING TOP; ARTEMISIA VULGARIS ROOT; ASCARIS LUMBRICOIDES; DRYOPTERIS FILIX-MAS ROOT; GRAPHITE; MERCURIC CHLORIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA; TAENIA SOLIUM; TANACETUM VULGARE TOP; TEUCRIUM MARUM 3; 3; 30; 3; 12; 12; 12; 12; 12; 3; 30; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0090_789e31cc-d0d2-494d-9c91-4f5d63ecba66 43857-0090 HUMAN OTC DRUG Stomaplex Carduus Marianus, Gentiana Lutea, Sambucus Nigra, Senna, Stomach, Arsenicum Album, Atropinum Sulphuricum LIQUID ORAL 20130219 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; ATROPINE SULFATE; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP; SENNA LEAF; SILYBUM MARIANUM SEED; STRYCHNOS NUX-VOMICA SEED; TRIPE 12; 12; 12; 3; 12; 12; 3; 3; 3; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0093_a90eb86d-b9e5-466e-ac11-c0878d09f4db 43857-0093 HUMAN OTC DRUG Dentaforce Antimonium Crudum, Belladonna, Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Hekla Lava, Mercurius Solubilis LIQUID ORAL 20130910 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANTIMONY TRISULFIDE; ATROPA BELLADONNA; CALCIUM FLUORIDE; HEKLA LAVA; HYDROFLUORIC ACID; LEAD; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0094_628ed022-5a24-48a8-82bf-05207f72b4d9 43857-0094 HUMAN OTC DRUG Apizelen Alfalfa, Avena sativa, Chelidonium majus, Aralia quinquefolia, Beta vulgaris, Calendula officinalis, Cuprum aceticum, Echinacea, natrum muriaticum, Oxalis acetosella Paloondo, LIQUID ORAL 20121109 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALFALFA; AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; BETA VULGARIS; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; COBALTOUS ACETATE; COBALTOUS GLUCONATE; COPPER GLUCONATE; CUPRIC ACETATE; ECHINACEA ANGUSTIFOLIA; GERMANIUM; GLUTATHIONE; LARREA TRIDENTATA TOP; MAGNESIUM GLUCONATE; OXALIS MONTANA LEAF; PHYTOLACCA AMERICANA ROOT; REISHI; SILVER; SODIUM CHLORIDE; TRIFOLIUM PRATENSE FLOWER; UBIDECARENONE; URTICA DIOICA; VISCUM ALBUM FRUITING TOP 1; 2; 1; 2; 2; 1; 3; 3; 3; 2; 2; 6; 3; 2; 3; 2; 2; 4; 6; 2; 2; 3; 2; 2 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43857-0095_deed1164-ef09-4768-8cea-b6c906662c12 43857-0095 HUMAN OTC DRUG Serotonin Serotonin LIQUID ORAL 20130219 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SEROTONIN 6 [hp_X]/mL 43857-0096_d45dbfb4-4ee2-4606-afb0-e4804c14bffb 43857-0096 HUMAN OTC DRUG HZ Formula Baptisia Tinctoria, Echinacea, Lomatium Dissectum, Tabebuia Impetiginosa, Propolis, Spleen, Thymus, Thyroidinum LIQUID ORAL 20130213 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BAPTISIA TINCTORIA ROOT; CANDIDA ALBICANS; CHLAMYDIA TRACHOMATIS; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN PAPILLOMAVIRUS; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; PROPOLIS WAX; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; SUS SCROFA THYROID; TABEBUIA IMPETIGINOSA BARK; TRICHINELLA SPIRALIS 3; 30; 30; 3; 12; 30; 30; 30; 3; 12; 6; 12; 6; 6; 6; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0097_e8f28c09-8615-42e0-9747-9c815bdae4b5 43857-0097 HUMAN OTC DRUG Anxiety II Aconitum napellus, Arsenicum album, Belladonna, Calcarea carbonica, Carcinosin, Causticum, Gelsemium sempervirens, Lachesis mutus, Mercurius vivus, SPRAY ORAL 20121109 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CAUSTICUM; GELSEMIUM SEMPERVIRENS ROOT; HUMAN BREAST TUMOR CELL; LACHESIS MUTA VENOM; MERCURY; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43857-0099_e5367f94-4ddf-4416-ba32-253888ca28f4 43857-0099 HUMAN OTC DRUG ASP Echinacea, Hydrastis Canadensis, Tabeuia Impetiginosa, Glandula Suprarenalis Suis, Thymus, Thyroidinum, LIQUID ORAL 20121112 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANAMIRTA COCCULUS SEED; ARSENIC TRIOXIDE; ASPERGILLUS FLAVUS; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LEDUM PALUSTRE TWIG; MERCURIC CYANIDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; THYROID, PORCINE 12; 12; 30; 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 8; 8; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0100_7545ec5c-ea96-4da4-83da-16ecaeb0afe5 43857-0100 HUMAN OTC DRUG Pneumoforce Althaea Officinalis, Natrum Carbonicum Rheum Officinale, Verbascum Thapsus, Zingiber Officinale, Aconitum Napellus LIQUID ORAL 20130212 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACONITUM NAPELLUS; ALTHAEA OFFICINALIS ROOT; DROSERA ROTUNDIFOLIA; GINGER; LOBELIA INFLATA; PHOSPHORUS; POTASSIUM DICHROMATE; RHEUM OFFICINALE ROOT; SODIUM CARBONATE; VERBASCUM THAPSUS 12; 3; 12; 3; 12; 12; 12; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0101_2749507b-bad0-47b3-b76d-689c4d6b3066 43857-0101 HUMAN OTC DRUG FNG I Echinacea, Hydrastis Canadensis, Lomatium Dissectum, Nasturtium Aquaticum, Tabebuia Impetiginosa, Condurango LIQUID ORAL 20130212 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; ASTRAGALUS PROPINQUUS ROOT; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BOS TAURUS ADRENAL GLAND; BOS TAURUS THYMUS; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA, UNSPECIFIED; GINKGO; GOLDENSEAL; LIGUSTICUM PORTERI ROOT; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MARSDENIA CONDURANGO BARK; MUCOR RACEMOSUS; NASTURTIUM OFFICINALE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PROPOLIS WAX; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; TABEBUIA IMPETIGINOSA BARK 12; 12; 6; 12; 8; 8; 12; 12; 3; 4; 3; 4; 3; 12; 4; 12; 3; 12; 12; 6; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0102_0533349b-d6d8-480f-b348-526a8cf98c9b 43857-0102 HUMAN PRESCRIPTION DRUG Androbalance Androstenedione, Dehydroepiandrosterone, Pregnenolone, Progesterone, Testosterone LIQUID ORAL 20121026 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. 7-OXO-PRASTERONE; ANDROSTENEDIONE; PREGNENOLONE; PROGESTERONE; TESTOSTERONE 6; 6; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Progesterone [Chemical/Ingredient],Progesterone [EPC],Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 43857-0103_2678d57b-f93d-4bb1-b254-5076233af33d 43857-0103 HUMAN OTC DRUG Progesterone Progesterone LIQUID ORAL 20130212 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PROGESTERONE 6 [hp_X]/mL 43857-0104_ce548e72-76b8-423b-b9b1-373c634efcfb 43857-0104 HUMAN OTC DRUG Pancreaplex Chelidonium Majus, Glycyrrhiza Glabra, Hydrastis Canadensis, Nux Moschata, Rheum Officinale, Syzygium Jambolanum LIQUID ORAL 20121228 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHELIDONIUM MAJUS; GINGER; GLYCYRRHIZA GLABRA; GOLDENSEAL; KIDNEY BEAN; NUTMEG; PHOSPHORIC ACID; PHOSPHORUS; PORK LIVER; RHEUM OFFICINALE ROOT; SUS SCROFA ADRENAL GLAND; SUS SCROFA PANCREAS; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; SYZYGIUM CUMINI SEED; TARAXACUM OFFICINALE 3; 3; 3; 3; 12; 3; 12; 12; 6; 3; 6; 6; 6; 8; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0105_7df89371-9138-4f48-9084-067ddb992537 43857-0105 HUMAN OTC DRUG Cardiofroce II Abrotanum, Boldo, Chelidonium Majus, Cimicifuga Racemosa, Convallaria Majalis, Kali Phosphoricum, Taraxacum Officinale LIQUID ORAL 20130212 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARTEMISIA ABROTANUM FLOWERING TOP; BLACK COHOSH; CHELIDONIUM MAJUS; CONVALLARIA MAJALIS; MAGNESIUM SULFATE HEPTAHYDRATE; NERIUM OLEANDER LEAF; PEUMUS BOLDUS LEAF; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; TARAXACUM OFFICINALE 3; 3; 3; 3; 5; 8; 3; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0106_82ac5956-a4b6-4545-906c-c9c0a947f165 43857-0106 HUMAN OTC DRUG Inflammation I Echinacea, Hydrastis Canadensis, Nasturtium Aquaticum, Phytolacca Decandra, Apis Mellifica, Belladonna LIQUID ORAL 20130212 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; ATROPA BELLADONNA WHOLE; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; GOLDENSEAL; NASTURTIUM OFFICINALE; NERIUM OLEANDER LEAF; NITRIC ACID; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE 12; 12; 3; 12; 3; 3; 12; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0107_fe2c598b-a61c-4c7b-8a9c-e2edbddd41c3 43857-0107 HUMAN PRESCRIPTION DRUG Liver Tonic III Carduus Marianus, Chelidonium Majus, Taraxacum Officinale, Chionanthus Virginica, Quassia Amara, Hepar Sulphuris Calcareum LIQUID ORAL 20121226 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BEEF LIVER; CALCIUM SULFIDE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; HEPATITIS A VIRUS; HEPATITIS B VIRUS; HEPATITIS C VIRUS; MILK THISTLE; PHOSPHORUS; QUASSIA AMARA WOOD; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TEUCRIUM MARUM; VERONICASTRUM VIRGINICUM ROOT 8; 8; 12; 1; 3; 12; 30; 30; 30; 1; 12; 3; 12; 12; 1; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 43857-0108_bf5e9764-9e14-449b-bb9b-468e33bd4400 43857-0108 HUMAN OTC DRUG Bio Res Q Rescue LIQUID ORAL 20130212 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0109_edbd427d-cd58-405e-92a9-38c053985b3a 43857-0109 HUMAN OTC DRUG Viscumforce Passiflora Incarnata, Valeriana Officinalis, Aurum Metallicum, Baryta Carbonica, Glonoinum, Phosphorus LIQUID ORAL 20130211 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BARIUM CARBONATE; GOLD; LEAD; NITROGLYCERIN; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; VALERIAN; VISCUM ALBUM FRUITING TOP 12; 12; 12; 12; 3; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0110_755ac59e-da99-4926-a341-5e72c7d35300 43857-0110 HUMAN OTC DRUG Hepataplex Beta Vulgaris, Boldo, Carduus Marianus, Chelidonium Majus, Peteroselinum Sativum, Taraxacum Officinale LIQUID ORAL 20130211 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BETA VULGARIS; CHELIDONIUM MAJUS; GLUTATHIONE; LYCOPODIUM CLAVATUM SPORE; PETROSELINUM CRISPUM; PEUMUS BOLDUS LEAF; PHOSPHORUS; PORK LIVER; SILYBUM MARIANUM SEED; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 3; 3; 6; 12; 3; 3; 12; 6; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0111_caed96fc-ec79-4d72-8450-b46aba5f0830 43857-0111 HUMAN OTC DRUG Coxsackie Coxsackie B1, B4 LIQUID ORAL 20121009 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4 200; 200 [hp_C]/mL; [hp_C]/mL 43857-0112_19623dde-d190-44b9-a2e1-dee60c249bbd 43857-0112 HUMAN OTC DRUG Adaptagen Aralia Quinquefolia, Avena Sativa, Capsicum Annuum, Ginkgo Biloba, Glycyrrhiza Glabra, Hydrocotyle Asiatica LIQUID ORAL 20130208 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ADENOSINE TRIPHOSPHATE; AMERICAN GINSENG; ASCORBIC ACID; AVENA SATIVA FLOWERING TOP; CAPSICUM; CENTELLA ASIATICA; COPPER GLUCONATE; GINKGO; GLYCYRRHIZA GLABRA; IODINE; LEDUM PALUSTRE TWIG; MOLYBDENUM; PHOSPHORIC ACID; PICRIC ACID; RIBOFLAVIN; SELENIUM; SEPIA OFFICINALIS JUICE; SODIUM CARBONATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYROID; THIAMINE HYDROCHLORIDE; VANADIUM 30; 3; 6; 3; 3; 3; 12; 3; 3; 12; 12; 12; 12; 12; 6; 12; 12; 12; 8; 8; 8; 4; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0113_ae7f4d21-de97-4d88-acfa-500340edd1e5 43857-0113 HUMAN OTC DRUG Venoforce I Aesculus Hippocastanum, Collinsonia Canadensis, Echinacea, Hamamelis Virginiana, Pulsatilla, Arnica Montana LIQUID ORAL 20130208 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACTIVATED CHARCOAL; ARNICA MONTANA; COLLINSONIA CANADENSIS ROOT; ECHINACEA, UNSPECIFIED; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROFLUORIC ACID; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PAEONIA OFFICINALIS ROOT; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED 12; 12; 3; 3; 12; 3; 3; 12; 12; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0114_27e12e31-becc-4a07-9339-e1896010e7ff 43857-0114 HUMAN OTC DRUG Adrenoplex Chelidonium Majus, Echinacea, Glandula Suprarenalis Bovinum, Spleen, Carduus Marianus, Lycopodium Clavatum LIQUID ORAL 20130208 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BOS TAURUS ADRENAL GLAND; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SILYBUM MARIANUM SEED; SODIUM CHLORIDE; SUS SCROFA SPLEEN 8; 3; 3; 12; 12; 12; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0115_cf6b7953-e9cf-409f-ba36-7eabf07028f4 43857-0115 HUMAN OTC DRUG Bone Repair HP Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Fluoricum Acidum, Hekla Lava, Rhus Toxicodendron LIQUID ORAL 20130130 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CALCIUM FLUORIDE; COMFREY ROOT; HEKLA LAVA; HYDROFLUORIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0116_4e6dfa17-970d-4d69-b352-6a8e212dc6ed 43857-0116 HUMAN OTC DRUG Kidney Tonic I Echinacea, Petroselinum Sativum, Solidago Virgaurea, Uva-Ursi, Pareira Brava, Glutathione, Kidney LIQUID ORAL 20121217 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARCTOSTAPHYLOS UVA-URSI LEAF; CHONDRODENDRON TOMENTOSUM ROOT; ECHINACEA ANGUSTIFOLIA; GLUTATHIONE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PETROSELINUM CRISPUM; PORK KIDNEY; SOLIDAGO VIRGAUREA FLOWERING TOP 1; 3; 1; 6; 12; 12; 1; 8; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0117_09ad5694-6b7b-4b1e-a46a-b84d2f6196a2 43857-0117 HUMAN OTC DRUG Bio Cherry Plum Cherry Plum LIQUID ORAL 20130130 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PRUNUS CERASIFERA FLOWER 6 [hp_X]/mL 43857-0118_b5d4e0c2-e36d-4720-83ac-45bb0786e814 43857-0118 HUMAN PRESCRIPTION DRUG Bio Oak Oak LIQUID ORAL 20130130 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. QUERCUS ALBA BARK 6 [hp_X]/mL 43857-0119_6e27078b-f276-403b-ae69-80ac0d76c27f 43857-0119 HUMAN OTC DRUG Spleen Spleen LIQUID ORAL 20121008 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BOS TAURUS SPLEEN 6 [hp_X]/mL 43857-0120_6a7865ab-f8a6-43c0-a372-769a191fdd86 43857-0120 HUMAN OTC DRUG Progesterone Progesterone LIQUID ORAL 20121009 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PROGESTERONE 6 [hp_X]/mL 43857-0121_0c6a95f8-f68c-406c-9a65-5bec5b1965d6 43857-0121 HUMAN OTC DRUG Bio Electrolyte Boricum Gluconicum, Calcarea Gluconica, Chromium Gluconicum, Cobaltum Gluconicum, Cuprum Gluconicum LIQUID ORAL 20130129 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BORON GLUCONATE; CALCIUM GLUCONATE; CHROMIUM GLUCONATE; COBALTOUS GLUCONATE; COPPER GLUCONATE; FERROUS GLUCONATE; MAGNESIUM GLUCONATE; MANGANESE GLUCONATE; NICKEL GLUCONATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM DIOXIDE; SODIUM GLUCONATE; TRIBASIC CALCIUM PHOSPHATE; VANADIUM; ZINC GLUCONATE 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 6; 6; 9; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0122_38305ca4-1e14-4279-8613-f46a557cf141 43857-0122 HUMAN OTC DRUG Osteoforce Bone, Calcarea Carbonica, Calcarea Fluorica, Causticum, Cocculus Indicus, Ledum Palustre, Phosphoricum Acidum, Rhus Toxicodendron LIQUID ORAL 20130125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANAMIRTA COCCULUS SEED; CAUSTICUM; LEDUM PALUSTRE TWIG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; SUS SCROFA BONE; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0123_e797e8aa-20f4-4b07-9bc6-ac59afd9baa6 43857-0123 HUMAN OTC DRUG Gaba Gaba LIQUID ORAL 20130108 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. .GAMMA.-AMINOBUTYRIC ACID 6 [hp_X]/mL 43857-0126_f7574d19-4616-4152-9d2a-d9cca2efc8a5 43857-0126 HUMAN OTC DRUG Histamine Histaminum Hydrochloricum LIQUID ORAL 20130307 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HISTAMINE DIHYDROCHLORIDE 6 [hp_X]/mL 43857-0127_1d4d7740-19fc-42ae-9f7f-b3eccafbd75b 43857-0127 HUMAN OTC DRUG Anti Hive Ammonium Carbonicum, Apis Mellifica, Argentum Metallicum, Arsenicum Album, Dulcamara, Mezereum LIQUID ORAL 20130307 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMMONIUM CARBONATE; APIS MELLIFERA; ARSENIC TRIOXIDE; DAPHNE MEZEREUM BARK; SILVER; SOLANUM DULCAMARA TOP; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0128_55b17f16-725e-4631-8228-9662f9c4ce0a 43857-0128 HUMAN OTC DRUG Arrythmiaforce Convallaria Majalis, Juglans Nigra, Leonurus Cardiaca, Adonis Vernalis, Magnesia Sulphurica, Kali Chloricum LIQUID ORAL 20130307 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ADONIS VERNALIS; BLACK WALNUT; CONVALLARIA MAJALIS; DIGITALIS; IBERIS AMARA SEED; LEONURUS CARDIACA; LYCOPUS VIRGINICUS; MAGNESIUM SULFATE HEPTAHYDRATE; PHOSPHORUS; POTASSIUM CHLORATE 4; 3; 3; 12; 6; 3; 12; 4; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0129_8455abbf-1b18-491d-87c1-4e2431cba3a3 43857-0129 HUMAN OTC DRUG Bio Impatiens Impatiens LIQUID ORAL 20130311 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. IMPATIENS GLANDULIFERA FLOWER 6 [hp_X]/mL 43857-0130_41adf7b2-00fc-4b68-ae46-a9f72d1baacd 43857-0130 HUMAN OTC DRUG Glutathione Glutathione LIQUID ORAL 20130228 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. GLUTATHIONE 6 [hp_X]/mL 43857-0131_2d111987-d1b0-447f-bf69-bd8a4ffa9ee9 43857-0131 HUMAN OTC DRUG Arthritis HP Apis Mellifica, Bryonia, Causticum, Colchicum Autumnale, Kalmia Latifolia, Ledum Palustre LIQUID ORAL 20130220 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; BRYONIA ALBA ROOT; CAUSTICUM; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0132_bb1f8aed-780f-476b-82b3-b26531929128 43857-0132 HUMAN OTC DRUG Pneumotox Triticum Aestivum, Alfalfa, Arnica Montana, Asclepias Tuberosa, Chamomilla, Echinacea, Eucalyptus Globulus, Fucus Vesiculosus, Hordeum Vulgare LIQUID ORAL 20130924 UNAPPROVED HOMEOPATHIC BioActive Nutritional 2,5-DIAMINOTOLUENE SULFATE; ACETONE; ALFALFA; AMMONIUM CHLORIDE; AMMONIUM THIOGLYCOLATE; ANHYDROUS CITRIC ACID; ANTHRAQUINONE; ARNICA MONTANA; ARSENIC TRIOXIDE; ASCLEPIAS TUBEROSA FLOWERING TOP; BROWN RICE; COMFREY ROOT; DIMETHICONE; ECHINACEA, UNSPECIFIED; ETHANOLAMINE; ETHYLENE GLYCOL; EUCALYPTUS GLOBULUS LEAF; FENUGREEK SEED; FUCUS VESICULOSUS; GLUTARAL; GLYCOLIC ACID; HORDEUM VULGARE TOP; HYDROGEN PEROXIDE; LAMINARIA DIGITATA; MATRICARIA RECUTITA; METHYL METHACRYLATE; NASTURTIUM AQUATICUM; NITRIC ACID; OENANTHE AQUATICA FRUIT; P-AMINOPHENOL; PALMITIC ACID; PARAFFIN; PHOSPHORIC ACID; PHOSPHORUS; PLANTAGO MAJOR; PROPYL ALCOHOL; PROPYLENE GLYCOL; PULSATILLA VULGARIS; RAPHANUS SATIVUS; SILICON DIOXIDE; SODIUM BENZENESULFONATE; SODIUM CARBONATE; SODIUM CHLORIDE; SODIUM LAURYL SULFATE; SODIUM POLYACRYLATE (8000 MW); SODIUM TRIPOLYPHOSPHATE; SUS SCROFA LUNG; TARTARIC ACID; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; TRITICUM AESTIVUM WHOLE; TURPENTINE OIL 30; 9; 3; 9; 30; 30; 30; 3; 12; 3; 8; 3; 30; 3; 30; 30; 3; 3; 3; 30; 30; 3; 30; 3; 3; 30; 3; 12; 12; 30; 30; 30; 12; 12; 3; 30; 9; 12; 3; 8; 9; 30; 12; 9; 30; 9; 8; 30; 12; 3; 1; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0133_bcd62448-3b5b-4de1-b678-4f3925a85926 43857-0133 HUMAN OTC DRUG Lymphoplex Myrrha, Trigonella Foenum Graecum, Pinus Sylvestris, Lymph, Spleen, Conium Maculatum, Echinacea LIQUID ORAL 20130117 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; FENUGREEK SEED; HYDRANGEA ARBORESCENS ROOT; MYRRH; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; SILICON DIOXIDE; SUS SCROFA LYMPH; SUS SCROFA SPLEEN 12; 12; 12; 3; 12; 3; 12; 6; 12; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0134_3919bd3e-ac89-44c1-bdfa-68555f47ef36 43857-0134 HUMAN OTC DRUG Bio Mimulus Mimulus LIQUID ORAL 20130311 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. MIMULUS GUTTATUS FLOWERING TOP 6 [hp_X]/mL 43857-0135_d0e3a6ad-be19-416d-8c91-2707e20dc460 43857-0135 HUMAN OTC DRUG Vax Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Tabebuia Impetiginosa, Trifolium Pratense, Arnica Montana LIQUID ORAL 20130114 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANTIMONY TRISULFIDE; ARNICA MONTANA; ARSENIC TRIOXIDE; ASTRAGALUS PROPINQUUS ROOT; ATROPA BELLADONNA WHOLE; BAPTISIA TINCTORIA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; DIPHENYLTRICHLOROETHANE; ECHINACEA, UNSPECIFIED; FENUGREEK SEED; GOLDENSEAL; LIGUSTICUM PORTERI ROOT; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; PROPOLIS WAX; SILICON DIOXIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; TARAXACUM OFFICINALE; THIMEROSAL; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA; VERONICASTRUM VIRGINICUM ROOT 30; 4; 12; 6; 12; 3; 4; 4; 30; 3; 4; 3; 4; 4; 12; 12; 4; 4; 4; 6; 30; 8; 8; 3; 4; 30; 30; 12; 3; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0136_2c4c7994-6a17-4764-ba9e-b175f7894558 43857-0136 HUMAN OTC DRUG Nephroplex Berberis Vulgaris, Hydrangea Arborescens, Petroselinum Sativum, Solidago Virgaurea, Uva Ursi, Rubia Tinctorum LIQUID ORAL 20130114 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; EUTROCHIUM PURPUREUM ROOT; GLUTATHIONE; HYDRANGEA ARBORESCENS ROOT; MERCURIC CHLORIDE; PETROSELINUM CRISPUM; PORK KIDNEY; RUBIA TINCTORUM ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 3; 3; 12; 12; 6; 3; 12; 3; 6; 5; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0137_05dff914-0691-4fc0-9686-5e9e82116fd5 43857-0137 HUMAN OTC DRUG Prostatone Echinacea, Hydrastis Canadensis, Phytolacca Decandra, Sabal Serrulata, Sarsaparilla, Solidago Virgaurea LIQUID ORAL 20130227 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CLEMATIS RECTA FLOWERING TOP; ECHINACEA, UNSPECIFIED; GOLDENSEAL; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SAW PALMETTO; SMILAX REGELII ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA PROSTATE; SUS SCROFA TESTICLE; ZINC SULFATE HEPTAHYDRATE 12; 3; 3; 12; 3; 12; 3; 3; 3; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0138_f2973d1d-4dd9-46af-8d3d-225c912193c0 43857-0138 HUMAN OTC DRUG Acetylcholine Chloride Acetylcholine Chloride LIQUID ORAL 20130228 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACETYLCHOLINE CHLORIDE 6 [hp_X]/mL 43857-0139_0cf98588-e413-4285-8ccc-c905cab0f7a0 43857-0139 HUMAN OTC DRUG Rheumaforce Chondrus Crispus, Cimicifuga Racemosa, Spiraea Ulmaria, Symphytum Officinale, Trifolium Pratense, Urtica Urens LIQUID ORAL 20130114 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BLACK COHOSH; CHONDRUS CRISPUS; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; FILIPENDULA ULMARIA ROOT; FORMICA RUFA; LITHIUM CARBONATE; RHODODENDRON AUREUM LEAF; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; URTICA URENS; ZANTHOXYLUM AMERICANUM BARK 3; 3; 12; 3; 12; 3; 12; 12; 12; 12; 12; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0140_8ca90d75-d5e4-45d2-b0c9-4fdebba3de6f 43857-0140 HUMAN OTC DRUG Bio Chicory Chicory LIQUID ORAL 20130228 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHICORY ROOT 6 [hp_X]/mL 43857-0141_f5c04e3b-1949-4e7d-98cb-3fabbb66fa52 43857-0141 HUMAN OTC DRUG Occuloplex G Euphrasia Officinalis, Ginkgo Biloba, Petroselinum Sativum, Spigelia Anthelmia, Vaccinium Myrtillus, Ascorbic Acidum, Eye LIQUID ORAL 20130116 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ASCORBIC ACID; BILBERRY; BRYONIA ALBA ROOT; CALCIUM SULFIDE; EUPHRASIA STRICTA; GERMANIUM SESQUIOXIDE; GINKGO; GOLD; LITHIUM; PETROSELINUM CRISPUM; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP OIL; SPIGELIA ANTHELMIA; SULFUR; SUS SCROFA EYE; UBIDECARENONE 6; 3; 12; 12; 3; 8; 3; 12; 8; 3; 12; 12; 3; 12; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0142_90302789-423d-43cc-bac9-81039219c641 43857-0142 HUMAN OTC DRUG Insomnia HP Arsenicum Album, Coffea Cruda, Kali Carbonicum, Magnesia Carbonica, Nux Vomica, Passiflora Incarnata, Sepia LIQUID ORAL 20130409 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; MAGNESIUM CARBONATE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0143_7256c616-0a78-4281-b531-36956c6f2651 43857-0143 HUMAN OTC DRUG Lipotox Squalene, Cholesterinum, Estrogen, Progesterone, Aspartame, Benzalkonium chloride, Formalinum, Methylene chloride LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACETIC ACID; ARSENIC ACID; ASPARTAME; BENZALKONIUM CHLORIDE; BENZOIC ACID; BENZYL ALCOHOL; BORIC ACID; CHLORINE; CHOLESTEROL; CORTICOTROPIN; CORTISONE ACETATE; ESTRADIOL; ESTRIOL; ESTRONE; EUGENOL; FORMALDEHYDE; ISOPROPYL PALMITATE; LACTIC ACID; LEAD; LYCOPODIUM CLAVATUM SPORE; METHYLENE CHLORIDE; METHYLPARABEN; PETROLATUM; PHENYLBUTAZONE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM SORBATE; PROGESTERONE; PROPYLPARABEN; RESORCINOL; SALICYLIC ACID; SODIUM BENZOATE; SODIUM CITRATE; SORBITOL; SQUALENE; STEARYL ALCOHOL; STRYCHNOS NUX-VOMICA SEED; TITANIUM DIOXIDE; XYLITOL; ZINC OXIDE 30; 30; 30; 30; 30; 30; 30; 30; 12; 30; 30; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 12; 30; 30; 30; 30; 30; 30; 8; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0144_d9670f93-960b-49e9-ab5f-3153fe8096d2 43857-0144 HUMAN OTC DRUG Edemaforce Cactus Grandiflorus, Calendula Officinalis, Convallaria Majalis, Dulcamara, Leptandra Virginica, Solidago Virgaurea LIQUID ORAL 20130315 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; CONVALLARIA MAJALIS; LEAD; LYCOPODIUM CLAVATUM SPORE; SAMBUCUS NIGRA FLOWERING TOP; SELENICEREUS GRANDIFLORUS STEM; SOLANUM DULCAMARA TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; VERONICASTRUM VIRGINICUM ROOT 12; 12; 12; 12; 3; 12; 3; 12; 12; 12; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0145_9ea58fbe-bac8-4c73-a111-e06c797ab643 43857-0145 HUMAN OTC DRUG Allergen II Kali Gluconicum, Adrenalinum, Hepar, Pollen Allersode, Arsenicum Album, Phosphorus, Pulsatilla LIQUID ORAL 20120222 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACER NEGUNDO POLLEN; AGROSTIS GIGANTEA POLLEN; ALFALFA; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ARSENIC TRIOXIDE; BEEF LIVER; BETULA OCCIDENTALIS POLLEN; CARYA OVATA POLLEN; DACTYLIS GLOMERATA TOP; EPINEPHRINE; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; HISTAMINE DIHYDROCHLORIDE; JUGLANS NIGRA POLLEN; PHLEUM PRATENSE TOP; PHOSPHORUS; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS TOP; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM GLUCONATE; PULSATILLA VULGARIS; QUERCUS RUBRA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS TOP; SALIX NIGRA POLLEN; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; TRIFOLIUM PRATENSE FLOWER; ULMUS AMERICANA POLLEN 9; 9; 9; 9; 9; 9; 9; 12; 8; 9; 9; 9; 8; 9; 9; 30; 9; 9; 12; 9; 9; 9; 6; 12; 9; 9; 9; 9; 9; 12; 9; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0146_fd1e70e9-c9ff-4183-bef1-8b03dbbee654 43857-0146 HUMAN OTC DRUG Weed and Grass Antigen Alfalfa, Amaranth, Coclebur, Tarasacum officinale, Solidago viragaurea, Kentycky blue grass, Lambs quarter, Marsh elder, Meaadow fescue, LIQUID ORAL 20130308 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AGRIMONIA EUPATORIA; AGROSTIS GIGANTEA TOP; ALFALFA; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ANTHOXANTHUM ODORATUM; ARSENIC TRIOXIDE; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS ROOT; CHENOPODIUM ALBUM WHOLE; DACTYLIS GLOMERATA TOP; FESTUCA PRATENSIS TOP; IVA ANNUA POLLEN; LOLIUM PERENNE POLLEN; ONION; PHLEUM PRATENSE TOP; POA PRATENSIS TOP; PULSATILLA VULGARIS; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; TRIFOLIUM REPENS FLOWER 9; 9; 9; 9; 9; 9; 9; 9; 12; 9; 9; 9; 9; 9; 9; 9; 12; 9; 9; 12; 9; 9; 9; 12; 9; 9; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0147_20c857e1-9559-4d65-b5c0-2048f8abf78d 43857-0147 HUMAN OTC DRUG Pancreaforce Juniperus Virginiana, Lappa Major, Rhamnus Purshiana, Syzygium Jambolanum, Chelidonium Majus, Lycopodium Clavatum LIQUID ORAL 20130409 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARCTIUM LAPPA ROOT; CHELIDONIUM MAJUS; CITHARACANTHUS SPINICRUS; FRANGULA PURSHIANA BARK; JUNIPERUS VIRGINIANA OIL; LYCOPODIUM CLAVATUM SPORE; MYRTUS COMMUNIS TOP; PHOSPHORIC ACID; PHOSPHORUS; SODIUM SULFATE; SYZYGIUM CUMINI SEED 3; 12; 12; 3; 3; 12; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0148_ceba0d31-a2eb-4f04-81fe-612a7e4685f1 43857-0148 HUMAN OTC DRUG Diathesis III Cor, Small Intestine, Germanium Sesquioxide, Cobaltum Metallicum, Cysteinum, Manganum Metallicum, Manganum Gluconicum LIQUID ORAL 20130416 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. .ALPHA.-KETOGLUTARIC ACID; ARSENIC TRIOXIDE; COBALT; CYSTEINE; FUMARIC ACID; GERMANIUM SESQUIOXIDE; GOLD; MANGANESE; MANGANESE GLUCONATE; PHOSPHORUS; PORK HEART; PORK INTESTINE; SODIUM DIETHYL OXALACETATE 12; 12; 9; 9; 12; 8; 12; 9; 10; 12; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0149_da7a1818-6ba7-43aa-8e37-8ff38c32bc64 43857-0149 HUMAN OTC DRUG Gaba 6X Gaba LIQUID ORAL 20130910 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. .GAMMA.-AMINOBUTYRIC ACID 6 [hp_X]/mL 43857-0150_5655e918-0dde-4750-9e9a-c97d418aab2a 43857-0150 HUMAN OTC DRUG Estrogen Folliculinum, Oophorinum LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ESTRONE; SUS SCROFA OVARY 6; 6 [hp_X]/mL; [hp_X]/mL 43857-0151_b2be6849-2053-426b-abb2-8e4918dd3b57 43857-0151 HUMAN OTC DRUG Naja Forte X Naja Tripudians LIQUID ORAL 20130403 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. NAJA NAJA VENOM 9 [hp_X]/mL 43857-0152_5b689fd7-ff37-49ae-90d0-30d9a06ec401 43857-0152 HUMAN OTC DRUG HZ HP Lycopodium Clavatum, Natrum Muriaticum, Nitricum Acidum, Ranunculus Bulbosus, Rhus Toxicodendron LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0154_467308dd-88e9-4243-8001-1c79fc302a6c 43857-0154 HUMAN OTC DRUG Influaforce NOT APPLICABLE LIQUID ORAL 20140918 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); IPECAC; LOMATIUM DISSECTUM ROOT; MERCURIC CHLORIDE; MYRRH; NASTURTIUM OFFICINALE; PROPOLIS WAX; RANCID BEEF; TABEBUIA IMPETIGINOSA BARK 12; 3; 12; 12; 12; 3; 6; 6; 6; 12; 3; 12; 3; 3; 6; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0155_a8267510-8c2c-4499-a35d-ac9f21237d91 43857-0155 HUMAN OTC DRUG Amoebatox Triticum Aestivum, Baptisia Tinctoria, Capsicum Annuum, Columbo, Fragaria Vesca, Hamamelis Virginiana LIQUID ORAL 20130415 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALPINE STRAWBERRY; AMOEBA PROTEUS; ATROPA BELLADONNA WHOLE; BAPTISIA TINCTORIA ROOT; BEEF LIVER; BOS TAURUS SPLEEN; CAPSICUM; CINCHONA OFFICINALIS BARK; GIARDIA LAMBLIA; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; JATEORHIZA CALUMBA ROOT; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; QUASSIA AMARA WOOD; SENNA LEAF; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; TRITICUM AESTIVUM WHOLE 3; 15; 12; 3; 8; 8; 3; 12; 15; 3; 3; 3; 12; 12; 3; 3; 12; 8; 1 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0156_b7b91679-e069-42c1-9e97-20ca5ffb8cbc 43857-0156 HUMAN OTC DRUG Mustard Mustard LIQUID ORAL 20121009 UNAPPROVED HOMEOPATHIC BioActive Nutritional SINAPIS ARVENSIS FLOWERING/FRUITING TOP 6 [hp_X]/mL 43857-0157_bc24abeb-03ae-438f-ba7c-3c142317c463 43857-0157 HUMAN OTC DRUG Sinus Tonic Echinacea, Baptisia Tinctoria, Hydrastis Canadensis, Thiaminum Hydrochloricum, Pantothenic Acid, Pyridoxinum Hydrochloricum LIQUID ORAL 20130410 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; ASCORBIC ACID; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; GOLDENSEAL; LACHESIS MUTA VENOM; MERCURIC IODIDE; MERCURIC SULFIDE; PANTOTHENIC ACID; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; SILICON DIOXIDE; SINUSITISINUM; SPONGIA OFFICINALIS SKELETON, ROASTED; THIAMINE HYDROCHLORIDE 12; 12; 3; 12; 2; 3; 12; 12; 12; 6; 12; 12; 6; 12; 30; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0158_2c9a625a-574c-4021-aab4-134ff48bf932 43857-0158 HUMAN OTC DRUG Renaforce Berberis Vulgaris, Echinacea, Coccus Cacti, Kali Muriaticum, Lycopodium Clavatum, Nitricum Acidum LIQUID ORAL 20130920 UNAPPROVED HOMEOPATHIC BioActive Nutritional BERBERIS VULGARIS ROOT BARK; ECHINACEA, UNSPECIFIED; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; POTASSIUM CHLORIDE; PROTORTONIA CACTI 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0159_21005283-364f-4d44-83c4-bb4885328c2d 43857-0159 HUMAN OTC DRUG Arterioforce I Arnica Montana, Lilium Tigrinum, Aurum Muriaticum, Cactus Grandiflorus, Digitalis Purpurea, Glonoinum, Nux Vomica, Veratrum Album LIQUID ORAL 20130417 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; DIGITALIS; GOLD TRICHLORIDE; LILIUM LANCIFOLIUM WHOLE FLOWERING; NITROGLYCERIN; SELENICEREUS GRANDIFLORUS STEM; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 3; 12; 12; 4; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0160_e855c3d8-450e-4850-a240-83d60fdcf21f 43857-0160 HUMAN OTC DRUG Injury Arnica Montana, Calendula Officinalis, Symphtym Officinalis, Hypericum Perforatum, Belladonna, Bellis Perennis LIQUID ORAL 20130417 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACHILLEA MILLEFOLIUM; ACTIVATED CHARCOAL; ARNICA MONTANA; ATROPA BELLADONNA WHOLE; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY LEAF; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 12; 12; 3; 12; 12; 3; 3; 12; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0161_9afa85bb-849d-428a-a408-3a13263d66f2 43857-0161 HUMAN OTC DRUG Norepinephrine Norepinephrine LIQUID ORAL 20130417 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. NOREPINEPHRINE 30 [hp_X]/mL 43857-0162_51d55b54-7aa7-4a0a-a81f-3f293bfe7cfb 43857-0162 HUMAN OTC DRUG Radiation Capsicum annuum, Cetratia iswlandica, Fucus vesiculosus, Glandula suprarenalis suis, Thyroidinum (suis), Cadmium iodatum, Hydrangea arborescens, Phosphoricum acidum, Phosphorus, LIQUID ORAL 20121105 UNAPPROVED HOMEOPATHIC BioActive Nutritional ALCOHOL, X-RAY EXPOSED (1000 RAD); CADMIUM IODIDE; CAPSICUM; CETRARIA ISLANDICA SUBSP. ISLANDICA; FUCUS VESICULOSUS; HYDRANGEA ARBORESCENS ROOT; PHOSPHORIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; STRONTIUM CARBONATE; SUS SCROFA ADRENAL GLAND; THYROID, PORCINE; URANYL NITRATE HEXAHYDRATE 30; 12; 3; 3; 3; 12; 12; 12; 12; 12; 8; 8; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0163_f42f7be2-356a-4edf-8960-8191c34d68ac 43857-0163 HUMAN OTC DRUG Intestaforce Althaea Officinalis, Capsicum Annuum, Foeniculum Vulgare, Symphytum Officinale, Argentum Nitricum, Ferrum Phosphoricum LIQUID ORAL 20130417 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALTHAEA OFFICINALIS ROOT; CAPSICUM; COMFREY ROOT; FENNEL SEED; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS; SILVER NITRATE 3; 3; 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0164_37286661-97ee-485d-84a4-e87d4c8ee284 43857-0164 HUMAN OTC DRUG Circulatone Fagopyrum Esculentum, Magnesia Muriatica, Bioflavonoids, Cor, Thyroidinum, Arsenicum Iodatum, Aurum Muriaticum LIQUID ORAL 20130422 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; ARSENIC TRIIODIDE; BARIUM CHLORIDE DIHYDRATE; CALCIUM IODIDE; CHOLESTEROL; CITRUS BIOFLAVONOIDS; CONIUM MACULATUM FLOWERING TOP; FAGOPYRUM ESCULENTUM; GOLD TRICHLORIDE; LEAD; MAGNESIUM CHLORIDE; PHOSPHORUS; PORK HEART; POTASSIUM IODIDE; SUS SCROFA THYROID 30; 12; 12; 12; 12; 8; 12; 3; 12; 12; 3; 30; 8; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0165_af469faa-1966-4cc4-b3a9-e20c1915d67e 43857-0165 HUMAN OTC DRUG Gynetox Angelica Archangelica, Cimicifuga Racemosa, Zincum Gluconicum, Funiculus Umbilicalis Suis, Lymph Node, Oophorinum LIQUID ORAL 20121226 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANGELICA ARCHANGELICA ROOT; BLACK COHOSH; BORIC ACID; CANDIDA ALBICANS; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN PAPILLOMAVIRUS; JUNIPERUS SABINA LEAFY TWIG; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA OVARY; SUS SCROFA THYROID; SUS SCROFA UMBILICAL CORD; SUS SCROFA UTERUS; WOOD CREOSOTE; ZINC GLUCONATE 3; 3; 12; 30; 30; 30; 30; 30; 12; 30; 30; 12; 12; 9; 8; 8; 9; 8; 8; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0166_d7f39804-fcd6-49f4-9eb5-eac9c63419ac 43857-0166 HUMAN OTC DRUG IMMUNE FORTE Dehydro-Epi-Androsterone (DHEA), Estradiol, Pituitary (Suis), Pregnoenolone, Progesterone, Spleen (Bovine), Testosterone, Thymus (Suis), Thyroidinum (Suis) LIQUID ORAL 20130807 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BOS TAURUS SPLEEN; ESTRADIOL; PRASTERONE; PREGNENOLONE; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; TESTOSTERONE; THYROID, PORCINE 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0167_e211325e-58fb-4ff5-bd71-854ada8ebebc 43857-0167 HUMAN OTC DRUG Oligo Bio Iodine Chelidonium Majus, Spongia Tosta, Iodium, Lycopus Virginicus, Ginkgo Biloba, Pinus Sylvestris, Fucus Vesiculosus, Germanium Sesquioxide LIQUID ORAL 20130812 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. .ALPHA.-KETOGLUTARIC ACID; CHELIDONIUM MAJUS; COPPER; CYSTEINE; EUGENOL; FERROUS IODIDE; FORMALDEHYDE; FUCUS VESICULOSUS; FUMARIC ACID; GERMANIUM SESQUIOXIDE; GINKGO; GOLD; HUMAN COXSACKIEVIRUS A2; HUMAN COXSACKIEVIRUS A7; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B3; HUMAN COXSACKIEVIRUS B4; IODINE; LIDOCAINE; LYCOPUS VIRGINICUS; MANGANESE GLUCONATE; MERCURIUS SOLUBILIS; MOLYBDENUM; MUMPS VIRUS; NICKEL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PALLADIUM; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM IODIDE; PULSATILLA VULGARIS; RUBELLA VIRUS; SILVER; SODIUM DIETHYL OXALACETATE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; TIN; TITANIUM; ZINC 12; 3; 12; 9; 12; 12; 12; 6; 12; 8; 6; 12; 16; 16; 16; 16; 16; 4; 12; 4; 10; 12; 12; 12; 12; 12; 12; 6; 12; 12; 12; 12; 12; 3; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0168_d5467995-dbf1-42ce-b3db-00204a0e9c79 43857-0168 HUMAN OTC DRUG Food Additives Berberis Vulgaris, Chelidonium Majus, Trifolium Pratense, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula LIQUID ORAL 20130516 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; FRANGULA ALNUS BARK; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; SODIUM SULFATE; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK 4; 12; 12; 3; 3; 4; 4; 4; 12; 12; 4; 12; 4; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0169_67419a4f-eb06-4305-99bb-975e8e02e352 43857-0169 HUMAN OTC DRUG Tobaccotox Avena Sativa, Kali Phosphoricum, Cactus Grandiflorus, Daphne Indica, Eucalyptol, Lobelia Inflata, Mentholum LIQUID ORAL 20130604 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AVENA SATIVA FLOWERING TOP; BENZENE; DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; EUCALYPTOL; LOBELIA INFLATA; MENTHOL; NAPHTHALENE; POTASSIUM PHOSPHATE, DIBASIC; SELENICEREUS GRANDIFLORUS STEM; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 1; 15; 3; 12; 3; 3; 3; 15; 2; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0170_93ca3908-aa52-4a14-86e1-140d16252f7a 43857-0170 HUMAN OTC DRUG Cystoforce Sarsaparilla, Solidago Virgaurea, Uva Ursi, Apis Mellifica, Arsenicum Album, Cantharis LIQUID ORAL 20130605 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; ARCTOSTAPHYLOS UVA-URSI LEAF; ARSENIC TRIOXIDE; CALCIUM SULFIDE; LYTTA VESICATORIA; SMILAX REGELII ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 12; 3; 12; 12; 12; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0171_6717dec9-9228-49fa-a95d-662ed89c59fe 43857-0171 HUMAN OTC DRUG Bio Argimony Agrimony LIQUID ORAL 20130531 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AGRIMONIA EUPATORIA 6 [hp_X]/mL 43857-0172_64a4409b-193f-4652-bbad-fa1715ef8007 43857-0172 HUMAN OTC DRUG Diathesis V 1 Ginkgo Biloba, Pancreas, Spleen, Stomach, Germanium Sesquioxide, Cuprum Metallicum, Cysteinum, Zincum Metallicum LIQUID ORAL 20130516 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. .ALPHA.-KETOGLUTARIC ACID; COPPER; CYSTEINE; FUMARIC ACID; GERMANIUM SESQUIOXIDE; GINKGO; MANGANESE GLUCONATE; SODIUM DIETHYL OXALACETATE; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA STOMACH; ZINC 12; 9; 9; 12; 8; 6; 10; 12; 6; 6; 6; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0173_3e0aa066-d8b5-48d5-9bac-6dc1f4548bca 43857-0173 HUMAN OTC DRUG TREE ANTIGEN American Beech, American Elm, Black Walnut, Black Willow, Box Elder, Eastern Cotton Wood, Hickory, Red Birch, Red Oak, Sycamore, White Ash LIQUID ORAL 20130807 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACER NEGUNDO POLLEN; ARSENIC TRIOXIDE; BETULA OCCIDENTALIS POLLEN; CARYA OVATA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; LYCOPODIUM CLAVATUM SPORE; MELALEUCA ALTERNIFOLIA FLOWERING TOP; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; PULSATILLA VULGARIS; QUERCUS RUBRA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN 6; 12; 6; 6; 6; 6; 6; 12; 6; 6; 6; 12; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0174_3a209684-2dfe-4455-baf0-efaaab9a51b4 43857-0174 HUMAN OTC DRUG Bronci HP Carbo Vegetabilis, Cuprum Metallicum, Drosera, Ipecacuanha, Lachesis Mutus, Lobelia Inflata, Phosphorus LIQUID ORAL 20130611 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACTIVATED CHARCOAL; COPPER; DROSERA ROTUNDIFOLIA; IPECAC; LACHESIS MUTA VENOM; LOBELIA INFLATA; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0176_c4670d1c-ab7f-434e-95c8-2d12b38debdb 43857-0176 HUMAN OTC DRUG Cerebroforce Capsicum Annuum, Ginkgo Biloba, Gelsemium Sempervirens, Kali Phosphoricum, Lycopodium Clavatum, Phosphorus, Arsenicum Album LIQUID ORAL 20130910 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc ARSENIC TRIOXIDE; CAPSICUM; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC 30; 3; 12; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0177_97eb0129-1829-4084-99a0-915707f288e1 43857-0177 HUMAN OTC DRUG Candida Candida Albicans LIQUID ORAL 20130910 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CANDIDA ALBICANS 12 [hp_X]/mL 43857-0178_f98ab5e6-6d96-413d-88b9-89c68aff2cb5 43857-0178 HUMAN OTC DRUG Bio Elm Elm LIQUID ORAL 20130611 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ELM 6 [hp_X]/mL 43857-0179_e409f7b5-0eb5-40e8-bdf7-be3b71bab549 43857-0179 HUMAN OTC DRUG Bac HP Apis Mellifica, Arsenicum Album, Belladonna, Chamomilla, Lachesis Mutus, Mercurius Solubilis, Pulsatilla LIQUID ORAL 20130612 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0180_8fe2a08e-a1a1-4541-92fc-6f036c920c53 43857-0180 HUMAN OTC DRUG FEMALE BALANCE Folliculinum, Progesterone, Glycerin, Sodium Benzoate, Citric Acid LIQUID ORAL 20130801 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ESTRONE; PROGESTERONE 6; 6 [hp_X]/mL; [hp_X]/mL 43857-0181_bb6ee8d9-df7f-45c4-ac0c-9afd3374d0a8 43857-0181 HUMAN OTC DRUG Hypert HP Arnica Montana, Aurum Metallicum, Cactus Grandiflorus, Calcarea Carbonica, Natrum Muriaticum, Nux Vomica LIQUID ORAL 20130612 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SELENICEREUS GRANDIFLORUS STEM; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0182_79b4b8e9-9174-41e7-a16a-6c9d0727f563 43857-0182 HUMAN OTC DRUG Bio Wild Oat Wild Oat LIQUID ORAL 20130612 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BROMUS RAMOSUS FLOWER 6 [hp_X]/mL 43857-0183_a1404ce5-5596-4b96-ae4c-3596d10cf59a 43857-0183 HUMAN OTC DRUG Bio Centaury Centaury LIQUID ORAL 20130613 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CENTAURIUM ERYTHRAEA 6 [hp_X]/mL 43857-0184_e453aa7e-fec4-4317-9390-90c956801eed 43857-0184 HUMAN OTC DRUG Candida Alb Candida Albicans LIQUID ORAL 20130612 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CANDIDA ALBICANS 500 [hp_X]/mL 43857-0185_87be2cca-fc49-417a-b4d9-2ac40916aa2a 43857-0185 HUMAN OTC DRUG Candida Alb Candida Albicans LIQUID ORAL 20130612 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CANDIDA ALBICANS 12 [hp_X]/mL 43857-0186_a5b4d93d-7865-48c5-a179-8bd42ad1a093 43857-0186 HUMAN OTC DRUG Gastrotone Capsicum Annuum, Foeniculum Vulgare, Symphytum Officinale, Argentum Nitricum, Arsenicum Album, Magnesia Phosphorica LIQUID ORAL 20130612 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; CAPSICUM; COMFREY ROOT; FENNEL SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PULSATILLA VULGARIS; SILVER NITRATE 12; 3; 3; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0187_3c881637-74a4-4cc2-bc91-bcb66255d4cc 43857-0187 HUMAN OTC DRUG Neurotone Passiflora Incarnata, Glandula Suprarenalis Suis, Thyroidinum, Arnica Montana, Hypericum Perforatum LIQUID ORAL 20130611 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; PASSIFLORA INCARNATA FLOWERING TOP; PTYCHOPETALUM OLACOIDES ROOT; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYROID 12; 12; 12; 3; 15; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0188_cb4acc5c-d910-4122-ae40-82d255e6f6aa 43857-0188 HUMAN OTC DRUG ASTH-HP Arsenicum Album, Belladonna, Ipecacuanha, Kali Carbonicum, Lobelia Inflata, Natrum Sulphuricum, Silicea LIQUID ORAL 20130806 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; IPECAC; LOBELIA INFLATA; POTASSIUM CARBONATE; SILICON DIOXIDE; SODIUM SULFATE 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0189_3bcf5b8a-26a0-46d8-9834-ffb87ed569c3 43857-0189 HUMAN OTC DRUG BIO BEECH Beech LIQUID ORAL 20130806 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. FAGUS SYLVATICA FLOWERING TOP 6 [hp_X]/mL 43857-0190_86992350-f0f7-47f2-af6c-40a0955e176c 43857-0190 HUMAN OTC DRUG PNEUMOPLEX Plantago Major, Arsenicum Album, Lung (Bovine), Symphytum Officinale, Silicea, Phellandrium Aquaticum, Phosphorus, Sulphur LIQUID ORAL 20130807 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; BEEF LUNG; COMFREY ROOT; OENANTHE AQUATICA FRUIT; PHOSPHORUS; PLANTAGO MAJOR; SILICON DIOXIDE; SULFUR 6; 6; 6; 12; 12; 3; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0191_c27fd173-bfda-4e63-9d27-b57ab010b3bc 43857-0191 HUMAN OTC DRUG NEUROFORCE Echinacea, Hypericum Perforatum, Symphytum Officinale, Arnica Montana, Agaricus Muscarius, Arsenicum Album, Gelsemium Sempervirens LIQUID ORAL 20130801 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMANITA MUSCARIA FRUITING BODY; ARNICA MONTANA; ARSENIC TRIOXIDE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; LEAD; TOXICODENDRON PUBESCENS LEAF 12; 3; 12; 3; 3; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0192_5ec52faa-7952-4818-9206-d1e2a2ed43bb 43857-0192 HUMAN OTC DRUG EAR Baptisia Tinctoria, Echincea, Hydrastis Canadensis, Phytolacca Decandra, Capsicum Annuum, Chamomilla, Ferrum Phosphoricum, Kali Muriaticum LIQUID ORAL 20130730 UNAPPROVED HOMEOPATHIC BioActive Nutrional, Inc BAPTISIA TINCTORIA; CAPSICUM; ECHINACEA, UNSPECIFIED; FERRUM PHOSPHORICUM; GOLDENSEAL; MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; POTASSIUM CHLORIDE; PULSATILLA VULGARIS 3; 12; 3; 12; 3; 12; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0193_d4c06e2b-70e8-4154-82e5-a8bc66128867 43857-0193 HUMAN OTC DRUG NEUROTOX not applicable LIQUID ORAL 20140725 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALUMINUM; AMANITA MUSCARIA FRUITING BODY; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ASPARTAME; BARIUM CARBONATE; BENZALKONIUM CHLORIDE; BERYLLIUM; BISMUTH; BORON; BOTULINUM TOXIN TYPE A; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; CITHARACANTHUS SPINICRUS; CLOSTRIDIUM PERFRINGENS; COBALT; CONIUM MACULATUM FLOWERING TOP; COPPER; DYSPROSIUM; ERBIUM; ESCHERICHIA COLI; EUROPIUM OXIDE; FORMALDEHYDE; GADOLINIUM; GELSEMIUM SEMPERVIRENS ROOT; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; HUMAN HERPESVIRUS 4; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); IRIDIUM; IRON; LANTHANUM OXIDE; LATRODECTUS MACTANS; LEAD; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM; MANGANESE; MEASLES VIRUS; MERCURIUS SOLUBILIS; METHYLENE CHLORIDE; METHYLPARABEN; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PHOSPHORUS; PLATINUM; POLIOVIRUS; PRASEODYMIUM; PROPYLPARABEN; PROTEUS VULGARIS; PROTORTONIA CACTI; PSEUDOMONAS AERUGINOSA; RHODIUM; RUBIDIUM; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SAMARIUM OXIDE; SELENIUM; SILVER; SODIUM BENZOATE; SODIUM CITRATE; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; TIN; TITANIUM DIOXIDE; TOXICODENDRON PUBESCENS LEAF; URANIUM; VANADIUM; YERSINIA ENTEROCOLITICA; YTTERBIUM OXIDE; ZINC; ZINC OXIDE 12; 12; 12; 12; 30; 12; 30; 12; 12; 12; 30; 12; 12; 12; 12; 12; 30; 15; 12; 12; 12; 12; 12; 30; 12; 30; 12; 30; 12; 12; 12; 30; 30; 30; 30; 12; 12; 12; 30; 12; 12; 12; 12; 12; 30; 12; 30; 30; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 30; 30; 12; 30; 12; 12; 33; 12; 12; 12; 30; 30; 12; 12; 12; 12; 12; 30; 30; 12; 12; 30; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0194_0dfe14c0-459e-48e0-81da-5ad36199ae5f 43857-0194 HUMAN PRESCRIPTION DRUG THYMUS Thymus (Suis) LIQUID ORAL 20130809 UNAPPROVED HOMEOPATHIC BioActive Nutrional, Inc. SUS SCROFA THYMUS 8 [hp_X]/mL 43857-0195_25470738-ed9f-4452-9fc2-e83c0984f7bc 43857-0195 HUMAN OTC DRUG Flu Tonic Echinacea, Uva-Ursi, Baptisia Tinctoria, Convallaria Majalis, Kali Muriaticum, Pinus Sylvetris, Thuja Occidentalis, Bryonia, Condurango LIQUID ORAL 20130910 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARCTOSTAPHYLOS UVA-URSI LEAF; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; GINKGO; LACHESIS MUTA VENOM; MARSDENIA CONDURANGO BARK; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM CHLORIDE; SELENIUM; TABEBUIA IMPETIGINOSA BARK; THUJA OCCIDENTALIS LEAF; VISCUM ALBUM FRUITING TOP 1; 3; 12; 6; 12; 1; 12; 12; 12; 6; 6; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0196_3189deeb-5c0c-4700-8af4-ec24c1bd1c5e 43857-0196 HUMAN OTC DRUG Throat Formula Baptisia Tinctoria, Phytolacca Decandra, Apis Mellifica, Belladonna, Lachesis Mutus, Mercurius Solubilis, Hepar Sulphuris Calcareum SPRAY ORAL 20130813 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; ATROPA BELLADONNA; BAPTISIA TINCTORIA; CALCIUM SULFIDE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT 12; 12; 3; 15; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0197_af585e1a-24e4-4c22-adab-d3e4a818aa2c 43857-0197 HUMAN OTC DRUG Renotox not applicable LIQUID ORAL 20140728 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AGATHOSMA BETULINA LEAF; ALUMINUM; ANTIMONY TRISULFIDE; ARCTOSTAPHYLOS UVA-URSI LEAF; ARSENIC TRIOXIDE; ASPARAGUS; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BERYLLIUM; BISMUTH; BORON; BOTULINUM TOXIN TYPE A; BROMINE; BRYONIA ALBA ROOT; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; CLOSTRIDIUM PERFRINGENS; COBALT; COPPER; DYSPROSIUM; ECHINACEA ANGUSTIFOLIA; ERBIUM; ESCHERICHIA COLI; EUPATORIUM PURPUREUM ROOT; EUROPIUM OXIDE; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; HUMAN HERPESVIRUS 4; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); IRIDIUM; IRON; LANTHANUM OXIDE; LEAD; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MEASLES VIRUS; MERCURIC CHLORIDE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PETROSELINUM CRISPUM; PLATINUM; POLIOVIRUS; PORK KIDNEY; POTASSIUM CHLORIDE; PRASEODYMIUM; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; RHODIUM; RUBIDIUM; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SAMARIUM OXIDE; SAW PALMETTO; SELENIUM; SILVER; SOLIDAGO VIRGAUREA FLOWERING TOP; STRONTIUM CARBONATE; TANTALUM; TARAXACUM OFFICINALE; TERBIUM; THALLIUM; TIN; TRITICUM AESTIVUM WHOLE; URANYL NITRATE HEXAHYDRATE; VANADIUM; YERSINIA ENTEROCOLITICA; YTTERBIUM OXIDE; ZINC 3; 12; 12; 3; 12; 3; 12; 3; 12; 12; 12; 30; 12; 12; 12; 12; 12; 12; 15; 12; 12; 12; 3; 12; 30; 6; 12; 12; 12; 12; 12; 30; 30; 30; 30; 12; 12; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 12; 12; 12; 3; 12; 30; 8; 3; 12; 30; 30; 12; 12; 33; 12; 3; 12; 12; 3; 12; 12; 3; 12; 12; 12; 1; 12; 12; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0198_7a3a2d75-a0bd-46a5-85ab-4a9f9c00908b 43857-0198 HUMAN OTC DRUG Hydrate I Coffea Tosta, Ginkgo Biloba, Germanium Sesquioxide, Silicea LIQUID ORAL 20130911 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. COFFEA ARABICA SEED, ROASTED; GERMANIUM SESQUIOXIDE; GINKGO; SILICON DIOXIDE 1; 8; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0199_f2e48989-cf61-4484-9ad1-64a810c99031 43857-0199 HUMAN OTC DRUG Virotox Echinacea, Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Glandula Suprarenalis Bovine LIQUID ORAL 20130815 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA; BOS TAURUS ADRENAL GLAND; BOS TAURUS THYMUS; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MYRRH; NASTURTIUM AQUATICUM; RANCID BEEF; STRYCHNOS NUX-VOMICA SEED; TABEBUIA IMPETIGINOSA BARK 12; 8; 8; 3; 12; 3; 3; 12; 3; 3; 30; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0201_7f601bb4-2996-4be4-9b24-7fadfc8f6c1e 43857-0201 HUMAN OTC DRUG VERTIFORCE Leonurus Cardiaca, Agaricus Muscarius, Arsenicum Album, Cocculus Indicus, Conium Maculatum, Petroleum, Phosphorus, Pulsatilla, Tabacum, Theridion LIQUID ORAL 20130812 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMANITA MUSCARIA FRUITING BODY; ANAMIRTA COCCULUS SEED; ARSENIC TRIOXIDE; CONIUM MACULATUM FLOWERING TOP; LEONURUS CARDIACA; LIQUID PETROLEUM; PHOSPHORUS; PULSATILLA VULGARIS; THERIDION CURASSAVICUM; TOBACCO LEAF 12; 12; 12; 12; 3; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0202_51ec9c0c-0471-4fda-b5cb-66f5dc9d9119 43857-0202 HUMAN OTC DRUG Grippe HP Aconitum Napellus, Arsenicum Album, Belladonna, Bryonia, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens LIQUID ORAL 20130911 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0203_fd383fac-9ce9-4db5-8930-d9505c2816d9 43857-0203 HUMAN OTC DRUG Menopause HP Belladonna, Lachesis Mutus, Nux Vomica, Pulsatilla, Secale Cornutum, Sepia, Ustilago Maidis LIQUID ORAL 20130911 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA; CLAVICEPS PURPUREA SCLEROTIUM; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; USTILAGO MAYDIS 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0204_7acf3966-8385-4d77-962f-0c4770f5ba7a 43857-0204 HUMAN OTC DRUG Ovaplex Angelica Archangelica, Caulophyllum Thalictroides, Disoscorea Villosa, Oophorinum (Suis) Thyroidinum (Suis), Uterus (Suis), Zincum Gluconicum LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANGELICA ARCHANGELICA ROOT; APIS MELLIFERA; ATROPA BELLADONNA; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; DIOSCOREA VILLOSA TUBER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEPIA OFFICINALIS JUICE; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; SUS SCROFA UTERUS; ZINC GLUCONATE 3; 12; 12; 12; 3; 3; 12; 12; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0205_1371efd5-2e56-444e-bf99-788561c0e934 43857-0205 HUMAN OTC DRUG Parathyroplex Parathyroid (Bovine), Baryta Carbonica, Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Cuprum Metallicum, Magnesia Phosphorica LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BARIUM CARBONATE; BOS TAURUS PARATHYROID GLAND; CALCIUM FLUORIDE; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE 12; 6; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0206_a83621a3-fbe5-4c55-8445-5ea3827ffe03 43857-0206 HUMAN OTC DRUG Rhustoxoforce Apis Mellifica, Cantharis, Graphites, Natrum Muriaticum, Rhus Glabra, Rhus Toxicodendron, Rhus Venenata, Urtica Dioica LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; GRAPHITE; LYTTA VESICATORIA; RHUS GLABRA TOP; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF; TOXICODENDRON VERNIX LEAFY TWIG; URTICA DIOICA 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0207_87c4fb32-b88d-421b-b2f3-482bcf74a465 43857-0207 HUMAN OTC DRUG Septaforce Baptisia Tinctoria, Echinacea, Arsenicum Album, Chininum Sulphuricum, Crotalus Horridus, Lachesis Mutus, Loxosceles Reclusa LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA; CITHARACANTHUS SPINICRUS; CLAVICEPS PURPUREA SCLEROTIUM; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LOXOSCELES RECLUSA; QUININE SULFATE 12; 33; 3; 12; 12; 12; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0208_29abd755-83b9-45de-b0cd-0005104f9060 43857-0208 HUMAN OTC DRUG Oligo Bio Iodine Chelidonium Majus, Spongia Tosta, Iodium, Lycopus Virginicus, Ginkgo Biloba, Pinus Sylvestris, Fucus Vesiculosus, Germanium Sesquioxide, Pituitaria Glandula, Thyroidinum, Cysteinum, Manganese Gluconate, LIQUID ORAL 20131021 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. .ALPHA.-KETOGLUTARIC ACID; CHELIDONIUM MAJUS; COPPER; CYSTEINE; EUGENOL; FERROUS IODIDE; FORMALDEHYDE; FUCUS VESICULOSUS; FUMARIC ACID; GERMANIUM SESQUIOXIDE; GINKGO; GOLD; HUMAN COXSACKIEVIRUS A2; HUMAN COXSACKIEVIRUS A7; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B3; HUMAN COXSACKIEVIRUS B4; IODINE; LIDOCAINE; LYCOPUS VIRGINICUS; MANGANESE GLUCONATE; MERCURIUS SOLUBILIS; MOLYBDENUM; MUMPS VIRUS; NICKEL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PALLADIUM; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM IODIDE; PULSATILLA VULGARIS; RUBELLA VIRUS; SILVER; SODIUM DIETHYL OXALACETATE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; TIN; TITANIUM; ZINC 12; 3; 12; 9; 12; 12; 12; 6; 12; 8; 6; 12; 16; 16; 16; 16; 16; 4; 12; 4; 10; 12; 12; 12; 12; 12; 12; 6; 12; 12; 12; 12; 12; 3; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0209_1e4868da-138c-473f-a5a4-154ef3217aa0 43857-0209 HUMAN OTC DRUG Cerebraplex Avena Sativa, Capsicum Annuum, Ginkgo Biloba, Hydrocotyle Asiatica, Polygonum Multiflorum, Rosmarinus Officinalis, Vinca Minor, Brain (Suis) LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; CAPSICUM; CENTELLA ASIATICA; DATURA STRAMONIUM; FALLOPIA MULTIFLORA ROOT; GERMANIUM SESQUIOXIDE; GINKGO; PORK BRAIN; POTASSIUM PHOSPHATE, DIBASIC; ROSMARINUS OFFICINALIS FLOWERING TOP; VINCA MINOR 12; 3; 12; 3; 3; 12; 3; 12; 3; 6; 12; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0210_d2310d30-e673-4290-a100-9e24fdb593ed 43857-0210 HUMAN OTC DRUG Endoplex F Cimicifuga Racemosa, Fucus Vesiculosus, Glycyrrhiza Glabra, Xathoxylum Fraxineum, Adrenalinum, Brain (Suis), Hypothalamus (Suis) LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BLACK COHOSH; EPINEPHRINE; FUCUS VESICULOSUS; GLYCYRRHIZA GLABRA; PORK BRAIN; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; ZANTHOXYLUM AMERICANUM BARK 3; 8; 3; 3; 8; 12; 12; 8; 8; 8; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0211_ec9e0943-dbd0-4d92-8e48-ba832d12bc34 43857-0211 HUMAN OTC DRUG BAC Echinacea (Angustifolia), Hydrastis canadensis, Lomatium dissectum, Myrrha, Nasturtium aquaticum, Tabebuia impetiginosa, Propolis, Glandula suprarenalis suis, LIQUID ORAL 20140617 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC ACID; ATROPA BELLADONNA; BOTULINUM TOXIN TYPE A; CLOSTRIDIUM PERFRINGENS; ECHINACEA ANGUSTIFOLIA; ESCHERICHIA COLI; GOLDENSEAL; HYPERICUM PERFORATUM; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM OFFICINALE; PHOSPHORUS; PROPOLIS WAX; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; THYROID, PORCINE; YERSINIA ENTEROCOLITICA 12; 12; 30; 15; 3; 30; 3; 12; 3; 3; 3; 12; 6; 30; 30; 33; 8; 8; 8; 8; 3; 8; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0212_725d72e3-9f9a-4d33-831d-7a4734a3920a 43857-0212 HUMAN OTC DRUG Venoforce II Collinsonia Canadensis, Hamamelis Virginiana, Aesculus Hippocastanum, Belladonna, Calcarea Fluorica, Carduus Marianus, Pulsatilla LIQUID ORAL 20130822 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA; CALCIUM FLUORIDE; CLAVICEPS PURPUREA SCLEROTIUM; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; PULSATILLA VULGARIS; SILYBUM MARIANUM SEED; VIPERA BERUS VENOM 12; 12; 12; 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0213_81c1d0c0-62a9-496e-8e8d-e91100dd9048 43857-0213 HUMAN OTC DRUG Pneumo HP Ammonium Muriaticum, Antimonium Tartaricum, Arsenicum Album, Calcarea Carbonica, Lobelia Inflata, Natrum Sulphuricum, Spongia Tosta, Phosphorus, LIQUID ORAL 20140122 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMMONIUM CHLORIDE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; LOBELIA INFLATA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0215_e5cd721a-55ec-420b-ae87-ba136780ef0a 43857-0215 HUMAN OTC DRUG Arterioforce II Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Phytolacca Decandra, Myrrha, Nasturtium Aquaticum, Trigonella Foenum-graecum LIQUID ORAL 20130910 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; BAPTISIA TINCTORIA; BARIUM CARBONATE; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; FENUGREEK SEED; GOLDENSEAL; MYRRH; NASTURTIUM AQUATICUM; PHYTOLACCA AMERICANA ROOT; POTASSIUM IODIDE; PROPOLIS WAX; SELENICEREUS GRANDIFLORUS STEM 6; 3; 12; 12; 12; 3; 4; 3; 4; 4; 3; 5; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0216_2cc09361-1ccf-4b43-a544-931cb795b721 43857-0216 HUMAN OTC DRUG Depressoforce Picricum acidum, Arsenicum album, Aurum metallicum, Ignatia amara, Natrum muriaticum, Nitricum acidum, Pulsatilla (Vulgaris), Sepia, LIQUID ORAL 20140616 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; GOLD; NITRIC ACID; PICRIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 30; 30; 30; 12; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0218_190e45f2-2db3-4be7-af16-ec33607fbfdd 43857-0218 HUMAN OTC DRUG Interferon Interferon (Suis) LIQUID ORAL 20130923 UNAPPROVED HOMEOPATHIC BioActive Nutritional INTERFERON .GAMMA. PORCINE RECOMBINANT 6 [hp_C]/mL 43857-0219_e1004775-bcf8-4e63-835f-431624216b46 43857-0219 HUMAN OTC DRUG Bio Aspen Aspen LIQUID ORAL 20130830 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. POPULUS TREMULA FLOWERING TOP 6 [hp_X]/mL 43857-0220_0d3ba25b-7a1b-4b42-b617-949b32844699 43857-0220 HUMAN OTC DRUG Bio Rock Water Rock Water LIQUID ORAL 20130829 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. WATER 6 [hp_X]/mL 43857-0221_bf134eb5-91ad-42b4-a4ad-6e8478399b9d 43857-0221 HUMAN OTC DRUG NV-HP Arsenicum Album, Cocculus Indicus, Ipecacuanha, Kerosotum, Petroleum, Pulsatilla, Sanguinaria Canadensis, Tabacum LIQUID ORAL 20130917 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANAMIRTA COCCULUS SEED; ARSENIC TRIOXIDE; IPECAC; LIQUID PETROLEUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; TOBACCO LEAF; WOOD CREOSOTE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0222_1b18593b-09b2-47b1-9e44-f75ad5fb3933 43857-0222 HUMAN OTC DRUG Animal Antigens Canary Feathers, Cat Hair, Cattle Epithelia, Chicken Feathers, Dog Epithelia, Duck Feathers, Gerbil Epithelia, Goat Epithelia, Goose Feathers LIQUID ORAL 20130919 UNAPPROVED HOMEOPATHIC BioActive Nutritional ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ARSENIC TRIOXIDE; BOS TAURUS SKIN; CANIS LUPUS FAMILIARIS SKIN; CAPRA HIRCUS SKIN; CAVIA PORCELLUS SKIN; EQUUS CABALLUS SKIN; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; MELOPSITTACUS UNDULATUS FEATHER; MERIONES UNGUICULATUS SKIN; MESOCRICETUS AURATUS SKIN; MUS MUSCULUS SKIN; ORYCTOLAGUS CUNICULUS SKIN; PHOSPHORUS; RATTUS NORVEGICUS SKIN; SERINUS CANARIA FEATHER; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA SKIN 9; 9; 12; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 9; 9; 12; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0223_d4cfe9d4-4d60-4596-9c11-a81b6596636a 43857-0223 HUMAN OTC DRUG Dairy Antigens American Cheese, Blue Cheese, Brie Cheese, Cheddar Cheese, Cottage Cheese, Swiss Cheese, Lac Vaccinum, Goat Milk LIQUID ORAL 20130920 UNAPPROVED HOMEOPATHIC BioActive Nutritional CASEIN, EMMENTAL CULTURED; CASEIN, LACTOCOCCUS LACTIS CULTURED; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; COW MILK; GOAT MILK; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE; SKIM MILK; SULFUR; WHEY 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0224_80959d98-2bd9-4037-a3ac-ded655a75457 43857-0224 HUMAN OTC DRUG Prostatone HP Clematis Erecta, Conium Maculatum, Lycopodium Clavatum, Mercurius Corosivus, Pulsatilla, Sabal Serrulata, Selenium Metallicum LIQUID ORAL 20130920 UNAPPROVED HOMEOPATHIC BioActive Nutritional CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; PULSATILLA VULGARIS; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0225_0fd63c0b-c1ee-4247-b961-1453c0e3b5e3 43857-0225 HUMAN OTC DRUG Household Antigens Acetone, Sodium Tripolyphosphate, Propylene Glycol, Sodium Benzene Sulfonate, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terbinthina LIQUID ORAL 20130918 UNAPPROVED HOMEOPATHIC BioActive Nutritional ACETONE; AMMONIUM CHLORIDE; GRAPHITE; NITRIC ACID; PROPYLENE GLYCOL; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SODIUM BENZENESULFONATE; SODIUM LAURYL SULFATE; SODIUM TRIPOLYPHOSPHATE; SULFUR; TURPENTINE OIL 9; 9; 12; 12; 9; 12; 12; 9; 9; 9; 12; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0229_687848c1-38a4-438b-b3dd-69922911ed00 43857-0229 HUMAN OTC DRUG Taurine Taurine LIQUID ORAL 20130923 UNAPPROVED HOMEOPATHIC BioActive Nutritional TAURINE 6 [hp_X]/mL 43857-0230_eb23a6bf-6e2f-4cfb-904c-675334dd8034 43857-0230 HUMAN OTC DRUG Cryptotox Combo Crotalus Horridus, Naja Tripudians, Oxyuranus Scutellatus Canni, Cenchris Contortrix LIQUID ORAL 20130923 UNAPPROVED HOMEOPATHIC BioActive Nutritional AGKISTRODON CONTORTRIX VENOM; CROTALUS DURISSUS TERRIFICUS VENOM; CROTALUS HORRIDUS HORRIDUS VENOM; NAJA NAJA VENOM; OXYURANUS SCUTELLATUS CANNI VENOM 15; 12; 12; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 43857-0231_0e3965d4-a508-4241-b918-f0025b975b42 43857-0231 HUMAN OTC DRUG Hepataforce Carduus Marianus, Chelidonium Majus, Taraxacum Officinale, Lycopodium Clavatum, Magnesia Phosphorica, Natrum Sulphuricum LIQUID ORAL 20130925 UNAPPROVED HOMEOPATHIC BioActive Nutritional CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILYBUM MARIANUM SEED; SODIUM SULFATE; TARAXACUM OFFICINALE 3; 12; 12; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0232_1a6f219d-eb85-404f-8f54-e53b741975b3 43857-0232 HUMAN OTC DRUG Tryptophan Tryptophan LIQUID ORAL 20130925 UNAPPROVED HOMEOPATHIC BioActive Nutritional TRYPTOPHAN 6 [hp_X]/mL 43857-0233_46206209-2bf0-4907-8917-aa9aeeb8762c 43857-0233 HUMAN OTC DRUG OB Metab Fucus Vesiculosus, Capsicum Annuum, Nicotinamidum, Spongia Tosta, L-Arginine, Croton Oil, L-Ornithine, Pituitaria Glandula (Suis) LIQUID ORAL 20130926 UNAPPROVED HOMEOPATHIC BioActive Nutritional ARGININE; CAPSICUM; CROTON OIL; FUCUS VESICULOSUS; GRAPHITE; NIACINAMIDE; ORNITHINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; TYROSINE 6; 3; 6; 2; 12; 5; 6; 12; 12; 5; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0234_a51c874e-e431-46ef-aa71-4859d8171362 43857-0234 HUMAN OTC DRUG Gallic Acid Gallicum Acidum LIQUID ORAL 20130923 UNAPPROVED HOMEOPATHIC BioActive Nutritional GALLIC ACID MONOHYDRATE 6 [hp_X]/mL 43857-0235_92f766bc-ca2f-4fd5-ba38-5131ed00af32 43857-0235 HUMAN OTC DRUG Bio Larch Larix Decidua LIQUID ORAL 20131002 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. LARIX DECIDUA FLOWERING TOP 6 [hp_X]/mL 43857-0236_41a3d9e6-c9a4-40bd-b73f-1da76a63c0f2 43857-0236 HUMAN OTC DRUG Bio Olive Olea Europaea LIQUID ORAL 20131002 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. OLEA EUROPAEA FLOWER 6 [hp_X]/mL 43857-0237_b72b71bc-10c1-4b47-b349-ee0cd0807ee8 43857-0237 HUMAN OTC DRUG Bio Pine Pinus Sylvestris LIQUID ORAL 20131002 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PINUS SYLVESTRIS FLOWERING TOP 6 [hp_X]/mL 43857-0238_8bcbd185-5c1e-4acf-8aa5-74bfd0775590 43857-0238 HUMAN OTC DRUG Bio Vervain not applicable LIQUID ORAL 20140822 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. VERBENA OFFICINALIS FLOWERING TOP 6 [hp_X]/mL 43857-0239_b6c4d38d-2847-4ea1-a1b3-62d35bb77ec7 43857-0239 HUMAN OTC DRUG Bio White Chestnut White Chestnut LIQUID ORAL 20131002 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HORSE CHESTNUT 6 [hp_X]/mL 43857-0240_0fdf958f-89fd-4f8f-b55b-44982af70282 43857-0240 HUMAN OTC DRUG Bio Willow Salix Vitellina LIQUID ORAL 20131002 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SALIX ALBA FLOWERING TOP 6 [hp_X]/mL 43857-0241_2c2a4580-774b-4ff2-8f78-0db9233bf7ff 43857-0241 HUMAN OTC DRUG Allergen I Potassium Gluconate, Glandula Suprarenalis Bovine, Hepar Bovine, Arsenicum Album, Lycopodium Clavatum, Nux Vomica, Phosphorus LIQUID ORAL 20130926 UNAPPROVED HOMEOPATHIC BioActive Nutritional ALMOND; APPLE; ARSENIC TRIOXIDE; BANANA; BEEF; BEEF LIVER; BLACK PEPPER; BLACK WALNUT; BOS TAURUS ADRENAL GLAND; BRAZIL NUT; CASEIN, LACTOCOCCUS LACTIS CULTURED; CASHEW; CHICKEN; COCONUT; COD, UNSPECIFIED; CORTISONE ACETATE; COW MILK; EGG; EGGPLANT; ENGLISH WALNUT; FLAX SEED; HISTAMINE DIHYDROCHLORIDE; HYALURONIDASE; INTERFERON .GAMMA. PORCINE RECOMBINANT; KIDNEY BEAN; LAMB; LEVANT COTTON SEED; LIMULUS POLYPHEMUS; LYCOPODIUM CLAVATUM SPORE; ONION; ORANGE; OYSTER, UNSPECIFIED; PEANUT; PECAN; PHOSPHORUS; PORK; POTASSIUM GLUCONATE; POTATO; SALMON, UNSPECIFIED; SEROTONIN HYDROCHLORIDE; SESAME SEED; SHRIMP, UNSPECIFIED; STRAWBERRY; STRYCHNOS NUX-VOMICA SEED; TOMATO; TUNA, UNSPECIFIED; WHEAT 12; 12; 12; 12; 12; 8; 12; 12; 8; 12; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 30; 30; 30; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 6; 12; 12; 30; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0242_3db1c86c-5c3f-4050-b42a-0299d6f1046b 43857-0242 HUMAN OTC DRUG Serotonin Serotonin LIQUID ORAL 20130925 UNAPPROVED HOMEOPATHIC BioActive Nutritional SEROTONIN HYDROCHLORIDE 6 [hp_X]/mL 43857-0243_1428f249-a422-4072-97d4-8c2333bafa88 43857-0243 HUMAN OTC DRUG Serotonin Serotonin LIQUID ORAL 20130925 UNAPPROVED HOMEOPATHIC BioActive Nutritional SEROTONIN HYDROCHLORIDE 6 [hp_X]/mL 43857-0244_7d134ead-078f-422e-984f-f07008413234 43857-0244 HUMAN OTC DRUG Metabolism Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Rhamnus Purshiana, Trifolium Pratense, Xanthoxylum Fraxineum, Ascorbic Acid LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. .ALPHA.-KETOGLUTARIC ACID; ADENOSINE TRIPHOSPHATE; ARCTIUM LAPPA ROOT; ASCORBIC ACID; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CYANOCOBALAMIN; CYSTEINE; FRANGULA PURSHIANA BARK; FUMARIC ACID; GERMANIUM SESQUIOXIDE; GLYCYRRHIZA GLABRA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE GLUCONATE; PULSATILLA VULGARIS; PYRUVIC ACID; RIBOFLAVIN; SODIUM DIETHYL OXALACETATE; THIAMINE HYDROCHLORIDE; TRIFOLIUM PRATENSE FLOWER; UBIDECARENONE; ZANTHOXYLUM AMERICANUM BARK 12; 12; 3; 6; 3; 30; 6; 9; 3; 12; 8; 3; 12; 10; 12; 12; 6; 12; 6; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0245_b0f5d4dc-20fa-4cbf-bf2a-04c88224b54f 43857-0245 HUMAN OTC DRUG Serotonin Serotonin (Hydrochloride) LIQUID ORAL 20130930 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SEROTONIN HYDROCHLORIDE 6 [hp_X]/mL 43857-0246_58f13b5f-6d26-43e0-849e-12249eb57450 43857-0246 HUMAN OTC DRUG Universaltox Alfalfa, Avena Sativa, Fucus Vesiculosus, Hordeum Vulgare, Nasturtium Aquaticum, Raphanus Sativus, Triticum Aestivum, Iodium, Ubiquinone LIQUID ORAL 20140110 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. 2,5-DIAMINOTOLUENE SULFATE; ALFALFA; AMMONIUM THIOGLYCOLATE; ANHYDROUS CITRIC ACID; ANTHRAQUINONE; AVENA SATIVA FLOWERING TOP; BROWN RICE; CORTISONE ACETATE; DIMETHICONE; ETHANOLAMINE; ETHYLENE GLYCOL; FUCUS VESICULOSUS; GLUTARAL; GLYCOLIC ACID; HORDEUM VULGARE TOP; HYDROGEN PEROXIDE; IODINE; MANGANESE GLUCONATE; METHYL ACRYLATE; NASTURTIUM AQUATICUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; P-AMINOPHENOL; PALMITIC ACID; PARAFFIN; PORK LIVER; PROPYL ALCOHOL; PULSATILLA VULGARIS; RAPHANUS SATIVUS; SODIUM CARBONATE; SODIUM CHLORIDE; SODIUM POLYACRYLATE (8000 MW); SUS SCROFA ADRENAL GLAND; SUS SCROFA THYROID; TARTARIC ACID; TOXICODENDRON PUBESCENS LEAF; TRITICUM AESTIVUM WHOLE; UBIDECARENONE 30; 3; 30; 30; 30; 3; 8; 30; 30; 30; 30; 4; 30; 30; 4; 30; 6; 8; 30; 4; 12; 30; 30; 30; 8; 30; 12; 4; 30; 12; 30; 8; 8; 30; 12; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0247_d069fce3-a3ae-4304-88ea-19ae44096ee5 43857-0247 HUMAN OTC DRUG Candida Alb Candida Albicans LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CANDIDA ALBICANS 30 [hp_X]/mL 43857-0248_eb08589f-d9f9-4d37-b6a1-437e06ca9b33 43857-0248 HUMAN OTC DRUG Prostoforce Aralia Quinquefolia, Damiana, Hydrocotyle Asiatica, Juniperus Virginiana, Pareira Brava, Sabal Serrulata, Thuja Occidentalis, Clematis Erecta LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMERICAN GINSENG; CENTELLA ASIATICA; CHONDRODENDRON TOMENTOSUM ROOT; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; JUNIPERUS VIRGINIANA OIL; PULSATILLA VULGARIS; SAW PALMETTO; THUJA OCCIDENTALIS LEAF; TURNERA DIFFUSA LEAFY TWIG 3; 3; 3; 12; 12; 3; 12; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0251_e9ac3efe-2023-4fd7-92cd-60a915ad8d3b 43857-0251 HUMAN OTC DRUG Candida Alb Candida Albicans LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CANDIDA ALBICANS 200 [hp_X]/mL 43857-0252_f0993f92-0403-4d34-bbeb-645683b6b252 43857-0252 HUMAN OTC DRUG Eczemaforce Lappa Major, Phytolacca Decandra, Trifolium Pratense, Hydrocotyle Asiatica, Arsenicum Album, Graphites, Mezereum LIQUID ORAL 20140716 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; CENTELLA ASIATICA; DAPHNE MEZEREUM BARK; GRAPHITE; PHYTOLACCA AMERICANA ROOT; TRIFOLIUM PRATENSE FLOWER 3; 12; 6; 12; 12; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0255_466f6089-083a-4810-84f5-7e3d5d8e25e2 43857-0255 HUMAN OTC DRUG Eczema-HP not applicable LIQUID ORAL 20140804 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; DAPHNE MEZEREUM BARK; GRAPHITE; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE; SULFUR; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0256_1e0316ee-2b5b-4753-873d-e43d6e06309d 43857-0256 HUMAN OTC DRUG Dopamine not applicable LIQUID ORAL 20140812 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. DOPAMINE 6 [hp_X]/mL 43857-0257_6688b20f-ab3b-4dc1-9ccb-9fe972027f55 43857-0257 HUMAN OTC DRUG OB METAB not applicable LIQUID ORAL 20140731 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARGININE; CAPSICUM; CROTON TIGLIUM SEED; FUCUS VESICULOSUS; GRAPHITE; NIACINAMIDE; ORNITHINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; TYROSINE 6; 3; 6; 2; 12; 5; 6; 12; 12; 5; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0258_59a9b544-8939-4775-8e71-e4ab97539340 43857-0258 HUMAN OTC DRUG Cardioforce I Arnica montana, Cactus grandiflorus, Capsicum annuum, Spigelia anthelmia, Digitalis purpurea, Kali phosphoricum, Laurocerasus, Tabacum, LIQUID ORAL 20140611 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; ARNICA MONTANA; CAPSICUM; DIGITALIS; GOLD TRICHLORIDE; KALMIA LATIFOLIA LEAF; LATRODECTUS MACTANS; NITROGLYCERIN; POTASSIUM PHOSPHATE, DIBASIC; PRUNUS LAUROCERASUS LEAF; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; STRYCHNOS IGNATII SEED; TOBACCO LEAF; VALERIAN 12; 12; 3; 3; 6; 12; 12; 12; 12; 6; 6; 3; 3; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0259_537b9967-9b2f-4b8c-9cb7-a02c5d9069bf 43857-0259 HUMAN OTC DRUG Strength M Aralia quinquefolia, Avena sativa, Damaina, L-Arginne, Epimedium, Glutathion, L-Leucine, L-Ornithine, Valine, Testosterone, Sabal serrulata, Sepia, LIQUID ORAL 20140617 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMERICAN GINSENG; ARGININE; AVENA SATIVA FLOWERING TOP; EPIMEDIUM GRANDIFLORUM TOP; GLUTATHIONE; LEUCINE; ORNITHINE; SAW PALMETTO; SEPIA OFFICINALIS JUICE; TESTOSTERONE; TURNERA DIFFUSA LEAFY TWIG; VALINE 3; 6; 3; 6; 6; 6; 6; 24; 30; 12; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0261_5a536895-2dcf-4c48-93d5-30debb322bc4 43857-0261 HUMAN OTC DRUG Headache Tonic not applicable LIQUID ORAL 20140812 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CLAVICEPS PURPUREA SCLEROTIUM; GELSEMIUM SEMPERVIRENS ROOT; MELILOTUS OFFICINALIS TOP; MILK THISTLE; NITROGLYCERIN; SEPIA OFFICINALIS JUICE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; TANACETUM PARTHENIUM 12; 12; 12; 6; 12; 12; 1; 12; 12; 12; 12; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0262_dc63c92e-b922-43e3-a79e-73ef21f2b215 43857-0262 HUMAN OTC DRUG Psorinum Complex not applicable LIQUID ORAL 20140822 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALOE; PHOSPHORUS; SILICON DIOXIDE; SULFUR 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 43857-0263_fc3a3148-5832-4ece-8515-100a7674a559 43857-0263 HUMAN OTC DRUG Biting Insect Antigens Apis millifica, Hypericum perforatum, Ledum palustre, Cimex lectularus (Bed Bug), Formica rufa (Red Wood Ants), Pulex irritans (Human flea), Vespa crabro (Hornet, Wasp), LIQUID ORAL 20140616 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; CIMEX LECTULARIUS; FORMICA RUFA; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PULEX IRRITANS; VESPA CRABRO 12; 15; 15; 12; 12; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0264_6f6f45d0-4300-409e-b612-6ec4d8134361 43857-0264 HUMAN OTC DRUG RUTIN not applicable LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. RUTIN 6 [hp_X]/mL 43857-0265_40a07315-2e9a-4af1-b5ca-7c3969280753 43857-0265 HUMAN OTC DRUG L DOPA 4X not applicable LIQUID ORAL 20140805 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. LEVODOPA 4 [hp_X]/mL 43857-0266_263afa13-f207-410d-9481-9ed31c8bc871 43857-0266 HUMAN OTC DRUG Rheumatism HP not applicable LIQUID ORAL 20140822 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0267_51684af8-b680-43bb-b036-a6ba90f8feac 43857-0267 HUMAN OTC DRUG SCROPHULOUS HP not applicable LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BARIUM CARBONATE; BROMINE; FERROUS IODIDE; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0268_77ef3b1b-e5e2-4589-bd67-5f280561e13c 43857-0268 HUMAN OTC DRUG Natural Testosterone Avena sativa. Epimediium, Lycopodium clavatum, Damiana, Testosterone, Agnus castus, SPRAY ORAL 20140224 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AVENA SATIVA FLOWERING TOP; CHASTE TREE; EPIMEDIUM GRANDIFLORUM TOP; LYCOPODIUM CLAVATUM SPORE; TESTOSTERONE; TURNERA DIFFUSA LEAFY TWIG 3; 12; 3; 3; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0269_2feb34de-cc93-4baf-8777-4394604d76e2 43857-0269 HUMAN OTC DRUG Bio Star Of Bethlehem 6X, 30C, 200C Ornithogallum Umbellatum, Flos LIQUID ORAL 20140702 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ORNITHOGALUM UMBELLATUM FLOWERING TOP 6 [hp_X]/mL 43857-0270_dc876914-1970-42df-bb07-e0978d5f5b08 43857-0270 HUMAN OTC DRUG Acetylcholine Chloride not applicable LIQUID ORAL 20140822 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACETYLCHOLINE CHLORIDE 6 [hp_X]/mL 43857-0271_a99269f4-8abf-494a-b2a8-74d9351a7b99 43857-0271 HUMAN OTC DRUG Bio Vine Not applicable LIQUID ORAL 20140822 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. VITIS VINIFERA FLOWERING TOP 6 [hp_X]/mL 43857-0272_5fe223e3-2c46-401a-a585-0507dd3a5861 43857-0272 HUMAN OTC DRUG Coumarin Not applicable LIQUID ORAL 20140805 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. COUMARIN 6 [hp_X]/mL 43857-0273_e8ab4623-6302-418c-9cba-7a1589d55e5d 43857-0273 HUMAN OTC DRUG Androtox Not applicable LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ASTRAGALUS PROPINQUUS ROOT; BOTULINUM TOXIN TYPE A; CALCIUM SULFATE ANHYDROUS; CENTELLA ASIATICA; ECHINACEA ANGUSTIFOLIA; ESCHERICHIA COLI; JUNIPERUS VIRGINIANA TWIG; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHOSPHORUS; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SAW PALMETTO; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA PROSTATE; SUS SCROFA TESTICLE; TABEBUIA IMPETIGINOSA BARK; THUJA OCCIDENTALIS LEAFY TWIG; YERSINIA ENTEROCOLITICA; ZINC GLUCONATE 6; 30; 30; 3; 3; 30; 3; 30; 12; 30; 30; 30; 12; 12; 33; 3; 12; 12; 6; 6; 12; 12; 3; 3; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0274_3d8008ea-76c7-4a2d-a477-a680b83e6b6e 43857-0274 HUMAN OTC DRUG Free Radical not applicable LIQUID ORAL 20140804 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. .ALPHA.-KETOGLUTARIC ACID; ALFALFA; ALUMINUM; ANTIMONY TRISULFIDE; ARNICA MONTANA; ARSENIC TRIOXIDE; ASPARAGUS; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; BROWN RICE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COMFREY ROOT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; FERROSOFERRIC PHOSPHATE; FUCUS VESICULOSUS; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; GLYOXAL TRIMER DIHYDRATE; GOLD; HOLMIUM; HORDEUM VULGARE TOP; IRIDIUM; IRON; LAMINARIA DIGITATA; LANTHANUM OXIDE; LEAD; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MANGANESE GLUCONATE; MERCURIUS SOLUBILIS; MOLYBDENUM; NASTURTIUM OFFICINALE; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; PRASEODYMIUM; RADISH; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; SILVER; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; TIN; TRITICUM AESTIVUM WHOLE; UBIDECARENONE; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC 30; 3; 12; 12; 12; 12; 6; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 8; 3; 12; 12; 30; 12; 12; 3; 12; 12; 3; 12; 12; 12; 12; 12; 6; 12; 12; 3; 12; 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 1; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0275_5bfa27a5-f83e-45bc-ae7d-22ebdb6c1cc5 43857-0275 HUMAN OTC DRUG Acne HP not applicable LIQUID ORAL 20140804 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACTIVATED CHARCOAL; CARBO ANIMALIS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CHLORIDE; SULFUR; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0276_cea0099a-a87a-4df0-af67-ab13c66a5bca 43857-0276 HUMAN OTC DRUG Bio Rock Rose 6X, 30C, 200C not applicable LIQUID ORAL 20140805 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HELIANTHEMUM NUMMULARIUM FLOWER 6 [hp_X]/mL 43857-0277_271f3fd7-136d-4a1c-86f3-0d11434b0b29 43857-0277 HUMAN OTC DRUG PYCNOGENOL 6X not applicable LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. MARITIME PINE 6 [hp_X]/mL 43857-0279_3bc53e05-a770-47e0-88bb-93dc600256c6 43857-0279 HUMAN OTC DRUG Dopamine Dopamine hydrochloride, LIQUID ORAL 20140612 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. DOPAMINE HYDROCHLORIDE 6 [hp_X]/mL 43857-0280_b3c0596d-e189-4c2f-be4a-7696bacf1b0b 43857-0280 HUMAN OTC DRUG Endoplex M Not applicable LIQUID ORAL 20140815 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc AMERICAN GINSENG; CHASTE TREE; CLEMATIS RECTA FLOWERING TOP; JUNIPERUS VIRGINIANA TWIG; LYCOPODIUM CLAVATUM SPORE; PETROSELINUM CRISPUM; PULSATILLA VULGARIS; SAW PALMETTO; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; SUS SCROFA TESTICLE; URTICA DIOICA; ZANTHOXYLUM AMERICANUM BARK 3; 3; 12; 3; 3; 3; 3; 3; 6; 6; 6; 6; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0281_fd9f22c3-c7b1-4d11-8568-babc78063fc1 43857-0281 HUMAN OTC DRUG Cough Syrup Formula not applicable LIQUID ORAL 20140805 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; MENTHA PIPERITA; PHOSPHORUS; POTASSIUM CARBONATE; PROTORTONIA CACTI; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 12; 3; 12; 12; 12; 5; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0282_4e60d3c0-00c3-40cb-9cd9-f2d242b4c397 43857-0282 HUMAN OTC DRUG Strength F not applicable LIQUID ORAL 20140806 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. .ALPHA.-KETOGLUTARIC ACID; ARGININE; ESTRADIOL; ESTRIOL; ESTRONE; ISOLEUCINE; LEUCINE; LEVOCARNITINE; ORNITHINE; PROGESTERONE; TESTOSTERONE; VALINE 3; 6; 6; 12; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0283_aea04613-4a6f-470a-b8fb-2cc00cd7d7a5 43857-0283 HUMAN OTC DRUG Lymph III Echinacea (Angustifolia), Phytolacca decandra, Boldo, Pinus sylvestris, Thyroidinum (suis), Germanium sesquioxide, Arnica montana, Calcarea iodata, LIQUID ORAL 20140416 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; ARNICA MONTANA; CALCIUM IODIDE; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA; GERMANIUM SESQUIOXIDE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HUMAN BREAST TUMOR CELL; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); NAJA NAJA VENOM; PEUMUS BOLDUS LEAF; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; RANCID BEEF; SODIUM SULFATE; SULFUR; SUS SCROFA THYROID; TRIBASIC CALCIUM PHOSPHATE; UBIDECARENONE 12; 12; 12; 12; 1; 8; 12; 200; 30; 30; 30; 15; 3; 3; 6; 30; 30; 30; 6; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0284_6d01a462-cd62-4273-89ba-c152b6cec170 43857-0284 HUMAN OTC DRUG Androbalance DHEA (dehydroepiandrosterone) Pregnenolone, Progestertone, Testosterone SPRAY ORAL 20140224 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PRASTERONE; PREGNENOLONE; PROGESTERONE; TESTOSTERONE 6; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0285_405d2d71-c0ed-49e7-ad9d-000a911a200f 43857-0285 HUMAN OTC DRUG HA HP NOT APPLICABLE LIQUID ORAL 20140822 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; MELILOTUS OFFICINALIS TOP; NITROGLYCERIN; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0286_1e83bc29-b984-4051-abcb-e275241a0fb8 43857-0286 HUMAN OTC DRUG Osteoplex not applicable LIQUID ORAL 20140822 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ASCORBIC ACID; CALCIUM FLUORIDE; COMFREY ROOT; EQUISETUM HYEMALE; MAGNESIUM CHLORIDE; MANGANESE CHLORIDE; SILICON DIOXIDE; SUS SCROFA BONE MARROW; SUS SCROFA LIGAMENT; SUS SCROFA PARATHYROID GLAND; TRIBASIC CALCIUM PHOSPHATE 6; 12; 3; 3; 3; 6; 12; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 43857-0287_c77fdcf8-6b31-47a4-b905-46015c2b7197 43857-0287 HUMAN OTC DRUG Res Balancer not applicable SPRAY ORAL 20140818 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BOS TAURUS SPLEEN; BOS TAURUS THYMUS 8; 8 [hp_X]/mL; [hp_X]/mL 43857-0288_d7d54d41-c8d3-49fb-8c99-5a006d43b798 43857-0288 HUMAN OTC DRUG Lumbagoforce Arnica montana, Hypericum perforatum, Symphytum officinale, Gnaphalium polycephalum, Colocynthis, Formica rufa, Rhus toxicodendron, LIQUID ORAL 20140310 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; CITRULLUS COLOCYNTHIS FRUIT PULP; COMFREY ROOT; FORMICA RUFA; HYPERICUM PERFORATUM; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF 3; 12; 3; 12; 3; 5; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0289_80f39224-a79e-4bf5-b8f7-9e7b645da8a8 43857-0289 HUMAN OTC DRUG LYM D Chelidonium majus, Echinacea (angustifolia), Hydrastis canadensis, Nasturtium aquaticim, Taraxacum officinale, Trifolium pratense, Urtica dioica, LIQUID ORAL 20140331 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; BORRELIA BURGDORFERI; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; NASTURTIUM OFFICINALE; PHOSPHORUS; PROTORTONIA CACTI; SUS SCROFA THYMUS; SUS SCROFA THYROID; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA 12; 12; 3; 3; 3; 200; 12; 3; 12; 12; 8; 8; 3; 12; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0290_1425a04f-95c6-48b6-a5b7-5a6b4fda3515 43857-0290 HUMAN OTC DRUG Sinuforce Echinacea (angustifolia), Hydrastis canadensis, Nux moschata, Trigonella foenum graecum, Arsenicum album, Kali bichromicum, LIQUID ORAL 20140321 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; ECHINACEA ANGUSTIFOLIA; FENUGREEK SEED; GOLDENSEAL; MERCURIC SULFIDE; MERCURIUS SOLUBILIS; NUTMEG; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 12; 3; 3; 3; 12; 30; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0291_7bd3a4ed-6366-4c9e-9c13-2bd602f5f251 43857-0291 HUMAN OTC DRUG ASP Echinacea (Angustifolia), Hydrastis canadensis, Tabebuia impetiginosa, Glandula suprarenalis suis, Thymus(suis), Thyroidinum (suis), Arsenicum album, LIQUID ORAL 20140403 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANAMIRTA COCCULUS SEED; ARSENIC TRIOXIDE; ASPERGILLUS FLAVUS; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LEDUM PALUSTRE TWIG; MERCURIC CYANIDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; SUS SCROFA THYROID; TABEBUIA IMPETIGINOSA BARK 12; 12; 30; 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 8; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0292_f23edd26-f000-4fae-9f5b-7adc8edcee74 43857-0292 HUMAN OTC DRUG Immuno Fortifier Echinacea (Angustifolia), Hydrastis canadensis, Myrrha, Nasturtium aquaticum, OSHA, Tabebuia impetiginosa, Trigonella foenum-graecum, Ascorbic acid, LIQUID ORAL 20140424 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ASCORBIC ACID; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA; FENUGREEK SEED; GOLDENSEAL; LIGUSTICUM PORTERI ROOT; MYRRH; NASTURTIUM AQUATICUM; PHOSPHORIC ACID; PINUS SYLVESTRIS LEAFY TWIG; SILICON DIOXIDE; SUS SCROFA BONE MARROW; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK 6; 12; 3; 3; 3; 3; 3; 3; 12; 6; 12; 8; 8; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0293_32aba695-a888-4f61-b874-63e74eb96402 43857-0293 HUMAN OTC DRUG FNG I Echinacea (Angustifolia), Hydrastis canadensis, Lomatium dissectum, Nasturtium aquaticum, Tabebuia impetiginosa, Condurango, Ginko biloba, Ligusticum porteri, LIQUID ORAL 20140424 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; ASTRAGALUS PROPINQUUS ROOT; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BOS TAURUS ADRENAL GLAND; BOS TAURUS THYMUS; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA ANGUSTIFOLIA; GINKGO; GOLDENSEAL; LIGUSTICUM PORTERI ROOT; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MARSDENIA CONDURANGO BARK; MUCOR RACEMOSUS; NASTURTIUM OFFICINALE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PROPOLIS WAX; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; TABEBUIA IMPETIGINOSA BARK 12; 12; 6; 12; 8; 8; 12; 12; 3; 4; 3; 4; 3; 12; 4; 12; 3; 12; 12; 6; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0294_ad4a4439-91bb-4c45-839c-94c598acc4b9 43857-0294 HUMAN OTC DRUG Lymphoplex Myrrha, Trigonella foenum-graecum, Pinus sylvestris, Lymph (suis), Spleen (suis), Conium maculatum, Echinacea (Angustifolia), Hepar sulphuris calcareum, LIQUID ORAL 20140425 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; FENUGREEK SEED; HYDRANGEA ARBORESCENS ROOT; MYRRH; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; SILICON DIOXIDE; SUS SCROFA LYMPH; SUS SCROFA SPLEEN 12; 12; 12; 3; 12; 3; 12; 6; 12; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0295_e5b36436-42b6-486a-a822-302c37e68a6f 43857-0295 HUMAN OTC DRUG EAR not applicable LIQUID ORAL 20140818 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BAPTISIA TINCTORIA ROOT; CAPSICUM; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; GOLDENSEAL; MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; POTASSIUM CHLORIDE; PULSATILLA VULGARIS 3; 12; 3; 12; 3; 12; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0296_0edf49de-a31d-4f6d-9297-ab3c03d1cd29 43857-0296 HUMAN OTC DRUG Sinus Tonic Echinacea (Angustifolia), Baptisia tinctoria, Hydrastis canadensis, Thiaminum hydrochloricum, Pyridoxinum hydrochloricum, Spongia tosta, Apis mellifica, LIQUID ORAL 20140508 UNAPPROVED MEDICAL GAS BioActive Nutritional, Inc. APIS MELLIFERA; ASCORBIC ACID; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LACHESIS MUTA VENOM; MERCURIC IODIDE; MERCURIC SULFIDE; PANTOTHENIC ACID; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; SILICON DIOXIDE; SINUSITISINUM; SPONGIA OFFICINALIS SKELETON, ROASTED; THIAMINE HYDROCHLORIDE 12; 12; 3; 12; 2; 3; 12; 12; 12; 28; 12; 12; 6; 12; 30; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0298_98ffa99c-2f86-46a1-9ac1-a379d260c2c8 43857-0298 HUMAN OTC DRUG EVTOX Cochlearia officinalis, Echinacea (Angustifolia), Hydrastis canadensis, Lomatium dissectum, Tabebuia impetiginosa, Propolis, Glandula suprarenalis suis, LIQUID ORAL 20140502 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARANEUS DIADEMATUS; COCHLEARIA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HUMAN HERPESVIRUS 4; HYDROCHLORIC ACID; IPECAC; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PROPOLIS WAX; SILICON DIOXIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; TOXICODENDRON PUBESCENS LEAF 12; 3; 3; 3; 30; 12; 12; 3; 12; 12; 6; 12; 8; 8; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0299_0f765c13-16fa-451e-bcf8-d46e9650986d 43857-0299 HUMAN OTC DRUG Edema HP Apis mellifica, Arsenicum album, Digitalis purpurea, Ferrum metallicum, Lycopodium clavatum, Rhus toxicodendron, Sambucus nigra, Strophanthus hispidus, LIQUID ORAL 20140603 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; DIGITALIS; IRON; LYCOPODIUM CLAVATUM SPORE; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0300_fb014f8b-9f7a-43a9-93c7-fefed558e35d 43857-0300 HUMAN OTC DRUG Cardiotone Adonis vernalis, ATP (Adenosine triphosphate), Cactus grandiflorus, Co-enzyme Q-10, Convallaria majalis, Heart (suis), Magnesium gluconate, Potassium gluconate, LIQUID ORAL 20140604 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ADENOSINE TRIPHOSPHATE; ADONIS VERNALIS; CONVALLARIA MAJALIS; DIGITALIS; GERMANIUM SESQUIOXIDE; MAGNESIUM GLUCONATE; PORK HEART; POTASSIUM GLUCONATE; SELENICEREUS GRANDIFLORUS STEM; STROPHANTHUS HISPIDUS SEED; SUS SCROFA THYROID; UBIDECARENONE 6; 3; 6; 12; 8; 6; 6; 6; 6; 10; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0301_8dc6ed3c-919b-4055-a509-04815065e652 43857-0301 HUMAN OTC DRUG V HP Arsenicum album, Belladonna, Echinacea (Angustifolia), Eupatorium perfoliatum, Gelsemium sempervirens, Lycopodium clavatum, Phosphoricum acidum, Phosphorus, LIQUID ORAL 20140522 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC ACID; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0302_7a62b65f-ca27-4de4-bb7a-1b4be4e5d603 43857-0302 HUMAN OTC DRUG Virotox Echinacea (Angustifolia), Hydrastis canadensis, Lomatium dissectum, Myrrha, Nasturtium aquaticum, Tabebuia impetginosa, LIQUID ORAL 20140603 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA; BOS TAURUS THYMUS; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MYRRH; NASTURTIUM AQUATICUM; RANCID BEEF; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; TABEBUIA IMPETIGINOSA BARK 12; 8; 3; 12; 3; 3; 12; 3; 3; 30; 12; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0303_bf98560a-0dd8-46d9-9e2b-6ec4774bce48 43857-0303 HUMAN OTC DRUG CANDIDA ALB 60X Candida Albicans LIQUID ORAL 20140702 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CANDIDA ALBICANS 60 [hp_X]/mL 43857-0304_b5cf59c3-9380-49bc-acf7-5a7cbfc764b0 43857-0304 HUMAN OTC DRUG Lymph II Echinacea (Angustifolia), Phytolacca decandra, Collinsonia canadensis, Kali iodatum, Pinus sylvestris, Pix liquida, Ferrum phosphoricum, Aesculus hippocastanum, Baryta carbonica, LIQUID ORAL 20140621 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BUFO BUFO CUTANEOUS GLAND; CALCIUM SULFIDE; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; HORSE CHESTNUT; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PINE TAR; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM IODIDE; PULSATILLA VULGARIS; SILICON DIOXIDE; SODIUM CHLORIDE; STELLARIA MEDIA; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TRIBASIC CALCIUM PHOSPHATE; TURPENTINE OIL; WOOD CREOSOTE 12; 12; 12; 12; 12; 3; 3; 8; 12; 12; 12; 12; 12; 12; 3; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0305_b946fc67-4c82-467c-a863-a6822ba77296 43857-0305 HUMAN OTC DRUG Bio Gentian 6X, 30C, 200C Gentianella Amarella, Flos LIQUID ORAL 20140703 UNAPPROVED HOMEOPATHIC BioActive Nutritional Inc . GENTIANELLA AMARELLA FLOWER 6 [hp_X]/mL 43857-0306_c8eee778-2e32-494d-8395-97c703ba6980 43857-0306 HUMAN OTC DRUG Bio Hornbeam 6X, 30C, 200C Carpinus Betulus, Flos LIQUID ORAL 20140703 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CARPINUS BETULUS FLOWERING TOP 6 [hp_X]/mL 43857-0307_bb00c02f-3677-4971-9ae3-417c133a71b5 43857-0307 HUMAN OTC DRUG Bio Scleranthus 6X, 30C, 200C Scleranthus Annuus, Flos LIQUID ORAL 20140703 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SCLERANTHUS ANNUUS FLOWERING TOP 6 [hp_X]/mL 43857-0308_94236747-10c8-4295-a7ea-b0b710c2eaca 43857-0308 HUMAN OTC DRUG Bio Gorse 6X, 30C, 200C Ulex Europaeus, Flos LIQUID ORAL 20140703 UNAPPROVED HOMEOPATHIC BioActive Nutritional Inc. ULEX EUROPAEUS FLOWER 6 [hp_X]/mL 43857-0309_af598836-447c-4fed-828f-acefb47c9e29 43857-0309 HUMAN OTC DRUG Histamine 6X Histaminum Hydrochloricum LIQUID ORAL 20140707 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HISTAMINE DIHYDROCHLORIDE 30 [hp_X]/mL 43857-0310_8338e1b2-a72e-4ee6-85be-370e8b228463 43857-0310 HUMAN OTC DRUG Adrenoplex Echinacea (Angustifolia), Adrenalinum, Glandula suprarenalis bovine, Spleen (suis), Carduus marianus, Lycopodium clavatum, LIQUID ORAL 20140708 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BOS TAURUS ADRENAL GLAND; ECHINACEA ANGUSTIFOLIA; EPINEPHRINE; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; PHOSPHORIC ACID; SODIUM CHLORIDE; SUS SCROFA SPLEEN 8; 3; 8; 12; 12; 12; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0311_f344d32e-99f5-4904-9e72-cc10c54d6eb9 43857-0311 HUMAN OTC DRUG Systemic Detox not applicable LIQUID ORAL 20140722 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALOE; ARCTIUM LAPPA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GINKGO; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MARSDENIA CONDURANGO BARK; PEUMUS BOLDUS LEAF; SANGUINARIA CANADENSIS ROOT; SMILAX REGELII ROOT; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TABEBUIA IMPETIGINOSA BARK; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TRIFOLIUM PRATENSE FLOWER 30; 3; 3; 12; 12; 30; 6; 3; 12; 6; 3; 3; 12; 30; 30; 6; 3; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0312_5152e764-d777-4523-bb69-f146900a9ad3 43857-0312 HUMAN OTC DRUG Toxodetox Toxoplasma Gondii LIQUID ORAL 20140711 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. TOXOPLASMA GONDII 12 [hp_X]/mL 43857-0313_ca8c808b-0f81-44f6-8dc1-d0fd0bd111bb 43857-0313 HUMAN OTC DRUG HZ Formula Baptisia Tinctoria, Echinacea (Angustifolia), Lomatium Dissectum, Tabebuia Impetiginosa, Propolis, Spleen(suis), Thymus(suis), Throidinum(Suis), Gelsemium Sempervirens LIQUID ORAL 20140711 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc BAPTISIA TINCTORIA; CANDIDA ALBICANS; CHLAMYDIA TRACHOMATIS; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN PAPILLOMAVIRUS; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; PROPOLIS WAX; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; THYROID, PORCINE; TRICHINELLA SPIRALIS 3; 30; 30; 3; 12; 30; 30; 30; 3; 12; 6; 12; 6; 6; 3; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0314_a66c597b-7fbb-4242-bb10-bf3e3f7b297c 43857-0314 HUMAN OTC DRUG PMS Angelica Archangelica, Cimicifuga Racemosa, Fucus Vesiculosus, Hypothalamus (suis), Magnesia Gluconate, Oophorinum (suis) Pyridoxinum Hydrochloricum, Bovista, Cuprum metallicum, Sepia, Zincum Metallicum, Lachesis Mutus LIQUID ORAL 20140714 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANGELICA ARCHANGELICA ROOT; BLACK COHOSH; COPPER; FUCUS VESICULOSUS; LACHESIS MUTA VENOM; LYCOPERDON UTRIFORME FRUITING BODY; MAGNESIUM GLUCONATE; PYRIDOXINE HYDROCHLORIDE; SEPIA OFFICINALIS JUICE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; ZINC 3; 3; 12; 3; 15; 12; 6; 6; 12; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0315_b64a1d36-471f-43e5-8cc8-6e8cd059db30 43857-0315 HUMAN OTC DRUG SEPTAFORCE Baptisia Tinctoria, Echinacea (Angustifolia), Arsenicum Album, Chininum Sulphuricum, Crotalus Horridus, Lachesis Mutus, Loxosceles Reclusa, Secale Cornutum, Tarentula Cubensis LIQUID ORAL 20140711 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA; CITHARACANTHUS SPINICRUS; CLAVICEPS PURPUREA SCLEROTIUM; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LOXOSCELES RECLUSA; QUININE SULFATE 12; 33; 3; 12; 12; 12; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0316_3a1b5927-0652-4b0e-afe0-6065ac1a68d4 43857-0316 HUMAN OTC DRUG Drainage Echinacea (Augustifolia), Phytolacca Decandra, Trifolium Pratense, Calcarea Iodata, Kali Muriaticum, Nitricum Acidum, Phosphoricum Acidum, Sulphur Iodatum LIQUID ORAL 20140715 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CALCIUM IODIDE; ECHINACEA ANGUSTIFOLIA; NITRIC ACID; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; POTASSIUM CHLORIDE; SULFUR IODIDE; TRIFOLIUM PRATENSE FLOWER 12; 3; 12; 12; 3; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0317_38b5d11b-8a09-42ae-97ba-02e812035ac9 43857-0317 HUMAN OTC DRUG FNG II Echinacea (Angustifolia), Hydrastis Canadensis, Lomatium Dissectum, Nasturtium Aquaticum, Tabebuia Impetiginosa, Iodium, Adrenalinum, Thymus (suis), Throidinum (suis) LIQUID ORAL 20140715 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CANDIDA ALBICANS; ECHINACEA ANGUSTIFOLIA; EPINEPHRINE; GOLDENSEAL; IODINE; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; NASTURTIUM AQUATICUM; PHOSPHORIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILVER; SUS SCROFA THYMUS; SUS SCROFA THYROID; TABEBUIA IMPETIGINOSA BARK 12; 3; 8; 3; 6; 3; 30; 3; 12; 30; 30; 8; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0319_3c933df3-3e01-490d-a9a1-88a0cb89f6bb 43857-0319 HUMAN OTC DRUG LIVER TONIC I not applicable LIQUID ORAL 20140716 UNAPPROVED HOMEOPATHIC BioActive, Inc. BEEF LIVER; CEANOTHUS AMERICANUS LEAF; CHIONANTHUS VIRGINICUS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; PHOSPHORUS; QUASSIA AMARA WOOD; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TEUCRIUM MARUM; VERONICASTRUM VIRGINICUM ROOT 8; 12; 3; 12; 1; 1; 12; 3; 12; 12; 1; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0320_131bf6a3-85fd-4a16-94e5-4fb7d9d70c30 43857-0320 HUMAN OTC DRUG Arterioforce II Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Phytolacca Decandra. Myrrha, Nasturtium Aquaticum, Trigonella Foenum-graecum, Kali Iodatum LIQUID ORAL 20140715 UNAPPROVED HOMEOPATHIC Bio Active Nutritional, Inc. ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; FENUGREEK SEED; GOLDENSEAL; MYRRH; NASTURTIUM AQUATICUM; PHYTOLACCA AMERICANA ROOT; POTASSIUM IODIDE; PROPOLIS WAX; SELENICEREUS GRANDIFLORUS STEM 6; 3; 12; 12; 12; 3; 4; 3; 4; 4; 3; 5; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0321_aa643df9-0439-4f6f-91d2-ba9cf8029cb1 43857-0321 HUMAN OTC DRUG Cardioforce II not applicable LIQUID ORAL 20140718 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc ARTEMISIA ABROTANUM FLOWERING TOP; BELLIS PERENNIS; BLACK COHOSH; CONVALLARIA MAJALIS; MAGNESIUM SULFATE HEPTAHYDRATE; NERIUM OLEANDER LEAF; PEUMUS BOLDUS LEAF; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; TARAXACUM OFFICINALE 3; 30; 3; 3; 5; 8; 3; 3; 12; 3 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0322_37ae9b3e-670f-45bd-98ad-d71929affcb5 43857-0322 HUMAN OTC DRUG LYM D not applicable LIQUID ORAL 20140723 UNAPPROVED HOMEOPATHIC BioActive Nutritional Inc. ARSENIC TRIOXIDE; BORRELIA BURGDORFERI; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; NASTURTIUM OFFICINALE; PHOSPHORUS; PROTORTONIA CACTI; SANGUINARIA CANADENSIS ROOT; SUS SCROFA THALAMUS; SUS SCROFA THYROID; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA 12; 12; 3; 3; 200; 12; 3; 12; 12; 3; 8; 8; 3; 12; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0323_e7b31997-1402-455f-b91c-8c71ea0c9d56 43857-0323 HUMAN OTC DRUG Bio Chem Detox not applicable SPRAY ORAL 20140731 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACONITUM NAPELLUS; ACTIVATED CHARCOAL; AMANITA MUSCARIA FRUITING BODY; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; NITRIC ACID; PHOSPHORIC ACID; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED; PHYTOLACCA AMERICANA ROOT; PORK LIVER; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA THYROID; TOBACCO LEAF; TRIFOLIUM PRATENSE FLOWER; TRITICUM AESTIVUM WHOLE; TUBOCURARINE CHLORIDE; ZANTHOXYLUM AMERICANUM BARK 12; 12; 30; 3; 12; 12; 3; 12; 12; 3; 3; 30; 12; 12; 12; 12; 12; 30; 3; 6; 3; 12; 12; 6; 6; 6; 12; 3; 3; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 43857-0324_29842920-4e27-48a7-b7a4-576ae3d1d07d 43857-0324 HUMAN OTC DRUG BIO WILD ROSE NOT APPLICABLE LIQUID ORAL 20140925 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ROSA ARKANSANA ROOT 6 [hp_X]/mL 43857-0325_598c2576-5a47-418c-bb8b-eac1b41914dc 43857-0325 HUMAN OTC DRUG CVTOX not applicable LIQUID ORAL 20140804 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARANEUS DIADEMATUS; BOS TAURUS ADRENAL GLAND; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HEPATITIS B VIRUS; HORSERADISH; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4; HUMAN HERPESVIRUS 3; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 5; HYDROCHLORIC ACID; IPECAC; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MEASLES VIRUS; NITRIC ACID; PHOSPHORIC ACID; POLIOVIRUS; PROPOLIS WAX; SILICON DIOXIDE; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; TOXICODENDRON PUBESCENS LEAF 12; 8; 3; 3; 33; 3; 15; 15; 30; 30; 30; 12; 12; 3; 12; 30; 12; 12; 30; 6; 12; 8; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0326_dd55d72b-2908-4273-8b33-22515ba0cfd4 43857-0326 HUMAN OTC DRUG Diathesis IV not applicable LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. .ALPHA.-KETOGLUTARIC ACID; BOS TAURUS BILE; COPPER; CYSTEINE; FUMARIC ACID; GERMANIUM SESQUIOXIDE; GINKGO; GOLD; MANGANESE GLUCONATE; MERCURIUS SOLUBILIS; PHOSPHORIC ACID; PORK KIDNEY; SILVER; SODIUM DIETHYL OXALACETATE; STRYCHNOS NUX-VOMICA SEED 12; 5; 9; 9; 12; 8; 6; 9; 10; 12; 12; 6; 9; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0327_0800a9d3-2ab3-4453-b164-90f003e5a6f4 43857-0327 HUMAN OTC DRUG Bio Water Violet not applicable LIQUID ORAL 20140828 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HOTTONIA PALUSTRIS FLOWER 6 [hp_X]/mL 43857-0328_bcac39aa-420d-410a-a422-7cd0b272737f 43857-0328 HUMAN OTC DRUG Liver Tonic II not applicable LIQUID ORAL 20140825 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMMI VISNAGA FRUIT; ATROPINE SULFATE; BEEF LIVER; BOS TAURUS GALLBLADDER; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MILK THISTLE; PEUMUS BOLDUS LEAF; PODOPHYLLUM RESIN; TARAXACUM OFFICINALE; TURMERIC; VERONICASTRUM VIRGINICUM ROOT 12; 12; 8; 8; 12; 1; 8; 1; 1; 12; 1; 1; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0330_6af8e25e-496d-4632-8663-218422023cd4 43857-0330 HUMAN OTC DRUG Renotox not applicable LIQUID ORAL 20140826 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AGATHOSMA BETULINA LEAF; ALUMINUM; ANTIMONY TRISULFIDE; ARCTOSTAPHYLOS UVA-URSI LEAF; ARSENIC TRIOXIDE; ASPARAGUS; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BERYLLIUM; BISMUTH; BORON; BOTULINUM TOXIN TYPE A; BROMINE; BRYONIA ALBA ROOT; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; CLOSTRIDIUM PERFRINGENS; COBALT; COPPER; DYSPROSIUM; ECHINACEA ANGUSTIFOLIA; ERBIUM; ESCHERICHIA COLI; EUROPIUM OXIDE; EUTROCHIUM PURPUREUM ROOT; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; HUMAN HERPESVIRUS 4; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); IRIDIUM; IRON; LANTHANUM OXIDE; LEAD; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MEASLES VIRUS; MERCURIC CHLORIDE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PETROSELINUM CRISPUM; PLATINUM; POLIOVIRUS; PORK KIDNEY; POTASSIUM CHLORIDE; PRASEODYMIUM; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; RHODIUM; RUBIDIUM; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SAMARIUM OXIDE; SAW PALMETTO; SELENIUM; SILVER; SOLIDAGO VIRGAUREA FLOWERING TOP; STRONTIUM CARBONATE; TANTALUM; TARAXACUM OFFICINALE; TERBIUM; THALLIUM; TIN; TRITICUM AESTIVUM WHOLE; URANYL NITRATE HEXAHYDRATE; VANADIUM; YERSINIA ENTEROCOLITICA; YTTERBIUM OXIDE; ZINC 3; 12; 12; 3; 12; 3; 12; 3; 12; 12; 12; 30; 12; 12; 12; 12; 12; 12; 15; 12; 12; 12; 3; 12; 30; 12; 6; 12; 12; 12; 12; 30; 30; 30; 30; 12; 12; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 12; 12; 12; 3; 12; 30; 8; 3; 12; 30; 30; 12; 12; 33; 12; 3; 12; 12; 3; 12; 12; 3; 12; 12; 12; 1; 12; 12; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0331_fd7cfde0-27b9-4933-9c91-965c78dd9c3e 43857-0331 HUMAN OTC DRUG ADRENOPLEX NOT APPLICABLE LIQUID ORAL 20140902 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BOS TAURUS ADRENAL GLAND; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; PHOSPHORIC ACID; SODIUM CHLORIDE; SUS SCROFA SPLEEN 8; 3; 3; 12; 12; 12; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0332_832709f8-22b7-42cb-b63c-12b3eacb9a03 43857-0332 HUMAN OTC DRUG Albuminuriaforce NOT APPLICABLE LIQUID ORAL 20140903 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; EQUISETUM HYEMALE; MERCURIC CHLORIDE; NUTMEG; PHOSPHORUS; SOLIDAGO VIRGAUREA FLOWERING TOP; TURPENTINE OIL 12; 3; 12; 12; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0333_a6e83bf3-4823-4f6f-a22f-ac4b4686fc51 43857-0333 HUMAN OTC DRUG Female Tonic NOT APPLICABLE LIQUID ORAL 20140902 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; ASTERIAS RUBENS; CALCIUM FLUORIDE; CANIS LUPUS FAMILIARIS MILK; CAULOPHYLLUM THALICTROIDES ROOT; CHASTE TREE; CONIUM MACULATUM FLOWERING TOP; CYCLAMEN PURPURASCENS TUBER; HOPS; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; MARSDENIA CONDURANGO BARK; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED 12; 6; 12; 12; 3; 3; 12; 15; 1; 3; 12; 3; 1; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0334_74e72cd3-1c01-4cd5-a214-95ea1a66b141 43857-0334 HUMAN OTC DRUG Hepatatox NOT APPLICABLE LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc ACETIC ACID; BENZOIC ACID; BENZYL ALCOHOL; BORIC ACID; CHELIDONIUM MAJUS; CHLORINE; CORTICOTROPIN; CORTISONE ACETATE; ESTRONE; EUGENOL; GLUTATHIONE; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LEAD; LYCOPODIUM CLAVATUM SPORE; PETROLATUM; PHENYLBUTAZONE; PHOSPHORIC ACID; PORK LIVER; POTASSIUM SORBATE; RESORCINOL; SALICYLIC ACID; SORBITOL; STEARYL ALCOHOL; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA THYROID; TARAXACUM OFFICINALE; TRITICUM AESTIVUM WHOLE; XYLITOL 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 6; 30; 30; 30; 12; 30; 30; 12; 8; 30; 30; 30; 30; 30; 12; 8; 3; 1; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0335_152e26ad-f9a8-45c3-8c44-5a8c51cf3d4c 43857-0335 HUMAN OTC DRUG Flu Tonic NOT APPLICABLE LIQUID ORAL 20140911 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARCTOSTAPHYLOS UVA-URSI LEAF; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GINKGO; LACHESIS MUTA VENOM; MARSDENIA CONDURANGO BARK; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM CHLORIDE; SELENIUM; TABEBUIA IMPETIGINOSA BARK; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP 1; 3; 12; 6; 12; 1; 12; 12; 12; 6; 6; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0336_89a000be-ceac-4a6f-8d12-a1d009b4a7e4 43857-0336 HUMAN OTC DRUG INDUSTROTOX NOT APPLICABLE LIQUID ORAL 20141003 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARCTIUM LAPPA ROOT; ARNICA MONTANA; ASCLEPIAS TUBEROSA ROOT; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; EUCALYPTUS GLOBULUS LEAF; FENUGREEK SEED; FRANGULA ALNUS BARK; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; NASTURTIUM OFFICINALE; NITRIC ACID; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; PORK LIVER; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA LUNG; SUS SCROFA LYMPH; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA; ZANTHOXYLUM AMERICANUM BARK 4; 3; 4; 12; 4; 4; 4; 3; 4; 4; 4; 4; 4; 3; 12; 4; 4; 12; 12; 4; 3; 8; 3; 12; 8; 8; 4; 3; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0337_4e612b34-6d17-4dd6-bce4-1290618e0cf9 43857-0337 HUMAN OTC DRUG Metalogin NOT APPLICABLE LIQUID ORAL 20140818 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALUMINUM; ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; FRANGULA ALNUS BARK; GADOLINIUM OXIDE; GARLIC; GERMANIUM SESQUIOXIDE; GLYCYRRHIZA GLABRA; GOLD; HOLMIUM; IRIDIUM; IRON; LANTHANUM OXIDE; LEAD; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; METHIONINE; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PHYTOLACCA AMERICANA ROOT; PLATINUM; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; SELENIUM DIOXIDE; SILVER; STILLINGIA SYLVATICA ROOT; STRONTIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA THYROID; TANTALUM; TERBIUM; THALLIUM; TIN; TRIFOLIUM PRATENSE FLOWER; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC 12; 12; 3; 12; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 3; 12; 3; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 6; 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 12; 12; 8; 12; 3; 12; 12; 6; 12; 12; 12; 12; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0338_da5554bc-a0c4-458a-9dea-d97da0943111 43857-0338 HUMAN OTC DRUG PSORIAFORCE NOT APPLICABLE LIQUID ORAL 20141015 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARCTIUM LAPPA ROOT; ARSENIC TRIIODIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; CLEMATIS RECTA FLOWERING TOP; DAPHNE MEZEREUM BARK; ECHINACEA ANGUSTIFOLIA; FRANGULA ALNUS BARK; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; GOLDENSEAL; GRAPHITE; KEROSENE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SEPIA OFFICINALIS JUICE; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK 3; 12; 3; 3; 12; 12; 3; 3; 3; 3; 3; 12; 12; 12; 3; 12; 12; 12; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0339_1b60de8a-3cec-47fc-821f-7981e4e7e174 43857-0339 HUMAN OTC DRUG SILICEA COMPLEX II NOT APPLICABLE LIQUID ORAL 20141015 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CALCIUM IODIDE; DIMETHICONE; ECHINACEA ANGUSTIFOLIA; NITRIC ACID; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; POTASSIUM CHLORATE; SULFUR IODIDE; TRIFOLIUM PRATENSE FLOWER 12; 12; 3; 12; 12; 3; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0340_ad938a0c-9cf0-4858-b00a-d76cb54815d8 43857-0340 HUMAN OTC DRUG RENAFORCE NOT APPLICABLE LIQUID ORAL 20141015 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; POTASSIUM CHLORIDE; PROTORTONIA CACTI 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0341_e25890de-0254-4afd-b53a-8af35a83c0c0 43857-0341 HUMAN OTC DRUG VARICO HP NOT APPLICABLE LIQUID ORAL 20141020 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACTIVATED CHARCOAL; CALCIUM FLUORIDE; CLAVICEPS PURPUREA SCLEROTIUM; DELPHINIUM STAPHISAGRIA SEED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0343_5b3e9f56-71aa-4912-ac16-d6effeec9c96 43857-0343 HUMAN OTC DRUG DV HP NOT APPLICABLE LIQUID ORAL 20141125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; DYSPHANIA AMBROSIOIDES; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0345_3af1c6a7-96d7-44ac-b7df-b6736a2ec581 43857-0345 HUMAN OTC DRUG LIVER TONIC I NOT APPLICABLE LIQUID ORAL 20141125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BEEF LIVER; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; MILK THISTLE; PHOSPHORUS; QUASSIA AMARA WOOD; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TEUCRIUM MARUM; VERONICASTRUM VIRGINICUM ROOT 8; 12; 1; 3; 12; 1; 12; 3; 12; 12; 1; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0346_7c2ea190-74de-4a7b-9a9d-a0e0e501c9b6 43857-0346 HUMAN OTC DRUG ENERGIZER PHOSPHORICUM ACIDUM, COCCULUS INDICUS, HELONIAS DIOICA, IGNATIA AMARA, SEPIA, ZINCUM METALLICUM LIQUID ORAL 20141216 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANAMIRTA COCCULUS SEED; CHAMAELIRIUM LUTEUM ROOT; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; ZINC 6; 6; 4; 12; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0347_ac882809-fe9c-440d-ac0c-46ff1128f90c 43857-0347 HUMAN OTC DRUG PHLORIDZIN NOT APPLICABLE LIQUID ORAL 20141119 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PHLORIZIN 6 [hp_X]/mL 43857-0349_cf1271b1-c358-405c-b0ab-aca148825137 43857-0349 HUMAN OTC DRUG LYM D CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, NASTURTIUM AQUATICUM, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE LIQUID ORAL 20141202 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; BORRELIA BURGDORFERI; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; NASTURTIUM OFFICINALE; PHOSPHORUS; PROTORTONIA CACTI; SUS SCROFA THYMUS; TARAXACUM OFFICINALE; THYROID, PORCINE; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA 12; 12; 3; 3; 3; 200; 12; 3; 12; 12; 8; 3; 8; 12; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0350_904424ba-9abf-4c77-89d2-ade2e33d42b3 43857-0350 HUMAN OTC DRUG BIO CLEMATIS CLEMATIS VITALBA FLOWER LIQUID ORAL 20141204 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CLEMATIS VITALBA FLOWER 6 [hp_X]/mL 43857-0351_19d33409-9f33-42f9-a402-9675faa176d5 43857-0351 HUMAN OTC DRUG Osteoforce MEDULLA OSSIS SUIS, CALCAREA CARBONICA, CALCAREA FLUORICA, CAUSTICUM, COCCULUS INDICUS, LEDUM PALUSTRE LIQUID ORAL 20141204 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANAMIRTA COCCULUS SEED; CALCIUM FLUORIDE; CAUSTICUM; LEDUM PALUSTRE TWIG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; SUS SCROFA BONE MARROW; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43857-0352_44af734f-d81e-4468-8120-9d3c86495e1f 43857-0352 HUMAN OTC DRUG BIO CRAB APPLE CRAB APPLE LIQUID ORAL 20141215 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. MALUS SYLVESTRIS FLOWER 6 [hp_X]/mL 43861-1013_0da5092d-d845-442a-9cee-fceaa3813e68 43861-1013 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS INTRAGASTRIC 19770101 UNAPPROVED MEDICAL GAS Sexton Weldilng Supply Co., Inc. CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 43861-1066_46bfcc84-82f7-4c58-bb7f-2d9df93d9ad2 43861-1066 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19710101 UNAPPROVED MEDICAL GAS Sexton Weldilng Supply Co., Inc. NITROGEN 99 L/100L 43861-1930_a46c0731-b472-4f13-b034-a2e4fd59b3fa 43861-1930 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19710101 UNAPPROVED MEDICAL GAS Sexton Weldilng Supply Co., Inc. OXYGEN 99 L/100L 43913-404_2dfe9515-b626-41d6-a129-5054814af76f 43913-404 HUMAN OTC DRUG G-Tuss-NL Dextromethorphan Hydrobromide, Guaifenesin, and Pseudoephedrine Hydrochloride LIQUID ORAL 20140211 OTC MONOGRAPH FINAL part341 McLaren Medical DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 200; 30 mg/5mL; mg/5mL; mg/5mL 43913-405_fd524b39-a374-4991-8388-9a8554d9d844 43913-405 HUMAN OTC DRUG G-Con-X Dexbrompheniramine Maleate and Pseudoephedrine Hydrochloride LIQUID ORAL 20140211 OTC MONOGRAPH FINAL part341 McLaren Medical DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 30 mg/5mL; mg/5mL 43913-406_bdcee84a-2613-400a-a813-8ba860ed66c0 43913-406 HUMAN OTC DRUG G-Tuss-NL Ped Dextromethorphan Hydrobromide, Guaifenesin, and Pseudoephedrine Hydrochloride LIQUID ORAL 20140211 OTC MONOGRAPH FINAL part341 McLaren Medical DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 50; 15 mg/5mL; mg/5mL; mg/5mL 43913-407_689b0cc1-a239-4ead-95be-e59de8951f61 43913-407 HUMAN OTC DRUG G-Xpect PSE Dextromethorphan Hydrobromide, Guaifenesin, and Pseudoephedrine Hydrochloride LIQUID ORAL 20140211 OTC MONOGRAPH FINAL part341 McLaren Medical DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 200; 30 mg/5mL; mg/5mL; mg/5mL 43948-1101_fbfc1668-b5bc-44f5-af5e-3988a99802ed 43948-1101 HUMAN OTC DRUG Dr. Young 2P Pearl Brightening Balm SPF35 PA ALLANTOIN CREAM TOPICAL 20120927 OTC MONOGRAPH FINAL part347 The Doctors Cosmetics Co., Ltd ALLANTOIN .5 mg/100mL 43948-1201_6bcf7913-61ad-4c9b-ac76-e3a49657f25f 43948-1201 HUMAN OTC DRUG AC Out Spot stOp Serum SALICYLIC ACID LIQUID TOPICAL 20120927 UNAPPROVED DRUG OTHER The Doctors Cosmetics Co., Ltd SALICYLIC ACID .1 mg/100mL 43948-3001_617514a3-4b2a-47d3-8f9b-f3a9b1d6d3b3 43948-3001 HUMAN OTC DRUG Dr G deWrinkle BOOSTER ample by EGF ADENOSINE GLYCERIN SOLUTION/ DROPS TOPICAL 20091101 OTC MONOGRAPH FINAL part347 The Doctor's Cosmetic Inc ADENOSINE; GLYCERIN .04; .5 mL/10mL; mL/10mL 43948-3002_35872097-4626-45cd-a1a8-2e62b0117108 43948-3002 HUMAN OTC DRUG Dr G deWrinkle FORTIFIER by EGF ADENOSINE GLYCERIN CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part347 The Doctor's Cosmetic Inc ADENOSINE; GLYCERIN .012; 2.1 mL/30mL; mL/30mL 43948-3003_0eb7cdbf-5615-48d9-b047-9edf8611b89a 43948-3003 HUMAN OTC DRUG Dr G deWrinkle REFORMER by EGF ADENOSINE DIMETHICONE CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part347 The Doctor's Cosmetic Inc ADENOSINE; DIMETHICONE .02; .35 mL/50mL; mL/50mL 43948-4001_cebf131b-e264-4eea-ab8a-f6ed573968d2 43948-4001 HUMAN OTC DRUG Dr G Whitening FORTIFIER by EGF ARBUTIN GLYCERIN CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part347 The Doctor's Cosmetic Inc ARBUTIN; GLYCERIN .6; 3 mL/30mL; mL/30mL 43948-4002_d9290e62-272d-417d-880d-ab29790125d2 43948-4002 HUMAN OTC DRUG Dr G Whitening REFORMER by EGF ARBUTIN DIMETHICONE CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part347 The Doctor's Cosmetic Inc ARBUTIN; DIMETHICONE 1; 2 mL/50mL; mL/50mL 43948-5001_7dc42f89-3624-47b8-9092-a89408e467ec 43948-5001 HUMAN OTC DRUG Dr Young 2p Blemish Base SPF35 PA ALLANTOIN CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part347 The Doctor's Cosmetic Inc ALLANTOIN 3.6 mL/60mL 43948-5002_e037669b-3a11-4a65-8cb1-b32ca6f822f5 43948-5002 HUMAN OTC DRUG Dr Young 2p Brightening UV Sun Block SPF50 PA ARBUTIN CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part352 The Doctor's Cosmetic Inc ARBUTIN .5 mL/50mL 43948-5003_0a5ab7a7-8dff-4daf-a586-0689e0b29f6c 43948-5003 HUMAN OTC DRUG Dr Young 2p Brightening UV Sun Block SPF50 PA ARBUTIN, ETHYLHEXYL METHOXYCINNAMATE CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part352 The Doctor's Cosmetic Inc ARBUTIN; OCTINOXATE .5; 2.5 mL/50mL; mL/50mL 43948-6001_5ecf591f-8090-430f-8a18-eed1909b3d26 43948-6001 HUMAN OTC DRUG High Protection Sun Air Spray SPF50 PA OCTINOXATE OCTISALATE ALUMINUM HYDROXIDE SPRAY TOPICAL 20091101 OTC MONOGRAPH FINAL part352 The Doctor's Cosmetic Inc OCTINOXATE 9.75 mL/130mL 43948-7001_5be89c26-9877-40d5-910d-16f73be10ebd 43948-7001 HUMAN OTC DRUG Hydra Intensive Blemish Balm SPF30 PA TITANIUM DIOXIDE OCTINOXATE ZINC OXIDE CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part352 The Doctor's Cosmetic Inc OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.8; 3; .3 mL/60mL; mL/60mL; mL/60mL 43948-8001_946e823a-ff0c-4976-9a94-0b0675f49543 43948-8001 HUMAN OTC DRUG Medi UV Block Suncream SPF50 PA OCTINOXATE OCTOCRYLENE CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part352 The Doctor's Cosmetic Inc OCTINOXATE; OCTOCRYLENE 3; .6 mL/60mL; mL/60mL 43965-0001_80739f65-cc26-40ab-9ec1-d1691cf2620e 43965-0001 HUMAN OTC DRUG Compre Tox Eriodictyon Californicum, Hamamelis Virginiana, Nymphaea Odorata, Plantago Major, Xanthoxylum Fraxineum, Xerophyllum Asphodeloides LIQUID ORAL 20120928 UNAPPROVED HOMEOPATHIC Kevin Sullivan Navillus ERIODICTYON CALIFORNICUM LEAF; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; NYMPHAEA ODORATA ROOT; PLANTAGO MAJOR; XEROPHYLLUM ASPHODELOIDES; YUCCA FILAMENTOSA; ZANTHOXYLUM AMERICANUM BARK 3; 3; 3; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 43975-220_c94d8749-b1fc-4b8d-b2aa-4d063f573254 43975-220 HUMAN PRESCRIPTION DRUG Carbidopa Carbidopa TABLET ORAL 20131101 ANDA ANDA203261 Amerigen Pharmaceuticals Inc. CARBIDOPA 25 mg/1 43979-400_48d9793a-aed9-47b0-a246-e767b201bc7f 43979-400 HUMAN OTC DRUG Golf Pain Away GPA Tea Tree OIl and Eucalyptus Oil OIL TOPICAL 20120601 UNAPPROVED DRUG OTHER Elmore Oil Company Pty Ltd EUCALYPTUS OIL; TEA TREE OIL 38.6; 42.5 mg/mL; mg/mL 43979-439_20ccb5e0-2227-408e-b1ad-6e62ba1dc3de 43979-439 HUMAN OTC DRUG Elmore Oil Tea Tree OIl and Eucalyptus Oil OIL TOPICAL 20130701 UNAPPROVED DRUG OTHER Elmore Oil Company Pty Ltd EUCALYPTUS OIL; TEA TREE OIL 38.6; 42.5 mg/mL; mg/mL 43979-445_3b04cd1f-ed03-47df-9315-1a085ec373c1 43979-445 HUMAN OTC DRUG Outback 2-in-1 Insect Repellent and Protective Sunscreen Octinoxate,4-Methylbenzylidene Camphor and Zinc CREAM TOPICAL 20120701 UNAPPROVED DRUG OTHER Elmore Oil Company Pty Ltd ENZACAMENE; OCTINOXATE; ZINC OXIDE 13; 90; 80 mg/mL; mg/mL; mg/mL 43979-446_28745142-046e-4552-bd9b-1653fbb1a647 43979-446 HUMAN OTC DRUG Outback Series 2-in-1 Sunscreen Octyl Methoxycinnamate,Avobenzone and Zinc Oxide CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Elmore Oil Company Pty Ltd AVOBENZONE; OCTINOXATE; ZINC OXIDE 13; 75; 80 mg/mL; mg/mL; mg/mL 43979-550_5109c9ab-837e-4705-ac81-83a552023a11 43979-550 HUMAN OTC DRUG Out Back Pain Relief Tea Tree OIl and Eucalyptus Oil OIL TOPICAL 20121001 UNAPPROVED DRUG OTHER Elmore Oil Company Pty Ltd EUCALYPTUS OIL; TEA TREE OIL 38.6; 42.5 mg/mL; mg/mL 44001-321_a27562fb-cb3c-4eae-8fb1-f0f823696e31 44001-321 HUMAN PRESCRIPTION DRUG FACTIVE gemifloxacin mesylate TABLET ORAL 20030404 NDA NDA021158 Merus Labs International Inc. GEMIFLOXACIN MESYLATE 320 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 44004-321_178042cd-894a-4368-a36b-1484bb1c012d 44004-321 HUMAN PRESCRIPTION DRUG FACTIVE gemifloxacin mesylate TABLET ORAL 20030404 NDA NDA021158 Vansen Pharma Inc. GEMIFLOXACIN MESYLATE 320 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 44004-801_f99cc35f-6ffa-4f2e-bcdf-e51bb9a17c0d 44004-801 HUMAN PRESCRIPTION DRUG Spectracef cefditoren pivoxil TABLET, FILM COATED ORAL 20130205 NDA NDA021222 Vansen Pharma Inc. CEFDITOREN PIVOXIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44004-802_f99cc35f-6ffa-4f2e-bcdf-e51bb9a17c0d 44004-802 HUMAN PRESCRIPTION DRUG Spectracef Cefditoren Pivoxil TABLET, FILM COATED ORAL 20130205 NDA NDA021222 Vansen Pharma Inc. CEFDITOREN PIVOXIL 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44009-801_edeaf75d-92f5-4fef-a127-ad200561aa71 44009-801 HUMAN PRESCRIPTION DRUG Cefditoren Pivoxil cefditoren pivoxil TABLET, FILM COATED ORAL 20130212 NDA NDA021222 Pharma RomLev Inc. CEFDITOREN PIVOXIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44009-802_edeaf75d-92f5-4fef-a127-ad200561aa71 44009-802 HUMAN PRESCRIPTION DRUG Cefditoren Pivoxil cefditoren pivoxil TABLET, FILM COATED ORAL 20100101 NDA NDA021222 Pharma RomLev Inc. CEFDITOREN PIVOXIL 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44014-085_3656d7ee-bd4c-422c-8e4b-f24517dddc57 44014-085 HUMAN OTC DRUG Icy Hot Medicated Roll, Medium Menthol PATCH TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part348 Nichiban Company Limited MENTHOL 787.5 mg/1 44014-086_3656d7ee-bd4c-422c-8e4b-f24517dddc57 44014-086 HUMAN OTC DRUG Icy Hot Medicated Roll, Large Menthol PATCH TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part348 Nichiban Company Limited MENTHOL 866.25 mg/1 44019-000_19c11e83-696d-4240-9513-1c0439b8827d 44019-000 HUMAN OTC DRUG Antibacterial Moisturizing Hand Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part333E Shanghai Yinjing Medical Supplies Co., Ltd. BENZALKONIUM CHLORIDE .13 g/100g 44019-001_506f9071-a7fd-4e02-bb66-3c2b3c6051cb 44019-001 HUMAN OTC DRUG MEDICATED-PADS Hemorrhoidal Pads with Witch Hazel WITCH HAZEL LIQUID TOPICAL 20130710 OTC MONOGRAPH FINAL part346 Shanghai Yinjing Medical Supplies Co., Ltd. WITCH HAZEL 50 g/100g 44019-002_e07aedae-7a00-4753-91bc-2244dff6a55c 44019-002 HUMAN OTC DRUG Flushable Medicated Wipes Hemorrhoidal Pads with Witch Hazel and Aloe WITCH HAZEL LIQUID TOPICAL 20130708 OTC MONOGRAPH FINAL part346 Shanghai Yinjing Medical Supplies Co., Ltd. WITCH HAZEL 50 g/100g 44019-003_6dc591f3-eaff-4244-8440-e2c5888b45b6 44019-003 HUMAN OTC DRUG Antimicrobial Alcohol Hand wipes ALCOHOL LIQUID TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part333E Shanghai Yinjing Medical Supplies Co., Ltd. ALCOHOL 65.9 g/100g 44019-004_c559ef22-6e73-4359-a0eb-2db7f29bafb1 44019-004 HUMAN OTC DRUG Skin Protectant Flushable Wipes DIMETHICONE LIQUID TOPICAL 20130926 OTC MONOGRAPH FINAL part347 Shanghai Yinjing Medical Supplies Co., Ltd. DIMETHICONE 3.2 g/100g 44019-111_0b0d9007-44cb-4680-9bd9-45cfaa79d6fb 44019-111 HUMAN OTC DRUG ALCOHOL PREP PAD - MEDIUM ISOPROPYL ALCOHOL SWAB TOPICAL 20130414 OTC MONOGRAPH NOT FINAL part333A Shanghai Yinjing Medical Supplies Co., Ltd. ISOPROPYL ALCOHOL 70 g/100g 44019-112_0ae6b36f-73d3-4591-8b15-e5189ee10382 44019-112 HUMAN OTC DRUG ALCOHOL PREP PAD - LARGE ISOPROPYL ALCOHOL SWAB TOPICAL 20130414 OTC MONOGRAPH NOT FINAL part333A Shanghai Yinjing Medical Supplies Co., Ltd. ISOPROPYL ALCOHOL 70 g/100g 44019-211_45071d0d-b120-4486-84a5-074931f87a88 44019-211 HUMAN OTC DRUG POVIDONE-IODINE PREP PAD POVIDONE-IODINE SWAB TOPICAL 20130414 OTC MONOGRAPH NOT FINAL part333A Shanghai Yinjing Medical Supplies Co., Ltd. POVIDONE-IODINE 10 g/100g 44019-236_245afb08-3b7a-4712-9382-949aacb568b3 44019-236 HUMAN OTC DRUG POVIDONE-IODINE SWABSTICK POVIDONE-IODINE SWAB TOPICAL 20130414 OTC MONOGRAPH NOT FINAL part333A Shanghai Yinjing Medical Supplies Co., Ltd. POVIDONE-IODINE 10 g/100g 44019-323_92adb834-0b62-4566-a5d3-f31794ef941c 44019-323 HUMAN OTC DRUG BZK ANTISEPTIC TOWELETTE BENZALKONIUM CHLORIDE SWAB TOPICAL 20130414 OTC MONOGRAPH NOT FINAL part333A Shanghai Yinjing Medical Supplies Co., Ltd. BENZALKONIUM CHLORIDE .13 g/100g 44019-400_fab2c3a6-fb56-425d-b742-48532b594421 44019-400 HUMAN OTC DRUG Baby Wipes with Allantoin ALLANTOIN LIQUID TOPICAL 20140703 OTC MONOGRAPH FINAL part347 Shanghai Yinjing Medical Supplies Co., Ltd. ALLANTOIN .5 g/100g 44019-401_c1729cad-64fb-4bbc-a87b-d0e400067e2b 44019-401 HUMAN OTC DRUG Healthcare Antiseptic Towelette CHLOROXYLENOL LIQUID TOPICAL 20140716 OTC MONOGRAPH NOT FINAL part333E Shanghai Yinjing Medical Supplies Co., Ltd. CHLOROXYLENOL .5 g/100g 44076-006_0ac204bb-b882-4e72-a5d0-9d72c10ad470 44076-006 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20070401 NDA NDA205839 American Welding & Gas NITROGEN 990 mL/L 44076-010_fecbf19f-539f-4fee-87d6-bc9cad920ef6 44076-010 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19870401 NDA NDA205840 American Welding & Gas OXYGEN 990 mL/L 44076-012_2b3a2d59-fd5f-409f-8864-8cf8d0d76a5b 44076-012 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20140501 NDA NDA205704 American Welding & Gas NITROUS OXIDE 990 mL/L 44087-0004_734f50bc-04f3-4363-b26c-992e1d57da50 44087-0004 HUMAN PRESCRIPTION DRUG Serostim somatropin KIT SUBCUTANEOUS 19970725 NDA NDA020604 EMD Serono, Inc. 44087-0005_734f50bc-04f3-4363-b26c-992e1d57da50 44087-0005 HUMAN PRESCRIPTION DRUG Serostim somatropin KIT SUBCUTANEOUS 19960823 NDA NDA020604 EMD Serono, Inc. 44087-0006_734f50bc-04f3-4363-b26c-992e1d57da50 44087-0006 HUMAN PRESCRIPTION DRUG Serostim somatropin KIT SUBCUTANEOUS 19960823 NDA NDA020604 EMD Serono, Inc. 44087-0022_acc85857-44d4-4e36-b084-00fb210753cb 44087-0022 HUMAN PRESCRIPTION DRUG REBIF INTERFERON BETA-1A INJECTION, SOLUTION SUBCUTANEOUS 20020307 BLA BLA103780 EMD Serono, Inc. INTERFERON BETA-1A 22 ug/.5mL Interferon-beta [Chemical/Ingredient],Recombinant Human Interferon beta [EPC],Recombinant Proteins [Chemical/Ingredient] 44087-0044_acc85857-44d4-4e36-b084-00fb210753cb 44087-0044 HUMAN PRESCRIPTION DRUG REBIF interferon beta-1a INJECTION, SOLUTION SUBCUTANEOUS 20020307 BLA BLA103780 EMD Serono, Inc. INTERFERON BETA-1A 44 ug/.5mL Interferon-beta [Chemical/Ingredient],Recombinant Human Interferon beta [EPC],Recombinant Proteins [Chemical/Ingredient] 44087-0188_acc85857-44d4-4e36-b084-00fb210753cb 44087-0188 HUMAN PRESCRIPTION DRUG REBIF REBIDOSE INTERFERON BETA-1A KIT SUBCUTANEOUS 20121221 BLA BLA103780 EMD Serono, Inc. 44087-1005_f9f150bd-95f6-47aa-821b-714f850e8ef2 44087-1005 HUMAN PRESCRIPTION DRUG Saizen somatropin KIT INTRAMUSCULAR; SUBCUTANEOUS 19961008 NDA NDA019764 EMD Serono, Inc. 44087-1080_f9f150bd-95f6-47aa-821b-714f850e8ef2 44087-1080 HUMAN PRESCRIPTION DRUG SAIZEN CLICKEASY somatropin KIT INTRAMUSCULAR; SUBCUTANEOUS 20040709 NDA NDA019764 EMD Serono, Inc. 44087-1088_f9f150bd-95f6-47aa-821b-714f850e8ef2 44087-1088 HUMAN PRESCRIPTION DRUG Saizen somatropin KIT INTRAMUSCULAR; SUBCUTANEOUS 20000829 NDA NDA019764 EMD Serono, Inc. 44087-1112_e93e7b13-ccd8-4d8a-896d-4581820283b5 44087-1112 HUMAN PRESCRIPTION DRUG Gonal-f RFF Pen folltropin alfa INJECTION, SOLUTION SUBCUTANEOUS 20040525 NDA NDA021684 EMD Serono, Inc. FOLLITROPIN 450 [iU]/.75mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] 44087-1113_e93e7b13-ccd8-4d8a-896d-4581820283b5 44087-1113 HUMAN PRESCRIPTION DRUG Gonal-f RFF Pen folltropin alfa INJECTION, SOLUTION SUBCUTANEOUS 20040525 NDA NDA021684 EMD Serono, Inc. FOLLITROPIN 300 [iU]/.5mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] 44087-1114_e93e7b13-ccd8-4d8a-896d-4581820283b5 44087-1114 HUMAN PRESCRIPTION DRUG Gonal-f RFF Pen folltropin alfa INJECTION, SOLUTION SUBCUTANEOUS 20040525 NDA NDA021684 EMD Serono, Inc. FOLLITROPIN 900 [iU]/1.5mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] 44087-1115_8fdda368-e1fe-4b90-b3a3-9dd857430061 44087-1115 HUMAN PRESCRIPTION DRUG Gonal-f RFF Redi-ject FOLLITROPIN INJECTION, SOLUTION SUBCUTANEOUS 20131016 NDA NDA021684 EMD Serono, Inc. FOLLITROPIN 300 [iU]/.5mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] 44087-1116_8fdda368-e1fe-4b90-b3a3-9dd857430061 44087-1116 HUMAN PRESCRIPTION DRUG Gonal-f RFF Redi-ject FOLLITROPIN INJECTION, SOLUTION SUBCUTANEOUS 20131016 NDA NDA021684 EMD Serono, Inc. FOLLITROPIN 450 [iU]/.75mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] 44087-1117_8fdda368-e1fe-4b90-b3a3-9dd857430061 44087-1117 HUMAN PRESCRIPTION DRUG Gonal-f RFF Redi-ject FOLLITROPIN INJECTION, SOLUTION SUBCUTANEOUS 20131016 NDA NDA021684 EMD Serono, Inc. FOLLITROPIN 900 [iU]/1.5mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] 44087-1150_c9252713-194c-41c9-b094-4fa8fd3caac8 44087-1150 HUMAN PRESCRIPTION DRUG Ovidrel choriogonadotropin alfa INJECTION, SOLUTION SUBCUTANEOUS 20031006 NDA NDA021149 EMD Serono, Inc. CHORIOGONADOTROPIN ALFA 250 ug/.5mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] 44087-1225_974e4852-2e24-4e88-8976-c9ba58abcb38 44087-1225 HUMAN PRESCRIPTION DRUG Cetrotide cetrorelix acetate KIT SUBCUTANEOUS 20000811 NDA NDA021197 EMD Serono, Inc. 44087-2011_9952905b-10a4-45d6-8eec-c4104aca002f 44087-2011 HUMAN PRESCRIPTION DRUG Egrifta tesamorelin KIT SUBCUTANEOUS 20120905 NDA NDA022505 EMD Serono, Inc. 44087-3322_acc85857-44d4-4e36-b084-00fb210753cb 44087-3322 HUMAN PRESCRIPTION DRUG REBIF REBIDOSE INTERFERON BETA-1A INJECTION, SOLUTION SUBCUTANEOUS 20121221 BLA BLA103780 EMD Serono, Inc. INTERFERON BETA-1A 22 ug/.5mL Interferon-beta [Chemical/Ingredient],Recombinant Human Interferon beta [EPC],Recombinant Proteins [Chemical/Ingredient] 44087-3344_acc85857-44d4-4e36-b084-00fb210753cb 44087-3344 HUMAN PRESCRIPTION DRUG REBIF REBIDOSE INTERFERON BETA-1A INJECTION, SOLUTION SUBCUTANEOUS 20121221 BLA BLA103780 EMD Serono, Inc. INTERFERON BETA-1A 44 ug/.5mL Interferon-beta [Chemical/Ingredient],Recombinant Human Interferon beta [EPC],Recombinant Proteins [Chemical/Ingredient] 44087-3388_577cc416-04d7-45b1-b645-e382d16ad1dd 44087-3388 HUMAN PRESCRIPTION DRUG Zorbtive somatropin (rDNA origin) KIT SUBCUTANEOUS 20031201 NDA NDA021597 EMD Serono, Inc. 44087-8090_bb6d1744-e134-44d9-ab6b-f7aa5a2bc25b 44087-8090 HUMAN PRESCRIPTION DRUG Serophene clomiPHENE citrate TABLET ORAL 19820322 NDA NDA018361 EMD Serono, Inc. CLOMIPHENE CITRATE 50 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 44087-8822_acc85857-44d4-4e36-b084-00fb210753cb 44087-8822 HUMAN PRESCRIPTION DRUG Rebif interferon beta-1a KIT SUBCUTANEOUS 20041217 BLA BLA103780 EMD Serono, Inc. 44087-9005_438e6eec-7cf2-445a-8b2d-065041523d43 44087-9005 HUMAN PRESCRIPTION DRUG GONAL-F RFF follitropin alfa KIT SUBCUTANEOUS 20040325 NDA NDA021765 EMD Serono, Inc. 44087-9030_79aa68e2-11a6-4556-a4f2-51f2e9a9afd6 44087-9030 HUMAN PRESCRIPTION DRUG Gonal-f follitropin alfa KIT SUBCUTANEOUS 20040325 NDA NDA020378 EMD Serono, Inc. 44087-9070_79aa68e2-11a6-4556-a4f2-51f2e9a9afd6 44087-9070 HUMAN PRESCRIPTION DRUG Gonal-f follitropin alfa KIT SUBCUTANEOUS 20040325 NDA NDA020378 EMD Serono, Inc. 44099-001_5697b8cf-7d03-4f97-b7f6-b3bd926f20f9 44099-001 HUMAN OTC DRUG skin MD Natural octinoxate, octisalate, homosalate LOTION TOPICAL 20080819 OTC MONOGRAPH NOT FINAL part352 21st Century Formulations HOMOSALATE; OCTINOXATE; OCTISALATE 3; 7; 5 mg/100mL; mg/100mL; mg/100mL 44117-0001_f7c97c4f-7542-445a-96b4-5d2d8617b5c0 44117-0001 HUMAN OTC DRUG Testosterone Testosterone TABLET ORAL 20130403 UNAPPROVED HOMEOPATHIC Zoe Processing TESTOSTERONE 30 [hp_X]/mg 44117-0002_e121aea2-a01c-465b-b048-8df536fa7953 44117-0002 HUMAN OTC DRUG Testosterone Testosterone, TABLET ORAL 20140429 UNAPPROVED HOMEOPATHIC Zoe Processing TESTOSTERONE 30 [hp_X]/1 44118-750_7491c2fa-932e-473e-bd34-e14dc712100d 44118-750 HUMAN PRESCRIPTION DRUG Duet DHA Balanced .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, IRON, MAGNESIUM, ZINC OXIDE, SODIUM SELENATE, CUPRIC OXIDE, IODINE, CHOLINE, OMEGA-3 FATTY ACIDS KIT 20121030 UNAPPROVED DRUG OTHER Eckson Labs, LLC 44118-800_e46eabf4-2f2a-4241-b0ac-9fbb315afe88 44118-800 HUMAN PRESCRIPTION DRUG Duet DHA Balanced .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, IRON, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, IODINE, OMEGA-3 FATTY ACIDS KIT ORAL 20121030 UNAPPROVED DRUG OTHER Eckson Labs, LLC 44118-807_ab0eed0e-59b1-408c-84ae-f6cc7bc2a77d 44118-807 HUMAN PRESCRIPTION DRUG Duet DHA 400 .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, IRON, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, IODINE, OMEGA-3 FATTY ACIDS KIT ORAL 20110909 UNAPPROVED DRUG OTHER Eckson Labs, LLC 44118-809_577e9f87-234c-4752-a6f7-b8f4cdbe820a 44118-809 HUMAN PRESCRIPTION DRUG Duet DHA 400 ec .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide, iodine, omega-3 fatty acids KIT ORAL 20110909 UNAPPROVED DRUG OTHER Eckson Labs, LLC 44118-902_49b05464-a4a1-492a-b9a9-87d71f461e1e 44118-902 HUMAN PRESCRIPTION DRUG NataChew .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, IRON, NIACINAMIDE TABLET, CHEWABLE ORAL 20121015 UNAPPROVED DRUG OTHER Eckson Labs, LLC .ALPHA.-TOCOPHEROL ACETATE, D-; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; IRON; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE 20; 2700; 120; 400; 12; 1; 28; 20; 10; 3; 2 [iU]/1; [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 44119-001_2ec0c19c-c716-42df-b811-81d0721dfff0 44119-001 HUMAN OTC DRUG Disney Princess Antibacterial Hand Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part333E Peachtree Playthings, Inc. BENZALKONIUM CHLORIDE 1 mg/mL 44119-002_7707f7cf-f89b-43fe-809d-17baf144223f 44119-002 HUMAN OTC DRUG Disney Antibacterial Hand Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part333E Peachtree Playthings, Inc. BENZALKONIUM CHLORIDE 1 mg/mL 44119-003_ed29b65c-d6b1-4dc5-bd87-10fe13e42768 44119-003 HUMAN OTC DRUG Disney PIXAR Cars Antibacterial Hand Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part333E Peachtree Playthings, Inc. BENZALKONIUM CHLORIDE 1 mg/mL 44119-004_5d732c82-480c-4d8d-8112-a81ce82b689e 44119-004 HUMAN OTC DRUG Disney PIXAR MONSTERS UNIVERSITY Antibacterial Hand Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130516 OTC MONOGRAPH NOT FINAL part333E Peachtree Playthings, Inc. BENZALKONIUM CHLORIDE 1 mg/mL 44119-005_a81e297f-17a9-48df-88a2-3ef3d43c9b83 44119-005 HUMAN OTC DRUG Disney DOC McStuffins Antibacterial Hand Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130516 OTC MONOGRAPH NOT FINAL part333E Peachtree Playthings, Inc. BENZALKONIUM CHLORIDE 1 mg/mL 44119-006_20b3f1e1-d77e-4ede-a261-12d71e0f249f 44119-006 HUMAN OTC DRUG Disney FROZEN Antibacterial Hand Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140326 OTC MONOGRAPH NOT FINAL part333E Peachtree Playthings, Inc. BENZALKONIUM CHLORIDE .1 g/100g 44183-180_19da355f-fff4-42a4-8366-a83ddb82fa01 44183-180 HUMAN PRESCRIPTION DRUG Ceftibuten CEFTIBUTEN DIHYDRATE SUSPENSION ORAL 20131001 NDA AUTHORIZED GENERIC NDA050686 Macoven Pharmaceuticals CEFTIBUTEN DIHYDRATE 180 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44183-201_f0ca6eee-6c7a-4a3f-8c4d-c4455b96a6ff 44183-201 HUMAN OTC DRUG TRIP-PSE TRIPROLIDINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20100208 OTC MONOGRAPH FINAL part341 Macoven Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 10; .938 mg/mL; mg/mL 44183-203_49847b8a-b3f5-4576-9030-337b46877bc9 44183-203 HUMAN OTC DRUG BP8 Cough PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN, and DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20110324 OTC MONOGRAPH FINAL part341 Macoven Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 15; 175; 30 mg/5mL; mg/5mL; mg/5mL 44183-208_1cbacf04-8d38-4f96-bfcd-70656610a2a5 44183-208 HUMAN OTC DRUG Pyril D PHENYLEPHRINE HYDROCHLORIDE and PYRILAMINE MALEATE SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part341 Macoven Pharmaceuticals PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE 5; 16 mg/5mL; mg/5mL 44183-210_4195d21b-c5e1-46e0-a9b1-e2a048b3afd4 44183-210 HUMAN OTC DRUG Pyril DM PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE, and DEXTROMETHORPHAN HYDROBROMIDE SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part341 Macoven Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE 15; 5; 16 mg/5mL; mg/5mL; mg/5mL 44183-220_e6ccd6e8-7156-41b4-9dd1-a101cf78260c 44183-220 HUMAN OTC DRUG Brom/PSE/DM Cough BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20120105 OTC MONOGRAPH FINAL part341 Macoven Pharmaceuticals BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 10; 30 mg/5mL; mg/5mL; mg/5mL 44183-311_0ac0a080-4104-4625-b34f-77c39aa96275 44183-311 HUMAN OTC DRUG Brompheniramine Pseudoephedrine DM BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20110301 OTC MONOGRAPH FINAL part341 Macoven Pharmaceuticals BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 20; 20 mg/5mL; mg/5mL; mg/5mL 44183-313_7a237acf-d795-49b6-a208-b6ee84e80e8f 44183-313 HUMAN OTC DRUG Brompheniramine Phenylephrine DM BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20110301 OTC MONOGRAPH FINAL part341 Macoven Pharmaceuticals BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 20; 10 mg/5mL; mg/5mL; mg/5mL 44183-400_19da355f-fff4-42a4-8366-a83ddb82fa01 44183-400 HUMAN PRESCRIPTION DRUG Ceftibuten ceftibuten dihydrate CAPSULE ORAL 20131001 NDA AUTHORIZED GENERIC NDA050685 Macoven Pharmaceuticals CEFTIBUTEN DIHYDRATE 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44183-401_3c60265c-966c-4b05-8273-4a6ab5206ec7 44183-401 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride and Clidinium Bromide CHLORDIAZEPOXIDE HYDROCHLORIDE and CLIDINIUM BROMIDE CAPSULE ORAL 20110504 UNAPPROVED DRUG OTHER Macoven Pharmaceuticals CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] 44183-440_f363dae8-feb0-4d47-b02e-be134a6a899b 44183-440 HUMAN PRESCRIPTION DRUG Isometheptene Mucate, Dichloralphenazone, and Acetaminophen ISOMETHEPTENE MUCATE, DICHLORALPHENAZONE, and ACETAMINOPHEN CAPSULE ORAL 20110628 UNAPPROVED DRUG OTHER Macoven Pharmaceuticals ACETAMINOPHEN; DICHLORALPHENAZONE; ISOMETHEPTENE MUCATE 325; 100; 65 mg/1; mg/1; mg/1 CIV 44183-442_e58fccf9-a65d-457e-aa9e-0769cb55fed6 44183-442 HUMAN PRESCRIPTION DRUG Nodolor Isometheptene Mucate, DICHLORALPHENAZONE, and ACETAMINOPHEN CAPSULE ORAL 20110628 UNAPPROVED DRUG OTHER Macoven Pharmaceuticals ACETAMINOPHEN; DICHLORALPHENAZONE; ISOMETHEPTENE MUCATE 325; 100; 65 mg/1; mg/1; mg/1 CIV 44183-507_8be2600a-22c2-46b4-bbaa-ca437d640afa 44183-507 HUMAN PRESCRIPTION DRUG ZEMA PAK Dexamethasone TABLET ORAL 20060707 ANDA ANDA084610 Macoven Pharmaceuticals LLC DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 44183-508_8be2600a-22c2-46b4-bbaa-ca437d640afa 44183-508 HUMAN PRESCRIPTION DRUG ZEMA PAK Dexamethasone TABLET ORAL 20060707 ANDA ANDA084610 Macoven Pharmaceuticals LLC DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 44183-509_8be2600a-22c2-46b4-bbaa-ca437d640afa 44183-509 HUMAN PRESCRIPTION DRUG ZEMA PAK Dexamethasone TABLET ORAL 20060707 ANDA ANDA084610 Macoven Pharmaceuticals LLC DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 44183-514_606c00b7-49ba-4360-97cd-ef6e58ec379c 44183-514 HUMAN PRESCRIPTION DRUG V-COF brompheniramine maleate, PHENYLEPHRINE HYDROCHLORIDE, and CARBETAPENTANE CITRATE SUSPENSION ORAL 20100204 UNAPPROVED DRUG OTHER Macoven Pharmaceuticals BROMPHENIRAMINE MALEATE; CARBETAPENTANE CITRATE; PHENYLEPHRINE HYDROCHLORIDE 6; 25; 10 mg/5mL; mg/5mL; mg/5mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 44183-550_25c3a7cd-6c65-447f-b6c1-cb59ea91d7c6 44183-550 HUMAN OTC DRUG CARDEC DM PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE, and DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20110318 OTC MONOGRAPH FINAL part341 Macoven Pharmaceuticals CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 3; 3.5 mg/mL; mg/mL; mg/mL 44183-604_ef4e97a7-eb20-4ce8-a5c4-3dde5cd083a8 44183-604 HUMAN OTC DRUG CARDEC PHENYLEPHRINE HYDROCHLORIDE and CHLORPHENIRAMINE MALEATE LIQUID ORAL 20110609 OTC MONOGRAPH FINAL part341 Macoven Pharmaceuticals CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 3.5 mg/mL; mg/mL 44183-880_56b8c106-f13d-4d63-a8fc-8460bc1d77f6 44183-880 HUMAN PRESCRIPTION DRUG Desvenlafaxine Extended-release desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20130710 NDA AUTHORIZED GENERIC NDA204683 Macoven Pharmaceuticals DESVENLAFAXINE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 44183-890_56b8c106-f13d-4d63-a8fc-8460bc1d77f6 44183-890 HUMAN PRESCRIPTION DRUG Desvenlafaxine Extended-release desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20130710 NDA AUTHORIZED GENERIC NDA204683 Macoven Pharmaceuticals DESVENLAFAXINE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 44183-900_6a2d7b3d-7e97-45da-b982-2b38216c55c8 44183-900 HUMAN PRESCRIPTION DRUG Spinosad spinosad SUSPENSION TOPICAL 20120718 NDA NDA022408 Macoven Pharmaceuticals SPINOSAD 9 mg/mL Pediculicide [EPC] 44206-251_2b027b25-7400-4830-bb18-68a43258c9e9 44206-251 PLASMA DERIVATIVE AlbuRx ALBUMIN (HUMAN) SOLUTION INTRAVENOUS 20090106 BLA BLA102366 CSL Behring AG ALBUMIN (HUMAN) 12.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 44206-300_19e0d0b4-4bd4-4bdc-bab1-44bcc88489a2 44206-300 PLASMA DERIVATIVE Rhophylac HUMAN RHO(D) IMMUNE GLOBULIN SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090106 BLA BLA125070 CSL Behring AG HUMAN RHO(D) IMMUNE GLOBULIN 1500 [iU]/2mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 44206-310_f7e7083a-7ceb-44da-a86a-19e16cb5d614 44206-310 PLASMA DERIVATIVE AlbuRx ALBUMIN (HUMAN) SOLUTION INTRAVENOUS 20090106 BLA BLA102366 CSL Behring AG ALBUMIN (HUMAN) 12.5 g/250mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 44206-416_14c69ccf-9b5a-414d-9a01-f06d0bb1d398 44206-416 PLASMA DERIVATIVE Carimune Nanofiltered HUMAN IMMUNOGLOBULIN G INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090210 BLA BLA102367 CSL Behring AG HUMAN IMMUNOGLOBULIN G 3 g/1 Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 44206-417_14c69ccf-9b5a-414d-9a01-f06d0bb1d398 44206-417 PLASMA DERIVATIVE Carimune Nanofiltered HUMAN IMMUNOGLOBULIN G INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090210 BLA BLA102367 CSL Behring AG HUMAN IMMUNOGLOBULIN G 6 g/1 Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 44206-418_14c69ccf-9b5a-414d-9a01-f06d0bb1d398 44206-418 PLASMA DERIVATIVE Carimune Nanofiltered HUMAN IMMUNOGLOBULIN G INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090210 BLA BLA102367 CSL Behring AG HUMAN IMMUNOGLOBULIN G 12 g/1 Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 44206-436_adcba113-adb6-4010-b633-61b6ce83e6a4 44206-436 PLASMA DERIVATIVE Privigen Human Immunoglobulin G LIQUID INTRAVENOUS 20090120 BLA BLA125201 CSL Behring AG HUMAN IMMUNOGLOBULIN G 5 g/50mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 44206-437_adcba113-adb6-4010-b633-61b6ce83e6a4 44206-437 PLASMA DERIVATIVE Privigen Human Immunoglobulin G LIQUID INTRAVENOUS 20090120 BLA BLA125201 CSL Behring AG HUMAN IMMUNOGLOBULIN G 10 g/100mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 44206-438_adcba113-adb6-4010-b633-61b6ce83e6a4 44206-438 PLASMA DERIVATIVE Privigen Human Immunoglobulin G LIQUID INTRAVENOUS 20090120 BLA BLA125201 CSL Behring AG HUMAN IMMUNOGLOBULIN G 20 g/200mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 44206-439_adcba113-adb6-4010-b633-61b6ce83e6a4 44206-439 PLASMA DERIVATIVE Privigen Human Immunoglobulin G LIQUID INTRAVENOUS 20090120 BLA BLA125201 CSL Behring AG HUMAN IMMUNOGLOBULIN G 40 g/200mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 44206-451_82ce04e9-a016-4809-9640-5bb5acdffb91 44206-451 PLASMA DERIVATIVE Hizentra HUMAN IMMUNOGLOBULIN G LIQUID SUBCUTANEOUS 20111003 BLA BLA125350 CSL Behring AG HUMAN IMMUNOGLOBULIN G .2 g/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 44206-452_82ce04e9-a016-4809-9640-5bb5acdffb91 44206-452 PLASMA DERIVATIVE Hizentra HUMAN IMMUNOGLOBULIN G LIQUID SUBCUTANEOUS 20111003 BLA BLA125350 CSL Behring AG HUMAN IMMUNOGLOBULIN G .2 g/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 44206-454_82ce04e9-a016-4809-9640-5bb5acdffb91 44206-454 PLASMA DERIVATIVE Hizentra HUMAN IMMUNOGLOBULIN G LIQUID SUBCUTANEOUS 20111003 BLA BLA125350 CSL Behring AG HUMAN IMMUNOGLOBULIN G .2 g/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 44206-455_82ce04e9-a016-4809-9640-5bb5acdffb91 44206-455 PLASMA DERIVATIVE Hizentra HUMAN IMMUNOGLOBULIN G LIQUID SUBCUTANEOUS 20111003 BLA BLA125350 CSL Behring AG HUMAN IMMUNOGLOBULIN G .2 g/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 44206-532_956999c6-95ee-4889-b149-4ab73f43f931 44206-532 PLASMA DERIVATIVE Cytogam Human Cytomegalovirus Immune Globulin LIQUID INTRAVENOUS 20090106 BLA BLA103189 CSL Behring AG HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN 50 mg/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] 44224-0002_4ad0ed5a-2742-4449-a8f2-f197738107d3 44224-0002 HUMAN OTC DRUG After Bite The Itch Eraser Xtra AMMONIA LIQUID TOPICAL 20141125 OTC MONOGRAPH NOT FINAL part348 Tender Corporation AMMONIA 3.5 g/100g 44224-0005_2aac0ed4-8375-40f1-a6f6-666f54c171f6 44224-0005 HUMAN OTC DRUG After Bite The Itch Eraser KIDS SODIUM BICARBONATE LIQUID TOPICAL 20141126 OTC MONOGRAPH FINAL part347 Tender Corporation SODIUM BICARBONATE 5 g/100g 44224-0006_229f5c35-7a06-41a8-9973-24e33586ccab 44224-0006 HUMAN OTC DRUG AfterBurn LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20110412 OTC MONOGRAPH NOT FINAL part348 Tender Corporation LIDOCAINE HYDROCHLORIDE 2.5 g/100g 44224-0007_d534eb71-ae4a-4e48-a035-a685d6c77f7c 44224-0007 HUMAN OTC DRUG AfterBite with Antihistimine DIPHENHYDRAMINE HYDROCHLORIDE CREAM TOPICAL 20120703 OTC MONOGRAPH NOT FINAL part348 Tender Corporation DIPHENHYDRAMINE HYDROCHLORIDE 2 mL/100mL 44224-0118_57553fbf-e04c-4bb3-8a1e-3cdb7fd52f52 44224-0118 HUMAN OTC DRUG Mountain Series Weekender Medical BENZALKONIUM CHLORIDE, POVIDONE-IODINE, ACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE KIT 20110801 OTC MONOGRAPH FINAL part333A Tender Corporation dba Adventure Medical Kits 44224-0299_63969fb7-907b-4788-8e6d-9c9c21e2c18f 44224-0299 HUMAN OTC DRUG Easy Care First Aid BENZALKONIUM CHLORIDE, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B KIT 20110407 OTC MONOGRAPH FINAL part348 Tender Corp dba Adventure Medical Kits 44224-0699_c7ffd563-e629-424b-af33-1730ea9bafc5 44224-0699 HUMAN OTC DRUG Easy Care First Aid Kit - Outdoor and Travel BENZALKONIUM CHLORIDE, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, IBUPROFEN, ACETAMINOPHEN KIT 20110413 OTC MONOGRAPH FINAL part348 Tender Corp dba Adventure Medical Kits 44224-0999_434e6dde-b242-4b12-b9ee-a8477063bf60 44224-0999 HUMAN OTC DRUG Easy Care First Aid Kit - Sports and Travel BENZALKONIUM CHLORIDE, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, IBUPROFEN, ACETAMINOPHEN KIT 20110413 OTC MONOGRAPH FINAL part348 Tender Corp dba Adventure Medical Kits 44224-1000_42d68a3b-5d81-41cc-8de8-f14402850ff7 44224-1000 HUMAN OTC DRUG ADVENTURE MEDICAL KITS 1 PERSON FIRST AID BENZALKONIUM CHLORIDE, BENZOCAINE, SD ALCOHOL KIT 20100825 OTC MONOGRAPH FINAL part348 Tender Corp dba Adventure Medical Kits 44224-1030_dfba8afa-ce28-4d8b-8744-207ba6d3a162 44224-1030 HUMAN OTC DRUG After Bite The Itch Eraser SODIUM BICARBONATE LIQUID TOPICAL 20140902 OTC MONOGRAPH FINAL part347 Tender Corporation SODIUM BICARBONATE 50 mg/mL 44224-1499_58b9bec3-55b9-4d73-b4aa-97ca425d9f52 44224-1499 HUMAN OTC DRUG Easy Care First Aid Chest - Home and Workshop BENZALKONIUM CHLORIDE, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B KIT 20110413 OTC MONOGRAPH FINAL part348 Tender Corp dba Adventure Medical Kits 44224-1999_2f632b22-3649-433d-b2fa-748e01085413 44224-1999 HUMAN OTC DRUG Easy Care First Aid - All Purpose BENZALKONIUM CHLORIDE, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, IBUPROFEN, ACETAMINOPHEN KIT 20110415 OTC MONOGRAPH FINAL part348 Tender Corp dba Adventure Medical Kits 44224-2000_22f141f4-f307-4e18-a8ca-275e075f2547 44224-2000 HUMAN OTC DRUG ADVENTURE MEDICAL KITS 1-2 PERSON FIRST AID BENZALKONIUM CHLORIDE, ASPIRIN, IBUPROFEN, ISOPROPYL ALCOHOL, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN, DIPHENHYDRAMINE CHLORIDE KIT TOPICAL 20100826 OTC MONOGRAPH NOT FINAL part333B Tender Corp dba Adventure Medical Kits 44224-2500_c6534a3b-0e77-4a7c-8c8c-1068cfa3f130 44224-2500 HUMAN OTC DRUG ADVENTURE MEDICAL KITS 1-2 PERSON NATIONAL SKI PATROL FIRST AID BENZALKONIUM CHLORIDE, ASPIRIN, IBUPROFEN, ISOPROPYL ALCOHOL, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN KIT 20100826 OTC MONOGRAPH NOT FINAL part333B Tender Corp dba Adventure Medical Kits 44224-3000_b2a273a1-92fa-474f-afc9-1620960ee4e1 44224-3000 HUMAN OTC DRUG ADVENTURE MEDICAL KITS 1-4 PERSON FIRST AID BENZALKONIUM CHLORIDE, ASPIRIN, IBUPROFEN, ISOPROPYL ALCOHOL, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN, DIPHENHYDRAMINE CHLORIDE KIT TOPICAL 20100826 OTC MONOGRAPH NOT FINAL part333B Tender Corp dba Adventure Medical Kits 44237-001_fb9d0cfc-5f50-4856-ab66-7a2e6b804b57 44237-001 HUMAN OTC DRUG Linkus Lozenges Cough Suppressant/Oral Anesthetic Menthol LOZENGE ORAL 20100401 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 5 mg/1 44237-002_1ea9092b-5431-4031-9e9d-8dbd26215658 44237-002 HUMAN OTC DRUG Linkus Lozenges Cough Suppressant/Oral Anesthetic Menthol LOZENGE ORAL 20100401 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 5 mg/1 44237-003_c3e67adb-01bc-4baf-bdc2-a09df45a6db8 44237-003 HUMAN OTC DRUG Linkus Lozenges Cough Suppressant/Oral Anesthetic Menthol LOZENGE ORAL 20100401 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 5 mg/1 44237-004_86d55ddc-81be-4418-a0b0-bc7c6286aaa7 44237-004 HUMAN OTC DRUG Linkus Lozenges Cough Suppressant/Oral Anesthetic Menthol LOZENGE ORAL 20100401 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 5 mg/1 44237-005_38f54bc1-34c0-4503-b77c-f403c78fc401 44237-005 HUMAN OTC DRUG Linkus Lozenges Cough Suppressant/Oral Anesthetic Menthol LOZENGE ORAL 20100401 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 5 mg/1 44237-006_47e38c86-dbbe-4aa1-bf0d-403f4ece2c49 44237-006 HUMAN OTC DRUG Linkus Lozenges Cough Suppressant/Oral Anesthetic Menthol LOZENGE ORAL 20100401 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 5 mg/1 44237-007_f6aa67eb-5aa4-4ea8-806b-f47da3e4d5f9 44237-007 HUMAN OTC DRUG Sinosil Nasal Decongestant Xylometazoline HCL SPRAY NASAL 20110209 OTC MONOGRAPH FINAL part341 Herbion Pakistan Pvt Ltd XYLOMETAZOLINE HYDROCHLORIDE .015 mL/15mL 44237-008_80f2c4e7-f566-428e-89e0-5947102d3d25 44237-008 HUMAN OTC DRUG Herbion Naturals Honey-Lemon Cough Drops Menthol LOZENGE ORAL 20130101 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 1.6 mg/1 44237-009_80f3dfc4-e4a9-44a1-a2de-074469b953d6 44237-009 HUMAN OTC DRUG Herbion Naturals Mint Cough Drops Menthol LOZENGE ORAL 20130101 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 6 mg/1 44237-010_da398452-612f-499c-917f-ef984fce1c08 44237-010 HUMAN OTC DRUG Herbion Naturals Orange Cough Drops Menthol LOZENGE ORAL 20130101 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 5 mg/1 44237-013_5165c550-1a06-4932-a136-66a5ecd0dc9d 44237-013 HUMAN OTC DRUG Herbion Naturals Mint Cough Drops Menthol LOZENGE ORAL 20131024 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/1 44237-014_8cc88c49-1039-47a8-af18-655544810f49 44237-014 HUMAN OTC DRUG Herbion Naturals Mint Cough Drops Menthol LOZENGE ORAL 20140423 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/2.51 44237-014_8d70bbbf-7de1-4c34-be3f-0399f7d280af 44237-014 HUMAN OTC DRUG Herbion Naturals Mint Cough drops Menthol LOZENGE ORAL 20141219 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt) Ltd MENTHOL 5.5 mg/2.51 44237-015_007751d3-5e0f-41f5-ac89-261accd0e0ac 44237-015 HUMAN OTC DRUG Herbion Naturals Orange Menthol LOZENGE ORAL 20140415 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/1 44237-016_5cc4549d-2be3-4cb2-8886-845ac895f87d 44237-016 HUMAN OTC DRUG Herbion Naturals Honey Lemon Menthol LOZENGE ORAL 20140415 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/1 44237-100_37c61a09-9bee-4b5f-9642-bf6bcb302e28 44237-100 HUMAN OTC DRUG Herbion Naturals Orange Menthol LOZENGE ORAL 20131201 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/1 44237-300_940c54ed-fa54-4903-9498-4d35845b5d24 44237-300 HUMAN OTC DRUG Herbion Naturals Honey Lemon Menthol LOZENGE ORAL 20131024 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/1 44237-400_026dcf86-2358-41e1-8886-fd984c5cd531 44237-400 HUMAN OTC DRUG Claree Hand Sanitizer Gel Antiseptic GEL TOPICAL 20100401 OTC MONOGRAPH FINAL part333 Herbion Pakistan (Pvt.) Ltd. ALCOHOL 37 mL/60mL 44338-001_8b26670f-3e68-43e7-8ee3-2c2fc6fa100b 44338-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F-18 INJECTION, SOLUTION INTRAVENOUS 20111212 ANDA ANDA203709 Wisconsin Medical Cyclotron LLC FLUDEOXYGLUCOSE F-18 500 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 44338-002_647f6497-acd7-455e-9bae-3029b2c20b5b 44338-002 HUMAN PRESCRIPTION DRUG Ammonia N 13 Ammonia N-13 INJECTION, SOLUTION INTRAVENOUS 20141223 ANDA ANDA204356 Wisconsin Medical Cyclotron, LLC AMMONIA N-13 260 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 44356-0001_b464387f-3f6b-4895-80c8-1bded4cbefd3 44356-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090926 UNAPPROVED MEDICAL GAS Linco Medical & Supply Inc OXYGEN 99 L/100L 44363-1815_2b82f182-ba3a-49bd-8259-25a22ac55b8e 44363-1815 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19880101 NDA NDA205767 Institutional Care Pharmacy OXYGEN 99 L/100L 44376-100_8aa526a7-07a2-4633-87ad-00e3c6471d25 44376-100 HUMAN OTC DRUG Today Vaginal Contraceptive Nonoxynol-9 SPONGE VAGINAL 19830401 NDA NDA018683 Mayer Laboratories, Inc. NONOXYNOL-9 1000 mg/1 44397-001_dcd523d1-de78-4dd7-91b7-8a6d8fcb8732 44397-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19740101 UNAPPROVED MEDICAL GAS Argyle Welding Supply Co. Inc. OXYGEN 99 L/100L 44397-010_f3211ed5-af40-4037-85bb-a3ddceed4257 44397-010 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19740101 UNAPPROVED MEDICAL GAS Argyle Welding Supply Co. Inc. NITROUS OXIDE 99 L/100L 44397-020_2ad3a940-2916-494c-8e9f-187916626074 44397-020 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19740101 UNAPPROVED MEDICAL GAS Argyle Welding Supply Co. Inc. NITROGEN 99 L/100L 44517-001_3763c793-09c0-4f39-8f70-890981b2daff 44517-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20081201 UNAPPROVED MEDICAL GAS Blue Water Industrial Products, Inc. OXYGEN 99 L/100L 44517-010_4ca19378-5b66-4db1-bfb6-fd7561d8e4ac 44517-010 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20081201 UNAPPROVED MEDICAL GAS Blue Water Industrial Products, Inc. NITROGEN 99 L/100L 44517-020_de5bc3ba-a13e-461f-b6d0-e864da16b6bd 44517-020 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 20081201 UNAPPROVED MEDICAL GAS Blue Water Industrial Products, Inc. NITROUS OXIDE 99 L/100L 44523-338_f35c058a-ab44-4d75-96ee-971e2e8a441b 44523-338 HUMAN OTC DRUG BP Wash BENZOYL PEROXIDE EMULSION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333D BioComp Pharma, Inc. BENZOYL PEROXIDE 52.5 mg/g 44523-356_70108abb-6b75-4629-93f3-6971bb0ad7bd 44523-356 HUMAN OTC DRUG BP Cleansing BENZOYL PEROXIDE LOTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333D BioComp Pharma, Inc. BENZOYL PEROXIDE 40 mg/g 44523-372_733ec9a9-8f2c-4e1b-b686-052dc0bc4414 44523-372 HUMAN OTC DRUG BP Cleanser BENZOYL PEROXIDE EMULSION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333D BioComp Pharma, Inc. BENZOYL PEROXIDE 42.5 mg/mL 44523-415_b32fe71a-4a58-04a1-64d3-bc3cc4a895bf 44523-415 HUMAN PRESCRIPTION DRUG Potassium Citrate potassium citrate TABLET ORAL 20131223 NDA AUTHORIZED GENERIC NDA019071 Biocomp Pharma, Inc. POTASSIUM CITRATE 15 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 44523-425_88bfdb3a-68d1-42c8-b74e-d1513a33ffa6 44523-425 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET ORAL 20120607 NDA AUTHORIZED GENERIC NDA021618 Biocomp Pharma, Inc. TINIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 44523-450_88bfdb3a-68d1-42c8-b74e-d1513a33ffa6 44523-450 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET ORAL 20120607 NDA AUTHORIZED GENERIC NDA021618 Biocomp Pharma, Inc. TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 44523-510_484a0cec-b965-4133-8ad8-26ff655c2612 44523-510 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide Sodium Sulfacetamide SHAMPOO TOPICAL 20110915 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 44523-520_2c02462c-bfc4-44cd-8fac-44066e66b560 44523-520 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide, Sulfur SULFACETAMIDE SODIUM, SULFUR CREAM TOPICAL 20110915 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 44523-535_66fc8872-1de8-42c7-b4da-f1dca3f18e4d 44523-535 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide, Sulfur SULFACETAMIDE SODIUM, SULFUR CREAM TOPICAL 20110915 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 20 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 44523-542_1a9ae824-fbd8-4dfa-ab20-49027a424bb6 44523-542 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide, Sulfur SULFACETAMIDE SODIUM CREAM TOPICAL 20110915 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 44523-550_ae60388e-0f09-4e2f-bafa-be3853e2a64f 44523-550 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide, Sulfur SULFACETAMIDE SODIUM, SULFUR EMULSION TOPICAL 20110915 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 20 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 44523-560_901fa5b9-f5b2-4e97-910e-76a52157d6e6 44523-560 HUMAN PRESCRIPTION DRUG SULFACETAMIDE SODIUM, SULFUR SULFACETAMIDE SODIUM, SULFUR EMULSION TOPICAL 20110915 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 44523-568_8c3f2b4c-ad55-48dc-8d37-e1854e04d5e6 44523-568 HUMAN PRESCRIPTION DRUG SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM LIQUID TOPICAL 20110915 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 44523-602_9f757ea5-5aff-45cf-8a00-fe26be71bad9 44523-602 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE AND SULFUR SULFACETAMIDE SODIUM, SULFUR LOTION TOPICAL 20110430 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 44523-603_2eaa2860-f4b1-4174-a828-755f9f809c1e 44523-603 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE AND SULFUR SULFACETAMIDE SODIUM, SULFUR CREAM TOPICAL 20110430 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 g/g; g/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 44523-604_2b69a518-cbfe-4f9e-844b-075dc36bc391 44523-604 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE, SULFUR sulfacetamide sodium, sulfur SUSPENSION TOPICAL 20110604 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 44523-606_c3066efe-f0e8-4c1f-b10c-f0513ca1495e 44523-606 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE SODIUM SULFACETAMIDE LIQUID TOPICAL 20130107 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 44523-607_34d57331-00c9-4069-95d5-bccf24cdbdd9 44523-607 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE AND SULFUR SULFACETAMIDE SODIUM, SULFUR LOTION TOPICAL 20110604 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 44523-609_4deb44a0-ada7-48e8-a6d4-c465576100ec 44523-609 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide and Sulfur sodium sulfacetamide, sulfur KIT TOPICAL 20110415 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. 44523-613_527f34d2-b7b5-4ddc-b460-b73158aca384 44523-613 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE SODIUM SULFACETAMIDE LIQUID TOPICAL 20110907 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 44523-616_ae73ab84-b5a6-40d9-b182-39e0eff2e552 44523-616 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide and Sulfur sodium sulfacetamide, sulfur, avobenzone octinoxate, octisalate KIT TOPICAL 20110415 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. 44523-732_878e22cc-9f69-3074-3212-2b36763b2a65 44523-732 HUMAN PRESCRIPTION DRUG BioFerr 90 Dual-Iron TABLET, FILM COATED ORAL 20140701 UNAPPROVED DRUG OTHER Biocomp Pharma, Inc. ASCORBIC ACID; CYANOCOBALAMIN; DOCUSATE SODIUM; FERROUS GLUCONATE; FOLIC ACID; IRON PENTACARBONYL 138; 16.8; 55; 13.2; 1.4; 88.5 mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 44567-100_6c73d951-08c8-4f9a-a24c-163a17e910d8 44567-100 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120510 ANDA ANDA063145 WG Critical Care, LLC AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 44567-101_6c73d951-08c8-4f9a-a24c-163a17e910d8 44567-101 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120510 ANDA ANDA063146 WG Critical Care, LLC AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 44567-102_6c73d951-08c8-4f9a-a24c-163a17e910d8 44567-102 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120510 ANDA ANDA062772 WG Critical Care, LLC AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 44567-103_6c73d951-08c8-4f9a-a24c-163a17e910d8 44567-103 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120510 ANDA ANDA063140 WG Critical Care, LLC AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 44567-104_9a0cb186-6029-4a35-9dd8-aec3459f9683 44567-104 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120510 ANDA ANDA063142 WG Critical Care, LLC AMPICILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 44567-210_b161981f-7a1b-49d2-a6dd-2adcab7dfe31 44567-210 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051130 ANDA ANDA065176 WG Critical Care, LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 44567-211_b161981f-7a1b-49d2-a6dd-2adcab7dfe31 44567-211 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051130 ANDA ANDA065176 WG Critical Care, LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/20mL; g/20mL beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 44567-212_d191ac2c-1704-4b51-98ff-c2d73fb3d293 44567-212 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20051125 ANDA ANDA065188 WG Critical Care, LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 10; 5 g/100mL; g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 44567-221_7c98f489-f734-4599-b657-22706dca1fdd 44567-221 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130118 ANDA ANDA090560 WG Critical Care, LLC NAFCILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 44567-222_7c98f489-f734-4599-b657-22706dca1fdd 44567-222 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130118 ANDA ANDA090560 WG Critical Care, LLC NAFCILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 44567-235_bcc81df2-20e3-4738-bfcf-301da883c1d9 44567-235 HUMAN PRESCRIPTION DRUG Ceftazidime Ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130131 ANDA ANDA062640 WG Critical Care, LLC CEFTAZIDIME 1 g/20mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-236_bcc81df2-20e3-4738-bfcf-301da883c1d9 44567-236 HUMAN PRESCRIPTION DRUG Ceftazidime Ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130131 ANDA ANDA062640 WG Critical Care, LLC CEFTAZIDIME 2 g/20mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-237_22d6534c-4488-48a1-8d78-e2fb908259de 44567-237 HUMAN PRESCRIPTION DRUG Ceftazidime Ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130131 ANDA ANDA062640 WG Critical Care, LLC CEFTAZIDIME 6 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-240_7e5767ca-4a24-4939-ab60-b494d689279d 44567-240 HUMAN PRESCRIPTION DRUG Cefepime Cefepime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20141010 ANDA ANDA065441 WG Critical Care, LLC CEFEPIME HYDROCHLORIDE 1 g/20mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-241_7e5767ca-4a24-4939-ab60-b494d689279d 44567-241 HUMAN PRESCRIPTION DRUG Cefepime Cefepime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20141010 ANDA ANDA065441 WG Critical Care, LLC CEFEPIME HYDROCHLORIDE 2 g/20mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-310_9cee7cb0-270a-4b55-9116-b8beee66c3c9 44567-310 HUMAN PRESCRIPTION DRUG Penicillin G Potassium Penicillin G Potassium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120510 ANDA ANDA065149 WG Critical Care, LLC PENICILLIN G POTASSIUM 1000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 44567-311_9cee7cb0-270a-4b55-9116-b8beee66c3c9 44567-311 HUMAN PRESCRIPTION DRUG Penicillin G Potassium Penicillin G Potassium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120510 ANDA ANDA065149 WG Critical Care, LLC PENICILLIN G POTASSIUM 5000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 44567-312_9cee7cb0-270a-4b55-9116-b8beee66c3c9 44567-312 HUMAN PRESCRIPTION DRUG Penicillin G Potassium Penicillin G Potassium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120510 ANDA ANDA065149 WG Critical Care, LLC PENICILLIN G POTASSIUM 20000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 44567-330_c5910d90-ca2d-4425-bacb-9f54cf64aa00 44567-330 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20131001 ANDA ANDA065467 WG Critical Care, LLC CEFOXITIN SODIUM 1 g/10mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-331_c5910d90-ca2d-4425-bacb-9f54cf64aa00 44567-331 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20131001 ANDA ANDA065467 WG Critical Care, LLC CEFOXITIN SODIUM 2 g/10mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-332_e84b5a05-4d80-48d0-b8f9-a451ae9cb349 44567-332 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20131001 ANDA ANDA065464 WG Critical Care, LLC CEFOXITIN SODIUM 10 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-504_4dbbb7c8-a4b5-484d-a2a4-4d925010fc44 44567-504 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION INTRAVENOUS 20130711 NDA NDA020262 WG Critical Care, LLC PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 44567-505_4dbbb7c8-a4b5-484d-a2a4-4d925010fc44 44567-505 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION INTRAVENOUS 20130711 NDA NDA020262 WG Critical Care, LLC PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 44567-506_4dbbb7c8-a4b5-484d-a2a4-4d925010fc44 44567-506 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION INTRAVENOUS 20130711 NDA NDA020262 WG Critical Care, LLC PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 44567-507_f19cf6d7-a1c8-42ec-844c-c798512139d9 44567-507 HUMAN PRESCRIPTION DRUG Teniposide Teniposide INJECTION, SOLUTION INTRAVENOUS 20130430 NDA NDA020119 WG Critical Care, LLC TENIPOSIDE 10 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 44567-509_0b5c3d25-c148-4d6f-a712-e254fc39ccac 44567-509 HUMAN PRESCRIPTION DRUG CISplatin CISplatin INJECTION, SOLUTION INTRAVENOUS 20120113 NDA NDA018057 WG Critical Care, LLC CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 44567-510_0b5c3d25-c148-4d6f-a712-e254fc39ccac 44567-510 HUMAN PRESCRIPTION DRUG CISplatin CISplatin INJECTION, SOLUTION INTRAVENOUS 20120113 NDA NDA018057 WG Critical Care, LLC CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 44567-700_d471eef2-a004-4bdd-b2fb-bec136e387ad 44567-700 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080724 ANDA ANDA065329 WG Critical Care, LLC CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-701_d471eef2-a004-4bdd-b2fb-bec136e387ad 44567-701 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080724 ANDA ANDA065329 WG Critical Care, LLC CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-702_d471eef2-a004-4bdd-b2fb-bec136e387ad 44567-702 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080724 ANDA ANDA065329 WG Critical Care, LLC CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-703_04d1c498-c7cc-4d1d-9e0e-484892930c0d 44567-703 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080724 ANDA ANDA065328 WG Critical Care, LLC CEFTRIAXONE SODIUM 10 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-706_a0b0b4be-8eee-49ed-958f-12acc501c48d 44567-706 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20131220 ANDA ANDA063214 WG Critical Care, LLC CEFAZOLIN SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-707_a0b0b4be-8eee-49ed-958f-12acc501c48d 44567-707 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20131220 ANDA ANDA063207 WG Critical Care, LLC CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-708_d22c2aaa-81b7-45bf-9f41-6efa5d8d0ddc 44567-708 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140303 ANDA ANDA063209 WG Critical Care, LLC CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-710_4d14b1a4-39d2-4e96-b84d-e193fbc99b16 44567-710 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121004 ANDA ANDA064125 WG Critical Care, LLC CEFUROXIME SODIUM 750 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-711_4d14b1a4-39d2-4e96-b84d-e193fbc99b16 44567-711 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121004 ANDA ANDA064125 WG Critical Care, LLC CEFUROXIME SODIUM 1.5 g/16mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-712_e4a6cecb-b7bd-4e27-9535-4ab73c2ccc00 44567-712 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121004 ANDA ANDA064124 WG Critical Care, LLC CEFUROXIME SODIUM 7.5 g/80mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-720_4d14b1a4-39d2-4e96-b84d-e193fbc99b16 44567-720 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121004 ANDA ANDA064125 WG Critical Care, LLC CEFUROXIME SODIUM 750 mg/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-722_4d14b1a4-39d2-4e96-b84d-e193fbc99b16 44567-722 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121004 ANDA ANDA064125 WG Critical Care, LLC CEFUROXIME SODIUM 1.5 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 44567-801_4c8a4825-4815-4d68-8d95-183512c5180b 44567-801 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN SODIUM,TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091013 ANDA ANDA065523 WG Critical Care, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 44567-802_4c8a4825-4815-4d68-8d95-183512c5180b 44567-802 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN SODIUM,TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091013 ANDA ANDA065523 WG Critical Care, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 44567-803_4c8a4825-4815-4d68-8d95-183512c5180b 44567-803 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN SODIUM,TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091013 ANDA ANDA065523 WG Critical Care, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 44567-804_c7ba8098-7028-4bfd-a312-65382bfd7e24 44567-804 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091020 ANDA ANDA090498 WG Critical Care, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 36; 4.5 g/180mL; g/180mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 44567-882_4c8a4825-4815-4d68-8d95-183512c5180b 44567-882 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN SODIUM,TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091013 ANDA ANDA065523 WG Critical Care, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 44577-001_a67a0143-b42b-46ac-be25-225c64c03f85 44577-001 HUMAN OTC DRUG CLARUS Antifungal TOLNAFTATE CREAM TOPICAL 20120607 OTC MONOGRAPH FINAL part333C Clinical Therapeutic Solutions TOLNAFTATE 1 g/100g 44577-002_f9bfe083-10cb-4d5a-8470-c2a160fc3ff9 44577-002 HUMAN OTC DRUG CLARUS Antifungal TOLNAFTATE SOLUTION TOPICAL 20120607 OTC MONOGRAPH FINAL part333C Clinical Therapeutic Solutions TOLNAFTATE 1 mL/100mL 44577-020_e55c252f-d964-4c27-9bb0-6d2ae257daf1 44577-020 HUMAN OTC DRUG VerruStat Wart Remover SALICYLIC ACID LIQUID TOPICAL 20131016 OTC MONOGRAPH FINAL part358B Clinical Therapeutic Solutions SALICYLIC ACID 170 mg/mL 44577-040_8e7c936e-23f7-4377-bbfa-a9229d4a665f 44577-040 HUMAN OTC DRUG VerruStat Medicated Plantar Pads SALICYLIC ACID PATCH TOPICAL 20131016 OTC MONOGRAPH FINAL part358B Clinical Therapeutic Solutions SALICYLIC ACID .4 g/100g 44577-205_5b5b821e-1568-4187-a1dc-e14a182a21a9 44577-205 HUMAN OTC DRUG MacerRx Web MICONAZOLE NITRATE CREAM TOPICAL 20130606 OTC MONOGRAPH FINAL part333C Clinical Therapeutic Solutions MICONAZOLE NITRATE 2 g/100g 44577-623_70b54937-31c4-4216-ac05-d61967bed3fb 44577-623 HUMAN OTC DRUG KERA HC Hydrocortisone HYDROCORTISONE CREAM TOPICAL 20121017 OTC MONOGRAPH FINAL part348 Clinical Therapeutic Solutions HYDROCORTISONE 1 g/100g 44577-704_c21883b9-b3c8-499e-bac5-4eca2eb8207e 44577-704 HUMAN OTC DRUG LidoStat LIDOCAINE HCL CREAM TOPICAL 20130619 OTC MONOGRAPH NOT FINAL part348 Clinical Therapeutic Solutions LIDOCAINE HYDROCHLORIDE 40 mg/g 44577-711_f7935b7f-24d4-491a-89de-c7de7cc9b101 44577-711 HUMAN OTC DRUG TRI-SOFT SOFTENING BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20121206 OTC MONOGRAPH FINAL part333E Clinical Therapeutic Solutions BENZALKONIUM CHLORIDE 1.3 mg/mL 44597-5358_e0d6456f-1308-4c97-b2c0-228534403621 44597-5358 HUMAN OTC DRUG Herbon Wild Cherry Menthol and Echinacea LOZENGE ORAL 20090930 OTC MONOGRAPH FINAL part341 Purity Life Division of SunOpta ECHINACEA; MENTHOL 100; 2 mg/1; mg/1 44597-5505_a3fd4c19-574d-4aee-bae9-4c9972da6fe9 44597-5505 HUMAN OTC DRUG Herbon Glacial Mint Echinacea Purpurea, Menthol, and Eucalyptus Oil LOZENGE ORAL 20090930 OTC MONOGRAPH FINAL part341 Purity Life Division of SunOpta ECHINACEA PURPUREA; EUCALYPTUS OIL; MENTHOL 7.35; 6; 10 mg/1; mg/1; mg/1 44597-5535_fad6077b-2fc9-4017-b8f8-b9b95ccb5856 44597-5535 HUMAN OTC DRUG Herbon Sugar Free Lemon Honey Menthol and Echinacea Purpurea LOZENGE ORAL 20090930 OTC MONOGRAPH FINAL part341 Purity Life Division of SunOpta Co. ECHINACEA PURPUREA; MENTHOL 7.35; 8 mg/1; mg/1 44597-5605_e1937a4f-018f-44d5-a101-536edf4a5fbc 44597-5605 HUMAN OTC DRUG Herbon Berry Buddies/Watermelon Goodypops Pectin and Echinacea Purpurea LOZENGE ORAL 20090930 OTC MONOGRAPH FINAL part341 Purity Life Division of SunOpta ECHINACEA PURPUREA; PECTIN 50; 10 mg/1; mg/1 44662-3111_f1ad775d-b008-4491-b830-3bc6ed3a3eab 44662-3111 HUMAN OTC DRUG Antimicrobial alcohol LIQUID TOPICAL 20131030 OTC MONOGRAPH NOT FINAL part333E Hopkins Medical ALCOHOL 700 mL/L 44717-148_170665cf-e1c5-4adc-b24e-817311ef787d 44717-148 HUMAN OTC DRUG Age Defying Blemish Treatment Salicylic Acid CREAM TOPICAL 20131024 OTC MONOGRAPH FINAL part358H Wasatch Product Development, LLC SALICYLIC ACID 2 g/100mL 44717-532_05c929d2-f4fd-4b0b-8cb9-0c2f50a8610c 44717-532 HUMAN OTC DRUG Natures Sunshine Products Everflex Topical Analgesic Pain Relief Menthol CREAM TOPICAL 20100813 OTC MONOGRAPH NOT FINAL part348 Wasatch Product Development, LLC MENTHOL 1.25 g/100g 44717-533_46a00fb6-410c-48a8-bc01-f78798790da9 44717-533 HUMAN OTC DRUG Natria Nourishing Daily Defense Ethylhexyl Methoxycinnamate, Zinc Oxide CREAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 Wasatch Product Development OCTINOXATE; ZINC OXIDE 7.5; 2.5 mL/100mL; mL/100mL 44717-534_515fa48a-5ed7-4c9d-aee5-fcc3e2e610f1 44717-534 HUMAN OTC DRUG Balancing Daily Defense SPF 15 Ethylhexyl Methoxycinnamate, Zinc Oxide CREAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 Wasatch Product Development, Inc. OCTINOXATE; ZINC OXIDE 7.5; 3 mL/100mL; mL/100mL 44717-535_5b0cf83e-5231-4d7b-bd21-312348a7d201 44717-535 HUMAN OTC DRUG Natria Acne Treatment Salicylic Acid CREAM TOPICAL 20100628 OTC MONOGRAPH NOT FINAL part333 Wasatch Product Development, Inc. SALICYLIC ACID 30 mL/100mL 44717-536_1ef931a4-35c1-4f41-a2c1-08c5b835a8fe 44717-536 HUMAN OTC DRUG Tahitian Noni Sunscreen Avobenzone, Homosalate, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100628 OTC MONOGRAPH NOT FINAL part352 Wasatch Product Development AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 6.5; 7; 5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 44717-538_9412749c-b788-4b7f-8b54-7503da58fb93 44717-538 HUMAN OTC DRUG Natria Brightening SPF 15 Ethylhexl Methoxycinnamate, Zinc Oxide CREAM TOPICAL 20100719 OTC MONOGRAPH NOT FINAL part352 Wasatch Product Development OCTINOXATE; ZINC OXIDE 7.5; 2.5 mL/100mL; mL/100mL 44717-890_f741bcaf-89e1-4174-9f81-54075b8aa88f 44717-890 HUMAN OTC DRUG Canker Complete Canker Sore Relief Menthol CREAM TOPICAL 20101011 OTC MONOGRAPH FINAL part341 Wasatch Product Development MENTHOL .5 g/100g 44738-4001_146504fc-a0de-446c-911d-660248fd8f01 44738-4001 HUMAN OTC DRUG Ginsamin Memory ginkgo leaf extract CAPSULE ORAL 20100306 UNAPPROVED DRUG OTHER BioGrand Co., Ltd ASIAN GINSENG; GINKGO 75; 100.2 mg/1; mg/1 44738-5001_d6d2fa42-3753-46dc-81a0-d2d370338c82 44738-5001 HUMAN OTC DRUG Ginsamin Health ginsamin health ginkgo leaf extract CAPSULE ORAL 20100307 UNAPPROVED DRUG OTHER Biogrand Co., Ltd ASIAN GINSENG; GINKGO 75; 90 mg/300mg; mg/300mg 44738-6001_a8c08cd0-c00a-4aa2-9225-66b13db3f98c 44738-6001 HUMAN OTC DRUG Ginsamin Beauty ginkgo leaf extract GRANULE ORAL 20100307 UNAPPROVED DRUG OTHER Biogrand Co., Ltd ASIAN GINSENG; GINKGO; HYALURONIC ACID; N-ACETYLGLUCOSAMINE 150; 150; 60; 200 mg/2000mg; mg/2000mg; mg/2000mg; mg/2000mg 44738-7001_2cbb9cc7-24c2-41d0-865d-00779a30809e 44738-7001 HUMAN OTC DRUG Ginsamin Energy ginkgo leaf extract LIQUID ORAL 20100307 UNAPPROVED DRUG OTHER Biogrand Co., Ltd ASCORBIC ACID; ASIAN GINSENG; CREATINE; GINKGO; TAURINE 1000; 200; 10000; 160; 1000 mg/20g; mg/20g; mg/20g; mg/20g; mg/20g 44738-8001_263a6b61-1c3f-4059-9055-3fac0e5306f1 44738-8001 HUMAN OTC DRUG Ginsamin Power ginkgo leaf extract TABLET ORAL 20100307 UNAPPROVED DRUG OTHER Biogrand Co., Ltd 1-OCTACOSANOL; ASIAN GINSENG; GINKGO; ZINC 3; 118.2; 80.4; 5.4 mg/1; mg/1; mg/1; mg/1 44781-110_e18799bc-0be5-4444-9d07-1808ebb134c5 44781-110 HUMAN OTC DRUG ESOPINIO SUN SHIELD PLUS SPF 35 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 ZION SYNTHETIC FIBER CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.55; 1.4 mL/70mL; mL/70mL 44781-120_43654868-5319-4987-8fbd-d568d17eaa0f 44781-120 HUMAN OTC DRUG WRINKLESS PLUS CT-1 LIFTING UP ESSENCE DIMETHICONE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 ZION SYNTHETIC FIBER CO., LTD. DIMETHICONE .45 mL/45mL 44781-130_62088037-9364-47f9-a9ac-dc8f78c245a2 44781-130 HUMAN OTC DRUG BIOWHITE BEAUTY SERUM ALLANTOIN CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 ZION SYNTHETIC FIBER CO., LTD. ALLANTOIN .2 g/40g 44781-140_e2ff4509-12eb-46a9-9a2f-e1b36786e09a 44781-140 HUMAN OTC DRUG ESOPINIO FRESH AND CLEAR FOUNDATION SPF20 TITANIUM DIOXIDE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 ZION SYNTHETIC FIBER CO., LTD. TITANIUM DIOXIDE 3.5 g/35g 44781-150_2ec37f00-c67c-4c69-9cd8-73d326db80e1 44781-150 HUMAN OTC DRUG WRINKLESS CT-1 EYE DIMETHICONE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 ZION SYNTHETIC FIBER CO., LTD. DIMETHICONE .3 g/30g 44781-160_00e63613-bce5-48ec-9e61-99c2b1e7f263 44781-160 HUMAN OTC DRUG BIOWHITE BRIGHTENING ESSENCE DIMETHICONE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 ZION SYNTHETIC FIBER CO., LTD. DIMETHICONE .5 mL/50mL 44781-170_22a29026-beca-4096-a8d1-d814c72312d7 44781-170 HUMAN OTC DRUG ESOPINIO ANIMATING WATER Dimethicone CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 ZION SYNTHETIC FIBER CO., LTD. DIMETHICONE .55 g/55g 44781-180_72a4ebde-71f4-4379-a2bd-9f147ae9dc00 44781-180 HUMAN OTC DRUG REBIRTH HAIR PYRITHIONE ZINC SHAMPOO CUTANEOUS 20100401 OTC MONOGRAPH FINAL part358H ZION SYNTHETIC FIBER CO., LTD. PYRITHIONE ZINC .6 mL/360mL 44781-190_e2761238-41a4-4e30-b274-557539924c20 44781-190 HUMAN OTC DRUG REBIRTH HAIR TONIC WITCH HAZEL SOLUTION CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 ZION SYNTHETIC FIBER CO., LTD. WITCH HAZEL .13 mL/130mL 44781-200_4799401f-7c45-49dd-bba0-4151441a1a3e 44781-200 HUMAN OTC DRUG ESOPINIO JEWEL WITCH HAZEL SOAP CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 ZION SYNTHETIC FIBER CO., LTD. WITCH HAZEL .12 g/120g 44781-210_f7ec0ec5-46bb-45a8-a125-9181ed0e16f4 44781-210 HUMAN OTC DRUG BIOWHITE RESILIENT MASSAGE DIMETHICONE CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part347 ZION SYNTHETIC FIBER CO., LTD. DIMETHICONE 4.27 g/95g 44781-220_e8c2593f-791d-4a03-b7ba-f86f17ef1851 44781-220 HUMAN OTC DRUG RORIS SHINY CC SPF37 PA PLUS PLUS PLUS Titanium Dioxide, Zinc Oxide, Ethylhexyl Methoxycinnamate CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 ZION SYNTHETIC FIBER CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.75; 4.87; 1.5 g/50g; g/50g; g/50g 44781-230_50b5c01b-65de-4ec4-b95a-550585ea2205 44781-230 HUMAN OTC DRUG Esopinio Topaz Phyto Sodium Monofluorophosphate PASTE, DENTIFRICE ORAL 20130601 OTC MONOGRAPH FINAL part355 ZION SYNTHETIC FIBER CO., LTD. SODIUM MONOFLUOROPHOSPHATE .91 g/120g 44781-447_2e7c2d4f-ea08-4398-affe-2548560fa48d 44781-447 HUMAN OTC DRUG Escopinio PHYTO alpha Toothpaste SODIUM MONOFLUOROPHOSPHATE PASTE ORAL 20100121 OTC MONOGRAPH FINAL part355 Zion Synthetic Fiber Corporation Limited SODIUM MONOFLUOROPHOSPHATE .912 g/120g 44827-301_0691d246-5df7-4d84-bd2a-d10bb09db1a0 44827-301 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19940301 UNAPPROVED DRUG OTHER Valesco Pharmaceuticals LLC. EPINEPHRINE HYDROCHLORIDE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 44827-303_3cafda9b-8946-41d8-9687-8fa4c9d4b64a 44827-303 HUMAN PRESCRIPTION DRUG Dehydrated Alcohol Dehydrated alcohol injection SOLUTION INTRASPINAL 19900930 UNAPPROVED DRUG OTHER Valesco Pharmaceuticals ALCOHOL .98 mL/mL 44873-001_d49a401b-8fb9-4681-b214-34b2f528da1a 44873-001 HUMAN OTC DRUG Go Smile AM SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20110505 OTC MONOGRAPH FINAL part355 Go Smile, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 44873-002_2b40622e-817e-4c65-9a46-e6b5f200470e 44873-002 HUMAN OTC DRUG Go Smile PM SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20110505 OTC MONOGRAPH FINAL part355 Go Smile, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 44873-003_3fbcea0f-a01c-43bc-8839-de4fb9a7050e 44873-003 HUMAN OTC DRUG Go Smile Lemonade SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20110505 OTC MONOGRAPH FINAL part355 Go Smile, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 44873-004_8a08de3a-6baf-4f2a-8f3e-5a66ebd48a37 44873-004 HUMAN OTC DRUG Go Smile Green Apple SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20110505 OTC MONOGRAPH FINAL part355 Go Smile, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 44873-005_24f95faf-26df-4cec-a01b-83d7941af1a9 44873-005 HUMAN OTC DRUG CLEAN AND POLISH LUXURY SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20120517 OTC MONOGRAPH FINAL part355 Go Smile, Inc. SODIUM MONOFLUOROPHOSPHATE .13 g/100g 44873-102_ebda576b-4685-4a2f-80f4-c6ded3063491 44873-102 HUMAN OTC DRUG TRULY WHITENING SYSTEM SODIUM MONOFLUOROPHOSPHATE KIT 20130515 OTC MONOGRAPH FINAL part355 Go Smile, Inc. 44911-0001_4bbf8d41-4c63-48c6-8aa2-a8a926e11a47 44911-0001 HUMAN OTC DRUG Arthritis HP Apis mellifica, Bryonia, Causticum, Colchicum autumnale, Kali carbonicum, Kalmia latifolia, Ledum palustre, Pulsatilla, Rhododendron chrysanthum, Rhus toxicodendron, LIQUID ORAL 20120423 UNAPPROVED HOMEOPATHIC Energique, Inc. APIS MELLIFERA; BRYONIA ALBA ROOT; CAUSTICUM; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; POTASSIUM CARBONATE; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0002_7f63b124-40c0-495c-b749-b7938294da98 44911-0002 HUMAN OTC DRUG GABA Phenolic Gamma-aminobutyric acid, LIQUID ORAL 20120427 UNAPPROVED HOMEOPATHIC Energique, Inc. .GAMMA.-AMINOBUTYRIC ACID 6 [hp_X]/mL 44911-0003_d75f5720-bca2-4785-92d2-187b9170e60a 44911-0003 HUMAN OTC DRUG Grippe HP Aconitum napellus, Arsenicum album, Baptisia tinctoria, Belladonna, Bryonia, Eupatorium perfoliatum, Ferrum Phosphoricum, Gelsemium sempervirens, LIQUID ORAL 20120427 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0004_c9e15fd0-02cb-4110-ab75-67f6f5fa1dab 44911-0004 HUMAN OTC DRUG BAC HP Apis mellifica, Arsenicum album, Belladonna, Chamomilla, Echinacea, Lachesis mutus, Mercurius solubilis, Pulsatilla, Pyrogenium, Rhus toxicodendron, Silicea, LIQUID ORAL 20120427 UNAPPROVED HOMEOPATHIC Energique, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0005_40299f6e-7d65-4182-9a93-bfa6693aac99 44911-0005 HUMAN OTC DRUG Allerstat I Chelidonium Majus, Echinacea, Gentiana Lutea, Arsenicum Album, Carbo Vegetablis, Lycopodium Clavatum LIQUID ORAL 20130311 UNAPPROVED HOMEOPATHIC Energique, Inc. ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED 12; 12; 3; 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0006_3331dbf9-64fb-450a-a39c-9972a64ba8ea 44911-0006 HUMAN OTC DRUG Dust Mix Antigens Barley, Corn, House, Mattress, Millet, Milo, Oat, Rice, Rug, Upholstery, Wheat, Arsenicum album, Blatta orientalis, Drosera, Lycopodium clavatum, Pothos foetidus, Pulsatilla, LIQUID ORAL 20120504 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; BARLEY; BLATTA ORIENTALIS; BROWN RICE; CORN; DROSERA ROTUNDIFOLIA; HOUSE DUST; LYCOPODIUM CLAVATUM SPORE; MILLET; OAT; PULSATILLA VULGARIS; SORGHUM; SYMPLOCARPUS FOETIDUS ROOT; WHEAT 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0007_b542f7de-4e28-4f7a-8b05-2ec8c6345ced 44911-0007 HUMAN OTC DRUG Bronchi HP Carbo vegetabilis, Cuprum metallicum Drosera, Hepar sulphuris calcareum, Ipecacuanha, Lachesis mutus, Lobelia inflata, Phosphorus, Pulsatilla, Rumex crispus, Spongia tosta, LIQUID ORAL 20120523 UNAPPROVED HOMEOPATHIC Energique, Inc. ACTIVATED CHARCOAL; CALCIUM SULFIDE; COPPER; DROSERA ANGLICA; IPECAC; LACHESIS MUTA VENOM; LOBELIA INFLATA; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0008_b16f0ea6-3db4-417e-bf8c-915aa408513c 44911-0008 HUMAN OTC DRUG Bactestat Baptisia tinctoria, Echinacea, Phytolacca decandra, Aconitum napellus, Arsenicum album, Belladonna, Ferrum phosphoricum, Lachesis mutus, Phosphorus, LIQUID ORAL 20120524 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; LACHESIS MUTA VENOM; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT 12; 12; 12; 3; 3; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0009_406b34b9-75b0-43be-a15a-8a945504c499 44911-0009 HUMAN OTC DRUG Parasite Detox Filix mas, Granatum, Juglans regia, Rhamnus purshiana, Absinthium, Aesculus hippocastanum, Arsenicum album, Baptisia tinctoria, Cina, Cuprum metallicum, Ipecacuanha, Lycopodium clavatum, Mercurius vivus, Nux vomica, LIQUID ORAL 20120619 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; ARTEMISIA CINA FLOWER; BAPTISIA TINCTORIA ROOT; COPPER; DRYOPTERIS FILIX-MAS ROOT; FRANGULA PURSHIANA BARK; HORSE CHESTNUT; IPECAC; JUGLANS REGIA FLOWERING TOP; KRAMERIA LAPPACEA ROOT; LYCOPODIUM CLAVATUM SPORE; MERCURY; PULSATILLA VULGARIS; PUNICA GRANATUM ROOT BARK; SANTONIN; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM; TOXICODENDRON PUBESCENS LEAF; WORMWOOD 15; 15; 15; 15; 3; 3; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0010_3e0395cc-63f5-4c14-a9b9-40b14a558566 44911-0010 HUMAN OTC DRUG Liver Gallbladder HP Belladonna, Carduus Marianus, Chelidonium Majus, Colocynthis, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus, Pulsatilla, Veratrum Album LIQUID ORAL 20120628 UNAPPROVED HOMEOPATHIC Energique, Inc. ATROPA BELLADONNA; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0011_ab628a94-9c21-4fa5-97a1-c7910cbeb31a 44911-0011 HUMAN PRESCRIPTION DRUG Animal Antigens Canary feathers, Cat hair, Cattle epithelia, Chicken feathers, Dog epithelia, Duck feathers, Gerbil epithelia, Goat epithelia, Goose feathers, LIQUID ORAL 20120803 UNAPPROVED HOMEOPATHIC Energique, Inc. ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ARSENIC TRIOXIDE; BOS TAURUS SKIN; CANIS LUPUS FAMILIARIS SKIN; CAPRA HIRCUS SKIN; CAVIA PORCELLUS SKIN; EQUUS CABALLUS SKIN; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; MELOPSITTACUS UNDULATUS FEATHER; MERIONES UNGUICULATUS SKIN; MESOCRICETUS AURATUS SKIN; MUS MUSCULUS SKIN; ORYCTOLAGUS CUNICULUS SKIN; PHOSPHORUS; RATTUS NORVEGICUS SKIN; SERINUS CANARIA FEATHER; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA SKIN 9; 9; 12; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 9; 9; 12; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient] 44911-0012_581ba8f6-4370-4d82-91c7-efae9b8d2da6 44911-0012 HUMAN OTC DRUG Lyme HP Baptisia tinctoria, Echinacea, Hydrastis canadensis, Lym D Nosode, Arsenicum album, Bryonia, Chelidonium majus, Colchicum autumnale, Kalmia latifolia, Ledum palustre, Lycopodium clavatum, Phosphorus, Rhus toxicodendron, LIQUID ORAL 20120620 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BORRELIA BURGDORFERI; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; ECHINACEA, UNSPECIFIED; GOLDENSEAL; HEPATITIS B VIRUS; JAPANESE ENCEPHALITIS VIRUS; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; NEISSERIA MENINGITIDIS; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 30; 3; 12; 30; 30; 30; 3; 3; 12; 12; 30; 30; 30; 12; 30; 30 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 44911-0013_848467f3-9859-47aa-9af8-21914a2392c5 44911-0013 HUMAN OTC DRUG Quercetin Phenolic Quercetin, LIQUID ORAL 20120605 UNAPPROVED HOMEOPATHIC Energique, Inc. QUERCETIN 6 [hp_X]/mL 44911-0014_d4b46ebc-4f8c-4d84-a62d-4d4e4a2a3338 44911-0014 HUMAN OTC DRUG SP Brosimum Acutifolium Bark, Himatanthus Sucuuba Bark, Mansoa Alliacea Bark and Leaf, Minquartia Guianenis Bark, Phyllanthus Niruri Whole LIQUID ORAL 20130912 UNAPPROVED HOMEOPATHIC Energique, Inc. BROSIMUM ACUTIFOLIUM BARK; HIMATANTHUS LANCIFOLIUS BARK; MANSOA ALLIACEA BARK; MANSOA ALLIACEA LEAF; MINQUARTIA GUIANENSIS BARK; PHYLLANTHUS NIRURI WHOLE; PIPER ADUNCUM LEAF 32; 32; 32; 32; 32; 32; 32 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0015_0c65f772-20d9-4374-b44d-eae02a83eb62 44911-0015 HUMAN OTC DRUG Allerstat II Baptisia tinctoria, Echinacea, Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Euphrasia officinalis, Natrum sulphuricum, Nux vomica, LIQUID ORAL 20120717 UNAPPROVED HOMEOPATHIC Energique, Inc. AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0016_99829ec8-5685-4893-b418-d3276c6e8cb2 44911-0016 HUMAN OTC DRUG Weed Grass Antigens Allium Cepa, Arsenicum Album, Nux Vomica, Pulsatilla, Alfalfa, Amaranthus, Bamboo, Cocklebur, Dandelion LIQUID ORAL 20120816 UNAPPROVED HOMEOPATHIC Energique, Inc. AGROSTIS STOLONIFERA POLLEN; ALFALFA; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARSENIC TRIOXIDE; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN; BAMBUSA VULGARIS LEAF; CHENOPODIUM ALBUM POLLEN; DACTYLIS GLOMERATA POLLEN; FESTUCA PRATENSIS POLLEN; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; LOLIUM PERENNE POLLEN; ONION; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; PULSATILLA VULGARIS; RED CLOVER; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE WHOLE; TRIFOLIUM REPENS FLOWER; XANTHIUM STRUMARIUM POLLEN 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0017_a3c53c94-671a-4e06-a02b-b67ccfa16bf2 44911-0017 HUMAN OTC DRUG Household Antigens Acetone, Sodium tripolyphosphate, Propylene glycol, Sodium benzene sulfonate, Sodium lauryl sulfate, Terebinthina, LIQUID ORAL 20120807 UNAPPROVED HOMEOPATHIC Energique, Inc. ACETONE; AMMONIUM CHLORIDE; BUTYL ACETATE; DIBUTYL PHTHALATE; ETHYL ACETATE; GRAPHITE; KEROSENE; NITRIC ACID; PROPYLENE GLYCOL; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SODIUM BENZENESULFONATE; SODIUM LAURYL SULFATE; SODIUM TRIPOLYPHOSPHATE; SULFUR; TOLUENE; TURPENTINE OIL; XYLENE 9; 9; 9; 9; 9; 12; 9; 12; 9; 12; 12; 9; 9; 9; 12; 9; 9; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0018_6a261766-2447-4a5c-81a6-bbdc9e6de09f 44911-0018 HUMAN OTC DRUG Asthma HP Arsenicum Album, Belladonna, Blatta Orientalis, Ipecacuanha, Kali Carbonicum, Lobelia Inflata, Natrum Sulphuricum, Silicea LIQUID ORAL 20120824 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLATTA ORIENTALIS; IPECAC; LOBELIA INFLATA; POTASSIUM CARBONATE; SILICON DIOXIDE; SODIUM SULFATE; SODIUM SULFATE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0019_b036e05a-0d7b-4cb8-a12c-0a6b819828b7 44911-0019 HUMAN OTC DRUG Adrenapar Aralia Quinoquefolia, Avena Sativa, Glandula Suparenalis Suis, Arsenicum Iodatum, Ignatia Amara, Lycopodium Clavatum, Nux Vomica LIQUID ORAL 20120820 UNAPPROVED HOMEOPATHIC Energique, Inc. AMERICAN GINSENG; ARSENIC TRIIODIDE; AVENA SATIVA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; ZINC 3; 12; 3; 12; 12; 12; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0021_2d604973-9905-4613-8ffa-f4a39e772241 44911-0021 HUMAN OTC DRUG Virustat Echinace, Hydrastis Canadensis, Lomatium Dissectum, Aconitum Napellus, Arsenicum Album, Belladonna, Eupatorium Perfoliatum, Gelsemium Sempervirens, LIQUID ORAL 20120824 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; LOMATIUM DISSECTUM ROOT; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3; 12; 3; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0022_88f0d1e7-80fc-417c-b905-4edc5f86844e 44911-0022 HUMAN OTC DRUG Multi Flower Agrimony, Aspen, Beech, Centaury, Cerato, Cherry Plum, Chestnut Bud, Chicory, Clematis, Crab Apple, Elm, Gentian, Gorse, Heather LIQUID ORAL 20120824 UNAPPROVED HOMEOPATHIC Energique, Inc. AESCULUS CARNEA FLOWER; AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA; BROMUS RAMOSUS FLOWER; CALLUNA VULGARIS FLOWERING TOP; CARPINUS BETULUS FLOWER; CASTANEA SATIVA FLOWER; CENTAURIUM ERYTHRAEA; CERATOSTIGMA WILLMOTTIANUM FLOWER; CICHORIUM INTYBUS FLOWER; CLEMATIS VITALBA FLOWER; FAGUS SYLVATICA FLOWERING TOP; GENTIANELLA AMARELLA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; IMPATIENS GLANDULIFERA FLOWER; LARIX DECIDUA FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWER; MALUS SYLVESTRIS FLOWER; MIMULUS GUTTATUS FLOWERING TOP; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM; PINUS SYLVESTRIS FLOWERING TOP; POPULUS TREMULA FLOWERING TOP; PRUNUS CERASIFERA FLOWER; QUERCUS ROBUR FLOWER; ROSA CANINA FLOWER; SALIX ALBA FLOWERING TOP; SCLERANTHUS ANNUUS FLOWERING TOP; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; ULEX EUROPAEUS FLOWER; ULMUS PROCERA FLOWERING TWIG; VERBENA OFFICINALIS FLOWERING TOP; VITIS VINIFERA FLOWERING TOP; WATER 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 44911-0023_b76cc105-c5bb-40c6-b14d-c30af698762b 44911-0023 HUMAN OTC DRUG BAC HP Apis Mellifica, Arsenicum Album, Belladonna, Chamomilla, Echinacea, Lachesis Mutus, Mercurius Solubilis LIQUID ORAL 20120827 UNAPPROVED HOMEOPATHIC Energique, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0024_086446c6-2209-42d5-8b90-fbc6a6bd9f3b 44911-0024 HUMAN OTC DRUG Fungustat I Echinacea, Tabebuia Impetiginosa, Abies Nigra, Lycopodium Clavatum, Nux Vomica, Phosporus, Pulsatilla LIQUID ORAL 20120827 UNAPPROVED HOMEOPATHIC Energique, Inc. CANDIDA ALBICANS; ECHINACEA, UNSPECIFIED; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PICEA MARIANA RESIN; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SKATOLE; STRYCHNOS NUX-VOMICA SEED; TABEBUIA IMPETIGINOSA BARK 30; 3; 12; 12; 12; 12; 12; 15; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0025_b6d609b6-1aa8-4c08-9472-5c737a56e9a5 44911-0025 HUMAN OTC DRUG Acetylcholine Chloride Phenolic Acetylcholine chloride, LIQUID ORAL 20121108 UNAPPROVED HOMEOPATHIC Energique, Inc. ACETYLCHOLINE CHLORIDE 6 [hp_X]/mL 44911-0026_20e9c537-6c01-48d0-a2d1-ab177df2d3d5 44911-0026 HUMAN OTC DRUG Lymphdrainex Geranium robertianum, Nasturtium aquaticum, Aloe socotrina, Juglans regia, Myosotis arvensis, Scrophularia nodosa, Teucrium scorodonia, Apis mellifica, Equisetum hyemale, Fumaria officinalis, LIQUID ORAL 20121107 UNAPPROVED HOMEOPATHIC Energique, Inc. ALOE; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; BOS TAURUS PARATHYROID GLAND; CALCIUM SULFIDE; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA LEAF; MERCURIC CYANIDE; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; SCROPHULARIA NODOSA; SMILAX REGELII ROOT; SODIUM SULFATE; SUS SCROFA THYMUS; TEUCRIUM SCORODONIA FLOWERING TOP; THYROID, PORCINE; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 3; 4; 12; 8; 12; 8; 4; 8; 4; 5; 3; 3; 8; 3; 3; 4; 4; 3; 6; 4; 12; 3; 12; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0027_059da017-7f77-4714-ac17-80706060e18a 44911-0027 HUMAN PRESCRIPTION DRUG Mold Antigens Arsenicum Album, Phosphorus, Pulsatilla, Sepia, Alternaria tenuis, Aspergillus niger, Rhizopus nigricans LIQUID ORAL 20121107 UNAPPROVED HOMEOPATHIC Energique, Inc. ALTERNARIA ALTERNATA; ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; PHOSPHORUS; PULSATILLA VULGARIS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 44911-0028_1fab4ac0-64b1-469d-b4cb-ce64d75e16a0 44911-0028 HUMAN OTC DRUG Bronchitone Echinacea, Lobelia Inflata, Antimonium Tartaricum, Aralia Racemosa, Drosera, Ipecacuanha, Kali Carbonicum LIQUID ORAL 20121107 UNAPPROVED HOMEOPATHIC Energique, Inc. ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; DROSERA ROTUNDIFOLIA; ECHINACEA ANGUSTIFOLIA; IPECAC; LOBELIA INFLATA; PHOSPHORUS; POTASSIUM CARBONATE; SPONGIA OFFICINALIS SKELETON, ROASTED 12; 12; 12; 3; 12; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0029_ae2c3d42-5392-49e7-bd2e-31a9d7f1ec62 44911-0029 HUMAN OTC DRUG Gastrotone Gentiana lutea, Sambucus nigra, Arsenicum album, Kali bichromicum, Lycopodium clavatum, Phosphorus, Pulsatilla, Bismuthum carbonicum, LIQUID ORAL 20121112 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; BISMUTH SUBCARBONATE; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SAMBUCUS NIGRA FLOWERING TOP 12; 15; 3; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 44911-0030_422b9ccd-3085-4cef-8921-3e7f5bd82115 44911-0030 HUMAN OTC DRUG ADD HP Gamma-aminobutyric acid, L-dopa, Norepinephrine, Serotonin, Adrenocorticotrophin, Anacardium orientale, Arsenicum album, Baryta carbonica, LIQUID ORAL 20121010 UNAPPROVED HOMEOPATHIC Energique, Inc. .GAMMA.-AMINOBUTYRIC ACID; ARSENIC TRIOXIDE; BARIUM CARBONATE; CORTICOTROPIN; DATURA STRAMONIUM; HYOSCYAMUS NIGER; LEVODOPA; LYCOPODIUM CLAVATUM SPORE; NOREPINEPHRINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEMECARPUS ANACARDIUM JUICE; SEROTONIN; TRIBASIC CALCIUM PHOSPHATE 6; 30; 30; 8; 30; 30; 6; 30; 6; 30; 30; 6; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 44911-0031_3911e0db-4f40-43bf-ba97-e410666d9629 44911-0031 HUMAN OTC DRUG Dentastat Allium sativum, Berberis vulgaris, Fucus vesiculosus, Phytolacca decandra, Argentum metallicum, Aurum metallicum, Calcarea fluorica, Calcarea phosphorica, Iodium, Mercurius solubilis, LIQUID ORAL 20121113 UNAPPROVED HOMEOPATHIC Energique, Inc. BERBERIS VULGARIS ROOT BARK; CALCIUM FLUORIDE; FUCUS VESICULOSUS; GARLIC; GOLD; IODINE; MERCURIUS SOLUBILIS; NICKEL; PHYTOLACCA AMERICANA ROOT; PLATINUM; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; ZINC 3; 12; 3; 3; 12; 12; 12; 12; 3; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0032_a0588cc6-aa3c-4dc3-9544-188bc6bb99df 44911-0032 HUMAN OTC DRUG Weed Grass Antigens Allium cepa, Arsenicum album, Nux vomica, Pulsatilla, Alfalfa, Amaranthus, Bamboo, Cocklebur, Dandelion, Goldenrod, Kentucky blue, Lambs quarter, LIQUID ORAL 20121008 UNAPPROVED HOMEOPATHIC Energique, Inc. AGROSTIS STOLONIFERA POLLEN; ALFALFA; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARSENIC TRIOXIDE; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN; BAMBUSA VULGARIS LEAF; CHENOPODIUM ALBUM POLLEN; DACTYLIS GLOMERATA POLLEN; FESTUCA PRATENSIS POLLEN; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; LOLIUM PERENNE POLLEN; ONION; PHLEUM PRATENSE POLLEN; POA PRATENSIS TOP; PULSATILLA VULGARIS; RUMEX ACETOSA WHOLE; RUMEX CRISPUS TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE POLLEN; TRIFOLIUM REPENS POLLEN; XANTHIUM STRUMARIUM POLLEN 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0033_b4716c3f-81c3-49b3-9716-c22a4275e725 44911-0033 HUMAN OTC DRUG Renastat Berberis Vulgaris, Petroselinum Sativum, Sabal Serrulata, Uva Ursi, CAntharis, Lithium Carbonicum, Mercurius Corrosivus LIQUID ORAL 20121004 UNAPPROVED HOMEOPATHIC Energique, Inc. ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; CHONDRODENDRON TOMENTOSUM ROOT; LITHIUM CARBONATE; LYTTA VESICATORIA; MERCURIC CHLORIDE; PETROSELINUM CRISPUM; SAW PALMETTO; SMILAX REGELII ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 3; 3; 12; 12; 12; 12; 3; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0034_cbded3d8-1346-4e46-ae7d-49cbb4835c2f 44911-0034 HUMAN OTC DRUG Parastat Artemisia Vulgaris, Cina, Filiz Mas, Sabadilla, Spigelia Anthelmia, Baryta Carbonica, Calcarea Carbonica LIQUID ORAL 20121002 UNAPPROVED HOMEOPATHIC Energique, Inc. ARTEMISIA CINA PRE-FLOWERING TOP; ARTEMISIA VULGARIS ROOT; BARIUM CARBONATE; DRYOPTERIS FILIX-MAS ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SCHOENOCAULON OFFICINALE SEED; SPIGELIA ANTHELMIA; SULFUR; TURPENTINE OIL 3; 3; 12; 3; 12; 3; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0035_e8613739-38b8-4b60-af6f-388a836d15f3 44911-0035 HUMAN OTC DRUG L Dopa Phenolic L Dopa LIQUID ORAL 20130219 UNAPPROVED HOMEOPATHIC Energique, Inc. LEVODOPA 6 [hp_X]/mL 44911-0036_7205250e-a7f3-4b65-a03f-517526103fd7 44911-0036 HUMAN OTC DRUG Sinutone Echinachea, Hydrastis Canadensis, Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Kali Bichromicum, Nux Moschata LIQUID ORAL 20121005 UNAPPROVED HOMEOPATHIC Energique, Inc. AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; NUTMEG; ONION; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SOLIDAGO VIRGAUREA FLOWERING TOP 12; 12; 12; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0037_951dd2c7-158c-4102-9382-a88a80aae714 44911-0037 HUMAN OTC DRUG Adrenapar Aralia Quinquefolia, Avena Sativa, Glandula Suprarenalis Suis, Arsenicum Iodatum, Ignatia Amara, Lycopodium Clavatum LIQUID ORAL 20121004 UNAPPROVED HOMEOPATHIC Energique, Inc. AMERICAN GINSENG; ARSENIC TRIIODIDE; AVENA SATIVA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; ZINC 3; 12; 3; 12; 12; 12; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0038_466bca69-e341-4793-9850-78075dbe9543 44911-0038 HUMAN PRESCRIPTION DRUG Anxiety Aconitum Napellus, Arsenicum Album, Belladonna, Calcarea Carbonica, Carcinosin, Causticum, Gelsemium Sempervirens LIQUID ORAL 20121016 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CAUSTICUM; GELSEMIUM SEMPERVIRENS ROOT; HUMAN BREAST TUMOR CELL; LACHESIS MUTA VENOM; MERCURY; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 44911-0039_c6e2c9f0-c204-487b-81a3-ecd654654b83 44911-0039 HUMAN PRESCRIPTION DRUG Liquid B Liquid B Homeopathic, Hordeum Vulgare, Hepar Suis, Heart (Suis), Torula Cerevisiae LIQUID ORAL 20121029 UNAPPROVED HOMEOPATHIC Energique, Inc. HORDEUM VULGARE TOP; PORK HEART; PORK LIVER; SACCHAROMYCES CEREVISIAE 2; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 44911-0042_b386d065-afee-4473-86a5-893190276fd3 44911-0042 HUMAN OTC DRUG Ferrum Phos Ferrum Phosphoricum LIQUID ORAL 20121002 UNAPPROVED HOMEOPATHIC Energique, Inc. FERRUM PHOSPHORICUM 30 [hp_C]/mL 44911-0043_757b24be-cd07-469b-a2c3-4503bcec3154 44911-0043 HUMAN OTC DRUG Diabenex HP Aceticum Acidum, Colchicum Autumnale, Lacticum Acidum, Lycopodium Clavatum, Phosphoricum Acidum, Phosphorus LIQUID ORAL 20121005 UNAPPROVED HOMEOPATHIC Energique, Inc. ACETIC ACID; COLCHICUM AUTUMNALE BULB; LACTIC ACID, DL-; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0044_feb5dff8-087c-4062-a340-005ebf8aa7bd 44911-0044 HUMAN OTC DRUG Anxiety HP Arsenicum album, Calcarea carbonica , Ignatia amara, Kali carbonicum, Lachesis mutus, Natrum muriaticum, Phosphous, Pulsatilla, Staphysagria, LIQUID ORAL 20121015 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; DELPHINIUM STAPHISAGRIA SEED; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0045_dd939ca7-5c61-4703-9c18-2dc8126db127 44911-0045 HUMAN OTC DRUG Terrestristat Alfalfa, Avena Sativa, Fucus Vesiculosus, Thyroidinum, Agate, Cadmium Iodatum, Calcarea Phosphorica LIQUID ORAL 20121022 UNAPPROVED HOMEOPATHIC Energique, Inc. ALCOHOL, X-RAY EXPOSED (1000 RAD); ALFALFA; AVENA SATIVA TOP; CADMIUM IODIDE; CITHARACANTHUS SPINICRUS; COPPER; FUCUS VESICULOSUS; PHOSPHORIC ACID; PHOSPHORUS; SILICON DIOXIDE; STRONTIUM CARBONATE; THYROID, PORCINE; TRIBASIC CALCIUM PHOSPHATE; URANYL NITRATE HEXAHYDRATE 30; 3; 3; 12; 30; 12; 3; 12; 12; 3; 12; 6; 12; 30 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0046_f1cb2c24-dfcb-42a3-a4bc-5f2318ce5ad3 44911-0046 HUMAN OTC DRUG Sinuchron HP Arsenicum album, Hepar sulphuris calcareum, Hydrastis canadensis, Kali bichromicum, Lycopodium clavatum, Mercurius solubilis, Natrum muriaticum, Phosphorus, Pulsatilla, Sepia Thuja occidentalis, LIQUID ORAL 20121015 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; CALCIUM SULFIDE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0047_b3a36318-fadb-4db6-b473-88407ce3acb3 44911-0047 HUMAN OTC DRUG Progesterone Phenolic Progesterone LIQUID ORAL 20130311 UNAPPROVED HOMEOPATHIC Energique, Inc. PROGESTERONE 6 [hp_X]/mL 44911-0048_9eae9a22-a401-4bb0-8f14-0841bf482618 44911-0048 HUMAN PRESCRIPTION DRUG Lyme HP Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Lym D Nosode, Arsenicum Album, Bryonia, Chelidonium Majus LIQUID ORAL 20121129 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BORRELIA BURGDORFERI; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HEPATITIS B VIRUS; JAPANESE ENCEPHALITIS VIRUS; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; NEISSERIA MENINGITIDIS; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 30; 3; 12; 30; 30; 30; 3; 3; 12; 12; 30; 30; 30; 12; 30; 30 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 44911-0049_4d019508-1a28-4ecd-9bbd-5d107b6a8606 44911-0049 HUMAN PRESCRIPTION DRUG Anpituapar Adrenocorticotrophin, Agnus Castus, Baryta Castus, Baryta Carbonica, Calcarea Carbonica, Iodium, Lac Caninum, LIQUID ORAL 20121029 UNAPPROVED HOMEOPATHIC Energique, Inc. BARIUM CARBONATE; CANIS LUPUS FAMILIARIS MILK; CHASTE TREE; CORTICOTROPIN; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; SUS SCROFA THYROID 12; 12; 12; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] 44911-0050_f43c3458-2e4d-4a8c-bf93-36798ef9067b 44911-0050 HUMAN PRESCRIPTION DRUG Biting Insect Antigens Cimex lectularius, Formica rufa, Pulex irritans, Vespa crabro, Apis Mellifica, Hypericum Perforatum, Ledum Palustre LIQUID ORAL 20121031 UNAPPROVED HOMEOPATHIC Energique, Inc. APIS MELLIFERA; CIMEX LECTULARIUS; FORMICA RUFA; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PULEX IRRITANS; VESPA CRABRO 12; 15; 15; 12; 12; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 44911-0051_50bb8aca-4545-4a40-90c2-c10a82d33cd7 44911-0051 HUMAN OTC DRUG Otoflam HP Belladonna, Conium Maculatum, Dulcamara, Ferrum Phosphoricum, Hepar Sulphuris Calcareum, Kali Bichromicum LIQUID ORAL 20121126 UNAPPROVED HOMEOPATHIC Energique, Inc. ATROPA BELLADONNA WHOLE; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SOLANUM DULCAMARA TOP 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0052_020b68d2-d3a3-477e-8865-e5b1eff0f156 44911-0052 HUMAN OTC DRUG Infect HP Aconitum Napellus, Arsenicum Album, Baptisia Tinctoria, Belladonna, Bryonia, Causticum, Echinacea, Eupatorium Perfoliatum LIQUID ORAL 20121217 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAUSTICUM; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; SODIUM SULFATE; SULFUR; SUS SCROFA LUNG; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0053_f0954931-4ec0-4287-99a7-c3f933245f4b 44911-0053 HUMAN OTC DRUG ALZ HP Anacardium Orientale, Belladonna, Hyoscyamus Niger, Kali Bromatum, Veratrum Album, Baryta Carbonica, Lachesis Mutus LIQUID ORAL 20121116 UNAPPROVED HOMEOPATHIC Energique, Inc. ATROPA BELLADONNA WHOLE; BARIUM CARBONATE; DATURA STRAMONIUM; HYOSCYAMUS NIGER; LACHESIS MUTA VENOM; PHOSPHORUS; POTASSIUM BROMIDE; SEMECARPUS ANACARDIUM JUICE; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0054_79e15d55-f3ba-4dc3-84fe-6728a928efe5 44911-0054 HUMAN OTC DRUG Bactestat Baptisia Tinctoria, Echinacea, Phytolacca Decandra, Aconitum Napellus, Arsenicum Album, Belladonna, Ferrum Phosphoricum LIQUID ORAL 20121126 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; BAPTISIA TINCTORIA; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; LACHESIS MUTA VENOM; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT 12; 12; 12; 3; 3; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0055_d8142398-6fba-414d-867b-e7d2f005cd2b 44911-0055 HUMAN OTC DRUG Envirostat Berberis Vulgaris, Chelidonium Majus, Lappa Major, Phytolacca Decandra, Calcarea Fluorica, Carbo Animalis, Nux Vomica LIQUID ORAL 20121218 UNAPPROVED HOMEOPATHIC Energique, Inc. ARCTIUM LAPPA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM FLUORIDE; CARBO ANIMALIS; CHELIDONIUM MAJUS; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAF 3; 3; 12; 12; 3; 12; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0056_1577e2c9-6652-4619-86d6-3e3ef1513248 44911-0056 HUMAN OTC DRUG Intestipar Gentiana Lutea, Arsenicum Album, Cinchona Officinalis, Colocynthis, Nux Vomica, Phosphorus, Intestinal Mucosa LIQUID ORAL 20121218 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; BOS TAURUS INTESTINAL MUCOSA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; GENTIANA LUTEA ROOT; PHOSPHORUS; STRYCHNOS NUX-VOMICA SEED 12; 30; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0057_54d7827d-7553-4558-ac48-e283fb58310b 44911-0057 HUMAN OTC DRUG Thyroid HP Baryta Carbonica, Calcarea Carbonica, Calcarea Iodata, Fucus Vesiculosus, Iodium, Natrum Muriaticum, Pulsatilla LIQUID ORAL 20121203 UNAPPROVED HOMEOPATHIC Energique, Inc. BARIUM CARBONATE; CALCIUM IODIDE; FUCUS VESICULOSUS; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0058_c3b547d6-7af2-4871-9e01-a7fa7559027b 44911-0058 HUMAN OTC DRUG Thyrostat Fucus Vesiculosus, Spongia Tosta, Pituitaria Glandula, Thyroidinum, Arsenicum Iodatum, Baryta Carbonica LIQUID ORAL 20121203 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIIODIDE; BARIUM CARBONATE; FUCUS VESICULOSUS; IODINE; LYCOPUS VIRGINICUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID 12; 12; 3; 12; 12; 12; 12; 3; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0059_ab3b2d4d-c79a-4b19-bb67-626f61d6ddea 44911-0059 HUMAN OTC DRUG Rescue 5 Cherry Plum, Clematis, Impatiens, Rock Rose, Star of Bethlehem LIQUID ORAL 20130326 UNAPPROVED HOMEOPATHIC Energique, Inc. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 44911-0060_17276afc-aeaa-46f2-8d73-de32c6c823f0 44911-0060 HUMAN OTC DRUG HZ HP Lycopodicum Clavatum, Mezereum, Natrum Muriaticum, Nitricum Acidum, Ranunculus Bulbosus, Rhus Toxicodendron, Sepia LIQUID ORAL 20121219 UNAPPROVED HOMEOPATHIC Energique, Inc. DAPHNE MEZEREUM BARK; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0061_7ecb2d33-2dd9-4f76-ae0d-d89f72c1baef 44911-0061 HUMAN OTC DRUG Rescue 5 Cherry Plum, Clematis, Impatiens, Rose Rose, Star of Bethlehem LIQUID ORAL 20121227 UNAPPROVED HOMEOPATHIC Energique, Inc. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 44911-0062_1c93b52b-03ca-4109-9de6-aac07a9c026e 44911-0062 HUMAN OTC DRUG Hepapar Carduus Marianus, Chelidonium Majus, Taraxacum Officinale, Chenopodium Anthelminticum, Hepar Suis, Lycopodium Clavatum LIQUID ORAL 20130104 UNAPPROVED HOMEOPATHIC Energique, Inc. CHELIDONIUM MAJUS; DYSPHANIA AMBROSIOIDES; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHOSPHORUS; PORK LIVER; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 3; 6; 12; 12; 12; 6; 3; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0063_628d9ac9-ed78-4ec3-9fe9-cc5245bc9c0b 44911-0063 HUMAN OTC DRUG Lymphapar Echinacea, Phytolacca Decandra, Lymph Node, Conium Maculatum, Ferrum Iodatum, Hepar Sulphuris Calcareum , Ferrum Iodatum LIQUID ORAL 20130103 UNAPPROVED HOMEOPATHIC Energique, Inc. CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; FERROUS IODIDE; LACHESIS MUTA VENOM; PHYTOLACCA AMERICANA ROOT; POTASSIUM CHLORIDE; SILICON DIOXIDE; SUS SCROFA LYMPH 12; 12; 3; 12; 12; 3; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0064_82325959-efdc-414e-a5e9-381cf5df96e1 44911-0064 HUMAN OTC DRUG Traumatone Calendula Officinalis, Symphytum Officinale, Arnica Montana, Bellis Perennis, Hypericum Perforatum, Ledum Palustre LIQUID ORAL 20130219 UNAPPROVED HOMEOPATHIC Energique, Inc. ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; STRONTIUM CARBONATE; TOXICODENDRON PUBESCENS LEAF 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0065_9a8a273b-b5fe-4883-a54a-163b6cb0d379 44911-0065 HUMAN OTC DRUG Virustat Echinacea, Hydrastis Canadensis, Lomatium Dissectum, Aconitum Napellus, Arsenicum Album, Belladonna LIQUID ORAL 20120219 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; LOMATIUM DISSECTUM ROOT; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3; 12; 3; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0066_fe38c973-9ac4-450c-a240-b647014f5326 44911-0066 HUMAN OTC DRUG Infectistat Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Lobelia Inflata, Lomatium Dissectum, Phytolacca Decandra LIQUID ORAL 20130102 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CAUSTICUM; COMFREY ROOT; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; SODIUM SULFATE; SULFUR; SUS SCROFA LUNG; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3; 3; 12; 12; 12; 3; 12; 12; 3; 3; 12; 3; 12; 12; 30; 12; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0067_8bff975a-b0da-42f0-8e08-bdf3e5d9fde0 44911-0067 HUMAN OTC DRUG Bone Repair HP Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Hekla Lava, Hydrofluoricum Acidum, Magnesia Phosphorica LIQUID ORAL 20130220 UNAPPROVED HOMEOPATHIC Energique, Inc. CALCIUM FLUORIDE; COMFREY ROOT; HEKLA LAVA; HYDROFLUORIC ACID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0068_2c1bcddf-a86f-45be-80c4-b8b3c0cbd95d 44911-0068 HUMAN OTC DRUG Allerpoll HP Allium Cepa, Ambrosia Artemisiaefolia, Apis Mellfica, Arsenic Album, Euphrasia Officinalis, Nux Vomica, Phosphorus, Pulsatilla LIQUID ORAL 20130912 UNAPPROVED HOMEOPATHIC Energique, Inc. AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0069_c83bf209-7eae-4122-b2d9-867079d42fb1 44911-0069 HUMAN OTC DRUG Hypothalmupar Aralia Quinquefolia, Ginkgo Biloba, Hydrocotyle Asiatica, Brain, Hypothalamus, Pituitaria Glandula, Phosphorus, Silicea LIQUID ORAL 20130102 UNAPPROVED HOMEOPATHIC Energique, Inc. AMERICAN GINSENG; CENTELLA ASIATICA; GINKGO; PHOSPHORUS; PORK BRAIN; SILICON DIOXIDE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND 3; 3; 3; 12; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0070_47e7ca59-62af-4f9c-962a-cd8bfe3a6c2d 44911-0070 HUMAN OTC DRUG Hepastat Beta Vulgaris, Carduus Marianus, Taraxacum Officinale, Cholesterinum, Fel Tauri, Chelidonium Majus, Lycopodium Clavatum LIQUID ORAL 20130411 UNAPPROVED HOMEOPATHIC Energique, Inc. BETA VULGARIS; BOS TAURUS BILE; CHELIDONIUM MAJUS; CHOLESTEROL; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 3; 6; 12; 6; 12; 12; 3; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0071_a5efb6af-cd6b-4eaf-9700-bc82767b1665 44911-0071 HUMAN OTC DRUG Headache HP Belladonna, Bryonia, Gelsemium Sempervirens, Glonoinum, Melilotus Officinalis, Natrum Muriaticum LIQUID ORAL 20130306 UNAPPROVED HOMEOPATHIC Energique, Inc. ATROPA BELLADONNA WHOLE; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; MELILOTUS OFFICINALIS TOP; NITRIC ACID; NITROGLYCERIN; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0072_b2c487fa-1cbd-4f4e-b078-7a72ea8fde68 44911-0072 HUMAN OTC DRUG Allerstat II Baptisia Tinctoria, Echinacea, Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Euphrasia Officinalis LIQUID ORAL 20130326 UNAPPROVED HOMEOPATHIC Energique, Inc. AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; EUPHRASIA STRICTA; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0073_d3577e77-37f7-48cd-8cbb-068d58ef89cf 44911-0073 HUMAN OTC DRUG Gastropanpar Pancreas, Stomach, Arsenicum Album, Graphites, Lycopodium Clavatum, Nuv Vomica, Phosphorus, Syzygium Jambolanum LIQUID ORAL 20130325 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; SYZYGIUM CUMINI SEED 12; 12; 12; 12; 12; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0074_fa8e82c9-f049-48fe-a905-3543f1850457 44911-0074 HUMAN OTC DRUG Nausea Vomitting HP Aethusa Cynapium, Arsenicum Album, Cocculus Indicus, Ipecacuanha, Kreosotum, Petroleum, Pulsatilla LIQUID ORAL 20130326 UNAPPROVED HOMEOPATHIC Energique, Inc. AETHUSA CYNAPIUM; ANAMIRTA COCCULUS SEED; ARSENIC TRIOXIDE; IPECAC; PETROLATUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; TOBACCO LEAF; WOOD CREOSOTE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0075_5b166a19-d1fa-4713-9fe6-3a1c65b7f300 44911-0075 HUMAN OTC DRUG Pancreapar Hydrastis Canadensis, Syzygium Jambolanum, Glandula Suprarenalis Suis, Pancreas Suis, Pituitary, Phaseolus LIQUID ORAL 20130411 UNAPPROVED HOMEOPATHIC Energique, Inc. ACETIC ACID; GOLDENSEAL; KIDNEY BEAN; LACTIC ACID; PHOSPHORIC ACID; PHOSPHORUS; SUS SCROFA ADRENAL GLAND; SUS SCROFA PANCREAS; SUS SCROFA PITUITARY GLAND; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 12; 3; 9; 12; 12; 12; 6; 6; 6; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0076_055c78a4-0a50-4a2e-b6ed-f8e4b50eeb34 44911-0076 HUMAN OTC DRUG Lymphdrainex Geeranium Robertianum, Nasturtium Aquaticum, Aloe Socotrina, Juglans Regia, Myosotis Arvensis, Scrophularia Nodosa LIQUID ORAL 20130411 UNAPPROVED HOMEOPATHIC Energique, Inc. ALOE; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; BOS TAURUS PARATHYROID GLAND; CALCIUM SULFIDE; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MERCURIC CYANIDE; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; SARSAPARILLA; SCROPHULARIA NODOSA; SODIUM SULFATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 3; 4; 12; 8; 12; 8; 4; 8; 4; 5; 3; 3; 3; 8; 3; 3; 4; 4; 6; 3; 4; 12; 12; 3; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0077_b482318f-1479-4642-a343-64c39c489783 44911-0077 HUMAN OTC DRUG Relaxatone Passiflora Incarnata, Scutellaria Lateriflora, Valeriana Officinalis, Arsenicum Album, Calcarea Carbonica, Coffea Cruda LIQUID ORAL 20130412 UNAPPROVED HOMEOPATHIC Energique, Inc. ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; DELPHINIUM STAPHISAGRIA SEED; LYCOPUS VIRGINICUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; SCUTELLARIA LATERIFLORA; STRYCHNOS IGNATII SEED; VALERIAN 12; 12; 12; 12; 12; 3; 12; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0078_b521ec49-c754-4777-b9eb-b23c720aecdd 44911-0078 HUMAN OTC DRUG Tinnitus HP Ginkgo Biloba, Chininum Sulphuricum, Cinchona Officinalis, Graphites, Natrum Salicylicum, Plumbum Metallicum LIQUID ORAL 20130412 UNAPPROVED HOMEOPATHIC Energique, Inc. ALLYLTHIOUREA; CINCHONA OFFICINALIS BARK; GINKGO; GRAPHITE; LEAD; QUININE SULFATE; SALICYLIC ACID; SODIUM SALICYLATE; SPIGELIA ANTHELMIA 30; 30; 6; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0079_9b2ba9c2-dac9-4bc5-9047-8a0f0eda5b18 44911-0079 HUMAN OTC DRUG PMS Tone Angelica Archangelica, Cimicifuga Racemosa, Fucus Vesiculosus, Cuprum Metallicum, Lac Caninum, Lachesis Mutus LIQUID ORAL 20130501 UNAPPROVED HOMEOPATHIC Energique, Inc. ANGELICA ARCHANGELICA ROOT; BLACK COHOSH; CANIS LUPUS FAMILIARIS MILK; COPPER; FUCUS VESICULOSUS; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE 3; 3; 12; 12; 3; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0080_25d80027-9574-451b-94bd-fe05d6a060dd 44911-0080 HUMAN OTC DRUG Flutone Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Phytolacca Decandra, Arsenicum Album, Bryonia, Eupatorium Perfoliatum LIQUID ORAL 20130423 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; IPECAC; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF 12; 3; 12; 3; 12; 12; 12; 3; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0081_cac60922-de0d-4771-8c2d-bf401ee7ac79 44911-0081 HUMAN OTC DRUG Anas Barbariae Anas Barbariae LIQUID ORAL 20130425 UNAPPROVED HOMEOPATHIC Energique, Inc. CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/mL 44911-0082_666b1c54-e2bd-4e56-ba5e-747e3277ba37 44911-0082 HUMAN OTC DRUG Thymupar Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Thymus, Arsenicum Album, Belladonna, Hepar Sulphuris Calcareum LIQUID ORAL 20130501 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; IRIDIUM; LACHESIS MUTA VENOM; SUS SCROFA THYMUS 12; 12; 3; 12; 3; 3; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0083_190f2e70-0868-42f1-9244-e042754ae08c 44911-0083 HUMAN OTC DRUG Infectistat Baptisia Tinctoria, Echinacea, Hydrastis Candensis, Lobelia Inflata, Lomatium Dissectum, Phytolacca Decandra, LIQUID ORAL 20130501 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAUSTICUM; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; SODIUM SULFATE; SULFUR; SUS SCROFA LUNG; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3; 3; 12; 12; 12; 3; 12; 12; 3; 3; 12; 3; 12; 12; 30; 12; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0084_e8ed2833-caa9-424d-9a3a-f70a49630a3c 44911-0084 HUMAN OTC DRUG Thyropar Fucus Vesiculosus, Spongia Tosta, Glandula Suprarenalis Suis, Pituitary, Thyroidinum, Bromium, Calcarea Carbonica LIQUID ORAL 20130501 UNAPPROVED HOMEOPATHIC Energique, Inc. BROMINE; FUCUS VESICULOSUS; IODINE; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID 12; 3; 12; 12; 12; 12; 3; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0085_51fb17c9-8190-4406-8cef-8817df685bbd 44911-0085 HUMAN OTC DRUG Thyropar Fucus Vesiculosus, Spongia Tosta, Glandula Suprarenalis Suis, Pituitaria Glandula (Suis), Thyroidinum (Suis), Bromium, Calcarea Carbonica LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC Energique, Inc. BROMINE; FUCUS VESICULOSUS; IODINE; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID 12; 3; 12; 12; 12; 12; 3; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0086_705307b9-c318-4cce-979d-d5eaf5edc983 44911-0086 HUMAN OTC DRUG Cystotone Sarsaparilla, UvaUrsi, Arsenicum Album, Cantharis, Pareira Brava, Pulsatilla, Sepia, Terebinthina, Populus Tremuloides LIQUID ORAL 20130815 UNAPPROVED HOMEOPATHIC Energique, Inc. ARCTOSTAPHYLOS UVA-URSI LEAF; ARSENIC TRIOXIDE; CHONDRODENDRON TOMENTOSUM ROOT; LYTTA VESICATORIA; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; PULSATILLA VULGARIS; SARSAPARILLA; SEPIA OFFICINALIS JUICE; TURPENTINE OIL 3; 12; 12; 12; 15; 15; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0087_470d850e-e251-4510-af25-a19f8b95491b 44911-0087 HUMAN OTC DRUG Terrestristat Alfalfa, Avena Sativa, Fucus Vesiculosus, Thyroidinum (Suis), Agate, Cadmium Iodatum, Calcarea Phosphorica, Cuprum Metallicum LIQUID ORAL 20130912 UNAPPROVED HOMEOPATHIC Energique, Inc. ALCOHOL, X-RAY EXPOSED (1000 RAD); ALFALFA; AVENA SATIVA FLOWERING TOP; CADMIUM IODIDE; CITHARACANTHUS SPINICRUS; COPPER; FUCUS VESICULOSUS; PHOSPHORIC ACID; PHOSPHORUS; SILICON DIOXIDE; STRONTIUM CARBONATE; SUS SCROFA THYROID; TRIBASIC CALCIUM PHOSPHATE; URANYL NITRATE HEXAHYDRATE 30; 3; 3; 12; 30; 12; 3; 12; 12; 12; 12; 6; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0088_80ae9e33-716f-43aa-9111-32f445e43096 44911-0088 HUMAN OTC DRUG TSH CORD Thyroid Stimulating Hormone (Bovine) LIQUID ORAL 20130815 UNAPPROVED HOMEOPATHIC Energique, Inc. THYROTROPIN 6 [hp_X]/mL 44911-0089_6867cf9b-ab24-4065-b1e8-8c2a9f32f5db 44911-0089 HUMAN OTC DRUG Cold HP Aconitum Napellus, Allium Cepa, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Kali Bichromicum, LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; MERCURIUS SOLUBILIS; ONION; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0090_840cd3af-880b-43c0-9ff6-98a616404cb5 44911-0090 HUMAN OTC DRUG Star of Bethlehem 30C Star of Bethlehem LIQUID ORAL 20130822 UNAPPROVED HOMEOPATHIC Energique, Inc. ORNITHOGALUM UMBELLATUM 30 [hp_C]/mL 44911-0091_51ad43b2-7f2f-48c2-83e6-62ba5302af71 44911-0091 HUMAN OTC DRUG Grain and Seed Antigens Bamboo, Barley, Corn, Levant Cotton, Flax, Millet, Milo, Oat, California Poppy, Rice, Rye, Safflower, Sesame, Sorghum, Soy Bean, Sugarcane LIQUID ORAL 20130918 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; BARLEY; BROWN RICE; CORN; ESCHSCHOLZIA CALIFORNICA; FLAX SEED; LEVANT COTTON SEED; LOPHATHERUM GRACILE LEAF; LYCOPODIUM CLAVATUM SPORE; MILLET; OAT; RYE; SAFFLOWER; SESAME SEED; SODIUM CHLORIDE; SORGHUM; SORGHUM BICOLOR WHOLE; SOYBEAN; SUGARCANE; SULFUR; SUNFLOWER SEED; WHEAT 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0093_3750f867-636f-44c1-8606-3b4842d09f5c 44911-0093 HUMAN OTC DRUG Oak 30C Quercus Robur LIQUID ORAL 20140616 UNAPPROVED HOMEOPATHIC Energique, Inc. QUERCUS ROBUR FLOWER 30 [hp_C]/mL 44911-0094_8c17b039-ba3c-49a0-a49f-da19c8f4c0da 44911-0094 HUMAN OTC DRUG Endopar M Aralia racemosa, Sabal serrulata, Glandula suprarenalis suis, Orchitinum suis, Pituitaria glandula suis, Prostrate suis, Agnus castus, LIQUID ORAL 20131030 UNAPPROVED HOMEOPATHIC Energique, Inc. ARALIA RACEMOSA ROOT; CHASTE TREE; CLEMATIS RECTA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SAW PALMETTO; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; SUS SCROFA TESTICLE; THUJA OCCIDENTALIS LEAF 3; 12; 12; 12; 12; 3; 6; 6; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0096_e9bd6bd4-509a-4e84-8ffc-f1830cf05dc6 44911-0096 HUMAN PRESCRIPTION DRUG Recovatone Glycyrrhiza glabra, Kali muriaticum, Magnesia muriatica, Zincum gluconicum, Kali phosphoricum, Natrum muriaticum, Iodium Phosphorus, Adrenalinum, LIQUID ORAL 20130709 UNAPPROVED HOMEOPATHIC Energique, Inc. ARGININE; ASCORBIC ACID; BORON; CALCIUM GLUCONATE; CHROMIUM; COBALTOUS GLUCONATE; COPPER GLUCONATE; CORTICOTROPIN; CREATINE; EPINEPHRINE; FERROUS GLUCONATE; GLUTAMINE; GLYCYRRHIZA GLABRA; IODINE; LEUCINE; LEVOCARNITINE; MAGNESIUM CHLORIDE; MAGNESIUM GLUCONATE; MANGANESE GLUCONATE; MOLYBDENUM; NICKEL; ORNITHINE; PHOSPHORUS; POTASSIUM CHLORIDE; POTASSIUM GLUCONATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; SELENIUM DIOXIDE; SODIUM CHLORIDE; STRONTIUM CARBONATE; TRIBASIC CALCIUM PHOSPHATE; VALINE; VANADIUM; ZINC GLUCONATE 6; 6; 12; 6; 8; 6; 6; 6; 6; 6; 6; 6; 1; 4; 6; 6; 2; 6; 6; 8; 8; 6; 5; 2; 6; 3; 8; 8; 3; 8; 9; 6; 8; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Carnitine [Chemical/Ingredient],Carnitine Analog [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 44911-0097_fde517ab-34b1-407d-b8aa-fcd65b8d1607 44911-0097 HUMAN PRESCRIPTION DRUG Psorinum Psorinum LIQUID ORAL 20141209 UNAPPROVED HOMEOPATHIC Energique, Inc. SCABIES LESION LYSATE (HUMAN) 7 [hp_X]/mL 44911-0098_eff08e5a-3455-492b-88b7-4d9aeb574c35 44911-0098 HUMAN OTC DRUG Vascular HP Aesculus hippocastanum, Collinsonia canadensis, Echinacea, Hamamelis virginiana, Pulsatilla (Vulgaris), Arnica montana, Carbo vegetabilis, Graphittes, LIQUID ORAL 20140224 UNAPPROVED HOMEOPATHIC Energique, Inc. ACTIVATED CHARCOAL; ARNICA MONTANA; COLLINSONIA CANADENSIS ROOT; ECHINACEA, UNSPECIFIED; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROFLUORIC ACID; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PAEONIA OFFICINALIS WHOLE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED 12; 12; 3; 3; 12; 3; 3; 12; 12; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0099_b2f99cb9-0b4c-4ef8-95cd-63cf2db11b2b 44911-0099 HUMAN OTC DRUG ADD HP Gaba, L-Dopa, Norepinephrine, Serotonin, Adrenocorticotrophin, Anacardium Orientale, Arsenicum Album, Baryta Carbonica, Calcarea Carbonica, Calcarea Phosphorica, Hyoscyamus Niger, Lycopodium Clavatum LIQUID ORAL 20140710 UNAPPROVED HOMEOPATHIC Engergique, Inc. .GAMMA.-AMINOBUTYRIC ACID; ANACARDIUM OCCIDENTALE FRUIT; ARSENIC TRIOXIDE; BARIUM CARBONATE; CORTICOTROPIN; DATURA STRAMONIUM; HYOSCYAMUS NIGER; LEVODOPA; LYCOPODIUM CLAVATUM SPORE; NOREPINEPHRINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEROTONIN HYDROCHLORIDE; TRIBASIC CALCIUM PHOSPHATE 6; 30; 30; 30; 8; 30; 30; 6; 30; 6; 30; 6; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 44911-0100_94ffdad8-9b58-4016-86c6-5952ac5972c3 44911-0100 HUMAN OTC DRUG PARASITE DETOX NOT APPLICABLE LIQUID ORAL 20140929 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; ARTEMISIA CINA PRE-FLOWERING TOP; BAPTISIA TINCTORIA; COPPER; DRYOPTERIS FILIX-MAS ROOT; FRANGULA PURSHIANA BARK; HORSE CHESTNUT; IPECAC; JUGLANS REGIA LEAF; KRAMERIA LAPPACEA ROOT; LYCOPODIUM CLAVATUM SPORE; MERCURY; PULSATILLA VULGARIS; PUNICA GRANATUM ROOT BARK; SANTONIN; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM; TOXICODENDRON PUBESCENS LEAF; WORMWOOD 15; 15; 15; 15; 3; 3; 15; 15; 5; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0101_b8735e23-433c-4025-a1c0-656463830f81 44911-0101 HUMAN OTC DRUG Lymphdrainex Geranium robertianum, Nasturtium aquaticum, Aloe socotrina, Myosotis arvensis, Scrophularia nodosa, Teucrium scorodonia, Apis mellifica, Equisteum hyemale, LIQUID ORAL 20140527 UNAPPROVED HOMEOPATHIC Energique, Inc. ALOE; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; BOS TAURUS PARATHYROID GLAND; CALCIUM SULFIDE; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MERCURIC CYANIDE; MYOSOTIS ARVENSIS; NASTURTIUM AQUATICUM; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; SARSAPARILLA; SCROPHULARIA NODOSA; SODIUM SULFATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 3; 4; 12; 8; 12; 8; 4; 8; 4; 5; 3; 5; 5; 8; 3; 3; 4; 4; 6; 3; 4; 12; 12; 3; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0102_0e8bbea7-37ce-431b-9114-3f05a60ed8fc 44911-0102 HUMAN PRESCRIPTION DRUG LYMPHDRAINEX Geranium Robertianum, Nasturtium Aquaticum, Aloe Socotrina, Mysotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia LIQUID ORAL 20130808 UNAPPROVED HOMEOPATHIC Energique, Inc. ALOE; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; CALCIUM SULFIDE; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA LEAF; MERCURIC CYANIDE; MYOSOTIS ARVENSIS; NASTURTIUM AQUATICUM; PARATHYROID HORMONE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; SARSAPARILLA; SCROPHULARIA NODOSA; SODIUM SULFATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 3; 4; 12; 8; 8; 4; 8; 4; 5; 3; 5; 8; 3; 3; 12; 4; 4; 6; 3; 4; 12; 12; 3; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Parathyroid Hormone [Chemical/Ingredient],Parathyroid Hormone [EPC] 44911-0103_61c6d4af-5f18-4126-81f5-6a59cb3848c6 44911-0103 HUMAN OTC DRUG Cherry Plum PRUNUS CERASIFERA, FLOS LIQUID ORAL 20141218 UNAPPROVED HOMEOPATHIC Energique, Inc. PRUNUS CERASIFERA FLOWER 30 [hp_C]/mL 44911-0109_94d72c7e-933e-452b-a6fa-4924eba0de8f 44911-0109 HUMAN OTC DRUG WINTER BLEND NOT APPLICABLE LIQUID ORAL 20141002 UNAPPROVED HOMEOPATHIC Energique, Inc. ARCTOSTAPHYLOS UVA-URSI LEAF; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; LACHESIS MUTA VENOM; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM CHLORIDE; SELENIUM; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP 1; 3; 12; 6; 12; 1; 12; 6; 6; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0110_19d8ba48-e574-418a-bb22-5da219bfc10a 44911-0110 HUMAN OTC DRUG Body Balance Avena Sativa, Chlorophytum Borivilianum, Nuphar Luteum, Punica Granatum, Spermidine, Spermine, Damiana, Selenium Metallicum, Staphysagria, Thuja Occidentalis LIQUID ORAL 20131202 UNAPPROVED HOMEOPATHIC Energique, Inc. ASPARAGUS ADSCENDENS ROOT; AVENA SATIVA FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; NUPHAR LUTEUM ROOT; POMEGRANATE; SELENIUM; SPERMIDINE; SPERMINE; THUJA OCCIDENTALIS LEAF; TURNERA DIFFUSA LEAFY TWIG 3; 3; 9; 6; 6; 9; 6; 6; 12; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0111_175aef77-002f-4b99-8d59-df1551d3f1b1 44911-0111 HUMAN OTC DRUG Allerstat II Baptisia tinctoria, Echinacea (angustifolia), Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Euphrasia officinalis, Natrum sulphuricum, LIQUID ORAL 20140317 UNAPPROVED HOMEOPATHIC Energique, Inc. AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; EUPHRASIA STRICTA; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0112_aa2bc633-758f-4eb7-ada9-6a210725e9d8 44911-0112 HUMAN OTC DRUG ALLERSTAT II NOT APPLICABLE LIQUID ORAL 20141015 UNAPPROVED HOMEOPATHIC Energique, Inc. AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; EUPHRASIA STRICTA; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0113_7f01c1cc-09a2-4745-bd83-1b5891335200 44911-0113 HUMAN OTC DRUG LYME HP NOT APPLICABLE LIQUID ORAL 20141028 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BORRELIA BURGDORFERI; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HEPATITIS B VIRUS; JAPANESE ENCEPHALITIS VIRUS; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; NEISSERIA MENINGITIDIS; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 30; 3; 12; 30; 30; 30; 3; 3; 12; 12; 30; 30; 30; 12; 30; 30 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 44911-0114_df942a2d-16a4-4dee-a082-2d77234a5f82 44911-0114 HUMAN OTC DRUG LYME HP NOT APPLICABLE LIQUID ORAL 20141020 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BORRELIA BURGDORFERI; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HEPATITIS B VIRUS; JAPANESE ENCEPHALITIS VIRUS; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; NEISSERIA MENINGITIDIS; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 30; 3; 12; 30; 30; 30; 3; 3; 12; 12; 30; 30; 30; 12; 30; 30 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 44911-0115_a73817c0-4ea2-465c-aa4e-e7e18214ac69 44911-0115 HUMAN OTC DRUG Terrestristat Alfalfa, Avena sativa, Fucus vesiculosus, Thyroidinum (suis), Agate, Cadmium iodatum, Calcarea phosphorica, Cuprum metallicum, Phosphoricum acidum, LIQUID ORAL 20140516 UNAPPROVED HOMEOPATHIC Energique, Inc. ALCOHOL, X-RAY EXPOSED (1000 RAD); ALFALFA; AVENA SATIVA FLOWERING TOP; CADMIUM IODIDE; CITHARACANTHUS SPINICRUS; COPPER; FUCUS VESICULOSUS; PHOSPHORIC ACID; PHOSPHORUS; SILICON DIOXIDE; STRONTIUM CARBONATE; SUS SCROFA THYROID; TRIBASIC CALCIUM PHOSPHATE; URANYL NITRATE HEXAHYDRATE 30; 3; 3; 12; 30; 12; 3; 12; 12; 12; 12; 6; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0116_493897dd-2151-4c5c-b06e-d4a63f83b805 44911-0116 HUMAN OTC DRUG Bactestat Baptisia tinctoria, Echinacea (angustifolia), Phytolacca decandra, Aconitum napellus, Arsenicum album, Belladonna, Ferrum phosphoricum LIQUID ORAL 20140324 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; LACHESIS MUTA VENOM; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT 12; 12; 12; 3; 3; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0117_cfd0edc1-1819-4641-8586-c8f11a4aed83 44911-0117 HUMAN OTC DRUG Virustat Echinacea (Angustifolia), Hydrastis canadensis, Lomatium dissectum, Aconitum napellus, Arsenicum album, Belladonna, Eupatorium perfoliatum, Gelsemium sempervirens, LIQUID ORAL 20140424 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; ARSENIC ACID; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; LOMATIUM DISSECTUM ROOT; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3; 12; 3; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0118_d9d1914c-ce7c-433e-9f7b-aea5a4ef5f58 44911-0118 HUMAN OTC DRUG Terrestristat Alfalfa, Avena sativa, Fucus vesiculosus, Thyroidinum (suis), Agate, Cadmium iodatum, Calcarea phosphorica, Cuprum metallicum, LIQUID ORAL 20140516 UNAPPROVED HOMEOPATHIC Energique, Inc. ALCOHOL, X-RAY EXPOSED (1000 RAD); ALFALFA; AVENA SATIVA FLOWERING TOP; CADMIUM IODIDE; CITHARACANTHUS SPINICRUS; COPPER; FUCUS VESICULOSUS; PHOSPHORIC ACID; PHOSPHORUS; SILICON DIOXIDE; STRONTIUM CARBONATE; SUS SCROFA THYROID; TRIBASIC CALCIUM PHOSPHATE; URANYL NITRATE HEXAHYDRATE 30; 3; 3; 12; 30; 12; 3; 12; 12; 12; 12; 6; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0119_55a638e0-98c8-4065-a22d-729a64abb0f9 44911-0119 HUMAN OTC DRUG Fungustat I Echinacea (Angustifolia), Tabebuia impetiginosa, Abies nigra, Lycopodium clavatum, Nux vomica, Phosphorus, Pulsatilla (Vulgaris), Sepia, Skatolum, Canadida albicans, LIQUID ORAL 20140505 UNAPPROVED HOMEOPATHIC Energique, Inc CANDIDA ALBICANS; ECHINACEA ANGUSTIFOLIA; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PICEA MARIANA RESIN; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SKATOLE; STRYCHNOS NUX-VOMICA SEED; TABEBUIA IMPETIGINOSA BARK 30; 3; 12; 12; 12; 12; 12; 15; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0120_85451ae8-c0d7-4d43-aef8-dc34930a9ad9 44911-0120 HUMAN OTC DRUG Lymphdrainex Geramium robertianum, Nasturtium aquaticum, Aloe socotrina, Myosotis arvensis, Scrophularia nodosa, Teucrium scorodonia, Apis mellifica, Equiesetum hyemale, Fumaria officinalis, Natrum sulphuricum, LIQUID ORAL 20140527 UNAPPROVED HOMEOPATHIC Energique, Inc. ALOE; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; BOS TAURUS PARATHYROID GLAND; CALCIUM SULFIDE; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MERCURIC CYANIDE; MYOSOTIS ARVENSIS; NASTURTIUM AQUATICUM; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; SCROPHULARIA NODOSA; SMILAX REGELII ROOT; SODIUM SULFATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 3; 4; 12; 8; 12; 8; 4; 8; 4; 5; 3; 5; 5; 8; 3; 3; 4; 4; 3; 6; 4; 12; 12; 3; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0121_1a8b2baf-f0a6-4d36-9c2d-b7067d826c68 44911-0121 HUMAN OTC DRUG Candida Cord Candida Albicans LIQUID ORAL 20140708 UNAPPROVED HOMEOPATHIC Energique, Inc. CANDIDA ALBICANS 12 [hp_X]/mL 44911-0122_d73175c8-fb71-45f6-b58d-490645f60c2b 44911-0122 HUMAN OTC DRUG BAC HP NOT APPLICABLE LIQUID ORAL 20140717 UNAPPROVED HOMEOPATHIC Energique, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0123_26a03484-85fe-47d6-b6ca-e864ec1b5c44 44911-0123 HUMAN OTC DRUG BAC HP APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS LIQUID ORAL 20141211 UNAPPROVED HOMEOPATHIC Energique, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0124_376042fd-89d6-48c6-8b85-69a700705722 44911-0124 HUMAN OTC DRUG Trauma plus Gel not applicable GEL TOPICAL 20140718 UNAPPROVED HOMEOPATHIC Energique, Inc. ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE; SULFURIC ACID; TOXICODENDRON PUBESCENS LEAF 1; 12; 30; 1; 3; 30; 1; 12; 30; 30; 12; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g 44911-0125_30abbee7-f9ca-4a92-b68b-ffc0311fd9d6 44911-0125 HUMAN OTC DRUG Virustat NOT APPLICABLE LIQUID ORAL 20140902 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; LOMATIUM DISSECTUM ROOT; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3; 12; 3; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0126_317b0ea8-2040-488c-8423-a393694a59f0 44911-0126 HUMAN OTC DRUG Male Balance NOT APPLICABLE LIQUID ORAL 20140915 UNAPPROVED HOMEOPATHIC Energique,Inc. (Larry Krenk) AVENA SATIVA FLOWERING TOP; CHASTE TREE; EPIMEDIUM GRANDIFLORUM TOP; GINKGO; LYCOPODIUM CLAVATUM SPORE; PORK LIVER; SEROTONIN HYDROCHLORIDE; SOMATROPIN; SPERMIDINE; SPERMINE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA TESTICLE; TESTOSTERONE; TURNERA DIFFUSA LEAFY TWIG 6; 12; 30; 12; 12; 6; 30; 26; 12; 12; 12; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44911-0127_dd554b5f-2ec8-43b7-8be9-21a68518adf3 44911-0127 HUMAN OTC DRUG TRAUMA PLUS NOT APPLICABLE GEL TOPICAL 20140926 UNAPPROVED HOMEOPATHIC Energique, Inc. ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE; SULFURIC ACID; TOXICODENDRON PUBESCENS LEAF 1; 12; 30; 1; 3; 30; 1; 12; 30; 30; 12; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g 44911-0130_28b0ffa1-f680-41f4-bd26-598cd31217aa 44911-0130 HUMAN OTC DRUG WART BARYTA CARBONICA, ANTIMONIUM CRUDUM, CAUSTICUM, DULCAMARA, NITRICUM ACIDUM, SILICEA, STAPHYSAGRIA, THUJA OCCIDENTALIS, CALCAREA CARBONICA, SEPIA GEL TOPICAL 20141203 UNAPPROVED HOMEOPATHIC Engergique, Inc. ANTIMONY TRISULFIDE; BARIUM CARBONATE; CAUSTICUM; DELPHINIUM STAPHISAGRIA SEED; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; THUJA OCCIDENTALIS LEAFY TWIG 30; 12; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 44911-0131_cce9bcc5-4187-46be-a048-35e49bf2694b 44911-0131 HUMAN OTC DRUG INFECTISTAT BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOBELIA INFLATA, LOMATIUM DISSECTUM, PHYTOLACCA DECANDRA LIQUID ORAL 20141205 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAUSTICUM; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; SODIUM SULFATE; SULFUR; SUS SCROFA LUNG; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3; 3; 12; 12; 12; 3; 12; 12; 3; 3; 12; 3; 12; 12; 30; 12; 12; 12; 6; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 44924-001_6b36211f-494a-4a51-b5c3-f520a84d54e5 44924-001 HUMAN OTC DRUG BABOR HSR Lifting Soybean CREAM TOPICAL 20080101 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. SOYBEAN .01375 mL/50mL 44924-002_b22d9544-8d39-4630-9b01-d85e84018e80 44924-002 HUMAN OTC DRUG BABOR HSR Lifting Eye Cream Soybean CREAM TOPICAL 20021210 OTC MONOGRAPH NOT FINAL part310.545 Babor Cosmetics America, Corp SOYBEAN .001375 mL/30mL 44924-003_9d837528-f605-40d8-a512-a7bca21e108b 44924-003 HUMAN OTC DRUG BABOR Baborganic Biological Enzyme Cleanser Ascorbic Acid POWDER TOPICAL 20081101 OTC MONOGRAPH NOT FINAL part310.545 Babor Cosmetics America, Corp ASCORBIC ACID .375 g/75g 44924-004_b89bdf6f-5809-41fd-a2d2-ee7ec584da37 44924-004 HUMAN OTC DRUG BABOR Baborganic Age Preventing Body Cream Panthenol CREAM TOPICAL 20081101 OTC MONOGRAPH NOT FINAL part310.545 Babor Cosmetics America, Corp PANTHENOL 1.8 mL/200mL 44924-005_d3c9ad69-7f23-4b22-9cb1-9330801d8ba8 44924-005 HUMAN OTC DRUG BABOR Baborganic Calm and Relax Panthenol CREAM TOPICAL 20081101 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. PANTHENOL .04875 mL/50mL 44924-006_ec0a27ef-af00-4665-8c6a-c1839b4ef229 44924-006 HUMAN OTC DRUG BABOR BODY LINE THERMAL Firming Body Panthenol LOTION TOPICAL 20060415 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. PANTHENOL 1.5 mL/200mL 44924-007_b10de72d-c3aa-4b1c-99f0-086b9aad033f 44924-007 HUMAN OTC DRUG BABOR CLEANSING HY-OL Soybean OIL TOPICAL 20040401 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp SOYBEAN 78.2 mL/200mL 44924-008_3dc9e210-8c14-481c-8589-cdde3b4a7f10 44924-008 HUMAN OTC DRUG BABOR Cleansing Mild Peeling Sesame Seed CREAM TOPICAL 20100203 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp SESAME SEED 3.5 mL/50mL 44924-009_0496069a-2957-40aa-aa14-1ca05a02870d 44924-009 HUMAN OTC DRUG BABOR HSR Glamour Lifting Millet Seed LIQUID TOPICAL 20091101 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. MILLET SEED .007 mL/2mL 44924-010_c66b81e8-7870-4a37-a39f-350b913fd2c6 44924-010 HUMAN OTC DRUG BABOR Baborganic Crystal Face Scrub Meadowfoam Seed Oil CREAM TOPICAL 20081101 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. MEADOWFOAM SEED OIL .5 mL/50mL 44924-011_215bbcdd-164d-4c12-a6e1-b3f88cd3d330 44924-011 HUMAN OTC DRUG BABOR Baborganic Crystal Face Scrub CP Meadowfoam Seed Oil CREAM TOPICAL 20081101 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. MEADOWFOAM SEED OIL 2 mL/200mL 44924-012_d282a4cc-1f24-4ba0-9af4-206122fb197c 44924-012 HUMAN OTC DRUG BABOR CLEANSING Rose Toning Allantoin LOTION TOPICAL 20040415 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. ALLANTOIN .4 mL/200mL 44924-013_706241a5-e07b-4920-bc19-094112e3038a 44924-013 HUMAN OTC DRUG BABOR CLEANSING Mild Cleanser Panthenol LIQUID TOPICAL 20040415 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. PANTHENOL .75 mL/200mL 44924-014_cd56d834-b654-4674-b55d-dcc3b7e85e25 44924-014 HUMAN OTC DRUG BABOR Cleansing Gel and Tonic Equisetum Arvense Top GEL TOPICAL 20060315 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. EQUISETUM ARVENSE TOP .4 mL/200mL 44924-015_1c55845c-af85-4401-bf71-27c9730c43dc 44924-015 HUMAN OTC DRUG BABOR SKINOVAGE OXYGEN Energizing CP Panthenol CREAM TOPICAL 20081015 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. PANTHENOL 1.5 mL/200mL 44924-016_9c7b2597-77f8-4732-bee6-e66ee7d710b5 44924-016 HUMAN OTC DRUG BABOR Collagen Booster Allantoin LIQUID TOPICAL 20070501 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. ALLANTOIN .004 mL/2mL 44924-017_c8d0ffc8-09f2-42c6-a01e-7405c54a7454 44924-017 HUMAN OTC DRUG BABOR Selection Ultimate Care Panthenol CREAM TOPICAL 20081115 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. PANTHENOL .4875 mL/50mL 44924-018_165ca405-0dd7-4a23-83e5-d561b86eae57 44924-018 HUMAN OTC DRUG BABOR HSR Lifting Decollete Mask Panthenol GEL TOPICAL 20091101 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. PANTHENOL 1.5 mL/100mL 44924-019_9619247b-6857-4c4a-b9cd-32fa32e14dc8 44924-019 HUMAN OTC DRUG BABOR HSR Lifting Decollete Mask CP Panthenol GEL TOPICAL 20091101 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. PANTHENOL 1.5 mL/100mL 44924-020_4f24cd6a-1990-41c9-946a-cd7e4ab66f86 44924-020 HUMAN OTC DRUG BABOR HSR Glamour Lifting CP Millet Seed LIQUID TOPICAL 20091101 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. MILLET SEED .007 mL/2mL 44924-100_a931dda5-3ffe-43ff-9b88-6dca924551ca 44924-100 HUMAN OTC DRUG Moderate Protection Sun SPF 15 Octocrylene SPRAY TOPICAL 20100301 OTC MONOGRAPH FINAL part352 Babor Cosmetics America, Corp AVOBENZONE; OCTINOXATE; OCTOCRYLENE; SULISOBENZONE 6; 15; 20; 4 mL/200mL; mL/200mL; mL/200mL; mL/200mL 44924-101_b992eb9b-f122-4228-9fff-3a17bbb1f0ca 44924-101 HUMAN OTC DRUG High Protection Sun SPF 30 Titanium Dioxide CREAM TOPICAL 20100301 OTC MONOGRAPH FINAL part352 Babor Cosmetics America, Corp. OCTINOXATE; TITANIUM DIOXIDE 15; 15.5 mL/200mL; mL/200mL 44924-102_57c1d612-0f0e-40ef-82b2-ec25dc0b2324 44924-102 HUMAN OTC DRUG High Protection Sun SPF 30 Titanium Dioxide CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Babor Cosmetics America, Corp OCTINOXATE; TITANIUM DIOXIDE 2.252; 2.327 mL/30mL; mL/30mL 44924-111_f04b4d24-f532-45de-97f1-db260d723bee 44924-111 HUMAN OTC DRUG Babor Body Line Thermal Smooth Effect Body PANTHENOL LOTION TOPICAL 20100410 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp PANTHENOL 1.8 mL/200mL 44924-112_7c576ea5-dc37-4ed2-800a-f6bc8e2888b9 44924-112 HUMAN OTC DRUG BABOR Stop Cellulite Panthenol LIQUID TOPICAL 20100410 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp PANTHENOL .075 mL/10mL 44924-113_66001c50-99e0-4221-bca2-764971a2d87d 44924-113 HUMAN OTC DRUG DR. BABOR DERMA CELLULAR Ultimate Firming Decollete Mask Glycerin GEL TOPICAL 20100410 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp GLYCERIN 5.088 mL/100mL 44924-114_8aca1862-6acf-42b2-a307-b66b757b7b05 44924-114 HUMAN OTC DRUG DR. BABOR DERMA CELLULAR Ultimate Firming Eye Panthenol GEL TOPICAL 20100410 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp PANTHENOL .01 mL/100mL 44924-115_08c13f56-3133-4d6e-b6c4-d38ee47b18f7 44924-115 HUMAN OTC DRUG DR. BABOR Ultimate Vitamin CP Panthenol LIQUID TOPICAL 20100410 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp PANTHENOL .018 mL/2mL 44924-116_593a1371-a641-4b53-b219-564bd139c5b4 44924-116 HUMAN OTC DRUG DR. BABOR DERMA CELLULAR Detoxifying Vitamin SPF 15 Octocrylene CREAM TOPICAL 20100410 OTC MONOGRAPH FINAL part352 Babor Cosmetics America, Corp AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.5; 3.75; 5 mL/50mL; mL/50mL; mL/50mL 44924-117_9d9753c2-042e-41c7-b3ab-44f53dd3efff 44924-117 HUMAN OTC DRUG DR. BABOR DERMA Cellular Detoxifying Vitamin SPF 15 CP Octocrylene CREAM TOPICAL 20100410 OTC MONOGRAPH FINAL part352 Babor Cosmetics America, Corp AVOBENZONE; OCTINOXATE; OCTOCRYLENE 6; 15; 20 mL/200mL; mL/200mL; mL/200mL 44924-118_11aa115f-9817-4d43-8ea0-c3773753b83a 44924-118 HUMAN OTC DRUG Baborganic Pure Energizing Skin Glycerin LIQUID TOPICAL 20100615 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. GLYCERIN 3.1406 mL/200mL 44924-119_e417df40-8bf6-455f-9f66-b3b598092f51 44924-119 HUMAN OTC DRUG PURE SELECT Purifying Anti-Aging Panthenol CREAM TOPICAL 20100615 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. PANTHENOL .45 mL/50mL 44924-120_b7d07d5d-1039-4414-90ec-8c257abe78c1 44924-120 HUMAN OTC DRUG PURE SELECT Purifying Anti-Aging CP Panthenol CREAM TOPICAL 20100615 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp PANTHENOL 1.8 mL/200mL 44924-121_dc351da1-6bb4-4f13-a68f-2ea52f5b94f1 44924-121 HUMAN OTC DRUG PURE SELECT Purifying Anti-Aging Allantoin LOTION TOPICAL 20100615 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp ALLANTOIN .1 mL/50mL 44924-122_ba0e2aad-f714-4417-b3c8-640cde5593e7 44924-122 HUMAN OTC DRUG Baborganic Pure Line Reducing Glycerin CREAM TOPICAL 20100609 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp GLYCERIN 4.9947 mL/50mL 44924-123_f2b0aaad-5575-47a7-a5a3-411100cc9b19 44924-123 HUMAN OTC DRUG Derma Refiner Day Skin Perfecting Set Octinoxate CREAM TOPICAL 20090615 OTC MONOGRAPH FINAL part352 Babor Cosmetics America, Corp OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 2.5; 2; 2 mL/50mL; mL/50mL; mL/50mL 44924-124_0994c211-e04e-43e5-954e-58813c4c4ab6 44924-124 HUMAN OTC DRUG 3D Lifting Glycerin LIQUID TOPICAL 20090601 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp GLYCERIN .067 mL/2mL 44924-125_b5c91dec-4508-4987-8b5f-8b03bd5fe6e9 44924-125 HUMAN OTC DRUG Skinovage Nanocell Age Protecting Glycerin CREAM TOPICAL 20090801 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. GLYCERIN 2.49 mL/50mL 44924-126_d7cbea1c-01e4-4553-8941-4be3afcec5b8 44924-126 HUMAN OTC DRUG SPA Mediterranee for hands Repair Hand Glycerin CREAM TOPICAL 20090601 UNAPPROVED DRUG OTHER Babor Cosmetics America, Corp. GLYCERIN 5.15 mL/100mL 44924-130_7559f4be-6db9-40e7-abb8-d5896e8d8052 44924-130 HUMAN OTC DRUG Dr. Babor Purity Cellular Ultimate Blemish Reducing Cream Salicylic Acid CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part333D Babor Cosmetics America, Corp. SALICYLIC ACID 1.5 g/50mL 44924-131_1e880cc0-deaf-4057-8881-c00e57538f98 44924-131 HUMAN OTC DRUG CP Dr. Babor Purity Cellular Ultimate Blemish Reducing Cream Salicylic Acid CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part333D Babor Cosmetics America, Corp. SALICYLIC ACID 1.5 g/50mL 44924-132_2b8aad8e-bdac-4ecc-bd0b-719de13b600b 44924-132 HUMAN OTC DRUG Dr. Babor Purity Cellular Ultimate Blemish Reducing Duo Salicylic Acid, Zinc Oxide KIT 20130731 OTC MONOGRAPH FINAL part333D Babor Cosmetics America, Corp. 44924-133_6480416a-612b-418d-ae96-c296e23ffbbf 44924-133 HUMAN OTC DRUG CP Dr. Babor Purity Cellular Stop Blemish Fluid Salicylic Acid LIQUID TOPICAL 20130815 OTC MONOGRAPH FINAL part333D Babor Cosmetics America, Corp. SALICYLIC ACID 2 mg/30mg 44929-001_04da03d3-1cb6-40e5-a708-ce9ce6e655ab 44929-001 HUMAN OTC DRUG Cleanize sodium chloride SOLUTION NASAL; OPHTHALMIC 20081125 OTC MONOGRAPH NOT FINAL part349 Laboratoires Gifrer Barbezat SODIUM CHLORIDE 900 mg/100mL 44929-002_7336682d-094c-4f71-9e15-6854ed73e304 44929-002 HUMAN OTC DRUG Cleanoz sodium chloride SOLUTION NASAL; OPHTHALMIC 20081125 OTC MONOGRAPH NOT FINAL part341 Laboratoires Gifrer Barbezat SODIUM CHLORIDE 900 mg/100mL 44946-1008_893a0744-7f63-455c-867a-01440c4465d5 44946-1008 HUMAN PRESCRIPTION DRUG Ludent Sodium Fluoride TABLET, CHEWABLE ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc. SODIUM FLUORIDE .25 mg/1 44946-1009_ce42fc86-92e6-4d23-85fd-065e5eda84ec 44946-1009 HUMAN PRESCRIPTION DRUG Ludent Sodium Fluoride TABLET, CHEWABLE ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE .5 mg/1 44946-1010_8ebdf5b0-8d31-4a63-8d47-561194b2bbad 44946-1010 HUMAN PRESCRIPTION DRUG Ludent Sodium Fluoride TABLET, CHEWABLE ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE 1 mg/1 44946-1012_51692a5d-5788-4de2-8752-1351eb6597b8 44946-1012 HUMAN PRESCRIPTION DRUG MVC Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-Tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid and cyanocobalamin TABLET, CHEWABLE ORAL 20091220 UNAPPROVED DRUG OTHER Sancilio & Company Inc ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A PALMITATE 15; 60; 400; 4.5; .3; 13.5; 1.05; 1.2; .25; 1.05; 2500 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 44946-1013_51692a5d-5788-4de2-8752-1351eb6597b8 44946-1013 HUMAN PRESCRIPTION DRUG MVC Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-Tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid and cyanocobalamin TABLET, CHEWABLE ORAL 20091220 UNAPPROVED DRUG OTHER Sancilio & Company Inc ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A PALMITATE 15; 60; 400; 4.5; .3; 13.5; 1.05; 1.2; .5; 1.05; 2500 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 44946-1014_51692a5d-5788-4de2-8752-1351eb6597b8 44946-1014 HUMAN PRESCRIPTION DRUG MVC Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-Tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid and cyanocobalamin TABLET, CHEWABLE ORAL 20091220 UNAPPROVED DRUG OTHER Sancilio & Company Inc ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A PALMITATE 15; 60; 400; 4.5; .3; 13.5; 1.05; 1.2; 1; 1.05; 2500 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 44946-1015_3424acc5-d8d6-4d35-b83e-f89323bbc289 44946-1015 HUMAN PRESCRIPTION DRUG Ludent Sodium Fluoride TABLET, CHEWABLE ORAL 20090910 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE .25 mg/1 44946-1016_3424acc5-d8d6-4d35-b83e-f89323bbc289 44946-1016 HUMAN PRESCRIPTION DRUG Ludent Sodium Fluoride TABLET, CHEWABLE ORAL 20090910 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE .5 mg/1 44946-1017_3424acc5-d8d6-4d35-b83e-f89323bbc289 44946-1017 HUMAN PRESCRIPTION DRUG Ludent Sodium Fluoride TABLET, CHEWABLE ORAL 20090910 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE 1 mg/1 44946-1020_d1a68885-5282-47e4-9301-327ed9980c09 44946-1020 HUMAN PRESCRIPTION DRUG MVC-Fluoride Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-Tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, and Cyanocobalamin TABLET, CHEWABLE ORAL 20111207 UNAPPROVED DRUG OTHER Sancilio & Company Inc. ALPHA-TOCOPHEROL; ASCORBIC ACID; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE; VITAMIN A; VITAMIN D 15; 60; 4.5; .3; 13.5; 1.05; 1.2; .25; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 44946-1021_e8e8f521-0ecb-4046-b1b7-c629d4b71ea3 44946-1021 HUMAN PRESCRIPTION DRUG MVC-Fluoride Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-Tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, and Cyanocobalamin TABLET, CHEWABLE ORAL 20111207 UNAPPROVED DRUG OTHER Sancilio & Company Inc. ALPHA-TOCOPHEROL; ASCORBIC ACID; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE; VITAMIN A; VITAMIN D 15; 60; 4.5; .3; 13.5; 1.05; 1.2; .5; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 44946-1022_4e31a281-2562-44d0-bac5-c52d43823ff0 44946-1022 HUMAN PRESCRIPTION DRUG MVC-Fluoride Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-Tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, and Cyanocobalamin TABLET, CHEWABLE ORAL 20111207 UNAPPROVED DRUG OTHER Sancilio & Company Inc ALPHA-TOCOPHEROL; ASCORBIC ACID; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE; VITAMIN A; VITAMIN D 15; 60; 4.5; .3; 13.5; 1.05; 1.2; 1; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 44946-1023_e93d9c81-44f0-4cdb-9abc-4b0bff4dd302 44946-1023 HUMAN PRESCRIPTION DRUG Multivitamin with fluoride .Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, and Vitamin D TABLET, CHEWABLE ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE; VITAMIN A; VITAMIN D 15; 60; 4.5; .3; 13.5; 1.05; 1.2; .25; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC] 44946-1024_3faa9aba-bed8-4864-b34c-fd1f1d0e5ed7 44946-1024 HUMAN PRESCRIPTION DRUG Multivitamin with fluoride .Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, and Vitamin D TABLET, CHEWABLE ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE; VITAMIN A; VITAMIN D 15; 60; 4.5; .3; 13.5; 1.05; 1.2; .5; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC] 44946-1025_141169f1-76fb-4b68-8400-28d80f824023 44946-1025 HUMAN PRESCRIPTION DRUG Multivitamin with fluoride .Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, and Vitamin D TABLET, CHEWABLE ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE; VITAMIN A; VITAMIN D 15; 60; 4.5; .3; 13.5; 1.05; 1.2; 1; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC] 44946-1032_bc1b867f-f5c5-47c7-aa66-204a6008ba34 44946-1032 HUMAN PRESCRIPTION DRUG Sodium Fluoride Sodium Fluoride SOLUTION/ DROPS ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE .5 mg/mL 44946-1035_c405e606-1a91-4e80-bcda-20c6c3d871e0 44946-1035 HUMAN PRESCRIPTION DRUG Tri-Vitamin with Fluoride Vitamin A, Ascorbic Acid, Vitamin D, and Sodium Fluoride SOLUTION/ DROPS ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc ASCORBIC ACID; SODIUM FLUORIDE; VITAMIN A; VITAMIN D 35; .25; 1500; 400 mg/mL; mg/mL; [iU]/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC] 44946-1036_8c88074b-a6ce-4670-ac35-391f364c807f 44946-1036 HUMAN PRESCRIPTION DRUG Tri-Vitamin with Fluoride Vitamin A, Ascorbic Acid, Vitamin D, and Sodium Fluoride SOLUTION/ DROPS ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc ASCORBIC ACID; SODIUM FLUORIDE; VITAMIN A; VITAMIN D 35; .5; 1500; 400 mg/mL; mg/mL; [iU]/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC] 44946-1041_c5edbc03-95cb-4268-a3a3-d950a314ea60 44946-1041 HUMAN PRESCRIPTION DRUG PNV Prenatal Vitamin .Alpha.-Tocopherol Acetate, DL-, Cholecalciferol, Cyanocobalamin, Ferrous fumarate, Folic Acid, Niacinamide, Sodium Ascorbate, Ascorbic Acid, Pyridoxine Hydrochloride, Riboflavin, and Thiamine Mononitrate TABLET, CHEWABLE ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE 11; 60; 400; 12; 29; 1; 20; 10; 3; 60; 2 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 44946-1045_d5d18073-98ba-48e5-bd7c-ad8afe16ab64 44946-1045 HUMAN PRESCRIPTION DRUG PNV Prenatal Plus Multivitamin VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, and CUPRIC OXIDE TABLET ORAL 20130401 UNAPPROVED DRUG OTHER Sancilio & Company Inc .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE 22; 2000; 120; 200; 400; 2; 12; 27; 1; 20; 10; 3; 1.84; 2000; 25 mg/1; [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 44946-1046_f3af7e93-287a-4e40-9934-daf64e15efde 44946-1046 HUMAN PRESCRIPTION DRUG PNV Prenatal Vitamin Plus Vitamin A .Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Folic Acid, Ferrous fumarate, Calcium Phosphate, Dibasic, Anhydrous, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate, and Vitamin A Acetate TABLET ORAL 20121207 UNAPPROVED DRUG OTHER Sancilio & Company Inc .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; CHOLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE 15; 60; 50; 400; 4.5; 27; 1; 13.5; 1.05; 1.2; 1.05; 2500 [iU]/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC] 44946-1050_821e0038-5a99-4f53-a627-bec0bc200598 44946-1050 HUMAN PRESCRIPTION DRUG Neutral Sodium Fluoride Sodium Fluoride RINSE ORAL 20130101 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE 20 mg/mL 45014-130_c96c5d9b-5566-4135-9438-0032c4e9b5a0 45014-130 HUMAN OTC DRUG Acetaminophen Acetaminophen LIQUID ORAL 20111001 OTC MONOGRAPH FINAL part343 Accudial Pharmaceutical, Inc. ACETAMINOPHEN 160 mg/5mL 45014-131_c9eb1f5c-6b5a-4ba5-932f-412a2fa463a1 45014-131 HUMAN OTC DRUG Pain and Fever Acetaminophen SUSPENSION ORAL 20100104 OTC MONOGRAPH FINAL part343 Accudial Pharmaceutical, Inc. ACETAMINOPHEN 160 mg/5mL 45014-136_33988a22-7905-4454-a0ee-6e402fd9ba5e 45014-136 HUMAN OTC DRUG Childrens Accudial Pain reliever/ Fever reducer Acetaminophen SUSPENSION ORAL 20120425 OTC MONOGRAPH FINAL part343 Accudial Pharmaceutical, Inc. ACETAMINOPHEN 160 mg/5mL 45014-137_3614e44e-8510-4fd2-9762-741b9659323d 45014-137 HUMAN OTC DRUG Childrens ACCUDIAL Pain reliever/ Fever reducer Acetaminophen SUSPENSION ORAL 20120425 OTC MONOGRAPH FINAL part343 Accudial Pharmaceutical, Inc. ACETAMINOPHEN 160 mg/5mL 45014-138_12ffc15e-707e-4f2d-8be8-731ded3db3aa 45014-138 HUMAN OTC DRUG Childrens ACCUDIAL Pain reliever/ Fever reducer Acetaminophen SUSPENSION ORAL 20120425 OTC MONOGRAPH FINAL part343 Accudial Pharmaceutical, Inc. ACETAMINOPHEN 160 mg/5mL 45014-139_e3231b59-92e6-4c68-9e50-e469fc2c2958 45014-139 HUMAN OTC DRUG Childrens ACCUDIAL Pain reliever/ Fever reducer Acetaminophen SUSPENSION ORAL 20120425 OTC MONOGRAPH FINAL part343 Accudial Pharmaceutical, Inc. ACETAMINOPHEN 160 mg/5mL 45014-140_ad761594-3a4d-403b-9f45-6cdbf365d0ab 45014-140 HUMAN OTC DRUG Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20091026 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 45014-141_bd6d673a-27d7-4fa7-9d0f-62a89882ea6e 45014-141 HUMAN OTC DRUG Allergy and Stuffy Nose Chlorpheniramine Maleate and Phenylephrine Hydrochloride LIQUID ORAL 20091111 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 45014-150_f0ffa4f3-7a9c-44ed-a4c1-cba9af870345 45014-150 HUMAN OTC DRUG Chest Congestion Guaifenesin LIQUID ORAL 20091026 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. GUAIFENESIN 100 mg/5mL 45014-151_3c3797ea-03dd-41d3-8f2d-bcd80ee1c040 45014-151 HUMAN OTC DRUG Cough and Cold Chlorpheniramine Maleate and Dextromethorphan Hydrobromide LIQUID ORAL 20091125 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 1; 7.5 mg/5mL; mg/5mL 45014-152_0fc0b6aa-ff81-4bff-b9d5-e10634b3c244 45014-152 HUMAN OTC DRUG Daytime Cough And Cold Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20091026 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 1.25 mg/5mL; mg/5mL 45014-153_fa42da7d-006e-41a9-9885-5cb317e86020 45014-153 HUMAN OTC DRUG Runny Nose and Cough Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20091104 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE .5; 5; 1.25 mg/5mL; mg/5mL; mg/5mL 45014-154_2d46d37d-abad-4b65-a19c-69d843ea6662 45014-154 HUMAN OTC DRUG Nite Time Cold and Cough Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride LIQUID ORAL 20091125 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 45014-158_97558c3c-84f5-4185-8462-a113bd2e3be8 45014-158 HUMAN OTC DRUG Daytime Cough and Cold Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride SOLUTION ORAL 20130201 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 45014-159_9eaf18d1-da77-46e4-9730-3671f8529fb6 45014-159 HUMAN OTC DRUG Nite Time Cold and Cough Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride SOLUTION ORAL 20130201 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 45014-161_f8c91261-b067-4bea-810b-6b28dc893b0e 45014-161 HUMAN OTC DRUG Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20130201 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 45014-163_c7ba2caf-ed17-4171-b900-4d3e0155cdc4 45014-163 HUMAN OTC DRUG Chest Congestion Guaifenesin SOLUTION ORAL 20130201 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. GUAIFENESIN 100 mg/5mL 45028-001_70658ea4-f35a-47e5-9d3e-817654b72d4a 45028-001 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 20101130 UNAPPROVED MEDICAL GAS North Central Medical Supply, Inc. OXYGEN 992 mL/L 45043-558_c6822ce4-e741-4366-b72a-5f5146354f97 45043-558 HUMAN PRESCRIPTION DRUG Vecamyl Mecamylamine Hydrochloride TABLET ORAL 20130319 ANDA ANDA204054 Manchester Pharmaceuticals MECAMYLAMINE HYDROCHLORIDE 2.5 mg/1 Autonomic Ganglionic Blocker [EPC],Decreased Autonomic Ganglionic Activity [PE] 45043-876_d6369783-3cd7-4d99-8ddd-07102a5512f9 45043-876 HUMAN PRESCRIPTION DRUG Chenodal Chenodiol TABLET, FILM COATED ORAL 20091001 ANDA ANDA091019 Manchester Pharmaceuticals Inc. CHENODIOL 250 mg/1 45046-0001_4917b7c0-8e44-4ba8-89a2-e244e6b65ac1 45046-0001 HUMAN OTC DRUG Ultimate High IGF 1 IGF 2 Arnica Montana, Deer Antler Velvet, Hepar Bovinum, HGH, HGH, IGF 1, Pituitary Bovinum, Pituitary Bovinum LIQUID ORAL 20130325 UNAPPROVED HOMEOPATHIC NewTropin, Inc. ARNICA MONTANA; BEEF LIVER; BOS TAURUS PITUITARY GLAND; CERVUS ELAPHUS VELVET; MECASERMIN; SOMATROPIN; THUJA OCCIDENTALIS LEAF 6; 6; 5; 8; 8; 24; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 45124-001_7f7ff9c6-8f65-45fd-9a30-35fcee39d2fd 45124-001 HUMAN OTC DRUG Oscar de la Renta Moisturizing Sunscreen SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20120411 OTC MONOGRAPH FINAL part352 Oscar de la Renta LLC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 6 mL/100mL; mL/100mL; mL/100mL 45146-110_b45bc681-fe7f-42d5-b84b-bcf1da1a7ad9 45146-110 HUMAN PRESCRIPTION DRUG Orabloc articaine hydrochloride and epinephrine bitartrate INJECTION SUBMUCOSAL 20110301 NDA NDA022466 Pierrel S.p.A. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; 10 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 45146-120_b45bc681-fe7f-42d5-b84b-bcf1da1a7ad9 45146-120 HUMAN PRESCRIPTION DRUG Orabloc articaine hydrochloride and epinephrine bitartrate INJECTION SUBMUCOSAL 20110301 NDA NDA022466 Pierrel S.p.A. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 45149-014_dfb48047-6239-d5dc-a113-2bf57984195c 45149-014 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19650101 NDA NDA205815 Linde Merchant Production Inc. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 45156-2250_e620a5fb-14fb-48b6-8e98-abeb9c19f21d 45156-2250 HUMAN OTC DRUG Flower O Life Pain Relieving Balm Camphor, Menthol, Wintergreen Oil OIL TOPICAL 20110808 OTC MONOGRAPH FINAL part348 Skin Deep CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 6; 15; 30 g/100g; g/100g; g/100g 45156-5502_0f21ff3e-6619-41ee-bde7-473b91cb55e4 45156-5502 HUMAN OTC DRUG Inflammation OTC Bruise Relief Camphor LOTION TOPICAL 20110808 OTC MONOGRAPH FINAL part348 Skin Deep CAMPHOR (NATURAL) 32 g/1000g 45156-5605_c241ecee-ca1a-4186-88d7-f6665fea3dcf 45156-5605 HUMAN OTC DRUG Inflammation OTC Deep Pain Care Hot Camphor, Capsicum, Menthol LOTION TOPICAL 20110816 OTC MONOGRAPH FINAL part348 Skin Deep CAMPHOR (NATURAL); CAPSICUM; MENTHOL 4; 38; 17 g/1000g; g/1000g; g/1000g 45156-5610_a1c737d4-eec3-4bda-b406-54aab5b66e3f 45156-5610 HUMAN OTC DRUG Inflammation OTC Deep Pain Care Cold Camphor, Menthol LOTION TOPICAL 20110816 OTC MONOGRAPH FINAL part348 Skin Deep CAMPHOR (NATURAL); MENTHOL 18; 16 g/600g; g/600g 45156-5616_2b840267-8a9f-4168-a63f-0b1d67647932 45156-5616 HUMAN OTC DRUG Inflammation OTC Radiation Relief Allantoin LOTION TOPICAL 20100613 OTC MONOGRAPH FINAL part347 Skin Deep ALLANTOIN 3 g/600g 45163-451_41da3fff-f7b1-42d3-94c0-a21687449983 45163-451 HUMAN OTC DRUG NANO SILVER TOOTHPASTE SODIUM MONOFLUOROPHOSPHATE, SILICON DIOXIDE, GLYCERIN PASTE ORAL 20100120 OTC MONOGRAPH FINAL part355 Nanowell Korea Inc GLYCERIN; SILICON DIOXIDE; SODIUM MONOFLUOROPHOSPHATE 5; 14; 1.4 g/200g; g/200g; g/200g 45167-030_e366ebbe-95bc-4027-a23e-70f15ec696de 45167-030 HUMAN OTC DRUG NWC21 NATURAL SUN PROTECTOR SPF35 TITANIUM DIOXIDE CREAM CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 CLEANSIA CORPORATION LTD. TITANIUM DIOXIDE 1.18 mL/60mL 45167-040_4b308335-55a5-486f-ae21-9e598a284275 45167-040 HUMAN OTC DRUG NWC21 NATURAL SUN PROTECTOR SPF50 TITANIUM DIOXIDE CREAM CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 CLEANSIA CORPORATION LTD. TITANIUM DIOXIDE 2.1 mL/60mL 45167-167_2fc4d5d7-bf45-4b1d-893b-12d05f919527 45167-167 HUMAN OTC DRUG NWC21 NATURAL WHITE CREAM TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20100121 OTC MONOGRAPH FINAL part352 Cleansia Co Ltd TITANIUM DIOXIDE; ZINC OXIDE 2; .8 g/200g; g/200g 45167-451_1e6f4afe-fffe-4088-bcb0-7426d6281984 45167-451 HUMAN OTC DRUG NWC 21 NATURAL PREMIUM BB CREAM OCTINOXATE, TITANIUM DIOXIDE, ENZACAMENE CREAM TOPICAL 20100121 OTC MONOGRAPH FINAL part352 Cleansia Co Ltd ENZACAMENE; OCTINOXATE; TITANIUM DIOXIDE 1; 3.75; 1.1 g/50g; g/50g; g/50g 45167-516_b5ab35c8-9590-4ff4-9c71-3d19867ec713 45167-516 HUMAN OTC DRUG QT SUN BLOCK OCTINOXATE, TITANIUM DIOXIDE, ENZACAMENE CREAM TOPICAL 20100121 OTC MONOGRAPH FINAL part352 Cleansia Co Ltd ENZACAMENE; OCTINOXATE; TITANIUM DIOXIDE 2; 7.5; 2.2 g/100g; g/100g; g/100g 45264-001_5729a3b0-f19a-4fa5-9445-ba20a8d56e1e 45264-001 HUMAN OTC DRUG Protective and Moisturizing Skin Clotrimazole OIL TOPICAL 20081204 OTC MONOGRAPH FINAL part333C Eduard Gerlach GmbH CLOTRIMAZOLE 10 mg/mL 45264-002_d44061a0-5a7c-4b59-80ef-e4db07670da0 45264-002 HUMAN OTC DRUG Protective Nail and skin Clotrimazole CREAM TOPICAL 20081204 OTC MONOGRAPH FINAL part333C Eduard Gerlach GmbH CLOTRIMAZOLE 10 mg/mL 45264-003_e2a32b69-af3d-4ccd-b15e-b7b28b234bb4 45264-003 HUMAN OTC DRUG Gehwol med Foot Clotrimazole POWDER TOPICAL 20081204 OTC MONOGRAPH FINAL part333C Eduard Gerlach GmbH CLOTRIMAZOLE 1 g/100g 45264-004_008b0497-91c3-421e-8761-41534fa8819b 45264-004 HUMAN OTC DRUG Gerlasan Hand Clotrimazole CREAM TOPICAL 20081204 OTC MONOGRAPH FINAL part333C Eduard Gerlach GmbH CLOTRIMAZOLE 6 mg/mL 45264-005_52eb400f-faa7-4e13-b6e7-c14acf613bc4 45264-005 HUMAN OTC DRUG Gehwol Foot and Shoe Deodorant Triclosan AEROSOL TOPICAL 20050401 OTC MONOGRAPH NOT FINAL part333A Eduard Gerlach GmbH TRICLOSAN 3 mg/mL 45264-006_b66d5f86-1e9e-45ff-9930-a73a2d8410be 45264-006 HUMAN OTC DRUG Gehwol med Callus Urea CREAM TOPICAL 20100708 UNAPPROVED DRUG OTHER Eduard Gerlach GmbH UREA 180 mg/mL 45264-007_6e831237-e825-4ca9-88dc-01949ca6c9af 45264-007 HUMAN OTC DRUG Gehwol med Lipidro Urea CREAM TOPICAL 20050625 UNAPPROVED DRUG OTHER Eduard Gerlach GmbH UREA 100 mg/mL 45264-008_df1175ef-6692-4c0c-9642-278c2e42de49 45264-008 HUMAN OTC DRUG Gehwol Fusskraft Nail and Skin Protection Clotrimazole SPRAY TOPICAL 20090618 OTC MONOGRAPH FINAL part333C Eduard Gerlach GmbH CLOTRIMAZOLE 4 mg/mL 45264-009_f48c9a18-03b7-4183-a764-95daed36b4e2 45264-009 HUMAN OTC DRUG Gehwol Nail Protection Pen Clotrimazole LIQUID TOPICAL 20080307 OTC MONOGRAPH NOT FINAL part333C Eduard Gerlach GmbH CLOTRIMAZOLE 10 mg/mL 45264-010_47f911ea-2fd5-4b39-96c7-66fd9218f3a2 45264-010 HUMAN OTC DRUG Gehwol FUSSKRAFT Callus Softener Urea LIQUID TOPICAL 20080324 UNAPPROVED DRUG OTHER Eduard Gerlach GmbH UREA 250 mg/mL 45334-353_e2128c73-f6b0-4b13-b91d-e070af627256 45334-353 HUMAN OTC DRUG VANICREAM Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 Pharmaceutical Specialties, Inc. TITANIUM DIOXIDE; ZINC OXIDE .034; .06 g/g; g/g 45334-355_454f3ccf-e6d5-4330-98a3-3c411d6065b2 45334-355 HUMAN OTC DRUG VANICREAM Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 Pharmaceutical Specialties, Inc. TITANIUM DIOXIDE; ZINC OXIDE .03; .11 g/g; g/g 45334-356_f7a7db34-daa7-497b-be18-4c253b4f7233 45334-356 HUMAN OTC DRUG VANICREAM Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 Pharmaceutical Specialties, Inc. TITANIUM DIOXIDE; ZINC OXIDE .05; .07 g/g; g/g 45334-600_5abb70b8-7c34-4a1b-ad7e-eec0c41628e8 45334-600 HUMAN OTC DRUG Vaniply dimethicone OINTMENT TOPICAL 20110224 OTC MONOGRAPH NOT FINAL part347 Pharmaceutical Specialties, Inc. DIMETHICONE 10 mg/g 45341-0001_15225540-4aa7-4a6a-b4a5-1c81221b01f1 45341-0001 HUMAN OTC DRUG Artalgia Carduus Marianus, Arnica Montana, Agaricus Muscarius, Baryta Carbonica, Bellis Perennis, Glonoinum, Hamamelis Virginiana LIQUID ORAL 20120928 UNAPPROVED HOMEOPATHIC Todd Horton DPM ACTIVATED CHARCOAL; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARNICA MONTANA; BARIUM CARBONATE; BELLIS PERENNIS; CLAVICEPS PURPUREA SCLEROTIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEAD; MERCURIUS SOLUBILIS; NITROGLYCERIN; PHOSPHORUS; PULSATILLA VULGARIS; SILYBUM MARIANUM SEED OIL; TOXICODENDRON PUBESCENS LEAF; VANADIUM 30; 12; 3; 12; 12; 12; 12; 30; 12; 12; 12; 30; 30; 3; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 45343-0001_f2b69adb-510f-4f8c-a7a4-89cca41b2377 45343-0001 HUMAN OTC DRUG Recapture HGH Phosphoricum Acidum, Heparus Suis, HGH, IGF-1, Pituitarum (suis) SPRAY ORAL 20120629 UNAPPROVED HOMEOPATHIC DefyAging.com Inc. MECASERMIN; PHOSPHORIC ACID; PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 30; 3; 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 45405-001_ae048d49-240e-4eeb-87b2-b4a130a36f9c 45405-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19730101 UNAPPROVED MEDICAL GAS Gas Innovations LLC OXYGEN 99 L/100L 45405-002_9a90d2fe-dd4e-40be-a5c0-70490829cbf6 45405-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19720101 UNAPPROVED MEDICAL GAS Gas Innovations LLC NITROGEN 99 L/100L 45548-141_5a770925-d125-4554-b0f5-8d3361a23431 45548-141 HUMAN PRESCRIPTION DRUG KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI technetium tc 99m sestamibi INJECTION INTRAVENOUS 20090701 ANDA ANDA078806 DRAXIMAGE LLC TECHNETIUM TC-99M SESTAMIBI 1 mg/10mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 45567-0030_1bd9f4d5-3612-4961-a249-45c58f91ff87 45567-0030 HUMAN PRESCRIPTION DRUG Kit for the Prepartion of Technetium Tc99m Sulfur Colloid Technetium Tc 99m Sulfur Colloid KIT 19780419 NDA NDA017858 Pharmalucence Inc. 45567-0040_44b84192-4069-4300-9c17-54e31e949304 45567-0040 HUMAN PRESCRIPTION DRUG KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE TC 99M MEDRONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19790829 NDA NDA018124 Pharmalucence, Inc. TECHNETIUM TC-99M MEDRONATE 20 mg/10mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 45567-0060_1b9af9db-ca38-437b-882b-57edf84b5bbc 45567-0060 HUMAN PRESCRIPTION DRUG Kit for the Preparation of Technetium Tc99m Pyrophosphate Technetium Tc99m Pyrophosphate INJECTION INTRAVENOUS 19870630 NDA NDA019039 Pharmalucence, Inc. TECHNETIUM TC-99M PYROPHOSPHATE 12 mg/10mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 45567-0455_f3c57604-aecd-449c-a0e5-4d84f4dcc263 45567-0455 HUMAN PRESCRIPTION DRUG Kit for the Preparation of Technetium Tc 99m Mebrofenin Kit for the Preparation of Technetium Tc 99m Mebrofenin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080129 NDA NDA078242 Pharmalucence, Inc. MEBROFENIN 45 mg/10mL 45567-0475_04faa84e-a179-4f66-9a4a-8f6e8252ba11 45567-0475 HUMAN PRESCRIPTION DRUG Kit for the Preparation of Technetium Tc99m Disofenin HEPATOLITE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19820316 NDA NDA018467 Pharmalucence, Inc. TECHNETIUM TC-99M DISOFENIN 20 mg/10mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 45567-0555_d8b95e40-295e-4be5-a6b4-540dd243d843 45567-0555 HUMAN PRESCRIPTION DRUG Kit for the Preparation of Technetium Tc99m Sestamibi TECHNETIUM TC-99M SESTAMIBI INJECTION INTRAVENOUS 20090710 ANDA ANDA079157 Pharmalucence, Inc. TECHNETIUM TC-99M SESTAMIBI 1 mg/10mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 45634-121_a51b04fa-87a1-4b0e-b383-8c9c0c30895e 45634-121 HUMAN OTC DRUG Perricone No foundation foundation Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20120411 OTC MONOGRAPH NOT FINAL part352 NV Perricone LLC TITANIUM DIOXIDE; ZINC OXIDE 3.2; 12.2 mL/100mL; mL/100mL 45725-001_e120445c-d52a-4fd5-bf88-b75f34aad1ec 45725-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20070101 UNAPPROVED MEDICAL GAS Advanced Apothecaries Inc. dba Health Depot OXYGEN 99 L/100L 45737-203_f94b4022-2a3a-4cf6-95af-9c2ded70ad6f 45737-203 HUMAN OTC DRUG BIO Dtuss DMX Brompheniramine Maleate, Dextromethorphan, Pseudoephedrine LIQUID ORAL 20111201 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 20; 30 mg/5mL; mg/5mL; mg/5mL 45737-205_e0a64ad6-3457-491e-ba31-c2cad4dd634e 45737-205 HUMAN OTC DRUG BioGtuss Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 300; 15 mg/5mL; mg/5mL; mg/5mL 45737-206_432ffab3-9f96-4d68-8935-a2288e92bc65 45737-206 HUMAN OTC DRUG Bionel Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 15; 200; 30 mg/5mL; mg/5mL; mg/5mL 45737-207_76748794-8d3f-48f3-b9b6-33309ff3d3f3 45737-207 HUMAN OTC DRUG Bionel Pediatric Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 50; 15 mg/5mL; mg/5mL; mg/5mL 45737-208_db9e055a-714f-49b3-9701-e0a87c8ca09d 45737-208 HUMAN OTC DRUG Biocotron-D Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl SUSPENSION/ DROPS ORAL 20130301 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL 45737-209_528a64b3-97e9-44ce-a145-45e236c22c25 45737-209 HUMAN PRESCRIPTION DRUG Biocotron - Dextromethorphan, Guaifenesin LIQUID ORAL 20090101 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] 45737-210_3bf9cec4-9e30-44d2-b0d3-373167dbaddd 45737-210 HUMAN OTC DRUG Bionatuss DXP Dexbrompheniramine Maleate, Dextromethorphan, Phenylephrine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 20; 10 mg/5mL; mg/5mL; mg/5mL 45737-211_50874915-9770-492e-b883-56e72c6fe1b4 45737-211 HUMAN OTC DRUG Biospec DMX Dextromethorphan, Guaifenesin LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 15; 25 mg/5mL; mg/5mL 45737-217_06e03308-11e6-4477-8b8e-22d9c68f43dd 45737-217 HUMAN OTC DRUG Biobron SF Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 350; 10 mg/5mL; mg/5mL; mg/5mL 45737-218_cf40143f-720f-4edf-ab01-6a6f22c95255 45737-218 HUMAN OTC DRUG Bio-B Kids Dextromethorphan,Chlorpheniramine Maleate, Phenylephrine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 15; 10 mg/5mL; mg/5mL; mg/5mL 45737-221_13b19375-4fe2-40ad-8ff1-efbc6684588d 45737-221 HUMAN OTC DRUG Biodesp DM Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20090101 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 100; 5 mg/5mL; mg/5mL; mg/5mL 45737-225_a61ed81b-7422-43d6-8b84-c69810093637 45737-225 HUMAN OTC DRUG BioTPres Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 200; 5 mg/5mL; mg/5mL; mg/5mL 45737-226_f84c77b1-d231-425c-9bc7-b88424c9129c 45737-226 HUMAN OTC DRUG Bio T Pres-B BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20121101 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 20; 10 mg/5mL; mg/5mL; mg/5mL 45737-227_2cd2b7f9-9a3d-4b30-b4a4-99f21e7c85a4 45737-227 HUMAN OTC DRUG BioTPres Pediatric Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 75; 2.5 mg/5mL; mg/5mL; mg/5mL 45737-230_744a2e7b-46c7-4457-b4b3-edbca3bd62e2 45737-230 HUMAN OTC DRUG Bio-S-Pres DX Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl SOLUTION/ DROPS ORAL 20130301 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 50; 2.5 mg/mL; mg/mL; mg/mL 45737-242_a4ae9d65-88c6-4ad7-be39-e48d38128302 45737-242 HUMAN OTC DRUG BioGtuss NF Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20100901 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 28; 388; 10 mg/5mL; mg/5mL; mg/5mL 45737-246_769465ec-c7b0-46f0-ac07-a82b9f059058 45737-246 HUMAN OTC DRUG Biobron DX Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/5mL; mg/5mL; mg/5mL 45737-249_46a2a052-0660-4cd8-a581-347eb2038b03 45737-249 HUMAN OTC DRUG Biocof Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HCL LIQUID ORAL 20120701 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/5mL; mg/5mL; mg/5mL 45737-250_e4e3c3eb-6ea0-4d20-b99e-af7af4cfd144 45737-250 HUMAN OTC DRUG BIO-RYTUSS CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20120801 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/5mL; mg/5mL; mg/5mL 45737-251_58efaddb-718a-4ddf-b8aa-76ce8e5eb009 45737-251 HUMAN OTC DRUG Bio-Z-Cough Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20120701 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/5mL; mg/5mL 45737-605_678a8e9a-7480-4fbe-ad80-4907383b59c8 45737-605 HUMAN OTC DRUG Biogtuss TR Guaifenesin, Phenylephrine HCl, Dextromethorphan HBr TABLET ORAL 20140401 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 28; 388; 10 mg/1; mg/1; mg/1 45737-606_935db096-3fe5-44ca-b041-210d4ecfb96a 45737-606 HUMAN OTC DRUG Biophex TR Guaifenesin, Phenylephrine HCl TABLET ORAL 20140401 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 388; 10 mg/1; mg/1 45765-5100_fba075ec-06b1-4709-8e31-95bed7970c45 45765-5100 HUMAN OTC DRUG Baby Magic Medicated Patty Cake Zinc Oxide CREAM TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part347 Naterra International INC. ZINC OXIDE 2.75 g/11g 45765-5130_95dba6f2-e2e4-4109-8146-1bf624d67d0f 45765-5130 HUMAN OTC DRUG Baby Magic Diaper Rx Zinc Oxide CREAM TOPICAL 20100430 OTC MONOGRAPH NOT FINAL part347 Naterra International INC. ZINC OXIDE 23.8 g/85g 45765-5135_c2d311fd-e00b-4d97-be51-60b34eebb2bd 45765-5135 HUMAN OTC DRUG Fresh Baby Scent Soothing Jelly Petroleum GEL TOPICAL 20090112 OTC MONOGRAPH NOT FINAL part347 Naterra International INC. PETROLATUM 70.9787 g/71g 45765-5142_7eb7f345-33c5-41d7-bc5d-c3d2e8b3ce77 45765-5142 HUMAN OTC DRUG Gentle Eczema Balm Colloid Oatmeal STICK TOPICAL 20101012 OTC MONOGRAPH NOT FINAL part347 Naterra International INC. OATMEAL .112 g/14g 45782-0000_e6f70dd6-68ce-41a6-854b-3c925090e63d 45782-0000 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20060101 UNAPPROVED MEDICAL GAS Mountain Valley Home Medical Equipment, Inc OXYGEN 99 L/100L 45802-001_0a6bfcea-7deb-4ab2-bb6f-abe21abfa1c1 45802-001 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20140409 ANDA ANDA078326 Perrigo New York Inc NICOTINE 4 mg/1 45802-004_42357823-b7d7-4d21-8e92-fea6b74ae6e7 45802-004 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20060331 ANDA ANDA085025 Perrigo New York Inc HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-008_c9d6a486-32f8-4fc7-bbea-29b68ba8133d 45802-008 HUMAN OTC DRUG loratadine d 24 hour Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20140425 ANDA ANDA075706 Perrigo New York Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 45802-014_42357823-b7d7-4d21-8e92-fea6b74ae6e7 45802-014 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 20060613 ANDA ANDA085027 Perrigo New York Inc HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-021_0e059e98-cddf-4c2f-abaa-c9bc86863745 45802-021 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate LOTION TOPICAL 20060630 ANDA ANDA072538 Perrigo New York Inc BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-026_853ccd51-1231-4eba-898f-811897210f0f 45802-026 HUMAN PRESCRIPTION DRUG azelastine hcl nasal Azelastine HCl SPRAY NASAL 20140509 ANDA ANDA202743 Perrigo New York Inc AZELASTINE HYDROCHLORIDE 205.5 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 45802-032_d277ed85-8ee7-46e2-a575-5b363d3d9185 45802-032 HUMAN OTC DRUG Tolnaftate Tolnaftate CREAM TOPICAL 20110802 OTC MONOGRAPH FINAL part333C Perrigo New York Inc TOLNAFTATE 1 g/100g 45802-033_fd7b68d3-2f0f-43a1-83eb-66fe14208343 45802-033 HUMAN OTC DRUG antifungal Tolnaftate SOLUTION TOPICAL 20051206 OTC MONOGRAPH FINAL part333C Perrigo New York Inc TOLNAFTATE 1 mg/100mL 45802-034_24d40195-c943-467e-bf84-861878728fa0 45802-034 HUMAN OTC DRUG Tolnaftate Tolnaftate POWDER TOPICAL 20051207 OTC MONOGRAPH FINAL part333 Perrigo New York Inc TOLNAFTATE 1 g/100g 45802-038_737a69ce-6649-4a86-8115-5bd0dfdec467 45802-038 HUMAN PRESCRIPTION DRUG erythromycin erythromycin SOLUTION TOPICAL 20111219 ANDA ANDA063038 Perrigo New York Inc ERYTHROMYCIN 20 mg/mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 45802-040_3e33ff46-9dfd-4817-bdff-5010e13c1990 45802-040 HUMAN PRESCRIPTION DRUG SELENIUM SULFIDE SELENIUM SULFIDE LOTION TOPICAL 20060925 ANDA ANDA089996 Perrigo New York Inc SELENIUM SULFIDE 2.5 mg/100mL 45802-046_df562f21-e0cc-433e-ab69-88138e30638c 45802-046 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate OINTMENT TOPICAL 20060710 ANDA ANDA062351 Perrigo New York Inc GENTAMICIN SULFATE 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 45802-048_4165adea-6467-4085-9cbf-aedff4baeae6 45802-048 HUMAN PRESCRIPTION DRUG Nystatin Nystatin OINTMENT TOPICAL 20060915 ANDA ANDA062472 Perrigo New York Inc NYSTATIN 100000 [USP&apos'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 45802-049_c8e329db-3060-4278-aa5a-1a04007cba43 45802-049 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20061110 ANDA ANDA087385 Perrigo New York Inc TRIAMCINOLONE ACETONIDE 5 mg/g 45802-050_903d0d29-2263-4346-8204-663d2d98a322 45802-050 HUMAN OTC DRUG dibucaine dibucaine OINTMENT TOPICAL 20110620 OTC MONOGRAPH FINAL part346 Perrigo New York Inc DIBUCAINE 1 g/100g 45802-053_b37e5a3f-c1c3-4ebf-bb95-30a3ee3d7629 45802-053 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate AEROSOL, FOAM TOPICAL 20130115 ANDA ANDA078337 Perrigo New York Inc BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-054_c8e329db-3060-4278-aa5a-1a04007cba43 45802-054 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20060512 ANDA ANDA087356 Perrigo New York Inc TRIAMCINOLONE ACETONIDE .25 mg/g 45802-055_c8e329db-3060-4278-aa5a-1a04007cba43 45802-055 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20060804 ANDA ANDA087357 Perrigo New York Inc TRIAMCINOLONE ACETONIDE 1 mg/g 45802-056_864cbb1d-bf03-438f-bcf7-702791eb2735 45802-056 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate CREAM TOPICAL 20060823 ANDA ANDA062307 Perrigo New York Inc GENTAMICIN SULFATE 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 45802-057_49924f8e-7dff-425f-b5dc-9d379e052ea3 45802-057 HUMAN OTC DRUG Ibuprofen ibuprofen SUSPENSION ORAL 20140409 ANDA ANDA075217 Perrigo New York Inc IBUPROFEN 50 mg/1.25mL 45802-059_b60134cc-ea96-4190-aec6-e2efe0bfe0d4 45802-059 HUMAN PRESCRIPTION DRUG Nystatin Nystatin CREAM TOPICAL 20060921 ANDA ANDA062225 Perrigo New York Inc NYSTATIN 100000 [USP&apos'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 45802-060_86f89482-c0ff-4b94-bfd5-9129a722e948 45802-060 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20110620 OTC MONOGRAPH FINAL part333B Perrigo New York Inc BACITRACIN 500 [USP'U]/g 45802-061_fabfc46c-9e26-4139-b85d-8c6e4a33192b 45802-061 HUMAN OTC DRUG triple antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20110307 OTC MONOGRAPH FINAL part333B Perrigo New York Inc BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 45802-063_58848cfd-fa68-43ee-815b-4376894bf50d 45802-063 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20061009 ANDA ANDA086415 Perrigo New York Inc TRIAMCINOLONE ACETONIDE .25 mg/g 45802-064_58848cfd-fa68-43ee-815b-4376894bf50d 45802-064 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20060928 ANDA ANDA086414 Perrigo New York Inc TRIAMCINOLONE ACETONIDE 1 mg/g 45802-065_58848cfd-fa68-43ee-815b-4376894bf50d 45802-065 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20060517 ANDA ANDA086413 Perrigo New York Inc TRIAMCINOLONE ACETONIDE 5 mg/g 45802-076_701a9c03-0e53-8e42-64f8-08a79c98888b 45802-076 HUMAN PRESCRIPTION DRUG Imiquimod imiquimod CREAM TOPICAL 20100420 NDA NDA020723 Perrigo New York Inc. IMIQUIMOD 50 mg/1000mg Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 45802-083_059323b0-1034-4cc3-96b8-31af3c0c6d22 45802-083 HUMAN PRESCRIPTION DRUG Erythromycin-Benzoyl Peroxide erythromycin and benzoyl peroxide KIT 20130507 NDA AUTHORIZED GENERIC NDA050557 Perrigo New York Inc 45802-083_4affcac1-7e58-4248-8466-d4b0395fa663 45802-083 HUMAN PRESCRIPTION DRUG Erythromycin-Benzoyl Peroxide erythromycin and benzoyl peroxide KIT 19841026 NDA AUTHORIZED GENERIC NDA050557 Perrigo New York Inc 45802-094_2e09fdb0-4f87-4a28-ad3e-7ce6354184b6 45802-094 HUMAN PRESCRIPTION DRUG hydrocortisone acetate pramoxine hcl hydrocortisone acetate pramoxine hcl KIT 20100915 UNAPPROVED DRUG OTHER Perrigo New York Inc 45802-098_f58a6339-1143-4798-8daa-9fed6b5636a1 45802-098 HUMAN PRESCRIPTION DRUG Mesalamine Mesalamine ENEMA RECTAL 20071011 ANDA ANDA076751 Perrigo New York Inc MESALAMINE 4 g/60mL Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 45802-101_0ba5e88c-a4d5-4550-93fa-d3d7fee45f9f 45802-101 HUMAN OTC DRUG benzoyl peroxide Benzoyl peroxide GEL TOPICAL 20120313 OTC MONOGRAPH FINAL part333D Perrigo New York Inc BENZOYL PEROXIDE 2.5 g/100g 45802-106_ac8573a8-bff4-400d-a9d9-54bab8c3b071 45802-106 HUMAN OTC DRUG Loratadine D Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120119 ANDA ANDA076050 Perrigo New York Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 45802-107_4a4da1e6-2ad1-47f7-a9b3-7d845962ef3b 45802-107 HUMAN OTC DRUG pseudoephedrine hydrochloride Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140524 ANDA ANDA075153 Perrigo New York Inc PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 45802-110_c8124e5c-5665-491c-a489-93a6001a04a1 45802-110 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20140409 ANDA ANDA076779 Perrigo New York Inc NICOTINE 4 mg/1 45802-112_e6cab8f5-5983-4fa9-9891-3cd8e1b554c9 45802-112 HUMAN PRESCRIPTION DRUG mupirocin Mupirocin OINTMENT TOPICAL 20091030 ANDA ANDA065123 Perrigo New York Inc MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 45802-118_7296b4a2-f180-4887-a8e0-029f81aec566 45802-118 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate SOLUTION TOPICAL 20081211 ANDA ANDA077180 Perrigo New York Inc MOMETASONE FUROATE 1 mg/mL 45802-119_63f7acdb-be01-46c6-b799-66ae97cab15f 45802-119 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20080718 ANDA ANDA076067 Perrigo New York Inc MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 45802-124_982f0862-2be8-4a65-8b61-8f3a95ab5951 45802-124 HUMAN PRESCRIPTION DRUG hydrocortisone acetate pramoxine HCl Hydrocortisone Acetate, Pramoxine HCl CREAM TOPICAL 20110329 UNAPPROVED DRUG OTHER Perrigo New York Inc HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 2.5; 1 g/100g; g/100g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-129_fa53c2f2-53be-4ab9-950f-4b587365832d 45802-129 HUMAN PRESCRIPTION DRUG Halobetasol Propionate Halobetasol Propionate CREAM TOPICAL 20080804 ANDA ANDA077123 Perrigo New York Inc HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-131_651e4050-bc06-4037-aea1-e38cd9f95b32 45802-131 HUMAN PRESCRIPTION DRUG Halobetasol Propionate Halobetasol Propionate OINTMENT TOPICAL 20090205 ANDA ANDA076872 Perrigo New York Inc HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-132_6ed5544e-c2f4-4d1d-b995-72e30922ff9d 45802-132 HUMAN PRESCRIPTION DRUG fenofibrate fenofibrate TABLET ORAL 20140923 ANDA ANDA090715 Perrigo New York Inc FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 45802-133_2457c045-0b7c-48f4-9422-11623f13d8f1 45802-133 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20140409 ANDA ANDA074937 Perrigo New York Inc IBUPROFEN 100 mg/5mL 45802-138_5ff2ff89-3a9a-4bdd-9ec9-64be9047a214 45802-138 HUMAN PRESCRIPTION DRUG Ciclopirox Olamine Ciclopirox Olamine CREAM TOPICAL 20060719 ANDA ANDA077364 Perrigo New York Inc CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 45802-140_efb728f2-fe74-4833-8f0c-710d833abf6e 45802-140 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20140409 ANDA ANDA074937 Perrigo New York Inc IBUPROFEN 100 mg/5mL 45802-141_02f46b6e-b424-4210-83bf-e79618df4344 45802-141 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SOLUTION TOPICAL 20070919 ANDA ANDA077623 Perrigo New York Inc CICLOPIROX 2.9 g/6.6mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 45802-143_28fff253-ddd4-4669-aa90-b4caf48c905f 45802-143 HUMAN OTC DRUG triple antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20140520 OTC MONOGRAPH FINAL part333B Perrigo New York Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 45802-144_9eea5875-d153-4bba-aee2-b1d1cd8b5e57 45802-144 HUMAN PRESCRIPTION DRUG hydrocortisone acetate pramoxine hcl hydrocortisone acetate pramoxine hcl CREAM TOPICAL 20100413 UNAPPROVED DRUG OTHER Perrigo New York Inc HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 1; 1 g/100g; g/100g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-151_f8711331-6ce7-48d0-8627-d79f625bcf65 45802-151 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20140114 ANDA ANDA090256 Perrigo New York Inc FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-170_f52c7544-1b6d-4f5e-a477-46cf005ba4fc 45802-170 HUMAN PRESCRIPTION DRUG Urea Urea CREAM TOPICAL 20100817 UNAPPROVED DRUG OTHER Perrigo New York Inc UREA 400 mg/g 45802-171_3b557d61-93f3-4477-a4b1-f1a2ec860f6f 45802-171 HUMAN PRESCRIPTION DRUG Urea Urea GEL TOPICAL 20110613 UNAPPROVED DRUG OTHER Perrigo New York Inc UREA 40 g/100mL 45802-174_b5109d5c-7849-46b3-9bd6-44eac11ba556 45802-174 HUMAN OTC DRUG Muscle Rub Menthol, Methyl salicylate CREAM TOPICAL 20110303 OTC MONOGRAPH NOT FINAL part348 Perrigo New York Inc MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g 45802-176_900b67ee-a561-4dc8-a189-4cc48a192d59 45802-176 HUMAN PRESCRIPTION DRUG urea Urea LOTION TOPICAL 20100604 UNAPPROVED DRUG OTHER Perrigo New York Inc UREA 40 g/100mL 45802-182_e41ff0ec-a36e-4022-8130-6f34cb1da338 45802-182 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20060105 ANDA ANDA019049 Perrigo New York Inc TRETINOIN .025 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 45802-183_e41ff0ec-a36e-4022-8130-6f34cb1da338 45802-183 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20051201 ANDA ANDA017340 Perrigo New York Inc TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 45802-188_43826c68-0a20-460d-a7b5-f3e12395a7d0 45802-188 HUMAN OTC DRUG Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20131101 OTC MONOGRAPH FINAL part346 Perrigo New York Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 45802-201_a426dd82-b2d6-405e-b0af-cfb1310a6e19 45802-201 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20140409 OTC MONOGRAPH NOT FINAL part343 Perrigo New York Inc ACETAMINOPHEN 160 mg/5mL 45802-203_227c6c1c-c942-4923-a25c-a0c28327382c 45802-203 HUMAN OTC DRUG childrens acetaminophen Acetaminophen SUSPENSION ORAL 20140409 OTC MONOGRAPH NOT FINAL part343 Perrigo New York Inc ACETAMINOPHEN 160 mg/5mL 45802-206_eef727aa-9264-401e-9b39-346ce64c81e6 45802-206 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20140409 ANDA ANDA078325 Perrigo New York Inc NICOTINE 2 mg/1 45802-210_36454040-1afb-4363-8f2f-98ff29c82255 45802-210 HUMAN PRESCRIPTION DRUG nitroglycerin lingual Nitroglycerin SPRAY ORAL 20130920 ANDA ANDA091496 Perrigo New York Inc NITROGLYCERIN 400 ug/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 45802-216_7441981a-654d-4f18-be21-66c863ee6d6f 45802-216 HUMAN OTC DRUG benzoyl peroxide BENZOYL PEROXIDE GEL TOPICAL 20120313 OTC MONOGRAPH FINAL part333D Perrigo New York Inc BENZOYL PEROXIDE 5 g/100g 45802-221_f7998817-1273-49ab-a8a2-6603623926b1 45802-221 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate OINTMENT TOPICAL 20070709 ANDA ANDA076668 Perrigo New York Inc FLUTICASONE PROPIONATE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-222_b8b52e17-5277-4166-af54-503d62807341 45802-222 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate CREAM TOPICAL 20060913 ANDA ANDA076793 Perrigo New York Inc FLUTICASONE PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-237_55489b6e-8534-475c-9ccc-c2ed065223d3 45802-237 HUMAN PRESCRIPTION DRUG Salicylic Acid Salicylic Acid SHAMPOO TOPICAL 20080825 UNAPPROVED DRUG OTHER Perrigo New York Inc SALICYLIC ACID 6 mL/100mL 45802-245_b1fc0c63-c821-4874-aba2-bcaa3cda8ad0 45802-245 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120807 ANDA ANDA202319 Perrigo New York Inc LANSOPRAZOLE 15 mg/1 45802-257_adf35e2a-0e7d-41cf-b545-0527687bf061 45802-257 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20041221 ANDA ANDA076679 Perrigo New York Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 45802-263_03b76687-3339-4e83-ae92-3100858d3752 45802-263 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate Clindamycin Phosphate SOLUTION TOPICAL 20060531 ANDA ANDA065049 Perrigo New York Inc CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 45802-269_17b7142f-c651-462c-8e1d-221502267814 45802-269 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20060811 ANDA ANDA076369 Perrigo New York Inc PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] 45802-276_c98da1c3-e538-42f6-b896-59ace6862373 45802-276 HUMAN OTC DRUG hydrocortisone hydrocortisone OINTMENT TOPICAL 20110818 OTC MONOGRAPH NOT FINAL part348 Perrigo New York Inc HYDROCORTISONE 1 g/100g 45802-280_0d685ec1-1459-415e-8277-2af6b55b893a 45802-280 HUMAN OTC DRUG benzoyl peroxide BENZOYL PEROXIDE LIQUID TOPICAL 20130124 OTC MONOGRAPH FINAL part333D Perrigo New York Inc BENZOYL PEROXIDE 5 g/100g 45802-282_fc90a96f-79e0-4c52-8310-0f21f6dd346c 45802-282 HUMAN OTC DRUG Phenol Phenol SPRAY ORAL 20110629 OTC MONOGRAPH NOT FINAL part356 Perrigo New York Inc PHENOL 1.4 mL/100mL 45802-283_75a4df6f-157d-4882-86fa-10a3d8e21b9a 45802-283 HUMAN OTC DRUG Hydrocortisone HYDROCORTISONE LOTION TOPICAL 20110207 OTC MONOGRAPH NOT FINAL part348 Perrigo New York Inc HYDROCORTISONE 1 g/mL 45802-300_1b2cfbbc-e808-4f53-98e6-f0aae5f92bf4 45802-300 HUMAN PRESCRIPTION DRUG clobetasol propionate Clobetasol Propionate SOLUTION TOPICAL 20130601 ANDA ANDA091167 Perrigo New York Inc CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-303_9098d48d-b9bb-4be6-9524-21213bad46d1 45802-303 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20060519 ANDA ANDA088832 Perrigo New York Inc PREDNISONE 10 mg/1 45802-308_9702add4-ea36-4c6b-9402-87b44f989a80 45802-308 HUMAN OTC DRUG benzoyl peroxide BENZOYL PEROXIDE GEL TOPICAL 20120406 OTC MONOGRAPH FINAL part333D Perrigo New York Inc BENZOYL PEROXIDE 10 g/100g 45802-315_6ed5544e-c2f4-4d1d-b995-72e30922ff9d 45802-315 HUMAN PRESCRIPTION DRUG fenofibrate fenofibrate TABLET ORAL 20140813 ANDA ANDA090715 Perrigo New York Inc FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 45802-318_8730957f-f051-4aa5-b5ab-3186051b3789 45802-318 HUMAN OTC DRUG benzoyl peroxide BENZOYL PEROXIDE LIQUID TOPICAL 20130220 OTC MONOGRAPH FINAL part333D Perrigo New York Inc BENZOYL PEROXIDE 10 g/100g 45802-327_53eff898-50bb-402b-aa55-dec5421a6eb6 45802-327 HUMAN OTC DRUG phenol Phenol SPRAY ORAL 20101209 OTC MONOGRAPH NOT FINAL part356 Perrigo New York Inc PHENOL 1.4 g/100mL 45802-338_0ed478d6-7814-4f05-9a6c-a0584dd8f7ba 45802-338 HUMAN PRESCRIPTION DRUG hydroquinone time release Hydroquinone CREAM TOPICAL 20080424 UNAPPROVED DRUG OTHER Perrigo New York Inc HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 45802-344_157e5479-28d6-4493-a8cf-597b9e5622c0 45802-344 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex LOZENGE ORAL 20140331 ANDA ANDA077007 Perrigo New York Inc NICOTINE 2 mg/1 45802-346_34ae2ed9-5d90-486b-9e31-1f406f5db431 45802-346 HUMAN PRESCRIPTION DRUG hydrocortisone acetate pramoxine hcl hydrocortisone acetate pramoxine hcl KIT 20100915 UNAPPROVED DRUG OTHER Perrigo New York Inc 45802-354_e0d48ede-99d0-4f20-861a-f457cd3cc46e 45802-354 HUMAN OTC DRUG Hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 20101004 OTC MONOGRAPH FINAL part346 Perrigo New York Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 45802-356_7d86923c-29fe-4cad-8210-a5f49d669e84 45802-356 HUMAN OTC DRUG Trolamine Salicylate Trolamine Salicylate CREAM TOPICAL 20101126 OTC MONOGRAPH NOT FINAL part348 Perrigo New York Inc TROLAMINE SALICYLATE 10 g/100g 45802-358_b26fa184-9538-45db-9387-1af99bb1e407 45802-358 HUMAN OTC DRUG diphenhydramine hcl and zinc acetate Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20051205 OTC MONOGRAPH NOT FINAL part348 Perrigo New York Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 45802-361_e41ff0ec-a36e-4022-8130-6f34cb1da338 45802-361 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20060105 ANDA ANDA017522 Perrigo New York Inc TRETINOIN .05 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 45802-362_e41ff0ec-a36e-4022-8130-6f34cb1da338 45802-362 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20051202 ANDA ANDA017955 Perrigo New York Inc TRETINOIN .01 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 45802-363_e41ff0ec-a36e-4022-8130-6f34cb1da338 45802-363 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20051201 ANDA ANDA017579 Perrigo New York Inc TRETINOIN .025 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 45802-368_bff0ccf5-4a56-4df3-893a-5b621e2355db 45802-368 HUMAN PRESCRIPTION DRUG Imiquimod Imiquimod CREAM TOPICAL 20101109 ANDA ANDA078837 Perrigo New York Inc IMIQUIMOD 12.5 mg/.25g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 45802-376_228133fe-4642-419c-bf26-5b305f130d17 45802-376 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20060928 ANDA ANDA076592 Perrigo New York Inc BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-390_7b6280e3-cbeb-4385-8ab8-263e4405cb6c 45802-390 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus OINTMENT TOPICAL 20141120 NDA NDA050777 Perrigo New York Inc TACROLIMUS .3 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 45802-395_77aa1453-6c05-40f8-97f9-06d486876e99 45802-395 HUMAN OTC DRUG vitamin a and d Lanolin, Petrolatum OINTMENT TOPICAL 20110503 OTC MONOGRAPH FINAL part347 Perrigo New York Inc LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g 45802-400_dbd4f19e-c345-4862-9d92-831d052d02bf 45802-400 HUMAN PRESCRIPTION DRUG Ciclopirox Olamine Ciclopirox Olamine SUSPENSION TOPICAL 20061229 ANDA ANDA077676 Perrigo New York Inc CICLOPIROX OLAMINE 7.7 mg/100mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 45802-401_c3722d52-407c-499b-a08b-b299609f203c 45802-401 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SHAMPOO TOPICAL 20100217 ANDA ANDA078594 Perrigo New York Inc CICLOPIROX 1 mL/100mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 45802-410_d6317877-39ff-4c94-b6c0-ba057c80b856 45802-410 HUMAN OTC DRUG oxymetazoline hcl oxymetazoline hydrochloride SPRAY NASAL 20051205 OTC MONOGRAPH FINAL part341 Perrigo New York Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 45802-419_3657210a-37b0-472c-be09-17ea4e61713f 45802-419 HUMAN PRESCRIPTION DRUG Ammonium Lactate Ammonium Lactate LOTION TOPICAL 20060620 ANDA ANDA075570 Perrigo New York Inc AMMONIUM LACTATE 12 g/100g 45802-422_7827a3b6-9fee-412d-a569-54e876803c9f 45802-422 HUMAN PRESCRIPTION DRUG Desonide Desonide CREAM TOPICAL 20060411 NDA NDA017010 Perrigo New York Inc DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-423_9301c890-101b-428c-bdfc-d381fd66eae2 45802-423 HUMAN PRESCRIPTION DRUG Desonide Desonide OINTMENT TOPICAL 20060822 NDA NDA017426 Perrigo New York Inc DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-425_ad8e64d5-d49e-4149-a452-d319c2faf714 45802-425 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20110808 ANDA ANDA076447 Perrigo New York Inc FEXOFENADINE HYDROCHLORIDE 60 mg/1 45802-432_458594e1-8d99-4de3-8923-2fd8ce2fc406 45802-432 HUMAN OTC DRUG pseudoephedrine hydrochloride Pseudoephedrine HCl TABLET, FILM COATED ORAL 20081017 OTC MONOGRAPH FINAL part341 Perrigo New York Inc PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 45802-433_7a6b68eb-8fe0-447d-aed7-28432c45b58c 45802-433 HUMAN OTC DRUG dextromethorphan polistirex extended release dextromethorphan polistirex SUSPENSION ORAL 20120910 ANDA ANDA091135 Perrigo New York Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 45802-434_071278e7-550a-4bc0-958c-cfb692c8a9af 45802-434 HUMAN OTC DRUG clotrimazole Clotrimazole CREAM TOPICAL 20110603 OTC MONOGRAPH FINAL part333C Perrigo New York Inc CLOTRIMAZOLE 1 g/100g 45802-437_3f75880b-9ead-4c6e-b999-3bd7e1643ce5 45802-437 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol propionate AEROSOL, FOAM TOPICAL 20080320 ANDA ANDA077763 Perrigo New York Inc CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-438_b3205777-1485-492f-840f-ce5c977405dd 45802-438 HUMAN OTC DRUG hydrocortisone Hydrocortisone CREAM TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part348 Perrigo New York Inc HYDROCORTISONE 1 g/100g 45802-441_f0755988-0912-4c1e-815a-890e592a140f 45802-441 HUMAN PRESCRIPTION DRUG fluticasone propionate fluticasone propionate LOTION TOPICAL 20130808 ANDA ANDA091553 Perrigo New York Inc FLUTICASONE PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-453_f41b3fb3-005f-4ef2-9f16-9a05559c9d68 45802-453 HUMAN PRESCRIPTION DRUG Adapalene Adapalene CREAM TOPICAL 20101026 NDA NDA020748 Perrigo New York Inc ADAPALENE .1 g/100g Retinoid [EPC],Retinoids [Chemical/Ingredient] 45802-455_bdffc20d-f4d9-4b7c-b752-a783f284e1d6 45802-455 HUMAN PRESCRIPTION DRUG Hydrocortisone Valerate Hydrocortisone Valerate CREAM TOPICAL 20091202 ANDA ANDA075666 Perrigo New York Inc HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-465_b2ce0106-b2c3-4c4d-8dac-40050f6ea4ae 45802-465 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole SHAMPOO, SUSPENSION TOPICAL 20100119 ANDA ANDA076419 Perrigo New York Inc KETOCONAZOLE 20 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 45802-466_78b86d5d-434b-43cc-a2cb-90bc19aaf6b9 45802-466 HUMAN PRESCRIPTION DRUG Econazole Nitrate Econazole Nitrate CREAM TOPICAL 20060808 ANDA ANDA076479 Perrigo New York Inc ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 45802-472_87a4c494-56f9-48f6-8592-d610c507a4fc 45802-472 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate Pramoxine Hcl Hydrocortisone Acetate Pramoxine Hcl CREAM TOPICAL 19960927 UNAPPROVED DRUG OTHER Perrigo New York Inc HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 2.5; 1 g/100g; g/100g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-484_34ea3cb5-fac4-4d2b-ac5f-4455141fea3c 45802-484 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20140409 OTC MONOGRAPH NOT FINAL part343 Perrigo New York Inc ACETAMINOPHEN 500 mg/1 45802-486_de26b0f8-0b65-41c1-8d48-509cff5b6d86 45802-486 HUMAN OTC DRUG Docusate Sodium Docusate sodium CAPSULE, LIQUID FILLED ORAL 20081028 OTC MONOGRAPH NOT FINAL part334 Perrigo New York Inc DOCUSATE SODIUM 100 mg/1 45802-490_cdb60f74-ce23-4015-90eb-b23a2275f6cb 45802-490 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140411 ANDA ANDA074661 Perrigo New York Inc NAPROXEN SODIUM 220 mg/1 45802-493_878e1623-10a7-452c-9b69-8596162e4f10 45802-493 HUMAN PRESCRIPTION DRUG Ammonium Lactate Ammonium Lactate CREAM TOPICAL 20060816 ANDA ANDA075774 Perrigo New York Inc AMMONIUM LACTATE 12 g/100g 45802-495_df05a51c-aeb0-4297-8a31-7ec7d01363a7 45802-495 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 20061024 ANDA ANDA076510 Perrigo New York Inc DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-498_25879740-0310-4bfa-834c-e7625d7cb380 45802-498 HUMAN OTC DRUG Guaifenesin Extended Release Guaifenesin TABLET, EXTENDED RELEASE ORAL 20120328 ANDA ANDA078912 Perrigo New York Inc GUAIFENESIN 600 mg/1 45802-532_f86c0582-f82e-4cc1-981c-26f8e9a38919 45802-532 HUMAN PRESCRIPTION DRUG ketoconazole ketoconazole AEROSOL, FOAM TOPICAL 20110830 ANDA ANDA091550 Perrigo New York Inc KETOCONAZOLE 2 g/100g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 45802-562_439480fd-fdce-44e6-889e-1ba5011c9607 45802-562 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate Clindamycin Phosphate SOLUTION TOPICAL 20130917 ANDA ANDA064050 Perrigo New York Inc CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 45802-571_cce5b39f-dd3f-4621-8a18-454756c4eb7e 45802-571 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110422 ANDA ANDA076447 Perrigo New York Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 45802-572_63922da2-a24f-466e-843a-d732ca867e5d 45802-572 HUMAN OTC DRUG bisacodyl stimulant laxative bisacodyl SUPPOSITORY RECTAL 20120927 OTC MONOGRAPH NOT FINAL part334 Perrigo New York Inc BISACODYL 10 mg/1 45802-608_a0f1c670-7c45-4e3b-aa05-99144945a96d 45802-608 HUMAN PRESCRIPTION DRUG calcitriol calcitriol OINTMENT TOPICAL 20120308 NDA NDA022087 Perrigo New York Inc CALCITRIOL 3 ug/g Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 45802-626_2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e 45802-626 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine hydrochloride SYRUP ORAL 20080724 ANDA ANDA078398 Perrigo New York Inc CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 45802-637_15a29531-d197-48af-bea3-d60d0e4dbfa6 45802-637 HUMAN PRESCRIPTION DRUG clobetasol propionate emollient formulation clobetasol propionate AEROSOL, FOAM TOPICAL 20130201 ANDA ANDA201402 Perrigo New York Inc CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-650_e760545b-01f8-4856-8437-87fbe1b985d0 45802-650 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 Perrigo New York Inc LORATADINE 10 mg/1 45802-660_92f7ea81-fc0c-4586-98a7-a6aa6ba5e0a1 45802-660 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate clindamycin phosphate AEROSOL, FOAM TOPICAL 20100331 ANDA ANDA090785 Perrigo New York Inc CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 45802-680_2fae10f5-b2ca-4d9b-974f-8006efe62988 45802-680 HUMAN PRESCRIPTION DRUG levocetirizine dihydrochloride Levocetirizine dihydrochloride SOLUTION ORAL 20111107 ANDA ANDA091263 Perrigo New York Inc LEVOCETIRIZINE DIHYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 45802-700_7b6280e3-cbeb-4385-8ab8-263e4405cb6c 45802-700 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus OINTMENT TOPICAL 20141120 NDA NDA050777 Perrigo New York Inc TACROLIMUS 1 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 45802-701_13a34575-453a-4dbf-8576-eb1a74ff6b48 45802-701 HUMAN OTC DRUG Antifungal Tolnaftate SOLUTION TOPICAL 20110817 OTC MONOGRAPH FINAL part333C Perrigo New York Inc TOLNAFTATE 1 mg/100mL 45802-710_671ac829-509e-40de-9247-35ea0c5cda27 45802-710 HUMAN OTC DRUG Bisacodyl Bisacodyl SUPPOSITORY RECTAL 20110506 OTC MONOGRAPH NOT FINAL part334 Perrigo New York Inc BISACODYL 10 mg/1 45802-717_0e68edfe-972b-4763-8549-6e40120ca53b 45802-717 HUMAN PRESCRIPTION DRUG Terconazole Terconazole SUPPOSITORY VAGINAL 20060828 ANDA ANDA077149 Perrigo New York Inc TERCONAZOLE 80 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 45802-721_7e7adf5d-c1ce-4366-931e-1455c39985f1 45802-721 HUMAN OTC DRUG Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080410 ANDA ANDA077170 Perrigo New York Inc CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 45802-730_ce23de91-801d-45c5-9579-4928a01e0871 45802-730 HUMAN OTC DRUG acetaminophen pain reliever fever reducer Acetaminophen SUPPOSITORY RECTAL 20101028 ANDA ANDA070608 Perrigo New York Inc ACETAMINOPHEN 650 mg/1 45802-732_6dff643c-8fc3-4c1d-b7f1-89775c349120 45802-732 HUMAN OTC DRUG acetaminophen for children Acetaminophen SUPPOSITORY RECTAL 20101214 ANDA ANDA070607 Perrigo New York Inc ACETAMINOPHEN 120 mg/1 45802-733_3f8150f3-3e63-4b6d-a5b6-0305043c13e3 45802-733 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20061002 ANDA ANDA080292 Perrigo New York Inc PREDNISONE 5 mg/1 45802-736_d5b4cf7f-c277-4c2a-82ab-ad06b7356ae7 45802-736 HUMAN PRESCRIPTION DRUG clindamycin phosphate and benzoyl peroxide Clindamycin, Benzoyl Peroxide GEL TOPICAL 20120626 ANDA ANDA090979 Perrigo New York Inc BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 50; 10 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 45802-758_fb3c9368-575b-4e9e-ab68-a63566293b2e 45802-758 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20060627 ANDA ANDA040500 Perrigo New York Inc PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 45802-759_fb3c9368-575b-4e9e-ab68-a63566293b2e 45802-759 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20060517 ANDA ANDA040500 Perrigo New York Inc PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 45802-770_5eda246b-ac51-46e7-b473-35937f84ed05 45802-770 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077295 Perrigo New York Inc GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 45802-806_1d02249e-af19-4437-b726-702ee11501e0 45802-806 HUMAN PRESCRIPTION DRUG salicylic acid Salicylic Acid CREAM TOPICAL 20070907 UNAPPROVED DRUG OTHER Perrigo New York Inc SALICYLIC ACID 6 g/100g 45802-818_1d02249e-af19-4437-b726-702ee11501e0 45802-818 HUMAN PRESCRIPTION DRUG salicylic acid Salicylic Acid LOTION TOPICAL 20070927 UNAPPROVED DRUG OTHER Perrigo New York Inc SALICYLIC ACID 6 mL/100mL 45802-822_b627bd98-13b2-4340-9d67-d23e7e6a24d1 45802-822 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077295 Perrigo New York Inc GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 45802-840_350f3964-361e-4f5a-ba5e-4c7d2c3e8dff 45802-840 HUMAN PRESCRIPTION DRUG Levonorgestrel Emergency Contraceptive Levonorgestrel TABLET ORAL 20110310 ANDA ANDA090740 Perrigo New York Inc LEVONORGESTREL .75 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 45802-868_ec0bad03-9e55-4c7f-a524-955f20b81078 45802-868 HUMAN OTC DRUG Polyethylene Glycol 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091013 ANDA ANDA090685 Perrigo New York Inc POLYETHYLENE GLYCOL 3350 17 g/17g 45802-873_8d4dfba9-1571-4128-9cdc-47cdce04e3e4 45802-873 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex LOZENGE ORAL 20140331 ANDA ANDA077007 Perrigo New York Inc NICOTINE 4 mg/1 45802-888_63b120ca-6b27-464a-a018-c28a38cf25fd 45802-888 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080225 NDA NDA022032 Perrigo New York Inc OMEPRAZOLE 20 mg/1 45802-896_6e55840a-606e-4f56-acdb-a53e0d72f5bc 45802-896 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium LOTION TOPICAL 20121017 ANDA ANDA078649 Perrigo New York Inc SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 45802-897_9a9c34e9-c5ed-46e0-bb36-fac399ac1389 45802-897 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION ORAL 20111117 ANDA ANDA074937 Perrigo New York Inc IBUPROFEN 100 mg/5mL 45802-905_6b258f99-4757-4a5d-8591-1b104b548ccc 45802-905 HUMAN PRESCRIPTION DRUG Benzoyl Peroxide aqueous base Benzoyl Peroxide GEL TOPICAL 20080924 UNAPPROVED DRUG OTHER Perrigo New York Inc BENZOYL PEROXIDE 2.5 g/100g 45802-907_bd0ee0c2-9c54-477a-ba86-72405fded105 45802-907 HUMAN PRESCRIPTION DRUG benzoyl peroxide benzoyl peroxide LIQUID TOPICAL 20080208 UNAPPROVED DRUG OTHER Perrigo New York Inc BENZOYL PEROXIDE 2.5 g/100g 45802-910_19004b02-2e4b-4d66-aa84-7a19ad8c3c69 45802-910 HUMAN PRESCRIPTION DRUG Perrigo Benzoyl Peroxide Aqueous Base Benzoyl Peroxide GEL TOPICAL 20080807 UNAPPROVED DRUG OTHER Perrigo New York Inc BENZOYL PEROXIDE 5 g/100g 45802-913_2562e53d-fb83-404a-a011-9e6d9b982be5 45802-913 HUMAN PRESCRIPTION DRUG Perrigo Benzoyl Peroxide wash Benzoyl Peroxide LOTION TOPICAL 20080415 UNAPPROVED DRUG OTHER Perrigo New York Inc BENZOYL PEROXIDE 5 g/100g 45802-915_97ce130e-d6e8-486d-b075-04ff753d7916 45802-915 HUMAN PRESCRIPTION DRUG Perrigo Benzoyl Peroxide Aqueous Base Benzoyl Peroxide GEL TOPICAL 20081204 UNAPPROVED DRUG OTHER Perrigo New York Inc BENZOYL PEROXIDE 10 g/100g 45802-918_c7b6a57f-50d3-4bef-a092-c66220e30d7b 45802-918 HUMAN PRESCRIPTION DRUG Benzoyl Peroxide Benzoyl Peroxide LIQUID TOPICAL 20080519 UNAPPROVED DRUG OTHER Perrigo New York Inc BENZOYL PEROXIDE 10 g/100g 45802-919_91fe3ab8-c155-4482-9f06-f029d3563aad 45802-919 HUMAN OTC DRUG cetirizine hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA078336 Perrigo New York Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 45802-921_5602bb4c-5e94-4040-90fd-7a0596b81484 45802-921 HUMAN PRESCRIPTION DRUG Perrigo Benzoyl Peroxide hydroalcoholic base Benzoyl Peroxide GEL TOPICAL 20080915 UNAPPROVED DRUG OTHER Perrigo New York Inc BENZOYL PEROXIDE 10 g/100g 45802-923_2f8ec78c-dc73-445c-a967-a29a12d26290 45802-923 HUMAN PRESCRIPTION DRUG Mesalamine Mesalamine KIT 20090901 ANDA ANDA076751 Perrigo New York Inc 45802-923_eb5bcaab-0f86-4817-9373-0a5e5e1982d2 45802-923 HUMAN PRESCRIPTION DRUG Mesalamine Mesalamine KIT 20100217 ANDA ANDA076751 Perrigo New York Inc 45802-925_956664ad-7d3f-4350-8a4a-ef8ccbded6f4 45802-925 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol propionate GEL TOPICAL 20080730 ANDA ANDA075027 Perrigo New York Inc CLOBETASOL PROPIONATE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-930_732e4667-1c2e-4cc9-89d4-55894ca9f8a0 45802-930 HUMAN PRESCRIPTION DRUG hydrocortisone Iodoquinol Hydrocortisone, Iodoquinol CREAM TOPICAL 20080714 UNAPPROVED DRUG OTHER Perrigo New York Inc HYDROCORTISONE; IODOQUINOL 10; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-937_47915785-8516-41d8-8ebc-6a2b72575e70 45802-937 HUMAN PRESCRIPTION DRUG hydrocortisone hydrocortisone LOTION TOPICAL 20080523 ANDA ANDA089074 Perrigo New York Inc HYDROCORTISONE 25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-939_747c86b3-dd8d-41ee-b867-f93ec84462bf 45802-939 HUMAN PRESCRIPTION DRUG Seb Prev Wash Sodium Sulfacetamide LIQUID TOPICAL 20080725 UNAPPROVED DRUG OTHER Perrigo New York Inc SULFACETAMIDE SODIUM 100 mg/.95mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 45802-942_0e76c520-d02a-4064-bcda-fc45cf9e6fa3 45802-942 HUMAN PRESCRIPTION DRUG sodium sulfacetamide 10 and sulfur 5 Sodium Sulfacetamide, Sulfur SOLUTION TOPICAL 20080606 UNAPPROVED DRUG OTHER Perrigo New York Inc SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 45802-946_4a73a53c-45b5-41c9-a5ae-5ec87af9e6fb 45802-946 HUMAN PRESCRIPTION DRUG Perrigo Sodium Sulfacetamide and Sulfur Sodium Sulfacetamide, Sulfur LOTION TOPICAL 20080915 UNAPPROVED DRUG OTHER Perrigo New York Inc SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 45802-947_6e8707b3-2c87-4b08-9dc5-ab347b698042 45802-947 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077295 Perrigo New York Inc GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 45802-950_f5edf6c5-7ef4-42a9-8ee0-306d8874e7ea 45802-950 HUMAN PRESCRIPTION DRUG Perrigo Sodium Sulfacetamide and Sulfur Sodium Sulfacetamide and Sulfur KIT 20080820 UNAPPROVED DRUG OTHER Perrigo New York Inc 45802-952_6faf48fd-b314-4c3c-ad51-ffef455b1b95 45802-952 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20041208 ANDA ANDA076925 Perrigo New York Inc IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 45802-954_746e4edd-4c3e-443a-9775-d64d494f1850 45802-954 HUMAN PRESCRIPTION DRUG Perrigo Seb Prev Sodium Sulfacetamide CREAM TOPICAL 20080807 UNAPPROVED DRUG OTHER Perrigo New York Inc SULFACETAMIDE SODIUM 100 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 45802-960_839f463b-aade-46c9-a0d6-d7ed0c20afc2 45802-960 HUMAN PRESCRIPTION DRUG Perrigo Seb Prev Sodium Sulfacetamide GEL TOPICAL 20080819 UNAPPROVED DRUG OTHER Perrigo New York Inc SULFACETAMIDE SODIUM 100 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 45802-961_39ac9c45-9528-4318-a975-9ad34e946a2c 45802-961 HUMAN PRESCRIPTION DRUG clobetasol propionate Clobetasol Propionate SHAMPOO TOPICAL 20120810 ANDA ANDA090974 Perrigo New York Inc CLOBETASOL PROPIONATE .05 mL/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-962_0c77c8df-3dac-4a7a-abea-71884137e216 45802-962 HUMAN PRESCRIPTION DRUG Ery Erythromycin SOLUTION TOPICAL 20080707 ANDA ANDA064126 Perrigo New York Inc ERYTHROMYCIN .8 mL/100mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 45802-966_868be674-0d72-4075-be98-8d1c903d8675 45802-966 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin GEL TOPICAL 20080612 ANDA ANDA063211 Perrigo New York Inc ERYTHROMYCIN 20 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 45802-968_10694591-2810-4595-a5c1-850e6303efc9 45802-968 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin SUSPENSION ORAL 20080716 ANDA ANDA065200 Perrigo New York Inc GRISEOFULVIN 125 mg/5mL Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 45802-974_c2cf555d-986c-4e89-ac4f-938e92c418e2 45802-974 HUMAN OTC DRUG cetirizine hydrochloride cetirizine hydrochloride LIQUID ORAL 20080415 ANDA ANDA090254 Perrigo New York Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 45802-975_92659b47-0793-406f-942a-70ba1c0c1718 45802-975 HUMAN PRESCRIPTION DRUG Perrigo Hydroquinone with sunscreens Hydroquinone CREAM TOPICAL 20081023 UNAPPROVED DRUG OTHER Perrigo New York Inc DIOXYBENZONE; HYDROQUINONE; OXYBENZONE; PADIMATE O 30; 40; 20; 80 mg/g; mg/g; mg/g; mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 45802-978_ab0da82f-fb5f-4dd7-bd3f-aab9043f1ef4 45802-978 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide and Sulfur Sodium Sulfacetamide and Sulfur KIT 20081008 UNAPPROVED DRUG OTHER Perrigo New York Inc 45802-980_fa7bc764-44fc-4f53-90c9-18b92870ae25 45802-980 HUMAN PRESCRIPTION DRUG Hydroquinone Hydroquinone CREAM TOPICAL 20080617 UNAPPROVED DRUG OTHER Perrigo New York Inc HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 45802-981_254ab28e-9865-4d97-8938-fd1ae565ee1d 45802-981 HUMAN OTC DRUG hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20130213 OTC MONOGRAPH FINAL part346 Perrigo New York Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 45802-982_8d6162b1-422e-4983-a0fa-ad994694cf9e 45802-982 HUMAN PRESCRIPTION DRUG Perrigo Hydroquinone with sunscreens Hydroquinone GEL TOPICAL 20090204 UNAPPROVED DRUG OTHER Perrigo New York Inc DIOXYBENZONE; HYDROQUINONE; PADIMATE O 30; 40; 50 mg/g; mg/g; mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 45802-984_4b466274-58d4-4b0c-891e-13f3ebd11f3e 45802-984 HUMAN PRESCRIPTION DRUG Perrigo Hydroquinone with sunscreens Hydroquinone, Octinoxate, Oxybenzone, Padimate O CREAM TOPICAL 20080923 UNAPPROVED DRUG OTHER Perrigo New York Inc HYDROQUINONE; OCTINOXATE; OXYBENZONE; PADIMATE O 40; 40; 40; 80 mg/g; mg/g; mg/g; mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 45802-989_1054353d-8e33-452b-b96e-5bce10ae3147 45802-989 HUMAN PRESCRIPTION DRUG Calcipotriene and Betamethasone Dipropionate calcipotriene and betamethasone dipropionate OINTMENT TOPICAL 20080601 NDA NDA021852 Perrigo New York Inc BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE .643; 50 mg/g; ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45802-995_e33638b9-bd0e-422c-9ec7-fdb7e501c96e 45802-995 HUMAN PRESCRIPTION DRUG Perrigo Benzoyl Peroxide hydroalcoholic base benzoyl peroxide GEL TOPICAL 20071004 UNAPPROVED DRUG OTHER Perrigo New York Inc BENZOYL PEROXIDE 5 g/100g 45861-001_825b6f71-8b1e-4d9f-b0cc-187db3491f55 45861-001 HUMAN OTC DRUG Medrox METHYL SALICYLATE, MENTHOL, CAPSAICIN OINTMENT TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part348 Pharmaceutica North America CAPSAICIN; MENTHOL; METHYL SALICYLATE .0375; 5; 20 g/100g; g/100g; g/100g 45861-004_7fcf061d-ce22-41b4-90ca-11c4e86a8e94 45861-004 HUMAN OTC DRUG Medrox METHYL SALICYLATE, MENTHOL, CAPSAICIN PATCH TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part348 Pharmaceutica North America CAPSAICIN; MENTHOL; METHYL SALICYLATE .0375; 5; 20 g/100g; g/100g; g/100g 45861-005_0464d781-fa9d-442a-a7a7-94a3c8cf4786 45861-005 HUMAN PRESCRIPTION DRUG Medrox-Rx methyl salicylate, menthol, capsaicin OINTMENT TOPICAL 20111027 OTC MONOGRAPH FINAL part348 Pharmaceutica North America, Inc. CAPSAICIN; MENTHOL; METHYL SALICYLATE .6; 8.4; 24 g/120g; g/120g; g/120g 45861-006_db0c4341-31b8-4527-bcf6-35efd98aef55 45861-006 HUMAN OTC DRUG Endoxcin LIDOCAINE HYDROCHLORIDE and Menthol PATCH TOPICAL 20140505 OTC MONOGRAPH NOT FINAL part348 Pharmaceutica North America, Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g 45861-009_a72be0bf-0af3-4635-9cc8-6cb28252c683 45861-009 HUMAN OTC DRUG Medrox Menthol, CAPSAICIN, methyl salicylate PATCH TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part348 Pharmaceutica North America, Inc. CAPSAICIN; MENTHOL; METHYL SALICYLATE .0375; 5; 5 g/100g; g/100g; g/100g 45861-009_c7f9ca4a-b147-454f-86b5-29bed05500a4 45861-009 HUMAN OTC DRUG Medrox Menthol, CAPSAICIN, methyl salicylate PATCH TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part348 Pharmaceutica North America, Inc. CAPSAICIN; MENTHOL; METHYL SALICYLATE .0375; 5; 5 g/100g; g/100g; g/100g 45861-010_4c78f746-0004-4d30-921a-687961a6742e 45861-010 HUMAN PRESCRIPTION DRUG Sterymine Pain Relief ECHINACEA ANGUSTIFOLIA,ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP,HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ATROPA BELLADONNA, BELLIS PERENNIS, MATRICARIA RECUTITA, ACHILLEA MILLEFOLIUM, HYPERICUM PERFORATUM, COMFREY ROOT, COLCHICINE GEL TOPICAL 20120411 UNAPPROVED HOMEOPATHIC Pharmaceutica North America, Inc. ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA 1; 3; 3; 3; 1; 1; 3; 4; 1; 1; 1; 6; 1 [hp_X]/.015g; [hp_X]/.015g; [hp_X]/.015g; [hp_X]/.015g; [hp_X]/.015g; [hp_X]/.015g; [hp_X]/.015g; [hp_X]/.015g; [hp_X]/.015g; [hp_X]/.015g; [hp_X]/.015g; [hp_X]/.015g; [hp_X]/.015g Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 45861-011_b7de5c70-4b14-4f5c-b1ca-b8e73be4de01 45861-011 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20120809 ANDA ANDA090705 Pharmaceutica North America, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 45861-012_471c3fa2-cde5-4055-a1c2-45da743ac815 45861-012 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20130807 ANDA ANDA091432 Pharmaceutica North America, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 45861-013_c78b4218-a806-46cd-940d-7b92a0a66430 45861-013 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20130807 ANDA ANDA090478 Pharmaceutica North America, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 45861-014_3a32af34-db2f-4ee4-9a63-25e18d2b14b6 45861-014 HUMAN OTC DRUG MEDROX MENTHOL, CAPSAICIN PATCH TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part348 Pharmaceutica North America CAPSAICIN; MENTHOL .0375; 5 g/100g; g/100g 45861-016_de83a65c-18a7-484b-9448-b52d0e5cbb1c 45861-016 HUMAN OTC DRUG LenzaGel LIDOCAINE HYDROCHLORIDE, MENTHOL GEL TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 Pharmaceutica North America, Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g 45861-017_1fb6fe1f-2d2a-47ce-ac4f-29d8b99ed834 45861-017 HUMAN OTC DRUG LenzaPatch LIDOCAINE HYDROCHLORIDE, MENTHOL LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 Pharmaceutica North America, Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g 45861-100_4f2022e4-823d-4378-a63a-9caabea86b0a 45861-100 HUMAN PRESCRIPTION DRUG Gabapentin Kit GABAPENTIN KIT 20120828 ANDA ANDA090705 Pharmaceutica North America, Inc. 45861-101_75b7c18e-1bf8-44ea-b160-3acaa3cbaf5f 45861-101 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE KIT CYCLOBENZAPRINE HYDROCHLORIDE KIT 20130828 ANDA ANDA090478 Pharmaceutica North America, Inc. 45861-102_1889b84f-9c83-4e87-b343-c69df06746d2 45861-102 HUMAN PRESCRIPTION DRUG Naproxen Kit Naproxen KIT 20130828 ANDA ANDA091432 Pharmaceutica North America, Inc 45861-107_c6af6fb2-637b-4fa2-8941-7ed78b4eb51a 45861-107 HUMAN PRESCRIPTION DRUG Active-Medicated specimen collection kit Urine specimen collection kit KIT 20131031 ANDA ANDA078010 Pharmaceutica North America, Inc 45861-108_79cfe36c-07d3-4f42-9118-609b9a22d693 45861-108 HUMAN PRESCRIPTION DRUG ACTIVE-PAC with Gabapentin GABAPENTIN, LIDOCAINE HYDROCHLORIDE, MENTHOL KIT 20140618 ANDA ANDA077242 Pharmaceutica North America, Inc. 45861-111_9e916b9d-b233-44e1-ac33-5acf741611fe 45861-111 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20140212 ANDA ANDA077242 Pharmaceutica North America, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 45861-201_c006f129-e863-45b8-8465-77efee6e5ffe 45861-201 HUMAN OTC DRUG Docuprene DOCUSATE SODIUM TABLET ORAL 20100616 OTC MONOGRAPH NOT FINAL part334 Pharmaceutica North America, Inc. DOCUSATE SODIUM 100 mg/1 45865-342_4c9c1111-c13e-42fc-9c1d-5f9c54c86515 45865-342 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20081217 ANDA ANDA075576 Medsource Pharmaceuticals OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 45865-347_62717c61-b047-49f2-ab29-a852dc5dead2 45865-347 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Medsource Pharmaceuticals GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 45865-348_db154152-f820-455d-a524-34591ca94e87 45865-348 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20081208 ANDA ANDA076286 Medsource Pharmaceuticals TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 45865-364_f4dc2502-bb11-4c1d-a67d-67ea7785749c 45865-364 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Extended-Release Diclofenac Sodium TABLET, EXTENDED RELEASE ORAL 20090105 ANDA ANDA075910 Medsource Pharmaceuticals DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 45865-373_b988f226-d4a8-4fa3-bea3-5f88462613b0 45865-373 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Medsource Pharmaceuticals IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 45865-386_d78e34e6-d2eb-4bfa-8a9f-5f5768345599 45865-386 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20090105 ANDA ANDA076286 Medsource Pharmaceuticals TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 45865-407_feab4bc9-ea2d-41fe-bf5e-99c2897df8b6 45865-407 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA089160 Medsource Pharmaceuticals ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 45865-411_a76f0b27-45c2-48d1-a5e2-a978ef069004 45865-411 HUMAN PRESCRIPTION DRUG HYDROCODONE BIT/APAP HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20110701 ANDA ANDA040400 Medsource Pharmaceuticals ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 45865-412_06640c94-07e3-42ea-ace5-2753b4295c33 45865-412 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040754 Medsource Pharmaceuticals ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 45865-426_0f799403-4e92-4119-a37b-ca4089437fb1 45865-426 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20091201 ANDA ANDA077918 Medsource Pharmaceuticals MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 45865-451_f25a460e-1569-4af3-ac4a-b99f44c51313 45865-451 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20090609 ANDA ANDA075465 Medsource Pharmaceuticals FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 45942-1629_f08d132e-9186-496d-8017-5a2fb8aa6c4d 45942-1629 HUMAN OTC DRUG Refresh Sanitizing Towlette Organic Grapefruit Splash BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100120 OTC MONOGRAPH NOT FINAL part333 GIOVANNI COSMETICS INC BENZALKONIUM CHLORIDE .13 1/1 45942-1630_6cf74644-65e0-44e2-9b34-d54240673ba6 45942-1630 HUMAN OTC DRUG Recharge Sanitizing Towlette Organic Peppermint Surge BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100120 OTC MONOGRAPH NOT FINAL part333 GIOVANNI COSMETICS INC BENZALKONIUM CHLORIDE .13 1/1 45942-1631_e1cfb2e5-c2b4-4010-8054-5daff48a039d 45942-1631 HUMAN OTC DRUG Relax Sanitizing Towlette Organic Lavender Calm BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100120 OTC MONOGRAPH NOT FINAL part333 GIOVANNI COSMETICS INC BENZALKONIUM CHLORIDE .13 1/1 45945-151_b0a7864c-6ee4-424c-afb1-a68f9eb7431b 45945-151 HUMAN PRESCRIPTION DRUG Gablofen baclofen INJECTION INTRATHECAL 20101119 NDA NDA022462 Mallinckrodt Inc (Brand Pharmaceuticals) BACLOFEN 50 ug/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 45945-155_b0a7864c-6ee4-424c-afb1-a68f9eb7431b 45945-155 HUMAN PRESCRIPTION DRUG Gablofen baclofen INJECTION INTRATHECAL 20101119 NDA NDA022462 Mallinckrodt Inc (Brand Pharmaceuticals) BACLOFEN 500 ug/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 45945-156_b0a7864c-6ee4-424c-afb1-a68f9eb7431b 45945-156 HUMAN PRESCRIPTION DRUG Gablofen baclofen INJECTION INTRATHECAL 20120710 NDA NDA022462 Mallinckrodt Inc (Brand Pharmaceuticals) BACLOFEN 1000 ug/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 45945-157_b0a7864c-6ee4-424c-afb1-a68f9eb7431b 45945-157 HUMAN PRESCRIPTION DRUG Gablofen baclofen INJECTION INTRATHECAL 20101119 NDA NDA022462 Mallinckrodt Inc (Brand Pharmaceuticals) BACLOFEN 2000 ug/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 45963-125_888843f6-142a-4e1a-92e7-946e07ed30de 45963-125 HUMAN OTC DRUG Infants Ibuprofen concetrated ibuprofen SUSPENSION ORAL 20100520 ANDA ANDA079058 Actavis Inc. IBUPROFEN 50 mg/1.25mL 45963-152_7683c07c-18cf-4cd4-ab8b-a26989885634 45963-152 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20120529 ANDA ANDA077899 Actavis Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 45963-293_207ccf79-1327-46d0-8a42-70e6179171e3 45963-293 HUMAN PRESCRIPTION DRUG Trimipramine maleate Trimipramine maleate CAPSULE ORAL 20111121 ANDA ANDA077361 Actavis Inc. TRIMIPRAMINE MALEATE 25 mg/1 Tricyclic Antidepressant [EPC] 45963-294_207ccf79-1327-46d0-8a42-70e6179171e3 45963-294 HUMAN PRESCRIPTION DRUG Trimipramine maleate Trimipramine maleate CAPSULE ORAL 20111121 ANDA ANDA077361 Actavis Inc. TRIMIPRAMINE MALEATE 50 mg/1 Tricyclic Antidepressant [EPC] 45963-295_207ccf79-1327-46d0-8a42-70e6179171e3 45963-295 HUMAN PRESCRIPTION DRUG Trimipramine maleate Trimipramine maleate CAPSULE ORAL 20111021 ANDA ANDA077361 Actavis Inc. TRIMIPRAMINE MALEATE 100 mg/1 Tricyclic Antidepressant [EPC] 45963-303_b8ee0dca-fc9b-4a0f-abff-5bb2348c6ead 45963-303 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140619 ANDA ANDA203901 Actavis Pharma, Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 45963-304_b8ee0dca-fc9b-4a0f-abff-5bb2348c6ead 45963-304 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140619 ANDA ANDA203901 Actavis Pharma, Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 45963-305_b8ee0dca-fc9b-4a0f-abff-5bb2348c6ead 45963-305 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140619 ANDA ANDA203901 Actavis Pharma, Inc. DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 45963-327_e1f208ca-7f3d-496d-ada7-7d936ea43807 45963-327 HUMAN PRESCRIPTION DRUG PHENDIMETRAZINE TARTRATE Phendimetrazine Tartrate TABLET ORAL 20121120 ANDA ANDA040762 Actavis, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 45963-341_5fb2cfee-ec89-4ffe-95f7-a04f0eae65e9 45963-341 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20060509 ANDA ANDA074430 Actavis Pharma, Inc. DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 45963-342_5fb2cfee-ec89-4ffe-95f7-a04f0eae65e9 45963-342 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20060501 ANDA ANDA071601 Actavis Pharma, Inc. DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 45963-343_5fb2cfee-ec89-4ffe-95f7-a04f0eae65e9 45963-343 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20060604 ANDA ANDA071588 Actavis Pharma, Inc. DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 45963-344_5fb2cfee-ec89-4ffe-95f7-a04f0eae65e9 45963-344 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20060508 ANDA ANDA071602 Actavis Pharma, Inc. DESIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 45963-345_5fb2cfee-ec89-4ffe-95f7-a04f0eae65e9 45963-345 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20060719 ANDA ANDA071766 Actavis Pharma, Inc. DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 45963-346_5fb2cfee-ec89-4ffe-95f7-a04f0eae65e9 45963-346 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20060509 ANDA ANDA074430 Actavis Pharma, Inc. DESIPRAMINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 45963-412_e3717ad1-2c17-4f4d-afc0-ad6b68595323 45963-412 HUMAN PRESCRIPTION DRUG Hydrocortisone and Acetic Acid Hydrocortisone and Acetic Acid SOLUTION AURICULAR (OTIC) 20090629 ANDA ANDA087143 Actavis Inc. ACETIC ACID; HYDROCORTISONE 2.41; 3.15 g/100mL; g/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 45963-438_47f6d61a-1abd-45ef-b299-94a10a27bb58 45963-438 HUMAN PRESCRIPTION DRUG Enulose Lactulose SOLUTION ORAL; RECTAL 20110228 ANDA ANDA090502 Actavis Inc. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 45963-439_16ed7f67-42ec-4e5e-bfc4-8e7e31eb9c50 45963-439 HUMAN PRESCRIPTION DRUG Constulose Lactulose SOLUTION ORAL 20110228 ANDA ANDA090503 Actavis Inc. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 45963-460_16cb41cf-11ea-4a42-a396-a8572ccaba04 45963-460 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20121218 ANDA ANDA201921 Actavis Inc LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 45963-461_16cb41cf-11ea-4a42-a396-a8572ccaba04 45963-461 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20121218 ANDA ANDA201921 Actavis Inc LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 45963-500_391fb235-2248-4919-b20a-e9f4456a9e63 45963-500 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20070328 ANDA ANDA077914 Actavis Pharma, Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 45963-538_4a9c8930-383b-4d5a-a36e-88409b857d41 45963-538 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070727 ANDA ANDA077851 Actavis Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 45963-539_4a9c8930-383b-4d5a-a36e-88409b857d41 45963-539 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070727 ANDA ANDA077851 Actavis Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 45963-555_e3189f16-0d74-4422-89a6-9427d71130fd 45963-555 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140317 ANDA ANDA075350 Actavis Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 45963-556_e3189f16-0d74-4422-89a6-9427d71130fd 45963-556 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 Actavis Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 45963-557_e3189f16-0d74-4422-89a6-9427d71130fd 45963-557 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140317 ANDA ANDA075350 Actavis Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 45963-558_2d7fd50b-1c8b-4f87-b67e-17df25f828c5 45963-558 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET, FILM COATED ORAL 20110425 ANDA ANDA090370 Actavis Pharma, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 45963-559_2d7fd50b-1c8b-4f87-b67e-17df25f828c5 45963-559 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET, FILM COATED ORAL 20110425 ANDA ANDA090370 Actavis Pharma, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 45963-561_8020b243-6d85-4443-97bf-51a032cee058 45963-561 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA090551 Actavis Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 45963-569_5d44f837-7c3d-40e8-b33b-5abd82fcaab7 45963-569 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110208 ANDA ANDA090797 Actavis Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 45963-570_5d44f837-7c3d-40e8-b33b-5abd82fcaab7 45963-570 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110208 ANDA ANDA090797 Actavis Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 45963-600_84578df0-d7b4-4c1c-ad27-5b40a7279d9c 45963-600 HUMAN PRESCRIPTION DRUG FINASTERIDE FINASTERIDE TABLET, FILM COATED ORAL 20131105 ANDA ANDA078371 Actavis Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 45963-633_d4c3c78a-3959-434a-857e-1161becbd0d5 45963-633 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 Actavis Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 45963-634_d4c3c78a-3959-434a-857e-1161becbd0d5 45963-634 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 Actavis Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 45963-635_d4c3c78a-3959-434a-857e-1161becbd0d5 45963-635 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 Actavis Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 45963-733_a75d920d-f1d1-4bc2-875b-688e57aba6f1 45963-733 HUMAN PRESCRIPTION DRUG Doxorubicin hydrochloride Doxorubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 20141101 ANDA ANDA203622 Actavis Pharma, Inc. DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 45963-734_26da17c5-ff40-4ac5-8aa1-c7363e6fca4d 45963-734 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140901 NDA NDA203551 Actavis Pharma, Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 45963-743_a74f4bb3-7b0c-4707-9853-b434611fc20e 45963-743 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20140902 ANDA ANDA040456 Actavis Pharma, Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 45963-745_a74f4bb3-7b0c-4707-9853-b434611fc20e 45963-745 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20140331 ANDA ANDA040456 Actavis Pharma, Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 45963-748_a74f4bb3-7b0c-4707-9853-b434611fc20e 45963-748 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20140331 ANDA ANDA040456 Actavis Pharma, Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 45963-749_a74f4bb3-7b0c-4707-9853-b434611fc20e 45963-749 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20140331 ANDA ANDA040456 Actavis Pharma, Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 45963-753_6ad1e10f-1069-4960-96a2-48ddf6662d36 45963-753 HUMAN PRESCRIPTION DRUG Glyburide (micronized) and Metformin Hydrochloride Glyburide (micronized) and Metformin Hydrochloride TABLET ORAL 20110622 ANDA ANDA076716 Actavis Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 45963-806_12e15a9a-bb04-4f45-adb7-a1318ad73764 45963-806 HUMAN PRESCRIPTION DRUG Dexmethylphenidate hydrochloride Dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141111 ANDA ANDA079108 Actavis Pharma, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 45963-811_fd1ac84d-ddca-491c-bb16-05ac5ab23a84 45963-811 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20131217 ANDA ANDA202572 Actavis Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 45963-833_12e15a9a-bb04-4f45-adb7-a1318ad73764 45963-833 HUMAN PRESCRIPTION DRUG Dexmethylphenidate hydrochloride Dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140224 ANDA ANDA079108 Actavis Pharma, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 45984-0001_7a14f2f0-e8bb-4850-91ea-2aa3f7a0b943 45984-0001 HUMAN PRESCRIPTION DRUG neobryxol Neb Argentum nitricum, Arsenicum iodatum, Bryonia, Carbo vegetabiles, Conium maculatum, Kali bichromicum, Lachesis mutus, Lycopodium, Nux vomica and Viscum album LIQUID NASAL 20120104 UNAPPROVED HOMEOPATHIC Bryomed Inc ACTIVATED CHARCOAL; ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; CONIUM MACULATUM FLOWERING TOP; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; POTASSIUM DICHROMATE; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; VISCUM ALBUM WHOLE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 45984-0002_ea6128bb-29d8-4373-b6be-e1f24a6efb13 45984-0002 HUMAN PRESCRIPTION DRUG NeobryXol Forte Asterias rubens, Bryonia, Conium maculatum, Galium aparine, Hoang-nan, Lachesis mutus, Nux vomica, Ova tosta, Sepia and Viscum album LIQUID ORAL 20120404 UNAPPROVED HOMEOPATHIC Bryomed Inc. ASTERIAS RUBENS; BRYONIA ALBA ROOT; CONIUM MACULATUM FLOWERING TOP; EGG SHELL, COOKED; GALIUM APARINE; LACHESIS MUTA VENOM; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; STRYCHNOS WALLICHIANA BARK; VISCUM ALBUM WHOLE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 45984-0003_f4210529-a4e4-44ab-abd7-9421921e4c2c 45984-0003 HUMAN PRESCRIPTION DRUG Neobryxol Ultra Asterias rubens, Bryonia alba, Conium maculatum Galium aparine, Hoang-nan, Lachesis, Ledum palustre, Nux Vomica, Ova tosta and Viscum album. LIQUID ORAL 20120404 UNAPPROVED HOMEOPATHIC Bryomed Inc. ASTERIAS RUBENS; BRYONIA ALBA ROOT; CONIUM MACULATUM FLOWERING TOP; EGG SHELL, COOKED; GALIUM APARINE; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; STRYCHNOS NUX-VOMICA SEED; STRYCHNOS WALLICHIANA BARK; VISCUM ALBUM WHOLE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 45984-0004_beb04235-f791-4104-9ce7-ae36989337a2 45984-0004 HUMAN PRESCRIPTION DRUG Oncospray Blue Homepathic RX LIQUID ORAL 20120309 UNAPPROVED HOMEOPATHIC Bryomed Inc. ALOE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; MERCURY; PHOSPHORUS; SILICON DIOXIDE; VISCUM ALBUM WHOLE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL 45985-646_7adea54e-010d-4ad5-a605-c717239b0ada 45985-646 HUMAN PRESCRIPTION DRUG UTA Methenamine, Sodium Phosphate Monobasic, Phenyl Salicylate, Methylene Blue, Hyoscyamine Sulfate CAPSULE ORAL 20020801 UNAPPROVED DRUG OTHER STEWART-JACKSON PHARMACAL, INC HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC .12; 120; 10; 36; 40.8 mg/206.92mg; mg/206.92mg; mg/206.92mg; mg/206.92mg; mg/206.92mg 46006-002_761b6fe0-8816-45fb-9629-84cb49af67a6 46006-002 HUMAN OTC DRUG elave Age Delay Daily Lip Defence SPF20 Octinoxate, Zinc Oxide OINTMENT TOPICAL 20111220 OTC MONOGRAPH NOT FINAL part352 Ovelle Ltd OCTINOXATE; ZINC OXIDE 1.125; .6 mL/15mL; mL/15mL 46007-101_105ffc42-36be-489a-bd18-b31b2194b4cf 46007-101 HUMAN OTC DRUG ACNE AND OIL CONTROL SALICYLIC ACID GEL TOPICAL 20120419 OTC MONOGRAPH FINAL part333D Skin Authority LLC SALICYLIC ACID 2 g/100mL 46007-201_bfc27b05-aab0-4c82-a43a-382d39a973a8 46007-201 HUMAN OTC DRUG AGE DEFYING HYDRATING SUNSCREEN SPF 30 AVOBENZONE OCTINOXATE OCTISALATE OXYBENZONE HOMOSALATE OCTOCRYLENE LOTION TOPICAL 20120419 OTC MONOGRAPH FINAL part352 Skin Authority LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7; 7.5; 5; 3; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 46007-202_8181d950-e6c5-4431-a4e0-ef6c80003bb6 46007-202 HUMAN OTC DRUG AGE DEFYING MOISTURIZER SPF 18 AVOBENZONE OCTINOXATE OCTISALATE OXYBENZONE LOTION TOPICAL 20120419 OTC MONOGRAPH FINAL part352 Skin Authority LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL 46007-203_0f90b87f-9aba-456f-b785-1a6b0e311f09 46007-203 HUMAN OTC DRUG SUNSCREEN MOISTURIZER SPF 30 AVOBENZONE OCTINOXATE OCTISALATE OXYBENZONE HOMOSALATE OCTOCRYLENE LOTION TOPICAL 20120419 OTC MONOGRAPH FINAL part352 Skin Authority LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7; 7.5; 5; 3; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 46007-301_d29a562a-a775-46e7-9e5a-09a087e41a40 46007-301 HUMAN OTC DRUG HYPERPIGMENTATION TREATMENT HYDROQUINONE LOTION TOPICAL 20120419 OTC MONOGRAPH FINAL part358A Skin Authority LLC HYDROQUINONE 2 g/100mL 46011-1234_76400985-539e-4b5e-a4e6-26e6100cf15d 46011-1234 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090204 UNAPPROVED MEDICAL GAS Kadence Healthcare, Inc. OXYGEN 99 L/100L 46014-0501_8b66b3f1-06d1-4afa-8bfc-af6c19fcd649 46014-0501 HUMAN PRESCRIPTION DRUG Hepsera Adefovir Dipivoxil TABLET ORAL 20020920 NDA NDA021449 Excella GmbH ADEFOVIR DIPIVOXIL 10 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 46014-0601_1920b87b-ac14-4b51-ae82-9ccf51f1b00e 46014-0601 HUMAN PRESCRIPTION DRUG Emtriva emtricitabine CAPSULE ORAL 20030702 NDA NDA021500 Excella GmbH EMTRICITABINE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 46017-012_587358ac-e28c-11e3-8b68-0800200c9a66 46017-012 HUMAN OTC DRUG Vivarin Caffeine TABLET ORAL 20140615 OTC MONOGRAPH FINAL part340 Meda Consumer Healthcare Inc. CAFFEINE 200 mg/1 46017-018_d686c0c0-d232-11e3-9c1a-0800200c9a66 46017-018 HUMAN OTC DRUG Vivarin Caffeine TABLET ORAL 20120115 OTC MONOGRAPH FINAL part340 Meda Consumer Healthcare Inc. CAFFEINE 200 mg/1 46017-020_8ed2df71-fdb1-11e3-a3ac-0800200c9a66 46017-020 HUMAN OTC DRUG Contac Cold and Flu Day Night acetaminophen and phenylephrine hydrochloride/ acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride KIT ORAL 20140701 OTC MONOGRAPH FINAL part341 Meda Consumer Healthcare Inc. 46017-021_758605b0-fd52-11e3-a3ac-0800200c9a66 46017-021 HUMAN OTC DRUG Contac Cold and Flu Day acetaminophen and phenylephrine hydrochloride TABLET ORAL 20140701 OTC MONOGRAPH FINAL part341 Meda Consumer Healthcare Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 46017-022_56102400-fd56-11e3-a3ac-0800200c9a66 46017-022 HUMAN OTC DRUG Contac Cold and Flu Night acetaminophen, Chlorpheniramine maleate, and phenylephrine hydrochloride TABLET ORAL 20140701 OTC MONOGRAPH FINAL part341 Meda Consumer Healthcare Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 500; 2; 5 mg/1; mg/1; mg/1 46017-023_4c55f3f5-c4cf-11df-851a-0800200c9a66 46017-023 HUMAN OTC DRUG Contac Cold and Flu Maximum Strength acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride TABLET ORAL 20110715 OTC MONOGRAPH FINAL part341 Meda Consumer Healthcare Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 500; 2; 5 mg/1; mg/1; mg/1 46017-024_d68699b0-d232-11e3-9c1a-0800200c9a66 46017-024 HUMAN OTC DRUG Contac Cold and Flu Day acetaminophen and phenylephrine hydrochloride TABLET ORAL 20110701 OTC MONOGRAPH FINAL part341 Meda Consumer Healthcare Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 46017-026_9e440091-0995-11e2-892e-0800200c9a66 46017-026 HUMAN OTC DRUG Contac Cold and Flu Cooling Relief acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate liquid LIQUID ORAL 20120715 OTC MONOGRAPH FINAL part341 Meda Consumer Healthcare Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 46026-983_966433db-bb0b-475c-afb8-a0996ce4b516 46026-983 HUMAN PRESCRIPTION DRUG ISTODAX romidepsin KIT 20100104 NDA NDA022393 Gloucester Pharmaceuticals, Inc. 46028-208_e4297e7a-719e-46d3-b18d-30f4d5d4208a 46028-208 VACCINE Menveo Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine KIT INTRAMUSCULAR 20100219 BLA BLA125300 Novartis Vaccines and Diagnostics s.r.l. 46084-012_113f7b27-dc67-473f-80ed-275c08320439 46084-012 HUMAN OTC DRUG APTRIZINE 24-HOUR ALL DAY ALLERGY CETIRIZINE HYDROCHLORIDE TABLET ORAL 20130221 ANDA ANDA019835 A P J Laboratories Limited CETIRIZINE HYDROCHLORIDE 10 mg/1 46084-021_496c0fce-ed16-49f1-89fd-946140bcdedc 46084-021 HUMAN OTC DRUG APROFEN REGULAR STRENGTH IBUPROFEN TABLET ORAL 20130221 OTC MONOGRAPH FINAL part343 A P J Laboratories Limited IBUPROFEN 200 mg/1 46084-031_cbc1050f-9b82-4e4c-aa84-78ba062e75b0 46084-031 HUMAN OTC DRUG APTIDINE 75 RANITIDINE HYDROCHLORIDE TABLET ORAL 20130301 ANDA ANDA075132 A P J Laboratories Limited RANITIDINE HYDROCHLORIDE 75 mg/1 46084-041_50d6dad6-66cb-40bf-9ae0-70dd6403d46d 46084-041 HUMAN OTC DRUG APHENAP DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20130301 OTC MONOGRAPH FINAL part341 A P J Laboratories Limited DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 46084-051_b4133ea4-5e75-46d7-80b4-e7350c8ce234 46084-051 HUMAN OTC DRUG GUAAP GUAIFENESIN LIQUID ORAL 20130301 OTC MONOGRAPH FINAL part341 A P J Laboratories Limited GUAIFENESIN 100 mg/5mL 46084-061_5d9790ab-2120-4b04-a87c-d27e1e0640a2 46084-061 HUMAN OTC DRUG APINOPHEN EXTRA STRENGTH ACETAMINOPHEN TABLET ORAL 20130301 OTC MONOGRAPH NOT FINAL part343 A P J Laboratories Limited ACETAMINOPHEN 500 mg/1 46084-071_8747131c-4c0b-4306-8bd9-b29cefb71296 46084-071 HUMAN OTC DRUG APCAL Calcium Carbonate and Vitamin D3 TABLET ORAL 20130301 OTC MONOGRAPH FINAL part331 A P J Laboratories limited CALCIUM CARBONATE; CHOLECALCIFEROL 1250; 250 mg/1; [iU]/1 46084-081_8ef19bfe-6e70-4aed-979b-274315278c63 46084-081 HUMAN OTC DRUG APTRIMAZOLE 1.0% ANTIFUNGAL CREAM CLOTRIMAZOLE CREAM TOPICAL 20130427 OTC MONOGRAPH FINAL part333C A P J Laboratories Limited CLOTRIMAZOLE 1 g/100g 46084-091_14d51b10-696d-4626-bb3b-143cde538b2f 46084-091 HUMAN OTC DRUG IBUPROFEN COLD AND SINUS A P J IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED ORAL 20130601 ANDA ANDA074567 A P J Laboratories Limited IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 46084-101_529b0e8e-4f74-4d96-b9dc-c57ba66162d3 46084-101 HUMAN OTC DRUG ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20130606 OTC MONOGRAPH FINAL part341 A P J Laboratories Limited ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 46084-111_a0c485a4-d719-42e7-8764-459756dfdae3 46084-111 HUMAN OTC DRUG APJ HEMORRHOIDAL PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM OINTMENT TOPICAL 20130701 OTC MONOGRAPH FINAL part346 A P J Laboratories Limited MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 720; 2.55 mg/g; mg/g; mg/g 46084-121_c75e18ea-fbbe-477e-a961-6ce6d1954cab 46084-121 HUMAN OTC DRUG DAYTIME NIGHTTIME COLD/FLU RELIEF A P J DAYTIME NIGHTTIME COLD/FLU RELIEF KIT 20130601 OTC MONOGRAPH FINAL part341 A P J Laboratories Limited 46088-010_f74dc486-5967-427c-aa71-166f11574950 46088-010 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20080101 UNAPPROVED MEDICAL GAS Purepoint, Inc OXYGEN 99 L/100L 46122-003_37732ff9-693e-44ec-a4c0-bc920d700389 46122-003 HUMAN OTC DRUG Good Neighbor Pharmacy Pain Relief Rapid Release Extra Strength Acetaminophen TABLET, COATED ORAL 20090810 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 500 mg/1 46122-004_72e52711-20e3-40d2-8e1e-f59cd8641c39 46122-004 HUMAN OTC DRUG Good Neighbor Pharmacy Day Time Acetaminophen, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20091224 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 46122-006_aabf1e1a-1c8c-42e8-9dad-cf9b3addf93e 46122-006 HUMAN OTC DRUG Good Neighbor Pharmacy Night Time Acetaminophen, Doxylamine Succinate, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20091207 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 46122-008_4471cf9d-2b3f-492b-b2a9-7121b2750aa6 46122-008 HUMAN OTC DRUG Good Neighbor Pharmacy Night Time acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090622 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 46122-010_46bb0d99-489d-49bb-bdc6-4cf668e8ac61 46122-010 HUMAN OTC DRUG Good Neighbor Pharmacy Ibuprofen Ibuprofen TABLET ORAL 20091019 ANDA ANDA076359 Amerisource Bergen IBUPROFEN 100 mg/1 46122-013_95e3b870-6f78-4ace-83de-da19b6d7c087 46122-013 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY DIAPER RASH CREAMY ZINC OXIDE OINTMENT TOPICAL 20120501 OTC MONOGRAPH FINAL part347 AMERISOURCE BERGEN ZINC OXIDE .1 g/g 46122-014_4a0a5783-6eb2-41f4-b9e7-1f71489011dd 46122-014 HUMAN OTC DRUG Good Neighbor Pharmacy ClearLax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091019 ANDA ANDA090685 Amerisource Bergen POLYETHYLENE GLYCOL 3350 17 g/17g 46122-017_5930ec18-554d-4bb0-9387-ce4010aa71f4 46122-017 HUMAN OTC DRUG Good Neighbor Pharmacy tussin dm max adult Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20100907 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 46122-018_e0aee839-06bb-4398-aa39-eb623dbfca37 46122-018 HUMAN OTC DRUG GNP Lubricant Eye Polyethylene Glycol 400 SOLUTION/ DROPS OPHTHALMIC 20130630 OTC MONOGRAPH FINAL part349 Amerisource Bergen POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mg/mg; mg/mg 46122-019_f520f6c7-cc07-482d-8047-ded05dc7db2d 46122-019 HUMAN OTC DRUG good neighbor pharmacy pain relief Acetaminophen SUSPENSION ORAL 20110201 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL 46122-020_37155b8d-d193-4f3e-8cd6-a904d11854f8 46122-020 HUMAN OTC DRUG Good Neighbor Pharmacy Allergy childrens all day cetirizine Hydrochloride LIQUID ORAL 20101029 ANDA ANDA090254 Amerisource Bergen CETIRIZINE HYDROCHLORIDE 5 mg/5mL 46122-021_377332f1-5a4d-469b-8f38-00ca81a53c37 46122-021 HUMAN OTC DRUG Pre Menstrual relief maximum strength ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE TABLET ORAL 20110107 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 46122-022_c49f1d75-1d2e-4bb5-96f1-a45c7cf51a75 46122-022 HUMAN OTC DRUG good neighbor pharmacy flu and severe cold and cough Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20110204 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 46122-023_450a3afd-fcab-4770-b7f1-fad207eba67b 46122-023 HUMAN OTC DRUG good neighbor pharmacy itchy eye Ketotifen SOLUTION OPHTHALMIC 20101007 ANDA ANDA077958 Amerisource Bergen KETOTIFEN FUMARATE .25 mg/mL 46122-026_f44ad51b-82e8-4f53-9a98-ad156b1ce2bb 46122-026 HUMAN OTC DRUG good neighbor pharmacy pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 19950908 OTC MONOGRAPH FINAL part338 Amerisource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 46122-027_c0faf439-1431-4300-9fcb-3a8128e613bc 46122-027 HUMAN OTC DRUG good neighbor pharmacy miconazole 1 Miconazole nitrate KIT 20100611 ANDA ANDA079114 Amerisource Bergen 46122-028_60ba6ae3-4061-4dc3-a93b-ec6b5d8cfd5b 46122-028 HUMAN OTC DRUG Good Neighbor Pharmacy mucus er Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130319 ANDA ANDA078912 Amerisource Bergen GUAIFENESIN 600 mg/1 46122-029_2a30e8e8-f116-4c11-9085-2f1c2ff16e20 46122-029 HUMAN OTC DRUG good neighbor pharmacy omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080227 NDA NDA022032 Amerisource Bergen OMEPRAZOLE 20 mg/1 46122-030_d25d611e-ad01-4212-8f47-ec07cbcc43d0 46122-030 HUMAN OTC DRUG Good Neighbor Pain Relief Benzocaine LIQUID ORAL 20080801 OTC MONOGRAPH NOT FINAL part356 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) BENZOCAINE 200 mg/mL 46122-031_63b26d3e-760e-4177-8efc-8ae4750412bb 46122-031 HUMAN OTC DRUG Good Neighbor Pharmacy Pain Relief Infants Acetaminophen SUSPENSION/ DROPS ORAL 20110407 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 80 mg/.8mL 46122-032_12b4e960-0d33-478f-aaa2-208a3e80beaf 46122-032 HUMAN OTC DRUG good neighbor pharmacy day time Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20101209 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/15mL; mg/15mL 46122-036_1d69861b-435a-486e-8477-0d0613c0b6f6 46122-036 HUMAN OTC DRUG Childrens Plus Multi-Symptom Cold Grape with PE Childrens Tylenol Plus Multi-Symptom Cold SUSPENSION ORAL 20120101 OTC MONOGRAPH FINAL part341 Good Neighbor Pharmacy ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 46122-037_5d0a9198-0226-4b02-97b4-af1dd5233d6b 46122-037 HUMAN OTC DRUG good neighbor pharmacy flu and severe cold and cough nighttime Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20110210 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 46122-038_ca3fe06c-a37e-4f7d-99a3-031f36d88f6f 46122-038 HUMAN OTC DRUG Good Neighbor Pharmacy Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20110106 NDA NDA021920 Amerisource Bergen NAPROXEN SODIUM 220 mg/1 46122-040_b65da823-00a0-43f7-8b2c-13971814959b 46122-040 HUMAN OTC DRUG good neighbor pharmacy allergy relief fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110622 ANDA ANDA076447 Amerisource Bergen FEXOFENADINE HYDROCHLORIDE 180 mg/1 46122-041_0750ee3a-5a4f-4b7f-83a5-256f5b7e6eaf 46122-041 HUMAN OTC DRUG good neighbor pharmacy acid control 150 Ranitidine TABLET, FILM COATED ORAL 20111004 ANDA ANDA091429 Amerisource Bergen RANITIDINE HYDROCHLORIDE 150 mg/1 46122-042_e9818828-56f7-4b74-a7f4-55dbaf6ba61e 46122-042 HUMAN OTC DRUG good neighbor pharmacy pain and fever Acetaminophen SUSPENSION ORAL 20110828 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL 46122-043_1e91a32c-524e-44ab-9553-b3e761dc3944 46122-043 HUMAN OTC DRUG Good Neighbor Pharmacy Alcohol Antiseptic Skin Cleanser Isopropyl Alcohol SWAB TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333A Amerisouce Bergen ISOPROPYL ALCOHOL 70 mL/100mL 46122-044_f0abc596-7093-4a63-b3e5-d507c7085ba1 46122-044 HUMAN OTC DRUG GNP Acne Treatment Benzoyl Peroxide CREAM TOPICAL 20130630 OTC MONOGRAPH FINAL part333D Amerisource Bergen BENZOYL PEROXIDE 10 g/100g 46122-050_adb8412e-e577-4fe1-8891-207e47df1e06 46122-050 HUMAN OTC DRUG Childrens Acetaminophen Cherry Childrens Tylenol SUSPENSION ORAL 20120101 OTC MONOGRAPH NOT FINAL part343 Good Neighbor Pharmacy ACETAMINOPHEN 160 mg/5mL 46122-054_6a40bc88-e271-484b-a860-3b52471da070 46122-054 HUMAN OTC DRUG GNP Hygienic Cleansing Pads Witch Hazel SOLUTION RECTAL; TOPICAL 20130630 OTC MONOGRAPH FINAL part346 Amerisource Bergen WITCH HAZEL .5 mg/mg 46122-055_1b91f562-e8d2-42e9-9bea-ea24ec7234bf 46122-055 HUMAN OTC DRUG GNP Medicated Wipes Witch Hazel SOLUTION RECTAL; TOPICAL 20130630 OTC MONOGRAPH FINAL part346 Amerisource Bergen WITCH HAZEL .5 mg/mg 46122-056_7601d3c9-0fdb-422a-9d3b-603bb26c4866 46122-056 HUMAN OTC DRUG good neighbor pharmacy Pain and Fever Acetaminophen LIQUID ORAL 20110828 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL 46122-057_916c59ed-07ea-4e0b-a6c0-de357d78ee0e 46122-057 HUMAN OTC DRUG Good Neighbor Pharmacy TabTussin Guaifenesin TABLET ORAL 20110926 OTC MONOGRAPH FINAL part341 AmerisourceBergen Drug Corp GUAIFENESIN 400 mg/1 46122-058_3f97cc9d-4bdf-4862-8bcd-ff2f0ef62d2b 46122-058 HUMAN OTC DRUG Good Neighbor Pharmacy Tab Tussin DM DMTDM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 AmerisourceBergen Drug Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 46122-062_4fef2c61-8322-49ae-8bec-521fe9eb696b 46122-062 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Amerisource Bergen ACETAMINOPHEN 650 mg/1 46122-101_b1ebbc59-6846-4cf1-b4a7-3429ee26652c 46122-101 HUMAN OTC DRUG All Day Allergy Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Amerisource Bergen CETIRIZINE HYDROCHLORIDE 5 mg/5mL 46122-103_123321d5-bbda-4923-b9a4-7578521ec8f0 46122-103 HUMAN OTC DRUG Good Neighbor Pharmacy Hemorrhoidal Mineral Oil OINTMENT TOPICAL 20130630 OTC MONOGRAPH FINAL part346 Amerisource Bergen MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 74.9; 2.5 mg/100g; mg/100g; mg/100g 46122-104_e1f67e3f-d08e-4ec8-8b73-fb659154571d 46122-104 HUMAN OTC DRUG Headache relief Extra Strength Acetaminophen, Aspirin and Caffeine TABLET ORAL 20120415 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 46122-105_43b1148c-4f10-4b83-9f76-99a21c6a2e21 46122-105 HUMAN OTC DRUG good neighbor pharmacy childrens pain relief Acetaminophen LIQUID ORAL 19950922 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL 46122-106_329b4089-f9b9-4419-b8e0-f3ef00ba301b 46122-106 HUMAN OTC DRUG good neighbor pharmacy pain relief acetaminophen LIQUID ORAL 20120328 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL 46122-107_ebb45488-84f7-4d53-b8f1-0c5e06b2a951 46122-107 HUMAN OTC DRUG Good Neighbor Pharmacy Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120531 ANDA ANDA202319 Amerisource Bergen LANSOPRAZOLE 15 mg/1 46122-108_cce3b28b-7761-4045-a631-380ed8e529c2 46122-108 HUMAN OTC DRUG good neighbor pharmacy lice treatment Permethrin LOTION TOPICAL 20120307 ANDA ANDA076090 Amerisource Bergen PERMETHRIN 1 mg/100mL 46122-109_ab2d358a-809c-435d-93ce-f36b55aa7880 46122-109 HUMAN OTC DRUG good neighbor pharmacy loratadine d Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120323 ANDA ANDA076050 Amerisource Bergen LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 46122-110_7189a96a-2384-40c5-aae5-6b5205ac2f3b 46122-110 HUMAN OTC DRUG good neighbor pharmacy childrens ibuprofen Ibuprofen SUSPENSION ORAL 20020402 ANDA ANDA074937 Amerisource Bergen IBUPROFEN 100 mg/5mL 46122-111_541d7244-43ad-4624-b468-a7fb53604c38 46122-111 HUMAN OTC DRUG good neighbor pharmacy Loperamide hydrochloride loperamide HCl LIQUID ORAL 20120217 ANDA ANDA091292 Amerisource Bergen LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 46122-116_4d92cdaa-838a-4032-a837-0843bf035481 46122-116 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY CAPSAICIN CAPSAICIN CREAM TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part348 AMERISOURCE BERGEN CAPSAICIN .1 g/100g 46122-118_08245596-67a0-44d0-8fc1-6cee506bdef2 46122-118 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY ZINC OXIDE ZINC OXIDE OINTMENT TOPICAL 20120401 OTC MONOGRAPH FINAL part347 AMERISOURCE BERGEN ZINC OXIDE 20 g/100g 46122-125_a50e73ca-ef48-41d2-ae52-54ebf6ae50c9 46122-125 HUMAN OTC DRUG good neighbor pharmacy hair regrowth treatment for men Minoxidil AEROSOL, FOAM TOPICAL 20120302 ANDA ANDA091344 Amerisource Bergen MINOXIDIL 5 g/100g 46122-134_5d5336ca-aa9e-49ed-9bb4-66ee75a4907c 46122-134 HUMAN OTC DRUG good neighbor pharmacy headache pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20000201 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 46122-135_1e906c73-c8a5-426f-b4b3-567bfd724abc 46122-135 HUMAN OTC DRUG Good Neighbor Pharmacy Flu and Sore throat acetaminophen,pheniramine maleate, phenylephrine hydrochloride POWDER, FOR SUSPENSION ORAL 20120531 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/15000mg; mg/15000mg; mg/15000mg 46122-136_480d97c0-7d5e-448b-8085-0904aa42e403 46122-136 HUMAN OTC DRUG good neighbor pharmacy night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110828 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 46122-138_b529416a-1a2c-4aef-8566-a5102c9d6b70 46122-138 HUMAN OTC DRUG good neighbor pharmacy tussin cf max dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20120802 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL 46122-139_b92e5f7b-1096-496e-a03e-d7cd4e40e394 46122-139 HUMAN OTC DRUG good neighbor pharmacy tussin dm max dextromethorphan hbr, guaifenesin SUSPENSION ORAL 20120802 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 46122-140_fd7412ea-a337-49d7-b25e-012e193111b5 46122-140 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Good Neighbor Pharmacy LORATADINE 10 mg/1 46122-141_290def93-d97a-4e52-a823-c8010cab3e2a 46122-141 HUMAN OTC DRUG Good Neighbor Pharmacy Cough DM ER dextromethorphan polistirex SUSPENSION ORAL 20120830 ANDA ANDA091135 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 46122-142_9b6558b9-557e-47c8-a6e7-58b84dd1eff5 46122-142 HUMAN OTC DRUG Good Neighbor Pharmacy Cough DM ER dextromethorphan polistirex SUSPENSION ORAL 20130624 ANDA ANDA091135 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 46122-144_a19e42b2-6663-47c9-bb23-bcdeccf8eb0e 46122-144 HUMAN OTC DRUG good neighbor pharmacy miconazole 3 Miconazole nitrate KIT 20120904 ANDA ANDA076357 Amerisource Bergen 46122-145_3907bb55-3c39-48b7-b905-ab2e8da34b5e 46122-145 HUMAN OTC DRUG good neighbor pharmacy ibuprofen pm Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20120802 ANDA ANDA079113 Amerisource Bergen DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 46122-146_cd202a72-4588-4a96-a02d-9daedcbd3a24 46122-146 HUMAN OTC DRUG Itchy Eye Drops ketotifen fumarate SOLUTION/ DROPS OPHTHALMIC 20131206 ANDA ANDA077958 Amerisource Bergen KETOTIFEN FUMARATE .35 mg/mL 46122-157_95212d4b-7381-4f99-bc9c-c77a952d8742 46122-157 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20090908 OTC MONOGRAPH FINAL part341 AmersourceBergen CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100kg; kg/100kg 46122-158_edba298d-ed0a-4f7e-a1b0-0afff57a1edd 46122-158 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Amerisource Bergen LORATADINE 10 mg/1 46122-161_b8d093e5-e2b6-47bb-8c80-e0e33abfcb38 46122-161 HUMAN OTC DRUG Good Neighbor Pharmacy Sodium Phosphate Enema ENEMA RECTAL 20130301 OTC MONOGRAPH NOT FINAL part334 AMERISOURCEBERGEN DRUG CORPORATION SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 46122-162_f75b3f9a-2d66-44fd-b617-36ab5e16e145 46122-162 HUMAN OTC DRUG Good Neighbor Pharmacy Mineral Oil ENEMA RECTAL 20130301 OTC MONOGRAPH NOT FINAL part334 AMERISOURCEBERGEN DRUG CORPORATION MINERAL OIL 118 mL/118mL 46122-163_e735287e-92a2-4037-8650-e763c6895af9 46122-163 HUMAN OTC DRUG Eye Itch Relief ketotifen fumarate SOLUTION/ DROPS OPHTHALMIC 20131206 ANDA ANDA077958 Amerisource Bergen KETOTIFEN FUMARATE .35 mg/mL 46122-164_8ff17952-4a96-4093-8cca-fee6f443904c 46122-164 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 AmerisourceBergen LORATADINE 5 mg/5mL 46122-165_9c3d7281-59f4-4618-b303-4fc3a3f88f4b 46122-165 HUMAN OTC DRUG good neighbor pharmacy nasal oxymetazoline hydrochloride SPRAY NASAL 19900115 OTC MONOGRAPH FINAL part341 Amerisource Bergen OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 46122-166_a8c0d9b9-de99-4e30-bd0f-18488585dc60 46122-166 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Amerisource Bergen PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 46122-167_75855860-b79d-41e4-80df-be40864823b5 46122-167 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Amerisource Bergen LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 46122-168_5e636ca3-5c52-4c0e-8597-831268ad77f3 46122-168 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100723 ANDA ANDA090283 Amerisource Bergen FAMOTIDINE 20 mg/1 46122-169_80a4c80a-d34f-48d8-8484-f605ad892a25 46122-169 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Amerisource Bergen LOPERAMIDE HYDROCHLORIDE 2 mg/1 46122-170_880665b0-58d2-4d20-b3ad-d0bd2ceacf0f 46122-170 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Amerisource Bergen ACETAMINOPHEN 650 mg/1 46122-171_60b50508-e617-44c6-a253-1cf774f88a1d 46122-171 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20140123 ANDA ANDA078325 Amerisource Bergen NICOTINE 2 mg/1 46122-172_c6067ce8-dd2f-4f4e-90f0-b5355c639763 46122-172 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20140123 ANDA ANDA078326 Amerisource Bergen NICOTINE 4 mg/1 46122-173_5fe15468-9619-475c-aae4-52777a08133a 46122-173 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20130722 ANDA ANDA076775 Amerisource Bergen NICOTINE 2 mg/1 46122-174_8592b340-1cf0-49c6-b540-116d5c3b3bc4 46122-174 HUMAN OTC DRUG good neighbor pharmacy nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050831 ANDA ANDA076789 Amerisource Bergen NICOTINE 4 mg/1 46122-176_e8b5337f-76d8-4470-b426-b45ddd2deaa1 46122-176 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex LOZENGE ORAL 20130802 ANDA ANDA077007 Amerisource Bergen NICOTINE 2 mg/1 46122-177_acf3c585-f19a-48c3-9e53-41c8349d982b 46122-177 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex LOZENGE ORAL 20140319 ANDA ANDA077007 Amerisource Bergen NICOTINE 4 mg/1 46122-178_725a7684-d0b3-467f-bcab-762f52f7d74d 46122-178 HUMAN OTC DRUG pain reliever extra strength Acetaminophen TABLET ORAL 20111108 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 500 mg/1 46122-179_86fa81c8-3fd5-4bd0-99b8-d6b2ec7dc88b 46122-179 HUMAN OTC DRUG Pain Relief PM Extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130423 OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 46122-180_db6a1892-99b9-47e7-8a8c-640fc5f62b66 46122-180 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130315 OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) ASPIRIN 81 mg/1 46122-181_3dfeca9b-6eab-432e-bee0-b7d78faad480 46122-181 HUMAN OTC DRUG Cold and Allergy Maximum Strength Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20110402 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 46122-182_8f4f52e1-db4d-42ee-ab2e-a05c6d637677 46122-182 HUMAN OTC DRUG Aspirin Adult Low Strength Aspirin Aspirin TABLET, COATED ORAL 20110317 OTC MONOGRAPH FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) ASPIRIN 81 mg/1 46122-183_47eb60d9-7647-4cbe-bd5a-efc86474790e 46122-183 HUMAN OTC DRUG Night time cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130225 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 46122-184_5818e817-f2a5-4acd-baa2-98efd15fb558 46122-184 HUMAN OTC DRUG Day time cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130210 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 46122-185_72fd3fd4-7cb2-4057-8ea3-e5dfb1b40bf5 46122-185 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY Hydrogen Peroxide Wipes HYDROGEN PEROXIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen HYDROGEN PEROXIDE 3 g/100g 46122-188_4848f613-6985-40df-9674-13cd889424b7 46122-188 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY Isopropyl Alcohol Wipes ISOPROPYL ALCOHOL LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen ISOPROPYL ALCOHOL 70 g/100g 46122-192_0e3a4653-feb8-460b-abd8-c61ead131710 46122-192 HUMAN OTC DRUG Good neighbor pharmacy mucus relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130624 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 46122-193_d58cbcab-a364-4a19-8a6d-a4fde9cf0838 46122-193 HUMAN OTC DRUG Good Neighbor Pharmacy Mucus Relief Severe Congestion and Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130613 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 46122-194_ffe34340-f3a4-447e-a516-3206c24ebec4 46122-194 HUMAN OTC DRUG Good Neighbor Pharmacy Mucus Relief cold and sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130802 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 46122-195_f9cdf3df-bcc6-4438-96b2-4e284d7b76b6 46122-195 HUMAN OTC DRUG good neighbor pharmacy lubricating plus carboxymethylcellulose sodium SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130517 OTC MONOGRAPH FINAL part349 Amerisource Bergen CARBOXYMETHYLCELLULOSE SODIUM .5 g/100mL 46122-196_d2a3c212-8b2c-4c29-92c6-97421b84386b 46122-196 HUMAN OTC DRUG good neighbor pharmacy congestion relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20140927 ANDA ANDA203200 Amerisource Bergen IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 46122-197_a622259a-7530-4ca8-9eb5-4e02857a28f3 46122-197 HUMAN OTC DRUG Good Neighbor Pharmacy Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130822 ANDA ANDA076518 Amerisource Bergen NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 46122-198_b5e51e1e-980a-4811-9c51-ab5b55b1e572 46122-198 HUMAN OTC DRUG good neighbor pharmacy night time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20111016 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 46122-199_dc31df89-f45d-411f-9740-c586e5fa6211 46122-199 HUMAN OTC DRUG PEG-Phen Lubricant Eye Drops Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20130322 OTC MONOGRAPH FINAL part349 Amerisource Bergen POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL 46122-200_393a4319-d7b8-4181-8ea9-5b8f2d4a6a43 46122-200 HUMAN OTC DRUG CMC Lubricant Eye Drops Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20130322 OTC MONOGRAPH FINAL part349 Amerisource Bergen CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL 46122-201_4a345b8d-7853-42d9-bbd4-42b6a9c6e54e 46122-201 HUMAN OTC DRUG PEG-Phen Ultra Lubricant Eye Drops Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20130322 OTC MONOGRAPH FINAL part349 Amerisource Bergen POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL 46122-202_f506194d-c79f-4001-a651-e21a3f51b9db 46122-202 HUMAN OTC DRUG Lubricant PM Mineral Oil, White Petrolatum OINTMENT OPHTHALMIC 20130501 OTC MONOGRAPH FINAL part349 Amerisource Bergen MINERAL OIL; PETROLATUM 425; 573 mg/g; mg/g 46122-204_84bb0b22-3eba-49aa-a3d7-19d5db901aa6 46122-204 HUMAN OTC DRUG Good Neighbor Pharmacy Sleep Time Diphenhydramine HCl SOLUTION ORAL 20130722 OTC MONOGRAPH FINAL part338 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 46122-205_c70dca82-e80d-43a4-93fc-45fc65638c6b 46122-205 HUMAN OTC DRUG Good Neighbor Pharmacy acid reducer Famotidine TABLET ORAL 20091007 ANDA ANDA075400 Amerisource Bergen FAMOTIDINE 10 mg/1 46122-206_a509ff87-18a7-4f16-ba98-f3b3b55579a1 46122-206 HUMAN OTC DRUG Good Neighbor Pharmacy loratadine d 24 hour Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20030623 ANDA ANDA075706 Amerisource Bergen LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 46122-207_d7904841-2352-42f4-8bc1-9426140ff45c 46122-207 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl CAPSULE, LIQUID FILLED ORAL 20130607 NDA NDA021855 AmerisourceBergen (Good Neighbor Pharmacy) 46122 LOPERAMIDE HYDROCHLORIDE 2 mg/1 46122-208_37118b81-37d3-4448-84ef-5a85c181e6af 46122-208 HUMAN OTC DRUG Good Neighbor Pharmacy Sleep Time Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140130 OTC MONOGRAPH FINAL part338 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 46122-209_a3179ede-58e0-40b9-98ab-21d18e6368d3 46122-209 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20130815 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL 46122-210_268a789b-8f31-4739-9777-523249cac326 46122-210 HUMAN OTC DRUG good neighbor pharmacy childrens pain and fever Acetaminophen SUSPENSION ORAL 19931012 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL 46122-211_6ba153b7-9dc9-4e42-9176-13b3922268bd 46122-211 HUMAN OTC DRUG Good Neighbor Pharmacy childrens pain and fever Acetaminophen SUSPENSION ORAL 19980312 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL 46122-212_4320895a-4f9e-4ebd-bffa-0bc9a923d22c 46122-212 HUMAN OTC DRUG good neighbor pharmacy childrens pain and fever Acetaminophen SUSPENSION ORAL 20110201 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL 46122-213_26b587cf-cbf8-46f9-a0da-6f56e0aa8e3e 46122-213 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Pain and Fever Acetaminophen LIQUID ORAL 20131208 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL 46122-214_45f64a75-6d7b-47f3-a9f2-d15afa967b5c 46122-214 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20140225 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL 46122-215_90bf54f0-8db2-4ed2-80ac-6ee69ad30994 46122-215 HUMAN OTC DRUG Good Neighbor Pharmacy Night Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120720 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 46122-217_a6470b0d-7b8a-4349-8985-2c8b9750a6f4 46122-217 HUMAN OTC DRUG Mucus Relief Cold, Flu and Sore Throat Maximum Strength Mucinex Cold, Flu and Sore Throat Maximum Strength LIQUID ORAL 20131104 OTC MONOGRAPH FINAL part341 Good Neighbor Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL 46122-218_c6172e70-b0f6-416c-a179-004c58247f44 46122-218 HUMAN OTC DRUG Mucus Relief DM Max Maximum Strength Mucinex DM Max Maximum Strength LIQUID ORAL 20131025 OTC MONOGRAPH FINAL part341 Good Neighbor Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL 46122-219_e4565f15-7bf1-48f3-bf5f-bb134e68c99c 46122-219 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Mucinex Congestion and Cough Maximum Strength LIQUID ORAL 20131104 OTC MONOGRAPH FINAL part341 Good Neighbor Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL 46122-223_ace6f559-73e4-4853-a71f-5d3b7cb96031 46122-223 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130906 ANDA ANDA201745 Amerisource Bergen RANITIDINE HYDROCHLORIDE 75 mg/1 46122-224_0e3080d6-b5cf-47ad-85fa-07c078474097 46122-224 HUMAN OTC DRUG Good Neighbor Pharmacy Acid Control 150 Ranitidine TABLET, FILM COATED ORAL 20080219 ANDA ANDA091429 Amerisource Bergen RANITIDINE HYDROCHLORIDE 150 mg/1 46122-231_c930f949-4836-4e19-9ea8-3f474b3810d7 46122-231 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130730 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good Neighbor Pharmacy) 46122 DOCUSATE SODIUM 100 mg/1 46122-232_db8acaff-2e0b-4b8a-86c2-a1882f0fbcbe 46122-232 HUMAN OTC DRUG Good Neighbor Pharmacy Severe Day Time acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140123 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 46122-233_343b4e11-b073-4529-aee5-55cd9347f50d 46122-233 HUMAN OTC DRUG Good Neighbor Pharmacy Night Time Severe Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SUSPENSION ORAL 20140109 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 46122-234_2177247a-ea3f-41b4-a27b-1557f7c7ea5e 46122-234 HUMAN OTC DRUG Good Neighbor Pharmacy Day Time Severe acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SUSPENSION ORAL 20140109 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 46122-235_d2f65adf-35d1-49c2-8b06-6b03a46a1f16 46122-235 HUMAN OTC DRUG good neighbor pharmacy childrens mucus relief dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20140218 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 46122-241_2e7a424d-6626-4772-bb47-bd5d3dd181b3 46122-241 HUMAN OTC DRUG Good Neighbor Pharmacy Loperamide Hydrochloride Loperamide Hydrochloride SUSPENSION ORAL 20140131 ANDA ANDA091292 Amerisource Bergen LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 46122-243_5d45feb2-6f84-4ee3-a764-2563a340e2e4 46122-243 HUMAN OTC DRUG Good Neighbor Pharmacy Triple Antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20140206 OTC MONOGRAPH FINAL part333B Amerisource Bergen BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 46122-244_3d1694ea-3f3e-45d5-8edf-8b31ac7d3a40 46122-244 HUMAN OTC DRUG Good Neighbor Pharmacy Antibiotic and Pain Relief Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20140211 OTC MONOGRAPH FINAL part333B Amerisource Bergen NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 46122-245_5749ce9d-e182-478f-ab88-b520a35a99a7 46122-245 HUMAN OTC DRUG Good Neighbor Pharmacy Night Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140306 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 46122-248_a6bf5862-20d0-4cb1-b664-b50be553dd6c 46122-248 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140131 OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 46122-254_ab93b675-9e76-49d4-a5f5-152ef443231a 46122-254 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex LOZENGE ORAL 20140814 ANDA ANDA203690 Amerisource Bergen NICOTINE 2 mg/1 46122-255_88b8c5df-a617-48c6-9449-c556ba95ded6 46122-255 HUMAN OTC DRUG good neighbor pharmacy nicotine Nicotine Polacrilex LOZENGE ORAL 20140907 ANDA ANDA203690 Amerisource Bergen NICOTINE 4 mg/1 46122-256_2a4b5cce-a3cd-4e96-be6d-f6ace758bbd9 46122-256 HUMAN OTC DRUG Laxative pills maximum strength Sennosides TABLET ORAL 20140731 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good Neighbor Pharmacy) 46122 SENNOSIDES 25 mg/1 46122-257_07f57d8e-e9dc-4aa7-b7de-65f2b2567f78 46122-257 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20140501 OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN 500 mg/1 46122-259_d62b3451-5494-400e-8bbe-f29f15a99b64 46122-259 HUMAN OTC DRUG good neighbor pharmacy flu and severe cold and cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20140731 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 46122-260_2e77e3f1-cb5a-4df7-96ea-b429b1fe0f8f 46122-260 HUMAN OTC DRUG Stool Softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20140630 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good Neighbor Pharmacy) 46122 DOCUSATE CALCIUM 240 mg/1 46122-262_59ea330a-cf07-4e1f-9a31-0f5f2a9a9cce 46122-262 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20140501 OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ASPIRIN 81 mg/1 46122-263_4da6bbf6-e488-4602-918f-b9c05274e782 46122-263 HUMAN OTC DRUG Stool Softener Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140501 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good Neighbor Pharmacy) 46122 DOCUSATE SODIUM 250 mg/1 46122-265_6a62dee0-4a75-4a78-9e84-ed16bc961cb9 46122-265 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140731 OTC MONOGRAPH NOT FINAL part356 AmerisourceBergen (Good Neighbor Pharmacy) 46122 PHENOL 1.4 g/100mL 46122-266_324cc1d7-e222-4da7-b19d-b103109f0c48 46122-266 HUMAN OTC DRUG Good Neighbor Pharmacy Allergy Relief Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20140815 ANDA ANDA076447 Amerisource Bergen FEXOFENADINE HYDROCHLORIDE 180 mg/1 46122-268_8d7ecd9c-3823-403b-9a2d-050879432663 46122-268 HUMAN OTC DRUG good neighbor pharmacy cold and flu night time Acetaminophen, diphenhydramine HCl, phenylephrine HCl TABLET, FILM COATED ORAL 20141109 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 46122-270_133cf96f-f3ef-488e-baa1-6469e0f1f878 46122-270 HUMAN OTC DRUG good neighbor pharmacy sinus relief Acetaminophen, guaifenesin, phenylephrine HCl CAPSULE, COATED ORAL 20141221 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 46122-271_ca2afef0-20ea-4ded-ae86-e57f895b6baa 46122-271 HUMAN OTC DRUG good neighbor pharmacy sinus relief Acetaminophen, guaifenesin, phenylephrine HCl CAPSULE, COATED ORAL 20141106 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 46122-272_8b9211a6-5e8a-48e9-b3fb-ad69dbc758d6 46122-272 HUMAN OTC DRUG good neighbor pharmacy severe sinus congestion Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20141221 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 46122-274_cd7fa5a8-2384-4c85-ba66-3421c2bc7ee1 46122-274 HUMAN OTC DRUG good neighbor pharmacy first aid bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20140730 OTC MONOGRAPH FINAL part333B Amerisource Bergen BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 46122-277_309e94ba-4cd7-4479-909c-496db70588e4 46122-277 HUMAN OTC DRUG good neighbor pharmacy multi symptom Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20141223 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 46122-278_8ebc0585-4fc5-47ca-8a3a-c2c49d274994 46122-278 HUMAN OTC DRUG Sore Throat Menthol Phenol LIQUID ORAL 20140831 OTC MONOGRAPH NOT FINAL part356 AmerisourceBergen (Good Neighbor Pharmacy) 46122 PHENOL 1.4 g/100mL 46122-279_ae071bf4-0e45-4e2a-8877-8886a7a022c0 46122-279 HUMAN OTC DRUG Good Neighbor Pharmacy Diaper Rash Zinc Oxide CREAM TOPICAL 20140923 OTC MONOGRAPH FINAL part347 Amerisource Bergen ZINC OXIDE 13 mg/g 46122-280_512a1bab-33a0-49a7-9415-ece95efaf508 46122-280 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20140930 OTC MONOGRAPH FINAL part347 AmerisourceBergen (Good Neighbor Pharmacy) 46122 WITCH HAZEL 842 mg/mL 46122-282_f4ba5c44-95d6-43ed-8edf-ed42e3d4d19c 46122-282 HUMAN OTC DRUG Good Neighbor Pharmacy Tussin Guaifenesin SYRUP ORAL 20141022 OTC MONOGRAPH FINAL part341 Amerisource Bergen GUAIFENESIN 200 mg/10mL 46122-283_8d13d8b4-5afe-4d16-b91f-c3e134300a4c 46122-283 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141130 NDA NDA021920 AmerisourceBergen (Good Neighbor Pharmacy) 46122 NAPROXEN SODIUM 220 mg/1 46122-284_1adc4c0a-fc6b-46a4-a461-259169776368 46122-284 HUMAN OTC DRUG good neighbor pharmacy nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20141202 ANDA ANDA076777 Amerisource Bergen NICOTINE 2 mg/1 46122-286_6f1682d3-cc1f-42cb-b1e3-12235cb6614f 46122-286 HUMAN OTC DRUG good neighbor pharmacy nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20141022 ANDA ANDA076779 Amerisource Bergen NICOTINE 4 mg/1 46122-287_cbdf3a82-aec5-4890-bd45-16b37c98c20e 46122-287 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20141127 ANDA ANDA076789 Amerisource Bergen NICOTINE 4 mg/1 46122-288_620599b4-b17c-47bb-97cc-07c7a8567731 46122-288 HUMAN OTC DRUG good neighbor pharmacy cleartime Acetaminophen, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20141029 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 46122-408_86601f32-9597-4e8a-95a1-4e7d174cfd82 46122-408 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY CLEANSING PADS WITCH HAZEL SOLUTION RECTAL; TOPICAL 20110601 OTC MONOGRAPH FINAL part346 AMERISOURCE BERGEN WITCH HAZEL .5 mL/mL 46122-500_bec4d347-c500-421f-97d5-1d648125ec4f 46122-500 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 Amerisource Bergen SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 46122-600_9788c057-665e-4352-b03a-022259e5ae76 46122-600 HUMAN OTC DRUG Good Neighbor Mineral Oil Laxative mineral oil ENEMA RECTAL 20120716 OTC MONOGRAPH NOT FINAL part334 Amerisource Bergen MINERAL OIL 118 mL/118mL 46123-001_88e3d3a7-fce9-413f-8ef5-b7f2fa33fdb9 46123-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19670101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 990 mL/L 46123-002_a0351346-e8e1-4a3b-9cfe-df4d9c824d8f 46123-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19670101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 990 mL/L 46123-003_25a4da2a-0ecf-48f7-a6d1-0c88b6d243c4 46123-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19670101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc NITROGEN 990 mL/L 46123-004_44085554-678b-4e6d-bf4a-86b750c2a88d 46123-004 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19670101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc NITROGEN 990 mL/L 46123-005_aa6c9e0e-bb81-4aff-8a3f-cc760a12abb9 46123-005 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 19670101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE 990 g/kg Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-006_85b7d7e3-4fab-428b-ab01-779105a87796 46123-006 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19670101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. NITROUS OXIDE 990 mL/L 46123-007_1891c238-3d97-4417-a3e4-574b0c95e436 46123-007 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19670101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. NITROUS OXIDE 990 mL/L 46123-008_9684c28e-6652-4150-a08c-326349c21a13 46123-008 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19670101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. HELIUM 990 mL/L 46123-009_8b4765ea-a56d-40ac-9ae8-0a2909299a30 46123-009 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19670101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 210 mL/L 46123-010_9676e970-b414-46bd-af91-0b021853a771 46123-010 HUMAN PRESCRIPTION DRUG Oxygen-Helium Mixture Oxygen-Helium Mixture GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 210 mL/L 46123-011_74631d92-a377-49fd-a0cd-382766d9f8ca 46123-011 HUMAN PRESCRIPTION DRUG Oxygen-Helium Mixture Oxygen-Helium Mixture GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 250 mL/L 46123-012_37922097-76ea-44a1-a294-39d3b6aadfe2 46123-012 HUMAN PRESCRIPTION DRUG Oxygen-Helium Mixture Oxygen-Helium Mixture GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 300 mL/L 46123-013_a90ba065-69eb-46e8-abf4-e3d7c6094f89 46123-013 HUMAN PRESCRIPTION DRUG Oxygen-Helium Mixture Oxygen-Helium Mixture GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 330 mL/L 46123-014_6b455fd7-0da6-483c-8c2c-7c83523d183d 46123-014 HUMAN PRESCRIPTION DRUG Oxygen-Helium Mixture Oxygen-Helium Mixture GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 400 mL/L 46123-015_186a27a9-10c2-4110-82da-119625781a96 46123-015 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Air Mixture Carbon Dioxide-Air Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 50; 210 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-016_41c94166-a86f-478c-b649-0cb41e06aafa 46123-016 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Air Mixture Carbon Dioxide-Air Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 70; 210 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-017_91381ef5-247e-4c2d-a6cc-aea0c44e9684 46123-017 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Air Mixture Carbon Dioxide-Air Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 80; 210 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-018_80a0a565-c3fa-46fd-a151-b2f9d8221552 46123-018 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Air Mixture Carbon Dioxide-Air Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 100; 210 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-019_5677d368-b5cf-4719-8049-307e9028afb9 46123-019 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen Mixture Carbon Dioxide-Oxygen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 50; 950 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-020_15eab8aa-dcd4-4cfe-bb05-c22c3527d07d 46123-020 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen Mixture Carbon Dioxide-Oxygen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 70; 930 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-021_85dd8279-28bf-417a-8991-3c4cd42d15ad 46123-021 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen Mixture Carbon Dioxide-Oxygen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 100; 900 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-022_4b848444-a38d-4473-9ddf-d806bd33fc76 46123-022 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen Mixture Carbon Dioxide-Oxygen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 120; 880 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-023_5071b279-e676-465f-b056-ce58c24c6d08 46123-023 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen Mixture Carbon Dioxide-Oxygen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 150; 850 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-024_38ec80f6-e02d-436b-98c1-af4fa3b00566 46123-024 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen Mixture Carbon Dioxide-Oxygen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 200; 800 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-025_327faa0b-d6b5-4a20-9236-10035aa0c706 46123-025 HUMAN PRESCRIPTION DRUG Oxygen-Carbon Dioxide Mixture Oxygen-Carbon Dioxide Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 700; 300 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-026_12b10ea5-21b9-4ebe-951b-acdf89293c9c 46123-026 HUMAN PRESCRIPTION DRUG Oxygen-Carbon Dioxide Mixture Oxygen-Carbon Dioxide Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 800; 200 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-027_3bb49e70-8ca7-4b82-b698-d3a5b97f2779 46123-027 HUMAN PRESCRIPTION DRUG Helium-Oxygen-Nitrogen Mixture Helium-Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. HELIUM; OXYGEN 90; 350 mL/L; mL/L 46123-028_25abe805-bd0f-487a-999c-b41e71633e2d 46123-028 HUMAN PRESCRIPTION DRUG Oxygen-Nitrogen Mixture Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 250 mL/L 46123-029_5549b904-3696-4093-9bc8-5cb68c588317 46123-029 HUMAN PRESCRIPTION DRUG Oxygen-Nitrogen Mixture Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 300 mL/L 46123-030_97173fb0-a700-417c-911a-c0ef21b2bcd1 46123-030 HUMAN PRESCRIPTION DRUG Oxygen-Nitrogen Mixture Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 400 mL/L 46123-031_222145d9-2195-4c79-a29f-a44b6cf37020 46123-031 HUMAN PRESCRIPTION DRUG Oxygen-Nitrogen Mixture Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 500 mL/L 46123-032_9672fed4-8dd8-4870-87a8-32a273b629b4 46123-032 HUMAN PRESCRIPTION DRUG Oxygen-Nitrogen Mixture Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 600 mL/L 46123-033_d891c784-444a-4baf-94aa-1e913510f078 46123-033 HUMAN PRESCRIPTION DRUG Oxygen-Nitrogen Mixture Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 800 mL/L 46123-034_2844e976-7d26-4d11-a00d-7ed5c30f4b4a 46123-034 HUMAN PRESCRIPTION DRUG Oxygen-Nitrogen Mixture Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 900 mL/L 46123-035_7cef2421-ea9f-408a-981b-e66e9512982a 46123-035 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen-Nitrogen Mixture Carbon Dioxide-Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 50; 200 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-036_4d78cfb3-7c2f-46c4-91da-b4a44408de73 46123-036 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen-Nitrogen Mixture Carbon Dioxide-Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 70; 210 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-037_4d57ec5c-da8d-4243-b9c3-3780bd7b51c9 46123-037 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen-Nitrogen Mixture Carbon Dioxide-Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 50; 350 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-038_50ee5865-71fb-4227-88ab-d672c636716c 46123-038 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen-Nitrogen Mixture Carbon Dioxide-Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 50; 400 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-039_319f3662-b0be-4d72-9be2-79632fd756f5 46123-039 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen-Nitrogen Mixture Carbon Dioxide-Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 50; 450 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-040_8fffe9ba-0191-47f1-9d54-8ea03ad26f70 46123-040 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen-Nitrogen Mixture Carbon Dioxide-Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 70; 330 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-041_733efd73-385c-47c4-a395-4727ef9574cb 46123-041 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen-Nitrogen Mixture Carbon Dioxide-Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 100; 250 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46123-042_63e300f8-cae6-40f9-9c16-5f6520aa3915 46123-042 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20111101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46129-200_c045b5a8-b220-4f0a-a831-155b29c19454 46129-200 HUMAN PRESCRIPTION DRUG Antizol fomepizole INJECTION INTRAVENOUS 20090731 NDA NDA020696 PALADIN LABORATORIES (USA) INC FOMEPIZOLE 1 g/mL Antidote [EPC] 46144-146_070bca34-4dea-46dc-816c-32edd1ace0ac 46144-146 HUMAN PRESCRIPTION DRUG SOLAICE MENTHOL,CAPSAICIN PATCH TOPICAL 20141101 UNAPPROVED DRUG OTHER API Solutions, Inc. CAPSAICIN; MENTHOL .05; 5 g/100g; g/100g 46144-941_393aedea-b560-4824-8403-287db1793096 46144-941 HUMAN OTC DRUG FESI MENTHOL, CAPSAICIN PATCH TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part348 API SOLUTIONS INC. CAPSAICIN; MENTHOL .05; 5 g/100g; g/100g 46163-300_239d5e8b-2115-47f4-a850-6c2c65aad62a 46163-300 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAVENOUS 20070412 ANDA ANDA078177 Fresenius Medical Care North America SODIUM CHLORIDE 900 mg/100mL 46287-003_474c65dc-c35c-4c1d-95ca-63eeea8a219c 46287-003 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19850730 ANDA ANDA088138 Carolina Medical Products Company HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 46287-006_4d00d666-5e21-42bf-a367-0d37530f2b54 46287-006 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate sodium polystyrene sulfonate SUSPENSION ORAL; RECTAL 19830101 ANDA ANDA087859 Carolina Medical Products Company SODIUM POLYSTYRENE SULFONATE 15 g/60mL 46287-009_ab959da6-9778-47a8-a08b-7f816ba84694 46287-009 HUMAN PRESCRIPTION DRUG Isoniazid isoniazid SOLUTION ORAL 19831111 ANDA ANDA088235 Carolina Medical Products Company ISONIAZID 50 mg/5mL Antimycobacterial [EPC] 46287-010_b629aa5b-c0fc-4ae7-a2d3-bb1bec07a20e 46287-010 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 19950323 ANDA ANDA089595 Carolina Medical Products Company TRIAMCINOLONE ACETONIDE .5 mg/g 46287-012_eecef28a-f3a4-4344-8e6a-f5df86b6b7a9 46287-012 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate Sodium Polystyrene Sulfonate POWDER, FOR SUSPENSION ORAL; RECTAL 19890119 ANDA ANDA089910 Carolina Medical Products Company SODIUM POLYSTYRENE SULFONATE 1 g/g 46287-014_bc26abed-8e6e-475d-8ab3-abf7d0377003 46287-014 HUMAN PRESCRIPTION DRUG Oracit Citric Acid and Sodium Citrate SOLUTION ORAL 19840515 UNAPPROVED DRUG OTHER Carolina Medical Products Company CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 640; 490 mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 46287-015_86497154-5f50-4ef7-bcf7-d945aa6cca55 46287-015 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride amantadine hydrochloride SOLUTION ORAL 20020911 ANDA ANDA075819 Carolina Medical Products Company AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 46324-2421_5a481188-ea06-4598-9ad5-baa75de49c46 46324-2421 HUMAN OTC DRUG Control Anti-Dandrudff PYRITHIONE ZINC SHAMPOO TOPICAL 20111028 OTC MONOGRAPH FINAL part358H AG Professional Hair Care Products, Ltd PYRITHIONE ZINC 2 mL/100mL 46362-001_b5b3ee82-31cf-4f4c-99e3-26f546128b3e 46362-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19860101 UNAPPROVED MEDICAL GAS Red Ball Oxygen Co., Inc. OXYGEN 992 mL/L 46362-002_cf4f16ad-f340-4110-a613-880c82113d45 46362-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19860101 UNAPPROVED MEDICAL GAS Red Ball Oxygen Co., Inc. NITROGEN 992 mL/L 46362-003_325add96-c4f1-44ef-9adc-74858696e50f 46362-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19860101 UNAPPROVED MEDICAL GAS Red Ball Oxygen Co., Inc. NITROUS OXIDE 992 mL/L 46362-004_54e7ae69-69ab-478d-8b0f-a453a0fee2cd 46362-004 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20110401 UNAPPROVED MEDICAL GAS Red Ball Oxygen Co., Inc. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 46414-2040_b58fff5a-a82f-4467-b6b9-5eeadd5423b5 46414-2040 HUMAN OTC DRUG Medicaine Sting and Bite Benzocaine SWAB TOPICAL 19861115 UNAPPROVED DRUG OTHER James Alexander Corporation BENZOCAINE; MENTHOL .12; .006 g/.6mL; g/.6mL 46414-2222_ae50aae0-d07f-4096-b009-bf424a00f0b5 46414-2222 HUMAN PRESCRIPTION DRUG Amyl Nitrite Amyl Nitrite INHALANT RESPIRATORY (INHALATION) 19790207 UNAPPROVED DRUG OTHER James Alexander Corporation AMYL NITRITE .3 g/.3mL 46414-3333_e1c555ea-fbe6-4860-b9d9-52c9ff836317 46414-3333 HUMAN OTC DRUG Ammonia Inhalants Ammonia Inhalants INHALANT RESPIRATORY (INHALATION) 19760214 UNAPPROVED DRUG OTHER James Alexander Corporation AMMONIA .045 g/.3mL 46414-7777_de5b90e0-9d57-4584-af07-13f0f4260be2 46414-7777 HUMAN OTC DRUG POVIDONE-IODINE POVIDONE-IODINE SOLUTION TOPICAL 19760214 UNAPPROVED DRUG OTHER James Alexander Corporation POVIDONE-IODINE 10 mg/mL 46414-8888_d52699c7-b6cc-424e-8766-017fc4837dee 46414-8888 HUMAN OTC DRUG Benzoin Benzoin SWAB TOPICAL 19761025 UNAPPROVED DRUG OTHER James Alexander Corporation ALOE; BENZOIN; LIQUIDAMBAR STYRACIFLUA RESIN; TOLU BALSAM .12; .6; .48; .24 g/.12mL; g/.6mL; g/.48mL; g/.24mL 46437-001_f6b9f960-4f72-4b38-92d1-0b5b67add8a2 46437-001 HUMAN OTC DRUG Tanda pearl professional whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120803 OTC MONOGRAPH FINAL part355 Syneron Beauty Inc. SODIUM FLUORIDE .33 g/133g 46581-100_60f770a3-1efd-4e24-986f-a9523c55c10d 46581-100 HUMAN OTC DRUG SALONPAS PAIN RELIEVING Camphor, Menthol, Methyl salicylate PATCH PERCUTANEOUS; TOPICAL; TRANSDERMAL 19950301 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 7.1; 33; 36 mg/1; mg/1; mg/1 46581-202_2f833551-1e9d-45b8-a0fc-b20cbbb95c0e 46581-202 HUMAN OTC DRUG SALONPAS PAIN RELIEVING Camphor, Menthol, Methyl salicylate PATCH PERCUTANEOUS; TOPICAL; TRANSDERMAL 19980522 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 28.4; 131; 144 mg/1; mg/1; mg/1 46581-440_04e62a08-d8fd-4bd9-9d48-6b046e5ef6bd 46581-440 HUMAN OTC DRUG Salonpas pain relieving JET Menthol, Methyl salicylate AEROSOL, SPRAY PERCUTANEOUS; TOPICAL; TRANSDERMAL 20110501 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. MENTHOL; METHYL SALICYLATE 3; 10 g/100g; g/100g 46581-480_568c0feb-113c-4968-b000-38a75bc07c07 46581-480 HUMAN OTC DRUG Salonpas pain relieving MASSAGE Menthol, Methyl salicylate AEROSOL, FOAM PERCUTANEOUS; TOPICAL; TRANSDERMAL 20110501 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. MENTHOL; METHYL SALICYLATE 3; 10 g/100g; g/100g 46581-670_1eefe60f-13d6-4df5-8ba6-62b28b3a5194 46581-670 HUMAN OTC DRUG Salonpas Pain Relief Menthol, Methyl Salicylate PATCH PERCUTANEOUS; TOPICAL; TRANSDERMAL 20080425 NDA NDA022029 Hisamitsu Pharmaceutical Co., Inc. MENTHOL; METHYL SALICYLATE 31.5; 105 mg/1; mg/1 46581-680_7402c10e-f276-4383-bba8-d32ad381b1ed 46581-680 HUMAN OTC DRUG Salonpas Arthritis Pain Menthol, Methyl Salicylate PATCH PERCUTANEOUS; TOPICAL; TRANSDERMAL 20080425 NDA NDA022029 Hisamitsu Pharmaceutical Co., Inc. MENTHOL; METHYL SALICYLATE 31.5; 105 mg/1; mg/1 46581-700_93e8582f-66d6-4138-8d32-ea3a282ec106 46581-700 HUMAN OTC DRUG SALONPAS-HOT CAPSICUM Capsaicin PATCH PERCUTANEOUS; TOPICAL; TRANSDERMAL 19981126 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAPSICUM 249 mg/1 46581-730_87f1bc2b-1729-4328-b311-6762c4ff8edf 46581-730 HUMAN OTC DRUG Salonpas pain relieving PATCH HOT Capsaicin OINTMENT PERCUTANEOUS; TOPICAL; TRANSDERMAL 20120101 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAPSICUM OLEORESIN 26.25 mg/1 46581-750_3afe306c-daf8-4735-9b34-fb825de06f46 46581-750 HUMAN OTC DRUG Salonpas pain relieving PATCH HOT LARGE Capsaicin OINTMENT PERCUTANEOUS; TOPICAL; TRANSDERMAL 20120101 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAPSICUM 131.25 mg/1 46581-870_2ce483c2-78dc-40d2-8e89-0a57f4e4e1af 46581-870 HUMAN OTC DRUG Salonpas pain relieving GEL-PATCH HOT Capsaicin, Menthol OINTMENT PERCUTANEOUS; TOPICAL; TRANSDERMAL 20110501 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAPSICUM; MENTHOL 875; 175 mg/1; mg/1 46581-890_cbad04ee-bd6d-4738-afbe-3b6710af5695 46581-890 HUMAN OTC DRUG Salonpas pain relieving GEL-PATCH HOT -L Capsaicin, Menthol OINTMENT PERCUTANEOUS; TOPICAL; TRANSDERMAL 20110501 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAPSICUM; MENTHOL 1250; 250 mg/1; mg/1 46672-036_e561f38f-a5b2-4f62-97f9-0ebe2e34d5d2 46672-036 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20060119 ANDA ANDA040658 Mikart, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 46672-053_5caee91f-cf1c-41e9-ade5-5b7d65e46f41 46672-053 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine TABLET ORAL 19870121 ANDA ANDA089175 Mikart, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 46672-092_69191196-a828-4fb8-a577-511ad0bec0b9 46672-092 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20100609 ANDA ANDA040846 Mikart, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 46672-099_5a0d008b-754a-4e15-bd2f-779ac1f275e8 46672-099 HUMAN PRESCRIPTION DRUG Butapap butalbital and acetaminophen TABLET ORAL 19921026 ANDA ANDA089987 Mikart, Inc. ACETAMINOPHEN; BUTALBITAL 325; 50 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] 46672-138_b72f962a-379d-419b-9b07-5e1e00893cc9 46672-138 HUMAN PRESCRIPTION DRUG phendimetrazine tartrate phendimetrazine tartrate TABLET ORAL 20000705 ANDA ANDA089452 Mikart, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 46672-166_e561f38f-a5b2-4f62-97f9-0ebe2e34d5d2 46672-166 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20060324 ANDA ANDA040556 Mikart, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CV 46672-174_a3becb48-a057-4d3f-b50f-bae21c9a1af2 46672-174 HUMAN PRESCRIPTION DRUG phendimetrazine tartrate phendimetrazine tartrate TABLET ORAL 20000627 ANDA ANDA089452 Mikart, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 46672-192_e561f38f-a5b2-4f62-97f9-0ebe2e34d5d2 46672-192 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20040623 ANDA ANDA040556 Mikart, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 46672-228_46dd17ce-40ca-4a96-bde7-d078e7adc490 46672-228 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine CAPSULE ORAL 19860317 ANDA ANDA089007 Mikart, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 46672-561_39955fe7-caa9-46b2-aabd-dc7818b243dc 46672-561 HUMAN PRESCRIPTION DRUG acetaminophen and codeine phosphate acetaminophen and codeine phosphate LIQUID ORAL 19921027 ANDA ANDA089450 Mikart, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 46672-606_999d4eb9-57ec-48b9-8d8b-0d5f842f05bc 46672-606 HUMAN PRESCRIPTION DRUG amantadine hydrochloride amantadine hydrochloride SYRUP ORAL 19930628 ANDA ANDA074028 Mikart, Inc. AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 46672-633_9d1d4604-7969-4383-98b5-13807acdccac 46672-633 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine SYRUP ORAL 20030131 ANDA ANDA040387 Mikart, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/15mL; mg/15mL; mg/15mL Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 46672-641_ff69c8c2-1490-45b4-a0b8-21a84fb66326 46672-641 HUMAN PRESCRIPTION DRUG ethosuximide ethosuximide SOLUTION ORAL 20031222 ANDA ANDA040506 Mikart, Inc. ETHOSUXIMIDE 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 46672-642_41bea822-9428-4695-aea8-841309fda61c 46672-642 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen SYRUP ORAL 20030925 ANDA ANDA040482 Mikart, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 46672-645_7da90197-5801-4855-956e-a9373b3dec8c 46672-645 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen SYRUP ORAL 20100225 ANDA ANDA040881 Mikart, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 10 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 46672-844_76c76f8e-d8e8-429a-ba67-c270e5ac6c83 46672-844 HUMAN PRESCRIPTION DRUG benzphetamine hydrochloride benzphetamine hydrochloride TABLET ORAL 20111101 ANDA ANDA090473 Mikart, Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 46708-019_a0891a32-105b-48bc-a246-5e179d2e7fa1 46708-019 HUMAN PRESCRIPTION DRUG MEPROBAMATE MEPROBAMATE TABLET ORAL 20130723 ANDA ANDA090122 Alembic Pharmaceuticals Limited MEPROBAMATE 200 mg/1 CIV 46708-020_a0891a32-105b-48bc-a246-5e179d2e7fa1 46708-020 HUMAN PRESCRIPTION DRUG MEPROBAMATE MEPROBAMATE TABLET ORAL 20130723 ANDA ANDA090122 Alembic Pharmaceuticals Limited MEPROBAMATE 400 mg/1 CIV 46708-025_31f3c720-1597-4d43-9296-33017b90b15f 46708-025 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20101101 ANDA ANDA090430 Alembic Pharmaceuticals Limited THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 46708-026_31f3c720-1597-4d43-9296-33017b90b15f 46708-026 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20101101 ANDA ANDA090430 Alembic Pharmaceuticals Limited THEOPHYLLINE ANHYDROUS 450 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 46708-030_9a25f575-09ab-4d32-b73e-5426f08c00c4 46708-030 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130912 ANDA ANDA090429 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 46708-031_9a25f575-09ab-4d32-b73e-5426f08c00c4 46708-031 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130912 ANDA ANDA090429 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 46708-032_9a25f575-09ab-4d32-b73e-5426f08c00c4 46708-032 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130912 ANDA ANDA090429 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 46708-033_9a25f575-09ab-4d32-b73e-5426f08c00c4 46708-033 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130912 ANDA ANDA090429 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 46708-034_9a25f575-09ab-4d32-b73e-5426f08c00c4 46708-034 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130912 ANDA ANDA090429 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 46708-035_9a25f575-09ab-4d32-b73e-5426f08c00c4 46708-035 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130912 ANDA ANDA090429 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 46708-036_9a25f575-09ab-4d32-b73e-5426f08c00c4 46708-036 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130912 ANDA ANDA090429 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 46708-087_bbf22268-86af-41ca-b665-b9b185b57611 46708-087 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20130306 ANDA ANDA202130 Alembic Pharmaceuticals Limited TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 46708-088_bbf22268-86af-41ca-b665-b9b185b57611 46708-088 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20130306 ANDA ANDA202130 Alembic Pharmaceuticals Limited TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 46708-089_bbf22268-86af-41ca-b665-b9b185b57611 46708-089 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20130306 ANDA ANDA202130 Alembic Pharmaceuticals Limited TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 46708-092_6ca3acff-fe7c-483a-a728-39e06c279dbb 46708-092 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride 5 mg Donepezil Hydrochloride TABLET, FILM COATED ORAL 20130304 ANDA ANDA201724 Alembic Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 46708-093_6ca3acff-fe7c-483a-a728-39e06c279dbb 46708-093 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride 5 mg Donepezil Hydrochloride TABLET, FILM COATED ORAL 20130219 ANDA ANDA201724 Alembic Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 46708-112_8c853cd1-de72-4897-ba6d-692bb096eb34 46708-112 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20130425 ANDA ANDA202871 Alembic Pharmaceuticals Limited METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 46708-113_8c853cd1-de72-4897-ba6d-692bb096eb34 46708-113 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20130425 ANDA ANDA202871 Alembic Pharmaceuticals Limited METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 46708-114_8c853cd1-de72-4897-ba6d-692bb096eb34 46708-114 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20130425 ANDA ANDA202871 Alembic Pharmaceuticals Limited METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 46708-128_53df64fc-7fec-4c14-8fe3-c6a128be814a 46708-128 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride 20 mg Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140609 ANDA ANDA202949 Alembic Pharmaceuticals Limited DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 46708-129_53df64fc-7fec-4c14-8fe3-c6a128be814a 46708-129 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride 30 mg Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140609 ANDA ANDA202949 Alembic Pharmaceuticals Limited DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 46708-130_53df64fc-7fec-4c14-8fe3-c6a128be814a 46708-130 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride 60 mg Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140609 ANDA ANDA202949 Alembic Pharmaceuticals Limited DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 46708-134_93ab6237-321e-4a2c-b0ca-3fc9acb31f9a 46708-134 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA203390 Alembic Pharmaceuticals Limited QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 46708-135_93ab6237-321e-4a2c-b0ca-3fc9acb31f9a 46708-135 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA203390 Alembic Pharmaceuticals Limited QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 46708-136_93ab6237-321e-4a2c-b0ca-3fc9acb31f9a 46708-136 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA203390 Alembic Pharmaceuticals Limited QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 46708-137_93ab6237-321e-4a2c-b0ca-3fc9acb31f9a 46708-137 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA203390 Alembic Pharmaceuticals Limited QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 46708-138_93ab6237-321e-4a2c-b0ca-3fc9acb31f9a 46708-138 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA203390 Alembic Pharmaceuticals Limited QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 46708-139_93ab6237-321e-4a2c-b0ca-3fc9acb31f9a 46708-139 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA203390 Alembic Pharmaceuticals Limited QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 46708-209_5b476740-e3f0-4f68-b07c-cd9eb2fa27ca 46708-209 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide 40 mg/12.5 mg Telmisartan and Hydrochlorothiazide TABLET ORAL 20140314 ANDA ANDA203010 Alembic Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 46708-210_5b476740-e3f0-4f68-b07c-cd9eb2fa27ca 46708-210 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg Telmisartan and Hydrochlorothiazide TABLET ORAL 20140314 ANDA ANDA203010 Alembic Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 46708-211_5b476740-e3f0-4f68-b07c-cd9eb2fa27ca 46708-211 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide 80 mg/25 mg Telmisartan and Hydrochlorothiazide TABLET ORAL 20140314 ANDA ANDA203010 Alembic Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; TELMISARTAN 25; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 46783-121_5713eeed-db88-4e10-8ef1-baca3ca8c8ed 46783-121 HUMAN PRESCRIPTION DRUG Asclera POLIDOCANOL INJECTION, SOLUTION INTRAVENOUS 20100601 NDA NDA021201 Merz North America, Inc POLIDOCANOL .005 g/mL Sclerosing Agent [EPC],Sclerosing Activity [MoA],Vascular Sclerosing Activity [PE] 46783-160_475936d3-cdd8-4e57-9e94-7497eb2656e8 46783-160 HUMAN PRESCRIPTION DRUG Xeomin incobotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20110801 BLA BLA125360 Merz Aesthetics. Inc BOTULINUM TOXIN TYPE A 100 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] 46783-161_475936d3-cdd8-4e57-9e94-7497eb2656e8 46783-161 HUMAN PRESCRIPTION DRUG Xeomin incobotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20110801 BLA BLA125360 Merz Aesthetics. Inc BOTULINUM TOXIN TYPE A 50 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] 46783-221_5713eeed-db88-4e10-8ef1-baca3ca8c8ed 46783-221 HUMAN PRESCRIPTION DRUG Asclera POLIDOCANOL INJECTION, SOLUTION INTRAVENOUS 20100601 NDA NDA021201 Merz North America, Inc POLIDOCANOL .01 g/mL Sclerosing Agent [EPC],Sclerosing Activity [MoA],Vascular Sclerosing Activity [PE] 46911-001_4abb85a2-6520-41f1-b55b-96da09225a5b 46911-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS H & C Oxygen, Inc. OXYGEN 99 L/100L 46987-322_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-322 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 46987-323_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-323 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 46987-324_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-324 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 46987-325_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-325 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 46987-326_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-326 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 46987-327_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-327 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120507 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 46987-328_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-328 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120507 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 70 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 46987-329_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-329 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120507 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 130 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 46987-330_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-330 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120507 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 46987-377_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-377 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 46987-410_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-410 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 46987-412_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-412 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 46994-047_7c7a12f2-95c2-4ce5-bab7-005e487bbfa3 46994-047 HUMAN OTC DRUG being well heartburn relief acid reducer Ranitidine TABLET ORAL 20100323 ANDA ANDA078653 Save-A-Lot Food Stores Ltd RANITIDINE HYDROCHLORIDE 150 mg/1 46994-157_1ce6ecea-6702-481d-8ac7-aef5021065f8 46994-157 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20060210 OTC MONOGRAPH FINAL part343 SAVE-A-LOT FOOD STORES, LTD. ASPIRIN 325 mg/1 46994-175_ce465989-7d4e-481e-b4b0-ce2d76e41f9d 46994-175 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 SAVE-A-LOT FOOD STORES, LTD. ACETAMINOPHEN 500 mg/1 46994-235_7bfd7728-c01b-4662-9484-ca3de04232e3 46994-235 HUMAN OTC DRUG Extra Strength Non-Aspirin PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 SAVE-A-LOT FOOD STORES, LTD. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 46994-291_0a4a21e4-9797-4d9b-8e1d-3eb83a956b3f 46994-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 OTC MONOGRAPH NOT FINAL part343 SAVE-A-LOT FOOD STORES, LTD. IBUPROFEN 200 mg/1 46994-302_043feb35-3195-419d-8ee8-ffd8f183bbd6 46994-302 HUMAN OTC DRUG Being Well stomach relief original strength Bismuth subsalicylate SUSPENSION ORAL 20060225 OTC MONOGRAPH FINAL part335 Save-A-Lot Food Stores Ltd BISMUTH SUBSALICYLATE 525 mg/30mL 46994-304_4e665b95-75f8-4f7c-b551-429ca7032de4 46994-304 HUMAN OTC DRUG being well nasal 12 hour oxymetazoline hydrochloride SPRAY NASAL 20060225 OTC MONOGRAPH FINAL part341 Save-A-Lot Food Stores Ltd OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 46994-327_90e2a9c9-0680-4cdb-9ce5-45b91e145662 46994-327 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 SAVE-A-LOT FOOD STORES, LTD. BISACODYL 5 mg/1 46994-329_b50009fb-4faa-4152-8109-8ed30e6934bc 46994-329 HUMAN OTC DRUG Complete Allergy Medicine Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 SAVE-A-LOT FOOD STORES, LTD. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 46994-335_d510ec50-1d43-4a46-8b0c-a4894e3e84bf 46994-335 HUMAN OTC DRUG being well cold and flu relief pm Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20111012 OTC MONOGRAPH FINAL part341 Save-A-Lot Food Stores Ltd ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 46994-359_9c64a345-9f37-40d9-801f-91cc81f2b152 46994-359 HUMAN OTC DRUG Being Well Adult Cough Relief DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20060225 OTC MONOGRAPH FINAL part341 Save-A-Lot Food Stores Ltd DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 46994-368_45a7e1f2-5211-4000-82ef-9d76c6432871 46994-368 HUMAN OTC DRUG Being Well all day pain relief Naproxen Sodium TABLET, FILM COATED ORAL 20060225 ANDA ANDA074661 Save-A-Lot Food Stores Ltd NAPROXEN SODIUM 220 mg/1 46994-453_7509fb30-41c7-427e-9115-36432eeff334 46994-453 HUMAN OTC DRUG Nasal Decongestant Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 SAVE-A-LOT FOOD STORES, LTD. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 46994-458_aeb34d07-2764-4ba3-9a52-503bb7f0d972 46994-458 HUMAN OTC DRUG being well allergy Cetirizine Hydrochloride TABLET ORAL 20080519 ANDA ANDA078336 Save-A-Lot Food Stores Ltd CETIRIZINE HYDROCHLORIDE 10 mg/1 46994-489_ec32f4d4-4ee6-4a7e-bd79-b4ad65c7c570 46994-489 HUMAN OTC DRUG being well antacid Calcium carbonate TABLET, CHEWABLE ORAL 20100901 OTC MONOGRAPH FINAL part331 Save-A-Lot Food Stores Ltd CALCIUM CARBONATE 750 mg/1 46994-500_6566ae73-8322-4254-85cb-a1bcdf46dbab 46994-500 HUMAN OTC DRUG Being Well Body Daily Moisturizing dimethicone LOTION TOPICAL 20130301 OTC MONOGRAPH FINAL part347 Save-A-Lot Food Stores Ltd DIMETHICONE 1.25 g/100mL 46994-503_aafd36f5-d305-457d-b377-378b7600f1e2 46994-503 HUMAN OTC DRUG Hand Sanitizer with Moisturizers and Vitamin E Alcohol GEL TOPICAL 20131125 OTC MONOGRAPH NOT FINAL part333A Save-A-Lot Food Stores Ltd ALCOHOL 70 g/100mL 46994-505_bcc9bb94-2a8a-4309-8caf-7e9dd1cff1ae 46994-505 HUMAN OTC DRUG Being Well Body White Petrolatum OINTMENT TOPICAL 20130301 OTC MONOGRAPH FINAL part347 Save-A-Lot Food Stores Ltd PETROLATUM 1 g/g 46994-510_5ac4701d-89dd-4bc8-85a8-66d66ed8b146 46994-510 HUMAN OTC DRUG BEING WELL BODY 2in1 Dandruff and Conditioner pyrithione zinc SHAMPOO TOPICAL 20130325 OTC MONOGRAPH FINAL part358H Save-A-Lot Food Stores Ltd PYRITHIONE ZINC 1 g/100mL 46994-511_7e2ed247-5bec-4fce-9464-2926aaad6f81 46994-511 HUMAN OTC DRUG BEING WELL BODY Dry Scalp Care pyrithione zinc SHAMPOO TOPICAL 20130325 OTC MONOGRAPH FINAL part358H Save-A-Lot Food Stores Ltd PYRITHIONE ZINC 1 g/100mL 46994-600_9986b033-3c8c-42e7-9276-aee41a0fe506 46994-600 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 SAVE-A-LOT FOOD STORES, LTD. ASPIRIN 81 mg/1 46994-612_624e51b0-fced-4690-aeaa-ff456e884a79 46994-612 HUMAN OTC DRUG Being Well Allergy Relief Loratadine TABLET ORAL 20060225 ANDA ANDA076301 Save-A-Lot Food Stores Ltd LORATADINE 10 mg/1 46994-851_6888c636-4dc7-4236-8dcf-f00e680fc735 46994-851 HUMAN OTC DRUG Being Well Extra Strength Menthol Heat Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 SAVE-A-LOT FOOD STORES, LTD. MENTHOL 750 mg/1 46994-852_3605581d-c4c6-483e-9fed-a23310e8f5af 46994-852 HUMAN OTC DRUG Being Well Heartburn Relief Ranitidine TABLET, FILM COATED ORAL 20130909 ANDA ANDA091429 Save-A-Lot Food Stores Ltd RANITIDINE HYDROCHLORIDE 150 mg/1 46994-897_c60da003-60e5-4620-bd5e-a963d7862c37 46994-897 HUMAN OTC DRUG being well ibuprofen Ibuprofen SUSPENSION ORAL 20060225 ANDA ANDA074937 Save-A-Lot Food Stores Ltd IBUPROFEN 100 mg/5mL 46994-908_e9bc87f8-de71-49fa-b42a-dd6e04a19fcb 46994-908 HUMAN OTC DRUG being well cold flu relief pm multi symptom acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20061115 OTC MONOGRAPH FINAL part341 Save-A-Lot Food Stores Ltd ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 46994-915_85808fa3-694a-4de6-9c61-bb9d0bca2e9d 46994-915 HUMAN OTC DRUG being well omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080320 NDA NDA022032 Save-A-Lot Food Stores Ltd OMEPRAZOLE 20 mg/1 47047-2444_d79cd1d4-f388-4cf2-aa72-18355289ab8a 47047-2444 HUMAN OTC DRUG Chigarid CAMPHOR (SYNTHETIC), PHENOL, MENTHOL SOLUTION TOPICAL 20110707 OTC MONOGRAPH NOT FINAL part348 Colgin Inc CAMPHOR (SYNTHETIC); MENTHOL; PHENOL 28; 1; 15 mg/100mL; mg/100mL; mg/100mL 47066-402_37d4cc31-7bb1-4d5c-b8b1-832d1a569d2f 47066-402 HUMAN OTC DRUG Foam Safe Povidone Iodine LIQUID TOPICAL 20120401 OTC MONOGRAPH FINAL part333C Gremed Manufacturing LLC POVIDONE-IODINE 7.5 mg/100mL 47066-403_25f5037c-0bab-4f9e-aabd-1d4f51559d6c 47066-403 HUMAN OTC DRUG Foam Safe Chlorhexidine Gluconate 4% Solution Antiseptic LIQUID TOPICAL 20130101 NDA NDA019127 Germed Manufacturing LLC CHLORHEXIDINE GLUCONATE 4 g/100mL 47124-055_3f2356fa-1bad-4f1d-9b90-c4c605d20648 47124-055 HUMAN OTC DRUG Wegmans Aloe and Vitamin E Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Wegmans Food Markets Inc. BENZALKONIUM CHLORIDE .115 g/1 47124-177_995617c9-bd5c-45dd-ba16-5c89da6f9261 47124-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC TRICLOSAN .46 mL/100mL 47124-221_abe318f4-bfd3-4a5c-8766-b775af713351 47124-221 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC TRICLOSAN .15 mL/100mL 47124-232_f0b858f5-66f0-4e7b-8dde-f01c96c5e4d9 47124-232 HUMAN OTC DRUG Wegmans Antibacterial Cucumber Melon TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Wegman Food Markets Inc TRICLOSAN .115 mL/100mL 47124-294_d28f4581-7a35-453a-910c-1f74b4bb778d 47124-294 HUMAN OTC DRUG WEGMANS ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120413 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC. TRICLOSAN .15 mL/100mL 47124-295_db69b3b2-1538-4fd9-8885-68c200f48455 47124-295 HUMAN OTC DRUG ANTIBACTERIAL CUCUMBER MELON TRICLOSAN LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC TRICLOSAN .115 mL/100mL 47124-295_fd2883b4-ffe7-41d8-9c33-7b8bc1ce4ebd 47124-295 HUMAN OTC DRUG ANTIBACTERIAL CUCUMBER MELON TRICLOSAN LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC TRICLOSAN .115 mL/100mL 47124-299_b7ee97b6-07b2-4753-91c7-971b9417c640 47124-299 HUMAN OTC DRUG WEGMANS TRICLOSAN LIQUID TOPICAL 20130328 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC. TRICLOSAN 1.5 mg/mL 47124-326_b7778217-4e61-4a05-a4d9-e8be19c48a28 47124-326 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20140203 OTC MONOGRAPH NOT FINAL part356 Wegmans Food Markets EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 47124-406_5c5de2a4-aa7e-4cdd-b180-dcfc35268f11 47124-406 HUMAN OTC DRUG WEGMANS HAND SANITIZER THAI BAMBOO ETHYL ALCOHOL LIQUID TOPICAL 20141123 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC ALCOHOL 650 mg/mL 47124-406_da114cbc-3a64-4a47-80e7-f07f7765f558 47124-406 HUMAN OTC DRUG WEGMANS HAND SANITIZER THAI BAMBOO ETHYL ALCOHOL LIQUID TOPICAL 20141123 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC ALCOHOL 650 mg/mL 47124-407_9e7985a1-8468-4613-8286-8c37e954b48d 47124-407 HUMAN OTC DRUG WEGMANS HAND SANITIZER LYCHEE BERRY ETHYL ALCOHOL LIQUID TOPICAL 20141123 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC ALCOHOL 650 mg/mL 47124-407_fe65bf77-7b42-4a5f-8101-a8509bf3703b 47124-407 HUMAN OTC DRUG WEGMANS HAND SANITIZER LYCHEE BERRY ETHYL ALCOHOL LIQUID TOPICAL 20141116 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC ALCOHOL 650 mg/mL 47124-434_7c9c19d8-3e5f-40b9-9bbc-ed364fa1d1e2 47124-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20131122 OTC MONOGRAPH NOT FINAL part356 Wegmans Food Markets, inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 47124-720_02b942cf-698e-4199-9529-27cd1292c6fe 47124-720 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC TRICLOSAN .115 mL/100mL 47124-720_1fa5a00a-38a4-4ba9-8caf-364bb0afba80 47124-720 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC TRICLOSAN .115 mL/100mL 47124-720_cda6d730-3dea-4651-be6f-928445afa574 47124-720 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC TRICLOSAN .115 mL/100mL 47124-721_46388d66-3209-4651-ae23-161cd2a0a8bd 47124-721 HUMAN OTC DRUG WEGMANS ANTIBACTERIAL WITH MOISTURIZERS TRICLOSAN LIQUID TOPICAL 20130328 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC. TRICLOSAN 1.15 mg/mL 47202-1141_1c8a6538-a816-4bba-94a0-0760c10052cb 47202-1141 HUMAN OTC DRUG Moisturizing Hand Sanitizer Ethyl Alcohol LOTION TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Susanne Lang Fragrance Inc. ALCOHOL .62 mL/mL 47202-1142_1c8a6538-a816-4bba-94a0-0760c10052cb 47202-1142 HUMAN OTC DRUG Moisturizing Hand Sanitizer Ethyl Alcohol LOTION TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Susanne Lang Fragrance Inc. ALCOHOL .62 mL/mL 47202-1143_1c8a6538-a816-4bba-94a0-0760c10052cb 47202-1143 HUMAN OTC DRUG Moisturizing Hand Sanitizer Ethyl Alcohol LOTION TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Susanne Lang Fragrance Inc. ALCOHOL .62 mL/mL 47202-1401_a29a0e6b-f9fd-48e3-8e33-7ead0133d5a4 47202-1401 HUMAN OTC DRUG Bite Beauty SPF 15 Sheer Balm Octinoxate Oxybenzone OINTMENT TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 47202-1402_a29a0e6b-f9fd-48e3-8e33-7ead0133d5a4 47202-1402 HUMAN OTC DRUG Bite Beauty SPF 15 Sheer Balm Octinoxate Oxybenzone OINTMENT TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 47202-1403_a29a0e6b-f9fd-48e3-8e33-7ead0133d5a4 47202-1403 HUMAN OTC DRUG Bite Beauty SPF 15 Sheer Balm Octinoxate Oxybenzone OINTMENT TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 47202-1404_a29a0e6b-f9fd-48e3-8e33-7ead0133d5a4 47202-1404 HUMAN OTC DRUG Bite Beauty SPF 15 Sheer Balm Octinoxate Oxybenzone OINTMENT TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 47202-1405_a29a0e6b-f9fd-48e3-8e33-7ead0133d5a4 47202-1405 HUMAN OTC DRUG Bite Beauty SPF 15 Sheer Balm Octinoxate Oxybenzone OINTMENT TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 47202-1406_a29a0e6b-f9fd-48e3-8e33-7ead0133d5a4 47202-1406 HUMAN OTC DRUG Bite Beauty SPF 15 Sheer Balm Octinoxate Oxybenzone OINTMENT TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 47202-1407_a29a0e6b-f9fd-48e3-8e33-7ead0133d5a4 47202-1407 HUMAN OTC DRUG Bite Beauty SPF 15 Sheer Balm Octinoxate Oxybenzone OINTMENT TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 47202-1408_a29a0e6b-f9fd-48e3-8e33-7ead0133d5a4 47202-1408 HUMAN OTC DRUG Bite Beauty SPF 15 Sheer Balm Octinoxate Oxybenzone OINTMENT TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 47202-1501_944f5b9a-0b8c-4ebc-9efa-e02932647995 47202-1501 HUMAN OTC DRUG Bite Beauty Octinoxate, Oxybenzone OINTMENT TOPICAL 20140313 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 47202-1502_944f5b9a-0b8c-4ebc-9efa-e02932647995 47202-1502 HUMAN OTC DRUG Bite Beauty Octinoxate, Oxybenzone OINTMENT TOPICAL 20140313 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 47202-1503_944f5b9a-0b8c-4ebc-9efa-e02932647995 47202-1503 HUMAN OTC DRUG Bite Beauty Octinoxate, Oxybenzone OINTMENT TOPICAL 20140313 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 47202-1504_944f5b9a-0b8c-4ebc-9efa-e02932647995 47202-1504 HUMAN OTC DRUG Bite Beauty Octinoxate, Oxybenzone OINTMENT TOPICAL 20140313 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 47202-1505_944f5b9a-0b8c-4ebc-9efa-e02932647995 47202-1505 HUMAN OTC DRUG Bite Beauty Octinoxate, Oxybenzone OINTMENT TOPICAL 20140313 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 47202-1506_041c1f97-d20d-4bb8-be66-5c2fefe8a720 47202-1506 HUMAN OTC DRUG Lip Love Ultimate Lip Rescue Octinoxate, Oxybenzone KIT 20141003 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. 47219-102_4f7c4940-c4ba-11de-b031-0002a5d5c51b 47219-102 HUMAN OTC DRUG COBROXIN FOR CHRONIC PAIN NAJA NAJA VENOM SPRAY, METERED ORAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM .043 mg/mL 47219-104_2b33a420-c87f-11de-ab47-0002a5d5c51b 47219-104 HUMAN OTC DRUG COBROXIN FOR CHRONIC PAIN NAJA NAJA VENOM GEL TOPICAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM .02 mg/mL 47219-200_62c5a261-fb94-429c-8dcd-912818bd7a88 47219-200 HUMAN OTC DRUG Nyloxin NAJA NAJA VENOM SPRAY, METERED ORAL 20100823 UNAPPROVED HOMEOPATHIC Receptopharm Inc. NAJA NAJA VENOM 4 [hp_X]/mL 47219-201_9287af80-d915-11de-893d-0002a5d5c51b 47219-201 HUMAN OTC DRUG NYLOXIN Stage 2 Pain Relief NAJA NAJA VENOM SPRAY, METERED ORAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM .07 mg/mL 47219-202_bb43c7e0-d9d0-11de-b59b-0002a5d5c51b 47219-202 HUMAN OTC DRUG NYLOXIN Stage 2 Pain Relief NAJA NAJA VENOM SPRAY, METERED ORAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM .1 mg/mL 47219-203_4817aae0-ddc5-11de-a5b9-0002a5d5c51b 47219-203 HUMAN OTC DRUG NYLOXIN Stage 2 Pain Relief NAJA NAJA VENOM SPRAY, METERED ORAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM .035 mg/mL 47219-204_bd776560-d9ff-11de-8d68-0002a5d5c51b 47219-204 HUMAN OTC DRUG NYLOXIN Stage 2 Pain Relief NAJA NAJA VENOM GEL TOPICAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM .02 mg/mL 47219-210_d662abef-a1af-49e2-ba95-4ed6b294ca20 47219-210 HUMAN OTC DRUG Nyloxin NAJA NAJA VENOM SPRAY, METERED ORAL 20100823 UNAPPROVED HOMEOPATHIC Receptopharm Inc. NAJA NAJA VENOM 3 [hp_X]/mL 47219-250_2ce90140-d912-11de-b0c5-0002a5d5c51b 47219-250 HUMAN OTC DRUG NYLOXIN Stage 3 Pain Relief NAJA NAJA VENOM SPRAY, METERED ORAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM 140 ug/mL 47219-251_7256a740-d931-11de-ae13-0002a5d5c51b 47219-251 HUMAN OTC DRUG NYLOXIN Stage 3 Pain Relief NAJA NAJA VENOM SPRAY, METERED ORAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM 280 ug/mL 47219-252_0fbb0300-d932-11de-8d29-0002a5d5c51b 47219-252 HUMAN OTC DRUG NYLOXIN Stage 3 Pain Relief NAJA NAJA VENOM SPRAY, METERED ORAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM 350 ug/mL 47219-253_8d5c7de0-ddbd-11de-9b36-0002a5d5c51b 47219-253 HUMAN OTC DRUG NYLOXIN Stage 3 Pain Relief NAJA NAJA VENOM GEL TOPICAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM 60 ug/mL 47219-300_e9854727-aa35-4f2b-9174-47faf8bb85cc 47219-300 HUMAN OTC DRUG Nyloxin NAJA NAJA VENOM GEL TOPICAL 20100823 UNAPPROVED HOMEOPATHIC Receptopharm Inc. NAJA NAJA VENOM 4 [hp_X]/mL 47219-300_f281ef65-9576-4006-b79e-fb4963e96c1e 47219-300 HUMAN OTC DRUG Nyloxin NAJA NAJA VENOM GEL TOPICAL 20100823 UNAPPROVED HOMEOPATHIC Receptopharm Inc. NAJA NAJA VENOM 4 [hp_X]/mL 47219-301_7f5ca81b-075b-46b8-bc3d-d61aacfa3e5d 47219-301 HUMAN OTC DRUG Nyloxin NAJA NAJA VENOM GEL TOPICAL 20100823 UNAPPROVED HOMEOPATHIC Receptopharm Inc. NAJA NAJA VENOM 4 [hp_X]/mL 47219-310_ed694f5d-a8f0-4219-99fb-cb9abcc272b7 47219-310 HUMAN OTC DRUG Nyloxin NAJA NAJA VENOM GEL TOPICAL 20100823 UNAPPROVED HOMEOPATHIC Receptopharm Inc. NAJA NAJA VENOM 4 [hp_X]/mL 47219-311_ef6ac736-4094-4c95-9106-9760d9dfadc3 47219-311 HUMAN OTC DRUG Nyloxin NAJA NAJA VENOM GEL TOPICAL 20100823 UNAPPROVED HOMEOPATHIC Receptopharm Inc. NAJA NAJA VENOM 4 [hp_X]/mL 47242-0001_1d1e7751-5353-4d54-b15a-508e764ef95d 47242-0001 HUMAN OTC DRUG Allergy RELIEF ONION - CAUSTICUM - EUPHRASIA STRICTA - SODIUM CHLORIDE - WYETHIA HELENIOIDES ROOT - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. CAUSTICUM; EUPHRASIA STRICTA; ONION; SODIUM CHLORIDE; WYETHIA HELENIOIDES ROOT 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 47242-0011_ccc4521a-325d-4fb9-a1b3-db9695280d90 47242-0011 HUMAN OTC DRUG Cough and Cold RELIEF ONION - ARSENIC TRIOXIDE - FERROSOFERRIC PHOSPHATE - CANIS LUPUS FAMILIARIS MILK - SODIUM CHLORIDE - STRYCHNOS NUX-VOMICA SEED - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ARSENIC TRIOXIDE; CANIS LUPUS FAMILIARIS MILK; FERROSOFERRIC PHOSPHATE; ONION; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 47242-0021_8e3c50ef-5f9e-4c43-bb05-b9531bbd96c8 47242-0021 HUMAN OTC DRUG Flu RELIEF ACONITUM NAPELLUS - CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE - ARSENIC TRIOXIDE - BRYONIA ALBA ROOT - GELSEMIUM SEMPERVIRENS ROOT - STRYCHNOS NUX-VOMICA SEED - PULSATILLA VULGARIS - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 47242-0031_4765bf8e-9bc8-464f-b330-8bc2947ea93c 47242-0031 HUMAN OTC DRUG Hang Over RELIEF ARSENIC TRIOXIDE - IPECAC - STRYCHNOS NUX-VOMICA SEED - VERATRUM ALBUM ROOT - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ARSENIC TRIOXIDE; IPECAC; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 47242-0041_8ad67f0e-55d6-46ad-892a-5a0ea55a6a57 47242-0041 HUMAN OTC DRUG Jet Lag RELIEF ACONITUM NAPELLUS - SILVER NITRATE - ARNICA MONTANA - ARSENIC TRIOXIDE - ARABICA COFFEE BEAN - GELSEMIUM SEMPERVIRENS ROOT - STRYCHNOS NUX-VOMICA SEED - TOBACCO LEAF - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ACONITUM NAPELLUS; ARABICA COFFEE BEAN; ARNICA MONTANA; ARSENIC TRIOXIDE; GELSEMIUM SEMPERVIRENS ROOT; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 47242-0051_d8e5810e-7619-4e3c-826c-37012cf8ad3a 47242-0051 HUMAN OTC DRUG PMS RELIEF OYSTER SHELL CALCIUM CARBONATE, CRUDE - POTASSIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - SEPIA OFFICINALIS JUICE - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 47242-0061_afb3dc8b-79f8-4c9c-ad64-077171f1b5f1 47242-0061 HUMAN OTC DRUG Sleep RELIEF ARSENIC TRIOXIDE - ARABICA COFFEE BEAN - NITRIC ACID - TOXICODENDRON PUBESCENS LEAF - SELENIUM - ZINC - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; NITRIC ACID; SELENIUM; TOXICODENDRON PUBESCENS LEAF; ZINC 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 47242-0071_d2222074-b9f3-40ad-88f0-d6977891b074 47242-0071 HUMAN OTC DRUG Stress RELIEF MATRICARIA RECUTITA - ARABICA COFFEE BEAN - PHYSOSTIGMA VENENOSUM SEED - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ARABICA COFFEE BEAN; MATRICARIA RECUTITA; PHYSOSTIGMA VENENOSUM SEED 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 47242-0081_0eb6cade-4779-4005-9955-345fc79f9b1c 47242-0081 HUMAN OTC DRUG Headache RELIEF BRYONIA ALBA ROOT - GELSEMIUM SEMPERVIRENS ROOT - SANGUINARIA CANADENSIS ROOT - SPIGELIA ANTHELMIA - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 47242-0091_e08b6d67-9c24-4eef-93ec-e345e09038ea 47242-0091 HUMAN OTC DRUG Weight Loss RELIEF OYSTER SHELL CALCIUM CARBONATE, CRUDE - IRON - GRAPHITE - POTASSIUM CARBONATE - SODIUM CHLORIDE - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. GRAPHITE; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; SODIUM CHLORIDE 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 47242-0201_42aa8809-b9c8-4690-848b-d9c09a75987f 47242-0201 HUMAN OTC DRUG Childrens Colic RELIEF ANTIMONY TRISULFIDE - MATRICARIA RECUTITA - STRYCHNOS NUX-VOMICA SEED - LYCOPODIUM CLAVATUM SPORE - PULSATILLA VULGARIS - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ANTIMONY TRISULFIDE; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 47242-0211_540c397b-a7a0-4337-baf1-79bb2bfd9ed5 47242-0211 HUMAN OTC DRUG Childrens Cough and Cold RELIEF ARSENIC TRIOXIDE - FERROSOFERRIC PHOSPHATE - PULSATILLA VULGARIS - SILICON DIOXIDE - DROSERA ROTUNDIFOLIA - SPONGIA OFFICINALIS SKELETON, ROASTED - SAMBUCUS NIGRA FLOWERING TOP - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ARSENIC TRIOXIDE; DROSERA ROTUNDIFOLIA; FERROSOFERRIC PHOSPHATE; PULSATILLA VULGARIS; SAMBUCUS NIGRA FLOWERING TOP; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 6; 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 47242-0221_6f1ad4d3-83b8-4e30-90a5-b6390bc8ac9d 47242-0221 HUMAN OTC DRUG Childrens Earache RELIEF ARSENIC TRIOXIDE - MATRICARIA RECUTITA - ACONITUM NAPELLUS - PULSATILLA VULGARIS - MERCURIUS SOLUBILIS - SILICON DIOXIDE - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SILICON DIOXIDE 6; 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 47242-0231_00aca081-db2e-4c65-8a54-2c20b8ddfbd3 47242-0231 HUMAN OTC DRUG Childrens Teething RELIEF TRIBASIC CALCIUM PHOSPHATE - MATRICARIA RECUTITA - ARABICA COFFEE BEAN - RHEUM OFFICINALE ROOT - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ARABICA COFFEE BEAN; MATRICARIA RECUTITA; RHEUM OFFICINALE ROOT; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 47285-291_90f66c4a-89a0-4f84-9ae4-6e3f3613f7c6 47285-291 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19410101 UNAPPROVED MEDICAL GAS James C. Dawes Company, Inc OXYGEN 99 L/100L 47335-001_3fa84022-dddc-4cb8-b91d-1a1a6ae83efa 47335-001 HUMAN PRESCRIPTION DRUG Carbidopa, levodopa and entacapone Carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20121002 NDA AUTHORIZED GENERIC NDA021485 Sun Pharma Global FZE CARBIDOPA; ENTACAPONE; LEVODOPA 12.5; 200; 50 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 47335-002_3fa84022-dddc-4cb8-b91d-1a1a6ae83efa 47335-002 HUMAN PRESCRIPTION DRUG Carbidopa, levodopa and entacapone Carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20121002 NDA AUTHORIZED GENERIC NDA021485 Sun Pharma Global FZE CARBIDOPA; ENTACAPONE; LEVODOPA 18.75; 200; 75 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 47335-003_3fa84022-dddc-4cb8-b91d-1a1a6ae83efa 47335-003 HUMAN PRESCRIPTION DRUG Carbidopa, levodopa and entacapone Carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120401 NDA AUTHORIZED GENERIC NDA021485 Sun Pharma Global FZE CARBIDOPA; ENTACAPONE; LEVODOPA 25; 200; 100 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 47335-004_3fa84022-dddc-4cb8-b91d-1a1a6ae83efa 47335-004 HUMAN PRESCRIPTION DRUG Carbidopa, levodopa and entacapone Carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20121002 NDA AUTHORIZED GENERIC NDA021485 Sun Pharma Global FZE CARBIDOPA; ENTACAPONE; LEVODOPA 31.25; 200; 125 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 47335-005_3fa84022-dddc-4cb8-b91d-1a1a6ae83efa 47335-005 HUMAN PRESCRIPTION DRUG Carbidopa, levodopa and entacapone Carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120401 NDA AUTHORIZED GENERIC NDA021485 Sun Pharma Global FZE CARBIDOPA; ENTACAPONE; LEVODOPA 37.5; 200; 150 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 47335-006_3fa84022-dddc-4cb8-b91d-1a1a6ae83efa 47335-006 HUMAN PRESCRIPTION DRUG Carbidopa, levodopa and entacapone Carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20121002 NDA AUTHORIZED GENERIC NDA021485 Sun Pharma Global FZE CARBIDOPA; ENTACAPONE; LEVODOPA 50; 200; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 47335-007_fa022925-2f70-466a-a539-a0a51e71bef8 47335-007 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20130401 NDA AUTHORIZED GENERIC NDA020796 Sun Pharma Global FZE ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 47335-035_8a1dd187-0df0-46df-9636-e1cfb08678cf 47335-035 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130304 ANDA ANDA202746 Sun Pharma Global FZE ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 47335-046_fe056042-fdd4-48f8-91df-e9652bd02801 47335-046 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140409 ANDA ANDA202922 Sun Pharma Global FZE OXALIPLATIN 50 mg/10mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 47335-047_fe056042-fdd4-48f8-91df-e9652bd02801 47335-047 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140409 ANDA ANDA202922 Sun Pharma Global FZE OXALIPLATIN 100 mg/20mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 47335-049_181cdddb-ce0d-496f-acc3-7a9d8ca8fe8f 47335-049 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTABLE, LIPOSOMAL INTRAVENOUS 20130205 ANDA ANDA203263 Sun Pharma Global FZE DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 47335-050_181cdddb-ce0d-496f-acc3-7a9d8ca8fe8f 47335-050 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTABLE, LIPOSOMAL INTRAVENOUS 20130205 ANDA ANDA203263 Sun Pharma Global FZE DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 47335-082_52e7503a-14bc-4964-8680-6302c1c70a6b 47335-082 HUMAN PRESCRIPTION DRUG LIPODOX Doxorubicin Hydrochloride INJECTABLE, LIPOSOMAL INTRAVENOUS 20120209 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Sun Pharma Global FZE DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 47335-083_52e7503a-14bc-4964-8680-6302c1c70a6b 47335-083 HUMAN PRESCRIPTION DRUG LIPODOX 50 Doxorubicin Hydrochloride INJECTABLE, LIPOSOMAL INTRAVENOUS 20120209 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Sun Pharma Global FZE DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 47335-144_ccce3205-06b3-494b-9969-b5c2e25b7484 47335-144 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20070910 ANDA ANDA077058 Sun Pharma Global FZE PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 47335-150_2ccca2f5-518d-438c-8e62-5b1bcf2005b7 47335-150 HUMAN PRESCRIPTION DRUG carboplatin carboplatin INJECTION INTRAVENOUS 20080919 ANDA ANDA077926 Sun Pharma Global FZE CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 47335-151_2ccca2f5-518d-438c-8e62-5b1bcf2005b7 47335-151 HUMAN PRESCRIPTION DRUG carboplatin carboplatin INJECTION INTRAVENOUS 20080919 ANDA ANDA077926 Sun Pharma Global FZE CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 47335-153_90b6ff1e-82b8-4af6-bd5e-7959987161cd 47335-153 HUMAN PRESCRIPTION DRUG GEMCITABINE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA078433 Sun Pharma Global FZE GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 47335-154_90b6ff1e-82b8-4af6-bd5e-7959987161cd 47335-154 HUMAN PRESCRIPTION DRUG GEMCITABINE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA078433 Sun Pharma Global FZE GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 47335-175_0cdfe958-0efe-4cf4-9ead-4a2b2dd0d207 47335-175 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET, FILM COATED ORAL 20130205 ANDA ANDA090362 Sun Pharma Global FZE LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 47335-176_bd7c29b3-bcaa-4a1d-830b-fd178c9f5e00 47335-176 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090819 ANDA ANDA078818 Sun Pharma Global FZE OXALIPLATIN 50 mg/10mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 47335-178_bd7c29b3-bcaa-4a1d-830b-fd178c9f5e00 47335-178 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090819 ANDA ANDA078818 Sun Pharma Global FZE OXALIPLATIN 100 mg/20mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 47335-186_48e0f2ec-b217-4c25-a71c-20e173d05edb 47335-186 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING ORAL 20141215 ANDA ANDA078690 Sun Pharma Global FZE CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 47335-187_48e0f2ec-b217-4c25-a71c-20e173d05edb 47335-187 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING ORAL 20141215 ANDA ANDA078690 Sun Pharma Global FZE CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 47335-188_48e0f2ec-b217-4c25-a71c-20e173d05edb 47335-188 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING ORAL 20141215 ANDA ANDA078690 Sun Pharma Global FZE CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 47335-203_45a4aa4d-d68e-4c00-8113-f0238ca48e78 47335-203 HUMAN PRESCRIPTION DRUG ENTACAPONE ENTACAPONE TABLET, FILM COATED ORAL 20120718 ANDA ANDA090690 Sun Pharma Global FZE ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 47335-219_2c76b8f9-5385-4c98-aebb-bdca8613d24b 47335-219 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION/ DROPS OPHTHALMIC 20141215 ANDA ANDA090017 Sun Pharma Global FZE KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 47335-220_2c76b8f9-5385-4c98-aebb-bdca8613d24b 47335-220 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION/ DROPS OPHTHALMIC 20141215 ANDA ANDA090017 Sun Pharma Global FZE KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 47335-221_2c76b8f9-5385-4c98-aebb-bdca8613d24b 47335-221 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION/ DROPS OPHTHALMIC 20141215 ANDA ANDA090017 Sun Pharma Global FZE KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 47335-231_c6f583ee-38ee-41f5-82cb-d3962f63db73 47335-231 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20130112 ANDA ANDA202047 Sun Pharma Global FZE RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 47335-232_c6f583ee-38ee-41f5-82cb-d3962f63db73 47335-232 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20130112 ANDA ANDA202047 Sun Pharma Global FZE RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 47335-276_6ea7fa16-e2fd-4436-adf9-f4cf070dade3 47335-276 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate INJECTION SUBCUTANEOUS 20110622 ANDA ANDA090358 Sun Pharma Global FZE SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 47335-284_2ccca2f5-518d-438c-8e62-5b1bcf2005b7 47335-284 HUMAN PRESCRIPTION DRUG carboplatin carboplatin INJECTION INTRAVENOUS 20140303 ANDA ANDA077926 Sun Pharma Global FZE CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 47335-285_2db029de-56c4-44cf-a2ac-7229515d5214 47335-285 HUMAN PRESCRIPTION DRUG DOCEFREZ docetaxel anhydrous KIT 20110503 NDA NDA022534 Sun Pharma Global FZE 47335-289_72e06321-17c1-433c-be2d-3414e1508997 47335-289 HUMAN PRESCRIPTION DRUG CAFFEINE CITRATE CAFFEINE CITRATE INJECTION INTRAVENOUS 20091001 ANDA ANDA090077 Sun Pharma Global FZE CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 47335-289_d06d3810-9923-4199-be5e-ee5ee086b0a4 47335-289 HUMAN PRESCRIPTION DRUG Caffeine Citrate Caffeine Citrate INJECTION INTRAVENOUS 20140605 ANDA ANDA090077 Sun Pharma Global FZE CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 47335-290_72e06321-17c1-433c-be2d-3414e1508997 47335-290 HUMAN PRESCRIPTION DRUG CAFFEINE CITRATE CAFFEINE CITRATE SOLUTION ORAL 20091001 ANDA ANDA090357 Sun Pharma Global FZE CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 47335-290_d06d3810-9923-4199-be5e-ee5ee086b0a4 47335-290 HUMAN PRESCRIPTION DRUG Caffeine Citrate Caffeine Citrate SOLUTION ORAL 20140602 ANDA ANDA090357 Sun Pharma Global FZE CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 47335-300_2ccca2f5-518d-438c-8e62-5b1bcf2005b7 47335-300 HUMAN PRESCRIPTION DRUG carboplatin carboplatin INJECTION INTRAVENOUS 20080919 ANDA ANDA077926 Sun Pharma Global FZE CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 47335-326_06fba9a4-456f-40ac-92e3-1e8d5a0143d0 47335-326 HUMAN PRESCRIPTION DRUG NALTREXONE HYDROCHLORIDE NALTREXONE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120229 ANDA ANDA090356 Sun Pharma Global FZE NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] 47335-330_0d64737d-e021-417d-8646-47131e074496 47335-330 HUMAN PRESCRIPTION DRUG CHLOROTHIAZIDE SODIUM CHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110805 ANDA ANDA091546 Sun Pharma Global FZE CHLOROTHIAZIDE SODIUM 500 mg/18mL Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 47335-343_54812a5b-ce4a-47ff-a481-0ed36ca17f5d 47335-343 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20110926 ANDA ANDA090142 Sun Pharma Global FZE CETIRIZINE HYDROCHLORIDE 5 mg/1 47335-343_a4e249fd-9e95-4d8b-bd9a-d97cef34fa3c 47335-343 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20110909 ANDA ANDA090142 Sun Pharma Global FZE CETIRIZINE HYDROCHLORIDE 5 mg/1 47335-344_54812a5b-ce4a-47ff-a481-0ed36ca17f5d 47335-344 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20110926 ANDA ANDA090142 Sun Pharma Global FZE CETIRIZINE HYDROCHLORIDE 10 mg/1 47335-344_a4e249fd-9e95-4d8b-bd9a-d97cef34fa3c 47335-344 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20110909 ANDA ANDA090142 Sun Pharma Global FZE CETIRIZINE HYDROCHLORIDE 10 mg/1 47335-361_e0cd96a1-f1e3-4bfc-9475-789036215f6a 47335-361 HUMAN PRESCRIPTION DRUG decitabine decitabine KIT 20140124 NDA NDA205582 Sun Pharma Global FZE 47335-381_fb0d33c1-e1d5-4d92-9ed8-3edf46a20ec7 47335-381 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090745 Sun Pharma Global FZE DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 47335-382_fb0d33c1-e1d5-4d92-9ed8-3edf46a20ec7 47335-382 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090745 Sun Pharma Global FZE DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 47335-383_fb0d33c1-e1d5-4d92-9ed8-3edf46a20ec7 47335-383 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090745 Sun Pharma Global FZE DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 47335-485_8b533fe4-287f-482c-b530-d9a5bf2ce40c 47335-485 HUMAN PRESCRIPTION DRUG bicalutamide bicalutamide TABLET, FILM COATED ORAL 20141215 ANDA ANDA079110 Sun Pharma Global FZE BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 47335-508_a5098626-95a1-4c97-a0f3-f83a22ce9f89 47335-508 HUMAN PRESCRIPTION DRUG Esomeprazole Sodium Esomeprazole Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140103 ANDA ANDA200882 Sun Pharma Global FZE ESOMEPRAZOLE SODIUM 20 mg/5mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 47335-509_a5098626-95a1-4c97-a0f3-f83a22ce9f89 47335-509 HUMAN PRESCRIPTION DRUG Esomeprazole Sodium Esomeprazole Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140103 ANDA ANDA200882 Sun Pharma Global FZE ESOMEPRAZOLE SODIUM 40 mg/5mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 47335-531_b08b6d2e-9512-4076-b95d-44b42e99f7e8 47335-531 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111230 ANDA ANDA091607 Sun Pharma Global FZE TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 47335-533_b08b6d2e-9512-4076-b95d-44b42e99f7e8 47335-533 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111230 ANDA ANDA091607 Sun Pharma Global FZE TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 47335-537_b08b6d2e-9512-4076-b95d-44b42e99f7e8 47335-537 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111230 ANDA ANDA091607 Sun Pharma Global FZE TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 47335-539_73a785cf-3a0e-44cf-8ace-406a878265bf 47335-539 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140627 ANDA ANDA200484 Sun Pharma Global FZE NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 47335-573_e3939379-2a2e-415f-8248-1cc18e2ab572 47335-573 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130909 ANDA ANDA203059 Sun Pharma Global FZE LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 47335-576_e3939379-2a2e-415f-8248-1cc18e2ab572 47335-576 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130909 ANDA ANDA203059 Sun Pharma Global FZE LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 47335-580_ccce3205-06b3-494b-9969-b5c2e25b7484 47335-580 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20070910 ANDA ANDA077058 Sun Pharma Global FZE PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 47335-581_b5eb6d8a-2792-402c-914e-5648b4133885 47335-581 HUMAN PRESCRIPTION DRUG AMIFOSTINE AMIFOSTINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080314 ANDA ANDA077126 Sun Pharma Global FZE AMIFOSTINE 50 mg/mL 47335-586_7706723d-e856-45f5-9452-4a88e628eac8 47335-586 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Sun Pharma Global FZE ESZOPICLONE 1 mg/1 CIV 47335-587_7706723d-e856-45f5-9452-4a88e628eac8 47335-587 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Sun Pharma Global FZE ESZOPICLONE 2 mg/1 CIV 47335-588_7706723d-e856-45f5-9452-4a88e628eac8 47335-588 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Sun Pharma Global FZE ESZOPICLONE 3 mg/1 CIV 47335-603_e28ada86-2079-4e0c-aebc-a867d378ee80 47335-603 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 Sun Pharma Global FZE ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 47335-604_e28ada86-2079-4e0c-aebc-a867d378ee80 47335-604 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 Sun Pharma Global FZE ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 47335-605_e28ada86-2079-4e0c-aebc-a867d378ee80 47335-605 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 Sun Pharma Global FZE ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 47335-606_e28ada86-2079-4e0c-aebc-a867d378ee80 47335-606 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 Sun Pharma Global FZE ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 47335-613_73a785cf-3a0e-44cf-8ace-406a878265bf 47335-613 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140627 ANDA ANDA200484 Sun Pharma Global FZE NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 47335-614_73a785cf-3a0e-44cf-8ace-406a878265bf 47335-614 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140627 ANDA ANDA201273 Sun Pharma Global FZE NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 47335-635_55337fd5-6eda-4b92-9405-a6446ad06a2b 47335-635 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20141215 ANDA ANDA090022 Sun Pharma Global FZE ALENDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 47335-636_55337fd5-6eda-4b92-9405-a6446ad06a2b 47335-636 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20141215 ANDA ANDA090022 Sun Pharma Global FZE ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 47335-637_55337fd5-6eda-4b92-9405-a6446ad06a2b 47335-637 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20141215 ANDA ANDA090022 Sun Pharma Global FZE ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 47335-638_55337fd5-6eda-4b92-9405-a6446ad06a2b 47335-638 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20141215 ANDA ANDA090022 Sun Pharma Global FZE ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 47335-669_ff07142b-7fac-4ac6-826b-0548492726a0 47335-669 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20101115 ANDA ANDA090421 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 47335-670_ff07142b-7fac-4ac6-826b-0548492726a0 47335-670 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20101115 ANDA ANDA090421 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 47335-671_ff07142b-7fac-4ac6-826b-0548492726a0 47335-671 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20101115 ANDA ANDA090421 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 47335-672_ff07142b-7fac-4ac6-826b-0548492726a0 47335-672 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20101115 ANDA ANDA090421 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 47335-673_ff07142b-7fac-4ac6-826b-0548492726a0 47335-673 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20101115 ANDA ANDA090421 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 47335-675_6f71ba5e-7bd6-409a-80c6-2f22d975aefc 47335-675 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 47335-676_6f71ba5e-7bd6-409a-80c6-2f22d975aefc 47335-676 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 47335-677_6f71ba5e-7bd6-409a-80c6-2f22d975aefc 47335-677 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 47335-678_6f71ba5e-7bd6-409a-80c6-2f22d975aefc 47335-678 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 47335-679_6f71ba5e-7bd6-409a-80c6-2f22d975aefc 47335-679 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 47335-707_87f82719-2c7e-4cea-b656-c80b225c9ebf 47335-707 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141215 ANDA ANDA090278 Sun Pharma Global FZE TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 47335-710_87f82719-2c7e-4cea-b656-c80b225c9ebf 47335-710 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141215 ANDA ANDA090278 Sun Pharma Global FZE TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 47335-711_87f82719-2c7e-4cea-b656-c80b225c9ebf 47335-711 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141215 ANDA ANDA090278 Sun Pharma Global FZE TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 47335-712_87f82719-2c7e-4cea-b656-c80b225c9ebf 47335-712 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141215 ANDA ANDA090278 Sun Pharma Global FZE TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 47335-714_8c1a888f-b47d-4218-9a01-7607b1608e0d 47335-714 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20130701 ANDA ANDA090508 Sun Pharma Global FZE FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 47335-715_dbaece37-0d99-4c6b-88c0-3107581d9d49 47335-715 HUMAN PRESCRIPTION DRUG FINASTERIDE FINASTERIDE TABLET, FILM COATED ORAL 20110818 ANDA ANDA090507 Sun Pharma Global FZE FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 47335-727_c71de79e-19b7-4255-8d84-d57d9521e246 47335-727 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20140611 ANDA ANDA090886 Sun Pharma Global FZE RISEDRONATE SODIUM HEMI-PENTAHYDRATE 75 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 47335-736_6385b004-46f2-470d-bba3-3643c9ebbde3 47335-736 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 Sun Pharma Global FZE BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 47335-737_6385b004-46f2-470d-bba3-3643c9ebbde3 47335-737 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 Sun Pharma Global FZE BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 47335-738_6385b004-46f2-470d-bba3-3643c9ebbde3 47335-738 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 Sun Pharma Global FZE BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 47335-747_f1773afa-4756-4493-8775-00617f0183d6 47335-747 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20140130 NDA NDA205583 Sun Pharma Global FZE DESVENLAFAXINE FUMARATE MONOHYDRATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 47335-779_2b3a50cf-757d-423e-ba4a-ce0fb18a6eeb 47335-779 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride Azelastine Hydrochloride SPRAY, METERED NASAL 20120524 ANDA ANDA090423 Sun Pharma Global FZE AZELASTINE HYDROCHLORIDE 137 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 47335-788_b47d691e-28a9-4e10-92b8-310aecc2f953 47335-788 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate SOLUTION NASAL 20131224 ANDA ANDA078271 Sun Pharma Global FZE DESMOPRESSIN ACETATE .1 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 47335-804_f1773afa-4756-4493-8775-00617f0183d6 47335-804 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20140130 NDA NDA205583 Sun Pharma Global FZE DESVENLAFAXINE FUMARATE MONOHYDRATE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 47335-814_76b8f7da-7e69-4953-be59-e38397e0fd36 47335-814 HUMAN PRESCRIPTION DRUG Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE ORAL 20101005 ANDA ANDA079020 Sun Pharma Global FZE ATOMOXETINE HYDROCHLORIDE 10 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 47335-815_76b8f7da-7e69-4953-be59-e38397e0fd36 47335-815 HUMAN PRESCRIPTION DRUG Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE ORAL 20101005 ANDA ANDA079020 Sun Pharma Global FZE ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 47335-816_76b8f7da-7e69-4953-be59-e38397e0fd36 47335-816 HUMAN PRESCRIPTION DRUG Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE ORAL 20101005 ANDA ANDA079020 Sun Pharma Global FZE ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 47335-817_76b8f7da-7e69-4953-be59-e38397e0fd36 47335-817 HUMAN PRESCRIPTION DRUG Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE ORAL 20101005 ANDA ANDA079020 Sun Pharma Global FZE ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 47335-818_76b8f7da-7e69-4953-be59-e38397e0fd36 47335-818 HUMAN PRESCRIPTION DRUG Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE ORAL 20101005 ANDA ANDA079020 Sun Pharma Global FZE ATOMOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 47335-819_76b8f7da-7e69-4953-be59-e38397e0fd36 47335-819 HUMAN PRESCRIPTION DRUG Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE ORAL 20101005 ANDA ANDA079020 Sun Pharma Global FZE ATOMOXETINE HYDROCHLORIDE 80 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 47335-820_76b8f7da-7e69-4953-be59-e38397e0fd36 47335-820 HUMAN PRESCRIPTION DRUG Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE ORAL 20101005 ANDA ANDA079020 Sun Pharma Global FZE ATOMOXETINE HYDROCHLORIDE 100 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 47335-833_416d38ad-e6de-40bc-8f44-c24b6adb74e5 47335-833 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090814 ANDA ANDA078417 Sun Pharma Global FZE FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 47335-834_416d38ad-e6de-40bc-8f44-c24b6adb74e5 47335-834 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090814 ANDA ANDA078417 Sun Pharma Global FZE FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 47335-835_4b42825e-4c47-4581-8f83-50d11cf51c38 47335-835 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide Galantamine Hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20110209 ANDA ANDA090178 Sun Pharma Global FZE GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 47335-836_4b42825e-4c47-4581-8f83-50d11cf51c38 47335-836 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide Galantamine Hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20110209 ANDA ANDA090178 Sun Pharma Global FZE GALANTAMINE HYDROBROMIDE 16 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 47335-837_4b42825e-4c47-4581-8f83-50d11cf51c38 47335-837 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide Galantamine Hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20110209 ANDA ANDA090178 Sun Pharma Global FZE GALANTAMINE HYDROBROMIDE 24 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 47335-859_4db11250-6436-4eee-aa3d-d28cf215c48e 47335-859 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111212 ANDA ANDA201384 Sun Pharma Global FZE TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 47335-860_4db11250-6436-4eee-aa3d-d28cf215c48e 47335-860 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111212 ANDA ANDA201384 Sun Pharma Global FZE TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 47335-861_4db11250-6436-4eee-aa3d-d28cf215c48e 47335-861 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111212 ANDA ANDA201384 Sun Pharma Global FZE TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 47335-890_df982639-6949-45f5-b5cd-41f28b336477 47335-890 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20140213 ANDA ANDA201742 Sun Pharma Global FZE TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 47335-891_df982639-6949-45f5-b5cd-41f28b336477 47335-891 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20140213 ANDA ANDA201742 Sun Pharma Global FZE TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 47335-892_df982639-6949-45f5-b5cd-41f28b336477 47335-892 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20140213 ANDA ANDA201742 Sun Pharma Global FZE TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 47335-893_df982639-6949-45f5-b5cd-41f28b336477 47335-893 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20140213 ANDA ANDA201742 Sun Pharma Global FZE TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 47335-894_429a7086-f41f-416d-993e-45ef9c8a073e 47335-894 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120518 ANDA ANDA090494 Sun Pharma Global FZE CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 47335-902_80eaf200-2326-4308-9b78-e61b39ad9ee6 47335-902 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Sun Pharma Global FZE QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 47335-903_80eaf200-2326-4308-9b78-e61b39ad9ee6 47335-903 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Sun Pharma Global FZE QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 47335-904_80eaf200-2326-4308-9b78-e61b39ad9ee6 47335-904 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Sun Pharma Global FZE QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 47335-905_80eaf200-2326-4308-9b78-e61b39ad9ee6 47335-905 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Sun Pharma Global FZE QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 47335-906_80eaf200-2326-4308-9b78-e61b39ad9ee6 47335-906 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Sun Pharma Global FZE QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 47335-907_80eaf200-2326-4308-9b78-e61b39ad9ee6 47335-907 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Sun Pharma Global FZE QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 47335-909_ba350186-e20d-4611-9c82-db09fb46c275 47335-909 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa and Entacapone Carbidopa, Levodopa and Entacapone TABLET, FILM COATED ORAL 20120522 ANDA ANDA079085 Sun Pharma Global FZE CARBIDOPA; ENTACAPONE; LEVODOPA 25; 200; 100 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 47335-910_ba350186-e20d-4611-9c82-db09fb46c275 47335-910 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa and Entacapone Carbidopa, Levodopa and Entacapone TABLET, FILM COATED ORAL 20120522 ANDA ANDA079085 Sun Pharma Global FZE CARBIDOPA; ENTACAPONE; LEVODOPA 37.5; 200; 150 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 47335-923_9bd78c0b-1bee-44af-a6d8-a742872470b3 47335-923 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130916 ANDA ANDA202637 Sun Pharma Global FZE LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 47335-924_9bd78c0b-1bee-44af-a6d8-a742872470b3 47335-924 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130916 ANDA ANDA091509 Sun Pharma Global FZE LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 47335-928_c71de79e-19b7-4255-8d84-d57d9521e246 47335-928 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20140611 ANDA ANDA090886 Sun Pharma Global FZE RISEDRONATE SODIUM HEMI-PENTAHYDRATE 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 47335-929_df982639-6949-45f5-b5cd-41f28b336477 47335-929 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20140213 ANDA ANDA201742 Sun Pharma Global FZE TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 47335-930_df982639-6949-45f5-b5cd-41f28b336477 47335-930 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20140213 ANDA ANDA201742 Sun Pharma Global FZE TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 47335-931_a14da3ee-a731-4282-be9d-407473517470 47335-931 HUMAN PRESCRIPTION DRUG vecuronium bromide vecuronium bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141215 ANDA ANDA079001 Sun Pharma Global FZE VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 47335-932_a14da3ee-a731-4282-be9d-407473517470 47335-932 HUMAN PRESCRIPTION DRUG vecuronium bromide vecuronium bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141215 ANDA ANDA079001 Sun Pharma Global FZE VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 47335-937_f7eaf630-4d39-4071-ab07-78db51ba78b5 47335-937 HUMAN PRESCRIPTION DRUG IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTION INTRAVENOUS 20080421 ANDA ANDA078805 Sun Pharma Global FZE IRINOTECAN HYDROCHLORIDE 40 mg/2mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 47335-938_04e5eede-17ff-4765-af77-d46c139da703 47335-938 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride Azelastine Hydrochloride SOLUTION/ DROPS INTRAOCULAR 20100531 ANDA ANDA078738 Sun Pharma Global FZE AZELASTINE HYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 47335-953_f7eaf630-4d39-4071-ab07-78db51ba78b5 47335-953 HUMAN PRESCRIPTION DRUG IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTION INTRAVENOUS 20080421 ANDA ANDA078805 Sun Pharma Global FZE IRINOTECAN HYDROCHLORIDE 100 mg/5mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 47335-954_2389c2fd-5217-4b3d-a754-b0a36b3f4736 47335-954 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141225 ANDA ANDA200695 Sun Pharma Global FZE BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 47335-956_4bb73ebf-a032-4954-b063-45bf89df3b12 47335-956 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111122 ANDA ANDA079057 Sun Pharma Global FZE ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 47335-962_1d65711e-82df-4225-8569-1d97a00aa294 47335-962 HUMAN PRESCRIPTION DRUG zoledronic acid zoledronic acid KIT 20130304 ANDA ANDA090018 Sun Pharma Global FZE 47335-978_acc80123-8a62-49e2-a537-13e99238d080 47335-978 HUMAN PRESCRIPTION DRUG ZOLMITRIPTAN ZOLMITRIPTAN TABLET, FILM COATED ORAL 20141124 ANDA ANDA203476 Sun Pharma Global FZE ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 47335-979_acc80123-8a62-49e2-a537-13e99238d080 47335-979 HUMAN PRESCRIPTION DRUG ZOLMITRIPTAN ZOLMITRIPTAN TABLET, FILM COATED ORAL 20141124 ANDA ANDA203476 Sun Pharma Global FZE ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 47341-002_a6b5ed46-bf0e-4e9e-8ced-a6645ee59148 47341-002 HUMAN OTC DRUG Burn-B Gone OTC Burn-B Gone OTC GEL TOPICAL 20100510 OTC MONOGRAPH FINAL part347 Quantum Labs LLC ALLANTOIN .75 g/75g 47469-100_0beaafdd-060b-4d95-a354-5b909ac5a742 47469-100 HUMAN OTC DRUG SUPER PLUS PERFECT BB SPF30 PA PLUS PLUS BRIGHT Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 HANSKIN CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 3.13; .43 g/30mL; g/30mL 47469-110_e2471751-4444-4bab-84a3-a1171fbc8e78 47469-110 HUMAN OTC DRUG SUPER PLUS PERFECT BB SPF30 PA PLUS PLUS NATURAL Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 HANSKIN CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 3.13; .43 g/30mL; g/30mL 47469-120_629f5666-97ff-4ab2-bf4f-d8b6d5a9d35a 47469-120 HUMAN OTC DRUG SUPER LIGHT TOUCH BB SPF30 PA PLUS PLUS Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 HANSKIN CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 3.13; .43 g/30mL; g/30mL 47469-130_ef966266-fbe5-4c83-abfb-fe626c86d83b 47469-130 HUMAN OTC DRUG SUPER LIGHT TOUCH BB PACT SPF30 PA PLUS PLUS Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 HANSKIN CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.57; .22 g/15g; g/15g 47584-001_8c60f6f1-db86-4f23-bdc5-7af36e37bc95 47584-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F18 INJECTION INTRAVENOUS 20111208 ANDA ANDA203665 Cyclotron Partners LP dba Cyclotope FLUDEOXYGLUCOSE F-18 500 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 47584-002_d31845a1-1be5-4da1-a08f-2600eb0a663f 47584-002 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F-18 INJECTION INTRAVENOUS 20111208 ANDA ANDA203544 Houston Cyclotron Partners LP dba Cyclotope SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 47584-003_353bd7ef-caa5-4360-b1ec-2f068c7008fd 47584-003 HUMAN PRESCRIPTION DRUG Ammonia N 13 AMMONIA N-13 INJECTION INTRAVENOUS 20110804 ANDA ANDA203543 Houston Cyclotron Partners LP dba Cyclotope AMMONIA N-13 260 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 47593-114_c81a1310-c212-4e2a-aa58-068d76978e89 47593-114 HUMAN OTC DRUG EpiCare Antimicrobial Lotion Soap Healthcare personnel handwash SOLUTION TOPICAL 20060711 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. CHLOROXYLENOL .6 mL/100mL 47593-130_5cafd8b3-8d4d-4f9c-8042-4e06dbb33a6e 47593-130 HUMAN OTC DRUG Epi Vera E Antimicrobial Lotion Soap Antiseptic handwash SOLUTION TOPICAL 20021230 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. CHLOROXYLENOL .8 mL/100mL 47593-169_cc9486a5-e137-4cff-a621-16435147cc56 47593-169 HUMAN OTC DRUG Bacti-Foam Triclosan SOLUTION TOPICAL 19970711 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL 47593-170_bfc7d2d0-d06b-45ab-a66d-252ae0844cd0 47593-170 HUMAN OTC DRUG Bacti-Stat AE Triclosan SOLUTION TOPICAL 19970714 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3.06 mg/mL 47593-173_446195c2-8710-42f9-b32c-0ca0f1555fd1 47593-173 HUMAN OTC DRUG Alphadine Scrub Foam Antimicrobial Foam Surgical hand scrub, General skin cleanser SOLUTION TOPICAL 20000205 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. IODINE 7.5 mL/100mL 47593-178_5831cd36-c41a-49f8-b593-cb9ce0fe99eb 47593-178 HUMAN OTC DRUG Bacti-Stat triclosan SOLUTION TOPICAL 19970123 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3.06 mg/mL 47593-190_b52fb7af-e83a-42c1-9c32-302a8aff46c9 47593-190 HUMAN OTC DRUG Medi-Scrub Chloroxylenol SOLUTION TOPICAL 19870112 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 6.12 mg/mL 47593-244_57d2e41a-0199-4c05-ae8e-6884e464c396 47593-244 HUMAN OTC DRUG Endure 250 Triclosan SOLUTION TOPICAL 19990608 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 10.3 mg/mL 47593-262_42353f35-1971-458b-8676-f156b6753f8e 47593-262 HUMAN OTC DRUG Endure 100 Triclosan SOLUTION TOPICAL 19981120 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 2.05 mg/mL 47593-263_02f2ad0a-35f3-4829-916f-2773e903a484 47593-263 HUMAN OTC DRUG Endure 200 Triclosan SOLUTION TOPICAL 19981120 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 10.35 mg/mL 47593-264_b072567d-a830-4d94-ab07-28396f42b2a8 47593-264 HUMAN OTC DRUG Endure 300 Cida Rinse Gel Antimicrobial Hand Rinse Antiseptic handwash SOLUTION TOPICAL 19991122 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. ETHANOL 70 mL/100mL 47593-266_bbcda0bb-1e29-4c61-bdee-f0bef163dc9b 47593-266 HUMAN OTC DRUG EpiCare Plus Antimicrobial Skin Cleanser Antiseptic handwash SOLUTION TOPICAL 19990416 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. TRICLOSAN .3 mL/100mL 47593-275_8fa31b4e-afc7-4a65-a20b-16e5c70fe04c 47593-275 HUMAN OTC DRUG EcoCare 360 Benzalkonium SOLUTION TOPICAL 19990223 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE .1 mL/100mL 47593-279_41f63e7b-8fd5-4f6b-97a2-29cd66d74d1c 47593-279 HUMAN OTC DRUG Alphadine Scrub Topical Microbiocidal Skin Cleanser Surgical Hand Scrub/General Skin Cleanser SOLUTION TOPICAL 19970619 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. IODINE 7.5 mL/100mL 47593-280_c9f9dc8f-33ba-45b6-804f-f3ab66990c5e 47593-280 HUMAN OTC DRUG Quik-Care Waterless Antimicrobial Foaming Hand Rub Antiseptic handwash SOLUTION TOPICAL 19990506 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. ETHANOL 54.7 g/100g 47593-284_bb7ed87f-bb79-4d98-b1ad-3fc1b023b11a 47593-284 HUMAN OTC DRUG Clean Force chloroxylenol SOLUTION TOPICAL 19990601 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL .6 mL/100mL 47593-305_d0788e2e-70ad-4f2e-b7a3-d7799a998578 47593-305 HUMAN OTC DRUG DigiClean E Hand Soap Antiseptic handwash SOLUTION TOPICAL 19990526 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. TRICLOSAN .3 mL/100mL 47593-307_d85d7c5a-f82d-45e6-8815-2500172a36bd 47593-307 HUMAN OTC DRUG Ecolab Digiclean Triclosan SOLUTION TOPICAL 19990526 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mL/100mL 47593-308_9aa078d6-2501-4d48-a769-305739336273 47593-308 HUMAN OTC DRUG DigiClean E Foam Hand Soap Antiseptic handwash SOLUTION TOPICAL 19990526 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. CHLOROXYLENOL 1 mL/100mL 47593-311_4152f071-8e61-4d29-89b9-f9e8f15dadf0 47593-311 HUMAN OTC DRUG DigiSan Hand Sanitizer Alcohol SOLUTION TOPICAL 20010110 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 54.7 g/100g 47593-315_a90a7e2d-3986-463b-97d6-955d5b15d4dd 47593-315 HUMAN OTC DRUG Sanigizer Plus Alcohol SOLUTION TOPICAL 19990622 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 534 mg/mL 47593-316_714cef2b-b73c-4bda-8d57-ff6abb78f109 47593-316 HUMAN OTC DRUG Puritan Hand Sanitizer Antiseptic handwash SOLUTION TOPICAL 19990628 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. ETHANOL 60 mL/100mL 47593-336_cf32e7d3-8538-493b-9c45-a2fac8d92d9f 47593-336 HUMAN OTC DRUG EpiSoft Foaming Antibacterial Lotin Soap Antiseptic handwash SOLUTION TOPICAL 20000310 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. TRICLOSAN .3 mL/100mL 47593-341_56c19e80-1dcd-4dc6-bfc1-1e83beb34621 47593-341 HUMAN OTC DRUG Keystone triclosan SOLUTION TOPICAL 20000726 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mL/100mL 47593-342_113254b4-b473-465e-aaf8-fce19342940c 47593-342 HUMAN OTC DRUG EcoCare 275 Chloroxylenol SOLUTION TOPICAL 20000815 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 1 mL/100mL 47593-356_4d8ea810-5194-4909-894e-db7a0742ddaf 47593-356 HUMAN OTC DRUG Renown Antiseptic Hand Cleaner for Gentle Hand Care Antiseptic handwash SOLUTION TOPICAL 20010716 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. CHLOROXYLENOL .8 mL/100mL 47593-359_a7e11ba6-4405-4dd4-b4cf-b75cfaa977a4 47593-359 HUMAN OTC DRUG Keystone Benzalkonium Chloride SOLUTION TOPICAL 20020726 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE .1 mL/100mL 47593-360_d13179a1-7c4e-413b-876f-6b35f1009f41 47593-360 HUMAN OTC DRUG EcoCare 250 Triclosan SOLUTION TOPICAL 20020831 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL 47593-362_74244ec4-157e-420e-bc79-d619cc4f3007 47593-362 HUMAN OTC DRUG EcoCare 270 Antiseptic handwash SOLUTION TOPICAL 20020831 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. CHLOROXYLENOL .9 mL/100mL 47593-363_7563adf0-cf77-4069-a44a-0ad1a9e3716c 47593-363 HUMAN OTC DRUG EcoCare 350 Hand Sanitizer with Skin Conditioner Antiseptic hand wash SOLUTION TOPICAL 20021226 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. ISOPROPYL ALCOHOL 75 mL/100mL 47593-381_e4aa4d25-d5a4-4d8b-b449-f958f34b8896 47593-381 HUMAN OTC DRUG DigiClean Slim-Line Triclosan SOLUTION TOPICAL 20030415 OTC MONOGRAPH FINAL part333E Ecolab Inc. TRICLOSAN .3 mL/100mL 47593-383_79eeebc1-0d8b-4107-8acc-12d90cc5bc25 47593-383 HUMAN OTC DRUG Eco-Clean Elite Triclosan SOLUTION TOPICAL 20040830 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mL/100mL 47593-385_39023364-945a-45ab-a038-e536b9295d09 47593-385 HUMAN OTC DRUG Eco-Clean Elite Foam Hand Sanitizer Antiseptic handwash SOLUTION TOPICAL 20020809 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. BENZALKONIUM CHLORIDE .1 mL/100mL 47593-387_1e1fdc60-3b46-41f2-af17-a8323d5524a8 47593-387 HUMAN OTC DRUG DigiClean Slim-Line Hand Sanitizer Benzalkonim chloride SOLUTION TOPICAL 20020726 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE .1 mL/100mL 47593-388_b2559151-5be4-4005-8c5f-9a0c865244cf 47593-388 HUMAN OTC DRUG DIGISAN Healthcare Hand Sanitizer Antiseptic handwash SOLUTION TOPICAL 20040317 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. ETHANOL 70 mL/100mL 47593-390_cfe22132-d11d-4c82-9a94-78f2e0833fd8 47593-390 HUMAN OTC DRUG Digiclean Triclosan SOLUTION TOPICAL 20031027 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mL/100mL 47593-391_45d47846-b5f0-440f-8401-001dd2f52812 47593-391 HUMAN OTC DRUG Clean Force Triclosan SOLUTION TOPICAL 20040729 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mL/100mL 47593-392_5cacdeda-119c-4f09-bdca-982673ecb9c0 47593-392 HUMAN OTC DRUG Puritan Triclosan SOLUTION TOPICAL 20040729 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mL/100mL 47593-404_a2dc9616-da91-45ea-bf7c-855fa71443c3 47593-404 HUMAN OTC DRUG DigiSan E Foam Hand Sanitizer Antiseptic handwash SOLUTION TOPICAL 20031104 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. BENZALKONIUM CHLORIDE .1 mL/100mL 47593-406_5b618eb0-dbab-4fa2-97c0-2b863611570c 47593-406 HUMAN OTC DRUG Clean Force Hand Sanitizer Antiseptic handwash SOLUTION TOPICAL 20031027 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. ETHANOL 60 mL/100mL 47593-408_f18a21c8-a592-4214-af70-d8def8e80043 47593-408 HUMAN OTC DRUG Endure 320 Advanced Care Waterless Antimicrobial Hand Rinse with Moisturizers Anitspetic handwash SOLUTION TOPICAL 20031027 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. ETHANOL 62 mL/100mL 47593-409_887e7900-eb81-417e-aebe-bed45393aa42 47593-409 HUMAN OTC DRUG DigiSan Alcohol AEROSOL, FOAM TOPICAL 20031031 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 62.5 g/100g 47593-410_6fd20f30-d049-49a5-bf00-e8fc3b52864d 47593-410 HUMAN OTC DRUG Clean Force Foam Hand Sanitizer Antiseptic handwash SOLUTION TOPICAL 20031027 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. BENZALKONIUM CHLORIDE .1 mL/100mL 47593-413_ba01b446-79d4-42ae-82a4-1994fa54b477 47593-413 HUMAN OTC DRUG Endure 300 Hand Sanitizer Antiseptic handwash SOLUTION TOPICAL 20050531 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. ETHANOL 70 mL/100mL 47593-416_c1c2f7c4-9f03-4c53-a46c-7072cb52edbf 47593-416 HUMAN OTC DRUG Keystone Classic Foam Hand Sanitizer Antiseptic handwash SOLUTION TOPICAL 20040317 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. BENZALKONIUM CHLORIDE .1 mL/100mL 47593-428_31388222-7a5b-4599-a6b9-cbdd55bcf876 47593-428 HUMAN OTC DRUG DigiKlenz Antibacterial Hand Soap Antiseptic handwash SOLUTION TOPICAL 20051007 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. TRICLOSAN .3 mL/100mL 47593-431_bac2ba50-fcf4-473d-8f0a-d061a6f953ca 47593-431 HUMAN OTC DRUG Endure 450 Surgical and Healthcare Personnel Hand Antiseptic with Moisturizers Alcohol hand sanitizer SOLUTION TOPICAL 20051128 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. ETHANOL 62 mL/100mL 47593-438_0acab3e9-27da-477f-bbd0-98b5147aaf40 47593-438 HUMAN OTC DRUG Proforce Commercial Products triclosan SOLUTION TOPICAL 20080310 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mL/100mL 47593-443_2874976b-9356-4997-91a8-06af1d90f52a 47593-443 HUMAN OTC DRUG Antibacterial Clean and Smooth Gentle Skin Cleanser Triclosan SOLUTION TOPICAL 20060901 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. TRICLOSAN .003 L/L 47593-454_a191b382-9a23-42ef-a04e-dec63f1dde78 47593-454 HUMAN OTC DRUG Non-Aerosol Antimicrobial Foam Hand Rub Antiseptic handwash SOLUTION TOPICAL 20080115 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. BENZALKONIUM CHLORIDE .1 mL/100mL 47593-457_feb7e535-09ef-4d86-903c-5330377d2769 47593-457 HUMAN OTC DRUG Quik-Care Antiseptic Handwash ALCOHOL SOLUTION TOPICAL 20081029 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 62 mL/100mL 47593-458_98e3aa83-0d05-4b0d-81c8-e3d4a26c55f3 47593-458 HUMAN OTC DRUG Quik-Care Alcohol SOLUTION TOPICAL 20090116 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 620 mg/mL 47593-459_73351e99-d34d-4f80-ae08-eae4d91c4468 47593-459 HUMAN OTC DRUG Ecolab Facilipro triclosan SOLUTION TOPICAL 20080904 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL 47593-462_28f7e1db-ec80-4095-a32e-e3d7c2ff3862 47593-462 HUMAN OTC DRUG Keystone Antibacterial Triclosan SOLUTION TOPICAL 20091111 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL 47593-465_b8d5a1b3-930c-493c-bdee-7b2214d8aa79 47593-465 HUMAN OTC DRUG Ecolab Keystone Chloroxylenol SOLUTION TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 5 mg/mL 47593-466_27bccd8f-c4e6-4c73-b68a-682c5b5ac521 47593-466 HUMAN OTC DRUG Keystone Liquid Hand Sanitizer Alcohol SOLUTION TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 534 mg/mL 47593-467_af7d1957-c8c1-42b6-9e49-0e2a93ec087e 47593-467 HUMAN OTC DRUG Facilipro Hand Sanitizer Alcohol SOLUTION TOPICAL 20101203 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 620 mg/mL 47593-468_38557480-304e-4466-9d50-5bc72d143d37 47593-468 HUMAN OTC DRUG Pureforce triclosan SOLUTION TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mL/100mL 47593-469_e683471b-def5-4551-ba6f-f75a29c92d61 47593-469 HUMAN OTC DRUG Ecolab Triclosan SOLUTION TOPICAL 20110124 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mL/100mL 47593-470_219a9bb0-e2d0-47ee-b7b3-5047d56205bd 47593-470 HUMAN OTC DRUG Foodservice Foam Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20101208 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE .1 mL/100mL 47593-471_0adb9f78-36ec-45c0-a33c-62619ea15456 47593-471 HUMAN OTC DRUG Ecolab Triclosan SOLUTION TOPICAL 20110211 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mL/100mL 47593-472_73296054-df90-42f5-8f7b-9a1721701f5d 47593-472 HUMAN OTC DRUG Ecolab Alcohol SOLUTION TOPICAL 20101116 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 62 mL/100mL 47593-473_5b5befeb-804c-42a4-b7b7-65029e7c58ab 47593-473 HUMAN OTC DRUG Pureforce Alcohol SOLUTION TOPICAL 20110427 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 60 mL/100mL 47593-474_50a0c55c-8c46-4783-98d5-c5cc489c523c 47593-474 HUMAN OTC DRUG Facilipro Waterless Hand Rinse Alcohol SOLUTION TOPICAL 20110418 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 70 mL/100mL 47593-476_969ea6f6-ce84-4a51-b353-877404a39272 47593-476 HUMAN OTC DRUG Proforce Commercial Products triclosan SOLUTION TOPICAL 20110325 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mL/100mL 47593-477_f6fdfc63-89bb-449f-bbd9-1ffad3d1313a 47593-477 HUMAN OTC DRUG Sysco Reliance chloroxylenol SOLUTION TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL .5 mL/100mL 47593-478_e44d8ea1-6988-4444-aa34-01483788fc25 47593-478 HUMAN OTC DRUG Reliance Hand Saniziter Benzalkonium chloride SOLUTION TOPICAL 20110330 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE .1 mL/100mL 47593-479_5af2a466-2acc-4374-bd1a-c3c778569808 47593-479 HUMAN OTC DRUG Sysco chloroxylenol SOLUTION TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL .5 mL/100mL 47593-480_e1a46201-748d-467a-8001-bd3a426fd048 47593-480 HUMAN OTC DRUG Sysco Reliance alcohol SOLUTION TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 60 mL/100mL 47593-483_cd8cce3a-015f-4432-9088-7c5c4a0ded23 47593-483 HUMAN OTC DRUG ECOLAB Povidone Iodine SOLUTION TOPICAL 20110624 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. POVIDONE-IODINE 7.5 mL/100mL 47593-484_e64b80ca-065e-4d94-91fc-de557ff66897 47593-484 HUMAN OTC DRUG ECOLAB Povidone Iodine SOLUTION TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. POVIDONE-IODINE 7.5 mL/100mL 47593-485_d2844a4f-d8da-4a78-a1e8-6ed0e23082c1 47593-485 HUMAN OTC DRUG Ecolab Triclosan SOLUTION TOPICAL 20130425 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 10.3 mg/mL 47593-487_f9673d6e-7ad5-4a27-8a5d-e7b5b57ab350 47593-487 HUMAN OTC DRUG Ecolab Alcohol SOLUTION TOPICAL 20121128 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 589.4 mg/mL 47593-488_804df882-c852-461c-a5ec-f2547f46bf88 47593-488 HUMAN OTC DRUG Ecolab Alcohol SOLUTION TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 540.02 mg/mL 47593-491_36b77c0c-a60a-48b6-aac6-77811ad0e85d 47593-491 HUMAN OTC DRUG Quik-Care Ethyl Alcohol SOLUTION TOPICAL 20130619 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 539.71 mg/mL 47593-492_576a5610-0366-4a59-b1ce-02e7c8c412e9 47593-492 HUMAN OTC DRUG Ecolab Benzalkonium Chloride SOLUTION TOPICAL 20111011 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 4.7 mg/mL 47593-495_679ddc51-1d0c-4e2f-99e0-3f4d4e875440 47593-495 HUMAN OTC DRUG PureForce Chloroxylenol SOLUTION TOPICAL 20120823 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 5.25 mg/mL 47593-496_74100f82-1845-46f4-a36e-35c1b569531b 47593-496 HUMAN OTC DRUG PureForce Benzalkonium SOLUTION TOPICAL 20120823 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 1 mg/mL 47593-497_a6bb7f93-da60-44d5-9cad-27023fdd0722 47593-497 HUMAN OTC DRUG PureForce Chloroxylenol SOLUTION TOPICAL 20120727 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 5.2 mg/mL 47593-498_92339e08-75e0-46ce-9f55-8ab45012c9a4 47593-498 HUMAN OTC DRUG PureForce Alcohol SOLUTION TOPICAL 20120823 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 534 mg/mL 47593-499_436a663a-83f3-483a-bc77-7acdbc767b61 47593-499 HUMAN OTC DRUG Clean Strike Triclosan SOLUTION TOPICAL 20120619 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3.06 mg/mL 47593-500_0cff0021-5fd6-4331-8e7b-61af52eb82d8 47593-500 HUMAN OTC DRUG Quik-Care Alcohol SOLUTION TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 539.4 mg/mL 47593-501_ffad104d-3465-4837-88ab-0ab0e2faf71c 47593-501 HUMAN OTC DRUG Ecolab Chloroxylenol SOLUTION TOPICAL 20121024 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 5.2 mg/mL 47593-502_5b2a344c-c2a9-49f9-b39a-e1902a35dea7 47593-502 HUMAN OTC DRUG Ecolab Alcohol SOLUTION TOPICAL 20130326 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 598.5 mg/mL 47593-503_f5b6ddb2-b770-4c77-850b-8ab2c51015cb 47593-503 HUMAN OTC DRUG Ecolab Inc. Chloroxylenol LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 5 mg/mL 47593-504_2aa4c526-daea-4661-bdd7-5315a16f6a3c 47593-504 HUMAN OTC DRUG Pure Force Benzalkonium chloride LIQUID TOPICAL 20131028 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 1 mg/mL 47593-505_930a89c8-655e-4f9b-bc42-0a751cecd78a 47593-505 HUMAN OTC DRUG Ecolab Chloroxylenol LIQUID TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 5 mg/mL 47593-506_d638976a-5bf4-49f5-aca1-38e8161cf8b9 47593-506 HUMAN OTC DRUG Ecolab Chloroxylenol LIQUID TOPICAL 20140321 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 10 mg/mL 47593-507_498f08f3-f0b4-454c-8853-1155f7dc91b9 47593-507 HUMAN OTC DRUG Ecolab Alcohol LIQUID TOPICAL 20131031 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 534 mg/mL 47593-508_a7e7c231-d27c-4f67-8dff-6badaf04ab93 47593-508 HUMAN OTC DRUG Ecolab Facilipro Alcohol LIQUID TOPICAL 20140202 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 534 mg/mL 47593-509_41407093-f49e-4a66-9e9c-1910a36d95a0 47593-509 HUMAN OTC DRUG Ecolab Alcohol LIQUID TOPICAL 20140305 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 700 mg/mL 47593-521_91a008c8-6230-4b0a-b0a7-56f5e2d5fc77 47593-521 HUMAN OTC DRUG Ecolab Benzalkonium chloride SOLUTION TOPICAL 20140915 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 5.5 mg/mL 47632-0003_f2aaddbc-d0c0-4dd4-b7a5-828d5c764fd0 47632-0003 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19881215 UNAPPROVED MEDICAL GAS O.E. Meyer Company NITROGEN 99 L/100L 47632-0025_920551f0-0157-45bd-a9da-0590cdcdef67 47632-0025 HUMAN PRESCRIPTION DRUG AIR COMPRESSED AIR COMPRESSED GAS RESPIRATORY (INHALATION) 19881215 UNAPPROVED MEDICAL GAS O.E. Meyer Company OXYGEN 20 L/100L 47632-0029_8598ef1f-4179-415c-9288-19a668b0cc6e 47632-0029 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19881215 UNAPPROVED MEDICAL GAS O.E. Meyer Company OXYGEN 99 L/100L 47632-0030_8598ef1f-4179-415c-9288-19a668b0cc6e 47632-0030 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19881215 UNAPPROVED MEDICAL GAS O.E. Meyer Company OXYGEN 99 L/100L 47649-4001_2f90d863-9923-4d28-babb-607dc837c776 47649-4001 HUMAN OTC DRUG BlancTis Essence tooth whitening gel alcohol GEL, DENTIFRICE DENTAL 20100305 UNAPPROVED DRUG OTHER Nibec Co., Ltd ALCOHOL 500 mg/g 47649-5001_b4f9db92-48ae-45e3-aa65-2a4a8b1002e8 47649-5001 HUMAN OTC DRUG BlancTis Forte II tooth whitening alcohol GEL, DENTIFRICE DENTAL 20100724 UNAPPROVED DRUG OTHER Nibec Co., Ltd ALCOHOL 500 mg/g 47649-6001_08fdadfe-416f-42ff-931e-59d8f946d40f 47649-6001 HUMAN OTC DRUG O BlancTis alcohol GEL, DENTIFRICE DENTAL 20120207 UNAPPROVED DRUG OTHER Nibec Co., Ltd ALCOHOL 50 g/100g 47649-7001_ef3e9c6f-c885-49ae-90df-6cb6c6bce8d6 47649-7001 HUMAN OTC DRUG BlancTis Clinic (10%) Sodium Fluoride GEL, DENTIFRICE DENTAL 20131210 OTC MONOGRAPH FINAL part355 Nibec Co., Ltd SODIUM FLUORIDE .25 g/100g 47649-8001_2ba99744-52ac-469c-be42-06afa7319e59 47649-8001 HUMAN OTC DRUG BlancTis Clinic (15%) Sodium Fluoride GEL, DENTIFRICE DENTAL 20131210 OTC MONOGRAPH FINAL part355 Nibec Co., Ltd SODIUM FLUORIDE .25 g/100g 47649-9001_27a3feed-fe7c-4df8-82d6-3c47e5f16809 47649-9001 HUMAN OTC DRUG Dr. Whitiss (8.3%) CARBAMIDE PEROXIDE GEL, DENTIFRICE DENTAL 20140711 OTC MONOGRAPH NOT FINAL part356 Nibec Co., Ltd CARBAMIDE PEROXIDE .083 g/g 47682-001_f98e733b-ea73-4dc9-8478-6a12ba54fa29 47682-001 HUMAN OTC DRUG Green Guard Advanced Sinus Relief ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 47682-002_3793b265-bbb8-4124-9885-5dcb4e1cf4a2 47682-002 HUMAN OTC DRUG Green Guard Advanced Sinus Relief ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 47682-003_80c23d67-0794-46e4-b888-7b8ead563c4c 47682-003 HUMAN OTC DRUG Green Guard Pain and Ache Relief ACETAMINOPHEN, ASPIRIN, SALICYLAMIDE and CAFFEINE TABLET ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE; SALICYLAMIDE 110; 162; 32.4; 152 mg/1; mg/1; mg/1; mg/1 47682-004_c7a2573a-5dd6-4161-82d1-a888051e4fd4 47682-004 HUMAN OTC DRUG Green Guard Sore Throat Relief HEXYLRESORCINOL, MENTHOL LOZENGE ORAL 20081230 20150126 OTC MONOGRAPH NOT FINAL part356 Unifirst First Aid Corporation HEXYLRESORCINOL; MENTHOL 2.4; 4.5 mg/1; mg/1 47682-006_0844556b-c3db-4ced-9faf-f2c32c56ade9 47682-006 HUMAN OTC DRUG Green Guard Cough and Cold Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 47682-007_1b780fb3-c972-4598-bb98-f9144150f005 47682-007 HUMAN OTC DRUG Green Guard Stomach Relief calcium carbonate TABLET, CHEWABLE ORAL 20081230 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 47682-008_04aa0e8d-8e96-4b70-9d95-0d8caeb5bfb5 47682-008 HUMAN OTC DRUG Green Guard Stomach Relief calcium carbonate TABLET, CHEWABLE ORAL 20081230 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 47682-009_da360d0c-4587-433e-aefa-f90a813e0f9b 47682-009 HUMAN OTC DRUG Green Guard Maximum Non-Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 500 mg/1 47682-010_9704b928-3bfc-4825-a44c-c54376fb0ee7 47682-010 HUMAN OTC DRUG Green Guard Maximum Non-Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 500 mg/1 47682-014_09cc5c22-4a05-504e-e054-00144ff8d46c 47682-014 HUMAN OTC DRUG Green Guard Ibupro Relief Ibuprofen TABLET, FILM COATED ORAL 20081230 ANDA ANDA075139 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 47682-016_8d9c0a88-1765-4f44-9be3-6df206ebf67e 47682-016 HUMAN OTC DRUG Green Guard PMS Relief ACETAMINOPHEN, PAMABROM TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN; PAMABROM 325; 25 mg/1; mg/1 47682-017_69b5783c-06d2-47d0-b946-b853cd4dea29 47682-017 HUMAN OTC DRUG Green Guard Allergy 2 Relief PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 47682-018_2e5e6502-20c4-40c5-8749-255908dbd6e3 47682-018 HUMAN OTC DRUG Green Guard Cough Drop Relief Menthol LOZENGE ORAL 20111101 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation MENTHOL 7.6 mg/1 47682-019_d4574ef5-fb23-4a92-9165-a3e132505f1d 47682-019 HUMAN OTC DRUG Green Guard Sterile Alcohol Pads Isopropyl Alcohol LIQUID TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation ISOPROPYL ALCOHOL .7 mL/mL 47682-020_7eb92aee-1a96-4770-9ec1-827fb7502844 47682-020 HUMAN OTC DRUG Benzocaine Benzocaine SWAB TOPICAL 20140826 OTC MONOGRAPH FINAL part348 Unifirst First Aid Corporation BENZOCAINE 60 mg/mL 47682-027_39f9b531-dc8a-478a-86ae-1d9c6a2993c6 47682-027 HUMAN OTC DRUG Green Guard Stomach Relief calcium carbonate TABLET, CHEWABLE ORAL 20140615 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 47682-050_38cc7bdb-a367-46d4-8127-71e80fc1f822 47682-050 HUMAN OTC DRUG MEDIQUE Medikoff Drops MENTHOL LOZENGE ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation MENTHOL 7.6 mg/1 47682-073_c53078c7-0530-4ca2-b000-2d01461b751c 47682-073 HUMAN OTC DRUG MEDIQUE Back Pain Off Magnesium Salicylate/Acetaminophen/Caffeine TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN; CAFFEINE; MAGNESIUM SALICYLATE 250; 50; 290 mg/1; mg/1; mg/1 47682-088_53420d58-0eef-45e7-9b10-3a231c8dc2d4 47682-088 HUMAN OTC DRUG Medique Alcalak calcium carbonate TABLET, CHEWABLE ORAL 20081230 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 47682-089_53420d58-0eef-45e7-9b10-3a231c8dc2d4 47682-089 HUMAN OTC DRUG Medi First Antacid calcium carbonate TABLET, CHEWABLE ORAL 20081230 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 47682-092_53420d58-0eef-45e7-9b10-3a231c8dc2d4 47682-092 HUMAN OTC DRUG Medi First Plus Antacid calcium carbonate TABLET, CHEWABLE ORAL 20081230 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 47682-097_ea7ad75e-257c-4846-9f97-a0731eb9244c 47682-097 HUMAN OTC DRUG MEDIQUE Aspirin Aspirin TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part343 Unifirst First Aid Corporation ASPIRIN 325 mg/1 47682-098_ea7ad75e-257c-4846-9f97-a0731eb9244c 47682-098 HUMAN OTC DRUG MEDI-FIRST Aspirin Aspirin TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part343 Unifirst First Aid Corporation ASPIRIN 325 mg/1 47682-099_ea7ad75e-257c-4846-9f97-a0731eb9244c 47682-099 HUMAN OTC DRUG Medi First Plus Aspirin Aspirin TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part343 Unifirst First Aid Corporation ASPIRIN 325 mg/1 47682-100_7849f5d7-f093-4407-8b03-9da528d1da3d 47682-100 HUMAN OTC DRUG MEDIQUE I-PRIN Ibuprofen TABLET, FILM COATED ORAL 20081230 ANDA ANDA075139 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 47682-101_614b889f-765a-4a83-ad04-eface3f5ede9 47682-101 HUMAN OTC DRUG Medique Alcalak calcium carbonate TABLET, CHEWABLE ORAL 20081230 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 47682-102_b91b99bd-65ab-4ec7-ab48-1b925e13c197 47682-102 HUMAN OTC DRUG Medique Onset Forte ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 20160101 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 162.5; 2; 5 mg/1; mg/1; mg/1 47682-110_44f44824-7edb-4f9c-92db-65542682e618 47682-110 HUMAN OTC DRUG Medique Sugar Free Medikoff Drops Menthol LOZENGE ORAL 20111101 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation MENTHOL 5.8 mg/1 47682-112_c5bad8f0-a536-4345-b939-9d20357c6fff 47682-112 HUMAN OTC DRUG MEDIQUE APAP Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 325 mg/1 47682-113_c5bad8f0-a536-4345-b939-9d20357c6fff 47682-113 HUMAN OTC DRUG MEDI-FIRST Non-Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 325 mg/1 47682-114_c5bad8f0-a536-4345-b939-9d20357c6fff 47682-114 HUMAN OTC DRUG Medi First Plus Non-Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 325 mg/1 47682-115_c5bad8f0-a536-4345-b939-9d20357c6fff 47682-115 HUMAN OTC DRUG Dover Aminophen Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 325 mg/1 47682-120_a3f9ef3a-9e87-482e-b498-f7a5db3af5f4 47682-120 HUMAN OTC DRUG Medique Medicidin D ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 47682-125_1ffc763c-bb3f-4c49-9858-d5d1452804ff 47682-125 HUMAN OTC DRUG MEDIQUE APAP Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 500 mg/1 47682-126_1ffc763c-bb3f-4c49-9858-d5d1452804ff 47682-126 HUMAN OTC DRUG MEDI-FIRST Non-Aspirin Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 500 mg/1 47682-127_1ffc763c-bb3f-4c49-9858-d5d1452804ff 47682-127 HUMAN OTC DRUG Medi First Plus Non-Aspirin Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 500 mg/1 47682-135_75161581-9df0-4c7b-9e67-0170fe8bdab5 47682-135 HUMAN OTC DRUG Medique Medi Seltzer ASPIRIN, CITRIC ACID, SODIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20081230 OTC MONOGRAPH FINAL part343 Unifirst First Aid Corporation ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 47682-138_5e856d83-4d3b-41a3-82c0-5cdbf1181681 47682-138 HUMAN OTC DRUG Medique Decorel Forte Plus ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 47682-139_5e856d83-4d3b-41a3-82c0-5cdbf1181681 47682-139 HUMAN OTC DRUG Medi-First Cold Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 47682-145_4ee20575-e740-4e86-84e1-3989aba35ce9 47682-145 HUMAN OTC DRUG MEDIQUE APAP Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 325 mg/1 47682-146_d4c9baa0-e500-4fb7-a417-bc876d95f1a9 47682-146 HUMAN OTC DRUG Medi First Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 47682-148_d4c9baa0-e500-4fb7-a417-bc876d95f1a9 47682-148 HUMAN OTC DRUG Otis Clapp Mygrex ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 47682-158_d4c9baa0-e500-4fb7-a417-bc876d95f1a9 47682-158 HUMAN OTC DRUG Medi First Plus Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 47682-159_5e856d83-4d3b-41a3-82c0-5cdbf1181681 47682-159 HUMAN OTC DRUG Medi-First Plus Cold Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 47682-161_c3a8cf64-564e-48b3-8795-cca82d52a54c 47682-161 HUMAN OTC DRUG Medique Medi-Phenyl PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 47682-162_c3a8cf64-564e-48b3-8795-cca82d52a54c 47682-162 HUMAN OTC DRUG Dover Sudanyl PE PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 47682-164_f5324d8e-4710-48d5-a9f1-e64b63f61220 47682-164 HUMAN OTC DRUG Medique Chlorphen CHLORPHENIRAMINE MALEATE TABLET ORAL 20111001 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation CHLORPHENIRAMINE MALEATE 4 mg/1 47682-165_bffa8a42-a4d2-4925-b160-8bd6df7cdaca 47682-165 HUMAN OTC DRUG Medique Diotame Bismuth Subsalicylate SUSPENSION ORAL 20110405 OTC MONOGRAPH FINAL part335 Unique First Aid Corporation BISMUTH SUBSALICYLATE 262 mg/15mL 47682-167_b699bdf4-66f5-4ddb-9908-1f0dd959d771 47682-167 HUMAN OTC DRUG Medique Diphen DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120101 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 47682-168_454d934d-8067-43be-9885-189c4d372e3f 47682-168 HUMAN OTC DRUG Medique CCP Caffeine Free ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20110801 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 47682-170_d9eedb00-f9d4-4c40-8569-7e9ad34902b9 47682-170 HUMAN OTC DRUG Medi-First Sinus Decongestant PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20120102 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 47682-175_662feebc-f213-42d2-8990-1d862f013093 47682-175 HUMAN OTC DRUG MEDIQUE APAP Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 500 mg/1 47682-184_b699bdf4-66f5-4ddb-9908-1f0dd959d771 47682-184 HUMAN OTC DRUG Medique Diphen DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120101 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 47682-189_a385111f-1557-4bd8-a590-fe3b7edd5335 47682-189 HUMAN OTC DRUG Medique Medicidin D ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20120319 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 47682-190_a385111f-1557-4bd8-a590-fe3b7edd5335 47682-190 HUMAN OTC DRUG Otis Clapp Valihist ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20120319 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 47682-198_3c45f29c-81ea-4884-9174-ba1f36ec4405 47682-198 HUMAN OTC DRUG Medi-First First Aid Eye Wash Water SOLUTION OPHTHALMIC 20111202 OTC MONOGRAPH FINAL part349 Unifirst First Aid Corporation WATER .983 mg/mL 47682-199_9cc6e8e0-08a4-41dd-a195-f828825d2862 47682-199 HUMAN OTC DRUG Medi-First Eyewash Water SOLUTION OPHTHALMIC 20140501 OTC MONOGRAPH FINAL part349 Unifirst First Aid Corporation WATER .929 g/946mL 47682-200_e4213471-4184-45db-af82-d9138e763e14 47682-200 HUMAN OTC DRUG MEDIQUE Diamode Loperamide Hydrochloride TABLET, FILM COATED ORAL 20081230 ANDA ANDA074091 Unifirst First Aid Corporation LOPERAMIDE HYDROCHLORIDE 2 mg/1 47682-201_d5880d7b-898b-44c1-a861-16ba7dbc5564 47682-201 HUMAN OTC DRUG Medique Alcalak calcium carbonate TABLET, CHEWABLE ORAL 20140615 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 47682-203_301eefde-db27-498f-a011-ebf3a8a67bbd 47682-203 HUMAN OTC DRUG MEDIQUE Loradamed Loratadine TABLET, FILM COATED ORAL 20081230 ANDA ANDA076134 Unifirst First Aid Corporation LORATADINE 10 mg/1 47682-209_7849f5d7-f093-4407-8b03-9da528d1da3d 47682-209 HUMAN OTC DRUG MEDIQUE I-PRIN Ibuprofen TABLET, FILM COATED ORAL 20120625 ANDA ANDA091237 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 47682-210_06f94a65-dff6-3b30-e054-00144ff88e88 47682-210 HUMAN OTC DRUG Medique Diotame BISMUTH SUBSALICYLATE TABLET, CHEWABLE ORAL 20140401 OTC MONOGRAPH FINAL part335 Unifirst First Aid Corporation BISMUTH SUBSALICYLATE 262 mg/1 47682-211_c065512c-2400-417b-94a8-f870a30721c4 47682-211 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation HYDROCORTISONE 10 mg/g 47682-213_29d1529e-ef77-42a0-aa46-0bc18abfbd24 47682-213 HUMAN OTC DRUG Medi-first Burn First Aid benzethonium chloride, benzocaine, and menthol AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BENZETHONIUM CHLORIDE; BENZOCAINE; MENTHOL 170; 8500; 281 mg/85g; mg/85g; mg/85g 47682-214_80858e35-7c72-412c-ab54-326416d73fd7 47682-214 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20120222 OTC MONOGRAPH NOT FINAL part333E Unifirst First Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL 47682-215_2f8931aa-51f7-483a-af52-e2d279b4934e 47682-215 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part333E Unifirst First Aid Corporation BENZALKONIUM CHLORIDE .0013 g/mL 47682-217_0998162e-d415-4653-8f9a-6df00349b558 47682-217 HUMAN OTC DRUG Medique Guaicon DMS Guaifenesin, Dextromethorphan Hbr SYRUP ORAL 20110405 OTC MONOGRAPH FINAL part341 UNIFIRST FIRST AID CORPORATION DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 47682-220_07d585ce-389d-349a-e054-00144ff8d46c 47682-220 HUMAN OTC DRUG Medique Diotame BISMUTH SUBSALICYLATE TABLET, CHEWABLE ORAL 20081230 20170722 OTC MONOGRAPH FINAL part335 Unifirst First Aid Corporation BISMUTH SUBSALICYLATE 262 mg/1 47682-221_9d1c9851-2796-4e0a-bc7c-f078a52a32ff 47682-221 HUMAN OTC DRUG Medi-First Sterile Alcohol Pads Isopropyl Alcohol LIQUID TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation ISOPROPYL ALCOHOL .7 mL/mL 47682-223_3130b4f3-4eaf-4d51-8328-fc949ec0db89 47682-223 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20130425 OTC MONOGRAPH FINAL part333B Unifirst First Aid Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 47682-225_c73f56e5-00af-4476-a675-52455c44d7ae 47682-225 HUMAN OTC DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SPRAY TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation LIDOCAINE HYDROCHLORIDE 20 g/L 47682-226_a670852b-93b4-4857-b2b2-9d795ed160b6 47682-226 HUMAN OTC DRUG Blood Clotting First Aid benzethonium chloride and lidocaine AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BENZETHONIUM CHLORIDE; LIDOCAINE 170; 3400 mg/85g; mg/85g 47682-228_484970fe-13ef-4bd7-acea-4a11f7321ae2 47682-228 HUMAN OTC DRUG Medique Pain Off ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 47682-229_01719e41-a8b4-4b4d-b67a-d5cb13ea9681 47682-229 HUMAN OTC DRUG Antifungal tolnaftate CREAM TOPICAL 20020630 OTC MONOGRAPH FINAL part333C Unifirst First Aid Corporation TOLNAFTATE 10 mg/g 47682-231_ea0d209b-3821-42bf-8ace-a75c58a0b441 47682-231 HUMAN OTC DRUG Antiseptic alcohol, lidocaine hydrochloride LIQUID TOPICAL 20120306 OTC MONOGRAPH NOT FINAL part333E Unifirst First Aid Corporation ALCOHOL; LIDOCAINE HYDROCHLORIDE 500; 20 mg/g; mg/g 47682-237_c86bb49a-042c-4423-89c0-b49b343b4ea7 47682-237 HUMAN OTC DRUG Medique Mediproxen NAPROXEN SODIUM TABLET, FILM COATED ORAL 20081230 ANDA ANDA079096 Unifirst First Aid Corporation NAPROXEN SODIUM 220 mg/1 47682-244_f935d901-e4ae-4775-89c3-3e9f4451635e 47682-244 HUMAN OTC DRUG Antiseptic benzalkonium chloride, benzocaine SPRAY TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation BENZALKONIUM CHLORIDE; BENZOCAINE .96; 58.5 g/L; g/L 47682-247_513feac4-abae-4fdf-80b9-831f8688651b 47682-247 HUMAN OTC DRUG Medique Alamag Plus ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE, SILICON DIOXIDE TABLET, CHEWABLE ORAL 20081230 20160401 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE; SILICON DIOXIDE 200; 24; 200; 1 mg/1; mg/1; mg/1; mg/1 47682-257_3ad010d5-0091-467e-848d-ee39e34cc33b 47682-257 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SPRAY TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation HYDROGEN PEROXIDE 43.275 g/L 47682-260_bc49dfd2-4e2a-4294-921c-1c7da2482fbc 47682-260 HUMAN OTC DRUG Burn with Lidocaine Benzalkonium Chloride, Lidocaine Hydrochloride CREAM TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g 47682-268_1ce65993-0c9c-4143-a6d6-94b8645b17ae 47682-268 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SPRAY TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation ISOPROPYL ALCOHOL 550.2 g/L 47682-279_b031993a-4456-43c7-9aa6-797802ea449c 47682-279 HUMAN OTC DRUG Medi-first Antiseptic First Aid benzocaine and benzethonium chloride AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BENZETHONIUM CHLORIDE; BENZOCAINE 170; 8500 mg/85g; mg/85g 47682-285_c9cc1d10-8887-4a1a-b410-68de1256faff 47682-285 HUMAN OTC DRUG Medique Ban-acid Maximum Strength 750 calcium carbonate TABLET, CHEWABLE ORAL 20140701 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 750 mg/1 47682-300_3500357c-b134-4aba-8bf3-3435cb2575bc 47682-300 HUMAN OTC DRUG Green Guard Super Stat Blood Clotting First Aid benzethonium chloride and lidocaine AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BENZETHONIUM CHLORIDE; LIDOCAINE 170; 3400 mg/85g; mg/85g 47682-301_e4b34c65-8abf-445c-b252-f67bf8cbbd05 47682-301 HUMAN OTC DRUG Green Guard Antiseptic First Aid benzocaine and benzethonium chloride AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BENZETHONIUM CHLORIDE; BENZOCAINE 170; 8500 mg/85g; mg/85g 47682-302_534b9037-032f-44db-8a31-b8d1229afe72 47682-302 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20120222 OTC MONOGRAPH NOT FINAL part333E Unifirst First Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/g 47682-303_4ee20575-e740-4e86-84e1-3989aba35ce9 47682-303 HUMAN OTC DRUG Dover Aminophen Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 325 mg/1 47682-304_97950f12-2dc3-4e2a-aa95-37bb0aed7e1c 47682-304 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20131210 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation HYDROGEN PEROXIDE 30 mL/L 47682-307_5d427719-5681-4498-a778-d19bda7d4a4b 47682-307 HUMAN OTC DRUG Dover Coldonyl ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 100; 5 mg/1; mg/1; mg/1 47682-309_7849f5d7-f093-4407-8b03-9da528d1da3d 47682-309 HUMAN OTC DRUG Dover Addaprin Ibuprofen TABLET, FILM COATED ORAL 20120625 ANDA ANDA091237 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 47682-311_1a573f0d-3545-4944-be8a-d0832531f192 47682-311 HUMAN OTC DRUG Green Guard Burn First Aid benzethonium chloride, benzocaine, and menthol AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BENZETHONIUM CHLORIDE; BENZOCAINE; MENTHOL 170; 8500; 281 mg/85g; mg/85g; mg/85g 47682-313_d76938f9-a0ba-4e29-b099-40263bd9b451 47682-313 HUMAN OTC DRUG Green Guard Hydrogen Peroxide First Aid hydrogen peroxide SPRAY, METERED TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part356 Unifirst First Aid Corporation HYDROGEN PEROXIDE 3.54 mL/119mL 47682-314_7849f5d7-f093-4407-8b03-9da528d1da3d 47682-314 HUMAN OTC DRUG Dover Addaprin Ibuprofen TABLET, FILM COATED ORAL 20081230 ANDA ANDA075139 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 47682-392_37a06c09-f5ae-4403-a2fe-0711f6bb3eca 47682-392 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20130412 OTC MONOGRAPH FINAL part333B Unifirst First Aid Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 47682-397_01bdc1a6-de43-4615-8445-0b8f42e5469f 47682-397 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation HYDROCORTISONE 10 mg/g 47682-399_6fd5bbfc-1c8b-4fb7-8514-111fe379d262 47682-399 HUMAN OTC DRUG Derma-Caine Benzalkonium Chloride, Lidocaine Hydrochloride CREAM TOPICAL 20120131 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g 47682-406_070d5713-e000-2913-e054-00144ff8d46c 47682-406 HUMAN OTC DRUG Medi-First Pep-T-Med Bismuth Subsalicylate TABLET, CHEWABLE ORAL 20111201 OTC MONOGRAPH FINAL part335 Unifirst First Aid Corporation BISMUTH SUBSALICYLATE 262 mg/1 47682-409_7849f5d7-f093-4407-8b03-9da528d1da3d 47682-409 HUMAN OTC DRUG Otis Clapp Ultraprin Ibuprofen TABLET, FILM COATED ORAL 20120625 ANDA ANDA091237 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 47682-410_71e396ec-bac0-4219-b902-36a64207b7ed 47682-410 HUMAN OTC DRUG Green Guard First Aid Eye Wash Water SOLUTION OPHTHALMIC 20111202 OTC MONOGRAPH FINAL part349 Unifirst First Aid Corporation WATER .983 mg/mL 47682-411_0e26e3af-7c2e-427c-982a-7d801bc9a368 47682-411 HUMAN OTC DRUG First Aid Eye Wash Water SOLUTION OPHTHALMIC 20140515 OTC MONOGRAPH FINAL part349 Unifirst First Aid Corporation WATER .929 g/946mL 47682-450_a3bdcbf3-41e3-47bc-a2eb-1cbaaf251e1e 47682-450 HUMAN OTC DRUG Medi-first Protective Coating Bandage benzethonium chloride and benzocaine AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation BENZETHONIUM CHLORIDE; BENZOCAINE 170; 2720 mg/85g; mg/85g 47682-456_6521793f-887b-4c7f-ba7b-19bb60887770 47682-456 HUMAN OTC DRUG Bayer Genuine Aspirin Aspirin TABLET, COATED ORAL 20140124 OTC MONOGRAPH FINAL part343 Unifirst First Aid Corporation ASPIRIN 325 mg/1 47682-477_bec69eb0-aad5-4a7b-b35e-4d7e90f8ecf2 47682-477 HUMAN OTC DRUG Medi-First Burn Lidocaine Hydrochloride GEL TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation LIDOCAINE HYDROCHLORIDE 20 mg/g 47682-479_d294e620-37c5-4122-8610-3cfad455a3f8 47682-479 HUMAN OTC DRUG Medique Medi-Meclizine MECLIZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 20160501 OTC MONOGRAPH FINAL part336 Unifirst First Aid Corporation MECLIZINE HYDROCHLORIDE 25 mg/1 47682-480_e03e0e32-9422-4c17-8436-b8b0043f5ebe 47682-480 HUMAN OTC DRUG Medique Medi-Meclizine MECLIZINE HYDROCHLORIDE TABLET ORAL 20130901 OTC MONOGRAPH FINAL part336 Unifirst First Aid Corporation MECLIZINE HYDROCHLORIDE 25 mg/1 47682-487_681a80be-542f-4060-9e43-3c947de438b5 47682-487 HUMAN OTC DRUG Medi-first Ivy-Rid First Aid benzocaine and benzethonium chloride AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BENZETHONIUM CHLORIDE; BENZOCAINE 127.5; 4250 mg/85g; mg/85g 47682-488_9b0be206-47e8-4ee9-97c6-ea99d6db263d 47682-488 HUMAN OTC DRUG Bayer Aleve Naproxen Sodium TABLET ORAL 20140124 NDA NDA020204 Unifirst First Aid Corporation NAPROXEN SODIUM 220 mg/1 47682-502_7849f5d7-f093-4407-8b03-9da528d1da3d 47682-502 HUMAN OTC DRUG Otis Clapp Ultraprin Ibuprofen TABLET, FILM COATED ORAL 20081230 ANDA ANDA075139 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 47682-509_06284e48-3d5e-4529-ba15-faab421b2e9e 47682-509 HUMAN OTC DRUG Otis Clapp Mygrex ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 47682-511_e6d2e92b-0353-45bc-a4fa-3f0e8c70ad31 47682-511 HUMAN OTC DRUG Hand Sanitizer alcohol GEL TOPICAL 20130409 OTC MONOGRAPH NOT FINAL part333E Unifirst First Aid Corporation ALCOHOL 540.26 g/L 47682-522_1ef6d566-64c3-4ecc-b11a-d952f010de93 47682-522 HUMAN OTC DRUG Hand Sanitizer benzalkonium chloride LIQUID TOPICAL 20130409 OTC MONOGRAPH NOT FINAL part333E Unifirst First Aid Corporation BENZALKONIUM CHLORIDE .0039 mg/mL 47682-543_a3f9ef3a-9e87-482e-b498-f7a5db3af5f4 47682-543 HUMAN OTC DRUG Otis Clapp Valihist ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 47682-578_29af4903-cb9f-4319-84f1-290df7a85033 47682-578 HUMAN OTC DRUG Otis Clapp Femcaps ACETAMINOPHEN, PAMABROM TABLET, FILM COATED ORAL 20081230 20150310 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN; PAMABROM 325; 25 mg/1; mg/1 47682-581_39a1cff1-21e0-4a7d-8277-d64daf2ae9d9 47682-581 HUMAN OTC DRUG Medi-First Medi-First OINTMENT TOPICAL 20091020 OTC MONOGRAPH FINAL part333A Medique Products BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [USP'U]/1; mg/1; [USP'U]/1 47682-587_8bc58a1c-60fd-45fc-bb24-4739db782d49 47682-587 HUMAN OTC DRUG Otis Clapp Back Quell MAGNESIUM SALICYLATE, ACETAMINOPHEN TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN; MAGNESIUM SALICYLATE 200; 200 mg/1; mg/1 47682-681_a6d42352-cb10-4321-bd7d-b5b328089c70 47682-681 HUMAN OTC DRUG Medi-First Medi-First CREAM TOPICAL 20091020 OTC MONOGRAPH NOT FINAL part346 Medique Products HYDROCORTISONE .009 g/1 47682-700_0607edb0-1b3b-2ccd-e054-00144ff8d46c 47682-700 HUMAN OTC DRUG Medique Iprin Ibuprofen TABLET, COATED ORAL 20141117 ANDA ANDA079174 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 47682-702_0607edb0-1b3b-2ccd-e054-00144ff8d46c 47682-702 HUMAN OTC DRUG Otis Clapp Ultraprin Ibuprofen TABLET, COATED ORAL 20141117 ANDA ANDA079174 Unifirst First Aid Corporation IBUPROFEN 262 mg/1 47682-708_0607edb0-1b3b-2ccd-e054-00144ff8d46c 47682-708 HUMAN OTC DRUG Medi-First Ibuprofen Ibuprofen TABLET, COATED ORAL 20141117 ANDA ANDA079174 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 47682-709_0607edb0-1b3b-2ccd-e054-00144ff8d46c 47682-709 HUMAN OTC DRUG Medi-First Plus Ibuprofen Ibuprofen TABLET, COATED ORAL 20141117 ANDA ANDA079174 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 47682-710_0798e401-8248-2fce-e054-00144ff8d46c 47682-710 HUMAN OTC DRUG Green Guard Ibuprofen Relief Ibuprofen TABLET, COATED ORAL 20141117 ANDA ANDA079174 Unifirst First Aid IBUPROFEN 200 mg/1 47682-714_0607edb0-1b3b-2ccd-e054-00144ff8d46c 47682-714 HUMAN OTC DRUG Dover Addaprin Ibuprofen TABLET, COATED ORAL 20141117 ANDA ANDA079174 Unifirst First Aid Corporation IBUPROFEN 262 mg/1 47682-802_614b889f-765a-4a83-ad04-eface3f5ede9 47682-802 HUMAN OTC DRUG Medi First Antacid calcium carbonate TABLET, CHEWABLE ORAL 20081230 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 47682-803_4ee20575-e740-4e86-84e1-3989aba35ce9 47682-803 HUMAN OTC DRUG MEDI-FIRST Non-Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 325 mg/1 47682-804_662feebc-f213-42d2-8990-1d862f013093 47682-804 HUMAN OTC DRUG MEDI-FIRST Non-Aspirin Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 500 mg/1 47682-808_7849f5d7-f093-4407-8b03-9da528d1da3d 47682-808 HUMAN OTC DRUG MEDI-FIRST Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20081230 ANDA ANDA075139 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 47682-809_daa7e7ef-8ff6-4faf-8bd4-e4d63d914b20 47682-809 HUMAN OTC DRUG Medi-First Sinus Decongestant PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 47682-810_29af4903-cb9f-4319-84f1-290df7a85033 47682-810 HUMAN OTC DRUG Medi First Cramp ACETAMINOPHEN, PAMABROM TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN; PAMABROM 325; 25 mg/1; mg/1 47682-811_1e1fc770-554f-4811-9bf0-5d880988a3cb 47682-811 HUMAN OTC DRUG Medi First Pain Relief ACETAMINOPHEN, ASPIRIN, SALICYLAMIDE and CAFFEINE TABLET ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE; SALICYLAMIDE 110; 162; 32.4; 152 mg/1; mg/1; mg/1; mg/1 47682-815_38cc7bdb-a367-46d4-8127-71e80fc1f822 47682-815 HUMAN OTC DRUG MEDI-FIRST Cherry Cough Drops MENTHOL LOZENGE ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation MENTHOL 7.6 mg/1 47682-819_06284e48-3d5e-4529-ba15-faab421b2e9e 47682-819 HUMAN OTC DRUG Medi First Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 47682-820_d5880d7b-898b-44c1-a861-16ba7dbc5564 47682-820 HUMAN OTC DRUG Medi-First Antacid calcium carbonate TABLET, CHEWABLE ORAL 20140615 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 47682-829_7849f5d7-f093-4407-8b03-9da528d1da3d 47682-829 HUMAN OTC DRUG MEDI-FIRST Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20120625 ANDA ANDA091237 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 47682-889_601b73c9-ae2d-4c4b-8b06-507d456322d6 47682-889 HUMAN OTC DRUG Medique Medi-lax BISACODYL TABLET, DELAYED RELEASE ORAL 20081230 OTC MONOGRAPH NOT FINAL part334 Unifirst First Aid Corporation BISACODYL 5 mg/1 47682-902_614b889f-765a-4a83-ad04-eface3f5ede9 47682-902 HUMAN OTC DRUG Medi First Plus Antacid calcium carbonate TABLET, CHEWABLE ORAL 20081230 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 47682-903_4ee20575-e740-4e86-84e1-3989aba35ce9 47682-903 HUMAN OTC DRUG Medi First Plus Non-Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 325 mg/1 47682-904_662feebc-f213-42d2-8990-1d862f013093 47682-904 HUMAN OTC DRUG Medi First Plus Non-Aspirin Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 500 mg/1 47682-908_7849f5d7-f093-4407-8b03-9da528d1da3d 47682-908 HUMAN OTC DRUG MEDI-FIRST PLUS Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20081230 ANDA ANDA075139 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 47682-910_29af4903-cb9f-4319-84f1-290df7a85033 47682-910 HUMAN OTC DRUG Medi First Plus Cramp ACETAMINOPHEN, PAMABROM TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN; PAMABROM 325; 25 mg/1; mg/1 47682-911_1e1fc770-554f-4811-9bf0-5d880988a3cb 47682-911 HUMAN OTC DRUG Medi First Plus Pain Zapper ACETAMINOPHEN, ASPIRIN, SALICYLAMIDE and CAFFEINE TABLET ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE; SALICYLAMIDE 110; 162; 32.4; 152 mg/1; mg/1; mg/1; mg/1 47682-915_38cc7bdb-a367-46d4-8127-71e80fc1f822 47682-915 HUMAN OTC DRUG Medi First Plus Cherry Cough Drops MENTHOL LOZENGE ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation MENTHOL 7.6 mg/1 47682-919_06284e48-3d5e-4529-ba15-faab421b2e9e 47682-919 HUMAN OTC DRUG Medi First Plus Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 47682-920_d5880d7b-898b-44c1-a861-16ba7dbc5564 47682-920 HUMAN OTC DRUG Medi-First Plus Antacid calcium carbonate TABLET, CHEWABLE ORAL 20140615 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 47682-929_7849f5d7-f093-4407-8b03-9da528d1da3d 47682-929 HUMAN OTC DRUG MEDI-FIRST PLUS Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20120625 ANDA ANDA091237 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 47682-931_dfd17ff9-8cc5-4229-91aa-de2707edc50b 47682-931 HUMAN OTC DRUG Medi-First Plus Sterile Alcohol Pads Isopropyl Alcohol LIQUID TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation ISOPROPYL ALCOHOL .7 mL/mL 47682-933_5de6f369-1b2a-4fa8-8a64-3d85af46e71d 47682-933 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation HYDROCORTISONE 10 mg/g 47682-934_5a5a74e1-d320-42dd-b417-f74d698f6b68 47682-934 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20130412 OTC MONOGRAPH FINAL part333B Unifirst First Aid Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 47682-935_5e306db3-aef7-40cb-94bc-95977ec6c100 47682-935 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine OINTMENT TOPICAL 20130920 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BACITRACIN ZINC; LIDOCAINE HYDROCHLORIDE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 40; 3.5; 5000 [USP'U]/g; mg/g; mg/g; [USP'U]/g 47682-936_baebc527-d18f-459a-bf2c-503cb9d34237 47682-936 HUMAN OTC DRUG Medi-First Plus First Aid Eye Wash Water SOLUTION OPHTHALMIC 20111202 OTC MONOGRAPH FINAL part349 Unifirst First Aid Corporation WATER .983 mg/mL 47682-939_473e887b-64ea-4a58-8f4e-f91bd397aec3 47682-939 HUMAN OTC DRUG Burn with Lidocaine Benzalkonium Chloride, Lidocaine Hydrochloride CREAM TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g 47781-100_b48e595c-7f82-47f3-f1ca-27a0a81cb6f9 47781-100 HUMAN PRESCRIPTION DRUG nevirapine nevirapine TABLET ORAL 20120522 ANDA ANDA203176 Alvogen Inc. NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 47781-103_080745f7-627a-3e63-cea0-07a43878e93d 47781-103 HUMAN PRESCRIPTION DRUG IBANDRONATE SODIUM IBANDRONATE SODIUM TABLET ORAL 20140501 ANDA ANDA078998 Alvogen Inc. IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 47781-108_45f05e2e-ec00-9fb8-78ea-9e91bad9d29d 47781-108 HUMAN PRESCRIPTION DRUG Exemestane Exemestane TABLET ORAL 20140725 ANDA ANDA200898 Alvogen Inc. EXEMESTANE 25 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 47781-135_af200175-22ea-e0cb-d5b7-466c642919c6 47781-135 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride Ophthalmic Solution 2%, 10mL Ophthalmic Solution 2%, 10mL Dorzolamide Hydrochloride Ophthalmic Solution 2%, 10mL SOLUTION OPHTHALMIC 20131216 ANDA ANDA091034 ALVOGEN INC. DORZOLAMIDE HYDROCHLORIDE 22.3 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] 47781-136_28d35df3-b0d6-1dad-0bfa-0c257b62c3b2 47781-136 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution Sterile Ophthalmic Solution Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution SOLUTION OPHTHALMIC 20131217 ANDA ANDA091180 ALVOGEN INC. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 22.3; 6.8 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 47781-147_1d137c2c-fd59-4203-8115-b0a25a282bef 47781-147 HUMAN PRESCRIPTION DRUG Gadopentetate dimeglumine Gadopentetate dimeglumine INJECTION INTRAVENOUS 20140224 NDA AUTHORIZED GENERIC NDA019596 Alvogen, Inc GADOPENTETATE DIMEGLUMINE 469.01 mg/mL 47781-147_7a334ed0-990b-4d48-bd67-7273f5451a25 47781-147 HUMAN PRESCRIPTION DRUG Gadopentetate dimeglumine gadopentetate dimeglumine INJECTION INTRAVENOUS 20140224 NDA AUTHORIZED GENERIC NDA021037 Alvogen, Inc GADOPENTETATE DIMEGLUMINE 469.01 mg/mL 47781-204_9de1f30a-1ac9-4a75-86a2-6e73c5d0901e 47781-204 HUMAN PRESCRIPTION DRUG Estradiol Transdermal System Estradiol PATCH TRANSDERMAL 20111220 NDA NDA020375 Alvogen, Inc. ESTRADIOL .025 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 47781-205_9de1f30a-1ac9-4a75-86a2-6e73c5d0901e 47781-205 HUMAN PRESCRIPTION DRUG Estradiol Transdermal System Estradiol PATCH TRANSDERMAL 20111220 NDA NDA020375 Alvogen, Inc. ESTRADIOL .0375 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 47781-206_9de1f30a-1ac9-4a75-86a2-6e73c5d0901e 47781-206 HUMAN PRESCRIPTION DRUG Estradiol Transdermal System Estradiol PATCH TRANSDERMAL 20111220 NDA NDA020375 Alvogen, Inc. ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 47781-207_9de1f30a-1ac9-4a75-86a2-6e73c5d0901e 47781-207 HUMAN PRESCRIPTION DRUG Estradiol Transdermal System Estradiol PATCH TRANSDERMAL 20111220 NDA NDA020375 Alvogen, Inc. ESTRADIOL .06 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 47781-208_9de1f30a-1ac9-4a75-86a2-6e73c5d0901e 47781-208 HUMAN PRESCRIPTION DRUG Estradiol Transdermal System Estradiol PATCH TRANSDERMAL 20111220 NDA NDA020375 Alvogen, Inc. ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 47781-209_9de1f30a-1ac9-4a75-86a2-6e73c5d0901e 47781-209 HUMAN PRESCRIPTION DRUG Estradiol Transdermal System Estradiol PATCH TRANSDERMAL 20111219 NDA NDA020375 Alvogen, Inc. ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 47781-229_5f209d65-6730-ab8e-01d5-bda39850905f 47781-229 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20120117 ANDA ANDA202677 Alvogen, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 47781-230_5f209d65-6730-ab8e-01d5-bda39850905f 47781-230 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20120117 ANDA ANDA202677 Alvogen, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 47781-263_be567caa-3326-31c8-820a-01aefa71e8cc 47781-263 HUMAN PRESCRIPTION DRUG Oxycodone hydrochloride Oxycodone hydrochloride TABLET ORAL 20111103 ANDA ANDA202116 Alvogen, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 47781-264_be567caa-3326-31c8-820a-01aefa71e8cc 47781-264 HUMAN PRESCRIPTION DRUG Oxycodone hydrochloride Oxycodone hydrochloride TABLET ORAL 20111103 ANDA ANDA202116 Alvogen, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 47781-265_be567caa-3326-31c8-820a-01aefa71e8cc 47781-265 HUMAN PRESCRIPTION DRUG Oxycodone hydrochloride Oxycodone hydrochloride TABLET ORAL 20111103 ANDA ANDA202116 Alvogen, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 47781-266_3232eab3-5f88-4c41-bdab-c1fd71e8dfe9 47781-266 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor CAPSULE ORAL 20100118 ANDA ANDA065146 Alvogen, Inc. CEFACLOR 250 mg/1 47781-267_3232eab3-5f88-4c41-bdab-c1fd71e8dfe9 47781-267 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor CAPSULE ORAL 20100118 ANDA ANDA065146 Alvogen, Inc. CEFACLOR 500 mg/1 47781-268_808865a6-5a7d-43b6-a6d9-f13f90cbd0b5 47781-268 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride moxifloxacin hydrochloride TABLET, FILM COATED ORAL 20140129 NDA AUTHORIZED GENERIC NDA021085 Alvogen, Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 47781-296_de59a5d7-087c-4b80-8583-3bf84a737efa 47781-296 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20101110 ANDA ANDA089771 Alvogen, Inc. NITROGLYCERIN .1 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 47781-297_de59a5d7-087c-4b80-8583-3bf84a737efa 47781-297 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20101110 ANDA ANDA089772 Alvogen, Inc. NITROGLYCERIN .2 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 47781-298_de59a5d7-087c-4b80-8583-3bf84a737efa 47781-298 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20101110 ANDA ANDA089773 Alvogen, Inc. NITROGLYCERIN .4 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 47781-299_de59a5d7-087c-4b80-8583-3bf84a737efa 47781-299 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20101110 ANDA ANDA089774 Alvogen, Inc. NITROGLYCERIN .6 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 47781-303_8d339ec9-41d7-69ac-cfd4-648474f6c2a1 47781-303 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 Alvogen Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 47781-306_06f0bea0-961c-7875-2628-a9c70e6d1d8e 47781-306 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Alvogen Inc. NITROFURANTOIN 25 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 47781-307_06f0bea0-961c-7875-2628-a9c70e6d1d8e 47781-307 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Alvogen Inc. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 47781-308_06f0bea0-961c-7875-2628-a9c70e6d1d8e 47781-308 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Alvogen Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 47781-331_1333abef-2b71-3b54-679c-ec20b5047b65 47781-331 HUMAN PRESCRIPTION DRUG Primaquine Phosphate Primaquine Phosphate TABLET, FILM COATED ORAL 20111208 ANDA ANDA203924 Alvogen, Inc. PRIMAQUINE PHOSPHATE 26.3 mg/1 Antimalarial [EPC] 47781-340_0d159914-4c29-45bc-94c4-53a037e9a286 47781-340 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20080130 NDA AUTHORIZED GENERIC NDA020482 Alvogen, Inc. ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 47781-341_0d159914-4c29-45bc-94c4-53a037e9a286 47781-341 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20080130 NDA AUTHORIZED GENERIC NDA020482 Alvogen, Inc. ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 47781-342_0d159914-4c29-45bc-94c4-53a037e9a286 47781-342 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20080130 NDA AUTHORIZED GENERIC NDA020482 Alvogen, Inc. ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 47781-368_e6d04375-aec5-41df-ae7a-8cb87cf32d86 47781-368 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19930421 NDA AUTHORIZED GENERIC NDA020198 Alvogen, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 47781-369_e6d04375-aec5-41df-ae7a-8cb87cf32d86 47781-369 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19930421 NDA AUTHORIZED GENERIC NDA020198 Alvogen, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 47781-370_e6d04375-aec5-41df-ae7a-8cb87cf32d86 47781-370 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19930421 NDA AUTHORIZED GENERIC NDA020198 Alvogen, Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 47781-607_912bdb9b-01f8-a63f-8e3e-ba17116dd5a8 47781-607 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20120831 ANDA ANDA091681 Alvogen Inc. DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] 47781-729_6e57ccc2-867e-5f1b-18fc-7c6078ad3d60 47781-729 HUMAN PRESCRIPTION DRUG vancomycin hydrochloride vancomycin hydrochloride CAPSULE ORAL 20120409 ANDA ANDA065490 Alvogen, Inc. VANCOMYCIN HYDROCHLORIDE 125 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 47781-730_6e57ccc2-867e-5f1b-18fc-7c6078ad3d60 47781-730 HUMAN PRESCRIPTION DRUG vancomycin hydrochloride vancomycin hydrochloride CAPSULE ORAL 20120409 ANDA ANDA065490 Alvogen, Inc. VANCOMYCIN HYDROCHLORIDE 250 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 47783-101_87153ce0-8607-950c-05de-e29d6b3c6f78 47783-101 HUMAN PRESCRIPTION DRUG Kalbitor ecallantide INJECTION, SOLUTION SUBCUTANEOUS 20100202 BLA BLA125277 Dyax Corp. ECALLANTIDE 10 mg/mL 47784-001_fb1962d5-b6a6-4f41-a88d-33c891d5961b 47784-001 HUMAN OTC DRUG SinuClean ECBALLIUM ELATERIUM SOLUTION SPRAY NASAL 20091022 UNAPPROVED HOMEOPATHIC Galsor S.r.l ECBALLIUM ELATERIUM FRUIT 22.09 mL/100mL 47832-205_2d439d76-d59a-4456-9afb-5e187e1e6c93 47832-205 HUMAN OTC DRUG Hydrocortisone Acetate Hydrocortisone Acetate CREAM TOPICAL 20070124 OTC MONOGRAPH NOT FINAL part348 Bentlin Products LLC HYDROCORTISONE ACETATE 10 mg/g 47993-200_448d8025-3f44-4582-90e7-7042e5072bf1 47993-200 HUMAN OTC DRUG HAND SANITIZER ALCOHOL LIQUID TOPICAL 20140503 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL 62 g/100g 47993-200_4fbf9b20-2596-4424-a123-eefb5a3defee 47993-200 HUMAN OTC DRUG HAND SANITIZER ALCOHOL LIQUID TOPICAL 20140503 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL 62 g/100g 47993-200_8e1eee4c-d7d7-4105-9c3e-4546024b8de1 47993-200 HUMAN OTC DRUG HAND SANITIZER ALCOHOL LIQUID TOPICAL 20140503 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL 62 g/100g 47993-200_de5b4c09-5e39-4e32-afec-ee2639a47318 47993-200 HUMAN OTC DRUG HAND SANITIZER ALCOHOL LIQUID TOPICAL 20140503 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL 62 g/100g 47993-200_fbccc24b-0404-4a62-a6d8-2b14cb3ee6a2 47993-200 HUMAN OTC DRUG HAND SANITIZER ALCOHOL LIQUID TOPICAL 20140503 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL 62 g/100g 47993-301_83749051-1008-45cb-a0c2-f972c13a126a 47993-301 HUMAN OTC DRUG HAND SANITIZER WITH VE ALCOHOL LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD .ALPHA.-TOCOPHEROL ACETATE, DL-; ALCOHOL 1.5; 62 g/100g; g/100g 47993-302_9db8eee8-4e02-4c1f-9e0e-5786340c3dcf 47993-302 HUMAN OTC DRUG WHITE HAND SANITIZER HAND SANITIZER LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD .ALPHA.-TOCOPHEROL ACETATE, DL-; ALCOHOL; TITANIUM DIOXIDE .6; 62; .1 g/100g; g/100g; g/100g 47993-303_7494c860-44d9-4aa2-b1a8-3eb1172df0fc 47993-303 HUMAN OTC DRUG WHITE HAND SANITIZER HAND SANITIZER LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD .ALPHA.-TOCOPHEROL ACETATE, DL-; ALCOHOL; TITANIUM DIOXIDE .6; 62; .1 g/100g; g/100g; g/100g 47993-304_b4ebbda9-8929-436e-812a-53f41ee235ed 47993-304 HUMAN OTC DRUG HAND SANITIZER WITH VE ALCOHOL LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD .ALPHA.-TOCOPHEROL ACETATE, DL-; ALCOHOL 1.5; 62 g/100g; g/100g 47993-305_894fb4fc-8d6b-4516-a8b9-647218b15e64 47993-305 HUMAN OTC DRUG HAND SANITIZER WITH VE ALCOHOL LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD .ALPHA.-TOCOPHEROL ACETATE, DL-; ALCOHOL 1.5; 62 g/100g; g/100g 48095-390_a84f370d-5c7e-479a-831a-0cbff527511e 48095-390 HUMAN OTC DRUG Numb Nuts Lidocaine CREAM TOPICAL 20100610 OTC MONOGRAPH FINAL part348 Miss Smarty Pants Enterprises, Inc. LIDOCAINE 4 g/100g 48102-003_722cb3be-8e7a-443f-8770-2aa147b8a131 48102-003 HUMAN PRESCRIPTION DRUG NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT OPHTHALMIC 20110720 ANDA ANDA062938 Fera Pharmaceuticals DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; U/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 48102-004_9c3608ed-b194-4374-af4f-0e46e821c51f 48102-004 HUMAN PRESCRIPTION DRUG POLYCIN BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT OPHTHALMIC 20110720 ANDA ANDA065022 Fera Pharmaceuticals BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 U/g; U/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 48102-005_02ab3f03-ec4c-490a-af6f-b9363c251585 48102-005 HUMAN PRESCRIPTION DRUG NEO-POLYCIN HC NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND HYDROCORTISONE ACETATE OINTMENT OPHTHALMIC 20110701 ANDA ANDA062166 Fera Pharmaceuticals BACITRACIN ZINC; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 10; 3.5; 10000 U/g; mg/g; mg/g; U/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 48102-006_5a2d5634-3d6d-4856-84a9-177c6ede069c 48102-006 HUMAN PRESCRIPTION DRUG NEO-POLYCIN NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT OPHTHALMIC 20110715 ANDA ANDA060764 Fera Pharmaceuticals BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 10000 U/g; mg/g; U/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] 48102-007_76210742-e858-4dc0-a874-1474da845e34 48102-007 HUMAN PRESCRIPTION DRUG BACITRACIN BACITRACIN OINTMENT OPHTHALMIC 20100111 ANDA ANDA061212 Fera Pharmaceuticals BACITRACIN 500 [iU]/g Decreased Cell Wall Synthesis & Repair [PE] 48102-008_dc3ee55d-114e-44f2-adb2-fb0c24eba732 48102-008 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 20100118 ANDA ANDA062447 Fera Pharmaceuticals ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 48102-009_fd22de1a-d4c8-43ff-bbfb-3cf8ce604f10 48102-009 HUMAN PRESCRIPTION DRUG GARAMYCIN GENTAMICIN SULFATE OINTMENT OPHTHALMIC 20101008 ANDA ANDA065024 Fera Pharmaceuticals, LLC GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 48102-012_5cea83a1-652c-44c3-90cf-37556026bfa3 48102-012 HUMAN OTC DRUG STERILUBE OINTMENT PETROLATUM OPHTHALMIC OINTMENT OINTMENT OPHTHALMIC 20100201 OTC MONOGRAPH FINAL part349 Fera Pharmaceuticals MINERAL OIL; PETROLATUM 150; 850 mg/g; g/g 48102-014_2af064d6-c0ee-45a9-8652-3869fffc5b74 48102-014 HUMAN PRESCRIPTION DRUG Neptazane methazolamide tablets TABLET ORAL 20100622 ANDA ANDA040062 Fera Pharmaceuticals METHAZOLAMIDE 25 mg/1 48102-015_2af064d6-c0ee-45a9-8652-3869fffc5b74 48102-015 HUMAN PRESCRIPTION DRUG Neptazane methazolamide tablets TABLET ORAL 20100622 ANDA ANDA040062 Fera Pharmaceuticals METHAZOLAMIDE 50 mg/1 48102-016_ef24c5f9-3a87-48bc-8e12-89f7fb47931c 48102-016 HUMAN PRESCRIPTION DRUG ILOTYCIN ERYTHROMYCIN OINTMENT OPHTHALMIC 20101012 ANDA ANDA062447 Fera Pharmaceuticals, LLC ERYTHROMYCIN .5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 48102-017_6a4a2053-f947-4ce3-a885-a1c1465c8b0b 48102-017 HUMAN OTC DRUG Puralube Mineral oil and white petrolatum OINTMENT OPHTHALMIC 20110202 OTC MONOGRAPH FINAL part349 Fera Pharmaceuticals MINERAL OIL; PETROLATUM 150; 850 mg/g; mg/g 48102-022_a5471dfb-05ab-4e26-acb0-c244d0f932a7 48102-022 HUMAN PRESCRIPTION DRUG GARAMYCIN GENTAMICIN SULFATE SOLUTION/ DROPS OPHTHALMIC 20110515 ANDA ANDA065121 Fera Pharmaceuticals, LLC GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 48102-100_2d620e91-b5ad-40a9-a93e-ee675e1fd5cf 48102-100 HUMAN PRESCRIPTION DRUG Methazolamide methazolamide TABLET ORAL 20100622 ANDA ANDA040062 Fera Pharmaceuticals METHAZOLAMIDE 25 mg/1 48102-101_2d620e91-b5ad-40a9-a93e-ee675e1fd5cf 48102-101 HUMAN PRESCRIPTION DRUG Methazolamide methazolamide TABLET ORAL 20100622 ANDA ANDA040062 Fera Pharmaceuticals METHAZOLAMIDE 50 mg/1 48102-102_405cd14c-1719-4942-986c-af184c1a30a5 48102-102 HUMAN PRESCRIPTION DRUG GENTAMICIN SULFATE GENTAMICIN SULFATE OINTMENT OPHTHALMIC 20110103 ANDA ANDA065024 Fera Pharmaceuticals, LLC GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 48102-103_7caa1fd5-debb-4de1-be58-a137e17bea0c 48102-103 HUMAN PRESCRIPTION DRUG SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM OINTMENT OPHTHALMIC 20120301 ANDA ANDA080029 Fera Pharmaceuticals, LLC SULFACETAMIDE SODIUM 100 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 48102-111_520bf183-6cae-47a5-a0d1-8a3847f46562 48102-111 HUMAN PRESCRIPTION DRUG Amoxicillin Extended-Release amoxicillin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140728 NDA AUTHORIZED GENERIC NDA050813 Fera Pharmaceuticals, LLC AMOXICILLIN 775 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 48256-0002_47237012-bb77-42b0-8deb-91b10690c2d9 48256-0002 HUMAN OTC DRUG WHITE FLOWER ANALGESIC BALM CAMPHOR, MENTHOL AND METHYL SALICYLATE OIL TOPICAL 20100611 OTC MONOGRAPH NOT FINAL part348 HOE HIN PAK FAH YEOW MANUFACTORY LTD CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 6; 14.5; 40.02 g/100mL; g/100mL; g/100mL 48256-0011_aed88b6f-3582-47a0-8997-0b14f52f9516 48256-0011 HUMAN OTC DRUG WHITE FLOWER ANALGESIC BALM FLORAL SCENTED CAMPHOR, MENTHOL AND METHYL SALICYLATE OIL TOPICAL 20100730 OTC MONOGRAPH NOT FINAL part348 HOE HIN PAK FAH YEOW MANUFACTORY LTD CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 5.4; 13; 35.8 g/100mL; g/100mL; g/100mL 48256-0041_167d01fa-8890-4ba1-b0d4-e779f1af4d98 48256-0041 HUMAN OTC DRUG WHITE FLOWER STRAIN RELIEF CAMPHOR, MENTHOL AND METHYL SALICYLATE OIL TOPICAL 20120307 OTC MONOGRAPH NOT FINAL part348 HOE HIN PAK FAH YEOW MANUFACTORY LTD CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 10.2; 15.3; 49.1 g/100mL; g/100mL; g/100mL 48273-001_3da11a68-b3e2-43fd-9e66-f724d102639d 48273-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19190101 UNAPPROVED MEDICAL GAS Keen Compressed Gas Co. Inc. OXYGEN 99 L/100L 48273-002_26bb98e6-98c1-49cf-9c91-a7d581ed39d0 48273-002 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19190101 UNAPPROVED MEDICAL GAS Keen Compressed Gas Co. Inc. NITROUS OXIDE 99 L/100L 48273-006_886211b1-c966-4313-95a2-cb7400d38e1d 48273-006 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19190101 UNAPPROVED MEDICAL GAS Keen Compressed Gas Co. Inc. NITROGEN 99 L/100L 48273-007_b97933d1-371f-499e-8ef4-9cf66d08e708 48273-007 HUMAN PRESCRIPTION DRUG MEDICAL AIR AIR GAS RESPIRATORY (INHALATION) 19190101 UNAPPROVED MEDICAL GAS Keen Compressed Gas Co. Inc. OXYGEN 21 L/100L 48324-773_8325368a-b0ee-4917-862a-afc488590ec6 48324-773 HUMAN OTC DRUG Sani Soft ALCOHOL AEROSOL, FOAM TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part333 Unlimited Sales, Inc. ALCOHOL 620 mg/g 48324-785_6b5c38e3-68fa-4926-b5c9-0f92758da48d 48324-785 HUMAN OTC DRUG Instant Hand Sanitizing Wipes BENZETHONIUM CHLORIDE CLOTH TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Unlimited Sales, Inc. BENZETHONIUM CHLORIDE 2 mg/g 48404-037_33361927-2f1d-43a1-b2bf-2332ae0baef7 48404-037 HUMAN OTC DRUG pre fense BENZALKONIUM CHLORIDE LIQUID TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333E Prefense LLC BENZALKONIUM CHLORIDE 28.39 mg/100mL 48404-106_0d37a812-ff1d-4bdc-a4d9-6830e534f72f 48404-106 HUMAN OTC DRUG Prefenz Silica Based Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Prefense LLC BENZALKONIUM CHLORIDE 12 mL/100mL 48407-0007_4fa0365f-d2a9-4d96-aa7e-2ce584e78169 48407-0007 HUMAN OTC DRUG TOKUHON-A External Analgesic Pain Relieving Medicated CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE PATCH TRANSDERMAL 20130404 OTC MONOGRAPH NOT FINAL part348 Tokuhon Corporation CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 3.27; 4.56; 10.12 mg/100mg; mg/100mg; mg/100mg 48407-0070_7ecc0c77-a181-475f-8538-f888411539f3 48407-0070 HUMAN OTC DRUG TOKUHON-A External Pain Relieving Medicated CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE PATCH TRANSDERMAL 20130826 OTC MONOGRAPH NOT FINAL part348 Tokuhon Corporation CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 3.27; 4.56; 10.12 mg/100mg; mg/100mg; mg/100mg 48417-712_0df2ebf3-5d76-427d-93d4-3ccb7a845c3a 48417-712 HUMAN OTC DRUG SaniSuds Foam Antibacterial Hand Triclosan SOAP TOPICAL 20091111 OTC MONOGRAPH NOT FINAL part333E Palmer Fixture Company TRICLOSAN 3 mg/mL 48417-726_90237e4b-4299-4b82-b481-0f9d1c185b88 48417-726 HUMAN OTC DRUG SaniSuds E-2 Foam Sanitizing Hand Benzalkonium Chloride SOAP TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part333E Palmer Fixture Company BENZALKONIUM CHLORIDE 1.3 mg/mL 48417-750_fe5d7193-3d51-4b9c-b34c-79f0c0238911 48417-750 HUMAN OTC DRUG SaniSuds Foam Hand Sanitizer Benzalkonium Chloride SOAP TOPICAL 20090407 OTC MONOGRAPH NOT FINAL part333E Palmer Fixture Company BENZALKONIUM CHLORIDE 1 mg/mL 48417-780_3c3b2b38-aee4-4894-8e28-507b5c132593 48417-780 HUMAN OTC DRUG SaniSuds Foam Instant Hand Sanitizer Alcohol SOAP TOPICAL 20091111 OTC MONOGRAPH NOT FINAL part333E Palmer Fixture Company ALCOHOL 650 mL/L 48433-100_e358437f-7c6b-4e49-957d-d7f5b8f4b8f5 48433-100 HUMAN PRESCRIPTION DRUG doxycycline hyclate doxycycline hyclate TABLET, FILM COATED ORAL 19860710 ANDA ANDA062677 Safecor Health, LLC DOXYCYCLINE HYCLATE 100 mg/1 48433-101_a2586a38-4e2c-4244-8618-0b614d585605 48433-101 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000501 OTC MONOGRAPH NOT FINAL part334 Safecor Health, LLC DOCUSATE SODIUM 250 mg/1 48433-106_636a00a9-9df5-40cb-940a-61cc52016a1b 48433-106 HUMAN OTC DRUG Calcium Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20140825 OTC MONOGRAPH FINAL part331 Safecor Health, LLC CALCIUM CARBONATE 500 mg/1 48433-107_3c2efeee-7e66-4b2b-8fc9-5e68f6076b0b 48433-107 HUMAN OTC DRUG Calcium Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20141001 OTC MONOGRAPH FINAL part331 Safecor Health, LLC CALCIUM CARBONATE 750 mg/1 48433-111_33c8c8f4-faaa-4bda-90c1-56e29c89b516 48433-111 HUMAN OTC DRUG Sore Throat Relief Cherry Flavor BENZOCAINE, MENTHOL LOZENGE ORAL 20140825 OTC MONOGRAPH NOT FINAL part356 Safecor Health, LLC BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 48433-200_1985f628-0cd7-4833-8933-40f07f7a2846 48433-200 HUMAN PRESCRIPTION DRUG Morphine Sulfate morphine sulfate SOLUTION ORAL 20130117 ANDA ANDA202348 Safecor Health, LLC MORPHINE SULFATE 20 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 48433-300_b921a0da-4642-4b8b-ac44-7e0d278722d0 48433-300 HUMAN PRESCRIPTION DRUG Calcium Acetate CALCIUM ACETATE TABLET ORAL 20140815 ANDA ANDA091561 Safecor Health, LLC CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 48433-301_45680e44-1ec1-48ed-81da-7b735ab09b47 48433-301 HUMAN OTC DRUG SENNA SENNOSIDES TABLET, COATED ORAL 20140930 OTC MONOGRAPH NOT FINAL part334 Safecor Health, LLC SENNOSIDES A AND B 8.6 mg/1 48433-302_640680ef-b856-467f-bbaf-1144b290d75d 48433-302 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20140930 OTC MONOGRAPH FINAL part331 Safecor Health, LLC MAGNESIUM OXIDE 400 mg/1 48433-303_97bf4e39-e53b-42fe-b770-03a0f568cff5 48433-303 HUMAN OTC DRUG aspirin low dose chewable aspirin TABLET, CHEWABLE ORAL 20140930 OTC MONOGRAPH NOT FINAL part343 Safecor Health, LLC ASPIRIN 81 mg/1 48433-304_9e0d04b2-bef8-4adf-aee4-c0fd2d62c84f 48433-304 HUMAN OTC DRUG Docusate Plus Senna DOCUSATE SODIUM-SENNOSIDES TABLET, FILM COATED ORAL 20140930 OTC MONOGRAPH NOT FINAL part334 Safecor Health, LLC DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; min/1 48433-305_5b102236-e994-4286-ba38-deb16b325228 48433-305 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, COATED ORAL 20140930 OTC MONOGRAPH NOT FINAL part343 Safecor Health, LLC ASPIRIN 325 mg/1 48433-306_0c27d406-45de-4df0-8db0-c3d654fe7637 48433-306 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140930 ANDA ANDA078787 Safecor Health, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 48433-307_0c27d406-45de-4df0-8db0-c3d654fe7637 48433-307 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140930 ANDA ANDA078787 Safecor Health, LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 48433-308_790129ef-6a1b-45cb-8b02-25fa8a40c2ba 48433-308 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20140930 ANDA ANDA078414 Safecor Health, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 48433-309_08c7d5d2-c2bf-4c60-baf2-f6ce9f4717d2 48433-309 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20140930 ANDA ANDA086242 Safecor Health, LLC HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 48433-310_4b7e66c1-154d-45d3-b98a-71882f49ae89 48433-310 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140930 ANDA ANDA202038 Safecor Health, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 48433-311_2a6a5f26-7d87-4a24-b51b-5613bbc3dbb7 48433-311 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20140930 ANDA ANDA077691 Safecor Health, LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 48433-312_12a9faa9-eb59-4b06-bbc0-7381f8526819 48433-312 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20140930 ANDA ANDA074141 Safecor Health, LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 48433-313_89a7ff72-3696-4f6b-aad5-e2600f761332 48433-313 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20140930 ANDA ANDA076670 Safecor Health, LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 48433-314_d7e7508a-6f54-4349-9bd4-238fa48b3ae3 48433-314 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20140930 NDA NDA018569 Safecor Health, LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 48433-315_2a297068-6155-40aa-bd2a-1a9ba1147785 48433-315 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20140930 ANDA ANDA075743 Safecor Health, LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 48433-316_b835dcf6-4cd0-4f68-a485-49182229c48a 48433-316 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20140930 ANDA ANDA077031 Safecor Health, LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 48433-317_09447713-fdab-4cb7-90a2-f769693dde6f 48433-317 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20140930 OTC MONOGRAPH NOT FINAL part334 Safecor Health, LLC DOCUSATE SODIUM 100 mg/1 48433-320_1fe298f3-05eb-496d-a49d-4c38ee772d5a 48433-320 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20140930 ANDA ANDA040756 Safecor Health, LLC FOLIC ACID 1 mg/1 48433-321_f7ee9ca2-5123-4230-9666-8eb07a6de8e4 48433-321 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140930 ANDA ANDA040362 Safecor Health, LLC PREDNISONE 20 mg/1 48433-322_b3ad652f-9d8e-4795-9cc4-981eb44d78f1 48433-322 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20140930 ANDA ANDA074726 Safecor Health, LLC POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 48433-323_b3ad652f-9d8e-4795-9cc4-981eb44d78f1 48433-323 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20140930 ANDA ANDA074726 Safecor Health, LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 48433-324_55c1bce9-9d05-4621-839d-a98b8d862692 48433-324 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20140930 ANDA ANDA091388 Safecor Health, LLC QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 48433-325_351a8502-fa66-4aea-ba79-cfa050332c51 48433-325 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20140930 ANDA ANDA077351 Safecor Health, LLC FAMOTIDINE 20 mg/1 48433-326_14f29eeb-4db9-47be-a981-1e9f400a2139 48433-326 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140930 ANDA ANDA075978 Safecor Health, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 48433-327_2f6e74e5-929c-4a74-a9e4-f56c2a7d575e 48433-327 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20140930 ANDA ANDA076048 Safecor Health, LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 48433-328_0c27d406-45de-4df0-8db0-c3d654fe7637 48433-328 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140930 ANDA ANDA078787 Safecor Health, LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 48433-329_cfcdaf7f-2aba-46ff-bbf1-e21a16aee4ed 48433-329 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140930 ANDA ANDA202957 Safecor Health, LLC HEPARIN SODIUM 5000 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 48433-330_cfcdaf7f-2aba-46ff-bbf1-e21a16aee4ed 48433-330 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140930 ANDA ANDA203198 Safecor Health, LLC HEPARIN SODIUM 10000 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 48433-347_5061ddfc-311f-44ff-adde-e71225e38be7 48433-347 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION, CONCENTRATE ORAL 20130923 NDA AUTHORIZED GENERIC NDA200535 Safecor Health, LLC OXYCODONE HYDROCHLORIDE 20 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 48546-0001_3e010eb3-6b6a-4150-ac8a-c8831fe2d695 48546-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Indiana Oxygen Company, Inc. OXYGEN 99 L/100L 48546-0002_3e010eb3-6b6a-4150-ac8a-c8831fe2d695 48546-0002 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19610101 UNAPPROVED MEDICAL GAS Indiana Oxygen Company, Inc. OXYGEN 99.5 L/100L 48599-345_4a180193-c181-4c86-bb96-9f75491cacb6 48599-345 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS NASAL 19650101 UNAPPROVED MEDICAL GAS Airweld, Inc. OXYGEN 99 L/100L 48663-0001_b139b672-645a-41ed-9ce6-0636f3c65abc 48663-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090415 UNAPPROVED MEDICAL GAS Michael R. Schroeder dba Respiratory Medical Services OXYGEN 99 L/100L 48664-001_09c29c76-3971-4f03-b3b5-cef201ad8e9c 48664-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen LIQUID RESPIRATORY (INHALATION) 19200101 UNAPPROVED MEDICAL GAS Weiler Welding Company OXYGEN 1.13835106 kg/L 48664-002_d5c5eb26-613e-4a99-9804-1c150e04b580 48664-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19200101 UNAPPROVED MEDICAL GAS Weiler Welding Company OXYGEN 992 L/1000L 48769-060_5490aefc-7dcf-4bc5-a359-bf34907a0486 48769-060 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130101 OTC MONOGRAPH FINAL part338 Softech Pharma Pvt. Ltd DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 48769-112_bf3c674d-cf65-438b-a38a-eca8362d399e 48769-112 HUMAN OTC DRUG SIMETHICONE Dimethicone CAPSULE, LIQUID FILLED ORAL 20120115 OTC MONOGRAPH FINAL part332 Softech Pharma Pvt. Ltd. DIMETHICONE 180 mg/1 48769-113_7871e699-2df2-4655-b2db-a2b721d145ac 48769-113 HUMAN OTC DRUG Simethicone Dimethicone CAPSULE, LIQUID FILLED ORAL 20120115 OTC MONOGRAPH FINAL part332 Softech Pharma Pvt. Ltd DIMETHICONE 125 mg/1 48783-112_890a54a9-c27b-495b-a278-c2091c42d7b3 48783-112 HUMAN PRESCRIPTION DRUG Monsels Solution Ferric Subsulfate PASTE TOPICAL 20140610 UNAPPROVED DRUG OTHER Premier Dental Products Company FERRIC SUBSULFATE 210 mg/g Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 48783-500_53f15ff7-8605-47c6-bb82-67d68efb015a 48783-500 HUMAN OTC DRUG Enamelon Preventive Treatment stannous fluoride GEL DENTAL 20140101 OTC MONOGRAPH FINAL part355 Premier Dental Products Company STANNOUS FLUORIDE .004 g/g 48783-520_8eaf074e-0c3f-49d5-9ac5-2578671a8e82 48783-520 HUMAN OTC DRUG Enamelon stannous fluoride PASTE, DENTIFRICE DENTAL 20140101 OTC MONOGRAPH FINAL part355 Premier Dental Products Company STANNOUS FLUORIDE .00454 g/g 48815-1001_9f74fdc8-f22c-45b2-ab88-dc8336d44d46 48815-1001 HUMAN PRESCRIPTION DRUG Sodium Iodide I 123 Sodium Iodide I 123 CAPSULE, GELATIN COATED ORAL 20030102 NDA NDA018671 Cardinal Health 418, Inc SODIUM IODIDE I-123 100 uCi/1 48815-1002_9f74fdc8-f22c-45b2-ab88-dc8336d44d46 48815-1002 HUMAN PRESCRIPTION DRUG Sodium Iodide I 123 Sodium Iodide I 123 CAPSULE, GELATIN COATED ORAL 20030102 NDA NDA018671 Cardinal Health 418, Inc SODIUM IODIDE I-123 200 uCi/1 48818-001_3783e7ed-7fb8-4b58-96e6-bc108cea99b2 48818-001 HUMAN PRESCRIPTION DRUG Folotyn pralatrexate INJECTION INTRAVENOUS 20090924 NDA NDA022468 Allos Therapeutics PRALATREXATE 20 mg/mL Folate Analog Metabolic Inhibitor [EPC] 48871-000_acecdf01-dc1a-4204-8bda-134abf496421 48871-000 HUMAN OTC DRUG CVS Pharmacy benzalkonium chloride, pramoxine hydrochloride SPRAY TOPICAL 20100119 OTC MONOGRAPH FINAL part310.545 Health-Tech, Inc. BENZALKONIUM CHLORIDE; PRAMOXINE HYDROCHLORIDE .195; .15 mL/15mL; mL/15mL 48871-001_6c68c1fd-6471-4c20-8ccc-e4e59cc1e3d2 48871-001 HUMAN OTC DRUG Harmon Face Values Hand Sanitizer Spray Alcohol SPRAY TOPICAL 20100331 OTC MONOGRAPH NOT FINAL part333 Health-Tech, Inc. ETHANOL 4.65 mL/7.5mL 48871-002_85ea2460-2a0d-4e0f-9430-c30dd74b9a43 48871-002 HUMAN OTC DRUG Hannaford Hand Sanitizer Ethyl alcohol SPRAY TOPICAL 20100331 OTC MONOGRAPH NOT FINAL part333 Health-Tech, Inc. ALCOHOL 4.65 mL/7.5mL 48871-003_84059b22-9f9a-493f-b952-1f09bfbd42e8 48871-003 HUMAN OTC DRUG Live Better hand sanitizer benzalkonium chloride SPRAY TOPICAL 20100331 OTC MONOGRAPH NOT FINAL part333 Health-Tech, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL 48871-005_874c9ac1-9470-4b13-8bcd-72e124fd5160 48871-005 HUMAN OTC DRUG Crayola Hand Sanitizing Foam benzalkonium chloride SPRAY TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Health-Tech, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL 48871-006_6f56256b-561e-438d-8eb3-35b7d14da253 48871-006 HUMAN OTC DRUG Crayola Wild Blue Yonder Roll On Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Health-Tech, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL 48871-007_576bf0fb-aa1b-4d91-ac42-9bf1b81816a7 48871-007 HUMAN OTC DRUG Crayola Radical Red Roll On Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Health-Tech, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL 48871-008_0ef7f255-aca0-4237-aa21-267780aca1d1 48871-008 HUMAN OTC DRUG Oral B Instant Pain Relief benzocaine GEL ORAL OTC MONOGRAPH NOT FINAL part333 Health-Tech, Inc. BENZOCAINE .2 mL/mL 48871-009_18387bfe-dc5b-490e-9a4d-ecc425ac74f4 48871-009 HUMAN OTC DRUG Crayola Sunglow Yellow Roll On Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Health-Tech, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL 48871-180_2296992d-070e-4329-955e-3fc9145f0a45 48871-180 HUMAN OTC DRUG Live Better Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Health Tech Inc POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 48878-0231_bfcdb6b4-85a4-485f-a2ce-3465e3a72953 48878-0231 HUMAN OTC DRUG Avagard D alcohol LOTION TOPICAL 19991001 OTC MONOGRAPH NOT FINAL part333E 3M ESPE Dental Products ALCOHOL 530.7 mg/mL 48878-0620_0e44c921-d3ab-427f-8d90-6506fdd12bf9 48878-0620 HUMAN PRESCRIPTION DRUG Peridex chlorhexidine gluconate RINSE ORAL 19860813 NDA NDA019028 3M ESPE Dental Products CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] 48878-3100_67711d90-6eef-4ca1-9c31-169b5ff15669 48878-3100 HUMAN PRESCRIPTION DRUG ControlRx sodium fluoride PASTE, DENTIFRICE ORAL 20050101 UNAPPROVED DRUG OTHER 3M ESPE Dental Products SODIUM FLUORIDE 11 mg/g 48878-3101_5e9d04d7-834d-4d9f-8cba-34a924accd04 48878-3101 HUMAN PRESCRIPTION DRUG ControlRx sodium fluoride PASTE, DENTIFRICE ORAL 20050101 UNAPPROVED DRUG OTHER 3M ESPE Dental Products SODIUM FLUORIDE 11 mg/g 48878-3110_845c37ca-808f-4119-b0f6-2a7e8b3228f8 48878-3110 HUMAN PRESCRIPTION DRUG ControlRx Multi sodium fluoride PASTE, DENTIFRICE ORAL 20070801 UNAPPROVED DRUG OTHER 3M ESPE Dental Products SODIUM FLUORIDE 11 mg/g 48878-3120_c136259c-ec90-4347-92a7-663430bd3014 48878-3120 HUMAN PRESCRIPTION DRUG Clinpro 5000 sodium fluoride PASTE, DENTIFRICE ORAL 20090101 UNAPPROVED DRUG OTHER 3M ESPE Dental Products SODIUM FLUORIDE 11 mg/g 48878-3130_58ed1965-4e68-4325-a4f1-1d8a9b3648b5 48878-3130 HUMAN PRESCRIPTION DRUG Clinpro 5000 sodium fluoride PASTE, DENTIFRICE ORAL 20101015 UNAPPROVED DRUG OTHER 3M ESPE Dental Products SODIUM FLUORIDE 11 mg/g 48878-3140_65840b21-2ea0-449a-84aa-39976c6d5dd0 48878-3140 HUMAN PRESCRIPTION DRUG Clinpro 5000 sodium fluoride PASTE, DENTIFRICE ORAL 20110107 UNAPPROVED DRUG OTHER 3M ESPE Dental Products SODIUM FLUORIDE 11 mg/g 48878-3150_c0a51486-5a0a-454c-b19b-dd11f273cedc 48878-3150 HUMAN OTC DRUG Clinpro Tooth Creme sodium fluoride PASTE, DENTIFRICE ORAL 20130718 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products SODIUM FLUORIDE 2.1 mg/g 48878-3160_0a04a9d3-c869-4a4a-b96f-4f56c91553e6 48878-3160 HUMAN PRESCRIPTION DRUG Fluoride Treatment sodium fluoride SOLUTION ORAL 20130517 UNAPPROVED DRUG OTHER 3M ESPE Dental Products SODIUM FLUORIDE 11 mg/g 48878-3214_97867ee1-2619-4df3-bdcc-735389152b69 48878-3214 HUMAN OTC DRUG OrthoWash sodium fluoride RINSE ORAL 20020401 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products SODIUM FLUORIDE .44 mg/mL 48878-3215_97867ee1-2619-4df3-bdcc-735389152b69 48878-3215 HUMAN OTC DRUG OrthoWash sodium fluoride RINSE ORAL 20020401 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products SODIUM FLUORIDE .44 mg/mL 48878-3223_59447e51-bb62-464c-a03d-e5094545dd92 48878-3223 HUMAN PRESCRIPTION DRUG CaviRinse sodium fluoride MOUTHWASH ORAL 20050101 UNAPPROVED DRUG OTHER 3M ESPE Dental Products SODIUM FLUORIDE 2 mg/mL 48878-3315_ea28002a-4e67-40f3-a1f9-322173fadd91 48878-3315 HUMAN OTC DRUG PerioMed stannous fluoride RINSE ORAL 19670701 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE 6.3 mg/g 48878-3316_ea28002a-4e67-40f3-a1f9-322173fadd91 48878-3316 HUMAN OTC DRUG PerioMed stannous fluoride RINSE ORAL 19670701 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE 6.3 mg/g 48878-3317_ea28002a-4e67-40f3-a1f9-322173fadd91 48878-3317 HUMAN OTC DRUG PerioMed stannous fluoride RINSE ORAL 19670701 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE 6.3 mg/g 48878-4020_88b8d315-c775-4d74-8645-624a62727235 48878-4020 HUMAN OTC DRUG Just For Kids stannous fluoride GEL ORAL 19970701 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE 4 mg/g 48878-4021_23b72290-e45f-4e83-9f4b-3e96967ad4cb 48878-4021 HUMAN OTC DRUG OMNI stannous fluoride GEL ORAL 19980201 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE 4 mg/g 48878-4031_23b72290-e45f-4e83-9f4b-3e96967ad4cb 48878-4031 HUMAN OTC DRUG OMNI stannous fluoride GEL ORAL 19980201 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE 4 mg/g 48878-4041_23b72290-e45f-4e83-9f4b-3e96967ad4cb 48878-4041 HUMAN OTC DRUG OMNI stannous fluoride GEL ORAL 19980201 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE 4 mg/g 48878-4051_23b72290-e45f-4e83-9f4b-3e96967ad4cb 48878-4051 HUMAN OTC DRUG OMNI stannous fluoride GEL ORAL 19980201 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE 4 mg/g 48878-4061_23b72290-e45f-4e83-9f4b-3e96967ad4cb 48878-4061 HUMAN OTC DRUG OMNI stannous fluoride GEL ORAL 19980201 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE 4 mg/g 48878-4070_88b8d315-c775-4d74-8645-624a62727235 48878-4070 HUMAN OTC DRUG Just For Kids stannous fluoride GEL ORAL 19970701 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE 4 mg/g 48878-4080_88b8d315-c775-4d74-8645-624a62727235 48878-4080 HUMAN OTC DRUG Just For Kids stannous fluoride GEL ORAL 19970701 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE 4 mg/g 48883-001_7b3aa405-9e0a-4a6c-8b72-7368986b442b 48883-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19550101 UNAPPROVED MEDICAL GAS Encompass Medical & Specialty Gases, Ltd. OXYGEN 990 mL/L 48883-002_94a87283-d126-49c2-9542-135492092215 48883-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19550101 UNAPPROVED MEDICAL GAS Encompass Medical & Specialty Gases, Ltd. NITROGEN 990 mL/L 48883-003_fcf00538-62b2-43fe-b00f-a70b7a73c18a 48883-003 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20080102 UNAPPROVED MEDICAL GAS Encompass Medical & Specialty Gases, Ltd. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 48883-004_ef3b5bcc-51d6-4ec8-8f5d-d5b8ff7fbba5 48883-004 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RECTAL 20080102 UNAPPROVED MEDICAL GAS Encompass Medical & Specialty Gases, Ltd. NITROUS OXIDE 990 mL/L 48883-005_2080f772-ea23-4d7e-89e3-c3083b49a61f 48883-005 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20070401 UNAPPROVED MEDICAL GAS Encompass Medical & Specialty Gases, Ltd. AIR 1000 mL/L 48883-006_6c805a0d-190e-4913-8773-189291f0161d 48883-006 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 20090415 UNAPPROVED MEDICAL GAS Encompass Medical & Specialty Gases, Ltd. HELIUM 990 mL/L 48883-007_7f1be800-2f65-44ac-b6fa-df6904a1b0ec 48883-007 HUMAN PRESCRIPTION DRUG Helium Oxygen Mix Helium Oxygen Mix GAS RESPIRATORY (INHALATION) 20090415 UNAPPROVED MEDICAL GAS Encompass Medical & Specialty Gases Ltd HELIUM; OXYGEN 500; 500 mL/L; mL/L 48948-406_81635a6a-41fc-43eb-8ace-b5a873635dcb 48948-406 HUMAN PRESCRIPTION DRUG Pre-Tabs DHA Prenatal Multi-vitamin/Mineral Supplement with DHA/EPA Sodium Ascorbate, Cholecalciferol, di-alpha-Tocopheryl Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine HCL, Folic Acid, Cyanocobalamin, Calcium Formate, Calcium Carbonate, Ferrous (II) bis-Glycinate Chelate, Potassium Iodide, Zinc Oxide, Choline Bitartrate, with Doconexent and Icosapent KIT 20140615 UNAPPROVED DRUG OTHER DEREMETRX LLC 48951-0076_8e61c411-3a36-44bc-974d-4570a5dd5519 48951-0076 HUMAN OTC DRUG Apis Levisticum Ear Irritation Relief APIS MELLIFERA, LEVISTICUM OFFICINALE LEAF PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc APIS MELLIFERA; LEVISTICUM OFFICINALE LEAF 3; 3 [hp_X]/1; [hp_X]/1 48951-0077_b6c88249-0598-44f0-9a41-e1e27faba7c2 48951-0077 HUMAN OTC DRUG Arnica Echinacea First Aid BELLIS PERENNIS, ECHINACEA UNSPECIFIED, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ST. JOHNS WORT, ACHILLEA MILLEFOLIUM, ACONITUM NAPELLUS, ARNICA MONTANA, ATROPA BELLADONNA, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, CALCIUM SULFIDE, MERCURIUS SOLUBILIS, COMFREY ROOT PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; ST. JOHN'S WORT 6; 6; 6; 6; 5; 9; 6; 9; 5; 5; 6; 9; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-0078_014a6668-9f50-468d-9d42-6bcab88d1a0b 48951-0078 HUMAN OTC DRUG Avena Valeriana Nerve Relief AVENA SATIVA FLOWERING TOP, VALERIAN, OSTREA EDULIS SHELL, PHOSPHORUS, SULFUR PELLET ORAL 20091201 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc AVENA SATIVA FLOWERING TOP; OSTREA EDULIS SHELL; PHOSPHORUS; SULFUR; VALERIAN 3; 7; 30; 30; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1001_dc9598d3-c45f-4b37-b607-1a3da266ee48 48951-1001 HUMAN OTC DRUG Viscum Abietis VISCUM ALBUM FRUITING TOP LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL 48951-1002_2e041734-073f-4282-978b-6edf77431f30 48951-1002 HUMAN OTC DRUG Viscum Crataegi VISCUM ALBUM FRUITING TOP LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL 48951-1003_5312d43d-ea13-435f-aeb0-65c166239a9e 48951-1003 HUMAN OTC DRUG Viscum Mali VISCUM ALBUM FRUITING TOP LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL 48951-1004_1e8b0c55-86c7-494b-b054-0fd14c369c76 48951-1004 HUMAN OTC DRUG Viscum Pini VISCUM ALBUM FRUITING TOP LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL 48951-1005_7c6daab0-6b07-4cb1-ba55-d3ef021da00c 48951-1005 HUMAN OTC DRUG Viscum Populi VISCUM ALBUM FRUITING TOP LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL 48951-1006_fe0e2f22-a395-433e-8ccb-db619c993ff9 48951-1006 HUMAN OTC DRUG Viscum Quercus VISCUM ALBUM FRUITING TOP LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL 48951-1007_2ccc0327-1a79-4199-952b-4a2ed6c976dd 48951-1007 HUMAN OTC DRUG Viscum Salicis VISCUM ALBUM FRUITING TOP LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL 48951-1008_4faee4e6-3b60-473f-8ffa-b3f2f70b8645 48951-1008 HUMAN OTC DRUG Viscum Tiliae VISCUM ALBUM FRUITING TOP LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL 48951-1009_5a791665-f95c-4ccb-8e82-392e65cb93b3 48951-1009 HUMAN OTC DRUG Aconitum e tub. 6 Aconitum e tub. 6 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS 6 [hp_X]/1 48951-1010_f20c4fed-6c80-4a83-bee1-5a7c5fd4ca35 48951-1010 HUMAN OTC DRUG Adonis Crataegus Special Order Adonis Crataegus Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ADONIS VERNALIS FLOWERING TOP; HAWTHORN LEAF WITH FLOWER; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 3; 3; 4; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1011_b99b7143-af1a-42eb-8c9d-3beca94c4677 48951-1011 HUMAN OTC DRUG Adonis Crataegus Adonis Crataegus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ADONIS VERNALIS FLOWERING TOP; HAWTHORN LEAF WITH FLOWER; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 3; 3; 4; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1013_14ccdf7e-fd8e-4ad0-bb0a-2e27ecd0614b 48951-1013 HUMAN OTC DRUG Aesculus e cort. 3 Aesculus e cort. 3 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AESCULUS HIPPOCASTANUM BARK 3 [hp_X]/1 48951-1014_c80bc089-5567-45b2-8e90-3da7316d3641 48951-1014 HUMAN OTC DRUG Aesculus e cort. 32 Special Order Aesculus e cort. 32 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AESCULUS HIPPOCASTANUM BARK 32 [hp_X]/mL 48951-1016_c120a998-0b8f-407b-8197-65b2e99ee5d9 48951-1016 HUMAN OTC DRUG Aesculus Quercus Essence Aesculus Quercus Essence LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BORAGO OFFICINALIS WHOLE; HORSE CHESTNUT; MELILOTUS INDICUS SEED; QUERCUS ROBUR WHOLE; SLOE; SOLIDAGO VIRGAUREA FLOWERING TOP 1; 1; 1; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1019_e9c3fad7-7a6c-4d5f-baa0-8d838f549e23 48951-1019 HUMAN OTC DRUG Agaricus e pl. tota 4 Special Order Agaricus e pl. tota 4 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMANITA MUSCARIA FRUITING BODY 4 [hp_X]/mL 48951-1021_238d580e-3648-427c-8684-d0400761aedb 48951-1021 HUMAN OTC DRUG Apis Rhus Apis Rhus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BRYONIA ALBA ROOT; TOXICODENDRON PUBESCENS LEAF 2; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1022_bd6ce0b1-0fa9-4e95-9ec8-423a7f60f2cd 48951-1022 HUMAN OTC DRUG Agaricus Phosphorus Agaricus Phosphorus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMANITA MUSCARIA FRUITING BODY; DRYOPTERIS FILIX-MAS ROOT; OSTREA EDULIS SHELL; PHOSPHORUS; SILVER FLUORIDE 8; 3; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1023_a75bae9c-e9ff-4fc5-8f65-a61582ec77d5 48951-1023 HUMAN OTC DRUG Agaricus Phosphorus Agaricus Phosphorus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMANITA MUSCARIA FRUITING BODY; DRYOPTERIS FILIX-MAS ROOT; OSTREA EDULIS SHELL; PHOSPHORUS; SILVER FLUORIDE 8; 3; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1024_ce684edc-9826-49af-8ce6-3a22d4fc9a80 48951-1024 HUMAN OTC DRUG Agnus castus e sem. 4 Agnus castus e sem. 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACMELLA OLERACEA WHOLE; ANGELICA ARCHANGELICA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CUPRIC ACETATE; ECHINACEA, UNSPECIFIED; INULA HELENIUM ROOT; LEVISTICUM OFFICINALE ROOT; PLANTAGO MAJOR LEAF; VERBASCUM DENSIFLORUM LEAF 2; 1; 3; 3; 1; 6; 2; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1025_c4d14b96-ef46-4af4-8183-d8f3c56f6acb 48951-1025 HUMAN OTC DRUG Amber Amethyst Teething Relief Amber Amethyst Teething Relief CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMBER; COLLOIDAL SILICON DIOXIDE; EQUISETUM ARVENSE TOP; HORSE CHESTNUT 3; 6; 2; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-1026_9f1c430f-a8d0-4c37-bad6-d9cc2b70fbf3 48951-1026 HUMAN OTC DRUG Amethyst Rosa Clear Skin Amethyst Rosa Clear Skin CAPSULE ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACORUS CALAMUS ROOT; ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; BETULA PUBESCENS LEAF; BLACK PEPPER; COCHLEARIA OFFICINALIS FLOWERING TOP; FERRIC OXIDE RED; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GEUM URBANUM ROOT; GINGER; GRAPHITE; MATRICARIA RECUTITA; OXALIS MONTANA LEAF; ROSA RUGOSA FLOWER BUD; SILICON DIOXIDE; URTICA DIOICA LEAF; URTICA DIOICA ROOT; WORMWOOD 4; 2; 5; 4; 5; 4; 6; 3; 4; 4; 4; 17; 4; 4; 4; 2; 4; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1027_7d587c33-4a4e-42ec-bbcf-9b4f28fc6a2f 48951-1027 HUMAN OTC DRUG Ammi Nicotiana Adult Size Ammi Nicotiana Adult Size SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMMI VISNAGA FRUIT; ATROPA BELLADONNA; MATRICARIA RECUTITA; TOBACCO LEAF 1; 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-1028_838c2433-7864-4d70-bbc3-a980b420fd80 48951-1028 HUMAN OTC DRUG Amnion 30 Amnion 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMNIOTIC FLUID (BOVINE) 30 [hp_X]/mL 48951-1030_a7a61a6c-b1aa-4bda-b4c9-c713ada8022a 48951-1030 HUMAN OTC DRUG Anagallis Taraxacum Anagallis Taraxacum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANAGALLIS ARVENSIS; CICHORIUM INTYBUS WHOLE; FRAGARIA VESCA WHOLE; MILK THISTLE; POTASSIUM CARBONATE; TARAXACUM PALUSTRE ROOT; VITIS VINIFERA LEAF 5; 7; 5; 5; 7; 5; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1031_4b289625-05d4-4469-be3d-be3b8516930b 48951-1031 HUMAN OTC DRUG Anagallis Taraxacum Aanagallis Taraxacum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANAGALLIS ARVENSIS; CICHORIUM INTYBUS WHOLE; FRAGARIA VESCA WHOLE; MILK THISTLE; POTASSIUM CARBONATE; TARAXACUM PALUSTRE ROOT; VITIS VINIFERA LEAF 3; 6; 5; 3; 6; 3; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1032_5a38f8f5-eb7d-4ab6-ae4c-9848ef868898 48951-1032 HUMAN OTC DRUG Ananassa Resina Ananassa Resina LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; LARIX DECIDUA RESIN; PINEAPPLE 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1033_bc354141-166d-4dc9-b776-5c98d34d7057 48951-1033 HUMAN OTC DRUG Ananassa Resina Ananassa Resina CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; LARIX DECIDUA RESIN; PINEAPPLE 6; 2; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-1034_7c9be59e-afb2-472f-876f-b9c9e80480a0 48951-1034 HUMAN OTC DRUG Ananassa Resina Ananassa Resina PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; LARIX DECIDUA RESIN; PINEAPPLE 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1035_8fc13442-d7db-4e35-b7dd-c139c10a444e 48951-1035 HUMAN OTC DRUG Angelica Comp. Angelica Comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACMELLA OLERACEA WHOLE; ANGELICA ARCHANGELICA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CUPRIC ACETATE; ECHINACEA ANGUSTIFOLIA; INULA HELENIUM ROOT; LEVISTICUM OFFICINALE ROOT; PLANTAGO MAJOR LEAF; VERBASCUM DENSIFLORUM LEAF 2; 1; 3; 3; 1; 6; 2; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1037_2fa6e005-f97d-4cc2-bb55-2f94c9f824e8 48951-1037 HUMAN OTC DRUG Antimonite Belladonna Antimonite Belladonna POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY TRISULFIDE; ATROPA BELLADONNA; BISMUTH SUBNITRATE; MATRICARIA RECUTITA 3; 4; 6; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-1039_12973323-89bc-41d3-ab23-9335f913fd7e 48951-1039 HUMAN OTC DRUG Aorta 6 Special Order Aorta 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ARTERY 6 [hp_X]/mL 48951-1040_7524b8a6-d668-4f7d-9e4d-627dbff58cf6 48951-1040 HUMAN OTC DRUG Aorta Belladonna Aorta Belladonna PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; BOS TAURUS ARTERY 5; 5 [hp_X]/1; [hp_X]/1 48951-1041_55be5f1c-75e5-4a80-992c-e72d480abf1f 48951-1041 HUMAN OTC DRUG Apatite Cucurbita Apatite Cucurbita POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUCURBITA PEPO FLOWER; FLUORAPATITE 3; 6 g/g; g/g 48951-1042_605cac09-3f4f-43c2-ada3-8a0c7bc7259f 48951-1042 HUMAN OTC DRUG Apis Aconitum Apis Aconitum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ATROPA BELLADONNA 12; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1043_75c8af50-ac39-4941-9bb6-649d63d76ef6 48951-1043 HUMAN OTC DRUG Apis Arnica Apis Arnica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ARNICA MONTANA 3; 3 [hp_X]/mL; [hp_X]/mL 48951-1044_6f01f94d-680d-4ca5-9202-576f287d60e6 48951-1044 HUMAN OTC DRUG Apis Arnica Apis Arnica PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ARNICA MONTANA 3; 3 [hp_X]/1; [hp_X]/1 48951-1045_2e1395da-2961-448f-8732-92a42577f91b 48951-1045 HUMAN OTC DRUG Apis Belladonna Apis Belladonna LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA 5; 4 [hp_X]/mL; [hp_X]/mL 48951-1046_bfbea686-4776-4e3e-841d-ec3a7fd4ebba 48951-1046 HUMAN OTC DRUG Apis Belladonna Apis Belladonna CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; POTASSIUM CHLORIDE 6; 6; 7; 7; 2; 9; 16; 16; 5 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-1047_176bb710-b4aa-4a2b-a7c3-ec342935ade3 48951-1047 HUMAN OTC DRUG Apis Belladonna Fever Relief ATROPA BELLADONNA, APIS MELLIFERA PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc APIS MELLIFERA; ATROPA BELLADONNA 5; 4 [hp_X]/1; [hp_X]/1 48951-1048_dbab3a74-0b7d-4232-9491-f37ad2826d83 48951-1048 HUMAN OTC DRUG AURUM PLUMBUM AURUM PLUMBUM PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; GOLD; HONEY; LEAD 10; 10; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1049_2751bd64-5bf1-427a-bd24-3828b93c91f2 48951-1049 HUMAN OTC DRUG Apis Belladonna Mercurius Apis Belladonna Mercurius PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA; MERCURIUS SOLUBILIS 5; 4; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1050_bf7f2d0a-791b-4074-bcde-9681f3387fa1 48951-1050 HUMAN OTC DRUG Apis Bryonia Apis Bryonia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BRYONIA ALBA ROOT 3; 3 [hp_X]/mL; [hp_X]/mL 48951-1051_0410e949-5747-4bdd-b34c-f9bce82cb17d 48951-1051 HUMAN OTC DRUG Apis Bryonia Special Order Apis Bryonia Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BRYONIA ALBA ROOT 3; 3 [hp_X]/1; [hp_X]/1 48951-1052_9c0596f7-690f-4e54-8db7-bbcc0292f90b 48951-1052 HUMAN OTC DRUG Apis Eucalyptus Special Order Apis Eucalyptus Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA; EUCALYPTUS GUM 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-1053_8c877615-fdce-4ea0-8fca-e2ff11dd13ad 48951-1053 HUMAN OTC DRUG Apis ex animale 30 Apis ex animale 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA 30 [hp_X]/mL 48951-1054_f955c702-5567-41cf-a0b7-9003dde78b42 48951-1054 HUMAN OTC DRUG Apis ex animale 30 Special Order Apis ex animale 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA 30 [hp_X]/mL 48951-1055_44eeb289-9298-426c-bfab-f1a18911ac51 48951-1055 HUMAN OTC DRUG Apis ex animale 4 Special Order Apis ex animale 4 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA 4 [hp_X]/mL 48951-1056_a279227d-494c-41b8-8e09-8f25cde63786 48951-1056 HUMAN OTC DRUG Apis ex animale 6 Special Order Apis ex animale 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA 6 [hp_X]/mL 48951-1057_cd1188d0-4494-4a04-927d-dd3df23fe8ef 48951-1057 HUMAN OTC DRUG Apis Gelsemium Apis Gelsemium LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ARNICA MONTANA ROOT; BERBERIS VULGARIS ROOT BARK; COLCHICUM AUTUMNALE FLOWER; FORMICA RUFA; GELSEMIUM SEMPERVIRENS ROOT; PSEUDOGNAPHALIUM LUTEOALBUM LEAF 4; 10; 3; 5; 5; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1058_8eceb9f9-6f5b-4297-8584-589f0a544805 48951-1058 HUMAN OTC DRUG Apis Levisticum Apis Levisticum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; LEVISTICUM OFFICINALE ROOT 3; 3 [hp_X]/mL; [hp_X]/mL 48951-1060_e167e8bd-4719-4057-bec2-b59074b89062 48951-1060 HUMAN OTC DRUG Apis Phosphorus Apis Phosphorus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; PHOSPHORUS; SILVER SULFIDE 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1061_234bbf8c-efae-42bf-8d4c-a5dbd947d0ef 48951-1061 HUMAN OTC DRUG Apis Regina Cerebri Apis Regina Cerebri LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ASTRAGALUS PROPINQUUS ROOT; BOS TAURUS BRAINSTEM; ROYAL JELLY 20; 8; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1062_6f7ed724-1a1a-4158-9bf7-f17ba9a65d22 48951-1062 HUMAN OTC DRUG Apis regina Cerebri Apis regina Cerebri PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA ROOT; BOS TAURUS BRAINSTEM; ROYAL JELLY 20; 8; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1063_91796e59-171f-4b6d-9618-f1397c9f160e 48951-1063 HUMAN OTC DRUG Agaricus e pl. tota 6 Special Order Agaricus e pl. tota 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMANITA MUSCARIA FRUITING BODY 6 [hp_X]/mL 48951-1064_56858664-189c-4677-9b61-23fe32b93e56 48951-1064 HUMAN OTC DRUG Apis venenum purum 5 Apis venenum purum 5 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA VENOM 5 [hp_X]/mL 48951-1065_511880a0-ead0-408b-87b5-9108b20b6173 48951-1065 HUMAN OTC DRUG Aquavit 1 Aquavit 1 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMBERGRIS; ANGELICA ARCHANGELICA ROOT; ANISE; BLACK PEPPER; CALENDULA OFFICINALIS FLOWERING TOP; CARAWAY SEED; CARDAMOM; CENTAURIUM ERYTHRAEA FLOWERING TOP; CHAMOMILE; CINNAMON; COLA NUT; CORIANDER OIL; EQUISETUM ARVENSE TOP; FENNEL SEED; FERRIC OXIDE RED; FERROUS ARSENATE; FUMARIA OFFICINALIS FLOWERING TOP; GINGER; GOLD; HONEY; HYSSOPUS OFFICINALIS WHOLE; IMPERATORIA OSTRUTHIA ROOT; JUNIPER BERRY; LAVANDULA ANGUSTIFOLIA FLOWER; LESSER GALANGAL ROOT; LITSEA CUBEBA FRUIT; LONG PEPPER; MYRISTICA FRAGRANS WHOLE; OREGANO; PRUNUS SPINOSA FLOWER BUD; QUILLAJA SAPONARIA BARK; ROSA RUGOSA FLOWER; ROSMARINUS OFFICINALIS FLOWERING TOP; SAFFRON; ST. JOHN'S WORT; SWEET MARJORAM; SYZYGIUM AROMATICUM FRUIT; TANGERINE; THYME; VANILLA 10; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 11; 8; 4; 4; 12; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 11; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1066_8dc72124-adfd-4d1a-a2f8-274f00d8bc7e 48951-1066 HUMAN OTC DRUG Aquavit Etheric Energizer ANISE ANGELICA ARCHANGELICA ROOT BLACK PEPPER PRUNUS SPINOSA BUDDING TOP CALENDULA OFFICINALIS FLOWERING TOP CARAWAY SEED MATRICARIA RECUTITA GINGER EQUISETUM ARVENSE TOP JUNIPERUS COMMUNIS FRUIT ORIG LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ANGELICA ARCHANGELICA ROOT; ANISE; BLACK PEPPER; CALENDULA OFFICINALIS FLOWERING TOP; CARAWAY SEED; CINCHONA OFFICINALIS BARK; EQUISETUM ARVENSE TOP; GINGER; GOLD; HYPERICUM PERFORATUM; JUNIPERUS COMMUNIS FRUIT; MATRICARIA RECUTITA; MELISSA OFFICINALIS; ORIGANUM MAJORANA; PRUNUS SPINOSA BUDDING TOP; ROSE PETAL EXTRACT; ROSEMARY; SAGE 1; 1; 1; 1; 1; 2; 1; 1; 3; 3; 1; 1; 1; 1; 1; 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1067_79a0d33f-8549-4d82-87de-ffee559e7558 48951-1067 HUMAN OTC DRUG Aquilinum Taraxicum Aquilinum Taraxicum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ASPLENIUM SCOLOPENDRIUM TOP; CHELIDONIUM MAJUS; DRYOPTERIS FILIX-MAS ROOT; PTERIDIUM AQUILINUM WHOLE; SALIX PURPUREA BARK; SOLIDAGO CANADENSIS FLOWERING TOP; TARAXACUM PALUSTRE ROOT 5; 5; 5; 5; 5; 5; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1068_27a4bc72-2345-4e9e-be06-13c776937659 48951-1068 HUMAN OTC DRUG Aquilinum Taraxacum Aquilinum Taraxacum CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ASPLENIUM SCOLOPENDRIUM TOP; CHELIDONIUM MAJUS; DRYOPTERIS FILIX-MAS ROOT; PTERIDIUM AQUILINUM WHOLE; SALIX PURPUREA BARK; SOLIDAGO CANADENSIS FLOWERING TOP; TARAXACUM PALUSTRE ROOT; WILLOW BARK 3; 3; 3; 3; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-1069_c3ddaede-e7f0-45d3-a774-f7140d02d808 48951-1069 HUMAN OTC DRUG Aquilinum Taraxacum Aquilinum Taraxacum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ASPLENIUM SCOLOPENDRIUM TOP; CHELIDONIUM MAJUS; DRYOPTERIS FILIX-MAS ROOT; PTERIDIUM AQUILINUM WHOLE; SALIX ALBA FLOWER; SALIX PURPUREA BARK; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM PALUSTRE ROOT; WILLOW BARK 5; 5; 5; 5; 5; 5; 5; 5; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1070_150260d7-d4ab-46d5-8a1f-a71a5184954d 48951-1070 HUMAN OTC DRUG Aquilinum Taraxicum Aquilinum Taraxicum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ASPLENIUM SCOLOPENDRIUM TOP; CHELIDONIUM MAJUS; DRYOPTERIS FILIX-MAS ROOT; PTERIDIUM AQUILINUM WHOLE; SALIX ALBA FLOWER; SALIX PURPUREA BARK; SOLIDAGO CANADENSIS FLOWERING TOP; TARAXACUM PALUSTRE ROOT; WILLOW BARK 3; 3; 3; 3; 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1072_ea984552-6f0f-4a0e-a6ee-5a8a177846ff 48951-1072 HUMAN OTC DRUG Archangelica Eucalyptus Archangelica Eucalyptus OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANGELICA ARCHANGELICA ROOT; EUCALYPTUS OIL 1; 1 [hp_X]/100g; [hp_X]/100g 48951-1073_76986f2d-328c-4138-a21a-c1a0147a1880 48951-1073 HUMAN OTC DRUG Argentite Urtica Argentite Urtica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PITUITARY GLAND; BOS TAURUS TESTICLE; ROYAL JELLY; SAW PALMETTO; SILVER SULFIDE; URTICA DIOICA 6; 6; 6; 4; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1074_e0b01a9f-bda0-42fb-86b7-e45f60392a1a 48951-1074 HUMAN OTC DRUG Argentum 0.4 Argentum 0.4 OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 1 [hp_X]/g 48951-1075_79bb993c-9c92-4081-9a34-e23afb48a744 48951-1075 HUMAN OTC DRUG Argentum 0.4% Adult Argentum 0.4% Adult SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 2 [hp_X]/g 48951-1076_991c9968-6ea3-42e7-9283-43ff48defc2a 48951-1076 HUMAN OTC DRUG Argentum 10/20/30 Special Order Argentum 10/20/30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 10 [hp_X]/mL 48951-1077_6c6c2c71-7709-460c-8067-8b2750dcface 48951-1077 HUMAN OTC DRUG Argentum 10 Special Order Argentum 10 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 10 [hp_X]/mL 48951-1079_fba47e7d-49b1-468a-aba8-6ce5ff6e2821 48951-1079 HUMAN OTC DRUG Argentum 17 Special Order Argentum 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 17 [hp_X]/mL 48951-1082_a79ee188-f116-4df6-b98e-7f1165fcab6b 48951-1082 HUMAN OTC DRUG Argentum 30 Special Order Argentum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 30 [hp_X]/mL 48951-1084_19d8bc7b-c7a6-409d-b7b2-9bc7363f9cb5 48951-1084 HUMAN OTC DRUG Argentum 5 Argentum 5 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 5 [hp_X]/g 48951-1085_8b2cf79f-cfe5-4e22-919d-04c7e8788f1d 48951-1085 HUMAN OTC DRUG Argentum 6 Argentum 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 6 [hp_X]/mL 48951-1087_3b391832-52cf-488c-8ccc-e8a06183fc49 48951-1087 HUMAN OTC DRUG Argentum 8 Argentum 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 8 [hp_X]/mL 48951-1088_91324365-d156-40d6-ac51-cb2c3884762d 48951-1088 HUMAN OTC DRUG Argentum Bryophyllum Argentum Bryophyllum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; SILVER 6; 10 [hp_X]/mL; [hp_X]/mL 48951-1090_3994cbae-87b0-42ab-a0d8-42d5bca0c9e5 48951-1090 HUMAN OTC DRUG Argentum Bryophyllum Argentum Bryophyllum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; SILVER 6; 10 [hp_X]/1; [hp_X]/1 48951-1092_66afa158-616f-4842-829f-a7b92989da4e 48951-1092 HUMAN OTC DRUG Argentum Malachite Athletes Foot Relief Argentum Malachite Athletes Foot Relief CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AZADIRACHTA INDICA FLOWER; CUPRIC CATION; MERCURY; SILVER 2; 3; 6; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-1094_74a1dc63-49e5-4530-857e-8417ec99e554 48951-1094 HUMAN OTC DRUG Argentum nitricum 20 Special Order Argentum nitricum 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 20 [hp_X]/mL 48951-1096_fec5033a-b9f4-4b5a-ae05-a104ddfb2b7a 48951-1096 HUMAN OTC DRUG Argentum Nitricum Argentum Nitricum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 4 [hp_X]/mL 48951-1097_947c6a37-6064-4d7c-93b2-c2f1f330b9cc 48951-1097 HUMAN OTC DRUG Argentum Quartz Argentum Quartz PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; SILVER 30; 20 [hp_X]/1; [hp_X]/1 48951-1098_d3060de7-ce19-4b3d-b7fe-97d33eb7a3e9 48951-1098 HUMAN OTC DRUG Argentum Quartz Argentum Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; SILVER 30; 20 [hp_X]/mL; [hp_X]/mL 48951-1099_fac72ca6-d6b3-469e-8b57-070f07f8a673 48951-1099 HUMAN OTC DRUG Argentum Saccharum Special Order Argentum Saccharum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OXALIS MONTANA LEAF; SILVER; SUGARCANE 6; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1100_fbfd4ea4-fb6a-4ef7-a0b7-b5b2368360ac 48951-1100 HUMAN OTC DRUG Argentum Saccharum Special Order Argentum Saccharum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OXALIS MONTANA LEAF; SILVER; SUGARCANE 6; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1101_4ac6c94a-3a8a-4415-a361-839b80f7f106 48951-1101 HUMAN OTC DRUG Argentum Veratrum Argentum Veratrum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BOS TAURUS PARATHYROID GLAND; CUPRIC SULFATE; GOLD; MAGNESIUM SULFATE; PHOSPHORUS; SILVER; SUGARCANE; SUS SCROFA PANCREAS; TARAXACUM PALUSTRE ROOT; URTICA DIOICA; VERATRUM ALBUM ROOT 5; 7; 4; 9; 4; 6; 6; 5; 5; 2; 2; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1102_3fbac62d-52e7-4385-889c-3789a00dfa9f 48951-1102 HUMAN OTC DRUG Argentum Viscum Argentum Viscum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS EYE; SILVER CHLORIDE; VISCUM ALBUM FRUITING TOP 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1103_2f973e28-413c-4bdb-83ef-461506bf9e7e 48951-1103 HUMAN OTC DRUG Arnica Aconitum Arnica Aconitum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ARNICA MONTANA FLOWER; BETULA PUBESCENS LEAF; MANDRAGORA OFFICINARUM ROOT 4; 1; 2; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1106_e59172c3-e4fc-4e04-a489-4428e1799550 48951-1106 HUMAN OTC DRUG Arnica Aurum 20/30 Arnica Aurum 20/30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 20; 30; 4; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1107_f9665546-b6f8-4678-a19f-07e313ba6a3e 48951-1107 HUMAN OTC DRUG Arnica Aurum 20/30 Arnica Aurum 20/30 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 20; 30; 4; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1108_06d2bded-d902-44e9-aa85-c0acb81af6d1 48951-1108 HUMAN OTC DRUG Arnica Aurum 6 10 Arnica Aurum 6 10 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 6; 10; 4; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1109_206f462c-0eda-4cb4-a1f5-388bf7659e3c 48951-1109 HUMAN OTC DRUG Arnica Aurum 6/10 Arnica Aurum 6/10 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 6; 10; 4; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1111_c9311345-c95a-4440-8d0b-4ee4f18751f3 48951-1111 HUMAN OTC DRUG Arnica Aurum Equisetum Arnica Aurum Equisetum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; EQUISETUM ARVENSE TOP; GOLD 3; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1112_497e0caf-f91a-4d1d-91e1-6f5e509f44ae 48951-1112 HUMAN OTC DRUG Arnica Aurum Equisetum Arnica Aurum Equisetum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; EQUISETUM ARVENSE TOP; GOLD 3; 15; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1113_a7a149df-c649-4a6a-8c40-5ae9ab73c437 48951-1113 HUMAN OTC DRUG Arnica Berberis Teucrium Arnica Berberis Teucrium PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; TEUCRIUM SCORODONIA WHOLE 4; 2; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1114_0c719432-7d36-4567-bcc3-c2c05686a0c5 48951-1114 HUMAN OTC DRUG Arnica Betula A Arnica Betula A LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; BOS TAURUS BRAIN; BOS TAURUS CEREBELLUM; BOS TAURUS EYE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; COLLOIDAL SILICON DIOXIDE; HONEY; LEAD; SUS SCROFA THALAMUS 30; 4; 3; 17; 17; 17; 17; 17; 30; 30; 30; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1115_82c9c85a-0fd6-436f-9e1e-7df2fd28310d 48951-1115 HUMAN OTC DRUG Arnica Betula A Arnica Betula A PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; BOS TAURUS BRAIN; BOS TAURUS CEREBELLUM; BOS TAURUS EYE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; COLLOIDAL SILICON DIOXIDE; LEAD; SUS SCROFA THALAMUS 30; 4; 3; 17; 17; 17; 17; 17; 30; 30; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1116_c2fc1d2c-1c29-4e96-b2f3-4f293955af50 48951-1116 HUMAN OTC DRUG Arnica Betula B Arnica Betula B LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; BIFENTHRIN; BOS TAURUS BRAIN; BOS TAURUS CEREBELLUM; BOS TAURUS NERVE; BOS TAURUS PINEAL GLAND; HONEY; LEAD; SUS SCROFA EAR 30; 4; 3; 30; 17; 17; 17; 17; 30; 30; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1117_9a3c13aa-f381-4727-81a1-8326d9a2150c 48951-1117 HUMAN OTC DRUG Arnica Betula B Arnica Betula B PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; BIFENTHRIN; BOS TAURUS BRAIN; BOS TAURUS CEREBELLUM; BOS TAURUS NERVE; BOS TAURUS PINEAL GLAND; HONEY; LEAD; SUS SCROFA EAR 30; 4; 3; 30; 17; 17; 17; 17; 30; 30; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1119_7ca32a07-095d-471b-a997-9115a6567f6f 48951-1119 HUMAN OTC DRUG Arnica Calendula Essence Arnica Calendula Essence LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWERING TOP 1; 1 [hp_X]/mL; [hp_X]/mL 48951-1122_fceabd54-8548-4794-80c0-d1d15c376ed8 48951-1122 HUMAN OTC DRUG Arnica e pl. tota 12 Arnica e pl. tota 12 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 12 [hp_X]/1 48951-1123_075ae64a-5533-4246-a5f0-c318c887d1ac 48951-1123 HUMAN OTC DRUG Arnica e pl. tota 2 Arnica e pl. tota 2 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 2 [hp_X]/1 48951-1124_c76431e5-ab9c-4271-84b4-2fad95c24dd0 48951-1124 HUMAN OTC DRUG Arnica e pl. tota 20 Arnica e pl. tota 20 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 20 [hp_X]/mL 48951-1125_d1a99ca9-d05e-49a4-b035-6a0090026e7b 48951-1125 HUMAN OTC DRUG Arnica e pl. tota 20 Special Order Arnica e pl. tota 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 20 [hp_X]/mL 48951-1126_5d22045e-de63-456d-a92a-7badecda93b6 48951-1126 HUMAN OTC DRUG Arnica e pl. tota 3 Arnica e pl. tota 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 3 [hp_X]/mL 48951-1128_68b637aa-3cf0-4ddb-b7b7-92d30006af5a 48951-1128 HUMAN OTC DRUG Arnica e pl. tota 3 Arnica e pl. tota 3 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 3 [hp_X]/1 48951-1129_40447f02-7b56-4999-8982-fb9a5afda5f2 48951-1129 HUMAN OTC DRUG Arnica e pl. tota 30 Arnica e pl. tota 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 30 [hp_X]/mL 48951-1131_a20be09b-12ac-4de9-b3e9-469b3c39b05d 48951-1131 HUMAN OTC DRUG Arnica e pl. tota 30 Arnica e pl. tota 30 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 30 [hp_X]/1 48951-1132_80f4c47f-4679-470f-9cca-937b2870f0bc 48951-1132 HUMAN OTC DRUG Arnica e pl. tota 6 Arnica e pl. tota 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 6 [hp_X]/mL 48951-1134_7e53a427-4216-4142-8f80-88b25588a33c 48951-1134 HUMAN OTC DRUG Arnica e pl. tota 6 Arnica e pl. tota 6 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 6 [hp_X]/1 48951-1135_22928ea8-198b-489f-81ea-58e4b25081ad 48951-1135 HUMAN OTC DRUG Arnica e rad. 12 Arnica e rad. 12 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA ROOT 12 [hp_X]/1 48951-1136_3b5c07cd-3c77-402e-aac1-a33c5214a055 48951-1136 HUMAN OTC DRUG Arnica e rad. 20 Arnica e rad. 20 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA ROOT 20 [hp_X]/mL 48951-1137_f1656af6-affb-4f57-8c43-94dc831e58b1 48951-1137 HUMAN OTC DRUG Arnica e rad. 6 Special Order Arnica e rad. 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA ROOT 6 [hp_X]/1 48951-1139_8a771d63-7bb0-427d-8558-2763f2fa6b9a 48951-1139 HUMAN OTC DRUG Arnica e rad. 30 Arnica e rad. 30 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA ROOT 30 [hp_X]/1 48951-1141_fcd03114-494f-4842-a5aa-cd8235dba6b4 48951-1141 HUMAN OTC DRUG Arnica Echinacea Arnica Echinacea LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA LEAF; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; ST. JOHN'S WORT 6; 6; 6; 6; 5; 9; 6; 9; 5; 5; 6; 9; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1144_9185daed-ff11-4df7-ad34-fbea5c35be73 48951-1144 HUMAN OTC DRUG Arnica Arnica LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA FLOWER 1 [hp_X]/mL 48951-1145_f04473b5-70af-4b02-9b8b-0f6f36e672df 48951-1145 HUMAN OTC DRUG Arnica 10% First Aid Arnica 10% First Aid GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA FLOWER 1 [hp_X]/g 48951-1146_c9e3daf7-7e1f-4e7f-93d4-70b0e315d881 48951-1146 HUMAN OTC DRUG Arnica Forte Arnica Forte GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA FLOWER 1 [hp_X]/g 48951-1148_883ddf1c-2a28-4712-9b21-0f18c498408e 48951-1148 HUMAN OTC DRUG Arnica Nettle Burn and Bite Arnica Nettle Burn and Bite GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; LARIX DECIDUA RESIN; LYTTA VESICATORIA; SILVER; THUJA OCCIDENTALIS WHOLE; URTICA URENS 2; 2; 2; 3; 6; 7; 2; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-1149_769b7aa0-31ca-11df-9aae-0800200c9a66 48951-1149 HUMAN OTC DRUG Arnica Nettle Burn and Bite URTICA URENS CALENDULA OFFICINALIS FLOWERING TOP ARNICA MONTANA FLOWER COMFREY THUJA OCCIDENTALIS TWIG LYTTA VESICATORIA SILVER SPRAY TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY; LYTTA VESICATORIA; SILVER; THUJA OCCIDENTALIS TWIG; URTICA URENS 2; 2; 2; 7; 7; 2; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1150_a955eebd-bb38-4e7a-9f25-761ec469b7e0 48951-1150 HUMAN OTC DRUG Arinica Nettle Essence Arnica Nettle Essence LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; LYTTA VESICATORIA; SILVER; THUJA OCCIDENTALIS WHOLE; URTICA URENS 1; 1; 1; 7; 7; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1152_7139efe5-2bf3-403e-bec0-f8331e65f40c 48951-1152 HUMAN OTC DRUG Arnica Plumbum Mel Arnica Plumbum Mel LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; HONEY; LEAD 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1153_c7c8f39d-8f95-4810-b4f0-e0da6d4286d8 48951-1153 HUMAN OTC DRUG Arnica Plumbum Mel Arnica Plumbum Mel PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; HONEY; LEAD 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1154_d275156d-2c1a-459e-a18a-f98cf5e65573 48951-1154 HUMAN OTC DRUG Arnica Retina Arnica Retina LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BOS TAURUS EYE; EQUISETUM ARVENSE TOP 20; 10; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1155_72e10e4b-8bcd-4d77-b7aa-dc4be6946515 48951-1155 HUMAN OTC DRUG Arnica Scorodite Arnica Scorodite LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BOS TAURUS CEREBELLUM; COLLOIDAL SILICON DIOXIDE; FERROUS ARSENATE; FLUORAPATITE; LEVISTICUM OFFICINALE ROOT; ORCHIS MASCULA TUBER; OSTREA EDULIS SHELL; SODIUM CARBONATE 6; 8; 6; 7; 7; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1156_4d8a03ff-5934-49ca-a4d0-657eb639ba57 48951-1156 HUMAN OTC DRUG Arnica Scorodite Arnica Scorodite PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BOS TAURUS CEREBELLUM; COLLOIDAL SILICON DIOXIDE; FERROUS ARSENATE; FLUORAPATITE; LEVISTICUM OFFICINALE ROOT; ORCHIS MASCULA TUBER; OSTREA EDULIS SHELL; SODIUM CARBONATE 6; 8; 6; 7; 7; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1157_63e41607-883e-414a-b9c8-580e9f56f5ea 48951-1157 HUMAN OTC DRUG Arnica Stannum Arnica Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BOS TAURUS BONE; BOS TAURUS TENDON; COMFREY ROOT; ONION; RUTA GRAVEOLENS FLOWERING TOP; TIN 6; 17; 17; 6; 6; 6; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1158_df29e788-43b1-4f6b-8a21-2b2fe23378a2 48951-1158 HUMAN OTC DRUG Arnica Stannum Arnica Stannum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BOS TAURUS BONE; BOS TAURUS TENDON; COMFREY ROOT; ONION; RUTA GRAVEOLENS FLOWERING TOP; TIN 6; 17; 17; 6; 6; 6; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1160_d90729b8-1a01-4727-9ea5-1bcd355a53f2 48951-1160 HUMAN OTC DRUG Arsenicum album 30 Special Order Arsenicum album 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARSENIC TRIOXIDE 30 [hp_X]/mL 48951-1161_33c255dc-0f34-4fa1-9982-030228b2bea7 48951-1161 HUMAN OTC DRUG Arsenicum album 30 Arsenicum album 30 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARSENIC TRIOXIDE 30 [hp_X]/1 48951-1162_02cf3372-d255-4ee7-b13d-97a6212af9e0 48951-1162 HUMAN OTC DRUG Arsenicum album 6 Special Order Arsenicum album 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARSENIC TRIOXIDE 6 [hp_X]/mL 48951-1163_5df0208e-181a-478b-a085-24a76e7e53ff 48951-1163 HUMAN OTC DRUG Arsenicum Cerebrum Arsenicum Cerebrum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA ROOT; ARSENIC TRIOXIDE; BOS TAURUS BRAIN; BOS TAURUS FRONTAL LOBE; SILVER SULFIDE; SUS SCROFA TEMPORAL LOBE 6; 30; 8; 8; 20; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1164_cabc0436-437f-465c-86b7-2d3d155edf8c 48951-1164 HUMAN OTC DRUG Arsenicum Cerebrum Arsenicum Cerebrum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY PENTASULFIDE; ARNICA MONTANA ROOT; ARSENIC TRIOXIDE; BOS TAURUS BRAIN; BOS TAURUS FRONTAL LOBE 20; 6; 30; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-1167_39448043-f5b4-4df9-bf0f-09ba8e07a3d7 48951-1167 HUMAN OTC DRUG Articulatio Coxae 8 Articulatio Coxae 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF 8 [hp_X]/mL 48951-1168_84b15eec-8eaa-4f21-90d0-a01ff1899527 48951-1168 HUMAN OTC DRUG Articulatio genus 8 Articulatio genus 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF 8 [hp_X]/mL 48951-1169_cb24aaa1-8520-46fd-afcb-893be6dc8f8a 48951-1169 HUMAN OTC DRUG Articulatio humeri 6 Special Order Articulatio humeri 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS JOINT CAPSULE 6 [hp_X]/mL 48951-1170_6b773b14-dbeb-461a-838d-600e2c7a52bc 48951-1170 HUMAN OTC DRUG Articulatio interphalangea 17 Special Order Articulatio interphalangea 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF 17 [hp_X]/mL 48951-1171_4e5cb9f9-e3fb-4185-afdd-1334a01964c5 48951-1171 HUMAN OTC DRUG Astragalus Arnica Astragalus Arnica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; ASTRAGALUS PROPINQUUS ROOT 30; 3 [hp_X]/mL; [hp_X]/mL 48951-1172_89b9af2b-a923-4e7c-a5db-b77488b36f3c 48951-1172 HUMAN OTC DRUG Astragalus e rad. 1% Astragalus e rad. 1% LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ASTRAGALUS PROPINQUUS ROOT 2 [hp_X]/mL 48951-1173_5beb2f7b-7589-4688-bfeb-c6ca7d9ae67b 48951-1173 HUMAN OTC DRUG Astragalus e rad. 3 Astragalus e rad. 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ASTRAGALUS PROPINQUUS ROOT 3 [hp_X]/mL 48951-1174_cd219848-67a8-4f9e-aea6-890006444c58 48951-1174 HUMAN OTC DRUG Astragalus Formica Astragalus Formica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; ASTRAGALUS PROPINQUUS ROOT; FORMICA RUFA; SILVER 3; 3; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1175_06bf7416-0111-400d-912f-da372ad4d032 48951-1175 HUMAN OTC DRUG Aurum 12 Special Order Aurum 12 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD 12 [hp_X]/mL 48951-1177_f26629f4-390c-46da-9cbd-cf0a1eb90c81 48951-1177 HUMAN OTC DRUG Aurum 20 Aurum 20 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD 20 [hp_X]/mL 48951-1178_b4b0c867-5b60-4062-af4a-89ce62fd3756 48951-1178 HUMAN OTC DRUG Aurum 30 Aurum 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD 30 [hp_X]/mL 48951-1180_26fd5d1e-0728-47cf-af11-20263cbc6c64 48951-1180 HUMAN OTC DRUG Aurum 5 Aurum 5 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD 5 [hp_X]/g 48951-1181_45c8bedf-89e3-4088-8ea6-ad17cf54b73a 48951-1181 HUMAN OTC DRUG Aurum 6 Aurum 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD 6 [hp_X]/mL 48951-1182_d6acd645-b5bc-42b8-bd3b-aa82e9ad154d 48951-1182 HUMAN OTC DRUG Aurum 6 Aurum 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD 6 [hp_X]/mL 48951-1184_80651f39-415e-47ae-b875-164fc5cbb94a 48951-1184 HUMAN OTC DRUG Aurum Crataegus Aurum Crataegus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CAMPHOR (NATURAL); GOLD; HAWTHORN LEAF WITH FLOWER; SELENICEREUS GRANDIFLORUS STEM; STROPHANTHUS KOMBE WHOLE; TARAXACUM PALUSTRE ROOT; VALERIAN 4; 10; 3; 4; 6; 2; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1185_8b26d32d-4b30-4cd5-96af-3c8badc65095 48951-1185 HUMAN OTC DRUG Aurum Crataegus Nausea Relief TARAXACUM OFFICINALE - HAWTHORN LEAF WITH FLOWER - VALERIAN - SELENICEREUS GRANDIFLORUS STEM - CAMPHOR (SYNTHETIC) - STROPHANTHUS HISPIDUS SEED - GOLD - PELLET ORAL 20091201 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc CAMPHOR (SYNTHETIC); GOLD; HAWTHORN LEAF WITH FLOWER; SELENICEREUS GRANDIFLORUS STEM; STROPHANTHUS HISPIDUS SEED; TARAXACUM OFFICINALE; VALERIAN 4; 10; 3; 4; 6; 2; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1186_12c8f896-25eb-420f-88d7-990b6ba952af 48951-1186 HUMAN OTC DRUG Aurum Equisetum A Aurum Equisetum A LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; EQUISETUM ARVENSE TOP; GOLD; PORK KIDNEY 8; 17; 10; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1187_59f57170-262b-4fae-8410-d01a89e57265 48951-1187 HUMAN OTC DRUG Aurum Equisetum A Aurum Equisetum A PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; EQUISETUM ARVENSE TOP; GOLD; PORK KIDNEY 8; 17; 10; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1188_b71ee536-d2c4-49b1-9565-0ce69f04a8aa 48951-1188 HUMAN OTC DRUG Aurum Equisetum B Aurum Equisetum B LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; GOLD 17; 30 [hp_X]/mL; [hp_X]/mL 48951-1189_a8e0dcba-0a9d-409d-a588-251fee20f353 48951-1189 HUMAN OTC DRUG Aurum Equisetum B Aurum Equisetum B PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; GOLD 17; 30 [hp_X]/1; [hp_X]/1 48951-1190_28ff7e80-d305-4373-b14f-001a7c7c6601 48951-1190 HUMAN OTC DRUG Aurum Hypericum Aurum Hypericum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AVENA SATIVA FLOWERING TOP; GOLD TRICHLORIDE; MAGNESIUM HYDROXIDE; MAMMAL LIVER; PHOSPHORIC ACID; ROYAL JELLY; SILICON DIOXIDE; ST. JOHN'S WORT; STRYCHNOS IGNATII SEED 3; 7; 4; 4; 5; 6; 7; 3; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1191_1c632f8c-6596-472d-8756-2e72c69cc3f8 48951-1191 HUMAN OTC DRUG Aurum Hypericum Overwhelm Relief OAT HYPERICUM PERFORATUM PHOSPHORIC ACID MAMMAL LIVER STRYCHNOS IGNATII SEED MAGNESIUM APIS MELLIFERA SILICON DIOXIDE GOLD TRICHLORIDE PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc APIS MELLIFERA; GOLD TRICHLORIDE; HYPERICUM PERFORATUM; MAGNESIUM; MAMMAL LIVER; OAT; PHOSPHORIC ACID; SILICON DIOXIDE; STRYCHNOS IGNATII SEED 6; 7; 3; 5; 5; 3; 5; 7; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1192_d27d96ad-7385-4eed-95a4-6f7491894631 48951-1192 HUMAN OTC DRUG Aurum Hypericum Stibium Aurum Hypericum Stibium PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; GOLD; ST. JOHN'S WORT 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1194_823ff8c0-4194-11df-9879-0800200c9a66 48951-1194 HUMAN OTC DRUG Aurum Lavender Rose HORSE CHESTNUT EQUISETUM ARVENSE TOP HYPERICUM PERFORATUM GOLD MYRRH CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc EQUISETUM ARVENSE TOP; GOLD; HORSE CHESTNUT; HYPERICUM PERFORATUM; MYRRH 2; 5; 2; 3; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1195_de80e65b-1cca-4b7c-b257-5d13251913f6 48951-1195 HUMAN OTC DRUG Aurum Lavender Rose Aurum Lavender Rose OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; FRANKINCENSE; GOLD; HORSE CHESTNUT; MYRRH; ST. JOHN'S WORT 3; 10; 13; 3; 10; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-1196_2a34b289-f5d7-4f04-9835-7913d374e9f4 48951-1196 HUMAN OTC DRUG Aurum Olibanum Myrrha Aurum Olibanum Myrrha LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FRANKINCENSE; GOLD; MYRRH 7; 10; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1197_8ef0aac0-e676-11de-8a39-0800200c9a66 48951-1197 HUMAN OTC DRUG Threefold Balance MYRRH GOLD PELLET ORAL 20091201 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc GOLD; MYRRH 10; 7 [hp_X]/1; [hp_X]/1 48951-1198_d5a47a6f-728f-461c-9ae4-193b078bc92a 48951-1198 HUMAN OTC DRUG Threefold Balance Threefold Balance TABLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FRANKINCENSE; GOLD; MYRRH 2; 6; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1199_e7d52051-120a-44fa-86e3-542c0021a398 48951-1199 HUMAN OTC DRUG Aurum Onopordon Aurum Onopordon LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; FORMICA RUFA; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 10; 10; 10; 4; 2; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1200_cde3d32a-a855-46b6-a583-2c8d9e97b5e3 48951-1200 HUMAN OTC DRUG Aurum Plumbum Aurum Plumbum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; GOLD; HONEY; LEAD 10; 10; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1202_14fbd34d-c5fc-4118-b07c-6de979a98d82 48951-1202 HUMAN OTC DRUG Aurum Prunus Aurum Prunus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD; SLOE 10; 6 [hp_X]/mL; [hp_X]/mL 48951-1203_bad7ba26-c1a0-4fd5-9581-83056b7d567a 48951-1203 HUMAN OTC DRUG Aurum Prunus Aurum Prunus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD; SLOE 10; 6 [hp_X]/mL; [hp_X]/mL 48951-1204_daf3e224-a282-4346-aaea-5f2856996c39 48951-1204 HUMAN OTC DRUG Aurum Prunus Aurum Prunus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD; SLOE 10; 6 [hp_X]/1; [hp_X]/1 48951-1205_39677402-62a6-44d4-b555-bdb016330626 48951-1205 HUMAN OTC DRUG Aurum Stibium Hyoscyamus Aurum Stibium Hyoscyamus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 8; 10; 4; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1206_4ce118ba-4f64-4d78-b432-6b39eff4c010 48951-1206 HUMAN OTC DRUG AURUM STIBIUM HYOSCYAMUS AURUM STIBIUM HYOSCYAMUS LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC URIEL PHARMACY INC. ANTIMONY; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 8; 10; 4; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1208_ecbab638-b0c6-49c8-82c8-fa48f06e6b5c 48951-1208 HUMAN OTC DRUG Aurum Stibium Special Order Aurum Stibium Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; GOLD 8; 10 [hp_X]/1; [hp_X]/1 48951-1209_b9e94232-f166-4bd1-8264-a5c9a93aa8d1 48951-1209 HUMAN OTC DRUG Aurum Strophanthus Aurum Strophanthus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD; STROPHANTHUS KOMBE WHOLE 12; 6 [hp_X]/mL; [hp_X]/mL 48951-1210_bda56cdd-f068-4624-8d7d-c6618f0c8e34 48951-1210 HUMAN OTC DRUG Aurum Strophanthus Special Order Aurum Strophanthus Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER; STROPHANTHUS KOMBE WHOLE 12; 6 [hp_X]/1; [hp_X]/1 48951-1211_4786bc9e-366e-4435-b523-ab477450c70c 48951-1211 HUMAN OTC DRUG Avena Valeriana Avena Valeriana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AVENA SATIVA FLOWERING TOP; OSTREA EDULIS SHELL; PHOSPHORUS; SULFUR; VALERIAN 6; 7; 30; 30; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1212_daa2ab02-a3a0-4940-99d4-d130fd8f6998 48951-1212 HUMAN OTC DRUG Avena Valeriana Nerve Relief OAT VALERIAN ROOT OYSTER SHELL CALCIUM CARBONATE, CRUDE PHOSPHORUS SULFUR PELLET ORAL 20091201 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc OAT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SULFUR; VALERIAN ROOT 3; 7; 30; 30; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1213_76d68e05-4d4b-4d49-86b9-53a944f2683b 48951-1213 HUMAN OTC DRUG Arnica Rosa Arnica Rosa LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BOS TAURUS BRAIN; BOS TAURUS EYE; BOS TAURUS NERVE; COLLOIDAL SILICON DIOXIDE 17; 7; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1214_2b138456-7b59-4db5-9225-25ec182d6235 48951-1214 HUMAN OTC DRUG Apis Belladonna Mercurius Apis Belladonna Mercurius LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA; MERCURIUS SOLUBILIS 5; 4; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1215_ed19a97b-a170-4e9f-8ec4-0e4dd34a0a55 48951-1215 HUMAN OTC DRUG Argentum Bryophyllum Special Order Argentum Bryophyllum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; SILVER 6; 10 [hp_X]/mL; [hp_X]/mL 48951-1216_350e5063-bdea-4c8a-b33f-7be10d54d485 48951-1216 HUMAN OTC DRUG Aurum 17 Special Order Aurum 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD 17 [hp_X]/mL 48951-1217_36e9c56e-4cc7-42ce-9752-89ffae73cc0d 48951-1217 HUMAN OTC DRUG Apis Belladonna Special Order Apis Belladonna Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA 3; 3 [hp_X]/mL; [hp_X]/mL 48951-1218_914c9834-8883-4612-80c7-f1e6d9e7fbfb 48951-1218 HUMAN OTC DRUG Arnica Nettle Burn and Bite Special Order Arnica Nettle Burn and Bite Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; LARIX DECIDUA RESIN; LYTTA VESICATORIA; SILVER; THUJA OCCIDENTALIS WHOLE; URTICA URENS 1; 2; 2; 2; 7; 8; 2; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-1219_36beb024-28eb-4621-90df-225af0a30a39 48951-1219 HUMAN OTC DRUG Agaricus muscarius 30 Special Order Agaricus muscarius 30 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMANITA MUSCARIA FRUITING BODY 30 [hp_X]/1 48951-1220_9fb97589-ee90-4f64-890f-721ca7ee7991 48951-1220 HUMAN OTC DRUG Argentite Urtica Special Order Argentite Urtica Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PITUITARY GLAND; BOS TAURUS TESTICLE; ROYAL JELLY; SAW PALMETTO; SILVER SULFIDE; URTICA DIOICA 6; 6; 6; 4; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1221_96db8473-13b7-40e4-a77d-846d23a4e08e 48951-1221 HUMAN OTC DRUG Argentum 0.4 Adult Size (cocoa butter) Special Order Argentum 0.4 Adult Size (cocoa butter) Special Order SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 1 [hp_X]/g 48951-1222_e3cb9435-c586-448e-956f-b053b0e90038 48951-1222 HUMAN OTC DRUG Agaricus Equisetum Special Order Agaricus Equisetum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMANITA MUSCARIA FRUITING BODY; COLLOIDAL SILICON DIOXIDE; DRYOPTERIS FILIX-MAS ROOT; EQUISETUM ARVENSE TOP; HONEY; LEAD; OSTREA EDULIS SHELL; PHOSPHORUS; SILVER FLUORIDE 8; 4; 3; 4; 20; 20; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1223_6702a2d7-bc52-4e87-b8af-919ddc14012e 48951-1223 HUMAN OTC DRUG Apis Bryonia Special Order Apis Bryonia Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BRYONIA ALBA ROOT 3; 3 [hp_X]/mL; [hp_X]/mL 48951-1224_f32bdc5c-8ad9-489f-b73b-c133d1c80c5f 48951-1224 HUMAN OTC DRUG Astragalus Formica Special Order Astragalus Formica Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; ASTRAGALUS PROPINQUUS ROOT; FORMICA RUFA; SILVER 3; 3; 6; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1225_0a17b1f2-6b6d-4c97-ae1d-b85f461178cb 48951-1225 HUMAN OTC DRUG Argentum 8 Special Order Argentum 8 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 8 [hp_X]/1 48951-1226_eaec21ae-143c-43a6-a324-0a38b02991d9 48951-1226 HUMAN OTC DRUG Apis Eucalyptus Special Order Apis Eucalyptus Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA; EUCALYPTUS GUM 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1227_d68c26f9-2fb6-4eb9-bc8f-5617529b183e 48951-1227 HUMAN OTC DRUG Arnica Apis Nervus trigeminus Special Order Arnica Apis Nervus trigeminus Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ARNICA MONTANA; BOS TAURUS NERVE 20; 20; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1228_4da66ece-b0a4-453d-aba0-1c82a3c07225 48951-1228 HUMAN OTC DRUG Arnica Aurum 15/10 Special Order Arnica Aurum 15/10 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; GOLD 15; 10 [hp_X]/mL; [hp_X]/mL 48951-1229_0a22df6d-972c-4ae0-a081-e5f375c38764 48951-1229 HUMAN OTC DRUG Aurum 30 Special Order Aurum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD 30 [hp_X]/mL 48951-1230_19e57b17-162a-43cb-aa94-301218af7776 48951-1230 HUMAN OTC DRUG Aurum Hypericum Stibium Special Order Aurum Hypericum Stibium Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; GOLD; ST. JOHN'S WORT 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1231_a5e7571c-c260-44df-8389-332562c3e9ca 48951-1231 HUMAN OTC DRUG Arnica Carbo Special Order Arnica Carbo Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL; ARNICA MONTANA ROOT; ATROPA BELLADONNA; LACHESIS MUTA VENOM; MELILOTUS INDICUS SEED 10; 6; 6; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1232_0d4b4781-4fea-4823-8254-4b6d45d63567 48951-1232 HUMAN OTC DRUG Argentum Vesica urinaria 8/5 Special Order Argentum Vesica urinaria 8/5 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER; SUS SCROFA URINARY BLADDER 8; 5 1/mL; [hp_X]/mL 48951-1233_0f5564b9-ebb3-4150-b828-88a220efeb6a 48951-1233 HUMAN OTC DRUG Arnica Aurum 3/30 Special Order Arnica Aurum 3/30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; GOLD 3; 30 [hp_X]/mL; [hp_X]/mL 48951-1234_d54cbdfa-b2dc-4d72-b7d9-e34bf7aa26d9 48951-1234 HUMAN OTC DRUG Argentum carbonicum 6 Special Order Argentum carbonicum 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER CARBONATE 6 [hp_X]/mL 48951-1235_b7bee05c-ed34-489c-afa8-7efe971e9435 48951-1235 HUMAN OTC DRUG Apis ex animale 4 Special Order Apis ex animale 4 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA 4 [hp_X]/mL 48951-1236_ec38f1ac-6c97-4502-adab-4f0b6c996f12 48951-1236 HUMAN OTC DRUG Aconitum e tub. 6 Special Order Aconitum e tub. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS 6 [hp_X]/mL 48951-1237_e9f07804-72c3-410f-b91c-37120e3e7731 48951-1237 HUMAN OTC DRUG Apis ex animale 3 Special Order Apis ex animale 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA 3 [hp_X]/mL 48951-1238_e9cfc22c-89a2-4afb-916b-75698ba5830b 48951-1238 HUMAN OTC DRUG Argentum nitricum 6 Special Order Argentum nitricum 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 6 [hp_X]/mL 48951-1239_0cad9075-7160-4c26-a523-ba025fdc8af4 48951-1239 HUMAN OTC DRUG Archangelica 3 Special Order Archangelica 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANGELICA ARCHANGELICA ROOT 3 [hp_X]/mL 48951-1240_200b5ad6-de7c-4be8-8684-35bc6b36e17e 48951-1240 HUMAN OTC DRUG Absinthium ex herba 1 Special Order Absinthium ex herba 1 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. WORMWOOD 2 [hp_X]/mL 48951-1241_d2c2886a-e690-4964-b167-ec2551b4840e 48951-1241 HUMAN OTC DRUG Antimonite Echincea Special Order Antimonite Echincea Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY TRISULFIDE; BEEF; BOS TAURUS OVARY; ECHINACEA, UNSPECIFIED; SUS SCROFA FALLOPIAN TUBE 8; 6; 6; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1242_6283a778-42b5-4897-bfa6-5100c510b89a 48951-1242 HUMAN OTC DRUG Apis Phosphorus Special Order Apis Phosphorus Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; PHOSPHORUS; SILVER SULFIDE 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1243_0c21badc-25ef-49e9-a2eb-17135e9131df 48951-1243 HUMAN OTC DRUG Aurum Stibium Special Order Aurum Stibium Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COMFREY ROOT; GOLD 8; 10 [hp_X]/mL; [hp_X]/mL 48951-1244_d10bd1ca-fd5f-4d01-8f4e-854ae044c16b 48951-1244 HUMAN OTC DRUG Aesculinum 30 Special Order Aesculinum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ESCULIN 30 [hp_X]/mL 48951-1245_62111f3e-e3d4-478d-9cd5-522351137523 48951-1245 HUMAN OTC DRUG Arnica Stannum Special Order Arnica Stannum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BOS TAURUS BONE; BOS TAURUS TENDON; COMFREY ROOT; ONION; RUTA GRAVEOLENS FLOWERING TOP; TIN 6; 17; 17; 6; 6; 6; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1247_7005c780-f23e-44ae-ae10-27d3a8a5aaa4 48951-1247 HUMAN OTC DRUG Aurum Ferrum sidereum 10/10 Special Order Aurum Ferrum sidereum 10/10 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD; IRON 10; 10 [hp_X]/mL; [hp_X]/mL 48951-1248_1d9aea5d-d995-4d1a-83bf-83dbb09291ce 48951-1248 HUMAN OTC DRUG Arnica Calendula Special Order Arnica Calendula Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWERING TOP; COLLOIDAL SILICON DIOXIDE; ECHINACEA ANGUSTIFOLIA 1; 1; 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-1249_dbd15d60-6475-4ae5-b675-22e6b522ccde 48951-1249 HUMAN OTC DRUG Aconitum e tub. 30 Special Order Aconitum e tub. 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS 30 [hp_X]/mL 48951-1250_e4279a22-e8ad-4343-9dbe-7f2d46837643 48951-1250 HUMAN OTC DRUG Aurum Equisetum 10/15 Special Order Aurum Equisetum 10/15 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; GOLD 15; 10 [hp_X]/mL; [hp_X]/mL 48951-1251_39ada185-e66a-454a-86f2-a136aba56d9d 48951-1251 HUMAN OTC DRUG Apis ex animale 20 Special Order Apis ex animale 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA 20 [hp_X]/mL 48951-1252_2e441193-e147-4545-af30-8cdd7a136263 48951-1252 HUMAN OTC DRUG Arnica Retina Quartz Special Order Arnica Retina Quartz Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY TRISULFIDE; ARNICA MONTANA; BOS TAURUS EYE; COLLOIDAL SILICON DIOXIDE; EQUISETUM ARVENSE TOP 10; 20; 10; 12; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1253_710a1125-9ee1-42eb-8d4c-3c7976a35694 48951-1253 HUMAN OTC DRUG Achillea Millefolium 10 Special Order Achillea Millefolium 10 Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACHILLEA MILLEFOLIUM 1 [hp_X]/g 48951-1255_d993ee00-a601-454c-9985-f5c6b68f6130 48951-1255 HUMAN OTC DRUG Aconitum e tub. 6 Special Order Aconitum e tub. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS 6 [hp_X]/mL 48951-1256_791f82e4-a93c-4562-bc23-404b3dca16b7 48951-1256 HUMAN OTC DRUG Allium Cuprum comp. Special Order Allium Cuprum comp. Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC SULFATE; GARLIC; ONION 3; 2; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1257_126b6f08-531a-453b-9224-6a4622385f0d 48951-1257 HUMAN OTC DRUG Apis ex animale 30 Special Order Apis ex animale 30 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA 30 [hp_X]/1 48951-1258_35b80602-d2eb-4426-9240-6d622c0d54d1 48951-1258 HUMAN OTC DRUG Arnica Echinacea Special Order Arnica Echinacea Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ARNICA MONTANA FLOWER; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA LEAF; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; ST. JOHN'S WORT 8; 8; 8; 3; 8; 7; 11; 3; 11; 3; 7; 7; 8; 11; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1259_ade091de-be74-4c21-a30d-c38dda9500e0 48951-1259 HUMAN OTC DRUG Arsenicum Cerebrum Special Order Arsenicum Cerebrum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA ROOT; ARSENIC TRIOXIDE; BOS TAURUS BRAIN; BOS TAURUS FRONTAL LOBE; SILVER SULFIDE; SUS SCROFA TEMPORAL LOBE 6; 30; 8; 8; 20; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-1260_789dea19-ec15-48eb-b185-25a2c3e84b05 48951-1260 HUMAN OTC DRUG Artemesia absinthium 5 Special Order Artemesia absinthium 5 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. WORMWOOD 1 [hp_X]/mL 48951-1261_91b900e3-ebfc-4d06-ba09-af9001ec6e6c 48951-1261 HUMAN OTC DRUG Arum maculatum Pteridium 5/5 Special Order Arum maculatum Pteridium 5/5 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARUM MACULATUM ROOT; PTERIDIUM AQUILINUM WHOLE 5; 5 [hp_X]/mL; [hp_X]/mL 48951-1262_f1ff416b-0567-4259-a0fc-5856b7ab0238 48951-1262 HUMAN OTC DRUG Aurum Belladonna Special Order Aurum Belladonna Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; FRANKINCENSE; GOLD; MYRRH 8; 7; 10; 7 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-1263_18ea4f41-5da9-42a0-a7bd-2e92643b05eb 48951-1263 HUMAN OTC DRUG Aconitum Bryonia Child Size Special Order Aconitum Bryonia Child Size Special Order SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; EUCALYPTUS GUM; EUPATORIUM CANNABINUM; QUILLAJA SAPONARIA BARK; SILVER 5; 3; 5; 2; 4; 4; 4; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-2001_2157e499-2787-42d8-b9ee-c7d93a92be7c 48951-2001 HUMAN OTC DRUG Bamboo Rosemary Bamboo Rosemary CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; EQUISETUM ARVENSE TOP; FORMICA RUFA; ROSEMARY OIL; TIN; VISCUM ALBUM FRUITING TOP 3; 5; 3; 5; 2; 7; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-2002_a6a470d0-da5b-48aa-bf12-6058ce2ebaa2 48951-2002 HUMAN OTC DRUG Bambusa Aesculus Bambusa Aesculus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; COLLOIDAL SILICON DIOXIDE; FORMICA RUFA; HORSE CHESTNUT; ROSMARINUS OFFICINALIS FLOWERING TOP; STACHYS OFFICINALIS 20; 6; 8; 12; 7; 50; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2003_4596b5b7-cf07-40ff-936e-c55cf9390a5a 48951-2003 HUMAN OTC DRUG BAMBUSA AESCULUS BAMBUSA AESCULUS GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC URIEL PHARMACY INC. ARNICA MONTANA; BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; FORMICA RUFA; HORSE CHESTNUT; ROSMARINUS OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; STACHYS OFFICINALIS 20; 6; 8; 7; 50; 6; 12; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-2004_60ac417a-355c-44bb-9ac9-41ed832a17f4 48951-2004 HUMAN OTC DRUG Bambusa Aesculus Bambusa Aesculus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; COLLOIDAL SILICON DIOXIDE; FORMICA RUFA; HORSE CHESTNUT; ROSMARINUS OFFICINALIS FLOWERING TOP; STACHYS OFFICINALIS 20; 6; 8; 12; 7; 50; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2005_a71de214-4daf-4a57-b789-42342ef52a88 48951-2005 HUMAN OTC DRUG Bambusa Argentum Bambusa Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; COLLOIDAL SILICON DIOXIDE; FORMICA RUFA; ROSMARINUS OFFICINALIS FLOWERING TOP; SILVER; STACHYS OFFICINALIS 20; 6; 8; 17; 7; 6; 20; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2006_5b6d9354-fe13-474d-a152-382a149621be 48951-2006 HUMAN OTC DRUG Bambusa Argentum Bambusa Argentum GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; COLLOIDAL SILICON DIOXIDE; COPPER; GOLD; ROSMARINUS OFFICINALIS FLOWERING TOP; SILVER; STACHYS OFFICINALIS 22; 8; 10; 19; 11; 9; 8; 22; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-2007_4cd01554-db7b-49b9-84be-f8cca6c35fbb 48951-2007 HUMAN OTC DRUG Bambusa Argentum Bambusa Argentum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; COLLOIDAL SILICON DIOXIDE; FORMICA RUFA; ROSMARINUS OFFICINALIS FLOWERING TOP; SILVER; STACHYS OFFICINALIS 20; 6; 8; 17; 7; 6; 20; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2009_089aa5ed-7a54-48a2-86bd-e09ac8aedf94 48951-2009 HUMAN OTC DRUG Bambusa Aurum Bambusa Aurum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; COLLOIDAL SILICON DIOXIDE; FORMICA RUFA; GOLD; ROSMARINUS OFFICINALIS FLOWERING TOP; STACHYS OFFICINALIS 20; 6; 6; 12; 5; 16; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2010_651d5692-230f-4c24-9f1b-318bcd068ce9 48951-2010 HUMAN OTC DRUG Bambusa Formica Bambusa Formica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BRAIN; BOS TAURUS CEREBELLUM; BOS TAURUS EYE; BOS TAURUS PITUITARY GLAND; COLLOIDAL SILICON DIOXIDE; FRANKINCENSE; MYRRH; SILVER; SUS SCROFA THALAMUS 8; 8; 8; 8; 8; 7; 7; 10; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2011_6bbeb11c-b45c-4369-a05e-da12f5f40551 48951-2011 HUMAN OTC DRUG Bambusa Nicotiana Bambusa Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; BOS TAURUS PITUITARY GLAND; COLLOIDAL SILICON DIOXIDE; EQUISETUM ARVENSE TOP; FORMICA RUFA; ROSMARINUS OFFICINALIS FLOWERING TOP; STACHYS OFFICINALIS; TIN; TOBACCO LEAF 6; 8; 8; 12; 15; 7; 6; 6; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2013_3963fdf1-1923-4254-9488-ad86445090d4 48951-2013 HUMAN OTC DRUG Bambusa Nicotiana Bambusa Nicotiana PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; BOS TAURUS PITUITARY GLAND; COLLOIDAL SILICON DIOXIDE; EQUISETUM ARVENSE TOP; FORMICA RUFA; ROSMARINUS OFFICINALIS FLOWERING TOP; STACHYS OFFICINALIS; TIN; TOBACCO LEAF 6; 8; 8; 12; 15; 7; 6; 6; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2014_e8ab1609-2b9d-472a-95aa-88bd36ccc05f 48951-2014 HUMAN OTC DRUG Bambusa Pulsatilla Bambusa Pulsatilla LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; COLLOIDAL SILICON DIOXIDE; EQUISETUM ARVENSE TOP; FERROSOFERRIC PHOSPHATE; FORMICA RUFA; PULSATILLA VULGARIS; ROSMARINUS OFFICINALIS FLOWERING TOP; STACHYS OFFICINALIS; TIN; VISCUM ALBUM FRUITING TOP 6; 6; 12; 5; 7; 5; 5; 6; 6; 7; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2015_e7b73eba-78bf-45f4-a42d-6434916e775a 48951-2015 HUMAN OTC DRUG Bambusa Pulsatilla Bambusa Pulsatilla PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; COLLOIDAL SILICON DIOXIDE; EQUISETUM ARVENSE TOP; FERROSOFERRIC PHOSPHATE; FORMICA RUFA; PULSATILLA VULGARIS; ROSMARINUS OFFICINALIS FLOWERING TOP; STACHYS OFFICINALIS; TIN; VISCUM ALBUM FRUITING TOP 6; 6; 12; 5; 7; 7; 5; 6; 6; 7; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2016_1161906f-1334-471e-a41b-f9349383bfac 48951-2016 HUMAN OTC DRUG Bambusa Rhus Bambusa Rhus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; COLLOIDAL SILICON DIOXIDE; FORMICA RUFA; GELSEMIUM SEMPERVIRENS ROOT; MANDRAGORA OFFICINARUM ROOT; PENOXSULAM; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; ROSMARINUS OFFICINALIS FLOWERING TOP; SILVER; STACHYS OFFICINALIS; TOXICODENDRON PUBESCENS LEAF 6; 20; 6; 8; 12; 7; 4; 6; 10; 4; 6; 20; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2017_3fbd6591-de2c-459a-95da-a5eb47e16011 48951-2017 HUMAN OTC DRUG Bambusa Rhus Bambusa Rhus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; FORMICA RUFA; GELSEMIUM SEMPERVIRENS ROOT; MANDRAGORA OFFICINARUM ROOT; PENOXSULAM; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; ROSMARINUS OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; SILVER; STACHYS OFFICINALIS; TOXICODENDRON PUBESCENS LEAF 6; 20; 6; 8; 7; 4; 6; 10; 4; 6; 12; 20; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2018_76737dc6-6696-4445-b2b2-dc1dee9852f0 48951-2018 HUMAN OTC DRUG Bambusa Stannum Bambusa Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; COLLOIDAL SILICON DIOXIDE; EQUISETUM ARVENSE TOP; FORMICA RUFA; ROSMARINUS OFFICINALIS FLOWERING TOP; STACHYS OFFICINALIS; TIN 6; 6; 12; 15; 7; 6; 6; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2019_94e072dd-c64c-41ba-90e0-3a17c426eacd 48951-2019 HUMAN OTC DRUG Bambusa Stannum Bambusa Stannum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; COLLOIDAL SILICON DIOXIDE; EQUISETUM ARVENSE TOP; FORMICA RUFA; ROSMARINUS OFFICINALIS FLOWERING TOP; STACHYS OFFICINALIS; TIN 6; 6; 12; 15; 7; 6; 6; 7 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2020_9c8ae9de-b2e9-49cb-9174-f753c502742e 48951-2020 HUMAN OTC DRUG Bambusa Stibium Bambusa Stibium LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; ARNICA MONTANA; BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; COLLOIDAL SILICON DIOXIDE; FORMICA RUFA; ROSMARINUS OFFICINALIS FLOWERING TOP; STACHYS OFFICINALIS 8; 20; 6; 6; 12; 7; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2021_679a67d5-7df7-4d31-a6a1-5a0189732035 48951-2021 HUMAN OTC DRUG Bambusa Stibium Bambusa Stibium PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; ARNICA MONTANA; BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; COLLOIDAL SILICON DIOXIDE; FORMICA RUFA; ROSMARINUS OFFICINALIS FLOWERING TOP; STACHYS OFFICINALIS 8; 20; 6; 6; 12; 7; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2023_2f550433-bd35-4f47-83f0-f51ba9ea2d7e 48951-2023 HUMAN OTC DRUG Bambusa Viscum Stannum Bambusa Viscum Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; COLLOIDAL SILICON DIOXIDE; EQUISETUM ARVENSE TOP; FORMICA RUFA; ROSMARINUS OFFICINALIS FLOWERING TOP; STACHYS OFFICINALIS; TIN; VISCUM ALBUM FRUITING TOP 6; 6; 12; 15; 5; 6; 6; 7; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2024_0b45ec2f-7fff-44d2-bbf2-5a14c0459b09 48951-2024 HUMAN OTC DRUG Bambusa Viscum Stannum Bambusa Viscum Stannum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; EQUISETUM ARVENSE TOP; FORMICA RUFA; ROSMARINUS OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; STACHYS OFFICINALIS; TIN; VISCUM ALBUM FRUITING TOP 6; 6; 15; 5; 6; 12; 6; 7; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2027_8c1eddb8-e799-4bb3-8997-46063b0d105a 48951-2027 HUMAN OTC DRUG Belladonna Betula Formica Belladonna Betula Formica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; BETULA PUBESCENS LEAF; FORMICA RUFA 6; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2030_529ee179-efe3-459c-8248-47c017bc4114 48951-2030 HUMAN OTC DRUG Belladonna ex herba 30 Belladonna ex herba 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA 30 [hp_X]/mL 48951-2031_571ae6c5-9c13-49f4-90cd-de18f6e1cfea 48951-2031 HUMAN OTC DRUG Belladonna ex herba 30 Special Order Belladonna ex herba 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA 30 [hp_X]/mL 48951-2033_4a3fb675-2925-40c3-b057-ddcb40838b96 48951-2033 HUMAN OTC DRUG Belladonna ex herba 6 Belladonna ex herba 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA 6 [hp_X]/mL 48951-2034_c3aed2c1-ced9-4557-b81e-cbbe60521059 48951-2034 HUMAN OTC DRUG Belladonna ex herba 6 Special Order Belladonna ex herba 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA 6 [hp_X]/mL 48951-2035_59a6ace3-f51d-4956-8b57-f4725dd1314f 48951-2035 HUMAN OTC DRUG Berberis Aurum Berberis Aurum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; BOS TAURUS PLACENTA; GOLD; KALANCHOE DAIGREMONTIANA LEAF; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; URTICA URENS 2; 8; 10; 3; 5; 4; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2036_563b0fc7-e6fb-4b24-a5d2-0df3bef6bc8a 48951-2036 HUMAN OTC DRUG Berberis Aurum Special Order Berberis Aurum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; BOS TAURUS PLACENTA; GOLD; KALANCHOE DAIGREMONTIANA LEAF; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; URTICA URENS 2; 6; 10; 3; 5; 4; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2037_2e5df993-6dce-4752-86be-1c73e5b8e5a1 48951-2037 HUMAN OTC DRUG Berberis e fruct. 10% Special Order Berberis e fruct. 10% Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK 1 [hp_X]/g 48951-2040_6f083a75-ce0f-4ce1-a2a1-bf868a4a24f2 48951-2040 HUMAN OTC DRUG Berberis e rad. 2 Special Order Berberis e rad. 2 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK 2 [hp_X]/mL 48951-2042_91a07e79-0508-4bde-b14e-ad6c4da51e02 48951-2042 HUMAN OTC DRUG Berberis Larix Berberis Larix LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACHILLEA MILLEFOLIUM; APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; EQUISETUM ARVENSE TOP; FERROUS DISULFIDE; LARIX DECIDUA RESIN; LYTTA VESICATORIA; SUS SCROFA URINARY BLADDER 3; 8; 3; 3; 8; 8; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2043_dcc33540-e05b-11de-8a39-0800200c9a66 48951-2043 HUMAN OTC DRUG Berberis Larix Urinary Tract Relief ACHILLEA MILLEFOLIUM BERBERIS VULGARIS ROOT BARK EQUISETUM ARVENSE TOP LYTTA VESICATORIA APIS MELLIFERA LARIX DECIDUA RESIN PELLET ORAL 20091201 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ACHILLEA MILLEFOLIUM; APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; EQUISETUM ARVENSE TOP; LARIX DECIDUA RESIN; LYTTA VESICATORIA 3; 8; 3; 3; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2044_7b5159e5-c893-42f1-ae26-4a7e82f80d7a 48951-2044 HUMAN OTC DRUG Berberis Oxalis Berberis Oxalis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; BOS TAURUS PROSTATE GLAND; MAGNESIUM SULFATE; OXALIS MONTANA LEAF; PENOXSULAM; SAW PALMETTO; URTICA URENS; VISCUM ALBUM FRUITING TOP 2; 8; 6; 3; 10; 3; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2045_1ec78f61-8a09-4e2c-9578-9d988fb480b5 48951-2045 HUMAN OTC DRUG Berberis Oxalis Berberis Oxalis PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; BOS TAURUS PROSTATE GLAND; MAGNESIUM SULFATE; OXALIS MONTANA LEAF; PENOXSULAM; SAW PALMETTO; URTICA URENS; VISCUM ALBUM FRUITING TOP 1; 8; 6; 3; 10; 3; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2046_df04437d-7bad-46d0-a11e-1768d6d2d900 48951-2046 HUMAN OTC DRUG Berberis Populus Adult Size Berberis Populus Adult Size SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; BLACK PEPPER; LARIX DECIDUA RESIN; POPULUS TREMULA WHOLE; SAW PALMETTO; URTICA URENS 3; 17; 8; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-2047_83b516de-d480-4f2d-98b3-ae85ab6a5070 48951-2047 HUMAN OTC DRUG Berberis Populus Berberis Populus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; BLACK PEPPER; LARIX DECIDUA RESIN; POPULUS TREMULA WHOLE; SAW PALMETTO; URTICA URENS 2; 17; 8; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2048_b0755b12-e446-4d58-9c5b-1f3f06cb9dcf 48951-2048 HUMAN OTC DRUG Berberis Populus Berberis Populus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; BLACK PEPPER; LARIX DECIDUA RESIN; POPULUS TREMULA WHOLE; SAW PALMETTO; URTICA URENS 1; 17; 8; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2049_299de309-c3d5-43c9-be4a-a4888c69f2a9 48951-2049 HUMAN OTC DRUG Berberis Prunus Berberis Prunus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT; BOS TAURUS NASAL MUCOSA; COLLOIDAL SILICON DIOXIDE; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; SILVER; SLOE 2; 6; 30; 2; 8; 8; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2050_1359fc92-92a0-4023-ad6b-e49a603abf45 48951-2050 HUMAN OTC DRUG Berberis Prunus Berberis Prunus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; BOS TAURUS NASAL MUCOSA; COLLOIDAL SILICON DIOXIDE; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; SILVER; SLOE 2; 8; 30; 2; 6; 8; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2051_c30929a4-4820-4017-b23d-443eb7ced61e 48951-2051 HUMAN OTC DRUG Berberis Prunus Nose Balm Berberis Prunus Nose Balm OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; LEMON; QUINCE; SLOE 1; 2; 2; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-2052_1983313a-200b-4137-8cd2-2ee850c38c12 48951-2052 HUMAN OTC DRUG Berberis Pyrite Special Order Berberis Pyrite Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; FERROUS DISULFIDE; MERCURIC SULFIDE; SAGE 3; 3; 8; 20; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2053_c9542669-99b3-440e-9726-5a5bfcaf7e0d 48951-2053 HUMAN OTC DRUG Berberis Pyrite Berberis Pyrite PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; FERROUS DISULFIDE; MERCURIC SULFIDE; SAGE 3; 3; 3; 20; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2054_3bfaccf2-204b-4dac-ad18-fc2224d5e000 48951-2054 HUMAN OTC DRUG Berberis Quartz Berberis Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; BOS TAURUS NASAL MUCOSA; COLLOIDAL SILICON DIOXIDE 3; 7; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2055_1496e424-2e05-4d4d-929a-230b67819678 48951-2055 HUMAN OTC DRUG BERBERIS QUARTZ BERBERIS QUARTZ PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC URIEL PHARMACY INC. BERBERIS VULGARIS ROOT BARK; BOS TAURUS NASAL MUCOSA; COLLOIDAL SILICON DIOXIDE 3; 7; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2056_d2972c79-fa8b-45b8-b2b7-d1ad52b0fbf3 48951-2056 HUMAN OTC DRUG Berberis Urtica Berberis Urtica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; URTICA URENS 2; 3 [hp_X]/mL; [hp_X]/mL 48951-2057_0dca16e9-0c8f-4a0a-b215-f1d43787c325 48951-2057 HUMAN OTC DRUG Berberis Urtica Berberis Urtica PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; URTICA URENS 1; 2 [hp_X]/1; [hp_X]/1 48951-2058_0270ab3d-7781-4d48-9391-bdc4ecf32805 48951-2058 HUMAN OTC DRUG Berberis Viscum Berberis Viscum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ALUMINUM OXIDE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS OVARY; BOS TAURUS UTERUS; MAGNESIUM SULFATE; OXALIS MONTANA LEAF; PENOXSULAM; URTICA URENS; VISCUM ALBUM FRUITING TOP 6; 2; 6; 6; 6; 3; 10; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2059_386d8c52-f466-4896-8991-c93a04bdf492 48951-2059 HUMAN OTC DRUG Berberis Viscum Berberis Viscum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ALUMINUM OXIDE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS OVARY; BOS TAURUS UTERUS; MAGNESIUM SULFATE; OXALIS MONTANA LEAF; PENOXSULAM; URTICA URENS; VISCUM ALBUM FRUITING TOP 6; 1; 6; 6; 6; 3; 10; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2062_c91ee672-431a-446c-9a41-5bb0b2f73904 48951-2062 HUMAN OTC DRUG Betonica Rosmarinus Betonica Rosmarinus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ROSMARINUS OFFICINALIS FLOWERING TOP; STACHYS OFFICINALIS 3; 3 [hp_X]/mL; [hp_X]/mL 48951-2063_0e76b233-74a1-4e10-a8b7-374b0f75687c 48951-2063 HUMAN OTC DRUG Betula Argentum Betula Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ARNICA MONTANA; BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; FORMICA RUFA; SILVER 3; 17; 3; 3; 7; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2064_ed42330f-f843-4148-9ae9-b0c89f567ec9 48951-2064 HUMAN OTC DRUG Betula Argentum Betula Argentum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ARNICA MONTANA; BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; FORMICA RUFA; SILVER 6; 17; 1; 1; 7; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2068_66760682-92f5-466a-94a9-db1cefed0a65 48951-2068 HUMAN OTC DRUG Betula Spiraea Betula spiraea LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; EQUISETUM ARVENSE TOP; FILIPENDULA ULMARIA ROOT; FORMICA RUFA; LEAD; MANDRAGORA OFFICINARUM ROOT 17; 3; 3; 17; 3; 10; 7; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2069_3109ba93-4432-44b5-a842-716c66580f77 48951-2069 HUMAN OTC DRUG Betula Spiraea Betula Spiraea PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; EQUISETUM ARVENSE TOP; FILIPENDULA ULMARIA ROOT; FORMICA RUFA; LEAD SULFIDE; MANDRAGORA OFFICINARUM ROOT 17; 3; 3; 17; 3; 10; 7; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2071_3fb529e0-0f4d-11df-8a39-0800200c9a66 48951-2071 HUMAN OTC DRUG Birch Juniper Rejuvenation BETULA PENDULA LEAF JUNIPERUS COMMUNIS FRUIT SYRUP ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc BETULA PENDULA LEAF; JUNIPERUS COMMUNIS FRUIT 1; 1 [hp_X]/1; [hp_X]/1 48951-2073_9b06aca5-7852-412d-b574-547a1f0b8829 48951-2073 HUMAN OTC DRUG Bismuth Stibium Wart Relief Bismuth Stibium Wart Relief OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; BISMUTH; CHELIDONIUM MAJUS; GARLIC; THUJA OCCIDENTALIS WHOLE; TURMERIC 2; 2; 1; 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-2075_0a3570e8-61cd-4afb-a847-3a02030cac02 48951-2075 HUMAN OTC DRUG Borago Lavender cum Cupro Borago Lavender cum Cupro LOTION TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BORAGE; CUPRIC SULFATE; HORSE CHESTNUT; MELILOTUS INDICUS WHOLE 20; 2; 20; 13 g/100g; [hp_X]/100g; g/100g; g/100g 48951-2076_0a6e511b-048d-4306-a460-d795a8b9872c 48951-2076 HUMAN OTC DRUG Borago Lavender Varicose Relief Borago Lavender Varicose Relief LOTION TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BORAGE; HORSE CHESTNUT; MELILOTUS INDICUS SEED 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-2077_5c1a247e-aee6-4a4a-95af-2a1e4c460ce1 48951-2077 HUMAN OTC DRUG Borago Nicotiana Borago Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ALUMINUM OXIDE; BORAGE; CENTAUREA BENEDICTA; FERROUS ARSENATE; HAMAMELIS VIRGINIANA LEAF; HORSE CHESTNUT; TOBACCO LEAF 8; 3; 3; 10; 3; 10; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2078_96d8cf96-fb8d-4b20-aedc-6fedbfc8131d 48951-2078 HUMAN OTC DRUG Borago Nicotiana Borago Nicotiana PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ALUMINUM OXIDE; BORAGO OFFICINALIS WHOLE; CENTAUREA BENEDICTA; FERROUS ARSENATE; HAMAMELIS VIRGINIANA LEAF; HORSE CHESTNUT; TOBACCO LEAF 8; 3; 3; 10; 3; 10; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2079_42ad8417-5384-4a0f-bee8-2dc82bd542c3 48951-2079 HUMAN OTC DRUG Breatheze Breatheze LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EUPHRASIA STRICTA; JUJUBE FRUIT; LONICERA DASYSTYLA FLOWER BUD; PAPRIKA; URTICA DIOICA LEAF; URTICA DIOICA ROOT 2; 2; 2; 2; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2080_4285d71e-98e2-4bc4-ad3c-d45b4dac8366 48951-2080 HUMAN OTC DRUG Bronchi 17 Special Order Bronchi 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF LUNG 17 [hp_X]/mL 48951-2082_1e7d6a70-9c88-4156-bdc9-7676a0bbf805 48951-2082 HUMAN OTC DRUG Bryonia Apis Special Order Bryonia Apis Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA; BOS TAURUS OVARY; BRYONIA ALBA ROOT; PULSATILLA VULGARIS; SUS SCROFA FALLOPIAN TUBE 8; 6; 20; 6; 6; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2083_b0da8ee5-d79c-4045-9541-16a930fc4482 48951-2083 HUMAN OTC DRUG Bryonia Apis Special Order Bryonia Apis Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA; BOS TAURUS OVARY; BRYONIA ALBA ROOT; PULSATILLA VULGARIS; SUS SCROFA FALLOPIAN TUBE 8; 6; 20; 6; 6; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2084_12742f30-e03b-11de-8a39-0800200c9a66 48951-2084 HUMAN OTC DRUG Bryonia Eucalyptus Flu Relief ACONITUM NAPELLUS ROOT BRYONIA CRETICA SUBSP. DIOICA ROOT EUPATORIUM CANNABINUM WHOLE FLOWERING CINCHONA OFFICINALIS BARK EUCALYPTUS GLOBULUS LEAF PELLET ORAL 20091201 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ACONITUM NAPELLUS ROOT; BRYONIA CRETICA SUBSP. DIOICA ROOT; CINCHONA OFFICINALIS BARK; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM CANNABINUM WHOLE FLOWERING 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2085_7c0cb52e-a896-4232-979e-259be12619b8 48951-2085 HUMAN OTC DRUG Bryonia Spongia Bryonia Spongia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; SPONGIA OFFICINALIS WHOLE 4; 4; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2086_8f75d9d4-f7e9-4c92-b3ea-f3ca0b89286e 48951-2086 HUMAN OTC DRUG Bryonia Stannum Bryonia Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BRYONIA ALBA ROOT; TIN 3; 17 [hp_X]/mL; [hp_X]/mL 48951-2087_5fccd812-76cc-499f-ac4c-b6ca924f752d 48951-2087 HUMAN OTC DRUG Bryonia Stannum Bryonia Stannum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BRYONIA ALBA ROOT; TIN 3; 17 [hp_X]/1; [hp_X]/1 48951-2088_47afac1e-c752-4c70-857a-83db2c0952e7 48951-2088 HUMAN OTC DRUG Bryophyllum Argentum Bryophyllum Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS UTERUS; KALANCHOE DAIGREMONTIANA LEAF; SILVER 8; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2089_10cc9155-1483-4208-88be-1286080811e2 48951-2089 HUMAN OTC DRUG Bryophyllum Argentum Bryophyllum Argentum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS UTERUS; KALANCHOE DAIGREMONTIANA LEAF; SILVER 8; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2090_cbdd29d6-d0bb-4f7c-b6c3-074b779f3463 48951-2090 HUMAN OTC DRUG Bryophyllum Avena Bryophyllum Avena LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AVENA SATIVA FLOWERING TOP; KALANCHOE DAIGREMONTIANA LEAF; OSTREA EDULIS SHELL; PHOSPHORUS; SULFUR; VALERIAN 6; 3; 7; 30; 30; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2091_5c17bd20-06ae-11df-8a39-0800200c9a66 48951-2091 HUMAN OTC DRUG Bryophyllum Avena Tension Relief OAT VALERIAN ROOT OYSTER SHELL CALCIUM CARBONATE, CRUDE PHOSPHORUS SULFUR LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc OAT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SULFUR; VALERIAN ROOT 3; 7; 30; 30; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2092_09ddb1ca-6404-4abb-b3f0-948df1cdbc2f 48951-2092 HUMAN OTC DRUG Bryophyllum Conchae Bryophyllum Conchae PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; OSTREA EDULIS SHELL 5; 7 [hp_X]/1; [hp_X]/1 48951-2094_040b6c18-1a0e-4c08-b9fb-dcd26b753f8a 48951-2094 HUMAN OTC DRUG Bryophyllum e fol. 10 Bryophyllum e fol. 10 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF 1 [hp_X]/mL 48951-2095_97869a54-17e3-4c93-af55-be9d28be5d83 48951-2095 HUMAN OTC DRUG Bryophyllum e fol. 10 Bryophyllum e fol. 10 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF 1 [hp_X]/1 48951-2096_338f2bf7-6f1f-47dd-8435-a99cb83206ab 48951-2096 HUMAN OTC DRUG Bryophyllum e fol. 3 Special Order Bryophyllum e fol. 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF 3 [hp_X]/mL 48951-2099_f2b1c808-07de-4fad-9215-0bc0436d9e17 48951-2099 HUMAN OTC DRUG Bryophyllum e fol. 5% Bryophyllum e fol. 5% LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF 1 [hp_X]/mL 48951-2102_f1609f27-4611-453b-be86-d406c94b9ac2 48951-2102 HUMAN OTC DRUG Citrus Cydonia 1 Citrus Cydonia 1 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON; QUINCE 1; 1 [hp_X]/mL; [hp_X]/mL 48951-2104_6521d57c-a690-4e7f-8099-cd1d70409f77 48951-2104 HUMAN OTC DRUG Barium Conchae Mercurius Special Order Barium Conchae Mercurius Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BARIUM CITRATE; BARIUM IODATE; BERBERIS VULGARIS ROOT BARK; FERROUS ARSENATE; MERCURIC SULFIDE; MERCURY; OSTREA EDULIS SHELL 8; 4; 4; 6; 6; 14; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-2105_1d6d839e-4636-48b6-afa3-a530e368e560 48951-2105 HUMAN OTC DRUG Bryophyllum Conchae Special Order Bryophyllum Conchae Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; OSTREA EDULIS SHELL 5; 7 [hp_X]/mL; [hp_X]/mL 48951-2106_c121d46a-a455-4ed7-8116-3153e20ed108 48951-2106 HUMAN OTC DRUG Belladonna ex herba 3 Special Order Belladonna ex herba 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA 3 [hp_X]/mL 48951-2108_a0e22454-5ba9-47f1-8003-8ffd8e9ae0ef 48951-2108 HUMAN OTC DRUG Bambusa Viscum Stannum Special Order Bambusa Viscum Stannum Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; COLLOIDAL SILICON DIOXIDE; EQUISETUM ARVENSE TOP; FORMICA RUFA; ROSMARINUS OFFICINALIS FLOWERING TOP; STACHYS OFFICINALIS; TIN; VISCUM ALBUM FRUITING TOP 6; 6; 12; 15; 5; 6; 6; 7; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-2109_e3cc2d2f-2324-4932-84c6-267c22215e30 48951-2109 HUMAN OTC DRUG Bambusa Nicotiana Special Order Bambusa Nicotiana Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; BOS TAURUS PITUITARY GLAND; COLLOIDAL SILICON DIOXIDE; EQUISETUM ARVENSE TOP; FORMICA RUFA; ROSMARINUS OFFICINALIS FLOWERING TOP; STACHYS OFFICINALIS; TIN; TOBACCO LEAF 6; 8; 8; 12; 15; 7; 6; 6; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-2110_27a09a7c-eac3-4787-97f5-183d4d50d5df 48951-2110 HUMAN OTC DRUG Bryonia Stannum Special Order Bryonia Stannum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BRYONIA ALBA ROOT; TIN 3; 17 [hp_X]/mL; [hp_X]/mL 48951-2111_7416822b-62ea-4d8c-a1d2-2db65470812b 48951-2111 HUMAN OTC DRUG Berberis Oxalis Special Order Berberis Oxalis Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; BOS TAURUS PROSTATE GLAND; MAGNESIUM SULFATE; OXALIS MONTANA LEAF; PENOXSULAM; SAW PALMETTO; URTICA URENS; VISCUM ALBUM FRUITING TOP 2; 8; 6; 3; 10; 3; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-2112_14003b41-75cc-4a1d-8cbd-0fdc22238586 48951-2112 HUMAN OTC DRUG Betula e cort. 2 Special Order Betula e cort. 2 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS BARK 2 [hp_X]/mL 48951-3001_584efa8b-243f-4307-9cc5-dfc7ed118121 48951-3001 HUMAN OTC DRUG Cactus Cinis Avenae Cactus Cinis Avenae PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; HAWTHORN LEAF WITH FLOWER; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; SELENICEREUS GRANDIFLORUS STEM 20; 3; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3002_f656a627-99c8-468b-bd39-9aafb3499038 48951-3002 HUMAN OTC DRUG Cactus Cinis Avenae Special Order Cactus Cinis Avenae Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; HAWTHORN LEAF WITH FLOWER; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; SELENICEREUS GRANDIFLORUS STEM 20; 3; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3003_1441ab96-24e4-41f3-9555-41b2d77bde5f 48951-3003 HUMAN OTC DRUG Cactus Crataegus Special Order Cactus Crataegus Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAWTHORN LEAF WITH FLOWER; MELISSA OFFICINALIS; SELENICEREUS GRANDIFLORUS STEM 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3004_39ca7c88-5b2d-4932-9b66-ee3898302b88 48951-3004 HUMAN OTC DRUG Cactus Crataegus Cactus Crataegus CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; ARNICA MONTANA; GOLD; HAWTHORN LEAF WITH FLOWER; LATRODECTUS MACTANS; NITROGLYCERIN; SELENICEREUS GRANDIFLORUS STEM; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 13; 13; 9; 9; 2; 16; 5; 3; 13; 11 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-3005_86f817e1-9760-44bf-a2a2-933d845920c6 48951-3005 HUMAN OTC DRUG Cactus Crataegus Cactus Crataegus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAWTHORN LEAF WITH FLOWER; MELISSA OFFICINALIS; SELENICEREUS GRANDIFLORUS STEM 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3006_30d9eca8-5861-422d-a702-5a83f3b003bb 48951-3006 HUMAN OTC DRUG Calcium carb. Cortex Quercus 30 Special Order Calcium carb. Cortex Quercus 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CARBONATE ION; QUERCUS ROBUR WHOLE 30; 30 [hp_X]/mL; [hp_X]/mL 48951-3007_b93104b0-a851-4877-aa16-3ad7175d76bc 48951-3007 HUMAN OTC DRUG Calcium carbonicum 3 Special Order Calcium carbonicum 3 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CARBONATE ION 3 [hp_X]/g 48951-3008_67d058c9-bbc1-4249-b115-3d5b0688898c 48951-3008 HUMAN OTC DRUG Calcium Carbonicum 30 Special Order Calcium Carbonicum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CARBONATE ION 30 [hp_X]/mL 48951-3009_b1f93276-a3e9-4781-87ba-27431f694517 48951-3009 HUMAN OTC DRUG Calendula 10 Calendula 10 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g 48951-3010_64d67f68-0b2c-4ef4-b4d9-900bb8e5e8b4 48951-3010 HUMAN OTC DRUG Calendula Healing Calendula Healing GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g 48951-3011_bd19aba7-71ce-4481-a533-136f24979f6e 48951-3011 HUMAN OTC DRUG Calendula ex herba 3 Special Order Calendula ex herba 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X]/mL 48951-3013_b942e82a-6891-4677-bd52-e2f3d98aef1b 48951-3013 HUMAN OTC DRUG Calendula ex herba 6 Special Order Calendula ex herba 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP 6 [hp_X]/mL 48951-3014_71c048e9-f0de-45e3-bfe0-0c8ef26fdbc0 48951-3014 HUMAN OTC DRUG Calendula Healing Calendula Healing LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/mL 48951-3015_a551d339-05cc-4cdb-bcf3-2ac924b806fc 48951-3015 HUMAN OTC DRUG Calendula Stibium Calendula Stibium CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; CALENDULA OFFICINALIS FLOWERING TOP 3; 2 [hp_X]/g; [hp_X]/g 48951-3016_db86c163-df48-48f5-b48e-3e10e7a56f87 48951-3016 HUMAN OTC DRUG Calendula Thuja Flora Calendula Thuja Flora GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP; CANDIDA ALBICANS; ECHINACEA, UNSPECIFIED; LILIUM LANCIFOLIUM WHOLE FLOWERING; ORIGANUM MAJORANA WHOLE; PULSATILLA VULGARIS; SILVER; THUJA OCCIDENTALIS WHOLE; WOOD CREOSOTE 2; 33; 2; 3; 2; 6; 7; 3; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-3018_5900725d-7539-4b9f-9d8c-02d9bd710be5 48951-3018 HUMAN OTC DRUG Capsicum Chamomilla Special Order Capsicum Chamomilla Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERROSOFERRIC PHOSPHATE; LEVISTICUM OFFICINALE ROOT; MATRICARIA RECUTITA; MERCURIC IODIDE; PAPRIKA; PULSATILLA VULGARIS 12; 2; 3; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3019_c32e6e99-1f2a-4fce-9540-04658ba636af 48951-3019 HUMAN OTC DRUG Capsicum Chamomilla Capsicum Chamomilla PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERROSOFERRIC PHOSPHATE; LEVISTICUM OFFICINALE ROOT; MATRICARIA RECUTITA; MERCURIC IODIDE; PAPRIKA; PULSATILLA VULGARIS 12; 2; 3; 12; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3020_200bff68-bc6c-433a-a045-40345548b714 48951-3020 HUMAN OTC DRUG Carbo Betulae 20 Special Order Carbo Betulae 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL 20 [hp_X]/mL 48951-3021_9d33bd5a-d109-473c-b74d-130bed591670 48951-3021 HUMAN OTC DRUG Carbo Betulae 30 Special Order Carbo Betulae 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL 30 [hp_X]/mL 48951-3024_7282ff90-32a3-11df-9aae-0800200c9a66 48951-3024 HUMAN OTC DRUG Carbo Chamomilla Digestive Support ACTIVATED CHARCOAL ARTEMISIA ABSINTHIUM FLOWERING TOP MATRICARIA RECUTITA GENTIANA LUTEA ROOT AVENS EXTRACT BLACK PEPPER GINGER ANTIMONY TRISULFIDE ARSENIC TRIOXIDE POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ARTEMISIA ABSINTHIUM FLOWERING TOP; AVENS EXTRACT; BLACK PEPPER; GENTIANA LUTEA ROOT; GINGER; MATRICARIA RECUTITA 2; 3; 6; 3; 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3027_a3a714f1-9cef-4759-99a2-72a89506d96c 48951-3027 HUMAN OTC DRUG Carduus Marianus e fruct. 30 Carduus Marianus e fruct. 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MILK THISTLE 1 [hp_X]/mL 48951-3028_c33b6579-06f4-4104-8c0a-b742fea98430 48951-3028 HUMAN OTC DRUG Carduus marianus e fruct. 6 Special Order Carduus marianus e fruct. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MILK THISTLE 6 [hp_X]/mL 48951-3029_edafb4be-45d2-4bf2-a073-a3eef3f71d97 48951-3029 HUMAN OTC DRUG Carduus Oxalis Special Order Carduus Oxalis Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MILK THISTLE; OXALIS MONTANA LEAF 2; 3 [hp_X]/mL; [hp_X]/mL 48951-3030_4c89c2aa-3e54-4eb1-b385-9beee6192569 48951-3030 HUMAN OTC DRUG Carduus Oxalis Carduus Oxalis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MILK THISTLE; OXALIS MONTANA LEAF 1; 3 [hp_X]/mL; [hp_X]/mL 48951-3031_f7f3a0c7-2ef4-4eb4-8cef-f06ffab2f479 48951-3031 HUMAN OTC DRUG Carduus Oxalis Special Order Carduus Oxalis Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MILK THISTLE; OXALIS MONTANA LEAF 3; 3 [hp_X]/1; [hp_X]/1 48951-3032_7bbea450-543a-4b1c-8746-29b678ecd2bc 48951-3032 HUMAN OTC DRUG Carduus Viscum Carduus Viscum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; MILK THISTLE; VISCUM ALBUM FRUITING TOP 8; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3033_c3f696b6-3082-4806-9f03-f29d1d56f24b 48951-3033 HUMAN OTC DRUG Carduus Viscum Special Order Carduus Viscum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; MILK THISTLE; VISCUM ALBUM FRUITING TOP 8; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3034_fcb68647-03e3-4d3b-b011-d9f0f72c78e0 48951-3034 HUMAN OTC DRUG Carpellum Mali Comp. Carpellum Mali Comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ENGLISH WALNUT; MALUS DOMESTICA WHOLE 4; 4 [hp_X]/mL; [hp_X]/mL 48951-3035_aa93c9b5-f25e-4ef6-8e33-9d0cb3b6350c 48951-3035 HUMAN OTC DRUG Cartilago Argentum Cartilago Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARNICA MONTANA; BETULA PUBESCENS LEAF; BOS TAURUS CARTILAGE; MANDRAGORA OFFICINARUM ROOT; SILVER 6; 6; 6; 6; 6; 5; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3036_1f8da0d9-b5e0-493e-b212-580df96199df 48951-3036 HUMAN OTC DRUG Cartilago Argentum Joint Support Cartilago Argentum Joint Support CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARNICA MONTANA; BETULA PUBESCENS LEAF; BOS TAURUS CARTILAGE; MANDRAGORA OFFICINARUM ROOT; SILVER 6; 5; 6; 3; 6; 3; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-3037_36181840-f632-11de-8a39-0800200c9a66 48951-3037 HUMAN OTC DRUG Cartilago Argentum Joint Support MANDRAGORA OFFICINARUM ROOT BETULA PENDULA LEAF ACONITUM NAPELLUS ROOT ARNICA MONTANA SILVER PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ACONITUM NAPELLUS ROOT; ARNICA MONTANA; BETULA PENDULA LEAF; MANDRAGORA OFFICINARUM ROOT; SILVER 6; 6; 5; 5; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3039_b4e3eb0f-9b82-4907-94f8-677f3822388a 48951-3039 HUMAN OTC DRUG Cartilago Betula Cartilago Betula LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BETULA PUBESCENS LEAF; BOS TAURUS CARTILAGE; FORMICA RUFA; GOLD; ONION; TIN 6; 6; 5; 8; 17; 10; 17; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3040_6fe52be3-1913-4f5b-8657-47c84e0ca373 48951-3040 HUMAN OTC DRUG Cartilago Betula Cartilago Betula CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BETULA PUBESCENS LEAF; BOS TAURUS CARTILAGE; FORMICA RUFA; GOLD; ONION; TIN 6; 6; 3; 6; 7; 10; 3; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-3041_3a66278f-02db-452d-9b3d-73c971356070 48951-3041 HUMAN OTC DRUG Cartilago Betula Cartilago Betula PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BETULA PUBESCENS LEAF; BOS TAURUS CARTILAGE; FORMICA RUFA; GOLD; ONION; TIN 6; 6; 5; 8; 17; 10; 17; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3042_f025b01d-327f-4fe8-98a2-d1b33a937cf9 48951-3042 HUMAN OTC DRUG Cartilago Quartz Cartilago Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF; COLLOIDAL SILICON DIOXIDE; ECHINACEA ANGUSTIFOLIA 30; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3043_e5a545fb-bbbc-43dd-9c29-71ab663976c6 48951-3043 HUMAN OTC DRUG Cartilago Quartz Cartilago Quartz CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF; COLLOIDAL SILICON DIOXIDE; ECHINACEA, UNSPECIFIED 30; 30; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-3044_00da9de2-1d09-4359-a09f-1f1682f03941 48951-3044 HUMAN OTC DRUG Cartilago Quartz Cartilago Quartz PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF; COLLOIDAL SILICON DIOXIDE; ECHINACEA ANGUSTIFOLIA 30; 30; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3046_b703cbb7-8362-43ae-b60c-427b74e07936 48951-3046 HUMAN OTC DRUG Celandine Honey Celandine Honey LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS; HONEY 4; 4 [hp_X]/mL; [hp_X]/mL 48951-3047_6dfd5061-4710-43bb-bab8-7f06f078bc97 48951-3047 HUMAN OTC DRUG Cerebellum 4 Special Order Cerebellum 4 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS CEREBELLUM 4 [hp_X]/mL 48951-3048_ef7a027e-f277-4a9e-8439-de516aa59186 48951-3048 HUMAN OTC DRUG Cerebellum Thalamus A Cerebellum Thalamus A LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BRAIN; BOS TAURUS CEREBELLUM; BOS TAURUS EYE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; COLLOIDAL SILICON DIOXIDE; SUS SCROFA THALAMUS 8; 8; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3049_a27273db-56d3-44c9-9f40-c6b042145d5a 48951-3049 HUMAN OTC DRUG Cerebellum Thalamus A Cerebellum Thalamus A PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BRAIN; BOS TAURUS CEREBELLUM; BOS TAURUS EYE; BOS TAURUS PITUITARY GLAND; COLLOIDAL SILICON DIOXIDE; SUS SCROFA THALAMUS 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3050_94a28d4f-f8a3-4001-83ad-c2866ed183b3 48951-3050 HUMAN OTC DRUG Cerebellum Thalamus A Aurm Cerebellum Thalamus A Aurum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BRAIN; BOS TAURUS CEREBELLUM; BOS TAURUS EYE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; COLLOIDAL SILICON DIOXIDE; FRANKINCENSE; GOLD; MYRRH; SUS SCROFA THALAMUS 8; 8; 8; 8; 8; 8; 7; 10; 7; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3051_f01e3ba7-d12d-4cba-af1d-ed558aac9c75 48951-3051 HUMAN OTC DRUG Cerebellum Thalamus A Aurum Cerebellum Thalamus A Aurum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BRAIN; BOS TAURUS CEREBELLUM; BOS TAURUS EYE; BOS TAURUS PITUITARY GLAND; COLLOIDAL SILICON DIOXIDE; FRANKINCENSE; GOLD; MYRRH; SUS SCROFA THALAMUS 8; 8; 8; 8; 8; 7; 10; 7; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3052_60f993cd-8587-4b94-bc09-61a5ac3d510e 48951-3052 HUMAN OTC DRUG Cerebellum Thalamus B Cerebellum Thalamus B LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BIFENTHRIN; BOS TAURUS BRAIN; BOS TAURUS CEREBELLUM; BOS TAURUS NERVE; BOS TAURUS PINEAL GLAND; SUS SCROFA EAR; SUS SCROFA THALAMUS 8; 8; 8; 8; 8; 17; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3053_efbd8a5e-2793-4ef3-b577-832e8c94326b 48951-3053 HUMAN OTC DRUG Cerebellum Thalamus B Cerebellum Thalamus B PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BIFENTHRIN; BOS TAURUS BONE; BOS TAURUS BRAIN; BOS TAURUS NERVE; SUS SCROFA EAR; SUS SCROFA THALAMUS; VISCUM ALBUM FRUITING TOP 8; 8; 8; 8; 17; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3054_35ea5d1c-3937-412b-a742-bcad48f46953 48951-3054 HUMAN OTC DRUG Cerebellum Thalamus B Aurum Cerebellum Thalamus B Aurum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BIFENTHRIN; BOS TAURUS BRAIN; BOS TAURUS CEREBELLUM; BOS TAURUS NERVE; BOS TAURUS PINEAL GLAND; FRANKINCENSE; GOLD; MYRRH; SUS SCROFA EAR; SUS SCROFA THALAMUS 8; 8; 8; 8; 8; 7; 10; 7; 17; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3055_67387afd-dcaf-4172-a6b9-3888359fa1c8 48951-3055 HUMAN OTC DRUG Cerebellum Thalamus B Aurum Cerebellum Thalamus B Aurum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BIFENTHRIN; BOS TAURUS BRAIN; BOS TAURUS CEREBELLUM; BOS TAURUS NERVE; BOS TAURUS PINEAL GLAND; FRANKINCENSE; GOLD; MYRRH; SUS SCROFA EAR; SUS SCROFA THALAMUS 8; 8; 8; 8; 8; 7; 10; 7; 12; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3056_a8197683-8f31-4e72-9709-db437e99713c 48951-3056 HUMAN OTC DRUG Cerussite 8 Cerussite 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEAD CARBONATE 8 [hp_X]/mL 48951-3059_c4ea84b8-85a9-48ed-9bae-736486465b20 48951-3059 HUMAN OTC DRUG Chamomilla 10 Special Order Chamomilla 10 Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA 1 [hp_X]/g 48951-3060_c6d5c928-d954-4dfb-849b-fdf5e5ca27a9 48951-3060 HUMAN OTC DRUG Chamomilla Belladonna Adult Size Chamomilla Belladonna Adult Size SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; MATRICARIA RECUTITA; SILVER 4; 3; 3; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-3061_50a80ab6-08a7-4332-bbda-828feeef600d 48951-3061 HUMAN OTC DRUG Chamomilla Belladonna Special Order Chamomilla Belladonna Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; MATRICARIA RECUTITA; TOBACCO LEAF 6; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3062_e8313580-decb-11de-8a39-0800200c9a66 48951-3062 HUMAN OTC DRUG Chamomila Cramp Relief MATRICARIA RECUTITA ATROPA BELLADONNA ROOT TOBACCO LEAF PELLET ORAL 20091201 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ATROPA BELLADONNA ROOT; MATRICARIA RECUTITA; TOBACCO LEAF 6; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3064_8deb41c0-6477-49d7-82a1-037d0aa68758 48951-3064 HUMAN OTC DRUG Chamomilla Cupro 3 Special Order Chamomilla Cupro 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER; MATRICARIA RECUTITA 3; 3 [hp_X]/mL; [hp_X]/mL 48951-3065_7d891593-9b28-4dba-be1d-497a94302a6f 48951-3065 HUMAN OTC DRUG Chamomilla e pl. tota 15 Special Order Chamomilla e pl. tota 15 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA 15 [hp_X]/mL 48951-3066_3ad79ad7-9eed-4e34-aa79-c994bd20ae7c 48951-3066 HUMAN OTC DRUG Chamomilla e pl. tota 3 Special Order Chamomilla e pl. tota 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA 3 [hp_X]/mL 48951-3067_527716a4-2826-4de0-8e22-b8c082cdfd41 48951-3067 HUMAN OTC DRUG Chamomilla e pl. tota 30 Special Order Chamomilla e pl. tota 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA 30 [hp_X]/mL 48951-3068_0c907829-07c0-4f2b-949e-588a15addaf7 48951-3068 HUMAN OTC DRUG Chamomilla e pl. tota 30 Special Order Chamomilla e pl. tota 30 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA 30 [hp_X]/1 48951-3070_397c735e-c980-4c4c-bebf-8e2f9ead6f57 48951-3070 HUMAN OTC DRUG Chamomilla e rad. 20 Special Order Chamomilla e rad. 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA 20 [hp_X]/mL 48951-3072_e40ef8f8-0322-40a2-ba3e-a02fbb311ff7 48951-3072 HUMAN OTC DRUG Chamomilla e rad. 6 Special Order Chamomilla e rad. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA 6 [hp_X]/mL 48951-3073_7ed6c385-d556-4b79-9716-2ae19ca104ac 48951-3073 HUMAN OTC DRUG Chelidonium Cichorium Chelidonium Cichorium CAPSULE, LIQUID FILLED ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS GALLBLADDER; CHELIDONIUM MAJUS; CHICORY ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; IRON 6; 4; 4; 4; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3076_cd17c4ec-8ce7-41cf-99bc-a9ad8f7720d7 48951-3076 HUMAN OTC DRUG Chelidonium Curcuma Chelidonium Curcuma LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS ROOT; TURMERIC 1; 1 [hp_X]/mL; [hp_X]/mL 48951-3077_bb4ba75b-ad72-4631-a4c1-dda21717842b 48951-3077 HUMAN OTC DRUG Chelidonium Curcuma Chelidonium Curcuma PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS ROOT; TURMERIC 3; 3 [hp_X]/1; [hp_X]/1 48951-3078_4dc4783f-5661-4efe-9e17-63239c49853d 48951-3078 HUMAN OTC DRUG Chelidonium Curcuma Thuja Chelidonium Curcuma Thuja LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS ROOT; THUJA OCCIDENTALIS WHOLE; TURMERIC 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3079_da54198e-f5c3-4c24-a9e4-02985b370516 48951-3079 HUMAN OTC DRUG Chelidonium Ferro 3 Chelidonium Ferro 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS ROOT 3 [hp_X]/mL 48951-3080_1b153269-8602-4457-b402-4a12dad081b2 48951-3080 HUMAN OTC DRUG Chelidonium Rosa Chelidonium Rosa LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS ROOT; COLLOIDAL SILICON DIOXIDE; FERRIC OXIDE RED; LARIX DECIDUA RESIN; RUTA GRAVEOLENS FLOWERING TOP; SEDUM ROSEUM WHOLE 4; 6; 3; 6; 4; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3081_65970c54-952f-402c-b9cd-02fc85ece0da 48951-3081 HUMAN OTC DRUG Chelidonium Spongia Special Order Chelidonium Spongia Special Order OINTMENT ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE WHOLE; SPONGIA OFFICINALIS WHOLE 2; 2; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-3082_ad351a78-403d-4fc5-b5d6-2f718ccc4b67 48951-3082 HUMAN OTC DRUG Chestnut Beeswax Chestnut Beeswax OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BRYONIA ALBA ROOT; EQUISETUM ARVENSE TOP; FORMICA RUFA; HORSE CHESTNUT 3; 2; 5; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-3083_0532f490-2150-11df-8a39-0800200c9a66 48951-3083 HUMAN OTC DRUG Chicory Ginger Digestive Bitters SILYBUM MARIANUM SEED GENTIANA LUTEA ROOT ARTEMISIA VULGARIS ROOT GINGER CHELIDONIUM MAJUS BLACK PEPPER LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ARTEMISIA VULGARIS ROOT; BLACK PEPPER; CHELIDONIUM MAJUS; GENTIANA LUTEA ROOT; GINGER; SILYBUM MARIANUM SEED 1; 3; 3; 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3085_aa4fdae4-e107-4cf6-815d-2b54245224a4 48951-3085 HUMAN OTC DRUG Chrysolith 6 Chrysolith 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 6 [hp_X]/mL 48951-3086_c682ee6c-6b5c-495f-8823-920c0a6479c3 48951-3086 HUMAN OTC DRUG Chrysolith Retina Chrysolith Retina LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS EYE; COLLOIDAL SILICON DIOXIDE; LARIX DECIDUA RESIN 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3087_4e913311-f71c-4cc6-962c-2199a682741a 48951-3087 HUMAN OTC DRUG Chrysolith Retina Chrysolith Retina PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS EYE; COLLOIDAL SILICON DIOXIDE; LARIX DECIDUA RESIN 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3088_26b89728-1362-47c0-89f8-207196319e6c 48951-3088 HUMAN OTC DRUG Chrysosplenium Chamomilla Chrysosplenium Chamomilla LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHRYSOSPLENETIN; CICHORIUM INTYBUS WHOLE; MATRICARIA RECUTITA; TARAXACUM PALUSTRE ROOT 3; 6; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3089_5698d277-d245-48f2-9c94-2cef6602d2e5 48951-3089 HUMAN OTC DRUG Chrysosplenium Chamomilla Chrysosplenium Chamomilla PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHRYSOSPLENETIN; CICHORIUM INTYBUS WHOLE; MATRICARIA RECUTITA; TARAXACUM PALUSTRE ROOT 3; 6; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3091_c6f7768d-4e70-478b-a873-78f7301df50e 48951-3091 HUMAN OTC DRUG Cichorium Oxalis Cichorium Oxalis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL; BARIUM CITRATE; CICHORIUM INTYBUS WHOLE; IRON; OXALIS MONTANA LEAF; SUS SCROFA PANCREAS 6; 10; 3; 20; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3092_b52627b3-71ba-4638-85cd-80ea93e9f0dd 48951-3092 HUMAN OTC DRUG Cichorium Oxalis Special Order Cichorium Oxalis Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL; BARIUM CITRATE; CICHORIUM INTYBUS WHOLE; IRON; OXALIS MONTANA LEAF; SUS SCROFA PANCREAS 6; 10; 3; 20; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3093_fd9635d0-bd9b-4b5d-8784-1eeaf4b35ac7 48951-3093 HUMAN OTC DRUG Cichorium Stibium Special Order Cichorium Stibium Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; CICHORIUM INTYBUS WHOLE; SUS SCROFA PANCREAS; TOBACCO LEAF 6; 4; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3094_3c2fd176-b9fa-4304-895a-b297c167dad3 48951-3094 HUMAN OTC DRUG Cichorium Stibium Cichorium Stibium PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; CICHORIUM INTYBUS WHOLE; SUS SCROFA PANCREAS; TOBACCO LEAF 6; 4; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3095_7a80ceb2-da04-42a6-8cee-cb095416a044 48951-3095 HUMAN OTC DRUG Chamomilla Belladonna Child Size Special Order Chamomilla Belladonna Child Size Special Order SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; CHAMOMILE; ECHINACEA ANGUSTIFOLIA; SILVER 4; 3; 3; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-3096_6f3d0b8c-e6b6-4b9b-b3e6-c32cfa0a59ab 48951-3096 HUMAN OTC DRUG Caraway Oil 1 Special Order Caraway Oil 1 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CARAWAY OIL 2 [hp_X]/g 48951-3097_4f7961ad-2492-4c61-8614-70c17dc7dff1 48951-3097 HUMAN OTC DRUG Cinis Quercus 3 Special Order Cinis Quercus 3 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. QUERCUS ROBUR WHOLE 3 [hp_X]/g 48951-3100_bbc3bdf9-3b4a-4b64-bce4-09fe7a1995c9 48951-3100 HUMAN OTC DRUG Cinnabar comp. Cinnabar comp. PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA VENOM; ATROPA BELLADONNA; MERCURIC SULFIDE 6; 6; 7 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3101_e5ba22ac-8c98-4575-b357-0a1f935afd00 48951-3101 HUMAN OTC DRUG Cinnabar Dandelion Cinnabar Dandelion LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CARBONATE ION; ELYMUS REPENS ROOT; FERROUS DISULFIDE; MERCURIC CATION; TARAXACUM PALUSTRE ROOT 10; 3; 8; 20; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3102_a8f9adb0-f62d-11de-8a39-0800200c9a66 48951-3102 HUMAN OTC DRUG Cinnabar Dandelion Cold Relief TARAXACUM OFFICINALE ELYMUS REPENS ROOT POTASH MERCURIC SULFIDE PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ELYMUS REPENS ROOT; MERCURIC SULFIDE; POTASH; TARAXACUM OFFICINALE 3; 20; 10; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3103_946d5cd9-3462-420a-97d1-74ed52f890c7 48951-3103 HUMAN OTC DRUG Citrus Cydonia 3 Citrus Cydonia 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON; QUINCE 1; 1 [hp_X]/mL; [hp_X]/mL 48951-3104_1f11da2d-befb-482f-82bc-c4080f7f5bf5 48951-3104 HUMAN OTC DRUG Citrus Cydonia 5% CITRUS CYDONIA 5% LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON; QUINCE 1; 1 [hp_X]/mL; [hp_X]/mL 48951-3106_26fb1bd6-8f8e-4028-999d-91261b176ded 48951-3106 HUMAN OTC DRUG Citrus Cydonia 7 Citrus Cydonia 7 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON; QUINCE 1; 1 [hp_X]/mL; [hp_X]/mL 48951-3107_436321f2-1f42-408e-bffe-e988ce4bb3b1 48951-3107 HUMAN OTC DRUG Citrus Quartz Citrus Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AGROPYRON FRAGILE WHOLE; COLLOIDAL SILICON DIOXIDE; LARIX DECIDUA RESIN; LEMON; QUINCE; SAMBUCUS CANADENSIS FLOWER; TILIA AMERICANA FLOWER 5; 20; 10; 2; 2; 5; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3108_9899d8f0-b3e0-4565-8fca-5f872f307382 48951-3108 HUMAN OTC DRUG Cocculus Conium Special Order Cocculus Conium Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMBERGRIS; ANAMIRTA COCCULUS WHOLE; CONIUM MACULATUM ROOT; LIQUID PETROLEUM 7; 4; 4; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3109_5d228d3c-0b81-42e4-bc97-a3acb0da7302 48951-3109 HUMAN OTC DRUG Cocculus Conium Cocculus Conium PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMBERGRIS; ANAMIRTA COCCULUS WHOLE; CONIUM MACULATUM ROOT; LIQUID PETROLEUM 7; 4; 4; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3110_a0a6a0e5-0c1e-42f6-91ff-408040b62609 48951-3110 HUMAN OTC DRUG Cochlea 8 Special Order Cochlea 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BONE 8 [hp_X]/mL 48951-3112_cc49893e-4953-4b30-b435-276924db71f1 48951-3112 HUMAN OTC DRUG Colchicum Chelidonium Colchicum Chelidonium LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE WHOLE 3; 3 [hp_X]/mL; [hp_X]/mL 48951-3113_11fd6465-657d-4234-9ea3-8c85e9e3614c 48951-3113 HUMAN OTC DRUG Colchicum Chelidonium Special Order Colchicum Chelidonium Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE WHOLE 3; 3 [hp_X]/1; [hp_X]/1 48951-3114_fba19494-0080-4a3e-800d-25c4661b08ff 48951-3114 HUMAN OTC DRUG Colon 6 Colon 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS COLON 6 [hp_X]/mL 48951-3115_581749d2-48be-407e-ba51-bef291c41b93 48951-3115 HUMAN OTC DRUG Colon 8 Special Order Colon 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS COLON 8 [hp_X]/mL 48951-3116_03e7e945-f9db-40ba-8e45-76d457262307 48951-3116 HUMAN OTC DRUG Conchae 5 comp. Conchae 5 comp. POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OSTREA EDULIS SHELL; QUERCUS ROBUR WHOLE 1; 4 [hp_X]/g; [hp_X]/g 48951-3117_33f97977-40c2-48ff-94df-eb0ce511f23f 48951-3117 HUMAN OTC DRUG Conchae Argentum Conchae Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMANITA MUSCARIA FRUITING BODY; ASPLENIUM SCOLOPENDRIUM WHOLE; DRYOPTERIS FILIX-MAS ROOT; OSTREA EDULIS SHELL; PTERIDIUM AQUILINUM WHOLE; SILVER 7; 3; 3; 6; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3118_3b266fd2-5c95-4afb-bde7-cebd12a59129 48951-3118 HUMAN OTC DRUG Conchae Argentum Conchae Argentum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMANITA MUSCARIA FRUITING BODY; ASPLENIUM SCOLOPENDRIUM TOP; DRYOPTERIS FILIX-MAS ROOT; OSTREA EDULIS SHELL; PTERIDIUM AQUILINUM WHOLE; SILVER 7; 3; 3; 6; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3119_f7882132-e05b-4f28-8b2a-79ad1b436f04 48951-3119 HUMAN OTC DRUG Conchae Urtica Special Order Conchae Urtica Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMANITA MUSCARIA FRUITING BODY; COLLOIDAL SILICON DIOXIDE; EQUISETUM ARVENSE TOP; FORMICA RUFA; LEVISTICUM OFFICINALE ROOT; MAMMAL LIVER; MERCURY; OSTREA EDULIS SHELL; PORK KIDNEY; SILVER; SLOE; THUJA OCCIDENTALIS WHOLE; URTICA DIOICA ROOT 7; 12; 2; 2; 2; 4; 14; 5; 4; 5; 2; 6; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3121_8e2db638-b4df-462c-94de-a6cc7b15d628 48951-3121 HUMAN OTC DRUG Conjunctiva Argentum Special Order Conjunctiva Argentum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; BOS TAURUS EYE; COLLOIDAL SILICON DIOXIDE; ECHINACEA, UNSPECIFIED; SILVER 20; 30; 20; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3122_7e0bd2f4-1e59-4be5-86de-0ea005b322df 48951-3122 HUMAN OTC DRUG Conjunctiva Argentum Conjunctiva Argentum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; BOS TAURUS EYE; COLLOIDAL SILICON DIOXIDE; ECHINACEA, UNSPECIFIED; SILVER 20; 30; 20; 3; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3124_3a9c0463-91d0-4cd8-86d2-8cd0ff07400a 48951-3124 HUMAN OTC DRUG Copper Oxide 0.4 Copper Oxide 0.4 OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC OXIDE 1 [hp_X]/g 48951-3125_e75ea0cf-a30a-49f6-a78e-16c59bce5f95 48951-3125 HUMAN OTC DRUG Cor 5 Special Order Cor 5 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART 5 [hp_X]/mL 48951-3127_5b6865b1-1088-4b52-9842-33e854b118e8 48951-3127 HUMAN OTC DRUG Cor Aurum 17/10 Cor Aurum 17/10 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 17; 10; 4; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3128_90f0e853-5c08-457b-b887-cf75a48c4220 48951-3128 HUMAN OTC DRUG Cor Aurum 6/10 Special Order Cor Aurum 6/10 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 6; 10; 4; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3130_a7ce3f8e-9eb0-427c-a3c5-8a7f8d734950 48951-3130 HUMAN OTC DRUG Corallium rubrum Stibium 6 Corallium rubrum Stibium 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; CORALLIUM RUBRUM EXOSKELETON 6; 6 [hp_X]/mL; [hp_X]/mL 48951-3131_c713c542-615f-4f0e-af88-178e3863b8ab 48951-3131 HUMAN OTC DRUG Cordia Cordia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ARNICA MONTANA FLOWER; CONVALLARIA MAJALIS; DIGITALIS; EQUISETUM ARVENSE TOP; GOLD; HAWTHORN LEAF WITH FLOWER; LEONURUS CARDIACA FLOWERING TOP; MELISSA OFFICINALIS; ROSMARINUS OFFICINALIS FLOWERING TOP; RUTA GRAVEOLENS FLOWERING TOP; SAFFRON; SANGUINARIA CANADENSIS ROOT; SEDUM ROSEUM WHOLE; SELENICEREUS GRANDIFLORUS STEM; ST. JOHN'S WORT 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3132_f03010f1-f722-4c0a-bd1c-33033429a0d9 48951-3132 HUMAN OTC DRUG Corpus Succinum Special Order Corpus Succinum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMBER; BOS TAURUS EYE 6; 6 [hp_X]/mL; [hp_X]/mL 48951-3133_f11d33d3-0429-4d01-8f70-08eeebb74e54 48951-3133 HUMAN OTC DRUG Cortisonum 30 Special Order Cortisonum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CORTISONE 30 [hp_X]/mL 48951-3134_e173e293-d2b4-4d4a-8953-a0881f249b3a 48951-3134 HUMAN OTC DRUG Crataegus Nicotiana Crataegus Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; CERIUM; HAWTHORN LEAF WITH FLOWER; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; TOBACCO LEAF 6; 6; 3; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3135_af34f1a1-df60-4f04-a437-48d9e1845451 48951-3135 HUMAN OTC DRUG Crataegus Nicotiana Crataegus Nicotiana PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; CERIUM; HAWTHORN LEAF WITH FLOWER; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; TOBACCO LEAF 6; 6; 1; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3136_36506a88-df61-40b5-87db-42bb706aef73 48951-3136 HUMAN OTC DRUG Crataegus Onopordon Crataegus Onopordon LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; GOLD; HAWTHORN LEAF WITH FLOWER; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; SELENICEREUS GRANDIFLORUS STEM 6; 15; 3; 3; 2; 2; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3137_19d81d7b-4f7f-45c4-909e-3b836368749c 48951-3137 HUMAN OTC DRUG Cuprite 3 Special Order Cuprite 3 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC OXIDE 3 [hp_X]/g 48951-3138_6b004cae-375f-42df-ac14-bb62459c2d54 48951-3138 HUMAN OTC DRUG Cuprum 5 Cuprum 5 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER 5 [hp_X]/g 48951-3139_72ddefdc-0833-4610-a0b6-d5d10873fd6c 48951-3139 HUMAN OTC DRUG Cuprum Aceticum 3 Cuprum Aceticum 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC ACETATE 3 [hp_X]/mL 48951-3140_a272b9bc-f81b-42f1-b725-ddfe75b14a0b 48951-3140 HUMAN OTC DRUG Cuprum aceticum 4 Special Order Cuprum aceticum 4 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC ACETATE 4 [hp_X]/1 48951-3141_484ab8af-7d23-40e4-94f3-bb9213812fd8 48951-3141 HUMAN OTC DRUG Cuprum aceticum Nicotiana Cuprum aceticum Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARSENIC TRIOXIDE; CUPRIC ACETATE; LOBELIA SPICATA LEAF; PORK KIDNEY; TOBACCO LEAF 12; 6; 6; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3142_75c0e39c-ac90-4eaf-9b30-307b7a2f401c 48951-3142 HUMAN OTC DRUG Cuprum aceticum Nicotiana Cuprum aceticum Nicotiana PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARSENIC TRIOXIDE; CUPRIC ACETATE; LOBELIA SPICATA LEAF; PORK KIDNEY; TOBACCO LEAF 12; 6; 6; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3143_9ae615c4-f925-4caf-ae85-71c63124a7dd 48951-3143 HUMAN OTC DRUG Cuprum aceticum Zincum valerianicum Cuprum aceticum Zincum valerianicum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC ACETATE; ZINC VALERATE DIHYDRATE 5; 5 [hp_X]/mL; [hp_X]/mL 48951-3144_4e912f9e-99c2-4668-aa09-8a58f9a563b2 48951-3144 HUMAN OTC DRUG Cuprum Nicotiana Cuprum Nicotiana OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC OXIDE; MATRICARIA RECUTITA; TOBACCO LEAF 1; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-3145_1a452ea8-6e03-4d0f-9076-78dfd819be9b 48951-3145 HUMAN OTC DRUG Cuprum Stannum Cuprum Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER; NITRIC ACID; POTASSIUM ALUM; SULFURIC ACID; TIN 3; 2; 3; 2; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3146_b39484a0-dae0-4e89-9f6b-621f6d22f0b9 48951-3146 HUMAN OTC DRUG Cuprum sulfuricum 6 Cuprum sulfuricum 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC SULFATE 6 [hp_X]/mL 48951-3148_34e42193-866c-4d1f-8792-9c96360ee28b 48951-3148 HUMAN OTC DRUG Cutis (feti) 8 Special Order Cutis (feti) 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA SKIN 8 [hp_X]/mL 48951-3152_72a11b30-dc26-40ae-82eb-1a35a73d60c3 48951-3152 HUMAN OTC DRUG Cuprum Quartz (Red) Cuprum Quartz (Red) OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; CUPRIC OXIDE 1; 1 [hp_X]/g; [hp_X]/g 48951-3153_da314ac9-4b8c-41fc-a3cb-329de4089be7 48951-3153 HUMAN OTC DRUG Cuprum Quartz (Metallic) Cuprum Quartz (Metallic) OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER 1 [hp_X]/g 48951-3154_a6b0a567-ed4f-43b7-866b-2041af1d6a66 48951-3154 HUMAN OTC DRUG Chelidonium Curcuma P Chelidonium Curcuma P LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS ROOT; TURMERIC 1; 1 [hp_X]/mL; [hp_X]/mL 48951-3156_e7a86a5b-0157-42e3-8799-f18f4bd70f90 48951-3156 HUMAN OTC DRUG Citrus Urtica comp. Special Order Citrus Urtica comp. Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; COLLOIDAL SILICON DIOXIDE; LARIX DECIDUA RESIN; LEMON; QUINCE; URTICA URENS; WORMWOOD 3; 20; 3; 2; 2; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3157_bce7af2b-9749-4d1b-b19a-ee798bb51ba1 48951-3157 HUMAN OTC DRUG Cor Aurum 6/10 Special Order Cor Aurum 6/10 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 6; 10; 4; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3158_4ff65401-59f3-4e15-9470-c4bdc0be79e8 48951-3158 HUMAN OTC DRUG Crataegus Onopordon Special Order Crataegus Onopordon Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; GOLD; HAWTHORN LEAF WITH FLOWER; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; SELENICEREUS GRANDIFLORUS STEM 6; 15; 3; 1; 1; 1; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3159_44a16d1f-43d5-4c45-95d5-2edb115429c0 48951-3159 HUMAN OTC DRUG Crataegus Ferrum Saccharum Special Order Crataegus Ferrum Saccharum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAWTHORN LEAF WITH FLOWER; IRON; SUCROSE 3; 20; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3160_43f9fde7-0cf2-4acd-a34e-082c6b5de39d 48951-3160 HUMAN OTC DRUG Crotalus terrificus 30 Special Order Crotalus terrificus 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CROTALUS DURISSUS TERRIFICUS VENOM 30 [hp_X]/mL 48951-3161_94edb655-18fa-4781-b4c5-023a6ce2f757 48951-3161 HUMAN OTC DRUG Collagen 6 Special Order Collagen 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOVINE TYPE I COLLAGEN 6 [hp_X]/1 48951-3162_e15a6cfd-535c-456a-80ed-3317f0584770 48951-3162 HUMAN OTC DRUG Cuprum Stannum Special Order Cuprum Stannum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ALUMINUM HYDROXIDE; COPPER; NITRIC ACID; SULFURIC ACID; TIN 5; 5; 4; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3163_6a3eb09e-ebcd-4bfe-bcdb-954e39eb92c6 48951-3163 HUMAN OTC DRUG Colchicum e tub. 4 Special Order Colchicum e tub. 4 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLCHICUM AUTUMNALE WHOLE 4 [hp_X]/mL 48951-3164_09aaf520-4c47-4d21-9352-fa3def968cf9 48951-3164 HUMAN OTC DRUG Cor Aurum 17/10 Special Order Cor Aurum 17/10 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 17; 10; 4; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-3165_093127f0-1a9a-4064-ad62-578bdf933965 48951-3165 HUMAN PRESCRIPTION DRUG Crataegus e fol. et fructus 2 Special Order Crataegus e fol. et fructus 2 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAWTHORN LEAF WITH FLOWER 2 [hp_X]/mL 48951-3166_f028ccd0-7d24-4c65-a097-78342f9b23d5 48951-3166 HUMAN OTC DRUG Cuprum 17 Special Order Cuprum 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER 17 [hp_X]/mL 48951-3167_7928a387-57f4-4954-866d-7b06b1e815e2 48951-3167 HUMAN OTC DRUG Calc. carb. Cortex Quercus Special Order Calc. carb. Cortex Quercus Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CARBONATE ION; QUERCUS ROBUR WHOLE 30; 30 [hp_X]/mL; [hp_X]/mL 48951-3168_a533a190-b85c-405d-9013-71d8765273a5 48951-3168 HUMAN OTC DRUG Calendula Thuja Adult Size Calendula Thuja Adult Size SUPPOSITORY VAGINAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP; CANDIDA ALBICANS; ECHINACEA, UNSPECIFIED; LILIUM LANCIFOLIUM WHOLE FLOWERING; PULSATILLA VULGARIS; SILVER; SWEET MARJORAM; THUJA OCCIDENTALIS WHOLE; WOOD CREOSOTE 2; 33; 2; 3; 6; 7; 2; 3; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-3169_4b5c3968-d94d-419e-abac-7966998e1972 48951-3169 HUMAN OTC DRUG Carbo Prunus comp. Special Order Carbo Prunus comp. Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL; ATROPA BELLADONNA; CUPRIC ACETATE; LEAD MONOSILICATE; POTASSIUM PHOSPHATE, MONOBASIC; SILVER; SLOE; SULFUR 20; 20; 6; 20; 6; 20; 4; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3170_9a20f6d6-97c7-40a8-af56-771247ff5784 48951-3170 HUMAN OTC DRUG Cuprum 8 Special Order Cuprum 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER 8 [hp_X]/mL 48951-3171_6b256a10-5eca-4cc9-ae0c-aff5bbc6698b 48951-3171 HUMAN OTC DRUG Carbo Equiseti 6 Special Order Carbo Equiseti 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL 6 [hp_X]/mL 48951-3172_788cb850-d7ce-4ccb-a144-c558ec0a13fb 48951-3172 HUMAN OTC DRUG Carbo Betulae cum Methano 3 Special Order Carbo Betulae cum Methano 3 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL 3 [hp_X]/g 48951-3174_6dd933df-642c-4315-bf80-0ee43c49ccd7 48951-3174 HUMAN OTC DRUG Citrus pericarpium 10% Special Order Citrus pericarpium 10% Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON PEEL 1 [hp_X]/mL 48951-3175_d6c0763f-7fdd-40c8-b797-1b613559e1cf 48951-3175 HUMAN OTC DRUG Cuprum aceticum Zincum valerianicum Special Order Cuprum aceticum Zincum valerianicum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC ACETATE; ZINC VALERATE DIHYDRATE 5; 5 [hp_X]/1; [hp_X]/1 48951-3176_09420a54-81fa-4d70-8982-c2735ab3385c 48951-3176 HUMAN OTC DRUG Citrus Cydonia Special Order Citrus Cydonia Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON; QUINCE 2; 3 [hp_X]/g; [hp_X]/g 48951-3177_306f4e40-da4b-4d02-b4c9-f1b2ead782b0 48951-3177 HUMAN OTC DRUG Calendula 3 Special Order Calendula 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X]/mL 48951-3178_aaa75166-8284-4538-bbfb-232147f95c2c 48951-3178 HUMAN OTC DRUG Cinis comp A 21 Special Order Cinis comp A 21 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 21 [hp_X]/mL 48951-3179_b3bb9f64-1f02-4dcc-bd7a-7bd5e2896231 48951-3179 HUMAN OTC DRUG Carduus Viscum Special Order Carduus Viscum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; MILK THISTLE; VISCUM ALBUM FRUITING TOP 8; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-3181_132faa51-fa42-4ffe-8d73-3c7b89290c6a 48951-3181 HUMAN OTC DRUG Citrus Cydonia 1% Special Citrus Cydonia 1% Special LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON JUICE; QUINCE 2; 2 [hp_X]/mL; [hp_X]/mL 48951-3184_544ac849-fc96-40d3-b4f4-99edc5d8d182 48951-3184 HUMAN OTC DRUG Jasper 17 Special Order Jasper 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 17 [hp_X]/mL 48951-3185_aa72fee7-cd0a-4e49-9d69-ba328ec2828f 48951-3185 HUMAN OTC DRUG Calcium Phosphoricum 13 Special Order Calcium Phosphoricum 13 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALCIUM PHOSPHATE 13 [hp_X]/1 48951-3186_a9f7e099-2a82-41ef-85a0-58bcdeee6fa2 48951-3186 HUMAN OTC DRUG Camphor Hypericum Special Order Camphor Hypericum Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; CAMPHOR (NATURAL); GOLD; ST. JOHN'S WORT 7; 7; 2; 10; 7 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-3187_66732ceb-2d69-4ed7-bf8a-4fe66ed624c5 48951-3187 HUMAN OTC DRUG Connective Tissue 6 Special Order Connective Tissue 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS CONJUNCTIVA 6 [hp_X]/mL 48951-3188_3fb43401-3051-4c40-9fb4-3f2759245a55 48951-3188 HUMAN OTC DRUG Chamomilla 10 Special order Chamomilla 10 Special order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHAMOMILE 1 [hp_X]/g 48951-3189_f5d48688-b99c-4569-9e06-95006ee4d620 48951-3189 HUMAN OTC DRUG Coffea tosta 30 Special Order Coffea tosta 30 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COFFEA ARABICA SEED, ROASTED 30 [hp_X]/1 48951-3190_42733955-43c5-4c69-93e6-940205b742b3 48951-3190 HUMAN OTC DRUG Cuprum 12 Special Order Cuprum 12 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER 12 [hp_X]/1 48951-3191_9104f6c0-86e9-4e39-95bc-e5cddd6a490f 48951-3191 HUMAN OTC DRUG Sapphire 30 Special Order Sapphire 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ALUMINUM OXIDE 30 [hp_X]/mL 48951-3193_b35c17b5-a7dd-46fe-a9ec-ac4b8e1c3b21 48951-3193 HUMAN OTC DRUG Colchicum Sabina Special Order Colchicum Sabina Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLCHICUM AUTUMNALE WHOLE; JUNIPER BERRY 4; 3 [hp_X]/1; [hp_X]/1 48951-3194_34342573-bb52-4cd7-9489-dffbc7f1f735 48951-3194 HUMAN OTC DRUG Citrus Quartz Special Order Citrus Quartz Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; ELYMUS REPENS ROOT; LARIX DECIDUA RESIN; LEMON; LINDEN LEAF; QUINCE; SAMBUCUS NIGRA FLOWERING TOP 6; 4; 6; 2; 4; 2; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4001_c5b4dd97-16ab-4398-95fa-cddd52d65a86 48951-4001 HUMAN OTC DRUG Daphne Mezereum 30 Special Order Daphne Mezereum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DAPHNE MEZEREUM WHOLE 30 [hp_X]/mL 48951-4002_3500fae6-e832-4bdd-8f89-3ebf01fc3e19 48951-4002 HUMAN OTC DRUG Daphne mezereum 4 Daphne mezereum 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DAPHNE MEZEREUM WHOLE 4 [hp_X]/mL 48951-4009_5a79db3a-1442-4a61-a0a3-892f5c653216 48951-4009 HUMAN OTC DRUG Drosera comp. Drosera comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; DROSERA ROTUNDIFOLIA; HELLEBORUS FOETIDUS ROOT; IPECAC; MEPHITIS MEPHITIS ANAL GLAND FLUID; PROTORTONIA CACTI; QUILLAJA SAPONARIA BARK; VERATRUM ALBUM ROOT 4; 3; 4; 4; 4; 4; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4010_e542c471-e261-4df6-94cb-c2afe1f83650 48951-4010 HUMAN OTC DRUG Dulcamara comp. Dulcamara comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARSENIC TRIOXIDE; BOS TAURUS ADRENAL GLAND; LOBELIA SPICATA LEAF; SOLANUM DULCAMARA TOP 6; 5; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4011_c30d7b6e-0a62-4549-8733-5bd4c607f6ed 48951-4011 HUMAN OTC DRUG Ear Formula Ear Formula LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; COLLOIDAL SILICON DIOXIDE; LEVISTICUM OFFICINALE ROOT; PAPRIKA; PULSATILLA VULGARIS 8; 6; 12; 2; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4012_30daaeee-7c9c-4919-afab-f8dace4add49 48951-4012 HUMAN OTC DRUG Echinacea Apis Child Size Echinacea Apis Child Size SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; MERCURIUS SOLUBILIS; SILVER 3; 3; 3; 17; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-4013_e4ea4205-70ee-427f-bc2e-59f336984d39 48951-4013 HUMAN OTC DRUG Echinacea Argentum Echinacea Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; COLLOIDAL SILICON DIOXIDE; ECHINACEA, UNSPECIFIED; SILVER 20; 20; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4014_e7d04f55-7742-4593-92bb-68533b6ea41a 48951-4014 HUMAN OTC DRUG Echinacea Argentum Echinacea Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; SILVER 3; 30 [hp_X]/mL; [hp_X]/mL 48951-4015_4116cad1-7213-4b4a-8f40-5de4681c6f01 48951-4015 HUMAN OTC DRUG Echinacea Argentum Echinacea Argentum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; SILVER 2; 30 [hp_X]/1; [hp_X]/1 48951-4017_4fdd353f-42b1-4b5b-b2af-27016c529e43 48951-4017 HUMAN OTC DRUG Echinacea e rad. 50 Echinacea e rad. 50 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA ANGUSTIFOLIA 1 [hp_X]/mL 48951-4018_786da849-d703-4364-86df-abffc91aaf6a 48951-4018 HUMAN OTC DRUG Echinacea Essence Echinacea Essence LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA ANGUSTIFOLIA 1 [hp_X]/mL 48951-4019_52f1c80f-1d8d-4476-8050-d3fc6faa0e31 48951-4019 HUMAN OTC DRUG Echinacea Quartz Gum Support Echinacea Quartz Gum Support GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ALTHAEA OFFICINALIS ROOT; ANTIMONY TRISULFIDE; ATROPA BELLADONNA; COLLOIDAL SILICON DIOXIDE; ECHINACEA, UNSPECIFIED; SILVER 2; 5; 20; 20; 2; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-4020_fc94d7d7-da85-4b0b-bffa-2d18b5cf4832 48951-4020 HUMAN OTC DRUG Echinacea Quartz Gum Support Echinacea Quartz Gum Support LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY TRISULFIDE; ATROPA BELLADONNA; COLLOIDAL SILICON DIOXIDE; ECHINACEA, UNSPECIFIED; SILVER 6; 20; 20; 3; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4021_de6ebb34-d637-4360-9b39-3e49f230b7f5 48951-4021 HUMAN OTC DRUG Echinacea Thuja Echinacea Thuja LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; CHLOROPHYLL; ECHINACEA, UNSPECIFIED; EUCALYPTUS GUM; SILVER; THUJA OCCIDENTALIS WHOLE 6; 3; 3; 1; 20; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4022_af69ab80-06a6-11df-8a39-0800200c9a66 48951-4022 HUMAN OTC DRUG Echinacea Thuja Flu Fighter EUCALYPTUS GLOBULUS LEAF ECHINACEA PALLIDA THUJA OCCIDENTALIS TWIG APIS MELLIFERA SILVER NITRATE PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc APIS MELLIFERA; ECHINACEA PALLIDA; EUCALYPTUS GLOBULUS LEAF; SILVER NITRATE; THUJA OCCIDENTALIS TWIG 6; 3; 1; 20; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-4026_4a7a0424-cb69-471e-8783-84478af008e3 48951-4026 HUMAN OTC DRUG Epiphysis 8 Epiphysis 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PINEAL GLAND 8 [hp_X]/mL 48951-4027_492cf6c2-866e-4e24-b0f7-c2ef2aed3683 48951-4027 HUMAN OTC DRUG Epiphysis Plumbum Epiphysis Plumbum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PINEAL GLAND; HONEY; LEAD 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4028_dfc40bc8-fa2c-4757-964a-867135e82cda 48951-4028 HUMAN OTC DRUG Epiphysis Plumbum Epiphysis Plumbum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PINEAL GLAND; HONEY; LEAD 8; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-4030_b5519c81-020e-4eb9-82b2-f8a0f32c25b5 48951-4030 HUMAN OTC DRUG Equisetum 10 Equisetum 10 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP 1 [hp_X]/g 48951-4032_a8fc68b9-c5b9-4147-ab46-3cf83ca84b09 48951-4032 HUMAN OTC DRUG Ferrum phosphoricum 8 Special Order Ferrum phosphoricum 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERROSOFERRIC PHOSPHATE 8 [hp_X]/mL 48951-4034_1889b348-eacb-4600-892b-36dd40278ce3 48951-4034 HUMAN OTC DRUG Equisetum ex herba 15 Special Order Equisetum ex herba 15 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP 15 [hp_X]/mL 48951-4035_badc1031-039a-4b84-b7f0-6e92d65c3bba 48951-4035 HUMAN OTC DRUG Equisetum Formica Equisetum Formica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; FORMICA RUFA 17; 6 [hp_X]/mL; [hp_X]/mL 48951-4036_003dbac1-7df8-48c7-864d-49791327551b 48951-4036 HUMAN OTC DRUG Equisetum Formica Equisetum Formica PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; FORMICA RUFA 17; 6 [hp_X]/1; [hp_X]/1 48951-4037_05127f5e-e561-4484-8bda-62966b69eec0 48951-4037 HUMAN OTC DRUG Equisteum Iris Rash Relief Equisteum Iris Rash Relief OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. C12-17 ALKANE; CALENDULA OFFICINALIS FLOWERING TOP; EQUISETUM ARVENSE TOP; SULFUR 2; 2; 2; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-4038_1cba2514-a92a-43d8-8a3d-ada597440432 48951-4038 HUMAN OTC DRUG Equisetum limosum Rubellite 30 Equisetum limosum Rubellite 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; EQUISETUM ARVENSE TOP 30; 30 [hp_X]/mL; [hp_X]/mL 48951-4039_f1165203-c6e8-4a5e-b030-39cb7dd50603 48951-4039 HUMAN OTC DRUG Equisetum Silicea Equisetum Silicea LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; EQUISETUM ARVENSE TOP 3; 3 [hp_X]/mL; [hp_X]/mL 48951-4040_6dcc58d1-bc6e-4156-81c4-fad2b8848afc 48951-4040 HUMAN OTC DRUG Equisetum Stannum Equisetum Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; TIN 17; 8 [hp_X]/mL; [hp_X]/mL 48951-4041_0c4fdb60-7280-4502-a5c4-06cb0003a8b5 48951-4041 HUMAN OTC DRUG Equisetum Stannum Special Order Equisetum Stannum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; TIN 17; 8 [hp_X]/1; [hp_X]/1 48951-4042_d06477de-8a32-4fc0-a891-d690d4aaf45a 48951-4042 HUMAN OTC DRUG Equisetum Viscum Equisetum Viscum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; PORK KIDNEY; VISCUM ALBUM FRUITING TOP 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4043_664db47a-df2a-433a-99b0-8fe00fd818fc 48951-4043 HUMAN OTC DRUG Equisetum Viscum Equisetum Viscum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; PORK KIDNEY; VISCUM ALBUM FRUITING TOP 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-4046_1ba7f304-4364-45ab-8dfd-525a6d9fb334 48951-4046 HUMAN OTC DRUG Eucalyptus Cuprum sulf. Eucalyptus Cuprum sulf. PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC SULFATE; EUCALYPTUS GUM 5; 1 [hp_X]/1; [hp_X]/1 48951-4047_30bb27e9-3778-4d5e-a893-fae1fd8afd7e 48951-4047 HUMAN OTC DRUG Eucalyptus Cuprum sulfuricum Special Order Eucalyptus Cuprum sulfuricum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC SULFATE; EUCALYPTUS GUM 6; 1 [hp_X]/mL; [hp_X]/mL 48951-4048_6fcdc0c5-e533-4c63-97d4-aaef46b4483a 48951-4048 HUMAN OTC DRUG Eucalyptus e fol. 5 Eucalyptus e fol. 5 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EUCALYPTUS GUM 5 [hp_X]/mL 48951-4049_1c56b978-79f0-421b-a43d-ab589e667faf 48951-4049 HUMAN OTC DRUG Eupatorium comp. Eupatorium comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; LACHESIS MUTA VENOM; PHOSPHORUS 6; 6; 5; 12; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4051_e7644867-a02d-459d-abce-a8d4eff6fafd 48951-4051 HUMAN OTC DRUG Euphrasia Euphrasia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Euphrasia EUPHRASIA STRICTA 3 [hp_X]/mL 48951-4054_dcf29b6e-e7f9-4164-98f8-810b77f01508 48951-4054 HUMAN OTC DRUG Ferrum 5 Ferrum 5 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 5 [hp_X]/g 48951-4055_8763d410-d249-44a0-9c12-6f93cb956dd5 48951-4055 HUMAN OTC DRUG Ferum Acidum cholalicum 4 Special Order Ferum Acidum cholalicum 4 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHOLIC ACID; FERROUS GLUCONATE; HONEY 4; 4; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-4056_285f9663-84b1-42d2-9ecd-43a96b8b20c2 48951-4056 HUMAN OTC DRUG Ferrum arsenicosum 30 Special Order Ferrum arsenicosum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERROUS ARSENATE 30 [hp_X]/mL 48951-4057_6abd94dd-e215-46dd-8077-e6d430af42a6 48951-4057 HUMAN OTC DRUG Ferrum arsenicosum 6 Ferrum arsenicosum 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERROUS ARSENATE 6 [hp_X]/mL 48951-4059_91f43b36-1e5b-4617-afdd-24b7b4636841 48951-4059 HUMAN OTC DRUG Ferrum phosphoricum 6 Ferrum phosphoricum 6 POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERROSOFERRIC PHOSPHATE 6 [hp_X]/g 48951-4060_90763916-02a4-4671-a356-e20777f3890a 48951-4060 HUMAN OTC DRUG Equisetum cum sulfure tosta 6 Equisetum cum sulfure tosta 6 POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; SULFUR 6; 6 [hp_X]/1; [hp_X]/1 48951-4061_ccc24d62-e11c-46c8-9c54-5293b4c13526 48951-4061 HUMAN OTC DRUG Ferrum Quartz Headache Relief Ferrum Quartz Headache Relief TABLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERROUS CATION; SULFUR 1; 1 [hp_X]/1; [hp_X]/1 48951-4062_d1ae674a-9865-40e5-9b42-6bcf77fe3b0d 48951-4062 HUMAN OTC DRUG Ferrum Quartz Ferrum Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; IRON; SANGUINARIA CANADENSIS ROOT; SULFUR 20; 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4063_f7e1b031-7297-4764-87a9-59242d6b09f0 48951-4063 HUMAN OTC DRUG Ferrum Quartz Headache Relief Pellets IRON SANGUINARIA CANADENSIS SULFUR SILICON DIOXIDE PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc IRON; SANGUINARIA CANADENSIS; SILICON DIOXIDE; SULFUR 8; 6; 20; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-4064_a419b3a2-9305-49b7-a022-51c9cd5f39ae 48951-4064 HUMAN OTC DRUG Ferrum rosatum Graphites Ferrum rosatum Graphites LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERRIC OXIDE RED; GRAPHITE; IRON; SEDUM ROSEUM WHOLE 3; 17; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4065_d9361333-1ac4-423f-91ba-f3a17e6efd51 48951-4065 HUMAN OTC DRUG Ferrum sidereum Pancreas 10/4 Ferrum sidereum Pancreas 10/4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON; SUS SCROFA PANCREAS 10; 4 [hp_X]/mL; [hp_X]/mL 48951-4066_3aa7e04f-ee9c-4744-bbec-65520b8c3447 48951-4066 HUMAN OTC DRUG Ferrum sidereum 20 Ferrum sidereum 20 TABLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 20 [hp_X]/1 48951-4067_2b33112e-7e28-44b4-a937-4eb39cd95f3f 48951-4067 HUMAN OTC DRUG Ferrum sidereum 21 Special Order Ferrum sidereum 21 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 21 [hp_X]/mL 48951-4068_ba9675b7-6ece-424e-89f0-d0aef1c454e3 48951-4068 HUMAN OTC DRUG Ferrum sidereum 30 Special Order Ferrum sidereum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 30 [hp_X]/mL 48951-4070_e1329c2a-ad00-4d2e-b53b-16a3615964be 48951-4070 HUMAN OTC DRUG Ferrum sidereum 6 Ferrum sidereum 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 6 [hp_X]/mL 48951-4071_18055b20-e754-4b10-8b58-8a7c74abaf5a 48951-4071 HUMAN OTC DRUG Ferrum sidereum Sulfur Ferrum sidereum Sulfur LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; IRON; SULFUR 20; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4072_bf9d9b31-9e4c-417c-859d-62967fd55ed1 48951-4072 HUMAN OTC DRUG Ferrum sidereum 21 Special Order Ferrum sidereum 21 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 21 [hp_X]/mL 48951-4073_3e7fcc25-611c-482b-88a2-ba03bec562e1 48951-4073 HUMAN OTC DRUG Ferrum sidereum 6 Ferrum sidereum 6 POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 6 [hp_X]/g 48951-4074_97f76c22-4f04-4560-9be5-2e8994981fc8 48951-4074 HUMAN OTC DRUG Ferrum silicicum Urtica Ferrum silicicum Urtica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANISE; COLLOIDAL SILICON DIOXIDE; FERRIC OXIDE RED; URTICA DIOICA 3; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4075_3358544f-71d1-4880-9659-b27a39c2aa70 48951-4075 HUMAN OTC DRUG Ferrum silicicum Urtica Ferrum silicicum Urtica PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANISE; COLLOIDAL SILICON DIOXIDE; FERRIC OXIDE RED; URTICA DIOICA ROOT 3; 6; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-4076_8321e4b3-3688-4876-9d83-d0f6dd6102b4 48951-4076 HUMAN OTC DRUG Ferrum silicicum Urtica Ferrum silicicum Urtica POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; FERRIC OXIDE RED; URTICA DIOICA 5; 3; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-4077_d0fcb1e0-5f68-4a8d-86a7-6b01d0d3a135 48951-4077 HUMAN OTC DRUG Flores Formica Flores Formica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA; VESPA CRABRO; WHEAT 6; 6; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4081_43494917-73f4-4d6f-bb4b-fd4a27bfccf8 48951-4081 HUMAN OTC DRUG Formic acid 1 Special Order Formic acid 1 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMIC ACID 2 [hp_X]/mL 48951-4082_b5179c55-1679-4da6-82da-fe6191c986df 48951-4082 HUMAN OTC DRUG Formica 3 Formica 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 3 [hp_X]/mL 48951-4083_0b6dbd3f-1b9f-4b84-81bc-013318b822a8 48951-4083 HUMAN OTC DRUG Fomica 7 Special Order Fomica 7 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 7 [hp_X]/mL 48951-4084_efcee02c-5536-4ce7-8b02-fa531bdf85a6 48951-4084 HUMAN OTC DRUG Formica Apis Formica Apis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; FORMICA RUFA 3; 3 [hp_X]/mL; 1/mL 48951-4085_3ab5f122-636d-4179-9fb4-6a67487b6458 48951-4085 HUMAN OTC DRUG Formica Apis Formica Apis PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; FORMICA RUFA 3; 3 [hp_X]/1; [hp_X]/1 48951-4086_f2dee3bc-db26-4950-930d-054bf47ac2da 48951-4086 HUMAN OTC DRUG Formica Arnica Formica Arnica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; FORMICA RUFA; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE 3; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4087_711b0b9a-851a-4ce8-a1e8-b099c54fd8c5 48951-4087 HUMAN OTC DRUG Formica Arnica Formica Arnica PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; FORMICA RUFA; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE 3; 4; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-4088_4b480659-1011-4d0c-addc-7eda24bf4f5d 48951-4088 HUMAN OTC DRUG Formica ex animale 4 Formica ex animale 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 4 [hp_X]/mL 48951-4089_aaae80d4-44de-4098-bf3c-0c19cd778260 48951-4089 HUMAN OTC DRUG Formica Oxalis Formica Oxalis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA; OXALIS MONTANA LEAF 5; 3 [hp_X]/mL; [hp_X]/mL 48951-4090_9468eb39-a0a1-4482-ac3b-ea7a91c7a805 48951-4090 HUMAN OTC DRUG Formica Oxalis Formica Oxalis PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA; OXALIS MONTANA LEAF 5; 3 [hp_X]/1; [hp_X]/1 48951-4092_0cfddf89-f40b-4e16-99c9-daf647a23acc 48951-4092 HUMAN OTC DRUG Fragaria Vitis Liver Support Fragaria Vitis Liver Support LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FRAGARIA VESCA WHOLE; HONEY; VITIS VINIFERA LEAF 2; 2; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4093_c2200730-87b0-4cf5-9cdc-20f74c615d86 48951-4093 HUMAN OTC DRUG Fragaria Vitis Liver Support Fragaria Vitis Liver Support TABLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FRAGARIA VESCA WHOLE; VITIS VINIFERA LEAF 1; 1 [hp_X]/1; [hp_X]/1 48951-4095_a2d08a2a-e075-422d-90e3-182ead01b2fb 48951-4095 HUMAN OTC DRUG Ferrum sidereum 20 Ferrum sidereum 20 POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 20 [hp_X]/g 48951-4096_24cb21ef-7e35-418e-be1f-443b0edbcc61 48951-4096 HUMAN OTC DRUG Formica ex animale 3/15 Formica ex animale 3/15 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 3 [hp_X]/mL 48951-4097_3ed7dcfe-ef2e-48d4-b690-a977ac26c054 48951-4097 HUMAN OTC DRUG Dioscorea batata Special Order Dioscorea batata Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHINESE YAM; FRANKINCENSE; GOLD; MYRRH 16; 9; 12; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-4098_5aece644-f4d5-4621-933c-6dde29b7064f 48951-4098 HUMAN OTC DRUG Dioscorea batata 16 Special Order Dioscorea batata 16 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHINESE YAM 16 [hp_X]/1 48951-4099_1943586f-b095-4854-a916-ab5ac97955fc 48951-4099 HUMAN OTC DRUG Echinacea Thuja Special Order Echinacea Thuja Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; CHLOROPHYLL; ECHINACEA, UNSPECIFIED; EUCALYPTUS GUM; SILVER; THUJA OCCIDENTALIS WHOLE 6; 3; 3; 1; 20; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4100_add5f6f1-e14c-42df-a999-f200ab61fb81 48951-4100 HUMAN OTC DRUG Ferrum sidereum Pancreas 10/4 Special Order Ferrum sidereum Pancreas 10/4 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON; SUS SCROFA PANCREAS 10; 4 [hp_X]/1; [hp_X]/1 48951-4101_2ff11a4d-436a-49f7-bbd3-ea7d41115e53 48951-4101 HUMAN OTC DRUG Ferrum phos. 6 Special Order Ferrum phos. 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 6 [hp_X]/1 48951-4102_e1df8dff-c26f-48fe-88a9-b7448713c3dd 48951-4102 HUMAN OTC DRUG Formica Stibium comp. Special Order Formica Stibium comp. Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; COLLOIDAL SILICON DIOXIDE; FORMICA RUFA; SUS SCROFA LUNG 8; 12; 15; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-4103_4730618a-c415-4cd2-bf5a-23ca20fad7a4 48951-4103 HUMAN OTC DRUG Ferrum rosatum Graphites Special Order Ferrum rosatum Graphites Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERRIC OXIDE RED; GRAPHITE; IRON; SEDUM ROSEUM WHOLE 3; 17; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-4104_a83dced4-0f2e-47c8-a315-fd6d1ef6b5b2 48951-4104 HUMAN OTC DRUG Ferrum 8 Special Order Ferrum 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 8 [hp_X]/mL 48951-4105_0fd89d87-cae6-476a-bc7c-380a20f8ae99 48951-4105 HUMAN OTC DRUG Eucalyptus comp. Special Order Eucalyptus comp. Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DROSERA ROTUNDIFOLIA; PETASITES HYBRIDUS ROOT; PLANTAGO MAJOR LEAF 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-4106_f311ad71-5172-40c2-ac8f-2137810c5ae1 48951-4106 HUMAN OTC DRUG Flores Formica Special Order Flores Formica Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA; VESPA CRABRO; WHEAT 6; 6; 15 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-4107_09e3d6f4-cc8b-4fe1-af13-42367022b754 48951-4107 HUMAN OTC DRUG Formica 60 Special Order Formica 60 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 60 [hp_X]/mL 48951-4108_6cd594bc-98bb-4bda-8f34-64a8d3d2ec5d 48951-4108 HUMAN OTC DRUG Ferrum picrinicum 8 Special Order Ferrum picrinicum 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERROUS PICRATE 8 [hp_X]/mL 48951-4109_0d854bf0-a54c-432d-bab3-d212c62c6309 48951-4109 HUMAN OTC DRUG Equisetum ex herba 30 Special Order Equisetum ex herba 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP 30 [hp_X]/mL 48951-4110_c4d9e14d-06a5-441d-9d87-c16a3f2b57bc 48951-4110 HUMAN OTC DRUG Formica 6 Special Order Formica 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 6 [hp_X]/mL 48951-4111_6eadebee-5727-49aa-b795-bc0044775a8b 48951-4111 HUMAN OTC DRUG Funiculus umbilicalis 30 Special Order Funiculus umbilicalis 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA UMBILICAL CORD 30 [hp_X]/mL 48951-4112_7f53d6c2-5eaa-45ed-8ea6-d3f23229230d 48951-4112 HUMAN OTC DRUG Dioscorea batata Prunus Special Order Dioscorea batata Prunus Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; CHINESE YAM; FRANKINCENSE; GOLD; MYRRH; SLOE 5; 16; 9; 12; 9; 5 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-4113_e61dbde8-ea05-4437-a281-f2a4298ffcdf 48951-4113 HUMAN OTC DRUG Formica 12 Special Order Formica 12 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 12 [hp_X]/mL 48951-4114_d1c436f9-f205-4ad5-b141-e997a2c5cc4b 48951-4114 HUMAN OTC DRUG Ferrum 8 Special Order Ferrum 8 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 8 [hp_X]/1 48951-4115_c4a3b8d9-0333-4e28-af39-4108acfa0049 48951-4115 HUMAN OTC DRUG Equisetum ex herba 1 Special Order Equisetum ex herba 1 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP 2 [hp_X]/1 48951-4116_756d5ecc-8efd-40aa-a39d-1af160bfea21 48951-4116 HUMAN OTC DRUG Formica 30 Special Order Formica 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 30 [hp_X]/mL 48951-4117_6ae020a8-40ea-49f0-b641-1b6114da9ac1 48951-4117 HUMAN OTC DRUG Ferrum sidereum 6 Special Order Ferrum sidereum 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 6 [hp_X]/mL 48951-4118_d1fce0ab-85b7-441d-a0d0-e64dc7bd7dca 48951-4118 HUMAN OTC DRUG Echinacea e rad. 3 Special Order Echinacea e rad. 3 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA ANGUSTIFOLIA 3 [hp_X]/1 48951-4119_bde47288-e145-4cc3-8c9a-c12c6db8b94d 48951-4119 HUMAN OTC DRUG Femur 9 Special Order Femur 9 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BONE 9 [hp_X]/mL 48951-4121_2e44ad2e-6e4c-4565-8d31-ab8a86c23221 48951-4121 HUMAN OTC DRUG Formica 3 Special Order Formica 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 3 [hp_X]/mL 48951-4122_7f03291c-1551-46cd-af98-2e5b372e8797 48951-4122 HUMAN OTC DRUG Funiculus umbilicalis 6 Special Order Funiculus umbilicalis 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA UMBILICAL CORD 6 [hp_X]/mL 48951-5001_3a8be78d-ad2f-4f24-ae01-4950b920ce2e 48951-5001 HUMAN OTC DRUG Galena Larix Special Order Galena Larix Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS EYE; CLAVICEPS PURPUREA SCLEROTIUM; LARIX DECIDUA RESIN; LEAD SULFIDE 12; 6; 10; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-5002_9eef1834-81a5-47ca-9d3f-d2dcd4e4f228 48951-5002 HUMAN OTC DRUG Galena Larix Galena Larix PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS EYE; CLAVICEPS PURPUREA SCLEROTIUM; LARIX DECIDUA RESIN; LEAD SULFIDE 6; 6; 6; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-5004_87c25f90-1108-49d4-bce1-e949c50f3dd9 48951-5004 HUMAN OTC DRUG Gelsemium Bryonia Gelsemium Bryonia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BRYONIA ALBA ROOT; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT 3; 7; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-5005_c96dc354-3971-4ca7-8127-b706ab8c5d32 48951-5005 HUMAN OTC DRUG Gelsemium Bryonia Flu Relief GELSEMIUM SEMPERVIRENS ROOT BRYONIA CRETICA SUBSP. DIOICA ROOT PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc BRYONIA CRETICA SUBSP. DIOICA ROOT; GELSEMIUM SEMPERVIRENS ROOT 3; 3 [hp_X]/1; [hp_X]/1 48951-5007_38746455-8eb4-4d0c-af57-f0d4c6f34cc4 48951-5007 HUMAN OTC DRUG Gentiana Absinthium Gentiana Absinthium LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GENTIANA LUTEA ROOT; STRYCHNOS NUX-VOMICA SEED; TARAXACUM PALUSTRE ROOT; WORMWOOD 3; 6; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-5008_c2c1790d-14a3-4500-815f-23106babc1ea 48951-5008 HUMAN OTC DRUG Gentiana Absinthium Gentiana Absinthium PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GENTIANA LUTEA ROOT; STRYCHNOS NUX-VOMICA SEED; TARAXACUM PALUSTRE ROOT; WORMWOOD 1; 5; 2; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-5009_0c51210f-f29f-4541-a1ef-33170bffd7bc 48951-5009 HUMAN OTC DRUG Geum urbanum e rad. 5 Geum urbanum e rad. 5 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GEUM URBANUM ROOT 1 [hp_X]/mL 48951-5012_24b812c8-5414-493c-a055-9ba8118b91a8 48951-5012 HUMAN OTC DRUG Glandula Thymus 4 Glandula Thymus 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS THYMUS 4 [hp_X]/mL 48951-5013_5a920c39-bf24-41d9-96fe-ece3c368aa81 48951-5013 HUMAN OTC DRUG Glandula thymus 6 Special Order Glandula thymus 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy inc. BOS TAURUS THYMUS 6 [hp_X]/mL 48951-5014_bbdb895d-e977-4a97-94bf-75ec8969a79a 48951-5014 HUMAN OTC DRUG Glandula thyreoidea 3 Special Order Glandula thyreoidea 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THYROID, UNSPECIFIED 3 [hp_X]/mL 48951-5016_79550dd9-c314-4f1d-a675-c9c2582fef9c 48951-5016 HUMAN OTC DRUG Glandula thyreoidea 8 Glandula thyreoidea 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THYROID, UNSPECIFIED 8 [hp_X]/mL 48951-5019_63d4b361-d199-48ce-b1a0-281ada2d18dd 48951-5019 HUMAN OTC DRUG Glandulae suprarenales 4 Glandulae suprarenales 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND 4 [hp_X]/mL 48951-5020_b0bbabdf-40cf-4ce2-aec2-889cd6f83e32 48951-5020 HUMAN OTC DRUG Glandulae suprarenales 6 Special Order Glandulae suprarenales 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND 6 [hp_X]/mL 48951-5021_230215a2-c1dc-4234-8fd4-553c06d9ae1d 48951-5021 HUMAN OTC DRUG Glandulae suprarenales 6 Glandulae suprarenales 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND 6 [hp_X]/mL 48951-5022_ce5a62d0-bfce-46b4-b065-776ad01e0e70 48951-5022 HUMAN OTC DRUG Glandulae suprarenales 8 Special Order Glandulae suprarenales 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND 8 [hp_X]/mL 48951-5023_e259fe6c-3202-4c92-942c-2bdf9c458660 48951-5023 HUMAN OTC DRUG Glandulae Suprarenales Lien Glandulae Suprarenales Lien LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND; BOS TAURUS GALLBLADDER; BOS TAURUS SPLEEN 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-5024_cb1c9827-8816-482c-88fa-c3ef327a4149 48951-5024 HUMAN OTC DRUG Glandulae suprarenales Lien Glandulae suprarenales Lien PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND; BOS TAURUS BILE; BOS TAURUS SPLEEN 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-5027_8737317c-0ce6-4d9e-9fe2-076d6bc6b13e 48951-5027 HUMAN OTC DRUG Gnaphalium Stannum Gnaphalium Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BIFENTHRIN; BOS TAURUS BRAIN; BOS TAURUS CEREBELLUM; BOS TAURUS NERVE; BOS TAURUS PINEAL GLAND; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; SUS SCROFA EAR; TIN 20; 17; 17; 17; 17; 17; 17; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-5028_4e03fdbd-f604-4e46-adf0-77f45b29f6a7 48951-5028 HUMAN OTC DRUG Gnaphalium Stannum Gnaphalium Stannum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BIFENTHRIN; BOS TAURUS BRAIN; BOS TAURUS CEREBELLUM; BOS TAURUS NERVE; BOS TAURUS PINEAL GLAND; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; SUS SCROFA EAR; TIN 20; 17; 17; 17; 17; 17; 17; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-5030_8ea24680-6d7d-4bb7-8f42-21ed2c577491 48951-5030 HUMAN OTC DRUG Hamamelis e cortex 3 Hamamelis e cortex 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAMAMELIS VIRGINIANA TOP 3 [hp_X]/mL 48951-5031_bdbd1388-8140-4888-80a1-ac42209fdec7 48951-5031 HUMAN OTC DRUG Hamamelis Aesculus Hamamelis Aesculus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAMAMELIS VIRGINIANA TOP; HIRUDIN; HORSE CHESTNUT; MERCURY; PAEONIA OFFICINALIS ROOT; PULSATILLA VULGARIS 3; 6; 3; 17; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-5032_21d13ed9-a64d-4f7f-80a2-80fb7685f1ee 48951-5032 HUMAN OTC DRUG Hamamelis Aesculus Hamamelis Aesculus CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL; ARNICA MONTANA; CALCIUM FLUORIDE; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; KRAMERIA LAPPACEA WHOLE; MILK THISTLE; NITRIC ACID; SEPIA OFFICINALIS JUICE 11; 7; 9; 2; 2; 2; 2; 2; 7; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-5033_de464fb6-17d0-4108-81d5-d5adeeef7c6c 48951-5033 HUMAN OTC DRUG Hypophysis 6 Hypophysis 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PITUITARY GLAND 6 [hp_X]/mL 48951-5037_de6860e6-3c55-4b2b-900d-bc4810b54e63 48951-5037 HUMAN OTC DRUG Helleborus e pl. tota 2 Helleborus e pl. tota 2 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HELLEBORUS FOETIDUS ROOT 2 [hp_X]/mL 48951-5038_00a78afd-0b3f-4713-9a8e-61199b228500 48951-5038 HUMAN OTC DRUG Helleborus e pl. tota 4 Helleborus e pl. tota 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HELLEBORUS FOETIDUS ROOT 4 [hp_X]/mL 48951-5040_50e28b1e-46d5-4ae0-93b1-368e9b3ea2c8 48951-5040 HUMAN OTC DRUG Hepar Magnesium 10 Special Order Hepar Magnesium 10 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAGNESIUM HYDROXIDE; MAMMAL LIVER 10; 10 [hp_X]/mL; [hp_X]/mL 48951-5041_c21be056-923a-4269-a875-ea6d9834e8f9 48951-5041 HUMAN OTC DRUG Hepar Magnesium 4 Hepar Magnesium 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAGNESIUM HYDROXIDE; MAMMAL LIVER 4; 4 [hp_X]/mL; [hp_X]/mL 48951-5042_2e2fc86f-5090-430f-9941-dbbc2d9725c1 48951-5042 HUMAN OTC DRUG Hepar Magnesium 4 Hepar Magnesium 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAGNESIUM CATION; MAMMAL LIVER 4; 4 [hp_X]/mL; [hp_X]/mL 48951-5044_a794e07d-2a1c-46e7-9221-46e4d7abd3d4 48951-5044 HUMAN OTC DRUG Hepar Magnesium Taraxicum 4 Hepar Magnesium 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAGNESIUM HYDROXIDE; MAMMAL LIVER; TARAXACUM PALUSTRE ROOT 4; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-5045_ab9939c3-ad79-442d-b9d1-1349866041ff 48951-5045 HUMAN OTC DRUG Hepar Stannum 17/20 Hepar Stannum 17/20 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; TIN 17; 20 [hp_X]/mL; [hp_X]/mL 48951-5046_4cd6eb92-17e9-4e4e-9cfd-5ce4d4dd487d 48951-5046 HUMAN OTC DRUG Hepar Stannum 17/20 Hepar Stannum 17/20 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; TIN 17; 20 [hp_X]/1; [hp_X]/1 48951-5047_490768a5-ba2d-4f4c-bb7e-c964cca89759 48951-5047 HUMAN OTC DRUG Hepar Stannum 6/10 Heppar Stannum 6/10 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; TIN 6; 10 [hp_X]/mL; [hp_X]/mL 48951-5048_ca3a7538-6ff5-4e41-a8d9-acb636ee06bf 48951-5048 HUMAN OTC DRUG Hepar Stannum 6/10 Hepar Stannum 6/10 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; TIN 6; 10 [hp_X]/1; [hp_X]/1 48951-5049_024e7c4a-1fca-4235-bd95-0702f34bf537 48951-5049 HUMAN PRESCRIPTION DRUG Hepar sulfuris Sinus Hepar sulfuris Sinus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS NASAL MUCOSA; CALCIUM SULFIDE 8; 6 [hp_X]/mL; [hp_X]/mL 48951-5050_d3ea4498-a3c8-4a9f-9d01-f73fed638d17 48951-5050 HUMAN OTC DRUG Hepar sulfuris Sinus Hepar sulfuris Sinus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS NASAL MUCOSA; CALCIUM SULFIDE 8; 6 [hp_X]/1; [hp_X]/1 48951-5053_92785e8f-607e-4cea-a0a9-0cb9810bb0d1 48951-5053 HUMAN OTC DRUG Hepar Magnesium 6 Special Order Hepar Magnesium 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAGNESIUM HYDROXIDE; MAMMAL LIVER 6; 6 [hp_X]/mL; [hp_X]/mL 48951-5060_0f6d5654-eaa9-4c67-9d5f-52e627770b2c 48951-5060 HUMAN OTC DRUG Hypericum Bryophyllum Hypericum Bryophyllum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; MILK THISTLE; ST. JOHN'S WORT 2; 6; 6; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-5061_5ae3924b-e984-44b6-bf29-33668bf43402 48951-5061 HUMAN OTC DRUG Hypericum Bryophyllum Hypericum Bryophyllum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; MILK THISTLE; ST. JOHN'S WORT 2; 6; 6; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-5062_07a65597-e904-4ba1-b986-d849113287c6 48951-5062 HUMAN OTC DRUG Hypericum ex herba 3 Hypericum ex herba 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ST. JOHN'S WORT 3 [hp_X]/mL 48951-5064_d9e632e4-a42a-4546-abc0-606a1f806878 48951-5064 HUMAN OTC DRUG Hypericum Kali Phos. Bladder Support BERBERIS VULGARIS FRUIT HYPERICUM PERFORATUM POTASSIUM PHOSPHATE PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc BERBERIS VULGARIS FRUIT; HYPERICUM PERFORATUM; POTASSIUM PHOSPHATE, UNSPECIFIED FORM 3; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-5065_e4a803fa-cdb2-488a-8a27-3c2f5fd8e1e8 48951-5065 HUMAN OTC DRUG Hamamelis Aesculus Varicose Relief AESCULUS GLABRA NUT - HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - PAEONIA OFFICINALIS ROOT - PULSATILLA VULGARIS - DESIRUDIN - MERCURY - PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc AESCULUS GLABRA NUT; DESIRUDIN; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MERCURY; PAEONIA OFFICINALIS ROOT; PULSATILLA VULGARIS 3; 6; 3; 17; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-5067_b5caa146-1733-40ef-95a8-2dd7fcc9adde 48951-5067 HUMAN OTC DRUG Hypophysis Stannum Hypophysis Stannum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PITUITARY GLAND; TIN 8; 20 [hp_X]/1; [hp_X]/1 48951-5068_c2070a62-8fb5-44a9-9af4-53a222f78482 48951-5068 HUMAN OTC DRUG Ignatia Bryophyllum Ignatia Bryophyllum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; LACHESIS MUTA VENOM; SILVER; STRYCHNOS IGNATII SEED 3; 12; 10; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-5069_103354c9-672b-4b92-ba3f-79e8cff3c2b1 48951-5069 HUMAN OTC DRUG Ignatia Bryophyllum Ignatia Bryophyllum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; LACHESIS MUTA VENOM; SILVER; STRYCHNOS IGNATII SEED 3; 12; 10; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-5070_d1760ac3-92a0-4406-ad56-9c184085157f 48951-5070 HUMAN OTC DRUG Immunodoron Immunodoron LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; HYOSCYAMUS NIGER LEAF; MELISSA OFFICINALIS 30; 5; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-5071_13324a86-82b3-46cc-bb66-9c680a4014e2 48951-5071 HUMAN OTC DRUG Iris germanica comp. Iris germanica comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BEEF HEART; C12-17 ALKANE; CENTAUREA BENEDICTA; GOLD; HAWTHORN LEAF WITH FLOWER; PAEONIA OFFICINALIS ROOT; POTASSIUM CARBONATE 15; 6; 4; 3; 10; 3; 4; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-5072_a8391f5f-15a3-4799-994d-67c74e35074b 48951-5072 HUMAN OTC DRUG Iris germanica comp. Iris germanica comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BEEF HEART; C12-17 ALKANE; CENTAUREA BENEDICTA; GOLD; HAWTHORN LEAF WITH FLOWER; PAEONIA OFFICINALIS ROOT; POTASSIUM CARBONATE 15; 6; 4; 4; 10; 3; 4; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-5073_90d205c9-53bc-4088-b8cc-90f07b87dca2 48951-5073 HUMAN OTC DRUG Glandula thyreoidea 6 Special Order Glandula thyreoidea 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THYROID, UNSPECIFIED 6 [hp_X]/mL 48951-5074_79ff57e5-a2d8-4ea9-85f3-2936f9dc4031 48951-5074 HUMAN OTC DRUG Gl. Supra Gl. Thyr Hypophysis 6 Special Order Gl. Supra Gl. Thyr Hypophysis 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND; BOS TAURUS PITUITARY GLAND; THYROID, UNSPECIFIED 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-5075_5c6d4dfc-8994-4042-95bd-fdb35ad30ed0 48951-5075 HUMAN OTC DRUG Hepar sulfuris Sinus Special Order Hepar sulfuris Sinus Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS NASAL MUCOSA; CALCIUM SULFIDE 15; 6 [hp_X]/mL; [hp_X]/mL 48951-5076_1a24fdd8-61fd-439a-851a-04cfdbf03a30 48951-5076 HUMAN OTC DRUG Hypophysis 7 Special Order Hypophysis 7 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PITUITARY GLAND 7 [hp_X]/1 48951-5077_d135bd08-a29c-448a-8f7b-03d718f8c4e3 48951-5077 HUMAN OTC DRUG Helleborus e pl. tota 3 Special Order Helleborus e pl. tota 3 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HELLEBORUS FOETIDUS ROOT 3 [hp_X]/1 48951-5078_1c9372f4-a8ba-4ad9-9eff-6b2cf3474240 48951-5078 HUMAN OTC DRUG Geum Gentian 1 Special Order Geum Gentian 1 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GENTIANA LUTEA ROOT; GEUM URBANUM ROOT 1; 1 [hp_Q]/1; [hp_Q]/1 48951-5080_8eceefb8-8be5-495c-a8af-9b9f96f5c371 48951-5080 HUMAN OTC DRUG Glandula suprarenales dextra cum cupro Special Order Glandula suprarenales dextra cum cupro Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND; COPPER 7; 5 [hp_X]/mL; [hp_X]/mL 48951-5082_17b9a8f3-02a6-4a92-a29a-555477fa8ba9 48951-5082 HUMAN OTC DRUG Glandula supr. sinistra Mercurius Special Order Glandula supr. sinistra Mercurius Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND; MERCURY 7; 14 [hp_X]/mL; [hp_X]/mL 48951-5083_eca34ee6-b99e-48d3-8943-d96ee7566af3 48951-5083 HUMAN OTC DRUG Ginkgo 10 Special Order Ginkgo 10 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GINKGO 10 [hp_X]/mL 48951-5084_5b8173f3-fe0e-4316-a60f-2fa312b35319 48951-5084 HUMAN OTC DRUG Glandulae suprarenales 30 Special Order Glandulae suprarenales 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND 30 [hp_X]/mL 48951-5085_2115c2d3-e891-456e-8d8f-eea5373eb339 48951-5085 HUMAN OTC DRUG Glandula thyreoidea 4 Special Order Glandula thyreoidea 4 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THYROID, UNSPECIFIED 4 [hp_X]/mL 48951-5086_ca3c738f-3520-41c6-a308-23ad91e7545e 48951-5086 HUMAN OTC DRUG HCG 30/15/8 Special Order HCG 30/15/8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GONADOTROPHIN, CHORIONIC 8 1/mL 48951-5087_6ed3b032-a307-4799-a457-a0d6d96ce483 48951-5087 HUMAN OTC DRUG Hypophysis Mel Special Order Hypophysis Mel Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PITUITARY GLAND; HONEY 10; 10 [hp_X]/mL; [hp_X]/mL 48951-5088_8faf8584-0e3c-48b5-8496-88139f20c320 48951-5088 HUMAN OTC DRUG Glandulae suprarenales 3 Special Order Glandulae suprarenales 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND 3 [hp_X]/mL 48951-5089_3d698482-6a00-4304-a2e6-f22af93febaf 48951-5089 HUMAN OTC DRUG Hepar mag. Pulsatilla Tormentilla 6/12/30 Special Order Hepar mag. Pulsatilla Tormentilla 6/12/30 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAGNESIUM HYDROXIDE; MAMMAL LIVER; POTENTILLA ERECTA ROOT; PULSATILLA VULGARIS 6; 6; 30; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-5090_799c5ab6-e6db-4ccd-88c0-7a1cc828bd1d 48951-5090 HUMAN OTC DRUG Hypericum 6 Special Order Hypericum 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ST. JOHN'S WORT 6 [hp_X]/1 48951-5091_5d954e8f-d08e-4c4b-8370-a94504ff7a90 48951-5091 HUMAN OTC DRUG Glandulae suprarenales Lien Special Order Glandulae suprarenales Lien Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND; BOS TAURUS BILE; BOS TAURUS SPLEEN 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-5092_a1e548c9-ba70-4364-9906-c563a7618015 48951-5092 HUMAN OTC DRUG Hepar sulfuris 30 Special Order Hepar sulfuris 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALCIUM SULFIDE 30 [hp_X]/mL 48951-5093_c35d2507-16ad-4a87-996c-ca4a9551d323 48951-5093 HUMAN OTC DRUG Hypericum ex herba 30 Special Order Hypericum ex herba 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ST. JOHN'S WORT 30 [hp_X]/mL 48951-6000_674a4c13-c8c3-412f-8f0c-294d7bde9baa 48951-6000 HUMAN OTC DRUG Juglans Stannum Special Order Juglans Stannum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. JUGLANS REGIA LEAF; POTASSIUM PHOSPHATE, MONOBASIC; TIN 4; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-6004_fbd4dd34-0774-4d3c-8fd1-7b1269614f36 48951-6004 HUMAN OTC DRUG Kalium aceticum comp. 6 Kalium aceticum comp. 6 POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY TRISULFIDE; CORALLIUM RUBRUM EXOSKELETON; POTASSIUM ACETATE; SAFFRON 6; 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-6005_e3cafac5-b3cb-4454-8237-c0af3d9bd2e3 48951-6005 HUMAN OTC DRUG Kali Sulf. Bath Essence Kali Sulf. Bath Essence LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. POTASSIUM SULFIDE 1 [hp_X]/mL 48951-6006_def3d0fc-c7db-42fc-8233-4614de156575 48951-6006 HUMAN OTC DRUG Kalium aceticum comp. 6 Kalium aceticum comp. 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY TRISULFIDE; CORALLIUM RUBRUM EXOSKELETON; POTASSIUM ACETATE; SAFFRON 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-6007_2074e9cf-5ac1-478a-8b6d-e8ce3a189057 48951-6007 HUMAN OTC DRUG Kalium carbonicum 10 Kalium carbonicum 10 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. POTASSIUM CARBONATE 10 [hp_X]/mL 48951-6011_b57bb5dc-79b6-4074-80b6-1ea0b8671c3e 48951-6011 HUMAN OTC DRUG Kali phos. Aurum Kali phos. Aurum TABLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; FERROUS SULFATE; GOLD; POTASSIUM PHOSPHATE, MONOBASIC 5; 5; 10; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-6012_96824f2a-29ab-48be-a7d9-cfbeb080af80 48951-6012 HUMAN OTC DRUG Lachesis Belladonna Lachesis Belladonna LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; CALCIUM SULFIDE; LACHESIS MUTA VENOM; MERCURIALIS PERENNIS 4; 7; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-6013_9e543938-e93e-46cd-8636-445ebfb4fac4 48951-6013 HUMAN OTC DRUG Lachesis Belladonna Lachesis Belladonna LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; CALCIUM SULFIDE; LACHESIS MUTA VENOM; MERCURIALIS PERENNIS 4; 6; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-6014_bb863b39-c8c9-468c-9c13-88604a2b390a 48951-6014 HUMAN OTC DRUG Lachesis Belladonna Lachesis Belladonna PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; CALCIUM SULFIDE; LACHESIS MUTA VENOM; MERCURIALIS PERENNIS 4; 6; 12; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-6015_e27f76a5-27a8-436a-b794-842c5b2a618b 48951-6015 HUMAN OTC DRUG Larynx Bryonia Special Order Larynx Bryonia Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BOS TAURUS NERVE; BRYONIA ALBA ROOT; LEVISTICUM OFFICINALE ROOT; THYROID, BOVINE 20; 20; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-6016_780b4315-74e3-4376-b744-620e6836128e 48951-6016 HUMAN OTC DRUG Larynx Bryonia Larynx Bryonia PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BOS TAURUS NERVE; BRYONIA ALBA ROOT; LEVISTICUM OFFICINALE ROOT; THYROID, BOVINE 20; 20; 20; 20; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-6017_b4c94917-d524-4bc6-bd30-2bcc335dcd06 48951-6017 HUMAN OTC DRUG Larynx Levisticum Special Order Larynx Levisticum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BOS TAURUS NERVE; BOS TAURUS PARASYMPATHETIC NERVE; BRYONIA ALBA ROOT; LEVISTICUM OFFICINALE ROOT; THYROID, BOVINE 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-6018_c129edaf-4cd5-4dc4-a010-024258ba2ba8 48951-6018 HUMAN OTC DRUG Larynx Levisticum Larynx Levisticum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BOS TAURUS NERVE; BRYONIA ALBA ROOT; LEVISTICUM OFFICINALE ROOT; THYROID, BOVINE 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-6023_c302205c-807d-400c-9b09-af3e1787ebb4 48951-6023 HUMAN OTC DRUG Lemon Quartz Lemon Quartz GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharamcy Inc. SILVER 1 [hp_X]/g 48951-6024_cd89eef0-3139-11df-9aae-0800200c9a66 48951-6024 HUMAN OTC DRUG Lemon Quince Allergy Relief LEMON CHINESE QUINCE EXTRACT BERBERIS VULGARIS FRUIT SILICON DIOXIDE SPRAY NASAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc BERBERIS VULGARIS FRUIT; CHINESE QUINCE EXTRACT; LEMON; SILICON DIOXIDE 3; 2; 2; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-6025_70ee567e-96eb-4d16-94bb-89a71705e4b9 48951-6025 HUMAN OTC DRUG Lemon Quince Allergy Relief LEMON CHINESE QUINCE EXTRACT BERBERIS VULGARIS FRUIT SILICON DIOXIDE PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc BERBERIS VULGARIS FRUIT; CHAENOMELES SINENSIS FRUIT; LEMON; SILICON DIOXIDE 3; 2; 2; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-6026_2e492f49-1a96-46bf-8a29-0e8306d83ffb 48951-6026 HUMAN OTC DRUG Levico Prunus Levico Prunus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERRIC OXIDE RED; FERROUS ARSENATE; PRUNUS SPINOSA FLOWER BUD; ST. JOHN'S WORT 6; 3; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-6027_03a7de9a-6fd3-48c1-8f73-599875d237f5 48951-6027 HUMAN OTC DRUG Levico Prunus Levico Prunus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERRIC OXIDE RED; FERROUS ARSENATE; SLOE; ST. JOHN'S WORT 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-6028_e305b9cf-5a9f-485d-9854-72314565506a 48951-6028 HUMAN OTC DRUG Levisticum e rad. 3 Levisticum e rad. 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEVISTICUM OFFICINALE ROOT 3 [hp_X]/mL 48951-6029_7cb70821-7c9d-4303-b304-8b72fbc94eff 48951-6029 HUMAN OTC DRUG Levisticum e rad. 3 Levisticum e rad. 3 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEVISTICUM OFFICINALE ROOT 3 [hp_X]/1 48951-6030_0eb2eb43-ec11-4d57-8bc2-ef14e3b3f95d 48951-6030 HUMAN OTC DRUG Levisticum Quercus Levisticum Quercus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS EYE; BOS TAURUS NERVE; LEVISTICUM OFFICINALE ROOT; QUERCUS ROBUR WHOLE 8; 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-6031_9dc0c45f-71e1-4e8e-9dca-19102d7e9a65 48951-6031 HUMAN OTC DRUG Levisticum Quercus Special Order Levisticum Quercus Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS EYE; BOS TAURUS NERVE; LEVISTICUM OFFICINALE ROOT; QUERCUS ROBUR WHOLE 8; 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-6032_1db9d3e9-96ff-4e2f-bb09-a46843af675b 48951-6032 HUMAN OTC DRUG Levisticum Quercus Levisticum Quercus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS EYE; LEVISTICUM OFFICINALE ROOT; QUERCUS ROBUR WHOLE 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-6033_bbb69a29-9ac4-455b-ad78-fcbd8a30dce9 48951-6033 HUMAN OTC DRUG Lien Cichorium Lien Cichorium LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS CARTILAGE; BOS TAURUS SPLEEN; CICHORIUM INTYBUS WHOLE; EQUISETUM ARVENSE TOP; PORK KIDNEY 8; 6; 20; 20; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-6034_d05a4765-6155-43a4-9907-3659d92484cf 48951-6034 HUMAN OTC DRUG Lien Cichorium Lien Cichorium PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS CARTILAGE; BOS TAURUS SPLEEN; CICHORIUM INTYBUS WHOLE; EQUISETUM ARVENSE TOP; PORK KIDNEY 8; 6; 20; 20; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-6035_8443b44a-9a82-4608-9a07-e3bdecf033a9 48951-6035 HUMAN OTC DRUG Lien Plumbum Lien Plumbum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS SPLEEN; LEAD 6; 30 [hp_X]/mL; [hp_X]/mL 48951-6036_a371e636-c025-4f44-96e5-a03f8b8942dc 48951-6036 HUMAN OTC DRUG Lien Plumbum Special Order Lien Plumbum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS SPLEEN; LEAD 6; 30 [hp_X]/1; [hp_X]/1 48951-6040_ef178bbf-1306-47f8-abbd-5b6c12232d55 48951-6040 HUMAN OTC DRUG Lilium Viscum Lilium Viscum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ALUMINUM OXIDE; GOLDENSEAL; LILIUM LANCIFOLIUM WHOLE FLOWERING; POTASSIUM PHOSPHATE, MONOBASIC; TIN; VISCUM ALBUM FRUITING TOP 30; 3; 3; 6; 8; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-6044_add71428-196e-4a49-91c0-75ed8ba27932 48951-6044 HUMAN OTC DRUG Liver comp. Liver comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAGNESIUM CATION; MAMMAL LIVER; MILK THISTLE; TIN 4; 4; 3; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-6045_7b46c5ad-5305-4961-afee-47aa4346204b 48951-6045 HUMAN OTC DRUG Lobelia Quercus Lobelia Quercus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEAD; LOBELIA SPICATA LEAF; QUERCUS ROBUR WHOLE; VERONICA OFFICINALIS FLOWERING TOP 17; 6; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-6046_e7b8f856-de02-4b32-a137-4fc85b936627 48951-6046 HUMAN OTC DRUG Lobelia Quercus Lobelia Quercus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEAD; LOBELIA SPICATA LEAF; QUERCUS ROBUR WHOLE; VERONICA OFFICINALIS FLOWERING TOP 17; 6; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-6047_ec905a2a-9cf2-4589-a125-8488584a33cd 48951-6047 HUMAN OTC DRUG Lobelia Quercus Lobelia Quercus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEAD; LOBELIA SPICATA LEAF; QUERCUS ROBUR WHOLE; VERONICA OFFICINALIS FLOWERING TOP 17; 6; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-6048_efb9fc3f-2738-4ee6-95e0-22f190f1b0a7 48951-6048 HUMAN OTC DRUG Lycopodium Berberis Lycopodium Berberis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; CALOMEL; CHELIDONIUM MAJUS ROOT; FRAGARIA VESCA WHOLE; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; SULFIDE ION; TURMERIC; VITIS VINIFERA LEAF 3; 10; 5; 5; 5; 4; 6; 5; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-6049_7a219290-3af3-4b2f-a1bd-0c96fdc5094f 48951-6049 HUMAN OTC DRUG Lycopodium Berberis Lycopodium Berberis PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; CALOMEL; CHELIDONIUM MAJUS ROOT; FRAGARIA VESCA WHOLE; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; SULFIDE ION; TURMERIC; VITIS VINIFERA LEAF 3; 10; 5; 5; 3; 1; 6; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-6050_a07a4676-cb2f-449a-92bf-0d8cb78a1c04 48951-6050 HUMAN OTC DRUG Lymphocytes 8 Lymphocytes 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUINE THYMOCYTE IMMUNE GLOBULIN 8 [hp_X]/mL 48951-6051_4dfc21cc-439c-49e2-a605-d11b3492c3dd 48951-6051 HUMAN OTC DRUG Lysimachia Solanum 5 Lysimachia Solanum 5 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LYSIMACHIA NUMMULARIA; SOLANUM DULCAMARA FLOWER 1; 1 [hp_X]/mL; [hp_X]/mL 48951-6052_2290daa4-0ffd-4515-afce-4a7e21392261 48951-6052 HUMAN OTC DRUG Lysimachia Solanum Special Order Lysimachia Solanum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LYSIMACHIA NUMMULARIA; SOLANUM DULCAMARA FLOWER 1; 1 [hp_X]/mL; [hp_X]/mL 48951-6053_2aa00015-66ca-41b1-b856-e4c70b5caba2 48951-6053 HUMAN OTC DRUG Hepar Magnesium 6 Special Order Hepar Magnesium 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAGNESIUM HYDROXIDE; MAMMAL LIVER 6; 6 [hp_X]/1; [hp_X]/1 48951-6054_f795ae15-c999-494b-9e43-6d2a4b85b25c 48951-6054 HUMAN OTC DRUG Levisticum comp. Special Order Levisticum comp. Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LEVISTICUM OFFICINALE ROOT; MATRICARIA RECUTITA; MERCURY; PULSATILLA VULGARIS; THUJA OCCIDENTALIS WHOLE 2; 3; 3; 2; 3; 3; 15; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-6055_db50a6ca-4b9c-43c1-b93a-1382ec1dd59c 48951-6055 HUMAN OTC DRUG Liver comp. Special Order Liver comp. Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAGNESIUM HYDROXIDE; MAMMAL LIVER; MILK THISTLE; TIN 4; 4; 3; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-6056_4f957136-b1ec-4065-8c8b-2ba7509a14df 48951-6056 HUMAN OTC DRUG Kali aceticum comp 6 Special Order Kali aceticum comp 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY TRISULFIDE; CORALLIUM RUBRUM EXOSKELETON; POTASSIUM ACETATE; SAFFRON 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-6057_4ba1c57a-6678-4ed1-b85b-5e0206692584 48951-6057 HUMAN OTC DRUG Lemon Quince Special Lemon Quince Special SPRAY NASAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; COLLOIDAL SILICON DIOXIDE; LEMON JUICE; QUINCE 3; 20; 1; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-6058_d0f0787d-8cd3-4a09-8b2c-1117a8a480e6 48951-6058 HUMAN OTC DRUG Lactic acid 6 Special Order Lactic acid 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LACTIC ACID 6 [hp_X]/mL 48951-6059_ab58b526-0696-4bf2-ba4e-dbd7265cfed0 48951-6059 HUMAN OTC DRUG Ligamentum long. posterior 8 Special Order Ligamentum long. posterior 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS LIGAMENT 8 [hp_X]/mL 48951-6060_b592f41c-3c2a-4bdc-9d2f-86c7779ae5e2 48951-6060 HUMAN OTC DRUG Lymphocytes 30 Special Order Lymphocytes 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUINE THYMOCYTE IMMUNE GLOBULIN 30 [hp_X]/mL 48951-6061_f99b4169-da92-4c21-a5a6-bcf28582141a 48951-6061 HUMAN OTC DRUG Lycopodium e pl tota. 8 Special Order Lycopodium e pl tota. 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LYCOPODIUM CLAVATUM SPORE 8 [hp_X]/mL 48951-6062_bed97079-e5fd-47fa-8ad0-a68614b3b49c 48951-6062 HUMAN OTC DRUG Lycopodium e pl. tota 3 Special Order Lycopodium e pl. tota 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LYCOPODIUM CLAVATUM SPORE 3 [hp_X]/mL 48951-6063_973bde36-b06a-4e01-b443-fda937ceef26 48951-6063 HUMAN OTC DRUG Kalium phosphoricum 6 Special Order Kalium phosphoricum 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. POTASSIUM PHOSPHATE, MONOBASIC 6 [hp_X]/mL 48951-6064_da95bfe9-48ee-4b27-9bd3-2213c428cb49 48951-6064 HUMAN OTC DRUG Juglans 14 Special Order Juglans 14 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ENGLISH WALNUT 14 [hp_X]/mL 48951-6065_fbd3e47e-1ee0-4e2c-a170-0255b082902e 48951-6065 HUMAN OTC DRUG Lachesis e veneno 30 Special Order Lachesis e veneno 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LACHESIS MUTA VENOM 30 [hp_X]/mL 48951-6066_9928a59a-728c-4513-a366-98351f9e256b 48951-6066 HUMAN OTC DRUG Lymphocytes 6 Special Order Lymphocytes 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUINE THYMOCYTE IMMUNE GLOBULIN 6 [hp_X]/mL 48951-6067_5855c6bf-1c4d-4910-bd44-409c45fa27ed 48951-6067 HUMAN OTC DRUG Kalium carbonicum 12 Special Order Kalium carbonicum 12 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. POTASSIUM CARBONATE 12 [hp_X]/mL 48951-7000_ead7e1b3-d918-4145-b1d4-faa2b0bc46e7 48951-7000 HUMAN OTC DRUG Magnesite Viscum Magnesite Viscum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BOS TAURUS MAMMARY GLAND; BOS TAURUS PITUITARY GLAND; MAGNESITE; SUS SCROFA UMBILICAL CORD; VISCUM ALBUM FRUITING TOP 6; 6; 6; 8; 6; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7001_81aa317b-fede-43a4-9669-7bf20d44645c 48951-7001 HUMAN OTC DRUG Magnesite Viscum Magnesite Viscum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BOS TAURUS MAMMARY GLAND; BOS TAURUS PITUITARY GLAND; MAGNESITE; SUS SCROFA UMBILICAL CORD; VISCUM ALBUM FRUITING TOP 6; 6; 6; 8; 6; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7002_e3849ea4-4d80-49b6-9079-b32e4a220bd4 48951-7002 HUMAN OTC DRUG Magnesium carbonicum 6 Magnesium carbonicum 6 POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAGNESIUM CARBONATE 6 [hp_X]/g 48951-7004_53224f4b-e6d2-49da-aac6-7060cdab31bc 48951-7004 HUMAN OTC DRUG Magnesium sulf. Bryonia Magnesium sulf. Bryonia PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ARNICA MONTANA; BOS TAURUS OVARY; BOS TAURUS PITUITARY GLAND; BRYONIA ALBA ROOT; COLLOIDAL SILICON DIOXIDE; MAGNESIUM CATION; SUS SCROFA UMBILICAL CORD; TIN; VESPA CRABRO; VISCUM ALBUM FRUITING TOP 5; 3; 6; 6; 3; 6; 6; 6; 10; 5; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7006_55c6620b-6bc3-4dda-8366-b6784a85a205 48951-7006 HUMAN OTC DRUG Magnesium sulf. Bryonia Magnesium sulf. Bryonia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ARNICA MONTANA; BOS TAURUS OVARY; BOS TAURUS PITUITARY GLAND; BRYONIA ALBA ROOT; COLLOIDAL SILICON DIOXIDE; MAGNESIUM SULFATE; SUS SCROFA UMBILICAL CORD; TIN; VESPA CRABRO; VISCUM ALBUM FRUITING TOP 5; 3; 6; 6; 3; 6; 6; 6; 10; 5; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7009_ae914f38-6513-4198-9098-2f6f733ac6b4 48951-7009 HUMAN OTC DRUG Mamma (dextra) 6 Mamma (dextra) 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS MAMMARY GLAND 6 [hp_X]/mL 48951-7010_afb1131f-f3cc-4ffa-b0be-61e27e4d6d8b 48951-7010 HUMAN OTC DRUG Mamma (sinistra) 6 Mamma (sinistra) 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS MAMMARY GLAND 6 [hp_X]/mL 48951-7012_b88c5f22-70aa-4182-ad35-cedd63517df5 48951-7012 HUMAN OTC DRUG Mandragora Arnica Mandragora Arnica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BETULA PUBESCENS LEAF; EQUISETUM ARVENSE TOP; FORMICA RUFA; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA MENISCUS 15; 3; 15; 10; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7013_e92bf64b-39cc-47cc-b903-c0258f15964c 48951-7013 HUMAN OTC DRUG Mandragora e rad. 2 Mandragora e rad. 2 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MANDRAGORA OFFICINARUM ROOT 2 [hp_X]/mL 48951-7014_bc3ff308-da05-4507-9ed0-c73bc4884027 48951-7014 HUMAN OTC DRUG Mandragora e rad. 3 Mandragora e rad. 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MANDRAGORA OFFICINARUM ROOT 3 [hp_X]/mL 48951-7015_1600b20e-6d13-4c48-a252-c21aa097c95d 48951-7015 HUMAN OTC DRUG Mandragora Rheum Mandragora Rheum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BONE; BOVINE TYPE I COLLAGEN; FORMICA RUFA; MANDRAGORA OFFICINARUM ROOT; SILVER; SUS SCROFA PANCREAS; TARAXACUM PALUSTRE ROOT 8; 6; 6; 3; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7016_44e6f9e9-5147-4e92-8d60-73de72dd926d 48951-7016 HUMAN OTC DRUG Mandragora Rheum Mandragora Rheum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BONE; BOVINE TYPE I COLLAGEN; FORMICA RUFA; MANDRAGORA OFFICINARUM ROOT; SILVER; SUS SCROFA PANCREAS; TARAXACUM PALUSTRE ROOT 8; 6; 6; 3; 6; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7018_be60f6bc-a05d-4189-85ab-f2a2dcfc8640 48951-7018 HUMAN OTC DRUG Marjoram Melissa Adult Size Marjoram Melissa Adult Size SUPPOSITORY VAGINAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MELISSA OFFICINALIS; SWEET MARJORAM 1; 1 [hp_X]/g; [hp_X]/g 48951-7021_6b5ad555-1223-4e9e-aa7d-e97f1c544ef4 48951-7021 HUMAN OTC DRUG Medulla Arnica Medulla Arnica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; ARNICA MONTANA; BETULA PUBESCENS BARK; BOS TAURUS SPINAL CORD; CERVUS ELAPHUS WHOLE; COLLOIDAL SILICON DIOXIDE; GOLD 8; 20; 10; 8; 8; 17; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7022_70618974-118a-474e-a04e-cfd48b3e01bf 48951-7022 HUMAN OTC DRUG Medulla Arnica Medulla Arnica PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; ARNICA MONTANA; BETULA PUBESCENS BARK; BOS TAURUS SPINAL CORD; CERVUS ELAPHUS WHOLE; COLLOIDAL SILICON DIOXIDE; GOLD 8; 20; 10; 8; 8; 17; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7023_9548ee9d-3206-40e1-be45-c584f134e08c 48951-7023 HUMAN OTC DRUG Medulla ossium 8 Medulla ossium 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BONE MARROW 8 [hp_X]/mL 48951-7027_cc7aba4e-d6c7-41d4-97bf-8507f19dc1d4 48951-7027 HUMAN OTC DRUG Melissa Chamomilla Melissa Chamomilla LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; KALANCHOE DAIGREMONTIANA LEAF; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MELISSA OFFICINALIS; SEPIA OFFICINALIS JUICE 10; 3; 12; 3; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7028_3c550202-4f1d-4194-9635-64b67f5e00b8 48951-7028 HUMAN OTC DRUG Melissa Chamomilla Special Order Melissa Chamomilla Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; KALANCHOE DAIGREMONTIANA LEAF; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MELISSA OFFICINALIS; SEPIA OFFICINALIS JUICE 8; 1; 10; 1; 1; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-7029_44902730-e5db-11de-8a39-0800200c9a66 48951-7029 HUMAN OTC DRUG Melissa Chamomilla Menopause Relief MATRICARIA RECUTITA MELISSA OFFICINALIS ACONITUM NAPELLUS ROOT LACHESIS MUTA VENOM PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ACONITUM NAPELLUS ROOT; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MELISSA OFFICINALIS 10; 12; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7030_9999a612-3f8a-4ece-a7fe-378f4b9d0c04 48951-7030 HUMAN OTC DRUG Melissa Cold Sore Relief Melissa Cold Sore Relief GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MELISSA OFFICINALIS 1 [hp_X]/g 48951-7035_5a36dee7-d855-4ff2-80ac-21949055fcd9 48951-7035 HUMAN OTC DRUG Meniscus 6 Meniscus 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA MENISCUS 6 [hp_X]/mL 48951-7036_1b7da88e-9d06-439a-aa62-5db5aedb92ff 48951-7036 HUMAN OTC DRUG Mercurialis 3 Mercurialis 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURIALIS PERENNIS 3 [hp_X]/mL 48951-7037_2fa49770-4623-4106-b782-83694a5bf553 48951-7037 HUMAN OTC DRUG Mercurialis Calendula Healing Mercurialis Calendula Healing OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP; MERCURIALIS PERENNIS; ONION 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-7038_1c54ad3e-398a-4551-bb84-2d4fa905c268 48951-7038 HUMAN OTC DRUG Mercurius auratus 15 Special Order Mercurius auratus 15 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY 15 [hp_X]/mL 48951-7039_914c098e-9383-4763-8bb1-9824d7193473 48951-7039 HUMAN OTC DRUG Mercurius auratus 15 Special Order Mercurius auratus 15 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY 15 [hp_X]/mL 48951-7040_09287ad2-860f-48ce-be5c-0da2ccf28ef6 48951-7040 HUMAN OTC DRUG Mercurius auratus Pulmo Mercurius auratus Pulmo LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY; SUS SCROFA LUNG 15; 6 [hp_X]/mL; [hp_X]/mL 48951-7042_63cd9067-67b2-4368-996d-4eb7242797eb 48951-7042 HUMAN OTC DRUG Mercurius cyanatus 6 Mercurius cyanatus 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURIC CYANIDE 6 [hp_X]/mL 48951-7043_54d013d6-ab8b-4b6b-b2bd-757f07ab37c2 48951-7043 HUMAN OTC DRUG Mercurius Nasturtium Special Order Mercurius Nasturtium Special Order TABLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY; TIN; TROPAEOLUM MAJUS 5; 15; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7044_0aac8333-830e-4eea-8099-9345396adfdb 48951-7044 HUMAN OTC DRUG Mercurius vivus 8 Mercurius vivus 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY 8 [hp_X]/mL 48951-7046_1dfff8f8-f7be-4400-822a-db9198dc8e08 48951-7046 HUMAN OTC DRUG Mesenchyme Quercus Mesenchyme Quercus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; BOS TAURUS CARTILAGE; MAMMAL LIVER; PORK KIDNEY; QUERCUS ROBUR WHOLE; SUS SCROFA LUNG; SUS SCROFA PANCREAS 6; 8; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7047_f9c6b72e-b471-4dec-a746-7712826ebc01 48951-7047 HUMAN OTC DRUG Mesenchyme Quercus Mesenchyme Quercus CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; BOS TAURUS CARTILAGE; MAMMAL LIVER; PORK KIDNEY; QUERCUS ROBUR WHOLE; SUS SCROFA LUNG; SUS SCROFA PANCREAS 8; 10; 8; 8; 8; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-7048_88cd85a7-8c73-44aa-a6e2-7d65c341fbaa 48951-7048 HUMAN OTC DRUG Mesenchyme Quercus Mesenchyme Quercus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; BOS TAURUS CARTILAGE; MAMMAL LIVER; PORK KIDNEY; QUERCUS ROBUR WHOLE; SUS SCROFA LUNG; SUS SCROFA PANCREAS 6; 8; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7050_e1ad0035-5be7-4f50-af3c-465f3b22a392 48951-7050 HUMAN OTC DRUG Meteoric iron Phos Quartz Meteoric iron Phos Quartz PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; IRON; PHOSPHORUS 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7051_d53d6411-a0e3-41a2-8919-f1ec9431f6a1 48951-7051 HUMAN OTC DRUG Meteoric Iron Phosphorus Quartz Meteoric Iron Phosphorus Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; IRON; PHOSPHORUS 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7052_cabdbb19-81ae-4f0d-9866-136f4aee0243 48951-7052 HUMAN OTC DRUG Meteoric Iron Prunus Meteoric Iron Prunus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; ECHINACEA, UNSPECIFIED; IRON; PHOSPHORUS; SLOE 12; 3; 12; 6; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7053_e97b28cb-3052-4cb1-92e8-7673469d1906 48951-7053 HUMAN OTC DRUG Meteoric Iron Prunus Immune Support PRUNUS SPINOSA ECHINACEA PALLIDA PHOSPHORUS SILICON DIOXIDE IRON PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ECHINACEA PALLIDA; IRON; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; SILICON DIOXIDE 3; 12; 6; 2; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7054_6653f17c-24db-4c03-bc8d-8a69802ab30e 48951-7054 HUMAN OTC DRUG Meteoric Iron Prunus Meteoric Iron Prunus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; ECHINACEA, UNSPECIFIED; IRON; PHOSPHORUS; SLOE 12; 3; 12; 6; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7055_7a909913-415d-4b20-a0d6-c1ba7c29323a 48951-7055 HUMAN OTC DRUG Mezereum Comp. Mezereum Comp. PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CROTON TIGLIUM WHOLE; DAPHNE MEZEREUM WHOLE; LYTTA VESICATORIA; SILVER; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7057_7c95d552-02de-4971-b32b-9e0ba1a76749 48951-7057 HUMAN OTC DRUG Minimum Formica Special Order Minimum Formica Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PINEAL GLAND; FORMICA RUFA; FUCUS VESICULOSUS; PENOXSULAM; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; THYROID, UNSPECIFIED 8; 6; 6; 10; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7058_ad43626a-9807-4677-a0bb-f05ccd329f19 48951-7058 HUMAN OTC DRUG Musculus deltoides comp. 12 Special Order Musculus deltoides comp. 12 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF 12 [hp_X]/mL 48951-7061_89ad0dbe-1ece-42ce-8256-71701dd04a9f 48951-7061 HUMAN OTC DRUG Mygale Agaricus Mygale Agaricus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMANITA MUSCARIA FRUITING BODY; AVICULARIA AVICULARIA; DATURA STRAMONIUM 4; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7062_ec55013c-febe-4d45-90da-96edafb45586 48951-7062 HUMAN OTC DRUG Myristica Argentum Myristica Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS NASAL MUCOSA; DICHROMATE ION; SILVER; VIROLA SEBIFERA RESIN 7; 6; 20; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7063_285c67a0-05dd-11df-8a39-0800200c9a66 48951-7063 HUMAN OTC DRUG Myristica Argentum Sinus Relief POTASSIUM DICHROMATE SUS SCROFA NASAL MUCOSA SILVER NITRATE PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc POTASSIUM DICHROMATE; SILVER NITRATE; SUS SCROFA NASAL MUCOSA 6; 20; 7 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7064_c4f583ca-9e97-4683-876e-d989f78ec133 48951-7064 HUMAN OTC DRUG Naja e veneno 10 Naja e veneno 10 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. NAJA NAJA VENOM 10 [hp_X]/mL 48951-7066_7afcc3a7-9f64-46f3-82e4-8bb793df4d82 48951-7066 HUMAN OTC DRUG Nervus ischiadicus 6 Special Order Nervus ischiadicus 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS NERVE 6 [hp_X]/mL 48951-7068_def9cdb6-fc8c-43ae-a516-3adb244f4179 48951-7068 HUMAN OTC DRUG Nervus peronaeus 30 Special Order Nervus peronaeus 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS NERVE 30 [hp_X]/mL 48951-7069_4923a294-a37f-4eb7-94b0-ce70091562b3 48951-7069 HUMAN OTC DRUG Nervus trigeminus 30 Special Order Nervus trigeminus 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS NERVE 30 [hp_X]/mL 48951-7071_ed945911-8183-44c8-9994-fa738f606383 48951-7071 HUMAN OTC DRUG Nicotiana Carbo Nicotiana Carbo LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; LOBELIA SPICATA LEAF; MATRICARIA RECUTITA; TOBACCO LEAF 20; 12; 6; 3; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7072_4803723a-3e6d-4e12-9ca4-b4b2b1ab2070 48951-7072 HUMAN OTC DRUG Nicotiana Carbo Nicotiana Carbo PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; LOBELIA SPICATA LEAF; MATRICARIA RECUTITA; TOBACCO LEAF 20; 12; 6; 3; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7074_ef6890e0-25a6-48f5-970f-7d437f2f1837 48951-7074 HUMAN OTC DRUG Nicotiana e fol. 6 Nicotiana e fol. 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TOBACCO LEAF 6 [hp_X]/mL 48951-7075_5d69ae64-b2b3-4559-81d8-745b70c7aea8 48951-7075 HUMAN OTC DRUG Nicotiana Pulsatilla Special Order Nicotiana Pulsatilla Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; PULSATILLA VULGARIS; TOBACCO LEAF 3; 4; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7076_dd55c09c-9541-456f-a904-7c0130055bff 48951-7076 HUMAN OTC DRUG Nicotiana Pulsatilla Nicotiana Pulsatilla PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; PULSATILLA VULGARIS; TOBACCO LEAF 3; 4; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7077_4f00c342-7914-4d0e-84cd-aec9515faf55 48951-7077 HUMAN OTC DRUG Nodi Lymphatici 8 Nodi Lymphatici 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS LYMPH VESSEL 8 [hp_X]/mL 48951-7079_dbbfc11d-8567-478a-8569-51320f02ecd9 48951-7079 HUMAN OTC DRUG Nux vomica e sem. 3 Nux vomica e sem. 3 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. STRYCHNOS NUX-VOMICA SEED 3 [hp_X]/1 48951-7080_950f529a-01ee-4e09-aa95-32f4b0a3e2ef 48951-7080 HUMAN OTC DRUG Nux vomica Chamomilla Nux vomica Chamomilla LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL; MATRICARIA RECUTITA; PORK KIDNEY; ROBINIA PSEUDOACACIA BARK; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 20; 3; 7; 6; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7081_72d1c6cb-36a4-4f2d-a20a-8d6013450984 48951-7081 HUMAN OTC DRUG Nux vomica Chamomilla Nux vomica Chamomilla PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL; CHELIDONIUM MAJUS ROOT; PORK KIDNEY; ROBINIA PSEUDOACACIA BARK; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 20; 3; 7; 6; 8; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7083_b6e3e76b-d817-4dcc-b441-a1dd682448fe 48951-7083 HUMAN OTC DRUG Olivenite 17 Special Order Olivenite 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC ARSENITE 17 [hp_X]/mL 48951-7084_bed54dc0-71b8-4297-9c7c-c17c74898d3d 48951-7084 HUMAN OTC DRUG Olivenite 6 Special Order Olivenite 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER ARSENATE 6 [hp_X]/mL 48951-7086_2a9a38f4-326c-4eec-9468-934024232c25 48951-7086 HUMAN OTC DRUG Olivenite Stannum Special Order Olivenite Stannum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER ARSENATE; FERROSOFERRIC PHOSPHATE; JACOBAEA VULGARIS; PULSATILLA VULGARIS; SPINACIA OLERACEA ROOT; TIN 6; 7; 3; 6; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7088_bc3b5b2d-e346-4097-ab2c-3062a2f923ec 48951-7088 HUMAN OTC DRUG Onopordon Aurum Onopordon Aurum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 10; 3; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7089_7e42e776-47d0-4321-9e20-40ea29959d0d 48951-7089 HUMAN OTC DRUG Onopordon comp. Onopordon comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 3; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7090_d41d5916-6502-4355-ace1-13d0473f6ec1 48951-7090 HUMAN OTC DRUG Onopordon comp. Onopordon comp. PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 4; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7092_b9faf986-22e1-47a9-90e9-f90ce7ac51e4 48951-7092 HUMAN OTC DRUG Onopordon Comp. Onopordon Comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 3; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7093_cfb6391f-8ef8-4cfe-a9b4-b5797757c2b0 48951-7093 HUMAN OTC DRUG Onopordon comp. mite Onopordon comp. mite LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 2; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7094_10586194-4e80-4f09-bcd2-cad8d92d67bf 48951-7094 HUMAN OTC DRUG Organoplex Organoplex LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; MAMMAL LIVER; PORK KIDNEY; SUS SCROFA LUNG 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7095_49d36bac-caa9-4ad0-98ce-c6cda5fb4d85 48951-7095 HUMAN OTC DRUG Organoplex Organoplex PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; MAMMAL LIVER; PORK KIDNEY; SUS SCROFA LUNG 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7096_009d1de0-2bc6-11df-8a39-0800200c9a66 48951-7096 HUMAN OTC DRUG Osteodoron AM Bone Support PUMPKIN SILICON DIOXIDE CALCIUM FLUORIDE FLUORAPATITE POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc CALCIUM FLUORIDE; FLUORAPATITE; PUMPKIN; SILICON DIOXIDE 6; 6; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7097_ff723fd0-2df1-11df-8a39-0800200c9a66 48951-7097 HUMAN OTC DRUG Osteodoron PM Bone Support OYSTER SHELL CALCIUM CARBONATE, CRUDE WHITE OAK BARK CALCIUM FLUORIDE SILICON DIOXIDE POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc CALCIUM FLUORIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; WHITE OAK BARK 6; 1; 6; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7098_33203826-0c64-4bc7-b58b-de4de74ce8bc 48951-7098 HUMAN OTC DRUG Ovaria Apis Special Order Ovaria Apis Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS OVARY; ROYAL JELLY; SILVER 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7099_ce9c5891-ea5e-4ed0-b4cd-9cf6aee4c46f 48951-7099 HUMAN OTC DRUG Ovaria Apis Ovaria Apis PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS OVARY; ROYAL JELLY; SILVER 8; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7100_29457538-f360-49a1-8f23-89c9f0e69887 48951-7100 HUMAN OTC DRUG Ovarium 6 Special Order Ovarium 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS OVARY 6 [hp_X]/mL 48951-7102_47cfeba8-d2b4-45e4-b9e3-9d0a9a4bd249 48951-7102 HUMAN OTC DRUG Oxalis 10 Oxalis 10 GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OXALIS MONTANA LEAF 1 [hp_X]/g 48951-7103_e207f5a2-25a4-47c7-bda9-28838afd4fa9 48951-7103 HUMAN OTC DRUG Oxalis 20 Oxalis 20 GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OXALIS MONTANA LEAF 1 [hp_X]/g 48951-7106_5b673c35-c468-4dc2-9b5f-47b79a337f8a 48951-7106 HUMAN OTC DRUG Oxalis 5 Oxalis 5 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OXALIS MONTANA LEAF 5 [hp_X]/g 48951-7107_a61cf7a0-2e43-4661-9b1d-6185c9ae641e 48951-7107 HUMAN OTC DRUG Oxalis Belladonna Special Order Oxalis Belladonna Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; CHELIDONIUM MAJUS ROOT; GELSEMIUM SEMPERVIRENS ROOT; OXALIS MONTANA LEAF; SANGUINARIA CANADENSIS ROOT 4; 4; 4; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7108_aa9e2c2e-d46c-4773-a764-424abdf1a350 48951-7108 HUMAN OTC DRUG Oxalis Belladonna Oxalis Belladonna LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA RECUTITA; OXALIS MONTANA LEAF; SANGUINARIA CANADENSIS ROOT 4; 4; 4; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7109_b8ae6ff2-f300-4240-9515-539528d818b9 48951-7109 HUMAN OTC DRUG Oxalis e pl. tota 3 Oxalis e pl. tota 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OXALIS MONTANA LEAF 3 [hp_X]/mL 48951-7112_e089dd95-1246-4068-a602-4641532a206e 48951-7112 HUMAN OTC DRUG Opal 30 Opal 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HYDRATED SILICA 30 [hp_X]/mL 48951-7113_be66885f-cdb5-4612-aa91-7c432bc6fcc9 48951-7113 HUMAN OTC DRUG Medulla Ossium 8 Special Order Medulla Ossium 8 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BONE MARROW 8 [hp_X]/1 48951-7114_20febe31-e741-461a-8816-5f01f3a211c7 48951-7114 HUMAN OTC DRUG Magnesium sulf Conchae Special Order Magnesium sulf Conchae Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS BARK; COLLOIDAL SILICON DIOXIDE; FORMICA RUFA; MAGNESIUM SULFATE; OSTREA EDULIS SHELL; URTICA URENS 2; 30; 30; 6; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7115_2ed745e0-dddc-43ed-acf7-c1c65ff890c2 48951-7115 HUMAN OTC DRUG Osteodoron AM Special Formula Osteodoron AM Special Formula POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALCIUM FLUORIDE; COLLOIDAL SILICON DIOXIDE; CUCURBITA PEPO FLOWER; FLUORAPATITE; LEAD CARBONATE 6; 6; 3; 6; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-7116_9f3acee9-8a09-498d-b249-94205566c9f3 48951-7116 HUMAN OTC DRUG Onopordon Aurum Special Order Onopordon Aurum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 12; 5; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7117_ce1344e1-8c89-462b-a927-af3eb0d8271a 48951-7117 HUMAN OTC DRUG Musculus deltoideus comp. 8 Special Order Musculus deltoideus comp. 8 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF 8 [hp_X]/1 48951-7119_faa2fa31-5d26-43f3-ad61-ea32248cdc2c 48951-7119 HUMAN OTC DRUG Organoplex Special Order Organoplex Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; MAMMAL LIVER; PORK KIDNEY; SUS SCROFA LUNG 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7120_1a15564f-08c7-476a-9ab0-50316e0faf8b 48951-7120 HUMAN OTC DRUG Mercurius vivus 10/20/30 Special Order Mercurius vivus 10/20/30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY 10 [hp_X]/mL 48951-7121_9e7d509f-2035-41d7-a1fc-95f5c005cc80 48951-7121 HUMAN OTC DRUG Nervus facialis comp. Special Order Nervus facialis comp. Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ARNICA MONTANA; BOS TAURUS PARASYMPATHETIC NERVE; FORMICA RUFA; SILVER; ST. JOHN'S WORT 30; 30; 8; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7122_aee6dc20-b3dd-42c6-9fbc-3ce48b1e6e7e 48951-7122 HUMAN OTC DRUG Magnesium phosphoricum 6 Special Order Magnesium phosphoricum 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE 6 [hp_X]/mL 48951-7123_5c084296-f874-4a51-81a9-8fb389e32699 48951-7123 HUMAN OTC DRUG Mercurius solubilis 12 Special Order Mercurius solubilis 12 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURIUS SOLUBILIS 12 [hp_X]/mL 48951-7124_0726160c-5785-4533-80e0-964f0c2dc76e 48951-7124 HUMAN OTC DRUG Musculus deltoideus 8 Special Order Musculus deltoideus 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF 8 [hp_X]/mL 48951-7125_86263273-5687-4b43-88b8-05608f558584 48951-7125 HUMAN OTC DRUG Nervus Vagus 6 Special Order Nervus Vagus 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PARASYMPATHETIC NERVE 6 [hp_X]/mL 48951-7126_e47cbdea-c17a-4d7f-83a2-163368aae0c3 48951-7126 HUMAN OTC DRUG Nervus pudendus 8 Special Order Nervus pudendus 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS SOMATIC NERVE 8 [hp_X]/mL 48951-7127_71657854-9a6f-45b6-afbc-783c3ab61569 48951-7127 HUMAN OTC DRUG Mercurialis Calendula Prunus Special Order Mercurialis Calendula Prunus Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; MERCURIALIS PERENNIS; ONION; SLOE 2; 2; 2; 2; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-7128_15c22c9e-200c-4c3c-afd3-3a1743e5d867 48951-7128 HUMAN OTC DRUG Mandragora 5% Special Order Mandragora 5% Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MANDRAGORA OFFICINARUM ROOT 1 [hp_X]/g 48951-7129_34aad93b-d596-4c60-85f1-abc40d553f75 48951-7129 HUMAN OTC DRUG Mercurius vivus 5 Special Order Mercurius vivus 5 Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY 5 [hp_X]/g 48951-7130_09033082-ae6d-4683-a581-b58a690bdc18 48951-7130 HUMAN OTC DRUG Minium Formica Special Order Minium Formica Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARSENIC TRIOXIDE; BOS TAURUS PINEAL GLAND; FORMICA RUFA; FUCUS VESICULOSUS; KALANCHOE DAIGREMONTIANA LEAF; LEAD TETROXIDE; OXALIS MONTANA LEAF; PENOXSULAM; ROSMARINUS OFFICINALIS FLOWERING TOP; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; THYROID, UNSPECIFIED 6; 8; 6; 6; 2; 6; 2; 10; 4; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-7132_9eaf5ea9-30f7-4dfd-a5ce-8b462e427d2b 48951-7132 HUMAN OTC DRUG Mercurialis 10 Special Order Mercurialis 10 Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURIALIS PERENNIS 1 [hp_X]/g 48951-7133_11264e8b-7c0c-486c-a240-ee81bc64c706 48951-7133 HUMAN OTC DRUG Myristica Levisticum comp Special Order Myristica Levisticum comp Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS NASAL MUCOSA; LEVISTICUM OFFICINALE ROOT; POTASSIUM DICHROMATE; SILVER; VIROLA SEBIFERA RESIN 7; 3; 6; 20; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-7134_a1047918-fe5e-4e83-9851-9e80e62fb1dd 48951-7134 HUMAN OTC DRUG Nux vomica e sem. 6 Special Order Nux vomica e sem. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. STRYCHNOS NUX-VOMICA SEED 6 [hp_X]/mL 48951-7135_55ba7592-ffcd-44cf-87a4-2c3f5c32375a 48951-7135 HUMAN OTC DRUG Onyx 6 Special Order Onyx 6 Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BIFENTHRIN 6 [hp_X]/g 48951-7136_78d8ccb3-cce6-4afd-8b8b-70ddc078b2ef 48951-7136 HUMAN OTC DRUG Mercurius 10/20/30 Special Order Mercurius 10/20/30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY 10 [hp_X]/mL 48951-7137_735faa31-aa09-4a2b-b2d0-da53506c22a2 48951-7137 HUMAN OTC DRUG Mercurius auratus Pulmo Special Order Mercurius auratus Pulmo Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY; SUS SCROFA LUNG 15; 6 [hp_X]/mL; [hp_X]/mL 48951-7140_006f75dc-e2ff-4b51-b4f3-d5ec56f0221b 48951-7140 HUMAN OTC DRUG Mandragora 10 Special Order Mandragora 10 Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MANDRAGORA OFFICINARUM ROOT 1 [hp_X]/g 48951-7141_4bf32eb9-d210-4bf7-aedd-0e47edb64fdc 48951-7141 HUMAN OTC DRUG Mercurius vivus 10/20/30 Special Order Mercurius vivus 10/20/30 Special Order SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY 10 [hp_X]/g 48951-8000_c7d8c0b7-711a-402c-973f-55573ab900c1 48951-8000 HUMAN OTC DRUG Pancreas Argentum Pancreas Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA ANGUSTIFOLIA; SILVER; SUS SCROFA PANCREAS 3; 30; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8001_0a5b3234-dfc3-4982-a45a-0eb3cff023d5 48951-8001 HUMAN OTC DRUG Pancreas Argentum Pancreas Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; SILVER; SUS SCROFA PANCREAS 3; 30; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8002_b4616174-77a9-49b8-95da-480ce94a455b 48951-8002 HUMAN OTC DRUG Pancreas Equisetum Pancreas Equisetum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; QUERCUS ROBUR WHOLE; SUS SCROFA PANCREAS 6; 5; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8003_ab81ed18-ae55-41f2-844d-676256441ae9 48951-8003 HUMAN OTC DRUG Pancreas Equisetum Pancreas Equisetum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; QUERCUS ROBUR WHOLE; SUS SCROFA PANCREAS 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8004_9054dab5-30db-43ef-8e4e-f3dafd700654 48951-8004 HUMAN OTC DRUG Pancreas Meteoric Iron Pancreas Meteoric Iron LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON; ROSMARINUS OFFICINALIS FLOWERING TOP; SUS SCROFA PANCREAS 20; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8005_c4988189-4606-47f1-af6d-4e93d19c57c7 48951-8005 HUMAN OTC DRUG Pancreas Meteoric Iron Pancreas Meteoric Iron LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON; ROSMARINUS OFFICINALIS FLOWERING TOP; SUS SCROFA PANCREAS 20; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8006_8f1e6efc-ca4c-4585-923f-fcd1c7a0c515 48951-8006 HUMAN OTC DRUG Pandanus Calc. carb. Pandanus Calc. carb. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALCIUM CARBONATE; PANDANUS TECTORIUS ROOT 6; 6 [hp_X]/mL; [hp_X]/mL 48951-8007_e755bcf8-d76e-46a9-8c10-bd9517e55735 48951-8007 HUMAN OTC DRUG Pandanus Calc. Carb Pandanus Calc. Carb PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALCIUM CARBONATE; PANDANUS TECTORIUS ROOT 1; 6 [hp_X]/1; [hp_X]/1 48951-8008_406e2a06-3494-4e1c-8384-dc2b6dc962dc 48951-8008 HUMAN OTC DRUG Parathyreoidea Aurum Special Order Parathyreoidea Aurum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PARATHYROID GLAND; GOLD; SLOE 8; 10; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8009_c5d118bf-6151-4952-bdd7-c0c6479dc97b 48951-8009 HUMAN OTC DRUG Parathyreoidea Aurum Special Order Parathyreoidea Aurum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PARATHYROID GLAND; GOLD; SLOE 6; 10; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8011_42d3fd9b-af63-4721-8e8b-bcb33e23c61d 48951-8011 HUMAN OTC DRUG Passiflora Crataegus Passiflora Crataegus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAWTHORN LEAF WITH FLOWER; KALANCHOE DAIGREMONTIANA LEAF; PASSIFLORA INCARNATA FLOWERING TOP; SALIX ALBA FLOWER 3; 2; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8012_e0155b58-cfa8-4235-8046-0e6ef2f82365 48951-8012 HUMAN OTC DRUG Passiflora Crataegus Passiflora Crataegus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAWTHORN LEAF WITH FLOWER; KALANCHOE DAIGREMONTIANA LEAF; PASSIFLORA INCARNATA FLOWERING TOP; SALIX ALBA FLOWER 3; 2; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8013_e3770cf5-37cc-441d-9394-8370bda7c498 48951-8013 HUMAN OTC DRUG Passiflora ex herba 1 Special Order Passiflora ex herba 1 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PASSIFLORA INCARNATA FLOWERING TOP 2 [hp_X]/mL 48951-8016_2abd42a6-0356-45a4-9af2-ccc50f77f5d2 48951-8016 HUMAN OTC DRUG Periodontium Hypophysis Periodontium Hypophysis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF TONGUE; BOS TAURUS BONE; BOS TAURUS PITUITARY GLAND; SUS SCROFA TOOTH; TIN 8; 8; 8; 8; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8017_3024471d-8fb4-42ac-853d-317145e24157 48951-8017 HUMAN OTC DRUG Periodontium Quartz Periodontium Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; BEEF TONGUE; BOS TAURUS BONE; CALENDULA OFFICINALIS FLOWERING TOP; COLLOIDAL SILICON DIOXIDE; SILVER; SUS SCROFA TOOTH 17; 17; 17; 3; 30; 20; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8018_fa650229-6e71-4391-9663-8d93d06d6f6b 48951-8018 HUMAN OTC DRUG Petasites e rad. 1 Special Order Petasites e rad. 1 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PETASITES HYBRIDUS ROOT 1 [hp_X]/mL 48951-8019_4ec3e3b2-930b-4af4-a9d7-357871b057d1 48951-8019 HUMAN OTC DRUG Petasites Plantago Special Order Petasites Plantago Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ABIES ALBA LEAFY TWIG; FERROSOFERRIC PHOSPHATE; PETASITES HYBRIDUS ROOT; PLANTAGO MAJOR LEAF; SUS SCROFA LUNG 3; 8; 3; 3; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8020_8c4a207a-d7fa-47d1-be56-8501e699efe1 48951-8020 HUMAN OTC DRUG Petasites Plantago Petasites Plantago PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ABIES ALBA LEAFY TWIG; FERROSOFERRIC PHOSPHATE; PETASITES HYBRIDUS ROOT; PLANTAGO MAJOR LEAF; SUS SCROFA LUNG 3; 8; 3; 3; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8021_5a0abbd9-1ec5-4738-857e-cb460dec9ccd 48951-8021 HUMAN OTC DRUG Petasites Quercus Petasites Quercus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ABIES ALBA LEAFY TWIG; PETASITES HYBRIDUS ROOT; PLANTAGO MAJOR; QUERCUS ROBUR WHOLE 3; 3; 4; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8022_dad5934a-b3c9-4871-8051-4f76cbc76146 48951-8022 HUMAN OTC DRUG Petasites Veronica Petasites Veronica PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ABIES ALBA LEAFY TWIG; PETASITES HYBRIDUS ROOT; PLANTAGO MAJOR LEAF; VERONICA OFFICINALIS FLOWERING TOP 3; 3; 4; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8023_b5093f17-1a53-4f6c-af8f-5f0abde0fed6 48951-8023 HUMAN OTC DRUG Phosphorus 30 Phosphorus 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PHOSPHORUS 30 [hp_X]/mL 48951-8024_09741445-2d0d-459e-83af-dc6707306adb 48951-8024 HUMAN OTC DRUG Phosphorus 30 Special Order Phosphorus 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PHOSPHORUS 30 [hp_X]/mL 48951-8025_a68d0444-ea2d-4404-8f0d-fb24a1b7266b 48951-8025 HUMAN OTC DRUG Phosphorus 30 Special Order Phosphorus 30 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PHOSPHORUS 30 [hp_X]/1 48951-8026_c08a88d9-bee6-42b7-9c32-51db611391e9 48951-8026 HUMAN OTC DRUG Phosphorus 6 Phosphorus 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PHOSPHORUS 6 [hp_X]/mL 48951-8027_2e189dd1-7c5a-4216-a112-ceccd30a4eab 48951-8027 HUMAN OTC DRUG Phosphorus 8 Phosphorus 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PHOSPHORUS 8 [hp_X]/mL 48951-8028_98fb582c-9f99-422b-a7c3-16185654bd25 48951-8028 HUMAN OTC DRUG Phosphorus 8 Special Order Phosphorus 8 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PHOSPHORUS 8 [hp_X]/1 48951-8029_d852c306-5022-496f-b593-8be241dad28b 48951-8029 HUMAN OTC DRUG Phosphorus comp. Phosphorus comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMBER; COLLOIDAL SILICON DIOXIDE; CUPRIC SULFATE; PHOSPHORUS; ROSMARINUS OFFICINALIS FLOWERING TOP; SILVER; SUS SCROFA PANCREAS 6; 12; 4; 6; 6; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8030_2a2b8ce6-4654-4b10-8483-b4467b7c1abe 48951-8030 HUMAN OTC DRUG Phosphorus comp. Phosphorus comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMBER; COLLOIDAL SILICON DIOXIDE; CUPRIC SULFATE; PHOSPHORUS; ROSMARINUS OFFICINALIS FLOWERING TOP; SILVER; SUS SCROFA PANCREAS 6; 12; 4; 6; 6; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8031_20947d83-ffe9-47cc-8201-22e41bb80249 48951-8031 HUMAN OTC DRUG Phosphorus Tartarus Phosphorus Tartarus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY POTASSIUM TARTRATE; PHOSPHORUS 3; 6 1/mL; 1/mL 48951-8032_235c868e-247b-45cb-a7a1-e73b75741157 48951-8032 HUMAN OTC DRUG Placenta (bovis) 6 Special Order Placenta (bovis) 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PLACENTA 6 [hp_X]/mL 48951-8034_7ba55aab-2c13-4f12-9f5c-07557f50f8f5 48951-8034 HUMAN OTC DRUG Plantago Primula Plantago Primula LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HYOSCYAMUS NIGER LEAF; PLANTAGO MAJOR LEAF; PRIMULA VERIS FLOWER 3; 2; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8035_337efd57-db8e-4d6b-97ab-1cf9304faffd 48951-8035 HUMAN OTC DRUG Plantago Primula Plantago Primula PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HYOSCYAMUS NIGER LEAF; PLANTAGO MAJOR LEAF; PRIMULA VERIS FLOWER 4; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8036_73f98a63-d531-4a11-bf80-5802eec04308 48951-8036 HUMAN OTC DRUG Plantago Pyrite Plantago Pyrite LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ABIES ALBA LEAFY TWIG; BEEF LUNG; BOS TAURUS NASAL MUCOSA; BRYONIA ALBA ROOT; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; FERROUS DISULFIDE; PLANTAGO MAJOR LEAF; SAGE; THYROID, BOVINE 6; 17; 17; 8; 3; 8; 7; 17; 6; 6; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8037_e4fa47d8-b6e0-4fbd-8ccf-67932635f499 48951-8037 HUMAN OTC DRUG Plantago Pyrite Plantago Pyrite PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF LUNG; BOS TAURUS NASAL MUCOSA; BRYONIA ALBA ROOT; ECHINACEA, UNSPECIFIED; EUPATORIUM CANNABINUM; FERROSOFERRIC PHOSPHATE; FERROUS DISULFIDE; PICEA ABIES LEAF; PLANTAGO MAJOR LEAF; SAGE; THYROID, BOVINE 17; 17; 8; 3; 8; 7; 17; 6; 6; 6; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8038_a3e4fd35-4e7a-4dcd-900b-be65e6651f79 48951-8038 HUMAN OTC DRUG Plantain Beeswax Cough Relief Plantain Beeswax Cough Relief OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DROSERA ROTUNDIFOLIA; LARIX DECIDUA RESIN; PETASITES HYBRIDUS ROOT; PLANTAGO MAJOR LEAF; SAGE 4; 1; 4; 4; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-8039_34ad2313-e2c5-42eb-a810-9c312a91a423 48951-8039 HUMAN OTC DRUG Plantain Beeswax Mild Cough Relief Plantain Beeswax Mild Cough Relief OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DROSERA ROTUNDIFOLIA; LARIX DECIDUA RESIN; PETASITES HYBRIDUS ROOT; PLANTAGO MAJOR LEAF; SAGE 4; 1; 4; 4; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-8041_49af4579-0b65-11df-8a39-0800200c9a66 48951-8041 HUMAN OTC DRUG Plantain Spruce Cough PLANTAGO LANCEOLATA DROSERA ROTUNDIFOLIA ATROPA BELLADONNA CINCHONA OFFICINALIS BARK PROTORTONIA CACTI IPECAC HELLEBORUS VERATRUM ALBUM ROOT SYRUP ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA; HELLEBORUS; IPECAC; PLANTAGO LANCEOLATA; PROTORTONIA CACTI; VERATRUM ALBUM ROOT 6; 6; 5; 6; 6; 1; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8042_113bb558-234c-4173-b47a-dac9f0b9b919 48951-8042 HUMAN OTC DRUG Platinum Cichorium Platinum Cichorium LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL; CICHORIUM INTYBUS WHOLE; OXALIS MONTANA LEAF; PLATINUM; ROSMARINUS OFFICINALIS FLOWERING TOP; SUS SCROFA PANCREAS 6; 3; 3; 6; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8043_6803f2d2-2736-4d5c-9340-0ffa5e303bb0 48951-8043 HUMAN OTC DRUG Platinum Cichorium Platinum Cichorium PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL; CICHORIUM INTYBUS WHOLE; OXALIS MONTANA LEAF; PLATINIC CHLORIDE; ROSMARINUS OFFICINALIS FLOWERING TOP; SUS SCROFA PANCREAS 6; 3; 3; 6; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8046_22457f9d-9628-4135-b5be-14ee393e9756 48951-8046 HUMAN OTC DRUG Plexus coeliacus 6 Special Order Plexus coeliacus 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS NERVE 6 [hp_X]/mL 48951-8052_b2bdc00e-594b-4687-a9d0-956031cb7346 48951-8052 HUMAN OTC DRUG Plumbum 5 Plumbum 5 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEAD 5 [hp_X]/g 48951-8053_54fbfb4b-b4a8-403f-a240-90aa42785244 48951-8053 HUMAN OTC DRUG Plumbum 8 Special Order Plumbum 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEAD 8 [hp_X]/mL 48951-8055_3dd413a2-d997-49e9-a922-15d60ad31de8 48951-8055 HUMAN OTC DRUG Plumbum mellitum 12 Special Order Plumbum mellitum 12 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HONEY; LEAD 12; 12 [hp_X]/mL; [hp_X]/mL 48951-8056_ff0bc259-db09-400f-b15e-ae6ccc335981 48951-8056 HUMAN OTC DRUG Plumbum mellitum 20 Special Order Plumbum mellitum 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HONEY; LEAD 20; 20 [hp_X]/mL; [hp_X]/mL 48951-8057_ae12463c-a950-4b24-aeb6-e50982a9e61a 48951-8057 HUMAN OTC DRUG Plumbum mellitum 8 Plumbum mellitum 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HONEY; LEAD 8; 8 [hp_X]/mL; [hp_X]/mL 48951-8065_a4a1e228-ace3-42a9-9f73-7e0ce9ba0502 48951-8065 HUMAN OTC DRUG Primula Onopordon Special Order Primula Onopordon Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 4; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8066_b568432e-a458-4743-80b7-457215c5c83e 48951-8066 HUMAN OTC DRUG Primula Onopordon Stress Relief PRIMULA VERIS EXTRACT ONOPORDUM HYOSCYAMUS NIGER PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc HYOSCYAMUS NIGER; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS 4; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8067_d391ca8b-62ff-4c5a-a357-fe282edf40ea 48951-8067 HUMAN OTC DRUG Primula Scilla Special Order Primula Scilla Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; CONVALLARIA MAJALIS; DRIMIA MARITIMA BULB; HAWTHORN LEAF WITH FLOWER; HYOSCYAMUS NIGER LEAF; MELISSA OFFICINALIS; ONOPORDUM ACANTHIUM FLOWER; OSTREA EDULIS SHELL; PRIMULA VERIS FLOWER; SELENICEREUS GRANDIFLORUS STEM 6; 3; 3; 3; 4; 3; 3; 10; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8068_c67b7395-7208-4d3b-918e-d3939f0b451d 48951-8068 HUMAN OTC DRUG Primula Scilla Primula Scilla PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; CONVALLARIA MAJALIS; DRIMIA MARITIMA BULB; HAWTHORN LEAF WITH FLOWER; HYOSCYAMUS NIGER LEAF; MELISSA OFFICINALIS; ONOPORDUM ACANTHIUM FLOWER; OSTREA EDULIS SHELL; PRIMULA VERIS FLOWER; SELENICEREUS GRANDIFLORUS STEM 6; 3; 3; 3; 4; 3; 3; 10; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8076_ddc09cbb-3661-4d59-bdb9-f259180ff9e4 48951-8076 HUMAN OTC DRUG Prunus Prunus LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE 1 [hp_X]/mL 48951-8077_61625aa6-debe-42fd-a1bc-8ddb88b6b1a0 48951-8077 HUMAN OTC DRUG Prunus Iron Prunus Iron LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERRIC OXIDE RED; SLOE 6; 6 [hp_X]/mL; [hp_X]/mL 48951-8078_144ac274-dccc-4e6e-938c-07bc634a2069 48951-8078 HUMAN OTC DRUG Prunus spinosa e flor. et summ. 2 Prunus spinosa e flor. et summ. 2 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PRUNUS SPINOSA FLOWER BUD 2 [hp_X]/mL 48951-8079_48a5ed24-3dd7-4238-ab24-ac11d178497f 48951-8079 HUMAN OTC DRUG Prunus spinosa e flor. et summ. 5 Prunus spinosa e flor. et summ. 5 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE 1 [hp_X]/mL 48951-8080_65874bec-74af-4b88-8d3e-902498085870 48951-8080 HUMAN OTC DRUG Prunus spinosa e flor. et summ. 6 Prunus spinosa e flor. et summ. 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE 6 [hp_X]/mL 48951-8081_1406e3ea-13d5-436f-ba0a-f6dd0afb970b 48951-8081 HUMAN OTC DRUG Prunus spinosa e flor. et summ. 6 Special Order Prunus spinosa e flor. et summ. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE 6 [hp_X]/mL 48951-8082_c26c7548-d3a3-40ae-9dfe-1064c66f9cde 48951-8082 HUMAN OTC DRUG Prunus spinosa e summ 10% Prunus spinosa e summ 10% LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PRUNUS SPINOSA WHOLE 10 g/1 48951-8083_f5a66198-0130-4778-95b1-3e5368b52b9f 48951-8083 HUMAN OTC DRUG Pulmo 8 Pulmo 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA LUNG 8 [hp_X]/mL 48951-8084_249413ad-ff48-4169-9e2b-e5d5934148b9 48951-8084 HUMAN OTC DRUG Pulmo Bryonia Pulmo Bryonia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; SUS SCROFA LUNG 8; 6; 8; 6; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8085_5a96edeb-a63b-402c-9d38-51f07ea34f2d 48951-8085 HUMAN OTC DRUG Pulmo Echinacea Pulmo Echinacea LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ASTRAGALUS PROPINQUUS ROOT; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; LACHESIS MUTA VENOM; SILVER; SUS SCROFA LUNG; TARAXACUM PALUSTRE ROOT 3; 3; 2; 6; 12; 30; 17; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8086_9a12e84b-600f-4890-b5bd-98c26ab261a7 48951-8086 HUMAN OTC DRUG Pulmo Echinacea Pulmo Echinacea PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ASTRAGALUS PROPINQUUS ROOT; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; LACHESIS MUTA VENOM; SILVER; SUS SCROFA LUNG; TARAXACUM PALUSTRE ROOT 3; 3; 2; 6; 12; 30; 17; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8087_b6ad37e2-fcdc-409d-b62a-657fd27713b4 48951-8087 HUMAN OTC DRUG Pulmo Ferrum Pulmo Ferrum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON; SUS SCROFA LUNG 8; 17 [hp_X]/mL; [hp_X]/mL 48951-8088_136d4cb7-54cd-4cc2-9b60-58f0645660dd 48951-8088 HUMAN OTC DRUG Pulmo Ferrum Pulmo Ferrum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON; SUS SCROFA LUNG 8; 17 [hp_X]/1; [hp_X]/1 48951-8089_fc506531-19db-41fc-9fd2-85f2138d6e1e 48951-8089 HUMAN OTC DRUG Pulmo Mercurius Pulmo Mercurius LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY; SUS SCROFA LUNG 17; 8 [hp_X]/mL; [hp_X]/mL 48951-8091_4fa6f4ba-df3d-401b-8fc0-92064e26bb37 48951-8091 HUMAN OTC DRUG Pulmo Tartarus 17/8 Special Order Pulmo Tartarus 17/8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY POTASSIUM TARTRATE; IRON; SUS SCROFA LUNG 8; 8; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8092_c27c3f5e-2902-4409-bfed-8b646d1014ec 48951-8092 HUMAN OTC DRUG Pulmo Tartarus 6/8 Pulmo Tartarus 6/8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY POTASSIUM TARTRATE; SUS SCROFA LUNG 8; 6 [hp_X]/mL; [hp_X]/mL 48951-8093_03c1d5b0-2557-4051-bb21-9d2209642221 48951-8093 HUMAN OTC DRUG Pulmo Tartarus 6/8 Pulmo Tartarus 6/8 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY POTASSIUM TARTRATE; IRON; SUS SCROFA LUNG 8; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8094_7ba315ee-ded7-4960-8821-b5e2ae702002 48951-8094 HUMAN OTC DRUG Pulpa dentis 30 Special Order Pulpa dentis 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA TOOTH 30 [hp_X]/mL 48951-8097_6485c36a-82ad-430c-844e-8dde804c10df 48951-8097 HUMAN OTC DRUG Pulsatilla e flor. 6 Special Order Pulsatilla e flor. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PULSATILLA VULGARIS 6 [hp_X]/mL 48951-8098_e3274641-cd5b-489b-a974-6052d3340f04 48951-8098 HUMAN OTC DRUG Pulsatilla Tormentilla Pulsatilla Tormentilla LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAGNESIUM HYDROXIDE; MAMMAL LIVER; POTENTILLA ERECTA ROOT; PULSATILLA VULGARIS 4; 4; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8099_192675d6-5953-41f7-92e8-10d59205aeb3 48951-8099 HUMAN OTC DRUG Pulsatilla Tormentilla Pulsatilla Tormentilla LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAGNESIUM HYDROXIDE; MAMMAL LIVER; POTENTILLA ERECTA ROOT; PULSATILLA VULGARIS 4; 4; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8100_da55e5a0-e678-11de-8a39-0800200c9a66 48951-8100 HUMAN OTC DRUG Pulsatilla Tormentilla PMS Relief MAMMAL LIVER PULSATILLA VULGARIS ACHILLEA MILLEFOLIUM PELLET ORAL 20091211 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ACHILLEA MILLEFOLIUM; MAMMAL LIVER; PULSATILLA VULGARIS 30; 4; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8101_92a42820-374f-11df-9879-0800200c9a66 48951-8101 HUMAN OTC DRUG Purple Coneflower Sore Throat SAGE CALENDULA OFFICINALIS FLOWERING TOP ECHINACEA PALLIDA EUCALYPTUS GLOBULUS LEAF MERCURIC CYANIDE SILVER NITRATE ATROPA BELLADONNA SILICON DIOXIDE SPRAY ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PALLIDA; EUCALYPTUS GLOBULUS LEAF; MERCURIC CYANIDE; SAGE; SILICON DIOXIDE; SILVER NITRATE 20; 1; 1; 1; 8; 1; 20; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8102_ce765470-04e7-4084-8ddf-5ac62a982024 48951-8102 HUMAN OTC DRUG Pyrite 8 Pyrite 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERROUS DISULFIDE 8 [hp_X]/mL 48951-8103_89318414-3d01-4740-9403-136be5f62c33 48951-8103 HUMAN OTC DRUG Pyrite Salvia Pyrite Salvia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANGELICA ARCHANGELICA ROOT; FERROUS DISULFIDE; HYACINTHUS ORIENTALIS WHOLE; HYOSCYAMUS NIGER LEAF; SAGE; SILVER 5; 7; 17; 7; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8104_e360cd4b-624c-4154-bef4-e8153fe6279c 48951-8104 HUMAN OTC DRUG Pyrite Salvia Pyrite Salvia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANGELICA ARCHANGELICA ROOT; FERROUS DISULFIDE; HYACINTHUS ORIENTALIS WHOLE; HYOSCYAMUS NIGER LEAF; SAGE; SILVER 5; 7; 17; 7; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8105_fb3de630-e67a-11de-8a39-0800200c9a66 48951-8105 HUMAN OTC DRUG Pyrite Salvia Scratchy Throat Relief ANGELICA ARCHANGELICA ROOT SALVIA OFFICINALIS LEAF HYOSCYAMUS NIGER SILVER NITRATE PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ANGELICA ARCHANGELICA ROOT; HYOSCYAMUS NIGER; SALVIA OFFICINALIS LEAF; SILVER NITRATE 3; 7; 3; 15 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8106_0063aa03-2afa-4bfd-87f8-4fc2dde3e316 48951-8106 HUMAN OTC DRUG Quartz 20 Special Order Quartz 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 20 [hp_X]/mL 48951-8108_c700bf48-4337-4858-93b7-9630507a1167 48951-8108 HUMAN OTC DRUG Quartz 30 Quartz 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 30 [hp_X]/mL 48951-8109_6cb9082a-ad24-474b-ad1b-1a1ae88e394f 48951-8109 HUMAN OTC DRUG Quartz 8 Quartz 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 8 [hp_X]/mL 48951-8110_8081d163-89c4-4c68-8f65-a5d71fc91e72 48951-8110 HUMAN OTC DRUG Quartz Nicotiana Special Order Quartz Nicotiana Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; HAMAMELIS VIRGINIANA LEAF; HORSE CHESTNUT; TOBACCO LEAF 10; 3; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8111_5d81efb2-ca1f-4b24-8f08-47683526f875 48951-8111 HUMAN OTC DRUG Quartz Oxalis Nicotiana Quartz Oxalis Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; OXALIS MONTANA LEAF; SILVER; TOBACCO LEAF 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8113_335ef225-0f5c-4fe2-9640-c300c29a84aa 48951-8113 HUMAN OTC DRUG Quercus 5 Quercus 5 OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. QUERCUS ROBUR WHOLE 1 [hp_X]/g 48951-8115_e1a09c65-d45c-4407-a031-761476033998 48951-8115 HUMAN OTC DRUG Quercus Borago Adult Size Quercus Borago Adult Size SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AESCULUS HIPPOCASTANUM BARK; ANTIMONY; BORAGE; HAMAMELIS VIRGINIANA LEAF; MERCURIALIS PERENNIS; MILK THISTLE; QUERCUS ROBUR WHOLE 3; 3; 3; 3; 2; 3; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-8116_e0412273-1f0a-43ee-a9d4-52a66f88876b 48951-8116 HUMAN OTC DRUG Quercus Borago Hemorrhoid Relief Quercus Borago Hemorrhoid Relief OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; BORAGE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; MERCURIALIS PERENNIS; MILK THISTLE; QUERCUS ROBUR WHOLE 3; 1; 1; 1; 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-8117_07b57bb5-177e-4bb4-ab1e-913effafd323 48951-8117 HUMAN OTC DRUG Quercus Cinis Quercus Cinis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. QUERCUS ROBUR WHOLE 5 [hp_X]/mL 48951-8118_d69a8f80-e671-11de-8a39-0800200c9a66 48951-8118 HUMAN OTC DRUG Quercus Cinis Food Allergy Relief WHITE OAK BARK PELLET ORAL 20091201 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc WHITE OAK BARK 5 [hp_X]/1 48951-8119_437ede4e-68e2-4aba-9eae-5d9e9ef5615a 48951-8119 HUMAN OTC DRUG Quercus Essence Quercus Essence LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. QUERCUS ROBUR WHOLE 1 [hp_X]/mL 48951-8121_44780b9e-7300-410b-a365-c9214c7f26ce 48951-8121 HUMAN OTC DRUG Rectum 6 Special Order Rectum 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA RECTUM 6 [hp_X]/mL 48951-8124_375f468b-b6cc-4d8a-8c61-99eb3633247b 48951-8124 HUMAN OTC DRUG Renes Argentum nitricum Renes Argentum nitricum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PORK KIDNEY; SILVER 17; 20 [hp_X]/mL; [hp_X]/mL 48951-8125_ec21ca72-c73b-416f-a50c-30da2823412a 48951-8125 HUMAN OTC DRUG Renes Betula Renes Betula LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARCTOSTAPHYLOS UVA-URSI LEAF; BETULA PUBESCENS LEAF; CAPSELLA BURSA-PASTORIS; COPPER; CYTISUS SCOPARIUS FLOWERING TOP; ELYMUS REPENS TOP; EQUISETUM ARVENSE TOP; ONONIS REPENS ROOT; PARSLEY; PORK KIDNEY; SOLIDAGO VIRGAUREA FLOWERING TOP 2; 3; 2; 8; 3; 2; 3; 2; 2; 3; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8126_f18fa966-f883-4e0a-abe3-a23f6914692d 48951-8126 HUMAN OTC DRUG Renes Carbo Renes Carbo LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL; PORK KIDNEY 20; 6 [hp_X]/mL; [hp_X]/mL 48951-8127_b186d21a-3a1d-4c25-a84d-82e7d076b1bd 48951-8127 HUMAN OTC DRUG Renes Cuprum Renes Cuprum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND; COPPER; PORK KIDNEY 6; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8128_3b451f3c-1d57-4bd1-91ad-789e171eb2b7 48951-8128 HUMAN OTC DRUG Renes Cuprum Special Order Renes Cuprum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER; PORK KIDNEY 8; 6 [hp_X]/mL; [hp_X]/mL 48951-8129_9b90230b-743d-41cf-be85-e6d01d37fa27 48951-8129 HUMAN OTC DRUG Renes Cuprum Renes Cuprum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND; COPPER; PORK KIDNEY 6; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8130_f888efc2-8e2a-424e-8d27-3f68df9b98e7 48951-8130 HUMAN OTC DRUG Renes Mesenchyme Renes Mesenchyme LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BORAGE; BOS TAURUS CARTILAGE; BOS TAURUS CONJUNCTIVA; BOS TAURUS LYMPH VESSEL; CUPRIC ACETATE; PORK KIDNEY; SUS SCROFA UMBILICAL CORD; VISCUM ALBUM FRUITING TOP 6; 8; 8; 8; 6; 8; 8; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8131_b4346dfe-473c-4c40-a5a3-df6ee6352e9d 48951-8131 HUMAN OTC DRUG Renes Mesenchyme Renes Mesenchyme LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BORAGE; BOS TAURUS CARTILAGE; BOS TAURUS CONJUNCTIVA; BOS TAURUS LYMPH VESSEL; CUPRIC ACETATE; PORK KIDNEY; SUS SCROFA UMBILICAL CORD; VISCUM ALBUM FRUITING TOP 6; 8; 8; 8; 6; 8; 8; 15 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8132_1a96d9fa-7f65-41db-b133-3d639d750c62 48951-8132 HUMAN OTC DRUG Renes Veratrum Renes Veratrum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; EQUISETUM ARVENSE TOP; PORK KIDNEY; VERATRUM ALBUM ROOT; VISCUM ALBUM FRUITING TOP 30; 20; 7; 6; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8133_729d0f13-d973-4fc9-87bb-62b99108195f 48951-8133 HUMAN OTC DRUG Renes Veratrum Renes Veratrum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; EQUISETUM ARVENSE TOP; PORK KIDNEY; VERATRUM ALBUM ROOT; VISCUM ALBUM FRUITING TOP 30; 20; 7; 6; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8135_6a3591bf-2728-40e9-bfb4-cc0b3fd51fc5 48951-8135 HUMAN OTC DRUG Reticuloendothelial system 8 Special Order Reticuloendothelial system 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF LIVER 8 [hp_X]/mL 48951-8139_f4f8ea7a-2f65-45df-81f7-2007623b53cc 48951-8139 HUMAN OTC DRUG Rheuma Joint Support Rheuma Joint Support OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA FLOWER; COMFREY ROOT; ONION 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-8140_7264effe-72d8-4f47-9514-fbeb4d08c862 48951-8140 HUMAN OTC DRUG Rhus Aconitum Rhus Aconitum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; MANDRAGORA OFFICINARUM ROOT; PENOXSULAM; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; TOXICODENDRON PUBESCENS LEAF 6; 6; 4; 6; 10; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8142_28540bdb-3367-4db2-a7e8-975a19bbca20 48951-8142 HUMAN OTC DRUG Rhus Aconitum Rhus Aconitum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; MANDRAGORA OFFICINARUM ROOT; PENOXSULAM; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; TOXICODENDRON PUBESCENS LEAF 4; 6; 3; 4; 10; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8143_3d2c57ba-2d89-4a3f-93e1-1560e7285ab3 48951-8143 HUMAN OTC DRUG Rhus Tox. e fol. 4 Rhus Tox. e fol. 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TOXICODENDRON PUBESCENS LEAF 4 [hp_X]/mL 48951-8144_8e309991-5a1b-44bd-a422-de687728f97b 48951-8144 HUMAN OTC DRUG Robinia Nicotiana Robinia Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND; COPPER; ROBINIA PSEUDOACACIA BARK; SILVER; SODIUM PHOSPHATE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 6; 8; 4; 6; 10; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8145_dabda781-4afc-4919-b4fa-d3f2182d0460 48951-8145 HUMAN OTC DRUG Robinia Nicotiana Robina Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND; COPPER; ROBINIA PSEUDOACACIA BARK; SILVER; SODIUM PHOSPHATE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 6; 8; 4; 6; 10; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8146_febb3b19-3357-40f5-b6c1-8dcfcb836fea 48951-8146 HUMAN OTC DRUG Robinia Nicotiana Robinia Nicotiana PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER; ROBINIA PSEUDOACACIA BARK; SILVER; SODIUM PHOSPHATE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; TOBACCO LEAF 8; 4; 6; 10; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8148_930a094f-9e92-43e8-bedb-763c3bb956af 48951-8148 HUMAN OTC DRUG Rose Copper Warming Support Rose Copper Warming Support OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC CATION 1 [hp_X]/g 48951-8149_cd31f860-3a39-45de-8ea8-7037cc8b6d7e 48951-8149 HUMAN OTC DRUG Rose Iron Graphite Rose Iron Graphite LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERRIC OXIDE RED; GRAPHITE; SEDUM ROSEUM WHOLE 6; 17; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8150_eb36e5a9-ba3d-403b-8463-5fb0bee09c4d 48951-8150 HUMAN OTC DRUG Rose iron Graphite Rose iron Graphite PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERRIC OXIDE RED; GRAPHITE; SEDUM ROSEUM WHOLE 6; 17; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8151_7a0bcf4f-87cb-4778-927e-573f374b1d27 48951-8151 HUMAN OTC DRUG Rose Quartz Skin Protection Rose Quartz Skin Protection OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; KALANCHOE DAIGREMONTIANA LEAF 32; 2 [hp_X]/g; [hp_X]/g 48951-8154_ecc5a6b6-3823-48a1-94f0-4fe182cb14b7 48951-8154 HUMAN OTC DRUG Rosmarinus Argentum Rosmarinus Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMBER; ROSMARINUS OFFICINALIS FLOWERING TOP; SILVER; TARAXACUM OFFICINALE ROOT 6; 6; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8156_5aa1ec2e-8f96-49ab-99b7-f39d8b309946 48951-8156 HUMAN OTC DRUG Rosmarinus ex herba 3 Special Order Rosmarinus ex herba 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ROSMARINUS OFFICINALIS FLOWERING TOP 3 [hp_X]/mL 48951-8157_ff6d76b2-09d8-4c6e-86df-109a8b1183b1 48951-8157 HUMAN OTC DRUG Rosmarinus Lavandula Rosmarinus Lavandula GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF; BOS TAURUS PLACENTA; BOS TAURUS SOMATIC NERVE; OSTREA EDULIS SHELL; SUS SCROFA SKIN; SUS SCROFA UMBILICAL CORD; TIN 8; 8; 8; 8; 8; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-8158_7a38ce12-4a39-401e-94ba-0d79815b7abf 48951-8158 HUMAN OTC DRUG Rosmarinus Poterium Rosmarinus Poterium LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMBER; ROSEMARY OIL; ROSMARINUS OFFICINALIS FLOWERING TOP; SANGUISORBA OFFICINALIS ROOT; SILVER; TARAXACUM PALUSTRE ROOT 6; 6; 6; 2; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8159_9982a1af-fd2d-4029-8369-a6ee1fd9128d 48951-8159 HUMAN OTC DRUG Sabal Populus Sabal Populus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; MAGNESITE; POPULUS TREMULA WHOLE; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; THUJA OCCIDENTALIS WHOLE 3; 12; 3; 3; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8160_e829414c-bcba-4b1d-be56-afbf22b8c845 48951-8160 HUMAN OTC DRUG Sabadilla Eucalyptus Cold and Flu Relief Sabadilla Eucalyptus Cold and Flu Relief LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; PHOSPHORUS; SCHOENOCAULON OFFICINALE SEED 4; 3; 3; 3; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8161_6f5c448c-ae14-404e-ade8-b24efda6ec4a 48951-8161 HUMAN OTC DRUG Sabal Populus Sabal Populus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; MAGNESITE; POPULUS TREMULA WHOLE; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; THUJA OCCIDENTALIS WHOLE 3; 12; 3; 3; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8162_e35024da-9da2-45df-a006-2e7f05470b05 48951-8162 HUMAN OTC DRUG Sambucus Larix Sambucus Larix LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BLACK COHOSH; LARIX DECIDUA RESIN; SAMBUCUS NIGRA FLOWERING TOP 3; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8163_d49d7ae9-5d9d-4b7e-b629-66ad921bb206 48951-8163 HUMAN OTC DRUG Sambucus Larix Sambucus Larix PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BLACK COHOSH; LARIX DECIDUA RESIN; SAMBUCUS NIGRA FLOWERING TOP 3; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8164_cae663a2-865f-4d9a-89bf-2a3e36616383 48951-8164 HUMAN OTC DRUG Sarothamnus Aurum Special Order Sarothamnus Aurum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERYLLIUM; CAMPHOR (NATURAL); CYTISUS SCOPARIUS FLOWER; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; SELENICEREUS GRANDIFLORUS STEM 17; 4; 3; 17; 4; 3; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8165_3e64ffa7-fc94-4042-8346-1085771a6106 48951-8165 HUMAN OTC DRUG Sarothamnus Aurum Sarothamnus Aurum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERYLLIUM; CAMPHOR (NATURAL); CYTISUS SCOPARIUS FLOWER; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; SELENICEREUS GRANDIFLORUS STEM 17; 4; 3; 17; 4; 3; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8166_792bc757-6b73-47c8-badc-6ca001e5a76f 48951-8166 HUMAN OTC DRUG Scilla Crataegus Scilla Crataegus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ADONIS VERNALIS FLOWERING TOP; CONVALLARIA MAJALIS; DRIMIA MARITIMA BULB; HAWTHORN LEAF WITH FLOWER; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 3; 4; 4; 3; 4; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8167_7f832fd9-b51d-4c3d-b5c0-2d223152e407 48951-8167 HUMAN OTC DRUG Scilla Crataegus Scilla Crataegus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ADONIS VERNALIS FLOWERING TOP; CONVALLARIA MAJALIS; DRIMIA MARITIMA BULB; HAWTHORN LEAF WITH FLOWER; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER 3; 4; 4; 3; 4; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8168_f697ae53-3045-48fc-8675-ced5c3564dc1 48951-8168 HUMAN OTC DRUG Scorodite Prunus Scorodite Prunus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PITUITARY GLAND; CAMPHOR (NATURAL); FERROUS ARSENATE; GOLD; SLOE; VERATRUM ALBUM ROOT 8; 4; 6; 10; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8169_bd61e58b-3b73-4340-8409-5ca217371fc6 48951-8169 HUMAN OTC DRUG Scorodite Prunus Scorodite Prunus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PITUITARY GLAND; CAMPHOR (NATURAL); FERROUS ARSENATE; GOLD; SLOE; VERATRUM ALBUM ROOT 8; 4; 6; 10; 6; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8170_2a434c26-eeb0-41bd-8acc-7ef8c440bcca 48951-8170 HUMAN OTC DRUG Scorodite Saccharum Special Order Scorodite Saccharum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PARATHYROID GLAND; FERROUS ARSENATE; OXALIS MONTANA LEAF; SUGARCANE 6; 6; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8171_99f339e2-5ce3-4176-8e1e-09a6e96ef63f 48951-8171 HUMAN OTC DRUG Scorodite Saccharum Special Order Scorodite Saccharum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PARATHYROID GLAND; FERROUS ARSENATE; OXALIS MONTANA LEAF; SUGARCANE 6; 6; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8172_f5db73f1-de5b-4ef1-8021-94a1fcefba8f 48951-8172 HUMAN OTC DRUG Secale Argentum Special Order Secale Argentum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARISTOLOCHIA CLEMATITIS WHOLE; CLAVICEPS PURPUREA SCLEROTIUM; PULSATILLA VULGARIS; SILVER 3; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8173_251f6268-d213-4f79-98ab-790541f5005b 48951-8173 HUMAN OTC DRUG Secale Argentum Special Order Secale Argentum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARISTOLOCHIA CLEMATITIS WHOLE; CLAVICEPS PURPUREA SCLEROTIUM; GOLD; PULSATILLA VULGARIS 3; 6; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8174_ec5fa9fe-a321-4e86-b896-a273fc9d65c3 48951-8174 HUMAN OTC DRUG Secale Betula Special Order Secale Betula Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; BOS TAURUS EYE; CLAVICEPS PURPUREA SCLEROTIUM; LEAD SULFIDE; LEVISTICUM OFFICINALE ROOT; TOBACCO LEAF 12; 4; 3; 8; 6; 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8175_edcf38f1-7119-4ca7-abd8-33a2436256e6 48951-8175 HUMAN OTC DRUG Secale Betula Secale Betula PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; BOS TAURUS EYE; CLAVICEPS PURPUREA SCLEROTIUM; LEAD SULFIDE; LEVISTICUM OFFICINALE ROOT; TOBACCO LEAF 12; 4; 3; 8; 6; 8; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8176_ab6781a7-1d38-4684-8bf8-a495df713466 48951-8176 HUMAN OTC DRUG Secale Nicotiana Secale Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; BOS TAURUS ARTERY; CLAVICEPS PURPUREA SCLEROTIUM; LEAD SULFIDE; TOBACCO LEAF 4; 3; 8; 6; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8177_277925e5-87cc-4139-9dc3-b1a01ed24e4b 48951-8177 HUMAN OTC DRUG Secale Nicotiana Secale Nicotiana PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; BOS TAURUS ARTERY; CLAVICEPS PURPUREA SCLEROTIUM; LEAD SULFIDE; TOBACCO LEAF 4; 3; 8; 6; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8178_7321fccd-9cfe-494c-9545-5aca1c0760b3 48951-8178 HUMAN OTC DRUG Secale Quartz Secale Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CLAVICEPS PURPUREA SCLEROTIUM; COLLOIDAL SILICON DIOXIDE; SANGUINARIA CANADENSIS ROOT 6; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8180_620b6d9e-7ad5-4dfa-82fe-a0b5820570f3 48951-8180 HUMAN OTC DRUG Secale Quartz Secale Quartz PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CLAVICEPS PURPUREA SCLEROTIUM; COLLOIDAL SILICON DIOXIDE; SANGUINARIA CANADENSIS ROOT 6; 30; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8182_b8a246e2-1493-409a-a9ef-81cff84633f0 48951-8182 HUMAN OTC DRUG Silica 12 Special Order Silica 12 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 12 [hp_X]/1 48951-8183_18a6e33e-d03f-4f42-a667-a5b27611ae3f 48951-8183 HUMAN OTC DRUG Silica 20 Special Order Silica 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 20 [hp_X]/mL 48951-8185_8fadf063-0111-4dcb-9561-abf4c1a24cdd 48951-8185 HUMAN OTC DRUG Silica 8 Silica 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 8 [hp_X]/mL 48951-8186_1d739700-2dfb-11df-8a39-0800200c9a66 48951-8186 HUMAN OTC DRUG Silica Skin Support EQUISETUM ARVENSE TOP WHITE OAK BARK MAMMAL LIVER POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc EQUISETUM ARVENSE TOP; MAMMAL LIVER; WHITE OAK BARK 5; 9; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8187_0e7b8df1-776e-4ec6-bea4-423518798f22 48951-8187 HUMAN OTC DRUG Silicea Belladonna Silicea Belladonna LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; COLLOIDAL SILICON DIOXIDE; SILVER 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8189_943d4b8f-3b02-4a1a-8241-8a1ef7c79a43 48951-8189 HUMAN OTC DRUG Silicea Belladonna Silicea Belladonna PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; COLLOIDAL SILICON DIOXIDE; SILVER 20; 20; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8192_3c585142-8a56-45f6-8544-e0b987c419b6 48951-8192 HUMAN OTC DRUG Solanum lycopersicum 4 Solanum lycopersicum 4 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SOLANUM LYCOPERSICUM 4 [hp_X]/1 48951-8193_df580764-bee1-46d7-8b51-8e738375befa 48951-8193 HUMAN OTC DRUG Solum Aesculus Solum Aesculus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; HORSE CHESTNUT; SPHAGNUM SQUARROSUM PEAT; ST. JOHN'S WORT 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8197_0847104a-770d-481f-a1b2-5320f588a11d 48951-8197 HUMAN OTC DRUG Solum Aesculus Sensitivity Solum Aesculus Sensitivity PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; HORSE CHESTNUT; SPHAGNUM SQUARROSUM PEAT; ST. JOHN'S WORT 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8200_b2b32b1c-3165-49f1-8b11-c79dbce62263 48951-8200 HUMAN OTC DRUG Spongia Aurum Special Order Spongia Aurum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALCIUM CARBONATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILVER; SLOE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUGARCANE 12; 4; 6; 12; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8201_94c6af9a-84f5-4d3c-a472-916e5544af44 48951-8201 HUMAN OTC DRUG Spongia Aurum Spongia Aurum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALCIUM CARBONATE; GOLD; PRUNUS SPINOSA FLOWER BUD; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUGARCANE 12; 12; 6; 7; 7; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8203_a6b0151a-acb2-4db1-bd0c-b9c0389f7457 48951-8203 HUMAN OTC DRUG Spongia Ovi Spongia Ovi PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALCIUM CARBONATE; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE WHOLE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUGARCANE 6; 3; 3; 1; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8204_1b0afa56-585a-4aff-811a-d5713e7aa0e6 48951-8204 HUMAN OTC DRUG Stannum 10 Special Order Stannum 10 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TIN 10 [hp_X]/mL 48951-8206_42171d64-4dbf-4e8d-8e42-e163528f1b37 48951-8206 HUMAN OTC DRUG Stannum 5 Stannum 5 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TIN 5 [hp_X]/g 48951-8207_a0677870-a011-497d-b3d2-59c5bafd4443 48951-8207 HUMAN OTC DRUG Stannum 5 Stannum 5 OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TIN 1 [hp_X]/g 48951-8210_3222cb34-f5b8-4eeb-8936-72c0f83f91d5 48951-8210 HUMAN OTC DRUG Stannum 0.4 Stannum 0.4 OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TIN 1 [hp_X]/g 48951-8211_99063880-8cfa-48cd-9570-7df84ace1d39 48951-8211 HUMAN OTC DRUG Stibium 20 Stibium 20 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 20 [hp_X]/mL 48951-8212_e1f7c111-5365-4eab-980d-cc1bd4849cde 48951-8212 HUMAN OTC DRUG Stibium 5 Stibium 5 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 5 [hp_X]/g 48951-8213_729f049e-cc6e-4cc3-90c4-f633a86c1c91 48951-8213 HUMAN OTC DRUG Stibium 6 Stibium 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 6 [hp_X]/mL 48951-8214_27e8cf87-db1e-4944-a6a7-2d9d50cae22c 48951-8214 HUMAN OTC DRUG Stibium 6 Special Order Stibium 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 6 [hp_X]/mL 48951-8216_9cb970f7-3c70-4cb7-b578-36e1f4fb8c08 48951-8216 HUMAN OTC DRUG Strophanthus Aurum Strophanthus Aurum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; STROPHANTHUS KOMBE WHOLE 8; 10; 4; 3; 3; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8217_3b2f2cfd-7643-4fa8-b1d8-e44db3e6729e 48951-8217 HUMAN OTC DRUG Strophanthus Aurum Strophanthus Aurum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; STROPHANTHUS KOMBE WHOLE 8; 10; 4; 3; 3; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8218_6c9cca5f-502f-4804-9182-321ab1a7c8d6 48951-8218 HUMAN OTC DRUG Strophanthus Nicotiana Strophanthus Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HONEY; LEAD; STROPHANTHUS HISPIDUS SEED; TOBACCO LEAF 30; 30; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8219_6f71b3cd-062c-4006-aed6-9654370494ff 48951-8219 HUMAN OTC DRUG Strophanthus Nicotiana Strophanthus Nicotiana PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HONEY; LEAD; STROPHANTHUS HISPIDUS SEED; TOBACCO LEAF 15; 15; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8220_5b8b705c-aebe-429a-a706-1a576f55bece 48951-8220 HUMAN OTC DRUG Sulfur 30 Special Order Sulfur 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SULFUR 30 [hp_X]/mL 48951-8221_c58c9e5e-305b-4fdc-ab48-86c275b846e4 48951-8221 HUMAN OTC DRUG Sulfur 6 Sulfur 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SULFUR 6 [hp_X]/mL 48951-8222_48caf225-aaae-4a4d-a165-6dc088063838 48951-8222 HUMAN OTC DRUG Symphytum Hamamelis Symphytum Hamamelis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; HAMAMELIS VIRGINIANA TOP; ONION; RUTA GRAVEOLENS FLOWERING TOP 4; 4; 3; 2; 3; 4; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8223_54dbf0f3-0579-415b-a84c-42683fda23b4 48951-8223 HUMAN OTC DRUG Symphytum Stannum Symphytum Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; COMFREY ROOT; ONION; TIN 3; 3; 3; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8224_cb4d95b9-371c-4fc8-bf6c-23f385de231c 48951-8224 HUMAN OTC DRUG Symphytum Stannum Bone Support Symphytum Stannum Bone Support PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; COMFREY ROOT; ONION; TIN 3; 3; 3; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8225_ce33d78c-e230-4557-8e9e-e7c78812b500 48951-8225 HUMAN OTC DRUG Stibium 0.4 Stibium 0.4 OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 1 [hp_X]/g 48951-8226_e6b1fd85-24c8-47ac-bc9d-5d5480fecbe3 48951-8226 HUMAN OTC DRUG Sepia comp. Sepia comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OSTREA EDULIS SHELL; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED 8; 5; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8229_816bf22c-97cb-4489-ba1b-424407029ae6 48951-8229 HUMAN OTC DRUG Pulmo Mercurius Special Order Pulmo Mercurius Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY; SUS SCROFA LUNG 17; 8 [hp_X]/mL; [hp_X]/mL 48951-8230_47008dd9-99b9-4879-a39d-1dc7cfe59653 48951-8230 HUMAN OTC DRUG Stibium 20 Special Order Stibium 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 20 [hp_X]/mL 48951-8231_644fb606-fd15-46ef-aa6f-faeffa841595 48951-8231 HUMAN OTC DRUG Silica 30 Special Order Silica 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 30 [hp_X]/mL 48951-8232_ce979ee1-b0ed-49dc-9aed-45940cd41152 48951-8232 HUMAN OTC DRUG Regio substantiae nigrae 6 Special Order Regio substantiae nigrae 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BRAIN 6 [hp_X]/mL 48951-8233_354e8ec7-2d33-4e14-b84c-5bbec04ad321 48951-8233 HUMAN OTC DRUG Rosmarinus Lavendula Special Order Rosmarinus Lavendula Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF; BOS TAURUS OVARY; BOS TAURUS PLACENTA; CUPRIC OXIDE; FERRIC OXIDE RED; LAVANDULA ANGUSTIFOLIA FLOWER; OSTREA EDULIS SHELL; ROSMARINUS OFFICINALIS FLOWERING TOP; SEDUM ROSEUM WHOLE; SLOE; SUS SCROFA SKIN; TIN; URTICA DIOICA 6; 15; 15; 10; 10; 10; 10; 10; 10; 5; 12; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-8234_345d3f4a-8d33-4fa0-b6ae-d55e4301d799 48951-8234 HUMAN OTC DRUG Periodontium Quartz Special Order Periodontium Quartz Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; BEEF TONGUE; BOS TAURUS BONE; CALENDULA OFFICINALIS FLOWERING TOP; COLLOIDAL SILICON DIOXIDE; SILVER; SUS SCROFA TOOTH 17; 17; 17; 3; 30; 20; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8235_2ca7a737-02a4-47b0-8ead-62de93be3351 48951-8235 HUMAN OTC DRUG Renes Betula Special Order Renes Betula Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARCTOSTAPHYLOS UVA-URSI LEAF; BETULA PUBESCENS LEAF; CAPSELLA BURSA-PASTORIS; COPPER; CYTISUS SCOPARIUS FLOWERING TOP; ELYMUS REPENS TOP; EQUISETUM ARVENSE TOP; ONONIS REPENS ROOT; PARSLEY; PORK KIDNEY; SOLIDAGO VIRGAUREA FLOWERING TOP 3; 4; 3; 9; 4; 3; 4; 3; 3; 4; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8236_78beacca-ec97-4ede-a034-f0998aaf7603 48951-8236 HUMAN OTC DRUG Renes Carbo Special Order Renes Carbo Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL; PORK KIDNEY 20; 6 [hp_X]/1; [hp_X]/1 48951-8237_8aa86a90-ed30-478f-8f3a-0622aa3375fc 48951-8237 HUMAN OTC DRUG Reticuloendothelial system 8 Special Order Reticuloendothelial system 8 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF LIVER 8 [hp_X]/1 48951-8238_421a06cb-faa3-4466-962a-99cf9c381432 48951-8238 HUMAN OTC DRUG Pancreas Meteoric Iron Special Order Pancreas Meteoric Iron Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON; ROSMARINUS OFFICINALIS FLOWERING TOP; SUS SCROFA PANCREAS 20; 4; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8239_d745e31f-833e-463e-af55-2330930c83ac 48951-8239 HUMAN OTC DRUG Mandragora Arnica Special Order Mandragora Arnica Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BETULA PUBESCENS LEAF; EQUISETUM ARVENSE TOP; FORMICA RUFA; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA MENISCUS 15; 3; 15; 10; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8240_b6e704ce-8652-40da-ad8a-50a48b02285a 48951-8240 HUMAN OTC DRUG Quartz Nicotiana Special Order Quartz Nicotiana Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; HAMAMELIS VIRGINIANA LEAF; HORSE CHESTNUT; TOBACCO LEAF 10; 3; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8241_4d87acbc-3238-4e50-8a67-f0fe0166d2ed 48951-8241 HUMAN OTC DRUG Quartz 60 Special Order Quartz 60 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 60 [hp_X]/mL 48951-8242_01b1418f-d06c-410c-8761-431d284f6adf 48951-8242 HUMAN OTC DRUG Rhus tox. 1 Special Order Rhus tox. 1 Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TOXICODENDRON PUBESCENS LEAF 2 [hp_X]/g 48951-8243_90e45266-3110-4572-b42d-b220069491e1 48951-8243 HUMAN OTC DRUG Stannum 17 Special Order Stannum 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TIN 17 [hp_X]/mL 48951-8245_31177374-4326-446e-b67b-104f28c01f54 48951-8245 HUMAN OTC DRUG Pulmo Mercurius Special Order Pulmo Mercurius Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY; SUS SCROFA LUNG 17; 8 [hp_X]/1; [hp_X]/1 48951-8246_15dccd61-8427-4c5e-a8ee-d2857f1c9574 48951-8246 HUMAN OTC DRUG Sulfur 6 Special Order Sulfur 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SULFUR 6 [hp_X]/mL 48951-8247_2a918f39-1caa-4728-8af4-fb24ff4c1eab 48951-8247 HUMAN OTC DRUG Periosteum 8 Special Order Periosteum 8 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BONE 8 [hp_X]/1 48951-8248_71b5f928-03f0-4554-a26e-745bb0950671 48951-8248 HUMAN OTC DRUG Sulfur 30 Special Order Sulfur 30 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SULFUR 30 [hp_X]/1 48951-8249_d239666b-a1a3-4155-b5ac-6c40711ba5da 48951-8249 HUMAN OTC DRUG Rhus Aconitum Special Order Rhus Aconitum Special Order GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; EQUISETUM ARVENSE TOP; GOLD; HORSE CHESTNUT; SLOE; TOXICODENDRON PUBESCENS LEAF; URTICA DIOICA LEAF 5; 5; 5; 3; 10; 3; 5; 5; 5 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-8250_d83888f6-b280-4a62-a697-c7baba045e57 48951-8250 HUMAN OTC DRUG Strophanthus Aurum Special Order Strophanthus Aurum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; GOLD; HYOSCYAMUS NIGER LEAF; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; STROPHANTHUS KOMBE WHOLE 8; 10; 4; 3; 3; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8251_a42bc0e0-b2e7-44a7-8650-772b78959b9b 48951-8251 HUMAN OTC DRUG Phosphorus comp. Special Order Phosphorus comp. Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMBER; COLLOIDAL SILICON DIOXIDE; CUPRIC SULFATE; PHOSPHORUS; ROSMARINUS OFFICINALIS FLOWERING TOP; SILVER; SUS SCROFA PANCREAS 6; 12; 4; 6; 6; 30; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8252_94cf080f-0e3c-4e89-b8cc-e775d99bb49e 48951-8252 HUMAN OTC DRUG Passiflora Crataegus Special Order Passiflora Crataegus Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAWTHORN LEAF WITH FLOWER; KALANCHOE DAIGREMONTIANA LEAF; PASSIFLORA INCARNATA FLOWERING TOP; SALIX ALBA FLOWER 3; 2; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8253_f6f3e70c-ffc6-449c-8420-edbe67bd0411 48951-8253 HUMAN OTC DRUG Prunus spinosa e summ. 30 Special Order Prunus spinosa e summ. 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE 1 [hp_X]/mL 48951-8254_fb147dc5-c58c-4f22-8eee-d485cbfe820e 48951-8254 HUMAN OTC DRUG Plantago Primula Special Order Plantago Primula Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HYOSCYAMUS NIGER LEAF; PLANTAGO MAJOR LEAF; PRIMULA VERIS FLOWER 4; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8255_39c28a68-3aaf-4853-b9e4-7837383d3014 48951-8255 HUMAN OTC DRUG Prunus spinosa e fruct. 3 Special Order Prunus spinosa e fruct. 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE 3 [hp_X]/mL 48951-8256_ba065041-db92-4eb4-8de2-878507b85738 48951-8256 HUMAN OTC DRUG Phosphorus Coffea Special Order Phosphorus Coffea Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COFFEA ARABICA SEED, ROASTED; GOLD; KALANCHOE DAIGREMONTIANA LEAF; OSTREA EDULIS SHELL; PHOSPHORUS; SILVER; SULFUR; VALERIAN 60; 30; 5; 30; 25; 20; 25; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8257_3546dc87-14c5-4ee0-b5e2-854e36d811e9 48951-8257 HUMAN OTC DRUG Phytolacca e rad 6 Special Order Phytolacca e rad 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PHYTOLACCA AMERICANA ROOT 6 [hp_X]/mL 48951-8258_c785b3a7-8615-4445-8b8b-179ece20f27f 48951-8258 HUMAN OTC DRUG Pulsatilla e flor. 30 Special Order Pulsatilla e flor. 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PULSATILLA VULGARIS 30 [hp_X]/mL 48951-8259_7e88850f-8a15-45df-9c76-03c8f381ba65 48951-8259 HUMAN OTC DRUG Pulsatilla e flor. 6 Special Order Pulsatilla e flor. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PULSATILLA VULGARIS 6 [hp_X]/mL 48951-8260_e577b61e-ee56-47ee-a3a7-94cfb81baf31 48951-8260 HUMAN OTC DRUG Rosmarinus Formica Special Order Rosmarinus Formica Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA ROOT; BOS TAURUS SOMATIC NERVE; COLLOIDAL SILICON DIOXIDE; FORMICA RUFA; ROSMARINUS OFFICINALIS FLOWERING TOP; SILVER; STACHYS OFFICINALIS; TIN 20; 6; 12; 7; 6; 20; 6; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8261_f43c5aab-451c-4d51-89c3-a0d98c79b0ea 48951-8261 HUMAN OTC DRUG Pharynx 8 Special Order Pharynx 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ESOPHAGUS 8 [hp_X]/mL 48951-8262_d196d6d6-986c-4ba4-8490-9805e9508a58 48951-8262 HUMAN OTC DRUG Renes 5 Special Order Renes 5 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PORK KIDNEY 5 [hp_X]/mL 48951-8263_cac29191-86d4-4120-9478-b2691aef2d18 48951-8263 HUMAN OTC DRUG Renes Pulmo 8/8/12 Special Order Renes Pulmo 8/8/12 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PORK KIDNEY; SUS SCROFA LUNG 8; 8 [hp_X]/mL; [hp_X]/mL 48951-8265_d67ab06f-03d1-44ea-8bd3-4f34e10eef79 48951-8265 HUMAN OTC DRUG Rhus Aconitum Special Order Rhus Aconitum Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; MANDRAGORA OFFICINARUM ROOT; PENOXSULAM; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; TOXICODENDRON PUBESCENS LEAF 6; 6; 4; 6; 10; 4; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-8266_899e065a-3356-4de9-bf57-923fcd154575 48951-8266 HUMAN OTC DRUG Plantago e fol. 4 Special Order Plantago e fol. 4 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PLANTAGO MAJOR LEAF 4 [hp_X]/mL 48951-8268_d75a305b-d951-49a2-a183-80903650cf1f 48951-8268 HUMAN OTC DRUG Stannum mellitum 20 Special Order Stannum mellitum 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HONEY; TIN 20; 20 [hp_X]/mL; [hp_X]/mL 48951-8269_f7fdbfe1-983d-491f-91f0-917831e209c9 48951-8269 HUMAN OTC DRUG Periodontium Quartz Special Order Periodontium Quartz Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; BEEF TONGUE; BOS TAURUS BONE; CALENDULA OFFICINALIS FLOWERING TOP; COLLOIDAL SILICON DIOXIDE; SILVER; SUS SCROFA TOOTH 17; 17; 17; 3; 30; 20; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8270_1006ec73-0162-4e9c-af40-5e4b31d15152 48951-8270 HUMAN OTC DRUG Polygonatum Apis Special Order Polygonatum Apis Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BARIUM CITRATE; BOS TAURUS CARTILAGE; BOS TAURUS PLACENTA; BOS TAURUS TESTICLE; COLLOIDAL SILICON DIOXIDE; COPPER; ECHINACEA ANGUSTIFOLIA; GOLD; GRAPHITE; HIRUDIN; ONION; POLYGONATUM CYRTONEMA ROOT; ROYAL JELLY; SILVER; SUS SCROFA SKIN; THUJA OCCIDENTALIS WHOLE; VESPA CRABRO 14; 10; 10; 10; 10; 10; 6; 10; 19; 6; 6; 8; 6; 6; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8272_107df484-4e2c-4aa4-ae3f-cb29c466f189 48951-8272 HUMAN OTC DRUG Quartz Oxalis Nicotiana Special Order Quartz Oxalis Nicotiana Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; COPPER; HAMAMELIS VIRGINIANA LEAF; HORSE CHESTNUT; TIN; TOBACCO LEAF 10; 3; 3; 3; 3; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-8273_ddc49f1c-eaf2-4543-a7f9-039f96167691 48951-8273 HUMAN OTC DRUG Sepia comp Special Order Sepia comp Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OSTREA EDULIS SHELL; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED 8; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-8274_341db6bd-4319-489b-9322-53919a16803a 48951-8274 HUMAN OTC DRUG Solum Aesculus Essence Special Order Solum Aesculus Essence Special Order LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; HORSE CHESTNUT; ST. JOHN'S WORT 2; 2; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8275_3cad4a2a-ff02-4d8e-903b-e156ef01d289 48951-8275 HUMAN OTC DRUG Plumbum mellitum 30 Special Order Plumbum mellitum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HONEY; LEAD 30; 30 [hp_X]/mL; [hp_X]/mL 48951-8276_dbfa0c6c-0f57-4d85-b34f-134c7bf8e7cc 48951-8276 HUMAN OTC DRUG Plantain Beeswax Cough Relief Special Order Plantain Beeswax Cough Relief Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DROSERA ROTUNDIFOLIA; LARIX DECIDUA RESIN; PETASITES HYBRIDUS ROOT; PLANTAGO MAJOR LEAF; SAGE 6; 6; 6; 6; 5 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-8277_50c80ab8-d040-482d-8e95-0c304911e98e 48951-8277 HUMAN OTC DRUG Silica 30 Special Order Silica 30 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 30 [hp_X]/g 48951-8278_febbef32-2e48-42ef-8442-cae2976d59a4 48951-8278 HUMAN OTC DRUG Rhus tox. e fol. 30 Special Order Rhus tox. e fol. 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TOXICODENDRON PUBESCENS LEAF 30 [hp_X]/mL 48951-8279_44bc5ec7-0a1e-45fa-9aea-c2da03de728d 48951-8279 HUMAN OTC DRUG Stibium 30 Special Order Stibium 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 30 [hp_X]/mL 48951-8280_00ccd518-b1e3-4bfa-8d0f-4325744c8e4b 48951-8280 HUMAN OTC DRUG Symphytum Stannum Special Order Symphytum Stannum Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; COMFREY ROOT; ONION; TIN 3; 3; 3; 17 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-8282_5793a1c7-e1e9-4de8-8602-4e1dff760644 48951-8282 HUMAN OTC DRUG Stannum 8 Special Order Stannum 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TIN 8 [hp_X]/mL 48951-8283_73e296c4-fd2c-4d46-8fef-3ad0cfda2a72 48951-8283 HUMAN OTC DRUG Piper nigrum e fruct. 6 Special Order Piper nigrum e fruct. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BLACK PEPPER 6 [hp_X]/mL 48951-8284_34e6a7b1-b2c1-413e-97de-f04f4cbc2d52 48951-8284 HUMAN OTC DRUG Renes Mesenchyme Special Order Renes Mesenchyme Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BORAGE; BOS TAURUS CARTILAGE; BOS TAURUS CONJUNCTIVA; BOS TAURUS LYMPH VESSEL; CUPRIC ACETATE; PORK KIDNEY; SUS SCROFA UMBILICAL CORD; VISCUM ALBUM FRUITING TOP 6; 8; 8; 8; 6; 8; 8; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8285_d521e249-072b-4f58-a628-bb34052660af 48951-8285 HUMAN OTC DRUG Silicea Belladonna Special Order Silicea Belladonna Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; COLLOIDAL SILICON DIOXIDE; SILVER 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8286_f73a9661-bd40-49af-adac-7b5ac32d0264 48951-8286 HUMAN OTC DRUG Stannum 30 Special Order Stannum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TIN 30 [hp_X]/mL 48951-8287_695d152f-3e5f-4c73-be20-726eb1043908 48951-8287 HUMAN OTC DRUG Stibium 6 Special Order Stibium 6 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 6 [hp_X]/g 48951-8288_cf5bc938-5f9a-446d-b971-317639c9777f 48951-8288 HUMAN OTC DRUG Prunus spinosa e flor. et summ. 2 Special Order Prunus spinosa e flor. et summ. 2 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE 2 [hp_X]/1 48951-8289_d88903bd-540a-4297-83d9-0694b18273eb 48951-8289 HUMAN OTC DRUG Secale Nicotiana Special Order Secale Nicotiana Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; BOS TAURUS ARTERY; CLAVICEPS PURPUREA SCLEROTIUM; LEAD SULFIDE; TOBACCO LEAF 4; 3; 8; 6; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-8292_c3f079e6-1e6c-429e-a994-439709ad1484 48951-8292 HUMAN OTC DRUG Stibium 0.4 Adult Size Special Order Stibium 0.4 Adult Size Special Order SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 3 [hp_X]/g 48951-8293_e62111f9-978f-4900-8c7d-b730460db64a 48951-8293 HUMAN OTC DRUG Quartz Oxalis Nicotiana Special Order Quartz Oxalis Nicotiana Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; OXALIS MONTANA LEAF; SILVER; TOBACCO LEAF 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-9000_a3191b8e-22fe-43c9-b2c2-086c1935ee98 48951-9000 HUMAN OTC DRUG Taraxacum e pl tota 1 Special Order Taraxacum e pl tota 1 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TARAXACUM PALUSTRE ROOT 2 [hp_X]/mL 48951-9001_11a68347-b4bb-43ca-ba5c-62ec709c144f 48951-9001 HUMAN OTC DRUG Testes Apis Testes Apis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS TESTICLE; ROYAL JELLY; SILVER 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9002_7674076c-1b1c-41a5-baf2-f7f15b66b8ae 48951-9002 HUMAN OTC DRUG Testes Apis Testes Apis PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BOS TAURUS TESTICLE; SILVER 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-9004_0495e833-2c48-476c-a996-15c14631a26e 48951-9004 HUMAN OTC DRUG Thuja e summ. 6 Special Order Thuja e summ. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THUJA OCCIDENTALIS WHOLE 6 [hp_X]/mL 48951-9005_f346bfd8-6048-4bba-a203-f9859a5cdf91 48951-9005 HUMAN OTC DRUG Thuja Thymus comp. Thuja Thymus comp. PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMANITA MUSCARIA FRUITING BODY; ASPLENIUM SCOLOPENDRIUM TOP; BOS TAURUS THYMUS; COLLOIDAL SILICON DIOXIDE; DRYOPTERIS FILIX-MAS ROOT; EQUISETUM ARVENSE TOP; FORMICA RUFA; LEVISTICUM OFFICINALE ROOT; MAMMAL LIVER; MERCURY; OSTREA EDULIS SHELL; PORK KIDNEY; PTERIDIUM AQUILINUM WHOLE; SILVER; SLOE; THUJA OCCIDENTALIS WHOLE; URTICA DIOICA 7; 3; 4; 12; 3; 2; 3; 2; 4; 14; 5; 6; 3; 6; 2; 6; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-9006_5ecb1644-e224-41b9-8b0c-96d6572ee47a 48951-9006 HUMAN OTC DRUG Thuja Thymus comp. Thuja Thymus comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ASPLENIUM SCOLOPENDRIUM TOP; BOS TAURUS THYMUS; COLLOIDAL SILICON DIOXIDE; DRYOPTERIS FILIX-MAS ROOT; EQUISETUM ARVENSE TOP; FORMICA RUFA; LEVISTICUM OFFICINALE ROOT; MAMMAL LIVER; MERCURY; OSTREA EDULIS SHELL; PORK KIDNEY; PTERIDIUM AQUILINUM WHOLE; SILVER; SLOE; THUJA OCCIDENTALIS WHOLE; URTICA DIOICA 7; 3; 4; 12; 3; 2; 3; 2; 4; 14; 5; 6; 3; 6; 2; 6; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9008_dc32813e-da0f-4333-b6ae-5eb56b6176fa 48951-9008 HUMAN OTC DRUG Thymus Mercurius Thymus Mercurius LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS THYMUS; MERCURY 8; 20 [hp_X]/mL; [hp_X]/mL 48951-9009_6a130257-7291-4bf6-aa3d-d6ddf13772b9 48951-9009 HUMAN OTC DRUG Thymus Mercurius Thymus Mercurius PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS THYMUS; MERCURY 8; 20 [hp_X]/1; [hp_X]/1 48951-9010_6ed00320-e9ea-460e-b912-8c0241025d66 48951-9010 HUMAN OTC DRUG Thyreoidea Belladonna Thyreoidea Belladonna LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; CUPRIC SULFATE; OSTREA EDULIS SHELL; THYROID, UNSPECIFIED 30; 15; 6; 7; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9011_36d84b06-79f8-4795-82e1-5f7dcdb9a9c4 48951-9011 HUMAN OTC DRUG Thyreoidea Belladonna Thyreoidea Belladonna PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; CUPRIC SULFATE; OSTREA EDULIS SHELL; THYROID, UNSPECIFIED 30; 15; 6; 7; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-9012_6c7536d1-0840-459d-bfbd-ff5a1e971a95 48951-9012 HUMAN OTC DRUG Thyreoidea Ferrum Thyreoidea Ferrum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON; THYROID, UNSPECIFIED 12; 6 [hp_X]/mL; [hp_X]/mL 48951-9013_4892aeab-1fff-4346-b772-048e87f54ac6 48951-9013 HUMAN OTC DRUG Thyreoidea Ferrum Thyreoidea Ferrum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON; THYROID, UNSPECIFIED 12; 6 [hp_X]/1; [hp_X]/1 48951-9014_e6172647-3051-42e9-b3a2-05c0c9819dbd 48951-9014 HUMAN OTC DRUG Thyreoidea Melissa Thyreoidea Melissa LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARSENIC TRIOXIDE; BOS TAURUS PITUITARY GLAND; BOS TAURUS THYMUS; CUPRIC SULFATE; FUCUS VESICULOSUS; LYCOPUS VIRGINICUS; MELISSA OFFICINALIS; THYROID, UNSPECIFIED; VESPA CRABRO 6; 20; 5; 6; 3; 3; 3; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9015_37dc1fab-1ab9-4151-a543-328d13d16ea8 48951-9015 HUMAN OTC DRUG Thyreoidea Melissa Thyreoidea Melissa PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARSENIC TRIOXIDE; BOS TAURUS PITUITARY GLAND; BOS TAURUS THYMUS; CUPRIC SULFATE; FUCUS VESICULOSUS; LYCOPUS VIRGINICUS; MELISSA OFFICINALIS; THYROID, UNSPECIFIED; VESPA CRABRO 6; 20; 5; 6; 3; 3; 3; 30; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-9016_49d9e884-5ade-4e88-8433-863407f81f64 48951-9016 HUMAN OTC DRUG Tormentilla Cochlearia Tormentilla Cochlearia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; COCHLEARIA OFFICINALIS FLOWERING TOP; POTENTILLA ERECTA ROOT 6; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9017_a5c47970-e34c-11de-8a39-0800200c9a66 48951-9017 HUMAN OTC DRUG Tormentilla Cochlearia Menstrual Support HORSERADISH ACHILLEA MILLEFOLIUM ANTIMONY PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ACHILLEA MILLEFOLIUM; ANTIMONY; HORSERADISH 3; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-9019_3ea2dd20-e4e8-11de-8a39-0800200c9a66 48951-9019 HUMAN OTC DRUG Travel Remedy PRIMULA VERIS EXTRACT ONOPORDUM HYOSCYAMUS NIGER ANTIMONY GOLD ARNICA MONTANA BELLIS PERENNIS MATRICARIA RECUTITA IPECAC LYCOPODIUM CLAVATUM SPORE PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ANTIMONY; ARNICA MONTANA; BELLIS PERENNIS; GOLD; HYOSCYAMUS NIGER; IPECAC; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; ONOPORDUM; PRIMULA VERIS EXTRACT 8; 30; 30; 10; 4; 30; 30; 30; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-9020_cd47d140-081e-4af3-ae38-975c306f11aa 48951-9020 HUMAN OTC DRUG Triticum Cerebri Triticum Cerebri LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BRAINSTEM; WHEAT SPROUT 8; 20 [hp_X]/mL; [hp_X]/mL 48951-9021_e3306791-2ee5-48b7-9d79-0825584c059f 48951-9021 HUMAN OTC DRUG Triticum Cerebri Triticum Cerebri PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BRAINSTEM; WHEAT 8; 6 [hp_X]/1; [hp_X]/1 48951-9026_67421853-a2a1-47bf-9ebb-3815c80ed328 48951-9026 HUMAN OTC DRUG Urtica Conchae Special Order Urtica Conchae Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OSTREA EDULIS SHELL; TIN; URTICA URENS 6; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9027_b11c3141-06ac-4b5a-af22-74f8888007eb 48951-9027 HUMAN OTC DRUG Urtica Conchae Urtica Conchae PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OSTREA EDULIS SHELL; TIN; URTICA URENS 2; 12; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-9028_20d4feec-ea61-4a3b-a712-e3995d2a1fa9 48951-9028 HUMAN OTC DRUG Triticum 3 Triticum 3 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. WHEAT 3 [hp_X]/1 48951-9029_5e0549a1-4430-4b83-b05a-ea3c85ebfe49 48951-9029 HUMAN OTC DRUG Urtica dioica e pl. tota 1 Urtica dioica e pl. tota 1 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. URTICA DIOICA 2 [hp_X]/mL 48951-9032_d88e2d65-e8c1-4af7-91ec-661bd5a2b77c 48951-9032 HUMAN OTC DRUG Taraxacum e rad. autumnale 3 Taraxacum e rad. autumnale 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TARAXACUM OFFICINALE ROOT 3 [hp_X]/mL 48951-9033_0e6d5e34-c81b-427f-88be-e5d25f5fbcb2 48951-9033 HUMAN OTC DRUG Valeriana Conchae Special Order Valeriana Conchae Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OSTREA EDULIS SHELL; PHOSPHORUS; SULFUR; VALERIAN 6; 30; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9034_8a2706b4-a15b-4515-a1cf-ec2542455e98 48951-9034 HUMAN OTC DRUG Valeriana Conchae Valeriana Conchae PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OSTREA EDULIS SHELL; PHOSPHORUS; SULFUR; VALERIAN 6; 30; 30; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-9036_999e5b3d-1795-439f-9a5c-f2ae7b2bce5c 48951-9036 HUMAN OTC DRUG Valeriana e rad. 3 Valeriana e rad. 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VALERIAN 3 [hp_X]/mL 48951-9037_a77b7687-5aaf-4e4d-94af-2b7f4b5c4b58 48951-9037 HUMAN OTC DRUG Veratrum Chamomilla Veratrum Chamomilla LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; ATROPA BELLADONNA; BOS TAURUS NERVE; CUPRIC SULFATE; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; MATRICARIA RECUTITA; PRUNUS SPINOSA FLOWER BUD; VERATRUM ALBUM ROOT 6; 3; 6; 6; 6; 3; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL 48951-9038_c6e7d396-3425-4f01-9ce0-037424d6dc14 48951-9038 HUMAN OTC DRUG Veratrum Chamomilla Veratrum Chamomilla PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; ATROPA BELLADONNA; BOS TAURUS NERVE; CUPRIC SULFATE; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; MATRICARIA RECUTITA; SLOE; VERATRUM ALBUM ROOT 6; 3; 6; 6; 6; 3; 6; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-9039_62f7f7d7-f3f9-446b-abd1-cb229f4ac9bc 48951-9039 HUMAN OTC DRUG Vertebra thoracica 6 Special Order Vertebra thoracica 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BONE 6 [hp_X]/mL 48951-9040_c8ee3870-82ee-476f-905e-78905268b147 48951-9040 HUMAN OTC DRUG Vertebra lumbalis 6 Vertebra lumbalis 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BONE 6 [hp_X]/mL 48951-9041_ddbac53d-08ee-4fc4-ac5c-de96d93c027d 48951-9041 HUMAN OTC DRUG Vesica fellea Ferrum 17/20 Special Order Vesica fellea Ferrum 17/20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS GALLBLADDER; ECHINACEA ANGUSTIFOLIA; IRON; SILVER 17; 3; 20; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9042_cb5d84f9-fd9c-4bcc-af51-38da28c8d431 48951-9042 HUMAN OTC DRUG Vesica fellea Ferrum 17/20 Special Order Vesica fellea Ferrum 17/20 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS GALLBLADDER; IRON 17; 20 [hp_X]/1; [hp_X]/1 48951-9043_d91b72de-797c-4d6e-821b-c125beb51c73 48951-9043 HUMAN OTC DRUG Vesica fellea Ferrum 6/8 Special Order Vesica fellea Ferrum 6/8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS GALLBLADDER; CHELIDONIUM MAJUS ROOT; IRON; TURMERIC 6; 3; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9044_51f51206-c728-4459-b87b-ca7589e8221e 48951-9044 HUMAN OTC DRUG Vesica fellea 6 Special Order Vesica fellea 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS GALLBLADDER 6 [hp_X]/mL 48951-9045_94c445d6-fdf5-4cb7-af95-0faeab9e8c0b 48951-9045 HUMAN OTC DRUG Vespa crabro ex animale 6 Special Order Vespa crabro ex animale 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VESPA CRABRO 6 [hp_X]/mL 48951-9047_f4ae142d-5d2d-495d-9609-4d28ca36bef7 48951-9047 HUMAN OTC DRUG Viola comp. Special Order Viola comp. Special Order GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; SAMBUCUS NIGRA FLOWERING TOP; URTICA DIOICA; VIOLA ODORATA FLOWERING TOP 5; 2; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 48951-9048_5dc160ef-e539-48b9-a23f-b09b35182e16 48951-9048 HUMAN OTC DRUG Viscum 1 Viscum 1 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/g 48951-9049_0cb29863-7403-4e4f-8e67-b3774ecbbfea 48951-9049 HUMAN OTC DRUG Viscum 3 Viscum 3 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/g 48951-9050_e0bb8550-e616-4eec-9cb0-add0e5cdbca5 48951-9050 HUMAN OTC DRUG Viscum 10 Viscum 10 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/g 48951-9055_03df7eae-4dff-448c-bf44-fbabb890c66b 48951-9055 HUMAN OTC DRUG Viscum Abietis e pl. tota 4 Special Order Viscum Abietis e pl. tota 4 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 4 [hp_X]/mL 48951-9060_3a791d03-a35b-44d4-b3cc-9058656664a9 48951-9060 HUMAN OTC DRUG Viscum album 1 Special Order Viscum album 1 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL 48951-9061_154ed979-4aad-45ce-8e95-027cfde86174 48951-9061 HUMAN OTC DRUG Viscum Belladonna Viscum Belladonna LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; ATROPA BELLADONNA; GOLD; VISCUM ALBUM FRUITING TOP 6; 12; 10; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9062_4368dce4-69fe-455d-90fe-c8cae2375938 48951-9062 HUMAN OTC DRUG Viscum Belladonna Viscum Belladonna PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; ATROPA BELLADONNA; GOLD; VISCUM ALBUM FRUITING TOP 6; 12; 10; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-9072_556b716a-54ac-4eef-8246-756aba5caf69 48951-9072 HUMAN OTC DRUG Viscum Crataegus Viscum Crataegus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; GOLD; HAWTHORN LEAF WITH FLOWER; VISCUM ALBUM FRUITING TOP 17; 10; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9073_058ca645-b45c-4d57-ad3e-0671e495bbdc 48951-9073 HUMAN OTC DRUG Viscum Crataegus Viscum Crataegus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; GOLD; HAWTHORN LEAF WITH FLOWER; VISCUM ALBUM FRUITING TOP 17; 10; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-9074_06140d47-52dd-4e19-a2bd-c646c766c1d4 48951-9074 HUMAN OTC DRUG Viscum Echinacea Viscum Echinacea LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; FORMICA RUFA; VISCUM ALBUM FRUITING TOP 2; 3; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9075_740fdbf5-3cfe-40f4-958e-f39923a6e468 48951-9075 HUMAN OTC DRUG Viscum Echinacea Viscum Echinacea PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; FORMICA RUFA; VISCUM ALBUM FRUITING TOP 2; 3; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-9084_d0019c84-8158-469a-a704-212cf4c39e53 48951-9084 HUMAN OTC DRUG Viscum Mali 4 Viscum Mali 4 SPRAY NASAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 4 [hp_X]/mL 48951-9085_00f5879b-67da-4510-abd1-b9b7fb061558 48951-9085 HUMAN OTC DRUG Viscum Mali e pl. tota 5% Viscum Mali e pl. tota 5% PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/1 48951-9122_09e92815-3288-4430-bb72-78c33f2bccdd 48951-9122 HUMAN OTC DRUG Viscum comp. Viscum comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; PHOSPHORUS; VISCUM ALBUM FRUITING TOP 8; 30; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9144_7fadc775-2a81-4132-a72f-47dc0271c483 48951-9144 HUMAN OTC DRUG Viscum Stannum Viscum Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF; BRYONIA ALBA ROOT; MAMMAL LIVER; TIN; VISCUM ALBUM FRUITING TOP 8; 3; 6; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9145_e3b5a85e-7ee0-4f17-9104-df4db2f957f1 48951-9145 HUMAN OTC DRUG Viscum Stannum Viscum Stannum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF; BRYONIA ALBA ROOT; MAMMAL LIVER; TIN; VISCUM ALBUM FRUITING TOP 8; 3; 6; 10; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-9157_34eaadf0-1206-496b-b638-f64518b50c0b 48951-9157 HUMAN OTC DRUG Vitamin E Adult Size Special Order Vitamin E Adult Size Special Order SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. .ALPHA.-TOCOPHEROL 200 [iU]/g 48951-9158_7284ce38-2487-43df-9469-8c0e21e0a983 48951-9158 HUMAN OTC DRUG Vitis Stibium Vitis Stibium TABLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; CALCIUM CATION; FRAGARIA VESCA WHOLE; VITIS VINIFERA LEAF 5; 3; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-9159_945138f4-31ca-11df-9aae-0800200c9a66 48951-9159 HUMAN OTC DRUG Wild Yam Ginger Snoring DIOSCOREA VILLOSA ROOT GINGER SPRAY NASAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc DIOSCOREA VILLOSA ROOT; GINGER 2; 2 [hp_X]/1; [hp_X]/1 48951-9160_5eea51f4-cb7d-4289-9755-cfc6b6c91a54 48951-9160 HUMAN OTC DRUG Willow Fern Willow Fern PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ASPLENIUM SCOLOPENDRIUM TOP; DRYOPTERIS FILIX-MAS ROOT; PTERIDIUM AQUILINUM WHOLE; SALIX ALBA FLOWER; SALIX PURPUREA BARK; WILLOW BARK 3; 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-9166_df250aba-48bd-4cd4-bfd0-57caf21b1df8 48951-9166 HUMAN OTC DRUG Aconitum Belladonna Aconitum Belladonna LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA 5; 4 [hp_X]/mL; [hp_X]/mL 48951-9167_98158025-9dd4-4ca4-9d8e-30d46baccfe7 48951-9167 HUMAN OTC DRUG Aconitum Belladonna Aconitum Belladonna PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 48951-9170_6cd097ee-1eba-45cf-a0fc-3c0bc240bc5d 48951-9170 HUMAN OTC DRUG Aconitum Bryonia Aconitum Bryonia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT 3; 3 [hp_X]/mL; [hp_X]/mL 48951-9171_19e03283-1bda-4587-bf72-b134bb654497 48951-9171 HUMAN OTC DRUG Aconitum e tub. 30 Aconitum e tub. 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS 30 [hp_X]/mL 48951-9175_8b4b6f74-3982-4c9d-aad2-97162a81b329 48951-9175 HUMAN OTC DRUG Jewelweed 20 Jewelweed 20 GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IMPATIENS BALSAMINA FLOWER 1 [hp_X]/g 48951-9176_877f70fd-9fea-43d8-9614-8669e7f05a47 48951-9176 HUMAN OTC DRUG Vesica urinaria 8 Special Order Vesica urinaria 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA URINARY BLADDER 8 [hp_X]/mL 48951-9177_5206f5f9-6355-42ff-9ad9-d59eff9293bb 48951-9177 HUMAN OTC DRUG Urtica Betula Special Order Urtica Betula Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; BOS TAURUS BONE MARROW; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; SILVER SULFIDE; URTICA DIOICA 4; 8; 6; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9178_3d79ddaa-931a-47bf-a65b-7739a89b9cb4 48951-9178 HUMAN OTC DRUG Tourmaline Formica comp. Special Order Tourmaline Formica comp. Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY TRISULFIDE; BEEF HEART; FORMICA RUFA; SCHORL TOURMALINE 6; 6; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9179_2796d462-cd7a-4461-8bed-fe83837c4654 48951-9179 HUMAN OTC DRUG Thuja e summ. 6 Special Order Thuja e summ. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THUJA OCCIDENTALIS WHOLE 6 [hp_X]/mL 48951-9180_f5ad67a7-3d89-4839-bb80-af8afe9e1e99 48951-9180 HUMAN OTC DRUG Valvula aortae 6 Special Order Valvula aortae 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART 6 [hp_X]/mL 48951-9181_1aef1431-6a34-4950-806a-5e9114db5c30 48951-9181 HUMAN OTC DRUG Vespa crabro 15 Special Order Vespa crabro 15 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VESPA CRABRO 15 [hp_X]/mL 48951-9182_275296f0-f5e6-4095-9c39-ebab173d1e96 48951-9182 HUMAN OTC DRUG Thrombocytes 30 Special Order Thrombocytes 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUUS CABALLUS WHOLE 30 [hp_X]/mL 48951-9183_9d2b559b-fc00-484a-9b1a-07f29f0b0723 48951-9183 HUMAN OTC DRUG Tourmaline 30 Special Order Tourmaline 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SCHORL TOURMALINE 30 [hp_X]/mL 48951-9184_d59200a1-a1cc-44a3-8b6b-0a19a3f6cd14 48951-9184 HUMAN OTC DRUG Thyreoidea Ferrum Special Order Thyreoidea Ferrum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON; THYROID, UNSPECIFIED 12; 6 [hp_X]/mL; [hp_X]/mL 48951-9185_de2bff11-4a80-4cf3-9f9c-2e64b516a828 48951-9185 HUMAN OTC DRUG Taraxacum e rad. vernale 3 Special Order Taraxacum e rad. vernale 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TARAXACUM OFFICINALE ROOT 3 [hp_X]/mL 48951-9186_65a8c1b8-b2e3-49b0-8a2f-56e0eda78fbd 48951-9186 HUMAN OTC DRUG Viscum Quercus 3 Special Order Viscum Quercus 3 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 3 [hp_X]/1 48951-9187_c172009e-e8f9-494f-a694-c1ee6630871e 48951-9187 HUMAN OTC DRUG Testes Arnica Special Order Testes Arnica Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BOS TAURUS TESTICLE 6; 6 [hp_X]/mL; [hp_X]/mL 48951-9188_cc5c2fd2-0cac-4631-8519-235bff1db996 48951-9188 HUMAN OTC DRUG Tuba auditiva 6 Special Order Tuba auditiva 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA EAR 6 [hp_X]/1 48951-9189_abcb9077-8e7f-47fb-b34c-f39de9cc54a8 48951-9189 HUMAN OTC DRUG Urtica dioica ex herba Essence Special Order Urtica dioica ex herba Essence Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. URTICA DIOICA LEAF 1 [hp_X]/mL 48951-9190_cc310c8a-b77a-4c67-9adc-1d10399df1d5 48951-9190 HUMAN OTC DRUG Thalamus 8 Special Order Thalamus 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA THALAMUS 8 [hp_X]/mL 48951-9192_f3a32667-c86a-4827-9639-31f6ad16ca98 48951-9192 HUMAN OTC DRUG Viscum 30 Special Order Viscum 30 Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/g 48951-9193_9292c3b9-9a9e-48cb-a6da-5b10213e6527 48951-9193 HUMAN OTC DRUG Vesica fellea Ferrum 6/8 Special Order Vesica fellea Ferrum 6/8 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS GALLBLADDER; IRON 6; 8 [hp_X]/1; [hp_X]/1 48951-9194_0a186550-e1b9-416a-ac18-0727150207c4 48951-9194 HUMAN OTC DRUG Viola Chamomilla Special Order Viola Chamomilla Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; FERROSOFERRIC PHOSPHATE; MATRICARIA RECUTITA; MERCURIC IODIDE; VIOLA ODORATA FLOWERING TOP 7; 12; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 48951-9195_06b1632a-8c15-4414-992f-8f2be907c9a2 48951-9195 HUMAN OTC DRUG Taraxacum e pl. tota 2 Special Order Taraxacum e pl. tota 2 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TARAXACUM PALUSTRE ROOT 2 [hp_X]/mL 48951-9197_0185ffe9-1e8f-4693-92c5-abf04a78ba22 48951-9197 HUMAN OTC DRUG Thuja e summ. 3 Special Order Thuja e summ. 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THUJA OCCIDENTALIS WHOLE 3 [hp_X]/mL 48951-9198_dbc93a8d-fb42-47ca-b2e4-af9d26d6be42 48951-9198 HUMAN OTC DRUG Viscum Quercus 6 Special Order Viscum Quercus 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 6 [hp_X]/mL 48951-9998_fa4e73f6-1039-11df-8a39-0800200c9a66 48951-9998 HUMAN OTC DRUG Saline SODIUM CHLORIDE SOLUTION/ DROPS ORAL 20100201 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc SODIUM CHLORIDE 1 [hp_X]/1 48951-9999_b5cb3250-1038-11df-8a39-0800200c9a66 48951-9999 HUMAN OTC DRUG Sucrose SUCROSE PELLET ORAL 20100201 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc SUCROSE 1 [hp_X]/1 48964-112_bb27c349-d154-4974-8dce-4c79ebea9659 48964-112 HUMAN OTC DRUG nexafed pseudoephedrine HCL TABLET ORAL 20121210 OTC MONOGRAPH FINAL part341 Acura Pharmaceuticals, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 49035-000_db1d90bb-eddd-4f64-bb96-627cd422ada3 49035-000 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20130318 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 49035-001_1e5720c6-5bd6-4e6b-8d97-719fdd1df806 49035-001 HUMAN OTC DRUG Diaper Rash Zinc oxide CREAM TOPICAL 19940131 OTC MONOGRAPH NOT FINAL part347 Wal-Mart Stores Inc ZINC OXIDE 130 mg/g 49035-002_04c7440e-5b25-4b63-9604-321298d51021 49035-002 HUMAN OTC DRUG equate enema Saline ENEMA RECTAL 20100223 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 49035-003_6c87d372-4ba1-4c2c-ad7a-34a545c0a900 49035-003 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20050620 OTC MONOGRAPH FINAL part333D Wal-Mart Stores Inc SALICYLIC ACID 19.8 mg/g 49035-004_daf96fba-2b93-4def-9a37-bec486e4ac47 49035-004 HUMAN OTC DRUG Anticavity Fluoride Rinse Anticavity Fluoride Rinse MOUTHWASH ORAL 20040406 OTC MONOGRAPH FINAL part355 Wal Mart SODIUM FLUORIDE .02 mL/100L 49035-005_211a112e-1891-4942-9f01-dce491c8c53e 49035-005 HUMAN OTC DRUG Stool Softener Gentle Relief DOCUSATE SODIUM CAPSULE ORAL 20110331 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM 100 mg/1 49035-006_7b70785f-6357-46e1-860c-9584060ddaf3 49035-006 HUMAN OTC DRUG Hair Regrowth Treatment for Women Minoxidil SOLUTION TOPICAL 20040204 ANDA ANDA074588 Wal-Mart Stores, Inc. MINOXIDIL 20 mg/mL 49035-007_bce2393f-be45-42ed-9399-896359fa9a30 49035-007 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090522 OTC MONOGRAPH FINAL part333 Wal-Mart Stores Inc ISOPROPYL ALCOHOL 70 mL/100mL 49035-008_72695921-72c6-440c-b823-f8ac9173cf57 49035-008 HUMAN OTC DRUG Wintergreen Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090506 OTC MONOGRAPH FINAL part333 Wal-Mart Stores Inc ISOPROPYL ALCOHOL 70 mL/100mL 49035-009_22ddb82e-72f2-4292-b222-3b708092d2d5 49035-009 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20050208 OTC MONOGRAPH FINAL part358H Wal-Mart Stores, Inc COAL TAR 25 mg/mL 49035-010_3866a4ec-c51f-d62f-7308-da420c0dd0d2 49035-010 HUMAN OTC DRUG Allergy Relief Cetirizine Hydrochloride Tablets TABLET, FILM COATED ORAL 20110208 ANDA ANDA078343 Wal-Mart Stores Inc CETIRIZINE HYDROCHLORIDE 5 mg/1 49035-013_c898f1f8-b066-4ce0-8e18-f76a83a81d85 49035-013 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130930 OTC MONOGRAPH FINAL part341 EQUATE (Walmart Stores, Inc.) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 49035-014_9609888b-79bd-4a32-8cbe-79dc0d1592f6 49035-014 HUMAN OTC DRUG EQUATE ANTIBACTERIAL FOAMING HAND SPRING SHOWERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140817 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORE INC BENZALKONIUM CHLORIDE 1.3 mg/mL 49035-014_ce2410d1-0de3-4435-9bdd-f0a7746b6172 49035-014 HUMAN OTC DRUG EQUATE ANTIBACTERIAL FOAMING HAND SPRING SHOWERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140817 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC BENZALKONIUM CHLORIDE 1.3 mg/mL 49035-015_b270501f-b883-4b2e-8754-190927b43848 49035-015 HUMAN OTC DRUG Diphenhydramine HCl and Zinc Acetate Anti-Itch Continuous Spray AEROSOL, SPRAY TOPICAL 20130303 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1.5; .075 g/88mL; g/88mL 49035-016_9196d85a-c3dd-46b8-abb4-7315ed2c07c4 49035-016 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Wal-Mart Stores, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 49035-017_5b7805b0-be13-4878-81ac-9fc3b04a8f2b 49035-017 HUMAN OTC DRUG Maximum Strength Wart Remover with Salicylic Acid Wart Remover with Salicylic Acid LIQUID TOPICAL 20111231 OTC MONOGRAPH FINAL part358B Wal-Mart Stores, Inc. SALICYLIC ACID 17 mg/100mg 49035-018_88013105-92c6-4210-ac00-0f2e16ecb93f 49035-018 HUMAN OTC DRUG Salicylic Acid Liquid Corn and Callus Remover LIQUID TOPICAL 20140304 OTC MONOGRAPH FINAL part358F Wal-Mart Stores, Inc. SALICYLIC ACID .17 g/g 49035-019_3621f579-b061-4a4e-bafe-6c26f894727c 49035-019 HUMAN OTC DRUG Extra Thick Callus Removers Extra Thick Callus Removers with Salicylic Acid PATCH TOPICAL 20130801 OTC MONOGRAPH FINAL part358F Wal-Mart Stores, Inc. SALICYLIC ACID 40 mg/100mg 49035-020_377a73c8-06c1-4405-9521-21db4e483dde 49035-020 HUMAN OTC DRUG Equate Repairing Benzoyl Peroxide LOTION TOPICAL 20111010 OTC MONOGRAPH NOT FINAL part333D Wal-Mart Stores Inc BENZOYL PEROXIDE 25 mg/mL 49035-021_4d9de360-92c8-4d41-bb59-7d62656396dc 49035-021 HUMAN OTC DRUG BENZOYL PEROXIDE BENZOYL PEROXIDE KIT TOPICAL 20100226 OTC MONOGRAPH NOT FINAL part333D Wal-Mart Stores Inc 49035-022_e6837d64-e885-4999-b481-dcebb1aed420 49035-022 HUMAN OTC DRUG Equate Maximum Strength Spot Treatment BENZOYL PEROXIDE GEL TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333D Wal-Mart Stores Inc BENZOYL PEROXIDE 135 mg/g 49035-023_359763f3-d55a-4001-8c9d-a2193118bd4e 49035-023 HUMAN OTC DRUG Equate Cleansing Pads SALICYLIC ACID SWAB TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333D Wal-Mart Stores Inc SALICYLIC ACID 21 mg/1 49035-024_20079dc1-43b6-4daf-b913-6fe07961a55f 49035-024 HUMAN OTC DRUG Equate Acne Treatment Body Pads SALICYLIC ACID SWAB TOPICAL 20110713 OTC MONOGRAPH NOT FINAL part333D Wal-Mart Stores Inc SALICYLIC ACID 20 mg/1 49035-025_9bcec8f7-8532-42b8-92d9-19c5dde5a90b 49035-025 HUMAN OTC DRUG Equate Purifying Cleanser Benzoyl Peroxide GEL TOPICAL 20111010 OTC MONOGRAPH NOT FINAL part333D Wal-Mart Stores Inc BENZOYL PEROXIDE 25 mg/mL 49035-026_90074711-62ce-445f-8682-19639b60b3ff 49035-026 HUMAN OTC DRUG ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN and DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20140601 OTC MONOGRAPH NOT FINAL part343 WALMART STORES INC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 49035-028_7be9cc4a-bfe9-4851-996b-658b558bc2a4 49035-028 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20141031 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) MAGNESIUM CITRATE 1.745 g/29.6mL 49035-029_d2d7165e-c895-40ec-a4c2-53b1a8653a25 49035-029 HUMAN OTC DRUG Equate nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050309 ANDA ANDA076775 Wal-Mart Stores Inc NICOTINE 2 mg/1 49035-030_e7cd5fd4-ff5f-477c-a080-486c9b8a33a6 49035-030 HUMAN OTC DRUG Calamine Plus FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE AEROSOL, SPRAY TOPICAL 20130303 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores, Inc. FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE .345; 2.72; 24.16 mg/mL; mg/mL; mg/mL 49035-032_54b2f88b-f828-4e5d-a85c-09f9803c29b2 49035-032 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20141031 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) MAGNESIUM CITRATE 1.745 g/29.6mL 49035-034_be89dec9-4df3-4ec4-b125-5cdbabdd4f01 49035-034 HUMAN OTC DRUG Shiny and Sleek pyrithione zinc SHAMPOO TOPICAL 19990206 OTC MONOGRAPH FINAL part358H Wal-Mart PYRITHIONE ZINC 10 mg/mL 49035-035_7c27a4c9-e8f8-47fe-beaf-6d5e239ff801 49035-035 HUMAN OTC DRUG Mineral oil Mineral oil OIL ORAL 20141031 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) MINERAL OIL 100 mg/100mL 49035-037_71d474a5-767a-4c34-a4fe-1815562be0ad 49035-037 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141130 OTC MONOGRAPH FINAL part341 EQUATE (Walmart Stores, Inc.) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL 49035-038_a1ae658b-cbf5-4548-aa3f-580dad92b4e6 49035-038 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 19900415 OTC MONOGRAPH FINAL part347 Wal-Mart Stores, Inc PETROLATUM 1 g/g 49035-039_2d1cccf8-82df-4f8e-bbcc-b48a5931e5f0 49035-039 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20140530 OTC MONOGRAPH FINAL part347 EQUATE (Walmart Stores, Inc.) WITCH HAZEL 842 mg/mL 49035-041_4492c96a-c686-404e-ae15-b482acc3bb02 49035-041 HUMAN OTC DRUG Nighttime Cold and Flu acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090807 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 49035-043_e0d3d935-92bd-4d52-ada2-f9c05b0697a2 49035-043 HUMAN OTC DRUG equate Fiber Therapy Original Texture Unflavored PSYLLIUM HUSK GRANULE, FOR SOLUTION ORAL 20120905 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc PSYLLIUM HUSK 3.4 g/7g 49035-047_f63fa283-52b5-422c-8c15-b15f7062d284 49035-047 HUMAN OTC DRUG Acetaminophen PM Extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20141130 OTC MONOGRAPH FINAL part341 EQUATE (Walmart Stores, Inc.) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 49035-049_5d94b033-a410-427e-a1fe-968fc5610e3a 49035-049 HUMAN OTC DRUG Equate Pain Relieving Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20050628 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g 49035-050_3f272d46-6367-4ed9-a058-1325ae383922 49035-050 HUMAN OTC DRUG First Aid Antiseptic POVIDONE-IODINE SOLUTION TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores, Inc. POVIDONE-IODINE 10 kg/100L 49035-054_7f662a2d-c193-4376-b187-28c92718b014 49035-054 HUMAN OTC DRUG equate suphedrine Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000719 ANDA ANDA075153 Wal-Mart Stores Inc PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 49035-056_8d4afe48-c349-4c79-a0cb-65a4a76d9216 49035-056 HUMAN OTC DRUG Equate NiteTime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140128 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 49035-066_9dd2aa5c-44c5-4a17-9cc2-449787155a52 49035-066 HUMAN OTC DRUG equate Sugar Free Fiber Therapy Smooth Texture Orange Flavor PSYLLIUM HUSK GRANULE, FOR SOLUTION ORAL 20120905 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc PSYLLIUM HUSK 3.5 g/5.8g 49035-067_32b1a2ea-b275-4303-a6c9-a3b7320e8bff 49035-067 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate OINTMENT TOPICAL 20100831 OTC MONOGRAPH FINAL part333B Wal-Mart Stores, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 49035-068_4b09ed20-909f-415c-8d6f-313e99ae52a0 49035-068 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140212 ANDA ANDA079096 EQUATE (Walmart Stores, Inc.) NAPROXEN SODIUM 220 mg/1 49035-069_25a7fb38-8a9f-4b12-8b3e-faf07f535afb 49035-069 HUMAN OTC DRUG equate Fiber Therapy Smooth Texture Orange Flavor PSYLLIUM HUSK GRANULE, FOR SOLUTION ORAL 20121001 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc PSYLLIUM HUSK 3.4 g/12g 49035-071_ce2013c9-bcc9-4445-ba52-212b3988a150 49035-071 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20120110 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores, Inc MENTHOL 1.5 mg/g 49035-072_e7a3d272-3f70-4f2b-93f5-8f64bd0d9e85 49035-072 HUMAN OTC DRUG Antiseptic Mouthrinse Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 19891111 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 49035-075_073cff34-3cdc-4f0b-945b-c3119fa28b58 49035-075 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20140930 NDA NDA021920 EQUATE (Walmart Stores, Inc.) NAPROXEN SODIUM 220 mg/1 49035-076_422d93bc-46d5-4924-ab34-6436f17605a3 49035-076 HUMAN OTC DRUG Isopropyl alcohol 70 percent Wintergreen Isopropyl alcohol LIQUID TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part333A EQUATE (Walmart Stores, Inc.) ISOPROPYL ALCOHOL 70 mL/100mL 49035-080_b2ea9d75-5626-47fa-93f9-222942bb65ad 49035-080 HUMAN OTC DRUG equate Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Wal-Mart Stores Inc TERBINAFINE HYDROCHLORIDE 1 g/100g 49035-082_c91e94f4-4c51-4fe7-ad2e-0b9dc58b51e4 49035-082 HUMAN OTC DRUG equate childrens cold and cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20060812 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 49035-083_342193c8-5346-4a8b-82cb-d9bd2e79a7c0 49035-083 HUMAN OTC DRUG equate ibuprofen cold and sinus Ibuprofen, Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011107 ANDA ANDA074567 Wal-Mart Stores Inc IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 49035-088_67cd0670-e085-4ecd-836e-97efc8e99087 49035-088 HUMAN OTC DRUG Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Wal-Mart Stores Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 49035-090_3bbc126e-dce5-4d1b-8276-975ebf23958a 49035-090 HUMAN OTC DRUG equate daytime nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110928 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc 49035-090_91c6df3e-0279-4736-8b3b-402a1bc8a4e0 49035-090 HUMAN OTC DRUG equate daytime nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120907 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc 49035-091_76baf4c6-a130-4419-af13-e5030654fdaf 49035-091 HUMAN OTC DRUG All Day Moisturizing Octinoxate, zinc oxide LOTION TOPICAL 20060407 OTC MONOGRAPH FINAL part352 Wal-Mart Stores, Inc OCTINOXATE; ZINC OXIDE 60; 30 mg/mL; mg/mL 49035-092_b12e1df6-1da9-4d77-9862-667dbc1030f6 49035-092 HUMAN OTC DRUG equate Childrens Allergy Relief Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Wal-Mart Stores Inc LORATADINE 5 mg/5mL 49035-094_7fd8d757-2465-47fb-97aa-39e7cdfbe8cf 49035-094 HUMAN OTC DRUG Equate Nasal Decongestant PE Maximum Strength Phenylephrine Hydrochloride TABLET ORAL 20050207 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 49035-096_620a6710-56d3-473e-b788-d89ff9e2615d 49035-096 HUMAN OTC DRUG equate flu and severe cold and cough Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20120228 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 49035-098_e24b94b8-96d9-4297-be24-12a7f6bb17b6 49035-098 HUMAN OTC DRUG Equate Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20130809 NDA NDA021920 Wal-Mart Stores Inc NAPROXEN SODIUM 220 mg/1 49035-099_e734bb75-682a-408c-9a9d-dceb008a01b8 49035-099 HUMAN OTC DRUG Vaporizing Camphor INHALANT RESPIRATORY (INHALATION) 20140307 OTC MONOGRAPH FINAL part341 Wal-Mart Stores, Inc CAMPHOR (SYNTHETIC) 62 mg/mL 49035-101_e05a4f41-3fe3-4f0e-a402-2c2f0fef804c 49035-101 HUMAN OTC DRUG Hand Sanitizer Bodycology Ethyl Alcohol GEL TOPICAL 20110407 OTC MONOGRAPH FINAL part333E Wal-Mart Stores, Inc. ALCOHOL 70 mL/100mL 49035-102_9dcf7e8f-6341-4046-aa20-82a256f4e861 49035-102 HUMAN OTC DRUG Hand Sanitizer Bodycology Ethyl Alcohol GEL TOPICAL 20110407 OTC MONOGRAPH FINAL part333E Wal-Mart Stores, Inc ALCOHOL 70 mL/100mL 49035-103_48389dcb-b4eb-4e1e-9fc8-e5837ea4d587 49035-103 HUMAN OTC DRUG Exotic Cherry Hand Sanitizer bodycology Alcohol LIQUID TOPICAL 20130520 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc ALCOHOL 75 g/100mL 49035-104_0c9b9dde-0e27-4eaa-a2c0-4b6818a928ee 49035-104 HUMAN OTC DRUG Pretty in Paris Hand Sanitizer bodycology Alcohol LIQUID TOPICAL 20130521 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc ALCOHOL 75 g/100mL 49035-105_7fb82ca2-15d3-4c96-bea1-24b7a7e813f5 49035-105 HUMAN OTC DRUG Equate Childrens acetaminophen Acetaminophen SUSPENSION ORAL 19960402 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/5mL 49035-106_6a579bb6-4ee6-4e9a-b019-1f64a4371fe1 49035-106 HUMAN OTC DRUG Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Wal-Mart Stores Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 49035-107_628e51b6-51bb-4b4e-a516-9994ca05790b 49035-107 HUMAN OTC DRUG blackberry vanilla hand sanitizer bodycology Alcohol LIQUID TOPICAL 20130521 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc ALCOHOL 75 g/100mL 49035-108_f5f4eefa-d8f5-4b68-81f6-915545331974 49035-108 HUMAN OTC DRUG sweet love hand sanitizer bodycology Alcohol LIQUID TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc ALCOHOL 75 g/100mL 49035-109_c4bee47e-a5be-4159-b419-fe5725843021 49035-109 HUMAN OTC DRUG winter vanilla hand sanitizer bodycology Alcohol LIQUID TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc ALCOHOL 75 1/100mL 49035-110_0fe94699-e766-464c-80fb-343fa12f8d15 49035-110 HUMAN OTC DRUG EQUATE SPRING SHOWERS ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC. TRICLOSAN 4.6 mg/mL 49035-110_51d1d0d2-7f33-4e4d-9fa7-beec3ea7cdd9 49035-110 HUMAN OTC DRUG EQUATE SPRING SHOWERS ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC. TRICLOSAN 4.6 mg/mL 49035-111_26d6f847-ae05-4ea2-869c-e8108b5846f7 49035-111 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120301 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM 100 mg/1 49035-112_712bd580-9b69-4a8c-8137-c006082e9215 49035-112 HUMAN OTC DRUG Suphedrine Pseudoephedrine HCl TABLET ORAL 19810825 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 49035-113_b5ec1f20-2826-4dac-8e19-fbcb970c2526 49035-113 HUMAN OTC DRUG frosted sugar plum hand sanitizer bodycology Alcohol LIQUID TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc ALCOHOL 75 g/100mL 49035-114_e5713d3d-eff9-4c1e-9745-9c31c310698b 49035-114 HUMAN OTC DRUG EQUATE SPRING SHOWERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131030 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC BENZALKONIUM CHLORIDE 1.3 mg/mL 49035-114_fc9b67d2-2da2-4e16-8aaf-84521fd66ef5 49035-114 HUMAN OTC DRUG EQUATE SPRING SHOWERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131018 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC BENZALKONIUM CHLORIDE 1.3 mg/mL 49035-118_1d11f3b5-9d0e-d553-c3eb-9e0aa16bd736 49035-118 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20120705 ANDA ANDA077367 Wal-Mart Stores Inc FAMOTIDINE 10 mg/1 49035-123_a7875f9c-fdf7-4def-a860-61465184716f 49035-123 HUMAN OTC DRUG Clotrimazole Jock Itch Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Wal-Mart Stores, Inc. CLOTRIMAZOLE 10 mg/g 49035-124_6c0d9058-c971-42d8-baf9-cbcfb855c44a 49035-124 HUMAN OTC DRUG equate nicotine Nicotine Polacrilex LOZENGE ORAL 20090910 ANDA ANDA090711 Wal-Mart Stores Inc NICOTINE 2 mg/1 49035-126_3d54ab30-ecb9-4816-a462-73513818c997 49035-126 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20120517 ANDA ANDA074916 Wal-Mart Stores, Inc. IBUPROFEN 100 mg/5mL 49035-127_3d54ab30-ecb9-4816-a462-73513818c997 49035-127 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20120517 ANDA ANDA074916 Wal-Mart Stores, Inc. IBUPROFEN 100 mg/5mL 49035-128_0becc489-941b-4e34-bbd0-338dec9ab0e5 49035-128 HUMAN OTC DRUG Famotidine original strength Famotidine TABLET ORAL 20121218 ANDA ANDA077146 EQUATE (Walmart Stores, Inc.) FAMOTIDINE 10 mg/1 49035-130_d7e4c6b8-0ac5-488e-8cc8-3af1aa24c7dc 49035-130 HUMAN OTC DRUG equate childrens acetaminophen Acetaminophen SUSPENSION ORAL 19930617 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/5mL 49035-131_b4ee2016-9462-4694-86ab-b81ec9bf5f4d 49035-131 HUMAN OTC DRUG Equate Suphedrine PE Phenylephrine Hydrochloride TABLET ORAL 20140321 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 49035-133_f1f051d8-b8d8-4afd-84d8-82a59d9fa4fb 49035-133 HUMAN OTC DRUG Equate Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20140702 ANDA ANDA079205 Walmart stores Inc IBUPROFEN 200 mg/1 49035-140_ad995658-b0be-4ce3-baa2-dbdf787ece17 49035-140 HUMAN OTC DRUG Equate Naproxen Sodium Naproxen sodium TABLET, FILM COATED ORAL 20130809 ANDA ANDA074661 Wal-Mart Stores Inc NAPROXEN SODIUM 200 mg/1 49035-141_34834524-b5d4-4e21-9163-29c499043b2d 49035-141 HUMAN OTC DRUG equate Acid Controller Original Strength Famotidine TABLET ORAL 20091030 ANDA ANDA075400 Wal-Mart Stores Inc FAMOTIDINE 10 mg/1 49035-142_07c1a066-9750-424a-b295-01e4f6bfffc8 49035-142 HUMAN OTC DRUG Equate vagicaine maximum strength Benzocaine, Resorcinol CREAM TOPICAL 20050628 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc BENZOCAINE; RESORCINOL 20; 3 g/100g; g/100g 49035-148_74e8d558-a4ea-47ae-975e-ae662a2db1d0 49035-148 HUMAN OTC DRUG Extra Strength Acetaminophen Acetaminophen TABLET ORAL 19930121 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 500 mg/1 49035-150_4eff620e-ec4e-4655-9f7b-40bc655f9605 49035-150 HUMAN OTC DRUG Stool Softener Extra strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140224 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM 250 mg/1 49035-151_a2c85ab2-bc07-43a7-81b0-495c833b1720 49035-151 HUMAN OTC DRUG Equate Corn and Callus Remover Salicylic Acid LIQUID TOPICAL 20101001 OTC MONOGRAPH FINAL part358B Wal-Mart Stores Inc. SALICYLIC ACID 170 mL/mL 49035-152_15f6de88-46f8-4c0d-92d7-84da2d375c9d 49035-152 HUMAN OTC DRUG Equate One Step Corn Remover Pad Salicylic Acid LIQUID TOPICAL 20101001 OTC MONOGRAPH FINAL part358B Wal-Mart Stores Inc. SALICYLIC ACID 40 mg/1 49035-153_a21bc9eb-f671-4eaa-bc43-f60a8b047d14 49035-153 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950715 OTC MONOGRAPH FINAL part358H Wal-Mart Stores, Inc. PYRITHIONE ZINC 10 mg/mL 49035-154_de85bbf2-f6ea-45bc-ba1c-8806e285f3cb 49035-154 HUMAN OTC DRUG Equate Athletes Foot tolnaftate SPRAY TOPICAL 20040907 OTC MONOGRAPH FINAL part333C Wal-Mart Stores Inc TOLNAFTATE 1 g/100g 49035-157_f9b99b6d-41f7-4438-979a-89d1edb2018c 49035-157 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20140203 OTC MONOGRAPH FINAL part343 Wal-Mart Stores Inc ASPIRIN 325 mg/1 49035-158_6b5cc061-cca4-4a62-a9a1-e653ae690366 49035-158 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20130930 OTC MONOGRAPH NOT FINAL part343 EQUATE (Walmart Stores, Inc.) ACETAMINOPHEN 500 mg/1 49035-159_1dad136a-558c-430a-94ac-f6e1950b05c4 49035-159 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 49035-160_1f6b907a-6bc3-4ef8-9973-d36339501686 49035-160 HUMAN OTC DRUG equate hemorrhodial suppositories cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20120904 OTC MONOGRAPH FINAL part346 Wal-Mart Stores Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g 49035-161_a6286824-2514-444f-ab2a-3378522191b5 49035-161 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20130315 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 49035-163_eb374aa0-5997-4602-b9f7-3761d1a5c3ba 49035-163 HUMAN OTC DRUG Anticavity SODIUM FLUORIDE MOUTHWASH ORAL 20060513 OTC MONOGRAPH FINAL part355 Wal-Mart SODIUM FLUORIDE 999.5 mL/100L 49035-166_1fc7e14d-723a-4ff7-bd31-b9a30b2bb2cf 49035-166 HUMAN OTC DRUG equate ibuprofen childrens Ibuprofen SUSPENSION ORAL 20020416 ANDA ANDA074937 Wal-Mart Stores Inc IBUPROFEN 100 mg/5mL 49035-168_86810df2-eea7-4074-9f7c-3efa818e240d 49035-168 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111024 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC TRICLOSAN .6 mL/100mL 49035-170_38b22953-534e-4b38-8423-f59d56cc7569 49035-170 HUMAN OTC DRUG Equate nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050322 ANDA ANDA076789 Wal-Mart Stores Inc NICOTINE 4 mg/1 49035-173_27283cd3-43bb-40e6-b6d4-fdd7d3749fb6 49035-173 HUMAN OTC DRUG equate lice treatment Piperonyl Butoxide, Pyrethrum Extract KIT 20070807 OTC MONOGRAPH FINAL part358G Wal-Mart Stores Inc 49035-173_fe11d8a2-3a94-4d95-84eb-b47f7b0aff55 49035-173 HUMAN OTC DRUG equate lice treatment Piperonyl Butoxide, Pyrethrum Extract KIT 20070807 OTC MONOGRAPH FINAL part358G Wal-Mart Stores Inc 49035-175_40ece6d8-3455-4de5-8e7f-bf48b338af2d 49035-175 HUMAN OTC DRUG Extra Strength Acetaminophen Acetaminophen TABLET ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 500 mg/1 49035-176_c792e37f-3d03-4fa3-ad53-75bd5d4cf166 49035-176 HUMAN OTC DRUG equate allergy relief d Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080409 ANDA ANDA077170 Wal-Mart Stores Inc CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 49035-177_f3f112dd-d22f-43fb-88f2-fabfae234e9f 49035-177 HUMAN OTC DRUG EQUATE ANTIBACTERIAL FOAMING Triclosan SOAP TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC TRICLOSAN .46 mL/100mL 49035-179_3ceeb353-ffab-4700-96b8-c9e325d90495 49035-179 HUMAN OTC DRUG Equate Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20050415 OTC MONOGRAPH FINAL part331 Wal-Mart Stores Inc CALCIUM CARBONATE 750 mg/1 49035-180_0daebe30-8961-46bf-8a67-eaa17d3fad0f 49035-180 HUMAN OTC DRUG Healing Healing Ointment OINTMENT TOPICAL 20071202 OTC MONOGRAPH FINAL part347 Wal Mart PETROLATUM 41 kg/100kg 49035-183_cd91b99e-f6cc-4653-8740-9ede653d591a 49035-183 HUMAN OTC DRUG Childrens allergy relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Wal-Mart Stores Inc LORATADINE 5 mg/5mL 49035-187_45fe337e-548a-4043-a11d-207d848dd86b 49035-187 HUMAN OTC DRUG Equate Anti-Wrinkle Avobenzone and Octocrylene CREAM TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 Walmart Stores Inc. AVOBENZONE; OCTOCRYLENE 3; 10 g/100g; g/100g 49035-188_81ecb091-38da-4b3e-a0a1-b4986b97ee09 49035-188 HUMAN OTC DRUG Equate Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140102 OTC MONOGRAPH FINAL part346 Wal-Mart Stores Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 49035-190_67abc74a-5d60-473a-b25a-9495ab49ee1e 49035-190 HUMAN OTC DRUG Equate Nicotine Nicotine Polacrilex LOZENGE ORAL 20090910 ANDA ANDA090711 Wal-Mart Stores Inc NICOTINE 4 mg/1 49035-194_cb761025-bc18-4b25-bf95-258f766282d1 49035-194 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20101019 NDA AUTHORIZED GENERIC NDA020165 Wal-Mart Stores Inc NICOTINE 21 mg/24h 49035-195_cb761025-bc18-4b25-bf95-258f766282d1 49035-195 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20101019 NDA AUTHORIZED GENERIC NDA020165 Wal-Mart Stores Inc NICOTINE 14 mg/24h 49035-196_cb761025-bc18-4b25-bf95-258f766282d1 49035-196 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20101019 NDA AUTHORIZED GENERIC NDA020165 Wal-Mart Stores Inc NICOTINE 7 mg/24h 49035-198_48b6e85f-0a26-4442-9f19-24f9970f3dff 49035-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20121211 ANDA ANDA078682 EQUATE (Walmart Stores, Inc.) IBUPROFEN 200 mg/1 49035-199_1800b776-0b58-416c-ae56-e17a6368cc91 49035-199 HUMAN OTC DRUG equate miconazole 1 Miconazole nitrate KIT 20100609 ANDA ANDA079114 Wal-Mart Stores Inc 49035-202_b9e32430-b834-499f-a1e7-260a342de8bc 49035-202 HUMAN OTC DRUG equate hair regrowth treatment for women minoxidil SOLUTION TOPICAL 20110127 ANDA ANDA075357 Wal-Mart Stores Inc MINOXIDIL 2 g/100mL 49035-205_2f13b3d2-34c6-477b-b99f-e577eb175ed3 49035-205 HUMAN OTC DRUG equate athletes foot powder Tolnaftate SPRAY TOPICAL 20040929 OTC MONOGRAPH FINAL part333C Wal-Mart Stores Inc TOLNAFTATE 1 g/100g 49035-206_52bd39c4-750c-49ba-9a76-5285c43a0eac 49035-206 HUMAN OTC DRUG equate nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050308 ANDA ANDA078325 Wal-Mart Stores Inc NICOTINE 2 mg/1 49035-210_7c73e1a0-6b72-4bd6-8c58-f9f6f6dfeef9 49035-210 HUMAN OTC DRUG Advanced Citrus Eucalyptol MOUTHWASH ORAL 20100722 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 49035-211_f79322b1-4f8d-4c27-aaff-1ec6e3daab4f 49035-211 HUMAN OTC DRUG Hand Sanitizer Pink Strawberry Lollipop Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 63 mL/100mL 49035-212_bd540f68-6ea4-403e-a2be-6deccf444d3b 49035-212 HUMAN OTC DRUG Hand Sanitizer Winter Jelly Bean Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL 49035-213_06a20df8-d148-4862-8175-972aa5b178b2 49035-213 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20010806 OTC MONOGRAPH FINAL part355 Wal-Mart SODIUM FLUORIDE .05 kg/100L 49035-214_934c51da-92e2-4945-a33f-43c6fcacc937 49035-214 HUMAN OTC DRUG Hand Sanitizer Passionfruit Pomegranate Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL 49035-215_1ec8ee8a-610a-4c54-be42-8de72fbd25bb 49035-215 HUMAN OTC DRUG equate daytime cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20061030 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 49035-216_0d8121c6-f53f-4a5a-b27b-eeb0340e3f69 49035-216 HUMAN OTC DRUG Hand Sanitizer Sweet Sugar Cookie Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL 49035-217_11103326-12da-4a41-8b3c-9f18fa894946 49035-217 HUMAN OTC DRUG Hand Sanitizer Orange Tangerine Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL 49035-218_16d68fd9-af59-43fc-9b26-1bcd7b3b0e5c 49035-218 HUMAN OTC DRUG Hand Sanitizer Juicy Blueberry Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL 49035-219_f64abd39-98e9-4553-b6ad-f6533442085c 49035-219 HUMAN OTC DRUG Hand Sanitizer Spicy Peppermint Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL 49035-220_4ebf2fa8-b7c3-4d50-ad0b-f9b19ca495c2 49035-220 HUMAN OTC DRUG Hand Sanitizer Sugared Berry Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL 49035-221_86946ee9-b074-4020-a3ce-30ad5af353e6 49035-221 HUMAN OTC DRUG Hand Sanitizer Cranberry Tart Alcohol LIQUID TOPICAL 20140418 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL 49035-222_0c84f88d-2b27-49ff-b5e7-7c5fca574fd9 49035-222 HUMAN OTC DRUG Hand Sanitizer Sugar Coated Plum Alcohol LIQUID TOPICAL 20140418 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL 49035-223_5f0d41bd-5df5-4416-ad36-8389d475aeca 49035-223 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20140630 OTC MONOGRAPH FINAL part341 EQUATE (Walmart Stores, Inc.) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 49035-224_a11b114e-8d44-40ac-950e-c5551966e646 49035-224 HUMAN OTC DRUG Equate anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030214 ANDA ANDA075232 Wal-Mart Stores Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 49035-226_0ad1482c-901d-44bc-b157-a95ad5eb2fd2 49035-226 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19921121 OTC MONOGRAPH FINAL part340 Wal-Mart Stores Inc CAFFEINE 200 mg/1 49035-227_f422cde8-92a6-4186-8f76-b23a1bb2613e 49035-227 HUMAN OTC DRUG Equate Pain Reliever Extra Strength Acetaminophen TABLET, COATED ORAL 20060608 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 500 mg/1 49035-230_e27db65b-9f66-4e15-880e-b4ddac4c82f9 49035-230 HUMAN OTC DRUG Nighttime Sleep Aid maximum strength Diphenhydramine HCl CAPSULE ORAL 20100706 OTC MONOGRAPH FINAL part341 EQUATE (Walmart Stores, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 49035-235_1251a20a-de37-4713-bf79-f94fd826a1cf 49035-235 HUMAN OTC DRUG Extra Strength Acetaminophen PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 49035-236_0055e6ef-2e24-434f-b9dd-40edcd544ddd 49035-236 HUMAN OTC DRUG Sleep Aid maximum strength DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 EQUATE (Walmart Stores, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 49035-237_41416b30-84d0-4a6a-b617-cc3476aee96d 49035-237 HUMAN OTC DRUG NIGHTTIME SLEEP AID Maximum Strength DIPHENHYDRAMINE HYDROCHLORIDE 50 mg CAPSULE, LIQUID FILLED ORAL 20131031 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 49035-238_78728f70-bdd8-43a1-b0ad-2a2f6d608bfc 49035-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130830 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM 100 mg/1 49035-240_92098f94-aaae-41aa-b3c6-a2d491ce0848 49035-240 HUMAN OTC DRUG Maximum Strength One Step Wart Remover Strips Maximum Strength One Step Wart Remover Strips with Salicylic Acid PLASTER TOPICAL 20130801 OTC MONOGRAPH FINAL part358B Wal-Mart Stores, Inc. SALICYLIC ACID .4 g/g 49035-242_08253157-e9ad-404c-8864-343f99f1c1d3 49035-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131015 OTC MONOGRAPH FINAL part347 EQUATE (Walmart Stores, Inc.) DIMETHICONE 125 mg/1 49035-244_53dc277a-abc5-4217-90dc-42e0c7502a02 49035-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM 100 mg/1 49035-247_dee2f47f-32fb-416f-b09b-294027fc21c3 49035-247 HUMAN OTC DRUG equate sinus night time Acetaminophen, Doxylamine Succinate, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20100804 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 49035-248_63a4ee97-ab64-47b8-8463-3af893dfc2d2 49035-248 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20131230 ANDA ANDA079174 EQUATE (Walmart Stores, Inc.) IBUPROFEN 200 mg/1 49035-251_644a7761-7fdd-43b3-aa79-94d7a7c5cba9 49035-251 HUMAN OTC DRUG arthricream Trolamine Salicylate CREAM TOPICAL 20090425 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc TROLAMINE SALICYLATE 10 g/100g 49035-255_7674cdac-bbe1-40fe-8f9b-a9d4795c4262 49035-255 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140430 ANDA ANDA091353 EQUATE (Walmart Stores, Inc.) NAPROXEN SODIUM 220 mg/1 49035-258_e91cb62c-f88d-429f-9857-e2591799028e 49035-258 HUMAN OTC DRUG STOOL SOFTENER Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM 250 mg/1 49035-268_0a0c2da1-73ce-46be-a389-88bde51ac0e7 49035-268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part356 EQUATE (Walmart Stores, Inc.) HYDROGEN PEROXIDE 2.65 mL/100mL 49035-274_d5270fff-5650-4190-9bf1-f8d36a43504d 49035-274 HUMAN OTC DRUG equate aspirin chewable Aspirin TABLET, CHEWABLE ORAL 20030306 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ASPIRIN 81 mg/1 49035-275_288a6dd9-908f-4d1d-895b-13486eb30fc4 49035-275 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part333A EQUATE (Walmart Stores, Inc.) ISOPROPYL ALCOHOL 70 mL/100mL 49035-276_658afd69-c3f2-409f-8076-d899d4d9c25a 49035-276 HUMAN OTC DRUG Equate Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Wal-Mart Stores Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 49035-277_0bf71051-b55a-49ec-9b2d-afdcc3a7554d 49035-277 HUMAN OTC DRUG Isopropyl alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part333A EQUATE (Walmart Stores, Inc.) ISOPROPYL ALCOHOL 91 mL/100mL 49035-279_a2251a3f-c915-4234-b788-2866a851553b 49035-279 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores, Inc BENZALKONIUM CHLORIDE 1.3 g/mL 49035-281_e2d7e0e0-66ca-457b-8a5b-9ffbec9c1d78 49035-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090105 OTC MONOGRAPH FINAL part358H Wal-Mart Stores, Inc PYRITHIONE ZINC 1 kg/100L 49035-281_ffc861ed-8929-4aad-9067-b584cc965f8e 49035-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090105 OTC MONOGRAPH FINAL part358H Wal-Mart Stores, Inc PYRITHIONE ZINC 1 kg/100L 49035-289_efeb65e6-dde8-41fd-a457-2cbe1e9f712c 49035-289 HUMAN OTC DRUG equate acetaminophen Acetaminophen SUSPENSION/ DROPS ORAL 19940825 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 80 mg/.8mL 49035-291_d928a8b0-b6f9-4ebc-8a03-e723d8f9dc67 49035-291 HUMAN OTC DRUG equate anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 19950322 UNAPPROVED DRUG OTHER Wal-Mart Stores Inc DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 49035-294_fc098482-eebb-4990-ab17-2df6601027a7 49035-294 HUMAN OTC DRUG equate hair regrowth treatment Minoxidil AEROSOL, FOAM TOPICAL 20120301 ANDA ANDA091344 Wal-Mart Stores Inc MINOXIDIL 5 g/100g 49035-296_845b1bdd-ac6d-4d98-9c4b-03c71d8ded27 49035-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 19980324 OTC MONOGRAPH FINAL part358H Wal-Mart Stores, Inc. PYRITHIONE ZINC 1 kg/100L 49035-298_af334373-bc70-48f2-93c6-99dcf2712373 49035-298 HUMAN OTC DRUG EQUATE SPRING SHOWERS ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC. TRICLOSAN 1.5 mg/mL 49035-299_8c96b2e9-0388-4eac-bca7-a18be30dd479 49035-299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 20080222 OTC MONOGRAPH NOT FINAL part356 Wal-Mart Stores, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL 49035-301_52356e33-4fe9-4dba-b6e6-65124e4ec255 49035-301 HUMAN OTC DRUG Blackhead Clearing Scrug Salicylic acid GEL TOPICAL 20070813 OTC MONOGRAPH FINAL part333D Wal Mart SALICYLIC ACID 19.4 mg/g 49035-302_33171fb3-a493-419f-9b20-675aa90aabb1 49035-302 HUMAN OTC DRUG equate stomach relief regular strength Bismuth subsalicylate LIQUID ORAL 19891215 OTC MONOGRAPH FINAL part335 Wal-Mart Stores Inc BISMUTH SUBSALICYLATE 262 mg/15mL 49035-304_3b040c6c-1678-459d-9231-613de56dafd3 49035-304 HUMAN OTC DRUG equate nasal original oxymetazoline hydrochloride SPRAY NASAL 19900815 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 49035-306_997045e2-e79f-4ef5-94a8-39f96c6eecc6 49035-306 HUMAN OTC DRUG equate clear lax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091008 ANDA ANDA090685 Wal-Mart Stores Inc POLYETHYLENE GLYCOL 3350 17 g/17g 49035-310_0bac12b1-7e2c-4e44-99db-c203b0b967e5 49035-310 HUMAN OTC DRUG Equate Tussin Adult Chest Congestion Guaifenesin SYRUP ORAL 20000725 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc GUAIFENESIN 100 mg/5mL 49035-311_a3a750ba-4564-4327-9bf4-5f6fce0307a1 49035-311 HUMAN OTC DRUG Everyday Clean Pyrithione zinc SHAMPOO TOPICAL 20100709 OTC MONOGRAPH FINAL part358H Wal-Mart Stores, Inc PYRITHIONE ZINC 10 mg/mL 49035-313_72d7e18f-5ddc-4f39-bac1-c7735b70f906 49035-313 HUMAN OTC DRUG Equate Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20131208 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/5mL 49035-317_e4eb9f24-aed5-497d-b826-378d32edbde5 49035-317 HUMAN OTC DRUG EQUATE MAXIMUM STRENGTH CREAMY DIAPER RASH RELIEF ZINC OXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part347 Wal-Mart Stores, Inc. ZINC OXIDE 181.6 g/454g 49035-318_6dd6f6a4-d159-4068-bce1-b63ee8d40b9a 49035-318 HUMAN OTC DRUG Antiseptic EUCALYPTOL RINSE ORAL 19920727 OTC MONOGRAPH NOT FINAL part356 Wal-Mart Stores, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 49035-319_910fe4b9-71b6-46f7-83e3-3c1c518877d6 49035-319 HUMAN OTC DRUG EQUATE CREAMY DIAPER RASH RELIEF ZINC OXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part347 Wal-Mart Stores, Inc. ZINC OXIDE 59.02 g/454g 49035-321_99bcedfb-1cb8-4252-8381-8ce4389beec1 49035-321 HUMAN OTC DRUG equate dual action complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080808 ANDA ANDA077355 Wal-Mart Stores Inc CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 49035-326_0b72f53a-d91a-4a9e-b8d6-ea5d91165b96 49035-326 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20000901 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc BISACODYL 5 mg/1 49035-327_cab4cdb5-6333-455f-86bb-4b98f9cad8a5 49035-327 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET, DELAYED RELEASE ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc BISACODYL 5 mg/1 49035-328_c82cd03c-c82a-46fa-bb08-c68ee810eb7f 49035-328 HUMAN OTC DRUG Equate Sore Throat Phenol SPRAY ORAL 20050628 OTC MONOGRAPH NOT FINAL part356 Wal-Mart Stores Inc PHENOL 1.4 g/100mL 49035-329_1029777e-0237-4ae2-a1f6-00bcd241066f 49035-329 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20141031 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) MAGNESIUM CITRATE 1.745 g/29.6mL 49035-331_8945c9ce-28dc-4891-9185-7e797e4afaed 49035-331 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20131101 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) MAGNESIUM CITRATE 1.745 g/29.6mL 49035-334_7610c89f-494d-45fc-87a2-d590511494c4 49035-334 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin and Caffeine TABLET, FILM COATED ORAL 20080313 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 49035-335_7796b9ff-9e49-471a-aa72-03e72ab367c9 49035-335 HUMAN OTC DRUG equate nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110806 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 49035-337_3cfe6d88-8e92-402a-970b-fcddf2b0cd4d 49035-337 HUMAN OTC DRUG equate stomach relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 20010202 OTC MONOGRAPH FINAL part335 Wal-Mart Stores Inc BISMUTH SUBSALICYLATE 1050 mg/30mL 49035-339_e7aca0d0-a96a-4a86-b700-aa5c09a55a38 49035-339 HUMAN OTC DRUG Miconazole Nitrate Jock Itch Powder Spray AEROSOL, POWDER TOPICAL 20140225 OTC MONOGRAPH FINAL part333C Wal-Mart Stores, Inc. MICONAZOLE NITRATE 2.6 g/130g 49035-340_97962f07-9b82-42a1-857a-75846fbf5688 49035-340 HUMAN OTC DRUG Equate antacid maximum strength aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 19930720 OTC MONOGRAPH FINAL part331 Wal-Mart Stores Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 49035-341_745242b5-c10f-4c59-8037-e7e0e4c948d6 49035-341 HUMAN OTC DRUG equate athletes foot Miconazole Nitrate SPRAY TOPICAL 20110918 OTC MONOGRAPH FINAL part333C Wal-Mart Stores Inc MICONAZOLE NITRATE 2 g/100g 49035-342_381d2adb-8dd7-4ca2-82c7-c8578abea553 49035-342 HUMAN OTC DRUG Equate Liquid Foot Tolnaftate SPRAY TOPICAL 20140701 OTC MONOGRAPH FINAL part333C Wal-Mart Stores, Inc TOLNAFTATE 1 g/150g 49035-344_e6edc5dc-7e4f-4b12-b7a4-ca3577b001ed 49035-344 HUMAN OTC DRUG Kids Anticavity Post-Brush Fluoride Rinse AnticavityFluoride MOUTHWASH ORAL 20090820 OTC MONOGRAPH FINAL part355 Wal-Mart Stores, Inc. SODIUM FLUORIDE .0221 kg/100L 49035-346_9d83d904-a507-41ae-a60b-92281d324000 49035-346 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate CAPSULE ORAL 20110506 OTC MONOGRAPH FINAL part335 Wal-Mart Stores Inc BISMUTH SUBSALICYLATE 262 mg/1 49035-348_9a578e3f-c545-46b8-9dd5-8cb0bd89f6f1 49035-348 HUMAN OTC DRUG Laxative Sennosides TABLET ORAL 20030104 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc SENNOSIDES A AND B 25 mg/1 49035-350_4552c571-a168-4f8a-8d29-71ecfb575425 49035-350 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, EXTENDED RELEASE ORAL 20130805 ANDA ANDA078569 Wal-Mart Stores, Inc ACETAMINOPHEN 650 mg/1 49035-351_ab07997b-6468-4ff8-88ef-080a28bb0dbe 49035-351 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20130909 ANDA ANDA200536 Wal-Mart Stores, Inc RANITIDINE HYDROCHLORIDE 150 mg/1 49035-352_ed3b5973-9d44-4fdd-a48f-8af8525edcb7 49035-352 HUMAN OTC DRUG Equate nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20081014 ANDA ANDA078547 Wal-Mart Stores Inc NICOTINE 2 mg/1 49035-353_dc9593b0-974d-4922-85a1-a454c7472dfe 49035-353 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20120710 ANDA ANDA201745 Wal-Mart Stores, Inc RANITIDINE HYDROCHLORIDE 75 mg/1 49035-357_28843406-63d6-4521-b490-47ac8a1a6a77 49035-357 HUMAN OTC DRUG Equate Antacid regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19900615 OTC MONOGRAPH FINAL part331 Wal-Mart Stores Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 49035-359_b3d75cf6-7c33-4c9c-8a19-fffc6d12f87d 49035-359 HUMAN OTC DRUG Equate Tussin DM adult Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 19920603 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 49035-365_69146ba2-11af-4b1b-ac97-3a8df8653775 49035-365 HUMAN OTC DRUG equate nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20111004 ANDA ANDA091349 Wal-Mart Stores Inc NICOTINE 2 mg/1 49035-368_7c4ac91a-ac45-44d2-8d37-fe5ba64df301 49035-368 HUMAN OTC DRUG equate naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20070427 ANDA ANDA074661 Wal-Mart Stores Inc NAPROXEN SODIUM 220 mg/1 49035-370_d6a767a9-c40b-42d5-8a97-2ea40f3ae1f7 49035-370 HUMAN OTC DRUG Aspirin regular strength Aspirin TABLET, COATED ORAL 20131025 OTC MONOGRAPH FINAL part343 EQUATE (Walmart Stores, Inc.) ASPIRIN 325 mg/1 49035-371_4a6973d6-5a5d-445f-8816-990af4c1828b 49035-371 HUMAN OTC DRUG Stomach Relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part335 EQUATE (Walmart Stores, Inc.) BISMUTH SUBSALICYLATE 1050 mg/30mL 49035-374_2dc503fc-7530-47c4-9bcb-c6b9677b29ed 49035-374 HUMAN OTC DRUG equate migraine relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20020416 ANDA ANDA075794 Wal-Mart Stores Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 49035-375_8116d1c5-0cee-4a98-a1be-0aeee11b7c51 49035-375 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl CAPSULE ORAL 20050503 ANDA ANDA076497 Wal-Mart Stores Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 49035-376_6d8efd00-b9c6-48ac-8688-d69a7b9b0af2 49035-376 HUMAN OTC DRUG Sore Throat Phenol SPRAY ORAL 20140731 OTC MONOGRAPH NOT FINAL part356 EQUATE (Walmart Stores, Inc.) PHENOL 1.4 g/100mL 49035-379_a0056a5c-d97e-4ca8-a25a-6e1688d637c6 49035-379 HUMAN OTC DRUG equate allergy relief Diphenhydramine Hydrochloride LIQUID ORAL 19900815 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 49035-380_fb049417-d9b3-4151-86d1-f59e4c0ea6ee 49035-380 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 20120413 OTC MONOGRAPH FINAL part334 Wal-Mart Stores Inc MAGNESIUM CITRATE 1.745 g/29.6mL 49035-383_35ac039a-3038-4100-b9e7-125fe59cef3c 49035-383 HUMAN OTC DRUG Foaming Hand Wash Antibacterial Triclosan LIQUID TOPICAL 19930319 OTC MONOGRAPH NOT FINAL part333A Wal-Mart TRICLOSAN 6 mg/mL 49035-384_cec22c78-70b3-4983-ba40-c255db4cf66d 49035-384 HUMAN OTC DRUG Equate Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120829 ANDA ANDA091135 Wal-Mart Stores Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 49035-386_65553725-a467-43ce-a564-b0b8e9faaaa1 49035-386 HUMAN OTC DRUG Extra Strength Medicated Body Dimethicone LOTION TOPICAL 19950117 OTC MONOGRAPH FINAL part347 Wal-Mart Stores, Inc DIMETHICONE; MENTHOL 5; .5 kg/100kg; kg/100kg 49035-388_c38a2783-aed9-466d-8976-59d03a792c04 49035-388 HUMAN OTC DRUG Equate Nasal Oxymetazoline HCl SPRAY NASAL 20070727 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 49035-390_701e7ed7-f6af-4886-b344-f793ec6ba099 49035-390 HUMAN OTC DRUG Menstrual Complete Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 49035-393_21166413-1f28-458d-9f45-397669e0f26b 49035-393 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, COATED ORAL 20020408 ANDA ANDA075139 Wal-Mart Stores Inc IBUPROFEN 200 mg/1 49035-394_1d5deb64-2219-4255-ad68-8e3f111c14bd 49035-394 HUMAN OTC DRUG Equate hemorrhoidal Cocoa butter, Phenylephrine HCl, Shark liver oil SUPPOSITORY RECTAL 19980306 OTC MONOGRAPH FINAL part346 Wal-Mart Stores Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2137.5; 75; 6.375 mg/1; mg/1; mg/1 49035-396_a976cbbf-f98c-367a-7521-6486f18af0c8 49035-396 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20111104 ANDA ANDA077367 Walmart Stores Inc. FAMOTIDINE 20 mg/1 49035-397_fe6f5fc1-c151-984d-36d8-38a95fea0643 49035-397 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium 20.6mg Capsules CAPSULE, DELAYED RELEASE ORAL 20100115 ANDA ANDA078878 Wal-Mart Stores Inc OMEPRAZOLE MAGNESIUM 20 mg/1 49035-400_adbb8362-fc67-4e29-91c3-d42fad796a87 49035-400 HUMAN OTC DRUG Equate Hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 19960105 OTC MONOGRAPH FINAL part346 Wal-Mart Stores Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 49035-401_b1527f14-c1fa-4ef6-a880-5d1a96c22c12 49035-401 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET ORAL 20130930 OTC MONOGRAPH FINAL part338 EQUATE (Walmart Stores, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49035-403_3777bbcd-17d2-4887-a372-d5197c91cbdf 49035-403 HUMAN OTC DRUG Less Drowsy Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 Wal-Mart Stores Inc MECLIZINE HYDROCHLORIDE 25 mg/1 49035-404_3693cc0e-7683-b24c-60f9-9b0804b8fd64 49035-404 HUMAN OTC DRUG Ranitidine 150 Ranitidine Hydrochloride Tablets 150mg TABLET, COATED ORAL 20100105 ANDA ANDA078192 Walmart Stores Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 49035-407_774bc1bf-4b40-4f63-9e1d-17956b0a64f2 49035-407 HUMAN OTC DRUG equate arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110719 ANDA ANDA075077 Wal-Mart Stores Inc ACETAMINOPHEN 650 mg/1 49035-411_3eb7a657-625a-46bf-a196-4ba6aa41a7bf 49035-411 HUMAN OTC DRUG equate lansoprazole delayed release Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20140505 ANDA ANDA202319 Wal-Mart Stores Inc LANSOPRAZOLE 15 mg/1 49035-414_f31672c8-3918-4746-bf27-22bf63a7b485 49035-414 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID ORAL; TOPICAL 20091110 OTC MONOGRAPH NOT FINAL part356 Walmart HYDROGEN PEROXIDE 2.65 mL/100mL 49035-416_9efcacef-71fe-4873-9036-d3f3c0ad2c0a 49035-416 HUMAN OTC DRUG Equate Aspirin Aspirin TABLET ORAL 19900215 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ASPIRIN 325 mg/1 49035-422_f9d15a3f-e2ed-4ebf-9f79-710cb4cb92d2 49035-422 HUMAN OTC DRUG equate nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050308 ANDA ANDA078326 Wal-Mart Stores Inc NICOTINE 4 mg/1 49035-426_6b3ee10a-d945-41f4-bbb5-ff2e2fdcd22c 49035-426 HUMAN OTC DRUG Equate tioconazole 1 day Tioconazole OINTMENT VAGINAL 20071101 ANDA ANDA075915 Wal-Mart Stores Inc TIOCONAZOLE 6.5 g/100g 49035-427_d3a5c2cd-8f2a-4801-8e34-c5884f30f770 49035-427 HUMAN OTC DRUG EQUATE EVERYDAY CLEAN PYRITIONE ZINC LIQUID TOPICAL 20131127 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC PYRITHIONE ZINC 10 mg/mL 49035-430_873a072f-159b-44b8-aad8-33963d961afb 49035-430 HUMAN OTC DRUG Eye Allergy Relief Pheniramine Maleate and Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20100831 NDA NDA020065 Wal-Mart Stores Inc NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL 49035-431_6bfd45c1-772b-404d-982b-4f012f581713 49035-431 HUMAN OTC DRUG equate nighttime sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20000516 OTC MONOGRAPH FINAL part338 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49035-439_0d6fd00c-7295-4a98-9ab3-21f345f12a1b 49035-439 HUMAN OTC DRUG Equate Face Octinoxate and Oxybenzone LOTION TOPICAL 20101231 OTC MONOGRAPH NOT FINAL part352 Wal-Mart Stores Inc OCTINOXATE; OXYBENZONE 7.5; 5 mg/100mL; mg/100mL 49035-441_bfbd92b7-2fd4-4556-ac7c-33ec54fe4931 49035-441 HUMAN OTC DRUG Equate sleep aid Doxylamine succinate TABLET ORAL 19970225 ANDA ANDA040167 Wal-Mart Stores Inc DOXYLAMINE SUCCINATE 25 mg/1 49035-442_ffd84558-8ef3-4263-8119-fdd167b2fa69 49035-442 HUMAN OTC DRUG equate Nicotine Nicotine polacrilex GUM, CHEWING ORAL 19900615 ANDA ANDA091354 Wal-Mart Stores Inc NICOTINE 4 mg/1 49035-445_57615ce4-9cdd-4807-a17a-97b0dec33b68 49035-445 HUMAN OTC DRUG Equate Flu and Severe Cold and Cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20140205 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 49035-447_9401b876-9f74-4cd2-a847-f307f50b1542 49035-447 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20050203 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 80 mg/1 49035-449_3c75ca4e-49e0-4379-8f77-4ee036ea16c4 49035-449 HUMAN OTC DRUG Junior Acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/1 49035-452_e2d01237-7ff8-4108-9701-fa043876c068 49035-452 HUMAN OTC DRUG Hand Sanitizer Bodycology Ethyl Alcohol GEL TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores, Inc. ALCOHOL 70 mL/100mL 49035-453_eb1d55bd-fba2-4216-a6ae-eb0240b0b2ce 49035-453 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine HCl TABLET, COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 49035-454_8623d6a5-1ab2-49f9-8bac-55a48f35cfa4 49035-454 HUMAN OTC DRUG Artifical Tears Glycerin and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20100901 OTC MONOGRAPH FINAL part349 Wal-Mart Stores Inc GLYCERIN; PROPYLENE GLYCOL 3; 10 mg/mL; mg/mL 49035-456_93d47973-6d07-46a6-abb6-4adb0f6705a4 49035-456 HUMAN OTC DRUG Equate Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070509 ANDA ANDA076777 Wal-Mart Stores Inc NICOTINE 2 mg/1 49035-458_b33eb97f-5ac3-4eb7-b23a-cf550ce46287 49035-458 HUMAN OTC DRUG equate allergy relief Cetirizine Hydrochloride TABLET ORAL 20080109 ANDA ANDA078336 Wal-Mart Stores Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 49035-459_c344ffad-a8db-4c82-8113-2829961c98ee 49035-459 HUMAN OTC DRUG equate nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110802 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 49035-460_11c133e0-2e44-4a0e-be79-9553a93f2f3b 49035-460 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20090922 OTC MONOGRAPH NOT FINAL part334 Walmart MINERAL OIL 15 mL/15mL 49035-462_135fc013-d843-4717-9d4b-733a8d01ed06 49035-462 HUMAN OTC DRUG Suphedrine PE Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20050609 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 49035-463_9591cdec-703f-4ed6-b924-298ac7cc8651 49035-463 HUMAN OTC DRUG equate hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140523 OTC MONOGRAPH FINAL part346 Wal-Mart Stores Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 49035-464_3bde188b-8cbf-4c54-bf69-1a5265d6c1fd 49035-464 HUMAN OTC DRUG Allergy and Sinus Headache Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET ORAL 20050615 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 49035-467_c56dcfe4-a700-45fe-ace9-bf95237d4806 49035-467 HUMAN OTC DRUG equate aspirin Aspirin TABLET, CHEWABLE ORAL 20030319 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ASPIRIN 81 mg/1 49035-471_bd7246fd-f445-4aa5-871b-58c6348d6c65 49035-471 HUMAN OTC DRUG Equate Hydrocortisone hydrocortisone OINTMENT TOPICAL 20130221 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc HYDROCORTISONE 1 g/100g 49035-477_70bc6870-3750-4753-b137-feef6d390ca3 49035-477 HUMAN OTC DRUG Equate fiber therapy Calcium polycarbophil TABLET, FILM COATED ORAL 19961105 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc CALCIUM POLYCARBOPHIL 625 mg/1 49035-479_d4057d13-0b7f-427d-922b-baae3c04aea9 49035-479 HUMAN OTC DRUG equate allergy relief Diphenhydramine Hydrochloride TABLET ORAL 19990730 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49035-482_87648b9f-1ec3-451d-b78c-62daedaea5ef 49035-482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20131227 OTC MONOGRAPH FINAL part355 Wal-Mart Stores, Inc SODIUM FLUORIDE .1 mg/mL 49035-484_99328ad8-a4e4-4d9a-b6db-669112251862 49035-484 HUMAN OTC DRUG equate acetaminophen Acetaminophen TABLET ORAL 19890915 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 500 mg/1 49035-485_7748268a-c5a3-4727-b434-544057b1e2ed 49035-485 HUMAN OTC DRUG Equate antacid regular strength calcium carbonate TABLET, CHEWABLE ORAL 19930719 OTC MONOGRAPH FINAL part331 Wal-Mart Stores Inc CALCIUM CARBONATE 500 mg/1 49035-489_76f4ce90-3f77-4c80-8e3d-252dd9aa92fc 49035-489 HUMAN OTC DRUG equate antacid Calcium carbonate TABLET, CHEWABLE ORAL 20050421 OTC MONOGRAPH FINAL part331 Wal-Mart Stores Inc CALCIUM CARBONATE 750 mg/1 49035-490_c7445973-7ae8-427c-88e2-27827f5c3c37 49035-490 HUMAN OTC DRUG equate naproxen sodium Naproxen Sodium TABLET ORAL 20070502 ANDA ANDA074661 Wal-Mart Stores Inc NAPROXEN SODIUM 220 mg/1 49035-497_eaccd29d-9519-481f-878d-f1e9b294329d 49035-497 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20110831 OTC MONOGRAPH FINAL part358H Wal-Mart COAL TAR 1 g/100mL 49035-498_6d12e694-fbb6-4018-85f2-06d3719ded6f 49035-498 HUMAN OTC DRUG Equate Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130322 ANDA ANDA078912 Wal-Mart Stores Inc GUAIFENESIN 600 mg/1 49035-499_44842382-685e-4133-9cb5-a8068fb46497 49035-499 HUMAN OTC DRUG equate Athletes Foot Tolnaftate CREAM TOPICAL 20060217 OTC MONOGRAPH FINAL part333C Wal-Mart Stores Inc TOLNAFTATE 10 mg/g 49035-502_3850fb37-1da2-4770-bf1f-0983c52b37b6 49035-502 HUMAN OTC DRUG Suphedrine PE Acetaminophen and Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 49035-503_6ce02a19-b737-44d8-bedd-f29de34fcccb 49035-503 HUMAN OTC DRUG Severe Cold Multi-Symptom Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED ORAL 20050804 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 49035-511_1c6beeb0-9309-45f0-9ec7-a71e1b66d07e 49035-511 HUMAN OTC DRUG equate first aid antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20140612 OTC MONOGRAPH FINAL part333B Wal-Mart Stores Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 49035-515_02924218-124f-46f5-b241-511b36174b83 49035-515 HUMAN OTC DRUG equate daytime nitetime Acetaminophen, Doxylamine succinate , Phenylephrine HCl KIT 20070803 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc 49035-515_e6f54ca8-7d8b-4365-9d5f-d1e06a612f83 49035-515 HUMAN OTC DRUG equate daytime nitetime Acetaminophen, Doxylamine succinate , Phenylephrine HCl KIT 20120911 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc 49035-515_f540b4e7-ba66-48d0-93a9-eb9ad3f55e67 49035-515 HUMAN OTC DRUG equate daytime nitetime Acetaminophen, Doxylamine succinate , Phenylephrine HCl KIT 20110608 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc 49035-516_6ba96b3e-beb5-42c0-852e-516829a5fc32 49035-516 HUMAN OTC DRUG Equate Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20060310 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 49035-519_6b15026d-bb71-4626-bcbe-9cda582d6c35 49035-519 HUMAN OTC DRUG Extra Strength Acetaminophen Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 500 mg/1 49035-520_2a7e8ac5-05b5-4bec-889f-10e145df9fc9 49035-520 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20130115 NDA NDA021855 EQUATE (Walmart Stores, Inc.) LOPERAMIDE HYDROCHLORIDE 2 mg/1 49035-521_11cc7d60-8869-4576-8c63-d6d745a3daaf 49035-521 HUMAN OTC DRUG equate ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20111025 ANDA ANDA076359 Wal-Mart Stores Inc IBUPROFEN 100 mg/1 49035-522_ae74eb4a-6344-4067-9706-cae79c62450e 49035-522 HUMAN OTC DRUG EQUATE MOISTURIZING DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20140817 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC SELENIUM SULFIDE 10 mg/mL 49035-523_d996aa7c-b00a-4d9e-842c-d7ea8223b80f 49035-523 HUMAN OTC DRUG Equate Acetaminophen Acetaminophen TABLET ORAL 19890915 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 325 mg/1 49035-525_d1403e49-3eb1-41ed-8d9d-8a7444a26836 49035-525 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19950829 OTC MONOGRAPH FINAL part334 Wal-Mart Stores, Inc MAGNESIUM CITRATE 1.745 g/29.6mL 49035-527_578dd8d0-9252-4a5b-98e9-c7d9ce34107d 49035-527 HUMAN OTC DRUG Severe Sinus Congestion and Pain Aceetaminophen, Guaifenesin and Phenylephrine HCl TABLET ORAL 20050806 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 49035-529_b950c810-b158-429b-adb3-540a332359b4 49035-529 HUMAN OTC DRUG Multi-Symptom Cold Relief Acetaminophen, Chlorpehniramine HCl, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc 49035-530_b54afe54-7e47-4438-9785-6dddafdf9185 49035-530 HUMAN OTC DRUG GAS RELIEF Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20130115 OTC MONOGRAPH FINAL part332 EQUATE (Walmart Stores, Inc.) DIMETHICONE 180 mg/1 49035-531_5a5e69c7-99db-46c7-a4ed-cc673a1e6a66 49035-531 HUMAN OTC DRUG Extra Strength Acetaminophen Acetaminophen TABLET ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 500 mg/1 49035-532_0d727fbd-67dc-4a9e-9171-11d1287d03a0 49035-532 HUMAN OTC DRUG Equate nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070509 ANDA ANDA076779 Wal-Mart Stores Inc NICOTINE 4 mg/1 49035-541_1747a304-342c-491f-867a-f0290f98cdb2 49035-541 HUMAN OTC DRUG equate hydrocortisone Hydrocortisone CREAM TOPICAL 20050629 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc HYDROCORTISONE 1 g/100g 49035-543_b51dd3e9-0124-4fa3-9e9c-eb72d1d463d7 49035-543 HUMAN OTC DRUG Severe Allergy And Sinus Headache Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET ORAL 20070627 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 49035-544_bf48a713-a12b-4567-b6f2-8b3733bcaaf1 49035-544 HUMAN OTC DRUG Equate arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000516 ANDA ANDA075077 Wal-Mart Stores Inc ACETAMINOPHEN 650 mg/1 49035-546_277de83d-ce6b-4d5e-b039-44cad9ebaaa8 49035-546 HUMAN OTC DRUG Equate Complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080808 ANDA ANDA077355 Wal-Mart Stores Inc CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 49035-548_24a4561c-31cc-4a19-b287-57466ee30ae3 49035-548 HUMAN OTC DRUG equate daytime severe acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140727 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 49035-550_b9c4f926-a69f-4003-b667-fda9d43174cd 49035-550 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100706 OTC MONOGRAPH FINAL part332 EQUATE (Walmart Stores, Inc.) DIMETHICONE 125 mg/1 49035-551_ff95b2b1-48e6-4306-aa68-31148ac6dd4a 49035-551 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20030731 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores,Inc MENTHOL; ZINC OXIDE 1.5; 10 mg/g; mg/g 49035-553_9c2e57d3-e04b-42ee-bf58-392454598532 49035-553 HUMAN OTC DRUG Equate Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130813 ANDA ANDA072096 Wal-Mart Stores Inc IBUPROFEN 200 mg/1 49035-555_79473c2f-9ef4-4104-ae67-6f28b262f0b7 49035-555 HUMAN OTC DRUG Mucus Relief Chest Guaifenesin TABLET ORAL 20051222 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc GUAIFENESIN 400 mg/1 49035-556_33c4e3e9-cce0-4a79-9eaa-01d0fa10a416 49035-556 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 49035-558_58a066db-41b7-4bcf-9df4-43a3d92cf57f 49035-558 HUMAN OTC DRUG Sinus Congestion and Pain Acetaminophen and Phenylephrine HCl CAPSULE ORAL 20080317 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 49035-559_dc856a8c-ab62-4758-9531-1f2399b53c0b 49035-559 HUMAN OTC DRUG Rapid Release Multi-Symptom Allergy Relief Acetaminophen, Phenylephrine HCl, Chlorpheniramine maleate CAPSULE, GELATIN COATED ORAL 20080317 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 49035-560_aa88913e-969d-4b9a-bca9-49b0d8e40a47 49035-560 HUMAN OTC DRUG Cold Multi-Symptom Daytime Acetaminophen, Phenylephrine HCl and Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20080329 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 49035-561_3c156867-766e-4acb-aaae-6bfc995524e3 49035-561 HUMAN OTC DRUG Cold and Sinus Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET ORAL 20130407 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 49035-563_318a88fe-10f0-441e-a3b0-e02f81de19b8 49035-563 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ASPIRIN 81 mg/1 49035-565_52dd8ecc-3ac1-4123-ae6c-dec30a4ccb9c 49035-565 HUMAN OTC DRUG equate sinus day time Acetaminophen, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20070803 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 49035-568_c7ac0431-c154-4033-9264-12f83ac695e1 49035-568 HUMAN OTC DRUG Bodycology Brown Sugar Vanilla Ethyl Alcohol GEL TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores, Inc. ALCOHOL 70 mL/100mL 49035-571_d523553a-67ab-4b66-8ea6-155a70b5a821 49035-571 HUMAN OTC DRUG equate allergy relief fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Wal-Mart Stores Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 49035-578_5faeca0d-864f-4e15-a992-66e0746759ef 49035-578 HUMAN OTC DRUG Childrens Allergy Relief Cetirizine HCl TABLET, CHEWABLE ORAL 20081031 ANDA ANDA077946 Wal-Mart Stores Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 49035-580_899409f7-48c7-4ae9-abc6-fe8d4c91da3b 49035-580 HUMAN OTC DRUG Equate DayTime NiteTime Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140507 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc 49035-582_177e80cf-18e9-4165-81c4-e1450c6e7b32 49035-582 HUMAN OTC DRUG equate vitamins a and d Lanolin, Petrolatum OINTMENT TOPICAL 20050629 OTC MONOGRAPH FINAL part347 Wal-Mart Stores Inc LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g 49035-590_b1d6ead8-43ae-4128-b615-1fd60271d9c1 49035-590 HUMAN OTC DRUG equate pain and fever acetaminophen SUSPENSION ORAL 19930317 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/5mL 49035-595_3cd5b904-5168-4d00-9700-10db5e934101 49035-595 HUMAN OTC DRUG equate antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20050421 OTC MONOGRAPH FINAL part331 Wal-Mart Stores Inc CALCIUM CARBONATE 1000 mg/1 49035-597_7b7afdfc-0f42-42fc-8354-ddfac2f620d7 49035-597 HUMAN OTC DRUG Equate DayTime NiteTime Severe acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140812 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc 49035-599_3ed34941-9600-49f1-ab51-4e04944abaf8 49035-599 HUMAN OTC DRUG Childrens Allergy Relief Diphenhydramine TABLET, ORALLY DISINTEGRATING ORAL 20110501 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 49035-604_996164c2-9f59-4317-94fe-2be5ad220dab 49035-604 HUMAN OTC DRUG equate ibuprofen Ibuprofen TABLET ORAL 19891015 ANDA ANDA072096 Wal-Mart Stores Inc IBUPROFEN 200 mg/1 49035-608_d1d188c9-3197-40a1-9efa-b3e1be06984d 49035-608 HUMAN OTC DRUG Equate Ranitidine Ranitidine TABLET, FILM COATED ORAL 20120212 ANDA ANDA091429 Wal-Mart Stores Inc RANITIDINE HYDROCHLORIDE 150 mg/1 49035-610_95e0bc76-6ea1-460c-8e2e-b1549f9feedb 49035-610 HUMAN OTC DRUG MEDICATED DANDRUFF MAXIMUM STRENGTH SELENIUM SULFIDE SHAMPOO TOPICAL 20110819 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC SELENIUM SULFIDE 1 mL/100mL 49035-612_1550cc5d-47b1-409f-8d60-8a8d7aa88063 49035-612 HUMAN OTC DRUG equate allergy relief Loratadine TABLET ORAL 20070427 ANDA ANDA076301 Wal-Mart Stores Inc LORATADINE 10 mg/1 49035-615_39da22d5-fbab-4430-bcd3-34424224e67d 49035-615 HUMAN OTC DRUG equate itchy eye Ketotifen SOLUTION OPHTHALMIC 20100909 ANDA ANDA077958 Wal-Mart Stores Inc KETOTIFEN FUMARATE .25 mg/mL 49035-616_86f53fc5-ee14-42ce-9c20-baf54180e09c 49035-616 HUMAN OTC DRUG Multi-Symptom Cold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET ORAL 20130407 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 49035-618_aca81965-1089-4051-8aae-75ba6b4ccf53 49035-618 HUMAN OTC DRUG EQUATE CRITICAL STRENGTH SELENIUM SULFIDE LIQUID TOPICAL 20120919 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC. SELENIUM SULFIDE 10 mg/mL 49035-619_411a4a10-9fd3-49f3-80df-404c8d2f8585 49035-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20100222 OTC MONOGRAPH FINAL part347 Wal-Mart Stores, Inc DIMETHICONE 13.13 mg/mL 49035-620_6d42e9f9-17e0-478c-b43c-34b95844dc06 49035-620 HUMAN OTC DRUG EQUATE SELENIUM SULFIDE LIQUID TOPICAL 20130621 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC. SELENIUM SULFIDE 10 mg/mL 49035-621_e057a277-3121-4c20-9e2b-df84ce069ec8 49035-621 HUMAN OTC DRUG EQUATE ALOE SELENIUM SULFIDE LIQUID TOPICAL 20131125 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC SELENIUM SULFIDE 10 mg/mL 49035-622_97a12fef-d5eb-453c-8c0d-6642f873ec82 49035-622 HUMAN OTC DRUG Equate Anti Itch Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20050629 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 49035-637_5d9e5081-38b5-449c-9d78-e6e2445e3d38 49035-637 HUMAN OTC DRUG Equate Naproxen Sodium Naproxen Sodium TABLET ORAL 20130911 ANDA ANDA074661 Wal-Mart Stores Inc NAPROXEN SODIUM 200 mg/1 49035-645_3bdd262c-5f42-4449-85d5-9de58b76da63 49035-645 HUMAN OTC DRUG Equate Loperamide Hydrochloride loperamide HCl SUSPENSION ORAL 20111007 ANDA ANDA091292 Wal-Mart Stores Inc LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 49035-647_3dd154fd-c29f-44fe-89ff-d3091d05492d 49035-647 HUMAN OTC DRUG equate ibuprofen Ibuprofen TABLET, COATED ORAL 19890915 ANDA ANDA072096 Wal-Mart Stores Inc IBUPROFEN 200 mg/1 49035-648_95ef1819-edc3-4dda-8514-85b61538cc72 49035-648 HUMAN OTC DRUG Equate Nasal Phenylephrine hydrochloride SPRAY NASAL 20020724 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 49035-650_8ac94821-aa78-4e57-bc9a-f1f2a0e47b07 49035-650 HUMAN OTC DRUG Equate Famotidine Famotidine TABLET ORAL 20070502 ANDA ANDA077351 Wal-Mart Stores Inc FAMOTIDINE 20 mg/1 49035-656_2abe1c11-e336-4858-a2a3-2d930af65b61 49035-656 HUMAN OTC DRUG Equate Day time cold and flu multi symptom relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20060608 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 49035-657_4e5307e9-4585-44f6-b065-674c9c97be3f 49035-657 HUMAN OTC DRUG Equate Revive Plus Lubricant Eye Carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20130905 OTC MONOGRAPH FINAL part349 Wal-Mart Stores Inc CARBOXYMETHYLCELLULOSE SODIUM .5 mg/10mg 49035-660_a7dd26df-9c39-44f8-b26b-fbb7f5e85707 49035-660 HUMAN OTC DRUG equate ibuprofen childrens Ibuprofen SUSPENSION ORAL 20100819 ANDA ANDA074937 Wal-Mart Stores Inc IBUPROFEN 100 mg/5mL 49035-664_e75cdda6-3fab-4468-ad03-cd7f2336b465 49035-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19920915 OTC MONOGRAPH NOT FINAL part356 Wal-Mart Stores, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 49035-667_80010e07-6cef-44b8-88f6-70ea5558a687 49035-667 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 20120321 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores, Inc MAGNESIUM CITRATE 1.745 g/29.61mL 49035-668_71f52f36-4cf6-4f2b-adc7-e820b466bb22 49035-668 HUMAN OTC DRUG Equate Nite Time Cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20020724 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 49035-678_4304ac49-2627-4f18-b3ae-48b7ef7bb0c5 49035-678 HUMAN OTC DRUG equate hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20121025 OTC MONOGRAPH FINAL part346 Wal-Mart Stores Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 49035-688_3b4b668e-03f5-4286-b0a6-67412768c173 49035-688 HUMAN OTC DRUG Age Control Anti-Sagging and Ultra Hydrating Day SPF 15 Ensulizole, Octinoxate CREAM TOPICAL 20131220 OTC MONOGRAPH NOT FINAL part352 Wal-Mart Stores, Inc. ENSULIZOLE; OCTINOXATE 1.7; 7.5 g/100g; g/100g 49035-692_e0439183-00bc-4aa9-bd05-2b24b1d43f64 49035-692 HUMAN OTC DRUG Equate Cool and Heat Menthol, Methyl salicylate CREAM TOPICAL 20130820 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g 49035-699_fc0a94b2-42b7-427a-8a0e-c26e55740a7e 49035-699 HUMAN OTC DRUG equate ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090415 ANDA ANDA079113 Wal-Mart Stores Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 49035-700_5ed1d7b3-925e-4a18-8e15-636f5b442ad7 49035-700 HUMAN OTC DRUG Equate Pain Relieving Ultra Strength Camphor, Menthol, Methyl salicylate CREAM TOPICAL 20110613 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 40; 10; 300 mg/g; mg/g; mg/g 49035-707_6cb2f362-4041-45b9-82e0-dfe26c043e24 49035-707 HUMAN OTC DRUG equate hydrocortisone Hydrocortisone CREAM TOPICAL 20120313 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc HYDROCORTISONE 1 g/100g 49035-719_5a5fadcb-1ad8-4f19-97b4-7726af068b13 49035-719 HUMAN OTC DRUG EQUATE MEDICATED DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20140817 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC SELENIUM SULFIDE 10 mg/mL 49035-721_1faaae1a-cd88-4611-8e33-b5e8664f91c4 49035-721 HUMAN OTC DRUG EQUATE LIGHT MOISTURIZERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131018 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC BENZALKONIUM CHLORIDE 1.3 mg/mL 49035-721_fc05845f-83a5-4ccb-a49d-d93d04bdc6f6 49035-721 HUMAN OTC DRUG EQUATE LIGHT MOISTURIZERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131018 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC BENZALKONIUM CHLORIDE 1.3 mg/mL 49035-722_621b7255-5930-43a1-b899-acbaa59568fc 49035-722 HUMAN OTC DRUG Regular Strength Aspirin Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ASPIRIN 325 mg/1 49035-723_94a0328c-0922-4818-89db-cde227869ac8 49035-723 HUMAN OTC DRUG EQUATE SPRING SHOWERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131018 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC BENZALKONIUM CHLORIDE 1.3 mg/mL 49035-724_1661e148-bdac-415b-9bad-49219a2ca41c 49035-724 HUMAN OTC DRUG EQUATE ANTIBACTERIAL HAND WITH MOISTURIZERS SPRING SHOWERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140817 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC BENZALKONIUM CHLORIDE 1.3 mg/mL 49035-730_833f7172-aec5-4052-8243-1f4f10f404ad 49035-730 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20080303 ANDA ANDA074164 Equate MICONAZOLE NITRATE 2 g/100g 49035-731_35b2b41d-2951-45d0-be90-b9d4f68baa90 49035-731 HUMAN OTC DRUG Miconazole 3 Combination Pack Miconazole Nitrate KIT 20070611 ANDA ANDA074926 Wal-Mart Stores, Inc. 49035-732_10fe2061-fb22-426d-a14a-9d6f0eb7e743 49035-732 HUMAN OTC DRUG Hydrocortisone anti-itch plus Hydrocortisone CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores, Inc. HYDROCORTISONE 10 mg/g 49035-733_971668c3-87bd-4f2c-a52f-5adee45ee46b 49035-733 HUMAN OTC DRUG Equate NiteTime DayTime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130815 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc 49035-734_efe10ec2-a8a7-4a91-848d-6050eddb2239 49035-734 HUMAN OTC DRUG Equate Nicotine Nicotine Polacrilex LOZENGE ORAL 20130214 ANDA ANDA203690 Wal-Mart Stores Inc NICOTINE 2 mg/1 49035-737_a91746d0-9f09-43e7-b226-e052fd82e847 49035-737 HUMAN OTC DRUG Equate Miconazole 1 Miconazole nitrate KIT 20130812 ANDA ANDA079114 Wal-Mart Stores Inc 49035-739_bda67032-54f3-e449-f7a7-c0f3b42c3e74 49035-739 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202194 Wal-Mart Stores Inc LANSOPRAZOLE 15 mg/1 49035-742_fcf98811-ce9a-484a-b06a-417fc2955d93 49035-742 HUMAN OTC DRUG Equate Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20110726 NDA NDA021920 Wal-Mart Stores Inc NAPROXEN SODIUM 220 mg/1 49035-751_23e58f77-c8ed-423f-8967-be736d1c4040 49035-751 HUMAN OTC DRUG Hygienic Cleansing Pad witch hazel SOLUTION RECTAL; TOPICAL 20070301 OTC MONOGRAPH FINAL part346 Wal-Mart Stores Inc WITCH HAZEL .5 mL/mL 49035-758_93ca15e9-36b8-4ca5-829c-837ced533fe4 49035-758 HUMAN OTC DRUG Wal-Mart Stores Inc. Equate Fluoride PASTE, DENTIFRICE DENTAL 20140701 OTC MONOGRAPH NOT FINAL part356 Wal-Mart Stores Inc. POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 49035-763_b8625f1b-2fa5-4a95-977f-11d1a4878771 49035-763 HUMAN OTC DRUG equate nitetime severe Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20140727 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 49035-784_fc388ed7-eedb-1227-e0d1-a4edcbb7302d 49035-784 HUMAN OTC DRUG Allergy Relief Fexofenadine hydrochloride TABLET ORAL 20110413 ANDA ANDA076502 Wal-Mart Stores, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 49035-793_e4a63659-ebd0-4ed2-84a7-88a8fb23b5c9 49035-793 HUMAN OTC DRUG Equate Hemorrhoidal Medicated Wipes Witch Hazel CLOTH TOPICAL 20100101 OTC MONOGRAPH FINAL part346 Wal-Mart Stores, Inc. WITCH HAZEL .5 mL/mL 49035-798_c1cad49e-8e72-46df-85b2-f71ac8a6ff65 49035-798 HUMAN OTC DRUG equate hair regrowth treatment for men Minoxidil SOLUTION TOPICAL 20110201 ANDA ANDA075598 Wal-Mart Stores Inc MINOXIDIL 3 g/60mL 49035-799_93a1ef96-a4de-4b50-af27-57a034431f23 49035-799 HUMAN OTC DRUG Equate Tussin DM Max Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20110628 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 49035-800_ea87c57b-0b3c-4821-8457-63a83738f10c 49035-800 HUMAN OTC DRUG Equate Ranitidine Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20130222 ANDA ANDA091429 Wal-Mart Stores Inc RANITIDINE HYDROCHLORIDE 150 mg/1 49035-801_0762c3b3-ddd9-41a9-98c0-a0d8dde11c39 49035-801 HUMAN OTC DRUG Island Spring Antibacterial Body Wash with Moisturizers Triclosan SOAP TOPICAL 20100819 OTC MONOGRAPH NOT FINAL part333E Wal-mart Stores Inc. TRICLOSAN .15 mL/100mL 49035-805_5895a5c0-2665-46fe-99f0-7422d9700254 49035-805 HUMAN OTC DRUG Island Spring Antibacterial Body Wash with Moisturizers Triclosan LIQUID TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC TRICLOSAN .15 mL/100mL 49035-809_ef65e2c2-c68c-4288-8996-72861a9d9de5 49035-809 HUMAN OTC DRUG Equate Antibiotic Plus Pain Relief Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20110421 OTC MONOGRAPH FINAL part333B Wal-Mart Stores Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 49035-812_d0444da2-9a7e-425e-a338-a368723a570a 49035-812 HUMAN OTC DRUG Clotrimazole Athletes Foot Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Wal-Mart Stores, Inc. CLOTRIMAZOLE 10 mg/g 49035-820_24cb1ce8-0489-4128-99f6-e2bafe04cbec 49035-820 HUMAN OTC DRUG Equate Cimetidine Cimetidine TABLET ORAL 20060927 ANDA ANDA075285 Wal-Mart Stores Inc CIMETIDINE 200 mg/1 49035-823_3eabcd9a-d2f5-4dd0-9d3b-9cb64c832218 49035-823 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Maximum Strength bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride OINTMENT TOPICAL 20100312 OTC MONOGRAPH FINAL part333B Wal-Mart Stores, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 49035-836_799d642a-9e45-45d6-9baa-9f9bdeaadc1c 49035-836 HUMAN OTC DRUG 2 in 1 Pyrithione zinc SHAMPOO TOPICAL 20120712 OTC MONOGRAPH FINAL part358H Wal-Mart Stores, Inc PYRITHIONE ZINC 10.3 mg/mL 49035-850_0630ed8b-453e-41af-95b6-85bf2633e7cf 49035-850 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20140404 OTC MONOGRAPH FINAL part358H Wal-Mart COAL TAR 1.02 mg/mL 49035-851_fc309c75-b95b-442f-8f54-aa7bab554ead 49035-851 HUMAN OTC DRUG Equate antacid regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20021113 OTC MONOGRAPH FINAL part332 Wal-Mart Stores Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 49035-852_d77e5d05-10b4-4088-b79b-7f82ca055ed3 49035-852 HUMAN OTC DRUG equate acid reducer Ranitidine TABLET, FILM COATED ORAL 20120212 ANDA ANDA091429 Wal-Mart Stores Inc RANITIDINE HYDROCHLORIDE 150 mg/1 49035-854_78b33c09-cca0-4ecf-aa8b-0e6d294790b9 49035-854 HUMAN OTC DRUG Equate Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20081014 ANDA ANDA078546 Wal-Mart Stores Inc NICOTINE 4 mg/1 49035-863_bd41fe6d-7ae6-4346-99b9-490944968d97 49035-863 HUMAN OTC DRUG Nighttime Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 Wal-Mart Stores Inc DOXYLAMINE SUCCINATE 25 mg/1 49035-866_04ec1406-b036-4ea4-beef-1f2214fe1035 49035-866 HUMAN OTC DRUG equate lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070708 OTC MONOGRAPH FINAL part358G Wal-Mart Stores Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL 49035-872_29ba6231-7141-4ad7-aa35-81eb4dfe0ee2 49035-872 HUMAN OTC DRUG Equate Vaporizing camphor, eucalyptus oil, menthol OINTMENT TOPICAL 20070112 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 48; 12; 26 mg/g; mg/g; mg/g 49035-873_fb3150c9-13b2-4d30-a360-1e77ac14416f 49035-873 HUMAN OTC DRUG equate nicotine Nicotine Polacrilex LOZENGE ORAL 20061215 ANDA ANDA077007 Wal-Mart Stores Inc NICOTINE 4 mg/1 49035-880_86fd4eac-46b9-4b73-8a34-0a0f3e3d38c4 49035-880 HUMAN OTC DRUG Equate antacid extra strength Aluminum hydroxide, Magnesium carbonate TABLET, CHEWABLE ORAL 19990907 OTC MONOGRAPH FINAL part331 Wal-Mart Stores Inc ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 49035-887_d126be1e-0a74-4381-ba86-4c74e254bc4c 49035-887 HUMAN OTC DRUG Equate Menthol extra strength Menthol PATCH TOPICAL 20030523 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc MENTHOL 50 mg/1 49035-888_ca3088a7-e1ec-4e69-80d9-fd0051bde938 49035-888 HUMAN OTC DRUG Equate Cool and Heat Extra Strength Menthol PATCH TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc MENTHOL 50 mg/1 49035-891_4b663bbc-52ea-4b8a-a520-9be1e77f9233 49035-891 HUMAN OTC DRUG Motion Sickness Relief Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 Wal-Mart Stores Inc DIMENHYDRINATE 50 mg/1 49035-892_a1a3583f-5d1a-4435-8ac0-3692481c8c55 49035-892 HUMAN OTC DRUG Natural Vegetable Laxative Sennosides TABLET ORAL 19950127 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc SENNOSIDES 8.6 mg/1 49035-897_3322ab68-589c-4c53-b6ef-899da9dd7902 49035-897 HUMAN OTC DRUG equate ibuprofen Ibuprofen SUSPENSION ORAL 19990202 ANDA ANDA074937 Wal-Mart Stores Inc IBUPROFEN 100 mg/5mL 49035-898_e35f113f-4119-4fde-98cd-5a42c766ce40 49035-898 HUMAN OTC DRUG Clean Apple Pyrithione zinc SHAMPOO TOPICAL 20131121 OTC MONOGRAPH FINAL part358H Wal-Mart Stores, Inc PYRITHIONE ZINC 1 g/mL 49035-901_5b974091-d484-448e-a693-af5dd05ad6df 49035-901 HUMAN OTC DRUG ALLERGY Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part336 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49035-904_34a75ef2-c836-457d-ad78-d123c007df66 49035-904 HUMAN OTC DRUG Hair Regrowth Treatment for Men Extra Strength Minoxidil SOLUTION TOPICAL 20020502 ANDA ANDA075518 Wal-Mart Stores, Inc. MINOXIDIL 50 mg/mL 49035-908_a50da3d7-74da-4d1b-afb9-260bf51f71ff 49035-908 HUMAN OTC DRUG equate nite time cold flu relief acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20051103 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 49035-912_6e32446c-fb5c-41ea-a4ca-6c423f662154 49035-912 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 Wal-Mart Stores Inc IBUPROFEN 200 mg/1 49035-913_159d2974-25e0-43fb-be3d-5f8531d24131 49035-913 HUMAN OTC DRUG equate night time cold and cough childrens Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20070719 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 49035-914_b4a8762c-8461-4292-83d2-1fff0fc911d0 49035-914 HUMAN OTC DRUG Aspirin Adult Low Dose Aspirin TABLET, COATED ORAL 20140725 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ASPIRIN 81 mg/1 49035-915_dcdcccf3-f3b3-4a45-8e44-4e9fd8011e24 49035-915 HUMAN OTC DRUG Equate omeprazole delayed release acid reducer Omeprazole TABLET, DELAYED RELEASE ORAL 20080227 NDA NDA022032 Wal-Mart Stores Inc OMEPRAZOLE 20 mg/1 49035-917_dbafbbf4-0799-4e05-9df7-64d0a1fc66be 49035-917 HUMAN OTC DRUG EQUATE Clinical Strength Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20110424 OTC MONOGRAPH FINAL part350 Wal-Mart Stores Inc ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g 49035-918_60643e5a-5023-48e9-9dda-a0a10b6eed44 49035-918 HUMAN OTC DRUG EQUATE CLINICAL STRENGTH DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20140817 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC SELENIUM SULFIDE 10 mg/mL 49035-923_2f0771a2-88b7-4675-bdcb-98b93a094989 49035-923 HUMAN OTC DRUG equate Eye Itch Relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20100708 ANDA ANDA077958 Wal-Mart Stores Inc KETOTIFEN FUMARATE .25 mg/mL 49035-928_78d548af-75e8-4ec4-afcc-161b53da9929 49035-928 HUMAN OTC DRUG equate daytime nitetime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride KIT 20080209 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc 49035-928_d28be689-47d1-499e-91f1-d93fb16fa985 49035-928 HUMAN OTC DRUG equate daytime nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl KIT 20110310 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc 49035-936_194debdd-3077-4713-abfd-5bb8edfcf8c0 49035-936 HUMAN OTC DRUG EQUATE LUBRICATING EYE DROPS CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN SOLUTION OPHTHALMIC 20120401 OTC MONOGRAPH FINAL part349 WAL-MART STORES INC CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL 49035-939_1762a831-66e8-4f8e-af4b-87c66f55c71a 49035-939 HUMAN OTC DRUG EQUATE LUBRICANT EYE DROPS POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL SOLUTION OPHTHALMIC 20120401 OTC MONOGRAPH FINAL part349 WAL-MART STORES INC POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mL/mL; mL/mL 49035-940_ddffad3c-5248-4c56-ae1d-19c8f1c5f1c2 49035-940 HUMAN OTC DRUG Chlor-Tabs Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc CHLORPHENIRAMINE MALEATE 4 mg/1 49035-944_8af74c41-0cac-4ca3-9723-9867702b5737 49035-944 HUMAN OTC DRUG equate hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20070925 OTC MONOGRAPH FINAL part346 Wal-Mart Stores Inc GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g 49035-946_aad92298-2e16-4055-a242-ee6c86c30bfa 49035-946 HUMAN OTC DRUG equate pain and fever infants Acetaminophen SUSPENSION ORAL 20110808 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/5mL 49035-949_a952086a-2d00-4d68-9466-4e2148525539 49035-949 HUMAN OTC DRUG Equate Milk of Magnesia Magnesium hydroxide LIQUID ORAL 20050421 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 49035-954_e49e1492-8990-46b2-8342-9d832f4713d9 49035-954 HUMAN OTC DRUG Antibacterial Citrus Fresh TRICLOSAN SOAP TOPICAL 20100819 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores, Inc TRICLOSAN .115 kg/100L 49035-957_cd8a86bc-8e28-4f46-8c52-45bf712a247a 49035-957 HUMAN OTC DRUG Equate Nicotine Nicotine Polacrilex LOZENGE ORAL 20130214 ANDA ANDA203690 Wal-Mart Stores Inc NICOTINE 4 mg/1 49035-958_714cb17a-734e-4d00-9d3a-0d89d296059a 49035-958 HUMAN OTC DRUG Equate Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130820 ANDA ANDA091135 Wal-Mart Stores Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 49035-959_0d25d84d-9416-460a-b89c-2c4ba3802d1e 49035-959 HUMAN OTC DRUG equate childrens pain and fever Acetaminophen SUSPENSION ORAL 20120124 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/5mL 49035-964_819611ce-20de-460c-80e1-afa61ee62246 49035-964 HUMAN OTC DRUG Equate Flu and Severe Cold and Cough Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20110711 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 49035-965_1358bdc1-5ac9-440d-9eb2-de47484f79ad 49035-965 HUMAN OTC DRUG Soothing Moisturizing Colloidal oatmeal CREAM TOPICAL 20140422 OTC MONOGRAPH FINAL part347 Wal-Mart Stores, Inc OATMEAL 10.4 mg/g 49035-966_13f2c073-8356-4640-99d7-a4a1a1cfc956 49035-966 HUMAN OTC DRUG Anticavity Sodium Fluoride MOUTHWASH ORAL 20100819 OTC MONOGRAPH FINAL part355 Wal-Mart Stores, Inc. SODIUM FLUORIDE .02 kg/100L 49035-975_fbd4f5a3-f49d-4817-961d-e41d94416a8f 49035-975 HUMAN OTC DRUG Equate Acetaminophen Acetaminophen TABLET ORAL 20130809 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 500 mg/1 49035-977_23682334-4d3e-4e33-b89d-c3b2725e038f 49035-977 HUMAN OTC DRUG equate nitetime cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20060717 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 49035-985_f0ecca61-e1cf-4b2e-bf72-9d91ae2a4652 49035-985 HUMAN OTC DRUG Bodycology Sweet Petals Ethyl Alcohol GEL TOPICAL 20110409 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores, Inc. ALCOHOL 70 mL/100mL 49035-987_c7e441a0-026e-4646-9b88-a1b9c34f07a5 49035-987 HUMAN OTC DRUG UNDECYLENIC ACID UNDECYLENIC ACID LIQUID TOPICAL 20080601 OTC MONOGRAPH FINAL part333C Wal-Mart Stores Inc UNDECYLENIC ACID 288 mg/mL 49035-990_f62dacae-3589-4113-a4ef-2cc079887731 49035-990 HUMAN OTC DRUG Undecylenic Acid Antifungal Liquid LIQUID TOPICAL 20140508 OTC MONOGRAPH FINAL part333C Wal-Mart Stores, Inc. UNDECYLENIC ACID .25 g/mL 49035-992_155414b8-b645-4e4c-99a8-d4998ae50c66 49035-992 HUMAN OTC DRUG Bodycology Vanilla Cupcake Ethyl Alcohol GEL TOPICAL 20110409 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores, Inc. ALCOHOL 70 mL/100mL 49035-994_95c8a02a-ffee-4af2-b03d-51b159fa135e 49035-994 HUMAN OTC DRUG equate daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20060814 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 49035-998_a3da94ee-c495-4fc0-836e-a03f7411e0f2 49035-998 HUMAN OTC DRUG Equate Nicotine Nicotine Polacrilex LOZENGE ORAL 20061215 ANDA ANDA077007 Wal-Mart Stores Inc NICOTINE 2 mg/1 49035-999_aaefd981-5d97-4c56-84de-e35f20dae537 49035-999 HUMAN OTC DRUG Equate Anti Wrinkle SPF 15 Ensulizole, Octinoxate CREAM TOPICAL 20090507 OTC MONOGRAPH NOT FINAL part352 Wal-Mart Stores Inc ENSULIZOLE; OCTINOXATE 1; 6 g/100g; g/100g 49121-001_b2e46589-9ed5-4694-a5bc-d683939a640a 49121-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20120401 UNAPPROVED MEDICAL GAS Global Medical LLC OXYGEN 99 L/100L 49158-500_d7bced93-fcb9-4db5-aad5-eb90d34aee25 49158-500 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20010123 ANDA ANDA075657 Taro Pharmaceuticals U.S.A., Inc. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 49158-501_d7bced93-fcb9-4db5-aad5-eb90d34aee25 49158-501 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20010123 ANDA ANDA075657 Taro Pharmaceuticals U.S.A., Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 49158-502_d7bced93-fcb9-4db5-aad5-eb90d34aee25 49158-502 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20010123 ANDA ANDA075657 Taro Pharmaceuticals U.S.A., Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 49158-503_d7bced93-fcb9-4db5-aad5-eb90d34aee25 49158-503 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20010123 ANDA ANDA075657 Taro Pharmaceuticals U.S.A., Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 49158-505_f578ff8b-704c-4df5-945f-f710a43513e7 49158-505 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980430 ANDA ANDA075078 Taro Pharmaceuticals Laboratories, Inc. ETODOLAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49158-506_f578ff8b-704c-4df5-945f-f710a43513e7 49158-506 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980430 ANDA ANDA075078 Taro Pharmaceuticals Laboratories, Inc. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49158-507_f578ff8b-704c-4df5-945f-f710a43513e7 49158-507 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET ORAL 19980311 ANDA ANDA075074 Taro Pharmaceuticals Laboratories, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49158-508_f578ff8b-704c-4df5-945f-f710a43513e7 49158-508 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET ORAL 20000425 ANDA ANDA075074 Taro Pharmaceuticals Laboratories, Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49199-100_6cb26c17-ed7a-4751-af1e-2cc884369890 49199-100 HUMAN OTC DRUG Menticol first aid antiseptic and external analgesic lotion MENTHOL , ALCOHOL LOTION TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Perfumeria Lemaitre S.A. ALCOHOL; MENTHOL .39; 70 mL/100mL; mL/100mL 49203-710_057276ba-97a1-4870-ad23-414c873c0fbf 49203-710 HUMAN OTC DRUG Skin Active Intensive Day Octocrylene, Avobenzone, Oxybenzone, and Ensulizole CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part352 Cat Media Pty Ltd AVOBENZONE; ENSULIZOLE; OCTOCRYLENE; OXYBENZONE 19.9; 9.9; 49.7; 9.9 mg/mL; mg/mL; mg/mL; mg/mL 49203-730_da4d9b79-878c-4d0b-a03d-5c00ff82eb39 49203-730 HUMAN OTC DRUG Skin Doctors Photo Age Reverse Night Serum Thermus Thermophilus Lysate and Glycerin LIQUID TOPICAL 20100401 UNAPPROVED DRUG OTHER Cat Media Pty Ltd GLYCERIN; THERMUS THERMOPHILUS LYSATE 2.54; 48.2 mg/mL; mg/mL 49203-740_856ccb85-0961-4970-ad90-7a569600521d 49203-740 HUMAN OTC DRUG Skin Doctors Photo Age Reverse Thermus Thermophilus Lysate and Glycerin CREAM TOPICAL 20100401 UNAPPROVED DRUG OTHER Cat Media Pty Ltd GLYCERIN; THERMUS THERMOPHILUS LYSATE 2.4; 46.1 mg/mL; mg/mL 49204-001_b2e87d62-e14a-4839-b5e3-8c79b4a97813 49204-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19770701 UNAPPROVED MEDICAL GAS HARTMAN BROTHERS, INC. OXYGEN 990 mL/L 49204-002_91c5ac0a-40ea-4f74-8424-3599b13fa14f 49204-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS NOT APPLICABLE 20100409 UNAPPROVED MEDICAL GAS HARTMAN BROTHERS, INC NITROGEN 990 mL/L 49204-003_c9d7c6bd-5368-4450-88af-00cfbd22e944 49204-003 HUMAN PRESCRIPTION DRUG AIR AIR GAS NOT APPLICABLE 20100409 UNAPPROVED MEDICAL GAS HARTMAN BROTHERS, INC AIR 1000 mL/L 49215-0001_eeb9c4e0-dbbb-4bc8-a06b-07a46600548d 49215-0001 HUMAN OTC DRUG GH Flex Arnica Montana, Carduus Marianus, Hepar Suis, Korean Ginseng, Phosphoricum Acidum, Pituitaria Glandula, LIQUID ORAL 20131024 UNAPPROVED HOMEOPATHIC Safe Anabolic Sciences ARNICA MONTANA; ASIAN GINSENG; PHOSPHORIC ACID; PORK LIVER; SILYBUM MARIANUM SEED; SUS SCROFA PITUITARY GLAND 3; 1; 3; 6; 1; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49215-0003_2a342ea5-3000-4886-9622-ab3ec67b15e1 49215-0003 HUMAN OTC DRUG Winnie Flex Amino Acids, Apis Mellifica, Arnica Montana, Fucus Vesiculosus, Gambogia, Hepar Suis, Phosphoricum Acidum, Pituitaria Glandula suis, Thuja Occidentalis, Thyroidinum, LIQUID ORAL 20131024 UNAPPROVED HOMEOPATHIC Safe Anabolic Sciences AMINO ACIDS; APIS MELLIFERA; ARNICA MONTANA; FUCUS VESICULOSUS; GAMBOGE; PHOSPHORIC ACID; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; THUJA OCCIDENTALIS LEAF 6; 3; 3; 3; 3; 3; 6; 24; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 49215-0004_790045b3-207a-4c26-a79c-82e55abb9a9d 49215-0004 HUMAN OTC DRUG Test Flex Avena Sativa, Calcarea Carbonica, Damiana, Glandula Suprarenalis Suis, Magnesia Carbonica, Millefolium, Pituitaria Glandula, Sabal Serrulata, Thuja Occidentalis, Urtica Urens, SPRAY ORAL 20140110 UNAPPROVED HOMEOPATHIC Safe Anabolic Sciences ACHILLEA MILLEFOLIUM; AVENA SATIVA FLOWERING TOP; BOS TAURUS PITUITARY GLAND; MAGNESIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SAW PALMETTO; SUS SCROFA ADRENAL GLAND; THUJA OCCIDENTALIS LEAF; TURNERA DIFFUSA LEAFY TWIG; URTICA URENS 6; 3; 12; 8; 8; 3; 6; 6; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49215-0005_998edf28-07d5-4034-9e65-07b845d3ce7c 49215-0005 HUMAN OTC DRUG Winnie Flex Apis Mellifica, Arnica Montana, Calcarea Carbonica, Fucus Vesiculosus, Gambogia, Hepar Suis, Phosphoricum Acidum, Pituitaria Glandula, Thuja Occidentalis, Thyroidinum Suis, SPRAY ORAL 20140110 UNAPPROVED HOMEOPATHIC Safe Anabolic Sciences APIS MELLIFERA; ARNICA MONTANA; FUCUS VESICULOSUS; GAMBOGE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; THUJA OCCIDENTALIS LEAF 3; 3; 3; 3; 8; 3; 6; 24; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 49221-0025_1626830c-7388-4d25-9b46-af58434cd5cf 49221-0025 HUMAN PRESCRIPTION DRUG MEDICAL AIR AIR GAS RESPIRATORY (INHALATION) 19490101 UNAPPROVED MEDICAL GAS Strate Welding Supply Co., Inc. OXYGEN 21 L/100L 49221-0030_df49200c-3239-40ae-a6cd-2ed7f54dde8f 49221-0030 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19490101 UNAPPROVED MEDICAL GAS Strate Welding Supply Co., Inc. OXYGEN 99 L/100L 49221-0041_2cc6c838-af03-4e90-895a-c5e46901e122 49221-0041 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19490101 UNAPPROVED MEDICAL GAS Strate Welding Supply Co., Inc. NITROUS OXIDE 99 L/100L 49221-0042_dcb979de-d8c5-46ef-a503-80f4c98ef60a 49221-0042 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19490101 UNAPPROVED MEDICAL GAS Strate Welding Supply Co., Inc. NITROGEN 99 L/100L 49221-3000_d7fe466d-d57c-475d-8a04-e73173382479 49221-3000 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19490101 UNAPPROVED MEDICAL GAS Strate Welding Supply Co., Inc. OXYGEN 99 L/100L 49226-206_e32b3dad-78a6-4c1a-9037-29d6e0338da0 49226-206 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20080910 ANDA ANDA078325 Be Better Networks NICOTINE 2 mg/1 49226-344_a03a3b78-ee4e-4c62-b206-6b919159f2f8 49226-344 HUMAN OTC DRUG nicotine polacrilex Nicotine Polacrilex LOZENGE ORAL 20080910 ANDA ANDA077007 Be Better Networks NICOTINE 2 mg/1 49226-873_f061b9c3-fcdb-450d-9919-e5bcaefcf801 49226-873 HUMAN OTC DRUG nicotine polacrilex Nicotine Polacrilex LOZENGE ORAL 20080910 ANDA ANDA077007 Be Better Networks NICOTINE 4 mg/1 49230-188_369a88c0-add6-11e2-9e96-0800200c9a66 49230-188 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 1.5; 15.2; 567; 353 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-188_7c015e00-720a-11e2-bcfd-0800200c9a66 49230-188 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 1.5; 15.2; 567; 392 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-188_f851a3d0-add7-11e2-9e96-0800200c9a66 49230-188 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 1.5; 15.2; 567; 353 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-188_fb106140-7224-11e2-bcfd-0800200c9a66 49230-188 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 1.5; 15.2; 567; 392 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-191_369a88c0-add6-11e2-9e96-0800200c9a66 49230-191 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 2.5; 15.2; 567; 353 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-191_7c015e00-720a-11e2-bcfd-0800200c9a66 49230-191 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 2.5; 15.2; 567; 392 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-191_f851a3d0-add7-11e2-9e96-0800200c9a66 49230-191 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 2.5; 15.2; 567; 353 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-191_fb106140-7224-11e2-bcfd-0800200c9a66 49230-191 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 2.5; 15.2; 567; 392 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-194_369a88c0-add6-11e2-9e96-0800200c9a66 49230-194 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 4.25; 15.2; 567; 353 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-194_7c015e00-720a-11e2-bcfd-0800200c9a66 49230-194 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 4.25; 15.2; 567; 392 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-194_f851a3d0-add7-11e2-9e96-0800200c9a66 49230-194 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 4.25; 15.2; 567; 353 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-194_fb106140-7224-11e2-bcfd-0800200c9a66 49230-194 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 4.25; 15.2; 567; 392 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-197_369a88c0-add6-11e2-9e96-0800200c9a66 49230-197 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 1.5; 5.08; 538; 409 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-197_7c015e00-720a-11e2-bcfd-0800200c9a66 49230-197 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 1.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-197_f851a3d0-add7-11e2-9e96-0800200c9a66 49230-197 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 1.5; 5.08; 538; 409 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-197_fb106140-7224-11e2-bcfd-0800200c9a66 49230-197 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 1.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-200_369a88c0-add6-11e2-9e96-0800200c9a66 49230-200 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 2.5; 5.08; 538; 409 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-200_7c015e00-720a-11e2-bcfd-0800200c9a66 49230-200 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 2.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-200_f851a3d0-add7-11e2-9e96-0800200c9a66 49230-200 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 2.5; 5.08; 538; 409 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-200_fb106140-7224-11e2-bcfd-0800200c9a66 49230-200 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 2.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-203_369a88c0-add6-11e2-9e96-0800200c9a66 49230-203 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 4.25; 5.08; 538; 409 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-203_7c015e00-720a-11e2-bcfd-0800200c9a66 49230-203 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 4.25; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-203_f851a3d0-add7-11e2-9e96-0800200c9a66 49230-203 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 4.25; 5.08; 538; 409 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-203_fb106140-7224-11e2-bcfd-0800200c9a66 49230-203 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 25.7; 4.25; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-206_3eb77d4c-8c81-4e7c-b831-fbbc35c251a0 49230-206 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4; 1.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-206_46c3197e-3d95-4349-974d-a32d9f753250 49230-206 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4; 1.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-206_494d8150-addd-11e2-9e96-0800200c9a66 49230-206 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4; 1.5; 5.08; 538; 409 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-206_bc39e4d0-addb-11e2-9e96-0800200c9a66 49230-206 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4; 1.5; 5.08; 538; 409 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-209_3eb77d4c-8c81-4e7c-b831-fbbc35c251a0 49230-209 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4; 2.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-209_46c3197e-3d95-4349-974d-a32d9f753250 49230-209 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4; 2.5; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-209_494d8150-addd-11e2-9e96-0800200c9a66 49230-209 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4; 2.5; 5.08; 538; 409 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-209_bc39e4d0-addb-11e2-9e96-0800200c9a66 49230-209 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4; 2.5; 5.08; 538; 409 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-212_3eb77d4c-8c81-4e7c-b831-fbbc35c251a0 49230-212 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4; 4.25; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-212_46c3197e-3d95-4349-974d-a32d9f753250 49230-212 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4; 4.25; 5.08; 538; 448 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-212_494d8150-addd-11e2-9e96-0800200c9a66 49230-212 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4; 4.25; 5.08; 538; 409 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-212_bc39e4d0-addb-11e2-9e96-0800200c9a66 49230-212 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 18.4; 4.25; 5.08; 538; 409 mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 49230-300_7dba21af-e29d-11e3-8b68-0800200c9a66 49230-300 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAVENOUS 20070412 ANDA ANDA078177 Fresenius Medical Care North America SODIUM CHLORIDE 900 mg/100mL 49230-530_d3e872e0-b2d7-473b-be86-c593b4fda3f2 49230-530 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20110127 NDA NDA021135 Fresenius Medical Care North America IRON SUCROSE 20 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 49230-534_d3e872e0-b2d7-473b-be86-c593b4fda3f2 49230-534 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20081104 NDA NDA021135 Fresenius Medical Care North America IRON SUCROSE 20 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 49230-640_8c973fd0-17a6-11e4-8c21-0800200c9a66 49230-640 HUMAN PRESCRIPTION DRUG PhosLo Calcium Acetate CAPSULE ORAL 20010402 NDA NDA021160 Fresenius Medical Care North America CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 49230-643_71ea7a00-198e-11e4-8c21-0800200c9a66 49230-643 HUMAN PRESCRIPTION DRUG PHOSLYRA calcium acetate oral solution SOLUTION ORAL 20110415 NDA NDA022581 Fresenius Medical Care North America CALCIUM ACETATE 667 mg/5mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 49230-645_aadd4003-3752-11e4-8510-0800200c9a66 49230-645 HUMAN PRESCRIPTION DRUG Velphoro sucroferric oxyhydroxide TABLET, CHEWABLE ORAL 20131127 NDA NDA205109 Fresenius Medical Care North America FERRIC OXYHYDROXIDE 500 mg/1 49252-001_7ac4b965-1cfa-4d0d-bcac-51ad644ce616 49252-001 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20120601 ANDA ANDA201991 Inventia Healthcare Private Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49260-611_beb66257-641f-415c-baa9-cf01657cbab3 49260-611 HUMAN OTC DRUG Help I have allergies Loratadine TABLET ORAL 20090701 UNAPPROVED DRUG OTHER Help Remedies, Inc. LORATADINE 10 mg/1 49260-613_0e723c3c-c6bd-46b2-9302-1faec8278095 49260-613 HUMAN OTC DRUG Help I cant Sleep Diphenhydramine TABLET ORAL 20090701 OTC MONOGRAPH FINAL part336 Help Remedies, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49260-615_62df5f70-2fbf-4620-ab95-09680d33f306 49260-615 HUMAN OTC DRUG Help I Have an Aching Body Ibuprofen TABLET ORAL 20090701 ANDA ANDA075139 Help Remedies, Inc. IBUPROFEN 200 mg/1 49260-710_1073bca3-c40b-4dcc-b8e1-80c90a2dbce1 49260-710 HUMAN OTC DRUG Help I Have a Headache Acetaminophen TABLET ORAL 20120501 OTC MONOGRAPH NOT FINAL part343 Help Remedies, Inc. ACETAMINOPHEN 325 mg/1 49260-716_c8c22f51-49cf-468f-b5da-177cc774cde5 49260-716 HUMAN OTC DRUG Help I Have a Stuffy Nose Phenylephrine TABLET ORAL 20120501 OTC MONOGRAPH FINAL part341 Help Remedies, Inc. PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 49281-014_8da0152c-f97a-401d-a304-1d7a29bacc97 49281-014 VACCINE FLUZONE INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20140627 20150630 BLA BLA103914 Sanofi Pasteur Inc. INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL 49281-183_d78e1180-5714-11e1-b7ee-0002a5d5c51b 49281-183 HUMAN PRESCRIPTION DRUG Sklice ivermectin LOTION TOPICAL 20120709 NDA NDA202736 Sanofi Pasteur, Inc IVERMECTIN .585 g/117g Antiparasitic [EPC],Pediculicide [EPC] 49281-190_0554e76f-a5a3-4480-998c-62bd4e40c0b8 49281-190 PLASMA DERIVATIVE IMOGAM RABIES-HT HUMAN RABIES VIRUS IMMUNE GLOBULIN INJECTION, SOLUTION INTRAMUSCULAR 19840427 BLA BLA103932 Sanofi Pasteur Inc. HUMAN RABIES VIRUS IMMUNE GLOBULIN 150 [iU]/mL 49281-215_64c8684f-df76-431d-8273-f5e5e74f390f 49281-215 VACCINE TENIVAC CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20101208 BLA BLA103171 Sanofi Pasteur Inc. CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5; 2 [Lf]/.5mL; [Lf]/.5mL Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient] 49281-225_71231ab7-9fcd-4f58-a860-54a74a480569 49281-225 VACCINE DIPHTHERIA AND TETANUS TOXOIDS ADSORBED CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20100329 BLA BLA103944 Sanofi Pasteur Inc. CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5; 25 [Lf]/.5mL; [Lf]/.5mL Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient] 49281-250_4ac3daa6-590a-42d6-9143-78923c6b05f7 49281-250 VACCINE IMOVAX RABIES RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) and WATER KIT 20130930 BLA BLA103931 Sanofi Pasteur Inc. 49281-286_4f42cb3a-2ce6-401d-b796-77d4bc8713fc 49281-286 VACCINE DAPTACEL corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen INJECTION, SUSPENSION INTRAMUSCULAR 20020514 BLA BLA103666 Sanofi Pasteur Inc. BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5; 5; 3; 10; 5; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient] 49281-291_704e0b02-2648-470f-9598-91257dd31444 49281-291 VACCINE DECAVAC CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) SUSPENSION INTRAMUSCULAR 20040324 BLA BLA103921 Sanofi Pasteur Inc. CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5; 2 [Lf]/.5mL; [Lf]/.5mL Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient] 49281-394_8da0152c-f97a-401d-a304-1d7a29bacc97 49281-394 VACCINE FLUZONE INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20140627 20150630 BLA BLA103914 Sanofi Pasteur Inc. INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL 49281-395_8813b54d-cd25-4449-b398-527a79356206 49281-395 VACCINE FLUZONE High-Dose INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20140627 20150630 BLA BLA103914 Sanofi Pasteur Inc. INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED) 60; 60; 60 ug/.5mL; ug/.5mL; ug/.5mL 49281-400_2fcd111f-348b-4df4-9e5e-fa2e83300a6e 49281-400 VACCINE Adacel TDaP CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS PERTACTIN ANTIGEN, and BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN INJECTION, SUSPENSION INTRAMUSCULAR 20050610 BLA BLA125111 Sanofi Pasteur Inc. BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5; 5; 3; 2.5; 5; 2 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient] 49281-414_06b95115-f765-4c4d-be96-10e3194e14cc 49281-414 VACCINE FLUZONE QUADRIVALENT INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20140627 20150630 BLA BLA103914 Sanofi Pasteur Inc. INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED) 15; 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL 49281-489_38ba0c9b-b8f6-4c6b-8987-3faa7e12a58a 49281-489 VACCINE MENOMUNE - A/C/Y/W-135 COMBINED Neisseria Meningitidis Group A Capsular Polysaccharide Antigen, Neisseria Meningitidis Group C Capsular Polysaccharide Antigen, Neisseria Meningitidis Group Y Capsular Polysaccharide Antigen, and Neisseria Meningitidis Group W-135 Capsular Polysaccharide Antigen KIT 19811123 BLA BLA103926 Sanofi Pasteur Inc. 49281-489_5f68f87c-2950-4f9d-ba48-b81790c2ff54 49281-489 VACCINE MENOMUNE - A/C/Y/W-135 COMBINED NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE ANTIGEN, NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE ANTIGEN, NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE ANTIGEN and NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE ANTIGEN KIT 19811123 BLA BLA103924 Sanofi Pasteur Inc. 49281-510_f408b684-659f-4b8d-81e0-ba12b7f1113d 49281-510 VACCINE PENTACEL DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE KIT 20080620 BLA BLA125145 Sanofi Pasteur Inc. 49281-514_06b95115-f765-4c4d-be96-10e3194e14cc 49281-514 VACCINE FLUZONE QUADRIVALENT INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20140627 20150630 BLA BLA103914 Sanofi Pasteur Inc. INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED) 7.5; 7.5; 7.5; 7.5 ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL 49281-545_81ad038e-85fc-4847-a499-e5da6235f226 49281-545 VACCINE ActHIB HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN KIT 19930330 BLA BLA103935 Sanofi Pasteur Inc. 49281-589_ca8649a4-f1b0-4676-9c22-74670afd4027 49281-589 VACCINE Menactra NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, and NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN INJECTION, SOLUTION INTRAMUSCULAR 20050114 BLA BLA125089 Sanofi Pasteur Inc. NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN 4; 4; 4; 4 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 49281-621_06b95115-f765-4c4d-be96-10e3194e14cc 49281-621 VACCINE FLUZONE QUADRIVALENT INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20140627 20150630 BLA BLA103914 Sanofi Pasteur Inc. INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED) 15; 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL 49281-640_3b63f190-7d2d-4fd7-ab3e-b07378f44d93 49281-640 VACCINE INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20090915 BLA BLA103914 Sanofi Pasteur Inc. INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL 49281-650_3b63f190-7d2d-4fd7-ab3e-b07378f44d93 49281-650 VACCINE INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20090915 BLA BLA103914 Sanofi Pasteur Inc. INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL 49281-709_654bbb59-920d-47db-8490-db3243285b7e 49281-709 VACCINE FLUZONE Intradermal INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRADERMAL 20140627 20150630 BLA BLA103914 Sanofi Pasteur Inc. INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED) 9; 9; 9 ug/.1mL; ug/.1mL; ug/.1mL 49281-752_cc5cd6c3-88e7-4ee5-b1ac-8abf5b5a3599 49281-752 HUMAN PRESCRIPTION DRUG TUBERSOL Tuberculin Purified Protein Derivative INJECTION, SOLUTION INTRADERMAL 19560815 BLA BLA103941 Sanofi Pasteur Inc. TUBERCULIN PURIFIED PROTEIN DERIVATIVE 5 [iU]/.1mL Skin Test Antigen [EPC],Tuberculosis Skin Test [EPC],Cell-mediated Immunity [PE],Antigens, Bacterial [Chemical/Ingredient] 49281-790_47d28f8b-8293-4e16-a084-cc7936faa9b7 49281-790 VACCINE Typhim Vi SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN INJECTION, SOLUTION INTRAMUSCULAR 19941128 BLA BLA103936 Sanofi Pasteur Inc. SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN 25 ug/.5mL Inactivated Salmonella Typhi Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Vaccines, Typhoid [Chemical/Ingredient],Vi polysaccharide vaccine, typhoid [Chemical/Ingredient] 49281-800_49bb9a4c-f387-4f3d-8c2f-12977314b8ec 49281-800 VACCINE TETANUS TOXOID ADSORBED CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20050923 BLA BLA103913 Sanofi Pasteur Inc. CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [Lf]/.5mL Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient] 49281-820_49bb9a4c-f387-4f3d-8c2f-12977314b8ec 49281-820 VACCINE TETANUS TOXOID ADSORBED CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20050923 BLA BLA103913 Sanofi Pasteur Inc. CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [Lf]/.5mL Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient] 49281-860_e747a77e-d85c-42cc-b66a-1ced18592ee0 49281-860 VACCINE IPOL POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED), POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED), and POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 19901221 BLA BLA103930 Sanofi Pasteur Inc. POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 40; 8; 32 [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 49281-880_6fd44443-0288-4e69-a3ef-6af6a1d10104 49281-880 VACCINE THERACYS BACILLUS CALMETTE-GUERIN SUBSTRAIN CONNAUGHT LIVE ANTIGEN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVESICAL 20110722 BLA BLA103943 Sanofi Pasteur Inc. BACILLUS CALMETTE-GUERIN SUBSTRAIN CONNAUGHT LIVE ANTIGEN 81 mg/3mL 49281-912_b95143a8-5f07-4b6d-a50f-437cc76e1f5c 49281-912 VACCINE Sodium Chloride Sodium Chloride INJECTION SUBCUTANEOUS 19530522 BLA BLA103915 Sanofi Pasteur Inc. 49281-915_b95143a8-5f07-4b6d-a50f-437cc76e1f5c 49281-915 VACCINE YF-VAX YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION SUBCUTANEOUS 19530522 BLA BLA103915 Sanofi Pasteur Inc. YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN 4.74 [PFU]/.5mL Live Attenuated Yellow Fever Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Yellow Fever Vaccine [Chemical/Ingredient] 49283-005_a4dbac5a-4791-44a5-b531-01693316a8cb 49283-005 HUMAN OTC DRUG FAST RELIEF ARTROSAMIN Menthol, Methyl Salicylate CREAM TOPICAL 20131111 OTC MONOGRAPH NOT FINAL part348 Chemco Corporation MENTHOL; METHYL SALICYLATE 2.5; 12.5 g/100g; g/100g 49283-006_e54e85df-63d5-4a0c-b3bd-19d17c0605d5 49283-006 HUMAN OTC DRUG FAST RELIEF REUMACETIN Menthol, Methyl Salicylate CREAM TOPICAL 20130826 OTC MONOGRAPH NOT FINAL part348 Chemco Corporation MENTHOL; METHYL SALICYLATE 2.5; 12.5 g/100g; g/100g 49283-011_49803f6d-f90e-427c-994a-982d9f344c14 49283-011 HUMAN OTC DRUG Natural 17 Anti-Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20130808 OTC MONOGRAPH FINAL part358H Chemco Corporation PYRITHIONE ZINC 1 g/100mL 49283-511_25b9717a-0ab5-4725-afdb-51e5e64a5d1b 49283-511 HUMAN OTC DRUG FAST RELIEF ARTROSAMIN Menthol, Methyl Salicylate CREAM TOPICAL 20130820 OTC MONOGRAPH NOT FINAL part348 Chemco Corporation MENTHOL; METHYL SALICYLATE 2.5; 7.5 g/100g; g/100g 49283-512_d46bbf3d-f22e-4515-a883-a7bca00908bc 49283-512 HUMAN OTC DRUG FAST RELIEF REUMACETIN Menthol, Methyl Salicylate CREAM TOPICAL 20130826 OTC MONOGRAPH NOT FINAL part348 Chemco Corporation MENTHOL; METHYL SALICYLATE 2.5; 7.5 g/100g; g/100g 49288-0001_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0001 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0002_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0002 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0003_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0003 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA .025 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0004_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0004 HUMAN PRESCRIPTION DRUG A Mold Mixture A Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BOTRYTIS CINEREA; CANDIDA TROPICALIS; CHAETOMIUM GLOBOSUM; COCHLIOBOLUS SATIVUS; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; MUCOR PLUMBEUS; MUCOR RACEMOSUS; NEUROSPORA INTERMEDIA; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; RHIZOPUS STOLONIFER; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE .0017; .0017; .0017; .0017; .0067; .0067; .0033; .0067; .0067; .0067; .0067; .0067; .0022; .0022; .0033; .0011; .0011; .0011; .0011; .0011; .0011; .0067; .0022; .0067; .0067; .0067 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC] 49288-0005_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0005 HUMAN PRESCRIPTION DRUG A Mold Mixture A Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BOTRYTIS CINEREA; CANDIDA TROPICALIS; CHAETOMIUM GLOBOSUM; COCHLIOBOLUS SATIVUS; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; MUCOR PLUMBEUS; MUCOR RACEMOSUS; NEUROSPORA INTERMEDIA; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; RHIZOPUS STOLONIFER; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE .0008; .0008; .0008; .0008; .0033; .0033; .0017; .0033; .0033; .0033; .0033; .0033; .0011; .0011; .0017; .0006; .0006; .0006; .0006; .0006; .0006; .0033; .0011; .0033; .0033; .0033 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC] 49288-0006_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0006 HUMAN PRESCRIPTION DRUG A Mold Mixture A Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BOTRYTIS CINEREA; CANDIDA TROPICALIS; CHAETOMIUM GLOBOSUM; COCHLIOBOLUS SATIVUS; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; MUCOR PLUMBEUS; MUCOR RACEMOSUS; NEUROSPORA INTERMEDIA; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; RHIZOPUS STOLONIFER; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE .0004; .0004; .0004; .0004; .0017; .0017; .0008; .0017; .0017; .0017; .0017; .0017; .0006; .0006; .0008; .0003; .0003; .0003; .0003; .0003; .0003; .0017; .0006; .0017; .0017; .0017 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC] 49288-0007_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0007 HUMAN PRESCRIPTION DRUG Aspergillus Mixture Aspergillus Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS .0025; .0025; .0025; .0025 g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0008_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0008 HUMAN PRESCRIPTION DRUG Aspergillus Mixture Aspergillus Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0009_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0009 HUMAN PRESCRIPTION DRUG Almond Almond INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ALMOND .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 49288-0010_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0010 HUMAN PRESCRIPTION DRUG Apple Apple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. APPLE .05 g/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] 49288-0011_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0011 HUMAN PRESCRIPTION DRUG Apricot Apricot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. APRICOT 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0012_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0012 HUMAN PRESCRIPTION DRUG Asparagus Asparagus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ASPARAGUS .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0013_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0013 HUMAN PRESCRIPTION DRUG Avocado Avocado INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AVOCADO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0014_13c9eea1-38b5-472b-b735-a814ca886718 49288-0014 HUMAN PRESCRIPTION DRUG Acacia Pollen Acacia Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740423 BLA BLA102223 Antigen Laboratories, Inc. ACACIA BAILEYANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0015_13c9eea1-38b5-472b-b735-a814ca886718 49288-0015 HUMAN PRESCRIPTION DRUG Smooth (Tag) Alder Smooth (Tag) Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740423 BLA BLA102223 Antigen Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0016_13c9eea1-38b5-472b-b735-a814ca886718 49288-0016 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0017_13c9eea1-38b5-472b-b735-a814ca886718 49288-0017 HUMAN PRESCRIPTION DRUG Ash Mixture Ash Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0018_13c9eea1-38b5-472b-b735-a814ca886718 49288-0018 HUMAN PRESCRIPTION DRUG Ash Mixture Ash Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN .01; .01 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0019_13c9eea1-38b5-472b-b735-a814ca886718 49288-0019 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS VELUTINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0020_13c9eea1-38b5-472b-b735-a814ca886718 49288-0020 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740423 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0021_13c9eea1-38b5-472b-b735-a814ca886718 49288-0021 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0022_13c9eea1-38b5-472b-b735-a814ca886718 49288-0022 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0023_13c9eea1-38b5-472b-b735-a814ca886718 49288-0023 HUMAN PRESCRIPTION DRUG Aspen Pollen Aspen Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POPULUS TREMULOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0024_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0024 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0025_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0025 HUMAN PRESCRIPTION DRUG Careless Weed Careless Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0026_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0026 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ATRIPLEX CANESCENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0027_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0027 HUMAN PRESCRIPTION DRUG Shadscale Shadscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ATRIPLEX CONFERTIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0028_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0028 HUMAN PRESCRIPTION DRUG Lenscale Lenscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0029_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0029 HUMAN PRESCRIPTION DRUG Alfalfa Pollen Alfalfa Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MEDICAGO SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0030_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0030 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FUMIGATUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0031_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0031 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FUMIGATUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0032_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0032 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0033_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0033 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740423 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0034_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0034 HUMAN PRESCRIPTION DRUG Atriplex Mixture Atriplex Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ATRIPLEX CANESCENS POLLEN; ATRIPLEX LENTIFORMIS POLLEN; ATRIPLEX POLYCARPA POLLEN; ATRIPLEX WRIGHTII POLLEN .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0035_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0035 HUMAN PRESCRIPTION DRUG B Mold Mixture B Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SPICIFER; COLLETOTRICHUM COCCODES; HYPOMYCES PERNICIOSUS; KHUSKIA ORYZAE; MICROASCUS BREVICAULIS; MYROTHECIUM VERRUCARIA; NEUROSPORA CRASSA; PAECILOMYCES VARIOTII; PASSALORA FULVA; PLEOSPORA HERBARUM; STREPTOMYCES GRISEUS; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII; TRICHOTHECIUM ROSEUM .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0036_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0036 HUMAN PRESCRIPTION DRUG B Mold Mixture B Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SPICIFER; COLLETOTRICHUM COCCODES; HYPOMYCES PERNICIOSUS; KHUSKIA ORYZAE; MICROASCUS BREVICAULIS; MYROTHECIUM VERRUCARIA; NEUROSPORA CRASSA; PAECILOMYCES VARIOTII; PASSALORA FULVA; PLEOSPORA HERBARUM; STREPTOMYCES GRISEUS; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII; TRICHOTHECIUM ROSEUM .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0037_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0037 HUMAN PRESCRIPTION DRUG B Mold Mixture B Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SPICIFER; COLLETOTRICHUM COCCODES; HYPOMYCES PERNICIOSUS; KHUSKIA ORYZAE; MICROASCUS BREVICAULIS; MYROTHECIUM VERRUCARIA; NEUROSPORA CRASSA; PAECILOMYCES VARIOTII; PASSALORA FULVA; PLEOSPORA HERBARUM; STREPTOMYCES GRISEUS; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII; TRICHOTHECIUM ROSEUM .0018; .0018; .0018; .0018; .0018; .0018; .0018; .0036; .0018; .0018; .0018; .0018; .0018; .0018 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0038_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0038 HUMAN PRESCRIPTION DRUG Botrytis Botrytis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. BOTRYTIS CINEREA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0039_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0039 HUMAN PRESCRIPTION DRUG Botrytis Botrytis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BOTRYTIS CINEREA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0040_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0040 HUMAN PRESCRIPTION DRUG Banana Banana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BANANA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0041_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0041 HUMAN PRESCRIPTION DRUG Basil Basil INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BASIL .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 49288-0042_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0042 HUMAN PRESCRIPTION DRUG Whole Grain Barley Whole Grain Barley INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BARLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 49288-0043_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0043 HUMAN PRESCRIPTION DRUG Lima Bean Lima Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LIMA BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 49288-0044_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0044 HUMAN PRESCRIPTION DRUG Mung Bean Mung Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MUNG BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 49288-0045_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0045 HUMAN PRESCRIPTION DRUG Navy Bean Navy Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0046_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0046 HUMAN PRESCRIPTION DRUG Pinto Bean Pinto Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0047_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0047 HUMAN PRESCRIPTION DRUG Green (Sting) Bean Green (String) Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. STRING BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 49288-0048_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0048 HUMAN PRESCRIPTION DRUG Soybean Soybean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SOYBEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0049_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0049 HUMAN PRESCRIPTION DRUG Broccoli Broccoli INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BROCCOLI .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0050_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0050 HUMAN PRESCRIPTION DRUG Brussels Sprout Brussels Sprout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BRUSSELS SPROUT .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0051_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0051 HUMAN PRESCRIPTION DRUG Buckwheat Buckwheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BUCKWHEAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 49288-0052_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0052 HUMAN PRESCRIPTION DRUG Beet Beet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BEET .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0053_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0053 HUMAN PRESCRIPTION DRUG Brazil Nut Meat Brazil Nut Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BRAZIL NUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 49288-0054_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0054 HUMAN PRESCRIPTION DRUG Blackberry Blackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BLACKBERRY .05 g/mL 49288-0055_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0055 HUMAN PRESCRIPTION DRUG Blueberry Blueberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BLUEBERRY .05 g/mL 49288-0056_13c9eea1-38b5-472b-b735-a814ca886718 49288-0056 HUMAN PRESCRIPTION DRUG Birch Mixture Birch Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BETULA ALLEGHANIENSIS POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA PAPYRIFERA POLLEN; BETULA POPULIFOLIA POLLEN .0083; .0083; .0083; .0083; .0083; .0083 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0057_13c9eea1-38b5-472b-b735-a814ca886718 49288-0057 HUMAN PRESCRIPTION DRUG Birch Mixture Birch Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BETULA ALLEGHANIENSIS POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA PAPYRIFERA POLLEN; BETULA POPULIFOLIA POLLEN .0033; .0033; .0033; .0033; .0033; .0033 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0058_13c9eea1-38b5-472b-b735-a814ca886718 49288-0058 HUMAN PRESCRIPTION DRUG Spring (Water) Birch Spring (Water) Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BETULA OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0059_13c9eea1-38b5-472b-b735-a814ca886718 49288-0059 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0060_13c9eea1-38b5-472b-b735-a814ca886718 49288-0060 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0061_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0061 HUMAN PRESCRIPTION DRUG Kidney Bean Kidney Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0062_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0062 HUMAN PRESCRIPTION DRUG Canadian Bluegrass Canadian Bluegrass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POA COMPRESSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0063_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0063 HUMAN PRESCRIPTION DRUG Standardized Bermuda Grass Pollen Standardized Bermuda Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102226 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0064_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0064 HUMAN PRESCRIPTION DRUG Bermuda Grass Smut Bermuda Grass Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO CYNODONTIS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0065_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0065 HUMAN PRESCRIPTION DRUG Bermuda Grass Smut Bermuda Grass Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO CYNODONTIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0066_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0066 HUMAN PRESCRIPTION DRUG Barley Smut Barley Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO NUDA HORDEI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0067_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0067 HUMAN PRESCRIPTION DRUG Annual Bluegrass Annual Bluegrass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POA ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0068_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0068 HUMAN PRESCRIPTION DRUG Cheat Brome Grass Cheat Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BROMUS SECALINUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0069_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0069 HUMAN PRESCRIPTION DRUG Smooth Brome Grass Smooth Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0070_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0070 HUMAN PRESCRIPTION DRUG Beef Beef INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BEEF .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 49288-0071_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0071 HUMAN PRESCRIPTION DRUG Bay Leaf Bay Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LAURUS NOBILIS .05 g/mL 49288-0072_13c9eea1-38b5-472b-b735-a814ca886718 49288-0072 HUMAN PRESCRIPTION DRUG Paperbark Birch Paperbark Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19770809 BLA BLA102223 Antigen Laboratories, Inc. BETULA PAPYRIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0073_13c9eea1-38b5-472b-b735-a814ca886718 49288-0073 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0074_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0074 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PASPALUM NOTATUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0075_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0075 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PASPALUM NOTATUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0076_13c9eea1-38b5-472b-b735-a814ca886718 49288-0076 HUMAN PRESCRIPTION DRUG Groundsel Tree Groundsel Tree INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0077_13c9eea1-38b5-472b-b735-a814ca886718 49288-0077 HUMAN PRESCRIPTION DRUG Red (River) Birch Red (River) Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. BETULA NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0078_13c9eea1-38b5-472b-b735-a814ca886718 49288-0078 HUMAN PRESCRIPTION DRUG Red (River) Birch Red (River) Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BETULA NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0079_bffa4c39-d658-4a1c-b00a-3f0c411fa524 49288-0079 HUMAN PRESCRIPTION DRUG Bayberry Pollen Bayberry Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MORELLA CERIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0080_13c9eea1-38b5-472b-b735-a814ca886718 49288-0080 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BETULA POPULIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0081_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0081 HUMAN PRESCRIPTION DRUG Sugar Beet Pollen Sugar Beet Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BETA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0082_13c9eea1-38b5-472b-b735-a814ca886718 49288-0082 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. POPULUS DELTOIDES POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0083_13c9eea1-38b5-472b-b735-a814ca886718 49288-0083 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0084_13c9eea1-38b5-472b-b735-a814ca886718 49288-0084 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POPULUS DELTOIDES POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0085_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0085 HUMAN PRESCRIPTION DRUG Chenopodium Mixture Chenopodium Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; CHENOPODIUM BOTRYS POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0086_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0086 HUMAN PRESCRIPTION DRUG Chenopodium Mixture Chenopodium Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; CHENOPODIUM BOTRYS POLLEN .0067; .0067; .0067 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0087_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0087 HUMAN PRESCRIPTION DRUG Cephalosporium Cephalosporium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ACREMONIUM STRICTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0088_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0088 HUMAN PRESCRIPTION DRUG Cephalosporium Cephalosporium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACREMONIUM STRICTUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0089_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0089 HUMAN PRESCRIPTION DRUG Cephalosporium Cephalosporium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACREMONIUM STRICTUM .025 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0090_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0090 HUMAN PRESCRIPTION DRUG C Mold Mixture C Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ACROTHECIUM ROBUSTUM; APIOSPORA MONTAGNEI; HUMICOLA GRISEA; MICROSPORUM AUDOUINII; MICROSPORUM CANIS; MYCOCLADUS CORYMBIFERUS; PHYCOMYCES BLAKESLEEANUS; SPOROTRICHUM PRUINOSUM; STACHYBOTRYS CHARTARUM; SYNCEPHALASTRUM RACEMOSUM; TETRACOCCOSPORIUM PAXIANUM; VERTICILLIUM ALBO-ATRUM .0083; .0083; .0083; .0083; .0083; .0083; .0083; .0083; .0083; .0083; .0083; .0083 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0091_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0091 HUMAN PRESCRIPTION DRUG C Mold Mixture C Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACROTHECIUM ROBUSTUM; APIOSPORA MONTAGNEI; HUMICOLA GRISEA; MICROSPORUM AUDOUINII; MICROSPORUM CANIS; MYCOCLADUS CORYMBIFERUS; PHYCOMYCES BLAKESLEEANUS; SPOROTRICHUM PRUINOSUM; STACHYBOTRYS CHARTARUM; SYNCEPHALASTRUM RACEMOSUM; TETRACOCCOSPORIUM PAXIANUM; VERTICILLIUM ALBO-ATRUM .0042; .0042; .0042; .0042; .0042; .0042; .0042; .0042; .0042; .0042; .0042; .0042 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0092_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0092 HUMAN PRESCRIPTION DRUG C Mold Mixture C Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACROTHECIUM ROBUSTUM; APIOSPORA MONTAGNEI; HUMICOLA GRISEA; MICROSPORUM AUDOUINII; MICROSPORUM CANIS; MYCOCLADUS CORYMBIFERUS; PHYCOMYCES BLAKESLEEANUS; SPOROTRICHUM PRUINOSUM; STACHYBOTRYS CHARTARUM; SYNCEPHALASTRUM RACEMOSUM; TETRACOCCOSPORIUM PAXIANUM; VERTICILLIUM ALBO-ATRUM .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0093_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0093 HUMAN PRESCRIPTION DRUG Chaetomium Chaetomium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CHAETOMIUM GLOBOSUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0094_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0094 HUMAN PRESCRIPTION DRUG Chaetomium Chaetomium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CHAETOMIUM GLOBOSUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0095_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0095 HUMAN PRESCRIPTION DRUG Cephalothecium Cephalothecium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRICHOTHECIUM ROSEUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0096_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0096 HUMAN PRESCRIPTION DRUG Cladosporium fulvum Cladosporium fulvum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PASSALORA FULVA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0097_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0097 HUMAN PRESCRIPTION DRUG Curvularia Curvularia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SPICIFER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0098_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0098 HUMAN PRESCRIPTION DRUG Curvularia Curvularia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SPICIFER .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0099_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0099 HUMAN PRESCRIPTION DRUG Corn Corn INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CORN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 49288-0100_afc65820-1d95-4bc6-81a6-ef5ca82cbd81 49288-0100 HUMAN PRESCRIPTION DRUG Coffee Coffee INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ARABICA COFFEE BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 49288-0101_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0101 HUMAN PRESCRIPTION DRUG Cabbage Cabbage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CABBAGE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0102_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0102 HUMAN PRESCRIPTION DRUG Cantaloupe Cantaloupe INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CANTALOUPE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0103_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0103 NON-STANDARDIZED ALLERGENIC Carp Carp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COMMON CARP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 49288-0104_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0104 HUMAN PRESCRIPTION DRUG Carrot Carrot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARROT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0105_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0105 HUMAN PRESCRIPTION DRUG Cashew Nut Meat Cashew Nut Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CASHEW .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 49288-0106_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0106 NON-STANDARDIZED ALLERGENIC Catfish Catfish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. WHITE CATFISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 49288-0107_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0107 HUMAN PRESCRIPTION DRUG Cauliflower Cauliflower INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CAULIFLOWER .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0108_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0108 HUMAN PRESCRIPTION DRUG Celery Celery INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CELERY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0109_80e3a713-b3c2-4981-9f01-d987196bc528 49288-0109 HUMAN PRESCRIPTION DRUG Carob Carob INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CAROB .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 49288-0110_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0110 HUMAN PRESCRIPTION DRUG Cherry Cherry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SWEET CHERRY .05 g/mL 49288-0111_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0111 NON-STANDARDIZED ALLERGENIC Clam Clam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUAHOG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 49288-0112_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0112 HUMAN PRESCRIPTION DRUG Clove Clove INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CLOVE .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 49288-0113_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0113 HUMAN PRESCRIPTION DRUG Chicken Chicken INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CHICKEN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 49288-0114_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0114 HUMAN PRESCRIPTION DRUG Cinnamon Cinnamon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CINNAMON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0115_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0115 HUMAN PRESCRIPTION DRUG Whole Bean Cacao Whole Bean Cacao INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COCOA BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 49288-0116_afc65820-1d95-4bc6-81a6-ef5ca82cbd81 49288-0116 HUMAN PRESCRIPTION DRUG Cottonseed Cottonseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COTTON SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 49288-0117_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0117 HUMAN PRESCRIPTION DRUG Cranberry Cranberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CRANBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0118_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0118 HUMAN PRESCRIPTION DRUG Cucumber Cucumber INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CUCUMBER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0119_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0119 NON-STANDARDIZED ALLERGENIC Crab Crab INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20110722 BLA BLA102223 Antigen Laboratories, Inc. OPILIO CRAB .05 g/mL 49288-0120_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0120 HUMAN PRESCRIPTION DRUG Coconut Coconut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COCONUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0121_bc075035-e18d-4cbd-be9d-d4d75cb7c2d1 49288-0121 HUMAN PRESCRIPTION DRUG Standardized Cat Hair Standardized Cat Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19921021 BLA BLA103368 Antigen Laboratories, Inc. FELIS CATUS HAIR 10000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] 49288-0122_bc075035-e18d-4cbd-be9d-d4d75cb7c2d1 49288-0122 HUMAN PRESCRIPTION DRUG Standardized Cat Hair Standardized Cat Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19921021 BLA BLA103368 Antigen Laboratories, Inc. FELIS CATUS HAIR 5000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] 49288-0123_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0123 HUMAN PRESCRIPTION DRUG Cattle Hair Cattle Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. BOS TAURUS HAIR .1 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient] 49288-0124_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0124 HUMAN PRESCRIPTION DRUG Cattle Hair Cattle Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BOS TAURUS HAIR .05 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient] 49288-0125_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0125 HUMAN PRESCRIPTION DRUG Chicken Feather Chicken Feather INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GALLUS GALLUS FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0126_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0126 HUMAN PRESCRIPTION DRUG Chicken Feather Chicken Feather INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GALLUS GALLUS FEATHER .02 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0127_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0127 HUMAN PRESCRIPTION DRUG Canary Feather Canary Feather INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SERINUS CANARIA FEATHER .02 g/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Allergens [Chemical/Ingredient] 49288-0128_13c9eea1-38b5-472b-b735-a814ca886718 49288-0128 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS ASHEI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0129_13c9eea1-38b5-472b-b735-a814ca886718 49288-0129 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0130_13c9eea1-38b5-472b-b735-a814ca886718 49288-0130 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS ASHEI POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0131_13c9eea1-38b5-472b-b735-a814ca886718 49288-0131 HUMAN PRESCRIPTION DRUG Redberry Juniper Redberry Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0132_13c9eea1-38b5-472b-b735-a814ca886718 49288-0132 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0133_13c9eea1-38b5-472b-b735-a814ca886718 49288-0133 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TAMARIX GALLICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0134_13c9eea1-38b5-472b-b735-a814ca886718 49288-0134 HUMAN PRESCRIPTION DRUG Black Cottonwood Black Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0135_13c9eea1-38b5-472b-b735-a814ca886718 49288-0135 HUMAN PRESCRIPTION DRUG Western Cottonwood Western Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0136_13c9eea1-38b5-472b-b735-a814ca886718 49288-0136 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0137_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0137 HUMAN PRESCRIPTION DRUG Lambs Quarters Lambs Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM ALBUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0138_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0138 HUMAN PRESCRIPTION DRUG Lambs Quarters Lambs Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0139_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0139 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0140_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0140 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0141_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0141 HUMAN PRESCRIPTION DRUG Corn Pollen Corn Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ZEA MAYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0142_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0142 HUMAN PRESCRIPTION DRUG Sweet Clover Mixture Sweet Clover Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740325 BLA BLA102223 Antigen Laboratories, Inc. MELILOTUS ALBUS POLLEN; MELILOTUS OFFICINALIS POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0143_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0143 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19770909 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO MAYDIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0144_13c9eea1-38b5-472b-b735-a814ca886718 49288-0144 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TAXODIUM DISTICHUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0145_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0145 HUMAN PRESCRIPTION DRUG Reed Canary Grass Reed Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0146_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0146 HUMAN PRESCRIPTION DRUG Cattail Cattail INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TYPHA LATIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0147_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0147 NON-STANDARDIZED ALLERGENIC Cod Cod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ATLANTIC COD .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 49288-0148_0c2a583c-28b8-4184-9f4d-9feba1e683c9 49288-0148 HUMAN PRESCRIPTION DRUG American Cockroach American Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PERIPLANETA AMERICANA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0149_0c2a583c-28b8-4184-9f4d-9feba1e683c9 49288-0149 HUMAN PRESCRIPTION DRUG American Cockroach American Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PERIPLANETA AMERICANA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0150_0c2a583c-28b8-4184-9f4d-9feba1e683c9 49288-0150 HUMAN PRESCRIPTION DRUG American Cockroach American Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PERIPLANETA AMERICANA .02 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0151_80e3a713-b3c2-4981-9f01-d987196bc528 49288-0151 HUMAN PRESCRIPTION DRUG Currant Currant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RED CURRANT .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 49288-0152_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0152 HUMAN PRESCRIPTION DRUG Caraway Seed Caraway Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARAWAY .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 49288-0153_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0153 HUMAN PRESCRIPTION DRUG Mexican Tea Mexican Tea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0154_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0154 HUMAN PRESCRIPTION DRUG Cotton Linters Cotton Linters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COTTON FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0155_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0155 HUMAN PRESCRIPTION DRUG Cumin Cumin INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CUMIN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 49288-0156_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0156 HUMAN PRESCRIPTION DRUG Yellow Sweet Clover Yellow Sweet Clover INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MELILOTUS OFFICINALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0157_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0157 HUMAN PRESCRIPTION DRUG White Sweet Clover White Sweet Clover INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MELILOTUS ALBUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0158_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0158 HUMAN PRESCRIPTION DRUG Cladosporium herbarum Cladosporium herbarum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CLADOSPORIUM HERBARUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0159_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0159 HUMAN PRESCRIPTION DRUG Cladosporium herbarum Cladosporium herbarum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CLADOSPORIUM HERBARUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0160_993fabf7-14f0-4417-9838-d1a609628cb5 49288-0160 HUMAN PRESCRIPTION DRUG Cricket Cricket INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACHETA DOMESTICUS .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0161_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0161 HUMAN PRESCRIPTION DRUG Date Date INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. DATE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0162_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0162 HUMAN PRESCRIPTION DRUG Dill Seed Dill Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740326 BLA BLA102223 Antigen Laboratories, Inc. DILL .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 49288-0163_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0163 HUMAN PRESCRIPTION DRUG Duck Meat Duck Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. DUCK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 49288-0164_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0164 HUMAN PRESCRIPTION DRUG Dog Hair Dog Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR .1 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0165_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0165 HUMAN PRESCRIPTION DRUG Dog Hair Dog Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR .05 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0166_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0166 HUMAN PRESCRIPTION DRUG Dog Hair Dog Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR .02 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0167_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0167 HUMAN PRESCRIPTION DRUG Duck Feather Duck Feather INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0168_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0168 HUMAN PRESCRIPTION DRUG Deer Hair Deer Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ODOCOILEUS VIRGINIANUS HAIR .05 g/mL 49288-0169_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0169 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TARAXACUM OFFICINALE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0170_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0170 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RUMEX CRISPUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0171_a1f5af98-9952-4103-a728-433b94a14e0a 49288-0171 HUMAN PRESCRIPTION DRUG Grain Mill Dust Grain Mill Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GRAIN MILL DUST .02 g/mL 49288-0172_745162a9-2fdc-4b03-a3bc-32d410b3d9c1 49288-0172 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides pteronyssinus Standardized Mite, Dermatophagoides pteronyssinus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19911022 BLA BLA102225 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0173_745162a9-2fdc-4b03-a3bc-32d410b3d9c1 49288-0173 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides pteronyssinus Standardized Mite, Dermatophagoides pteronyssinus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920206 BLA BLA102225 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 3000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0174_745162a9-2fdc-4b03-a3bc-32d410b3d9c1 49288-0174 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides pteronyssinus Standardized Mite, Dermatophagoides pteronyssinus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19911022 BLA BLA102225 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 5000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0175_745162a9-2fdc-4b03-a3bc-32d410b3d9c1 49288-0175 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides farinae Standardized Mite, Dermatophagoides farinae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19911022 BLA BLA102224 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0176_745162a9-2fdc-4b03-a3bc-32d410b3d9c1 49288-0176 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides farinae Standardized Mite, Dermatophagoides farinae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920206 BLA BLA102224 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE 3000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0177_745162a9-2fdc-4b03-a3bc-32d410b3d9c1 49288-0177 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides farinae Standardized Mite, Dermatophagoides farinae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19911022 BLA BLA102224 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE 5000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0178_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0178 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. RUMEX ACETOSELLA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 49288-0179_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0179 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RUMEX ACETOSELLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 49288-0180_89b69938-05fc-4bd8-9c55-4fb46e9018c7 49288-0180 HUMAN PRESCRIPTION DRUG A. Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HOUSE DUST .1 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 49288-0181_89b69938-05fc-4bd8-9c55-4fb46e9018c7 49288-0181 HUMAN PRESCRIPTION DRUG A. Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HOUSE DUST .05 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 49288-0182_745162a9-2fdc-4b03-a3bc-32d410b3d9c1 49288-0182 HUMAN PRESCRIPTION DRUG Mixture of Standardized Mites Mixture of Standardized Mites INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19911022 BLA BLA102225 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 5000; 5000 [AU]/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0183_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0183 HUMAN PRESCRIPTION DRUG Dock/Sorrel Mixture Dock/Sorrel Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20070716 BLA BLA102223 Antigen Laboratories, Inc. RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 49288-0184_13c9eea1-38b5-472b-b735-a814ca886718 49288-0184 HUMAN PRESCRIPTION DRUG Elm Mixture Elm Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0185_13c9eea1-38b5-472b-b735-a814ca886718 49288-0185 HUMAN PRESCRIPTION DRUG Elm Mixture Elm Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN .01; .01 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0186_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0186 HUMAN PRESCRIPTION DRUG Epicoccum Epicoccum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. EPICOCCUM NIGRUM .1 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49288-0187_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0187 HUMAN PRESCRIPTION DRUG Epicoccum Epicoccum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EPICOCCUM NIGRUM .05 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49288-0188_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0188 HUMAN PRESCRIPTION DRUG Egg White Egg White INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EGG WHITE .05 g/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 49288-0189_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0189 HUMAN PRESCRIPTION DRUG Whole Egg Whole Egg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EGG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] 49288-0190_13c9eea1-38b5-472b-b735-a814ca886718 49288-0190 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ULMUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0191_13c9eea1-38b5-472b-b735-a814ca886718 49288-0191 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ULMUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0192_13c9eea1-38b5-472b-b735-a814ca886718 49288-0192 HUMAN PRESCRIPTION DRUG Chinese (Siberian) Elm Chinese (Siberian) Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ULMUS PUMILA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0193_13c9eea1-38b5-472b-b735-a814ca886718 49288-0193 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0194_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0194 HUMAN PRESCRIPTION DRUG Epidermophyton Epidermophyton INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EPIDERMOPHYTON FLOCCOSUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0195_13c9eea1-38b5-472b-b735-a814ca886718 49288-0195 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0196_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0196 HUMAN PRESCRIPTION DRUG Eggplant Eggplant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EGGPLANT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0197_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0197 HUMAN PRESCRIPTION DRUG Fusarium oxysporum Fusarium oxysporum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FUSARIUM OXYSPORUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0198_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0198 HUMAN PRESCRIPTION DRUG Fusarium oxysporum Fusarium oxysporum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FUSARIUM OXYSPORUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0199_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0199 HUMAN PRESCRIPTION DRUG Filbert Nut Meat Filbert Nut Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HAZELNUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 49288-0200_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0200 NON-STANDARDIZED ALLERGENIC Flounder Flounder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FLOUNDER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 49288-0201_afc65820-1d95-4bc6-81a6-ef5ca82cbd81 49288-0201 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FLAX SEED .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 49288-0202_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0202 HUMAN PRESCRIPTION DRUG Franseria Mixture Franseria Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DELTOIDEA POLLEN; AMBROSIA DUMOSA POLLEN .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0203_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0203 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0204_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0204 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0205_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0205 HUMAN PRESCRIPTION DRUG Standardized Meadow Fescue Grass Pollen Standardized Meadow Fescue Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102227 Antigen Laboratories, Inc. FESTUCA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0206_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0206 HUMAN PRESCRIPTION DRUG Feather Mixture Feather Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; GALLUS GALLUS FEATHER .0333; .0333; .0333 g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0207_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0207 HUMAN PRESCRIPTION DRUG Feather Mixture Feather Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; GALLUS GALLUS FEATHER .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0208_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0208 HUMAN PRESCRIPTION DRUG Rabbit Bush Rabbit Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0209_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0209 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0210_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0210 HUMAN PRESCRIPTION DRUG Number Four Mold Mixture Number Four Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM ROQUEFORTI .0125; .0031; .0031; .0031; .0031; .0125; .0021; .0021; .0021; .0021; .0021; .0021 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0211_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0211 HUMAN PRESCRIPTION DRUG Grain Smut Mixture Grain Smut Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .025; .025; .025; .025 g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0212_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0212 HUMAN PRESCRIPTION DRUG Grain Smut Mixture Grain Smut Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970909 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0213_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0213 HUMAN PRESCRIPTION DRUG Grain Smut Mixture Grain Smut Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970909 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .005; .005; .005; .005 g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0214_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0214 HUMAN PRESCRIPTION DRUG Grass Smut Mixture Grass Smut Mixture INJECTION, SOLUTION SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .05; .05 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0215_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0215 HUMAN PRESCRIPTION DRUG Grass Smut Mixture Grass Smut Mixture INJECTION, SOLUTION SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .025; .025 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0216_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0216 HUMAN PRESCRIPTION DRUG Grass Smut Mixture Grass Smut Mixture INJECTION, SOLUTION SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .01; .01 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0217_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0217 HUMAN PRESCRIPTION DRUG Gliocladium Gliocladium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MYROTHECIUM VERRUCARIA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0218_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0218 HUMAN PRESCRIPTION DRUG Garlic Garlic INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GARLIC .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 49288-0219_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0219 HUMAN PRESCRIPTION DRUG Ginger Ginger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GINGER .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 49288-0220_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0220 HUMAN PRESCRIPTION DRUG Goose Meat Goose Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GOOSE .05 g/mL 49288-0221_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0221 HUMAN PRESCRIPTION DRUG Concord Grape Concord Grape INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CONCORD GRAPE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0222_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0222 HUMAN PRESCRIPTION DRUG Grapefruit Grapefruit INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GRAPEFRUIT 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0223_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0223 HUMAN PRESCRIPTION DRUG Grapefruit Grapefruit INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GRAPEFRUIT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0224_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0224 HUMAN PRESCRIPTION DRUG Goat Hair Goat Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CAPRA HIRCUS HAIR .05 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0225_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0225 HUMAN PRESCRIPTION DRUG Goose Feather Goose Feather INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ANSER ANSER FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0226_13c9eea1-38b5-472b-b735-a814ca886718 49288-0226 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0227_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0227 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0228_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0228 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GEOTRICHUM CANDIDUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0229_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0229 HUMAN PRESCRIPTION DRUG Guinea Pig Hair Guinea Pig Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CAVIA PORCELLUS HAIR .1 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient] 49288-0230_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0230 HUMAN PRESCRIPTION DRUG Guinea Pig Hair Guinea Pig Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CAVIA PORCELLUS HAIR .05 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient] 49288-0231_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0231 HUMAN PRESCRIPTION DRUG White Grape White Grape INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. WINE GRAPE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0232_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0232 HUMAN PRESCRIPTION DRUG Mixture of Four Standardized Grasses Mixture of Four Standardized Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA103421 Antigen Laboratories, Inc. AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 25000; 25000; 25000; 25000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0233_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0233 HUMAN PRESCRIPTION DRUG Mixture of Five Standardized Grasses Mixture of Five Standardized Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA103421 Antigen Laboratories, Inc. AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 20000; 20000; 20000; 20000; 20000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0234_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0234 HUMAN PRESCRIPTION DRUG Mixture of Six Standardized Grasses Mixture of Six Standardized Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA103421 Antigen Laboratories, Inc. AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 16667; 16667; 16667; 16667; 16667; 16667 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0235_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0235 HUMAN PRESCRIPTION DRUG Mixture of Seven Standardized Grasses Mixture of Seven Standardized Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA103421 Antigen Laboratories, Inc. AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 14286; 14286; 14286; 14286; 14286; 14286; 14286 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0236_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0236 HUMAN PRESCRIPTION DRUG Mixture of Eight Standardized Grasses Mixture of Eight Standardized Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102226 Antigen Laboratories, Inc. AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 12500; 12500; 1250; 12500; 12500; 12500; 12500; 12500 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0238_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0238 HUMAN PRESCRIPTION DRUG Number Fourteen Grass Mixture Number Fourteen Grass Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102223 Antigen Laboratories, Inc. ARRHENATHERUM ELATIUS POLLEN; BROMUS INERMIS POLLEN; BROMUS SECALINUS POLLEN; ELYMUS REPENS POLLEN; HOLCUS LANATUS POLLEN; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; POA COMPRESSA POLLEN; SECALE CEREALE POLLEN; SORGHUM BICOLOR SSP. DRUMMONDII POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; TYPHA LATIFOLIA POLLEN; ZEA MAYS POLLEN .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0239_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0239 HUMAN PRESCRIPTION DRUG Mixture of Standardized and Non-Standardized Southern Grasses Mixture of Standardized and Non-Standardized Southern Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102226 Antigen Laboratories, Inc. AGROSTIS GIGANTEA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN 16667; 1667; 16667; 16667; 16667; .0083 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0240_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0240 HUMAN PRESCRIPTION DRUG Mixture of Twenty-Two Standardized and Non-Standardized Grasses Mixture of Twenty-Two Standardized and Non-Standardized Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102226 Antigen Laboratories, Inc. AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARRHENATHERUM ELATIUS POLLEN; BROMUS INERMIS POLLEN; BROMUS SECALINUS POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; ELYMUS REPENS POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; POA COMPRESSA POLLEN; POA PRATENSIS POLLEN; SECALE CEREALE POLLEN; SORGHUM BICOLOR SSP. DRUMMONDII POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; TYPHA LATIFOLIA POLLEN; ZEA MAYS POLLEN 4545; 4545; .00227; .00227; .00227; 455; 4545; .00227; 4545; .00227; 4545; .00227; .00227; 4545; .00227; 4545; .00227; .00227; .00227; .00227; .00227; .00227 [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] 49288-0241_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0241 HUMAN PRESCRIPTION DRUG Mixture of Standardized and Non-Standardized Inland Grasses Mixture of Standardized and Non-Standardized Inland Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA103421 Antigen Laboratories, Inc. AGROSTIS GIGANTEA POLLEN; BROMUS INERMIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA COMPRESSA POLLEN; POA PRATENSIS POLLEN 14286; .0071; 14286; 14286; 14286; .0071; 14286 [BAU]/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0242_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0242 HUMAN PRESCRIPTION DRUG Mixture of Standardized and Non-Standardized Coastal Grasses Mixture of Standardized and Non-Standardized Coastal Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA103421 Antigen Laboratories, Inc. AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARRHENATHERUM ELATIUS POLLEN; DACTYLIS GLOMERATA POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA COMPRESSA POLLEN; POA PRATENSIS POLLEN 11111; 11111; .0056; 11111; .0056; 11111; 11111; .0056; 11111 [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0243_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0243 HUMAN PRESCRIPTION DRUG Mixture of Standardized and Non-Standardized Southeastern Grasses Mixture of Standardized and Non-Standardized Southeastern Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102226 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; PASPALUM NOTATUM POLLEN; PHLEUM PRATENSE POLLEN 3333; .0167; 33333 [BAU]/mL; g/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0244_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0244 HUMAN PRESCRIPTION DRUG Hormodendrum Hormodendrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0245_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0245 HUMAN PRESCRIPTION DRUG Hormodendrum Hormodendrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0246_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0246 HUMAN PRESCRIPTION DRUG Hormodendrum Hormodendrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES .025 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0247_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0247 HUMAN PRESCRIPTION DRUG Helminthosporium Helminthosporium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SATIVUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0248_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0248 HUMAN PRESCRIPTION DRUG Helminthosporium Helminthosporium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SATIVUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0249_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0249 HUMAN PRESCRIPTION DRUG Helminthosporium Helminthosporium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SATIVUS .025 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0250_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0250 NON-STANDARDIZED ALLERGENIC Haddock Haddock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HADDOCK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 49288-0251_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0251 NON-STANDARDIZED ALLERGENIC Halibut Halibut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PACIFIC HALIBUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 49288-0252_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0252 NON-STANDARDIZED ALLERGENIC Halibut Halibut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PACIFIC HALIBUT .02 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 49288-0253_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0253 NON-STANDARDIZED ALLERGENIC Herring Herring INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HERRING .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 49288-0254_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0254 HUMAN PRESCRIPTION DRUG Hops Hops INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HOPS .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 49288-0255_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0255 HUMAN PRESCRIPTION DRUG Horse Hair Horse Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. EQUUS CABALLUS HAIR .1 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0256_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0256 HUMAN PRESCRIPTION DRUG Horse Hair Horse Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EQUUS CABALLUS HAIR .05 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0257_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0257 HUMAN PRESCRIPTION DRUG Horse Hair Horse Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EQUUS CABALLUS HAIR .02 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0258_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0258 HUMAN PRESCRIPTION DRUG Hog Hair Hog Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. SUS SCROFA HAIR .1 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0259_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0259 HUMAN PRESCRIPTION DRUG Hog Hair Hog Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SUS SCROFA HAIR .05 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0260_13c9eea1-38b5-472b-b735-a814ca886718 49288-0260 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0261_13c9eea1-38b5-472b-b735-a814ca886718 49288-0261 HUMAN PRESCRIPTION DRUG Hazelnut Pollen Hazelnut Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CORYLUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0262_13c9eea1-38b5-472b-b735-a814ca886718 49288-0262 HUMAN PRESCRIPTION DRUG Hickory Pollen Mixture Hickory Pollen Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARYA ALBA POLLEN; CARYA CORDIFORMIS POLLEN; CARYA GLABRA POLLEN; CARYA OVATA POLLEN .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0263_13c9eea1-38b5-472b-b735-a814ca886718 49288-0263 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARYA OVATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0264_13c9eea1-38b5-472b-b735-a814ca886718 49288-0264 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CARYA ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0265_13c9eea1-38b5-472b-b735-a814ca886718 49288-0265 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARYA ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0266_13c9eea1-38b5-472b-b735-a814ca886718 49288-0266 HUMAN PRESCRIPTION DRUG Hickory/Pecan Mixture Hickory/Pecan Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19960712 BLA BLA102223 Antigen Laboratories, Inc. CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0267_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0267 HUMAN PRESCRIPTION DRUG Marsh Elder Mixture Marsh Elder Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN; IVA XANTHIFOLIA POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0268_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0268 HUMAN PRESCRIPTION DRUG Marsh Elder Mixture Marsh Elder Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN; IVA XANTHIFOLIA POLLEN .01; .01 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0269_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0269 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. IVA XANTHIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0270_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0270 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0271_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0271 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0272_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0272 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CORCORUS CAPSULARIS FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0273_13c9eea1-38b5-472b-b735-a814ca886718 49288-0273 HUMAN PRESCRIPTION DRUG Oneseed Juniper Oneseed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0274_13c9eea1-38b5-472b-b735-a814ca886718 49288-0274 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0275_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0275 HUMAN PRESCRIPTION DRUG Johnson Grass Pollen Johnson Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. SORGHUM HALEPENSE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0276_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0276 HUMAN PRESCRIPTION DRUG Johnson Grass Pollen Johnson Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SORGHUM HALEPENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0277_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0277 HUMAN PRESCRIPTION DRUG Standardized Kentucky (June) Bluegrass Standardized Kentucky (June) Bluegrass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA103421 Antigen Laboratories, Inc. POA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0278_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0278 HUMAN PRESCRIPTION DRUG Johnson Grass Smut Johnson Grass Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. SPORISORIUM CRUENTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0279_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0279 HUMAN PRESCRIPTION DRUG Johnson Grass Smut Johnson Grass Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SPORISORIUM CRUENTUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0280_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0280 HUMAN PRESCRIPTION DRUG Johnson Grass Smut Johnson Grass Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SPORISORIUM CRUENTUM .02 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0281_13c9eea1-38b5-472b-b735-a814ca886718 49288-0281 HUMAN PRESCRIPTION DRUG Western (Sierra) Juniper Western (Sierra) Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0282_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0282 HUMAN PRESCRIPTION DRUG Kochia Kochia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. KOCHIA SCOPARIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0283_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0283 HUMAN PRESCRIPTION DRUG Kochia Kochia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. KOCHIA SCOPARIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0284_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0284 HUMAN PRESCRIPTION DRUG Kochia Kochia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. KOCHIA SCOPARIA POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0285_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0285 HUMAN PRESCRIPTION DRUG Kapok Kapok INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CEIBA PENTANDRA FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0286_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0286 HUMAN PRESCRIPTION DRUG Lettuce Lettuce INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LETTUCE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0287_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0287 HUMAN PRESCRIPTION DRUG Lamb Lamb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LAMB .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 49288-0288_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0288 HUMAN PRESCRIPTION DRUG Lemon Lemon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LEMON 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0289_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0289 HUMAN PRESCRIPTION DRUG Lime Lime INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LIME (CITRUS) 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0290_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0290 HUMAN PRESCRIPTION DRUG Lentil Lentil INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LENTIL .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 49288-0291_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0291 NON-STANDARDIZED ALLERGENIC Lobster Lobster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LOBSTER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 49288-0292_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0292 HUMAN PRESCRIPTION DRUG Malt Malt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MALT EXTRACT, BARLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 49288-0293_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0293 HUMAN PRESCRIPTION DRUG Monilia Mixture Monilia Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA .025; .025 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0294_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0294 HUMAN PRESCRIPTION DRUG Mucor Mixture Mucor Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. MUCOR PLUMBEUS; MUCOR RACEMOSUS; RHIZOPUS STOLONIFER .0333; .0333; .0333 g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0295_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0295 HUMAN PRESCRIPTION DRUG Mucor Mixture Mucor Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MUCOR PLUMBEUS; MUCOR RACEMOSUS; RHIZOPUS STOLONIFER .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0296_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0296 HUMAN PRESCRIPTION DRUG Mycogone perniciosa Mycogone perniciosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. HYPOMYCES PERNICIOSUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0297_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0297 HUMAN PRESCRIPTION DRUG Mycogone perniciosa Mycogone perniciosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HYPOMYCES PERNICIOSUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0298_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0298 HUMAN PRESCRIPTION DRUG Microsporum audouinii Microsporum audouinii INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MICROSPORUM AUDOUINII .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0299_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0299 HUMAN PRESCRIPTION DRUG Microsporum canis Microsporum canis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MICROSPORUM CANIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0300_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0300 HUMAN PRESCRIPTION DRUG Honeydew Melon Honeydew Melon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HONEYDEW MELON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0301_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0301 HUMAN PRESCRIPTION DRUG Cow Milk Cow Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COW MILK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] 49288-0302_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0302 HUMAN PRESCRIPTION DRUG Goat Milk Goat Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GOAT MILK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] 49288-0303_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0303 HUMAN PRESCRIPTION DRUG Millet Millet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MILLET SEED .05 g/mL 49288-0304_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0304 HUMAN PRESCRIPTION DRUG Mint Mint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SPEARMINT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 49288-0305_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0305 HUMAN PRESCRIPTION DRUG Mushroom Mushroom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CULTIVATED MUSHROOM .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 49288-0306_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0306 HUMAN PRESCRIPTION DRUG Mustard Seed Mustard Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MUSTARD SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 49288-0307_13c9eea1-38b5-472b-b735-a814ca886718 49288-0307 HUMAN PRESCRIPTION DRUG Coastal Maple Coastal Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER MACROPHYLLUM POLLEN .05 g/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49288-0308_13c9eea1-38b5-472b-b735-a814ca886718 49288-0308 HUMAN PRESCRIPTION DRUG Maple Pollen Mixture Maple Pollen Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0309_13c9eea1-38b5-472b-b735-a814ca886718 49288-0309 HUMAN PRESCRIPTION DRUG Maple Pollen Mixture Maple Pollen Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN .0067; .0067; .0067 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0310_13c9eea1-38b5-472b-b735-a814ca886718 49288-0310 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PROSOPIS JULIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0311_13c9eea1-38b5-472b-b735-a814ca886718 49288-0311 HUMAN PRESCRIPTION DRUG Mulberry Mixture Mulberry Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0312_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0312 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CANDIDA ALBICANS .1 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 49288-0313_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0313 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CANDIDA ALBICANS .05 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 49288-0314_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0314 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CANDIDA ALBICANS .02 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 49288-0315_89b69938-05fc-4bd8-9c55-4fb46e9018c7 49288-0315 HUMAN PRESCRIPTION DRUG Mattress Dust Mattress Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HOUSE DUST .05 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 49288-0316_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0316 HUMAN PRESCRIPTION DRUG Mustard Greens Mustard Greens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MUSTARD GREENS .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0317_13c9eea1-38b5-472b-b735-a814ca886718 49288-0317 HUMAN PRESCRIPTION DRUG Melaleuca Melaleuca INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0318_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0318 HUMAN PRESCRIPTION DRUG Mucor racemosus Mucor racemosus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. MUCOR RACEMOSUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0319_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0319 HUMAN PRESCRIPTION DRUG Mucor racemosus Mucor racemosus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MUCOR RACEMOSUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0320_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0320 HUMAN PRESCRIPTION DRUG Candida tropicalis Candida tropicalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CANDIDA TROPICALIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0321_13c9eea1-38b5-472b-b735-a814ca886718 49288-0321 HUMAN PRESCRIPTION DRUG Hard (Sugar) Maple Hard (Sugar) Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER SACCHARUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0322_13c9eea1-38b5-472b-b735-a814ca886718 49288-0322 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER RUBRUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0323_13c9eea1-38b5-472b-b735-a814ca886718 49288-0323 HUMAN PRESCRIPTION DRUG Soft (Silver) Maple Soft (Silver) Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER SACCHARINUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0324_13c9eea1-38b5-472b-b735-a814ca886718 49288-0324 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MORUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0325_13c9eea1-38b5-472b-b735-a814ca886718 49288-0325 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MORUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0326_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0326 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. NEUROSPORA INTERMEDIA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0327_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0327 HUMAN PRESCRIPTION DRUG Nigrospora Nigrospora INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. KHUSKIA ORYZAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0328_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0328 HUMAN PRESCRIPTION DRUG Nigrospora Nigrospora INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. KHUSKIA ORYZAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0329_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0329 HUMAN PRESCRIPTION DRUG Nutmeg Nutmeg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. NUTMEG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 49288-0330_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0330 HUMAN PRESCRIPTION DRUG Nettle Pollen Nettle Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. URTICA DIOICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0331_13c9eea1-38b5-472b-b735-a814ca886718 49288-0331 HUMAN PRESCRIPTION DRUG Oak Mixture Oak Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS ALBA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS MUEHLENBERGII POLLEN; QUERCUS PALUSTRIS POLLEN; QUERCUS RUBRA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA POLLEN; QUERCUS VIRGINIANA POLLEN .0063; .0063; .0063; .0063; .0063; .0063; .0063; .0063 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0332_13c9eea1-38b5-472b-b735-a814ca886718 49288-0332 HUMAN PRESCRIPTION DRUG Oak Mixture Oak Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS ALBA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS MUEHLENBERGII POLLEN; QUERCUS PALUSTRIS POLLEN; QUERCUS RUBRA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA POLLEN; QUERCUS VIRGINIANA POLLEN .0025; .0025; .0025; .0025; .0025; .0025; .0025; .0025 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0333_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0333 HUMAN PRESCRIPTION DRUG Orange Orange INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ORANGE 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0334_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0334 HUMAN PRESCRIPTION DRUG Whole Grain Oat Whole Grain Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. OAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 49288-0335_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0335 HUMAN PRESCRIPTION DRUG Onion Onion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ONION .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0336_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0336 NON-STANDARDIZED ALLERGENIC Oyster Oyster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. OYSTER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 49288-0337_13c9eea1-38b5-472b-b735-a814ca886718 49288-0337 HUMAN PRESCRIPTION DRUG California (Coastal) Live Oak California (Coastal) Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0339_13c9eea1-38b5-472b-b735-a814ca886718 49288-0339 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. OLEA EUROPAEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0340_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0340 HUMAN PRESCRIPTION DRUG Tall Oat Grass Tall Oat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ARRHENATHERUM ELATIUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0341_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0341 HUMAN PRESCRIPTION DRUG Standardized Orchard Grass Pollen Standardized Orchard Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102228 Antigen Laboratories, Inc. DACTYLIS GLOMERATA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0342_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0342 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO AVENAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0343_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0343 HUMAN PRESCRIPTION DRUG Orris Root Orris Root INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. IRIS GERMANICA VAR. FLORENTINA ROOT .1 g/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient] 49288-0344_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0344 HUMAN PRESCRIPTION DRUG Orris Root Orris Root INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. IRIS GERMANICA VAR. FLORENTINA ROOT .05 g/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient] 49288-0345_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0345 HUMAN PRESCRIPTION DRUG Olive Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GREEN OLIVE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0346_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0346 HUMAN PRESCRIPTION DRUG Cultivated Oat Pollen Cultivated Oat Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AVENA SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0347_13c9eea1-38b5-472b-b735-a814ca886718 49288-0347 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CITRUS SINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0348_13c9eea1-38b5-472b-b735-a814ca886718 49288-0348 HUMAN PRESCRIPTION DRUG Live Oak Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS VIRGINIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0349_13c9eea1-38b5-472b-b735-a814ca886718 49288-0349 HUMAN PRESCRIPTION DRUG Live Oak Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0350_13c9eea1-38b5-472b-b735-a814ca886718 49288-0350 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0351_13c9eea1-38b5-472b-b735-a814ca886718 49288-0351 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0352_13c9eea1-38b5-472b-b735-a814ca886718 49288-0352 HUMAN PRESCRIPTION DRUG Bur Oak Bur Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS MACROCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0353_13c9eea1-38b5-472b-b735-a814ca886718 49288-0353 HUMAN PRESCRIPTION DRUG Pin Oak Pin Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS PALUSTRIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0354_13c9eea1-38b5-472b-b735-a814ca886718 49288-0354 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0355_13c9eea1-38b5-472b-b735-a814ca886718 49288-0355 HUMAN PRESCRIPTION DRUG Garrys Oak Garrys Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS GARRYANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0356_13c9eea1-38b5-472b-b735-a814ca886718 49288-0356 HUMAN PRESCRIPTION DRUG Gambel Oak Gambel Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS GAMBELII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0357_13c9eea1-38b5-472b-b735-a814ca886718 49288-0357 HUMAN PRESCRIPTION DRUG Number Three Oak Mixture Number Three Oak Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19760712 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0358_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0358 HUMAN PRESCRIPTION DRUG Pigweed Mixture Pigweed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0359_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0359 HUMAN PRESCRIPTION DRUG Pigweed Mixture Pigweed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN .005; .005; .005; .005 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0360_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0360 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0361_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0361 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0362_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0362 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0363_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0363 HUMAN PRESCRIPTION DRUG Penicillium Mixture Penicillium Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM ROQUEFORTI .0167; .0167; .0167; .0167; .0167; .0167 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0364_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0364 HUMAN PRESCRIPTION DRUG Penicillium Mixture Penicillium Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM ROQUEFORTI .0083; .0083; .0083; .0083; .0083; .0083 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0365_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0365 HUMAN PRESCRIPTION DRUG Phoma Phoma INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PHOMA DESTRUCTIVA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0366_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0366 HUMAN PRESCRIPTION DRUG Phoma Phoma INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PHOMA DESTRUCTIVA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0367_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0367 HUMAN PRESCRIPTION DRUG Pullularia Pullularia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0368_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0368 HUMAN PRESCRIPTION DRUG Pullularia Pullularia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0369_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0369 HUMAN PRESCRIPTION DRUG Pullularia Pullularia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .025 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0370_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0370 HUMAN PRESCRIPTION DRUG Paecilomyces Paecilomyces INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PAECILOMYCES VARIOTII .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0371_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0371 HUMAN PRESCRIPTION DRUG Paecilomyces Paecilomyces INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PAECILOMYCES VARIOTII .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0372_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0372 HUMAN PRESCRIPTION DRUG Papularia Papularia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. APIOSPORA MONTAGNEI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0373_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0373 HUMAN PRESCRIPTION DRUG Phycomyces Phycomyces INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PHYCOMYCES BLAKESLEEANUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0374_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0374 HUMAN PRESCRIPTION DRUG Potato Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POTATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0375_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0375 HUMAN PRESCRIPTION DRUG Pork Pork INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PORK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 49288-0376_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0376 HUMAN PRESCRIPTION DRUG Paprika Paprika INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PAPRIKA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 49288-0377_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0377 HUMAN PRESCRIPTION DRUG Parsley Parsley INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PARSLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0378_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0378 HUMAN PRESCRIPTION DRUG Peach Peach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PEACH 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0379_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0379 HUMAN PRESCRIPTION DRUG Peanut Peanut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PEANUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 49288-0380_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0380 HUMAN PRESCRIPTION DRUG Green Pea Green Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PEA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0381_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0381 HUMAN PRESCRIPTION DRUG Black-eyed Pea Black-eyed Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BLACK-EYED PEA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 49288-0382_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0382 HUMAN PRESCRIPTION DRUG Pear Pear INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PEAR .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0383_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0383 HUMAN PRESCRIPTION DRUG Pecan Nut Meat Pecan Nut Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PECAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 49288-0384_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0384 HUMAN PRESCRIPTION DRUG Black Pepper Black Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BLACK PEPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0385_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0385 HUMAN PRESCRIPTION DRUG Red Pepper Red Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RED BELL PEPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0386_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0386 HUMAN PRESCRIPTION DRUG Green Bell Pepper Green Bell Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GREEN BELL PEPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0387_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0387 NON-STANDARDIZED ALLERGENIC Perch Perch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PERCH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 49288-0388_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0388 HUMAN PRESCRIPTION DRUG Sweet Potato Sweet Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SWEET POTATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0389_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0389 HUMAN PRESCRIPTION DRUG Pumpkin Pumpkin INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PUMPKIN 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0390_1d474d27-4ce9-4bf6-b468-4a92281edc72 49288-0390 HUMAN PRESCRIPTION DRUG Parakeet Feather Parakeet Feather INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MELOPSITTACUS UNDULATUS FEATHER .02 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0391_13c9eea1-38b5-472b-b735-a814ca886718 49288-0391 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CARYA ILLINOINENSIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0392_13c9eea1-38b5-472b-b735-a814ca886718 49288-0392 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARYA ILLINOINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0393_13c9eea1-38b5-472b-b735-a814ca886718 49288-0393 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARYA ILLINOINENSIS POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0396_13c9eea1-38b5-472b-b735-a814ca886718 49288-0396 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS PONDEROSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0397_13c9eea1-38b5-472b-b735-a814ca886718 49288-0397 HUMAN PRESCRIPTION DRUG Poplar Mixture Poplar Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POPULUS ALBA POLLEN; POPULUS NIGRA POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0398_13c9eea1-38b5-472b-b735-a814ca886718 49288-0398 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LIGUSTRUM VULGARE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0399_13c9eea1-38b5-472b-b735-a814ca886718 49288-0399 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LIGUSTRUM VULGARE POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0400_13c9eea1-38b5-472b-b735-a814ca886718 49288-0400 HUMAN PRESCRIPTION DRUG Pepper Tree Pepper Tree INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SCHINUS MOLLE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0401_13c9eea1-38b5-472b-b735-a814ca886718 49288-0401 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0402_13c9eea1-38b5-472b-b735-a814ca886718 49288-0402 HUMAN PRESCRIPTION DRUG Number Three Pine Mixture Number Three Pine Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS ECHINATA POLLEN; PINUS PONDEROSA POLLEN; PINUS TAEDA POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0403_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0403 HUMAN PRESCRIPTION DRUG Pyrethrum Pyrethrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PYRETHRUM CINERARIIFOLIUM .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 49288-0404_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0404 HUMAN PRESCRIPTION DRUG Pimento Pimento INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RED BELL PEPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0405_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0405 HUMAN PRESCRIPTION DRUG Pineapple Pineapple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINEAPPLE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0406_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0406 HUMAN PRESCRIPTION DRUG Plum Plum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PLUM 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0407_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0407 HUMAN PRESCRIPTION DRUG Plum Plum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PLUM .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0408_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0408 HUMAN PRESCRIPTION DRUG Rough (Redroot) Pigweed Rough (Redroot) Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0409_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0409 HUMAN PRESCRIPTION DRUG Rough (Redroot) Pigweed Rough (Redroot) Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0410_13c9eea1-38b5-472b-b735-a814ca886718 49288-0410 HUMAN PRESCRIPTION DRUG Eastern White Pine Eastern White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PINUS STROBUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0411_13c9eea1-38b5-472b-b735-a814ca886718 49288-0411 HUMAN PRESCRIPTION DRUG Eastern White Pine Eastern White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19790909 BLA BLA102223 Antigen Laboratories, Inc. PINUS STROBUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0412_13c9eea1-38b5-472b-b735-a814ca886718 49288-0412 HUMAN PRESCRIPTION DRUG Australian Pine Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0413_13c9eea1-38b5-472b-b735-a814ca886718 49288-0413 HUMAN PRESCRIPTION DRUG Australian Pine Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0414_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0414 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0415_13c9eea1-38b5-472b-b735-a814ca886718 49288-0415 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS ELLIOTTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0416_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0416 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0417_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0417 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0418_13c9eea1-38b5-472b-b735-a814ca886718 49288-0418 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POPULUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0419_13c9eea1-38b5-472b-b735-a814ca886718 49288-0419 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POPULUS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0420_13c9eea1-38b5-472b-b735-a814ca886718 49288-0420 HUMAN PRESCRIPTION DRUG Lodgepole Pine Lodgepole Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS CONTORTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0421_13c9eea1-38b5-472b-b735-a814ca886718 49288-0421 HUMAN PRESCRIPTION DRUG Scotch Pine Scotch Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS SYLVESTRIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0422_13c9eea1-38b5-472b-b735-a814ca886718 49288-0422 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS TAEDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0423_13c9eea1-38b5-472b-b735-a814ca886718 49288-0423 HUMAN PRESCRIPTION DRUG Pitch Pine Pitch Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS RIGIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0424_13c9eea1-38b5-472b-b735-a814ca886718 49288-0424 HUMAN PRESCRIPTION DRUG Shortleaf Pine Shortleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS ECHINATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0425_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0425 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. IVA AXILLARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0426_80e3a713-b3c2-4981-9f01-d987196bc528 49288-0426 HUMAN PRESCRIPTION DRUG Cayenne Pepper Cayenne Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CHILI PEPPER .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0427_13c9eea1-38b5-472b-b735-a814ca886718 49288-0427 HUMAN PRESCRIPTION DRUG Number Two Pine Mixture Number Two Pine Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102223 Antigen Laboratories, Inc. PINUS CONTORTA POLLEN; PINUS PONDEROSA POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0429_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0429 HUMAN PRESCRIPTION DRUG Bakers Yeast Bakers Yeast INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SACCHAROMYCES CEREVISIAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 49288-0430_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0430 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ELYMUS REPENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0431_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0431 HUMAN PRESCRIPTION DRUG Ragweed Mixture Ragweed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0432_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0432 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. SALSOLA KALI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0433_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0433 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SALSOLA KALI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0434_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0434 HUMAN PRESCRIPTION DRUG Rhizopus Rhizopus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. RHIZOPUS STOLONIFER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0435_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0435 HUMAN PRESCRIPTION DRUG Rhizopus Rhizopus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RHIZOPUS STOLONIFER .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0436_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0436 HUMAN PRESCRIPTION DRUG Rhodotorula Rhodotorula INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RHODOTORULA RUBRA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0437_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0437 HUMAN PRESCRIPTION DRUG Rabbit Meat Rabbit Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RABBIT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 49288-0438_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0438 HUMAN PRESCRIPTION DRUG Radish Radish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RAPHANUS SATIVUS .05 g/mL 49288-0439_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0439 HUMAN PRESCRIPTION DRUG Raspberry Raspberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RASPBERRY 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0440_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0440 HUMAN PRESCRIPTION DRUG Raspberry Raspberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RASPBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0441_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0441 HUMAN PRESCRIPTION DRUG Rice Rice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RICE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 49288-0442_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0442 HUMAN PRESCRIPTION DRUG Rye Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RYE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 49288-0443_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0443 HUMAN PRESCRIPTION DRUG Rabbit Hair Rabbit Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ORYCTOLAGUS CUNICULUS HAIR .1 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] 49288-0444_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0444 HUMAN PRESCRIPTION DRUG Rabbit Hair Rabbit Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ORYCTOLAGUS CUNICULUS HAIR .05 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] 49288-0445_bffa4c39-d658-4a1c-b00a-3f0c411fa524 49288-0445 HUMAN PRESCRIPTION DRUG Redwood Pollen Redwood Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SEQUOIA SEMPERVIRENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0446_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0446 HUMAN PRESCRIPTION DRUG Slender Ragweed Slender Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA CONFERTIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0447_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0447 HUMAN PRESCRIPTION DRUG Giant Ragweed Giant Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0448_3a632396-c97c-4b7f-8eef-8908cf591385 49288-0448 HUMAN PRESCRIPTION DRUG Standardized Short Ragweed Pollen Standardized Short Ragweed Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19830115 BLA BLA102232 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 100000 [AU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0449_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0449 HUMAN PRESCRIPTION DRUG Southern Ragweed Southern Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA BIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0450_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0450 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0451_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0451 HUMAN PRESCRIPTION DRUG Standardized Redtop Grass Pollen Standardized Redtop Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102229 Antigen Laboratories, Inc. AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0452_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0452 HUMAN PRESCRIPTION DRUG Standardized Perennial Rye Grass Pollen Standardized Perennial Rye Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102230 Antigen Laboratories, Inc. LOLIUM PERENNE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0453_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0453 HUMAN PRESCRIPTION DRUG Cultivated Rye Grass Cultivated Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SECALE CEREALE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0454_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0454 HUMAN PRESCRIPTION DRUG Short/Giant Ragweed Mixture Short/Giant Ragweed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0455_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0455 HUMAN PRESCRIPTION DRUG Desert Ragweed Desert Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA DUMOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0456_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0456 HUMAN PRESCRIPTION DRUG Short/Giant/Western Ragweed Mixture Short/Giant/Western Ragweed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0457_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0457 HUMAN PRESCRIPTION DRUG Sage Mixture Sage Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA LUDOVICIANA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0458_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0458 HUMAN PRESCRIPTION DRUG Sage Mixture Sage Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA LUDOVICIANA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN .005; .005; .005; .005 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0459_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0459 HUMAN PRESCRIPTION DRUG Sorrel Mixture Sorrel Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RUMEX ACETOSELLA POLLEN; RUMEX ALTISSIMUS POLLEN; RUMEX CRISPUS POLLEN; RUMEX OBTUSIFOLIUS POLLEN; RUMEX SALICIFOLIUS VAR. MEXICANUS POLLEN .01; .01; .01; .01; .01 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0460_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0460 HUMAN PRESCRIPTION DRUG Sorrel Mixture Sorrel Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RUMEX ACETOSELLA POLLEN; RUMEX ALTISSIMUS POLLEN; RUMEX CRISPUS POLLEN; RUMEX OBTUSIFOLIUS POLLEN; RUMEX SALICIFOLIUS VAR. MEXICANUS POLLEN .004; .004; .004; .004; .004 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0461_f1a31511-6642-4da5-82cf-67c9ca728bc6 49288-0461 HUMAN PRESCRIPTION DRUG Miller Moth Miller Moth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SITOTROGA CEREALELLA .05 g/mL 49288-0462_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0462 HUMAN PRESCRIPTION DRUG Saccharomyces Saccharomyces INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SACCHAROMYCES CEREVISIAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 49288-0463_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0463 HUMAN PRESCRIPTION DRUG Scopulariopsis Scopulariopsis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MICROASCUS BREVICAULIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0464_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0464 HUMAN PRESCRIPTION DRUG Spondylocladium Spondylocladium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. COLLETOTRICHUM COCCODES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0465_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0465 HUMAN PRESCRIPTION DRUG Spondylocladium Spondylocladium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COLLETOTRICHUM COCCODES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0466_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0466 HUMAN PRESCRIPTION DRUG Stemphylium Stemphylium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PLEOSPORA HERBARUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0467_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0467 HUMAN PRESCRIPTION DRUG Stemphylium Stemphylium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PLEOSPORA HERBARUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0468_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0468 HUMAN PRESCRIPTION DRUG Streptomyces Streptomyces INJECTION, SOLUTION INTRADERMAL; SUBCONJUNCTIVAL 19740323 BLA BLA102223 Antigen Laboratories, Inc. STREPTOMYCES GRISEUS .05 g/mL Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0469_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0469 HUMAN PRESCRIPTION DRUG Sporotrichum Sporotrichum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SPOROTRICHUM PRUINOSUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0470_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0470 HUMAN PRESCRIPTION DRUG Stachybotrys Stachybotrys INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. STACHYBOTRYS CHARTARUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0471_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0471 HUMAN PRESCRIPTION DRUG Stachybotrys Stachybotrys INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. STACHYBOTRYS CHARTARUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0472_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0472 HUMAN PRESCRIPTION DRUG Syncephalastrum Syncephalastrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SYNCEPHALASTRUM RACEMOSUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0473_38eb8027-2cc3-42f8-ad39-70588a8bd791 49288-0473 HUMAN PRESCRIPTION DRUG Sole Sole INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ENGLISH SOLE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 49288-0474_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0474 HUMAN PRESCRIPTION DRUG Safflower Seed Safflower Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SAFFLOWER .05 g/mL 49288-0475_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0475 HUMAN PRESCRIPTION DRUG Sesame Seed Sesame Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SESAME SEED .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 49288-0476_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0476 NON-STANDARDIZED ALLERGENIC Salmon Salmon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ATLANTIC SALMON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 49288-0477_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0477 NON-STANDARDIZED ALLERGENIC Sardine Sardine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EUROPEAN PILCHARD .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 49288-0478_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0478 NON-STANDARDIZED ALLERGENIC Shrimp Shrimp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SHRIMP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 49288-0479_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0479 HUMAN PRESCRIPTION DRUG Spinach Spinach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SPINACH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0480_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0480 HUMAN PRESCRIPTION DRUG Strawberry Strawberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. STRAWBERRY 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0481_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0481 HUMAN PRESCRIPTION DRUG Sugar Beet Sugar Beet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BEET .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0482_80e3a713-b3c2-4981-9f01-d987196bc528 49288-0482 HUMAN PRESCRIPTION DRUG Sugar Cane Sugar Cane INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SUGARCANE .05 g/mL 49288-0483_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0483 HUMAN PRESCRIPTION DRUG Sunflower Seed Sunflower Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SUNFLOWER SEED .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 49288-0484_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0484 HUMAN PRESCRIPTION DRUG Annual Saltbush Annual Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0485_13c9eea1-38b5-472b-b735-a814ca886718 49288-0485 HUMAN PRESCRIPTION DRUG American Sycamore American Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0486_13c9eea1-38b5-472b-b735-a814ca886718 49288-0486 HUMAN PRESCRIPTION DRUG American Sycamore American Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0487_13c9eea1-38b5-472b-b735-a814ca886718 49288-0487 HUMAN PRESCRIPTION DRUG California Sycamore California Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PLATANUS RACEMOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0488_13c9eea1-38b5-472b-b735-a814ca886718 49288-0488 HUMAN PRESCRIPTION DRUG Maple Leaf Sycamore Maple Leaf Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PLATANUS HYBRIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0489_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0489 HUMAN PRESCRIPTION DRUG Coastal Sage Coastal Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19770909 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0490_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0490 HUMAN PRESCRIPTION DRUG Sunflower Pollen Sunflower Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HELIANTHUS ANNUUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0491_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0491 HUMAN PRESCRIPTION DRUG Sudan Grass Sudan Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SORGHUM BICOLOR SSP. DRUMMONDII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0492_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0492 HUMAN PRESCRIPTION DRUG Standardized Sweet Vernal Grass Pollen Standardized Sweet Vernal Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA103624 Antigen Laboratories, Inc. ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0493_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0493 HUMAN PRESCRIPTION DRUG Sage Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SALVIA OFFICINALIS .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 49288-0494_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0494 HUMAN PRESCRIPTION DRUG Saltgrass Saltgrass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. DISTICHLIS SPICATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0495_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0495 HUMAN PRESCRIPTION DRUG Common Mugwort Sage Common Mugwort Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19770909 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0496_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0496 HUMAN PRESCRIPTION DRUG Desert Sage Desert Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0497_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0497 HUMAN PRESCRIPTION DRUG Desert Sage Desert Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19770909 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0498_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0498 HUMAN PRESCRIPTION DRUG Common Wormwood Sage Common Wormwood Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19770909 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0499_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0499 HUMAN PRESCRIPTION DRUG Western Mugwort Sage Western Mugwort Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19770909 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0560_13c9eea1-38b5-472b-b735-a814ca886718 49288-0560 HUMAN PRESCRIPTION DRUG Tree Mixture Tree Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AILANTHUS ALTISSIMA POLLEN; BETULA PAPYRIFERA POLLEN; CARPINUS CAROLINIANA POLLEN; CARYA ALBA POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; PICEA PUNGENS POLLEN; PINUS STROBUS POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] 49288-0561_13c9eea1-38b5-472b-b735-a814ca886718 49288-0561 HUMAN PRESCRIPTION DRUG Tree Mixture Tree Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AILANTHUS ALTISSIMA POLLEN; BETULA PAPYRIFERA POLLEN; CARPINUS CAROLINIANA POLLEN; CARYA ALBA POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; PICEA PUNGENS POLLEN; PINUS STROBUS POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] 49288-0562_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0562 HUMAN PRESCRIPTION DRUG Trichoderma Trichoderma INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. TRICHODERMA VIRIDE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0563_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0563 HUMAN PRESCRIPTION DRUG Trichoderma Trichoderma INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRICHODERMA VIRIDE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0564_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0564 HUMAN PRESCRIPTION DRUG Tetracoccosporium paxianum Tetracoccosporium paxianum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TETRACOCCOSPORIUM PAXIANUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0565_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0565 HUMAN PRESCRIPTION DRUG Tomato Tomato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TOMATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 49288-0566_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0566 HUMAN PRESCRIPTION DRUG Tapioca Tapioca INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. STARCH, TAPIOCA .05 g/mL 49288-0567_80e3a713-b3c2-4981-9f01-d987196bc528 49288-0567 HUMAN PRESCRIPTION DRUG Tea Tea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TEA LEAF .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 49288-0568_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0568 NON-STANDARDIZED ALLERGENIC Trout Trout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TROUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 49288-0569_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0569 NON-STANDARDIZED ALLERGENIC Tuna Tuna INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TUNA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 49288-0570_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0570 HUMAN PRESCRIPTION DRUG Turkey Turkey INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TURKEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 49288-0571_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0571 HUMAN PRESCRIPTION DRUG Turnip Turnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TURNIP .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 49288-0572_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0572 HUMAN PRESCRIPTION DRUG Thyme Thyme INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GARDEN THYME .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0573_13c9eea1-38b5-472b-b735-a814ca886718 49288-0573 HUMAN PRESCRIPTION DRUG Tamarack Tamarack INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LARIX OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0574_13c9eea1-38b5-472b-b735-a814ca886718 49288-0574 HUMAN PRESCRIPTION DRUG Tree of Heaven Tree of Heaven INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0575_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0575 HUMAN PRESCRIPTION DRUG Standardized Timothy Grass Pollen Standardized Timothy Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102231 Antigen Laboratories, Inc. PHLEUM PRATENSE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0576_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0576 HUMAN PRESCRIPTION DRUG Trichophyton Mixture Trichophyton Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES; TRICHOPHYTON RUBRUM .05; .05 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0577_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0577 HUMAN PRESCRIPTION DRUG Trichophyton Mixture Trichophyton Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES; TRICHOPHYTON RUBRUM .025; .025 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0578_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0578 HUMAN PRESCRIPTION DRUG Trichophyton Mixture Trichophyton Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES; TRICHOPHYTON RUBRUM .01; .01 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0579_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0579 HUMAN PRESCRIPTION DRUG Trichophyton rubrum Trichophyton rubrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. TRICHOPHYTON RUBRUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0580_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0580 HUMAN PRESCRIPTION DRUG Trichophyton rubrum Trichophyton rubrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRICHOPHYTON RUBRUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0581_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0581 HUMAN PRESCRIPTION DRUG Leaf Tobacco Leaf Tobacco INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. TOBACCO LEAF .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 49288-0582_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0582 HUMAN PRESCRIPTION DRUG Leaf Tobacco Leaf Tobacco INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TOBACCO LEAF .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 49288-0583_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0583 HUMAN PRESCRIPTION DRUG Leaf Tobacco Leaf Tobacco INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TOBACCO LEAF .02 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 49288-0584_13c9eea1-38b5-472b-b735-a814ca886718 49288-0584 HUMAN PRESCRIPTION DRUG Number Eleven Tree Mixture Number Eleven Tree Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER SACCHARUM POLLEN; BETULA NIGRA POLLEN; CARYA OVATA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS RUBRA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0585_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0585 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0586_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0586 HUMAN PRESCRIPTION DRUG Number Ten Mold Mixture Number Ten Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; FUSARIUM OXYSPORUM; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; RHIZOPUS STOLONIFER .01; .0025; .0025; .0025; .0025; .01; .01; .01; .01; .01; .0017; .0017; .0017; .0017; .0017; .0017; .01; .01 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0587_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0587 HUMAN PRESCRIPTION DRUG Number Ten Mold Mixture Number Ten Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; FUSARIUM OXYSPORUM; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; RHIZOPUS STOLONIFER .005; .0013; .0013; .0013; .0013; .005; .005; .005; .005; .005; .0008; .0008; .0008; .0008; .0008; .0008; .005; .005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0588_13c9eea1-38b5-472b-b735-a814ca886718 49288-0588 HUMAN PRESCRIPTION DRUG Washington/Oregon Coastal Tree Mixture Washington/Oregon Coastal Tree Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19960712 BLA BLA102223 Antigen Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; FRAXINUS LATIFOLIA POLLEN; JUGLANS NIGRA POLLEN; JUGLANS REGIA POLLEN; PINUS CONTORTA POLLEN; POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN; QUERCUS GARRYANA POLLEN; SALIX LUCIDA SSP. LASIANDRA POLLEN .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0589_13c9eea1-38b5-472b-b735-a814ca886718 49288-0589 HUMAN PRESCRIPTION DRUG Washington/Oregon Inland Tree Mixture Washington/Oregon Inland Tree Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19960712 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALNUS RHOMBIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; FRAXINUS LATIFOLIA POLLEN; PINUS CONTORTA POLLEN; PINUS PONDEROSA POLLEN; POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN; POPULUS TREMULOIDES POLLEN; SALIX LUCIDA SSP. LASIANDRA POLLEN .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0590_13c9eea1-38b5-472b-b735-a814ca886718 49288-0590 HUMAN PRESCRIPTION DRUG Number Seven Tree Mixture Number Seven Tree Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102223 Antigen Laboratories, Inc. ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; BETULA NIGRA POLLEN; CARYA ILLINOINENSIS POLLEN; JUNIPERUS VIRGINIANA; POPULUS ALBA POLLEN; QUERCUS VIRGINIANA POLLEN; ULMUS AMERICANA POLLEN .0024; .0024; .0024; .0071; .0071; .0071; .0071; .0071; .0071 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0591_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0591 HUMAN PRESCRIPTION DRUG Vanilla Bean Vanilla Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. VANILLA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0592_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0592 HUMAN PRESCRIPTION DRUG Venison Venison INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. VENISON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 49288-0593_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0593 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HOLCUS LANATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0594_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0594 HUMAN PRESCRIPTION DRUG Verticillium Verticillium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. VERTICILLIUM ALBO-ATRUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0595_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0595 HUMAN PRESCRIPTION DRUG Whole Wheat Whole Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. WHEAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 49288-0596_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0596 HUMAN PRESCRIPTION DRUG English Walnut Meat English Walnut Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ENGLISH WALNUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 49288-0597_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0597 HUMAN PRESCRIPTION DRUG Black Walnut Meat Black Walnut Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BLACK WALNUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 49288-0598_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0598 HUMAN PRESCRIPTION DRUG Watermelon Watermelon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. WATERMELON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 49288-0599_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0599 NON-STANDARDIZED ALLERGENIC White Fish White Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. WHITEFISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 49288-0600_13c9eea1-38b5-472b-b735-a814ca886718 49288-0600 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUGLANS NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0601_13c9eea1-38b5-472b-b735-a814ca886718 49288-0601 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0602_13c9eea1-38b5-472b-b735-a814ca886718 49288-0602 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUGLANS NIGRA POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0603_13c9eea1-38b5-472b-b735-a814ca886718 49288-0603 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUGLANS CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0605_13c9eea1-38b5-472b-b735-a814ca886718 49288-0605 HUMAN PRESCRIPTION DRUG English Walnut Pollen English Walnut Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUGLANS REGIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0606_13c9eea1-38b5-472b-b735-a814ca886718 49288-0606 HUMAN PRESCRIPTION DRUG Western Black Willow Western Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SALIX LUCIDA SSP. LASIANDRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0607_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0607 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970909 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO TRITICI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0608_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0608 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRITICUM AESTIVUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0609_13c9eea1-38b5-472b-b735-a814ca886718 49288-0609 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19770909 BLA BLA102223 Antigen Laboratories, Inc. SALIX DISCOLOR POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0610_13c9eea1-38b5-472b-b735-a814ca886718 49288-0610 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SALIX NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0611_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0611 HUMAN PRESCRIPTION DRUG Number Two Weed Mixture Number Two Weed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; CHENOPODIUM ALBUM POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; XANTHIUM STRUMARIUM POLLEN .01; .01; .01; .01; .01 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0612_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0612 HUMAN PRESCRIPTION DRUG Number Four Weed Mixture Number Four Weed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; ARTEMISIA CALIFORNICA POLLEN; ARTEMISIA DRACUNCULUS POLLEN; ARTEMISIA FRIGIDA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN; CHENOPODIUM ALBUM POLLEN; IVA AXILLARIS POLLEN; KOCHIA SCOPARIA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALSOLA KALI POLLEN; XANTHIUM STRUMARIUM POLLEN .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0613_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0613 HUMAN PRESCRIPTION DRUG Western Wheatgrass Western Wheatgrass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PASCOPYRUM SMITHII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0614_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0614 HUMAN PRESCRIPTION DRUG Washington/Oregon Coastal Weed Mixture Washington/Oregon Coastal Weed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19960711 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; ARTEMISIA VULGARIS POLLEN; CHENOPODIUM ALBUM POLLEN; PLANTAGO LANCEOLATA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; XANTHIUM STRUMARIUM POLLEN .0071; .0071; .0071; .0071; .0071; .0071; .0071 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0615_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0615 HUMAN PRESCRIPTION DRUG Washington/Oregon Inland Weed Mixture Washington/Oregon Inland Weed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19960711 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN; ATRIPLEX CANESCENS POLLEN; CHENOPODIUM ALBUM POLLEN; IVA XANTHIFOLIA POLLEN; SALSOLA KALI POLLEN .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0616_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0616 HUMAN PRESCRIPTION DRUG Number Three Weed Mixture Number Three Weed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19960711 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; CHENOPODIUM ALBUM POLLEN; KOCHIA SCOPARIA POLLEN; RUMEX ACETOSELLA POLLEN .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 49288-0617_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0617 HUMAN PRESCRIPTION DRUG Brewers Yeast Brewers Yeast INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SACCHAROMYCES CEREVISIAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 49288-0618_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0618 HUMAN PRESCRIPTION DRUG Trichophyton schoenleinii Trichophyton schoenleinii INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRICHOPHYTON SCHOENLEINII .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0619_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0619 HUMAN PRESCRIPTION DRUG Absidia ramosa Absidia ramosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MYCOCLADUS CORYMBIFERUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0620_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0620 HUMAN PRESCRIPTION DRUG Acrothecium robustum Acrothecium robustum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACROTHECIUM ROBUSTUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0621_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0621 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS REPENS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0622_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0622 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0623_13c9eea1-38b5-472b-b735-a814ca886718 49288-0623 HUMAN PRESCRIPTION DRUG Green Ash Green Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS PENNSYLVANICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0624_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0624 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FLAVUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0625_13c9eea1-38b5-472b-b735-a814ca886718 49288-0625 HUMAN PRESCRIPTION DRUG Blue Beech (Hornbeam) Blue Beech (Hornbeam) INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARPINUS CAROLINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0626_13c9eea1-38b5-472b-b735-a814ca886718 49288-0626 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BETULA LENTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0627_13c9eea1-38b5-472b-b735-a814ca886718 49288-0627 HUMAN PRESCRIPTION DRUG Yellow Birch Yellow Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BETULA ALLEGHANIENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0628_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0628 HUMAN PRESCRIPTION DRUG Jerusalem Oak Jerusalem Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM BOTRYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0629_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0629 HUMAN PRESCRIPTION DRUG Tall Dock Tall Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RUMEX ALTISSIMUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0630_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0630 HUMAN PRESCRIPTION DRUG Bitter Dock Bitter Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RUMEX OBTUSIFOLIUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0631_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0631 HUMAN PRESCRIPTION DRUG White (Mexican) Dock White (Mexican) Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RUMEX SALICIFOLIUS VAR. MEXICANUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0633_13c9eea1-38b5-472b-b735-a814ca886718 49288-0633 HUMAN PRESCRIPTION DRUG Pignut Hickory Pignut Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARYA GLABRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0634_13c9eea1-38b5-472b-b735-a814ca886718 49288-0634 HUMAN PRESCRIPTION DRUG Bitternut Hickory Bitternut Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARYA CORDIFORMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0635_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0635 HUMAN PRESCRIPTION DRUG Humicola grisea Humicola grisea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HUMICOLA GRISEA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0636_13c9eea1-38b5-472b-b735-a814ca886718 49288-0636 HUMAN PRESCRIPTION DRUG Paper Mulberry Paper Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0637_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0637 HUMAN PRESCRIPTION DRUG Mucor mucedo Mucor mucedo INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RHIZOPUS STOLONIFER .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0638_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0638 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MUCOR PLUMBEUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0639_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0639 HUMAN PRESCRIPTION DRUG Neurospora crassa Neurospora crassa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. NEUROSPORA CRASSA .05 g/mL 49288-0640_13c9eea1-38b5-472b-b735-a814ca886718 49288-0640 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS VELUTINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0641_13c9eea1-38b5-472b-b735-a814ca886718 49288-0641 HUMAN PRESCRIPTION DRUG Chestnut Oak Chestnut Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS MUEHLENBERGII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0642_13c9eea1-38b5-472b-b735-a814ca886718 49288-0642 HUMAN PRESCRIPTION DRUG Post Oak Post Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS STELLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0643_bffa4c39-d658-4a1c-b00a-3f0c411fa524 49288-0643 HUMAN PRESCRIPTION DRUG Jack Pine Pollen Jack Pine Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS BANKSIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0644_13c9eea1-38b5-472b-b735-a814ca886718 49288-0644 HUMAN PRESCRIPTION DRUG Red Pine Red Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS RESINOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0645_13c9eea1-38b5-472b-b735-a814ca886718 49288-0645 HUMAN PRESCRIPTION DRUG Austrian Pine Austrian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0646_13c9eea1-38b5-472b-b735-a814ca886718 49288-0646 HUMAN PRESCRIPTION DRUG Japanese Black Pine Japanese Black Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS THUNBERGII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0647_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0647 HUMAN PRESCRIPTION DRUG Penicillium roquefortii Penicillium roquefortii INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM ROQUEFORTI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0648_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0648 HUMAN PRESCRIPTION DRUG Penicillium camembertii Penicillium camembertii INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM CAMEMBERTI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0649_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0649 HUMAN PRESCRIPTION DRUG Penicillium chrysogenum Penicillium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0650_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0650 HUMAN PRESCRIPTION DRUG Penicillium expansum Penicillium expansum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM EXPANSUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0651_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0651 HUMAN PRESCRIPTION DRUG Penicillium italicum Penicillium italicum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM ITALICUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0652_13c9eea1-38b5-472b-b735-a814ca886718 49288-0652 HUMAN PRESCRIPTION DRUG Blue Spruce Blue Spruce INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PICEA PUNGENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0653_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0653 HUMAN PRESCRIPTION DRUG Prairie Sage Prairie Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA FRIGIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0654_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0654 HUMAN PRESCRIPTION DRUG Indian Wormwood Sage Indian Wormwood Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA DRACUNCULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0655_fb54abb5-85cd-485f-9542-a2742a31bf72 49288-0655 HUMAN PRESCRIPTION DRUG Coca-Glycerine Control Coca-Glycerine Control INJECTION, SOLUTION INTRADERMAL 19740323 BLA BLA102223 Antigen Laboratories, Inc. GLYCERIN .525 mL/mL Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient] 49288-0656_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0656 HUMAN PRESCRIPTION DRUG Treatment Set TS329678 Treatment Set TS329678 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ALBA POLLEN; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN 10000; .005; 1000; 10000; .005; .005 [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0657_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0657 HUMAN PRESCRIPTION DRUG Treatment Set TS333938 Treatment Set TS333938 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARRHENATHERUM ELATIUS POLLEN; ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BETULA PAPYRIFERA POLLEN; BROMUS INERMIS POLLEN; BROMUS SECALINUS POLLEN; CARPINUS CAROLINIANA POLLEN; CARYA ALBA POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FUSARIUM OXYSPORUM; HOLCUS LANATUS POLLEN; IVA ANNUA VAR. ANNUA POLLEN; IVA XANTHIFOLIA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; MUCOR RACEMOSUS; PASCOPYRUM SMITHII POLLEN; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM ROQUEFORTI; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHOMA DESTRUCTIVA; PICEA PUNGENS POLLEN; PINUS STROBUS POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA COMPRESSA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; RHIZOPUS STOLONIFER; SALIX NIGRA POLLEN; SALSOLA KALI POLLEN; SECALE CEREALE POLLEN; SORGHUM BICOLOR SSP. DRUMMONDII POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; TYPHA LATIFOLIA POLLEN; ZEA MAYS POLLEN .00021; .00021; .00021; .00021; 454.5; .00021; .001; .00125; .00125; .00125; .00125; 454.5; .000227; .00025; .00025; .00025; .00025; .001; .00021; .000227; .000227; .00021; .00021; .00021; .00021; .001; .001; 45.5; 454.5; 1000; .000227; .00021; 454.5; .00021; .001; .000227; .0025; .0025; .00021; .00021; .00021; .00021; .00021; 454.5; .00021; .00021; .001; .000227; .00017; .00017; .00017; .00017; .00017; .00017; .000227; 454.5; .001; .00021; .00021; .005; .00021; .000227; 454.5; .00021; .001; .00021; .005; .000227; .000227; .000227; .000227; .000227; .000227 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0658_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0658 HUMAN PRESCRIPTION DRUG Treatment Set TS128872 Treatment Set TS128872 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARRHENATHERUM ELATIUS POLLEN; ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA LUDOVICIANA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN; BETULA PAPYRIFERA POLLEN; BROMUS INERMIS POLLEN; BROMUS SECALINUS POLLEN; CARPINUS CAROLINIANA POLLEN; CARYA ALBA POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; HOLCUS LANATUS POLLEN; IVA ANNUA VAR. ANNUA POLLEN; IVA XANTHIFOLIA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PICEA PUNGENS POLLEN; PINUS STROBUS POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA COMPRESSA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SECALE CEREALE POLLEN; SORGHUM BICOLOR SSP. DRUMMONDII POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; TYPHA LATIFOLIA POLLEN; ZEA MAYS POLLEN .00021; .00021; .00021; .00021; 454.5; .00021; .00125; .00125; .00125; .00125; .00125; .00125; .00125; .00125; 454.5; .000227; .00125; .00125; .00125; .00125; .00021; .000227; .000227; .00021; .00021; .00021; .00021; 1045.5; 454.5; .000227; .00021; 454.5; .00021; .000227; .0025; .0025; .00021; .00021; .00021; .00021; .005; .00021; 454.5; .00021; .00021; .000227; .000227; 454.5; .00021; .00021; .00021; .000227; 454.5; .00021; .0025; .0025; .00021; .000227; .000227; .000227; .000227; .000227; .000227 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] 49288-0659_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0659 HUMAN PRESCRIPTION DRUG Treatment Set TS128871 Treatment Set TS128871 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACREMONIUM STRICTUM; ACROTHECIUM ROBUSTUM; APIOSPORA MONTAGNEI; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SPICIFER; COLLETOTRICHUM COCCODES; FELIS CATUS HAIR; HUMICOLA GRISEA; HYPOMYCES PERNICIOSUS; KHUSKIA ORYZAE; MICROASCUS BREVICAULIS; MICROSPORUM AUDOUINII; MICROSPORUM CANIS; MYCOCLADUS CORYMBIFERUS; MYROTHECIUM VERRUCARIA; NEUROSPORA CRASSA; PAECILOMYCES VARIOTII; PASSALORA FULVA; PHYCOMYCES BLAKESLEEANUS; PLEOSPORA HERBARUM; SPORISORIUM CRUENTUM; SPOROTRICHUM PRUINOSUM; STACHYBOTRYS CHARTARUM; STREPTOMYCES GRISEUS; SYNCEPHALASTRUM RACEMOSUM; TETRACOCCOSPORIUM PAXIANUM; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII; TRICHOTHECIUM ROSEUM; USTILAGO CYNODONTIS; VERTICILLIUM ALBO-ATRUM .005; .00042; .00042; .005; .005; .00036; .00036; 500; .00042; .00036; .00036; .00036; .00042; .00042; .00042; .00036; .00036; .00036; .00036; .00042; .00036; .0025; .00042; .00042; .00036; .00042; .00042; .00036; .00036; .00036; .0025; .00042 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0660_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0660 HUMAN PRESCRIPTION DRUG Treatment Set TS128873 Treatment Set TS128873 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AILANTHUS ALTISSIMA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA PAPYRIFERA POLLEN; CARPINUS CAROLINIANA POLLEN; CARYA ALBA POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; CHENOPODIUM BOTRYS POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; IVA XANTHIFOLIA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; PICEA PUNGENS POLLEN; PINUS STROBUS POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SALSOLA KALI POLLEN .00021; .00021; .00021; .00021; .00021; .00125; .00125; .00125; .00125; .00125; .00125; .00125; .00125; .00021; .00021; .00021; .00021; .00021; .00167; .00167; .00167; .00021; .00021; .0025; .0025; .00021; .00021; .00021; .00021; .005; .00021; .00021; .00021; .00021; .00021; .005; .00021; .00021; .0025; .0025; .00021; .005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] 49288-0661_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0661 HUMAN PRESCRIPTION DRUG Treatment Set TS128870 Treatment Set TS128870 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; DERMATOPHAGOIDES PTERONYSSINUS; EQUUS CABALLUS HAIR; FELIS CATUS HAIR .005; 300; .005; 500 g/mL; [AU]/mL; g/mL; [BAU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] 49288-0662_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0662 HUMAN PRESCRIPTION DRUG Treatment Set TS330718 Treatment Set TS330718 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; MORUS ALBA POLLEN; MUCOR RACEMOSUS; PERIPLANETA AMERICANA; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .002; 800; .002; .00008; .002; 80; 80; 80; 16; .002; .002; .0004; .002; .002; 4000; .002; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0663_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0663 HUMAN PRESCRIPTION DRUG Treatment Set TS333400 Treatment Set TS333400 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR; PHLEUM PRATENSE POLLEN .01; .01; 2000; 20000 g/mL; g/mL; [BAU]/mL; [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0664_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0664 HUMAN PRESCRIPTION DRUG Treatment Set TS331884 Treatment Set TS331884 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; PERIPLANETA AMERICANA 2000; 2000; .01 [AU]/mL; [AU]/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0665_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0665 HUMAN PRESCRIPTION DRUG Treatment Set TS331413 Treatment Set TS331413 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; PHLEUM PRATENSE POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN 10000; .002; .002; 1000; .005; .005; 800; .005; .005 [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0666_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0666 HUMAN PRESCRIPTION DRUG Treatment Set TS333541 Treatment Set TS333541 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; FELIS CATUS HAIR; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS ASHEI POLLEN 20000; 2000; .01; .01 [AU]/mL; [BAU]/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0667_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0667 HUMAN PRESCRIPTION DRUG Treatment Set TS333312 Treatment Set TS333312 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091218 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN .01; .002; 80; .01; 800; .01 g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0668_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0668 HUMAN PRESCRIPTION DRUG Treatment Set TS332975 Treatment Set TS332975 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091218 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR .01; 400 g/mL; [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0669_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0669 HUMAN PRESCRIPTION DRUG Treatment Set TS333635 Treatment Set TS333635 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091218 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN .005; .005; 10000; .005; .005; .005; .005; .005; .002; .005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [Amb'a'1'U]/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0670_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0670 HUMAN PRESCRIPTION DRUG Treatment Set TS332406 Treatment Set TS332406 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091218 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; MORUS ALBA POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN .002; .002; 4000; .002; .002; 400; 400; .002; .002; .002; .002; .002; .002; 4000; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0671_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0671 HUMAN PRESCRIPTION DRUG Treatment Set TS332499 Treatment Set TS332499 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; ULMUS AMERICANA POLLEN .002; .002; 4000; .002; .002; 400; .002; .002; .002; 4000; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0672_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0672 HUMAN PRESCRIPTION DRUG Treatment Set TS332229 Treatment Set TS332229 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CLADOSPORIUM HERBARUM; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN .002; .0004; .002; 4000; .002; .002; .001; .001; .002; 400; 400; 400; .002; .002; .002; .002; .002; .002; 4000; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC] 49288-0673_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0673 HUMAN PRESCRIPTION DRUG Treatment Set TS332090 Treatment Set TS332090 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; IVA ANNUA VAR. ANNUA POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN .002; 4000; .002; .001; .001; 400; 400; 400; 400; .002; 4000; .002; .002; .002 g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0674_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0674 HUMAN PRESCRIPTION DRUG Treatment Set TS332091 Treatment Set TS332091 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091221 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CLADOSPORIUM HERBARUM; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN .002; .002; 4000; .002; .0004; .001; .001; .002; 400; 400; 400; .002; .002; .002; .002; .002; 4000; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0675_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0675 HUMAN PRESCRIPTION DRUG Treatment Set TS128811 Treatment Set TS128811 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; LOLIUM PERENNE POLLEN; POA PRATENSIS POLLEN; ULMUS AMERICANA POLLEN .005; 1428.6; 1428.6; 1428.6; 1428.6; 1428.6; .0025; .0025; .005; .005; 1428.6; 1428.6; .005 g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0676_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0676 HUMAN PRESCRIPTION DRUG Treatment Set TS129085 Treatment Set TS129085 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER RUBRUM POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ALBA POLLEN; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; MORUS RUBRA POLLEN; MUCOR RACEMOSUS; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .0004; .0004; 800; .002; .002; 80; 120; 120; .002; .002; .0004; .0004; .002; 32; .0004; .0004; .0004; .00008; .0004; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] 49288-0677_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0677 HUMAN PRESCRIPTION DRUG Treatment Set TS329595 Treatment Set TS329595 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR 800; .05 [AU]/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0678_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0678 HUMAN PRESCRIPTION DRUG Treatment Set TS129259 Treatment Set TS129259 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 400; 2000 [AU]/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0679_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0679 HUMAN PRESCRIPTION DRUG Treatment Set TS331657 Treatment Set TS331657 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALNUS RHOMBIFOLIA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; FELIS CATUS HAIR; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS ASHEI POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN .002; .002; 800; 4000; .002; .001; .001; 4000; 400; .002; .002; 4000; 4000; 4000; .002; .002 g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0680_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0680 HUMAN PRESCRIPTION DRUG Treatment Set TS333519 Treatment Set TS333519 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; LOLIUM PERENNE POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN 4000; 4000; 2000; 4000; 2000; 4000; 4000; .01 [AU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0681_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0681 HUMAN PRESCRIPTION DRUG Treatment Set TS333743 Treatment Set TS333743 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALNUS RHOMBIFOLIA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; BOS TAURUS HAIR; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; EPICOCCUM NIGRUM; FELIS CATUS HAIR; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; 4000; .002; .002; .002; .002; 400; 4000; 400; 400; .002; 400; 4000; 4000; 4000; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49288-0682_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0682 HUMAN PRESCRIPTION DRUG Treatment Set TS329802 Treatment Set TS329802 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; EPICOCCUM NIGRUM; JUNIPERUS ASHEI POLLEN; LOLIUM PERENNE POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .002; 4000; 4000; .002; .001; .001; .002; 400; 4000; 400; .002; .002; 4000; .002; 4000; .002; 4000; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49288-0683_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0683 HUMAN PRESCRIPTION DRUG Treatment Set TS330316 Treatment Set TS330316 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. BOS TAURUS HAIR; CANIS LUPUS FAMILIARIS HAIR; CAPRA HIRCUS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; MUCOR RACEMOSUS; PERIPLANETA AMERICANA; SUS SCROFA HAIR .002; .002; .002; 400; 400; 400; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0684_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0684 HUMAN PRESCRIPTION DRUG Treatment Set TS330317 Treatment Set TS330317 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALNUS RHOMBIFOLIA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .002; .002; 4000; 4000; .001; .001; .002; 400; .002; .002; .002; .002; 4000; .002; 4000; .002; .002; .002; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0685_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0685 HUMAN PRESCRIPTION DRUG Treatment Set TS333001 Treatment Set TS333001 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CELTIS OCCIDENTALIS POLLEN; FELIS CATUS HAIR; JUGLANS CALIFORNICA POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; URTICA DIOICA POLLEN .002; 4000; .002; .002; .002; 400; .002; 4000; .002; .002; .002; .002; .002; .002 g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0686_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0686 HUMAN PRESCRIPTION DRUG Treatment Set TS331802 Treatment Set TS331802 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN .005; 10000; .005; .005; .005; .005; .005 g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0687_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0687 HUMAN PRESCRIPTION DRUG Treatment Set TS330170 Treatment Set TS330170 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; BOS TAURUS HAIR; CANIS LUPUS FAMILIARIS HAIR; CAPRA HIRCUS HAIR; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS ASHEI POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; SORGHUM HALEPENSE POLLEN; SUS SCROFA HAIR 4000; 800; .002; .002; .002; 400; 400; .002; .002; 800; 800; .0002; .002; .002 [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0688_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0688 HUMAN PRESCRIPTION DRUG Treatment Set TS329123 Treatment Set TS329123 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MUCOR RACEMOSUS; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .002; 4000; 4000; .001; .001; .002; 400; .002; .002; .002; .002; 4000; .002; .002; .002; 4000; .002; .002; .002; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 49288-0689_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0689 HUMAN PRESCRIPTION DRUG Treatment Set TS331579 Treatment Set TS331579 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR .01; .002; 400 g/mL; g/mL; [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0690_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0690 HUMAN PRESCRIPTION DRUG Treatment Set TS329894 Treatment Set TS329894 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN .00017; 16666; 833.33; 1.33; .0083; .0083; .0083 g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0691_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0691 HUMAN PRESCRIPTION DRUG Treatment Set TS333308 Treatment Set TS333308 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER RUBRUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ALBA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; MORUS ALBA POLLEN; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .0004; 800; .0004; .002; 80; 80; 80; 80; .002; 160; .0004; .0004; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0692_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0692 HUMAN PRESCRIPTION DRUG Treatment Set TS332780 Treatment Set TS332780 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN .0002; 160; 3.2; 3.2; 16; .0002; 6.4; .0002; .0002; .0002; .000016 g/mL; [AU]/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 49288-0693_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0693 HUMAN PRESCRIPTION DRUG Treatment Set TS329905 Treatment Set TS329905 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .0017; .0017; .00056; .00056; .00056; .0003; .00083; .00083; .0017; 66.67; .0017; .0017; .0017; .0017; .0017; 666.67; .0003; .0017; .0017; .0017; .0003; .0017 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] 49288-0694_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0694 HUMAN PRESCRIPTION DRUG Treatment Set TS329906 Treatment Set TS329906 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00083; .00028; .00028; .00017; .00083; .00083; .00083; .00083; .00083; 166.67; 166.67; 166.67; .00083; .00028; .00083; .00083; .00083; .00083; .00083; .00042; .00021; .00042; .00021; .00021; .00021 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49288-0695_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0695 HUMAN PRESCRIPTION DRUG Treatment Set TS332509 Treatment Set TS332509 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; BETULA NIGRA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; GALLUS GALLUS FEATHER; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN .000668; .000668; .002; 400; 16; 16; 400; .002; .000668; 4000; .002; .002; .002 g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0696_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0696 HUMAN PRESCRIPTION DRUG Treatment Set TS330370 Treatment Set TS330370 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; RHIZOPUS STOLONIFER; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00017; .00028; .00028; .0008; .0008; .0008; .0008; .0008; .0008; 333.33; 333.33; 333.33; 33.33; .0008; .00028; .0008; .0008; .0008; .0008; 3333.33; .0008; .0017; .00042; .00021; .00042; .00021; .00021; .00021 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] 49288-0697_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0697 HUMAN PRESCRIPTION DRUG Treatment Set TS330359 Treatment Set TS330359 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN .0017; .0017; .00011; .00011; .00011; .0017; .00083; .00083; .0017; .0017; .0017; .0017; .0017; .0017; .0017; .0017; .0017; .0017; .0017 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0698_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0698 HUMAN PRESCRIPTION DRUG Treatment Set TS330454 Treatment Set TS330454 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; PERIPLANETA AMERICANA; PLANTAGO LANCEOLATA POLLEN; PLEOSPORA HERBARUM; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .000133; .00017; .0000044; .0000044; .0000044; .00083; .000133; .00017; .00017; .00033; 66.67; 33.33; 33.33; 33.33; .00033; .0042; .0017; .00017; .0083; .000133; .0021; .0021 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] 49288-0699_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0699 HUMAN PRESCRIPTION DRUG Treatment Set TS330583 Treatment Set TS330583 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; POA PRATENSIS POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN .001; .001; 400; 80; 80; 4000; .002; .00008 g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 49288-0700_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0700 HUMAN PRESCRIPTION DRUG Treatment Set TS331977 Treatment Set TS331977 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; PHLEUM PRATENSE POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN .0083; 133.33; .00083; .00083; .0083; .0017; .0017; .0017; 16666.67; .0083; .0017 g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0701_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0701 HUMAN PRESCRIPTION DRUG Treatment Set TS331955 Treatment Set TS331955 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN 2.67; 26.67; .0000133 [BAU]/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0702_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0702 HUMAN PRESCRIPTION DRUG Treatment Set TS332080 Treatment Set TS332080 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN .00033; 66.67; .00033; 666.67; .00033; .00033; .00033 g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0703_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0703 HUMAN PRESCRIPTION DRUG Treatment Set TS332594 Treatment Set TS332594 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .0000133; .0000133; .0000066; .0000066; .0000133; .0000066; .0000066; .0000133; 2.67; .0000133; .00033; .0000133; .0000133; .0000133; 26.67; .0000133; .0000133; .0000133; .0000133; .0000133; .0000133 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] 49288-0704_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0704 HUMAN PRESCRIPTION DRUG Treatment Set TS331046 Treatment Set TS331046 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CLADOSPORIUM HERBARUM; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN .0017; .00017; .0017; 133.33; .00083; .00083; .000165; .000165; .0000333; 333.33; 166.67; .00033; .0017; .0017; .0017; .0042; 666.67; .0017; .0017; .0017; .0017; .00033 g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49288-0705_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0705 HUMAN PRESCRIPTION DRUG Treatment Set TS330376 Treatment Set TS330376 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; RHIZOPUS STOLONIFER; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00083; .00033; .0000044; .0000044; .0000044; .00028; .00028; .00017; .00083; .00017; .00083; .00017; 66.67; 166.67; 166.67; 33.33; .00028; .00083; .00083; .00083; .00083; 133.33; .00033; .00083; .00033; .000415; .00021; .000415; .00021; .00021; .00021 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0706_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0706 HUMAN PRESCRIPTION DRUG Treatment Set TS333246 Treatment Set TS333246 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER RUBRUM POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; EPICOCCUM NIGRUM; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; MUCOR RACEMOSUS; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .004; .00008; .004; 800; .002; .002; .002; .002; .002; 80; 400; .002; 80; .002; .002; .002; .002; .004; 160; .002; .004; .002; .0004; .004 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE] 49288-0707_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0707 HUMAN PRESCRIPTION DRUG Treatment Set TS331810 Treatment Set TS331810 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; MORUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0083; .00085; .00085; .0083; .0017; .0083; .0083; .0017; .0083 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0708_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0708 HUMAN PRESCRIPTION DRUG Treatment Set TS331632 Treatment Set TS331632 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM HERBARUM; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS ASHEI POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHLEUM PRATENSE POLLEN .00017; .0083; 666.67; .00083; .00083; .00017; 333.33; 833.33; .0083; .0017; .000067; .00083; 3333.33 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0709_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0709 HUMAN PRESCRIPTION DRUG Treatment Set TS332626 Treatment Set TS332626 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; MORUS ALBA POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .00033; .0017; 133.33; .00083; .00085; .00085; 66.67; 166.67; 166.67; 33.33; .0017; .00033; .00033; .0017; .0083; .0042; 666.67; .00033; .0017; .00033; .00033; .00033; .00033; .0017 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0710_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0710 HUMAN PRESCRIPTION DRUG Treatment Set TS333315 Treatment Set TS333315 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; CANDIDA ALBICANS; CHENOPODIUM ALBUM POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; POA PRATENSIS POLLEN; SPORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; USTILAGO CYNODONTIS .0042; .00011; .00011; .00011; .0014; .0014; .0042; .0042; .00033; 833.33; 833.33; 833.33; .0014; 8333.33; .0021; .00033; .0021 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0711_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0711 HUMAN PRESCRIPTION DRUG Treatment Set TS330453 Treatment Set TS330453 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ASPERGILLUS FUMIGATUS; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; FUSARIUM OXYSPORUM; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .002; .00067; .00067; .00067; .002; .002; .002; .001; .001; .002; .002; .002; 400; .002; .002; .002; .002; .002; .002; 4000; .002; .002; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC] 49288-0712_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0712 HUMAN PRESCRIPTION DRUG Treatment Set TS329388 Treatment Set TS329388 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; IVA ANNUA VAR. ANNUA POLLEN; SORGHUM HALEPENSE POLLEN 333.33; 166.67; 166.67; 1.33; .0083; .0017 [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] 49288-0713_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0713 HUMAN PRESCRIPTION DRUG Treatment Set TS331327 Treatment Set TS331327 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; 400; .002; 160; .00008 g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0714_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0714 HUMAN PRESCRIPTION DRUG Treatment Set TS332256 Treatment Set TS332256 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .00167; .00167; 133.33; .000833; .000833; 333.33; .00033; .00033; .00167; .00833; 16666.67; .00167; .00167; .00167; .00167; .00167; .00167; .00833 g/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0715_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0715 HUMAN PRESCRIPTION DRUG Treatment Set TS331153 Treatment Set TS331153 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; .002; .001; .001; .002; 400; .002; .002; .002; 160; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0716_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0716 HUMAN PRESCRIPTION DRUG Treatment Set TS329151 Treatment Set TS329151 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00167; .0000133; .0000044; .0000044; .0000044; .00167; .00083; .00083; .0000133; 333.33; .00167; .00167; .00167; .00167; .00167; 3333.33; .0000133; .00167; .0000133; .000067; .0000133; .00167 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] 49288-0717_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0717 HUMAN PRESCRIPTION DRUG Treatment Set TS329152 Treatment Set TS329152 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .000833; .0002783; .002783; .000833; .000833; .000833; .000833; .000833; .000833; 166.67; 166.67; 166.67; .000833; .0002783; .000833; .000833; .000833; .000833; .000833; .0004167; .0002083; .0004167; .0002083; .0002083; .0002083 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0718_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0718 HUMAN PRESCRIPTION DRUG Treatment Set TS332147 Treatment Set TS332147 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; CANDIDA ALBICANS; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; KOCHIA SCOPARIA POLLEN; POA PRATENSIS POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN .0004; .0000267; .0000267; .0000267; .00067; .00067; .002; .002; .001; .001; 400; 400; .00067; .002; 800; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0719_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0719 HUMAN PRESCRIPTION DRUG Treatment Set TS330836 Treatment Set TS330836 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS AMERICANA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN .00033; 3333.33; .00033; .00033; .00167 g/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0720_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0720 HUMAN PRESCRIPTION DRUG Treatment Set TS331634 Treatment Set TS331634 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; IVA ANNUA VAR. ANNUA POLLEN; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; SORGHUM HALEPENSE POLLEN .0004; .002; 80; 2000; .01; .002; .002; .01 g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0721_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0721 HUMAN PRESCRIPTION DRUG Treatment Set TS330927 Treatment Set TS330927 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; GALLUS GALLUS FEATHER; PERIPLANETA AMERICANA; PLEOSPORA HERBARUM; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .002; .00067; .00067; .00008; .002; 400; 400; .00067; .002; .00008; .001; .00002; .001; .00002; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0722_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0722 HUMAN PRESCRIPTION DRUG Treatment Set TS330928 Treatment Set TS330928 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091218 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; .00067; .00067; .00067; .002; .001; .001; .002; 400; .00008; .00008; .002; .002; .002; .00008; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 49288-0723_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0723 HUMAN PRESCRIPTION DRUG Treatment Set TS331455 Treatment Set TS331455 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091218 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; BETULA NIGRA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; PERIPLANETA AMERICANA; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .002; .002; .00013; .00013; .00013; .00067; .00067; .002; .002; .002; .001; .001; .002; 80; 400; 400; 80; .00067; .002; .002; 800; .002; .002; .002; .002; .0004; .002; .0005; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE] 49288-0724_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0724 HUMAN PRESCRIPTION DRUG Treatment Set TS331621 Treatment Set TS331621 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091218 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RHIZOPUS STOLONIFER; SORGHUM HALEPENSE POLLEN; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .0004; .00004; .002; .00004; .00004; .0004; .0004; .002; 16; 80; 400; .002; .002; .00008; .002; .0004; .002; .002; 160; .0004; .002; .00004; .002; .0004; .0004; .0004; .0004 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC] 49288-0725_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0725 HUMAN PRESCRIPTION DRUG Treatment Set TS330171 Treatment Set TS330171 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091218 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; 160; .0004; 80; 800; 800; 800; .002; 800; .0004; .0004; .002 g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0726_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0726 HUMAN PRESCRIPTION DRUG Treatment Set TS329197 Treatment Set TS329197 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; KOCHIA SCOPARIA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .002; .00013; .00013; .00013; .002; .00004; .00004; .002; 16; .002; 4000; .002; .002; .002; .002; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0727_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0727 HUMAN PRESCRIPTION DRUG Treatment Set TS330416 Treatment Set TS330416 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYLON POLLEN; GALLUS GALLUS FEATHER; IVA ANNUA VAR. ANNUA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLANTAGO LANCEOLATA POLLEN; PLEOSPORA HERBARUM; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .002; .00008; .0000267; .0000267; .0000267; .00067; .00067; .002; .00008; .00008; .0004; .001; .001; .00008; .002; 400; .00067; .00008; .002; .002; .002; .00008; .00008; .00008; .002; .002; .002; .002; .001; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0728_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0728 HUMAN PRESCRIPTION DRUG Treatment Set TS329467 Treatment Set TS329467 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; FUSARIUM OXYSPORUM; IVA ANNUA VAR. ANNUA POLLEN; KOCHIA SCOPARIA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; RUMEX ACETOSELLA POLLEN; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .002; .002; .002; .002; .001; .001; .0004; .002; .002; .00008; .002; .002; .002; .002; .00008; .00008; .002; .001; .00002; .001; .00002; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE] 49288-0729_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0729 HUMAN PRESCRIPTION DRUG Treatment Set TS332343 Treatment Set TS332343 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00008; .00008; .0000267; .0000267; .0000267; .00008; .00004; .00004; .00008; 16; .00008; .00008; .00008; .00008; .002; 160; .00008; .00008; .00008; .00008; .00008; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] 49288-0730_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0730 HUMAN PRESCRIPTION DRUG Treatment Set TS332344 Treatment Set TS332344 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PLEOSPORA HERBARUM; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .002; .002; 400; 400; 16; .002; .00008; .00004; .00002; .00004; .00002; .00002; .00002 g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0731_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0731 HUMAN PRESCRIPTION DRUG Treatment Set TS329066 Treatment Set TS329066 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; GALLUS GALLUS FEATHER; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; RHIZOPUS STOLONIFER .002; .00013; .00013; .00013; .00067; .00067; .002; .002; .002; .002; 400; .002; .00067; .00008; .00008; .002; 4000; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0732_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0732 HUMAN PRESCRIPTION DRUG Treatment Set TS329915 Treatment Set TS329915 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CLADOSPORIUM CLADOSPORIOIDES; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; .002; .002; .002; 400; 400; 400; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0733_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0733 HUMAN PRESCRIPTION DRUG Treatment Set TS329109 Treatment Set TS329109 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN .01; .01; 800; 4000; 20000; 4000; .002; .01 g/mL; g/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0734_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0734 HUMAN PRESCRIPTION DRUG Treatment Set TS329161 Treatment Set TS329161 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .0004; .00008; .00008; .002; .00008; .00008; 16; 16; 16; .0004; .0004; .0004; .0004; .0004; .002; .001; .0005; .001; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49288-0735_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0735 HUMAN PRESCRIPTION DRUG Treatment Set TS329162 Treatment Set TS329162 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; .0000267; .0000267; .0000267; .002; .00004; .00004; .002; 16; .00008; .002; .0004; .00008; 160; .002; .002; .0004 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0736_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0736 HUMAN PRESCRIPTION DRUG Treatment Set TS331975 Treatment Set TS331975 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PERIPLANETA AMERICANA; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .000078; .0000267; .0000267; .0000267; .00008; .002; .002; .00004; .00004; .002; 16; 400; .00008; .00008; .002; .00008; .00008; 160; .00008; .00008; .002; .002; .002; .00002; .00002; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49288-0737_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0737 HUMAN PRESCRIPTION DRUG Treatment Set TS329526 Treatment Set TS329526 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; DERMATOPHAGOIDES FARINAE; PHLEUM PRATENSE POLLEN; QUERCUS ALBA POLLEN .002; 4000; 400; 4000; .0004 g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0738_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0738 HUMAN PRESCRIPTION DRUG Treatment Set TS330503 Treatment Set TS330503 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; JUNIPERUS VIRGINIANA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; USTILAGO CYNODONTIS .00008; .00067; .00067; .00067; .00067; .00067; .002; .002; .002; .002; .002; 16; 16; 400; .002; .00067; .002; .002; .002; .002; .00008; 160; .00008; .001; .002; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] 49288-0739_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0739 HUMAN PRESCRIPTION DRUG Treatment Set TS329750 Treatment Set TS329750 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PERIPLANETA AMERICANA; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .002; .002; .0000267; .0000267; .0000267; .00008; .0004; .001; .001; .002; 400; 16; 16; .002; .002; .002; .00008; .002; 160; .002; .002; .002; .002; .002; .001; .0005; .001; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49288-0740_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0740 HUMAN PRESCRIPTION DRUG Treatment Set TS331150 Treatment Set TS331150 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANIS LUPUS FAMILIARIS HAIR; CHENOPODIUM ALBUM POLLEN; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; POPULUS DELTOIDES POLLEN; RHIZOPUS STOLONIFER; SALSOLA KALI POLLEN; SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .00008; .002; .0000267; .0000267; .0000267; .002; .002; .002; .002; .002; 400; 400; 400; 16; .002; .0004; .00008; .002; .00008; .00008; .002; .002; .001; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0741_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0741 HUMAN PRESCRIPTION DRUG Treatment Set TS333176 Treatment Set TS333176 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER .002; .002; .002; .002; .002; 16; 16; .002; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0742_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0742 HUMAN PRESCRIPTION DRUG Treatment Set TS333177 Treatment Set TS333177 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN .00008; .002; .00067; .00067; .00067; .00008; .0002; .0002; .002; 16; .00008; .002; 4000; .00008; .0004; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 49288-0743_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0743 HUMAN PRESCRIPTION DRUG Treatment Set TS332486 Treatment Set TS332486 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN .00008; .00008; .00013; .00013; .00013; .0004; .0000267; .0000267; .002; 16; .002; .00008; .00008; .002; .00008; .00008; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0744_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0744 HUMAN PRESCRIPTION DRUG Treatment Set TS332487 Treatment Set TS332487 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .0000267; .0000267; .00008; .002; .002; .00008; .00008; 16; .00008; .0000267; .00008; .00008; .00008; .00008; .00008; .001; .0005; .001; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC] 49288-0745_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0745 HUMAN PRESCRIPTION DRUG Treatment Set TS329227 Treatment Set TS329227 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .002; .00013; .00013; .00013; .002; .001; .001; .002; 16; 400; .002; .002; .002; .002; 160; .002; .002; .002; .00008; .001; .002; .0005; .001; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] 49288-0746_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0746 HUMAN PRESCRIPTION DRUG Treatment Set TS330716 Treatment Set TS330716 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00008; .002; .0000267; .0000267; .0000267; .00008; .00004; .00004; .00008; 16; .00008; .0004; .00008; .0004; 160; .0004; .0004; .00008; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0747_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0747 HUMAN PRESCRIPTION DRUG Treatment Set TS330717 Treatment Set TS330717 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .00067; .00067; 10.00008; .002; .00008; .00008; .00008; .00008; 16; 16; .002; .00067; .00008; .002; .001; .00002; .001; .00002; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0748_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0748 HUMAN PRESCRIPTION DRUG Treatment Set TS332340 Treatment Set TS332340 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; GALLUS GALLUS FEATHER; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PERIPLANETA AMERICANA; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; RHIZOPUS STOLONIFER; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; USTILAGO CYNODONTIS .00008; .002; .0000267; .0000267; .0000267; .00067; .00067; .002; .0004; .00004; .00004; .002; 400; 16; 16; 80; .0004; .00067; .002; .00008; .002; .002; .002; 160; .002; .002; .002; .001; .0004; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE] 49288-0749_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0749 HUMAN PRESCRIPTION DRUG Treatment Set TS331258 Treatment Set TS331258 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .0004; .0000267; .0000267; .0000267; .00008; .00004; .00004; .00008; 16; .00008; .002; .00008; .00008; .00008; 160; .00008; .00008; .002; .002; .00008; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] 49288-0750_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0750 HUMAN PRESCRIPTION DRUG Treatment Set TS331259 Treatment Set TS331259 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PERIPLANETA AMERICANA; PLEOSPORA HERBARUM; SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .00008; .0000267; .0000267; .00008; .002; .002; 16; 16; .002; .0000267; .00008; .002; .001; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0751_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0751 HUMAN PRESCRIPTION DRUG Treatment Set TS331794 Treatment Set TS331794 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; CHENOPODIUM ALBUM POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .00008; .01; 400; .00008; .002; .01; .01; .01; .001; .001 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 49288-0752_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0752 HUMAN PRESCRIPTION DRUG Treatment Set TS330533 Treatment Set TS330533 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .002; .00067; .00067; .002; .002; .002; .00008; .00008; .00008; 16; 16; 16; .00008; .00067; .00008; .00008; .00008; .00008; .0004; .001; .0005; .001; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient] 49288-0753_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0753 HUMAN PRESCRIPTION DRUG Treatment Set TS330534 Treatment Set TS330534 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN .00008; .002; .002; .001; .001; .002; 400; .002; .00008; .00008; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0754_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0754 HUMAN PRESCRIPTION DRUG Treatment Set TS332850 Treatment Set TS332850 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FUMIGATUS; CLADOSPORIUM CLADOSPORIOIDES; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; RUMEX ACETOSELLA POLLEN .01; .01; 16; 16; 400; .002 g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0755_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0755 HUMAN PRESCRIPTION DRUG Treatment Set TS332131 Treatment Set TS332131 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; KOCHIA SCOPARIA POLLEN; PERIPLANETA AMERICANA; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN .0004; .0004; .00013; .00013; .00013; .00013; .00013; .0004; .0004; .0004; .0004; .0004; 80; 3.2; 3.2; 80; .00013; .0004; .0004; .0004; 32; .0004; .0004 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49288-0756_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0756 HUMAN PRESCRIPTION DRUG Treatment Set TS332507 Treatment Set TS332507 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN .00008; .01; .0000267; .0000267; .0000267; .00008; .00008; 160; .002; .00008; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0757_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0757 HUMAN PRESCRIPTION DRUG Treatment Set TS331567 Treatment Set TS331567 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; JUNIPERUS VIRGINIANA POLLEN; POA PRATENSIS POLLEN .005; .00013; .00013; .00013; .005; .0004; .0002; .0002; 1000; 16; 16; 400; .00008; 10000 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; [BAU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 49288-0758_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0758 HUMAN PRESCRIPTION DRUG Treatment Set TS331133 Treatment Set TS331133 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .0004; .0004; .00067; .00067; .00067; .0004; .0002; .0002; .002; 400; 400; 16; .00008; .0004; .0004; .00008; 800; .00008; .00008; .002; .0004; .0002; .0001; .0002; .0001; .0001; .0001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] 49288-0759_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0759 HUMAN PRESCRIPTION DRUG Treatment Set TS333374 Treatment Set TS333374 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN .00008; .00067; .00067; .00067; .002; .002; 16; .00008; .002; .00008; .00008; 4000; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0760_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0760 HUMAN PRESCRIPTION DRUG Treatment Set TS333373 Treatment Set TS333373 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .002; .00067; .00067; .00008; .002; .00008; .00008; .002; .002; 400; 16; 400; .00008; .00067; .002; .00008; .002; .00008; .00008; .00002; .00002; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0761_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0761 HUMAN PRESCRIPTION DRUG Treatment Set TS332287 Treatment Set TS332287 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00008; .00067; .00067; .00067; .0004; .001; .001; 16; .002; .002; .00008; 4000; .00008; .00008; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0762_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0762 HUMAN PRESCRIPTION DRUG Treatment Set TS332291 Treatment Set TS332291 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .0000267; .0000267; .00008; .0004; .002; .002; .00008; 400; 16; .00008; .0000267; .002; .002; .0004; .002; .00002; .00002; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0763_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0763 HUMAN PRESCRIPTION DRUG Treatment Set TS329240 Treatment Set TS329240 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; PLANTAGO LANCEOLATA POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00008; .002; .0000267; .0000267; .0000267; .00008; .002; .00004; .00004; .0004; 80; 400; .00008; .002; .00008; .002; .0004; .00008; .0004; .00008; 160; .00008; .00008; .0004; .002; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] 49288-0764_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0764 HUMAN PRESCRIPTION DRUG Treatment Set TS333375 Treatment Set TS333375 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00008; .00008; .0000267; .0000267; .0000267; .0004; .00004; .00004; .00008; 80; .00008; .00008; .00008; .002; .002; 160; .00008; .002; .00008; .002; .00008; .0004 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] 49288-0765_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0765 HUMAN PRESCRIPTION DRUG Treatment Set TS330821 Treatment Set TS330821 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PERIPLANETA AMERICANA; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; USTILAGO CYNODONTIS .002; .002; .0000267; .0000267; .0000267; .00067; .00067; .002; .00008; .002; 400; 16; 400; 16; .00067; .002; .00008; .002; .002; 160; .002; .001; .002; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE] 49288-0766_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0766 HUMAN PRESCRIPTION DRUG Treatment Set TS330156 Treatment Set TS330156 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; FUSARIUM OXYSPORUM; KOCHIA SCOPARIA POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .002; .002; .0000267; .0000267; .0000267; .002; .00008; .001; .001; .002; 16; 16; .002; .002; .002; .00008; 160; .002; .002; .00008; .001; .002; .0001; .001; .0001; .0001; .0001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49288-0767_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0767 HUMAN PRESCRIPTION DRUG Treatment Set TS332678 Treatment Set TS332678 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; CLADOSPORIUM CLADOSPORIOIDES; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .0004; .00067; .00067; .002; .002; 80; 80; 80; .00067; .002; .001; .001 g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0768_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0768 HUMAN PRESCRIPTION DRUG Treatment Set TS332679 Treatment Set TS332679 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00008; .0004; .0000267; .0000267; .0000267; .00008; .00004; .00004; .002; 16; .00008; .0004; .00008; .002; .00008; 160; .00008; .00008; .002; .002; .0004; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] 49288-0769_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0769 HUMAN PRESCRIPTION DRUG Treatment Set TS331795 Treatment Set TS331795 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00067; .00067; .002; .002; .002; .002; .002; 400; 16; .002; .00067; .002; .002; .002; .002; .002; .001; .0005; .001; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient] 49288-0770_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0770 HUMAN PRESCRIPTION DRUG Treatment Set TS331796 Treatment Set TS331796 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN .002; .00008; .002; .001; .001; .002; 400; .002; .0004; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 49288-0771_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0771 HUMAN PRESCRIPTION DRUG Treatment Set TS329413 Treatment Set TS329413 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CANDIDA ALBICANS; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; PERIPLANETA AMERICANA; SALSOLA KALI POLLEN .01; .01; 1000; 1000; .01; .01; .01; .01 g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 49288-0772_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0772 HUMAN PRESCRIPTION DRUG Treatment Set TS334128 Treatment Set TS334128 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .000027; .000027; .000027; .002; .00008; .002; .00004; .00004; .002; 16; .00008; .00008; .002; .002; .002; .002; 160; .00008; .00008; .002; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0773_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0773 HUMAN PRESCRIPTION DRUG Treatment Set TS334696 Treatment Set TS334696 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; MORUS ALBA POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0000666; .00033; 5.33; .0008333; .0000333; .0000333; 13.3333; 33.33; .0000133; .0000666; .0000666; .0000666; .00833; 666.67; .0000666; .0000666; .0000666; .0000666; .0000666; .0000666; .0003333 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] 49288-0774_93e07e85-ef26-4a23-a178-148bbd9369e2 49288-0774 HUMAN PRESCRIPTION DRUG Treatment Set TS334946 Treatment Set TS334946 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN .00008; .0004; .00002666; .00002666; .00002666; .00008; .00004; .00004; .0004; 16; .0004; .0004; .002; .002; .00008; 160; .002; .0004; .00008; .002; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE] 49288-0775_93e07e85-ef26-4a23-a178-148bbd9369e2 49288-0775 HUMAN PRESCRIPTION DRUG Treatment Set TS334947 Treatment Set TS334947 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER .00002666; .00002666; .00008; .00008; .0004; .0004; 16; .0004; .00002666; .0004; .00008; .0004; .002; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0776_620f9cd6-e5b8-4036-a2dd-388186abade3 49288-0776 HUMAN PRESCRIPTION DRUG Treatment Set TS334972 Treatment Set TS334972 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .000067; .0000133; .0000133; .000033; .000033; 13.33; .0000133; .00033; .000067; 26.67; .0000133; .0000133; .000067; .000067; .000067 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0777_769ae8c8-2f24-4e91-a9ae-4baf91c5a756 49288-0777 HUMAN PRESCRIPTION DRUG Treatment Set TS335100 Treatment Set TS335100 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .002; .000027; .000027; .002; .0004; .002; .002; .002; 16; 16; .002; .000027; .002; .0004; .002; .00008; .002; .00004; .0005; .00004; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0778_769ae8c8-2f24-4e91-a9ae-4baf91c5a756 49288-0778 HUMAN PRESCRIPTION DRUG Treatment Set TS335101 Treatment Set TS335101 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN .00008; .00008; .00008; .001; .001; .0004; 16; .002; .00008; .0004; .0004; .00008; .002; .002; .002; .0004; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0779_769ae8c8-2f24-4e91-a9ae-4baf91c5a756 49288-0779 HUMAN PRESCRIPTION DRUG Treatment Set TS335061 Treatment Set TS335061 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .002; .002; .001; .001; .002; 400; .002; .002; .002; 4000; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0780_52150fa7-4a21-4e92-8659-4277b21eff92 49288-0780 HUMAN PRESCRIPTION DRUG Treatment Set TS335657 Treatment Set TS335657 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; BETULA NIGRA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PERIPLANETA AMERICANA; PLEOSPORA HERBARUM; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .00008; .002; .00008; .0002; .0002; 400; 400; 16; .002; .002; .00008; .00008; .00008; .00008; .00008; .002; .00008; .00008; .00004; .00002; .00004; .00002; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0781_52150fa7-4a21-4e92-8659-4277b21eff92 49288-0781 HUMAN PRESCRIPTION DRUG Treatment Set TS335683 Treatment Set TS335683 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN 2000; 20000 [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0782_7653a564-fc76-4deb-bab0-0897c1851350 49288-0782 HUMAN PRESCRIPTION DRUG Treatment Set TS335823 Treatment Set TS335823 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; FRAXINUS AMERICANA POLLEN; GALLUS GALLUS FEATHER; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PERIPLANETA AMERICANA; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .00008; .002; .0000266; .0000266; .0000266; .0006666; .0006666; .00008; .00002; .00002; 400; 16; .00008; .0006666; .004; .00008; .00008; .0004; .00008; 160; .00008; .002; .00008; .00004; .0005; .00004; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0783_7653a564-fc76-4deb-bab0-0897c1851350 49288-0783 HUMAN PRESCRIPTION DRUG Treatment Set TS335861 Treatment Set TS335861 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; GALLUS GALLUS FEATHER; JUNIPERUS VIRGINIANA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PLANTAGO LANCEOLATA POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; RHIZOPUS STOLONIFER; ULMUS AMERICANA POLLEN .00008; .0000266; .0000266; .0000266; .0006666; .0006666; .00008; .0004; .002; 400; 80; 400; 16; .00008; .0006666; .0004; .002; .0004; .00008; .002; 160; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE] 49288-0784_84a6e36f-24af-40ed-8dd9-114b1108ccf3 49288-0784 HUMAN PRESCRIPTION DRUG Treatment Set TS336924 Treatment Set TS336924 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CLADOSPORIUM HERBARUM; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN .002; .002; 4000; .002; .002; .001; .001; .002; 400; 400; 400; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0785_84a6e36f-24af-40ed-8dd9-114b1108ccf3 49288-0785 HUMAN PRESCRIPTION DRUG Treatment Set TS336312 Treatment Set TS336312 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; GALLUS GALLUS FEATHER; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; QUERCUS ALBA POLLEN; RHIZOPUS STOLONIFER; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .002; .0004; .0006666; .0006666; .0006666; .000667; .000667; .002; .002; .00008; .001; .001; .00008; 400; .000667; .00008; .002; .00008; .00008; .002; .002; .002; .002; .00008; .00008; .0002; .0002; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] 49288-0786_51d18fca-e7c9-4032-8120-be71ed6e2a7f 49288-0786 HUMAN PRESCRIPTION DRUG Treatment Set TS336437 Treatment Set TS336437 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .0008; .002; .00008; .0000266; .0000266; .0000266; .00008; .00004; .00004; .00008; 16; 400; .00008; .00008; .00008; .00008; .00008; .00008; 160; .00008; .00008; .00008; .00008; .00008; .0002; .002; .00002; .0002; .00002; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient] 49288-0787_b4053499-e3af-4991-9c56-5eb96ac94dca 49288-0787 HUMAN PRESCRIPTION DRUG Treatment Set TS336667 Treatment Set TS336667 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR; PHLEUM PRATENSE POLLEN .002; 4000; .002; 400; 4000 g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] 49288-0788_b4053499-e3af-4991-9c56-5eb96ac94dca 49288-0788 HUMAN PRESCRIPTION DRUG Treatment Set TS336682 Treatment Set TS336682 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; LOLIUM PERENNE POLLEN; PASPALUM NOTATUM POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; RHIZOPUS STOLONIFER; SORGHUM HALEPENSE POLLEN .005; 80; 4000; 1000; 1000; 400; 160; .0004; 800; 800; .005; .0004 g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0789_b4053499-e3af-4991-9c56-5eb96ac94dca 49288-0789 HUMAN PRESCRIPTION DRUG Treatment Set TS336683 Treatment Set TS336683 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER RUBRUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN .0004; .0004; 20000; .000016; .000016; .002; .0004; .01; .00008; .0004; .00008; .0004; .002; .0004; .0004 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 49288-0790_2fc9a4e3-a3ca-4795-91c7-95f1061f4ae0 49288-0790 HUMAN PRESCRIPTION DRUG Treatment Set TS336851 Treatment Set TS336851 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM HERBARUM; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; IVA ANNUA VAR. ANNUA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; QUERCUS ALBA POLLEN; URTICA DIOICA POLLEN .002; .002; 4000; .002; .002; .002; 400; 400; 400; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0791_2fc9a4e3-a3ca-4795-91c7-95f1061f4ae0 49288-0791 HUMAN PRESCRIPTION DRUG Treatment Set TS337026 Treatment Set TS337026 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; DERMATOPHAGOIDES FARINAE; FRAXINUS AMERICANA POLLEN; GALLUS GALLUS FEATHER; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLEOSPORA HERBARUM; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .0004; .002; .00067; .00067; .00067; .00067; .00067; .00008; .002; .002; .00004; .00004; .002; 80; .00008; .00067; .002; .002; .002; .0004; .00008; .00008; .002; .002; .00002; .00002; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0792_d7b4b93b-b9fc-4188-a1ab-b905d286e2ee 49288-0792 HUMAN PRESCRIPTION DRUG Treatment Set TS337554 Treatment Set TS337554 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; QUERCUS ALBA POLLEN 2000; .01 [AU]/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0793_d7b4b93b-b9fc-4188-a1ab-b905d286e2ee 49288-0793 HUMAN PRESCRIPTION DRUG Treatment Set TS337681 Treatment Set TS337681 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CLADOSPORIUM HERBARUM; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0016666; .0008333; .0016666; 666.667; .0008333; .0000333; .0008333; .0008333; .0008333; 333.333; 166.667; 166.667; 33.333; .0003333; .0003333; .0016666; .0016666; 666.667; .0016666; .0016666; .0016666; .0016666; .0016666; .0016666; .0016666 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] 49288-0794_d7b4b93b-b9fc-4188-a1ab-b905d286e2ee 49288-0794 HUMAN PRESCRIPTION DRUG Treatment Set TS338384 Treatment Set TS338384 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; RHIZOPUS STOLONIFER .002; .005; .0006666; .0006666; .002; .005; .002; .002; .002; 400; 16; .005; .002; .0006666; .00008; .002; .005; 4000; .005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0795_dea14126-aacc-4f9f-81fe-9bf179310483 49288-0795 HUMAN PRESCRIPTION DRUG Treatment Set TS338618 Treatment Set TS338618 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; PHLEUM PRATENSE POLLEN 10000; 2000; 2000; .005; .05; 20000 [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0796_dea14126-aacc-4f9f-81fe-9bf179310483 49288-0796 HUMAN PRESCRIPTION DRUG Treatment Set TS338909 Treatment Set TS338909 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; DERMATOPHAGOIDES FARINAE; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .000016; .000016; .0000053; .0000053; .0000053; .000016; .000008; .000008; 3.2; .000016; .000016; .000016; .000016; 32; .000016; .000016; .000008; .000008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0797_dea14126-aacc-4f9f-81fe-9bf179310483 49288-0797 HUMAN PRESCRIPTION DRUG Treatment Set TS338910 Treatment Set TS338910 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; CYNODON DACTYLON POLLEN; GALLUS GALLUS FEATHER; IVA ANNUA VAR. ANNUA POLLEN; PERIPLANETA AMERICANA; SALSOLA KALI POLLEN; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .0004; .00013; .00013; 80; .00013; .00008; .00008; .0004; .0001; .0001; .0001; .0001 g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0798_dea14126-aacc-4f9f-81fe-9bf179310483 49288-0798 HUMAN PRESCRIPTION DRUG Treatment Set TS339118 Treatment Set TS339118 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .0000266; .00000266; .002; .01; .00008; .00008; .00008; 16; 16; .002; .0000266; .00008; .00008; .002; .0005; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0799_dea14126-aacc-4f9f-81fe-9bf179310483 49288-0799 HUMAN PRESCRIPTION DRUG Treatment Set TS339119 Treatment Set TS339119 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .0000266; .0000266; .0000266; .00008; .0004; .0004; .01; 80; .0004; .01; .002; .00008; .00008; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 49288-0800_546445e5-abf0-45e0-99fc-859dccb66062 49288-0800 HUMAN PRESCRIPTION DRUG Treatment Set TS339184 Treatment Set TS339184 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; FELIS CATUS HAIR; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .00008; .00008; .00008; .0004; .0004; 16; .0008; .00008; .00008; .00008; .00002; .00002; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0801_546445e5-abf0-45e0-99fc-859dccb66062 49288-0801 HUMAN PRESCRIPTION DRUG Treatment Set TS339185 Treatment Set TS339185 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00008; .00008; .00067; .00067; .00067; .00008; .00004; .00004; 400; .00008; .00008; .002; .0004; 160; .00008; .00008; .00008; .0004; .00008; .0004 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 49288-0802_604c0704-1a4c-431a-9876-de77f5f3882c 49288-0802 HUMAN PRESCRIPTION DRUG Treatment Set TS339754 Treatment Set TS339754 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; PASPALUM NOTATUM POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; SORGHUM HALEPENSE POLLEN 800; .002; .002; .002; 400; 16; 4000; .002; .002; 4000; .002; .002 [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0803_604c0704-1a4c-431a-9876-de77f5f3882c 49288-0803 HUMAN PRESCRIPTION DRUG Treatment Set TS339813 Treatment Set TS339813 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS ASHEI POLLEN .002; 4000; .002; 400; .002; .002 g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0804_604c0704-1a4c-431a-9876-de77f5f3882c 49288-0804 HUMAN PRESCRIPTION DRUG Treatment Set TS339992 Treatment Set TS339992 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS ASHEI POLLEN; PHLEUM PRATENSE POLLEN; ULMUS AMERICANA POLLEN .005; 10000; 1000; 400; 400; .005; .002; 4000; .005 g/mL; [AU]/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0805_604c0704-1a4c-431a-9876-de77f5f3882c 49288-0805 HUMAN PRESCRIPTION DRUG Treatment Set TS340053 Treatment Set TS340053 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .0006666; .0006666; .00008; .00008; .00008; .002; .002; .01; 16; 16; 16; .0006666; .002; .00008; .002; .002; .00008; .0002; .0005; .0002; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49288-0806_604c0704-1a4c-431a-9876-de77f5f3882c 49288-0806 HUMAN PRESCRIPTION DRUG Treatment Set TS340054 Treatment Set TS340054 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .002; .0000266; .0000266; .0000266; .002; .001; .001; .0004; 16; .002; .002; .00008; .00008; .00008; 160; .00008; .002; .0004; .00008; .0004 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] 49288-0807_ae8520ee-f4a4-4de4-9d2d-bccc97d30931 49288-0807 HUMAN PRESCRIPTION DRUG Treatment Set TS340074 Treatment Set TS340074 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; PHLEUM PRATENSE POLLEN; ULMUS AMERICANA POLLEN 10000; .002; .0025; .0025; 1000; 400; 400; 400; .005; .005; 4000; .005 [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0808_ae8520ee-f4a4-4de4-9d2d-bccc97d30931 49288-0808 HUMAN PRESCRIPTION DRUG Treatment Set TS340153 Treatment Set TS340153 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN .0002; .0002; .002; .01; .01; .01 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0809_ae8520ee-f4a4-4de4-9d2d-bccc97d30931 49288-0809 HUMAN PRESCRIPTION DRUG Treatment Set TS340525 Treatment Set TS340525 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .00067; .00067; .002; .002; .00008; .00008; .002; 16; 16; .00067; .00008; .00008; .00008; .00008; .00002; .00002; .00002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0810_ae8520ee-f4a4-4de4-9d2d-bccc97d30931 49288-0810 HUMAN PRESCRIPTION DRUG Treatment Set TS340526 Treatment Set TS340526 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN .00008; .002; .00008; .00008; .00008; .0004; .00004; .00004; .002; 16; .00008; .002; .002; .002; .002; 400; .00008; .0004; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0811_2413d900-60a6-4cfd-99b2-0ceccd0d1249 49288-0811 HUMAN PRESCRIPTION DRUG Treatment Set TS340796 Treatment Set TS340796 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; JUGLANS NIGRA POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN .002; .001; .001; 400; 400; 400; .002; .002; 4000 g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0812_2413d900-60a6-4cfd-99b2-0ceccd0d1249 49288-0812 HUMAN PRESCRIPTION DRUG Treatment Set TS340826 Treatment Set TS340826 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA ALLEGHANIENSIS POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA PAPYRIFERA POLLEN; BETULA POPULIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CHENOPODIUM ALBUM POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; HOUSE DUST; IVA ANNUA VAR. ANNUA POLLEN; IVA XANTHIFOLIA POLLEN; JUGLANS NIGRA POLLEN; KOCHIA SCOPARIA POLLEN; LOLIUM PERENNE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN .0008; .0008; .0008; .0024; .0012; .0012; .0004; .0004; .0004; .0004; .0004; .0004; .0024; .0024; 476.19; 4761.9; .0024; .0024; .0012; .0012; .0024; .0024; 4761.9; .0024; .0024; .0024; .0008; .0008; .0008; .0012; .0012; .0024; .0024 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] 49288-0813_059e23cb-ae1d-4fe5-9496-93f48225effd 49288-0813 HUMAN PRESCRIPTION DRUG Treatment Set TS340987 Treatment Set TS340987 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR .002 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0814_059e23cb-ae1d-4fe5-9496-93f48225effd 49288-0814 HUMAN PRESCRIPTION DRUG Treatment Set TS341430 Treatment Set TS341430 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BASSIA SCOPARIA POLLEN; CANDIDA ALBICANS; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CHENOPODIUM ALBUM POLLEN; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; IVA ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; POPULUS DELTOIDES POLLEN; RHIZOPUS STOLONIFER; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; USTILAGO CYNODONTIS .002; .002; .002; .002; .00008; .001; .001; .002; .002; .002; 16; 400; 16; .002; .00008; .0004; .002; .002; .002; .002; .002; .001; .00008; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0815_059e23cb-ae1d-4fe5-9496-93f48225effd 49288-0815 HUMAN PRESCRIPTION DRUG Treatment Set TS341451 Treatment Set TS341451 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; MORUS ALBA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SPORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .002; .002; 4000; .002; 80; 400; 400; .002; .002; .002; 32; .002; .002; .0004; .002; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0817_059e23cb-ae1d-4fe5-9496-93f48225effd 49288-0817 HUMAN PRESCRIPTION DRUG Treatment Set TS341474 Treatment Set TS341474 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; GALLUS GALLUS FEATHER; IVA ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RHIZOPUS STOLONIFER; SORGHUM HALEPENSE POLLEN; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .002; .002; .0000266; .0000266; .002; .002; .002; .00008; .002; .00004; .00004; .00008; 16; 400; .002; .0000266; .002; .00008; .00008; .002; .002; .002; .00008; .002; .002; .002; .0005; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] 49288-0818_059e23cb-ae1d-4fe5-9496-93f48225effd 49288-0818 HUMAN PRESCRIPTION DRUG Treatment Set TS341824 Treatment Set TS341824 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; BASSIA SCOPARIA POLLEN; BETULA ALLEGHANIENSIS POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA PAPYRIFERA POLLEN; BETULA POPULIFOLIA POLLEN; CHENOPODIUM ALBUM POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; LOLIUM PERENNE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00097; .00097; .00097; .0029; .00145; .00145; .0029; .00048; .00048; .00048; .00048; .00048; .00048; .0029; .00145; .0029; .00145; .0029; 5882; .0029; .0029; .0029; .00097; .00097; .00097; .0029; .0029; .0029 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0819_88d480d9-a016-4787-9db3-dcca62d0d1ca 49288-0819 NON-STANDARDIZED ALLERGENIC Treatment Set TS342034 Treatment Set TS342034 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR; PLANTAGO LANCEOLATA POLLEN .01; .01 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0820_88d480d9-a016-4787-9db3-dcca62d0d1ca 49288-0820 NON-STANDARDIZED ALLERGENIC Treatment Set TS342109 Treatment Set TS342109 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN .002; .002; .002; 4000; .002; .001; .001; 400; 400; .002; .002; .002; 4000; .002; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0821_88d480d9-a016-4787-9db3-dcca62d0d1ca 49288-0821 NON-STANDARDIZED ALLERGENIC Treatment Set TS342155 Treatment Set TS342155 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR; JUNIPERUS ASHEI POLLEN .01; 80; .01 g/mL; [BAU]/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0822_88d480d9-a016-4787-9db3-dcca62d0d1ca 49288-0822 NON-STANDARDIZED ALLERGENIC Treatment Set TS342370 Treatment Set TS342370 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN 2000; .01; .002 [BAU]/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0823_da61c6b6-9055-4d5e-909c-eeb1bf0e016c 49288-0823 HUMAN PRESCRIPTION DRUG Treatment Set TS342922 Treatment Set TS342922 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; CANDIDA ALBICANS; CLADOSPORIUM CLADOSPORIOIDES; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; GALLUS GALLUS FEATHER; JUNIPERUS VIRGINIANA POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; PLANTAGO LANCEOLATA POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RHIZOPUS STOLONIFER; ULMUS AMERICANA POLLEN; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .0006666; .0006666; .0006666; .000027; .000027; .002; .002; .00008; .002; 16; 400; 16; 16; .002; .000027; .00008; .00008; .002; .0004; .002; 4000; .00008; .002; .002; .002; .0005; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 49288-0824_bb49432e-682e-4b49-8a8e-a6f9eddd7bfc 49288-0824 HUMAN PRESCRIPTION DRUG Treatment Set TS343825 Treatment Set TS343825 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .01; .01; .01; .01; .01 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0825_bb49432e-682e-4b49-8a8e-a6f9eddd7bfc 49288-0825 HUMAN PRESCRIPTION DRUG Treatment Set TS343826 Treatment Set TS343826 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA VULGARIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; IVA AXILLARIS POLLEN; KOCHIA SCOPARIA POLLEN; LOLIUM PERENNE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .003; .0015; .0015; .003; .003; .003; .003; .003; 6666.67; .003; .003; .0015; .0015; .001; .001; .001; .003; .003; .003 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0826_bb49432e-682e-4b49-8a8e-a6f9eddd7bfc 49288-0826 HUMAN PRESCRIPTION DRUG Treatment Set TS344001 Treatment Set TS344001 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; SORGHUM HALEPENSE POLLEN .005; 800; .005; .005; 1000; 80; 400; 1000; 800; .002; 800; .0004; .005 g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0827_bb49432e-682e-4b49-8a8e-a6f9eddd7bfc 49288-0827 HUMAN PRESCRIPTION DRUG Treatment Set TS344002 Treatment Set TS344002 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .0004; 800; .0004; .0004; .0002; .0002; .0004; 80; 800; .0004; .0004; .0004; 800; .0004; .0004; .0004; .0004; .0004; .0004; .0004 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0828_bb49432e-682e-4b49-8a8e-a6f9eddd7bfc 49288-0828 HUMAN PRESCRIPTION DRUG Treatment Set TS344003 Treatment Set TS344003 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; PERIPLANETA AMERICANA .0004; .002; .002; .002; 400; 80; 400; .0004; .002 g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0829_bb49432e-682e-4b49-8a8e-a6f9eddd7bfc 49288-0829 HUMAN PRESCRIPTION DRUG Treatment Set TS344004 Treatment Set TS344004 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .002; 800; .002; .002; .0002; .0002; .002; 400; 4000; .002; .002; .002; 800; .002; .002; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0830_bb49432e-682e-4b49-8a8e-a6f9eddd7bfc 49288-0830 HUMAN PRESCRIPTION DRUG Treatment Set TS344005 Treatment Set TS344005 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; EQUUS CABALLUS HAIR; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; PERIPLANETA AMERICANA .002; .002; .002; .005; .005; 400; 400; .0004; 80; .005; .005 g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0831_f38e0c9c-da50-41d7-a0c6-506be87d4981 49288-0831 HUMAN PRESCRIPTION DRUG Treatment Set TS344059 Treatment Set TS344059 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; FELIS CATUS HAIR .01; 20000; .01; 2000 g/mL; [AU]/mL; g/mL; [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0832_f38e0c9c-da50-41d7-a0c6-506be87d4981 49288-0832 HUMAN PRESCRIPTION DRUG Treatment Set TS344419 Treatment Set TS344419 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .00008; .002; 160; .00008; .00008; .00004; .00004; .00008; 16; 160; .00008; .002; .00008; 160; .00008; .00008; .00008; .00008; .00008; .00008; .00008 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0833_f38e0c9c-da50-41d7-a0c6-506be87d4981 49288-0833 HUMAN PRESCRIPTION DRUG Treatment Set TS344420 Treatment Set TS344420 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; PERIPLANETA AMERICANA .00008; 400; 400; .002; .002 g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0834_f38e0c9c-da50-41d7-a0c6-506be87d4981 49288-0834 HUMAN PRESCRIPTION DRUG Treatment Set TS344421 Treatment Set TS344421 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; 160; .002; .01; .00004; .00004; .00008; 16; 400; .00008; .002; 400; .00008; .00008; .00008; .00008; .002; .00008; .00008 g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0835_f38e0c9c-da50-41d7-a0c6-506be87d4981 49288-0835 HUMAN PRESCRIPTION DRUG Treatment Set TS344422 Treatment Set TS344422 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; PERIPLANETA AMERICANA .002; .002; .002; 400; 400; 2000; .01 g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0836_3d2e8502-9a04-4060-a553-26e1bf285501 49288-0836 HUMAN PRESCRIPTION DRUG Treatment Set TS344558 Treatment Set TS344558 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; FRAXINUS AMERICANA POLLEN; FUSARIUM OXYSPORUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; QUERCUS ALBA POLLEN; RHIZOPUS STOLONIFER .00004; .005; .00008; .005; .005; .005; .002; .005; .005; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0837_3d2e8502-9a04-4060-a553-26e1bf285501 49288-0837 HUMAN PRESCRIPTION DRUG Treatment Set TS344570 Treatment Set TS344570 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; PASCOPYRUM SMITHII POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN .01; 4000; 400; 400; 400; .01; .01; .01; .002 g/mL; [AU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0838_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0838 HUMAN PRESCRIPTION DRUG Treatment Set TS344592 Treatment Set TS344592 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES PTERONYSSINUS .002; 2000 g/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0839_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0839 HUMAN PRESCRIPTION DRUG Treatment Set TS344801 Treatment Set TS344801 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; FELIS CATUS HAIR; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN .002; 4000; .002; .001; .001; 400; .002; .002 g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] 49288-0840_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0840 HUMAN PRESCRIPTION DRUG Treatment Set TS345048 Treatment Set TS345048 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR 20000; .01; 2000; 2000; 2000 [AU]/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0841_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0841 HUMAN PRESCRIPTION DRUG Treatment Set TS345049 Treatment Set TS345049 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00008; .00067; .00067; .00067; .001; .001; 16; .00008; .002; .002; 4000; .00008; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0842_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0842 HUMAN PRESCRIPTION DRUG Treatment Set TS345050 Treatment Set TS345050 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .002; .00003; .00003; .002; .002; .002; .00008; .00008; 400; .00003; .0008; .00008; .00008; .002; .002; .001; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0843_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0843 HUMAN PRESCRIPTION DRUG Treatment Set TS345268 Treatment Set TS345268 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN 20000; .01 [AU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0844_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0844 HUMAN PRESCRIPTION DRUG Treatment Set TS345302 Treatment Set TS345302 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00067; .00067; .00008; .0004; .0004; 400; 80; .00067; .0004; .002; .00008; .001; .0005; .001; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0845_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0845 HUMAN PRESCRIPTION DRUG Treatment Set TS345303 Treatment Set TS345303 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00008; .0004; .00013; .00013; .00013; .00008; .00004; .00004; .002; 16; .00008; .002; .0004; 160; .00008; .00008; .0004; .002; .00008; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0846_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0846 HUMAN PRESCRIPTION DRUG Treatment Set TS345380 Treatment Set TS345380 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS WHOLE; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; PASCOPYRUM SMITHII POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .002; 160; .01; .002; 400; .0004; .002; .002; .002; .002; .004; .0004; .0004 g/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0847_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0847 HUMAN PRESCRIPTION DRUG Treatment Set TS345381 Treatment Set TS345381 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM HERBARUM; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR .0004; .01; .0004; .0004; 16; 16; 80 g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0848_bfb6bdbb-da65-4cb3-a50d-250270cdd448 49288-0848 HUMAN PRESCRIPTION DRUG Treatment Set TS345463 Treatment Set TS345463 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; RUMEX ACETOSELLA POLLEN .002; 160; .002; .001; .001; 16; .0004; .002; 160; .0004 g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0849_bfb6bdbb-da65-4cb3-a50d-250270cdd448 49288-0849 HUMAN PRESCRIPTION DRUG Treatment Set TS345476 Treatment Set TS345476 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; ARTEMISIA ABSINTHIUM POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PLEOSPORA HERBARUM; RUMEX ACETOSELLA POLLEN .002; 4000; .005; .005; 1000; 1000; 400; .005; .005; .005 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 49288-0850_bfb6bdbb-da65-4cb3-a50d-250270cdd448 49288-0850 HUMAN PRESCRIPTION DRUG Treatment Set TS345694 Treatment Set TS345694 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; EQUUS CABALLUS HAIR; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; PHLEUM PRATENSE POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN .002; .002; 800; .002; .0002; .0002; 400; 80; 80; .00008; 80; 4000; .002; 4000; .002; .0004; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0851_bfb6bdbb-da65-4cb3-a50d-250270cdd448 49288-0851 HUMAN PRESCRIPTION DRUG Treatment Set TS345784 Treatment Set TS345784 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .0004; 800; .0004; .0002; .0002; 400; 400; 400; 800; .002; .00008; 160; .002 g/mL; [AU]/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0852_bfb6bdbb-da65-4cb3-a50d-250270cdd448 49288-0852 HUMAN PRESCRIPTION DRUG Treatment Set TS345825 Treatment Set TS345825 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; JUNIPERUS ASHEI POLLEN; MORUS ALBA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .0004; 160; .0004; 16; 400; .002; .0004; .0004; .0004; 160; .00008; .002; .0004; .00008; .0004; .002 g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0853_bfb6bdbb-da65-4cb3-a50d-250270cdd448 49288-0853 HUMAN PRESCRIPTION DRUG Treatment Set TS345883 Treatment Set TS345883 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CHENOPODIUM ALBUM POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; EQUUS CABALLUS HAIR; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; POPULUS DELTOIDES POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; URTICA DIOICA POLLEN .00008; .002; .002; 4000; .002; .00004; .00004; .0004; 16; .01; 400; .00008; .0004; .002; .0004; 800; .00008; .0004; .00008; .00008; .0004 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE] 49288-0854_bfb6bdbb-da65-4cb3-a50d-250270cdd448 49288-0854 HUMAN PRESCRIPTION DRUG Treatment Set TS346157 Treatment Set TS346157 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; IVA ANNUA POLLEN; PHLEUM PRATENSE POLLEN 4000; .005; 1000; 1000; 1000; .005; 4000 [AU]/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; [BAU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0855_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0855 NON-STANDARDIZED ALLERGENIC Treatment Set TS346618 Treatment Set TS346618 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; BETULA POPULIFOLIA POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .002; .002; 4000; .002; .002; 400; .002; .002; .002; .002; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0856_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0856 NON-STANDARDIZED ALLERGENIC Treatment Set TS346619 Treatment Set TS346619 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; SORGHUM HALEPENSE POLLEN .002; .00008; 160; .0004; .00004; .00004; 16; 800; .0004; .002; .0004; 160; .002; .00008 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0857_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0857 NON-STANDARDIZED ALLERGENIC Treatment Set TS346620 Treatment Set TS346620 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; PERIPLANETA AMERICANA .002; .002; .01; 80; 80; 80; .01 g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0858_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0858 NON-STANDARDIZED ALLERGENIC Treatment Set TS346697 Treatment Set TS346697 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PHLEUM PRATENSE POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .005; .005; .00008; .001; .001; 400; .0004; .002; .002; 10000; .005; .00008; .005; .005 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0859_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0859 NON-STANDARDIZED ALLERGENIC Treatment Set TS346698 Treatment Set TS346698 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PHLEUM PRATENSE POLLEN; POPULUS DELTOIDES POLLEN .002; 800; .00008; 4000; .002 g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0860_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0860 NON-STANDARDIZED ALLERGENIC Treatment Set TS346752 Treatment Set TS346752 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CHENOPODIUM ALBUM POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .002; .002; 4000; .002; .002; .00004; .00004; .002; .002; 400; .00008; .002; .0004; .002; 4000; .002; .002; .002; .00008; .002; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0861_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0861 NON-STANDARDIZED ALLERGENIC Treatment Set TS346790 Treatment Set TS346790 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; 4000; .002; .001; .001; 400; 160; .002; .0004; .00008; 160; .002; .002; .002; .002; .0004 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0862_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0862 NON-STANDARDIZED ALLERGENIC Treatment Set TS346791 Treatment Set TS346791 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; FELIS CATUS HAIR; PERIPLANETA AMERICANA .0004; .01; .01; 400; .01 g/mL; g/mL; g/mL; [BAU]/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0863_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0863 NON-STANDARDIZED ALLERGENIC Treatment Set TS346876 Treatment Set TS346876 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .00008; 160; .005; .00004; .0004; .00008; .00008; .005; .0004; .002; .0004; .001; .0004; .001; .002; .005; .002; .0004; .0004 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0864_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0864 NON-STANDARDIZED ALLERGENIC Treatment Set TS346877 Treatment Set TS346877 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FUSARIUM OXYSPORUM; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .005; .0004; .005; .005; 16; 16; 10000; .005; .0004; 160; .0004 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0865_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0865 NON-STANDARDIZED ALLERGENIC Treatment Set TS346889 Treatment Set TS346889 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; AVENA SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FUSARIUM OXYSPORUM; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; URTICA DIOICA POLLEN .002; .002; 4000; .002; .00008; .00004; .00004; 16; 400; 160; .002; .002; .002; .002; .0004; .002; 800; .002; .002; .002; .0004; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] 49288-0866_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0866 NON-STANDARDIZED ALLERGENIC Treatment Set TS346962 Treatment Set TS346962 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .0004; 160; .002; .00004; .00004; .002; .0004; .002; .002; .0004; .002; .00008; .001; .002; .001; .002; .0004; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0867_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0867 NON-STANDARDIZED ALLERGENIC Treatment Set TS346963 Treatment Set TS346963 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FUSARIUM OXYSPORUM; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; .002; .002; .002; .002; 16; 80; 400; 400; 4000; .002; .0004; .002; 800; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0868_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0868 NON-STANDARDIZED ALLERGENIC Treatment Set TS346964 Treatment Set TS346964 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; AVENA SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; URTICA DIOICA POLLEN .002; .002; 4000; .002; .00008; .0002; .0002; 400; 400; 4000; .002; .002; .0004; .0004; 4000; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0869_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0869 NON-STANDARDIZED ALLERGENIC Treatment Set TS347115 Treatment Set TS347115 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .00008; 4000; .002; .0004; .00004; .00004; .0004; 16; 4000; .00008; .0004; .00008; .002; 800; .002; .0004; .0002; .00008; .0002; .0004; .0004; .0004; .002; .00008; .0004 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0870_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0870 NON-STANDARDIZED ALLERGENIC Treatment Set TS347116 Treatment Set TS347116 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; MORUS RUBRA POLLEN .01; .002; .002; 400; 2000; 80; .0004 g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0871_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0871 NON-STANDARDIZED ALLERGENIC Treatment Set TS347226 Treatment Set TS347226 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AVENA SATIVA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; JUGLANS NIGRA POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; URTICA DIOICA POLLEN .002; .00008; .00067; .00004; .00004; .002; 80; 80; 160; .0004; .00067; .00067; .00008; 160; .002; .002; .001; .001; .002; .002; .00008; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] 49288-0872_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0872 NON-STANDARDIZED ALLERGENIC Treatment Set TS347227 Treatment Set TS347227 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; BETULA POPULIFOLIA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; POPULUS ALBA POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; SALIX NIGRA POLLEN; SORGHUM HALEPENSE POLLEN .0004; .002; .00013; .002; .00004; .00004; .002; 400; 400; 4000; .002; .002; .002; .00013; .00013; .002; 800; .001; .001; .0004; .002; .0004 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49288-0873_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0873 NON-STANDARDIZED ALLERGENIC Treatment Set TS347249 Treatment Set TS347249 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FUSARIUM OXYSPORUM; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; 4000; .002; .001; .001; .002; .002; 80; 400; 400; 400; 800; .002; .002; .0004; .002; 800; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0874_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0874 NON-STANDARDIZED ALLERGENIC Treatment Set TS347250 Treatment Set TS347250 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; QUERCUS ALBA POLLEN .0002; .0002; 20000; .0004; .01; 4000; .0004 g/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0875_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0875 NON-STANDARDIZED ALLERGENIC Treatment Set TS347335 Treatment Set TS347335 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; EQUUS CABALLUS HAIR; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .002; .00008; 1000; .002; 80; 4000; .005; .002; 4000; .002; .002; .005; .005 g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0876_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0876 NON-STANDARDIZED ALLERGENIC Treatment Set TS347336 Treatment Set TS347336 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .0004; 4000; .00004; .00004; .0004; .0004; .0004; .00008; .00008; .002; .0004; .00008; .00008; .0004; .002; .0004; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0877_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0877 NON-STANDARDIZED ALLERGENIC Treatment Set TS347337 Treatment Set TS347337 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; SORGHUM HALEPENSE POLLEN .002; .01; .002; 80; 2000; 20000; .002; .00008 g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0878_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0878 NON-STANDARDIZED ALLERGENIC Treatment Set TS347338 Treatment Set TS347338 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; SALIX NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .002; .002; 800; .002; .0002; .0002; .002; 400; 400; .0004; .002; .002; 800; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0879_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0879 NON-STANDARDIZED ALLERGENIC Treatment Set TS347483 Treatment Set TS347483 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; URTICA DIOICA POLLEN .002; 10000; .0004; .005; .001; .001; 400; 4000; .005; .002; .002; .005 g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0880_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0880 NON-STANDARDIZED ALLERGENIC Treatment Set TS347484 Treatment Set TS347484 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; ASPERGILLUS FUMIGATUS; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CLADOSPORIUM HERBARUM; DERMATOPHAGOIDES PTERONYSSINUS; EQUUS CABALLUS HAIR; FRAXINUS AMERICANA POLLEN; PLANTAGO LANCEOLATA POLLEN; URTICA DIOICA POLLEN .002; .005; .005; .001; .001; .005; 400; .002; .005; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0881_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0881 NON-STANDARDIZED ALLERGENIC Treatment Set TS347536 Treatment Set TS347536 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; ASPERGILLUS FUMIGATUS; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN .002; .002; .002; .002; .01; .001; .001; 2000; 4000; .01; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0882_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0882 NON-STANDARDIZED ALLERGENIC Treatment Set TS347537 Treatment Set TS347537 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AVENA SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .002; .0004; .002; .0002; .0002; .002; 400; .002; .002; .0004; .002; 4000; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0883_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0883 NON-STANDARDIZED ALLERGENIC Treatment Set TS347627 Treatment Set TS347627 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; BOS TAURUS HAIR; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES PTERONYSSINUS; EQUUS CABALLUS HAIR; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; ODOCOILEUS VIRGINIANUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; PERIPLANETA AMERICANA .002; .00067; .0067; .005; .002; .005; .002; 400; .00008; 400; .00067; .005; .005; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient] 49288-0884_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0884 NON-STANDARDIZED ALLERGENIC Treatment Set TS347628 Treatment Set TS347628 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .00008; .00008; .0002; .0002; .002; 16; 160; .00008; .002; .002; .002; .00008; 160; .002; .002; .004; .002; .004; .00008; 4000; .002; .0004; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] 49288-0885_e266b12c-c311-4e1b-9d5a-1f448a15eb0e 49288-0885 NON-STANDARDIZED ALLERGENIC Treamtent Set TS347738 Treamtent Set TS347738 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; URTICA DIOICA POLLEN .002; .002; 4000; .001; .001; .00008; 80; 400; .002; .002; .002; .002; 160; .002; .001; .002; .001; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0886_e266b12c-c311-4e1b-9d5a-1f448a15eb0e 49288-0886 NON-STANDARDIZED ALLERGENIC Treatment Set TS347745 Treatment Set TS347745 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; URTICA DIOICA POLLEN .002; .0004; 160; .002; .001; .001; .002; .002; .0004; .002; .002; .002; .002; .002; .0004; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0887_e266b12c-c311-4e1b-9d5a-1f448a15eb0e 49288-0887 NON-STANDARDIZED ALLERGENIC Treatment Set TS347746 Treatment Set TS347746 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FUSARIUM OXYSPORUM; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .0004; .002; .0004; .002; 16; 400; 800; .002; .0004; .002; 160; .002 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0888_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0888 NON-STANDARDIZED ALLERGENIC Treatment Set TS348237 Treatment Set TS348237 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN .005; 10000; .005; .002; 400; .005; 10000 g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0889_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0889 NON-STANDARDIZED ALLERGENIC Treatment Set TS348283 Treatment Set TS348283 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; 4000; .002; 400; 400; .002; .002; 4000; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0890_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0890 NON-STANDARDIZED ALLERGENIC Treatment Set TS348334 Treatment Set TS348334 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .002; 4000; .002; .002; .001; .001; .002; 80; 4000; .0004; .002; .002; .002; .002; 4000; .002; .002; .0004; .0004; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0891_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0891 NON-STANDARDIZED ALLERGENIC Treatment Set TS348335 Treatment Set TS348335 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; FUSARIUM OXYSPORUM; PERIPLANETA AMERICANA .002; .01; .01; .01; .01; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0892_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0892 NON-STANDARDIZED ALLERGENIC Treatment Set TS348402 Treatment Set TS348402 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .002; 4000; .0004; .0002; .0002; 400; 4000; .002; .002; .0004; .002; .002; 800; .0004; .002; .002; .002; .0004; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0893_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0893 NON-STANDARDIZED ALLERGENIC Treatment Set TS348403 Treatment Set TS348403 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; FELIS CATUS HAIR .002; .01; .002; 400 g/mL; g/mL; g/mL; [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0894_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0894 NON-STANDARDIZED ALLERGENIC Treatment Set TS348404 Treatment Set TS348404 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .00008; 4000; .002; .00004; .00004; .0004; .0004; .00008; .002; .002; .002; .0002; .002; .0002; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0895_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0895 NON-STANDARDIZED ALLERGENIC Treatment Set TS348405 Treatment Set TS348405 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AVENA SATIVA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .00008; .002; 80; 20000; .01; 20000; .0004 g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0896_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0896 NON-STANDARDIZED ALLERGENIC Treatment Set TS348467 Treatment Set TS348467 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; CARYA TOMENTOSA POLLEN; CLADOSPORIUM HERBARUM; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; JUNIPERUS ASHEI POLLEN; MORUS ALBA POLLEN; MUCOR RACEMOSUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .0004; .002; 160; .002; .0004; .002; 400; 400; .002; .002; .002; .002; .002; .002; .0004; 800; .002; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] 49288-0897_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0897 NON-STANDARDIZED ALLERGENIC Treatment Set TS348490 Treatment Set TS348490 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20121116 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .002; 800; .002; .00004; .00004; .002; .0004; .002; .002; .002; .002; .002; .001; .002; .001; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0898_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0898 NON-STANDARDIZED ALLERGENIC Treatment Set TS348491 Treatment Set TS348491 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20121116 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .002; .0004; .01; .01; 16; 400; 400; 400; 800; .002; 800; .00008 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0899_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0899 NON-STANDARDIZED ALLERGENIC Treatment Set TS348560 Treatment Set TS348560 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ASPERGILLUS FUMIGATUS; BOS TAURUS HAIR; CHENOPODIUM ALBUM POLLEN; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; EPICOCCUM NIGRUM; FRAXINUS AMERICANA POLLEN; FUSARIUM OXYSPORUM; IVA ANNUA VAR. ANNUA POLLEN; JUGLANS NIGRA POLLEN; PERIPLANETA AMERICANA; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; ULMUS AMERICANA POLLEN .002; .002; .002; .002; .002; 80; 80; .002; .002; .002; .002; .002; .002; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0900_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0900 NON-STANDARDIZED ALLERGENIC Treatment Set TS348562 Treatment Set TS348562 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ASPERGILLUS FUMIGATUS; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; EPICOCCUM NIGRUM; FRAXINUS AMERICANA POLLEN; FUSARIUM OXYSPORUM; JUGLANS NIGRA POLLEN; LOLIUM PERENNE POLLEN; PERIPLANETA AMERICANA; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .0004; .002; 4000; 4000; .002; .002; .002; .002; .002; .002; .002; 4000; .002; .002; .002; .002; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49288-0901_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0901 NON-STANDARDIZED ALLERGENIC Treatment Set TS348563 Treatment Set TS348563 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AGROSTIS GIGANTEA POLLEN; ALNUS RHOMBIFOLIA POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; BOS TAURUS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; COCHLIOBOLUS SATIVUS; DACTYLIS GLOMERATA POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; 571.43; .002; .002; .002; 571.43; .002; .001; .001; .002; .002; 571.43; 16; 16; 571.43; .002; .002; .002; 571.43; .002; .002; 571.43; .002; .002; 571.43; .002; .002; .002; .002; .002; .002 g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient] 49288-0902_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0902 NON-STANDARDIZED ALLERGENIC Treatment Set TS348650 Treatment Set TS348650 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; GALLUS GALLUS FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS .00008; .00003; .00003; .002; .00008; .002; .002; 16; 400; 400; .002; .00003; .002; .0004; .002; .002; .001; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0903_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0903 NON-STANDARDIZED ALLERGENIC Treatment Set TS348651 Treatment Set TS348651 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN .000027; .000027; .000027; .002; .001; .001; 16; .002; .00008; .00008; .002; .002; 4000; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0904_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0904 NON-STANDARDIZED ALLERGENIC Treatment Set TS348982 Treatment Set TS348982 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PERIPLANETA AMERICANA; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; SALIX NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .002; .002; .0002; .0002; 400; .002; .002; .002; .002; .002; .002; .001; .0004; .001; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0905_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0905 NON-STANDARDIZED ALLERGENIC Treatment Set TS349185 Treatment Set TS349185 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .002; 4000; .002; .001; .001; .002; .002; .002; .002; .002; .001; .002; .001; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0906_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0906 NON-STANDARDIZED ALLERGENIC Treatment Set TS349186 Treatment Set TS349186 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .002; .00067; .00067; .002; .002; .002; .002; .002; 80; 400; 400; .00067; .002; .002; 4000; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0907_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0907 NON-STANDARDIZED ALLERGENIC Treatment Set TS349163 Treatment Set TS349163 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN .005; .005; .00004; .00004; .002; .002; .002; .002; .005; .0025; .002; .0025; .005; .005; .005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0908_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0908 NON-STANDARDIZED ALLERGENIC Treatment Set TS349162 Treatment Set TS349162 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; RUMEX ACETOSELLA POLLEN; URTICA DIOICA POLLEN .0004; .002; 20000; .002; .002; .002; 400; 2000; .002; 800; .0004; .01; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0909_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0909 NON-STANDARDIZED ALLERGENIC Treatment Set TS349274 Treatment Set TS349274 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. BOS TAURUS HAIR; CANIS LUPUS FAMILIARIS HAIR; EQUUS CABALLUS HAIR; FELIS CATUS HAIR; ODOCOILEUS VIRGINIANUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; PASCOPYRUM SMITHII POLLEN .002; .002; .00008; 2000; .01; .01; .002 g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient] 49288-0910_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0910 NON-STANDARDIZED ALLERGENIC Treatment Set TS349290 Treatment Set TS349290 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .00008; 160; .002; .00004; .00004; .002; .002; .0004; .002; .002; .001; .002; .001; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0911_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0911 NON-STANDARDIZED ALLERGENIC Treatment Set TS349291 Treatment Set TS349291 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .00008; .002; .005; .005; 400; 1000; 400; 10000; .005; 4000; .002 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0912_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0912 NON-STANDARDIZED ALLERGENIC Treatment Set TS349357 Treatment Set TS349357 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN .002; .002; 4000; .01 g/mL; g/mL; [BAU]/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0913_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0913 NON-STANDARDIZED ALLERGENIC Treatment Set TS349358 Treatment Set TS349358 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; JUNIPERUS VIRGINIANA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; 800; .0004; .005; .005; 1000; 1000; 400; 4000; .0004; .002; 800; .005; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0914_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0914 NON-STANDARDIZED ALLERGENIC Treatment Set TS349573 Treatment Set TS349573 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; URTICA DIOICA POLLEN .002; 4000; .00008; .00004; .00004; 16; 400; 400; 160; .002; .002; .00008; 160; .002; .002; .002; .002; .00008; .002 g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0915_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0915 NON-STANDARDIZED ALLERGENIC Treatment Set TS349574 Treatment Set TS349574 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN .002; .002; 4000; .002; .00004; .00004; .002; .0004; .002; .002; .002; .005; .002; .005; .00008; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0916_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0916 NON-STANDARDIZED ALLERGENIC Treatment Set TS349575 Treatment Set TS349575 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN .0004; .005; .00008; .005; .005; .002; 400; 1000; 400; .002; 160 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; g/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0917_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0917 NON-STANDARDIZED ALLERGENIC Treatment Set TS349576 Treatment Set TS349576 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; AVENA SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES PTERONYSSINUS; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; QUERCUS ALBA POLLEN .002; .005; .00008; .001; .001; .005; 1000; .005; .005; .002; 160; .005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0918_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0918 NON-STANDARDIZED ALLERGENIC Treatment Set TS349577 Treatment Set TS349577 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; EQUUS CABALLUS HAIR; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; JUNIPERUS VIRGINIANA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN .005; .005; 160; .005; .0002; .0002; .00008; 400; 4000; .00008; .002; 10000 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0919_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0919 NON-STANDARDIZED ALLERGENIC Treatment Set TS349631 Treatment Set TS349631 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .00008; .00008; 160; .00008; .00004; .00004; .002; .00008; .00008; .00008; .00008; .0004; .0004; .001; .0004; .001; .00008; .002; .0004; .0004; .0004 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0920_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0920 NON-STANDARDIZED ALLERGENIC Treatment Set TS349632 Treatment Set TS349632 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AVENA SATIVA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .00008; 80; 160; .0004; 160; .00008 g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0921_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0921 NON-STANDARDIZED ALLERGENIC Treatment Set TS349705 Treatment Set TS349705 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; ULMUS AMERICANA POLLEN .002; .002; .002; 800; .002; .002; 400; 800; .002; .002; .002; .002; 160; .002; .002; .001; .002; .001; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] 49288-0922_e266b12c-c311-4e1b-9d5a-1f448a15eb0e 49288-0922 NON-STANDARDIZED ALLERGENIC Treatment Set TS349778 Treatment Set TS349778 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .00008; 160; .002; .00004; .00004; .0004; .00008; .0004; .0004; .00008; .00008; .00008; .001; .0004; .001; .002; .00008; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0923_e266b12c-c311-4e1b-9d5a-1f448a15eb0e 49288-0923 NON-STANDARDIZED ALLERGENIC Treatment Set TS349779 Treatment Set TS349779 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .0004; .002; 16; 16; 16; 400; 160; .0004; 160; .00008 g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0924_e266b12c-c311-4e1b-9d5a-1f448a15eb0e 49288-0924 NON-STANDARDIZED ALLERGENIC Treatment Set TS349815 Treatment Set TS349815 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FUMIGATUS; DERMATOPHAGOIDES FARINAE; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .01; 2000; .01 g/mL; [AU]/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0925_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0925 NON-STANDARDIZED ALLERGENIC Treatment Set TS349930 Treatment Set TS349930 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .0004; 4000; .0004; .002; .002; 16; 4000; .002; .0004; .002; .002; 160; .002; .002; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0926_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0926 NON-STANDARDIZED ALLERGENIC Treatment Set TS349931 Treatment Set TS349931 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN 20000; .00008; .005; .005; 400; 800; .0004; .00008; 160; .01; .00008 [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0927_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0927 NON-STANDARDIZED ALLERGENIC Treatment Set TS349945 Treatment Set TS349945 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; EQUUS CABALLUS HAIR; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; .002; .002; .002; .001; .001; 400; 400; .00008; 400; 4000; .002; .002; .002; .002; .002; 4000; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] 49288-0928_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0928 NON-STANDARDIZED ALLERGENIC Treatment Set TS350093 Treatment Set TS350093 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .00008; 160; .0004; .0004; .00004; .00004; .0004; 16; .00008; .0004; .0004; .0004; .002; 4000; .002; .002; .001; .00008; .001; .0004; .00008; .0004; .0004; .0004; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0929_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0929 NON-STANDARDIZED ALLERGENIC Treatment Set TS350094 Treatment Set TS350094 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR .00008; .01; .002; 16; 80; 16 g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0930_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0930 NON-STANDARDIZED ALLERGENIC Treatment Set TS350242 Treatment Set TS350242 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; GALLUS GALLUS FEATHER; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PERIPLANETA AMERICANA; PLEOSPORA HERBARUM; POA PRATENSIS POLLEN; RHIZOPUS STOLONIFER; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; SPORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; USTILAGO CYNODONTIS .00008; .002; .000027; .000027; .000027; .00067; .00067; .002; .0004; .00004; .00004; .002; 400; 16; 16; 80; .0004; .00067; .002; .00008; .002; .002; .002; 160; .002; .002; .002; .001; .0004; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] 49288-0931_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0931 NON-STANDARDIZED ALLERGENIC Treatment Set TS350256 Treatment Set TS350256 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .0004; 4000; .00008; .00004; .00004; .002; .0004; .00008; .0004; .00008; .0004; .0004; .001; .00008; .001; .00008; .002; .002; .0004; .0004 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0932_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0932 NON-STANDARDIZED ALLERGENIC Treatment Set TS350257 Treatment Set TS350257 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AVENA SATIVA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .00008; 16; 800; .0004; 800; .00008 g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0933_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0933 NON-STANDARDIZED ALLERGENIC Treatment Set TS350393 Treatment Set TS350393 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .002; 800; .002; .0002; .0002; .002; .002; .0004; .00008; .002; .002; .0004; .0002; .0004; .0002; .00008; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0934_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0934 NON-STANDARDIZED ALLERGENIC Treatment Set TS350394 Treatment Set TS350394 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AVENA SATIVA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .00008; 16; 160; .0004; .002; 160; .00008 g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0935_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0935 NON-STANDARDIZED ALLERGENIC Treatment Set TS350534 Treatment Set TS350534 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; POPULUS ALBA POLLEN; POPULUS NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; 4000; .002; .005; .001; .001; 400; .005; .002; .002; 4000; .0025; .0025; .002; .005 g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0936_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0936 NON-STANDARDIZED ALLERGENIC Treatment Set TS350533 Treatment Set TS350533 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; COCHLIOBOLUS SATIVUS; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN .005; .005; .001; .001; .0004; 10000; .005; .0004; .002; .005; 4000; .0004; .005; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0937_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0937 NON-STANDARDIZED ALLERGENIC Treatment Set TS350535 Treatment Set TS350535 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; .002; 800; .002; .001; .001; .002; 400; 400; 4000; .002; .002; .002; .002; .002; 4000; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] 49288-0938_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0938 NON-STANDARDIZED ALLERGENIC Treatment Set TS350565 Treatment Set TS350565 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES PTERONYSSINUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .0004; 400; .002 g/mL; [AU]/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0939_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0939 NON-STANDARDIZED ALLERGENIC Treatment Set TS350566 Treatment Set TS350566 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; BETULA ALLEGHANIENSIS POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA PAPYRIFERA POLLEN; BETULA POPULIFOLIA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; IVA XANTHIFOLIA POLLEN; KOCHIA SCOPARIA POLLEN; PHLEUM PRATENSE POLLEN; QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN .002; .00167; .00167; .00167; .00167; .00167; .00167; .002; .001; .001; .002; 160; .0033; .0033; .0033; .001; .001; .002; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0940_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0940 NON-STANDARDIZED ALLERGENIC Treatment Set TS350619 Treatment Set TS350619 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; PHLEUM PRATENSE POLLEN; QUERCUS RUBRA POLLEN 304.04; 10000; .01 [BAU]/mL; [BAU]/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0941_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0941 NON-STANDARDIZED ALLERGENIC Treatment Set TS350623 Treatment Set TS350623 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .002; 800; .002; .001; .001; .002; .002; .002; .002; .002; .002; .001; .002; .001; .00008; .002; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0942_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0942 NON-STANDARDIZED ALLERGENIC Treatment Set TS350622 Treatment Set TS350622 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .002; .00008; .002; .002; 16; 400; 800; .002; 160; .0004 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0943_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0943 NON-STANDARDIZED ALLERGENIC Treatment Set TS350663 Treatment Set TS350663 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; BETULA POPULIFOLIA POLLEN; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; ULMUS AMERICANA POLLEN .002; 4000; .002; .002; .002; .002; 400; 400; 4000; .002; .002; 4000; .001; .002; .001; .002 g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0944_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0944 NON-STANDARDIZED ALLERGENIC Treatment Set TS350905 Treatment Set TS350905 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; PERIPLANETA AMERICANA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; USTILAGO AVENAE; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .00008; .00013; .00013; .002; .00008; .00008; .00008; .002; .00008; 80; 16; 16; .00013; .00008; .0004; 10.00008; .0005; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient] 49288-0945_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0945 NON-STANDARDIZED ALLERGENIC Treatment Set TS350906 Treatment Set TS350906 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .00008; .000027; .000027; .000027; .00008; .00004; .00004; .002; 16; .00008; .002; .00008; .00008; 160; .0004; .00008; .002; .002; .0004 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0946_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0946 NON-STANDARDIZED ALLERGENIC Treatment Set TS351004 Treatment Set TS351004 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AVENA SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; FUSARIUM OXYSPORUM; JUNIPERUS VIRGINIANA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN .002; .0004; .001; .001; .002; 80; .01; .01; .0004; 160 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0947_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0947 NON-STANDARDIZED ALLERGENIC Treatment Set TS351003 Treatment Set TS351003 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .00008; 800; .00008; .0004; .0002; .0002; .0004; 80; 400; 4000; .002; .0004; .0004; .0004; 4000; .002; .00008; .0004; .00008; .0004; .002; .002; .002; .0004 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] 49288-0948_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0948 NON-STANDARDIZED ALLERGENIC Treatment Set TS351030 Treatment Set TS351030 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANIS LUPUS FAMILIARIS HAIR; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FUSARIUM OXYSPORUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; SPORISORIUM CRUENTUM; USTILAGO AVENAE; USTILAGO CYNODONTIS; USTILAGO MAYDIS; USTILAGO NUDA HORDEI; USTILAGO TRITICI .0004; .00008; .0004; .002; .0004; .0004; 16; 16; 16; .0004; .0004; .002; .002; .0004; .002; .0002; .0001; .0002; .0001; .0001; .0001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49288-0949_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0949 NON-STANDARDIZED ALLERGENIC Treatment Set TS351031 Treatment Set TS351031 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA NIGRA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOCHIA SCOPARIA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .0004; .002; .000027; .000027; .000027; .00008; .0002; .0002; .002; .00008; .002; .00008; .002; .00008; 160; .00008; .00008; .0004; .002; .0004; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE] 49288-0950_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0950 NON-STANDARDIZED ALLERGENIC Treatment Set TS351125 Treatment Set TS351125 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; ASPERGILLUS FUMIGATUS; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN .002; .002; .002; .002; .01; .001; .001; 2000; 4000; .01; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0951_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0951 NON-STANDARDIZED ALLERGENIC Treatment Set TS351129 Treatment Set TS351129 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; 4000; .002; .002; .001; .001; 400; 400; .002; .002; .002; .002; 4000; .002; .002; .0004; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0952_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0952 NON-STANDARDIZED ALLERGENIC Treatment Set TS351142 Treatment Set TS351142 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; PHLEUM PRATENSE POLLEN; QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SORGHUM HALEPENSE POLLEN .005; .005; 20000; .0033; .0033; .0033; .005; .005; .01 g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0953_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0953 NON-STANDARDIZED ALLERGENIC Treatment Set TS351167 Treatment Set TS351167 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; ALTERNARIA ALTERNATA; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ASPERGILLUS FUMIGATUS; BOS TAURUS HAIR; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; EQUUS CABALLUS HAIR; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; GALLUS GALLUS FEATHER; MORUS RUBRA POLLEN; ODOCOILEUS VIRGINIANUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; ULMUS AMERICANA POLLEN .002; .002; .002; 4000; .00067; .00067; .002; .002; .002; .002; .002; 400; 4000; .00067; .002; .002; .002; .002; 4000; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient] 49288-0954_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0954 NON-STANDARDIZED ALLERGENIC Treatment Set TS351200 Treatment Set TS351200 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .0004; 4000; .002; .00004; .00004; .002; .00008; .002; .002; .002; .002; .002; .002; .002; .0004; .0004; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0955_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0955 NON-STANDARDIZED ALLERGENIC Treatment Set TS351201 Treatment Set TS351201 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AVENA SATIVA POLLEN; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .01; .002; .01; 400; 2000; .002; 4000; .002 g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0957_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0957 NON-STANDARDIZED ALLERGENIC Treatment Set TS351312 Treatment Set TS351312 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS AMERICANA POLLEN .002; 800; .0004; .001; .001; 400; 400; 400; 4000; .002; .002; 4000; .002; .002; .002; .002; .002; .002; .002 g/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0958_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0958 NON-STANDARDIZED ALLERGENIC Treatment Set TS351313 Treatment Set TS351313 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; EQUUS CABALLUS HAIR; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .002; .00008; .001; .001; .002; .002; .002; .002; .002; .002; .001; .002; .001; .0004; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0959_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0959 NON-STANDARDIZED ALLERGENIC Treatment Set TS351314 Treatment Set TS351314 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN .0004; .00008; 4000; .00008; .00004; .00004; .002; .0004; .002; .002; .0004; .002; .002; .0004; .00008; .000008; .0004; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-0960_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0960 NON-STANDARDIZED ALLERGENIC Treatment Set TS351315 Treatment Set TS351315 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; AVENA SATIVA POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; FESTUCA PRATENSIS POLLEN; PASCOPYRUM SMITHII POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN .005; .005; .002; 400; 1000; 16; 4000; .002; 160; .005 g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49288-9932_60ce9c8c-5855-42da-91ee-8bfe8edf51ab 49288-9932 HUMAN PRESCRIPTION DRUG Sterile Diluent for Allergenic Extract Glycerine and Phenol INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GLYCERIN; PHENOL .1; .004 mL/mL; mL/mL Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient] 49288-9933_60ce9c8c-5855-42da-91ee-8bfe8edf51ab 49288-9933 HUMAN PRESCRIPTION DRUG Sterile Diluent for Allergenic Extract Phenol INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PHENOL .004 mL/mL 49288-9934_60ce9c8c-5855-42da-91ee-8bfe8edf51ab 49288-9934 HUMAN PRESCRIPTION DRUG Sterile Diluent for Allergenic Extract Human Albumin and Phenol INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ALBUMIN (HUMAN); PHENOL .0003; .004 mL/mL; mL/mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 49288-9935_60ce9c8c-5855-42da-91ee-8bfe8edf51ab 49288-9935 HUMAN PRESCRIPTION DRUG Sterile Diluent for Allergenic Extract Glycerine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GLYCERIN .5 mL/mL Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient] 49288-9936_60ce9c8c-5855-42da-91ee-8bfe8edf51ab 49288-9936 HUMAN PRESCRIPTION DRUG Sterile Diluent for Allergenic Extract Glycerine and Phenol INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GLYCERIN; PHENOL .25; .004 mL/mL; mL/mL Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient] 49291-0001_e661c666-7c81-4242-a856-6df998b4b23f 49291-0001 HUMAN OTC DRUG SHERO Arnica Montana, Galium Aparine, Hepar Suis, L-Isoleucine, L-Leucine, L-Valine, Pituitary (Suis), Hyaluronic Acid, IGF-1, Elk Velvet Antler LIQUID ORAL 20130913 UNAPPROVED HOMEOPATHIC Hero LLC .ALPHA.-TOCOPHEROL; ARGININE PYROGLUTAMATE; ARNICA MONTANA; CERVUS ELAPHUS VELVET; CHROMIUM; COENZYME A; FERULIC ACID; GALIUM APARINE; GLUTAMINE; HYALURONIC ACID; ISOLEUCINE; LEUCINE; LEVOCARNITINE; MECASERMIN; NADH; NITRIC ACID; ORNITHINE .ALPHA.-KETOGLUTARATE; PORK LIVER; PRASTERONE; PREGNENOLONE; RIBOSE, D-; SOMATROPIN; SUS SCROFA PITUITARY GLAND; TRYPSIN; VALINE 4; 30; 3; 9; 30; 30; 100; 4; 12; 9; 9; 9; 12; 9; 30; 14; 3; 6; 30; 12; 12; 30; 9; 18; 9 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 49291-0002_948225d1-6330-4817-8553-690cfa92f1b5 49291-0002 HUMAN OTC DRUG Hero Arnica Montana, Galium Aparine, Hepar Suis, L-Isoleucine, L-Leucine, L-Valine, Pituitary, Hyaluronic Acid, IGF-1, Elk Velvet Antler, LIQUID ORAL 20131015 UNAPPROVED HOMEOPATHIC Hero .ALPHA.-TOCOPHEROL; ARGININE PYROGLUTAMATE; ARNICA MONTANA; CERVUS ELAPHUS VELVET; CHROMIUM; COENZYME A; CREATINE MONOHYDRATE; FERULIC ACID; GALIUM APARINE; GLUTAMINE; HYALURONIC ACID; ISOLEUCINE; LEUCINE; LEVOCARNITINE; MECASERMIN; NADH; NITRIC ACID; ORNITHINE .ALPHA.-KETOGLUTARATE; PORK LIVER; PRASTERONE; PREGNENOLONE; RIBOSE, D-; SOMATROPIN; SUS SCROFA PITUITARY GLAND; TRYPSIN; VALINE 4; 30; 3; 9; 30; 30; 100; 100; 4; 12; 9; 9; 9; 12; 9; 30; 14; 3; 6; 30; 12; 12; 30; 9; 18; 9 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 49291-0003_44b80bc9-0829-42d7-b58d-c3aa5d203beb 49291-0003 HUMAN OTC DRUG Super Hero Arnica Montana, Galium Aparine, Hepar Suis, L-Isoleucine, L-Leucine, L-Valine, Pituitary, Hyaluronic Acid, IGF-1, Elk Velvet Antler, LIQUID ORAL 20131015 UNAPPROVED HOMEOPATHIC Hero .ALPHA.-TOCOPHEROL; ARGININE PYROGLUTAMATE; ARNICA MONTANA; CERVUS ELAPHUS VELVET; CHROMIUM; COENZYME A; CREATINE MONOHYDRATE; FERULIC ACID; GALIUM APARINE; GLUTAMINE; HYALURONIC ACID; ISOLEUCINE; LEUCINE; LEVOCARNITINE; MECASERMIN; NADH; NITRIC ACID; ORNITHINE .ALPHA.-KETOGLUTARATE; PORK LIVER; PRASTERONE; PREGNENOLONE; RIBOSE, D-; SOMATROPIN; SUS SCROFA PITUITARY GLAND; TESTOSTERONE; TRYPSIN; VALINE 4; 30; 3; 9; 30; 30; 100; 100; 4; 12; 9; 9; 9; 12; 9; 30; 14; 3; 6; 30; 12; 12; 30; 9; 100; 18; 9 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 49295-0001_54d1dd69-9ec9-40a9-bd16-f8b84d59bba2 49295-0001 HUMAN OTC DRUG GH not applicable SPRAY ORAL 20140714 UNAPPROVED HOMEOPATHIC Oxylife Nutritional Supplements Inc PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49299-1090_98e43dc4-f14a-498d-ac18-fc4c2695a71c 49299-1090 HUMAN PRESCRIPTION DRUG LIPITOR atorvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA020702 PHARMAKON, LLC ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49299-1091_98e43dc4-f14a-498d-ac18-fc4c2695a71c 49299-1091 HUMAN PRESCRIPTION DRUG LIPITOR atorvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA020702 PHARMAKON, LLC ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49299-1092_98e43dc4-f14a-498d-ac18-fc4c2695a71c 49299-1092 HUMAN PRESCRIPTION DRUG LIPITOR atorvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA020702 PHARMAKON, LLC ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49299-1093_98e43dc4-f14a-498d-ac18-fc4c2695a71c 49299-1093 HUMAN PRESCRIPTION DRUG LIPITOR atorvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA020702 PHARMAKON, LLC ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49304-0001_1dc4a436-7d10-499c-ac67-f47663ab3a4f 49304-0001 HUMAN OTC DRUG Male Energy Dehydroepiandrosterone, Sabal serrulata, Setotonin, Orchitinum (suis), Pituitary (suis), Thyroidinum (suis), Conium maculatum, Testosterone, LIQUID ORAL 20120507 UNAPPROVED HOMEOPATHIC Alternative Pharmacy CONIUM MACULATUM FLOWERING TOP; PRASTERONE; SAW PALMETTO; SEROTONIN; SUS SCROFA PITUITARY GLAND; SUS SCROFA TESTICLE; TESTOSTERONE; THYROID, PORCINE 12; 6; 6; 6; 8; 8; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49304-0002_7071dbcf-470c-4138-9831-56fd6cd15a45 49304-0002 HUMAN OTC DRUG Happy Happy Aurum Metallicum, Lithium Carbonicum, Serotonin LIQUID ORAL 20121022 UNAPPROVED HOMEOPATHIC Alternative Pharmacy GOLD; LITHIUM CARBONATE; SEROTONIN HYDROCHLORIDE 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49304-0003_96a2a02c-b341-4da1-8363-7fd38bc94c0e 49304-0003 HUMAN OTC DRUG Happy Bones Boron, Calcarea carbonica, Calcarea fluorica, Calcarea hypophosphorosa, Calcarea phosphorica, Hekla lava, Mezereum, Natrum phosphoricum, Silicea, Symphytum oficinale, Urtica dioica, Vanadium metallicum, LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC Alternative Pharmacy BORON; CALCIUM FLUORIDE; CALCIUM HYPOPHOSPHITE; COMFREY ROOT; DAPHNE MEZEREUM BARK; HEKLA LAVA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TRIBASIC CALCIUM PHOSPHATE; URTICA DIOICA; VANADIUM 12; 8; 6; 6; 6; 12; 30; 12; 6; 8; 4; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49304-0004_d7d62cf3-c32b-4fb9-abd8-e6d5315275d1 49304-0004 HUMAN OTC DRUG Flexible Arnica montana, Causticum, Colchicum autumnale, Hypericum perforatum, Kalmia Latifolia, Phytolacca decandra, Rhododendrom chrysanthum, LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC Alternative Pharmacy ARNICA MONTANA; CAUSTICUM; COLCHICUM AUTUMNALE BULB; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; URTICA URENS; ZINC 6; 6; 6; 6; 12; 6; 4; 4; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49304-0005_8b2fd8dd-9afe-4423-9318-937f7b429199 49304-0005 HUMAN OTC DRUG Cold and Flu Solution Aconitum Napellus, Belladonna, Echinacea, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ferrum Phosphoricum, Anas Barbariae, Hepatis Et Cordis Extractum LIQUID ORAL 20130910 UNAPPROVED HOMEOPATHIC Alternative Pharmacy ACONITUM NAPELLUS; ATROPA BELLADONNA; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT 3; 3; 200; 3; 3; 4; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 49304-0006_a79e6e2e-2d65-4ab5-9231-4b1a4d996c72 49304-0006 HUMAN OTC DRUG Quiet Calm Ammonium Bromatum, Avena Sativa, Chamomilla, Coffea Cruda, Gelsemium Sempervirens, Phosphoricum Acidum LIQUID ORAL 20130306 UNAPPROVED HOMEOPATHIC Alternative Pharmacy AMMONIUM BROMIDE; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA RECUTITA; PHOSPHORIC ACID; TRYPTOPHAN; VALERIAN 3; 6; 1; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49304-0007_082f9e0b-5c1a-478c-beb4-107f5625b4f5 49304-0007 HUMAN OTC DRUG High Potency Heal Grief Ignatia Amara, Natrum Muriaticum, Staphysagria LIQUID ORAL 20130424 UNAPPROVED HOMEOPATHIC Alternative Pharmacy DELPHINIUM STAPHISAGRIA SEED; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 200; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49304-0008_921e1d20-90a3-4f87-bd02-6c0081145c2e 49304-0008 HUMAN OTC DRUG Nighty Nite Grindelia, Melatonin, Passiflora Incarnata LIQUID ORAL 20130424 UNAPPROVED HOMEOPATHIC Alternative Pharmacy GRINDELIA HIRSUTULA FLOWERING TOP; MELATONIN; PASSIFLORA INCARNATA FLOWERING TOP 6; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49304-0009_ee7dc06c-85c6-4b92-8f82-f57919cc6b91 49304-0009 HUMAN OTC DRUG ADRENAL ENERGY Berberis Vulgaris, Agaricus Muscarius, Urtica Urens, Glandula Suprarenalis Bovinum, Echinacea, Atropinum Sulphuricum, Ceanothus Americanus LIQUID ORAL 20130809 UNAPPROVED HOMEOPATHIC Alternative Pharmacy AMANITA MUSCARIA FRUITING BODY; ATROPINE SULFATE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; CEANOTHUS AMERICANUS LEAF; ECHINACEA, UNSPECIFIED; URTICA URENS 3; 12; 3; 8; 8; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49304-0010_4892c6ea-ea0b-4500-a279-1006801c9e96 49304-0010 HUMAN OTC DRUG UR IN CONTROL Apis Mellifica, Argentum Nitricum, Belladonna, Cantharis, Causticum, Equsetum Arvense, Petroselinum Sativum, Pulsatilla, Sarsaparilla, Terebinthina LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC Alternative Pharmacy APIS MELLIFERA; ATROPA BELLADONNA; CAUSTICUM; EQUISETUM ARVENSE TOP; LYTTA VESICATORIA; PETROSELINUM CRISPUM; PULSATILLA VULGARIS; SARSAPARILLA; SILVER NITRATE; TURPENTINE OIL 6; 4; 8; 6; 6; 8; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49304-0011_52739b96-46d8-4166-a655-a478be6a73b4 49304-0011 HUMAN OTC DRUG Stay Well Argentum Nitricum, Baptisia Tinctoria, Echinacea, Echinacea Purpurea, Galium Aparine, Phosphorus, Pulstilla, Sulphur, Thuma Occidentalis, Thymus Serpyllum LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC Alternative Pharmacy BAPTISIA TINCTORIA; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; GALIUM APARINE; PHOSPHORUS; PULSATILLA VULGARIS; SILVER NITRATE; SULFUR; THUJA OCCIDENTALIS LEAF; THYMUS SERPYLLUM 6; 3; 6; 6; 6; 6; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49304-0012_3ed1caa2-68b9-4773-8f06-f99fe25bfd7a 49304-0012 HUMAN OTC DRUG Thyroid Rhythm Adrenalinum, Calarea Carbonica, Calcarea Fluorica, Calcarea Iodata, Ferrum Iodatum, Fucus Vesiculosus, Iodium, Kali Iodatum, Naturm Muriaticum LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC Alternative Pharmacy BOS TAURUS PITUITARY GLAND; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM FLUORIDE; CALCIUM IODIDE; EPINEPHRINE; FERROUS IODIDE; FUCUS VESICULOSUS; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM IODIDE; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID 6; 6; 6; 8; 6; 6; 8; 6; 9; 30; 6; 30; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49304-0013_90d29cd7-aa5f-48c2-9f65-62a2a53fbf50 49304-0013 HUMAN OTC DRUG Energize Aralia QuinQuefolia, Avena Sativa, Kali Phosphoricum, Phosphoricum Acidum, Picricum Acidum, Zingiber Officinale LIQUID ORAL 20131002 UNAPPROVED HOMEOPATHIC Alternate Pharmacy AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; GINGER; PHOSPHORIC ACID; PICRIC ACID; POTASSIUM PHOSPHATE, DIBASIC 6; 3; 3; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49304-0014_168698de-198c-449c-a71b-01711b31f383 49304-0014 HUMAN OTC DRUG Happy Happy not applicable LIQUID ORAL 20140724 UNAPPROVED HOMEOPATHIC Alternative Pharmacy GOLD; LITHIUM CARBONATE; SEROTONIN HYDROCHLORIDE 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49304-0015_2d19a4f7-9faf-4c52-8fbd-fe4fab43f725 49304-0015 HUMAN OTC DRUG Stomach Relief not applicable LIQUID ORAL 20140724 UNAPPROVED HOMEOPATHIC Alternative Pharmacy ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; ROBINIA PSEUDOACACIA BARK; STRYCHNOS NUX-VOMICA SEED 30; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 49304-0016_d80fdc5f-2659-4b0b-b9df-52966c11512c 49304-0016 HUMAN OTC DRUG Trauma Drama not applicable LIQUID ORAL 20140724 UNAPPROVED HOMEOPATHIC Alternative Pharmacy ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 30; 6; 6; 6; 30; 6; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 49304-0017_47a8d661-1deb-4a86-b432-cbf6382d5f6e 49304-0017 HUMAN OTC DRUG TICKED Not applicable LIQUID ORAL 20140724 UNAPPROVED HOMEOPATHIC Alternative Pharmacy ACONITUM NAPELLUS; ARNICA MONTANA; BORRELIA BURGDORFERI; CALENDULA OFFICINALIS FLOWERING TOP; EPINEPHRINE; LEDUM PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT 30; 30; 12; 3; 8; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49304-0018_ccd9fbab-7033-440e-9f40-519986a609bd 49304-0018 HUMAN OTC DRUG Happy Heart not applicable LIQUID ORAL 20140724 UNAPPROVED HOMEOPATHIC Alternative Pharmacy ACONITUM NAPELLUS; ARNICA MONTANA; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; POTASSIUM CARBONATE; RANUNCULUS BULBOSUS; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; SULFUR 30; 30; 10; 6; 6; 10; 4; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49304-0019_d8281b61-62c0-4488-a906-d00cbec1791c 49304-0019 HUMAN OTC DRUG Adrenal Energy NOT APPLICABLE LIQUID ORAL 20140902 UNAPPROVED HOMEOPATHIC Alternative Pharmacy AMANITA MUSCARIA FRUITING BODY; ATROPINE SULFATE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; CEANOTHUS AMERICANUS LEAF; ECHINACEA ANGUSTIFOLIA; URTICA URENS 3; 12; 3; 8; 8; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49304-0020_09c56e7a-7a80-4369-a4bb-6a57ef7d5f94 49304-0020 HUMAN OTC DRUG Nighty Nite NOT APPLICABLE LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC Alternative Pharmacy GRINDELIA HIRSUTULA WHOLE; MELATONIN; PASSIFLORA INCARNATA FLOWERING TOP 6; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49310-001_e4155ebe-6b4f-4439-b843-442417acf40c 49310-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090501 UNAPPROVED MEDICAL GAS Fairmont Home Equipment & Supply OXYGEN 990 mL/L 49314-5801_ce039b46-d1d2-40bf-9a2c-d5c177793fb2 49314-5801 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20100728 OTC MONOGRAPH FINAL part348 UniShield HYDROCORTISONE 10 mg/mL 49317-001_aa44f437-54e3-439e-9b2c-4d3ccf219854 49317-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19800101 UNAPPROVED MEDICAL GAS Abbott Welding Supply OXYGEN 995 mL/L 49320-798_738791c3-8599-40ae-a53a-74b498d6ae22 49320-798 HUMAN OTC DRUG vanarex hair regrowth treatment Minoxidil SOLUTION TOPICAL 20110201 ANDA ANDA075598 Manchester Laboratories Inc. MINOXIDIL 3 g/60mL 49344-0001_d5968e24-6663-4f42-bfc0-9547496ca765 49344-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091110 UNAPPROVED MEDICAL GAS Westmoreland Medical Equipment Company OXYGEN 99 L/100L 49348-001_8f85f9af-cf27-45a0-b953-2b18d98db714 49348-001 HUMAN OTC DRUG Sunmark Aspirin Regular Strength Aspirin TABLET ORAL 20030624 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 325 mg/1 49348-002_bff76ac1-ca87-4612-88a7-0c0b8b41f630 49348-002 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 49348-003_f38d9b09-89de-4e50-91d4-ceaebb4524d9 49348-003 HUMAN OTC DRUG Ethyl Rubbing Alcohol Alcohol LIQUID TOPICAL 20090416 OTC MONOGRAPH FINAL part333 McKesson ALCOHOL 70 mL/100mL 49348-004_44d91869-6ab5-41ce-be59-81cfde153d0c 49348-004 HUMAN OTC DRUG Isopropyl rubbing alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20141130 OTC MONOGRAPH NOT FINAL part333A McKesson (Sunmark) ISOPROPYL ALCOHOL 91 mL/100mL 49348-005_40892738-fa0d-4ab4-8609-3c4eda46be7e 49348-005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 McKesson SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 49348-006_c58744ba-2de1-4157-a0eb-78f89239c4fc 49348-006 HUMAN OTC DRUG Mineral Oil Lubricant Laxative mineral oil ENEMA RECTAL 20120716 OTC MONOGRAPH NOT FINAL part334 McKesson MINERAL OIL 118 mL/118mL 49348-007_358d7636-7ea9-45ca-9f1a-2d04bf8cbb8a 49348-007 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70 percent Wintergreen Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A McKesson (Sunmark) ISOPROPYL ALCOHOL 70 mL/100mL 49348-009_53c915cf-676b-4de2-97c5-a3fbd0beac5d 49348-009 HUMAN OTC DRUG sunmark pain reliever Acetaminophen TABLET ORAL 20030823 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 325 mg/1 49348-011_6f70dd64-39b2-4e65-a1d9-8ebe6e9b3ad4 49348-011 HUMAN OTC DRUG Sunmark Calamine Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 20080101 OTC MONOGRAPH FINAL part347 McKesson ZINC OXIDE 160 mg/mL 49348-016_1d93b304-4a8b-4630-90e1-4e2cd05e6e2b 49348-016 HUMAN OTC DRUG Sunmark Castor Oil Castor Oil LIQUID ORAL 20080101 OTC MONOGRAPH NOT FINAL part334 McKesson CASTOR OIL 1 mg/mL 49348-017_6910a1f9-ae8c-4590-8243-64cc6b48afab 49348-017 HUMAN OTC DRUG Sun Mark Tussin DM cough and chest congestion Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20030627 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 49348-019_63aff6c4-b52e-47b5-b9bd-6dbea8be9fb1 49348-019 HUMAN OTC DRUG Sunmark Antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20030913 OTC MONOGRAPH FINAL part332 McKesson ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 49348-020_b2c1d690-33bc-4094-8629-09949f4c1502 49348-020 HUMAN OTC DRUG sunmark antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20030821 OTC MONOGRAPH FINAL part331 Mckesson ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 49348-023_628bdda9-a682-4a97-92a2-8e359ee2a7f6 49348-023 HUMAN OTC DRUG Sunmark Pain Reliever extra strength Acetaminophen TABLET ORAL 20030815 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 49348-024_a040efea-e4fa-4b71-bfa0-8fa53478c8b2 49348-024 HUMAN OTC DRUG Sunmark Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 20030815 OTC MONOGRAPH FINAL part341 McKesson PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 49348-025_b3aa336f-d20e-4490-ad26-82060b20c555 49348-025 HUMAN OTC DRUG Sun Mark Allergy Antihistamine Chlorpheniramine Maleate TABLET ORAL 20030919 OTC MONOGRAPH FINAL part341 McKesson CHLORPHENIRAMINE MALEATE 4 mg/1 49348-026_cc539679-b068-4d74-a885-b3801b84c5e6 49348-026 HUMAN OTC DRUG acid reducer Ranitidine TABLET ORAL 20140107 ANDA ANDA200536 McKesson RANITIDINE HYDROCHLORIDE 150 mg/1 49348-028_378783d7-b473-426b-9bc0-1d421f9d0e78 49348-028 HUMAN OTC DRUG Sunmark Nasal Original oxymetazoline hydrochloride SPRAY NASAL 20030627 OTC MONOGRAPH FINAL part341 McKesson OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL 49348-029_45df6359-262f-442a-bdd5-c7d62d43a449 49348-029 HUMAN OTC DRUG sunmark triple antibiotic polymyxin B sulfate, bacitracin zinc, and neomycin sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B McKesson BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 49348-030_3fdfb563-5654-44e1-86c0-dde7c39e90bd 49348-030 HUMAN OTC DRUG sunmark Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL LIQUID TOPICAL 20120628 OTC MONOGRAPH FINAL part333A McKesson ISOPROPYL ALCOHOL 70 L/100L 49348-031_8e651b12-abbb-4f94-a6bd-8c379ac8c822 49348-031 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090416 OTC MONOGRAPH NOT FINAL part356 Sunmark HYDROGEN PEROXIDE 2.65 mL/100mL 49348-035_c6b8312b-f08c-4dc6-9828-776ffc50e29d 49348-035 HUMAN OTC DRUG sunmark antacid aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 20031020 OTC MONOGRAPH FINAL part331 McKesson ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 49348-038_aef669b9-858d-445e-8979-29e69ffad9ae 49348-038 HUMAN OTC DRUG Sunmark sore throat Phenol SPRAY ORAL 20030710 OTC MONOGRAPH NOT FINAL part356 McKesson PHENOL 1.4 mL/100mL 49348-039_1f694d67-5e41-4bc4-b2d6-1fd0f1d5da1b 49348-039 HUMAN OTC DRUG Healing Petrolatum OINTMENT TOPICAL 20130801 OTC MONOGRAPH FINAL part347 McKesson PETROLATUM 340 mg/g 49348-042_e9b6a011-3e1b-4e3b-ab8f-0a0263551a30 49348-042 HUMAN OTC DRUG Sunmark pain reliever extra strength Acetaminophen TABLET ORAL 20030811 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 49348-044_6449d726-0887-44bd-9ac6-d296ccaf9bd1 49348-044 HUMAN OTC DRUG Sun Mark allergy relief diphenhydramine hydrochloride CAPSULE ORAL 20030703 OTC MONOGRAPH FINAL part341 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49348-045_3365fc64-ea73-4852-83ef-05d4d4e9bf47 49348-045 HUMAN OTC DRUG Sunmark Allergy Relief Antihistamine Diphenhydramine Hydrochloride LIQUID ORAL 20030821 OTC MONOGRAPH FINAL part341 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 49348-047_9bde93d4-81fc-4461-b77e-5f75d49dd0b6 49348-047 HUMAN OTC DRUG Original texture Orange flavor psyllium husk POWDER, FOR SUSPENSION ORAL 20061227 OTC MONOGRAPH NOT FINAL part334 Sunmark PSYLLIUM HUSK 3.4 g/11g 49348-055_efc1f7f7-d605-4ce3-8205-6f19f52f5086 49348-055 HUMAN OTC DRUG SUNMARK Calcium Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20130808 OTC MONOGRAPH FINAL part331 Mckesson CALCIUM CARBONATE 750 mg/1 49348-056_ea16aeba-89fc-4246-b244-4c3f1b267791 49348-056 HUMAN OTC DRUG Childrens allergy relief antihistamine LIQUID ORAL 20130808 OTC MONOGRAPH FINAL part341 Mckesson DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 49348-061_fb153834-0136-4926-adea-29284d2dda0d 49348-061 HUMAN OTC DRUG sunmark nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20111121 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 49348-062_190803e2-7f05-4916-92bf-4513fbd51f44 49348-062 HUMAN OTC DRUG Senna laxative Natural vegetable laxative SENNOSIDES TABLET ORAL 20130220 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) SENNOSIDES 8.6 mg/1 49348-063_ff130d3b-4acc-4a1b-80b9-4077f6e672b3 49348-063 HUMAN OTC DRUG Sunmark Junior Rapid Melts Acetaminophen TABLET, CHEWABLE ORAL 20130801 OTC MONOGRAPH NOT FINAL part343 Mckesson ACETAMINOPHEN 160 mg/1 49348-070_e7855bd6-96cd-41e9-8f07-5937863fa8e9 49348-070 HUMAN OTC DRUG Motion Sickness Original formula Dimenhydrinate TABLET ORAL 20110613 OTC MONOGRAPH FINAL part336 McKesson (Sunmark) DIMENHYDRINATE 50 mg/1 49348-074_96227853-31b8-42d1-bb9f-959be3e118d0 49348-074 HUMAN OTC DRUG Sleep Aid maximum strength Diphenhydramine HCl CAPSULE ORAL 20100709 OTC MONOGRAPH FINAL part341 Mckesson (Sunmark) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 49348-076_6ae78778-70a2-4d82-a3ce-ae82127e055b 49348-076 HUMAN OTC DRUG Sunmark Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20130701 UNAPPROVED DRUG OTHER Mckesson PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 49348-077_9d01dd36-d079-4d65-b8b0-1fbd345b35fc 49348-077 HUMAN OTC DRUG Alcohol Pad isopropyl alcohol SWAB TOPICAL 20030619 OTC MONOGRAPH NOT FINAL part333E McKesson ISOPROPYL ALCOHOL .7 mL/1 49348-078_58e4bb07-ab4b-4beb-a182-f6f85d85eefa 49348-078 HUMAN OTC DRUG Childrens all day allergy Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 McKesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL 49348-080_05ae4cbe-51c1-404d-94b6-f96c778a35a5 49348-080 HUMAN OTC DRUG adult cold, flu and sore throat acteaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 1/20mL; mg/20mL; mg/20mL; mg/20mL 49348-081_04ef9755-612c-43f8-adc8-1d3b114f3fce 49348-081 HUMAN OTC DRUG Sunmark Infants Pain and Fever Acetaminophen LIQUID ORAL 20111025 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL 49348-082_3e0e2dba-cd80-4e1b-b0cb-6e8e918889ec 49348-082 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH FINAL part347 McKesson (Sunmark) DIMETHICONE 125 mg/1 49348-083_22d26c0a-b9f5-4130-89a4-32aab896ece5 49348-083 HUMAN OTC DRUG adult severe congestion and cough Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Mckesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL 49348-090_733836c8-642d-460f-9414-be13e1534fc2 49348-090 HUMAN OTC DRUG Sunmark fiber Smooth Texture psyllium husk POWDER, FOR SUSPENSION ORAL 20061227 OTC MONOGRAPH NOT FINAL part334 McKesson PSYLLIUM HUSK 3.4 g/5.8g 49348-091_f6e43342-8b0c-48ac-a7b6-75466ee1fab0 49348-091 HUMAN OTC DRUG Smooth texture Orange flavor psyllium husk POWDER, FOR SUSPENSION ORAL 20070405 OTC MONOGRAPH NOT FINAL part334 McKesson PSYLLIUM HUSK 3.4 g/12g 49348-093_9100dfb8-62fe-4093-bf19-286ce99be076 49348-093 HUMAN OTC DRUG Sunmark childrens pain and fever Acetaminophen SUSPENSION ORAL 20140124 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL 49348-097_0871053e-dabb-4db1-8363-3be7a4d80ea9 49348-097 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Sunmark IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 49348-100_ba56e384-5c3b-4f21-918c-52f2d59266aa 49348-100 HUMAN OTC DRUG Sunmark cough dm dextromethorphan polistirex SUSPENSION ORAL 20130618 ANDA ANDA091135 McKesson DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 49348-104_30907173-4ae2-4cec-a4ee-b00b24729dff 49348-104 HUMAN OTC DRUG sunmark cold and flu severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20140318 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 49348-107_36f43472-05f0-40c3-be10-08489ad3084e 49348-107 HUMAN OTC DRUG eye itch relief ketotifen fumarate SOLUTION/ DROPS OPHTHALMIC 20140207 ANDA ANDA077958 McKesson Corporation Valu-Rite KETOTIFEN FUMARATE .35 mg/mL 49348-110_256cf9d9-67d1-4f6c-abed-42b9cd7604fc 49348-110 HUMAN OTC DRUG Oral Saline Laxative Cherry dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20120831 OTC MONOGRAPH NOT FINAL part334 McKesson Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 2.7; 7.2 g/15mL; g/15mL 49348-111_37d2d0d2-ed3d-485e-be10-6c29c509e678 49348-111 HUMAN OTC DRUG Oral Saline Laxative Ginger Lemon dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20120831 OTC MONOGRAPH NOT FINAL part334 Mckesson Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 2.7; 7.2 g/15mL; g/15mL 49348-116_062dd7dd-a069-58a1-e054-00144ff8d46c 49348-116 HUMAN OTC DRUG Pain Reliever Rapid Release Acetaminophen TABLET, COATED ORAL 20141024 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 49348-117_066afeed-a4af-3c5e-e054-00144ff8d46c 49348-117 HUMAN OTC DRUG Sinus Congestion and Pain Severe ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141027 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 49348-118_066afeed-a4c3-3c5e-e054-00144ff8d46c 49348-118 HUMAN OTC DRUG Cold and Flu Severe ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141027 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 49348-119_1dd2a128-3da4-4b5e-b467-5317f72324eb 49348-119 HUMAN OTC DRUG sunmark childrens pain and fever Acetaminophen SUSPENSION ORAL 20140428 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL 49348-121_769bd49f-24e5-47fe-bc1a-441f65eefc22 49348-121 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE ORAL 20140530 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) DOCUSATE SODIUM 100 mg/1 49348-122_42fc9282-1fde-42db-a1e5-ef3cbd63189a 49348-122 HUMAN OTC DRUG stool softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20140530 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) DOCUSATE CALCIUM 240 mg/1 49348-123_f36a2341-fed2-4d26-89dd-c998224a9cdd 49348-123 HUMAN OTC DRUG Sunmark Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20140519 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL 49348-125_4a9549f1-a018-46d6-aa63-cac9f7545628 49348-125 HUMAN OTC DRUG STOOL SOFTENER EXTRA STRENGTH DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140530 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) DOCUSATE SODIUM 250 mg/1 49348-128_877e9b4a-f852-4e8e-b22d-3a5c2c2c3cff 49348-128 HUMAN OTC DRUG sunmark acid reducer Famotidine TABLET ORAL 20090910 ANDA ANDA075400 Mckesson FAMOTIDINE 10 mg/1 49348-130_4ec6376e-d1f8-44d5-b9fc-82874af1de01 49348-130 HUMAN OTC DRUG sunmark nasal Oxymetazoline HCl SPRAY NASAL 20140926 OTC MONOGRAPH FINAL part341 McKesson OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 49348-133_4ff55a3c-b85f-4490-87f3-51181e63a8bc 49348-133 HUMAN OTC DRUG Sunmark Iodine IODINE, SODIUM IODIDE, ALCOHOL TINCTURE TOPICAL 20120628 OTC MONOGRAPH FINAL part333A McKesson ALCOHOL; IODINE; SODIUM IODIDE 470; 20; 20.4 mg/mL; mg/mL; mg/mL 49348-135_a1e90b56-8b63-44b4-91f2-375f4bae0989 49348-135 HUMAN OTC DRUG sunmark tussin Guaifenesin SYRUP ORAL 20140917 OTC MONOGRAPH FINAL part341 McKesson GUAIFENESIN 200 mg/10mL 49348-138_6d414111-ad02-4d2e-a138-9e76f1042cae 49348-138 HUMAN OTC DRUG Sunmark Benzoin Compound Tincture Benzoin Resin LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part356 McKesson BENZOIN RESIN 1000 mg/mL 49348-148_b84a2d3e-a89c-4baf-9432-7abbdaf2957e 49348-148 HUMAN OTC DRUG Sunmark Camphor Spirit Camphor 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part348 McKesson CAMPHOR (NATURAL) 100 mg/mL 49348-154_75e3ef84-b7c8-440c-ac49-42bd8f7d5ca2 49348-154 HUMAN OTC DRUG antibiotic Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B McKesson BACITRACIN ZINC 500 [iU]/g 49348-155_155ba245-491d-4a85-be99-f49786e61cd9 49348-155 HUMAN OTC DRUG sunmark antifungal Tolnaftate CREAM TOPICAL 20060217 OTC MONOGRAPH FINAL part333C McKesson TOLNAFTATE 10 mg/g 49348-158_6813476e-56c3-4726-8579-17d570c9fb30 49348-158 HUMAN OTC DRUG Infant Glycerin Laxative Glycerin SUPPOSITORY RECTAL 20050909 OTC MONOGRAPH FINAL part334 McKesson GLYCERIN 1.3 g/1 49348-159_d4b0c77c-9a3d-4bae-b4f9-bf6defbdc796 49348-159 HUMAN OTC DRUG Adult Glycerin Laxative Glycerin SUPPOSITORY RECTAL 20050803 OTC MONOGRAPH FINAL part334 McKesson GLYCERIN 1.614 g/1 49348-163_d5d54385-3cf2-4a1a-a05a-1808f4f540cb 49348-163 HUMAN OTC DRUG Sunmark eye itch relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20120221 ANDA ANDA077958 McKesson KETOTIFEN FUMARATE .25 mg/mL 49348-166_fc371d60-ee74-48e9-9848-fc45de771053 49348-166 HUMAN OTC DRUG Fiber original texture psyllium husk POWDER, FOR SUSPENSION ORAL 20070115 OTC MONOGRAPH NOT FINAL part334 McKesson PSYLLIUM HUSK 3.4 g/7g 49348-169_7418e4e8-d8c9-48bf-aa0c-016641edec8c 49348-169 HUMAN OTC DRUG SUNMARK CALCIUM ANTACID REGULAR STRENGTH calcium carbonate TABLET, CHEWABLE ORAL 20030818 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 500 mg/1 49348-170_d91efb89-5752-45a4-97b3-4b10412c5192 49348-170 HUMAN OTC DRUG Sunmark calcium antacid regular strength calcium carbonate TABLET, CHEWABLE ORAL 20030821 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 500 mg/1 49348-177_dce5dcc2-0f77-454f-b5bc-71e3cb41fcda 49348-177 HUMAN OTC DRUG Sun Mark Stomach Relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20030821 OTC MONOGRAPH FINAL part335 McKesson BISMUTH SUBSALICYLATE 262 mg/1 49348-183_ec0dc654-1569-4dbc-8dd0-ceacea213711 49348-183 HUMAN OTC DRUG sunmark loratadine d Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120306 ANDA ANDA076050 McKesson LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 49348-191_babf9ee4-5bc2-48a4-ab23-022149abea52 49348-191 HUMAN OTC DRUG sunmark aspirin Aspirin TABLET, CHEWABLE ORAL 20030906 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 49348-192_d10a227f-e59e-4fdb-82d2-5ddd355ee59f 49348-192 HUMAN OTC DRUG sunmark stomach relief Bismuth subsalicylate LIQUID ORAL 20030821 OTC MONOGRAPH FINAL part335 McKesson BISMUTH SUBSALICYLATE 262 mg/15mL 49348-194_cd29df82-f867-4c8a-a090-4de332e2f97a 49348-194 HUMAN OTC DRUG Sunmark antacid extra strength Aluminum hydroxide, Magnesium carbonate TABLET, CHEWABLE ORAL 20030821 OTC MONOGRAPH FINAL part331 McKesson ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 49348-195_581646e4-0d30-46db-b968-1e3ab4458167 49348-195 HUMAN OTC DRUG Sunmark Calcium Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20030715 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 1000 mg/1 49348-196_a8507ff0-b9ab-415d-acbc-ea424e35d12c 49348-196 HUMAN OTC DRUG sunmark ibuprofen Ibuprofen TABLET, COATED ORAL 20030624 ANDA ANDA072096 McKesson IBUPROFEN 200 mg/1 49348-197_b9ff66ec-362d-4013-aaba-e16d46a06685 49348-197 HUMAN OTC DRUG Sunmark Nose Phenylephrine hydrochloride LIQUID NASAL 20030821 OTC MONOGRAPH FINAL part341 McKesson PHENYLEPHRINE HYDROCHLORIDE 1 mL/100mL 49348-207_06fecf96-2277-4acf-b9c2-7ef72bf28021 49348-207 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090416 OTC MONOGRAPH FINAL part333 Sunmark ISOPROPYL ALCOHOL 70 mL/100mL 49348-208_a171572e-cc4e-4bc0-8763-8a43a7230b08 49348-208 HUMAN OTC DRUG Wintergreen Isopropyl Alcohol Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20090409 OTC MONOGRAPH FINAL part333 Sunmark ISOPROPYL ALCOHOL 70 mL/100mL 49348-214_ad058b54-962d-4b70-8040-541b4e2ce409 49348-214 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090416 OTC MONOGRAPH NOT FINAL part356 Sunmark HYDROGEN PEROXIDE 2.65 mL/100mL 49348-223_df5055cf-5cdc-4928-8287-f1ba37b6f8a0 49348-223 HUMAN OTC DRUG Sunmark womans laxative Bisacodyl TABLET, COATED ORAL 20030914 OTC MONOGRAPH NOT FINAL part334 McKesson BISACODYL 5 mg/1 49348-224_c318abc8-00ea-4d3f-b3d3-768e86f1c819 49348-224 HUMAN OTC DRUG Laxative pills maximum strength Sennosides TABLET ORAL 20100710 OTC MONOGRAPH NOT FINAL part334 Mckesson (Sunmark) SENNOSIDES 25 mg/1 49348-228_7e4efc66-24a0-44c7-8e03-48a3ef58fed8 49348-228 HUMAN OTC DRUG Sunmark ibuprofen childrens Ibuprofen SUSPENSION ORAL 20030919 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL 49348-229_6bccf2a8-79a0-4f42-a3fe-0995e24c1f0c 49348-229 HUMAN OTC DRUG sunmark ibuprofen Ibuprofen SUSPENSION ORAL 20030919 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL 49348-230_3b94ef94-5887-4002-b123-689e46aeed23 49348-230 HUMAN OTC DRUG sunmark nasal Oxymetazoline HCl SPRAY NASAL 20030919 OTC MONOGRAPH FINAL part341 McKesson OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 49348-231_a99b482f-9a9e-4893-8344-7898f56f4289 49348-231 HUMAN OTC DRUG Sunmark Nasal oxymetazoline hydrochloride SPRAY NASAL 20030624 OTC MONOGRAPH FINAL part341 McKesson OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 49348-233_b6b94f7e-e500-400b-bdef-0f3ff497d469 49348-233 HUMAN OTC DRUG PAIN RELIEVER PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130308 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 49348-236_2e9d4c3c-e348-49dd-a719-6f4f479bbdc4 49348-236 HUMAN OTC DRUG pain reliever pm extra strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20130326 OTC MONOGRAPH NOT FINAL part343 McKesson (Sunmark) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 49348-246_af3fb1fb-9871-46d7-b8ff-ab6fcb804283 49348-246 HUMAN OTC DRUG SunMark heartburn relief acid reducer Cimetidine TABLET ORAL 20030919 ANDA ANDA075285 McKesson CIMETIDINE 200 mg/1 49348-260_e8434137-f58d-47e7-8849-e3264b01338d 49348-260 HUMAN OTC DRUG Sunmark Naproxen Sodium Naproxen Sodium TABLET ORAL 20030821 ANDA ANDA074661 McKesson NAPROXEN SODIUM 220 mg/1 49348-262_b31f9a7e-d5b3-489b-8595-ec4a4c6b75e4 49348-262 HUMAN OTC DRUG Senna laxative Natural vegetable laxative SENNOSIDES TABLET ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Mckesson (Sunmark) SENNOSIDES 8.6 mg/1 49348-263_d5518c63-5c7e-4acc-b40b-081e9ed2f898 49348-263 HUMAN OTC DRUG sunmark gas relief extra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20030821 OTC MONOGRAPH FINAL part332 McKesson DIMETHICONE 125 mg/1 49348-266_7f1c027b-76ff-4c5e-9cba-d36f2d85c3cd 49348-266 HUMAN OTC DRUG sunmark pain reliever Acetaminophen SUSPENSION ORAL 20030906 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL 49348-267_7058a2c6-be71-462b-bdaa-41ae94b512ca 49348-267 HUMAN OTC DRUG Sunmark Pain Reliever infants Acetaminophen SUSPENSION/ DROPS ORAL 20030818 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 80 mg/.8mL 49348-268_2f7cad2a-a3c7-4dcb-a860-e50ea632cb67 49348-268 HUMAN OTC DRUG Sunmark Pain Reliever Infants Acetaminophen SUSPENSION/ DROPS ORAL 20030919 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 80 mg/.8mL 49348-274_9a8897f4-132d-44d4-a3d8-483956e7b84a 49348-274 HUMAN OTC DRUG sunmark double antibiotic Bacitracin zinc and Polymyxin B sulfate OINTMENT TOPICAL 20120321 OTC MONOGRAPH FINAL part333B McKesson BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g 49348-276_677bff85-dad0-48d8-bf83-1c3d8303823d 49348-276 HUMAN OTC DRUG Sunmark Nasal Oxymetazoline HCl SPRAY NASAL 20030913 OTC MONOGRAPH FINAL part341 McKesson OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 49348-277_b5132a26-dc9f-4495-97fa-9225b87e1c8a 49348-277 HUMAN OTC DRUG SUNMARK ANTI DIARRHEAL Loperamide HCl SOLUTION ORAL 20030919 ANDA ANDA073243 McKesson LOPERAMIDE HYDROCHLORIDE 1 mg/5mL 49348-278_ea34b54e-00f9-4bb2-af13-7eebaa4c7934 49348-278 HUMAN OTC DRUG sunmark tussin chest congestion Guaifenesin SYRUP ORAL 20030703 OTC MONOGRAPH FINAL part341 McKesson GUAIFENESIN 100 mg/5mL 49348-279_261fdce9-7005-421a-a3f5-b92a8ff40cb4 49348-279 HUMAN OTC DRUG Sunmark Antifungal Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C McKesson CLOTRIMAZOLE 10 mg/g 49348-280_05990ba5-4433-477e-9ab0-d740a13b6479 49348-280 HUMAN OTC DRUG stool softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Mckesson (Sunmark) DOCUSATE CALCIUM 240 mg/1 49348-301_40f7d69c-a0c0-4779-a4f5-b232eb248f58 49348-301 HUMAN OTC DRUG sunmark lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120521 ANDA ANDA202319 McKesson LANSOPRAZOLE 15 mg/1 49348-302_0719c0f6-214b-49da-a82a-1c899fdb09a5 49348-302 HUMAN OTC DRUG SUNMARK ANTACID MAXIMUM STRENGTH CHERRY aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 20120601 OTC MONOGRAPH FINAL part331 McKesson ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 49348-305_d602d1ee-36c3-4ff8-a000-d63affe09d7e 49348-305 HUMAN OTC DRUG SUNMARK MILK OF MAGNESIA MINT magnesium hydroxide LIQUID ORAL 20120401 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM HYDROXIDE 1200 mg/15mL 49348-306_b6cc4a42-54c0-4fa7-bb4b-e4de842374e3 49348-306 HUMAN OTC DRUG Sunmark Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20030811 ANDA ANDA074661 McKesson NAPROXEN SODIUM 220 mg/1 49348-307_de2c0874-28c9-4cc2-9f70-e2875a844f1f 49348-307 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090416 OTC MONOGRAPH FINAL part333 Sunmark ISOPROPYL ALCOHOL 70 mL/100mL 49348-308_7f30a838-5456-4fa9-a0b8-4e885e90bd5d 49348-308 HUMAN OTC DRUG Wintergreen Isopropyl Alcohol Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20090409 OTC MONOGRAPH FINAL part333 Sunmark ISOPROPYL ALCOHOL 70 mL/100mL 49348-309_7d1b8782-b1b6-4dce-b8d7-76239b414d70 49348-309 HUMAN OTC DRUG sunmark pain reliever Acetaminophen LIQUID ORAL 20110926 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL 49348-314_7d220496-95c3-42ea-9f3b-220267bc673c 49348-314 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090416 OTC MONOGRAPH NOT FINAL part356 Sunmark HYDROGEN PEROXIDE 2.65 mL/100mL 49348-315_9bf7bbcb-c392-4d8f-aec2-cd54ea63f6cd 49348-315 HUMAN OTC DRUG Sunmark cough dm dextromethorphan polistirex SUSPENSION ORAL 20120828 ANDA ANDA091135 McKesson DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 49348-325_590b3b76-c395-431a-944b-3da669024050 49348-325 HUMAN OTC DRUG Sunmark pain and fever childrens Acetaminophen LIQUID ORAL 20130117 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL 49348-326_4e3feada-e5dd-42f1-823e-7fdf4d47c845 49348-326 HUMAN OTC DRUG sunmark Childrens Cetirizine Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 McKesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL 49348-329_043ea5ed-be47-4824-94ee-9b6004f079f7 49348-329 HUMAN OTC DRUG Sunmark Lubricating Plus carboxymethylcellulose sodium SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130606 OTC MONOGRAPH FINAL part349 McKesson CARBOXYMETHYLCELLULOSE SODIUM .5 g/100mL 49348-333_e5dc2f77-43a9-43b4-b6df-bf13c3f9f74a 49348-333 HUMAN OTC DRUG sunmark Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 McKesson LORATADINE 5 mg/5mL 49348-337_bf5b8a27-76f1-4ce0-9891-7f2cf751ed25 49348-337 HUMAN OTC DRUG Sunmark Caldiphen Calamine and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 McKesson PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 10; 80 mg/mL; mg/mL 49348-338_f10b8ebe-d71e-44dc-a18a-28e42dbf8eec 49348-338 HUMAN OTC DRUG sunmark stomach relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 20030913 OTC MONOGRAPH FINAL part335 McKesson BISMUTH SUBSALICYLATE 525 mg/15mL 49348-345_527d0234-8ed2-4d62-84df-f6f9d2eb0a65 49348-345 HUMAN OTC DRUG Sunmark Hemorrhoidal Cocoa butter, Phenylephrine HCl, Shark liver oil SUPPOSITORY RECTAL 20030913 OTC MONOGRAPH FINAL part346 McKesson COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2137.5; 75; 6.375 mg/1; mg/1; mg/1 49348-349_3c1b59e2-6967-4a7b-8b51-0116008b944c 49348-349 HUMAN OTC DRUG sunmark pain reliever pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20030811 OTC MONOGRAPH FINAL part338 McKesson ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 49348-354_fe1ff901-7ed2-40aa-94aa-a5fc62a740a2 49348-354 HUMAN OTC DRUG sunmark miconazole 3 Miconazole nitrate KIT 20030905 ANDA ANDA075329 McKesson 49348-355_e00db934-75b4-4044-913d-156e96fc142f 49348-355 HUMAN OTC DRUG sunmark miconazole 3 Miconazole nitrate KIT 20030905 ANDA ANDA075329 McKesson 49348-361_63c2388c-fc00-4789-b454-f8b59aa569c1 49348-361 HUMAN OTC DRUG Sunmark Sinus 12 hour Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030624 ANDA ANDA075153 McKesson PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 49348-362_517cc0aa-1a54-4a79-8dad-b554b13879bc 49348-362 HUMAN OTC DRUG Sunmark Calcium antacid extra strength Calcium carbonate TABLET, CHEWABLE ORAL 20030811 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 750 mg/1 49348-363_6ce8f2e2-382c-4759-84c9-14643367aa28 49348-363 HUMAN OTC DRUG Motion sickness less drowsy formula Meclizine HCl TABLET ORAL 20100709 OTC MONOGRAPH FINAL part336 McKesson (Sunmark) MECLIZINE HYDROCHLORIDE 25 mg/1 49348-364_18a65eb2-f8ff-48ea-b3c0-3b74fe81832c 49348-364 HUMAN OTC DRUG Urinary Pain Relief Phenazopyridine Hydrochloride TABLET ORAL 20100709 UNAPPROVED DRUG OTHER Mckesson (Sunmark) PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 49348-374_d32537f7-a288-441c-8bd3-8e97962f56fd 49348-374 HUMAN OTC DRUG sunmark ibuprofen infants ibuprofen SUSPENSION ORAL 20030828 ANDA ANDA075217 McKesson IBUPROFEN 50 mg/1.25mL 49348-375_471a56d6-c516-4514-b621-19fddc5c2c5a 49348-375 HUMAN OTC DRUG SunMark Allergy Relief Diphenhydramine Hydrochloride TABLET ORAL 20030821 OTC MONOGRAPH FINAL part341 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49348-379_72c65af4-b92d-454d-a3e3-ea22020331fc 49348-379 HUMAN OTC DRUG sunmark Clotrimazole 3 Clotrimazole CREAM VAGINAL 20000412 NDA NDA021143 McKesson CLOTRIMAZOLE 2 g/100g 49348-380_0253782e-04b0-43ee-97fb-b18eab67db33 49348-380 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090416 OTC MONOGRAPH FINAL part333 Sunmark ISOPROPYL ALCOHOL 91 mL/100mL 49348-387_ce8db400-4eb1-4520-97bf-635c787f6821 49348-387 HUMAN OTC DRUG sunmark pain reliever Acetaminophen LIQUID ORAL 20111025 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL 49348-389_66aefab9-b8cd-4498-a7ae-a10c1719e02e 49348-389 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Sunmark CETIRIZINE HYDROCHLORIDE 10 mg/1 49348-393_c09e8374-aa5c-4a0d-9073-58bf63a2e201 49348-393 HUMAN OTC DRUG Sunmark Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130815 ANDA ANDA076518 McKesson NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 49348-397_f36cb7e5-1a0d-4e2c-8f04-b3fe27e78db9 49348-397 HUMAN OTC DRUG sunmark sore throat Phenol SPRAY ORAL 20030914 OTC MONOGRAPH NOT FINAL part356 McKesson PHENOL 1.4 mL/100mL 49348-398_911b2293-abd6-4d7c-a1ea-6c6121235067 49348-398 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20090109 OTC MONOGRAPH FINAL part341 McKesson CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100kg; kg/100kg 49348-403_c6b37ca6-7ce3-45fb-9815-c2b3b176cb54 49348-403 HUMAN OTC DRUG Sunmark complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20121204 ANDA ANDA077355 McKesson CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 49348-405_6d6e8604-48ed-4775-91aa-52c1d255727d 49348-405 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20130121 OTC MONOGRAPH NOT FINAL part333A McKesson ALCOHOL 70 mL/100mL 49348-412_bf99d19d-ee93-437f-ab09-5e5d930fea7e 49348-412 HUMAN OTC DRUG Sunmark z sleep Diphenhydramine HCl SOLUTION ORAL 20130716 OTC MONOGRAPH FINAL part338 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 49348-413_65ce3602-3a03-4a07-9ce2-702555fcde0a 49348-413 HUMAN OTC DRUG Sunmark z-sleep Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140131 OTC MONOGRAPH FINAL part338 Mckesson DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49348-421_3a03b52a-5d9c-4732-962f-0dcdd7e5bd69 49348-421 HUMAN OTC DRUG Sunmark Adult Tussin DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20130813 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 49348-426_8b7ca96b-11b6-476a-a3c7-7e4e27a323bd 49348-426 HUMAN OTC DRUG Sunmark Muscle Rub Menthol, Methyl salicylate CREAM TOPICAL 20131103 OTC MONOGRAPH NOT FINAL part348 McKesson MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g 49348-430_83acab73-3efb-4ea6-ad03-31b82dd017b9 49348-430 HUMAN OTC DRUG Sunmark Infants Pain and Fever Acetaminophen LIQUID ORAL 20110926 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL 49348-431_7fd0a555-4930-45e0-ba0b-059661eaab4a 49348-431 HUMAN OTC DRUG Sunmark ibuprofen cold and sinus Ibuprofen, Pseudoephedrine Hydrochloride TABLET ORAL 20030828 ANDA ANDA074567 McKesson IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 49348-441_1d0959e7-9d66-4ec2-aa39-6686aec42203 49348-441 HUMAN OTC DRUG sunmark Hydrocortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 McKesson HYDROCORTISONE 1 g/100g 49348-442_797a9115-7fa6-4f3f-8bc3-1d7515cf0207 49348-442 HUMAN OTC DRUG Sunmark Acid Reducer Famotidine TABLET, COATED ORAL 20030811 ANDA ANDA075312 McKesson FAMOTIDINE 10 mg/1 49348-443_28e32dd2-f68b-4eb8-ba99-b560f6413308 49348-443 HUMAN OTC DRUG Sunmark Lice Killing Maximum Strength Lice Treatment Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070727 OTC MONOGRAPH FINAL part358G McKesson PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 49348-459_73c0301c-5ca8-492c-8a25-5016f355b4b6 49348-459 HUMAN OTC DRUG Hygienic Cleansing Pads witch hazel SOLUTION TOPICAL 20030618 OTC MONOGRAPH FINAL part346 McKesson WITCH HAZEL .5 mL/mL 49348-460_c75be292-67e6-49d6-b90c-58d123760f54 49348-460 HUMAN OTC DRUG Lice Treatment permethrin LOTION TOPICAL 20000328 ANDA ANDA075014 McKesson PERMETHRIN 1 mg/100mL 49348-471_10139ffb-33f1-47e4-999a-a2162066d4b3 49348-471 HUMAN OTC DRUG SunMark Night Time Sleep Aid Diphenhydramine Hydrochloride TABLET ORAL 20030821 OTC MONOGRAPH FINAL part338 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49348-472_21d10d35-ac5f-4ff2-827f-3775944b507a 49348-472 HUMAN OTC DRUG Sunmark no drip Oxymetazoline HCl SPRAY NASAL 20030919 OTC MONOGRAPH FINAL part341 McKesson OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 49348-473_7b32dc8d-59e9-4772-8f66-7b22a7b73688 49348-473 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130920 ANDA ANDA201745 Sunmark RANITIDINE HYDROCHLORIDE 75 mg/1 49348-476_80af95e8-a78b-4291-9163-9e63e58f6112 49348-476 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol MOUTHWASH ORAL 19950825 OTC MONOGRAPH NOT FINAL part348 McKesson EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 49348-477_37555bb0-8080-486b-8029-ceca0142f607 49348-477 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20121217 OTC MONOGRAPH NOT FINAL part333A McKesson ALCOHOL 700 mg/mL 49348-480_2d9b8bc2-7f12-424f-a39f-2e13eef66504 49348-480 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090416 OTC MONOGRAPH FINAL part333 Sunmark ISOPROPYL ALCOHOL 91 mL/100mL 49348-482_47582d82-533e-4563-83e0-babcfbe12693 49348-482 HUMAN OTC DRUG Antiseptic EUCALYPTOL,MENTHOL, METHYL SALICYLATE, THYMOL RINSE ORAL 19900815 OTC MONOGRAPH NOT FINAL part356 McKesson EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 49348-483_20d58c23-8eda-486d-b3d0-e6dd5a6989d1 49348-483 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130815 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) DOCUSATE SODIUM 100 mg/1 49348-487_4605a235-a22e-40d1-8f6e-00c361e92904 49348-487 HUMAN OTC DRUG sunmark lice solution kit Piperonyl Butoxide, Pyrethrum Extract KIT 20071019 OTC MONOGRAPH FINAL part358G McKesson 49348-489_d71d8a53-4bf0-42d5-9040-a5042f2dbf9c 49348-489 HUMAN OTC DRUG gas relief ultra strength Simethicone CAPSULE ORAL 20100709 OTC MONOGRAPH FINAL part332 McKesson (Sunmark) DIMETHICONE 180 mg/1 49348-498_850d330e-87ba-47e4-89b4-76af533545a4 49348-498 HUMAN OTC DRUG Sunmark aspirin adult low strength Aspirin TABLET, CHEWABLE ORAL 20030919 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 49348-499_62f2f2dc-a5d2-4cdd-816a-b7a48eab9c5f 49348-499 HUMAN OTC DRUG Sunmark ibuprofen childrens Ibuprofen SUSPENSION ORAL 20030906 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL 49348-500_6e1a0454-f229-4df1-89b2-979936bbaba2 49348-500 HUMAN OTC DRUG Sunmark ibuprofen childrens Ibuprofen SUSPENSION ORAL 20030624 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL 49348-504_bf973378-81ce-40c1-b0f6-494b7ba479b1 49348-504 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20020301 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM CITRATE 1.745 g/29.6mL 49348-506_ca87c954-ed1f-4611-b38a-ed183e3f8c20 49348-506 HUMAN OTC DRUG Sunmark migraine relief Acetaminophen, Aspirin, Caffeine TABLET ORAL 20030818 ANDA ANDA075794 McKesson ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 49348-508_adf8532d-e0ef-4623-8a1e-0a51c37d77c2 49348-508 HUMAN OTC DRUG SUNMARK TIOCONAZOLE 1 Tioconazole OINTMENT VAGINAL 20071218 ANDA ANDA075915 McKesson TIOCONAZOLE 6.5 g/100g 49348-509_f99a3bd4-7fe1-4c4e-8532-b29e9ebb2156 49348-509 HUMAN OTC DRUG Sunmark Gas relief Dimethicone TABLET, CHEWABLE ORAL 20040410 OTC MONOGRAPH FINAL part332 McKesson DIMETHICONE 80 mg/1 49348-511_c3ad9e18-4bc2-4f52-b762-36f60c7d6cca 49348-511 HUMAN OTC DRUG Stomach relief Bismuth subsalicylate TABLET ORAL 20110909 OTC MONOGRAPH FINAL part335 McKesson BISMUTH SUBSALICYLATE 262 mg/1 49348-520_0e921767-7cbf-4739-895c-29567fbcb357 49348-520 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H McKesson PYRITHIONE ZINC 10 mg/mL 49348-521_f4e86652-6179-4aef-bd2c-179419bf4183 49348-521 HUMAN OTC DRUG Sunmark Hydrocortisone with Aloe Maximum Strength Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 McKesson HYDROCORTISONE 1 g/100g 49348-522_7f8d90f1-5da5-4307-bce4-487cc80fe71d 49348-522 HUMAN OTC DRUG sunmark Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 McKesson HYDROCORTISONE 1 g/100g 49348-524_45957018-6d31-4bad-8cd5-31ca2cec1528 49348-524 HUMAN OTC DRUG Sunmark Nasal Fast Relief Phenylephrine hydrochloride SPRAY NASAL 20030919 OTC MONOGRAPH FINAL part341 McKesson PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 49348-527_dd569439-86ee-4d15-a612-21054333e430 49348-527 HUMAN OTC DRUG sunmark enema Saline ENEMA RECTAL 20091118 OTC MONOGRAPH NOT FINAL part334 McKesson SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 49348-529_e374d313-79db-44ee-9a15-f87daae0f7f1 49348-529 HUMAN OTC DRUG sunmark anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030627 ANDA ANDA075232 McKesson LOPERAMIDE HYDROCHLORIDE 2 mg/1 49348-530_8191186c-ba90-4c35-b40c-2944c2f49ee7 49348-530 HUMAN OTC DRUG Sunmark Miconazole 7 Miconazole nitrate CREAM VAGINAL 20030731 ANDA ANDA074760 McKesson MICONAZOLE NITRATE 2 g/100g 49348-532_529b01d5-09b0-476a-8c06-4762dce00c12 49348-532 HUMAN OTC DRUG natural laxative plus stool softener docusate sodium and sennosides TABLET ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Mckesson (Sunmark) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 49348-540_da6d8aad-0d94-43eb-b88d-9b3934a44bce 49348-540 HUMAN OTC DRUG sunmark nite time cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20030703 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 6.25 mg/15mL; mg/15mL 49348-541_60d0d9f4-45c6-4861-8423-d5cc7a755144 49348-541 HUMAN OTC DRUG Sunmark fiber laxative Methylcellulose TABLET ORAL 20070102 OTC MONOGRAPH FINAL part334 McKesson METHYLCELLULOSE (4000 CPS) 500 mg/1 49348-543_000c5c1b-d378-4acb-af47-5414dcab8b70 49348-543 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Sunmark LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 49348-544_50737cb7-6884-4960-a0bf-89188bedd322 49348-544 HUMAN OTC DRUG Stool Softener plus stimulant Laxative Docusate sodium and Sennosides TABLET ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Mckesson (Sunmark) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 49348-553_0b7d61f9-d498-45e2-9f8a-4033937e24cc 49348-553 HUMAN OTC DRUG Sunmark enema mineral oil Mineral Oil LIQUID RECTAL 20091118 OTC MONOGRAPH NOT FINAL part334 McKesson MINERAL OIL 100 mL/100mL 49348-559_056ac079-32ec-4558-a8e2-10617b8e39cd 49348-559 HUMAN OTC DRUG Medicated Wipes witch hazel SOLUTION TOPICAL 20030619 OTC MONOGRAPH FINAL part346 McKesson WITCH HAZEL .5 mL/mL 49348-561_91129b43-c633-48d0-93d2-882b5e1d9ee2 49348-561 HUMAN OTC DRUG SUNMARK CALCIUM ANTACID Calcium carbonate TABLET, CHEWABLE ORAL 20030919 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 750 mg/1 49348-568_fe80bf8c-8ba4-43e8-b1ff-60a1bb8cade0 49348-568 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100709 ANDA ANDA078682 Mckesson (Sunmark) IBUPROFEN 200 mg/1 49348-572_71060267-6d9c-46d9-8323-6c738da887c4 49348-572 HUMAN OTC DRUG Sunmark Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050618 ANDA ANDA076789 McKesson NICOTINE 4 mg/1 49348-573_2bb76f73-6a49-499d-92ba-c90550ef665a 49348-573 HUMAN OTC DRUG sunmark nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050618 ANDA ANDA076775 McKesson NICOTINE 2 mg/1 49348-574_6225b637-253e-45f8-9ba2-4b81e738ac92 49348-574 HUMAN OTC DRUG Sunmark sleep aid Doxylamine succinate TABLET ORAL 20030815 ANDA ANDA040167 McKesson DOXYLAMINE SUCCINATE 25 mg/1 49348-576_f43757ee-85b7-413f-ad49-0650270d6808 49348-576 HUMAN OTC DRUG sunmark anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 20031007 UNAPPROVED DRUG OTHER Mckesson DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 49348-577_44bfb19c-57f6-46cc-b9b9-9b007dab6722 49348-577 HUMAN OTC DRUG Sunmark infants gas relief drops Simethicone EMULSION ORAL 20031031 OTC MONOGRAPH FINAL part332 McKesson DIMETHICONE 20 mg/.3mL 49348-598_82c6ecbf-31e4-4029-9d12-1342b602f99c 49348-598 HUMAN OTC DRUG Bisacodyl Laxative bisacodyl SUPPOSITORY RECTAL 20050808 OTC MONOGRAPH FINAL part334 McKesson BISACODYL 10 mg/1 49348-599_93b9892a-eb53-45d1-9e30-cb99485c998e 49348-599 HUMAN OTC DRUG Gentle Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20130110 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) BISACODYL 5 mg/1 49348-600_78121745-fe0c-4277-9e1f-520beb179c78 49348-600 HUMAN OTC DRUG sunmark triple antibiotic plus pain relief polymyxin B sulfate, bacitracin zinc, neomycin sulfate, and pramoxine hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B McKesson BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g 49348-602_9578d857-ba01-487c-bfa7-adc795c11659 49348-602 HUMAN OTC DRUG Anti-Dandruff Coal Tar SHAMPOO TOPICAL 20050521 OTC MONOGRAPH FINAL part358H McKesson COAL TAR 2.5 mL/100L 49348-603_51c2bd90-0725-4186-8821-2e504deeeebb 49348-603 HUMAN OTC DRUG Anticavity SODIUM FLUORIDE RINSE ORAL 20010817 OTC MONOGRAPH FINAL part355 McKesson SODIUM FLUORIDE .05 kg/100L 49348-610_514c2dd6-a0eb-4265-95da-ad30adabb2bc 49348-610 HUMAN OTC DRUG Sunmark Caldyphen Clear Zinc Acetate and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 McKesson PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 10; 80 mg/mL; mg/mL 49348-616_32e8158b-51f5-48bd-9058-3c49f9af23a4 49348-616 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Mckesson (Sunmark) DOCUSATE SODIUM 100 mg/1 49348-622_abbac463-435c-4dc2-9623-6cc1dc3a6339 49348-622 HUMAN OTC DRUG sunmark Povidone-Iodine Topical POVIDONE-IODINE SOLUTION TOPICAL 20120628 OTC MONOGRAPH FINAL part333A McKesson POVIDONE-IODINE 100 mg/mL 49348-632_98d0f85c-b530-46b9-bd32-4becd65eebbe 49348-632 HUMAN OTC DRUG Sunmark smooth antacid Calcium carbonate TABLET, CHEWABLE ORAL 20040426 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 750 mg/1 49348-633_ce441faa-49d4-45fb-a13d-ea6396db77c8 49348-633 HUMAN OTC DRUG Fiber laxative Psyllium husk CAPSULE ORAL 20031114 OTC MONOGRAPH NOT FINAL part334 McKesson PSYLLIUM HUSK 520 mg/1 49348-634_24081205-4ff0-40a8-b554-2f2f7c1a3000 49348-634 HUMAN OTC DRUG Sunmark Loratadine allergy relief Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20040202 ANDA ANDA075990 McKesson LORATADINE 10 mg/1 49348-636_285e79a3-f79a-42e3-8462-ccbbe6f6ea65 49348-636 HUMAN OTC DRUG Sunmark childrens loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 McKesson LORATADINE 5 mg/5mL 49348-637_8cb634b5-52bf-444a-baf5-740467091008 49348-637 HUMAN OTC DRUG SUNMARK ALLERGY RELIEF Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20040202 ANDA ANDA075990 McKesson LORATADINE 10 mg/1 49348-639_107a79ca-1917-48d2-9e7d-b87ab4bade17 49348-639 HUMAN OTC DRUG Sunmark Ibuprofen IB Ibuprofen TABLET, CHEWABLE ORAL 20040710 ANDA ANDA076359 McKesson IBUPROFEN 100 mg/1 49348-642_c0314677-1947-4acb-ad84-90b520a40b0e 49348-642 HUMAN OTC DRUG sunmark ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20040429 ANDA ANDA075217 McKesson IBUPROFEN 50 mg/1.25mL 49348-645_d44c173a-0821-4723-95ce-2daa30a8a684 49348-645 HUMAN OTC DRUG sunmark miconazole 3 Miconazole nitrate KIT 20040720 ANDA ANDA076357 McKesson 49348-653_40570ec8-e03a-4a9c-8f56-688107f7b35e 49348-653 HUMAN OTC DRUG sunmark aspirin adult low strength Aspirin TABLET, FILM COATED ORAL 20040923 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 49348-680_25b4937d-15b1-42b0-ba9d-8a0e11a8a219 49348-680 HUMAN OTC DRUG Sunmark Milk of Magnesia saline laxative Magnesium hydroxide LIQUID ORAL 20050211 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM HYDROXIDE 1200 mg/15mL 49348-682_0c8e76de-c19a-4d90-9b2d-21381f8744f1 49348-682 HUMAN OTC DRUG Sunmark athletes foot powder Tolnaftate SPRAY TOPICAL 20050616 OTC MONOGRAPH FINAL part333C McKesson TOLNAFTATE 1 g/100g 49348-683_311e814b-b4a9-4969-94ed-c1702bb83060 49348-683 HUMAN OTC DRUG Sunmark athletes foot liquid spray tolnaftate SPRAY TOPICAL 20050616 OTC MONOGRAPH NOT FINAL part333 McKesson TOLNAFTATE 1 g/100g 49348-686_539e2c02-b258-45ea-8694-58ce5165ea7c 49348-686 HUMAN OTC DRUG SUNMARK 12 HOUR ALLERGY RELIEF Clemastine fumarate TABLET ORAL 20030703 ANDA ANDA074512 McKesson CLEMASTINE FUMARATE 1.34 mg/1 49348-687_d0026868-1b2c-49c3-b5ef-7c6a1bda3ba2 49348-687 HUMAN OTC DRUG SUNMARK MILK OF MAGNESIA Magnesium hydroxide LIQUID ORAL 20030821 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM HYDROXIDE 1200 mg/15mL 49348-688_68b64ef2-b4c7-4697-845e-fe97f166ce1d 49348-688 HUMAN OTC DRUG sunmark milk of magnesia Magnesium hydroxide LIQUID ORAL 20030821 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM HYDROXIDE 1200 mg/15mL 49348-689_0155e13e-82d1-4620-85ef-ecd4aa925e41 49348-689 HUMAN OTC DRUG sunmark antifungal Miconazole Nitrate CREAM TOPICAL 19911001 OTC MONOGRAPH FINAL part333C McKesson MICONAZOLE NITRATE 20 mg/g 49348-690_a85c4659-1d93-4c17-80be-6d613c8fc69a 49348-690 HUMAN OTC DRUG sunmark antibiotic plus pain relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B McKesson NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g 49348-691_1e39507d-c809-4840-b817-c188e06ad142 49348-691 HUMAN OTC DRUG Sunmark Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050623 ANDA ANDA078325 McKesson NICOTINE 2 mg/1 49348-692_99a32f89-50ca-4970-a815-087a25f8fbe9 49348-692 HUMAN OTC DRUG Sunmark Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050623 ANDA ANDA078326 McKesson NICOTINE 4 mg/1 49348-696_2da588a0-d07c-4d22-ab3b-c21dc1874c8e 49348-696 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20120320 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM CITRATE 1.745 g/29.6mL 49348-700_140dec71-7933-4d38-870a-9233061222c8 49348-700 HUMAN OTC DRUG sunmark nasal decongestant pe maximum strength Phenylephrine Hydrochloride TABLET ORAL 20050214 OTC MONOGRAPH FINAL part341 McKesson PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 49348-702_b85b2cde-7a8a-4ca5-87ab-4524cc4c692a 49348-702 HUMAN OTC DRUG Sunmark Pain Reliever extra strength Acetaminophen TABLET, COATED ORAL 20050518 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 49348-704_ee25fbe5-8c0d-455f-9c68-07eea277156a 49348-704 HUMAN OTC DRUG sunmark arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080213 ANDA ANDA075077 McKesson ACETAMINOPHEN 650 mg/1 49348-705_2bcb711c-7ac0-4f32-a5e5-b7e802c8a666 49348-705 HUMAN OTC DRUG Sunmark 8 hour pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050830 ANDA ANDA075077 McKesson ACETAMINOPHEN 650 mg/1 49348-706_acb832a8-9e8e-4572-b181-c6775fe93e09 49348-706 HUMAN OTC DRUG sunmark ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20030624 ANDA ANDA072096 McKesson IBUPROFEN 200 mg/1 49348-709_73b0825f-fe9b-43fb-b1ed-7ce95b33e0e0 49348-709 HUMAN OTC DRUG pain reliever extra strength Acetaminophen CAPSULE, LIQUID FILLED ORAL 20100709 OTC MONOGRAPH NOT FINAL part343 Mckesson (Sunmark) ACETAMINOPHEN 500 mg/1 49348-711_7cdd5f19-5da7-4955-97fe-2e4e8a22f004 49348-711 HUMAN OTC DRUG Sunmark Iodides Tincture Ethyl Alcohol LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A McKesson ALCOHOL .45 mL/mL 49348-714_49cdb4b9-d20c-49ab-8348-fb4b373253ca 49348-714 HUMAN OTC DRUG STOOL SOFTENER EXTRA STRENGTH DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Mckesson (Sunmark) DOCUSATE SODIUM 250 mg/1 49348-715_4016750e-659a-4955-81cf-2c994107db7f 49348-715 HUMAN OTC DRUG sunmark cold and allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20060922 OTC MONOGRAPH FINAL part341 McKesson CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 49348-716_97cd9379-fa4a-4fc6-baaf-e15a0791bf4b 49348-716 HUMAN OTC DRUG sunmark sinus and allergy pe maximum strength Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20060925 OTC MONOGRAPH FINAL part341 McKesson CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 49348-720_ce4462fd-0f09-4e27-965d-6c8d78690dc3 49348-720 HUMAN OTC DRUG sunmark hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 20030919 OTC MONOGRAPH FINAL part346 McKesson MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 49348-722_c78c300d-7bf9-432c-8fb2-06e61e74f89e 49348-722 HUMAN OTC DRUG sunmark headache relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20030913 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 49348-727_fbb21f97-a506-4282-a403-1fa836c749e1 49348-727 HUMAN OTC DRUG sunmark ibuprofen ib Ibuprofen TABLET, FILM COATED ORAL 20060428 ANDA ANDA077349 McKesson IBUPROFEN 200 mg/1 49348-728_909de6c3-2371-47e5-927d-20afc57e89a0 49348-728 HUMAN OTC DRUG Sunmark Chest Congestion Relief DM DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 49348-729_3f6499ed-2286-461a-8532-3577f5165ba9 49348-729 HUMAN OTC DRUG Chest Congestion Relief Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Mckesson GUAIFENESIN 400 mg/1 49348-730_604aa6ea-76e0-4ac3-9af1-4682a0dabf88 49348-730 HUMAN OTC DRUG Sunmark Pain Reliever Acetaminophen TABLET, COATED ORAL 20051227 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 49348-733_df6632a1-3908-4de3-94e7-b96c1a8c2f1a 49348-733 HUMAN OTC DRUG Sunmark acid reducer Ranitidine TABLET ORAL 20090710 ANDA ANDA076760 McKesson RANITIDINE HYDROCHLORIDE 75 mg/1 49348-737_edfe3e75-f63c-4b5c-9604-ccc509fa18c9 49348-737 HUMAN OTC DRUG SUNMARK TUSSIN CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20060502 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 49348-738_1abb2c29-b55b-43b2-8aea-f26182ee6cf6 49348-738 HUMAN OTC DRUG Day Time PE cold and flu relief ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl CAPSULE, LIQUID FILLED ORAL 20100709 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 49348-740_1e9f8701-44c2-40dc-aee5-c5f5f3210595 49348-740 HUMAN OTC DRUG gas relief drops infants simethicone EMULSION ORAL 20121201 OTC MONOGRAPH FINAL part332 Mckesson DIMETHICONE 20 mg/.3mL 49348-741_57db4fbe-5121-4d7d-be68-12b20e0c0fd6 49348-741 HUMAN OTC DRUG Nite time cold and flu relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20120718 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 49348-742_36a57965-23db-4997-849b-c561edd0ac09 49348-742 HUMAN OTC DRUG Sunmark nite time cold and flu acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20060428 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 49348-743_709fd6a0-4485-443d-a6b4-f5dc4ddadfd3 49348-743 HUMAN OTC DRUG McKesson Nite Time acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090709 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 49348-744_42959183-19d4-497f-93b1-c503a8381a56 49348-744 HUMAN OTC DRUG Sunmark Antacid Maximum Strength Aluminum Hydroxide, Magnesium Hydroxide, Simethicone LIQUID ORAL 20060501 OTC MONOGRAPH FINAL part332 McKesson ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 49348-752_be0d3adc-77bb-47ad-bd8c-771139667340 49348-752 HUMAN OTC DRUG Anti-Diarrheal loperamide HCl LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100709 NDA NDA021855 Mckesson (Sunmark) LOPERAMIDE HYDROCHLORIDE 2 mg/1 49348-753_9bb8dc8a-b1ab-49bb-a41c-09699fc60d1d 49348-753 HUMAN OTC DRUG Sunmark Day time cold and flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20060609 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 49348-756_253e5ced-7c45-4c31-8d1c-49cbbbfcf31f 49348-756 HUMAN OTC DRUG Sunmark aspirin low dose Aspirin TABLET, DELAYED RELEASE ORAL 20030811 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 49348-757_bd0f0376-0a8f-4b47-94f7-01d0590a1b53 49348-757 HUMAN OTC DRUG Sunmark Aspirin Aspirin TABLET, CHEWABLE ORAL 20030821 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 49348-759_3b0b735c-59e0-40f2-a574-e92cebeb6a15 49348-759 HUMAN OTC DRUG Sunmark fiber laxative Calcium polycarbophil TABLET, FILM COATED ORAL 20030922 OTC MONOGRAPH NOT FINAL part334 McKesson CALCIUM POLYCARBOPHIL 625 mg/1 49348-771_2610fe9f-c360-4876-b96e-50ae3a81d15d 49348-771 HUMAN OTC DRUG Sunmark stay awake Caffeine TABLET ORAL 20030821 OTC MONOGRAPH FINAL part340 McKesson CAFFEINE 200 mg/1 49348-774_e2c69896-9616-45ad-904a-318909928664 49348-774 HUMAN OTC DRUG Sunmark Chest Congestion Relief PE PE Guaifenesin/phenylephrine TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 Mckesson Corporation GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 49348-775_46723e5a-bf0e-41d3-bd64-448ae44a924c 49348-775 HUMAN OTC DRUG SUNMARK COLD AND COUGH DM CHILDRENS Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20060911 OTC MONOGRAPH FINAL part343 McKesson BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 49348-776_920ebccd-c5a0-49d5-9024-0f14d2219f44 49348-776 HUMAN OTC DRUG Sunmark sinus congestion and pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20061221 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 49348-777_0e762c6c-a1ce-4889-b10b-a2b4e44487eb 49348-777 HUMAN OTC DRUG Sunmark Cold and Allergy Childrens phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20060911 OTC MONOGRAPH FINAL part341 McKesson BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 49348-778_ef414c05-e257-4e5e-8d4e-77b91d35c666 49348-778 HUMAN OTC DRUG sunmark allergy multi symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20051206 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 49348-787_a4b6e1ac-7dd0-42cb-b635-198303b68b0c 49348-787 HUMAN OTC DRUG Sunmark Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061221 ANDA ANDA076777 McKesson NICOTINE 2 mg/1 49348-788_c3ba82a4-2261-4ec6-bba4-5faebe4bd906 49348-788 HUMAN OTC DRUG Sunmark Nicotine Nicotine GUM, CHEWING ORAL 20061221 ANDA ANDA076779 McKesson NICOTINE 4 mg/1 49348-790_5ffb32df-6b19-436e-ac92-0a0ab5b6f550 49348-790 HUMAN OTC DRUG Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 McKesson TERBINAFINE HYDROCHLORIDE 1 g/100g 49348-791_280c77e4-a5bd-46c1-bd93-a58f5fba4d39 49348-791 HUMAN OTC DRUG Sunmark Cold Head Congestion Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070720 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 49348-793_430f18b7-1b1c-44c5-a346-be4665430e82 49348-793 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 19930719 ANDA ANDA074165 McKesson CLOTRIMAZOLE 10 mg/g 49348-797_63fc36c2-9699-40f7-a11d-1c65250f662f 49348-797 HUMAN OTC DRUG sunmark pain reliever Acetaminophen SUSPENSION ORAL 20030821 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL 49348-799_a101cfad-fa2e-4bd4-8cee-d66e3d3e5438 49348-799 HUMAN OTC DRUG Sunmark Hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20080204 OTC MONOGRAPH FINAL part346 McKesson GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g 49348-801_d906e423-1437-4198-884a-5b31752a6381 49348-801 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part348 McKesson MENTHOL 1.5 mg/g 49348-802_722f07c5-109b-4221-9614-bdd55ec44309 49348-802 HUMAN OTC DRUG Sunmark Phenolated Calamine Calamine and Zinc Oxide and Phenol LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 McKesson PHENOL; ZINC OXIDE 10; 160 mg/mL; mg/mL 49348-804_e660582c-3688-411d-b23b-483e55c0765c 49348-804 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20090929 OTC MONOGRAPH NOT FINAL part334 Sunmark MINERAL OIL 15 mg/15mg 49348-805_b28763b8-cd37-4b52-9958-c43d79646e85 49348-805 HUMAN OTC DRUG Witch Hazel Witch Hazel OIL ORAL; TOPICAL 20090416 OTC MONOGRAPH FINAL part346 Sunmark WITCH HAZEL 86 mL/100mL 49348-811_33943cff-4aa0-43c0-8787-a08130b8a4d0 49348-811 HUMAN OTC DRUG Hemorrhoidal Cooling Gel phenylephrine and witch hazel GEL TOPICAL 20061115 OTC MONOGRAPH FINAL part346 McKesson PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/g; g/g 49348-813_ec1985ab-a2c5-433b-9acc-de7a3cdb0365 49348-813 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20061128 OTC MONOGRAPH NOT FINAL part333A McKesson BENZALKONIUM CHLORIDE .13 mL/mL 49348-817_ccd0ebe2-2e48-4284-aa71-d91dce955e88 49348-817 HUMAN OTC DRUG SunMark Acid Reducer maximum strength Famotidine TABLET ORAL 20070618 ANDA ANDA077351 McKesson FAMOTIDINE 20 mg/1 49348-818_d51883ce-73e9-4d89-ba9b-0fd0c5b548fd 49348-818 HUMAN OTC DRUG Sunmark Loratadine Loratadine TABLET ORAL 20070621 ANDA ANDA076301 McKesson LORATADINE 10 mg/1 49348-819_41d34290-b6d5-42e8-814d-0723e84228fb 49348-819 HUMAN OTC DRUG sunmark all day relief Naproxen Sodium TABLET, FILM COATED ORAL 20030811 ANDA ANDA074661 McKesson NAPROXEN SODIUM 220 mg/1 49348-820_fd9e46bb-4087-4ee8-a6d2-bf081114e311 49348-820 HUMAN OTC DRUG sunmark all day relief Naproxen Sodium TABLET ORAL 20030821 ANDA ANDA074661 McKesson NAPROXEN SODIUM 220 mg/1 49348-828_b1b7ceca-c23a-4a25-a09b-077d7cae2e43 49348-828 HUMAN OTC DRUG Sun Mark Mucus Relief Cough Childrens Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20071012 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 49348-833_abb2d007-1d4d-4e53-8c36-c84453c8cb42 49348-833 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate SUPPOSITORY VAGINAL 20111209 ANDA ANDA073507 McKesson MICONAZOLE NITRATE 100 mg/1 49348-834_af235554-f943-4e69-9557-6880cc6168f7 49348-834 HUMAN OTC DRUG Medicated Body MENTHOL, ZINC OXIDE POWDER TOPICAL 19940618 OTC MONOGRAPH NOT FINAL part348 McKesson MENTHOL; ZINC OXIDE .15; 1 g/100kg; g/100kg 49348-840_6c0e25c1-2bfc-4ac2-ac9f-18f088d29741 49348-840 HUMAN OTC DRUG Sunmark cold head congestion Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20080319 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 49348-841_f89fe516-dfe5-41c1-aea0-f8ca40a13827 49348-841 HUMAN OTC DRUG sunmark day time cold and cough childrens triacting formula Dextromethorphan HBr, Phenylephrine HCl SYRUP ORAL 20080331 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 49348-843_0fa13bf6-b6ba-471d-a75f-b598a8c4ed94 49348-843 HUMAN OTC DRUG SunMark All Day Allergy Childrens cetirizine hydrochloride LIQUID ORAL 20080423 ANDA ANDA090254 McKesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL 49348-845_f225c4c5-b99c-42ec-bfcb-9c2d4ae8be96 49348-845 HUMAN OTC DRUG sunmark nite time d cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID ORAL 20030824 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 500; 15; 6.25; 30 mg/15mL; mg/15mL; mg/15mL; mg/15mL 49348-846_03b61c7f-33bc-4caa-a899-dca7601ea21b 49348-846 HUMAN OTC DRUG sunmark omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080226 NDA NDA022032 McKesson OMEPRAZOLE 20 mg/1 49348-847_d4d54c37-b807-4896-8cd7-cfcd16a2867e 49348-847 HUMAN OTC DRUG SunMark All day allergy Cetirizine Hydrochloride TABLET ORAL 20080121 ANDA ANDA078336 McKesson CETIRIZINE HYDROCHLORIDE 10 mg/1 49348-849_492e6c04-e1a4-41a4-9090-bfe010609c90 49348-849 HUMAN OTC DRUG Sunmark childrens loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 McKesson LORATADINE 5 mg/5mL 49348-850_183d7f6f-c1ab-45b7-b9a3-f9c0ddf67bcc 49348-850 HUMAN OTC DRUG Sunmark Acid Reducer Maximum Strength Ranitidine TABLET ORAL 20080213 ANDA ANDA078653 McKesson RANITIDINE HYDROCHLORIDE 150 mg/1 49348-851_0cabdccd-5d24-40fe-a004-5ad4b5379718 49348-851 HUMAN OTC DRUG Sunmark All Day Allergy D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080418 ANDA ANDA077170 McKesson CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 49348-852_7887e8f1-9bf7-4f9c-a8c5-c1d0660d40fe 49348-852 HUMAN OTC DRUG Sunmark Nicotine Nicotine Polacrilex LOZENGE ORAL 20080507 ANDA ANDA077007 McKesson NICOTINE 2 mg/1 49348-853_e78085be-7775-4bab-acf0-eb437e126f0f 49348-853 HUMAN OTC DRUG Sunmark Nicotine Nicotine Polacrilex LOZENGE ORAL 20080430 ANDA ANDA077007 McKesson NICOTINE 4 mg/1 49348-854_5d4a1e9f-ce43-47ce-8fa8-52a45bdb3b46 49348-854 HUMAN OTC DRUG sunmark anti-itch diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20050920 OTC MONOGRAPH FINAL part348 McKesson DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g 49348-855_d89bbbd0-efb8-4b68-bd27-bf7ce0a6f104 49348-855 HUMAN OTC DRUG sunmark tension headache Acetaminophen, Caffeine TABLET, FILM COATED ORAL 20080725 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 49348-861_9c830aac-3d12-47eb-8ec7-a9f2d7a32c5d 49348-861 HUMAN OTC DRUG sunmark tussin dm sugar free Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20030624 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 49348-863_fff9a801-cc0f-424b-b237-6ecf84833bd7 49348-863 HUMAN OTC DRUG gas relief simethicone TABLET, CHEWABLE ORAL 20121001 OTC MONOGRAPH FINAL part332 Mckesson DIMETHICONE 125 mg/1 49348-864_edc8d94a-293d-4a69-9c10-30edbe6aa50f 49348-864 HUMAN OTC DRUG Sunmark Saline Laxative ENEMA RECTAL 20130306 OTC MONOGRAPH NOT FINAL part334 Mckesson Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 49348-865_0fa12835-3d1c-4176-9135-25a9babae130 49348-865 HUMAN OTC DRUG Sunmark Calcium Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20031027 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 750 mg/1 49348-872_39cd7100-b91b-44c3-9154-e69ad7df2666 49348-872 HUMAN OTC DRUG sunmark miconazole 7 Miconazole nitrate CREAM VAGINAL 20031125 ANDA ANDA074760 McKesson MICONAZOLE NITRATE 2 g/100g 49348-873_527cf751-8715-48ca-a2c6-f1b13b0d1585 49348-873 HUMAN OTC DRUG sunmark ibuprofen pm diphenhydramine citrate and ibuprofen TABLET, COATED ORAL 20090218 ANDA ANDA079113 McKesson DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 49348-876_63444bd4-45bc-4acf-9492-b1040dd529af 49348-876 HUMAN OTC DRUG Sunmark ibuprofen childrens Ibuprofen LIQUID ORAL 20090401 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL 49348-879_22173bd8-4b22-4d05-bf82-a3aa9ce13d62 49348-879 HUMAN OTC DRUG sunmark Cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20090401 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 49348-880_a497ef2c-a9cd-42ec-b70d-7cc5b125c7f1 49348-880 HUMAN OTC DRUG Sunmark Enema Mineral Oil ENEMA RECTAL 20130801 OTC MONOGRAPH NOT FINAL part334 Mckesson Corporation MINERAL OIL 113.115 g/118mL 49348-882_1a3f8f96-4fdd-4411-b396-0916973dad3b 49348-882 HUMAN OTC DRUG Sunmark muscle rub Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20090610 OTC MONOGRAPH NOT FINAL part348 McKesson CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g 49348-883_afc09b45-3a66-4edd-bcc5-28b47fa6a10e 49348-883 HUMAN OTC DRUG sunmark arthricream rub Trolamine Salicylate CREAM TOPICAL 20090610 OTC MONOGRAPH NOT FINAL part348 McKesson TROLAMINE SALICYLATE 10 g/100g 49348-888_e73b703b-ce5b-47cf-bd1b-285805ba6cb9 49348-888 HUMAN OTC DRUG sunmark pain reliever Acetaminophen SUSPENSION ORAL 20030821 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL 49348-890_c29cd973-f3ab-45f3-837c-afd4738782fc 49348-890 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20061206 OTC MONOGRAPH FINAL part358H McKesson PYRITHIONE ZINC 1 g/100mL 49348-892_a9a99f90-10f0-467a-9c6e-d4638e88324f 49348-892 HUMAN OTC DRUG Sunmark Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20090804 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 49348-893_e90b00be-b4f9-4262-9a58-61451014a2c1 49348-893 HUMAN OTC DRUG sunmark clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 McKesson POLYETHYLENE GLYCOL 3350 17 g/17g 49348-896_adfcf5ae-e6f1-4707-bbf1-2cbb90a026e3 49348-896 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part333A McKesson Corporation ISOPROPYL ALCOHOL .7 mL/1 49348-897_6c17c3de-00b9-4f92-aa3e-ec48fc7220db 49348-897 HUMAN OTC DRUG Alcohol Prep Pads with Pain Relief benzocaine SWAB TOPICAL 20100219 OTC MONOGRAPH NOT FINAL part348 McKesson BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 49348-905_d1977bbb-e40f-4cc4-8fab-17905ab15a59 49348-905 HUMAN OTC DRUG sunmark Mucus er Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130318 ANDA ANDA078912 McKesson GUAIFENESIN 600 mg/1 49348-917_4f0877a3-431e-4fd2-b006-c232cc5ca3a2 49348-917 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE ORAL 20100824 OTC MONOGRAPH NOT FINAL part334 Mckesson (Sunmark) DOCUSATE SODIUM 100 mg/1 49348-918_ec2a03d6-1a26-451e-a378-377d92e098db 49348-918 HUMAN OTC DRUG Pain reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20110524 OTC MONOGRAPH FINAL part338 Mckesson (Sunmark) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 49348-920_6220eb74-1c4f-4e22-9887-70da296c24cd 49348-920 HUMAN OTC DRUG womans laxative Bisacodyl TABLET ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Mckesson (Sunmark) BISACODYL 5 mg/1 49348-921_ebc79b1d-d574-43e1-80f8-86bb904bdd8a 49348-921 HUMAN OTC DRUG Sunmark Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Sunmark ACETAMINOPHEN 650 mg/1 49348-923_b6a99c03-62be-44af-92fa-644d9d70617d 49348-923 HUMAN OTC DRUG Stomach Relief Liquid Maximum Strength Maximum Strength Pepto Bismol SUSPENSION ORAL 20131108 OTC MONOGRAPH FINAL part335 Sunmark BISMUTH SUBSALICYLATE 525 mg/15mL 49348-924_579c5e78-3a1a-4b93-b1ad-3d71d83c91f7 49348-924 HUMAN OTC DRUG Sunmark Arthritis 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Sunmark ACETAMINOPHEN 650 mg/1 49348-927_d1345cd6-c22d-42a0-b301-cc004df94ec3 49348-927 HUMAN OTC DRUG Sunmark ibuprofen ib Ibuprofen TABLET, COATED ORAL 20060320 ANDA ANDA077349 McKesson IBUPROFEN 200 mg/1 49348-929_e1e28a49-a526-42b0-8a64-c3546094962f 49348-929 HUMAN OTC DRUG Sunmark Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Sunmark LORATADINE 10 mg/1 49348-930_e1e28a49-a526-42b0-8a64-c3546094962f 49348-930 HUMAN OTC DRUG Sunmark Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Sunmark LORATADINE 10 mg/1 49348-934_d936bd0f-14f2-4705-bc20-d2b27477988f 49348-934 HUMAN OTC DRUG sunmark childrens all day allergy cetirizine Hydrochloride LIQUID ORAL 20100909 ANDA ANDA090254 McKesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL 49348-937_777bb87f-ecde-444b-b361-52b1fca524f2 49348-937 HUMAN OTC DRUG Enteric coated aspirin Regular strength Aspirin TABLET, COATED ORAL 20100915 OTC MONOGRAPH FINAL part343 McKesson (Sunmark) ASPIRIN 325 mg/1 49348-939_3c2dd452-9a10-416c-91e6-170ba0723fed 49348-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20110801 ANDA ANDA078862 McKesson CETIRIZINE HYDROCHLORIDE 10 mg/1 49348-940_a2760156-c04b-445c-ad62-fe1f3368531d 49348-940 HUMAN OTC DRUG Sunmark Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20101207 NDA NDA021920 McKesson NAPROXEN SODIUM 220 mg/1 49348-941_69570683-5966-41f0-baf8-625b9811e78a 49348-941 HUMAN OTC DRUG Sunmark Urinary Pain Relief Maximum Strength PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20110910 UNAPPROVED DRUG OTHER McKesson PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 49348-946_f986195f-5b08-4c10-bab6-44fd7855653e 49348-946 HUMAN OTC DRUG Gas Relief Extra strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20110412 OTC MONOGRAPH FINAL part347 McKesson (Sunmark) DIMETHICONE 125 mg/1 49348-953_01f2e040-5701-430c-a03c-e5b8ec71f207 49348-953 HUMAN OTC DRUG Sunmark Stomach relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20110301 OTC MONOGRAPH FINAL part335 McKesson BISMUTH SUBSALICYLATE 262 mg/1 49348-954_5599b10c-3620-4cf5-977e-579d73c38d04 49348-954 HUMAN OTC DRUG Calcium antacid Calcium antacid TABLET, CHEWABLE ORAL 20110407 OTC MONOGRAPH FINAL part331 Sunmark CALCIUM CARBONATE 750 mg/1 49348-955_7d0a075f-452e-4cff-9076-39b42fc85d22 49348-955 HUMAN OTC DRUG Sunmark Assorted Berries calcium carbonate TABLET, CHEWABLE ORAL 20101010 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 750 mg/1 49348-956_8b7bfcc8-5e6b-49c6-93e2-bd7666c41d93 49348-956 HUMAN OTC DRUG Sunmark Tropical fruit Calcium antacid TABLET, CHEWABLE ORAL 20101010 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 750 mg/1 49348-957_4ef36e62-0078-4ee1-858f-95d04f77229c 49348-957 HUMAN OTC DRUG calcium antacid calcium antacid TABLET, CHEWABLE ORAL 20110305 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 500 mg/1 49348-958_af38c50a-0f5d-4893-ab0d-b17a9b2ae474 49348-958 HUMAN OTC DRUG Sunmark calcium antacid calcium carbonate TABLET, CHEWABLE ORAL 20110401 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 500 mg/1 49348-959_1e5cc1e2-6fde-4e2e-9808-f4364497b770 49348-959 HUMAN OTC DRUG Sunmark Assorted fruit Calcium Antacid TABLET, CHEWABLE ORAL 20110404 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 1000 mg/1 49348-960_ebd958f3-8205-430e-9f2b-a67e5ffa4995 49348-960 HUMAN OTC DRUG Earwax Removal Aid Earwax Removal Aid LIQUID AURICULAR (OTIC) 20110124 OTC MONOGRAPH FINAL part344 McKesson CARBAMIDE PEROXIDE 6.5 mg/100mL 49348-968_c1170b59-d1ba-4662-8d7e-e3babd64ed61 49348-968 HUMAN OTC DRUG sunmark fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 McKesson FEXOFENADINE HYDROCHLORIDE 180 mg/1 49348-970_e9b923a0-7915-4a98-a614-1237e30b1440 49348-970 HUMAN OTC DRUG Sunmark fexofenadine hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20110906 ANDA ANDA076447 McKesson FEXOFENADINE HYDROCHLORIDE 60 mg/1 49348-971_9b22a344-24cd-4d4f-968c-073c07b727ee 49348-971 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 20110826 OTC MONOGRAPH FINAL part336 Mckesson (Sunmark) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49348-972_fa33ef6f-3f62-4ff7-a6e8-ef431f4f209d 49348-972 HUMAN OTC DRUG Childrens all day allergy Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 McKesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL 49348-973_e6a80ccc-e33b-4936-b995-ce28f89c7e3b 49348-973 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, COATED ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 325 mg/1 49348-974_9b218a04-28ba-443f-a522-86c25a803cfa 49348-974 HUMAN OTC DRUG Isopropyl Alcohol with Benzocaine Isopropyl Alcohol, Benzocaine SWAB TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part348 McKesson Corporation BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/mL; mL/mL 49348-975_3d9b3e7a-cae1-402d-a5be-cd6b7fd489fc 49348-975 HUMAN OTC DRUG sunmark nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20111121 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 49348-980_8bbbf339-e159-4a6b-8090-9dfd685d2976 49348-980 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, DELAYED RELEASE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 49348-981_9c1ce649-8e4b-4bfc-9bc5-cecd9a015d3b 49348-981 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, DELAYED RELEASE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 49348-982_e1d0d46a-d74f-49da-b12e-ec2cb4fc958f 49348-982 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20110802 OTC MONOGRAPH NOT FINAL part333A McKesson ALCOHOL 65 mL/100L 49348-983_541b6894-84d9-4182-84f2-a65bce63fcf4 49348-983 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl TABLET ORAL 20110928 OTC MONOGRAPH FINAL part336 Mckesson (Sunmark) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49348-984_05657d14-ba53-4412-b69f-382a32de3f47 49348-984 HUMAN OTC DRUG All Day Allergy Relief 24 hour Cetirizine HCl TABLET ORAL 20130315 ANDA ANDA078780 McKesson (Sunmark) CETIRIZINE HYDROCHLORIDE 10 mg/1 49348-985_bb339ab4-5255-4a08-af7d-132e5c3b4231 49348-985 HUMAN OTC DRUG Sinus and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20111207 OTC MONOGRAPH FINAL part341 Mckesson (Sunmark) CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 49348-991_e7941243-58a9-4428-835b-7cd99185cb06 49348-991 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140930 OTC MONOGRAPH NOT FINAL part356 McKesson (Sunmark) PHENOL 1.4 g/100mL 49348-992_9a541106-70d3-4691-a8a8-9955db5196b1 49348-992 HUMAN OTC DRUG Anti-Itch Diphenhydramine HCL, Zinc Acetate SPRAY TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part348 McKesson DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 18; .882 mg/mL; mg/mL 49348-998_af01d992-7930-44e7-9bb9-d0a54785841f 49348-998 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 49348-999_9f3faa14-3717-4c51-a28d-2bad40d4fc88 49348-999 HUMAN OTC DRUG sunmark loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20140218 ANDA ANDA091292 McKesson LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 49349-000_0d4423d4-8764-489e-aee7-f2af160e3b60 49349-000 HUMAN PRESCRIPTION DRUG AFEDITAB CR NIFEDIPINE TABLET, EXTENDED RELEASE ORAL 20100513 NDA NDA123456 RemedyRepack NIFEDIPINE 60 mg/60mg Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49349-001_c5dc8bc3-6475-43fb-9971-3f2e7987a0d0 49349-001 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, CHEWABLE ORAL 20110817 ANDA ANDA075687 REMEDYREPACK INC. CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 49349-002_57f97a6d-77d4-443f-a973-6af0767c8517 49349-002 HUMAN PRESCRIPTION DRUG DICYCLOMINE HYDROCHLORIDE DICYCLOMINE TABLET ORAL 20100723 ANDA ANDA040161 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 49349-003_2befb1e1-6942-47c2-9e83-fdf12d2cbee3 49349-003 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE ORAL 20130719 ANDA ANDA074984 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-003_53aff9c7-d68f-42c3-8441-4b6633cb3d39 49349-003 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE ORAL 20110803 ANDA ANDA074984 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-004_4fc356bc-398e-45bf-a07a-1dee4779064e 49349-004 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20100729 ANDA ANDA075580 REMEDYREPACK INC. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-005_b3abcab5-fcde-4ba1-8fe4-efb7eb450c70 49349-005 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET ORAL 20110802 ANDA ANDA089804 REMEDYREPACK INC. FLUPHENAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 49349-006_65dad3e7-9aa2-45de-b933-0850696d84a4 49349-006 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100730 ANDA ANDA040729 REMEDYREPACK INC. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49349-007_94c9fa37-a9a7-4977-b27b-20e3684b30f3 49349-007 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20100804 ANDA ANDA076752 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-008_fa16c03d-a697-46c8-8ff9-7c5aedcfdb6e 49349-008 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE TABLET ORAL 20101104 ANDA ANDA070772 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 49349-009_02dff358-9c98-4694-bb22-34461b9aec6b 49349-009 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20101108 ANDA ANDA076879 REMEDYREPACK INC. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 49349-010_fc9221c2-e441-4017-bd3c-fd26ea10294e 49349-010 HUMAN PRESCRIPTION DRUG Theophylline Extended Release Theophylline TABLET ORAL 20110707 ANDA ANDA089763 REMEDYREPACK INC. THEOPHYLLINE 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 49349-012_49a3fb64-ee86-4f40-879a-3347f5a84e1e 49349-012 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20100913 ANDA ANDA076921 REMEDYREPACK INC. MIRTAZAPINE 45 mg/1 49349-013_156b3309-94ea-415f-981e-04c0632eda81 49349-013 HUMAN PRESCRIPTION DRUG RIFATER RIFAMPIN, ISONIAZID, PYRAZINAMIDE TABLET, SUGAR COATED ORAL 20100915 NDA NDA050705 REMEDYREPACK INC. ISONIAZID; PYRAZINAMIDE; RIFAMPIN 50; 300; 120 mg/1; mg/1; mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient],Antimycobacterial [EPC],Antimycobacterial [EPC] 49349-015_f1ea1790-f8e4-42cf-a154-4708b82ea007 49349-015 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET ORAL 20100916 ANDA ANDA074461 REMEDYREPACK INC. INDAPAMIDE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 49349-016_c92069f1-d765-4372-8a50-a34d9f08a90e 49349-016 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100916 ANDA ANDA078402 REMEDYREPACK INC. LISINOPRIL 5 mg/1 49349-017_a4c59ee3-6c1e-4fee-818a-f2bd6bbd6032 49349-017 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20100929 NDA NDA018333 REMEDYREPACK INC. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 49349-018_b3df8d7b-a588-4e0b-862e-5b710391ef53 49349-018 HUMAN PRESCRIPTION DRUG Seromycin CYCLOSERINE CAPSULE ORAL 20110802 ANDA ANDA060593 REMEDYREPACK INC. CYCLOSERINE 250 mg/1 49349-019_2520f7d0-fc5d-4d4b-8c59-6e881fc6bb55 49349-019 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20101006 ANDA ANDA075419 REMEDYREPACK INC. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-020_56ecc08f-b340-4223-98d9-f5eae9eb11df 49349-020 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET ORAL 20101001 ANDA ANDA074839 REMEDYREPACK INC. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-021_5a173cc0-60b8-4978-bc69-59d22d8e3d7b 49349-021 HUMAN PRESCRIPTION DRUG NITROFURANTOIN NITROFURANTOIN CAPSULE ORAL 20100917 ANDA ANDA077025 REMEDYREPACK INC. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 49349-021_e3a29354-25d9-43cf-b94c-90621221d284 49349-021 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin CAPSULE ORAL 20131022 ANDA ANDA076648 REMEDYREPACK INC. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 49349-022_65f9512f-fef6-421b-92d6-2b8555daa98d 49349-022 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20130514 ANDA ANDA077653 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-024_ce11eabe-9ca5-4dd6-bea5-254e80b05b68 49349-024 HUMAN PRESCRIPTION DRUG Kaletra Kaletra TABLET ORAL 20100927 ANDA ANDA075659 REMEDYREPACK INC. LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA] 49349-025_2038677c-39f5-4b5e-8e90-03f42ef3d4b7 49349-025 HUMAN PRESCRIPTION DRUG Ranitidine HYdrochloride Ranitidine HYdrochloride TABLET ORAL 20130731 ANDA ANDA077824 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 49349-025_21b64b66-a37a-4304-aede-a9c294e5fa85 49349-025 HUMAN PRESCRIPTION DRUG Ranitidine HYdrochloride RANITIDINE HYDROCHLORIDE TABLET ORAL 20131205 ANDA ANDA077824 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 49349-025_23450096-7a50-42d0-a1dc-cdb0bdfb0d1f 49349-025 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET ORAL 20101025 ANDA ANDA077824 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 49349-025_597d92ff-397c-4e8f-ba3d-b3ccf836e85e 49349-025 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET ORAL 20120112 ANDA ANDA077824 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 49349-028_5c7ea8cc-2953-4b9a-85a2-e15a14b8ef1b 49349-028 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20110720 ANDA ANDA076268 REMEDYREPACK INC. DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 49349-029_6b3d3fd0-6988-45a6-80c1-2a557485ea45 49349-029 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20100921 ANDA ANDA076685 REMEDYREPACK INC. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-030_03119ccf-3eb8-46e5-8252-8683fc14c576 49349-030 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20100928 ANDA ANDA071196 REMEDYREPACK INC. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 49349-031_bb3e3340-e888-485b-80e6-c4266989cfb9 49349-031 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepan TABLET ORAL 20100922 ANDA ANDA075468 REMEDYREPACK INC. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49349-032_04a440ca-69cc-432b-93e5-b89cdacd004f 49349-032 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20110802 ANDA ANDA076649 REMEDYREPACK INC. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 49349-033_1d345720-0012-47f1-aaf4-eb193c64103e 49349-033 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20101011 ANDA ANDA071995 REMEDYREPACK INC. PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-034_fc02acaa-91ab-4897-9f58-2c6c30d60697 49349-034 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20101010 ANDA ANDA070035 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 49349-035_e487b13f-061e-4993-ae8d-5744d2cf31f7 49349-035 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET ORAL 20101011 ANDA ANDA076558 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-036_176913c3-17dd-41dc-a452-941d30faa0a1 49349-036 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET ORAL 20101018 ANDA ANDA076558 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-037_b1a74424-c3c7-4c05-8139-48f1f47738cc 49349-037 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101011 ANDA ANDA074388 REMEDYREPACK INC. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49349-038_bb8e97c9-d152-4c1c-ad0b-79c5b0b3ccc1 49349-038 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20101020 ANDA ANDA076752 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-039_25d95be5-5ab4-4523-b9a6-8ec63664a8fa 49349-039 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20101017 ANDA ANDA078296 REMEDYREPACK INC. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-039_ede2bdae-4a03-4575-b85f-0339463be6b6 49349-039 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20130712 ANDA ANDA078296 REMEDYREPACK INC. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-040_68ab79af-4d3b-4e67-b101-142c7a7123d8 49349-040 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin CAPSULE ORAL 20111110 ANDA ANDA073652 REMEDYREPACK INC. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 49349-041_3a71db9d-48b1-43f2-a0e0-9b34223ee4d1 49349-041 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20101020 ANDA ANDA040145 REMEDYREPACK INC. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-043_1f42ccc3-3826-47fa-b764-c75779b740dd 49349-043 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20101020 ANDA ANDA075967 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-043_69a8a45b-4d2e-4e34-a2f9-8fb390c66874 49349-043 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20131112 ANDA ANDA075967 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-043_dfad824d-9856-4981-b076-6cf5ddebae66 49349-043 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130926 ANDA ANDA075967 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-053_89ac1f3d-50d9-4f8c-bf94-7451afd7cd55 49349-053 HUMAN PRESCRIPTION DRUG TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET ORAL 20101026 ANDA ANDA071525 REMEDYREPACK INC. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 49349-054_f1c0d338-fd08-4292-8681-68e2e6d3b508 49349-054 HUMAN PRESCRIPTION DRUG FUROSEMIDE FUROSEMIDE TABLET ORAL 20101101 ANDA ANDA075659 REMEDYREPACK INC. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 49349-055_33336e18-2a04-4761-afe4-05e730f3c77c 49349-055 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110914 ANDA ANDA078947 REMEDYREPACK INC. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-055_ebbacf01-2749-4931-9f76-830570730f5c 49349-055 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110729 ANDA ANDA078947 REMEDYREPACK INC. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-056_0c741e96-f3b9-46bc-a681-8a2b867f47d6 49349-056 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE TABLET ORAL 20101104 ANDA ANDA070035 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 49349-057_744fb2f4-6240-485c-857f-190b6b9373e5 49349-057 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20101108 ANDA ANDA070175 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-058_93f90b58-26b8-4781-8a9a-c9ca6cb4fbc9 49349-058 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET ORAL 20101108 ANDA ANDA076919 REMEDYREPACK INC. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-059_80eafb53-9ecf-480d-91db-e11d3c2b0c23 49349-059 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20101109 ANDA ANDA080292 REMEDYREPACK INC. PREDNISONE 5 mg/1 49349-060_3f42697e-ec5b-4d6e-8b3e-fc2e5ee4330b 49349-060 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20101110 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 20 mg/1 49349-060_f91a918e-6b39-4011-966b-e79ef7119501 49349-060 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130521 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-061_5af550e1-f31b-4830-8c71-11b418aeb4c2 49349-061 HUMAN PRESCRIPTION DRUG COLCHICINE COLCHICINE TABLET ORAL 20101110 ANDA ANDA075659 REMEDYREPACK INC. COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 49349-062_947954c6-042d-4807-9cd8-1d2b99f18f5e 49349-062 HUMAN PRESCRIPTION DRUG MIRTAZAPINE MIRTAZAPINE TABLET ORAL 20101110 ANDA ANDA077666 REMEDYREPACK INC. MIRTAZAPINE 30 mg/1 49349-063_8b55ad80-b0fd-4fff-a9e2-b1dbecae4bfc 49349-063 HUMAN PRESCRIPTION DRUG TERAZOSIN HYDROCHLORIDE TERAZOSIN HYDROCHLORIDE CAPSULE ORAL 20101110 ANDA ANDA075498 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-064_cb5255bc-1a86-4641-86bb-080626e8c693 49349-064 HUMAN PRESCRIPTION DRUG CALCIUM ACETATE CALCIUM ACETATE CAPSULE ORAL 20101111 ANDA ANDA077728 REMEDYREPACK INC. CALCIUM ACETATE 667 mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 49349-065_d9ed60f2-685c-4fd9-a806-165d90ac9996 49349-065 HUMAN PRESCRIPTION DRUG ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE TABLET ORAL 20101111 ANDA ANDA075095 REMEDYREPACK INC. ETHAMBUTOL HYDROCHLORIDE 100 mg/1 Antimycobacterial [EPC] 49349-066_26490a77-9178-44e8-ab6d-fdc2f2371625 49349-066 HUMAN PRESCRIPTION DRUG STAVUDINE STAVUDINE CAPSULE ORAL 20101111 ANDA ANDA077672 REMEDYREPACK INC. STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-067_2c25d3e9-e43f-476c-9992-b600fdc76a96 49349-067 HUMAN PRESCRIPTION DRUG SULFASALAZINE SULFASALAZINE TABLET ORAL 20101115 ANDA ANDA085828 REMEDYREPACK INC. SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 49349-069_08edd5f4-b624-44ff-bcb6-34429ce14297 49349-069 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131105 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-069_aa316f11-ac82-4c66-b00b-3985003fd067 49349-069 HUMAN PRESCRIPTION DRUG Lisinopril LISINOPRIL TABLET ORAL 20120827 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-069_f3e27541-3352-4c8b-9d95-8a7c34a27a64 49349-069 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20101115 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 10 mg/1 49349-069_fd382469-d9e0-4473-871b-daa3962ac4fb 49349-069 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130521 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-070_bffa1939-9ac1-46a9-b08d-c8015e5723ad 49349-070 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 20130305 NDA AUTHORIZED GENERIC NDA050784 REMEDYREPACK INC. AZITHROMYCIN, UNSPECIFIED FORM 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 49349-071_35ecedcd-6719-42ac-85e8-10f2f409a5a1 49349-071 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE TABLET ORAL 20101115 ANDA ANDA070033 REMEDYREPACK INC. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 49349-072_92a1b237-6578-4d46-bfdd-3c48eb884034 49349-072 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DELAYED RELEASE DIVALPROEX SODIUM TABLET, DELAYED RELEASE ORAL 20101116 ANDA ANDA076941 REMEDYREPACK INC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-073_9b810042-78f2-48dc-8394-808a6ec8c316 49349-073 HUMAN PRESCRIPTION DRUG NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE ORAL 20101116 ANDA ANDA073553 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 49349-074_2246f351-3624-4c0e-8d13-da913f1f8ce6 49349-074 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20130730 ANDA ANDA071251 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 49349-074_4c4ebcd6-11d2-4ea0-b765-31a4e81e9d39 49349-074 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20130821 ANDA ANDA071251 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 49349-074_6c68a539-b0b5-4d64-ab80-b129b675f053 49349-074 HUMAN PRESCRIPTION DRUG TRIAMTERENE AND HYDROCHLOROTHIAZIDE TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET ORAL 20101117 ANDA ANDA071251 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-077_b5c0e611-831a-4fa4-bb51-1213778f19ee 49349-077 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET ORAL 20101117 ANDA ANDA076003 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 49349-078_643e804a-4bca-4025-b73c-800f805697fa 49349-078 HUMAN PRESCRIPTION DRUG DAPSONE DAPSONE TABLET ORAL 20101118 ANDA ANDA086841 REMEDYREPACK INC. DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] 49349-078_7603d1c3-fb86-42db-9356-564a6f63c0cf 49349-078 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20130729 ANDA ANDA086842 REMEDYREPACK INC. DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] 49349-078_d0736f0c-520b-495a-a814-cce33ccd1938 49349-078 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20130829 ANDA ANDA086842 REMEDYREPACK INC. DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] 49349-079_517e04f2-fe7e-46ad-a40d-abf7c32d0ac1 49349-079 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET ORAL 20101118 ANDA ANDA088467 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 49349-080_17e1d7e5-84a8-42fe-b437-0e2c768e5b60 49349-080 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20101118 ANDA ANDA040813 REMEDYREPACK INC. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49349-081_06bc43d8-4a18-447e-b39a-41c228ae084b 49349-081 HUMAN PRESCRIPTION DRUG CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM TABLET ORAL 20101118 ANDA ANDA076911 REMEDYREPACK INC. CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 49349-082_c1bb5fab-dfe7-455e-80d4-404765cf4ab1 49349-082 HUMAN PRESCRIPTION DRUG DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE CAPSULE ORAL 20101120 ANDA ANDA085082 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 49349-083_a42185b5-c80f-4fe4-9f55-6416f0b6158d 49349-083 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET ORAL 20101120 ANDA ANDA078069 REMEDYREPACK INC. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-084_bda607bd-299f-4a30-a322-e31e878accb6 49349-084 HUMAN PRESCRIPTION DRUG VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20101122 ANDA ANDA071367 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-085_18caa8ec-d829-493e-ba4d-43ec56644149 49349-085 HUMAN PRESCRIPTION DRUG FUROSEMIDE FUROSEMIDE TABLET ORAL 20101122 ANDA ANDA076796 REMEDYREPACK INC. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 49349-086_3f1bb014-493c-4259-be80-622f9946e956 49349-086 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE TABLET ORAL 20101122 ANDA ANDA076896 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-087_5eccf4fb-0af6-4fd0-94ec-123e0c73cc41 49349-087 HUMAN PRESCRIPTION DRUG FLUCONAZOLE FLUCONAZOLE TABLET ORAL 20101122 ANDA ANDA076077 REMEDYREPACK INC. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 49349-088_ad58c87a-0e8b-411b-921b-c45fe9797182 49349-088 HUMAN PRESCRIPTION DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET ORAL 20101123 ANDA ANDA078317 REMEDYREPACK INC. CETIRIZINE HYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 49349-089_82a69541-02ab-4131-8267-a2c3c73ee739 49349-089 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET ORAL 20101123 ANDA ANDA077653 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-092_a431bed7-cdc1-4924-bbe4-5a493f003c1c 49349-092 HUMAN PRESCRIPTION DRUG GLIPIZIDE GLIPIZIDE TABLET ORAL 20101123 ANDA ANDA074223 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49349-093_733563e1-b20b-47cd-bec9-a1bde2623329 49349-093 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20120830 ANDA ANDA076112 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-093_d08aafee-0e7a-4bb5-8234-9d6373a908e0 49349-093 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET ORAL 20101123 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-094_24397726-3cc0-4266-a5d4-62f53b62e5e5 49349-094 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130411 ANDA ANDA076649 REMEDYREPACK INC. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 49349-095_8028d470-4789-4044-ba01-a350326ebe29 49349-095 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM EXTENDED RELEASE DIVALPROEX SODIUM TABLET, EXTENDED RELEASE ORAL 20101124 ANDA ANDA077567 REMEDYREPACK INC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-096_4c3e0d96-c633-400b-be2f-31f9eadf1eaf 49349-096 HUMAN PRESCRIPTION DRUG CIMETIDINE CIMETIDINE TABLET ORAL 20101124 ANDA ANDA074890 REMEDYREPACK INC. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 49349-098_f7b6a433-2e09-437c-8c9b-aeb4adc34ee5 49349-098 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 20101130 ANDA ANDA084878 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-099_15a131a3-9210-4b0e-aeb8-11ae8bb7b5ff 49349-099 HUMAN PRESCRIPTION DRUG DILANTIN PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20101130 ANDA ANDA084349 REMEDYREPACK INC. PHENYTOIN SODIUM 30 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-100_ccf436a0-03f9-4f03-a65e-9ea0dece004d 49349-100 HUMAN PRESCRIPTION DRUG LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20101130 ANDA ANDA074787 REMEDYREPACK INC. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-101_2936ca1f-5fc2-40a7-a66d-37462aab8450 49349-101 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE ORAL 20101130 ANDA ANDA077567 REMEDYREPACK INC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-102_a3d4e193-caa5-4f9f-9424-454db0a4bfec 49349-102 HUMAN PRESCRIPTION DRUG LOXAPINE SUCCINATE LOXAPINE SUCCINATE CAPSULE ORAL 20101130 ANDA ANDA072204 REMEDYREPACK INC. LOXAPINE SUCCINATE 5 mg/1 49349-103_7d8e1d78-0778-4da2-8933-0e567412b2ab 49349-103 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130604 NDA NDA020702 REMEDYREPACK INC. ATORVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-104_f4144a6c-3a7e-4623-9bb9-d7f3afc3bc03 49349-104 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20140109 NDA NDA021283 REMEDYREPACK INC. VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49349-104_fca7ac2f-c9a5-460d-810a-0ff000a45e7e 49349-104 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20140109 NDA NDA021283 REMEDYREPACK INC. VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49349-105_d22dc4e2-33ce-4a01-887e-0af9e029fe3b 49349-105 HUMAN PRESCRIPTION DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET ORAL 20101201 ANDA ANDA078317 REMEDYREPACK INC. CETIRIZINE HYDROCHLORIDE 10 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 49349-106_6c563182-f353-411b-b706-a4e404e0d499 49349-106 HUMAN PRESCRIPTION DRUG DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE ORAL 20101202 ANDA ANDA070792 REMEDYREPACK INC. DOXEPIN HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 49349-107_70101347-f23d-4ddd-87a2-84984873cc5e 49349-107 HUMAN PRESCRIPTION DRUG ALLOPURINOL ALLOPURINOL TABLET ORAL 20101202 ANDA ANDA018659 REMEDYREPACK INC. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 49349-109_64b1ce83-8a3b-43dc-a3c4-d3691e0d6b39 49349-109 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20101202 ANDA ANDA077272 REMEDYREPACK INC. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 49349-110_b7a94a70-39e0-485c-bc09-76f82375dfde 49349-110 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130514 NDA NDA020702 REMEDYREPACK INC. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-112_c6bd1e7d-b742-4e2c-a7b5-034dc4f27763 49349-112 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130415 ANDA ANDA076649 REMEDYREPACK INC. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 49349-112_e090bd60-4d5e-4cdb-86c0-edffcae0c3d8 49349-112 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130415 ANDA ANDA076649 REMEDYREPACK INC. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 49349-113_0aedd9ac-968a-4a38-86ac-4997186a2fd6 49349-113 HUMAN PRESCRIPTION DRUG INDOMETHACIN INDOMETHACIN CAPSULE ORAL 20101206 ANDA ANDA070719 REMEDYREPACK INC. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-114_c8273799-b45c-4d94-ba74-074516932669 49349-114 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE TABLET ORAL 20101206 ANDA ANDA074761 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-115_47308500-6387-4433-b24c-1e35f0bf0b80 49349-115 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 20101206 ANDA ANDA077824 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 49349-116_87df1418-b4dd-46c3-a0f8-f44d8b2828cf 49349-116 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20130410 ANDA ANDA079153 REMEDYREPACK INC. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-117_e6285599-4360-4f56-8ea8-11e146be7083 49349-117 HUMAN PRESCRIPTION DRUG DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE ORAL 20101207 ANDA ANDA070790 REMEDYREPACK INC. DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 49349-118_8b6cb9dc-208e-428b-ba6a-b27c0926c8ef 49349-118 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20130410 ANDA ANDA079153 REMEDYREPACK INC. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-119_a6491edd-d53b-426c-a795-2d4f5fada03c 49349-119 HUMAN PRESCRIPTION DRUG ALLOPURINOL ALLOPURINOL TABLET ORAL 20101207 ANDA ANDA018832 REMEDYREPACK INC. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 49349-120_33630882-3356-496c-8149-a278dbb2d84a 49349-120 HUMAN PRESCRIPTION DRUG BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET ORAL 20101207 ANDA ANDA076008 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 30 mg/1 49349-121_8c7e0437-a0cf-44e8-bb46-6dffebfc46ae 49349-121 HUMAN PRESCRIPTION DRUG LOXAPINE SUCCINATE LOXAPINE SUCCINATE CAPSULE ORAL 20101208 ANDA ANDA072205 REMEDYREPACK INC. LOXAPINE SUCCINATE 10 mg/1 49349-122_4136748b-9449-4da1-bdd5-5532162255b0 49349-122 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20101208 ANDA ANDA076752 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-123_33ff86a3-5a4e-4762-a3d6-426cb74e2a47 49349-123 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET ORAL 20101208 ANDA ANDA075659 REMEDYREPACK INC. IBUPROFEN 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-124_b4702714-5806-4ec1-b02e-73f83a3d6c1a 49349-124 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20130408 ANDA ANDA076077 REMEDYREPACK INC. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 49349-124_def18b24-09d1-4757-8de9-3026417979c7 49349-124 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20141029 ANDA ANDA076077 REMEDYREPACK INC. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 49349-124_fe4c9f68-3097-48b2-b9de-0e1664598cd7 49349-124 HUMAN PRESCRIPTION DRUG FLUCONAZOLE FLUCONAZOLE TABLET ORAL 20101208 ANDA ANDA076077 REMEDYREPACK INC. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 49349-126_f68072e5-a456-4086-8a6e-3351bbb12373 49349-126 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20101209 ANDA ANDA072264 REMEDYREPACK INC. BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 49349-128_85265fdb-e138-46c2-8e01-def0257dc1de 49349-128 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride Thioridazine Hydrochloride TABLET ORAL 20110404 ANDA ANDA088004 REMEDYREPACK INC. THIORIDAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 49349-129_fe744b23-8c8c-4041-9784-3d3f17840dd5 49349-129 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorthiazide Lisinopril and Hydrochlorthiazide TABLET ORAL 20110404 ANDA ANDA076674 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-130_33c51611-a27b-4984-b102-b629b1efffdd 49349-130 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride Thioridazine Hydrochloride TABLET ORAL 20110404 ANDA ANDA088004 REMEDYREPACK INC. THIORIDAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 49349-131_f93d64b2-68b7-4c9f-8286-bc7ba8d772d7 49349-131 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20110404 ANDA ANDA072824 REMEDYREPACK INC. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 49349-132_1c01014e-96b5-42e9-8577-3eb94b097534 49349-132 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110125 ANDA ANDA076752 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-136_6bd4ee56-ff0d-4707-8e42-eb8e98da10cc 49349-136 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 20110404 ANDA ANDA071588 REMEDYREPACK INC. DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 49349-137_78911948-a147-4cbd-93b4-a5a0388ca163 49349-137 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110126 ANDA ANDA076752 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-138_8cfdd740-3605-4b96-8a10-6a3f0ef8bf06 49349-138 HUMAN PRESCRIPTION DRUG Cozaar Cozaar TABLET ORAL 20110407 NDA NDA020386 REMEDYREPACK INC. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49349-139_cab89682-626c-416d-9239-f0a0d17ab6d3 49349-139 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110404 ANDA ANDA078597 REMEDYREPACK INC. VALPROIC ACID 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-140_afbfa279-6b46-4789-b8bd-71f97ae9e909 49349-140 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20110407 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-142_802c7457-b2ff-41b5-8560-076211a606e4 49349-142 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110914 ANDA ANDA079153 REMEDYREPACK INC. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-142_f224fde7-50dd-459d-adde-c81be805ad1c 49349-142 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110425 ANDA ANDA079153 REMEDYREPACK INC. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-143_3f87c9f7-9876-4cc0-a318-1dbef1e5af87 49349-143 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110408 ANDA ANDA076418 REMEDYREPACK INC. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49349-144_b7a6fbb7-ec7b-4f8f-898f-b486fe625c5e 49349-144 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20110408 ANDA ANDA075483 REMEDYREPACK INC. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 49349-145_24d3e019-f410-47f0-ad2d-dd1ecba175fc 49349-145 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20110408 ANDA ANDA078069 REMEDYREPACK INC. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-148_5a622f04-cb7f-4618-8217-c126a23ecda6 49349-148 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET ORAL 20110411 ANDA ANDA040120 REMEDYREPACK INC. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 49349-150_0cfd2cac-14bf-478b-b0c8-04d7a62773d5 49349-150 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20110411 ANDA ANDA076879 REMEDYREPACK INC. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 49349-151_5ba0985b-b560-4946-8496-b194ccd87772 49349-151 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110411 ANDA ANDA075124 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-153_77df5555-acec-4afa-8e22-1a8c301b63a5 49349-153 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20110509 ANDA ANDA077309 REMEDYREPACK INC. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-154_92073e81-4442-4400-9732-b48b5b92bb31 49349-154 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20110412 ANDA ANDA079029 REMEDYREPACK INC. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 49349-155_2c7ef55a-a6ef-449c-bbb1-699a7378b667 49349-155 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20110425 ANDA ANDA074131 REMEDYREPACK INC. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-155_8711fb8e-7014-4049-b9e7-24c09ea214bc 49349-155 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20110412 ANDA ANDA074131 REMEDYREPACK INC. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-156_116866cd-395c-40b4-8474-3935f44373ce 49349-156 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20110413 ANDA ANDA076832 REMEDYREPACK INC. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 49349-157_eae2456f-027e-4340-a228-64924634c30a 49349-157 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20110413 ANDA ANDA075868 REMEDYREPACK INC. FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 49349-158_693e20ca-1ec3-4db1-84cc-4f4c14444b86 49349-158 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110420 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 40 mg/1 49349-158_b2244f5f-e5ca-4012-a9a5-727908cc2881 49349-158 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130405 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-159_8eaf20e9-ed6b-424b-b3fa-0b253b5f724a 49349-159 HUMAN PRESCRIPTION DRUG Propoxyphene Napsylate and Acetaminophen Propoxyphene Napsylate and Acetaminophen TABLET ORAL 20110215 ANDA ANDA075738 REMEDYREPACK INC. ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 650; 100 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 49349-160_652de301-420f-417a-9a2d-7f2156aa48da 49349-160 HUMAN PRESCRIPTION DRUG Amlodipine Amlodipine TABLET ORAL 20110413 ANDA ANDA076719 REMEDYREPACK INC. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49349-161_c9e9050a-9ee0-479d-a881-6a2dbb6da7d8 49349-161 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20110413 ANDA ANDA090637 REMEDYREPACK INC. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 49349-162_9eef8bfc-ed3d-47a6-af44-3de47e881310 49349-162 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET ORAL 20110413 ANDA ANDA040766 REMEDYREPACK INC. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 49349-164_3d42d015-3091-4bd2-84e5-eb78ad530665 49349-164 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110413 ANDA ANDA070044 REMEDYREPACK INC. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 49349-164_97a1c265-cec8-4974-a71d-24448c647701 49349-164 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110413 ANDA ANDA070044 REMEDYREPACK INC. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 49349-164_c50fbb37-739e-42a0-93d9-e0c5bbf43edb 49349-164 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110413 ANDA ANDA070044 REMEDYREPACK INC. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 49349-165_d90ab751-93c1-4850-8bc5-2169027e976e 49349-165 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET ORAL 20110414 ANDA ANDA074680 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 49349-166_3a10fa68-30d2-46ee-b413-76e6bc245217 49349-166 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110414 ANDA ANDA077877 REMEDYREPACK INC. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-167_4c3100b5-8721-4d47-bb1a-70f1c595ae46 49349-167 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110414 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 40 mg/1 49349-169_3b8e599f-7436-4f1e-9bfa-9c4523c43647 49349-169 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20110414 ANDA ANDA077691 REMEDYREPACK INC. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-170_659dba85-f975-4eba-965d-17e37e0f99aa 49349-170 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20110418 ANDA ANDA075795 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49349-171_d4de41d1-933e-47de-919c-a53c5455b69d 49349-171 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET ORAL 20110418 ANDA ANDA075356 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-172_efaf6d9d-7c05-43ef-99f2-14a8c9fcef9a 49349-172 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 20110418 ANDA ANDA072099 REMEDYREPACK INC. DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 49349-173_f61d2d2b-42a4-4041-b219-129ba7b9664c 49349-173 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20110418 ANDA ANDA040218 REMEDYREPACK INC. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 49349-175_ef4a0ca9-1a8f-4304-b5a6-00c2ca131d5c 49349-175 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20110418 ANDA ANDA074388 REMEDYREPACK INC. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49349-176_a2ef192f-9b3a-4c8b-baf1-ae27788ca728 49349-176 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110425 ANDA ANDA077877 REMEDYREPACK INC. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-176_edf51394-dd38-4712-b2a6-d23ed0acb35f 49349-176 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110425 ANDA ANDA077877 REMEDYREPACK INC. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-177_208a9cff-3e17-45c5-a91c-87a103c3652c 49349-177 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110418 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-177_8c234632-a2d9-476b-9871-55cfd64337e0 49349-177 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110418 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-177_e3cfeab3-1fb6-4a04-9f61-623c6e7d5761 49349-177 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110418 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-178_08770c34-ed1a-4190-bd4e-8b078f4533fa 49349-178 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20110419 ANDA ANDA085828 REMEDYREPACK INC. SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 49349-179_9c63f233-386a-4ba0-ac28-0a975444f5ca 49349-179 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20110419 ANDA ANDA086242 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 49349-180_0bb3abbc-9c84-47d3-80fa-f38cc311ef4a 49349-180 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20110419 ANDA ANDA071976 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-180_1059e36b-e084-48f3-a4ee-82f28c2dd985 49349-180 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20110419 ANDA ANDA071973 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-182_b8c1fa26-6c8f-4b46-8c18-909ecae5a4c1 49349-182 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110419 ANDA ANDA075360 REMEDYREPACK INC. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-184_986fff8d-a75a-4346-977b-cedbe81d7804 49349-184 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20110425 ANDA ANDA077653 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-185_5c68581c-e60a-4ba2-8d2d-fcf34cbf37a8 49349-185 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20110419 ANDA ANDA074217 REMEDYREPACK INC. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-186_3091c26e-3a36-4b14-a551-360f1a846b0c 49349-186 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20110419 ANDA ANDA078459 REMEDYREPACK INC. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-186_f63c14d0-987c-4039-b165-51457bb5c69d 49349-186 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20130603 ANDA ANDA078459 REMEDYREPACK INC. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-189_75e18c45-8f5d-40f7-bd2e-21f993151a28 49349-189 HUMAN PRESCRIPTION DRUG FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20101223 ANDA ANDA089804 REMEDYREPACK INC. FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 49349-190_ab1394ad-7bc1-422c-9334-5bfa10647efb 49349-190 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20110419 ANDA ANDA070177 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-191_86556cf0-93df-47b9-b2a8-6159f88c1e8c 49349-191 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20110420 ANDA ANDA075896 REMEDYREPACK INC. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49349-192_86327d2f-9e35-4849-9416-6977b74ab373 49349-192 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20110420 ANDA ANDA078216 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-193_af3df63d-9f06-431b-b86b-f0643af4594e 49349-193 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 20110420 ANDA ANDA078720 REMEDYREPACK INC. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 49349-194_6a3e25f1-f670-4b8e-b1b3-8a998ebaa19f 49349-194 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20110420 ANDA ANDA076794 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-195_0beef3b2-3693-4aab-9a57-20f8dfc4bf5c 49349-195 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20110420 ANDA ANDA065384 REMEDYREPACK INC. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 49349-196_cb112051-e817-42e4-b699-f46211505688 49349-196 HUMAN PRESCRIPTION DRUG Divalproex Sodium Delayed Release Divalproex Sodium Delayed Release TABLET, DELAYED RELEASE ORAL 20110420 ANDA ANDA078597 REMEDYREPACK INC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-197_52cb89ab-2c66-4ba1-8c2a-235df5ed5deb 49349-197 HUMAN PRESCRIPTION DRUG Divalproex Sodium Delayed Release Divalproex Sodium Delayed Release TABLET, DELAYED RELEASE ORAL 20110420 ANDA ANDA078597 REMEDYREPACK INC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-198_d4d43ee1-fd38-49d0-8e14-ab1aff270e9a 49349-198 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20110421 ANDA ANDA072101 REMEDYREPACK INC. DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 49349-199_610247ab-44ef-4288-9e7e-71a3526544e3 49349-199 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20110421 ANDA ANDA074681 REMEDYREPACK INC. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 49349-201_078463b0-bc4b-44a3-9a5c-7c106082d661 49349-201 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Extended Release Metformin Hydrochloride Extended Release TABLET, EXTENDED RELEASE ORAL 20110421 ANDA ANDA075979 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-203_47fcb9ca-b303-4bfd-a691-dad8ed351588 49349-203 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110421 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-204_2c2658a1-9e32-4e15-8a3e-38eab508266f 49349-204 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20110421 ANDA ANDA071745 REMEDYREPACK INC. PRAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-205_98317361-6981-4d84-9570-4fe0854ea046 49349-205 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110421 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-206_750238f2-8b38-4763-8f46-d91ff0113dfb 49349-206 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20110421 ANDA ANDA074174 REMEDYREPACK INC. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49349-207_b7cd8aed-05b1-4a99-9326-734c53175ba4 49349-207 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20110421 ANDA ANDA081049 REMEDYREPACK INC. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 49349-208_8231482b-7b72-493e-a733-ab3bd9b98145 49349-208 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 20130410 NDA NDA020634 REMEDYREPACK INC. LEVOFLOXACIN 500 mg/1 49349-208_db82331c-8336-40fd-b244-963c0e84f0de 49349-208 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 20130703 NDA NDA020634 REMEDYREPACK INC. LEVOFLOXACIN 500 mg/1 49349-209_490df0ee-46ec-464a-a0cb-7c8c099f7b39 49349-209 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20131031 ANDA ANDA076194 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-209_bc9a2d60-856e-45cc-8a50-c23fe04eac03 49349-209 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20131112 ANDA ANDA076194 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-209_caaa1fee-0862-4558-930f-2b07d3e86dba 49349-209 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20110422 ANDA ANDA076194 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-210_300b5ec4-482d-45b5-afca-dd6ea661aa84 49349-210 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20130424 ANDA ANDA079088 REMEDYREPACK INC. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 49349-211_c4c9012d-0829-49ab-aafb-3ed67ca6db9f 49349-211 HUMAN PRESCRIPTION DRUG Cozaar Cozaar TABLET, FILM COATED ORAL 20110422 NDA NDA020386 REMEDYREPACK INC. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49349-212_77cbcf62-6304-49d4-b91f-c1e0f1a5fbaa 49349-212 HUMAN PRESCRIPTION DRUG Loxapine Succinate Loxapine Succinate CAPSULE ORAL 20110426 ANDA ANDA072062 REMEDYREPACK INC. LOXAPINE SUCCINATE 50 mg/1 49349-213_2ce8a26d-6eb9-498d-b8bf-1609fc949c47 49349-213 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20110426 ANDA ANDA078216 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-216_ad99fb68-2d5f-4e29-a841-e8e2d1e1f82d 49349-216 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110426 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-217_3f3f50bc-c2d5-46a4-9c41-b3625011a3ba 49349-217 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20110426 ANDA ANDA071611 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49349-218_40edf56f-dd24-41e0-8002-986e2fd1e0a5 49349-218 HUMAN PRESCRIPTION DRUG Loratadineantihistamine antihistamine Loratadine TABLET ORAL 20130520 ANDA ANDA076301 REMEDYREPACK INC. LORATADINE 10 mg/1 49349-220_10fd3ed1-fbbb-4c5c-81fe-cfd5eb4a6979 49349-220 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110301 ANDA ANDA078428 REMEDYREPACK INC. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-222_86af6d2e-bb35-43ef-aaa2-73e4c15eb6a0 49349-222 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130327 ANDA ANDA079095 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49349-222_b565e835-012d-4798-96a6-ec609bc1ebcf 49349-222 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110301 ANDA ANDA079095 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49349-223_20d06a8c-5ee6-4912-8eeb-9a5d4f330401 49349-223 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20110427 ANDA ANDA089808 REMEDYREPACK INC. THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 49349-224_004c3d4e-c4d9-4fd0-bbf1-a0d68aa5a046 49349-224 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110308 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-225_9299aa50-6975-44ce-b55b-a742ff35fe92 49349-225 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110308 ANDA ANDA076752 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-226_31192ed3-510a-4e1e-99f6-0df33cfba26a 49349-226 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended Release Divalproex Sodium Extended Release TABLET, EXTENDED RELEASE ORAL 20110506 ANDA ANDA077567 REMEDYREPACK INC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-227_a374c2b2-8487-42a2-bde0-9c4ac3dc5cb5 49349-227 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20110428 ANDA ANDA078955 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-228_60c53952-5591-4145-8eb2-270915595591 49349-228 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20110428 ANDA ANDA074223 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49349-229_d9d4960b-35c7-4f6f-b555-210dee465964 49349-229 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20110428 ANDA ANDA086242 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 49349-230_99a87179-f88c-4290-b3f7-e67625fb0ef8 49349-230 HUMAN PRESCRIPTION DRUG Bupropion Hydrocloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20110314 ANDA ANDA075584 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49349-231_a4c727e4-8761-4b4d-8ad7-69512918c760 49349-231 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20110314 ANDA ANDA072266 REMEDYREPACK INC. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 49349-232_666b41f9-5811-4af2-8da4-06297477ed39 49349-232 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110429 ANDA ANDA077064 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-233_25920813-afc2-448b-9f10-386571d86fff 49349-233 HUMAN PRESCRIPTION DRUG Cozaar Cozaar TABLET, FILM COATED ORAL 20110519 NDA NDA020386 REMEDYREPACK INC. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49349-234_9fbe0420-cad9-4935-80c4-8856e8b6a2df 49349-234 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20110502 ANDA ANDA077653 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-235_92db3ca4-b38d-4f7c-a737-49906e2563ed 49349-235 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110316 ANDA ANDA077877 REMEDYREPACK INC. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-236_86aa067a-7407-4296-ae07-f0c20fd4b9e7 49349-236 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20110505 ANDA ANDA079088 REMEDYREPACK INC. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 49349-237_7ee65049-eb54-44cd-a300-af5e439cfa14 49349-237 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20130430 ANDA ANDA079088 REMEDYREPACK INC. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 49349-238_b99fdd84-3d62-456b-9fe0-d527e397748a 49349-238 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110318 ANDA ANDA078790 REMEDYREPACK INC. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-239_f48a8c44-96a5-4cab-a1e7-8b5155df188d 49349-239 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20110503 ANDA ANDA078008 REMEDYREPACK INC. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-240_15bdd687-2695-4b54-b5f9-8feb655237f3 49349-240 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110503 ANDA ANDA076752 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-241_9111db48-1d62-4e3b-a429-3e7ce74f9c91 49349-241 HUMAN PRESCRIPTION DRUG Seroquel Seroquel TABLET, EXTENDED RELEASE ORAL 20110323 NDA NDA022047 REMEDYREPACK INC. QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] 49349-242_d233a29a-3bee-46c7-a0ca-48756084a207 49349-242 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 20110323 ANDA ANDA073186 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-243_78762981-d388-4167-b10f-f6aaa9b4ed28 49349-243 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20130927 ANDA ANDA070027 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 49349-243_bb9113fc-1eba-4a4d-a8f3-662555c30c20 49349-243 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20120823 ANDA ANDA070027 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 49349-243_ff09c3e3-6ddc-45be-a39a-c88ec392ca1d 49349-243 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110503 ANDA ANDA070027 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 49349-244_bd8129e9-2ee3-4877-b7af-5c7614f1770c 49349-244 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20110914 ANDA ANDA075694 REMEDYREPACK INC. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-244_f1ed23df-d6b2-4886-9bb8-328792b4af5e 49349-244 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20110525 ANDA ANDA075694 REMEDYREPACK INC. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-245_fd4fd0bd-a5ce-4b97-a568-20a5fdcfbda9 49349-245 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20110328 ANDA ANDA077606 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-246_6fcf8e7b-f867-437d-bd37-49c77f54886e 49349-246 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET ORAL 20110505 ANDA ANDA077859 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-247_624a7112-3b8f-47a6-87cf-772ac7b8bd39 49349-247 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20110328 ANDA ANDA076007 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-248_b3d77101-6850-455b-bad2-4c3c437ba152 49349-248 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20110504 ANDA ANDA077912 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-249_65791775-b885-450c-b097-6133fcd98ab7 49349-249 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20110328 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 49349-250_3ef97bdb-48eb-42ab-a599-32a77a79d4a4 49349-250 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20110328 ANDA ANDA064150 REMEDYREPACK INC. RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 49349-251_98ad15fd-aaa6-49af-8a4d-0db975323ed1 49349-251 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20110504 ANDA ANDA065384 REMEDYREPACK INC. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 49349-252_443ffacd-4615-447d-a3fc-e1f9cf7dd28b 49349-252 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20110328 ANDA ANDA070924 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 49349-253_f526d46c-6162-4be2-bd27-fab3ab079d2c 49349-253 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110329 ANDA ANDA076187 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-254_d2611020-336d-470e-af73-5096cba737d9 49349-254 HUMAN PRESCRIPTION DRUG Dilantin Dilantin CAPSULE, EXTENDED RELEASE ORAL 20110505 ANDA ANDA084349 REMEDYREPACK INC. PHENYTOIN SODIUM 30 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-255_84159e06-35dc-4bf7-85d1-0e746b52b3c3 49349-255 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride Paroxetine Hydrochloride TABLET ORAL 20110329 ANDA ANDA077584 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-256_00671107-f919-490d-9d2b-a4ff1582c727 49349-256 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110329 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 5 mg/1 49349-258_44e5ce39-f869-4ef4-975c-533df4c477f5 49349-258 HUMAN PRESCRIPTION DRUG Flomax Flomax CAPSULE ORAL 20110330 NDA NDA020579 REMEDYREPACK INC. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-259_7545e42c-bfb0-4fb3-8565-74084c6ae723 49349-259 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortiptyline Hydrochloride CAPSULE ORAL 20110330 ANDA ANDA073554 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 49349-260_0557e713-bcce-4d99-bcd8-d8d7942de23a 49349-260 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20110330 ANDA ANDA065005 REMEDYREPACK INC. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 49349-261_9353f15c-735e-4ef9-be6f-ff27f122b947 49349-261 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20110506 ANDA ANDA078069 REMEDYREPACK INC. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-262_5d878477-51c1-4ae3-ad5b-776eda1c1ab7 49349-262 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20110330 ANDA ANDA076122 REMEDYREPACK INC. MIRTAZAPINE 30 mg/1 49349-263_b21b90d5-907a-4c6d-83be-cb4fbbe81b7d 49349-263 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20110331 ANDA ANDA076312 REMEDYREPACK INC. MIRTAZAPINE 15 mg/1 49349-264_9804b4df-6a1c-4de4-ab15-3f47777d04ec 49349-264 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20110509 ANDA ANDA075509 REMEDYREPACK INC. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-265_f15e7aad-57be-4730-b7ce-1998c89e8005 49349-265 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110331 ANDA ANDA078428 REMEDYREPACK INC. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-266_4d4b1326-93bb-4902-a8a1-58ba9c1b0fbd 49349-266 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110509 ANDA ANDA084325 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-268_318c6466-c488-461c-a1cf-fa21f487ab9b 49349-268 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20110331 ANDA ANDA075509 REMEDYREPACK INC. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-269_1ad878ac-0d89-490c-8587-c1d8c6f44131 49349-269 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20110509 ANDA ANDA075090 REMEDYREPACK INC. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-270_04637e52-5d99-44cc-9cc0-4d0f06aeb130 49349-270 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110512 ANDA ANDA079095 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49349-270_c6397a2e-b21c-4a1b-9a35-4e18362e844c 49349-270 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120830 ANDA ANDA077715 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49349-271_62aea5ae-6e5a-4784-bfc2-332ae5b3597c 49349-271 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20130501 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 49349-272_22db1ee9-ed4c-4ed0-8f0c-28177a225e87 49349-272 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131119 ANDA ANDA076467 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49349-272_c6b89c7f-fc9c-46ba-b65e-d9ab7550dffb 49349-272 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110601 ANDA ANDA076467 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49349-275_af577159-412f-40ee-b903-5e6b22fd7ca8 49349-275 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20110601 ANDA ANDA065174 REMEDYREPACK INC. CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 49349-276_34bc784f-bd4a-4b6c-be8c-3d5dde7ff031 49349-276 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20110602 ANDA ANDA074394 REMEDYREPACK INC. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-277_8887cb99-b179-4877-a931-9dcfd78da2fd 49349-277 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20110712 ANDA ANDA084277 REMEDYREPACK INC. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49349-278_f41e02eb-74c3-41f9-b834-41fd25000a6a 49349-278 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110603 ANDA ANDA078494 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-279_65d024ee-0bd0-48f0-90a5-b9e6bd201cd3 49349-279 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET ORAL 20110603 ANDA ANDA089584 REMEDYREPACK INC. FLUPHENAZINE HYDROCHLORIDE 2.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 49349-280_e5fc205a-45f8-4ec6-8444-32cf549acdd0 49349-280 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110606 ANDA ANDA077877 REMEDYREPACK INC. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-281_360a3961-6fcb-4f91-85bc-837d492bcdd4 49349-281 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20110607 ANDA ANDA076017 REMEDYREPACK INC. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-282_4525a8da-57a5-40c9-a217-87661926055c 49349-282 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20110606 ANDA ANDA075509 REMEDYREPACK INC. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-283_f6d556c7-aae3-4e60-a3ce-adc5ccb2aad5 49349-283 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20110606 ANDA ANDA075776 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-284_28cc0d08-19a5-4d1c-82fa-2eeca8b48923 49349-284 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20130424 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 49349-284_4f2003b6-7a7f-4802-b2d8-eef9375bf4ab 49349-284 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20130424 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 49349-285_555a2122-d131-4474-b888-ba370a6e21fd 49349-285 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride Paroxetine Hydrochloride TABLET ORAL 20110607 ANDA ANDA077584 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-286_d6c2476b-5fd8-4bdb-9484-7410d2b29d05 49349-286 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET ORAL 20110822 ANDA ANDA076447 REMEDYREPACK INC. FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 49349-287_4d3ff899-dd2c-44b5-9ca7-be82807750b6 49349-287 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE TABLET ORAL 20141230 NDA AUTHORIZED GENERIC NDA011839 REMEDYREPACK INC. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 49349-287_d8b60a4f-09f9-4bd6-a8a9-09b17360f696 49349-287 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 20110607 NDA AUTHORIZED GENERIC NDA011839 REMEDYREPACK INC. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 49349-288_23823160-5d18-4860-aa56-8f0ed6e9660e 49349-288 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110608 ANDA ANDA078597 REMEDYREPACK INC. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-289_02a0e6ee-6b63-47ac-869f-f87c7941be34 49349-289 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20130423 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 49349-290_0daad865-c14b-487d-a96d-8ff9ec0fbd4d 49349-290 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110714 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-291_19a079ab-99fc-4aff-a81b-247abbffccd5 49349-291 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET ORAL 20110608 ANDA ANDA077859 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-291_7014fd0c-3e9a-4e23-8611-862922b16703 49349-291 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET ORAL 20110608 ANDA ANDA077859 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-292_1a85af33-7a8b-46c7-9bcd-c33cefd0861f 49349-292 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20110608 ANDA ANDA076037 REMEDYREPACK INC. NEFAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 49349-293_db3ac8bc-149a-42bf-9cf5-eb75e7314a2c 49349-293 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20110608 ANDA ANDA076714 REMEDYREPACK INC. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-294_c3dcbec9-2c86-43a1-a89d-18fd149f5174 49349-294 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20110608 ANDA ANDA078216 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-295_7ff577af-7041-44d5-9147-741eef4742fb 49349-295 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110822 ANDA ANDA077955 REMEDYREPACK INC. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49349-296_d6fa3289-4220-4146-bb8f-6c2399b6767a 49349-296 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20110609 ANDA ANDA077836 REMEDYREPACK INC. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 49349-297_20c3e69a-7121-41d7-9153-a9fec33d64de 49349-297 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20130501 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 49349-297_91de4d60-ad66-4758-98d3-11834d899659 49349-297 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20130916 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 49349-298_9e20c35e-8d6a-4a3d-bbb4-43558c0ec1af 49349-298 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20110609 ANDA ANDA075317 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-300_3bd7e2ca-53e9-4e67-bf5c-18b59a254c2b 49349-300 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20110609 ANDA ANDA074480 REMEDYREPACK INC. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-301_cdb66dbf-4d83-4890-9a09-6b74feee05b5 49349-301 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20110609 ANDA ANDA076009 REMEDYREPACK INC. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-302_aace4e24-2372-4c1e-9b1a-49a651c91780 49349-302 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20110616 ANDA ANDA076211 REMEDYREPACK INC. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 49349-304_151c7d9e-55e5-43c5-aac7-abcc2f4f7536 49349-304 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid TABLET ORAL 20110616 ANDA ANDA073229 REMEDYREPACK INC. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-305_65d15ee7-5347-427f-9cf7-2f94ed902e17 49349-305 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride Paroxetine Hydrochloride TABLET ORAL 20110616 ANDA ANDA077584 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-306_d2baec4d-d51b-4760-9b02-e92abe0c2ba8 49349-306 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20110616 ANDA ANDA074532 REMEDYREPACK INC. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-307_8c14db20-a196-4ba1-9070-3addfc9106b0 49349-307 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20110617 ANDA ANDA078296 REMEDYREPACK INC. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-308_d8f99204-6565-49d6-978d-cc8066416ef4 49349-308 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride Paroxetine Hydrochloride TABLET ORAL 20110617 ANDA ANDA077584 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-310_b903bb8f-6ef6-4ef4-a61e-32c35e72880e 49349-310 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20110620 ANDA ANDA073556 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 49349-311_30ab4f43-c2aa-4586-851c-ddbcf3db88fc 49349-311 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20110620 ANDA ANDA064150 REMEDYREPACK INC. RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 49349-313_e611b54b-0e17-4893-827c-078a4ea59c69 49349-313 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110822 ANDA ANDA077900 REMEDYREPACK INC. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-314_ffedef0d-f34f-4335-a775-2ed989e3e336 49349-314 HUMAN PRESCRIPTION DRUG Methotrexate Sodium Methotrexate Sodium TABLET ORAL 20110620 ANDA ANDA081099 REMEDYREPACK INC. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 49349-315_57d2aa2a-8142-4e6a-91e2-2e2e7e7a2788 49349-315 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET ORAL 20110620 ANDA ANDA074787 REMEDYREPACK INC. LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-316_02c99fe6-4fd7-41ca-b38c-cd857c745577 49349-316 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110621 ANDA ANDA078402 REMEDYREPACK INC. LISINOPRIL 30 mg/1 49349-317_0a2e1791-90f9-4818-9747-7fbc8674fb8b 49349-317 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110621 ANDA ANDA075124 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-318_22b70123-685b-4ca2-933e-fc6888df3975 49349-318 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20110621 NDA NDA008678 REMEDYREPACK INC. ISONIAZID 100 mg/1 Antimycobacterial [EPC] 49349-319_c70af89c-e443-4844-b330-31d071129ccb 49349-319 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20110622 ANDA ANDA074869 REMEDYREPACK INC. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49349-320_e9867f8a-0200-4f9a-8bcb-550bf6dc67bf 49349-320 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20110713 ANDA ANDA074980 REMEDYREPACK INC. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-321_8230fdbe-281e-4e34-9bc3-90ebe8233766 49349-321 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 20130411 NDA NDA020634 REMEDYREPACK INC. LEVOFLOXACIN 250 mg/1 49349-322_6f5de9af-9dc3-4518-8d89-93acbbd63bd2 49349-322 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET ORAL 20110822 ANDA ANDA076502 REMEDYREPACK INC. FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 49349-326_26c1b5f7-52ae-4a2d-9331-06127d8a28f9 49349-326 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110622 ANDA ANDA076752 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-327_f54966dd-bdbe-4da5-add9-bdfc76de72e2 49349-327 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20130423 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 49349-328_a3275163-499a-44c2-8788-bc7eb13b1bcd 49349-328 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20110622 ANDA ANDA077836 REMEDYREPACK INC. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 49349-328_ba9814dd-0d42-4d71-9647-f382d212918b 49349-328 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20130911 ANDA ANDA077836 REMEDYREPACK INC. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 49349-330_f8d714f6-ff1b-4b29-b8ba-49d1b454c044 49349-330 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20110627 ANDA ANDA077662 REMEDYREPACK INC. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-331_21c20b2f-e77b-40c3-8919-ca66677d51f9 49349-331 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20110627 ANDA ANDA075078 REMEDYREPACK INC. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-332_608704e1-fa5a-4373-9e89-8a034843f25c 49349-332 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20110627 ANDA ANDA065144 REMEDYREPACK INC. CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 49349-334_4b922ea6-bcb9-4722-8ee4-fb91294c76e2 49349-334 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110627 ANDA ANDA076752 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-335_27426d1b-c786-490b-bf53-0c11c957bbf4 49349-335 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110713 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-336_a2c31fcd-b5f6-4928-8eae-93cace484848 49349-336 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110713 ANDA ANDA077877 REMEDYREPACK INC. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-337_a333e223-54e3-46b2-b2ca-1a0d233fef53 49349-337 HUMAN PRESCRIPTION DRUG CYMBALTA CYMBALTA CAPSULE, DELAYED RELEASE ORAL 20101223 NDA NDA021427 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-338_41d03127-9784-46a7-8b8f-ad4beb464a1c 49349-338 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20110627 ANDA ANDA074305 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49349-339_15e539a3-4ad3-413e-827b-bdb1ee1d4434 49349-339 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110627 ANDA ANDA078010 REMEDYREPACK INC. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 49349-339_585e537b-d3f1-4ec7-b7ad-f8215bdd2816 49349-339 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20130731 ANDA ANDA078010 REMEDYREPACK INC. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 49349-340_744e58d4-a2c1-4299-91f5-70b9c7366c1c 49349-340 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET ORAL 20110628 ANDA ANDA075584 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49349-341_1f2a57e9-721d-4fd3-a7ac-f1ff3e5b4407 49349-341 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110628 ANDA ANDA078250 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-344_65853461-7b8a-4683-991a-1c920185f4ba 49349-344 HUMAN PRESCRIPTION DRUG Pyrazinamide Pyrazinamide TABLET ORAL 20110630 ANDA ANDA081319 REMEDYREPACK INC. PYRAZINAMIDE 500 mg/1 Antimycobacterial [EPC] 49349-345_8d519e4c-321a-4807-9db5-310911819039 49349-345 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20110518 ANDA ANDA090377 REMEDYREPACK INC. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-346_3e694b96-9806-4ba8-afd0-0e82930c4030 49349-346 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20110630 ANDA ANDA040301 REMEDYREPACK INC. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-347_5b869e21-f28b-492d-9646-d088bffdd213 49349-347 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET ORAL 20110630 ANDA ANDA040185 REMEDYREPACK INC. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 49349-348_8ce58130-6319-4f23-89a7-c809f1ce018b 49349-348 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20110701 ANDA ANDA075317 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-349_6b26b92d-8323-46a1-95fa-03bd4d742f4c 49349-349 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110823 ANDA ANDA076708 REMEDYREPACK INC. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-350_48e60226-3e70-4e72-b743-d1ee7f7337ae 49349-350 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20130726 ANDA ANDA078459 REMEDYREPACK INC. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-350_b1d12db8-d543-4d94-8d4a-159b61069d4b 49349-350 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20110707 ANDA ANDA078459 REMEDYREPACK INC. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-350_c082a13e-f4c6-4f4d-b586-38fa5272feb1 49349-350 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20130729 ANDA ANDA078459 REMEDYREPACK INC. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-351_dc117dcf-b275-4ea7-93c6-7533d759c0b0 49349-351 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20110707 ANDA ANDA076921 REMEDYREPACK INC. MIRTAZAPINE 30 mg/1 49349-352_6907b85a-21c1-47e4-b43b-e9e833aafbef 49349-352 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110708 ANDA ANDA076112 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-352_8f3f5d65-1eb7-4d06-8b56-2b023c385074 49349-352 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20130725 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-352_f74f474a-c0db-4bba-b2ea-63c356c9f48b 49349-352 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20130725 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-353_49ea87e2-81e4-4570-9230-175a1bbf1a46 49349-353 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20110708 ANDA ANDA065136 REMEDYREPACK INC. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 49349-354_74ff6d99-1936-43ea-af13-8f415e410ca5 49349-354 HUMAN PRESCRIPTION DRUG FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20101223 ANDA ANDA089804 REMEDYREPACK INC. FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 49349-355_0b0fc9d5-d558-4f92-869b-67da2a2d3c11 49349-355 HUMAN PRESCRIPTION DRUG Dilantin Phenytoin Sodium CAPSULE ORAL 20110708 ANDA ANDA084349 REMEDYREPACK INC. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-356_ae1538d3-cef3-4515-8b11-b80dbfa1e45f 49349-356 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20110708 ANDA ANDA077691 REMEDYREPACK INC. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-357_4bcfa732-1481-4f8f-94b1-27c1b028a403 49349-357 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20110708 ANDA ANDA090118 REMEDYREPACK INC. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49349-358_d2f12857-3d09-459d-948a-1669ae58fdd2 49349-358 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20110708 ANDA ANDA040625 REMEDYREPACK INC. FOLIC ACID 1 mg/1 49349-359_97647c02-d6a7-4700-a164-743ea79e9867 49349-359 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20110708 ANDA ANDA075694 REMEDYREPACK INC. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-360_d03f3982-e2ab-473f-808f-8153fbb4613d 49349-360 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20110708 ANDA ANDA074388 REMEDYREPACK INC. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49349-361_d4378dbc-3714-4967-b9ac-f1cfd60b6dd4 49349-361 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20130521 ANDA ANDA077877 REMEDYREPACK INC. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-361_ed221118-8948-4dc2-9064-cd26c55b89b4 49349-361 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110708 ANDA ANDA077877 REMEDYREPACK INC. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-362_299d8132-2fe0-4aa9-bee1-2b41c2e5240e 49349-362 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20130423 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 49349-363_272a9765-334a-4af9-aceb-a98a5eed5385 49349-363 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20110711 ANDA ANDA065061 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 49349-364_a73c8c37-fae2-47e4-8e3f-81fed505e5fa 49349-364 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride Paroxetine Hydrochloride TABLET ORAL 20110711 ANDA ANDA077584 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-365_78b433d9-54dd-443d-a820-cddb711c2d88 49349-365 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110822 ANDA ANDA079153 REMEDYREPACK INC. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-367_27b48ebb-7cb7-4b2a-ae89-91aec123e9e7 49349-367 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20110711 ANDA ANDA075694 REMEDYREPACK INC. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-368_3dadff4c-3d5a-472f-86aa-15af9d0e7470 49349-368 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110523 ANDA ANDA076752 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-369_0c8abb42-085b-4b7f-afaa-848b6fa608c0 49349-369 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET ORAL 20110711 ANDA ANDA089583 REMEDYREPACK INC. FLUPHENAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 49349-370_da57e1f4-9116-435d-a29d-e76c98d632dc 49349-370 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110712 ANDA ANDA076112 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-371_973e6a14-f30a-4501-b058-96e8e5af334d 49349-371 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20110712 ANDA ANDA076336 REMEDYREPACK INC. MIRTAZAPINE 30 mg/1 49349-372_8b3bc37d-99d8-4a6c-ae68-d0e1b5e76331 49349-372 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20110823 ANDA ANDA077927 REMEDYREPACK INC. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-372_9b9e89e5-7363-4a15-9b8b-00bf987b2bbc 49349-372 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20141230 ANDA ANDA077927 REMEDYREPACK INC. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-374_1c98005d-a786-4b1e-a2df-28919b933614 49349-374 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110713 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 2.5 mg/1 49349-375_d6996222-9469-41cd-9a77-968adca7485a 49349-375 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20120823 ANDA ANDA075382 REMEDYREPACK INC. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-375_e001f92e-79a6-4e1f-b0bb-9bf2baeb763d 49349-375 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20110714 ANDA ANDA075382 REMEDYREPACK INC. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-376_bd74276a-296f-4ddd-8c09-e16067bc8377 49349-376 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110714 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-377_0cf95971-9184-4763-8e70-a18f661ea5fe 49349-377 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20110714 ANDA ANDA075382 REMEDYREPACK INC. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-378_6f250800-2d15-411d-bc1d-dba379735571 49349-378 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET ORAL 20110714 ANDA ANDA074246 REMEDYREPACK INC. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 49349-379_afc962df-fbfc-4c52-ac6c-6e0643e5c963 49349-379 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 20110714 ANDA ANDA075597 REMEDYREPACK INC. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 49349-381_470ca5f2-c719-429a-8a91-2535573deb15 49349-381 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110822 ANDA ANDA078500 REMEDYREPACK INC. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49349-382_da2596a3-4396-4408-857a-d3bdeba9fca5 49349-382 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20110715 ANDA ANDA076285 REMEDYREPACK INC. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-383_37d5e54c-5be6-49a5-ac4b-5fcfabbb7df5 49349-383 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20110715 ANDA ANDA076958 REMEDYREPACK INC. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49349-385_1bbe3026-335e-4716-b018-1ebb11b4b46d 49349-385 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110715 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-387_c855ec4a-ad76-487b-9603-b119cfebb648 49349-387 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20110718 ANDA ANDA077927 REMEDYREPACK INC. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-388_38b29820-b516-4b38-9244-fde6bdb33177 49349-388 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20110718 ANDA ANDA076921 REMEDYREPACK INC. MIRTAZAPINE 15 mg/1 49349-388_d8fc6930-95cf-4118-b870-9e4a2e51d972 49349-388 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20130927 ANDA ANDA076921 REMEDYREPACK INC. MIRTAZAPINE 15 mg/1 49349-389_11e5c0bd-3f7b-499d-9f1a-a3a01c4a622b 49349-389 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20110719 ANDA ANDA077836 REMEDYREPACK INC. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 49349-391_63227d34-f7fd-4f9c-b2de-2669db37cdaa 49349-391 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110719 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 30 mg/1 49349-392_bec39ed7-2b18-4b21-91ff-7e3fd515e7bc 49349-392 HUMAN PRESCRIPTION DRUG Thiothixene Thiothixene CAPSULE ORAL 20110719 ANDA ANDA071530 REMEDYREPACK INC. THIOTHIXENE 10 mg/1 Typical Antipsychotic [EPC] 49349-393_7b38b400-38cb-4e73-bfed-7ec3ec397a96 49349-393 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20110719 NDA NDA008678 REMEDYREPACK INC. ISONIAZID 100 mg/1 Antimycobacterial [EPC] 49349-395_bd16f907-55de-4da1-a544-ab9cbb6be788 49349-395 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110719 ANDA ANDA079153 REMEDYREPACK INC. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-396_ddf702c9-ee5a-4e78-a908-7cc7c6eefd24 49349-396 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20110718 ANDA ANDA076921 REMEDYREPACK INC. MIRTAZAPINE 45 mg/1 49349-398_c14ecfee-7a28-4305-9f7e-86817a637c0a 49349-398 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110719 ANDA ANDA078428 REMEDYREPACK INC. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-399_75e035e3-4e11-462e-b4c8-9bf3335f46d4 49349-399 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20110720 ANDA ANDA077567 REMEDYREPACK INC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-400_5b8cd83e-c462-4365-aadd-b4fb829fbaf0 49349-400 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110914 ANDA ANDA040907 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-400_80cfee51-db0c-44fe-97a3-e98d338d7f0a 49349-400 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110720 ANDA ANDA040907 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-401_79fdf8de-5bcf-4f71-9e50-e47e7d8a28ce 49349-401 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20110720 ANDA ANDA078938 REMEDYREPACK INC. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-402_3817c7b4-395e-4c2b-8ca4-d0107bf13f2a 49349-402 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110720 ANDA ANDA079153 REMEDYREPACK INC. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-405_9cabfcfa-1d18-473b-94cb-40f9e96364ec 49349-405 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20110720 ANDA ANDA077296 REMEDYREPACK INC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-406_eb086910-3ef8-4806-b44d-a1f13ef3e542 49349-406 HUMAN PRESCRIPTION DRUG Methotrexate Sodium Methotrexate Sodium TABLET ORAL 20110721 ANDA ANDA081099 REMEDYREPACK INC. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 49349-407_54873c63-bdf7-4911-bca0-d64f29f4bd50 49349-407 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride Paroxetine Hydrochloride TABLET ORAL 20110721 ANDA ANDA078406 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-408_de300111-1f28-4325-a10b-5f1f544b5ed5 49349-408 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20110721 NDA NDA018333 REMEDYREPACK INC. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 49349-409_2afe2fb2-0d6a-46a7-b6f5-080ba18e0c99 49349-409 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20110721 ANDA ANDA078619 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-410_8b197bac-2082-4e3d-9c1f-17d6ef63cd8a 49349-410 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20110721 ANDA ANDA077064 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-411_212fa0be-7997-40ca-91a4-d95e75a356c7 49349-411 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20110721 ANDA ANDA078705 REMEDYREPACK INC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-413_5db730e1-6ff4-45f5-91ba-ac09b4b54c41 49349-413 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20110722 ANDA ANDA076921 REMEDYREPACK INC. MIRTAZAPINE 45 mg/1 49349-414_2925eb51-88de-4d73-9019-8c324e0b2865 49349-414 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20110722 ANDA ANDA077031 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-415_74432957-cb2f-492f-b8ca-110c81f1c3a4 49349-415 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110722 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-416_ee60c32f-1bc6-4769-aa09-3ecfdf6c628e 49349-416 HUMAN PRESCRIPTION DRUG Thiothixene Thiothixene CAPSULE ORAL 20110722 ANDA ANDA071529 REMEDYREPACK INC. THIOTHIXENE 5 mg/1 Typical Antipsychotic [EPC] 49349-417_ba472ece-a65a-416d-aa8a-0f05e01223bb 49349-417 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110725 ANDA ANDA078428 REMEDYREPACK INC. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-419_b9e327d9-af86-456f-9031-e818379fa41d 49349-419 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20110725 ANDA ANDA076285 REMEDYREPACK INC. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-420_05f1809c-40c8-4cc0-81d7-cea265a19c87 49349-420 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110728 ANDA ANDA078494 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-421_c7ab9522-5e16-4998-a7c4-f0594365ecfd 49349-421 HUMAN PRESCRIPTION DRUG BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE TABLET ORAL 20101207 ANDA ANDA090360 REMEDYREPACK INC. BUPRENORPHINE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 49349-423_18380955-ac8e-4120-90af-c7c4e8854629 49349-423 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20110725 ANDA ANDA077031 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-424_3c35e6c8-8096-4099-869e-298b3ec2a403 49349-424 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110725 ANDA ANDA074330 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-425_acd22561-d9c5-4ed9-9b54-a385928c8f70 49349-425 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20110728 ANDA ANDA077031 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-426_db386cb2-314f-4d43-bd67-ecd65ef53850 49349-426 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20110728 ANDA ANDA075317 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-427_b45729ad-804b-43b3-9e0a-28bb37dee77c 49349-427 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20110728 ANDA ANDA077525 REMEDYREPACK INC. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-428_ff63d334-6720-4438-9e05-5190dcd64177 49349-428 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110728 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-429_61556ddb-c680-4bdc-b684-2b4829720775 49349-429 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20110728 ANDA ANDA074946 REMEDYREPACK INC. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-430_84979dd5-0ad4-4e47-a8c3-88b55363491f 49349-430 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, FILM COATED ORAL 20130410 NDA NDA022145 REMEDYREPACK INC. RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] 49349-430_e2b78ce7-a387-4a29-9c78-053c71bfd86f 49349-430 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, FILM COATED ORAL 20130410 NDA NDA022145 REMEDYREPACK INC. RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] 49349-431_830f0c9f-261a-4798-82fa-0e6b9f7cd491 49349-431 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET ORAL 20110729 ANDA ANDA075593 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-432_4785da86-912f-48e5-9508-294a1137e35a 49349-432 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20110729 ANDA ANDA075317 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-434_0812c693-de62-4fc7-a06f-9337212c84a1 49349-434 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20110729 ANDA ANDA070975 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 49349-434_6d83defc-fda9-49b0-818b-6e08edc762bd 49349-434 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20111116 ANDA ANDA070975 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 49349-436_a33bf9b7-3bd6-4ae3-b8f9-fdf3de854d9d 49349-436 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20110801 ANDA ANDA076285 REMEDYREPACK INC. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-438_c0513415-abae-4e8e-99f5-808ec4689cd0 49349-438 HUMAN PRESCRIPTION DRUG Metoprolol Tartate Metoprolol Tartrate TABLET ORAL 20110801 ANDA ANDA074217 REMEDYREPACK INC. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-440_90aaef48-17dd-45eb-9753-99fa5ec56c9d 49349-440 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20110801 ANDA ANDA075382 REMEDYREPACK INC. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-441_400a1f94-ba0f-4acc-8967-1e7575c3bf3a 49349-441 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20111116 ANDA ANDA040156 REMEDYREPACK INC. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 49349-441_dc4cc93f-d0ae-46fd-baed-3ec02ef26070 49349-441 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride CAPSULE ORAL 20110803 ANDA ANDA040156 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 49349-442_89adfc3d-7404-4552-a065-4b03cea18d2b 49349-442 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20110801 ANDA ANDA075659 REMEDYREPACK INC. ISOSORBIDE DINITRATE 5 mg/1 49349-443_4874a5b8-5a80-4f93-bf9c-e16de5ee6983 49349-443 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20110801 ANDA ANDA084769 REMEDYREPACK INC. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49349-445_98ec83f7-e6cc-481b-bbe8-b9c89416e883 49349-445 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE TABLET ORAL 20120824 ANDA ANDA070974 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 49349-445_a5e9f740-03ec-41e7-8bc6-515fde577089 49349-445 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20110801 ANDA ANDA070974 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 49349-446_105c62be-bed5-47a4-ae82-d14fa9dc50ff 49349-446 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET ORAL 20110801 ANDA ANDA075095 REMEDYREPACK INC. ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] 49349-447_c1c05852-b948-4c2e-a7be-d0250b8411bb 49349-447 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20110803 ANDA ANDA064150 REMEDYREPACK INC. RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 49349-448_5a9efd9e-9185-487c-8c6a-5543cbb5d433 49349-448 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20110804 ANDA ANDA070175 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-449_5941a972-18d7-4935-a5f6-b73a36a0a5b5 49349-449 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20110804 ANDA ANDA075659 REMEDYREPACK INC. CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49349-451_e606e569-414e-4a37-9c28-accad6b7bc6a 49349-451 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20110804 ANDA ANDA076921 REMEDYREPACK INC. MIRTAZAPINE 15 mg/1 49349-452_49c516ee-cdde-4bde-a344-14e142ff5975 49349-452 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110804 ANDA ANDA076565 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-453_a4744892-ed4f-4af7-9cbe-0f3568dfa504 49349-453 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET ORAL 20110804 ANDA ANDA076089 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-454_58264d05-500d-430c-a48b-f9a10fdb98d3 49349-454 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20110805 ANDA ANDA070976 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 49349-456_3ce79fac-3f36-4238-b461-94d12b325109 49349-456 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110805 ANDA ANDA076565 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-459_154ee209-8d94-4de8-b66c-36d2029434bb 49349-459 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET ORAL 20110808 ANDA ANDA070995 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-461_33b77d0a-a5d8-44f6-841f-87c07889b5c1 49349-461 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20101216 ANDA ANDA072265 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 49349-462_a6810aa0-d854-4cf6-919f-84c8a071ccf1 49349-462 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20110808 ANDA ANDA077031 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-463_8bf19f7f-1b8e-4e67-b8ed-1d80b22fda69 49349-463 HUMAN PRESCRIPTION DRUG DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE ORAL 20101223 ANDA ANDA070793 REMEDYREPACK INC. DOXEPIN HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 49349-465_d8510e4f-8889-4a4d-af2c-5e25e7a85deb 49349-465 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20101223 ANDA ANDA070790 REMEDYREPACK INC. DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 49349-466_d41301e0-cd2b-45c3-b2fb-5f3a43f9da50 49349-466 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20110810 ANDA ANDA080600 REMEDYREPACK INC. FOLIC ACID 1 mg/1 49349-467_7b175e97-5ed6-4a08-864d-8e72e6b53ad3 49349-467 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110810 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-468_31aff22e-f63e-4219-8355-6530d265c6f6 49349-468 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20110810 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-469_96c1a609-d1e7-4e8f-bd30-43cc2b2576fa 49349-469 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride METFORMIN HYDROCHLORIDE TABLET ORAL 20120827 ANDA ANDA077064 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-469_f5adf469-6215-4b6c-b74c-0c5b7ab34267 49349-469 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20110810 ANDA ANDA077064 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-470_1126a08f-59fe-4540-9c43-40c0822518fd 49349-470 HUMAN PRESCRIPTION DRUG Metfomin Hydrochloride Metformin Hydrochloride TABLET ORAL 20110810 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-471_1ec0f702-6196-46bc-82eb-356f4b8103e4 49349-471 HUMAN PRESCRIPTION DRUG EXTENDED PHENYTOIN SODIUM EXTENDED PHENYTOIN SODIUM CAPSULE ORAL 20130624 ANDA ANDA040732 REMEDYREPACK INC. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-471_a49bdc21-c13e-4b35-83cb-3813550aaf89 49349-471 HUMAN PRESCRIPTION DRUG EXTENDED PHENYTOIN SODIUM EXTENDED PHENYTOIN SODIUM CAPSULE ORAL 20130409 ANDA ANDA040732 REMEDYREPACK INC. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-471_aebf7d02-78d8-4ec9-9ce5-82d5ca2c251a 49349-471 HUMAN PRESCRIPTION DRUG EXTENDED PHENYTOIN SODIUM EXTENDED PHENYTOIN SODIUM CAPSULE ORAL 20130409 ANDA ANDA040732 REMEDYREPACK INC. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-472_19086156-4c55-4266-a3c9-16557cd9bd01 49349-472 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20110328 ANDA ANDA077864 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-472_8d19c1ba-d394-4aa0-85e2-6c68cc4bc250 49349-472 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20110810 ANDA ANDA077397 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-473_8d0b7918-c956-4872-8496-311ac25217ec 49349-473 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110810 ANDA ANDA077877 REMEDYREPACK INC. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-474_9e3a3716-a226-486f-b287-ebf3feb8dc45 49349-474 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110810 ANDA ANDA077877 REMEDYREPACK INC. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-476_9d4a1707-088c-46a9-92e2-273c9e2314cd 49349-476 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET ORAL 20110811 ANDA ANDA077824 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 49349-477_d01fe66b-5aac-47d6-b64e-0601cdee8cb5 49349-477 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20110811 ANDA ANDA084768 REMEDYREPACK INC. CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 49349-478_786c55c9-0065-4afe-bb01-b4225487e931 49349-478 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110811 ANDA ANDA076112 REMEDYREPACK INC. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-478_a481ddbe-686e-4e91-b1b6-d4521c13a7dc 49349-478 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20120829 ANDA ANDA076112 REMEDYREPACK INC. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-479_0d2997b3-8c4b-4a08-8963-4a08defd87ab 49349-479 HUMAN PRESCRIPTION DRUG FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE ORAL 20101221 ANDA ANDA078619 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-480_29e25501-a9fd-4f66-a4ff-2e6e821c7e87 49349-480 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride CAPSULE ORAL 20130726 ANDA ANDA040156 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 49349-480_9768d85b-4d63-4be3-827a-ff07d5f5e3fb 49349-480 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride CAPSULE ORAL 20130726 ANDA ANDA040156 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 49349-480_e880def1-fc17-4c0a-ad40-bac79fcad382 49349-480 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride CAPSULE ORAL 20110812 ANDA ANDA040156 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 49349-481_8882fe7a-50d2-4f3a-a4ea-c2a3039ba24d 49349-481 HUMAN PRESCRIPTION DRUG Loxapine Succinate Loxapine Succinate CAPSULE ORAL 20110815 ANDA ANDA072206 REMEDYREPACK INC. LOXAPINE SUCCINATE 25 mg/1 49349-482_ca738366-18ca-4052-8d0d-1428d71ec70b 49349-482 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20110816 ANDA ANDA075317 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-483_f709598d-e659-4621-b110-c728e4e16651 49349-483 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20141106 ANDA ANDA078619 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-484_59ede30a-4be2-447a-9429-78c513ea7dad 49349-484 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110817 NDA AUTHORIZED GENERIC NDA020939 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-486_d89659c8-7e2c-4f5b-a37e-27bad4116114 49349-486 HUMAN PRESCRIPTION DRUG Ribasphere RIBAVIRIN TABLET ORAL 20110818 ANDA ANDA077456 REMEDYREPACK INC. RIBAVIRIN 400 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 49349-493_8a1b01f3-5af6-4eb1-8ba3-d9bcd92fd99f 49349-493 HUMAN PRESCRIPTION DRUG Thiothixene Thiothixene CAPSULE ORAL 20110817 ANDA ANDA071093 REMEDYREPACK INC. THIOTHIXENE 2 mg/1 Typical Antipsychotic [EPC] 49349-494_3fe6dc08-bd7b-4485-aa40-ced0789aaed9 49349-494 HUMAN PRESCRIPTION DRUG Asacol MESALAMINE TABLET ORAL 20110817 NDA NDA019651 REMEDYREPACK INC. MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 49349-495_9b5714c7-e0e5-473b-8462-cf911fd5c9e6 49349-495 HUMAN PRESCRIPTION DRUG Dilantin PHENYTOIN TABLET, CHEWABLE ORAL 20110818 ANDA ANDA084427 REMEDYREPACK INC. PHENYTOIN 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-496_1124762a-384a-4d25-942e-55535d21d344 49349-496 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE ORAL 20130725 ANDA ANDA076570 REMEDYREPACK INC. TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 49349-496_a4e55321-8196-407c-83d5-830ec23d651d 49349-496 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE ORAL 20110818 ANDA ANDA076570 REMEDYREPACK INC. TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 49349-496_b6077dbf-ada4-4453-8160-57e09e9f4b3b 49349-496 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE ORAL 20130927 ANDA ANDA076570 REMEDYREPACK INC. TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 49349-496_ed700ef1-a802-4673-ae82-f7c8bedd6921 49349-496 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE ORAL 20131231 ANDA ANDA076570 REMEDYREPACK INC. TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 49349-497_cdb19bb3-c1cf-4582-9b1d-3093b79c2fe2 49349-497 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET ORAL 20110818 ANDA ANDA075584 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49349-498_ca7396c9-95a5-4272-879e-fcb620824143 49349-498 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20110818 ANDA ANDA078069 REMEDYREPACK INC. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-501_1194889a-4ac6-42f0-bc88-953551db78f2 49349-501 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20130301 ANDA ANDA074132 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 49349-507_25bd07a0-c88d-498b-8aff-a466a679ac15 49349-507 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20130301 ANDA ANDA075961 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-509_3924bc01-8331-4a9b-b46e-322696a8d6a0 49349-509 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110914 ANDA ANDA078500 REMEDYREPACK INC. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49349-510_2c0bb625-fea3-4619-8b7b-004910da6ced 49349-510 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110914 ANDA ANDA078500 REMEDYREPACK INC. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49349-512_1af644b2-3178-452f-af56-23e5caaf7193 49349-512 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20110915 ANDA ANDA077580 REMEDYREPACK INC. HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] 49349-513_7fa0704e-e3b4-4892-b8b0-7b40c7684193 49349-513 HUMAN PRESCRIPTION DRUG Loxapine Succinate Loxapine Succinate CAPSULE ORAL 20110915 ANDA ANDA072204 REMEDYREPACK INC. LOXAPINE SUCCINATE 5 mg/1 49349-514_3e3b597e-4ff0-493a-947d-49c420696fb2 49349-514 HUMAN PRESCRIPTION DRUG Loxapine Succinate Loxapine Succinate CAPSULE ORAL 20110915 ANDA ANDA072062 REMEDYREPACK INC. LOXAPINE SUCCINATE 50 mg/1 49349-515_10d6a44c-b148-4b72-bc92-153e1f9739fd 49349-515 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 20110919 ANDA ANDA071588 REMEDYREPACK INC. DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 49349-516_354aa7e0-8706-4f52-b53c-ffd5027247fc 49349-516 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20130501 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 49349-517_3045e1aa-e51b-4fc3-a59f-568a96850db8 49349-517 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20130521 ANDA ANDA077031 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-517_427c8613-956a-4b7d-bd64-a4b13a55f22c 49349-517 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20130304 ANDA ANDA077031 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-518_a6e1f01e-7c3b-4e02-ad20-8585726270cd 49349-518 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20110920 ANDA ANDA078619 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-519_19e0f743-5389-45a9-8163-cffd7dfb70bf 49349-519 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20110920 ANDA ANDA072264 REMEDYREPACK INC. BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 49349-520_c31b7233-4943-4f52-9cee-54f073515a1e 49349-520 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 20110920 ANDA ANDA084937 REMEDYREPACK INC. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 49349-521_4943ec5e-ff0d-4d5c-9fdc-85f7fe859689 49349-521 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20130405 ANDA ANDA074556 REMEDYREPACK INC. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-521_9e760cc1-b2ce-4ccc-be45-ec615bacf1fe 49349-521 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20130403 ANDA ANDA074556 REMEDYREPACK INC. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-521_c728ce6f-e584-4705-b703-9645bb8bb49f 49349-521 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20110920 ANDA ANDA074556 REMEDYREPACK INC. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-522_5550880a-803c-42b5-a935-71904a8db023 49349-522 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20110920 ANDA ANDA040337 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 49349-523_8dc067ee-5ec2-4c29-9fc4-d1be1b7dba9b 49349-523 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20110920 ANDA ANDA077987 REMEDYREPACK INC. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-523_9082361f-62b2-42b2-b8e7-a7d31fc289e0 49349-523 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20140512 ANDA ANDA077987 REMEDYREPACK INC. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-524_3d820163-af09-479f-9d6e-c0bd2fad9600 49349-524 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20110921 ANDA ANDA073553 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 49349-525_f2b0b417-061d-421a-9f86-9561746c8496 49349-525 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 20110921 ANDA ANDA083745 REMEDYREPACK INC. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 49349-527_c2d24521-383b-400c-b451-8ec50089b462 49349-527 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110921 ANDA ANDA077878 REMEDYREPACK INC. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 49349-528_d953820c-05d1-419b-9fff-909078ff2d0e 49349-528 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20110921 ANDA ANDA076921 REMEDYREPACK INC. MIRTAZAPINE 30 mg/1 49349-530_343d29b7-69ca-4ef9-8ac9-3718fd800309 49349-530 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20110922 ANDA ANDA040537 REMEDYREPACK INC. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 49349-531_6faa5b9e-9eb8-44b2-a522-34a21975bff5 49349-531 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20110923 ANDA ANDA075828 REMEDYREPACK INC. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-533_df9b4bf2-8a82-46eb-b0d6-c539d049e03e 49349-533 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20110923 ANDA ANDA077525 REMEDYREPACK INC. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-534_7291bbf0-99b3-466e-a9d0-93e3e4ae05e9 49349-534 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20110926 ANDA ANDA074726 REMEDYREPACK INC. POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 49349-536_d60b39ba-35a0-4c94-9ce7-e7430e6513d4 49349-536 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110926 ANDA ANDA078010 REMEDYREPACK INC. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 49349-537_c2e56020-fb78-4a7b-ae7b-ade2bd24277e 49349-537 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20110926 ANDA ANDA074223 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49349-538_0a1a4c15-4bd3-49b3-aa68-19500cb48ba6 49349-538 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110519 ANDA ANDA078428 REMEDYREPACK INC. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-540_ee1ffe9a-e02a-4733-a24e-50fac3a3ec2f 49349-540 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET ORAL 20110927 ANDA ANDA074787 REMEDYREPACK INC. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-541_863e8a76-de60-4428-9dde-80cc561bb6c5 49349-541 HUMAN PRESCRIPTION DRUG Tramadol Hydrchloride Tramadol Hydrochloride TABLET ORAL 20130725 ANDA ANDA076003 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 49349-541_fdcf0725-e425-455d-831d-3d0d7f9932b8 49349-541 HUMAN PRESCRIPTION DRUG Tramadol Hydrchloride Tramadol Hydrochloride TABLET ORAL 20110928 ANDA ANDA076003 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 49349-542_1df07f81-97d9-41f1-bc6b-6eddd42699c8 49349-542 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20110928 ANDA ANDA040416 REMEDYREPACK INC. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-543_572450d6-8b0a-4307-827f-063a0eed4b73 49349-543 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20110928 ANDA ANDA040416 REMEDYREPACK INC. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-544_77a90b06-7697-4043-8758-52bdbdadb90b 49349-544 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20130521 ANDA ANDA077877 REMEDYREPACK INC. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-544_f43b46a5-fdd2-45bd-acc2-0af2923c78bc 49349-544 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110929 ANDA ANDA077877 REMEDYREPACK INC. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-545_1e8fd61d-f9be-459b-aa31-1ecf1254f256 49349-545 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20110929 ANDA ANDA071655 REMEDYREPACK INC. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 49349-546_f09bb1f9-61f3-4b29-a248-7771fc99fee2 49349-546 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20130305 ANDA ANDA075786 REMEDYREPACK INC. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 49349-547_30dfbe23-f198-410f-8779-03158b90f1d9 49349-547 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130927 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-547_c4b29030-9532-4508-b828-222e82eb873f 49349-547 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110519 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 5 mg/1 49349-548_5584a89e-318a-4042-beb4-8009ba684bba 49349-548 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131204 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-548_60f2f22d-756b-40cb-ade3-b19e90dd3c31 49349-548 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130409 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-548_63614d49-1bd4-4814-99e6-8f53f5d4fbb7 49349-548 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130624 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-548_b0ac7be1-cf28-46d3-8308-ec07a482dd7c 49349-548 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130404 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-548_b0c29934-fa89-46b8-9720-0e78e273ca99 49349-548 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110929 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 20 mg/1 49349-549_4286d3a3-532d-4ae1-8059-fb76f3782f25 49349-549 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131205 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-549_9fde41d5-09d2-4bab-af5b-5771d7c836d5 49349-549 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110929 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 10 mg/1 49349-549_a4d7bbb6-492f-4bdb-ba40-11025d375e6e 49349-549 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130624 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-549_dffbf959-c905-4194-b2f8-0199ae8228d5 49349-549 HUMAN PRESCRIPTION DRUG Lisinopril LISINOPRIL TABLET ORAL 20120831 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-550_21189ead-9b76-45ae-bdbf-88dc09a440a5 49349-550 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130722 ANDA ANDA083677 REMEDYREPACK INC. PREDNISONE 20 mg/1 49349-550_4568c3cd-c832-4f0c-900f-379eab75682e 49349-550 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130726 ANDA ANDA083677 REMEDYREPACK INC. PREDNISONE 20 mg/1 49349-550_4f2a74cb-c209-48ed-b9c7-f20e55ea992a 49349-550 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20120301 ANDA ANDA083677 REMEDYREPACK INC. PREDNISONE 20 mg/1 49349-550_55592be0-0aaa-4542-a3c2-086505bc98d1 49349-550 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140108 ANDA ANDA083677 REMEDYREPACK INC. PREDNISONE 20 mg/1 49349-550_759d7746-21b0-43c1-b743-5fe0009e1b8d 49349-550 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130726 ANDA ANDA083677 REMEDYREPACK INC. PREDNISONE 20 mg/1 49349-551_3ba656d8-bc56-4c5e-ac14-f4f6aabd6946 49349-551 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET ORAL 20111003 ANDA ANDA077824 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 49349-554_c779a3f5-cce7-4708-a714-3d3919c26dc9 49349-554 HUMAN PRESCRIPTION DRUG BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE TABLET ORAL 20101207 ANDA ANDA078633 REMEDYREPACK INC. BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 49349-555_eda3b853-667f-4154-97ac-086940547f4f 49349-555 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111003 ANDA ANDA040145 REMEDYREPACK INC. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-556_4d8b39ae-76aa-4903-8a67-52e7068feacf 49349-556 HUMAN PRESCRIPTION DRUG Fludrocortisone Acetate Fludrocortisone Acetate TABLET ORAL 20111003 ANDA ANDA040425 REMEDYREPACK INC. FLUDROCORTISONE ACETATE .1 mg/1 49349-557_381ed2a4-ea2d-4ba1-9891-38f5c6d9e433 49349-557 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET ORAL 20111003 ANDA ANDA074185 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-557_b804ba3e-3111-40c7-be31-85bcabd2802f 49349-557 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE TABLET ORAL 20120831 ANDA ANDA074185 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-559_48c13a89-80f6-4d28-8c74-a91b1028da07 49349-559 HUMAN PRESCRIPTION DRUG Prandin Repaglinide TABLET ORAL 20111004 NDA NDA020741 REMEDYREPACK INC. REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 49349-560_4e198ff3-a676-473c-9fda-a028ef7331b4 49349-560 HUMAN PRESCRIPTION DRUG PYRIDOSTIGMINE BROMIDE PYRIDOSTIGMINE BROMIDE TABLET ORAL 20130403 ANDA ANDA040502 REMEDYREPACK INC. PYRIDOSTIGMINE BROMIDE 60 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 49349-560_aa3c21d2-3080-4feb-ab25-b07dff88d365 49349-560 HUMAN PRESCRIPTION DRUG Pyridostigmine Bromide Pyridostigmine Bromide TABLET ORAL 20111004 ANDA ANDA040502 REMEDYREPACK INC. PYRIDOSTIGMINE BROMIDE 60 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 49349-561_2d9e356c-041b-4e3f-9b11-551da2ddc31a 49349-561 HUMAN PRESCRIPTION DRUG Pentasa mesalamine CAPSULE ORAL 20130319 NDA NDA020049 REMEDYREPACK INC. MESALAMINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 49349-561_600dc302-c407-42bb-b720-5eaae41850da 49349-561 HUMAN PRESCRIPTION DRUG Pentasa Mesalamine CAPSULE ORAL 20111004 NDA NDA020049 REMEDYREPACK INC. MESALAMINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 49349-562_444f2d56-562a-429c-8713-59db0c09a98c 49349-562 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20111005 ANDA ANDA075483 REMEDYREPACK INC. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 49349-562_59ad42d2-2974-40dc-a588-6805297bcf2b 49349-562 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20130329 ANDA ANDA075483 REMEDYREPACK INC. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 49349-563_5df29e02-59ba-4e33-a9eb-d141ec585f86 49349-563 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET ORAL 20131230 ANDA ANDA040750 REMEDYREPACK INC. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 49349-563_62dfe8de-b449-4966-8be1-49bbcd7b03f5 49349-563 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20111007 ANDA ANDA040750 REMEDYREPACK INC. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 49349-564_376ef0bf-b594-43e2-a03d-94167b57a37f 49349-564 HUMAN PRESCRIPTION DRUG Medrol Methylprednisolone TABLET ORAL 20111011 NDA NDA011153 REMEDYREPACK INC. METHYLPREDNISOLONE 32 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49349-565_06f3caab-c7cb-47df-b2b8-7d88cf1912fa 49349-565 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, CHEWABLE ORAL 20130301 ANDA ANDA075687 REMEDYREPACK INC. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 49349-566_9ce964ec-3c28-4ad6-ad30-90a9107d0f9a 49349-566 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20111010 ANDA ANDA018569 REMEDYREPACK INC. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 49349-566_b879f7c5-c47e-4644-a5a8-ec8e357fbf0f 49349-566 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20130404 NDA NDA018569 REMEDYREPACK INC. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 49349-569_1d067a4d-6874-4852-90c5-f6eeb78b11ef 49349-569 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20130911 NDA NDA021283 REMEDYREPACK INC. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49349-570_8f7a1eb0-37d2-4dce-883a-229da8d38780 49349-570 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20131008 ANDA ANDA084324 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-570_ff5a45c1-beee-4af5-9630-bf787dc3c0c2 49349-570 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20131008 ANDA ANDA084324 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-572_0450366c-0b6a-4627-90db-4c8b9f63a42f 49349-572 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130320 ANDA ANDA074984 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-572_c9b2b8a4-6e13-4141-bbd2-db259f3cfee6 49349-572 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20131211 ANDA ANDA074984 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-573_889953f4-8696-4c46-b7ae-d9be99d3dbce 49349-573 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130927 ANDA ANDA084277 REMEDYREPACK INC. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49349-574_03c33217-5cdd-4cf0-adfc-471c8ddf08a0 49349-574 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20130305 ANDA ANDA075786 REMEDYREPACK INC. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 49349-575_298ddbd4-1347-41bf-b231-cf20f5c88987 49349-575 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20111011 ANDA ANDA075483 REMEDYREPACK INC. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 49349-577_71816f78-a99d-459d-92e6-4104adbfa3b9 49349-577 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20130305 ANDA ANDA075786 REMEDYREPACK INC. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 49349-578_a1f9b623-1b9a-4322-9072-76832d09f3db 49349-578 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20101207 ANDA ANDA090118 REMEDYREPACK INC. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49349-579_1d3f7369-0094-4c37-a172-8c2f08bbff98 49349-579 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20141121 ANDA ANDA076286 REMEDYREPACK INC. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 49349-582_a1c474ff-4706-4ec4-b5d1-de1a2ed3305e 49349-582 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 20111012 ANDA ANDA072100 REMEDYREPACK INC. DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 49349-583_cd1e8014-427a-4af4-bc42-38cd1f7f21b9 49349-583 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20111013 ANDA ANDA070178 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-584_2cdd6bdb-fb4c-471c-b13d-3e14d79585d4 49349-584 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20111012 ANDA ANDA076920 REMEDYREPACK INC. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-585_e0ebf8b5-d0ff-4c0c-a94a-2a00eaa231b9 49349-585 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20110518 ANDA ANDA040742 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 49349-586_967e7d4c-0c84-4fcf-bf2b-d59047fe8954 49349-586 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20111013 ANDA ANDA078010 REMEDYREPACK INC. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 49349-586_cc9fadd3-2598-4b90-9438-e60d5e778836 49349-586 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20130405 ANDA ANDA078010 REMEDYREPACK INC. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 49349-588_2f235319-2804-4bf6-a68e-c7fce05b7885 49349-588 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET ORAL 20111017 ANDA ANDA077127 REMEDYREPACK INC. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49349-590_36523783-439d-45d7-a9ce-9723e2db500e 49349-590 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20111021 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-591_b32bdab0-c42d-48db-b0a2-95d022cce916 49349-591 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20111021 ANDA ANDA070278 REMEDYREPACK INC. HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] 49349-593_42c15aeb-bee9-4cfe-beb6-0ffbe63a01c5 49349-593 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20111024 ANDA ANDA071851 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-594_8b701c63-0938-4740-be41-44f646ea1cca 49349-594 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20111024 ANDA ANDA075300 REMEDYREPACK INC. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-595_41de2b56-b2bd-49ef-8e1e-34ca0893bce8 49349-595 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111025 ANDA ANDA070674 REMEDYREPACK INC. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-597_115b5587-e1c4-4a91-a977-e688a26eb694 49349-597 HUMAN PRESCRIPTION DRUG Thiothixene Thiothixene CAPSULE ORAL 20111025 ANDA ANDA071610 REMEDYREPACK INC. THIOTHIXENE 1 mg/1 Typical Antipsychotic [EPC] 49349-598_3f2302d5-7965-404c-a4df-45eeabc9a8b5 49349-598 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET ORAL 20111025 ANDA ANDA089585 REMEDYREPACK INC. FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 49349-599_5763dd98-a3b9-41ab-88e7-badbb7ed27b0 49349-599 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130305 ANDA ANDA076649 REMEDYREPACK INC. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 49349-600_f67f47d3-9295-4d36-85c2-fce90db7326a 49349-600 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20111102 ANDA ANDA073449 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-603_9b4fc370-3f93-4562-8704-8139ae37f704 49349-603 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20111102 ANDA ANDA078459 REMEDYREPACK INC. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-604_9ed1d7fe-c0b0-433e-bc8b-e10573b4d599 49349-604 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20141112 ANDA ANDA078432 REMEDYREPACK INC. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-604_e1fa2f83-6da6-476e-9cfe-b9d934797b65 49349-604 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20111103 ANDA ANDA078432 REMEDYREPACK INC. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-605_04048525-3e8a-4b85-98ff-f493fbe71952 49349-605 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111103 ANDA ANDA040301 REMEDYREPACK INC. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-606_bccd974b-82bf-426b-a8af-171f468e6c5b 49349-606 HUMAN PRESCRIPTION DRUG Mercaptopurine Mercaptopurine TABLET ORAL 20111103 ANDA ANDA040528 REMEDYREPACK INC. MERCAPTOPURINE 50 mg/1 49349-607_0b91b0c0-38f1-4e49-99c5-15e3b4883c79 49349-607 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20130703 ANDA ANDA084283 REMEDYREPACK INC. PREDNISONE 50 mg/1 49349-607_27d3ff78-e3af-41cf-ae0a-ec94b34eef3e 49349-607 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20141124 ANDA ANDA084283 REMEDYREPACK INC. PREDNISONE 50 mg/1 49349-607_841a8add-6c92-4dcf-80c5-3589af9c14cd 49349-607 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20120831 ANDA ANDA084283 REMEDYREPACK INC. PREDNISONE 50 mg/1 49349-607_ed6c1a25-bef1-4bd8-9308-3197d144c6e6 49349-607 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20111103 ANDA ANDA084283 REMEDYREPACK INC. PREDNISONE 50 mg/1 49349-609_314254bc-57be-4253-b11d-975720658cee 49349-609 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20101216 ANDA ANDA085968 REMEDYREPACK INC. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 49349-610_fe8a4012-673b-4313-bf64-7bed2083c74f 49349-610 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride Paroxetine Hydrochloride TABLET ORAL 20111103 ANDA ANDA078406 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-612_4bfdbcb4-ab48-4a25-963d-b7955b2eede9 49349-612 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20110315 ANDA ANDA075593 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-612_9ed37a42-ec21-4de3-9bcc-f1d3817482e1 49349-612 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20110524 ANDA ANDA075593 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-613_04037710-f163-4c9d-8482-6e4dcf7d6946 49349-613 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20130725 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-613_37598a8e-8069-4e35-9d20-01377af392ed 49349-613 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110311 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-613_47c8089d-2d6f-465a-9aa9-2a07b9fc3e0b 49349-613 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20111104 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-613_6da8c0fb-a48f-42e6-82b5-6afdc53685ed 49349-613 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110510 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-613_edc32d15-a53a-4e68-b11b-3472b93f7c38 49349-613 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20131211 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-614_2bf7bc0a-6a48-4a4c-beab-49283802560d 49349-614 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20111107 ANDA ANDA077802 REMEDYREPACK INC. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-615_ecc66746-cf70-461a-921f-33d5751277fe 49349-615 HUMAN PRESCRIPTION DRUG Levetiractam Levetiracetam TABLET ORAL 20111107 ANDA ANDA078858 REMEDYREPACK INC. LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-617_8f4c015d-800d-4265-9dcd-e8288ca06a6f 49349-617 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET ORAL 20111206 ANDA ANDA085967 REMEDYREPACK INC. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 49349-618_641c5d68-e838-49b7-b3a1-d7e04ba9acc4 49349-618 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111206 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-619_a64b16b6-189d-48a4-8509-438a289e252f 49349-619 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20130501 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 49349-620_330cd503-4805-4419-98f8-05f13c704ccb 49349-620 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20111206 ANDA ANDA074578 REMEDYREPACK INC. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-622_07f2856f-cacf-4d4c-aafe-84a994753905 49349-622 HUMAN PRESCRIPTION DRUG Perphenazine and Amitriptyline Hydrochloride Perphenazine and Amitriptyline Hydrochloride TABLET ORAL 20111207 ANDA ANDA071443 REMEDYREPACK INC. AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE 50; 4 mg/1; mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] 49349-623_34d4e738-bf98-495e-8c79-58089ba9ce56 49349-623 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111207 ANDA ANDA073568 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-624_6670ca25-091e-4cda-9b6f-708ceb18e28b 49349-624 HUMAN PRESCRIPTION DRUG Invirase saquinavir mesylate CAPSULE ORAL 20130501 NDA NDA020628 REMEDYREPACK INC. SAQUINAVIR MESYLATE 200 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 49349-625_2314e279-e015-417b-9384-ac011d926a91 49349-625 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20111207 ANDA ANDA040416 REMEDYREPACK INC. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-626_99565aa0-12d3-47e7-b0b5-a54e00dcdded 49349-626 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20111207 NDA NDA008678 REMEDYREPACK INC. ISONIAZID 300 mg/1 Antimycobacterial [EPC] 49349-627_af0c2c74-c27c-4280-8371-47cf7a7bdd26 49349-627 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20110510 ANDA ANDA084769 REMEDYREPACK INC. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49349-628_cc8ca34e-e49d-423a-a7e7-a810a7be14d9 49349-628 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20111207 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-630_568f861a-7bd4-4a8b-a82a-756665144da2 49349-630 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20111207 ANDA ANDA078858 REMEDYREPACK INC. LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-631_1677a28b-67d9-4f04-a358-b48402466460 49349-631 HUMAN PRESCRIPTION DRUG Thiothixene Thiothixene CAPSULE ORAL 20111207 ANDA ANDA071093 REMEDYREPACK INC. THIOTHIXENE 2 mg/1 Typical Antipsychotic [EPC] 49349-632_ec1159a4-0724-46e7-b55c-95d2984f29aa 49349-632 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20111207 ANDA ANDA090467 REMEDYREPACK INC. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49349-634_7fab8056-6339-4224-9320-d136b05004a1 49349-634 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE TABLET ORAL 20130724 ANDA ANDA075593 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-634_9ada7975-ff9c-497a-bb91-b5da9a4e71c5 49349-634 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET ORAL 20130724 ANDA ANDA075593 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-634_a39bcfed-284b-47d8-a97c-85a978900fcd 49349-634 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride CIPROFLOXACIN HYDROCHLORIDE TABLET ORAL 20130730 ANDA ANDA075593 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-634_da634c3a-6dc6-48e7-b428-4d5187273a34 49349-634 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET ORAL 20111207 ANDA ANDA075593 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-634_fd723994-293b-43c6-bd60-342b8707e34f 49349-634 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET ORAL 20130724 ANDA ANDA075593 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-635_632228db-8f3f-4cf4-a139-8fe8b35817ff 49349-635 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, EXTENDED RELEASE ORAL 20111208 NDA NDA020329 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49349-636_e6ae2c04-d249-4c0e-9dc2-8b498cf8ae41 49349-636 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20110408 ANDA ANDA040123 REMEDYREPACK INC. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49349-638_dea1370f-14f6-4a25-aecd-e19dcc8787cd 49349-638 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride Trifluoperazine Hydrochloride TABLET ORAL 20131004 ANDA ANDA085785 REMEDYREPACK INC. TRIFLUOPERAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 49349-638_f9f06be8-4b08-4e71-bc8c-f38c5538bd4f 49349-638 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride Trifluoperazine Hydrochloride TABLET ORAL 20111208 ANDA ANDA085785 REMEDYREPACK INC. TRIFLUOPERAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 49349-639_5a5df127-76e2-4eaa-865c-86939e899c80 49349-639 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20111208 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-642_08db4afe-78f4-44a1-8537-0ed0ac9a4259 49349-642 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20130520 ANDA ANDA078155 REMEDYREPACK INC. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-642_ac7e1545-239a-4b03-87d6-767b2639ba8b 49349-642 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20130501 ANDA ANDA078155 REMEDYREPACK INC. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-644_0bff4828-a821-4127-a0cc-f3dd82eec12c 49349-644 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20111209 ANDA ANDA086242 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 49349-645_a8989de9-aa5a-49cb-aad0-346932efe166 49349-645 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20111212 ANDA ANDA073555 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 49349-646_3c1027ef-719c-491a-ae3c-0a06eaa11089 49349-646 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET ORAL 20130722 ANDA ANDA078155 REMEDYREPACK INC. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-646_dbeae33f-6f6c-449b-9e6d-dcef6d8326d2 49349-646 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20111208 ANDA ANDA078155 REMEDYREPACK INC. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-647_89b73110-1abe-478b-9909-a39d3aa58eec 49349-647 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET ORAL 20131204 ANDA ANDA040804 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 49349-647_de794672-5a22-4011-b3ac-4f3d3c5ef21c 49349-647 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET ORAL 20110311 ANDA ANDA040804 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 49349-648_a76e14eb-a8ad-415b-8df3-e74719c94144 49349-648 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET ORAL 20110523 ANDA ANDA040804 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 49349-649_26da45e6-42a2-48d0-a654-0f42ec1d6dfe 49349-649 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20130501 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 49349-650_2c6dfc8d-7f69-41f4-8d30-d2a1863b6e8c 49349-650 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20110909 ANDA ANDA077662 REMEDYREPACK INC. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-651_2fc8f5b1-bcef-4dfc-912c-e92e8f132389 49349-651 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20110909 ANDA ANDA078155 REMEDYREPACK INC. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-651_47fd15ed-2686-4355-81b5-8ccce2ae7f86 49349-651 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET ORAL 20130730 ANDA ANDA078155 REMEDYREPACK INC. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-652_767389ff-ddca-4989-9414-3f4cb74801ee 49349-652 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET ORAL 20110311 ANDA ANDA075310 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49349-653_0107264f-797d-4dfc-b6e4-3b9b182d2ac8 49349-653 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20110510 ANDA ANDA075491 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49349-654_c684910d-7b4c-4d75-ad0c-0755d6dc9913 49349-654 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 20110518 ANDA ANDA071826 REMEDYREPACK INC. MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 49349-655_637b12a6-9e7d-4721-9b30-1f9ca29e57dc 49349-655 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET ORAL 20130911 NDA NDA021519 REMEDYREPACK INC. FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-656_a3b3c00e-089f-4a53-9f6e-95e86a37f332 49349-656 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20110510 ANDA ANDA040738 REMEDYREPACK INC. BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 49349-658_09a8e49b-e65a-4500-a236-9ff285782d0d 49349-658 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20110523 ANDA ANDA040145 REMEDYREPACK INC. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-659_ff4e5db1-5b44-49ef-9575-acdbac8861df 49349-659 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20110310 ANDA ANDA040254 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 49349-662_5a72a29c-da69-4f0f-be11-60c18e9b78f9 49349-662 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET ORAL 20110523 ANDA ANDA076794 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-663_ca09c133-dba6-4022-89a2-67a9d237c509 49349-663 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20110310 ANDA ANDA086221 REMEDYREPACK INC. ISOSORBIDE DINITRATE 5 mg/1 49349-664_a56e1487-c186-475a-a760-9119e20836ae 49349-664 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20110516 ANDA ANDA072265 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 49349-665_c960638c-375c-4369-ab42-a17af2f3ff68 49349-665 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazle and Trimethoprim TABLET ORAL 20110517 ANDA ANDA076899 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 49349-665_fa41745d-1ae9-4626-9b6d-7be2e447e606 49349-665 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20110517 ANDA ANDA076899 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 49349-666_85b1f809-6fd6-44dd-a401-79027509f810 49349-666 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20110516 ANDA ANDA060704 REMEDYREPACK INC. TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 49349-667_57792e3a-48bf-47a4-aa87-3bde61bdd3e2 49349-667 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET ORAL 20110516 ANDA ANDA040808 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 49349-668_d102ed90-b43c-4cb5-8b4d-a1b00b0fea20 49349-668 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20110516 ANDA ANDA074556 REMEDYREPACK INC. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-669_e60df0f5-b8ec-488d-9354-1b0f6b2bd161 49349-669 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20110524 ANDA ANDA070176 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-671_dd96b8ed-ebb2-4034-965d-b4bc38bb0d69 49349-671 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20110310 ANDA ANDA040655 REMEDYREPACK INC. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49349-673_a6b59744-fb92-4155-ae64-a05baed3cab7 49349-673 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20110310 ANDA ANDA040715 REMEDYREPACK INC. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 49349-674_3a0eb1f9-8fde-47c9-bd3d-5229f0cf35c2 49349-674 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20110512 ANDA ANDA075022 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 15 mg/1 49349-675_1306ac2e-163f-4ab0-99c3-035ea3fc8c35 49349-675 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20130409 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-675_7d47a06a-8389-4699-9fe4-b5f0cc2466c5 49349-675 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110516 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-675_98cebaef-38b5-4dd2-96c0-a673f2fff1ec 49349-675 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20130319 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-676_97cc7997-38d9-4a32-ab03-e3f87546dd05 49349-676 HUMAN PRESCRIPTION DRUG Epivir Lamivudine TABLET, FILM COATED ORAL 20110713 NDA NDA020564 REMEDYREPACK INC. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-676_bbff8146-19b2-4774-8b7f-7b57adba9a6c 49349-676 HUMAN PRESCRIPTION DRUG Epivir Lamivudine TABLET ORAL 20110913 NDA NDA020564 REMEDYREPACK INC. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-677_1a09c749-6cee-47e7-b53c-0f11a56fd46b 49349-677 HUMAN PRESCRIPTION DRUG Carbamazepine CARBAMAZEPINE TABLET ORAL 20120904 ANDA ANDA070541 REMEDYREPACK INC. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 49349-677_d1be6472-feef-42fe-961c-dbc9ae93a508 49349-677 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 20110516 ANDA ANDA070541 REMEDYREPACK INC. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 49349-678_71e66a7c-fd15-43dd-8efd-b3fb0c5c9d63 49349-678 HUMAN PRESCRIPTION DRUG Asacol Asacol TABLET, DELAYED RELEASE ORAL 20110309 NDA NDA019651 REMEDYREPACK INC. MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 49349-679_6c7b811f-123f-4b25-a088-dc523d0a6049 49349-679 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20110512 ANDA ANDA065155 REMEDYREPACK INC. CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 49349-680_3b593983-8f7d-4ac1-8203-2c45daa78f15 49349-680 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20110512 ANDA ANDA040353 REMEDYREPACK INC. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 49349-681_00f98cf5-35a1-400c-aaff-32e24f422ca7 49349-681 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20110513 ANDA ANDA079237 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-682_806f29ad-8731-41f1-a156-a664b39cbc8c 49349-682 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20110513 ANDA ANDA074132 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 49349-683_78c5f329-723b-48d0-b354-d656a9cc1941 49349-683 HUMAN PRESCRIPTION DRUG COMBIVIR lamivudine and zidovudine TABLET, FILM COATED ORAL 20130423 NDA NDA020857 REMEDYREPACK INC. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-683_bc7dfa93-b00d-40d4-9915-b52a5aad6211 49349-683 HUMAN PRESCRIPTION DRUG COMBIVIR lamivudine and zidovudine TABLET, FILM COATED ORAL 20130423 NDA NDA020857 REMEDYREPACK INC. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-683_ee4a5680-e187-476c-8ec6-bdcdbee7841b 49349-683 HUMAN PRESCRIPTION DRUG COMBIVIR lamivudine and zidovudine TABLET, FILM COATED ORAL 20130423 NDA NDA020857 REMEDYREPACK INC. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-684_5b7d1d7d-9b48-4538-b689-1f56b55c99f1 49349-684 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110513 ANDA ANDA078432 REMEDYREPACK INC. NAPROXEN SODIUM 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-685_4b201537-e7c3-48a8-8090-025395aa2481 49349-685 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET ORAL 20110412 ANDA ANDA065193 REMEDYREPACK INC. AZITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 49349-686_eb728d64-f3f2-4e32-a1e0-8328bc39b468 49349-686 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20110309 ANDA ANDA075828 REMEDYREPACK INC. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-687_a9446165-bec1-42c4-acc2-f679bc9dfe76 49349-687 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20110316 ANDA ANDA075451 REMEDYREPACK INC. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-688_f664d1b0-f670-4c81-a879-b918fb1eed5e 49349-688 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20110520 ANDA ANDA077794 REMEDYREPACK INC. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-689_0ac6baf1-c76b-4e60-ba6b-82aca54426e0 49349-689 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20110316 ANDA ANDA040736 REMEDYREPACK INC. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49349-690_d2bef127-7af3-4d25-83f4-5a333a6c08fb 49349-690 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20110517 ANDA ANDA075140 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-691_371ec998-d778-42c7-bd46-89a9d3d903f2 49349-691 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20110517 ANDA ANDA076691 REMEDYREPACK INC. LITHIUM CARBONATE 450 mg/1 49349-692_4d437668-d532-4d99-b14a-afd35523909a 49349-692 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20110520 ANDA ANDA077794 REMEDYREPACK INC. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-694_ebc0207f-2043-49f3-8503-5fa41451b1d9 49349-694 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, CHEWABLE ORAL 20110713 ANDA ANDA075712 REMEDYREPACK INC. CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 49349-695_90690478-6022-4da3-8a22-6c4e99044cbb 49349-695 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20110323 ANDA ANDA074253 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 15 mg/1 49349-696_89e4605c-86fa-408b-a360-da7113b329f5 49349-696 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET ORAL 20110330 ANDA ANDA088618 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 49349-697_f9fbb31f-543c-4b0f-9ee3-553c1f52c4d4 49349-697 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20110516 ANDA ANDA077031 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-698_ea020e34-0852-44cc-9341-a05fbbc60644 49349-698 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110516 ANDA ANDA078807 REMEDYREPACK INC. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 49349-700_03c5bd21-5240-4c0d-a5ad-9f8fea434d7b 49349-700 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20110406 ANDA ANDA040715 REMEDYREPACK INC. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 49349-701_d9d63875-a435-479f-ae39-e83ad7462d93 49349-701 HUMAN PRESCRIPTION DRUG Epzicom Abacavir Sulfate and Lamivudine TABLET, FILM COATED ORAL 20110912 NDA NDA021652 REMEDYREPACK INC. ABACAVIR SULFATE; LAMIVUDINE 600; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-702_d3362e48-b1d4-4d28-9e05-e562a604ad49 49349-702 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20110912 ANDA ANDA076194 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-704_647596a6-7eb4-4160-aa4c-71eca292ceb6 49349-704 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET ORAL 20110912 ANDA ANDA075310 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49349-705_4b6a1a0f-6caa-49c1-9e59-0e013490b458 49349-705 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110913 ANDA ANDA079162 REMEDYREPACK INC. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-706_349e50e4-d675-455a-a7b6-dc5635061987 49349-706 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130521 NDA NDA019123 REMEDYREPACK INC. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 49349-706_94f491b9-659a-414a-8dc5-2e9aaa7b908d 49349-706 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120911 NDA NDA019123 REMEDYREPACK INC. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 49349-707_950a1e31-8645-44fa-b4a9-ca1904e7a0be 49349-707 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110908 ANDA ANDA075979 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-708_9dddd177-2934-4523-8a54-3d1d0f04574b 49349-708 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110908 ANDA ANDA074984 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-709_2814d02e-ea7d-406f-afb6-f9e34f281bf3 49349-709 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20110908 ANDA ANDA077918 REMEDYREPACK INC. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-709_c46c814a-545b-4b7e-a732-23fae5fb3800 49349-709 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20130520 ANDA ANDA077918 REMEDYREPACK INC. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-710_de1ec16d-bfae-462a-9b33-1f9f9f32ff73 49349-710 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20110908 ANDA ANDA076420 REMEDYREPACK INC. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-711_58bcfd19-3510-4ba4-86c8-26b44f43d6a9 49349-711 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20130514 NDA NDA021411 REMEDYREPACK INC. ATOMOXETINE HYDROCHLORIDE 80 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 49349-712_0d786616-0752-4da5-a6b8-a59668a6657a 49349-712 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110830 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-712_3db7b319-1594-46f8-87e9-6a841a9d0e1a 49349-712 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20130730 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-712_a17be773-48b6-4bad-8011-461ce3ee9374 49349-712 HUMAN PRESCRIPTION DRUG Naproxen NAPROXEN TABLET ORAL 20120904 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-713_afd69ee3-4580-4ba8-8000-ab7c747daf3d 49349-713 HUMAN PRESCRIPTION DRUG Epivir Lamivudine TABLET ORAL 20110830 NDA NDA020564 REMEDYREPACK INC. LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-714_09d9c960-e01f-4571-bfba-f76278479d9b 49349-714 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET ORAL 20110901 ANDA ANDA077851 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 49349-715_455a4c6c-db51-4e15-9a84-a243e9ca1be9 49349-715 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE ORAL 20110906 ANDA ANDA071813 REMEDYREPACK INC. OXAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49349-716_03806e52-caae-4ba5-8da5-88f1db9b4d07 49349-716 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20110830 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-717_5dc143ed-85f1-4cd5-9820-9b1a0069396d 49349-717 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20110830 ANDA ANDA040256 REMEDYREPACK INC. PREDNISONE 10 mg/1 49349-718_4d1cfae2-3a83-4fa2-803c-aac6085ca079 49349-718 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20110830 ANDA ANDA040301 REMEDYREPACK INC. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-719_2895a7a1-c6b6-416f-8fbf-ffcb4d30aebf 49349-719 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20110511 ANDA ANDA074223 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49349-721_3e854b7b-ffc7-45dd-bc9f-16dc58fd7fb7 49349-721 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20131230 ANDA ANDA079237 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-721_5723ec7b-8647-4900-9681-1b7652cb7608 49349-721 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20110830 ANDA ANDA040807 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-721_e5a2d5b6-6c99-4ac9-b345-507e4e1cfd77 49349-721 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20130604 ANDA ANDA079237 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-722_16ae553b-1523-4483-922e-a641e30ebbe9 49349-722 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20110830 ANDA ANDA077918 REMEDYREPACK INC. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-722_ed3bcf58-bd77-4343-9e78-7e243a6e0791 49349-722 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20130510 ANDA ANDA077918 REMEDYREPACK INC. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-723_c53af9c2-8ee0-41ba-b2e1-5d01c2d63fab 49349-723 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20130228 ANDA ANDA040796 REMEDYREPACK INC. FOLIC ACID 1 mg/1 49349-724_99d6394b-3752-4de7-a5e5-8f2cf0f708a2 49349-724 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 20130228 ANDA ANDA074532 REMEDYREPACK INC. CAPTOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-725_5b3ca522-61dd-48aa-b1b3-7a6ff0c0e3c9 49349-725 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130228 ANDA ANDA040362 REMEDYREPACK INC. PREDNISONE 10 mg/1 49349-726_74a15662-6a7a-4b8e-a17f-00588c0cf292 49349-726 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111222 ANDA ANDA077715 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49349-726_d506e5cc-83c3-4f44-aeb7-b7dd9aa85818 49349-726 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET ORAL 20110825 ANDA ANDA077715 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49349-727_c8b9a698-cc61-4603-a250-67343e39a783 49349-727 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110823 ANDA ANDA078947 REMEDYREPACK INC. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-727_e026f787-f67c-4001-a03a-f990d67a7ad9 49349-727 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110829 ANDA ANDA078947 REMEDYREPACK INC. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-728_7b31b0b8-d1d2-4533-a387-bdd73f444fca 49349-728 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20110823 ANDA ANDA075022 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 15 mg/1 49349-729_ca5763a5-a705-496a-b6f7-8dc3f511bffe 49349-729 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20110823 ANDA ANDA076042 REMEDYREPACK INC. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 49349-730_279e9987-dd4d-4376-a35b-e124aeb2165c 49349-730 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20110823 ANDA ANDA076257 REMEDYREPACK INC. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49349-731_56cb86c3-0b06-4bed-864a-682b9716adee 49349-731 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20131230 ANDA ANDA077031 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-731_840339a5-8297-45ff-b39d-7dee558bf2c3 49349-731 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20130304 ANDA ANDA077031 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-732_508e3ac7-fe21-4c5a-b146-2bd82bd8ffc5 49349-732 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110824 ANDA ANDA074587 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-733_08ddbb9f-3d11-4d2b-9a45-f9794b8308b7 49349-733 HUMAN PRESCRIPTION DRUG Ery-Tab Erythromycin TABLET, DELAYED RELEASE ORAL 20110824 ANDA ANDA062298 REMEDYREPACK INC. ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 49349-734_d2ba1110-6f77-4f54-84dd-52f721d2351d 49349-734 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20110824 ANDA ANDA077927 REMEDYREPACK INC. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-737_258048d8-0171-4964-b839-9a71789325d8 49349-737 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE TABLET ORAL 20120904 ANDA ANDA074754 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-737_5c1ea979-612e-4b47-9c39-ab0644db452e 49349-737 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET ORAL 20111228 ANDA ANDA074754 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-737_d07a3811-9b72-43d5-8ac8-ff0338f89c49 49349-737 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET ORAL 20131211 ANDA ANDA074754 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-737_e288732a-982d-4b12-92eb-1eee66946ea3 49349-737 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET ORAL 20131211 ANDA ANDA074754 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-738_3b9a34f4-0fae-4031-8701-f97d9dd3ef13 49349-738 HUMAN PRESCRIPTION DRUG ADVAIRDISKUS DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20130610 NDA NDA021077 REMEDYREPACK INC. FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 500; 50 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 49349-738_da3523a6-0d46-42f7-9345-e54e50d04d0f 49349-738 HUMAN PRESCRIPTION DRUG ADVAIRDISKUS DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20130610 NDA NDA021077 REMEDYREPACK INC. FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 500; 50 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 49349-739_b322fdea-bffb-49d7-a3cb-77b4507834d7 49349-739 HUMAN PRESCRIPTION DRUG Bacteriostatic Water WATER INJECTION, SOLUTION INTRAMUSCULAR 20131031 NDA NDA018802 REMEDYREPACK INC. WATER 1 mL/mL 49349-739_cca8fbbe-6afd-4395-bad6-319234cf5347 49349-739 HUMAN PRESCRIPTION DRUG Bacteriostatic Water WATER INJECTION, SOLUTION INTRAMUSCULAR 20131031 NDA NDA018802 REMEDYREPACK INC. WATER 1 mL/mL 49349-739_f93eb117-0c1d-4362-815f-e1dbf13058f0 49349-739 HUMAN PRESCRIPTION DRUG Bacteriostatic Water WATER INJECTION, SOLUTION INTRAMUSCULAR 20130610 NDA NDA018802 REMEDYREPACK INC. WATER 1 mL/mL 49349-740_fb2457cc-cf57-4a7f-91dd-f52eb5a24335 49349-740 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20130612 ANDA ANDA088299 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 49349-742_8e835f05-31c2-43b1-8da3-fd210e6a13a4 49349-742 HUMAN PRESCRIPTION DRUG Denavir penciclovir CREAM TOPICAL 20130611 NDA NDA020629 REMEDYREPACK INC. PENCICLOVIR 10 mg/g DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-742_9ef4733b-aabb-4d71-849f-b63e1f3752c8 49349-742 HUMAN PRESCRIPTION DRUG Denavir penciclovir CREAM TOPICAL 20131118 NDA NDA020629 REMEDYREPACK INC. PENCICLOVIR 10 mg/g DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-743_fa3db135-ace4-4101-8f8e-960adff7fa01 49349-743 HUMAN PRESCRIPTION DRUG Zithromax azithromycin TABLET, FILM COATED ORAL 20130404 NDA NDA050711 REMEDYREPACK INC. AZITHROMYCIN, UNSPECIFIED FORM 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 49349-745_3e196251-b77c-4891-8a82-236ce0eed7dd 49349-745 HUMAN PRESCRIPTION DRUG PROAIRHFA HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20130613 NDA NDA021457 REMEDYREPACK INC. ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 49349-746_8c7db9f6-ba52-4f0a-827a-a9ab30908a71 49349-746 HUMAN PRESCRIPTION DRUG FLOVENTHFA HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20130611 NDA NDA021433 REMEDYREPACK INC. FLUTICASONE PROPIONATE 44 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49349-747_0b120d45-d07c-471c-92b4-a101a58287c7 49349-747 HUMAN PRESCRIPTION DRUG EpiPen Epinephrine INJECTION INTRAMUSCULAR 20130611 NDA NDA019430 REMEDYREPACK INC. EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 49349-747_e52a200d-6f59-42f4-ac00-ebb0a190921a 49349-747 HUMAN PRESCRIPTION DRUG EpiPen Epinephrine INJECTION INTRAMUSCULAR 20130927 NDA NDA019430 REMEDYREPACK INC. EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 49349-749_66747b27-9734-47a4-ae0b-b1cd6dbfb750 49349-749 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SPRAY, METERED NASAL 20130612 ANDA ANDA076103 REMEDYREPACK INC. IPRATROPIUM BROMIDE ANHYDROUS 42 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 49349-750_ae8c0cff-9c64-4139-8eab-33b4eae07839 49349-750 HUMAN PRESCRIPTION DRUG Methylprednisolone METHYLPREDNISOLONE TABLET ORAL 20120905 ANDA ANDA040194 REMEDYREPACK INC. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49349-751_7f90cee9-7e2e-4f3c-9549-c9bdf41fdaf0 49349-751 HUMAN PRESCRIPTION DRUG Zyvox linezolid TABLET, FILM COATED ORAL 20130403 NDA NDA021130 REMEDYREPACK INC. LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] 49349-751_dfff1a04-96b7-4abd-83d2-80043d8805c4 49349-751 HUMAN PRESCRIPTION DRUG Zyvox linezolid TABLET, FILM COATED ORAL 20130403 NDA NDA021130 REMEDYREPACK INC. LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] 49349-752_edc65393-6e02-40af-800f-f7b544a2bcaa 49349-752 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20130403 ANDA ANDA040755 REMEDYREPACK INC. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49349-753_116c7171-bfb1-48fc-b18e-eb342295508e 49349-753 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR 20140514 ANDA ANDA077942 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-753_8d0d5971-5b73-4cd8-aa49-0f67eb635be8 49349-753 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR 20130612 ANDA ANDA077942 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-755_c1b02318-879e-4b90-a648-c554269ab4e5 49349-755 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRAMUSCULAR 20130611 NDA NDA011757 REMEDYREPACK INC. METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49349-756_3c4e71a7-f190-4b12-ada1-9eff4c803b26 49349-756 HUMAN PRESCRIPTION DRUG FLONASE Fluticasone Propionate SPRAY, METERED NASAL 20130611 NDA NDA020121 REMEDYREPACK INC. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49349-757_982e3190-cb1d-4fb8-97ed-09d2f66599d4 49349-757 HUMAN PRESCRIPTION DRUG CELESTONE SOLUSPAN Betamethasone Acetate and Betamethasone Sodium Phosphate INJECTION, SUSPENSION INTRAMUSCULAR 20130610 NDA NDA014602 REMEDYREPACK INC. BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE 3; 3 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49349-758_32f739c6-a171-4fb6-8857-36e71546990e 49349-758 HUMAN PRESCRIPTION DRUG Adenoscan adenosine SOLUTION INTRAVENOUS 20130627 NDA NDA020059 REMEDYREPACK INC. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 49349-758_8d01b35b-3d64-4ade-87dc-b1ee0a0f2899 49349-758 HUMAN PRESCRIPTION DRUG Adenoscan adenosine SOLUTION INTRAVENOUS 20131031 NDA NDA020059 REMEDYREPACK INC. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 49349-759_97de3690-272d-4f25-9eee-a1cb80b35f45 49349-759 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL 20131129 NDA NDA016964 REMEDYREPACK INC. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 49349-759_d6ae2776-bc4c-40cc-823a-84cbaa2ef95f 49349-759 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL 20130612 NDA NDA016964 REMEDYREPACK INC. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 49349-763_0ac5d4b6-ef00-4893-aafe-23dc67c08d5f 49349-763 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20130612 ANDA ANDA040302 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 49349-764_834d8d8a-086f-4799-8fcc-fb2f952d9020 49349-764 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION INTRAVENOUS 20130610 NDA NDA018800 REMEDYREPACK INC. SODIUM CHLORIDE 9 mg/mL 49349-765_3c8cc726-21c9-4728-b8e1-cd0ddac94d8d 49349-765 HUMAN PRESCRIPTION DRUG Valium diazepam TABLET ORAL 20121128 NDA NDA013263 REMEDYREPACK INC. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49349-766_66e79761-181c-4a26-b47f-fbf3bcc2dde9 49349-766 HUMAN PRESCRIPTION DRUG Parafon Forte DSC chlorzoxazone TABLET ORAL 20121128 NDA NDA011529 REMEDYREPACK INC. CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49349-768_c0515b41-7708-4b22-8ecf-422a30340750 49349-768 HUMAN PRESCRIPTION DRUG Xopenex levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20130613 NDA NDA020837 REMEDYREPACK INC. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 49349-772_f74666fd-8573-46e2-935a-b0bcb40d1215 49349-772 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20110822 ANDA ANDA077794 REMEDYREPACK INC. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-773_d882e329-2314-49e2-870e-21ba096aa0f6 49349-773 HUMAN PRESCRIPTION DRUG Ery-Tab Erythromycin TABLET ORAL 20110819 ANDA ANDA062298 REMEDYREPACK INC. ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 49349-774_c8cacd3e-4124-4ceb-9e0e-97d7d30f9cb5 49349-774 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET ORAL 20110908 ANDA ANDA075491 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49349-776_b2643f10-967c-42c4-8c02-570f2782ded8 49349-776 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20110908 ANDA ANDA018851 REMEDYREPACK INC. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-777_21388338-317f-424f-8d88-b45c2ea96763 49349-777 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20131211 ANDA ANDA080212 REMEDYREPACK INC. ISONIAZID 100 mg/1 Antimycobacterial [EPC] 49349-777_ed7eec46-b15c-415a-b463-5455d9f1db7c 49349-777 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20110906 ANDA ANDA080212 REMEDYREPACK INC. ISONIAZID 100 mg/1 Antimycobacterial [EPC] 49349-778_7071e4a0-f6d4-4085-a18c-8e641d87d474 49349-778 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110907 ANDA ANDA079162 REMEDYREPACK INC. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-779_61b747f4-59ee-4511-ab25-6c516ec8435a 49349-779 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20110921 ANDA ANDA078154 REMEDYREPACK INC. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-780_412056fc-9be1-43bb-9dfe-dfed6725d268 49349-780 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110927 ANDA ANDA040412 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-781_7d06203d-00ac-4fc6-9de1-1504a793c15b 49349-781 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20110920 ANDA ANDA040644 REMEDYREPACK INC. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 49349-782_636103d9-3a97-4127-bfca-e3deb5fea9c4 49349-782 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20140521 ANDA ANDA088327 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 49349-782_dc214984-c988-4e60-bf82-302436fbe797 49349-782 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20130927 ANDA ANDA088327 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 49349-783_82c24800-0280-4d72-aefa-9e4251853434 49349-783 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20141028 ANDA ANDA085162 REMEDYREPACK INC. PREDNISONE 10 mg/1 49349-783_9e732426-28d1-4ffb-be72-2705bf1a5911 49349-783 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20110926 ANDA ANDA085162 REMEDYREPACK INC. PREDNISONE 10 mg/1 49349-785_413d6c6c-d740-474d-bec7-2cdebebfa400 49349-785 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20110927 ANDA ANDA078069 REMEDYREPACK INC. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-786_b10b4825-9771-4233-b86b-d6e93d262868 49349-786 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20110928 ANDA ANDA080937 REMEDYREPACK INC. ISONIAZID 300 mg/1 Antimycobacterial [EPC] 49349-787_212ede3e-8d4b-43c8-ac3c-dd8ebc7af7de 49349-787 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20111010 ANDA ANDA077156 REMEDYREPACK INC. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 49349-788_f2b84d6a-d43a-48ff-b23c-bdb5efec3828 49349-788 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20111013 ANDA ANDA074253 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 15 mg/1 49349-789_0756d3b5-6c4d-4e63-9130-51282c983e5b 49349-789 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20111017 ANDA ANDA078154 REMEDYREPACK INC. LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-790_021470b9-06d2-411c-908b-9113cf913919 49349-790 HUMAN PRESCRIPTION DRUG Erythrocin Stearate ERYTHROMYCIN STEARATE TABLET, FILM COATED ORAL 20130318 ANDA ANDA060359 REMEDYREPACK INC. ERYTHROMYCIN STEARATE 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 49349-790_4065399f-99da-4b40-b244-9e9fa04c2503 49349-790 HUMAN PRESCRIPTION DRUG Erythrocin Stearate ERYTHROMYCIN STEARATE TABLET, FILM COATED ORAL 20130305 ANDA ANDA060359 REMEDYREPACK INC. ERYTHROMYCIN STEARATE 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 49349-790_b2ee31ad-1492-4584-835d-480d56d0174d 49349-790 HUMAN PRESCRIPTION DRUG Erythrocin Stearate ERYTHROMYCIN STEARATE TABLET, FILM COATED ORAL 20130327 ANDA ANDA060359 REMEDYREPACK INC. ERYTHROMYCIN STEARATE 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 49349-790_caca401c-a433-4c90-8ea7-5873dae3b1a2 49349-790 HUMAN PRESCRIPTION DRUG Erythrocin Stearate ERYTHROMYCIN STEARATE TABLET, FILM COATED ORAL 20130318 ANDA ANDA060359 REMEDYREPACK INC. ERYTHROMYCIN STEARATE 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 49349-791_6707027d-f350-4420-803e-e0a1a161dbc7 49349-791 HUMAN PRESCRIPTION DRUG Tramadal Hydrochloride and Acetaminophen Tramadal Hydrochloride and Acetaminophen TABLET ORAL 20111017 ANDA ANDA077858 REMEDYREPACK INC. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 49349-793_e7bc4389-7c5b-4929-9ea5-290496b891db 49349-793 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20111019 ANDA ANDA086223 REMEDYREPACK INC. ISOSORBIDE DINITRATE 10 mg/1 49349-795_658c1f33-9bb8-4fdc-ab4c-e5681577a0ba 49349-795 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20111020 ANDA ANDA075828 REMEDYREPACK INC. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-796_492fef9f-821f-4e03-9c45-ee5d63b621f3 49349-796 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111019 ANDA ANDA040145 REMEDYREPACK INC. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-797_d078460c-d91d-42f1-af25-4b96b7215288 49349-797 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20130305 ANDA ANDA076268 REMEDYREPACK INC. DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 49349-797_ffff959f-c447-4feb-9d03-e5d1ad1212cc 49349-797 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20130521 ANDA ANDA076268 REMEDYREPACK INC. DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 49349-798_c76a81ad-4780-4187-8256-c42796909a1d 49349-798 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20140414 ANDA ANDA077912 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-798_ccd4a485-b9a1-4381-890d-f06d63c295f0 49349-798 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20111031 ANDA ANDA077912 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-798_d4f43c80-ef60-459b-9b9b-c4f20bd20a6c 49349-798 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20130705 ANDA ANDA077912 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49349-799_28c23cd8-8104-40b4-af73-6ef209e5b7ab 49349-799 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20111031 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-800_13bfa858-f590-41fe-944d-9bb2c70a6134 49349-800 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20111031 ANDA ANDA085475 REMEDYREPACK INC. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49349-801_9b874681-2f1c-4627-8f21-0933ca531a5c 49349-801 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130305 ANDA ANDA076708 REMEDYREPACK INC. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-802_27aef3c4-130a-4fe2-afbd-453c65cfeebf 49349-802 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20111101 ANDA ANDA079162 REMEDYREPACK INC. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-803_553f63b5-1048-4b8e-aa74-b5a51a146785 49349-803 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20111101 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-804_261de3a0-b149-472d-b5bd-9bfe9dafecea 49349-804 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20130722 NDA AUTHORIZED GENERIC NDA020592 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 49349-805_d23f52fc-3f23-4f5c-8cdb-eb68afed7361 49349-805 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20130429 NDA AUTHORIZED GENERIC NDA020592 REMEDYREPACK INC. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 49349-806_faf37389-da14-40d8-b87d-22db4d340770 49349-806 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20111101 ANDA ANDA040350 REMEDYREPACK INC. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 49349-807_a308a83d-3ba9-4146-862b-69612ad49ba1 49349-807 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20130509 NDA NDA021976 REMEDYREPACK INC. DARUNAVIR ETHANOLATE 400 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] 49349-808_06a3ad07-10e6-403b-9c9b-ab0a3a889038 49349-808 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20111110 ANDA ANDA075317 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-809_c9e3e599-a38f-4efb-a178-11a6c775574f 49349-809 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20111115 ANDA ANDA091231 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 49349-810_035cc6d7-d5fd-4434-a8fe-c8152e436ece 49349-810 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET ORAL 20111115 ANDA ANDA077851 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 49349-811_30432d99-0606-4e5f-9ca7-8218ea63e4ad 49349-811 HUMAN PRESCRIPTION DRUG LEXIVA fosamprenavir calcium TABLET, FILM COATED ORAL 20130509 NDA NDA021548 REMEDYREPACK INC. FOSAMPRENAVIR CALCIUM 700 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA] 49349-812_a134ee63-2e0e-4d26-ae1b-f2573533087d 49349-812 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET ORAL 20111115 ANDA ANDA091231 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 49349-812_a4f6a542-a0c6-49cc-b15b-83178d474b8d 49349-812 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET ORAL 20140110 ANDA ANDA091231 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 49349-813_a9e55d53-d049-4232-882c-48961382cb93 49349-813 HUMAN PRESCRIPTION DRUG Thiothixene Thiothixene CAPSULE ORAL 20111114 ANDA ANDA071093 REMEDYREPACK INC. THIOTHIXENE 5 mg/1 Typical Antipsychotic [EPC] 49349-814_8ecd948f-43bb-45b3-9b4d-53edaed56c49 49349-814 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111115 ANDA ANDA040301 REMEDYREPACK INC. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-815_1f6e558e-9175-4f06-9cde-0f87e4481168 49349-815 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111115 ANDA ANDA075124 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-816_4129bf37-3886-4367-9825-3dcbdb60f3c9 49349-816 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20111116 ANDA ANDA075536 REMEDYREPACK INC. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-817_b1285c57-d0eb-4f23-a80c-f934d18a4fb9 49349-817 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET ORAL 20111116 ANDA ANDA070995 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49349-818_d93a7cb5-2624-4300-93d0-17573525064f 49349-818 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111117 NDA NDA022104 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-819_5d23a0c0-6dc9-4cf9-acd8-f5ef783cd01b 49349-819 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20111117 ANDA ANDA040901 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 49349-820_da42c643-f3d1-4901-a25d-864e80d3abf5 49349-820 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20111117 ANDA ANDA090278 REMEDYREPACK INC. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-821_98aa81fa-f77b-4216-9e49-88c2d51eb536 49349-821 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20111117 ANDA ANDA077987 REMEDYREPACK INC. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-822_23ebb4ff-0cfd-421d-8e8b-f8f1476c4448 49349-822 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111130 ANDA ANDA078597 REMEDYREPACK INC. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-823_8966f155-b85e-4a31-af16-aa67312a2d4a 49349-823 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine Butalbital, Acetaminophen, Caffeine TABLET ORAL 20111110 ANDA ANDA040513 REMEDYREPACK INC. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 49349-824_4353cb35-e5a6-4c92-99bc-51ed7a655b30 49349-824 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111130 ANDA ANDA040301 REMEDYREPACK INC. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-825_9ec9239a-ea66-4a5b-b29d-7e973e7bfa5b 49349-825 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20111130 ANDA ANDA077987 REMEDYREPACK INC. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-825_f8afd998-a350-43f8-b6a4-9e4caa17101b 49349-825 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20130521 ANDA ANDA077987 REMEDYREPACK INC. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-826_edbf9dff-b5ee-4513-bb9f-4cf0dbbddb3e 49349-826 HUMAN PRESCRIPTION DRUG Erythromycin Base Base Erythromycin TABLET, FILM COATED ORAL 20130304 ANDA ANDA061621 REMEDYREPACK INC. ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 49349-827_07146532-baf8-4bf7-bace-e3955767800b 49349-827 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20111130 ANDA ANDA072574 REMEDYREPACK INC. PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-828_6b845f93-4097-40ac-9e42-dd0b74a4d7e7 49349-828 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET ORAL 20111130 ANDA ANDA075893 REMEDYREPACK INC. FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-829_cad35dda-ce92-408a-bb54-2c1e64b2e559 49349-829 HUMAN PRESCRIPTION DRUG Ribasphere Ribavirin TABLET ORAL 20111130 ANDA ANDA076203 REMEDYREPACK INC. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 49349-830_6719f194-fd3a-4b56-9f82-4493b792bf9e 49349-830 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20130509 ANDA ANDA040245 REMEDYREPACK INC. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49349-831_295c01ab-6400-49b3-be5d-f94362394bc1 49349-831 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20130730 ANDA ANDA074644 REMEDYREPACK INC. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-831_a011ac8e-19fc-42c1-98be-8b55cf199e59 49349-831 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20111201 ANDA ANDA074644 REMEDYREPACK INC. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49349-832_8aa15fa2-29b6-4f5b-a0a2-ee755fe5e8dd 49349-832 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20111201 ANDA ANDA040349 REMEDYREPACK INC. SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 49349-834_7b84a6f4-03b9-4ed4-a9b9-a94d17b7a2bd 49349-834 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR 20131121 ANDA ANDA077942 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-834_81e46a7b-3dc4-43c7-b7b6-ea9c4c68c9fa 49349-834 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR 20130614 ANDA ANDA077942 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-834_fe35fb9f-1225-4d81-aaa4-da76ca1d353e 49349-834 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR 20131121 ANDA ANDA077942 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-835_85eb4ef1-53e9-4965-9f03-581b34d8c39e 49349-835 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20130613 ANDA ANDA065180 REMEDYREPACK INC. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 49349-836_20d5a4b3-1863-435c-867c-ba372c01dc9f 49349-836 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION INTRAMUSCULAR 20130613 ANDA ANDA080817 REMEDYREPACK INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 49349-837_8eafc3ea-963f-45cc-bba9-a5811ba37376 49349-837 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR 20131213 ANDA ANDA077942 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-837_dcdd5218-e6e6-4628-a2e4-49f161341cef 49349-837 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR 20130614 ANDA ANDA077942 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-837_f56bcf5f-d0ea-455b-8dba-e17450a51c5f 49349-837 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR 20131121 ANDA ANDA077942 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-838_1eac23b4-b697-4754-ad26-5a494a157370 49349-838 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET ORAL 20130509 ANDA ANDA090092 REMEDYREPACK INC. ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-839_52031698-b9e4-478c-a073-ac9f84f3c50f 49349-839 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20130308 ANDA ANDA090467 REMEDYREPACK INC. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49349-840_c6c0d851-3084-493b-8dd6-736bbded4fe0 49349-840 HUMAN PRESCRIPTION DRUG Solu-Medrol Methylprednisolone Sodium Succinate POWDER, FOR SOLUTION INTRAVENOUS 20111219 NDA NDA011856 REMEDYREPACK INC. METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49349-841_05548b30-f1fc-42d4-b99c-c66e9c594eb7 49349-841 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR 20131211 ANDA ANDA084916 REMEDYREPACK INC. DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49349-841_155c37a9-f3cb-42c3-8ed4-91ad1771fcd4 49349-841 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR 20131118 ANDA ANDA084916 REMEDYREPACK INC. DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49349-841_269d3e20-9c64-42f0-b039-568b7e3941bf 49349-841 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR 20131223 ANDA ANDA084916 REMEDYREPACK INC. DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49349-842_08706642-8587-4b93-9ab6-c481d510338e 49349-842 HUMAN PRESCRIPTION DRUG Haloperidol HALOPERIDOL LACTATE INJECTION, SOLUTION INTRAMUSCULAR 20131119 ANDA ANDA075689 REMEDYREPACK INC. HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] 49349-842_7d1d162f-af8b-484a-b997-dfa3f4227c8a 49349-842 HUMAN PRESCRIPTION DRUG Haloperidol HALOPERIDOL LACTATE INJECTION, SOLUTION INTRAMUSCULAR 20131119 ANDA ANDA075689 REMEDYREPACK INC. HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] 49349-842_afd79a7a-4b4a-41b4-ac93-dbb8e20757a8 49349-842 HUMAN PRESCRIPTION DRUG Haloperidol HALOPERIDOL LACTATE INJECTION, SOLUTION INTRAMUSCULAR 20130613 ANDA ANDA075689 REMEDYREPACK INC. HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] 49349-843_8d7f19c2-e7ef-4f96-bc85-9d13f92a16f3 49349-843 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20111201 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-844_93439229-179f-42cb-ace9-cb3b8ed76db9 49349-844 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20130422 ANDA ANDA076000 REMEDYREPACK INC. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 49349-845_34da5bb5-2f8a-4986-a864-1ccd2d60ba3c 49349-845 HUMAN PRESCRIPTION DRUG Ultram ER Tramadol Hydrochloride TABLET ORAL 20120301 NDA NDA021692 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 49349-847_304e340f-cec1-4f9a-81b5-d99347ce59fd 49349-847 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20131203 ANDA ANDA075967 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-847_c05dacd5-b4b8-461c-ae81-2215e7723581 49349-847 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20111202 ANDA ANDA075967 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-847_f2a64b51-ca39-4e10-a3fd-3b366c54ab42 49349-847 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130530 ANDA ANDA075967 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49349-848_84114522-14c5-4658-acc7-813a8c3a80a4 49349-848 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20111202 ANDA ANDA200651 REMEDYREPACK INC. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-849_0ac34a25-69c3-44b6-b303-45e52d877fde 49349-849 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20130501 ANDA ANDA076000 REMEDYREPACK INC. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 49349-850_3aad2522-54a1-41b6-bf9d-aacc9a20701f 49349-850 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20111202 ANDA ANDA075991 REMEDYREPACK INC. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-850_6c548603-9e5a-49bb-a2dd-c9c57d4eaafe 49349-850 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130520 ANDA ANDA075991 REMEDYREPACK INC. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-850_8c9cba22-4962-463c-99d0-af87b344f209 49349-850 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20131105 ANDA ANDA075991 REMEDYREPACK INC. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-851_8a23eea8-1941-485b-a62d-1d7f4b15ee0f 49349-851 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20111202 ANDA ANDA091231 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 49349-852_89f018ba-a684-48a6-9498-d2a71b18e16c 49349-852 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111202 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-853_520edf05-014f-4232-ad47-00b45fcfac97 49349-853 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20111205 ANDA ANDA090485 REMEDYREPACK INC. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 49349-854_042202f0-c38f-4677-81c7-d10b1719ad59 49349-854 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET ORAL 20111212 ANDA ANDA076639 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49349-855_55efe338-03a5-4cc7-93f6-4c5f44e51468 49349-855 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130301 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 49349-856_e779fb95-8242-44bf-9b96-2f6d889b4c6a 49349-856 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20111222 ANDA ANDA080356 REMEDYREPACK INC. PREDNISONE 5 mg/1 49349-857_7c1cb1ce-806c-4c24-b1e5-0505130e44b0 49349-857 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20130510 ANDA ANDA078947 REMEDYREPACK INC. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-858_ccb8f9ef-3d53-4bc8-997e-0157827800cb 49349-858 HUMAN PRESCRIPTION DRUG Zofran Ondansetron Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20111219 NDA NDA020781 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 49349-859_c4642275-cfd6-46f9-b7cf-270e4c9b02ae 49349-859 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20111228 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-860_d85dec63-34f2-4cd3-95ca-df8e02d70d28 49349-860 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20111219 ANDA ANDA076077 REMEDYREPACK INC. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 49349-861_06a957d8-fade-4c6a-bae4-f3f3d21e72e4 49349-861 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111219 ANDA ANDA090935 REMEDYREPACK INC. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-862_0d357602-6369-40e7-a680-783d0df13c71 49349-862 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20130422 ANDA ANDA078938 REMEDYREPACK INC. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-862_891a29ef-1577-4389-afa2-220c84d22239 49349-862 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20140108 ANDA ANDA078938 REMEDYREPACK INC. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-862_e5f22da0-f6c1-48b9-8969-5da998998451 49349-862 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20130910 ANDA ANDA078938 REMEDYREPACK INC. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49349-864_aed70898-584b-43f7-8a40-d2e322861c7f 49349-864 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20111228 ANDA ANDA077731 REMEDYREPACK INC. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 49349-865_3fc605a8-5000-40b3-aa0e-4ba92f66127a 49349-865 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20120117 ANDA ANDA070789 REMEDYREPACK INC. DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 49349-866_899375f3-2411-47b4-b861-12e813c47f16 49349-866 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20130415 ANDA ANDA078947 REMEDYREPACK INC. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-867_2d04b552-6e5f-460c-b954-e90b5c4714a5 49349-867 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20130415 ANDA ANDA077267 REMEDYREPACK INC. ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-867_83e7bd5b-767a-4026-b771-4553ede02680 49349-867 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20130415 ANDA ANDA077267 REMEDYREPACK INC. ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-867_c2822057-28df-4e31-8711-bae23fced03e 49349-867 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20130415 ANDA ANDA077267 REMEDYREPACK INC. ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-867_ce1bb40c-ccc3-4b0d-99a1-09134acf1950 49349-867 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20130415 ANDA ANDA077267 REMEDYREPACK INC. ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-869_29c3726c-6708-4c7d-ab23-548940db6451 49349-869 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130510 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 49349-870_b40acfc1-ae87-4ac2-a0d6-770802f6e320 49349-870 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20120117 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 49349-872_4c8333ff-e257-49bf-a7f6-e8e3a2f042fb 49349-872 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 20130617 NDA NDA020998 REMEDYREPACK INC. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-872_62f119d0-71cd-4b2c-811c-80e788226e2d 49349-872 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 20130301 NDA NDA020998 REMEDYREPACK INC. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-872_7db5b460-c70c-4e1b-8354-74797eabef10 49349-872 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 20131204 NDA NDA020998 REMEDYREPACK INC. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-872_9f765d70-a463-48ae-b087-67bfe7b0e8ff 49349-872 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 20130220 NDA NDA020998 REMEDYREPACK INC. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-872_dd371627-b99b-4325-bc22-3f267adec0be 49349-872 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 20130529 NDA NDA020998 REMEDYREPACK INC. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-872_eef91012-8f54-4fea-9641-a31914cc441a 49349-872 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 20130221 NDA NDA020998 REMEDYREPACK INC. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-873_41f01575-3855-4b73-8b26-898ecca53f38 49349-873 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20131205 ANDA ANDA091549 REMEDYREPACK INC. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-873_65b3c2ad-28dd-4419-a6d9-3fa26232bf5e 49349-873 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20120301 ANDA ANDA091549 REMEDYREPACK INC. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-873_69740618-41d5-4350-a09e-1651a36fae13 49349-873 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20131211 ANDA ANDA091549 REMEDYREPACK INC. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-878_e5ee9418-29fb-48b7-a7f2-c4910350d984 49349-878 HUMAN PRESCRIPTION DRUG PHENADOZ Promethazine Hydrochloride SUPPOSITORY RECTAL 20130514 ANDA ANDA040479 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 49349-881_5c1648ad-d4ef-47f3-94a5-fd9b9574361d 49349-881 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin Anhydrous TABLET ORAL 20120112 ANDA ANDA065405 REMEDYREPACK INC. AZITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 49349-883_1695e2cf-09ff-45fb-ab5c-cff1918c6d06 49349-883 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20131205 NDA NDA021134 REMEDYREPACK INC. NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 49349-883_f0565ecf-042f-4c0d-ab87-5f24515b01ed 49349-883 HUMAN PRESCRIPTION DRUG Nitrostat Nitroglycerin TABLET ORAL 20120302 NDA NDA021134 REMEDYREPACK INC. NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 49349-884_37ae94b3-06e5-4203-84b4-f0fa718fadd8 49349-884 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 20120301 ANDA ANDA040189 REMEDYREPACK INC. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49349-885_10609f68-4520-40d1-9b57-8baecca6940b 49349-885 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20130411 ANDA ANDA202032 REMEDYREPACK INC. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-885_221e724e-3122-4367-8c30-15935083d57e 49349-885 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20130411 ANDA ANDA202032 REMEDYREPACK INC. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-885_27909df8-20ee-40ed-b058-832bd267a491 49349-885 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20130411 ANDA ANDA202032 REMEDYREPACK INC. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-886_8224bc79-45f1-4f3c-9b39-1850a8f2cd32 49349-886 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET, FILM COATED ORAL 20130409 ANDA ANDA090370 REMEDYREPACK INC. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-887_0db04b9c-e455-4acb-b858-627b349cbff2 49349-887 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20130306 ANDA ANDA076048 REMEDYREPACK INC. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 49349-887_5c08f49c-a7f2-42a8-b255-ee98afcf2c5b 49349-887 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20130408 ANDA ANDA076048 REMEDYREPACK INC. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 49349-888_fe3f2edb-4c5c-48bb-aedf-de0c8c5aad7b 49349-888 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20120302 ANDA ANDA077863 REMEDYREPACK INC. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-889_90503f3d-1959-4ac9-93b4-aed07ec1fb2d 49349-889 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20120305 ANDA ANDA076554 REMEDYREPACK INC. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 49349-890_6246a830-6e72-4645-9b92-dfc81568d2d3 49349-890 HUMAN PRESCRIPTION DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20130520 ANDA ANDA076447 REMEDYREPACK INC. FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 49349-890_8daadede-2176-407b-8244-66d886a82a7b 49349-890 HUMAN PRESCRIPTION DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20131204 ANDA ANDA076447 REMEDYREPACK INC. FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 49349-891_7b3b63ae-d9b0-4628-a487-ec039ea7fb74 49349-891 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120305 ANDA ANDA078218 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49349-891_9f8fa8d8-6859-406f-ac53-f2955ea7646a 49349-891 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20130524 ANDA ANDA078218 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49349-891_a030c8f5-6363-401e-98bc-91b29d36ec67 49349-891 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20130603 ANDA ANDA078218 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49349-891_fc3209d7-7e33-4533-9dce-338891514643 49349-891 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20130603 ANDA ANDA078218 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49349-892_0db21a5f-d68b-4e0b-889b-cc6b0e2411ae 49349-892 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20130221 ANDA ANDA077253 REMEDYREPACK INC. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 49349-892_9b321962-f5f6-4b4b-8a69-fd48dfa7d402 49349-892 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20120305 ANDA ANDA077253 REMEDYREPACK INC. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 49349-894_bbb8ca95-5333-4e6d-81cb-1f444137ee5f 49349-894 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130402 ANDA ANDA077285 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49349-894_c933318b-d45b-4d7b-b655-ac9f48c96841 49349-894 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120305 ANDA ANDA077285 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49349-895_483b2450-cec4-469e-a540-15c635694df1 49349-895 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20120307 ANDA ANDA073281 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-896_7fb959d3-abdc-4b0c-bac3-005df7b8d09e 49349-896 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20130411 ANDA ANDA079081 REMEDYREPACK INC. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-896_df23678d-7a1c-4c7a-a7f6-39719f7ecfea 49349-896 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20130411 ANDA ANDA079081 REMEDYREPACK INC. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-897_87251a5c-6361-47cf-93d2-6b09929cfdaa 49349-897 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20120307 ANDA ANDA077253 REMEDYREPACK INC. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 49349-897_881e33d6-1da7-4c73-8ba8-c9cd15d778a8 49349-897 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20130315 ANDA ANDA077253 REMEDYREPACK INC. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 49349-898_d041db75-0fc6-434a-8620-a610604c9d34 49349-898 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20120307 ANDA ANDA200651 REMEDYREPACK INC. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-899_7834dbd8-412f-4c9d-9b59-0e4be0e5f1be 49349-899 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20120307 ANDA ANDA077397 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-900_ae14e969-a7c4-48e1-a2a2-6b81d4539106 49349-900 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20130509 ANDA ANDA078947 REMEDYREPACK INC. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-901_9122398e-ac47-41f9-9d1e-d8117a245747 49349-901 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20130509 ANDA ANDA040301 REMEDYREPACK INC. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49349-902_19465030-2081-4cd5-bd7f-2eec019e3738 49349-902 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20130509 NDA NDA020639 REMEDYREPACK INC. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 49349-903_8b2fc961-bf53-4649-8601-187e7dac3387 49349-903 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20120312 ANDA ANDA090200 REMEDYREPACK INC. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49349-904_e2e6f5b2-a081-48af-96d0-d92908421bf1 49349-904 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20120312 ANDA ANDA078069 REMEDYREPACK INC. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-905_b034da3a-ee5d-4edf-b5d7-471efb8fff2a 49349-905 HUMAN PRESCRIPTION DRUG ZIAGEN abacavir sulfate TABLET, FILM COATED ORAL 20130408 NDA NDA020977 REMEDYREPACK INC. ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49349-906_51c18702-ee77-46fd-8381-cbf540ba909c 49349-906 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20130301 ANDA ANDA080212 REMEDYREPACK INC. ISONIAZID 300 mg/1 Antimycobacterial [EPC] 49349-907_ecae756a-f7ac-4c9d-9e24-b2aaf1c8e78d 49349-907 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20120312 ANDA ANDA079162 REMEDYREPACK INC. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-908_8a0b5e67-0d84-48c4-a053-1fe0444b5315 49349-908 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130514 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 49349-909_4af8cb5c-d97f-4a0e-ad17-fb1098dd1d57 49349-909 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol INJECTION INTRAMUSCULAR 20130410 NDA AUTHORIZED GENERIC NDA015923 REMEDYREPACK INC. HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 49349-910_559e2186-2de7-4b04-a0a3-3be7fe08f444 49349-910 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20131211 ANDA ANDA072234 REMEDYREPACK INC. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 49349-910_a47dc343-3c1d-4622-8b91-2407c7431296 49349-910 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20120313 ANDA ANDA072234 REMEDYREPACK INC. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 49349-910_f13c1a4a-f38c-475f-bd83-ec6a3c960e5c 49349-910 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20131211 ANDA ANDA072234 REMEDYREPACK INC. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 49349-911_39e682f8-88e9-4a99-952e-13462e0b87c6 49349-911 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20130422 ANDA ANDA078947 REMEDYREPACK INC. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-912_bb8d0fe3-a6e1-4219-8cfb-1dc27d995978 49349-912 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20120314 ANDA ANDA040337 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 49349-913_a93876f0-9ccb-496e-a703-6103f0fedfa0 49349-913 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120314 NDA AUTHORIZED GENERIC NDA020699 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-914_77588378-a46c-4289-8e1d-7fab17127ec3 49349-914 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20130218 ANDA ANDA077397 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-914_ab360e62-7560-4eff-83c6-53ae045f56ed 49349-914 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20130327 ANDA ANDA077397 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-914_b0865f86-5dd9-4fa3-a07f-fb902cfeaa4e 49349-914 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20130521 ANDA ANDA077397 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-914_fe55762c-db4e-403d-a029-f3f3c07898cb 49349-914 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20120314 ANDA ANDA077397 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-915_a600f3a2-cd26-4a3f-a455-d49f635ff7fd 49349-915 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20120314 ANDA ANDA084769 REMEDYREPACK INC. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49349-916_79d50f43-15af-483f-af90-81bda2222fa6 49349-916 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20120315 ANDA ANDA074584 REMEDYREPACK INC. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 49349-917_ec5820d6-fe35-4987-8177-9cba915aecd8 49349-917 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAVENOUS 20130813 ANDA ANDA040803 REMEDYREPACK INC. DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49349-922_9af68e04-5a16-435f-9b1a-f5043c1b4411 49349-922 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20130410 ANDA ANDA078925 REMEDYREPACK INC. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49349-923_80dcc8bf-6d87-4cb7-b5b9-d4a68dfb7f95 49349-923 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20120315 ANDA ANDA040412 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-923_a34461d2-a4a1-4eae-87e8-5f5e90297a53 49349-923 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130521 ANDA ANDA040412 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49349-924_22474146-7a1f-4443-918d-dcd00d71ef28 49349-924 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20130501 ANDA ANDA090705 REMEDYREPACK INC. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-924_a5bb7f4d-6628-4e96-b9f1-b1061d4a9b3c 49349-924 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20131015 ANDA ANDA090705 REMEDYREPACK INC. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-924_f69bf8dc-6472-4fce-9642-54fbcff8053e 49349-924 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20120316 ANDA ANDA090705 REMEDYREPACK INC. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-925_a034cd8a-28bc-46ef-8d36-b1a6a81c58c3 49349-925 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20130514 ANDA ANDA078155 REMEDYREPACK INC. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-926_9e9e08f4-39c5-4a97-b4db-860370f516af 49349-926 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20120322 ANDA ANDA089828 REMEDYREPACK INC. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 CIII 49349-927_a5b9e2c3-cf70-4154-8f50-bb95b10ef9e0 49349-927 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20120322 ANDA ANDA090705 REMEDYREPACK INC. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-927_e5bea8bb-5bcc-41fb-a589-1dffd93cbafe 49349-927 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20130521 ANDA ANDA090705 REMEDYREPACK INC. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-928_87e03ac4-ddd6-40bd-b39e-1127400bc67b 49349-928 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20130520 ANDA ANDA090705 REMEDYREPACK INC. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-928_b3bf27d8-e85e-4854-946e-6e1ace7a91c4 49349-928 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20120323 ANDA ANDA090705 REMEDYREPACK INC. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-929_e21895ce-f310-4b09-ab0f-dba873257cf7 49349-929 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 20120323 ANDA ANDA080172 REMEDYREPACK INC. PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 49349-930_f535c158-64f1-4261-978a-209c72359404 49349-930 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130411 ANDA ANDA091272 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-931_a3102f3d-3c7a-4b6e-ab6a-1239125d67f2 49349-931 HUMAN PRESCRIPTION DRUG Olanzapine OLANZAPINE TABLET, FILM COATED ORAL 20121213 ANDA ANDA076000 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 49349-932_8cc96ec5-b9cc-4b2c-9238-058dc9d0a558 49349-932 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20130726 ANDA ANDA076119 REMEDYREPACK INC. MIRTAZAPINE 15 mg/1 49349-932_d472aad9-b87e-4085-a8eb-2825b7cf8dd2 49349-932 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20120326 ANDA ANDA076119 REMEDYREPACK INC. MIRTAZAPINE 15 mg/1 49349-933_1d4eeaac-0360-4160-b006-36036f835097 49349-933 HUMAN PRESCRIPTION DRUG Benztropine Mesylate BENZTROPINE MESYLATE TABLET ORAL 20121113 ANDA ANDA040742 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 49349-937_7cced4fd-0b8f-4842-afb7-b04e572fd43e 49349-937 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20120327 ANDA ANDA074514 REMEDYREPACK INC. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-938_22db0742-7cf2-4b26-a04b-1fc0c6a4626a 49349-938 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130501 ANDA ANDA090200 REMEDYREPACK INC. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49349-938_86b80690-9752-4449-96fa-9d6f8e3a2481 49349-938 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20120327 ANDA ANDA090200 REMEDYREPACK INC. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49349-939_421d35c0-740c-4760-ade2-06af9f25a255 49349-939 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, EXTENDED RELEASE ORAL 20120328 ANDA ANDA075910 REMEDYREPACK INC. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-940_9e9e5381-a1a7-4e12-8109-bf0d869b9f99 49349-940 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130409 ANDA ANDA075991 REMEDYREPACK INC. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-941_25899197-e9d7-4f01-baeb-a4b7fcea5ad0 49349-941 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20120329 ANDA ANDA075022 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 30 mg/1 49349-942_a40d8474-9b8f-4d60-b5dd-25bc95438bc0 49349-942 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20120329 ANDA ANDA090278 REMEDYREPACK INC. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-943_689f6673-16ac-4303-b419-9fc46cbd092e 49349-943 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20130411 NDA NDA016677 REMEDYREPACK INC. SODIUM CHLORIDE 9 g/1 49349-944_d5704edf-d1e7-40e5-b5e6-f4e93c1d37c5 49349-944 HUMAN PRESCRIPTION DRUG Lactated Ringers Sodium chloride, potassium chloride, sodium lactate and calcium chloride INJECTION, SOLUTION INTRAVENOUS 20130530 NDA NDA016682 REMEDYREPACK INC. CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE 20; 30; 600; 310 mg/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 49349-945_67aa9143-7e91-4ce2-94d3-bf47d7938470 49349-945 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20120329 NDA NDA013217 REMEDYREPACK INC. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49349-946_acee238b-9131-4bd7-bb17-f8e4c86babe0 49349-946 HUMAN PRESCRIPTION DRUG KENALOG-40 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRAMUSCULAR 20130411 NDA NDA014901 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 40 mg/1 49349-947_da4e461e-becb-4654-9b8c-be512c4e36ee 49349-947 HUMAN PRESCRIPTION DRUG KENALOG-40 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRAMUSCULAR 20130411 NDA NDA014901 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 40 mg/1 49349-948_846c9a74-8dff-4cab-a99f-7c7c5a53c58a 49349-948 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRAMUSCULAR 20130410 NDA NDA011757 REMEDYREPACK INC. METHYLPREDNISOLONE ACETATE 40 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49349-949_ea38282e-ba5e-4a0c-b716-c380c9c3f8f8 49349-949 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20120329 ANDA ANDA062031 REMEDYREPACK INC. DOXYCYCLINE HYCLATE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 49349-950_7f1cfab8-e8e0-4527-86b5-93458cc0a8eb 49349-950 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130220 ANDA ANDA076765 REMEDYREPACK INC. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-950_f25bc555-1bd1-4902-96c5-dfe8e3a38859 49349-950 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130218 ANDA ANDA076765 REMEDYREPACK INC. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-951_170cef33-d3a1-483e-933a-af01ebc57273 49349-951 HUMAN PRESCRIPTION DRUG Asacol Asacol TABLET, DELAYED RELEASE ORAL 20120330 NDA NDA019651 REMEDYREPACK INC. MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 49349-951_2facfcc3-ebcb-40d3-ab0c-b736620433f3 49349-951 HUMAN PRESCRIPTION DRUG Asacol Asacol TABLET, DELAYED RELEASE ORAL 20130729 NDA NDA019651 REMEDYREPACK INC. MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 49349-952_1503b623-b4b1-4c64-8787-278a696282c6 49349-952 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130213 ANDA ANDA076765 REMEDYREPACK INC. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-952_2cfd8926-6403-4cb4-9d70-76b1c36e4cd5 49349-952 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130408 ANDA ANDA076765 REMEDYREPACK INC. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-953_02690a95-c883-4519-8110-0ad8d695a642 49349-953 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130725 ANDA ANDA077565 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 49349-953_b9725fda-fcae-49ca-bbeb-f2cd52a69b79 49349-953 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130208 ANDA ANDA077565 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 49349-954_54a33fce-9e0b-4ef8-afc8-4e0d65c85eb4 49349-954 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130208 ANDA ANDA077565 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 49349-954_f1490ad6-a348-44e0-af65-b589dc5fd463 49349-954 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130408 ANDA ANDA077565 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 49349-955_f7325c28-5836-424b-a406-804af8a06e2c 49349-955 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET ORAL 20120330 ANDA ANDA075219 REMEDYREPACK INC. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49349-957_5f23111a-db12-4dd6-9e19-1cdf168ab5b0 49349-957 HUMAN PRESCRIPTION DRUG Medrol methylprednisolone TABLET ORAL 20130219 NDA NDA011153 REMEDYREPACK INC. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49349-960_51fa2c5c-b268-4e4a-bfeb-b312544c4649 49349-960 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20130215 ANDA ANDA075347 REMEDYREPACK INC. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 49349-961_86feed36-85fa-468e-a876-7cb3cea0e149 49349-961 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20130207 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 49349-962_801f60ec-4db2-451d-922d-60bca834eb14 49349-962 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20130207 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 49349-963_0cfb9ac7-4617-4faf-99c9-df606f54c3c5 49349-963 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20130207 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 49349-964_a00401f4-6dee-4e9d-b71d-97072dbabf69 49349-964 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20130218 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 49349-965_7e45f2dd-a9f1-4523-95c6-e8bead7a70a7 49349-965 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20130215 ANDA ANDA090705 REMEDYREPACK INC. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-966_79b707f9-5777-4558-bcfc-32597da09c58 49349-966 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE TABLET ORAL 20120917 ANDA ANDA085969 REMEDYREPACK INC. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 49349-967_5a0df2b0-0252-488e-a358-57bf169ab63f 49349-967 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20130208 ANDA ANDA075350 REMEDYREPACK INC. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-969_bc82148d-5be6-4a2f-8243-4cad762967d0 49349-969 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 20120710 ANDA ANDA040189 REMEDYREPACK INC. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49349-970_703daadc-d04d-4a09-a591-1eb9d24918eb 49349-970 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20120710 NDA NDA018764 REMEDYREPACK INC. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 49349-970_a8d16780-5c28-4c7e-830c-1a9f45d084ad 49349-970 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20130924 ANDA ANDA070044 REMEDYREPACK INC. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 49349-971_e2a78c7e-43be-4dc7-a7f7-2789127a022f 49349-971 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130208 ANDA ANDA079132 REMEDYREPACK INC. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-972_94496109-829c-4e76-82fc-69ca7cc10079 49349-972 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20120910 ANDA ANDA076921 REMEDYREPACK INC. MIRTAZAPINE 15 mg/1 49349-973_c6fdab14-b43f-45af-bef0-8bf289b52243 49349-973 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20130215 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 49349-974_98626547-a5bd-4aac-ac45-21d7d2600007 49349-974 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20130208 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 49349-975_2fcc651e-50ff-4fe5-8700-c4a6e391d4a5 49349-975 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20130215 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 49349-976_85c2bb32-93c1-48c8-bec3-6f54500c2cec 49349-976 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20130208 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 49349-977_78a315f7-0ce3-4eb3-84cb-c570a29f5f21 49349-977 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20130208 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 49349-978_c72246db-0b9b-4916-85d0-c3795660ee1b 49349-978 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130208 ANDA ANDA077565 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 49349-979_45d25a17-94fd-4bd9-9e2e-780f78344ba3 49349-979 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20140519 ANDA ANDA077565 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 49349-979_65332323-0aa2-4b73-8a66-5f0d155f6fda 49349-979 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130215 ANDA ANDA077565 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 49349-980_699978a6-93b0-435b-93e1-b1793d83c164 49349-980 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20131231 ANDA ANDA202050 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 49349-980_6f001096-e3ec-4dc3-8f36-b9da02c2230a 49349-980 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20130624 ANDA ANDA202050 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 49349-980_dab20909-1c6c-4686-908c-51244afc880d 49349-980 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20130401 ANDA ANDA202050 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 49349-981_481ebf91-1065-451b-8811-7621abaac224 49349-981 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20130401 ANDA ANDA202050 REMEDYREPACK INC. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 49349-981_df4b16c7-9565-41da-a80b-61520cd7efd4 49349-981 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20130401 ANDA ANDA202050 REMEDYREPACK INC. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 49349-982_2481261e-f53c-49dc-9e5b-076803d8ed63 49349-982 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130213 ANDA ANDA075991 REMEDYREPACK INC. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-982_b8ce7ca4-b67d-48b5-8157-a175136ce65b 49349-982 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130521 ANDA ANDA075991 REMEDYREPACK INC. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-982_f57ad42e-495c-4003-8712-426206f69e3e 49349-982 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20131105 ANDA ANDA075991 REMEDYREPACK INC. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-983_e3ac338d-6d6d-4f1a-8c47-83d9a51b0dec 49349-983 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20120710 ANDA ANDA090200 REMEDYREPACK INC. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49349-984_d3bff759-6140-40b9-9908-22b758511756 49349-984 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20130208 ANDA ANDA091231 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 49349-985_3cff27db-df11-411b-bf17-0a66f3b4ce7a 49349-985 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130215 ANDA ANDA075828 REMEDYREPACK INC. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-986_4a904597-8b9c-47b8-a07b-fcdb32f1983b 49349-986 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20120911 ANDA ANDA075991 REMEDYREPACK INC. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49349-987_1d4fd494-ac58-418a-a333-75b241371314 49349-987 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20130221 ANDA ANDA075382 REMEDYREPACK INC. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49349-988_664308f9-e53f-4b41-b555-3c7b79833651 49349-988 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20130215 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49349-989_f2bce535-97fa-4c56-9fc6-ce1083186724 49349-989 HUMAN PRESCRIPTION DRUG Metronidazole METRONIDAZOLE TABLET ORAL 20120911 ANDA ANDA070035 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 49349-990_a8206c5f-aaa5-4025-9cd4-808ec14d2078 49349-990 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET ORAL 20130220 ANDA ANDA090844 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 49349-991_7c7c429c-14f9-4c4d-b1a6-2a2782aaf8ab 49349-991 HUMAN PRESCRIPTION DRUG FLuvoxamine Maleate FLUVOXAMINE MALEATE TABLET ORAL 20121015 NDA NDA021519 REMEDYREPACK INC. FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49349-993_a3e52b5b-ebdd-4454-85f0-adebc51ceec3 49349-993 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20130220 ANDA ANDA079162 REMEDYREPACK INC. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49349-994_81e300b6-5778-4481-8c7f-a2fddf4e7973 49349-994 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20130220 ANDA ANDA040144 REMEDYREPACK INC. HYDROCODONE BITARTRATE 5 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 49349-995_bc868a54-a3fe-4e3a-a283-03ca6b1f8899 49349-995 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET ORAL 20130218 ANDA ANDA090844 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 49349-996_07d8241e-7a5d-4ae8-afac-c6e31783df55 49349-996 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130329 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 49349-996_b6e969b0-a225-48c2-9cd3-b1b3cef3769d 49349-996 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130401 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 49349-997_168d191a-dbc1-434b-9240-b89191557d39 49349-997 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20120913 ANDA ANDA083677 REMEDYREPACK INC. PREDNISONE 20 mg/1 49349-998_54b31b97-9c52-4d08-aa75-665f80b387c8 49349-998 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130227 ANDA ANDA079132 REMEDYREPACK INC. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49349-999_fa1899b5-af44-46da-897c-2db5bc1e02c4 49349-999 HUMAN PRESCRIPTION DRUG Abacavir Sulfate abacavir sulfate TABLET, FILM COATED ORAL 20130227 ANDA ANDA091294 REMEDYREPACK INC. ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49351-015_ecd79636-6f9a-4652-8ea5-d25f4dfa8900 49351-015 HUMAN OTC DRUG Tork Premium Triclosan LIQUID TOPICAL 20100303 OTC MONOGRAPH NOT FINAL part333 SCA Tissue North America TRICLOSAN .5 g/100mL 49351-016_9f2186c0-1be3-4d63-bc13-281ebd9b263f 49351-016 HUMAN OTC DRUG Tork Premium Hand Sanitizer Foam Alcohol-Free Benzalkonium Chloride LIQUID TOPICAL 20100303 OTC MONOGRAPH NOT FINAL part333 SCA Tissue North America BENZALKONIUM CHLORIDE .1 g/100mL 49351-018_31c9f4b2-be43-406a-960f-35ee4443b9fe 49351-018 HUMAN OTC DRUG Tork Premium Hand Sanitizer Foam Alcohol LIQUID TOPICAL 20100423 OTC MONOGRAPH NOT FINAL part333 SCA Tissue North America ALCOHOL 67 mL/100mL 49351-101_ac7515ec-a0de-4f40-98a8-5682c6a234c5 49351-101 HUMAN OTC DRUG Tork Hand Sanitizer Alcohol Gel Ethyl alcohol GEL TOPICAL 20140430 OTC MONOGRAPH NOT FINAL part333E SCA Tissue North America ALCOHOL 76 mL/100mL 49351-103_a837515b-1ca5-47fc-925e-a5f2d8a486c9 49351-103 HUMAN OTC DRUG Tork Hand Sanitizer Alcohol Free Foam Benzalkonium Chloride LIQUID TOPICAL 20140812 OTC MONOGRAPH NOT FINAL part333E SCA Tissue North America BENZALKONIUM CHLORIDE .13 g/100mL 49351-200_6cb55253-4edb-4482-87c6-17bd26a81ad7 49351-200 HUMAN OTC DRUG Tork Hand Sanitizer Alcohol Foam Ethyl alcohol liquid LIQUID TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part333E SCA Tissue North America ALCOHOL .72 mL/mL 49351-400_eaa40298-74e9-4b4b-a2dc-2875005d2ade 49351-400 HUMAN OTC DRUG Tork Premium Antibacterial Triclosan SOAP TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333 SCA Tissue North America TRICLOSAN .3 mg/100mL 49351-700_da64d406-458d-4f1e-b5ac-699b7bb91867 49351-700 HUMAN OTC DRUG Tork Advanced Antimicrobial Parachlorometaxylenol SOAP TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333 SCA Tissue North America CHLOROXYLENOL .3 mg/100mL 49358-541_79924b9a-f6df-42f3-81ef-12d2ece358b0 49358-541 HUMAN OTC DRUG MDSolarSCIENCES Natural Mineral Sunscreen TITANIUM DIOXIDE and ZINC OXIDE LIPSTICK TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MD Solar Sciences TITANIUM DIOXIDE; ZINC OXIDE .96; .792 g/12g; g/12g 49358-542_c47ce0df-897a-40c0-9ce7-2731f2eb41b7 49358-542 HUMAN OTC DRUG MDSolarSciences Natural Mineral Sunscreen Tinted TITANIUM DIOXIDE and ZINC OXIDE GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MD Solar Sciences TITANIUM DIOXIDE; ZINC OXIDE 2.7; 1.33 g/35g; g/35g 49358-543_513e7f65-9bdf-405b-95ea-1761da4fe96a 49358-543 HUMAN OTC DRUG MDSOLARSCIENCES Natural Mineral Sunscreen Kid Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MD Solar Sciences TITANIUM DIOXIDE; ZINC OXIDE 6.16; 3.04 g/80g; g/80g 49358-544_e8b49e5d-db0c-44d0-a435-4bde9abcf38a 49358-544 HUMAN OTC DRUG MDSolarSciences SPF 40 Quick Dry Avobenzone, Octisalate, and Octocrylene SPRAY TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MD Solar Sciences AVOBENZONE; OCTISALATE; OCTOCRYLENE 4.44; 7.4; 4.07 mL/148mL; mL/148mL; mL/148mL 49358-545_f7b7e9ac-e198-4ed5-a5d4-ac83e5f244b0 49358-545 HUMAN OTC DRUG MDSolarSciences Natural Mineral Sunscreen Titanium Dioxide and Zinc Oxide LIPSTICK TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MD Solar Sciences TITANIUM DIOXIDE; ZINC OXIDE .96; .792 g/12g; g/12g 49358-546_bed494be-e4a1-4c46-8341-eee1a25f4cf8 49358-546 HUMAN OTC DRUG MDSOLARSCIENCES SPF 50 Mineral TITANIUM DIOXIDE and Zinc Oxide CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part352 MD Solar Sciences TITANIUM DIOXIDE; ZINC OXIDE 15; 170 mg/g; mg/g 49358-547_9c34386d-83b4-451f-a798-c818b43dfe44 49358-547 HUMAN OTC DRUG MDSOLARSCIENCES SPF 30 Mineral Tinted TITANIUM DIOXIDE and Zinc Oxide CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part352 MD Solar Sciences TITANIUM DIOXIDE; ZINC OXIDE 15; 170 mg/g; mg/g 49358-548_c0669e4f-4fd4-42ab-8c09-151ef9775e96 49358-548 HUMAN OTC DRUG MDSOLARSCIENCES SPF 50 Mineral TITANIUM DIOXIDE and Zinc Oxide LOTION TOPICAL 20130201 OTC MONOGRAPH FINAL part352 MD Solar Sciences TITANIUM DIOXIDE; ZINC OXIDE 30; 150 mg/g; mg/g 49358-549_312099f4-da7b-45b0-a478-bbb84915d19c 49358-549 HUMAN OTC DRUG MDSOLARSCIENCES Daily Anti Aging Moisturizer SPF 30 Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20130201 OTC MONOGRAPH FINAL part352 MD Solar Sciences AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 27.5 mg/mL; mg/mL; mg/mL 49358-550_4aa6ccae-4969-4b27-a233-20ac56fda68c 49358-550 HUMAN OTC DRUG Mineral Beauty Balm Broad Spectrum SPF 50 Sunscreen UVA-UVB Suncreen Light/Medium Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part352 MDSolarSciences TITANIUM DIOXIDE; ZINC OXIDE 2.7; 1.3 g/35g; g/35g 49358-551_4aa6ccae-4969-4b27-a233-20ac56fda68c 49358-551 HUMAN OTC DRUG Mineral Beauty Balm Broad Spectrum SPF 50 Sunscreen UVA-UVB Suncreen Medium/Dark Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part352 MDSolarSciences TITANIUM DIOXIDE; ZINC OXIDE 2.7; 1.3 g/35g; g/35g 49358-552_36858578-6325-48cf-b9d5-b9bfad42d4ea 49358-552 HUMAN OTC DRUG Mineral Creme Broad Spectrum SPF 30 Sunscreen UVA-UVB Suncreen Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140301 OTC MONOGRAPH FINAL part352 MDSolarSciences TITANIUM DIOXIDE; ZINC OXIDE 2.7; 1.3 g/35g; g/35g 49358-554_ed5389b7-3bee-456d-a853-dec2bea7aa83 49358-554 HUMAN OTC DRUG Mineral Broad Spectrum SPF 50 Sunscreen UVA-UVB Suncreen Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140301 OTC MONOGRAPH FINAL part352 MDSolarSciences TITANIUM DIOXIDE; ZINC OXIDE 2.7; 1.3 g/35g; g/35g 49363-9901_f12b1c11-8974-4976-a9df-c5d764661401 49363-9901 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Gano Welding Supplies, Inc OXYGEN 99.5 L/100L 49364-110_08d050e8-f5dc-4dca-bbef-833156e28729 49364-110 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20101109 ANDA ANDA065248 Strategic Pharmaceutical Solutions, Inc. DBA VetSource CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 49364-111_08d050e8-f5dc-4dca-bbef-833156e28729 49364-111 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20101109 ANDA ANDA065248 Strategic Pharmaceutical Solutions, Inc. DBA VetSource CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 49371-015_cbdbc8ef-91cc-44d8-a11c-1432d923837c 49371-015 HUMAN OTC DRUG Pier 1 Imports Blueberry Parfait Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-016_1c46a615-7e92-4c1d-af2a-e108ddaced8d 49371-016 HUMAN OTC DRUG Pier 1 Imports Cherry Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-017_ecef821f-08e2-46ba-8b2b-c3babccf0c26 49371-017 HUMAN OTC DRUG Pier 1 Imports Lavender Vanilla Anti-Bacterial Hand Sanitizer Pier 1 Imports Hand Sanitizer LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-018_da3a1bbf-7260-4c23-8902-3cd33536427f 49371-018 HUMAN OTC DRUG Pier 1 Imports Lily blossom Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-019_715ddd48-f14b-4282-992f-b31ed82e418e 49371-019 HUMAN OTC DRUG Pier 1 Imports Melon and Mint Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-020_3d3c09cf-7bf4-4a10-a2c0-b8fc98c834c7 49371-020 HUMAN OTC DRUG Pier 1 Imports Passion Fruit Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-021_6b751edb-e42b-4da2-88fa-c904b130ec72 49371-021 HUMAN OTC DRUG Wild Strawberry Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-022_36ed9405-5b62-45ea-ad2f-82f2d3e0fb7e 49371-022 HUMAN OTC DRUG Peach Mango Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-023_6709c311-85cd-4c38-935e-eb76ad1e6d29 49371-023 HUMAN OTC DRUG Coconut Lime Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-024_9fbf3e68-9a84-4b24-9926-724c9ba4539f 49371-024 HUMAN OTC DRUG Mandarin Orange Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-025_2b032c9b-765a-458f-a383-15a36660d175 49371-025 HUMAN OTC DRUG Pier 1 Imports Crisp Bamboo Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-026_3f1b7dd3-e565-41bd-895e-0f18849f6ac2 49371-026 HUMAN OTC DRUG Pier 1 Imports Ginger Peach Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-027_4361f570-3903-430f-a086-bbf0310e488c 49371-027 HUMAN OTC DRUG Pier 1 Imports Lavender Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-028_a66ee6bb-c3ef-4383-8724-e0fc0329ac21 49371-028 HUMAN OTC DRUG Pier 1 Imports Iced Cookie Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-030_24b3b68e-9e1d-4bee-9c8a-c7a01b4cb642 49371-030 HUMAN OTC DRUG Pier 1 Imports Sugared Plum Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-031_85260ee1-f2be-4671-b1de-f5333b42a686 49371-031 HUMAN OTC DRUG Pier 1 Imports Vanilla Mint Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-032_6985404e-5215-4208-a053-9590e12236b3 49371-032 HUMAN OTC DRUG Healing Water Amber Flower Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100320 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-033_5cdd43ba-b909-4606-b2a0-f87149e84e60 49371-033 HUMAN OTC DRUG Healing Waters Vanilla Orchid Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100320 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-034_2e9aa2df-d3b6-4527-ae44-ee0fe1fddce1 49371-034 HUMAN OTC DRUG Dots Apple Cinnamon Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-035_619e7ed6-491d-4863-a12b-b66f61b2eeb4 49371-035 HUMAN OTC DRUG Dots Asian Spice Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-036_e8be399f-69a5-41eb-987e-531ac530b69d 49371-036 HUMAN OTC DRUG Lavender Vanilla Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-037_2db88a46-707d-4e5d-bd20-c321e98cd9d6 49371-037 HUMAN OTC DRUG Wild Strawberry Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-038_abce3d3b-c12e-4313-9d27-79bc961ff771 49371-038 HUMAN OTC DRUG Love and Beauty Melon and Mint Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-039_54ecb3f0-5b0a-4d51-9cf1-d45aa92faddf 49371-039 HUMAN OTC DRUG Love and Beauty Peach Mango Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-040_b38e4d1d-4194-47ea-be1f-6ddd4bbbf25c 49371-040 HUMAN OTC DRUG Rue 21 Asian Spice Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-041_bee9a57a-7599-43c4-9bc5-34c67ef5ebf3 49371-041 HUMAN OTC DRUG Rue21 Coco Breeze Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-042_7a446ab9-2daf-4180-bacf-3042d6ec70ba 49371-042 HUMAN OTC DRUG Rue21 Island Fruits Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-043_c644b1a4-67b6-43a6-9229-bb08162f0cdf 49371-043 HUMAN OTC DRUG Rue21 Ocean Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g 49371-044_8c686337-2236-4bae-bc4e-d09de3133ee6 49371-044 HUMAN OTC DRUG Aromafields Jasmine Scented Anti-Bacterial Hand Triclosan LOTION TOPICAL 20100620 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. TRICLOSAN .15 g/100g 49371-045_35006f88-a5bc-4633-ab70-9cafa6f41301 49371-045 HUMAN OTC DRUG Aromafields Lavender Scented Anti-Bacterial Hand Triclosan LOTION TOPICAL 20100620 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. TRICLOSAN .15 g/100g 49371-046_0bbf7e17-819b-44e5-9d17-96a9ca3401a7 49371-046 HUMAN OTC DRUG Aromafields Plumeria Scented Anti-Bacterial Hand Triclosan LOTION TOPICAL 20100620 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. TRICLOSAN .15 g/100g 49371-047_83d16199-e5b8-4aa3-abdc-1da530b74238 49371-047 HUMAN OTC DRUG Aromafields Tiger Lily Scented Anti-Bacterial Hand Triclosan LOTION TOPICAL 20100620 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. TRICLOSAN .15 g/100g 49390-100_095640b9-b5fc-4988-bd91-c7b11e9cb0d6 49390-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091201 UNAPPROVED MEDICAL GAS Linweld, Inc. OXYGEN 995 mL/L 49390-300_76f28081-a5b6-4da7-9784-ee6462d709c0 49390-300 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20091201 UNAPPROVED MEDICAL GAS Linweld, Inc NITROGEN 99 mL/L 49401-101_956443f7-d844-4a3b-977a-4deb76925885 49401-101 HUMAN PRESCRIPTION DRUG BENLYSTA belimumab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110310 BLA BLA125370 Human Genome Sciences, Inc. BELIMUMAB 120 mg/1.5mL Decreased B Lymphocyte Activation [PE],B Lymphocyte Stimulator-specific Inhibitor [EPC],B Lymphocyte Stimulator-directed Antibody Interactions [MoA] 49401-102_956443f7-d844-4a3b-977a-4deb76925885 49401-102 HUMAN PRESCRIPTION DRUG BENLYSTA belimumab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110310 BLA BLA125370 Human Genome Sciences, Inc. BELIMUMAB 400 mg/5mL Decreased B Lymphocyte Activation [PE],B Lymphocyte Stimulator-specific Inhibitor [EPC],B Lymphocyte Stimulator-directed Antibody Interactions [MoA] 49401-103_5a637359-dc40-417a-adae-8eca6d7234ec 49401-103 HUMAN PRESCRIPTION DRUG Raxibacumab raxibacumab INJECTION INTRAVENOUS 20121214 BLA BLA125349 Human Genome Sciences, Inc. RAXIBACUMAB 50 mg/mL 49401-104_5a637359-dc40-417a-adae-8eca6d7234ec 49401-104 HUMAN PRESCRIPTION DRUG Raxibacumab raxibacumab INJECTION INTRAVENOUS 20121214 BLA BLA125349 Human Genome Sciences, Inc. RAXIBACUMAB 50 mg/mL 49404-100_a32a4d20-d592-4188-b88d-14029c78faca 49404-100 HUMAN OTC DRUG Dr. Jart Water Fuse Beauty Balm Titanium Dioxide, Octinoxate, Octisalate CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Have and Be Co.,Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3; 2.25; 3.611 mL/50mL; mL/50mL; mL/50mL 49404-101_87dcd67d-9718-437b-83b2-04b9eefe7f28 49404-101 HUMAN OTC DRUG Dr. Jart Premium Beauty Balm Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Have and Be Co.,Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.606; 2.522 mL/40mL; mL/40mL 49404-102_a4a5503c-bad0-4257-9293-28a97ae05454 49404-102 HUMAN OTC DRUG Detox Healing BB Titanium Dioxide, Zinc Oxide, Octinoxate CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 3.195; .98 mL/50mL; mL/50mL; mL/50mL 49404-103_c66055b5-c7ce-49dd-9bbf-4479e5c8fc08 49404-103 HUMAN OTC DRUG Rejuvenating BB Titanium Dioxde, Octinoxate CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE 2; 4.5 mL/50mL; mL/50mL 49404-104_c34b1a27-8a3f-4294-971d-74e52a6bc901 49404-104 HUMAN OTC DRUG AGE-X Platinum BB Titanium Dioxide, Octinoxate CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE 2.1; 1.68 mL/30mL; mL/30mL 49404-105_fb5a1a53-0c1d-428f-93e7-4eea5aa531a3 49404-105 HUMAN OTC DRUG Dr.Jart V7 Beauty Balm Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120730 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 4.176; .576 mL/40mL; mL/40mL 49404-106_edaab6ff-7774-400a-a90f-61e35ee02026 49404-106 HUMAN OTC DRUG Dr.Jart Renewalist BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120730 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 2.704; 1.891 mL/30mL; mL/30mL 49404-107_a7654cd4-95c9-4051-bfd5-5b91d13a119e 49404-107 HUMAN OTC DRUG Dr.Jart Black Label Detox BB Beaty Balm Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.8132; 1.536 mL/40mL; mL/40mL 49404-108_ab5874d0-396f-4790-8583-80367355e919 49404-108 HUMAN OTC DRUG Dr.Jart For Men Active BB Block OCTINOXATE, TITANIUM DIOXIDE, Zinc Oxide CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.5; 2.8975; 1.5435 mL/50mL; mL/50mL; mL/50mL 49404-109_902a4fb3-e3de-4330-8026-d39b79d72a02 49404-109 HUMAN OTC DRUG Dr. Jart Hydrafull Beauty Balm Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE 2; 3.561 g/50mL; g/50mL 49404-110_25631a7f-48b2-456f-8da4-f68e8c531071 49404-110 HUMAN OTC DRUG Dr. Jart Nourishing Beauty Balm Titanium Dioxide, Octinoxate, Zinc Oxide GEL TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 3.195; .96 g/50mL; g/50mL; g/50mL 49404-111_8e27bdc3-a3e4-4863-b569-5d5b90a932b4 49404-111 HUMAN OTC DRUG Dr. Jart Rejuvenating Beauty Balm Titanium Dioxide, Octinoxate LOTION TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE 2; 4.5 mg/50mL; mg/50mL 49404-112_035b6cf1-f7e7-4a76-8084-d6869e48ea5b 49404-112 HUMAN OTC DRUG Dr. Jart Smart BB 01 Titanium Dioxide, Octinoxate, Octisalate, Octocrylene GEL TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 2.1; 1.2; .6; 2.1 g/30mL; g/30mL; g/30mL; g/30mL 49404-113_5fc895d7-36d4-4e6d-9b2e-503a6eb01481 49404-113 HUMAN OTC DRUG Dr. Jart Smart BB 02 Titanium Dioxide, Octinoxate, Octisalate, Octocrylene GEL TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 2.1; 1.2; .6; 2.1 g/30mL; g/30mL; g/30mL; g/30mL 49404-114_10f00859-82dc-4595-b98a-b7c893fbc7d7 49404-114 HUMAN OTC DRUG Dr.Jart CC Essence Balm 01 Light - Medium Titanium Dioxide, OCTINOXATE, Zinc Oxide, OCTISALATE CREAM TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE .48; .192; 1.147; .279 g/12g; g/12g; g/12g; g/12g 49404-115_2623771d-57c0-48aa-ad36-61c36667db87 49404-115 HUMAN OTC DRUG Dr.Jart CC Essence Balm 02 Medium - Deep Titanium Dioxide, OCTINOXATE, Zinc Oxide, OCTISALATE CREAM TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE .48; .192; 1.147; .279 g/12g; g/12g; g/12g; g/12g 49404-116_e3666d2d-50f6-4e6e-85b9-dc66b7116fae 49404-116 HUMAN OTC DRUG Dr. Jart Shimmering Beauty Balm 01 Light - Medium Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.516; 1.152 g/40mL; g/40mL 49404-117_c1224b16-97ca-40ec-8a7a-c796f7e78991 49404-117 HUMAN OTC DRUG Dr. Jart Shimmering Beauty Balm 02 Medium - Deep Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.536; 1.152 g/40mL; g/40mL 49404-118_d35a8da4-e143-41cd-a289-afd298be4cdc 49404-118 HUMAN OTC DRUG Dr.Jart BB Mate Contouring 01 Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20141027 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .24; .695; .0588 mg/6mL; mg/6mL; mg/6mL 49404-119_b718bb37-ca55-4044-8abf-2875a21ecd9a 49404-119 HUMAN OTC DRUG Dr.Jart BB Mate Contouring 02 Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20141027 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .24; .567; .0588 mg/6mL; mg/6mL; mg/6mL 49404-120_4e7ce13c-55bf-4343-aea0-1d365e3ea1f2 49404-120 HUMAN OTC DRUG Dr.Jart BB Mate Contouring 03 Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20141027 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .24; .566; .059 mg/6mL; mg/6mL; mg/6mL 49404-121_40bb741d-c038-44e4-8a4f-feddcaf383d2 49404-121 HUMAN OTC DRUG Dr.Jart Premium Beauty Balm 02 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.606; 2.522 mg/40mL; mg/40mL 49404-200_f41fc12b-0dbf-437b-b100-1af752efbd31 49404-200 HUMAN OTC DRUG Dr. Jart Bounce Beauty Balm 01 Light-medium Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE .6156; .3456 g/12g; g/12g 49404-201_de0e634e-3455-462b-a1b1-7ab244dc87e1 49404-201 HUMAN OTC DRUG Dr. Jart Bounce Beauty Balm 02 Medium-Deep Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE .6156; .3456 g/12g; g/12g 49404-202_5743dce9-0981-47b8-be48-2a990dd2d0fe 49404-202 HUMAN OTC DRUG Dr. Jart DIS-A-PORE Beauty Balm Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2; 4.73; .49 g/50g; g/50g; g/50g 49404-203_19b34c42-7539-4346-a28a-36fbfbc516a2 49404-203 HUMAN OTC DRUG Dr. Jart RADIANCE Beauty Balm Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.6; 3.78; .392 g/40g; g/40g; g/40g 49404-204_3cc7e4f3-5cc8-4da6-af56-229361164c22 49404-204 HUMAN OTC DRUG Dr.Jart Prescriptment All That Lift and Firm Glycerin PATCH TOPICAL 20140716 OTC MONOGRAPH FINAL part347 Have and Be Co., Ltd. GLYCERIN 35 1/18g 49406-003_e85fc8bc-f7ae-4ac6-bc0a-ec6a0917e0f5 49406-003 HUMAN OTC DRUG Formula 3 TOLNAFTATE SOLUTION TOPICAL 20121030 OTC MONOGRAPH FINAL part333C The Tetra Corporation TOLNAFTATE 10 mg/mL 49406-004_33d4072d-bbb3-465a-a0bc-10b7cfe08961 49406-004 HUMAN OTC DRUG FungiFoam TOLNAFTATE AEROSOL, FOAM TOPICAL 20121031 OTC MONOGRAPH FINAL part333C The Tetra Corporation TOLNAFTATE 10 mg/mL 49411-050_2238c70f-b0b5-4755-896b-45b28777b217 49411-050 HUMAN PRESCRIPTION DRUG AMICAR Aminocaproic Acid TABLET ORAL 20120411 NDA NDA015197 Clover Pharmaceuticals Corp. AMINOCAPROIC ACID 500 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 49411-051_2238c70f-b0b5-4755-896b-45b28777b217 49411-051 HUMAN PRESCRIPTION DRUG AMICAR Aminocaproic Acid TABLET ORAL 20120411 NDA NDA015197 Clover Pharmaceuticals Corp. AMINOCAPROIC ACID 1000 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 49411-052_2238c70f-b0b5-4755-896b-45b28777b217 49411-052 HUMAN PRESCRIPTION DRUG AMICAR Aminocaproic Acid SOLUTION ORAL 20120411 NDA NDA015230 Clover Pharmaceuticals Corp. AMINOCAPROIC ACID .25 g/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 49415-0001_c4886d68-3474-4808-a84b-e861f36c466b 49415-0001 HUMAN OTC DRUG HGH Complex Arnica Montana, Carduus Marianus, Hepar Suis, Korean Ginseng, Phosphoricum Acidum, Pituitaria Glandula Suis, SPRAY ORAL 20131230 UNAPPROVED HOMEOPATHIC Maximum Results Solution, Inc. ARNICA MONTANA; ASIAN GINSENG; PHOSPHORIC ACID; PORK LIVER; SILYBUM MARIANUM SEED; SUS SCROFA PITUITARY GLAND 3; 1; 3; 6; 1; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49415-0002_4446b99e-1efe-43b2-a710-c475d62800e4 49415-0002 HUMAN OTC DRUG Weight Loss Solution Amino Acids, Apis Mellifica, Arnica Montana, Fucus Vesiculosus, Gambogia, Hepar Suis, Phosphoricum Acidum, Pituitaria Glandula Suis, Thuja Occidentalis, Thyroidinum Suis, SPRAY ORAL 20131025 UNAPPROVED HOMEOPATHIC Maximum Results Solution, Inc. AMINO ACIDS; APIS MELLIFERA; ARNICA MONTANA; FUCUS VESICULOSUS; GAMBOGE; PHOSPHORIC ACID; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; THUJA OCCIDENTALIS LEAF 6; 4; 3; 3; 3; 3; 6; 24; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 49430-007_25758187-f375-4bf7-b446-91e13593244e 49430-007 HUMAN OTC DRUG Puroxcin LIDOCAINE HYDROCHLORIDE, MENTHOL LIQUID TOPICAL 20140710 OTC MONOGRAPH NOT FINAL part348 Pharmaceutics Corporation LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g 49430-014_5c7c5461-e72f-47c7-9ee0-5349ef30ce82 49430-014 HUMAN OTC DRUG Aleveer Patch Menthol, Capsaicin PATCH TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part348 Pharmaceutics Corporation CAPSAICIN; MENTHOL .0375; 5 g/100g; g/100g 49430-017_6dd0223e-b805-4001-8150-62f26ae9cece 49430-017 HUMAN PRESCRIPTION DRUG eLenza Patch Lidocaine Hydrochloride PATCH TOPICAL 20131001 UNAPPROVED DRUG OTHER Pharmaceutics Corporation LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 49430-046_5eda4055-1040-4d92-a811-72e7f8797e2b 49430-046 HUMAN PRESCRIPTION DRUG Lidodextrapine Lidocaine, Menthol PATCH TOPICAL 20140828 UNAPPROVED DRUG OTHER Pharmaceutics Corporation LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 49430-047_bcdbfafc-0ba8-48d0-ae08-1eac2c2964c8 49430-047 HUMAN PRESCRIPTION DRUG Reciphexamine Lidocaine, Menthol PATCH TOPICAL 20140828 UNAPPROVED DRUG OTHER Pharmaceutics Corporation LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 49430-048_c413298e-a664-4bc3-8942-9fdacb58e7e5 49430-048 HUMAN PRESCRIPTION DRUG Qroxin Patch Menthol, Capsaicin PATCH TOPICAL 20140828 UNAPPROVED DRUG OTHER Pharmaceutics Corporation CAPSAICIN; MENTHOL .0375; 5 g/100g; g/100g 49436-290_d21e1381-d9f9-495e-9037-23e1443483d7 49436-290 HUMAN OTC DRUG PurTect PETROLATUM, CHLOROXYLENOL OINTMENT TOPICAL 20120501 OTC MONOGRAPH FINAL part346 PurKlenz Formulations Inc. CHLOROXYLENOL; PETROLATUM .8; 63 mL/100mL; mL/100mL 49436-291_3cc76e43-c5ba-40fb-ba6d-9597888f104e 49436-291 HUMAN OTC DRUG PurKlenz CHLOROXYLENOL LIQUID TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part333E PurKlenz Formulations Inc. CHLOROXYLENOL 2.949 g/100mL 49436-292_6a7006c4-222a-4def-9072-15e96e0c718c 49436-292 HUMAN OTC DRUG PurSan CHLOROXYLENOL LOTION TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333E PurKlenz Formulations Inc. CHLOROXYLENOL .08 mg/100mL 49449-100_c3be950b-28cf-47c2-9570-ebd46e43b1ba 49449-100 HUMAN OTC DRUG TCX Skincare Colloidal Oatmeal CREAM TOPICAL 20120517 OTC MONOGRAPH FINAL part347 Theraceutix, LLC OATMEAL 2 mL/100mL 49467-104_f766aeb1-5874-44b3-b47c-5ada3f082f58 49467-104 HUMAN OTC DRUG NAUS-EASE MECLIZINE HYDROCHLORIDE FILM, SOLUBLE ORAL 20120416 OTC MONOGRAPH FINAL part336 Sunascen Therapeutics LLC MECLIZINE HYDROCHLORIDE 25 mg/1 49467-124_f1a5609e-ec67-47be-8108-8a6ab0b382ce 49467-124 HUMAN OTC DRUG NAUS-EASE MECLIZINE HYDROCHLORIDE TABLET ORAL 20120416 ANDA ANDA040659 Sunascen Therapeutics LLC MECLIZINE HYDROCHLORIDE 25 mg/1 49471-001_2fbcc40c-f102-4abe-bce5-a93de95874fe 49471-001 HUMAN PRESCRIPTION DRUG PRE-PEN benzylpenicilloyl polylysine INJECTION INTRADERMAL; SUBCUTANEOUS 19740725 NDA NDA050114 AllerQuest LLC BENZYLPENICILLOYL POLYLYSINE 60 umol/.25mL 49483-003_ade947ae-a71d-4b8e-9d51-c905ff9bd269 49483-003 HUMAN OTC DRUG STIMULANT LAXATIVE BISACODYL TABLET, DELAYED RELEASE ORAL 20140401 OTC MONOGRAPH NOT FINAL part334 TIME CAP LABORATORIES, INC. BISACODYL 5 mg/1 49483-011_44323eb2-3218-42a3-92a3-35569c11d8f8 49483-011 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, COATED ORAL 20140402 OTC MONOGRAPH NOT FINAL part343 TIME CAP LABS INC ASPIRIN 325 mg/1 49483-016_ad109144-ae93-4679-9b66-927a1a89cea2 49483-016 HUMAN OTC DRUG PSEUDO-TIME PSEUDOEPHEDRINE HCL TABLET, COATED ORAL 20120501 OTC MONOGRAPH FINAL part341 TIME CAP LABORATORIES, INC. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 49483-046_8da3d6dc-fb6e-48f5-bacb-5ab1c5ec9e30 49483-046 HUMAN OTC DRUG NEW CORRECT BISACODYL TABLET, DELAYED RELEASE ORAL 20080806 OTC MONOGRAPH NOT FINAL part334 Time-Cap Labs, Inc BISACODYL 5 mg/1 49483-052_b1c1f6da-f87a-4e89-b9ad-da6a79573184 49483-052 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, DELAYED RELEASE ORAL 20120508 OTC MONOGRAPH FINAL part343 TIME CAP LABORATORIES INC. ASPIRIN 325 mg/1 49483-054_15e2f689-ed8f-4cdd-b00e-cd0358b2cfda 49483-054 HUMAN OTC DRUG MINIPRIN ASPIRIN TABLET, COATED ORAL 20120507 OTC MONOGRAPH FINAL part343 TIME CAP LABORATORIES, INC ASPIRIN 81 mg/1 49483-061_dcd4537b-a1f5-4081-8aa8-7c168135fb05 49483-061 HUMAN OTC DRUG ALLER-G-TIME DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120501 OTC MONOGRAPH FINAL part341 TIME CAP LABORATORIES, INC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49483-080_790c6fca-0100-4f6a-83ef-729befb7feef 49483-080 HUMAN OTC DRUG SENNA TIME SENNOSIDES TABLET, COATED ORAL 20120514 OTC MONOGRAPH NOT FINAL part334 TIME CAP LABORATORIES, INC SENNOSIDES A AND B 8.6 mg/1 49483-081_52a597bd-4088-4688-8b95-f4c28ebe7ba4 49483-081 HUMAN OTC DRUG SENNA TIME S DOCUSATE SODIUM-SENNOSIDES TABLET, FILM COATED ORAL 20120514 OTC MONOGRAPH NOT FINAL part334 TIME CAP LABORATORIES, INC DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; min/1 49483-097_f3dcbb41-3272-4f01-b244-96245eab31bb 49483-097 HUMAN OTC DRUG SENNOSIDES AND DOCUSATE SODIUM SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED ORAL 20100101 OTC MONOGRAPH NOT FINAL part334 TIME CAP LABORATORIES, INC DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 49483-221_0985311e-10c0-43fe-bb8c-e720c325bb69 49483-221 HUMAN PRESCRIPTION DRUG NITRO-TIME NITROGLYCERIN CAPSULE ORAL 20140619 UNAPPROVED DRUG OTHER TIME CAP LABORATORIES, INC NITROGLYCERIN 2.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 49483-222_0985311e-10c0-43fe-bb8c-e720c325bb69 49483-222 HUMAN PRESCRIPTION DRUG NITRO-TIME NITROGLYCERIN CAPSULE ORAL 20140619 UNAPPROVED DRUG OTHER TIME CAP LABORATORIES, INC NITROGLYCERIN 6.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 49483-223_0985311e-10c0-43fe-bb8c-e720c325bb69 49483-223 HUMAN PRESCRIPTION DRUG NITRO-TIME NITROGLYCERIN CAPSULE ORAL 20140619 UNAPPROVED DRUG OTHER TIME CAP LABORATORIES, INC NITROGLYCERIN 9 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 49483-234_2709c2f7-6835-4f5b-b3ef-77aaec7f2025 49483-234 HUMAN OTC DRUG PSEUDO TIME PE PHENYLEPHRINE HCHLORIDE TABLET, FILM COATED ORAL 20120514 OTC MONOGRAPH NOT FINAL part341 TIME CAP LABORATORIES, INC. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 49483-242_ed77fca7-5e50-416e-8ef6-9d4fe08ccb61 49483-242 HUMAN OTC DRUG Allergy Time Chlorpheniramine Maleate TABLET ORAL 20110208 OTC MONOGRAPH FINAL part341 Time Cap Labs Inc CHLORPHENIRAMINE MALEATE 4 mg/1 49483-252_697a6cd9-ba32-4069-a59a-6b6ae8c76a38 49483-252 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20110712 OTC MONOGRAPH NOT FINAL part343 TIME CAP LABS INC ACETAMINOPHEN 500 mg/1 49483-272_fd65b9c5-9d9d-4759-8b7c-9e967cab911b 49483-272 HUMAN OTC DRUG MUCOSA GUAIFENESIN TABLET ORAL 20120416 OTC MONOGRAPH FINAL part341 TIME CAP LABORATORIES, INC GUAIFENESIN 400 mg/1 49483-280_6b0db81c-fba0-4305-a34d-f849af1f575a 49483-280 HUMAN OTC DRUG MUCOSA DM GUAIFENESIN DEXTROMETHORPHAN TABLET ORAL 20120417 OTC MONOGRAPH FINAL part341 TIME CAP LABORATORIES, INC. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 49483-328_e449eb3e-6363-4f5d-be12-d2982ca4739d 49483-328 HUMAN OTC DRUG Low Dose Aspirin Enteric Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 20100811 OTC MONOGRAPH FINAL part343 Time-Cap Labs, Inc ASPIRIN 81 mg/1 49483-329_42e5cb1a-5f14-4c2e-ad9e-6478c07f99de 49483-329 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20100301 OTC MONOGRAPH FINAL part341 Time-Cap Labs, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49483-330_c9db41ce-82b3-45c6-bcbc-0466d5169819 49483-330 HUMAN OTC DRUG Low Dose Miniprin Enteric Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 20100811 OTC MONOGRAPH FINAL part343 Time-Cap Labs, Inc ASPIRIN 81 mg/1 49483-331_6c52b0ef-7098-48c2-a9fd-c998c06b1272 49483-331 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength Aspirin TABLET, DELAYED RELEASE ORAL 20110104 OTC MONOGRAPH FINAL part343 Time-Cap Labs, Inc ASPIRIN 325 mg/3251 49483-333_83fa6fe0-38f3-4538-9334-cfb15f77fe56 49483-333 HUMAN OTC DRUG Motion-Time Chewable Meclizine HCl TABLET, CHEWABLE ORAL 20100809 OTC MONOGRAPH FINAL part336 Time-Cap Labs, Inc MECLIZINE HYDROCHLORIDE 25 mg/251 49483-334_7cbe5b15-f6f6-49a3-ba9a-cf4ba9389113 49483-334 HUMAN OTC DRUG aspirin low dose chewable aspirin TABLET, CHEWABLE ORAL 20100716 OTC MONOGRAPH NOT FINAL part343 Time-Cap Labs, Inc ASPIRIN 81 mg/1 49483-340_ca914f43-ad7a-4538-a264-12d56aac5fb1 49483-340 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20111215 OTC MONOGRAPH NOT FINAL part343 TIME CAP LABS INC ACETAMINOPHEN 325 mg/1 49483-341_af176493-5b64-4dcc-bd1a-e01517146737 49483-341 HUMAN OTC DRUG ACETAMINOPHEN EXTRA STRENGTH ACETAMINOPHEN TABLET, FILM COATED ORAL 20110718 OTC MONOGRAPH NOT FINAL part343 TIME CAP LABS INC ACETAMINOPHEN 500 mg/1 49483-342_308c3978-c956-4b2e-9275-21791ed922dd 49483-342 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET, FILM COATED ORAL 20120501 OTC MONOGRAPH NOT FINAL part343 TIME CAP LABORATORIES, INC ACETAMINOPHEN 500 mg/1 49483-343_36c720dd-a758-4033-b925-24b8b6b7b7e1 49483-343 HUMAN OTC DRUG Alert Caffeine TABLET, FILM COATED ORAL 20111130 OTC MONOGRAPH FINAL part340 Time Cap Labs, Inc CAFFEINE 200 mg/1 49483-347_23c705a0-380c-4de8-b00d-b704cc023c3c 49483-347 HUMAN OTC DRUG Comfort-Time Acetaminophen, Caffeine, and Pyrilamine Maleate TABLET, FILM COATED ORAL 20111130 OTC MONOGRAPH NOT FINAL part343 Time Cap Labs, Inc ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 49483-349_9b82ef2e-c898-4a71-be2d-ee22806bca24 49483-349 HUMAN OTC DRUG Aspirin Delayed Release Aspirin TABLET, DELAYED RELEASE ORAL 20101223 OTC MONOGRAPH FINAL part343 Time-Cap Labs, Inc ASPIRIN 81 mg/811 49483-352_1a1fa4eb-5672-4f61-8e95-2c5f00d08f69 49483-352 HUMAN OTC DRUG DIMENHYDRINATE DIMENHYDRINATE TABLET, FILM COATED ORAL 20110128 OTC MONOGRAPH FINAL part336 Time Cap Labs, Inc DIMENHYDRINATE 50 mg/1 49483-356_92884990-789c-40b6-a937-2b3da8c4a58f 49483-356 HUMAN OTC DRUG TIME-GESIC ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20121218 OTC MONOGRAPH FINAL part341 Time-Cap Labs, Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 325; 12.5 mg/1; mg/1 49483-370_2c74d043-170c-4d9c-bbec-d8eb8d470ac3 49483-370 HUMAN OTC DRUG EXTRA PAIN RELIEF ACETAMINOPHEN, ASPIRIN AND CAFFEINE TABLET, FILM COATED ORAL 20131101 OTC MONOGRAPH NOT FINAL part343 TIME CAP LABS ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 49483-381_b92872cb-0e33-47eb-b61f-cbeff1958a81 49483-381 HUMAN OTC DRUG Low Dose Aspirin Enteric Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 20100810 OTC MONOGRAPH FINAL part343 Time-Cap Labs, Inc ASPIRIN 81 mg/1 49483-382_adca4a69-3258-4604-955e-a8e3d46d102b 49483-382 HUMAN OTC DRUG ASPIRIN EXTRA STRENGTH Aspirin TABLET, COATED ORAL 20130211 OTC MONOGRAPH FINAL part343 Time-Cap Labs, Inc ASPIRIN 500 mg/5001 49483-387_0a64066d-1a04-4fc7-afa2-cdd4a56475aa 49483-387 HUMAN OTC DRUG aspirin low dose enteric coated aspirin TABLET, COATED ORAL 20100628 OTC MONOGRAPH FINAL part343 Time-Cap Labs, Inc ASPIRIN 81 mg/1 49483-390_c94b1a7b-bd1c-4334-91f3-b43cfeb15111 49483-390 HUMAN OTC DRUG aspirin low dose enteric coated aspirin TABLET ORAL 20100716 OTC MONOGRAPH FINAL part343 Time-Cap Labs, Inc ASPIRIN 81 mg/1 49496-001_add0c5b7-1162-45bd-a79d-206db4e0ec22 49496-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100827 NDA NDA205712 American Compressed Gases Inc. OXYGEN 992 mL/L 49502-420_634a0b91-14da-485d-b5a7-2f6de7f5b18b 49502-420 HUMAN PRESCRIPTION DRUG Eldepryl selegiline hydrochloride CAPSULE ORAL 20120702 NDA NDA020647 Mylan Specialty SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] 49502-500_0822d6dd-5141-4e46-bec0-621ef0162ccb 49502-500 HUMAN PRESCRIPTION DRUG EPIPEN epinephrine INJECTION INTRAMUSCULAR 19871222 NDA NDA019430 Mylan Specialty L.P. EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 49502-501_0822d6dd-5141-4e46-bec0-621ef0162ccb 49502-501 HUMAN PRESCRIPTION DRUG EPIPEN JR epinephrine INJECTION INTRAMUSCULAR 19871222 NDA NDA019430 Mylan Specialty L.P. EPINEPHRINE .15 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 49502-605_53fab15e-1887-48b9-81d8-f13fc89cb8e8 49502-605 HUMAN PRESCRIPTION DRUG Perforomist formoterol fumarate dihydrate SOLUTION RESPIRATORY (INHALATION) 20071001 NDA NDA022007 Mylan Specialty L.P. FORMOTEROL FUMARATE 20 ug/2mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 49502-672_badf0544-34cb-4277-9196-f5991a5adfa0 49502-672 HUMAN PRESCRIPTION DRUG DuoNeb ipratropium bromide and albuterol sulfate SOLUTION RESPIRATORY (INHALATION) 20110215 NDA NDA020950 Mylan Specialty ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 2.5; .5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 49502-900_f2b5f3ad-80da-43f8-81a7-f03a266c981f 49502-900 HUMAN PRESCRIPTION DRUG EMSAM selegiline PATCH TRANSDERMAL 20060227 NDA NDA021336 Mylan Specialty SELEGILINE 6 mg/24h Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] 49502-901_f2b5f3ad-80da-43f8-81a7-f03a266c981f 49502-901 HUMAN PRESCRIPTION DRUG EMSAM selegiline PATCH TRANSDERMAL 20060227 NDA NDA021336 Mylan Specialty SELEGILINE 9 mg/24h Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] 49502-902_f2b5f3ad-80da-43f8-81a7-f03a266c981f 49502-902 HUMAN PRESCRIPTION DRUG EMSAM selegiline PATCH TRANSDERMAL 20060227 NDA NDA021336 Mylan Specialty SELEGILINE 12 mg/24h Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] 49507-001_c70a64ca-9366-45b4-8665-4142a9ac00d6 49507-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19770101 NDA NDA206023 Hagan, Logan Welding Supply Inc OXYGEN 995 mL/L 49514-075_f37ccdca-151e-4700-9c08-7d379cf02102 49514-075 HUMAN OTC DRUG Staples Instant Hand Sanitizer Alcohol GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Staples ALCOHOL 62 mL/100mL 49514-076_06cec0fe-2b11-47b6-beb5-38cb9ae9da68 49514-076 HUMAN OTC DRUG Staples Instant Hand Sanitizer Alcohol GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Staples ALCOHOL 62 mL/100mL 49514-253_a685441d-633f-43f4-89ee-e6ea4d4baf70 49514-253 HUMAN OTC DRUG Antiseptic Hand Sanitizer ALCOHOL SPRAY TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Staples the Office Superstore, LLC ALCOHOL 62 mL/100mL 49517-0001_67c282fa-4c45-42f5-80df-be34cac4f76b 49517-0001 HUMAN OTC DRUG Sayuki Broad Spectrum SPF 30 Anti-Aging Daily Moisturizer Sunscreen AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20120419 OTC MONOGRAPH FINAL part352 Sayuki Custom Cosmetics AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL 49520-101_3985a28f-9688-405e-ac32-602c06f45d9c 49520-101 HUMAN OTC DRUG OBLITERATE BENZOYL PEROXIDE LOTION TOPICAL 20120424 OTC MONOGRAPH FINAL part333D mybody BENZOYL PEROXIDE 5 g/100mL 49520-102_e3393b63-1dbc-4c50-b114-da74582319f5 49520-102 HUMAN OTC DRUG myHELPER BENZOYL PEROXIDE CREAM TOPICAL 20120424 OTC MONOGRAPH FINAL part333D mybody BENZOYL PEROXIDE 5 g/100mL 49520-103_f646e74c-7e69-4992-b8d2-0e9661930c82 49520-103 HUMAN OTC DRUG LET ME CLARIFY SALICYLIC ACID GEL TOPICAL 20120924 OTC MONOGRAPH FINAL part333D mybody SALICYLIC ACID 2 g/100mL 49520-104_75ca949f-d649-4a76-8543-58c5e94daa0a 49520-104 HUMAN OTC DRUG TAKE CONTROL CALMING CLEANSER SALICYLIC ACID GEL TOPICAL 20120927 OTC MONOGRAPH FINAL part333D mybody SALICYLIC ACID 2 g/100mL 49520-201_f4775a0b-f209-4591-9d3b-c84c95d6be5c 49520-201 HUMAN OTC DRUG LIGHT THE WAY HYDROQUINONE LOTION TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part358A mybody HYDROQUINONE 2 g/100mL 49520-301_9e7a0fcb-b887-45d1-9644-dd51021c2ea3 49520-301 HUMAN OTC DRUG PROTECT AND SERVE TINTED SUN SHIELD SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE LOTION TOPICAL 20120923 OTC MONOGRAPH NOT FINAL part352 mybody TITANIUM DIOXIDE; ZINC OXIDE 11; 4 g/100mL; g/100mL 49520-501_32bcb76e-21f4-4c81-9604-225e549314a7 49520-501 HUMAN OTC DRUG ERASE IT KIT SALICYLIC ACID, TITANIUM DIOXIDE, ZINC OXIDE KIT 20140510 OTC MONOGRAPH FINAL part333D mybody 49520-502_10847989-96c6-427a-82d3-1ac9121c4beb 49520-502 HUMAN OTC DRUG CALM IT DOWN KIT TITANIUM DIOXIDE, ZINC OXIDE KIT 20140510 OTC MONOGRAPH FINAL part352 mybody 49520-503_c1930042-d8a9-4265-bdce-7cbdd3ea4e26 49520-503 HUMAN OTC DRUG REVERSE IT KIT TITANIUM DIOXIDE, ZINC OXIDE KIT 20140510 OTC MONOGRAPH FINAL part352 mybody 49523-501_f416a05d-3253-49de-9688-4b652315cae5 49523-501 HUMAN OTC DRUG Baczol Expectorant GUAIFENESIN and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20130204 OTC MONOGRAPH FINAL part341 Lex Inc GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 200; 5 mg/5mL; mg/5mL 49523-505_25259b06-cfdb-4497-8a12-a27a0a0f65dd 49523-505 HUMAN OTC DRUG Baczol Cold Medicine ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, and CHLORPHENIRAMINE MALEATE LIQUID ORAL 20130204 OTC MONOGRAPH FINAL part341 Lex Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 250; 4; 10; 10 mg/5mL; mg/5mL; mg/5mL; mg/5mL 49527-001_5eb8ad12-afba-474e-95b1-f9b3bcfe8d76 49527-001 HUMAN OTC DRUG CITY STICK SPF 15 TITANIUM DIOXIDE STICK TOPICAL 19990501 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC TITANIUM DIOXIDE 4 g/100g 49527-002_30758c13-7195-4d93-840c-563fc8577a1a 49527-002 HUMAN OTC DRUG ALMOST MAKEUP SPF 15 TITANIUM DIOXIDE LIQUID TOPICAL 19980102 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC TITANIUM DIOXIDE 45 mL/100mL 49527-003_4d21b548-1986-4bc2-bfbe-c66cae33e9b8 49527-003 HUMAN OTC DRUG CLINIQUE SKIN SUPPLIES FOR MEN AGE DEFENSE HYDRATOR SPF 15 octinoxate, octisalate, avobenzone LOTION TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC AVOBENZONE; OCTINOXATE; OCTISALATE 2; 7.5; 5 mL/100mL; mL/100mL; mL/100mL 49527-005_651ed07d-d801-458b-bb84-3ca903a55303 49527-005 HUMAN OTC DRUG REDNESS SOLUTIONS MAKEUP SPF 15 WITH PROBIOTIC TECHNOLOGY OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 5.9; 2.9; 3.7 mL/100mL; mL/100mL; mL/100mL 49527-006_64471e3b-3e02-4085-b456-7f3a76da27df 49527-006 HUMAN OTC DRUG CLINIQUE CLARIFYING MAKEUP SALICYLIC ACID POWDER TOPICAL 20101001 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC SALICYLIC ACID .5 g/100g 49527-007_bdbcc35e-1e60-4bf4-818e-c44dd90e841c 49527-007 HUMAN OTC DRUG MOISTURE SURGE TINTED MOISTURIZER SPF 15 TITANIUM DIOXIDE, OCTISALATE, OCTINOXATE LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 2.8; 5; 6.8 mL/100mL; mL/100mL; mL/100mL 49527-008_ff0d1114-24c2-4367-a60d-b1e144649925 49527-008 HUMAN OTC DRUG DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABS INC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 2; 5.2 mL/100mL; mL/100mL; mL/100mL 49527-009_c6e53627-bd4a-4f91-8fdc-594b686f07c8 49527-009 HUMAN OTC DRUG REPAIRWEAR LIFT SPF 15 FIRMING DAY COMBO TO OILY SKIN OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; TITANIUM DIOXIDE 7.5; 1.4 mL/100mL; mL/100mL 49527-010_57a20355-aa90-462f-b51e-68616a1a555d 49527-010 HUMAN OTC DRUG CONTINUOUS COVERAGE MAKEUP SPF 15 TITANIUM DIOXIDE CREAM TOPICAL 19920101 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC TITANIUM DIOXIDE 2 mL/100mL 49527-011_5a4c19e1-4570-4b11-abad-36b19cd16c35 49527-011 HUMAN OTC DRUG REPAIRWEAR LASERFOCUS ALL SMOOTH MAKEUP SPF 15 TITANIUM DIOXIDE, OCTOCRYLENE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTOCRYLENE; TITANIUM DIOXIDE 2; 2.9 mL/100mL; mL/100mL 49527-013_852f2307-d92a-4149-acb8-b09fc712490f 49527-013 HUMAN OTC DRUG EVEN BETTER DARK SPOT CORRECTING BROAD SPECTRUM SPF 15 AVOBENZONE, HOMOSALATE, and OCTISALATE CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC AVOBENZONE; HOMOSALATE; OCTISALATE .03; .03; .05 g/mL; g/mL; g/mL 49527-014_8efb261e-c071-4029-863e-b60335b75899 49527-014 HUMAN OTC DRUG CLINIQUE REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY COMBO OILY OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 3.5; 1.7 mL/100mL; mL/100mL; mL/100mL 49527-015_b0611de3-4a29-4f8c-ae39-d9a383bb15df 49527-015 HUMAN OTC DRUG CITY BASE COMPACT FOUNDATION SPF 15 TITANIUM DIOXIDE PASTE TOPICAL 19981001 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE 5.8 g/100g 49527-017_7972ff02-09c1-4863-9584-ba736f84a978 49527-017 HUMAN OTC DRUG REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 3.5; 1.7 mL/100mL; mL/100mL; mL/100mL 49527-018_92d5f660-b3ce-4123-bd39-c763f59311cd 49527-018 HUMAN OTC DRUG EVEN BETTER COMPACT MAKEUP BROAD SPECTRUM SPF15 TITANIUM DIOXIDE CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE 3.8 g/100g 49527-022_f7640d95-e749-44c8-b826-5543f51414f4 49527-022 HUMAN OTC DRUG REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION OILY OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .078; .0364; .0176 g/mL; g/mL; g/mL 49527-025_b358fe4d-5e3d-4ab1-bebf-f13d4bd891e0 49527-025 HUMAN OTC DRUG EVEN BETTER MAKEUP BROAD SPECTRUM SPF 15 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .06962; .0412; .033 g/mL; g/mL; g/mL 49527-027_d3e7b8b6-a77a-4249-9820-306e70e8fffa 49527-027 HUMAN OTC DRUG EVEN BETTER SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM SPF 20 AVOBENZONE, OCTISALATE, and OCTOCRYLENE CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; OCTISALATE; OCTOCRYLENE .0303; .0505; .2727 g/mL; g/mL; g/mL 49527-028_bcbeaf06-aeb0-49b3-8127-2e93776eca9a 49527-028 HUMAN OTC DRUG MOISTURE SURGE CC BROAD SPECTRUM SPF 30 HYDRATING COLOUR CORRECTOR OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE .08175; .0555; .5772; .0355 g/mL; g/mL; g/mL; g/mL 49527-030_975f3b26-3ebb-4615-8407-9752166040d8 49527-030 HUMAN OTC DRUG AGE DEFENSE BB BROAD SPECTRUM SPF 30 ALL SKIN TYPES OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE .084375; .0495; .039375; .02475 g/100mL; g/100mL; g/100mL; g/100mL 49527-034_0eaa9753-0cc1-4a16-9c93-4242086acbfe 49527-034 HUMAN OTC DRUG SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25 VERY DRY TO DRY OCTISALATE, OXYBENZONE, and AVOBENZONE CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; OCTISALATE; OXYBENZONE .0305; .0508; .0508 g/mL; g/mL; g/mL 49527-035_f28af51c-2628-45c9-b1c4-68341157bd53 49527-035 HUMAN OTC DRUG CLINIQUE SKIN SUPPLIES FOR MEN AGE DEFENSE HYDRATOR BROAD SPECTRUM SPF 15 AVOBENZONE, OCTINOXATE, and OCTISALATE LIQUID TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; OCTINOXATE; OCTISALATE .0203; .076; .0507 g/mL; g/mL; g/mL 49527-036_1d09711f-7990-4c85-8f75-82ff33e34aaa 49527-036 HUMAN OTC DRUG SUPERDEFENSE AGE DEFENSE BROAD SPECTRUM SPF 20 TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE; ZINC OXIDE .060217; .040861 g/100mL; g/100mL 49527-037_9845e0c1-55a0-4c30-83e7-35f5fd3c4094 49527-037 HUMAN OTC DRUG SUPERDEFENSE DAILY DEFENSE MOISTURIZER BROAD SPECTRUM SPF20 (COMBINATION OILY - OILY) AVOBENZONE and OCTISALATE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; OCTISALATE .03; .05 g/mL; g/mL 49527-039_4a3b55c9-4e14-45a6-ba1f-fe327a9f873d 49527-039 HUMAN OTC DRUG SUPERDEFENSE DAILY DEFENSE MOISTURIZER BROAD SPECTRUM SPF20 (VERY DRY - DRY COMB) AVOBENZONE and OCTISALATE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; OCTISALATE .03; .05 g/mL; g/mL 49527-040_89519e46-d9ca-47ba-b53f-6692d53d59ba 49527-040 HUMAN OTC DRUG CLINIQUE MOISTURE SURGE CC COMPACT HYDRATING COLOUR CORRECTOR BROAD SPECTRUM SPF 25 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; TITANIUM DIOXIDE 5.5; 4.7 g/100g; g/100g 49527-041_a317d9aa-c479-4f2b-b15f-64eb5f33f3af 49527-041 HUMAN OTC DRUG CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN HOMOSALATE, OCTISALATE, and AVOBENZONE STICK TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; HOMOSALATE; OCTISALATE 3; 5; 5 g/100g; g/100g; g/100g 49527-044_d75e3178-48a1-4490-b2a5-70dced727793 49527-044 HUMAN OTC DRUG ACNE BB BROAD SPECTRUM SPF 40 OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE CREAM TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .08175; .0218; .01744 g/100mL; g/100mL; g/100mL 49527-045_9e8d729b-4e14-4eac-8dbe-f0cf7d91de36 49527-045 HUMAN OTC DRUG ACNE CLEANSING SALICYLIC ACID GEL TOPICAL 20141001 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC. SALICYLIC ACID .02158 g/100mL 49527-112_2cfb7096-0a73-4e39-838b-8024d1b2926f 49527-112 HUMAN OTC DRUG CLINIQUE EVEN BETTER SKIN TONE CORRECTING BROAD SPECTRUM SPF 20 OCTISALATE, AVOBENZONE, and OCTOCRYLENE LOTION TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 2.7 mL/100mL; mL/100mL; mL/100mL 49527-571_a9d2ee62-41fe-45b6-a93e-e00b93c818a6 49527-571 HUMAN OTC DRUG CLINIQUE ANTIPERSPIRANT DEODORANT ROLL-ON ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 19921201 OTC MONOGRAPH FINAL part350 CLINIQUE LABORATORIES INC ALUMINUM CHLOROHYDRATE 70 mL/100mL 49527-706_f11115d4-0d4f-49b6-a44b-ea4c8d022b78 49527-706 HUMAN OTC DRUG SKIN SUPPLIES FOR MEN ANTIPERSPIRANT ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY CREAM TOPICAL 19840401 OTC MONOGRAPH FINAL part350 CLINIQUE LABORATORIES INC. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.6 g/100g 49527-707_df1d5fe1-1708-49e2-a9cd-5a473c822202 49527-707 HUMAN OTC DRUG SUPER DEFENSE SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 DRY COMBINATION OXYBENZONE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC AVOBENZONE; OCTISALATE; OXYBENZONE 3; 5; 5 mL/100mL; mL/100mL; mL/100mL 49527-708_169e5628-2a40-429c-9bf8-cf24ce3fb9eb 49527-708 HUMAN OTC DRUG SUPER DEFENSE SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 VERY DRY SKIN OXYBENZONE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC AVOBENZONE; OCTISALATE; OXYBENZONE 3; 5; 5 mL/100mL; mL/100mL; mL/100mL 49527-709_1699bc81-2bf7-4cdb-a19e-708dfa2f32d3 49527-709 HUMAN OTC DRUG CLINIQUE SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25 AVOBENZONE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20040401 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 5; 1.3; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 49527-712_c354f9e8-101b-43e7-a06f-016bbfb6fb8c 49527-712 HUMAN OTC DRUG EVEN BETTER MAKEUP SPF 15 EVENS AND CORRECTS OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE LIQUID TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 6; 2.9; 3.5 mL/100mL; mL/100mL; mL/100mL 49527-713_53f99ad0-776f-4fac-8a26-187a23321618 49527-713 HUMAN OTC DRUG ACNE SOLUTIONS OIL CONTROL CLEANSING MASK ACNE MEDICATION ALL SKIN TYPES SALICYLIC ACID CREAM TOPICAL 20070901 OTC MONOGRAPH FINAL part333 CLINIQUE LABORATORIES INC SALICYLIC ACID 1 mL/100mL 49527-715_2c8b206a-0889-4c92-ab7d-8c29bf3ffe1c 49527-715 HUMAN OTC DRUG Skin Supplies for Men antiperspirant Clinique Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20120223 OTC MONOGRAPH FINAL part350 CLINIQUE LABORATORIES INC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.6 g/100mL 49527-716_7a0ac6b2-61f0-47f2-bbeb-f6e50830d2b2 49527-716 HUMAN OTC DRUG CLINIQUE SPF 30 with SOLAR SMART octisalate, homosalate, oxybenzone, avobenzone, and octocrylene CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 5; 5; 2.7; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 49527-717_ed67f891-45eb-4ce2-a39e-91d71ec741a8 49527-717 HUMAN OTC DRUG SPF 50 with SOLAR SMART oxybenzone, octisalate, homosalate, avobenzone, and octocrylene CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 5; 5; 2.7; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 49527-718_8becbebb-d1e3-45aa-8a1f-43d5de0afc99 49527-718 HUMAN OTC DRUG ACNE SOLUTIONS EMERGENCY BENZOYL PEROXIDE LOTION TOPICAL 20001201 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC BENZOYL PEROXIDE 2.5 mL/100mL 49527-719_f887bd06-097b-4391-b4e4-68c1ce76cdd6 49527-719 HUMAN OTC DRUG REPAIRWEAR LIFT SPF 15 FIRMING DAY DRY COMBO SKIN OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20070401 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 3.5; 1 mL/100mL; mL/100mL; mL/100mL 49527-722_f22e64e9-8b07-4af1-9bbc-1978bf835562 49527-722 HUMAN OTC DRUG CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20071201 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC TITANIUM DIOXIDE; ZINC OXIDE 6.4; 2 mL/100mL; mL/100mL 49527-723_af89f625-9d44-4263-920e-a7c5b7e9c217 49527-723 HUMAN OTC DRUG ACNE SOLUTIONS CLARIFYING SALICYLIC ACID LIQUID TOPICAL 20060901 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC SALICYLIC ACID 1.5 mL/100mL 49527-724_8e5070fa-9ca7-4907-8136-da89d9c931dc 49527-724 HUMAN OTC DRUG ALMOST POWDER COMPACT MAKEUP SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20090501 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC TITANIUM DIOXIDE 6.9 g/100g 49527-727_147dcb1b-5838-4dd9-804a-b9f34a1db9fc 49527-727 HUMAN OTC DRUG HIGH IMPACT LIP COLOUR SPF 15 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; ZINC OXIDE 7.5; 2.1 g/100g; g/100g 49527-730_5759b0af-ab98-41ce-ac9f-9725d5788e26 49527-730 HUMAN OTC DRUG YOUTH SURGE SPF 15 AGE DECELERATING MOISTURIZER DRY COMBINATION SKIN OCTINOXATE OCTISALATE TITANIUM DIOXIDE CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 3.5; 1.2 mL/100mL; mL/100mL; mL/100mL 49527-731_11e55ace-e2c9-4c6d-b9ff-80c9ca3e4c1c 49527-731 HUMAN OTC DRUG YOUTH SURGE SPF 15 AGE DECELERATING MOISTURIZER ANTI RIDES HYDRATANT OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20090224 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; TITANIUM DIOXIDE 7.5; 1.4 mL/100mL; mL/100mL 49527-732_04e85925-302f-4bb0-af4d-13ba7ed29e1b 49527-732 HUMAN OTC DRUG YOUTH SURGE AGE DECELERATING MOISTURIZER SPF 15 octisalate, avobenzone, octocrylene, and homosalate CREAM TOPICAL 20080301 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 2; 5; 2.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 49527-734_ea862b96-2ee9-4a7a-81d9-3b7d88ab25e9 49527-734 HUMAN OTC DRUG CLINIQUE SPF 50 with SOLAR SMART ADVANCED PROTECTION oxybenzone, octisalate, homosalate, avobenzone, and octocrylene CREAM TOPICAL 20090302 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 5; 5; 2.7; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 49527-735_ccaf35c2-e800-4f09-9881-55decb422123 49527-735 HUMAN OTC DRUG CLINIQUE SPF 15 with SOLAR SMART ADVANCED PROTECTION homosalate, octisalate, avobenzone, and octocrylene CREAM TOPICAL 20090301 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 2.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 49527-736_dfbb4a0f-2878-48b2-b2d6-96c58c877f14 49527-736 HUMAN OTC DRUG CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM with SOLAR SMART octisalate, homosalate, oxybenzone, avobenzone, octocrylene CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABS INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 5; 5; 2.7; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 49527-743_cf9c4903-54d0-44ad-90a3-f61b6e78cbb2 49527-743 HUMAN OTC DRUG LONG LAST GLOSSWEAR SPF 15 OCTINOXATE, OCTISALATE LIQUID TOPICAL 20080301 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; OCTISALATE 7.5; 4 mL/100mL; mL/100mL 49527-746_2d8f51b5-b51b-47f3-b07d-de1345ea4990 49527-746 HUMAN OTC DRUG SUPERBALANCED MAKEUP SPF 15 MINERAL RICH FORMULA TITANIUM DIOXIDE POWDER TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE 6.3 g/100g 49527-749_8cfbc730-2097-4261-9011-1c76ba1a31a3 49527-749 HUMAN OTC DRUG ACNE SOLUTIONS CLEARING CONCEALER ACNE MEDICATION ALL SKIN TYPES SALICYLIC ACID LOTION TOPICAL 20080402 OTC MONOGRAPH FINAL part333 CLINIQUE LABORATORIES INC SALICYLIC ACID 1 mL/100mL 49527-750_99eda414-2647-4c41-8deb-7bf2b99141be 49527-750 HUMAN OTC DRUG CX DAILY EYE PROTECTOR SPF 15 TITANIUM DIOXIDE GEL TOPICAL 20020201 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC TITANIUM DIOXIDE 7.8 mL/100mL 49527-751_c31f35a5-ba3d-4b6e-8c2b-9fb47f952084 49527-751 HUMAN OTC DRUG ACNE SOLUTIONS LIQUID MAKEUP SALICYLIC ACID ACNE TREATMENT SALICYLIC ACID LIQUID TOPICAL 20090409 OTC MONOGRAPH FINAL part333 CLINIQUE LABORATORIES INC SALICYLIC ACID .5 mL/100mL 49527-759_1a87f014-4fd5-4ba5-9a47-a8276815f6d2 49527-759 HUMAN OTC DRUG EVEN BETTER SKIN TONE CORRECTING MOSTURIZER SPF 20 OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20090801 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES, INC. AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 2.7 mL/100mL; mL/100mL; mL/100mL 49527-760_6d32bd57-878f-461d-b31c-30d42da77028 49527-760 HUMAN OTC DRUG Age Defense BB Cream SPF 30 OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20100823 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 4; 2.5; 1.1; 3.5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 49527-800_9d821a45-3ceb-4b8c-a58c-08dc973fb934 49527-800 HUMAN OTC DRUG ALMOST POWDER MAKEUP SPF 15 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; TITANIUM DIOXIDE 2; 13 g/100g; g/100g 49527-801_ac87746b-ecb8-4446-a496-6f00d91cf549 49527-801 HUMAN OTC DRUG almost bronzer spf 15 titanium dioxide POWDER TOPICAL 20010901 OTC MONOGRAPH NOT FINAL part352 clinique laboratories inc TITANIUM DIOXIDE 9.8 g/100g 49527-825_8583e169-abb4-4ffb-92a7-7864b7538d6d 49527-825 HUMAN OTC DRUG ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION SALICYLIC ACID GEL TOPICAL 20081201 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC SALICYLIC ACID .5 mL/100mL 49527-886_35c7c68e-924c-487c-bdd9-be60717eb96a 49527-886 HUMAN OTC DRUG CLINIQUE skin supplies for men octinoxate, octisalate, avobenzone, and oxybenzone LOTION TOPICAL 20040901 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.4; 5; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 49527-920_e4f4efa2-ee46-4b31-9339-525ae422a616 49527-920 HUMAN OTC DRUG REPAIRWEAR ANTI -AGING MAKEUP SPF 15 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20050621 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE; ZINC OXIDE 12.6; 2 mL/100mL; mL/100mL 49527-942_9df7e655-0bff-4fab-8de4-7c5ec0b053fb 49527-942 HUMAN OTC DRUG SUPER CITY BLOCK SPF 40 OIL FREE DAILY FACE PROTECTOR zinc oxide, octinoxate, titanium dioxide, and octisalate CREAM TOPICAL 20040901 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 2; 6.6; 8.8 mL/100mL; mL/100mL; mL/100mL; mL/100mL 49527-953_3db07dee-3ef4-417d-a4ac-1a18421ddcb4 49527-953 HUMAN OTC DRUG CLINIQUE CX PROTECTIVE BASE SPF 40 OCTINOXATE, OCTISALATE, ZINC OXIDE,TITANIUM DIOXIDE CREAM TOPICAL 20050501 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 1.7; 4.6 mL/100mL; mL/100mL; mL/100mL; mL/100mL 49527-989_da7f4dee-33bc-4add-a1ba-821bd8e31644 49527-989 HUMAN OTC DRUG CITY BLOCK SHEER SPF 25 OIL FREE DAILY FACE PROTECTOR TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20061001 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE; ZINC OXIDE 7.3; 6.9 mL/100mL; mL/100mL 49527-992_e85134d9-61c5-4388-9e47-b0ad7e44a357 49527-992 HUMAN OTC DRUG ACNE SOLUTIONS CLEANSING FOAM salicylic acid LIQUID TOPICAL 20061212 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC SALICYLIC ACID 2 mL/100mL 49527-997_1d66e5cd-35ee-41e6-b39b-bcb45a7a275f 49527-997 HUMAN OTC DRUG ACNE SOLUTIONS CLEARING MOISTURIZER ACNE MEDICATION BENZOYL PEROXIDE LOTION TOPICAL 20060901 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC BENZOYL PEROXIDE 2.5 mL/100mL 49527-999_7747fb7f-1580-4b67-9ead-01b6c19cd5f4 49527-999 HUMAN OTC DRUG ACNE SOLUTIONS CLEANSING BAR FOR FACE AND BODY salicylic acid SOAP TOPICAL 20060401 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC SALICYLIC ACID 2 g/100g 49543-738_38497a7a-2859-4b3e-b4df-2fb3ac34e4fc 49543-738 HUMAN OTC DRUG Hansan Spray ALCOHOL LIQUID TOPICAL 20091231 OTC MONOGRAPH NOT FINAL part333 Nexgen ALCOHOL .7 mL/mL 49543-773_e755d227-f275-4f93-b7f4-79964d464f1c 49543-773 HUMAN OTC DRUG Hansan Foam ALCOHOL AEROSOL, FOAM TOPICAL 20091231 OTC MONOGRAPH NOT FINAL part333 Nexgen ALCOHOL 620 mg/g 49546-105_49c8e201-f161-457b-b152-3563075133f8 49546-105 HUMAN OTC DRUG Ivy-Dry Super BENZYL ALCOHOL, CAMPHOR, MENTHOL SPRAY TOPICAL 20120711 OTC MONOGRAPH NOT FINAL part348 Ivy-Dry, Inc. BENZYL ALCOHOL; CAMPHOR (SYNTHETIC); MENTHOL 10; .5; .25 mL/100mL; mL/100mL; mL/100mL 49546-106_09f9480f-f2e7-4275-afe3-001676e6a826 49546-106 HUMAN OTC DRUG Ivy-Dry Super BENZYL ALCOHOL, CAMPHOR, MENTHOL SPRAY TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part348 Ivy-Dry, Inc. BENZYL ALCOHOL; CAMPHOR (SYNTHETIC); MENTHOL 10; .5; .25 mL/100mL; mL/100mL; mL/100mL 49546-201_4b4d2721-d863-4065-92a5-723d9dd218f6 49546-201 HUMAN OTC DRUG Ivy Dry Benzyl Alcohol, Camphor, Menthol CREAM TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part348 Ivy Dry, Inc. BENZYL ALCOHOL; CAMPHOR (SYNTHETIC); MENTHOL 10; .6; .4 g/100g; g/100g; g/100g 49557-221_1a602bf9-674c-4705-bb9b-91f6dd1b6b4a 49557-221 HUMAN OTC DRUG High Five ALCOHOL GEL TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part333E Jani-Source, LLC ALCOHOL .7 mL/mL 49557-572_832c4566-d2e7-41d7-81be-5d6f663d9568 49557-572 HUMAN OTC DRUG High Five TRICLOSAN SOAP TOPICAL 20120425 OTC MONOGRAPH NOT FINAL part333E Jani-Source, LLC TRICLOSAN 3 mg/mL 49557-576_f7622198-fdd4-4157-a8ef-c26abd924e1d 49557-576 HUMAN OTC DRUG Foaming Antimicrobial TRICLOSAN SOAP TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part333E Jani-Source, LLC TRICLOSAN .003 mg/mL 49562-515_8802dcd8-3c4f-40a5-b017-ba5e808595dc 49562-515 HUMAN OTC DRUG Thario Instant Hand Sanitizer alcohol GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 Thario Building Services ALCOHOL 600 mL/1000mL 49571-001_361eb0b1-5496-440d-a64e-f8bc546c0321 49571-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19590101 UNAPPROVED MEDICAL GAS Capitol Welders Supply Co., Inc. OXYGEN 99 L/100L 49571-002_6b3f5412-501f-4a77-8496-c9c6206c689f 49571-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19590101 UNAPPROVED MEDICAL GAS Capitol Welders Supply Co., Inc. NITROGEN 99 L/100L 49571-003_316353e8-6be8-4131-bd62-e821509e53e1 49571-003 HUMAN PRESCRIPTION DRUG MEDICAL AIR AIR GAS RESPIRATORY (INHALATION) 19590101 UNAPPROVED MEDICAL GAS Capitol Welders Supply Co., Inc. OXYGEN 21 L/100L 49575-001_33e28248-fa32-467f-a285-0be268b0d27c 49575-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990615 NDA NDA205767 Machine & Welding Supply Company OXYGEN 992 mL/L 49575-002_79c9300b-0ea7-4633-ae29-0c13e3d172c5 49575-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19990615 NDA NDA205766 Machine & Welding Supply Company NITROGEN 990 mL/L 49575-003_8ac26b7c-db2c-4fb5-8281-df4b1a40ee05 49575-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19990615 NDA NDA205704 Machine & Welding Supply Company NITROUS OXIDE 990 mL/L 49575-004_dc392fc7-a8a1-46b3-9d01-a14fa6781ce3 49575-004 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19990615 NDA NDA205796 Machine & Welding Supply Company AIR 1000 mL/L 49580-0014_62faefde-a0a2-4236-866d-e5fa6fb4de55 49580-0014 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20131204 OTC MONOGRAPH NOT FINAL part356 Aaron Industries Inc (SC) HYDROGEN PEROXIDE 2.65 mL/100mL 49580-0024_81ac8883-d38a-4376-b6e3-ed64b7f2b3d5 49580-0024 HUMAN OTC DRUG Peptic Relief Maximum Strength Maximum Strength Pepto Bismol SUSPENSION ORAL 20131211 OTC MONOGRAPH FINAL part335 Aaron Industries, Inc. BISMUTH SUBSALICYLATE 525 mg/15mL 49580-0106_c1677ac4-15d2-40ba-9940-441fda5c0364 49580-0106 HUMAN OTC DRUG Antacid Antigas Mylanta SUSPENSION ORAL 20090408 OTC MONOGRAPH FINAL part331 Aaron Industries, Inc. ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 49580-0108_75a9f2e9-dba4-4a55-a151-912f735e8912 49580-0108 HUMAN OTC DRUG Milk of Magnesia Original Phillips Milk of magnesia Original SUSPENSION ORAL 20090813 OTC MONOGRAPH FINAL part334 Aaron Industries Inc. MAGNESIUM HYDROXIDE 1200 mg/15mL 49580-0110_cf245ddb-fd9c-4da1-a2b2-b7abc20cc5d8 49580-0110 HUMAN OTC DRUG Peptic Relief Pepto Bismol SUSPENSION ORAL 20100108 OTC MONOGRAPH FINAL part335 Aaron Industries, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL 49580-0115_103c67d7-102b-4c46-9f8c-929bacdaa301 49580-0115 HUMAN OTC DRUG Antacid Supreme Cherry Mylanta Supreme Cherry SUSPENSION ORAL 20090324 OTC MONOGRAPH FINAL part331 Aaron Industries, Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE 400; 135 mg/5mL; mg/5mL 49580-0122_5df719a4-3e77-494a-bd88-de6899133849 49580-0122 HUMAN OTC DRUG Antacid Antigas Maximum Strength Original Antacid Antigas Maximum Strength Mylanta Original SUSPENSION ORAL 20090409 OTC MONOGRAPH FINAL part331 Aaron Industries, Inc. ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 49580-0126_330a17a1-029d-4dd7-8203-c5bd9b79ce29 49580-0126 HUMAN OTC DRUG Tussin CF Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL Robitussin CF LIQUID ORAL 20050110 OTC MONOGRAPH FINAL part341 Aaron Industries Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 49580-0142_08d15545-f555-44d1-beb8-836ba1e13160 49580-0142 HUMAN OTC DRUG Day Time with PE Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20070102 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 49580-0155_aca10c35-feff-4015-9324-68f32e027fc7 49580-0155 HUMAN OTC DRUG Flu Relief Therapy Day Time Theraflu Daytime LIQUID ORAL 20131211 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 49580-0158_dba29ae6-8151-477d-816c-c713bfa55293 49580-0158 HUMAN OTC DRUG Childrens Mucus Relief Cough Cherry Childrens Mucinex Cough LIQUID ORAL 20131212 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 49580-0192_38da9ace-441f-4ad8-bd00-3affa282acfd 49580-0192 HUMAN OTC DRUG Day Time Cold Multi-Symptom Cool Blast Tylenol Multi Symptom Cool Blast Daytime LIQUID ORAL 20100101 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 49580-0210_d5be65c6-01fa-4c02-b875-f7fbf0cd65e8 49580-0210 HUMAN OTC DRUG Peptic Relief Maximum Strength Maximum Strength Pepto Bismol SUSPENSION ORAL 20090729 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. BISMUTH SUBSALICYLATE 525 mg/15mL 49580-0242_38a35cd7-4772-47cc-9c9c-27c5d6c35e74 49580-0242 HUMAN OTC DRUG EZ Nite Sleep ZzzQuil LIQUID ORAL 20130101 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 49580-0268_ad28cb35-6257-4310-b117-f962b00e1934 49580-0268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent ReadyInCase Hydrogen Peroxide LIQUID TOPICAL 20140831 OTC MONOGRAPH NOT FINAL part356 Aaron Industries Inc. HYDROGEN PEROXIDE 2.65 mL/100mL 49580-0271_5348bc67-3abe-4679-b16b-4ecf7bc0157b 49580-0271 HUMAN OTC DRUG Isopropyl alcohol 50 percent ReadyInCase Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A Aaron Industries Inc. ISOPROPYL ALCOHOL 50 mL/100mL 49580-0272_7e1199ab-6ad0-433e-a59b-fce5cde43ff7 49580-0272 HUMAN OTC DRUG Isopropyl alcohol 50 percent Wintergreen ReadyInCase Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A Aaron Industries Inc. ISOPROPYL ALCOHOL 50 mL/100mL 49580-0274_f96f6779-5fbb-4d31-a4b8-3507a94b6289 49580-0274 HUMAN OTC DRUG Ethyl alcohol 70 percent ReadyInCase Ethyl alcohol LIQUID TOPICAL 20140831 OTC MONOGRAPH NOT FINAL part333A Aaron Industries Inc. ALCOHOL 70 mL/100mL 49580-0275_07d07bdf-a5b6-4962-8976-da822238f28d 49580-0275 HUMAN OTC DRUG Isopropyl alcohol 70 percent ReadyInCase Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A Aaron Industries Inc. ISOPROPYL ALCOHOL 70 mL/100mL 49580-0276_66059d85-90b2-4dc2-9e65-5281c1caa310 49580-0276 HUMAN OTC DRUG Isopropyl alcohol 70 percent Wintergreen ReadyInCase Isopropyl alcohol LIQUID TOPICAL 20140831 OTC MONOGRAPH NOT FINAL part333A Aaron Industries Inc. ISOPROPYL ALCOHOL 70 mL/100mL 49580-0277_8e3609d6-fb3d-405c-9a2f-b38dca88086a 49580-0277 HUMAN OTC DRUG Isopropyl alcohol 91 percent ReadyInCase Isopropyl alcohol LIQUID TOPICAL 20140831 OTC MONOGRAPH NOT FINAL part333A Aaron Industries Inc. ISOPROPYL ALCOHOL 91 mL/100mL 49580-0300_c5fe260c-a9f2-44d7-bc95-45217e4eca8d 49580-0300 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID ORAL; TOPICAL 20090730 OTC MONOGRAPH NOT FINAL part356 Aaron Industries, Inc. HYDROGEN PEROXIDE 2.65 mL/100mL 49580-0300_c6e23804-15cb-4213-bcd1-341b99297b25 49580-0300 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090702 OTC MONOGRAPH NOT FINAL part356 Aaron Industries, Inc. HYDROGEN PEROXIDE 2.65 mL/100mL 49580-0329_db8f62f5-7318-44ca-ada3-3c7cf5b1b268 49580-0329 HUMAN OTC DRUG Magnesium Citrate Lemon ReadyInCase Magnesium citrate LIQUID ORAL 20140630 OTC MONOGRAPH NOT FINAL part334 Aaron Industries Inc. MAGNESIUM CITRATE 1.745 g/29.6mL 49580-0334_1ec2e5a9-7f87-4075-a1b4-02b7eb31948f 49580-0334 HUMAN OTC DRUG Mineral oil Mineral oil OIL ORAL 20140831 OTC MONOGRAPH NOT FINAL part334 Aaron Industries Inc. MINERAL OIL 100 mg/100mL 49580-0343_fab9f496-80de-4c5e-8883-8489df97b1f5 49580-0343 HUMAN OTC DRUG Night Time Cold and Flu ReadyInCase Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Aaron Industries Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 49580-0344_1077c176-7378-4fab-9319-081b4f854059 49580-0344 HUMAN OTC DRUG Nighttime Cold and Flu ReadyInCase Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Aaron Industries Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 49580-0345_58512b4d-423b-4ef4-9256-1a3dce6c0d2b 49580-0345 HUMAN OTC DRUG Nighttime Cough all night cough relief Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140731 OTC MONOGRAPH FINAL part341 Aaron Industries Inc. DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 49580-0372_056192eb-dac1-41dd-9d7d-78719d982713 49580-0372 HUMAN OTC DRUG Stomach Relief Regular Strength ReadyInCase Bismuth subsalicylate LIQUID ORAL 20140930 OTC MONOGRAPH FINAL part335 Aaron Industries Inc. BISMUTH SUBSALICYLATE 525 mg/30mL 49580-0383_18db0cd1-6829-4f19-a41d-68b2fff2ca9d 49580-0383 HUMAN OTC DRUG Tussin Long Acting Cough ReadyInCase Dextromethorphan HBr LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Aaron Industries Inc. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 49580-0384_8f522fe3-26fc-42ca-b762-09491b87c3f4 49580-0384 HUMAN OTC DRUG Tussin DM Cough and Chest Congestion sugar-free ReadyInCase Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Aaron Industries Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 49580-0390_79b00658-f882-4884-ae9e-1ed2503e20ff 49580-0390 HUMAN OTC DRUG Witch Hazel ReadyInCase Witch hazel LIQUID TOPICAL 20140831 OTC MONOGRAPH FINAL part347 Aaron Industries Inc. WITCH HAZEL 842 mg/mL 49580-0403_eec12ddd-ebf8-4e74-a819-721a7b7ae752 49580-0403 HUMAN OTC DRUG Night Time Cherry Pseudo-Free NyQuil Cherry LIQUID ORAL 20091103 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 49580-0408_d0b6356c-6332-4501-96a0-0483cc4a7f1f 49580-0408 HUMAN OTC DRUG Childrens Acetaminophen Oral Suspension Grape Flavor Acetaminophen SUSPENSION ORAL 20090729 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. ACETAMINOPHEN 160 mg/5mL 49580-0413_de00ae10-0462-49c0-b08c-63ca5a248462 49580-0413 HUMAN OTC DRUG Tussin Original Robitussin LIQUID ORAL 20090116 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. GUAIFENESIN 100 mg/5mL 49580-0413_fdc96293-f625-4b57-bb54-232485b820b3 49580-0413 HUMAN OTC DRUG Tussin Original Robitussin LIQUID ORAL 20090116 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. GUAIFENESIN 100 mg/5mL 49580-0434_11da15b6-7dd8-4e78-b0cb-bd3a41f6480f 49580-0434 HUMAN OTC DRUG Tussin Sugar Free Cough Robitussin Sugar Free Cough LIQUID ORAL 20080924 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 49580-0901_efe3165a-55c0-4cfa-baa9-eecd0a20fbe2 49580-0901 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090714 OTC MONOGRAPH FINAL part333 Aaron Industries, Inc. ISOPROPYL ALCOHOL 50 mL/100mL 49580-0902_be1156ca-4bd0-438f-bee8-eab7b3584259 49580-0902 HUMAN OTC DRUG 91 Percent Isopropyl alcohol Isopropyl alcohol LIQUID TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part333A Aaron Industries Inc. ISOPROPYL ALCOHOL 91 mL/100mL 49580-0905_711d6363-f5df-467e-aee0-8a0ec47d5fb2 49580-0905 HUMAN OTC DRUG Ethyl Rubbing Alcohol Ethyl Rubbing Alcohol LIQUID TOPICAL 20091003 OTC MONOGRAPH FINAL part333 Aaron Industries, Inc. ALCOHOL 70 mL/100mL 49580-0911_624bded1-4875-40e3-8323-d231267dab44 49580-0911 HUMAN OTC DRUG Iso-Blu Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090402 OTC MONOGRAPH FINAL part333 Aaron Industries, Inc. ISOPROPYL ALCOHOL 50 mL/100mL 49580-1108_301d383c-0455-4d7a-ae91-8d315b942673 49580-1108 HUMAN OTC DRUG Milk of Magnesia Mint MAGNESIUM HYDROXIDE SUSPENSION ORAL 20090708 OTC MONOGRAPH FINAL part334 Aaron Industries Inc. MAGNESIUM HYDROXIDE 1200 mg/15mL 49580-1403_f251c128-c486-4c73-8533-5aa7ded1b786 49580-1403 HUMAN OTC DRUG Night Time Cherry Pseudo-Free NyQuil Cherry LIQUID ORAL 20051108 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 49580-1403_f6aee0bc-9fe4-432a-8664-8a2186163bcf 49580-1403 HUMAN OTC DRUG Night Time Cherry Pseudo-Free NyQuil Cherry LIQUID ORAL 20090708 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 49580-1406_5d701d5a-9b60-4fdc-a2d1-03451c87ad76 49580-1406 HUMAN OTC DRUG Night Time Original Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090123 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 49580-1406_d4e6309a-fce8-481a-aad4-9a166ace457c 49580-1406 HUMAN OTC DRUG Night Time Original Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20091029 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 49580-1417_b0eb9524-5c62-4687-a975-5c5e44570114 49580-1417 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20090729 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 49580-1434_c4cf7956-bedb-44d0-99e9-b800b0b7d7e9 49580-1434 HUMAN OTC DRUG Childrens Plus Multi-Symptom Cold Grape with PE Childrens Tylenol Plus Multi-Symptom Cold SUSPENSION ORAL 20090101 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 49580-2004_1960fdd9-d353-431c-855a-d61b39a51a0d 49580-2004 HUMAN OTC DRUG Flu Relief Therapy Night Time Acetaminophen, DIPHENHYDRAMINE HYDROCHLORIDE, Phenylephrine Hydrochloride LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL 49580-2104_18350107-ba14-4d3d-b496-8ddda803f640 49580-2104 HUMAN OTC DRUG Flu Relief Therapy Day Time Theraflu Daytime LIQUID ORAL 20090921 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 49580-2411_4e1ac9c7-e088-44d6-88c0-a6ac9aab7082 49580-2411 HUMAN OTC DRUG Tussin CF Robitussin CF LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Aaron Industries Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 49580-2412_ff196a21-d157-46ae-9255-ed78664c7860 49580-2412 HUMAN OTC DRUG Triacting Cough and Sore Throat Grape Triaminic Cough and Sore Throat LIQUID ORAL 20090203 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 7.5 mg/5mL; mg/5mL 49580-3104_38826d02-7d7f-4e84-bc07-0af8190dbb67 49580-3104 HUMAN OTC DRUG Cough Relief Orange DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20091121 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 49580-3164_b688bd8f-2c22-4fed-8dbd-4f0ed85994eb 49580-3164 HUMAN OTC DRUG Cough Relief Orange DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20090713 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 49580-3210_c8114fa8-938f-4df1-bd97-df5a2d8ef529 49580-3210 HUMAN OTC DRUG Peptic Relief Maximum Strength Maximum Strength Pepto Bismol SUSPENSION ORAL 20090806 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. BISMUTH SUBSALICYLATE 525 mg/15mL 49580-3304_f380662d-589c-4702-a188-cc23a8ac307b 49580-3304 HUMAN OTC DRUG Childrens Mucus Relief Cough Cherry DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20090203 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 49580-3412_c18efabd-24c7-4eba-9873-aff88ea02bf4 49580-3412 HUMAN OTC DRUG Tussin Cough Long Acting Robitussin Cough Long Acting LIQUID ORAL 20100113 OTC MONOGRAPH FINAL part341 Aaron Industries Inc DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL 49580-3414_bf9a43a4-0746-4b9b-91ea-b695f6f700a4 49580-3414 HUMAN OTC DRUG Childrens Acetaminophen Oral Suspension Grape Flavor Acetaminophen SUSPENSION ORAL 20090729 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. ACETAMINOPHEN 160 mg/5mL 49580-3416_f5047012-047f-4a7a-8902-385ce6c572ae 49580-3416 HUMAN OTC DRUG Day Time with PE DayQuil LIQUID ORAL 20070102 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 49580-3444_7aeb33fe-a73f-44d4-89a8-b272fd86f2d4 49580-3444 HUMAN OTC DRUG Dye-Free Childrens Acetaminophen Grape Acetaminophen SUSPENSION ORAL 20090623 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. ACETAMINOPHEN 160 mg/5mL 49580-4406_7e5e9ce5-3493-49d3-bc7e-101d20c64b65 49580-4406 HUMAN OTC DRUG Sore Throat Spray Cherry Phenol LIQUID ORAL 20090801 OTC MONOGRAPH NOT FINAL part356 Aaron Industries, Inc. PHENOL 1.5 g/100mL 49580-4506_b68cf57b-0fad-4520-880a-e5d8d1b007fe 49580-4506 HUMAN OTC DRUG Phenol Sore Throat Spray LIQUID ORAL 20090801 OTC MONOGRAPH NOT FINAL part356 Aaron Industries, Inc. PHENOL 1.5 g/100mL 49589-101_dac1ae9f-ee3c-4099-b114-5d99b079795d 49589-101 HUMAN OTC DRUG Perio GS Hydrocotyle asiatica, Echinacea purpurea, and Sambucus Nigra Flower GEL TOPICAL 20091101 UNAPPROVED HOMEOPATHIC Izun Pharmaceuticals Corporation ECHINACEA PURPUREA; HYDROCOTYLE ASIATICA; SAMBUCUS NIGRA FLOWER .23; .46; 5.1 mg/1; mg/1; mg/1 49589-102_de24a080-4009-4150-abb1-06622b29db02 49589-102 HUMAN OTC DRUG SOOTHE AND CURE Hydrocotyle asiatica, Echinacea purpurea, and Sambucus Nigra Flower GEL TOPICAL 20091101 UNAPPROVED HOMEOPATHIC Izun Pharmaceuticals Corporation ECHINACEA PURPUREA; HYDROCOTYLE ASIATICA; SAMBUCUS NIGRA FLOWER .35; .7; 5.95 mg/1; mg/1; mg/1 49589-103_039450a4-91be-49c3-a0bb-cd1359709d77 49589-103 HUMAN OTC DRUG IZUNRINSE Hydrocotyle asiatica, Echinacea purpurea, and Sambucus Nigra Flower MOUTHWASH TOPICAL 20091101 UNAPPROVED HOMEOPATHIC Izun Pharmaceuticals Corporation ECHINACEA PURPUREA; HYDROCOTYLE ASIATICA; SAMBUCUS NIGRA FLOWER .25; .5; 4.25 g/mL; g/mL; g/mL 49589-111_ab5f5b64-3741-43d0-bee0-2fbe091947fa 49589-111 HUMAN OTC DRUG PeriActive Sambucus nigra flower, Echinacea purpurea, and Centella Asiatica MOUTHWASH TOPICAL 20090111 UNAPPROVED HOMEOPATHIC Izun Pharmaceutical Corporation CENTELLA ASIATICA; ECHINACEA PURPUREA; SAMBUCUS NIGRA FLOWER 4; 4; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49609-101_2e867d1a-d7ff-4276-9999-20a2c24b5611 49609-101 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F-18 INJECTION INTRAVENOUS 20111208 UNAPPROVED DRUG OTHER IBA Molecular North America, Inc. FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 49609-102_5b35632d-8fba-4ab7-8071-f1295bdc65e8 49609-102 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F-18 INJECTION INTRAVENOUS 20111208 UNAPPROVED DRUG OTHER IBA Molecular North America, Inc. SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 49609-201_e3a28cdb-bade-417f-8a20-cb72d3f7dc5d 49609-201 HUMAN PRESCRIPTION DRUG Ammonia N 13 Ammonia N-13 INJECTION INTRAVENOUS 20130131 UNAPPROVED DRUG OTHER IBA Molecular North America Inc. AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 49614-114_f146ca7a-c5b5-42fd-adb5-e8e68ebf0b5f 49614-114 HUMAN OTC DRUG headache relief added strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19920409 OTC MONOGRAPH NOT FINAL part343 Medicine Shoppe International Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 49614-116_bcf9c1de-8383-41b4-a2aa-7a3a2796c308 49614-116 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880315 ANDA ANDA072096 Medicine Shoppe International Inc IBUPROFEN 200 mg/1 49614-118_fc7d071e-dc91-4cef-84ae-b98778412200 49614-118 HUMAN OTC DRUG pain relief regular strength Acetaminophen TABLET ORAL 19870715 OTC MONOGRAPH NOT FINAL part343 Medicine Shoppe International Inc ACETAMINOPHEN 325 mg/1 49614-123_67dadaa3-3794-4629-9806-493fb0250404 49614-123 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET ORAL 19870715 OTC MONOGRAPH NOT FINAL part343 Medicine Shoppe International Inc ACETAMINOPHEN 500 mg/1 49614-131_22cdf899-52f4-417f-93e4-a42881bd11cf 49614-131 HUMAN OTC DRUG The Medicine Shoppe Gentle Laxative Bisacodyl TABLET ORAL 20111014 OTC MONOGRAPH NOT FINAL part334 The Medicine Shoppe International BISACODYL 5 mg/1 49614-133_39b6ed99-c766-4ee9-87a6-f953c0742ddc 49614-133 HUMAN OTC DRUG Bisacodyl Laxative bisacodyl SUPPOSITORY RECTAL 20080308 OTC MONOGRAPH FINAL part334 Medicine Shoppe International Inc BISACODYL 10 mg/1 49614-134_ce463dcc-6a04-47be-83c4-b44221589a4f 49614-134 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 19890621 OTC MONOGRAPH NOT FINAL part334 Medicine Shoppe International MAGNESIUM CITRATE 1.745 g/29.6mL 49614-142_ded735d3-6b13-4ab8-8f39-6c3b5d7deaa5 49614-142 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET, FILM COATED ORAL 20010903 ANDA ANDA074661 Medicine Shoppe International Inc NAPROXEN SODIUM 220 mg/1 49614-146_4f4aa9b1-c609-4928-85b4-2ca823c30d24 49614-146 HUMAN OTC DRUG sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20010619 OTC MONOGRAPH FINAL part338 Medicine Shoppe International Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49614-155_0edc6548-2d22-48e9-8f1f-6cd64096396c 49614-155 HUMAN OTC DRUG ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090427 ANDA ANDA079113 Medicine Shoppe International Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 49614-170_546ad538-0d4f-4ef8-a603-8984cbe64091 49614-170 HUMAN OTC DRUG Medicine Shoppe Loratadine Allergy Relief Loratadine TABLET ORAL 20030819 ANDA ANDA076134 The Medicine Shoppe International LORATADINE 10 mg/1 49614-172_47920893-349e-4826-88d7-83ebfc149794 49614-172 HUMAN OTC DRUG Medicine Shoppe Allergy Relief D24 Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 The Medicine Shoppe International LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 49614-174_14033efa-adbe-42e6-8c67-8311464554cf 49614-174 HUMAN OTC DRUG Allergy Relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Medicine Shoppe International Inc LORATADINE 5 mg/5mL 49614-175_0a8c845b-6fe7-4b79-8b89-40d963455ccf 49614-175 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 19951019 OTC MONOGRAPH NOT FINAL part343 Medicine Shoppe International Inc ACETAMINOPHEN 160 mg/5mL 49614-178_558b22fc-cc05-4fc8-9191-57e8fc0c0b0b 49614-178 HUMAN OTC DRUG acid control original strength Famotidine TABLET ORAL 20091019 ANDA ANDA075400 Medicine Shoppe International Inc FAMOTIDINE 10 mg/1 49614-188_b9646419-2265-4016-b61a-26ecaa017ac8 49614-188 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 19941120 OTC MONOGRAPH NOT FINAL part343 Medicine Shoppe International Inc ACETAMINOPHEN 500 mg/1 49614-191_ad868cf2-c7c5-42db-a1cc-8f68983b1779 49614-191 HUMAN OTC DRUG Soothing Bath Treatment Colloidal Oatmeal POWDER TOPICAL 20030717 OTC MONOGRAPH FINAL part347 Medicine Shoppe International Inc OATMEAL 1 g/g 49614-220_c0b66aaf-b40d-4827-ae13-549d1ddef96c 49614-220 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20090611 ANDA ANDA076760 Medicine Shoppe International Inc RANITIDINE HYDROCHLORIDE 75 mg/1 49614-221_492729bf-8e0d-4cba-b46b-01edf0d4fb47 49614-221 HUMAN OTC DRUG Alcohol Prep Pads with Pain Relief alcohol and benzocaine SWAB TOPICAL 20070628 OTC MONOGRAPH NOT FINAL part348 Medicine Shoppe International Inc BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 49614-228_2e4c10e7-aaf1-4f9b-9a1e-bf7c3775eb04 49614-228 HUMAN OTC DRUG anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 20080206 UNAPPROVED DRUG OTHER Medicine Shoppe International Inc DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 49614-229_32175404-18f6-49a2-b6c2-a51b58ab3c63 49614-229 HUMAN OTC DRUG All Day Allergy Cetirizine Hydrochloride TABLET ORAL 20080116 ANDA ANDA078336 Medicine Shoppe International Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 49614-310_b504f574-f87f-4149-b453-6637747e4ffc 49614-310 HUMAN OTC DRUG Tussin Adult chest congestion Guaifenesin SYRUP ORAL 19921103 OTC MONOGRAPH FINAL part341 Medicine Shoppe International Inc GUAIFENESIN 100 mg/5mL 49614-313_5997b650-9817-46d5-b58b-5e8d58ceaa03 49614-313 HUMAN OTC DRUG Pain Relief Infants Acetaminophen SUSPENSION/ DROPS ORAL 19870715 OTC MONOGRAPH NOT FINAL part343 Medicine Shoppe International Inc ACETAMINOPHEN 80 mg/.8mL 49614-331_cf32d6f6-e93f-47dd-bdc8-b3367b02cf40 49614-331 HUMAN OTC DRUG enema Saline ENEMA RECTAL 20091120 OTC MONOGRAPH NOT FINAL part334 Medicine Shoppe International Inc SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 49614-332_a6ba49ae-d6a7-4a75-ae9c-fb9526afa390 49614-332 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide LIQUID ORAL 19910215 OTC MONOGRAPH NOT FINAL part334 Medicine Shoppe International Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 49614-339_a8257665-2282-4b88-8430-927e884fa0dc 49614-339 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide LIQUID ORAL 20030224 OTC MONOGRAPH NOT FINAL part334 Medicine Shoppe International Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 49614-360_6f3ce3ed-7295-4543-9980-16692bd4e724 49614-360 HUMAN OTC DRUG Tussin DM adult cough and chest congestion Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20010221 OTC MONOGRAPH FINAL part341 Medicine Shoppe International Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 49614-361_aa0abb15-8cf5-44da-81d6-2e9ec9865b53 49614-361 HUMAN OTC DRUG antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20021107 OTC MONOGRAPH FINAL part332 Medicine Shoppe International Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 49614-404_aab81888-3f53-4f5d-814f-193835e923f4 49614-404 HUMAN OTC DRUG Medi-Cortisone with Aloe Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Medicine Shoppe International Inc HYDROCORTISONE 1 g/100g 49614-412_0b6e3b61-2a63-4faf-ac17-b7ba9b986aea 49614-412 HUMAN OTC DRUG The Medicine Shoppe Extra Strength Pain Relieving MENTHOL GEL TOPICAL 20120126 OTC MONOGRAPH FINAL part348 Medicine Shoppe International Inc MENTHOL 3.5 mL/100mL 49614-428_22430be2-d857-47e7-a0fa-baf9159586a3 49614-428 HUMAN OTC DRUG gas relief Simethicone CAPSULE, LIQUID FILLED ORAL 19981223 OTC MONOGRAPH FINAL part332 Medicine Shoppe International Inc DIMETHICONE 125 mg/1 49614-439_c2260abb-fd14-4052-8315-13925d44ba69 49614-439 HUMAN OTC DRUG Pain Relief PM Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19921103 OTC MONOGRAPH FINAL part338 Medicine Shoppe International Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 49614-448_882bb8d4-69fc-4ce8-97d4-e062d6b8ad52 49614-448 HUMAN OTC DRUG The Medicine Shoppe Chest Congestion Relief Guaifenesin TABLET ORAL 20050301 OTC MONOGRAPH FINAL part341 Medicine Shoppe International Inc GUAIFENESIN 400 mg/1 49614-462_799b6196-177c-496d-994f-c3ca6186861f 49614-462 HUMAN OTC DRUG Allergy Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part336 Medicine Shoppe International Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49614-467_27b89093-b3e4-4bb0-84a9-23c215b8d061 49614-467 HUMAN OTC DRUG aspirin adult low dose Aspirin TABLET, CHEWABLE ORAL 19970522 OTC MONOGRAPH NOT FINAL part343 Medicine Shoppe International Inc ASPIRIN 81 mg/1 49614-473_deaaaeb4-2919-4131-916f-1ba2018cb5b5 49614-473 HUMAN OTC DRUG Medicine Shoppe Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 The Medicine Shoppe International ACETAMINOPHEN 650 mg/1 49614-535_0394a5e2-5390-4b89-baf2-dd4b8ec5dc4d 49614-535 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET, COATED ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 Medicine Shoppe International Inc ASPIRIN 81 mg/1 49614-622_7e805afe-736c-4935-81f2-a23653a892d4 49614-622 HUMAN OTC DRUG Alcohol Pad isopropyl alcohol SWAB TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part333E Medicine Shoppe International Inc ISOPROPYL ALCOHOL .7 mL/1 49614-647_68ba3f33-06b3-414f-9a05-ff8fef4ac581 49614-647 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 19900215 ANDA ANDA072096 Medicine Shoppe International Inc IBUPROFEN 200 mg/1 49614-897_ee0587c0-7ef7-428c-8d46-1fba82e18d14 49614-897 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990109 ANDA ANDA074937 Medicine Shoppe International Inc IBUPROFEN 100 mg/5mL 49631-178_49f7d5eb-9883-c0c5-5fa6-ff3055d827d6 49631-178 HUMAN OTC DRUG Ohtas Isan Antacid Calcium carbonate, sodium bicarbonate POWDER ORAL 20001016 OTC MONOGRAPH FINAL part331 OHTA'S ISAN CO., LTD CALCIUM CARBONATE; SODIUM BICARBONATE 1; 1 g/g; g/g 49631-182_18ea7d4b-fc53-f158-0e6c-fe4ce795325c 49631-182 HUMAN OTC DRUG Ohtas Isan Antacid magnesium aluminosilicate, Calcium carbonate, sodium bicarbonate TABLET ORAL 20001116 OTC MONOGRAPH FINAL part331 OHTA'S ISAN CO., LTD ALMASILATE; CALCIUM CARBONATE; SODIUM BICARBONATE 125; 200; 200 mg/1; mg/1; mg/1 49631-212_bd89caaa-d992-517d-1477-130c534046f0 49631-212 HUMAN OTC DRUG Ohtas Isan Antacid magnesium aluminosilicate, Calcium carbonate, sodium bicarbonate TABLET ORAL 20121201 OTC MONOGRAPH FINAL part331 OHTA'S ISAN CO., LTD ALMASILATE; CALCIUM CARBONATE; SODIUM BICARBONATE 83.3; 133.3; 133.3 mg/1; mg/1; mg/1 49638-001_7d323d29-531f-49d0-b123-b0a9b026429a 49638-001 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET ORAL 20120515 OTC MONOGRAPH FINAL part343 America Medic ASPIRIN 81 mg/1 49638-002_91ec78d4-1907-43b7-a6d1-0d286b20a3c5 49638-002 HUMAN OTC DRUG TYLO Extra Strength Acetaminophen TABLET ORAL 20120515 OTC MONOGRAPH FINAL part343 America Medic ACETAMINOPHEN 500 mg/1 49643-003_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-003 NON-STANDARDIZED ALLERGENIC Cattle Epithelia Cattle Epithelia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. BOS TAURUS SKIN 1 g/10mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-004_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-004 NON-STANDARDIZED ALLERGENIC Cotton Linters Cotton Linters INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. COTTON FIBER 1 g/10mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-005_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-005 NON-STANDARDIZED ALLERGENIC Cottonseed Cottonseed INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. COTTON SEED 1 g/10mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 49643-006_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-006 NON-STANDARDIZED ALLERGENIC Dog Hair Dog Hair INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR 1 g/10mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-008_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-008 NON-STANDARDIZED ALLERGENIC House Dust House Dust INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. HOUSE DUST 1 g/50mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 49643-010_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-010 NON-STANDARDIZED ALLERGENIC Flaxseed Flaxseed INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. FLAX SEED 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 49643-011_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-011 NON-STANDARDIZED ALLERGENIC Goat Epithelia Goat Epithelia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CAPRA HIRCUS SKIN 1 g/20mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-012_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-012 NON-STANDARDIZED ALLERGENIC Guinea Pig Epithelia Guinea Pig Epithelia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CAVIA PORCELLUS SKIN 1 g/20mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-013_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-013 NON-STANDARDIZED ALLERGENIC Hamster Epithelia Hamster Epithelia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. MESOCRICETUS AURATUS SKIN 1 g/20mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-014_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-014 NON-STANDARDIZED ALLERGENIC Hog Epithelia Hog Epithelia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. SUS SCROFA SKIN 1 g/20mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-015_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-015 NON-STANDARDIZED ALLERGENIC Horse Epithelia Horse Epithelia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. EQUUS CABALLUS SKIN 1 g/10mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-016_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-016 NON-STANDARDIZED ALLERGENIC Jute Jute INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CORCORUS CAPSULARIS FIBER 1 g/10mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-017_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-017 NON-STANDARDIZED ALLERGENIC Kapok Kapok INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CEIBA PENTANDRA FIBER 1 g/10mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-018_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-018 NON-STANDARDIZED ALLERGENIC Karaya Gum Karaya Gum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. KARAYA GUM 1 g/100mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-019_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-019 NON-STANDARDIZED ALLERGENIC Mouse Epithelia Mouse Epithelia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. MUS MUSCULUS SKIN 1 g/10mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-020_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-020 NON-STANDARDIZED ALLERGENIC Orris Root Orris Root INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. IRIS GERMANICA VAR. FLORENTINA RHIZOME 1 g/10mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient] 49643-021_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-021 NON-STANDARDIZED ALLERGENIC Sisal Sisal INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. AGAVE SISALANA FIBER 1 g/10mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-022_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-022 NON-STANDARDIZED ALLERGENIC Tobacco Leaf Tobacco Leaf INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. TOBACCO LEAF 1 g/10mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 49643-047_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-047 NON-STANDARDIZED ALLERGENIC Cockroach, American Periplaneta americana INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. PERIPLANETA AMERICANA 1 g/10mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-048_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-048 NON-STANDARDIZED ALLERGENIC Cockroach, German Blattella germanica INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. BLATELLA GERMANICA 1 g/10mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-101_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-101 NON-STANDARDIZED ALLERGENIC Alternaria Alternaria alternata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ALTERNARIA ALTERNATA 1 g/10mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-104_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-104 NON-STANDARDIZED ALLERGENIC Botrytis Botrytis cinerea INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. BOTRYTIS CINEREA 1 g/10mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-105_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-105 NON-STANDARDIZED ALLERGENIC Candida Candida albicans INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CANDIDA ALBICANS 1 g/20mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 49643-106_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-106 NON-STANDARDIZED ALLERGENIC Cephalosporium Cephalosporium roseum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CEPHALOSPORIUM ROSEUM 1 g/10mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-107_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-107 NON-STANDARDIZED ALLERGENIC Chaetomium Chaetomium globosum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CHAETOMIUM GLOBOSUM 1 g/10mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-108_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-108 NON-STANDARDIZED ALLERGENIC Cladosporium Cladosporium herbarum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CLADOSPORIUM HERBARUM 1 g/10mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-109_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-109 NON-STANDARDIZED ALLERGENIC Curvularia Curvularia lunata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. COCHLIOBOLUS LUNATUS 1 g/10mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-110_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-110 NON-STANDARDIZED ALLERGENIC Epicoccum Epicoccum nigrum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. EPICOCCUM NIGRUM 1 g/10mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49643-111_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-111 NON-STANDARDIZED ALLERGENIC Fusarium Fusarium solani INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. HAEMATONECTRIA HAEMATOCOCCA 1 g/10mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-112_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-112 NON-STANDARDIZED ALLERGENIC Helminthosporium sativum Helminthosporium sativum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. COCHLIOBOLUS SATIVUS 1 g/10mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-113_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-113 NON-STANDARDIZED ALLERGENIC Monilia Monilia sitophila INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CHRYSONILIA SITOPHILA 1 g/10mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-114_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-114 NON-STANDARDIZED ALLERGENIC Mucor Mucor racemosus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. MUCOR RACEMOSUS 1 g/10mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-115_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-115 NON-STANDARDIZED ALLERGENIC Penicillium Penicillium chrysogenum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 1 g/10mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-116_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-116 NON-STANDARDIZED ALLERGENIC Phoma Phoma betae INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. PLEOSPORA BETAE 1 g/10mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-117_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-117 NON-STANDARDIZED ALLERGENIC Pullularia Pullularia pullulans INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 1 g/100mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-118_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-118 NON-STANDARDIZED ALLERGENIC Rhizopus Rhizopus oryzae INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 1 g/10mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-120_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-120 NON-STANDARDIZED ALLERGENIC Rust, Wheat Puccinia striiformis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. PUCCINIA STRIIFORMIS VAR. STRIIFORMIS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-122_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-122 NON-STANDARDIZED ALLERGENIC Smut, Corn Ustilago maydis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. USTILAGO MAYDIS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-123_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-123 NON-STANDARDIZED ALLERGENIC Smut, Johnson Grass Sphacelotheca cruenta INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. SPORISORIUM CRUENTUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-124_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-124 NON-STANDARDIZED ALLERGENIC Smut, Wheat Tilletia caries (tritici) INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. TILLECIA CARIES 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-126_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-126 NON-STANDARDIZED ALLERGENIC Stemphylium Stemphylium botryosum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. PLEOSPORA TARDA 1 g/10mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-128_f7d4e8ff-edb0-4e5c-a1b6-72635e9b2e3a 49643-128 HUMAN PRESCRIPTION DRUG Trichophyton for Intradermal Skin Testing Trichophyton mentagrophytes and Trichophyton rubrum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 20070815 BLA BLA102211 Allermed Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES; TRICHOPHYTON RUBRUM 1; 1 g/1000mL; g/1000mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-130_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-130 NON-STANDARDIZED ALLERGENIC Aspergillus fumigatus Aspergillus fumigatus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ASPERGILLUS FUMIGATUS 1 g/10mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-138_32ded8da-98ea-4cda-b49e-16d4491c8ade 49643-138 STANDARDIZED ALLERGENIC Candin Candida albicans Skin Test Antigen INJECTION, SOLUTION INTRADERMAL 19951201 BLA BLA103257 Allermed Laboratories, Inc. CANDIDA ALBICANS 1 U/.1mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 49643-300_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-300 NON-STANDARDIZED ALLERGENIC Alfalfa Pollen Medicago sativa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. MEDICAGO SATIVA POLLEN 1 g/50mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-301_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-301 NON-STANDARDIZED ALLERGENIC Acacia Pollen Acacia spp. INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ACACIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-302_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-302 NON-STANDARDIZED ALLERGENIC Coast Maple Pollen Acer macrophyllum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ACER MACROPHYLLUM POLLEN 1 g/20mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 49643-303_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-303 NON-STANDARDIZED ALLERGENIC Box Elder Maple Pollen Acer negundo INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ACER NEGUNDO POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-304_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-304 NON-STANDARDIZED ALLERGENIC Silver Maple Pollen Acer saccharinum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ACER SACCHARINUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-305_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-305 NON-STANDARDIZED ALLERGENIC Western Waterhemp Pollen Acnida tamariscina INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-307_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-307 NON-STANDARDIZED ALLERGENIC Quackgrass Pollen Agropyron repens INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ELYMUS REPENS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-308_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-308 NON-STANDARDIZED ALLERGENIC Western Wheatgrass Pollen Agropyron smithii INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. PASCOPYRUM SMITHII POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-309_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-309 HUMAN PRESCRIPTION DRUG Standardized Redtop Grass Agrostis alba INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102218 Allermed Laboratories, Inc. AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-310_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-310 NON-STANDARDIZED ALLERGENIC Tree of Heaven Pollen Ailanthus altissima INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-311_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-311 NON-STANDARDIZED ALLERGENIC Iodine Bush Pollen Allenrolfea occidentalis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-312_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-312 NON-STANDARDIZED ALLERGENIC Alder, White Pollen Alnus rhombifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-313_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-313 NON-STANDARDIZED ALLERGENIC Careless Weed Pollen Amaranthus palmerii INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. AMARANTHUS PALMERI POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-314_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-314 NON-STANDARDIZED ALLERGENIC Redroot Pigweed Pollen Amaranthus retroflexus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-315_27d42b75-737c-42aa-9ecf-25373fcd0fb0 49643-315 HUMAN PRESCRIPTION DRUG Short Ragweed Ambrosia artemisiifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19820101 BLA BLA103118 Allermed Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 1 g/10mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-316_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-316 NON-STANDARDIZED ALLERGENIC Western Ragweed Pollen Ambrosia psilostachia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-317_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-317 NON-STANDARDIZED ALLERGENIC Giant Ragweed Pollen Ambrosia trifida INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. AMBROSIA TRIFIDA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-318_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-318 HUMAN PRESCRIPTION DRUG Standardized Sweet Vernal Grass Anthoxanthum odoratum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102220 Allermed Laboratories, Inc. ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-319_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-319 NON-STANDARDIZED ALLERGENIC Wormwood Sage Pollen Artemisia absinthium INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-320_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-320 NON-STANDARDIZED ALLERGENIC Common Sage Pollen Artemisia tridentata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-321_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-321 NON-STANDARDIZED ALLERGENIC Mugwort Sage Pollen Artemisia vulgaris INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ARTEMISIA VULGARIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-322_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-322 NON-STANDARDIZED ALLERGENIC Cultivated Oat Pollen Avena sativa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. AVENA SATIVA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-323_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-323 NON-STANDARDIZED ALLERGENIC Bassia Pollen Bassia hyssopifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. BASSIA HYSSOPIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-324_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-324 NON-STANDARDIZED ALLERGENIC Sugar Beet Pollen Beta vulgaris INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. BETA VULGARIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-325_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-325 NON-STANDARDIZED ALLERGENIC Gray (White) Birch Pollen Betula populifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. BETULA POPULIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-326_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-326 NON-STANDARDIZED ALLERGENIC Grama grass Pollen Bouteloua spp. INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. BOUTELOUA GRACILIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-327_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-327 NON-STANDARDIZED ALLERGENIC Mustard Pollen Brassica campestris INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. BRASSICA RAPA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-328_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-328 NON-STANDARDIZED ALLERGENIC Smooth Brome Pollen Bromus inermis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. BROMUS INERMIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-329_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-329 NON-STANDARDIZED ALLERGENIC Cheat Grass Pollen Bromus secalinus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. BROMUS SECALINUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-330_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-330 NON-STANDARDIZED ALLERGENIC Bottlebrush Pollen Callistemon citrinus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CALLISTEMON CITRINUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-332_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-332 NON-STANDARDIZED ALLERGENIC Shagbark Hickory Pollen Carya ovata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CARYA OVATA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-334_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-334 NON-STANDARDIZED ALLERGENIC White Hickory Pollen Carya tomentosa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CARYA ALBA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-335_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-335 NON-STANDARDIZED ALLERGENIC Australian Pine Pollen Casuarina equisetifoli INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-336_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-336 NON-STANDARDIZED ALLERGENIC Hackberry Pollen Celtis occidentalis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-338_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-338 NON-STANDARDIZED ALLERGENIC Palo Verde Pollen Cercidium torreyana INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CERCIDIUM FLORIDUM SSP. FLORIDUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-339_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-339 NON-STANDARDIZED ALLERGENIC Lambs Quarters Pollen Chenopodium album INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CHENOPODIUM ALBUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-340_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-340 NON-STANDARDIZED ALLERGENIC Hazelnut Pollen Corylus americana INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CORYLUS AMERICANA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-341_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-341 NON-STANDARDIZED ALLERGENIC Cypress, Arizona Pollen Cupressus arizonica INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-342_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-342 HUMAN PRESCRIPTION DRUG Standardized Bermuda Grass CYNODON DACTYLON INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102214 Allermed Laboratories, Inc. CYNODON DACTYLON POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-343_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-343 HUMAN PRESCRIPTION DRUG Standardized Orchard Grass Dactylis glomerata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102217 Allermed Laboratories, Inc. DACTYLIS GLOMERATA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-344_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-344 NON-STANDARDIZED ALLERGENIC Silver Ragweed Pollen Dicoria canescens INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. DICORIA CANESCENS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-345_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-345 NON-STANDARDIZED ALLERGENIC Salt Grass Pollen Distichlis spicata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. DISTICHLIS SPICATA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-346_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-346 NON-STANDARDIZED ALLERGENIC Russian Olive Pollen Elaeagnus angustifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-347_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-347 NON-STANDARDIZED ALLERGENIC Eucalyptus Pollen Eucalyptus globulus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-348_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-348 NON-STANDARDIZED ALLERGENIC Winterfat Pollen Eurotia lanata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. KRASCHENINNIKOVIA LANATA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-349_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-349 NON-STANDARDIZED ALLERGENIC Beech Pollen Fagus grandifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-350_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-350 HUMAN PRESCRIPTION DRUG Standardized Meadow Fescue Grass Festuca elatior INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102216 Allermed Laboratories, Inc. FESTUCA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-351_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-351 NON-STANDARDIZED ALLERGENIC False Ragweed Pollen Ambrosia acanthicarpa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-352_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-352 NON-STANDARDIZED ALLERGENIC Canyon Ragweed Pollen Ambrosia ambrosioides INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. AMBROSIA AMBROSIOIDES POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-353_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-353 NON-STANDARDIZED ALLERGENIC Sandbur Ragweed Pollen Ambrosia bipinnatifida INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. AMBROSIA CHAMISSONIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-354_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-354 NON-STANDARDIZED ALLERGENIC Rabbitbush Pollen Ambrosia deltoides INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-355_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-355 NON-STANDARDIZED ALLERGENIC Desert Ragweed Pollen Ambrosia dumosa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. AMBROSIA DUMOSA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-356_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-356 NON-STANDARDIZED ALLERGENIC Slender Ragweed Pollen Ambrosia tenuifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. AMBROSIA TENUIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-357_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-357 NON-STANDARDIZED ALLERGENIC White Ash Pollen Fraxinus americana INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. FRAXINUS AMERICANA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-358_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-358 NON-STANDARDIZED ALLERGENIC Green Ash Pollen Fraxinus pennsylvanica INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. FRAXINUS PENNSYLVANICA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-359_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-359 NON-STANDARDIZED ALLERGENIC Arizona Ash Pollen Fraxinus velutina INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. FRAXINUS VELUTINA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-360_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-360 NON-STANDARDIZED ALLERGENIC Sunflower Pollen Helianthus annua INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. HELIANTHUS ANNUUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-361_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-361 NON-STANDARDIZED ALLERGENIC Velvet Grass Pollen Holcus lanatus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. HOLCUS LANATUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-362_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-362 NON-STANDARDIZED ALLERGENIC Burrobrush Pollen Hymenoclea salsola INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-363_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-363 NON-STANDARDIZED ALLERGENIC Poverty Weed Pollen Iva axillaris INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. IVA AXILLARIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-364_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-364 NON-STANDARDIZED ALLERGENIC Rough Marshelder Pollen Iva ciliata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-365_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-365 NON-STANDARDIZED ALLERGENIC Burweed Marshelder Pollen Iva xanthifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. IVA XANTHIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-366_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-366 NON-STANDARDIZED ALLERGENIC Black Walnut Pollen Juglans nigra INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. JUGLANS NIGRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-367_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-367 NON-STANDARDIZED ALLERGENIC English Walnut Pollen Juglans regia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. JUGLANS REGIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-368_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-368 NON-STANDARDIZED ALLERGENIC California Juniper Pollen Juniperus californica INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. JUNIPERUS CALIFORNICA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-369_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-369 NON-STANDARDIZED ALLERGENIC Western Juniper Pollen Juniperus occidentalis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-370_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-370 NON-STANDARDIZED ALLERGENIC Utah Juniper Pollen Juniperus osteosperma INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-371_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-371 NON-STANDARDIZED ALLERGENIC Mountain Cedar Pollen Juniperus sabinoides INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. JUNIPERUS ASHEI POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-372_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-372 NON-STANDARDIZED ALLERGENIC Rocky Mtn. Juniper Pollen Juniperus scopulorum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-373_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-373 NON-STANDARDIZED ALLERGENIC Red Cedar Pollen Juniperus virginiana INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-374_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-374 NON-STANDARDIZED ALLERGENIC Burning Bush Pollen Kochia scoparia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. KOCHIA SCOPARIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-375_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-375 NON-STANDARDIZED ALLERGENIC Koelers Grass Pollen Koeleria cristata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. KOELERIA MACRANTHA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-376_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-376 NON-STANDARDIZED ALLERGENIC Privet Pollen Ligustrum vulgare INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. LIGUSTRUM VULGARE POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-377_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-377 NON-STANDARDIZED ALLERGENIC Sweet Gum Pollen Liquidamber styraciflua INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-379_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-379 HUMAN PRESCRIPTION DRUG Standardized Perennial Rye Grass Lolium perenne INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102219 Allermed Laboratories, Inc. LOLIUM PERENNE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-380_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-380 NON-STANDARDIZED ALLERGENIC Melaleuca Pollen Melaleuca leucadendron INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-382_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-382 NON-STANDARDIZED ALLERGENIC White Mulbery Pollen Morus alba INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. MORUS ALBA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-383_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-383 NON-STANDARDIZED ALLERGENIC European Olive Pollen Olea europea INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. OLEA EUROPAEA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-384_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-384 NON-STANDARDIZED ALLERGENIC Bahia Grass Pollen Paspalum notatum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. PASPALUM NOTATUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-385_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-385 NON-STANDARDIZED ALLERGENIC Canary Grass Pollen Phalaris arundinaceae INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-386_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-386 HUMAN PRESCRIPTION DRUG Standardized Timothy Grass Phleum pratense INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102221 Allermed Laboratories, Inc. PHLEUM PRATENSE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-387_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-387 NON-STANDARDIZED ALLERGENIC Date Palm Pollen Phoenix dactylifera INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. PHOENIX DACTYLIFERA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-388_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-388 NON-STANDARDIZED ALLERGENIC Eastern White Pine Pollen Pinus strobus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. PINUS STROBUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-389_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-389 NON-STANDARDIZED ALLERGENIC English Plantain Pollen Plantago lanceolata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-391_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-391 NON-STANDARDIZED ALLERGENIC Eastern Sycamore Pollen Platanus occidentalis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-392_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-392 NON-STANDARDIZED ALLERGENIC Western Sycamore Pollen Platanus racemosa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. PLATANUS RACEMOSA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-393_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-393 HUMAN PRESCRIPTION DRUG Standardized Kentucky Blue (June) Grass Poa pratensis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102215 Allermed Laboratories, Inc. POA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-394_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-394 NON-STANDARDIZED ALLERGENIC White Poplar Pollen Populus alba INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. POPULUS ALBA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-395_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-395 NON-STANDARDIZED ALLERGENIC Eastern Cottonwood Pollen Populus deltoides INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. POPULUS DELTOIDES POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-396_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-396 NON-STANDARDIZED ALLERGENIC Fremont Cottonwood Pollen Populus fremontii INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. POPULUS FREMONTII POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-397_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-397 NON-STANDARDIZED ALLERGENIC Lombard Poplar Pollen Populus nigra INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. POPULUS NIGRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-398_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-398 NON-STANDARDIZED ALLERGENIC Aspen Pollen Populus tremuloides INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. POPULUS TREMULOIDES POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-399_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-399 NON-STANDARDIZED ALLERGENIC Black Cottonwood Pollen Populus trichocarpa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. POPULUS BALSAMIFERA SSP. TRICHOCARPA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-400_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-400 NON-STANDARDIZED ALLERGENIC Mesquite Pollen Prosopis juliflora INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. PROSOPIS JULIFLORA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-401_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-401 NON-STANDARDIZED ALLERGENIC Coast Live Oak Pollen Quercus agrifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-402_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-402 NON-STANDARDIZED ALLERGENIC White Oak Pollen Quercus alba INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. QUERCUS ALBA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-403_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-403 NON-STANDARDIZED ALLERGENIC California Scrub Oak Pollen Quercus dumosa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. QUERCUS DUMOSA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-404_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-404 NON-STANDARDIZED ALLERGENIC Gambels Oak Pollen Quercus gambelii INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. QUERCUS GAMBELII POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-405_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-405 NON-STANDARDIZED ALLERGENIC Sheep Sorrel Pollen Rumex acetosella INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. RUMEX ACETOSELLA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 49643-406_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-406 NON-STANDARDIZED ALLERGENIC Dock, Yellow Pollen Rumex crispus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. RUMEX CRISPUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-407_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-407 NON-STANDARDIZED ALLERGENIC Pussy Willow Pollen Salix discolor INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. SALIX DISCOLOR POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-408_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-408 NON-STANDARDIZED ALLERGENIC Arroyo Willow Pollen Salix lasiolepsis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. SALIX LASIOLEPIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-409_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-409 NON-STANDARDIZED ALLERGENIC Black Willow Pollen Salix nigra INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. SALIX NIGRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-410_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-410 NON-STANDARDIZED ALLERGENIC Russian Thistle Pollen Salsola kali INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. SALSOLA KALI POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-411_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-411 NON-STANDARDIZED ALLERGENIC Greasewood Pollen Sarcobatus vermiculatus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-412_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-412 NON-STANDARDIZED ALLERGENIC Pepper Tree Pollen Schinus molle INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. SCHINUS MOLLE POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-413_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-413 NON-STANDARDIZED ALLERGENIC Johnson Grass Pollen Sorghum halepense INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. SORGHUM HALEPENSE POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-414_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-414 NON-STANDARDIZED ALLERGENIC Alkali Blite Pollen Suaeda spp. INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. SUAEDA MOQUINII POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-415_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-415 NON-STANDARDIZED ALLERGENIC Salt Cedar Pollen Tamarix gallica INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. TAMARIX GALLICA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-416_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-416 NON-STANDARDIZED ALLERGENIC Dandelion Pollen Taraxacum officinale INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. TARAXACUM OFFICINALE POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-417_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-417 NON-STANDARDIZED ALLERGENIC American Elm Pollen Ulmus americana INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ULMUS AMERICANA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-419_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-419 NON-STANDARDIZED ALLERGENIC Chinese Elm Pollen Ulmus pumila INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ULMUS PUMILA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-420_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-420 NON-STANDARDIZED ALLERGENIC Cocklebur Pollen Xanthium commune INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-422_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-422 NON-STANDARDIZED ALLERGENIC Corn Pollen Pollen Zea mays INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ZEA MAYS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-423_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-423 NON-STANDARDIZED ALLERGENIC Nettle Pollen Urtica dioica INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. URTICA DIOICA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-434_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-434 NON-STANDARDIZED ALLERGENIC Red Maple Pollen Acer rubrum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ACER RUBRUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-435_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-435 NON-STANDARDIZED ALLERGENIC Red Alder Pollen Alnus rubra INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ALNUS RUBRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-436_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-436 NON-STANDARDIZED ALLERGENIC Tag Alder Pollen Alnus rugosa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ALNUS INCANA SSP. RUGOSA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-437_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-437 NON-STANDARDIZED ALLERGENIC Coast Sage Pollen Artemisia californica INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ARTEMISIA CALIFORNICA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-438_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-438 NON-STANDARDIZED ALLERGENIC Wing Scale Pollen Atriplex canescens INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ATRIPLEX CANESCENS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-439_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-439 NON-STANDARDIZED ALLERGENIC Shad Scale Pollen Atriplex confertifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ATRIPLEX CONFERTIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-440_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-440 NON-STANDARDIZED ALLERGENIC Lens Scale Pollen Atriplex lentiformis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-441_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-441 NON-STANDARDIZED ALLERGENIC Spring Birch Pollen Betula fontinalis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. BETULA OCCIDENTALIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-442_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-442 NON-STANDARDIZED ALLERGENIC Cherry Birch Pollen Betula lenta INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. BETULA LENTA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-443_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-443 NON-STANDARDIZED ALLERGENIC River/Red Birch Pollen Betula nigra INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. BETULA NIGRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-444_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-444 NON-STANDARDIZED ALLERGENIC Pecan Pollen Carya illinoinensis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. CARYA ILLINOINENSIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-446_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-446 NON-STANDARDIZED ALLERGENIC Calif. Black Walnut Pollen Juglans californica INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. JUGLANS CALIFORNICA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-447_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-447 NON-STANDARDIZED ALLERGENIC Red Mulberry Pollen Morus rubra INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. MORUS RUBRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-448_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-448 NON-STANDARDIZED ALLERGENIC Shortleaf Pine Pollen Pinus echinata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. PINUS ECHINATA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-449_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-449 NON-STANDARDIZED ALLERGENIC Yellow Pine Pollen Pinus ponderosa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. PINUS PONDEROSA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-450_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-450 NON-STANDARDIZED ALLERGENIC Red Oak Pollen Quercus rubra INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. QUERCUS RUBRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-451_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-451 NON-STANDARDIZED ALLERGENIC Black Oak Pollen Quercus velutina INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. QUERCUS VELUTINA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-452_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-452 NON-STANDARDIZED ALLERGENIC Hard Maple Pollen Acer saccharum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. ACER SACCHARUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-460_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-460 NON-STANDARDIZED ALLERGENIC Linden Pollen Tilia cordata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. TILIA CORDATA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-702_5664e19e-6019-4b8b-b2d0-c349910bcf07 49643-702 HUMAN PRESCRIPTION DRUG House Dust Mite, Dermatophagoides farinae House Dust Mite, Dermatophagoides farinae INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19861224 BLA BLA102212 Allermed Laboratories, Inc. DERMATOPHAGOIDES FARINAE 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-704_5664e19e-6019-4b8b-b2d0-c349910bcf07 49643-704 HUMAN PRESCRIPTION DRUG House Dust Mite, Dermatophagoides pteronyssinus House Dust Mite, Dermatophagoides pteronyssinus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19861224 BLA BLA102213 Allermed Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 49643-705_4794134f-8c59-4a48-bcb3-032bd384dc4e 49643-705 HUMAN PRESCRIPTION DRUG Cat Hair Cat Hair INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19920815 BLA BLA103473 Allermed Laboratories, Inc. FELIS CATUS HAIR 10000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] 49643-818_08a941f3-f8c0-410b-93e1-21278419e6c7 49643-818 NON-STANDARDIZED ALLERGENIC Glycerol-Saline Control Glycerol-Saline Diluent INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102212 Allermed Laboratories, Inc. GLYCERIN 53 g/100mL Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient] 49644-001_6e064dc2-ebd3-4c27-bb52-e05be8230a80 49644-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19700101 UNAPPROVED MEDICAL GAS Terry Supply Company OXYGEN 997 mL/L 49647-0001_0b8672eb-e9e3-45c9-bbbe-4a3ce11e3361 49647-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20090629 UNAPPROVED MEDICAL GAS Wenzl Drug, Inc OXYGEN 99 L/100L 49653-001_868c7ecc-78d8-4624-825c-33134521b1af 49653-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19800321 UNAPPROVED MEDICAL GAS Superior Welding Supply Co OXYGEN 990 mL/L 49653-002_90ad727c-671b-4bfa-af07-12137c29c636 49653-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19800321 UNAPPROVED MEDICAL GAS Superior Welding Supply Co NITROGEN 990 mL/L 49658-1001_061ba527-b2fb-472d-b5b3-1b7d598b1aff 49658-1001 HUMAN OTC DRUG HairQ PYRITHIONE ZINC SHAMPOO TOPICAL 20120523 UNAPPROVED DRUG OTHER Cresson PYRITHIONE ZINC .1 mL/100mL 49658-2001_c0cdfc33-66c5-4f25-b2be-73b28f989726 49658-2001 HUMAN OTC DRUG HairQ-Plus BIOTIN SHAMPOO TOPICAL 20120523 UNAPPROVED DRUG OTHER Cresson BIOTIN .06 mL/100mL 49658-3001_9a896b34-1e0f-459d-a29c-dc8c1792f268 49658-3001 HUMAN OTC DRUG HairQ PYRITHIONE ZINC SOLUTION TOPICAL 20120523 UNAPPROVED DRUG OTHER Cresson PYRITHIONE ZINC .1 mL/100mL 49658-4001_1c58c007-5cfa-45e4-921d-78c68ceecb28 49658-4001 HUMAN OTC DRUG HairQ-Plus BIOTIN SOLUTION TOPICAL 20120525 UNAPPROVED DRUG OTHER Cresson BIOTIN .06 mL/100mL 49663-001_0adfc1d0-b74c-11e2-9e96-0800200c9a66 49663-001 HUMAN PRESCRIPTION DRUG PROCYSBI Delayed-release Cysteamine Bitartrate CAPSULE, DELAYED RELEASE PELLETS ORAL 20130430 NDA NDA203389 RAPTOR THERAPEUTICS INC. CYSTEAMINE BITARTRATE 25 mg/1 Cystine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA] 49663-002_0adfc1d0-b74c-11e2-9e96-0800200c9a66 49663-002 HUMAN PRESCRIPTION DRUG PROCYSBI Delayed-release Cysteamine Bitartrate CAPSULE, DELAYED RELEASE PELLETS ORAL 20130430 NDA NDA203389 RAPTOR THERAPEUTICS INC. CYSTEAMINE BITARTRATE 75 mg/1 Cystine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA] 49668-001_3aba460a-1912-4794-a317-f477af962b40 49668-001 HUMAN OTC DRUG Carboxymethylcellulose sodium Carboxymethylcellulose sodium SOLUTION OPHTHALMIC 20091001 OTC MONOGRAPH FINAL part349 PROMED EXPORTS PRIVATE LIMITED CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL 49671-001_335effbd-b149-46cc-8007-1fe5ca499d70 49671-001 HUMAN OTC DRUG Wellness Products J-FLEX CAPSAICIN CREAM TOPICAL 20120412 OTC MONOGRAPH FINAL part348 Wellness Products CAPSAICIN .07 g/100g 49671-002_79db5d33-1d7f-4d2c-82cc-4e3acc36d455 49671-002 HUMAN OTC DRUG Wellness Products VictoRx CAPSAICIN CREAM TOPICAL 20120607 OTC MONOGRAPH FINAL part348 Wellness Products CAPSAICIN .07 g/100g 49672-100_f2f97861-043b-456a-89d1-505acc6246d1 49672-100 HUMAN OTC DRUG TECHNIblock ULTRA SUNSCREEN AVOBENZONE,OCTINOXATE,OXYBENZONE,PADIMATE LOTION TOPICAL 20100405 OTC MONOGRAPH FINAL part352 The Myles Group LLC AVOBENZONE; OCTINOXATE; OXYBENZONE; PADIMATE A .6; 6.3; 3.4; 5.1 mL/100mL; mL/100mL; mL/100mL; mL/100mL 49673-424_e6e278f4-f056-4aed-addd-76a970e281bb 49673-424 HUMAN PRESCRIPTION DRUG Indocyanine green Indocyanine green INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120701 ANDA ANDA040811 Novadaq Technologies Inc. INDOCYANINE GREEN 25 mg/1 49678-1005_86f17b54-e097-4373-9bc6-af13b92db10b 49678-1005 HUMAN OTC DRUG Dynamic Defence Concentrate Anti-Ageing Day SPF 15 OCTYL METHOXYCINNAMATE , OCTYL SALICYLATE, OXYBENZONE, AND AVOBENZONE CREAM TOPICAL 20100504 OTC MONOGRAPH FINAL part352 SARAH CHAPMAN LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL 49681-001_e5d5c331-5e03-9d75-5fcd-e43cb8d62c7e 49681-001 HUMAN OTC DRUG Vitale Sensitive Scalp Daily Scalp Healer Pyrithione Zinc CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part358 JF Labs, Inc. PYRITHIONE ZINC 250 mg/100g 49681-002_4666b310-b806-f603-4c2d-2e94761169bb 49681-002 HUMAN OTC DRUG Vitale Sensitive Scalp 12 in 1 Instant Relief Anti Dandruff Spray Salicylic Acid SPRAY TOPICAL 20091101 OTC MONOGRAPH FINAL part358 JF Labs, Inc. SALICYLIC ACID 15 mg/mL 49681-010_39cc039b-b58c-6925-31d9-9564f377201d 49681-010 HUMAN OTC DRUG Lusti Therapeutic Ice Analgesic Rub menthol, camphor GEL TOPICAL 20100324 OTC MONOGRAPH NOT FINAL part348 JF Labs, Inc. CAMPHOR (SYNTHETIC); MENTHOL .031; .015 g/g; g/g 49681-012_33f0793c-a486-39ca-dbda-e05f299cd840 49681-012 HUMAN OTC DRUG Lusti Profesional Vaporizing Rub Camphor,Eucalyptus Oil, Menthol OINTMENT TOPICAL 20100804 OTC MONOGRAPH FINAL part341 JF Labs, Inc. CAMPHOR, (SYNTHETIC); EUCALYPTUS OIL; MENTHOL .048; .012; .026 g/g; g/g; g/g 49685-928_5bf1a6d7-539b-4cbb-944f-3a1f39128d4f 49685-928 HUMAN PRESCRIPTION DRUG Qutenza capsaicin KIT 20100301 NDA NDA022395 NeurogesX, Inc. 49687-0000_cc7f834d-0ab4-4153-9966-4ef586e7e0f8 49687-0000 HUMAN OTC DRUG DAYMARK FAK-35 First Aid BENZALKONIUM CHLORIDE, BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, ISOPROPYL ALCOHOL KIT 20120419 OTC MONOGRAPH FINAL part333E CMC Group 49693-1001_280436c4-0260-4bc2-8c3d-d80d1f29b54f 49693-1001 HUMAN OTC DRUG Aspergillus Aspergillus niger var. niger LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo ASPERGILLUS NIGER VAR. NIGER 4 [hp_X]/10mL 49693-1101_66546d5c-a8b0-4894-817e-d82f399a97ac 49693-1101 HUMAN OTC DRUG Candida Candida parapsilosis LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo CANDIDA PARAPSILOSIS 4 [hp_X]/10mL 49693-1301_87f66e2e-ffef-400b-bf7a-cfff9d99e14a 49693-1301 HUMAN OTC DRUG Mucor Mucor racemosus LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo MUCOR RACEMOSUS 4 [hp_X]/10mL 49693-1306_bb64565a-3f29-4b46-be43-84373e03c67f 49693-1306 HUMAN OTC DRUG Mucor Mucor racemosus LIQUID OPHTHALMIC 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo MUCOR RACEMOSUS 5 [hp_X]/5mL 49693-1401_7537f2a7-b0ea-4b8e-8c24-690aaf1c34e5 49693-1401 HUMAN OTC DRUG Mucor/Aspergillus Mucor racemosus and Aspergillus niger var. niger LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo ASPERGILLUS NIGER VAR. NIGER; MUCOR RACEMOSUS 4; 4 [hp_X]/10mL; [hp_X]/10mL 49693-1501_55fe1ebe-5cee-4447-a6e0-faee948b59a9 49693-1501 HUMAN OTC DRUG Notatum Penicillium Chrysogenum Var. Chrysogenum LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 4 [hp_X]/10mL 49693-1601_96db674c-cd96-4555-912f-ec770413d1bd 49693-1601 HUMAN OTC DRUG Notatum-Quentans Penicillium chrysogenum var. chrysogenum and Penicillium glabrum LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM 4; 4 [hp_X]/10mL; [hp_X]/10mL 49693-1604_fecf48bb-b6bc-4185-88cf-95f1f6631be6 49693-1604 HUMAN OTC DRUG Notatum-Quentans Penicillium chrysogenum var. chrysogenum and Penicillium glabrum SUSPENSION/ DROPS NASAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM 4; 4 [hp_X]/10mL; [hp_X]/10mL 49693-1701_514a89fa-ddc3-4493-bc9d-c80e233f87d5 49693-1701 HUMAN OTC DRUG Quentans Penicillium glabrum LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo PENICILLIUM GLABRUM 4 [hp_X]/10mL 49693-1801_09feba2f-b6b5-458d-af19-e7ab0c84e93e 49693-1801 HUMAN OTC DRUG Roqueforti Penicillium roqueforti LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo PENICILLIUM ROQUEFORTI 4 [hp_X]/10mL 49693-2001_323bf388-43f1-42de-adc8-265ca164aa6f 49693-2001 HUMAN OTC DRUG Cereus Bacillus cereus LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo BACILLUS CEREUS 6 [hp_X]/5mL 49693-2101_7bb653a1-456e-4674-b00b-50aecd53aeb8 49693-2101 HUMAN OTC DRUG Firmus Bacillus firmus LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo BACILLUS FIRMUS 6 [hp_X]/5mL 49693-2201_e0374546-af46-43b5-babd-db2c9849786e 49693-2201 HUMAN OTC DRUG Mycobactin S Mycobacterium phlei LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo MYCOBACTERIUM PHLEI 6 [hp_X]/5mL 49693-2301_1b295707-cae6-4a8d-9d90-da81a54e3ab7 49693-2301 HUMAN OTC DRUG Subtilis Bacillus subtilis LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo BACILLUS SUBTILIS 6 [hp_X]/5mL 49696-622_5aeebd30-19fc-4633-b4ae-939d2a7fcfa9 49696-622 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19550101 UNAPPROVED MEDICAL GAS Oxygen Service Company, Inc OXYGEN 99 L/100L 49696-632_5aeebd30-19fc-4633-b4ae-939d2a7fcfa9 49696-632 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19550101 UNAPPROVED MEDICAL GAS Oxygen Service Company, Inc OXYGEN 99 L/100L 49698-100_8524c0a9-46b6-4297-bc47-c47ea6c647ed 49698-100 HUMAN OTC DRUG Asepso Gentle Antibacterial CHLOROXYLENOL SOAP TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333E CODAA Switzerland / Euro Sensations CHLOROXYLENOL 25 g/100g 49698-200_eaa1b501-31a4-4bb6-afdb-681fefdac9ac 49698-200 HUMAN OTC DRUG Asepso Sport Antibacterial CHLOROXYLENOL SOAP TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333E CODAA Switzerland / Euro Sensations CHLOROXYLENOL 25 g/100g 49698-300_d0a09d5e-9aac-4ce8-bede-812078612d31 49698-300 HUMAN OTC DRUG Asepso TRICLOSAN SOAP TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part333E CODAA Switzerland / Euero Sensation TRICLOSAN 25 g/100g 49701-2000_fc31e3f2-edb3-44f9-b55d-d54785703f9a 49701-2000 HUMAN OTC DRUG Antibacterial Hand Sanitizer Spray ALCOHOL SPRAY TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 The Webb Company ALCOHOL 62 mL/100mL 49701-3000_7664a7ae-1c09-498e-aaaa-4c00b2b96ead 49701-3000 HUMAN OTC DRUG Antibacterial Hand Sanitizer Gel ALCOHOL GEL TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 The Webb Company ALCOHOL 62 mL/100mL 49701-4000_926f0d23-a4f5-4d45-a364-e58bf5257b02 49701-4000 HUMAN OTC DRUG Citrus Scent Antibacterial Hand Wipe BENZALKONIUM CHLORIDE SWAB TOPICAL 20091124 OTC MONOGRAPH NOT FINAL part333 The Webb Company BENZALKONIUM CHLORIDE .1 1/1 49701-9000_65f7c57b-3787-4c7a-9399-a1f858045109 49701-9000 HUMAN OTC DRUG Webb Candy Peppermint Candy Cane Lip Balm LIPSTICK TOPICAL 20090911 OTC MONOGRAPH FINAL part352 Webb Candy OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 2; 3 g/100g; g/100g; g/100g 49701-9001_4ec7c880-0e07-411c-9add-312499ec11ed 49701-9001 HUMAN OTC DRUG Cherry Candy Cane Lip Balm Octinoxate, Oxybenzone, Octisalate LIPSTICK TOPICAL 20090911 OTC MONOGRAPH FINAL part352 Webb Candy OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 2; 3 g/100g; g/100g; g/100g 49702-202_5efe61ac-5961-468b-9c52-96d45b407b34 49702-202 HUMAN PRESCRIPTION DRUG COMBIVIR lamivudine and zidovudine TABLET, FILM COATED ORAL 20101019 NDA NDA020857 ViiV Healthcare Company LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49702-203_51f563a7-f624-4349-9cf4-b117ea35f1d2 49702-203 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 20101004 NDA NDA020564 ViiV Healthcare Company LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49702-204_51f563a7-f624-4349-9cf4-b117ea35f1d2 49702-204 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 20101004 NDA NDA020564 ViiV Healthcare Company LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49702-205_51f563a7-f624-4349-9cf4-b117ea35f1d2 49702-205 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine SOLUTION ORAL 20101004 NDA NDA020596 ViiV Healthcare Company LAMIVUDINE 10 mg/mL Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49702-206_51370fc6-ce4d-4272-b9d1-2564003ff5fd 49702-206 HUMAN PRESCRIPTION DRUG EPZICOM abacavir sulfate and lamivudine TABLET, FILM COATED ORAL 20101012 NDA NDA021652 ViiV Healthcare Company ABACAVIR SULFATE; LAMIVUDINE 600; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49702-207_0d5e1920-d3b3-430c-84be-2bceacae4c72 49702-207 HUMAN PRESCRIPTION DRUG LEXIVA fosamprenavir calcium TABLET, FILM COATED ORAL 20101004 NDA NDA021548 ViiV Healthcare Company FOSAMPRENAVIR CALCIUM 700 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA] 49702-208_0d5e1920-d3b3-430c-84be-2bceacae4c72 49702-208 HUMAN PRESCRIPTION DRUG LEXIVA fosamprenavir calcium SUSPENSION ORAL 20101004 NDA NDA022116 ViiV Healthcare Company FOSAMPRENAVIR CALCIUM 50 mg/mL HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA] 49702-209_2cd0cdcf-0946-45bf-9e48-4c48d72ba8f7 49702-209 HUMAN PRESCRIPTION DRUG RESCRIPTOR delavirdine mesylate TABLET ORAL 20101013 NDA NDA020705 ViiV Healthcare Company DELAVIRDINE MESYLATE 100 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] 49702-210_2cd0cdcf-0946-45bf-9e48-4c48d72ba8f7 49702-210 HUMAN PRESCRIPTION DRUG RESCRIPTOR delavirdine mesylate TABLET ORAL 20101013 20161231 NDA NDA020705 ViiV Healthcare Company DELAVIRDINE MESYLATE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] 49702-211_3838ce93-6bda-46cf-a235-cebcdb952b63 49702-211 HUMAN PRESCRIPTION DRUG RETROVIR zidovudine CAPSULE ORAL 20101028 NDA NDA019655 ViiV Healthcare Company ZIDOVUDINE 100 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49702-212_3838ce93-6bda-46cf-a235-cebcdb952b63 49702-212 HUMAN PRESCRIPTION DRUG RETROVIR zidovudine SYRUP ORAL 20101028 NDA NDA019910 ViiV Healthcare Company ZIDOVUDINE 10 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49702-213_377226a1-ee0c-4152-8234-67e8edb81b2e 49702-213 HUMAN PRESCRIPTION DRUG RETROVIR zidovudine INJECTION, SOLUTION INTRAVENOUS 20101104 NDA NDA019951 ViiV Healthcare Company ZIDOVUDINE 10 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49702-214_3838ce93-6bda-46cf-a235-cebcdb952b63 49702-214 HUMAN PRESCRIPTION DRUG RETROVIR zidovudine TABLET, FILM COATED ORAL 20101028 NDA NDA020518 ViiV Healthcare Company ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49702-215_23cec09c-ad2e-4c88-beeb-366bcb5e67a8 49702-215 HUMAN PRESCRIPTION DRUG SELZENTRY maraviroc TABLET, FILM COATED ORAL 20101013 20150131 NDA NDA022128 ViiV Healthcare Company MARAVIROC 150 mg/1 CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] 49702-216_23cec09c-ad2e-4c88-beeb-366bcb5e67a8 49702-216 HUMAN PRESCRIPTION DRUG SELZENTRY maraviroc TABLET, FILM COATED ORAL 20100901 20150331 NDA NDA022128 ViiV Healthcare Company MARAVIROC 300 mg/1 CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] 49702-217_dd05a81a-3a18-4a3b-949e-091bafa3d719 49702-217 HUMAN PRESCRIPTION DRUG TRIZIVIR abacavir sulfate, lamivudine, and zidovudine TABLET, FILM COATED ORAL 20101102 NDA NDA021205 ViiV Healthcare Company ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE 300; 150; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49702-221_5f369f8c-9d07-4043-ba3c-096f299f98a9 49702-221 HUMAN PRESCRIPTION DRUG ZIAGEN abacavir sulfate TABLET, FILM COATED ORAL 19981229 NDA NDA020977 ViiV Healthcare Company ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49702-222_5f369f8c-9d07-4043-ba3c-096f299f98a9 49702-222 HUMAN PRESCRIPTION DRUG ZIAGEN abacavir sulfate SOLUTION ORAL 19990128 NDA NDA020978 ViiV Healthcare Company ABACAVIR SULFATE 20 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49702-223_52cafd98-33e4-4457-8d41-1748bda02094 49702-223 HUMAN PRESCRIPTION DRUG SELZENTRY maraviroc TABLET, FILM COATED ORAL 20110516 NDA NDA022128 ViiV Healthcare Company MARAVIROC 150 mg/1 CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] 49702-224_52cafd98-33e4-4457-8d41-1748bda02094 49702-224 HUMAN PRESCRIPTION DRUG SELZENTRY maraviroc TABLET, FILM COATED ORAL 20110516 NDA NDA022128 ViiV Healthcare Company MARAVIROC 300 mg/1 CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] 49702-225_2cd0cdcf-0946-45bf-9e48-4c48d72ba8f7 49702-225 HUMAN PRESCRIPTION DRUG RESCRIPTOR delavirdine mesylate TABLET ORAL 20120411 NDA NDA020705 ViiV Healthcare Company DELAVIRDINE MESYLATE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] 49702-228_b9f1f0f5-6c4a-46f8-bc01-f20f52359dbd 49702-228 HUMAN PRESCRIPTION DRUG Tivicay dolutegravir sodium TABLET, FILM COATED ORAL 20130813 NDA NDA204790 ViiV Healthcare Company DOLUTEGRAVIR SODIUM 50 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] 49702-231_2d498835-3b28-4022-a81b-ab6f36d0d9bd 49702-231 HUMAN PRESCRIPTION DRUG Triumeq dolutegravir sodium, abacavir sulfate, lamivudine TABLET, FILM COATED ORAL 20140822 NDA NDA205551 ViiV Healthcare Company ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE 600; 50; 300 mg/1; mg/1; mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49708-101_b6efc493-20b9-4387-8106-7d353c0132c2 49708-101 HUMAN PRESCRIPTION DRUG FIBRICOR Fenofibric Acid TABLET ORAL 20090814 NDA NDA022418 Caraco Pharma, Inc. FENOFIBRIC ACID 35 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 49708-102_b6efc493-20b9-4387-8106-7d353c0132c2 49708-102 HUMAN PRESCRIPTION DRUG FIBRICOR Fenofibric Acid TABLET ORAL 20090814 NDA NDA022418 Caraco Pharma, Inc. FENOFIBRIC ACID 105 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 49708-145_235c0269-9156-4fcf-bfcf-daa84fab00de 49708-145 HUMAN PRESCRIPTION DRUG Bactrim sulfamethoxazole and Trimethoprim TABLET ORAL 20041101 NDA NDA017377 Caraco Pharma, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 49708-146_235c0269-9156-4fcf-bfcf-daa84fab00de 49708-146 HUMAN PRESCRIPTION DRUG Bactrim DS sulfamethoxazole and Trimethoprim TABLET ORAL 20041101 NDA NDA017377 Caraco Pharma, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 49708-153_6abd7007-d8cc-47c2-9877-f268f75fac4b 49708-153 HUMAN PRESCRIPTION DRUG Qualaquin Quinine Sulfate CAPSULE ORAL 20050812 NDA NDA021799 Caraco Pharma, Inc. QUININE SULFATE 324 mg/1 Antimalarial [EPC] 49708-419_7f5a021d-7474-4639-92d8-bbb761737c87 49708-419 HUMAN PRESCRIPTION DRUG Synalgos Aspirin, Caffeine, and Dihydrocodeine Bitartrate Capsules CAPSULE ORAL 20081230 NDA NDA011483 Caraco Pharma Inc. ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE 356.4; 30; 16 mg/1; mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 49708-521_3f2752c1-89c7-483d-a974-e47b75ffa259 49708-521 HUMAN PRESCRIPTION DRUG Flumadine flumadine TABLET ORAL 20090922 NDA NDA019649 Caraco Pharma, Inc. RIMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 49708-644_bfd3f76e-094c-4148-a74b-f10efed03685 49708-644 HUMAN PRESCRIPTION DRUG ELIXOPHYLLIN THEOPHYLLINE ANHYDROUS LIQUID ORAL 20091001 ANDA ANDA085186 Caraco Pharma, Inc. THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 49710-0001_93eef23c-1f71-4f81-a7ba-53d7ec72db1e 49710-0001 HUMAN OTC DRUG Optimal Diet Drops Fucus Vesiculosus, Cyanocobalamin, Glandula Suprarenalis Suis, Hepar Suis, L Carnitine, L Ornithine LIQUID ORAL 20130311 UNAPPROVED HOMEOPATHIC Optimal Labs LLC ANTIMONY TRISULFIDE; CYANOCOBALAMIN; FUCUS VESICULOSUS; LEVOCARNITINE; ORNITHINE; PANCRELIPASE; PORK LIVER; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA THYROID 8; 6; 2; 6; 6; 12; 6; 10; 6; 18; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49715-001_f1b5402d-6f4c-4d4b-b629-6bcc05a29034 49715-001 HUMAN OTC DRUG J and R Perfect Essence Beblesh Balm (40mL) TITANIUM DIOXIDE OCTINOXATE CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD OCTINOXATE; TITANIUM DIOXIDE 1.6; 3.6 mL/40mL; mL/40mL 49715-002_5373e6a1-1175-4dd8-ac66-e400f206f998 49715-002 HUMAN OTC DRUG SKIN 79 Super Plus Beblesh Balm SPF25 PA (40g) TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE 1.92; .78 g/40g; g/40g 49715-003_8f1fdbb9-349f-4e80-b69d-e5ca411bdc0b 49715-003 HUMAN OTC DRUG SKIN79 Super Plus Beblesh Balm Triple Functions SPF25 PA (5g) ZINC OXIDE, OCTISALATE, OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20091001 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE .15; .1; .24; .1 g/5g; g/5g; g/5g; g/5g 49715-004_9e62e349-eb9a-466b-9f27-f97e8f955515 49715-004 HUMAN OTC DRUG SKIN 79 The Prestige Beblesh Balm (5g) ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE .312; .19 g/5g; g/5g 49715-005_3ef970da-b81a-4e01-8022-f940d4e08f45 49715-005 HUMAN OTC DRUG SKIN 79 Super Plus Beblesh Balm Triple Functions SPF25 PA (40g) ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; .8; 1.92; .78 g/40g; g/40g; g/40g; g/40g 49715-006_b057c6df-a75b-49cd-bd5b-2b6191095d33 49715-006 HUMAN OTC DRUG SKIN 79 The Prestige Beblesh Balm (40g) ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE 2.5; 1.54 g/40g; g/40g 49715-007_961857f9-b7fd-43f6-aa44-7f120e2c41ed 49715-007 HUMAN OTC DRUG Super Plus Beblesh Balm Triple Functions SPF50 Plus PA 3Plus (40g) TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, AMILOXATE, ARBUTIN, ADENOSINE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD ADENOSINE; AMILOXATE; ARBUTIN; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .016; .4; .8; 2.8; 5.52; 1.569 g/40g; g/40g; g/40g; g/40g; g/40g; g/40g 49715-008_01c4d4e4-62a5-4901-8746-511eb2c8f02b 49715-008 HUMAN OTC DRUG The Prestige BB SPF25 PA 2Plus TITANIUM DIOXIDE, ZINC OXIDE, ARBUTIN, ADENOSINE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD ADENOSINE; ARBUTIN; TITANIUM DIOXIDE; ZINC OXIDE .016; .8; 2.5; 1.54 g/40g; g/40g; g/40g; g/40g 49715-009_e6cd817f-eb06-4d40-a2a6-9af3a9c028a4 49715-009 HUMAN OTC DRUG Sun Protect Beblesh Pact SPF30 PA 2Plus TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE 1.125; .75 g/15g; g/15g 49715-010_235c341a-03b1-4c37-bbff-46744c0c7142 49715-010 HUMAN OTC DRUG The Oriental Gold BB SPF25 PA 2Plus TITANIUM DIOXIDE, ZINC OXIDE, ARBUTIN, ADENOSINE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD ADENOSINE; ARBUTIN; TITANIUM DIOXIDE; ZINC OXIDE .016; .8; 2.5; 1.54 g/40g; g/40g; g/40g; g/40g 49715-011_48208893-0350-453a-aa5a-de1fa6673ec8 49715-011 HUMAN OTC DRUG Absolute Total BB SPF37 PA 3Plus TITANIUM DIOXIDE, ZINC OXIDE, ARBUTIN, ADENOSINE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD ADENOSINE; ARBUTIN; TITANIUM DIOXIDE; ZINC OXIDE .016; .8; 3.6; 2.52 g/40g; g/40g; g/40g; g/40g 49715-012_3763e28f-eda9-4ffa-88b2-3f0b3c74ac21 49715-012 HUMAN OTC DRUG Super Plus Beblesh Balm Triple Functions SPF25 PA 2Plus TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE 1.875; 1.25 g/25g; g/25g 49715-013_9177a2ba-206e-4c0a-b5b0-3a164508f7e3 49715-013 HUMAN OTC DRUG Homme Aqua Sun Block SPF50 Plus PA 2Plus OCTINOXATE, OCTISALATE, ENSULIZOLE, BEMOTRIZINOL, AVOBENZONE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD AVOBENZONE; BEMOTRIZINOL; ENSULIZOLE; OCTINOXATE; OCTISALATE 1.305; 1.305; 1.74; 3.26; 2.175 g/43.5g; g/43.5g; g/43.5g; g/43.5g; g/43.5g 49715-014_1fe70565-1417-45de-aa7e-691f916d1b12 49715-014 HUMAN OTC DRUG SuperPlus Beblesh Balm Triple Functions SPF25 PA 2Plus TITANIUM DIOXIDE, CTINOXATE, OCTISALATE, ARBUTIN, ZINC OXIDE, ADENOSINE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD ADENOSINE; ARBUTIN; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE .016; .8; 1.2; .8; 1.92; .768 g/40g; g/40g; g/40g; g/40g; g/40g; g/40g 49715-015_730b1887-7bb8-46bd-a496-9b494c34ad3a 49715-015 HUMAN OTC DRUG SuperPlus Beblesh Balm Gold SPF25 PA 2Plus TITANIUM DIOXIDE, ZINC OXIDE, ARBUTIN, ADENOSINE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD ADENOSINE; ARBUTIN; TITANIUM DIOXIDE; ZINC OXIDE .01; .5; 1.56; .96 g/25g; g/25g; g/25g; g/25g 49715-016_7c53be37-7056-41b6-b53f-93812fb73e68 49715-016 HUMAN OTC DRUG SuperPlus Beblesh Balm Gold SPF25 PA 2Plus TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ARBUTIN, ZINC OXIDE, ADENOSINE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD ADENOSINE; ARBUTIN; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE .016; .8; 1.2; .8; 1.92; .78 g/40g; g/40g; g/40g; g/40g; g/40g; g/40g 49715-017_8148764f-8aa6-4d78-87de-4ae5635e6355 49715-017 HUMAN OTC DRUG SuperPlus Beblesh Balm SPF25 PA 2Plus TITANIUM DIOXIDE, ZINC OXIDE, ARBUTIN, ADENOSINE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD ADENOSINE; ARBUTIN; TITANIUM DIOXIDE; ZINC OXIDE .01; .5; 1.56; .96 g/25g; g/25g; g/25g; g/25g 49715-018_17643708-053c-4aed-a3da-0abbf1d6e06d 49715-018 HUMAN OTC DRUG SuperPlus Beblesh Balm SPF25 PA 2Plus TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ARBUTIN, ZINC OXIDE, ADENOSINE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD ADENOSINE; ARBUTIN; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE .016; .8; 1.2; .8; 1.92; .78 g/40g; g/40g; g/40g; g/40g; g/40g; g/40g 49715-019_6b9a720d-96f7-4f70-8938-aea18203e254 49715-019 HUMAN OTC DRUG SKIN79 SNAIL NUTRITION BBCREAM Snail Secretion Filtrate Titanium Dioxide Zinc Oxide Arbutin Adenosine CREAM TOPICAL 20130301 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD ADENOSINE; ARBUTIN; SNAIL, UNSPECIFIED; TITANIUM DIOXIDE; ZINC OXIDE .016; .8; 18.05; 3.6; 2.52 g/40g; g/40g; g/40g; g/40g; g/40g 49721-0001_861c4866-fd4c-43b9-bf10-8574f70e1ec9 49721-0001 HUMAN OTC DRUG Liquid Detox Drops Citrus Limonum, Taraxacum Officinale, Uva Ursi, Berberis Vulgaris, Capsicum Annuum, Galium Aparine, Lobelia Inflata LIQUID ORAL 20130403 UNAPPROVED HOMEOPATHIC Weight Loss Products LLC ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CAPSICUM; GALIUM APARINE; LACTIC ACID; LEMON JUICE; LOBELIA INFLATA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PORK BRAIN; PORK HEART; PORK INTESTINE; PORK KIDNEY; PORK LIVER; SCHISANDRA CHINENSIS FRUIT; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA LUNG; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYROID; TARAXACUM OFFICINALE; TYLOPHORA INDICA LEAF 2; 3; 8; 3; 3; 8; 1; 3; 8; 8; 8; 8; 8; 8; 3; 3; 8; 8; 8; 8; 8; 2; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49721-0003_eded6ea9-4348-4c50-b219-2017393f20c7 49721-0003 HUMAN OTC DRUG RK Detox Drops not applicable LIQUID ORAL 20140825 UNAPPROVED HOMEOPATHIC Weight Loss Products, LLC ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CAPSICUM; GALIUM APARINE; LACTIC ACID, DL-; LEMON JUICE; LOBELIA INFLATA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PORK BRAIN; PORK HEART; PORK INTESTINE; PORK KIDNEY; PORK LIVER; SCHISANDRA CHINENSIS FRUIT; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA LUNG; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYROID; TARAXACUM OFFICINALE; TYLOPHORA INDICA WHOLE 2; 3; 8; 3; 3; 8; 1; 3; 8; 8; 8; 8; 8; 8; 3; 3; 8; 8; 8; 8; 8; 2; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 49725-926_f910e9d7-b443-4ad1-a88f-93bdfc26858c 49725-926 HUMAN OTC DRUG Antimicrobial Hand Sanitizing Lotion Mango Scented Ethyl Alcohol LOTION TOPICAL 20090928 OTC MONOGRAPH FINAL part333 HandsFree ALCOHOL 62 mL/100mL 49726-002_e62d6a94-6a67-4ac1-81d2-53e54aeabb8d 49726-002 HUMAN OTC DRUG Activive Fatigue Symptom Relief Alfalfa, Ambra Grisea, Anacardium Orientale, Argentum Nitricum, Aurum Metalicum, Avena Sativa, Caladium Seguinum, Calcarea Carbonica, Cocculus Indicus, Gelsemium Sempervirens, Ignatia Amara, Kali Phosphoricum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Phosphorus, Selenium Metallicum, Sepia, Silicea, Sulphur LIQUID ORAL 20100107 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. ALFALFA; AMBERGRIS; ANAMIRTA COCCULUS SEED; AVENA SATIVA FLOWERING TOP; DIEFFENBACHIA SEGUINE; GELSEMIUM SEMPERVIRENS ROOT; GOLD; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-003_894a7d3f-5e42-4326-af8d-017e607d0d77 49726-003 HUMAN OTC DRUG Respitrol Ammonium Carbonicum, Antimonim Arsenicosum, Antimonium Tartaricum, Arsenicum Album, Bromium, Carbo Vegetabilis, Chlorinum, Kali Carbonicum, Lobelia Inflata, Stannum Metallicum, Sulphuricum Acidum LIQUID ORAL 20100107 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. ACTIVATED CHARCOAL; AMMONIUM CARBONATE; ANTIMONY ARSENATE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BROMINE; CHLORINE; LOBELIA INFLATA; POTASSIUM CARBONATE; SULFURIC ACID; TIN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-004_b11f2284-72d1-4131-b9af-71e858343fc1 49726-004 HUMAN OTC DRUG Rhumatol Arthitis Symptom and Muscle Pain Relief Actaea spicata, Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Causticum, Cimicifuga racemosa, Formicum acidum, Hypericum perforatum, Ledum paulstre, Lithium carbonicum, Magnesia phosphorica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhododendron chrysanthum, Rhus toxicodendron, Ruta graveolens, Salicylicum acidum, Sepia, Zincum metallicum LIQUID ORAL 20100107 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. ACTAEA SPICATA ROOT; ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAUSTICUM; FORMIC ACID; HORSE CHESTNUT; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-005_305a01af-6b5a-4d3e-8b5b-3ca2ebdb0d64 49726-005 HUMAN OTC DRUG Candidol Candida Overgrowth Sympton Relief Abies Nigra, Antimonium Crudum, Asafoetida, Baptisia Tinctoria, Borax, Candida Albicans, Lachesis Mutus, Phosphoricum Acidum, Phytolacca Decandra, Pulsatilla, Sticta Pulmonaria, Sulphur, Thuja Occidentalis LIQUID ORAL 20100107 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife, Inc. ANTIMONY TRISULFIDE; ASAFETIDA; BAPTISIA TINCTORIA; CANDIDA ALBICANS; LACHESIS MUTA VENOM; LOBARIA PULMONARIA; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PICEA MARIANA RESIN; PULSATILLA VULGARIS; SODIUM BORATE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-006_5d34f00f-d109-4348-ba39-9bd7a2f040de 49726-006 HUMAN OTC DRUG Claritose Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Arundo Muritanica, Arum Triphylium, Euphrasia Officinalis, Naphthalinum, Natrum Muriaticum, Sabadilla, Wyethia Heleniodes LIQUID ORAL 20100107 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. AMBROSIA ARTEMISIIFOLIA; ARISAEMA TRIPHYLLUM ROOT; ARSENIC TRIOXIDE; ARUNDO PLINIANA ROOT; EUPHRASIA STRICTA; NAPHTHALENE; ONION; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; WYETHIA HELENIOIDES ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-008_66d31525-a47d-4080-8159-acefea3eae14 49726-008 HUMAN OTC DRUG Synaptol ADD/ADHD Symptom Relief Acconitum Ferox, Adrenalium, Apis Mellifica, Argentum Nitricum, Avena Sativa, Baptisia Tinctoria, Cochlearia Armoracia, Phosphorus, Medorrhinum, Sumbulus Moschatus, Scutellaria Laterfolia, Viola Odorata, Litsea Cubeba, Aesculus Hippocastanum, Mentha Piperita, Scleranthus Annuus LIQUID ORAL 20100301 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. ACONITUM FEROX ROOT; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA; EPINEPHRINE; FERULA SUMBUL ROOT; GONORRHEAL URETHRAL SECRETION HUMAN; HORSERADISH; LITSEA OIL; PEPPERMINT; PHOSPHORUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA; SILVER NITRATE; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-009_6376ded1-c9ca-4569-b648-9cdfdea5a8b2 49726-009 HUMAN OTC DRUG Viratrol Herpes Symptom Relief Apis Mellifica, Arsenicum Album, Borax, Capsicum Annuum, Graphites, Mentha piperita, Mezereum, Natrum muriaticum, Nux vomica, Petroleum, Ranunculus bulbosus LIQUID ORAL; TOPICAL 20100107 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; CAPSICUM; DAPHNE MEZEREUM BARK; GRAPHITE; PARAFFIN; PEPPERMINT; RANUNCULUS BULBOSUS; SODIUM BORATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-010_b929f97d-0367-4f45-bb88-d263c6cf6514 49726-010 HUMAN OTC DRUG Licenex Apis Mellifica, Carbolicum Acidum, Rosmarinus Officinalis SHAMPOO TOPICAL 20120404 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. APIS MELLIFERA; PHENOL; ROSMARINUS OFFICINALIS FLOWERING TOP 6; 6; 6 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL 49726-011_06e37494-56c2-484d-ad5a-cb179c0031a0 49726-011 HUMAN OTC DRUG Genitrex Apis Mellifica, Carbolicum Acidum, Rosmarinus Officinals SHAMPOO TOPICAL 20120404 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. APIS MELLIFERA; PHENOL; ROSMARINUS OFFICINALIS FLOWERING TOP 6; 6; 6 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL 49726-012_9ebe0e68-6a6d-4a2d-b5f8-c07758656644 49726-012 HUMAN OTC DRUG Painazol Pain Relief Actaea Spicata, Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Bryonia Alba, Calcarea Carbonica, Calcarea Fluorica, Causticum, Cimicifuga Racemosa, Formicum Acidum, Hypericum Perforatum, Ledum Paulstre, Lithium Carbonicum, Magnesia Phosphorica, Phosphorus, Phytolacca Decandra, Pulsatilla, Rhododendron Chrysanthum, Rhus Toxicodendron, Ruta Graveolens, Salicylicum Acidum, Sepia, Sulphur, Zincum Metallicum LIQUID ORAL; TOPICAL 20100520 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife ACTAEA SPICATA ROOT; AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAUSTICUM; FORMIC ACID; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; SULFUR; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-015_461f17ff-908b-463b-8f12-ed6370a579c3 49726-015 HUMAN OTC DRUG Neuroveen Neuropathy Symptom Relief Acontium Napellus, Agaricus Muscarius, Baryta Muriatica, Calendula Officinalis, Carbo Vegetabilis, Carduus Marianus, Chamomilla, Dulcamara, Glonoinum, Hamamelis Virginiana, Lycopersicum Esculentum, Magnesia Phosphorica, Phosphorus, Plumbum Metallicum, Rhus Toxicondendron, Secale Cornutum LIQUID ORAL; TOPICAL 20100914 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. ACONITUM NAPELLUS; ACTIVATED CHARCOAL; AMANITA MUSCARIA VAR. MUSCARIA; BARIUM CHLORIDE DIHYDRATE; CALENDULA OFFICINALIS FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LEAD; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; NITROGLYCERIN; PHOSPHORUS; SILYBUM MARIANUM SEED; SOLANUM DULCAMARA TOP; TOMATO; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-016_cdd08339-828d-47bc-8c58-b72d1f17b290 49726-016 HUMAN OTC DRUG Premensa PMS Symptom Relief Apis Mellifica, Chamomilla, Cimicifuga Racemosa, Cyclamen Europaeum, Helonias Dioca, Ignatia Amara, Lac Caninum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Platinum Metallicum, Sepia LIQUID ORAL 20110221 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. APIS MELLIFERA; BLACK COHOSH; CANIS LUPUS FAMILIARIS MILK; CHAMAELIRIUM LUTEUM ROOT; CHAMOMILE; CYCLAMEN PURPURASCENS TUBER; LYCOPODIUM CLAVATUM SPORE; PLATINUM; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-017_ae3afe80-47e9-4a37-8e87-c4ad3ff440df 49726-017 HUMAN OTC DRUG Honey Dont Cough Aconitum napellus, Bromium, Coccus Cacti, Corallium Rubrum, Cuprum Metallicum, Drosera Rotundifolia, Hepar Sulphuris Calcareum, Iodium, Mephitis Mephitica, Spongia Tosta SYRUP ORAL 20110314 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a Hello Life Inc. ACONITUM NAPELLUS; BROMINE; CALCIUM SULFIDE; COPPER; CORALLIUM RUBRUM EXOSKELETON; DROSERA ROTUNDIFOLIA; IODINE; MEPHITIS MEPHITIS ANAL GLAND FLUID; PROTORTONIA CACTI; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL 49726-018_a04de805-05b2-4eaa-9b53-47db9c4eed79 49726-018 HUMAN OTC DRUG Anxietin Anxiety Symptom Relief Aconitum napellus, alfalfa, argentum nitricum, aresenicum album, aurum metallicum, baryta carbonica, calcarea phosphorica, Chamomilla, kali phosphoricum, kali arsenicosum, Natrum phosphoricum, Staphysagria, Phosphorus, Stramonium, Ignatia amara, Muriaticum acidum, Gelsemium sempervirens, Passiflora incarnata, Glonoinum, Humulus lupulus, Avena Sativa LIQUID ORAL 20110401 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a Hello Life Inc. ACONITUM NAPELLUS; ALFALFA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; CHAMOMILE; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; GOLD; HOPS; HYDROCHLORIC ACID; NITROGLYCERIN; PASSIFLORA INCARNATA FLOWER; PHOSPHORUS; POTASSIUM ARSENITE ANHYDROUS; POTASSIUM PHOSPHATE, DIBASIC; SILVER NITRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS IGNATII SEED; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-019_fd0f9fa8-88b1-4343-947b-2270b7178306 49726-019 HUMAN OTC DRUG Stressivin Stress Relief Aconitum napellus, Hypericum perforatum, Apis mellifica, Arsenicum album, Arnica montana, Calendula officinalis, Ferrum phosphoricum, Histaminum hydrochloricum, Ignatia amara, Belladonna, Bellis perennis, Chamomilla, Bryonia, Passiflora incarnata, Sulphur, Symphytum officinale, Veratrum album, Cistus canadensis, Clematis erecta, Phosphorus, Impatiens glandulifera, flos, Prunus cerasifera, flos, Ornithogalum umbellatum, flos, Rhus toxicodendron LIQUID ORAL 20111107 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS RECTA FLOWERING TOP; COMFREY ROOT; FERRUM PHOSPHORICUM; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWER; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; STRYCHNOS IGNATII SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-020_603b5c08-41ad-4c0f-94f5-6268cef814e9 49726-020 HUMAN OTC DRUG Seretin Mild Depression Relief Anacardium Orientale, Avena Sativa, Aurum Metallicum, Calcarea Carbonica, Cimicifuga Racemosa, Cinchona Officinalis, Hypericum Perforatum, Ignatia Amara, Kali Bromatum, Natrum Carbonicum, Natrum Sulphuricum, Phosphoricum Acidum, Phosphorus, Pulsatilla, Sepia, Tabacum LIQUID ORAL 20110905 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. AVENA SATIVA FLOWERING TOP; BLACK COHOSH; CINCHONA OFFICINALIS BARK; GOLD; HYPERICUM PERFORATUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM BROMIDE; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS IGNATII SEED; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-021_243a746b-4a22-480b-be3b-46f134a9d4ea 49726-021 HUMAN OTC DRUG Compulsin OCD Symptom Relief Arsenicum Album, Aresnicum Iodatum, Calcarea Carbonica, Coffea Cruda, Iodum, Mancinella, Physostigma, Silicea LIQUID ORAL 20110905 20150601 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. ARABICA COFFEE BEAN; ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYSOSTIGMA VENENOSUM SEED; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-022_9166e702-61d3-44de-96c0-077b343b8984 49726-022 HUMAN OTC DRUG Restulex Restless Leg Symptom Relief Arsenicum album, Bufo rana, Causticum, Chamomilla, Crotalus horridus, Digitalis purpurea, Lachesis mutus, Lilium tigrinum, Pulsatilla, Rhus toxicodendron, Sulphur, Tarentula hispana, Viscum album, Zincum metallicum LIQUID ORAL; TOPICAL 20111109 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. ARSENIC TRIOXIDE; BUFO BUFO CUTANEOUS GLAND; CAUSTICUM; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM FLOWERING TOP; LYCOSA TARANTULA; MATRICARIA RECUTITA; PULSATILLA VULGARIS; SULFUR; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-023_479bad72-5e8d-4c68-8434-f10960f3782d 49726-023 HUMAN OTC DRUG Goutinex Gout Symptom Relief Actaea Spicata, Ammonium Phosphoricum, Belladonna, Colchicum Autumnale, Formicum Acidum, Fraxinus Excelsior, Ledum Palustre, Natrum Carbonicum, Nux Vomica, Phytolacca Decandra, Rhododendron Chrysanthum, Salicylicum Acidum, Urtica Urens LIQUID ORAL 20111109 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. ACTAEA SPICATA ROOT; AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; FRAXINUS EXCELSIOR LEAF; LEDUM PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; SALICYLIC ACID; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-024_85f1b71a-6079-427f-80ad-2814c3dd80d8 49726-024 HUMAN OTC DRUG Vertaway Amyl Nitrosum, Argentum Nitricum, Bryonia, Calendula Officinalis, Cocculus Indicus, Glonoinum, Lac Defloratum, Nux Vomica TABLET, ORALLY DISINTEGRATING ORAL 20121128 UNAPPROVED HOMEOPATHIC HelloLife, Inc. AMYL NITRITE; ANAMIRTA COCCULUS SEED; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; KEROSENE; NITROGLYCERIN; SILVER NITRATE; SKIM MILK; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA THYROID; THERIDION CURASSAVICUM; TOBACCO LEAF; WATER 6; 6; 10; 6; 6; 6; 6; 6; 6; 6; 6; 30; 6; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 49726-025_f34ef107-fcf5-44fc-93f5-ca90933c9cf3 49726-025 HUMAN OTC DRUG Thyroveev Antimonium crudum, Antimonium iodatum, Aqua Marina, Argentum iodatum, Badiaga, Bromium, Calcarea Carbonica, Calcarea Iodata, Cobaltum nitricum, Ferrum iodatum, Fucus, Gelsemium, Gentianella amarella flos, Hydrastis, Ignatia, Iodium, Kali iodatum, Lapis, Natrum bromatum, Natrum muriaticum, Parathormonum, Phosphoricum acidum, Rosmarinus, Sulphur iodatum, Thyroidinum LIQUID ORAL 20120815 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife ANTIMONY TRIIODIDE; ANTIMONY TRISULFIDE; BROMINE; CALCIUM HEXAFLUOROSILICATE; CALCIUM IODIDE; COBALTOUS NITRATE HEXAHYDRATE; FERROUS IODIDE; FUCUS VESICULOSUS; GELSEMIUM SEMPERVIRENS ROOT; GENTIANELLA AMARELLA FLOWER; GOLDENSEAL; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PARATHYROID HORMONE; PHOSPHORIC ACID; POTASSIUM IODIDE; ROSMARINUS OFFICINALIS FLOWERING TOP; SILVER IODIDE; SODIUM BROMIDE; SODIUM CHLORIDE; SPONGILLA LACUSTRIS; STRYCHNOS IGNATII SEED; SULFUR IODIDE; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-026_bf197673-1c28-4355-8e4d-c43cf10a1a26 49726-026 HUMAN OTC DRUG Insomulex Aesculus hipp, flos, Ambra, Arsenicum alb, Avena, Baryta carb, Camphora, Cinchona, Cocculus, Coffea cruda, Cypripedium, Gelsemium, Hyoscyamus, Ignatia, Kali brom, Kali phos, Mag carb, Muriaticum ac, Nat phos, Passiflora, Scutellaria, Sulphur, Valeriana, Zinc met LIQUID ORAL 20120815 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife AESCULUS HIPPOCASTANUM FLOWER; AMBERGRIS; ANAMIRTA COCCULUS SEED; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYDROCHLORIC ACID; HYOSCYAMUS NIGER; MAGNESIUM CARBONATE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM BROMIDE; POTASSIUM PHOSPHATE, DIBASIC; SCUTELLARIA LATERIFLORA; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS IGNATII SEED; SULFUR; VALERIAN; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-027_faf6f8dd-ec4e-49f8-81a8-ba4468dcdc73 49726-027 HUMAN OTC DRUG Diet Defense Abies canadensis, Anacardium orientale, Argentum metallicum, Adrenocorticotrophin, Hypothalamus, Ignatia amara, Lycopodium clavatum, Natrum phosphoricum, Phosphorus, Pituitarum posterium, Sabadilla, Staphysagria, Sulphur, Thyroidinum, Veratrum album LIQUID ORAL 20111024 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. BOS TAURUS HYPOTHALAMUS; CORTICOTROPIN; DELPHINIUM STAPHISAGRIA SEED; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SCHOENOCAULON OFFICINALE SEED; SEMECARPUS ANACARDIUM JUICE; SILVER; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS IGNATII SEED; SULFUR; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED; TSUGA CANADENSIS BARK; VERATRUM ALBUM ROOT 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1 [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL 49726-028_fab979a1-2e65-4662-a4fe-73d251b97f5d 49726-028 HUMAN OTC DRUG Synaptol Aconitum ferox, adrenallnum, aesculus hippocastanum, apis mellifica, argentum nitricum, avena sativa, baptisia tinctoria, cochlearia armoracia, phosphorus, scleranthus annuus, scutellaria lateriflora, sumbul, viola odorata LIQUID ORAL 20120831 UNAPPROVED HOMEOPATHIC IONX Holdings d/b/a HelloLife Inc. ACONITUM FEROX ROOT; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; EPINEPHRINE; FERULA SUMBUL ROOT; HORSERADISH; PHOSPHORUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA; SILVER NITRATE; VIOLA ODORATA 100; 100; 100; 100; 100; 100; 100; 100; 100; 100; 100; 100; 100 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-029_04f03c53-4ca9-481c-a594-e918fa785928 49726-029 HUMAN OTC DRUG Licenex Agaricus musc, Bovista, Muriaticum Ac, Pix liquida, Staphysag, Sulphur, Anacardium or, Apis mel, Causticum, Graphites, Oleander, Quassia, Rhus tox SHAMPOO TOPICAL 20130501 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; APIS MELLIFERA; CAUSTICUM; DELPHINIUM STAPHISAGRIA SEED; GRAPHITE; HYDROCHLORIC ACID; LYCOPERDON UTRIFORME FRUITING BODY; NERIUM OLEANDER LEAF; PINE TAR; QUASSIA AMARA WOOD; SEMECARPUS ANACARDIUM JUICE; SULFUR; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 8; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL 49726-030_2f8701e2-11f7-4cf2-a0ef-182f48d03aaf 49726-030 HUMAN OTC DRUG Genitrex Agaricus musc, Bovista, Muriaticum Ac, Pix liquida, Staphysag, Sulphur, Anacardium or, Apis mel, Causticum, Graphites, Oleander, Rhus tox SHAMPOO TOPICAL 20130204 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife LLC AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; APIS MELLIFERA; CAUSTICUM; DELPHINIUM STAPHISAGRIA SEED; GRAPHITE; HYDROCHLORIC ACID; LYCOPERDON UTRIFORME FRUITING BODY; NERIUM OLEANDER LEAF; PINE TAR; SEMECARPUS ANACARDIUM JUICE; SULFUR; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 8; 6; 6; 6; 6; 6; 6; 6 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL 49726-031_54ebbb95-e5ec-4f46-9c1c-4bf40f4e1d18 49726-031 HUMAN OTC DRUG MoodBrite anacardium orientale, larix decidua, flos, aurum metallicum, avena sativa, calcarea carbonica, cinchona officinalis, hypericum perforatum, kali bromatum, natrum sulphuricum, tabacum, ignatia amara, pulsatilla, sepia, sinapis arvensis, flos, cimicifuga racemosa, natrum carbonicum, phosphoricum acidum, phosphorus, carpinus betulus, flos LIQUID ORAL 20130308 UNAPPROVED HOMEOPATHIC Ionx d/b/a HelloLife, LLC AVENA SATIVA FLOWERING TOP; BLACK COHOSH; CARPINUS BETULUS FLOWERING TOP; CINCHONA OFFICINALIS BARK; GOLD; HYPERICUM PERFORATUM; LARIX DECIDUA FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM BROMIDE; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS IGNATII SEED; TOBACCO LEAF 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1 [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL 49726-032_d1a1d3b7-4044-4113-bf0d-7ebd1360f098 49726-032 HUMAN OTC DRUG Seretin Anacard or, Avena, Aur met, Calc Carb, Carpinis betelus, flos, Cimicifuga, Cinchona, Hypericum, Ignatia, Kali brom, Larix, flos, Nat carb, Nat sulphuricum, Phosphoricum ac, Phosphorus, Pulsatilla, Sinapis arv, flos, Sepia, Tabacum. LIQUID ORAL 20130304 UNAPPROVED HOMEOPATHIC Ionx d/b/a HelloLife, LLC AVENA SATIVA FLOWERING TOP; BLACK COHOSH; CARPINUS BETULUS FLOWERING TOP; CINCHONA OFFICINALIS BARK; GOLD; HYPERICUM PERFORATUM; LARIX DECIDUA FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM BROMIDE; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS IGNATII SEED; TOBACCO LEAF 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1 [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL 49726-033_065f538f-92c6-4f30-b1cb-1597e8a4eaa0 49726-033 HUMAN OTC DRUG Painazol Shingles Symptom Relief Cream Cedron, Mezereum, Phytolacca, Sempervivum, Croton, Mentha pip, Rhus tox, Dulcamara, Ranunc bulb, Grindelia, Salicylicum ac CREAM TOPICAL 20130805 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; GRINDELIA HIRSUTULA FLOWERING TOP; MENTHA PIPERITA; PHYTOLACCA AMERICANA ROOT; RANUNCULUS BULBOSUS; SALICYLIC ACID; SEMPERVIVUM TECTORUM LEAF; SIMABA CEDRON SEED; SOLANUM DULCAMARA TOP; TOXICODENDRON PUBESCENS LEAF 3; 1; 1; 1; 1; 3; 3; 2; 3; 2; 3 [hp_X]/128g; [hp_X]/128g; [hp_X]/128g; [hp_X]/128g; [hp_X]/128g; [hp_X]/128g; [hp_X]/128g; [hp_X]/128g; [hp_C]/128g; [hp_X]/128g; [hp_X]/128g 49726-034_70c9d5ef-2adb-428b-94ad-807856f58c63 49726-034 HUMAN OTC DRUG Compulsin arsenicum album, arsenicum iodatum, calcarea carbonica, coffea cruda, iodium, ulmus procera, flos, mancinella, physostigma venenosum, silicea LIQUID ORAL 20130925 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. ARABICA COFFEE BEAN; ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYSOSTIGMA VENENOSUM SEED; SILICON DIOXIDE; ULMUS PROCERA FLOWERING TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49726-035_4778568f-221f-443d-871a-1741141bc075 49726-035 HUMAN OTC DRUG Painazol Pain Relief Aconitum nap, Actaea, Aesculus hipp, Cimicifuga, Gnaphalium poly, Lilium, Lycopersicum, Oxalicum ac, Arnica, Bellis, Bryonia, Salicylicum ac, Colocynthis, Iris vers, Mag phos, Ruta, Stellaria med, Hypericum GEL TOPICAL 20131024 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. ACONITUM NAPELLUS; ACTAEA SPICATA ROOT; ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; HORSE CHESTNUT; HYPERICUM PERFORATUM; IRIS VERSICOLOR ROOT; LILIUM LANCIFOLIUM WHOLE FLOWERING; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SOLANUM LYCOPERSICUM; STELLARIA MEDIA 5; 5; 5; 5; 5; 5; 5; 5; 5; 5; 5; 8; 6; 5; 5; 5; 5; 5 [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g 49726-036_7da83896-9546-46d6-95c1-9b2534a91eb8 49726-036 HUMAN OTC DRUG Insomulex Aesculus hipp, flos, Ambra, Avena, Baryta carb, Camphora, Cinchona, Cocculus, Coffea cruda, Cypripedium, Gelsemium, Hyoscyamus, Ignatia, Kali brom, Kali phos, Mag carb, Muriaticum ac, Nat phos, Passiflora, Pulsatilla, Scutellaria, Sulphur, Valeriana, Zinc met LIQUID ORAL 20131125 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife AMBERGRIS; ANAMIRTA COCCULUS SEED; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HORSE CHESTNUT; HYDROCHLORIC ACID; HYOSCYAMUS NIGER; MAGNESIUM CARBONATE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM BROMIDE; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS IGNATII SEED; SULFUR; VALERIAN; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 49730-111_56b49a42-bdf8-4582-8643-fe8c370d509e 49730-111 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal System Nitroglycerin PATCH TRANSDERMAL 19981030 ANDA ANDA089884 Hercon Laboratories Corporation NITROGLYCERIN .2 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 49730-112_56b49a42-bdf8-4582-8643-fe8c370d509e 49730-112 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal System Nitroglycerin PATCH TRANSDERMAL 19981030 ANDA ANDA089885 Hercon Laboratories Corporation NITROGLYCERIN .4 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 49730-113_56b49a42-bdf8-4582-8643-fe8c370d509e 49730-113 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal System Nitroglycerin PATCH TRANSDERMAL 19981030 ANDA ANDA089886 Hercon Laboratories Corporation NITROGLYCERIN .6 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 49738-001_98d48ec8-ab28-4bfb-b3a4-497fa90bb0f9 49738-001 HUMAN OTC DRUG Smart Sense Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140218 ANDA ANDA075153 Kmart Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 49738-002_1614daaf-d1a5-4727-a3fa-0b9557f89e4a 49738-002 HUMAN OTC DRUG smart sense enema Saline ENEMA RECTAL 20111006 OTC MONOGRAPH NOT FINAL part334 Kmart Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 49738-005_6250defd-3f63-4af0-abf4-a48af006961d 49738-005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 Kmart Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 49738-010_dfa9a9e0-9871-4a39-9336-f83ef7a72bce 49738-010 HUMAN OTC DRUG pain relief Acetaminophen TABLET, COATED ORAL 20050309 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 500 mg/1 49738-013_4b0cb030-9405-4468-9c4a-e4d99757e5dc 49738-013 HUMAN OTC DRUG Smart Sense allergy and congestion relief indoor and outdoor allergies Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20130510 ANDA ANDA076050 Kmart Corporation LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 49738-015_b3c00e3e-a55e-402b-844e-8802df55e533 49738-015 HUMAN OTC DRUG IMAGE ESSENTIALS ANTIBACTERIAL HAND MANDARIN AND GRAPEFRUIT TRICLOSAN LIQUID TOPICAL 20141123 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN 1.5 mg/mL 49738-022_ddd67c7a-1762-4630-b202-9b69c39dfb1f 49738-022 HUMAN OTC DRUG smart sense acid reducer Cimetidine TABLET ORAL 20000106 ANDA ANDA075285 Kmart Corporation CIMETIDINE 200 mg/1 49738-027_3f5bbd33-82aa-4144-a573-9a5c31475029 49738-027 HUMAN OTC DRUG smart sense allergy Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20100827 ANDA ANDA077958 Kmart Corporation KETOTIFEN FUMARATE .25 mg/mL 49738-029_51b0d0d8-e379-434f-96be-31e1417a4959 49738-029 HUMAN OTC DRUG smart sense nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20110222 ANDA ANDA076775 Kmart Corporation NICOTINE 2 mg/1 49738-041_c84f1f4c-6208-42c5-92bd-937797b0d4f9 49738-041 HUMAN OTC DRUG smart sense nighttime acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090709 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 49738-046_04e0f6fc-40e0-40ca-be30-2abadff07445 49738-046 HUMAN OTC DRUG Smart Sense Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20090805 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 500 mg/1 49738-047_17b712db-4d4a-4c18-9df8-d491ff38d94e 49738-047 HUMAN OTC DRUG smart sense acid reducer Ranitidine TABLET ORAL 20101124 ANDA ANDA078653 Kmart Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 49738-050_7d0cc3a7-5ebf-4381-92c6-9d7eee6ee0cf 49738-050 HUMAN OTC DRUG Povidone Iodine povidone-iodine SOLUTION TOPICAL 20060913 OTC MONOGRAPH NOT FINAL part333A Kmart Corporation POVIDONE-IODINE .1 mg/mL 49738-054_34086c00-3796-4ebf-b7cc-bed4de186a38 49738-054 HUMAN OTC DRUG smart sense 12 hour decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110314 ANDA ANDA075153 Kmart Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 49738-057_1bd6bce7-f370-4f27-b5cb-ddc8070da340 49738-057 HUMAN OTC DRUG smart sense ibuprofen infants ibuprofen SUSPENSION ORAL 20100701 ANDA ANDA075217 Kmart Corporation IBUPROFEN 50 mg/1.25mL 49738-061_f16e266f-cd94-461c-ad3d-77bde3d626fb 49738-061 HUMAN OTC DRUG image essentials tioconazole treatment Tioconazole OINTMENT VAGINAL 20141226 ANDA ANDA075915 Kmart Corporation TIOCONAZOLE 6.5 g/100g 49738-062_b88c45b9-e359-44e6-bc95-7a8176248f9d 49738-062 HUMAN OTC DRUG Motion Sickness Relief Less Drowsy Meclizine HCl TABLET ORAL 20140228 OTC MONOGRAPH FINAL part336 SMART SENSE (Kmart) MECLIZINE HYDROCHLORIDE 25 mg/1 49738-063_c92ddbe6-7689-40f0-a3e4-4d1306a4a10d 49738-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 20090413 OTC MONOGRAPH FINAL part346 Kmart Corporation FERRIC OXIDE RED; ZINC OXIDE .8; .8 kg/100L; kg/100L 49738-065_203ca4a5-f738-4b92-aa64-e9f1a2008a65 49738-065 HUMAN OTC DRUG smart sense nasal extra moisturizing Oxymetazoline HCl SPRAY NASAL 20101112 OTC MONOGRAPH FINAL part341 Kmart Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 49738-067_490d0e5a-2d51-4984-b5ba-eab598646bcc 49738-067 HUMAN OTC DRUG smart sense triple antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20100927 OTC MONOGRAPH FINAL part333B Kmart Corporation BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 49738-072_07cd81cf-8091-4c98-9ce1-a1d992439801 49738-072 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20010329 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 49738-074_393497ef-f852-407a-bb80-330879c55017 49738-074 HUMAN OTC DRUG Smart Sense ibuprofen Ibuprofen TABLET, COATED ORAL 20100621 ANDA ANDA077349 Kmart Corporation IBUPROFEN 200 mg/1 49738-077_3dbe201b-9814-493a-9c6a-b8cbdd5293d0 49738-077 HUMAN OTC DRUG Aspirin Low Dose Enteric Coated Aspirin TABLET ORAL 20130331 OTC MONOGRAPH FINAL part343 SMART SENSE (Kmart) ASPIRIN 81 mg/1 49738-078_f040213c-135b-4bee-9e29-c79321fe0c2a 49738-078 HUMAN OTC DRUG LITTLE ONES ORIGINAL ETHYL ALCOHOL LIQUID TOPICAL 20130812 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION ALCOHOL 700 mg/mL 49738-079_03bb27e2-67c0-41ad-89a1-ea5eab4da5b8 49738-079 HUMAN OTC DRUG SMART SENSE ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131107 OTC MONOGRAPH NOT FINAL part333E KMARTK CORPORATION ALCOHOL 700 mg/mL 49738-079_70156c58-74a0-46d5-ba10-4ae9723285c8 49738-079 HUMAN OTC DRUG SMART SENSE ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131107 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION ALCOHOL 700 mg/mL 49738-080_23d9e230-e477-4348-baf4-eb89aa6a067c 49738-080 HUMAN OTC DRUG LITTLE ONES LAVENDER ETHYL ALCOHOL LIQUID TOPICAL 20130812 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION ALCOHOL 700 mg/mL 49738-081_1cdfb143-cdcf-4f49-8d41-7e28ceaec829 49738-081 HUMAN OTC DRUG smart sense 3 day treatment Miconazole nitrate KIT 20110525 ANDA ANDA075329 Kmart Corporation 49738-094_4fbafdb0-762e-431f-91a1-3791ecfec4b8 49738-094 HUMAN OTC DRUG Smart Sense nasal decongestant pe maximum strength Phenylephrine Hydrochloride TABLET ORAL 20101229 OTC MONOGRAPH FINAL part341 Kmart Corporation PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 49738-096_ebe1d422-2c31-4ce4-897e-e75e146f79f8 49738-096 HUMAN OTC DRUG smart sense flu and severe cold and cough daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20120117 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 49738-100_5c313084-fd5d-48f1-a223-3313b093a527 49738-100 HUMAN OTC DRUG IMAGE ESSENTIALS SPRING FRESH TRICLOSAN LIQUID TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN 4.6 mg/mL 49738-100_fccef42e-a9ea-4e52-b0dd-99ff75d586c7 49738-100 HUMAN OTC DRUG IMAGE ESSENTIALS SPRING FRESH TRICLOSAN LIQUID TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN 4.6 mg/mL 49738-101_ac089b6c-873b-4c01-9b17-b5804fa64e5a 49738-101 HUMAN OTC DRUG IMAGE ESSENTIALS SPRING FRESH TRICLOSAN LIQUID TOPICAL 20131120 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN 4.6 mg/mL 49738-105_504772ca-5876-4a3b-9044-d4b1be079784 49738-105 HUMAN OTC DRUG Smart Sense Pain Relief childrens Acetaminophen SUSPENSION ORAL 20100701 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 160 mg/5mL 49738-109_c4922e5c-99dd-4dc5-b76c-7327da4d6a75 49738-109 HUMAN OTC DRUG Mucus DM Dextromethorphan Hydrobromide and Guaifenesin TABLET ORAL 20140131 OTC MONOGRAPH FINAL part341 SMART SENSE (Kmart) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 49738-110_ebd9aa34-6b66-4645-bbaa-51e087b54bbd 49738-110 HUMAN OTC DRUG smart sense feminine Povidone-iodine KIT 20091214 OTC MONOGRAPH NOT FINAL part333A Kmart Corporation 49738-111_bd389554-c994-4c05-89a0-b0a6845a1324 49738-111 HUMAN OTC DRUG Oral Saline Laxative Ginger Lemon dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20120831 OTC MONOGRAPH NOT FINAL part334 Kmart Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 2.7; 7.2 g/15mL; g/15mL 49738-116_96dcf5f0-c763-4d7d-8520-d736ea25dd3b 49738-116 HUMAN OTC DRUG Smart Sense Ranitidine Ranitidine TABLET ORAL 20101124 ANDA ANDA078653 Kmart Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 49738-117_24e0136c-831b-4932-a649-bb5c05040367 49738-117 HUMAN OTC DRUG Smart Sense Acid Reducer Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120522 ANDA ANDA202319 Kmart Corporation LANSOPRAZOLE 15 mg/1 49738-124_ed79daf9-b750-4733-840d-0c375024c8b4 49738-124 HUMAN OTC DRUG smart sense nicotine polacrilex Nicotine Polacrilex LOZENGE ORAL 20110608 ANDA ANDA090711 Kmart Corporation NICOTINE 2 mg/1 49738-130_a0436dd9-3ad5-43d9-913a-cce5f4238dc9 49738-130 HUMAN OTC DRUG smart sense pain relief Acetaminophen SUSPENSION ORAL 19951117 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 160 mg/5mL 49738-140_fea17ba6-49fe-402c-b958-ac08c7c1bf77 49738-140 HUMAN OTC DRUG smart sense naproxen sodium Naproxen sodium TABLET, FILM COATED ORAL 20101001 ANDA ANDA074661 Kmart Corporation NAPROXEN SODIUM 220 mg/1 49738-141_6094effc-670c-4d77-b7f9-d963fcd4b577 49738-141 HUMAN OTC DRUG Smart Sense Acid Reducer Famotidine TABLET ORAL 20101214 ANDA ANDA075400 Kmart Corporation FAMOTIDINE 10 mg/1 49738-142_e1d92555-73c2-4b4b-8929-87cd5471f4f4 49738-142 HUMAN OTC DRUG smart sense vagicaine maximum strength Benzocaine, Resorcinol CREAM TOPICAL 20110223 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation BENZOCAINE; RESORCINOL 20; 3 g/100g; g/100g 49738-150_e260a19e-cbd4-4350-b01c-58cadbf62870 49738-150 HUMAN OTC DRUG Stool Softener Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131230 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) DOCUSATE SODIUM 250 mg/1 49738-154_07af2413-edd0-4611-bff5-7d01b6a8691d 49738-154 HUMAN OTC DRUG Smart Sense Athletes Foot tolnaftate SPRAY TOPICAL 20110421 OTC MONOGRAPH FINAL part333C Kmart Corporation TOLNAFTATE 1 g/100g 49738-160_dd1e5abc-8d09-4832-8521-fb7627323f0b 49738-160 HUMAN OTC DRUG Senna S docusate sodium and sennosides TABLET ORAL 20121231 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 49738-165_69152eff-fae0-4b01-b6fd-0eea83c4ae3e 49738-165 HUMAN OTC DRUG smart sense allergy and congestion relief Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20110721 ANDA ANDA075706 Kmart Corporation LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 49738-166_63c79a57-6528-4c79-b594-a41e813ab59d 49738-166 HUMAN OTC DRUG Smart Sense ibuprofen Ibuprofen SUSPENSION ORAL 20100520 ANDA ANDA074937 Kmart Corporation IBUPROFEN 100 mg/5mL 49738-168_b1a6a2d7-3244-4df1-b873-62a945159742 49738-168 HUMAN OTC DRUG ANTIBACTERIAL FOAMING REFILL TRICLOSAN LIQUID TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .46 mL/100mL 49738-170_b8ee659b-3e05-47a8-a50e-d6f2455914d0 49738-170 HUMAN OTC DRUG smart sense nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20110726 ANDA ANDA076789 Kmart Corporation NICOTINE 4 mg/1 49738-171_8b85dbef-0d38-4703-9ccf-9f226d355c63 49738-171 HUMAN OTC DRUG Image Essentials Miconazole Treatment Miconazole nitrate KIT 20141203 ANDA ANDA075329 Kmart Corporation 49738-175_853da525-93f1-419c-b155-9309e2247d69 49738-175 HUMAN OTC DRUG smart sense pain relief childrens Acetaminophen SUSPENSION ORAL 20100715 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 160 mg/5mL 49738-176_d5b9925d-96c4-488e-8e2e-22a14d0e3d76 49738-176 HUMAN OTC DRUG Smart Sense All Day Allergy D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20110314 ANDA ANDA077170 Kmart Corporation CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 49738-177_55f977de-3fcd-4da9-a0c4-21ee0df9d919 49738-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110516 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .46 mL/100mL 49738-178_b030f080-38bf-437c-9b41-0a11ba59854f 49738-178 HUMAN OTC DRUG Kmart Corporation Healthy Protection Fluoride PASTE, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 Kmart Corporation STANNOUS FLUORIDE .454 g/100g 49738-182_dd3992c9-e060-4f2b-97dc-71f11574a7a7 49738-182 HUMAN OTC DRUG Smart Sense Hydrocortisone Hydrocortisone CREAM TOPICAL 20131217 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE 1 g/100g 49738-184_0fc266ea-375f-43e5-b82f-b3fb6d0a2cf3 49738-184 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20120619 OTC MONOGRAPH NOT FINAL part343 SMART SENSE (Kmart) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 49738-188_8fd4082a-9cf3-44aa-9b26-32726e7c4629 49738-188 HUMAN OTC DRUG smart sense hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140324 OTC MONOGRAPH FINAL part346 Kmart Corporation MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 49738-189_befba295-f3e5-4ff7-a337-315fb54966cc 49738-189 HUMAN OTC DRUG Smart Sense Childrens Allergy Cetirizine HCl SOLUTION ORAL 20140102 ANDA ANDA204226 Kmart Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL 49738-190_d073897b-d296-4a4c-bd80-e9c757b37f5e 49738-190 HUMAN OTC DRUG Smart Sense Nicotine Nicotine Polacrilex LOZENGE ORAL 20110510 ANDA ANDA090711 Kmart Corporation NICOTINE 4 mg/1 49738-191_ff60e3ed-47ca-4488-ba5c-d6a71b4e4f82 49738-191 HUMAN OTC DRUG smart sense ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20100527 ANDA ANDA079113 Kmart Corporation DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 49738-194_413c7671-f223-4ab7-88da-59225771d954 49738-194 HUMAN OTC DRUG Smart Sense Acid Reducer Maximum Strength Famotidine TABLET ORAL 20101221 ANDA ANDA077351 Kmart Corporation FAMOTIDINE 20 mg/1 49738-198_a0589d71-d193-4da7-850c-d9c5d002cefb 49738-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120930 ANDA ANDA078682 SMART SENSE (Kmart) IBUPROFEN 200 mg/1 49738-199_5037cb1b-ad8e-4b6d-a087-2098e06612e8 49738-199 HUMAN OTC DRUG Smart Sense miconazole 1 Miconazole nitrate KIT 20100616 ANDA ANDA079114 Kmart Corporation 49738-200_fe437e83-2817-465f-b3cb-b2dd5fd16ec1 49738-200 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333A Kmart Corporation BENZALKONIUM CHLORIDE .13 mL/mL 49738-201_c60681ee-e262-4340-b516-031f8317561b 49738-201 HUMAN OTC DRUG smart sense famotidine Famotidine TABLET ORAL 20140218 ANDA ANDA075400 Kmart Corporation FAMOTIDINE 10 mg/1 49738-202_8c2c3744-32dd-4648-9517-cfcdcd3ceae4 49738-202 HUMAN OTC DRUG image essentials hair regrowth treatment minoxidil SOLUTION TOPICAL 20110620 ANDA ANDA075357 Kmart Corporation MINOXIDIL 2 g/100mL 49738-203_5433ceb5-c530-4d28-9c5d-c27e9b40d66d 49738-203 HUMAN OTC DRUG Smart Sense Triple Antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20140519 OTC MONOGRAPH FINAL part333B Kmart Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 49738-205_b8279932-e006-4b8b-a60e-1f5ee7edc63c 49738-205 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20020426 OTC MONOGRAPH FINAL part358H Kmart Corporation COAL TAR 2.5 mL/100L 49738-206_4a58ef88-dce6-49fe-b02e-0bbd64a3acce 49738-206 HUMAN OTC DRUG smart sense nicotine mint Nicotine Polacrilex GUM, CHEWING ORAL 20110629 ANDA ANDA078325 Kmart Corporation NICOTINE 2 mg/1 49738-210_4965491c-e3e4-4004-a9dc-bed12003d2f4 49738-210 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL, MENTHOL, METYL SALICYLATE, THYMOL MOUTHWASH ORAL 19960821 OTC MONOGRAPH NOT FINAL part348 KMart Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 49738-211_89a624a2-6f6d-4d2f-9353-9183025f5170 49738-211 HUMAN OTC DRUG Cetirizine HCl Cetirizine Hydrochloride CAPSULE ORAL 20130501 NDA NDA022429 SMART SENSE (Kmart) CETIRIZINE HYDROCHLORIDE 10 mg/1 49738-213_a4604171-d0a0-4365-993f-ddc6a9ff3496 49738-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20100928 OTC MONOGRAPH FINAL part355 Kmart Corporation SODIUM FLUORIDE .05 kg/100L 49738-215_365013d1-6f01-4d6b-aabb-80ae1e0c63d5 49738-215 HUMAN OTC DRUG ANTIBACTERIAL MANDARIN AND GRAPEFRUIT TRICLOSAN LIQUID TOPICAL 20110707 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .15 mL/100mL 49738-216_857d3687-f334-4d2c-a8a6-3ab8cf3cc9f2 49738-216 HUMAN OTC DRUG ANTIBACTERIAL REFILL TRICLOSAN LIQUID TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .15 L/100L 49738-216_daaf0bba-5114-4699-81a6-a56ff7910227 49738-216 HUMAN OTC DRUG ANTIBACTERIAL REFILL TRICLOSAN LIQUID TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .15 L/100L 49738-217_a7311f6f-5413-4897-8885-05b43cf5c860 49738-217 HUMAN OTC DRUG smart sense pain relief 8 hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101022 ANDA ANDA075077 Kmart Corporation ACETAMINOPHEN 650 mg/1 49738-220_bdcff56d-93b1-4048-b857-f192af4e0d89 49738-220 HUMAN OTC DRUG Image Essentials Antibacterial Gold TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Kmart Corporation TRICLOSAN .15 mL/100mL 49738-227_4eefa40f-472a-4d5f-adb2-4fae43be9d84 49738-227 HUMAN OTC DRUG Smart Sense pain relief extra strength Acetaminophen TABLET, COATED ORAL 20101215 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 500 mg/1 49738-230_12d50c85-548a-4158-ad8d-84e730d75f80 49738-230 HUMAN OTC DRUG Nighttime Sleep-Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20130331 OTC MONOGRAPH FINAL part341 SMART SENSE (Kmart) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 49738-236_f32f7637-8b12-4e5b-9f96-7e1dace8580f 49738-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 SMART SENSE (Kmart) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 49738-237_16e99d5f-30d2-4fb5-abc6-2b9e4e76bcd5 49738-237 HUMAN OTC DRUG smart sense childrens pain relief Acetaminophen SUSPENSION ORAL 20140312 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 160 mg/5mL 49738-238_2162b279-f1fe-44fd-bf30-5d0883a5e6dc 49738-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) DOCUSATE SODIUM 100 mg/1 49738-244_50da2237-afdf-4079-8df8-cf3ca0e83f5e 49738-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) DOCUSATE SODIUM 100 mg/1 49738-251_34bb2993-d0f9-4ce0-8637-aabcd0d64397 49738-251 HUMAN OTC DRUG smart sense analgesic Trolamine Salicylate CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation TROLAMINE SALICYLATE 10 g/100g 49738-252_26af7ff3-c8b9-469e-bff2-361aaea1dd25 49738-252 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl, TABLET ORAL 20140331 OTC MONOGRAPH FINAL part338 SMART SENSE (Kmart) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49738-255_130462e5-3712-4500-9290-a54d901a941d 49738-255 HUMAN OTC DRUG smart sense ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20100514 ANDA ANDA075217 Kmart Corporation IBUPROFEN 50 mg/1.25mL 49738-258_b80f3af5-44da-4eef-b79b-9c766f699aee 49738-258 HUMAN OTC DRUG STOOL SOFTENER Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) DOCUSATE SODIUM 250 mg/1 49738-269_bf2e978d-b7b2-4600-98c5-ffc38a8f83b0 49738-269 HUMAN OTC DRUG Image Essentials Vagicaine Benzocaine, Resorcinol CREAM TOPICAL 20140327 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation BENZOCAINE; RESORCINOL 20; 3 g/100g; g/100g 49738-271_6de9e6a4-bc1c-4796-a2dc-38271b63a3ca 49738-271 HUMAN OTC DRUG Smart Sense Acid Reducer Ranitidine TABLET ORAL 20101215 ANDA ANDA076760 Kmart Corporation RANITIDINE HYDROCHLORIDE 75 mg/1 49738-272_1f7d15e3-f0da-409c-a27d-77e9392b73bd 49738-272 HUMAN OTC DRUG smart sense sinus Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20101203 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 49738-274_6384f623-d152-401d-838d-84fd9caac7cd 49738-274 HUMAN OTC DRUG smart sense aspirin Aspirin TABLET, CHEWABLE ORAL 20100604 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ASPIRIN 81 mg/1 49738-277_e4c74528-9911-4490-a3a4-0432fb58081d 49738-277 HUMAN OTC DRUG Smart Sense Aspirin Aspirin TABLET, FILM COATED ORAL 20101017 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ASPIRIN 81 mg/1 49738-279_3eb7905a-f6a0-47e7-b233-2f2a193c7706 49738-279 HUMAN OTC DRUG smart sense hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141002 OTC MONOGRAPH FINAL part346 Kmart Corporation COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 49738-288_2c44684b-22cf-4442-849f-871929b4c978 49738-288 HUMAN OTC DRUG Smart Sense Childrens Mucus Relief Guaifenesin LIQUID ORAL 20101203 OTC MONOGRAPH FINAL part341 Kmart Corporation GUAIFENESIN 100 mg/5mL 49738-289_83fba880-18a5-46e6-8ea4-5b98a94d3d73 49738-289 HUMAN OTC DRUG Smart Sense pain relief infants Acetaminophen SUSPENSION/ DROPS ORAL 20100813 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 80 mg/.8mL 49738-294_08b887f5-8bff-4723-a88f-3adfb6cf2c24 49738-294 HUMAN OTC DRUG ANTIBACTERIAL REFILL TRICLOSAN LIQUID TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .15 L/100L 49738-294_55460a49-667c-4346-b003-dd583911d096 49738-294 HUMAN OTC DRUG ANTIBACTERIAL REFILL TRICLOSAN LIQUID TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .15 L/100L 49738-294_fb8d3933-9aa6-4054-b420-562be1e48834 49738-294 HUMAN OTC DRUG ANTIBACTERIAL REFILL TRICLOSAN LIQUID TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .15 L/100L 49738-295_7467d8eb-69a1-49fb-b6ba-e47eab3b4ae4 49738-295 HUMAN OTC DRUG SMART SENSE TOLNFTATE ANTIFUNGAL TOLNAFTATE CREAM TOPICAL 20111114 OTC MONOGRAPH FINAL part333C KMART CORPORATION TOLNAFTATE 10 mg/g 49738-296_b998fd1f-8c57-485f-813b-f1ed1fddd824 49738-296 HUMAN OTC DRUG Smart Sense Cold and Hot Extra Strength Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation MENTHOL 750 mg/1 49738-298_af432e3f-e862-4373-98e4-c2c83deb6e93 49738-298 HUMAN OTC DRUG IMAGE ESSENTIALS SPRING FRESH TRICLOSAN LIQUID TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN 1.5 mg/mL 49738-299_dd7e426a-b276-4a72-af57-83f052829934 49738-299 HUMAN OTC DRUG Smart Sense Famotidine Famotidine TABLET ORAL 20140207 ANDA ANDA077351 Kmart Corporation FAMOTIDINE 20 mg/1 49738-300_51bca0e5-0bdf-46df-bec6-870a72a2861a 49738-300 HUMAN OTC DRUG Image Essentials Hair Regrowth Treatment For Men Minoxidil AEROSOL, FOAM TOPICAL 20120716 ANDA ANDA091344 Kmart Corporation MINOXIDIL 5 g/100g 49738-304_b4f6b256-1092-4db7-b28f-e4293c870a8c 49738-304 HUMAN OTC DRUG smart sense nasal original oxymetazoline hydrochloride SPRAY NASAL 20100903 OTC MONOGRAPH FINAL part341 Kmart Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 49738-306_74fe9181-354b-4316-a76f-568f07fd7ec6 49738-306 HUMAN OTC DRUG Smart Sense Clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20110407 ANDA ANDA090685 Kmart Corporation POLYETHYLENE GLYCOL 3350 17 g/17g 49738-310_614e6fcf-6f12-4225-b125-3ea7f9ea09bf 49738-310 HUMAN OTC DRUG Smart Sense tussin adult Guaifenesin SYRUP ORAL 20110117 OTC MONOGRAPH FINAL part341 Kmart Corporation GUAIFENESIN 200 mg/10mL 49738-313_96df6b3d-9a71-42ee-b205-c70df5828cbc 49738-313 HUMAN OTC DRUG Smart Sense Hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20130406 OTC MONOGRAPH FINAL part346 Kmart Corporation COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g 49738-318_d3a3309a-8c08-4b10-9d93-f4a50316458d 49738-318 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 19890715 OTC MONOGRAPH NOT FINAL part356 Kmart Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 49738-320_ecc34f8e-3746-49fa-a086-e7c8f6eaec1f 49738-320 HUMAN OTC DRUG IMAGE ESSENTIALS OATMEAL MOISTURIZING DIMETHICONE LOTION TOPICAL 20140225 OTC MONOGRAPH FINAL part347 KMART CORPORATION DIMETHICONE 12.5 mg/mL 49738-321_15817be7-df99-4130-ba1f-75792a146fbf 49738-321 HUMAN OTC DRUG Smart Sense Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20110621 ANDA ANDA077355 Kmart Corporation CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 49738-328_10a71d58-6546-4263-ade5-9e9c41bb5b65 49738-328 HUMAN OTC DRUG smart sense sore throat Phenol SPRAY ORAL 20101216 OTC MONOGRAPH NOT FINAL part356 Kmart Corporation PHENOL 1.4 g/100mL 49738-335_d6ff14e5-5b2d-4ecc-b31f-9b44c4b32b4b 49738-335 HUMAN OTC DRUG smart sense nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120508 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 49738-339_bc7a4cae-985d-420b-aff1-78d1c69f693c 49738-339 HUMAN OTC DRUG KMart Smart Sense Benzocaine PASTE, DENTIFRICE TOPICAL 20131201 OTC MONOGRAPH FINAL part333B KMart BENZOCAINE 20 g/100g 49738-340_b53ea917-dbb1-4bcb-a685-0c87143fee5b 49738-340 HUMAN OTC DRUG Hygienic Cleansing Pads witch hazel SOLUTION TOPICAL 20060822 OTC MONOGRAPH FINAL part346 Kmart Corporation WITCH HAZEL .5 mL/mL 49738-344_e9071ae2-d4ee-4211-9b23-5abeeeef5bba 49738-344 HUMAN OTC DRUG smart sense nicotine Nicotine LOZENGE ORAL 20110613 ANDA ANDA077007 Kmart Corporation NICOTINE 2 mg/1 49738-350_7eac48fb-b063-4145-9595-d4867df6bb59 49738-350 HUMAN OTC DRUG IMAGE ESSENTIALS WHITE PETROLATUM JELLY TOPICAL 20130610 OTC MONOGRAPH FINAL part346 KMART CORPORATION PETROLATUM 1000 mg/g 49738-359_ab341bdb-cb52-4009-ade4-a8f097260e2e 49738-359 HUMAN OTC DRUG smart sense tussin dm Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20101017 OTC MONOGRAPH FINAL part341 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 49738-361_b2aee5c7-7e02-496c-bc3d-b60e90d240f0 49738-361 HUMAN OTC DRUG smart sense ranitidine Ranitidine TABLET, FILM COATED ORAL 20140321 ANDA ANDA091429 Kmart Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 49738-368_e0a3f670-e44b-4ecd-8351-6592d7623cce 49738-368 HUMAN OTC DRUG Smart Sense Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20101008 ANDA ANDA074661 Kmart Corporation NAPROXEN SODIUM 220 mg/1 49738-369_132c438d-2da0-4f5d-bc83-1dfd990916dc 49738-369 HUMAN OTC DRUG smart sense anti itch maximum strength Hydrocortisone CREAM TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE 1 g/100g 49738-372_7af99a83-74d1-44c2-a6cf-78244b1e529c 49738-372 HUMAN OTC DRUG Smart Sense Pain Relief Acetaminophen CAPSULE, COATED ORAL 20130807 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 500 mg/1 49738-374_48f958d4-72c9-460e-88a9-8b611d16ef83 49738-374 HUMAN OTC DRUG Smart Sense migraine relief Acetaminophen, Aspirin, Caffeine TABLET ORAL 20100527 ANDA ANDA075794 Kmart Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 49738-375_d92bac10-7b62-4ea5-867b-73d180a30462 49738-375 HUMAN OTC DRUG Smart Sense Allergy and Congestion Relief-D Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20140218 ANDA ANDA075706 Kmart Corporation LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 49738-376_2c2e98a7-5cff-454b-a5ee-377153bc6dd3 49738-376 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20141130 OTC MONOGRAPH NOT FINAL part356 SMART SENSE (Kmart) PHENOL 1.4 g/100mL 49738-377_46303345-ce31-4d6c-9363-e611fa81ec19 49738-377 HUMAN OTC DRUG Smart Sense Anti Diarrheal Loperamide Hydrochloride SOLUTION ORAL 20110203 ANDA ANDA073243 Kmart Corporation LOPERAMIDE HYDROCHLORIDE 1 mg/5mL 49738-379_873e88e5-b985-42ad-a463-9255b5086e83 49738-379 HUMAN OTC DRUG smart sense allergy Diphenhydramine Hydrochloride LIQUID ORAL 20110113 OTC MONOGRAPH FINAL part341 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 49738-384_7121a8ff-f07e-4c75-a929-3e3e9ea470ba 49738-384 HUMAN OTC DRUG Smart Sense Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130805 ANDA ANDA091135 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 49738-388_490cf8de-5ac3-4f36-89aa-fcbee3411a9a 49738-388 HUMAN OTC DRUG smart sense nasal Oxymetazoline HCl SPRAY NASAL 20110126 OTC MONOGRAPH FINAL part341 Kmart Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 49738-394_109640e2-e9f0-45ae-b639-eb682442b63a 49738-394 HUMAN OTC DRUG smart sense hemorrhoidal Cocoa butter, Phenylephrine HCl, Shark liver oil SUPPOSITORY RECTAL 20110126 OTC MONOGRAPH FINAL part346 Kmart Corporation COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2137.5; 75; 6.375 mg/1; mg/1; mg/1 49738-397_c3672cb5-c02d-4306-aebe-2324584994e9 49738-397 HUMAN OTC DRUG Smart Sense Childrens Pain Relief Acetaminophen LIQUID ORAL 20130805 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 160 mg/5mL 49738-399_a3d337cc-9b02-46c4-b18d-9eb23f5718c1 49738-399 HUMAN OTC DRUG Smart Sense Arthritis Trolamine Salicylate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation TROLAMINE SALICYLATE 10 g/100g 49738-400_4ab0acc7-5451-48f3-acd4-9cdf09cb396a 49738-400 HUMAN OTC DRUG Smart Sense Hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 20110421 OTC MONOGRAPH FINAL part346 Kmart Corporation MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 49738-407_fc6275e2-7e0d-4e22-b30b-adefd6436042 49738-407 HUMAN OTC DRUG Smart Sense Cold Sore Treatment Benzalkonium chloride CREAM TOPICAL 20130408 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; ug/g 49738-409_5a86338c-04ed-4c09-9df1-55b8159caa11 49738-409 HUMAN OTC DRUG Smart Sense Stay Awake Caffeine TABLET ORAL 20101216 OTC MONOGRAPH FINAL part340 Kmart Corporation CAFFEINE 200 mg/1 49738-416_5b6ea13b-12f8-4e4d-974a-e44b2e044200 49738-416 HUMAN OTC DRUG Smart Sense Aspirin Aspirin TABLET ORAL 20100604 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ASPIRIN 325 mg/1 49738-419_642a2049-57bb-4011-b70a-bc153910a881 49738-419 HUMAN OTC DRUG Smart Sense Mucus Relief Cough Childrens Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20101209 OTC MONOGRAPH FINAL part341 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 49738-422_cbd22968-4aca-4c41-a3c6-5a93d9a46b05 49738-422 HUMAN OTC DRUG Smart Sense Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20110309 ANDA ANDA078326 Kmart Corporation NICOTINE 4 mg/1 49738-424_64cc0999-faca-459d-8076-0468458599bb 49738-424 HUMAN OTC DRUG Smart Sense Tolnaftate Antifungal Tolnaftate CREAM TOPICAL 20140923 OTC MONOGRAPH FINAL part333C Kmart Corporation TOLNAFTATE 10 mg/g 49738-425_97fffd8a-b133-4580-99f2-09e657dc2230 49738-425 HUMAN OTC DRUG smart sense allergy relief Fexofenadine HCl TABLET, FILM COATED ORAL 20110901 ANDA ANDA076447 Kmart Corporation FEXOFENADINE HYDROCHLORIDE 60 mg/1 49738-426_54b2355b-84c4-45a6-854e-f2c2501725e8 49738-426 HUMAN OTC DRUG Smart Sense Tioconazole 1 Tioconazole OINTMENT VAGINAL 20110711 ANDA ANDA075915 Kmart Corporation TIOCONAZOLE 6.5 g/100g 49738-429_0197aa2c-2e41-4fce-bdb4-bcbeb7bfaf46 49738-429 HUMAN OTC DRUG Smart Sense Anti Gas Simethicone CAPSULE, LIQUID FILLED ORAL 20140318 OTC MONOGRAPH FINAL part332 Kmart Corporation DIMETHICONE 180 mg/1 49738-430_0fce86a0-e21b-4644-985d-e9be42a42d18 49738-430 HUMAN OTC DRUG Eye Allergy Relief Pheniramine Maleate and Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20100831 NDA NDA020065 Kmart Corporation NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL 49738-431_85687f5b-4309-4d7a-9c7f-90811cacc4d4 49738-431 HUMAN OTC DRUG smart sense nightime sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20070629 OTC MONOGRAPH FINAL part338 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49738-432_4b9a6527-22fd-47ca-af9c-f61bc2948ee8 49738-432 HUMAN OTC DRUG Smart Sense Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 20110314 OTC MONOGRAPH FINAL part341 Kmart Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 49738-441_1ef6a6c0-74e1-41b0-9d0c-0af64d1c8a32 49738-441 HUMAN OTC DRUG smart sense sleep aid Doxylamine succinate TABLET ORAL 20101229 ANDA ANDA040167 Kmart Corporation DOXYLAMINE SUCCINATE 25 mg/1 49738-444_1ac78d45-7499-4ffb-8217-c6be7908e568 49738-444 HUMAN OTC DRUG Smart Sense Migraine Formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20140417 ANDA ANDA075794 Kmart Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 49738-453_fa196684-98da-47af-bd78-99d1fef06960 49738-453 HUMAN OTC DRUG Smart Sense Childrens Nighttime Cold and Cough Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20140418 OTC MONOGRAPH FINAL part341 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 49738-454_f5119d9f-5a8c-44f9-89c7-5602628ca009 49738-454 HUMAN OTC DRUG Artifical Tears Glycerin and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20100901 OTC MONOGRAPH FINAL part349 Kmart Corporation GLYCERIN; PROPYLENE GLYCOL .3; 1 mg/100mL; mL/100mL 49738-456_54f32e92-c98f-4868-83e7-63cf075a2de7 49738-456 HUMAN OTC DRUG Smart Sense Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20110907 ANDA ANDA076777 Kmart Corporation NICOTINE 2 mg/1 49738-458_76dc9367-a74d-4223-8c9a-0f6371cd6351 49738-458 HUMAN OTC DRUG Smart Sense all day allergy Cetirizine Hydrochloride TABLET ORAL 20110118 ANDA ANDA078336 Kmart Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 49738-459_4e236dca-c3d3-449c-a90c-d81f652a4c1d 49738-459 HUMAN OTC DRUG smart sense nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110913 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 49738-461_8df4cdb7-5eb3-4fff-9eda-98ff24197af6 49738-461 HUMAN OTC DRUG smart sense ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20100624 ANDA ANDA076359 Kmart Corporation IBUPROFEN 100 mg/1 49738-462_da6c5fdb-70e3-4128-86ee-9aa5d4c7cdad 49738-462 HUMAN OTC DRUG smart sense allergy diphenhydramine hydrochloride CAPSULE ORAL 19960123 OTC MONOGRAPH FINAL part341 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49738-466_2d9c3d5a-86f3-4bb5-9309-04edfbc72688 49738-466 HUMAN OTC DRUG Smart Sense Childrens allergy relief Diphenhydramine HCl SOLUTION ORAL 20140221 OTC MONOGRAPH FINAL part341 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 49738-467_8f9a11a9-070a-4db2-ae1e-863da0ba66e8 49738-467 HUMAN OTC DRUG Smart Sense Aspirin Aspirin TABLET, CHEWABLE ORAL 20100604 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ASPIRIN 81 mg/1 49738-470_802346bf-5546-41a8-ad3a-68b884dcb946 49738-470 HUMAN OTC DRUG DayTime Cold Flu Non-Drowsy ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED ORAL 20121231 OTC MONOGRAPH FINAL part341 SMART SENSE (Kmart) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 49738-471_db0500b6-96e8-4590-8198-c6e9690e87a9 49738-471 HUMAN OTC DRUG Smart Sense Ranitidine Ranitidine TABLET, FILM COATED ORAL 20101124 ANDA ANDA091429 Kmart Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 49738-476_c3374bc6-d388-4e78-982d-6d0ab57279e3 49738-476 HUMAN OTC DRUG Smart Sense Sleep Aid Diphenhydramine Hydrochloride TABLET ORAL 20140418 OTC MONOGRAPH FINAL part338 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49738-478_5ad647b7-4404-4b02-84aa-b11b1516ad67 49738-478 HUMAN OTC DRUG SMART SENSE ORIGINAL ETHYL ALCOHOL LIQUID TOPICAL 20131107 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION ALCOHOL 700 mg/mL 49738-478_6d5ee917-688c-434b-b3a4-1048faee9531 49738-478 HUMAN OTC DRUG SMART SENSE ORIGINAL ETHYL ALCOHOL LIQUID TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION ALCOHOL 700 mg/mL 49738-479_c2c6f4cc-c190-4cda-8b67-2951e07e75d5 49738-479 HUMAN OTC DRUG smart sense allergy Diphenhydramine Hydrochloride TABLET ORAL 20110106 OTC MONOGRAPH FINAL part341 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49738-480_987551e2-ccc3-4c98-b2a7-4ab382be559c 49738-480 HUMAN OTC DRUG Nighttime cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20121231 OTC MONOGRAPH FINAL part341 SMART SENSE (Kmart) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 49738-484_cfb601aa-248f-4127-8c82-4cc88a93bb6c 49738-484 HUMAN OTC DRUG Smart Sense pain relief extra strength Acetaminophen TABLET ORAL 20100520 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 500 mg/1 49738-490_ebf6e56d-31ff-4a4a-b03f-3585fee6031a 49738-490 HUMAN OTC DRUG Smart Sense naproxen sodium Naproxen Sodium TABLET ORAL 20100715 ANDA ANDA074661 Kmart Corporation NAPROXEN SODIUM 220 mg/1 49738-497_56f06298-7e03-42b0-b76d-a7fbc2c6af6b 49738-497 HUMAN OTC DRUG Therapeutic Coal tar SHAMPOO TOPICAL 20110509 OTC MONOGRAPH FINAL part358H KMart Corporation COAL TAR 10.2 mg/mL 49738-498_2d266e17-474c-42b0-9d07-073e5f938c34 49738-498 HUMAN OTC DRUG smart sense mucus er Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130805 ANDA ANDA078912 Kmart Corporation GUAIFENESIN 600 mg/1 49738-499_6f42ae25-ff46-4810-b425-15e1fb9e448b 49738-499 HUMAN OTC DRUG Smart Sense Pump Mist Oxymetazoline HCl SPRAY NASAL 20140128 OTC MONOGRAPH FINAL part341 Kmart Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 49738-500_d30d9563-e610-4900-a936-2ddb46e86725 49738-500 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130430 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) DOCUSATE SODIUM 100 mg/1 49738-504_5609e605-cfe3-4209-9d92-385aafef4acf 49738-504 HUMAN OTC DRUG Smart Sense Allergy Relief diphenhydramine HCl CAPSULE ORAL 20140210 OTC MONOGRAPH FINAL part341 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49738-516_988c2959-464c-45ea-b301-ff02879c0f3d 49738-516 HUMAN OTC DRUG smart sense tussin cf adult Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20110112 OTC MONOGRAPH FINAL part341 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 49738-517_9fdecc86-5d5d-4292-8620-2711481586a5 49738-517 HUMAN OTC DRUG smart sense ibuprofen gluten free Ibuprofen TABLET, FILM COATED ORAL 20100618 ANDA ANDA077349 Kmart Corporation IBUPROFEN 200 mg/1 49738-519_60c1f39f-e86f-4618-8abe-84fcb6e4ac7c 49738-519 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 500 mg/1 49738-530_b2bed99f-5316-4f27-b76e-bbdc4a4608fd 49738-530 HUMAN OTC DRUG Oil-Free Acne Wash Salicylic Acid LOTION TOPICAL 20130801 OTC MONOGRAPH FINAL part333D Kmart Corporation SALICYLIC ACID 2 g/100mL 49738-532_e8092696-8613-467f-9f00-6f5a5658ac07 49738-532 HUMAN OTC DRUG Smart Sense Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20110606 ANDA ANDA076779 Kmart Corporation NICOTINE 4 mg/1 49738-536_58b35fa4-2bfa-4881-9fb6-da80ba672b2f 49738-536 HUMAN OTC DRUG Smart Sense Antibiotic Bacitracin OINTMENT TOPICAL 20101214 OTC MONOGRAPH FINAL part333B Kmart Corporation BACITRACIN 500 [USP'U]/g 49738-541_5c6bfbdb-4f8b-4ebd-9dce-471ca9b94024 49738-541 HUMAN OTC DRUG anti itch maximum strength Hydrocortisone CREAM TOPICAL 20101223 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE 1 g/100g 49738-544_af2e2f24-c3e3-40f8-adfe-56fd7d920fbf 49738-544 HUMAN OTC DRUG Smart Sense arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100909 ANDA ANDA075077 Kmart Corporation ACETAMINOPHEN 650 mg/1 49738-546_9249e3ab-3617-4773-aa9a-ff499d6ee6c5 49738-546 HUMAN OTC DRUG smart sense Complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20110506 ANDA ANDA077355 Kmart Corporation CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 49738-551_7a1fcc3f-44e8-4901-8cbe-0c512fcde547 49738-551 HUMAN OTC DRUG Smart sense Iceberg Blue Eucalyptol, Menthol, Methyl Salicylate, Thymol LIQUID ORAL 20130422 OTC MONOGRAPH NOT FINAL part356 Kmart Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 49738-552_1c7cb46c-2865-4290-adc4-5a5df3f104c1 49738-552 HUMAN OTC DRUG SMART SENSE ANTICAVITY SODIUM FLUORIDE LIQUID ORAL 20130509 OTC MONOGRAPH FINAL part355 KMART CORPORATION SODIUM FLUORIDE .2 mg/mL 49738-553_cc7d57bf-7b5e-4ad3-8481-40be811f0935 49738-553 HUMAN OTC DRUG SMART SENSE ALCOHOL FREE CETYLPYRIDINIUM CHLORIDE LIQUID ORAL 20130509 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION CETYLPYRIDINIUM CHLORIDE .7 mg/mL 49738-554_e99e0f9f-b4b8-478f-a21c-79cd724c02af 49738-554 HUMAN OTC DRUG SMART SENSE ALCOHOL FREE SODIUM FLUORIDE LIQUID ORAL 20130509 OTC MONOGRAPH FINAL part355 KMART CORPORATION SODIUM FLUORIDE .5 mg/mL 49738-555_72219800-a4dd-4dc7-a0ad-9ce266237e39 49738-555 HUMAN OTC DRUG SMART SENSE CITRUS EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL LIQUID ORAL 20130509 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .06; .064 mg/mL; mg/mL; mg/mL; mg/mL 49738-555_84916c58-5f36-466f-ba09-08ae808c8258 49738-555 HUMAN OTC DRUG SMART SENSE CITRUS EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .06; .064 mg/mL; mg/mL; mg/mL; mg/mL 49738-556_7ccbff24-3c70-4df1-89fd-1a66895f36af 49738-556 HUMAN OTC DRUG SMART SENSE ORIGINAL FLAVOR EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 49738-556_d82e7e36-82f7-4ccb-ad87-a887474c473b 49738-556 HUMAN OTC DRUG SMART SENSE ORIGINAL FLAVOR EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 49738-557_79bc9379-7814-481c-940a-598d1eec2cab 49738-557 HUMAN OTC DRUG SMART SENSE BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 49738-557_c10cb010-2ccf-4d81-a5cc-814fcb590447 49738-557 HUMAN OTC DRUG SMART SENSE BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 49738-557_c7eb62aa-b110-4129-8e68-59b8a0f3b7c4 49738-557 HUMAN OTC DRUG SMART SENSE BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140319 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 49738-557_da935006-0cfb-40a0-9e6b-f75683b9c34e 49738-557 HUMAN OTC DRUG SMART SENSE BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 49738-558_0e11677f-c35b-4bf9-9cb4-e063fb469d47 49738-558 HUMAN OTC DRUG SMART SENSE SPRING MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 49738-558_34fdf76b-ff8f-40e5-b373-969015022e90 49738-558 HUMAN OTC DRUG SMART SENSE SPRING MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140319 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 49738-558_949dd636-d8ba-4a5b-ae1e-3ccec300cd7b 49738-558 HUMAN OTC DRUG SMART SENSE SPRING MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 49738-558_9ad5b523-deb6-479e-a0d4-404949d3e56b 49738-558 HUMAN OTC DRUG SMART SENSE SPRING MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 49738-567_303164b1-0742-49ea-8d62-f7c27ea524b1 49738-567 HUMAN OTC DRUG smart sense daytime nighttime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130415 OTC MONOGRAPH FINAL part341 Kmart Corporation 49738-571_e5e54481-2bf9-44bc-bedb-732097513eba 49738-571 HUMAN OTC DRUG smart sense allergy relief fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110623 ANDA ANDA076447 Kmart Corporation FEXOFENADINE HYDROCHLORIDE 180 mg/1 49738-578_2e552d0d-b406-4f5f-afbf-3adce881875b 49738-578 HUMAN OTC DRUG Smart Sense Adult Tussin DM sugar free Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20130909 OTC MONOGRAPH FINAL part341 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 49738-582_c90b686b-c0ec-40a4-bbd3-9d7aec5a17d1 49738-582 HUMAN OTC DRUG little ones vitamin a and d Lanolin, Petrolatum OINTMENT TOPICAL 20110506 OTC MONOGRAPH FINAL part347 Kmart Corporation LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g 49738-588_d8063a7a-7ef7-4c27-aca2-87c66313333a 49738-588 HUMAN OTC DRUG Smart Sense Hydrocortisone Hydrocortisone CREAM TOPICAL 20140227 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE 1 g/100g 49738-594_65bdb4d9-b544-43a8-81f9-5654ea42c977 49738-594 HUMAN OTC DRUG smart sense nasal Oxymetazoline HCl SPRAY NASAL 20140401 OTC MONOGRAPH FINAL part341 Kmart Corporation OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL 49738-600_edc05451-822e-4c51-9d2e-55fae08ee657 49738-600 HUMAN OTC DRUG smart sense allergy relief Cetirizine Hydrochloride TABLET ORAL 20140418 ANDA ANDA078336 Kmart Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 49738-603_e8d713bf-b07f-4bc9-bcd1-6cc80d2fffc7 49738-603 HUMAN OTC DRUG Smart Sense DayTime acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20131206 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 49738-604_1389a795-2237-4c9a-b3c0-51994f623cc9 49738-604 HUMAN OTC DRUG smart sense ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20100604 ANDA ANDA072096 Kmart Corporation IBUPROFEN 200 mg/1 49738-612_b97a6df6-e979-4172-827b-37713cacd3ac 49738-612 HUMAN OTC DRUG Smart Sense Allergy Relief non drowsy Loratadine TABLET ORAL 20101124 ANDA ANDA076301 Kmart Corporation LORATADINE 10 mg/1 49738-617_90247c36-86bb-49c4-ac62-a63a62d01000 49738-617 HUMAN OTC DRUG Smart Sense Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Kmart Corporation POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 49738-619_446769a7-d050-49a2-9033-300065482702 49738-619 HUMAN OTC DRUG Acid Reducer Regular Strength Ranitidine TABLET ORAL 20130615 ANDA ANDA200536 Kmart Corporation RANITIDINE HYDROCHLORIDE 75 mg/1 49738-622_6e472e5e-f3dd-43c1-8086-d6d8a59d8345 49738-622 HUMAN OTC DRUG smart sense anti itch extra strength Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20110216 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 49738-626_08db02c3-c4af-40ff-8d39-1e8e943ce9e1 49738-626 HUMAN OTC DRUG Daily Moisturizing Broad Spectrum SPF15 Sunscreen Avobenzone, Homosalate, Octinoxate, Octocrylene LOTION TOPICAL 20131110 OTC MONOGRAPH NOT FINAL part352 Kmart Corporation AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3; 3; 5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL 49738-645_0746ceb4-3af0-4ac2-baa7-b5c7fa3840ac 49738-645 HUMAN OTC DRUG smart sense loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120514 ANDA ANDA091292 Kmart Corporation LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 49738-647_984f784e-2e5f-4e45-ac13-6cfa72f5fd3c 49738-647 HUMAN OTC DRUG smart sense ibuprofen Ibuprofen TABLET, COATED ORAL 20100617 ANDA ANDA072096 Kmart Corporation IBUPROFEN 200 mg/1 49738-655_291c8552-7c6f-40ae-a40d-46198ea8f8fe 49738-655 HUMAN OTC DRUG Extra Strength Pain Relief PM Acetaminophen and Diphenhydramine HCl CAPSULE ORAL 20071217 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 49738-656_dbe733d6-6f9e-4ea2-9cd4-dc87307544a2 49738-656 HUMAN OTC DRUG smart sense daytime acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20110201 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 49738-657_2966af65-3b88-4067-bdd4-76bc58bdbc40 49738-657 HUMAN OTC DRUG smart sense gas relief ultra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20110210 OTC MONOGRAPH FINAL part332 Kmart Corporation DIMETHICONE 180 mg/1 49738-668_1e73dc7d-9413-4ca9-9ed1-dcb84142e267 49738-668 HUMAN OTC DRUG smart sense nighttime cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20101203 OTC MONOGRAPH FINAL part341 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 49738-678_aea63931-5e13-4c50-ab30-842ca193961f 49738-678 HUMAN OTC DRUG Smart Sense Hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20130115 OTC MONOGRAPH FINAL part346 Kmart Corporation MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 49738-679_5d77b701-f252-42d0-a483-4f5fa4d8a324 49738-679 HUMAN OTC DRUG smart sense triple antibiotic Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20101106 OTC MONOGRAPH FINAL part333B Kmart Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 49738-685_8ea89b63-3e30-4c86-8fda-3939dfb8349d 49738-685 HUMAN OTC DRUG Smart Sense ibuprofen Ibuprofen LIQUID ORAL 20100520 ANDA ANDA074937 Kmart Corporation IBUPROFEN 100 mg/5mL 49738-688_1769507d-93af-4192-8d7f-6af4bc25a49d 49738-688 HUMAN OTC DRUG Smart Sense sinus relief Oxymetazoline HCl SPRAY NASAL 20110126 OTC MONOGRAPH FINAL part341 Kmart Corporation OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL 49738-692_377c752d-07ec-4501-8e20-588064cf5bc8 49738-692 HUMAN OTC DRUG smart sense cool heat Menthol, Methyl salicylate CREAM TOPICAL 20110724 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g 49738-693_22b2256e-8ee2-4542-b40e-a17ea0556e46 49738-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20090309 OTC MONOGRAPH NOT FINAL part334 Kmart Corporation MAGNESIUM CITRATE 1.745 g/29.6mL 49738-694_c9a2cae8-3eb1-473a-850b-68472524347d 49738-694 HUMAN OTC DRUG Anti-Aging Vitamin Complex 7-in-1 Broad Spectrum SPF15 Sunscreen Avobenzone, Octisalate, Octocrylene LOTION TOPICAL 20131110 OTC MONOGRAPH NOT FINAL part352 Kmart Corporation AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 g/100mL; g/100mL; g/100mL 49738-695_87eefa30-f538-4bf5-831f-214101412a31 49738-695 HUMAN OTC DRUG smart sense Allergy Relief Diphenhydramine Hydrochloride TABLET ORAL 20140220 OTC MONOGRAPH FINAL part341 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49738-699_4d008d62-815e-46ff-aebc-0101abe549ab 49738-699 HUMAN OTC DRUG Smart Sense Dual Action Complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20140429 ANDA ANDA077355 Kmart Corporation CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 49738-700_e5a1da0e-9981-43d7-b23d-a3b9b6aad9d9 49738-700 HUMAN OTC DRUG smart sense anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20110109 ANDA ANDA075232 Kmart Corporation LOPERAMIDE HYDROCHLORIDE 2 mg/1 49738-702_feafc7dd-d41a-451e-969b-54b309b5b072 49738-702 HUMAN OTC DRUG Smart Sense Topical Analgesic Skin Protectant Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20131213 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 49738-715_bbf88e3f-8c8f-4465-87c3-5022288e446e 49738-715 HUMAN OTC DRUG Kmart Corporation Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Kmart Corporation POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 49738-720_f0da44e2-affd-4e9b-99e6-0c6c3d0444df 49738-720 HUMAN OTC DRUG IMAGE ESSENTIALS Antibacterial TRICLOSAN SOAP TOPICAL 20101109 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .115 mL/100mL 49738-721_fa936a1a-6158-42de-8201-0814f33366c1 49738-721 HUMAN OTC DRUG IMAGE ESSENTIALS TRICLOSAN LIQUID TOPICAL 20120221 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .115 mL/100mL 49738-722_6b1a5c79-8629-491a-bf0f-e9e7b1a7d738 49738-722 HUMAN OTC DRUG IMAGE ESSENTIALS ANTIBACTERIAL HAND GOLD TRICLOSAN LIQUID TOPICAL 20141117 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN 1.5 mg/mL 49738-723_678282d8-1ba3-4447-b87d-2caf2978f632 49738-723 HUMAN OTC DRUG IMAGE ESSENTIALS ANTIBACTERIAL HAND GOLD TRICLOSAN LIQUID TOPICAL 20141117 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN 1.5 mg/mL 49738-723_8b60047f-d36d-496c-b266-8f731a565e45 49738-723 HUMAN OTC DRUG IMAGE ESSENTIALS ANTIBACTERIAL HAND GOLD TRICLOSAN LIQUID TOPICAL 20140826 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN 1.5 mg/mL 49738-724_721d0cf2-d489-4bc9-a1d5-4058853af77a 49738-724 HUMAN OTC DRUG smart sense allergy and congestion relief Pseudoephedrine sulfate, Loratadine TABLET, FILM COATED ORAL 20101223 ANDA ANDA075989 Kmart Corporation LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 49738-731_3ebef41a-c050-4b0e-bd1b-de9e7ad210fe 49738-731 HUMAN OTC DRUG Image Essentials Gold Triclocarban SOAP TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part333A Kmart Corporation TRICLOCARBAN .3 g/100g 49738-733_1ac7a403-8499-44e1-b2f0-76e37975ac7b 49738-733 HUMAN OTC DRUG Smart Sense NightTime DayTime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130823 OTC MONOGRAPH FINAL part341 Kmart Corporation 49738-737_a85cadbf-719a-4dab-a01d-74bb98e09902 49738-737 HUMAN OTC DRUG smart sense miconazole 1 Miconazole nitrate KIT 20100615 ANDA ANDA079114 Kmart Corporation 49738-742_bbbb5c28-08ac-49b1-986f-7a2f33b596ad 49738-742 HUMAN OTC DRUG smart sense naproxen sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20110622 NDA NDA021920 Kmart Corporation NAPROXEN SODIUM 220 mg/1 49738-746_4307e83a-65a1-4084-ac98-ae31f820140f 49738-746 HUMAN OTC DRUG Image Essentials Daily Illuminating Moisturizer Broad Spectrum SPF 15 Sunscreen Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 KMART Corporation AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 g/100g; g/100g; g/100g 49738-758_beda04a6-6de9-4d5a-b34b-431f37aa2012 49738-758 HUMAN OTC DRUG Smart Sense Infants Pain Relief Acetaminophen LIQUID ORAL 20131217 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 160 mg/5mL 49738-763_75f1882f-dd75-4b24-8d12-9e3d31f1b56b 49738-763 HUMAN OTC DRUG Smart Sense Severe Cold and Flu NightTime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl LIQUID ORAL 20131122 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 49738-771_c88822bb-087b-4318-bcfa-83d6bdc7839f 49738-771 HUMAN OTC DRUG Smart Sense Enamel Guard Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Kmart Corporation POTASSIUM NITRATE; SODIUM FLUORIDE 5; 1.5 g/g; g/g 49738-798_02f7e7af-2879-4f27-b91a-f9f7e5514c5c 49738-798 HUMAN OTC DRUG Image Essentials Hair Regrowth Treatment Minoxidil SOLUTION TOPICAL 20110712 ANDA ANDA075598 Kmart Corporation MINOXIDIL 3 g/60mL 49738-799_fb38b3aa-2643-4e6e-9a76-dc8bb28cec3c 49738-799 HUMAN OTC DRUG Smart Sense tussin dm max adult Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20100624 OTC MONOGRAPH FINAL part341 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 49738-801_454305d0-2701-4ecd-ad32-95749f74dd48 49738-801 HUMAN OTC DRUG K-Mart SmartSense First Aid Contains 101 Pieces BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN KIT 20100511 OTC MONOGRAPH FINAL part333 K Mart 49738-802_075459e9-2adb-44b5-a8c6-99c05ff35a08 49738-802 HUMAN OTC DRUG K-Mart SmartSense First Aid Contains 303 Pieces BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOTROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN KIT 20100511 OTC MONOGRAPH FINAL part333 Kmart Corporation 49738-803_5b4c6df6-0b44-4437-9bef-29f52920e02c 49738-803 HUMAN OTC DRUG smart sense allergy relief Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20140821 ANDA ANDA076447 Kmart Corporation FEXOFENADINE HYDROCHLORIDE 180 mg/1 49738-805_b998c975-d779-4e2c-880a-472226215595 49738-805 HUMAN OTC DRUG Antibacterial Body Wash Triclosan LIQUID TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333E Kmart Corporation TRICLOSAN .15 mL/100mL 49738-807_01be21a3-cc7a-41b0-bd36-5d952a4d1709 49738-807 HUMAN OTC DRUG Smart Sense Cold Remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20110103 UNAPPROVED HOMEOPATHIC Kmart Corporation ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 49738-809_2bc66c35-d169-4fe8-95f6-77a17f257335 49738-809 HUMAN OTC DRUG smart sense antibiotic maximum strength Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20100927 OTC MONOGRAPH FINAL part333B Kmart Corporation NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 49738-811_9687ed77-5357-4f0e-b341-03636a58d593 49738-811 HUMAN OTC DRUG KMart Corporation Radiant White Fluoride PASTE, DENTIFRICE DENTAL 20140224 OTC MONOGRAPH FINAL part355 KMart Corporation SODIUM FLUORIDE .243 g/100g 49738-812_f6bb3c7a-442c-491a-9f63-be90315f38d5 49738-812 HUMAN OTC DRUG KMart Corporation Prisim White Fluoride PASTE, DENTIFRICE DENTAL 20140224 OTC MONOGRAPH FINAL part355 KMart Corporation SODIUM MONOFLUOROPHOSPHATE .76 g/100g 49738-816_c83a041c-2138-4ceb-9291-7d335ca6e9dd 49738-816 HUMAN OTC DRUG Smart Sense Hydrocortisone hydrocortisone CREAM TOPICAL 20100927 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE 1 g/100g 49738-822_3aa98960-7f59-4f0a-a243-ce811d137e75 49738-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 19960315 OTC MONOGRAPH FINAL part347 Kmart Corporation WITCH HAZEL 86 kg/100L 49738-825_8652a0dc-f4be-463a-87c3-7c9e24ad8685 49738-825 HUMAN OTC DRUG smart sense 7 day treatment Miconazole nitrate CREAM VAGINAL 20110210 ANDA ANDA074760 Kmart Corporation MICONAZOLE NITRATE 2 g/100g 49738-829_d4191404-dd67-4126-b5e2-f9e6f435fe2f 49738-829 HUMAN OTC DRUG smart sense pain relief pm extra strength Acetaminophen, Diphenhydramine HCl CAPSULE, COATED ORAL 20100709 OTC MONOGRAPH FINAL part338 Kmart Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 49738-846_78f6af3e-470e-44eb-91f2-dac99b3695ad 49738-846 HUMAN OTC DRUG Smart Sense Childrens Multi Symptom Cold Relief Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20140227 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 49738-857_2d019596-931f-4fea-9f48-4645595c6c98 49738-857 HUMAN OTC DRUG smart sense athletes foot antifungal Clotrimazole CREAM TOPICAL 20101119 OTC MONOGRAPH FINAL part333C Kmart Corporation CLOTRIMAZOLE 1 g/100g 49738-866_3ad96e60-fc4b-4d27-bdfc-1f153edacab3 49738-866 HUMAN OTC DRUG smart sense lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20110627 OTC MONOGRAPH FINAL part358G Kmart Corporation PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 49738-871_030aafb4-f498-46b0-baee-cac023426cfc 49738-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19960327 OTC MONOGRAPH NOT FINAL part333A Kmart Corp HYDROGEN PEROXIDE .3 kg/100L 49738-872_a3af087e-77e5-44d6-be20-64b8201ad259 49738-872 HUMAN OTC DRUG Smart Sense NightTime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20130430 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 49738-873_a0d6216d-af6e-4751-8cb8-36380da0e69e 49738-873 HUMAN OTC DRUG Smart Sense Nicotine Polacrilex Nicotine Polacrilex LOZENGE ORAL 20110509 ANDA ANDA077007 Kmart Corporation NICOTINE 4 mg/1 49738-886_babbba16-94ba-4b16-bf56-8c3ea333e065 49738-886 HUMAN OTC DRUG smart sense sinus congestion and pain day night Acetaminophen,Phenylephrine HCl, Chlorpheniramine maleate KIT 20111116 OTC MONOGRAPH FINAL part341 Kmart Corporation 49738-886_d1d56170-80f0-4e7c-9106-001263dff3cb 49738-886 HUMAN OTC DRUG smart sense sinus Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20110310 OTC MONOGRAPH FINAL part341 Kmart Corporation 49738-888_4c3e7c07-fac4-491c-a6d3-43278bfac887 49738-888 HUMAN OTC DRUG Smart Sense Zinc Cold Remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20140228 UNAPPROVED HOMEOPATHIC Kmart Corporation ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 49738-897_f5aef25d-90dc-4dba-bf4e-3d9ffa5a78d6 49738-897 HUMAN OTC DRUG smart sense ibuprofen Ibuprofen SUSPENSION ORAL 20100520 ANDA ANDA074937 Kmart Corporation IBUPROFEN 100 mg/5mL 49738-903_34247c37-ad8f-426b-9ed1-1664d98c3c9b 49738-903 HUMAN OTC DRUG smart sense multi symptom cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20101229 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 49738-906_0eb7ca60-fcef-427a-8c59-8cd4b8929c4e 49738-906 HUMAN OTC DRUG smart sense cold and allergy childrens phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20110331 OTC MONOGRAPH FINAL part341 Kmart Corporation BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 49738-908_c64870b2-5af8-496f-b3a2-b445ca76955a 49738-908 HUMAN OTC DRUG smart sense nighttime cold and flu relief multi symptom acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20110621 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 49738-913_2aeb5e45-9bc4-4aa2-bd10-d59da53b7fe8 49738-913 HUMAN OTC DRUG smart sense triacting Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20110126 OTC MONOGRAPH FINAL part341 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 49738-915_6ef5d67e-85cb-4a7f-96ca-e52d7b2c237a 49738-915 HUMAN OTC DRUG smart sense omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20110120 NDA NDA022032 Kmart Corporation OMEPRAZOLE 20 mg/1 49738-916_c59596ab-7971-42d4-87f1-fc558170ea3c 49738-916 HUMAN OTC DRUG smart sense miconazole 1 Miconazole nitrate KIT 20100615 ANDA ANDA079114 Kmart Corporation 49738-917_26b2bedd-2b6d-45e6-98a0-3fe437f4b239 49738-917 HUMAN OTC DRUG Smart Sense pain relief Acetaminophen CAPSULE, COATED ORAL 20110205 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 500 mg/1 49738-917_55717139-ef08-42da-980d-3c0d717a93ca 49738-917 HUMAN OTC DRUG smart sense pain relief Acetaminophen CAPSULE, COATED ORAL 20110722 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 500 mg/1 49738-927_bb0f601b-4a5e-4ab5-8255-4a3f3e25ebc3 49738-927 HUMAN OTC DRUG Maximum Strength Original Diaper Rash Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 KMART Corporation ZINC OXIDE 400 mg/g 49738-929_06303ef0-89c8-458c-84da-a6841fe376a6 49738-929 HUMAN OTC DRUG smart sense anti itch maximum strength Hydrocortisone Acetate OINTMENT TOPICAL 20101116 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE ACETATE 1 g/100g 49738-945_4236ae39-41d8-44a4-8efd-654e333c43b6 49738-945 HUMAN OTC DRUG Little Ones Petroleum Petrolatum JELLY TOPICAL 20121022 OTC MONOGRAPH FINAL part347 Kmart Corporation PETROLATUM 100 g/100g 49738-946_6f9e6c10-e0cf-46a3-a5f4-fb012d944eab 49738-946 HUMAN OTC DRUG smart sense infants pain and fever Acetaminophen LIQUID ORAL 20111020 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 160 mg/5mL 49738-950_51c64492-676a-49c8-a802-79163bf658da 49738-950 HUMAN OTC DRUG smart sense acid reducer Ranitidine TABLET, FILM COATED ORAL 20111122 ANDA ANDA091429 Kmart Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 49738-951_d863f36b-5d6d-486c-8fa8-48cf9c262bea 49738-951 HUMAN OTC DRUG Instant Hand sanitizer ALCOHOL GEL TOPICAL 20110513 OTC MONOGRAPH NOT FINAL part333A Kmart Corp ALCOHOL 65 kg/100L 49738-955_2db3cfd8-e8c5-4832-ba8d-c7a44256362b 49738-955 HUMAN OTC DRUG smart sense lice treatment Permethrin LOTION TOPICAL 20110301 ANDA ANDA076090 Kmart Corporation PERMETHRIN 1 mg/100mL 49738-958_6ac0dbbe-9ccf-46d8-8397-6d9564473ebf 49738-958 HUMAN OTC DRUG Smart Sense Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130805 ANDA ANDA091135 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 49738-959_e7b21646-fbc6-4cb6-8395-ef3a14fcd831 49738-959 HUMAN OTC DRUG Smart Sense Childrens Pain Relief Acetaminophen LIQUID ORAL 20130805 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 160 mg/5mL 49738-964_974bb5a3-50f5-4967-8294-ab9fbc9afbc2 49738-964 HUMAN OTC DRUG smart sense flu and severe cold and cough nighttime Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20101115 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 49738-966_1a5e4ca2-bdfe-48ff-b8fa-75d740d2c87a 49738-966 HUMAN OTC DRUG smart sense arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101014 ANDA ANDA075077 Kmart Corporation ACETAMINOPHEN 650 mg/1 49738-970_c2f4ec17-c56f-4dc6-9be5-f71760a34383 49738-970 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130401 OTC MONOGRAPH FINAL part336 SMART SENSE (Kmart) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49738-973_ab42e992-1f2d-417e-a4c7-5d483cd602f6 49738-973 HUMAN OTC DRUG smart sense anti itch hydrocortisone CREAM TOPICAL 20100927 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE 1 g/100g 49738-974_6dee93b6-0658-43e5-a2cc-821587109cfb 49738-974 HUMAN OTC DRUG Smart Sense Childrens Cetirizine Hydrochloride cetirizine hydrochloride LIQUID ORAL 20130207 ANDA ANDA090254 Kmart Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL 49738-975_16e31176-e605-4535-930a-b60d1cde32fb 49738-975 HUMAN OTC DRUG smart sense pain relief Acetaminophen TABLET ORAL 20100722 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 500 mg/1 49738-982_e41d1c88-489a-47b2-be54-ec0a3dccc78d 49738-982 HUMAN OTC DRUG smart sense 3 day treatment vaginal antifungal Miconazole nitrate KIT 20110516 ANDA ANDA076357 Kmart Corporation 49738-987_0069e930-4460-4cb7-afb4-5ba3ff1002d8 49738-987 HUMAN OTC DRUG smart sense cold and cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20101229 OTC MONOGRAPH FINAL part341 Kmart Corporation BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 49738-990_236797f0-40bf-4474-8aa5-433741a55207 49738-990 HUMAN OTC DRUG smart sense nighttime - acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid LIQUID ORAL 20101207 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 49741-1002_1011e46b-cf9e-459d-84ae-003a70d976e4 49741-1002 HUMAN OTC DRUG MedActive Patient Friendly Stannous Fluoride KIT 20100224 OTC MONOGRAPH FINAL part355 MedActive Oral Pharmaceuticals, LLC. 49741-1003_76e5437a-85b7-4607-89fa-14f828450580 49741-1003 HUMAN OTC DRUG MedActive Patient Friendly Stannous Fluoride KIT 20100224 OTC MONOGRAPH FINAL part355 MedActive Oral Pharmaceuticals, LLC. 49741-1004_3d31933b-1e53-49dd-80ad-038b8a80e4e7 49741-1004 HUMAN OTC DRUG MedActive Patient Friendly Stannous Fluoride KIT 20100224 OTC MONOGRAPH FINAL part355 MedActive Oral Pharmaceuticals, LLC. 49742-1001_8089b888-7b55-44ea-a12a-6ab827edf4e8 49742-1001 HUMAN OTC DRUG Skin-ion ARBUTIN, ADENOSINE, GLYCERIN SPRAY TOPICAL 20100101 OTC MONOGRAPH FINAL part347 WAKO Korea Corp ADENOSINE; ARBUTIN; GLYCERIN .016; .8; .8 mL/40mL; mL/40mL; mL/40mL 49743-3001_7da063a7-3c4f-4626-b1c9-70bfd6488314 49743-3001 HUMAN OTC DRUG SelectHealth Tussin DM Guaifenesin LIQUID ORAL 20110901 OTC MONOGRAPH FINAL part341 Axcentria Pharmaceuticals, LLC. GUAIFENESIN 100 mg/5mL 49743-3003_dfcebe7c-7215-47cf-9e2c-9822439eb207 49743-3003 HUMAN OTC DRUG Select Health Allergy Relief Cherry Diphenhydramine Hydrochloride LIQUID ORAL 20110901 OTC MONOGRAPH FINAL part341 Axcentria Pharmaceuticals, LLC. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 49743-3047_d763cf0b-a67f-490c-852d-ce795fa6e62f 49743-3047 HUMAN OTC DRUG Mineral Oil, Petrolatum and Phenylephrine HCl mineral oil, petrolatum, phenylephrine HCl OINTMENT TOPICAL 20130628 OTC MONOGRAPH FINAL part346 Axcentria Pharmaceuticals, LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 741; 2.5 mg/g; mg/g; mg/g 49744-0001_487ab559-8344-4b04-9505-51bce0641ccd 49744-0001 HUMAN OTC DRUG Herplex not applicable TABLET ORAL 20140722 UNAPPROVED HOMEOPATHIC Paradigm, Inc. CHRYSOPOGON ZIZANIOIDES ROOT; CLEMATIS RECTA FLOWERING TOP; DAPHNE MEZEREUM BARK; PHYTOLACCA AMERICANA ROOT; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12; 30; 30; 12; 12 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 49757-001_bba6dbef-2c69-41cc-95d3-921e1e366317 49757-001 HUMAN OTC DRUG Rocky Mountain Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20120427 OTC MONOGRAPH FINAL part352 Rocky Mountain Sunscreen AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 10; 7.5; 5; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 49757-002_81ad9384-1c16-48c4-ab6d-9b8657c61bd3 49757-002 HUMAN OTC DRUG Rocky Mountain KIDS Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20120427 OTC MONOGRAPH FINAL part352 Rocky Mountain Sunscreen AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 10; 7.5; 5; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 49758-100_15cd1ba5-1174-4a5f-aeea-a5c7c59d0592 49758-100 HUMAN OTC DRUG Dermabon Psoriasis and Dandruff Soap COAL TAR SOAP TOPICAL 20091001 OTC MONOGRAPH FINAL part358 Jose Maria Licona Saenz COAL TAR 2.13 g/100g 49762-450_41cd1174-13f5-4a50-8955-9f1cf9fc398e 49762-450 HUMAN OTC DRUG Earwax Removal Earwax Removal LIQUID AURICULAR (OTIC) 20080831 OTC MONOGRAPH FINAL part344 Apothecary Products, LLC CARBAMIDE PEROXIDE 6.5 mg/100mL 49762-453_391897b2-7553-4c30-b756-9ac7e7b18e27 49762-453 HUMAN OTC DRUG Earwax Removal Aid Earwax Removal Aid LIQUID AURICULAR (OTIC) 20100831 OTC MONOGRAPH FINAL part344 Apothecary Products, LLC CARBAMIDE PEROXIDE 6.5 mg/100mL 49765-310_d86f7aa6-1cb2-4c8d-829a-f3de5eb48c81 49765-310 HUMAN OTC DRUG ARTEMIS Alcohol-Free Antiseptic Foam Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20110224 OTC MONOGRAPH FINAL part333E Artemis Bio-Solutions Inc BENZALKONIUM CHLORIDE .13 mL/100mL 49765-410_5181a4d6-c9c0-4f4e-8662-b3193e5f28e6 49765-410 HUMAN OTC DRUG ARTEMIS Alcohol-Free Antiseptic Foam Hand BENZALKONIUM CHLORIDE SOAP TOPICAL 20110224 OTC MONOGRAPH FINAL part333E Artemis Bio-Solutions Inc BENZALKONIUM CHLORIDE .13 mL/100mL 49766-2858_4e77ecca-c5c2-403d-a9d1-4e30ab1a6aca 49766-2858 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070225 UNAPPROVED MEDICAL GAS Max's Breathe Easy Gases & Supplies, Inc. OXYGEN 99 L/100L 49771-002_078c847d-5716-4b3c-9b31-a75cfb2669d0 49771-002 HUMAN PRESCRIPTION DRUG Mitosol mitomycin KIT URETERAL 20120208 NDA NDA022572 Mobius Therapeutics LLC 49778-001_ff818ac6-b10e-4b24-b435-f2a75f290f89 49778-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090501 UNAPPROVED MEDICAL GAS American Welding & Gas OXYGEN 992 mL/1000mL 49778-002_11ca393a-47aa-4ee5-8d3b-61d818bdfe63 49778-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090501 UNAPPROVED MEDICAL GAS American Welding & Gas OXYGEN 992 L/1000L 49778-003_cb6fda01-23d6-4358-8bc8-37495c829949 49778-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20090501 UNAPPROVED MEDICAL GAS American Welding & Gas NITROGEN 99 mL/100mL 49778-004_f4577f6b-6e29-4299-83e9-d02133ce44b8 49778-004 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20090501 UNAPPROVED MEDICAL GAS American Welding & Gas NITROGEN 99 L/100L 49778-005_8f3fc95a-ae07-4d4e-b6e3-5309101a857b 49778-005 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090501 UNAPPROVED MEDICAL GAS American Welding & Gas OXYGEN 992 L/1000L 49781-010_c41d03d1-0c72-4841-a332-d2a8e952f928 49781-010 HUMAN OTC DRUG leader childrens pain and fever Acetaminophen SUSPENSION ORAL 20100303 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL 49781-011_cfd01332-511a-4191-b13d-e294176c86ba 49781-011 HUMAN OTC DRUG Cold Head Congestion Nighttime Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl CAPSULE ORAL 20050721 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 49781-012_ecc5e0ef-d46a-425f-a0f7-f996666c5a48 49781-012 HUMAN OTC DRUG LEADER Cough Drops Menthol Flavor MENTHOL LOZENGE ORAL 20131125 OTC MONOGRAPH FINAL part341 Cardinal Health MENTHOL 5.4 mg/1 49781-013_b2043aaf-5c61-4583-af25-3e4ef8f682af 49781-013 HUMAN OTC DRUG LEADER Cough Drops Cherry Flavor MENTHOL LOZENGE ORAL 20131125 OTC MONOGRAPH FINAL part341 Cardinal Health MENTHOL 5.8 mg/1 49781-014_f491ab2f-1245-439a-b50b-bb106fb8caa2 49781-014 HUMAN OTC DRUG LEADER Cough Drops Honey Lemon MENTHOL LOZENGE ORAL 20131125 OTC MONOGRAPH FINAL part341 Cardinal Health MENTHOL 7.5 mg/1 49781-015_12fac8f4-440f-4fc0-8811-aa666655819d 49781-015 HUMAN OTC DRUG leader childrens pain and fever Acetaminophen SUSPENSION ORAL 19900515 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL 49781-016_705da66e-ba8b-4522-8a0c-e3a481add0c3 49781-016 HUMAN OTC DRUG leader childrens pain and fever Acetaminophen SUSPENSION ORAL 19970622 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL 49781-017_41930241-c72f-4c6b-a2d3-61ffb40b0f3e 49781-017 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20120301 OTC MONOGRAPH NOT FINAL part334 Cardinal Health (Leader) 49781 DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 49781-018_49323185-81a0-4fc6-81eb-db93cf076551 49781-018 HUMAN OTC DRUG Leader Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 19970512 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL 49781-019_48288c3a-4929-462b-a79a-0e9ae9db47d9 49781-019 HUMAN OTC DRUG Leader ClearLax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091026 ANDA ANDA090685 Cardinal Health POLYETHYLENE GLYCOL 3350 17 g/17g 49781-020_2c2aa8f6-4651-4c86-9305-ec044c65bc04 49781-020 HUMAN OTC DRUG Leader Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20020508 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL 49781-021_6d861b72-c96e-4cde-8203-f21c9ebd3c0a 49781-021 HUMAN OTC DRUG leader childrens ibuprofen Ibuprofen SUSPENSION ORAL 20140305 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL 49781-022_126b09fe-11f8-4562-8afb-e755cff09520 49781-022 HUMAN OTC DRUG Leader Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20020425 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL 49781-025_621ee421-4331-475b-bc2a-d3474d7972e9 49781-025 HUMAN OTC DRUG Leader Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 19900415 OTC MONOGRAPH FINAL part335 Cardinal Health BISMUTH SUBSALICYLATE 525 mg/30mL 49781-026_4943c1d0-dd17-4785-99bd-bf3dd78461f0 49781-026 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130925 ANDA ANDA201745 Cardinal Health RANITIDINE HYDROCHLORIDE 75 mg/1 49781-027_5fe5c89e-ca10-4981-9899-e42e2884628c 49781-027 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20130925 ANDA ANDA200536 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 49781-028_85cf8bec-fc99-48da-8efc-c6ad0915300d 49781-028 HUMAN OTC DRUG leader lice treatment Permethrin LOTION TOPICAL 20110615 ANDA ANDA076090 Cardinal Health PERMETHRIN 1 mg/100mL 49781-032_a83dc654-73f5-437c-9b0f-e0ff535d05d7 49781-032 HUMAN OTC DRUG Leader Lubricant Eye Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20140218 OTC MONOGRAPH FINAL part349 Cardinal Health CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL 49781-034_3ea7049c-d10b-4bcf-a9a3-79e0a690247c 49781-034 HUMAN OTC DRUG Leader Aller Ease fexofenadine hcl TABLET, FILM COATED ORAL 20140205 ANDA ANDA076447 Cardinal Health FEXOFENADINE HYDROCHLORIDE 180 mg/1 49781-036_422363bd-3332-421e-9ff4-de3b38718fd1 49781-036 HUMAN OTC DRUG Leader Mucus Relief Severe Congestion and Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20131030 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 49781-037_924de479-41f6-4ff6-b17c-d069edcc9d6f 49781-037 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH NOT FINAL part334 Cardinal Health (Leader) 49781 DOCUSATE SODIUM 100 mg/1 49781-038_c6388cd1-6a9b-467a-ad21-49025bb3a422 49781-038 HUMAN OTC DRUG Leader Mucus Relief Cold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20131030 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 49781-039_8cd73fc2-6f74-4058-9aa9-7dd0c139b74a 49781-039 HUMAN OTC DRUG Leader Mucus Relief Cold and Sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20131030 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 49781-040_dcb06f04-9b46-4116-88ba-c471ec24ca00 49781-040 HUMAN OTC DRUG Leader Milk of Magnesia Magnesium hydroxide LIQUID ORAL 20140123 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MAGNESIUM HYDROXIDE 1200 mg/15mL 49781-041_ba98fdaa-8d68-4b7a-9c3f-5fe250a4c577 49781-041 HUMAN OTC DRUG Leader Original Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20130829 OTC MONOGRAPH FINAL part341 Cardinal Health OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mg 49781-042_293502d0-bc49-471b-a206-a8135912064d 49781-042 HUMAN OTC DRUG Leader Extra Moisturizing Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20130829 OTC MONOGRAPH FINAL part341 Cardinal Health OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mg 49781-043_53ccf71f-0f08-4a08-92ea-93225d2a3f32 49781-043 HUMAN OTC DRUG LEADER Sugar Free Cough Drops Black Cherry MENTHOL LOZENGE ORAL 20131125 OTC MONOGRAPH FINAL part341 Cardinal Health MENTHOL 5.8 mg/1 49781-044_eb136fde-c907-47a0-bfb5-aaa74a7ad863 49781-044 HUMAN OTC DRUG Chocolated Laxative Sennosides Stimulant Laxative TABLET, CHEWABLE ORAL 20140401 OTC MONOGRAPH NOT FINAL part334 Cardinal Health (Leader) SENNOSIDES 15 mg/1 49781-045_ad0edecb-408c-4f30-b290-41c886883488 49781-045 HUMAN OTC DRUG Vapor Inhaler Levmetamfetamine Nasal Decongestant INHALANT NASAL 20140301 OTC MONOGRAPH FINAL part341 Cardinal Health (Leader) LEVMETAMFETAMINE 50 mg/1 49781-046_8939d594-0ac6-4ce7-aef9-8b6cf3eb0875 49781-046 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20120625 ANDA ANDA079096 Cardinal Health (Leader) 49781 NAPROXEN SODIUM 220 mg/1 49781-047_1030edf0-5aaa-43b8-b5ef-bf6f30f65e65 49781-047 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20120625 ANDA ANDA079096 Cardinal Health (Leader) 49781 NAPROXEN SODIUM 220 mg/1 49781-048_b58e1d47-ca5f-4556-8cd1-3dc80b046567 49781-048 HUMAN OTC DRUG Leader SleepTime Diphenhydramine HCl LIQUID ORAL 20131011 OTC MONOGRAPH FINAL part338 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 49781-049_3ec1da69-ff71-4ef3-8929-9a6800bb5329 49781-049 HUMAN OTC DRUG Leader SleepTime Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20131202 OTC MONOGRAPH FINAL part338 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49781-050_03d7d7b8-00ff-46af-9e28-4f046eb9100d 49781-050 HUMAN OTC DRUG Leader Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 20140220 OTC MONOGRAPH FINAL part335 Cardinal Health BISMUTH SUBSALICYLATE 1050 mg/30mL 49781-051_abf770c7-321a-4ef7-bd65-cee203f944a2 49781-051 HUMAN OTC DRUG Leader Acid Control Ranitidine TABLET, FILM COATED ORAL 20080220 ANDA ANDA091429 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 49781-052_50686c5b-efe7-4caf-91a7-705eddcf8b09 49781-052 HUMAN OTC DRUG Leader Day Time acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20131121 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 49781-053_d7399b61-4f8a-4f6f-8771-315c6e1f2ad9 49781-053 HUMAN OTC DRUG Leader Childrens Mucus Relief Multi Symptom Cold dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20131122 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 49781-054_44e47ce1-9491-4a80-a47f-388a88cf2f57 49781-054 HUMAN OTC DRUG leader nite time severe cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl LIQUID ORAL 20131121 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 49781-055_82cb8b83-8408-49e6-93d7-62a4644fd31b 49781-055 HUMAN OTC DRUG Leader Day Time acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20131121 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 49781-056_61a19c0f-ac4f-4424-a2af-f3a01972c48f 49781-056 HUMAN OTC DRUG Leader Severe Sinus Congestion Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20131121 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 49781-057_f23d323b-0eb4-4af4-aaf4-428030dbc373 49781-057 HUMAN OTC DRUG Leader Sinus and Cold-D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20131105 ANDA ANDA076518 Cardinal Health NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 49781-058_17e6e28a-f156-4777-8bcb-24f78ef56c32 49781-058 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl TABLET ORAL 20110928 OTC MONOGRAPH FINAL part336 Cardinal Health (Leader) 49781 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49781-059_48f56652-d4f7-4a8c-b1dd-ee193c32dd56 49781-059 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Cardinal Health (Leader) 49781 DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 49781-060_5aa5c5ae-d23f-4d56-9c40-6a81d9316978 49781-060 HUMAN OTC DRUG Leader Adult Tussin Mucus Plus Chest Congestion Guaifenesin SYRUP ORAL 19900415 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN 200 mg/10mL 49781-061_cfa6b8f7-d890-44ee-b27e-c0c538042461 49781-061 HUMAN OTC DRUG Leader Loperamide Hydrochloride loperamide HCl SUSPENSION ORAL 20140423 ANDA ANDA091292 Cardinal Health LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 49781-062_b1d78d9a-81d6-4f24-a076-f627f748cdab 49781-062 HUMAN OTC DRUG Leader Pain Relief 8 HR Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140123 ANDA ANDA075077 Cardinal Health ACETAMINOPHEN 650 mg/1 49781-063_f70fcaa4-da00-47d3-872c-d6220090c02d 49781-063 HUMAN OTC DRUG Leader Arthritis Pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140123 ANDA ANDA075077 Cardinal Health ACETAMINOPHEN 650 mg/1 49781-064_ba06a67a-854b-4f50-bbdd-3fc96529c540 49781-064 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20140531 ANDA ANDA074164 Cardinal Health (Leader) MICONAZOLE NITRATE 2 g/100g 49781-065_018054f6-adcb-450b-b631-dab1c1b1002c 49781-065 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 49781-067_7722e4ad-7fd9-4906-8abf-d2528cd027c7 49781-067 HUMAN OTC DRUG Leader Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20140207 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 49781-071_525cc513-9945-43fe-af1b-e168d562a1db 49781-071 HUMAN OTC DRUG Leader Congestion Relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20140915 ANDA ANDA203200 Cardinal Health IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 49781-073_6248d187-1991-4491-8cea-e45a662fa5b8 49781-073 HUMAN OTC DRUG LEADER Triple Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE STICK TOPICAL 20140320 OTC MONOGRAPH FINAL part333B Cardinal Health BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 49781-074_77c0cc5a-8a5f-4bea-8939-b66ea2ebd88c 49781-074 HUMAN OTC DRUG Leader Nite Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140123 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 49781-075_b8c16af4-16f0-498b-8f3e-3c6f7f1edf48 49781-075 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140113 ANDA ANDA077958 Cardinal Health KETOTIFEN FUMARATE .35 mg/mL 49781-077_424b7649-6c84-4add-b553-b35d7fc70511 49781-077 HUMAN OTC DRUG Leader Hemorrholidal Mineral Oil, Petrolatum, Phenylephrine Hydrochloride OINTMENT TOPICAL 20131210 OTC MONOGRAPH FINAL part346 Cardinal Health MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 749; 2.5 mg/g; mg/g; mg/g 49781-078_c340fbc9-bf97-462b-a777-b10cbbbbeab4 49781-078 HUMAN OTC DRUG Allergy Eye Drops Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140113 ANDA ANDA077958 Cardinal Health KETOTIFEN FUMARATE .35 mg/mL 49781-079_908fe78a-54f5-46d6-86db-38813937444c 49781-079 HUMAN OTC DRUG Leader Acid Control Ranitidine TABLET, FILM COATED ORAL 20140311 ANDA ANDA091429 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 49781-080_54e8ce60-7c76-440f-b6e1-0860d99f36c9 49781-080 HUMAN OTC DRUG Pediatric Glycerin Laxative GLYCERIN SUPPOSITORY RECTAL 20140401 OTC MONOGRAPH NOT FINAL part334 Cardinal Health, Inc. GLYCERIN 1 g/1 49781-081_7a5e0b45-5bfc-4a24-a25e-d71fafbaf9ac 49781-081 HUMAN OTC DRUG Adult Glycerin Laxative GLYCERIN SUPPOSITORY RECTAL 20140401 OTC MONOGRAPH NOT FINAL part334 Cardinal Health, Inc. GLYCERIN 2 g/1 49781-083_2b839fb3-6dd4-42c2-ba99-fdaa1272cd3b 49781-083 HUMAN OTC DRUG Leader Extra Strength Medicated Pain Relief Patch Menthol PATCH TOPICAL 20140325 OTC MONOGRAPH NOT FINAL part348 Cardinal Health MENTHOL 50 mg/g 49781-084_8435bba9-abf7-473a-88b7-a29c00592c3c 49781-084 HUMAN OTC DRUG Leader Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 20140920 OTC MONOGRAPH FINAL part343 CARDINAL HEALTH ASPIRIN 81 mg/1 49781-086_c578b67f-aeef-4454-8a28-f6c7b31813dd 49781-086 HUMAN OTC DRUG leader acid reducer complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20140212 ANDA ANDA077355 Cardinal Health CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 49781-087_1fec33c5-a6ca-46e9-8559-fa429eb09cea 49781-087 HUMAN OTC DRUG Leader Ibuprofen 200 Ibuprofen TABLET ORAL 20140723 OTC MONOGRAPH NOT FINAL part343 Cardinal Health IBUPROFEN 200 mg/1 49781-088_93eb0033-b25c-4e1f-8027-cd92e18fc8a2 49781-088 HUMAN OTC DRUG Leader Extra Strength Pain Relief Acetaminophen TABLET ORAL 20140823 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 500 mg/1 49781-089_6f421dda-eed1-41bd-98f2-ffa2fb41f6ec 49781-089 HUMAN OTC DRUG leader loperamide Loperamide Hydrochloride SUSPENSION ORAL 20140530 ANDA ANDA091292 Cardinal Health LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 49781-090_639b8c3b-ffe1-445f-9361-6b49f39df480 49781-090 HUMAN OTC DRUG Leader Glycerin, Petrolatum, Phenylephrine Hydrochloride and Pramoxine Hydrochloride CREAM RECTAL 20140428 OTC MONOGRAPH FINAL part346 Cardinal Health GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 144; 150; 2.5; 10 mg/L; mg/L; mg/L; mg/L 49781-091_5eaa2fc8-71c9-4141-bc01-6a44bac63c2f 49781-091 HUMAN OTC DRUG Leader phenylephrine hydrochloride and witch hazel CREAM RECTAL 20140428 OTC MONOGRAPH FINAL part346 Cardinal Health PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL 2.5; 500 mg/L; mg/L 49781-092_9ffa8aaf-3afe-4faf-9812-f822e7a7c98d 49781-092 HUMAN OTC DRUG Leader Anti-Itch Maximum Strength Benzocaine and Resorcinol CREAM TOPICAL 20130519 OTC MONOGRAPH FINAL part346 Cardinal Health BENZOCAINE; RESORCINOL 200; 30 mg/g; mg/g 49781-093_ae7e38c3-c81c-48ea-961d-39cefef93131 49781-093 HUMAN OTC DRUG Leader Anti-Itch Regular Strength Benzocaine and Resorcinol CREAM TOPICAL 20140519 OTC MONOGRAPH FINAL part346 Cardinal Health BENZOCAINE; RESORCINOL 50; 20 mg/g; mg/g 49781-094_9a159f37-c369-493d-9d4b-fedf6a4f2280 49781-094 HUMAN OTC DRUG Leader Aspirin Aspirin TABLET, CHEWABLE ORAL 20140920 OTC MONOGRAPH FINAL part343 CARDINAL HEALTH ASPIRIN 81 mg/1 49781-095_688f138a-45d7-477f-988b-fb991ece1d4f 49781-095 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20140920 OTC MONOGRAPH FINAL part343 CARDINAL HEALTH ASPIRIN 325 mg/1 49781-096_761b3a57-a538-4698-a09d-2917a29081b5 49781-096 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20140920 OTC MONOGRAPH FINAL part343 CARDINAL HEALTH ASPIRIN 325 mg/1 49781-097_c65565de-6077-4c00-b18a-21c24ec88e7c 49781-097 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20140920 OTC MONOGRAPH FINAL part343 CARDINAL HEALTH ASPIRIN 81 mg/1 49781-098_be578da8-778a-434e-8528-1d54deb037a3 49781-098 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140731 OTC MONOGRAPH NOT FINAL part356 Cardinal Health (Leader) 49781 PHENOL 1.4 g/100mL 49781-099_f5ace019-3ccd-4d73-98d0-e8eb300ce087 49781-099 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ALCOHOL 70 mL/100mL 49781-100_3b82c438-2272-466b-a5e0-34bfe6c2c6b4 49781-100 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140731 ANDA ANDA091353 Cardinal Health (Leader) 49781 NAPROXEN SODIUM 220 mg/1 49781-101_37be6747-1ad2-405b-9e55-67e4b91c0626 49781-101 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140731 ANDA ANDA091353 Cardinal Health (Leader) 49781 NAPROXEN SODIUM 220 mg/1 49781-102_631c5a65-0a5c-4196-a48f-3a6cb9055431 49781-102 HUMAN OTC DRUG Leader Nicotine Nicotine Polacrilex LOZENGE ORAL 20141110 ANDA ANDA203690 Cardinal Health NICOTINE 4 mg/1 49781-103_112a11c3-efee-4e99-b4d9-3818564e9c2e 49781-103 HUMAN OTC DRUG Leader Nicotine Nicotine Polacrilex LOZENGE ORAL 20141110 ANDA ANDA203690 Cardinal Health NICOTINE 2 mg/1 49781-104_52141d25-84a3-4af0-b51c-b88af034f58b 49781-104 HUMAN OTC DRUG Leader Pain Reliever Acetaminophen TABLET ORAL 20140519 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 325 mg/1 49781-106_1d219885-77b2-4774-ba11-ddc7e0b488cb 49781-106 HUMAN OTC DRUG leader all day allergy Cetirizine Hydrochloride TABLET ORAL 20140604 ANDA ANDA078336 Cardinal Health CETIRIZINE HYDROCHLORIDE 10 mg/1 49781-107_b38f77a4-7bd7-40ca-8590-6e002692d591 49781-107 HUMAN OTC DRUG Leader Allergy Relief Loratadine TABLET ORAL 20140702 ANDA ANDA076301 Cardinal Health LORATADINE 10 mg/1 49781-108_c7238549-4eb4-4603-9f70-f2b793b54d97 49781-108 HUMAN OTC DRUG LEADER Hydrogen Peroxide Wipes HYDROGEN PEROXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part333A Cardinal Health HYDROGEN PEROXIDE 3 g/100g 49781-109_c3384ddd-7cc7-4c7e-8377-eef944f55fe8 49781-109 HUMAN OTC DRUG LEADER ISOPROPYL Alcohol Wipes ISOPROPYL ALCOHOL LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL 70 g/100g 49781-111_b5cce596-b285-4cf9-a5c8-1bdeadfc245b 49781-111 HUMAN OTC DRUG Leader Lip Treatment Petrolatum GEL TOPICAL 20130502 OTC MONOGRAPH FINAL part347 Cardinal Health (Leader) PETROLATUM 99.98 mg/g 49781-112_64c42b1f-db62-44d5-903f-227efb23e93d 49781-112 HUMAN OTC DRUG Leader Medicated Lip Balm Petrolatum STICK TOPICAL 20130401 OTC MONOGRAPH FINAL part347 Cardinal Health (Leader) PETROLATUM 41 mg/g 49781-113_c6a703c8-d95b-409a-9de9-cbdbab1c9d5f 49781-113 HUMAN OTC DRUG Restfully Sleep Diphenhydramine HCl TABLET ORAL 20000610 OTC MONOGRAPH FINAL part338 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49781-114_79a068f3-6776-46d6-b62e-3ac7bcbcc3a4 49781-114 HUMAN OTC DRUG Salicylic Acid One Step Clear Wart Remover PATCH TOPICAL 20100201 OTC MONOGRAPH FINAL part358B Cardinal Health SALICYLIC ACID 40 mg/141 49781-115_e4484f45-e25e-455c-9dc2-de4f6c64d8f3 49781-115 HUMAN OTC DRUG Salicylic Acid Liquid Wart Remover LIQUID TOPICAL 20011001 OTC MONOGRAPH FINAL part358F Cardinal Health SALICYLIC ACID .17 g/g 49781-116_ba766623-24a4-4100-a281-c206121f180e 49781-116 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20100201 OTC MONOGRAPH FINAL part358F Cardinal Health SALICYLIC ACID 40 mg/41 49781-117_5f0e50a9-9481-4471-90e1-27006e5c75cb 49781-117 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20100201 OTC MONOGRAPH FINAL part358F Cardinal Health SALICYLIC ACID 40 mg/91 49781-118_3e30b54a-3086-48f7-bb70-a538be469e75 49781-118 HUMAN OTC DRUG Salicylic Acid Liquid Corn and Callus Remover LIQUID TOPICAL 20041001 OTC MONOGRAPH FINAL part358F Cardinal Health SALICYLIC ACID .17 g/g 49781-119_c3c3828a-4b00-4fcc-972b-b6372510f5a0 49781-119 HUMAN OTC DRUG Leader Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20140930 OTC MONOGRAPH FINAL part331 Cardinal Health CALCIUM CARBONATE 1000 mg/1 49781-120_f7435010-973f-4783-b34e-634463a8ab90 49781-120 HUMAN OTC DRUG leader antacid calcium carbonate TABLET, CHEWABLE ORAL 20140930 OTC MONOGRAPH FINAL part331 Cardinal Health CALCIUM CARBONATE 1000 mg/1 49781-121_38aa7694-be88-4f92-97de-f152b1bf8b31 49781-121 HUMAN OTC DRUG Leader Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20140930 OTC MONOGRAPH FINAL part331 Cardinal Health CALCIUM CARBONATE 1000 mg/1 49781-126_368c3b57-04c7-4f97-b459-99e1d98661ea 49781-126 HUMAN OTC DRUG leader flu and severe cold and cough Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20141031 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 49781-127_50290ff5-42fe-44f5-9452-c23925783c78 49781-127 HUMAN OTC DRUG leader flu and severe cold and cough Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20141027 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 49781-128_a1d831bb-08f8-404e-8e46-ca03a6980c6b 49781-128 HUMAN OTC DRUG leader anti-diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20140925 ANDA ANDA075232 Cardinal Health LOPERAMIDE HYDROCHLORIDE 2 mg/1 49781-135_e2c09a4f-5f7f-43e9-9e32-cdbf0ce0c167 49781-135 HUMAN OTC DRUG leader allergy Diphenhydramine Hydrochloride TABLET ORAL 20141222 OTC MONOGRAPH FINAL part341 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49781-136_ac950742-8ee3-4c00-941f-14dc2233c571 49781-136 HUMAN OTC DRUG leader nasal Oxymetazoline HCl SPRAY NASAL 20141204 OTC MONOGRAPH FINAL part341 Cardinal Health OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 49781-137_cc75dc1f-2a63-496d-9515-e9119c73fd9d 49781-137 HUMAN OTC DRUG leader nasal oxymetazoline hydrochloride SPRAY NASAL 20141211 OTC MONOGRAPH FINAL part341 Cardinal Health OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 49789-010_3d2c1337-9f6c-4393-af4d-cf7ab619eb35 49789-010 HUMAN OTC DRUG ALLPANTO S ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE TABLET ORAL 20120301 OTC MONOGRAPH NOT FINAL part343 SAMSUNG PHARM IND. CO., LTD. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 162.5; 1; 7.5; 15 mg/448mg; mg/448mg; mg/448mg; mg/448mg 49789-020_fd396206-0f0c-4f70-9a15-743530a5c619 49789-020 HUMAN OTC DRUG COPANTO ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE TABLET ORAL 20120301 OTC MONOGRAPH NOT FINAL part343 SAMSUNG PHARM IND. CO., LTD. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 500; 3; 30 mg/670mg; mg/670mg; mg/670mg 49789-030_bac7bbc8-4121-4af5-a592-8f2b031eec71 49789-030 HUMAN OTC DRUG CAREPANTO DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE TABLET ORAL 20120301 OTC MONOGRAPH FINAL part341 SAMSUNG PHARM IND. CO., LTD. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 3; 15 mg/630mg; mg/630mg 49789-040_983e475f-3d03-4882-93b5-a545e895efe3 49789-040 HUMAN OTC DRUG PANTO A ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, GUAIFENESIN LIQUID ORAL 20120301 OTC MONOGRAPH NOT FINAL part343 SAMSUNG PHARM IND. CO., LTD. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; GUAIFENESIN 300; 2.5; 83.3 mg/30mL; mg/30mL; mg/30mL 49789-050_e9ad6a60-d765-4fa6-a155-b7e1e1bfc733 49789-050 HUMAN OTC DRUG PROBUFEN IBUPROFEN TABLET ORAL 20111201 OTC MONOGRAPH NOT FINAL part343 SAMSUNG PHARM IND. CO., LTD. IBUPROFEN 400 mg/537mg 49789-060_b1cce823-c1c1-4653-8047-fbc087977c58 49789-060 HUMAN OTC DRUG HIS ULC MINT BLUE Calcium carbonate TABLET, CHEWABLE ORAL 20121201 OTC MONOGRAPH FINAL part331 SAMSUNG PHARM IND. CO., LTD. CALCIUM CARBONATE 350 mg/492mg 49789-070_53f29a18-7cc0-49ea-bd40-c417fbaedfba 49789-070 HUMAN OTC DRUG Panto Flu DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE POWDER ORAL 20121201 OTC MONOGRAPH FINAL part341 SAMSUNG PHARM IND. CO., LTD. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 2.5; 15 mg/16999mg; mg/16999mg 49789-080_f2ff2cd2-0d60-4a66-adb6-c28d7c4f04e6 49789-080 HUMAN OTC DRUG BISMOL BISMUTH SUBSALICYLATE TABLET ORAL 20130201 OTC MONOGRAPH FINAL part335 SAMSUNG PHARM IND. CO., LTD. BISMUTH SUBSALICYLATE 262 mg/434mg 49790-001_74d8d839-3cf1-4fbf-bc2b-4999f577c7f4 49790-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091104 UNAPPROVED MEDICAL GAS Allen's Cylinder Testing & Inspection Company OXYGEN 992 mL/L 49794-003_d39d1621-4d46-4c22-a0ad-dd78fc4313ef 49794-003 HUMAN OTC DRUG Ear Wax Removal Aid Carbamide Peroxide LIQUID AURICULAR (OTIC) 20100827 OTC MONOGRAPH FINAL part344 Continental Manufacturing Chemist, Inc. CARBAMIDE PEROXIDE 6.5 mg/100mL 49794-009_ced19de1-ff9a-4d6b-868c-45164e65e05c 49794-009 HUMAN OTC DRUG Antibacterial Alcohol GEL TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333A Continental Manufacturing Chemist, Inc. ALCOHOL 620 g/kg 49794-010_6ee89d0f-fb5a-4229-bc4c-eb85c28966ad 49794-010 HUMAN OTC DRUG Antibacterial Ethyl Alcohol LIQUID TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333A Continental Manufacturing Chemist, Inc. ALCOHOL 620 g/L 49794-048_3110ce92-5a57-4dd5-84a0-aebaa5f0678a 49794-048 HUMAN OTC DRUG SPF-15 Sunscreen Octocrylene, Avobenzone LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Continental Manufacturing Chemist, Inc. AVOBENZONE; OCTOCRYLENE 30; 100 g/L; g/L 49795-227_8a7de862-5193-4363-aeab-e87ec4a13e68 49795-227 HUMAN OTC DRUG Pro-Flex Camphor, Menthol CREAM TOPICAL 20040201 OTC MONOGRAPH NOT FINAL part348 Nutri-Dyn Products Ltd. dba Professional Health Products CAMPHOR (NATURAL); MENTHOL 4; 4 g/100g; g/100g 49795-416_2ca61eb1-40d1-4811-80d1-bc102ccc2208 49795-416 HUMAN OTC DRUG Professional Therapy Muscle Care Pain Relieving Gel by Dr. Chris Oswald Maximum Strength Menthol, Camphor GEL TOPICAL 20100115 OTC MONOGRAPH NOT FINAL part348 Nutri-Dyn Products Ltd. dba Professional Health Products CAMPHOR; MENTHOL 4; 10 g/100g; g/100g 49795-417_a0ab277f-141c-4718-9f79-92775d1a61c2 49795-417 HUMAN OTC DRUG Professional Therapy Muscle Care Pain Relieving Ointment by Dr. Chris Oswald Maximum Strength Camphor, Menthol CREAM TOPICAL 20100115 OTC MONOGRAPH NOT FINAL part348 Nutri-Dyn Products Ltd. dba Professional Health Products CAMPHOR; MENTHOL 4; 4 g/100g; g/100g 49795-809_13ebda7d-fe67-4c51-a2c9-98669867d711 49795-809 HUMAN OTC DRUG Motion Medicine Camphor, Menthol CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part348 Nutri-Dyn Products Ltd. dba Professional Health Products CAMPHOR (NATURAL); MENTHOL 4; 4 g/100g; g/100g 49798-001_e12ff15e-4b70-4712-9d63-8c891640a64c 49798-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19560101 UNAPPROVED MEDICAL GAS James Oxygen and Supply Company OXYGEN 992 mL/L 49799-0001_df0bc9c2-3c87-4fcc-9f2a-51a98ce9c4da 49799-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091001 UNAPPROVED MEDICAL GAS Comfort Medical OXYGEN 99 L/100L 49799-001_819a51e5-bd40-4f7e-ab91-61c69d789986 49799-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091001 UNAPPROVED MEDICAL GAS Medical Equipment and Supplies of America, LLC OXYGEN 99 L/100L 49804-101_5e3e64e8-adb5-4072-a226-732d7ca75f57 49804-101 HUMAN OTC DRUG hybrid CF APAP 500 mg Phenylephrine HCL 5 mg Chlorpheniramine maleate 2 mg TABLET, FILM COATED ORAL 20100203 OTC MONOGRAPH FINAL part341 Hybrid-Rx LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 500; 2; 5 mg/1; mg/1; mg/1 49808-154_1d4cd32c-f033-47d4-bffc-ac694b011d09 49808-154 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide and Sulfur SULFACETAMIDE SODIUM AEROSOL, FOAM TOPICAL 20100225 UNAPPROVED DRUG OTHER Metacon Labs SULFACETAMIDE SODIUM; SULFUR 10; 5 g/100g; g/100g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 49808-384_34356957-f8a3-4c34-81ce-b5ea450561be 49808-384 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate Cream (lipid) 0.1% HYDROCORTISONE BUTYRATE CREAM TOPICAL 20130822 NDA AUTHORIZED GENERIC NDA020769 Metacon Labs HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49811-001_185c655b-7233-4398-948d-f47cd0b18a3d 49811-001 HUMAN OTC DRUG Amari Silicea, Zincum Oxidatum CREAM TOPICAL 20080831 UNAPPROVED HOMEOPATHIC Pacific Media Direct, LLC SILICON DIOXIDE; ZINC OXIDE .85; .085 g/4.25g; g/4.25g 49817-0046_98cbca25-5d54-4969-8ae6-c7eb5d0b1adc 49817-0046 HUMAN OTC DRUG PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 01 BEIGE PALE OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20120726 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 49817-0047_7a43da25-9260-456d-83ac-439f2c55287c 49817-0047 HUMAN OTC DRUG PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 02 BEIGE CLAIR OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 49817-0048_7d823bce-f014-4f7d-8530-1fd840ba938a 49817-0048 HUMAN OTC DRUG PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 03 BEIGE NATUREL OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 49817-0049_9beb566e-471b-4b14-873b-df33f18e6dc2 49817-0049 HUMAN OTC DRUG PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 04 BEIGE MOYEN OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 49817-0050_c6a3558d-adc1-4d34-a31d-0454456df547 49817-0050 HUMAN OTC DRUG PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 05 BEIGE FONCE OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 49817-0051_9ae75b68-dff2-4341-a8e6-7677add62566 49817-0051 HUMAN OTC DRUG PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 12 ROSE CLAIR OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 49817-0052_41e28721-5dba-4731-8d34-2d984c993a76 49817-0052 HUMAN OTC DRUG PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 13 ROSE NATUREL OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 49817-0053_84f26f32-1846-4b98-b63d-c4469a693ac7 49817-0053 HUMAN OTC DRUG PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 23 DORE NATUREL OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 49817-0054_7c3cd7ea-3382-4933-9aeb-5344e51ff1fd 49817-0054 HUMAN OTC DRUG PARURE DE LUMIERE LIGHT-DIFFUSING FOUNDATION WITH SUNSCREEN MOISTURE INFUSION BROAD SPECTRUM SPF 25 31 AMBRE PALE OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 49817-0055_a4c316b4-cc0d-444d-bddd-70e532da14a0 49817-0055 HUMAN OTC DRUG LINGERIE DE PEAU INVISIBLE SKIN-FUSION FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 01 BEIGE PALE OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain S.A OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 49817-0056_6b0552f6-1012-458f-8692-2c57352e2d82 49817-0056 HUMAN OTC DRUG LINGERIE DE PEAU INVISIBLE SKIN-FUSION FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 02 BEIGE CLAIR OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain S.A OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 49817-0057_15e2b501-ac46-4c7b-a11b-7b88c12ac9bf 49817-0057 HUMAN OTC DRUG LINGERIE DE PEAU INVISIBLE SKIN-FUSION FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 03 BEIGE NATUREL OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain S.A OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 49817-0058_841da84b-e6a7-43f6-a635-4045314542c2 49817-0058 HUMAN OTC DRUG LINGERIE DE PEAU INVISIBLE SKIN-FUSION FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 04 BEIGE MOYEN OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain S.A OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 49817-0059_31eddedf-8472-4e99-82e0-fec1411aec25 49817-0059 HUMAN OTC DRUG LINGERIE DE PEAU INVISIBLE SKIN-FUSION FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 05 BEIGE FONCE OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain S.A OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 49817-0060_1ef70406-2800-4a18-a7a7-ebfa352c923f 49817-0060 HUMAN OTC DRUG LINGERIE DE PEAU INVISIBLE SKIN-FUSION FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 12 ROSE CLAIR OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain S.A OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 49817-0061_a310cd1d-d45a-4f0b-9c32-03cf88b8d34a 49817-0061 HUMAN OTC DRUG LINGERIE DE PEAU INVISIBLE SKIN-FUSION FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 13 ROSE NATUREL OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain S.A OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 49817-0062_87636e78-100a-4ddf-8619-5a558f62950c 49817-0062 HUMAN OTC DRUG LINGERIE DE PEAU INVISIBLE SKIN-FUSION FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 31 AMBRE PALE OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain S.A OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 49817-0063_2a32a0dc-d4f4-4ae4-b472-d2222a7332a6 49817-0063 HUMAN OTC DRUG TERRACOTTA BRONZING MIST WITH SUNSCREEN SPF 10 LIGHT 01 OCTINOXATE POWDER TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain S.A. OCTINOXATE 25 mg/mL 49817-0064_38b8da5a-d097-496b-a695-ee88d2b0b328 49817-0064 HUMAN OTC DRUG TERRACOTTA BRONZING MIST WITH SUNSCREEN SPF 10 02 MEDIUM OCTINOXATE POWDER TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain S.A. OCTINOXATE 25 mg/mL 49817-0065_447f83e6-95ea-414d-b1de-a11b928bfa57 49817-0065 HUMAN OTC DRUG Lingerie De Peau BB Beauty Booster Invisible Skin-Fusion Multi-Perfecting Makeup With Sunscreen Broad Spectrum SPF 30 LIGHT OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 37.4; 10; 35.5 mg/mL; mg/mL; mg/mL 49817-0066_c81f738d-a4df-4363-8123-6481c7f03fb0 49817-0066 HUMAN OTC DRUG Lingerie De Peau BB Beauty Booster Invisible Skin-Fusion Multi-Perfecting Makeup With Sunscreen Broad Spectrum SPF 30 MEDIUM OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 37.4; 10; 35.5 mg/mL; mg/mL; mg/mL 49817-0067_2c5c3e7a-8270-4c41-8e12-0208c213d59c 49817-0067 HUMAN OTC DRUG TENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 01 BEIGE PALE TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. TITANIUM DIOXIDE 29.2 mg/mL 49817-0068_ee510cee-9ede-4c28-ab0d-4a1d2e9231e4 49817-0068 HUMAN OTC DRUG TENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 02 BEIGE CLAIR TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. TITANIUM DIOXIDE 29.2 mg/mL 49817-0069_22669012-671d-48ca-9d42-81d96c2ca170 49817-0069 HUMAN OTC DRUG TENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 03 BEIGE NATUREL TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. TITANIUM DIOXIDE 29.2 mg/mL 49817-0070_944f05b1-756d-4f49-9849-cfdeaf5da092 49817-0070 HUMAN OTC DRUG TENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 04 BEIGE MOYEN TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. TITANIUM DIOXIDE 29.2 mg/mL 49817-0071_1b7c33c6-521a-45fb-a9d1-5b40c77d0a90 49817-0071 HUMAN OTC DRUG TENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 12 ROSE CLAIR TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. TITANIUM DIOXIDE 29.2 mg/mL 49817-0072_9cfc616b-8113-40a1-b704-55e9f0ccb141 49817-0072 HUMAN OTC DRUG TENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 13 ROSE NATUREL TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. TITANIUM DIOXIDE 29.2 mg/mL 49817-0073_a49ac895-3e00-4e48-9b27-f8afcca04945 49817-0073 HUMAN OTC DRUG TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 EBONY OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 39.9; 43.8 mg/mL; mg/mL 49817-0074_dff7a5f5-8848-4803-a1a5-fafca0f46f24 49817-0074 HUMAN OTC DRUG TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 DARK OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 39.9; 43.8 mg/mL; mg/mL 49817-0075_96c032ed-6fe2-4324-ab60-2a3caac9b211 49817-0075 HUMAN OTC DRUG TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 MEDIUM OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 39.9; 43.8 mg/mL; mg/mL 49817-0076_7e97b0dd-2845-474b-bc00-57458e7ff13b 49817-0076 HUMAN OTC DRUG TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 NATURAL OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 39.9; 43.8 mg/mL; mg/mL 49817-0077_7d63b901-8c59-49c9-a903-d66e82da046d 49817-0077 HUMAN OTC DRUG TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 LIGHT OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 39.9; 43.8 mg/mL; mg/mL 49817-0078_1d41b6cd-0106-4c0e-8d13-8256ee0645b6 49817-0078 HUMAN OTC DRUG SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 LIGHT OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 74.9; 38.4 mg/mL; mg/mL 49817-0079_b0da48e0-a758-44dd-993c-31056ee9ccb0 49817-0079 HUMAN OTC DRUG SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 74.9; 38.4 mg/mL; mg/mL 49817-0080_9ce812d7-823d-4872-beef-c94f0f036581 49817-0080 HUMAN OTC DRUG LINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 LIGHT OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 37.4; 10; 35.5 mg/mL; mg/mL; mg/mL 49817-0081_30271a52-32eb-43f0-8356-ba8ab2446b3c 49817-0081 HUMAN OTC DRUG LINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 MEDIUM OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 37.4; 10; 35.5 mg/mL; mg/mL; mg/mL 49817-0082_6e1bc893-adc5-4032-b6eb-add0742c1b2c 49817-0082 HUMAN OTC DRUG LINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 NATURAL OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 37.4; 10; 35.5 mg/mL; mg/mL; mg/mL 49817-0083_74139215-4e24-459f-944c-c4ec1047ed8a 49817-0083 HUMAN OTC DRUG GUERLAIN METEORITES BABY GLOW BROAD SPECTRUM SPF 25 2 LIGHT OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20141020 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 54.9; 21.9 mg/mL; mg/mL 49817-0084_2e6622a5-ae1c-4bf9-9392-288ad4796d9a 49817-0084 HUMAN OTC DRUG GUERLAIN METEORITES BABY GLOW BROAD SPECTRUM SPF 25 3 MEDIUM OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20141020 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 54.9; 21.9 mg/mL; mg/mL 49817-0085_bd3305d4-e855-49d2-b15b-ba9aea3f59ba 49817-0085 HUMAN OTC DRUG GUERLAIN METEORITES BABY GLOW BROAD SPECTRUM SPF 25 4 GOLDEN OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20141020 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; TITANIUM DIOXIDE 54.9; 21.9 mg/mL; mg/mL 49817-0089_735637b2-50da-4fa1-b696-08fd4bd638db 49817-0089 HUMAN OTC DRUG ORCHIDEE IMPERIALE - EXCEPTIONAL COMPLETE CARE - THE UV BEAUTY PROTECTOR WITH SUNSCREEN BROAD SPECTRUM SPF 50 UNIVERSAL SHADE OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part352 Guerlain S.A. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 74.9; 20; 67.4 mg/mL; mg/mL; mg/mL 49817-1984_2a191fde-6269-4ad0-8843-674dff7ead24 49817-1984 HUMAN OTC DRUG Fresh Sugar Kisses Sugar Rose Tinted Lip Treatment SPF 15 and Sugar PlumTinted Lip Treatment SPF 15 octinoxate and oxybenzone KIT 20100601 OTC MONOGRAPH NOT FINAL part352 Guerlain 49817-1985_b28c21cd-6952-4a34-8a07-f08760cfae90 49817-1985 HUMAN OTC DRUG Fresh Sugar Kisses Sugar Lip Treatment SPF 15 and Sugar Rose Tinted Lip Treatment SPF 15 octinoxate and oxybenzone KIT 20090601 OTC MONOGRAPH NOT FINAL part352 Guerlain 49817-1986_8d142844-baf4-40b8-8dee-279f865391ff 49817-1986 HUMAN OTC DRUG Fresh Sugar Roll-On Deodorant Antiperspirant aluminum chlorohydrate LIQUID TOPICAL 20020501 OTC MONOGRAPH FINAL part350 Guerlain ALUMINUM CHLOROHYDRATE 15 g/100g 49817-1987_53cabb11-252a-44dd-b7dd-974e004e23aa 49817-1987 HUMAN OTC DRUG Fresh Sugar Honey Tinted Lip Treatment SPF15 octinoxate and oxybenzone LIPSTICK TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; OXYBENZONE 7.49; 2 g/100g; g/100g 49817-1988_850cf12e-7152-4bfc-82fa-d882cd7d5ad2 49817-1988 HUMAN OTC DRUG Fresh Sugar Rose Tinted Lip Treatment SPF 15 octinoxate and oxybenzone LIPSTICK TOPICAL 20090601 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; OXYBENZONE 7.49; 2 g/100g; g/100g 49817-1989_8ed54a06-b651-42cc-8e30-f287b2c9831a 49817-1989 HUMAN OTC DRUG Fresh Sugar Plum Tinted Lip Treatment SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; OXYBENZONE 7.49; 2 g/100g; g/100g 49817-1990_a858d752-bfb6-4d52-a4ba-6744576f15c0 49817-1990 HUMAN OTC DRUG Fresh Sugar Lip Treatment SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20030601 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; OXYBENZONE 7.49; 2 g/100g; g/100g 49817-1991_fbd82275-064d-4e93-a8fe-f82025023fcb 49817-1991 HUMAN OTC DRUG Fresh Umbrian Clay Freshface Foundation SPF 20 Sun Empress Octinoxate EMULSION TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE 3 g/100g 49817-1992_302a7de4-0111-426c-bf24-5e78603c117a 49817-1992 HUMAN OTC DRUG Fresh Umbrian Clay Freshface Foundation SPF 20 Marrakech Octinoxate EMULSION TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE 3 g/100g 49817-1993_4e5d3468-57ca-4e71-91b4-3c381fb620b9 49817-1993 HUMAN OTC DRUG Fresh Umbrian Clay Freshface Foundation SPF 20 Rio Samba Octinoxate EMULSION TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE 3 g/100g 49817-1994_e4e86d2e-7f66-4b51-a259-6b73c852c00d 49817-1994 HUMAN OTC DRUG Fresh Umbrian Clay Freshface Foundation SPF 20 Sandy Lane Octinoxate EMULSION TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE 3 g/100g 49817-1995_80d7c6e1-8280-4f1c-82b0-e7ac1021b53a 49817-1995 HUMAN PRESCRIPTION DRUG Fresh Umbrain Clay Freshface Foundation SPF 20 Croisette Octinoxate EMULSION TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE 3 g/100g 49817-1996_084a0b5f-cfc9-414d-8468-6c9cfd0d360c 49817-1996 HUMAN OTC DRUG Fresh Umbrian Clay Freshface Foundation SPF 20 Chalet Girl Octinoxate EMULSION TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE 3 g/100g 49817-1997_1cca8e68-daf1-41ca-8d80-53e07793cd43 49817-1997 HUMAN OTC DRUG Fresh Umbrian Clay Freshface Foundation SPF 20 Seventh Veil Octinoxate EMULSION TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE 3 g/100g 49817-1998_f7a6aed2-db2d-49b4-9db7-84cd2d2f11d3 49817-1998 HUMAN OTC DRUG Fresh Umbrian Clay Freshface Foundation SPF 20 Cloudy Bay Octinoxate EMULSION TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE 3 g/100g 49817-1999_37adecbc-4d3a-46c1-96bc-5c2e256f521d 49817-1999 HUMAN OTC DRUG Fresh Umbrian Clay Freshface Foundation SPF 20 Fair Isle Octinoxate EMULSION TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE 3 g/100g 49825-070_cc43dbee-189a-4fa7-a813-e9755a826439 49825-070 HUMAN OTC DRUG FORME COSMETICS DELICIOUS LIP BALM SPF 12 TITANIUM DIOXIDE, OCTINOXATE, AVOBENZONE LIPSTICK TOPICAL 20091022 OTC MONOGRAPH NOT FINAL part352 CHROMAVIS SPA AVOBENZONE; OCTINOXATE; TITANIUM DIOXIDE .048; .192; .04128 g/3.2g; g/3.2g; g/3.2g 49825-111_f9832814-3ee2-457b-aee8-b6fd421b16c4 49825-111 HUMAN PRESCRIPTION DRUG Bioelements Active Astringent Salicylic Acid LIQUID TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Bioelements SALICYLIC ACID .5 mL/100mL 49825-112_b2b61a68-fe3e-4569-9da5-388e3cd97779 49825-112 HUMAN OTC DRUG Bioelements Amino Mask Salicylic Acid CREAM TOPICAL 20090101 OTC MONOGRAPH FINAL part358H Bioelements SALICYLIC ACID 2 mL/100mL 49825-113_87645f39-f53a-463a-b956-e4172f3ecdb2 49825-113 HUMAN OTC DRUG Bioelements Spotless Cleanser Salicylic Acid GEL TOPICAL 20100505 OTC MONOGRAPH FINAL part358H Bioelements Inc. SALICYLIC ACID 2 mL/100mL 49825-114_19d7afa4-cd7c-4876-91f7-cf916fa73748 49825-114 HUMAN OTC DRUG Bioelements Sun Diffusing Protector SPF 15 Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Bioelements Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 3; .01; .01 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 49825-115_b33173fb-9de4-4d5c-8b87-5d4dc21b218c 49825-115 HUMAN OTC DRUG Bioelements FaceScreen Homosalate, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Bioelements, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 10; 7.5; 5; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL 49825-116_9396b4e0-a337-48a4-b530-c8785c96c772 49825-116 HUMAN OTC DRUG Bioelements Breakout Control Benzoyl Peroxide CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333D Bioelements, Inc. BENZOYL PEROXIDE 2.5 mL/100mL 49825-117_059a477f-0046-4d61-8b56-59ffd0c287cd 49825-117 HUMAN OTC DRUG Bioelements, Inc. SPF 50 FaceScreen Homosalate, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 Bioelements, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 10; 7.5; 5; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL 49825-119_da5d25e6-bce7-4c25-a91a-b83a3e6b54a5 49825-119 HUMAN OTC DRUG Bioelements Immediate Comfort Hydrocortisone Hydrocortisone LOTION TOPICAL 20100819 OTC MONOGRAPH NOT FINAL part348 Bioelements, Inc. HYDROCORTISONE 1 mL/100mL 49825-120_15cecf0f-cbff-4973-a415-a7ac73605db5 49825-120 HUMAN OTC DRUG Sun Diffusing Protector SPF 15 Avobenzone, Homosalate, Octocrylene, Octyl Salicylate, Oxybenzone LOTION TOPICAL 20120321 OTC MONOGRAPH FINAL part352 Bioelements Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 7.5; 5; 1.8; .49 mL/100mL; mL/100mL; mm/100mL; mL/100mL; mL/100mL 49825-121_dfc63c1a-873f-4e93-b46e-7ed7d6311773 49825-121 HUMAN OTC DRUG Ray Defense SPF 30 Sunscreen Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone LIQUID TOPICAL 20120323 OTC MONOGRAPH NOT FINAL part352 Bioelements, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 7.5; 5; 7.5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 49825-122_b735fb3d-6a7a-412d-a9c4-2577c6bc9470 49825-122 HUMAN OTC DRUG Facescreen SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene,Oxybenzone LIQUID TOPICAL 20120323 OTC MONOGRAPH NOT FINAL part352 Bioelements AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 7; 5; 5; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 49825-123_e77fa75f-9d7f-4749-81e0-9089b3811174 49825-123 HUMAN OTC DRUG Bioelements Amino Mask Sulfur CREAM TOPICAL 20120426 OTC MONOGRAPH FINAL part333D Bioelements SULFUR 5 mL/100mL 49825-124_c1266138-fbc3-4663-a73d-6d941851823b 49825-124 HUMAN OTC DRUG Breakout Control Acne Treatment Benzoyl Peroxide LOTION TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part333D Bioelements, Inc. BENZOYL PEROXIDE 5 mL/100mL 49825-125_2070706a-6f74-4235-be56-2143d737b653 49825-125 HUMAN OTC DRUG Pore Rescue Acne Salicylic Acid GEL TOPICAL 20120502 OTC MONOGRAPH FINAL part358H Bioelements SALICYLIC ACID 1 mL/100mL 49825-126_0afc9d3f-47f9-4424-8ad4-2b4b7d34607f 49825-126 HUMAN PRESCRIPTION DRUG Bioelements Immediate Comfort Hydrocortisone Acetate LOTION TOPICAL 20120823 OTC MONOGRAPH NOT FINAL part348 Bioelements, Inc. HYDROCORTISONE ACETATE .088 mL/88mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49825-127_a5ee9f82-fcf6-42c3-95c7-6f14fcb5c231 49825-127 HUMAN OTC DRUG Pore Rescue Acne Biolements Salicylic Acid GEL TOPICAL 20130613 OTC MONOGRAPH FINAL part358H Bioelements SALICYLIC ACID 1 g/100mL 49825-128_08c8491e-329f-4653-9e2f-df1aed67e1c8 49825-128 HUMAN OTC DRUG Amino Mask Bioelements Sulfur CREAM TOPICAL 20130614 OTC MONOGRAPH FINAL part358H Bioelements SULFUR 5 g/100mL 49825-129_6428d539-3f23-46a5-9887-55c56c8d1f83 49825-129 HUMAN OTC DRUG Breakout Control Bioelements Benzoyl Peroxide CREAM TOPICAL 20130614 OTC MONOGRAPH FINAL part333D Bioelements, Inc. BENZOYL PEROXIDE 5 g/100mL 49825-130_e1a609b0-d5e6-40e9-9021-efa39188bb5b 49825-130 HUMAN OTC DRUG Acne Toner Biolements Salicylic Acid CREAM TOPICAL 20130617 OTC MONOGRAPH FINAL part333D Bioelements, Inc. SALICYLIC ACID .5 g/100mL 49825-131_d72fb442-0e78-4b2b-9ffe-05d7fbd4e793 49825-131 HUMAN OTC DRUG Spotless Cleanser Bioelements Salicylic Acid CREAM TOPICAL 20130617 OTC MONOGRAPH FINAL part333D Bioelements, Inc. SALICYLIC ACID 2 g/100mL 49825-132_5054ad1c-9909-485b-a078-0bde8f0e3981 49825-132 HUMAN OTC DRUG Ray Defense Borad Spectrum SPF 30 sunscreen Biolements Avobenzone , Octinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20130711 OTC MONOGRAPH NOT FINAL part352 Bioelements, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 7.5; 5; 7; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 49825-133_d369b009-5027-458e-b534-841101f8ad5e 49825-133 HUMAN OTC DRUG Broad Spectrum SPF 50 Sunscreen Bioelements Avobenzone, Homosalate, Ocinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20130711 OTC MONOGRAPH NOT FINAL part352 Bioelements AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 7; 5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 49825-134_2619f69c-4a0d-4ebd-b922-0c31339c8457 49825-134 HUMAN OTC DRUG Immediate Comfort Bioelements Hydrocortisone Acetate LOTION TOPICAL 20120823 OTC MONOGRAPH NOT FINAL part348 Bioelements, Inc. HYDROCORTISONE ACETATE 1 g/88mL 49825-327_a2a04d3a-3927-4fd9-b532-ac77eb22fe40 49825-327 HUMAN OTC DRUG Anti-Clog Concentrate Bioelements, Inc. Salicylic Acid CREAM TOPICAL 20100909 OTC MONOGRAPH FINAL part358H Bioelements SALICYLIC ACID 5 mL/100mL 49825-694_9406b859-0859-4c70-aa50-3926b595b43d 49825-694 HUMAN OTC DRUG Power Base Bioelements, Inc. Salicylic Acid CREAM TOPICAL 20100909 OTC MONOGRAPH FINAL part358H Bioelements, Inc. SALICYLIC ACID 29 mL/100mL 49825-724_2b35cf2d-7486-4c81-82b7-4346e588f3cb 49825-724 HUMAN OTC DRUG Anti-Bac Concentrate Bioelements, Inc. Sulfur CREAM TOPICAL 20100909 OTC MONOGRAPH FINAL part358H Bioelements, Inc. SULFUR 5 mL/100mL 49834-001_885df0e0-63d4-11e1-a41e-0002a5d5c51b 49834-001 HUMAN OTC DRUG Gellert Joint Care Capsaicin CREAM TOPICAL 20090501 OTC MONOGRAPH NOT FINAL part348 Gellert Health Solutions LLC CAPSAICIN .17 g/100g 49839-100_434e0805-2e13-4bd4-8764-6c7da5a2c890 49839-100 HUMAN OTC DRUG BACTEX Antiseptic Hand Sanitizer ALCOHOL GEL TOPICAL 20091101 OTC MONOGRAPH FINAL part333 Punto Rojo, S.A ALCOHOL 62 mL/100mL 49839-200_8768191f-d306-4348-b7f1-e878c8c3ead0 49839-200 HUMAN OTC DRUG BACTEX Antiseptic Hand Sanitizer ALCOHOL GEL TOPICAL 20091101 OTC MONOGRAPH FINAL part333 Punto Rojo, S.A ALCOHOL 62 mL/100mL 49839-300_447cba3b-bfdf-4193-9e67-d406a35835ec 49839-300 HUMAN OTC DRUG BACTEX Antiseptic Hand Sanitizer ALCOHOL GEL TOPICAL 20091101 OTC MONOGRAPH FINAL part333 Punto Rojo, S.A ALCOHOL 62 mL/100mL 49852-001_c7a26701-cc9a-4065-b961-d4a9f7ceb949 49852-001 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20100107 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 65 mL/100mL 49852-002_7429805f-2ccf-4940-884d-bd11dd632241 49852-002 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL 49852-003_9b976d12-431c-4b3b-aaf0-475859bae24d 49852-003 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 65 mL/100mL 49852-004_49cc533f-5b9b-450e-b7ce-6ac0b9c63064 49852-004 HUMAN OTC DRUG moisturizing anti-bacterial hand soap TRICLOSAN LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL 49852-005_6f3355c9-da00-43be-8ff1-595aaa147407 49852-005 HUMAN OTC DRUG anti-bacterial foaming TRICLOSAN SOAP TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL 49852-006_8543b3b9-cf4c-4fed-9ae2-d9e3f6b2a16f 49852-006 HUMAN OTC DRUG moisturizing anti-bacterial hand soap TRICLOSAN LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL 49852-007_7aa82e96-6731-4897-b193-767d1908018a 49852-007 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL 49852-009_ac9d7c4c-c4f9-4ac7-a9e9-df3a56c9e36c 49852-009 HUMAN OTC DRUG moisturizing anti-bacterial hand soap TRICLOSAN LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL 49852-011_64233e92-5712-4d34-9092-b1ae4ef331f0 49852-011 HUMAN OTC DRUG anti-bacterial foaming TRICLOSAN SOAP TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL 49852-012_a2650678-96bf-4b01-ab96-c6dd4be8fb9f 49852-012 HUMAN OTC DRUG anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333E Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL 49852-013_2e5bfee7-c831-4ae1-9ce8-070b950ca9a9 49852-013 HUMAN OTC DRUG anti-bacterial foaming TRICLOSAN SOAP TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL 49852-014_db1ededd-fe07-4e94-bfed-0a0e92924bd1 49852-014 HUMAN OTC DRUG moisturizing anti-bacterial hand soap TRICLOSAN LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL 49852-015_91c7dcb7-fa0e-426b-9872-ed5b2375b2d7 49852-015 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL 49852-016_bcfcf47e-e76a-4e98-8820-675839f5c4ad 49852-016 HUMAN OTC DRUG anti-bacterial foaming TRICLOSAN SOAP TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL 49852-017_08468bea-d3a0-4652-92d3-0b6243c03517 49852-017 HUMAN OTC DRUG anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333E Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL 49852-025_651b6633-67d3-4b67-8597-9697f8b46d0b 49852-025 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL 49852-030_231f30b1-303f-4a81-9d29-def719081a38 49852-030 HUMAN OTC DRUG waterless anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 63 mL/100mL 49852-031_d5e31d2d-e313-42b5-a5d8-2847f33d5f82 49852-031 HUMAN OTC DRUG waterless anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 63 mL/100mL 49852-032_5bea66de-2f5f-4d59-93fd-0dacfd727e94 49852-032 HUMAN OTC DRUG waterless anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 63 mL/100mL 49852-033_8128c495-e0cf-40bd-b0b1-b70e04fc752e 49852-033 HUMAN OTC DRUG waterless anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 63 mL/100mL 49852-034_ffd4f2fb-6eb9-432e-8eba-435800bcd131 49852-034 HUMAN OTC DRUG waterless anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 63 mL/100mL 49852-069_0ce6c9e2-bd8f-4d97-916b-19972ea5f383 49852-069 HUMAN OTC DRUG anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333E Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL 49852-160_589503f4-50c9-4b36-8962-24600cf5e53e 49852-160 HUMAN OTC DRUG anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333E Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL 49852-161_4f2d07b2-357b-43a0-93e5-65d572306112 49852-161 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20091211 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL 49852-162_2d039dd6-6bb3-47be-9bf1-7c5fe93aa52c 49852-162 HUMAN OTC DRUG moisturizing anti-bacterial hand soap TRICLOSAN LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL 49852-163_5f2de8ed-41ac-49ee-a468-d76081fa9897 49852-163 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL 49852-164_c5a42019-22ec-40c3-b2af-b4b63bbf9f1c 49852-164 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL 49852-165_7c2e405f-6c9d-4816-b8e2-b9eab149c0ad 49852-165 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL 49852-166_328ecc4e-767e-4272-bda1-498e5e40fba9 49852-166 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part333E Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL 49852-169_3c185938-b1ad-4ea3-b918-55361c93d992 49852-169 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20091211 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL 49852-170_492a78af-6ee7-40d8-8d59-1003ac073397 49852-170 HUMAN OTC DRUG moisturizing anti-bacterial hand soap TRICLOSAN LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL 49852-171_f26c0e48-35a9-4531-afd5-126befde1dff 49852-171 HUMAN OTC DRUG simple pleasures antibacterial foaming hand TRICLOSAN SOAP TOPICAL 20121021 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .3 g/100mL 49852-172_9c04c602-a1ca-4039-a187-c7914add7948 49852-172 HUMAN OTC DRUG simple pleasures antibacterial foaming hand TRICLOSAN SOAP TOPICAL 20121021 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .3 g/100mL 49852-173_d217f066-4ad6-4ba0-884d-b9549f782da4 49852-173 HUMAN OTC DRUG simple pleasures antibacterial foaming hand TRICLOSAN SOAP TOPICAL 20121021 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .3 g/100mL 49852-174_6d5f4441-6153-486a-bb8e-aa8d8c61a8ea 49852-174 HUMAN OTC DRUG simple pleasures antibacterial hand TRICLOSAN SOAP TOPICAL 20121021 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .3 g/100mL 49852-175_fb27bfbc-db30-4d3c-be2c-81ba22bfe41f 49852-175 HUMAN OTC DRUG simple pleasures antibacterial foaming hand TRICLOSAN SOAP TOPICAL 20121021 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .3 g/100mL 49852-176_79f963e9-4e4a-4bd5-878e-137ac7af66f1 49852-176 HUMAN OTC DRUG simple pleasures antibacterial foaming hand TRICLOSAN SOAP TOPICAL 20121021 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .3 g/100mL 49852-180_5b683090-237e-42c4-b896-a8deb84c1a59 49852-180 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Alcohol LIQUID TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL 49852-181_3fcf0266-213e-434e-9e3a-a05203363331 49852-181 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Alcohol LIQUID TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL 49852-182_213951ec-9e15-4068-8ee7-249156263a44 49852-182 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Alcohol LIQUID TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL 49852-183_7eb205ad-358b-43a2-9386-ab2b89cce6e6 49852-183 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Alcohol LIQUID TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL 49852-184_2125cce3-df11-4702-8c36-9de57a201667 49852-184 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Alcohol LIQUID TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL 49852-200_22f42874-2f04-45b9-9199-9b9e025974d1 49852-200 HUMAN OTC DRUG Suntan Lotion OCTINOXATE OXYBENZONE TITANIUM DIOXIDE LOTION TOPICAL 20100228 OTC MONOGRAPH FINAL part352 Tri-Coastal Design Company Inc. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7; 6; 1 mL/100mL; mL/100mL; mL/100mL 49852-201_45b4245a-efad-4b1d-b924-fe5fdf36bbc6 49852-201 HUMAN OTC DRUG Suntan Lotion OCTINOXATE OXYBENZONE TITANIUM DIOXIDE LOTION TOPICAL 20100228 OTC MONOGRAPH FINAL part352 Tri-Coastal Design Company Inc. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7; 6; 1 mL/100mL; mL/100mL; mL/100mL 49852-202_f5b7726a-b83a-4df8-8642-d56ec01793c4 49852-202 HUMAN OTC DRUG Lip Balm OCTINOXATE OXYBENZONE DIMETHICONE LIPSTICK TOPICAL 20100228 OTC MONOGRAPH FINAL part352 Tri-Coastal Design Company Inc. DIMETHICONE; OCTINOXATE; OXYBENZONE 6; 6; 6 g/100g; g/100g; g/100g 49852-300_8b437ed2-ec52-4f5c-90ed-c103d127b46d 49852-300 HUMAN OTC DRUG anti-bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL 49852-301_32d26728-4a36-4399-b8e5-30f0ebb833ae 49852-301 HUMAN OTC DRUG anti-bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL 49852-302_cda34b84-4152-4dfb-8174-79d282c31dff 49852-302 HUMAN OTC DRUG anti-bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL 49852-303_7ac96c53-5c7d-4d15-85d9-f1e7fbad5dad 49852-303 HUMAN OTC DRUG anti-bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL 49854-001_0be88133-4808-4bb2-8859-9229ca7f30d5 49854-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19870101 UNAPPROVED MEDICAL GAS Seeley Enterprises Inc OXYGEN 999 mL/L 49869-002_a238b922-010a-40fb-8ee8-da3a82c376c4 49869-002 HUMAN OTC DRUG Avitears polysorbate 80 SOLUTION/ DROPS TOPICAL 20090717 OTC MONOGRAPH FINAL part349 Pinnacle Science, LLc POLYSORBATE 80 10 mg/mL 49873-018_e94904cf-d0b5-4a35-a1ba-11954b50223e 49873-018 HUMAN OTC DRUG Satohap dl-camphor, l-menthol, methyl salicylate PATCH TOPICAL 19891108 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 5; 4; 8 mg/1; mg/1; mg/1 49873-019_ededce60-9749-44c0-9b7c-31a0c8072bd0 49873-019 HUMAN OTC DRUG KEEPAN A benzalkonium chloride, lidocaine hydrochloride SPRAY TOPICAL 19810715 OTC MONOGRAPH NOT FINAL part333A Sato Pharmaceutical Co., Ltd. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .1; 1 g/100mL; g/100mL 49873-020_26735802-067b-4cf0-988a-ac6ee992a0e5 49873-020 HUMAN OTC DRUG Dorama-Neo water LIQUID OPHTHALMIC 19831108 OTC MONOGRAPH FINAL part349 Sato Pharmaceutical Co., Ltd. WATER 98.4 mL/100mL 49873-044_d6810599-b9b2-486b-bba1-a2a77ada3636 49873-044 HUMAN OTC DRUG Sato Clear NAPHAZOLINE HYDROCHLORIDE SOLUTION/ DROPS OPHTHALMIC 19890531 OTC MONOGRAPH FINAL part349 Sato Pharmaceutical Co., Ltd. NAPHAZOLINE HYDROCHLORIDE 12 mg/100mL 49873-045_55d0ad13-a37a-4366-b461-1d35195c1f93 49873-045 HUMAN OTC DRUG INON aluminum hydroxide, magnesium carbonate, sodium bicarbonate GRANULE ORAL 19890531 OTC MONOGRAPH FINAL part331 Sato Pharmaceutical Co., Ltd. ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE; SODIUM BICARBONATE 400; 400; 700 mg/1.92g; mg/1.92g; mg/1.92g 49873-050_7214f42c-c4c9-4aca-a3c1-507d376d2068 49873-050 HUMAN OTC DRUG Hi Vetic tolnaftate SOLUTION TOPICAL 19900814 OTC MONOGRAPH FINAL part333C Sato Pharmaceutical Co., Ltd. TOLNAFTATE 1 g/100mL 49873-056_7b7ea288-3a83-444e-9763-2c14f33e5997 49873-056 HUMAN OTC DRUG Hi Vetic tolnaftate OINTMENT TOPICAL 19961025 OTC MONOGRAPH FINAL part333C Sato Pharmaceutical Co., Ltd. TOLNAFTATE 1 g/100g 49873-057_7750c714-3e28-4951-a0ea-b8521d6ec2a0 49873-057 HUMAN OTC DRUG Nazal Naphazoline hydrochloride LIQUID NASAL 19900611 OTC MONOGRAPH NOT FINAL part341 Sato Pharmaceutical Co., Ltd. NAPHAZOLINE HYDROCHLORIDE 50 mg/100mL 49873-060_262d37c0-19a5-472b-a270-7f36cd8145cf 49873-060 HUMAN OTC DRUG Satogesic dl-camphor, l-menthol, methyl salicylate PATCH TOPICAL 19901203 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 5; 4; 8 mg/1; mg/1; mg/1 49873-065_b20010de-daf7-4aa7-8304-5ed83dc7a9c9 49873-065 HUMAN OTC DRUG Satohap methyl salicylate, dl-camphor, l-menthol LOTION TOPICAL 19910205 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 5; 4; 10 g/100mL; g/100mL; g/100mL 49873-067_1a6b231c-2752-4172-bdb4-4ef51fe2739d 49873-067 HUMAN OTC DRUG Satogesic dl-camphor, l-menthol, methyl salicylate SPRAY TOPICAL 19911125 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 5; 4; 10 g/100mL; g/100mL; g/100mL 49873-068_e1cbbc3f-da84-4b43-9caf-de6e04ddd5a1 49873-068 HUMAN OTC DRUG Satohap methyl salicylate, dl-camphor, l-menthol SPRAY TOPICAL 20061109 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 5; 4; 10 g/100mL; g/100mL; g/100mL 49873-078_e89ccd89-1018-4b67-9d64-e54dab6ddf40 49873-078 HUMAN OTC DRUG Satos Corn and Callus Remover salicylic acid LIQUID TOPICAL 19870919 OTC MONOGRAPH FINAL part358F Sato Pharmaceutical Co., Ltd. SALICYLIC ACID 12 g/100mL 49873-082_721839e1-b042-4fb5-8521-14fffcb07986 49873-082 HUMAN OTC DRUG Ringl acetaminophen TABLET ORAL 19960509 OTC MONOGRAPH NOT FINAL part343 Sato Pharmaceutical Co., Ltd. ACETAMINOPHEN 325 mg/1 49873-108_f5908e0e-36a9-4b3b-a8f2-49fe123d3b93 49873-108 HUMAN OTC DRUG Stona for Children acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide SYRUP ORAL 20010103 OTC MONOGRAPH FINAL part341 Sato Pharmaceutical Co., Ltd. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 325; 2; 10 mg/15mL; mg/15mL; mg/15mL 49873-109_20f87fac-72d0-4e4e-8afa-87a80f375383 49873-109 HUMAN OTC DRUG Stonarhini Chlorpheniramine maleate, phenylephrine TABLET ORAL 20011116 OTC MONOGRAPH FINAL part341 Sato Pharmaceutical Co., Ltd. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 2; 5 mg/1; mg/1 49873-113_70dbe076-5102-4129-862e-036808955b12 49873-113 HUMAN OTC DRUG Stona-S acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride CAPSULE ORAL 20040927 OTC MONOGRAPH FINAL part341 Sato Pharmaceutical Co., Ltd. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 162.5; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 49873-114_43202695-5e1e-4d0f-887c-4df5b40fbd3b 49873-114 HUMAN OTC DRUG Stona acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride TABLET ORAL 20040929 OTC MONOGRAPH FINAL part341 Sato Pharmaceutical Co., Ltd. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 162.5; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 49873-301_ab10a7df-15de-4d89-8f7b-661520fc2b0f 49873-301 HUMAN OTC DRUG Stona Troche dextromethorphan hydrobromide LOZENGE ORAL 19951119 OTC MONOGRAPH NOT FINAL part341 Sato Pharmaceutical Co., Ltd. DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 49873-302_2f28c7bd-ca49-4d95-970e-6bbc06d38a45 49873-302 HUMAN OTC DRUG Stona Cough dextromethorphan hydrobromide, guaifenesin SYRUP ORAL 20010103 OTC MONOGRAPH FINAL part341 Sato Pharmaceutical Co., Ltd. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30; 200 mg/10mL; mg/10mL 49873-306_7a0a91e3-c25e-40a9-8e43-13afc350baaf 49873-306 HUMAN OTC DRUG Stona Cough dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride TABLET ORAL 20041124 OTC MONOGRAPH FINAL part341 Sato Pharmaceutical Co., Ltd. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 100; 5 mg/1; mg/1; mg/1 49873-401_a32f01b5-42f2-4dad-b87e-587b22e13d9f 49873-401 HUMAN OTC DRUG MINICA-S glycerin ENEMA RECTAL 19940501 OTC MONOGRAPH NOT FINAL part334 Sato Pharmaceutical Co., Ltd. GLYCERIN 80 mL/100mL 49873-402_17456a04-7ddd-4f8f-9716-1ecb5807c09e 49873-402 HUMAN OTC DRUG Inon Ace magnesium aluminosilicates, magnesium hydroxide, simethicone TABLET ORAL 19951101 OTC MONOGRAPH FINAL part331 Sato Pharmaceutical Co., Ltd. DIMETHICONE; MAGNESIUM HYDROXIDE; SILODRATE 20; 60; 200 mg/1; mg/1; mg/1 49873-403_e9fd320a-7ceb-4095-9437-e68e9e6a914e 49873-403 HUMAN OTC DRUG Inon Ace magnesium aluminosilicate, magnesium hydroxide SOLUTION ORAL 20000520 OTC MONOGRAPH FINAL part331 Sato Pharmaceutical Co., Ltd. MAGNESIUM HYDROXIDE; SILODRATE 250; 900 mg/30mL; mg/30mL 49873-404_708062f0-942b-4d10-b935-1497b8ec4b90 49873-404 HUMAN OTC DRUG Sankaijo docusate sodium, sennosides TABLET ORAL 20021220 OTC MONOGRAPH NOT FINAL part334 Sato Pharmaceutical Co., Ltd. DOCUSATE SODIUM; SENNOSIDES 8.33; 1.36 mg/1; mg/1 49873-501_3639b8df-0b0f-4f36-bd3c-73f222b71b53 49873-501 HUMAN OTC DRUG Optic Splash naphazoline hydrochloride, glycerin SOLUTION/ DROPS OPHTHALMIC 20080122 OTC MONOGRAPH FINAL part349 Sato Pharmaceutical, Co., Ltd. GLYCERIN; NAPHAZOLINE HYDROCHLORIDE 200; 20 mg/100mL; mg/100mL 49873-608_bc960609-8e02-49c7-ab99-95fd84b3783f 49873-608 HUMAN OTC DRUG Satogesic Hot capsaicin PATCH TOPICAL 20061122 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Co., Ltd. CAPSAICIN .25 mg/1 49873-703_d6d1a3ec-2c2a-4823-bd1b-d495542f1ec3 49873-703 HUMAN OTC DRUG Poli-A hydrocortisone acetate OINTMENT TOPICAL 19950319 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Co., Ltd. HYDROCORTISONE ACETATE 1 g/100g 49873-704_a0e6cca1-cad5-4622-8735-04e0239a1abd 49873-704 HUMAN OTC DRUG Tact Cool Jelly diphenhydramine hydrochloride, levomenthol GEL TOPICAL 19971002 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Co., Ltd. DIPHENHYDRAMINE HYDROCHLORIDE; LEVOMENTHOL 2; 1 g/100g; g/100g 49873-705_f88439ae-d9ee-45e7-aae1-165c4bbf2cc8 49873-705 HUMAN OTC DRUG TACT diphenhydramine hydrochloride, menthol CREAM TOPICAL 19970909 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Inc., Ltd. DIPHENHYDRAMINE HYDROCHLORIDE; LEVOMENTHOL 2; 1 g/100g; g/100g 49873-802_165c3555-b0bf-4b7a-9beb-bb8960f6829a 49873-802 HUMAN OTC DRUG Airmit Ace dimenhydrinate TABLET ORAL 20050311 OTC MONOGRAPH FINAL part336 Sato Pharmaceutical Co., Ltd. DIMENHYDRINATE 25 mg/1 49873-803_cff56526-56de-4a8f-a5a5-b4220e3d8ab8 49873-803 HUMAN OTC DRUG Zentrip meclizine hydrochloride FILM, SOLUBLE ORAL 20090203 OTC MONOGRAPH FINAL part336 Sato Pharmaceutical Co., Ltd. MECLIZINE HYDROCHLORIDE 25 mg/1 49877-006_5dc51c6f-3311-4bef-8a88-3e825d205777 49877-006 HUMAN OTC DRUG Goldlove Hand Sanitizer None Hand Sanitizer LIQUID TOPICAL 20091110 OTC MONOGRAPH FINAL part333 Cixi Zhixin Bird Clean-care Product Co., Ltd. ALCOHOL 62 g/100g 49877-011_cc0e831d-9fa0-402c-9118-393376e65734 49877-011 HUMAN OTC DRUG Ultracruz Antibacterial None BENZALKONIUM CHLORIDE LOTION TOPICAL 20140822 OTC MONOGRAPH NOT FINAL part333A Cixi Zhixin Bird Clean-care Product Co., Ltd. BENZALKONIUM CHLORIDE .1 g/100mL 49877-012_b163da89-3588-4aac-8c97-1e2af1479ef7 49877-012 HUMAN OTC DRUG Ultracruz Antibacterial Hand None BENZALKONIUM CHLORIDE SOAP TOPICAL 20140822 OTC MONOGRAPH NOT FINAL part333A Cixi Zhixin Bird Clean-care Product Co., Ltd. BENZALKONIUM CHLORIDE .1 g/100mL 49882-0929_1519f7e2-94da-4e60-a317-617bbcce4794 49882-0929 HUMAN OTC DRUG SKILCRAFT Anti-bacterial Wipes SKILCRAFT Anti-bacterial Wipes CLOTH TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Winston Salem Industries for the Blind, Inc. BENZALKONIUM CHLORIDE; BENZETHONIUM CHLORIDE .1; .1 g/970mL; g/970mL 49884-009_aecc0406-e209-4217-b997-583b444292ee 49884-009 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19830210 ANDA ANDA087946 Par Pharmaceutical Inc. ISOSORBIDE DINITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 49884-019_8ce4cf02-1bae-419d-8626-c9f15eb8f7b6 49884-019 HUMAN PRESCRIPTION DRUG Omega-3-Acid Ethyl Esters omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20140630 ANDA ANDA091018 Par Pharmaceutical, Inc. OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] 49884-020_aecc0406-e209-4217-b997-583b444292ee 49884-020 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19791213 ANDA ANDA086923 Par Pharmaceutical Inc. ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 49884-021_aecc0406-e209-4217-b997-583b444292ee 49884-021 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19791222 ANDA ANDA086925 Par Pharmaceutical Inc. ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 49884-022_aecc0406-e209-4217-b997-583b444292ee 49884-022 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19811215 ANDA ANDA087537 Par Pharmaceutical Inc. ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 49884-027_c251838d-4e23-44dc-ab58-46c161ebde90 49884-027 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19800227 ANDA ANDA086961 Par Pharmaceutical, Inc. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 49884-028_c251838d-4e23-44dc-ab58-46c161ebde90 49884-028 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19800227 ANDA ANDA086962 Par Pharmaceutical, Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 49884-029_c251838d-4e23-44dc-ab58-46c161ebde90 49884-029 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19821005 ANDA ANDA087836 Par Pharmaceutical, Inc. HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 49884-032_b7845906-fc48-45b5-9539-d73e7ebef163 49884-032 HUMAN PRESCRIPTION DRUG Tranylcypromine Sulfate tranylcypromine sulfate TABLET ORAL 20060630 ANDA ANDA040640 Par Pharmaceutical, Inc. TRANYLCYPROMINE SULFATE 10 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] 49884-034_cc3b9ad0-5400-454f-9e7f-af385dacce0f 49884-034 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087127 Par Pharmaceutical, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 49884-035_cc3b9ad0-5400-454f-9e7f-af385dacce0f 49884-035 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087128 Par Pharmaceutical, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 49884-044_351a26fc-a896-4565-b413-4fe9f48ecfff 49884-044 HUMAN PRESCRIPTION DRUG Travoprost Ophthalmic Solution 0.004% travoprost SOLUTION OPHTHALMIC 20130415 ANDA ANDA091340 Par Pharmaceutical, Inc. TRAVOPROST .04 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 49884-054_d2b994fa-8620-42cd-b436-0f7dcffb2e09 49884-054 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19831021 ANDA ANDA088292 Par Pharmaceutical Inc. IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 49884-055_d2b994fa-8620-42cd-b436-0f7dcffb2e09 49884-055 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19831021 ANDA ANDA088262 Par Pharmaceutical Inc. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 49884-056_d2b994fa-8620-42cd-b436-0f7dcffb2e09 49884-056 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19831021 ANDA ANDA088276 Par Pharmaceutical Inc. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 49884-065_99270376-6f81-4e2c-befc-9cbf1f93ae3b 49884-065 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20060926 ANDA ANDA040653 Par Pharmaceutical Inc. GLYCOPYRROLATE 1 mg/1 49884-066_99270376-6f81-4e2c-befc-9cbf1f93ae3b 49884-066 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20060926 ANDA ANDA040653 Par Pharmaceutical Inc. GLYCOPYRROLATE 2 mg/1 49884-071_236331c9-bb2f-4e9f-b90e-b0d52e1bd37e 49884-071 HUMAN PRESCRIPTION DRUG RIBASPHERE RibaPak ribavirin KIT 20051206 ANDA ANDA077456 PAR Pharmaceutical Companies, Inc. 49884-084_85a9eebb-be74-43a1-a36f-26ae4c4131aa 49884-084 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088148 Par Pharmaceutical Inc. DEXAMETHASONE .5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49884-085_85a9eebb-be74-43a1-a36f-26ae4c4131aa 49884-085 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088160 Par Pharmaceutical Inc. DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49884-086_85a9eebb-be74-43a1-a36f-26ae4c4131aa 49884-086 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088237 Par Pharmaceutical Inc. DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49884-087_85a9eebb-be74-43a1-a36f-26ae4c4131aa 49884-087 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088238 Par Pharmaceutical Inc. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49884-091_e01dc959-0301-4a6c-99cf-730fdcb2642e 49884-091 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline TABLET ORAL 20001215 ANDA ANDA065070 Par Pharmaceutical Inc DOXYCYCLINE 50 mg/1 49884-092_e01dc959-0301-4a6c-99cf-730fdcb2642e 49884-092 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline TABLET ORAL 20001215 ANDA ANDA065070 Par Pharmaceutical Inc DOXYCYCLINE 75 mg/1 49884-093_e01dc959-0301-4a6c-99cf-730fdcb2642e 49884-093 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline TABLET ORAL 20001215 ANDA ANDA065070 Par Pharmaceutical Inc DOXYCYCLINE 100 mg/1 49884-096_3bb7df02-5222-4765-b0ba-2a7c8f41e98d 49884-096 HUMAN PRESCRIPTION DRUG DYNACIN Minocycline Hydrochloride TABLET ORAL 20110620 ANDA ANDA065131 Par Pharmaceutical, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 49884-097_3bb7df02-5222-4765-b0ba-2a7c8f41e98d 49884-097 HUMAN PRESCRIPTION DRUG DYNACIN Minocycline Hydrochloride TABLET ORAL 20110620 ANDA ANDA065131 Par Pharmaceutical, Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 49884-098_3bb7df02-5222-4765-b0ba-2a7c8f41e98d 49884-098 HUMAN PRESCRIPTION DRUG DYNACIN Minocycline Hydrochloride TABLET ORAL 20110620 ANDA ANDA065131 Par Pharmaceutical, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 49884-099_fbe3f652-a8f2-42cc-9519-ef36bda011f8 49884-099 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110103 ANDA ANDA078540 Par Pharmaceutical, Inc. PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] 49884-104_5fd8e97c-7e56-4410-920d-92cd2182a4fd 49884-104 HUMAN PRESCRIPTION DRUG Entecavir entecavir TABLET, FILM COATED ORAL 20140818 NDA NDA021797 Par Pharmaceutical, Inc. ENTECAVIR .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49884-105_5fd8e97c-7e56-4410-920d-92cd2182a4fd 49884-105 HUMAN PRESCRIPTION DRUG Entecavir entecavir TABLET, FILM COATED ORAL 20140818 NDA NDA021797 Par Pharmaceutical, Inc. ENTECAVIR 1 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 49884-106_5a0a5577-e7f8-455c-9dde-68a5d07b85a2 49884-106 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20090127 ANDA ANDA079234 Par Pharmaceutical Inc TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 49884-107_5a0a5577-e7f8-455c-9dde-68a5d07b85a2 49884-107 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20090127 ANDA ANDA079234 Par Pharmaceutical Inc TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 49884-108_5a0a5577-e7f8-455c-9dde-68a5d07b85a2 49884-108 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20090127 ANDA ANDA079234 Par Pharmaceutical Inc TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 49884-109_5a0a5577-e7f8-455c-9dde-68a5d07b85a2 49884-109 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20090127 ANDA ANDA079234 Par Pharmaceutical Inc TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 49884-110_3055c328-c249-4f49-9b03-a4b114db17b6 49884-110 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20090109 ANDA ANDA078088 Par Pharmaceutical Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49884-111_3055c328-c249-4f49-9b03-a4b114db17b6 49884-111 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20090109 ANDA ANDA078088 Par Pharmaceutical Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49884-117_68b34ecb-6273-4b57-85cf-007e4f64c0b8 49884-117 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride Amiloride Hydrochloride TABLET ORAL 19860122 ANDA ANDA070346 Par Pharmaceutical Inc. AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 49884-121_c251838d-4e23-44dc-ab58-46c161ebde90 49884-121 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19830927 ANDA ANDA088391 Par Pharmaceutical, Inc. HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 49884-122_51d5f0db-e965-43bb-a983-e4a7a43c54d9 49884-122 HUMAN PRESCRIPTION DRUG Labetalol HCL Labetalol Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA200908 Par Pharmaceutical Companies, Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49884-123_51d5f0db-e965-43bb-a983-e4a7a43c54d9 49884-123 HUMAN PRESCRIPTION DRUG Labetalol HCL Labetalol Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA200908 Par Pharmaceutical Companies, Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49884-124_51d5f0db-e965-43bb-a983-e4a7a43c54d9 49884-124 HUMAN PRESCRIPTION DRUG Labetalol HCL Labetalol Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA200908 Par Pharmaceutical Companies, Inc. LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49884-129_85a9eebb-be74-43a1-a36f-26ae4c4131aa 49884-129 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19831128 ANDA ANDA088481 Par Pharmaceutical Inc. DEXAMETHASONE 6 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49884-136_72274f64-50eb-4725-bf20-5c05e2784154 49884-136 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Par Pharmaceutical Companies, Inc OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-137_72274f64-50eb-4725-bf20-5c05e2784154 49884-137 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Par Pharmaceutical Companies, Inc OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-138_72274f64-50eb-4725-bf20-5c05e2784154 49884-138 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Par Pharmaceutical Companies, Inc OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-157_9dd54407-c7ba-49fe-b8ef-0f628654fc2d 49884-157 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SPRAY, METERED NASAL 20141021 NDA AUTHORIZED GENERIC NDA020746 Par Pharmaceutical Inc. BUDESONIDE 32 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49884-161_35e3dd68-677f-45e9-b4bf-f30fa2a34367 49884-161 HUMAN PRESCRIPTION DRUG CALCITONIN SALMON CALCITONIN SALMON SPRAY, METERED NASAL 20090608 ANDA ANDA076979 Par Pharmaceutical Inc. (mgc) CALCITONIN SALMON 200 [iU]/.09mL Calcitonin [Chemical/Ingredient],Calcitonin [EPC] 49884-195_118b3ae8-4aa3-421c-b3d1-1781edefe739 49884-195 HUMAN PRESCRIPTION DRUG Nabumetone nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Par Pharmaceutical Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49884-196_118b3ae8-4aa3-421c-b3d1-1781edefe739 49884-196 HUMAN PRESCRIPTION DRUG Nabumetone nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Par Pharmaceutical Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49884-197_72274f64-50eb-4725-bf20-5c05e2784154 49884-197 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Par Pharmaceutical Companies, Inc OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-204_8b278c49-8e40-4873-b73d-d5a4a3d6ee3a 49884-204 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, EXTENDED RELEASE ORAL 20110913 ANDA ANDA091291 Par Pharmaceutical Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49884-205_8b278c49-8e40-4873-b73d-d5a4a3d6ee3a 49884-205 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, EXTENDED RELEASE ORAL 20110913 ANDA ANDA091291 Par Pharmaceutical Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49884-210_fbe3f652-a8f2-42cc-9519-ef36bda011f8 49884-210 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110103 ANDA ANDA078540 Par Pharmaceutical, Inc. PROPAFENONE HYDROCHLORIDE 325 mg/1 Antiarrhythmic [EPC] 49884-211_fbe3f652-a8f2-42cc-9519-ef36bda011f8 49884-211 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110103 ANDA ANDA078540 Par Pharmaceutical, Inc. PROPAFENONE HYDROCHLORIDE 425 mg/1 Antiarrhythmic [EPC] 49884-212_da7ff262-9191-4f4e-96f6-40753b126db9 49884-212 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20090601 ANDA ANDA077494 Par Pharmaceutical Companies, Inc. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 49884-213_3055c328-c249-4f49-9b03-a4b114db17b6 49884-213 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20090109 ANDA ANDA078088 Par Pharmaceutical Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49884-214_3055c328-c249-4f49-9b03-a4b114db17b6 49884-214 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20090109 ANDA ANDA078088 Par Pharmaceutical Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49884-222_c88b0b6c-77eb-4997-8704-190e97214392 49884-222 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 19871109 ANDA ANDA071669 Par Pharmaceutical Inc DOXEPIN HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 49884-232_afb67cda-aca1-4fdc-aa68-472e8253816b 49884-232 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET ORAL 20130915 ANDA ANDA202542 Par Pharmaceutical, Inc. DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 49884-235_b3fb3fda-47c0-4666-8e3e-0e255a5cef01 49884-235 HUMAN PRESCRIPTION DRUG Hydrocodone Polistirex and Chlorpheniramine Polisitrex Hydrocodone Polistirex and Chlorpheniramine Polisitrex SUSPENSION, EXTENDED RELEASE ORAL 20120816 ANDA ANDA091632 Par Pharmaceutical Companies Inc CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE 8; 10 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII 49884-236_e01dc959-0301-4a6c-99cf-730fdcb2642e 49884-236 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline TABLET ORAL 20001215 ANDA ANDA065070 Par Pharmaceutical Inc DOXYCYCLINE 150 mg/1 49884-250_ea1113b0-50f1-4b4f-8e19-a7e066381de2 49884-250 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine olanzapine and fuoxetine CAPSULE ORAL 20121128 ANDA ANDA077742 Par Pharmaceutical, Inc FLUOXETINE HYDROCHLORIDE; OLANZAPINE 25; 6 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49884-251_ea1113b0-50f1-4b4f-8e19-a7e066381de2 49884-251 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine olanzapine and fuoxetine CAPSULE ORAL 20121128 ANDA ANDA077742 Par Pharmaceutical, Inc FLUOXETINE HYDROCHLORIDE; OLANZAPINE 50; 6 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49884-252_ea1113b0-50f1-4b4f-8e19-a7e066381de2 49884-252 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine olanzapine and fuoxetine CAPSULE ORAL 20121128 ANDA ANDA077742 Par Pharmaceutical, Inc FLUOXETINE HYDROCHLORIDE; OLANZAPINE 25; 12 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49884-253_ea1113b0-50f1-4b4f-8e19-a7e066381de2 49884-253 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine olanzapine and fuoxetine CAPSULE ORAL 20121128 ANDA ANDA077742 Par Pharmaceutical, Inc FLUOXETINE HYDROCHLORIDE; OLANZAPINE 50; 12 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49884-256_9e2fa5e7-1087-46ea-bf5f-4fd5963b4bb4 49884-256 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 19881114 ANDA ANDA071826 Par Pharmaceutical Inc MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 49884-257_9e2fa5e7-1087-46ea-bf5f-4fd5963b4bb4 49884-257 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 19881114 ANDA ANDA071839 Par Pharmaceutical Inc MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 49884-258_940eb5dd-d90d-4dd2-b67b-e3e1058863c0 49884-258 HUMAN PRESCRIPTION DRUG Metaproterenol Sulfate Metaproterenol Sulfate TABLET ORAL 19880628 ANDA ANDA072024 Par Pharmaceutical Inc METAPROTERENOL SULFATE 10 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 49884-259_940eb5dd-d90d-4dd2-b67b-e3e1058863c0 49884-259 HUMAN PRESCRIPTION DRUG Metaproterenol Sulfate Metaproterenol Sulfate TABLET ORAL 19880628 ANDA ANDA072025 Par Pharmaceutical Inc METAPROTERENOL SULFATE 20 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 49884-265_aa5d4728-5548-4db0-8d36-4cd70950dabf 49884-265 HUMAN PRESCRIPTION DRUG Chlordiazepoxide and Amitriptyline HCl Chlordiazepoxide and Amitriptyline hydrochloride TABLET ORAL 19880509 ANDA ANDA072277 Par Pharmaceutical Inc AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE 12.5; 5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] CIV 49884-266_aa5d4728-5548-4db0-8d36-4cd70950dabf 49884-266 HUMAN PRESCRIPTION DRUG Chlordiazepoxide and Amitriptyline HCl Chlordiazepoxide and Amitriptyline hydrochloride TABLET ORAL 19880509 ANDA ANDA072278 Par Pharmaceutical Inc AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE 25; 10 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] CIV 49884-270_697e0e52-c01b-4b53-9994-f79c46eb6b4f 49884-270 HUMAN PRESCRIPTION DRUG Nascobal cyanocobalamin SPRAY NASAL 20090813 NDA NDA021642 Par Pharmaceutical , Inc CYANOCOBALAMIN 500 ug/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 49884-270_9292283e-ddd6-4dae-99bc-fcfa5d55d898 49884-270 HUMAN PRESCRIPTION DRUG Nascobal cyanocobalamin SPRAY NASAL 20090813 NDA NDA021642 Par Pharmaceutical , Inc CYANOCOBALAMIN 500 ug/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 49884-277_ea1113b0-50f1-4b4f-8e19-a7e066381de2 49884-277 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine olanzapine and fuoxetine CAPSULE ORAL 20121128 ANDA ANDA077742 Par Pharmaceutical, Inc FLUOXETINE HYDROCHLORIDE; OLANZAPINE 25; 3 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49884-289_4d35bf99-05d4-43f9-ace7-967137a657d9 49884-289 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19880808 ANDA ANDA072422 Par Pharmaceutical Inc MEGESTROL ACETATE 20 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 49884-290_4d35bf99-05d4-43f9-ace7-967137a657d9 49884-290 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19880808 ANDA ANDA072423 Par Pharmaceutical Inc MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 49884-301_81616869-97ac-4972-91d0-42c93519f346 49884-301 HUMAN PRESCRIPTION DRUG Oxandrolone oxandrolone TABLET ORAL 20070820 ANDA ANDA077827 Par Pharmaceutical Inc. OXANDROLONE 2.5 mg/1 CIII 49884-302_81616869-97ac-4972-91d0-42c93519f346 49884-302 HUMAN PRESCRIPTION DRUG Oxandrolone oxandrolone TABLET ORAL 20070820 ANDA ANDA077827 Par Pharmaceutical Inc. OXANDROLONE 10 mg/1 CIII 49884-303_0054eaea-2145-4ad9-a16a-084841cbc0a9 49884-303 HUMAN PRESCRIPTION DRUG ZAFIRLUKAST Zafirlukast TABLET, FILM COATED ORAL 20101201 NDA NDA020547 Par Pharmaceutical Inc. ZAFIRLUKAST 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 49884-304_0054eaea-2145-4ad9-a16a-084841cbc0a9 49884-304 HUMAN PRESCRIPTION DRUG ZAFIRLUKAST Zafirlukast TABLET, FILM COATED ORAL 20101201 NDA NDA020547 Par Pharmaceutical Inc. ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 49884-305_24fcbfc8-ad92-4bb3-8ee4-606ecbee1ff0 49884-305 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20110601 ANDA ANDA065055 Par Pharmaceutical Inc. DOXYCYCLINE 150 mg/1 49884-306_2180e1ea-d37e-4b53-a57a-34a7c1a1a352 49884-306 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050805 ANDA ANDA077171 Par Pharmaceutical, Inc. CLONAZEPAM .125 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49884-307_2180e1ea-d37e-4b53-a57a-34a7c1a1a352 49884-307 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050805 ANDA ANDA077171 Par Pharmaceutical, Inc. CLONAZEPAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49884-308_2180e1ea-d37e-4b53-a57a-34a7c1a1a352 49884-308 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050805 ANDA ANDA077171 Par Pharmaceutical, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49884-309_2180e1ea-d37e-4b53-a57a-34a7c1a1a352 49884-309 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050805 ANDA ANDA077171 Par Pharmaceutical, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49884-310_2180e1ea-d37e-4b53-a57a-34a7c1a1a352 49884-310 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050805 ANDA ANDA077171 Par Pharmaceutical, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49884-311_da7ff262-9191-4f4e-96f6-40753b126db9 49884-311 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20090601 ANDA ANDA077494 Par Pharmaceutical Companies, Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 49884-315_da7ff262-9191-4f4e-96f6-40753b126db9 49884-315 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091026 ANDA ANDA077494 Par Pharmaceutical Companies, Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 49884-320_08881ac7-eb8a-43ce-880d-1c3b2566f9cd 49884-320 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA078109 Par Pharmaceutical, Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 49884-321_08881ac7-eb8a-43ce-880d-1c3b2566f9cd 49884-321 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA078109 Par Pharmaceutical, Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 49884-322_08881ac7-eb8a-43ce-880d-1c3b2566f9cd 49884-322 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA078109 Par Pharmaceutical, Inc. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 49884-323_08881ac7-eb8a-43ce-880d-1c3b2566f9cd 49884-323 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA078109 Par Pharmaceutical, Inc. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 49884-338_236331c9-bb2f-4e9f-b90e-b0d52e1bd37e 49884-338 HUMAN PRESCRIPTION DRUG RIBASPHERE RibaPak ribavirin TABLET ORAL 20051206 ANDA ANDA077456 PAR Pharmaceutical Companies, Inc. RIBAVIRIN 400 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 49884-340_236331c9-bb2f-4e9f-b90e-b0d52e1bd37e 49884-340 HUMAN PRESCRIPTION DRUG RIBASPHERE RibaPak ribavirin TABLET ORAL 20051206 ANDA ANDA077456 PAR Pharmaceutical Companies, Inc. RIBAVIRIN 600 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 49884-374_bf7c38d6-3cba-42dd-a439-ed28c34789c3 49884-374 HUMAN PRESCRIPTION DRUG KHEDEZLA Extended-release desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20130710 NDA NDA204683 Par Pharmaceutical Inc. DESVENLAFAXINE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 49884-375_bf7c38d6-3cba-42dd-a439-ed28c34789c3 49884-375 HUMAN PRESCRIPTION DRUG KHEDEZLA Extended-release desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20130710 NDA NDA204683 Par Pharmaceutical Inc. DESVENLAFAXINE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 49884-397_52a9785f-5713-442e-9f9f-9fe34435b004 49884-397 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20100701 ANDA ANDA078966 Par Pharmaceutical Inc. OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 49884-401_da7ff262-9191-4f4e-96f6-40753b126db9 49884-401 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20090601 ANDA ANDA077494 Par Pharmaceutical Companies, Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 49884-402_da7ff262-9191-4f4e-96f6-40753b126db9 49884-402 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20090601 ANDA ANDA077494 Par Pharmaceutical Companies, Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 49884-403_da7ff262-9191-4f4e-96f6-40753b126db9 49884-403 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20090601 ANDA ANDA077494 Par Pharmaceutical Companies, Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 49884-404_df93dd59-b3f7-438c-8331-39c1dfed4bb9 49884-404 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20061121 NDA AUTHORIZED GENERIC NDA019962 Par Pharmaceutical Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49884-405_df93dd59-b3f7-438c-8331-39c1dfed4bb9 49884-405 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20070802 NDA AUTHORIZED GENERIC NDA019962 Par Pharmaceutical Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49884-406_df93dd59-b3f7-438c-8331-39c1dfed4bb9 49884-406 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20070726 NDA AUTHORIZED GENERIC NDA019962 Par Pharmaceutical Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49884-407_df93dd59-b3f7-438c-8331-39c1dfed4bb9 49884-407 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20070726 NDA AUTHORIZED GENERIC NDA019962 Par Pharmaceutical Inc. METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49884-412_21151543-f0bc-4bfd-9a78-86b1cc7987b0 49884-412 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET, FILM COATED ORAL 20130801 ANDA ANDA202540 Par Pharmaceutical Companies, Inc. URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 49884-413_21151543-f0bc-4bfd-9a78-86b1cc7987b0 49884-413 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET, FILM COATED ORAL 20130801 ANDA ANDA202540 Par Pharmaceutical Companies, Inc. URSODIOL 500 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 49884-428_70333876-db42-42de-b737-874adfd32001 49884-428 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20131119 ANDA ANDA078992 Par Pharmaceutical Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 49884-430_70333876-db42-42de-b737-874adfd32001 49884-430 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20131119 ANDA ANDA078992 Par Pharmaceutical Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 49884-455_52a9785f-5713-442e-9f9f-9fe34435b004 49884-455 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20100701 ANDA ANDA078966 Par Pharmaceutical Inc. OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 49884-459_8adeb704-76ec-491b-af20-bc839e7f26f8 49884-459 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20111017 ANDA ANDA077312 Par Pharmaceutical Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-460_8adeb704-76ec-491b-af20-bc839e7f26f8 49884-460 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20111017 ANDA ANDA077312 Par Pharmaceutical Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-461_8adeb704-76ec-491b-af20-bc839e7f26f8 49884-461 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20111017 ANDA ANDA077312 Par Pharmaceutical Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-462_8adeb704-76ec-491b-af20-bc839e7f26f8 49884-462 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20111017 ANDA ANDA077312 Par Pharmaceutical Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-463_8adeb704-76ec-491b-af20-bc839e7f26f8 49884-463 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20111017 ANDA ANDA077312 Par Pharmaceutical Inc. FENTANYL CITRATE 1200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-464_8adeb704-76ec-491b-af20-bc839e7f26f8 49884-464 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20111017 ANDA ANDA077312 Par Pharmaceutical Inc. FENTANYL CITRATE 1600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-465_f4f7b671-fa9d-42f1-98f4-ad55c8d9ebcc 49884-465 HUMAN PRESCRIPTION DRUG Cholestyramine cholestyramine POWDER, FOR SUSPENSION ORAL 20050915 ANDA ANDA077204 Par Pharmaceutical, Inc. CHOLESTYRAMINE 4 g/9g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 49884-466_f4f7b671-fa9d-42f1-98f4-ad55c8d9ebcc 49884-466 HUMAN PRESCRIPTION DRUG Cholestyramine cholestyramine POWDER, FOR SUSPENSION ORAL 20050915 ANDA ANDA077203 Par Pharmaceutical, Inc. CHOLESTYRAMINE 4 g/5g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 49884-494_52373737-f92c-43e7-b1c1-7b87f7b415cf 49884-494 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20140114 NDA AUTHORIZED GENERIC NDA020405 Par Pharmaceutical, Inc DIGOXIN .25 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 49884-501_6f5e0c8c-0697-4975-88a6-0c88b29f0f30 49884-501 HUMAN PRESCRIPTION DRUG Budesonide Budesonide CAPSULE ORAL 20110818 NDA AUTHORIZED GENERIC NDA021324 Par Pharmaceutical Inc. BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49884-511_f70125c0-1b45-4c84-85fb-25cb7ed9d0b1 49884-511 HUMAN PRESCRIPTION DRUG Minocycline Minocycline TABLET ORAL 20030416 ANDA ANDA065131 Par Pharmaceutical, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 49884-512_f70125c0-1b45-4c84-85fb-25cb7ed9d0b1 49884-512 HUMAN PRESCRIPTION DRUG Minocycline Minocycline TABLET ORAL 20030416 ANDA ANDA065131 Par Pharmaceutical, Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 49884-513_f70125c0-1b45-4c84-85fb-25cb7ed9d0b1 49884-513 HUMAN PRESCRIPTION DRUG Minocycline Minocycline TABLET ORAL 20030416 ANDA ANDA065131 Par Pharmaceutical, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 49884-514_52373737-f92c-43e7-b1c1-7b87f7b415cf 49884-514 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20140114 NDA AUTHORIZED GENERIC NDA020405 Par Pharmaceutical, Inc DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 49884-534_ce11f774-fa87-428d-9493-1d69bcb7ab98 49884-534 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20120406 NDA AUTHORIZED GENERIC NDA020717 Par Pharmaceutical Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 49884-535_ce11f774-fa87-428d-9493-1d69bcb7ab98 49884-535 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20120406 NDA AUTHORIZED GENERIC NDA020717 Par Pharmaceutical Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 49884-545_58cf38c1-73f8-47a9-b710-cfe6faa44f59 49884-545 HUMAN PRESCRIPTION DRUG Ranitidine ranitidine TABLET ORAL 19990128 ANDA ANDA075180 Par Pharmaceutical Inc RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 49884-561_fdecbb5c-187e-4c67-b1b3-336389946675 49884-561 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20130118 ANDA ANDA201791 Par Pharmaceutical Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49884-562_fdecbb5c-187e-4c67-b1b3-336389946675 49884-562 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20130118 ANDA ANDA201791 Par Pharmaceutical Inc. LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49884-563_fdecbb5c-187e-4c67-b1b3-336389946675 49884-563 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20130118 ANDA ANDA201791 Par Pharmaceutical Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49884-564_fdecbb5c-187e-4c67-b1b3-336389946675 49884-564 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20130118 ANDA ANDA201791 Par Pharmaceutical Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49884-574_2f4c8bb3-ed66-43c1-8d9b-6858543608c9 49884-574 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan amlodipine and valsartan TABLET ORAL 20140930 ANDA ANDA090011 Par Pharmaceutical, Inc. AMLODIPINE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49884-575_2f4c8bb3-ed66-43c1-8d9b-6858543608c9 49884-575 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan amlodipine and valsartan TABLET ORAL 20140930 ANDA ANDA090011 Par Pharmaceutical, Inc. AMLODIPINE; VALSARTAN 10; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49884-576_2f4c8bb3-ed66-43c1-8d9b-6858543608c9 49884-576 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan amlodipine and valsartan TABLET ORAL 20140930 ANDA ANDA090144 Par Pharmaceutical, Inc. AMLODIPINE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49884-577_2f4c8bb3-ed66-43c1-8d9b-6858543608c9 49884-577 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan amlodipine and valsartan TABLET ORAL 20140930 ANDA ANDA090011 Par Pharmaceutical, Inc. AMLODIPINE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49884-578_b03a0c76-2cea-473a-9fc8-73d7015ee54e 49884-578 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET ORAL 19980629 NDA NDA020864 Par Pharmaceutical Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 49884-579_b03a0c76-2cea-473a-9fc8-73d7015ee54e 49884-579 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET ORAL 19980629 NDA NDA020864 Par Pharmaceutical Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 49884-580_b03a0c76-2cea-473a-9fc8-73d7015ee54e 49884-580 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 19980629 NDA NDA020865 Par Pharmaceutical Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 49884-581_b03a0c76-2cea-473a-9fc8-73d7015ee54e 49884-581 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 19980629 NDA NDA020865 Par Pharmaceutical Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 49884-604_fdecbb5c-187e-4c67-b1b3-336389946675 49884-604 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20130118 ANDA ANDA201791 Par Pharmaceutical Inc. LAMOTRIGINE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49884-605_fdecbb5c-187e-4c67-b1b3-336389946675 49884-605 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20130118 ANDA ANDA201791 Par Pharmaceutical Inc. LAMOTRIGINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49884-640_e65f5462-87b6-4c53-956d-491f86827b45 49884-640 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20120228 ANDA ANDA040350 Par Pharmaceutical Inc METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 49884-641_e65f5462-87b6-4c53-956d-491f86827b45 49884-641 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20120228 ANDA ANDA040350 Par Pharmaceutical Inc METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 49884-649_50f25fa8-0197-4a4b-93c8-64455aa0d697 49884-649 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20030124 ANDA ANDA076009 Par Pharmaceutical Inc NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49884-650_50f25fa8-0197-4a4b-93c8-64455aa0d697 49884-650 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20030124 ANDA ANDA076009 Par Pharmaceutical Inc NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49884-658_0bca6ec3-e9c6-4e72-a0e7-8ea80891e9c1 49884-658 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 NDA AUTHORIZED GENERIC NDA020838 Par Pharmaceutical Inc. CANDESARTAN CILEXETIL 4 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49884-659_0bca6ec3-e9c6-4e72-a0e7-8ea80891e9c1 49884-659 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 NDA AUTHORIZED GENERIC NDA020838 Par Pharmaceutical Inc. CANDESARTAN CILEXETIL 8 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49884-660_0bca6ec3-e9c6-4e72-a0e7-8ea80891e9c1 49884-660 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 NDA AUTHORIZED GENERIC NDA020838 Par Pharmaceutical Inc. CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49884-661_0bca6ec3-e9c6-4e72-a0e7-8ea80891e9c1 49884-661 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 NDA AUTHORIZED GENERIC NDA020838 Par Pharmaceutical Inc. CANDESARTAN CILEXETIL 32 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49884-662_106159ae-4ee6-4dc8-bfc5-87e1f6b5531d 49884-662 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil-Hydrochlorothiazide Candesartan Cilexetil and Hydrochlorothiazide TABLET ORAL 20121205 NDA AUTHORIZED GENERIC NDA021093 Par Pharmaceutical Inc. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 16; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49884-663_106159ae-4ee6-4dc8-bfc5-87e1f6b5531d 49884-663 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil-Hydrochlorothiazide Candesartan Cilexetil and Hydrochlorothiazide TABLET ORAL 20121205 NDA AUTHORIZED GENERIC NDA021093 Par Pharmaceutical Inc. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49884-664_106159ae-4ee6-4dc8-bfc5-87e1f6b5531d 49884-664 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil-Hydrochlorothiazide Candesartan Cilexetil Hydrochlorothiazide TABLET ORAL 20121205 NDA AUTHORIZED GENERIC NDA021093 Par Pharmaceutical Inc. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49884-665_96d09a9b-5017-4ca5-85b2-faab5a293512 49884-665 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Par Pharmaceutical Inc. MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-666_96d09a9b-5017-4ca5-85b2-faab5a293512 49884-666 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Par Pharmaceutical Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-667_96d09a9b-5017-4ca5-85b2-faab5a293512 49884-667 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Par Pharmaceutical Inc. MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-668_96d09a9b-5017-4ca5-85b2-faab5a293512 49884-668 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Par Pharmaceutical Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-669_96d09a9b-5017-4ca5-85b2-faab5a293512 49884-669 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Par Pharmaceutical Inc. MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-670_96d09a9b-5017-4ca5-85b2-faab5a293512 49884-670 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Par Pharmaceutical Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-673_6db6af49-99a1-4903-bd12-9ea591527454 49884-673 HUMAN PRESCRIPTION DRUG Cabergoline Cabergoline TABLET ORAL 20051229 ANDA ANDA076310 Par Pharmaceutical, Inc. CABERGOLINE .5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 49884-677_be0ad7fd-6e38-496c-969c-7f4633295f20 49884-677 HUMAN PRESCRIPTION DRUG Nifedipine Extended Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20070622 ANDA ANDA077899 Par Pharmaceutical, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49884-678_be0ad7fd-6e38-496c-969c-7f4633295f20 49884-678 HUMAN PRESCRIPTION DRUG Nifedipine Extended Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20070622 ANDA ANDA077899 Par Pharmaceutical, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49884-679_0fffb6c5-dfc5-4d13-bc1f-d4a35f3f66fe 49884-679 HUMAN PRESCRIPTION DRUG Nifedipine Extended Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20120529 ANDA ANDA077899 Par Pharmaceutical, Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49884-685_b88dff33-8cc6-46b9-a22c-3d325fe2ba41 49884-685 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19851017 ANDA ANDA070581 Par Pharmaceutical Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 49884-701_e2d6d6cb-7a31-45f9-a994-8e2f920f5bdb 49884-701 HUMAN PRESCRIPTION DRUG Clomiphene Citrate Clomiphene Citrate TABLET ORAL 19990830 ANDA ANDA075528 Par Pharmaceutical Inc CLOMIPHENE CITRATE 50 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 49884-724_4883e823-e38e-46e6-b257-e861dbed0442 49884-724 HUMAN PRESCRIPTION DRUG Hydroxyurea Hydroxyurea CAPSULE ORAL 19990224 ANDA ANDA075340 Par Pharmaceutical, Inc. HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] 49884-725_9da1d370-4050-45ce-8cb4-3d517c72474b 49884-725 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20120423 ANDA ANDA075467 Par Pharmaceutical Inc. BUSPIRONE HYDROCHLORIDE 7.5 mg/1 49884-726_24fcbfc8-ad92-4bb3-8ee4-606ecbee1ff0 49884-726 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20001201 ANDA ANDA065055 Par Pharmaceutical Inc. DOXYCYCLINE 50 mg/1 49884-727_24fcbfc8-ad92-4bb3-8ee4-606ecbee1ff0 49884-727 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20001201 ANDA ANDA065055 Par Pharmaceutical Inc. DOXYCYCLINE 100 mg/1 49884-734_1d46e4ae-6bb8-4a1a-836d-ac563f7de84e 49884-734 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride TABLET, FILM COATED ORAL 20100113 ANDA ANDA075755 Par Pharmaceutical, Inc FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49884-735_1d46e4ae-6bb8-4a1a-836d-ac563f7de84e 49884-735 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride TABLET, FILM COATED ORAL 20100113 ANDA ANDA075755 Par Pharmaceutical, Inc FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49884-745_15166897-a5ff-41a5-8e74-68b86efb2b60 49884-745 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130923 ANDA ANDA076159 Par Pharmaceutical, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49884-746_15166897-a5ff-41a5-8e74-68b86efb2b60 49884-746 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130923 ANDA ANDA076159 Par Pharmaceutical, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49884-753_27c5298a-02c6-4719-adc3-b17bbffe3f5f 49884-753 HUMAN PRESCRIPTION DRUG Flutamide Flutamide CAPSULE ORAL 20010918 ANDA ANDA075298 Par Pharmaceutical Inc. FLUTAMIDE 125 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 49884-761_d0358673-e6f2-42e2-87cb-73bfcb52c4f6 49884-761 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20070820 ANDA ANDA077062 Par Pharmaceutical Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-762_d0358673-e6f2-42e2-87cb-73bfcb52c4f6 49884-762 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20070820 ANDA ANDA077062 Par Pharmaceutical Inc. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-763_d0358673-e6f2-42e2-87cb-73bfcb52c4f6 49884-763 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20070820 ANDA ANDA077062 Par Pharmaceutical Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-764_d0358673-e6f2-42e2-87cb-73bfcb52c4f6 49884-764 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20070820 ANDA ANDA077062 Par Pharmaceutical Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-771_db739150-0d25-4068-80e8-4bd6636caee3 49884-771 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20000526 ANDA ANDA040357 Par Pharmaceutical, Inc. ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 49884-821_d8e23820-5e99-48f6-b27c-fac29030ce91 49884-821 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20091113 ANDA ANDA078783 Par Pharmaceutical Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 49884-822_d8e23820-5e99-48f6-b27c-fac29030ce91 49884-822 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20091113 ANDA ANDA078783 Par Pharmaceutical Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 49884-823_d8e23820-5e99-48f6-b27c-fac29030ce91 49884-823 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20110921 ANDA ANDA078783 Par Pharmaceutical Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 49884-829_2268b074-1ba9-42ff-b496-8913ef8cd21c 49884-829 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Par Pharmaceutical, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49884-830_2268b074-1ba9-42ff-b496-8913ef8cd21c 49884-830 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Par Pharmaceutical, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49884-831_2268b074-1ba9-42ff-b496-8913ef8cd21c 49884-831 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Par Pharmaceutical, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49884-832_2268b074-1ba9-42ff-b496-8913ef8cd21c 49884-832 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991224 ANDA ANDA074984 Par Pharmaceutical, Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49884-833_4598407c-11cc-4f04-8acb-723f97aa16b8 49884-833 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20121109 NDA NDA020616 Par Pharmaceutical Inc. MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-834_4598407c-11cc-4f04-8acb-723f97aa16b8 49884-834 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20121109 NDA NDA020616 Par Pharmaceutical Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-835_4598407c-11cc-4f04-8acb-723f97aa16b8 49884-835 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20121109 NDA NDA020616 Par Pharmaceutical Inc. MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-836_4598407c-11cc-4f04-8acb-723f97aa16b8 49884-836 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20121109 NDA NDA020616 Par Pharmaceutical Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-837_4598407c-11cc-4f04-8acb-723f97aa16b8 49884-837 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20121109 NDA NDA020616 Par Pharmaceutical Inc. MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-838_4598407c-11cc-4f04-8acb-723f97aa16b8 49884-838 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20121109 NDA NDA020616 Par Pharmaceutical Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49884-867_f94ee242-3e2f-479f-851f-305d93b82737 49884-867 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20080627 ANDA ANDA078292 Par Pharmaceutical Inc. DRONABINOL 2.5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 49884-868_f94ee242-3e2f-479f-851f-305d93b82737 49884-868 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20080627 ANDA ANDA078292 Par Pharmaceutical Inc. DRONABINOL 5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 49884-869_f94ee242-3e2f-479f-851f-305d93b82737 49884-869 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20080627 ANDA ANDA078292 Par Pharmaceutical Inc. DRONABINOL 10 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 49884-872_f3889812-4337-4f3e-9881-fca03ede4bc6 49884-872 HUMAN PRESCRIPTION DRUG FLUOXETINE fluoxetine hydrochloride CAPSULE ORAL 20081208 ANDA ANDA076922 Par Pharmaceutical Companies, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49884-902_f0934e7c-4d75-456b-acc9-a731a9ac7f15 49884-902 HUMAN PRESCRIPTION DRUG Mafenide acetate Mafenide acetate POWDER, FOR SOLUTION TOPICAL 20130212 ANDA ANDA201511 Par Pharmaceutical Companies, Inc. MAFENIDE ACETATE 50 g/1 Methylated Sulfonamide Antibacterial [EPC],Methylated Sulfonamides [Chemical/Ingredient] 49884-907_a6a44a3a-a940-4739-8310-b5d5a5ea5b34 49884-907 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20010725 ANDA ANDA075671 Par Pharmaceutical, Inc. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 49884-922_27784fde-c060-4c3d-b93a-3262265bfd22 49884-922 HUMAN PRESCRIPTION DRUG mercaptopurine mercaptopurine TABLET ORAL 20040211 ANDA ANDA040461 Par Pharmaceutical Companies, Inc. MERCAPTOPURINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 49884-929_04211c5d-2b95-4304-88fa-e89c5f6842e2 49884-929 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20110103 ANDA ANDA078381 Par Pharmaceutical Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 49884-930_04211c5d-2b95-4304-88fa-e89c5f6842e2 49884-930 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20110103 ANDA ANDA078381 Par Pharmaceutical Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 49884-931_04211c5d-2b95-4304-88fa-e89c5f6842e2 49884-931 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20110103 ANDA ANDA078381 Par Pharmaceutical Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 49884-932_04211c5d-2b95-4304-88fa-e89c5f6842e2 49884-932 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20110103 ANDA ANDA078381 Par Pharmaceutical Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 49884-936_c8b7f79b-cca5-4597-a193-516eebf887e5 49884-936 HUMAN PRESCRIPTION DRUG QUESTRAN Cholestyramine POWDER, FOR SUSPENSION ORAL 20050915 ANDA ANDA077204 Par Pharmaceutical Inc. CHOLESTYRAMINE 4 g/9g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 49884-937_c8b7f79b-cca5-4597-a193-516eebf887e5 49884-937 HUMAN PRESCRIPTION DRUG QUESTRAN Cholestyramine POWDER, FOR SUSPENSION ORAL 20050915 ANDA ANDA077203 Par Pharmaceutical Inc. CHOLESTYRAMINE 4 g/5g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 49884-946_b4e8325f-ff28-4346-a596-4d23db3a04a3 49884-946 HUMAN PRESCRIPTION DRUG Tramadol hydrochloride and acetaminophen tramadol hydrochloride and acetaminophen TABLET ORAL 20050421 ANDA ANDA076475 Par Pharmaceutical Inc. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 49884-949_ad5147c4-60e0-442f-b4fd-41d1956d7724 49884-949 HUMAN PRESCRIPTION DRUG Megace ES megesterol acetate SUSPENSION ORAL 20050702 NDA NDA021778 Par Pharmaceutical, Inc MEGESTROL ACETATE 125 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 49884-952_04211c5d-2b95-4304-88fa-e89c5f6842e2 49884-952 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20110103 ANDA ANDA078381 Par Pharmaceutical Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 49884-953_04211c5d-2b95-4304-88fa-e89c5f6842e2 49884-953 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20110103 ANDA ANDA078381 Par Pharmaceutical Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 49884-984_b1cfc64e-970b-4506-b3a0-e068bb7c7905 49884-984 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20090908 ANDA ANDA077463 Par Pharmaceutical Inc. NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 49884-985_b1cfc64e-970b-4506-b3a0-e068bb7c7905 49884-985 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20090908 ANDA ANDA077463 Par Pharmaceutical Inc. NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 49886-001_0be179e8-6b58-424d-8af2-be237a80bc84 49886-001 HUMAN OTC DRUG Migralex Dr. Mauskop Aspirin buffered with magnesium oxide TABLET, COATED ORAL 20091115 OTC MONOGRAPH NOT FINAL part343 Migralex Inc. ASPIRIN; MAGNESIUM OXIDE 500; 75 mg/1; mg/1 49889-1906_039b0db0-90f0-4f2b-aa43-80aa439c5f8a 49889-1906 HUMAN OTC DRUG Germ Crusher Hand Sanitizer Wipes Germ Crusher Hand Sanitizer Wipes CLOTH TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 GMS Industrial Supply, Inc. BENZALKONIUM CHLORIDE; BENZETHONIUM CHLORIDE .1; .1 g/970mL; g/970mL 49892-0002_aa4d0cde-7167-46ff-9af0-88a89f8a81af 49892-0002 HUMAN OTC DRUG Musco MXT Aralia quinquefolia, Epiphegus virginiana, Jacaranda caroba, Lacticum acidum, Hydrocotyle asiatica, Hydrocyanicum acidum, LIQUID ORAL 20130627 UNAPPROVED HOMEOPATHIC Sandco International, Inc CENTELLA ASIATICA; EPIFAGUS VIRGINIANA; HYDROGEN CYANIDE; JACARANDA CAROBA FLOWER; LACTIC ACID, DL-; PANAX QUINQUEFOLIUS WHOLE 100; 15; 100; 15; 15; 15 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 49893-100_f2258cda-072e-413f-8feb-07bcbd11218a 49893-100 HUMAN OTC DRUG Total Suncare Sunscreen SPF 15 AVOBENZONE, OCTISALATE, OCTINOXATE, OXYBENZONE SPRAY TOPICAL 20091125 OTC MONOGRAPH FINAL part352 Total Suncare LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 1; 2; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 49893-200_b07bf5e6-4502-438f-8ed5-a21e3f3ccbf7 49893-200 HUMAN OTC DRUG Total Suncare Sunscreen SPF 30 AVOBENZONE, OCTISALATE, OCTINOXATE, OXYBENZONE SPRAY TOPICAL 20091125 OTC MONOGRAPH FINAL part352 Total Suncare LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 5; 2; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL 49893-300_53d8c96e-f8df-4033-851c-c7cb0337d018 49893-300 HUMAN OTC DRUG Total Suncare Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE SPRAY TOPICAL 20091125 OTC MONOGRAPH FINAL part352 Total Suncare LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 10; 3; 3; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 49893-500_3ff235f5-6093-482c-a0f8-20498228e063 49893-500 HUMAN OTC DRUG Total Suncare Sunscreen SPF 70 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE SPRAY TOPICAL 20091208 OTC MONOGRAPH FINAL part352 Total Suncare LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 15; 5; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 49897-066_f798de25-446b-439c-aa74-bf8db8e9a460 49897-066 HUMAN OTC DRUG Nuvel Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20091026 OTC MONOGRAPH NOT FINAL part333 Industrias Lavin de Mexico S.A. de C.V. ALCOHOL 65 mL/100mL 49897-159_51a49850-3d62-4af7-a2d7-6d84201c9596 49897-159 HUMAN OTC DRUG Nuvel Tropic Roll-on Antiperspirant Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20091030 OTC MONOGRAPH FINAL part350 Industrias Lavin de Mexico S.A. de C.V. ALUMINUM CHLOROHYDRATE 18 mL/100mL 49897-160_68959d75-ded2-4f9f-8078-47c6167be13e 49897-160 HUMAN OTC DRUG Nuvel Softy Roll-on Antiperspirant Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20091030 OTC MONOGRAPH FINAL part350 Industrias Lavin de Mexico S.A. de C.V. ALUMINUM CHLOROHYDRATE 18 mL/100mL 49897-161_66105c19-1908-4d7c-ae4f-d3e4320f7029 49897-161 HUMAN OTC DRUG Nuvel Devotion Roll-on Antiperspirant Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20091030 OTC MONOGRAPH FINAL part350 Industrias Lavin de Mexico S.A. de C.V. ALUMINUM CHLOROHYDRATE 18 mL/100mL 49897-162_fe0ad125-c7d0-4119-b162-4acab8dd12bc 49897-162 HUMAN OTC DRUG Nuvel Instinct Roll-on Antiperspirant Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20091030 OTC MONOGRAPH FINAL part350 Industrias Lavin de Mexico S.A. de C.V. ALUMINUM CHLOROHYDRATE 18 mL/100mL 49897-273_83fedfb2-bcb6-49c1-abe0-5ebc2ae876c7 49897-273 HUMAN OTC DRUG Nuvel Tropic Antiperspirant Deodorant Stick Aluminum Chlorohydrate STICK TOPICAL 20091028 OTC MONOGRAPH FINAL part350 Industrias Lavin de Mexico S.A. de C.V. ALUMINUM CHLOROHYDRATE 20 g/100g 49897-274_b258a673-2c51-414b-854c-2247d8f5acf8 49897-274 HUMAN OTC DRUG Nuvel Softy Antiperspirant Deodorant Stick Aluminum Chlorohydrate STICK TOPICAL 20091028 OTC MONOGRAPH FINAL part350 Industrias Lavin de Mexico S.A. de C.V. ALUMINUM CHLOROHYDRATE 20 g/100g 49902-3591_64557d60-ef59-4ef5-8991-a11a9de25c07 49902-3591 HUMAN OTC DRUG NEW BRAND PERFUMES MENS ROLL ON ANTIPERSPIRANT DEODORANT ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20101213 OTC MONOGRAPH FINAL part350 BB TRADING WORLDWIDE, INC ALUMINUM CHLOROHYDRATE 25 mL/100mL 49902-3690_dabaa933-c04f-4182-8c6a-371339312093 49902-3690 HUMAN OTC DRUG CUBA ORIGINAL MENS ROLL ON ANTIPERSPIRANT DEODORANT ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100831 OTC MONOGRAPH FINAL part350 BB TRADING WORLDWIDE, INC ALUMINUM CHLOROHYDRATE 25 mL/100mL 49902-3942_b839191c-1417-487c-8761-07c324473111 49902-3942 HUMAN OTC DRUG CUBA ORIGINAL LADIES ROLL ON ANTIPERSPIRANT DEODORANT ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100831 OTC MONOGRAPH FINAL part350 BB TRADING WORLDWIDE, INC ALUMINUM CHLOROHYDRATE 25 mL/100mL 49902-5366_63dfb796-b13e-42c2-b337-4ec178f24b4b 49902-5366 HUMAN OTC DRUG NEW BRAND PERFUMES LADIES ROLL ON ANTIPERSPIRANT DEODORANT ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20101213 OTC MONOGRAPH FINAL part350 BB TRADING WORLDWIDE, INC ALUMINUM CHLOROHYDRATE 25 mL/100mL 49908-137_8feb4318-48d2-45c7-a9cb-833676de38d5 49908-137 HUMAN PRESCRIPTION DRUG Salicylic Acid Salicylic Acid LIQUID TOPICAL 20110330 UNAPPROVED DRUG OTHER Rochester Pharmaceuticals SALICYLIC ACID 260 mg/mL 49908-146_5e7960ad-8524-4b14-8b8a-903149737dd2 49908-146 HUMAN PRESCRIPTION DRUG SELENIUM SULFIDE SELENIUM SULFIDE SHAMPOO TOPICAL 20110330 UNAPPROVED DRUG OTHER Rochester Pharmaceuticals SELENIUM SULFIDE 22.5 mg/mL 49908-150_26817841-b372-4da5-a471-d82946303cfb 49908-150 HUMAN PRESCRIPTION DRUG PRAMCORT 1% HYDROCORTISONE ACETATE W/W 1% PRAMOXINE HYDROCHLORIDE W/W CREAM CREAM TOPICAL 20110330 UNAPPROVED DRUG OTHER Rochester Pharmaceuticals HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 10; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49908-167_fb914efb-3d27-4298-8a54-b5e45b235ef9 49908-167 HUMAN PRESCRIPTION DRUG FORMALDEHYDE FORMALDEHYDE LIQUID TOPICAL 20110427 UNAPPROVED DRUG OTHER Rochester Pharmaceuticals FORMALDEHYDE 100 mg/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC] 49908-173_b399ebd8-330e-4143-9314-7a8c6064b447 49908-173 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE and SULFUR Wash SODIUM SULFACETAMIDE and SULFUR CREAM TOPICAL 20110804 UNAPPROVED DRUG OTHER Rochester Pharmaceuticals SULFACETAMIDE SODIUM; SULFUR 90; 45 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 49908-237_2708b770-913f-4f6b-881b-98994081e16f 49908-237 HUMAN PRESCRIPTION DRUG Salicylic Acid Salicylic Acid LIQUID TOPICAL 20111107 UNAPPROVED DRUG OTHER Rochester Pharmaceuticals SALICYLIC ACID 275 mg/mL 49908-273_454a6f6d-d0d6-4ae6-a64b-32d710c202a3 49908-273 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE and SULFUR Topical Suspension SODIUM SULFACETAMIDE and SULFUR SUSPENSION TOPICAL 20131104 UNAPPROVED DRUG OTHER Rochester Pharmaceuticals SULFACETAMIDE SODIUM; SULFUR 80; 40 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 49909-005_f7d3bcc2-68dd-4acf-b885-0dc784e9bb21 49909-005 HUMAN PRESCRIPTION DRUG Fluoxetine HCl Fluoxetine HCl TABLET, FILM COATED ORAL 20111114 NDA NDA202133 Edgemont Pharmaceuticals, LLC FLUOXETINE HYDROCHLORIDE 60 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49909-010_71f04c62-ce80-4a49-9e13-6a91f16c00c9 49909-010 HUMAN PRESCRIPTION DRUG Forfivo XL bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121001 NDA NDA022497 Edgemont Pharmaceuticals, LLC BUPROPION HYDROCHLORIDE 450 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49911-884_d5ee882b-fa9c-4657-9488-fa81bee09dfc 49911-884 HUMAN OTC DRUG Plum Smooth Plumb Numb Gelee Lidocaine GEL TOPICAL 20120329 OTC MONOGRAPH NOT FINAL part348 Universal Companies, Inc. LIDOCAINE 4 g/100g 49922-001_f2b8ef51-43a1-4f9a-a810-30ff727fdfa2 49922-001 HUMAN OTC DRUG Secure Instant Foaming Hand Sanitizer Hand Sanitizer LIQUID TOPICAL 20091005 OTC MONOGRAPH NOT FINAL part333 American Cleaning Solutions BENZALKONIUM CHLORIDE .1 mL/100mL 49922-002_6d36a498-239e-4f67-b44f-c21e31de900b 49922-002 HUMAN OTC DRUG Secure Instant Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333A American Cleaning Solutions BENZALKONIUM CHLORIDE .1 mL/100mL 49924-1231_dd3a1acb-ee7e-4acb-8a22-108f513aa57d 49924-1231 HUMAN OTC DRUG On Guard Hand Sanitizing Wipe Alcohol CLOTH TOPICAL 20091101 OTC MONOGRAPH FINAL part358 do Terra ALCOHOL 1 ug/mL 49930-001_e7c36f95-b15d-4bef-89c9-cf87eaf1f6c3 49930-001 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20141117 ANDA ANDA200981 Rubicon Research Private Limited METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49930-002_e7c36f95-b15d-4bef-89c9-cf87eaf1f6c3 49930-002 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20141117 ANDA ANDA200981 Rubicon Research Private Limited METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49930-003_e7c36f95-b15d-4bef-89c9-cf87eaf1f6c3 49930-003 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20141117 ANDA ANDA200981 Rubicon Research Private Limited METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49936-1303_9a2ac669-27ef-4908-84ee-c5ed10fa22c9 49936-1303 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091117 UNAPPROVED MEDICAL GAS Orsini Home Medical Equipment Inc. OXYGEN 1 L/L 49938-101_86f0143f-045c-4667-bf49-ccd933978428 49938-101 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20080815 ANDA ANDA086842 Jacobus Pharmaceutical Company, Inc. DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] 49938-102_86f0143f-045c-4667-bf49-ccd933978428 49938-102 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20080815 ANDA ANDA086841 Jacobus Pharmaceutical Company, Inc. DAPSONE 25 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] 49938-107_10cc23df-b73d-4422-ad00-2f75ffc3cfbd 49938-107 HUMAN PRESCRIPTION DRUG Paser AMINOSALICYLIC ACID GRANULE, DELAYED RELEASE ORAL 19950215 ANDA ANDA074346 Jacobus Pharmaceutical Company, Inc. AMINOSALICYLIC ACID 4 g/1 49939-201_bd5cc995-1925-4260-8999-6ea8cac811f7 49939-201 HUMAN OTC DRUG NeutraCaine Benzocaine hydrochloride POWDER, FOR SOLUTION ORAL 20140307 OTC MONOGRAPH NOT FINAL part356 Invado Pharmaceuticals, LLC BENZOCAINE HYDROCHLORIDE 90 mg/1 49944-001_eae13135-3dbc-48f0-86ff-2dee3bd51bdf 49944-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS I.D.M. Medical Supply Company Inc. OXYGEN 99 L/100L 49944-010_eae13135-3dbc-48f0-86ff-2dee3bd51bdf 49944-010 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS I.D.M. Medical Supply Company Inc. OXYGEN 99 L/100L 49947-001_4f4cbaa4-fdea-4105-a702-9b239e454951 49947-001 HUMAN OTC DRUG Hush Anesthetic Lidocaine SPRAY TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part348 HUSH Anesthetic LIDOCAINE 40 mg/g 49947-002_2c28e5a6-6651-4978-92ac-5b24d8daeff0 49947-002 HUMAN OTC DRUG Hush Anesthetic Lidocaine GEL TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part348 HUSH Anesthetic LIDOCAINE 40 mg/g 49947-003_202ea613-ef09-401a-8b5c-5027a09d2190 49947-003 HUMAN OTC DRUG Hush Anesthetic Lidocaine, Benzalkonium Chloride SOAP TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part348 HUSH Anesthetic BENZALKONIUM CHLORIDE; LIDOCAINE 1.3; 40 mg/g; mg/g 49952-001_9d448bee-41f5-4baa-a356-d0f457a73f58 49952-001 HUMAN OTC DRUG Zhenweilong Huoluo You External Analgesic Camphor Menthol Methyl Salicylate OIL TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part348 Uncle Bill Trading USA Inc. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 10; 15; 30 g/100mL; g/100mL; g/100mL 49952-002_8e73e7ef-56a4-469f-9ace-b89c926745fa 49952-002 HUMAN OTC DRUG Jun Wai Lung Medicine Pain relieving Camphor Menthol Methyl Salicylate OIL TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part348 Uncle Bill Trading USA Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 10; 15; 33 g/100mL; g/100mL; g/100mL 49952-003_ebe8ddad-525c-43b4-922d-f3ed97bd0b5d 49952-003 HUMAN OTC DRUG Zihuadick Pain relieving Camphor Menthol Methyl Salicylate LIQUID TOPICAL 20131230 OTC MONOGRAPH NOT FINAL part348 Uncle Bill Trading USA Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3; 10; 10 g/100mL; g/100mL; g/100mL 49952-004_d831d537-3a36-4410-9c18-e980e1f36e45 49952-004 HUMAN OTC DRUG ZIHUA EMBROCATION Cooling Pain Relief Camphor Menthol Methyl Salicylate OIL TOPICAL 20140415 OTC MONOGRAPH NOT FINAL part348 Uncle Bill Trading USA Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 11; 15; 15 g/100mL; g/100mL; g/100mL 49953-1893_aeb97fea-9573-4a32-a452-9e4d704c3c3f 49953-1893 HUMAN OTC DRUG Povidone Iodine Povidone Iodine SWAB TOPICAL 20100702 OTC MONOGRAPH FINAL part333C Dalian Rongbang Medical Healthy Devices Co POVIDONE-IODINE 10 mL/100mL 49953-1894_e2f13ed7-395b-4bb6-aa3d-2516921a107c 49953-1894 HUMAN OTC DRUG Lemon Glycerin Glycerine SWAB TOPICAL 20100702 OTC MONOGRAPH FINAL part349 Dalian Rongbang Medical Healthy Devices Co GLYCERIN .43 mL/10mL 49953-2801_60fe49cc-22f2-45a5-84ed-4af9e1701091 49953-2801 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20100702 OTC MONOGRAPH FINAL part344 Dalian Rongbang Medical Healthy Devices ISOPROPYL ALCOHOL 7 mL/10mL 49953-2801_a20f14fc-ad1d-4b3d-9927-49bbe8fc9f7b 49953-2801 HUMAN OTC DRUG Alcohol Isopropyl Alcohol SWAB TOPICAL 20100702 OTC MONOGRAPH FINAL part344 Dalian Rongbang Medical Helathy Devices Co ISOPROPYL ALCOHOL 70 mL/100mL 49953-2805_39e6ca2b-0fb9-42ae-91f3-b7e1b71c8687 49953-2805 HUMAN OTC DRUG Povidone Iodine Povidone Iodine SWAB TOPICAL 20100702 OTC MONOGRAPH FINAL part333C Dalian Rongbang Medical Healthy Devices Co POVIDONE-IODINE 1 mL/10mL 49955-100_1f8fe83c-fcaf-489e-b0b8-01817ee2a81a 49955-100 HUMAN OTC DRUG Azuro ALCOHOL GEL TOPICAL 20091118 OTC MONOGRAPH NOT FINAL part333 Noveko Inc ALCOHOL .7 L/L 49955-600_0c3d075b-8b9a-4c6d-a431-7eff637819fe 49955-600 HUMAN OTC DRUG Microban ALCOHOL GEL TOPICAL 20091118 OTC MONOGRAPH NOT FINAL part333 Noveko Inc ALCOHOL .7 L/L 49955-610_48e0ca8e-637a-4cc7-bd2a-a4ea7061becc 49955-610 HUMAN OTC DRUG Microban Unscented ALCOHOL GEL TOPICAL 20091118 OTC MONOGRAPH NOT FINAL part333 Noveko Inc ALCOHOL .7 L/L 49955-680_542a1fa4-24f2-4ce6-96b2-58095b899d90 49955-680 HUMAN OTC DRUG Microban 80 ALCOHOL GEL TOPICAL 20091118 OTC MONOGRAPH NOT FINAL part333 Noveko Inc ALCOHOL .8 L/L 49959-1111_8b28802d-c750-4607-a01c-4ebaa25e115f 49959-1111 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol GEL TOPICAL 20091130 OTC MONOGRAPH FINAL part333 Graphic Controls ALCOHOL .6 g/mL 49963-118_85b201f0-1f3b-4401-ad6d-b76c270ff883 49963-118 HUMAN OTC DRUG Bronkids Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide LIQUID ORAL 20070403 OTC MONOGRAPH FINAL part341 Portal Pharmaceutical CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE .6; 2.75; 1.5 mg/mL; mg/mL; mg/mL 49963-210_a2c5b8a8-e7ca-4e6c-9432-538ca8294077 49963-210 HUMAN OTC DRUG Bronkids Chlorpheniramine/Dextromethorphan/Phenylephrine LIQUID ORAL 20090801 OTC MONOGRAPH FINAL part341 Portal Pharmaceutical CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 15; 10 mg/5mL; mg/5mL; mg/5mL 49963-381_148d8c18-9501-4127-9357-24372c7a84c3 49963-381 HUMAN OTC DRUG Brontuss SF-NR Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20111222 OTC MONOGRAPH FINAL part341 Portal Pharmaceutical DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 300; 10 mg/5mL; mg/5mL; mg/5mL 49963-532_c386c458-4510-437b-beb7-5d5ec607a732 49963-532 HUMAN OTC DRUG Bronkids Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20111010 OTC MONOGRAPH FINAL part341 Portal Pharmaceutical CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 10; 10 mg/5mL; mg/5mL; mg/5mL 49963-630_11108f5d-d9ea-498e-ba87-a6eff07dfa7f 49963-630 HUMAN OTC DRUG Clophed Chlophedianol Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20100528 OTC MONOGRAPH FINAL part341 Portal Pharmaceutical CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 12.5; 100; 5 mg/5mL; mg/5mL; mg/5mL 49963-813_e1f6b972-4786-4c51-aaf8-181d6da0f5e8 49963-813 HUMAN OTC DRUG Brontuss SF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20100316 OTC MONOGRAPH FINAL part341 Portal Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 300; 10 mg/5mL; mg/5mL; mg/5mL 49963-913_5012801b-7bba-48d0-8636-68300642c6bd 49963-913 HUMAN OTC DRUG Brontuss DX Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20091124 OTC MONOGRAPH FINAL part341 Portal Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/5mL; mg/5mL; mg/5mL 49967-003_35da0fc7-528f-43f7-a88f-ba56ccae536c 49967-003 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 60 Melt In Sunscreen Milk Broad Spectrum SPF 60 Face and Body Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 107.2; 32.1; 60; 38.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-004_fcdcfc05-84c6-4726-9485-a3d603d81bb5 49967-004 HUMAN OTC DRUG Vichy Laboratoires Normaderm Purifying Pore Tightening Toner Salicylic Acid LIQUID TOPICAL 20120201 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 5 mg/mL 49967-005_bb73de7c-72f5-4211-95f5-472e6bc50810 49967-005 HUMAN OTC DRUG Vichy Laboratoires Normaderm Daily Deep Cleansing Salicylic Acid GEL TOPICAL 20120201 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 5 mg/mL 49967-006_29102500-f316-49df-8b42-9b556a233f37 49967-006 HUMAN OTC DRUG Maybelline New York Instant Age Rewind Eraser Treatment Makeup SPF 18 Octinoxate LIQUID TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 1.5 mL/20mL 49967-007_f07b2ab5-096f-453e-89df-fdcd26f81054 49967-007 HUMAN OTC DRUG Maybelline New York Instant Age Rewind Eraser Treatment Makeup Broad Spectrum SPF 18 Sunscreen Octinoxate LOTION TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 75 mg/mL 49967-017_5d9241ec-2bf2-4ad2-86db-3947856a2b95 49967-017 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios SX Daily Moisturizing Sunscreen Broad Spectrum SPF 15 Avobenzone, Ecamsule and Octocrylene CREAM TOPICAL 20140729 NDA NDA021502 L'Oreal USA Products Inc AVOBENZONE; ECAMSULE; OCTOCRYLENE 20; 20; 100 mg/g; mg/g; mg/g 49967-018_1a99aa9a-8a01-4d94-a26b-bf0bbe37492b 49967-018 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Body Broad Spectrum SPF 50 Ultra Light Sunscreen Titanium Dioxide LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 110 mg/mL 49967-019_433ec4ec-284b-41ea-bc61-b8ab90874289 49967-019 HUMAN OTC DRUG Dermablend Quick Fix Concealer Titanium Dioxide CREAM TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 30 mg/g 49967-021_72cc2ecb-2226-4576-9bf7-d14edec66b53 49967-021 HUMAN OTC DRUG Yves Saint Laurent Forever Youth Liberator Sunscreen Broad Spectrum SPF 15 Antiwrinkle Lift Plump Radiance Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 21; 35; 49 mg/mL; mg/mL; mg/mL 49967-023_0cdcaaf2-367c-4b2a-ab5b-85d4afef039b 49967-023 HUMAN OTC DRUG La Roche Posay Laboratorie Dermatologique Effaclar Medicated Cleanser Salicylic Acid GEL TOPICAL 20140801 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 20 mg/mL 49967-024_91257f65-8226-4407-ad72-eead08fdfcaf 49967-024 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Effaclar Clarifying Salicylic Acid SOLUTION TOPICAL 20140801 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 5 mg/mL 49967-027_6de9482c-ce7e-4a72-a8f4-b783c053fede 49967-027 HUMAN OTC DRUG Garnier UltraLift Transformer AntiAge Skin Corrector Broad Spectrum SPF 20 Sunscreen Octisalate and Octocrylene LOTION TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTISALATE; OCTOCRYLENE 49; 44 mg/mL; mg/mL 49967-028_bea38b05-c62d-4979-a94f-743b8c743985 49967-028 HUMAN OTC DRUG Garnier Nutritioniste Skin Renew Radiance Moisture Lotion SPF 15 Ensulizole Octinoxate LOTION TOPICAL 20090801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc ENSULIZOLE; OCTINOXATE 1.125; 5.62 mL/75mL; mL/75mL 49967-029_48907ba7-385c-4d15-9636-f7320949ebf4 49967-029 HUMAN OTC DRUG La Roche-Posay Laboratoire Pharmaceutique Anthelios 60 Melt-In Sunscreen Lotion SPF 60 Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20090801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 7.5; 2.5; 2.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL 49967-030_5a0e8828-8f6b-4fe4-8a0a-a848627408a8 49967-030 HUMAN OTC DRUG SkinCeuticals Daily Sun Defense Broad Spectrum SPF 20 Sunscreen Octinoate and Zinc Oxide CREAM TOPICAL 20060607 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; ZINC OXIDE 50; 50 mg/mL; mg/mL 49967-031_a62072bd-3856-4c2e-8a7f-aefc9d947785 49967-031 HUMAN OTC DRUG LOreal Paris Advanced Suncare Quick Dry Sheer Finish 30 Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 29.6; 87.8; 48.8; 59.2 mg/g; mg/g; mg/g; mg/g 49967-032_6316ef1b-7408-4316-93b9-f38f12e96193 49967-032 HUMAN OTC DRUG La Roche-Posay Laboratoire Pharmaceutique Anthelios 60 Melt-In Sunscreen Milk SPF 60 Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20090801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.5; 22.5; 7.5; 7.5; 9 mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL 49967-033_2cd80eee-44a7-48e5-9fe3-3c5c8548056b 49967-033 HUMAN OTC DRUG Vichy Laboratoires Normaderm Daily Pore Unclogging Scrub Salicylic Acid GEL TOPICAL 20120201 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 5 mg/mL 49967-035_4dc1042d-9aa4-4c0c-a95e-7fae183c3734 49967-035 HUMAN OTC DRUG Garnier Clean Blackhead Eliminating Scrub Salicylic Acid GEL TOPICAL 20140101 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 20 mg/mL 49967-041_7bd2ad4c-31d5-43ab-b9cc-be99b7a66030 49967-041 HUMAN OTC DRUG Vichy Laboratoires Aqualia Thermal Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 60; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL 49967-045_e645ace1-d77e-4ca3-8b81-31579e4ef959 49967-045 HUMAN OTC DRUG Maybelline New York Instant Age Rewind Radiant Firming Makeup Broad Spectrum SPF 18 Sunscreen Octinoxate LOTION TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 45 mg/mL 49967-050_a3eef931-cd87-4ce6-b4ee-c94417491638 49967-050 HUMAN OTC DRUG SkinCeuticals Physical Eye UV Defense Sunscreen Titanium dioxide and Zinc oxide LOTION TOPICAL 20140418 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE; ZINC OXIDE 90; 40 mg/mL; mg/mL 49967-052_78426dac-7486-4dc1-b88a-15e2e6273438 49967-052 HUMAN OTC DRUG Matrix Biolage ScalpSync Antidandruff Pyrithione Zinc SHAMPOO TOPICAL 20140501 OTC MONOGRAPH FINAL part358H L'Oreal USA Products Inc PYRITHIONE ZINC 10 mg/mL 49967-060_ffcb0095-2129-4cc0-b7a4-ca74467e7a05 49967-060 HUMAN OTC DRUG Dermablend Smooth Indulgence Concealer Titanium Dioxide LOTION TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 61 mg/mL 49967-065_c64699b8-6bbe-408a-9862-d5626c1cc943 49967-065 HUMAN OTC DRUG Yves Saint Laurent Le Teint Touche Eclat Sunscreen Illuminating Foundation SPF 19 Octinoxate LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 2.1 mL/30mL 49967-066_d764204d-8675-4485-b40f-89bd572a42dd 49967-066 HUMAN OTC DRUG SkinCeuticals Sport UV Defense Sunscreen Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 150; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL 49967-067_d4d5d821-34da-4d26-a2fc-3f2bc82700a3 49967-067 HUMAN OTC DRUG Dermablend Smooth Indulgence Foundation Titanium Dioxide LOTION TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 61 mg/mL 49967-075_f40cb41f-058f-4c7c-b064-29183cf749e0 49967-075 HUMAN OTC DRUG La Roche Posay Laboratoire DermatologiqueEffaclar Duo Effaclar Duo Benzoyl peroxide LOTION TOPICAL 20120701 OTC MONOGRAPH FINAL part333D L'OREAL USA, INC. BENZOYL PEROXIDE 2.2 mg/40mL 49967-077_b3e55b25-2588-4d8d-9f55-7a0e7e927e5f 49967-077 HUMAN OTC DRUG SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 50 mg/mL; mg/mL 49967-078_60a44f60-0897-4f90-b6a5-d4cddc570769 49967-078 HUMAN OTC DRUG Kiehls Since 1851 Activated Sun Protector For Body Broad Spectrum SPF 50 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-079_ca8c23a2-9705-4157-ac83-8bdd00103302 49967-079 HUMAN OTC DRUG LOreal Paris Youth Code Day Avobenzone Homosalate Octisalate Octocrylene CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.35; 2.25; 2.25; 3.15 g/45g; g/45g; g/45g; g/45g 49967-080_13bd7c1d-8fbf-4d6f-bc18-831b010edc78 49967-080 HUMAN OTC DRUG Maybelline New York Dream Wonder Fluid Touch Foundation Broad Spectrum SPF 20 Sunscreen Octinoxate LOTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL 49967-082_12634841-99c4-4fa5-a4d1-381e621e8231 49967-082 HUMAN OTC DRUG LOreal Paris Revitalift Triple Power Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL 49967-084_f2e6556e-b1d9-4482-80f7-1b4347d46a90 49967-084 HUMAN OTC DRUG La Roche Posay Anthelios 60 Ultralight Sunscreen Avobenzone Homosalate Octisalate Octocrylene Oxybenzone SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.29; 21.45; 7.17; 10.01; 8.58 g/143g; g/143g; g/143g; g/143g; g/143g 49967-085_f8f3e929-0c4f-47ec-8805-a5e9963fcf6e 49967-085 HUMAN OTC DRUG La Roche Posay Anthelios 30 Ultralight Sunscreen Avobenzone Homosalate Octisalate Octocrylene Oxybenzone SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.29; 17.16; 7.17; 10.01; 8.58 g/143g; g/143g; g/143g; g/143g; g/143g 49967-088_daf8a5b0-c5d5-41f2-9fcf-989a55079428 49967-088 HUMAN OTC DRUG Vichy Laboratoire Capital Soleil SPF 60 Soft Sheer Sunscreen Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20110421 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.5; 22.5; 7.5; 7.5; 9 mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL 49967-089_a88609bc-0d95-4be5-b8a4-7b46d50eec6c 49967-089 HUMAN OTC DRUG Vichy Laboratoire Capital Soleil SPF 30 Soft Sheer Sunscreen Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20110421 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.5; 7.5; 7.5; 10.5; 9 mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL 49967-090_f36d4647-9237-49b5-b3f8-be8cb9f110a5 49967-090 HUMAN OTC DRUG La RochePosay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Sunscreen Titanium dioxide LOTION TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 5.5 mL/50mL 49967-092_9bcbe8cc-414b-430d-a2b4-aa4eba12a30d 49967-092 HUMAN OTC DRUG Garnier UltraLift SPF 30 Deep Wrinkle Day Avobenzone Homosalate Octisalate Octocrylene CREAM TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.44; .96; 2.4; 3.36 mL/48mL; mL/48mL; mL/48mL; mL/48mL 49967-094_2a612854-ed7d-4efc-8c1b-39b1bc84397e 49967-094 HUMAN OTC DRUG LOreal Paris Skin Expertise Age Perfect Broad Spectrum SPF 20 Sunscreen BB Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL 49967-095_d3d5987d-1f4d-4ee5-b142-5cfa0310d21d 49967-095 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 50 Daily Antiaging Primer with Sunscreen Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20120405 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.2; 4; 2; 2; 2.4 mL/40mL; mL/40mL; mL/40mL; mL/40mL; mL/40mL 49967-097_ffe50d11-2709-4931-a9f5-08b70aaca549 49967-097 HUMAN OTC DRUG SkinCeuticals Blemish Plus Age Defense Acne Treatment Salicylic Acid LOTION TOPICAL 20050801 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 15 mg/mL 49967-105_7c568f28-5573-4f10-b4a0-97444fe9b979 49967-105 HUMAN OTC DRUG Dermablend Professional SkinPerfector Redness Reducing Primer Sunscreen Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 20; 33; 46 mg/mL; mg/mL; mg/mL 49967-106_7a016f56-fbf2-4e5e-9056-2de1be5baa98 49967-106 HUMAN OTC DRUG Dermablend Professional SkinPerfector Blemish and Oil Clearing Primer Salicylic acid LOTION TOPICAL 20121001 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 5 mg/mL 49967-120_62378718-2f7f-4782-8079-d74dc1d2b4c6 49967-120 HUMAN OTC DRUG Giorgio Armani Regenessence High Lift SPF 15 Avobenzone Octisalate Octocrylene CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 2.5; 3.5 mL/50mL; mL/50mL; mL/50mL 49967-121_3e909d27-23c6-4e14-8cbf-ef8fb785e7d9 49967-121 HUMAN OTC DRUG Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 30 Sunscreen for Body Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone AEROSOL, SPRAY TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 70; 60 mg/g; mg/g; mg/g; mg/g; mg/g 49967-125_63d9bb35-7730-4a9c-85aa-cd4ae07f7752 49967-125 HUMAN OTC DRUG Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 50 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone AEROSOL, SPRAY TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 70; 60 mg/g; mg/g; mg/g; mg/g; mg/g 49967-126_cdf02000-9c90-4bcb-a3c6-36f3ef6a14d2 49967-126 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense Moisturizer Broad Spectrum SPF 20 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 47; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL 49967-128_7df19ac5-9984-4d3d-a759-08e11e4ef800 49967-128 HUMAN OTC DRUG Maybelline New York Pure Stay Powder Foundation Broad Spectrum SPF 15 Sunscreen Octinoxate POWDER TOPICAL 20020801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 40 mg/g 49967-129_52e9c44a-4c1b-4d9d-9c43-22164352a4e9 49967-129 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Ultra Light Fluid Sunscreen Broad Spectrum SPF 60 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 107.2; 32.1; 60; 38.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-130_66e7a421-fde3-4b61-887e-eb04187a51db 49967-130 HUMAN OTC DRUG LOreal Paris Skin Expertise Collagen Moisture Filler Daily Moisturizer Day Lotion SPF15 Ensulizole Octinoxate LOTION TOPICAL 20090601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc ENSULIZOLE; OCTINOXATE 1.08; 4.5 mL/60mL; mL/60mL 49967-134_017ab6a5-4992-4aa3-b890-39709de0bff5 49967-134 HUMAN OTC DRUG Garnier Skin Renew Miracle Skin Perfector AntiAging BB Broad Spectrum SPF 15 Sunscreen Octinoxate and Titanium Dioxide CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 30; 36 mg/mL; mg/mL 49967-135_be62eccc-97e2-497d-be2b-d9a2a4f7d632 49967-135 HUMAN OTC DRUG Yves Saint Laurent Forever Youth Liberator Broad Spectrum SPF 15 Sunscreen Fluid Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 21; 35; 49 mg/mL; mg/mL; mg/mL 49967-137_2bd066d0-2e0d-4005-9703-1af2fff00bd7 49967-137 HUMAN OTC DRUG Lancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing Treatment Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 20; 50; 100 mg/g; mg/g; mg/g 49967-152_dc26e8a3-63ff-447a-b54e-b84e8fdddf12 49967-152 HUMAN OTC DRUG Giorgio Armani Designer Shaping Foundation Broad Spectrum SPF 20 Sunscreen Octinoxate and Titanium dioxide CREAM TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 40; 20 mg/mL; mg/mL 49967-159_46c143f3-7155-40d7-a145-62f7c4c3f0b6 49967-159 HUMAN OTC DRUG LOreal Paris Dermo Expertise SPF 15 Active Daily Moisture Ensulizole Octinoxate LOTION TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc ENSULIZOLE; OCTINOXATE 2.36; 8.26 mL/118mL; mL/118mL 49967-166_bf591a3e-c0f7-4c8d-a67c-956089c1602c 49967-166 HUMAN OTC DRUG Lancome Paris Absolue Precious Cells Sunscreen Repairing and Recovering Day Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20090801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/g; mg/g; mg/g 49967-170_1715cf6e-2e76-4413-b8dc-f16adb118f42 49967-170 HUMAN OTC DRUG LOreal Paris Skin Expertise Age Perfect For Mature Skin Anti-Sagging Anti-Age Spot Hydrating Moisturizer Day Cream SPF 15 Ensulizole Octinoxate CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc ENSULIZOLE; OCTINOXATE 1.19; 5.25 g/70g; g/70g 49967-171_eee717ef-ab0a-42dc-a1a2-839cb53dfd16 49967-171 HUMAN OTC DRUG Garnier Skin Renew Miracle Skin Perfector Octinoxate CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 3 mL/75mL 49967-182_30e6b0ec-f0d6-4807-853b-75fb696ccf88 49967-182 HUMAN OTC DRUG Giorgio Armani Designer Lift Smoothing Firming Foundation Broad Spectrum SPF 20 Sunscreen Octinoxate and Titanium dioxide LOTION TOPICAL 20060801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 75; 19 mg/mL; mg/mL 49967-184_7804ef21-f6a2-4aa3-b8c9-f3649ae3a68b 49967-184 HUMAN OTC DRUG Lancome Paris Bienfait MultiVital Broad Spectrum SPF 30 Sunscreen 24 Hour Moisturization Antioxidant and Vitamin Enriched Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20051001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL 49967-187_3f7facf8-6c91-459f-a24d-3c58aee3c3e7 49967-187 HUMAN OTC DRUG Lancome Paris Bienfait MultiVital Eye SPF 28 Sunscreen 24 Hour Moisturization Antioxidant and Vitamin Enriched Octinoxate and Titanium Dioxide CREAM TOPICAL 20081101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 75; 50 mg/g; mg/g 49967-195_400a7251-f893-491e-b5b9-812a6572821d 49967-195 HUMAN OTC DRUG Lancome Paris Absolue Premium Bx Absolute Replenishing SPF 15 Avobenzone Octisalate Octocrylene CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 5; 2.5; 4 g/50g; g/50g; g/50g 49967-206_11496439-4310-44ae-9dff-b47eb0ea5eed 49967-206 HUMAN OTC DRUG Giorgio Armani Regenessence High Lift Muti Firming Rejuvenating Broad Spectrum SPF 15 Sunscreen Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL 49967-208_feb4a445-9e91-4c58-9b39-edc0674ef26e 49967-208 HUMAN OTC DRUG Vichy Laboratoires Capital Soleil 30 Broad Spectrum SPF 30 Sunscreen Luxurious Protective Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone OIL TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 70; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-213_041d7131-5c9f-4290-8928-604994308822 49967-213 HUMAN OTC DRUG Giorgio Armani lasting silk UV compact foundation Octinoxate and Titanium Dioxide POWDER TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 30; 86 mg/g; mg/g 49967-229_7a672eef-693f-4bf0-8df1-6fc782187540 49967-229 HUMAN OTC DRUG LOreal Paris Sublime Sun Advanced Sunscreen SPF 30 Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.64; 4.4; 4.4; 6.16; 5.28 mL/88mL; mL/88mL; mL/88mL; mL/88mL; mL/88mL 49967-232_bc5df22b-6723-47aa-a920-ccbf1c4d9a64 49967-232 HUMAN OTC DRUG Vichy Laboratoires Normaderm Daily Gentle Cleanser Salicylic Acid CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 5 mg/mL 49967-243_44b68d0f-9522-4bf6-9297-b37ffbf20cef 49967-243 HUMAN OTC DRUG Giorgio Armani Lasting Silk UV Foundation Broad Spectrum SPF 20 Sunscreen Octinoxate and Titanium dioxide LOTION TOPICAL 20090301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 30; 62 mg/mL; mg/mL 49967-250_b5c53917-3b09-4d4e-92d0-6585d62982b8 49967-250 HUMAN OTC DRUG Lancome Paris Absolue Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Replenishing Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 30; 80 mg/mL; mg/mL; mg/mL 49967-254_babdd55a-b25b-41a0-9300-e5e890a717bc 49967-254 HUMAN OTC DRUG Vichy Laboratoires Liftactiv Retinol HA Broad Spectrum SPF 18 Sunscreen Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL 49967-261_b30eddf8-b356-4167-a66c-8281a51e48bf 49967-261 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense Broad Spectrum SPF 20 Sunscreen Avobenzone Homosalate Octisalate Octocrylene LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.5; 2.35; 2.5; 3.5 mL/50mL; mL/50mL; mL/50mL; mL/50mL 49967-264_152cb574-13b4-48ff-9fa8-c34f7b61b43f 49967-264 HUMAN OTC DRUG Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 Sunscreen Titanium Dioxide CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 11.5 mg/mL 49967-272_98384153-6258-48da-8aab-604cef6bc45c 49967-272 HUMAN OTC DRUG Kiehls Since 1851 CrossTerrain Antiperspirant Deodorant 24 Hour Strong Dry Aluminum Chlorohydrate STICK TOPICAL 20100601 OTC MONOGRAPH FINAL part350 L'Oreal USA Products Inc ALUMINUM CHLOROHYDRATE 15 g/75g 49967-279_d65bec5f-0428-46ba-80a9-9ffa201ccb56 49967-279 HUMAN OTC DRUG Kiehls Since 1851 Facial Fuel UV Guard Fast Absorbing Sunscreen for Men SPF 50 Plus Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 7.5; 2.5; 2.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL 49967-280_f6d8c1c4-8fcf-4d26-8b9a-1494a9981d7a 49967-280 HUMAN OTC DRUG LOreal Paris Magic Nude Bare Skin Perfecting Makeup OCTINOXATE LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL 49967-283_05c41935-c5d0-4925-bb81-aea968e2924c 49967-283 HUMAN OTC DRUG Dermablend Professional Leg and Body Cover Full Coverage Body Foundation with SPF 15 Sunscreen Titanium dioxide LOTION TOPICAL 20081117 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE .97 mL/100mL 49967-288_ec6e0f0d-1092-42af-aac0-e797dc231092 49967-288 HUMAN OTC DRUG Dermablend Leg and Body Cover Titanium Dioxide LOTION TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 10 mg/mL 49967-295_a069dbcf-2e09-4548-bd01-e99ca777ad05 49967-295 HUMAN OTC DRUG LOreal Paris Men Expert Comfort Max Hydra Energetic After Shave Balm Broad Spectrum SPF 15 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20131219 OTC MONOGRAPH NOT FINAL part352 L?Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL 49967-311_9028aa46-2554-48e8-936c-6cd63bd4601a 49967-311 HUMAN OTC DRUG Dermablend Cover Titanium Dioxide CREAM TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 30 mg/g 49967-319_d3c0eb7b-79f5-4167-8aab-7f0a24ec3d72 49967-319 HUMAN OTC DRUG Garnier Skin Renew Dark Spot Hand Treatment Broad Spectrum SPF 30 Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL 49967-324_a217c36e-2346-475f-a764-5ff83d5f5204 49967-324 HUMAN OTC DRUG LOreal Paris Advanced Suncare Silky Sheer 30 Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 50; 50; 70; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-325_9eef55b0-2c62-4e74-affe-60a53b0ffbb9 49967-325 HUMAN OTC DRUG LOreal Paris Advanced Suncare Silky Sheer 50 Plus Broad Spectrum SPF 50 Plus Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-326_2191560d-1cdf-402b-8e2f-d233aae1a919 49967-326 HUMAN OTC DRUG Lancome Paris Renergie Lift Multi Action Broad Spectrum SPF 15 Sunscreen Lifting and Firming for Dry Skin Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/g; mg/g; mg/g 49967-327_e71c28ea-a863-4b3f-a5fa-9f0783621c9f 49967-327 HUMAN OTC DRUG LOreal Paris Advanced Suncare Silky Sheer Face 30 Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-328_638d1aa6-a0d8-4b72-940b-49f63bf9244d 49967-328 HUMAN OTC DRUG LOreal Paris Advanced Suncare Silky Sheer Face 50 Plus Broad Spectrum SPF 50 Plus Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-332_8b243497-5497-4ba5-b294-a16e6ffe3a77 49967-332 HUMAN OTC DRUG Vichy Laboratoires Normaderm Triple Action 3 in 1 Cleanser Salicylic Acid CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 5 mg/mL 49967-333_c46bd6b2-f95c-46a6-bc56-2811628ba80a 49967-333 HUMAN OTC DRUG LOreal Paris Advanced Suncare Invisible Protect Sheer 30 Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 70 mg/g; mg/g; mg/g; mg/g 49967-334_f17a4a41-192a-43cb-8e3e-d58ab6929470 49967-334 HUMAN OTC DRUG LOreal Paris Advanced Suncare Invisible Protect Sheer 50 Plus Broad Spectrum SPF 50 Plus Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 70; 60 mg/g; mg/g; mg/g; mg/g; mg/g 49967-345_415c896c-044d-4e07-b698-2377e9ec4fe9 49967-345 HUMAN OTC DRUG Garnier Moisture Rescue Lightweight UV Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 50 mg/mL; mg/mL; mg/mL 49967-347_994d0f46-5c50-4a17-9bed-e658d4f09676 49967-347 HUMAN OTC DRUG Vichy Normaderm Total Mat Salicylic Acid LOTION TOPICAL 20130201 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 5 mg/mL 49967-352_e2391223-6609-4982-9dca-d2de94208504 49967-352 HUMAN OTC DRUG Yves Saint Laurent Forever Youth Liberator Avobenzone Octisalate Octocrylene CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.05; 1.75; 2.45 mL/50mL; mL/50mL; mL/50mL 49967-357_93034a24-a2c3-490f-98d3-b4ae9d6030da 49967-357 HUMAN OTC DRUG LOreal Paris Sublime Sun 30 Crystal Clear Sunscreen Mist Broad Spectrum SPF 30 Water Resistant Avobenzone, Homosalate, Octisalate and Octocrylene AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 70 mg/g; mg/g; mg/g; mg/g 49967-358_d7f55afc-6f68-4bf6-adc7-041f5441aed0 49967-358 HUMAN OTC DRUG LOreal Paris Sublime Sun Advanced Sunscreen SPF 30 Crystal Clear Mist Avobenzone Homosalate Octisalate Octocrylene AEROSOL, SPRAY TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3.75; 12.5; 6.25; 8.75 mL/125mL; mL/125mL; mL/125mL; mL/125mL 49967-359_6ff4609d-932a-4d25-9a42-c89c7c9502cc 49967-359 HUMAN OTC DRUG LOreal Paris Sublime Sun Advanced Sunscreen SPF 50 Plus Crystal Clear Mist Avobenzone Homosalate Octisalate Octocrylene Oxybenzone AEROSOL, SPRAY TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.75; 18.75; 6.25; 8.75; 8.75 mL/125mL; mL/125mL; mL/125mL; mL/125mL; mL/125mL 49967-369_a4966e4b-bd68-41f2-a00a-74df690a5651 49967-369 HUMAN OTC DRUG LOreal Paris Sublime Sun Advanced Sunscreen SPF 50 Plus Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.64; 13.2; 4.4; 4.4; 5.28 mL/88mL; mL/88mL; mL/88mL; mL/88mL; mL/88mL 49967-371_d25ddcee-d093-472a-a843-d004d6445a3c 49967-371 HUMAN OTC DRUG LOreal Paris Sublime Sun Advanced Sunscreen SPF 50 Plus Liquid Silk Sunshield For Face Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 7.5; 2.5; 2.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL 49967-372_bec766c1-6854-45e2-87d8-e12a1a23d9e6 49967-372 HUMAN OTC DRUG LOreal Paris Sublime Sun Advanced Sunscreen SPF 30 Hydra Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.6; 14.4; 6; 8.4; 7.2 g/120g; g/120g; g/120g; g/120g; g/120g 49967-373_da38ae12-0735-4bde-8047-a8b18f216322 49967-373 HUMAN OTC DRUG LOreal Paris Sublime Sun Advanced Sunscreen SPF 50 Plus Hydra Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.6; 18; 6; 8.4; 7.2 g/120g; g/120g; g/120g; g/120g; g/120g 49967-382_db4d13f8-fd4b-4642-b4a9-13c889b63c34 49967-382 HUMAN OTC DRUG Kiehls Since 1851 CrossTerrain UV Skin Protector SPF 50 Water and Sweat Resistant Sunscreen Avobenzone Homosalate Octisalate Octocrylene Oxybenzone OINTMENT TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.2; 4; 2; 3; 2 g/40g; g/40g; g/40g; g/40g; g/40g 49967-384_d03fe21a-7585-4fa5-8b08-6d210cca7ead 49967-384 HUMAN OTC DRUG Lancome Paris BB Bienfait Teinte Beauty Balm Broad Spectrum SPF 30 Sunscreen Octinoxate and Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 75; 58 mg/mL; mg/mL 49967-388_d1a45667-c38a-4243-b25d-2fef1658878e 49967-388 HUMAN OTC DRUG Mizani Scalp Care Antidandruff Pyrithione Zinc SHAMPOO TOPICAL 20080601 OTC MONOGRAPH FINAL part358H L'Oreal USA Products Inc PYRITHIONE ZINC 10 mg/mL 49967-389_831af106-e4d7-4d83-a45e-f46cfe5c51f3 49967-389 HUMAN OTC DRUG Mizani Scalp Care Conditioner Antidandruff Conditioner Pyrithione Zinc LOTION TOPICAL 20080601 OTC MONOGRAPH FINAL part358H L'Oreal USA Products Inc PYRITHIONE ZINC 10 mg/mL 49967-390_cc5e4c54-4ad3-42d5-956d-dc623325259f 49967-390 HUMAN OTC DRUG Mizani Scalp Care PreTreatment Antidandruff Treatment Salicylic Acid LOTION TOPICAL 20080601 OTC MONOGRAPH FINAL part358H L'Oreal USA Products Inc SALICYLIC ACID 30 mg/mL 49967-392_0374ac05-4607-4657-b0bd-82091a3f5be1 49967-392 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 30 Cooling Water Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 22.4; 80; 24; 44.8; 28.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-405_bbaf8a28-ff0c-4a63-8367-a4d5eaa1b972 49967-405 HUMAN OTC DRUG Vichy Laboratoires Normaderm Triple Action Antiacne Hydrating Salicylic Acid LOTION TOPICAL 20110301 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 10 mg/mL 49967-413_fbb96945-1b89-4151-99d5-2f87134982e7 49967-413 HUMAN OTC DRUG SkinCeuticals Ultimate UV Defense Broad Spectrum SPF 30 Sunscreen Octinoxate and Zinc Oxide CREAM TOPICAL 20050101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; ZINC OXIDE 75; 70 mg/mL; mg/mL 49967-416_049caeff-2d7a-43ec-bb0f-2876a2ba0294 49967-416 HUMAN OTC DRUG Vichy Laboratoires ProEven Mineral BB Broad Spectrum SPF 20 Sunscreen Octinoxate and Titanium Dioxide CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 50; 80 mg/mL; mg/mL 49967-422_7b2ea3af-0bd8-474e-bb84-0d242c2d96f6 49967-422 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Rosaliac Daily Complete Tone Correcting Broad Spectrum SPF 30 Sunscreen CC Octinoxate, Octisalate, Octocrylene and Titanium Dioxide CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 30; 35; 45; 62 mg/mL; mg/mL; mg/mL; mg/mL 49967-425_20c14623-7a01-4003-9711-9b83b22d03c4 49967-425 HUMAN OTC DRUG LOreal Paris True Match Naturale gentle mineral makeup Broad Spectrum SPF 19 Titanium Dioxide POWDER TOPICAL 20060701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 100 mg/g 49967-427_941858bb-8672-421f-8fd8-d5225e9480c4 49967-427 HUMAN OTC DRUG Maybelline New York Dream Nude Airfoam Air Infused Makeup Sunscreen Broad Spectrum SPF 16 Octinoxate, Octisalate and Octocrylene AEROSOL, FOAM TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; OCTISALATE; OCTOCRYLENE 71.2; 23.8; 9.5 mg/g; mg/g; mg/g 49967-428_cff13883-e1c9-48a4-9ebb-f84fead0514b 49967-428 HUMAN OTC DRUG Maybelline New York Dream Nude Airfoam Air Infused Foundation SPF 16 Octinoxate Octisalate Octocrylene AEROSOL, FOAM TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; OCTISALATE; OXYBENZONE 3.2752; 1.0948; .437 g/46g; g/46g; g/46g 49967-444_2fcdcbec-bc0f-486c-b239-4f5e5d283080 49967-444 HUMAN OTC DRUG Kiehls Since 1851 Dermatologist Solutions Super Fluid UV Defense Ultra Light Sunscreen SPF 50 Plus Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 7.5; 2.5; 2.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL 49967-445_ace0402a-c529-42f7-865a-077f72a23f69 49967-445 HUMAN OTC DRUG Kiehls Since 1851 Dermatologist Solutions Skin Tone Correcting and Beautifying BB Sunscreen Homosalate, Octisalate, Octocrylene and Titanium dioxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc HOMOSALATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 100; 50; 50; 45 mg/mL; mg/mL; mg/mL; mg/mL 49967-452_eeededf6-b965-49eb-bbfd-3a8fa8c12eb1 49967-452 HUMAN OTC DRUG Maybelline New York Baby Lips Moisturizing Lip Balm SPF 20 Octinoxate Octisalate LIPSTICK TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; OCTISALATE .33; .132 g/4.4g; g/4.4g 49967-453_e5425723-8a7e-49d8-af21-2b0d7921b69d 49967-453 HUMAN OTC DRUG Maybelline New York Baby Lips Peppermint Moisturizing Lip Balm SPF 20 Sunscreen Octinoxate and Octisalate LIPSTICK TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; OCTISALATE 75; 30 mg/g; mg/g 49967-456_350fa1c3-a58f-4b6a-9093-1197b77388cc 49967-456 HUMAN OTC DRUG Lancome Paris Bienfait MultiVital Broad Spectrum SPF 30 Sunscreen Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20060701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/g; mg/g; mg/g 49967-457_35b96198-786e-456f-b428-6845319defd3 49967-457 HUMAN OTC DRUG Garnier Nutritioniste Moisture Rescue Lightweight UV SPF 15 Ensulizole Octinoxate LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc ENSULIZOLE; OCTINOXATE 2; 10 mL/133mL; mL/133mL 49967-472_f3da2da9-8bb5-4dbe-b60f-2261967b6cf6 49967-472 HUMAN OTC DRUG SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 Sunscreen Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 40 mg/mL; mg/mL 49967-475_bcb31086-feec-421c-b1d8-2972f1c52f0c 49967-475 HUMAN OTC DRUG LOreal Paris True Match Lumi Healthy Luminous Makeup Broad Spectrum SPF 20 Octinoxate LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 70 mg/mL 49967-479_bb68d4f6-f940-4cf9-8463-04bc4dd40b1e 49967-479 HUMAN OTC DRUG Ralph Lauren Romance Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20120701 OTC MONOGRAPH FINAL part350 L'Oreal USA Products Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 1.2 g/75g 49967-483_b07afc2e-2d2e-4785-bbc3-4b62c6333461 49967-483 HUMAN OTC DRUG Kerastase Specifique Bain Exfoliant Hydratant Pyrithione Zinc SHAMPOO TOPICAL 20120701 OTC MONOGRAPH FINAL part358H L'Oreal USA Products Inc PYRITHIONE ZINC 10 mg/mL 49967-489_2fb6153d-ab24-411d-a1db-8092d6190813 49967-489 HUMAN OTC DRUG Maybelline New York Baby Lips Dr Rescue Medicated Balm Menthol LIPSTICK TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part348 L'Oreal USA Products Inc MENTHOL 5 mg/g 49967-495_3772f9d4-9bbf-4d14-814a-690b85fa6ce7 49967-495 HUMAN OTC DRUG Kiehls Since 1851 Dermatologist Solutions Acne Blemish Control Daily Skin Clearing Treatment Salicylic Acid LOTION TOPICAL 20081101 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 15 mg/mL 49967-501_47622cc0-aa2d-48f6-9692-02c42e971e66 49967-501 HUMAN OTC DRUG Kiehls Since 1851 Broad Spectrum SPF 30 Sunscreen Powerful Wrinkle Reducing Avobenzone, Homosalate, Octisalate and Octocrylene CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 27; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL 49967-502_3a0671c2-f6cf-4b38-a964-f1d43f7a8d67 49967-502 HUMAN OTC DRUG Lancome Paris High Resolution Refill 3X Triple Action Renewal Anti Wrinkle Broad Spectrum SPF 15 Sunscreen Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 30 mg/g; mg/g; mg/g 49967-503_1e713f04-5ac0-4747-9fe5-a3fecc578b5c 49967-503 HUMAN OTC DRUG Lancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Octinoxate and Titanium Dioxide LIQUID TOPICAL 20071101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 70; 17 mg/mL; mg/mL 49967-505_eb643342-e048-4372-83d1-222af306d07f 49967-505 HUMAN OTC DRUG Yves Saint Laurent Rouge Pur Couture Pure Colour Satiny Radiance Octinoxate LIPSTICK TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE .076 g/3.8g 49967-506_201f4bab-f76f-41b7-824c-ac188cee0874 49967-506 HUMAN OTC DRUG Lancome Paris Teint Miracle Lit From Within Makeup Broad Spectrum SPF 15 Sunscreen Octinoxate LIQUID TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL 49967-513_f92930b8-ed9d-4b34-b21e-0daa47b6aae8 49967-513 HUMAN OTC DRUG VICHY LABORATOIRES DERMAFINISH CORRECTIVE FOUNDATION TITANIUM DIOXIDE LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 156.752 mg/mL 49967-516_3127f5d1-21a0-4381-8eda-7bdeb899be6d 49967-516 HUMAN OTC DRUG Lancome Teint Miracle Lit from within Makeup SPF 15 Sunscreen Octinoxate LIQUID TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE .9 mL/30mL 49967-521_a0b0b7f3-bb21-4d0b-a927-2df1151e6259 49967-521 HUMAN OTC DRUG Yves Saint Laurent Terre Saharienne Bronzing Octinoxate POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE .6 g/10g 49967-524_dbcde648-fa77-4110-ba60-fc4c36f13f5d 49967-524 HUMAN OTC DRUG Maybelline New York Baby Lips Quenched Moisturizing Lip Balm SPF 20 Sunscreen Octinoxate and Octisalate LIPSTICK TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; OCTISALATE 75; 30 mg/g; mg/g 49967-542_15b9ddb9-8c7c-428c-81cf-bc5bf40ea3e4 49967-542 HUMAN OTC DRUG Lancome Bienfait UV SPF 50 Plus Super Fluid Facial Sunscreen Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 7.5; 2.5; 2.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL 49967-549_a7dd18e5-3edb-4bd6-8871-9fd9a249cb49 49967-549 HUMAN OTC DRUG Lancome Paris Star Bronzer Long Lasting Bronzer SPF 15 Octinoxate POWDER TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE .975 g/13g 49967-553_5a52baf6-bbd9-4ddd-9804-e2a8e9a7b7ec 49967-553 HUMAN OTC DRUG LOreal Paris Advanced Suncare Invisible Protect Clear Cool 30 Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 29.6; 87.8; 48.8; 59.2 mg/mL; mg/mL; mg/mL; mg/mL 49967-554_059788ae-c7c2-4ffa-98b7-618ea402f10b 49967-554 HUMAN OTC DRUG LOreal Paris Advanced Suncare Invisible Protect Clear Cool 50 Plus Broad Spectrum SPF 50 Plus Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 107.2; 32.1; 60; 38.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-555_bb58310d-e3c7-4a50-9c61-d2961f242134 49967-555 HUMAN OTC DRUG LOreal Paris Advanced Suncare Silky Sheer Face 30 Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20131220 OTC MONOGRAPH NOT FINAL part352 L?Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 29.6; 87.8; 48.8; 59.2 mg/mL; mg/mL; mg/mL; mg/mL 49967-556_eae45c4c-2586-43df-85ca-578c863855d7 49967-556 HUMAN OTC DRUG LOreal Paris Advanced Suncare Silky Sheer BB Face 50 Plus Broad Spectrum SPF 50 Plus Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20131220 OTC MONOGRAPH NOT FINAL part352 L?Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 107.2; 32.1; 60; 38.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-564_affb6a5c-31c5-4f06-932e-5a85dd5aa1e4 49967-564 HUMAN OTC DRUG Lancome Tropiques Minerale Mineral Smoothing Pressed Bronzer SPF 15 Sunscreen Octinoxate POWDER TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE .75 g/10g 49967-575_3191179f-6c2a-4887-9deb-41dfe5491dd5 49967-575 HUMAN OTC DRUG Giorgio Armani Face Fabric Second Skin Nude Makeup Broad Spectrum SPF 12 Sunscreen Octinoxate LOTION TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 20 mg/mL 49967-583_9908ca14-5b5d-423b-b4be-69701dcc4584 49967-583 HUMAN OTC DRUG Kiehls Since 1851 Facial Fuel Energizing Moisture Treatment for Men Broad Spectrum SPF 15 Sunscreen Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 50 mg/mL; mg/mL; mg/mL 49967-585_7204ddf4-9435-4ba3-a290-724bc1e266c6 49967-585 HUMAN OTC DRUG Giorgio Armani Luminessence CC Color Control Bright Moisturizer Broad Spectrum SPF 35 Sunscreen Octinoxate and Titanium Dioxide LOTION TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part352 -L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 50; 18.5 mg/mL; mg/mL 49967-593_99c4619c-a118-47fb-a7a2-74bff18d5f55 49967-593 HUMAN OTC DRUG Yves Saint Laurent Forever Youth Liberator Ensulizole Octinoxate LOTION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc ENSULIZOLE; OCTINOXATE 1; 3.745 mL/50mL; mL/50mL 49967-595_4a481259-f2f5-45c6-a009-39f4a3a0d5be 49967-595 HUMAN OTC DRUG Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 Sunscreen Titanium dioxide LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 110 mg/mL 49967-596_84899a0c-0868-40b3-a079-3df252aeda5e 49967-596 HUMAN OTC DRUG Lancome Paris Absolue Makeup Broad Spectrum SPF 20 Sunscreen Absolute Replenishing Makeup for Dry and Very Dry Skin Octinoxate CREAM TOPICAL 20071101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 75 mg/mL 49967-605_82cc5529-1725-4383-be3f-36adb41cc905 49967-605 HUMAN OTC DRUG em michelle phan the everything tinted makeup cc Titanium Dioxide CREAM TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 11.5 mg/mL 49967-610_3578c6ad-3ebc-4bf9-b560-224fa66dcfe7 49967-610 HUMAN OTC DRUG LOreal Paris Visible Lift CC Broad Spectrum SPF 20 Light Medium Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL 49967-611_abddabd8-f5d0-48c8-8440-55f1bd096142 49967-611 HUMAN OTC DRUG LOreal Paris Visible lift Medium Deep CC Broad Spectrum SPF 20 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL 49967-626_0db963b4-78dd-4696-a60e-f10217201f10 49967-626 HUMAN OTC DRUG Yves Saint Laurent Top Secrets All In One BB Octinoxate CREAM TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 74.9 mg/mL 49967-627_57d31ffd-f7d1-4c2e-8343-f2285da0236d 49967-627 HUMAN OTC DRUG LOreal Paris Advanced Suncare Invisible Protect Dry 15 Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene SPRAY TOPICAL 20131220 OTC MONOGRAPH NOT FINAL part352 L?Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL 49967-628_b47dba11-6adc-4173-a15c-a21a87cba0f3 49967-628 HUMAN OTC DRUG LOreal Paris Advanced Suncare Invisible Protect Dry 30 Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene SPRAY TOPICAL 20131223 OTC MONOGRAPH NOT FINAL part352 L?Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL 49967-629_a6077557-0bb1-438f-88e0-208d89078261 49967-629 HUMAN OTC DRUG LOreal Paris Advanced Suncare Invisible Protect Dry 50 Plus Broad Spectrum SPF 50 Plus Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20131223 OTC MONOGRAPH NOT FINAL part352 L?Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 70; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-631_005196f7-52ae-4e44-b0ef-9d5329413484 49967-631 HUMAN OTC DRUG Kiehls Since 1851 Activated Sun Protector for Face Broad Spectrum SPF 50 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-641_ef80a097-aa26-4c25-a5cb-d566478086fc 49967-641 HUMAN OTC DRUG Lancome Paris Renergie Lift Multi Action All Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/g; mg/g; mg/g 49967-644_db19d4ba-48c3-40d2-ae56-6571a06e30a7 49967-644 HUMAN OTC DRUG Garnier Ultra Lift Anti Wrinkle Firming Moisturizer Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 30 mg/mL; mg/mL; mg/mL 49967-645_ce099258-98e0-4386-a0fa-551a04350995 49967-645 HUMAN OTC DRUG Lancome Paris Renergie Lift MultiAction Dry Avobenzone Octisalate Octocrylene CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 2.5; 3.5 g/50g; g/50g; g/50g 49967-651_ac123b6a-3001-4fd0-8f19-567c9fc2a69a 49967-651 HUMAN OTC DRUG LOreal Paris Visible Lift Line Minimizing and Tone Enhancing Makeup Broad Spectrum SPF 17 Octinoxate LIQUID TOPICAL 20030101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 60 mg/mL 49967-658_f4aeb471-97b6-49bc-998e-5821def2fb13 49967-658 HUMAN OTC DRUG LOreal Paris Age Perfect Glow Renewal Day Moisturizer Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL 49967-659_d4cb050f-8427-4aa4-a9a0-c1489fb7289f 49967-659 HUMAN OTC DRUG LOreal Paris true match super blendable compact makeup Broad Spectrum SPF 17 Octinoxate CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 49 mg/g 49967-664_06034bae-3526-41a2-9af4-d063bd9259f4 49967-664 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Pigmentclar Daily Dark Spot Correcting Moisturizer Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL 49967-671_3f0702b0-cce5-4ae5-87e6-a653b317d0d4 49967-671 HUMAN OTC DRUG Garnier Skin Naturals Lift SPF 15 Day Ensulizole Octinoxate CREAM TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc ENSULIZOLE; OCTINOXATE .85; 3.75 mL/50mL; mL/50mL 49967-686_18bbd72e-c426-4861-994b-205578044d18 49967-686 HUMAN OTC DRUG LOreal Paris Skin Expertise Revitalift Deep-Set Wrinkle Repair Eye Cream 24 Hour Eye Repair Duo SPF 15 Avobenzone Octisalate Octocrylene LOTION TOPICAL 20090601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE .18; .3; .18 mL/6mL; mL/6mL; mL/6mL 49967-689_f22ca315-4298-4207-8570-8737e71949d6 49967-689 HUMAN OTC DRUG LOreal Paris Revitalift Clinical Repair 10 SPF 20 Avobenzone Homosalate Octisalate Octocrylene LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.5; 5; 2.5; 3.5 mL/50mL; mL/50mL; mL/50mL; mL/50mL 49967-699_480d73af-42ba-41a8-8dc9-ed2c1bf17808 49967-699 HUMAN OTC DRUG Garnier Skin Renew Daily Moisture Anti Sun Damage Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL 49967-700_49b73b92-cf55-4d0d-89dd-9f67a7bce04b 49967-700 HUMAN OTC DRUG SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 30 Sunscreen Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 50 mg/mL; mg/mL 49967-703_acf4ab21-e1d3-42ee-903b-2e3afdbe359c 49967-703 HUMAN OTC DRUG LOreal Paris Advanced Suncare Quick Dry Sheer Finish 50 Plus Broad Spectrum SPF 50 Plus Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 107.2; 32.1; 60; 38.6 mg/g; mg/g; mg/g; mg/g; mg/g 49967-707_f087048f-0691-4d52-81a5-ac5c61664ac1 49967-707 HUMAN OTC DRUG Kiehls Since 1851 Dermatologist Solutions Activated Sun Protector Sunscreen Broad Spectrum SPF 50 For Body Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.5; 22.5; 7.5; 7.5; 9 mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL 49967-709_43059da3-b4d8-4663-9a53-f02b7ce6f3ed 49967-709 HUMAN OTC DRUG Garnier Ultra Lift Deep Wrinkle Intensive Day Avobenzone, Homosalate, Octisalate and Octocrylene CREAM TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 20; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL 49967-710_c0f8b8d2-4a4a-46ff-82a5-d26d83092927 49967-710 HUMAN OTC DRUG LOreal Paris Visible Lift Repair Absolute Rapid Age Reversing Makeup Broad Spectrum SPF 16 Sunscreen Titanium Dioxide CREAM TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 61 mg/g 49967-713_99ea31b8-6707-40d5-af52-91d4660b209d 49967-713 HUMAN OTC DRUG Giorgio Armani Maestro Sunscreen Fusion Makeup SPF 15 Octinoxate LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE .9 mL/30mL 49967-715_a5f9168f-e918-400a-87cc-dd49a238cba5 49967-715 HUMAN OTC DRUG Maybelline New York Fit Me Foundation Octinoxate LIQUID TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 2.1 mL/30mL 49967-724_cf3d4439-b9f5-4654-ae7f-a5a5fd49d383 49967-724 HUMAN OTC DRUG LOreal Paris Youth Code Broad Spectrum SPF 15 BB Octinoxate and Titanium Dioxide CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 40; 36 mg/mL; mg/mL 49967-728_b769e02b-64a6-4567-ab04-e5a3cb37c961 49967-728 HUMAN OTC DRUG La Roche Posay Redermic C UV Sunscreen Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL 49967-754_2659d3fd-7de4-4233-ae19-62ba8969cae7 49967-754 HUMAN OTC DRUG Lancome Paris Bienfait UV 50 Plus Broad Spectrum SPF 50 Plus Water Resistant 80 Minutes Super Fluid Facial Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-759_ea31bf3f-4e38-40aa-8196-3c4f9971422c 49967-759 HUMAN OTC DRUG Cerafill Retaliate Minoxidil SOLUTION TOPICAL 20140428 ANDA ANDA074588 L'oreal Usa, Inc. MINOXIDIL 20 mg/mL 49967-760_8b004074-42c0-439c-82cb-91fb27591a35 49967-760 HUMAN OTC DRUG Cerafill Retaliate Extra Strength For Men Minoxidil SOLUTION TOPICAL 20140428 ANDA ANDA075518 L'oreal Usa, Inc. MINOXIDIL 50 mg/mL 49967-770_fd42173b-1e79-4db4-bdb5-d73d63fd0d53 49967-770 HUMAN OTC DRUG SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 Sunscreen Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 50 mg/mL; mg/mL 49967-779_d031ae94-34dc-4403-99ff-b08082b9c44b 49967-779 HUMAN OTC DRUG Garnier Skin Renew Miracle Skin Perfector BB Octinoxate and Titanium Dioxide CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 40; 21 mg/mL; mg/mL 49967-789_126a8f7e-7b73-46b4-a776-f9f1d3438296 49967-789 HUMAN OTC DRUG Yves Saint Laurent Le Teint Encre De Peau Fusion Ink Foundation Broad Spectrum SPF 18 Sunscreen Octinoxate LOTION TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL 49967-790_d3365441-0254-47d8-b63a-a2d71fdbe852 49967-790 HUMAN OTC DRUG Kiehls Since 1851 Facial Fuel UV Guard Broad Spectrum SPF 50 Plus Sunscreen WR80 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-795_28f8c826-1e3a-4025-9298-3a97a8af1105 49967-795 HUMAN OTC DRUG Redken 5th Avenue NYC Scalp Relief Dandruff Control Pyrithione Zinc SHAMPOO TOPICAL 20060817 OTC MONOGRAPH FINAL part358H L'Oreal USA Products Inc PYRITHIONE ZINC 10 mg/mL 49967-797_8af7b757-3166-44ba-aaf8-39623acce125 49967-797 HUMAN OTC DRUG Kiehls Since 1851 Ultra Facial Moisturizer Broad Spectrum SPF 30 Sunscreen For All Skin Types Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 70; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL 49967-800_4a1d6766-5e60-4a7c-9188-e74b8eebb6d1 49967-800 HUMAN OTC DRUG SkinCeuticals Clarifying Cleanser Salicylic Acid CREAM TOPICAL 20050801 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 20 mg/mL 49967-803_412d07ba-64a2-4aea-a0e0-532c67e8ac86 49967-803 HUMAN OTC DRUG Giorgio Armani Maestro Fusion Makeup Compact Broad Spectrum SPF 29 Sunscreen Octinoxate CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 50 mg/g 49967-810_d9a45be4-295a-4bba-9aec-3905a2d66661 49967-810 HUMAN OTC DRUG Yves Saint Laurent Youth Liberator Serum Foundation Octinoxate LOTION TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 40 mg/mL 49967-839_d1f9d415-0941-4e2d-ba4f-3fc131b11cb8 49967-839 HUMAN OTC DRUG Lancome Teint Idole Ultra 24H Makeup SPF 15 Sunscreen Octinoxate LOTION TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE .9 mL/30mL 49967-844_582e0e14-683c-439e-bf7a-c487b601adb0 49967-844 HUMAN OTC DRUG LOreal Paris Visible Lift Instant Age Reversing Foundation SPF 17 Octinoxate Titanium Dioxide LIQUID TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 1.375; 2.225 mL/25mL; mL/25mL 49967-857_46f7ed04-be77-4dfb-b46c-6645e4981e99 49967-857 HUMAN OTC DRUG Lancome Paris Renergie Lift Volumetry Volumetric Lifting and Reshaping SPF 15 Normal Combination Skin Avobenzone Octisalate Octocrylene CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 2.5; 3.5 g/50g; g/50g; g/50g 49967-859_28d52669-5d96-40a2-be17-d49919e3eecf 49967-859 HUMAN OTC DRUG Lancome Paris Renergie Lift Volumetry Volumetric Lifting and Reshaping SPF 15 Normal to Dry Skin Avobenzone Octisalate Octocrylene CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 2.5; 3.5 g/50g; g/50g; g/50g 49967-860_a867b6d9-d118-4a9b-bcab-b91272f2cf3d 49967-860 HUMAN OTC DRUG Lancome Paris Flash Bronzer AntiAge Tinted Antiage SelfTanning Face Lotion SPF 15 Avobenzone Homosalate Octisalate Octocrylene LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2.5; 3.5 mL/50mL; mL/50mL; mL/50mL; mL/50mL 49967-862_7e4e431b-7373-479f-a8fc-400ffafa5671 49967-862 HUMAN OTC DRUG LOreal Paris Skin Expertise Revitalift Complete SPF 30 Day AntiWrinkle and Firming Moisturizer Avobenzone Homosalate Octisalate Octocrylene LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.5; 2.35; 2.5; 3.5 mL/50mL; mL/50mL; mL/50mL; 1/50mL 49967-863_1d665e84-5a8f-4a31-98c4-fb05f03f2304 49967-863 HUMAN OTC DRUG LOreal Paris true match super blendable makeup broad spectrum spf 17 Titanium Dioxide LIQUID TOPICAL 20050101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 32.6 mg/mL 49967-882_00971c47-11c9-4d12-b6e6-919f956cd52a 49967-882 HUMAN OTC DRUG Kiehls Since 1851 Superbly Efficient Antiperspirant and Deodorant Aluminum chlorohydrate CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part350 L'Oreal USA Products Inc ALUMINUM CHLOROHYDRATE 128 mg/mL 49967-891_fd7088c6-9abb-4d59-8955-07fdb8fc4d8c 49967-891 HUMAN OTC DRUG Vichy Laboratoires Capital Soleil SPF 50 Ultra Light Sunscreen Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 5; 2.5; 2.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL 49967-893_b84f61db-412f-4307-b50f-5b17b3f44a0a 49967-893 HUMAN OTC DRUG LOreal Paris Visible lift Serum Absolute Advanced Age Reversing Makeup Broad Spectrum SPF 17 Octinoxate and Titanium Dioxide LIQUID TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 10; 67 mg/mL; mg/mL 49967-898_c1a2a599-2c5c-43e3-bc4c-f4cd3fe303d6 49967-898 HUMAN OTC DRUG Lancome Paris Teint Idole Fresh Wear Enduring Shine Free Makeup Broad Spectrum SPF 15 Sunscreen Octinoxate LIQUID TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL 49967-899_c1cf188a-1514-4890-b965-af26f354f22b 49967-899 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Titanium Dioxide LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 110 mg/mL 49967-902_4b3d6edf-223b-4001-8104-55e5905ffef6 49967-902 HUMAN OTC DRUG Lancome Teint Idole Fresh Wear Enduring Shine Free Makeup SPF 15 Sunscreen Octinoxate LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE .72 mL/24mL 49967-907_6c00743d-f150-456f-84e7-298d95c98499 49967-907 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Sunscreen Titanium dioxide and Zinc oxide LOTION TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 50 mg/mL; mg/mL 49967-913_1598c57e-be25-4ca0-8b2b-1ce9626a2e00 49967-913 HUMAN OTC DRUG LOreal Paris Revitalift Miracle Blur Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-933_1926e668-7cdb-407c-8bfb-b6b405f7b9e1 49967-933 HUMAN OTC DRUG SoftSheenCarson Magic Bump Rescue Spot Treatment Salicylic Acid LOTION TOPICAL 20131101 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 20 mg/mL 49967-934_eb34adac-c23e-4d93-8d85-0f37df3334dc 49967-934 HUMAN OTC DRUG LOreal Paris Age Perfect Cell Renewal Day Moisturizer Broad Spectrum SPF 15 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 50 mg/g; mg/g; mg/g; mg/g 49967-944_c4e29d44-4661-4d88-925c-9498371fcb32 49967-944 HUMAN OTC DRUG LOreal Paris Men Expert Vita Lift Daily Moisturizer Sunscreen Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20131219 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 20; 50; 55 mg/mL; mg/mL; mg/mL; mg/mL 49967-952_8f67ca76-a05c-43b6-b845-2aa40642b421 49967-952 HUMAN OTC DRUG Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating Day Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 20; 50; 80 mg/g; mg/g; mg/g 49967-957_3cdec159-ac84-451d-b371-7c6b0137c43a 49967-957 HUMAN OTC DRUG Maybelline Dream Pure BB Beauty Balm Salicylic Acid LOTION TOPICAL 20140601 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 20 mg/mL 49967-969_a633efc4-c6c4-46df-8587-fb55049eb3c9 49967-969 HUMAN OTC DRUG Maybelline New York Fit Me Foundation Dewy Plus Smooth SPF 18 Sunscreen Octinoxate LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 70 mg/mL 49967-972_9cb35f7c-21b1-4b55-bebc-d2fdace7f52b 49967-972 HUMAN OTC DRUG Garnier Skin Renew Miracle Skin Perfector Combination to Oily Skin BB Broad Spectrum SPF 20 Sunscreen Octinoxate and Titanium dioxide CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 30; 47 mg/mL; mg/mL 49967-980_fae075a9-15f8-4f3b-beb8-f8e95b21aa1e 49967-980 HUMAN OTC DRUG LOreal Paris Visible Lift Blur Foundation Broad Spectrum SPF 18 Sunscreen Octinoxate LOTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 75 mg/mL 49967-981_5052e77f-56b7-4867-a558-48c5fe2983af 49967-981 HUMAN OTC DRUG LOreal Paris Ideal Moisture Normal Skin Broad Spectrum SPF 25 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL 49967-982_3eeb1eb4-e496-4f3c-9493-3f1dfd6001bf 49967-982 HUMAN OTC DRUG LOreal Paris Ideal Moisture Dry Skin Broad Spectrum SPF 25 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 20; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL 49967-983_92c311d4-84d7-45e0-a872-028d2efdbe65 49967-983 HUMAN OTC DRUG LOreal Paris Ideal Moisture Sensitive Skin Broad Spectrum SPF 25 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 20; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL 49967-984_fce64240-4337-499d-8972-9b7b707d71e9 49967-984 HUMAN OTC DRUG LOreal Paris Ideal Moisture Even Skin Tone Moisturizer Broad Spectrum SPF 25 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL 49967-993_ffdb4947-4d96-42da-8b9e-282740526a84 49967-993 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 60 Ultra Light Sunscreen Fluid Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 107.2; 32.1; 60; 38.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 49967-999_e96957f6-36ef-46b8-bbbf-d1d364727872 49967-999 HUMAN OTC DRUG Vichy Laboratoires Capital Soleil 30 Sunscreen Luxurious Protective Avobenzone Homosalate Octisalate Octocrylene Oxybenzone OIL TOPICAL 20120307 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 5.31; 26.55; 8.85; 12.39; 10.62 mL/177mL; mL/177mL; mL/177mL; mL/177mL; mL/177mL 49969-001_9a4ddddf-0ca7-4988-919b-974958cb7811 49969-001 HUMAN OTC DRUG Jun Wai Lung Medicine Pain relieving Camphor Menthol Methyl Salicylate OIL TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part348 Wah Sing Pharmaceutical Limited CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 10; 15; 33 g/100mL; g/100mL; g/100mL 49969-002_616dd1ab-b262-493a-9cc9-76b04e70e3e7 49969-002 HUMAN OTC DRUG Zihuadick Pain relieving Camphor Menthol Methyl Salicylate LIQUID TOPICAL 20131230 OTC MONOGRAPH NOT FINAL part348 Wah Sing Pharmaceutical Limited CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3; 10; 10 g/100mL; g/100mL; g/100mL 49972-001_09fa9785-b76d-4fc6-8bb3-883d97d8eaca 49972-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Praxair Distribution Southeast LLC OXYGEN 990 mL/L 49972-002_e13e1878-48f5-4f9a-bc2a-77fc21dc6eaa 49972-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Praxair Distribution Southeast LLC NITROGEN 990 mL/L 49972-003_039a0d72-7c14-4a26-b1de-e7015caa19af 49972-003 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20080901 UNAPPROVED MEDICAL GAS Praxair Distribution Southeast LLC CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 49972-004_845551da-0662-4741-bb99-2b834f8c97f3 49972-004 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Praxair Distribution Southeast LLC NITROUS OXIDE 990 mL/L 49972-006_32884d25-191f-4a8c-bef7-5864b4a15fff 49972-006 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20020501 UNAPPROVED MEDICAL GAS Praxair Distribution Southeast LLC AIR 1000 mL/L 49972-008_6acbb947-9026-4329-aad2-0b4adf2375c2 49972-008 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mix Carbon Dioxide Oxygen Mix GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Praxair Distribution Southest LLC CARBON DIOXIDE; OXYGEN 300; 700 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 49972-009_1a00ab3c-4e4f-4c78-876c-9a973789b7d7 49972-009 HUMAN PRESCRIPTION DRUG Helium Oxygen mixture Helium Oxygen mixture GAS RESPIRATORY (INHALATION) 20070801 UNAPPROVED MEDICAL GAS Praxair Distribution Southeast LLC HELIUM; OXYGEN 800; 200 mL/L; mL/L 49972-010_8bb5643c-ffd6-462e-aa8f-821b54937b4a 49972-010 HUMAN PRESCRIPTION DRUG Helium Oxygen Nitrogen mixture Helium Oxygen Nitrogen mixture GAS RESPIRATORY (INHALATION) 20051001 UNAPPROVED MEDICAL GAS Praxair Distribution Southeast LLC HELIUM; NITROGEN; OXYGEN 200; 300; 500 mL/L; mL/L; mL/L 49973-244_f592b65d-456f-4cea-b288-6daf6bd35001 49973-244 HUMAN OTC DRUG AZO Urinary Pain Relief TABLET ORAL 20120518 UNAPPROVED DRUG OTHER i-Health, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 49973-245_57a0fc53-42db-42e2-9982-16ada0fd9e39 49973-245 HUMAN OTC DRUG AZO Urinary Pain Relief TABLET ORAL 20140304 UNAPPROVED DRUG OTHER i-Health, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 49973-301_1e2a6c2f-3df7-4f07-b218-3aa5efd2e89e 49973-301 HUMAN OTC DRUG AZO Urinary Pain Relief TABLET ORAL 20120524 UNAPPROVED DRUG OTHER i-Health, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 49973-606_7597b3c7-2fa7-4a91-b90f-32a64f3434aa 49973-606 HUMAN OTC DRUG AZO Yeast Eupatorium Perfoliatum Flowering Top and Viscum Album Leaf TABLET ORAL 20120522 UNAPPROVED HOMEOPATHIC i-Health, Inc. EUPATORIUM PERFOLIATUM FLOWERING TOP; VISCUM ALBUM LEAF 5; 5 [hp_X]/1; [hp_X]/1 49973-667_66137af6-89d6-435f-bf43-5a1e19018ed6 49973-667 HUMAN OTC DRUG AZO Yeast Plus Candida Albicans, Wood Creosote, Sodium Chloride, and Sulfur TABLET ORAL 20141001 UNAPPROVED HOMEOPATHIC i-Health, Inc. CANDIDA ALBICANS; SODIUM CHLORIDE; SULFUR; WOOD CREOSOTE 30; 12; 12; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 49973-760_a8aa0528-6988-45f0-8fff-8b0184a112f5 49973-760 HUMAN PRESCRIPTION DRUG AZO Urinary Tract Health Phenazopyridine Hydrochloride TABLET ORAL 20140228 UNAPPROVED DRUG OTHER i-Health, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 49973-761_57355928-2301-4f98-b6d9-5c8a541d0a70 49973-761 HUMAN OTC DRUG AZO Urinary Pain Relief Phenazopyridine Hydrochloride TABLET ORAL 20141101 UNAPPROVED DRUG OTHER i-Health, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 49980-001_263af858-1edb-47ab-8ef5-928a86695024 49980-001 HUMAN OTC DRUG Zhenweilong Huoluo You External Analgesic Camphor Menthol Methyl Salicylate OIL TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part348 Hong Kong Zihua Pharmaceutical Ltd. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 10; 15; 30 g/100mL; g/100mL; g/100mL 49980-003_6f8edaf3-ed18-49f4-93fb-e39e191a85cf 49980-003 HUMAN OTC DRUG ZIHUA EMBROCATION Cooling Pain Relief Camphor Menthol Methyl Salicylate OIL TOPICAL 20140415 OTC MONOGRAPH NOT FINAL part348 Hong Kong Zihua Pharmaceutical Ltd. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 11; 15; 15 g/100mL; g/100mL; g/100mL 49981-001_64bad65e-2db3-49e3-8a5f-bbae6424f883 49981-001 HUMAN OTC DRUG Jasmine Rose Hand Wash Nettoyant Pour Les Mains None Hand Wash LIQUID TOPICAL 20091112 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g 49981-002_5a3df9d3-ac22-487f-a888-811ba2b0979f 49981-002 HUMAN OTC DRUG Hand Wash Nettoyant Pour Les Mains Orange Pekoe None Hand Wash LIQUID TOPICAL 20091115 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g 49981-003_7abab773-55b2-4d33-b499-d841b4ac0f61 49981-003 HUMAN OTC DRUG Hand Wash Nettoyant Pour Les Mains Vallina Tuberose None Hand Wash LIQUID TOPICAL 20091115 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g 49981-004_d7d37c8a-5e38-455b-9626-c47336490f1e 49981-004 HUMAN OTC DRUG Hand Wash Nettoyant Pour Les Mains Plum Grapefruit None Hand Wash LIQUID TOPICAL 20091116 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g 49981-005_66c815bc-afa2-4db8-891e-669857c89ebc 49981-005 HUMAN OTC DRUG Hand Wash Nettoyant Pour Les Mains Citrus Cilantro None Hand Wash LIQUID TOPICAL 20091116 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g 49981-007_646fe108-8ec7-4ac5-bfd2-bda0a442fb88 49981-007 HUMAN OTC DRUG Pier 1 Imports Coconut Breeze Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g 49981-008_6cbebeea-b8ae-4f19-b015-b174fbd2b5a0 49981-008 HUMAN OTC DRUG Pier 1 Imports Ocean Water Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g 49981-009_3aa02027-ef00-438e-8d4d-7bd296d42143 49981-009 HUMAN OTC DRUG Pier 1 Imports Lily Flower Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g 49981-010_3647eb43-25cb-4baa-9423-68e43ce254ea 49981-010 HUMAN OTC DRUG Pier 1 Imports Sweet Cherry Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g 49981-011_9c0b7379-8276-4b95-84e2-c3c777faf4cd 49981-011 HUMAN OTC DRUG Pier 1 Imports Warm Vanilla Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g 49981-012_8b3bfcbd-ebc1-4100-823f-14ee5ce37a44 49981-012 HUMAN OTC DRUG Pier 1 Imports Cool Watermelon Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g 49981-013_3beda4f1-7b13-49a5-8900-422ccccafca3 49981-013 HUMAN OTC DRUG Pier 1 Imports Sweet Orange Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g 49981-014_ea8c9409-72d6-4d5d-a583-39d0ba5543d2 49981-014 HUMAN OTC DRUG Pier 1 Imports Granny Smith Apple Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g 49981-016_f467a19d-71b3-4f7f-ac67-d6c96c0813f7 49981-016 HUMAN OTC DRUG Pier 1 Imports Citrus and Sunflowers Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g 49981-017_87358109-1e2b-4ab7-acb6-0d5ccde111f7 49981-017 HUMAN OTC DRUG Pier 1 Imports Sweet Grape Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g 49981-018_f3f49066-7e24-4243-b202-36f938612d42 49981-018 HUMAN OTC DRUG Body Blends Apple Attraction Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd ALCOHOL 62 g/100g 49981-019_4075c19c-9704-40fd-ad18-cb26fddff5be 49981-019 HUMAN OTC DRUG Body Blends Citrus Awakening Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd ALCOHOL 62 g/100g 49981-020_8afd6ec7-13e7-4f1c-92a1-57457d1f9c42 49981-020 HUMAN OTC DRUG Body Blends Coconut Lime Escape Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd ALCOHOL 62 g/100g 49981-021_fc92e622-c701-4b34-983e-d182520a630a 49981-021 HUMAN OTC DRUG Body Blends Vanilla Sugar Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd ALCOHOL 62 g/100g 49981-022_c59fa27c-b9f1-4538-ae16-baa196461303 49981-022 HUMAN OTC DRUG Friuts and Flowers Clean Cotton Waterless Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100810 OTC MONOGRAPH NOT FINAL part333E Xiamen Anna Global Co., Ltd ALCOHOL 62 g/100g 49981-023_230c20f0-9a63-4e00-9ea3-1cf45266bfaa 49981-023 HUMAN OTC DRUG Friuts and Flowers Grapefruit Waterless Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100810 OTC MONOGRAPH NOT FINAL part333E Xiamen Anna Global Co., Ltd ALCOHOL 62 g/100g 49989-515_5a9e1728-8a4b-4608-96f4-7115405927a8 49989-515 HUMAN OTC DRUG JANITECH JAN-HS-40 INSTANT HAND SANITIZER alcohol GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 CHEM-SALES INC. ALCOHOL 600 mL/1000mL 49991-001_ce25e2f5-f431-4c82-acd9-5984c12f2efb 49991-001 HUMAN OTC DRUG Rich Girl Hand Avobenzone, Octinoxate, and Octisalate CREAM TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part352 Lippmann Enterprises, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 2; 7.5; 5 g/100g; g/100g; g/100g 49993-860_a6232b52-e181-42a1-9140-b096cf7dd43f 49993-860 HUMAN OTC DRUG Glo Scinece Antioxidant Fluoride PASTE, DENTIFRICE DENTAL 20120601 OTC MONOGRAPH FINAL part355 GLO Science Inc SODIUM MONOFLUOROPHOSPHATE .84 g/100g 49993-861_cc10ab81-f079-4582-aa58-26259b026d41 49993-861 HUMAN OTC DRUG Glo Science Antioxidant Fluoride PASTE, DENTIFRICE DENTAL 20120601 OTC MONOGRAPH FINAL part355 GLO Science Inc SODIUM MONOFLUOROPHOSPHATE .84 g/100g 49997-356_b5858372-b8af-4805-b3ac-4e2c5d2152e4 49997-356 HUMAN OTC DRUG RhinoBlaster Nasal Spray SPRAY NASAL 20100203 UNAPPROVED HOMEOPATHIC JD888 LLC CHILI PEPPER 6 [hp_X]/30mL 49998-332_462cee25-b508-4d40-9b67-acd87bb3a3d1 49998-332 HUMAN OTC DRUG Trival Homeopathic Alopecia Areata Treatment TINCTURE TOPICAL 20091222 UNAPPROVED HOMEOPATHIC TE-Point Doo FAGUS SYLVATICA NUT; FRAGARIA VESCA FRUIT; GARLIC; OLEA EUROPAEA FLOWER; ST. JOHN'S WORT; URTICA URENS 1; 1; 1; 1; 2; 1 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 49999-002_d83e501b-3a28-420b-8328-b72d457d765f 49999-002 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062936 Lake Erie Medical DBA Quality Care Products LLC PENICILLIN V POTASSIUM 250 mg/1 49999-003_65cfa8ab-d15e-490d-a998-c4edd1a3e2bb 49999-003 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 Lake Erie Medical DBA Quality Care Products LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 49999-004_9ef162e8-808c-4f46-a452-d797921c0118 49999-004 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-006_37077c26-adf8-41a1-85c0-a72d3995966a 49999-006 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20111121 ANDA ANDA078558 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-007_5ae70f3a-23c9-4155-b2b6-09d03666541d 49999-007 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20111108 ANDA ANDA065215 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CEPHALEXIN 500 mg/1 49999-008_ed2164dd-754c-4a7b-b5e9-5a846ba6be92 49999-008 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20111130 ANDA ANDA080356 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PREDNISONE 5 mg/1 49999-009_86f77c8e-2b8e-42f8-9d12-72695e31aed1 49999-009 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100928 ANDA ANDA076494 Lake Erie Medical DBA Quality Care Products LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-010_903166ca-b15e-41ff-be51-12032eac63b9 49999-010 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20110127 ANDA ANDA073288 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49999-011_389ad9cc-f8d9-4e1c-843b-42522e9206da 49999-011 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20110201 ANDA ANDA063083 Lake Erie Medical DBA Quality Care Products LLC CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 49999-011_982a2fef-7a63-4e22-9736-ec26afe7cde7 49999-011 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20101108 ANDA ANDA063083 Lake Erie Medical DBA Quality Care Products LLC CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 49999-012_a3038fbe-b3dc-4014-a6cc-3754d572632b 49999-012 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN Base Filmtab ERYTHROMYCIN TABLET, FILM COATED ORAL 20120312 ANDA ANDA061621 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 49999-015_096d74f3-5508-4f70-b858-29a6a2fe5282 49999-015 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20111215 ANDA ANDA065291 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 49999-016_84215220-0f17-4c23-91ae-ce4241a5fb90 49999-016 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 49999-017_ae4bb83f-a217-4fed-bc40-8a803dfa7b69 49999-017 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111107 ANDA ANDA089160 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49999-018_d0858938-2bf5-404c-b149-88c4e2fbadad 49999-018 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20111129 ANDA ANDA071321 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49999-020_6ef25d95-4d05-4899-a33a-7dda5e54415c 49999-020 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20111207 ANDA ANDA065095 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DOXYCYCLINE HYCLATE 100 mg/1 49999-020_ba1c1248-12c7-446d-a0af-cebd584bca43 49999-020 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20111207 ANDA ANDA065095 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DOXYCYCLINE HYCLATE 100 mg/1 49999-022_d5c6d0c7-5220-429c-b699-1afaf542bd67 49999-022 HUMAN PRESCRIPTION DRUG ULTRAM tramadol hydrochloride TABLET, COATED ORAL 20120320 NDA NDA020281 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 49999-024_d4f26263-0a5c-461a-b736-6f7a705f0edc 49999-024 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20111121 ANDA ANDA040804 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 49999-028_6ea91fb9-8a41-4824-b21a-a427886cc84c 49999-028 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20100811 ANDA ANDA040256 Lake Erie medical DBA Quality Care Products LLC PREDNISONE 10 mg/1 49999-029_64a522ae-6995-4906-a014-6a578d0c13b1 49999-029 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120123 ANDA ANDA087128 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 49999-030_09430977-e9b9-4f66-87f2-0ecff8cb1128 49999-030 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20111128 ANDA ANDA018569 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 49999-032_cdfe44a1-4b6a-4813-b4e5-f80e2f841913 49999-032 HUMAN PRESCRIPTION DRUG Alprazolam ALPRAZOLAM TABLET ORAL 20100401 ANDA ANDA074112 Lake Erie Medical DBA Quality Care Products LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49999-034_5c9eb2d2-de6b-422a-bce9-d9e9a427bb58 49999-034 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20100701 ANDA ANDA078218 Lake Erie Medical DBA Quality Care Product LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49999-035_0a21b01f-3bdb-488e-9c12-4dd1e31645f3 49999-035 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20111128 ANDA ANDA091176 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 49999-037_75163499-092e-4dd7-bf02-8c7bbface1b9 49999-037 HUMAN PRESCRIPTION DRUG Ambien zolpidem tartrate TABLET, FILM COATED ORAL 20090630 NDA NDA019908 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 49999-038_cd46a6ca-e30f-49a6-a411-12d083036c80 49999-038 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20111219 ANDA ANDA074903 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-039_8bfbef1a-d5f3-4c5f-a58e-d34aa46f6c70 49999-039 HUMAN PRESCRIPTION DRUG Alprazolam ALPRAZOLAM TABLET ORAL 20100401 ANDA ANDA074112 Lake Erie Medical DBA Quality Care Products LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49999-042_d005c655-fe7c-4eef-bac8-67774dc91a68 49999-042 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20101019 ANDA ANDA076112 Lake Erie Medical DBA Quality Care Products LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-044_41348867-7110-40f8-be0a-da7becda2669 49999-044 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110412 ANDA ANDA089859 Lake Erie Medical DBA Quality Care Products LLC CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49999-045_ddd8a501-0ce2-4002-b98f-91e82b2cafb1 49999-045 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20110803 ANDA ANDA070920 Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49999-046_e33e1451-7da8-4ed4-b0b8-87e98e4622ea 49999-046 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 20110207 ANDA ANDA040284 Lake Erie Medical DBA Quality Care Products LLC ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49999-047_9b9b22e8-e9f6-48ac-8b76-8c8acd1ada87 49999-047 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Lake Erie Medical DBA Quality Care Products LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 49999-048_9f10c663-3b60-4a8f-9a10-988d5fd9f1a0 49999-048 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20111116 ANDA ANDA085159 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49999-049_6a4a31c6-d756-4714-b6e2-1153eb4e6962 49999-049 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20111104 ANDA ANDA078250 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-050_f3afcca3-2a9f-4369-8a48-e5e8703ae30a 49999-050 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 Lake Erie Medical DBA Quality Care Products LLC PENICILLIN V POTASSIUM 500 mg/1 49999-051_9f511e95-b671-47d4-a086-db59060fb679 49999-051 HUMAN PRESCRIPTION DRUG Vicodin Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19830107 ANDA ANDA088058 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49999-052_0773748c-98f2-42d5-9bae-652169815f04 49999-052 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100823 ANDA ANDA040468 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49999-052_56b9c50c-26e4-4bce-9653-877c3fa8d73f 49999-052 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100925 ANDA ANDA040468 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49999-053_e10c015b-5e8c-45ab-96f5-d16aca3ebae9 49999-053 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111103 ANDA ANDA040201 Lake Erie Medical &Surgical Supply DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49999-055_3fb7a9e3-269f-47b7-bd57-695506ccdc40 49999-055 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 20110601 ANDA ANDA074224 Lake Erie Medical DBA Quality Care Products LLC TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49999-057_04db5fd2-ab83-4fd1-81af-5567b72905c4 49999-057 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 Lake Erie Medical DBA Quality Care Products LLC METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 49999-059_ee2d8f9f-58fc-4bc0-8517-a0d787650d63 49999-059 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49999-060_9b3147e7-218a-4aa6-9242-db2f993535b3 49999-060 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET ORAL 20111215 ANDA ANDA040419 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII 49999-063_8ab7effa-ac01-43b2-952d-00773b32556e 49999-063 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA085966 Lake Erie Medical DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 49999-065_3fc75cfc-d309-48aa-aa45-a6004b65c71d 49999-065 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20101116 ANDA ANDA084276 Lake Erie Medical DBA Quality Care Products LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49999-065_ce88a296-63b8-40ec-ad68-7e5077d99fea 49999-065 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20101123 ANDA ANDA084276 Lake Erie Medical DBA Quality Care Products LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49999-066_f35bf878-5638-468f-8fd2-237752037331 49999-066 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide triamterene and hydrochlorothiazide CAPSULE ORAL 20110504 ANDA ANDA074701 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 49999-068_2f776f8a-0db6-41aa-8265-4f2a07d62bda 49999-068 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET ORAL 19970109 ANDA ANDA074661 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NAPROXEN SODIUM 220 mg/1 49999-071_01e0cf61-39c8-448b-a0dd-d81578fcec6a 49999-071 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20120216 OTC MONOGRAPH NOT FINAL part343 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC IBUPROFEN 200 mg/1 49999-074_fb7fb7bc-b028-4889-9e2d-54e7a346d123 49999-074 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 19940126 ANDA ANDA074131 Lake Erie Medical DBA Quality Care Products LLC PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-075_3285d7a5-7842-47df-825b-d2e3326aa8ab 49999-075 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090917 ANDA ANDA078906 Lake Erie Medical DBA Quality Care Products LLC VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 49999-077_b110ddfe-6222-435b-b167-cb64119c505d 49999-077 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Double Strength Sulfamethoxazole and Trimethoprim TABLET ORAL 20101020 NDA AUTHORIZED GENERIC NDA018598 Lake Erie Medical DBA QualityL Care Products LC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 49999-081_d04ae61e-1bae-4933-b556-295644c28d88 49999-081 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 20111118 ANDA ANDA085223 Lake Erie Medical DBA Quality Care Products LLC DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 49999-083_9f73eaf3-3241-45f7-802c-f186a89a413c 49999-083 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20120312 ANDA ANDA040114 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 49999-089_9b5af30c-6623-4a81-a2fb-d8a2034d447c 49999-089 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20120410 ANDA ANDA075185 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-090_1e7c2c4c-fe7a-400b-8ae2-218463d68d47 49999-090 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20101124 ANDA ANDA083426 Lake Erie Medical DBA Quality Care Products LLC PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 49999-090_e445e585-721a-44ba-b974-b42b4ca51f37 49999-090 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20101028 ANDA ANDA083426 Lake Erie Medical DBA Quality Care Products LLC PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 49999-091_2e2089e9-7b65-4e4a-9eff-f1c74af022d7 49999-091 HUMAN OTC DRUG diphenhydramine hydrochloride diphenhydramine hydrochloride CAPSULE ORAL 20111205 OTC MONOGRAPH FINAL part341 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 49999-094_130a0a1e-a6a6-416a-91a0-838ca83df486 49999-094 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA071851 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49999-095_e41ae0ce-bd73-4964-a17f-d9bf5d909f01 49999-095 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20120316 NDA NDA070033 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 49999-097_37077c26-adf8-41a1-85c0-a72d3995966a 49999-097 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20111121 ANDA ANDA078558 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-099_e9a44ccf-5780-45cc-b32e-9639b354bd7d 49999-099 HUMAN OTC DRUG ACETAMINOPHEN PAIN RELIEF Acetaminophen TABLET ORAL 20120202 OTC MONOGRAPH FINAL part343 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ACETAMINOPHEN 500 mg/1 49999-100_3f023acc-0f91-41a4-9fae-4f3f587209b0 49999-100 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20110420 ANDA ANDA070756 Lake Erie Medical DBA Quality Care Products LLC INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-102_ccf28938-de23-4a68-b1a0-64aa71ee0ea4 49999-102 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20100826 ANDA ANDA075280 Lake Erie Medical DBA Quality Care Products LLC NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-103_c41c45d4-30ce-49bf-b0e4-2d4aae89181f 49999-103 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20101116 ANDA ANDA078671 Lake Erie Medical DBA Quality Care Products LLC NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-103_fe6c654c-c600-4267-aebc-6eb49d401e5f 49999-103 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20101123 ANDA ANDA078671 Lake Erie Medical DBA Quality Care Products LLC NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-104_bbace905-4b89-4675-840a-e26b31937c4b 49999-104 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100524 ANDA ANDA077877 Lake Erie Medical DBA Quality Care Products LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49999-106_5c7c3712-7c07-41d9-a1fe-f90ef9bca318 49999-106 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110127 ANDA ANDA077095 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49999-107_784d4a19-6056-4fb3-b306-00f5363e2ba8 49999-107 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20110531 ANDA ANDA074223 Lake Erie Medical DBA Quality Care Products LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49999-108_4eda2774-ce9d-44cc-9a89-e200c89efab4 49999-108 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Lake Erie Medical DBA Quality Care Products LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49999-109_22e955ea-1b9a-40cf-b2fa-c2a6313a9ed8 49999-109 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20120321 NDA NDA004782 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ESTROGENS, CONJUGATED .625 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 49999-110_6a2778a4-edb1-41a5-a26c-90ea5e3f3f9d 49999-110 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20111130 ANDA ANDA040392 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PREDNISONE 20 mg/1 49999-113_3d774b4a-3054-46c9-a86d-58094a6a8dec 49999-113 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20110223 ANDA ANDA074388 Lake Erie Medical DBA Quality Care Products LLC GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 49999-115_46e2ef91-04a8-46ac-8773-f3c9486e25c9 49999-115 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine TABLET ORAL 20120223 ANDA ANDA086162 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 49999-116_75d518d6-fc15-489d-a523-fd2f7e854edd 49999-116 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 49999-118_1786e75f-e280-4a1f-8f93-3d0d1e9d303f 49999-118 HUMAN PRESCRIPTION DRUG ULTRACET tramadol hydrochloride and acetaminophen TABLET ORAL 20120320 NDA NDA021123 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 49999-120_d47b3cbf-d3bf-4aae-87a4-14da55ed6476 49999-120 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 20120319 ANDA ANDA062286 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 49999-121_78c2e2ae-9cd4-48c8-a33d-1f9ee6e26e86 49999-121 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20111219 ANDA ANDA074979 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49999-122_352fbf71-dfcd-4795-8f51-50c0914368b7 49999-122 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110131 ANDA ANDA072927 Lake Erie Medical DBA Quality Care Products LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49999-126_6862e000-ee1a-4617-9e6b-7178b2d6e40d 49999-126 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20120416 ANDA ANDA062676 Lake Erie Medical DBA Quality Care Products LLC DOXYCYCLINE HYCLATE 100 mg/1 49999-127_9aae0be6-31a7-40af-b23b-4f999fb45289 49999-127 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20100519 ANDA ANDA070317 Lake Erie Medical DBA Quality Care Products LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 49999-128_6880c6d1-48b3-45a0-9093-417cb24f7dde 49999-128 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20100819 ANDA ANDA075049 Lake Erie Medical DBA Quality Care Products LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-129_5fe522c9-de34-4222-90e7-f22722be7b4d 49999-129 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20110207 ANDA ANDA075964 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 49999-130_fbb8b618-b374-4799-80f2-e57df5b0618f 49999-130 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20101117 ANDA ANDA074761 Lake Erie Medical DBA Quality Care Products LLC KETOROLAC TROMETHAMINE 10 mg/1 49999-131_8c506cc1-97c9-4029-b197-070f2c483021 49999-131 HUMAN OTC DRUG Mapap ACETAMINOPHEN TABLET ORAL 20110421 OTC MONOGRAPH NOT FINAL part343 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN 325 mg/1 49999-133_878fa968-f8d1-482c-bff8-206032c3378f 49999-133 HUMAN OTC DRUG Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20120323 OTC MONOGRAPH FINAL part349 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC POLYVINYL ALCOHOL 14 mg/mL 49999-136_fbb8ef16-82eb-47e3-8ddb-c938c2c05382 49999-136 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 20100118 ANDA ANDA062447 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 49999-138_b0a345f4-009c-4ca6-8267-e074633559f1 49999-138 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 20120312 ANDA ANDA064048 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 49999-139_74947ad5-fc98-4d0e-b3a4-3b268c1e6132 49999-139 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 19760430 ANDA ANDA080693 Lake Erie Medical DBA Quality Care Products LLC HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49999-140_ceb9d58b-727e-445f-83e8-69351703905d 49999-140 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19950710 ANDA ANDA040014 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 49999-141_963565fc-b682-48d2-98a6-7d2ebe02786f 49999-141 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone neomycin sulfate, polymyxin b sulfate and dexamethasone SUSPENSION OPHTHALMIC 19960221 ANDA ANDA062341 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49999-142_f82fe29a-dcd5-4f31-8f96-7e898cbb19e1 49999-142 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20120319 OTC MONOGRAPH FINAL part333B Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BACITRACIN 500 [USP'U]/g 49999-143_3028f759-2298-4f22-a3b5-7b54d5e8430e 49999-143 HUMAN PRESCRIPTION DRUG SILVADENE silver sulfadiazine CREAM TOPICAL 19731126 NDA NDA017381 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 49999-144_fdbfa5ca-e859-489f-b500-5b87944ba67b 49999-144 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium sulfacetamide sodium SOLUTION/ DROPS OPHTHALMIC 19941228 ANDA ANDA040066 Lake Erie Medical DBA Quality Care Products LLC SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 49999-148_a4e51ef9-ebaa-49e2-af70-c436cd540fb2 49999-148 HUMAN PRESCRIPTION DRUG Tobramycin tobramycin SOLUTION OPHTHALMIC 19940525 ANDA ANDA063176 Lake Erie Medical DBA Quaity Care Products LLC TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 49999-150_ada3bb42-1e2e-4218-880c-aab95acb652f 49999-150 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20120320 ANDA ANDA086414 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49999-151_403222f5-78a8-4dc7-b2ae-004829e2cd77 49999-151 HUMAN PRESCRIPTION DRUG Butalbital Acetaminophen and Caffeine Butalbital Acetaminophen and Caffeine TABLET ORAL 20101011 ANDA ANDA088616 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 49999-151_97b7ecd9-5917-4abd-9d35-70de39aa7135 49999-151 HUMAN PRESCRIPTION DRUG Butalbital Acetaminophen and Caffeine Butalbital Acetaminophen and Caffeine TABLET ORAL 20101011 ANDA ANDA088616 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 49999-152_4977b1d6-57d7-4630-a62c-66c0a10c3da3 49999-152 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20120321 ANDA ANDA040650 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CV 49999-153_ccfdb5dc-27b2-4f1f-aaee-16190cb04a92 49999-153 HUMAN PRESCRIPTION DRUG Methylprednisolone methylprednisolone TABLET ORAL 20120209 NDA NDA011153 Lake Erie Medical DBA Quality Care Products LLC METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49999-154_c953233a-30cd-4801-9d64-9704897fbe1f 49999-154 HUMAN OTC DRUG triple antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20110307 OTC MONOGRAPH FINAL part333B Lake Erie Medical DBA Quality Care Products LLC BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 49999-155_808fa018-29d2-4dca-abda-a5e28f49553d 49999-155 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20101001 ANDA ANDA073192 Lake Erie Medical DBA Quality Care Products LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 49999-156_6ed90754-6395-4126-a6c5-c1c523739211 49999-156 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20111214 ANDA ANDA071524 Lake Erie Medical DBA Quality Care Products LLC TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 49999-158_e31c18ee-9fd8-40f9-871a-033f22369ee5 49999-158 HUMAN PRESCRIPTION DRUG Diflucan fluconazole TABLET ORAL 19900129 NDA NDA019949 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 49999-159_a0e3b94b-4eac-40ab-9895-e0cf62a866e1 49999-159 HUMAN PRESCRIPTION DRUG Gentak Gentamicin Sulfate OINTMENT OPHTHALMIC 20120327 ANDA ANDA064093 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 49999-162_a239a410-be74-43f6-836b-a4e93bf06edb 49999-162 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20120206 ANDA ANDA089414 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49999-167_a7ed311b-ff8f-4d90-ab44-863e21daa20f 49999-167 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20120328 ANDA ANDA084878 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49999-169_c5ffda4b-51b2-49b3-afe0-b213514e55b1 49999-169 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20111103 ANDA ANDA040148 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49999-172_89b8b3f8-ae11-4a39-ad11-91aa0fe3f2e3 49999-172 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19840626 NDA NDA019117 Lake Erie Medical DBA Quality Care Products LLC FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49999-176_9b9b22e8-e9f6-48ac-8b76-8c8acd1ada87 49999-176 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Lake Erie Medical DBA Quality Care Products LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 49999-177_4c062dd6-bc16-48e3-be7c-87f683b98ed5 49999-177 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20111215 ANDA ANDA065063 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 49999-180_b250e3af-f354-4a14-bc3d-55399d9b29ec 49999-180 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Lake Erie Medical DBA Quality Care Products LLC DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 49999-182_d8798e6a-bfd2-4d88-897d-1f055d7d2245 49999-182 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20120327 ANDA ANDA077321 Lake Erie Medical Quality Care Products LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49999-183_7d814126-0fb8-41c9-a0e3-f7471c2f1f4e 49999-183 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20110719 ANDA ANDA075994 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49999-184_0ce79c31-9d4e-4cd9-b641-ad698731e67b 49999-184 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 19951030 ANDA ANDA064064 Lake Erie Medical DBA Quality Care Products LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 10000 [USP'U]/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] 49999-185_1f879e75-4324-497e-920c-da822c06bcdb 49999-185 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 20120322 ANDA ANDA018578 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 49999-190_e6d803d1-1b9c-4b15-86a8-60b444a35df5 49999-190 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20120305 ANDA ANDA070791 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 49999-192_44a25a39-42e3-451f-9f1a-93abd766b4b1 49999-192 HUMAN OTC DRUG Guiatuss Guaifenesin SYRUP ORAL 20120312 OTC MONOGRAPH FINAL part341 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC GUAIFENESIN 100 mg/5mL 49999-205_4d43f252-ba19-48d8-8efa-4168d179ba1e 49999-205 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20111031 ANDA ANDA085969 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 49999-206_7008ee78-4878-41d7-9e95-3f6ac8985ba7 49999-206 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20001020 ANDA ANDA075536 Lake Erie Medical DBA Quality Care Products LLC DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49999-207_35badd9f-a240-4fe3-ad28-29dfa0f1826d 49999-207 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 49999-210_dc03827d-8da0-4ac1-9d91-91217ff84fbc 49999-210 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20120403 ANDA ANDA073652 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 49999-215_784fd6a8-7696-4266-abef-9dad3c78e407 49999-215 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20110127 ANDA ANDA074132 Lake Erie Medical DBA Quality Care Products LLC NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 49999-218_f64f024c-3234-4b2f-b521-6307323722cd 49999-218 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate CREAM TOPICAL 19830831 NDA NDA018861 Lake Erie Medical DBA Quality Care Products LLC BETAMETHASONE VALERATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49999-222_758e95db-4d65-484f-925b-965e70e902e9 49999-222 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20120326 ANDA ANDA019137 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49999-223_b0497216-052b-4284-8da2-9dc75f7659b3 49999-223 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20120326 ANDA ANDA075673 Lake Erie Medical DBA Quality Care Products LLC BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE .5; 10 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49999-226_083987d0-6ca8-43cf-84d3-cd43db2a25ef 49999-226 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20120316 ANDA ANDA078459 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49999-227_ccc64f09-b121-4e10-9665-3e1f25608dc3 49999-227 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075317 Lake Erie Medical DBA Quality Care Products LLC TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49999-228_fb2f3471-0169-4eaa-9a11-c32129ba651b 49999-228 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20100901 ANDA ANDA040218 Lake Erie Medical DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 49999-229_e3fc76f3-5f73-438a-ae28-61301c00833a 49999-229 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20110223 ANDA ANDA075209 Lake Erie Medical DBA Quality Care Products LLC LORATADINE 10 mg/1 49999-230_c993b4bf-ce27-4045-b129-aecd2d2145a4 49999-230 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20111227 ANDA ANDA075805 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 49999-233_9b5af30c-6623-4a81-a2fb-d8a2034d447c 49999-233 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20120410 ANDA ANDA075185 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-237_c993b4bf-ce27-4045-b129-aecd2d2145a4 49999-237 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20111227 ANDA ANDA075805 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 49999-245_87e67e63-589b-4993-b68e-fe12ba54d5ca 49999-245 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20130514 ANDA ANDA090637 Lake Erie Medical DBA Quality Care Products LLC ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 49999-246_c76616cf-31ca-4c57-b299-bbf29ea3e8f5 49999-246 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120308 ANDA ANDA065064 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 49999-248_ec569726-3ddf-4c77-bba8-281acf89d863 49999-248 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 19920731 NDA AUTHORIZED GENERIC NDA019787 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49999-249_0c533e42-f1f6-47ff-b751-3a82c793740a 49999-249 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110131 NDA NDA020699 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-252_b8b0ec82-eb5a-4bb7-a6fd-615571785081 49999-252 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20111130 NDA AUTHORIZED GENERIC NDA018276 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49999-253_5dfd1ccf-fadb-4c39-9ab1-ccfdfa2d2713 49999-253 HUMAN PRESCRIPTION DRUG Alprazolam ALPRAZOLAM TABLET ORAL 20100401 ANDA ANDA074909 Lake Erie Medical DBA Quality Care Products LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49999-254_c0e8537b-687b-4935-b61b-cbc911c46a73 49999-254 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 Lake Erie Medical DBA Quality Care Products LLC HYDROCORTISONE; NEOMYCIN; POLYMYXIN B 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49999-265_c0efb7f4-29ff-4b5c-a2b1-20a2fe9ef19d 49999-265 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE ORAL 20101013 ANDA ANDA075576 Lake Erie Medical DBA Quality Care Products LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 49999-266_8af38fe8-472d-4e63-9d0e-e0e1a78d467e 49999-266 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110131 ANDA ANDA071195 Lake Erie Medical DBA Quality Care Products LLC LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49999-271_5995c9a4-44d3-4713-96d2-d3e516598632 49999-271 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110222 NDA AUTHORIZED GENERIC NDA018279 Lake Erie Medical DBA Quality Care Products LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 49999-277_3162fb28-32ad-4c10-a7c5-47f1e474fd1a 49999-277 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20110205 ANDA ANDA040084 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49999-280_2d71804c-69f7-4baa-a456-25d122e10ed0 49999-280 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate GEL TOPICAL 20100128 ANDA ANDA064160 Lake Erie Medical DBA Quality Care Products LLC CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 49999-286_cf6edbca-404f-404f-a292-ee259c44286d 49999-286 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20120323 ANDA ANDA078955 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49999-290_90e502c8-ee77-4904-8731-5eab82a68e9f 49999-290 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20101108 ANDA ANDA063083 Lake Erie Medical DBA Quality Care Products LLC CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 49999-291_58f0592c-30b5-44b3-b8f2-d89644a64440 49999-291 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19740930 ANDA ANDA084285 Lake Erie Medical DBA Quality Care Products LLC DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 49999-292_55b378c6-34ee-439d-941f-3ebb4793d63c 49999-292 HUMAN PRESCRIPTION DRUG ZOLOFT SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120403 NDA NDA019839 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-293_05df9651-2ae2-43a8-9061-a92f6e18b8cc 49999-293 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 Lake Erie Medical DBA Quality Care Products LLC LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49999-297_63ba1669-1928-419e-a064-9d795c5e62b8 49999-297 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 49999-301_cca26ec9-3389-4865-ab72-5cfdd0a1553e 49999-301 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615 ANDA ANDA075273 Lake Erie Medical DBA Quality Care Products LLC KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 49999-306_e699866f-1386-4b78-8b40-5ce01adef78e 49999-306 HUMAN PRESCRIPTION DRUG ZOCOR simvastatin TABLET, FILM COATED ORAL 20110808 NDA NDA019766 Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49999-307_9e578daf-2591-47e1-a364-db70d772e978 49999-307 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20110225 NDA NDA021153 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 49999-311_769ab3f2-fe6b-4896-b2f2-18ac79a85ed6 49999-311 HUMAN PRESCRIPTION DRUG Flurbiprofen Flurbiprofen TABLET, FILM COATED ORAL 20120307 ANDA ANDA074431 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLURBIPROFEN 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-316_85fbccc0-0a99-45fe-bc1b-90d9bc937a3f 49999-316 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 20110713 NDA NDA020895 Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 49999-318_f54f7e7e-60b2-4344-99c3-80b1674d5b28 49999-318 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20110302 ANDA ANDA086009 Lake Erie Medical DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 49999-321_fe7d03cf-ca3c-43cb-b344-84bc68a6a303 49999-321 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20100811 ANDA ANDA076265 Lake Erie medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49999-324_dd51adf3-2d1a-47da-99a6-8d78ef559497 49999-324 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19870218 ANDA ANDA071293 Lake Erie Medical DBA Quality Care Products LLC AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 49999-327_697fcb3a-f01f-43e7-9d00-f08dbec1a4e8 49999-327 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20120202 ANDA ANDA040201 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49999-328_b06f9053-ec03-4dd8-bccf-28833030070e 49999-328 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20111219 ANDA ANDA074979 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49999-333_92610bec-af36-45e9-ac29-3d93d16bf52f 49999-333 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET ORAL 20120229 ANDA ANDA076794 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49999-334_8808a10a-3a0b-4253-a1c5-6cb616203537 49999-334 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20101103 ANDA ANDA076558 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49999-338_06a878c7-6c0c-42ec-8bb8-b3c414b07c70 49999-338 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP ORAL 20110221 ANDA ANDA073419 Lake Erie Medical DBA Quality Care Products LLC ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 49999-343_6ed90754-6395-4126-a6c5-c1c523739211 49999-343 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20111214 ANDA ANDA071523 Lake Erie Medical DBA Quality Care Products LLC TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 49999-346_7b0089fb-f3e5-4759-a5ec-952ea6c53699 49999-346 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20120214 ANDA ANDA070920 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49999-347_37e3de25-0e0b-40c2-8f35-7f0f445ee284 49999-347 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride TABLET ORAL 20101123 ANDA ANDA076286 Lake Erie Medical DBA Quality Care Products LLC TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 49999-357_190b10b5-388c-491b-86ee-2ee78ddbcd09 49999-357 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Lake Erie Medical DBA Quality Care Products LLC NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49999-362_1d2dc942-a6aa-4d72-8b72-477b518354c2 49999-362 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20110524 ANDA ANDA078619 Lake Erie Medical DBA Quality Care Products LLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-363_9616f09e-c7ec-417d-b9fc-9f10080c2b3f 49999-363 HUMAN PRESCRIPTION DRUG SKELAXIN metaxalone TABLET ORAL 20111214 NDA NDA013217 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49999-367_7e7d6d49-20ac-4daa-82fc-a36392e6337d 49999-367 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20100924 UNAPPROVED DRUG OTHER Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SALSALATE 750 mg/1 49999-371_57b6c5e6-8b4d-461f-af20-f12a9bb48c4a 49999-371 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20111121 ANDA ANDA091549 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-374_0feccef6-a2e3-4c4f-8382-f07d9794b20d 49999-374 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20100401 ANDA ANDA018832 Lake Erie Medical DBA Quality Care Products LLC ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 49999-375_55b378c6-34ee-439d-941f-3ebb4793d63c 49999-375 HUMAN PRESCRIPTION DRUG ZOLOFT SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120403 NDA NDA019839 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-376_089389d4-baed-48fd-b280-98b6e8462cae 49999-376 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20100526 ANDA ANDA075855 Lake Erie Medical DBA Quality Care Products LLC OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-378_36f891ad-0aad-4453-b58b-dcdff0f4aac1 49999-378 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim Sulfate SOLUTION/ DROPS OPHTHALMIC 20120320 ANDA ANDA064120 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 49999-381_1f81a588-58ea-454f-b6b1-4b8dfd26aa96 49999-381 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Extended Release SR Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101004 ANDA ANDA075932 Lake Erie Medical DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49999-383_ed702ddf-33e7-48c3-854e-586445abb5df 49999-383 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 20111122 NDA NDA020998 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-388_2a09e420-e0b1-4168-aab0-01ecf2f1cf60 49999-388 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20111121 NDA AUTHORIZED GENERIC NDA020504 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49999-392_02e0c3d4-29da-49b6-a57b-8bc52b005de5 49999-392 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20120305 NDA NDA020702 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49999-401_986d28a9-030b-4a74-bae4-7ef2c9a74985 49999-401 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20070614 ANDA ANDA076345 Lake Erie Medical DBA Quality Care Products LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 49999-402_0ae01d29-b09b-4d7f-858e-c120da91b6df 49999-402 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 20111213 NDA NDA020839 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 49999-406_d634adab-7540-458d-adee-65a9458d3491 49999-406 HUMAN PRESCRIPTION DRUG Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate OINTMENT OPHTHALMIC 19950130 ANDA ANDA064028 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 49999-411_f0b73405-3aed-4033-80ca-aadcbb711356 49999-411 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20120326 NDA NDA009218 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 49999-418_a3d5b0f5-ab9d-43f4-b86b-e1cbb5bcd92e 49999-418 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 20110127 NDA NDA020634 Lake Erie Medical DBA Quality Care Products LLC LEVOFLOXACIN 500 mg/1 49999-419_44fbc9c4-23c6-4ba1-b332-a847eb3dd782 49999-419 HUMAN PRESCRIPTION DRUG LIDODERM LIDODERM PATCH CUTANEOUS 20111201 NDA NDA020612 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 49999-439_eaf89fa3-caec-4a9c-b36e-5e622946cba9 49999-439 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin and Polymyxin B Sulfates and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 20120124 ANDA ANDA064065 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 10; 10000 mg/mL; mg/mL; [USP'U]/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 49999-447_533dbcc4-1c27-4ab8-80cb-d84f68a4634b 49999-447 HUMAN PRESCRIPTION DRUG AcipHex rabeprazole sodium TABLET, COATED ORAL 20120229 NDA NDA020973 Lake Erie Medical & Surgical Supplies DBA Quality Care Products LLC RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 49999-447_c9fc73c0-dc59-419b-812a-52af6fe7e829 49999-447 HUMAN PRESCRIPTION DRUG AcipHex rabeprazole sodium TABLET, COATED ORAL 20120217 NDA NDA020973 Lake Erie Medical & Surgical Supply DBA Quality Care Produtcs LLC RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 49999-449_4be80657-c3c5-4fc7-bc0a-0dc1ad037e68 49999-449 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 20120217 NDA NDA021073 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 49999-450_4be80657-c3c5-4fc7-bc0a-0dc1ad037e68 49999-450 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 20120217 NDA NDA021073 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 49999-451_4be80657-c3c5-4fc7-bc0a-0dc1ad037e68 49999-451 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 20120217 NDA NDA021073 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 49999-454_9d582f30-72a0-4703-9bec-134b91dad96a 49999-454 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20120418 ANDA ANDA077877 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49999-455_1be7c329-a092-43ec-8805-5ebe3f9b621e 49999-455 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride TABLET, COATED ORAL 20111207 NDA NDA021085 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49999-458_c2c69a91-1be5-4ada-a0b9-e40e7fc1c474 49999-458 HUMAN PRESCRIPTION DRUG Evista Raloxifene hydrochloride TABLET ORAL 20120307 NDA NDA020815 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 49999-467_02e0c3d4-29da-49b6-a57b-8bc52b005de5 49999-467 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20120305 NDA NDA020702 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49999-468_02e0c3d4-29da-49b6-a57b-8bc52b005de5 49999-468 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20120305 NDA NDA020702 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49999-469_d8798e6a-bfd2-4d88-897d-1f055d7d2245 49999-469 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20120327 ANDA ANDA077321 Lake Erie Medical Quality Care Products LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49999-471_aeed5777-58ca-40ca-a5f3-ddc2e0dc8611 49999-471 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Lake Erie Medical DBA Quality Care Products LLC LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49999-475_390144bf-d618-46b1-bd9a-928eec27c9a6 49999-475 HUMAN PRESCRIPTION DRUG Niaspan ER Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110207 NDA NDA020381 Lake Erie Medical DBA Quality Care Products LLC NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 49999-476_a32ada5b-8360-4e8d-8d78-2aca82a313ac 49999-476 HUMAN PRESCRIPTION DRUG Nifedipine Extended Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20070622 ANDA ANDA077899 Lake Erie Medical DBA Quality Care Products LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49999-478_b1271f57-b0e9-4e16-aa7b-a72710710d18 49999-478 HUMAN PRESCRIPTION DRUG Norvasc amlodipine besylate TABLET ORAL 20111122 NDA NDA019787 Lake Erie Medical & Surgical Supplies DBA Quality Care Products LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 49999-480_e746e443-89b0-45f8-b018-7dec45285611 49999-480 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole CAPSULE, DELAYED RELEASE ORAL 19950510 NDA NDA020406 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 49999-481_38f3b2a1-04dd-44be-ae2a-4318806a4429 49999-481 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20111117 NDA NDA020987 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 49999-483_1bf1ee83-3ece-4cee-a0d7-cfd949724f16 49999-483 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 19920201 NDA NDA019962 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49999-486_15eaad48-7fb2-462c-a00e-5e4615bf4ddc 49999-486 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 20120320 NDA NDA020487 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 49999-487_6dfd1117-3b04-45e8-a31d-22aba7d856c6 49999-487 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20120319 NDA NDA021445 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] 49999-504_c4867119-e8e7-4b5f-9500-e97045ad0ec7 49999-504 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063181 Lake Erie Medical DBA Quality Care Products LLC MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 49999-505_60e3437b-6727-4d3d-ba15-c7b4c897bde4 49999-505 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20101008 ANDA ANDA063065 Lake Erie Medical DBA Quality Care Products LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 49999-517_688a43cc-84c2-47e6-83bf-73a343706ca5 49999-517 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120815 ANDA ANDA040876 Lake Erie Medical DBA Quality Care Products PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 49999-520_4efec3eb-da83-40d6-9a6f-8cf9ae2b05d4 49999-520 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20120307 ANDA ANDA077253 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 49999-521_d500f8c3-d133-444d-817b-596d08bbe99e 49999-521 HUMAN PRESCRIPTION DRUG BACTROBAN mupirocin calcium CREAM TOPICAL 20120328 NDA NDA050746 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MUPIROCIN CALCIUM 21.5 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 49999-533_5c5a1608-4946-4075-bef6-39364a3d41e2 49999-533 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, FILM COATED ORAL 20120321 NDA NDA020829 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 49999-538_1625b279-ba99-41ca-99a9-bd53284c0784 49999-538 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20120208 ANDA ANDA073553 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 49999-539_0e0b38f6-23b7-4252-bf6a-367f32a5a1d4 49999-539 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100917 ANDA ANDA075350 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49999-540_85967055-9c54-403a-841f-dcc10509e62a 49999-540 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20101104 ANDA ANDA075350 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49999-543_648903ce-1832-4d04-a645-01bdff20788f 49999-543 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20111115 NDA NDA021283 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49999-552_a4bcfa54-4c80-4642-8315-7642a6dd9de5 49999-552 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 Lake Erie Medical DBA Quality Care Products LLC BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 49999-555_feea7454-bb69-41b1-bbec-e3b8052d279e 49999-555 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20120323 ANDA ANDA070176 Lake Erie Medical DBA Quality Care Products LLC PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49999-568_0c18131e-93a1-4cac-9d6b-389678f98350 49999-568 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20111105 ANDA ANDA078428 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49999-574_ac6f45e2-7819-4b73-b47a-e7582187a787 49999-574 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20061212 ANDA ANDA040621 Lake Erie Medical DBA Quality Care Products LLC PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49999-575_e1403631-a753-4cc8-8cf0-1e6aa7cbdcdd 49999-575 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20040115 ANDA ANDA076670 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 49999-577_8c567740-6130-4c8f-b9cd-e501d6951733 49999-577 HUMAN PRESCRIPTION DRUG COREG carvedilol TABLET, FILM COATED ORAL 20111121 NDA NDA020297 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 49999-584_e317888f-195e-4d45-9802-e99327d2127a 49999-584 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride TABLET ORAL 20110420 ANDA ANDA076280 Lake Erie Medical DBA Quality Care Products LLC TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 49999-588_0b4982fe-223c-4a24-8e77-f75591eea8b6 49999-588 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 20101117 ANDA ANDA076604 Lake Erie Medical DBA Quality Care Products LLC HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 49999-593_7eea4fee-9fff-43bb-8c5b-e88c4b8e3b05 49999-593 HUMAN PRESCRIPTION DRUG Diclofenac Potassium diclofenac potassium TABLET, FILM COATED ORAL 20111205 ANDA ANDA075463 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-598_56d26f2d-776e-4000-97db-62b07392fa51 49999-598 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20120217 NDA NDA021436 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] 49999-599_97898fbd-01ba-4874-9c02-856e387ad2eb 49999-599 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110525 NDA NDA020699 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-600_1e5dbc32-1884-4fbc-9e30-407879487fdf 49999-600 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20111214 NDA NDA021323 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-602_0deca45f-5003-40e0-b464-ea0905de58ce 49999-602 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20120416 NDA NDA020639 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 49999-603_0deca45f-5003-40e0-b464-ea0905de58ce 49999-603 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20120416 NDA NDA020639 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 49999-606_36328214-3213-4596-9a86-06dd931bcb1a 49999-606 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20120330 NDA NDA020592 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 49999-607_1656244d-1e72-4ca0-9515-7800f99545f2 49999-607 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100519 ANDA ANDA074584 Lake Erie Medical DBA Quality Care Products LLC BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 49999-608_3162fb28-32ad-4c10-a7c5-47f1e474fd1a 49999-608 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040409 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49999-609_b7f796ed-4ad9-4f38-993c-a9480af5eef5 49999-609 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111109 ANDA ANDA040405 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 49999-610_b55c729d-06b6-43cd-bb5a-f496eebf1f2a 49999-610 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate SOLUTION ORAL 20061001 OTC MONOGRAPH FINAL part341 Lake Erie Medical DBA Quality Care Products LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 49999-611_116c17bf-c6e2-4cff-932f-f7f1037594ac 49999-611 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE ORAL 20101012 ANDA ANDA075576 Lake Erie Medical DBA Quality Care Products LLC OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 49999-614_923ee0cd-ec1d-44c1-a4dc-eb425a30ff78 49999-614 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20070129 NDA NDA021433 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLUTICASONE PROPIONATE 110 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49999-618_e8eaffb2-9e64-4c06-8b6d-53af10803849 49999-618 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20110714 NDA NDA021427 Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-619_e8eaffb2-9e64-4c06-8b6d-53af10803849 49999-619 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20110714 NDA NDA021427 Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-620_e1e6efcf-60ff-42af-baa5-64d65862c210 49999-620 HUMAN PRESCRIPTION DRUG Geodon Ziprasidone Hydrochloride Monohydrate CAPSULE ORAL 20101105 NDA NDA020825 Lake Erie Medical DBA Quality Care Products LLC ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 49999-621_5c14a19c-0519-4855-9a58-59b686bd0eb8 49999-621 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20120327 NDA NDA020825 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 49999-627_1e5dbc32-1884-4fbc-9e30-407879487fdf 49999-627 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20111214 NDA NDA021323 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-629_2a4c3543-cfd3-4ab3-89a3-6c19704edb0e 49999-629 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Lake Erie Medical DBA Quality Care Products LLC MIRTAZAPINE 15 mg/1 49999-630_63bc3c6d-7546-44c5-8d85-f4ec0f6482d5 49999-630 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20100828 ANDA ANDA076119 Lake Erie Medical DBA Quality Care Products LLC MIRTAZAPINE 30 mg/1 49999-631_144c39c7-180c-4134-a8a2-116da3f926b7 49999-631 HUMAN PRESCRIPTION DRUG PAROXETINE Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Lake Erie Medical DBA Quality Care Products LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-632_144c39c7-180c-4134-a8a2-116da3f926b7 49999-632 HUMAN PRESCRIPTION DRUG PAROXETINE Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20111108 ANDA ANDA077584 Lake Erie Medical DBA Quality Care Products LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-636_5f48f6d9-92c0-4437-b354-5cbe1ac225cf 49999-636 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine CAPSULE ORAL 20100713 NDA NDA021411 Lake Erie Medical DBA Quality Care Products LLC ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 49999-646_fce94d1c-69de-4bfa-854e-d08a2de7327e 49999-646 HUMAN PRESCRIPTION DRUG CICLOPIROX OLAMINE CICLOPIROX OLAMINE CREAM TOPICAL 20101103 ANDA ANDA077364 Lake Erie Medical DBA Quality Care Products LLC CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 49999-654_9b5e623c-e23c-47d3-99f4-49c6b53797a5 49999-654 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20111122 ANDA ANDA077289 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-656_da108c5b-931a-459f-ac67-ccd8036ce357 49999-656 HUMAN PRESCRIPTION DRUG SULINDAC SULINDAC TABLET ORAL 20100623 ANDA ANDA071795 Lake Erie Medical DBA Quality Care Products LLC SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-691_344a73f4-db2c-455b-bd0a-138db77425f8 49999-691 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20101115 ANDA ANDA072825 Lake Erie Medical DBA Quality Care Products LLC BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 49999-692_7d516a2a-4b48-4812-8719-271b2bb31e67 49999-692 HUMAN PRESCRIPTION DRUG GABITRIL tiagabine hydrochloride TABLET ORAL 20111115 NDA NDA020646 Lake Erie Medical & Surgial Supply DBA Quality Care Products LLC TIAGABINE HYDROCHLORIDE 4 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49999-693_d659d48a-3966-4fff-8353-ccebe3fd8b45 49999-693 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20111209 ANDA ANDA090485 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 49999-699_55507c53-4bd0-4f5e-bdbc-ffcf8d8f9180 49999-699 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20050121 ANDA ANDA076673 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 49999-701_ef5825f3-e62e-4c2d-ab98-2d7458755c69 49999-701 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 49999-711_ca9278a5-e5ea-4109-85ba-7698cbec3deb 49999-711 HUMAN OTC DRUG Senna Plus Senna Plus TABLET ORAL 20120215 OTC MONOGRAPH NOT FINAL part334 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SENNOSIDES A AND B 8.6 mg/1 49999-737_7b45a698-2ceb-4aa8-9421-a71e513b940c 49999-737 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20110718 NDA NDA021476 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ESZOPICLONE 3 mg/1 CIV 49999-739_36328214-3213-4596-9a86-06dd931bcb1a 49999-739 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20120330 NDA NDA020592 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 49999-755_38f3b2a1-04dd-44be-ae2a-4318806a4429 49999-755 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20111117 NDA NDA020987 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 49999-763_b14add9a-30ab-4cf1-b411-4f46d4ea09e7 49999-763 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20111213 NDA NDA021774 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 49999-764_8db8978c-7eaa-4b7f-b6f2-026922a83877 49999-764 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET ORAL 20111110 NDA NDA021774 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 49999-766_a8a627b8-9e4b-4d02-8d9f-6c60a13b7e6b 49999-766 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20111215 ANDA ANDA065228 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 49999-767_48cd0eaf-72bf-479d-bb28-b9669c6f7375 49999-767 HUMAN PRESCRIPTION DRUG Propoxyphene Napsylate and Acetaminophen Propoxyphene Napsylate and Acetaminophen TABLET, FILM COATED ORAL 20110125 ANDA ANDA074119 Lake Erie Medical DBA Quality Care Products ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 650; 100 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 49999-771_c66a14ed-6401-4952-8733-9b4929771ba1 49999-771 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET ORAL 20091209 ANDA ANDA076502 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 49999-772_78fe281d-6609-49be-b78b-38d5bc6fb912 49999-772 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20100607 ANDA ANDA020872 Lake Erie Medical DBA Quality Care Products LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 49999-774_83884fd4-6a9b-4df5-ae97-5d59a097f766 49999-774 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA021515 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49999-778_7b45a698-2ceb-4aa8-9421-a71e513b940c 49999-778 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20110718 NDA NDA021476 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ESZOPICLONE 1 mg/1 CIV 49999-779_b2535647-00a9-4342-aa15-235bbc2a3fec 49999-779 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20111118 NDA NDA021476 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ESZOPICLONE 2 mg/1 CIV 49999-784_319760b6-5234-4587-92b0-967e3627eb78 49999-784 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20111104 ANDA ANDA077662 Lake Erie Medica & Surgical Supply DBA Quality Care Products LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49999-786_e14b891a-3085-4361-a0a9-5e38eae97274 49999-786 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20111221 ANDA ANDA065404 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 49999-789_9b5e623c-e23c-47d3-99f4-49c6b53797a5 49999-789 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20111122 ANDA ANDA077289 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-791_681e814e-2608-45fa-a9e5-c766d60ac78c 49999-791 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120202 ANDA ANDA071611 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 49999-797_b9eca33f-5099-453a-bb87-358310be1446 49999-797 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Lake Erie Medical DBA Quality Care Products LLC LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 49999-799_6624ed11-53f2-4232-8598-3e13ed8790f2 49999-799 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20101206 ANDA ANDA077662 Lake Erie Medical & Surgical S6758upply DBA Quality Care Products LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 49999-800_7a72b026-532a-4744-a8ae-f06267d6c1a4 49999-800 HUMAN PRESCRIPTION DRUG Lactulose lactulose SOLUTION ORAL 20040419 ANDA ANDA074623 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 49999-804_23f25305-e4dc-489b-bbe8-231129e45b73 49999-804 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20120403 NDA NDA021487 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 49999-805_3887fd61-af45-4fc5-902f-8bb575351527 49999-805 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20111117 ANDA ANDA072926 Lake Erie Medical DBA Quality Care Products LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 49999-812_a62ed0d3-f41c-4b00-b141-70dd4eb44fdf 49999-812 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20101116 ANDA ANDA074253 Lake Erie Medical DBA Quality Care Products LLC BUSPIRONE HYDROCHLORIDE 10 mg/1 49999-815_1539e354-7334-4e81-a18e-b4233e00c85c 49999-815 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20120222 NDA NDA021286 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49999-816_56d26f2d-776e-4000-97db-62b07392fa51 49999-816 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20120217 NDA NDA021436 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] 49999-817_28f0dea2-4ea7-4d31-a4a7-907e412e11e8 49999-817 HUMAN PRESCRIPTION DRUG Abilify Aripiprazole TABLET ORAL 20100603 NDA NDA021436 Lake Erie Medical DBA Quality Care Products LLC ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] 49999-818_d674cdc7-ba5b-4509-a365-baae3cc6ea02 49999-818 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20110728 NDA NDA021436 Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] 49999-819_2eb360bb-9b05-4fcf-b368-48283c3a9fca 49999-819 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20120217 NDA NDA021077 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 250; 50 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49999-823_7407f509-bcd1-405a-b8da-8a09ef215f48 49999-823 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET ORAL 20090723 ANDA ANDA076486 Lake Erie Medical DBA Quality Care Products LLC ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49999-828_f261b7f8-57d6-4113-a46e-cc4ef18b2930 49999-828 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-830_feb667f9-3527-4ab5-bdd9-a5e9057e875a 49999-830 HUMAN PRESCRIPTION DRUG ENDOCET Oxycodone and Acetaminophen TABLET ORAL 20120302 ANDA ANDA040341 Lake Erie Medical & Surgical Supply DBA Quality Care Produtcs LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-831_306cccd8-80a3-4d67-95d3-e1d810ae915b 49999-831 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20111209 ANDA ANDA076709 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FENTANYL 2.5 mg/72h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-832_306cccd8-80a3-4d67-95d3-e1d810ae915b 49999-832 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20111209 ANDA ANDA076709 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FENTANYL 5 mg/72h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-833_2e8cec25-4507-41cf-ae44-aa6c158d5d11 49999-833 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20111209 ANDA ANDA076709 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FENTANYL 7.5 mg/72h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-834_306cccd8-80a3-4d67-95d3-e1d810ae915b 49999-834 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20111209 ANDA ANDA076709 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FENTANYL 10 mg/72h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-835_3854da86-e19c-40da-8a70-6ef6289c3671 49999-835 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 20111129 ANDA ANDA078273 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-835_6f6aebe6-5ea6-4294-afce-e620b9b642a0 49999-835 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 20111129 ANDA ANDA078273 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-836_05956f86-2ea7-4ffb-959e-90f681c62943 49999-836 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20100426 ANDA ANDA076855 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-839_b4e3d741-8f72-4cce-be1e-50408db9b382 49999-839 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20120206 ANDA ANDA040517 Lake Erie Medical DBA Quality Care Products LLC METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-839_d07edc62-5515-4b83-b4c4-c5dc6c95aaf2 49999-839 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20101011 ANDA ANDA040517 Lake Erie Medical DBA Quality Care Products LLC METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-844_d6e66612-57de-4712-a85d-b3a03e5b9003 49999-844 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 20100915 ANDA ANDA040220 Lake Erie Medical DBA Quality Care Products LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 49999-845_6eedbed7-e74d-4eeb-8362-5f8272128217 49999-845 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, EXTENDED RELEASE ORAL; ORAL 20100917 ANDA ANDA075295 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-845_91d3b2d6-f799-4124-afb4-589137671968 49999-845 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, EXTENDED RELEASE ORAL; ORAL 20100917 ANDA ANDA075295 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-846_76068868-db8a-4252-a422-cb76087a47a7 49999-846 HUMAN PRESCRIPTION DRUG Morphine Sulfate ER Morphine Sulfate TABLET ORAL 20100812 ANDA ANDA076438 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-846_faa7d020-60db-4c79-8fca-2887e48f3fe3 49999-846 HUMAN PRESCRIPTION DRUG Morphine SulfateER ER Morphine Sulfate TABLET ORAL 20100407 ANDA ANDA076438 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-847_98e7839d-d75f-4a8b-9ecd-09a04af593ad 49999-847 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET ORAL 20100828 ANDA ANDA076438 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-847_e32d0192-7da9-4563-869c-ab835b2d4dc2 49999-847 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET ORAL 20100819 ANDA ANDA076438 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-848_dadb8114-f39a-48eb-bacd-238e52a3357a 49999-848 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20120319 NDA NDA022207 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-849_df88b967-cf31-4714-a180-75bbe8d9d0b5 49999-849 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20111213 NDA NDA022195 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-850_8e2e4990-5938-4513-988d-c395e32deb76 49999-850 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20120214 ANDA ANDA076758 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-851_2d2d5dbd-7da0-4085-bbbf-6a72b0fe1c73 49999-851 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20100819 ANDA ANDA076758 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-852_0f3c9c08-ae84-4ba6-b671-b40b63dc7944 49999-852 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20100610 ANDA ANDA087463 Lake Erie Medical DBA Quality Care products LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-853_a800088c-4be9-4345-bf1c-a7f2d198795c 49999-853 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20111115 ANDA ANDA040535 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-854_803b7714-58f9-40ff-afac-9a016d202293 49999-854 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20110201 ANDA ANDA040545 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-855_a800088c-4be9-4345-bf1c-a7f2d198795c 49999-855 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20111115 ANDA ANDA040371 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 650; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-856_12f20ab6-a011-4785-a518-b8ced96410e6 49999-856 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19951201 NDA NDA022272 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-857_28987a0c-43ef-481a-afc8-c6af282200ef 49999-857 HUMAN PRESCRIPTION DRUG Oxycontin Oxycodone Hydrochloride TABLET ORAL 20100828 NDA NDA020553 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-860_ec057887-c4e1-4907-81f6-257eaf07e8a6 49999-860 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20111107 NDA AUTHORIZED GENERIC NDA019839 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-861_ec057887-c4e1-4907-81f6-257eaf07e8a6 49999-861 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20111107 NDA AUTHORIZED GENERIC NDA019839 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-868_84ffd3d9-ab05-454a-b76a-cb916678e357 49999-868 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20111107 ANDA ANDA077918 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-869_1af3bdaa-a50e-4673-876a-f3ac1f1c91ce 49999-869 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100917 ANDA ANDA077927 Lake Erie Medical DBA Quality Care Products LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-870_cd98b981-61d2-4870-8eca-82f92bc9d693 49999-870 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20070215 ANDA ANDA077321 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49999-871_04d94da4-1e6c-4d3d-9d92-6a11027558b0 49999-871 HUMAN PRESCRIPTION DRUG Altace Ramipril CAPSULE ORAL 20100524 NDA NDA019901 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 49999-872_8c567740-6130-4c8f-b9cd-e501d6951733 49999-872 HUMAN PRESCRIPTION DRUG COREG carvedilol TABLET, FILM COATED ORAL 20111121 NDA NDA020297 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 49999-873_53a2af25-fd90-46f0-b0c1-60399e543ff2 49999-873 HUMAN PRESCRIPTION DRUG Crestor Rosuvastatin calcium TABLET, COATED ORAL 20101109 NDA NDA021366 Lake Erie Medical DBA Quality Care Products LLC ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49999-877_13a8217d-9554-4885-8ec6-1498f82c5734 49999-877 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20120228 NDA NDA021283 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49999-878_13a8217d-9554-4885-8ec6-1498f82c5734 49999-878 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20120228 NDA NDA021283 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49999-879_c689c7c6-4d37-4b5e-919f-49da9125e4b5 49999-879 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20111115 NDA NDA020818 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 49999-880_39a06fb8-9987-4cb8-8fd3-883e8000ec6a 49999-880 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120228 NDA NDA020818 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49999-881_a1cc795d-6be7-44d3-9e66-a2a6ca6c0cf5 49999-881 HUMAN PRESCRIPTION DRUG Flomax Flomax CAPSULE ORAL 20100513 NDA NDA020579 Lake Erie Medical DBA Quality Care Products TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 49999-882_02e0c3d4-29da-49b6-a57b-8bc52b005de5 49999-882 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20120305 NDA NDA020702 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49999-884_5c5a1608-4946-4075-bef6-39364a3d41e2 49999-884 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 20120321 NDA NDA020830 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 49999-885_3a198a09-0cf3-449c-9c64-8530cb29b8a9 49999-885 HUMAN PRESCRIPTION DRUG Tricor Fenofibrate TABLET ORAL 20120320 NDA NDA021656 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 49999-886_bb51375f-7929-420f-8209-630916f85324 49999-886 HUMAN PRESCRIPTION DRUG FLUOXETINE fluoxetine hydrochloride CAPSULE ORAL 20111107 ANDA ANDA076922 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 49999-889_1f9cdd41-432d-49b9-b8f6-0929ac017b42 49999-889 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111122 ANDA ANDA077691 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49999-895_0488a4b1-3f25-4625-9105-a951820f31f8 49999-895 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20110210 NDA NDA021724 Lake Erie Medical DBA Quality Care Products LLC PREGABALIN 75 mg/1 CIV 49999-896_f7825d82-44f7-40ae-a394-9a5e14e7e459 49999-896 HUMAN PRESCRIPTION DRUG Ultram ER Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA021692 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 49999-897_114c1bda-ef65-40f2-8fb5-b68803281649 49999-897 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 20110203 ANDA ANDA075227 Lake Erie Medical DBA Quality Care Products LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 49999-899_3b2ba1b2-2b12-4d52-befc-0f08493a941e 49999-899 HUMAN PRESCRIPTION DRUG Oxycodone Hydchloride Oxycodone Hydchloride TABLET ORAL 20111220 ANDA ANDA091393 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-904_f17fc554-5558-4b2a-9bee-72aae30de120 49999-904 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20101115 ANDA ANDA065136 Lake Erie Medical DBA Quality Care Products LLC CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 49999-905_0ec72d6f-10c9-4e35-b400-22be3a1e7098 49999-905 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20120206 NDA NDA021724 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PREGABALIN 100 mg/1 49999-906_18314e7c-8ded-416f-acff-6c7d8d519a11 49999-906 HUMAN PRESCRIPTION DRUG Lyrica Pregabalin CAPSULE ORAL 20100927 NDA NDA021724 Lake Erie Medical DBA Quality Care Products LLC PREGABALIN 200 mg/1 CV 49999-907_9cbbbdf3-5e8a-4077-a42d-f1c4dd3d17fb 49999-907 HUMAN PRESCRIPTION DRUG Proventil HFA Albuterol Sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20011001 NDA NDA020503 Lake Erie Medical DBA Quality Care Products LLC ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 49999-908_4c7bf665-30aa-4db8-a720-2bad24e02a06 49999-908 HUMAN PRESCRIPTION DRUG PROAIR HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20120321 NDA NDA021457 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 49999-909_4fbc1c76-86c7-420f-8b3c-368012821845 49999-909 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20100824 ANDA ANDA086009 Lake Erie Medical DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 49999-913_6ed90754-6395-4126-a6c5-c1c523739211 49999-913 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071525 Lake Erie Medical DBA Quality Care Products LLC TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 49999-914_dd7c00d2-750d-4eef-8db2-d1d830358d09 49999-914 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 19961111 ANDA ANDA070848 Lake Erie Medical DBA Quality Care Products LLC SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 49999-915_79a25c8f-4c75-47e3-83a2-51edee8846fd 49999-915 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20111205 ANDA ANDA073555 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 49999-916_0c4baa20-6def-4135-b496-3f2440c549a8 49999-916 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 20120316 ANDA ANDA074377 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MEXILETINE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] 49999-918_7b23fd73-5a27-47e1-8216-012cd643f3bb 49999-918 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49999-924_9ef95d87-ea19-4a81-adbb-67c679646dc2 49999-924 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060927 ANDA ANDA077912 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49999-931_1d49a704-4cec-4f82-a326-24aef9d01f88 49999-931 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20110415 ANDA ANDA078616 Lake Erie Medical DBA Quality Care Products LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 49999-932_be58a296-dc68-480e-93f7-90868fc0941b 49999-932 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20111107 ANDA ANDA078616 Lake Erie Medical DBA Quality Care Products LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 49999-936_6277f688-02e3-419b-b281-8c51981170f9 49999-936 HUMAN PRESCRIPTION DRUG CellCept Mycophenolate Mofetil CAPSULE ORAL 20111129 NDA NDA050722 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 49999-937_a87232f9-e3d6-4afa-96d4-9d1d45e11641 49999-937 HUMAN PRESCRIPTION DRUG CellCept Mycophenolate Mofetil TABLET, FILM COATED ORAL 19970619 NDA NDA050723 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 49999-938_8c567740-6130-4c8f-b9cd-e501d6951733 49999-938 HUMAN PRESCRIPTION DRUG COREG carvedilol TABLET, FILM COATED ORAL 20111121 NDA NDA020297 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 49999-941_475b65ab-1e44-46d0-8294-0486190cc363 49999-941 HUMAN PRESCRIPTION DRUG Depakote Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111114 NDA NDA018723 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 49999-943_39a06fb8-9987-4cb8-8fd3-883e8000ec6a 49999-943 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120228 NDA NDA020818 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 49999-949_998c886d-bc5c-4d5e-a30f-58398d776c84 49999-949 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20111108 NDA NDA021724 Lake Erie Medical & Surgical Supply, DBA Quality Care Products, LLC PREGABALIN 50 mg/1 CIV 49999-951_e8432823-6d78-461e-b5e2-64552809e122 49999-951 HUMAN PRESCRIPTION DRUG Seroquel Quetiapine Fumarate TABLET, FILM COATED ORAL 20100708 NDA NDA020639 Lake Erie Medical DBA Quality Care Products LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 49999-952_5c5a1608-4946-4075-bef6-39364a3d41e2 49999-952 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 20120321 NDA NDA020830 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 49999-957_74e37778-f545-4590-bc96-07fdb5d6ff9c 49999-957 HUMAN PRESCRIPTION DRUG Vytorin Ezetimibe Simvastin TABLET ORAL 20100927 NDA NDA021687 Lake Erie Medical DBA Quality Care Products LLC EZETIMIBE; SIMVASTATIN 10; 20 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49999-958_434bf376-4331-444a-a925-9f1e8bff3c36 49999-958 HUMAN PRESCRIPTION DRUG Vytorin Ezetimibe/Simvastin TABLET ORAL 20100827 NDA NDA021687 Lake Erie Medical DBA Quality Care Products LLC EZETIMIBE; SIMVASTATIN 10; 40 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 49999-963_1243f640-fbe5-45a6-8ee0-b4bdf3ebaa9d 49999-963 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20101004 ANDA ANDA040517 Lake Erie Medical DBA Quality Care Products LLC METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-963_f9b0a37f-4062-4c94-a3d5-69c5cb768ec6 49999-963 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20100915 ANDA ANDA040517 Lake Erie Medical DBA Quality Care Products LLC METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 49999-965_26772b47-c346-4390-a749-148146f4be10 49999-965 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090825 ANDA ANDA079094 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 49999-969_1156b2ec-4271-40f4-b1da-fd400778cb2b 49999-969 HUMAN PRESCRIPTION DRUG ASACOL mesalamine TABLET, DELAYED RELEASE ORAL 20120323 NDA NDA019651 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 49999-982_983cdbf8-d9d3-45f9-a6ef-0898b86c059c 49999-982 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20120312 ANDA ANDA077570 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49999-984_2eb360bb-9b05-4fcf-b368-48283c3a9fca 49999-984 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20120217 NDA NDA021077 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 100; 50 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49999-985_2eb360bb-9b05-4fcf-b368-48283c3a9fca 49999-985 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20120217 NDA NDA021077 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 500; 50 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 49999-987_4328ede8-499a-446b-9d76-8809a2258eb2 49999-987 HUMAN PRESCRIPTION DRUG ARTHROTEC diclofenac sodium and misoprostol TABLET, FILM COATED ORAL 20120223 NDA NDA020607 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 49999-992_a1d421a7-73ea-4bb6-99f5-b4529d360daf 49999-992 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20120227 NDA NDA021366 Lake Erie Medical & Surgucal Supply DBA Quality Care Products LLC ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50001-111_347f2743-075b-46c7-82ad-19e4d5ba42b3 50001-111 HUMAN OTC DRUG Level Anticavity SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20091230 OTC MONOGRAPH NOT FINAL part355 Level Oral Care, LLC SODIUM MONOFLUOROPHOSPHATE 76 g/100g 50001-121_bec980cf-92d7-4c5c-bce8-1da7113cfc08 50001-121 HUMAN OTC DRUG LEVEL WINTERMINT FIVE WHITENING FORMULA ANTICAVITY SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100816 OTC MONOGRAPH FINAL part356 LEVEL ORAL CARE, LLC SODIUM MONOFLUOROPHOSPHATE .76 g/100g 50001-131_acbdcd4b-ada1-4f89-9046-428b73844128 50001-131 HUMAN OTC DRUG LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100812 OTC MONOGRAPH FINAL part356 LEVEL ORAL CARE, LLC POTASSIUM NITRATE; SODIUM MONOFLUOROPHOSPHATE 5; .76 g/100g; g/100g 50006-100_916b2dde-356f-4b1f-b117-5ceeb18c3d75 50006-100 HUMAN OTC DRUG Nex Iodio P2 Povidone-Iodine SPONGE TOPICAL 20091127 OTC MONOGRAPH NOT FINAL part333 Nex Medical S.A.S. di Villa Annamaria & C. POVIDONE-IODINE 5 mL/100mL 50006-200_fd99a465-b176-4e3a-91d9-c6d410df986f 50006-200 HUMAN OTC DRUG Nex Iodio P2 Povidone-Iodine SPONGE TOPICAL 20091127 OTC MONOGRAPH NOT FINAL part333 Nex Medical S.A.S. di Villa Annamaria & C. POVIDONE-IODINE 10 mL/100mL 50006-300_22222bd1-7aef-4cce-856a-ef4a6a450bf8 50006-300 HUMAN OTC DRUG Triclonex T2 Triclosan SPONGE TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part333 Nex Medical S.A.S. di Villa Annamaria & C. TRICLOSAN .5 mL/100mL 50007-1000_062f4b65-ebd4-4dd5-a3ba-3e7c1995c8ae 50007-1000 HUMAN OTC DRUG Lactovit Original Roll-On Antiperspirant Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20091216 OTC MONOGRAPH FINAL part350 Antonio Puig, S.A. ALUMINUM CHLOROHYDRATE 15 mL/100mL 50007-2000_0a4436d5-8d69-4a97-bec2-16b378a9334c 50007-2000 HUMAN OTC DRUG Lactovit Sensitive Skin Roll-On Antiperspirant Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20091216 OTC MONOGRAPH FINAL part350 Antonio Puig, S.A. ALUMINUM CHLOROHYDRATE 10 mL/100mL 50007-3000_bb3c62cb-a3de-4296-a8fc-129da58170eb 50007-3000 HUMAN OTC DRUG Lactovit Men Roll-On Antiperspirant Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20091216 OTC MONOGRAPH FINAL part350 Antonio Puig, S.A. ALUMINUM CHLOROHYDRATE 15 mL/100mL 50014-100_079e3129-90c7-4447-bfc8-b233a1262c17 50014-100 HUMAN OTC DRUG Antibacterial Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 China Shaanxi Richbond Industrial Imp. & Exp. Ltd. BENZALKONIUM CHLORIDE .1 1/1 50017-020_b972fec1-ac0a-45fd-8a73-ada973845c25 50017-020 HUMAN OTC DRUG Foot Saver Antiperspirant GEL TOPICAL 20130328 OTC MONOGRAPH FINAL part350 Neat Feat Products Limited ALUMINUM CHLOROHYDRATE 13.5 g/60mL 50017-022_4b17b0ca-e73c-46e6-9f0c-da97a5028a7c 50017-022 HUMAN OTC DRUG Bodysaver skin protectant CREAM TOPICAL 20130407 OTC MONOGRAPH FINAL part347 Neat Feat Products Limited ZINC ACETATE .15 g/75g 50017-023_f4244448-e528-42f7-bb11-4790af8f74e3 50017-023 HUMAN OTC DRUG Action Cream skin protectant CREAM TOPICAL 20130407 OTC MONOGRAPH FINAL part347 Neat Feat Products Limited ZINC ACETATE .15 g/75g 50017-024_a6b2aa68-6158-4c14-8250-3f254c93a8be 50017-024 HUMAN OTC DRUG Face Saver Gel Antiperspirant GEL TOPICAL 20130328 OTC MONOGRAPH FINAL part350 Neat Feat Products Limited ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 8.75 g/g 50017-025_b7359404-7df9-4830-b298-7acf5d630b02 50017-025 HUMAN OTC DRUG Hand Saver Antiperspirant LOTION TOPICAL 20130328 OTC MONOGRAPH FINAL part350 Neat Feat Products Limited ALUMINUM CHLOROHYDRATE 11 g/50g 50017-026_2dba96ab-82e8-46a0-a4f3-64fb3a5084f6 50017-026 HUMAN OTC DRUG BabyB BabySaver skin protectant CREAM TOPICAL 20130407 OTC MONOGRAPH FINAL part347 Neat Feat Products Limited ZINC ACETATE 1 g/50g 50017-027_560cd43e-d36d-4db5-b0d2-65c562436ae0 50017-027 HUMAN OTC DRUG BabyB BabySaver skin protectant CREAM TOPICAL 20130407 OTC MONOGRAPH FINAL part347 Neat Feat Products Limited ZINC ACETATE 15 g/150g 50021-016_4ce56875-4b80-471f-8124-0c24d65329b8 50021-016 HUMAN OTC DRUG Sunzone Family SPF 15 Broad Spectrum Octinoxate and Avobenzone LOTION TOPICAL 20121114 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. AVOBENZONE; OCTINOXATE 1.18; 2.35 g/235g; g/235g 50021-061_a3e1687e-55ea-46bd-888b-76ae21b21dbb 50021-061 HUMAN OTC DRUG SUNZONE KIDS SPF 60 Broad Spectrum Octinoxate, Octocrylene, Octisalate, Oxybenzone, Avobenzone and Homosalate. AEROSOL, SPRAY TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.65; 18.6; 7.75; 7.75; 7.75; 9.3 g/155g; g/155g; g/155g; g/155g; g/155g; g/155g 50021-062_fb7fc079-c9bc-4469-b5b2-f3fc32876844 50021-062 HUMAN OTC DRUG SUNZONE FAMILY SPF 60 Broad Spectrum Octinoxate, Octocrylene, Octisalate, Oxybenzone, Avobenzone and Homosalate. AEROSOL, SPRAY TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.65; 18.6; 7.75; 7.75; 7.75; 9.3 g/155g; g/155g; g/155g; g/155g; g/155g; g/155g 50021-065_da941e21-1a79-11e0-ac64-0800200c9a66 50021-065 HUMAN OTC DRUG ZYTEC Germ Buster Hand Sanitizer Ethanol GEL TOPICAL 20110128 OTC MONOGRAPH NOT FINAL part356 Empack ETHANOL 143 g/238g 50021-080_da941e20-1a79-11e0-ac64-0800200c9a66 50021-080 HUMAN OTC DRUG ZYTEC GERM BUSTER HAND SANITIZER ETHANOL AEROSOL, SPRAY TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part356 Empack ETHANOL 224 g/400g 50021-144_38676290-f5ea-470f-bf1c-7c4fce8b059d 50021-144 HUMAN OTC DRUG SUNZONE FAMILY SUNSCREEN SPF 30 Broad Spectrum Octinoxate, Octocrylene, Octisalate, Oxybenzone, Avobenzone and Homosalate. AEROSOL, SPRAY TOPICAL 20121108 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.59; 2.4; 11.48; 7.65; 11.48; 6.12 g/153g; g/153g; g/153g; g/153g; g/153g; g/153g 50021-151_84c7e96a-ba3d-4eaa-bce0-eb882e5bf6c7 50021-151 HUMAN OTC DRUG SunZone Kids SPF 45 Broad Spectrum Octocrylene, Octisalate, Homosalate, Avobenzone and Oxybenzone AEROSOL, SPRAY TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 7.5; 3; 7.5 g/150g; g/150g; g/150g; g/150g; g/150g 50021-152_2a410231-4b49-4f62-aa30-d5ea47e6e37c 50021-152 HUMAN OTC DRUG SunZone Family SPF 45 Broad Spectrum Octocrylene, Octisalate, Homosalate, Avobenzone and Oxybenzone AEROSOL, SPRAY TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 7.5; 3; 7.5 g/150g; g/150g; g/150g; g/150g; g/150g 50021-234_89797ab4-0766-4f9b-b313-e59b02004923 50021-234 HUMAN OTC DRUG SunZone SPF-60 Broad Spectrum Avobenzone and Octinoxate LOTION TOPICAL 20121113 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. AVOBENZONE; OCTINOXATE 7.02; 9.36 g/234g; g/234g 50021-235_84b3de68-9b88-46d9-9234-a13925f2ec56 50021-235 HUMAN OTC DRUG SunZone Family SPF 30 Broad Spectrum Octinoxate and Avobenzone LOTION TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc AVOBENZONE; OCTINOXATE 1.76; 4.7 g/235g; g/235g 50021-236_104b8f3e-77e1-4967-aa67-246613a39410 50021-236 HUMAN OTC DRUG SunZone Sport SPF 30 Sunscreen Broad Spectrum Octinoxate and Avobenzone LOTION TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc AVOBENZONE; OCTINOXATE 1.76; 4.7 g/235g; g/235g 50021-237_acb4d88f-ad55-43ab-866d-daf227fa9307 50021-237 HUMAN OTC DRUG SunZone Baby SPF 30 Sunscreen Broad Spectrum Octinoxate and Avobenzone LOTION TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc AVOBENZONE; OCTINOXATE 1.76; 4.7 g/235g; g/235g 50021-240_9b5a15c9-f298-4b95-89c6-1b12b775a941 50021-240 HUMAN OTC DRUG SunZone Work Sunscreen SPF-60 Broad Spectrum Avobenzone and Octinoxate LOTION TOPICAL 20121113 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. AVOBENZONE; OCTINOXATE 7.02; 9.36 g/234g; g/234g 50021-241_4805c9e5-d7eb-4433-aeb4-af9e2e5a53f6 50021-241 HUMAN OTC DRUG SunZone Baby Sunscreen SPF-60 Broad Spectrum Avobenzone and Octinoxate LOTION TOPICAL 20121113 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. AVOBENZONE; OCTINOXATE 7.02; 9.36 g/234g; g/234g 50021-242_645c0701-8d41-47ec-a3c1-d9d86f0475d0 50021-242 HUMAN OTC DRUG SunZone Sport Sunscreen SPF-60 Broad Spectrum Avobenzone and Octinoxate LOTION TOPICAL 20121113 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. AVOBENZONE; OCTINOXATE 7.02; 9.36 g/234g; g/234g 50021-243_da5f3a12-80ff-4afe-9a71-ac276041cfa1 50021-243 HUMAN OTC DRUG SunZone Family Sunscreen SPF-60 Broad Spectrum Avobenzone and Octinoxate LOTION TOPICAL 20121113 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. AVOBENZONE; OCTINOXATE 7.02; 9.36 g/234g; g/234g 50021-300_7fc98345-9dca-4511-ad3e-c1a0d977c8e0 50021-300 HUMAN OTC DRUG SunZone Kids SPF 30 Sunscreen Broad Spectrum Octinoxate and Avobenzone LOTION TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc AVOBENZONE; OCTINOXATE 1.76; 4.7 g/235g; g/235g 50021-301_4d17b269-7bb8-41ea-b188-8976ae6377cf 50021-301 HUMAN OTC DRUG SUNZONE SPORT SUNSCREEN SPF 30 Broad Spectrum Octisalate, Oxybenzone, Avobenzone and Homosalate. AEROSOL, SPRAY TOPICAL 20130102 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3.02; 22.65; 7.55; 6.04 g/151g; g/151g; g/151g; g/151g 50021-302_93f40589-36c8-40cc-b8fb-243fd6ddfea8 50021-302 HUMAN OTC DRUG SunZone Sunscreen Sport SPF 45 Broad Spectrum Octocrylene, Octisalate, Homosalate, Avobenzone and Oxybenzone AEROSOL, SPRAY TOPICAL 20130102 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 7.5; 3; 7.5 g/150g; g/150g; g/150g; g/150g; g/150g 50021-304_e93c22e7-f25d-4c70-a9c5-470747f547f2 50021-304 HUMAN OTC DRUG Sunzone Sunscreen Sport SPF 15 Broad Spectrum Octinoxate and Avobenzone LOTION TOPICAL 20121217 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. AVOBENZONE; OCTINOXATE 1.18; 2.35 g/235g; g/235g 50021-305_f08b93f6-e2dd-4457-b043-afb802ddcdc6 50021-305 HUMAN OTC DRUG Sunzone Sunscreen Sport SPF 60 Broad Spectrum Octinoxate, Octocrylene, Octisalate, Oxybenzone, Avobenzone and Homosalate. AEROSOL, SPRAY TOPICAL 20130102 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.65; 18.6; 7.75; 7.75; 7.75; 9.3 g/155g; g/155g; g/155g; g/155g; g/155g; g/155g 50021-306_b36d5ad3-c720-4e6b-abee-c4a7294c701d 50021-306 HUMAN OTC DRUG SunZone Sunscreen Kids SPF 60 Broad Spectrum Avobenzone and Octinoxate LOTION TOPICAL 20130102 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. AVOBENZONE; OCTINOXATE 7.02; 9.36 g/234g; g/234g 50021-307_62e4970f-149c-4188-9652-eb487232685f 50021-307 HUMAN OTC DRUG SunZone Sunscreen Family SPF 30 Broad Spectrum Octisalate, Oxybenzone, Avobenzone and Homosalate. AEROSOL, SPRAY TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3.02; 22.65; 7.55; 6.04 g/151g; g/151g; g/151g; g/151g 50021-508_bf716762-2dd4-4e3e-bdc1-cab9edf0326a 50021-508 HUMAN OTC DRUG SunZone Sunscreen Family SPF 30 Broad Spectrum Octinoxate and Avobenzone LOTION TOPICAL 20130102 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc AVOBENZONE; OCTINOXATE 1.76; 4.7 g/235g; g/235g 50025-1001_9a69d03e-bf9e-4c24-9e02-b7a2ba4b4500 50025-1001 HUMAN OTC DRUG DANCHUN JADE oriental herb cosmetics GLYCERIN LIQUID TOPICAL 20091101 OTC MONOGRAPH FINAL part347 UniqueInternational Co, Ltd GLYCERIN 1 kg/20kg 50030-001_9df32819-4a8f-4271-8be6-eb1af7ca2357 50030-001 HUMAN OTC DRUG GEM BEAUTY AMETHYST INTENSIVE FIRMING EYE CREAM ALOE VERA FLOWER CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part310.545 GEMPARK CO LTD ALOE VERA FLOWER 5.4 mL/30mL 50030-003_15aac30d-fbe4-493f-ad9e-7d6aeb3e84a7 50030-003 HUMAN OTC DRUG GEM BEAUTY AMETHYST REJUVENATION CREAM ALOE VERA FLOWER CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part310.545 GEMPARK CO LTD ALOE VERA FLOWER 9.15 mL/50mL 50030-004_38e58c7a-aff7-46ce-8c3e-ba042531a5d6 50030-004 HUMAN OTC DRUG GEM BEAUTY AMETHYST PERFECT SOLUTION BB CREAM ALOE FEROX LEAF CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part310.545 GEMPARK CO LTD ALOE FEROX LEAF 6.65 g/50g 50036-514_a1c2ade4-3511-4214-be58-9da4c5eb3108 50036-514 HUMAN OTC DRUG Fikes Northwest Non-Alcohol Foaming Instant Hand Sanitizer Husky 514 SOLUTION TOPICAL 20091116 OTC MONOGRAPH NOT FINAL part333 Fikes Northwest, Corp. BENZALKONIUM CHLORIDE 1 g/1000mL 50036-515_bf64ef1f-5fc1-47ba-92dd-48061e8a866e 50036-515 HUMAN OTC DRUG FIKES INSTANT HAND SANITIZER alcohol GEL TOPICAL 20100721 OTC MONOGRAPH NOT FINAL part333 Fikes Northwest, Corp. ALCOHOL 600 mL/1000mL 50036-571_077f6779-3d56-4283-be25-8de99e7f4af0 50036-571 HUMAN OTC DRUG FIKES Foaming Anti-Microbial Food Service Hand Wash chloroxylenol LIQUID TOPICAL 19981028 OTC MONOGRAPH NOT FINAL part333E Fikes Northwest, Corp. CHLOROXYLENOL 15.75 g/1000mL 50048-012_d22ef9b8-fd49-42c4-995c-ab4c5e3ef8a1 50048-012 HUMAN OTC DRUG Kidney Stone Clear Berberis vulg, Calc carb, Cantharis, Lycopodium, Belladonna TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC W. Last CC ATROPA BELLADONNA; BERBERIS VULGARIS FRUIT; CALCIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA 6; 6; 6; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL 50048-015_bda02f69-7328-4cc8-9849-87fdc357c2b4 50048-015 HUMAN OTC DRUG ORAL ASSIST ORAL ASSIST TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC W LAST CC BELLADONNA LEAF; CALCIUM SULFIDE; FERROSOFERRIC PHOSPHATE; MERCURIUS SOLUBILIS; SALICYLIC ACID; SILICON DIOXIDE 30; 12; 6; 12; 6; 6 [hp_C]/33.33mg; [hp_C]/33.33mg; [hp_X]/33.33mg; [hp_C]/33.33mg; [hp_C]/33.33mg; [hp_X]/33.33mg 50048-138_f6e41cb3-c146-456d-9843-08ea53c43dbb 50048-138 HUMAN OTC DRUG Arnica Complex Arnica Montana TABLET ORAL 20091111 UNAPPROVED HOMEOPATHIC W Last CC ARNICA MONTANA 6 [hp_X]/1 50051-0001_c41d549d-9876-4de2-b35f-728c9d919ba2 50051-0001 HUMAN OTC DRUG Ariel Sun Smacker SPF 24 Strawberry Kiwi OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0002_36b6d2c0-b068-491b-87d0-529fb985ff57 50051-0002 HUMAN OTC DRUG Flounder Sun Smacker SPF 24 Watermelon Wave OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0003_61de5d4d-47d0-45bb-9129-608221978b92 50051-0003 HUMAN OTC DRUG Sebastian Sun Smacker SPF 24 Calypso Berry Beat OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0004_55ab1771-f287-4202-bb1a-ccc71a1b57f2 50051-0004 HUMAN OTC DRUG Donald Duck Sun Smacker SPF 24 Tropical Touchdown OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0005_157aa76a-7532-457d-9245-b575406212fe 50051-0005 HUMAN OTC DRUG Goofy Sun Smacker SPF 24 Berry Goal OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0006_1809a22c-3840-4d8c-83d0-211964a3c958 50051-0006 HUMAN OTC DRUG Mickey Sun Smacker SPF 24 Classic Sherbet OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0007_9986ca1b-b906-491d-97b8-62efc88b4998 50051-0007 HUMAN OTC DRUG Mickey Sun Smacker SPF 24 Classic Strawberry OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0008_717b9d65-5755-4c18-b8aa-b8773c9bbac6 50051-0008 HUMAN OTC DRUG Mickey Sun Smacker SPF 24 Classic Vanilla OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0009_74a1bec1-d18c-4ee1-9d4e-dcddb151fb7d 50051-0009 HUMAN OTC DRUG Mickey Sun Smacker SPF 24 Home Run Star Fruit OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0010_40efbbc3-9043-4d93-ae59-201297eaf787 50051-0010 HUMAN OTC DRUG Lightning McQueen Sun Smacker SPF 24 Revved Up Raspberry OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0011_82217fee-8d08-4b92-975a-a9e8f5742355 50051-0011 HUMAN OTC DRUG Tow Mater Sun Smacker SPF 24 Tow-Tally Orange OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0012_3b2bfa0e-90ae-4420-848d-41b2e5d17c3a 50051-0012 HUMAN OTC DRUG Fin McMissie Sun Smacker SPF 24 Vroom Vroom Vanilla OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0013_173b8d28-812f-499d-984e-aec4d17de752 50051-0013 HUMAN OTC DRUG Phineas and Ferb Sun Smacker SPF 24 Berry Busted OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0014_00ac9d57-dd1a-4312-bed0-ab575f851fa9 50051-0014 HUMAN OTC DRUG Phineas and Ferb Sun Smacker SPF 24 Secret Agent Strawberry OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0015_f44cc17c-bb7d-49ce-95c6-7c1746cd6316 50051-0015 HUMAN OTC DRUG Phineas and Ferb Sun Smacker SPF 24 Vanilla Vacation OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0016_0bfe070d-bca0-47c0-9b7d-bd5524918de7 50051-0016 HUMAN OTC DRUG Lip Smacker SPF 24 Cool Strawberry Orange OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0017_1d76301f-bf65-4393-9481-7fcbd62192f5 50051-0017 HUMAN OTC DRUG Lip Smacker SPF 24 Vanilla Ice OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0018_718df646-b00e-447b-947c-b451dd8d72d8 50051-0018 HUMAN OTC DRUG Lip Smacker SPF Cherry Berry Ball OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0019_501e08e6-2970-46f8-ac50-e222f62855e8 50051-0019 HUMAN OTC DRUG Lip Smacker SPF 24 Lemon Lime Rush OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0020_61dbbea0-04f0-45b2-bd3f-d0c2c42f84c5 50051-0020 HUMAN OTC DRUG Lip Smacker SPF 24 Melon Extreme OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0021_d5acd24d-91d1-40fc-95ab-97defd7cc1f4 50051-0021 HUMAN OTC DRUG Lip Smacker SPF 24 Strawberry Scoop OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0022_5fbdd8bb-c47e-47cd-9655-7bf0204a1e53 50051-0022 HUMAN OTC DRUG Lip Smacker SPF 24 Kiwi Berry Crush OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0023_e3d9ee30-db14-44bb-8d40-2ab87bd8c270 50051-0023 HUMAN OTC DRUG Lip Smacker SPF 24 Power Punch OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50051-0024_40f33076-d0e2-4622-b204-47c222129bfb 50051-0024 HUMAN OTC DRUG Lip Smacker SPF 24 Watermelon Wave OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g 50061-001_eb5cb0fd-671e-4681-a7b2-796c3b850c4d 50061-001 HUMAN OTC DRUG Command AntiBac Instant Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20091217 OTC MONOGRAPH NOT FINAL part333 FAZ Marketing ALCOHOL 62 mL/100mL 50061-381_12f07b17-b920-47be-b652-6e51d91bbc96 50061-381 HUMAN OTC DRUG Multi Symptom Cold Double Max Power dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20140601 OTC MONOGRAPH FINAL part341 FAZ Marketing DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL 50063-001_9e9ef7dc-51e9-48d2-a1ff-b2fea0537c32 50063-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070101 NDA NDA205767 Andy-Oxy Co., Inc. OXYGEN 995 mL/L 50063-002_5ea100db-60d2-4d06-abc3-45f59e21c5a1 50063-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20130101 NDA NDA205766 Andy-Oxy Co., Inc. NITROGEN 992 mL/L 50063-003_40e3a56e-cc6b-4f13-b36c-a905108423fa 50063-003 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20070101 UNAPPROVED MEDICAL GAS Andy-Oxy Co., Inc. AIR 1000 mL/L 50066-001_79e8c9ea-fe91-474b-8392-67ae85c973c3 50066-001 HUMAN OTC DRUG Nikzon Hemorrhoidal PHENYLEPHRINE HYDROCHLORIDE and PRAMOXINE HYDROCHLORIDE CREAM TOPICAL 20131201 OTC MONOGRAPH FINAL part346 Genoma Lab USA Inc PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 2.5; 10 mg/g; mg/g 50066-002_566a5a7d-38d2-484a-b71e-6f8edfd42247 50066-002 HUMAN OTC DRUG Cicatricure Ultra Moisturizing HYDROCORTISONE CREAM TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part348 Genoma Lab USA Inc HYDROCORTISONE 10 mg/g 50066-013_c05afd85-a5f5-4738-b9f5-81df93866364 50066-013 HUMAN OTC DRUG Pomada De La Campana Triple Antibiotic Pain Relief Bacitracin, Neomycin sulfate, Polymyxin B sulfate, Pramoxine Hydrochloride CREAM TOPICAL 20140630 OTC MONOGRAPH FINAL part333B Genomma Lab USA, Inc. BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 50066-057_6613842a-e72d-4cd3-bc77-116df9161a99 50066-057 HUMAN OTC DRUG RAY DOL Pain Relieving Cream CREAM TOPICAL 20131215 OTC MONOGRAPH NOT FINAL part348 Genomma Lab USA Inc. MENTHOL; METHYL SALICYLATE 100; 150 mg/g; mg/g 50066-065_06a0a2cf-fda0-4e10-81a4-b22b83c81c79 50066-065 HUMAN OTC DRUG Nasalub Nasal Relief Oxymetazoline HCL SPRAY NASAL 20141202 OTC MONOGRAPH FINAL part341 Genomma Lab USA, Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 50066-070_1dddb608-689c-4642-b98d-113b18e354ef 50066-070 HUMAN OTC DRUG Lagicam antifungal Miconazole Nitrate CREAM VAGINAL 20050302 ANDA ANDA076773 Genomma Lab USA, Inc. MICONAZOLE NITRATE 40 mg/g 50066-080_1b71fc66-77ce-4d3c-ae78-358851dfb6b5 50066-080 HUMAN OTC DRUG Silka Antifungal Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Genomma Lab USA, Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g 50066-161_671d14d7-d8b7-4999-94ac-727cb237b564 50066-161 HUMAN OTC DRUG DR BELLS POMADE Triple Antibiotic Plus Pain Relief OINTMENT TOPICAL 20120516 OTC MONOGRAPH FINAL part333B Genomma lab USA Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 50066-504_67ddf6a5-32d4-4e11-a58b-74e5eb1007ac 50066-504 HUMAN OTC DRUG Tukol Multi Symptom Cold DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20120515 OTC MONOGRAPH FINAL part341 Genomma Lab USA, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 50066-533_0689aebf-05f6-4b57-b504-a8edda725871 50066-533 HUMAN OTC DRUG Tukol X-Pecto Miel Multi Symptom Cold DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20130915 OTC MONOGRAPH FINAL part341 Genomma Lab USA, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 50066-536_d4f36882-86fc-4ca2-811f-c97193fb596a 50066-536 HUMAN OTC DRUG Tukol A DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20140609 OTC MONOGRAPH FINAL part341 Genomma Lab USA, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 50; 2.5 mg/5mL; mg/5mL; mg/5mL 50076-100_7dcdb3a3-3cbf-4a1f-aa07-abb28fe66b78 50076-100 HUMAN OTC DRUG AIDPLUS ALCOHOL CLEANSING PAD ALCOHOL SWAB TOPICAL 20101013 OTC MONOGRAPH NOT FINAL part333E Planet (Suzhou) Medical Products Co. Ltd ALCOHOL 70 g/100g 50076-200_451dc30e-d7da-46b4-873d-aa14066868e5 50076-200 HUMAN OTC DRUG AIDPLUS STING RELIEF PREP PAD ALCOHOL, BENZOCAINE SWAB TOPICAL 20101013 OTC MONOGRAPH NOT FINAL part333E Planet (Suzhou) Medical Products Co. Ltd ALCOHOL; BENZOCAINE 70; 6 g/100g; g/100g 50076-300_e5ec3d59-6eed-4402-a4a4-46e118244bda 50076-300 HUMAN OTC DRUG PARAID Extra Strength Menthol Pain Relief Sleeve KNEE Large Ankles Elbows MENTHOL LOTION TOPICAL 20140929 OTC MONOGRAPH NOT FINAL part348 Planet (Suzhou) Medical Products Co., Ltd. MENTHOL 160 mg/mL 50076-301_a11f1787-1e06-4672-9d22-b9cb4a1667f3 50076-301 HUMAN OTC DRUG PARAID Extra Strength Menthol Pain Relief Sleeve WRIST and Small Ankles and Elbows MENTHOL LOTION TOPICAL 20140929 OTC MONOGRAPH NOT FINAL part348 Planet (Suzhou) Medical Products Co., Ltd. MENTHOL 160 mg/mL 50078-101_6751ad6e-a9c1-4d10-a8ca-5cf089a81fc7 50078-101 HUMAN OTC DRUG Ed Hardy Habit Antiseptic Hand Sanitizing Wipe BENZALKONIUM CHLORIDE SWAB TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Ed Hardy Habit BENZALKONIUM CHLORIDE .12 1/1 50078-201_d34dd3f5-ad9a-4ce4-90b0-d8f3a3d6a0f0 50078-201 HUMAN OTC DRUG Ed Hardy Habit Antiseptic Hand Sanitizing Wipe BENZALKONIUM CHLORIDE SWAB TOPICAL 20091209 OTC MONOGRAPH NOT FINAL part333 Ed Hardy Habit BENZALKONIUM CHLORIDE .12 1/1 50080-001_f36e7d43-9c66-4973-9966-f354222be7c5 50080-001 HUMAN OTC DRUG DermaTAF Antifungal Treatment TOLNAFTATE SOLUTION TOPICAL 20120524 OTC MONOGRAPH FINAL part333C DermaTAF, Inc. TOLNAFTATE 1 mL/100mL 50080-002_6a359b34-6bdd-4f09-81b0-09191be78853 50080-002 HUMAN OTC DRUG DermaTAF Antifungal Treatment TOLNAFTATE SOLUTION TOPICAL 20130115 OTC MONOGRAPH FINAL part333C DermaTAF, Inc. TOLNAFTATE 10 mg/mL 50090-0006_88dcb2e9-a6a5-42fb-9f0e-252c6d8c47f3 50090-0006 HUMAN PRESCRIPTION DRUG TYLENOL with Codeine acetaminophen and codeine phosphate TABLET ORAL 19770817 ANDA ANDA085055 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 50090-0007_6f5ad523-2d2f-498f-a563-fef16013eb12 50090-0007 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 50090-0008_9906dc2c-1b2f-4ee9-9c37-a82d9bd450c5 50090-0008 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 50090-0009_22923b90-bc39-4575-9ced-e7554d3cb3b6 50090-0009 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 50090-0039_20ee067c-1d7a-465e-b338-5f45579d3dd4 50090-0039 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19771117 ANDA ANDA085762 A-S Medication Solutions LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 50090-0040_0ceb4133-f643-49cc-acb7-c5035a360064 50090-0040 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19771117 ANDA ANDA085762 A-S Medication Solutions LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 50090-0067_6f5ad523-2d2f-498f-a563-fef16013eb12 50090-0067 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089828 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 50090-0085_41c49e79-ede2-4ef1-a917-51a0117db71d 50090-0085 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089990 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 50090-0103_811e02e5-8634-4fc5-a993-986f72aef084 50090-0103 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, Caffeine and Codeine Phosphate Butalbital, Aspirin, Caffeine and Codeine Phosphate CAPSULE ORAL 20061026 NDA AUTHORIZED GENERIC NDA019429 A-S Medication Solutions LLC ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 50090-0118_128e41ea-5d4b-4aaf-81e6-13a26b797d84 50090-0118 HUMAN PRESCRIPTION DRUG DIDREX benzphetamine hydrochloride TABLET ORAL 19601026 NDA NDA012427 A-S Medication Solutions LLC BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 50090-0119_2cf9c28a-c96e-4d95-8d02-10c0a7af68ee 50090-0119 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 A-S Medication Solutions LLC PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50090-0120_6def5886-4fe2-4a5d-a955-c17f370449ef 50090-0120 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride ER Diethylpropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111024 ANDA ANDA091680 A-S Medication Solutions LLC DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50090-0121_07192e49-ac9c-4f5f-833a-dffcf3762f16 50090-0121 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 19601117 NDA NDA012546 A-S Medication Solutions LLC DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50090-0155_6dbc85d6-7224-4812-9699-b2b3f2712dca 50090-0155 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 19941001 OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 50090-0186_b20298a3-352a-47d1-a64e-239673763592 50090-0186 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 A-S Medication Solutions LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0192_c725789b-c900-4af7-8065-597bd1d5a3d2 50090-0192 HUMAN PRESCRIPTION DRUG Ativan lorazepam TABLET ORAL 20130501 NDA NDA017794 A-S Medication Solutions LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0193_4f9682cd-1d39-4cd2-a7bb-545fc04c7739 50090-0193 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 A-S Medication Solutions LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0194_2cc7db81-0f4d-4e17-b5b7-53e1d8ba75db 50090-0194 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 A-S Medication Solutions LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0195_07771ccb-2eaa-46b1-971a-46151571c7fd 50090-0195 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071307 A-S Medication Solutions LLC DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0196_4f9682cd-1d39-4cd2-a7bb-545fc04c7739 50090-0196 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 A-S Medication Solutions LLC DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0197_4f9682cd-1d39-4cd2-a7bb-545fc04c7739 50090-0197 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 A-S Medication Solutions LLC DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0198_2cc7db81-0f4d-4e17-b5b7-53e1d8ba75db 50090-0198 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 A-S Medication Solutions LLC DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0215_ecbddfe7-3a93-4b3c-9e0d-6daa5ce9e3b4 50090-0215 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate ACETAMINOPHEN and CODEINE PHOSPHATE SOLUTION ORAL 19810821 ANDA ANDA087508 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 50090-0216_a39c8a2d-c445-496b-a0f0-91fd4f960855 50090-0216 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate ACETAMINOPHEN and CODEINE PHOSPHATE SOLUTION ORAL 19810821 ANDA ANDA087508 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 50090-0223_d4c477bf-0650-4971-9fc9-ef0cda53104b 50090-0223 HUMAN PRESCRIPTION DRUG Promethazine VC With Codeine Codeine Phosphate, Promethazine Hydrochloride, and Phenylephrine Hydrochloride SYRUP ORAL 20061207 ANDA ANDA040660 A-S Medication Solutions LLC CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10; 5; 6.25 mg/5mL; mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] CV 50090-0272_92ea8b10-c1d0-423a-ac5c-2f3756f1a028 50090-0272 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 A-S Medication Solutions LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0273_2a5c31be-0777-4caf-a5b9-4fb3cc5f2d88 50090-0273 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 A-S Medication Solutions LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0274_f4e7f3c9-78d0-4e0f-8f31-afdf5243b72c 50090-0274 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20060510 ANDA ANDA077754 A-S Medication Solutions LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0275_c47020b2-1a39-4131-99ea-a8858a3edf56 50090-0275 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20060510 ANDA ANDA077754 A-S Medication Solutions LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0280_a63d26ec-b42c-4481-a8ff-70773122b7c6 50090-0280 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070227 ANDA ANDA040755 A-S Medication Solutions LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 50090-0281_d6e7852a-3a1e-4fd0-95ca-21815adfead4 50090-0281 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070227 ANDA ANDA040755 A-S Medication Solutions LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 50090-0284_d4bae49b-2220-433c-ad6f-463ed6059cfc 50090-0284 HUMAN PRESCRIPTION DRUG Adipex-P Phentermine Hydrochloride TABLET ORAL 19900930 ANDA ANDA085128 A-S Medication Solutions LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50090-0285_b20298a3-352a-47d1-a64e-239673763592 50090-0285 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 A-S Medication Solutions LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0326_07192e49-ac9c-4f5f-833a-dffcf3762f16 50090-0326 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Immediate-Release Diethylpropion hydrochloride TABLET ORAL 19590806 NDA NDA011722 A-S Medication Solutions LLC DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50090-0327_0eb755eb-e03c-47cc-b7ab-381809e413ac 50090-0327 HUMAN PRESCRIPTION DRUG DIETHYLPROPION HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE TABLET ORAL 20101227 ANDA ANDA201212 A-S Medication Solutions LLC DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50090-0328_339dc28a-0492-4371-b2a2-d0d407efaa64 50090-0328 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19760702 ANDA ANDA084769 A-S Medication Solutions LLC CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0330_2e012e8e-8245-45f7-a5b6-9016860ba430 50090-0330 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION INTRAMUSCULAR 20120501 ANDA ANDA091244 A-S Medication Solutions LLC TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 50090-0331_5f49c205-cb3c-48b9-8e14-f1261b276062 50090-0331 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20110504 ANDA ANDA086030 A-S Medication Solutions LLC TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 50090-0338_b2a21025-a0ec-44aa-bb8c-7bffab47baab 50090-0338 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate CAPSULE, EXTENDED RELEASE ORAL 19770906 NDA NDA018074 A-S Medication Solutions LLC PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 50090-0385_6922b22f-e6a1-4e61-a11c-64ba9f03f4e2 50090-0385 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 A-S Medication Solutions LLC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 50090-0386_1a6e9aad-3d9f-4ae6-ac11-66fa767c5507 50090-0386 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 A-S Medication Solutions LLC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 50090-0387_92ea8b10-c1d0-423a-ac5c-2f3756f1a028 50090-0387 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072926 A-S Medication Solutions LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0415_60fd03fb-55d2-463b-bac3-25e9586aaa88 50090-0415 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 A-S Medication Solutions LLC PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50090-0416_2cf9c28a-c96e-4d95-8d02-10c0a7af68ee 50090-0416 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040875 A-S Medication Solutions LLC PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50090-0423_e98a4fc1-e2d1-473a-b5c4-4736c9dbb9a5 50090-0423 HUMAN OTC DRUG Cheratussin AC codeine phosphate and guaifenesin LIQUID ORAL 19960901 OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 50090-0465_de076158-0417-4c94-8fef-f8e120bb8b3b 50090-0465 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 A-S Medication Solutions LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0466_de076158-0417-4c94-8fef-f8e120bb8b3b 50090-0466 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 A-S Medication Solutions LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0531_083f0327-5cc7-4e23-854a-6c233139d2a0 50090-0531 HUMAN PRESCRIPTION DRUG ULTRAM tramadol hydrochloride TABLET, COATED ORAL 19950303 NDA NDA020281 A-S Medication Solutions LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 50090-0536_2cf9c28a-c96e-4d95-8d02-10c0a7af68ee 50090-0536 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 A-S Medication Solutions LLC PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50090-0623_de076158-0417-4c94-8fef-f8e120bb8b3b 50090-0623 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 A-S Medication Solutions LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0663_c933754c-ba02-4345-82cd-dbb3169f0263 50090-0663 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20101015 ANDA ANDA090248 A-S Medication Solutions LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0686_26dc1837-d05a-405b-b1de-49c6ca9bd37b 50090-0686 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 A-S Medication Solutions LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0715_6922b22f-e6a1-4e61-a11c-64ba9f03f4e2 50090-0715 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 A-S Medication Solutions LLC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 50090-0721_26dc1837-d05a-405b-b1de-49c6ca9bd37b 50090-0721 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 A-S Medication Solutions LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-0746_cbb703bb-e568-4ce4-8070-05d56c2481fb 50090-0746 HUMAN PRESCRIPTION DRUG Depo-Testosterone testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 19790725 ANDA ANDA085635 A-S Medication Solutions LLC TESTOSTERONE CYPIONATE 100 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 50090-0748_42573fcc-c3aa-4a0d-a67a-756fedbb5f60 50090-0748 HUMAN PRESCRIPTION DRUG ULTRACET tramadol hydrochloride and acetaminophen TABLET, COATED ORAL 20010815 NDA NDA021123 A-S Medication Solutions LLC ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 50090-0806_65d15011-1f92-42fb-aeed-11b90beb3f02 50090-0806 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 A-S Medication Solutions LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 50090-0807_feb48256-66c5-4892-96b1-961aa75473e1 50090-0807 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 A-S Medication Solutions LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 50090-0843_d19c86c0-87b5-4197-a8a6-3dac998aac8e 50090-0843 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 A-S Medication Solutions LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50090-0844_6cf6bb42-9e6b-413f-8541-1e7aeac7704d 50090-0844 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 A-S Medication Solutions LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50090-0875_ba05a577-81aa-4582-a1c9-f2b34191bd64 50090-0875 HUMAN PRESCRIPTION DRUG Testim testosterone GEL TRANSDERMAL 20021031 NDA NDA021454 A-S Medication Solutions LLC TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 50090-0924_b5b93e02-f462-4a04-b304-b020436a2e29 50090-0924 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 A-S Medication Solutions LLC ESZOPICLONE 3 mg/1 CIV 50090-0930_b5b93e02-f462-4a04-b304-b020436a2e29 50090-0930 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 A-S Medication Solutions LLC ESZOPICLONE 2 mg/1 CIV 50090-0993_1d833404-56e2-4ce9-b194-3714972b4a31 50090-0993 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 A-S Medication Solutions LLC PREGABALIN 75 mg/1 CV 50090-1022_3dff30f3-d71d-4735-a094-1c27930b45ac 50090-1022 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 A-S Medication Solutions LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 50090-1023_3dff30f3-d71d-4735-a094-1c27930b45ac 50090-1023 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 A-S Medication Solutions LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 50090-1024_b4ff35a3-081c-4e80-839e-d5c3c217107a 50090-1024 HUMAN PRESCRIPTION DRUG BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET ORAL 20100721 ANDA ANDA090968 A-S Medication Solutions LLC BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 50090-1084_705189b3-d247-444e-aaec-191b375e1cc2 50090-1084 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120412 ANDA ANDA201013 A-S Medication Solutions LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50090-1113_accbe9c0-47e8-4534-8d22-4516c677488f 50090-1113 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040526 A-S Medication Solutions LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50090-1156_ea16103f-e4ac-4959-b5f1-7e5c6ae4c524 50090-1156 HUMAN OTC DRUG Cheratussin AC codeine phosphate and guaifenesin LIQUID ORAL 19960901 OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 50090-1222_17f086f5-883b-4146-a61f-3f83cc719858 50090-1222 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110607 ANDA ANDA078179 A-S Medication Solutions LLC ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 50090-1229_1d833404-56e2-4ce9-b194-3714972b4a31 50090-1229 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 A-S Medication Solutions LLC PREGABALIN 50 mg/1 CV 50090-1230_1b9d03bf-e697-4887-923f-888161eaf640 50090-1230 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 A-S Medication Solutions LLC PREGABALIN 50 mg/1 CV 50090-1231_1d833404-56e2-4ce9-b194-3714972b4a31 50090-1231 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 A-S Medication Solutions LLC PREGABALIN 100 mg/1 CV 50090-1232_1b9d03bf-e697-4887-923f-888161eaf640 50090-1232 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 A-S Medication Solutions LLC PREGABALIN 100 mg/1 CV 50090-1304_1d833404-56e2-4ce9-b194-3714972b4a31 50090-1304 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 A-S Medication Solutions LLC PREGABALIN 150 mg/1 CV 50090-1305_1b9d03bf-e697-4887-923f-888161eaf640 50090-1305 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 A-S Medication Solutions LLC PREGABALIN 150 mg/1 CV 50090-1335_17f086f5-883b-4146-a61f-3f83cc719858 50090-1335 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101013 ANDA ANDA078179 A-S Medication Solutions LLC ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 50090-1464_8bec4588-b228-4688-baf3-d3e8ef750130 50090-1464 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, and Caffeine butalbital, aspirin, and caffeine CAPSULE ORAL 20031006 NDA AUTHORIZED GENERIC NDA017534 A-S Medication Solutions LLC ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 50090-1465_54029255-44d7-4608-85e8-1079be697888 50090-1465 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, and Caffeine butalbital, aspirin, and caffeine CAPSULE ORAL 20031006 NDA AUTHORIZED GENERIC NDA017534 A-S Medication Solutions LLC ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 50090-1474_fa142c62-dd08-450c-bf55-feaa697c2079 50090-1474 HUMAN PRESCRIPTION DRUG Quazepam QUAZEPAM TABLET ORAL 20130808 NDA NDA018708 A-S Medication Solutions LLC QUAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50090-1482_78f22985-03b5-4d5f-a257-db5331a6bf91 50090-1482 HUMAN PRESCRIPTION DRUG promethazine hydrochloride and codeine phosphate promethazine hydrochloride and codeine phosphate SYRUP ORAL 20100317 ANDA ANDA090180 A-S Medication Solutions LLC CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 50090-1483_c933754c-ba02-4345-82cd-dbb3169f0263 50090-1483 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20101015 ANDA ANDA090248 A-S Medication Solutions LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50093-001_4032003d-dd6e-4695-a300-05184598cb93 50093-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100209 UNAPPROVED MEDICAL GAS Centrad Healthcare, LLC OXYGEN 995 mL/L 50096-501_36b3b279-d00f-41b7-8be6-bcbad165010d 50096-501 HUMAN PRESCRIPTION DRUG Urea 47% Cream UREA CREAM TOPICAL 20110701 UNAPPROVED DRUG OTHER Rosemar Labs, LLC UREA 470 mg/g 50096-502_ed03cc54-58fa-4325-a555-35decbe23133 50096-502 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser SULFACETAMIDE SODIUM, SULFUR LIQUID TOPICAL 20050901 UNAPPROVED DRUG OTHER Rosemar Labs, LLC SULFACETAMIDE SODIUM; SULFUR 98; 48 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 50096-503_9d7dddee-7344-4e31-9660-11275cf0a13a 50096-503 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cream SULFACETAMIDE SODIUM, SULFUR CREAM TOPICAL 20050901 UNAPPROVED DRUG OTHER Rosemar Labs, LLC SULFACETAMIDE SODIUM; SULFUR 98; 48 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 50096-505_52451190-3490-493b-9fc3-61bf53279977 50096-505 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 9.8% and Sulfur 4.8% SULFACETAMIDE SODIUM, SULFUR LOTION TOPICAL 20050901 UNAPPROVED DRUG OTHER Rosemar Labs, LLC SULFACETAMIDE SODIUM; SULFUR 98; 48 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 50101-0001_40e80052-9d05-49d4-b280-f3684a8ab96a 50101-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090903 UNAPPROVED MEDICAL GAS Laramie Respiratory Service OXYGEN 99 L/100L 50102-100_26a2cd06-6d81-4bb9-b6de-287586164b15 50102-100 HUMAN PRESCRIPTION DRUG Lyza norethindrone TABLET ORAL 20130624 ANDA ANDA200980 Afaxys Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 50102-120_77c9e72a-ce51-4317-92f9-7a58a17d2aea 50102-120 HUMAN PRESCRIPTION DRUG AUBRA Levonorgestrel and Ethinyl Estradiol KIT 20131015 ANDA ANDA200245 Afaxys Inc. 50102-128_a2f54e28-27bb-4baf-a4b6-25a0d89944b8 50102-128 HUMAN PRESCRIPTION DRUG TARINA Fe 1/20 norethindrone acetate and ethinyl estradiol KIT 20140915 ANDA ANDA202772 Afaxys Inc. 50102-130_d935aa7b-2cff-42e4-bd40-e37473582452 50102-130 HUMAN PRESCRIPTION DRUG Chateal Levonorgestrel and Ethinyl Estradiol KIT 20130122 ANDA ANDA091663 Afaxys Inc. 50102-911_7707de81-9aab-49fa-bb24-4df95f84eed2 50102-911 HUMAN PRESCRIPTION DRUG Ella ulipristal acetate TABLET ORAL 20100813 NDA NDA022474 Afaxys Inc. ULIPRISTAL ACETATE 30 mg/1 50107-100_dd6beeaf-c547-43cc-88e0-ffe9b64d9900 50107-100 HUMAN OTC DRUG Reme-Flu BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , KIT 20091222 UNAPPROVED HOMEOPATHIC Legacy Biotechnologies Inc. 50111-323_d5749535-da8b-40ad-9a12-e3fa287b617b 50111-323 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 19900930 ANDA ANDA089095 Pliva Inc. BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 50111-324_d5749535-da8b-40ad-9a12-e3fa287b617b 50111-324 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 19900930 ANDA ANDA088440 Pliva Inc. BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 50111-325_d5749535-da8b-40ad-9a12-e3fa287b617b 50111-325 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 19900930 ANDA ANDA088441 Pliva Inc. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 50111-326_d5749535-da8b-40ad-9a12-e3fa287b617b 50111-326 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 19900930 ANDA ANDA089096 Pliva Inc. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 50111-327_f1bb5be7-e8b0-4dd1-be95-afac3d59c460 50111-327 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19900930 ANDA ANDA088467 Pliva Inc. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 50111-328_f1bb5be7-e8b0-4dd1-be95-afac3d59c460 50111-328 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19900930 ANDA ANDA088468 Pliva Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 50111-333_022858bd-2cbb-41f2-a6d2-31cede871341 50111-333 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070027 Pliva Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 50111-334_022858bd-2cbb-41f2-a6d2-31cede871341 50111-334 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070033 Pliva Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 50111-393_13f8d3ee-5cc7-40af-8774-2f05a0a7f160 50111-393 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 19900930 ANDA ANDA089058 Pliva Inc. BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 50111-394_13f8d3ee-5cc7-40af-8774-2f05a0a7f160 50111-394 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 19900930 ANDA ANDA089059 Pliva Inc. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 50111-395_13f8d3ee-5cc7-40af-8774-2f05a0a7f160 50111-395 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 19900930 ANDA ANDA089060 Pliva Inc. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 50111-397_f1bb5be7-e8b0-4dd1-be95-afac3d59c460 50111-397 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19900930 ANDA ANDA089098 Pliva Inc. HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 50111-398_f1bb5be7-e8b0-4dd1-be95-afac3d59c460 50111-398 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19900930 ANDA ANDA089097 Pliva Inc. HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 50111-433_23776395-a0dc-4599-aca4-920cfff6bd6d 50111-433 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 Pliva Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 50111-434_23776395-a0dc-4599-aca4-920cfff6bd6d 50111-434 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071524 Pliva Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 50111-441_23776395-a0dc-4599-aca4-920cfff6bd6d 50111-441 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071525 Pliva Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 50111-456_f31ecbfd-0404-4601-9887-14dbba9cb7ce 50111-456 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 19900930 ANDA ANDA071655 Pliva Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 50111-459_a66a97c2-4d2b-4e4b-967e-1c8b67e364d9 50111-459 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19900930 ANDA ANDA089763 Pliva Inc. THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 50111-467_e05b9c4c-d796-4ba5-b017-c07d9fc1efe8 50111-467 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 ANDA ANDA071972 Pliva Inc. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50111-468_e05b9c4c-d796-4ba5-b017-c07d9fc1efe8 50111-468 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 ANDA ANDA071973 Pliva Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50111-469_e05b9c4c-d796-4ba5-b017-c07d9fc1efe8 50111-469 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 ANDA ANDA071974 Pliva Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50111-470_e05b9c4c-d796-4ba5-b017-c07d9fc1efe8 50111-470 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 ANDA ANDA071975 Pliva Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50111-471_e05b9c4c-d796-4ba5-b017-c07d9fc1efe8 50111-471 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 ANDA ANDA071976 Pliva Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50111-482_a66a97c2-4d2b-4e4b-967e-1c8b67e364d9 50111-482 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19900930 ANDA ANDA089808 Pliva Inc. THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 50111-483_a66a97c2-4d2b-4e4b-967e-1c8b67e364d9 50111-483 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19900930 ANDA ANDA089807 Pliva Inc. THEOPHYLLINE ANHYDROUS 100 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 50111-518_a66a97c2-4d2b-4e4b-967e-1c8b67e364d9 50111-518 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19931031 ANDA ANDA081236 Pliva Inc. THEOPHYLLINE ANHYDROUS 450 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 50111-563_8c5b9804-2e8b-4e96-95b3-75d13d6ca1e2 50111-563 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19950929 ANDA ANDA074421 Pliva Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 50111-647_d1866ec9-7860-473e-8d44-7a1a7547df06 50111-647 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Pliva Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50111-648_d1866ec9-7860-473e-8d44-7a1a7547df06 50111-648 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Pliva Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50111-787_ce70b1f6-83bb-4672-ad82-e6aa5a99ce9c 50111-787 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065225 Pliva, Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 50111-788_ce70b1f6-83bb-4672-ad82-e6aa5a99ce9c 50111-788 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065223 Pliva, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 50111-794_fdd97121-124a-4f5e-92d7-f7d4865059a5 50111-794 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20070817 ANDA ANDA065265 Pliva Inc. AZITHROMYCIN MONOHYDRATE 100 mg/mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 50111-851_2e0b6f35-6a3e-45be-8b40-66ed602983bb 50111-851 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 19930401 20150831 ANDA ANDA081297 Pliva Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 50111-852_0509eaf3-39ab-4934-9a7e-27367601b5e4 50111-852 HUMAN PRESCRIPTION DRUG VALPROIC ACID VALPROIC ACID CAPSULE, LIQUID FILLED ORAL 19931031 ANDA ANDA073484 Pliva Inc. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 50111-901_20ec34ae-c48c-486d-b1fc-12b6db2348ba 50111-901 HUMAN PRESCRIPTION DRUG Ethosuximide Ethosuximide CAPSULE ORAL 20021101 ANDA ANDA040430 Pliva Inc. ETHOSUXIMIDE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50111-915_14da49dc-4f13-4c5f-89c7-8e0ba83c4b39 50111-915 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20040601 ANDA ANDA076346 Pliva, Inc TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 50111-916_14da49dc-4f13-4c5f-89c7-8e0ba83c4b39 50111-916 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20040601 ANDA ANDA076346 Pliva, Inc TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 50111-917_14da49dc-4f13-4c5f-89c7-8e0ba83c4b39 50111-917 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20040601 ANDA ANDA076346 Pliva, Inc TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 50111-918_14da49dc-4f13-4c5f-89c7-8e0ba83c4b39 50111-918 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20041020 ANDA ANDA076346 Pliva, Inc TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 50111-990_97bb903a-5378-4c4a-a5ee-167db42c97a5 50111-990 HUMAN PRESCRIPTION DRUG ERGOCALCIFEROL ERGOCALCIFEROL CAPSULE ORAL 20020601 ANDA ANDA080704 Pliva Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 50112-514_8ed3fc29-b4cc-4bda-a674-0da3085169e9 50112-514 HUMAN OTC DRUG Envirokleen Non-Alcohol Instant Hand Sanitizer Husky 514 SOLUTION TOPICAL 20091116 OTC MONOGRAPH NOT FINAL part333 EnviroKleen LLC BENZALKONIUM CHLORIDE 1 g/mL 50112-515_250723d7-ec8a-4f2b-a09c-ffda6b655944 50112-515 HUMAN OTC DRUG Envirokleen Instant Hand Sanitizer alcohol GEL TOPICAL 20110309 OTC MONOGRAPH NOT FINAL part333E EnviroKleen LLC ALCOHOL 600 mL/1000mL 50114-0104_3096b050-7d31-4c15-8559-c02bf88e23c1 50114-0104 HUMAN PRESCRIPTION DRUG Tonsilla compositum CONIUM MACULATUM FLOWERING TOP, SOLANUM DULCAMARA TOP, ECHINACEA, UNSPECIFIED, HORSE CHESTNUT,ANTIMONY POTASSIUM TARTRATE, ASCORBIC ACID, PROTORTONIA CACTI,GALIUM APARINE,GENTIANA LUTEA ROOT,GERANIUM ROBERTIANUM, PULSATILLA VULGARIS,LACTIC ACID, L-, SUS SCROFA ADRENAL GLAND,SULFUR,TRIBASIC CALCIUM PHOSPHATE,FERROSOFERRIC PHOSPHATE,SUS SCROFA UMBILICAL CORD,PORK LIVER,SUS SCROFA HYPOTHALAMUSSUS SCROFA BONE MARROW,SUS SCROFA SPLEEN,SUS SCROFA ADRENAL GLAND, CORTISONE ACETATE, SUS SCROFA EMBRYO, SOLUTION ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; BARIUM CARBONATE; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; HORSE CHESTNUT; LACTIC ACID, L-; LEVOTHYROXINE; MERCURIUS SOLUBILIS; PORK LIVER; PROTORTONIA CACTI; PULSATILLA VULGARIS; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA EMBRYO; SUS SCROFA HYPOTHALAMUS; SUS SCROFA SPLEEN; SUS SCROFA TONSIL; SUS SCROFA UMBILICAL CORD; TRIBASIC CALCIUM PHOSPHATE 6; 6; 28; 4; 13; 4; 10; 6; 6; 6; 6; 6; 13; 13; 10; 6; 6; 4; 8; 13; 10; 13; 10; 10; 28; 10; 10 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; 1/2.2mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 50114-0110_cdc6114c-1b6f-4329-a612-fdc1535b6c06 50114-0110 HUMAN OTC DRUG Solidago Compositum SOLIDAGO VIRGAUREA FLOWERING TOP and BAPTISIA TINCTORIA ROOT and BERBERIS VULGARIS ROOT BARK and EQUISETUM HYEMALE and SILVER NITRATE and LYTTA VESICATORIA and CAPSICUM and CUPRIC SULFATE and CLERODENDRANTHUS SPICATUS LEAF and CHONDRODENDRON TOMENTOSUM ROOT and SMILAX REGELII ROOT and TURPENTINE OIL and APIS MELLIFERA VENOM and AGATHOSMA BETULINA LEAF and HUMAN COXSACKIEVIRUS A and MERCURIC CHLORIDE and SUS SCROFA URINARY BLADDER and CALCIUM SULFIDE and SODIUM PYRUVATE SOLUTION ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc AGATHOSMA BETULINA LEAF; APIS MELLIFERA VENOM; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CAPSICUM; CHONDRODENDRON TOMENTOSUM ROOT; CLERODENDRANTHUS SPICATUS LEAF; CUPRIC SULFATE; EQUISETUM HYEMALE; ESCHERICHIA COLI; HUMAN COXSACKIEVIRUS A; LYTTA VESICATORIA; MERCURIC CHLORIDE; SILVER NITRATE; SMILAX REGELII ROOT; SODIUM PYRUVATE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA URETHRA; SUS SCROFA URINARY BLADDER; TURPENTINE OIL 8; 8; 28; 4; 4; 10; 6; 6; 6; 6; 4; 13; 8; 6; 8; 6; 6; 10; 3; 10; 10; 10; 8; 6 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL 50114-0114_0c8c5c4e-cff5-4535-bea1-24097e05dca2 50114-0114 HUMAN OTC DRUG Oculoheel COCHLEARIA OFFICINALIS FLOWERING TOP,ECHINACEA ANGUSTIFOLIA,EUPHRASIA STRICTA and PILOCARPUS JABORANDI LEAF SOLUTION/ DROPS INTRAOCULAR 20050627 UNAPPROVED HOMEOPATHIC Heel Inc COCHLEARIA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; PILOCARPUS JABORANDI LEAF 5; 5; 5; 5 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL 50114-0150_4909468e-b84e-400c-b887-aa109b557817 50114-0150 HUMAN OTC DRUG Luffeel GALPHIMIA GLAUCA FLOWERING TOP and HISTAMINE DIHYDROCHLORIDE and LUFFA OPERCULATA FRUIT and SULFUR SPRAY NASAL 20110705 UNAPPROVED HOMEOPATHIC Heel Inc GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; SULFUR 4; 12; 4; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL 50114-0227_f9640e72-eb44-4bbb-91be-20d02fa1ab42 50114-0227 HUMAN PRESCRIPTION DRUG Atropinum Compositum Rx ATROPINE SULFATE and BRYONIA ALBA ROOT and ARSENIC TRIOXIDE and BERBERIS VULGARIS ROOT BARK and CITRULLUS COLOCYNTHIS FRUIT PULP and CUPRIC ACETATE and CHONDRODENDRON TOMENTOSUM ROOT and VERATRUM ALBUM ROOT and BAPTISIA TINCTORIA ROOT and CHELIDONIUM MAJUS and LYTTA VESICATORIA and GONORRHEAL URETHRAL SECRETION HUMAN and CLEMATIS RECTA FLOWERING TOP and THUJA OCCIDENTALIS LEAFY TWIG and BENZOIC ACID and SILVER NITRATE TABLET ORAL 20030830 UNAPPROVED HOMEOPATHIC Heel Inc ARSENIC TRIOXIDE; ATROPINE SULFATE; BAPTISIA TINCTORIA ROOT; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CHONDRODENDRON TOMENTOSUM ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CLEMATIS RECTA FLOWERING TOP; CUPRIC ACETATE; GONORRHEAL URETHRAL SECRETION HUMAN; LYTTA VESICATORIA; SILVER NITRATE; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT 4; 4; 1; 2; 1; 1; 1; 1; 1; 1; 2; 10; 5; 1; 1; 1 [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] 50114-0988_66ed1dc7-06bc-4292-91c1-5d63a842a6d6 50114-0988 HUMAN OTC DRUG Anacardium Homaccord SEMECARPUS ANACARDIUM JUICE and IODINE and IPECAC LIQUID ORAL 19860131 UNAPPROVED HOMEOPATHIC Heel Inc IODINE; IPECAC; SEMECARPUS ANACARDIUM JUICE 30; 4; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 50114-1034_09634e10-341d-491a-838c-4c2c09b1e193 50114-1034 HUMAN OTC DRUG Colocynthis-Homaccord CITRULLUS COLOCYNTHIS FRUIT PULP and PSEUDOGNAPHALIUM OBTUSIFOLIUM SOLUTION ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc CITRULLUS COLOCYNTHIS FRUIT PULP; PSEUDOGNAPHALIUM OBTUSIFOLIUM 4; 3 [hp_X]/1.1mL; [hp_X]/1.1mL 50114-1064_b2390d81-eca1-41f3-b593-0684f80e5f26 50114-1064 HUMAN OTC DRUG Euphorbium Compositum PULSATILLA VULGARIS and EUPHORBIA RESINIFERA RESIN and LUFFA OPERCULATA FRUIT and MERCURIC IODIDE and SUS SCROFA NASAL MUCOSA and SILVER NITRATE and CALCIUM SULFIDE and SINUSITISINUM SOLUTION ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc CALCIUM SULFIDE; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; PULSATILLA VULGARIS; SILVER NITRATE; SINUSITISINUM; SUS SCROFA NASAL MUCOSA 10; 4; 6; 8; 2; 10; 13; 8 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL 50114-1072_109538d2-62e1-41f3-8507-ed4ce49fdbd8 50114-1072 HUMAN OTC DRUG Neuralgo-Rheum PSEUDOGNAPHALIUM OBTUSIFOLIUM and CAUSTICUM and COLCHICUM AUTUMNALE BULB and CITRULLUS COLOCYNTHIS FRUIT PULP and IRON and LITHIUM BENZOATE and TOXICODENDRON PUBESCENS LEAF and FILIPENDULA ULMARIA ROO TABLET ORAL 20030830 UNAPPROVED HOMEOPATHIC Heel Inc CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; FILIPENDULA ULMARIA ROOT; IRON; LITHIUM BENZOATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 6; 10 [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg 50114-1075_a05a3b66-3e1a-4453-82a4-34b178720003 50114-1075 HUMAN OTC DRUG Hormeel AQUILEGIA VULGARIS and ORIGANUM MAJORANA WHOLE and NITRIC ACID and NUTMEG and OYSTER SHELL CALCIUM CARBONATE, CRUDE and CYPRIPEDIUM PARVIFOLUM ROOT and CONYZA CANADENSIS and CAPSELLA BURSA-PASTORIS and VIBURNUM OPULUS BARK and CYCLAMEN PURPURASCENS TUBER and PULSATILLA VULGARIS and SEPIA OFFICINALIS JUICE and STRYCHNOS IGNATII SEED and MOSCHUS MOSCHIFERUS MUSK SAC RESIN LIQUID ORAL 19951120 UNAPPROVED HOMEOPATHIC Heel Inc AQUILEGIA VULGARIS; CAPSELLA BURSA-PASTORIS; CONYZA CANADENSIS; CYCLAMEN PURPURASCENS TUBER; CYPRIPEDIUM PARVIFOLUM ROOT; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; NITRIC ACID; NUTMEG; ORIGANUM MAJORANA WHOLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; VIBURNUM OPULUS BARK 4; 3; 3; 4; 8; 6; 6; 6; 4; 8; 4; 4; 6; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 50114-1103_3cb12ff9-56a5-4bb6-9df6-2278c62350f5 50114-1103 HUMAN OTC DRUG Pulsatilla Compositum PULSATILLA VULGARIS and SULFUR and CORTISONE ACETATE TABLET ORAL 20030831 UNAPPROVED HOMEOPATHIC Heel Inc CORTISONE ACETATE; PULSATILLA VULGARIS; SULFUR 18; 6; 8 [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg 50114-1122_a0de0250-3466-42e8-94bb-f457d3125a56 50114-1122 HUMAN PRESCRIPTION DRUG Vertigoheel ANAMIRTA COCCULUS SEED, CONIUM MACULATUM FLOWERING TOP, AMBERGRIS, KEROSENE SOLUTION ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc AMBERGRIS; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; KEROSENE 5; 3; 2; 7 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL 50114-1124_f27946df-02a9-4d61-9411-7a65a2740625 50114-1124 HUMAN PRESCRIPTION DRUG Cactus Compositum PRUNUS SPINOSA FLOWER BUD and NITROGLYCERIN and SELENICEREUS GRANDIFLORUS STEM and POTASSIUM CARBONATE and SPIGELIA ANTHELMIA LIQUID ORAL 19860131 UNAPPROVED HOMEOPATHIC Heel Inc NITROGLYCERIN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA 6; 3; 1; 3; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 50114-1136_1badd765-06a6-4018-bf68-689ce1471573 50114-1136 HUMAN OTC DRUG Tonico-Heel STRYCHNOS NUX-VOMICA SEED and POTASSIUM PHOSPHATE, DIBASIC and GOLD and QUININE ARSENITE and CHAMAELIRIUM LUTEUM ROOT and HYPERICUM PERFORATUM and SELENIUM TABLET ORAL 20030831 UNAPPROVED HOMEOPATHIC Heel Inc CHAMAELIRIUM LUTEUM ROOT; GOLD; HYPERICUM PERFORATUM; POTASSIUM PHOSPHATE, DIBASIC; QUININE ARSENITE; SELENIUM; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10 [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg 50114-1144_20a55aa6-f2f4-46a4-b122-932d10b82c6f 50114-1144 HUMAN PRESCRIPTION DRUG Strumeel Forte Rx Oral Drops SPONGIA OFFICINALIS SKELETON, ROASTED and CALCIUM IODIDE and FUCUS VESICULOSUS and SILICON DIOXIDE and LIQUID ORAL 19860131 UNAPPROVED HOMEOPATHIC Heel Inc CALCIUM IODIDE; FUCUS VESICULOSUS; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED 3; 3; 8; 2 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 50114-1165_9f8cf8e1-df0f-43c5-ad97-f3ae07f5c127 50114-1165 HUMAN OTC DRUG Valerianaheel VALERIAN and TRINITROPHENOL and PRUNUS SPINOSA FLOWER BUD and HOPS and HYPERICUM PERFORATUM and MELISSA OFFICINALIS and AVENA SATIVA FLOWERING TOP and MATRICARIA RECUTITA and AMMONIUM BROMIDE and POTASSIUM BROMIDE and SODIUM BROMIDE LIQUID ORAL 19860131 UNAPPROVED HOMEOPATHIC Heel Inc AMMONIUM BROMIDE; AVENA SATIVA FLOWERING TOP; HOPS; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MELISSA OFFICINALIS; POTASSIUM BROMIDE; PRUNUS SPINOSA FLOWER BUD; SODIUM BROMIDE; TRINITROPHENOL; VALERIAN 2; 2; 2; 3; 2; 2; 2; 2; 2; 6; 2 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mm/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 50114-1180_41a60a07-207f-4722-9820-216654d9783e 50114-1180 HUMAN OTC DRUG Aconitum Homaccord ACONITUM NAPELLUS and EUCALYPTUS GLOBULUS LEAF and IPECAC LIQUID ORAL 19860131 UNAPPROVED HOMEOPATHIC Heel Inc ACONITUM NAPELLUS; EUCALYPTUS GLOBULUS LEAF; IPECAC 3; 2; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 50114-1190_35e2c1a0-bc4e-4100-8601-089f787776ef 50114-1190 HUMAN OTC DRUG Apis Homaccord ANTIMONY POTASSIUM TARTRATE and APIS MELLIFERA VENOM and DRIMIA MARITIMA BULB and APIS MELLIFERA LIQUID ORAL 19860131 UNAPPROVED HOMEOPATHIC Heel Inc ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; APIS MELLIFERA VENOM; DRIMIA MARITIMA BULB 2; 2; 6; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 50114-1195_324d3aa7-9824-4513-95b0-c99042087325 50114-1195 HUMAN OTC DRUG Belladonna Homaccord ATROPA BELLADONNA and ECHINACEA, UNSPECIFIED LIQUID ORAL 19860131 UNAPPROVED HOMEOPATHIC Heel Inc ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED 3; 10 [hp_X]/50mL; [hp_X]/50mL 50114-1200_94b7a186-210f-48cc-8dad-8539436654ee 50114-1200 HUMAN OTC DRUG Berberis Homaccord BERBERIS VULGARIS ROOT BARK, CITRULLUS COLOCYNTHIS FRUIT PULP and VERATRUM ALBUM ROOT LIQUID ORAL 19860131 UNAPPROVED HOMEOPATHIC Heel Inc BERBERIS VULGARIS ROOT BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; VERATRUM ALBUM ROOT 2; 3; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 50114-1220_3d6e9e55-5ae5-4f69-ba6a-57a155791e23 50114-1220 HUMAN OTC DRUG Cimicifuga Homaccord BLACK COHOSH and STRONTIUM CARBONATE and LIQUID ORAL 19860131 UNAPPROVED HOMEOPATHIC Heel Inc BLACK COHOSH; STRONTIUM CARBONATE 2; 8 [hp_X]/50mL; [hp_X]/50mL 50114-1240_690149cb-640d-4081-8578-5aca37448aef 50114-1240 HUMAN OTC DRUG Drosera Homaccord DROSERA ROTUNDIFOLIA and CUPRIC ACETATE LIQUID ORAL 19860131 UNAPPROVED HOMEOPATHIC Heel Inc CUPRIC ACETATE; DROSERA ROTUNDIFOLIA 4; 2 [hp_X]/50mL; [hp_X]/50mL 50114-1286_31523564-5066-4384-b542-0b88ef17d1de 50114-1286 HUMAN OTC DRUG Histamin HISTAMINE DIHYDROCHLORIDE SOLUTION ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc HISTAMINE DIHYDROCHLORIDE 12 [hp_X]/1.1mL 50114-1315_9e223897-12c4-4f11-bf6e-cbe8f63ae107 50114-1315 HUMAN OTC DRUG Sabal Homaccord SAW PALMETTO and CALCIUM SULFIDE LIQUID ORAL 19860131 UNAPPROVED HOMEOPATHIC Heel Inc CALCIUM SULFIDE; SAW PALMETTO 10; 1 [hp_X]/50mL; [hp_X]/50mL 50114-2282_24092235-dee0-4951-96f9-7fa909b0f35a 50114-2282 HUMAN OTC DRUG BHI Cold PULSATILLA VULGARIS and SULFUR TABLET ORAL 19840131 UNAPPROVED HOMEOPATHIC Heel Inc PULSATILLA VULGARIS; SULFUR 6; 8 [hp_X]/1; [hp_X]/1 50114-2324_3d4d14ec-27ac-4b6e-bcba-969ae79f6e1c 50114-2324 HUMAN OTC DRUG BHI Arthritis ANTIMONY POTASSIUM TARTRATE, ATROPA BELLADONNA , BLATTA ORIENTALIS, BRYONIA ALBA WHOLE, ANEMONE AMERICANA, STAR ANISE, IPECAC, LOBELIA INFLATA, NAPHTHALENE, SODIUM SULFATE, ASPIDOSPERMA QUEBRACHO-BLANCO BARK, and STACHYS OFFICINALIS TABLET ORAL 20000930 UNAPPROVED HOMEOPATHIC Heel Inc ANEMONE AMERICANA; ANTIMONY POTASSIUM TARTRATE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; ATROPA BELLADONNA; BLATTA ORIENTALIS; BRYONIA ALBA WHOLE; IPECAC; LOBELIA INFLATA; NAPHTHALENE; SODIUM SULFATE; STACHYS OFFICINALIS; STAR ANISE 5; 6; 6; 6; 8; 8; 4; 5; 6; 6; 4; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 50114-2733_0b3c724d-f40d-42b9-bb66-7aa2cc7b7a26 50114-2733 HUMAN OTC DRUG Zeel SILICON DIOXIDE and COMFREY ROOT and ARNICA MONTANA ROOT and TOXICODENDRON PUBESCENS LEAF and SULFUR and SANGUINARIA CANADENSIS ROOT and SOLANUM DULCAMARA STEM and COENZYME A and NADIDE and SODIUM DIETHYL OXALACETATE and .ALPHA.-LIPOIC ACID and SUS SCROFA CARTILAGE and SUS SCROFA EMBRYO and SUS SCROFA UMBILICAL CORD and SUS SCROFA PLACENTA and OINTMENT TOPICAL 20111020 UNAPPROVED HOMEOPATHIC Heel Inc .ALPHA.-LIPOIC ACID; ARNICA MONTANA ROOT; COENZYME A; COMFREY ROOT; NADIDE; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SOLANUM DULCAMARA STEM; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF 6; 2; 6; 8; 6; 2; 6; 6; 2; 6; 2; 2; 2; 2; 2 [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g 50114-3205_3e28a4e0-73f2-4f5a-8938-9ea64f060d2a 50114-3205 HUMAN OTC DRUG Naso-Heel GOLDENSEAL and LOBARIA PULMONARIA and POTASSIUM DICHROMATE and PHOSPHORUS and MERCURIC SULFIDE and AMMONIUM CARBONATE and LEMNA MINOR and ARUM MACULATUM ROOT and MERCURIC IODIDE LIQUID ORAL 19860131 UNAPPROVED HOMEOPATHIC Heel Inc AMMONIUM CARBONATE; ARUM MACULATUM ROOT; GOLDENSEAL; LEMNA MINOR; LOBARIA PULMONARIA; MERCURIC IODIDE; MERCURIC SULFIDE; PHOSPHORUS; POTASSIUM DICHROMATE 3; 4; 4; 3; 4; 8; 8; 6; 5 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 50114-3250_d13fa4ba-b63a-41ef-aaae-7636eeba7e8d 50114-3250 HUMAN OTC DRUG Sinusin PULSATILLA VULGARIS and EUPHORBIA RESINIFERA RESIN and LUFFA OPERCULATA FRUIT and MERCURIC IODIDE and SILVER NITRATE and CALCIUM SULFIDE and SINUSITISINUM and INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) LIQUID ORAL 20070131 UNAPPROVED HOMEOPATHIC Heel Inc CALCIUM SULFIDE; EUPHORBIA RESINIFERA RESIN; INFLUENZA A VIRUS A/BEIJING/32/92 (H3N2) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED); INFLUENZA B VIRUS B/PANAMA/45/90 HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED); LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; PULSATILLA VULGARIS; SILVER NITRATE; SINUSITISINUM 10; 6; 8; 8; 8; 6; 6; 2; 10; 13 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 50114-3353_b5d83682-c7e4-4a53-87b1-e087f3660fe9 50114-3353 HUMAN OTC DRUG Zeel SILICON DIOXIDE and COMFREY ROOT and ARNICA MONTANA ROOT and TOXICODENDRON PUBESCENS LEAF and SULFUR and SANGUINARIA CANADENSIS ROOT and SOLANUM DULCAMARA STEM and COENZYME A and NADIDE and SODIUM DIE OINTMENT TOPICAL 20111027 UNAPPROVED HOMEOPATHIC Heel Inc .ALPHA.-LIPOIC ACID; ARNICA MONTANA ROOT; COENZYME A; COMFREY ROOT; NADIDE; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SOLANUM DULCAMARA STEM; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF 6; 2; 6; 8; 6; 2; 6; 6; 2; 6; 2; 2; 2; 2; 2 [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g 50114-4041_5c5ba4a8-1b1e-4171-a003-c7eef86e5c05 50114-4041 HUMAN PRESCRIPTION DRUG Discus Compositum Rx PSEUDOGNAPHALIUM OBTUSIFOLIUM and BERBERIS VULGARIS ROOT BARK and BLACK COHOSH and CINCHONA OFFICINALIS BARK and CITRULLUS COLOCYNTHIS FRUIT PULP and LEDUM PALUSTRE TWIG and RANUNCULUS BULBOSUS and HORSE CHESTNUT and ASCORBIC ACID and CUPRIC ACETATE and POTASSIUM CARBONATE and NADIDE and SODIUM DIETHYL OXALACETATE and NIACINAMIDE and TRINITROPHENOL and PULSATILLA VULGARIS and PYRIDOXINE HYDROCHLORIDE and RIBOFLAVIN and CLAVICEPS PURPUREA SCLEROTIUM and SILICON DIOXIDE TABLET ORAL 20080830 UNAPPROVED HOMEOPATHIC Heel Inc .ALPHA.-LIPOIC ACID; AMMONIUM CHLORIDE; ASCORBIC ACID; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CLAVICEPS PURPUREA SCLEROTIUM; COENZYME A; CUPRIC ACETATE; GONORRHEAL URETHRAL SECRETION HUMAN; HORSE CHESTNUT; LEDUM PALUSTRE TWIG; MERCURIC OXIDE, YELLOW; NADIDE; NIACINAMIDE; POTASSIUM CARBONATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; RANUNCULUS BULBOSUS; RIBOFLAVIN; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA INTERVERTEBRAL DISC; SUS SCROFA UMBILICAL CORD; THIAMINE HYDROCHLORIDE; TRIBASIC CALCIUM PHOSPHATE; TRINITROPHENOL; ZINC 8; 8; 6; 4; 4; 4; 4; 6; 10; 6; 18; 6; 4; 10; 6; 6; 6; 3; 6; 6; 4; 6; 10; 6; 10; 6; 28; 10; 10; 8; 10; 8; 10; 6; 10; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 50114-4262_891a55df-7722-4dd6-b53f-4b5c5d4e0065 50114-4262 HUMAN OTC DRUG Back CITRULLUS COLOCYNTHIS FRUIT PULP and PSEUDOGNAPHALIUM OBTUSIFOLIUM and AMMONIUM CHLORIDE and GELSEMIUM SEMPERVIRENS ROOT and TOXICODENDRON PUBESCENS LEAF and ARSENIC TRIOXIDE and MATRICARIA RECUTITA and TABLET ORAL 20070830 UNAPPROVED HOMEOPATHIC Heel Inc. AMMONIUM CHLORIDE; ARSENIC TRIOXIDE; CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA RECUTITA; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF 6; 10; 5; 6; 10; 5; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 50114-4336_cee2557d-0f97-4299-87e9-de7b7d2175b5 50114-4336 HUMAN PRESCRIPTION DRUG Asthma Rx ARSENIC TRIOXIDE and ACTIVATED CHARCOAL and SULFUR TABLET ORAL 20111130 UNAPPROVED HOMEOPATHIC Heel Inc ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; SULFUR 12; 12; 12 [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg 50114-4338_278014c0-a9e7-4148-a9f8-7b1c1d0afb93 50114-4338 HUMAN OTC DRUG BHI Flu Plus ACONITUM NAPELLUS , CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, BRYONIA ALBA ROOT , EUPATORIUM PERFOLIATUM FLOWERING TOP, IPECAC, LACHESIS MUTA VENOM,PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, ZINC GLUCONATE, and ZINC TABLET ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc ACONITUM NAPELLUS; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; EUPATORIUM PERFOLIATUM FLOWERING TOP; IPECAC; LACHESIS MUTA VENOM; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; ZINC; ZINC GLUCONATE 4; 4; 200; 4; 6; 6; 8; 8; 8; 3; 3 [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 50114-4398_1533c5ea-84cb-4406-bdcf-a8622543f1c5 50114-4398 HUMAN PRESCRIPTION DRUG Uri-Cleanse Rx SOLIDAGO VIRGAUREA FLOWERING TOP and AMMI VISNAGA FRUIT and BERBERIS VULGARIS ROOT BARK and ANHYDROUS CITRIC ACID and CHONDRODENDRON TOMENTOSUM ROOT and LYTTA VESICATORIA and CALCIUM SULFIDE and NITRI TABLET ORAL 20111130 UNAPPROVED HOMEOPATHIC Heel Inc AMMI VISNAGA FRUIT; ANHYDROUS CITRIC ACID; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CHONDRODENDRON TOMENTOSUM ROOT; LYTTA VESICATORIA; MERCURIUS SOLUBILIS; NITRIC ACID; SOLIDAGO VIRGAUREA FLOWERING TOP 6; 6; 30; 6; 8; 6; 8; 10; 8; 4 [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 50114-4426_01a0c80e-4016-4cf7-b543-392ab1e7e4a3 50114-4426 HUMAN OTC DRUG Body Pure .ALPHA.-LIPOIC ACID and AVENA SATIVA FLOWERING TOP and RICINUS COMMUNIS SEED and SOLIDAGO VIRGAUREA FLOWERING TOP and VIOLA TRICOLOR and BERBERIS VULGARIS ROOT BARK and CAFFEINE and JUGLANS REGIA FLOWERING TOP and FRANGULA PURSHIANA BARK and URTICA URENS and CHOLESTEROL and INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) ANTIGEN (HEAT INACTIVATED) and KEROSENE and TOBACCO LEAF and ALCOHOL, X-RAY EXPOSED (1000 RAD) and STRYCHNOS NUX-VOMICA SEED TABLET ORAL 20070830 UNAPPROVED HOMEOPATHIC Heel Inc .ALPHA.-LIPOIC ACID; ALCOHOL, X-RAY EXPOSED (1000 RAD); AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CAFFEINE; CHOLESTEROL; FRANGULA PURSHIANA BARK; INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) ANTIGEN (HEAT INACTIVATED); JUGLANS REGIA FLOWERING TOP; KEROSENE; RICINUS COMMUNIS SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; URTICA URENS; VIOLA TRICOLOR 3; 12; 3; 6; 6; 10; 6; 12; 6; 12; 3; 4; 30; 12; 6; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_Q]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 50114-4500_092b7dd2-cfeb-4246-b80d-741e80977a20 50114-4500 HUMAN OTC DRUG Engystol CYNANCHUM VINCETOXICUM ROOT and SULFUR SOLUTION ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc CYNANCHUM VINCETOXICUM ROOT; SULFUR 6; 4 [hp_X]/1.1mL; [hp_X]/1.1mL 50114-5236_df693390-de95-46fa-a8fd-10b61ad7179e 50114-5236 HUMAN PRESCRIPTION DRUG Hormeel AQUILEGIA VULGARIS and ORIGANUM MAJORANA and NUTMEG and OYSTER SHELL CALCIUM CARBONATE, CRUDE and CONYZA CANADENSIS and VIBURNUM OPULUS BARK and CYCLAMEN PURPURASCENS TUBER and NITRIC ACID and PULSATI SOLUTION ORAL 20110808 UNAPPROVED HOMEOPATHIC Heel Inc AQUILEGIA VULGARIS; CONYZA CANADENSIS; CYCLAMEN PURPURASCENS TUBER; NITRIC ACID; NUTMEG; ORIGANUM MAJORANA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; VIBURNUM OPULUS BARK 4; 3; 4; 4; 6; 4; 8; 4; 6; 6; 3 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 50114-5324_6bd1d376-97d2-4876-96e6-31c7ad4903cb 50114-5324 HUMAN PRESCRIPTION DRUG Psorinoheel SULFUR, THUJA OCCIDENTALIS LEAFY TWIG, VACCINIA VIRUS STRAIN NEW YORK CITY BOARD, GONORRHEAL URETHRAL SECRETION HUMAN,SODIUM CHLORIDE, NERIUM OLEANDER LEAF,CICUTA VIROSA ROOT, SOLUTION ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc BUFO BUFO CUTANEOUS GLAND; CICUTA VIROSA ROOT; GONORRHEAL URETHRAL SECRETION HUMAN; NERIUM OLEANDER LEAF; POTASSIUM DICHROMATE; SCABIES LESION LYSATE (HUMAN); SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN 10; 5; 12; 4; 5; 10; 6; 6; 8 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL Live Vaccinia Virus Vaccine [EPC],Actively Acquired Immunity [PE],Smallpox Vaccine [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient] 50114-5325_daa2eb07-023b-4582-a037-4f21aa8a7c25 50114-5325 HUMAN OTC DRUG Selenium Homaccord POTASSIUM PHOSPHATE, DIBASIC and SELENIUM SOLUTION ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc POTASSIUM PHOSPHATE, DIBASIC; SELENIUM 6; 10 [hp_X]/1.1mL; [hp_X]/1.1mL 50114-5347_47aecf25-2b96-4664-b1ce-33a9dc9d5cb2 50114-5347 HUMAN OTC DRUG Sinusin PULSATILLA VULGARIS and EUPHORBIA RESINIFERA RESIN and LUFFA OPSILVER NITRATEERCULATA FRUIT and MERCURIC IODIDE and SUS SCROFA NASAL MUCOSA and SILVER NITRATE and CALCIUM SULFIDE and SINUSITISINUM SOLUTION ORAL 20110706 UNAPPROVED HOMEOPATHIC Heel Inc CALCIUM SULFIDE; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; PULSATILLA VULGARIS; SILVER NITRATE; SINUSITISINUM; SUS SCROFA NASAL MUCOSA 10; 4; 6; 8; 2; 10; 13; 8 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL 50114-5356_157787ba-2117-40bc-9d59-5c99dd0787c7 50114-5356 HUMAN OTC DRUG Thuja THUJA OCCIDENTALIS LEAFY TWIG SOLUTION ORAL 20100301 UNAPPROVED HOMEOPATHIC Heel Inc THUJA OCCIDENTALIS LEAFY TWIG 12 [hp_X]/1.1mL 50114-5360_92eb1892-35e4-485d-9786-c5152fadb7b4 50114-5360 HUMAN OTC DRUG Tonico-Heel STRYCHNOS NUX-VOMICA SEED and POTASSIUM PHOSPHATE, DIBASIC and GOLD and QUININE ARSENITE and CHAMAELIRIUM LUTEUM ROOT and HYPERICUM PERFORATUM and SELENIUM SOLUTION ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc CHAMAELIRIUM LUTEUM ROOT; GOLD; HYPERICUM PERFORATUM; POTASSIUM PHOSPHATE, DIBASIC; QUININE ARSENITE; SELENIUM; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL 50114-6005_54c1fa68-605f-40d8-826d-2872f6131e6b 50114-6005 HUMAN OTC DRUG Aletris - Heel SEPIA OFFICINALIS JUICE and ALETRIS FARINOSA ROOT and ANAMIRTA COCCULUS SEED and CHAMAELIRIUM LUTEUM ROOT and POTASSIUM CARBONATE and SODIUM CHLORIDE and QUININE ARSENATE and PICRIC ACID and TABLET ORAL 19840131 UNAPPROVED HOMEOPATHIC Heel Inc ALETRIS FARINOSA ROOT; ANAMIRTA COCCULUS SEED; CHAMAELIRIUM LUTEUM ROOT; PICRIC ACID; POTASSIUM CARBONATE; QUININE ARSENATE; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE 4; 4; 4; 6; 4; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 50114-6010_4987c63e-5aec-4505-b795-21debcdd2637 50114-6010 HUMAN OTC DRUG Apis compositum TURPENTINE OIL and NUTMEG and APIS MELLIFERA and STRYCHNOS IGNATII SEED and VERATRUM ALBUM ROOT and PHOSPHORUS and MERCURIC CHLORIDE TABLET ORAL 19840131 UNAPPROVED HOMEOPATHIC Heel Inc. APIS MELLIFERA; MERCURIC CHLORIDE; NUTMEG; PHOSPHORUS; STRYCHNOS IGNATII SEED; TURPENTINE OIL; VERATRUM ALBUM ROOT 4; 8; 6; 6; 4; 6; 4 [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg 50114-6085_fb7148f6-313c-4225-b4f4-9230c6c6690a 50114-6085 HUMAN OTC DRUG Klimaktheel LACHESIS MUTA VENOM and TIN and SANGUINARIA CANADENSIS ROOT and SIMABA CEDRON SEED and STRYCHNOS IGNATII SEED and SEPIA OFFICINALIS JUICE and SULFUR TABLET ORAL 19840131 UNAPPROVED HOMEOPATHIC Heel Inc LACHESIS MUTA VENOM; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SIMABA CEDRON SEED; STRYCHNOS IGNATII SEED; SULFUR; TIN 12; 3; 4; 4; 4; 4; 12 [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg 50114-6110_eeb47dac-a7c9-4559-93b0-2798b2a7cf47 50114-6110 HUMAN OTC DRUG Oculoheel SPIGELIA ANTHELMIA and CALCIUM SULFIDE and TOXICODENDRON PUBESCENS LEAF and DELPHINIUM STAPHISAGRIA SEED and APIS MELLIFERA and SODIUM CHLORIDE and MERCURIC SULFIDE TABLET ORAL 19840131 UNAPPROVED HOMEOPATHIC Heel Inc APIS MELLIFERA; CALCIUM SULFIDE; DELPHINIUM STAPHISAGRIA SEED; MERCURIC SULFIDE; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; TOXICODENDRON PUBESCENS LEAF 4; 12; 4; 8; 6; 6; 12 [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg 50114-6129_eab7b089-635c-472d-a952-8ad4f063ae0c 50114-6129 HUMAN OTC DRUG Spascupreel ACONITUM NAPELLUS and AMMONIUM BROMIDE and CITRULLUS COLOCYNTHIS FRUIT PULP and ATROPINE SULFATE and GELSEMIUM SEMPERVIRENS ROOT and MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE and VERATRUM ALBUM ROOT and PASSIFLORA INCARNATA FLOWERING TOP and MATRICARIA RECUTITA and AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY and CUPRIC SULFATE SOLUTION ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMMONIUM BROMIDE; ATROPINE SULFATE; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC SULFATE; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VERATRUM ALBUM ROOT 6; 4; 4; 6; 4; 6; 6; 6; 3; 2; 6 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL 50114-6134_0183c6a7-6195-451c-9eef-81d60c769d4f 50114-6134 HUMAN OTC DRUG Abropernol ARTEMISIA ABROTANUM FLOWERING TOP and PULSATILLA VULGARIS and CALCIUM FLUORIDE and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK and AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY and NITRIC ACID and KEROSEN TABLET ORAL 19840131 UNAPPROVED HOMEOPATHIC Heel Inc AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARTEMISIA ABROTANUM FLOWERING TOP; CALCIUM FLUORIDE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; KEROSENE; NITRIC ACID; PULSATILLA VULGARIS 5; 4; 12; 4; 6; 6; 4 [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg 50114-6141_8c1438b4-65d2-4dcf-b23d-9b495f7efa89 50114-6141 HUMAN OTC DRUG Coenzyme Compositum BETA VULGARIS and ASCORBIC ACID and CYSTEINE and MAGNESIUM OROTATE and MANGANESE PHOSPHATE, DIBASIC and SODIUM DIETHYL OXALACETATE and NIACINAMIDE and PULSATILLA VULGARIS and PYRIDOXINE HYDROCHLORIDE and RIBOFLAVIN and THIAMINE HYDROCHLORIDE and .ALPHA.-LIPOIC ACID and .ALPHA.-KETOGLUTARIC ACID and CEROUS OXALATE NONAHYDRATE and ACONITIC ACID, (Z)- and ANHYDROUS CITRIC ACID and COENZYME A and FUMARIC ACID and MALIC ACID and NADIDE and SODIUM PYRUVATE and SUCCINIC ACID TABLET ORAL 20030831 UNAPPROVED HOMEOPATHIC Heel Inc .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ACONITIC ACID, (Z)-; ADENOSINE TRIPHOSPHATE; ANHYDROUS CITRIC ACID; ASCORBIC ACID; BARIUM OXALOSUCCINATE; BETA VULGARIS; CALCIUM SULFIDE; CEROUS OXALATE NONAHYDRATE; COENZYME A; CYSTEINE; FUMARIC ACID; MAGNESIUM OROTATE; MALIC ACID; MANGANESE PHOSPHATE, DIBASIC; NADIDE; NIACINAMIDE; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SULFUR; THIAMINE HYDROCHLORIDE 8; 6; 8; 10; 8; 6; 10; 4; 10; 8; 8; 6; 8; 6; 8; 6; 8; 6; 6; 6; 6; 6; 8; 8; 10; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 50114-6150_593a232e-307d-43f2-83fd-237c8a1b91fe 50114-6150 HUMAN OTC DRUG Traumeel ACONITUM NAPELLUS, ARNICA MONTANA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, CHAMOMILE, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALCIUM SULFIDE, HYPERICUM PERFORATUM, MERCURIUS SOLUBILIS, ACHILLEA MILLEFOLIUM and COMFREY ROOT TABLET ORAL 19840131 UNAPPROVED HOMEOPATHIC Heel Inc. ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MERCURIUS SOLUBILIS 3; 3; 3; 4; 2; 8; 2; 3; 8; 2; 2; 2; 3; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 50114-6175_8d0530f2-eec6-456a-a185-96b638d576f6 50114-6175 HUMAN PRESCRIPTION DRUG Syzygium Compositum STRYCHNOS IGNATII SEED and TRINITROPHENOL and LYCOPODIUM CLAVATUM SPORE and PHOSPHORIC ACID and LACTIC ACID, L- and WOOD CREOSOTE and CLAVICEPS PURPUREA SCLEROTIUM and ARSENIC TRIOXIDE and TUBOCURARIN LIQUID ORAL 19860131 UNAPPROVED HOMEOPATHIC Heel Inc .ALPHA.-KETOGLUTARIC ACID; ARSENIC TRIOXIDE; CLAVICEPS PURPUREA SCLEROTIUM; LACTIC ACID, L-; LEAD; LYCOPODIUM CLAVATUM SPORE; PHLORIZIN; PHOSPHORIC ACID; PORK LIVER; SODIUM SULFATE; STRYCHNOS IGNATII SEED; SULFURIC ACID; SUS SCROFA PANCREAS; SYZYGIUM CUMINI SEED; TRINITROPHENOL; TUBOCURARINE CHLORIDE; WOOD CREOSOTE 8; 8; 6; 4; 18; 4; 10; 4; 10; 10; 4; 8; 10; 8; 4; 8; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 50114-6186_9d477bb4-ef94-477f-9ae1-2ad2a25cd4d0 50114-6186 HUMAN OTC DRUG Aesculus-Heel HORSE CHESTNUT LIQUID ORAL 19860131 UNAPPROVED HOMEOPATHIC Heel Inc HORSE CHESTNUT 2 [hp_X]/50mL 50114-6922_f5e8083a-dccf-4b62-b5b4-6060e12c3f3e 50114-6922 HUMAN PRESCRIPTION DRUG BHI Mucus ANTIMONY POTASSIUM TARTRATE,ATROPA BELLADONNA,BRYONIA ALBA ROOT,ANEMONE AMERICANA,HYOSCYAMUS NIGER,IPECAC,LOBELIA INFLATA,HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED, and LOBARIA PULMONARIA TABLET ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc ANEMONE AMERICANA; ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; HYOSCYAMUS NIGER; IPECAC; LOBARIA PULMONARIA; LOBELIA INFLATA 6; 5; 6; 6; 30; 5; 6; 5; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 50114-7001_216696dc-2fbb-49b8-a10d-065a18fd36e7 50114-7001 HUMAN OTC DRUG Gripp-Heel ACONITUM NAPELLUS and BRYONIA ALBA ROOT and LACHESIS MUTA VENOM and EUPATORIUM PERFOLIATUM FLOWERING TOP and PHOSPHORUS SOLUTION ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; LACHESIS MUTA VENOM; PHOSPHORUS 3; 3; 2; 11; 4 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL 50114-7004_136863f3-676d-4ef7-829d-65cf1236bc26 50114-7004 HUMAN PRESCRIPTION DRUG Traumeel ARNICA MONTANA ROOT, ATROPA BELLADONNA, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ACHILLEA MILLEFOLIUM, CALCIUM SULFIDE, COMFREY ROOT, ACONITUM NAPELLUS, BELLIS PERENNIS, MERCURIUS SOLUBILIS, HYPERICUM PERFORATUM, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK INJECTION INTRA-ARTICULAR; INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20070509 UNAPPROVED HOMEOPATHIC Medinatura ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS 3; 2; 2; 2; 2; 6; 2; 6; 2; 2; 1; 2; 3; 6 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL 50114-7015_8c18de8f-8d45-474e-8fca-38ce5fbcf93d 50114-7015 HUMAN PRESCRIPTION DRUG Engystol CYNANCHUM VINCETOXICUM ROOT and SULFUR INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110706 UNAPPROVED HOMEOPATHIC MediNatura CYNANCHUM VINCETOXICUM ROOT; SULFUR 6; 4 [hp_X]/1.1mL; [hp_X]/1.1mL 50114-7026_0267a3c4-bfd9-450c-8321-0cf93e33e8e5 50114-7026 HUMAN PRESCRIPTION DRUG Lymphomyosot GERANIUM ROBERTIANUM, NASTURTIUM OFFICINALE, FERROUS IODIDE, JUGLANS REGIA LEAF, JUGLANS REGIA FRUIT RIND, IMMATURE, MYOSOTIS ARVENSIS, SCROPHULARIA NODOSA, TEUCRIUM SCORODONIA FLOWERING TOP, VERONICA OFFICINALIS FLOWERING TOP, EQUISETUM HYEMALE, FUMARIA OFFICINALIS FLOWERING TOP, SODIUM SULFATE, PINUS SYLVESTRIS FLOWERING TOP,GENTIANA LUTEA ROOT, ARANEUS DIADEMATUS, SMILAX REGELII ROOT, TRIBASIC CALCIUM PHOSPHATE and LEVOTHYROXINE INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100401 UNAPPROVED HOMEOPATHIC Heel Inc ARANEUS DIADEMATUS; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; LEVOTHYROXINE; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; PINUS SYLVESTRIS FLOWERING TOP; SCROPHULARIA NODOSA; SMILAX REGELII ROOT; SODIUM SULFATE; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 6; 4; 12; 4; 5; 4; 3; 3; 12; 3; 4; 4; 3; 6; 4; 3; 12; 3 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 50114-7030_d4f4380b-4767-4b68-81d8-a3bd372daaba 50114-7030 HUMAN PRESCRIPTION DRUG Zeel ARNICA MONTANA ROOT, TOXICODENDRON PUBESCENS LEAF, SOLANUM DULCAMARA TOP, COMFREY ROOT, SULFUR, SANGUINARIA CANADENSIS ROOT, SUS SCROFA CARTILAGE, SUS SCROFA EMBRYO, SUS SCROFA UMBILICAL CORD, SUS SCROFA PLACENTA, .ALPHA.-LIPOIC ACID, COENZYME A, NADIDE and SODIUM DIETHYL OXALACETATE INJECTION INTRA-ARTICULAR; INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20040131 UNAPPROVED HOMEOPATHIC MediNatura .ALPHA.-LIPOIC ACID; ARNICA MONTANA ROOT; COENZYME A; COMFREY ROOT; NADIDE; SANGUINARIA CANADENSIS ROOT; SODIUM DIETHYL OXALACETATE; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF 8; 4; 8; 6; 8; 4; 8; 3; 6; 6; 6; 6; 6; 2 [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL 50114-7040_8373b6a5-b4b6-4782-b5c8-82de341e652c 50114-7040 HUMAN PRESCRIPTION DRUG Spascupreel ACONITUM NAPELLUS, AMMONIUM BROMIDE, CITRULLUS COLOCYNTHIS FRUIT PULP, ATROPINE SULFATE, GELSEMIUM SEMPERVIRENS ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, VERATRUM ALBUM ROOT, PASSIFLORA INCARNATA FLOWERING TOP, MATRICARIA RECUTITA, AMANITA MUSCARIA FRUITING BODY and CUPRIC SULFATE INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110120 UNAPPROVED HOMEOPATHIC MediNatura Inc ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; AMMONIUM BROMIDE; ATROPINE SULFATE; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC SULFATE; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VERATRUM ALBUM ROOT 6; 4; 4; 6; 4; 6; 6; 6; 3; 2; 6 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 50114-7041_b56ceb53-f812-40b1-967e-72a85d653e62 50114-7041 HUMAN PRESCRIPTION DRUG Thyreoidea Compositum LACTIC ACID, L- and VISCUM ALBUM and COLCHICUM AUTUMNALE BULB and CONIUM MACULATUM FLOWERING TOP and GALIUM APARINE and FUCUS VESICULOSUS and SEDUM ACRE and SEMPERVIVUM TECTORUM LEAF and ADENOSINE TRI INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110708 UNAPPROVED HOMEOPATHIC Heel Inc .ALPHA.-KETOGLUTARIC ACID; ADENOSINE TRIPHOSPHATE; CALCIUM FLUORIDE; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; FUCUS VESICULOSUS; FUMARIC ACID; GALIUM APARINE; LACTIC ACID, L-; MALIC ACID; PORK LIVER; PULSATILLA VULGARIS; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; SODIUM DIETHYL OXALACETATE; SPONGIA OFFICINALIS SKELETON, ROASTED; SULFUR; SUS SCROFA BONE MARROW; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; SUS SCROFA THYROID; SUS SCROFA UMBILICAL CORD; VISCUM ALBUM FRUIT 8; 8; 10; 4; 4; 28; 6; 8; 4; 3; 8; 10; 8; 6; 6; 8; 8; 10; 10; 10; 10; 8; 10; 3 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50114-7050_6741bea8-5d92-4f52-98f0-b65efa284cbf 50114-7050 HUMAN PRESCRIPTION DRUG Cutis Compositum LEDUM PALUSTRE TWIG and URTICA URENS and AESCULUS HIPPOCASTANUM FLOWER and GALIUM APARINE and STRYCHNOS IGNATII SEED and ARCTIUM LAPPA ROOT and PHOSPHORIC ACID and SUS SCROFA SKIN and THUJA OCCIDENTALIS LEAFY TWIG and FUMARIC ACID and SUS SCROFA UMBILICAL CORD and SUS SCROFA ADRENAL GLAND and PORK LIVER and .ALPHA.-KETOGLUTARIC ACID and SODIUM DIETHYL OXALACETATE and SUS SCROFA PLACENTA and SELENIUM and SUS SCROFA SPLEEN INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20090430 UNAPPROVED HOMEOPATHIC Heel Inc .ALPHA.-KETOGLUTARIC ACID; AESCULUS HIPPOCASTANUM FLOWER; ARCTIUM LAPPA ROOT; CALCIUM FLUORIDE; CORTISONE ACETATE; FORMIC ACID; FUMARIC ACID; GALIUM APARINE; ICHTHAMMOL; LEDUM PALUSTRE TWIG; MERCURIUS SOLUBILIS; PHOSPHORIC ACID; PORK LIVER; SELENIUM; SODIUM DIETHYL OXALACETATE; STRYCHNOS IGNATII SEED; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA PLACENTA; SUS SCROFA SKIN; SUS SCROFA SPLEEN; SUS SCROFA UMBILICAL CORD; THALLIUM SULFATE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 10; 6; 6; 13; 28; 198; 10; 6; 28; 4; 13; 6; 10; 10; 10; 6; 10; 10; 10; 8; 10; 10; 13; 8; 4 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 50114-7055_cc3f0e8b-fc8c-4a62-b3e7-d70b061977e4 50114-7055 HUMAN PRESCRIPTION DRUG Placenta Compositum HORSE CHESTNUT and LACTIC ACID, L- and CLAVICEPS PURPUREA SCLEROTIUM and CUPRIC SULFATE and MELILOTUS OFFICINALIS TOP and SUS SCROFA PLACENTA and SOLANUM NIGRUM WHOLE and STROPHANTHUS HISPIDUS SEED and SUS SCROFA EMBRYO and SODIUM PYRUVATE and SUS SCROFA VEIN and SUS SCROFA ARTERY and SUS SCROFA UMBILICAL CORD and TOBACCO LEAF and VIPERA BERUS VENOM and BARIUM CARBONATE and LEAD IODIDE INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20090430 UNAPPROVED HOMEOPATHIC Heel Inc BARIUM CARBONATE; CLAVICEPS PURPUREA SCLEROTIUM; CUPRIC SULFATE; HORSE CHESTNUT; LACTIC ACID, L-; LEAD IODIDE; MELILOTUS OFFICINALIS TOP; SODIUM PYRUVATE; SOLANUM NIGRUM WHOLE; STROPHANTHUS HISPIDUS SEED; SUS SCROFA ARTERY; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; SUS SCROFA VEIN; TOBACCO LEAF; VIPERA BERUS VENOM 13; 4; 6; 4; 4; 18; 6; 8; 6; 6; 10; 8; 6; 10; 8; 10; 10 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 50114-7060_eb4e6b30-2aab-451e-ad43-485323d7cbb6 50114-7060 HUMAN PRESCRIPTION DRUG Pulsatilla Compositum PULSATILLA VULGARIS and SULFUR and CORTISONE ACETATE INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20090430 UNAPPROVED HOMEOPATHIC Heel Inc CORTISONE ACETATE; PULSATILLA VULGARIS; SULFUR 18; 6; 8 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL 50114-7065_50d73c8c-91dd-4e2f-8182-3184787180c6 50114-7065 HUMAN PRESCRIPTION DRUG Colocynthis Homaccord PSEUDOGNAPHALIUM OBTUSIFOLIUM and CITRULLUS COLOCYNTHIS FRUIT PULP and INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20120511 UNAPPROVED HOMEOPATHIC Heel Inc CITRULLUS COLOCYNTHIS FRUIT PULP; PSEUDOGNAPHALIUM OBTUSIFOLIUM 4; 3 [hp_X]/1.1mL; [hp_X]/1.1mL 50114-7070_23855cff-afcb-492a-a772-ac83f4a37170 50114-7070 HUMAN PRESCRIPTION DRUG Neuralgo Rheum PSEUDOGNAPHALIUM OBTUSIFOLIUM, CAUSTICUM, COLCHICUM AUTUMNALE BULB, CITRULLUS COLOCYNTHIS FRUIT PULP, IRON, LITHIUM BENZOATE, TOXICODENDRON PUBESCENS LEAF and FILIPENDULA ULMARIA ROOT INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110708 UNAPPROVED HOMEOPATHIC Heel Inc CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; FILIPENDULA ULMARIA ROOT; IRON; LITHIUM BENZOATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 6; 10 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL Mood Stabilizer [EPC] 50114-7110_68dcd90d-95e7-41e1-b527-449af5f287ab 50114-7110 HUMAN PRESCRIPTION DRUG Traumeel ARNICA MONTANA ROOT and ATROPA BELLADONNA and ACONITUM NAPELLUS and HYPERICUM PERFORATUM and CALENDULA OFFICINALIS FLOWERING TOP and MATRICARIA RECUTITA and ACHILLEA MILLEFOLIUM and CALCIUM SULFIDE and COMFREY ROOT and BELLIS PERENNIS and MERCURIUS SOLUBILIS and ECHINACEA, UNSPECIFIED and ECHINACEA PURPUREA and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK SOLUTION/ DROPS ORAL 20020930 UNAPPROVED HOMEOPATHIC Heel Inc ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS 3; 3; 3; 3; 2; 6; 2; 6; 2; 2; 1; 3; 3; 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 50114-7120_a98f6768-07aa-496e-9d59-1346e9c4c2a8 50114-7120 HUMAN OTC DRUG Traumeel CALENDULA OFFICINALIS FLOWERING TOP and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK and ARNICA MONTANA ROOT and ACONITUM NAPELLUS and ATROPA BELLADONNA and BELLIS PERENNIS and MATRICARIA RECUTITA and ECHINACEA, UNSPECIFIED and ECHINACEA PURPUREA and ACHILLEA MILLEFOLIUM and CALCIUM SULFIDE and MERCURIUS SOLUBILIS and COMFREY ROOT and HYPERICUM PERFORATUM and OINTMENT TOPICAL 19861031 UNAPPROVED HOMEOPATHIC Heel Inc ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS 1; 3; 3; 3; 1; 8; 1; 4; 1; 1; 1; 6; 1; 8 [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g 50114-8010_8c6934cd-ce2c-4f28-931f-6ee4d9123530 50114-8010 HUMAN OTC DRUG Traumeel CALENDULA OFFICINALIS FLOWERING TOP and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK and ARNICA MONTANA ROOT and ACONITUM NAPELLUS and ATROPA BELLADONNA and BELLIS PERENNIS and MATRICARIA RECUTITA and ECH GEL TOPICAL 19991031 UNAPPROVED HOMEOPATHIC Heel Inc ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS 1; 3; 3; 3; 1; 8; 1; 4; 1; 1; 1; 6; 1; 8 [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g 50114-8015_1051dac8-cc5d-4223-b13b-eaddea62eee2 50114-8015 HUMAN OTC DRUG Traumeel CALENDULA OFFICINALIS FLOWERING TOP and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK and ARNICA MONTANA ROOT and ACONITUM NAPELLUS and ATROPA BELLADONNA and BELLIS PERENNIS and MATRICARIA RECUTITA and ECHINACEA, UNSPECIFIED and ECHINACEA PURPUREA and ACHILLEA MILLEFOLIUM and CALCIUM SULFIDE and MERCURIUS SOLUBILIS and COMFREY ROOT and HYPERICUM PERFORATUM and GEL TOPICAL 19991031 UNAPPROVED HOMEOPATHIC Heel Inc ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS 1; 3; 3; 3; 1; 8; 1; 4; 1; 1; 1; 6; 1; 8 [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g 50114-8110_7cb1e6c1-4bb8-4e74-b416-c9bd701eb0ce 50114-8110 HUMAN OTC DRUG Reboost APIS MELLIFERA and CYNANCHUM VINCETOXICUM LEAF and ATROPA BELLADONNA and CALENDULA OFFICINALIS FLOWERING TOP and ECHINACEA PURPUREA and PHYTOLACCA AMERICANA ROOT and PLANTAGO MAJOR and SAGE SPRAY ORAL 20130211 UNAPPROVED HOMEOPATHIC Heel Inc APIS MELLIFERA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; CYNANCHUM VINCETOXICUM LEAF; ECHINACEA PURPUREA; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; SAGE 7; 5; 3; 5; 5; 3; 3; 3 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL 50114-8200_b812671d-4129-4202-8cfd-b61bcddb73f9 50114-8200 HUMAN PRESCRIPTION DRUG Lymphomyosot X ARANEUS DIADEMATUS, TRIBASIC CALCIUM PHOSPHATE, EQUISETUM HYEMALE, FERROUS IODIDE,FUMARIA OFFICINALIS FLOWERING TOP, GENTIANA LUTEA ROOT, GERANIUM ROBERTIANUM, MYOSOTIS ARVENSIS, NASTURTIUM OFFICINALE, SODIUM SULFATE, PINUS SYLVESTRIS LEAFY TWIG,SMILAX REGELII ROOT, SCROPHULARIA NODOSA, TEUCRIUM SCORODONIA FLOWERING TOP, THYROID, UNSPECIFIED andVERONICA OFFICINALIS FLOWERING TOP INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100401 UNAPPROVED HOMEOPATHIC Heel Inc ARANEUS DIADEMATUS; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; PINUS SYLVESTRIS LEAFY TWIG; SCROPHULARIA NODOSA; SMILAX REGELII ROOT; SODIUM SULFATE; TEUCRIUM SCORODONIA FLOWERING TOP; THYROID, UNSPECIFIED; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 6; 12; 3; 4; 5; 4; 3; 4; 4; 3; 6; 4; 3; 12; 12; 3 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 50114-8500_074b7cbd-e267-4f99-a040-023f50375ef7 50114-8500 HUMAN OTC DRUG Vinceel APIS MELLIFERA and CYNANCHUM VINCETOXICUM LEAF and ATROPA BELLADONNA and CALENDULA OFFICINALIS FLOWERING TOP and ECHINACEA PURPUREA and PHYTOLACCA AMERICANA ROOT and PLANTAGO MAJOR and SAGE SPRAY ORAL 20060831 UNAPPROVED HOMEOPATHIC Heel Inc APIS MELLIFERA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; CYNANCHUM VINCETOXICUM LEAF; ECHINACEA PURPUREA; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; SAGE 7; 5; 3; 5; 5; 3; 3; 3 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL 50114-8502_c9019302-7070-4f1d-a9a3-e1a226b751ab 50114-8502 HUMAN OTC DRUG Traumeel Combo Pack Traumeel KIT 20120531 UNAPPROVED HOMEOPATHIC Heel Inc 50114-8505_b4f3752c-7700-473b-9939-c5fd9b890f39 50114-8505 HUMAN OTC DRUG Traumeel X Value Pack Traumeel KIT 20130812 UNAPPROVED HOMEOPATHIC Heel Inc 50114-8510_4081b17d-14e8-4aed-ab4e-8d962d417af6 50114-8510 HUMAN OTC DRUG Nectadyn DROSERA ROTUNDIFOLIA and IPECAC and RUMEX CRISPUS ROOT and ANTIMONY POTASSIUM TARTRATE and CUPRIC SULFATE and SPONGIA OFFICINALIS SKELETON, ROASTED SYRUP ORAL 20070831 UNAPPROVED HOMEOPATHIC Heel Inc ANTIMONY POTASSIUM TARTRATE; CUPRIC SULFATE; DROSERA ROTUNDIFOLIA; IPECAC; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 6; 4; 4; 4; 8 [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL 50114-8550_ba1d7b8e-0475-40f3-9fef-5b20fb600ec0 50114-8550 HUMAN OTC DRUG Reboost ANTIMONY POTASSIUM TARTRATE SYRUP ORAL 20130213 UNAPPROVED HOMEOPATHIC Heel Inc ANTIMONY POTASSIUM TARTRATE; CUPRIC SULFATE; DROSERA ROTUNDIFOLIA; IPECAC; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 6; 4; 4; 4; 8 [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL 50115-100_d26468a2-178b-4fd2-b653-3a35d00a0044 50115-100 HUMAN OTC DRUG Homeopathic Immunity Supporting Adjuvant Escherichia coli and Proteus vulgaris LIQUID ORAL 20091209 UNAPPROVED HOMEOPATHIC Ortas International Group S.A. ESCHERICHIA COLI; PROTEUS VULGARIS 6; 12 [hp_X]/1; [hp_X]/1 50115-200_b8b279fe-db3c-401f-8562-ff614b2b240d 50115-200 HUMAN OTC DRUG Homeopathic Immunity Supporting Tonic Escherichia coli, Proteus vulgaris, and Streptococcin LIQUID ORAL 20091209 UNAPPROVED HOMEOPATHIC Ortas International Group S.A. ESCHERICHIA COLI; PROTEUS VULGARIS; STREPTOCOCCUS PYOGENES 12; 12; 14 [hp_X]/1; [hp_X]/1; [hp_X]/1 50125-001_d7e65c45-74f4-45bc-bbba-3f30166aad4f 50125-001 HUMAN OTC DRUG Medessence Plus Homeopathic Nail Thuja Occidentalis, Antimonium Crudum SOLUTION TOPICAL 20090501 UNAPPROVED HOMEOPATHIC Deep Cover Systems LLC ANTIMONY TRISULFIDE; CINNAMON; DIOSCOREA VILLOSA EXTRACT; GRAPHITE; SILICON DIOXIDE; SODIUM BORATE; THUJA OCCIDENTALIS TWIG 10; 10; 10; 10; 10; 10; 10 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 50126-001_baedd638-9374-4eed-b58d-603f2aa310af 50126-001 HUMAN OTC DRUG Homeopathic Pediculicide Natrum Muriaticum SHAMPOO TOPICAL 20091020 UNAPPROVED HOMEOPATHIC Advanced Natural Solutions SODIUM CHLORIDE 6 [hp_X]/237mL 50130-316_5089eb28-fb10-4013-b683-e625d14c386b 50130-316 HUMAN OTC DRUG BIO-ICE MENTHOL, CAMPHOR GEL TOPICAL 20130101 OTC MONOGRAPH FINAL part341 Electrostim Medical Services Inc. d/b/a EMSI CAMPHOR (SYNTHETIC); MENTHOL .48; 5.4 g/100mL; g/100mL 50136-555_906cda44-1f0f-41fd-94d2-7ee341c85dda 50136-555 HUMAN OTC DRUG Hy5 Alcohol Free Benzalkonium Chloride LIQUID TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part333 MGS Brands, Inc. BENZALKONIUM CHLORIDE .13 L/100L 50145-222_62bb10cd-4e99-4e93-a7f5-9dabf692a2d6 50145-222 HUMAN OTC DRUG Hipoglos Zinc Oxide and Lanolin OINTMENT TOPICAL 20101103 OTC MONOGRAPH NOT FINAL part348 Laboratorios Andromaco S.A. LANOLIN; ZINC OXIDE 15; 15 g/100g; g/100g 50153-110_28d7cf3b-d58a-42af-bfc1-521cd57c53c4 50153-110 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130326 UNAPPROVED MEDICAL GAS Island Equipment Company OXYGEN 99 L/100L 50154-0030_575e8741-8aec-4c17-92b6-e7ba43d0fc46 50154-0030 HUMAN OTC DRUG Mellow Instant Hand Sanitizer With Aloe and Vitamin E Ethyl Alcohol GEL TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333A Lantern Enterprises Ltd. ALCOHOL 62 mL/100mL 50154-0040_08259087-acd2-49ab-a4a6-d9121d545481 50154-0040 HUMAN OTC DRUG Mellow Instant Hand Sanitizer Original Ethyl Alcohol GEL TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Lantern Enterprises Ltd. ALCOHOL 62 mL/100mL 50154-1050_270e8603-618f-495c-a9f4-b124097c4180 50154-1050 HUMAN OTC DRUG Instant Hand Sanitizer Original With Moisturizer and Vitamin E ALCOHOL SPRAY TOPICAL 20100506 OTC MONOGRAPH FINAL part333 Lantern Enterprises Ltd ALCOHOL 62 mL/100mL 50154-1060_2af6053a-5a4e-4869-9a32-1938fa38ae53 50154-1060 HUMAN OTC DRUG Instant Hand Sanitizer With Aloe and Vitamin E ALCOHOL SPRAY TOPICAL 20100506 OTC MONOGRAPH FINAL part333 Lantern Enterprises Ltd ALCOHOL 62 mL/100mL 50154-4000_54628be5-806d-4b32-84de-752942892b5d 50154-4000 HUMAN OTC DRUG Instant Hand Sanitizer With Shea Butter Beads ALCOHOL GEL TOPICAL 20100527 OTC MONOGRAPH FINAL part333 Lantern Enterprises Ltd ALCOHOL 62 mL/100mL 50154-5000_d0abeff8-2675-46e9-b244-155e75d7ba96 50154-5000 HUMAN OTC DRUG Instant Hand Sanitizer Unscented With Moisturizer and Vitamin E ALCOHOL GEL TOPICAL 20100527 OTC MONOGRAPH FINAL part333 Lantern Enterprises Ltd ALCOHOL 62 mL/100mL 50157-100_0812c2b7-a905-3252-e054-00144ff88e88 50157-100 HUMAN OTC DRUG Visibly Clean Hand Sanitizer ALCOHOL SOLUTION TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part333E Brands International ALCOHOL 62 mL/100mL 50157-200_d9f0b9a3-32ba-4bdd-bf90-00d22099dfb7 50157-200 HUMAN OTC DRUG secure chloroxylenol AEROSOL, FOAM TOPICAL 20110424 OTC MONOGRAPH NOT FINAL part333A Brands International CHLOROXYLENOL .5 mL/100mL 50164-0001_20e198b2-994e-4ae5-a07a-1c7414aac6c0 50164-0001 HUMAN OTC DRUG Trauma Free Drops Symphytum officinale, Bellis perennis, Hypericum perforatum, Magnesia phosphorica, Ruta graveolens, Arnica montana, LIQUID ORAL 20120626 UNAPPROVED HOMEOPATHIC Sago Natural Products ARNICA MONTANA; BELLIS PERENNIS; COMFREY ROOT; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RUTA GRAVEOLENS FLOWERING TOP 200; 12; 3; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50164-0002_d7c85a29-bc29-4c77-8836-fc8482d7ae56 50164-0002 HUMAN OTC DRUG Trauma Free Symphytum officinale, Bellis perennis, Hypericum perforatum, Magnesia Phosphorica, Ruta graveolens, Arnica montana, LIQUID ORAL 20120621 UNAPPROVED HOMEOPATHIC Sago Natural Products ARNICA MONTANA; BELLIS PERENNIS; COMFREY ROOT; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RUTA GRAVEOLENS FLOWERING TOP 200; 12; 3; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50167-7100_738fc1b8-bfb4-45d7-882a-3d4f90f3d798 50167-7100 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol GEL TOPICAL 20091202 OTC MONOGRAPH FINAL part333 Germs Travel, LLC ALCOHOL .6 g/1 50169-0001_8024fadf-746c-44c5-baa4-57eadbd5e2c8 50169-0001 HUMAN OTC DRUG Type 4 Noise Regular Causticum, Chininum Sulphuricum, Cinchona Officinalis, Pulsatilla, Thiosinaminum TABLET, ORALLY DISINTEGRATING ORAL 20130402 UNAPPROVED HOMEOPATHIC T Gone Remedies ALLYLTHIOUREA; CAUSTICUM; CINCHONA OFFICINALIS BARK; PULSATILLA VULGARIS; QUININE SULFATE 6; 3; 6; 6; 3 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 50169-0002_0cbdfc87-59a1-477a-b0ce-5f3ad0a20d69 50169-0002 HUMAN OTC DRUG Type 3 Sinus Regular Silicea, Hydrastis Canadensis, Kali Bichromicum, Calcarea Carbonica TABLET, ORALLY DISINTEGRATING ORAL 20130403 UNAPPROVED HOMEOPATHIC T Gone Remedies GOLDENSEAL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; SILICON DIOXIDE 6; 12; 6; 6 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 50169-0003_346a698e-1eee-4020-a06d-50fb93b1ccf2 50169-0003 HUMAN OTC DRUG Type 4 Noise Max Causticum, Chininum Sulphuricum, Cinchona Officinalis, Pulsatilla, Thiosinaminum TABLET, ORALLY DISINTEGRATING ORAL 20130410 UNAPPROVED HOMEOPATHIC T Gone Remedies ALLYLTHIOUREA; CAUSTICUM; CINCHONA OFFICINALIS BARK; PULSATILLA VULGARIS; QUININE SULFATE 200; 200; 200; 200; 200 [hp_X]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg 50169-0004_8f509f40-c521-4561-b688-ae3e280cd999 50169-0004 HUMAN OTC DRUG Type 7 Stress Anxiety Regular Kali Phosphoricum, Phosphoricum Acidum, Sepia, Sulphur, Calcarea Carbonica, Silicea TABLET, ORALLY DISINTEGRATING ORAL 20130424 UNAPPROVED HOMEOPATHIC T-Gone Remedies OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR 12; 6; 3; 6; 12; 6 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 50169-0005_2e602966-60ec-4c61-974a-a024e535f902 50169-0005 HUMAN OTC DRUG Type 3 Sinus Max Calcarea Carbonica, Hydrastis Candensis, Kali Bichromicum, Silicea TABLET, ORALLY DISINTEGRATING ORAL 20130905 UNAPPROVED DRUG OTHER TGone Remedies Ltd GOLDENSEAL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; SILICON DIOXIDE 200; 200; 200; 200 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 50169-0006_a0066455-bb88-4b09-8380-0a6f92a6ee58 50169-0006 HUMAN OTC DRUG Type 11 Dizziness Max Belladonna, Calcarea carbonica, Phosphorus, Pulsatilla (Vulgaris), Silicea, TABLET ORAL 20140617 UNAPPROVED HOMEOPATHIC T-Gone Remedies ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE 200; 200; 200; 200; 200 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 50169-0007_912b886b-2c65-40e6-94c0-1b1eb3b5d9fa 50169-0007 HUMAN OTC DRUG Type 7 Stress Anxiety Max Calcarea Carbonica, Kali Phosphoricum, Phosphoricum Acidum, Sepia, Silicea, Sulphur TABLET ORAL 20140708 UNAPPROVED HOMEOPATHIC TGone Remedies Ltd OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR 200; 200; 200; 200; 200; 200 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg 50181-0001_2ff0d2c5-7841-4d38-888b-26dbaa0c06f1 50181-0001 HUMAN OTC DRUG MBM 11 Thyroid Adrenal Iodium, Phytolacca Decandra, Adrenalinu, Adrenocorticotrophin, Thyroidinum, Belladonna, Phosphorus LIQUID ORAL 20120803 UNAPPROVED HOMEOPATHIC The Wellness Center ATROPA BELLADONNA; CORTICOTROPIN; DATURA STRAMONIUM; EPINEPHRINE; IODINE; NUTMEG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SILVER; SODIUM CHLORIDE; SUS SCROFA THYROID 34; 5; 89; 3; 3; 89; 89; 55; 3; 233; 89; 5 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50181-0002_06376563-65e3-4def-a1be-38ffb9f507a3 50181-0002 HUMAN OTC DRUG Thyro T3 Rescue Spongia Tosta, Iodium, Fucus Vesiculosus, Belladonna, Adenosine Triophosphate, Parathyroid (Bovinum), Selenium Metallicum LIQUID ORAL 20120815 UNAPPROVED HOMEOPATHIC The Wellness Center ADENOSINE TRIPHOSPHATE; ATROPA BELLADONNA; BEEF LIVER; BOS TAURUS PARATHYROID GLAND; FUCUS VESICULOSUS; IODINE; LEVOTHYROXINE; LIOTHYRONINE; PORK KIDNEY; SELENIUM; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, PORCINE 6; 4; 8; 8; 3; 3; 3; 3; 8; 8; 3; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50181-0003_b5b01858-7a92-4fea-8a60-63c467841565 50181-0003 HUMAN OTC DRUG MBM 6 Liver Chelidonium Majus, Hepar Suis, Cholesterinum, Lycopodium Clavatum, Tarentula Hispana, Arsenicum Album, Belladonna LIQUID ORAL 20120915 UNAPPROVED HOMEOPATHIC Wellness Center ARSENIC TRIOXIDE; ATROPA BELLADONNA FRUITING TOP; CHELIDONIUM MAJUS; CHOLESTEROL; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; PORK LIVER 233; 233; 3; 21; 144; 144; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50181-0004_805cfc91-ebf0-48e2-a757-93865cc8e410 50181-0004 HUMAN OTC DRUG Endopure Testos for Men DNA, Hypothalamus (suis), RNA, Cortisol, Glandula suprarenalis suis, Pituitary (suis), Prostate (suis), Testosterone, Chelidonium majus, Sabal serrulata, Thuja occidentalis, LIQUID ORAL 20121011 UNAPPROVED HOMEOPATHIC Wellness Center CHELIDONIUM MAJUS; HERRING SPERM DNA; HYDROCORTISONE; SACCHAROMYCES CEREVISIAE RNA; SAW PALMETTO; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; TESTOSTERONE; THUJA OCCIDENTALIS LEAFY TWIG 12; 6; 6; 6; 12; 6; 6; 6; 6; 6; 30 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50181-0005_cec2fcad-10d6-4ee1-b913-dfb3714e51d7 50181-0005 HUMAN OTC DRUG Endopure Testos For Women DNA, Hypothalamus, RNA, Sabal Serrulata, Cortisol, Glandula Suprarenalis Suis, Pituitary, Testosterone LIQUID ORAL 20121011 UNAPPROVED HOMEOPATHIC The Wellness Center CHELIDONIUM MAJUS; HERRING SPERM DNA; HYDROCORTISONE; SACCHAROMYCES CEREVISIAE RNA; SAW PALMETTO; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; TESTOSTERONE; THUJA OCCIDENTALIS LEAFY TWIG 12; 6; 6; 6; 6; 6; 6; 6; 6; 12 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50181-0007_ab4b31ab-828b-40e8-a51c-1657cbf05fd1 50181-0007 HUMAN OTC DRUG Lymph Detox Plus Apis mellifica, Arnica montana, Berberis vulgaris, Gelsemium sempervirens, Hydrastis canadensis, Phytolacca decandra, Solidago virgaurea, LIQUID ORAL 20121012 UNAPPROVED HOMEOPATHIC The Wellness Center APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; PHYTOLACCA AMERICANA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 6; 3; 3; 12; 3; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50181-0008_f311dc73-3c4d-40d6-b2de-94e91f07bd9a 50181-0008 HUMAN OTC DRUG MBM 2 Gallbladder Fel Tauri, Chionanthus Virginica, Nux Vomica, Arsenicum Album, Plantinum Metallicum LIQUID ORAL 20121024 UNAPPROVED HOMEOPATHIC The Wellness Center ARSENIC TRIOXIDE; BOS TAURUS BILE; CHIONANTHUS VIRGINICUS BARK; PLATINUM; STRYCHNOS NUX-VOMICA SEED 233; 3; 34; 233; 34 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 50181-0009_be558b38-b02d-4359-923c-33d8c3f5a4be 50181-0009 HUMAN OTC DRUG 11 Thyroid Adrenal Kodium, Phytocalla decandra, Adrenalinum, Adrenocorticotrophin, Belladonna, Thyroidinum (suis), Natrum muriaticum, Argentum nitricum, Calcarea carbonica, Nux moschata, Phosphorus, LIQUID ORAL 20121012 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. CORTICOTROPIN; EPINEPHRINE; IODINE; NUTMEG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SILVER NITRATE; SODIUM CHLORIDE; SUS SCROFA THYROID 6; 6; 3; 1; 1; 1; 3; 1; 200; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 50181-0010_2ca35b91-9c9d-49ef-8257-9e989e6bb2cf 50181-0010 HUMAN OTC DRUG MBM 3 Heart-Shock Phytolacca Decandra, Spongia Tosta, Crocus Sativus, Coffea Cruda, Aurum Metallicum LIQUID ORAL 20121024 UNAPPROVED HOMEOPATHIC The Wellness Center ARABICA COFFEE BEAN; GOLD; PHYTOLACCA AMERICANA ROOT; SAFFRON; SPONGIA OFFICINALIS SKELETON, ROASTED 34; 34; 3; 34; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50181-0011_7ec5725b-3019-480f-8cca-5a746f7c2213 50181-0011 HUMAN OTC DRUG MBM 10 Stomach Condurango, Stomach (Suis), Nux Vomica, Aurum Metallicum, Antimonium Crudum, Hyoscyamus Niger, Sulphur LIQUID ORAL 20130913 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. ANTIMONY TRISULFIDE; GOLD; HYOSCYAMUS NIGER; MARSDENIA CONDURANGO BARK; STRYCHNOS NUX-VOMICA SEED; SULFUR; SUS SCROFA STOMACH 233; 144; 233; 3; 89; 233; 5 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50181-0012_1299735b-1f5f-47df-b92a-3d336ba00244 50181-0012 HUMAN OTC DRUG 4 Kidney Solidago Virgaurea, Berberis Vulgaris, Aconitum Napellus, Argentum Nitricum, Arnica Montana, Nitricum Acidum LIQUID ORAL 20121012 UNAPPROVED HOMEOPATHIC The Wellness Center ACONITUM NAPELLUS; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; NITRIC ACID; SILVER NITRATE; SOLIDAGO VIRGAUREA FLOWERING TOP 1; 1; 30; 1; 1; 3 [hp_M]/mL; [hp_M]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL 50181-0013_607920a5-8f88-4d46-a302-8ccd540dbe70 50181-0013 HUMAN OTC DRUG 2 Gallbladder Fel Tauri, Chionanthus Virginica, Arsenicum Album, Nux Vomica, Plantinum Metallicum LIQUID ORAL 20121024 UNAPPROVED HOMEOPATHIC The Wellness Center ARSENIC TRIOXIDE; BOS TAURUS BILE; CHIONANTHUS VIRGINICUS BARK; PLATINUM; STRYCHNOS NUX-VOMICA SEED 1; 3; 34; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL 50181-0014_c8cb0d0d-e9cc-4693-810d-5e24caf782cc 50181-0014 HUMAN OTC DRUG Biotox Para Cochlearia Armoracia, Toxoplasma Gondii, Vibrio Cholerae, Candida Albicans, Trichinella Spiralis LIQUID ORAL 20130607 UNAPPROVED HOMEOPATHIC The Wellness Center CANDIDA ALBICANS; HORSERADISH; PLASMODIUM MALARIAE; TARAXACUM OFFICINALE; TOXOPLASMA GONDII; TRICHINELLA SPIRALIS; TRICHOPHYTON RUBRUM; VIBRIO CHOLERAE 30; 3; 12; 8; 12; 30; 200; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50181-0015_6194b870-2f64-4072-af48-7d2f3aae673e 50181-0015 HUMAN PRESCRIPTION DRUG 5 Large Intestine Hydrastis Canadensis, Senna, Agaricus Muscarius, Arnica Montana, Baptisia Tinctoria, Cuprum Metallicum LIQUID ORAL 20121026 UNAPPROVED HOMEOPATHIC The Wellness Center AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARNICA MONTANA; BAPTISIA TINCTORIA; COPPER; GOLDENSEAL; NITRIC ACID; SENNA LEAF 1; 1; 1; 1; 3; 1; 3 [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 50181-0016_ba6d5b5d-a93a-4465-a44f-68d04fa8475e 50181-0016 HUMAN OTC DRUG MBM 5 Large Intestine Hydrastis Canadensis, Large Intestine, Senna, Cuprum Metallicum, Nitricum Acidum, Agaricus Muscarius, Arnica Montanna LIQUID ORAL 20121126 UNAPPROVED HOMEOPATHIC The Wellness Center AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; COPPER; GOLDENSEAL; NITRIC ACID; SENNA LEAF; SUS SCROFA LARGE INTESTINE 144; 144; 144; 89; 3; 89; 3; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50181-0017_48e59b69-cb61-443d-b1a2-fd0709d0d26d 50181-0017 HUMAN OTC DRUG Slim Lycopodium Clavatum, Phytolacca Decandra, Abies Canadensis, Ammonium Bromatum, Ammonium Muriaticum, Pulsatilla LIQUID ORAL 20121130 UNAPPROVED HOMEOPATHIC The Wellness Center AMMONIUM BROMIDE; AMMONIUM CARBONATE; AMMONIUM CHLORIDE; ANTIMONY TRISULFIDE; BOS TAURUS ADRENAL GLAND; CALCIUM ARSENATE; CAPSICUM; FUCUS VESICULOSUS; GRAPHITE; IODINE; IRON; LEPTIN HUMAN; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SILVER NITRATE; SUS SCROFA THYROID; TSUGA CANADENSIS BARK 3; 6; 3; 12; 8; 12; 6; 6; 12; 4; 12; 9; 2; 12; 3; 30; 3; 3; 4; 8; 6; 5; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50181-0018_4e33c23a-3a25-47b2-9d6d-ea8e63749516 50181-0018 HUMAN OTC DRUG MBM 13 Female Oxytocin, Phytolacca Decandra, Pituitary, Scrophularia Nodosa, Hypothalamus, Calcarea Carbonica LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC The Wellness Center BLACK COHOSH; CAUSTICUM; GRAPHITE; LILIUM LANCIFOLIUM WHOLE FLOWERING; OXYTOCIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM PHOSPHATE, DIBASIC; SCROPHULARIA NODOSA; SULFUR; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND 89; 144; 144; 89; 6; 89; 3; 233; 3; 89; 5; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50181-0019_f8147fdf-b118-4a9b-8a69-0838300d0a98 50181-0019 HUMAN OTC DRUG MBM 12 Male Oxytocin, Chimaphila Umbellata, Pituitary, Uva Ursi, Orchitinum, Prostate, Sarsaparilla LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC The Wellness Center ARCTOSTAPHYLOS UVA-URSI LEAF; CHIMAPHILA UMBELLATA; GELSEMIUM SEMPERVIRENS ROOT; OXYTOCIN; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SARSAPARILLA; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; SUS SCROFA TESTICLE; ZINC 5; 3; 34; 6; 233; 144; 8; 3; 8; 5; 55 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50181-0020_7208f1c1-1c14-4236-b6d8-5c90feabaebb 50181-0020 HUMAN OTC DRUG 3 Heart Phytolacca Decandra, Spongia Tosta, Aurum Metallicum, Coffea Cruda, Crocus Sativus LIQUID ORAL 20121228 UNAPPROVED HOMEOPATHIC The Wellness Center ARABICA COFFEE BEAN; GOLD; PHYTOLACCA AMERICANA ROOT; SAFFRON; SPONGIA OFFICINALIS SKELETON, ROASTED 1; 30; 3; 1; 3 [hp_M]/mL; [hp_C]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL 50181-0021_e7ea6725-b393-4d0e-b142-f3aaa52461f6 50181-0021 HUMAN OTC DRUG MBM 4 Kidney Kidney (suis), Solidago virgaurea, Berberis vulgaris, Carcinosinum, Belladonna, Cicuta virosa, Nitricum acidum, Aconitum napellus, Argentum nitricum, Arnica montana, LIQUID ORAL 20130102 UNAPPROVED HOMEOPATHIC The Wellness Center ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA WHOLE; BERBERIS VULGARIS ROOT BARK; CICUTA VIROSA ROOT; HUMAN BREAST TUMOR CELL; NITRIC ACID; PORK KIDNEY; SILVER NITRATE; SOLIDAGO VIRGAUREA FLOWERING TOP 144; 233; 8; 5; 84; 8; 89; 3; 233; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50181-0022_1559c3b7-7cb0-4e9b-9485-a5b1f2c8deca 50181-0022 HUMAN OTC DRUG EndoPure Pro L Arginine, Pineal, Pituitary, Progesteronium, Belladonna, Chelidonium Majus, Dioscorea Villosa, Folliculinum LIQUID ORAL 20130108 UNAPPROVED HOMEOPATHIC The Wellness Center ARGININE; ATROPA BELLADONNA WHOLE; CHELIDONIUM MAJUS; DIOSCOREA VILLOSA TUBER; ESTRONE; LILIUM LANCIFOLIUM WHOLE FLOWERING; PROGESTERONE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND 6; 6; 6; 6; 6; 12; 6; 12; 12; 12; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 50181-0023_5498dfe1-daff-4f4b-86e8-cfa3baed9b87 50181-0023 HUMAN OTC DRUG EndoPure Estro Estriol, Estradiol, Folliculinum, Belladonna, Chelidonium Majus, Cortisol, Glandula Suprarenalis Suis LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC The Wellness Center ATROPA BELLADONNA WHOLE; CHELIDONIUM MAJUS; ESTRADIOL; ESTRIOL; ESTRONE; HYDROCORTISONE; LILIUM LANCIFOLIUM WHOLE FLOWERING; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND 6; 6; 6; 6; 6; 6; 12; 12; 6; 12; 12; 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50181-0024_fbe787d0-a6c3-4634-9f51-2bb25deb617e 50181-0024 HUMAN OTC DRUG MBM 8 Small Intestine Condurango, Intestine, Phytolacca Decandra, Aconitum Napellus, Aurum Metallicum, Sulphur LIQUID ORAL 20130405 UNAPPROVED HOMEOPATHIC The Wellness Center ACONITUM NAPELLUS; GOLD; GOLDENSEAL; GRAPHITE; MARSDENIA CONDURANGO BARK; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; PORK INTESTINE; PULSATILLA VULGARIS; SULFUR 55; 55; 89; 233; 3; 144; 3; 3; 233; 55 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50181-0025_87dda463-afe6-4675-9347-af54ca5d4354 50181-0025 HUMAN OTC DRUG NEUROBALANCE PRO Adrenocorticotrophin, Gaba, Glutamic Acid, norepinephrine, Acetylcholine Chloride, Adrenalinum, L-Dopa, Serotonin, Thyroidinum (Suis) LIQUID ORAL 20130809 UNAPPROVED HOMEOPATHIC The Wellness Center for Reseach and Education, Inc. .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; BARIUM CARBONATE; CORTICOTROPIN; DATURA STRAMONIUM; EPINEPHRINE; GLUTAMIC ACID; LEVODOPA; NOREPINEPHRINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEMECARPUS ANACARDIUM JUICE; SEROTONIN; SUS SCROFA THYROID 6; 6; 6; 6; 30; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 50181-0026_be19494e-cc53-4b2f-bf17-ef153bd2ae78 50181-0026 HUMAN OTC DRUG 6 Liver Chelidonium Majus, Cholesterinum, Arsenicum Album, Belladonna, Lycopodium Clavatum, Tarentula Hispana LIQUID ORAL 20130809 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; CHELIDONIUM MAJUS; CHOLESTEROL; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA 1; 1; 3; 30; 1; 10 [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL 50181-0029_97a0956a-af2c-416f-95aa-752afa584118 50181-0029 HUMAN OTC DRUG 8 Small Intestine Condurango, Phytolacca Decandra, Aconitum Napellus, Aurum Metallicum, Graphites, Hydrastis Canadensis, Mercurius Vivus, Sulphur, Pulsatilla LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC The Wellness Center ACONITUM NAPELLUS; GOLD; GOLDENSEAL; GRAPHITE; MARSDENIA CONDURANGO BARK; MERCURY; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SULFUR 1; 1; 1; 1; 3; 1; 3; 10; 1 [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_M]/mL 50181-0030_7804a88d-aa5d-4103-bc66-541a75fa8522 50181-0030 HUMAN OTC DRUG 12 Male Reproductive Chimaphila Umbellata, Pituitaria Glandula (Suis), Sabal Serrulata, Uva-Ursi, Gelsemium Sempervirens, Sarsaparilla (Smilax Regelii) LIQUID ORAL 20130904 UNAPPROVED HOMEOPATHIC The Wellness Center ARCTOSTAPHYLOS UVA-URSI LEAF; CHIMAPHILA UMBELLATA; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SARSAPARILLA; SAW PALMETTO; SUS SCROFA PITUITARY GLAND; ZINC 6; 3; 30; 1; 1; 30; 6; 3; 1 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_M]/mL 50181-0031_c3de0ab3-1e88-4a95-8ac7-0935c73d90f4 50181-0031 HUMAN OTC DRUG Mercury Plus Detox Glutathione, Reduced, Brain (Suis), Spinal Cord (Suis), Thuja Occidentalis, Dimercaptopropane Sulfonate, Mercurius Solubilis, Silver Amalgam LIQUID ORAL 20130905 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. COPPER; GLUTATHIONE; MERCURIUS SOLUBILIS; MERCURY; PORK BRAIN; SILVER; SUS SCROFA SPINAL CORD; THIMEROSAL; THUJA OCCIDENTALIS LEAF; TIN; UNITHIOL 12; 6; 8; 30; 6; 12; 6; 30; 6; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50181-0032_fe7e5870-e01d-4237-849e-228f04a3cbc0 50181-0032 HUMAN OTC DRUG MBM 9 SPLEEN/PANCREAS Ceanothus americanus, Senna, Pancreas Suis, Spleen, Chionanthus virginica, Cinchona officinalis, Sepia, Arsenicum album, Lycopodium clavatum LIQUID ORAL 20131031 UNAPPROVED HOMEOPATHIC The Wellness Center ARSENIC TRIOXIDE; CEANOTHUS AMERICANUS LEAF; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; SENNA LEAF; SEPIA OFFICINALIS JUICE; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN 233; 3; 34; 89; 233; 3; 144; 5; 5 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50181-0038_1d2710ab-c8cd-4b67-8c97-73d6d48eaa6b 50181-0038 HUMAN OTC DRUG BioTox Lyme Phytolacca decandra, Ehrlichia, Mycoplasma pneumoniae, Borrelia burgdorferi, Babesia microti, Coxiella burnetii, Chelidonium majus, Herpes zoster, LIQUID ORAL 20140313 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education BABESIA MICROTI; BORRELIA BURGDORFERI; CHELIDONIUM MAJUS; COXIELLA BURNETII; EHRLICHIA CHAFFEENSIS; FRANCISELLA TULARENSIS; HUMAN HERPESVIRUS 3; MYCOPLASMA PNEUMONIAE; PHYTOLACCA AMERICANA ROOT; RICKETTSIA RICKETTSII 15; 12; 6; 30; 8; 6; 6; 9; 6; 7 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 50181-0044_850b5ab0-db54-43d2-892e-1bd27810a8ba 50181-0044 HUMAN OTC DRUG ALL FLU Aconitum napellus, Arsenicum iodatum, Bryonia (Alba), Eupatorium perfoliatum, Gelsenium sempervirens, Helix tosta, PELLET ORAL 20140619 UNAPPROVED HOMEOPATHIC The Wellness Center For Research and Education ACONITUM NAPELLUS; ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ESCARGOT SHELL, COOKED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HYDROGEN; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); PHOSPHORUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM VIRIDE ROOT; WOOD CREOSOTE 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g 50181-0045_6b49a27d-95f7-4968-9bc0-1e3cb842b6bb 50181-0045 HUMAN OTC DRUG BioTox Bac I Cochlearia armoracia, Taraxacum officinale, Tabebuia impetiginosa, Brucella abortus, Colibacillinum cum natrum muriaticum, Germanium, Pertussinum, Anthracinum, LIQUID ORAL 20140408 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BACILLUS CEREUS; BRUCELLA ABORTUS; BRUCELLA MELITENSIS; CITROBACTER KOSERI; CLOSTRIDIUM TETANI; COXIELLA BURNETII; ENTEROBACTER AEROGENES; ESCHERICHIA COLI; FRANCISELLA TULARENSIS; GERMANIUM; HORSERADISH; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; PROTEUS MIRABILIS; PSEUDOMONAS AERUGINOSA; RANCID BEEF; SERRATIA MARCESCENS; TABEBUIA IMPETIGINOSA BARK; TARAXACUM OFFICINALE; YERSINIA ENTEROCOLITICA; YERSINIA PESTIS 60; 12; 12; 9; 9; 60; 60; 15; 12; 60; 15; 3; 30; 30; 60; 60; 12; 3; 3; 60; 15 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [iU]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 50181-0046_157fbb2e-3bcc-4d91-a264-edd3dc6460ba 50181-0046 HUMAN OTC DRUG BIOTOX BAC 2 Streptococcus viridans, Chlamydia trachomatis, Bacillus tetani, Meningococcus nosode, Phytolacca decandra, Streptococcus agalactiae, Streptococcus pheumoniae, LIQUID ORAL 20140512 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. CHLAMYDIA TRACHOMATIS; CLOSTRIDIUM PERFRINGENS; CLOSTRIDIUM TETANI; ENTEROCOCCUS FAECALIS; LISTERIA MONOCYTOGENES; NEISSERIA MENINGITIDIS; PHYTOLACCA AMERICANA ROOT; SHIGELLA DYSENTERIAE; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS EQUINUS; STREPTOCOCCUS MUTANS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS UBERIS; STREPTOCOCCUS VIRIDANS GROUP 9; 15; 12; 9; 12; 15; 6; 12; 6; 12; 30; 9; 6; 12; 8 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 50181-0050_945cf7e3-343f-4a98-97c9-b5aa40444c43 50181-0050 HUMAN OTC DRUG 9 Spleen Pancreas CEANOTHUS AMERICANUS, SENNA (CASSIA ANGUSTIFOLIA), CHIONANTHUS VIRGINICA, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, SEPIA LIQUID ORAL 20141215 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. ARSENIC TRIOXIDE; CEANOTHUS AMERICANUS LEAF; CHIONANTHUS VIRGINICUS BARK; LYCOPODIUM CLAVATUM SPORE; SENNA LEAF; SEPIA OFFICINALIS JUICE 1; 3; 30; 1; 3; 1 [hp_M]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL 50181-0051_1b3653af-81be-4e5b-9ea2-a5fe37170859 50181-0051 HUMAN OTC DRUG 10 STOMACH CONDURANGO, ANTIMONIUM CRUDUM, AURUM METALLICUM, HYOSCYAMUS NIGER, NUX VOMICA, SULPHUR LIQUID ORAL 20141208 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. ANTIMONY TRISULFIDE; GOLD; HYOSCYAMUS NIGER; MARSDENIA CONDURANGO BARK; STRYCHNOS NUX-VOMICA SEED; SULFUR 1; 1; 1; 3; 1; 1 [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_M]/mL 50181-0052_ddf8fdc4-1e1f-401c-89a3-6f2f0a14dcef 50181-0052 HUMAN OTC DRUG 7 LUNG COCCUS CACTI, IGNATIA AMARA, CAUSTICUM, NATRUM MURIATICUM LIQUID ORAL 20141205 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. CAUSTICUM; PROTORTONIA CACTI; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 1; 3; 5; 600 [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL 50183-112_c42571fb-3f0e-4328-92c7-759ff5140b55 50183-112 HUMAN OTC DRUG go wipes benzalkonium chloride CLOTH TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 American Hygiene Industries BENZALKONIUM CHLORIDE 3.48 g/34.8g 50184-1000_438aff74-9816-41f3-967b-0c02dc008179 50184-1000 HUMAN OTC DRUG help me broad spectrum spf 30 sunscreen retinol day treatment lotion Avobenzone LIQUID TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 Philosophy Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .6; 3; 1.5; .45; 1.2 mL/30mL; mL/30mL; mL/30mL; mL/30mL; mL/30mL 50184-1005_148012ef-5c25-4c53-b11e-24085a5bb0d9 50184-1005 HUMAN OTC DRUG clear days ahead oil-free salicylic acid acne treatment cleanser Salicylic Acid LIQUID TOPICAL 20120401 OTC MONOGRAPH FINAL part333D Philosophy Inc. SALICYLIC ACID 2.4 mL/240mL 50184-1010_0c7d5336-1b7a-4520-943b-b4e09fc03432 50184-1010 HUMAN OTC DRUG clear days ahead oil-free salicylic acid acne treatment and moisturizer Salicylic Acid CREAM TOPICAL 20120401 OTC MONOGRAPH FINAL part333D Philosophy Inc. SALICYLIC ACID .6 mL/60mL 50184-1015_1dff6f6e-e4f4-43c6-8b37-498e692bc859 50184-1015 HUMAN OTC DRUG clear days ahead overnight repair salicylic acid acne treatment pads Salicylic Acid CLOTH TOPICAL 20120401 OTC MONOGRAPH FINAL part333D Philosophy Inc. SALICYLIC ACID 283.5 mg/56.7g 50184-1020_b5fe3060-a2ce-430b-b1e3-26edc1a06674 50184-1020 HUMAN OTC DRUG clear days ahead fast-acting salicylic acid acne spot treatment Salicylic Acid GEL TOPICAL 20120401 OTC MONOGRAPH FINAL part333D Philosophy SALICYLIC ACID .3 mL/15mL 50184-1025_38c3d5fb-ae5d-4bfd-9649-1485e4c42d9d 50184-1025 HUMAN OTC DRUG clear days ahead 30-day acne trial kit salicylic acid KIT TOPICAL 20120401 OTC MONOGRAPH FINAL part333D Philosophy, Inc. 50184-1026_9705f8c0-9b78-4918-b06e-ddc730d93caf 50184-1026 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen natural ivory Zinc Oxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE 882.7 mg/9.1g 50184-1027_19498a1d-4692-4f5a-be99-24cdae00d51c 50184-1027 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen beige Zinc Oxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE 882.7 mg/9.1g 50184-1028_ed1a3739-b64f-46d8-80c7-878630c30525 50184-1028 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen bronze Zinc Oxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE 882.7 mg/9.1g 50184-1029_3ef2d5dc-1b60-46d2-a7f2-7ef344476966 50184-1029 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen rich Zinc Oxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE 882.7 mg/9.1g 50184-1030_acc9bec2-b872-4d2c-9505-6e7f4194b423 50184-1030 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen extra rich Zinc Oxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE 882.7 mg/9.1g 50184-1031_bf4e2bad-073f-4078-b93c-c7579cc31f8a 50184-1031 HUMAN OTC DRUG Keep the Peace Broad Spectrum SPF 20 Sunscreen Protective Color Corrector Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; ZINC OXIDE 11.52; 2.772 g/60mL; g/60mL 50184-1032_2082c139-d898-4829-a64e-0cf83086477e 50184-1032 HUMAN OTC DRUG hope in a jar broad spectrum spf 25 sunscreen and moisturizer for all skin types Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 Philosophy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.088; 2.838; 3.041; 1.733; 3.96 g/60mL; g/60mL; g/60mL; g/60mL; g/60mL 50184-1033_882bbc29-ee32-4f06-92f5-92836045d18b 50184-1033 HUMAN OTC DRUG hope in a jar a to z cream broad spectrum spf 20 sunscreen Titanium Dioxide, zinc oxide CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part352 Philosophy TITANIUM DIOXIDE; ZINC OXIDE 3.35; 5.49 g/30mL; g/30mL 50184-1034_80501217-b3b3-421e-8b1a-2024a74e23f5 50184-1034 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen natural ivory Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy TITANIUM DIOXIDE; ZINC OXIDE 5.733; 882.7 g/9.1g; mg/9.1g 50184-1035_f0dde3fb-593f-4d13-8ec9-55b3b1621a5b 50184-1035 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen medium beige Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy TITANIUM DIOXIDE; ZINC OXIDE 5.49; .455 mg/9.1g; mg/9.1g 50184-1036_f23dc8f8-22f6-4fbc-8489-1b6e77d323bd 50184-1036 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen beige Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy TITANIUM DIOXIDE; ZINC OXIDE 5.49; 882.7 mg/9.1g; mg/9.1g 50184-1037_56191ccf-b83c-459f-a1f0-9cd9f8c2a273 50184-1037 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen fair Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy TITANIUM DIOXIDE; ZINC OXIDE 5.49; 882.7 mg/9.1g; mg/9.1g 50184-1038_a9962ddc-c3b8-47ce-9569-3948377bc2a4 50184-1038 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen honey Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy TITANIUM DIOXIDE; ZINC OXIDE 5.49; 882.7 mg/9.1g; mg/9.1g 50184-1039_e41d7335-3ea9-439d-96c5-988b7f6bd4f4 50184-1039 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen light bronze Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy TITANIUM DIOXIDE; ZINC OXIDE 5.49; 882.7 mg/9.1g; mg/9.1g 50184-1040_245c2233-9cd6-4f69-88d5-267997047952 50184-1040 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen rich toffee Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy TITANIUM DIOXIDE; ZINC OXIDE 5.49; 882.7 mg/9.1g; mg/9.1g 50184-1041_9e14ab5c-b8f7-46d4-a207-c0ec58503ebc 50184-1041 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen sand Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy TITANIUM DIOXIDE; ZINC OXIDE 5.49; 882.7 mg/9.1g; mg/9.1g 50184-2900_71718b49-ed10-4144-a696-74646ef93f7e 50184-2900 HUMAN OTC DRUG Hope In A Bottle SALICYLIC ACID LOTION TOPICAL 20110928 OTC MONOGRAPH FINAL part333D Philosophy, Inc. SALICYLIC ACID 1.184 mL/59.2mL 50184-3800_420e85e6-34b5-4635-b154-bc9b73fc7d9f 50184-3800 HUMAN OTC DRUG Supernatural Poreless Flawless Tinted SPF 15 Octisalate and Titanium Dioxide CREAM TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. OCTISALATE; TITANIUM DIOXIDE 50; 40 mg/g; mg/g 50184-4700_50e7bd88-779b-424f-aa74-938a90603f7e 50184-4700 HUMAN OTC DRUG Shelter Tinted octinoxate, octisalate, oxybenzone, titanium dioxide CREAM TOPICAL 20040914 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 50; 50; 10 mg/g; mg/g; mg/g; mg/g 50184-4800_d57415b0-ed15-4226-9d41-184f96e1ca91 50184-4800 HUMAN OTC DRUG Shelter Octinoxate and Octisalate and Oxybenzone and Titanium Dioxide CREAM TOPICAL 20040914 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 50; 50; 12 mg/g; mg/g; mg/g; mg/g 50184-6000_29725a47-cab0-4a10-b849-d1da1580890b 50184-6000 HUMAN OTC DRUG Supernatural Superbeautiful Makeup SPF 15 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; ZINC OXIDE 45; 20 mg/g; mg/g 50184-6100_9cca60d6-7b77-4601-bfc1-d9800406e5a3 50184-6100 HUMAN OTC DRUG Hope Oil Free Moisturizer SPF 30 Octinoxate and Octisalate and Oxybenzone and zinc oxide CREAM TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 75; 50; 40; 45 mg/g; mg/g; mg/g; mg/g 50184-6200_4ffd2344-84c8-487c-8863-55ed5aff6d8b 50184-6200 HUMAN OTC DRUG Hope In A Jar SPF 25 avobenzone and homosalate and octisalate and octocrylene and oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 45; 50; 27.5; 50 mg/g; mg/g; mg/g; mg/g; mg/g 50184-6300_6f514ddf-08f3-40f1-af01-5b92a430fef7 50184-6300 HUMAN OTC DRUG Hope In A Tinted Moisturizer octinoxate, oxybenzone CREAM TOPICAL 20100825 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. OCTINOXATE; OXYBENZONE 3.75; 1.75 mL/50mL; mL/50mL 50184-6400_5de3d011-a893-498f-b8ad-1c528e3c897b 50184-6400 HUMAN OTC DRUG Hope In A Jar For Dry Skin SPF broad spectrum spf 20 sunscreen and extra-rich moisturizer for normal to dry skin avobenzone, octinoxate, and oxybenzone CREAM TOPICAL 20101022 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE 1.392; 4.242; 1.98 g/60mL; g/60mL; g/60mL 50184-6500_46163b03-b532-4d5d-99f1-c9d024800086 50184-6500 HUMAN OTC DRUG Miracle Worker SPF 55 avobenzone, homosalate, octisalate, octocrylene and oxybenzone CREAM TOPICAL 20101119 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 5; 2.5; 1; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL 50184-6600_ad44f5ba-c6f9-4f87-a3fc-1edc4ceb753c 50184-6600 HUMAN OTC DRUG Keep The Peace Protect and Correct Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20110124 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; ZINC OXIDE 2.88; 1.8 mL/60mL; mL/60mL 50184-6700_e8ea185f-414e-4dbb-9823-4308d1085598 50184-6700 HUMAN OTC DRUG Divine Lift Foundation SPF Octinoxate and Titanium Dioxide CREAM TOPICAL 20110105 OTC MONOGRAPH NOT FINAL part352 Philosophy Inc. OCTINOXATE; TITANIUM DIOXIDE 1.065; .71 g/14.2g; g/14.2g 50184-6800_f408d8b4-9fa8-485a-8daf-d24a0e863ed2 50184-6800 HUMAN OTC DRUG Kiss of Hope SPF 15 Octinoxate and Oxybenzone STICK TOPICAL 20110207 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. OCTINOXATE; OXYBENZONE .238; .102 g/3.4g; g/3.4g 50184-6900_936d0093-f7c6-4730-b0ff-15a22a87301b 50184-6900 HUMAN OTC DRUG Kiss of Hope Pink Tinted SPF 15 Octinoxate and Oxybenzone STICK TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. OCTINOXATE; OXYBENZONE .238; .102 g/3.4g; g/3.4g 50184-7000_51cb3fb5-c7ed-4d0c-9d9c-6f245732b918 50184-7000 HUMAN OTC DRUG Divine Illumination Divine Flawless Foundation SPF 50 TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20120114 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; ZINC OXIDE 4.68; 4.5 mL/45mL; mL/45mL 50191-0001_0d0db30e-b120-4870-96ba-3c2696b1e999 50191-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091203 UNAPPROVED MEDICAL GAS Home Health Depot OXYGEN 99 L/100L 50192-113_3a38ddb1-2e6b-406e-8992-a1c9cbd9acd0 50192-113 HUMAN PRESCRIPTION DRUG CAMBIA Diclofenac Potassium POWDER, FOR SOLUTION ORAL 20100420 NDA NDA022165 Nautilus Neurosciences, Inc. DICLOFENAC POTASSIUM 1 mg/mg Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50198-2826_c26150bf-c0d5-465e-a559-ea4e61e08318 50198-2826 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090101 UNAPPROVED MEDICAL GAS WeCare Medical LLC OXYGEN 1000 mL/L 50201-0246_b3d1e541-da02-4735-81be-b4a45f045c7b 50201-0246 HUMAN OTC DRUG Effervescent Cold Relief ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE TABLET, EFFERVESCENT ORAL 20100701 OTC MONOGRAPH FINAL part341 Tower Laboratories Ltd ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 50201-0421_8e9ea3a9-85a4-474f-bc0f-201839c3ff61 50201-0421 HUMAN OTC DRUG BROMO SELTZER ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET, EFFERVESCENT ORAL 20121001 OTC MONOGRAPH FINAL part343 Tower Laboratories Ltd ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE 1000; 325; 1916 mg/1; mg/1; mg/1 50201-2400_3e793569-811c-4f71-8c0f-06eb94edad5a 50201-2400 HUMAN PRESCRIPTION DRUG TowerX Effervescent Potassium POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20060106 UNAPPROVED DRUG OTHER Tower Laboratories Ltd POTASSIUM BICARBONATE 25 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 50211-001_559c93c2-a949-4fd9-98cb-7bb570c6de0e 50211-001 HUMAN OTC DRUG Hemo Fin Petrolatum OINTMENT RECTAL 20120910 OTC MONOGRAPH FINAL part346 PD MERC LLC PETROLATUM 93.3 g/100g 50220-001_b1baeda9-c804-4012-8932-6f5f3a7ca4e3 50220-001 HUMAN PRESCRIPTION DRUG Esterified Estrogens and Methyltestosterone Esterified Estrogens and Methyltestosterone TABLET, FILM COATED ORAL 20100917 UNAPPROVED DRUG OTHER Tal Pharma LLC ESTRONE SODIUM SULFATE; METHYLTESTOSTERONE .625; 1.25 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 50220-002_b1baeda9-c804-4012-8932-6f5f3a7ca4e3 50220-002 HUMAN PRESCRIPTION DRUG Esterified Estrogens and Methyltestosterone Esterified Estrogens and Methyltestosterone TABLET, FILM COATED ORAL 20100917 UNAPPROVED DRUG OTHER Tal Pharma LLC ESTRONE SODIUM SULFATE; METHYLTESTOSTERONE 1.25; 2.5 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 50222-227_ed10f3e1-0e78-4107-a9d0-1c87ff676925 50222-227 HUMAN PRESCRIPTION DRUG Taclonex calcipotriene and betamethasone dipropionate OINTMENT TOPICAL 20080601 NDA NDA021852 LEO Pharma Inc. BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE .5; 50 mg/g; ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50222-260_62f784a1-888a-4458-8fe0-eb007248a578 50222-260 HUMAN PRESCRIPTION DRUG Dovonex Calcipotriene CREAM TOPICAL 19961001 NDA NDA020554 LEO Pharma Inc. CALCIPOTRIENE 50 ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 50222-342_7974c460-d162-11df-9349-0002a5d5c51b 50222-342 HUMAN PRESCRIPTION DRUG INNOHEP tinzaparin sodium INJECTION, SOLUTION SUBCUTANEOUS 20100701 NDA NDA020484 LEO Pharma Inc. TINZAPARIN SODIUM 20000 [iU]/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 50222-403_0cd3003c-fad0-42ec-ab26-4b4d772c7e49 50222-403 HUMAN PRESCRIPTION DRUG Dovonex Calcipotriene SOLUTION TOPICAL 19970601 NDA NDA020611 LEO Pharma Inc. CALCIPOTRIENE .05 mg/mL Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 50222-501_8ebf899f-bb2b-48f1-b6f8-4a7294160eea 50222-501 HUMAN PRESCRIPTION DRUG TACLONEX calcipotriene and betamethasone dipropionate SUSPENSION TOPICAL 20080601 NDA NDA022185 LEO Pharma Inc. BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE .5; 50 mg/g; ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50222-502_3a08a865-1ea6-4d97-9e25-55647c3aea4b 50222-502 HUMAN PRESCRIPTION DRUG Picato ingenol mebutate GEL TOPICAL 20120123 NDA NDA202833 LEO Pharma Inc. INGENOL MEBUTATE 150 ug/g Cell Death Inducer [EPC],Increased Cellular Death [PE] 50222-503_3a08a865-1ea6-4d97-9e25-55647c3aea4b 50222-503 HUMAN PRESCRIPTION DRUG Picato ingenol mebutate GEL TOPICAL 20120123 NDA NDA202833 LEO Pharma Inc. INGENOL MEBUTATE 500 ug/g Cell Death Inducer [EPC],Increased Cellular Death [PE] 50224-002_028f7e8a-ca00-4456-a1d6-b94235741d6c 50224-002 HUMAN PRESCRIPTION DRUG Refissa Tretinoin CREAM TOPICAL 20090617 ANDA ANDA076498 Suneva Medical, Inc. TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 50224-002_09e54922-049f-48fe-953a-3320621413f3 50224-002 HUMAN PRESCRIPTION DRUG REFISSA TRETINOIN CREAM TOPICAL 20090617 ANDA ANDA076498 Suneva Medical, Inc. TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 50225-355_f9ca8878-77e5-4644-965f-e4b75ac6fa34 50225-355 HUMAN OTC DRUG Instant Hand Sanitizer Instant Hand Sanitizer GEL TOPICAL 20100106 OTC MONOGRAPH FINAL part333 Global Protection USA, Inc. ALCOHOL 60 g/mL 50227-0501_b67d45f7-77f8-4a06-aa4d-4db91a9a7d92 50227-0501 HUMAN PRESCRIPTION DRUG Topical 60 Sec Sodium Fluoride Strawberry Sodium Fluoride AEROSOL, FOAM TOPICAL 19970401 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 123 mg/g 50227-0511_719aaea7-cf05-4f74-8e97-8284cdf535bb 50227-0511 HUMAN PRESCRIPTION DRUG Topical 60 Sec Sodium Fluoride Mint Sodium Fluoride AEROSOL, FOAM TOPICAL 19970401 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 123 mg/g 50227-0521_b711eb86-8ef8-48cf-a4ea-6c4c49a877cc 50227-0521 HUMAN PRESCRIPTION DRUG Topical 60 Sec Sodium Fluoride Bubble Gum Sodium Fluoride AEROSOL, FOAM TOPICAL 19970401 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 123 mg/g 50227-0531_15ab2941-7281-49f5-bc25-6293893e1c73 50227-0531 HUMAN PRESCRIPTION DRUG Topical 60 Sec Sodium Fluoride Grape Sodium Fluoride AEROSOL, FOAM TOPICAL 19970401 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 123 mg/g 50227-0541_30034c1e-56bf-4c01-b8ed-45ecfad739df 50227-0541 HUMAN PRESCRIPTION DRUG Topical 60 Sec Sodium Fluoride Orange Cream Sodium Fluoride AEROSOL, FOAM TOPICAL 19970401 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 123 mg/g 50227-1006_e706de58-1350-47c2-83d2-0b8562ac5953 50227-1006 HUMAN PRESCRIPTION DRUG Take Home Fluoride Cool Mint Sodium Fluoride GEL, DENTIFRICE DENTAL 19970415 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 5 mg/g 50227-1020_23186b52-57d2-4866-b811-b5dcc006fd8f 50227-1020 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088389 Patterson Dental EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .02; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 50227-1030_85360e45-5667-4ed8-ba20-63c1b437d164 50227-1030 HUMAN PRESCRIPTION DRUG LIDOCAINE Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088390 Patterson Dental EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 50227-1040_9d18ab68-5316-408b-b2d1-39e844a85f0e 50227-1040 HUMAN PRESCRIPTION DRUG ARTICAINE Articaine Hydrochloride and Epinephrine INJECTION, SOLUTION SUBCUTANEOUS 20141222 NDA NDA020971 Patterson Dental ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 50227-1050_bc5f3728-4993-45a1-a873-3750883a975a 50227-1050 HUMAN PRESCRIPTION DRUG ARTICAINE Articaine Hydrochloride and Epinephrine INJECTION, SOLUTION SUBCUTANEOUS 20141222 NDA NDA020971 Patterson Dental ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 50227-1080_edcf25c4-d755-4db4-b5c8-3a71c077fbc5 50227-1080 HUMAN PRESCRIPTION DRUG Mepivacaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA088387 Patterson Dental Supply, Inc. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 50227-1090_edcf25c4-d755-4db4-b5c8-3a71c077fbc5 50227-1090 HUMAN PRESCRIPTION DRUG Mepivacaine with levonordefrin Mepivacaine Hydrochloride and Levonordefrin INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA088388 Patterson Dental Supply, Inc. LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE .05; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 50227-2110_ab34ed6b-565e-43b1-ac3f-41092504f48b 50227-2110 HUMAN OTC DRUG Topical Anesthetic Pina Colada Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Patterson Dental Supply Inc BENZOCAINE 220 mg/g 50227-2111_22efcf7c-4ffd-4519-ad4a-05cf422a4882 50227-2111 HUMAN OTC DRUG Topical Anesthetic Strawberry Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Patterson Dental Supply Inc BENZOCAINE 220 mg/g 50227-2112_7f2da304-84cf-435c-9246-903a05ef2cdc 50227-2112 HUMAN OTC DRUG Topical Anesthetic Mint Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Patterson Dental Supply Inc BENZOCAINE 220 mg/g 50227-2113_b56a0462-a028-4d4d-8a21-036ac1ac53bc 50227-2113 HUMAN OTC DRUG Topical Anesthetic Raspberry Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Patterson Dental Supply Inc BENZOCAINE 220 mg/g 50227-2114_561311f4-566e-454f-a451-1b84ebfad810 50227-2114 HUMAN OTC DRUG Topical Anesthetic Bubble Gum Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Patterson Dental Supply Inc BENZOCAINE 220 mg/g 50227-2115_33c213ed-f380-4b4b-90cd-8ead44c7d8a5 50227-2115 HUMAN OTC DRUG Topical Anesthetic Cherry Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Patterson Dental Supply Inc BENZOCAINE 220 mg/g 50227-2116_69850139-6b9d-4bcd-b448-8a2fdb0bbfa5 50227-2116 HUMAN PRESCRIPTION DRUG Topical Anesthetic Banana Benzocaine GEL, DENTIFRICE DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Patterson Dental BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 50227-3211_ea05caa6-a1b7-41f7-8c4a-8b0458dfbfc3 50227-3211 HUMAN PRESCRIPTION DRUG 60-Second Fluoride Cherry Sodium Fluoride GEL DENTAL 19780101 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 12.3 mg/g 50227-3221_ea05caa6-a1b7-41f7-8c4a-8b0458dfbfc3 50227-3221 HUMAN PRESCRIPTION DRUG 60-Second Fluoride Mint Sodium Fluoride GEL DENTAL 19780101 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 12.3 mg/g 50227-3241_ea05caa6-a1b7-41f7-8c4a-8b0458dfbfc3 50227-3241 HUMAN PRESCRIPTION DRUG 60-Second Fluoride Pina Colada Sodium Fluoride GEL DENTAL 19780101 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 12.3 mg/g 50227-3251_ea05caa6-a1b7-41f7-8c4a-8b0458dfbfc3 50227-3251 HUMAN PRESCRIPTION DRUG 60-Second Fluoride Bubble Gum Sodium Fluoride GEL DENTAL 19780101 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 12.3 mg/g 50227-3271_ea05caa6-a1b7-41f7-8c4a-8b0458dfbfc3 50227-3271 HUMAN PRESCRIPTION DRUG 60-Second Fluoride Orange Cream Sodium Fluoride GEL DENTAL 19780101 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 12.3 mg/g 50228-105_22727b6d-afd8-4344-9ad0-b5569fd6e766 50228-105 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130911 ANDA ANDA203769 ScieGen Pharmaceuticals Inc METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 50228-106_22727b6d-afd8-4344-9ad0-b5569fd6e766 50228-106 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130911 ANDA ANDA203769 ScieGen Pharmaceuticals Inc METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 50228-107_22727b6d-afd8-4344-9ad0-b5569fd6e766 50228-107 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130911 ANDA ANDA203769 ScieGen Pharmaceuticals Inc METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 50228-109_695a3600-461e-4881-b86c-306037e90f20 50228-109 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20140127 ANDA ANDA203374 ScieGen Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 50228-111_f0e6a5dd-841d-49e8-befc-e28ab067dd20 50228-111 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20140723 ANDA ANDA203018 ScieGen Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 50228-112_f0e6a5dd-841d-49e8-befc-e28ab067dd20 50228-112 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20140205 ANDA ANDA203018 ScieGen Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 50228-121_a2f35417-4b97-4fe5-bf42-987d8ad22449 50228-121 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20140915 ANDA ANDA204165 ScieGen Pharmaceuticals Inc CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 50228-124_a2f35417-4b97-4fe5-bf42-987d8ad22449 50228-124 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20140915 ANDA ANDA204165 ScieGen Pharmaceuticals Inc CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 50228-126_3538415f-de0d-4e3e-b6b9-e07ee1c0ab4c 50228-126 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 ScieGen Pharmaceuticals Inc PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 50228-127_3538415f-de0d-4e3e-b6b9-e07ee1c0ab4c 50228-127 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 ScieGen Pharmaceuticals Inc PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 50228-128_3538415f-de0d-4e3e-b6b9-e07ee1c0ab4c 50228-128 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 ScieGen Pharmaceuticals Inc PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 50228-129_3538415f-de0d-4e3e-b6b9-e07ee1c0ab4c 50228-129 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 ScieGen Pharmaceuticals Inc PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 50228-130_3538415f-de0d-4e3e-b6b9-e07ee1c0ab4c 50228-130 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 ScieGen Pharmaceuticals Inc PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 50228-131_3538415f-de0d-4e3e-b6b9-e07ee1c0ab4c 50228-131 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 ScieGen Pharmaceuticals Inc PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 50228-136_3b90226a-3990-4626-8f7d-ed0ba3566a43 50228-136 HUMAN PRESCRIPTION DRUG levocetirizine dihydrochloride levocetirizine dihydrochloride TABLET ORAL 20140909 ANDA ANDA203646 ScieGen Pharmaceuticals, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 50228-139_90dab690-5fcd-4c9e-98f1-dfebbb71cfd3 50228-139 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20141029 ANDA ANDA203907 ScieGen Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 50228-140_90dab690-5fcd-4c9e-98f1-dfebbb71cfd3 50228-140 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20141029 ANDA ANDA203907 ScieGen Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 50231-311_ecf99f0e-4f44-48b6-9204-7571caf4dda3 50231-311 HUMAN OTC DRUG Medistik analgesic Menthol and Methyl Salicylate STICK TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part348 Natureteq Inc. MENTHOL; METHYL SALICYLATE 15; 30 g/100g; g/100g 50232-001_4c814f7d-72e6-4b93-9702-e21db1a727bc 50232-001 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20120514 OTC MONOGRAPH FINAL part344 BEIJING RUICHENG MEDICAL SUPPLIES CO., LTD. ISOPROPYL ALCOHOL .7 mL/mL 50236-001_41e7889e-a183-4fea-9e12-63052f878cc0 50236-001 HUMAN PRESCRIPTION DRUG Visudyne verteporfin for injection INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20000412 NDA NDA021119 QLT Ophthalmics, Inc. VERTEPORFIN 15 mg/1 Photoabsorption [MoA],Photoenhancer [EPC],Photosensitizing Activity [PE] 50241-011_1dd3bf4b-4372-489e-998c-4c1159c757bd 50241-011 HUMAN OTC DRUG MG DermaSan N/A LIQUID TOPICAL 20140131 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher Inc. BENZALKONIUM CHLORIDE .1 g/100g 50241-013_b200936f-f7b2-463c-a6b5-07a71e53878a 50241-013 HUMAN OTC DRUG MG DermaSan MG DermaSan LIQUID TOPICAL 20131203 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher Inc. BENZALKONIUM CHLORIDE .13 g/100g 50241-014_33ed3686-ff68-4ad3-ab83-9fa569ae6e8b 50241-014 HUMAN OTC DRUG MG DermaClean N/A LIQUID TOPICAL 20140203 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher Inc. BENZALKONIUM CHLORIDE .13 g/100g 50241-030_2dee0f59-7d36-4821-bc96-27de50b2045e 50241-030 HUMAN OTC DRUG MG DermaWash N/A LIQUID TOPICAL 20131211 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher Inc. CHLOROXYLENOL .3 g/100g 50241-141_ecf9e50b-b758-4638-9e71-725c7ffb8f0b 50241-141 HUMAN OTC DRUG Skyline Antibacterial Hand Cleanser parachlorometaxylenol LIQUID TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher, Inc. DBA Custom Chemical Formulators, Inc. CHLOROXYLENOL .3 kg/100kg 50241-142_7f574f6f-8aee-4534-ba22-cfd03d2aa7f9 50241-142 HUMAN OTC DRUG PROBLEND Antibacterial Foam Triclosan LIQUID TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher, Inc. DBA Custom Chemical Formulators, Inc. TRICLOSAN .3 kg/100kg 50241-143_c619396a-7a9a-4902-8c7c-66876e8d7193 50241-143 HUMAN OTC DRUG PROBLEND Antibacterial Liquid Cleanser Parachlorometaxylenol LIQUID TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher, Inc. DBA Custom Chemical Formulators, Inc. CHLOROXYLENOL .3 kg/100kg 50242-018_38f61741-b766-426c-a441-ba09198973da 50242-018 HUMAN PRESCRIPTION DRUG Nutropin Somatropin KIT 19931117 NDA NDA019676 Genentech, Inc. 50242-040_7fa51469-9f7e-4823-a160-93f04f2a55b4 50242-040 HUMAN PRESCRIPTION DRUG XOLAIR omalizumab INJECTION, SOLUTION SUBCUTANEOUS 20030620 BLA BLA103976 Genentech, Inc. OMALIZUMAB 202.5 mg/1.4mL Anti-IgE [EPC],Decreased IgE Activity [PE],IgE-directed Antibody Interactions [MoA] 50242-041_162fe6a5-4dc6-46b5-8206-24a0af55f2d1 50242-041 HUMAN PRESCRIPTION DRUG Cathflo Activase Alteplase INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010904 BLA BLA103172 Genentech, Inc. ALTEPLASE 2.2 mg/2mL 50242-043_e18cba5f-c533-4435-83ea-9cf3867ad56f 50242-043 HUMAN PRESCRIPTION DRUG Nutropin AQ Pen 10 somatropin (rDNA origin) INJECTION, SOLUTION SUBCUTANEOUS 19951229 NDA NDA020522 Genentech, Inc. SOMATROPIN 10 mg/2mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] 50242-044_2434c5f8-7027-46e0-a591-46ba1e09ed01 50242-044 HUMAN PRESCRIPTION DRUG Activase Alteplase KIT 19871113 BLA BLA103172 Genentech, Inc. 50242-051_c909e297-c14a-4c71-bc5d-9c3ee815de15 50242-051 HUMAN PRESCRIPTION DRUG Rituxan rituximab INJECTION, SOLUTION INTRAVENOUS 19971126 BLA BLA103705 Genentech, Inc. RITUXIMAB 10 mg/mL CD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC] 50242-053_c909e297-c14a-4c71-bc5d-9c3ee815de15 50242-053 HUMAN PRESCRIPTION DRUG Rituxan rituximab INJECTION, SOLUTION INTRAVENOUS 19971126 BLA BLA103705 Genentech, Inc. RITUXIMAB 10 mg/mL CD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC] 50242-060_3c83374a-b19e-471e-b448-ab946b6b97f5 50242-060 HUMAN PRESCRIPTION DRUG Avastin bevacizumab INJECTION, SOLUTION INTRAVENOUS 20040226 BLA BLA125085 Genentech, Inc. BEVACIZUMAB 100 mg/4mL Vascular Endothelial Growth Factor Receptor Inhibitors [MoA],Vascular Endothelial Growth Factor-directed Antibody [EPC],Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA] 50242-061_3c83374a-b19e-471e-b448-ab946b6b97f5 50242-061 HUMAN PRESCRIPTION DRUG Avastin bevacizumab INJECTION, SOLUTION INTRAVENOUS 20040226 BLA BLA125085 Genentech, Inc. BEVACIZUMAB 400 mg/16mL Vascular Endothelial Growth Factor Receptor Inhibitors [MoA],Vascular Endothelial Growth Factor-directed Antibody [EPC],Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA] 50242-062_acf5daa0-3882-4a75-9e2a-318fa1090ee1 50242-062 HUMAN PRESCRIPTION DRUG TARCEVA erlotinib hydrochloride TABLET ORAL 20050430 NDA NDA021743 Genentech, Inc. ERLOTINIB HYDROCHLORIDE 25 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 50242-063_acf5daa0-3882-4a75-9e2a-318fa1090ee1 50242-063 HUMAN PRESCRIPTION DRUG TARCEVA erlotinib hydrochloride TABLET ORAL 20050430 NDA NDA021743 Genentech, Inc. ERLOTINIB HYDROCHLORIDE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 50242-064_acf5daa0-3882-4a75-9e2a-318fa1090ee1 50242-064 HUMAN PRESCRIPTION DRUG TARCEVA erlotinib hydrochloride TABLET ORAL 20050430 NDA NDA021743 Genentech, Inc. ERLOTINIB HYDROCHLORIDE 150 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 50242-070_85e993c4-5914-434a-ac17-d56c815f9fee 50242-070 HUMAN PRESCRIPTION DRUG Gazyva obinutuzumab INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20131101 BLA BLA125486 Genentech, Inc. OBINUTUZUMAB 1000 mg/40mL CD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC] 50242-072_38f61741-b766-426c-a441-ba09198973da 50242-072 HUMAN PRESCRIPTION DRUG Nutropin Somatropin KIT 19931117 NDA NDA019676 Genentech, Inc. 50242-073_e18cba5f-c533-4435-83ea-9cf3867ad56f 50242-073 HUMAN PRESCRIPTION DRUG Nutropin AQ Pen 20 somatropin (rDNA origin) INJECTION, SOLUTION SUBCUTANEOUS 19951229 NDA NDA020522 Genentech, Inc. SOMATROPIN 20 mg/2mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] 50242-074_e18cba5f-c533-4435-83ea-9cf3867ad56f 50242-074 HUMAN PRESCRIPTION DRUG Nutropin AQ NuSpin 10 somatropin (rDNA origin) INJECTION, SOLUTION SUBCUTANEOUS 19951229 NDA NDA020522 Genentech, Inc. SOMATROPIN 10 mg/2mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] 50242-075_e18cba5f-c533-4435-83ea-9cf3867ad56f 50242-075 HUMAN PRESCRIPTION DRUG Nutropin AQ NuSpin 5 somatropin (rDNA origin) INJECTION, SOLUTION SUBCUTANEOUS 19951229 NDA NDA020522 Genentech, Inc. SOMATROPIN 5 mg/2mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] 50242-076_e18cba5f-c533-4435-83ea-9cf3867ad56f 50242-076 HUMAN PRESCRIPTION DRUG Nutropin AQ NuSpin 20 somatropin (rDNA origin) INJECTION, SOLUTION SUBCUTANEOUS 19951229 NDA NDA020522 Genentech, Inc. SOMATROPIN 20 mg/2mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] 50242-080_16cc39b1-60b4-47c2-8d88-89d5f0beacac 50242-080 HUMAN PRESCRIPTION DRUG LUCENTIS RANIBIZUMAB INJECTION, SOLUTION INTRAVITREAL 20060630 BLA BLA125156 Genentech, Inc. RANIBIZUMAB 10 mg/mL Vascular Endothelial Growth Factor Receptor Inhibitors [MoA],Vascular Endothelial Growth Factor-directed Antibody [EPC],Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA] 50242-082_16cc39b1-60b4-47c2-8d88-89d5f0beacac 50242-082 HUMAN PRESCRIPTION DRUG LUCENTIS RANIBIZUMAB INJECTION, SOLUTION INTRAVITREAL 20120810 BLA BLA125156 Genentech, Inc. RANIBIZUMAB 6 mg/mL Vascular Endothelial Growth Factor Receptor Inhibitors [MoA],Vascular Endothelial Growth Factor-directed Antibody [EPC],Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA] 50242-085_2434c5f8-7027-46e0-a591-46ba1e09ed01 50242-085 HUMAN PRESCRIPTION DRUG Activase Alteplase KIT 19871113 BLA BLA103172 Genentech, Inc. 50242-087_fb8d2f8a-fe11-475f-a201-629067a1487b 50242-087 HUMAN PRESCRIPTION DRUG KADCYLA ADO-TRASTUZUMAB EMTANSINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130222 BLA BLA125427 Genentech, Inc. ADO-TRASTUZUMAB EMTANSINE 20 mg/mL 50242-088_fb8d2f8a-fe11-475f-a201-629067a1487b 50242-088 HUMAN PRESCRIPTION DRUG KADCYLA ADO-TRASTUZUMAB EMTANSINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130222 BLA BLA125427 Genentech, Inc. ADO-TRASTUZUMAB EMTANSINE 20 mg/mL 50242-090_f52c4812-296d-40f2-880c-a04dd434d852 50242-090 HUMAN PRESCRIPTION DRUG ZELBORAF Vemurafenib TABLET, FILM COATED ORAL 20110817 NDA NDA202429 Genentech, Inc. VEMURAFENIB 240 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA] 50242-100_bfdc4184-23a2-47c8-be61-60aaa998ff77 50242-100 HUMAN PRESCRIPTION DRUG Pulmozyme dornase alfa SOLUTION RESPIRATORY (INHALATION) 19931230 BLA BLA103532 Genentech, Inc. DORNASE ALFA 1 mg/mL Decreased Respiratory Secretion Viscosity [PE],Deoxyribonuclease I [Chemical/Ingredient],Recombinant Human Deoxyribonuclease 1 [EPC],Recombinant Proteins [Chemical/Ingredient] 50242-120_1a9e312c-f0b0-4139-b526-b904b80883a4 50242-120 HUMAN PRESCRIPTION DRUG TNKase tenecteplase KIT 20000602 BLA BLA103909 Genentech, Inc. 50242-134_739a4f7c-5616-4a02-9210-2843c3c1e6bc 50242-134 HUMAN PRESCRIPTION DRUG Herceptin Trastuzumab KIT 19980925 BLA BLA103792 Genentech, Inc. 50242-135_2446e5e5-0e24-4a9d-bfc5-64f51cbb032b 50242-135 HUMAN PRESCRIPTION DRUG ACTEMRA tocilizumab INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100108 BLA BLA125276 Genentech, Inc. TOCILIZUMAB 20 mg/mL Interleukin 6 Receptor Antagonists [MoA],Interleukin-6 Receptor Antagonist [EPC] 50242-136_2446e5e5-0e24-4a9d-bfc5-64f51cbb032b 50242-136 HUMAN PRESCRIPTION DRUG ACTEMRA tocilizumab INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100108 BLA BLA125276 Genentech, Inc. TOCILIZUMAB 20 mg/mL Interleukin 6 Receptor Antagonists [MoA],Interleukin-6 Receptor Antagonist [EPC] 50242-137_2446e5e5-0e24-4a9d-bfc5-64f51cbb032b 50242-137 HUMAN PRESCRIPTION DRUG ACTEMRA tocilizumab INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100108 BLA BLA125276 Genentech, Inc. TOCILIZUMAB 20 mg/mL Interleukin 6 Receptor Antagonists [MoA],Interleukin-6 Receptor Antagonist [EPC] 50242-138_2446e5e5-0e24-4a9d-bfc5-64f51cbb032b 50242-138 HUMAN PRESCRIPTION DRUG Actemra tocilizumab INJECTION, SOLUTION SUBCUTANEOUS 20131021 BLA BLA125472 Genentech, Inc. TOCILIZUMAB 180 mg/mL Interleukin 6 Receptor Antagonists [MoA],Interleukin-6 Receptor Antagonist [EPC] 50242-140_760abb05-064b-4ae6-9cba-0f53f99ac29d 50242-140 HUMAN PRESCRIPTION DRUG ERIVEDGE vismodegib CAPSULE ORAL 20120130 NDA NDA203388 Genentech, Inc. VISMODEGIB 150 mg/1 Hedgehog Pathway Inhibitor [EPC],Smoothened Receptor Antagonists [MoA] 50242-145_2bb8040b-6ff0-49ce-8cb9-9912e98899c0 50242-145 HUMAN PRESCRIPTION DRUG PERJETA Pertuzumab INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20120608 BLA BLA125409 Genentech, Inc. PERTUZUMAB 30 mg/mL HER2 Receptor Antagonist [EPC],HER2/Neu/cerbB2 Antagonists [MoA] 50246-100_90e147c3-21fc-48b2-8e0d-06ddf7d2f45c 50246-100 HUMAN OTC DRUG Ultra Care-aid Sanitizer Antiseptic Hand Sanitizer Citric Fragrance with Aloe Vera ALCOHOL GEL TOPICAL 20100208 OTC MONOGRAPH FINAL part333 Aromaticos Quimicos Potosinos, S.A. de C.V. ALCOHOL 62 mL/100mL 50254-773_e3a89587-cb6a-4b7b-9a02-442edb088622 50254-773 HUMAN OTC DRUG Germ Bullet ALCOHOL AEROSOL, FOAM TOPICAL 20091031 OTC MONOGRAPH NOT FINAL part333 Beaver Research Company ALCOHOL 620 mg/g 50260-200_4a6a41af-8bad-4153-a8c0-b410f1455fad 50260-200 HUMAN OTC DRUG HAND SANITIZER HAND SANITIZER GEL PERCUTANEOUS 20100201 OTC MONOGRAPH FINAL part348 Fercy Personal Care Products Co Limited ALCOHOL 62 mL/100mL 50260-300_e8881780-74bb-481a-b58a-31b9d2a04e3a 50260-300 HUMAN OTC DRUG HAND SANITIZER ALCOHOL FREE ALCOHOL FREE HAND SANITIZER GEL PERCUTANEOUS 20100406 OTC MONOGRAPH FINAL part348 Fercy Personal Care Products Co Limited TRICLOSAN 2 mL/100mL 50260-500_f8575e6b-5930-40de-bf98-0f141fc508c8 50260-500 HUMAN OTC DRUG NON ALCOHOL HAND SANITIZER Benzalkonium Chloride GEL TOPICAL 20101113 OTC MONOGRAPH NOT FINAL part333A Fercy Personal Care Products Co Limited BENZALKONIUM CHLORIDE .1 mL/100mL 50260-800_6033f19a-bfc6-494f-89ca-efb8b0a7ed8d 50260-800 HUMAN OTC DRUG Lip Balm SPF 15 Octinoxate OXYBENZONE OINTMENT TOPICAL 20101209 OTC MONOGRAPH FINAL part352 Fercy Personal Care Products Co Limited OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 50268-050_59c8b781-b2ce-a42c-75d9-207e1a35c819 50268-050 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20091201 ANDA ANDA075047 AvPAK ACEBUTOLOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50268-051_59c8b781-b2ce-a42c-75d9-207e1a35c819 50268-051 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20091201 ANDA ANDA075047 AvPAK ACEBUTOLOL HYDROCHLORIDE 400 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50268-060_3ef5c15c-04ed-cc45-c51e-2570e0d04a9b 50268-060 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20130502 ANDA ANDA075090 AvPAK ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 50268-061_d7b2d8a6-05fb-218e-81c7-09a02b6a0605 50268-061 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19990305 ANDA ANDA075382 AvPAK ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 50268-062_d7b2d8a6-05fb-218e-81c7-09a02b6a0605 50268-062 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20140718 ANDA ANDA075382 AvPAK ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 50268-069_b304f150-e010-0c4d-6a19-2a9cf93b3d12 50268-069 HUMAN PRESCRIPTION DRUG Amantadine HCl AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140328 ANDA ANDA078720 AvPAK AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 50268-071_095ba355-6e91-d35a-3254-8b94d6fa0ec8 50268-071 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride Amiloride Hydrochloride TABLET ORAL 20130128 ANDA ANDA079133 AvPAK AMILORIDE HYDROCHLORIDE 5 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 50268-081_b5501b59-1080-d83c-bf78-17ffb3f9e335 50268-081 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110607 ANDA ANDA078500 AvPAK AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50268-082_b5501b59-1080-d83c-bf78-17ffb3f9e335 50268-082 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110607 ANDA ANDA078500 AvPAK AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50268-083_705c6d5b-7de9-f7df-a29b-78ecc3915e72 50268-083 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140110 ANDA ANDA078552 AvPAK AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50268-084_705c6d5b-7de9-f7df-a29b-78ecc3915e72 50268-084 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140110 ANDA ANDA078552 AvPAK AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50268-085_705c6d5b-7de9-f7df-a29b-78ecc3915e72 50268-085 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140110 ANDA ANDA078552 AvPAK AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50268-098_4fa9172b-f2e6-81af-451d-6c813b005fe0 50268-098 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20110520 ANDA ANDA065404 AvPAK AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 50268-099_4fa9172b-f2e6-81af-451d-6c813b005fe0 50268-099 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20110520 ANDA ANDA065405 AvPAK AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 50268-100_d42887e4-78bd-b09c-72a6-1e3d7e123e1f 50268-100 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20140326 ANDA ANDA065507 AvPAK AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 50268-101_d42887e4-78bd-b09c-72a6-1e3d7e123e1f 50268-101 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20140326 ANDA ANDA065509 AvPAK AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 50268-102_98ab4c37-72f9-61d0-25b9-cb41c956c9e1 50268-102 HUMAN PRESCRIPTION DRUG Balsalazide Disodium Balsalazide Disodium CAPSULE ORAL 20141106 ANDA ANDA077883 AvPAK BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 50268-109_dfbf6fef-a824-25a2-6006-083e52f01829 50268-109 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20140414 ANDA ANDA076820 AvPAK BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 50268-110_dfbf6fef-a824-25a2-6006-083e52f01829 50268-110 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20140415 ANDA ANDA076820 AvPAK BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 50268-111_dfbf6fef-a824-25a2-6006-083e52f01829 50268-111 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20140415 ANDA ANDA076820 AvPAK BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 50268-112_dfbf6fef-a824-25a2-6006-083e52f01829 50268-112 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20140415 ANDA ANDA076820 AvPAK BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 50268-113_22130d92-7f4f-f25c-94bb-417052e87327 50268-113 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20070111 ANDA ANDA040855 AvPAK BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 50268-114_22130d92-7f4f-f25c-94bb-417052e87327 50268-114 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20070111 ANDA ANDA040855 AvPAK BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 50268-151_645f74cb-a06a-c617-64f6-8edf5a406c1e 50268-151 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20140912 ANDA ANDA090836 AvPAK CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 50268-152_645f74cb-a06a-c617-64f6-8edf5a406c1e 50268-152 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20140912 ANDA ANDA090836 AvPAK CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 50268-161_6c510f7d-1da0-81f2-f490-837536452eb1 50268-161 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20141016 ANDA ANDA077498 AvPAK CETIRIZINE HYDROCHLORIDE 10 mg/1 50268-180_05880c4a-3c68-709f-c917-6016b79cf2a0 50268-180 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140715 ANDA ANDA065442 AvPAK CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 50268-181_05880c4a-3c68-709f-c917-6016b79cf2a0 50268-181 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140715 ANDA ANDA065442 AvPAK CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 50268-190_004752c6-7c2b-b33c-4077-6712ceeb16b5 50268-190 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20140610 ANDA ANDA090478 AvPAK CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 50268-219_d589c667-a96d-fc4e-a5a0-dca7cc7b23c1 50268-219 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET ORAL 20131009 ANDA ANDA078355 AvPAK DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 50268-220_21174971-6cf2-c95c-1311-53db61b8fd62 50268-220 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20130724 ANDA ANDA076470 AvPAK DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 50268-221_21174971-6cf2-c95c-1311-53db61b8fd62 50268-221 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20130724 ANDA ANDA076470 AvPAK DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 50268-263_e19deeae-b20b-3ccd-fd40-4cd0b65f54c3 50268-263 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20070805 ANDA ANDA040782 AvPAK DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 50268-264_e19deeae-b20b-3ccd-fd40-4cd0b65f54c3 50268-264 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20110805 ANDA ANDA040782 AvPAK DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 50268-265_e19deeae-b20b-3ccd-fd40-4cd0b65f54c3 50268-265 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20110805 ANDA ANDA040782 AvPAK DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 50268-277_7bd8f46f-3bd1-4409-931c-d3b3228410d7 50268-277 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20140605 ANDA ANDA062675 AvPAK DOXYCYCLINE HYCLATE 50 mg/1 50268-278_7bd8f46f-3bd1-4409-931c-d3b3228410d7 50268-278 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20140605 ANDA ANDA062676 AvPAK DOXYCYCLINE HYCLATE 100 mg/1 50268-279_7bd8f46f-3bd1-4409-931c-d3b3228410d7 50268-279 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20140605 ANDA ANDA062677 AvPAK DOXYCYCLINE HYCLATE 100 mg/1 50268-290_a178389c-c1b5-0dea-32b8-09ff41700cd8 50268-290 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20140212 ANDA ANDA040114 AvPAK ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 50268-291_a178389c-c1b5-0dea-32b8-09ff41700cd8 50268-291 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20140212 ANDA ANDA040114 AvPAK ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 50268-292_a178389c-c1b5-0dea-32b8-09ff41700cd8 50268-292 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20140212 ANDA ANDA040114 AvPAK ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 50268-303_ef8b2ebc-08d8-6596-d328-5de0b0967c33 50268-303 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20141006 ANDA ANDA075805 AvPAK FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 50268-304_ef8b2ebc-08d8-6596-d328-5de0b0967c33 50268-304 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20141006 ANDA ANDA075805 AvPAK FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 50268-305_79438060-ffdd-b240-40e5-f4a4320395a0 50268-305 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20130516 ANDA ANDA201022 AvPAK FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 50268-306_79438060-ffdd-b240-40e5-f4a4320395a0 50268-306 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20130516 ANDA ANDA201022 AvPAK FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 50268-307_79438060-ffdd-b240-40e5-f4a4320395a0 50268-307 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20130516 ANDA ANDA201022 AvPAK FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 50268-323_3f387243-303f-70d2-a48a-6dc048b06139 50268-323 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20070328 ANDA ANDA077914 AvPAK FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 50268-324_267b9e91-a7ba-ee5a-508a-9a6182160831 50268-324 HUMAN PRESCRIPTION DRUG Flavoxate Hydrochloride Flavoxate Hydrochloride TABLET ORAL 20121130 ANDA ANDA076835 AvPAK FLAVOXATE HYDROCHLORIDE 100 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 50268-330_3f019916-4d94-c555-ad1a-e9387a3c8ccf 50268-330 HUMAN PRESCRIPTION DRUG FLUDROCORTISONE ACETATE FLUDROCORTISONE ACETATE TABLET ORAL 20110801 ANDA ANDA040431 AvPAK FLUDROCORTISONE ACETATE .1 mg/1 50268-333_03472d45-03de-de19-7864-34619df38053 50268-333 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20140820 ANDA ANDA078619 AvPAK FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50268-334_03472d45-03de-de19-7864-34619df38053 50268-334 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20140820 ANDA ANDA078619 AvPAK FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50268-335_03472d45-03de-de19-7864-34619df38053 50268-335 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20140820 ANDA ANDA078619 AvPAK FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50268-345_0d12eeea-3a42-8630-7131-0873fb2ebae4 50268-345 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20050722 ANDA ANDA040625 AvPAK FOLIC ACID 1 mg/1 50268-347_ef132f58-14d2-6402-a9be-16e4d1814f76 50268-347 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20140915 ANDA ANDA090007 AvPAK GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50268-348_ef132f58-14d2-6402-a9be-16e4d1814f76 50268-348 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20140915 ANDA ANDA090007 AvPAK GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50268-349_ef132f58-14d2-6402-a9be-16e4d1814f76 50268-349 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20140915 ANDA ANDA090007 AvPAK GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50268-350_b396cf16-07b6-d633-6cf2-a91bc2335e64 50268-350 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20140710 ANDA ANDA077836 AvPAK GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 50268-401_81f1c1d8-7112-a501-1014-a239b1f04ed6 50268-401 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140915 ANDA ANDA040736 AvPAK ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50268-402_81f1c1d8-7112-a501-1014-a239b1f04ed6 50268-402 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140915 ANDA ANDA040746 AvPAK ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50268-403_3e80d531-a8db-9272-b01c-0ec8453c8bc2 50268-403 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20060825 20160531 ANDA ANDA040736 AvPAK ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50268-408_3e80d531-a8db-9272-b01c-0ec8453c8bc2 50268-408 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20060825 20160531 ANDA ANDA040746 AvPAK ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50268-451_3d46b4ed-639a-63cc-8279-795d76bb1b60 50268-451 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20121213 ANDA ANDA075155 AvPAK ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 50268-452_3d46b4ed-639a-63cc-8279-795d76bb1b60 50268-452 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20121213 ANDA ANDA075155 AvPAK ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 50268-453_3d46b4ed-639a-63cc-8279-795d76bb1b60 50268-453 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20140428 ANDA ANDA075155 AvPAK ISOSORBIDE MONONITRATE 120 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 50268-454_35cacb47-8c18-14b0-8c68-cc96f03cc318 50268-454 HUMAN PRESCRIPTION DRUG Isradipine Isradipine CAPSULE ORAL 20140106 ANDA ANDA077317 AvPAK ISRADIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50268-455_35cacb47-8c18-14b0-8c68-cc96f03cc318 50268-455 HUMAN PRESCRIPTION DRUG Isradipine Isradipine CAPSULE ORAL 20140106 ANDA ANDA077317 AvPAK ISRADIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50268-467_e5786804-d588-c114-bcbb-f218f69331f8 50268-467 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090320 ANDA ANDA077319 AvPAK LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50268-468_e5786804-d588-c114-bcbb-f218f69331f8 50268-468 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090320 ANDA ANDA077319 AvPAK LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50268-469_e5786804-d588-c114-bcbb-f218f69331f8 50268-469 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090320 ANDA ANDA077319 AvPAK LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50268-485_26b52d44-069e-d3df-3cc9-e598b8ea2f8a 50268-485 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20141001 ANDA ANDA076497 AvPAK LOPERAMIDE HYDROCHLORIDE 2 mg/1 50268-507_f112e592-6521-013f-52fb-b8cafad90a42 50268-507 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110602 ANDA ANDA071403 AvPAK LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50268-508_f112e592-6521-013f-52fb-b8cafad90a42 50268-508 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110602 ANDA ANDA071404 AvPAK LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50268-509_f112e592-6521-013f-52fb-b8cafad90a42 50268-509 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110602 ANDA ANDA071141 AvPAK LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50268-510_0e02b2e2-5fb5-89cc-d89d-4bb813a0e946 50268-510 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140429 ANDA ANDA075991 AvPAK LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50268-511_0e02b2e2-5fb5-89cc-d89d-4bb813a0e946 50268-511 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140429 ANDA ANDA075991 AvPAK LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50268-512_0e02b2e2-5fb5-89cc-d89d-4bb813a0e946 50268-512 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140429 ANDA ANDA075991 AvPAK LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50268-513_0b997049-21d2-5bf9-ed1c-eb2a098af150 50268-513 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20140328 ANDA ANDA090528 AvPAK HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 50268-514_0b997049-21d2-5bf9-ed1c-eb2a098af150 50268-514 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20140328 ANDA ANDA090528 AvPAK HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 50268-515_0b997049-21d2-5bf9-ed1c-eb2a098af150 50268-515 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20140328 ANDA ANDA090528 AvPAK HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 50268-516_07da41d7-f958-dfe4-9411-77182e8b9fd0 50268-516 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20140327 ANDA ANDA090467 AvPAK LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 50268-517_07da41d7-f958-dfe4-9411-77182e8b9fd0 50268-517 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20140327 ANDA ANDA090467 AvPAK LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 50268-518_07da41d7-f958-dfe4-9411-77182e8b9fd0 50268-518 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20140327 ANDA ANDA090467 AvPAK LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 50268-522_fa653e96-da55-1353-94d3-3a94a9ab4192 50268-522 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20130808 ANDA ANDA201451 AvPAK MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 50268-523_fa653e96-da55-1353-94d3-3a94a9ab4192 50268-523 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20130808 ANDA ANDA201451 AvPAK MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 50268-525_6ff6ea10-1f86-68e3-4728-ce18d41576ae 50268-525 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20121009 ANDA ANDA077918 AvPAK MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50268-526_6ff6ea10-1f86-68e3-4728-ce18d41576ae 50268-526 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20121009 ANDA ANDA077918 AvPAK MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50268-531_2321f24b-7592-c4eb-344d-549653ac5f37 50268-531 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091202 ANDA ANDA078596 AvPAK METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 50268-532_2321f24b-7592-c4eb-344d-549653ac5f37 50268-532 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141112 ANDA ANDA078596 AvPAK METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 50268-536_de659d15-2863-3d4f-063c-a51d6a6b9623 50268-536 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20141020 ANDA ANDA086989 AvPAK METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 50268-537_de659d15-2863-3d4f-063c-a51d6a6b9623 50268-537 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20141020 ANDA ANDA086988 AvPAK METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 50268-564_04e9adc6-4572-204f-3143-a900d4d0694b 50268-564 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20110817 ANDA ANDA076449 AvPAK MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 50268-565_04e9adc6-4572-204f-3143-a900d4d0694b 50268-565 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20110817 ANDA ANDA076449 AvPAK MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 50268-566_04e9adc6-4572-204f-3143-a900d4d0694b 50268-566 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20110817 ANDA ANDA076449 AvPAK MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 50268-569_a83e9377-47a2-b653-361b-feedad62d61a 50268-569 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20141107 ANDA ANDA063065 AvPAK MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 50268-573_bd71531f-ce41-f5fb-456a-559f4b67e43f 50268-573 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20141111 ANDA ANDA200405 AvPAK MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 50268-574_bd71531f-ce41-f5fb-456a-559f4b67e43f 50268-574 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20141112 ANDA ANDA200405 AvPAK MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 50268-575_bd71531f-ce41-f5fb-456a-559f4b67e43f 50268-575 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20141002 ANDA ANDA201522 AvPAK MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 50268-592_afdfe4a5-3b89-7962-8b4c-3eb7fac569bf 50268-592 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20121011 ANDA ANDA078432 AvPAK NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50268-593_afdfe4a5-3b89-7962-8b4c-3eb7fac569bf 50268-593 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20121011 ANDA ANDA078432 AvPAK NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50268-597_cfe4585b-bf25-71d0-3c59-2d5e370f3b08 50268-597 HUMAN PRESCRIPTION DRUG Nifedipine ER Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 AvPAK NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50268-598_cfe4585b-bf25-71d0-3c59-2d5e370f3b08 50268-598 HUMAN PRESCRIPTION DRUG Nifedipine ER Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 AvPAK NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50268-599_cfe4585b-bf25-71d0-3c59-2d5e370f3b08 50268-599 HUMAN PRESCRIPTION DRUG Nifedipine ER Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20071003 ANDA ANDA077410 AvPAK NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50268-602_7759504e-becc-af06-7d44-c2f91ce0991a 50268-602 HUMAN PRESCRIPTION DRUG Norethindrone Acetate Norethindrone TABLET ORAL 20141117 ANDA ANDA200275 AvPAK NORETHINDRONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 50268-615_6c444ed9-3031-cbd3-bda4-96eca3ed1d86 50268-615 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140417 ANDA ANDA091415 AvPAK OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 50268-616_6c444ed9-3031-cbd3-bda4-96eca3ed1d86 50268-616 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140417 ANDA ANDA091415 AvPAK OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 50268-617_6c444ed9-3031-cbd3-bda4-96eca3ed1d86 50268-617 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140417 ANDA ANDA091415 AvPAK OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 50268-618_6c444ed9-3031-cbd3-bda4-96eca3ed1d86 50268-618 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140417 ANDA ANDA091415 AvPAK OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 50268-619_670ed47c-d2f6-b9e9-7941-fd9794856058 50268-619 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20110711 ANDA ANDA075410 AvPAK OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 50268-620_670ed47c-d2f6-b9e9-7941-fd9794856058 50268-620 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20110711 ANDA ANDA075410 AvPAK OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 50268-627_64fccb01-13c3-7153-6051-1cb4e8b057ab 50268-627 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20120517 ANDA ANDA078503 AvPAK OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 50268-628_64fccb01-13c3-7153-6051-1cb4e8b057ab 50268-628 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20120517 ANDA ANDA078503 AvPAK OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 50268-629_64fccb01-13c3-7153-6051-1cb4e8b057ab 50268-629 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20120516 ANDA ANDA078503 AvPAK OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 50268-636_54c2c40c-cf3e-fef1-44f9-bf568179432b 50268-636 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20130115 ANDA ANDA078281 AvPAK PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 50268-637_54c2c40c-cf3e-fef1-44f9-bf568179432b 50268-637 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20130115 ANDA ANDA078281 AvPAK PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 50268-660_766f4056-9790-41a4-de7e-98c3a9aec7ff 50268-660 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Extended Phenytoin Sodium CAPSULE ORAL 20091216 ANDA ANDA040765 AvPAK PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50268-686_5eadf79c-1cb0-2c15-68f4-f1fde2db5855 50268-686 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20110519 ANDA ANDA040866 AvPAK PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50268-687_5eadf79c-1cb0-2c15-68f4-f1fde2db5855 50268-687 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20110519 ANDA ANDA040866 AvPAK PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50268-688_b39c3921-8095-12dd-452a-190fbe5f1312 50268-688 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20140805 ANDA ANDA078457 AvPAK QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50268-689_b39c3921-8095-12dd-452a-190fbe5f1312 50268-689 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20140805 ANDA ANDA078457 AvPAK QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50268-690_b39c3921-8095-12dd-452a-190fbe5f1312 50268-690 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20140805 ANDA ANDA078457 AvPAK QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50268-691_b39c3921-8095-12dd-452a-190fbe5f1312 50268-691 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20140805 ANDA ANDA078457 AvPAK QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50268-695_21297bd2-00b8-21de-de4d-0dbabd18511f 50268-695 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20140827 ANDA ANDA078040 AvPAK RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 50268-696_21297bd2-00b8-21de-de4d-0dbabd18511f 50268-696 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20140827 ANDA ANDA078040 AvPAK RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 50268-697_21297bd2-00b8-21de-de4d-0dbabd18511f 50268-697 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20140827 ANDA ANDA078040 AvPAK RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 50268-698_21297bd2-00b8-21de-de4d-0dbabd18511f 50268-698 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20140827 ANDA ANDA078040 AvPAK RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 50268-699_21297bd2-00b8-21de-de4d-0dbabd18511f 50268-699 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20140827 ANDA ANDA078040 AvPAK RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 50268-704_49e0a187-9d7d-09a3-339a-2492432ecf0b 50268-704 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20141118 UNAPPROVED DRUG OTHER AvPAK SALSALATE 500 mg/1 50268-705_49e0a187-9d7d-09a3-339a-2492432ecf0b 50268-705 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20141118 UNAPPROVED DRUG OTHER AvPAK SALSALATE 750 mg/1 50268-712_d211da8e-f9e8-c418-6e50-fed6b9136f86 50268-712 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141202 ANDA ANDA077691 AvPAK SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50268-713_d211da8e-f9e8-c418-6e50-fed6b9136f86 50268-713 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141202 ANDA ANDA077691 AvPAK SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50268-714_d211da8e-f9e8-c418-6e50-fed6b9136f86 50268-714 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141202 ANDA ANDA077691 AvPAK SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50268-715_d211da8e-f9e8-c418-6e50-fed6b9136f86 50268-715 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141202 ANDA ANDA077691 AvPAK SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50268-716_d211da8e-f9e8-c418-6e50-fed6b9136f86 50268-716 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141202 ANDA ANDA077691 AvPAK SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50268-726_a26bb6b1-f0d3-4d30-220e-d1c6ee14e7c7 50268-726 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20110519 ANDA ANDA040353 AvPAK SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 50268-728_8faea049-4465-ca88-e1d2-7b81d152c2cd 50268-728 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20140923 ANDA ANDA090624 AvPAK SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 50268-729_8faea049-4465-ca88-e1d2-7b81d152c2cd 50268-729 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20140923 ANDA ANDA090624 AvPAK SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 50268-730_11e7b169-220e-6b25-8769-11d8fd31cb44 50268-730 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20140114 ANDA ANDA085828 AvPAK SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 50268-750_8104ad24-134f-36bb-6ea5-94fe4c752c2c 50268-750 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140917 ANDA ANDA079162 AvPAK TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50268-751_8104ad24-134f-36bb-6ea5-94fe4c752c2c 50268-751 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140917 ANDA ANDA079162 AvPAK TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50268-752_8104ad24-134f-36bb-6ea5-94fe4c752c2c 50268-752 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140917 ANDA ANDA079162 AvPAK TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50268-753_8104ad24-134f-36bb-6ea5-94fe4c752c2c 50268-753 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140917 ANDA ANDA079162 AvPAK TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50268-754_1ffb99da-a666-3823-0d58-dd29fb80cf76 50268-754 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20141007 ANDA ANDA079234 AvPAK TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 50268-755_1ffb99da-a666-3823-0d58-dd29fb80cf76 50268-755 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20141007 ANDA ANDA079234 AvPAK TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 50268-756_1ffb99da-a666-3823-0d58-dd29fb80cf76 50268-756 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20141007 ANDA ANDA079234 AvPAK TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 50268-757_1ffb99da-a666-3823-0d58-dd29fb80cf76 50268-757 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20141007 ANDA ANDA079234 AvPAK TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 50268-775_60fe1c72-6583-8bf3-c896-c983485a78ca 50268-775 HUMAN PRESCRIPTION DRUG Trimethoprim Trimethoprim TABLET ORAL 20130731 ANDA ANDA070049 AvPAK TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 50268-788_b9415153-0008-74c7-353d-958c42faea22 50268-788 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20140922 ANDA ANDA090682 AvPAK VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 50268-789_b9415153-0008-74c7-353d-958c42faea22 50268-789 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20140922 ANDA ANDA090682 AvPAK VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 50268-795_541a38e3-557f-48cf-8126-8f5a75e76052 50268-795 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20090101 ANDA ANDA079082 AvPAK URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 50268-796_e860e5ae-3f1f-0ec6-61ea-0d522a3297c3 50268-796 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20120725 ANDA ANDA075517 AvPAK URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 50268-815_6dc4da7a-d719-25dd-830b-fd5ed2cc31d8 50268-815 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077636 AvPAK ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50268-816_bd79fbee-efac-efe2-0561-dc67221b22ca 50268-816 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20140702 ANDA ANDA077869 AvPAK ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50269-100_b9d8cc79-a217-4e03-b1e4-0f6e289e5fea 50269-100 HUMAN OTC DRUG Clara Instant Waterless Hand Sanitizer ALCOHOL GEL TOPICAL 20100209 OTC MONOGRAPH FINAL part333 JC World Bell Wholesale Co., Inc ALCOHOL 65 mL/100mL 50269-201_37dc85cb-aefb-440c-a79e-c22839aed29f 50269-201 HUMAN OTC DRUG Aleve Caplets NAPROXEN SODIUM TABLET ORAL 20140714 NDA NDA020204 JC World Bell Wholesale Co., Inc. NAPROXEN SODIUM 220 mg/1 50269-204_e974cbc4-fc87-4d79-b124-4baa62c76cff 50269-204 HUMAN OTC DRUG Midol Complete ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE TABLET ORAL 20140714 OTC MONOGRAPH NOT FINAL part343 JC World Bell Wholesale Co., Inc. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 50289-3250_bc28ef5d-20c3-44cb-8c98-95be042379eb 50289-3250 HUMAN OTC DRUG AER Pre-moistened Witch Hazel Pad Witch Hazel SOLUTION RECTAL; TOPICAL 20111230 OTC MONOGRAPH FINAL part346 Birchwood Laboratories Inc WITCH HAZEL .5 mL/mL 50289-9250_d8238a39-7224-4782-946c-a17e5154a571 50289-9250 HUMAN OTC DRUG B-SURE Traveler Towelette B-SURE Traveler SOLUTION RECTAL; TOPICAL 20080701 OTC MONOGRAPH FINAL part346 Birchwood Laboratories Inc WITCH HAZEL .5 g/g 50297-0001_ef71b5ba-5eb0-4ffc-9613-20da97a66395 50297-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090730 UNAPPROVED MEDICAL GAS Pure Oxygen Services OXYGEN 99 L/100L 50300-010_a9135b18-5e61-495f-a1f6-f5e6149b5a0a 50300-010 HUMAN OTC DRUG GOONG MAHN GEUM BENZALKONIUM CHLORIDE PILL VAGINAL 20120301 OTC MONOGRAPH NOT FINAL part333A CHUNG SOL BENZALKONIUM CHLORIDE .003 g/1 50302-100_00c18c7f-e8de-4fc5-a1e3-6b8b7588b9c9 50302-100 HUMAN OTC DRUG Panrosa Antibacterial Hand With Moisturizers TRICLOSAN SOAP TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part333A Panrosa Enterprises, Inc. TRICLOSAN 1.5 mg/mL 50302-200_0ecc9f16-c011-404e-92af-33eb90282b30 50302-200 HUMAN OTC DRUG Panrosa Instant Antiseptic Hand Sanitizer With Moisturizers ALCOHOL GEL TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part333A Panrosa Enterprises, Inc. ALCOHOL 62 mL/100mL 50302-300_24e51fec-57f8-4582-ad0b-e3233c774a61 50302-300 HUMAN OTC DRUG PANROSA Green Apple Scented Hand TRICLOSAN SOAP TOPICAL 20101210 OTC MONOGRAPH NOT FINAL part333A Panrosa Enterprises, Inc. TRICLOSAN .115 mL/100mL 50302-310_f8aea317-174f-4279-8801-67bff33f75a8 50302-310 HUMAN OTC DRUG PANROSA Honey Scented Hand TRICLOSAN SOAP TOPICAL 20101210 OTC MONOGRAPH NOT FINAL part333A Panrosa Enterprises, Inc. TRICLOSAN .115 mL/100mL 50302-320_99a01a8f-3128-4249-8143-5fce3f93d2bc 50302-320 HUMAN OTC DRUG PANROSA Lavender Scented Hand TRICLOSAN SOAP TOPICAL 20101210 OTC MONOGRAPH NOT FINAL part333A Panrosa Enterprises, Inc. TRICLOSAN .115 mL/100mL 50302-330_55e1c338-42ea-45cc-8264-507d7f117343 50302-330 HUMAN OTC DRUG PANROSA Rose Scented Hand TRICLOSAN SOAP TOPICAL 20101210 OTC MONOGRAPH NOT FINAL part333A Panrosa Enterprises, Inc. TRICLOSAN .115 mL/100mL 50302-340_8c5b3ed8-aef3-48ad-b5e7-a5f218e17e3d 50302-340 HUMAN OTC DRUG PANROSA Antibacterial Hand TRICLOSAN SOAP TOPICAL 20101210 OTC MONOGRAPH NOT FINAL part333A Panrosa Enterprises, Inc. TRICLOSAN .15 mL/100mL 50302-400_cc88fdb3-d040-4878-87f9-4d415607896b 50302-400 HUMAN OTC DRUG Panrosa FRESH CLEAN Pyrithione Zinc Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20130301 OTC MONOGRAPH FINAL part358H Panrosa Enterprises, Inc. PYRITHIONE ZINC 10 mg/mL 50305-120_6f4aa252-aee6-485e-ab23-10e074e87d8c 50305-120 HUMAN OTC DRUG Labsco Sterile Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20120503 OTC MONOGRAPH FINAL part344 Laboratory Supply Company ISOPROPYL ALCOHOL .7 mL/mL 50308-001_8bf9e434-f0d6-46c5-8630-8b2720032d30 50308-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19500101 UNAPPROVED MEDICAL GAS Ohio Air Products of Canton, Inc. OXYGEN 990 mL/L 50309-777_8d0e5e63-2766-4a91-98a7-a4e203a1a6f5 50309-777 HUMAN OTC DRUG Pain Relieving Patch MENTHOL PATCH TOPICAL 20100130 OTC MONOGRAPH NOT FINAL part348 Heilongjiang Huashen Science & Technology Development Co Ltd MENTHOL .2 1/1 50320-111_9514da65-6c4b-4d24-a764-fdfac847680d 50320-111 HUMAN OTC DRUG Monk Hand Sanitizing Wipes Benzethonium Chloride CLOTH TOPICAL 20100106 OTC MONOGRAPH NOT FINAL part333 National Towelette Company BENZETHONIUM CHLORIDE 30 mL/1000mL 50322-003_98ef5b4c-53a3-4f06-bc87-377176e17fea 50322-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20090101 NDA NDA205866 C & C Oxygen Company NITROGEN 990 mL/L 50322-005_aa387881-6895-4b5c-a62e-8d90dda6956e 50322-005 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091210 NDA NDA205865 C & C Oxygen Company OXYGEN 990 mL/L 50332-0029_ef848a1c-6ea9-44d9-a5da-e0554a133ee0 50332-0029 HUMAN OTC DRUG Blistex Lip dimethicone, camphor, menthol, phenol OINTMENT TOPICAL 19950809 OTC MONOGRAPH NOT FINAL part348 HART Health CAMPHOR OIL; DIMETHICONE; MENTHOL; PHENOL .5; 1.1; .6; .5 g/100g; g/100g; g/100g; g/100g 50332-0031_a9857098-f25d-46e2-91d9-82c3fecf8c28 50332-0031 HUMAN OTC DRUG TRIBIOTICLC LC LC BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE OINTMENT TOPICAL 20120504 OTC MONOGRAPH FINAL part333B HART Health BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 40; 5; 5000 1/g; mg/g; mg/g; 1/g 50332-0032_42ef4a98-b629-4cbb-ad6d-2bf06cb0d7c3 50332-0032 HUMAN OTC DRUG TRIBIOTIC BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE OINTMENT TOPICAL 20051003 OTC MONOGRAPH FINAL part333B HART Health BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 1/g; mg/g; 1/g 50332-0042_72700593-9738-4fb2-9846-70774c3e1846 50332-0042 HUMAN OTC DRUG HYDROCORTISONE HYDROCORTISONE ACETATE CREAM TOPICAL 19900130 OTC MONOGRAPH NOT FINAL part348 HART Health HYDROCORTISONE ACETATE 10 mg/g 50332-0102_bc2b8b1e-0402-4d4c-ad0f-edeafeb8f44c 50332-0102 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET ORAL 19860604 OTC MONOGRAPH FINAL part343 HART Health ASPIRIN 325 mg/1 50332-0103_c8feb7bc-c862-489b-9d88-6cca7bc3588a 50332-0103 HUMAN OTC DRUG CETAFEN ACETAMINOPHEN TABLET ORAL 19860604 OTC MONOGRAPH NOT FINAL part343 HART Health ACETAMINOPHEN 325 mg/1 50332-0105_16b4d71a-fead-491a-b5dc-a170f5c96dd8 50332-0105 HUMAN OTC DRUG EXAPRIN acetaminophen, aspirin, caffeine, salicylamide TABLET ORAL 19870120 OTC MONOGRAPH NOT FINAL part343 HART Health ACETAMINOPHEN; ASPIRIN; CAFFEINE; SALICYLAMIDE 110; 162; 32.4; 152 mg/1; mg/1; mg/1; mg/1 50332-0106_839b8158-f199-4dad-8efc-ab8cb9598047 50332-0106 HUMAN OTC DRUG NUTRALOX CALCIUM CARBONATE TABLET, CHEWABLE ORAL 19870120 OTC MONOGRAPH FINAL part331 HART Health CALCIUM CARBONATE 420 mg/1 50332-0108_be810cb9-d7f4-481a-808f-527c3a157b29 50332-0108 HUMAN OTC DRUG CETAFEN EXTRA acetaminophen TABLET ORAL 19900105 OTC MONOGRAPH NOT FINAL part343 HART Health ACETAMINOPHEN 500 mg/1 50332-0109_bf79ff33-0c19-4066-afe4-a14a118bb067 50332-0109 HUMAN OTC DRUG Proprinal ibuprofen TABLET, SUGAR COATED ORAL 19900601 OTC MONOGRAPH NOT FINAL part343 NorMed IBUPROFEN 200 mg/1 50332-0118_c390ecb3-4a05-452e-9a46-7852100ccffb 50332-0118 HUMAN OTC DRUG IBUPROFEN ibuprofen TABLET ORAL 19870603 OTC MONOGRAPH NOT FINAL part343 HART Health IBUPROFEN 200 mg/1 50332-0126_aff1a2e6-dfd0-48b3-ad03-f557602c58fd 50332-0126 HUMAN OTC DRUG Sudo-Tab PE phenylephrine hcl TABLET ORAL 20051003 OTC MONOGRAPH FINAL part341 HART Health PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 50332-0127_cdc37028-7070-4541-8d4a-52507e512a6b 50332-0127 HUMAN OTC DRUG Relief-PE ACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINE TABLET, COATED ORAL 20120416 OTC MONOGRAPH NOT FINAL part343 NorMed ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 50332-0132_799687e5-495e-4976-9c42-646e23168002 50332-0132 HUMAN OTC DRUG HISTAPRIN DIPHENHYDRAMINE TABLET ORAL 20090101 OTC MONOGRAPH FINAL part336 NorMed DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 50332-0201_10cfade6-b054-47a5-8044-78b9da174b1c 50332-0201 HUMAN OTC DRUG Eye Clean Eye Wash LIQUID OPHTHALMIC 19000101 OTC MONOGRAPH FINAL part349 HART Health WATER 98.3 mL/100mL 50332-0212_2dd9c749-a510-4b9e-acdf-0f34c5239ee9 50332-0212 HUMAN OTC DRUG First Aid Benzalkonium Chloride, Benzocaine SPRAY TOPICAL 19960206 OTC MONOGRAPH FINAL part333A HART Health BENZALKONIUM CHLORIDE; BENZOCAINE 1; 50 mg/1000mg; mg/1000mg 50346-001_f0a92676-2545-457f-80c3-d2e24b83653d 50346-001 HUMAN OTC DRUG Pure Petroleum White Petroleum JELLY TOPICAL 20120526 OTC MONOGRAPH FINAL part347 Pan Aromas LLC PETROLATUM 1 g/g 50346-002_2160c60b-093e-4042-9b7a-6568b5527b36 50346-002 HUMAN OTC DRUG Baby Fresh Scent Petroleum White Petroleum JELLY TOPICAL 20120526 OTC MONOGRAPH FINAL part347 Pan Aromas LLC PETROLATUM .99 g/g 50346-003_b1e5495f-9bdf-4264-9cd1-3d004d2f599f 50346-003 HUMAN OTC DRUG Pure Petroleum Cocoa Butter Scented White Petroleum JELLY TOPICAL 20120526 OTC MONOGRAPH FINAL part347 Pan Aromas LLC PETROLATUM .99 g/g 50346-004_e8f3c7ef-caed-42fc-bdc6-532544390ee8 50346-004 HUMAN OTC DRUG Pan Aromas Baby TALC POWDER TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part347 Pan Aromas LLC TALC 1 g/g 50346-005_a1ef7014-45b2-408e-8e99-952c0ffbcc27 50346-005 HUMAN OTC DRUG Pan Aromas Baby Mineral Oil OIL TOPICAL 20121220 OTC MONOGRAPH FINAL part347 Pan Aromas LLC MINERAL OIL 99.9 mL/100mL 50353-100_44f1506a-45ff-44e9-a016-014f5ecb740b 50353-100 HUMAN OTC DRUG Purmist CHLORHEXIDINE GLUCONATE, ETHYL ALCOHOL SOLUTION TOPICAL 20100601 OTC MONOGRAPH FINAL part333 MKR International Inc ALCOHOL; CHLORHEXIDINE GLUCONATE .7; .01 g/mL; g/mL 50353-101_23cadcaa-85ff-4e72-a3e2-88fde5ad51f1 50353-101 HUMAN OTC DRUG Purmist CHLORHEXIDINE GLUCONATE, ETHYL ALCOHOL SOLUTION TOPICAL 20100601 OTC MONOGRAPH FINAL part333 MKR International Inc ALCOHOL; CHLORHEXIDINE GLUCONATE .7; .01 g/mL; g/mL 50353-102_a7019078-4f92-487b-8104-2e7347befa97 50353-102 HUMAN OTC DRUG Purmist CHLORHEXIDINE GLUCONATE, ETHYL ALCOHOL SOLUTION TOPICAL 20100601 OTC MONOGRAPH FINAL part333 MKR International Inc ALCOHOL; CHLORHEXIDINE GLUCONATE .7; .01 g/mL; g/mL 50353-103_e0ff1b42-3823-43b0-a3e1-2c21b3fbf932 50353-103 HUMAN OTC DRUG Purmist CHLORHEXIDINE GLUCONATE, ETHYL ALCOHOL SOLUTION TOPICAL 20100601 OTC MONOGRAPH FINAL part333 MKR International Inc ALCOHOL; CHLORHEXIDINE GLUCONATE .7; .01 g/mL; g/mL 50367-100_d338e7ef-67ed-461f-ac55-9d9610c275e7 50367-100 HUMAN OTC DRUG FLUEndz Asafoetida, Astragalus Menziesii, Illicium Anisatum, Lonicera Zylosteum SPRAY ORAL 20100115 UNAPPROVED HOMEOPATHIC Herbology International LLC ASAFETIDA; ASTRAGALUS NUTTALLII LEAF; LONICERA XYLOSTEUM FRUIT; STAR ANISE 3; 6; 6; 1 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL 50375-2001_7490359b-f33e-4f4f-b0e5-1e2dc01fd312 50375-2001 HUMAN OTC DRUG Scal-tonic intensive liquid hair care panthenol LIQUID TOPICAL 20100301 UNAPPROVED DRUG OTHER Doori Cosmetics Co., Ltd MENTHOL; PANTHENOL; SALICYLIC ACID 300; 200; 250 mg/g; mg/g; mg/g 50375-3001_17f6b292-aac0-4f27-b42e-e300bfe801ee 50375-3001 HUMAN OTC DRUG Scal tonic shampoo hair care panthenol SHAMPOO TOPICAL 20100301 UNAPPROVED DRUG OTHER Doori Cosmetics Co., Ltd PANTHENOL .002 mL/mL 50375-4001_57ad69ad-d47e-43d2-acde-26462dc6f186 50375-4001 HUMAN OTC DRUG Intensive scalp care essence hair care panthenol LIQUID TOPICAL 20100301 UNAPPROVED DRUG OTHER Doori Cosmetics Co., Ltd PANTHENOL .002 mL/mL 50375-5001_aa3ecbe1-ed79-4719-b40a-ed5dda9ee476 50375-5001 HUMAN OTC DRUG Intensive Scal Care Shampoo hair care panthenol SHAMPOO TOPICAL 20100301 UNAPPROVED DRUG OTHER Doori Cosmetics Co., Ltd PANTHENOL .02 mL/mL 50382-002_43a17fc1-50a5-4be9-85d2-b0d7ed36be2b 50382-002 HUMAN OTC DRUG Saline Enema SALINE ENEMA ENEMA RECTAL 20130801 OTC MONOGRAPH NOT FINAL part334 Galentic Pharma (India) Priva Te Ltd. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 50382-003_ac08d733-4b4a-4721-b701-5c8444aafc8d 50382-003 HUMAN OTC DRUG Galentic Vitamin A D Petrolatum OINTMENT TOPICAL 20130806 OTC MONOGRAPH FINAL part347 Galentic Pharma (India) Priva Te Limited PETROLATUM .76 g/g 50382-004_64c54ba8-05dd-48a2-b8c3-c26d7f869233 50382-004 HUMAN OTC DRUG Antifungal Antifungal CREAM TOPICAL 20130807 OTC MONOGRAPH FINAL part333C Galentic Pharma (India) Priva Te Limited CLOTRIMAZOLE 1 g/100g 50382-005_2a35f493-11e4-49ab-bacd-3b1eede3d97a 50382-005 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20130802 OTC MONOGRAPH FINAL part333B Galentic Pharma (India) Priva Te Limited BACITRACIN 500 [iU]/g 50382-006_2df92cf8-0c9b-427a-bfa6-00026f64a322 50382-006 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20130806 OTC MONOGRAPH FINAL part333B Galentic Pharma (India) Priva Te Limited BACITRACIN ZINC 500 [iU]/g 50382-007_c9bb6350-4876-4aa2-8986-51dc17925315 50382-007 HUMAN OTC DRUG HYDROCORTISONE ACETATE Hydrocortisone Acetate OINTMENT TOPICAL 20110906 OTC MONOGRAPH NOT FINAL part348 Galentic Pharma (India) Private Limited HYDROCORTISONE ACETATE 1 g/100g 50382-008_cae22cb8-66e4-4702-80c2-89428b37f1cc 50382-008 HUMAN OTC DRUG bacitracin zinc, neomycin sulfate and polymyxin b sulfate bacitracin zinc, neomycin sulfate and polymyxin b sulfate OINTMENT TOPICAL 20130807 OTC MONOGRAPH FINAL part333B Galentic Pharma (India) Private Limited BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [iU]/g; mg/g; [iU]/g 50382-009_8b6f01c2-5a58-4818-b9f7-22bad9bddbd4 50382-009 HUMAN OTC DRUG Mineral Oil MINERAL OIL ENEMA RECTAL 20130807 OTC MONOGRAPH NOT FINAL part334 Galentic Pharma (India) Priva Te Limited MINERAL OIL 118 g/118mL 50382-010_a66e7c0f-e3f8-4b5d-8e07-4522c86b6c38 50382-010 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part348 Galentic Pharma (India) Priva Te Limited HYDROCORTISONE ACETATE 1 g/100g 50382-011_646352db-de91-4a3f-9681-ec47226fa11a 50382-011 HUMAN OTC DRUG zinc oxide zinc oxide OINTMENT TOPICAL 20130808 OTC MONOGRAPH FINAL part347 Galentic Pharma (India) Private Limited ZINC OXIDE 1.8 g/100g 50382-012_c824ad2f-391a-464f-a444-7b7d43d75038 50382-012 HUMAN OTC DRUG Zinc Oxide and Dimethicone with Dimethicone Zinc Oxide and Dimethicone CREAM TOPICAL 20130808 OTC MONOGRAPH FINAL part347 Galentic Pharma (India) Private Limited DIMETHICONE; ZINC OXIDE 18; 200 mg/g; mg/g 50382-013_ce3508ad-18b4-4ddc-8d7f-538484aab8d1 50382-013 HUMAN OTC DRUG Galentic Hydrogel glycerin GEL TOPICAL 20140414 OTC MONOGRAPH FINAL part346 Galentic Pharma (India) Private Limited GLYCERIN 20 g/100g 50382-050_3484819a-ee23-4388-bafa-c3ee839ddae8 50382-050 HUMAN OTC DRUG MICONAZOLE antifungal CREAM TOPICAL 20130718 OTC MONOGRAPH FINAL part333C Galentic Pharma (India) Priva Te Limited MICONAZOLE NITRATE 20 mg/g 50382-051_e1464e9e-9350-4572-ba59-c4c26535fec3 50382-051 HUMAN OTC DRUG Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20130719 OTC MONOGRAPH FINAL part347 Galentic Pharma (India) Priva Te Limited ZINC OXIDE 200 mg/g 50383-001_66f23218-3c1e-443a-b0f0-af552f249ed0 50383-001 HUMAN OTC DRUG Minoxidil Minoxidil SOLUTION TOPICAL 19961224 ANDA ANDA074731 Hi-Tech Pharmacal Co., Inc. MINOXIDIL 2 g/100mL 50383-001_d5595f80-3f73-4f16-a701-1e4276b68b5e 50383-001 HUMAN OTC DRUG Minoxidil Minoxidil SOLUTION TOPICAL 19961224 ANDA ANDA074731 Hi-Tech Pharmacal Co., Inc. MINOXIDIL 2 g/100mL 50383-018_39eb84cd-6655-4d8a-b952-6f823f3b5473 50383-018 HUMAN OTC DRUG Eye Wash Eye Wash SOLUTION/ DROPS INTRAOCULAR 19970106 OTC MONOGRAPH FINAL part349 Hi-Tech Pharmacal Co., Inc. WATER 980 mg/mL 50383-021_a782a309-ee0f-4ed5-af4b-37238446e990 50383-021 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20020910 ANDA ANDA075163 Hi-Tech Pharmacal Co., Inc. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50383-024_0095d1d6-d83e-4e22-aa61-3b4753f0753b 50383-024 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20040514 ANDA ANDA076615 Hi-Tech Pharmacal Co., Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 50383-025_10d0fd2b-81f4-4836-b279-cf2b17813eb5 50383-025 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxaxin SOLUTION/ DROPS AURICULAR (OTIC) 20080317 ANDA ANDA076616 Hi-Tech Pharmacal Co., Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 50383-040_22a0e727-942c-49d9-a200-40183dfef804 50383-040 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20030326 ANDA ANDA075183 Hi-Tech Pharmacal Co., Inc. PREDNISOLONE SODIUM PHOSPHATE 5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50383-042_67542ba5-0bb2-41a1-bff1-74b4ddb17670 50383-042 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 20030227 ANDA ANDA040401 Hi-Tech Pharmacal Co., Inc. PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50383-043_714c12dc-c782-4f01-9fec-4d09bf413f1d 50383-043 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide SYRUP ORAL 20080208 ANDA ANDA040613 Hi-Tech Pharmacal Co., Inc. HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5; 5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50383-050_f2ec923a-2b88-43c0-ac2a-7ae20c053039 50383-050 HUMAN PRESCRIPTION DRUG Cimetidine Hydrochloride Oral Solution Cimetidine Hydrochloride Oral Solution SOLUTION ORAL 19971028 ANDA ANDA074664 Hi-Tech Pharmacal Co., Inc. CIMETIDINE HYDROCHLORIDE 300 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 50383-051_7a316ed8-68a7-43fa-a247-b72609893a76 50383-051 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SOLUTION ORAL 20110322 ANDA ANDA091078 Hi-Tech Pharmacal Co., Inc. RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 50383-062_eda4db26-e020-4ca8-a63f-590484a06824 50383-062 HUMAN OTC DRUG Dextromethorphan HBr and Guaifenesin Dextromethorphan HBr and Guaifenesin SOLUTION ORAL 20120307 OTC MONOGRAPH FINAL part341 Hi-Tech Pharmacal Co., Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 50383-063_4d939198-a09c-46b0-a8fe-fc2b09b5177d 50383-063 HUMAN OTC DRUG Guaifenesin Guaifenesin SOLUTION ORAL 20120307 OTC MONOGRAPH FINAL part341 Hi-Tech Pharmacal Co., Inc. GUAIFENESIN 100 mg/5mL 50383-079_473eab7f-2a28-4583-9563-6a7dc4ce936a 50383-079 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 19960426 ANDA ANDA040119 Hi-Tech Pharmacal Co., Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 50383-087_a3f9be67-29e5-4038-bfc4-150d3a339199 50383-087 HUMAN OTC DRUG Guaiatussin AC guaifenesin and codeine phosphate LIQUID ORAL 20100908 OTC MONOGRAPH FINAL part341 Hi-Tech Pharmacal Co., Inc. CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 50383-171_3563c2f5-9814-4d55-8d90-bd7d6dcff36b 50383-171 HUMAN PRESCRIPTION DRUG Levocarnitine Levocarnitine SOLUTION ORAL 20071025 ANDA ANDA077399 Hi-Tech Pharmacal Co., Inc. LEVOCARNITINE 1 g/10mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] 50383-172_c8a590a7-628b-45c5-ac2c-24214a69eaa6 50383-172 HUMAN PRESCRIPTION DRUG Levocarnitine Levocarnitine TABLET ORAL 20051101 NDA NDA018948 Hi-Tech Pharmacal Co., Inc. LEVOCARNITINE 330 mg/1 Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] 50383-189_3b49883f-27c7-4d28-adf9-5149969e7c80 50383-189 HUMAN PRESCRIPTION DRUG Gatifloxacin Gatifloxacin SOLUTION/ DROPS OPHTHALMIC 20141006 ANDA ANDA203189 Hi-Tech Pharmacal Co., Inc. GATIFLOXACIN ANHYDROUS 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 50383-232_3f481fd2-2aa2-4b17-a27e-5093f9c54b8c 50383-232 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride Dorzolamide Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20081028 ANDA ANDA077846 Hi-Tech Pharmacal Co., Inc. DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] 50383-233_05939156-72cb-4c62-b7e8-728d1270a31f 50383-233 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride and Timolol Maleate Dorzolamide Hydrochloride and Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20081028 ANDA ANDA077847 Hi-Tech Pharmacal Co., Inc. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50383-241_f3f3aefe-c210-4c16-8c5c-1f810d938f92 50383-241 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam SOLUTION ORAL 20120228 ANDA ANDA090601 Hi-Tech Pharmacal Co., Inc. LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50383-249_3f300766-1a87-4241-aa89-fb5ee5864248 50383-249 HUMAN PRESCRIPTION DRUG bromfenac bromfenac SOLUTION/ DROPS OPHTHALMIC 20140122 ANDA ANDA203395 Hi-Tech Pharmacal Co., Inc. BROMFENAC SODIUM 1.035 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50383-266_4fc7e152-1d4e-489d-bd00-0b00338b8eba 50383-266 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate SOLUTION TOPICAL 20100607 ANDA ANDA074222 Hi-Tech Pharmacal Co., Inc. CLOBETASOL PROPIONATE .4625 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50383-267_9153a74e-b768-4fc6-866b-c5eb8dabb612 50383-267 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 20100607 ANDA ANDA074220 Hi-Tech Pharmacal Co., Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50383-268_9153a74e-b768-4fc6-866b-c5eb8dabb612 50383-268 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate OINTMENT TOPICAL 20100607 ANDA ANDA074221 Hi-Tech Pharmacal Co., Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50383-269_c2fe3323-7cfd-47b2-9695-ac39ae559f44 50383-269 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate GEL TOPICAL 20100607 ANDA ANDA076141 Hi-Tech Pharmacal Co., Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50383-270_833fb607-f9df-491e-bf67-33370ff7a746 50383-270 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate EMULSION TOPICAL 20100607 ANDA ANDA075325 Hi-Tech Pharmacal Co., Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50383-282_a2d36cea-f8be-40c5-97ab-deec91fa885c 50383-282 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20050121 ANDA ANDA076673 Hi-Tech Pharmacal Co., Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 50383-283_1272557e-0530-4164-8579-7927b0ec1de7 50383-283 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin SOLUTION/ DROPS OPHTHALMIC 20110210 ANDA ANDA076826 Hi-Tech Pharmacal Co., Inc. LEVOFLOXACIN 5 mg/mL 50383-286_261fc07c-b921-482a-8231-4543c6cf9f2b 50383-286 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin SOLUTION ORAL 20110621 ANDA ANDA091678 Hi-Tech Pharmacal Co., Inc. LEVOFLOXACIN 25 mg/mL 50383-311_0d2b4d3d-912c-42b7-99c8-22aa8e81249a 50383-311 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin SOLUTION ORAL 20110223 ANDA ANDA078974 Hi-Tech Pharmacal Co., Inc. GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50383-419_c6496f76-af80-472f-900a-1eef25de4e2f 50383-419 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SOLUTION TOPICAL 20070918 ANDA ANDA078270 Hi-Tech Pharmacal Co., Inc. CICLOPIROX 71.3 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 50383-565_669f3f31-bb8c-4279-a368-8cbd32eff9bb 50383-565 HUMAN PRESCRIPTION DRUG Neomycin Sulfate Neomycin Sulfate TABLET ORAL 20100312 ANDA ANDA065220 HI TECH PHARMACAL CO INC NEOMYCIN SULFATE 500 mg/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 50383-587_0d649357-80be-426c-87b3-696675bd7478 50383-587 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20120127 ANDA ANDA064042 Hi-Tech Pharmacal Co., Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 50383-618_12bef5ba-d5d3-4b19-8a22-6f2c542ebd76 50383-618 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride SOLUTION ORAL 19951117 ANDA ANDA074352 Hi-Tech Pharmacal Co., Inc. LOPERAMIDE HYDROCHLORIDE 1 mg/5mL 50383-667_390ccf7a-2bf5-4ba0-9bc4-d0293520e05b 50383-667 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine Lidocaine and Prilocaine CREAM TOPICAL 20030925 ANDA ANDA076290 Hi-Tech Pharmacal Co., Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 50383-700_52453ecd-e2a0-4efe-ad4f-e71babebcc8d 50383-700 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20080116 ANDA ANDA077570 Hi-Tech Pharmacal Co., Inc. FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50383-705_578117c5-631a-4d90-917b-48197b533a2f 50383-705 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam CONCENTRATE ORAL 20120130 ANDA ANDA200169 Hi-Tech Pharmacal Co., Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50383-720_068122c5-ec0b-472b-8425-c54be20e42ec 50383-720 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 19960507 ANDA ANDA074356 Hi-Tech Pharmacal Co., Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] 50383-740_e620211f-f462-4e20-a3c7-61a38c9cae38 50383-740 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP ORAL 19980130 ANDA ANDA074749 Hi-Tech Pharmacal Co., Inc. ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 50383-741_c1269c5e-b23d-4576-8d33-76636a3dc025 50383-741 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19980115 ANDA ANDA074543 Hi-Tech Pharmacal Co., Inc. ALBUTEROL SULFATE 5 mg/mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 50383-771_54865ec1-0308-4717-a6a0-3536d84d7bc2 50383-771 HUMAN OTC DRUG Docu Docusate Sodium LIQUID ORAL 19970801 OTC MONOGRAPH NOT FINAL part334 Hi-Tech Pharmacal Co., Inc. DOCUSATE SODIUM 50 mg/5mL 50383-772_319b6093-ed21-4526-b6ed-a9470430ca47 50383-772 HUMAN PRESCRIPTION DRUG Anestacon Lidocaine hydrochloride JELLY TOPICAL 20011105 ANDA ANDA080429 Hi-Tech Pharmacal Co., Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 50383-775_aab83f5f-8ec1-4868-b1a9-8bf5041e57e4 50383-775 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19950710 ANDA ANDA040014 Hi-Tech Pharmacal Co., Inc. LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 50383-779_c3b21753-316e-4a50-b869-77aa4b6d1d16 50383-779 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL 19950703 ANDA ANDA074076 Hi-Tech Pharmacal Co., Inc. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 50383-781_dcadad76-691a-477d-ac38-fc749419396c 50383-781 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 20110323 ANDA ANDA040837 Hi-Tech Pharmacal Co., Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 50383-792_58134b5f-f942-4c43-becc-b50f520602eb 50383-792 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid SOLUTION ORAL 19950113 ANDA ANDA074060 Hi-Tech Pharmacal Co., Inc. VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 50383-795_166675b2-2f92-4636-854a-c161e30d4c2d 50383-795 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL; RECTAL 19950703 ANDA ANDA074077 Hi-Tech Pharmacal Co., Inc. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 50383-796_6a665766-1898-4610-ae98-4a5db259c0dc 50383-796 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride HydrOXYzine Hydrochloride SOLUTION ORAL 19941028 ANDA ANDA040010 Hi-Tech Pharmacal Co., Inc HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 50383-801_fc6fffec-7be1-415c-8b5a-8748db9a2612 50383-801 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SOLUTION ORAL 19980925 ANDA ANDA040026 Hi-Tech Pharmacal Co., Inc. PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 50383-803_c9a1212e-479a-4981-bf22-94e89825321d 50383-803 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextromethorphan Hydrobromide Promethazine Hydrochloride and Dextromethorphan Hydrobromide SOLUTION ORAL 19960731 ANDA ANDA040027 Hi-Tech Pharmacal Co., Inc. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] 50383-804_e299ff5a-6e48-4c82-ac99-04f683bb5ed2 50383-804 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Codeine Phosphate Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 19970826 ANDA ANDA040151 Hi-Tech Pharmacal Co., Inc. CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 50383-807_b2b749a8-b14f-423a-94be-a72033a32f73 50383-807 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride SOLUTION ORAL 19941028 ANDA ANDA074170 Hi-Tech Pharmacal Co., Inc. AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 50383-810_449d2a92-17d6-46a8-90dd-bfaa2463f071 50383-810 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir SUSPENSION ORAL 20050607 ANDA ANDA077026 Hi-Tech Pharmacal Co., Inc. ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 50383-823_bb1be3c3-f269-4680-87d3-021b3fdb27e2 50383-823 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 19971229 ANDA ANDA074650 Hi-Tech Pharmacal Co., Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 50383-824_bb1be3c3-f269-4680-87d3-021b3fdb27e2 50383-824 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 19971229 ANDA ANDA074650 Hi-Tech Pharmacal Co., Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 50383-855_939131a9-f0e7-48c0-b5a7-d4bcde729751 50383-855 HUMAN PRESCRIPTION DRUG Paregoric Paregoric LIQUID ORAL 20120806 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Hi-Tech Pharmacal Co., Inc. MORPHINE 2 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 50383-889_7699a50c-6c48-4d05-b950-113b690b0ee2 50383-889 HUMAN PRESCRIPTION DRUG acetic acid acetic acid SOLUTION AURICULAR (OTIC) 20100122 NDA NDA012179 Hi-Tech Pharmacal Co., Inc. ACETIC ACID 20.65 mg/mL 50383-901_d21f6fff-111d-4222-a996-b3bfd0f3d6ee 50383-901 HUMAN PRESCRIPTION DRUG Hydrocortisone and Acetic Acid Hydrocortisone and Acetic Acid SOLUTION AURICULAR (OTIC) 20090604 NDA NDA012770 Hi-Tech Pharmacal Co., Inc. ACETIC ACID; HYDROCORTISONE 20.75; 10.375 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50383-924_94751676-f625-4673-b2cc-08bb5044137c 50383-924 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20100924 ANDA ANDA090622 Hi-Tech Pharmacal Co., Inc. BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 50383-930_94751676-f625-4673-b2cc-08bb5044137c 50383-930 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20100924 ANDA ANDA090622 Hi-Tech Pharmacal Co., Inc. BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 50383-933_c7583b35-3dbf-465d-8909-a16206a352bc 50383-933 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20120312 ANDA ANDA040911 Hi-Tech Pharmacal Co., Inc. LIDOCAINE 5 g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 50383-959_9a773f26-2d86-4b5e-abfa-ef5718c8184b 50383-959 HUMAN PRESCRIPTION DRUG Protriptyline hydrochloride Protriptyline hydrochloride TABLET, FILM COATED ORAL 20131028 ANDA ANDA202220 Hi-Tech Pharmacal Co., Inc. PROTRIPTYLINE HYDROCHLORIDE 5 mg/1 Tricyclic Antidepressant [EPC] 50383-960_9a773f26-2d86-4b5e-abfa-ef5718c8184b 50383-960 HUMAN PRESCRIPTION DRUG Protriptyline hydrochloride Protriptyline hydrochloride TABLET, FILM COATED ORAL 20131028 ANDA ANDA202220 Hi-Tech Pharmacal Co., Inc. PROTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 50387-100_bbcf9449-9ed4-43c9-877f-59aa7901e1c8 50387-100 HUMAN OTC DRUG Forest Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 E-House Korea Holdings International STARCH, CORN 3.16 g/4g 50387-100_db1381c4-9d07-4daa-9846-ebd3adaefb35 50387-100 HUMAN OTC DRUG Forest Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 E-House Korea Holdings International STARCH, CORN 3.16 g/4g 50387-200_19bf408e-ddaa-4b11-8ae7-bc45ce26a846 50387-200 HUMAN OTC DRUG Warm Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 E-House Korea Holdings International STARCH, CORN 3.16 g/4g 50387-200_cd5cff0a-ecaa-42a5-8a50-a1fafbf610a6 50387-200 HUMAN OTC DRUG Warm Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 E-House Korea Holdings International STARCH, CORN 3.16 g/4g 50387-300_19ca3cbb-95e1-4565-975b-3014969fd671 50387-300 HUMAN OTC DRUG BBCREAM TITANIUM DIOXIDE, ETHYLHEXYL METHOXYCINNAMATE CREAM TOPICAL 20110420 OTC MONOGRAPH FINAL part352 E-House Korea Holdings International OCTINOXATE; TITANIUM DIOXIDE 1.35; 3.04 mL/30mL; mL/30mL 50390-000_3024fdf8-4958-4df2-83e2-0b86b5fb22dd 50390-000 HUMAN OTC DRUG SATINIQUE ANTI-DANDRUFF for dry, irritated scalp PYRITHIONE ZINC SHAMPOO TOPICAL 20140213 OTC MONOGRAPH FINAL part358H Amway Corp PYRITHIONE ZINC 9.5 mg/mL 50390-108_8c203a2e-f319-488a-8dff-8a983706fbad 50390-108 HUMAN OTC DRUG ARTISTRY IDEAL RADIANCE UV Protect SPF 50 PLUS Broad Spectrum Sunscreen OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part352 Amway Corp OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 68; 45; 24.9; 126.6 mg/mL; mg/mL; mg/mL; mg/mL 50390-109_c2e64838-f005-4343-b38f-06adbbf2b158 50390-109 HUMAN OTC DRUG ARTISTRY Time Defiance UV Defense SPF 50 Ultra Facial Sunscreen OCTINOXATE, ZINC OXIDE, OCTISALATE,TITANIUM DIOXIDE CREAM TOPICAL 20130726 OTC MONOGRAPH NOT FINAL part352 Amway Corp OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 45; 24.9; 125 mg/mL; mg/mL; mg/mL; mg/mL 50390-110_eee8d16c-45bd-40a1-b3ec-f3a5dc3e2131 50390-110 HUMAN OTC DRUG ARTISTRY Time Defiance UV Defense SPF 50 Ultra Facial Sunscreen OCTINOXATE, ZINC OXIDE, OCTISALATE,TITANIUM DIOXIDE CREAM TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Amway Corp OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 2.49; 6.528 mL/100mL; mL/100mL; mL/100mL; mL/100mL 50390-111_02fdf286-01ab-40df-8c9c-d054d0fe74c8 50390-111 HUMAN OTC DRUG ARTISTRY YOUTH XTEND Lifting Smoothing Foundation Broad Spectrum SPF 20 Sunscreen OCTINOXATE, OXYBENZONE CREAM TOPICAL 20130506 OTC MONOGRAPH NOT FINAL part352 Amway Corp OCTINOXATE; OXYBENZONE 75; 10 mg/mL; mg/mL 50390-112_0fd4f3d5-9466-4f0c-8249-5acd0be48896 50390-112 HUMAN OTC DRUG ARTISTRY YOUTH XTEND Protecting Broad Spectrum SPF 15 Sunscreen OCTINOXATE,AVOBENZONE,OXYBENZONE CREAM TOPICAL 20130506 OTC MONOGRAPH NOT FINAL part352 Amway Corp AVOBENZONE; OCTINOXATE; OXYBENZONE 3; 7.5; 1 g/100g; g/100g; g/100g 50390-113_db45ebfe-a6d2-468c-8352-c69dc36b27dd 50390-113 HUMAN OTC DRUG ARTISTRY YOUTH XTEND Protecting Broad Spectrum SPF 15 OCTINOXATE,AVOBENZONE,OXYBENZONE LOTION TOPICAL 20130506 OTC MONOGRAPH NOT FINAL part352 Amway Corp AVOBENZONE; OCTINOXATE; OXYBENZONE 30; 75; 10 mg/mL; mg/mL; mg/mL 50390-701_12838bda-3b39-4415-a956-cff0532dda35 50390-701 HUMAN OTC DRUG Peter Island Continuous Sport Sunscreen SPF 50 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE SPRAY TOPICAL 20121126 OTC MONOGRAPH NOT FINAL part352 AMWAY CORP. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2; 6 g/100g; g/100g; g/100g; g/100g; g/100g 50390-702_d42740ea-1ae3-4a4c-a0b3-a780f5a59c96 50390-702 HUMAN OTC DRUG Peter Island Sunscreen SPF 50 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20121126 OTC MONOGRAPH NOT FINAL part352 AMWAY CORP. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 50390-703_7519d11b-d59f-483a-a242-b38dea2f5b35 50390-703 HUMAN OTC DRUG Peter Island Kids Sunscreen SPF 65 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20121126 OTC MONOGRAPH NOT FINAL part352 AMWAY CORP. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g 50390-704_97e0b336-4a3f-44e1-8fef-69bf4ad865fd 50390-704 HUMAN OTC DRUG Peter Island Sunscreen SPF 70 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20121126 OTC MONOGRAPH NOT FINAL part352 AMWAY CORP. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g 50390-705_d6626f99-360b-407c-ad4a-c9a9f9258e3c 50390-705 HUMAN OTC DRUG Peter Island Sunscreen SPF 30 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20121126 OTC MONOGRAPH NOT FINAL part352 AMWAY CORP. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g 50390-706_710ba90e-e8ac-498d-8971-3f6777f9c094 50390-706 HUMAN OTC DRUG Peter Island Baby Sunscreen SPF 50 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20121126 OTC MONOGRAPH NOT FINAL part352 AMWAY CORP. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 50390-707_1426a253-7c87-489d-95da-1e078f3c9fab 50390-707 HUMAN OTC DRUG Peter Island Ultimate Sheer Dry Touch Sunscreen SPF 70 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20121126 OTC MONOGRAPH NOT FINAL part352 AMWAY CORP. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2.8; 6 g/100g; g/100g; g/100g; g/100g; g/100g 50390-708_332591b4-59ee-4ca1-8451-583b5f02c7df 50390-708 HUMAN OTC DRUG PETER ISLAND Continuous Sunscreen Sport 50 BROAD SPECTRUM SPF 50 Water Resistant AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20130514 OTC MONOGRAPH NOT FINAL part352 Amway Corp. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 30; 100; 50 mg/mL; mg/mL; mg/mL 50390-709_6bbadb39-a884-49d2-bf73-903b21ab51d5 50390-709 HUMAN OTC DRUG PETER ISLAND NATURAL MINERAL SUNCREEN BROAD SPECTRUM SPF 60 Water Resistant TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20130514 OTC MONOGRAPH NOT FINAL part352 Amway Corp TITANIUM DIOXIDE; ZINC OXIDE 28; 40 mg/mL; mg/mL 50390-710_08f8985f-774c-4e8d-98e9-95e4d9e3feda 50390-710 HUMAN OTC DRUG PETER ISLAND Continuous Sunscreen KIDS 50 BROAD SPECTRUM SPF 50 Water Resistant AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20130514 OTC MONOGRAPH NOT FINAL part352 Amway Corp. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 30; 100; 50 mg/mL; mg/mL; mg/mL 50402-100_243d0321-266d-4f8c-a8f4-2c311eb839d1 50402-100 HUMAN PRESCRIPTION DRUG IDkit HP ONE citric acid anhydrous and 13C urea KIT ORAL 20091228 NDA NDA021314 Exalenz Bioscience Ltd. 50403-050_c64d5251-a899-4b64-9d6d-d0d285bbe92e 50403-050 HUMAN OTC DRUG IQQU Advanced Sunscreen SPF 50 Octyl Methoxycinnamate and Simmondsia Chinensis Seed Oil and Titanium Dioxide and Tocopheryl Acetate LOTION TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 IQQU USA Co. .ALPHA.-TOCOPHEROL ACETATE, D-; JOJOBA OIL; LYCOPENE; OCTINOXATE; SACCHARIDE ISOMERATE; TITANIUM DIOXIDE .3; 1.5; .3; .9; .3; .9 g/.01g; g/.05g; g/.01g; g/.03g; g/.01g; g/.03g 50403-226_ecd5a40f-07db-4814-b08b-710f3a85f10f 50403-226 HUMAN OTC DRUG IQQU Acne Serum Acne Serum LOTION TOPICAL 20090801 UNAPPROVED DRUG OTHER IQQU USA Co. CARNITINE; LECITHIN, SOYBEAN; UBIDECARENONE .012; .024; .0012 g/g; g/30g; g/g 50403-999_2083b860-64a8-4ea5-b56f-5af21f82bb2a 50403-999 HUMAN OTC DRUG IQQU Advance Sunscreen Dimethicone and Butyl Methoxydibenzoylmethane and Titanium Dioxide and Octyl Methoxycinnamate LOTION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 IQQU USA Co. AVOBENZONE; DIMETHICONE; OCTINOXATE; TITANIUM DIOXIDE 22; 25; 50; 40 g/mL; g/mL; g/mL; g/mL 50405-001_7b0792e4-a4bd-471d-a1b9-6ab737af51f3 50405-001 HUMAN OTC DRUG SohMed Extra Strength Acetaminophen TABLET ORAL 20130825 OTC MONOGRAPH NOT FINAL part343 SOHM Inc. ACETAMINOPHEN 500 mg/1 50405-002_db5fbd25-f7dd-4a7e-8244-4b416e68dede 50405-002 HUMAN OTC DRUG SohMed Acid Reducer ALUMINUM HYDROXIDE and MAGNESIUM CARBONATE TABLET, CHEWABLE ORAL 20130825 OTC MONOGRAPH FINAL part331 SOHM Inc. ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 50405-003_fc1abe03-01c3-4256-88cc-8f12081ce662 50405-003 HUMAN OTC DRUG SohMed Allergy Sinus Acetaminophen, Chlorpheniramine maleate, and Phenylephrine HCl TABLET ORAL 20130825 OTC MONOGRAPH FINAL part341 SOHM Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 50405-004_47dc0428-8164-4ef3-97d4-47e6237dd824 50405-004 HUMAN OTC DRUG SohMed Allergy Diphenhydramine Hydrochloride TABLET ORAL 20130825 OTC MONOGRAPH FINAL part341 SOHM Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 50405-005_80ebd529-8309-4e99-aad8-11ea709ca5f7 50405-005 HUMAN OTC DRUG SohMed Alertness Aid Caffeine TABLET ORAL 20130825 OTC MONOGRAPH FINAL part340 SOHM Inc. CAFFEINE 200 mg/1 50405-006_4173790e-f178-44a6-a5fd-0301465ac08f 50405-006 HUMAN OTC DRUG SohMed Cold Relief Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20130825 OTC MONOGRAPH FINAL part341 SOHM Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 50405-007_e8334d2f-c39d-46e5-adf6-74ec49c0c2fa 50405-007 HUMAN OTC DRUG SohMed Pain Relief PM Acetaminophen and Diphenhydramine Hydrochloride TABLET ORAL 20130825 OTC MONOGRAPH NOT FINAL part343 SOHM Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 50405-008_53f2e6c3-b328-4867-a442-3bc74cfaf799 50405-008 HUMAN OTC DRUG SohMed Pain Reliever Acetaminophen, Aspirin, and Caffeine TABLET ORAL 20130825 OTC MONOGRAPH NOT FINAL part343 SOHM Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 50405-009_13d67cad-bab8-4bae-bbe9-d3e4a14bd501 50405-009 HUMAN OTC DRUG SohMed Sinus Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20130825 OTC MONOGRAPH FINAL part341 Sohm Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 50405-110_3c64e61b-aa7c-4978-8def-10647713dae3 50405-110 HUMAN OTC DRUG Salic-2 Salicylic Acid GEL TOPICAL 20131115 OTC MONOGRAPH FINAL part333D SOHM Inc. SALICYLIC ACID 1.2 g/60g 50409-514_86f6b0d9-e0f9-4042-9e9c-62607f7679c6 50409-514 HUMAN OTC DRUG Native Green Foaming Hand Sanitizer benzalkonium chloride SOLUTION TOPICAL 20100421 OTC MONOGRAPH NOT FINAL part333 Native Green BENZALKONIUM CHLORIDE 1 g/1000mL 50410-010_8ebf53d8-d29b-46ce-a142-6f94cfffc3db 50410-010 HUMAN OTC DRUG Belucie Luxury Essential Twin Pact NO21 SPF25 PA PLUS PLUS Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20120301 OTC MONOGRAPH FINAL part352 KIMJEONGMOON ALOE CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .48; .744; .235 g/12g; g/12g; g/12g 50410-020_f404b40e-6ba1-47d7-a0d0-179c21d11c35 50410-020 HUMAN OTC DRUG Belucie Luxury Essential Twin Pact NO23 SPF25 PA PLUS PLUS Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20120301 OTC MONOGRAPH FINAL part352 KIMJEONGMOON ALOE CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .48; .744; .235 g/12g; g/12g; g/12g 50410-030_f0420d22-97a6-4ad2-8e95-e9fa1ec0d74b 50410-030 HUMAN OTC DRUG Belucie Luxury Essential foundation BB ANTI WRINKLE SPF20 PA PLUS PLUS Titanium Dioxide CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part352 KIMJEONGMOON ALOE CO., LTD. TITANIUM DIOXIDE 3.25 g/35mL 50410-040_b7676b00-faaf-41c5-bf78-ebe22d79a552 50410-040 HUMAN OTC DRUG Belucie Luxury Timeless Golden Age Emulsion Dimethicone CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part347 KIMJEONGMOON ALOE CO., LTD. DIMETHICONE 2.93 g/125mL 50410-050_dd2997d9-df75-4445-9122-a9f5b864c317 50410-050 HUMAN OTC DRUG Belucie Luxury Timeless Golden Age Eye Dimethicone CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part347 KIMJEONGMOON ALOE CO., LTD. DIMETHICONE 1.5 g/30mL 50410-060_eb6747f2-2ecb-4a82-ae42-38ef221cfe29 50410-060 HUMAN OTC DRUG Belucie Luxury Timeless Golden Age Day Dimethicone CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part347 KIMJEONGMOON ALOE CO., LTD. DIMETHICONE .5 g/50mL 50410-070_383f5b74-e7c8-487f-9bbc-5e04f9b0694c 50410-070 HUMAN OTC DRUG Belucie Luxury Timeless Golden Age Night Dimethicone CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part347 KIMJEONGMOON ALOE CO., LTD. DIMETHICONE .5 g/50mL 50414-100_ac63737f-53f9-4668-8921-78f25a44f20b 50414-100 HUMAN OTC DRUG Hand Gel Prolim Instant Hand Sanitizer Alcohol GEL TOPICAL 20100310 OTC MONOGRAPH NOT FINAL part333 Prolim Quimica Avancada Ltda. ALCOHOL .7 mg/mL 50419-105_c499733a-f797-4963-8d26-a59673ca1951 50419-105 HUMAN PRESCRIPTION DRUG Betapace Sotalol Hydrochloride TABLET ORAL 19921030 NDA NDA019865 Bayer HealthCare Pharmaceuticals Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 50419-106_c499733a-f797-4963-8d26-a59673ca1951 50419-106 HUMAN PRESCRIPTION DRUG Betapace Sotalol Hydrochloride TABLET ORAL 19921030 NDA NDA019865 Bayer HealthCare Pharmaceuticals Inc. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC] 50419-109_c499733a-f797-4963-8d26-a59673ca1951 50419-109 HUMAN PRESCRIPTION DRUG Betapace Sotalol Hydrochloride TABLET ORAL 19921030 NDA NDA019865 Bayer HealthCare Pharmaceuticals Inc. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC] 50419-115_5c4d8fc9-89c5-4f5c-b78a-168fd34b64c6 50419-115 HUMAN PRESCRIPTION DRUG Betapace AF sotalol hydrochloride TABLET ORAL 20000222 NDA NDA021151 Bayer HealthCare Pharmaceuticals Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 50419-116_5c4d8fc9-89c5-4f5c-b78a-168fd34b64c6 50419-116 HUMAN PRESCRIPTION DRUG Betapace AF sotalol hydrochloride TABLET ORAL 20000222 NDA NDA021151 Bayer HealthCare Pharmaceuticals Inc. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC] 50419-119_5c4d8fc9-89c5-4f5c-b78a-168fd34b64c6 50419-119 HUMAN PRESCRIPTION DRUG Betapace AF sotalol hydrochloride TABLET ORAL 20000222 NDA NDA021151 Bayer HealthCare Pharmaceuticals Inc. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC] 50419-171_5cd5dab9-3fa6-44f7-a708-f6367eea482c 50419-171 HUMAN PRESCRIPTION DRUG Stivarga regorafenib TABLET, FILM COATED ORAL 20120927 NDA NDA203085 Bayer HealthCare Pharmaceuticals Inc. REGORAFENIB MONOHYDRATE 40 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 50419-188_640b8995-8945-4f87-b40d-733786fdc88e 50419-188 HUMAN PRESCRIPTION DRUG Magnevist gadopentetate dimeglumine INJECTION INTRAVENOUS 20101214 NDA NDA021037 Bayer HealthCare Pharmaceuticals Inc. GADOPENTETATE DIMEGLUMINE 469.01 mg/mL 50419-188_83fd9f82-64a8-404e-a65c-75ebb883abf8 50419-188 HUMAN PRESCRIPTION DRUG Magnevist Gadopentetate dimeglumine INJECTION INTRAVENOUS 20140611 NDA NDA019596 Bayer HealthCare Pharmaceuticals Inc. GADOPENTETATE DIMEGLUMINE 469.01 mg/mL 50419-208_a398400e-bd31-41a9-9696-4f7c06569ede 50419-208 HUMAN PRESCRIPTION DRUG Xofigo Radium Ra 223 dichloride INJECTION INTRAVENOUS 20130520 NDA NDA203971 Bayer HealthCare Pharmaceuticals Inc. RADIUM CHLORIDE RA-223 27 uCi/mL 50419-250_97c5f96e-69fd-4943-9f54-e31410e45636 50419-250 HUMAN PRESCRIPTION DRUG Adempas riociguat TABLET, FILM COATED ORAL 20131008 NDA NDA204819 Bayer HealthCare Pharmaceuticals Inc. RIOCIGUAT .5 mg/1 Guanylate Cyclase Stimulators [MoA],Soluble Guanylate Cyclase Stimulator [EPC] 50419-251_97c5f96e-69fd-4943-9f54-e31410e45636 50419-251 HUMAN PRESCRIPTION DRUG Adempas riociguat TABLET, FILM COATED ORAL 20131008 NDA NDA204819 Bayer HealthCare Pharmaceuticals Inc. RIOCIGUAT 1 mg/1 Guanylate Cyclase Stimulators [MoA],Soluble Guanylate Cyclase Stimulator [EPC] 50419-252_97c5f96e-69fd-4943-9f54-e31410e45636 50419-252 HUMAN PRESCRIPTION DRUG Adempas riociguat TABLET, FILM COATED ORAL 20131008 NDA NDA204819 Bayer HealthCare Pharmaceuticals Inc. RIOCIGUAT 1.5 mg/1 Guanylate Cyclase Stimulators [MoA],Soluble Guanylate Cyclase Stimulator [EPC] 50419-253_97c5f96e-69fd-4943-9f54-e31410e45636 50419-253 HUMAN PRESCRIPTION DRUG Adempas riociguat TABLET, FILM COATED ORAL 20131008 NDA NDA204819 Bayer HealthCare Pharmaceuticals Inc. RIOCIGUAT 2 mg/1 Guanylate Cyclase Stimulators [MoA],Soluble Guanylate Cyclase Stimulator [EPC] 50419-254_97c5f96e-69fd-4943-9f54-e31410e45636 50419-254 HUMAN PRESCRIPTION DRUG Adempas riociguat TABLET, FILM COATED ORAL 20131008 NDA NDA204819 Bayer HealthCare Pharmaceuticals Inc. RIOCIGUAT 2.5 mg/1 Guanylate Cyclase Stimulators [MoA],Soluble Guanylate Cyclase Stimulator [EPC] 50419-320_d03d5411-15ab-47d9-bd6e-ce693bb7404e 50419-320 HUMAN PRESCRIPTION DRUG EOVIST Gadoxetate Disodium INJECTION, SOLUTION INTRAVENOUS 20080703 NDA NDA022090 Bayer HealthCare Pharmaceuticals Inc. GADOXETATE DISODIUM 181.43 mg/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] 50419-325_3f311303-5f6d-4d45-bf6f-1f33e0ad428d 50419-325 HUMAN PRESCRIPTION DRUG Gadavist gadobutrol INJECTION INTRAVENOUS 20110314 NDA NDA201277 Bayer HealthCare Pharmaceuticals Inc. GADOBUTROL 604.72 mg/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] 50419-325_d7f9f769-3a73-4fd1-bcff-c93b2a4d48a5 50419-325 HUMAN PRESCRIPTION DRUG Gadavist gadobutrol INJECTION INTRAVENOUS 20110314 NDA NDA201277 Bayer HealthCare Pharmaceuticals Inc. GADOBUTROL 604.72 mg/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] 50419-340_65b7c500-91de-4403-9802-546487bb4968 50419-340 HUMAN PRESCRIPTION DRUG Ultravist iopromide INJECTION INTRA-ARTERIAL; INTRAVENOUS 20091230 NDA NDA020220 Bayer HealthCare Pharmaceuticals Inc. IOPROMIDE 311.7 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 50419-342_39337486-dc85-4eb1-a888-aea29156fa2c 50419-342 HUMAN PRESCRIPTION DRUG Ultravist iopromide INJECTION INTRA-ARTERIAL 20091230 NDA NDA021425 Bayer HealthCare Pharmaceuticals Inc. IOPROMIDE 498.72 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 50419-342_65b7c500-91de-4403-9802-546487bb4968 50419-342 HUMAN PRESCRIPTION DRUG Ultravist iopromide INJECTION INTRA-ARTERIAL; INTRAVENOUS 20091230 NDA NDA020220 Bayer HealthCare Pharmaceuticals Inc. IOPROMIDE 498.72 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 50419-344_39337486-dc85-4eb1-a888-aea29156fa2c 50419-344 HUMAN PRESCRIPTION DRUG Ultravist iopromide INJECTION INTRA-ARTERIAL 20091230 NDA NDA021425 Bayer HealthCare Pharmaceuticals Inc. IOPROMIDE 623.4 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 50419-344_65b7c500-91de-4403-9802-546487bb4968 50419-344 HUMAN PRESCRIPTION DRUG Ultravist iopromide INJECTION INTRA-ARTERIAL; INTRAVENOUS 20091230 NDA NDA020220 Bayer HealthCare Pharmaceuticals Inc. IOPROMIDE 623.4 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 50419-346_39337486-dc85-4eb1-a888-aea29156fa2c 50419-346 HUMAN PRESCRIPTION DRUG Ultravist iopromide INJECTION INTRA-ARTERIAL 20091230 NDA NDA021425 Bayer HealthCare Pharmaceuticals Inc. IOPROMIDE 768.86 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 50419-346_65b7c500-91de-4403-9802-546487bb4968 50419-346 HUMAN PRESCRIPTION DRUG Ultravist iopromide INJECTION INTRA-ARTERIAL; INTRAVENOUS 20091230 NDA NDA020220 Bayer HealthCare Pharmaceuticals Inc. IOPROMIDE 768.86 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 50419-402_425be71d-812e-4a54-8dea-bb27eb6b4ecf 50419-402 HUMAN PRESCRIPTION DRUG Yasmin drospirenone and ethinyl estradiol KIT 20010511 NDA NDA021098 Bayer HealthCare Pharmaceuticals Inc. 50419-403_81e02158-706e-4e03-88c7-1990a0d6cd9d 50419-403 HUMAN PRESCRIPTION DRUG Safyral Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium KIT 20120213 NDA NDA022574 Bayer HealthCare Pharmaceuticals Inc. 50419-405_0ed216ab-0c5e-4e77-8170-114a2c530ae7 50419-405 HUMAN PRESCRIPTION DRUG Yaz Drospirenone and ethinyl estradiol KIT 20060316 NDA NDA021676 Bayer HealthCare Pharmaceuticals Inc. 50419-407_99e6c01a-25df-4779-8ad9-8fd73810e6dd 50419-407 HUMAN PRESCRIPTION DRUG Beyaz Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium KIT 20101007 NDA NDA022532 Bayer HealthCare Pharmaceuticals Inc. 50419-409_29132896-f94b-4680-bff6-eb95a585c43c 50419-409 HUMAN PRESCRIPTION DRUG Natazia estradiol valerate and estradiol valerate/dienogest KIT 20100506 NDA NDA022252 Bayer HealthCare Pharmaceuticals Inc. 50419-421_a481794e-a3a5-4781-a9e2-b080ef9f8277 50419-421 HUMAN PRESCRIPTION DRUG Mirena Levonorgestrel INTRAUTERINE DEVICE INTRAUTERINE 20091001 NDA NDA021225 Bayer HealthCare Pharmaceuticals Inc. LEVONORGESTREL 52 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 50419-422_54653d3f-4ada-4273-ab83-224f83518ea9 50419-422 HUMAN PRESCRIPTION DRUG Skyla Levonorgestrel INTRAUTERINE DEVICE INTRAUTERINE 20130111 NDA NDA203159 Bayer HealthCare Pharmaceuticals Inc. LEVONORGESTREL 13.5 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 50419-423_dcbd6aa2-b3fa-479a-a676-56ea742962fc 50419-423 HUMAN PRESCRIPTION DRUG Mirena Levonorgestrel INTRAUTERINE DEVICE INTRAUTERINE 20091001 NDA NDA021225 Bayer HealthCare Pharmaceuticals Inc. LEVONORGESTREL 52 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 50419-451_22fefb12-f7d4-4ffa-a346-ef39a3f37ea3 50419-451 HUMAN PRESCRIPTION DRUG Climara Estradiol PATCH TRANSDERMAL 19941222 NDA NDA020375 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 50419-452_22fefb12-f7d4-4ffa-a346-ef39a3f37ea3 50419-452 HUMAN PRESCRIPTION DRUG Climara Estradiol PATCH TRANSDERMAL 19941222 NDA NDA020375 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 50419-453_22fefb12-f7d4-4ffa-a346-ef39a3f37ea3 50419-453 HUMAN PRESCRIPTION DRUG Climara Estradiol PATCH TRANSDERMAL 19980323 NDA NDA020375 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 50419-454_22fefb12-f7d4-4ffa-a346-ef39a3f37ea3 50419-454 HUMAN PRESCRIPTION DRUG Climara Estradiol PATCH TRANSDERMAL 19990305 NDA NDA020375 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL .025 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 50419-455_0da782be-45ae-4c93-9756-312901e83a95 50419-455 HUMAN PRESCRIPTION DRUG Menostar estradiol PATCH TRANSDERMAL 20040608 NDA NDA020375 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL 14 ug/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 50419-456_22fefb12-f7d4-4ffa-a346-ef39a3f37ea3 50419-456 HUMAN PRESCRIPTION DRUG Climara Estradiol PATCH TRANSDERMAL 20030527 NDA NDA020375 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL .0375 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 50419-459_22fefb12-f7d4-4ffa-a346-ef39a3f37ea3 50419-459 HUMAN PRESCRIPTION DRUG Climara Estradiol PATCH TRANSDERMAL 20080103 NDA NDA020375 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL .06 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 50419-482_2cebc275-f2cc-46a8-aac8-0f0e55104f7e 50419-482 HUMAN PRESCRIPTION DRUG Angeliq drospirenone and estradiol TABLET, FILM COATED ORAL 20120229 NDA NDA021355 Bayer HealthCare Pharmaceuticals Inc. DROSPIRENONE; ESTRADIOL .25; .5 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 50419-483_2cebc275-f2cc-46a8-aac8-0f0e55104f7e 50419-483 HUMAN PRESCRIPTION DRUG Angeliq drospirenone and estradiol TABLET, FILM COATED ORAL 20051128 NDA NDA021355 Bayer HealthCare Pharmaceuticals Inc. DROSPIRENONE; ESTRADIOL .5; 1 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 50419-488_52b5a529-e37c-4efc-a849-f37c5770f4c2 50419-488 HUMAN PRESCRIPTION DRUG Nexavar sorafenib TABLET, FILM COATED ORAL 20051220 NDA NDA021923 Bayer HealthCare Pharmaceuticals Inc. SORAFENIB 200 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 50419-491_5821bc3a-0b69-4726-88e0-5abd96aabf6d 50419-491 HUMAN PRESCRIPTION DRUG Climara Pro Estradiol and Levonorgestrel PATCH TRANSDERMAL 20031121 NDA NDA021258 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL; LEVONORGESTREL .045; .015 mg/d; mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 50419-523_da7528ca-d7ae-4064-80fc-387bfa4dea7f 50419-523 HUMAN PRESCRIPTION DRUG Betaseron interferon beta-1b KIT 20090709 BLA BLA103471 Bayer HealthCare Pharmaceuticals Inc. 50419-524_4b57da8f-163c-4ff7-95c8-849d9c77653d 50419-524 HUMAN PRESCRIPTION DRUG Betaseron interferon beta-1b KIT 20090709 BLA BLA103471 Bayer HealthCare Pharmaceuticals Inc. 50419-701_81b28c19-5051-4aa1-9174-bae4305baaa1 50419-701 HUMAN PRESCRIPTION DRUG Adalat CC nifedipine TABLET, FILM COATED ORAL 19930421 NDA NDA020198 Bayer HealthCare Pharmaceuticals Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50419-702_81b28c19-5051-4aa1-9174-bae4305baaa1 50419-702 HUMAN PRESCRIPTION DRUG Adalat CC nifedipine TABLET, FILM COATED ORAL 19930421 NDA NDA020198 Bayer HealthCare Pharmaceuticals Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50419-703_81b28c19-5051-4aa1-9174-bae4305baaa1 50419-703 HUMAN PRESCRIPTION DRUG Adalat CC nifedipine TABLET, FILM COATED ORAL 19930421 NDA NDA020198 Bayer HealthCare Pharmaceuticals Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50419-747_34ce1cdd-648e-4f1e-8512-bf3d4cc22eb9 50419-747 HUMAN PRESCRIPTION DRUG Biltricide praziquantel TABLET, FILM COATED ORAL 20110421 NDA NDA018714 Bayer HealthCare Pharmaceuticals Inc. PRAZIQUANTEL 600 mg/1 Antihelminthic [EPC] 50419-754_f4cb7384-92f6-43a5-85b7-99b8cd8b5fc4 50419-754 HUMAN PRESCRIPTION DRUG Cipro ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 19871022 NDA NDA019537 Bayer HealthCare Pharmaceuticals Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 50419-758_f4cb7384-92f6-43a5-85b7-99b8cd8b5fc4 50419-758 HUMAN PRESCRIPTION DRUG Cipro ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 19871022 NDA NDA019537 Bayer HealthCare Pharmaceuticals Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 50419-759_fa9645f4-0985-49e1-972f-d7e688bd77dd 50419-759 HUMAN PRESCRIPTION DRUG Cipro ciprofloxacin SOLUTION, CONCENTRATE INTRAVENOUS 20090422 NDA NDA019857 Bayer HealthCare Pharmaceuticals Inc. CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 50419-773_f4cb7384-92f6-43a5-85b7-99b8cd8b5fc4 50419-773 HUMAN PRESCRIPTION DRUG Cipro ciprofloxacin KIT 19970926 NDA NDA020780 Bayer HealthCare Pharmaceuticals Inc. 50419-777_f4cb7384-92f6-43a5-85b7-99b8cd8b5fc4 50419-777 HUMAN PRESCRIPTION DRUG Cipro ciprofloxacin KIT 19970926 NDA NDA020780 Bayer HealthCare Pharmaceuticals Inc. 50419-788_06e4d950-f13f-4829-a954-f5db84965bb8 50419-788 HUMAN PRESCRIPTION DRUG Cipro ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121001 NDA NDA021473 Bayer HealthCare Pharmaceuticals Inc. CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 212.6; 287.5 mg/1; 1/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 50419-789_06e4d950-f13f-4829-a954-f5db84965bb8 50419-789 HUMAN PRESCRIPTION DRUG Cipro ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121001 NDA NDA021473 Bayer HealthCare Pharmaceuticals Inc. CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 452.2; 574.9 mg/1; 1/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 50419-825_99385d0c-c315-46de-8e16-01557c7e0537 50419-825 HUMAN PRESCRIPTION DRUG Finacea azelaic acid GEL TOPICAL 20021224 NDA NDA021470 Bayer HealthCare Pharmaceuticals Inc. AZELAIC ACID .15 g/g Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE] 50419-828_0e276ec9-8b14-4618-8219-5f3ad4bbc273 50419-828 HUMAN PRESCRIPTION DRUG DESONATE desonide GEL TOPICAL 20061020 NDA NDA021844 Bayer HealthCare Pharmaceuticals Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50419-861_a1960c25-9698-4abd-86e7-d863596010ae 50419-861 HUMAN PRESCRIPTION DRUG Precose Acarbose TABLET ORAL 20080130 NDA NDA020482 Bayer HealthCare Pharmaceuticals Inc. ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 50419-862_a1960c25-9698-4abd-86e7-d863596010ae 50419-862 HUMAN PRESCRIPTION DRUG Precose Acarbose TABLET ORAL 20080130 NDA NDA020482 Bayer HealthCare Pharmaceuticals Inc. ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 50419-863_a1960c25-9698-4abd-86e7-d863596010ae 50419-863 HUMAN PRESCRIPTION DRUG Precose Acarbose TABLET ORAL 20080130 NDA NDA020482 Bayer HealthCare Pharmaceuticals Inc. ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 50421-002_0c57f630-0294-41c0-b423-a4cb1d4c3f40 50421-002 HUMAN OTC DRUG Camphor, Menthol Camphor, Menthol GEL TOPICAL 20100113 OTC MONOGRAPH FINAL part348 Active & Innovative Inc. CAMPHOR; MENTHOL 3.4; 8.5 g/85g; g/85g 50421-004_7576e9e6-fcc8-437e-bbd4-3e6a4b2dcb73 50421-004 HUMAN OTC DRUG Camphor, Menthol Camphor, Menthol OINTMENT TOPICAL 20100113 OTC MONOGRAPH FINAL part348 Active & Innovative Inc. CAMPHOR; MENTHOL 4.6; 4.6 g/115g; g/115g 50425-010_9f3a8e4f-c833-4e1c-9c41-04ad164a8105 50425-010 HUMAN OTC DRUG Scrub Care Povidone Iodine Cleansing Scrub povidone iodine SOLUTION TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part333A CareFusion 213 LLC POVIDONE-IODINE 7.5 mg/mL 50425-011_790b6520-aa91-4192-82d9-49f01fee0e8e 50425-011 HUMAN OTC DRUG Scrub Care Povidone Iodine Topical Paint providone iodine SOLUTION TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part333A CareFusion 213 LLC POVIDONE-IODINE 10 mg/mL 50428-0030_285f23e4-84e6-4930-ba12-c7626713d2cb 50428-0030 HUMAN OTC DRUG Alcohol Wipe Isopropyl Alcohol SWAB TOPICAL 20100720 OTC MONOGRAPH NOT FINAL part333A Dorel Juvenile Group ISOPROPYL ALCOHOL .7 mL/1 50428-3001_51c10961-bcf8-49d1-9b56-4825290b319e 50428-3001 HUMAN OTC DRUG Naturals by Safety 1st Zinc Oxide OINTMENT TOPICAL 20100201 OTC MONOGRAPH FINAL part347 Dorel Juvenile Group ZINC OXIDE 8.8 g/88mL 50436-0025_cb65d5d0-8124-4572-85d1-c8fbdad5f7d0 50436-0025 HUMAN PRESCRIPTION DRUG Mupirocin mupirocin OINTMENT TOPICAL 20051130 ANDA ANDA065192 Unit Dose Services MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 50436-0026_96af229a-fee6-4de8-9dac-fb339ca79330 50436-0026 HUMAN PRESCRIPTION DRUG FROVA frovatriptan succinate TABLET, FILM COATED ORAL 20011108 NDA NDA021006 Unit Dose Services FROVATRIPTAN SUCCINATE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 50436-0053_202c6445-da39-490c-a349-eb032341cfdd 50436-0053 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Unit Dose Services ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-0054_6490063f-26c4-49e7-b04e-5fe839c0097c 50436-0054 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA078777 Unit Dose Services ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-0098_934f8b5f-82e2-4657-9411-ea35f775b0f4 50436-0098 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Unit Dose Services MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-0102_39fbd627-211b-48b7-bfb5-df0ab4888762 50436-0102 HUMAN OTC DRUG Promolaxin Docusate sodium TABLET ORAL 20110415 OTC MONOGRAPH NOT FINAL part334 Unit Dose Services DOCUSATE SODIUM 100 mg/1 50436-0105_55b291e3-8601-4b6b-8aad-94bb16dc6cec 50436-0105 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 19980508 ANDA ANDA074918 Unit Dose Services NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] 50436-0106_ce482ad0-7291-45f3-811a-11767252179e 50436-0106 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19880225 ANDA ANDA062881 Unit Dose Services AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 50436-0107_c840a770-bd3f-4595-97bc-f605e02efc35 50436-0107 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20080311 ANDA ANDA065470 Unit Dose Services MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 50436-0108_40e8ceed-a83b-478e-b339-1e364e4d6151 50436-0108 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20080311 ANDA ANDA065470 Unit Dose Services MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 50436-0117_51a8f729-cedf-4974-b630-4528f2222f5a 50436-0117 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Unit Dose Services CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 50436-0119_8c37f842-08eb-429f-b1ee-c6466a6efbec 50436-0119 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100715 ANDA ANDA090931 Unit Dose Services TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 50436-0120_176ad798-4f46-4392-a912-c7d39f3f4787 50436-0120 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Unit Dose Services SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50436-0121_09aa1b4a-e7a8-4483-814c-d3849269eaed 50436-0121 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Unit Dose Services SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50436-0122_40e3d392-b2c6-4a95-b72a-5eac2d8592c2 50436-0122 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Unit Dose Services SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50436-0124_55684035-a125-4247-b0d4-b93bee3ed628 50436-0124 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Unit Dose Services SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50436-0125_59fb39a0-6024-477b-a329-239665dcbe1e 50436-0125 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Unit Dose Services SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50436-0127_625b667c-d966-4f91-a9cd-0715b830ccea 50436-0127 HUMAN OTC DRUG Aspir Low Aspirin TABLET ORAL 20110524 OTC MONOGRAPH FINAL part343 Unit Dose Services ASPIRIN 81 mg/1 50436-0128_3afa1966-3613-4e1b-b9ab-5b2712df183e 50436-0128 HUMAN OTC DRUG Aspir Low Aspirin TABLET ORAL 20110524 OTC MONOGRAPH FINAL part343 Unit Dose Services ASPIRIN 81 mg/1 50436-0131_f67ef87e-3209-481a-b597-11ce3b7266f6 50436-0131 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Unit Dose Services ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 50436-0132_7c7231f4-956d-4be1-a4ea-c60b06832a7f 50436-0132 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET ORAL 20070106 ANDA ANDA077851 Unit Dose Services ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 50436-0133_8a7aaa71-57bb-4005-a6db-29a835889e73 50436-0133 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Unit Dose Services ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 50436-0155_f3fcf2c8-d953-43fb-ac35-8fb5a9250599 50436-0155 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Unit Dose Services CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 50436-0156_c6420f63-e85d-431d-98f8-f093a0c20ec3 50436-0156 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20121226 ANDA ANDA077290 Unit Dose Services OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 50436-0157_4b1f7be7-d6cc-4948-88b1-d9f9a4807185 50436-0157 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20040818 ANDA ANDA076368 Unit Dose Services POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 50436-0158_8b35e735-7a95-41cd-855d-b016f43b3c4c 50436-0158 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20121226 ANDA ANDA077290 Unit Dose Services OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 50436-0160_2189c8c9-9a3d-419b-839e-044bddb7ccd8 50436-0160 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Unit Dose Services ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50436-0165_12eb3b1e-df09-43e8-be5f-55e765790b61 50436-0165 HUMAN OTC DRUG Dendracin Neurodendraxcin Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20110722 OTC MONOGRAPH NOT FINAL part348 Unit Dose Services CAPSAICIN; MENTHOL; METHYL SALICYLATE .015; 6; 18 mL/60mL; mL/60mL; mL/60mL 50436-0171_4ad875c6-37c4-4a39-803c-120c04c74ca9 50436-0171 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 Unit Dose Services FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 50436-0172_401427a8-9e96-4bb1-ba27-f72bdcc9445e 50436-0172 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20100201 ANDA ANDA076509 Unit Dose Services FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 50436-0193_33ac3b0e-821a-42fb-b0cd-36cfba66e8b3 50436-0193 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 Unit Dose Services ESZOPICLONE 3 mg/1 CIV 50436-0195_0130cca8-a739-4d5b-830b-31f803367fbc 50436-0195 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20111207 ANDA ANDA074569 Unit Dose Services CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-0201_7eae31cb-8683-4eb0-9dfa-57bfa0a1b29d 50436-0201 HUMAN PRESCRIPTION DRUG PROVIGIL modafinil TABLET ORAL 19981224 NDA NDA020717 Unit Dose Services MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 50436-0248_b61f665d-b584-47c3-b1aa-c42e07853aa5 50436-0248 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20041216 ANDA ANDA076706 Unit Dose Services METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 50436-0262_f85651a3-c37e-4e0a-bb22-f80e489e2ed9 50436-0262 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980311 ANDA ANDA075074 Unit Dose Services ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-0263_f7e9efb4-6748-4225-a66b-809c7a611945 50436-0263 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980430 ANDA ANDA075078 Unit Dose Services ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-0264_1dd497d7-68d3-439e-8fa0-552c346689f9 50436-0264 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101230 ANDA ANDA075665 Unit Dose Services ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-0274_bf821697-e560-4edf-b8ab-15673ad6579f 50436-0274 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20070917 ANDA ANDA077222 Unit Dose Services FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50436-0284_375a14e1-3633-4eef-b33f-bac32617d6d6 50436-0284 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Unit Dose Services AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50436-0291_5456e371-00d0-4689-bd69-be0942714410 50436-0291 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SYRUP ORAL 20130715 ANDA ANDA090102 Unit Dose Services RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 50436-0302_a4254f4a-ccec-401c-951a-3bbf19754c11 50436-0302 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole Sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA090678 Unit Dose Services RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 50436-0310_9bbac3e3-618e-492c-a98b-d363b4f5e005 50436-0310 HUMAN PRESCRIPTION DRUG PENNSAID diclofenac sodium LIQUID TOPICAL 20100405 NDA NDA020947 Unit Dose Services DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-0324_c3246397-14a9-4801-8d8a-6766b3845a51 50436-0324 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Unit Dose Services DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 50436-0331_d1109efd-c814-40d1-95a2-ad59ad69172b 50436-0331 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Unit Dose Services ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 50436-0333_631f01a7-6e83-4688-bf05-d5e4965589ec 50436-0333 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 19941001 OTC MONOGRAPH FINAL part341 Unit Dose Services PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 CI 50436-0340_445f4a64-295f-4a38-8b99-7e6b37425fe3 50436-0340 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 19830202 ANDA ANDA062421 Unit Dose Services DOXYCYCLINE HYCLATE 100 mg/1 50436-0405_0bc67b2c-df1f-421e-a8ec-7f29ddeef6f1 50436-0405 HUMAN PRESCRIPTION DRUG Quazepam QUAZEPAM TABLET ORAL 20130808 NDA NDA018708 Unit Dose Services QUAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-0446_f51eae15-0ecc-4c41-9fe3-8b513c93ac91 50436-0446 HUMAN PRESCRIPTION DRUG FINASTERIDE FINASTERIDE TABLET, FILM COATED ORAL 20110818 ANDA ANDA090507 Unit Dose Services FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 50436-0555_9834a2e1-405b-40c1-b272-10058685cb87 50436-0555 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Unit Dose Services RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 50436-0576_d10a64d5-9a80-4710-ba19-380c1acfc8ff 50436-0576 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride SOLUTION ORAL 19910601 ANDA ANDA072744 Unit Dose Services METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 50436-0597_a8385a35-1cc3-40c4-bfcb-a985410e3529 50436-0597 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20120515 ANDA ANDA202418 Unit Dose Services LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 50436-0736_d0fd1ce3-d0ce-4ddf-a4a8-bc43a5851420 50436-0736 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 Unit Dose Services HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50436-0759_76969a41-c4ac-459b-ae71-debb016380be 50436-0759 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20050425 ANDA ANDA076913 Unit Dose Services PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50436-0775_3644ba34-129c-4cd6-ae72-3bf5bac16667 50436-0775 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19950710 ANDA ANDA040014 Unit Dose Services LIDOCAINE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 50436-0822_1cb68bc4-693f-4c8d-859c-5513917f5000 50436-0822 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120314 NDA NDA022370 Unit Dose Services TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 50436-0823_a815e436-6cf7-4b22-bad9-385d28dc34b2 50436-0823 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20110921 ANDA ANDA078783 Unit Dose Services TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 50436-0824_6305c108-8a53-4989-a00d-ea8aa5fcb66d 50436-0824 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111230 ANDA ANDA091607 Unit Dose Services TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 50436-0830_123ac5cd-d04d-45d4-a6fe-ab2fe3326d5c 50436-0830 HUMAN PRESCRIPTION DRUG Neomycin Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19950913 ANDA ANDA064135 Unit Dose Services DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50436-0843_61272e30-5810-4806-9e00-077842768b05 50436-0843 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 Unit Dose Services TRIAMCINOLONE ACETONIDE 1 mg/g 50436-0872_4ab52425-8877-457f-9999-41bea8365e45 50436-0872 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20070507 ANDA ANDA076345 Unit Dose Services GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 50436-0873_edf0c3c8-38e1-4a7c-b338-e9397fc6ce5f 50436-0873 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20110103 ANDA ANDA076345 Unit Dose Services GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 50436-0875_2c17dbf3-01fd-4ea6-9e7b-3169a43961f7 50436-0875 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 Unit Dose Services INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-0902_bd19b1e4-80aa-45dc-a462-45c8e04afc63 50436-0902 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19830419 NDA AUTHORIZED GENERIC NDA018553 Unit Dose Services PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50436-0913_c33e7edd-9a2a-4669-b31d-c5cafa26de3d 50436-0913 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 Unit Dose Services CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-0915_dad07d13-ddef-4ade-ad3c-026a0dd0e7ad 50436-0915 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20111207 ANDA ANDA074569 Unit Dose Services CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-0916_42d57a86-f96b-48f8-b2f4-0f1f45ce9921 50436-0916 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Unit Dose Services CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-0917_cf394877-82cb-4b0a-96bb-094d21885195 50436-0917 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20090101 ANDA ANDA077031 Unit Dose Services CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-0919_32630cfc-d744-4696-b991-ffb7cfc3bc30 50436-0919 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Unit Dose Services BUSPIRONE HYDROCHLORIDE 15 mg/1 50436-0922_d091c716-89ce-4bc2-8870-249a040fc6b6 50436-0922 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Unit Dose Services FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-0923_7675fb6d-3904-4b34-8039-5bda7632d156 50436-0923 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine CAPSULE ORAL 20050720 ANDA ANDA076990 Unit Dose Services FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-0924_38649f64-ac80-4d02-9cfe-fb2f86ee0992 50436-0924 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Unit Dose Services FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-1006_0a3812aa-c37c-436d-9fc0-5cb02da7118c 50436-1006 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20080606 ANDA ANDA077239 Unit Dose Services ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 50436-1074_17fd7416-2452-4465-9768-61609bbd94fe 50436-1074 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 Unit Dose Services FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 50436-1182_b7efbdca-bb2f-4e32-b645-5c0195374bc1 50436-1182 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19950928 ANDA ANDA074376 Unit Dose Services DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-1222_c28060d7-2686-4881-b97f-12c340059861 50436-1222 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20100915 OTC MONOGRAPH NOT FINAL part334 Unit Dose Services DOCUSATE SODIUM 100 mg/1 50436-1223_1d4c47c9-f1c3-451a-8847-c6783fe7ad7f 50436-1223 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Unit Dose Services DOCUSATE SODIUM 100 mg/1 50436-1263_e3aa4efc-14c4-4730-a230-710a9f4b6e71 50436-1263 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Unit Dose Services GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50436-1265_574818b7-fc76-4261-92ed-fd4029582ddb 50436-1265 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Unit Dose Services PREGABALIN 50 mg/1 CV 50436-1330_0f6da3f6-5b32-497c-831d-a8ef4c552392 50436-1330 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine PATCH CUTANEOUS 20130915 ANDA ANDA200675 Unit Dose Services LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 50436-1331_4bed9959-8b35-491d-9291-940822cb915d 50436-1331 HUMAN PRESCRIPTION DRUG LIDODERM lidocaine PATCH CUTANEOUS 19990320 NDA NDA020612 Unit Dose Services LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 50436-1332_c58fba36-c064-45c0-9fc2-dab2e794efbe 50436-1332 HUMAN PRESCRIPTION DRUG Flector Diclofenac Epolamine PATCH TOPICAL 20080114 NDA NDA021234 Unit Dose Services DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-1334_0a7a9a5c-9277-4345-957e-261c8ae79195 50436-1334 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine GEL TOPICAL 20130301 UNAPPROVED DRUG OTHER Unit Dose Services LIDOCAINE 30 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 50436-1873_4aec6edb-74e0-450f-ac2c-e96d1b0c97a9 50436-1873 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19930701 ANDA ANDA072801 Unit Dose Services METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 50436-2000_12949a8e-4da0-4f92-b68f-17aaffb531bd 50436-2000 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 Unit Dose Services LISINOPRIL 5 mg/1 50436-2002_66b45a0d-198f-4913-a716-01c898806537 50436-2002 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20090801 ANDA ANDA077789 Unit Dose Services CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] 50436-2144_a05e1c22-f236-4cf2-bfb4-43211cd1619a 50436-2144 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20050428 ANDA ANDA088799 Unit Dose Services HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50436-2607_01d7abc8-4803-4256-b88a-a9b280569268 50436-2607 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 Unit Dose Services CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 50436-2608_26638658-da80-4eb1-8bf6-aa95ba721144 50436-2608 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Unit Dose Services CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 50436-2609_2d885756-e1ba-4a13-bbd9-6d1b20d938ba 50436-2609 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Unit Dose Services CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 50436-2899_59879248-6eba-4b6e-82a7-feecb3960052 50436-2899 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20100908 ANDA ANDA075849 Unit Dose Services OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-3000_7dacd6b3-065b-4cb9-8b0a-ccd58e1466ed 50436-3000 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Unit Dose Services LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50436-3011_42ed0ece-538e-423c-9ba7-2364113d712c 50436-3011 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET, FILM COATED ORAL 20060824 ANDA ANDA077525 Unit Dose Services GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50436-3024_3b2d9675-366a-4c74-82a1-7cc37e635ec0 50436-3024 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 Unit Dose Services METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 50436-3026_1a416e51-612f-43a2-ac6f-c84c8a4ae537 50436-3026 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Unit Dose Services ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 50436-3027_b3ad9e9f-b225-4aaf-9154-3391c9764bbd 50436-3027 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET, COATED ORAL 20091001 ANDA ANDA071586 Unit Dose Services ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 50436-3028_6a904e3d-d9e1-47c4-a1c2-a57b7e4fd629 50436-3028 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Unit Dose Services ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 50436-3030_efa32477-9a65-4f9f-bc2d-02c059bb8a4c 50436-3030 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Unit Dose Services ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 50436-3031_198fb810-963a-45d1-a730-0d3b5a720701 50436-3031 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090107 Unit Dose Services ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 50436-3071_821168f0-dcb1-4481-89af-44837eeb3bc7 50436-3071 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 Unit Dose Services AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 50436-3072_4b0c6c05-b142-4d37-abd4-2ae451dc8a1f 50436-3072 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 Unit Dose Services AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 50436-3073_17d7c029-8e35-482d-80b6-c6c0377d9e09 50436-3073 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Unit Dose Services AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 50436-3074_f71f3d45-ee67-415e-b699-780dff07df83 50436-3074 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085967 Unit Dose Services AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 50436-3075_52d01ac7-5d99-4636-9c92-605d9f134d7f 50436-3075 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Unit Dose Services AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 50436-3098_9c938a00-3ee9-4729-84c8-97e2194064a5 50436-3098 HUMAN PRESCRIPTION DRUG Silver Sulfadiazene Silver Sulfadiazine CREAM TOPICAL 19820225 NDA NDA018578 Unit Dose Services SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 50436-3099_8f71d414-5762-44b5-8cd1-02af10abb95a 50436-3099 HUMAN PRESCRIPTION DRUG Silver Sulfadiazene Silver Sulfadiazine CREAM TOPICAL 19820225 NDA NDA018578 Unit Dose Services SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 50436-3101_1fbb4409-8ca5-481d-9261-57c5e9fe06b4 50436-3101 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL 19950703 ANDA ANDA074076 Unit Dose Services LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 50436-3121_ee26ef81-935c-4472-b81b-897664dfc60e 50436-3121 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010319 NDA NDA021153 Unit Dose Services ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 50436-3125_e719bdde-8fe7-40bc-b4d6-7dea22ca977d 50436-3125 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20021104 ANDA ANDA075410 Unit Dose Services OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 50436-3126_2b25bea8-a8d0-4041-a799-6338e1b3cf1e 50436-3126 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE ORAL 20101013 ANDA ANDA075576 Unit Dose Services OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 50436-3127_a06d0dc0-cd3c-4db8-8a3a-ee7f4ea9f991 50436-3127 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 Unit Dose Services OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 50436-3129_72ac910d-3e08-40f3-8cb6-7c3d15909e1c 50436-3129 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20111116 ANDA ANDA065096 Unit Dose Services AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 50436-3135_be8d670b-9617-4ce2-bdc6-16c842299b22 50436-3135 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Unit Dose Services CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 50436-3138_40901a58-57b6-44fe-8f24-7f2b52455724 50436-3138 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20070917 ANDA ANDA077222 Unit Dose Services FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50436-3140_3d3d2f01-4c85-49a9-a3e8-32528f0a9c4e 50436-3140 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Unit Dose Services BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 50436-3145_2525a0b7-7131-48a6-9691-f37019e7bbfd 50436-3145 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Unit Dose Services BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 50436-3146_5ad48c1d-1c87-48d5-9da7-4426fcae1e40 50436-3146 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Unit Dose Services BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 50436-3148_df3a2ee2-e238-47ce-a752-6a21b548ed59 50436-3148 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Unit Dose Services CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 50436-3155_6a9ba3db-c229-4204-97a2-f9cbc9121e56 50436-3155 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090324 ANDA ANDA078459 Unit Dose Services METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50436-3171_8654ef43-8538-471e-8c25-afc8fb61995a 50436-3171 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 Unit Dose Services ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50436-3173_ce0d0b23-7e7d-47ae-b0d2-c1000eca57af 50436-3173 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040526 Unit Dose Services PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50436-3174_c77bb48b-eee7-466b-8a86-65692c3ca658 50436-3174 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20031023 ANDA ANDA040525 Unit Dose Services PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50436-3175_5e343fe9-7731-42b9-9467-0f5dc60d808d 50436-3175 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 Unit Dose Services PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50436-3182_1de46012-2483-4aab-afc1-ca29ffa62663 50436-3182 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20121226 ANDA ANDA077290 Unit Dose Services OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 50436-3227_f1762dc1-b238-47bb-b5ab-33c0156724c5 50436-3227 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20080529 ANDA ANDA040779 Unit Dose Services ACETAMINOPHEN; CODEINE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 50436-3330_919248e4-fdf1-491e-bc4f-8d151ff149fa 50436-3330 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Unit Dose Services ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50436-3331_da33bf05-b927-4d96-b28c-33e2faa3e5a0 50436-3331 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Unit Dose Services ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50436-3332_87e49c9b-9900-4d5f-b781-2178fb9c4a68 50436-3332 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100610 ANDA ANDA077443 Unit Dose Services ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50436-3367_02ae6c1c-8c9f-44cb-8449-35ad58b3d1c8 50436-3367 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19740930 ANDA ANDA084285 Unit Dose Services DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 50436-3415_0ea5b443-f6a1-4bbe-85b1-50f6c58c6c47 50436-3415 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 Unit Dose Services CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 50436-3435_89652478-b40a-46a7-81f5-9fcb0f3ef887 50436-3435 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070227 ANDA ANDA040755 Unit Dose Services CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CV 50436-3444_3316ce7e-eab0-45f2-99c1-cd07a7a17226 50436-3444 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822 ANDA ANDA089859 Unit Dose Services CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 50436-3501_cba498ce-6f23-44b4-82e4-dc1c7074369d 50436-3501 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 Unit Dose Services LORATADINE 10 mg/1 50436-3502_7ad251af-9172-49fa-8b3c-2aaf7cffc066 50436-3502 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 Unit Dose Services LORATADINE 10 mg/1 50436-3523_93ef9a2c-e2c2-4056-b5f0-d352f6e90a56 50436-3523 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070974 Unit Dose Services CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 50436-3524_d13d65c3-663c-4463-88eb-8ff6be430d4d 50436-3524 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Unit Dose Services CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 50436-3526_3bc39bfa-3e8d-4ac8-8e29-3294741b98ed 50436-3526 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070923 Unit Dose Services CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 50436-3592_d8544813-af10-4c49-833f-13126c36e992 50436-3592 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071321 Unit Dose Services DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-3593_083b3df5-a0d5-40ac-bbd8-2de454fe7dd9 50436-3593 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Unit Dose Services DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-3594_6a955499-253f-4acf-bae5-8bdddbee0662 50436-3594 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 Unit Dose Services DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 50436-3613_f85242e6-e381-4100-bcf9-bde386101ba3 50436-3613 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062936 Unit Dose Services PENICILLIN V POTASSIUM 250 mg/1 50436-3621_c775bdd4-b389-4b09-ab68-75fcd73e29bf 50436-3621 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20071017 NDA NDA022122 Unit Dose Services DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-3622_376f2ced-6874-4b62-aa44-c04ea9524a48 50436-3622 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20100723 ANDA ANDA091004 Unit Dose Services ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 50436-3762_b7a373d6-534b-42ad-aee0-7b68174f4e66 50436-3762 HUMAN OTC DRUG Banophen Diphenhydramine Hydrochloride CAPSULE ORAL 20090102 OTC MONOGRAPH FINAL part348 Unit Dose Services DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 50436-3779_9fe00c5c-dc3a-428f-b648-1031e5cb2828 50436-3779 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 NDA AUTHORIZED GENERIC NDA020699 Unit Dose Services VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-3800_174ff82e-163c-4395-b7fe-f0c1408168ba 50436-3800 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Unit Dose Services PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50436-3840_79c8510c-6a8f-4e2c-bdea-4db96e02bb08 50436-3840 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Unit Dose Services FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 50436-3841_21fd8281-0b17-4f59-8fab-c719a2126fd0 50436-3841 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Unit Dose Services FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 50436-3845_b4b93a91-4b55-4572-8149-2906934821c1 50436-3845 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091202 ANDA ANDA040625 Unit Dose Services FOLIC ACID 1 mg/1 50436-3897_cb27b262-104a-4caf-85ec-e8b616e0c977 50436-3897 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076312 Unit Dose Services MIRTAZAPINE 15 mg/1 50436-3912_463898a2-2da9-43d9-8d4b-73418aec198a 50436-3912 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen HYDROCODONE BITARTRATE, ACETAMINOPHEN TABLET ORAL 20120517 ANDA ANDA040846 Unit Dose Services ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 50436-3913_ce22ad54-f32a-41db-b952-ee29dde30398 50436-3913 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131210 ANDA ANDA201447 Unit Dose Services ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 50436-3914_76b880c4-727d-4a5d-ad3c-7cd10d963355 50436-3914 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19881202 ANDA ANDA089971 Unit Dose Services ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 50436-3915_003aaa11-15c7-472a-9bcd-ff6d5feb35cf 50436-3915 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19960412 ANDA ANDA040157 Unit Dose Services ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 50436-3917_12a1d12d-9af3-42a1-93cd-00bbb26fca93 50436-3917 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19950929 20150131 ANDA ANDA040094 Unit Dose Services ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 50436-3918_d7c223c8-797e-4d78-ad1d-11505dc8a593 50436-3918 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Unit Dose Services ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 50436-3919_a6e7408f-1076-4813-b80d-3b95ea520dc3 50436-3919 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100820 ANDA ANDA040807 Unit Dose Services HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 50436-3922_621d3adf-7aba-4c5b-b48f-a089776d43ca 50436-3922 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070501 ANDA ANDA084325 Unit Dose Services HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 50436-3933_49b60355-e07d-4bd5-87e2-04198905eb71 50436-3933 HUMAN PRESCRIPTION DRUG Paroxetine PAROXETINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Unit Dose Services PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-3944_3e8b1162-1e75-459e-a710-5764c492d337 50436-3944 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Unit Dose Services ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 50436-3945_7dba7338-f6f8-4981-ba26-8db004f75729 50436-3945 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100607 ANDA ANDA075522 Unit Dose Services ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 50436-3953_3a2ed026-0404-4b15-87bc-dd7a214de600 50436-3953 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 50436-3954_c65fa8af-2972-47bb-87a1-efd5c3911134 50436-3954 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM ANHYDROUS .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 50436-3959_20e837a8-d5b0-4d47-8f26-e90be4572a4c 50436-3959 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070103 ANDA ANDA071403 Unit Dose Services LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-3960_50bbd5be-47a9-4bab-a599-214055cfcaa0 50436-3960 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 Unit Dose Services LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-3961_9f4d3e6d-3dc1-461d-bb62-838acea5422f 50436-3961 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070108 ANDA ANDA071141 Unit Dose Services LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-3974_934e68b3-4b24-4c40-b45c-c06dc1daf24c 50436-3974 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 20121012 ANDA ANDA072741 Unit Dose Services LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 50436-3986_bde4458c-5c7a-493e-bc32-5a37b08de19d 50436-3986 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride TABLET ORAL 20100604 ANDA ANDA040659 Unit Dose Services MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 50436-3988_9b79bbc8-42d7-4a0a-90dc-7d89474ec429 50436-3988 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087128 Unit Dose Services MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 50436-3995_dfe7ca31-e876-4de6-84f7-7a58dc269781 50436-3995 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 Unit Dose Services LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 50436-3996_be9141ac-45ad-47a7-8eb9-15414a5b0e6f 50436-3996 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 Unit Dose Services LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 50436-4000_ab6e67ce-575a-42f9-b0d2-a1ad778bd74a 50436-4000 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 Unit Dose Services LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50436-4026_6511a67d-9005-4b72-a3b3-bd4f5e04e170 50436-4026 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Unit Dose Services METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 50436-4027_99f54db5-9caa-48b8-a87e-307396763071 50436-4027 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Unit Dose Services METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 50436-4032_091f60cc-8abe-432f-b8f3-3c9d29fcd2b1 50436-4032 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110822 ANDA ANDA070035 Unit Dose Services METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 50436-4033_1523d1bd-a8c3-400a-b859-196f34ae2557 50436-4033 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110822 ANDA ANDA070044 Unit Dose Services METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 50436-4034_e857f31d-5fbd-40d0-abb2-f4ff14630455 50436-4034 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Unit Dose Services HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 50436-4037_a640ff30-da86-4523-9848-3499265ab745 50436-4037 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 Unit Dose Services METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50436-4068_8a7e5a51-46f7-4529-a6fb-bd4c193a4a59 50436-4068 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Unit Dose Services NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50436-4069_4adbeb08-f05d-479e-9d87-78264b20385d 50436-4069 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Unit Dose Services NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50436-4164_70fac393-0c33-43da-a152-61dfd38ae346 50436-4164 HUMAN PRESCRIPTION DRUG DIETHYLPROPION HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE TABLET ORAL 20101227 ANDA ANDA201212 Unit Dose Services DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50436-4165_9e05c1be-cc73-45ad-88c5-a80e34c2b53b 50436-4165 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20030905 ANDA ANDA040535 Unit Dose Services ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 50436-4166_57d0373f-fd4d-43f2-b714-108789c7f17f 50436-4166 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20030905 ANDA ANDA040535 Unit Dose Services ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 50436-4233_c26a741e-36fc-4835-bd3a-81d7a2105d0b 50436-4233 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Unit Dose Services BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 50436-4234_a65310f8-e16a-4bab-a2cc-a724e92ecb5c 50436-4234 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Unit Dose Services BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 50436-4311_15284618-61c9-4739-b264-5fb65e05a16d 50436-4311 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19981120 ANDA ANDA074726 Unit Dose Services POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 50436-4313_df6fd902-9381-44a3-920a-293f8063c85f 50436-4313 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Unit Dose Services PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50436-4314_0e77c0f5-40dd-46e8-9c74-026b50e08dc1 50436-4314 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Unit Dose Services PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50436-4315_ca76c502-e7ce-43ac-b1e7-2aa607dd01db 50436-4315 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070810 ANDA ANDA078494 Unit Dose Services PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50436-4324_2ab26951-c3f2-44a5-903a-1ad2b9dded0d 50436-4324 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 Unit Dose Services PREDNISONE 5 mg/1 50436-4325_2b6c52d4-8fbc-4b9c-ab10-48d9291eb5f2 50436-4325 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19851204 ANDA ANDA088832 Unit Dose Services PREDNISONE 10 mg/1 50436-4326_81d67588-8000-4cc0-8a53-2960fd1fd224 50436-4326 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19740226 ANDA ANDA083677 Unit Dose Services PREDNISONE 20 mg/1 50436-4352_5164624d-0073-4bea-805a-5dc61f545b47 50436-4352 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Unit Dose Services ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 50436-4353_b2536193-1c24-4156-b6ec-c45e66359d9c 50436-4353 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Unit Dose Services ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 50436-4356_11041fca-c563-494f-8fed-371dae32cd08 50436-4356 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 Unit Dose Services AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 50436-4357_3ad31e0f-a476-4d19-b2c0-a610458fe6c7 50436-4357 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20111024 ANDA ANDA065153 Unit Dose Services AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 50436-4364_562abba5-b811-4704-94b1-5e4e14479b1c 50436-4364 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Unit Dose Services LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50436-4365_2f4882b5-bb63-4662-92a2-220435af4c26 50436-4365 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA074787 Unit Dose Services LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50436-4379_3443264f-d386-4ef4-b255-45d300da4e12 50436-4379 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20120717 ANDA ANDA040712 Unit Dose Services PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CIV 50436-4388_c0c158b6-c848-4804-adfa-152464df982c 50436-4388 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Unit Dose Services PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 50436-4477_f0d72798-f2b6-4cad-a3f8-aaa12c2e4898 50436-4477 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19860723 ANDA ANDA089424 Unit Dose Services SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 50436-4500_8a1deae8-2830-45c4-8ffe-319aa64ac491 50436-4500 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Unit Dose Services DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-4501_32929aa3-bf4b-45e2-ae61-2a67e14c79d5 50436-4501 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Unit Dose Services DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-4543_42b6b370-b019-4130-b9e8-ceaec37c21f5 50436-4543 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin TABLET, FILM COATED ORAL 19780710 NDA NDA050754 Unit Dose Services AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 50436-4565_0b16af18-1f0f-4d35-93e0-73615c8dbb06 50436-4565 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20110504 ANDA ANDA070791 Unit Dose Services DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 50436-4604_c737ecba-100d-4a47-96db-e0b8445f7ebb 50436-4604 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Unit Dose Services IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-4605_2a8d56bf-ce12-4722-b56e-16af078abd86 50436-4605 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Unit Dose Services IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-4606_9728c910-a6f5-4f23-a3fb-d1bd1d2853bb 50436-4606 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Unit Dose Services IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-4622_6966b092-fbbb-44ba-8f75-39fec5383ed1 50436-4622 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan TABLET ORAL 20090813 ANDA ANDA076554 Unit Dose Services SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 50436-4623_45e1aaa9-fbfe-46a4-a195-4346c321ecd0 50436-4623 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan TABLET ORAL 20090813 ANDA ANDA076554 Unit Dose Services SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 50436-4624_016bafb1-591f-40ee-a1e5-72e698051eac 50436-4624 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Unit Dose Services SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 50436-4628_cbf45a6c-a73a-4e3f-bc2a-627af8b046d0 50436-4628 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 19870803 ANDA ANDA071638 Unit Dose Services TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-4629_64c527ca-3cba-423e-aa5d-ea261984f3a2 50436-4629 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 19870803 ANDA ANDA071638 Unit Dose Services TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-4630_db2e8ade-2862-455a-b23f-bed86480b4ac 50436-4630 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20120628 ANDA ANDA071457 Unit Dose Services TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-4633_7bb03a3e-0b3c-424b-93cf-cb5db99c238a 50436-4633 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19950103 ANDA ANDA074342 Unit Dose Services ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-4634_6eb58cf9-2a81-4972-8c69-d9656929eedf 50436-4634 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Unit Dose Services ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-4635_c62a7198-b3f4-4a5f-b6d5-f92d2f75f714 50436-4635 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Unit Dose Services ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-4636_57e09bd8-0f86-4894-b62a-ec2475aa9db8 50436-4636 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Unit Dose Services ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-4653_2a77dd95-64f5-4a16-be59-11b4ab6558d3 50436-4653 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Unit Dose Services ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 50436-4688_058406c7-915b-492d-90d7-24edc3b5f923 50436-4688 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110120 ANDA ANDA071524 Unit Dose Services TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 50436-4693_a742f678-2885-4f78-a9bc-9ed49144af1d 50436-4693 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Unit Dose Services SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 50436-4694_ad5786f4-84ca-4946-9bda-3c04279ad33b 50436-4694 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Unit Dose Services SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 50436-4715_c7f9a3d1-4709-4d21-9c61-54c2cbc397dd 50436-4715 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110120 ANDA ANDA071523 Unit Dose Services TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 50436-4777_ebad5495-4e4d-4e7b-a2e5-d182f737c616 50436-4777 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 19900930 ANDA ANDA071655 Unit Dose Services OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 50436-4841_84615a9f-7c4c-4a57-97de-c154fe154f78 50436-4841 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20110829 ANDA ANDA078722 Unit Dose Services CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 50436-4842_e8074a3d-6c6e-4133-8067-d4176c8d3020 50436-4842 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 Unit Dose Services CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 50436-4856_12f33220-6250-4b56-8758-94d2c51fbd11 50436-4856 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine TABLET ORAL 19870121 ANDA ANDA089175 Unit Dose Services ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 50436-5000_3f93a79a-d1bc-4a12-aa6d-db5cece353be 50436-5000 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 Unit Dose Services LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50436-5015_59beae10-df09-4f99-8d8c-003007722c25 50436-5015 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19860723 ANDA ANDA089424 Unit Dose Services SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 50436-5022_ffe14de5-f5a8-400f-88b0-eed7ef1ed04c 50436-5022 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 Unit Dose Services CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 50436-5130_2d4eaeee-b9b6-4943-a8fe-b5c02b96e06d 50436-5130 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20050121 ANDA ANDA076673 Unit Dose Services CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 50436-5500_0ab3c14a-f79d-44fa-926d-666148c79ff9 50436-5500 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM ANHYDROUS .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 50436-5501_16626b29-36c7-4fd9-949e-65cbcef62728 50436-5501 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM ANHYDROUS .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 50436-5503_27293535-56c6-42dd-baa4-08e8e8ead721 50436-5503 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM ANHYDROUS .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 50436-5504_0bbb0057-7483-4fce-9ed6-40c95092b51a 50436-5504 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM ANHYDROUS .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 50436-5505_4c8799c6-08f4-465c-96d7-6b25363118e7 50436-5505 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM ANHYDROUS .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 50436-5506_fce15a53-b77a-4928-bddb-7510b4fa6c21 50436-5506 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM ANHYDROUS .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 50436-5537_4fe17d75-8a45-445a-b4e4-bd729a31652e 50436-5537 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Unit Dose Services ESZOPICLONE 1 mg/1 CIV 50436-5538_885daf14-0ebe-48d7-93b8-984e14162b4c 50436-5538 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140414 ANDA ANDA091169 Unit Dose Services ESZOPICLONE 2 mg/1 CIV 50436-5539_885daf14-0ebe-48d7-93b8-984e14162b4c 50436-5539 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140414 ANDA ANDA091169 Unit Dose Services ESZOPICLONE 3 mg/1 CIV 50436-5559_15632a9e-5e16-4974-a73e-a1ee63bc358b 50436-5559 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20100105 ANDA ANDA074118 Unit Dose Services PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-5604_1de28478-959c-40e5-b125-60f6f7f19371 50436-5604 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Unit Dose Services LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50436-5605_fa28de00-a281-4785-8f16-b05ef26a6415 50436-5605 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Unit Dose Services LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50436-5606_1bedcce2-6726-431c-84d1-b891a88031ca 50436-5606 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Unit Dose Services LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50436-5890_c15f644b-745d-43fe-9b6e-a14968da24d7 50436-5890 HUMAN OTC DRUG FERROUS SULFATE IRON SUPPLEMENT TABLET ORAL 20010219 UNAPPROVED DRUG OTHER Unit Dose Services FERROUS SULFATE 325 mg/1 50436-5891_847b2ae7-9473-42f3-bdf4-0aa1d59ceb85 50436-5891 HUMAN OTC DRUG FERROUS SULFATE IRON SUPPLEMENT TABLET ORAL 20010219 UNAPPROVED DRUG OTHER Unit Dose Services FERROUS SULFATE 325 mg/1 50436-5995_4d974a92-bab1-4357-9434-0689ccc52747 50436-5995 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Unit Dose Services BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 50436-5996_1d243b39-5231-4fb4-86b7-270f6f23c9e5 50436-5996 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 Unit Dose Services BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 50436-6041_c69d69a4-b6c1-4733-91df-042f89016cd1 50436-6041 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 Unit Dose Services CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 50436-6046_32f0adb1-e979-4d60-8b6b-b3c49256d446 50436-6046 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Unit Dose Services NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-6050_aa58d675-a818-482e-88be-f2f7236e09ba 50436-6050 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 Unit Dose Services ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 50436-6051_fde3f139-ecc1-4b63-9200-dedbdc8c4c0b 50436-6051 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20111116 ANDA ANDA065101 Unit Dose Services AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 50436-6103_3ad19f2d-97c6-49e6-adf2-1732022dda8a 50436-6103 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Unit Dose Services CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50436-6104_f673453b-0315-4b20-b960-321459a0e6ac 50436-6104 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 19970328 ANDA ANDA074532 Unit Dose Services CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50436-6106_b7391298-c182-4930-a3ad-9a709c05d57b 50436-6106 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Unit Dose Services CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50436-6112_2173475d-167a-493d-aedf-ed19ddf2489a 50436-6112 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20040514 ANDA ANDA076622 Unit Dose Services OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 50436-6124_3b3f1789-1238-4d92-b46d-3a6c09650635 50436-6124 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Unit Dose Services DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 50436-6126_2c551417-a2d1-487c-8a24-dbbba526ff65 50436-6126 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Unit Dose Services DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 50436-6291_b1d26688-4d7c-4cdc-9801-4296563910d7 50436-6291 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Unit Dose Services ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 50436-6301_323f622f-6ffb-4557-af9d-4ef6f40541e8 50436-6301 HUMAN PRESCRIPTION DRUG Bromday bromfenac SOLUTION/ DROPS OPHTHALMIC 20100920 NDA NDA021664 Unit Dose Services BROMFENAC SODIUM .9 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-6302_10eb9c34-01e3-4207-b9f7-54e86f8da98d 50436-6302 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031101 ANDA ANDA076467 Unit Dose Services GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 50436-6304_d72dfdee-c845-4107-8b1c-d19d032538f3 50436-6304 HUMAN PRESCRIPTION DRUG sertraline hydrochloride sertraline hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 Unit Dose Services SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-6305_5746185d-228e-421e-837a-f0e7d3fb8580 50436-6305 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 Unit Dose Services SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-6306_70c438ea-0cbc-48e4-ac08-a42b435f5cec 50436-6306 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 Unit Dose Services SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-6311_aa25091c-6cf0-46d9-94a7-bdb779c1275b 50436-6311 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20001020 ANDA ANDA075536 Unit Dose Services DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 50436-6312_9bbce05b-b3f4-4db2-9754-cc3225c64bda 50436-6312 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20001020 ANDA ANDA075536 Unit Dose Services DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 50436-6334_99b6a5c1-1af6-41a0-af68-cc21476aeeff 50436-6334 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Unit Dose Services NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-6338_895feae0-7de4-40e1-a02d-9e033ab741bc 50436-6338 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Unit Dose Services QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 50436-6339_895feae0-7de4-40e1-a02d-9e033ab741bc 50436-6339 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Unit Dose Services QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 50436-6357_2e2c26d9-d6cb-4ad2-a3b1-13a6d9744f7e 50436-6357 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Unit Dose Services WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 50436-6358_fefc854e-1bbf-42ec-b5ad-c804d3c3be91 50436-6358 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Unit Dose Services WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 50436-6360_c5b33435-07c2-43a0-b42c-d07f0ec59d2e 50436-6360 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Unit Dose Services WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 50436-6363_d4e88480-b64d-4f99-9dd8-a1760aa54aa7 50436-6363 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Unit Dose Services WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 50436-6375_9e19c06a-9a63-41cd-82af-491e94db1376 50436-6375 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA078777 Unit Dose Services ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-6400_a7b096c5-fec0-4dcc-a08e-95885e66c431 50436-6400 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Unit Dose Services LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50436-6408_aff355d8-f86b-4d60-90f3-69f36e906e56 50436-6408 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Unit Dose Services GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 50436-6409_8cb23844-d72b-4931-a476-f054a8ad0aa9 50436-6409 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20110718 ANDA ANDA074388 Unit Dose Services GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 50436-6462_7397c1db-ba47-4b12-b177-d55f513b4755 50436-6462 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Unit Dose Services GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 50436-6463_b9155157-dfd5-42bf-ad6c-b694c5579886 50436-6463 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Unit Dose Services GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 50436-6500_548d4643-0995-49b2-bbec-5341a3f2bd00 50436-6500 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Unit Dose Services LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50436-6523_40f1afc1-d725-48f3-b83a-67c93943d9db 50436-6523 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Unit Dose Services PREGABALIN 75 mg/1 CV 50436-6524_67b778c9-5743-4bf7-ba92-8e20d0b4cb33 50436-6524 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Unit Dose Services PREGABALIN 300 mg/1 CV 50436-6525_8f6ae466-9d9a-4cb0-8d3e-99c9ca747c52 50436-6525 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Unit Dose Services PREGABALIN 25 mg/1 CV 50436-6526_32d2d238-8762-4c2a-9a6d-c6c3539d06dd 50436-6526 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Unit Dose Services PREGABALIN 100 mg/1 CV 50436-6527_0ca848c5-1e47-4d92-983d-6c508d29c758 50436-6527 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Unit Dose Services PREGABALIN 150 mg/1 CV 50436-6528_13ddfb88-a40a-4bff-9e56-eef3b8c1a83e 50436-6528 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Unit Dose Services PREGABALIN 200 mg/1 CV 50436-6540_48580dea-e652-478d-b6f3-899eeece2472 50436-6540 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19981001 ANDA ANDA075034 Unit Dose Services GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 50436-6578_12a1afcf-92a2-4a36-8313-edf57ef9ec3a 50436-6578 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090315 ANDA ANDA078459 Unit Dose Services METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50436-6579_bb2707d1-ff6b-4c29-b352-f32842580ec8 50436-6579 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Unit Dose Services METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50436-6585_16f0ddf1-4ae7-4de8-a0bd-ec4e3b87b381 50436-6585 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Unit Dose Services LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 50436-6590_2ed95593-c937-4f46-9194-80dd4364057f 50436-6590 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 Unit Dose Services NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 50436-6591_002ae94a-fed6-4a4a-aeb4-c62adeb53558 50436-6591 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20070308 ANDA ANDA073652 Unit Dose Services NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 50436-6601_b7c93ff0-b536-4877-9f85-ab076e894c9b 50436-6601 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Unit Dose Services LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50436-6606_428b6935-ea43-4357-b77b-4dd2ec9f7f73 50436-6606 HUMAN OTC DRUG good sense all day pain relief Naproxen Sodium TABLET ORAL 19970114 ANDA ANDA074661 Unit Dose Services NAPROXEN SODIUM 220 mg/1 50436-6607_0abc7f4c-f936-482f-b39b-30dfaafbc4a8 50436-6607 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Unit Dose Services NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-6608_37528994-287f-4ed0-8bfd-e44eb876f12b 50436-6608 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Unit Dose Services NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-6609_11cc7c09-3691-4450-a2b4-d1d87e2834f8 50436-6609 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Unit Dose Services NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-6613_a05e15da-34ef-4121-8fee-268bfda43446 50436-6613 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Unit Dose Services NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-6617_2a645d3c-7887-4f18-84cb-3e32e0c914c0 50436-6617 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Unit Dose Services PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50436-6619_ed3f5acc-08ae-4f6d-aaeb-8f22c8f062b2 50436-6619 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20001020 ANDA ANDA075536 Unit Dose Services DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 50436-6624_c42f76e5-8b77-4d9c-b5e2-95e25199387f 50436-6624 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Unit Dose Services AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50436-6650_6028d1b2-2cf5-4d0d-831a-92e9b6a74d16 50436-6650 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073554 Unit Dose Services NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 50436-6651_9496b814-3f7c-4c5d-b196-af0021cf41ec 50436-6651 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073555 Unit Dose Services NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 50436-6652_e7a205f3-bb66-4c1b-826d-4d34c8f09d81 50436-6652 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073553 Unit Dose Services NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 50436-6660_d808b47d-a5d4-4852-bf46-5eaace64df94 50436-6660 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Unit Dose Services DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 50436-6664_d79fd487-aa10-40ad-afbc-84cf2c475630 50436-6664 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Unit Dose Services LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 50436-6665_365dfb8b-6fce-4455-9082-da787e5266c7 50436-6665 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20101004 ANDA ANDA078385 Unit Dose Services HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 50436-6666_39843703-d554-4245-bc59-4a27b0789dc3 50436-6666 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20100406 ANDA ANDA090528 Unit Dose Services HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 50436-6667_86844701-b015-425a-bf85-c832eff5ed5b 50436-6667 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA090528 Unit Dose Services HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 50436-6668_7661fcfb-90e6-4077-8885-7256481035c8 50436-6668 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Unit Dose Services LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 50436-6669_1f910a85-0c2c-4b29-8d5f-d7ddef934801 50436-6669 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Unit Dose Services LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 50436-6733_ed909bb4-060e-40e8-9b0f-c602be38e7a5 50436-6733 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20080211 ANDA ANDA078391 Unit Dose Services HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 50436-6743_b4fba827-5722-4296-99b5-6406e8a1bf6b 50436-6743 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120815 ANDA ANDA040887 Unit Dose Services PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50436-6744_cf8acf63-bcf5-4b38-97ea-05f12ed958f9 50436-6744 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20050415 ANDA ANDA040555 Unit Dose Services PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50436-6745_671be0ff-6e88-43e3-917b-61100a21ffb0 50436-6745 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040526 Unit Dose Services PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50436-6746_7eb7fa07-594e-47bc-862b-45305a1cff86 50436-6746 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040875 Unit Dose Services PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50436-6752_846d26c3-9e4f-466a-870c-03438e73de47 50436-6752 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 19940511 ANDA ANDA064048 Unit Dose Services GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 50436-6753_2445a7a1-09ca-4a9f-b49f-0870cb5d577e 50436-6753 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET ORAL 20081028 ANDA ANDA078536 Unit Dose Services CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 50436-6755_0fcfc3b4-d346-4d86-9b62-cf35cb6afb88 50436-6755 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Unit Dose Services TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 50436-6756_52ac5fdd-ff5b-43bb-b479-025b25132b29 50436-6756 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Unit Dose Services TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 50436-6810_f25f4eb1-896b-44cc-8979-354be2a296c4 50436-6810 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA073449 Unit Dose Services HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 50436-6858_85dfed9f-a1f7-4932-950f-ef22c8572623 50436-6858 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Unit Dose Services ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 50436-6859_1237cf91-1768-4219-89b6-89291081723a 50436-6859 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Unit Dose Services ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 50436-6914_da761a82-1c77-4067-b91a-14d46d7c1825 50436-6914 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090917 ANDA ANDA078906 Unit Dose Services VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 50436-6915_30b4c9ca-4490-402a-9d76-5ca96e4e0c1e 50436-6915 HUMAN PRESCRIPTION DRUG Verapamil Verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121119 ANDA ANDA200878 Unit Dose Services VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 50436-6916_c881b848-c30e-453f-a8b8-fe3ff2b20570 50436-6916 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA090700 Unit Dose Services VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 50436-6924_659c515b-d05a-4e45-a88d-94a0d28b018e 50436-6924 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Unit Dose Services DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-6925_b0646433-050a-43c3-a67a-e8be851c3c2b 50436-6925 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Extended-Release Diclofenac Sodium TABLET, EXTENDED RELEASE ORAL 20020107 ANDA ANDA075910 Unit Dose Services DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-6930_97fea67c-532f-4ac9-8cba-df31ba858fe7 50436-6930 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Unit Dose Services RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 50436-6942_be5e2d6f-b6d9-4134-9f4d-de9f87ca93cb 50436-6942 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Unit Dose Services RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 50436-6951_c2ae80cf-143d-4364-adea-2f7c6fd57d8c 50436-6951 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20070609 ANDA ANDA077309 Unit Dose Services ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 50436-7000_6373bbec-c0d3-416a-97bc-c27b0df6850a 50436-7000 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20061004 ANDA ANDA077912 Unit Dose Services HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50436-7053_3802ae77-c34f-4be8-9e4b-829054302a6a 50436-7053 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Unit Dose Services METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50436-7054_19f16383-d4e7-4f79-a181-64fe54e17204 50436-7054 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Unit Dose Services METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50436-7056_f8c5fb16-a7df-440b-aeaf-f17971ffb6e6 50436-7056 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Unit Dose Services METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50436-7066_98f9c54f-5f56-40eb-8a52-ac1d27645abe 50436-7066 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20010327 ANDA ANDA040411 Unit Dose Services METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 50436-7067_0c816261-3fe2-4652-916b-ebb26709e774 50436-7067 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Unit Dose Services CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 50436-7073_d74396ee-8e84-4a80-ae7f-cc6eb5ba2413 50436-7073 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Unit Dose Services GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 50436-7074_31d31adf-5fa1-409b-aea3-2482a5c6c936 50436-7074 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Unit Dose Services GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 50436-7075_0c7be21f-8e18-4c11-bc0c-24d86784fa95 50436-7075 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Unit Dose Services GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 50436-7076_d1cdbb7a-4ec4-441c-9b4a-c0dffc4de42f 50436-7076 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Unit Dose Services AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 50436-7216_e658080f-3de4-412a-b5fd-a21f909475aa 50436-7216 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Unit Dose Services CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 50436-7218_89dbcc13-a496-4118-804d-902870124b46 50436-7218 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20070301 ANDA ANDA065291 Unit Dose Services AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 50436-7284_2f77b684-b696-4166-beef-c0ffed92504e 50436-7284 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Unit Dose Services GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50436-7285_aa80e864-f947-41cf-b721-33166970bc0e 50436-7285 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Unit Dose Services GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50436-7286_2d2590ad-8497-4406-8178-87e6cd877cc5 50436-7286 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20080801 ANDA ANDA076017 Unit Dose Services GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50436-7350_8f94ac28-2b41-4b03-8d08-4e896e92a179 50436-7350 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091111 ANDA ANDA077255 Unit Dose Services LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 50436-7370_dcead2cf-1a5a-4583-a646-16194c9f3965 50436-7370 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Unit Dose Services FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 50436-7371_ffe378ab-d91d-4907-b216-12979d52b3d4 50436-7371 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Unit Dose Services FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 50436-7376_8c5a54d1-bd63-41eb-b155-4d29d6a38fd1 50436-7376 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Unit Dose Services HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 50436-7379_477836ad-b0ed-4330-a91a-48ab624a2f54 50436-7379 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Unit Dose Services HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 50436-7382_43fa5b3a-61aa-44c3-8c3e-a165d6108bcb 50436-7382 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20100420 ANDA ANDA074754 Unit Dose Services KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-7392_73074e65-e6e6-44a9-a959-7cf0a5c62268 50436-7392 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 19950109 ANDA ANDA062535 Unit Dose Services TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 50436-7601_e079bf81-c920-4fbe-abc1-8c1307123141 50436-7601 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Unit Dose Services ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 50436-7602_159b012f-e14c-443d-95a3-4a2425d5400e 50436-7602 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Unit Dose Services CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-7801_3fd8b7fe-957e-48bb-acf2-f545940394fe 50436-7801 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Unit Dose Services CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-7988_d181c9d1-83c0-4c2a-9898-052bfaecbc90 50436-7988 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Unit Dose Services LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50436-8000_fa9c7bc1-9afc-4342-a258-0798a7a46f2b 50436-8000 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060410 ANDA ANDA077912 Unit Dose Services HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50436-8101_c7dec2ac-dd67-41ce-bd13-eba69a41eaf8 50436-8101 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20070910 ANDA ANDA077058 Unit Dose Services PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 50436-8102_35cd24c7-0159-4ad2-8c04-7d94375120fb 50436-8102 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA091231 Unit Dose Services PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 50436-8700_9d8bed28-4c34-4ce7-9311-ad8f5194ab30 50436-8700 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 Unit Dose Services LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50436-8787_23e56c82-db49-49ab-b04b-4eb864b9aaa8 50436-8787 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 Unit Dose Services TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 50436-8788_6305c108-8a53-4989-a00d-ea8aa5fcb66d 50436-8788 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111230 ANDA ANDA091607 Unit Dose Services TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 50436-8900_e930d6e6-4693-4ecd-8611-824a2d770a17 50436-8900 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060410 ANDA ANDA077912 Unit Dose Services HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50436-9022_50db8f45-4db0-450c-8130-ae1dbbbfdcf7 50436-9022 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072234 Unit Dose Services BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 50436-9023_a84ca838-067e-46ee-b03c-63a133ed338c 50436-9023 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100715 ANDA ANDA072235 Unit Dose Services BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 50436-9028_29d17b50-2580-4f90-a5ad-afef9b071f04 50436-9028 HUMAN PRESCRIPTION DRUG phentermine hydrochloride phentermine hydrochloride CAPSULE ORAL 19810612 ANDA ANDA087190 Unit Dose Services PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50436-9029_d1244ccb-aa69-49a5-824b-1b3df9b016ce 50436-9029 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 Unit Dose Services PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 50436-9036_b5b855be-c250-4a25-93a6-55a6f94abb81 50436-9036 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 19940601 ANDA ANDA074224 Unit Dose Services TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 50436-9054_e6e906e0-9261-46c4-ab74-24defb5404b5 50436-9054 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Unit Dose Services METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 50436-9055_932112e8-06fe-4f40-b581-6fb2ef3981c8 50436-9055 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Unit Dose Services METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 50436-9056_b6236466-10cd-4189-8135-d202d469bb74 50436-9056 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Unit Dose Services METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 50436-9071_efb3d059-ae8d-4c83-a780-e1bbd093c09c 50436-9071 HUMAN PRESCRIPTION DRUG TRANZGEL ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM GEL TRANSDERMAL 20100701 UNAPPROVED HOMEOPATHIC Unit Dose Services ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL 1; 3; 3; 3; 1; 1; 1; 3; 4; 1; 1; 1; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 50436-9072_3f0b70f2-9126-4334-892c-f9bb207ca107 50436-9072 HUMAN PRESCRIPTION DRUG SPEEDGEL RX ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE GEL TRANSDERMAL 20111201 UNAPPROVED HOMEOPATHIC Unit Dose Services ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL 1; 3; 1; 3; 1; 1; 1; 3; 3; 1; 1; 1; 1; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 50436-9074_2650faf8-b415-4119-8aba-b7aaf4aeaaf6 50436-9074 HUMAN PRESCRIPTION DRUG SPEEDGEL RX ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE GEL TRANSDERMAL 20111201 UNAPPROVED HOMEOPATHIC Unit Dose Services ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM OIL 1; 3; 1; 3; 1; 1; 1; 3; 3; 1; 1; 1; 1; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 50436-9101_ed927a26-b78e-429a-ad02-f08cd2868cf4 50436-9101 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20100426 ANDA ANDA075584 Unit Dose Services BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 50436-9102_b014f9e9-3e45-4cdd-ab35-468062005104 50436-9102 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 Unit Dose Services BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 50436-9103_d90d6916-0d38-40c8-a0ba-4a4a12ce3d43 50436-9103 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100331 ANDA ANDA077285 Unit Dose Services BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 50436-9787_62a1075b-e85f-4fb8-8fd0-ea51d3306dca 50436-9787 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Unit Dose Services MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 50436-9802_6d2a0a66-d3d7-4892-a40a-c3b11fed9176 50436-9802 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 Unit Dose Services CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 50436-9803_26ebbf11-8b51-4099-b7ee-e52b9bd3b4a5 50436-9803 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Unit Dose Services ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-9933_88d82b51-9062-4e7c-a369-4e56217da483 50436-9933 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Unit Dose Services WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 50436-9946_fde8e330-e3ac-4053-949d-652edd69c6b1 50436-9946 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Unit Dose Services WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 50436-9949_ebe6e060-2594-4125-9e82-5fa31f09b0e4 50436-9949 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Unit Dose Services TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50436-9950_c7233a6c-7548-41f2-8eea-84916054a8c0 50436-9950 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Unit Dose Services TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50436-9951_a4e8b126-0eb6-400b-a960-6a9af496fd4e 50436-9951 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Unit Dose Services TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50436-9952_93d73dee-75c7-4739-bd76-8427af855605 50436-9952 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Unit Dose Services TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50436-9971_7013230e-55f4-48af-926b-9aa542ea09ba 50436-9971 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080624 ANDA ANDA077470 Unit Dose Services RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 50436-9972_e95b8511-d38e-4444-8e95-7afcd2129d6b 50436-9972 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20071001 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM ANHYDROUS .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 50436-9973_6dabbb3f-3fac-43b8-a8d9-c65340ccf91c 50436-9973 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET ORAL 19860723 ANDA ANDA089424 Unit Dose Services SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 50436-9974_c3e78cbd-4790-4ffa-9ad5-bd21663e45ed 50436-9974 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA090425 Unit Dose Services DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 50436-9975_482cb0f4-88a0-4f5e-8b72-1fb0eb3337ce 50436-9975 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA090425 Unit Dose Services DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 50436-9976_e0493397-04a9-4d24-a7d3-18a94f21048d 50436-9976 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078790 Unit Dose Services DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 50436-9978_fba44bcd-2967-4fe5-9cbd-79d19752a2ac 50436-9978 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Unit Dose Services ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 50436-9979_2614d82d-3649-45c1-a518-ae89cff840c2 50436-9979 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Unit Dose Services DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-9980_18b2db7f-79f9-46c5-94be-e3c7c33b751d 50436-9980 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Unit Dose Services DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-9982_8dfe362e-aab9-4fc9-a04e-aa1345a73060 50436-9982 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20100115 NDA NDA021427 Unit Dose Services DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-9983_7cb80ebb-1c46-486c-99bb-7bacfe6694e0 50436-9983 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Unit Dose Services ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50436-9985_04e62cb4-8378-4cee-ad89-92cf5af56a75 50436-9985 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate CREAM TOPICAL 19960930 ANDA ANDA074392 Unit Dose Services CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50436-9986_ef8542f5-5619-45d9-8548-968f11203604 50436-9986 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA090540 Unit Dose Services CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 50436-9987_20842365-3ea6-4e1a-8139-aae4e4f82eea 50436-9987 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Unit Dose Services ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50436-9988_fb944494-2299-4985-8ce6-825d4981556a 50436-9988 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Unit Dose Services ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50436-9989_4b32f5d8-69a3-4860-a0ac-807004eff5bc 50436-9989 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Unit Dose Services ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50436-9990_56985f25-b3d8-455a-bcd9-9584f6415779 50436-9990 HUMAN OTC DRUG Topical Pain Relief Methyl Salicylate, Menthol, capsaicin CREAM TOPICAL 20110115 OTC MONOGRAPH NOT FINAL part348 Unit Dose Services CAPSAICIN; MENTHOL; METHYL SALICYLATE .0355; 5; 20 g/100g; g/100g; g/100g 50436-9991_48c078c9-bafb-4648-9610-ec3a0eec2b7f 50436-9991 HUMAN OTC DRUG MEDROX MENTHOL, CAPSAICIN PATCH TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part348 Unit Dose Services CAPSAICIN; MENTHOL .0375; 5 g/100g; g/100g 50436-9992_d307b7fb-c019-4499-b650-ec7a5452567f 50436-9992 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20080116 ANDA ANDA077570 Unit Dose Services FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50436-9993_59eaccd4-d8ed-4c49-8452-005a8a6818f3 50436-9993 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Unit Dose Services MILNACIPRAN HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 50436-9994_a5301358-a8cd-436a-abb5-0494b1e5f15c 50436-9994 HUMAN OTC DRUG Medrox METHYL SALICYLATE, MENTHOL, CAPSAICIN OINTMENT TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part348 Unit Dose Services CAPSAICIN; MENTHOL; METHYL SALICYLATE .0375; 5; 20 g/100g; g/100g; g/100g 50436-9995_08c55b04-4e94-4866-9e22-46f116b2eb52 50436-9995 HUMAN OTC DRUG Terocin Methyl Salicylate, Capsaicin, Menthol and Lidocaine Hydrochloride LOTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part348 Unit Dose Services CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE .025; 2.5; 10; 25 g/100mL; g/100mL; g/100mL; g/100mL 50436-9996_07fa3356-db7c-41a4-9afb-972168b443de 50436-9996 HUMAN OTC DRUG New Terocin Methyl Salicylate, Capsaicin, and Menthol LOTION TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part348 Unit Dose Services CAPSAICIN; MENTHOL; METHYL SALICYLATE .025; 10; 25 g/100mL; g/100mL; g/100mL 50438-000_59010069-606b-4b93-b56e-653c6eae3a27 50438-000 HUMAN OTC DRUG ROYAL ALCOHOL CLEANSING PADS ISOPROPYL ALCOHOL LIQUID TOPICAL 20130729 OTC MONOGRAPH NOT FINAL part333A Filo America ISOPROPYL ALCOHOL .45 mg/g 50438-001_61c73a37-7089-4062-8a0b-cf4647dc1765 50438-001 HUMAN OTC DRUG ROYAL Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL 20141029 OTC MONOGRAPH NOT FINAL part334 Filo America MAGNESIUM SULFATE 1 kg/kg 50438-100_56cdf7a1-8490-47d5-bf58-d400f2ac9eda 50438-100 HUMAN OTC DRUG Virx Instant Hand Sanitizer with moisturizers and Vitamin E ALCOHOL GEL TOPICAL 20130730 OTC MONOGRAPH NOT FINAL part333E Filo America ALCOHOL 62 mL/100mL 50438-101_c6a8b618-d4a4-4c20-9a83-1ac6d9dc5d07 50438-101 HUMAN OTC DRUG Pacific Anti-bacterial Hand Cleanse Kiwi Essence Triclosan GEL TOPICAL 20130808 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL 50438-102_515c193f-3aae-4fd0-b905-584e18c1ee79 50438-102 HUMAN OTC DRUG Pacific Anti-bacterial Hand Cleanse Blueberry Essence Triclosan GEL TOPICAL 20130808 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL 50438-103_8d196a15-6dd5-4079-9235-a86f89dcb576 50438-103 HUMAN OTC DRUG Pacific Anti-bacterial Hand Cleanse Peach Essence Triclosan GEL TOPICAL 20130808 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL 50438-104_1c5da675-5a4b-4c81-8977-6ecf24fe403a 50438-104 HUMAN OTC DRUG Pacific Anti-bacterial Hand Cleanse Strawberry Essence Triclosan GEL TOPICAL 20130808 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL 50438-105_0c57dc16-b5f4-4cbe-82a4-77d3fa9798f8 50438-105 HUMAN OTC DRUG Royal Antibacterial Orange Berry Hand Cleanse Triclosan GEL TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL 50438-106_dc31d249-4359-4cc3-abec-ab59ccef7378 50438-106 HUMAN OTC DRUG Royal Antibacterial Raspberry Hand Cleanse Triclosan GEL TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL 50438-107_5ca9d71b-5e14-4d97-a492-a1d1e8ca1cf0 50438-107 HUMAN OTC DRUG Royal Antibacterial Passion Plum Hand Cleanse Triclosan GEL TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL 50438-108_701409ce-fddc-4257-baeb-e18939be1d55 50438-108 HUMAN OTC DRUG Royal Antibacterial Tropical Fruit Hand Cleanse Triclosan GEL TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL 50438-128_19e6c55a-4b14-4215-aa0a-a576b62b6968 50438-128 HUMAN OTC DRUG ANTIBACTERIAL BANDAGE benzalkonium chloride SWAB TOPICAL 20130816 OTC MONOGRAPH NOT FINAL part333A Filo America BENZALKONIUM CHLORIDE .12 g/100g 50438-200_5bd06cd2-6ea1-4c7a-bde2-d5d35f66b17f 50438-200 HUMAN OTC DRUG Virx Instant Hand Sanitizer with security clip ALCOHOL GEL TOPICAL 20130730 OTC MONOGRAPH NOT FINAL part333E Filo America ALCOHOL 62 mL/100mL 50438-210_3b5edd70-a846-426a-ab44-018dc701f11e 50438-210 HUMAN OTC DRUG Oil-Free Acne Wash Salicylic Acid LOTION TOPICAL 20080608 OTC MONOGRAPH FINAL part333D Filo America SALICYLIC ACID 20 mg/mL 50438-300_f132d80e-721f-4219-963e-43764aaa88bf 50438-300 HUMAN OTC DRUG Royal dandruff Dry Scalp Care PYRITHIONE ZINC SHAMPOO TOPICAL 20130917 OTC MONOGRAPH FINAL part358H Filo America PYRITHIONE ZINC 1 g/100mL 50438-301_d78c001d-7e3a-42a3-ac31-708dabae6ac4 50438-301 HUMAN OTC DRUG Green MINT Mouth Rinse EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130730 OTC MONOGRAPH NOT FINAL part356 Filo America EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 50438-302_20145361-4fa7-45bf-a640-fdcc214c0269 50438-302 HUMAN OTC DRUG Peppermint Mouth Rinse EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130730 OTC MONOGRAPH NOT FINAL part356 Filo America EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 50438-303_3e53869c-ea36-4599-849f-ff629a1be9b7 50438-303 HUMAN OTC DRUG Amber Mouth Rinse EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130730 OTC MONOGRAPH NOT FINAL part356 Filo America EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 50438-304_1dd6b65e-11df-4ec2-93af-70888a53b1b1 50438-304 HUMAN OTC DRUG Royal Mouthwash Fresh and Clean Original Mint EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130917 OTC MONOGRAPH NOT FINAL part356 Filo America EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 50438-400_c3d4fca4-d621-465a-b3a9-f0bef5779d40 50438-400 HUMAN OTC DRUG Royal Petroleum (Cocoa Scent) PETROLATUM JELLY TOPICAL 20140219 OTC MONOGRAPH FINAL part347 Filo America PETROLATUM 30 g/100g 50438-401_bee0a22f-1615-45d0-bbf5-f30c48b0fe62 50438-401 HUMAN OTC DRUG Royal Petroleum (Vitamin E Enriched) PETROLATUM JELLY TOPICAL 20140219 OTC MONOGRAPH FINAL part347 Filo America PETROLATUM 30 g/100g 50438-807_e8c7b337-38d8-4848-b296-7673e5a987e8 50438-807 HUMAN OTC DRUG Virx Instant Hand Sanitizer GEL TOPICAL 20100211 OTC MONOGRAPH FINAL part333 Filo America ALCOHOL 496 mL/800mL 50441-0001_c8c66c66-0932-4b32-8b8b-80f0972424ca 50441-0001 HUMAN OTC DRUG PainDefense Actaea spicata, Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Causticum, Cimicifuga racemosa, Formicum acidum, Hypericum perforatum, Lemna minor, Lithium carbonicum, Magnesia phosphorica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhododendron chrysanthum, Rhus toxicodendron, Ruta graveolens, Salicylicum acidum, Sepia, Zincum metallicum LIQUID ORAL 20130806 UNAPPROVED HOMEOPATHIC PharmWest Inc. ACTAEA SPICATA ROOT; ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAUSTICUM; FORMIC ACID; HORSE CHESTNUT; HYPERICUM PERFORATUM; LEMNA MINOR; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 50441-0002_7cdc345d-b78e-41dd-8d9d-7294f40f2966 50441-0002 HUMAN OTC DRUG Allergy and Hay Fever Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Arum triphyllum, Arundo mauritanica, Euphrasia officinalis, Naphthalinum, Natrum muriaticum, Sabadilla, Wyethia helenioides LIQUID ORAL 20121108 UNAPPROVED HOMEOPATHIC PharmWest Inc. AMBROSIA ARTEMISIIFOLIA; ARISAEMA TRIPHYLLUM ROOT; ARSENIC TRIOXIDE; ARUNDO PLINIANA ROOT; EUPHRASIA STRICTA; NAPHTHALENE; ONION; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; WYETHIA HELENIOIDES ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 50441-0003_9c4ad935-0db7-4c92-9059-42b8a4c98ee0 50441-0003 HUMAN OTC DRUG Sinus Relief Apis mellifica, Baptisia tinctoria, Colocynthis, Hepar sulphuris calcareum, Histaminum hydrochloricum, Hydrastis canadensis, Ignatia amara, Kali bichromicum, Lemna minor, Mercurius vivus, Pulsatilla, Rhus toxicodendron, Sabadilla, Thuja occidentalis LIQUID ORAL 20131121 UNAPPROVED HOMEOPATHIC PharmWest Inc. APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; CITRULLUS COLOCYNTHIS FRUIT PULP; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; LEMNA MINOR; MERCURY; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; STRYCHNOS IGNATII SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 50441-0005_6d73454f-5078-4de4-be5d-c6a6a2c48138 50441-0005 HUMAN OTC DRUG Cold and Flu Relief Aconitum napellus, Arsenicum album, Baptisia tinctoria, Bryonia, Causticum, Cinchona officinalis, Echinacea purpurea, Eucalyptus globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Influenzinum, Phytolacca decandra, Rhus toxicodendron, Sarcolacticum acidum, Sulphur, Wyethia helenioides, Zincum aceticum, Zincum muriaticum, Zincum oxydatum LIQUID ORAL 20131121 UNAPPROVED HOMEOPATHIC PharmWest Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LACTIC ACID, L-; PHYTOLACCA AMERICANA ROOT; SULFUR; TOXICODENDRON PUBESCENS LEAF; WYETHIA HELENIOIDES ROOT; ZINC ACETATE ANHYDROUS; ZINC CHLORIDE; ZINC OXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 50452-221_6587cd4a-676b-4a03-b5ad-14006c19a37c 50452-221 HUMAN OTC DRUG Pure Gel ALCOHOL GEL TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333 Phoenix Research Industries, Inc. ALCOHOL .7 mL/mL 50452-773_167bec9c-75c6-43ad-978b-b5862e435a7b 50452-773 HUMAN OTC DRUG Pure Foam ALCOHOL AEROSOL, FOAM TOPICAL 20100131 OTC MONOGRAPH NOT FINAL part333 Phoenix Research Industries, Inc. ALCOHOL 620 mg/g 50458-090_2bc2e727-49cc-43be-9a75-113637bf07c8 50458-090 HUMAN PRESCRIPTION DRUG DURAGESIC fentanyl PATCH TRANSDERMAL 19900807 NDA NDA019813 Janssen Pharmaceuticals, Inc. FENTANYL 12.5 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 50458-091_2bc2e727-49cc-43be-9a75-113637bf07c8 50458-091 HUMAN PRESCRIPTION DRUG DURAGESIC fentanyl PATCH TRANSDERMAL 19900807 NDA NDA019813 Janssen Pharmaceuticals, Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 50458-092_2bc2e727-49cc-43be-9a75-113637bf07c8 50458-092 HUMAN PRESCRIPTION DRUG DURAGESIC fentanyl PATCH TRANSDERMAL 19900807 NDA NDA019813 Janssen Pharmaceuticals, Inc. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 50458-093_2bc2e727-49cc-43be-9a75-113637bf07c8 50458-093 HUMAN PRESCRIPTION DRUG DURAGESIC fentanyl PATCH TRANSDERMAL 19900807 NDA NDA019813 Janssen Pharmaceuticals, Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 50458-094_2bc2e727-49cc-43be-9a75-113637bf07c8 50458-094 HUMAN PRESCRIPTION DRUG DURAGESIC fentanyl PATCH TRANSDERMAL 19900807 NDA NDA019813 Janssen Pharmaceuticals, Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 50458-098_e8990260-1275-11e2-a6a1-c7c56188709b 50458-098 HUMAN PRESCRIPTION DRUG ELMIRON PENTOSAN POLYSULFATE SODIUM CAPSULE, GELATIN COATED ORAL 19960926 NDA NDA020193 Janssen Pharmaceuticals, Inc. PENTOSAN POLYSULFATE SODIUM 100 mg/1 Glycosaminoglycan [EPC],Glycosaminoglycans [Chemical/Ingredient] 50458-140_43a115d4-46a5-4515-b47e-fc0fb546302a 50458-140 HUMAN PRESCRIPTION DRUG INVOKANA canagliflozin TABLET, FILM COATED ORAL 20130329 NDA NDA204042 Janssen Pharmaceuticals, Inc. CANAGLIFLOZIN 100 mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA] 50458-141_43a115d4-46a5-4515-b47e-fc0fb546302a 50458-141 HUMAN PRESCRIPTION DRUG INVOKANA canagliflozin TABLET, FILM COATED ORAL 20130329 NDA NDA204042 Janssen Pharmaceuticals, Inc. CANAGLIFLOZIN 300 mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA] 50458-166_fda74acc-68e3-4d33-8738-bda052471a4d 50458-166 HUMAN PRESCRIPTION DRUG Levaquin levofloxacin INJECTION, SOLUTION INTRAVENOUS 19961220 NDA NDA020635 Janssen Pharmaceuticals, Inc. LEVOFLOXACIN 5 mg/mL 50458-167_fda74acc-68e3-4d33-8738-bda052471a4d 50458-167 HUMAN PRESCRIPTION DRUG Levaquin levofloxacin INJECTION, SOLUTION INTRAVENOUS 19961220 NDA NDA020635 Janssen Pharmaceuticals, Inc. LEVOFLOXACIN 5 mg/mL 50458-168_fda74acc-68e3-4d33-8738-bda052471a4d 50458-168 HUMAN PRESCRIPTION DRUG Levaquin levofloxacin INJECTION, SOLUTION INTRAVENOUS 19961220 NDA NDA020635 Janssen Pharmaceuticals, Inc. LEVOFLOXACIN 5 mg/mL 50458-170_fda74acc-68e3-4d33-8738-bda052471a4d 50458-170 HUMAN PRESCRIPTION DRUG Levaquin levofloxacin SOLUTION ORAL 20041021 NDA NDA021721 Janssen Pharmaceuticals, Inc. LEVOFLOXACIN 25 mg/mL 50458-171_b1bb6730-fc09-4ea7-8c26-ec00827ee63a 50458-171 HUMAN PRESCRIPTION DRUG Modicon norethindrone and ethinyl estradiol KIT 19840404 NDA NDA018985 Janssen Pharmaceuticals, Inc. 50458-176_b1bb6730-fc09-4ea7-8c26-ec00827ee63a 50458-176 HUMAN PRESCRIPTION DRUG Ortho Novum 135 norethindrone and ethinyl estradiol KIT 19770623 NDA NDA017919 Janssen Pharmaceuticals, Inc. 50458-178_b1bb6730-fc09-4ea7-8c26-ec00827ee63a 50458-178 HUMAN PRESCRIPTION DRUG Ortho-Novum 777 norethindrone and ethinyl estradiol KIT 19840404 NDA NDA018985 Janssen Pharmaceuticals, Inc. 50458-191_1fc62541-2f2b-456b-8816-250bc8be36c1 50458-191 HUMAN PRESCRIPTION DRUG Ortho Tri Cyclen norgestimate and ethinyl estradiol KIT 19891229 NDA NDA019653 Janssen Pharmaceuticals, Inc. 50458-192_26b132a9-b2f0-44fe-8f4d-db966ceb193a 50458-192 HUMAN PRESCRIPTION DRUG Ortho Evra norelgestromin and ethinyl estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 20011120 NDA NDA021180 Janssen Pharmaceutical, Inc. ETHINYL ESTRADIOL; NORELGESTROMIN 35; 150 ug/d; ug/d Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 50458-194_41e174eb-607c-46a4-a8c2-6fabee32c248 50458-194 HUMAN PRESCRIPTION DRUG Ortho Micronor NORETHINDRONE TABLET ORAL 19730102 NDA NDA016954 Janssen Pharmaceuticals, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 50458-196_61a352e3-b8c9-40c5-8322-124d919c30c5 50458-196 HUMAN PRESCRIPTION DRUG Ortho Cept desogestrel and ethinyl estradiol KIT 19921214 NDA NDA020301 Janssen Pharmaceuticals, Inc. 50458-197_1fc62541-2f2b-456b-8816-250bc8be36c1 50458-197 HUMAN PRESCRIPTION DRUG Ortho Cyclen norgestimate and ethinyl estradiol KIT 19891229 NDA NDA019653 Janssen Pharmaceuticals, Inc. 50458-210_26f52d23-5e1a-4361-9e35-7581b886dbf1 50458-210 HUMAN PRESCRIPTION DRUG AXERT almotriptan malate TABLET, COATED ORAL 20010507 NDA NDA021001 Janssen Pharmaceuticals, Inc. ALMOTRIPTAN MALATE 12.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 50458-211_26f52d23-5e1a-4361-9e35-7581b886dbf1 50458-211 HUMAN PRESCRIPTION DRUG AXERT almotriptan malate TABLET, COATED ORAL 20010507 NDA NDA021001 Janssen Pharmaceuticals, Inc. ALMOTRIPTAN MALATE 6.25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 50458-220_895d2672-26d8-4b41-9165-fae35259143d 50458-220 HUMAN PRESCRIPTION DRUG Nizoral Ketoconazole TABLET ORAL 19810612 NDA NDA018533 Janssen Pharmaceuticals, Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 50458-251_6d1d0c48-167d-4254-8bb2-6e0ca41aa78c 50458-251 HUMAN PRESCRIPTION DRUG ORTHO TRI CYCLEN Lo norgestimate and ethinyl estradiol KIT 20020822 NDA NDA021241 Janssen Pharmaceuticals, Inc. 50458-253_d4658be0-e12f-4082-9c2a-b5a9a298578a 50458-253 HUMAN PRESCRIPTION DRUG Haldol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 19860114 NDA NDA018701 Janssen Pharmaceuticals, Inc. HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] 50458-254_d4658be0-e12f-4082-9c2a-b5a9a298578a 50458-254 HUMAN PRESCRIPTION DRUG Haldol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 19860114 NDA NDA018701 Janssen Pharmaceuticals, Inc. HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] 50458-255_8483b9ac-1bc5-46fb-9cb9-6047d7c62a5b 50458-255 HUMAN PRESCRIPTION DRUG Haldol Haloperidol INJECTION INTRAMUSCULAR 19710518 NDA NDA015923 Janssen Pharmaceuticals, Inc. HALOPERIDOL 5 mg/mL Typical Antipsychotic [EPC] 50458-290_572e7cb3-dcdf-427e-ab19-a2edddd68dba 50458-290 HUMAN PRESCRIPTION DRUG SPORANOX ITRACONAZOLE CAPSULE ORAL 19920911 NDA NDA020083 Janssen Pharmaceuticals, Inc. ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 50458-295_1c411659-2c81-41d6-a341-5abb6e20948b 50458-295 HUMAN PRESCRIPTION DRUG SPORANOX itraconazole SOLUTION ORAL 19970221 NDA NDA020657 Janssen Pharmaceuticals, Inc. ITRACONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 50458-300_d2ad74ae-feb2-4ece-8a29-dc234867afe2 50458-300 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceuticals, Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 50458-301_d2ad74ae-feb2-4ece-8a29-dc234867afe2 50458-301 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceuticals, Inc. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 50458-302_d2ad74ae-feb2-4ece-8a29-dc234867afe2 50458-302 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceuticals, Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 50458-305_d2ad74ae-feb2-4ece-8a29-dc234867afe2 50458-305 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone SOLUTION ORAL 19960610 NDA NDA020588 Janssen Pharmaceuticals, Inc. RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] 50458-306_88360b79-e36b-4d4f-aafe-8cb70c1f4624 50458-306 HUMAN PRESCRIPTION DRUG RISPERDAL CONSTA risperidone KIT 20031029 NDA NDA021346 Janssen Pharmaceuticals, Inc. 50458-307_88360b79-e36b-4d4f-aafe-8cb70c1f4624 50458-307 HUMAN PRESCRIPTION DRUG RISPERDAL CONSTA risperidone KIT 20031029 NDA NDA021346 Janssen Pharmaceuticals, Inc. 50458-308_88360b79-e36b-4d4f-aafe-8cb70c1f4624 50458-308 HUMAN PRESCRIPTION DRUG RISPERDAL CONSTA risperidone KIT 20031029 NDA NDA021346 Janssen Pharmaceuticals, Inc. 50458-309_88360b79-e36b-4d4f-aafe-8cb70c1f4624 50458-309 HUMAN PRESCRIPTION DRUG RISPERDAL CONSTA risperidone KIT 20031029 NDA NDA021346 Janssen Pharmaceuticals, Inc. 50458-315_d2ad74ae-feb2-4ece-8a29-dc234867afe2 50458-315 HUMAN PRESCRIPTION DRUG RISPERDAL M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceuticals, Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 50458-320_d2ad74ae-feb2-4ece-8a29-dc234867afe2 50458-320 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceuticals, Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 50458-325_d2ad74ae-feb2-4ece-8a29-dc234867afe2 50458-325 HUMAN PRESCRIPTION DRUG RISPERDAL M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceuticals, Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 50458-330_d2ad74ae-feb2-4ece-8a29-dc234867afe2 50458-330 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceuticals, Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 50458-335_d2ad74ae-feb2-4ece-8a29-dc234867afe2 50458-335 HUMAN PRESCRIPTION DRUG RISPERDAL M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceuticals, Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 50458-341_cf82bfd4-8650-44ed-abee-fe7e3cc4ab3c 50458-341 HUMAN PRESCRIPTION DRUG PANCREAZE PANCRELIPASE CAPSULE, DELAYED RELEASE ORAL 20100412 NDA NDA022523 Janssen Pharmaceuticals, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 17500; 4200; 10000 [USP'U]/1; [USP'U]/1; [USP'U]/1 50458-342_cf82bfd4-8650-44ed-abee-fe7e3cc4ab3c 50458-342 HUMAN PRESCRIPTION DRUG PANCREAZE PANCRELIPASE CAPSULE, DELAYED RELEASE ORAL 20100412 NDA NDA022523 Janssen Pharmaceuticals, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 43750; 10500; 25000 [USP'U]/1; [USP'U]/1; [USP'U]/1 50458-343_cf82bfd4-8650-44ed-abee-fe7e3cc4ab3c 50458-343 HUMAN PRESCRIPTION DRUG PANCREAZE PANCRELIPASE CAPSULE, DELAYED RELEASE ORAL 20100412 NDA NDA022523 Janssen Pharmaceuticals, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 70000; 16800; 40000 [USP'U]/1; [USP'U]/1; [USP'U]/1 50458-346_cf82bfd4-8650-44ed-abee-fe7e3cc4ab3c 50458-346 HUMAN PRESCRIPTION DRUG PANCREAZE PANCRELIPASE CAPSULE, DELAYED RELEASE ORAL 20100412 NDA NDA022523 Janssen Pharmaceuticals, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 61000; 21000; 37000 [USP'U]/1; [USP'U]/1; [USP'U]/1 50458-350_d2ad74ae-feb2-4ece-8a29-dc234867afe2 50458-350 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceuticals, Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 50458-355_d2ad74ae-feb2-4ece-8a29-dc234867afe2 50458-355 HUMAN PRESCRIPTION DRUG RISPERDAL M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceuticals, Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 50458-387_d55c25ea-dc75-42f0-bd2f-5370374c1db0 50458-387 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20041224 NDA NDA021615 Janssen Pharmaceuticals, Inc. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 50458-388_d55c25ea-dc75-42f0-bd2f-5370374c1db0 50458-388 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20041224 NDA NDA021615 Janssen Pharmaceuticals, Inc. GALANTAMINE HYDROBROMIDE 16 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 50458-389_d55c25ea-dc75-42f0-bd2f-5370374c1db0 50458-389 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20041224 NDA NDA021615 Janssen Pharmaceuticals, Inc. GALANTAMINE HYDROBROMIDE 24 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 50458-395_d2ad74ae-feb2-4ece-8a29-dc234867afe2 50458-395 HUMAN PRESCRIPTION DRUG RISPERDAL M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceuticals, Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 50458-396_d55c25ea-dc75-42f0-bd2f-5370374c1db0 50458-396 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide TABLET, FILM COATED ORAL 20010301 NDA NDA021169 Janssen Pharmaceuticals, Inc. GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 50458-397_d55c25ea-dc75-42f0-bd2f-5370374c1db0 50458-397 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide TABLET, FILM COATED ORAL 20010301 NDA NDA021169 Janssen Pharmaceuticals, Inc. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 50458-398_d55c25ea-dc75-42f0-bd2f-5370374c1db0 50458-398 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide TABLET, FILM COATED ORAL 20010301 NDA NDA021169 Janssen Pharmaceuticals, Inc. GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 50458-401_33f0802a-ceec-11e2-aed5-ce736188709b 50458-401 HUMAN PRESCRIPTION DRUG Doribax doripenem POWDER, FOR SOLUTION INTRAVENOUS 20071012 NDA NDA022106 Janssen Pharmaceuticals, Inc. DORIPENEM 500 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 50458-402_33f0802a-ceec-11e2-aed5-ce736188709b 50458-402 HUMAN PRESCRIPTION DRUG Doribax doripenem POWDER, FOR SOLUTION INTRAVENOUS 20101015 NDA NDA022106 Janssen Pharmaceuticals, Inc. DORIPENEM 250 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 50458-490_d55c25ea-dc75-42f0-bd2f-5370374c1db0 50458-490 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide SOLUTION ORAL 20010622 NDA NDA021224 Janssen Pharmaceuticals, Inc. GALANTAMINE HYDROBROMIDE 4 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 50458-513_0bb4fc65-8f7a-4708-b188-6976f8715080 50458-513 HUMAN PRESCRIPTION DRUG TYLENOL with Codeine acetaminophen and codeine phosphate TABLET ORAL 19770817 ANDA ANDA085055 Janssen Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 50458-515_0bb4fc65-8f7a-4708-b188-6976f8715080 50458-515 HUMAN PRESCRIPTION DRUG TYLENOL with Codeine acetaminophen and codeine phosphate TABLET ORAL 19770817 ANDA ANDA085055 Janssen Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 50458-531_7325732c-8475-4ed2-8189-4b9e2353be63 50458-531 HUMAN PRESCRIPTION DRUG Terazol 3 TERCONAZOLE SUPPOSITORY VAGINAL 19880524 NDA NDA019641 Janssen Pharmaceuticals, Inc. TERCONAZOLE 80 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 50458-535_7325732c-8475-4ed2-8189-4b9e2353be63 50458-535 HUMAN PRESCRIPTION DRUG Terazol 7 TERCONAZOLE CREAM VAGINAL 19871231 NDA NDA019579 Janssen Pharmaceuticals, Inc. TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 50458-536_7325732c-8475-4ed2-8189-4b9e2353be63 50458-536 HUMAN PRESCRIPTION DRUG Terazol 3 TERCONAZOLE CREAM VAGINAL 19910221 NDA NDA019964 Janssen Pharmaceuticals, Inc. TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 50458-540_6552742a-c766-4671-9990-3c7791478f5d 50458-540 HUMAN PRESCRIPTION DRUG INVOKAMET canagliflozin and metformin hydrochloride TABLET, FILM COATED ORAL 20140808 NDA NDA204353 Janssen Pharmaceuticals, Inc. CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 50; 500 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 50458-541_6552742a-c766-4671-9990-3c7791478f5d 50458-541 HUMAN PRESCRIPTION DRUG INVOKAMET canagliflozin and metformin hydrochloride TABLET, FILM COATED ORAL 20140808 NDA NDA204353 Janssen Pharmaceuticals, Inc. CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 50; 1000 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 50458-542_6552742a-c766-4671-9990-3c7791478f5d 50458-542 HUMAN PRESCRIPTION DRUG INVOKAMET canagliflozin and metformin hydrochloride TABLET, FILM COATED ORAL 20140808 NDA NDA204353 Janssen Pharmaceuticals, Inc. CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 150; 500 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 50458-543_6552742a-c766-4671-9990-3c7791478f5d 50458-543 HUMAN PRESCRIPTION DRUG INVOKAMET canagliflozin and metformin hydrochloride TABLET, FILM COATED ORAL 20140808 NDA NDA204353 Janssen Pharmaceuticals, Inc. CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 150; 1000 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] 50458-550_48dc2be6-b294-42c4-a0d4-63a291db4860 50458-550 HUMAN PRESCRIPTION DRUG INVEGA paliperidone TABLET, EXTENDED RELEASE ORAL 20061219 NDA NDA021999 Janssen Pharmaceuticals, Inc. PALIPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 50458-551_48dc2be6-b294-42c4-a0d4-63a291db4860 50458-551 HUMAN PRESCRIPTION DRUG INVEGA paliperidone TABLET, EXTENDED RELEASE ORAL 20061219 NDA NDA021999 Janssen Pharmaceuticals, Inc. PALIPERIDONE 6 mg/1 Atypical Antipsychotic [EPC] 50458-552_48dc2be6-b294-42c4-a0d4-63a291db4860 50458-552 HUMAN PRESCRIPTION DRUG INVEGA paliperidone TABLET, EXTENDED RELEASE ORAL 20061219 NDA NDA021999 Janssen Pharmaceuticals, Inc. PALIPERIDONE 9 mg/1 Atypical Antipsychotic [EPC] 50458-554_48dc2be6-b294-42c4-a0d4-63a291db4860 50458-554 HUMAN PRESCRIPTION DRUG INVEGA paliperidone TABLET, EXTENDED RELEASE ORAL 20090910 NDA NDA021999 Janssen Pharmaceuticals, Inc. PALIPERIDONE 1.5 mg/1 Atypical Antipsychotic [EPC] 50458-560_e6fbb086-1907-429c-8be0-b51df0d584e0 50458-560 HUMAN PRESCRIPTION DRUG INVEGA SUSTENNA paliperidone palmitate INJECTION INTRAMUSCULAR 20090731 NDA NDA022264 Janssen Pharmaceuticals, Inc. PALIPERIDONE PALMITATE 39 mg/.25mL Atypical Antipsychotic [EPC] 50458-561_e6fbb086-1907-429c-8be0-b51df0d584e0 50458-561 HUMAN PRESCRIPTION DRUG INVEGA SUSTENNA paliperidone palmitate INJECTION INTRAMUSCULAR 20090731 NDA NDA022264 Janssen Pharmaceuticals, Inc. PALIPERIDONE PALMITATE 78 mg/.5mL Atypical Antipsychotic [EPC] 50458-562_e6fbb086-1907-429c-8be0-b51df0d584e0 50458-562 HUMAN PRESCRIPTION DRUG INVEGA SUSTENNA paliperidone palmitate INJECTION INTRAMUSCULAR 20090731 NDA NDA022264 Janssen Pharmaceuticals, Inc. PALIPERIDONE PALMITATE 117 mg/.75mL Atypical Antipsychotic [EPC] 50458-563_e6fbb086-1907-429c-8be0-b51df0d584e0 50458-563 HUMAN PRESCRIPTION DRUG INVEGA SUSTENNA paliperidone palmitate INJECTION INTRAMUSCULAR 20090731 NDA NDA022264 Janssen Pharmaceuticals, Inc. PALIPERIDONE PALMITATE 156 mg/mL Atypical Antipsychotic [EPC] 50458-564_e6fbb086-1907-429c-8be0-b51df0d584e0 50458-564 HUMAN PRESCRIPTION DRUG INVEGA SUSTENNA paliperidone palmitate INJECTION INTRAMUSCULAR 20090731 NDA NDA022264 Janssen Pharmaceuticals, Inc. PALIPERIDONE PALMITATE 234 mg/1.5mL Atypical Antipsychotic [EPC] 50458-578_1f1adfad-818c-474f-b5ec-d477746a77a8 50458-578 HUMAN PRESCRIPTION DRUG Xarelto rivaroxaban TABLET, FILM COATED ORAL 20111104 NDA NDA202439 Janssen Pharmaceuticals, Inc. RIVAROXABAN 15 mg/1 Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] 50458-579_1f1adfad-818c-474f-b5ec-d477746a77a8 50458-579 HUMAN PRESCRIPTION DRUG Xarelto rivaroxaban TABLET, FILM COATED ORAL 20111105 NDA NDA202439 Janssen Pharmaceuticals, Inc. RIVAROXABAN 20 mg/1 Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] 50458-580_1f1adfad-818c-474f-b5ec-d477746a77a8 50458-580 HUMAN PRESCRIPTION DRUG Xarelto rivaroxaban TABLET, FILM COATED ORAL 20110701 NDA NDA022406 Janssen Pharmaceuticals, Inc. RIVAROXABAN 10 mg/1 Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] 50458-584_1f1adfad-818c-474f-b5ec-d477746a77a8 50458-584 HUMAN PRESCRIPTION DRUG XARELTO Rivaroxaban KIT 20140916 NDA NDA022406 Janssen Pharmaceuticals, Inc. 50458-585_379ad561-7b18-4cbd-84f4-f81bdfe89053 50458-585 HUMAN PRESCRIPTION DRUG CONCERTA Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20000801 NDA NDA021121 Janssen Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 50458-586_379ad561-7b18-4cbd-84f4-f81bdfe89053 50458-586 HUMAN PRESCRIPTION DRUG CONCERTA Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20000801 NDA NDA021121 Janssen Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 36 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 50458-587_379ad561-7b18-4cbd-84f4-f81bdfe89053 50458-587 HUMAN PRESCRIPTION DRUG CONCERTA Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20000801 NDA NDA021121 Janssen Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 54 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 50458-588_379ad561-7b18-4cbd-84f4-f81bdfe89053 50458-588 HUMAN PRESCRIPTION DRUG CONCERTA Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20000801 NDA NDA021121 Janssen Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 50458-590_ceb274dd-0b51-4864-aaf2-b8b56834769c 50458-590 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceutical, Inc. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 50458-591_ceb274dd-0b51-4864-aaf2-b8b56834769c 50458-591 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceutical, Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 50458-592_ceb274dd-0b51-4864-aaf2-b8b56834769c 50458-592 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceutical, Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 50458-593_ceb274dd-0b51-4864-aaf2-b8b56834769c 50458-593 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceutical, Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 50458-594_ceb274dd-0b51-4864-aaf2-b8b56834769c 50458-594 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceutical, Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 50458-595_ceb274dd-0b51-4864-aaf2-b8b56834769c 50458-595 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceutical, Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 50458-596_ceb274dd-0b51-4864-aaf2-b8b56834769c 50458-596 HUMAN PRESCRIPTION DRUG Risperidone risperidone SOLUTION ORAL 19960610 NDA NDA020588 Janssen Pharmaceutical, Inc. RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] 50458-601_ceb274dd-0b51-4864-aaf2-b8b56834769c 50458-601 HUMAN PRESCRIPTION DRUG Risperidone M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceutical, Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 50458-602_ceb274dd-0b51-4864-aaf2-b8b56834769c 50458-602 HUMAN PRESCRIPTION DRUG Risperidone M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceutical, Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 50458-603_ceb274dd-0b51-4864-aaf2-b8b56834769c 50458-603 HUMAN PRESCRIPTION DRUG Risperidone M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceutical, Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 50458-604_ceb274dd-0b51-4864-aaf2-b8b56834769c 50458-604 HUMAN PRESCRIPTION DRUG Risperidone M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceutical, Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 50458-605_ceb274dd-0b51-4864-aaf2-b8b56834769c 50458-605 HUMAN PRESCRIPTION DRUG Risperidone M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceutical, Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 50458-625_a0b7657a-90c6-4a59-8413-c0a7bc5c536c 50458-625 HUMAN PRESCRIPTION DRUG Parafon Forte DSC chlorzoxazone TABLET ORAL 19870615 NDA NDA011529 Janssen Pharmaceuticals, Inc. CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 50458-639_878f0ad0-5713-436a-873a-04a0d96e12d3 50458-639 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 Janssen Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50458-640_878f0ad0-5713-436a-873a-04a0d96e12d3 50458-640 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 Janssen Pharmaceuticals, Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50458-641_878f0ad0-5713-436a-873a-04a0d96e12d3 50458-641 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 Janssen Pharmaceuticals, Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50458-642_878f0ad0-5713-436a-873a-04a0d96e12d3 50458-642 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 Janssen Pharmaceuticals, Inc. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50458-645_878f0ad0-5713-436a-873a-04a0d96e12d3 50458-645 HUMAN PRESCRIPTION DRUG Topamax topiramate CAPSULE, COATED PELLETS ORAL 19981101 NDA NDA020844 Janssen Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50458-647_878f0ad0-5713-436a-873a-04a0d96e12d3 50458-647 HUMAN PRESCRIPTION DRUG Topamax topiramate CAPSULE, COATED PELLETS ORAL 19981101 NDA NDA020844 Janssen Pharmaceuticals, Inc. TOPIRAMATE 15 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50458-650_854c2053-daf5-44ff-a384-0b9c68b41cfe 50458-650 HUMAN PRESCRIPTION DRUG ULTRACET tramadol hydrochloride and acetaminophen TABLET, COATED ORAL 20010815 NDA NDA021123 Janssen Pharmaceuticals, Inc. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 50458-653_8450d32a-1409-4035-84b2-88ea5938ff05 50458-653 HUMAN PRESCRIPTION DRUG Ultram ER Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20051001 NDA NDA021692 Janssen Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 50458-655_8450d32a-1409-4035-84b2-88ea5938ff05 50458-655 HUMAN PRESCRIPTION DRUG Ultram ER Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20051001 NDA NDA021692 Janssen Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 50458-657_8450d32a-1409-4035-84b2-88ea5938ff05 50458-657 HUMAN PRESCRIPTION DRUG Ultram ER Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20051001 NDA NDA021692 Janssen Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 50458-659_2db26e2b-de11-49e6-8c43-6db121f993b8 50458-659 HUMAN PRESCRIPTION DRUG ULTRAM tramadol hydrochloride TABLET, COATED ORAL 19950303 NDA NDA020281 Janssen Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 50458-680_be262d81-632e-4aa1-bcc4-22b9af9755b8 50458-680 HUMAN PRESCRIPTION DRUG Nizoral ketoconazole SHAMPOO TOPICAL 19900831 NDA NDA019927 Janssen Pharmaceuticals, Inc. KETOCONAZOLE 20 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 50458-805_14509e2a-41c1-4605-b4f9-6663bd77ad0f 50458-805 HUMAN PRESCRIPTION DRUG Ditropan XL oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 19990626 NDA NDA020897 Janssen Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 50458-810_14509e2a-41c1-4605-b4f9-6663bd77ad0f 50458-810 HUMAN PRESCRIPTION DRUG Ditropan XL oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 19990626 NDA NDA020897 Janssen Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 50458-815_14509e2a-41c1-4605-b4f9-6663bd77ad0f 50458-815 HUMAN PRESCRIPTION DRUG Ditropan XL oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 19990626 NDA NDA020897 Janssen Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 50458-817_d3931d30-492b-4404-89ed-69c02160d8d0 50458-817 HUMAN PRESCRIPTION DRUG Nucynta tapentadol hydrochloride SOLUTION ORAL 20121015 NDA NDA203794 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 20 mg/mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50458-820_452e0da8-4f4a-478f-bf59-2d00094a3ca7 50458-820 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20090601 NDA NDA022304 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50458-830_452e0da8-4f4a-478f-bf59-2d00094a3ca7 50458-830 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20090601 NDA NDA022304 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 75 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50458-840_452e0da8-4f4a-478f-bf59-2d00094a3ca7 50458-840 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20090601 NDA NDA022304 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 100 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50458-860_e70749d1-72e4-4b92-8ecb-16b77508ff76 50458-860 HUMAN PRESCRIPTION DRUG NUCYNTA ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110825 NDA NDA200533 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50458-861_e70749d1-72e4-4b92-8ecb-16b77508ff76 50458-861 HUMAN PRESCRIPTION DRUG NUCYNTA ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110825 NDA NDA200533 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 100 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50458-862_e70749d1-72e4-4b92-8ecb-16b77508ff76 50458-862 HUMAN PRESCRIPTION DRUG NUCYNTA ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110825 NDA NDA200533 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 150 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50458-863_e70749d1-72e4-4b92-8ecb-16b77508ff76 50458-863 HUMAN PRESCRIPTION DRUG NUCYNTA ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110825 NDA NDA200533 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 200 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50458-864_e70749d1-72e4-4b92-8ecb-16b77508ff76 50458-864 HUMAN PRESCRIPTION DRUG NUCYNTA ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110825 NDA NDA200533 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 250 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50458-920_fda74acc-68e3-4d33-8738-bda052471a4d 50458-920 HUMAN PRESCRIPTION DRUG Levaquin levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 Janssen Pharmaceuticals, Inc. LEVOFLOXACIN 250 mg/1 50458-925_fda74acc-68e3-4d33-8738-bda052471a4d 50458-925 HUMAN PRESCRIPTION DRUG Levaquin levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 Janssen Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 50458-930_fda74acc-68e3-4d33-8738-bda052471a4d 50458-930 HUMAN PRESCRIPTION DRUG Levaquin levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 Janssen Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 50462-107_a3c86cb1-8bc6-4b16-8256-fe6e305acb75 50462-107 HUMAN OTC DRUG Noble Lion Medicated Balm Methyl Salicylate and Menthol LINIMENT TOPICAL 20120704 OTC MONOGRAPH FINAL part348 ABBP (ARRINGTON, BATTLE, BELL & PERRY), LLC MENTHOL; METHYL SALICYLATE 14.5; 30 mL/100mL; mL/100mL 50462-110_a3c86cb1-8bc6-4b16-8256-fe6e305acb75 50462-110 HUMAN OTC DRUG Noble Lion Medicated Balm Methyl Salicylate and Menthol LINIMENT TOPICAL 20120704 OTC MONOGRAPH FINAL part348 ABBP (ARRINGTON, BATTLE, BELL & PERRY), LLC MENTHOL; METHYL SALICYLATE 14.5; 30 mL/100mL; mL/100mL 50462-113_a3c86cb1-8bc6-4b16-8256-fe6e305acb75 50462-113 HUMAN OTC DRUG Noble Lion Medicated Balm Methyl Salicylate and Menthol LINIMENT TOPICAL 20120704 OTC MONOGRAPH FINAL part348 ABBP (ARRINGTON, BATTLE, BELL & PERRY), LLC MENTHOL; METHYL SALICYLATE 14.5; 30 mL/100mL; mL/100mL 50462-114_a3c86cb1-8bc6-4b16-8256-fe6e305acb75 50462-114 HUMAN OTC DRUG Noble Lion Medicated Balm Methyl Salicylate and Menthol LINIMENT TOPICAL 20120704 OTC MONOGRAPH FINAL part348 ABBP (ARRINGTON, BATTLE, BELL & PERRY), LLC MENTHOL; METHYL SALICYLATE 14.5; 30 mL/100mL; mL/100mL 50462-115_a3c86cb1-8bc6-4b16-8256-fe6e305acb75 50462-115 HUMAN OTC DRUG Noble Lion Medicated Balm Methyl Salicylate and Menthol LINIMENT TOPICAL 20120704 OTC MONOGRAPH FINAL part348 ABBP (ARRINGTON, BATTLE, BELL & PERRY), LLC MENTHOL; METHYL SALICYLATE 14.5; 30 mL/100mL; mL/100mL 50462-119_a3c86cb1-8bc6-4b16-8256-fe6e305acb75 50462-119 HUMAN OTC DRUG Noble Lion Medicated Balm Methyl Salicylate and Menthol LINIMENT TOPICAL 20120704 OTC MONOGRAPH FINAL part348 ABBP (ARRINGTON, BATTLE, BELL & PERRY), LLC MENTHOL; METHYL SALICYLATE 14.5; 30 mL/100mL; mL/100mL 50466-575_6f22381d-e90d-4a1d-bffc-705ca89ad96b 50466-575 HUMAN OTC DRUG Foaming Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part333 Interstate Solutions, Inc. BENZETHONIUM CHLORIDE 2 mg/mL 50474-001_c60dee02-4552-4455-9065-9e45c88e5f9c 50474-001 HUMAN PRESCRIPTION DRUG Keppra levetiracetam SOLUTION ORAL 20031020 NDA NDA021505 UCB, Inc. LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50474-002_7abc3c3f-2a8e-45e7-9519-0133c64f95c5 50474-002 HUMAN PRESCRIPTION DRUG Keppra levetiracetam INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060823 NDA NDA021872 UCB, Inc. LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50474-100_d198cefe-838d-4ca9-aaa2-f74b03ac3805 50474-100 HUMAN PRESCRIPTION DRUG Theo-24 theophylline anhydrous CAPSULE, EXTENDED RELEASE ORAL 19980421 ANDA ANDA087942 UCB, Inc. THEOPHYLLINE ANHYDROUS 100 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 50474-200_d198cefe-838d-4ca9-aaa2-f74b03ac3805 50474-200 HUMAN PRESCRIPTION DRUG Theo-24 theophylline anhydrous CAPSULE, EXTENDED RELEASE ORAL 19980120 ANDA ANDA087943 UCB, Inc. THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 50474-300_d198cefe-838d-4ca9-aaa2-f74b03ac3805 50474-300 HUMAN PRESCRIPTION DRUG Theo-24 theophylline anhydrous CAPSULE, EXTENDED RELEASE ORAL 19980220 ANDA ANDA087944 UCB, Inc. THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 50474-400_d198cefe-838d-4ca9-aaa2-f74b03ac3805 50474-400 HUMAN PRESCRIPTION DRUG Theo-24 theophylline anhydrous CAPSULE, EXTENDED RELEASE ORAL 19980109 ANDA ANDA081034 UCB, Inc. THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 50474-594_c60dee02-4552-4455-9065-9e45c88e5f9c 50474-594 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20000424 NDA NDA021035 UCB, Inc. LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50474-595_c60dee02-4552-4455-9065-9e45c88e5f9c 50474-595 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20000424 NDA NDA021035 UCB, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50474-596_c60dee02-4552-4455-9065-9e45c88e5f9c 50474-596 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20000424 NDA NDA021035 UCB, Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50474-597_c60dee02-4552-4455-9065-9e45c88e5f9c 50474-597 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20000424 NDA NDA021035 UCB, Inc. LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50474-598_7ad8bf13-c6eb-4486-9a1b-2291f71c92a6 50474-598 HUMAN PRESCRIPTION DRUG Keppra XR levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080924 NDA NDA022285 UCB, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50474-599_7ad8bf13-c6eb-4486-9a1b-2291f71c92a6 50474-599 HUMAN PRESCRIPTION DRUG Keppra XR levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090401 NDA NDA022285 UCB, Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 50474-700_40529a17-61dd-457c-bf63-2db322f3185c 50474-700 HUMAN PRESCRIPTION DRUG Cimzia certolizumab pegol KIT 20080420 BLA BLA125160 UCB, Inc. 50474-710_40529a17-61dd-457c-bf63-2db322f3185c 50474-710 HUMAN PRESCRIPTION DRUG Cimzia certolizumab pegol INJECTION, SOLUTION SUBCUTANEOUS 20090514 BLA BLA125160 UCB, Inc. CERTOLIZUMAB PEGOL 200 mg/mL 50474-801_cf5e27a6-ca06-40a3-a785-6c6360b3c6a6 50474-801 HUMAN PRESCRIPTION DRUG Neupro rotigotine PATCH, EXTENDED RELEASE TRANSDERMAL 20120402 NDA NDA021829 UCB, Inc. ROTIGOTINE 1 mg/24h 50474-802_cf5e27a6-ca06-40a3-a785-6c6360b3c6a6 50474-802 HUMAN PRESCRIPTION DRUG Neupro rotigotine PATCH, EXTENDED RELEASE TRANSDERMAL 20120402 NDA NDA021829 UCB, Inc. ROTIGOTINE 2 mg/24h 50474-803_cf5e27a6-ca06-40a3-a785-6c6360b3c6a6 50474-803 HUMAN PRESCRIPTION DRUG Neupro rotigotine PATCH, EXTENDED RELEASE TRANSDERMAL 20120402 NDA NDA021829 UCB, Inc. ROTIGOTINE 3 mg/24h 50474-804_cf5e27a6-ca06-40a3-a785-6c6360b3c6a6 50474-804 HUMAN PRESCRIPTION DRUG Neupro rotigotine PATCH, EXTENDED RELEASE TRANSDERMAL 20120402 NDA NDA021829 UCB, Inc. ROTIGOTINE 4 mg/24h 50474-805_cf5e27a6-ca06-40a3-a785-6c6360b3c6a6 50474-805 HUMAN PRESCRIPTION DRUG Neupro rotigotine PATCH, EXTENDED RELEASE TRANSDERMAL 20120402 NDA NDA021829 UCB, Inc. ROTIGOTINE 6 mg/24h 50474-806_cf5e27a6-ca06-40a3-a785-6c6360b3c6a6 50474-806 HUMAN PRESCRIPTION DRUG Neupro rotigotine PATCH, EXTENDED RELEASE TRANSDERMAL 20120402 NDA NDA021829 UCB, Inc. ROTIGOTINE 8 mg/24h 50474-808_cf5e27a6-ca06-40a3-a785-6c6360b3c6a6 50474-808 HUMAN PRESCRIPTION DRUG Neupro rotigotine KIT 20120402 NDA NDA021829 UCB, Inc. 50474-920_1584656b-a5fe-4aab-b040-c5ceddd08574 50474-920 HUMAN PRESCRIPTION DRUG Xyzal levocetirizine dihydrochloride TABLET, FILM COATED ORAL 20070809 NDA NDA022064 UCB, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 50474-921_1584656b-a5fe-4aab-b040-c5ceddd08574 50474-921 HUMAN PRESCRIPTION DRUG Xyzal levocetirizine dihydrochloride SOLUTION ORAL 20080402 NDA NDA022157 UCB, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 50474-930_bd0524f4-a7cc-4720-84e8-1d9917c7d528 50474-930 HUMAN PRESCRIPTION DRUG Lortab 5/325 hydrocodone bitartrate and acetaminophen TABLET ORAL 20140421 ANDA ANDA202214 UCB, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50474-931_bd0524f4-a7cc-4720-84e8-1d9917c7d528 50474-931 HUMAN PRESCRIPTION DRUG Lortab 7.5/325 hydrocodone bitartrate and acetaminophen TABLET ORAL 20140421 ANDA ANDA202214 UCB, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50474-932_bd0524f4-a7cc-4720-84e8-1d9917c7d528 50474-932 HUMAN PRESCRIPTION DRUG Lortab 10/325 hydrocodone bitartrate and acetaminophen TABLET ORAL 20140421 ANDA ANDA202214 UCB, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 50481-3201_84d728d6-b6f1-4df6-84e0-0bb157ca7567 50481-3201 HUMAN OTC DRUG Tussy Antiperspirant and Deodorant Original Fresh Spice ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100127 OTC MONOGRAPH FINAL part350 KCM Brands LLC ALUMINUM CHLOROHYDRATE 19 mL/100mL 50481-3300_9550e3c9-ed96-4db6-b700-5c56cc3b6aa9 50481-3300 HUMAN OTC DRUG Tussy Antiperspirant and Deodorant Invisible Original Fresh Spice ALUMINUM CHLOROHYDRATE STICK TOPICAL 20100127 OTC MONOGRAPH FINAL part350 KCM Brands LLC ALUMINUM CHLOROHYDRATE 20 g/100g 50484-212_9d8edc88-05a4-4efb-bcd0-ca5590f5e77d 50484-212 HUMAN OTC DRUG I.V. Prep Antiseptic Wipe ISOPROPYL ALCOHOL SOLUTION TOPICAL 19991001 OTC MONOGRAPH NOT FINAL part333 Smith & Nephew, Inc. ISOPROPYL ALCOHOL .57 1/1 50484-302_dd01e3f7-3618-39b2-b85d-35318fedabb7 50484-302 HUMAN OTC DRUG Secura Total Body Foam Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part333 Smith & Nephew, Inc. BENZETHONIUM CHLORIDE 1.3 uL/mL 50484-303_dd01e3f7-3618-39b2-b85d-35318fedabb7 50484-303 HUMAN OTC DRUG Secura Total Body Foam Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part333 Smith & Nephew, Inc. BENZETHONIUM CHLORIDE 1.3 uL/mL 50484-304_ef02c797-de2b-bcd8-2c38-899ee3f1d49f 50484-304 HUMAN OTC DRUG Secura Personal Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part333 Smith & Nephew, Inc. BENZETHONIUM CHLORIDE 1.3 uL/mL 50484-305_ef02c797-de2b-bcd8-2c38-899ee3f1d49f 50484-305 HUMAN OTC DRUG Secura Personal Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part333 Smith & Nephew, Inc. BENZETHONIUM CHLORIDE 1.3 mL/L 50484-308_b460bc42-089e-409a-a3ed-92c625fe56ca 50484-308 HUMAN OTC DRUG Secura Moisturizing Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part333 Smith & Nephew, Inc. BENZETHONIUM CHLORIDE 1.3 uL/mL 50484-309_b460bc42-089e-409a-a3ed-92c625fe56ca 50484-309 HUMAN OTC DRUG Secura Moisturizing Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part333 Smith & Nephew, Inc. BENZETHONIUM CHLORIDE 1.3 uL/mL 50484-311_eb9ff027-d012-e308-797e-ad01e2ab9cf0 50484-311 HUMAN OTC DRUG Secura Protective ZINC OXIDE CREAM TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part347 Smith & Nephew, Inc. ZINC OXIDE 100 mg/g 50484-312_eb9ff027-d012-e308-797e-ad01e2ab9cf0 50484-312 HUMAN OTC DRUG Secura Protective ZINC OXIDE CREAM TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part347 Smith & Nephew, Inc. ZINC OXIDE 100 mg/g 50484-315_d1c5cd1d-159f-8a3b-9ed1-4a268793d3bf 50484-315 HUMAN OTC DRUG Secura Protective PETROLATUM OINTMENT TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part347 Smith & Nephew, Inc. PETROLATUM 987.89 mg/g 50484-316_d1c5cd1d-159f-8a3b-9ed1-4a268793d3bf 50484-316 HUMAN OTC DRUG Secura Protective PETROLATUM OINTMENT TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part347 Smith & Nephew, Inc. PETROLATUM 987.89 mg/g 50484-322_37eadaaa-f2ad-4c8b-babf-3762c9ff777b 50484-322 HUMAN OTC DRUG Secura Dimethicone Protectant DIMETHICONE CREAM TOPICAL 20050801 OTC MONOGRAPH NOT FINAL part347 Smith & Nephew, Inc. DIMETHICONE 50 mg/g 50484-324_cdff1fd5-6d1c-5a91-2a9c-e1ac9ea277ed 50484-324 HUMAN OTC DRUG Secura Extra Protective ZINC OXIDE CREAM TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part347 Smith & Nephew, Inc. ZINC OXIDE 306.1 mg/g 50484-325_cdff1fd5-6d1c-5a91-2a9c-e1ac9ea277ed 50484-325 HUMAN OTC DRUG Secura Extra Protective ZINC OXIDE CREAM TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part347 Smith & Nephew, Inc. ZINC OXIDE 306.1 mg/g 50484-328_d1fb832a-4076-445c-50b4-96ea09de0336 50484-328 HUMAN OTC DRUG Secura Antifungal Greaseless MICONAZOLE NITRATE CREAM TOPICAL 20030801 OTC MONOGRAPH FINAL part333 Smith & Nephew, Inc. MICONAZOLE NITRATE 20 mg/g 50484-329_d1fb832a-4076-445c-50b4-96ea09de0336 50484-329 HUMAN OTC DRUG Secura Antifungal Extra Thick MICONAZOLE NITRATE CREAM TOPICAL 20030801 OTC MONOGRAPH FINAL part333 Smith & Nephew, Inc. MICONAZOLE NITRATE 20 mg/g 50484-341_d132a699-d8cb-6d2a-5626-ad34dd8589c3 50484-341 HUMAN OTC DRUG Secura EPC Skin Care Starter Kit ZINC OXIDE,BENZETHONIUM CHLORIDE KIT 20030801 OTC MONOGRAPH NOT FINAL part347 Smith & Nephew, Inc. 50484-342_edc1147f-07c8-ed1e-8dae-2f533cebee0b 50484-342 HUMAN OTC DRUG Secura Starter Kit BENZETHONIUM CHLORIDE,PETROLATUM KIT 20030801 OTC MONOGRAPH NOT FINAL part347 Smith & Nephew, Inc. 50484-343_ea233950-c1ef-610f-edf5-2df6d9e4733f 50484-343 HUMAN OTC DRUG Secura Personal Skin Care Kit BENZETHONIUM CHLORIDE,PETROLATUM KIT 20030801 OTC MONOGRAPH NOT FINAL part347 Smith & Nephew, Inc. 50484-344_af9fc248-068a-6874-3eab-ba57ea033028 50484-344 HUMAN OTC DRUG Secura Two Step Kit benzethonium chloride and zinc oxide cream KIT TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part347 Smith & Nephew, Inc. 50484-490_be4ec51e-5754-5181-2d93-e4c667d80ea5 50484-490 HUMAN OTC DRUG Dermal Wound Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 19910401 OTC MONOGRAPH NOT FINAL part333 Smith & Nephew, Inc. BENZETHONIUM CHLORIDE 1.3 uL/mL 50484-492_be4ec51e-5754-5181-2d93-e4c667d80ea5 50484-492 HUMAN OTC DRUG Dermal Wound Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 19940401 OTC MONOGRAPH NOT FINAL part333 Smith & Nephew, Inc. BENZETHONIUM CHLORIDE 1.3 uL/mL 50485-101_784ef895-d19f-4ab2-a26e-8eab661e4b02 50485-101 HUMAN OTC DRUG Healerz for Noses BENZALKONIUM CHLORIDE and LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333A Wellco Brands LLC BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g 50485-102_5fdb1314-c7bc-4543-9fb7-957161bff0ed 50485-102 HUMAN OTC DRUG Healerz for Itches HYDROCORTISONE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part348 Wellco Brands LLC HYDROCORTISONE 1 g/100g 50486-221_bec562bb-b81d-4913-a98c-b82844dde61c 50486-221 HUMAN OTC DRUG Encare Nonoxynol-9 INSERT VAGINAL 19990901 OTC MONOGRAPH NOT FINAL part333A Blairex Laboratories, Inc. NONOXYNOL-9 100 mg/1 50486-468_400e4d3e-aae2-43f9-9856-862eeea278e4 50486-468 HUMAN OTC DRUG Zilactin Early Relief Cold Sore benzyl alcohol GEL TOPICAL 20050630 OTC MONOGRAPH FINAL part346 Blairex Laboratories, Inc. BENZYL ALCOHOL .1 g/g 50486-550_a13c2fe1-3b43-49fa-a43c-118b95abcdcd 50486-550 HUMAN OTC DRUG Zilactin-B benzocaine GEL TOPICAL 20050629 OTC MONOGRAPH FINAL part346 Blairex Laboratories, Inc. BENZOCAINE .1 g/g 50486-616_b5fc9298-64fc-46ef-aaeb-afb05f7522bd 50486-616 HUMAN OTC DRUG Sleepinal diphenhydramine hydrochloride CAPSULE ORAL 19991001 OTC MONOGRAPH FINAL part338 Blairex Laboratories, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 50488-0901_0df9abaf-3997-4dde-8003-ae3d8d07cf39 50488-0901 HUMAN OTC DRUG Laxacin Docusate sodium and sennosides TABLET ORAL 20111001 OTC MONOGRAPH NOT FINAL part334 Alexso Inc DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 50488-1001_100ceb76-8ebe-437b-a8de-37cc76ece9bb 50488-1001 HUMAN OTC DRUG Terocin Lidocaine, Menthol PATCH TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 Alexso Inc. LIDOCAINE; MENTHOL 600; 600 mg/1; mg/1 50488-1129_5dbd5fc0-a27e-4979-aca7-28f73096fd5f 50488-1129 HUMAN OTC DRUG New Terocin Methyl Salicylate, Capsaicin, and Menthol LOTION TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part348 Alexso Inc. CAPSAICIN; MENTHOL; METHYL SALICYLATE .025; 10; 25 g/100mL; g/100mL; g/100mL 50488-1201_5e73f8c2-bc02-40e0-863e-7bcd03dd1546 50488-1201 HUMAN OTC DRUG Limencin Lidocaine and Menthol PATCH TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part348 Alexso Inc LIDOCAINE; MENTHOL 40; 40 mg/1; mg/1 50488-1231_85066887-44d0-4a4a-adee-670073e4b22c 50488-1231 HUMAN OTC DRUG Terocin Methyl Salicylate, Capsaicin, Menthol and Lidocaine Hydrochloride LOTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part348 Alexso Inc. CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE .025; 2.5; 10; 25 g/100mL; g/100mL; g/100mL; g/100mL 50488-1301_4e0ef82c-e225-40d7-aca3-07e6f33b1176 50488-1301 HUMAN PRESCRIPTION DRUG Relyyks Patch Menthol, Lidocaine PATCH TOPICAL 20141001 UNAPPROVED DRUG OTHER Alexso, Inc LIDOCAINE; MENTHOL 4; 5 g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 50488-1401_4b23c4f8-3931-4258-8dbb-cc9482741418 50488-1401 HUMAN PRESCRIPTION DRUG Relyyt Patch Menthol, Capsaicin PATCH TOPICAL 20141124 UNAPPROVED DRUG OTHER Alexso, Inc CAPSAICIN; MENTHOL .025; 5 g/100g; g/100g 50488-2626_6277062d-9937-476e-8e48-685bcef533d0 50488-2626 HUMAN PRESCRIPTION DRUG Morcin Acontium Napellus CREAM TOPICAL 20140320 UNAPPROVED HOMEOPATHIC Alexso, Inc ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; BELLADONNA LEAF; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWER; COLCHICUM AUTUMNALE FLOWER; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA WHOLE; HYPERICUM PERFORATUM; MATRICARIA RECUTITA 6; 6; 6; 6; 6; 5; 6; 4; 6; 6; 6; 6 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL 50491-585_bebff6bf-67b4-4f6a-aab7-f087c79f50b3 50491-585 HUMAN OTC DRUG Instant Foam Hand Sanitizer ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333 Dixie Packing & Seal Company ALCOHOL .7 mL/mL 50491-855_410b1726-9e33-424f-944e-8594e48669f9 50491-855 HUMAN OTC DRUG Instant Foam Hand Sanitizer ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333E Dixie Packing & Seal Company ALCOHOL .62 mL/mL 50493-0001_63350c4c-ea72-4fdf-92fc-bfa4188dd0a1 50493-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100118 UNAPPROVED MEDICAL GAS Service Drug OXYGEN 99 L/100L 50499-100_ada35464-8cb9-4107-a4c0-822bf7dffeca 50499-100 HUMAN OTC DRUG Dr MINERAL Nasal Spray SODIUM CHLORIDE SPRAY NASAL 20100131 OTC MONOGRAPH FINAL part349 MineralBio SODIUM CHLORIDE .39 mL/60mL 50499-200_c490aedc-1254-43dd-a51f-4be89e80dd12 50499-200 HUMAN OTC DRUG Dr MINERAL Anti-Itch Spray SODIUM CHLORIDE SPRAY TOPICAL 20100220 OTC MONOGRAPH FINAL part349 MineralBio MENTHOL; SODIUM CHLORIDE .05; .7 mL/100mL; mL/100mL 50499-300_6ed10c93-b0f4-4965-9417-c81bf2be4650 50499-300 HUMAN OTC DRUG Dr MINERAL Anti-Itch SODIUM CHLORIDE SPRAY TOPICAL 20100220 OTC MONOGRAPH FINAL part349 MineralBio MENTHOL; SODIUM CHLORIDE .05; .7 mL/100mL; mL/100mL 50505-001_7ab70959-9de4-457f-8851-2029873a0367 50505-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19640101 UNAPPROVED MEDICAL GAS James Supply and Rental Company OXYGEN 99 L/100L 50509-100_9b93761d-4ab6-47a0-b8bb-8894639dd9c1 50509-100 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate SOLUTION PARENTERAL 20100722 UNAPPROVED DRUG OTHER Onpharma, Inc. SODIUM BICARBONATE 84 mg/mL 50519-221_60c9f9c4-032c-45a3-85db-2239d362ccc5 50519-221 HUMAN OTC DRUG Sani-Gel ALCOHOL GEL TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 American Industrial Supply, Inc. ALCOHOL .7 mL/mL 50519-738_440f158e-0626-428e-9ad5-a49265926364 50519-738 HUMAN OTC DRUG Sani Spritz ALCOHOL LIQUID TOPICAL 20091231 OTC MONOGRAPH NOT FINAL part333 American Industrial Supply, Inc. ALCOHOL .7 mL/mL 50519-773_73ed2d6c-2168-47c6-81f4-6b5dc0b75335 50519-773 HUMAN OTC DRUG Sani Soft ALCOHOL AEROSOL, FOAM TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part333 American Industrial Supply, Inc. ALCOHOL 620 mg/g 50522-221_c7bf6427-61e9-4fec-b121-e23071010409 50522-221 HUMAN OTC DRUG Sani ALCOHOL GEL TOPICAL 20120524 OTC MONOGRAPH NOT FINAL part333E AIS Specialty Products, Inc. ALCOHOL .7 mL/mL 50523-000_040b5419-31be-40b7-a868-da8b360f8134 50523-000 HUMAN OTC DRUG DT Ice Cold Analgesic Menthol GEL TOPICAL 20101222 OTC MONOGRAPH FINAL part341 Volume Distributors, Inc. MENTHOL 1 g/100g 50523-100_5bc72876-5a5a-4e1a-9854-e31cebeac925 50523-100 HUMAN OTC DRUG SPA MYSTIQUE SKIN RELIEF OATMEAL DAILY MOISTURIZING DIMETHICONE LOTION TOPICAL 20120620 OTC MONOGRAPH FINAL part347 Volume Distributors, Inc. DIMETHICONE 13 mg/mL 50523-101_696b5c9d-ad61-4b60-b01b-21a566a9a431 50523-101 HUMAN OTC DRUG SPA Mystique Skin Protection Soothing Relief Moisturizing DIMETHICONE CREAM TOPICAL 20130109 OTC MONOGRAPH FINAL part347 Volume Distributors, Inc. DIMETHICONE 13 mg/mL 50523-488_aca9ddb6-412d-440b-9c1c-4e2210a97294 50523-488 HUMAN OTC DRUG Silky Smooth Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE CREAM TOPICAL 20110107 OTC MONOGRAPH FINAL part350 VOLUME DISTRIBUTORS ALUMINUM CHLOROHYDRATE 20 g/100g 50523-489_a4a13d86-7b23-41f4-922d-6d15ce4be2a5 50523-489 HUMAN OTC DRUG Xtreme Stick Anti-Perspirant and Deodorant ALUMINUM CHLOROHYDRATE CREAM TOPICAL 20110107 OTC MONOGRAPH FINAL part350 VOLUME DISTRIBUTORS ALUMINUM CHLOROHYDRATE 20 g/100g 50523-546_e73ec274-3f77-4eee-b07d-0b7ceaa01adc 50523-546 HUMAN OTC DRUG Bebelle for Kids Antibacterial Hand TRICLOSAN LIQUID TOPICAL 20101222 OTC MONOGRAPH NOT FINAL part333E Volume Distributors, Inc. TRICLOSAN .2 mL/100mL 50523-567_bd4a392f-5a0c-4300-af83-8b4049d57dfc 50523-567 HUMAN OTC DRUG DT ANTIBACTERIAL HAND TRICLOSAN SOAP TOPICAL 20100715 OTC MONOGRAPH NOT FINAL part333E VOLUME DISTRIBUTORS TRICLOSAN 1.5 mg/mL 50523-632_1a0d1ba2-c216-415a-9486-813549803baa 50523-632 HUMAN OTC DRUG DT Antibacterial Foaming Hand Wash TRICLOSAN LIQUID TOPICAL 20101222 OTC MONOGRAPH NOT FINAL part333E Volume Distributors, Inc. TRICLOSAN .15 mL/100mL 50523-739_7f1c6ad7-9db0-4274-aa74-4e9efbdfa128 50523-739 HUMAN OTC DRUG DT Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110722 OTC MONOGRAPH FINAL part355 Volume Distributors, Inc. SODIUM MONOFLUOROPHOSPHATE .1 g/100g 50523-740_f6be5d77-dcbc-458b-a4d0-f971d5fbe7d6 50523-740 HUMAN OTC DRUG DT Whitening Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110722 OTC MONOGRAPH FINAL part355 Volume Distributors, Inc. SODIUM MONOFLUOROPHOSPHATE .1 g/100g 50532-066_bc736980-23b1-11e2-b904-0002a5d5c51b 50532-066 HUMAN PRESCRIPTION DRUG Mesalamine Mesalamine SUSPENSION RECTAL 20100401 NDA AUTHORIZED GENERIC NDA019618 Franklin Pharmaceutical LLC MESALAMINE 4 g/60mL Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 50532-112_f2608534-332a-46af-98f1-87fa47226492 50532-112 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate HYOSCYAMINE SULFATE TABLET ORAL 20100501 UNAPPROVED DRUG OTHER Franklin Pharmaceutical LLC HYOSCYAMINE SULFATE .125 mg/1 50532-113_02ab3cb8-eac0-4bf9-9c25-5ed1173bab93 50532-113 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate SL HYOSCYAMINE SULFATE TABLET, SOLUBLE ORAL 20100501 UNAPPROVED DRUG OTHER Franklin Pharmaceutical LLC HYOSCYAMINE SULFATE .125 mg/1 50532-115_5ae1ed10-3ec3-4a6d-bf30-7b8085d37757 50532-115 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate HYOSCYAMINE SULFATE TABLET ORAL 20100501 UNAPPROVED DRUG OTHER Franklin Pharmaceutical LLC HYOSCYAMINE SULFATE .375 mg/1 50536-039_9b886300-68c0-4832-86ed-517d2e731029 50536-039 HUMAN OTC DRUG SANIFOAM HAND SANITIZER ALCOHOL LOTION TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A AMERICAN CHEMICAL AND SANITARY SUPPLY INC ALCOHOL 62 mL/100mL 50536-077_185d3235-1886-41d9-8e0f-1dcb0fa2652e 50536-077 HUMAN OTC DRUG PREVENT HAND SANITIZER ALCOHOL GEL TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A AMERICAN CHEMICAL AND SANITARY SUPPLY INC ALCOHOL 62 mL/100mL 50536-078_b33c9a99-0e81-4793-8d07-2f8593e9d8bc 50536-078 HUMAN OTC DRUG SANIFOAM HAND SANITIZER ALCOHOL GEL TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A AMERICAN CHEMICAL AND SANITARY SUPPLY INC ALCOHOL 62 mL/100mL 50536-101_0cfae509-e730-4604-9eae-52a6871349b7 50536-101 HUMAN OTC DRUG SUPER SUDS ANTI-BACTERIAL ALCOHOL SOAP TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A AMERICAN CHEMICAL AND SANITARY SUPPLY INC ALCOHOL 62 mL/100mL 50536-102_c63b6d76-fb9e-4c71-83af-0cd2311006fc 50536-102 HUMAN OTC DRUG T-CHEM ANTIMICROBIAL HAND ALCOHOL SOAP TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A AMERICAN CHEMICAL AND SANITARY SUPPLY INC ALCOHOL 62 mL/100mL 50536-192_b43f9b02-f843-4949-b93d-05adf9006e9e 50536-192 HUMAN OTC DRUG T-Chem E2 Rated CHLOROXYLENOL, TRICLOSAN SOAP TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A AMERICAN CHEMICAL AND SANITARY SUPPLY INC CHLOROXYLENOL; TRICLOSAN .45; .06 g/100mL; 1/100mL 50538-001_3f8653ea-0f28-41ae-bdb7-9bb718361f49 50538-001 HUMAN OTC DRUG All-Natural Pen Spray Silver Citrate AEROSOL, SPRAY TOPICAL 20100209 OTC MONOGRAPH NOT FINAL part333 HANGZHOU KARIC COMMODITIES CO., LTD. ANHYDROUS CITRIC ACID; SILVER CITRATE .15; .15 g/100g; g/100g 50539-221_32cc712f-dc81-4e98-945b-c57f47c9d77c 50539-221 HUMAN OTC DRUG Pure Hands ALCOHOL GEL TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Buck Head Products & Systems ALCOHOL .7 mL/mL 50544-001_038390ce-8684-4c27-98dc-9521d0e3964b 50544-001 HUMAN OTC DRUG Oil-Free Acne Cleanser Benzoyl Peroxide CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part333D University Medical Pharmaceuticals Corp BENZOYL PEROXIDE 2.5 g/100g 50544-004_f3aa84cc-d4dd-4fe2-96d2-90a6a4052e6d 50544-004 HUMAN OTC DRUG Therapeutic Sulfur Mask Sulfur CREAM TOPICAL 20110906 OTC MONOGRAPH FINAL part333D University Medical Pharmaceuticals Corp SULFUR 35 g/1000g 50544-100_56a897db-8b8f-4c86-92ec-dceaa84f3810 50544-100 HUMAN OTC DRUG AcneFree Severe Antibacterial Cleansing Wash Benzoyl Peroxide CREAM TOPICAL 20111221 OTC MONOGRAPH FINAL part333D University Medical Pharmaceuticals Corp BENZOYL PEROXIDE 2.5 mL/100mL 50544-101_56a897db-8b8f-4c86-92ec-dceaa84f3810 50544-101 HUMAN OTC DRUG AcneFree Severe Maximum Strength Repair Lotion Benzoyl Peroxide LOTION TOPICAL 20111220 OTC MONOGRAPH FINAL part333D University Medical Pharmaceuticals Corp BENZOYL PEROXIDE 10 mL/100mL 50544-301_dbf02fdc-bab0-4fab-a9ba-d92cfd134704 50544-301 HUMAN OTC DRUG AF Foam Clear Skin Acne Pore Cleanser Benzoyl Peroxide AEROSOL, FOAM TOPICAL 20111101 OTC MONOGRAPH FINAL part333D University Medical Pharmaceuticals Corp BENZOYL PEROXIDE 2.5 g/100g 50544-304_a5c8f9f0-a6cd-4163-99ad-db2ba00fbd92 50544-304 HUMAN OTC DRUG AF Foam Sensitive Acne Pore Cleanser Salicylic Acid AEROSOL, FOAM TOPICAL 20111115 OTC MONOGRAPH FINAL part333D University Medical Pharmaceuticals Corp SALICYLIC ACID 1.5 g/100g 50552-001_5d865601-206a-449d-88fe-feebb7d8a1fa 50552-001 HUMAN OTC DRUG Anti-Bacterial Wipes BENZALKONIUM CHLORIDE CLOTH TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part333 Tongling Jieya Biological Technology Co., Ltd. BENZALKONIUM CHLORIDE .155 1/1001 50554-002_5ed53a9a-8848-452b-ad1a-dddb344d7549 50554-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20140101 NDA NDA205850 DuPuy Oxygen & Supply Company, Inc. NITROGEN 990 mL/L 50554-005_584e1203-fbd6-44c6-86f1-8507ad194382 50554-005 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19540101 NDA NDA206009 DuPuy Oxygen & Supply Company, Inc. NITROUS OXIDE 990 mL/L 50554-006_f9ba5600-9b75-43aa-b1ea-f601cd825b72 50554-006 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20140113 NDA NDA205826 DuPuy Oxygen & Supply Company, Inc. AIR 1000 mL/L 50554-100_d2290beb-11fc-49bb-bc10-27de8c704fb5 50554-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140101 NDA NDA205849 DuPuy Oxygen & Supply Company, Inc. OXYGEN 990 mL/L 50556-001_9ebea00c-ffd4-47cb-afb8-189b0e1ba705 50556-001 HUMAN OTC DRUG SUPER BB ANTI WRINKLE AND SUN PROTECTION SPF36 TITANIUM DIOXIDE CREAM CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 UNHWA CORPORATION TITANIUM DIOXIDE 1.6 mL/30mL 50556-003_c3ab1ffd-4767-477b-9cbd-4773813d7683 50556-003 HUMAN OTC DRUG SUPER SERUM ANTI AGING AND FIRMING DIMETHICONE CREAM CUTANEOUS 20090401 OTC MONOGRAPH FINAL part347 UNHWA CORPORATION DIMETHICONE .7 mL/35mL 50556-004_67322f6b-875a-4019-828f-6b87391c46d7 50556-004 HUMAN OTC DRUG SUPER CREAM AGE CONTROL AND FIRMING DIMETHICONE CREAM CUTANEOUS 20091001 OTC MONOGRAPH FINAL part347 UNHWA CORPORATION DIMETHICONE .58 mL/45mL 50558-001_48eed65c-3411-47f9-9c3a-8dcc84c2ce23 50558-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19960401 UNAPPROVED MEDICAL GAS BGR Enterprises, Inc. dba Penn Oxygen & Supply Company OXYGEN 995 mL/L 50558-002_48eed65c-3411-47f9-9c3a-8dcc84c2ce23 50558-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen LIQUID RESPIRATORY (INHALATION) 19960401 UNAPPROVED MEDICAL GAS BGR Enterprises, Inc. dba Penn Oxygen & Supply Company OXYGEN 995 mL/L 50562-001_4e6644f4-a969-43ea-80c1-ff92a2c67399 50562-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090601 UNAPPROVED MEDICAL GAS Alliance Welding Supplies Inc dba Atlas Welding Supply OXYGEN 992 mL/L 50562-002_eda0896a-9db8-4e5e-8294-6d9212dfa5ff 50562-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20100601 UNAPPROVED MEDICAL GAS Alliance Welding Supplies Inc dba Atlas Welding Supply NITROGEN 992 mL/L 50563-101_33adff8a-5eec-4d4c-91c1-b1f8cca9fa8d 50563-101 HUMAN OTC DRUG Enchanted Moments Berries and Cream Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110607 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 g/100g 50563-102_dd4541b9-6b31-41d0-a1f4-760b23b69773 50563-102 HUMAN OTC DRUG Enchanted Moments Candy Apple Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110629 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 g/100g 50563-103_04f873b8-31b2-4ca5-94fc-d86f33a0b858 50563-103 HUMAN OTC DRUG Enchanted Moments Mistletoe Kisses Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 g/100g 50563-104_8401bbfe-a58f-49e6-8bbd-74e756818af0 50563-104 HUMAN OTC DRUG Enchanted Moments Vanilla Snow Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 g/100g 50563-105_be0e79a2-a13e-40a5-bcaf-efbf55184c12 50563-105 HUMAN OTC DRUG Body Luxuries Fresh Cotton Hand Sanitizer ALCOHOL LIQUID TOPICAL 20111007 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 g/100g 50563-106_b705dbc3-7ee4-4760-949d-e02c36dcbf0c 50563-106 HUMAN OTC DRUG Body Luxuries Sweet Lavender Hand Sanitizer ALCOHOL LIQUID TOPICAL 20111007 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 g/100g 50563-107_10f33869-ab1c-4408-9302-9223998b5ab9 50563-107 HUMAN OTC DRUG Bella Maison Tropical Vanilla Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120218 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 g/100g 50563-108_240fb7e3-d96f-49ae-baab-c1da05154e6f 50563-108 HUMAN OTC DRUG Bella Maison Coconut Pineapple Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120218 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 g/100g 50563-109_2701c8d9-18f8-4014-9144-40233a4b8c53 50563-109 HUMAN OTC DRUG Ocean Mist Scented Hand Sanitizer Anti-Bacterial BENZETHONIUM CHLORIDE LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. BENZETHONIUM CHLORIDE .13 g/100mL 50563-110_fcec2e97-45d1-4c3d-8f8d-a1993574bc5f 50563-110 HUMAN OTC DRUG Peach Sensation Scented Hand Sanitizer Anti-Bacterial BENZETHONIUM CHLORIDE LIQUID TOPICAL 20120628 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. BENZETHONIUM CHLORIDE .13 g/100mL 50563-111_5b50d462-2d19-47e1-9cb0-b04c127d2310 50563-111 HUMAN OTC DRUG Magnolia Blossom Scented Hand Sanitizer Anti-Bacterial BENZETHONIUM CHLORIDE LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. BENZETHONIUM CHLORIDE .13 g/100mL 50563-112_792b050f-8c64-4d68-9646-f7bbab86311e 50563-112 HUMAN OTC DRUG Pink Grapefruit Scented Hand Sanitizer Anti-Bacterial BENZETHONIUM CHLORIDE LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. BENZETHONIUM CHLORIDE .13 g/100mL 50563-113_838a9bbf-ef6e-44cc-ab60-37a2a27d7c85 50563-113 HUMAN OTC DRUG April Bath and Shower Cucumber Melon Scented Hand Sanitizer Anti-Bacterial CHLOROXYLENOL LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. CHLOROXYLENOL .5 g/100mL 50563-114_b0a1cbfc-b1b1-4425-946e-db4f7c321f11 50563-114 HUMAN OTC DRUG April Bath and Shower Sweet Blossom Scented Hand Sanitizer Anti-Bacterial CHLOROXYLENOL LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. CHLOROXYLENOL .5 g/100mL 50563-115_ce229c80-8b32-4497-962a-be10ccc21813 50563-115 HUMAN OTC DRUG April Bath and Shower Warm Vanilla Scented Hand Sanitizer Anti-Bacterial CHLOROXYLENOL LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. CHLOROXYLENOL .5 g/100mL 50563-116_9ea688d7-280f-4660-a8b5-9917a5ce03dc 50563-116 HUMAN OTC DRUG Body Luxuries French Lavender Waterless Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-117_aa569442-12a2-4e15-9f0c-fb5e924cd37d 50563-117 HUMAN OTC DRUG Body Luxuries Coconut Vanilla Waterless Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-118_359248fb-5522-451e-b114-a83b401dd7fb 50563-118 HUMAN OTC DRUG Body Luxuries Cherry Blossom Waterless Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120630 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-119_77903bd5-39a3-4d89-8580-a37fb2589302 50563-119 HUMAN OTC DRUG Body Luxuries Pineapple Mango Waterless Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120628 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-120_afa135c1-536b-4e6a-a5db-fef3ed676c48 50563-120 HUMAN OTC DRUG Raymond Waites Gerber Daisy Waterless Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120908 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-121_6f866143-d79e-4787-89a4-453a7024e41f 50563-121 HUMAN OTC DRUG Raymond Waites Gerber Daisy Waterless Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120908 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-122_69e8b844-afd8-4576-91e2-f3ddf5daea46 50563-122 HUMAN OTC DRUG Raymond Waites Honeysuckle Rose Waterless Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120908 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-123_96210b7e-2bdb-4721-ba50-144c3c07ea96 50563-123 HUMAN OTC DRUG Susan Winget Berries and Cream Hand Sanitizer ALCOHOL LIQUID TOPICAL 20121208 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-124_fc473a22-d3d7-41a6-bc75-ccdcf887373e 50563-124 HUMAN OTC DRUG Susan Winget Mango Orange Hand Sanitizer ALCOHOL LIQUID TOPICAL 20121218 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-125_40a5a072-2d6e-43a9-9221-e524106d7dd6 50563-125 HUMAN OTC DRUG Body Luxuries Moroccan Rose Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20121218 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-126_8a31dd1d-1ba6-47f9-80ad-cd0ae31de208 50563-126 HUMAN OTC DRUG Body Luxuries French Lavender Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20121218 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-127_157080f3-9a0c-402a-b49d-a0278ab70557 50563-127 HUMAN OTC DRUG Body Luxuries Tihitian Vanilla Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20121218 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-128_b7cd7b1c-77de-494f-95fa-e920de64ab19 50563-128 HUMAN OTC DRUG Body Luxuries English Pear Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20121218 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-129_cb394321-7ac5-43fb-b89c-858644249bb1 50563-129 HUMAN OTC DRUG Charlie girl Blueberry Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130509 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-130_6f2629ce-03c9-40bb-935d-1ecc9745dfd3 50563-130 HUMAN OTC DRUG Charlie girl Strawberry Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130509 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-131_b16e858c-b9d0-4670-b73b-6b6623455cf9 50563-131 HUMAN OTC DRUG Charlie girl Grape Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130509 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-132_97afeb31-646f-4f88-9ae9-0c8b6370d43d 50563-132 HUMAN OTC DRUG RUE21 Doughnut Sprinkles Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-133_9b122791-1029-4de7-bf53-0b9449596f2e 50563-133 HUMAN OTC DRUG RUE21 Midnight Musk Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-134_67b64c4e-0885-4950-9142-4304241021ac 50563-134 HUMAN OTC DRUG RUE21 Cotton Candy Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-135_b22e572f-0620-4ca8-86bc-eacbc92b10ab 50563-135 HUMAN OTC DRUG RUE21 Sugar Cookie Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-136_09b1fc0f-b422-4fcd-862b-32d7795765fe 50563-136 HUMAN OTC DRUG RUE21 Vanilla Spice Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-137_2d730cff-4674-40e2-8bed-36e19f7b0dd6 50563-137 HUMAN OTC DRUG RUE21 Cherry Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-138_daf30076-785d-47e3-91be-d64f6b8c815e 50563-138 HUMAN OTC DRUG RUE21 Apple Spice Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-139_63b40786-ea37-49fb-8d61-0d995b021d83 50563-139 HUMAN OTC DRUG RUE21 Ocean Breeze Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-140_2d276c45-839e-440a-ac0f-0e04bfaff19e 50563-140 HUMAN OTC DRUG RUE21 Strawberry Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-141_7a23e1a7-9722-487b-8249-e61ecc78269e 50563-141 HUMAN OTC DRUG RUE21 Peppermint Twist Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-142_18d86058-6e4c-4ac1-85d8-ede966129046 50563-142 HUMAN OTC DRUG RUE21 Cherry Blossom Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-143_6dae7eaa-24b3-4dfb-bc0a-c83abc8223fb 50563-143 HUMAN OTC DRUG RUE21 Runway 21 Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-144_c87734fc-5a80-4a4d-8cd5-90616095ce6c 50563-144 HUMAN OTC DRUG RUE21 Posh Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-145_8f41b5c8-ee91-41c8-b7dd-d950a7a13182 50563-145 HUMAN OTC DRUG Body Luxuries Lotus Flower Scented Waterless Anti Bacterial Hand gel ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-146_90f2996d-c334-4259-b7e7-334ed12bb857 50563-146 HUMAN OTC DRUG Body Luxuries Dahlia Blossom Scented Waterless Anti Bacterial Hand gel ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-147_a0f0a234-9610-491b-89bb-c1d5224aa389 50563-147 HUMAN OTC DRUG Body Luxuries Strawberry Scented Waterless Anti Bacterial Hand gel ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-148_e469255a-b993-485b-a618-26ed4b9f8d49 50563-148 HUMAN OTC DRUG Body Luxuries Blueberry Scented Waterless Anti Bacterial Hand gel ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-149_68b9ee12-304d-4faa-8638-588049875cf3 50563-149 HUMAN OTC DRUG Body Luxuries French Lavender Scented Waterless Anti Bacterial Hand gel ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-150_551712e8-2f48-4772-909f-c23f7590d4ad 50563-150 HUMAN OTC DRUG Raspberry Vanilla Scented Waterless Hand Sanitizer ALCOHOL GEL TOPICAL 20100222 OTC MONOGRAPH FINAL part333 Enchante Accessories, Inc ALCOHOL 62 mL/100mL 50563-151_a9c00d06-5f7f-4dfb-83d0-9a86bfb4938c 50563-151 HUMAN OTC DRUG Healing Waters Cucumber Melon Scented Waterless Hand Sanitizer ALCOHOL GEL TOPICAL 20100222 OTC MONOGRAPH FINAL part333 Enchante Accessories, Inc ALCOHOL 62 mL/100mL 50563-152_911214a6-48a9-4629-86f0-f4a59328d5a3 50563-152 HUMAN OTC DRUG Healing Waters Cherry Blossom Scented Waterless Hand Sanitizer ALCOHOL GEL TOPICAL 20100222 OTC MONOGRAPH FINAL part333 Enchante Accessories, Inc ALCOHOL 62 mL/100mL 50563-153_9a4d91be-8209-4b2a-96f8-fd33d6291f7c 50563-153 HUMAN OTC DRUG Body Luxuries Waterless Hand Sanitizer Ethyl Alcolhol LIQUID TOPICAL 20100621 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL 50563-154_402e84ca-af1a-4fe8-bee7-ece7db01c9d7 50563-154 HUMAN OTC DRUG Body Raves Antibacterial Hand Sanitizer - Wild Strawberry Ethyl Alcohol LIQUID TOPICAL 20100621 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL 50563-155_de57563b-3bda-4b2e-ae5e-1ac100147c1c 50563-155 HUMAN OTC DRUG Body Raves Antibacterial Hand Sanitizer - Lavender Vanilla Ethyl Alcohol LIQUID TOPICAL 20100621 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL 50563-160_de930654-8a5d-4e90-81d7-0ace313c0a1b 50563-160 HUMAN OTC DRUG Body Luxuries English Pear Scented Waterless Anti Bacterial Hand gel ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-161_576a9300-a353-40f6-aef4-c321ee96a9af 50563-161 HUMAN OTC DRUG Just 4 Girl Waterless Anti Bacterial Hand Sanitizer Berry Blast ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-162_848a678c-ab24-48ee-b54e-a86468269025 50563-162 HUMAN OTC DRUG RUE 21 Fallen Vixen Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-163_56b570f2-c3f6-49b9-8a25-627c9fd0bd6b 50563-163 HUMAN OTC DRUG RUE 21 Legend Blueberry Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-164_6f812a79-33f2-43dc-a8a8-4d502c89b353 50563-164 HUMAN OTC DRUG RUE 21 Free Spirit Fresh Flowers Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-165_ed43b469-06e3-4528-b1e5-59cd7077a775 50563-165 HUMAN OTC DRUG RUE 21 Young Strawberry Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-166_18d39064-fdc3-4a48-b9f9-5311e4a54ebd 50563-166 HUMAN OTC DRUG RUE 21 Queen Cherry Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-167_3b45d5e8-53ad-4a51-8ced-1e4021d819da 50563-167 HUMAN OTC DRUG RUE 21 Love Cherry Blossom Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-168_ab6a163d-3e81-40d6-81a8-db4c644bb4df 50563-168 HUMAN OTC DRUG RUE 21 Apple Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-169_e82c6b01-0e3e-4d50-8f6b-1914c32b58c2 50563-169 HUMAN OTC DRUG RUE 21 Sugar Cookie Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-170_f0302b56-f418-465a-acdb-e11181672f6e 50563-170 HUMAN OTC DRUG RUE 21 Dream Dance Love Vanilla Spice Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-171_14587702-10bf-4e99-bca4-07b6dc1e55e4 50563-171 HUMAN OTC DRUG RUE 21 Paris Creamsicle Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL 50563-176_465c7f67-1013-4539-bd2c-609b0a9944b6 50563-176 HUMAN OTC DRUG Jelly Bean Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-177_08a019c8-abf0-425d-a3f6-2b7e085c78b7 50563-177 HUMAN OTC DRUG Vanilla Sugar Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-178_5e3e924c-99c0-4589-a4a5-05dc8e2343f2 50563-178 HUMAN OTC DRUG Angel Foodcake Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-179_baf91ee4-aa99-4968-a5d2-72ecedfbcc07 50563-179 HUMAN OTC DRUG Pink Macaroon Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-180_f11cfab1-b052-4724-8d0e-faadd3678990 50563-180 HUMAN OTC DRUG Cotton Candy Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-181_11f34eb6-f4ef-47c0-89be-cdc40f8fe45b 50563-181 HUMAN OTC DRUG Passion Fruit Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-182_e27532f1-a40a-496e-93d7-eb45f13cb876 50563-182 HUMAN OTC DRUG Green Apple Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-183_e47f6114-6cf9-4a4e-ab86-cc33f0abde0e 50563-183 HUMAN OTC DRUG Blue Rasberry Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-184_5029ed1a-b53f-4f5d-9973-3d987bb794ca 50563-184 HUMAN OTC DRUG Creamsicle Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-185_da5165d4-aa86-4135-b1d5-7e07d3f60366 50563-185 HUMAN OTC DRUG Creamsicle Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-186_55d866bf-b255-4730-8162-9bc271ef3d44 50563-186 HUMAN OTC DRUG Pink Lemonade Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL 50563-200_4fccfc18-002d-4ef9-adae-26522d91adac 50563-200 HUMAN OTC DRUG Cranberry Vanilla Scented Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL 50563-201_59d88bcc-585c-434d-8ce9-1d21df71115a 50563-201 HUMAN OTC DRUG Sugar Cookies Scented Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL 50563-202_951d908e-7cec-4e0d-a639-997193a2006a 50563-202 HUMAN OTC DRUG Jingle Berry Scented Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL 50563-204_3e078a40-c0bb-4dce-9c6e-cc1ec9b5df6d 50563-204 HUMAN OTC DRUG Orange Spice Scented Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL 50563-300_dec06938-8de5-404b-b00a-9f2a0c8c7a97 50563-300 HUMAN OTC DRUG Vanilla Mint Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL 50563-301_558e39ad-4eb2-4494-8f96-4d169b15bf7b 50563-301 HUMAN OTC DRUG Sugared Pear Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL 50563-302_63861145-29a5-4afc-ae1a-d4b4dc88c3a9 50563-302 HUMAN OTC DRUG Vanilla Cupcake Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL 50563-303_0563acc8-bcbd-4b2c-a92e-e8b4fd53b929 50563-303 HUMAN OTC DRUG Peppermint Swirl Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL 50563-400_bfc49ce8-6eb7-47b8-bfaa-410b2e6fb4e4 50563-400 HUMAN OTC DRUG Aromafields Plumeria Scented Antibacterial Hand Wash TRICLOSAN LIQUID TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part333 Enchante Accessories TRICLOSAN .025 mL/100mL 50563-401_774dd919-b528-45ab-b3ef-48815b949a96 50563-401 HUMAN OTC DRUG Aromafields Tiger Lily Scented Antibacterial Hand Wash TRICLOSAN LIQUID TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part333 Enchante Accessories TRICLOSAN .025 mL/100mL 50563-402_cffdcb82-467e-4461-8d26-b626b0baf923 50563-402 HUMAN OTC DRUG Aromafields Jasmine Scented Antibacterial Hand Wash TRICLOSAN LIQUID TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part333 Enchante Accessories TRICLOSAN .025 mL/100mL 50563-403_84c0aeff-4798-47d1-8aac-4d40d5b96404 50563-403 HUMAN OTC DRUG Aromafields Lavender Scented Antibacterial Hand Wash TRICLOSAN LIQUID TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part333 Enchante Accessories TRICLOSAN .025 mL/100mL 50563-500_b14f78b9-58e0-450f-93ca-1c0e6a2f6dd1 50563-500 HUMAN OTC DRUG body luxuries Vanilla Frosting Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100120 OTC MONOGRAPH FINAL part333E Enchante Accessories, Inc. ALCOHOL 62 mL/100mL 50563-501_ce4ba711-aee3-4dcf-823f-0ca39b7f06e7 50563-501 HUMAN OTC DRUG body luxuries Strawberry Shortcake Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100120 OTC MONOGRAPH FINAL part333E Enchante Accessories, Inc. ALCOHOL 62 mL/100mL 50564-544_62529440-d079-4a5a-abd0-ef1134895b7b 50564-544 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Jerome Stevens Pharmaceuticals, Inc. DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 50564-545_62529440-d079-4a5a-abd0-ef1134895b7b 50564-545 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Jerome Stevens Pharmaceuticals, Inc. DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 50573-3550_dd921222-b1fa-495a-8883-e657dd77b050 50573-3550 HUMAN OTC DRUG Diaper Rash Skin Protectant Crema Cero ZINC OXIDE CREAM TOPICAL 20100224 OTC MONOGRAPH FINAL part347 Laboratorios Cero S.A. ZINC OXIDE 4.9 g/100g 50573-3560_11192570-eef5-43d5-9c24-68473fe2c049 50573-3560 HUMAN OTC DRUG Diaper Rash Skin Protectant Crema Cero With Aloe Vera ZINC OXIDE CREAM TOPICAL 20110526 OTC MONOGRAPH FINAL part347 Laboratorios Cero S.A. ZINC OXIDE 4.9 g/100g 50577-0001_ca7c81ad-3466-4678-b7d1-657c7397e7fe 50577-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100119 UNAPPROVED MEDICAL GAS Horn's Medical Supply, Inc. OXYGEN 99 L/100L 50580-100_6c17682f-c58f-41ae-ba74-b218c393a899 50580-100 HUMAN OTC DRUG Infants Motrin Ibuprofen SUSPENSION/ DROPS ORAL 20040601 NDA NDA020603 McNeil Consumer Healthcare Div McNeil-PPC, Inc IBUPROFEN 50 mg/1.25mL 50580-110_0afbc4f0-c3e0-42c3-b65f-30f94471b0c6 50580-110 HUMAN OTC DRUG Motrin IB Ibuprofen TABLET, FILM COATED ORAL 20000801 NDA NDA019012 McNeil Consumer Healthcare Div McNeil-PPC, Inc IBUPROFEN 200 mg/1 50580-112_19364304-ccf2-44af-90c6-bf59514d860f 50580-112 HUMAN OTC DRUG Tylenol Arthritis Pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 19981201 NDA NDA019872 McNeil Consumer Healthcare Div McNeil-PPC, Inc ACETAMINOPHEN 650 mg/1 50580-123_d88cf160-fdb4-4a2b-bc99-64a2b386b034 50580-123 HUMAN OTC DRUG Childrens TYLENOL acetaminophen SUSPENSION ORAL 20111101 OTC MONOGRAPH NOT FINAL part343 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN 160 mg/5mL 50580-134_3fe39ad2-5b8c-4444-91f6-71621c7a40a5 50580-134 HUMAN OTC DRUG Imodium A-D Loperamide Hydrochloride LIQUID ORAL 20050101 NDA NDA019487 McNeil Consumer Healthcare Div McNeil-PPC, Inc LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 50580-164_96d438b1-773c-438a-a06e-29df3c90ded3 50580-164 HUMAN OTC DRUG Childrens TYLENOL acetaminophen SUSPENSION ORAL 20140601 OTC MONOGRAPH NOT FINAL part343 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN 160 mg/5mL 50580-184_fafe867e-55b2-4813-8759-ad29ed704d33 50580-184 HUMAN OTC DRUG Childrens Motrin Ibuprofen SUSPENSION ORAL 20010901 NDA NDA020516 McNeil Consumer Healthcare Div. McNeil-PPC, Inc IBUPROFEN 100 mg/5mL 50580-191_2ba90e61-fe6b-487c-8fbc-847211595345 50580-191 HUMAN OTC DRUG Infants TYLENOL acetaminophen SUSPENSION ORAL 20130501 OTC MONOGRAPH NOT FINAL part343 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN 160 mg/5mL 50580-198_3c164203-dfb4-419b-9756-25bf96970029 50580-198 HUMAN OTC DRUG Motrin Infants Ibuprofen SUSPENSION/ DROPS ORAL 20010901 NDA NDA020603 McNeil Consumer Healthcare Div McNeil-PPC, Inc IBUPROFEN 50 mg/1.25mL 50580-223_154f057a-3732-4bb2-ae87-bac2ea07cb17 50580-223 HUMAN OTC DRUG Infants TYLENOL acetaminophen SUSPENSION ORAL 20130510 OTC MONOGRAPH NOT FINAL part343 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN 160 mg/5mL 50580-226_40dcdc36-1e25-41ed-b4c7-e9f5ed0ceb76 50580-226 HUMAN OTC DRUG Benadryl Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20080901 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div McNeil-PPC, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 50580-228_9fc36488-7107-4fd4-9184-2e19edf7a4e2 50580-228 HUMAN OTC DRUG Benadryl Allergy Liqui-Gels diphenhydramine hydrochloride CAPSULE, LIQUID FILLED ORAL 20090301 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div McNeil-PPC, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 50580-229_2b181200-daf2-402e-98d8-8a60e701a407 50580-229 HUMAN OTC DRUG TYLENOL SINUS Congestion and Pain Acetaminophen and Phenylephrine hydrochloride TABLET, COATED ORAL 20070701 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div McNeil-PPC, Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 50580-257_b5f9e34c-9c1f-476c-89c0-1cdde29842d7 50580-257 HUMAN OTC DRUG TYLENOL COLD MULTI-SYMPTOM DAYTIME Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride LIQUID ORAL 20060701 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 50580-269_f6469b61-0dbe-4257-8ba9-9ec58be48d59 50580-269 HUMAN OTC DRUG TYLENOL COLD MULTI-SYMPTOM Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride LIQUID ORAL 20060701 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div McNeil-PPC, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 50580-295_4f00468b-47b9-416a-a7f4-92c2b79db7ec 50580-295 HUMAN OTC DRUG IMODIUM A-D Loperamide hydrochloride TABLET ORAL 19891201 NDA NDA019860 McNeil Consumer Healthcare Div McNeil-PPC, Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 50580-296_e09ef5e9-17cf-4e9b-b316-01621e78b4a7 50580-296 HUMAN OTC DRUG Childrens TYLENOL Acetaminophen SUSPENSION ORAL 20040701 OTC MONOGRAPH NOT FINAL part343 McNeil Consumer Healthcare Div McNeil-PPC, Inc ACETAMINOPHEN 160 mg/5mL 50580-318_cbb12bb5-e230-4ef9-8d2f-685179aafb31 50580-318 HUMAN OTC DRUG Childrens Tylenol acetaminophen SUSPENSION ORAL 20100730 OTC MONOGRAPH NOT FINAL part343 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN 160 mg/5mL 50580-324_91a08095-e829-4c13-9441-a149c2cddcca 50580-324 HUMAN OTC DRUG TYLENOL Sinus Congestion And Pain Severe Acetaminophen, Guaifenesin, and Phenylephrine hydrochloride TABLET, FILM COATED ORAL 20120127 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 50580-338_854f808e-dfd3-4d28-ba52-9b0543478051 50580-338 HUMAN OTC DRUG IMODIUM Multi-Symptom Relief loperamide hydrochloride and dimethicone TABLET ORAL 20080701 NDA NDA021140 McNeil Consumer Healthcare Div. McNeil-PPC, Inc DIMETHICONE; LOPERAMIDE HYDROCHLORIDE 125; 2 mg/1; mg/1 50580-341_6dcb94cf-51be-4515-ac29-e4b5eb74260e 50580-341 HUMAN OTC DRUG Childrens Benadryl Allergy Plus Congestion Diphenhydramine hydrochloride and Phenylephrine hydrochloride SOLUTION ORAL 20140930 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div. McNeil-PPC, Inc DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 12.5; 5 mg/5mL; mg/5mL 50580-351_ec98fd04-fb47-4bd0-80d1-40929cb2545f 50580-351 HUMAN OTC DRUG TYLENOL Cold Multi-Symptom Severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine hydrochloride LIQUID ORAL 20080811 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div McNeil-PPC, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 50580-352_39a12033-e7bd-4a82-91cd-0bdaa2e29299 50580-352 HUMAN OTC DRUG TYLENOL COLD Multi-Symptom Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate, and Phenylephrine Hydrochloride LIQUID ORAL 20080701 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div McNeil-PPC, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 50580-378_9df4e7f0-92f5-4633-9f17-3f74f7a2cc8f 50580-378 HUMAN OTC DRUG Tylenol Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20141101 OTC MONOGRAPH NOT FINAL part343 McNeil Consumer Healthcare Div McNeil-PPC, Inc ACETAMINOPHEN 500 mg/1 50580-397_38ddbd87-6c8d-4589-b539-4bf68decc259 50580-397 HUMAN OTC DRUG Imodium A-D Loperamide hydrochloride TABLET, CHEWABLE ORAL 20070201 NDA NDA020448 McNeil Consumer Healthcare Div. McNeil-PPC, Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 50580-402_09745cc5-b7b3-4ae6-8c57-0daf286f1d84 50580-402 HUMAN OTC DRUG TYLENOL Cold And Flu Severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20110901 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div McNeil-PPC, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 50580-403_1fc064ab-907f-41c2-9d77-32fc4ff9c59e 50580-403 HUMAN OTC DRUG TYLENOL Cold and Flu Severe Acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride LIQUID ORAL 20100705 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div McNeil-PPC, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 50580-404_ab06d8fb-d75c-4545-994c-e3a411985144 50580-404 HUMAN OTC DRUG TYLENOL Cold Sore Throat Extra Strength Acetaminophen LIQUID ORAL 20100716 OTC MONOGRAPH NOT FINAL part343 McNeil Consumer Healthcare Div McNeil-PPC, Inc ACETAMINOPHEN 500 mg/15mL 50580-406_f65179ea-acbe-4bc0-8a10-186dc12401b6 50580-406 HUMAN OTC DRUG TYLENOL Cold Multi-Symptom Daytime acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride TABLET, FILM COATED ORAL 20120701 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 50580-449_a24469f7-591a-4897-aede-4989e30399ad 50580-449 HUMAN OTC DRUG TYLENOL Extra Strength Acetaminophen TABLET, COATED ORAL 19840819 OTC MONOGRAPH NOT FINAL part343 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN 500 mg/1 50580-451_4cb748c3-9ef4-4cb4-bd5c-80e075772458 50580-451 HUMAN OTC DRUG TYLENOL Extra Strength Acetaminophen TABLET, COATED ORAL 19940819 OTC MONOGRAPH NOT FINAL part343 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN 500 mg/1 50580-482_5c069526-5842-43b9-893e-d2e2feec7620 50580-482 HUMAN OTC DRUG Tylenol PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 19910424 OTC MONOGRAPH NOT FINAL part338 McNeil Consumer Healthcare Div McNeil-PPC, Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 50580-496_f67801b9-7045-4f84-abf0-3cdcc8c05843 50580-496 HUMAN OTC DRUG TYLENOL Regular Strength Acetaminophen TABLET ORAL 19990201 OTC MONOGRAPH NOT FINAL part343 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN 325 mg/1 50580-501_750fd441-8432-4b6d-b48d-5db566a90e3f 50580-501 HUMAN OTC DRUG TYLENOL Regular Strength Acetaminophen TABLET, FILM COATED ORAL 19990201 OTC MONOGRAPH NOT FINAL part343 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN 325 mg/1 50580-506_18d0a2c4-b8e2-4053-a5e7-ad5d4ff109c9 50580-506 HUMAN OTC DRUG Tylenol PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20140929 OTC MONOGRAPH NOT FINAL part343 McNeil Consumer Healthcare Div McNeil-PPC, Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 50580-534_9f53e40a-19de-4a43-bb52-d93ecd1d5f46 50580-534 HUMAN OTC DRUG Childrens Benadryl ALLERGY Diphenhydramine hydrochloride SOLUTION ORAL 20080701 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div. McNeil-PPC, Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 50580-536_ce4a10b9-f168-483c-81c1-117560e98b27 50580-536 HUMAN OTC DRUG Childrens Sudafed Nasal Decongestant Pseudoephedrine hydrochloride LIQUID ORAL 20081001 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div. McNeil-PPC, Inc PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg/5mL 50580-539_aff63442-255e-4eb0-a4ef-263815229aa7 50580-539 HUMAN OTC DRUG Sudafed 12 Hour Pressure And Pain Naproxen sodium and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101101 ANDA ANDA076518 McNeil Consumer Healthcare Div. McNeil-PPC, Inc NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 50580-545_f7fb0447-4bee-4ee7-a27e-41d88be7b0b6 50580-545 HUMAN OTC DRUG SUDAFED Pseudoephedrine Hydrochloride TABLET, COATED ORAL 20111001 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div. McNeil-PPC, Inc PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 50580-547_b3dc6b0a-e23f-4259-82d5-45bf6cb46806 50580-547 HUMAN OTC DRUG SUDAFED PE Pressure Plus Pain acetaminophen and phenylephrine hydrochloride TABLET, FILM COATED ORAL 20120701 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 50580-550_12eeba47-366e-447c-bc0c-5571145863bd 50580-550 HUMAN OTC DRUG Sudafed PE Pressure plus Pain plus Cough Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20130225 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 50580-563_92b155fd-5a77-4aac-a518-02b93053bc0b 50580-563 HUMAN OTC DRUG Motrin PM Ibuprofen and Diphenhydramine Citrate TABLET, COATED ORAL 20100111 ANDA ANDA079113 McNeil Consumer Healthcare Div McNeil-PPC, Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 50580-566_d407f745-2ee1-4424-904f-58783c8b6221 50580-566 HUMAN OTC DRUG TYLENOL Cold Head Congestion Severe Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20130715 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 50580-594_07090b21-bc6c-4d16-a49e-02f0622eb0f1 50580-594 HUMAN OTC DRUG TYLENOL SINUS CONGESTION AND PAIN DAYTIME Acetaminophen and Phenylephrine hydrochloride TABLET, FILM COATED ORAL 20120701 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 50580-601_a9cdb245-01a6-4455-85ff-0429fa671528 50580-601 HUMAN OTC DRUG Childrens MOTRIN Ibuprofen SUSPENSION ORAL 19950901 NDA NDA020516 McNeil Consumer Healthcare Div. McNeil-PPC, Inc IBUPROFEN 100 mg/5mL 50580-669_d97b7d59-8ac5-4759-95e9-cbd604c7f8e4 50580-669 HUMAN OTC DRUG Sudafed 24 Hour Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20081001 NDA NDA020021 McNeil Consumer Healthcare Div McNeil-PPC, Inc PSEUDOEPHEDRINE HYDROCHLORIDE 240 mg/1 50580-670_dd9e915f-5500-4ae1-81bb-e683e4b4a58c 50580-670 HUMAN OTC DRUG Sudafed 12 Hour Pseudoephedrine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080601 ANDA ANDA073585 McNeil Consumer Healthcare Div. McNeil-PPC, Inc PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 50580-679_40627549-4116-4722-b2c4-696dad7c1286 50580-679 HUMAN OTC DRUG Sudafed PE Pressure Plus Pain Plus Cold Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20130801 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 50580-680_9444097e-24ee-4b75-9dbe-5557c0b50bbb 50580-680 HUMAN OTC DRUG SUDAFED PE Pressure PLUS Pain PLUS Mucus Acetaminophen, Guaifenesin, and Phenylephrine hydrochloride TABLET, FILM COATED ORAL 20130701 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div. McNeil-PPC, Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 50580-726_4ece1664-e247-4f14-af19-a1d550ac87f2 50580-726 HUMAN OTC DRUG Zyrtec Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20081001 NDA NDA019835 McNeil Consumer Healthcare Division of McNeil-PPC, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 50580-728_de3b625e-5b0d-4b93-ab37-769c1fcec8b9 50580-728 HUMAN OTC DRUG ZYRTEC-D Allergy and Congestion Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20080101 NDA NDA021150 McNeil Consumer Healthcare Div McNeil-PPC, Inc CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 50580-730_a9487253-4bc4-4de5-adae-9df93154a026 50580-730 HUMAN OTC DRUG Childrens Zyrtec Cetirizine Hydrochloride SYRUP ORAL 20090601 NDA NDA022155 McNeil Consumer Healthcare Div McNeil-PPC, Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 50580-778_55af0c4e-093b-49ec-9d25-d27898e9e95f 50580-778 HUMAN OTC DRUG Zyrtec Cetirizine Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20140120 NDA NDA022578 McNeil Consumer Healthcare Div. McNeil-PPC, Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 50580-779_380cbc6a-aa02-4ab3-9488-0c72604789ed 50580-779 HUMAN OTC DRUG ZYRTEC Cetirizine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20100208 NDA NDA022429 McNeil Consumer Healthcare Div McNeil-PPC, Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 50580-781_d3e6cfd3-2f3c-4d9a-8b76-9a33471f4bbb 50580-781 HUMAN OTC DRUG Childrens Benadryl-D ALLERGY and SINUS Diphenhydramine hydrochloride and Phenylephrine hydrochloride SOLUTION ORAL 20080801 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div. McNeil-PPC, Inc DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 12.5; 5 mg/5mL; mg/5mL 50580-782_4716f328-ba6f-45dd-834a-e29e1c1511e5 50580-782 HUMAN OTC DRUG Childrens Zyrtec Allergy Cetirizine Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20140120 NDA NDA022578 McNeil Consumer Healthcare Div McNeil-PPC, Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 50580-784_42e74116-a50e-41c0-9e82-a5191a5ba0c0 50580-784 HUMAN OTC DRUG Childrens Sudafed PE NASAL DECONGESTANT Phenylephrine hydrochloride SOLUTION ORAL 20081001 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div. McNeil-PPC, Inc PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL 50580-785_a2ef3dcf-0bf3-414a-b1fc-315f11c6023e 50580-785 HUMAN OTC DRUG Childrens SUDAFED PE Cold and Cough Dextromethorphan hydrobromide and Phenylephrine hydrochloride SOLUTION ORAL 20081001 OTC MONOGRAPH FINAL part341 McNeil Consumer Healthcare Div. McNeil-PPC, Inc DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 50580-813_4c13906d-6e2a-4f91-b0f2-1bcce47e7e5b 50580-813 HUMAN OTC DRUG TYLENOL SORE THROAT Acetaminophen LIQUID ORAL 20050101 OTC MONOGRAPH NOT FINAL part343 McNeil Consumer Healthcare Div McNeil-PPC, Inc ACETAMINOPHEN 500 mg/15mL 50580-843_2321ee65-16df-47a0-898f-856c27e51bea 50580-843 HUMAN OTC DRUG Simply Sleep diphenhydramine hydrochloride TABLET, FILM COATED ORAL 20040201 OTC MONOGRAPH FINAL part338 McNeil Consumer Healthcare Div. McNeil-PPC, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 50580-895_c58b8f1c-0481-466a-b660-0c8df63dd74e 50580-895 HUMAN OTC DRUG Nizoral A-D Ketoconazole SHAMPOO TOPICAL 19990401 NDA NDA020310 McNeil Consumer Healthcare Div. McNeil-PPC, Inc KETOCONAZOLE 10 mg/mL 50593-001_77f40592-d27e-45af-ab84-d48dc95b44c9 50593-001 HUMAN OTC DRUG Pink Grape Fruit Waterless Anti-bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100210 OTC MONOGRAPH NOT FINAL part333 Taizhou Xinzhixuan Daily-Use Co., Ltd. ALCOHOL 62 g/100g 50593-002_0083c1f9-9189-4ca0-9f6a-249450b913f1 50593-002 HUMAN OTC DRUG Healing Waters Cucumber Mint Antibacterial Hand Soap TRICLOSAN LIQUID TOPICAL 20100210 OTC MONOGRAPH NOT FINAL part333 Taizhou Xinzhixuan Daily-Use Co., Ltd. TRICLOSAN .115 g/100g 50593-003_948df7ae-0e0d-49dd-a55b-282fadb84bc6 50593-003 HUMAN OTC DRUG Healing Waters Mandarin Vanilla Antibacterial Hand Soap TRICLOSAN LIQUID TOPICAL 20100210 OTC MONOGRAPH NOT FINAL part333 Taizhou Xinzhixuan Daily-Use Co., Ltd. TRICLOSAN .115 g/100g 50593-004_4b7b4a08-75d6-42ae-a287-bf098e162c95 50593-004 HUMAN OTC DRUG Healing Waters Sweet Pea Antibacterial Hand Soap TRICLOSAN LIQUID TOPICAL 20100210 OTC MONOGRAPH NOT FINAL part333 Taizhou Xinzhixuan Daily-Use Co., Ltd. TRICLOSAN .115 g/100g 50593-005_9eaf54fb-5951-44f0-a194-c735fbbf87aa 50593-005 HUMAN OTC DRUG Clinical Works Cucumber Melon Waterless Hand Sanitizer Alcohol LIQUID TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part333 Taizhou Xinzhixuan Daily-Use Co., Ltd. ALCOHOL 62 g/100g 50593-006_eac3dd3f-f0d9-4be9-9b40-fbd47fabb775 50593-006 HUMAN OTC DRUG Clinical Works Lavender Blossom Waterless Hand Sanitizer Alcohol LIQUID TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part333 Taizhou Xinzhixuan Daily-Use Co., Ltd. ALCOHOL 62 g/100g 50593-007_beecd4bf-d696-4d57-8f5b-ba72335650f0 50593-007 HUMAN OTC DRUG Clinical Works Pink Grapefruit Waterless Hand Sanitizer Alcohol LIQUID TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part333 Taizhou Xinzhixuan Daily-Use Co., Ltd. ALCOHOL 62 g/100g 50593-008_31c5471f-3a5d-41a3-b7f2-3dd5931cca45 50593-008 HUMAN OTC DRUG Clinical Works Ocean Breeze Waterless Hand Sanitizer Alcohol LIQUID TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part333 Taizhou Xinzhixuan Daily-Use Co., Ltd. ALCOHOL 62 g/100g 50597-010_a75ce2b8-f359-4bcc-a474-52605f809b64 50597-010 HUMAN PRESCRIPTION DRUG Oxygen oxygen GAS RESPIRATORY (INHALATION) 20100504 UNAPPROVED MEDICAL GAS W. H. Goodale Co. Inc. OXYGEN 210 mL/L 50600-001_416869ea-9d24-4d29-941a-95cf59eac966 50600-001 HUMAN OTC DRUG Correway Personal Lubricant Glycerin JELLY ENTERAL 20090501 OTC MONOGRAPH NOT FINAL part347 Ningbo Correway Cosmetics Co., Ltd. GLYCERIN 19.312 g/48.28g 50600-002_7b68e830-c387-492a-a31a-2f2001e1ca69 50600-002 HUMAN OTC DRUG Correway Sunscreen (Non-waterproof) Octinoxate CREAM TOPICAL 20100308 OTC MONOGRAPH NOT FINAL part352 Ningbo Correway Cosmetics Co., Ltd. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 35; 75; 50; 35 mg/g; mg/g; mg/g; mg/g 50600-003_fa432f97-c3e0-467d-a7d4-ada152c50677 50600-003 HUMAN OTC DRUG Correway Sunscreen (Waterproof) Zinc Oxide CREAM TOPICAL 20100423 OTC MONOGRAPH NOT FINAL part352 Ningbo Correway Cosmetics Co., Ltd. AVOBENZONE; ENZACAMENE; OCTINOXATE; ZINC OXIDE 10; 35; 70; 80 mg/g; mg/g; mg/g; mg/g 50600-004_edf63270-e217-4ad3-ad85-46b53fc77777 50600-004 HUMAN OTC DRUG Correway Sunscreen (Non-waterproof) Octinoxate CREAM TOPICAL 20100720 OTC MONOGRAPH NOT FINAL part352 Ningbo Correway Cosmetics Co., Ltd. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 35; 75; 50; 35 mg/g; mg/g; mg/g; mg/g 50607-1111_fb5e49f7-4aae-4bf4-bdc4-ba23bb2a7412 50607-1111 HUMAN OTC DRUG Instant Hand Sanitizer Instant Hand Sanitizer GEL TOPICAL 20100501 OTC MONOGRAPH FINAL part333 B8 Sales, Inc. ALCOHOL .6 g/.9g 50607-5600_51d351ee-2de5-45f1-a1c2-e1b05433a300 50607-5600 HUMAN OTC DRUG Triple Antibiotic Triple Antibiotic OINTMENT TOPICAL 20100501 OTC MONOGRAPH FINAL part333 B8 Sales, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 1/g; mg/g; 1/g 50607-5700_ecdf4659-d30b-42a6-a987-168a2e391542 50607-5700 HUMAN OTC DRUG First aid and Burn First aid and Burn CREAM TOPICAL 20100501 OTC MONOGRAPH FINAL part333 B8 Sales, Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g 50607-5802_9fa5a9a0-ed3b-4d00-8f8f-bd91076f587c 50607-5802 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20100501 OTC MONOGRAPH FINAL part347 B8 Sales, Inc. HYDROCORTISONE 10 mg/g 50629-1005_f3631ad1-cfe5-45b1-8062-3a76dc1a4aa7 50629-1005 HUMAN OTC DRUG RICHENNAPHARM GROWMAX Hair care Tonic LEVOMENTHOL LIQUID TOPICAL 20100428 UNAPPROVED DRUG OTHER SEWHA P&C INC ALPHA-TOCOPHEROL ACETATE; LEVOMENTHOL .2; .4 mL/200mL; mL/200mL 50629-1010_c76e93dd-0da7-41eb-9319-d44ad0c1bb92 50629-1010 HUMAN OTC DRUG MOLYHEN MENTHOL LIQUID TOPICAL 20110629 UNAPPROVED DRUG OTHER SEWHA P&C INC .ALPHA.-TOCOPHEROL ACETATE, D-; MENTHOL; PYRIDOXINE HYDROCHLORIDE; SWERTIA JAPONICA 2; 4; 2; 10 mL/200mL; mL/200mL; mL/200mL; mL/200mL 50633-210_2645decc-fcc7-48ab-a217-029dcd6d8ccc 50633-210 HUMAN PRESCRIPTION DRUG Voraxaze glucarpidase INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120401 BLA BLA125327 BTG International Inc. GLUCARPIDASE 1000 [USP'U]/1 50636-001_d2248934-7fc8-4f1f-9ca7-4fd5fcd91b0f 50636-001 HUMAN OTC DRUG antiperspirant deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100331 OTC MONOGRAPH FINAL part350 Frabel S.A de C.V. ALUMINUM CHLOROHYDRATE 15 mL/100mL 50636-002_0fe7be41-1ff2-43f4-9831-3fc1983b5d69 50636-002 HUMAN OTC DRUG antiperspirant deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100331 OTC MONOGRAPH FINAL part350 Frabel S.A de C.V. ALUMINUM CHLOROHYDRATE 15 mL/100mL 50636-003_7f404ca0-d463-416a-a7ce-dbf3404fc63d 50636-003 HUMAN OTC DRUG antiperspirant deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100331 OTC MONOGRAPH FINAL part350 Frabel S.A de C.V. ALUMINUM CHLOROHYDRATE 15 mL/100mL 50636-004_9d6e2def-c6ee-4dc7-9023-564c04e25958 50636-004 HUMAN OTC DRUG antiperspirant deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100331 OTC MONOGRAPH FINAL part350 Frabel S.A de C.V. ALUMINUM CHLOROHYDRATE 15 mL/100mL 50653-1001_3d47d557-c24e-49e7-840f-ca0cbf48a9b7 50653-1001 HUMAN OTC DRUG Bonogen hair care shampoo panthenol SHAMPOO TOPICAL 20100301 UNAPPROVED DRUG OTHER Bonogen Co., Ltd BIOTIN; NADIDE; PANTHENOL; PYRITHIONE ZINC .06; .3; .5; 2.1 g/100g; g/100g; g/100g; g/100g 50653-2001_7d820b69-58e8-4834-8131-cc58ad762124 50653-2001 HUMAN OTC DRUG Bonogen Plus hair care shampoo panthenol SHAMPOO TOPICAL 20100409 UNAPPROVED DRUG OTHER Bonogen Co., Ltd BIOTIN; NADIDE; PANTHENOL; PYRITHIONE ZINC .06; .3; .6; 2.1 g/100g; g/100g; g/100g; g/100g 50653-3001_ff548e74-db58-404e-be2b-1d85db798467 50653-3001 HUMAN OTC DRUG Bonogen Activator hair loss treatment BIOTIN LIQUID TOPICAL 20100425 UNAPPROVED DRUG OTHER Bonogen Co., Ltd BIOTIN .002 mL/mL 50653-4001_f86f54eb-fac3-4ba7-8d67-a49c7df6a0c7 50653-4001 HUMAN OTC DRUG Born Hair panthenol SHAMPOO TOPICAL 20100409 UNAPPROVED DRUG OTHER Bonogen Co., Ltd BIOTIN; NADIDE; PANTHENOL; PYRITHIONE ZINC .06; .3; .6; 2.1 g/100g; g/100g; g/100g; g/100g 50664-100_5163e38a-5b1c-4cf9-88a8-95030d88a329 50664-100 HUMAN OTC DRUG Herbasoul Male Genital Desensitizer Cream BENZOCAINE CREAM TOPICAL 20100223 OTC MONOGRAPH FINAL part348 Bodon Med Laboratories Ltd. BENZOCAINE 4.5 g/100g 50666-001_e5b471da-8358-4e09-a4b6-d647b716a078 50666-001 HUMAN OTC DRUG JIANZE ALCOHOL PREP PAD LARGE ISOPROPYL ALCOHOL SWAB TOPICAL 20120601 OTC MONOGRAPH FINAL part333A Changzhou Jianze Sanitary Material Co., Ltd. ISOPROPYL ALCOHOL 70 mL/100mL 50666-002_b44c4d10-4b2e-4064-bc13-8cfc5726f6b6 50666-002 HUMAN OTC DRUG JIANZE ALCOHOL PREP PAD MEDIUM ISOPROPYL ALCOHOL SWAB TOPICAL 20120601 OTC MONOGRAPH FINAL part333A Changzhou Jianze Sanitary Material Co., Ltd. ISOPROPYL ALCOHOL 70 mL/100mL 50666-003_3ae904dc-012e-4e47-9183-8186aaa53102 50666-003 HUMAN OTC DRUG JIANZE SURGICAL SCRUB BRUSH NAIL CLEANER POVIDONE-IODINE SPONGE TOPICAL 20120601 OTC MONOGRAPH FINAL part333E Changzhou Jianze Sanitary Material Co., Ltd. POVIDONE-IODINE 2 g/20g 50666-004_d6b92858-ceed-4880-90a0-c991d5d082f4 50666-004 HUMAN OTC DRUG JIANZE ALCOHOL ISOPROPYL ALCOHOL SWAB TOPICAL 20120606 OTC MONOGRAPH FINAL part333A Changzhou Jianze Sanitary Material Co., Ltd. ISOPROPYL ALCOHOL 70 mL/100mL 50666-005_8568d2c8-f9f4-4fcc-8745-b59927950f54 50666-005 HUMAN OTC DRUG JIANZE POVIDONE-IODINE POVIDONE-IODINE GEL TOPICAL 20120614 OTC MONOGRAPH FINAL part333E Changzhou Jianze Sanitary Material Co., Ltd. POVIDONE-IODINE 10 g/100g 50666-006_c6df728b-a711-4e1f-acc8-6e188c1368de 50666-006 HUMAN OTC DRUG JIANZE POVIDONE IODINE SCRUB POVIDONE-IODINE LIQUID TOPICAL 20120614 OTC MONOGRAPH FINAL part333E Changzhou Jianze Sanitary Material Co., Ltd. POVIDONE-IODINE 10 g/100g 50666-007_3a942c4f-72d0-4963-ac8b-831cbd46a948 50666-007 HUMAN OTC DRUG JIANZE FIRST AID ANTISEPTIC SKIN TOWELETTE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120614 OTC MONOGRAPH FINAL part333A Changzhou Jianze Sanitary Material Co., Ltd. BENZALKONIUM CHLORIDE .13 g/100g 50666-008_2043ea3a-4c3a-499d-bfc8-f1664f3ceeeb 50666-008 HUMAN OTC DRUG JIANZE STING RELIEF PADS BENZOCAINE LIQUID TOPICAL 20120614 OTC MONOGRAPH FINAL part348 Changzhou Jianze Sanitary Material Co., Ltd. BENZOCAINE 6 g/100g 50666-009_a2de7bd5-82e1-4c78-8941-24181fc913d9 50666-009 HUMAN OTC DRUG JIANZE WASH TOWELETTE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120614 OTC MONOGRAPH FINAL part333A Changzhou Jianze Sanitary Material Co., Ltd. BENZALKONIUM CHLORIDE .13 g/100g 50672-838_93d9496a-952d-456b-9738-fceb351103b6 50672-838 HUMAN OTC DRUG Antibacterial Wet Wipes Benzalkonium Chloride SWAB TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A MC Group Development Ltd. BENZALKONIUM CHLORIDE .1 g/100g 50682-507_409093a5-b4f0-4857-b3d6-3d40481511d4 50682-507 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20120116 UNAPPROVED DRUG OTHER 3T Federal Solutions LLC SALSALATE 500 mg/1 50682-508_409093a5-b4f0-4857-b3d6-3d40481511d4 50682-508 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20120116 UNAPPROVED DRUG OTHER 3T Federal Solutions LLC SALSALATE 750 mg/1 50682-527_dec971e0-6bec-4ae4-aec4-76c8ded82c47 50682-527 HUMAN OTC DRUG LidoPatch Pain Relief lidocaine and menthol PATCH TRANSDERMAL 20120201 OTC MONOGRAPH NOT FINAL part348 3T Federal Solutions LLC LIDOCAINE; MENTHOL 40; 50 mg/1; mg/1 50685-001_c00d1071-a360-415d-af59-4c23d64e53f1 50685-001 HUMAN OTC DRUG Good Care Povidone Iodine POVIDONE-IODINE SWAB TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333A Dalian Goodwood Medical Care Ltd. POVIDONE-IODINE 10 mL/100mL 50685-002_24bb3855-c800-441e-ac3e-5ab6a3b199b1 50685-002 HUMAN OTC DRUG Good Care Isopropyl Alcohol ISOPROPYL ALCOHOL SWAB TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333A Dalian Goodwood Medical Care Ltd. ISOPROPYL ALCOHOL 70 mL/100mL 50685-004_2614486b-10d2-4b2b-87d0-a8c5ff269471 50685-004 HUMAN OTC DRUG Good Care Surgical Brush With Nail Cleaner POVIDONE-IODINE SPONGE TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333A Dalian Goodwood Medical Care Ltd. POVIDONE-IODINE 10 mL/100mL 50685-005_f31bd0b5-a920-4807-a0b7-093101e3537e 50685-005 HUMAN OTC DRUG Good Care Surgical Brush With Nail Cleaner POVIDONE-IODINE SPONGE TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333A Dalian Goodwood Medical Care Ltd. POVIDONE-IODINE 7.5 mL/100mL 50685-006_c71b9e6b-b633-404e-83fe-ef3f950cc0ad 50685-006 HUMAN OTC DRUG Good Care Alcohol Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part333A Dalian Goodwood Medical Care Ltd. ISOPROPYL ALCOHOL 70 g/100g 50685-007_dc36edc7-08b8-435e-9071-3f9e0c739d33 50685-007 HUMAN OTC DRUG Good Care Povidone Iodine Pad POVIDONE-IODINE SWAB TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part333A Dalian Goodwood Medical Care Ltd. POVIDONE-IODINE 10 g/100g 50685-008_424d19aa-9e50-42a7-8a79-0892060bf151 50685-008 HUMAN OTC DRUG Good Care Sterile Scrub Brush with PCMX CHLOROXYLENOL SOLUTION TOPICAL 20130213 OTC MONOGRAPH FINAL part333E Dalian Goodwood Medical Care Ltd. CHLOROXYLENOL 3.3 g/100g 50685-009_acfdbb6e-316a-4fa0-9819-7612d49eb92b 50685-009 HUMAN OTC DRUG Good Care Povidone Iodine Swabsticks POVIDONE-IODINE SWAB TOPICAL 20130213 OTC MONOGRAPH FINAL part333E Dalian Goodwood Medical Care Ltd. POVIDONE-IODINE 10 g/100g 50693-276_da33d3c6-f991-4c07-b3ed-5929e9af5a55 50693-276 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19790101 UNAPPROVED MEDICAL GAS Dixie Welding Supply Co, Inc. OXYGEN 99.5 L/100L 50699-1072_a6a1f0c9-cf22-43b1-9cbc-9f27fec9c225 50699-1072 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19770101 UNAPPROVED MEDICAL GAS Atlas Welding Supply Co., Inc. OXYGEN 99 L/100L 50728-510_8926bd49-6c43-44ce-b8fd-3c9905ad5065 50728-510 HUMAN OTC DRUG Nans Healing Aconitum Napellus, Arnica Montana, Arsenicum Iodatum, Belladonna, Bellis Perenis, Bryonia, Calendula Officinalis, Chamomilla Matricaria, Echinacea Angustifolia, Echinacea Purpurea, Graphites, Hamameli OINTMENT TOPICAL 20100801 UNAPPROVED HOMEOPATHIC Eycnan, LLC ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIIODIDE; BELLADONNA LEAF; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; STELLARIA MEDIA; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 8; 3; 3; 3; 4; 3; 3; 3; 3; 8; 3; 3; 8; 3; 3; 9; 6; 3; 4; 3; 5; 3; 3 [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_C]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g 50730-1000_e8f9eebb-679f-4252-b54a-652fa7a0479b 50730-1000 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .13 mL/mL 50730-1001_12b9b3c5-5a05-4595-87bc-cc53bcbf1fd7 50730-1001 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .13 mL/mL 50730-1004_2e9ca551-7499-44bf-b013-228f7e3bdff1 50730-1004 HUMAN OTC DRUG Bisacodyl bisacodyl SUPPOSITORY RECTAL 20090101 OTC MONOGRAPH FINAL part334 H and P Industries, Inc. dba Triad Group BISACODYL 10 mg/1 50730-1016_7c90787f-4b8f-48a9-a416-35d7c5f1b5e8 50730-1016 HUMAN OTC DRUG Bisacodyl bisacodyl SUPPOSITORY RECTAL 20090101 OTC MONOGRAPH FINAL part334 H and P Industries, Inc. dba Triad Group BISACODYL 10 mg/1 50730-1020_c5c5716a-a492-4e6d-bbbf-05fdb9ffbff8 50730-1020 HUMAN OTC DRUG Isopropyl Alcohol Swabs isopropyl alcohol SWAB TOPICAL 20071001 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 50730-1033_3552f34e-b5c4-48ce-8060-47c766193011 50730-1033 HUMAN OTC DRUG Isopropyl alcohol Prep Pad isopropyl alcohol SWAB TOPICAL 20070928 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 50730-1059_0ecd0a0a-2d8d-42a8-af4a-8201a7cacd4c 50730-1059 HUMAN OTC DRUG Isopropyl alcohol Prep Pad isopropyl alcohol SWAB TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 50730-1089_edc68e78-f911-4a5a-8c76-8d448f3edee6 50730-1089 HUMAN OTC DRUG Isopropyl Alcohol Swabs isopropyl alcohol SWAB TOPICAL 20050101 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 50730-1091_5d77ae33-8fe6-41f1-b028-ba5a6d003b03 50730-1091 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20090701 OTC MONOGRAPH FINAL part334 H and P Industries, Inc. dba Triad Group GLYCERIN 2 g/1 50730-1092_6c6213c3-4563-4b0b-b676-f348ec934036 50730-1092 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20030420 OTC MONOGRAPH FINAL part334 H and P Industries, Inc. dba Triad Group GLYCERIN 1.614 g/1 50730-1238_56b021e0-497c-44dc-9ddf-87f6ffe81f7c 50730-1238 HUMAN OTC DRUG Isopropyl Alcohol Prep Swab isopropyl alcohol SWAB TOPICAL 20030601 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 50730-1404_975d3fa6-36b6-49dd-8f42-30eae5ebce00 50730-1404 HUMAN OTC DRUG Alcohol Swabs with Benzocaine alcohol and benzocaine SWAB TOPICAL 20100405 OTC MONOGRAPH NOT FINAL part348 Triad Group BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 50730-1410_cac2e470-8e7c-406a-8606-f320b1ca90fc 50730-1410 HUMAN OTC DRUG Alcohol Prep Pad with Benzocaine benzocaine SWAB TOPICAL 20080601 OTC MONOGRAPH NOT FINAL part348 H and P Industries, Inc. dba Triad Group BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 50730-1411_0de077c4-4843-4d07-aa29-86475adc3f8f 50730-1411 HUMAN OTC DRUG Alcohol Prep Pad with Benzocaine benzocaine SWAB TOPICAL 20080701 OTC MONOGRAPH NOT FINAL part348 H and P Industries, Inc. dba Triad Group BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 50730-1450_b025f2ae-2e20-4cff-bbca-65c9239226ec 50730-1450 HUMAN OTC DRUG Alcohol Prep Swab with Pain Relief benzocaine SWAB TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part348 H and P Industries, Inc. dba Triad Group BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 50730-1481_ec714dbf-89f7-476e-bad9-a8ef85aa6837 50730-1481 HUMAN OTC DRUG cocoa butter, phenylephrine hydrochloride, shark liver oil cocoa butter, phenylephrine hydrochloride, shark liver oil SUPPOSITORY RECTAL 20040306 OTC MONOGRAPH FINAL part346 H and P Industries, Inc. dba Triad Group COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2077; 6; 73 mg/1; mg/1; mg/1 50730-1512_1162e9c4-000e-488f-b042-043743aad63c 50730-1512 HUMAN OTC DRUG Hemorrhoidal Starch starch SUPPOSITORY RECTAL 20060801 OTC MONOGRAPH FINAL part346 H and P Industries, Inc. dba Triad Group STARCH, CORN .51 g/1 50730-2000_52ca50c3-5890-4f93-ab96-67b39ddb13dc 50730-2000 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .13 mL/mL 50730-2001_d4aa6122-d5aa-4144-b45e-cbeaa358e738 50730-2001 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .13 mL/mL 50730-2005_04b7b28b-3470-49c7-a4a7-b6aead4020a8 50730-2005 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .13 mL/mL 50730-3001_e185f1ee-efff-4b33-b693-ffce9a28ef5b 50730-3001 HUMAN OTC DRUG Isopropyl alcohol isopropyl alcohol SWAB TOPICAL 19860501 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 50730-3002_613db179-9d50-4c78-a55e-a74e5f7d3fe1 50730-3002 HUMAN OTC DRUG Isopropyl alcohol isopropyl alcohol SWAB TOPICAL 19860501 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 50730-3003_f45899d3-8868-4729-a0c3-354cae3d0bcd 50730-3003 HUMAN OTC DRUG Isopropyl alcohol isopropyl alcohol SWAB TOPICAL 19860501 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 50730-3004_99770d6c-f3d8-4605-8884-eb690b3c771d 50730-3004 HUMAN OTC DRUG Isopropyl alcohol isopropyl alcohol SWAB TOPICAL 19860501 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 50730-3101_90755816-c7dd-449b-9ac4-ee25289818ba 50730-3101 HUMAN OTC DRUG Isopropyl alcohol isopropyl alcohol SWAB TOPICAL 19960930 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 50730-3201_fb26f261-407b-4f86-881e-f0fd068f9ceb 50730-3201 HUMAN OTC DRUG Povidone Iodine Prep Pad povidone-iodine SOLUTION EPIDURAL; PERCUTANEOUS; TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .1 g/1 50730-4101_195f25e7-21ce-4c6d-bedb-b79ceb28b385 50730-4101 HUMAN OTC DRUG Povidone-Iodine Prep Swabstick povidone-iodine SOLUTION EPIDURAL; PERCUTANEOUS; TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .1 mg/mL 50730-4102_021d76b8-2021-43e7-be7c-cf9135742bcb 50730-4102 HUMAN OTC DRUG Povidone-Iodine Prep Swabsticks povidone-iodine SOLUTION EPIDURAL; PERCUTANEOUS; TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 Triad Group POVIDONE-IODINE .1 mg/mL 50730-4300_96758b29-178e-4fd4-97af-ce05768de078 50730-4300 HUMAN OTC DRUG Isopropyl alcohol Swabsticks isopropyl alcohol LIQUID TOPICAL 19860501 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/mL 50730-4301_323b2954-3b60-43ce-823c-692832ea9695 50730-4301 HUMAN OTC DRUG Isopropyl alcohol Swabstick Sterile isopropyl alcohol LIQUID TOPICAL 19860501 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/mL 50730-4401_605ef4ee-a9f1-4437-8882-c071bba9caad 50730-4401 HUMAN OTC DRUG Povidone-Iodine Scrub Swabstick povidone-iodine SOLUTION TOPICAL 19870114 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .075 mg/mL 50730-4402_0926eb7c-d18c-4f74-bc07-79e1c0852e89 50730-4402 HUMAN OTC DRUG Povidone-Iodine Scrub Swabsticks povidone-iodine SOLUTION TOPICAL 19870114 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .075 mg/mL 50730-4536_ed0362d7-00a3-4082-b613-93b865efccce 50730-4536 HUMAN OTC DRUG mineral oil, petrolatum, phenylephrine hydrochloride, shark liver oil mineral oil, petrolatum, phenylephrine hydrochloride, shark liver oil OINTMENT RECTAL; TOPICAL 20050701 OTC MONOGRAPH FINAL part346 H and P Industries, Inc. dba Triad Group LIGHT MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 140; 719; 2.5; 30 mg/g; mg/g; mg/g; mg/g 50730-4812_1065863d-fc11-4ca8-86f2-76ba8eba05c5 50730-4812 HUMAN OTC DRUG phenylephrine hydrochloride phenylephrine hydrochloride SUPPOSITORY RECTAL 20090301 OTC MONOGRAPH FINAL part346 H and P Industries, Inc. dba Triad Group COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2077; 6; 73 mg/1; mg/1; mg/1 50730-5101_562fdc6a-587d-4751-900f-734dcdf30a22 50730-5101 HUMAN OTC DRUG BZK Antiseptic Towelette benzalkonium chloride SOLUTION TOPICAL 19971017 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .0013 mL/1 50730-5102_4f082dc2-bac8-4d2c-901f-381c65c2e7cc 50730-5102 HUMAN OTC DRUG OB Towelette benzalkonium chloride SOLUTION TOPICAL 19990701 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .004 mL/1 50730-5150_419e24a2-9ce1-4768-871e-79d85ce678a1 50730-5150 HUMAN OTC DRUG BZK Plus Swabsticks benzalkonium chloride SOLUTION TOPICAL 20030210 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .0013 mL/mL 50730-5151_c07da60d-33ca-4cc7-b48a-31c38943e264 50730-5151 HUMAN OTC DRUG BZK Plus Prep Pad benzalkonium chloride SOLUTION TOPICAL 20030210 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .0013 mL/1 50730-5201_9bd7c888-e159-4f13-b98e-4441c315fb14 50730-5201 HUMAN OTC DRUG BZK Towelette benzalkonium chloride SOLUTION EPIDURAL; TOPICAL 19970828 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .0013 mL/1 50730-5400_6eb90f61-5c21-4232-ae64-8d707fca13ee 50730-5400 HUMAN OTC DRUG Relief Towelette witch hazel SOLUTION TOPICAL 19941017 OTC MONOGRAPH FINAL part346 H and P Industries, Inc. dba Triad Group WITCH HAZEL .5 mL/1 50730-7100_96a14e06-0256-4d9f-9c25-e50037177909 50730-7100 HUMAN OTC DRUG Soothing Bath Treatment Colloidal Oatmeal POWDER TOPICAL 19951101 OTC MONOGRAPH FINAL part347 Triad Group OATMEAL 1 g/g 50730-7502_0bc97563-7db2-40b8-b08c-b55acd9baec4 50730-7502 HUMAN OTC DRUG Relief witch hazel SWAB RECTAL; TOPICAL 19970114 OTC MONOGRAPH FINAL part346 H and P Industries, Inc. dba Triad Group WITCH HAZEL .5 mL/1 50730-7503_2ae8f16c-3de6-4ca5-9404-668ea20c9614 50730-7503 HUMAN OTC DRUG Hygienic Cleansing Pad witch hazel SOLUTION RECTAL; TOPICAL 20080301 OTC MONOGRAPH FINAL part346 H and P Industries, Inc. dba Triad Group WITCH HAZEL .5 mL/mL 50730-7549_b0f0c2af-ef39-47ea-b3b4-af08a5c095e8 50730-7549 HUMAN OTC DRUG Medicated Pad witch hazel SOLUTION RECTAL; TOPICAL 20070201 OTC MONOGRAPH FINAL part346 H and P Industries, Inc. dba Triad Group WITCH HAZEL .5 mL/mL 50730-7701_9aa4224e-0160-43a2-80ce-61e177aa757c 50730-7701 HUMAN OTC DRUG Medicated Acne Pads salicylic acid SWAB TOPICAL 20031202 OTC MONOGRAPH FINAL part333D H and P Industries, Inc. dba Triad Group SALICYLIC ACID .02 mL/1 50730-7801_20c9b7f4-9bba-4712-b47f-08805db3013d 50730-7801 HUMAN OTC DRUG Daily Cleansing salicylic acid SWAB TOPICAL 20030831 OTC MONOGRAPH FINAL part333D H and P Industries, Inc. dba Triad Group SALICYLIC ACID .02 mL/1 50730-7993_3ab22487-f897-4f83-aef7-0c6ceae92c95 50730-7993 HUMAN OTC DRUG Medicated Wipes witch hazel SOLUTION TOPICAL 20100413 OTC MONOGRAPH FINAL part346 Triad Group WITCH HAZEL .5 mL/mL 50730-8201_65583b31-de0a-4fd4-a594-2d8a86079f6e 50730-8201 HUMAN OTC DRUG Povidone Iodine Plus povidone-iodine OINTMENT TOPICAL 20010501 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .1 g/g 50730-8204_630e7a63-8a73-4af2-95f8-f8049baacb06 50730-8204 HUMAN OTC DRUG Triadine Prep povidone-iodine SOLUTION TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 Triad Group POVIDONE-IODINE .1 mg/mL 50730-8214_fdf1b647-67ef-48f8-b14a-676ad7cc57e3 50730-8214 HUMAN OTC DRUG Povidone Iodine Plus povidone-iodine GEL TOPICAL 20010401 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .1 g/mL 50730-8230_bce84330-48e5-4544-b2a4-d547dc85ffe6 50730-8230 HUMAN OTC DRUG Povidone Iodine povidone-iodine SOLUTION TOPICAL 20071206 OTC MONOGRAPH NOT FINAL part333A Triad Group POVIDONE-IODINE .1 mg/mL 50730-8304_6919cacc-ec42-4b8e-9bd9-7d3da99eab12 50730-8304 HUMAN OTC DRUG Triadine Scrub povidone-iodine SOLUTION TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 Triad Group POVIDONE-IODINE .075 mL/mL 50730-8308_2eb12584-c65b-4af6-9760-cc554dad229d 50730-8308 HUMAN OTC DRUG Triadine povidone-iodine SOLUTION EPIDURAL; PERCUTANEOUS; TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .075 mL/mL 50730-8316_e85b8e2a-d879-4f02-90e2-da0d0c723bbf 50730-8316 HUMAN OTC DRUG Triadine povidone-iodine SOLUTION EPIDURAL; PERCUTANEOUS; TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .075 mL/mL 50730-8328_1695c60d-5415-49a4-a131-03b212c7d7ab 50730-8328 HUMAN OTC DRUG Triadine povidone-iodine SOLUTION EPIDURAL; PERCUTANEOUS; TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .075 L/L 50730-8332_9bbc5059-f040-4a4c-a293-6f46669b4e62 50730-8332 HUMAN OTC DRUG Triadine povidone-iodine SOLUTION EPIDURAL; PERCUTANEOUS; TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .075 mL/mL 50730-8428_c9cd53bb-0345-49ba-bc38-3762c6ea8391 50730-8428 HUMAN OTC DRUG Triadine Whirlpool povidone-iodine SOLUTION TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .1 L/L 50730-8604_e96d67d0-0edb-4057-83f4-7e00df3bc33e 50730-8604 HUMAN OTC DRUG Antiseptic Hand Gel ethyl alcohol GEL TOPICAL 19971117 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ALCOHOL .7 mL/mL 50730-8608_5edbeea6-d9fc-40c7-ba5e-7e242e3bee4f 50730-8608 HUMAN OTC DRUG Antiseptic Hand Gel ethyl alcohol GEL TOPICAL 19971117 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ALCOHOL .7 mL/mL 50730-8616_9d0fc5ee-99be-4b72-930f-ec3a7245f592 50730-8616 HUMAN OTC DRUG Antiseptic Hand Gel ethyl alcohol GEL TOPICAL 19971117 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ALCOHOL .7 mL/mL 50730-8628_457094d1-02ad-411f-a2ad-fbf42845eafc 50730-8628 HUMAN OTC DRUG Antiseptic Hand Gel ethyl alcohol GEL TOPICAL 19971117 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ALCOHOL .7 L/L 50730-8672_49997a44-d29b-4228-ab6e-c6de0b4133ed 50730-8672 HUMAN OTC DRUG ethyl alcohol ethyl alcohol GEL TOPICAL 19971117 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ALCOHOL .7 g/g 50730-8712_d61fddbc-319f-4531-92ef-fa5629b608f1 50730-8712 HUMAN OTC DRUG Vitamin A and D petrolatum OINTMENT TOPICAL 20011231 OTC MONOGRAPH FINAL part347 H and P Industries, Inc. dba Triad Group PETROLATUM .948 g/g 50730-8717_ac90561d-d907-47ce-b33d-3ff4a422b770 50730-8717 HUMAN OTC DRUG Vitamin A and D petrolatum OINTMENT TOPICAL 20040306 OTC MONOGRAPH FINAL part347 H and P Industries, Inc. dba Triad Group PETROLATUM .948 mL/mL 50730-8719_214a3a07-87f0-4e95-bebc-210cd87aacb5 50730-8719 HUMAN OTC DRUG Vitamin A and D petrolatum OINTMENT TOPICAL 20040306 OTC MONOGRAPH FINAL part347 H and P Industries, Inc. dba Triad Group PETROLATUM .948 mL/mL 50730-8744_2969534a-c2de-458a-90b1-9ffddc685260 50730-8744 HUMAN OTC DRUG Vitamin A and D petrolatum OINTMENT TOPICAL 20011231 OTC MONOGRAPH FINAL part347 H and P Industries, Inc. dba Triad Group PETROLATUM .948 g/g 50742-101_5fde0533-9a35-4d61-9f28-6a314f279bd0 50742-101 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20110130 ANDA ANDA077877 Ingenus Pharmaceuticals, LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50742-102_5fde0533-9a35-4d61-9f28-6a314f279bd0 50742-102 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20110130 ANDA ANDA077877 Ingenus Pharmaceuticals, LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50742-103_5fde0533-9a35-4d61-9f28-6a314f279bd0 50742-103 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20110130 ANDA ANDA077877 Ingenus Pharmaceuticals, LLC ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50742-104_72d6804f-207f-4245-9748-b6001398ca9e 50742-104 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110601 ANDA ANDA078010 Ingenus Pharmaceuticals, LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 50742-105_72d6804f-207f-4245-9748-b6001398ca9e 50742-105 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110601 ANDA ANDA078010 Ingenus Pharmaceuticals, LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 50742-106_72d6804f-207f-4245-9748-b6001398ca9e 50742-106 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110601 ANDA ANDA078010 Ingenus Pharmaceuticals, LLC FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 50742-107_86a3529c-0596-452e-9821-f63ccbeea95e 50742-107 HUMAN PRESCRIPTION DRUG Metoprolol tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20110501 ANDA ANDA078459 Ingenus Pharmaceuticals, LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50742-108_86a3529c-0596-452e-9821-f63ccbeea95e 50742-108 HUMAN PRESCRIPTION DRUG Metoprolol tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20110501 ANDA ANDA078459 Ingenus Pharmaceuticals, LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50742-109_86a3529c-0596-452e-9821-f63ccbeea95e 50742-109 HUMAN PRESCRIPTION DRUG Metoprolol tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20110501 ANDA ANDA078459 Ingenus Pharmaceuticals, LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 50742-123_1529fb2c-81f6-477d-a035-665f4d99657b 50742-123 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20110801 ANDA ANDA090121 Ingenus Pharmaceuticals, LLC FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 50742-137_14f25ebd-62bc-416d-be46-790f6bc70bbb 50742-137 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20120104 ANDA ANDA078155 Ingenus Pharmaceuticals, LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50742-138_14f25ebd-62bc-416d-be46-790f6bc70bbb 50742-138 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20120104 ANDA ANDA078155 Ingenus Pharmaceuticals, LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50742-139_14f25ebd-62bc-416d-be46-790f6bc70bbb 50742-139 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20120104 ANDA ANDA078155 Ingenus Pharmaceuticals, LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50742-140_14f25ebd-62bc-416d-be46-790f6bc70bbb 50742-140 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20120104 ANDA ANDA078155 Ingenus Pharmaceuticals, LLC SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 50742-152_3dded6f4-34af-4e3d-a6bf-b5ecaf5d2882 50742-152 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20140401 ANDA ANDA078963 Ingenus Phamaceuticals, LLC MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 50742-153_3dded6f4-34af-4e3d-a6bf-b5ecaf5d2882 50742-153 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20140401 ANDA ANDA078963 Ingenus Phamaceuticals, LLC MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 50742-154_ca463145-6c91-447c-b2b7-2b9898f22ee6 50742-154 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20140716 ANDA ANDA090564 Ingenus Pharmaceuticals, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 50742-155_ca463145-6c91-447c-b2b7-2b9898f22ee6 50742-155 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20140716 ANDA ANDA090564 Ingenus Pharmaceuticals, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 50742-156_ca463145-6c91-447c-b2b7-2b9898f22ee6 50742-156 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20140716 ANDA ANDA090564 Ingenus Pharmaceuticals, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 50742-207_4ffc402a-df3f-4fb1-85e0-b29f8a3dffb4 50742-207 HUMAN PRESCRIPTION DRUG Tacrolimus tacrolimus CAPSULE ORAL 20120928 ANDA ANDA091195 Ingenus Pharmaceuticals, LLC TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 50742-208_4ffc402a-df3f-4fb1-85e0-b29f8a3dffb4 50742-208 HUMAN PRESCRIPTION DRUG Tacrolimus tacrolimus CAPSULE ORAL 20120928 ANDA ANDA091195 Ingenus Pharmaceuticals, LLC TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 50742-209_4ffc402a-df3f-4fb1-85e0-b29f8a3dffb4 50742-209 HUMAN PRESCRIPTION DRUG Tacrolimus tacrolimus CAPSULE ORAL 20120928 ANDA ANDA091195 Ingenus Pharmaceuticals, LLC TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 50756-100_3281e14a-caeb-4b2b-be96-fd7de4e2d1ad 50756-100 HUMAN OTC DRUG Handex Instant Hand Sanitizer ALCOHOL GEL TOPICAL 20100226 OTC MONOGRAPH FINAL part333 E T Inc. ALCOHOL 62 g/100g 50757-250_f948039e-0c16-46d4-82a3-5ff69ab9efaa 50757-250 HUMAN OTC DRUG Pristall SaniShield Alcohol Free Antiseptic Hand Sanitizer BENZALKONIUM CHLORIDE SPRAY TOPICAL 20100323 OTC MONOGRAPH NOT FINAL part333 Sani Home Products International LLC BENZALKONIUM CHLORIDE .13 mL/100mL 50760-8051_2a638f93-c367-4dfc-a347-9ce9dd0d54a5 50760-8051 HUMAN OTC DRUG DeNino Diaper Rash Rash Prevention Cream CREAM TOPICAL 20100401 OTC MONOGRAPH FINAL part347 Corpsain SA de CV AVENA SATIVA FLOWERING TOP; LANOLIN; MEDIUM-CHAIN TRIGLYCERIDES; ZINC OXIDE .6; 2.4; 18.21; 7.8 mL/60mL; mL/60mL; mL/60mL; mL/60mL 50786-003_01f16fe3-dce6-402d-9dc1-084675f0c93e 50786-003 HUMAN OTC DRUG Valtrum Soothing Topical Analgesic camphor, menthol OINTMENT TOPICAL 20100506 OTC MONOGRAPH FINAL part348 Drogefar C.A. CAMPHOR (SYNTHETIC); MENTHOL 3; 3 mg/100mg; mg/100mg 50788-001_1aa56720-08e1-42ab-b722-24c5f6ed9d15 50788-001 HUMAN OTC DRUG HONIBE MENTHOL LOZENGE ORAL 20120530 OTC MONOGRAPH NOT FINAL part348 Island Abbey Foods Ltd. MENTHOL 8.6 mg/2.5g 50789-436_73ff8c2a-88a7-a5be-b001-c7a1e0d1f46e 50789-436 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20120101 UNAPPROVED MEDICAL GAS Maniilaq Association OXYGEN 930 mL/L 50790-100_a43d8b25-96ec-4daf-8ab8-3958b6765e05 50790-100 HUMAN OTC DRUG Bortons Ethyl Rubbing Alcohol ALCOHOL LIQUID TOPICAL 20100430 OTC MONOGRAPH FINAL part333 J-Mark International Inc. ALCOHOL 82 mL/100mL 50790-200_5539672f-b909-4818-8fb8-91939caa48b6 50790-200 HUMAN OTC DRUG Bortons Menticol Ethyl Alcohol, Menthol LIQUID TOPICAL 20100506 OTC MONOGRAPH FINAL part333 J-Mark International Inc ALCOHOL; MENTHOL 69.5; 1 mL/100mL; mL/100mL 50795-1001_1fdf880e-68aa-4ed0-b49f-90e90ff41f43 50795-1001 HUMAN OTC DRUG U-max Wrinkle Serum ADENOSINE LIQUID TOPICAL 20120604 UNAPPROVED DRUG OTHER VS Shinbi Co., Ltd. ADENOSINE .04 mL/100mL 50795-2001_98c788b5-3dba-461f-aa19-7c2faf9e0c7e 50795-2001 HUMAN OTC DRUG U-max Multi BB ALLANTOIN CREAM TOPICAL 20120604 UNAPPROVED DRUG OTHER VS Shinbi Co., Ltd. ALLANTOIN .1 mL/100mL 50795-3001_5b0043d6-d1b2-4db0-ae40-f50be0148f4e 50795-3001 HUMAN OTC DRUG U-max Whitening Functional Essence ALLANTOIN CREAM TOPICAL 20120604 UNAPPROVED DRUG OTHER VS Shinbi Co., Ltd. ALLANTOIN .1 mL/100mL 50795-4001_50d3b5dc-286a-468b-8857-c9a595a3e093 50795-4001 HUMAN OTC DRUG U-max Beauty CHITOSAN MEDIUM MOLECULAR WEIGHT (200-800 MPA.S) SOAP TOPICAL 20120612 UNAPPROVED DRUG OTHER VS Shinbi Co., Ltd. CHITOSAN MEDIUM MOLECULAR WEIGHT (200-800 MPA.S) 1 g/100g 50802-001_00566b3d-e783-415b-8c96-3b629783aa40 50802-001 HUMAN OTC DRUG SierraSil Pain Relief Camphor SPRAY TOPICAL 20100301 OTC MONOGRAPH FINAL part348 Sierra Mountain Minerals Inc. d/b/a Sierra Sil Health Inc. CAMPHOR OIL 1 mL/30mL 50804-001_1b96c658-3081-48a7-ad7c-d71b2c12e0d3 50804-001 HUMAN OTC DRUG Chocolated Laxative Sennosides Stimulant Laxative TABLET, CHEWABLE ORAL 20131001 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin & Dunn, Inc SENNOSIDES 15 mg/1 50804-002_adf9390b-b234-4b58-8a6e-4af3fe5667ff 50804-002 HUMAN OTC DRUG Stimulant laxative plus stool softener docusate sodium and sennosides TABLET ORAL 20130411 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 50804-005_4b3930b0-23ac-46ae-b171-1067a01a8b9a 50804-005 HUMAN OTC DRUG Stool Softener Gentle DOCUSATE SODIUM CAPSULE ORAL 20100824 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) DOCUSATE SODIUM 100 mg/1 50804-016_56efe535-7ba8-46d2-9505-d706f1f966be 50804-016 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET ORAL 20111115 OTC MONOGRAPH NOT FINAL part343 Geiss, Destin & Dunn, Inc (Goodsense) ACETAMINOPHEN 500 mg/1 50804-076_a7ce504b-c87d-4a9a-b3df-a0a5e726d6d2 50804-076 HUMAN OTC DRUG GoodSense Antibiotic plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Geiss, Destin & Dunn, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g 50804-080_ae67848e-9603-420f-a3ad-f533abb50282 50804-080 HUMAN OTC DRUG GoodSense Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Geiss, Destin & Dunn, Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g 50804-092_c24f818c-c0ed-4e0f-ba4e-e654cfe3daaf 50804-092 HUMAN OTC DRUG Good Sense Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Geiss, Destin & Dunn, Inc. LORATADINE 5 mg/5mL 50804-100_bc8312b2-2ac7-4858-9527-d38d48acd4cc 50804-100 HUMAN OTC DRUG Daytime sinus Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20120710 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 50804-101_e70f403f-42f0-445f-8d79-74272a3a0401 50804-101 HUMAN OTC DRUG Nighttime sinus Acetaminophen, Doxylamine succinate and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20120701 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 50804-107_431b5c0e-5ed7-47f7-a7e5-651b2968faee 50804-107 HUMAN OTC DRUG Mucus Releif Expectorant Guaifenesin TABLET ORAL 20130430 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) GUAIFENESIN 400 mg/1 50804-109_f628770f-7fc4-4761-8a42-6bd6b7746bb0 50804-109 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan Hydrobromide and Guaifenesin TABLET, COATED ORAL 20130430 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 50804-120_dd246c36-350d-4235-9de2-6e3b9d842f95 50804-120 HUMAN OTC DRUG womens laxative Bisacodyl TABLET ORAL 20130416 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) BISACODYL 5 mg/1 50804-140_b1b118a6-957e-43c8-afdc-3081dd908477 50804-140 HUMAN OTC DRUG Laxative pills maximum strength Sennosides TABLET ORAL 20100823 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) SENNOSIDES 25 mg/1 50804-165_ee3c77df-1306-4628-822f-8eb366205eb5 50804-165 HUMAN OTC DRUG Ibuprofen PM Ibuprofen and Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130115 ANDA ANDA090397 Geiss, Destin & Dunn, Inc (Goodsense) DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25; 200 mg/1; mg/1 50804-167_2e195b90-bfaf-4878-aaf8-c0844bc3eb35 50804-167 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20111222 ANDA ANDA079174 Geiss, Destin & Dunn, Inc (Goodsense) IBUPROFEN 200 mg/1 50804-180_714dd62a-30c7-4f0a-9921-2586b5698832 50804-180 HUMAN OTC DRUG Goodsense Senna Sennosides TABLET ORAL 20121102 OTC MONOGRAPH FINAL part334 Geiss, Destin & Dunn, Inc. SENNOSIDES A AND B 8.6 mg/1 50804-183_b1bf0f1a-89f8-49c1-8934-f6b325e73a52 50804-183 HUMAN OTC DRUG Complete Menstrual Relief Acetaminophen, Caffeine, Pyrilamine maleate TABLET ORAL 20120116 OTC MONOGRAPH NOT FINAL part343 Good Sense (Geiss, Destin & Dunn, Inc.) ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 50804-184_5fba2491-9896-4a65-8ae8-07eec28f81cc 50804-184 HUMAN OTC DRUG Headache relief Extra Strength Acetaminophen, Aspirin and Caffeine TABLET ORAL 20120418 OTC MONOGRAPH NOT FINAL part343 Geiss, Destin & Dunn, Inc (Goodsense) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 50804-190_15954078-fd6b-41e5-af97-2a9a037614b3 50804-190 HUMAN OTC DRUG Bisacodyl Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20100716 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) BISACODYL 5 mg/1 50804-191_364172d9-4957-4374-bae3-5835093e7f66 50804-191 HUMAN OTC DRUG Goodsense Oral Pain Relief Benzocaine GEL TOPICAL 20140509 OTC MONOGRAPH FINAL part333B Geiss, Destin and Dunn, Inc. BENZOCAINE 20 g/100g 50804-199_4ce12e37-822c-4a3d-936d-a1eefd1f4cab 50804-199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130423 ANDA ANDA078682 Good Sense (Geiss, Destin & Dunn, Inc.) IBUPROFEN 200 mg/1 50804-200_dbdb4715-3cc0-4808-b779-7c99a54789bb 50804-200 HUMAN OTC DRUG Sleep Aid Regular strength Diphenhydramine HCl TABLET ORAL 20100803 OTC MONOGRAPH FINAL part336 Geiss, Destin & Dunn, Inc (Goodsense) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 50804-217_7399008c-d549-465e-aab6-1cfd850881ca 50804-217 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20130413 ANDA ANDA079174 Good Sense (Geiss, Destin & Dunn, Inc.) IBUPROFEN 200 mg/1 50804-227_16517ce7-f1de-4e07-972d-6ed310999bfe 50804-227 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130315 OTC MONOGRAPH NOT FINAL part343 Geiss, Destin & Dunn, Inc (Goodsense) ASPIRIN 81 mg/1 50804-229_ff02cd73-98c8-4865-8b04-d89ef898a011 50804-229 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130331 OTC MONOGRAPH FINAL part338 Geiss, Destin & Dunn, Inc (Goodsense) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 50804-230_97d2e919-3722-490d-8740-55cf914491f5 50804-230 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20130415 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 50804-236_599ac968-646a-422c-8c90-c8d3eca28c75 50804-236 HUMAN OTC DRUG Nighttime sleep aid Maximum Strength DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 50804-244_9faba0a2-0513-4a96-a1b9-9b4c40627268 50804-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131015 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) DOCUSATE SODIUM 100 mg/1 50804-245_da9ba6b0-9ca4-4ff1-a341-eca78302d662 50804-245 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20131202 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) SENNOSIDES 25 mg/1 50804-247_ab558fca-41e8-4779-b664-d707ba6455b5 50804-247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20131230 OTC MONOGRAPH NOT FINAL part343 Good Sense (Geiss, Destin & Dunn, Inc.) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 50804-252_23fd80de-477b-439c-a02e-cb3efa0fc2d0 50804-252 HUMAN OTC DRUG Sleep Aid Regular Strength Diphenhydramine HCl TABLET ORAL 20140228 OTC MONOGRAPH FINAL part338 Good Sense (Geiss, Destin & Dunn, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 50804-302_26dcbffe-cdc5-4f58-a056-b1405504eb05 50804-302 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140620 ANDA ANDA077958 Good Sense KETOTIFEN FUMARATE .35 mg/mL 50804-352_5013d592-d61d-4096-87f9-4d117e5acb16 50804-352 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20131011 ANDA ANDA201745 Good Sense RANITIDINE HYDROCHLORIDE 75 mg/1 50804-360_f90b22eb-3e90-473a-be0d-ebaec6894128 50804-360 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20121019 OTC MONOGRAPH FINAL part338 Geiss, Destin & Dunn, Inc (Goodsense) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 50804-370_14dc02e5-6e16-451f-8207-3273515e3f7d 50804-370 HUMAN OTC DRUG Enteric coated aspirin Regular strength Aspirin TABLET, COATED ORAL 20110822 OTC MONOGRAPH FINAL part343 Good Sense (Geiss, Destin & Dunn, Inc.) ASPIRIN 325 mg/1 50804-376_3dc1e2cc-fe4f-49f3-a3ce-6f1f0590ef86 50804-376 HUMAN OTC DRUG Sore Throat Phenol SPRAY ORAL 20140930 OTC MONOGRAPH NOT FINAL part356 Good Sense (Geiss, Destin & Dunn, Inc.) PHENOL 1.5 g/100mL 50804-377_95cbb673-036e-4ba7-9330-bf611c1b56b1 50804-377 HUMAN OTC DRUG Sore Throat Phenol SPRAY ORAL 20140930 OTC MONOGRAPH NOT FINAL part356 Good Sense (Geiss, Destin & Dunn, Inc.) PHENOL 1.5 g/100mL 50804-392_1ea5f150-3375-43ff-965e-5077f8349953 50804-392 HUMAN OTC DRUG Itchy Eye Drops Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140620 ANDA ANDA077958 Good Sense KETOTIFEN FUMARATE .35 mg/mL 50804-470_5dfa2691-df89-400b-bc5b-17310269f068 50804-470 HUMAN OTC DRUG Daytime cold and flu relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20110729 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 50804-480_08c3494d-6498-4cfb-94b8-baa960104745 50804-480 HUMAN OTC DRUG Nighttime cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20120701 OTC MONOGRAPH FINAL part341 Geiss, Destin & Dunn, Inc (Goodsense) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 50804-520_76645bfa-7095-4d36-a263-af71851f6eb1 50804-520 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100715 NDA NDA021855 Geiss, Destin & Dunn, Inc (Goodsense) LOPERAMIDE HYDROCHLORIDE 2 mg/1 50804-620_44e5978d-6166-41ee-bf6d-2df7a80fd661 50804-620 HUMAN OTC DRUG Motion sickness less drowsy formula Meclizine HCl TABLET ORAL 20120319 OTC MONOGRAPH FINAL part336 Geiss, Destin & Dunn, Inc (Goodsense) MECLIZINE HYDROCHLORIDE 25 mg/1 50804-630_f87fcc88-8d38-48d7-8185-b19cae8200c7 50804-630 HUMAN OTC DRUG Motion Sickness Original Formula Dimenhydrinate TABLET ORAL 20100810 OTC MONOGRAPH FINAL part336 Good Sense (Geiss, Destin & Dunn, Inc.) DIMENHYDRINATE 50 mg/1 50804-667_8adce681-ea87-4c40-9301-10f6abec63b5 50804-667 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 20090518 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin & Dunn, Inc. MAGNESIUM CITRATE 1.745 g/29.61mL 50804-686_d2a305ed-1422-4516-9a67-74a1f484b8d0 50804-686 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20090518 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin & Dunn, Inc. MAGNESIUM CITRATE 1.745 g/29.61mL 50804-693_c4024fbd-95d2-4adf-87b1-602b15df22ce 50804-693 HUMAN OTC DRUG citroma Magesium Citrate SOLUTION ORAL 20090518 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin & Dunn, Inc. MAGNESIUM CITRATE 1.745 g/29.61mL 50804-720_88f468ff-2727-45f3-a2b3-f4ff2029f337 50804-720 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130606 OTC MONOGRAPH FINAL part336 Good Sense (Geiss, Destin & Dunn, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 50804-804_e688e7f4-bfff-4bba-ac82-31fa6579bc7f 50804-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20110422 OTC MONOGRAPH NOT FINAL part333A Geiss,Destine & Dunn, Inc ISOPROPYL ALCOHOL .91 mg/mL 50804-810_d5e48076-5fbd-4c18-9fb3-55af8f13fda2 50804-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20100408 OTC MONOGRAPH NOT FINAL part333A Geiss, Destin & Dunn, Inc ISOPROPYL ALCOHOL 500 mg/mL 50804-822_4521c2ac-66a3-4d2d-8390-509e3484c060 50804-822 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 20110422 OTC MONOGRAPH FINAL part346 Geiss, Destin & Dunn WITCH HAZEL 979 mg/mL 50804-831_0ac865ec-cc33-4904-b54b-f6ec63a5875b 50804-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 19940805 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin & Dunn, Inc MINERAL OIL 999 mg/mL 50804-845_a9946c06-77c8-4010-8ac6-70a38f71902b 50804-845 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20110422 OTC MONOGRAPH FINAL part344 Geiss, Destin & Dunn, Inc ISOPROPYL ALCOHOL 613 mg/mL 50804-871_6619fc15-1e51-4dc5-a71f-131ccb9aff6d 50804-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19920615 OTC MONOGRAPH NOT FINAL part333A Geiss, Destin & Dunn, Inc HYDROGEN PEROXIDE 30 mg/mL 50804-876_4f8d161b-0e6d-4fa1-b287-1b504be6a484 50804-876 HUMAN OTC DRUG Rubbing Ethyl Alcohol LIQUID TOPICAL 20090518 OTC MONOGRAPH NOT FINAL part333A Geiss, Destin & Dunn, Inc ALCOHOL 610 mg/mL 50809-001_54ea526f-516a-495e-84c8-3f9273d26637 50809-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100517 UNAPPROVED MEDICAL GAS Abilene Oxygen Inc. OXYGEN 99 L/100L 50810-1000_f4605910-cddc-4773-b92a-eceb10bc5d65 50810-1000 HUMAN OTC DRUG Dr. JIs Arthritis Plus camphor, menthol, methyl salicylate GEL TOPICAL 20100504 OTC MONOGRAPH FINAL part348 JI Well Health Company CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 3; 12; 15 mg/100mg; mg/100mg; mg/100mg 50810-2000_22565752-f20c-44f2-80d0-29261781923d 50810-2000 HUMAN OTC DRUG Arthritis Plus Gel Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 JI Well Health Company CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 3; 12; 15 mg/100mg; mg/100mg; mg/100mg 50810-3000_67e24a9c-ff59-4d84-80f1-75cdcb757496 50810-3000 HUMAN OTC DRUG Dr. J.I.s Arthritis Plus Gel Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 JI Well Health Company CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 3; 12; 15 mg/100mg; mg/100mg; mg/100mg 50813-0001_661a107f-8ed3-4b69-8c48-775525795dd7 50813-0001 HUMAN OTC DRUG Bacto Plus Baptisia Tinctoria, Echinacea, Phytolacca Decandra, Aconitum Napellus, Arsenicum Album, Belladonna, Ferrum Phosphoricum LIQUID ORAL 20130912 UNAPPROVED HOMEOPATHIC Dr. Elena M. Morreale, Chiropractic Life Center ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA; ECHINACEA, UNSPECIFIED; FERRUM PHOSPHORICUM; LACHESIS MUTA VENOM; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT 12; 12; 12; 3; 3; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50813-0002_3dbe0d43-d704-4fd6-aabd-b055c5936c39 50813-0002 HUMAN OTC DRUG Bacto Plus HP Apis Mellifica, Arsenicum Album, Belladonna, Chamomilla, Echinacea, Lachesis Mutus, Mercurius Solubilis, Pulsatilla, Pyrogenium LIQUID ORAL 20130912 UNAPPROVED HOMEOPATHIC Dr. Elena M. Morreale, Chiropractic Life Center APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50813-0003_b863749f-b946-4d61-b837-d3bdfa67b02a 50813-0003 HUMAN OTC DRUG Viro Plus Echinacea, Hydrastis Canadensis, Lomatium, Aconitum napellus, Arsenicum Album, Belladonna, Epatorium Perfoliatum, Gelsemium Sempervirens LIQUID ORAL 20130912 UNAPPROVED HOMEOPATHIC Dr. Elena Morreale, Chiropractic Life Center ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; LOMATIUM DISSECTUM ROOT; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3; 12; 3; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50813-0004_ddab4ba4-0e1a-4e4d-9d35-e088c2d0aad0 50813-0004 HUMAN OTC DRUG Fungal Plus Candida Albicans LIQUID ORAL 20130912 UNAPPROVED HOMEOPATHIC Dr. Elena M. Morreale, Chiropractic Life Center CANDIDA ALBICANS 6 [hp_X]/mL 50813-0005_92ecd465-dd1a-4c4f-8523-6324da765af4 50813-0005 HUMAN OTC DRUG Lymph Plus Geranium Robertianum, Nasturtium Aquaticum, Aloe Socotrina, Juglans Regia, Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia LIQUID ORAL 20130912 UNAPPROVED HOMEOPATHIC Dr. Elena M. Morreale, Chiropractic Life Center ALOE; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; CALCIUM SULFIDE; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MERCURIC CYANIDE; MYOSOTIS ARVENSIS; NASTURTIUM AQUATICUM; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; SARSAPARILLA; SCROPHULARIA NODOSA; SODIUM SULFATE; SUS SCROFA PARATHYROID GLAND; SUS SCROFA THYMUS; TEUCRIUM SCORODONIA FLOWERING TOP; THYROID, PORCINE; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 3; 4; 12; 8; 8; 4; 8; 4; 5; 3; 3; 3; 8; 3; 3; 4; 4; 6; 3; 4; 12; 12; 3; 12; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50813-0006_1d652c64-6cd5-440c-b994-572cee7b83c4 50813-0006 HUMAN OTC DRUG Bacto Plus Baptisia tinctoria, Echinacea (Angustifolia), Phytolacca decandra, Aconitum napellus, Arsenicum album, Belladonna, Ferrum phosphoricum, LIQUID ORAL 20140602 UNAPPROVED HOMEOPATHIC Dr. Elena M. Morreale ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; FERRUM PHOSPHORICUM; LACHESIS MUTA VENOM; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT 12; 12; 12; 3; 3; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50813-0007_0588de75-38b3-4e54-969b-9c6e81e54332 50813-0007 HUMAN OTC DRUG Lymph Plus Geranium robertianum, Nasturtium aquaticum, Aloe socotrina, Myosotis arvensis, Scrophularia nodosa, Teucrium socorodonia, Apis mellifica, Equisetum hyemale, LIQUID ORAL 20140621 UNAPPROVED HOMEOPATHIC Dr. Elena M. Morreale ALOE; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; BOS TAURUS PARATHYROID GLAND; CALCIUM SULFIDE; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MERCURIC CYANIDE; MYOSOTIS ARVENSIS; NASTURTIUM AQUATICUM; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; SARSAPARILLA; SCROPHULARIA NODOSA; SODIUM SULFATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 3; 4; 12; 8; 12; 8; 4; 8; 4; 5; 3; 5; 5; 8; 3; 3; 4; 4; 6; 3; 4; 12; 12; 3; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50813-0008_44a1104c-e349-4ce7-bc6b-44efe39dd79f 50813-0008 HUMAN OTC DRUG Fungal Plus NOT APPLICABLE LIQUID ORAL 20140902 UNAPPROVED HOMEOPATHIC Dr Elena Morreale CANDIDA ALBICANS 12 [hp_X]/mL 50813-0009_07761984-a6fd-4057-9a14-b80f74421193 50813-0009 HUMAN OTC DRUG VIRO PLUS NOT APPLICABLE LIQUID ORAL 20140902 UNAPPROVED HOMEOPATHIC Dr Elena M Morreale ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; LOMATIUM DISSECTUM ROOT; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3; 12; 3; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50813-0010_d3cd4436-b4e5-460b-8b9c-94630008c3de 50813-0010 HUMAN OTC DRUG BACTO PLUS HP APIS MELLIFERA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS LIQUID ORAL 20141208 UNAPPROVED HOMEOPATHIC Dr. Elena M. Morreale, Chiropractic Life Center APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50816-624_3a3aa611-f531-489a-99c7-2fbad3b04f86 50816-624 HUMAN PRESCRIPTION DRUG Denavir penciclovir CREAM TOPICAL 20101229 NDA NDA020629 New American Therapeutics, Inc PENCICLOVIR 10 mg/g DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 50819-100_98404e3b-76bf-43a1-8cf5-b21769aef7ab 50819-100 HUMAN OTC DRUG Avalon Premium French Milled TRICLOSAN SOAP TOPICAL 20100524 OTC MONOGRAPH NOT FINAL part333 BNP Industries Inc. TRICLOSAN .2 g/100g 50825-001_b3256bb7-338d-4b08-b64c-36b837329a26 50825-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19370101 UNAPPROVED MEDICAL GAS Zurcare dba Reliable Medical OXYGEN 99 L/100L 50827-002_2910b512-cc87-449b-9529-5e72528df5a3 50827-002 HUMAN OTC DRUG Comfort Alcohol LIQUID TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333A WEIMEI Lianyungang HOUSEHOLD ARTICLES MANUFACTURING CO.LTD ISOPROPYL ALCOHOL 50 mL/100mL 50827-003_88a40cba-e159-4f6e-b8e8-0c7db59769c6 50827-003 HUMAN OTC DRUG Comfort Alcohol LIQUID TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333A WEIMEI Lianyungang Household Articles Manufacturing Co. LTD ISOPROPYL ALCOHOL 50 mL/100mL 50827-650_212d5763-a0ff-4f94-9437-c085502ab098 50827-650 HUMAN OTC DRUG COMFORT HYDROGEN PEROXIDE LIQUID TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part333A Weimei Lianyungang Household Articles manufacturing, Co. LTD HYDROGEN PEROXIDE 2.65 mL/100mL 50844-112_c35c1865-6bbd-4161-b528-894fc5304f91 50844-112 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET ORAL 19810825 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 50844-157_6140df0d-ce83-4676-9073-f136825cbe45 50844-157 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20060210 OTC MONOGRAPH FINAL part343 L.N.K. International, Inc. ASPIRIN 325 mg/1 50844-159_34d6d607-8139-4406-91aa-49de2abca2ca 50844-159 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin and Caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 50844-175_4d7020e8-ef58-4e67-b5ef-baff45f6b0a8 50844-175 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen TABLET ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN 500 mg/1 50844-185_93165ff8-aed8-4326-8355-9d1ea75ccc17 50844-185 HUMAN OTC DRUG Childrens Chewable Pain Reliever Acetaminophen TABLET, ORALLY DISINTEGRATING ORAL 19900410 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN 80 mg/1 50844-190_fa5bb0bf-0938-4755-8e10-f7c00e50b030 50844-190 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part336 L.N.K. International, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 50844-226_5efcc318-42fd-4fdd-b74b-bcd1ec249a72 50844-226 HUMAN OTC DRUG Alert Caffeine TABLET ORAL 19921121 OTC MONOGRAPH FINAL part340 L.N.K. International, Inc. CAFFEINE 200 mg/1 50844-227_bf9d3365-12b9-40d8-9dcd-2b67fa7468dc 50844-227 HUMAN OTC DRUG Regular Strength Enteric Aspirin Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH FINAL part343 L.N.K. International, Inc. ASPIRIN 325 mg/1 50844-235_f753a79b-ec04-4f00-ac20-a16cee426562 50844-235 HUMAN OTC DRUG Extra Strength Pain Reliever PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 50844-249_dca8041f-4a85-40ad-a960-3e7b6f5f8905 50844-249 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19930804 OTC MONOGRAPH FINAL part343 L.N.K. International, Inc. ASPIRIN 325 mg/1 50844-291_b0b0fbb6-50c9-41b1-b6b9-3e462e3c8cb0 50844-291 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990302 ANDA ANDA075010 L.N.K. International, Inc. IBUPROFEN 200 mg/1 50844-292_fb249c81-9449-3bd0-b292-ae9b3c8763fb 50844-292 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990302 ANDA ANDA075010 L.N.K. International, Inc. IBUPROFEN 200 mg/1 50844-293_9ebea0e1-aafd-4001-89c8-073e389d9064 50844-293 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20040408 OTC MONOGRAPH FINAL part336 L.N.K. International, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 50844-329_b8d4d411-1419-42ca-8fa3-f52096d2beee 50844-329 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET, COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 50844-338_3cf0ed8f-c157-4c44-8eaa-a7cf833b8e5e 50844-338 HUMAN OTC DRUG Extra Strength Backache Relief Magnesium Salicylate Tetrahydrate CAPSULE ORAL 19981107 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. MAGNESIUM SALICYLATE 580 mg/1 50844-348_bc9971d0-e69e-4221-9d5e-e581e694a72e 50844-348 HUMAN OTC DRUG Maximum Strength Laxative Sennosides TABLET ORAL 20030104 OTC MONOGRAPH NOT FINAL part334 L.N.K. International, Inc. SENNOSIDES 25 mg/1 50844-352_ae8b992b-0663-292c-faad-eed239126b45 50844-352 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990302 ANDA ANDA075139 L.N.K. International, Inc. IBUPROFEN 200 mg/1 50844-353_1d8e2d8a-59fd-341c-2041-f0ca8508a5fc 50844-353 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990302 ANDA ANDA075139 L.N.K. International, Inc. IBUPROFEN 200 mg/1 50844-375_120f0d03-59f7-4d26-acad-1e3a91eaed74 50844-375 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 L.N.K. International, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 50844-390_46c45dc4-0120-49f1-90b4-8b1895a3ff92 50844-390 HUMAN OTC DRUG Menstrual Relief Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 50844-392_ce9466d7-2e5f-adfb-3d89-f61d7196b950 50844-392 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990302 ANDA ANDA075139 L.N.K. International, Inc. IBUPROFEN 200 mg/1 50844-393_dc6a60a7-f548-db08-f24d-c53c5fa8f588 50844-393 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990302 ANDA ANDA075139 L.N.K. International, Inc. IBUPROFEN 200 mg/1 50844-403_9a552afa-ca3b-4008-8f99-9c121d4d371b 50844-403 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 L.N.K. International, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 50844-411_1b777e46-6a9a-4d6d-894b-3b5e54709553 50844-411 HUMAN OTC DRUG Cough and Cold Relief HBP Chlorpheniramine maleate and Dextromethorphan HBr TABLET ORAL 20030503 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 50844-413_057c89e4-2bfd-4b49-bff8-67f938451cf0 50844-413 HUMAN OTC DRUG Extra Strength Back and Body Aspirin, Caffeine CAPSULE ORAL 20040412 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ASPIRIN; CAFFEINE 500; 32.5 mg/1; mg/1 50844-428_e7726dce-b741-439f-9332-c7d5dc64c964 50844-428 HUMAN OTC DRUG Tension Headache Relief Aspirin Free Acetaminophen, Caffeine TABLET ORAL 20070117 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 50844-438_6a69f041-ec65-fcb0-920e-a8c6b506b422 50844-438 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990302 ANDA ANDA075139 L.N.K. International, Inc. IBUPROFEN 200 mg/1 50844-444_2998c3e6-f6b4-4cf6-b6ea-058004556220 50844-444 HUMAN OTC DRUG Maximum Strength Nasal Decongestant PE Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 50844-466_84dffeff-e438-49c0-8fbd-8eb39d476b67 50844-466 HUMAN OTC DRUG Daytime Sinus Congestion and Pain Acetaminophen and Phenylephrine HCl TABLET ORAL 20050726 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 50844-470_f2264ff0-754d-402c-ace2-865c4e83d3c9 50844-470 HUMAN OTC DRUG Daytime Multi-Symptom Cold Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050715 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 50844-519_fa3a5c4d-411d-4d05-b27e-5c64ec45c25a 50844-519 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN 500 mg/1 50844-529_33a73bd9-7809-4bed-92c1-39462f673269 50844-529 HUMAN OTC DRUG Multi-Symptom Cold Relief Acetaminophen, Chlorpehniramine HCl, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. 50844-532_351329a8-ae1b-4d99-b856-dd055b7aec81 50844-532 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, FILM COATED ORAL 19951222 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. GUAIFENESIN 400 mg/1 50844-548_0f5090b2-3206-4926-b5a8-f519d3a4a19d 50844-548 HUMAN OTC DRUG Sinus Relief PE Maxium Strength Guaifenesin, Phenylephrine HCl TABLET ORAL 20030917 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 200; 5 mg/1; mg/1 50844-600_6bad91f7-e242-4971-8595-2a43b5cd35f6 50844-600 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET ORAL 20110502 OTC MONOGRAPH FINAL part343 L.N.K. International, Inc. ASPIRIN 81 mg/1 50844-607_c2ad9f0e-9028-43df-afcc-fb80f8023c75 50844-607 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET, COATED ORAL 20130401 OTC MONOGRAPH NOT FINAL part334 L.N.K. International, Inc. BISACODYL 5 mg/1 50844-611_5618a886-7518-4afc-93a4-2b8fad3e48a6 50844-611 HUMAN OTC DRUG Ibuprofen PM Diphenhydramine hydrochloride, ibuprofen CAPSULE, LIQUID FILLED ORAL 20130708 ANDA ANDA200888 L.N.K. International, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25; 200 mg/1; mg/1 50844-619_ca09db89-4bd4-4678-8e9b-88c8902c36ee 50844-619 HUMAN OTC DRUG Regular Strength Acid Reducer Ranitidine TABLET ORAL 20130615 ANDA ANDA200536 L.N.K. International, Inc. RANITIDINE HYDROCHLORIDE 75 mg/1 50844-620_d2a5414c-5d5d-4c87-95d7-2dc6e0a13d9e 50844-620 HUMAN OTC DRUG Maximum Strength Acid Reducer Ranitidine TABLET ORAL 20130615 ANDA ANDA200536 L.N.K. International, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 50844-622_6bccb187-aef0-4fa5-badf-60b95f8f0f51 50844-622 HUMAN OTC DRUG Maximum Strength Acid Reducer Famotidine TABLET ORAL 20130801 ANDA ANDA077351 L.N.K. International, Inc. FAMOTIDINE 20 mg/1 50844-664_653f884d-895f-456e-9ae8-a31850d47e06 50844-664 HUMAN OTC DRUG Non-Drowsy Sinus Congestion and Pain Relief Acetaminophen and Phenylephrine HCl TABLET ORAL 20050726 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 50844-732_2d143d62-b2a7-45d1-a671-17b0b95615f5 50844-732 HUMAN OTC DRUG Ibuprofen PM Ibuprofen and Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20120305 ANDA ANDA200888 LNK International, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25; 200 mg/1; mg/1 50844-733_d72628c3-d975-473a-8200-d77989af2d70 50844-733 HUMAN OTC DRUG Mucus Relief Cough Dextromethorphan HBr and Guaifenesin TABLET ORAL 20051231 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 50844-753_f5fda874-d187-4d1c-ae65-a0a040642034 50844-753 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl CAPSULE ORAL 20050503 ANDA ANDA076497 L.N.K. International, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 50844-921_29366b0c-6d6c-4fbc-861a-b04706b7d039 50844-921 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 L.N.K. International, Inc. IBUPROFEN 200 mg/1 50844-932_900276b6-c744-4ee6-a57c-460bc812d84b 50844-932 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE, COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 50844-953_61f102da-c758-43b2-8303-db337c39db7b 50844-953 HUMAN OTC DRUG Nasal Decongestant PE Maximum Strength Non Drowsy Phenylephrine HCl TABLET, FILM COATED ORAL 20050115 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 50845-0002_55762780-6126-42e2-9631-95b71f30a632 50845-0002 HUMAN OTC DRUG Venapro Venapro SPRAY ORAL 20100512 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; CALCIUM FLUORIDE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROCHLORIC ACID; KRAMERIA LAPPACEA ROOT; SILYBUM MARIANUM SEED 3; 10; 3; 1; 1; 6; 3; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0003_08607ee9-3e92-4a09-b8ae-effde3bbe5be 50845-0003 HUMAN OTC DRUG Wartrol Antimoniom crudum, Baptisia tinctoria, Causticum, Nitricum acidum, Thuja occidentalis, SPRAY ORAL 20100916 UNAPPROVED HOMEOPATHIC Liddell Laboratories ANTIMONY TRISULFIDE; BAPTISIA TINCTORIA ROOT; CAUSTICUM; NITRIC ACID; THUJA OCCIDENTALIS LEAFY TWIG 30; 3; 200; 200; 200 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50845-0015_7ce14dbc-92cd-46a1-8c82-e8b213fdef9f 50845-0015 HUMAN OTC DRUG ProBlen HGH HGH, Hepar bovinum, Pituitary bovinum, SPRAY ORAL 20110126 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BEEF LIVER; BOS TAURUS PITUITARY GLAND; SOMATROPIN 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0016_2624391d-3736-43a8-866b-3662670e7766 50845-0016 HUMAN OTC DRUG HGH Complex Arnica montana, Carduus marianus, SPRAY ORAL 20100512 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; ASIAN GINSENG; PHOSPHORIC ACID; PORK LIVER; SILYBUM MARIANUM SEED; SUS SCROFA PITUITARY GLAND 3; 1; 3; 3; 1; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0017_1c45a242-9ddd-445c-9236-27233c5c7f45 50845-0017 HUMAN OTC DRUG Vaginitis Baptisia tinctoria, Kreosotum, Mercurius iodatus ruber, Mercurius sulphuratus ruber, Nitricum acidum, Platinum metallicum, SPRAY ORAL 20110113 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BAPTISIA TINCTORIA ROOT; MERCURIC IODIDE; MERCURIC SULFIDE; NITRIC ACID; PLATINUM; SULFUR IODIDE; SUS SCROFA THYMUS; WOOD CREOSOTE 3; 200; 30; 30; 30; 200; 6; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 50845-0018_78e50e8c-5a41-4add-87d3-07bdf259513e 50845-0018 HUMAN OTC DRUG Acne Anthracinum, Antimonium crudum, Hydrocotyle asiatica, Juglans regia, Kali bromatum, Ledum palustre, Natrum sulphuratum, Pyrogenium, Radium bromatum, Sanguinaria canadensis, Sulphur iodatum, Thuja occidentalis, Urtica urens SPRAY ORAL 20110120 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANTIMONY TRISULFIDE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; CENTELLA ASIATICA; JUGLANS REGIA FLOWERING TOP; LEDUM PALUSTRE TWIG; POTASSIUM BROMIDE; RADIUM BROMIDE; RANCID BEEF; SANGUINARIA CANADENSIS ROOT; SODIUM SULFIDE NONAHYDRATE; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 30; 200; 30; 6; 6; 30; 200; 30; 3; 200; 200; 200; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 50845-0019_65c1a77f-9797-42ed-a76e-44525102fb71 50845-0019 HUMAN OTC DRUG Varicose Veins Aesculus hippocastanum, Arnica montana, Calcarea fluorica, Calcarea iodata, Carduus marianus, Hamamelis virginiana, Hepar suis, Hydrofluoricum acidum, Lachesis mutus, Millefolium, Pulsatilla, SPRAY ORAL 20111118 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACHILLEA MILLEFOLIUM; ARNICA MONTANA; CALCIUM FLUORIDE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROFLUORIC ACID; LACHESIS MUTA VENOM; PORK LIVER; PULSATILLA VULGARIS; SILYBUM MARIANUM SEED 3; 3; 12; 1; 1; 12; 200; 6; 3; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0021_1c8bae8c-a0a0-47f2-8042-d65b203f4978 50845-0021 HUMAN OTC DRUG Cough and Bronchial Antimonium tartaricum, Arsenicum album, Arsenicum iodatum, Arum triphyllum, Baptisia tinctoria, Bryonia, Drosera, Echinacea, SPRAY ORAL 20100902 UNAPPROVED HOMEOPATHIC Liddell Laboratories ANTIMONY POTASSIUM TARTRATE; ARISAEMA TRIPHYLLUM ROOT; ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; LOBARIA PULMONARIA; MERCURIC CHLORIDE; POTASSIUM BROMIDE; SULFUR IODIDE; SUS SCROFA LUNG; URTICA URENS 200; 30; 200; 200; 3; 200; 30; 3; 200; 200; 200; 6; 200; 6; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 50845-0023_8f897153-32bb-4b95-b3ef-1314f49a737a 50845-0023 HUMAN OTC DRUG Yeastrol Baptisia tinctoria, Borax, Candida albicans, Candida parasilosis, Echinacea, Kreosotum, Mercurius cyanatus, SPRAY ORAL 20100727 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BAPTISIA TINCTORIA ROOT; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA; MERCURIC CYANIDE; MERCURIC SULFIDE; NITRIC ACID; RANCID BEEF; SODIUM BORATE; SULFURIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; WOOD CREOSOTE 3; 12; 12; 3; 30; 30; 30; 200; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50845-0025_abef38da-7a2c-463d-b7aa-15cf60fc1cb5 50845-0025 HUMAN OTC DRUG Anit-Inflammatory Aconitum napellus, Apis mellifica, Arnica montana, Cartilage porcine, Hydrastis canadensis, Hypericum perforatum, Rhus toxicodendron, Thuja occidentalis, SPRAY ORAL 20100825 UNAPPROVED HOMEOPATHIC Liddell Laboratories ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; GOLDENSEAL; HYPERICUM PERFORATUM; SUS SCROFA CARTILAGE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 200; 200; 200; 6; 200; 3; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 50845-0027_733b739c-f692-4bd1-90c7-e2491a1ca12b 50845-0027 HUMAN OTC DRUG Poison Oak Ivy Agaricus muscarius, Anacardium orientale, Apis mellifica, Croton tiglium, Cypripedium pubescens, Grindelia, Pyrogenium, Rhus toxicodendron, SPRAY ORAL 20111118 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; APIS MELLIFERA; CROTON TIGLIUM SEED; CYPRIPEDIUM PARVIFOLUM ROOT; GRINDELIA HIRSUTULA FLOWERING TOP; RANCID BEEF; SEMECARPUS ANACARDIUM JUICE; TOXICODENDRON PUBESCENS LEAF 6; 200; 6; 1; 6; 30; 6; 6 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 50845-0029_804b4daa-9822-4f30-88d0-08283cf99850 50845-0029 HUMAN OTC DRUG Pain Aconitum napellus, Arnica Montana, Arsenicum album, Bellis Perennis, Cartilago suis, Causticum, Chamomilla, Coffea cruda, SPRAY ORAL 20101028 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; ARABICA COFFEE BEAN; ARNICA MONTANA; ARSENIC TRIOXIDE; BELLIS PERENNIS; CAUSTICUM; COMFREY ROOT; EUPHORBIA RESINIFERA RESIN; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA TOP; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RANCID BEEF; RANUNCULUS BULBOSUS; SUS SCROFA CARTILAGE 200; 200; 3; 200; 3; 200; 6; 4; 200; 3; 1; 3; 200; 3; 6 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 50845-0031_580863bc-a3c4-4939-939e-8252c7710101 50845-0031 HUMAN OTC DRUG Allergy Allium cepa, Apis mellifica, Aralia racemosa, Arundo mauritanica, Baptisia tinctoria, Echinacea, Euphrasia officinalis, Gelsemium sempervirens, SPRAY ORAL 20100812 UNAPPROVED HOMEOPATHIC Liddell Laboratories APIS MELLIFERA; ARALIA RACEMOSA ROOT; ARUNDO PLINIANA ROOT; BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; ONION; SANGUINARIA CANADENSIS ROOT; SCHOENOCAULON OFFICINALE SEED; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 3; 6; 30; 3; 4; 6; 200; 12; 6; 6; 200; 6; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 50845-0032_b6dddcd6-091a-4e9d-acc6-1cf6cf252f84 50845-0032 HUMAN OTC DRUG Jet Lag Anacardium orientale, Apis mellifica, Carbo vegetabilis, Carduus marianus, Cocculus indicus, Kali phosphoricum, Nux vomica, Passiflora incarnata, Phosphoricum acidum, Tabacum, SPRAY ORAL 20110602 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACTIVATED CHARCOAL; ANAMIRTA COCCULUS SEED; APIS MELLIFERA; PASSIFLORA INCARNATA TOP; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SEMECARPUS ANACARDIUM JUICE; SILYBUM MARIANUM SEED; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 200; 30; 200; 1; 200; 12; 12; 3; 30; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50845-0034_f51a7d3d-70bd-4ddc-b697-1e3444cfcbea 50845-0034 HUMAN OTC DRUG Nicotine Free Abies Nigra, Aconitum Napellus, Arsenicum Iodatum, Avena Sativa, Ignatia Amara, Lung Suis, Nux Vomica, Plantago Major, Quebracho, Sticta Pulmonaria, Tabacum, LIQUID ORAL 20140110 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIIODIDE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; AVENA SATIVA FLOWERING TOP; LOBARIA PULMONARIA; PICEA MARIANA RESIN; PLANTAGO MAJOR; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA LUNG; TOBACCO LEAF 200; 200; 3; 1; 200; 10; 3; 200; 10; 6; 200 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 50845-0035_494b2f10-a9d2-4d1b-a493-e7c80b789f1c 50845-0035 HUMAN OTC DRUG Vital Female Sexual Energy Agnus castus, Arnica montana, Caulophyllum thalictroides, Cinchona officinalis, Damiana, Lactuca virosa, L-arginine, SPRAY ORAL 20100810 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARGININE; ARNICA MONTANA; CAULOPHYLLUM THALICTROIDES ROOT; CHASTE TREE; CINCHONA OFFICINALIS BARK; LACTUCA VIROSA; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; TURNERA DIFFUSA LEAFY TWIG 6; 3; 6; 3; 3; 3; 30; 200; 30; 30; 12; 30; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50845-0036_b6e2d5cd-4b39-457d-9aa0-5d299c8fb2da 50845-0036 HUMAN OTC DRUG Extreme GH Arnica montana, Carduus marianus, Hepar suis, Korean ginseng, Phosphoricum acidum, Pituitary suis, SPRAY ORAL 20100823 UNAPPROVED HOMEOPATHIC Liddell Laboratories ARNICA MONTANA; ASIAN GINSENG; PHOSPHORIC ACID; PORK LIVER; SILYBUM MARIANUM SEED; SUS SCROFA PITUITARY GLAND 1; 1; 1; 4; 1; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0037_d4beb8eb-803b-4ca0-a910-3266e78b0beb 50845-0037 HUMAN OTC DRUG Weight Loss Solution Amino acids, Apis mellifica, Arnica montana, Fucus vesiculosus, Gambogia, Hepar suis, Phosphoricum acidum Pituitary suis, SPRAY ORAL 20100811 UNAPPROVED HOMEOPATHIC Liddell Laboratories AMINO ACIDS; APIS MELLIFERA; ARNICA MONTANA; FUCUS VESICULOSUS; GAMBOGE; PHOSPHORIC ACID; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; THUJA OCCIDENTALIS LEAFY TWIG 6; 4; 3; 3; 3; 3; 6; 24; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 50845-0038_624f5b3e-07c2-49b8-bda7-7a365f1d5678 50845-0038 HUMAN OTC DRUG Vital Male Sexual Energy Arnica montana, Caladium seguinum, Carduus marianus, Damiana, Galium aparine, Glandula suprarenalis suis, Hepar suis, Korean ginseng, SPRAY ORAL 20100810 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc ARNICA MONTANA; ASIAN GINSENG; DIEFFENBACHIA SEGUINE; GALIUM APARINE; LACTUCA VIROSA; NUPHAR LUTEUM ROOT; PHOSPHORIC ACID; POPULUS TREMULOIDES BARK; PORK LIVER; SILYBUM MARIANUM SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA TESTICLE; SUS SCROFA THYMUS; SUS SCROFA THYROID; TESTOSTERONE; THUJA OCCIDENTALIS LEAFY TWIG; TURNERA DIFFUSA LEAFY TWIG 3; 1; 6; 3; 3; 2; 200; 1; 6; 3; 12; 12; 6; 6; 12; 30; 200; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50845-0039_72b40172-e95c-4eae-8fb5-307378896b16 50845-0039 HUMAN OTC DRUG Extreme Thyro pro Amino acids, Apis mellifica, Arnica montana, Fucus vesiculsus, Gambogia, Hepar suis, Phosphoricum acidum, SPRAY ORAL 20100820 UNAPPROVED HOMEOPATHIC Liddell Laboratories AMINO ACIDS; APIS MELLIFERA; ARNICA MONTANA; FUCUS VESICULOSUS; GAMBOGE; PHOSPHORIC ACID; PORK LIVER; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; THYROID 6; 3; 3; 3; 3; 3; 6; 24; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 50845-0041_d16d4dc4-42f2-4136-a45e-422ae76d9e63 50845-0041 HUMAN OTC DRUG Vital HGH Hepar suis, Human Growth Hormone, Pituitary suis, SPRAY ORAL 20100812 UNAPPROVED HOMEOPATHIC Liddell Laboratories PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0042_a3f633cd-6316-4a45-b6a8-fd3ac66f8dea 50845-0042 HUMAN OTC DRUG Brain Energy Arnica montana, Brain suis, Carduus marianus, Cinchona officinalis, Gingko biloba, Lecithin, Millefolium, Phosphoricum acidum, SPRAY ORAL 20100928 UNAPPROVED HOMEOPATHIC Liddell Laboratories ACHILLEA MILLEFOLIUM; ARNICA MONTANA; CINCHONA OFFICINALIS BARK; EGG PHOSPHOLIPIDS; GINKGO; PHOSPHORIC ACID; PORK BRAIN; SILYBUM MARIANUM SEED 3; 3; 6; 12; 6; 30; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 50845-0043_f97677ae-504a-4795-8385-0e38bb4dc0fd 50845-0043 HUMAN OTC DRUG Anger Aconitum napellus, Asafoetida, Chamomilla, Crocus sativus, Hyoscyamus niger, Ignatia amara, Sumbul, Valeriana officinalis, SPRAY ORAL 20100825 UNAPPROVED HOMEOPATHIC Liddell Laboratories ACONITUM NAPELLUS; ASAFETIDA; FERULA SUMBUL ROOT; HYOSCYAMUS NIGER; MATRICARIA RECUTITA; SAFFRON; STRYCHNOS IGNATII SEED; VALERIAN 200; 4; 3; 200; 3; 3; 4; 3 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0044_495f1a2c-6b04-4f5e-a173-29f3dbde906a 50845-0044 HUMAN OTC DRUG Back Pain and Sciatica Aconitum napellus, Arnica montana, Belladonna, Cimicifuga racemosa, Euphorbium officinarum, Gelsemium sempervirens, Gnaphalium polycephalum, Hypericum perforatum, SPRAY ORAL 20110105 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BLACK COHOSH; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF 200; 200; 6; 6; 6; 6; 200; 10; 3; 30; 30; 200 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 50845-0045_527db969-6127-41bc-8205-d830a3cd252b 50845-0045 HUMAN OTC DRUG Metals Alumina, Arsenicum Metallicum, Mercurius Corrosivus, Niccolum Metallicum, Plumbum Metallicum, Radium Bromatum, Stannum Metallicum, LIQUID ORAL 20140102 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ALUMINUM OXIDE; ARSENIC; LEAD; MERCURIC CHLORIDE; NICKEL; RADIUM BROMIDE; TIN 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50845-0046_dde15f43-789f-41b1-abeb-7f5e627a7b06 50845-0046 HUMAN OTC DRUG Snore Defense Antimonium tartaricum, Carbo vegetabilis, Lung suis, Mercurius corrosivus, Quebracho, Sticta pulmonaria, Teucrium marum, SPRAY ORAL 20101015 UNAPPROVED HOMEOPATHIC Liddell Laboratories ACTIVATED CHARCOAL; ANTIMONY POTASSIUM TARTRATE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; LOBARIA PULMONARIA; MERCURIC CHLORIDE; SUS SCROFA LUNG; TEUCRIUM MARUM 12; 200; 3; 200; 200; 6; 3 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 50845-0047_b5d9672c-9c06-47c4-88e4-ffe9d69c40d8 50845-0047 HUMAN OTC DRUG Tension and Anxiety Agnus castus, Avena sativa, Cinchona officinalis, Humulus lupulus, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Valeriana officinalis, SPRAY ORAL 20100811 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. AVENA SATIVA FLOWERING TOP; CHASTE TREE; CINCHONA OFFICINALIS BARK; HOPS; HYOSCYAMUS NIGER; PASSIFLORA INCARNATA TOP; STRYCHNOS IGNATII SEED; VALERIAN 1; 6; 6; 2; 200; 3; 200; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50845-0048_ad483957-f7cc-4e9c-91a0-b34d202e9a4a 50845-0048 HUMAN OTC DRUG Attention Plus Arnica montana, Brain suis, Carduus marianus, Cinchona officinalis, Ginkgo biloba, Lecithin, Millefolium, Phosphoricum acidum, SPRAY ORAL 20101015 UNAPPROVED HOMEOPATHIC Liddell Laboratories ACHILLEA MILLEFOLIUM; ARNICA MONTANA; CINCHONA OFFICINALIS BARK; GINKGO; LECITHIN, SOYBEAN; PHOSPHORIC ACID; PORK BRAIN; SILYBUM MARIANUM SEED 3; 3; 6; 6; 12; 30; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 50845-0050_9a89bca7-6686-4978-9813-763dabc1276a 50845-0050 HUMAN OTC DRUG Loneliness and Sadness Ambra grisea, Argentum nitricum, Aurum metallicum, Avena sativa, Ignatia amara, Melissa officinalis, Sepia, SPRAY ORAL 20100811 UNAPPROVED HOMEOPATHIC Liddell Laboratories AMBERGRIS; AVENA SATIVA FLOWERING TOP; GOLD; MELISSA OFFICINALIS; SEPIA OFFICINALIS JUICE; SILVER NITRATE; STRYCHNOS IGNATII SEED 6; 3; 30; 3; 6; 30; 4 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50845-0053_a3f3a932-7a0d-4bd3-92b4-fcb64fab1c05 50845-0053 HUMAN OTC DRUG Overwhelmed Antimonium crudum, Arsenicum album, Baryta carbonica, Calcarea phosphorica, Calcarea silicata, SPRAY ORAL 20100811 UNAPPROVED HOMEOPATHIC Liddell Laboratories ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; CALCIUM SILICATE; CICUTA VIROSA ROOT; CONIUM MACULATUM FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE 30; 30; 12; 12; 30; 30; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 50845-0056_df782d83-7cff-4352-9c48-536498a6bca6 50845-0056 HUMAN OTC DRUG Brain Power Arnica montana, Brain suis, Carduus marianus, Cinchona officinalis, Ginkgo biloba, HGH, Lecithin, Millefolium, SPRAY ORAL 20101209 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACHILLEA MILLEFOLIUM; ARNICA MONTANA; CINCHONA OFFICINALIS BARK; GINKGO; LECITHIN, SOYBEAN; PHOSPHORIC ACID; PORK BRAIN; SACCHAROMYCES CEREVISIAE RNA; SILICON DIOXIDE; SILYBUM MARIANUM SEED; SOMATROPIN; ZINC SULFATE HEPTAHYDRATE 3; 3; 6; 6; 12; 30; 6; 6; 12; 3; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0057_88234d9f-f373-46c1-a354-d69c00efdd40 50845-0057 HUMAN OTC DRUG Wart Free Antimonium crudum, Baptisia tinctoria, Causticum, Nitricum acidum, Thuja occidentalis, SPRAY ORAL 20110331 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANTIMONY TRISULFIDE; BAPTISIA TINCTORIA ROOT; CAUSTICUM; NITRIC ACID; THUJA OCCIDENTALIS LEAFY TWIG 30; 3; 200; 200; 200 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50845-0058_71d24a96-3945-417f-8e2f-b3a465084c03 50845-0058 HUMAN OTC DRUG Tension Headache Aconitum napellus, Carduus marianus, Coffea cruda, Dioscorea villosa, Gelsemium sempervirens, Gnaphalium polycephalum, Iris versicolor, Passiflora incarnata Stellaria media, Verbascum thapsus, SPRAY ORAL 20110112 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; ARABICA COFFEE BEAN; DIOSCOREA VILLOSA ROOT; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; PASSIFLORA INCARNATA TOP; PSEUDOGNAPHALIUM OBTUSIFOLIUM; SILYBUM MARIANUM SEED; STELLARIA MEDIA; VERBASCUM THAPSUS 200; 200; 3; 3; 3; 2; 3; 3; 3; 3 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0061_614d652e-c16a-4773-8478-a569165cfafe 50845-0061 HUMAN OTC DRUG Weight Loss XL Antimonium crudum, Apis Mellifica, Capsicum annuum, Fucus vesiculosus, Galium aparine, Gambogia, hamamelis virginiana, Hepar suis, Histaminum hydrochloricum, SPRAY ORAL 20100812 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANTIMONY TRISULFIDE; APIS MELLIFERA; CAPSICUM; FUCUS VESICULOSUS; GALIUM APARINE; GAMBOGE; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HISTAMINE DIHYDROCHLORIDE; PETROSELINUM CRISPUM; PORK LIVER; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; SUS SCROFA THYROID; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 1; 3; 3; 30; 3; 200; 3; 12; 30; 12; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50845-0067_371f4da9-329d-4c9f-8be8-1e4b4b62233b 50845-0067 HUMAN OTC DRUG Calcium Plus Alfalfa, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Hydrofluoricum acidum, Shark cartilage, Symphytum officinale, SPRAY ORAL 20110124 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ALFALFA; CALCIUM FLUORIDE; COMFREY ROOT; HYDROFLUORIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SHARK; TRIBASIC CALCIUM PHOSPHATE 1; 30; 30; 30; 200; 10; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 50845-0068_eeeb6bdd-091c-4637-a13e-c7ec55bd6b08 50845-0068 HUMAN OTC DRUG Arthritis Acontium napellus, Apis mellifica, Arnica montana, Berberis vulgaris, Bryonia, Calcarea fluorica. Cimicifuga racemosa, Colchicum autumnale, SPRAY ORAL 20100722 UNAPPROVED HOMEOPATHIC Liddell Laboratories ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; COLCHICUM AUTUMNALE BULB; MERCURIC CHLORIDE; RHODODENDRON AUREUM LEAF; SHARK; SOLANUM DULCAMARA TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; ST. JOHN'S WORT; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 200; 200; 3; 30; 6; 200; 12; 200; 200; 3; 6; 200; 30; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50845-0071_9495f4ab-d6e6-4fc2-b484-3fb6aeafff05 50845-0071 HUMAN OTC DRUG Sinus Congestion Headache Antimonium tartaricum, Arsenicum iodatum, Asafoetida, Baptisia tinctoria, Echinacea, Eupoatorium perfoliatum, Euphorbia pilulifera, Hepar sulphuris calcareum, SPRAY ORAL 20100623 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIIODIDE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA HIRTA; GOLDENSEAL; LACHESIS MUTA VENOM; MERCURIC IODIDE; POTASSIUM DICHROMATE; RANCID BEEF; SILICON DIOXIDE; TEUCRIUM MARUM; WOOD CREOSOTE 6; 200; 30; 3; 30; 3; 3; 3; 30; 200; 200; 30; 200; 30; 3; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 50845-0074_800e85c8-75f8-4cfa-a2ca-9de42434c27f 50845-0074 HUMAN OTC DRUG VITAL II not applicable SPRAY ORAL 20140716 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARGININE; ARNICA MONTANA; ASIAN GINSENG; CERVUS ELAPHUS HORN OIL; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MILK THISTLE; PORK LIVER; SCHISANDRA CHINENSIS FRUIT; SUS SCROFA PITUITARY GLAND; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TURNERA DIFFUSA LEAFY TWIG 6; 3; 3; 6; 3; 3; 3; 6; 3; 30; 3; 200; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50845-0077_a128d081-f790-41c9-b0b7-2e13e8ad9790 50845-0077 HUMAN OTC DRUG Vital HGH Immune Booster Apis mellifica, Borax, Carduus marianus, Echinacea, Galium aparine, Hepar suis, HGH, Mercurius corrosivus, SPRAY ORAL 20100812 UNAPPROVED HOMEOPATHIC Liddell Laboratories APIS MELLIFERA; ECHINACEA; GALIUM APARINE; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; PORK LIVER; SILYBUM MARIANUM SEED; SODIUM BORATE; SOMATROPIN; SULFUR IODIDE; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THUJA OCCIDENTALIS LEAFY TWIG 200; 3; 3; 200; 30; 30; 6; 3; 30; 30; 200; 30; 6; 200 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 50845-0084_1a3eb7cb-f7d0-44bc-9209-8309c4cd615d 50845-0084 HUMAN OTC DRUG HGH-Pro HGH, Hepar suis, Pituitary suis, SPRAY ORAL 20100927 UNAPPROVED HOMEOPATHIC Liddell Laboratories PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0085_6063b633-ea37-4964-8fb5-49a5a82a11fb 50845-0085 HUMAN OTC DRUG Zeta Clear Antimonium crudum, Arsenicum album, Mancinella, Nitricum acidum, Sulphur, Thuja occidentalis, SPRAY ORAL 20100927 UNAPPROVED HOMEOPATHIC Liddell Laboratories ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; NITRIC ACID; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 200; 200; 30; 30; 12; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 50845-0086_c2b6f1fd-0701-47bb-aa17-ce5d0b46ac91 50845-0086 HUMAN OTC DRUG Adrenal and DHEA Aralia quinquefolia, Arnica montana, Avena sativa, Carduus marianus, DHEA, Glandula suprarenalis suis, L-arginine, Natrum muriaticum, Phosphoricum acidum, Thuja occidentalis, Vitamin E, SPRAY ORAL 20101220 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ALPHA-TOCOPHEROL; AMERICAN GINSENG; ARGININE; ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; PHOSPHORIC ACID; PRASTERONE; SILYBUM MARIANUM SEED; SODIUM CHLORIDE; SUS SCROFA ADRENAL GLAND; THUJA OCCIDENTALIS LEAFY TWIG 10; 3; 6; 3; 3; 200; 6; 3; 30; 12; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 50845-0089_5de2aefd-3cad-4a5f-af63-5c204c56a0d9 50845-0089 HUMAN OTC DRUG HGH Human growth hormone, Hepar suis, Pituitary suis, SPRAY ORAL 20110225 20150601 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0092_d77abf86-3bc3-4b24-be68-60eabfb0713e 50845-0092 HUMAN OTC DRUG Menopause Agnus castus, Angelica sinensis radix, Apis mellifica, Aralia quinquefolia, Arnica montana, Cimicifuga racemosa, Galium aparine, Glycyrrhiza glabra, Oophorinum suis, Sepia, Thuja occidentalis, Viscum album, LIQUID ORAL 20140506 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. AMERICAN GINSENG; ANGELICA SINENSIS ROOT; APIS MELLIFERA; ARNICA MONTANA; BLACK COHOSH; CHASTE TREE; GALIUM APARINE; GLYCYRRHIZA GLABRA; SEPIA OFFICINALIS JUICE; SUS SCROFA OVARY; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP 3; 3; 6; 6; 3; 3; 3; 3; 30; 30; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 50845-0095_27bb1eba-d37e-454c-a92a-25b62ecc9e6b 50845-0095 HUMAN OTC DRUG Vital HGH Skin, Hair and Nails Amino acids, Apis mellifica, Biotin, Epidermis, Galium aparine, Hamamelis virginiana, Hepar suis, HGH, Natrum muriaticum, SPRAY ORAL 20100903 UNAPPROVED HOMEOPATHIC Liddell Labroatories AMINO ACIDS; APIS MELLIFERA; BIOTIN; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PANTOTHENIC ACID; PHOSPHORIC ACID; PORK LIVER; RIBOFLAVIN; SODIUM CHLORIDE; SOMATROPIN; SUS SCROFA PITUITARY GLAND; SUS SCROFA SKIN; THUJA OCCIDENTALIS LEAFY TWIG 10; 200; 10; 5; 3; 6; 3; 6; 6; 200; 30; 30; 9; 200 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50845-0099_bf2ed169-9244-402e-a1c6-e385d7fe38e6 50845-0099 HUMAN OTC DRUG Vital Weight Loss HCG Antimonium crudum, Apis mellifica, Capsicum annuum, Fucus vesiculosus, Galium aparine, Gambogia, Hamamelis virginiana, SPRAY ORAL 20101026 UNAPPROVED HOMEOPATHIC Liddell Laboratories ANTIMONY TRISULFIDE; APIS MELLIFERA; CAPSICUM; FUCUS VESICULOSUS; GALIUM APARINE; GAMBOGE; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HISTAMINE DIHYDROCHLORIDE; HUMAN CHORIONIC GONADOTROPIN; PETROSELINUM CRISPUM; PORK LIVER; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; SUS SCROFA THYROID; THUJA OCCIDENTALIS LEAFY TWIG 8; 6; 6; 1; 3; 3; 30; 3; 200; 60; 3; 12; 30; 12; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50845-0100_cfa27334-778a-482b-93c9-b6b7f2988b02 50845-0100 HUMAN OTC DRUG Morning Sickness Symphoricarpus racemosus, SPRAY ORAL 20110524 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. SYMPHORICARPOS ALBUS FRUIT 30 [hp_C]/mL 50845-0101_4497611f-0fe2-42a4-9357-2ed375123dc3 50845-0101 HUMAN OTC DRUG Candida Yeast Baptisia tinctoria, Borax, Candida albicans, Candida parapsilosis, Echinacea, Kreosotum, Mercurius cyanatus, Mercurius sulphuratus ruber, Nitricum acidum, SPRAY ORAL 20101018 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BAPTISIA TINCTORIA ROOT; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA, UNSPECIFIED; MERCURIC CYANIDE; MERCURIC SULFIDE; NITRIC ACID; RANCID BEEF; SODIUM BORATE; SULFURIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; WOOD CREOSOTE 3; 12; 12; 3; 30; 30; 30; 200; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50845-0102_d2286f38-b277-4f17-95f3-bdcf104ddd2b 50845-0102 HUMAN OTC DRUG Stomach Distress Arsenicum album, Calcarea sulphurica, Carbo animalis, Carbo vegetabilis, Cinchona officinalis, Hydrastis canadensis, Nux vomica, Ornithogalum umbellatum, Pyrogenium, Silicea, SPRAY ORAL 20110726 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; CALCIUM SULFATE ANHYDROUS; CARBO ANIMALIS; CINCHONA OFFICINALIS BARK; GOLDENSEAL; ORNITHOGALUM UMBELLATUM; RANCID BEEF; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED 12; 200; 200; 12; 200; 12; 12; 200; 12; 200 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 50845-0103_1be1533e-07e3-4da1-a354-925ff1741ca7 50845-0103 HUMAN OTC DRUG Incontinence Belladonna, Cantharis, Causticum, Cina, Equisetum hyemale, Ignatia amara, Physalis alkekengi, Sepia, Uranium nitricum, Verbascum thapsus, SPRAY ORAL 20140512 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARTEMISIA CINA PRE-FLOWERING TOP; ATROPA BELLADONNA; CAUSTICUM; EQUISETUM HYEMALE; LYTTA VESICATORIA; PHYSALIS ALKEKENGI FRUIT; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; URANYL NITRATE HEXAHYDRATE; VERBASCUM THAPSUS 6; 200; 200; 3; 200; 3; 200; 200; 12; 3 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 50845-0104_fd7eca6f-5bd8-45b5-a0fa-2add93805de1 50845-0104 HUMAN OTC DRUG EMF Arnica montana, Arsenicum album, Baptisia tinctoria, Cinchona officinalis, Galium aparine, Hepar suis, Korean ginseng, Mercurius corrosivus, Phosphoricum acidum, Radium bromatum, Sulphur iodatum, Thuja occidentalis, X-ray, SPRAY ORAL 20110624 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ALCOHOL, X-RAY EXPOSED (1000 RAD); ARNICA MONTANA; ARSENIC TRIOXIDE; ASIAN GINSENG; BAPTISIA TINCTORIA ROOT; CINCHONA OFFICINALIS BARK; GALIUM APARINE; MERCURIC CHLORIDE; PHOSPHORIC ACID; PORK LIVER; RADIUM BROMIDE; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG 200; 3; 200; 1; 3; 6; 3; 200; 3; 6; 200; 200; 200 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50845-0106_5e3897e7-0f5e-4dc2-9304-f06b2ed70e6c 50845-0106 HUMAN OTC DRUG Diuretic Apis Melifica, Berberis vulgaris, Nelleborus niger, Juniperus communis, Prunus spinosa, Strophanthus hispidus, Taraxacum offidcinale, Uva-Ursi, SPRAY ORAL 20121126 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; HELLEBORUS NIGER ROOT; JUNIPERUS COMMUNIS WHOLE; PRUNUS SPINOSA FLOWER BUD; STROPHANTHUS HISPIDUS SEED; TARAXACUM OFFICINALE 3; 3; 3; 3; 1; 3; 6; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0108_4f3cb937-6514-46e6-b09d-d9aa93ef1594 50845-0108 HUMAN OTC DRUG Insomnia Aquilegia vulgaris, Avena sativa, Chamomilla, Coffea cruda, Cypripedium pubescens, Humulus lupulus, Hypericum perforatum, Kali phosphoricum, SPRAY ORAL 20121204 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. AQUILEGIA VULGARIS; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; CYPRIPEDIUM PARVIFOLUM ROOT; HYPERICUM PERFORATUM; MATRICARIA CHAMOMILLA WHOLE; MELATONIN; MELISSA OFFICINALIS; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; VALERIAN 2; 6; 2; 3; 3; 2; 6; 3; 2; 12; 30; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50845-0109_c088daff-b9a7-436c-80da-1d6bbf8c4550 50845-0109 HUMAN OTC DRUG PMS Apis mellifica, Chamomilla, Cimicifuga racemosa, Cuprum metallicum, Ignatia amara, Kali iodatum, Magnesia phosphorica, Oophorinum, Platinum metallicum, Sepia, Thuja occidentalis, SPRAY ORAL 20110718 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; BLACK COHOSH; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; PLATINUM; POTASSIUM IODIDE; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; SUS SCROFA OVARY; THUJA OCCIDENTALIS LEAFY TWIG 200; 6; 12; 9; 12; 12; 200; 9; 6; 30; 200 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 50845-0110_438b141d-a568-4006-8afa-24e9443d0412 50845-0110 HUMAN OTC DRUG Bladder UTI Apis Mellifica, Arsenicum Iodatum, Berberis Vulgaris, Cantharis, Coccus Cacti, Echinacea, Mercurius Corrosivus LIQUID ORAL 20121127 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIIODIDE; BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA; GINGER; LYTTA VESICATORIA; MERCURIC CHLORIDE; PROTORTONIA CACTI; RUBIA TINCTORUM ROOT; THUJA OCCIDENTALIS LEAF 200; 200; 6; 1; 6; 200; 200; 3; 1; 200 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 50845-0112_98f318a4-d619-401d-8989-792aceeab10e 50845-0112 HUMAN OTC DRUG Asthma Arsenicum iodatum, Blatta orientalis, Bryonia, Carbo vegetabilis, Eupatorium perfoliatum, Histaminum hydrochloricum, Ipecacuanha, Lung suis, SPRAY ORAL 20101103 UNAPPROVED HOMEOPATHIC Liddell Laboratories ACTIVATED CHARCOAL; ARSENIC TRIIODIDE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; BLATTA ORIENTALIS; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUROPEAN ELDERBERRY; HISTAMINE DIHYDROCHLORIDE; IPECAC; LOBARIA PULMONARIA; MERCURIC CHLORIDE; SODIUM SULFATE; SUS SCROFA LUNG; URTICA URENS 12; 200; 3; 30; 6; 6; 3; 200; 4; 200; 200; 30; 6; 200 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 50845-0113_ab1db44b-9486-46f6-bb00-0fb3c26a946b 50845-0113 HUMAN OTC DRUG Testosterone Avena sativa, Carduus marianus, Damiana, Galium aparine, Hamamelis virginiana, Hepar bovinum, Korean ginseng, Nuphar luteum, Orchitinum bovinum, SPRAY ORAL 20101227 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ASIAN GINSENG; AVENA SATIVA FLOWERING TOP; BEEF LIVER; BOS TAURUS TESTICLE; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; NUPHAR LUTEUM ROOT; POPULUS TREMULOIDES BARK; SILYBUM MARIANUM SEED; TESTOSTERONE; THUJA OCCIDENTALIS LEAFY TWIG; TURNERA DIFFUSA LEAFY TWIG 1; 1; 6; 6; 3; 1; 2; 1; 1; 30; 200; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50845-0114_60d13e63-4775-430d-9bdb-7b496635b426 50845-0114 HUMAN OTC DRUG Immune Booster Apis mellifica, Borax, Carduus marianus, Echanacea, Galium aparine, Hepar suis, HGH, Mercurius corrosivus, Mercurius sulphuratus ruber, Nitricum acidum, Pituitary suis, Sulphur iodatum, Thua occidenta SPRAY ORAL 20101215 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; ECHINACEA; GALIUM APARINE; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; PORK LIVER; SILYBUM MARIANUM SEED; SODIUM BORATE; SOMATROPIN; SULFUR IODIDE; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THUJA OCCIDENTALIS LEAFY TWIG 200; 3; 3; 200; 30; 30; 6; 3; 30; 30; 200; 30; 6; 200 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 50845-0119_d389e186-5711-470d-8b51-79a9438b1a8a 50845-0119 HUMAN OTC DRUG Earache Aconitum napellus, Anthracinum, Arnica montana, Baptisia tinctoria, Capsicum annuum, Chamomilla, Chenopodium anthelminticum, Euphorbium officinarum, Lachesis mutus, Magnesia phosphorica, SPRAY ORAL 20110125 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; CAPSICUM; CHAMOMILE; CHENOPODIUM AMBROSIOIDES; EUPHORBIA RESINIFERA RESIN; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIC CHLORIDE; PLANTAGO MAJOR; PULSATILLA VULGARIS; VERBASCUM THAPSUS 200; 200; 200; 3; 6; 3; 4; 4; 200; 8; 200; 3; 30; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0120_59528a53-928c-444c-a145-f8e509458b81 50845-0120 HUMAN OTC DRUG Canker and Cold Sore Apis mellifica, Arsenicum album, Baptisia tinctoria, Borax Capsicum annuum, Dulcamara, Echinacea, Mercurius corrosivus, Nitricum acidum, Pyrogenium, Rhus toxicodendron, Sulphur iodatum, Thuja occ iden SPRAY ORAL 20110112 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CAPSICUM; ECHINACEA; MERCURIC CHLORIDE; NITRIC ACID; RANCID BEEF; SODIUM BORATE; SOLANUM DULCAMARA TOP; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 3; 200; 3; 6; 3; 200; 200; 200; 200; 30; 200; 200; 200 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50845-0121_5e47d36b-c1f0-4026-9ea5-7dace7d1b088 50845-0121 HUMAN OTC DRUG Delivery Support Caulphyllum thalictroides, Pulsatilla, Sepia, SPRAY ORAL 20110113 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc CAULOPHYLLUM THALICTROIDES ROOT; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 30; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50845-0122_03ee1d0d-f9e4-4698-8189-d023dc455294 50845-0122 HUMAN OTC DRUG Teething Aconitum napellus, Belladonna, Borax, Calcarea phosphorica, Chamomilla, Kali phosphoricum, Magnesia phosphorica, Nitricum acidum, Staphysagria, LIQUID ORAL 20110125 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; CHAMOMILE; DELPHINIUM STAPHISAGRIA SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; NITRIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SODIUM BORATE; TRIBASIC CALCIUM PHOSPHATE 30; 30; 3; 9; 8; 30; 6; 30; 8 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50845-0123_33575489-1a92-415e-ba61-be28f901e617 50845-0123 HUMAN OTC DRUG ProBLEN Libido Damiana, Galium aparine, Glandula suprarenalis bovinum, Hepar bovinum, Korean ginseng, Nuphar luteum, Orchitinum bovinum, Phosphoricum acidum, Pituitary bovinum, Populus tremuloides, Testosterone, SPRAY ORAL 20110126 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ASIAN GINSENG; BEEF LIVER; BOS TAURUS ADRENAL GLAND; BOS TAURUS PITUITARY GLAND; BOS TAURUS TESTICLE; GALIUM APARINE; NUPHAR LUTEUM ROOT; PHOSPHORIC ACID; POPULUS TREMULOIDES LEAF; TESTOSTERONE; TURNERA DIFFUSA LEAFY TWIG 1; 6; 12; 12; 6; 3; 2; 200; 3; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0124_c21efaa6-752d-4e5f-b973-d36834b8c18d 50845-0124 HUMAN OTC DRUG Appetite Increase Alfalfa, Avena sativa, Oleum morrhuae, SPRAY ORAL 20110328 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; COD LIVER OIL 1; 1; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0125_4a74c264-9aa8-4305-9a9b-a6d1618a68e3 50845-0125 HUMAN OTC DRUG Hemorrhoid Relief Aesculus hippocastanum, Arnica Montana, Calcarea fluorica, Carduus marianus, Collinsonia canadensis, Hamamelis virginiana, Muriaticum acidum, Ratanhia, SPRAY ORAL 20110328 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CALCIUM FLUORIDE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; KRAMERIA LAPPACEA ROOT; SILYBUM MARIANUM SEED 1; 3; 9; 3; 1; 6; 3; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0126_091d0441-511d-49f9-865b-45abda5cbbbb 50845-0126 HUMAN OTC DRUG Herpeset Apis mellifica, Arsenicum album, Baptisia tinctoria, Capsicum annuum, Dulcamara, Echinacea, Nitricum acidum, Pyrogenium, Rhus toxicodendron, SPRAY ORAL 20110707 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CAPSICUM; ECHINACEA; NITRIC ACID; RANCID BEEF; SOLANUM DULCAMARA FLOWER; TOXICODENDRON PUBESCENS LEAF 3; 200; 3; 6; 3; 200; 200; 30; 200 [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50845-0127_adf30e28-8f5d-4530-8155-924f9b71fbaa 50845-0127 HUMAN OTC DRUG CHEMICALS Arsnicum Album, Carduus Marianus, Hepar Suis, Lung Suis, Pancreas Suis, Radium Bromatum, Serum Anguillae, Terebinthina SPRAY ORAL 20130731 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ALCOHOL, X-RAY EXPOSED (1000 RAD); ANGUILLA ROSTRATA BLOOD SERUM; ARSENIC TRIOXIDE; GINGER; PORK LIVER; RADIUM BROMIDE; SILYBUM MARIANUM SEED; SUS SCROFA LUNG; SUS SCROFA PANCREAS; TURPENTINE OIL 200; 30; 200; 6; 6; 200; 3; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0128_1e5b3238-94f3-49b9-b377-f219705fa6a4 50845-0128 HUMAN OTC DRUG Vaccines Detox Arnica montana, Mercurius corrosivus, Sulphur iodatum, Thuja occidentalis, Urtica urens, SPRAY ORAL 20110404 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; MERCURIC CHLORIDE; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 3; 200; 200; 200; 3 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 50845-0129_a69d5a27-b4f6-41c8-a293-5ef88c187b18 50845-0129 HUMAN OTC DRUG Alcohol Safeguard Carboneum sulphuratum, Carduus marianus, Ceanothus americanus, Hepar suis, Pancreas suis, Quercus glandium spitirus, Ranunculus bulbosus, SPRAY ORAL 20110412 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CARBON DISULFIDE; CEANOTHUS AMERICANUS LEAF; PORK LIVER; QUERCUS ROBUR NUT; RANUNCULUS BULBOSUS; SILYBUM MARIANUM SEED; SUS SCROFA PANCREAS 6; 30; 6; 3; 3; 1; 6 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0130_acecfee9-b0aa-4d83-84ba-a60aa6d9ad88 50845-0130 HUMAN OTC DRUG Tinnitus Control Arnica montana, Chininum sulphuricum, Ferrum metallicum, Kali phosphoricum, Natrum sulphuricum, Pulsatilla, Silicea, Thiosinaminum, SPRAY ORAL 20110426 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ALLYLTHIOUREA; ARNICA MONTANA; IRON; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; QUININE SULFATE; SILICON DIOXIDE; SODIUM SULFATE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0131_acf9555d-7ec3-4476-bddb-53dec43708e1 50845-0131 HUMAN OTC DRUG Eazol Aconitum napellus, Arsenicum album, Coffea cruda, Euphorbium officinarum, Gnaphalium polycephalum, Hypericum perforatum, Magnesia phosphorica, Passiflora incarnata, Ranunculus bulbosus, SPRAY ORAL 20110415 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; EUPHORBIA RESINIFERA RESIN; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PASSIFLORA INCARNATA TOP; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RANUNCULUS BULBOSUS 200; 200; 200; 4; 200; 12; 1; 3; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0132_7f4ece5c-ea1f-4057-ae27-af1f05a50cb0 50845-0132 HUMAN OTC DRUG ProBlen DNA RNA Rejuvenation Arnica montana, Avena sativa, Damiana, DNA, Korean ginseng, Oleum animale, Pituitary bovinum, RNA, Thuja occidentalis, Tribulus terrestris, SPRAY ORAL 20110412 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; ASIAN GINSENG; AVENA SATIVA FLOWERING TOP; BOS TAURUS PITUITARY GLAND; CERVUS ELAPHUS HORN OIL; HERRING SPERM DNA; SACCHAROMYCES CEREVISIAE RNA; THUJA OCCIDENTALIS LEAFY TWIG; TRIBULUS TERRESTRIS ROOT; TURNERA DIFFUSA LEAFY TWIG 6; 3; 3; 5; 6; 9; 9; 6; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0133_1f299780-b7a8-4f3e-9ab8-c49ee7b59cec 50845-0133 HUMAN OTC DRUG GH Hepar suis, HGH, Pituitary suis, SPRAY ORAL 20110620 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0134_3dd4f4a5-fc1d-4d8b-a956-4643bd106296 50845-0134 HUMAN OTC DRUG Miracet Abies nigra, Aconitum napellus, Arsenicum iodatum, Avena sativa, Ignatia amara, Lung suis, Nux vomica, Plantago major, Quebracho, Sticta pulmonaria, Tabacum, SPRAY ORAL 20110624 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIIODIDE; AVENA SATIVA FLOWERING TOP; LOBARIA PULMONARIA; PICEA MARIANA RESIN; PLANTAGO MAJOR; QUEBRACHO BARK; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA LUNG; TOBACCO LEAF 200; 200; 1; 200; 10; 3; 3; 200; 10; 6; 200 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 50845-0135_6acc577b-b894-422a-bc94-c09b15a1a98a 50845-0135 HUMAN OTC DRUG Insect Bites Anthracinum, Apis Mellifica, Arnica Montana, Calendula Officinalis, Conium Maculatum, Echinacea (Angustifolia), Euphorbia Pilulifera, Grindelia, Histaminum Hydrochloricum, Hypericum perforatum, Lachesis Mutus, Latrodectus Mactans, Ledum Palustre, Pyrogenium, Tarentula Cubensis LIQUID ORAL 20140707 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; ARNICA MONTANA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; CALENDULA OFFICINALIS FLOWERING TOP; CITHARACANTHUS SPINICRUS; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; EUPHORBIA HIRTA FLOWERING TOP; GRINDELIA HIRSUTULA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; RANCID BEEF 3; 200; 200; 3; 10; 200; 3; 4; 6; 12; 6; 200; 30; 6; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 50845-0136_21fd8db3-9b5b-464f-9af0-ebde5623fc26 50845-0136 HUMAN OTC DRUG Herpes Simplex Apis mellifica, Arsenicum album, Baptisia tinctoria, Capsicum annuum, Dulcamara, Echinacea, Nitricum acidum, Pyrogenium, Rhus toxicodendron, SPRAY ORAL 20110609 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CAPSICUM; ECHINACEA, UNSPECIFIED; NITRIC ACID; RANCID BEEF; SOLANUM DULCAMARA FLOWER; TOXICODENDRON PUBESCENS LEAF 3; 200; 3; 6; 3; 200; 200; 30; 200 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50845-0137_65800bfb-76c2-4186-ae84-fc68f23ec51f 50845-0137 HUMAN OTC DRUG Anti Inflammatory Aconitum napellus, Apis mellifica, Arnica montana, Cartilago suis, Hydrastis canadensis, Hypericum perforatum, Rhus toxicodendron, Thuja occidentalis, SPRAY ORAL 20110617 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; GOLDENSEAL; HYPERICUM PERFORATUM; SUS SCROFA CARTILAGE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 200; 200; 200; 6; 200; 6; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 50845-0138_008d2cb1-f8ff-4f95-9e75-d8ddedf2ecee 50845-0138 HUMAN OTC DRUG ProBLEN Estrogen and Progesterone Agnus castus, Angelica sinesis, radix, Apis mellifica, Arnica montana, Cimicifuga racemosa, Estradiol, Estriol, Folliculinum, Galium aparine, SPRAY ORAL 20101221 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANGELICA SINENSIS ROOT; APIS MELLIFERA; ARNICA MONTANA; ASIAN GINSENG; BLACK COHOSH; BOS TAURUS OVARY; CHASTE TREE; ESTRADIOL; ESTRIOL; ESTRONE; GALIUM APARINE; GLYCYRRHIZA GLABRA; PROGESTERONE; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP 3; 6; 6; 3; 3; 30; 3; 9; 9; 9; 3; 3; 6; 30; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 50845-0150_efdcce5b-d819-4bbb-a3d8-fb152e942bb1 50845-0150 HUMAN OTC DRUG Vital Weight Loss XL Antimonium Crudum, Apis Mellifica, Capsicum Annuum, Fucus Vesiculosus, Galium Aparine, Gambogia, Hamamelis Virginiana, Hepar Suis, Histaminum Hydrochloricum, Nux Vomica, Pancreas Suis, Petroselinum Sativum, LIQUID ORAL 20131025 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANTIMONY TRISULFIDE; APIS MELLIFERA; CAPSICUM; FUCUS VESICULOSUS; GALIUM APARINE; GAMBOGE; GINGER; HAMAMELIS VIRGINIANA BARK; HISTAMINE DIHYDROCHLORIDE; PETROSELINUM CRISPUM; PORK LIVER; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; SUS SCROFA THYROID; THUJA OCCIDENTALIS LEAF 8; 6; 6; 1; 3; 3; 30; 3; 200; 3; 12; 30; 12; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50845-0151_4b9c06c6-96b9-4cc8-b75d-0b34c0c4afc8 50845-0151 HUMAN OTC DRUG Motion Sickness Cocculus indicus, Hepar suis, Nux vomica, Petroleum, Phosphoricum acidum, Tabacum, SPRAY ORAL 20110617 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANAMIRTA COCCULUS SEED; LIQUID PETROLEUM; PHOSPHORIC ACID; PORK LIVER; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 200; 6; 200; 6; 6; 6 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0152_22a7da11-423b-4485-9425-349b7b303ea9 50845-0152 HUMAN OTC DRUG Attention Plus Arnica montana, Brain suis, Carduus marianus, Cinchona officinalis, Ginkgo biloba, Lecithin, Millefolium, Phosphoricum acidum, SPRAY ORAL 20110620 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACHILLEA MILLEFOLIUM; ARNICA MONTANA; CINCHONA OFFICINALIS BARK; GINKGO; LECITHIN, SOYBEAN; PHOSPHORIC ACID; PORK BRAIN; SILYBUM MARIANUM SEED 3; 3; 6; 6; 12; 30; 4; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 50845-0163_8b7f8835-cb0b-455e-b573-0def5c5fe3c2 50845-0163 HUMAN OTC DRUG Party Detox Arsenicum album, Avena sativa, Bryonia, Carbo animalis, Carduus marianus, Chelidonium majus, Hepar suis, Kali iodatum, Lapis albus, Nux vomica, Radium bromatum, Taraxacum officinale, Thuja occidentalis, SPRAY ORAL 20111003 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BRYONIA ALBA ROOT; CALCIUM HEXAFLUOROSILICATE; CARBO ANIMALIS; CHELIDONIUM MAJUS; MILK THISTLE; PORK LIVER; POTASSIUM IODIDE; RADIUM BROMIDE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG 200; 1; 200; 200; 200; 200; 1; 6; 200; 200; 30; 1; 200 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 50845-0167_d5985361-8141-4b85-9b59-177397e718ca 50845-0167 HUMAN OTC DRUG DNA RNA Spectrum Alanine, Arginine, Asparagine, Aspartate, Cysteine, Glutamate, Glutamine, Glycine, Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Proline, Serine, Threonine, Tyrosine, Tryptophan, SPRAY ORAL 20110929 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ALANINE; ARGININE; ASIAN GINSENG; ASPARAGINE; ASPARTIC ACID; AVENA SATIVA FLOWERING TOP; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; CHLORELLA VULGARIS; CYSTEINE; FERRUM PHOSPHORICUM; GLUTAMINE; GLYCINE; HERRING SPERM DNA; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; METHIONINE; MONOSODIUM GLUTAMATE ANHYDROUS; NUPHAR LUTEUM ROOT; PHENYLALANINE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; PROLINE; SACCHAROMYCES CEREVISIAE RNA; SELENIUM; SERINE; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; SOMATROPIN; SPIRULINA PLATENSIS; THREONINE; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE; TRYPTOPHAN; TURNERA DIFFUSA LEAFY TWIG; TYROSINE; VALINE; ZINC 6; 6; 3; 6; 6; 3; 8; 8; 6; 6; 8; 6; 6; 6; 6; 6; 6; 6; 8; 6; 6; 3; 6; 8; 8; 8; 6; 6; 8; 6; 8; 8; 8; 8; 24; 6; 6; 200; 8; 6; 3; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0168_f8c02c86-4d06-4eae-9ba0-93b3a6c1a563 50845-0168 HUMAN OTC DRUG Air Pollution Detox Argentum nitricum, Arsenicum album, Carduus marianus, Hepar suis, Lung suis, Mercurius corrosivus, Plumbum metallicum, SPRAY ORAL 20121204 UNAPPROVED HOMEOPATHIC Liddell Laboratoriess, Inc. ARSENIC TRIOXIDE; LEAD; MERCURIC CHLORIDE; PORK LIVER; SILVER NITRATE; SILYBUM MARIANUM SEED; SUS SCROFA LUNG 200; 200; 200; 6; 200; 1; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 50845-0169_4f9a3695-892c-43f8-a910-e37c93a86b9a 50845-0169 HUMAN OTC DRUG ProBLEN Estrogen and Progesterone Agnus castus, Angelica sinensis, radix, Apis mellifica, Arnica montana, Cimicifuga racemosa, Estradiol, Estriol, Folliculinum, Galium aparine, Glycyrrhiza glabra, Korean ginseng, SPRAY ORAL 20120131 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANGELICA SINENSIS ROOT; APIS MELLIFERA; ARNICA MONTANA; ASIAN GINSENG; BLACK COHOSH; CHASTE TREE; ESTRADIOL; ESTRIOL; ESTRONE; GALIUM APARINE; GLYCYRRHIZA GLABRA; PROGESTERONE; SEPIA OFFICINALIS JUICE; SUS SCROFA OVARY; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP 3; 6; 6; 3; 3; 3; 9; 9; 9; 3; 3; 6; 30; 30; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 50845-0172_abf0a68e-8a8a-4435-83af-66d0b0c7db81 50845-0172 HUMAN OTC DRUG LiverActive Bryonia, Carduus marianus, Chelidonium majus, Hepar suis, Taraxacum officinale, SPRAY ORAL 20111229 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; PORK LIVER; SILYBUM MARIANUM SEED; TARAXACUM OFFICINALE 200; 200; 6; 1; 1 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0173_4c3f6b1b-a6bb-4b15-8061-6db7428932b3 50845-0173 HUMAN OTC DRUG HGH Plus IGF 1and IGF 2 Arnica montana, Deer antler velvet, Hepar bovinum, HGH, IGF-1, Pituitary bovinum, Thuja occidentalis SPRAY ORAL 20111222 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; BEEF LIVER; BOS TAURUS PITUITARY GLAND; CERVUS ELAPHUS VELVET; MECASERMIN; SOMATROPIN; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 5; 8; 6; 24; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0177_d0442676-312b-48cd-b679-ebe89b7bbf92 50845-0177 HUMAN OTC DRUG Bedwetting Belladonna, Cantharis, Causticum, Cina, Equisetum hyemale, Ingatia amara, Physalis alkekengi, Sepia, Uranium nitricum, Verbascum thapsus, LIQUID ORAL 20121115 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARTEMISIA CINA PRE-FLOWERING TOP; ATROPA BELLADONNA; CAUSTICUM; EQUISETUM HYEMALE; LYTTA VESICATORIA; PHYSALIS ALKEKENGI FRUIT; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; URANYL NITRATE HEXAHYDRATE; VERBASCUM THAPSUS 6; 200; 200; 3; 200; 3; 200; 200; 12; 3 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 50845-0180_665f2f1e-6dbd-4ba2-9871-712f1624afa0 50845-0180 HUMAN OTC DRUG ProBLEN HGH Plus IGF-1 IGF-2 Arnica montana, Deer antler velvet, Hepar bovinum, HGH, IGF-1, Pitritary bovinum, Thuja occidentalis, SPRAY ORAL 20120214 UNAPPROVED HOMEOPATHIC Liddell Labratories, Inc. ARNICA MONTANA; BEEF LIVER; BOS TAURUS PITUITARY GLAND; CERVUS ELAPHUS VELVET; MECASERMIN; SOMATROPIN; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 5; 8; 8; 24; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0181_0a6ad168-716d-44f6-a8e1-5035f5ada629 50845-0181 HUMAN OTC DRUG Laxative Aloe socotrina, Alumina, Boldo, Bryonia, Graphittes, Iris versicolor, Lactobacillus acidophilus, Lycopodium clavatum, Nux vomica, Pyrogenium, Rhamnus purshiana, SPRAY ORAL 20120417 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; FRANGULA PURSHIANA BARK; GRAPHITE; IRIS VERSICOLOR ROOT; LACTOBACILLUS ACIDOPHILUS; LYCOPODIUM CLAVATUM SPORE; PEUMUS BOLDUS LEAF; RANCID BEEF; STRYCHNOS NUX-VOMICA SEED 3; 30; 6; 3; 12; 30; 14; 30; 1; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50845-0183_addbba5d-9f06-4520-a909-b46c35a36b10 50845-0183 HUMAN OTC DRUG Injuries Anthracinum, Arnica montana, Bellis perennis, Calendula officinalis, Echinacea, Hamamelis virginiana, Hypericum perforatum, Pyrogenium, SPRAY ORAL 20120418 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; RANCID BEEF 3; 30; 3; 3; 3; 3; 3; 200 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 50845-0186_0abb6e83-9a9b-4b9a-b123-084cc9e92578 50845-0186 HUMAN PRESCRIPTION DRUG Vaccines Arnica Montana, Mercurius Corrosivus, Sulphur Iodatum, Thuja Occidentalis, Urtica Urens, LIQUID ORAL 20131230 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; MERCURIC CHLORIDE; SULFUR IODIDE; THUJA OCCIDENTALIS LEAF; URTICA URENS 3; 200; 200; 200; 3 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 50845-0187_751c9b69-4957-43e0-98e7-49c37db91272 50845-0187 HUMAN OTC DRUG Vital Brain Energy Arnica Montana, Brain Suis, Carduus Marianus, Cinchona Officinalis, Ginkgo Biloba, Lecithin, Millefolium, Phosphoricum Acidum LIQUID ORAL 20131025 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACHILLEA MILLEFOLIUM; ARNICA MONTANA; CINCHONA OFFICINALIS BARK; EGG PHOSPHOLIPIDS; GINKGO; MILK THISTLE; PHOSPHORIC ACID; PORK BRAIN 3; 3; 6; 12; 6; 3; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50845-0188_c8460ccd-aa8a-4067-9f1f-d1c5924bce99 50845-0188 HUMAN OTC DRUG Colic Carbo vegetabilis, Cinchona officinalis, Colocynthis, Cuprum metallicum, Magnesia phosphorica, Ranunculus bulbosus, LIQUID ORAL 20121126 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACTIVATED CHARCOAL; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RANUNCULUS BULBOSUS 9; 6; 30; 30; 12; 6 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 50845-0189_0e849eb6-4abf-4442-8147-7371db565770 50845-0189 HUMAN OTC DRUG Antacid Anacardium orientale, Argentum nitricum, Arsenicum album, Bismuthum metallicum, Condurango, Geranium maculatum, Nux vomica, Pyrogenium, Robinia pseudoacacia, Sulphuricum acidum, SPRAY ORAL 20121115 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARSENIC TRIOXIDE; BISMUTH; GERANIUM MACULATUM ROOT; MARSDENIA CONDURANGO BARK; RANCID BEEF; ROBINIA PSEUDOACACIA BARK; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; SULFURIC ACID 200; 30; 3; 200; 30; 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0197_b0788dff-b7e0-4662-bed3-4eb0e1f429ad 50845-0197 HUMAN OTC DRUG Vital Male Sexual Energy Arnica montana, Caladium seguinum, Carduus marianus, Damiana, Galium aparine, Glandula suprarenalis suis, Hepar suis, Korean ginseng, Lactuca virosa, LIQUID ORAL 20140507 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; ASIAN GINSENG; DIEFFENBACHIA SEGUINE; GALIUM APARINE; LACTUCA VIROSA; MILK THISTLE; NUPHAR LUTEUM ROOT; PHOSPHORIC ACID; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; PORK LIVER; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA TESTICLE; SUS SCROFA THYMUS; TESTOSTERONE; THUJA OCCIDENTALIS LEAFY TWIG; TURNERA DIFFUSA LEAFY TWIG 3; 1; 6; 3; 3; 3; 2; 200; 1; 1; 6; 12; 12; 6; 6; 30; 200; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 50845-0200_ed747c0c-2033-4927-b13a-63dd6801fbe2 50845-0200 HUMAN OTC DRUG Candida Yeast Baptisia tinctoria, Borax, Candida albicans, Candida parapsilosis, Echinacea (angustifolia), Kreosotum, Mercurius cyantus, Mercurius sulphuratus ruber, SPRAY ORAL 20140221 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BAPTISIA TINCTORIA; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA ANGUSTIFOLIA; MERCURIC CYANIDE; MERCURIC SULFIDE; NITRIC ACID; RANCID BEEF; SODIUM BORATE; SULFURIC ACID; THUJA OCCIDENTALIS LEAF; WOOD CREOSOTE 3; 12; 8; 3; 30; 30; 30; 200; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50845-0202_1908b9f6-d2ca-4d92-9443-5f5cdccb9f0d 50845-0202 HUMAN OTC DRUG Pregnancy Balance Berber vulg, Carduus mar, Chelidonium maj, Podoph pelt, Serum anguillae, Symphoricarpus, Zingiber LIQUID ORAL 20140307 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANGUILLA ROSTRATA BLOOD SERUM; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; GINGER; MILK THISTLE; PODOPHYLLUM; SYMPHORICARPOS ALBUS FRUIT 30; 6; 6; 6; 3; 6; 200 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0203_1092cc4a-856d-46cf-860b-48b43ce21293 50845-0203 HUMAN OTC DRUG Daily Balance Arsenicum alb, Carbo an, Carduus mar, Kali iod, Lapis, Radium brom, Thuja oc LIQUID ORAL 20140307 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc ARSENIC TRIOXIDE; CALCIUM HEXAFLUOROSILICATE; CARBO ANIMALIS; MILK THISTLE; POTASSIUM IODIDE; RADIUM BROMIDE; THUJA OCCIDENTALIS LEAFY TWIG 200; 200; 200; 1; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50845-0204_fd5dd5ad-0103-4fb0-a732-3a4588af0cc1 50845-0204 HUMAN OTC DRUG Diabetes Type II Aesculus hippocastanum, Arnica montana, Arsenicum album, Hamamelis virginiana, Helonias dioica, Hepar suis, Iris versicolor, Pancreas suis, SPRAY ORAL 20140429 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; ARSENIC ACID; CHAMAELIRIUM LUTEUM ROOT; CLAVICEPS PURPUREA SCLEROTIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; IRIS VERSICOLOR ROOT; PHOSPHORIC ACID; PORK LIVER; ROSMARINUS OFFICINALIS FLOWERING TOP; SUS SCROFA PANCREAS; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 3; 200; 3; 30; 3; 1; 200; 200; 6; 3; 6; 3; 30 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 50845-0205_6a7f8cf0-d53a-48d9-a95e-11a0e9fb7cd9 50845-0205 HUMAN PRESCRIPTION DRUG Allergy Allium cepa, Apis mellifica, Aralia racemosa, Arundo mauritanica, Baptisia tinctoria, Echinacea (angustifolia), Euphrasia officinalis, Gelsemium sempervirens, SPRAY ORAL 20140314 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; ARALIA RACEMOSA ROOT; ARUNDO PLINIANA ROOT; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; ONION; SANGUINARIA CANADENSIS ROOT; SCHOENOCAULON OFFICINALE SEED; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 3; 6; 30; 3; 4; 6; 200; 12; 6; 6; 200; 6; 200; 3 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 50845-0206_6fb384bf-3c38-42da-90ea-625075136ff8 50845-0206 HUMAN OTC DRUG Ear Discomfort Aconitum napellus, Anthracinum, Arnica montana, Baptisia tintoria, Capsicum annuum, Chamomilla, Chenopodium anthelminticum, LIQUID ORAL 20140509 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; CAPSICUM; DYSPHANIA AMBROSIOIDES; EUPHORBIA RESINIFERA RESIN; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; MERCURIC CHLORIDE; PLANTAGO MAJOR; PULSATILLA VULGARIS; VERBASCUM THAPSUS 200; 200; 200; 3; 6; 6; 4; 200; 10; 3; 200; 3; 30; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0207_21116658-ca97-480a-a439-665f182b8d88 50845-0207 HUMAN OTC DRUG Cough plus Bronchial not applicable SPRAY ORAL 20140717 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANTIMONY POTASSIUM TARTRATE; ARISAEMA TRIPHYLLUM ROOT; ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; LOBARIA PULMONARIA; MERCURIC CHLORIDE; POTASSIUM BROMIDE; SULFUR IODIDE; SUS SCROFA LUNG; URTICA URENS 200; 30; 200; 200; 3; 200; 30; 3; 200; 200; 200; 6; 200; 6; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 50845-0208_c24c2709-7130-4858-890a-3f0d276a9b5e 50845-0208 HUMAN OTC DRUG Arthritis Aconitum napellus, Apis mellifica, Arnica montana, Berberis vulgaris, Bryonia (alba), Calcarea fluorica, Cartilago suis, Cimicifuga racemosa, Colchicum autumnale, SPRAY ORAL 20140527 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; COLCHICUM AUTUMNALE BULB; HYPERICUM PERFORATUM; MERCURIC CHLORIDE; RHODODENDRON AUREUM LEAF; SOLANUM DULCAMARA TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA CARTILAGE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 200; 200; 3; 30; 6; 200; 12; 200; 200; 200; 3; 200; 30; 8; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 50845-0209_5341ef36-eb0c-4871-9964-33a6c95bfa02 50845-0209 HUMAN OTC DRUG Sinus Congestion Headache NOT APPLICABLE SPRAY ORAL 20140613 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIIODIDE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA HIRTA FLOWERING TOP; GOLDENSEAL; LACHESIS MUTA VENOM; MERCURIC IODIDE; POTASSIUM DICHROMATE; RANCID BEEF; SILICON DIOXIDE; TEUCRIUM MARUM; WOOD CREOSOTE 6; 200; 30; 3; 30; 3; 3; 3; 30; 200; 10; 30; 200; 30; 3; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 50845-0211_a596db16-7571-480b-a09a-6a22603e08c2 50845-0211 HUMAN OTC DRUG Ear Discomfort Aconitum Napellus, Anthracinum, Arnica Montana, Baptisa Tinctoria, Capsicum Annuum, Chamomilla, Chenopodium Anthelminticum, LIQUID ORAL 20140708 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; CAPSICUM; DYSPHANIA AMBROSIOIDES; EUPHORBIA RESINIFERA RESIN; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; MERCURIC CHLORIDE; PLANTAGO MAJOR; PULSATILLA VULGARIS; VERBASCUM THAPSUS 200; 200; 200; 3; 6; 6; 4; 200; 8; 3; 200; 3; 30; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 50845-0212_1ab19500-9da6-46ec-a272-ff6952746557 50845-0212 HUMAN OTC DRUG Canker plus Cold Sore Relief not applicable SPRAY ORAL 20140908 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CAPSICUM; ECHINACEA ANGUSTIFOLIA; MERCURIC CHLORIDE; NITRIC ACID; RANCID BEEF; SODIUM BORATE; SOLANUM DULCAMARA TOP; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 3; 200; 3; 6; 3; 200; 200; 200; 200; 30; 200; 200; 200 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 50845-0213_d047a493-d52b-4155-a07e-012e43bcf5c1 50845-0213 HUMAN OTC DRUG Vital HGH Immune Booster NOT APPLICABLE SPRAY ORAL 20140918 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; MERCURIC CHLORIDE; MERCURIC SULFIDE; MILK THISTLE; NITRIC ACID; PORK LIVER; SODIUM BORATE; SOMATROPIN; SULFUR IODIDE; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THUJA OCCIDENTALIS LEAFY TWIG 200; 3; 3; 200; 30; 3; 30; 6; 30; 30; 200; 30; 6; 200 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 50859-100_5dc4d6ba-525d-412b-9bc9-8bd17595b3bb 50859-100 HUMAN OTC DRUG Ili Hand Sanitizer Instant Alcohol GEL TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part333E Strong Brands, Inc. ALCOHOL 63 mL/100mL 50865-025_f52dbdae-8fe2-4320-bd20-31ae3176c411 50865-025 HUMAN OTC DRUG Soft and Silky Antiseptic Antiseptic Lotion Soap SOLUTION TOPICAL 20131104 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. CHLOROXYLENOL 3.82 g/100mL 50865-050_01de5d07-ab55-481e-a23b-c224f48d3bff 50865-050 HUMAN OTC DRUG Soft and Silky/Health Guard Antibacterial Hand Antibacterial Hand Soap LIQUID TOPICAL 20130920 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. TRICLOSAN 11.7 g/100mL 50865-056_e5cfeb03-7d4a-41fa-9fda-b3ee64d78994 50865-056 HUMAN OTC DRUG Santi-Gel Instant Hand Sanitizer Santi-Gel Instant Hand Sanitizer SOLUTION TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. ALCOHOL 62.5 mL/100mL 50865-060_dac6322d-29a0-4794-ae58-f715a99c8beb 50865-060 HUMAN OTC DRUG Golden Medicated Medicated Lotion Soap SOLUTION TOPICAL 20140311 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. CHLOROXYLENOL .3 g/100mL 50865-076_8b85e5f9-57bb-4fb5-8d1f-42e79c31a55b 50865-076 HUMAN OTC DRUG 3 in 1 Antibacterial Hair and Body Wash 3 in 1 Antibacterial Hair and Body Wash SOLUTION TOPICAL 20131106 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. TRICLOSAN 11.7 g/100mL 50865-640_42c06641-a461-41f4-b189-8024cff0fcac 50865-640 HUMAN OTC DRUG eZFoam Foaming Antibacterial Moisture Wash Foaming Antibacterial Handwash SOLUTION TOPICAL 20140106 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc TRICLOSAN 18.9 g/100mL 50865-650_07b50de3-3759-4b15-92a1-a9c39caaf838 50865-650 HUMAN OTC DRUG Antibacterial Hand Cleaner with Aloe and Vitamin E Antibacterial Hand Soap with Aloe and Vitamin E SOLUTION TOPICAL 20130711 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. TRICLOSAN .3 g/100mL 50865-682_7dedfabe-2d9f-43bc-98c0-3f3aad855a23 50865-682 HUMAN OTC DRUG Foaming Instant Hand Sanitizer with Aloe and Vitamin E Foaming Instant Hand Sanitizer with Aloe and Vitamin E SOLUTION TOPICAL 20130517 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. BENZETHONIUM CHLORIDE 7.56 g/100mL 50865-688_20ad7115-6fbe-4639-9b52-b8a1c985ec0c 50865-688 HUMAN OTC DRUG ezFoam Foaming Alcohol Hand Sanitizer Foaming Hand Sanitizer SOLUTION TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. ALCOHOL 62 mL/100mL 50865-689_6b1dd498-17a9-4ea1-8f3d-b0f2a38144fe 50865-689 HUMAN OTC DRUG eZ Foam Foaming Antibacterial Hand Foaming Antibacterial Hand Soap with Aloe and Vitamin E SOLUTION TOPICAL 20130923 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. TRICLOSAN 18.9 g/100mL 50876-111_e52c45c0-5dea-4d96-91c6-ec981065ce13 50876-111 HUMAN OTC DRUG Cutiecaine Topical Lidocaine (4% w/w) CREAM TOPICAL 20100531 OTC MONOGRAPH NOT FINAL part348 Innovatech Inc LIDOCAINE HYDROCHLORIDE 40 mg/g 50876-182_e7d4de92-2088-42c9-885f-e9845fa16c1d 50876-182 HUMAN OTC DRUG Cutiecaine Topical Lidocaine (4% w/w) CREAM TOPICAL 20100831 OTC MONOGRAPH NOT FINAL part348 Innovatech Inc BENZOCAINE; TETRACAINE 180; 20 mg/g; mg/g 50881-005_dbdf04e1-638f-4984-ad67-31e99e3713f1 50881-005 HUMAN PRESCRIPTION DRUG JAKAFI ruxolitinib TABLET ORAL 20111116 NDA NDA202192 Incyte Corporation RUXOLITINIB 5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 50881-010_dbdf04e1-638f-4984-ad67-31e99e3713f1 50881-010 HUMAN PRESCRIPTION DRUG JAKAFI ruxolitinib TABLET ORAL 20111116 NDA NDA202192 Incyte Corporation RUXOLITINIB 10 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 50881-015_dbdf04e1-638f-4984-ad67-31e99e3713f1 50881-015 HUMAN PRESCRIPTION DRUG JAKAFI ruxolitinib TABLET ORAL 20111116 NDA NDA202192 Incyte Corporation RUXOLITINIB 15 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 50881-020_dbdf04e1-638f-4984-ad67-31e99e3713f1 50881-020 HUMAN PRESCRIPTION DRUG JAKAFI ruxolitinib TABLET ORAL 20111116 NDA NDA202192 Incyte Corporation RUXOLITINIB 20 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 50881-025_dbdf04e1-638f-4984-ad67-31e99e3713f1 50881-025 HUMAN PRESCRIPTION DRUG JAKAFI ruxolitinib TABLET ORAL 20111116 NDA NDA202192 Incyte Corporation RUXOLITINIB 25 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 50914-7720_4ae21854-e93b-4550-b544-1e0a093d0e47 50914-7720 HUMAN PRESCRIPTION DRUG Volumex Iodinated I-131 Albumin INJECTION, SOLUTION INTRAVENOUS 19930801 NDA NDA017837 Iso-Tex Diagnostics, Inc. IODINATED I-131 SERUM ALBUMIN .025 mCi/mL Radiopharmaceutical Activity [MoA] 50914-7729_e23f5f6f-c998-4735-a2cb-00364d83aff5 50914-7729 HUMAN PRESCRIPTION DRUG Glofil-125 Sodium Iothalamate I-125 injection INJECTION, SOLUTION INTRAVENOUS 19830501 NDA NDA017279 Iso-Tex Diagnostics, Inc. IOTHALAMATE SODIUM I-125 .275 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 50914-7731_78b13378-c056-4465-831e-fa8cb2e43332 50914-7731 HUMAN PRESCRIPTION DRUG Megatope Iodinated I-131 Albumin INJECTION, SOLUTION INTRAVENOUS 19900601 NDA NDA017837 Iso-Tex Diagnostics, Inc. IODINATED I-131 SERUM ALBUMIN 1 mCi/mL Radiopharmaceutical Activity [MoA] 50914-7732_60803567-6a3e-4d0f-b019-30c8fa8dd71e 50914-7732 HUMAN PRESCRIPTION DRUG Jeanatope Iodinated I-125 Albumin INJECTION, SOLUTION INTRAVENOUS 19900601 NDA NDA017836 Iso-Tex Diagnostics, Inc. IODINATED I-125 SERUM ALBUMIN .01 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 50928-200_f909739e-721b-4554-a94c-b077ddf59571 50928-200 HUMAN OTC DRUG DooBony Mosrepel GLYCERIN LOTION TOPICAL 20100515 OTC MONOGRAPH FINAL part347 DOOBON INC GLYCERIN 2 mL/40mL 50930-099_b9c6792d-9065-4297-a01e-b910534de448 50930-099 HUMAN OTC DRUG ORAGESIC Oral Pain Reliever BENZYL ALCOHOL, MENTHOL SOLUTION ORAL 20130102 OTC MONOGRAPH FINAL part356 Parnell Pharmaceuticals Inc BENZYL ALCOHOL; MENTHOL 10; .4 mg/mL; mg/mL 50942-001_55fcce5a-74cd-4987-8a1f-05dafead0fc5 50942-001 HUMAN OTC DRUG XtraCare Antifungal Foot Tolnaftate SPRAY TOPICAL 20140211 OTC MONOGRAPH FINAL part333C Taizhou Ludao Cosmetics Co., Ltd. TOLNAFTATE 1 g/100g 50942-002_92024057-4f9f-44d7-aa2a-8bd250278590 50942-002 HUMAN OTC DRUG Equate Liquid Foot Tolnaftate SPRAY TOPICAL 20140701 OTC MONOGRAPH FINAL part333C Taizhou Ludao Cosmetics Co., Ltd. TOLNAFTATE 1 g/150g 50942-003_cc3271d7-883d-4a8b-9881-bdc27dafac37 50942-003 HUMAN OTC DRUG Athletes Foot Tolnaftate SPRAY TOPICAL 20141104 OTC MONOGRAPH FINAL part333C Taizhou Ludao Cosmetics Co., Ltd. TOLNAFTATE 1 g/100g 50943-001_3b65d02e-38b1-4f67-8a30-fb7aa42d1ee2 50943-001 HUMAN OTC DRUG Top Medicated CAMPHOR (NATURAL), MENTHOL,METHYL SALICYLATE OIL TOPICAL 20120524 OTC MONOGRAPH FINAL part348 A&A Medical Supplies CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 10; 16; 50 mL/100mL; mL/100mL; mL/100mL 50945-001_be9da7a0-9893-4844-a2c1-9d2e0bb4e036 50945-001 HUMAN OTC DRUG All Day Freshness Antibacterial Body Wash with Moisturizer Triclosan SOLUTION TOPICAL 20100815 OTC MONOGRAPH NOT FINAL part333E Diversapack of Monroe, LLC TRICLOSAN .15 g/100g 50945-002_be9da7a0-9893-4844-a2c1-9d2e0bb4e036 50945-002 HUMAN OTC DRUG Gold Antibacterial Hand Soap with Moisturizer Triclosan SOLUTION TOPICAL 20100815 OTC MONOGRAPH NOT FINAL part333E Diversapack of Monroe, LLC TRICLOSAN .15 g/100g 50950-001_797f6d37-d5f8-4915-8a7c-a700961acd4d 50950-001 HUMAN OTC DRUG Iman Time Control All Day Moisture Complex SPF 15 OCTINOXATE CREAM TOPICAL 20100810 OTC MONOGRAPH NOT FINAL part352 Sheencolor Biotech Co., Ltd. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 50950-002_119a0977-e6ea-4291-9035-3fa1c0c01997 50950-002 HUMAN OTC DRUG Iman Time Control Oil Free Moisture Complex SPF 15 OCTINOXATE CREAM TOPICAL 20100910 OTC MONOGRAPH NOT FINAL part352 Sheencolor Biotech Co., Ltd. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 50952-001_cadd20c2-a235-431a-b13b-13fbc102e6cf 50952-001 HUMAN OTC DRUG Coolbottoms Diaper Rash Dimethicone CREAM TOPICAL 20100425 OTC MONOGRAPH FINAL part347 pH R&D LLC DIMETHICONE .57 g/57g 50952-002_84104452-0a4d-47f2-a65d-c9c3fd85f9a8 50952-002 HUMAN OTC DRUG NeutrapHor Skin Protectant Dimethicone CREAM TOPICAL 20100425 OTC MONOGRAPH FINAL part347 pH R&D LLC DIMETHICONE .57 g/57g 50952-003_8a3ce41f-e6c0-472f-868b-243d08962ad7 50952-003 HUMAN OTC DRUG NeutrapHorus Rex Skin Protectant Dimethicone CREAM TOPICAL 20101222 OTC MONOGRAPH FINAL part347 pH R&D LLC DIMETHICONE .57 g/57g 50952-009_ffb4a90f-636c-4f00-9c17-4d95eb522718 50952-009 HUMAN OTC DRUG GoodStuff Skin Protectant Dimethicone CREAM TOPICAL 20130526 OTC MONOGRAPH FINAL part347 pH R&D LLC DIMETHICONE 10 mg/g 50963-809_b2873eab-78c7-422f-86bf-3f6c18428490 50963-809 HUMAN OTC DRUG Motion Medicine Camphor, Menthol CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part348 Motion Medicine Inc. CAMPHOR (SYNTHETIC); MENTHOL 4; 4 g/100g; g/100g 50964-010_a38de797-1191-4d34-9f28-1fed2ba36ada 50964-010 HUMAN OTC DRUG HAMSOA YUYU DIAPER WITCH HAZEL CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .07 g/70g 50964-020_90e5b4f2-817a-45ca-a081-ce9083dfd0ec 50964-020 HUMAN OTC DRUG HAMSOA YUYU PURE MILD WASH WITCH HAZEL SOLUTION TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .3 g/300mL 50964-030_039d7186-06ff-4b9e-99ab-ea0bf89371ef 50964-030 HUMAN OTC DRUG HAMSOA ATOBY MEDI BATH AND WITCH HAZEL SHAMPOO TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .25 g/250mL 50964-040_594b78f1-27ca-4564-a88f-b2c53cf45c4a 50964-040 HUMAN OTC DRUG HAMSOA ATOBY MEDI WITCH HAZEL LOTION TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .15 g/150mL 50964-050_82953f70-5889-41a5-a1fe-c30ee09ebe43 50964-050 HUMAN OTC DRUG HAMSOA ATOBY MEDI WITCH HAZEL CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .05 g/50g 50964-060_27b65d68-18d2-44d1-831c-133737698bd0 50964-060 HUMAN OTC DRUG HAMSOA YUYU DERMA119 BALM WITCH HAZEL CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .009 g/9g 50964-070_2503b092-cf8f-4b75-9012-dd6aaed33244 50964-070 HUMAN OTC DRUG HAMSOA YUYU DERMA119 WITCH HAZEL CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .08 g/80g 50964-080_46ca591c-a8ed-4cd3-a0ee-2a2908b28462 50964-080 HUMAN OTC DRUG HAMSOA DR ATOBY WITCH HAZEL CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .06 g/60g 50964-090_5e52f1dc-51d1-4164-b910-347118f89c4a 50964-090 HUMAN OTC DRUG HAMSOA YUYU DEEP MOISTURE WITCH HAZEL LOTION TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .3 g/300mL 50964-100_9b68cbbd-8289-4671-8a7b-de3b728596b8 50964-100 HUMAN OTC DRUG HAMSOA YUYU PURE MILD FOAMING WASH WITCH HAZEL SOLUTION TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .3 g/300mL 50964-110_b37a8f43-3393-47fe-a3b6-335126395986 50964-110 HUMAN OTC DRUG HAMSOA DR ATOBY MIST WITCH HAZEL SOLUTION TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .06 g/60mL 50964-120_22546177-2f7d-448d-a157-9b327aac067d 50964-120 HUMAN OTC DRUG HAMSOA DR ATOBY FOAMING WASH WITCH HAZEL SOLUTION TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .2 g/200mL 50965-001_af2ff865-9d93-431f-af16-3cb4339d2503 50965-001 HUMAN OTC DRUG stop hair Citric Acid Monohydrate SPRAY TOPICAL 20120701 UNAPPROVED DRUG OTHER STOP HAIR PTY LTD CITRIC ACID MONOHYDRATE 7 mg/mL 50965-123_71a538d9-d0af-4ddf-8bee-5673cf25371a 50965-123 HUMAN OTC DRUG stop hair Citric Acid Monohydrate SPRAY TOPICAL 20120901 UNAPPROVED DRUG OTHER STOP HAIR PTY LTD CITRIC ACID MONOHYDRATE .7 mg/100mL 50967-126_3002c02d-94f5-42aa-ab3a-38fadd6fc777 50967-126 HUMAN PRESCRIPTION DRUG IROSPAN 24/6 IRON, FOLIC ACID, VITAMIN/MINERAL SUPPLEMENT KIT 20110415 UNAPPROVED DRUG OTHER WOMENS CHOICE PHARMACEUTICALS LLC 50967-219_63d82922-1e02-47f5-a64e-e97e2e1ba4ad 50967-219 HUMAN PRESCRIPTION DRUG NESTABS Prenatal Multi-vitamin/Mineral Supplement Multi-vitamin/Mineral Supplement with Sodium Ascorbate, Cholecalciferol, di-alpha-Tocopheryl Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine HCL, Folic Acid, Cyanocobalamin, Calcium TABLET, FILM COATED ORAL 20110201 UNAPPROVED DRUG OTHER WOMENS CHOICE PHARMACEUTICALS LLC .ALPHA.-TOCOPHEROL ACETATE, D-; CALCIUM CARBONATE; CALCIUM FORMATE; CHOLECALCIFEROL; CHOLINE BITARTRATE; CYANOCOBALAMIN; FERROUS BISGLYCINATE; FOLIC ACID; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC OXIDE 30; 45; 155; 450; 55; 10; 32; 1; 20; 100; 50; 3; 120; 3; 10 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 50967-309_641267b2-e086-450c-abeb-264755c8bc2b 50967-309 HUMAN PRESCRIPTION DRUG NESTABS ABC Prenatal Multi-vitamin/Mineral Supplement with DHA/EPA Sodium Ascorbate, Cholecalciferol, di-alpha-Tocopheryl Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine HCL, Folic Acid, Cyanocobalamin, Calcium Formate, Calcium Carbonate, Ferrous (II) bis-Glycinate Chelate, Potassium Iodide, Zinc Oxide, Choline Bitartrate, with doconexent and icosapent KIT 20131001 UNAPPROVED DRUG OTHER WOMENS CHOICE PHARMACEUTICALS LLC 50967-317_bb5988d9-7098-4af8-8f04-2c55137a57ec 50967-317 HUMAN PRESCRIPTION DRUG NESTABS DHA Prenatal Multi-vitamin/Mineral Supplement with DHA/EPA Sodium Ascorbate, Cholecalciferol, di-alpha-Tocopheryl Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine HCL, Folic Acid, Cyanocobalamin, Calcium Formate, Calcium Carbonate, Ferrous ( KIT 20110201 UNAPPROVED DRUG OTHER WOMENS CHOICE PHARMACEUTICALS LLC 50967-357_9eb11712-e770-42a2-a3af-1a98901c234d 50967-357 HUMAN PRESCRIPTION DRUG PROCORT 1.85% hydrocortisone acetate - 1.15% pramoxine hci cream CREAM TOPICAL 20110630 UNAPPROVED DRUG OTHER Womens Choice Pharmaceuticals LLC HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 18.5; 11.5 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 50967-620_2fda2720-5d64-40fb-a37b-b713e7137659 50967-620 HUMAN PRESCRIPTION DRUG Isometheptene Mucate, Caffeine, and Acetaminophen Isometheptene Mucate, Caffeine, and Acetaminophen TABLET ORAL 20111012 UNAPPROVED DRUG OTHER Womens Choice Pharmaceuticals, LLC ACETAMINOPHEN; CAFFEINE; ISOMETHEPTENE MUCATE 500; 20; 130 mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 50970-001_ac8d5688-c210-4410-8e27-5816216a8074 50970-001 HUMAN OTC DRUG e-HCG Fat Release System arginine, acetylcarnitine, l-, ornithine and human chorionic gonadotropin LIQUID ORAL 20100819 UNAPPROVED HOMEOPATHIC AnuMed International LLC ACETYLCARNITINE, L-; ARGININE; HUMAN CHORIONIC GONADOTROPIN; ORNITHINE 30; 30; 60; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 50970-002_6b613a6f-64cc-4cda-88c4-27e839cc5e43 50970-002 HUMAN OTC DRUG e-HGH hGH somatropin LIQUID ORAL 20110501 UNAPPROVED HOMEOPATHIC AnuMed International LLC SOMATROPIN 6 [hp_C]/200mL 50970-003_1049d373-8b88-49fa-a4ca-8461e8b24247 50970-003 HUMAN OTC DRUG IGF-1 Endurance Plus insulin-like growth factor-1 (IGF-1) LIQUID ORAL 20110501 UNAPPROVED HOMEOPATHIC AnuMed International LLC MECASERMIN 30 [hp_C]/30mL 50972-272_6f37c3b4-486a-4419-a6de-a35797e630fd 50972-272 HUMAN OTC DRUG Arthritis Relief Menthol CREAM TOPICAL 20120413 OTC MONOGRAPH NOT FINAL part348 NewMarket Health Products LLC MENTHOL 12.5 mg/g 50972-273_5df4496e-e101-4e1c-bee1-ad22930ac7bf 50972-273 HUMAN OTC DRUG Arthritis Relief Menthol CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 NewMarket Health Products LLC MENTHOL 12.5 mg/g 50972-278_ae40b06d-2f5f-4b47-a887-54fc40f8422b 50972-278 HUMAN OTC DRUG ArthriPain Relief Menthol CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part348 NDI Solutions LLC MENTHOL 12.5 mg/g 50972-736_0034d5d4-3de7-4dc5-be59-974c10940ca2 50972-736 HUMAN OTC DRUG Trienelle Skincare Daily Renewal Creme with Tocallure Restoration Complex Broad Spectrum SPF 15 Octinoxate 5%, Oxybezone 4.5%, Avobenzone 3% CREAM TOPICAL 20140929 OTC MONOGRAPH NOT FINAL part352 NewMarket Health Products LLC AVOBENZONE; OCTINOXATE; OXYBENZONE 3; 5; 4.5 mg/g; mg/g; mg/g 50972-766_8ad382e5-f124-4325-a5ab-d66cf3800239 50972-766 HUMAN OTC DRUG Soothanol X2 Capsaicin and Menthol SOLUTION/ DROPS TOPICAL 20140611 OTC MONOGRAPH NOT FINAL part348 NewMarket Health Products LLC CAPSAICIN; MENTHOL 2; 120 mg/g; mg/g 50973-1001_c6e34a76-e65a-406b-b4bd-e074b7a930fe 50973-1001 HUMAN OTC DRUG Okyongsoo NARDOSTACHYS CHINENSIS WHOLE LIQUID TOPICAL 20120618 UNAPPROVED DRUG OTHER Woori Health Promotion Town NARDOSTACHYS CHINENSIS WHOLE 1 mL/100mL 50973-2001_d9bd3c2e-be29-4489-a2c1-0ab01f98e5cd 50973-2001 HUMAN OTC DRUG Okyong pack NARDOSTACHYS CHINENSIS WHOLE PASTE TOPICAL 20120618 UNAPPROVED DRUG OTHER Woori Health Promotion Town NARDOSTACHYS CHINENSIS WHOLE 1 mL/100mL 50975-001_53930432-8f66-4865-8a8f-59d997cfaa01 50975-001 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Fox Welding Supply Inc OXYGEN 990 mL/L 50975-011_e9b51081-bef8-4327-b9db-dbad9ef7c9d4 50975-011 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205865 Fox Welding Supply Inc OXYGEN 990 mL/L 50980-056_fa27c641-6206-4e4e-893e-e9ce56515820 50980-056 HUMAN OTC DRUG Ben E.Keith Hand Cleaner Ethyl Alcohol GEL TOPICAL 20090102 OTC MONOGRAPH NOT FINAL part333 Ben E. Keith ETHANOL 62 mL/100mL 50980-078_3e1f0531-1aa4-469f-a7dd-44d5126eb93d 50980-078 HUMAN OTC DRUG Ben E. Keith Antibacterial Hand Cleaner Triclosan LIQUID TOPICAL 20100618 OTC MONOGRAPH NOT FINAL part333 Ben E. Keith Foods TRICLOSAN .5 mL/100mL 50980-682_adcad4ea-5459-45b4-b5e2-453c28c64064 50980-682 HUMAN OTC DRUG Ben E. Keith Foam Sanitizer Benzethonium Chloride LIQUID TOPICAL 20100102 OTC MONOGRAPH NOT FINAL part333A Ben E. Keith Foods BENZETHONIUM CHLORIDE .2 mL/100mL 50980-689_442afcd9-a288-48d8-8671-9f0bc880cea8 50980-689 HUMAN OTC DRUG Ben E. Keith Foaming Antibacterial Hand Cleaner Triclosan LIQUID TOPICAL 20100102 OTC MONOGRAPH NOT FINAL part333A Ben E. Keith Foods TRICLOSAN .5 mL/100mL 50988-150_a6e2b980-65cb-4499-8c89-3245a70b1810 50988-150 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100601 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-170_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-170 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-171_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-171 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-172_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-172 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-173_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-173 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-174_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-174 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-175_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-175 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-176_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-176 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-177_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-177 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-178_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-178 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-179_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-179 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20110515 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-180_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-180 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20110515 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-181_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-181 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-182_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-182 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-183_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-183 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-184_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-184 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-185_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-185 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-186_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-186 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL 50988-190_2220b62f-fed4-4304-9747-805f485be4ce 50988-190 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL 50988-191_2220b62f-fed4-4304-9747-805f485be4ce 50988-191 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL 50988-192_2220b62f-fed4-4304-9747-805f485be4ce 50988-192 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL 50988-193_2220b62f-fed4-4304-9747-805f485be4ce 50988-193 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL 50988-194_2220b62f-fed4-4304-9747-805f485be4ce 50988-194 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL 50988-195_2220b62f-fed4-4304-9747-805f485be4ce 50988-195 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL 50988-196_2220b62f-fed4-4304-9747-805f485be4ce 50988-196 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL 50988-197_2220b62f-fed4-4304-9747-805f485be4ce 50988-197 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20101201 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL 50988-198_2220b62f-fed4-4304-9747-805f485be4ce 50988-198 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20101201 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL 50988-210_c089e2c4-d768-432a-8fdc-85d37a7d316e 50988-210 HUMAN OTC DRUG Antibacterial Hand Soap Triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .994 mL/331.22mL 50988-211_c089e2c4-d768-432a-8fdc-85d37a7d316e 50988-211 HUMAN OTC DRUG Antibacterial Hand Soap Triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .994 mL/331.22mL 50988-212_c089e2c4-d768-432a-8fdc-85d37a7d316e 50988-212 HUMAN OTC DRUG Antibacterial Hand Soap Triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .994 mL/331.22mL 50988-213_c089e2c4-d768-432a-8fdc-85d37a7d316e 50988-213 HUMAN OTC DRUG Antibacterial Hand Soap Triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .994 mL/331.22mL 50988-214_c089e2c4-d768-432a-8fdc-85d37a7d316e 50988-214 HUMAN OTC DRUG Antibacterial Hand Soap Triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .994 mL/331.22mL 50988-215_c089e2c4-d768-432a-8fdc-85d37a7d316e 50988-215 HUMAN OTC DRUG Antibacterial Hand Soap Triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .994 mL/331.22mL 50988-216_c089e2c4-d768-432a-8fdc-85d37a7d316e 50988-216 HUMAN OTC DRUG Antibacterial Hand Soap Triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .994 mL/331.22mL 50988-230_519f1a8e-a262-4e40-978e-b5553fb3666c 50988-230 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 50988-231_519f1a8e-a262-4e40-978e-b5553fb3666c 50988-231 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 50988-232_519f1a8e-a262-4e40-978e-b5553fb3666c 50988-232 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 50988-233_519f1a8e-a262-4e40-978e-b5553fb3666c 50988-233 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 50988-234_519f1a8e-a262-4e40-978e-b5553fb3666c 50988-234 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 50988-250_b168e9ae-501e-4a49-849d-298f75f12f82 50988-250 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 50988-251_b168e9ae-501e-4a49-849d-298f75f12f82 50988-251 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 50988-252_b168e9ae-501e-4a49-849d-298f75f12f82 50988-252 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 50988-253_b168e9ae-501e-4a49-849d-298f75f12f82 50988-253 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 50988-254_b168e9ae-501e-4a49-849d-298f75f12f82 50988-254 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 50988-270_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-270 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL 50988-271_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-271 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL 50988-272_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-272 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL 50988-273_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-273 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL 50988-274_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-274 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL 50988-275_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-275 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL 50988-276_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-276 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL 50988-277_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-277 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL 50988-278_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-278 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL 50988-280_f62761bb-26fb-41b6-99e0-69f321a3d636 50988-280 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120320 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-281_f62761bb-26fb-41b6-99e0-69f321a3d636 50988-281 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120320 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-282_f62761bb-26fb-41b6-99e0-69f321a3d636 50988-282 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120320 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-283_f62761bb-26fb-41b6-99e0-69f321a3d636 50988-283 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120320 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-284_71f0dead-1b4e-4ce4-8f15-9969c129cec1 50988-284 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-285_71f0dead-1b4e-4ce4-8f15-9969c129cec1 50988-285 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-286_71f0dead-1b4e-4ce4-8f15-9969c129cec1 50988-286 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-287_71f0dead-1b4e-4ce4-8f15-9969c129cec1 50988-287 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-288_25b02f75-73d9-4590-b020-5fd488a05328 50988-288 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120621 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-289_25b02f75-73d9-4590-b020-5fd488a05328 50988-289 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120621 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-290_26c4a966-78fa-4069-9f4a-dedff5ab972e 50988-290 HUMAN OTC DRUG Antibacterial Foaming Hand Benzalkonium Chloride SOLUTION TOPICAL 20120125 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .325 mL/295.74mL 50988-291_26c4a966-78fa-4069-9f4a-dedff5ab972e 50988-291 HUMAN OTC DRUG Antibacterial Foaming Hand Benzalkonium Chloride SOLUTION TOPICAL 20120125 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .325 mL/295.74mL 50988-292_26c4a966-78fa-4069-9f4a-dedff5ab972e 50988-292 HUMAN OTC DRUG Antibacterial Foaming Hand Benzalkonium Chloride SOLUTION TOPICAL 20120125 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .325 mL/295.74mL 50988-293_26c4a966-78fa-4069-9f4a-dedff5ab972e 50988-293 HUMAN OTC DRUG Antibacterial Foaming Hand Benzalkonium Chloride SOLUTION TOPICAL 20120125 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .325 mL/295.74mL 50988-294_ce8fcd75-1c90-4c29-a1cb-2f81551c8bd3 50988-294 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Cleanser TRICLOSAN SOLUTION TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .3 mL/100mL 50988-295_ce8fcd75-1c90-4c29-a1cb-2f81551c8bd3 50988-295 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Cleanser TRICLOSAN SOLUTION TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .3 mL/100mL 50988-296_b6057e65-e3dd-4996-900b-33ad600ccfe8 50988-296 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN GEL TOPICAL 20120807 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN 3 mg/mL 50988-297_b6057e65-e3dd-4996-900b-33ad600ccfe8 50988-297 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN GEL TOPICAL 20120807 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN 3 mg/mL 50988-298_b6057e65-e3dd-4996-900b-33ad600ccfe8 50988-298 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN GEL TOPICAL 20120807 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN 3 mg/mL 50988-299_b6057e65-e3dd-4996-900b-33ad600ccfe8 50988-299 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN GEL TOPICAL 20120807 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN 3 mg/mL 50988-300_b6057e65-e3dd-4996-900b-33ad600ccfe8 50988-300 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN GEL TOPICAL 20120807 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN 3 mg/mL 50988-301_b6057e65-e3dd-4996-900b-33ad600ccfe8 50988-301 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN GEL TOPICAL 20120807 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN 3 mg/mL 50988-302_b6057e65-e3dd-4996-900b-33ad600ccfe8 50988-302 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN GEL TOPICAL 20120807 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN 3 mg/mL 50988-303_327d20bb-2f16-4b3d-8106-d877f47d53e3 50988-303 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Cleanser TRICLOSAN SOLUTION TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .3 mL/100mL 50988-304_327d20bb-2f16-4b3d-8106-d877f47d53e3 50988-304 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Cleanser TRICLOSAN SOLUTION TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .3 mL/100mL 50988-400_25b02f75-73d9-4590-b020-5fd488a05328 50988-400 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120621 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-401_25b02f75-73d9-4590-b020-5fd488a05328 50988-401 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120621 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-402_25b02f75-73d9-4590-b020-5fd488a05328 50988-402 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120621 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-405_d0004ee4-2da6-4750-bbd1-ca952444dcf7 50988-405 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-406_d0004ee4-2da6-4750-bbd1-ca952444dcf7 50988-406 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-407_d0004ee4-2da6-4750-bbd1-ca952444dcf7 50988-407 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL 50988-450_da428ddd-de07-4b5d-ab9b-1de508ba7957 50988-450 HUMAN OTC DRUG Shopko Antibacterial Deep Cleansing Hand Triclosan GEL TOPICAL 20120622 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .2 mL/100mL 50988-451_da428ddd-de07-4b5d-ab9b-1de508ba7957 50988-451 HUMAN OTC DRUG Shopko Antibacterial Deep Cleansing Hand Triclosan GEL TOPICAL 20120622 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .2 mL/100mL 50988-452_da428ddd-de07-4b5d-ab9b-1de508ba7957 50988-452 HUMAN OTC DRUG Shopko Antibacterial Deep Cleansing Hand Triclosan GEL TOPICAL 20120622 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .2 mL/100mL 50988-453_da428ddd-de07-4b5d-ab9b-1de508ba7957 50988-453 HUMAN OTC DRUG Shopko Antibacterial Deep Cleansing Hand Triclosan GEL TOPICAL 20120622 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .2 mL/100mL 50988-454_da428ddd-de07-4b5d-ab9b-1de508ba7957 50988-454 HUMAN OTC DRUG Shopko Antibacterial Deep Cleansing Hand Triclosan GEL TOPICAL 20120622 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .2 mL/100mL 50991-114_7111cf75-c4f5-4ba2-8ef8-e1ba034f14d3 50991-114 HUMAN OTC DRUG POLY-TUSSIN D Chlorcyclizine Hydrochloride, Codeine Phosphate, Pseudoephedrine Hydrochloride LIQUID ORAL 20120918 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals CHLORCYCLIZINE HYDROCHLORIDE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 9.375; 10; 30 mg/5mL; mg/5mL; mg/5mL CV 50991-119_6c01cfd5-c9cf-4a38-9a48-36ad72afd01c 50991-119 HUMAN OTC DRUG POLY-TUSSIN Chlorcyclizine Hydrochloride, Codeine Phosphate LIQUID ORAL 20120918 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals CHLORCYCLIZINE HYDROCHLORIDE; CODEINE PHOSPHATE 9.375; 10 mg/5mL; mg/5mL CV 50991-212_a5adcdb9-ad24-4455-ab29-d5514660a853 50991-212 HUMAN OTC DRUG Poly-Vent IR Guaifenesin and Pseudoephedrine HCl TABLET ORAL 20130611 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 380; 60 mg/1; mg/1 50991-214_7724ca13-e906-403a-a9a9-c6b565b7c9c8 50991-214 HUMAN OTC DRUG Poly-Vent DM Dextromethorphan HBr, Guaifenesin and Pseudoephedrine HCl TABLET ORAL 20130617 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 20; 380; 60 mg/1; mg/1; mg/1 50991-216_b6db7835-22bc-41fa-b61d-bf482c76a692 50991-216 HUMAN OTC DRUG Poly Hist Forte Doxylamine Succinate and Phenylephrine Hydrochloride TABLET ORAL 20131001 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 7.5; 10 mg/1; mg/1 50991-220_795dd040-2aef-47a6-9da3-7469f4e97950 50991-220 HUMAN OTC DRUG Poly-Hist DM Dextromethorphan Hydrobromide, Phenylephrine HCl and Thonzylamine HCl LIQUID ORAL 20130622 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; THONZYLAMINE HYDROCHLORIDE 10; 5; 25 mg/5mL; mg/5mL; mg/5mL 50991-222_77e16d21-a5b6-4699-bcf1-cf5ac5ebb67f 50991-222 HUMAN OTC DRUG Poly Hist PD Thonzylamine Hydrochloride and Chlophedianol Hydrochloride LIQUID ORAL 20130701 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. CHLOPHEDIANOL HYDROCHLORIDE; THONZYLAMINE HYDROCHLORIDE 6.25; 6.25 mg/mL; mg/mL 50991-312_10b89359-6bf5-4dbe-9552-edf7e69c4a36 50991-312 HUMAN PRESCRIPTION DRUG Cocet Plus acetaminophen and codeine phosphate TABLET ORAL 20100629 ANDA ANDA089363 Poly Pharmaceuticals ACETAMINOPHEN; CODEINE PHOSPHATE 650; 60 mg/1; mg/1 CIII 50991-320_c7720496-e9a6-4a60-ae62-413e258475b8 50991-320 HUMAN OTC DRUG POLY-TUSSIN DM Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Chlorpheniramine Maleate SYRUP ORAL 20051021 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 15; 5 mg/5mL; mg/5mL; mg/5mL 50991-323_232ff72a-20d9-4507-9d93-340d51ae60bf 50991-323 HUMAN OTC DRUG Foltrate Folic Acid and Cyanocobalamin TABLET, FILM COATED ORAL 20100826 UNAPPROVED DRUG OTHER Poly Pharmaceuticals, Inc. CYANOCOBALAMIN; FOLIC ACID 500; 1 ug/1; mg/1 50991-399_81f0d571-d0b5-4f79-b886-a487eab113e6 50991-399 HUMAN PRESCRIPTION DRUG Recede benzphetamine hydrochloride TABLET ORAL 20120201 ANDA ANDA090473 Poly Pharmaceuticals, Inc. BENZPHETAMINE HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 50991-405_0b40b3cb-4d80-4b14-863f-30ae972bceb1 50991-405 HUMAN PRESCRIPTION DRUG POLY HIST PD Pyrilamine Maleate, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride LIQUID ORAL 20040805 UNAPPROVED DRUG OTHER Poly Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE 2; 7.5; 12.5 mg/5mL; mg/5mL; mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 50991-510_df31d5c7-231f-48ce-b38c-8a5bc1d15cf8 50991-510 HUMAN OTC DRUG Duraflu ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl TABLET, FILM COATED ORAL 20110210 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 500; 20; 200; 60 mg/1; mg/1; mg/1; mg/1 50991-514_59c596f9-f9c7-48f8-8475-e0dfd03de1c2 50991-514 HUMAN PRESCRIPTION DRUG Alagesic LQ butalbital, acetaminophen and caffeine SYRUP ORAL 20100215 ANDA ANDA089175 Poly Pharmaceuticals, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/15mL; mg/15mL; mg/15mL Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 50991-521_8a262cac-35a4-4949-8cc0-efd9b9d311bc 50991-521 HUMAN PRESCRIPTION DRUG POLY HIST DHC Dihydrocodeine Bitartrate, Phenylephrine Hydrochloride, Pyrilamine Maleate LIQUID ORAL 20091112 UNAPPROVED DRUG OTHER Poly Pharmaceuticals, Inc. DIHYDROCODEINE BITARTRATE; PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE 7.5; 5; 7.5 mg/5mL; mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] CIII 50991-529_5c8c0310-14a9-4200-8a80-cabee2bb4ab5 50991-529 HUMAN PRESCRIPTION DRUG POLY-TUSSIN EX Dihydrocodeine Bitartrate, Phenylephrine Hydrochloride, and Guaifenesin SYRUP ORAL 20091116 UNAPPROVED DRUG OTHER Poly Pharmaceuticals, Inc. DIHYDROCODEINE BITARTRATE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 7.5; 50; 5 mg/5mL; mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] CIII 50991-578_27a7e831-d786-40ec-aa88-e53691061851 50991-578 HUMAN PRESCRIPTION DRUG IBUDONE hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20061106 ANDA ANDA077727 Poly Pharmaceuticals HYDROCODONE BITARTRATE; IBUPROFEN 5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 50991-579_27a7e831-d786-40ec-aa88-e53691061851 50991-579 HUMAN PRESCRIPTION DRUG IBUDONE hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20061106 ANDA ANDA077723 Poly Pharmaceuticals HYDROCODONE BITARTRATE; IBUPROFEN 10; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 50991-582_5c441a30-38ef-4e2d-9c11-b49d647e340a 50991-582 HUMAN OTC DRUG DECONEX Guaifenesin, Phenylephrine Hydrochloride CAPSULE ORAL 20120207 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 390; 10 mg/1; mg/1 50991-583_0b429b11-e8a8-4bbc-a7c3-1afcaff547d6 50991-583 HUMAN OTC DRUG DECONEX DM Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride CAPSULE ORAL 20120208 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 390; 10 mg/1; mg/1; mg/1 50991-597_63857ec2-106a-4e39-bdc2-b15a4a0d3ff1 50991-597 HUMAN OTC DRUG LORTUSS LQ Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID ORAL 20110222 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 6.25; 30 mg/5mL; mg/5mL 50991-598_1522ab60-416a-4d09-8552-833b321a92e6 50991-598 HUMAN OTC DRUG LORTUSS DM Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID ORAL 20110314 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 6.25 mg/5mL; mg/5mL 50991-607_d6135456-8e0d-48d2-8cad-db2ff4538947 50991-607 HUMAN OTC DRUG Alahist LQ Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride LIQUID ORAL 20071220 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 25; 7.5 mg/5mL; mg/5mL 50991-716_27c3d7bb-1df8-43cb-8344-fcafe4b734cb 50991-716 HUMAN OTC DRUG DECONEX IR Guaifenesin, Phenylephrine Hydrochloride TABLET ORAL 20120225 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 380; 10 mg/1; mg/1 50991-723_478b407f-5dfd-4f11-a576-d8c48bcf4eb9 50991-723 HUMAN OTC DRUG Poly-Tussin AC Brompheniramine Maleate, Codeine Phosphate, Phenylephrine Hydrochloride LIQUID ORAL 20140602 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10; 10 mg/5mL; mg/5mL; mg/5mL CV 50991-730_0f3c59a2-4844-4255-9398-9ee63a8a796c 50991-730 HUMAN OTC DRUG DECONEX DMX Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET ORAL 20120217 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 380; 10 mg/1; mg/1; mg/1 50991-781_582a7a13-fdb4-4e80-8387-a34b140627ef 50991-781 HUMAN PRESCRIPTION DRUG Poly Hist CB Carbetapentane Citrate, and Guaifenesin LIQUID ORAL 20091130 UNAPPROVED DRUG OTHER Poly Pharmaceuticals, Inc. CARBETAPENTANE CITRATE; GUAIFENESIN 20; 75 mg/5mL; mg/5mL 50991-782_40576235-38d4-440b-84a5-e7b31d9824b6 50991-782 HUMAN OTC DRUG ALA-HIST PE Phenylephrine Hydrochloride, Dexbrompheniramine Maleate TABLET ORAL 20110915 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals DEXBROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 2; 10 mg/1; mg/1 50991-783_43dc22bc-37a8-4220-950b-3c0677ffa794 50991-783 HUMAN OTC DRUG ALA-HIST IR Dexbrompheniramine Maleate TABLET ORAL 20110822 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. DEXBROMPHENIRAMINE MALEATE 2 mg/1 50991-814_30bd7389-43e7-4850-805b-cc5f3c1977b0 50991-814 HUMAN OTC DRUG ALAHIST DM Brompheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide LIQUID ORAL 20071227 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 15; 7.5 mg/5mL; mg/5mL; mg/5mL 50991-901_eb9b8199-a013-48fe-9dc7-2bd82c72a087 50991-901 HUMAN OTC DRUG ALA-HIST AC Codeine Phosphate, Phenylephrine Hydrochloride LIQUID ORAL 20071221 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE 10; 7.5 mg/5mL; mg/5mL CV 50996-001_8e0b24f8-0f26-4ef6-829f-e88a4797c716 50996-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20100602 UNAPPROVED MEDICAL GAS Smith's Drugs fo Forest City, Inc. dba Smith Drugs OXYGEN 99 L/100L 51004-0053_6d411f9f-9f58-4485-a156-75319af82d9f 51004-0053 HUMAN PRESCRIPTION DRUG Mepivacaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20130731 ANDA ANDA088387 Novocol Pharmaceutical of Canada, Inc. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 51004-0550_bf13c71d-bcf8-4d7e-a588-15c34b9830df 51004-0550 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088389 Novocol Pharmaceutical of Canada, Inc. EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .02; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 51004-1051_553c5066-3cba-4c73-a2db-9f18291c15ed 51004-1051 HUMAN PRESCRIPTION DRUG LIDOCAINE Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088390 Novocol Pharmaceutical of Canada, Inc. EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 51004-1095_ee2c519b-e285-4bde-81ed-f109f64088a7 51004-1095 HUMAN PRESCRIPTION DRUG Lignospan Standard Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111015 ANDA ANDA088390 Novocol Pharmaceutical of Canada, Inc. EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 51004-1096_423fe27a-90e8-45e3-82dd-bbbc726fae33 51004-1096 HUMAN PRESCRIPTION DRUG Lignospan Forte Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111015 ANDA ANDA088390 Novocol Pharmaceutical of Canada, Inc. EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .02; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 51004-1097_59fcd689-a6a3-4739-a982-6b41c249de7b 51004-1097 HUMAN PRESCRIPTION DRUG Scandonest L Mepivacaine Hydrochloride and Levonordefrin INJECTION, SOLUTION SUBCUTANEOUS 20130627 ANDA ANDA088388 Novocol Pharmaceutical of Canada, Inc LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE .05; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 51004-1098_9832a4f7-24d4-46f8-9099-1928c0e79b49 51004-1098 HUMAN PRESCRIPTION DRUG Scandonest Plain Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20130626 ANDA ANDA088387 Novocol Pharmaceutical of Canada, Inc. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 51004-2010_ba7ff05c-cdd8-4f17-a908-8e847ea35a75 51004-2010 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine Bitartrate Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088390 Novocol Pharmaceutical of Canada, Inc. EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 51004-2020_163ceaa4-f528-4a64-8515-3e98fe208856 51004-2020 HUMAN PRESCRIPTION DRUG Isocaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20100820 ANDA ANDA088387 Novocol Pharmaceutical of Canada, Inc. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 51009-001_77266f5a-205d-4fb0-ab47-53ddc9eaa2ac 51009-001 HUMAN OTC DRUG Anticavity Juicy mint Sodium Fluoride RINSE DENTAL 20100830 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .46277 mg/mL 51009-100_3452f64a-225d-428c-95d3-df5bd9c8d826 51009-100 HUMAN OTC DRUG Whole Care Cinnamon Clove Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g 51009-104_3452f64a-225d-428c-95d3-df5bd9c8d826 51009-104 HUMAN OTC DRUG Whole Care Peppermint Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g 51009-105_3452f64a-225d-428c-95d3-df5bd9c8d826 51009-105 HUMAN OTC DRUG Whole Care Spearmint Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g 51009-106_3452f64a-225d-428c-95d3-df5bd9c8d826 51009-106 HUMAN OTC DRUG Whole Care Wintermint Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g 51009-107_9302cac5-ef68-484a-b3ee-d120b4be4587 51009-107 HUMAN OTC DRUG Clean and Gentle Peppermint Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g 51009-111_435be901-9138-40ff-9010-86db6e6105da 51009-111 HUMAN OTC DRUG Cavity Protection Wintermint Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g 51009-116_873dc868-9a54-452c-ae24-e090e8464a05 51009-116 HUMAN OTC DRUG Cavity Protection Spearmint Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g 51009-119_6381cc75-dba7-4ace-a16b-2ebe41b0d880 51009-119 HUMAN OTC DRUG Whole Care Orange Mango Sodium fluoride PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g 51009-120_873dc868-9a54-452c-ae24-e090e8464a05 51009-120 HUMAN OTC DRUG Cavity Protection Peppermint with baking soda Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g 51009-127_14754960-8e32-4c3c-b41d-f5ed6fdc2c74 51009-127 HUMAN OTC DRUG Childrens Outrageous Orange Mango Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20100830 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g 51009-128_81c745f1-4123-4e7a-9808-864dc83aab26 51009-128 HUMAN OTC DRUG Childrens Silly Strawberry Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20100830 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g 51009-145_2b78fb8e-26c2-45b4-9a62-ba0eef379244 51009-145 HUMAN OTC DRUG Long-Lasting Wicked Fresh - Spearmint Ice Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20091130 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g 51009-145_380e2556-177d-4937-b2d1-7e3f8f819c80 51009-145 HUMAN OTC DRUG Long-Lasting Wicked Fresh - Spearmint Ice Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20110506 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g 51009-146_380e2556-177d-4937-b2d1-7e3f8f819c80 51009-146 HUMAN OTC DRUG Long-Lasting Wicked Fresh - Cool Peppermint Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20110506 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g 51009-146_9ec12240-a65a-4f5d-8059-f33e5b283adc 51009-146 HUMAN OTC DRUG Long-Lasting Wicked Fresh - Cool Peppermint Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20091130 OTC MONOGRAPH FINAL part335 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g 51009-148_2aae47ad-fe31-4232-b786-bf5cf28f5fe0 51009-148 HUMAN OTC DRUG Simply White clean mint Sodium fluoride PASTE, DENTIFRICE DENTAL 20110204 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .0024 g/g 51009-149_bd7d3ba3-496f-4a16-a3fb-619c37a922e4 51009-149 HUMAN OTC DRUG Simply White sweet mint Sodium fluoride PASTE, DENTIFRICE DENTAL 20100312 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .0024 g/g 51009-153_6381cc75-dba7-4ace-a16b-2ebe41b0d880 51009-153 HUMAN OTC DRUG Whole Care Spearmint Sodium fluoride PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g 51009-158_6381cc75-dba7-4ace-a16b-2ebe41b0d880 51009-158 HUMAN OTC DRUG Whole Care Peppermint Sodium fluoride PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g 51009-166_b5fa22e2-cc30-488b-8527-87ed98a19680 51009-166 HUMAN OTC DRUG Maximum Strength Sensitive Soothing Mint Sodium Fluoride and Potassium Nitrate PASTE, DENTIFRICE DENTAL 20090901 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. POTASSIUM NITRATE; SODIUM FLUORIDE .05; .00243 g/g; g/g 51009-167_09b91597-8edd-4f22-8770-3a2ae93cc4a5 51009-167 HUMAN OTC DRUG Maximum Strength Sensitive True Mint Sodium Fluoride and Potassium Nitrate PASTE, DENTIFRICE DENTAL 20090901 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. POTASSIUM NITRATE; SODIUM FLUORIDE .05; .00243 g/g; g/g 51009-197_b63b75f1-6d22-4920-ae5f-cd9a1bacab3f 51009-197 HUMAN OTC DRUG Sensitive fluoride-free - Wintermint Potassium Nitrate PASTE, DENTIFRICE DENTAL 20090901 OTC MONOGRAPH NOT FINAL part356 Tom's of Maine, Inc. POTASSIUM NITRATE .05 g/g 51009-198_ca0bfc99-fb07-418a-a697-d627885a7107 51009-198 HUMAN OTC DRUG Toms Natural Anticavity Peppermint fights cavities freshens breath strengthens enamel Sodium fluoride PASTE, DENTIFRICE DENTAL 20140101 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g 51009-199_82a79e8e-49e9-41f1-b83e-685efdb96ace 51009-199 HUMAN OTC DRUG Toms Cavity Protection Spearmint Fights cavities / Fresh Breath Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130220 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g 51009-202_3cf8db86-f64f-48c3-bbaa-20035b82cfe1 51009-202 HUMAN OTC DRUG Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20140606 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g 51009-203_2d19f12a-1cb1-4766-9ea7-c694ffc57476 51009-203 HUMAN OTC DRUG Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20140606 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g 51009-205_6eb37d0d-c8a5-44a4-a6c4-cd9d1842c1a7 51009-205 HUMAN OTC DRUG Toms Wicked Fresh Cool Peppermint fresh breath / cavity protection Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20140606 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g 51009-206_cffc1051-b891-47f1-b0e6-eee03ed7bb08 51009-206 HUMAN OTC DRUG Toms Wicked Fresh Spearmint Ice fresh breath / cavity protection Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20140606 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g 51009-207_43932082-d9ce-47cf-8a64-f3d691b27df5 51009-207 HUMAN OTC DRUG Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20140812 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g 51009-208_50c5f792-e0bf-4bb8-b33c-3c675c611034 51009-208 HUMAN OTC DRUG Toms Whole Care Peppermint fights cavities / whitening / fresh breath / helps fight tartar Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20140811 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g 51009-209_76a4c57e-afb9-4556-811b-0b5bf11d331f 51009-209 HUMAN OTC DRUG Toms Natural Enamel Strength Peppermint strengthens enamel / whitening / fights cavities / freshens breath / no artificial dyes or sweeteners Sodium fluoride PASTE, DENTIFRICE DENTAL 20141217 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g 51009-210_a0082742-a915-4dd6-a1e9-c4f426dffad4 51009-210 HUMAN OTC DRUG Toms Cavity Protection Spearmint Fights cavities Fresh Breath Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20141231 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g 51009-211_c767c7f6-afb6-4d06-9d65-7471585f4e12 51009-211 HUMAN OTC DRUG Toms Baking Soda Cavity Protection Peppermint Fights cavities / Fresh Breath Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20141231 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g 51009-238_15428dec-613d-4894-a015-7035b4584509 51009-238 HUMAN OTC DRUG Natural Fluoride Fresh Mint cavity protection whitening fresh breath Sodium fluoride PASTE, DENTIFRICE DENTAL 20120901 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g 51009-248_8a3b9499-da8c-4c43-ad4c-6cb02976d175 51009-248 HUMAN OTC DRUG Simply White clean mint Sodium fluoride PASTE, DENTIFRICE DENTAL 20110829 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g 51009-830_14754960-8e32-4c3c-b41d-f5ed6fdc2c74 51009-830 HUMAN OTC DRUG Childrens Outrageous Orange Mango Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20100830 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g 51009-831_68304e46-924e-4d16-9b01-e2092e4ee74c 51009-831 HUMAN OTC DRUG Naturally Dry Natural Aluminum chlorohydrate STICK CUTANEOUS 20120102 OTC MONOGRAPH FINAL part350 Tom's of Maine, Inc. ALUMINUM CHLOROHYDRATE .22 g/g 51009-832_79c38c6c-7a80-40ff-8c31-c76d228e4bc7 51009-832 HUMAN OTC DRUG Naturally Dry Unscented Aluminum chlorohydrate STICK CUTANEOUS 20120102 OTC MONOGRAPH FINAL part350 Tom's of Maine, Inc. ALUMINUM CHLOROHYDRATE .23 g/g 51009-833_6fc4de03-f24e-4553-87b9-4486c1489c2c 51009-833 HUMAN OTC DRUG Toms Naturally Dry Antiperspirant Deodorant - Fresh Meadow wetness protection Aluminum Chlorohydrate STICK CUTANEOUS 20141115 OTC MONOGRAPH FINAL part350 Tom's of Maine, Inc. ALUMINUM CHLOROHYDRATE .22 g/g 51012-001_83e6149a-9ca7-44e9-a1d7-3fc3debd9b0f 51012-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20090101 UNAPPROVED MEDICAL GAS Gilmore Liquid Air Company OXYGEN 99 L/100L 51012-002_5431f340-4400-4f3f-b37e-fb3e47a89cb3 51012-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20090101 UNAPPROVED MEDICAL GAS Gilmore Liquid Air Company NITROGEN 99 L/100L 51012-003_419dd4c4-4f63-4aaf-ad8e-7432216f73f2 51012-003 HUMAN PRESCRIPTION DRUG AIR AIR GAS RESPIRATORY (INHALATION) 20090101 UNAPPROVED MEDICAL GAS Gilmore Liquid Air Company AIR 20.5 L/100L 51013-105_6efc291d-e1b9-4a4a-8b95-3c88527084e7 51013-105 HUMAN OTC DRUG DayTime ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl CAPSULE, LIQUID FILLED ORAL 20141226 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 51013-106_11c2d5c3-8a03-488b-b656-be399098bfa4 51013-106 HUMAN OTC DRUG NiteTime acetaminophen, dextromethorphan hydrobromide, doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20141226 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 51013-107_cd055a2e-3664-4938-b58d-5176b0b5da37 51013-107 HUMAN OTC DRUG Pain Relief Extra Strength ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20141120 OTC MONOGRAPH NOT FINAL part343 PuraCap Pharmaceutical LLC ACETAMINOPHEN 500 mg/1 51013-111_4ed9097b-a03f-4ef3-81c7-7b8dfd278ea9 51013-111 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM 50 MG DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140822 OTC MONOGRAPH NOT FINAL part334 PuraCap Pharmaceutical LLC DOCUSATE SODIUM 50 mg/1 51021-910_d94d5b66-a130-41a7-b016-d3ce3e348e87 51021-910 HUMAN PRESCRIPTION DRUG Xylon 10 Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20140701 ANDA ANDA076642 Sircle Laboratories, LLC HYDROCODONE BITARTRATE; IBUPROFEN 10; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 51027-0007_ffdaada5-32a4-4b8f-9429-d9bbd41cf4c2 51027-0007 HUMAN OTC DRUG KINKAN ammonia, camphor (natural), menthol LINIMENT TOPICAL 20000426 OTC MONOGRAPH NOT FINAL part348 KINKANDO CO., LTD. AMMONIA; CAMPHOR (NATURAL); MENTHOL 1.15; 1.55; 3 mL/mL; mL/mL; mL/mL 51027-0330_3141708c-a65c-445e-8d3b-227d527ff47c 51027-0330 HUMAN OTC DRUG KINKAN COOL diphenhydramine hydrochloride, menthol LINIMENT TOPICAL 20000426 OTC MONOGRAPH NOT FINAL part348 KINKANDO CO., LTD. DIPHENHYDRAMINE HYDROCHLORIDE; MENTHOL 1; .5 mL/mL; mL/mL 51042-050_58df0085-2488-4ca0-b4d2-0c690905eaae 51042-050 HUMAN OTC DRUG First Mark Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20100625 OTC MONOGRAPH NOT FINAL part333A Performance Food Group TRICLOSAN .3 mL/100mL 51042-689_0686590d-4c92-4b7b-9d6d-1a4c0e16cf2a 51042-689 HUMAN OTC DRUG First Mark Foam Antimicrobial Hand Cleaner Triclosan LIQUID TOPICAL 20100624 OTC MONOGRAPH NOT FINAL part333 Performance Food Group TRICLOSAN .5 mL/100mL 51042-692_9316646c-2f55-413d-988f-def3492502f5 51042-692 HUMAN OTC DRUG First Mark Foaming Hand Cleaner Benzethonium Chloride LIQUID TOPICAL 20100623 OTC MONOGRAPH NOT FINAL part333 Performance Food Group BENZETHONIUM CHLORIDE .2 mL/100mL 51051-001_f0473782-3ef9-4bac-9ed8-022907aa5f2b 51051-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100701 UNAPPROVED MEDICAL GAS Pure Process Medical & Scientific Gases, LLC OXYGEN 990 mL/L 51053-500_7b3f45f7-3757-49d2-8976-a33282db8c4f 51053-500 HUMAN OTC DRUG Alcohol free hand sanitizer BENZALKONIUM CHLORIDE AEROSOL, FOAM TOPICAL 20100524 OTC MONOGRAPH NOT FINAL part352 Sanihealth Products Corporation BENZALKONIUM CHLORIDE 1.2 mL/1000mL 51053-501_7811f85c-d9e6-4ca3-81d7-64773f71f314 51053-501 HUMAN OTC DRUG Antibacterial Foam Chloroxylenol SOAP TOPICAL 20100518 UNAPPROVED DRUG OTHER Sanihealth Products Corporation CHLOROXYLENOL 5 mL/1000mL 51053-502_3231512f-c1f6-4f9f-ba51-77f54c416683 51053-502 HUMAN OTC DRUG Antibacterial Soap chloroxylenol GEL TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 Sanihealth Products Corporation CHLOROXYLENOL 4 mL/800mL 51060-001_87e4e518-724d-4037-8e22-4989066e98b5 51060-001 HUMAN OTC DRUG ReCreate Foundation Porcelain Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL 51060-002_87e4e518-724d-4037-8e22-4989066e98b5 51060-002 HUMAN OTC DRUG ReCreate Foundation Ivory Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL 51060-003_87e4e518-724d-4037-8e22-4989066e98b5 51060-003 HUMAN OTC DRUG ReCreate Foundation Cool Bisque Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL 51060-004_87e4e518-724d-4037-8e22-4989066e98b5 51060-004 HUMAN OTC DRUG ReCreate Foundation Warm Bisque Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL 51060-005_87e4e518-724d-4037-8e22-4989066e98b5 51060-005 HUMAN OTC DRUG ReCreate Foundation Beige Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL 51060-006_87e4e518-724d-4037-8e22-4989066e98b5 51060-006 HUMAN OTC DRUG ReCreate Foundation Cool Sand Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL 51060-007_87e4e518-724d-4037-8e22-4989066e98b5 51060-007 HUMAN OTC DRUG ReCreate Foundation Warm Sand Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL 51060-008_87e4e518-724d-4037-8e22-4989066e98b5 51060-008 HUMAN OTC DRUG ReCreate Foundation Natural Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL 51060-009_87e4e518-724d-4037-8e22-4989066e98b5 51060-009 HUMAN OTC DRUG ReCreate Foundation Honey Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL 51060-010_87e4e518-724d-4037-8e22-4989066e98b5 51060-010 HUMAN OTC DRUG ReCreate Foundation Warm Walnut Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL 51060-011_87e4e518-724d-4037-8e22-4989066e98b5 51060-011 HUMAN OTC DRUG ReCreate Foundation Walnut Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL 51060-012_87e4e518-724d-4037-8e22-4989066e98b5 51060-012 HUMAN OTC DRUG ReCreate Foundation Chestnut Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL 51060-017_ea095aa8-60aa-43ea-a621-63d4ab810173 51060-017 HUMAN OTC DRUG Amazonian clay BB illuminating moisturizer Broad Spectrum SPF 15 Sunscreen Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 75; 30; 50 mg/mL; mg/mL; mg/mL 51060-018_c101e35b-ba30-4654-8cc5-44a121222800 51060-018 HUMAN OTC DRUG BB Tinted Treatment 12-hour Primer Broad Spectrum SPF 30 Sunscreen Fair Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 45.5; 35 mg/mL; mg/mL 51060-019_c101e35b-ba30-4654-8cc5-44a121222800 51060-019 HUMAN OTC DRUG BB Tinted Treatment 12-hour Primer Broad Spectrum SPF 30 Sunscreen Light Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 45.5; 35 mg/mL; mg/mL 51060-020_c101e35b-ba30-4654-8cc5-44a121222800 51060-020 HUMAN OTC DRUG BB Tinted Treatment 12-hour Primer Broad Spectrum SPF 30 Sunscreen Medium Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 45.5; 35 mg/mL; mg/mL 51060-021_c101e35b-ba30-4654-8cc5-44a121222800 51060-021 HUMAN OTC DRUG BB Tinted Treatment 12-hour Primer Broad Spectrum SPF 30 Sunscreen Medium-Tan Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 45.5; 35 mg/mL; mg/mL 51060-022_c101e35b-ba30-4654-8cc5-44a121222800 51060-022 HUMAN OTC DRUG BB Tinted Treatment 12-hour Primer Broad Spectrum SPF 30 Sunscreen Tan Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 45.5; 35 mg/mL; mg/mL 51060-023_c101e35b-ba30-4654-8cc5-44a121222800 51060-023 HUMAN OTC DRUG BB Tinted Treatment 12-hour Primer Broad Spectrum SPF 30 Sunscreen Tan Deep Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 45.5; 35 mg/mL; mg/mL 51060-024_f4253ee1-05c9-4398-b9f7-0531559fd9c2 51060-024 HUMAN OTC DRUG Beyond BB Perfecting Foundation Broad Spectrum SPF 15 Sunscreen Fair Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-025_f4253ee1-05c9-4398-b9f7-0531559fd9c2 51060-025 HUMAN OTC DRUG Beyond BB Perfecting Foundation Broad Spectrum SPF 15 Sunscreen Light Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-026_f4253ee1-05c9-4398-b9f7-0531559fd9c2 51060-026 HUMAN OTC DRUG Beyond BB Perfecting Foundation Broad Spectrum SPF 15 Sunscreen Medium Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-027_f4253ee1-05c9-4398-b9f7-0531559fd9c2 51060-027 HUMAN OTC DRUG Beyond BB Perfecting Foundation Broad Spectrum SPF 15 Sunscreen Tan Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-028_f4253ee1-05c9-4398-b9f7-0531559fd9c2 51060-028 HUMAN OTC DRUG Beyond BB Perfecting Foundation Broad Spectrum SPF 15 Sunscreen Deep Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-029_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-029 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Ivory Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL 51060-030_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-030 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Fair Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL 51060-031_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-031 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Beige Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL 51060-032_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-032 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Light Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL 51060-033_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-033 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Warm Beige Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL 51060-034_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-034 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Light-Medium Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL 51060-035_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-035 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Medium Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL 51060-036_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-036 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Medium-Tan Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL 51060-037_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-037 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Tan Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL 51060-038_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-038 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Deep Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL 51060-039_7af83dff-cee0-42b2-9520-9c3e2a04623c 51060-039 HUMAN OTC DRUG Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Fair Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL 51060-040_7af83dff-cee0-42b2-9520-9c3e2a04623c 51060-040 HUMAN OTC DRUG Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivory Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL 51060-041_7af83dff-cee0-42b2-9520-9c3e2a04623c 51060-041 HUMAN OTC DRUG Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Light Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL 51060-042_7af83dff-cee0-42b2-9520-9c3e2a04623c 51060-042 HUMAN OTC DRUG Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Light-Medium Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL 51060-043_7af83dff-cee0-42b2-9520-9c3e2a04623c 51060-043 HUMAN OTC DRUG Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Medium Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL 51060-044_7af83dff-cee0-42b2-9520-9c3e2a04623c 51060-044 HUMAN OTC DRUG Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Medium-Tan Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL 51060-045_7af83dff-cee0-42b2-9520-9c3e2a04623c 51060-045 HUMAN OTC DRUG Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Tan Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL 51060-046_7af83dff-cee0-42b2-9520-9c3e2a04623c 51060-046 HUMAN OTC DRUG Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Tan-Deep Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL 51060-047_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-047 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Deep Sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-048_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-048 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Fair Beige Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-049_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-049 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Fair Sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-050_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-050 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Fair- Light Honey Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-051_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-051 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Ivory Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-052_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-052 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Light Beige Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-053_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-053 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Light Neutral Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-054_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-054 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Light Sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-055_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-055 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Light-Medium Beige Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-056_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-056 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Light-Medium Honey Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-057_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-057 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Light-Medium Sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-058_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-058 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Medium Honey Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-059_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-059 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Medium Sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-060_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-060 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Medium-Tan Honey Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-061_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-061 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Tan Honey Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-062_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-062 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Tan-Deep Sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-063_716da22b-0f3a-4ff3-8a11-3f8c44d08aa6 51060-063 HUMAN OTC DRUG Amazonian Colored Clay Foundation Broad Spectrum SPF 15 Sunscreen Fair Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 40 mg/mL; mg/mL 51060-064_716da22b-0f3a-4ff3-8a11-3f8c44d08aa6 51060-064 HUMAN OTC DRUG Amazonian Colored Clay Foundation Broad Spectrum SPF 15 Sunscreen Light Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 40 mg/mL; mg/mL 51060-065_716da22b-0f3a-4ff3-8a11-3f8c44d08aa6 51060-065 HUMAN OTC DRUG Amazonian Colored Clay Foundation Broad Spectrum SPF 15 Sunscreen Medium Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 40 mg/mL; mg/mL 51060-066_716da22b-0f3a-4ff3-8a11-3f8c44d08aa6 51060-066 HUMAN OTC DRUG Amazonian Colored Clay Foundation Broad Spectrum SPF 15 Sunscreen Tan Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 40 mg/mL; mg/mL 51060-067_716da22b-0f3a-4ff3-8a11-3f8c44d08aa6 51060-067 HUMAN OTC DRUG Amazonian Colored Clay Foundation Broad Spectrum SPF 15 Sunscreen Deep Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 40 mg/mL; mg/mL 51060-068_7c6b6360-e61a-4a83-aad0-58e47f178ed8 51060-068 HUMAN OTC DRUG foundcealer 2-in-1 foundation and concealer Broad Spectrum SPF 15 Sunscreen fair Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-069_7c6b6360-e61a-4a83-aad0-58e47f178ed8 51060-069 HUMAN OTC DRUG foundcealer 2-in-1 foundation and concealer Broad Spectrum SPF 15 Sunscreen light Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-070_7c6b6360-e61a-4a83-aad0-58e47f178ed8 51060-070 HUMAN OTC DRUG foundcealer 2-in-1 foundation and concealer Broad Spectrum SPF 15 Sunscreen light-medium Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-071_7c6b6360-e61a-4a83-aad0-58e47f178ed8 51060-071 HUMAN OTC DRUG foundcealer 2-in-1 foundation and concealer Broad Spectrum SPF 15 Sunscreen medium Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-072_7c6b6360-e61a-4a83-aad0-58e47f178ed8 51060-072 HUMAN OTC DRUG foundcealer 2-in-1 foundation and concealer Broad Spectrum SPF 15 Sunscreen tan Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51060-073_7c6b6360-e61a-4a83-aad0-58e47f178ed8 51060-073 HUMAN OTC DRUG foundcealer 2-in-1 foundation and concealer Broad Spectrum SPF 15 Sunscreen deep Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51068-501_4dc9e50c-d4e6-4fd9-9e6e-cc904ed19110 51068-501 HUMAN OTC DRUG ActivOn Ultra Strength Arthritis Menthol and Histamine Dihydrochloride STICK TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part348 Family First Pharmaceuticals, Inc. HISTAMINE DIHYDROCHLORIDE; MENTHOL .00028; .04574 g/g; g/g 51068-503_2ab5e94f-2b75-48bc-98d5-81e71f64227b 51068-503 HUMAN OTC DRUG ActivOn Ultra Strength Joint and Muscle Menthol STICK TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part348 Family First Pharmaceuticals, Inc. MENTHOL .05138 g/g 51069-0001_fe84aac7-73c6-423a-bb56-e8229192a1ee 51069-0001 HUMAN OTC DRUG Metabolic Support Asclepias vincetoxicum, Echinacea, Hypothalamus (suis), Brain (suis), Hepar suis, Methylcobalamin, Pancreas suis, Renal (suis), Stomach (suis), AACG-A, LIQUID ORAL 20120906 UNAPPROVED HOMEOPATHIC Seriously Slim 7-OXO-PRASTERONE; ADENOSINE TRIPHOSPHATE; APC-356433; APC-356434; CYNANCHUM VINCETOXICUM ROOT; ECHINACEA, UNSPECIFIED; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GLUCAGON; GRAPHITE; INSULIN PORK; LACTIC ACID, L-; METHYLCOBALAMIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; PORK BRAIN; PORK KIDNEY; PORK LIVER; PROTEUS INCONSTANS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PANCREAS; SUS SCROFA STOMACH 30; 30; 8; 8; 6; 6; 12; 12; 30; 12; 30; 30; 8; 12; 12; 8; 8; 8; 30; 12; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 51072-065_03c2e772-ef9f-5a69-e054-00144ff88e88 51072-065 HUMAN OTC DRUG Pyrantel Pamoate Pyrantel Pamoate SUSPENSION ORAL 20130419 OTC MONOGRAPH FINAL part357B Aurora Pharmaceutical LLC PYRANTEL PAMOATE 5 g/100mL 51073-801_7d0fd474-61ea-40c3-bf22-d17e903c29ff 51073-801 HUMAN OTC DRUG Health and Beyond Antiseptic Hand Sanitizer ETHYL ALCOHOL SPRAY TOPICAL 20110609 OTC MONOGRAPH NOT FINAL part333E Suzhou Health and Beyond Hygienic Products Inc. ALCOHOL 62 mL/100mL 51079-007_601d9cfa-ec8e-43b6-a0e2-6489ef0a2fc5 51079-007 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20121114 ANDA ANDA075876 Mylan Institutional Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 51079-020_d361c2ed-99e8-4089-bbba-cbcf2b239228 51079-020 HUMAN PRESCRIPTION DRUG Budesonide budesonide CAPSULE ORAL 20110920 ANDA ANDA090410 UDL Laboratories, Inc. BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51079-023_c42a0e21-15b8-4cbe-8625-6a8f5fd0c226 51079-023 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20050415 ANDA ANDA076698 Mylan Institutional Inc. METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 51079-024_c42a0e21-15b8-4cbe-8625-6a8f5fd0c226 51079-024 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20050201 ANDA ANDA076698 Mylan Institutional Inc. METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 51079-027_738b8ff3-97d8-45be-a9f2-9a1c1b27f394 51079-027 HUMAN PRESCRIPTION DRUG Quinidine Gluconate Quinidine Gluconate TABLET, EXTENDED RELEASE ORAL 20110823 ANDA ANDA089338 UDL Laboratories, Inc. QUINIDINE GLUCONATE 324 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] 51079-028_5f742224-618e-4f4c-bdec-7693be99c697 51079-028 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20101104 ANDA ANDA090596 UDL Laboratories, Inc. TACROLIMUS 5 mg/1 51079-034_c79ff834-dba9-45f7-9378-0aab6c858818 51079-034 HUMAN PRESCRIPTION DRUG Levofloxacin levofloxacin TABLET, FILM COATED ORAL 20120827 ANDA ANDA076276 Mylan Institutional Inc. LEVOFLOXACIN 250 mg/1 51079-035_c79ff834-dba9-45f7-9378-0aab6c858818 51079-035 HUMAN PRESCRIPTION DRUG Levofloxacin levofloxacin TABLET, FILM COATED ORAL 20120827 ANDA ANDA076276 Mylan Institutional Inc. LEVOFLOXACIN 500 mg/1 51079-047_8670d405-7556-42d6-acbe-938294f42716 51079-047 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110323 ANDA ANDA090942 Mylan Institutional Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 51079-051_ab795c1d-1427-43d6-ae58-b8fb5efa1ae6 51079-051 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20120905 ANDA ANDA090970 Mylan Institutional Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 51079-058_e07c7c15-b950-4817-bc82-1a65798b2404 51079-058 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 20130503 ANDA ANDA086831 Mylan Institutional Inc. CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 51079-062_7ab4bdd1-84b0-44fc-92bf-0a48a16fca12 51079-062 HUMAN PRESCRIPTION DRUG Repaglinide repaglinide TABLET ORAL 20131121 ANDA ANDA090252 Mylan Institutional Inc. REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 51079-067_24c23508-af39-4ffd-88dd-c72c536ec69c 51079-067 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20130514 ANDA ANDA085762 Mylan Institutional Inc. ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 51079-072_fea5aa65-b24a-4dc2-9301-873979a91bfd 51079-072 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19970206 NDA NDA018487 Mylan Institutional Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 51079-073_fea5aa65-b24a-4dc2-9301-873979a91bfd 51079-073 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19970206 NDA NDA018487 Mylan Institutional Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 51079-074_86e7b521-310c-46b3-8970-fde3630cbea1 51079-074 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20071226 ANDA ANDA089097 Mylan Institutional Inc. HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 51079-075_86e7b521-310c-46b3-8970-fde3630cbea1 51079-075 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20071226 ANDA ANDA088467 Mylan Institutional Inc. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 51079-076_86e7b521-310c-46b3-8970-fde3630cbea1 51079-076 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20071226 ANDA ANDA088468 Mylan Institutional Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 51079-077_7c79dda0-f5dc-42ac-9862-a8ce3ff2dcd6 51079-077 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20071126 ANDA ANDA088496 Mylan Institutional Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 51079-078_7c79dda0-f5dc-42ac-9862-a8ce3ff2dcd6 51079-078 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20071126 ANDA ANDA088487 Mylan Institutional Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 51079-083_a3284647-5eb1-4f9d-b14f-3f357ed0e3eb 51079-083 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19940609 ANDA ANDA080937 Mylan Institutional Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] 51079-086_a9da4224-dcb9-4e5b-82c8-ffed5b1d86eb 51079-086 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030801 ANDA ANDA076122 Mylan Institutional Inc. MIRTAZAPINE 15 mg/1 51079-087_a9da4224-dcb9-4e5b-82c8-ffed5b1d86eb 51079-087 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030801 ANDA ANDA076122 Mylan Institutional Inc. MIRTAZAPINE 30 mg/1 51079-088_a9da4224-dcb9-4e5b-82c8-ffed5b1d86eb 51079-088 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030801 ANDA ANDA076122 Mylan Institutional Inc. MIRTAZAPINE 45 mg/1 51079-089_7866929d-2b76-441c-87a6-4263be68dfcb 51079-089 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 20110513 ANDA ANDA087127 UDL Laboratories, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 51079-090_7866929d-2b76-441c-87a6-4263be68dfcb 51079-090 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 20110513 ANDA ANDA087128 UDL Laboratories, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 51079-093_11e47261-bf78-4c7b-9158-98045735c21f 51079-093 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20120925 ANDA ANDA078518 Mylan Institutional Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 51079-103_7e1a8152-941a-4aa4-bcb0-83c04905678f 51079-103 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20110204 ANDA ANDA040424 UDL Laboratories, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 51079-104_99276a7d-591d-4de4-bcac-e9bd53f8dc0e 51079-104 HUMAN PRESCRIPTION DRUG Spironolactone and Hydrochlorothiazide spironolactone and hydrochlorothiazide TABLET ORAL 20110823 ANDA ANDA086513 UDL Laboratories, Inc. HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 25; 25 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51079-105_d7bc46a5-ac1e-47f2-88f3-3351fdbbdbf4 51079-105 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20110421 ANDA ANDA040756 Mylan Institutional Inc. FOLIC ACID 1 mg/1 51079-107_888b29b1-48d0-4c4e-b0ac-506ea65020e1 51079-107 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 20130313 ANDA ANDA086009 Mylan Institutional Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 51079-109_8670d405-7556-42d6-acbe-938294f42716 51079-109 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110718 ANDA ANDA090942 Mylan Institutional Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 51079-118_384713c2-3608-447b-bdca-f4f7f97d2a49 51079-118 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride CAPSULE ORAL 19991201 ANDA ANDA040319 Mylan Institutional Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 51079-119_384713c2-3608-447b-bdca-f4f7f97d2a49 51079-119 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride TABLET ORAL 19980306 ANDA ANDA040317 Mylan Institutional Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 51079-121_96d05f9d-00b1-486d-8984-302cd157c8cf 51079-121 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20091201 ANDA ANDA090763 Mylan Institutional Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 51079-122_ecae5b69-36da-4737-bacd-fc6d04df960f 51079-122 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20111006 ANDA ANDA070035 UDL Laboratories, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 51079-126_ecae5b69-36da-4737-bacd-fc6d04df960f 51079-126 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20111006 ANDA ANDA070044 UDL Laboratories, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 51079-128_002e3d65-894e-4778-8945-01e71e29e288 51079-128 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20110818 ANDA ANDA071017 UDL Laboratories, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 51079-129_4e97b46f-015e-492a-ae84-d7049f6b91d9 51079-129 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin TABLET, CHEWABLE ORAL 20130215 ANDA ANDA200691 Mylan Institutional Inc. PHENYTOIN 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51079-130_b49ba844-f140-4b42-b63b-f4d085943693 51079-130 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20130408 ANDA ANDA084113 Mylan Institutional Inc. CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-131_888b29b1-48d0-4c4e-b0ac-506ea65020e1 51079-131 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 20130313 ANDA ANDA086009 Mylan Institutional Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 51079-133_888b29b1-48d0-4c4e-b0ac-506ea65020e1 51079-133 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 20130313 ANDA ANDA086009 Mylan Institutional Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 51079-141_100ac52f-df16-421b-9ec5-717608b21da8 51079-141 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19940506 ANDA ANDA084769 Mylan Institutional Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-142_7b11c314-9427-4d77-bfbe-22222230d4da 51079-142 HUMAN PRESCRIPTION DRUG Lithium Carbonate lithium carbonate TABLET, EXTENDED RELEASE ORAL 20120420 ANDA ANDA202219 Mylan Institutional Inc. LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] 51079-145_725d7c35-ff1b-4fad-bee3-766a9ea6de51 51079-145 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040521 ANDA ANDA076430 Mylan Institutional Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 51079-146_725d7c35-ff1b-4fad-bee3-766a9ea6de51 51079-146 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040521 ANDA ANDA076430 Mylan Institutional Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 51079-147_888b29b1-48d0-4c4e-b0ac-506ea65020e1 51079-147 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 20130313 ANDA ANDA086009 Mylan Institutional Inc. AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 51079-149_35cb5b37-bbd6-4951-9f8d-b3b8f7815268 51079-149 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline TABLET, FILM COATED ORAL 20120806 ANDA ANDA078626 Mylan Institutional Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51079-150_35cb5b37-bbd6-4951-9f8d-b3b8f7815268 51079-150 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline TABLET, FILM COATED ORAL 20120806 ANDA ANDA078626 Mylan Institutional Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51079-151_35cb5b37-bbd6-4951-9f8d-b3b8f7815268 51079-151 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline TABLET, FILM COATED ORAL 20120806 ANDA ANDA078626 Mylan Institutional Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51079-152_e24a692e-0dd5-4637-bb3b-bca2538870da 51079-152 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, FILM COATED ORAL 20120608 ANDA ANDA076866 Mylan Institutional Inc. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 51079-153_e24a692e-0dd5-4637-bb3b-bca2538870da 51079-153 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, FILM COATED ORAL 20120608 ANDA ANDA076866 Mylan Institutional Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 51079-154_e24a692e-0dd5-4637-bb3b-bca2538870da 51079-154 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, FILM COATED ORAL 20120608 ANDA ANDA076866 Mylan Institutional Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 51079-155_e24a692e-0dd5-4637-bb3b-bca2538870da 51079-155 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, FILM COATED ORAL 20120608 ANDA ANDA076866 Mylan Institutional Inc. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 51079-156_e24a692e-0dd5-4637-bb3b-bca2538870da 51079-156 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, FILM COATED ORAL 20120608 ANDA ANDA076866 Mylan Institutional Inc. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 51079-161_14c5508e-d488-4ca3-b3af-a2d1d0c56204 51079-161 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19961223 ANDA ANDA088628 Mylan Institutional Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 51079-169_e8671514-37f6-4884-ad24-ee32aca098d6 51079-169 HUMAN PRESCRIPTION DRUG Metoprolol Succinate metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120905 ANDA ANDA202033 Mylan Institutional Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51079-170_e8671514-37f6-4884-ad24-ee32aca098d6 51079-170 HUMAN PRESCRIPTION DRUG Metoprolol Succinate metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120905 ANDA ANDA202033 Mylan Institutional Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51079-171_e8671514-37f6-4884-ad24-ee32aca098d6 51079-171 HUMAN PRESCRIPTION DRUG Metoprolol Succinate metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120905 ANDA ANDA202033 Mylan Institutional Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51079-172_9df53fff-ebcd-4b21-9304-416e1e98fccb 51079-172 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20120817 ANDA ANDA075973 Mylan Institutional Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 51079-173_9df53fff-ebcd-4b21-9304-416e1e98fccb 51079-173 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20120702 ANDA ANDA075973 Mylan Institutional Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 51079-174_9df53fff-ebcd-4b21-9304-416e1e98fccb 51079-174 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20121005 ANDA ANDA075973 Mylan Institutional Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 51079-180_1ee4c3e6-491a-4c46-b45b-8eed250e5a4f 51079-180 HUMAN PRESCRIPTION DRUG Lithium Carbonate lithium carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120810 ANDA ANDA202288 Mylan Institutional Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 51079-182_b774448c-a915-4219-a140-5159cbcae82a 51079-182 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED ORAL 20110411 ANDA ANDA075817 Mylan Institutional Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 51079-190_77eb7770-e405-4fac-8c93-931ed015ddbd 51079-190 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 20120803 NDA NDA018858 Mylan Institutional Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51079-191_77eb7770-e405-4fac-8c93-931ed015ddbd 51079-191 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 20120803 ANDA ANDA070624 Mylan Institutional Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51079-192_008743b7-7cc8-4399-b9e2-86d6b9268beb 51079-192 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130506 ANDA ANDA078020 Mylan Institutional Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 51079-193_008743b7-7cc8-4399-b9e2-86d6b9268beb 51079-193 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130506 ANDA ANDA078020 Mylan Institutional Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51079-194_008743b7-7cc8-4399-b9e2-86d6b9268beb 51079-194 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130506 ANDA ANDA078020 Mylan Institutional Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51079-195_3152797a-4bfd-4a5d-9ed2-037e79416842 51079-195 HUMAN PRESCRIPTION DRUG Fenofibric Acid fenofibric acid CAPSULE, DELAYED RELEASE PELLETS ORAL 20131121 ANDA ANDA200913 Mylan Institutional Inc. FENOFIBRIC ACID 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 51079-196_3152797a-4bfd-4a5d-9ed2-037e79416842 51079-196 HUMAN PRESCRIPTION DRUG Fenofibric Acid fenofibric acid CAPSULE, DELAYED RELEASE PELLETS ORAL 20131121 ANDA ANDA200913 Mylan Institutional Inc. FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 51079-197_205b572b-dc91-48db-829e-179bade6b0ea 51079-197 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20140128 ANDA ANDA201486 Mylan Institutional Inc. TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 51079-198_205b572b-dc91-48db-829e-179bade6b0ea 51079-198 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20140129 ANDA ANDA201486 Mylan Institutional Inc. TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 51079-200_bcf5aeda-65d5-4520-a079-5df3061a4a7b 51079-200 HUMAN PRESCRIPTION DRUG Methyldopa methyldopa TABLET ORAL 20121212 ANDA ANDA070076 Mylan Institutional Inc. METHYLDOPA 250 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 51079-201_bcf5aeda-65d5-4520-a079-5df3061a4a7b 51079-201 HUMAN PRESCRIPTION DRUG Methyldopa methyldopa TABLET ORAL 20121212 ANDA ANDA070076 Mylan Institutional Inc. METHYLDOPA 500 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 51079-204_f1f55766-cd2e-499e-bdd6-fec376db9bed 51079-204 HUMAN PRESCRIPTION DRUG Abacavir Sulfate abacavir sulfate TABLET, FILM COATED ORAL 20120801 ANDA ANDA091294 Mylan Institutional Inc. ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 51079-205_8a3b666f-8910-4a3b-95e2-818c4bb9e4f9 51079-205 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20130408 ANDA ANDA018659 Mylan Institutional Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 51079-206_8a3b666f-8910-4a3b-95e2-818c4bb9e4f9 51079-206 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20130408 ANDA ANDA018659 Mylan Institutional Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 51079-208_7c1083b9-7a20-475d-ba12-4f5d0b53e601 51079-208 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20140130 ANDA ANDA091226 Mylan Institutional Inc. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51079-209_7c1083b9-7a20-475d-ba12-4f5d0b53e601 51079-209 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20140129 ANDA ANDA091226 Mylan Institutional Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51079-210_7c1083b9-7a20-475d-ba12-4f5d0b53e601 51079-210 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20140129 ANDA ANDA091226 Mylan Institutional Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51079-211_7c1083b9-7a20-475d-ba12-4f5d0b53e601 51079-211 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20140123 ANDA ANDA091226 Mylan Institutional Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51079-216_7ffffa48-74aa-4de2-96a3-4feaa18b96d4 51079-216 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20121011 ANDA ANDA070035 Mylan Institutional Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 51079-217_7ffffa48-74aa-4de2-96a3-4feaa18b96d4 51079-217 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20121011 ANDA ANDA070044 Mylan Institutional Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 51079-223_932e66a6-899d-4d60-9f3c-f659b7d1ca74 51079-223 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, FILM COATED ORAL 20120829 ANDA ANDA079103 Mylan Institutional Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 51079-224_954e1fc5-d986-41f3-8f7f-dd8430f5ca77 51079-224 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 20100604 ANDA ANDA075281 Mylan Institutional Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51079-235_24dce9a2-f25e-4f8c-aaf5-caf461fbee96 51079-235 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate tolterodine TABLET, FILM COATED ORAL 20130214 ANDA ANDA202641 Mylan Institutional Inc. TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 51079-241_e7dcb7fd-52be-46d5-9e4e-24b83f8730c5 51079-241 HUMAN PRESCRIPTION DRUG Acamprosate Calcium acamprosate calcium enteric-coated TABLET, DELAYED RELEASE ORAL 20141022 ANDA ANDA200142 Mylan Institutional Inc. ACAMPROSATE CALCIUM 333 mg/1 51079-246_3f24b3e7-dee4-4045-b10c-5d3126f916d8 51079-246 HUMAN OTC DRUG Loratadine loratadine TABLET ORAL 20130430 ANDA ANDA076154 Mylan Institutional Inc. LORATADINE 10 mg/1 51079-247_fc78c074-3ca8-4e29-9c18-8fab97558fc2 51079-247 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 20130307 ANDA ANDA071293 Mylan Institutional Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 51079-255_b45e90f7-8725-45ca-9492-786c30f57048 51079-255 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20120831 ANDA ANDA076704 Mylan Institutional Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51079-273_82fb6c54-3571-4ea1-9a1b-c21418133e84 51079-273 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20131212 NDA AUTHORIZED GENERIC NDA020796 Mylan Institutional Inc. ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 51079-277_8f89fc32-4aae-4e0a-8657-6fce270f343f 51079-277 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20110920 ANDA ANDA070213 UDL Laboratories, Inc. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51079-278_8f89fc32-4aae-4e0a-8657-6fce270f343f 51079-278 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20110920 ANDA ANDA070213 UDL Laboratories, Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51079-279_8f89fc32-4aae-4e0a-8657-6fce270f343f 51079-279 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20110920 ANDA ANDA070213 UDL Laboratories, Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51079-283_cafb55ed-f2fb-4462-8b5c-c0e34cd83cbc 51079-283 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20110823 ANDA ANDA070184 UDL Laboratories, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 51079-284_36fd138f-3542-4ee1-a8cd-67c1002e9b52 51079-284 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20091120 ANDA ANDA070325 Mylan Institutional Inc. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-285_36fd138f-3542-4ee1-a8cd-67c1002e9b52 51079-285 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20091120 ANDA ANDA070325 Mylan Institutional Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-286_36fd138f-3542-4ee1-a8cd-67c1002e9b52 51079-286 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20091120 ANDA ANDA070325 Mylan Institutional Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-294_edbfe45f-2474-425b-90b9-a5433bb9ddc6 51079-294 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20121228 ANDA ANDA090408 Mylan Institutional Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 51079-298_17e2edb6-e8e2-434b-a5b5-14e53a0b752b 51079-298 HUMAN PRESCRIPTION DRUG Valproic Acid valproic acid CAPSULE ORAL 20120810 ANDA ANDA073229 Mylan Institutional Inc. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 51079-299_df8d4b33-3d6c-4c33-82f9-addcf7666adb 51079-299 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20130320 ANDA ANDA070317 Mylan Institutional Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 51079-300_df8d4b33-3d6c-4c33-82f9-addcf7666adb 51079-300 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20130320 ANDA ANDA070317 Mylan Institutional Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 51079-301_df8d4b33-3d6c-4c33-82f9-addcf7666adb 51079-301 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20130320 ANDA ANDA070317 Mylan Institutional Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 51079-306_219bcbc4-b84a-4209-9f34-ef2b0ef0d273 51079-306 HUMAN OTC DRUG Polyethylene Glycol (3350) polyethylene glycol (3350) POWDER, FOR SOLUTION ORAL 20091120 ANDA ANDA078915 UDL Laboratories Inc POLYETHYLENE GLYCOL 3500 17 g/17g 51079-323_f881ec1a-d330-41d8-b633-143875c06ea4 51079-323 HUMAN PRESCRIPTION DRUG Anastrozole anastrozole TABLET, FILM COATED ORAL 20100723 ANDA ANDA091051 UDL Laboratories, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 51079-345_c2827271-eac2-456c-81b8-ebd06fe23aa8 51079-345 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20120919 ANDA ANDA091537 Mylan Institutional Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 51079-346_c2827271-eac2-456c-81b8-ebd06fe23aa8 51079-346 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20120919 ANDA ANDA091537 Mylan Institutional Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 51079-347_c2827271-eac2-456c-81b8-ebd06fe23aa8 51079-347 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20120919 ANDA ANDA091537 Mylan Institutional Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 51079-348_fcb1b274-3e3c-4ac0-b92c-6b90658357c5 51079-348 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/Macrocrystals Nitrofurantoin Monohydrate/Nitrofurantoin, macrocrystalline CAPSULE ORAL 20070212 ANDA ANDA076648 Mylan Institutional Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 51079-349_5995098b-c770-4c2d-ac0c-7588484dff18 51079-349 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20141111 ANDA ANDA091151 Mylan Institutional Inc. ESZOPICLONE 2 mg/1 CIV 51079-351_07513379-6025-41e3-9d0c-d0a48a73b3ae 51079-351 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20140930 ANDA ANDA202395 Mylan Institutional Inc. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 51079-352_07513379-6025-41e3-9d0c-d0a48a73b3ae 51079-352 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20140930 ANDA ANDA202395 Mylan Institutional Inc. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 51079-353_07513379-6025-41e3-9d0c-d0a48a73b3ae 51079-353 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20140930 ANDA ANDA202395 Mylan Institutional Inc. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 51079-354_07513379-6025-41e3-9d0c-d0a48a73b3ae 51079-354 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20140930 ANDA ANDA202395 Mylan Institutional Inc. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 51079-374_100ac52f-df16-421b-9ec5-717608b21da8 51079-374 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19951208 ANDA ANDA084768 Mylan Institutional Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-375_100ac52f-df16-421b-9ec5-717608b21da8 51079-375 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19960305 ANDA ANDA083116 Mylan Institutional Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-379_6882a448-442a-4286-84dd-ebeade6528f6 51079-379 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil mycophenolate mofetil TABLET, FILM COATED ORAL 20090601 ANDA ANDA065521 Mylan Institutional Inc. MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 51079-383_05243d8f-9057-46a9-ae50-6e16ba6cd7dc 51079-383 HUMAN PRESCRIPTION DRUG Ursodiol ursodiol CAPSULE ORAL 20100527 ANDA ANDA090530 UDL Laboratories, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 51079-385_769f2d6e-21be-4563-9990-a60d13b7e0b2 51079-385 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19950928 ANDA ANDA070541 Mylan Institutional Inc. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 51079-386_d4b1de13-ba1e-417a-8917-04356c10c358 51079-386 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20061229 ANDA ANDA077657 Mylan Institutional Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-387_d4b1de13-ba1e-417a-8917-04356c10c358 51079-387 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20061228 ANDA ANDA077657 Mylan Institutional Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-391_01ff71cc-c881-4b45-a624-5e91713d1778 51079-391 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100528 ANDA ANDA090325 Mylan Institutional Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 51079-392_01ff71cc-c881-4b45-a624-5e91713d1778 51079-392 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100528 ANDA ANDA090325 Mylan Institutional Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 51079-400_09f0f7a8-afef-4191-922d-df9922862967 51079-400 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100913 ANDA ANDA090649 Mylan Institutional Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 51079-409_aef9fda6-f9dd-43a2-a741-6b163a9f4781 51079-409 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20121227 ANDA ANDA091226 Mylan Institutional Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51079-410_aef9fda6-f9dd-43a2-a741-6b163a9f4781 51079-410 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20121227 ANDA ANDA091226 Mylan Institutional Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51079-411_aef9fda6-f9dd-43a2-a741-6b163a9f4781 51079-411 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20121227 ANDA ANDA091226 Mylan Institutional Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51079-412_aef9fda6-f9dd-43a2-a741-6b163a9f4781 51079-412 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20121227 ANDA ANDA091226 Mylan Institutional Inc. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51079-414_5995098b-c770-4c2d-ac0c-7588484dff18 51079-414 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20141111 ANDA ANDA091151 Mylan Institutional Inc. ESZOPICLONE 3 mg/1 CIV 51079-417_d4b1de13-ba1e-417a-8917-04356c10c358 51079-417 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20040315 ANDA ANDA077657 Mylan Institutional Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-418_a4a2e4e3-6213-4d72-bbdc-7c1447283e2b 51079-418 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20110204 ANDA ANDA070920 UDL Laboratories, Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-419_a4a2e4e3-6213-4d72-bbdc-7c1447283e2b 51079-419 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20110204 ANDA ANDA070920 UDL Laboratories, Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-423_02d9c1dc-a0a2-43b5-bb12-cd8ab03b2061 51079-423 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20141013 ANDA ANDA202640 Mylan Institutional Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 51079-425_85cbba14-ab8e-43b1-9f7d-3a0e6a28b0fc 51079-425 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20101104 ANDA ANDA077624 UDL Laboratories, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 51079-426_85cbba14-ab8e-43b1-9f7d-3a0e6a28b0fc 51079-426 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20101104 ANDA ANDA077624 UDL Laboratories, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 51079-431_5a7392d3-dcf6-4af2-9af9-687ec13c45a7 51079-431 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20120925 ANDA ANDA070278 Mylan Institutional Inc. HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] 51079-433_53b6f198-e4a7-4505-9672-efb8c64073ae 51079-433 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20110922 NDA NDA019129 UDL Laboratories, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51079-434_3ff650c9-5665-4fa3-8163-f8eed8dcb1bd 51079-434 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 20110513 ANDA ANDA074621 UDL Laboratories, Inc. MEGESTROL ACETATE 20 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 51079-435_3ff650c9-5665-4fa3-8163-f8eed8dcb1bd 51079-435 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 20110513 ANDA ANDA074621 UDL Laboratories, Inc. MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 51079-436_7b10def3-8980-4d60-8545-d1afb70e52f0 51079-436 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19981001 ANDA ANDA070791 Mylan Institutional Inc. DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 51079-437_7b10def3-8980-4d60-8545-d1afb70e52f0 51079-437 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19981001 ANDA ANDA070791 Mylan Institutional Inc. DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 51079-438_7b10def3-8980-4d60-8545-d1afb70e52f0 51079-438 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19981001 ANDA ANDA070791 Mylan Institutional Inc. DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 51079-440_8b1c22cb-18f7-4c42-b7bb-e5947768c3ba 51079-440 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20070205 ANDA ANDA076187 Mylan Institutional Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51079-441_8b1c22cb-18f7-4c42-b7bb-e5947768c3ba 51079-441 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20070205 ANDA ANDA076187 Mylan Institutional Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51079-442_8b1c22cb-18f7-4c42-b7bb-e5947768c3ba 51079-442 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20070205 ANDA ANDA076187 Mylan Institutional Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51079-443_8b1c22cb-18f7-4c42-b7bb-e5947768c3ba 51079-443 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20070205 ANDA ANDA076187 Mylan Institutional Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51079-444_8b1c22cb-18f7-4c42-b7bb-e5947768c3ba 51079-444 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20070226 ANDA ANDA076187 Mylan Institutional Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51079-445_8b1c22cb-18f7-4c42-b7bb-e5947768c3ba 51079-445 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20070226 ANDA ANDA076187 Mylan Institutional Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51079-446_4bb201e7-661f-4e39-97eb-09001b44b3bf 51079-446 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20071226 ANDA ANDA077122 Mylan Institutional Inc. DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 51079-450_bcc6071f-383c-4011-81a2-a15f696b9533 51079-450 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20130314 ANDA ANDA076418 Mylan Institutional Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 51079-451_bcc6071f-383c-4011-81a2-a15f696b9533 51079-451 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20130314 ANDA ANDA076418 Mylan Institutional Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 51079-452_bcc6071f-383c-4011-81a2-a15f696b9533 51079-452 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20130314 ANDA ANDA076418 Mylan Institutional Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 51079-453_a08fb147-4fbe-4d42-872e-ae08d68388eb 51079-453 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20060911 ANDA ANDA076577 Mylan Institutional Inc. MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 51079-454_04268ee4-c628-4d9a-97d5-01441dc00425 51079-454 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130404 ANDA ANDA076052 Mylan Institutional Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51079-455_04268ee4-c628-4d9a-97d5-01441dc00425 51079-455 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130404 ANDA ANDA076052 Mylan Institutional Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51079-456_04268ee4-c628-4d9a-97d5-01441dc00425 51079-456 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130404 ANDA ANDA076052 Mylan Institutional Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51079-457_21c6d9d9-c335-40bd-a553-3795f0cbed95 51079-457 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20060801 ANDA ANDA077923 Mylan Institutional Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51079-458_428afd0b-b6c1-4753-813b-1c439a7fdd83 51079-458 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20120912 ANDA ANDA076056 Mylan Institutional Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51079-459_21c6d9d9-c335-40bd-a553-3795f0cbed95 51079-459 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20060801 ANDA ANDA077923 Mylan Institutional Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51079-460_7b01f149-3935-4a8a-87c4-3face5c969e1 51079-460 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20120919 ANDA ANDA076288 Mylan Institutional Inc. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 51079-461_7b01f149-3935-4a8a-87c4-3face5c969e1 51079-461 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20120919 ANDA ANDA076288 Mylan Institutional Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 51079-462_7b01f149-3935-4a8a-87c4-3face5c969e1 51079-462 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20120919 ANDA ANDA072688 Mylan Institutional Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 51079-463_7b01f149-3935-4a8a-87c4-3face5c969e1 51079-463 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20120919 ANDA ANDA072688 Mylan Institutional Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 51079-464_7b01f149-3935-4a8a-87c4-3face5c969e1 51079-464 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20120919 ANDA ANDA072688 Mylan Institutional Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 51079-465_7b01f149-3935-4a8a-87c4-3face5c969e1 51079-465 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20120919 ANDA ANDA072688 Mylan Institutional Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 51079-466_954e1fc5-d986-41f3-8f7f-dd8430f5ca77 51079-466 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 20100604 ANDA ANDA075281 Mylan Institutional Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51079-467_597216e9-45c4-4a2d-adad-7a06cbd30f4c 51079-467 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080501 ANDA ANDA078855 Mylan Institutional Inc. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 51079-468_597216e9-45c4-4a2d-adad-7a06cbd30f4c 51079-468 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080501 ANDA ANDA078855 Mylan Institutional Inc. FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 51079-474_50bd09ee-3c0c-4153-9fb3-d2dd13cf9997 51079-474 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20121011 ANDA ANDA090062 Mylan Institutional Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 51079-475_50bd09ee-3c0c-4153-9fb3-d2dd13cf9997 51079-475 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20121011 ANDA ANDA090062 Mylan Institutional Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 51079-480_c605a13f-4424-4ee0-978e-e2f999e530b2 51079-480 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20120921 ANDA ANDA077166 Mylan Institutional Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51079-481_a2d83db3-daf7-47ce-8cd0-38d1d419fc0f 51079-481 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride amantadine hydrochloride CAPSULE, GELATIN COATED ORAL 20120809 ANDA ANDA070589 Mylan Institutional Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 51079-482_c605a13f-4424-4ee0-978e-e2f999e530b2 51079-482 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20120921 ANDA ANDA077166 Mylan Institutional Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51079-485_23cc0b73-83bb-42d6-919c-35514e8063c2 51079-485 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride fluphenazine hydrochloride TABLET, FILM COATED ORAL 19980430 ANDA ANDA089804 Mylan Institutional Inc. FLUPHENAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-486_23cc0b73-83bb-42d6-919c-35514e8063c2 51079-486 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride fluphenazine hydrochloride TABLET, FILM COATED ORAL 19980602 ANDA ANDA089804 Mylan Institutional Inc. FLUPHENAZINE HYDROCHLORIDE 2.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-487_23cc0b73-83bb-42d6-919c-35514e8063c2 51079-487 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride fluphenazine hydrochloride TABLET, FILM COATED ORAL 19980604 ANDA ANDA089804 Mylan Institutional Inc. FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-488_23cc0b73-83bb-42d6-919c-35514e8063c2 51079-488 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride fluphenazine hydrochloride TABLET, FILM COATED ORAL 19980715 ANDA ANDA089804 Mylan Institutional Inc. FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-498_ec2e9563-2cbe-4e14-a65c-0af87d893399 51079-498 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20090302 ANDA ANDA077420 Mylan Institutional Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 51079-499_ec2e9563-2cbe-4e14-a65c-0af87d893399 51079-499 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20090302 ANDA ANDA077420 Mylan Institutional Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 51079-508_d7fbf301-0b08-4b19-bfa0-e0c0067cb5ab 51079-508 HUMAN PRESCRIPTION DRUG Mycophenolic Acid mycophenilic acid TABLET, DELAYED RELEASE ORAL 20140211 ANDA ANDA091248 Mylan Institutional Inc. MYCOPHENOLIC ACID 180 mg/1 Antimetabolite Immunosuppressant [EPC] 51079-509_d7fbf301-0b08-4b19-bfa0-e0c0067cb5ab 51079-509 HUMAN PRESCRIPTION DRUG Mycophenolic Acid mycophenilic acid TABLET, DELAYED RELEASE ORAL 20140211 ANDA ANDA091248 Mylan Institutional Inc. MYCOPHENOLIC ACID 360 mg/1 Antimetabolite Immunosuppressant [EPC] 51079-510_16145a4c-a3d0-404b-bd58-3f220a45ef73 51079-510 HUMAN PRESCRIPTION DRUG Capecitabine capecitabine TABLET, FILM COATED ORAL 20140823 ANDA ANDA090943 Mylan Institutional Inc. CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 51079-513_4b2ba1fe-5355-4d15-9f07-c3e6fec7181a 51079-513 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120907 ANDA ANDA076801 Mylan Institutional Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 51079-514_4b2ba1fe-5355-4d15-9f07-c3e6fec7181a 51079-514 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120907 ANDA ANDA076801 Mylan Institutional Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 51079-515_4b2ba1fe-5355-4d15-9f07-c3e6fec7181a 51079-515 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120907 ANDA ANDA076801 Mylan Institutional Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 51079-516_b49ba844-f140-4b42-b63b-f4d085943693 51079-516 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20130408 ANDA ANDA084114 Mylan Institutional Inc. CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-517_b49ba844-f140-4b42-b63b-f4d085943693 51079-517 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20130408 ANDA ANDA084115 Mylan Institutional Inc. CHLORPROMAZINE HYDROCHLORIDE 200 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-518_b49ba844-f140-4b42-b63b-f4d085943693 51079-518 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20130408 ANDA ANDA083386 Mylan Institutional Inc. CHLORPROMAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-519_b49ba844-f140-4b42-b63b-f4d085943693 51079-519 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20130408 ANDA ANDA084112 Mylan Institutional Inc. CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-520_fa04f22d-1e41-423d-9cac-1c662c240fd4 51079-520 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20071022 ANDA ANDA077578 Mylan Institutional Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 51079-524_ccdbf3e1-5c29-4249-9a03-1f15b70dc04e 51079-524 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron TABLET, FILM COATED ORAL 20121205 ANDA ANDA076930 Mylan Institutional Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 51079-525_ccdbf3e1-5c29-4249-9a03-1f15b70dc04e 51079-525 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron TABLET, FILM COATED ORAL 20121205 ANDA ANDA076930 Mylan Institutional Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 51079-527_fea5aa65-b24a-4dc2-9301-873979a91bfd 51079-527 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19970206 ANDA ANDA070082 Mylan Institutional Inc. FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 51079-538_796d29b5-20a1-4c31-b5c8-f22b29e8e641 51079-538 HUMAN OTC DRUG Loratadine loratadine TABLET ORAL 20120606 ANDA ANDA075790 Mylan Institutional Inc. LORATADINE 10 mg/1 51079-539_7ab4bdd1-84b0-44fc-92bf-0a48a16fca12 51079-539 HUMAN PRESCRIPTION DRUG Repaglinide repaglinide TABLET ORAL 20140227 ANDA ANDA090252 Mylan Institutional Inc. REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 51079-541_d259483d-f21a-4dc6-b504-32a0cc95b3e0 51079-541 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 19970415 ANDA ANDA040185 Mylan Institutional Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-542_d259483d-f21a-4dc6-b504-32a0cc95b3e0 51079-542 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine mealeate TABLET, FILM COATED ORAL 19970415 ANDA ANDA040185 Mylan Institutional Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-543_ffc70230-992c-455c-a55a-d3e322b43720 51079-543 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20120229 NDA NDA021323 Mylan Institutional Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51079-544_ffc70230-992c-455c-a55a-d3e322b43720 51079-544 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20120229 NDA NDA021323 Mylan Institutional Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51079-547_908798f3-5399-4d44-98b3-420fabfe618e 51079-547 HUMAN OTC DRUG Fexofenadine Hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20111007 ANDA ANDA077081 Mylan Institutional Inc. FEXOFENADINE HYDROCHLORIDE 60 mg/1 51079-548_908798f3-5399-4d44-98b3-420fabfe618e 51079-548 HUMAN OTC DRUG Fexofenadine Hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20111007 ANDA ANDA077081 Mylan Institutional Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 51079-550_98109bfb-73ca-4f3c-81f7-393e4b666077 51079-550 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir OINTMENT TOPICAL 20131127 ANDA ANDA202459 Mylan Institutional Inc. ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 51079-555_7ab4bdd1-84b0-44fc-92bf-0a48a16fca12 51079-555 HUMAN PRESCRIPTION DRUG Repaglinide repaglinide TABLET ORAL 20140224 ANDA ANDA090252 Mylan Institutional Inc. REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 51079-557_6f65fa51-6161-4336-9eca-a97c28d09058 51079-557 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA077665 Mylan Institutional Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 51079-558_6f65fa51-6161-4336-9eca-a97c28d09058 51079-558 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA077665 Mylan Institutional Inc. CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 51079-561_f0b7154a-fb02-46c3-a6e5-0e33ff5e2333 51079-561 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20121212 ANDA ANDA076594 Mylan Institutional Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 51079-562_f0b7154a-fb02-46c3-a6e5-0e33ff5e2333 51079-562 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20121212 ANDA ANDA076594 Mylan Institutional Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 51079-563_888b29b1-48d0-4c4e-b0ac-506ea65020e1 51079-563 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 20130313 ANDA ANDA086009 Mylan Institutional Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 51079-565_cd9ebdc9-3917-41ef-bcc6-f2c151009849 51079-565 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 20120105 ANDA ANDA088004 Mylan Institutional Inc. THIORIDAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-566_cd9ebdc9-3917-41ef-bcc6-f2c151009849 51079-566 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 20120105 ANDA ANDA088004 Mylan Institutional Inc. THIORIDAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-567_cd9ebdc9-3917-41ef-bcc6-f2c151009849 51079-567 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 20120105 ANDA ANDA088004 Mylan Institutional Inc. THIORIDAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-572_c2726aa2-1e06-4dad-94d3-16cc35390960 51079-572 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 20120105 ANDA ANDA040209 Mylan Institutional Inc. TRIFLUOPERAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-573_c2726aa2-1e06-4dad-94d3-16cc35390960 51079-573 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 20120105 ANDA ANDA040209 Mylan Institutional Inc. TRIFLUOPERAZINE HYDROCHLORIDE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-574_c2726aa2-1e06-4dad-94d3-16cc35390960 51079-574 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 20120105 ANDA ANDA040209 Mylan Institutional Inc. TRIFLUOPERAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-575_c2726aa2-1e06-4dad-94d3-16cc35390960 51079-575 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 20120105 ANDA ANDA040209 Mylan Institutional Inc. TRIFLUOPERAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-580_cd9ebdc9-3917-41ef-bcc6-f2c151009849 51079-580 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 20120105 ANDA ANDA088004 Mylan Institutional Inc. THIORIDAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-581_7b5fc0e0-0b9a-455d-b93c-746343a74557 51079-581 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19960226 ANDA ANDA071198 Mylan Institutional Inc. LEUCOVORIN CALCIUM 5 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 51079-582_7b5fc0e0-0b9a-455d-b93c-746343a74557 51079-582 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19970827 ANDA ANDA071199 Mylan Institutional Inc. LEUCOVORIN CALCIUM 25 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 51079-584_88154692-703c-4d78-b211-f3f76744becf 51079-584 HUMAN PRESCRIPTION DRUG Nitrofurantoin (macrocrystals) nitrofurantoin (macrocrystals) CAPSULE ORAL 20060915 ANDA ANDA074967 Mylan Institutional Inc. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 51079-585_88154692-703c-4d78-b211-f3f76744becf 51079-585 HUMAN PRESCRIPTION DRUG Nitrofurantoin (macrocrystals) nitrofurantoin (macrocrystals) CAPSULE ORAL 20060915 ANDA ANDA077025 Mylan Institutional Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 51079-587_5c6678d2-c56b-4d76-82fa-2cd2284ff30f 51079-587 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 20121205 ANDA ANDA071093 Mylan Institutional Inc. THIOTHIXENE 2 mg/1 Typical Antipsychotic [EPC] 51079-588_5c6678d2-c56b-4d76-82fa-2cd2284ff30f 51079-588 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 20121205 ANDA ANDA071093 Mylan Institutional Inc. THIOTHIXENE 5 mg/1 Typical Antipsychotic [EPC] 51079-589_5c6678d2-c56b-4d76-82fa-2cd2284ff30f 51079-589 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 20121205 ANDA ANDA071093 Mylan Institutional Inc. THIOTHIXENE 10 mg/1 Typical Antipsychotic [EPC] 51079-597_e8a93f1a-3883-487e-a0b3-b92a5a496470 51079-597 HUMAN OTC DRUG Cetirizine Hydrochloride cetirizine hydrochloride TABLET, FILM COATED ORAL 20120330 ANDA ANDA076677 Mylan Institutional Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 51079-598_2cd59c3d-4222-4df7-b576-262e6e567ce6 51079-598 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20000501 ANDA ANDA063029 Mylan Institutional Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 51079-599_5fc50ed4-7ad8-4b0c-8110-9f43b7cb80fd 51079-599 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20130610 ANDA ANDA202856 Mylan Institutional Inc. FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 51079-608_5fc50ed4-7ad8-4b0c-8110-9f43b7cb80fd 51079-608 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20130610 ANDA ANDA202856 Mylan Institutional Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 51079-620_4a0b69ca-0539-4e36-9cdc-3caa663795c5 51079-620 HUMAN PRESCRIPTION DRUG Azathioprine azathioprine TABLET ORAL 20100723 ANDA ANDA075568 Mylan Institutional Inc. AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 51079-621_637dc576-f528-4b68-bd43-58bbf7352bf2 51079-621 HUMAN PRESCRIPTION DRUG Granulex trypsin, balsam peru and castor oil SPRAY TOPICAL 19670301 UNAPPROVED DRUG OTHER Mylan Institutional Inc. BALSAM PERU; CASTOR OIL; TRYPSIN 87; 788; .12 mg/g; mg/g; mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 51079-622_7c00f98a-4722-4917-8680-7b84da55f555 51079-622 HUMAN OTC DRUG Proderm castor oil and balsam peru SPRAY TOPICAL 20120926 UNAPPROVED DRUG OTHER Mylan Institutional Inc. BALSAM PERU; CASTOR OIL 87; 788 mg/g; mg/g 51079-623_31dd2d9c-b965-4bc3-9ab9-afdf4112fd48 51079-623 HUMAN PRESCRIPTION DRUG Sulfamylon Mafenide Acetate CREAM TOPICAL 20061208 NDA NDA016763 Mylan Institutional Inc. MAFENIDE ACETATE 85 mg/g Methylated Sulfonamide Antibacterial [EPC],Methylated Sulfonamides [Chemical/Ingredient] 51079-624_f7a40218-698c-48ee-924f-9b566c615d33 51079-624 HUMAN PRESCRIPTION DRUG Sulfamylon mafenide acetate POWDER, FOR SOLUTION TOPICAL 19980605 NDA NDA019832 Mylan Institutional Inc. MAFENIDE ACETATE 50 g/1 Methylated Sulfonamide Antibacterial [EPC],Methylated Sulfonamides [Chemical/Ingredient] 51079-629_cafb55ed-f2fb-4462-8b5c-c0e34cd83cbc 51079-629 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20110823 ANDA ANDA072801 UDL Laboratories, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 51079-630_f9ae72e4-b209-44ca-876b-4787a2d16b74 51079-630 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 19981005 ANDA ANDA072575 Mylan Institutional Inc. PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 51079-631_f9ae72e4-b209-44ca-876b-4787a2d16b74 51079-631 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 19981006 ANDA ANDA072575 Mylan Institutional Inc. PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 51079-632_f9ae72e4-b209-44ca-876b-4787a2d16b74 51079-632 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 19981006 ANDA ANDA072575 Mylan Institutional Inc. PRAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 51079-644_15e06932-06cc-4c53-81ed-a0457f1168f7 51079-644 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 19970825 ANDA ANDA073144 Mylan Institutional Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 51079-651_7b10def3-8980-4d60-8545-d1afb70e52f0 51079-651 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19981001 ANDA ANDA070791 Mylan Institutional Inc. DOXEPIN HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 51079-657_2e7c1e97-b8b2-44c0-aeac-18f9142a522b 51079-657 HUMAN PRESCRIPTION DRUG Albuterol albuterol TABLET ORAL 20110812 ANDA ANDA072894 UDL Laboratories, Inc. ALBUTEROL SULFATE 2 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 51079-658_2e7c1e97-b8b2-44c0-aeac-18f9142a522b 51079-658 HUMAN PRESCRIPTION DRUG Albuterol albuterol TABLET ORAL 20110812 ANDA ANDA072894 UDL Laboratories, Inc. ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 51079-667_7b16d772-ef1f-4f41-a0d4-47e3e38024e1 51079-667 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20110318 ANDA ANDA073039 UDL Laboratories, Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51079-670_ea86966f-43ce-436c-897f-bc22b21a9dc8 51079-670 HUMAN PRESCRIPTION DRUG Methotrexate methotrexate TABLET ORAL 20130110 ANDA ANDA081235 Mylan Institutional Inc. METHOTREXATE 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 51079-684_69a36623-dcbc-46c1-a7d4-40d901aa2f13 51079-684 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 19970724 ANDA ANDA073457 Mylan Institutional Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51079-685_69a36623-dcbc-46c1-a7d4-40d901aa2f13 51079-685 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 19970723 ANDA ANDA073457 Mylan Institutional Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51079-690_39b824db-8d7e-49dc-b3be-0dcbb6ff4b74 51079-690 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 19971001 ANDA ANDA072741 Mylan Institutional Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 51079-692_aca53fc1-506d-4a12-b74b-3f1c7362199c 51079-692 HUMAN PRESCRIPTION DRUG Bicalutamide bicalutamide TABLET, FILM COATED ORAL 20091030 ANDA ANDA079185 UDL Laboratories, Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 51079-697_3cd02107-532a-4535-a262-85e81012e2b5 51079-697 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20100607 ANDA ANDA076113 UDL Laboratories, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51079-698_3cd02107-532a-4535-a262-85e81012e2b5 51079-698 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20100608 ANDA ANDA076113 UDL Laboratories, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51079-699_3cd02107-532a-4535-a262-85e81012e2b5 51079-699 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20100607 ANDA ANDA076113 UDL Laboratories, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51079-700_17babdce-9f90-4621-8786-e9f4a4d9d4e0 51079-700 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20100614 ANDA ANDA040821 Mylan Institutional Inc. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 51079-721_6882a448-442a-4286-84dd-ebeade6528f6 51079-721 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil mycophenolate mofetil CAPSULE ORAL 20090601 ANDA ANDA065520 Mylan Institutional Inc. MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 51079-722_4b5e6c54-c94e-4c40-8169-e8e260ea5906 51079-722 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20061127 ANDA ANDA076702 Mylan Institutional Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 51079-723_4b5e6c54-c94e-4c40-8169-e8e260ea5906 51079-723 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20061127 ANDA ANDA076644 Mylan Institutional Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 51079-724_86c38651-918f-4cb4-bf46-b881940d3398 51079-724 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20120109 ANDA ANDA076578 Mylan Institutional Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 51079-725_86c38651-918f-4cb4-bf46-b881940d3398 51079-725 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20120109 ANDA ANDA076578 Mylan Institutional Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 51079-726_94f90bb0-ed7f-44da-99fc-29fb1c24327f 51079-726 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20120105 ANDA ANDA076314 Mylan Institutional Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51079-727_94f90bb0-ed7f-44da-99fc-29fb1c24327f 51079-727 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20120105 ANDA ANDA076314 Mylan Institutional Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51079-728_94f90bb0-ed7f-44da-99fc-29fb1c24327f 51079-728 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20120105 ANDA ANDA076314 Mylan Institutional Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51079-733_5a7392d3-dcf6-4af2-9af9-687ec13c45a7 51079-733 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20120925 ANDA ANDA070278 Mylan Institutional Inc. HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] 51079-734_5a7392d3-dcf6-4af2-9af9-687ec13c45a7 51079-734 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20120925 ANDA ANDA070278 Mylan Institutional Inc. HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] 51079-735_5a7392d3-dcf6-4af2-9af9-687ec13c45a7 51079-735 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20120925 ANDA ANDA070278 Mylan Institutional Inc. HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] 51079-736_5a7392d3-dcf6-4af2-9af9-687ec13c45a7 51079-736 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20120925 ANDA ANDA070278 Mylan Institutional Inc. HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 51079-745_b7af4644-1654-4e86-9d09-48f8039bb71f 51079-745 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19960307 ANDA ANDA072838 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 51079-746_b7af4644-1654-4e86-9d09-48f8039bb71f 51079-746 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19960307 ANDA ANDA072838 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 51079-747_b7af4644-1654-4e86-9d09-48f8039bb71f 51079-747 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19960307 ANDA ANDA072838 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 51079-749_5e96116e-7971-45fe-a017-0592eceef60e 51079-749 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 20100706 ANDA ANDA075417 Mylan Institutional Inc. CLOZAPINE 200 mg/1 Atypical Antipsychotic [EPC] 51079-753_989ca8a8-3ad6-4ee4-aa9c-eed731828753 51079-753 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20130924 ANDA ANDA070848 Mylan Institutional Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 51079-759_69a36623-dcbc-46c1-a7d4-40d901aa2f13 51079-759 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 19990616 ANDA ANDA073457 Mylan Institutional Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51079-762_818f362f-b666-4bb5-9d77-c76c74ab3ee7 51079-762 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20120629 ANDA ANDA076671 Mylan Institutional Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51079-763_818f362f-b666-4bb5-9d77-c76c74ab3ee7 51079-763 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20120629 ANDA ANDA076671 Mylan Institutional Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51079-764_818f362f-b666-4bb5-9d77-c76c74ab3ee7 51079-764 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20120629 ANDA ANDA076671 Mylan Institutional Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51079-765_24552cf7-b191-4553-ad0a-3ebd211d2d16 51079-765 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium CAPSULE ORAL 20120724 ANDA ANDA090407 Mylan Institutional Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 51079-766_599810f9-15ae-4aac-bb7a-1d4dcaebf928 51079-766 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090203 ANDA ANDA077567 Mylan Institutional Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 51079-767_599810f9-15ae-4aac-bb7a-1d4dcaebf928 51079-767 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090203 ANDA ANDA077567 Mylan Institutional Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 51079-768_e8c1187d-8d84-4550-ace7-782138732ab1 51079-768 HUMAN PRESCRIPTION DRUG Zonisamide zonisamide CAPSULE ORAL 20120810 ANDA ANDA077637 Mylan Institutional Inc. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51079-771_2545242a-f333-4bb4-a54d-8c0e5b9a753f 51079-771 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20121227 ANDA ANDA077316 Mylan Institutional Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 51079-774_c09ae17a-f3b6-4f6b-b31a-25fa1ab47bc2 51079-774 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20120907 ANDA ANDA078902 Mylan Institutional Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51079-776_c5450bda-3388-4e66-9d2a-e46ab60c3101 51079-776 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20051101 ANDA ANDA075640 Mylan Institutional Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51079-777_102b9a8a-01d5-44f8-a57b-9e159aa508d7 51079-777 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20070910 ANDA ANDA040655 Mylan Institutional Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 51079-778_102b9a8a-01d5-44f8-a57b-9e159aa508d7 51079-778 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20070910 ANDA ANDA040656 Mylan Institutional Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 51079-779_102b9a8a-01d5-44f8-a57b-9e159aa508d7 51079-779 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20070910 ANDA ANDA040355 Mylan Institutional Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 51079-782_428afd0b-b6c1-4753-813b-1c439a7fdd83 51079-782 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20120912 ANDA ANDA076056 Mylan Institutional Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51079-787_34620a46-49ba-4593-960e-a8ec41721a20 51079-787 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20110823 ANDA ANDA074256 UDL Laboratories, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 51079-788_ab170c48-d25b-405a-a8d9-56c75d2bf9bb 51079-788 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20120814 ANDA ANDA074215 Mylan Institutional Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-789_ab170c48-d25b-405a-a8d9-56c75d2bf9bb 51079-789 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20120814 ANDA ANDA074215 Mylan Institutional Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-790_ab170c48-d25b-405a-a8d9-56c75d2bf9bb 51079-790 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20120814 ANDA ANDA074215 Mylan Institutional Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-796_19cb4c11-1bd5-471d-8f2f-902e4f5fbac0 51079-796 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20100813 ANDA ANDA091176 Mylan Institutional Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 51079-801_b45e90f7-8725-45ca-9492-786c30f57048 51079-801 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20120831 ANDA ANDA076704 Mylan Institutional Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51079-802_b45e90f7-8725-45ca-9492-786c30f57048 51079-802 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20120831 ANDA ANDA076704 Mylan Institutional Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51079-806_19cb4c11-1bd5-471d-8f2f-902e4f5fbac0 51079-806 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20100813 ANDA ANDA091176 Mylan Institutional Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 51079-810_21ad9c90-1552-4e8e-b4a6-4694e02b70e7 51079-810 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 19940712 ANDA ANDA074226 Mylan Institutional Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 51079-811_21ad9c90-1552-4e8e-b4a6-4694e02b70e7 51079-811 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 19940712 ANDA ANDA074226 Mylan Institutional Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 51079-812_39a359c7-5d5f-4ef1-b83c-6343e6b5f5d3 51079-812 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 19940712 ANDA ANDA074172 Mylan Institutional Inc. NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51079-813_39a359c7-5d5f-4ef1-b83c-6343e6b5f5d3 51079-813 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 19940712 ANDA ANDA074172 Mylan Institutional Inc. NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51079-816_19cb4c11-1bd5-471d-8f2f-902e4f5fbac0 51079-816 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20100813 ANDA ANDA091176 Mylan Institutional Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 51079-817_5f742224-618e-4f4c-bdec-7693be99c697 51079-817 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20101104 ANDA ANDA090596 UDL Laboratories, Inc. TACROLIMUS .5 mg/1 51079-818_5f742224-618e-4f4c-bdec-7693be99c697 51079-818 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20101104 ANDA ANDA090596 UDL Laboratories, Inc. TACROLIMUS 1 mg/1 51079-819_c966bd19-2de0-488a-8844-ad0961898917 51079-819 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20120608 ANDA ANDA040245 Mylan Institutional Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 51079-820_12c7a21f-48c5-473c-92c8-9986b76f23d2 51079-820 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20081104 ANDA ANDA076919 Mylan Institutional Inc. LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51079-821_12c7a21f-48c5-473c-92c8-9986b76f23d2 51079-821 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20081104 ANDA ANDA076919 Mylan Institutional Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51079-822_12c7a21f-48c5-473c-92c8-9986b76f23d2 51079-822 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20081104 ANDA ANDA076919 Mylan Institutional Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51079-824_a7fa9d04-fa59-4e57-afdf-f3182f3bbbcc 51079-824 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120912 ANDA ANDA077873 Mylan Institutional Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51079-825_a7fa9d04-fa59-4e57-afdf-f3182f3bbbcc 51079-825 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120912 ANDA ANDA077873 Mylan Institutional Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51079-852_c79a3cd6-ae40-46ba-9280-17583c7f8531 51079-852 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20120831 ANDA ANDA077590 Mylan Institutional Inc. GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 51079-853_c79a3cd6-ae40-46ba-9280-17583c7f8531 51079-853 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20120831 ANDA ANDA077590 Mylan Institutional Inc. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 51079-854_c79a3cd6-ae40-46ba-9280-17583c7f8531 51079-854 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20120831 ANDA ANDA077590 Mylan Institutional Inc. GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 51079-860_12c7a21f-48c5-473c-92c8-9986b76f23d2 51079-860 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20100324 ANDA ANDA090261 Mylan Institutional Inc. LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51079-863_d913fbce-be75-4f14-aa40-d12d1392ccf6 51079-863 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 19960214 ANDA ANDA074434 Mylan Institutional Inc. CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51079-864_d913fbce-be75-4f14-aa40-d12d1392ccf6 51079-864 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 19960214 ANDA ANDA074434 Mylan Institutional Inc. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51079-865_ec2e9563-2cbe-4e14-a65c-0af87d893399 51079-865 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20090619 ANDA ANDA077420 Mylan Institutional Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 51079-866_ec2e9563-2cbe-4e14-a65c-0af87d893399 51079-866 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20090619 ANDA ANDA077420 Mylan Institutional Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 51079-868_f9a3b5ce-bd2b-444d-92d8-aeaebf59ea5a 51079-868 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 19960501 ANDA ANDA074461 Mylan Institutional Inc. INDAPAMIDE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 51079-869_042d45fd-cc7e-49bf-a573-af0fcd341a62 51079-869 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120712 ANDA ANDA074587 Mylan Institutional Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 51079-870_769f2d6e-21be-4563-9990-a60d13b7e0b2 51079-870 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, CHEWABLE ORAL 19960515 ANDA ANDA073524 Mylan Institutional Inc. CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 51079-871_1e03f716-32c8-4173-99d8-ae8826d9d043 51079-871 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20110527 ANDA ANDA070848 UDL Laboratories, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 51079-872_5e9c9f88-e0e4-4cc5-805d-94f2a19f8fd9 51079-872 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19960730 ANDA ANDA074388 Mylan Institutional Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 51079-873_5e9c9f88-e0e4-4cc5-805d-94f2a19f8fd9 51079-873 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19960730 ANDA ANDA074388 Mylan Institutional Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 51079-879_e0115f82-c45b-40aa-9685-5540f8e44d57 51079-879 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20120925 ANDA ANDA074467 Mylan Institutional Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 51079-881_42ce4818-3300-48e4-a11d-ca810dcd2ce2 51079-881 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 19970715 ANDA ANDA075150 Mylan Institutional Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-882_42ce4818-3300-48e4-a11d-ca810dcd2ce2 51079-882 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 19970715 ANDA ANDA075150 Mylan Institutional Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-883_42ce4818-3300-48e4-a11d-ca810dcd2ce2 51079-883 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 19970715 ANDA ANDA075150 Mylan Institutional Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51079-884_6a7f9716-799a-437c-ba63-7e156f9a7b43 51079-884 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET ORAL 20100127 ANDA ANDA090324 Mylan Institutional Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 51079-886_447dbb34-7903-4e6a-be31-48a0b0e0d2f5 51079-886 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20131230 ANDA ANDA072801 Mylan Institutional Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 51079-888_447dbb34-7903-4e6a-be31-48a0b0e0d2f5 51079-888 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20140102 ANDA ANDA070184 Mylan Institutional Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 51079-889_6b9a9221-bddb-41f6-9f25-afa77d22f00d 51079-889 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 19980115 ANDA ANDA074425 Mylan Institutional Inc. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 51079-890_3c9644a2-c912-4c7e-a490-031cd4b6a1a4 51079-890 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20121205 ANDA ANDA064150 Mylan Institutional Inc. RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 51079-891_44575a2e-d127-4fb8-9f29-374d9a7b7308 51079-891 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20130218 ANDA ANDA074700 Mylan Institutional Inc. BUMETANIDE .5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 51079-892_44575a2e-d127-4fb8-9f29-374d9a7b7308 51079-892 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20130218 ANDA ANDA074700 Mylan Institutional Inc. BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 51079-893_44575a2e-d127-4fb8-9f29-374d9a7b7308 51079-893 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20130218 ANDA ANDA074700 Mylan Institutional Inc. BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 51079-894_042d45fd-cc7e-49bf-a573-af0fcd341a62 51079-894 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120712 ANDA ANDA074587 Mylan Institutional Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 51079-895_50692fb9-2fde-4808-a8de-f1464a2896d8 51079-895 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20120815 ANDA ANDA040596 Mylan Institutional Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51079-896_09f0f7a8-afef-4191-922d-df9922862967 51079-896 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101001 ANDA ANDA090649 Mylan Institutional Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 51079-897_09f0f7a8-afef-4191-922d-df9922862967 51079-897 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100820 ANDA ANDA090649 Mylan Institutional Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 51079-899_042d45fd-cc7e-49bf-a573-af0fcd341a62 51079-899 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120712 ANDA ANDA074587 Mylan Institutional Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 51079-901_ff21785b-d104-4f42-a1a1-4ac853b08242 51079-901 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20041215 ANDA ANDA076762 Mylan Institutional Inc. LOXAPINE SUCCINATE 10 mg/1 51079-902_ff21785b-d104-4f42-a1a1-4ac853b08242 51079-902 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20041215 ANDA ANDA076762 Mylan Institutional Inc. LOXAPINE SUCCINATE 25 mg/1 51079-903_ff21785b-d104-4f42-a1a1-4ac853b08242 51079-903 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20041215 ANDA ANDA076762 Mylan Institutional Inc. LOXAPINE SUCCINATE 50 mg/1 51079-905_7c0a2e81-f41a-49b2-879e-49a9b2331d35 51079-905 HUMAN PRESCRIPTION DRUG Phenytoin Sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20120912 ANDA ANDA040298 Mylan Institutional Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51079-906_e7d91157-4c87-4073-b802-87e697020b0e 51079-906 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20070820 ANDA ANDA074739 Mylan Institutional Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 51079-917_3ea9bd46-dc21-4a9b-ad7b-18ed96617681 51079-917 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120109 ANDA ANDA075138 Mylan Institutional Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 51079-921_5e96116e-7971-45fe-a017-0592eceef60e 51079-921 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 19991115 ANDA ANDA075417 Mylan Institutional Inc. CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] 51079-922_5e96116e-7971-45fe-a017-0592eceef60e 51079-922 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 19991115 ANDA ANDA075417 Mylan Institutional Inc. CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] 51079-923_a70933fc-9263-4392-8eaa-53ac9e230e50 51079-923 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, EXTENDED RELEASE ORAL 19991201 ANDA ANDA075091 Mylan Institutional Inc. CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 51079-924_77f38b7c-27f4-441c-9c01-cd36848e6a12 51079-924 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991215 ANDA ANDA074910 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 51079-925_77f38b7c-27f4-441c-9c01-cd36848e6a12 51079-925 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991215 ANDA ANDA074910 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 51079-926_77f38b7c-27f4-441c-9c01-cd36848e6a12 51079-926 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991215 ANDA ANDA074910 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 51079-928_4b11b22d-f811-452b-a4bb-1e7c8accc394 51079-928 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20000115 ANDA ANDA075113 Mylan Institutional Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51079-929_4b11b22d-f811-452b-a4bb-1e7c8accc394 51079-929 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20000115 ANDA ANDA075113 Mylan Institutional Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51079-930_2545242a-f333-4bb4-a54d-8c0e5b9a753f 51079-930 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20121227 ANDA ANDA077316 Mylan Institutional Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 51079-931_2545242a-f333-4bb4-a54d-8c0e5b9a753f 51079-931 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20121227 ANDA ANDA077316 Mylan Institutional Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 51079-932_2545242a-f333-4bb4-a54d-8c0e5b9a753f 51079-932 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20121227 ANDA ANDA077316 Mylan Institutional Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 51079-935_2ebee624-71ee-4ebb-8bad-555f8d0dbac2 51079-935 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Capsules Triamterene and Hydrochlorothiazide Capsules CAPSULE ORAL 20110520 ANDA ANDA074701 UDL Laboratories, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 51079-936_24a4243f-0855-44c1-bb78-ba6f14b273f9 51079-936 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous Terazosin Hydrochloride Anhydrous CAPSULE ORAL 20110128 ANDA ANDA075140 UDL Laboratories, Inc. TERAZOSIN HYDROCHLORIDE ANHYDROUS 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 51079-937_24a4243f-0855-44c1-bb78-ba6f14b273f9 51079-937 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous Terazosin Hydrochloride Anhydrous CAPSULE ORAL 20110128 ANDA ANDA075140 UDL Laboratories, Inc. TERAZOSIN HYDROCHLORIDE ANHYDROUS 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 51079-938_24a4243f-0855-44c1-bb78-ba6f14b273f9 51079-938 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous Terazosin Hydrochloride Anhydrous CAPSULE ORAL 20110128 ANDA ANDA075140 UDL Laboratories, Inc. TERAZOSIN HYDROCHLORIDE ANHYDROUS 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 51079-941_e526b734-ad8d-473c-a9eb-ff6cce4c6930 51079-941 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20080901 ANDA ANDA076584 Mylan Institutional Inc. ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 51079-942_e526b734-ad8d-473c-a9eb-ff6cce4c6930 51079-942 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20080901 ANDA ANDA076584 Mylan Institutional Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 51079-943_5027be61-c5d7-423d-b3fc-c6e71b06d98e 51079-943 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20000701 ANDA ANDA075491 Mylan Institutional Inc. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 51079-944_5027be61-c5d7-423d-b3fc-c6e71b06d98e 51079-944 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20000701 ANDA ANDA075491 Mylan Institutional Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 51079-947_d795e1b7-4578-49b4-bccd-143be19e9914 51079-947 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20001001 ANDA ANDA075124 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 51079-948_d795e1b7-4578-49b4-bccd-143be19e9914 51079-948 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20001001 ANDA ANDA075124 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 51079-949_d795e1b7-4578-49b4-bccd-143be19e9914 51079-949 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20001001 ANDA ANDA075124 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 51079-950_f8803c00-735a-4306-b7e1-a6990360a012 51079-950 HUMAN PRESCRIPTION DRUG Enalapril Maleate enalapril maleate TABLET ORAL 20001115 ANDA ANDA075480 Mylan Institutional Inc. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 51079-951_f8803c00-735a-4306-b7e1-a6990360a012 51079-951 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20001115 ANDA ANDA075480 Mylan Institutional Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 51079-952_f8803c00-735a-4306-b7e1-a6990360a012 51079-952 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20001115 ANDA ANDA075480 Mylan Institutional Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 51079-953_f8803c00-735a-4306-b7e1-a6990360a012 51079-953 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20001115 ANDA ANDA075480 Mylan Institutional Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 51079-957_6bcf323b-c1d0-4ee5-9e96-74af9a34ce89 51079-957 HUMAN PRESCRIPTION DRUG doxazosin doxazosin mesylate TABLET ORAL 20010101 ANDA ANDA075509 Mylan Institutional Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 51079-958_6bcf323b-c1d0-4ee5-9e96-74af9a34ce89 51079-958 HUMAN PRESCRIPTION DRUG doxazosin doxazosin mesylate TABLET ORAL 20010101 ANDA ANDA075509 Mylan Institutional Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 51079-959_6bcf323b-c1d0-4ee5-9e96-74af9a34ce89 51079-959 HUMAN PRESCRIPTION DRUG doxazosin doxazosin mesylate TABLET ORAL 20010101 ANDA ANDA075509 Mylan Institutional Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 51079-960_86cb8566-6d08-403d-87b7-543525fb784e 51079-960 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20010416 ANDA ANDA076008 Mylan Institutional Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 51079-966_92934dd7-3422-4b56-971a-0428d3f3b7cb 51079-966 HUMAN PRESCRIPTION DRUG Famotidine famotidine TABLET, FILM COATED ORAL 20121212 ANDA ANDA075704 Mylan Institutional Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 51079-974_1e1c679e-74df-4d1d-8949-17ff0d6c1d1b 51079-974 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20121102 ANDA ANDA075451 Mylan Institutional Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51079-975_1e1c679e-74df-4d1d-8949-17ff0d6c1d1b 51079-975 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20121102 ANDA ANDA075451 Mylan Institutional Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51079-976_1e1c679e-74df-4d1d-8949-17ff0d6c1d1b 51079-976 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20121102 ANDA ANDA075451 Mylan Institutional Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51079-978_a70933fc-9263-4392-8eaa-53ac9e230e50 51079-978 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, EXTENDED RELEASE ORAL 20020201 ANDA ANDA075091 Mylan Institutional Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 51079-979_7e1a8152-941a-4aa4-bcb0-83c04905678f 51079-979 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20110204 ANDA ANDA040424 UDL Laboratories, Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 51079-980_7e1a8152-941a-4aa4-bcb0-83c04905678f 51079-980 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20110204 ANDA ANDA040424 UDL Laboratories, Inc. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 51079-981_1aca82d6-31a2-471a-b35a-40c5ace8c14e 51079-981 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20120827 ANDA ANDA076071 Mylan Institutional Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51079-982_1aca82d6-31a2-471a-b35a-40c5ace8c14e 51079-982 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20120827 ANDA ANDA076071 Mylan Institutional Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51079-983_1aca82d6-31a2-471a-b35a-40c5ace8c14e 51079-983 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20120827 ANDA ANDA076071 Mylan Institutional Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51079-984_1aca82d6-31a2-471a-b35a-40c5ace8c14e 51079-984 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20120827 ANDA ANDA076071 Mylan Institutional Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51079-985_86cb8566-6d08-403d-87b7-543525fb784e 51079-985 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20020325 ANDA ANDA076008 Mylan Institutional Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 51079-986_86cb8566-6d08-403d-87b7-543525fb784e 51079-986 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20020325 ANDA ANDA076008 Mylan Institutional Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 51079-991_3159521e-f925-4ced-a3ae-237eb594e0c9 51079-991 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride tramadol hydrochloride TABLET, FILM COATED ORAL 20020801 ANDA ANDA075986 Mylan Institutional Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 51079-992_27d81e6c-9fc4-4364-824d-194c5de2d435 51079-992 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20020915 ANDA ANDA075889 Mylan Institutional Inc. FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51079-993_27d81e6c-9fc4-4364-824d-194c5de2d435 51079-993 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20020915 ANDA ANDA075889 Mylan Institutional Inc. FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51079-994_86cb8566-6d08-403d-87b7-543525fb784e 51079-994 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20021202 ANDA ANDA076008 Mylan Institutional Inc. BUSPIRONE HYDROCHLORIDE 30 mg/1 51079-996_11823208-7e50-410a-9386-2ef2f77f1b8a 51079-996 HUMAN PRESCRIPTION DRUG PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET, FILM COATED ORAL 20030201 ANDA ANDA075998 Mylan Institutional Inc. PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] 51079-998_79a0e9fc-589e-46ef-b9da-7aa3665bf1e2 51079-998 HUMAN PRESCRIPTION DRUG Tizanidine tizanidine TABLET ORAL 20110128 ANDA ANDA076354 UDL Laboratories, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 51087-272_741e3f83-e561-4fbf-8976-00d505304958 51087-272 HUMAN OTC DRUG Antibacterial Hand Sanitizer Pocket Sprayer Alcohol SPRAY TOPICAL 20110203 OTC MONOGRAPH NOT FINAL part333E National Pen Co., LLC ALCOHOL 4.96 mL/8mL 51096-0001_d38ebb18-16b2-484e-b78e-70409e70f7e1 51096-0001 HUMAN OTC DRUG Gluten Sensitivity Formula Lycopodium Clavatum, Pulsatilla CAPSULE ORAL 20130301 UNAPPROVED HOMEOPATHIC The Wise Alternative LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS 12; 12 [hp_X]/mg; [hp_X]/mg 51096-0002_e5de5935-98e9-422e-8345-7a8e60226bfa 51096-0002 HUMAN OTC DRUG Hypothalmu Stim Aralia Quinquefolia, Ginkgo Biloba, Hydrocotyle Asiatica, Brain, Hypothalamus, Pituitary, Phosphorus LIQUID ORAL 20121010 UNAPPROVED HOMEOPATHIC The Wise Alternative AMERICAN GINSENG; CENTELLA ASIATICA; GINKGO; PHOSPHORUS; PORK BRAIN; SILICON DIOXIDE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND 3; 3; 3; 12; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 51096-0003_0b3e3b50-767c-4a9e-b1b6-dfdfb0412f1d 51096-0003 HUMAN OTC DRUG Adren Aid Aralia Quinquefolia, Avena Sativa, Glandula Suprarenalis Suis, Arsenicum Iodatum, Ignatia Amara, Lycopodium Clavatum LIQUID ORAL 20130305 UNAPPROVED HOMEOPATHIC The Wise Alternative AMERICAN GINSENG; ARSENIC TRIIODIDE; AVENA SATIVA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; ZINC 3; 12; 3; 12; 12; 12; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 51096-0004_6810d38e-fbd6-475d-8901-7fa4919872d7 51096-0004 HUMAN OTC DRUG Walnut Walnut LIQUID ORAL 20130913 UNAPPROVED HOMEOPATHIC The Wise Alternative ENGLISH WALNUT 200 [hp_C]/mL 51096-0005_58b47510-2255-4000-854b-fd7ce344ef27 51096-0005 HUMAN PRESCRIPTION DRUG Dr. Wise Special Formula 1 Toa Free Uncaria Tomentosa LIQUID ORAL 20120927 UNAPPROVED HOMEOPATHIC J and L Health LLC dba The Wise Alternative CAT'S CLAW 6 [hp_X]/mL 51096-0006_7f67f6a8-0fbf-443c-9f51-2afa834eb1e7 51096-0006 HUMAN OTC DRUG Anpitua Stim Adrenocorticotrophin, Agnus castus, Baryta carbonica, Calcarea carbonica, Iodium, Lac caninum, Natrum muriaticum, Phosphoricum acidum, Sepia, Thyroidinum suis, LIQUID ORAL 20120926 UNAPPROVED HOMEOPATHIC J and Health DBA Wise Alternative BARIUM CARBONATE; CANIS LUPUS FAMILIARIS MILK; CHASTE TREE; CORTICOTROPIN; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; THYROID, PORCINE 12; 12; 12; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 51096-0007_62d856ca-6a26-4a86-9b9a-f075e3d84e31 51096-0007 HUMAN OTC DRUG Thyro Aid Fucus Vesiculosus, Spongia Tosta, Glandula Suprarenalis Suis, Pituitary, Thyroidinum, Bromium, Calcarea Carbonica LIQUID ORAL 20130318 UNAPPROVED HOMEOPATHIC The Wise Alternative BROMINE; FUCUS VESICULOSUS; IODINE; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID 12; 3; 12; 12; 12; 12; 3; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 51098-742_1d8e5de7-1d23-487a-a5cc-535ac356504d 51098-742 HUMAN OTC DRUG Hands First 4 in 1 Benzalkonium Chloride, Allantoin SOLUTION TOPICAL 20100801 OTC MONOGRAPH FINAL part347 Avadim II LLC ALLANTOIN; BENZALKONIUM CHLORIDE 5; 1.3 g/1000mL; mL/1000mL 51105-001_68ddfe17-995f-46ae-85d1-a6baa445bb80 51105-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19760101 UNAPPROVED MEDICAL GAS Wilson Products Compressed Gas Co. OXYGEN 990 mL/L 51117-001_3953bcab-8db7-4d95-b162-3b0b69a74075 51117-001 HUMAN OTC DRUG Skincare LdeL Retinol Day Broad Spectrum SPF 20 Avobenzone, Homosalate, Oxybenzone, and Octinoxate CREAM TOPICAL 20120905 OTC MONOGRAPH FINAL part352 Beauty Solutions, Ltd. AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYBENZONE 20; 30; 75; 50 mg/g; mg/g; mg/g; mg/g 51121-035_6fcaf2ef-0976-4542-bb44-66f6c16e9568 51121-035 HUMAN OTC DRUG Burnaid Burn Gel Tea Tree Oil GEL TOPICAL 20131104 UNAPPROVED DRUG OTHER Clear Healthcare LLC TEA TREE OIL 10 mg/g 51125-005_a07691ea-5908-4187-b573-0ec58faf19e0 51125-005 HUMAN PRESCRIPTION DRUG Ultramicrosize Griseofulvin Ultramicrosize Griseofulvin Tablets TABLET, COATED ORAL 20140109 ANDA ANDA204371 RiconPharma LLC. GRISEOFULVIN 125 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 51125-006_a07691ea-5908-4187-b573-0ec58faf19e0 51125-006 HUMAN PRESCRIPTION DRUG Ultramicrosize Griseofulvin Ultramicrosize Griseofulvin Tablets TABLET, COATED ORAL 20140109 ANDA ANDA204371 RiconPharma LLC. GRISEOFULVIN 250 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 51130-333_98f9f508-2419-4c45-aee4-4c0974423010 51130-333 HUMAN OTC DRUG CaraDerma benzoyl peroxide CREAM TOPICAL 20100902 OTC MONOGRAPH NOT FINAL part333D A Refreshing Discovery, Inc. BENZOYL PEROXIDE 1.125 g/15g 51134-0062_e5610d61-6b49-48c3-8e0d-127a499e0d79 51134-0062 HUMAN OTC DRUG Redness reliever tetrahydrozoline HCl LIQUID OPHTHALMIC 20100829 OTC MONOGRAPH FINAL part349 Samchundang Pharm. Co., Ltd. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 51134-0064_2424bf7d-411d-457a-8687-e02248c004e5 51134-0064 HUMAN OTC DRUG Advanced relief dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl LIQUID OPHTHALMIC 20100829 OTC MONOGRAPH FINAL part349 Samchundang Pharm. Co., Ltd. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL 51134-5191_010cda0b-f66b-4598-bbb0-fdf67b810afd 51134-5191 HUMAN OTC DRUG Colirio Ocusan Polyethlene glycol 400 Tetrahydrozoline HCl LIQUID OPHTHALMIC 20100801 OTC MONOGRAPH FINAL part352 Samchundang Pharm. Co., Ltd. POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE .15; .0075 mL/15mL; mL/15mL 51138-007_5ebd1b75-510d-4dce-b880-a941d35bba5b 51138-007 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20110101 ANDA ANDA073092 Med Health Pharma, LLC BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 51138-008_5ebd1b75-510d-4dce-b880-a941d35bba5b 51138-008 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20110101 ANDA ANDA073092 Med Health Pharma, LLC BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 51138-017_da91ee9c-13cb-4ca0-b30c-a2686b7b699f 51138-017 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 20110110 ANDA ANDA070925 Med-Health Pharma, LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 51138-018_da91ee9c-13cb-4ca0-b30c-a2686b7b699f 51138-018 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 20110110 ANDA ANDA070924 Med-Health Pharma, LLC CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 51138-019_da91ee9c-13cb-4ca0-b30c-a2686b7b699f 51138-019 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 20110110 ANDA ANDA070923 Med-Health Pharma, LLC CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 51138-033_e983ec9b-9e09-4bc6-9225-0d3a6dc77008 51138-033 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20110101 ANDA ANDA075483 Med Health Pharma, LLC ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 51138-034_e983ec9b-9e09-4bc6-9225-0d3a6dc77008 51138-034 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20110101 ANDA ANDA075483 Med Health Pharma, LLC ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 51138-035_e983ec9b-9e09-4bc6-9225-0d3a6dc77008 51138-035 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20110101 ANDA ANDA075483 Med Health Pharma, LLC ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 51138-036_e983ec9b-9e09-4bc6-9225-0d3a6dc77008 51138-036 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20110101 ANDA ANDA075483 Med Health Pharma, LLC ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 51138-038_5766088c-c0e4-423e-872e-f319090cb431 51138-038 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110101 ANDA ANDA040707 Med-Health Pharma, LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51138-039_7575a6c9-3e24-4de4-b675-77e3312cec2d 51138-039 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20121001 ANDA ANDA078558 Med Health Pharma, LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51138-040_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-040 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51138-041_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-041 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51138-042_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-042 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51138-043_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-043 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51138-044_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-044 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51138-045_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-045 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51138-046_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-046 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51138-047_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-047 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51138-048_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-048 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51138-049_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-049 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .3 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51138-052_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-052 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51138-053_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-053 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51138-054_e2447944-15e9-4074-aff0-2c90a7c04694 51138-054 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51138-055_e2447944-15e9-4074-aff0-2c90a7c04694 51138-055 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51138-056_e2447944-15e9-4074-aff0-2c90a7c04694 51138-056 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51138-057_e2447944-15e9-4074-aff0-2c90a7c04694 51138-057 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51138-058_e2447944-15e9-4074-aff0-2c90a7c04694 51138-058 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51138-059_e2447944-15e9-4074-aff0-2c90a7c04694 51138-059 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51138-060_e2447944-15e9-4074-aff0-2c90a7c04694 51138-060 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51138-061_e2447944-15e9-4074-aff0-2c90a7c04694 51138-061 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51138-062_e2447944-15e9-4074-aff0-2c90a7c04694 51138-062 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51138-063_fd8130de-c98c-4485-9e3e-93a19f20ab87 51138-063 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110105 ANDA ANDA076063 Med-Health Pharma, LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51138-064_fd8130de-c98c-4485-9e3e-93a19f20ab87 51138-064 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110105 ANDA ANDA076063 Med-Health Pharma, LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51138-065_fd8130de-c98c-4485-9e3e-93a19f20ab87 51138-065 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110105 ANDA ANDA076063 Med-Health Pharma, LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51138-066_fd8130de-c98c-4485-9e3e-93a19f20ab87 51138-066 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110105 ANDA ANDA076063 Med-Health Pharma, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51138-067_fd8130de-c98c-4485-9e3e-93a19f20ab87 51138-067 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110105 ANDA ANDA076063 Med-Health Pharma, LLC LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51138-068_fd8130de-c98c-4485-9e3e-93a19f20ab87 51138-068 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110105 ANDA ANDA076063 Med-Health Pharma, LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51138-074_ab07503b-a46a-4316-bfbe-a21168f4e6f6 51138-074 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20110104 ANDA ANDA075967 Med-Health Pharma, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 51138-075_ab07503b-a46a-4316-bfbe-a21168f4e6f6 51138-075 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20110104 ANDA ANDA075967 Med-Health Pharma, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 51138-076_ab07503b-a46a-4316-bfbe-a21168f4e6f6 51138-076 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20110104 ANDA ANDA075967 Med-Health Pharma, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 51138-077_1334edb5-8e3b-4f53-b233-3a520562f41a 51138-077 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20110101 ANDA ANDA076003 Med-Health Pharma, LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 51138-093_28b1893e-46ea-406a-82bc-10435fcca4ef 51138-093 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20110115 ANDA ANDA078619 Med-Health Pharma, LLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51138-094_28b1893e-46ea-406a-82bc-10435fcca4ef 51138-094 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20110115 ANDA ANDA078619 Med-Health Pharma, LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51138-095_28b1893e-46ea-406a-82bc-10435fcca4ef 51138-095 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20110115 ANDA ANDA078619 Med-Health Pharma, LLC FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51138-096_c2cc607c-825f-4ada-bec8-84534c901ec2 51138-096 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110120 ANDA ANDA078512 Med-Health Pharma, LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51138-097_c2cc607c-825f-4ada-bec8-84534c901ec2 51138-097 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110120 ANDA ANDA078512 Med-Health Pharma, LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51138-098_c2cc607c-825f-4ada-bec8-84534c901ec2 51138-098 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110120 ANDA ANDA078512 Med-Health Pharma, LLC ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51138-106_13c7aebd-76c8-42fe-a2bf-fafa95664747 51138-106 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20110115 ANDA ANDA074644 Med-Health Pharma, LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51138-107_13c7aebd-76c8-42fe-a2bf-fafa95664747 51138-107 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20110115 ANDA ANDA074644 Med-Health Pharma, LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51138-108_13c7aebd-76c8-42fe-a2bf-fafa95664747 51138-108 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20110115 ANDA ANDA074644 Med-Health Pharma, LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51138-109_13c7aebd-76c8-42fe-a2bf-fafa95664747 51138-109 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20110115 ANDA ANDA074644 Med-Health Pharma, LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51138-211_44f7fd62-0be0-4a87-a89e-036a0445016c 51138-211 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20120202 NDA NDA021286 Med-Health Pharma, LLC OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 51138-212_44f7fd62-0be0-4a87-a89e-036a0445016c 51138-212 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20120202 NDA NDA021286 Med-Health Pharma, LLC OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 51138-213_44f7fd62-0be0-4a87-a89e-036a0445016c 51138-213 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20120202 NDA NDA021286 Med-Health Pharma, LLC OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 51138-585_48e301c4-33b2-4544-970c-1d30a22172a6 51138-585 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20110704 ANDA ANDA077397 Med-Health Pharma, LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51138-586_48e301c4-33b2-4544-970c-1d30a22172a6 51138-586 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20110704 ANDA ANDA077864 Med-Health Pharma, LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51138-587_48e301c4-33b2-4544-970c-1d30a22172a6 51138-587 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20110704 ANDA ANDA077864 Med-Health Pharma, LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51138-588_fdf6ae68-5234-4aac-ab0d-38fa7e87f7a3 51138-588 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20110704 ANDA ANDA077836 Med-Health Pharma, LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 51141-0002_f06a5c72-ca8a-4147-9a85-ec280e40ef7e 51141-0002 HUMAN OTC DRUG Hydrocortisone HC Hydrocortisone CREAM TOPICAL 20101215 OTC MONOGRAPH NOT FINAL part348 Neopharm Co,. Ltd HYDROCORTISONE 1 g/100g 51141-0005_3b72153a-2bc7-4878-baf4-af9193e68b13 51141-0005 HUMAN OTC DRUG Muscle and Joint Menthol GEL TOPICAL 20100827 OTC MONOGRAPH NOT FINAL part348 NeoPharm Co., Ltd. MENTHOL 2.5 g/100g 51141-0054_7b5b52f3-182a-4f8e-b877-68cc5e5201d1 51141-0054 HUMAN OTC DRUG Anti Itch Cream Diphenhydramine HCl, Zinc acetate CREAM TOPICAL 20100907 OTC MONOGRAPH FINAL part336 NeoPharm Co., Ltd. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 51141-0057_0976b365-d5b5-4396-a17e-b8a1c32616e4 51141-0057 HUMAN OTC DRUG Tolnaftate Tolnaftate CREAM TOPICAL 20100827 OTC MONOGRAPH FINAL part333C NeoPharm Co., Ltd. TOLNAFTATE 1 g/100g 51141-0065_ff4b716a-95d0-4d1c-bea4-2fecd6bb5d3a 51141-0065 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part348 NeoPharm Co., Ltd. HYDROCORTISONE 1 h/100g 51141-0066_2693ab26-2139-45df-8bac-d077e5f04a09 51141-0066 HUMAN OTC DRUG Antibiotic Ointment Neomycin Sulfate OINTMENT TOPICAL 20100826 OTC MONOGRAPH FINAL part333B NeoPharm Co., Ltd. NEOMYCIN SULFATE 3.5 mg/g 51141-0070_949a5beb-b5f4-473f-82db-81fe75e86a4c 51141-0070 HUMAN OTC DRUG Triple Antibiotic Ointment Bacitracin Zinc, Neomycin Sulfate, Polymyxin B OINTMENT TOPICAL 20100901 OTC MONOGRAPH FINAL part333B NeoPharm Co., Ltd BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 51141-0220_f7034d80-4b3a-4073-9539-ec38e1bc9684 51141-0220 HUMAN OTC DRUG ATOPALM Hemorrhoidal Pain Relieving GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM CREAM TOPICAL 20120117 OTC MONOGRAPH FINAL part346 NeoPharm USA GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g 51141-0230_d3cf0652-d915-4d32-8f38-dc3df1283b2e 51141-0230 HUMAN OTC DRUG ATOPALM Hemorrhoidal MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE OINTMENT TOPICAL 20120718 OTC MONOGRAPH FINAL part346 NeoPharm USA MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 71.9; .25 g/100g; g/100g; g/100g 51141-0235_376015fa-7b2c-4a5a-8a9d-faf7a3a7e7ce 51141-0235 HUMAN OTC DRUG ATOPALM Deep Penetrating Pain Relieving MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20120117 OTC MONOGRAPH NOT FINAL part348 NeoPharm Co., Ltd. MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g 51141-0236_c4960e55-2361-47fe-a60d-bf0fbf2d0c66 51141-0236 HUMAN OTC DRUG ATOPALM Oral Pain Relief BENZOCAINE GEL ORAL 20120206 OTC MONOGRAPH NOT FINAL part356 NeoPharm, USA BENZOCAINE 10 g/100g 51141-0237_da4fcde6-b7da-4442-ba8e-3793aa624d11 51141-0237 HUMAN OTC DRUG ATOPALM Diaper Rash ZINC OXIDE CREAM TOPICAL 20120607 OTC MONOGRAPH NOT FINAL part347 NeoPharm Co., Ltd ZINC OXIDE 10 g/100g 51141-0238_5759545b-d8a3-4d33-952d-a79139997840 51141-0238 HUMAN OTC DRUG ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING AND PAIN RELIEF BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYCIN B SULFATE, PRAMOXINE HCL OINTMENT TOPICAL 20120808 OTC MONOGRAPH FINAL part333B Neopharm Co., Ltd. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g 51141-0239_0bb2e368-a9b1-4db4-929a-73afbdd08c7d 51141-0239 HUMAN OTC DRUG ATOPALM PAIN RELIEVING MENTHOL CREAM TOPICAL 20120814 OTC MONOGRAPH NOT FINAL part348 NeoPharm Co., Ltd. MENTHOL 10 g/100g 51141-0240_052948a7-37b8-4731-b064-2ff9721bc7a0 51141-0240 HUMAN OTC DRUG ATOPALM MUSCLE AND JOINT MENTHOL GEL TOPICAL 20120814 OTC MONOGRAPH NOT FINAL part348 NeoPharm Co., Ltd. MENTHOL 2.5 g/100g 51141-0300_fda914e0-dcb4-4b66-acf4-a699437498bd 51141-0300 HUMAN OTC DRUG ATOPALM BB LIGHT SPF 20 BROAD SPECTRUM SUNSCREEN OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120802 OTC MONOGRAPH FINAL part352 Neopharm Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE 7.5; 8 g/100g; g/100g 51141-0301_541ab30f-4d1f-42db-a364-18ab5f4e5e74 51141-0301 HUMAN OTC DRUG ATOPALM BB MEDIUM SPF 20 BROAD SPECTRUM SUNSCREEN OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120802 OTC MONOGRAPH FINAL part352 Neopharm Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE 7.5; 8 g/100g; g/100g 51141-0657_84b3da7b-0fec-450f-8af3-3c38eccbb5c5 51141-0657 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20100902 OTC MONOGRAPH FINAL part333C NeoPharm Co., Ltd. CLOTRIMAZOLE 1 g/100g 51141-0659_6ee5cd72-9e86-4526-af8a-417536369c62 51141-0659 HUMAN OTC DRUG Muscle Rub Ultra Camphor,Menthol, methyl salicylate CREAM TOPICAL 20100816 OTC MONOGRAPH NOT FINAL part348 NeoPharm Co., Ltd. CAMPHOR (NATURAL); MENTHOL; MENTHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g 51141-0700_c81341b8-0ce2-4153-b3dc-26a134fcc06c 51141-0700 HUMAN OTC DRUG MAXFIT FREEZE GEL MENTHOL GEL TOPICAL 20140812 OTC MONOGRAPH NOT FINAL part348 NeoPharm USA MENTHOL 50 mg/mL 51141-1000_a4e0c7e6-c560-4b32-8e6b-40fc8b938dea 51141-1000 HUMAN OTC DRUG ATOPALM CLOTRIMAZOLE ANTIFUNGAL CLOTRIMAZOLE CREAM TOPICAL 20110316 OTC MONOGRAPH NOT FINAL part333C NeoPharm Co., Ltd. CLOTRIMAZOLE 1 g/100g 51141-2000_9b285fe9-710c-4000-b778-900599c84b19 51141-2000 HUMAN OTC DRUG ATOPALM TOLNAFTATE ANTIFUNGAL TOLNAFTATE CREAM TOPICAL 20110316 OTC MONOGRAPH FINAL part333C Neopharm Co., Ltd. TOLNAFTATE 1 g/100g 51141-3000_fcba993b-22a9-47ae-b8e5-e17307ac2681 51141-3000 HUMAN OTC DRUG Atopalm First Aid Triple Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYCIN B SULFATE OINTMENT TOPICAL 20110316 OTC MONOGRAPH FINAL part333B Neopharm Co., Ltd. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 51141-3771_bf67676c-618d-4074-8dde-e70870d4c1c1 51141-3771 HUMAN OTC DRUG Muscle Rub Greaseless Menthol, methyl salicylate CREAM TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part348 NeoPharm Co., Ltd. MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g 51141-4000_8d8b5dbd-d3c2-483e-ab8f-9f919bae3a44 51141-4000 HUMAN OTC DRUG Atopalm Itch Relief DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20110316 OTC MONOGRAPH FINAL part347 Neopharm Co, Ltd DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 51141-5000_b749cb44-df6d-44ac-a6c5-1bebe8d08d71 51141-5000 HUMAN OTC DRUG ATOPALM MOISTURIZING MUSCLE RUB CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20110316 OTC MONOGRAPH FINAL part348 NeoPharm Co., Ltd. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g 51141-6000_e2153b65-5edd-491c-885d-9567d0bf7ea5 51141-6000 HUMAN OTC DRUG ATOPALM Moisturizing Hydrocortisone HYDROCORTISONE CREAM TOPICAL 20110317 OTC MONOGRAPH NOT FINAL part348 NeoPharm Co., Ltd. HYDROCORTISONE 1 g/100g 51141-6010_710fc8e8-7ab6-4ef3-814a-05f52360f8b9 51141-6010 HUMAN OTC DRUG Atopalm Maximum Strength Anti-Itch HYDROCORTISONE OINTMENT TOPICAL 20111104 OTC MONOGRAPH FINAL part348 NeoPharm Co., Ltd. HYDROCORTISONE 1 g/100g 51141-7000_7504a18f-1c22-4f87-95f3-97b65a9a9976 51141-7000 HUMAN OTC DRUG Atopalm Acne Controlling SALICYLIC ACID LOTION TOPICAL 20111104 OTC MONOGRAPH FINAL part333D NeoPharm Co., Ltd. SALICYLIC ACID 2 mL/100mL 51141-8000_0d5962f6-76e3-48f6-953e-60e2a3422692 51141-8000 HUMAN OTC DRUG PSORIAPALM Non-Greasy Psoriasis SALICYLIC ACID LOTION TOPICAL 20120704 OTC MONOGRAPH FINAL part358H Neopharm Co., Ltd SALICYLIC ACID 2 mL/100mL 51143-002_cf6a5515-8219-4a1e-a979-7355764f5b53 51143-002 HUMAN OTC DRUG Live Better Antifungal Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C The Great Atlantic & Pacific Tea Company CLOTRIMAZOLE 10 mg/g 51143-004_d1ea75ce-a6aa-47f8-bb70-41a84c9548c9 51143-004 HUMAN OTC DRUG Fluoride Rinse for Kids SODIUM FLUORIDE RINSE ORAL 20090908 OTC MONOGRAPH FINAL part355 The Great Atlantic + Pacific Tea Company SODIUM FLUORIDE .05 kg/100L 51143-016_68e38274-620e-4208-bb24-9e0cf9d6350d 51143-016 HUMAN OTC DRUG Live Better Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B The Great Atlantic & Pacific Tea Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 51143-027_668f2236-2b77-4460-992a-8f37281fa18e 51143-027 HUMAN OTC DRUG Live Better Triple Antibiotic plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B The Great Atlantic & Pacific Tea Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g 51143-053_a3143a69-62b2-40e2-98fd-86666cc9b525 51143-053 HUMAN OTC DRUG Hand Sanitizer ALCOHOL LIQUID TOPICAL 19991218 OTC MONOGRAPH NOT FINAL part333E The Great Atlantic + Pacific Tea Company ALCOHOL 62 kg/100L 51143-059_39364dbe-6c30-4a18-8755-747f224fea5d 51143-059 HUMAN OTC DRUG Live Better Hydrocortisone with Aloe Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 The Great Atlantic & Pacific Tea Company HYDROCORTISONE 1 g/100g 51143-066_260f9fef-5e12-4235-ad27-c9d24f7e90d8 51143-066 HUMAN OTC DRUG Live Better Anti-Itch Diphenhydramine hydrochloride and Zinc acetate CREAM TOPICAL 20050920 OTC MONOGRAPH FINAL part348 The Great Atlantic & Pacific Tea Company DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g 51143-069_dd86e483-0aba-4556-bbad-6f74f22e5cbb 51143-069 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20091014 OTC MONOGRAPH FINAL part347 Onpoint, Inc PETROLATUM 1 g/g 51143-072_9697dc71-57dc-46d9-a474-ff5a2d154d85 51143-072 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol MOUTHWASH ORAL 20090727 OTC MONOGRAPH NOT FINAL part348 Onpoint, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 51143-075_25047950-6d46-494d-b913-e7e1282a50cc 51143-075 HUMAN OTC DRUG Live Better Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B The Great Atlantic & Pacific Tea Company BACITRACIN ZINC 500 [iU]/g 51143-076_6f29b07f-7ffe-4a75-8ba9-88964b688111 51143-076 HUMAN OTC DRUG LiveBetter Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B The Great Atlantic & Pacific Tea Company NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g 51143-080_5815e784-340a-4dd5-ad4b-473b8218a257 51143-080 HUMAN OTC DRUG Live Better Antifungal Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 The Great Atlantic & Pacific Tea Company TERBINAFINE HYDROCHLORIDE 1 g/100g 51143-092_f2e73f4c-202e-41bc-8d51-72fdad9273ab 51143-092 HUMAN OTC DRUG Live Better Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 The Great Atlantic & Pacific Tea Company LORATADINE 5 mg/5mL 51143-124_d8bbf47e-25bc-4d45-86f4-7ab113bbb878 51143-124 HUMAN OTC DRUG Antispetic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20100716 OTC MONOGRAPH NOT FINAL part348 Onpoint, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 51143-153_7930d7aa-4e83-4d2f-93de-3a8871b19354 51143-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H On-Point, Inc PYRITHIONE ZINC 1 kg/100L 51143-163_5b3c64b4-2230-45e1-8f65-6d7c275049a2 51143-163 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20100716 OTC MONOGRAPH FINAL part355 Onpointm, Inc SODIUM FLUORIDE .1 mg/mL 51143-203_24e11b1f-1102-405a-955e-272de7fad43b 51143-203 HUMAN OTC DRUG Waterless Hand Sanitizer Alcohol GEL TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333A Onpoinr, Inc ALCOHOL .65 mL/100L 51143-210_31651900-c5ae-4827-a592-8ad685d25dc2 51143-210 HUMAN OTC DRUG Antiseptic Eucalyptol MOUTHWASH ORAL 20101019 OTC MONOGRAPH NOT FINAL part356 Onpoint, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 mL/100L; mL/100L; mL/100L; mL/100L 51143-213_0ad88aff-7c4f-4dff-992b-eac787bdce42 51143-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20101112 OTC MONOGRAPH FINAL part355 The Great Atlantic + Pacific Tea Company SODIUM FLUORIDE .05 kg/100L 51143-243_4548125e-0777-4f2f-993c-d2752b3db3a6 51143-243 HUMAN OTC DRUG Antibacterial Hand Triclosan LIQUID TOPICAL 20090226 OTC MONOGRAPH FINAL part333A OnPoint, Inc TRICLOSAN .15 kg/100L 51143-279_709df7a8-9871-4e9c-8201-bc8b42667809 51143-279 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part333A Onpoint, Inc BENZALKONIUM CHLORIDE 1.3 g/mL 51143-281_020be78e-3d9c-41ed-982c-f3b0189be1c2 51143-281 HUMAN OTC DRUG Dry Scalp Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20120702 OTC MONOGRAPH FINAL part358H OnPoint, Inc PYRITHIONE ZINC 1 kg/100L 51143-296_d0348ba3-1e82-4664-8567-6b8fd1f951d0 51143-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 19980304 OTC MONOGRAPH FINAL part358H OnPoint, Inc PYRITHIONE ZINC 10 mg/mL 51143-299_693d52a3-6fd9-4b58-b3bc-9966f529b24b 51143-299 HUMAN OTC DRUG Antiseptic Cetylpyridinium chloride MOUTHWASH ORAL 20100727 OTC MONOGRAPH NOT FINAL part356 Onpoint, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL 51143-311_99eef95c-997b-41b0-8aa2-f09f2bb159fe 51143-311 HUMAN OTC DRUG Everyday Clean Pyrithione Zinc SHAMPOO TOPICAL 20010103 OTC MONOGRAPH FINAL part358H OnPoint, Inc. PYRITHIONE ZINC 1 g/100mL 51143-318_7baa33c2-74b0-478a-8613-b6b9413c6dc3 51143-318 HUMAN OTC DRUG Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20090727 OTC MONOGRAPH NOT FINAL part356 Onpoint, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 51143-370_d9e56096-8a5e-43ca-ba00-1a2e36ef41ac 51143-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20140928 OTC MONOGRAPH NOT FINAL part333A Onpoint, Inc ALCOHOL 70 mL/100mL 51143-403_58237791-df3f-4208-b44c-529eb1015669 51143-403 HUMAN OTC DRUG Hand wash Benzalkonium chloride LIQUID TOPICAL 20140728 OTC MONOGRAPH NOT FINAL part333A Onpoint, Inc BENZALKONIUM CHLORIDE 1.3 mg/mL 51143-434_3ef57ef8-2eba-46db-9909-631130e76e5a 51143-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130613 OTC MONOGRAPH NOT FINAL part356 Onpoint, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 51143-439_5882cda0-ba35-48e1-9087-a2d5bbbe8851 51143-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140930 OTC MONOGRAPH NOT FINAL part333A Onpoint, Inc. ALCOHOL 700 mg/mL 51143-541_1412fee9-1ac0-472d-868c-542a1db339b8 51143-541 HUMAN OTC DRUG Antibacterial Liquid Hand TRICLOSAN LIQUID TOPICAL 20090730 OTC MONOGRAPH NOT FINAL part333A OnPoint, Inc TRICLOSAN .115 kg/100L 51143-545_c901099d-e225-4f32-aa90-d66dc019afbf 51143-545 HUMAN OTC DRUG Waterless Hand Sanitizer ALCOHOL GEL TOPICAL 20090109 OTC MONOGRAPH NOT FINAL part333A ONPOINT, INC ALCOHOL .62 kg/100L 51143-619_05477f45-4beb-4c10-9bf3-0eeea55e709a 51143-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20110222 OTC MONOGRAPH FINAL part347 OnPoint, Inc DIMETHICONE 13.13 mg/mL 51143-641_5e5347df-3b97-48de-99e0-0a6be3bfdb00 51143-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140819 OTC MONOGRAPH NOT FINAL part333A Onpoint, Inc BENZALKONIUM CHLORIDE .999 mg/mL 51143-693_7db98376-6249-4a52-afae-ca47859a7f04 51143-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20090625 OTC MONOGRAPH NOT FINAL part334 OnPoint, Inc MAGNESIUM CITRATE 1.745 g/29.6mL 51143-871_dfdcd487-d5b1-4930-9292-0e3fdafad9aa 51143-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19960320 OTC MONOGRAPH NOT FINAL part333A The Great Atlantic + Pacific Tea Company HYDROGEN PEROXIDE .3 kg/100L 51143-962_75a09af3-8d48-4d05-a939-6b548816fdcc 51143-962 HUMAN OTC DRUG Foaming Hand Wash Triclosan LIQUID TOPICAL 20120816 OTC MONOGRAPH NOT FINAL part333A Onpoint, Inc TRICLOSAN .46 mg/mL 51143-966_61ae85f9-238c-40bc-b2fc-bc335d78f3af 51143-966 HUMAN OTC DRUG Anticavity Sdoium Fluoride MOUTHWASH ORAL 20120321 OTC MONOGRAPH FINAL part355 Onpoint, Inc SODIUM FLUORIDE .0221 mL/100L 51144-050_f4370bec-3fc6-f833-ebc4-c1cc262b99dc 51144-050 HUMAN PRESCRIPTION DRUG ADCETRIS brentuximab vedotin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110825 BLA BLA125388 Seattle Genetics, Inc. BRENTUXIMAB VEDOTIN 50 mg/10.5mL CD30-directed Antibody Interactions [MoA],CD30-directed Immunoconjugate [EPC],Immunoconjugates [Chemical/Ingredient],Microtubule Inhibition [PE] 51147-5010_14f39df9-e360-41ef-a046-da5c81c6cea1 51147-5010 HUMAN OTC DRUG Becca Mineral SPF Primer Zinc Oxide CREAM TOPICAL 20110412 OTC MONOGRAPH NOT FINAL part352 Becca, Inc. ZINC OXIDE 17 mL/100mL 51150-066_c9091085-68a8-4ca4-ba79-8b1e9ee0da55 51150-066 HUMAN OTC DRUG Giorgio Armani Crema Nera OMC3 Obsidian Mineral Restoring Cream SPF 15 Avobenzone Octislate Octocrylene CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 Sicos Et Cie (Lancome) AVOBENZONE; OCTISALATE; OCTOCRYLENE 1; 2.5; 4 mL/50mL; mL/50mL; mL/50mL 51150-409_cf3ca068-2f16-4e0f-8307-0ae7da14fe4f 51150-409 HUMAN OTC DRUG Yves Saint Laurent Teint Resist Long Wear Endless Comfort Transfer Resistant Foundation SPF 10 Titanium Dioxide LOTION TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Sicos Et Cie (Lancome) TITANIUM DIOXIDE 1.809 mL/30mL 51151-000_d384bb5a-4e76-4578-a7f0-9fc13c6559b9 51151-000 HUMAN OTC DRUG CIDACIN Antifungal Treatment TOLNAFTATE SOLUTION TOPICAL 20120607 OTC MONOGRAPH FINAL part333C Pedicis Research LLC TOLNAFTATE 1 mL/100mL 51167-200_0178bce3-e1ae-4a30-beb9-1d853a5e47d3 51167-200 HUMAN PRESCRIPTION DRUG Kalydeco ivacaftor TABLET, FILM COATED ORAL 20120131 NDA NDA203188 Vertex Pharmaceuticals Incorporated IVACAFTOR 150 mg/1 Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC],Chloride Channel Activation Potentiators [MoA],Cytochrome P450 3A4 Inhibitors [MoA] 51191-2013_2d09ef8e-d57e-4212-b2c2-6dbe4358e864 51191-2013 HUMAN OTC DRUG 6 CREME 410 TEINTEE OCTINOXATE CREAM TOPICAL 20110215 OTC MONOGRAPH FINAL part352 MULTALER & CIE S.A. OCTINOXATE 5 g/100g 51191-2015_c900cb39-d795-49dd-ab8f-98b4c4934c19 51191-2015 HUMAN OTC DRUG SPF 40 UVA/UVB titanium dioxide, octinoxate, octisalate, homosalate CREAM TOPICAL 20110215 OTC MONOGRAPH FINAL part352 MULTALER & CIE S.A. HOMOSALATE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 4; 7.5; 5; 11 g/100g; g/100g; g/100g; g/100g 51191-2016_9836c805-113a-4863-bbc9-7c3b80849815 51191-2016 HUMAN OTC DRUG ULTRAPROTECTION Octinoxate, Titanium dioxide CREAM TOPICAL 20110215 OTC MONOGRAPH FINAL part352 MULTALER & CIE S.A. OCTINOXATE; TITANIUM DIOXIDE 7.5; 4.98 g/100g; g/100g 51191-2046_55af296c-bfb0-450a-8477-28f790d05ebd 51191-2046 HUMAN OTC DRUG SPF 20 UVA/UVB HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part352 MULTALER ET CIE S.A.S. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 7.5; 5; 2.7; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 51191-3015_57702643-a673-47b1-8dde-a02749b62f6e 51191-3015 HUMAN OTC DRUG SPF 50 UVA/UVB ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part352 MULTALER ET CIE S.A.S. AVOBENZONE; ENSULIZOLE; OCTOCRYLENE; OXYBENZONE 3; 3; 8; 5 g/100g; g/100g; g/100g; g/100g 51191-3016_a8db6898-b7c2-4646-a1ce-a502ee7b68ab 51191-3016 HUMAN OTC DRUG SPF 25 UVA/UVB ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part352 MULTALER ET CIE S.A.S. AVOBENZONE; ENSULIZOLE; OCTOCRYLENE; OXYBENZONE 3; 3; 6; 5 g/100g; g/100g; g/100g; g/100g 51198-001_87b93f2e-21ab-420a-bb40-fce5adaa8387 51198-001 HUMAN OTC DRUG VEHICLE BOAT BAG MEDICAL CHLOROXYLENOL CLOTH TOPICAL 20100923 OTC MONOGRAPH NOT FINAL part333E JBC CORP CHLOROXYLENOL .5 g/100g 51201-100_dcd3becb-3622-4e88-a2f0-596f2d72fcd2 51201-100 HUMAN OTC DRUG MINI HAND SANITIZER - ORANGE AND LEMON ALCOHOL LIQUID TOPICAL 20100725 OTC MONOGRAPH FINAL part333 Goldessence, Limited ALCOHOL 62 mL/100mL 51201-101_0697a512-4f54-4795-8f86-dbf7db5a5d03 51201-101 HUMAN OTC DRUG MINI HAND SANITIZER - COCONUT AND LIME ALCOHOL LIQUID TOPICAL 20100725 OTC MONOGRAPH FINAL part333 Goldessence, Limited ALCOHOL 62 mL/100mL 51201-200_2f0de399-291f-404a-9e95-5f2bad98535d 51201-200 HUMAN OTC DRUG COCONUT LIME ANTIBACTERIAL SANITIZER ALCOHOL LIQUID TOPICAL 20100725 OTC MONOGRAPH FINAL part333 Goldessence, Limited ALCOHOL 62 mL/100mL 51201-201_a0fd97d6-5b73-4581-8842-da2293c790be 51201-201 HUMAN OTC DRUG CUCUMBER MELON ANTIBACTERIAL SANITIZER ALCOHOL LIQUID TOPICAL 20100725 OTC MONOGRAPH FINAL part333 Goldessence, Limited ALCOHOL 62 mL/100mL 51201-202_d7343886-a215-4690-9610-f4389b2d285d 51201-202 HUMAN OTC DRUG JASMINE AND GREEN TEA ANTIBACTERIAL SANITIZER ALCOHOL LIQUID TOPICAL 20100725 OTC MONOGRAPH FINAL part333 Goldessence, Limited ALCOHOL 62 mL/100mL 51201-203_91d45b14-d2ee-4114-a7de-01acce045d70 51201-203 HUMAN OTC DRUG MANDARIN ORANGE AND LEMON ANTIBACTERIAL SANITIZER ALCOHOL LIQUID TOPICAL 20100725 OTC MONOGRAPH FINAL part333 Goldessence, Limited ALCOHOL 62 mL/100mL 51206-201_e6e3201b-57b9-4053-85f4-622c8898f6c4 51206-201 HUMAN OTC DRUG Ultracare Anesthetic Bubble Gum Benzocaine GEL DENTAL 19860601 OTC MONOGRAPH NOT FINAL part356 Ultradent Products, Inc. BENZOCAINE 6.96 g/30mL 51206-202_9ffc7c05-81d5-4d07-8690-dd400e2ab571 51206-202 HUMAN OTC DRUG Ultracare Anesthetic Walterberry Benzocaine GEL DENTAL 19930601 OTC MONOGRAPH NOT FINAL part356 Ultradent Products, Inc. BENZOCAINE 6.96 g/30mL 51206-203_e3e16387-cdd1-43c9-bc45-352a5cb08d31 51206-203 HUMAN OTC DRUG Ultracare Anesthetic Butter Rum Benzocaine GEL DENTAL 19860601 OTC MONOGRAPH NOT FINAL part356 Ultradent Products, Inc. BENZOCAINE 6.96 g/30mL 51206-204_9fe42dc7-2009-406a-9adc-286abb1a4020 51206-204 HUMAN OTC DRUG Ultracare Anesthetic Pina Colada Benzocaine GEL DENTAL 19860601 OTC MONOGRAPH NOT FINAL part356 Ultradent Products, Inc. BENZOCAINE 6.96 g/30mL 51206-205_00beae87-6482-4afd-9fb0-2eb09cbad645 51206-205 HUMAN OTC DRUG Ultracare Anesthetic Creme de Menthe Benzocaine GEL DENTAL 19860601 OTC MONOGRAPH NOT FINAL part356 Ultradent Products, Inc. BENZOCAINE 6.96 g/30mL 51206-302_35da460e-d4d8-493b-bf04-540a229ea371 51206-302 HUMAN OTC DRUG Opalescence Whitening Toothpaste Sodium Fluoride GEL, DENTIFRICE DENTAL 19940701 OTC MONOGRAPH FINAL part355 Ultradent Products, Inc. SODIUM FLUORIDE .070875 g/28.35g 51206-303_cf9374d9-3fe6-456f-b447-b66386decefb 51206-303 HUMAN OTC DRUG Opalescence PF Sodium Fluoride and Potassium Nitrate PASTE, DENTIFRICE DENTAL 20101115 OTC MONOGRAPH FINAL part355 Ultradent Products, Inc. POTASSIUM NITRATE; SODIUM FLUORIDE 1.4175; .070875 g/28.35g; g/28.35g 51206-304_b11750bd-1bd0-4cc9-904c-86e8bba903aa 51206-304 HUMAN OTC DRUG Opalescence Plus Sodium Fluoride PASTE, DENTIFRICE DENTAL 20101115 OTC MONOGRAPH FINAL part355 Ultradent Products, Inc. SODIUM FLUORIDE .070875 g/28.35g 51206-305_64ce5a09-f0dc-489c-81df-07690545e979 51206-305 HUMAN OTC DRUG Xylishield Sodium Fluoride PASTE, DENTIFRICE DENTAL 20101027 OTC MONOGRAPH FINAL part355 Ultradent Products, Inc. SODIUM FLUORIDE .3325 g/133g 51206-401_d31c7e87-bcdf-487d-bb25-a841678dc35e 51206-401 HUMAN PRESCRIPTION DRUG Flor-Opal Sustained-Release Fluoride Sodium Fluoride GEL DENTAL 19900531 UNAPPROVED DRUG OTHER Ultradent Products, Inc SODIUM FLUORIDE 5 mg/mL 51208-001_7a1d4182-83f7-4e6d-88e4-0f41a3eb9822 51208-001 HUMAN OTC DRUG Childrens Strength Pain and Fever Relief Acetaminophen TABLET, CHEWABLE ORAL 20140318 OTC MONOGRAPH NOT FINAL part343 ScripsAmerica ACETAMINOPHEN 80 mg/1 51208-002_65895742-c4d9-4421-96f3-b015dbd0228f 51208-002 HUMAN OTC DRUG Childrens Pain and Fever Relief Wild Grape Flavor Acetaminophen TABLET, CHEWABLE ORAL 20041206 OTC MONOGRAPH NOT FINAL part343 ScripsAmerica ACETAMINOPHEN 80 mg/1 51208-003_ee4e21ac-41dc-464a-a291-828b898c0855 51208-003 HUMAN OTC DRUG Junior Strength Pain and Fever Relief Wild Cherry Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 ScripsAmerica ACETAMINOPHEN 160 mg/1 51208-004_f4883de5-06a5-4dda-9426-e3bb00134872 51208-004 HUMAN OTC DRUG Junior Strength Pain and Fever Relief Wild Grape Flavor Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 ScripsAmerica ACETAMINOPHEN 160 mg/1 51209-001_cfe6b69f-842d-44ae-a11c-d34ff20de7a8 51209-001 HUMAN OTC DRUG dalan Therapy ANTIBACTERIAL and odor neutralizer TRICLOSAN LIQUID TOPICAL 20140806 OTC MONOGRAPH NOT FINAL part333E Dalan Kimya Endustri A.S. TRICLOSAN 1 mg/mL 51209-002_0ad59dd7-e2d3-4700-a845-56028a26374b 51209-002 HUMAN OTC DRUG dalan GOLDEN TROPICS antibacterial deodorant TRICLOSAN SOAP TOPICAL 20140806 OTC MONOGRAPH NOT FINAL part333E Dalan Kimya Endustri A.S. TRICLOSAN .1 g/100g 51209-003_aff1b39b-0e4b-46f4-941d-f4bae6bcfd3b 51209-003 HUMAN OTC DRUG dalan OCEAN BREEZE antibacterial deodorant TRICLOSAN SOAP TOPICAL 20140806 OTC MONOGRAPH NOT FINAL part333E Dalan Kimya Endustri A.S. TRICLOSAN .1 g/100g 51209-004_459b0525-27ef-45b1-b4de-f61daffe5aaa 51209-004 HUMAN OTC DRUG dalan SPRING FRESHNESS antibacterial deodorant TRICLOSAN SOAP TOPICAL 20140806 OTC MONOGRAPH NOT FINAL part333E Dalan Kimya Endustri A.S. TRICLOSAN .1 g/100g 51220-1001_b4dbd597-f3e4-4817-9ed2-93990eb89a63 51220-1001 HUMAN OTC DRUG Fresh Morning Bifidus bifidus lactobacillus POWDER ORAL 20100821 UNAPPROVED DRUG OTHER Saimdang Cosmetics Co., Ltd LACTIC ACID .0316 mg/mg 51220-2001_80171c6e-b6b6-4436-a3bf-5ef28d3d2d52 51220-2001 HUMAN OTC DRUG Multi Vitamin and Mineral vitamin ascorbic TABLET, CHEWABLE ORAL 20100821 UNAPPROVED DRUG OTHER Saimdang Cosmetics Co., Ltd .ALPHA.-TOCOPHEROL ACETATE, D-; ASCORBIC ACID; CALCIUM PANTOTHENATE; FOLIC ACID; MANGANESE; MANGANESE; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; ZINC OXIDE 10; 35; 1.5; .1; .76; 1.2; 7.5; .4; .3; .36; 3.5; 4.3 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 51220-3001_f5947cf3-6d68-4e42-bc24-b99ecbc5d0f6 51220-3001 HUMAN OTC DRUG Pure Calcium calcium calcium TABLET, CHEWABLE ORAL 20100824 UNAPPROVED DRUG OTHER Saimdang Cosmetics Co., Ltd CALCIUM; CHOLECALCIFEROL; MANGANESE 435; 1.2; 1.7 mg/1; mg/1; mg/1 51220-4001_82c2d9cd-e7ab-4603-959e-c3435b479210 51220-4001 HUMAN OTC DRUG Cheon Shim Bo Yun N-ACETYLGLUCOSAMINE CAPSULE ORAL 20101108 UNAPPROVED DRUG OTHER Saimdang Cosmetics Co., Ltd .ALPHA.-TOCOPHEROL ACETATE, D-; N-ACETYLGLUCOSAMINE; SOY ISOFLAVONES 3; 263; 30 mg/1; mg/1; mg/1 51220-5001_6b444347-e6ec-491a-b404-b786989ba4fc 51220-5001 HUMAN OTC DRUG Cheon Shim Bo Hwa borage oil CAPSULE ORAL 20110406 UNAPPROVED DRUG OTHER Saimdang Cosmetics Co., Ltd .ALPHA.-TOCOPHEROL ACETATE, D-; BORAGE OIL 1; 311 mg/1; mg/1 51224-101_52e7ba6a-27ac-4863-86ac-4cab670fbf8c 51224-101 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20110308 ANDA ANDA200272 TAGI Pharma, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 51224-102_1d67379d-4e54-4a92-b65e-b723f62a1580 51224-102 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20120309 ANDA ANDA076723 TAGI Pharma, Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 51224-151_ca854d27-fdf6-4691-9a8e-594feefeb6a5 51224-151 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20110415 ANDA ANDA075517 TAGI Pharma, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 51224-153_fb7d0866-c5b6-40ac-ac3d-7903d40ac92b 51224-153 HUMAN OTC DRUG Aluminum Acetate Astringent Calcium Acetate and Aluminum sulfate POWDER, FOR SOLUTION TOPICAL 20110615 OTC MONOGRAPH FINAL part347 TAGI Pharma Incorporated ALUMINUM SULFATE; CALCIUM ACETATE 1191; 839 mg/2030mg; mg/2030mg 51224-154_9efdf98f-92a2-43ba-a854-d21039731bb5 51224-154 HUMAN PRESCRIPTION DRUG Flavoxate Hydrochloride Flavoxate hydrochloride TABLET, FILM COATED ORAL 20110325 ANDA ANDA076835 TAGI Pharma, Inc. FLAVOXATE HYDROCHLORIDE 100 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 51224-162_3df1c75d-2a03-48b1-9943-4d6ca9929fa2 51224-162 HUMAN OTC DRUG Astringent Calcium acetate monohydrate and Aluminum sulfate tetradecahydrate POWDER, FOR SOLUTION TOPICAL 20120601 OTC MONOGRAPH FINAL part347 TAGI Pharma Inc. ALUMINUM SULFATE TETRADECAHYDRATE; CALCIUM ACETATE MONOHYDRATE 1347; 952 mg/2299mg; mg/2299mg 51224-202_15c4f79e-34cb-447a-8622-5b57fb86d5b5 51224-202 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20130416 ANDA ANDA202248 TAGI Pharma, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 51224-203_15c4f79e-34cb-447a-8622-5b57fb86d5b5 51224-203 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20130416 ANDA ANDA202248 TAGI Pharma, Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 51224-206_c01fef04-5201-4a2a-be9f-59955c45d1dc 51224-206 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 20130923 ANDA ANDA075274 TAGI Pharma Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] 51224-300_b73d3aee-116e-4a66-9993-0a163a8f95cc 51224-300 HUMAN PRESCRIPTION DRUG Codeine Sulfate Codeine Sulfate SOLUTION ORAL 20120601 NDA NDA202245 TAGI Pharma, Inc. CODEINE SULFATE 30 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 51224-301_f0c3233a-22f4-43a1-8602-501fbaf13644 51224-301 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium SOLUTION ORAL 20130506 ANDA ANDA090520 TAGI Pharma, Inc. ALENDRONATE SODIUM 70 mg/75mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 51224-400_9cddedbb-5475-43ea-be49-5f50005baeb7 51224-400 HUMAN OTC DRUG Benzoyl Peroxide Emollient Benzoyl Peroxide AEROSOL, FOAM TOPICAL 20131011 OTC MONOGRAPH FINAL part333D TAGI Pharma Inc. BENZOYL PEROXIDE 53 mg/g 51224-401_105f7ad9-e111-4ec0-91d3-c1a3ddb64c20 51224-401 HUMAN OTC DRUG Benzoyl Peroxide Emollient Benzoyl Peroxide AEROSOL, FOAM TOPICAL 20131011 OTC MONOGRAPH FINAL part333D TAGI Pharma Inc. BENZOYL PEROXIDE 98 mg/g 51230-391_52adf0e7-14dd-4833-a166-1a4afff4ff11 51230-391 HUMAN OTC DRUG NOXICARE .Alpha.-Lipoic Acid, Turmeric, Ocimum Tenuiflorum Top, Indian Frankincense, Rosemary, Salix Alba Bark, and Ginger CREAM TOPICAL 20120914 UNAPPROVED HOMEOPATHIC Truceuticals, LLC .ALPHA.-LIPOIC ACID; GINGER; INDIAN FRANKINCENSE; OCIMUM TENUIFLORUM TOP; ROSEMARY; SALIX ALBA BARK; TURMERIC 4; 4; 4; 4; 4; 4; 4 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 51230-418_65a2b1c2-7a19-4df2-8695-5b5c54983d65 51230-418 HUMAN OTC DRUG Tru-micin Trolamine LOTION TOPICAL 20130607 OTC MONOGRAPH NOT FINAL part348 Truceuticals, LLC TROLAMINE .1 mg/mL 51230-824_ddafa3ab-c669-4a06-87be-0d31f16d6ce4 51230-824 HUMAN OTC DRUG NOXICARE Natural Pain Relief .Alpha.-Lipoic Acid, Turmeric, Ocimum Tenuiflorum Top, Indian Frankincense, Rosemary, Salix Alba Bark, and Ginger CAPSULE ORAL 20120914 UNAPPROVED HOMEOPATHIC Truceuticals, LLC .ALPHA.-LIPOIC ACID; GINGER; INDIAN FRANKINCENSE; OCIMUM TENUIFLORUM TOP; ROSEMARY; SALIX ALBA BARK; TURMERIC 1; 1; 1; 1; 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 51239-0912_287886e6-b82e-4856-963e-c39b6c247b7a 51239-0912 HUMAN OTC DRUG SCRUBS Solar Guard Sunscreen Wipe SCRUBS Solar Guard Sunscreen Wipe CLOTH TOPICAL 20100301 OTC MONOGRAPH FINAL part352 ITW Dymon HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 40; 50 g/856mL; g/856mL; g/856mL; g/856mL 51239-0929_8b15acec-ee51-43ae-8362-b58ec11156b4 51239-0929 HUMAN OTC DRUG SCRUBS Lemon Hand Sanitizer Wipes SCRUBS Hand Sanitizer Wipes CLOTH TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 ITW Dymon BENZALKONIUM CHLORIDE; BENZETHONIUM CHLORIDE .1; .1 g/970mL; g/970mL 51239-1929_5eb2636c-513f-4fdb-9ea4-8ca7270041a0 51239-1929 HUMAN OTC DRUG SCRUBS Foaming Hand Sanitizer SCRUBS Hand Sanitizer Foam SOLUTION TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 ITW Dymon BENZALKONIUM CHLORIDE; BENZETHONIUM CHLORIDE .1; .1 g/970mL; g/970mL 51248-150_9d4c0f37-4aa2-4b61-a643-444519206779 51248-150 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20050105 NDA NDA021518 Astellas Pharma Technologies, Inc. SOLIFENACIN SUCCINATE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 51248-151_9d4c0f37-4aa2-4b61-a643-444519206779 51248-151 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20050105 NDA NDA021518 Astellas Pharma Technologies, Inc. SOLIFENACIN SUCCINATE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 51257-640_2bbb3e50-1128-47c2-bd24-1ef0097f04d3 51257-640 HUMAN OTC DRUG Tea Tree Antiseptic Melaleuca Alternifolia OIL TOPICAL 20110201 UNAPPROVED DRUG OTHER Integria Healthcare US Inc. TEA TREE OIL 15 mL/15mL 51257-642_dee2c583-61d1-4b1c-955f-b9319b4e5df4 51257-642 HUMAN OTC DRUG Tea Tree Antiseptic Tea Tree Oil OINTMENT TOPICAL 20130827 UNAPPROVED DRUG OTHER Integria Healthcare (US) Inc TEA TREE OIL 50 mg/g 51257-644_58bedeaa-78d7-4baa-9810-ea7be458dd3c 51257-644 HUMAN OTC DRUG Tea Tree Antiseptic Melaleuca Alternifolia OINTMENT TOPICAL 20110201 UNAPPROVED DRUG OTHER Integria Healthcare US Inc. TEA TREE OIL 2.5 g/50g 51263-3125_4d8dd2ad-f84b-4f4b-92e5-01584491acea 51263-3125 HUMAN OTC DRUG Vanilla Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E MGS Group Limited ALCOHOL 62 mL/100mL 51263-3126_20c43fc8-02ce-4f5a-a9e0-e5f45d93a26a 51263-3126 HUMAN OTC DRUG Unscented Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E MGS Group Limited ALCOHOL 62 mL/100mL 51263-3183_054821b8-3112-4e8e-b72c-84d774df34dc 51263-3183 HUMAN OTC DRUG Sweet Berry Hand Sanitizer Alcohol GEL TOPICAL 20121017 OTC MONOGRAPH FINAL part333E MGS Group Limited ALCOHOL 62 mL/100mL 51263-3184_e2fb5f5b-8051-46df-a689-3967103e927d 51263-3184 HUMAN OTC DRUG Berry Hand Sanitizer with vitamin E and aloe ALCOHOL LIQUID TOPICAL 20140626 OTC MONOGRAPH NOT FINAL part333E MGS Group Limited ALCOHOL 62 mL/100mL 51263-3185_d61c532e-7b3c-4824-88c1-90e137bcf800 51263-3185 HUMAN OTC DRUG Citrus Hand Sanitizer with vitamin E and aloe ALCOHOL LIQUID TOPICAL 20140626 OTC MONOGRAPH NOT FINAL part333E MGS Group Limited ALCOHOL 62 mL/100mL 51263-3186_66a0c859-bfb5-467b-92b6-e7bc3223619a 51263-3186 HUMAN OTC DRUG Fresh Hand Sanitizer with vitamin E and aloe ALCOHOL LIQUID TOPICAL 20140626 OTC MONOGRAPH NOT FINAL part333E MGS Group Limited ALCOHOL 62 mL/100mL 51263-3187_27f80690-b4eb-4e2f-afff-3aecf0758aaa 51263-3187 HUMAN OTC DRUG Vanilla Hand Sanitizer with vitamin E and aloe ALCOHOL LIQUID TOPICAL 20140626 OTC MONOGRAPH NOT FINAL part333E MGS Group Limited ALCOHOL 62 mL/100mL 51270-111_59fa7f73-ed18-4343-a4b3-ef9463cf12b6 51270-111 HUMAN OTC DRUG Hesol Rim SALICYLIC ACID GEL TOPICAL 20101001 UNAPPROVED DRUG OTHER Ecomine Co Ltd NIACINAMIDE; SALICYLIC ACID .6; .3 mL/300mL; mL/300mL 51270-112_027f99c0-4475-41a9-8df0-45d6441e98c3 51270-112 HUMAN OTC DRUG Hesol Rim Tonic SALICYLIC ACID LIQUID TOPICAL 20101001 UNAPPROVED DRUG OTHER Ecomine Co Ltd NIACINAMIDE; SALICYLIC ACID .3; .3 mL/100mL; mL/100mL 51270-113_8f452f90-0479-4dbd-bba7-8a17e02df33f 51270-113 HUMAN OTC DRUG Hesol Rim Jean-Aeck Hair tonic SALICYLIC ACID LIQUID TOPICAL 20101001 UNAPPROVED DRUG OTHER Ecomine Co Ltd NIACINAMIDE; SALICYLIC ACID .3; .5 mL/100mL; mL/100mL 51270-114_663071d3-f615-464a-be61-11bf938d6655 51270-114 HUMAN OTC DRUG Hasol Revitalizing DIMETHICONE GEL TOPICAL 20130701 OTC MONOGRAPH FINAL part347 Ecomine Co Ltd DIMETHICONE 2 g/300g 51270-115_eb3dc411-de86-4805-91ce-5e1f379cc0e9 51270-115 HUMAN OTC DRUG Hasol Revitalizing Treatment DIMETHICONE GEL TOPICAL 20130701 OTC MONOGRAPH FINAL part347 Ecomine Co Ltd DIMETHICONE 1 g/300g 51270-116_cc5615fc-e259-4216-97ce-64454a5df4b8 51270-116 HUMAN OTC DRUG Hasol Revitalizing Scalp Ampoule ALLANTOIN LIQUID TOPICAL 20130701 OTC MONOGRAPH FINAL part347 Ecomine Co Ltd ALLANTOIN .1 g/10g 51270-117_ea9f7f74-d850-48e7-aba1-8e9f9cc305bc 51270-117 HUMAN OTC DRUG Hasol Anti hair loss day tonic Salicylic Acid,Niacinamide LIQUID TOPICAL 20140501 UNAPPROVED DRUG OTHER Ecomine Co., Ltd. NIACINAMIDE; SALICYLIC ACID .225; .375 g/75g; g/75g 51270-118_835404f5-749c-46b7-9486-cb451d9d9d6a 51270-118 HUMAN OTC DRUG denovo 3 H Salicylic Acid,Niacinamide LIQUID TOPICAL 20140501 UNAPPROVED DRUG OTHER Ecomine Co., Ltd. NIACINAMIDE; SALICYLIC ACID .225; .225 g/75g; g/75g 51270-119_64131e37-5f74-444e-8701-656749c4f904 51270-119 HUMAN OTC DRUG HASOL Intensive Salicylic Acid SHAMPOO TOPICAL 20140820 OTC MONOGRAPH FINAL part358H Ecomine Co., Ltd. SALICYLIC ACID .1 1/300mL 51270-120_963df524-a67b-4c57-b310-2d36c9b43e40 51270-120 HUMAN OTC DRUG HASOL Intensive Scalp Tonic Salicylic Acid, Niacinamide, Menthol LIQUID TOPICAL 20140820 UNAPPROVED DRUG OTHER ECOMINE Co., Ltd. MENTHOL; NIACINAMIDE; SALICYLIC ACID .3; .3; .3 1/100mL; 1/100mL; 1/100mL 51270-121_1e6fec35-b789-486e-87d1-41a428cd8c7c 51270-121 HUMAN OTC DRUG Hasol Anti Hair loss day tonic salicylic acid, niacinamide SPRAY TOPICAL 20140727 UNAPPROVED DRUG OTHER Ecomine Co., Ltd. NIACINAMIDE; SALICYLIC ACID .3; .5 1/100mL; 1/100mL 51285-040_fd810568-1ff0-4ccf-a938-403dfd8ee54d 51285-040 HUMAN PRESCRIPTION DRUG Ziac bisoprolol fumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 19930326 NDA NDA020186 Teva Women's Health, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51285-047_fd810568-1ff0-4ccf-a938-403dfd8ee54d 51285-047 HUMAN PRESCRIPTION DRUG Ziac bisoprolol fumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 19930326 NDA NDA020186 Teva Women's Health, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51285-050_fd810568-1ff0-4ccf-a938-403dfd8ee54d 51285-050 HUMAN PRESCRIPTION DRUG Ziac bisoprolol fumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 19930326 NDA NDA020186 Teva Women's Health, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51285-060_dffa820b-820f-4f21-a679-e7bdb047d0bc 51285-060 HUMAN PRESCRIPTION DRUG Zebeta Bisoprolol Fumarate TABLET ORAL 19920731 NDA NDA019982 Duramed Pharmaceuticals, Inc. BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51285-061_dffa820b-820f-4f21-a679-e7bdb047d0bc 51285-061 HUMAN PRESCRIPTION DRUG Zebeta Bisoprolol Fumarate TABLET ORAL 19920731 NDA NDA019982 Duramed Pharmaceuticals, Inc. BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51285-063_f6ba4f9c-4d41-499b-bdc1-c030f84b3a6e 51285-063 HUMAN PRESCRIPTION DRUG Prefest estradiol/norgestimate KIT 20060530 ANDA ANDA076812 Teva Women's Health, Inc. 51285-079_580cdf79-f9a2-47ee-b887-3592f86f82ef 51285-079 HUMAN PRESCRIPTION DRUG LOESTRIN 1/20 21 Day norethindrone acetate and ethinyl estradiol TABLET ORAL 20081001 20151130 ANDA ANDA076380 Teva Women's Health, Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 20; 1 ug/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 51285-080_580cdf79-f9a2-47ee-b887-3592f86f82ef 51285-080 HUMAN PRESCRIPTION DRUG LOESTRIN Fe 1/20 28 Day norethindrone acetate and ethinyl estradiol and ferrous fumarate KIT 20081001 20151130 ANDA ANDA076081 Teva Women's Health, Inc. 51285-081_580cdf79-f9a2-47ee-b887-3592f86f82ef 51285-081 HUMAN PRESCRIPTION DRUG LOESTRIN Fe 1/20 28 Day norethindrone acetate and ethinyl estradiol and ferrous fumarate KIT 20081001 20151130 ANDA ANDA076081 Teva Women's Health, Inc. 51285-082_580cdf79-f9a2-47ee-b887-3592f86f82ef 51285-082 HUMAN PRESCRIPTION DRUG LOESTRIN 1.5/30 21 Day norethindrone acetate and ethinyl estradiol TABLET ORAL 20081001 20151130 ANDA ANDA076381 Teva Women's Health, Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 30; 1.5 ug/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 51285-083_580cdf79-f9a2-47ee-b887-3592f86f82ef 51285-083 HUMAN PRESCRIPTION DRUG LOESTRIN Fe 1.5/30 28 Day norethindrone acetate and ethinyl estradiol and ferrous fumarate KIT 20081001 20151130 ANDA ANDA076064 Teva Women's Health, Inc. 51285-084_580cdf79-f9a2-47ee-b887-3592f86f82ef 51285-084 HUMAN PRESCRIPTION DRUG LOESTRIN Fe 1.5/30 28 Day norethindrone acetate and ethinyl estradiol and ferrous fumarate KIT 20081001 20151130 ANDA ANDA076064 Teva Women's Health, Inc. 51285-087_a42bf77f-3dd5-4164-8f50-064fc6c0a501 51285-087 HUMAN PRESCRIPTION DRUG Seasonique levonorgestrel / ethinyl estradiol and ethinyl estradiol KIT 20060525 NDA NDA021840 Teva Women's Health 51285-092_f8fe52e5-fb64-4af2-9939-e1c623e875af 51285-092 HUMAN PRESCRIPTION DRUG LoSeasonique levonorgestrel/ethinyl estradiol and ethinyl estradiol KIT 20081024 NDA NDA022262 Teva Women's Health, Inc. 51285-100_94f251c1-599c-4517-8c60-50a896b06992 51285-100 HUMAN OTC DRUG Take Action levonorgestrel TABLET ORAL 20140217 NDA AUTHORIZED GENERIC NDA021998 Teva Women's Health, Inc. LEVONORGESTREL 1.5 mg/1 51285-114_716ad3dc-114d-4d75-83da-41987a38fd84 51285-114 HUMAN PRESCRIPTION DRUG Mircette Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol KIT 20090924 20150731 ANDA ANDA075863 Teva Women's Health, Inc. 51285-120_a39bb616-9e84-4142-8450-824f88528906 51285-120 HUMAN PRESCRIPTION DRUG Mircette Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol KIT 20140701 ANDA ANDA075863 Teva Women's Health, Inc. 51285-124_a149f173-fe08-4a1a-b2c4-80670eefea59 51285-124 HUMAN OTC DRUG Plan B One-Step levonorgestrel TABLET ORAL 20131101 NDA NDA021998 Teva Women's Health, Inc. LEVONORGESTREL 1.5 mg/1 51285-125_f29ebcb5-7e65-4092-bfaa-f5ec026fc255 51285-125 HUMAN PRESCRIPTION DRUG LOESTRIN Fe 1/20 28 Day Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate KIT 20140630 ANDA ANDA076081 Teva Women's Health, Inc. 51285-126_f29ebcb5-7e65-4092-bfaa-f5ec026fc255 51285-126 HUMAN PRESCRIPTION DRUG LOESTRIN Fe 1/20 28 Day Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate KIT 20140630 ANDA ANDA076081 Teva Women's Health, Inc. 51285-127_f29ebcb5-7e65-4092-bfaa-f5ec026fc255 51285-127 HUMAN PRESCRIPTION DRUG LOESTRIN 21 1.5/30 21 Day Norethindrone Acetate/Ethinyl Estradiol TABLET ORAL 20140630 ANDA ANDA076381 Teva Women's Health, Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE .03; 1.5 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 51285-128_f29ebcb5-7e65-4092-bfaa-f5ec026fc255 51285-128 HUMAN PRESCRIPTION DRUG LOESTRIN Fe 1.5/30 28 Day Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate KIT 20140630 ANDA ANDA076064 Teva Women's Health, Inc. 51285-129_f29ebcb5-7e65-4092-bfaa-f5ec026fc255 51285-129 HUMAN PRESCRIPTION DRUG LOESTRIN Fe 1.5/30 28 Day Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate KIT 20140630 ANDA ANDA076064 Teva Women's Health, Inc. 51285-131_f29ebcb5-7e65-4092-bfaa-f5ec026fc255 51285-131 HUMAN PRESCRIPTION DRUG LOESTRIN 21 1/20 21 Day Norethindrone Acetate/Ethinyl Estradiol TABLET ORAL 20140630 ANDA ANDA076380 Teva Women's Health, Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE .02; 1 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 51285-138_40be36a7-4b70-4a2c-b74c-30206330509e 51285-138 VACCINE Adenovirus Type 4 and Type 7 Vaccine, Live Adenovirus Type 4 and Type 7 Vaccine, Live KIT 20110916 BLA BLA125296 Teva Women's Health, Inc. 51285-146_a149f173-fe08-4a1a-b2c4-80670eefea59 51285-146 HUMAN OTC DRUG Plan B One-Step levonorgestrel TABLET ORAL 20131212 NDA NDA021998 Teva Women's Health, Inc. LEVONORGESTREL 1.5 mg/1 51285-162_bbca2448-8454-4162-b907-a1cd98ea00e0 51285-162 HUMAN OTC DRUG Plan B One-Step levonorgestrel TABLET ORAL 20130826 NDA NDA021998 Teva Women's Health, Inc. LEVONORGESTREL 1.5 mg/1 51285-204_f9ca4370-5d34-4473-a431-1615a10bdf37 51285-204 HUMAN PRESCRIPTION DRUG ParaGard T 380A copper INTRAUTERINE DEVICE INTRAUTERINE 20040101 NDA NDA018680 Teva Women's Health, Inc. COPPER 313.4 mg/1 Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 51285-275_ae904573-9e40-4533-bca3-9983a85368cc 51285-275 HUMAN PRESCRIPTION DRUG REVIA Naltrexone Hydrochloride TABLET, FILM COATED ORAL 20030718 ANDA ANDA074918 Teva Women's Health, Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] 51285-366_f20394b6-81a4-4fe2-bc7b-ad88e2c8915b 51285-366 HUMAN PRESCRIPTION DRUG Trexall methotrexate TABLET, FILM COATED ORAL 20010503 ANDA ANDA040385 Teva Women's Health, Inc. METHOTREXATE SODIUM 5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 51285-367_f20394b6-81a4-4fe2-bc7b-ad88e2c8915b 51285-367 HUMAN PRESCRIPTION DRUG Trexall methotrexate TABLET, FILM COATED ORAL 20010503 ANDA ANDA040385 Teva Women's Health, Inc. METHOTREXATE SODIUM 7.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 51285-368_f20394b6-81a4-4fe2-bc7b-ad88e2c8915b 51285-368 HUMAN PRESCRIPTION DRUG Trexall methotrexate TABLET, FILM COATED ORAL 20010503 ANDA ANDA040385 Teva Women's Health, Inc. METHOTREXATE SODIUM 10 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 51285-369_f20394b6-81a4-4fe2-bc7b-ad88e2c8915b 51285-369 HUMAN PRESCRIPTION DRUG Trexall methotrexate TABLET, FILM COATED ORAL 20010503 ANDA ANDA040385 Teva Women's Health, Inc. METHOTREXATE SODIUM 15 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 51285-406_b7aba0b2-72d1-4429-bb64-98b92e9d9433 51285-406 HUMAN PRESCRIPTION DRUG ENJUVIA synthetic conjugated estrogens, B TABLET ORAL 20040510 NDA NDA021443 Duramed Pharmaceuticals Inc. ESTROGENS, CONJUGATED SYNTHETIC B .3 mg/1 51285-407_b7aba0b2-72d1-4429-bb64-98b92e9d9433 51285-407 HUMAN PRESCRIPTION DRUG ENJUVIA synthetic conjugated estrogens, B TABLET ORAL 20040510 NDA NDA021443 Duramed Pharmaceuticals Inc. ESTROGENS, CONJUGATED SYNTHETIC B .45 mg/1 51285-408_b7aba0b2-72d1-4429-bb64-98b92e9d9433 51285-408 HUMAN PRESCRIPTION DRUG ENJUVIA synthetic conjugated estrogens, B TABLET ORAL 20040510 NDA NDA021443 Duramed Pharmaceuticals Inc. ESTROGENS, CONJUGATED SYNTHETIC B .625 mg/1 51285-409_b7aba0b2-72d1-4429-bb64-98b92e9d9433 51285-409 HUMAN PRESCRIPTION DRUG ENJUVIA synthetic conjugated estrogens, B TABLET ORAL 20040510 NDA NDA021443 Duramed Pharmaceuticals Inc. ESTROGENS, CONJUGATED SYNTHETIC B .9 mg/1 51285-410_b7aba0b2-72d1-4429-bb64-98b92e9d9433 51285-410 HUMAN PRESCRIPTION DRUG ENJUVIA synthetic conjugated estrogens, B TABLET ORAL 20040510 NDA NDA021443 Duramed Pharmaceuticals Inc. ESTROGENS, CONJUGATED SYNTHETIC B 1.25 mg/1 51285-424_c4915e0d-bd24-4166-8078-c1e8e9978c12 51285-424 HUMAN PRESCRIPTION DRUG Aygestin Norethindrone Acetate TABLET ORAL 20030612 ANDA ANDA075951 Teva Women's Health, Inc. NORETHINDRONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 51285-431_99c669d8-12ef-4d3a-8761-02d5acb0c8b0 51285-431 HUMAN PRESCRIPTION DRUG QUARTETTE levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets KIT 20130329 NDA NDA204061 Teva Women's Health, Inc. 51285-441_d0b48218-7c28-455a-998e-a47e9f5315f7 51285-441 HUMAN PRESCRIPTION DRUG Cenestin Synthetic Conjugated Estrogens, A TABLET, FILM COATED ORAL 20020805 20160430 NDA NDA020992 Teva Women's Health, Inc. ESTROGENS, CONJUGATED SYNTHETIC A .3 mg/1 51285-442_d0b48218-7c28-455a-998e-a47e9f5315f7 51285-442 HUMAN PRESCRIPTION DRUG Cenestin Synthetic Conjugated Estrogens, A TABLET, FILM COATED ORAL 19990512 20160430 NDA NDA020992 Teva Women's Health, Inc. ESTROGENS, CONJUGATED SYNTHETIC A .625 mg/1 51285-443_d0b48218-7c28-455a-998e-a47e9f5315f7 51285-443 HUMAN PRESCRIPTION DRUG Cenestin Synthetic Conjugated Estrogens, A TABLET, FILM COATED ORAL 19990512 20160430 NDA NDA020992 Teva Women's Health, Inc. ESTROGENS, CONJUGATED SYNTHETIC A .9 mg/1 51285-444_d0b48218-7c28-455a-998e-a47e9f5315f7 51285-444 HUMAN PRESCRIPTION DRUG Cenestin Synthetic Conjugated Estrogens, A TABLET, FILM COATED ORAL 20000320 20160430 NDA NDA020992 Teva Women's Health, Inc. ESTROGENS, CONJUGATED SYNTHETIC A 1.25 mg/1 51285-446_d0b48218-7c28-455a-998e-a47e9f5315f7 51285-446 HUMAN PRESCRIPTION DRUG Cenestin Synthetic Conjugated Estrogens, A TABLET, FILM COATED ORAL 20040401 20150430 NDA NDA020992 Teva Women's Health, Inc. ESTROGENS, CONJUGATED SYNTHETIC A .45 mg/1 51285-523_b236498a-d8ea-44e1-9f3e-f0afcb24fa86 51285-523 HUMAN PRESCRIPTION DRUG Antabuse Disulfiram TABLET ORAL 20001201 ANDA ANDA088482 Teva Women's Health, Inc. DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] 51285-524_b236498a-d8ea-44e1-9f3e-f0afcb24fa86 51285-524 HUMAN PRESCRIPTION DRUG Antabuse Disulfiram TABLET ORAL 20060201 ANDA ANDA088483 Teva Women's Health, Inc. DISULFIRAM 500 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] 51285-538_9d9183a8-11ee-4cdc-9ff6-5e8f0f92f3c4 51285-538 HUMAN PRESCRIPTION DRUG Surmontil Trimipramine Maleate CAPSULE ORAL 19900930 NDA NDA016792 Teva Women's Health, Inc. TRIMIPRAMINE MALEATE 25 mg/1 Tricyclic Antidepressant [EPC] 51285-539_9d9183a8-11ee-4cdc-9ff6-5e8f0f92f3c4 51285-539 HUMAN PRESCRIPTION DRUG Surmontil Trimipramine Maleate CAPSULE ORAL 19900930 NDA NDA016792 Teva Women's Health, Inc. TRIMIPRAMINE MALEATE 50 mg/1 Tricyclic Antidepressant [EPC] 51285-554_9d9183a8-11ee-4cdc-9ff6-5e8f0f92f3c4 51285-554 HUMAN PRESCRIPTION DRUG Surmontil Trimipramine Maleate CAPSULE ORAL 19900930 NDA NDA016792 Teva Women's Health, Inc. TRIMIPRAMINE MALEATE 100 mg/1 Tricyclic Antidepressant [EPC] 51285-594_b3ae92e4-a644-4b9f-a048-ea1c82c0f025 51285-594 HUMAN PRESCRIPTION DRUG Vivactil Protriptyline Hydrochloride TABLET, FILM COATED ORAL 20001101 ANDA ANDA073645 Teva Women's Health, Inc. PROTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 51285-595_b3ae92e4-a644-4b9f-a048-ea1c82c0f025 51285-595 HUMAN PRESCRIPTION DRUG Vivactil Protriptyline Hydrochloride TABLET, FILM COATED ORAL 20001101 ANDA ANDA073644 Teva Women's Health, Inc. PROTRIPTYLINE HYDROCHLORIDE 5 mg/1 Tricyclic Antidepressant [EPC] 51285-690_57bdaaf9-fd4a-4d1c-afa6-7aa3c6828dfa 51285-690 HUMAN PRESCRIPTION DRUG Urecholine Bethanechol Chloride TABLET ORAL 20010201 ANDA ANDA088440 Teva Women's Health, Inc. BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 51285-691_57bdaaf9-fd4a-4d1c-afa6-7aa3c6828dfa 51285-691 HUMAN PRESCRIPTION DRUG Urecholine Bethanechol Chloride TABLET ORAL 20000401 ANDA ANDA088441 Teva Women's Health, Inc. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 51285-692_57bdaaf9-fd4a-4d1c-afa6-7aa3c6828dfa 51285-692 HUMAN PRESCRIPTION DRUG Urecholine Bethanechol Chloride TABLET ORAL 20010201 ANDA ANDA089096 Teva Women's Health, Inc. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 51285-697_57bdaaf9-fd4a-4d1c-afa6-7aa3c6828dfa 51285-697 HUMAN PRESCRIPTION DRUG Urecholine Bethanechol Chloride TABLET ORAL 20010201 ANDA ANDA089095 Teva Women's Health, Inc. BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 51285-754_83da6c1d-bb8e-430a-87fe-93b4bc22420d 51285-754 HUMAN PRESCRIPTION DRUG Diamox Sequels Acetazolamide CAPSULE, EXTENDED RELEASE ORAL 19620301 NDA NDA012945 Duramed Pharmaceuticals, Inc. ACETAZOLAMIDE 500 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 51285-942_65e9d8fa-10f2-45c6-bd05-e95450c914a8 51285-942 HUMAN PRESCRIPTION DRUG Plan B One-Step levonorgestrel TABLET ORAL 20090728 20160930 NDA NDA021998 Teva Women's Health, Inc. LEVONORGESTREL 1.5 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 51285-943_67519d58-3733-46b1-be74-7cb490d476e5 51285-943 HUMAN OTC DRUG Plan B One-Step levonorgestrel TABLET ORAL 20130708 20160930 NDA NDA021998 Teva Women's Health, Inc. LEVONORGESTREL 1.5 mg/1 51285-963_65e9d8fa-10f2-45c6-bd05-e95450c914a8 51285-963 HUMAN PRESCRIPTION DRUG Plan B One-Step levonorgestrel TABLET ORAL 20090914 20160430 NDA NDA021998 Teva Women's Health, Inc. LEVONORGESTREL 1.5 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 51289-100_728deb34-df4e-44f6-b9b7-4c4f4968ee40 51289-100 HUMAN OTC DRUG Rain Breeze Toothpaste SODIUM FLUORIDE PASTE DENTAL 20100821 OTC MONOGRAPH FINAL part355 Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd. SODIUM FLUORIDE .22 g/100g 51289-200_0bd50eca-83a5-4c15-95e7-460e07cd8779 51289-200 HUMAN OTC DRUG Charm Tex Fluoride SODIUM FLUORIDE PASTE DENTAL 20130710 OTC MONOGRAPH FINAL part355 Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 51290-011_6b58da56-8aba-4b5a-8d23-f026a9715f32 51290-011 HUMAN OTC DRUG Medaclear zinc pyrithione SHAMPOO TOPICAL 20100908 OTC MONOGRAPH FINAL part358H Amico Educational Concepts, Inc. PYRITHIONE ZINC 15 g/L 51293-605_23eeca2c-6fb7-4f12-b18d-3c4ef3fb7419 51293-605 HUMAN PRESCRIPTION DRUG ISOXSUPRINE HYDROCHLORIDE isoxsuprine hydrochloride TABLET ORAL 20110823 UNAPPROVED DRUG OTHER ECI Pharmaceuticals LLC ISOXSUPRINE HYDROCHLORIDE 20 mg/1 51293-606_23eeca2c-6fb7-4f12-b18d-3c4ef3fb7419 51293-606 HUMAN PRESCRIPTION DRUG ISOXSUPRINE HYDROCHLORIDE isoxsuprine hydrochloride TABLET ORAL 20110602 UNAPPROVED DRUG OTHER ECI Pharmaceuticals LLC ISOXSUPRINE HYDROCHLORIDE 10 mg/1 51293-607_e07f1952-02ac-4cd9-a9ae-e5434bb462bc 51293-607 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride and Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20110504 UNAPPROVED DRUG OTHER ECI Pharmaceuticals LLC CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] 51293-611_d0334d89-6721-49c4-a862-8a7dd75c03d5 51293-611 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110823 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 51293-612_d0334d89-6721-49c4-a862-8a7dd75c03d5 51293-612 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110823 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 51293-617_8f5619e8-d9d7-414b-8eb2-365178080f1e 51293-617 HUMAN PRESCRIPTION DRUG Isometheptene Mucate/Dichloralphenazone/Acetaminophen ISOMETHEPTENE MUCATE, DICHLORALPHENAZONE, and ACETAMINOPHEN CAPSULE ORAL 20110215 UNAPPROVED DRUG OTHER ECI Pharmaceuticals LLC ACETAMINOPHEN; DICHLORALPHENAZONE; ISOMETHEPTENE MUCATE 325; 100; 65 mg/1; mg/1; mg/1 CIV 51293-622_6f82b2b0-23e7-47e1-b65f-98ded8fd47d4 51293-622 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride and Promethazine Hydrochloride Meperidine Hydrochloride and Promethazine Hydrochloride CAPSULE ORAL 20130219 UNAPPROVED DRUG OTHER ECI Pharmaceuticals LLC MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 50; 25 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CII 51293-625_0810780e-0fb8-04da-e054-00144ff8d46c 51293-625 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20141124 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENOBARBITAL 16.2 mg/1 CIV 51293-626_0810780e-0fb8-04da-e054-00144ff8d46c 51293-626 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20141124 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENOBARBITAL 32.4 mg/1 CIV 51293-627_0810780e-0fb8-04da-e054-00144ff8d46c 51293-627 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20141124 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENOBARBITAL 64.8 mg/1 CIV 51293-628_0810780e-0fb8-04da-e054-00144ff8d46c 51293-628 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20141124 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENOBARBITAL 97.2 mg/1 CIV 51293-801_6ec64d33-6f0c-4b44-b23a-ec06e912dd8d 51293-801 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 51293-802_6ec64d33-6f0c-4b44-b23a-ec06e912dd8d 51293-802 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 51293-803_188482df-1e2f-4685-bbc1-7f4ccd16ef29 51293-803 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20141001 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC SALSALATE 500 mg/1 51293-804_188482df-1e2f-4685-bbc1-7f4ccd16ef29 51293-804 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20141001 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC SALSALATE 750 mg/1 51312-065_caab51b5-7536-4a0f-8f74-4b4f091cf4c7 51312-065 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 20100915 UNAPPROVED MEDICAL GAS AmMed, Inc. OXYGEN 995 mL/100L 51325-100_2cd3a7e4-1a01-465c-a413-609709103087 51325-100 HUMAN OTC DRUG Rejuvaderm Medispa sunscreen Octinoxate, Octisalate, Zinc oxide LOTION TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part352 Ellen H Frankle MD Inc OCTINOXATE; OCTISALATE; ZINC OXIDE 9; 2.4; 9 mL/120mL; mL/120mL; mL/120mL 51325-200_656a38b5-c598-4e10-995e-4bdbd5057e12 51325-200 HUMAN OTC DRUG Rejuvaderm Medispa Body Octinoxate, octisalate, oxybenzone LOTION TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part352 Ellen H Frankle MD Inc OCTINOXATE; OCTISALATE; OXYBENZONE 26.625; 17.75; 10.65 mL/355mL; mL/355mL; mL/355mL 51325-300_d4552d19-6285-4d4f-bee0-4d18b4fd1001 51325-300 HUMAN OTC DRUG Rejuvaderm medispa fading hydroquinone LOTION TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part358A Ellen H Frankle MD Inc HYDROQUINONE 1.2 mL/60mL 51325-400_6f861083-6259-47ff-b8b9-6c74f32dd10c 51325-400 HUMAN OTC DRUG Rejuvaderm MediSpa Acne Back Salicylic acid SPRAY TOPICAL 20100720 OTC MONOGRAPH FINAL part333D Ellen Frankle MD Inc. SALICYLIC ACID 4.8 mL/240mL 51327-100_50a8980f-d0b7-4723-8195-ad98749e96a3 51327-100 HUMAN OTC DRUG Fusion Beauty ColorCeuticals Acne Control Primer SALICYLIC ACID LOTION TOPICAL 20100728 OTC MONOGRAPH FINAL part333 Fusion Brands SALICYLIC ACID .5 mL/100mL 51327-200_74f2b8c5-2c88-4856-8b45-cd30ad22e900 51327-200 HUMAN OTC DRUG FusionBeauty Colorceuticals PrimeResults Tinted Moisturizer SPF15 Caramel OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20101108 OTC MONOGRAPH FINAL part352 Fusion Brands OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 6; 4; 2.7 mL/100mL; mL/100mL; mL/100mL 51327-210_0852f62b-d2c6-46f4-b5b7-1228e6fae0ff 51327-210 HUMAN OTC DRUG Primer Results Tinted Moisturizer SPF15 Caramel OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20101108 OTC MONOGRAPH FINAL part352 Fusion Brands OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 6; 4; 2.7 mL/100mL; mL/100mL; mL/100mL 51327-300_3dc13240-2173-45e7-9fcf-f1dffacaf821 51327-300 HUMAN OTC DRUG FusionBeauty Colorceuticals PrimeResults Tinted Moisturizer SPF15 Golden Beige OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20101108 OTC MONOGRAPH FINAL part352 Fusion Brands OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 6; 4; 2.7 mL/100mL; mL/100mL; mL/100mL 51327-310_104c19f9-49fe-44c6-b79e-45bd337de1c6 51327-310 HUMAN OTC DRUG Primer Results Tinted Moisturizer SPF15 Golden Beige OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20101108 OTC MONOGRAPH FINAL part352 Fusion Brands OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 6; 4; 2.7 mL/100mL; mL/100mL; mL/100mL 51327-400_7817b891-48ef-48b0-9e6c-f3d25001ba4d 51327-400 HUMAN OTC DRUG FusionBeauty Colorceuticals PrimeResults Tinted Moisturizer SPF15 Ivory OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20101108 OTC MONOGRAPH FINAL part352 Fusion Brands OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 6; 4; 2.7 mL/100mL; mL/100mL; mL/100mL 51327-410_b3cda854-e9ab-43db-aaca-53ce178c0421 51327-410 HUMAN OTC DRUG Primer Results Tinted Moisturizer SPF15 Ivory OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20101108 OTC MONOGRAPH FINAL part352 Fusion Brands OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 6; 4; 2.7 mL/100mL; mL/100mL; mL/100mL 51327-500_3c4d2ac4-9c84-42e8-ab14-0cad2cd0889e 51327-500 HUMAN OTC DRUG FusionBeauty Colorceuticals PrimeResults Tinted Moisturizer SPF15 Sand OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20101108 OTC MONOGRAPH FINAL part352 Fusion Brands OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 6; 4; 2.7 mL/100mL; mL/100mL; mL/100mL 51327-510_4d40da0a-9948-43bb-9353-ff7f0a5c4525 51327-510 HUMAN OTC DRUG Primer Results Tinted Moisturizer SPF15 Sand OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20101108 OTC MONOGRAPH FINAL part352 Fusion Brands OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 6; 4; 2.7 mL/100mL; mL/100mL; mL/100mL 51329-1001_8655b9fe-b324-4da2-8a5e-c19ad843fb7e 51329-1001 HUMAN OTC DRUG Doll Lash Zinc pyrithione LIQUID TOPICAL 20101106 UNAPPROVED DRUG OTHER Hanbit Korea BIOTIN; NIACINAMIDE; PANTHENOL; PYRITHIONE ZINC .06; .3; .5; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 51329-2001_beccee7d-5f1e-4988-a540-f0bc35c48ebc 51329-2001 HUMAN OTC DRUG derma MOBALNA EP 90 Hair Again Toner ACORUS CALAMUS ROOT LIQUID TOPICAL 20140330 UNAPPROVED DRUG OTHER Hanbit Korea ACORUS CALAMUS ROOT .15 g/mL 51334-0001_134e7720-1441-4aaa-aafa-beba6f9aaa24 51334-0001 HUMAN OTC DRUG Toys-R-Us Babies-R-Us Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110520 OTC MONOGRAPH NOT FINAL part333E Toys-R-Us ALCOHOL 62 mL/100mL 51334-0002_5b066290-c83b-4bb5-92af-a91ffaa93fe3 51334-0002 HUMAN OTC DRUG Toys-R-Us Babies-R-Us Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20120423 OTC MONOGRAPH NOT FINAL part333E Toys-R-Us ALCOHOL 62 mL/100mL 51334-008_c5326784-97f0-42c7-8c32-238f72764b75 51334-008 HUMAN OTC DRUG babies r us infants pain relief Acetaminophen SUSPENSION/ DROPS ORAL 20101201 OTC MONOGRAPH NOT FINAL part343 Toys"R"Us, Inc. ACETAMINOPHEN 80 mg/.8mL 51334-130_3269bd54-151d-4faa-9244-b3cf2eb9cfe7 51334-130 HUMAN OTC DRUG babies r us childrens pain relief Acetaminophen SUSPENSION ORAL 20101201 OTC MONOGRAPH NOT FINAL part343 Toys"R"Us, Inc. ACETAMINOPHEN 160 mg/5mL 51334-161_38bc798e-4ed9-41fb-a51a-5706b36a60f4 51334-161 HUMAN OTC DRUG Babies R Us Pain and Fever Acetaminophen LIQUID ORAL 20111129 OTC MONOGRAPH NOT FINAL part343 Toys"R"Us, Inc. ACETAMINOPHEN 160 mg/5mL 51334-255_498bab2c-c14d-4a98-88d9-fa0f9b239832 51334-255 HUMAN OTC DRUG babies r us infants ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20101201 ANDA ANDA075217 Toys"R"Us, Inc. IBUPROFEN 50 mg/1.25mL 51334-289_6706606e-30b9-4a0a-a721-1bccd870faf3 51334-289 HUMAN OTC DRUG babies r us pain relief Acetaminophen SUSPENSION/ DROPS ORAL 20101210 OTC MONOGRAPH NOT FINAL part343 Toys"R"Us, Inc. ACETAMINOPHEN 80 mg/.8mL 51334-590_05a37320-bfd5-4591-8081-555435963837 51334-590 HUMAN OTC DRUG babies r us infants pain and fever acetaminophen LIQUID ORAL 20111104 OTC MONOGRAPH NOT FINAL part343 Toys"R"Us, Inc. ACETAMINOPHEN 160 mg/5mL 51334-882_cb8770ca-73bb-438a-88c5-65e0c326bfa2 51334-882 HUMAN OTC DRUG babies r us gas relief infants Simethicone EMULSION ORAL 20110216 OTC MONOGRAPH FINAL part332 Toys"R"Us, Inc. DIMETHICONE 20 mg/.3mL 51334-897_5c648b59-3200-4162-9c11-fb355592c417 51334-897 HUMAN OTC DRUG babies r us ibuprofen Ibuprofen SUSPENSION ORAL 20101201 ANDA ANDA074937 Toys"R"Us, Inc. IBUPROFEN 100 mg/5mL 51334-946_89d27969-93e1-4ec1-9e13-4f54e2966629 51334-946 HUMAN OTC DRUG babies r us infants pain and fever Acetaminophen LIQUID ORAL 20111129 OTC MONOGRAPH NOT FINAL part343 Toys"R"Us, Inc. ACETAMINOPHEN 160 mg/5mL 51334-980_92c96552-1a42-4245-aaf8-1ff485711ab4 51334-980 HUMAN OTC DRUG babies r us infants pain relief Acetaminophen SUSPENSION/ DROPS ORAL 20110311 OTC MONOGRAPH NOT FINAL part343 Toys"R"Us, Inc. ACETAMINOPHEN 80 mg/.8mL 51335-001_6a090b5c-1f12-45f7-b056-c87b2fe1aacb 51335-001 HUMAN OTC DRUG Instant Hand Sanitizer with Moisturizers Unscented ALCOHOL LIQUID TOPICAL 20100809 OTC MONOGRAPH NOT FINAL part333E Ningbo Heyi Daily Chemical Products Co., Ltd. ALCOHOL 62 g/100g 51335-002_1e9f45b6-1729-4635-b76f-38cc67dd54e3 51335-002 HUMAN OTC DRUG Instant Hand Sanitizer with Moisturizers Aloe Scented ALCOHOL LIQUID TOPICAL 20100809 OTC MONOGRAPH NOT FINAL part333E Ningbo Heyi Daily Chemical Products Co., Ltd. ALCOHOL 62 g/100g 51335-003_e9f53328-2f3c-4676-8f65-498026101313 51335-003 HUMAN OTC DRUG Instant Hand Sanitizer with Moisturizers Ocean Scented ALCOHOL LIQUID TOPICAL 20100809 OTC MONOGRAPH NOT FINAL part333E Ningbo Heyi Daily Chemical Products Co., Ltd. ALCOHOL 62 g/100g 51335-004_fb52380c-e6be-4818-8566-ac7d4470e504 51335-004 HUMAN OTC DRUG Instant Hand Sanitizer Green Apple Scented ALCOHOL LIQUID TOPICAL 20120802 OTC MONOGRAPH NOT FINAL part333E Ningbo Heyi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL 51335-005_13b816bb-7336-44af-973e-be95d37d6238 51335-005 HUMAN OTC DRUG Instant Hand Sanitizer Fresh Lemon Scented ALCOHOL LIQUID TOPICAL 20120803 OTC MONOGRAPH NOT FINAL part333E Ningbo Heyi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL 51335-006_8cc943f9-8bec-42cb-920a-61aaf9b22a8f 51335-006 HUMAN OTC DRUG Instant Hand Sanitizer Strawberry Scented ALCOHOL LIQUID TOPICAL 20120803 OTC MONOGRAPH NOT FINAL part333E Ningbo Heyi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL 51345-050_d56c70a3-1bbb-499f-be87-6397fc967af7 51345-050 HUMAN OTC DRUG Exotic Cherry Blossom Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20110407 OTC MONOGRAPH FINAL part333E Advanced Beauty Systems, Inc. ALCOHOL 70 mL/100mL 51345-051_278d4d09-b807-40ce-a912-4e79f043e4b3 51345-051 HUMAN OTC DRUG Enchanted Forest Hand Sanitizer Bodycology Ethyl Alcohol LIQUID TOPICAL 20110407 OTC MONOGRAPH FINAL part333E Advanced Beauty Systems, Inc. ALCOHOL 22.5 mL/30mL 51345-052_4092f88b-7fb2-4db1-a0e0-cff56a4930f2 51345-052 HUMAN OTC DRUG Fresh Cucumber Melon Bodycology Ethyl Alcohol LIQUID TOPICAL 20110407 OTC MONOGRAPH FINAL part333E Advanced Beauty Systems, Inc. ALCOHOL 22.5 mL/30mL 51345-053_77dc19cd-d3c9-4e32-b3ea-b602dbe6c847 51345-053 HUMAN OTC DRUG Bodycology Exotic Cherry Blossom Kit Exotic Cherry Blossom KIT 20120630 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. 51345-055_506a9281-832b-4ff0-8d65-351b4ac68a31 51345-055 HUMAN OTC DRUG Bodycology Enchanted Forest Kit Enchanted Forest KIT 20120630 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. 51345-057_81a63de1-72c5-4b34-b677-b535b14f03b6 51345-057 HUMAN OTC DRUG Bodycology Toasted Vanilla Kit Toasted Vanilla KIT 20120630 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. 51345-059_106c1f98-de29-457b-9432-ddf5a766c645 51345-059 HUMAN OTC DRUG Bodycology Fresh Cucumber Kit Fresh Cucumber KIT 20120630 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. 51345-061_8626b5c7-82c0-4d38-a692-4fe1eb7189d7 51345-061 HUMAN OTC DRUG Bodycology Enchanted Forest Kit Enchanted Forest KIT 20120803 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. 51345-063_dde66f79-13bf-4681-9aee-f15062101b3f 51345-063 HUMAN OTC DRUG Bodycology Exotic Cherry Kit Exotic Cherry KIT 20120803 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. 51345-065_e28b6e69-9d22-43e3-90aa-04d2a069d2ef 51345-065 HUMAN OTC DRUG Bodycology Toasted Vanilla Sugar Kit Toasted Vanilla Sugar KIT 20120803 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. 51345-067_0d35f0e1-4acf-4493-b620-22d7e1a4276b 51345-067 HUMAN OTC DRUG Bodycology Fresh Cucumber Melon Kit Fresh Cucumber Melon KIT 20120803 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. 51345-099_2cda2490-12e0-4b87-8c8e-7e7807bf5aa4 51345-099 HUMAN OTC DRUG Epsom Salt Soaking Solution Magnesium Sulfate GRANULE TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part334 Advanced Beauty Systems, Inc. MAGNESIUM SULFATE 2.72 kg/2.72kg 51345-105_222b38c2-2c4b-4cff-b78c-6367d1ac3e04 51345-105 HUMAN OTC DRUG Toasted Vanilla Sugar Hand Sanitizer Bodycology Ethyl Alcohol LIQUID TOPICAL 20110407 OTC MONOGRAPH FINAL part333E Advanced Beauty Systems, Inc. ALCOHOL 22.5 mL/30mL 51345-106_18987b4b-8c63-4d24-b1f7-5de17ea58614 51345-106 HUMAN OTC DRUG Dr Teals Triple Antibiotic Bactracin, Neomycin, Polymyxin B OINTMENT TOPICAL 20120806 OTC MONOGRAPH FINAL part333B Advanced Beauty Systems, Inc. BACITRACIN; NEOMYCIN; POLYMYXIN B 400; 3.5; 5000 U/28g; mg/28g; U/28g 51345-107_c7f1e948-8b66-4cda-941d-0ae56f78c668 51345-107 HUMAN OTC DRUG exotic cherry blossom kit bodycology alcohol KIT 20130624 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. 51345-109_731cf7e3-ed44-452e-8cbd-f4f60751370a 51345-109 HUMAN OTC DRUG Toasted Vanilla Sugar Kit Bodycology alcohol KIT 20130625 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. 51345-111_abdaec0e-aac3-4b79-a9be-8e1efd491cc6 51345-111 HUMAN OTC DRUG XOXO Kit bodycology alcohol KIT 20130627 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. 51345-113_bf6f70e5-984d-4758-937d-8d9205628cae 51345-113 HUMAN OTC DRUG Exotic Cherry Blossom Kit bodycology alcohol KIT 20130625 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. 51345-115_8be95fb2-2780-4b7b-a95a-83dd035d0178 51345-115 HUMAN OTC DRUG Toasted Vanilla Kit Bodycology alcohol KIT 20130625 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. 51345-117_7639d1fa-8425-492c-8e50-ef70307b6e6d 51345-117 HUMAN OTC DRUG XOXO Kit Bodycology alcohol KIT 20130626 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. 51345-119_681a849f-c307-479b-bfd2-b5a9b627f357 51345-119 HUMAN OTC DRUG Pretty in Paris Kit Bodycology alcohol KIT 20130627 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. 51346-001_eba63df1-32eb-4b62-95a2-995fb5973663 51346-001 HUMAN OTC DRUG THE FIRST SUN SPF50 PLUS PA PLUS PLUS PLUS OCTINOXATE, ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE LIQUID TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 2; 1; 2.61 g/40mL; g/40mL; g/40mL; g/40mL 51346-002_b34a61e2-b721-44c3-833b-df2ca232f67d 51346-002 HUMAN OTC DRUG TRUFFLE EX SUN SPF50 PLUS PA PLUS PLUS PLUS OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 3.75; 2.5; 1.25; 2.4 g/50mL; g/50mL; g/50mL; g/50mL 51346-003_cce26f54-e124-40b9-866e-68e81953e663 51346-003 HUMAN OTC DRUG THE FIRST FERMENTED ESSENCE BB BALM SPF25 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .36; .24; .96 g/12g; g/12g; g/12g 51346-004_1a708632-3dcb-4760-b468-b9340a676a57 51346-004 HUMAN OTC DRUG BERRY BABY LIP BALM RED BERRY SPF12 OCTINOXATE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE .6 g/12g 51346-005_65425705-4fed-4415-9875-47308800a4c1 51346-005 HUMAN OTC DRUG BERRY BABY LIP BALM PEACH BERRY SPF12 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .6; .048 g/12g; g/12g 51346-006_b364cf89-cb2f-4a7d-b674-86cd0b180cd2 51346-006 HUMAN OTC DRUG BERRY BABY LIP BALM VIOLET BERRY SPF12 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .6; .012 g/12g; g/12g 51346-007_03f258f7-d572-43b3-99a4-aef63b20ae12 51346-007 HUMAN OTC DRUG COLLAGEN HD FOUNDATION SPF30 PA PLUS PLUS 21 SOFT BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; 3.16; .76 g/40mL; g/40mL; g/40mL 51346-008_30766a8d-43f4-4b4e-b978-c43a575fbf0b 51346-008 HUMAN OTC DRUG COLLAGEN HD MAKE UP BASE SPF30 PA PLUS PLUS 01 GREEN OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 2.4; 1.6 g/40mL; g/40mL 51346-009_9e06f457-58ff-40cb-9fa2-18238c0ec20e 51346-009 HUMAN OTC DRUG COLLAGEN HD MAKE UP BASE SPF30 PA PLUS PLUS 02 VIOLET OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.4; 1.6; .76 g/40mL; g/40mL; g/40mL 51346-010_9d375f59-af8e-4dc1-9a88-4bcb88774ebb 51346-010 HUMAN OTC DRUG BOTANICAL VANILLA SPF25 PA PLUS 01 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .5; 1.55; .475 g/25g; g/25g; g/25g 51346-011_551d984d-9f85-4438-82d0-8e5878e04254 51346-011 HUMAN OTC DRUG BOTANICAL VANILLA SPF25 PA PLUS 02 VANILLA PINK TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .5; 1.525; .475 g/25g; g/25g; g/25g 51346-012_3026d217-27e3-40d9-ae53-6324af865680 51346-012 HUMAN OTC DRUG BOTANICAL VANILLA PACT SPF30 PA PLUS PLUS PLUS 21 VANILLA NUDE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .55; 1.111; .319 g/11g; g/11g; g/11g 51346-013_898e77e5-ea89-43c7-ad74-f438ea2dd0be 51346-013 HUMAN OTC DRUG BOTANICAL VANILLA PACT SPF30 PA PLUS PLUS PLUS VANILLA NATURAL TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .55; 1.111; .319 g/11g; g/11g; g/11g 51346-014_fa81db80-abee-488a-9952-46e40275ddd1 51346-014 HUMAN OTC DRUG BOTANICAL MOIST PACT SPF30 PA PLUS PLUS PLUS 21 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .45; .558; .261 g/9g; g/9g; g/9g 51346-015_1ddfd532-84ae-41a5-ba3e-91b8760a75ff 51346-015 HUMAN OTC DRUG BOTANICAL PURE PACT SPF25 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .4; .62; .2 g/10g; g/10g; g/10g 51346-016_a2a12997-4d7d-4619-b0f1-79a9043cdd06 51346-016 HUMAN OTC DRUG COLLAGEN HD AQUA BB SPF27 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3; 1; 4.15 g/50g; g/50g; g/50g 51346-017_2a71b822-43a3-4f7e-b6fc-f458487ecffa 51346-017 HUMAN OTC DRUG COLLAGEN HD PEARL BB SPF27 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3; 1; 3.8 g/50g; g/50g; g/50g 51346-018_bc2df7b2-176e-4397-82ee-b271a0b33554 51346-018 HUMAN OTC DRUG COLLAGEN HD COVER BB SPF27 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 1; 5.65; .5 g/50g; g/50g; g/50g; g/50g 51346-019_a790eb8e-0711-4f59-a1fb-3c13ac3cf62d 51346-019 HUMAN OTC DRUG COLLAGEN HD PRIIMER BB SPF27 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3; 1; 4.15 g/50g; g/50g; g/50g 51346-020_a4c4c446-b1a0-4b38-b6ab-13b59b83b964 51346-020 HUMAN OTC DRUG RED GINSENG FERMENTED SUN SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE LIQUID TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.92; 1.28; 1.72 g/40mL; g/40mL; g/40mL 51346-021_33d76dbf-7179-458d-928d-0d8a94dee14c 51346-021 HUMAN OTC DRUG RED GINSENG FERMENTED ESSENCE BB SPF50PLUS PA PLUS PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 5.52; 1.56 g/40mL; g/40mL; g/40mL 51346-022_e1312136-b0d3-4c1f-a191-71207b49dd50 51346-022 HUMAN OTC DRUG BEEVENOM BB SPF50PLUS PA PLUS PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 5.52; 1.56 g/40mL; g/40mL; g/40mL 51346-023_0efafa1c-d52b-4d45-920c-cbae86f5b1ee 51346-023 HUMAN OTC DRUG BEEVENOM SUN SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.75; 1; 2.15 g/50mL; g/50mL; g/50mL 51346-024_13a0a801-872c-4e74-a3a9-f0ac4bf3a53a 51346-024 HUMAN OTC DRUG BEEVENOM PACT SPF50PLUS PA PLUS PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .6; 1.16; .29 g/10g; g/10g; g/10g 51346-025_249043e9-34c8-4e8d-978a-a6ee08064850 51346-025 HUMAN OTC DRUG MANGO BEBE LIP CARE SPF15 MINT MANGO OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .21; .11; .0003 g/3.5g; g/3.5g; g/3.5g 51346-026_61d5236b-539c-4c90-bb44-45b100fd1f3c 51346-026 HUMAN OTC DRUG MANGO BEBE LIP CARE SPF15 RED MANGO OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .21; .105; .01 g/3.5g; g/3.5g; g/3.5g 51346-027_80ed37bb-e219-472d-8cab-51e657d086d8 51346-027 HUMAN OTC DRUG MANGO BEBE LIP CARE SPF15 WHITE MANGO OCTINOXATE, OCTISALATE STICK TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE .21; .11 g/3.5g; g/3.5g 51346-028_58a622f2-6ae7-4bff-b14f-0ff475f4cef7 51346-028 HUMAN OTC DRUG MANGO BEBE LIP ESSENCE SPF15 OCTINOXATE, OCTISALATE SOLUTION TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE .6; .3 g/10mL; g/10mL 51346-029_4ebd4e7a-fafd-4a8f-aa1e-523d4793cf35 51346-029 HUMAN OTC DRUG PLACENTA EX DAY SPF30 PA PLUS PLUS OCTINOXATE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE 3.75 g/50mL 51346-030_4bdcca67-976a-4014-b49f-096e078ea622 51346-030 HUMAN OTC DRUG PLACENTA EX ESSENCE BB SPF50PLUS PA PLUS PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.12; 2.21; .63 g/16g; g/16g; g/16g 51346-031_539b3c39-4ee2-4658-ad9f-7f83e4b9949a 51346-031 HUMAN OTC DRUG PLACENTA EX SUN BALM SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .84; .73; .59 g/12g; g/12g; g/12g 51346-032_c4c0c73a-1ca9-4ae1-a0c6-36eac080c56f 51346-032 HUMAN OTC DRUG ORCHID SECRET FOUNDATION 21 SPF28 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120115 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; 2.76; .66 g/35mL; g/35mL; g/35mL 51346-033_66c10460-5eb7-4e3a-9e30-c4b72614f16a 51346-033 HUMAN OTC DRUG ORCHID SECRET FOUNDATION 23 SPF28 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20121115 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; 2.76; .66 g/35mL; g/35mL; g/35mL 51346-034_662e2b08-35fa-4c43-864d-2db1c2ee1636 51346-034 HUMAN OTC DRUG ORCHID SECRET PACT SPF35 PA PLUS PLUS PLUS 21 ORCHID IVORY TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120115 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .72; 1.03; .35 g/12g; g/12g; g/12g 51346-035_b653c070-cf71-45bb-84d0-63421f837c20 51346-035 HUMAN OTC DRUG ORCHID SECRET PACT SPF35 PA PLUS PLUS PLUS 23 ORCHID BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120115 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .72; 1.03; .35 g/12g; g/12g; g/12g 51346-036_41ce2731-abca-492b-9192-ff8abd2c3b9f 51346-036 HUMAN OTC DRUG PHOTOSHOT 3D BB BALM SPF30 PA PLUS PLUS PLUS 21 LIGHT BEIGE TITANIUM DIOXIDE CREAM TOPICAL 20120110 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE 1.52 g/7g 51346-037_c75e5298-d713-43cc-9282-2e7ce5d9c942 51346-037 HUMAN OTC DRUG PHOTOSHOT 3D BB BALM SPF30 PA PLUS PLUS PLUS 23 NATURAL BEIGE TITANIUM DIOXIDE CREAM TOPICAL 20120110 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE 1.52 g/7g 51346-038_bf682ead-4d76-4489-bc50-f28212a16d84 51346-038 HUMAN OTC DRUG UV LOCK FLOWER DAILY POWERFUL SUN SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 3.75; 2.5; 1.25; 2.4 g/50mL; g/50mL; g/50mL; g/50mL 51346-039_ffa6cebe-2c78-47ec-acdd-bf00599ee6bd 51346-039 HUMAN OTC DRUG UV LOCK FLOWER KIDS AND JUNIOR SUN SPF35 PA PLUS PLUS OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 3.75; 1.05 g/50mL; g/50mL 51346-040_0e72397c-4bf6-4f59-9fb6-cb8e7d5b9244 51346-040 HUMAN OTC DRUG UV LOCK FLOWER WATER PROOF SUN SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 3.75; 2.5; 1.45; 2.45 g/50mL; g/50mL; g/50mL; g/50mL 51346-041_0c949b5c-2fbb-420e-a7a7-f4be505f3210 51346-041 HUMAN OTC DRUG UV LOCK ULTRA PACT SUN SPF50PLUS PA PLUS PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .24; .62; .23 g/8g; g/8g; g/8g 51346-042_22bf2199-626e-42b3-96a9-135ddcdda714 51346-042 HUMAN OTC DRUG UV LOCK ULTRA MILK SUN SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 3.75; 2.5; 1.25; 3.25 g/50mL; g/50mL; g/50mL; g/50mL 51346-043_24b22dcd-5b42-4894-87aa-12180f2e02f2 51346-043 HUMAN OTC DRUG UV LOCK ULTRA MILK SUN BIG SIZE SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 5.25; 3.5; 1.75; 4.55 g/70mL; g/70mL; g/70mL; g/70mL 51346-044_682285d0-f83f-4fcd-b38f-40d5bf1d37b7 51346-044 HUMAN OTC DRUG SNAIL THERAPY 50 BB SPF30 PA PLUS PLUS NO2 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; 3.16; .76 g/40mL; g/40mL; g/40mL 51346-045_4f361924-cce0-444d-97ec-da6f60a33a46 51346-045 HUMAN OTC DRUG SNAIL THERAPY 50 BB SPF30 PA PLUS PLUS NO1 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; 3.16; .76 g/40mL; g/40mL; g/40mL 51346-046_fb8425ac-6eca-401e-8d93-94ff8e8d425b 51346-046 HUMAN OTC DRUG MULTI PERFECTION SPECIAL EFFECTOR SPF15 OCTINOXATE, OCTISALATE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE 7.87; 4.2 g/105mL; g/105mL 51346-047_6556e617-14cc-4304-8bdf-bd1656c72a5f 51346-047 HUMAN OTC DRUG BOTANICAL MOIST PACT SPF30 PA PLUS PLUS PLUS 23 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .45; .56; .26 g/9g; g/9g; g/9g 51346-048_baaf4d7d-b73c-4039-9a57-5eae467e4737 51346-048 HUMAN OTC DRUG BOTANICAL FRESH BB SPF30 PA PLUS PLUS TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.6; .35 g/25mL; g/25mL 51346-049_2351bc3e-468d-4614-be25-3e6ba79dc270 51346-049 HUMAN OTC DRUG SNAIL THERAPY PACT 21 SPF25 PA PLUS PLUS TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.07; .11 g/11g; g/11g 51346-050_cb95d270-a153-43ba-8f49-244dd65933cb 51346-050 HUMAN OTC DRUG SNAIL THERAPY PACT 23 SPF25 PA PLUS PLUS TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.07; .11 g/11g; g/11g 51346-051_3dfecfee-4984-4470-ad59-17aa12ae61b1 51346-051 HUMAN OTC DRUG BLEMISH LAB BYE PORE BB SPF30 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; 2.37; .57 g/30mL; g/30mL; g/30mL 51346-052_cb3355a4-d777-4235-a574-746b5fcccd82 51346-052 HUMAN OTC DRUG SUPER ORIGIN COLLAGEN WATERPROOF BB SPF46 PA PLUS PLUS PLUS OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, OCTISALATE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 3.15; 1.35; 3.1; 2.2 g/45g; g/45g; g/45g; g/45g 51346-053_31b22ca2-0f54-4a03-8846-91bb952216de 51346-053 HUMAN OTC DRUG SUPER ORIGIN CERAMIDE BB SPF25 PA PLUS PLUS TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.47; .63 g/45g; g/45g 51346-054_ba0632d9-9200-4b5a-94bf-2b5602d6adb3 51346-054 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX BB SPF30 PA PLUS PLUS 01 LIGHT BB TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20111130 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.35; 3.92; .86 g/45g; g/45g; g/45g 51346-055_9ea801dd-9c76-4531-a7bb-b714c45023e8 51346-055 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX BB SPF30 PA PLUS PLUS 02 NATURAL TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20111130 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.35; 3.92; .86 g/45g; g/45g; g/45g 51346-056_4745ac76-5706-424c-a93f-c0ba1d3c608e 51346-056 HUMAN OTC DRUG ORCHID SECRET SPF30 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20111130 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .23; 1.25 g/12g; g/12g 51346-057_60998fa6-6653-4933-b5b3-5389ea22eaeb 51346-057 HUMAN OTC DRUG VIVID TINT BAR 02 SPF15 PA PLUS TITANIUM DIOXIDE STICK TOPICAL 20111130 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE .002 g/3.5g 51346-058_966eed6b-b959-4511-acc0-050a3e446a6b 51346-058 HUMAN OTC DRUG TRUFFLE EX RETINOL SPOT DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .64 g/40mL 51346-059_bbbee0c5-efa5-4e5a-be33-f0d85f066605 51346-059 HUMAN OTC DRUG TRUFFLE EX WRINKLE DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1 g/50mL 51346-060_87db63c6-b22f-453c-87b0-97293b21dec8 51346-060 HUMAN OTC DRUG TRUFFLE EX WRINKLE EMULSION DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.65 g/150mL 51346-061_866c6e53-4c5d-4fe8-a18e-95b6b088c54b 51346-061 HUMAN OTC DRUG TRUFFLE EX WRINKLE ESSENCE DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2 g/40mL 51346-062_c31e386f-298b-4bc6-ab84-d930076678df 51346-062 HUMAN OTC DRUG TRUFFLE EX WRINKLE EYE DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .75 g/30mL 51346-063_9c37a53c-9355-4865-b5ae-903a45ae55f6 51346-063 HUMAN OTC DRUG PLACENTA EX ESSENCE Dimethicone CREAM TOPICAL 20101001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .4 g/40mL 51346-064_45b73f8b-0002-48cc-b8c8-d347abb76bbb 51346-064 HUMAN OTC DRUG PLACENTA EX EMULSION Dimethicone CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2.38 g/140mL 51346-065_ef6b7fcc-cc14-42f0-9238-1b199997f5d1 51346-065 HUMAN OTC DRUG PLACENTA EX NIGHT Dimethicone CREAM TOPICAL 20101001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 6.75 g/50mL 51346-066_000e42cd-7833-4dca-bcaa-b839572ccbe1 51346-066 HUMAN OTC DRUG CELLBOOSTING HOMME DIMETHICONE LOTION TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.5 g/150mL 51346-067_3da96469-1126-48e6-ad7a-6bbb45f1fc42 51346-067 HUMAN OTC DRUG CELLBOOSTING HOMME SKIN GLYCERIN CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 30.75 g/150mL 51346-068_b0d1ae50-d750-4219-a576-d1d5a0b66eaa 51346-068 HUMAN OTC DRUG CELLBOOSTING WHITENING TONER GLYCERIN CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 31.2 g/150mL 51346-069_d168d457-358f-44a3-af7e-5a7a273efbf1 51346-069 HUMAN OTC DRUG CELLBOOSTING HOMME WHITENING FLUID DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.5 g/150mL 51346-070_86c55d58-8e38-425b-ab40-90f7d9ed9140 51346-070 HUMAN OTC DRUG POLYNESIA LAGOON WATER HYDRO SKIN GLYCERIN, DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE; GLYCERIN 6.84; 38.52 g/180mL; g/180mL 51346-071_48d4de10-8f68-468d-a7e3-ffb49e9c2c76 51346-071 HUMAN OTC DRUG POLYNESIA LAGOON WATER HYDRO EMULSION GLYCERIN CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 37.8 g/180mL 51346-072_d33911ce-2c5b-4245-987c-e105d19f68dd 51346-072 HUMAN OTC DRUG POLYNESIA LAGOON WATER HYDRO ESSENCE DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .55 g/50mL 51346-073_863d9c38-998a-4329-bf7b-8f22ba046dd9 51346-073 HUMAN OTC DRUG POLYNESIA LAGOON WATER HYDRO DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.1 g/55mL 51346-074_b0495cf1-8758-4512-803f-fe1ef20c138e 51346-074 HUMAN OTC DRUG POLYNESIA LAGOON WATER HYDRO EYE GLYCERIN CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 7 g/35mL 51346-076_0cdc57e4-0e5b-44c3-930b-bd967ed15800 51346-076 HUMAN OTC DRUG COLLAGEN HD FOUNDATION SPF30 PA PLUS PLUS 21 SOFT BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; 3.16; .76 g/40mL; g/40mL; g/40mL 51346-077_1e115264-2388-4ca2-a2d5-86d17688e97b 51346-077 HUMAN OTC DRUG BOTANICAL FRESH BB SET SPF30 PA PLUS PLUS Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120401 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.6; .35 g/1; g/1 51346-078_0fca1589-0c9c-42c9-ba51-e5b73c036e0f 51346-078 HUMAN OTC DRUG SUPER ORIGIN COLLAGEN BB SPF25 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120401 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.35; 2.88; .85 g/45g; g/45g; g/45g 51346-079_b25f09ce-ea45-4a7a-a59c-6d98f952b661 51346-079 HUMAN OTC DRUG THE FIRST EMULSION DIMETHICONE CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.5 g/150mL 51346-080_ebb37f33-f03d-4735-ad99-37324dd7d93a 51346-080 HUMAN OTC DRUG THE FIRST AMPOULE ESSENCE GLYCERIN CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 10.16 g/40mL 51346-081_7930301d-5130-468b-9b9d-389a2f03c36c 51346-081 HUMAN OTC DRUG THE FIRST DIMETHICONE CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.55 g/50mL 51346-082_864893a7-f34a-4db8-8d5e-5edb10c3afe0 51346-082 HUMAN OTC DRUG THE FIRST EYE DIMETHICONE CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .81 g/30mL 51346-083_7b3f1abe-9b54-4d3d-8791-8ef7a7221e1c 51346-083 HUMAN OTC DRUG GIVEN BY NATURE ALOE MASK SHEET GLYCERIN CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.83 g/23mL 51346-084_924e1c31-c445-461c-9e39-2b37c8bcde46 51346-084 HUMAN OTC DRUG GIVEN BY NATURE BAMBOO MASK SHEET GLYCERIN CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.6 g/23mL 51346-085_90c4e191-0637-4122-b416-c253b2f696fc 51346-085 HUMAN OTC DRUG GIVEN BY NATURE ROSE HIP MASK SHEET GLYCERIN CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.6 g/23mL 51346-086_5b8721ab-6a22-4d9e-b77a-444f87dca074 51346-086 HUMAN OTC DRUG GIVEN BY NATURE CHERRY BLOSSOM MASK SHEET GLYCERIN CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.6 g/23mL 51346-087_b4a902c4-4d48-4796-8bcb-5b1dcd8be572 51346-087 HUMAN OTC DRUG SOLIE TONER GLYCERIN, ALLANTOIN CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. ALLANTOIN; GLYCERIN .75; 30 g/150mL; g/150mL 51346-088_7638a441-1745-440c-bbd5-1cab2618dd6f 51346-088 HUMAN OTC DRUG SOLIE EMULSION DIMETHICONE CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 9.75 g/150mL 51346-089_014458ed-f965-4901-a46b-749c549513cf 51346-089 HUMAN OTC DRUG SOLIE ESSENCE GLYCERIN CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 10 g/50mL 51346-090_627d6fe8-cfb3-445f-bb67-ca0436df79c5 51346-090 HUMAN OTC DRUG SOLIE DIMETHICONE CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .77 g/55mL 51346-091_f3b6e497-8df5-4f52-9e9f-7f41460c3f2f 51346-091 HUMAN OTC DRUG SOLIE EYE DIMETHICONE CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.35 g/30mL 51346-092_4be2929f-8d54-4aca-a369-6014ec16a584 51346-092 HUMAN OTC DRUG RED GINSENG FERMENTED ESSENCE BOOSTER Dimethicone CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2 g/80mL 51346-093_8ab543e3-1776-46aa-8e8b-9fe8a125b652 51346-093 HUMAN OTC DRUG RED GINSENG FERMENTED TONER Glycerin CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 28 g/140mL 51346-094_643bcdcc-21b6-4372-b42b-5dc4d6f2fe97 51346-094 HUMAN OTC DRUG RED GINSENG FERMENTED EMULSION Dimethicone CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2.66 g/140mL 51346-095_21041e47-f7c5-481d-b9b8-418820ae594f 51346-095 HUMAN OTC DRUG RED GINSENG FERMENTED ESSENCE Dimethicone CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.6 g/40mL 51346-096_258b764f-82dc-44d5-955d-dd37db5302d1 51346-096 HUMAN OTC DRUG RED GINSENG FERMENTED Dimethicone CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.25 g/50mL 51346-097_a3d1c952-6ea6-4e9a-b64d-27db7b042fab 51346-097 HUMAN OTC DRUG RED GINSENG FERMENTED Dimethicone OIL TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.2 g/30mL 51346-098_dee39131-cb63-483a-930f-2434bc79a11b 51346-098 HUMAN OTC DRUG ESSENTIAL SOLUTION COLLAGEN MASK SHEET GLYCERIN, ALLANTOIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. ALLANTOIN; GLYCERIN .14; 6.72 g/28g; g/28g 51346-099_89d0f1ab-281e-416d-9650-7fbf36885e0d 51346-099 HUMAN OTC DRUG ESSENTIAL SOLUTION HYALURONIC ACID MASK SHEET GLYCERIN, ALLANTOIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. ALLANTOIN; GLYCERIN .14; 5.6 g/28g; g/28g 51346-100_6145e14a-e11b-4c5f-8125-10cdd7888c18 51346-100 HUMAN OTC DRUG ESSENTIAL SOLUTION COENZYME Q10 MASK SHEET GLYCERIN, ALLANTOIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. ALLANTOIN; GLYCERIN .14; 5.6 g/28g; g/28g 51346-101_54a5a69d-77d9-4c70-8f18-bf95940d543a 51346-101 HUMAN OTC DRUG ESSENTIAL SOLUTION VITA A MASK SHEET GLYCERIN, ALLANTOIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. ALLANTOIN; GLYCERIN .14; 5.6 g/28g; g/28g 51346-102_d41185c0-ec6c-4d57-bda5-ee183750f2f3 51346-102 HUMAN OTC DRUG ESSENTIAL SOLUTION VITA C MASK SHEET GLYCERIN, ALLANTOIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. ALLANTOIN; GLYCERIN .14; 5.6 g/28g; g/28g 51346-103_3881eb0c-21a6-4c65-a1ee-b39f4eb168fa 51346-103 HUMAN OTC DRUG ESSENTIAL SOLUTION RED GINSENG MASK SHEET GLYCERIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4 g/20mL 51346-104_657a1d55-8703-40c7-8bc2-9a6fbb29568d 51346-104 HUMAN OTC DRUG ESSENTIAL SOLUTION CAVIAR MASK SHEET GLYCERIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4 g/20mL 51346-105_d2a1c4bc-d61f-426c-90ad-940890793996 51346-105 HUMAN OTC DRUG ESSENTIAL SOLUTION PEARL MASK SHEET GLYCERIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4 g/20mL 51346-106_02ce3f7f-e4f7-4d73-87e8-d4a8675b964f 51346-106 HUMAN OTC DRUG ESSENTIAL SOLUTION HONEY MASK SHEET GLYCERIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4 g/20mL 51346-107_aa34fc92-45f4-4275-956d-2748f1e0255f 51346-107 HUMAN OTC DRUG BEEVENOM TONER Glycerin CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 30 g/150mL 51346-108_3faed97c-badd-4103-b709-13d2b78d28bc 51346-108 HUMAN OTC DRUG BEEVENOM EMULSION Glycerin CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 30 g/150mL 51346-109_d843d4b7-c87e-4214-af1c-13cd02e29e8e 51346-109 HUMAN OTC DRUG BEEVENOM ESSENCE Dimethicone CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .36 g/30mL 51346-110_aef38ebd-7dcf-4754-8121-e2d5c99d20d6 51346-110 HUMAN OTC DRUG BEEVENOM Glycerin, Dimethicone CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE; GLYCERIN .5; 10 g/50mL; g/50mL 51346-111_0af7ad6f-abc8-462c-9fb3-f370f03a441f 51346-111 HUMAN OTC DRUG BEEVENOM MASK SHEET GLYCERIN, ALLANTOIN CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. ALLANTOIN; GLYCERIN .115; 4.83 g/23mL; g/23mL 51346-112_3e52b88f-8aaf-46b6-8420-d90aaa817553 51346-112 HUMAN OTC DRUG GIVEN BY NATURE GREEN TEA MASK SHEET GLYCERIN CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.6 g/23mL 51346-113_bcca49c0-7cea-46c9-998a-98f3a505af65 51346-113 HUMAN OTC DRUG GIVEN BY NATURE OLIVE MASK SHEET GLYCERIN CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.83 g/23mL 51346-114_a1bdfd97-406f-4e16-9f12-5fa68a189631 51346-114 HUMAN OTC DRUG GIVEN BY NATURE TEA TREE MASK SHEET GLYCERIN CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.6 g/23mL 51346-115_b896ce5b-8ddb-403e-99c2-0e1e5323e235 51346-115 HUMAN OTC DRUG GIVEN BY NATURE RICE MASK SHEET GLYCERIN CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.6 g/23mL 51346-116_97a2f7a6-63e3-4603-973b-401831e67806 51346-116 HUMAN OTC DRUG GIVEN BY NATURE SHEA BUTTER MASK SHEET DIMETHICONE CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .46 g/23mL 51346-117_4e18fa24-20fe-4659-afc2-69dfba4f7d1e 51346-117 HUMAN OTC DRUG BETTER THAN NATURE SKIN SOFTNER GLYCERIN CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 30 g/150mL 51346-118_18ca97e9-febf-4405-9ee4-6a64aae7b6b5 51346-118 HUMAN OTC DRUG BETTER THAN NATURE EMULSION DIMETHICONE CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2.25 g/150mL 51346-119_d30765d3-b163-461a-bf90-ef1473559f96 51346-119 HUMAN OTC DRUG BETTER THAN NATURE ESSENCE DIMETHICONE CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.25 g/50mL 51346-120_2b9b7363-9915-4e20-a108-a2f2aab1f36f 51346-120 HUMAN OTC DRUG BETTER THAN NATURE EYE ESSENCE DIMETHICONE CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .3 g/30mL 51346-121_f15eb156-5ec9-4751-96c7-62c5c17a3e37 51346-121 HUMAN OTC DRUG THE BAMBOO OF DAMYANG MOISTURE TONER GLYCERIN CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 30 g/150mL 51346-122_7b419f31-9280-4f3f-990a-a20c276e8432 51346-122 HUMAN OTC DRUG THE BAMBOO OF DAMYANG MOISTURE DIMETHICONE LOTION TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.5 g/150mL 51346-123_6a1af5a2-d866-4ef6-bf11-06a830fcc924 51346-123 HUMAN OTC DRUG THE BAMBOO OF DAMYANG MOISTURE ESSENCE DIMETHICONE, ALLANTOIN CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. ALLANTOIN; DIMETHICONE .2; .4 g/40mL; g/40mL 51346-124_2be28b46-62bb-4aa0-88dc-c12982ba46ed 51346-124 HUMAN OTC DRUG THE BAMBOO OF DAMYANG MOISTURE EYE DIMETHICONE CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .5 g/25mL 51346-125_6095c198-0f4e-495c-9369-b1be704d545e 51346-125 HUMAN OTC DRUG SUPER AQUA MAX DEEP MOISTURE HYDROGEL MASK SHEET Glycerin, Allantoin CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. ALLANTOIN; GLYCERIN .125; 5 g/25g; g/25g 51346-126_e493ca4f-19ea-4865-b94b-ce389678acb2 51346-126 HUMAN OTC DRUG SUPER AQUA MAX DEEP MOISTURE SLEEPING PACK DIMETHICONE CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2 g/100mL 51346-127_864869b7-9116-4d88-9a1f-dfb802bf0ccb 51346-127 HUMAN OTC DRUG SUPER AQUA MAX WHITE C WATERFUL TONER Glycerin CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 30 g/150mL 51346-128_1cbe2aac-d7f3-427c-b6e8-46bed104943c 51346-128 HUMAN OTC DRUG SUPER AQUA MAX WHITE C WATERFUL EMULSION Dimethicone CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.5 g/150mL 51346-129_aa19a8bd-8abf-4e28-9ff9-1abab0ff9778 51346-129 HUMAN OTC DRUG SUPER AQUA MAX WHITE C CRYSTAL ESSENCE Glycerin CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 8 g/40mL 51346-130_eb5ad6af-f469-4ac4-9e5d-e7e3084688a4 51346-130 HUMAN OTC DRUG SUPER AQUA MAX WHITE C LUMINOUS AMPOULE DIMETHICONE CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.575 g/35mL 51346-131_a3deca27-ce3f-47db-b4b4-778dc492b927 51346-131 HUMAN OTC DRUG SUPER AQUA MAX WHITE C EYE BRIGHTENER DIMETHICONE CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .3 g/20mL 51346-132_0bf8839b-91e3-4f6e-9b42-bc175783a89e 51346-132 HUMAN OTC DRUG ORIGINAL POWER ENERGY AMPOULE GLYCERIN, DIMETHICONE SOLUTION TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE; GLYCERIN .3; 6.57 g/30mL; g/30mL 51346-133_f4471811-332b-4019-a160-3f6eb064ab9d 51346-133 HUMAN OTC DRUG ORIGINAL POWER WHITENING AND LINELESS AMPOULE GLYCERIN, DIMETHICONE SOLUTION TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE; GLYCERIN .48; 6.72 g/30mL; g/30mL 51346-134_02fa00df-02c8-4a12-88ba-f760a53053bc 51346-134 HUMAN OTC DRUG ORIGINAL POWER HYDRO AMPOULE GLYCERIN, DIMETHICONE SOLUTION TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE; GLYCERIN .3; 6 g/30mL; g/30mL 51346-135_8029d6ec-dd7e-4448-9cce-3ad7a49dba3e 51346-135 HUMAN OTC DRUG ORIGINAL POWER LIFTING AMPOULE GLYCERIN, DIMETHICONE SOLUTION TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE; GLYCERIN .3; 6.66 g/30mL; g/30mL 51346-136_3b5aed0d-2ba5-4088-9ac2-8a12a3df2e29 51346-136 HUMAN OTC DRUG ORIGINAL POWER ARGAN OIL AMPOULE WITCH HAZEL SOLUTION TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. WITCH HAZEL .015 g/30mL 51346-137_5c67ffb5-1ed2-41b7-b98b-26ad06c071c1 51346-137 HUMAN OTC DRUG SNAYTOX ESSENCE BOOSTER DIMETHICONE CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .4 g/40mL 51346-138_89bac60d-28b0-4307-b70a-bdb7e94ddb05 51346-138 HUMAN OTC DRUG SNAYTOX ESSENCE DIMETHICONE CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .76 g/40mL 51346-139_8e85e7e3-70f8-4f5a-ac0a-fc0691259f1e 51346-139 HUMAN OTC DRUG SNAYTOX DIMETHICONE CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.65 g/55mL 51346-140_360e4241-312a-4f1e-9eb8-a7c397e5f590 51346-140 HUMAN OTC DRUG SNAYTOX EYE AND LIP DIMETHICONE CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .375 g/25mL 51346-141_c17ec7e9-dd95-4be4-9cd3-471381ad93a2 51346-141 HUMAN OTC DRUG SOOTHING AND MOISTURE ALOE VERA 90 PERCENT TONER Glycerin CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 36 g/160mL 51346-142_710638f7-5156-4e8d-b0bc-6ee38a57dbd8 51346-142 HUMAN OTC DRUG SOOTHING AND MOISTURE ALOE VERA 80 PERCENT EMULSION Dimethicone CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2.56 g/160mL 51346-143_5d6f5657-d037-4e62-b34c-105f7110a4fa 51346-143 HUMAN OTC DRUG SOOTHING AND MOISTURE ALOE VERA 92 PERCENT SOOTHING Glycerin GEL TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 60 g/300mL 51346-144_cd72315a-c2cc-420b-b2ae-debe4a333a1c 51346-144 HUMAN OTC DRUG SNAYTOX ANTI WRINKLE HYDRO MASK GLYCERIN GEL TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 5 g/25g 51346-145_57a889cf-8a72-4468-8721-ceae2dae53e2 51346-145 HUMAN OTC DRUG SNAYTOX WRINKLE FILLER SPECIAL SET Glycerin CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4 g/20mL 51346-146_8b273789-5be8-435e-81b2-af3d15a8d5f3 51346-146 HUMAN OTC DRUG SNAIL THERAPY 1000 HYDROGEL MASK SHEET GLYCERIN CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.2 g/20g 51346-147_c9d73014-841e-4243-bc0e-42e45cc9a386 51346-147 HUMAN OTC DRUG SNAIL THERAPY 90 SKIN BOOSTER Dimethicone CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.2 g/120mL 51346-148_f9db3412-6e62-4f0f-93ff-5194c44d2451 51346-148 HUMAN OTC DRUG SNAIL THERAPY 80 EMULSION DIMETHICONE CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.296 g/120mL 51346-149_640befda-dcf7-47dd-abd1-4860ea886ed3 51346-149 HUMAN OTC DRUG SNAIL THERAPY 70 ESSENCE DIMETHICONE CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .968 g/40mL 51346-150_fa12e126-3391-468c-af62-910b0f6a45f1 51346-150 HUMAN OTC DRUG SNAIL THERAPY 50 SLEEPING MASK DIMETHICONE CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.6 g/100mL 51346-151_d2956006-dd7d-43f9-8bb8-d5ee9b8cdb05 51346-151 HUMAN OTC DRUG SNAIL THERAPY 70 EYE GLYCERIN CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 6 g/30mL 51346-152_28ca1d3e-9949-4ff2-8e48-683c2d4c510f 51346-152 HUMAN OTC DRUG SNAIL THERAPY 80 AMPOULE DIMETHICONE SOLUTION TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .3 g/30mL 51346-153_437153e5-3741-4acf-bf78-656bcb71dbfc 51346-153 HUMAN OTC DRUG SNAIL THERAPY 70 SPECIAL SET DIMETHICONE CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .77 g/55mL 51346-154_b6dc8856-b41f-4623-8e77-e0f469babd3f 51346-154 HUMAN OTC DRUG PLEASURE GARDEN HOMME SPORTS MASK GLYCERIN CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4 g/20mL 51346-155_c5b6be7f-7b12-4e41-b99e-e88203a84714 51346-155 HUMAN OTC DRUG TRUFFLE EX CLEANSING MINERAL OIL OIL TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. MINERAL OIL 100 g/200mL 51346-156_f7d55f9b-c7c0-4f86-8f22-143a2aa0fe04 51346-156 HUMAN OTC DRUG TRUFFLE EX WRINKLE TONER GLYCERIN CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 32.7 g/150mL 51346-157_8acaae97-8200-4a99-8bbc-3a9aec10b4ac 51346-157 HUMAN OTC DRUG TRUFFLE EX TREATMENT WITCH HAZEL OIL TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. WITCH HAZEL .015 g/30mL 51346-158_66aa1301-0ce1-4162-b68d-4132e479c908 51346-158 HUMAN OTC DRUG TRUFFLE EX WRINKLE SLEEPING MASK Dimethicone CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 3.6 g/90mL 51346-159_3c71a760-2113-40f0-a325-01edc99a1ecc 51346-159 HUMAN OTC DRUG PLACENTA EX TONER Dimethicone CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.4 g/140mL 51346-160_bb2eec8b-8ef0-4753-8a89-b62817166442 51346-160 HUMAN OTC DRUG PLACENTA EX EYE Dimethicone CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .36 g/30mL 51346-161_a9b9e9aa-f5bb-4b7d-adc4-a9fd91d63629 51346-161 HUMAN OTC DRUG PLACENTA EX AMPOULE Glycerin SOLUTION TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 7.35 g/30mL 51346-162_dbee1c33-7f76-4407-b253-4a154d9bf5fe 51346-162 HUMAN OTC DRUG ESSENTIAL BODY RELAXING ESSENCE Glycerin CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 53.67 g/250mL 51346-163_11608ebb-05ef-4f5a-89ca-b1e713709d44 51346-163 HUMAN OTC DRUG ESSENTIAL BODY MOISTURIZING ESSENCE Glycerin CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 53.67 g/250mL 51346-164_cd724ce1-8e89-462d-a331-4e83131d9a49 51346-164 HUMAN OTC DRUG ESSENTIAL BODY NUTRITIVE BUTTER Glycerin, Dimethicone CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE; GLYCERIN 2; 40 g/200mL; g/200mL 51346-165_d50006f9-d00d-4f1f-85b0-9c79eb8d8d33 51346-165 HUMAN OTC DRUG MACCOLA Glycerin SOAP TOPICAL 20111101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 12 g/60g 51346-166_f2776fd6-ee02-42a3-b58f-9212b514041a 51346-166 HUMAN OTC DRUG THE FIRST WHITENING SLEEPING MASK Glycerin CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 18 g/90mL 51346-167_ecca5c21-d32c-4f63-a99a-27ff94f69595 51346-167 HUMAN OTC DRUG BEEVENOM SLEEPING MASK Glycerin CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 18 g/90mL 51346-168_39c770cd-e275-4c08-a877-1e1ae3ccea4e 51346-168 HUMAN OTC DRUG AQUA COLLAGEN SOLUTION MARINE HYDROGEL EYE GLYCERIN PATCH TOPICAL 20111101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 1.7 g/8.5g 51346-169_89083a9f-d027-4d43-ba37-20f3415f9966 51346-169 HUMAN OTC DRUG AQUA COLLAGEN SOLUTION MARINE HYDROGEL MASK DIMETHICONE CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .2 g/20g 51346-170_06f54bc0-50d9-4cf4-ad78-4903f0139ace 51346-170 HUMAN OTC DRUG AQUA COLLAGEN SOLUTION EYE TREATMENT MASK Glycerin CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 1.8 g/9g 51346-171_7ac2df46-7e4f-4afa-abaa-333ded6e9577 51346-171 HUMAN OTC DRUG FRESH AFTER VACANCE BODY SOOTHING Glycerin GEL TOPICAL 20111101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 30 mL/150mL 51346-172_e00ad3d2-5d8c-4482-a52f-6faccd1150bd 51346-172 HUMAN OTC DRUG ORCHID SECRET BASE 01 SECRET GREEN TITANIUM DIOXIDE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE .8 g/35mL 51346-173_76cdaf13-d250-4b22-a0c7-aa57025d5ad3 51346-173 HUMAN OTC DRUG ORCHID SECRET BASE 02 SECRET PEARL PINK TITANIUM DIOXIDE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE .87 mL/35mL 51346-174_3180a867-e62f-485f-9514-cdcc205f24c7 51346-174 HUMAN OTC DRUG SOOTHING AND MOISTURE ALOE VERA 90 PERCENT BODY Glycerin CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 30 g/150mL 51346-175_c50db061-702f-474a-a013-40dae8b83a1e 51346-175 HUMAN OTC DRUG HAND AND NATURE ANTI WRINKLE HAND ARAGON OIL Glycerin, Dimethicone CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE; GLYCERIN .6; 12 g/60mL; g/60mL 51346-176_ba995c71-ff1c-491f-9609-a3859108fe3c 51346-176 HUMAN OTC DRUG HAND AND NATURE ANTI WRINKLE HAND ALMOND OIL Glycerin, Dimethicone CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE; GLYCERIN .6; 12 g/60mL; g/60mL 51346-177_f66de533-9ecc-4092-b228-d08eaf81f3e3 51346-177 HUMAN OTC DRUG MULTI PERFECTION MAX DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1 g/50mL 51346-178_bde9df31-9ed9-4b35-94be-4c389d44ff88 51346-178 HUMAN OTC DRUG MULTI PERFECTION SUPER Glycerin CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 11.45 g/50mL 51346-179_8be58a98-9708-4064-a4a5-09d2b73ea8e7 51346-179 HUMAN OTC DRUG MULTI PERFECTION ULTRA DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.5 g/50mL 51346-180_982b45ed-4478-48b1-a702-23da86aae85b 51346-180 HUMAN OTC DRUG AFRICA BIRD HOMME ALL IN ONE MOISTURIZER GLYCERIN CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 31.5 g/150mL 51346-181_d4444a61-ac72-4dca-9554-b8a770da1088 51346-181 HUMAN OTC DRUG AFRICA BIRD HOMME ALL IN ONE FRESH CONTROLLER DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.95 g/150mL 51346-182_01928dd3-80fc-4ce3-89ba-d80cbeacedca 51346-182 HUMAN OTC DRUG FOREVER LASTING PRECIOUS OIL ESSENCE GLYCERIN CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 8.15 g/40mL 51346-183_fe1a21e2-765a-400f-9b9e-33d7783360f4 51346-183 HUMAN OTC DRUG FOREVER LASTING PRECIOUS ESSENTIAL WATER GLYCERIN CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 31.65 g/155mL 51346-184_ba00abae-ec39-4b99-89c2-25a2ea1d1f2b 51346-184 HUMAN OTC DRUG SHAKING SMOOTHIE ALOE MASK Witch Hazel CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. WITCH HAZEL .01 g/1 51346-185_518dcaa0-3961-4b9c-a0b1-97894b97225b 51346-185 HUMAN OTC DRUG SHAKING SMOOTHIE LEMON MASK Witch Hazel CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. WITCH HAZEL .01 g/1 51346-186_7d3a74ea-9b02-45a9-9611-8a54c8d505c8 51346-186 HUMAN OTC DRUG THE FIRST CLEAR TONER WITCH HAZEL CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. WITCH HAZEL .09 g/150mL 51346-187_310b871a-5329-420d-b232-31c0b650f748 51346-187 HUMAN OTC DRUG COLLAGEN HD FOUNDATION SPF30 PA PLUS PLUS 23 MEDIUM BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; 3.16; .76 g/40mL; g/40mL; g/40mL 51346-188_d75ba793-a26d-4559-8cbb-b6ebee33ba24 51346-188 HUMAN OTC DRUG FOREVER LASTING ESSENTIAL EMULSION DIMETHICONE CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 5.45 g/125mL 51346-189_05345f3e-4b23-4df2-943f-5ab543b3205b 51346-189 HUMAN OTC DRUG FOREVER LASTING PRECIOUS MELTING DIMETHICONE CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .605 g/55mL 51346-190_937580f1-512b-4827-bb5a-b3b6c18c0d0a 51346-190 HUMAN OTC DRUG FOREVER LASTING INTENSIVE SPOT DIMETHICONE CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .46 g/20mL 51346-191_2b4e7a73-e142-4c42-ae58-d387008427da 51346-191 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX DAY Dimethicone CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.375 g/55mL 51346-192_14fe1e94-670a-4e3f-8903-c2b8e7c1e41d 51346-192 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX NIGHT Glycerin CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 11.55 g/55mL 51346-193_a3e4f52c-d794-4665-89f2-e68599862aca 51346-193 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX FLUID Dimethicone CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.32 g/120mL 51346-194_0c0f511a-c547-4e7e-a1b9-3a5868c4064c 51346-194 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX EYE Dimethicone CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .3 g/25mL 51346-195_d9ed52f6-7ffd-4275-9d5c-696fcf0af71b 51346-195 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX SERUM Dimethicone CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .48 g/40mL 51346-196_c2ac078a-e2f1-4561-ac51-011f97bbb7a4 51346-196 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX TONER Glycerin CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 24.6 g/120mL 51346-197_5ccae925-e6a4-41e2-b88a-50572b4a94af 51346-197 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX WATERY Glycerin CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 12.1 g/55mL 51346-198_ffbb4b51-7233-4e11-8d5d-d8a978903958 51346-198 HUMAN OTC DRUG PLACENTA EX DEEP LINE WITCH HAZEL PATCH TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. WITCH HAZEL .0007 g/21 51346-199_aee6e36a-cded-4108-82c9-d85d0e67e2be 51346-199 HUMAN OTC DRUG SNAYTOX HYDROGEL LIP Witch Hazel PATCH TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. WITCH HAZEL .1 g/10g 51346-200_b34a465f-769a-4fce-8c77-25c1bbdcab0f 51346-200 HUMAN OTC DRUG PROVENCE MELTING FOUNDATION BRIGHT BEIGE SPF32 PA PLUS PLUS Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .65; 2.47; .63 g/13g; g/13g; g/13g 51346-201_41cbb659-8cc2-4ab1-a7b7-2030b1527d83 51346-201 HUMAN OTC DRUG PROVENCE MELTING FOUNDATION NATURAL BEIGE SPF32 PA PLUS PLUS Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .65; 2.47; .63 g/13g; g/13g; g/13g 51346-202_97763693-3307-4a01-97d8-f57b0e83ae1e 51346-202 HUMAN OTC DRUG PROVENCE FOUNDATION SPF31 PA PLUS PLUS NO 21 Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.4; 3.65; .34 mg/35mL; mg/35mL; mg/35mL 51346-203_73bb9b94-3ab1-4c03-9e21-e13aa09534ac 51346-203 HUMAN OTC DRUG PROVENCE FOUNDATION SPF31 PA PLUS PLUS NO 23 Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.4; 3.65; .34 mg/35mL; mg/35mL; mg/35mL 51346-204_2e9b85bc-3502-424f-828e-e07e0c7c5c88 51346-204 HUMAN OTC DRUG PROVENCE MAKEUP BASE SPF30 PA PLUS PLUS 01 MINT OCTINOXATE, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; 1.46; 1.71 mg/35mL; mg/35mL; mg/35mL 51346-205_3716832e-99fc-4bda-98d9-5f5052c786e9 51346-205 HUMAN OTC DRUG PROVENCE MAKEUP BASE SPF30 PA PLUS PLUS 02 LAVENDER OCTINOXATE, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; 1.46; 1.71 mg/35mL; mg/35mL; mg/35mL 51346-206_52a08bd7-9ba8-4233-babb-eea806374bfc 51346-206 HUMAN OTC DRUG PROVENCE TWO WAY PACT SPF50PLUS PA PLUS PLUS PLUS 01 LIGHT BEIGE Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .72; 1.39; .35 g/12g; g/12g; g/12g 51346-207_bb824986-1cf3-4f75-bc31-11138e90228c 51346-207 HUMAN OTC DRUG PROVENCE TWO WAY PACT SPF50PLUS PA PLUS PLUS PLUS 02 NATURAL BEIGE Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .72; 1.39; .35 g/12g; g/12g; g/12g 51346-208_568e0f98-1f01-4aee-bcc7-7b27636cc840 51346-208 HUMAN OTC DRUG UV LOCK FLOWER DAILY POWERFUL SUN SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, Titanium Dioxide, AVOBENZONE, OCTISALATE, Octocrylene CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 1.25; 3.75; 1; 1; 2.12 mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL 51346-209_36df13ef-d0eb-4774-950f-9b8b574512a7 51346-209 HUMAN OTC DRUG UV LOCK FLOWER 3 PROOF SUN SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, OCTISALATE, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 3.75; 2.5; 1.45; 2.45 mg/50mL; mg/50mL; mg/50mL; mg/50mL 51346-210_45d17f65-3e7f-48c7-80fd-ac8d968aa52f 51346-210 HUMAN OTC DRUG UV LOCK FLOWER MILD SUN SPF35 PA PLUS PLUS OCTINOXATE, Titanium Dioxide, Octocrylene, AVOBENZONE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. AVOBENZONE; OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE .6; 3.75; 1; 1.06 mg/50mL; mg/50mL; mg/50mL; mg/50mL 51346-211_c25ed23d-9124-4bc4-b7c7-42e9d9b87254 51346-211 HUMAN OTC DRUG UV LOCK FLOWER SUN SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, Titanium Dioxide, OCTISALATE SPRAY TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 2.21; 1.47; 2.18 mg/150mL; mg/150mL; mg/150mL 51346-212_8c84b705-8735-4c7d-bedd-c66dba9d5a19 51346-212 HUMAN OTC DRUG UV LOCK FLOWER NON CHEMICAL SUN SPF50PLUS PA PLUS PLUS PLUS ZINC OXIDE, TITANIUM DIOXIDE LIQUID TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1; 6.24 mg/50mL; mg/50mL 51346-213_602e7e4e-af74-43d6-bc26-cc3eef456b51 51346-213 HUMAN OTC DRUG UV LOCK FLOWER PACT SUN SPF50PLUS PA PLUS PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .24; .61; .23 g/8g; g/8g; g/8g 51346-214_bb5f883b-755d-4a02-af69-a7cbc7c2b9b8 51346-214 HUMAN OTC DRUG UV LOCK FLOWER WATER GEL SUN SPF30 PA PLUS PLUS OCTINOXATE, OCTISALATE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE 4.8; 2.4 mg/80mL; mg/80mL 51346-215_9af05eab-8986-4711-86f7-0f9c5d594d21 51346-215 HUMAN OTC DRUG SUPER ORIGIN CC SPF25 PA PLUS PLUS BRIGHTENING OCTINOXATE, OCTISALATE, Titanium Dioxide, AVOBENZONE, Homosalate, Octocrylene CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE .99; .9; 3.28; 2.02; .45; 1.74 g/45g; g/45g; g/45g; g/45g; g/45g; g/45g 51346-216_77b8667c-4b4f-40a2-84a7-71e4c590a411 51346-216 HUMAN OTC DRUG SUPER ORIGIN CC SPF30 PA PLUS PLUS TINTED OCTINOXATE, Titanium Dioxide, OCTISALATE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.01; 1.12; 1.73 g/45g; g/45g; g/45g 51346-217_778b9ba4-b542-40d5-b16d-15d3ee9e0cbf 51346-217 HUMAN OTC DRUG SUPER ORIGIN CC SPF30 PA PLUS PLUS COLOR CHANGE TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.7; .9; 2.86; .86 g/45g; g/45g; g/45g; g/45g 51346-218_beb8a61f-0223-4fb0-8f58-c82ff481d4dd 51346-218 HUMAN OTC DRUG ORIGINAL POWER REFIRMING AMPOULE Allantoin LIQUID TOPICAL 20130201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. ALLANTOIN .6 mg/30mL 51346-219_cd6fd639-16ad-44d2-9d6c-754a2ae0d9d4 51346-219 HUMAN OTC DRUG ORIGINAL POWER WHITENING AND LINELESS AMPOULE ALLANTOIN LIQUID TOPICAL 20130201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. ALLANTOIN .54 mg/30mL 51346-220_3f9c16e6-0e3d-44ff-8163-7c565f1b7ebf 51346-220 HUMAN OTC DRUG HAND AND NATURE SANITIZER PEONY Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-221_d13b5973-0576-462f-b108-33c65136e7c7 51346-221 HUMAN OTC DRUG HAND AND NATURE SANITIZER ROSE Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-222_ac15b1e3-bcc1-450c-887d-7ebbf370b9b0 51346-222 HUMAN OTC DRUG HAND AND NATURE SANITIZER CAMELLIA Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-223_f46df080-d6cf-4d20-8278-ef1d13dfbdc0 51346-223 HUMAN OTC DRUG HAND AND NATURE SANITIZER TOMATO Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-224_a5e90bbe-2a69-498a-a4af-76fc3958bbc4 51346-224 HUMAN OTC DRUG HAND AND NATURE SANITIZER RASPBERRY Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-225_93a91172-4e3e-4010-97e4-4a381b1c196e 51346-225 HUMAN OTC DRUG HAND AND NATURE SANITIZER PEPPERMINT Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-226_895a81ae-f64d-4eeb-bb64-399661abcde5 51346-226 HUMAN OTC DRUG HAND AND NATURE SANITIZER AVOCADO Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-227_195513d1-a88f-4c64-894e-3515fd332973 51346-227 HUMAN OTC DRUG HAND AND NATURE SANITIZER GRAPE Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-228_9c93f4d2-11a7-4be3-8794-39733c25b73c 51346-228 HUMAN OTC DRUG HAND AND NATURE SANITIZER LAVENDER Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-229_34aff21f-bf53-4b33-85db-6577fcf4869b 51346-229 HUMAN OTC DRUG HAND AND NATURE SANITIZER ROSEMARY Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-230_4d00de45-be52-478f-a2da-51f5cd6a17ba 51346-230 HUMAN OTC DRUG HAND AND NATURE SANITIZER GREEN TEA Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-231_bb57f259-83f9-40ef-b9d8-f10e84b4cc79 51346-231 HUMAN OTC DRUG HAND AND NATURE SANITIZER KIWI Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-232_376e2e7a-781e-4d3a-9a12-55aacf77de87 51346-232 HUMAN OTC DRUG HAND AND NATURE SANITIZER ALMOND Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-233_3abbcad2-45f5-4c5c-bc14-b70dff9719a4 51346-233 HUMAN OTC DRUG HAND AND NATURE SANITIZER APPLE Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-234_f073fc45-0071-446a-a018-8457045f20ba 51346-234 HUMAN OTC DRUG HAND AND NATURE SANITIZER ALOE Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-235_80f5977d-fa44-4f7d-ad6c-f5b3e5a0a4ba 51346-235 HUMAN OTC DRUG HAND AND NATURE SANITIZER LEMON Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-236_6f3b2040-de09-452b-89e8-f46ab01a5918 51346-236 HUMAN OTC DRUG HAND AND NATURE SANITIZER PEACH Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-237_40974335-f247-4a7a-bcec-3abb3348d546 51346-237 HUMAN OTC DRUG HAND AND NATURE SANITIZER ORANCE Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-238_c262932d-3110-477a-9d1d-e8544528686a 51346-238 HUMAN OTC DRUG HAND AND NATURE SANITIZER GRAPEFRUIT Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-239_caa9c4a2-8bb8-48ef-a1cf-fd3afe9ea207 51346-239 HUMAN OTC DRUG HAND AND NATURE SANITIZER CALENDULA Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL 51346-240_3e860f74-0b99-4d60-955a-f643d1e32123 51346-240 HUMAN OTC DRUG CALIFORNIA ALOE MILD SUN BLOCK OCTINOXATE, Titanium Dioxide, AVOBENZONE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. AVOBENZONE; OCTINOXATE; TITANIUM DIOXIDE .75; 3.5; 1.06 mg/50mL; mg/50mL; mg/50mL 51346-241_f2158f1b-d396-4e97-be0b-1e13c77d931d 51346-241 HUMAN OTC DRUG CALIFORNIA ALOE DAILY MOISTURE SUN BLOCK OCTINOXATE, Titanium Dioxide, AVOBENZONE, OCTISALATE, Octocrylene CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 1.25; 3.75; 1; 1; 2.21 mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL 51346-242_adcf28d4-0a5f-4788-9e1c-827aa2e5b154 51346-242 HUMAN OTC DRUG CALIFORNIA ALOE POWER LASTING SUN BLOCK OCTINOXATE, Zinc Oxide, OCTISALATE, Titanium Dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 3.5; 2.25; 1.45; 2.45 mg/50mL; mg/50mL; mg/50mL; mg/50mL 51346-243_267b3758-e7de-4ddf-83fb-b2c5c0b8c99f 51346-243 HUMAN OTC DRUG CALIFORNIA ALOE OIL FREE SUN BLOCK OCTINOXATE, OCTISALATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE 4.8; 2.4 mg/80mL; mg/80mL 51346-244_f48d56d9-25fa-49b3-b6be-ff8027181215 51346-244 HUMAN OTC DRUG CALIFORNIA ALOE FRESH SUN MILK Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1; 6.24 mg/50mL; mg/50mL 51346-245_424a81cf-8bb4-4ac4-9347-6cec1f84855b 51346-245 HUMAN OTC DRUG CALIFORNIA ALOE POWER LASTING SUN OCTINOXATE, OCTISALATE SPRAY TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE 3.15; 1.8 mg/150mL; mg/150mL 51346-246_3aa9044d-4807-40c0-9a39-cdeb845829f5 51346-246 HUMAN OTC DRUG CALIFORNIA ALOE POWER LASTING SUN BLOCK OCTINOXATE, Zinc Oxide, OCTISALATE, Titanium Dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 4.5; 2.91; 4.9 mg/100mL; mg/100mL; mg/100mL; mg/100mL 51346-247_a6db00ba-0108-4592-81f2-2f9b85a6ef99 51346-247 HUMAN OTC DRUG BY FLOWER BB 01 LIGHT BEIGE Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 1.4; 3.15 mg/35mL; mg/35mL 51346-248_31e3c568-a721-43bc-bc0d-b4de264ee626 51346-248 HUMAN OTC DRUG BY FLOWER BB 02 NATURAL BEIGE Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 1.4; 3.15 mg/35mL; mg/35mL 51346-249_77b3ebc0-bee6-443e-b620-6d49f0137e5e 51346-249 HUMAN OTC DRUG SUPER ORIGIN COLLAGEN BB Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.35; 2.87; .86 g/45g; g/45g; g/45g 51346-250_18ff9a4d-905b-4897-9de9-0ceaf4efeb72 51346-250 HUMAN OTC DRUG SUPER ORIGIN CERAMIDE BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 5.14; .65 g/45g; g/45g 51346-251_4d52d5a7-dd56-45b6-8ac0-168f13e27560 51346-251 HUMAN OTC DRUG SUPER ORIGIN COLLAGEN WATERPROOF BB Titanium Dioxide, OCTINOXATE, Zinc Oxide, OCTISALATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 3.15; 1.35; 4.58; 2.2 g/45g; g/45g; g/45g; g/45g 51346-252_ad1e0292-24ef-4687-bf0d-2c2fda7f6c3f 51346-252 HUMAN OTC DRUG BOTANICAL VANILLA FOUNDATION 21 VANILLA NUDE Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 1.4; 2.92 g/35g; g/35g 51346-253_03a3f7a3-111f-4d40-979d-67453412762c 51346-253 HUMAN OTC DRUG BOTANICAL VANILLA FOUNDATION 23 VANILLA NATURAL Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 1.4; 2.92 g/35g; g/35g 51346-254_ceb8e785-ad10-44a0-ad23-9757bde888f4 51346-254 HUMAN OTC DRUG BOTANICAL VANILLA MAKEUP BASE 01 VANILLA GREEN Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .7; 1.76 g/35g; g/35g 51346-255_f0036aee-fb81-41bf-a296-857aa8aa72be 51346-255 HUMAN OTC DRUG BOTANICAL VANILLA MAKEUP BASE 02 VANILLA PINK Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .7; 1.76 g/35g; g/35g 51346-256_eb4584d5-3096-4523-8136-07a3f17701b2 51346-256 HUMAN OTC DRUG CELL BOOSTING BB 01 LIGHT BEIGE Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.14; 3.31; .72 g/38g; g/38g; g/38g 51346-257_cc50ff17-b218-4417-83d9-50315eb1c1a6 51346-257 HUMAN OTC DRUG CELL BOOSTING BB 02 NATURAL BEIGE Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.14; 3.31; .72 g/38g; g/38g; g/38g 51346-258_137afd72-5667-414c-b3ac-384be412341a 51346-258 HUMAN OTC DRUG CELL BOOSTING BB 03 SAND BEIGE Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.14; 3.31; .72 g/38g; g/38g; g/38g 51346-259_89079782-d4f3-4cb8-b4c7-746e17b47dac 51346-259 HUMAN OTC DRUG SUPER ORIGIN CUSHION COMPLETE CONTROL 21 MOIST AND BRIGHT SKIN Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .96; .86 g/21; g/21; g/21 51346-260_7542d7f6-742e-443d-ad75-6fc5b450683b 51346-260 HUMAN OTC DRUG SUPER ORIGIN CUSHION COMPLETE CONTROL 23 MOIST AND NATURAL SKIN Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; 1.22; .87 g/21; g/21; g/21 51346-261_ec206b3d-4f77-4f97-bdd4-d6dbaf93f5af 51346-261 HUMAN OTC DRUG SUPER ORIGIN COTTON FINISH FOUNDATION 21 LIGHT BEIGE Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; 3.05; .57 mg/30mL; mg/30mL; mg/30mL 51346-262_8c498dce-a59a-475f-a8b7-27d4368df0bd 51346-262 HUMAN OTC DRUG SUPER ORIGIN COTTON FINISH FOUNDATION 23 NATURAL BEIGE Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; 3.05; .57 mg/30mL; mg/30mL; mg/30mL 51350-005_ded8ab1d-4ff4-422e-95e5-0582e06888e4 51350-005 HUMAN OTC DRUG Relovox Renewing Clarifying Cleanser EMULSION TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333D Transdermal Corp BENZOYL PEROXIDE 25 mg/g 51350-010_cb50ca0f-6395-4101-886b-8e4c027c537d 51350-010 HUMAN OTC DRUG curacaine Transdermal Corporation Lidocaine CREAM TOPICAL 20120912 OTC MONOGRAPH NOT FINAL part348 Transdermal Corp LIDOCAINE 40 mg/mL 51350-111_fde0012f-0f00-4d01-b3fc-2eabb4061dea 51350-111 HUMAN OTC DRUG Cutiecaine Topical Lidocaine (5% w/w) CREAM TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part348 Transdermal Corp LIDOCAINE HYDROCHLORIDE 50 mg/g 51352-010_2cec86d7-04cb-45bb-b9b3-517157e7fd30 51352-010 HUMAN OTC DRUG Pancold S Oral Acetaminophen, Guaifenesin LIQUID ORAL 20141101 OTC MONOGRAPH FINAL part341 Dong Wha Pharm. Co., Ltd. ACETAMINOPHEN; GUAIFENESIN 30; 2.77 mg/301; mg/301 51362-1677_359ef24d-379e-48ca-982c-40cdad5ee1aa 51362-1677 HUMAN OTC DRUG Blockout Foot Wipes Alcohol CLOTH TOPICAL 20100815 OTC MONOGRAPH FINAL part358 Ideas Born to Succeed ALCOHOL 1 ug/mL 51362-6788_359ef24d-379e-48ca-982c-40cdad5ee1aa 51362-6788 HUMAN OTC DRUG Blockout Foot Wipes Alcohol CLOTH TOPICAL 20100920 OTC MONOGRAPH FINAL part358 Ideas Born to Succeed ALCOHOL 1 ug/mL 51367-001_0d44fd9c-7d9a-4878-869f-c6cf9bc6e08e 51367-001 HUMAN OTC DRUG Yat Tip Xiao Salicylic Acid PLASTER TOPICAL 19770101 OTC MONOGRAPH FINAL part358F Internationa Nature Nutraceuticals, Inc SALICYLIC ACID 156 mg/1 51367-002_b585ed68-598a-4953-a527-fb63ae7d1dfe 51367-002 HUMAN OTC DRUG Cold Remedy Soothing Chlorpheniramine Maleate, Acetaminophen TABLET ORAL 19870224 OTC MONOGRAPH FINAL part341 International Nature Nutraceuticals ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 105; 1.05 mg/1; mg/1 51367-003_10e18bd4-597f-471e-87bb-66bf88d3e9d0 51367-003 HUMAN OTC DRUG Shao Lin Gao Pain Relieving Plaster Camphor, Menthol, Methyl Salicylate PLASTER TOPICAL 19811102 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 21.21; 14.14; 64.45 mg/1; mg/1; mg/1 51367-004_dd369060-c05b-43c0-85a9-d9ea923937a5 51367-004 HUMAN OTC DRUG Yao Shen Gao Pain Relieving Plaster Camphor, Menthol, Methyl Salicylate PLASTER TOPICAL 19850629 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 43.76; 37.02; 72.39 mg/1; mg/1; mg/1 51367-005_d0a8f2c8-a3d5-4cac-b9bf-c4d8df7e2485 51367-005 HUMAN OTC DRUG Cold Remedy Gan Mao Ling Caffeine, Chlorpheniramine Maleate, Acetaminophen TABLET ORAL 20030728 OTC MONOGRAPH FINAL part341 International Nature Nutraceuticals ACETAMINOPHEN; CAFFEINE; CHLORPHENIRAMINE MALEATE 50; 1; 1 mg/1; mg/1; mg/1 51367-006_d973c827-3855-4b59-a199-a3fa34cf3ac6 51367-006 HUMAN OTC DRUG Fengliaoxing Fengshi Dieda Yaojiu Alcohol LIQUID TOPICAL 20010615 OTC MONOGRAPH NOT FINAL part333E International Nature Nutraceuticals ALCOHOL 128.21 g/1 51367-007_82c3a193-0d47-4406-b322-1bf831061da7 51367-007 HUMAN OTC DRUG Yu Long You Pain Relieving Camphor, Menthol, Methyl Salicylate LOTION TOPICAL 20030701 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 3.97; 1.78; 7.04 g/1; g/1; g/1 51367-008_8b3659b3-c0cb-4626-a8a4-90a4107b7ca3 51367-008 HUMAN OTC DRUG Pi Yen Chin Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19850701 OTC MONOGRAPH FINAL part349 International Nature Nutraceuticals NAPHAZOLINE HYDROCHLORIDE 1 mg/1 51367-009_59910d36-ebbf-4a68-9fd1-ad6d724f408e 51367-009 HUMAN OTC DRUG Glycerin Liquid Laxative Enema(Kaisalilu) Glycerin LIQUID RECTAL 19920705 OTC MONOGRAPH NOT FINAL part334 International Nature Nutraceuticals GLYCERIN 12.5 g/1 51367-010_8de66e3b-0772-418f-9723-e0933282bf96 51367-010 HUMAN OTC DRUG Pain Relieving Balm Menthol, Camphor, Methyl Salicylate LINIMENT TOPICAL 20050501 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals, Inc. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 5.78; 6.19; 15.66 g/1; g/1; g/1 51367-011_4d7fd70f-0ef6-48cb-b6ab-b9b9d316022f 51367-011 HUMAN OTC DRUG Strain Pain Relieving Cream Menthol, Camphor, Methyl Salicylate CREAM TOPICAL 19950101 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 796.8; 854.4; 1.13 mg/1; mg/1; g/1 51367-012_baa256fb-d508-4d35-974b-0a4ba93d969c 51367-012 HUMAN OTC DRUG Wok Lok Pain Relieving Oil Camphor, Methyl Salicylate, Menthol OIL TOPICAL 19661001 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals Inc. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 3.78; 3.38; 6.69 g/1; g/1; g/1 51367-013_046fe7c3-72a1-41b7-9fef-4ec4cef696f1 51367-013 HUMAN OTC DRUG Arthritis Pain Relieving Cream Camphor, Methyl Salicylate, Menthol CREAM TOPICAL 19930901 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals, Inc. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 7.3; 8.76; 10.95 g/1; g/1; g/1 51367-014_566ddf02-c8df-4217-aa60-767010a8e2be 51367-014 HUMAN OTC DRUG Back Pain Relieving Oil Camphor, Methyl Salicylate, Menthol OIL TOPICAL 19660901 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 3.49; 3.92; 7.98 g/1; g/1; g/1 51367-015_2263420f-076c-439a-a449-33c633d28a52 51367-015 HUMAN OTC DRUG Red Flower Oil Camphor, Methyl Salicylate OIL TOPICAL 19950601 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); METHYL SALICYLATE 2.09; 5.28 g/1; g/1 51367-016_15f75fe7-d049-4de6-80ac-6214bd5640a8 51367-016 HUMAN OTC DRUG Pain Relieving Po Tong Oil Camphor, Methyl Salicylate, Menthol OIL TOPICAL 19960601 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 4.64; 2.78; 14.65 g/1; g/1; g/1 51367-017_656b1873-0b92-44b9-90ec-d1f9bf54c3b2 51367-017 HUMAN OTC DRUG Pain Relieving Chi Len Oil Camphor, Methyl Salicylate, Menthol OIL TOPICAL 19950601 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 4.78; 2.23; 14.65 g/1; g/1; g/1 51367-018_57e9065a-22ec-4e10-bd5a-c431f5aa815e 51367-018 HUMAN OTC DRUG Pain Reileving Herbal Oil Camphor, Methyl Salicylate, Menthol OIL TOPICAL 19950601 OTC MONOGRAPH NOT FINAL part348 International Nature Nutracetucals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 2.99; 1.74; 9.16 1/1; 1/1; 1/1 51367-019_65c1715d-d205-4b3e-81f8-9d40db26cb72 51367-019 HUMAN OTC DRUG Zhuanggu Shexiang Zhitonggao Pain Relieving Plaster Camphor, Menthol, Methyl Salicylate PLASTER TOPICAL 19910801 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 114.29; 114.29; 85.72 mg/1; mg/1; 1/1 51367-020_d1953acd-21f8-4c31-b9ac-b23f659fdc41 51367-020 HUMAN OTC DRUG Refined Gou Pi Pain Relieving Plaster Methyl Salicylate, Camphor, Menthol PLASTER TOPICAL 19790516 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 116; 116; 120.8 mg/1; mg/1; mg/1 51367-021_4873a630-e11f-43f6-95b4-8d2354ebb67e 51367-021 HUMAN OTC DRUG Shang Shi Zhi Tong Pain Relieving Plaster Methyl Salicylate, Camphor, Menthol PLASTER TOPICAL 19760816 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 116; 116; 120.8 mg/1; mg/1; mg/1 51367-022_c5eae52b-3dec-49c0-9a13-88fa8f9330ec 51367-022 HUMAN OTC DRUG Zhuang Gu Feng Shi Pain Relieving Plaster Methyl Salicylate, Camphor, Menthol PLASTER TOPICAL 19770716 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 116; 116; 118.8 mg/1; mg/1; mg/1 51367-023_c07e57d4-b7c0-4dda-98d1-9c295154028b 51367-023 HUMAN OTC DRUG Shuang Long Pain Relieving Oil Menthol, Methyl Salicylate OIL TOPICAL 19900610 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals, Inc. MENTHOL; METHYL SALICYLATE 4.3; 9.4 g/1; g/1 51384-100_fd01c72e-b0f1-4fc7-82c6-631459c95556 51384-100 HUMAN OTC DRUG AMMENS MEDICATED ZINC OXIDE POWDER TOPICAL 20100729 OTC MONOGRAPH FINAL part347 Botanicals Internacional S.A. de C.V. ZINC OXIDE 9.1 g/100g 51386-100_4ce52085-c130-4594-b01c-a2caab187dc1 51386-100 HUMAN OTC DRUG Sheer Genius Liquid Foundation Dark Look TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20100809 OTC MONOGRAPH FINAL part352 Napoleon Perdis Cosmetics OCTINOXATE; TITANIUM DIOXIDE 2; 3.5 mL/100mL; mL/100mL 51386-200_a86ce85e-11fd-4307-a475-b244bf2a5a0a 51386-200 HUMAN OTC DRUG Sheer Genius Liquid Foundation - Extra Dark Look TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20100809 OTC MONOGRAPH FINAL part352 Napoleon Perdis Cosmetics OCTINOXATE; TITANIUM DIOXIDE 2; 3.5 mL/100mL; mL/100mL 51386-300_050ff05d-9034-4ada-aedc-1ff038cabf09 51386-300 HUMAN OTC DRUG Sheer Genius Liquid Foundation - Extra Light Look TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20100809 OTC MONOGRAPH FINAL part352 Napoleon Perdis Cosmetics OCTINOXATE; TITANIUM DIOXIDE 2; 3.5 mL/100mL; mL/100mL 51386-400_544b7587-adb4-468f-926e-94f8aece510f 51386-400 HUMAN OTC DRUG Sheer Genius Liquid Foundation - Light Look TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20100809 OTC MONOGRAPH FINAL part352 Napoleon Perdis Cosmetics OCTINOXATE; TITANIUM DIOXIDE 2; 3.5 mL/100mL; mL/100mL 51386-500_d1efb120-eef4-4f49-adff-579eaa219042 51386-500 HUMAN OTC DRUG Sheer Genius Liquid Foundation - Medium Dark Look TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20100809 OTC MONOGRAPH FINAL part352 Napoleon Perdis Cosmetics OCTINOXATE; TITANIUM DIOXIDE 2; 3.5 mL/100mL; mL/100mL 51386-600_67098cea-85b9-45a3-8fad-a9d9565bf1e9 51386-600 HUMAN OTC DRUG Sheer Genius Liquid Foundation - Medium Look TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20100809 OTC MONOGRAPH FINAL part352 Napoleon Perdis Cosmetics OCTINOXATE; TITANIUM DIOXIDE 2; 3.5 mL/100mL; mL/100mL 51386-702_c51d2610-b2e7-44ef-a6a6-9c757f0e3299 51386-702 HUMAN OTC DRUG napoleon PERDIS ADVANCED MINERAL MAKEUP BROAD SPECTRUM SPF 15 Look 2 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51386-703_2ccfee4a-0a55-4149-b59f-3fc49de18856 51386-703 HUMAN OTC DRUG napoleon PERDIS ADVANCED MINERAL MAKEUP BROAD SPECTRUM SPF 15 Look 3 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51386-704_4b4720bf-3480-4af6-943e-ce079afe3234 51386-704 HUMAN OTC DRUG napoleon PERDIS ADVANCED MINERAL MAKEUP BROAD SPECTRUM SPF 15 Look 4 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51386-705_6802b293-81e1-4bd8-b14d-b165311a80ba 51386-705 HUMAN OTC DRUG napoleon PERDIS ADVANCED MINERAL MAKEUP BROAD SPECTRUM SPF 15 Look 5 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51386-706_6711a652-60c8-407f-96f1-bb16e36d050f 51386-706 HUMAN OTC DRUG napoleon PERDIS ADVANCED MINERAL MAKEUP BROAD SPECTRUM SPF 15 Look 1 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL 51386-710_69806131-5377-4a23-aa41-e3cb0e136a4d 51386-710 HUMAN OTC DRUG napoleon PERDIS CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15 Look 2B TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 45; 29.7 mg/mL; mg/mL 51386-711_1fc49272-ffd3-436d-8bcc-7e7e0e24f9bb 51386-711 HUMAN OTC DRUG napoleon PERDIS CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15 Look 1 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 45; 29.7 mg/mL; mg/mL 51386-712_80a6dc37-dc85-4a8c-92ba-a1b6d93eef3d 51386-712 HUMAN OTC DRUG napoleon PERDIS CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15 Look 2 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 45; 29.7 mg/mL; mg/mL 51386-713_fdf84555-e301-4f25-90cb-aa6d027e62bc 51386-713 HUMAN OTC DRUG napoleon PERDIS CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15 Look 3 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 45; 29.7 mg/mL; mg/mL 51386-714_22bdabcf-e94a-4d15-b868-b8582b908a79 51386-714 HUMAN OTC DRUG napoleon PERDIS CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15 Look 4 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 45; 29.7 mg/mL; mg/mL 51386-721_c00f06ac-2d66-45a6-ab68-972c355e3ac0 51386-721 HUMAN OTC DRUG napoleon PERDIS SHEER GENIUS LIQUID FOUNDATION BROAD SPECTRUM SPF 20 Look 1 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 20; 35 mg/mL; mg/mL 51386-722_d43ca171-7a32-4311-921e-15aa298b8fcc 51386-722 HUMAN OTC DRUG napoleon PERDIS SHEER GENIUS LIQUID FOUNDATION BROAD SPECTRUM SPF 20 Look 2 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 20; 35 mg/mL; mg/mL 51386-723_50fd0b71-5b5f-4dcb-937b-0c84205efaef 51386-723 HUMAN OTC DRUG napoleon PERDIS SHEER GENIUS LIQUID FOUNDATION BROAD SPECTRUM SPF 20 Look 3 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 20; 35 mg/mL; mg/mL 51386-724_61237d66-5af3-4abb-8ac2-2564819d6cdd 51386-724 HUMAN OTC DRUG napoleon PERDIS SHEER GENIUS LIQUID FOUNDATION BROAD SPECTRUM SPF 20 Look 4 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 20; 35 mg/mL; mg/mL 51386-725_f68a1dc1-6416-4abb-9d24-5374a29a1f04 51386-725 HUMAN OTC DRUG napoleon PERDIS SHEER GENIUS LIQUID FOUNDATION BROAD SPECTRUM SPF 20 Look 5 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 20; 35 mg/mL; mg/mL 51386-726_17fe7ec6-4b38-446d-8766-323009f6b6c4 51386-726 HUMAN OTC DRUG napoleon PERDIS SHEER GENIUS LIQUID FOUNDATION BROAD SPECTRUM SPF 20 Look 6 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 20; 35 mg/mL; mg/mL 51386-731_4c3f7a16-13d7-405a-8b57-22e3ebe014a4 51386-731 HUMAN OTC DRUG napoleon PERDIS FOUNDATION STICK BROAD SPECTRUM SPF 15 Look 1 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 50; 20 mg/g; mg/g; mg/g 51386-732_5b7ec36d-3b7b-4017-8032-9f34d7ef6c03 51386-732 HUMAN OTC DRUG napoleon PERDIS FOUNDATION STICK BROAD SPECTRUM SPF 15 Look 2 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 50; 20 mg/g; mg/g; mg/g 51386-733_85278bed-4247-4060-9652-0bf63be590fa 51386-733 HUMAN OTC DRUG napoleon PERDIS FOUNDATION STICK BROAD SPECTRUM SPF 15 Look 3 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 50; 20 mg/g; mg/g; mg/g 51386-734_d64a0d69-c19d-459c-8169-1e12ef6cf3dc 51386-734 HUMAN OTC DRUG napoleon PERDIS FOUNDATION STICK BROAD SPECTRUM SPF 15 Look 4 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 50; 20 mg/g; mg/g; mg/g 51386-735_1fc1a155-66df-45ca-a238-f4f9cd85fc1a 51386-735 HUMAN OTC DRUG napoleon PERDIS FOUNDATION STICK BROAD SPECTRUM SPF 15 Look 2B OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 50; 20 mg/g; mg/g; mg/g 51386-736_5bcae033-418b-45d4-91b8-9264deef0f05 51386-736 HUMAN OTC DRUG napoleon PERDIS FOUNDATION STICK BROAD SPECTRUM SPF 15 Look 3B OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 50; 20 mg/g; mg/g; mg/g 51386-737_8b0806e4-f0d3-421b-a147-a195ccbb8331 51386-737 HUMAN OTC DRUG napoleon PERDIS FOUNDATION STICK BROAD SPECTRUM SPF 15 Look 5B OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 50; 20 mg/g; mg/g; mg/g 51386-740_c57f81cc-01be-4449-bb6f-08e8e77a6324 51386-740 HUMAN OTC DRUG napoleon PERDIS AUTO PILOT BBB CREAM BROAD SPECTRUM SPF 30 LIGHT-MEDIUM ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 61.4; 69 mg/mL; mg/mL; mg/mL 51386-741_be11b7a3-de3e-47ae-94c3-219e06cd9a44 51386-741 HUMAN OTC DRUG napoleon PERDIS AUTO PILOT BBB CREAM BROAD SPECTRUM SPF 30 MEDIUM-DARK ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 61.4; 69 mg/mL; mg/mL; mg/mL 51386-750_47c885fb-e893-4fa4-b9cf-fa9eaeeb231a 51386-750 HUMAN OTC DRUG NP set BB CREAM Broad Spectrum SPF 20 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL 51389-101_93c34ee2-2d47-4beb-8634-c62ff548464d 51389-101 HUMAN OTC DRUG balance-n-brighten FAIR TITANIUM DIOXIDE POWDER TOPICAL 20111113 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. TITANIUM DIOXIDE 10 g/100g 51389-102_95ac6c91-f111-4cb9-945b-48acd458f4a1 51389-102 HUMAN OTC DRUG balance-n-brighten Porcelain TITANIUM DIOXIDE POWDER TOPICAL 20111113 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. TITANIUM DIOXIDE 10 g/100g 51389-103_9c98ebf8-31ec-4fac-a502-5103a8f38395 51389-103 HUMAN OTC DRUG balance-n-brighten Regular TITANIUM DIOXIDE POWDER TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. TITANIUM DIOXIDE 10 g/100g 51389-104_9393b3ae-22a4-4548-8041-59572c9978d7 51389-104 HUMAN OTC DRUG balance-n-brighten TAN TITANIUM DIOXIDE POWDER TOPICAL 20111113 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. TITANIUM DIOXIDE 10 g/100g 51389-105_6ee381ff-446c-469c-b362-32eeb829b56a 51389-105 HUMAN OTC DRUG bronze-n-brighten FAIR TITANIUM DIOXIDE POWDER TOPICAL 20111113 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. TITANIUM DIOXIDE 10 g/100g 51389-106_565b3d2a-aa2a-4838-b572-22258f617df4 51389-106 HUMAN OTC DRUG bronze-n-brighten REGULAR TITANIUM DIOXIDE POWDER TOPICAL 20111113 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. TITANIUM DIOXIDE 10 g/100g 51389-107_70ca128b-e454-4bc5-8688-49448f1a10e0 51389-107 HUMAN OTC DRUG Real Deal Foundation DEEP TITANIUM DIOXIDE STICK TOPICAL 20111113 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7; 3; 5 g/100g; g/100g; g/100g 51389-108_1c0bf028-e240-4667-887b-7a7695196fe1 51389-108 HUMAN OTC DRUG Real Deal Foundation FAIR TITANIUM DIOXIDE STICK TOPICAL 20111113 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7; 3; 5 g/100g; g/100g; g/100g 51389-109_edb95fc8-fad8-4982-abe6-e64912d26d78 51389-109 HUMAN OTC DRUG Real Deal Foundation LIGHT TITANIUM DIOXIDE STICK TOPICAL 20111113 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7; 3; 5 g/100g; g/100g; g/100g 51389-110_07f9890d-1a3d-4d1b-918e-f562791983f9 51389-110 HUMAN OTC DRUG Real Deal Foundation MEDIUM TITANIUM DIOXIDE STICK TOPICAL 20111113 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7; 3; 5 g/100g; g/100g; g/100g 51389-111_c29c43c4-85ca-4e18-8e80-eb0bc7cd20cd 51389-111 HUMAN OTC DRUG Real Deal Foundation MEDIUM DEEP TITANIUM DIOXIDE STICK TOPICAL 20111113 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7; 3; 5 g/100g; g/100g; g/100g 51389-112_a72aa9c0-f8dc-45db-8999-b5c886b6ae97 51389-112 HUMAN OTC DRUG Ethereal Rose SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20120306 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC TITANIUM DIOXIDE 10 g/100g 51389-113_b0f2a90e-77da-4c7c-8db1-87d908b4d4dc 51389-113 HUMAN OTC DRUG take cover anti-aging foundation FAIR OCTINOXATE CREAM TOPICAL 20120608 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.5; 1.95 g/100g; g/100g; g/100g 51389-114_fb53a4d6-7a60-44b9-a661-d2fcd57d41ab 51389-114 HUMAN OTC DRUG take cover anti-aging foundation LIGHT OCTINOXATE CREAM TOPICAL 20120608 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.5; 1.95 g/100g; g/100g; g/100g 51389-115_5499c7cb-1144-436d-9099-d34b6e37928a 51389-115 HUMAN OTC DRUG take cover anti-aging foundation MEDIUM OCTINOXATE CREAM TOPICAL 20120608 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.5; 1.95 g/100g; g/100g; g/100g 51389-116_f2d935e6-ffb2-4457-acec-5db19e34289c 51389-116 HUMAN OTC DRUG take cover anti-aging foundation MEDIUM RICH OCTINOXATE CREAM TOPICAL 20120608 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.5; 1.95 g/100g; g/100g; g/100g 51389-117_3054dbb2-c8c5-480a-aee3-cbde6081c523 51389-117 HUMAN OTC DRUG take cover anti-aging foundation MEDIUM DEEP OCTINOXATE CREAM TOPICAL 20120608 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.5; 1.95 g/100g; g/100g; g/100g 51389-118_dd00f7d5-3cf1-4f45-b413-100c304d6143 51389-118 HUMAN OTC DRUG take cover anti-aging foundation DEEP OCTINOXATE CREAM TOPICAL 20120614 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.5; 1.95 g/100g; g/100g; g/100g 51389-119_c7117dc3-2c86-4b23-8a89-a4b91e59ecd8 51389-119 HUMAN OTC DRUG color correcting swirl foundation broad spectrum SPF 25 LIGHT OCTOCRYLENE AVOBENZONE OCTISALATE CREAM TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 51389-120_f601318f-24db-4b16-a140-4a2e933d19bf 51389-120 HUMAN OTC DRUG color correcting swirl foundation broad spectrum SPF 25 MEDIUM OCTOCRYLENE AVOBENZONE OCTISALATE CREAM TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 51389-121_607cf3ce-1d5c-41c8-8d73-7b66b6c433c3 51389-121 HUMAN OTC DRUG color correcting swirl foundation broad spectrum SPF 25 TAN OCTOCRYLENE AVOBENZONE OCTISALATE CREAM TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 51389-122_bdbe3d7c-ae26-48c2-a439-5a36b204c3fb 51389-122 HUMAN OTC DRUG LAURA GELLER BEAUTY SUN KISSED COLOR LIP BALM TRIO BROAD SPECTRUM SPF 15 Pink - Coral - Berry OCTISALATE, AVOBENZONE, OCTINOXATE, OCTOCRYLENE KIT 20131209 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. 51389-200_83a65b89-3ec7-4349-aca8-63ad595e026e 51389-200 HUMAN OTC DRUG LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER PORCELAIN AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140310 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL 51389-201_d7d456f1-5e1e-4619-84a5-7b001e7413da 51389-201 HUMAN OTC DRUG LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER FAIR AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140310 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL 51389-202_7b64863e-d932-482a-8379-2bd94644bac1 51389-202 HUMAN OTC DRUG LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140310 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL 51389-203_b16c9f16-dea4-4310-8664-f204987f9fc4 51389-203 HUMAN OTC DRUG LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER TAN AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140310 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL 51389-204_891d1a24-23b1-4e3d-a040-f398e1ca652e 51389-204 HUMAN OTC DRUG LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER DEEP AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140310 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL 51389-210_4c12ba8c-6b31-4141-9232-e89fc4c620b6 51389-210 HUMAN OTC DRUG LAURA GELLER spackle Broad Spectrum SPF 30 protective under make-up primer AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140514 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL 51389-250_6f7ab312-f3dd-47c6-aca0-d358b4321385 51389-250 HUMAN OTC DRUG skin elements liquid veil foundation broad spectrum SPF 25 PORCELAIN OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20140321 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE 27; 50; 40 mg/mL; mg/mL; mg/mL 51389-251_c3964561-2c02-41b9-9129-61ccf0e77f6b 51389-251 HUMAN OTC DRUG skin elements liquid veil foundation broad spectrum SPF 25 LIGHT OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20140321 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE 27; 50; 40 mg/mL; mg/mL; mg/mL 51389-252_5d93ca40-8374-46c6-a9dc-eb4015bf4aab 51389-252 HUMAN OTC DRUG skin elements liquid veil foundation broad spectrum SPF 25 MEDIUM OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20140321 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE 27; 50; 40 mg/mL; mg/mL; mg/mL 51389-253_30789218-1e08-469f-be94-61e9f83f196e 51389-253 HUMAN OTC DRUG skin elements liquid veil foundation broad spectrum SPF 25 GOLDEN MEDIUM OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20140321 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE 27; 50; 40 mg/mL; mg/mL; mg/mL 51389-254_66eddd8a-7072-4a59-aa7a-8f30dbcdd173 51389-254 HUMAN OTC DRUG skin elements liquid veil foundation broad spectrum SPF 25 TAN OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20140321 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE 27; 50; 40 mg/mL; mg/mL; mg/mL 51389-255_b79f2f73-7f87-47af-b45f-d7f7c9a54f60 51389-255 HUMAN OTC DRUG skin elements liquid veil foundation broad spectrum SPF 25 DEEP OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20140321 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE 27; 50; 40 mg/mL; mg/mL; mg/mL 51393-4001_bed5c421-dc48-4e6d-bb7a-aeca3b588f33 51393-4001 HUMAN OTC DRUG Age Spot Control Thuja occidentalis leafy twig SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature THUJA OCCIDENTALIS LEAFY TWIG 10 [hp_X]/100mL 51393-4004_897e577e-49f5-463a-88ce-1b9b1cc5c2a8 51393-4004 HUMAN OTC DRUG Dark Circle Arnica Montana, Milk Thistle, and Berberis Vulgaris Fruit SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature ARNICA MONTANA; BERBERIS VULGARIS FRUIT; MILK THISTLE 12; 6; 10 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 51393-4006_2dd07322-c50a-48f0-b56a-c7a340e037da 51393-4006 HUMAN OTC DRUG ROSACEA THUJA OCCIDENTALIS LEAFY TWIG SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature THUJA OCCIDENTALIS LEAFY TWIG 8 [hp_X]/1000mL 51393-4007_e6905a99-f236-4c50-b14b-7c6759789862 51393-4007 HUMAN OTC DRUG Scabies Control THUJA OCCIDENTALIS LEAF SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature THUJA OCCIDENTALIS LEAF 12 [hp_X]/100mL 51393-4008_48f0d7a5-575f-4fa5-8358-6ce511ae61b5 51393-4008 HUMAN OTC DRUG Scalp Dermatitis URTICA DIOICA SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature URTICA DIOICA 6 [hp_C]/1000mL 51393-4009_ec58ee67-5da5-4252-a3a8-0215e0d36b0e 51393-4009 HUMAN OTC DRUG Muscle Pain Arnica Montana, Horse Chestnut, Hypericum Perforatum, Ruta Graveolens Flowering Top, and Thuja Occidentalis Leafy Twig SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature ARNICA MONTANA; HORSE CHESTNUT; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG 30; 6; 12; 30; 6 [hp_C]/1000mL; [hp_C]/1000mL; [hp_C]/1000mL; [hp_C]/1000mL; [hp_X]/1000mL 51393-4010_3e580f1d-f7ef-4fff-8973-cf4c8b1d3b54 51393-4010 HUMAN OTC DRUG Stretch Mark Control Calendula Officinalis Flower, Hydrated Silica, and Allylthiourea SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature ALLYLTHIOUREA; CALENDULA OFFICINALIS FLOWER; HYDRATED SILICA 8; 6; 6 [hp_C]/100mL; [hp_X]/100mL; [hp_X]/100mL 51393-4012_089852c9-4482-45d0-a85d-d4fa7d0a79fe 51393-4012 HUMAN OTC DRUG Wrinkle Control THUJA OCCIDENTALIS LEAF SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature THUJA OCCIDENTALIS LEAF 6 [hp_X]/100mL 51393-4013_0cefa5c3-e449-4a1e-a2f0-83ae0c02b718 51393-4013 HUMAN OTC DRUG Skin Tags Thuja Occidentalis Leafy Twig and Calendula Officinalis Whole SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS WHOLE; THUJA OCCIDENTALIS LEAFY TWIG 6; 6 [hp_X]/100mL; [hp_X]/100mL 51393-5622_2aab0067-d44a-4bd4-8021-194135f07c23 51393-5622 HUMAN OTC DRUG Eczema Control Centella Asiatica, Iris Versicolor Root, Arctium Lappa Root, Sodium Chloride, Ruta Graveolens Flowering Top, Silicon Dioxide, Taraxacum Officinale, and Thuja Occidentalis Root SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature ARCTIUM LAPPA ROOT; CENTELLA ASIATICA; IRIS VERSICOLOR ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SODIUM CHLORIDE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS ROOT 12; 12; 12; 12; 6; 12; 6; 8 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_C]/100mL; [hp_X]/1000mL 51393-6111_2f488ebc-148b-4f8e-a8aa-d687b29ae91c 51393-6111 HUMAN OTC DRUG Acne Care CALENDULA OFFICINALIS FLOWERING TOP, GERANIUM MACULATUM ROOT, and Silicon Dioxide SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; GERANIUM MACULATUM ROOT; SILICON DIOXIDE 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6112_a4591b8b-e3f4-49f4-863c-2ee74152d9ba 51393-6112 HUMAN OTC DRUG Acne/Pimple Control CALENDULA OFFICINALIS FLOWERING TOP and SILICON DIOXIDE SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE 6; 6 [hp_X]/1000mL; [hp_X]/1000mL 51393-6113_cf32e409-fe6a-4162-b1b4-0407625a33dc 51393-6113 HUMAN OTC DRUG Acne/Pimple Cleanse Silicon Dioxide and Calendula Officinalis Flowering Top SOAP TOPICAL 20130915 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE 6; 6 [hp_X]/100g; [hp_X]/100g 51393-6222_deb4d864-325a-4cfa-8830-ef36c54ff9ca 51393-6222 HUMAN OTC DRUG Eczema Control Chamomile, Graphite, and Hypericum Perforatum SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CHAMOMILE; GRAPHITE; HYPERICUM PERFORATUM 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6333_107f54f8-86f3-4dcb-a3b4-72cbcb689941 51393-6333 HUMAN OTC DRUG Fissure Control Aloe, CALENDULA OFFICINALIS FLOWERING TOP, Hamamelis virginiana Root Bark/Stem Bark, and Lycopodium clavatum Spore SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature ALOE; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LYCOPODIUM CLAVATUM SPORE 6; 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6334_ddefdf9c-01b3-4dba-b315-8a467c4a28dd 51393-6334 HUMAN OTC DRUG Fissure Control CALENDULA OFFICINALIS FLOWERING TOP and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 6; 6 [hp_X]/1000mL; [hp_X]/1000mL 51393-6444_5d9c71ea-a88f-480f-936e-aeb2640f5d96 51393-6444 HUMAN OTC DRUG Hemorrhoid Control Aloe, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, and Lycopodium clavatum Spore SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature ALOE; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LYCOPODIUM CLAVATUM SPORE 6; 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6445_9a533ffb-dbef-4c14-ad96-9cbfefa24a74 51393-6445 HUMAN OTC DRUG Hemorrhoid Control Extra Strength Aloe, CALENDULA OFFICINALIS FLOWERING TOP, Hamamelis virginiana Root Bark/Stem Bark, Lycopodium clavatum Spore, Chamomile, and Geranium Maculatum Root SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature ALOE; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; GERANIUM MACULATUM ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LYCOPODIUM CLAVATUM SPORE 8; 8; 8; 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6446_b8d485ed-0c34-473f-a5c6-99939f4504ef 51393-6446 HUMAN OTC DRUG Hemorrhoid Control HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK and HORSE CHESTNUT SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT 6; 6 [hp_X]/1000mL; [hp_X]/1000mL 51393-6447_8a2e56ad-9376-446b-af34-1de79b91f693 51393-6447 HUMAN OTC DRUG Hemorrhoid Control Extra Strength Hamamelis Virginiana Root Bark/Stem Bark and Horse Chestnut SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT 8; 8 [hp_X]/1000mL; [hp_X]/1000mL 51393-6543_35827bd2-0e3b-4a97-82b3-c0d1b3d8bf91 51393-6543 HUMAN OTC DRUG Eczema Cleanse Iris Versicolor Root, Arctium Lappa Root, Ruta Graveolens Flowering Top, Centella Asiatica, Sodium Chloride, Silicon Dioxide, Taraxacum Officinale, and Thuja Occidentalis Leafy Twig SOAP TOPICAL 20130915 UNAPPROVED HOMEOPATHIC Forces of Nature ARCTIUM LAPPA ROOT; CENTELLA ASIATICA; IRIS VERSICOLOR ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SODIUM CHLORIDE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12; 6; 12; 6; 8 [hp_C]/100g; [hp_C]/100g; [hp_C]/100g; [hp_C]/100g; [hp_X]/100g; [hp_C]/100g; [hp_C]/100g; [hp_X]/100g 51393-6555_97b303dd-51ba-42ee-a807-aa963bf0f1b8 51393-6555 HUMAN OTC DRUG H-Balm Daily CALENDULA OFFICINALIS FLOWERING TOP, Geranium Maculatum Root, SODIUM CHLORIDE, and THUJA OCCIDENTALIS LEAFY TWIG SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; GERANIUM MACULATUM ROOT; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6557_8423b3ff-0ecc-4bdf-99b8-7904990e27f6 51393-6557 HUMAN OTC DRUG H-Balm Extra Strength CALENDULA OFFICINALIS FLOWERING TOP, Geranium Maculatum Root, SODIUM CHLORIDE, THUJA OCCIDENTALIS LEAFY TWIG, Zinc, and Echinacea angustifolia SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GERANIUM MACULATUM ROOT; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 10; 10; 10; 10; 10; 10 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6558_45cfab58-dc1b-46ff-a8c5-98bb4250c534 51393-6558 HUMAN OTC DRUG H-Balm Super Strength CALENDULA OFFICINALIS FLOWERING TOP, GERANIUM MACULATUM ROOT, SODIUM CHLORIDE, THUJA OCCIDENTALIS LEAFY TWIG, ZINC, and ECHINACEA ANGUSTIFOLIA SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GERANIUM MACULATUM ROOT; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 12; 12; 12; 12; 12; 12 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6655_67f69c94-087f-4e09-a931-24910b3c3a8a 51393-6655 HUMAN OTC DRUG H-Balm Daily CALENDULA OFFICINALIS FLOWERING TOP and Thuja occidentalis leafy twig SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6656_a9bff37d-3579-4ef6-9eb7-fbfe36adbb4f 51393-6656 HUMAN OTC DRUG H-Balm Control CALENDULA OFFICINALIS FLOWERING TOP, SODIUM CHLORIDE, and Thuja occidentalis leafy twig SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6657_58801d91-0940-434d-ae36-ad8ef5cce823 51393-6657 HUMAN OTC DRUG H-Balm Control Extra Strength CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA, SODIUM CHLORIDE, and THUJA OCCIDENTALIS LEAFY TWIG SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6658_4407cfc8-cbbe-4b5f-b6f1-3df6bf83083e 51393-6658 HUMAN OTC DRUG H-Balm Control Extreme Strength CALENDULA OFFICINALIS FLOWERING TOP, Echinacea angustifolia, SODIUM CHLORIDE, and Thuja occidentalis Leafy Twig SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6659_9a03f0c4-927c-4c64-8f80-be0443ec90d4 51393-6659 HUMAN OTC DRUG H-Balm Cleanse Sodium Chloride, Thuja Occidentalis Bark, and Calendula Officinalis Flowering Top SOAP TOPICAL 20130915 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; SODIUM CHLORIDE; THUJA OCCIDENTALIS BARK 8; 8; 8 [hp_X]/100g; [hp_X]/100g; [hp_X]/100g 51393-6666_1faec7c3-ec53-44f4-9843-e05e35694225 51393-6666 HUMAN OTC DRUG Nevi (Mole) Control CALENDULA OFFICINALIS FLOWERING TOP, PHYTOLACCA AMERICANA ROOT, SILICON DIOXIDE, and THUJA OCCIDENTALIS LEAFY TWIG SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6667_a808a3da-1b11-4ca8-96a1-dce16675e52e 51393-6667 HUMAN OTC DRUG Nevi (Mole) Control Extra Strength CALENDULA OFFICINALIS FLOWERING TOP, PHYTOLACCA AMERICANA ROOT, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIG, and GERANIUM MACULATUM ROOT SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; GERANIUM MACULATUM ROOT; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 8; 8; 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6668_723d955c-495f-48e8-bc9b-fe9c52d23319 51393-6668 HUMAN OTC DRUG Nevi (Mole) Control Extra Strength CALENDULA OFFICINALIS FLOWERING TOP, Phytolacca Americana Root, Silicon Dioxide, and Thuja occidentalis Leafy Twig SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 8; 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6669_5391015d-a252-4f1c-b465-031188a0db64 51393-6669 HUMAN OTC DRUG Wart Cleanse THUJA OCCIDENTALIS BARK, PHYTOLACCA AMERICANA ROOT, and CALENDULA OFFICINALIS FLOWERING TOP SOAP TOPICAL 20130915 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS BARK 6; 6; 6 [hp_X]/100g; [hp_X]/100g; [hp_X]/100g 51393-6777_453bd029-a59b-4c06-944e-fcf644bcac5d 51393-6777 HUMAN OTC DRUG Molluscum Control Lycopodium clavatum Spore, SODIUM CHLORIDE, and Thuja occidentalis leafy twig SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6778_3dd341b1-ae0c-4525-bed5-75713fa26392 51393-6778 HUMAN OTC DRUG Molluscum Control Thuja Occidentalis Leafy Twig and Sodium Chloride SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 6; 6 [hp_X]/1000mL; [hp_X]/1000mL 51393-6888_0bf5e454-284d-4192-b2ab-cf26c38be26c 51393-6888 HUMAN OTC DRUG Nail Fungus Control CALENDULA OFFICINALIS FLOWERING TOP, GERANIUM MACULATUM ROOT, and Silicon Dioxide SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; GERANIUM MACULATUM ROOT; SILICON DIOXIDE 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6889_4439d487-0766-41b7-a2c7-5550b9e6209f 51393-6889 HUMAN OTC DRUG Nail Fungus Control Extra Strength CALENDULA OFFICINALIS FLOWERING TOP, GERANIUM MACULATUM ROOT, HYPERICUM PERFORATUM, and SILICON DIOXIDE SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; GERANIUM MACULATUM ROOT; HYPERICUM PERFORATUM; SILICON DIOXIDE 8; 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-6987_75316100-83ee-439b-bd49-71268fb341bc 51393-6987 HUMAN OTC DRUG FUNGAL CLEANSE CALENDULA OFFICINALIS FLOWERING TOP and SILICON DIOXIDE SOAP TOPICAL 20130915 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE 6; 6 [hp_X]/100g; [hp_X]/100g 51393-6988_3d80d1e8-b1bf-4c16-8848-71dbbd2f5df4 51393-6988 HUMAN OTC DRUG Nail Fungus Control Calendula Officinalis Flowering Top and Silicon Dioxide SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE 6; 6 [hp_X]/1000mL; [hp_X]/1000mL 51393-6989_b68f11b6-d10c-48ea-aea3-a6cf258088f2 51393-6989 HUMAN OTC DRUG Nail Fungus Control Extra Strength Calendula Officinalis Flowering Top, Silicon Dioxide, and Hypericum Perforatum SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; SILICON DIOXIDE 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-7111_165baf68-b46c-4ef3-a9ba-9b765c1ac211 51393-7111 HUMAN OTC DRUG Scar Control CALENDULA OFFICINALIS FLOWERING TOP, Graphite, and Silicon Dioxide SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; GRAPHITE; SILICON DIOXIDE 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-7112_ff78cd85-71ff-411b-8938-9a7d99f482ae 51393-7112 HUMAN OTC DRUG Scar Control Calendula Officinalis Flowering Top, Allylthiourea, and Silicon Dioxide SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature ALLYLTHIOUREA; CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE 8; 6; 6 [hp_C]/100mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-7222_9c0fe309-ff5a-47fa-8e56-343988465ce8 51393-7222 HUMAN OTC DRUG Shingles Control CALENDULA OFFICINALIS FLOWERING TOP, GERANIUM MACULATUM ROOT, SODIUM CHLORIDE, and RANUNCULUS BULBOSUS SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; GERANIUM MACULATUM ROOT; RANUNCULUS BULBOSUS; SODIUM CHLORIDE 6; 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-7223_b1520ebe-ddb2-4986-b06c-6d53c0d963ad 51393-7223 HUMAN OTC DRUG Shingles Control Extra Strength CALENDULA OFFICINALIS FLOWERING TOP, Geranium Maculatum Root, SODIUM CHLORIDE, Ranunculus bulbosus, Toxicodendron pubescens leaf, and Zinc SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; GERANIUM MACULATUM ROOT; RANUNCULUS BULBOSUS; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF; ZINC 8; 8; 8; 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-7322_fb5c5ea2-e1ff-489b-8e61-f6e8eb1dec5b 51393-7322 HUMAN OTC DRUG Shingles Control CALENDULA OFFICINALIS FLOWERING TOP, HYPERICUM PERFORATUM, and SODIUM CHLORIDE SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; SODIUM CHLORIDE 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-7323_675f6a97-2d8b-443b-ae99-fa314e16aaa4 51393-7323 HUMAN OTC DRUG Shingles Control Extra Strength CALENDULA OFFICINALIS FLOWERING TOP, HYPERICUM PERFORATUM, and SODIUM CHLORIDE SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; SODIUM CHLORIDE 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-7333_bdd05197-e082-4f35-8751-fb5954466009 51393-7333 HUMAN OTC DRUG Wart Control CALENDULA OFFICINALIS FLOWERING TOP, Causticum, Phytolacca Americana Root, and Thuja occidentalis leafy twig SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-7334_fa42d2f8-833a-40cb-a5ee-793166f699ce 51393-7334 HUMAN OTC DRUG Wart Control Extra Strength CALENDULA OFFICINALIS FLOWERING TOP, Causticum, PHYTOLACCA AMERICANA ROOT, THUJA OCCIDENTALIS LEAFY TWIG, and SODIUM CHLORIDE SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; PHYTOLACCA AMERICANA ROOT; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 8; 8; 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-7335_3c8202a6-4806-47de-92cd-4b597a83d493 51393-7335 HUMAN OTC DRUG Wart Control Super Strength CALENDULA OFFICINALIS FLOWERING TOP, CAUSTICUM, PHYTOLACCA AMERICANA ROOT, THUJA OCCIDENTALIS LEAFY TWIG, SODIUM CHLORIDE, and SALICYLIC ACID SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; PHYTOLACCA AMERICANA ROOT; SALICYLIC ACID; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-7336_549b4b9c-fc9e-4ddf-8a2f-4fcdad569ed2 51393-7336 HUMAN OTC DRUG Wart Control Extreme CALENDULA OFFICINALIS FLOWERING TOP, Causticum, Phytolacca Americana Root, Thuja occidentalis leafy twig, SODIUM CHLORIDE, and Salicylic Acid SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; PHYTOLACCA AMERICANA ROOT; SALICYLIC ACID; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12; 12; 12 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-7433_64f81768-7895-4130-bb10-325f06d1885c 51393-7433 HUMAN OTC DRUG Wart Control CALENDULA OFFICINALIS FLOWERING TOP, THUJA OCCIDENTALIS LEAFY TWIG, and PHYTOLACCA AMERICANA ROOT SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6 [hp_M]/1000mL; [hp_M]/1000mL; [hp_M]/1000mL 51393-7434_e467280a-6b78-43a9-934a-44a5a54409b6 51393-7434 HUMAN OTC DRUG Wart Control Extra Strength CALENDULA OFFICINALIS FLOWERING TOP, PHYTOLACCA AMERICANA ROOT, and THUJA OCCIDENTALIS LEAFY TWIG SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-7436_04554d3c-145a-4832-9eed-a40a18e98b92 51393-7436 HUMAN OTC DRUG Wart Control Extreme CALENDULA OFFICINALIS FLOWERING TOP, PHYTOLACCA AMERICANA ROOT, and THUJA OCCIDENTALIS LEAFY TWIG SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-7522_dc6563c3-3f18-4d5a-bf44-02304df92733 51393-7522 HUMAN OTC DRUG Rheumatoid Arthritis Pain Management Horse Chestnut, Caulophyllum Thalictroides Root, Phytolacca Americana Root, Ruta Graveolens Flowering Top, and Silicon Dioxide SOLUTION/ DROPS TOPICAL 20130101 UNAPPROVED HOMEOPATHIC Forces of Nature CAULOPHYLLUM THALICTROIDES ROOT; HORSE CHESTNUT; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE 3; 12; 12; 30; 12 [hp_X]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_X]/100mL 51393-7533_f961c452-78b0-40ee-b69d-f56ee92cc1f9 51393-7533 HUMAN OTC DRUG Sleep Well Being Control Avena Sativa Flowering Top, Arabica Coffee Bean, Lavandula Angustifolia Flowering Top, Passiflora Incarnata Flowering Top, Piper Methysticum Root, and Valerian SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; LAVANDULA ANGUSTIFOLIA FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; PIPER METHYSTICUM ROOT; VALERIAN 30; 30; 12; 30; 30; 12 [hp_C]/100mL; [hp_X]/1000mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL 51393-7544_374c6a4b-4ed6-4da8-bddf-8236661b8206 51393-7544 HUMAN OTC DRUG Insomnia Control Arabica Coffee Bean, Lactuca Virosa, Lavandula Angustifolia Flowering Top, HOPS, Piper Methysticum Root, Verbena Hastata Root, and Scutellaria Lateriflora SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature ARABICA COFFEE BEAN; HOPS; LACTUCA VIROSA; LAVANDULA ANGUSTIFOLIA FLOWERING TOP; PIPER METHYSTICUM ROOT; SCUTELLARIA LATERIFLORA; VERBENA HASTATA ROOT 30; 30; 12; 12; 30; 12; 6 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL 51393-7566_02ca5d8a-66d6-4fff-94f8-69e0099d8508 51393-7566 HUMAN OTC DRUG Nerve Pain Arabica Coffee Bean, Silicon Dioxide, and Hypericum Perforatum SOLUTION/ DROPS TOPICAL 20130101 UNAPPROVED HOMEOPATHIC Forces of Nature ARABICA COFFEE BEAN; HYPERICUM PERFORATUM; SILICON DIOXIDE 30; 30; 30 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL 51393-7577_30a786fd-3d2d-4839-9067-641aefa8421d 51393-7577 HUMAN OTC DRUG Headache Pain Management Iris Versicolor Root, Lavandula Angustifolia Flowering Top, and Silicon Dioxide SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature IRIS VERSICOLOR ROOT; LAVANDULA ANGUSTIFOLIA FLOWERING TOP; SILICON DIOXIDE 30; 12; 30 [hp_C]/100mL; [hp_X]/1000mL; [hp_C]/100mL 51393-7588_1e4f62af-3249-4f28-8c60-818ffc27641c 51393-7588 HUMAN OTC DRUG Migraine Pain Management Iris Versicolor Root and Sodium Chloride SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature IRIS VERSICOLOR ROOT; SODIUM CHLORIDE 12; 30 [hp_X]/1000mL; [hp_C]/100mL 51393-7590_22a4b29d-a4df-4426-a3ce-ddb4c797aa2a 51393-7590 HUMAN OTC DRUG Osteoarthritis Pain management Horse Chestnut and Ruta Graveolens Flowering Top SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature HORSE CHESTNUT; RUTA GRAVEOLENS FLOWERING TOP 30; 30 [hp_C]/1000mL; [hp_C]/100mL 51393-7599_d03c9804-011e-4eb7-9c6e-1038881c7894 51393-7599 HUMAN OTC DRUG Ringworm Control Thuja Occidentalis Leaf, Silicon Dioxide, and Sodium Chloride SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature SILICON DIOXIDE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAF 10; 10; 10 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-7611_a209e729-35ef-4e1b-a670-30262fa95ca8 51393-7611 HUMAN OTC DRUG Athletes Foot/Jock Itch Control Centella Asiatica, Silicon Dioxide, and Thuja Occidentalis Root SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature CENTELLA ASIATICA; SILICON DIOXIDE; THUJA OCCIDENTALIS ROOT 30; 8; 30 [hp_C]/100mL; [hp_X]/1000mL; [hp_C]/100mL 51393-7633_1141e3e2-ad9c-44c2-81f6-6ed09220e1e8 51393-7633 HUMAN OTC DRUG Psoriasis Control Centella Asiatica, Sodium Chloride, and Silicon Dioxide SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature CENTELLA ASIATICA; SILICON DIOXIDE; SODIUM CHLORIDE 12; 8; 30 [hp_C]/100mL; [hp_X]/1000mL; [hp_X]/1000mL 51393-7655_79027444-53c9-4c61-96f1-c2a38e521565 51393-7655 HUMAN OTC DRUG Gout Control Arnica Montana, Urtica Urens, Silicon Dioxide, and Thuja Occidentalis Root SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature ARNICA MONTANA; SILICON DIOXIDE; THUJA OCCIDENTALIS ROOT; URTICA URENS 30; 8; 12; 30 [hp_C]/100mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_C]/100mL 51400-001_02f43acd-95a8-42ba-bd12-cdfea66a36aa 51400-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19760101 UNAPPROVED MEDICAL GAS Mid South Welding Supply, Inc OXYGEN 99 L/100L 51401-002_c536b73e-65b8-4dae-9e44-32124e551aab 51401-002 HUMAN OTC DRUG SKIN STRONG - SKIN EQUIPMENT SPF 55 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20120830 OTC MONOGRAPH FINAL part352 True Balance Athletics LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 51401-030_e3470bcf-caa8-443f-91d5-329acba12c76 51401-030 HUMAN OTC DRUG SKIN STRONG - SKIN EQUIPMENT SPF 30 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120830 OTC MONOGRAPH FINAL part352 True Balance Athletics LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 75; 50; 27.5; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 51414-100_6774110b-d7bc-4504-a716-4a37935cde1e 51414-100 HUMAN OTC DRUG HAND SANITIZER ALCOHOL GEL TOPICAL 20100629 OTC MONOGRAPH FINAL part348 Yuyao Jessie Promotional Products Co., Ltd. ALCOHOL 62 mL/100mL 51414-101_9d93d5d3-2ba7-4860-9a9b-beccbc249bd2 51414-101 HUMAN OTC DRUG aloe vera gel ALOE VERA LEAF GEL TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part356 Yuyao Jessie Commodity Co.,Ltd. ALOE VERA LEAF 5 g/100g 51414-200_ead90432-b6f9-457d-a022-b0c76a2e9d24 51414-200 HUMAN OTC DRUG Sun Block octyl methoxycinnamate BENZOPHENONE-3 TITANIUM DIOXIDE Homosalate CREAM TOPICAL 20100630 OTC MONOGRAPH FINAL part352 Yuyao Jessie Promotional Products Co., Ltd. HOMOSALATE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 6; 8; 7.5; 8 mL/100mL; mL/100mL; mL/100mL; mL/100mL 51414-300_9243ba6b-176b-49cf-85b1-a2ef6cbd7114 51414-300 HUMAN OTC DRUG LIP BALM Avobenzone Octinoxate OINTMENT TOPICAL 20100919 OTC MONOGRAPH FINAL part352 Yuyao Jessie Promotional Products Co., Ltd. AVOBENZONE; OCTINOXATE 1.5; 6 g/100g; g/100g 51414-400_c2d4ce7c-06eb-4f52-b046-6505165e71ef 51414-400 HUMAN OTC DRUG antibacterial wet wipes Benzalkonium Chloride SWAB TOPICAL 20120508 OTC MONOGRAPH NOT FINAL part333A Yuyao Jessie Commodity Co.,Ltd. BENZALKONIUM CHLORIDE .13 g/100g 51414-500_b4b2224e-107c-4ede-9f59-944acd52e97f 51414-500 HUMAN OTC DRUG mouth fresh Cetylpyridinium Chloride SPRAY TOPICAL 20120912 OTC MONOGRAPH NOT FINAL part356 Yuyao Jessie Commodity Co.,Ltd. CETYLPYRIDINIUM CHLORIDE .05 mL/100mL 51414-600_2c7c503c-c846-4e56-b23b-0481a8b57002 51414-600 HUMAN OTC DRUG SPF15 sunscreen Octinoxate,oxybenzone,OCTISALATE SPRAY TOPICAL 20120912 OTC MONOGRAPH NOT FINAL part352 Yuyao Jessie Commodity Co.,Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE 4; 2; 4 g/100g; g/100g; g/100g 51414-700_74b389c8-d00d-4db4-af51-d8ecd69f9134 51414-700 HUMAN OTC DRUG LENS CLEANER isopropyl alcohol SPRAY TOPICAL 20121128 OTC MONOGRAPH FINAL part344 Yuyao Jessie Commodity Co.,Ltd. ISOPROPYL ALCOHOL 15 g/100g 51414-800_751e5d47-5817-4828-a5bc-6bd1f3213946 51414-800 HUMAN OTC DRUG antibacterial hand sanitizer Benzalkonium Chloride GEL TOPICAL 20140227 OTC MONOGRAPH NOT FINAL part333E Yuyao Jessie Commodity Co.,Ltd. BENZALKONIUM CHLORIDE .25 g/100g 51414-900_4bdf44a4-e969-4533-870e-e98ca64bc97b 51414-900 HUMAN OTC DRUG SUNSCREEN STICK Octinoxate,ZINC OXIDE,OCTISALATE SPRAY TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part352 Yuyao Jessie Commodity Co.,Ltd. OCTINOXATE; OCTISALATE; ZINC OXIDE 3; 3; 1 g/100g; g/100g; g/100g 51417-0001_b11f5de7-9a91-4b52-a0c8-06c47e8ce133 51417-0001 HUMAN OTC DRUG REN Satin Perfection BB Sunscreen Broad Spectrum SPF 15 Light-Medium ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20121026 OTC MONOGRAPH FINAL part352 Ren Ltd. TITANIUM DIOXIDE; ZINC OXIDE 28; 57 mg/mL; mg/mL 51417-3340_81103f19-72d2-44e3-8988-fe4a9a00ebe2 51417-3340 HUMAN OTC DRUG ClearCalm 3 Acne Treatment Mask SULFUR CREAM TOPICAL 20100530 OTC MONOGRAPH FINAL part333D Ren Ltd. SULFUR 5 g/100g 51417-3341_37b93957-93f9-4ae6-9c89-24ff748ceb56 51417-3341 HUMAN OTC DRUG ClearCalm 3 Anti-Acne Starter SULFUR CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part333D Ren Ltd. SULFUR 5 g/100g 51435-001_17f26cc3-8018-40e5-a80a-f33323219020 51435-001 HUMAN OTC DRUG NEUTRACETT ULCER ALLANTOIN GLYCERIN GEL TOPICAL 20100528 OTC MONOGRAPH FINAL part347 ADVANCED BIOMEDICS INC ALLANTOIN; GLYCERIN .5; 50 mg/.1g; mg/g 51435-002_cdf18699-0fa4-416f-ba57-a4519713ee71 51435-002 HUMAN OTC DRUG NEUTRACETT TATTOO ALLANTOIN GLYCERIN GEL TOPICAL 20100528 OTC MONOGRAPH FINAL part347 ADVANCED BIOMEDICS INC ALLANTOIN; GLYCERIN .5; 50 mg/.1g; mg/g 51435-003_81cba866-6c48-4bcc-9a4b-71639db28533 51435-003 HUMAN OTC DRUG NEUTRACETT ALL PURPOSE ALLANTOIN GLYCERIN GEL TOPICAL 20100528 OTC MONOGRAPH FINAL part347 ADVANCED BIOMEDICS INC ALLANTOIN; GLYCERIN .5; 50 mg/.1g; mg/g 51439-001_d12e00d9-1373-4c8e-accc-8c24c2dbd14d 51439-001 HUMAN OTC DRUG Simply Firm Eye - Non-Surgical Face Lift dimethicone gel GEL TOPICAL 20120627 OTC MONOGRAPH FINAL part347 CarePluss Pharma S.A. de C.V. DIMETHICONE .6 mg/60mg 51439-002_f1525fc3-925b-44f9-a654-ef41076af283 51439-002 HUMAN OTC DRUG Simply Firm - Face and Neck Non Surgical Face Lift Dimethicone GEL TOPICAL 20120627 OTC MONOGRAPH FINAL part347 CarePluss Pharma S.A. de C.V. DIMETHICONE .00119 mg/.119mg 51439-003_1ad3a24f-b2cb-4189-aa4c-b4670bc8d657 51439-003 HUMAN OTC DRUG Simply Firm - Body Gelcreme Dimethicone GEL TOPICAL 20120805 OTC MONOGRAPH FINAL part347 CarePluss Pharma S.A. de C.V. DIMETHICONE .0024 mg/.024mg 51439-004_f8f84d20-59c6-4bc7-a048-71a35b22377c 51439-004 HUMAN OTC DRUG Treatment 101 Acne Clearing Treatment Sulphur LIQUID TOPICAL 20120806 OTC MONOGRAPH FINAL part333D CarePluss Pharma S.A. de C.V. SULFUR .003 mg/.06mg 51439-005_49d3fb03-dee3-45de-b2ec-caf1443bafd2 51439-005 HUMAN OTC DRUG Cleanser Acne Clearing Treatment Benzoyl Peroxide LIQUID TOPICAL 20120806 OTC MONOGRAPH FINAL part333D CarePluss Pharma S.A. de C.V. BENZOYL PEROXIDE .006 mg/.024mg 51439-006_9b4b6abd-2b57-42a9-9d48-4c625358ebd5 51439-006 HUMAN OTC DRUG Tonic Acne Clearing Treatment Salicylic Acid LIQUID TOPICAL 20120806 OTC MONOGRAPH FINAL part333D CarePluss Pharma S.A. de C.V. SALICYLIC ACID .0024 mg/.12mg 51439-007_d08e6fbf-9162-47cd-9cf6-74ea24d48214 51439-007 HUMAN OTC DRUG Acne Clearning Treatment Face SULFUR, BENZOYL PEROXIDE, SALICYLIC ACID LIQUID TOPICAL 20120806 OTC MONOGRAPH FINAL part333D CarePluss Pharma S.A. de C.V. BENZOYL PEROXIDE; SALICYLIC ACID; SULFUR .006; .0048; .012 mg/.024mg; mg/.024mg; mg/.024mg 51441-003_60276871-18b7-41a9-a041-adc91dcc5449 51441-003 HUMAN OTC DRUG Every Day COCONUT Daily Face Broad Spectrum SPF 15 ZINC OXIDE LOTION TOPICAL 20130424 OTC MONOGRAPH NOT FINAL part352 Agbanga Karite LLC, / EveryDay Shea / Alaffia Sustainable Skin Care ZINC OXIDE 100 mg/mL 51442-327_3ef80ca8-79fd-4e32-9319-f48ecbe3e8d3 51442-327 HUMAN OTC DRUG Colgate Junior Bubblefruit Sodium Fluoride GEL, DENTIFRICE DENTAL 20110725 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g 51442-330_a0d37acc-6da3-4237-8248-090e49f64230 51442-330 HUMAN OTC DRUG Colgate Toothpaste Great Regular Flavor Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20090604 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 51442-531_3c19876c-8ddb-417f-81e0-7cc3057dfea9 51442-531 HUMAN OTC DRUG Colgate SpongeBob SquarePants Sodium Fluoride GEL, DENTIFRICE DENTAL 20110316 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g 51442-531_68aa936b-7ecc-4ced-8b48-87aaad9c4b5e 51442-531 HUMAN OTC DRUG Colgate SpongeBob SquarePants Sodium Fluoride GEL, DENTIFRICE DENTAL 20110718 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g 51442-534_934fee9c-1485-4811-8f88-636fc45af1e6 51442-534 HUMAN OTC DRUG Colgate Dora the Explorer Mild Bubblefruit Flavor Sodium Fluoride GEL, DENTIFRICE DENTAL 20110316 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g 51442-536_8738dd29-a28f-4e85-9a4f-0ea22bfc89fa 51442-536 HUMAN OTC DRUG Colgate Triple Action Original Mint Fluoride Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100407 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g 51442-536_b549e058-9e54-45a7-818a-3975353e160d 51442-536 HUMAN OTC DRUG Colgate Triple Action Original Mint Fluoride Sodium Fluoride PASTE, DENTIFRICE DENTAL 20101117 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g 51442-536_dbc41b46-e88d-4d6e-b4a1-f9367f6e5891 51442-536 HUMAN OTC DRUG Colgate Triple Action Original Mint Fluoride Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100407 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g 51442-537_67f4a31b-e66a-4478-994d-c49ab6707674 51442-537 HUMAN OTC DRUG Colgate Bakugan Fluoride Mild Bubblefruit Flavor Sodium Fluoride GEL, DENTIFRICE DENTAL 20091118 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g 51442-542_d66848fb-1f17-4389-b9c1-8d8684867b30 51442-542 HUMAN OTC DRUG Colgate Proclinical Refreshing Mint Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20091208 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM MONOFLUOROPHOSPHATE 11.4 mg/g 51442-543_436f783f-f72e-45fe-8ce5-e652c3cfb3ab 51442-543 HUMAN OTC DRUG COLGATE PROCLINICAL - Sparkling Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20101110 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g 51442-543_54178021-35d1-452f-91ae-79ac7ceaa606 51442-543 HUMAN OTC DRUG COLGATE PROCLINICAL - Sparkling Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100409 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g 51442-543_f5db5787-7189-4b7c-80d1-c80f83534a5a 51442-543 HUMAN OTC DRUG COLGATE PROCLINICAL - SPARKLING MINT SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20101110 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g 51442-544_2b40d7b2-a6d9-477f-8cd1-08abc6af9bb6 51442-544 HUMAN OTC DRUG Colgate Proclinical - Clean Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100125 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g 51442-545_3f0b2c46-69df-4417-9b76-9d28a93c161c 51442-545 HUMAN OTC DRUG Colgate Junior - Pink Sparkle Sodium Fluoride GEL, DENTIFRICE DENTAL 20110725 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g 51442-546_b378707e-c67c-40ed-b92e-158d21c5fc35 51442-546 HUMAN OTC DRUG Colgate Fluoride Whitening - Reviving Mint Sodium Fluoride GEL, DENTIFRICE DENTAL 20101110 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g 51442-546_d5e8f32d-d289-4cbf-80c9-81986498e268 51442-546 HUMAN OTC DRUG COLGATE FLUORIDE WHITENING - REVIVING MINT SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20101110 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g 51442-547_0ee4332a-c6c4-4e9c-a586-1d7c96b780ae 51442-547 HUMAN OTC DRUG Colgate Transformers Mild Bubblefruit Flavor Sodium Fluoride GEL, DENTIFRICE DENTAL 20110316 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g 51442-552_a3a8dc1f-df48-4783-a770-297d31d2b131 51442-552 HUMAN OTC DRUG Colgate Optic White - Sparkling Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110606 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 51442-552_b6565f25-7482-4572-a954-991ab1b133fd 51442-552 HUMAN OTC DRUG Colgate Optic White - Sparkling Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110606 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 51442-552_decc5ca8-9818-48d1-ad7d-48662fd769c8 51442-552 HUMAN OTC DRUG Colgate Optic White - Sparkling Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110606 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 51444-001_e9885138-6619-4675-83a7-eedadeeca8a8 51444-001 HUMAN OTC DRUG Cold Rub Camphor Eucalyptus Oil Menthol OINTMENT TOPICAL 20100615 OTC MONOGRAPH FINAL part341 JMD All Star Impex Inc. CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.8 g/100g; g/100g; g/100g 51444-002_95252cf9-2357-4cc7-b63f-f1c7cca6b99d 51444-002 HUMAN OTC DRUG Blue Ice Menthol GEL TOPICAL 20100615 OTC MONOGRAPH NOT FINAL part348 JMD All Star Impex Inc MENTHOL 2 g/100g 51444-003_6d9184c3-c7ba-453c-bd39-33fe6a8207f5 51444-003 HUMAN OTC DRUG Divas Isopropyl Alcohol LIQUID TOPICAL 20100726 OTC MONOGRAPH NOT FINAL part333 JMD All Star Impex Inc ISOPROPYL ALCOHOL 50 mL/100mL 51444-004_3e525fe4-9f5e-43d6-aef2-6bc5d4421bda 51444-004 HUMAN OTC DRUG Divas Hydrogen Peroxide LIQUID TOPICAL 20100726 OTC MONOGRAPH NOT FINAL part333 JMD All Star Impex Inc HYDROGEN PEROXIDE 3 mL/100mL 51444-005_b4d7cdbf-0a8a-4b1d-b7b5-3ce39d6b5fcf 51444-005 HUMAN OTC DRUG Divas Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20100726 OTC MONOGRAPH NOT FINAL part333 JMD All Star Impex Inc ISOPROPYL ALCOHOL 50 mL/100mL 51445-101_877fc49a-0836-4eba-85bb-c8d4241823c9 51445-101 HUMAN OTC DRUG THERABIOGEN COLD AND FLU RELIEF NASAL CAMELIA SINENSIS, SAMBUCUS NIGRA, GELSEMIUM SEMPERVIRENS, BRYONIA ALBA, SULPHUR SPRAY NASAL 20100929 UNAPPROVED HOMEOPATHIC THERABIOGEN BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; GREEN TEA LEAF; SAMBUCUS NIGRA FLOWERING TOP; SULFUR 6; 6; 3; 2; 12 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL 51445-201_450d394b-f4ce-4139-9aa5-c6b6d27caef2 51445-201 HUMAN OTC DRUG THERAMAX ALLERGY RELIEF NASAL CAMELLIA SINENSIS, ALLIUM CEPA, NATRUM MURIATICUM, NUX VOMICA, LUFFA OPERCULATA, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORUM, SULPHUR SPRAY NASAL 20100929 UNAPPROVED HOMEOPATHIC THERABIOGEN GALPHIMIA GLAUCA FLOWERING TOP; GREEN TEA LEAF; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; ONION; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 3; 12; 6; 6; 6; 6; 12 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL 51447-1256_2e458147-1354-437f-9d62-39ddb2bed7ff 51447-1256 HUMAN OTC DRUG BZK benzalkonium chloride LIQUID TOPICAL 20140716 OTC MONOGRAPH NOT FINAL part333E BIC Graphic USA Manufacturing Co, Inc. BENZALKONIUM CHLORIDE .0013 g/g 51452-001_2c011b95-a625-49a4-9e9f-d5d8bc58fccc 51452-001 HUMAN OTC DRUG Cold Spot Point Relief menthol, methyl salicylate GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Fabrication Enterprises MENTHOL; METHYL SALICYLATE 14; 5 mL/120mL; mL/120mL 51452-001_2c55ca7c-9d77-4c53-8550-d8adb8652671 51452-001 HUMAN OTC DRUG Cold Spot Point Relief menthol, methyl salicylate GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Fabrication Enterprises MENTHOL; METHYL SALICYLATE .46; .15 L/3.8L; L/3.8L 51452-001_501e3f34-2a0d-4b46-8dbe-fb38fe21725e 51452-001 HUMAN OTC DRUG Cold Spot Point Relief menthol, methyl salicylate GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Fabrication Enterprises MENTHOL; METHYL SALICYLATE .6; .2 g/5g; g/5g 51452-001_8bdc5379-f2d4-4c2b-affa-8fdd375c7713 51452-001 HUMAN OTC DRUG Cold Spot Point Relief menthol, methyl salicylate GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Fabrication Enterprises MENTHOL; METHYL SALICYLATE 58; 19 mL/480mL; mL/480mL 51452-001_ead9ecab-eb28-4ab7-aa51-2665515dbe26 51452-001 HUMAN OTC DRUG Cold Spot Point Relief menthol, methyl salicylate GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Fabrication Enterprises MENTHOL; METHYL SALICYLATE 115; 38 mL/960mL; mL/960mL 51452-002_f3dbe088-aa4c-4a3f-a47d-0cddf8d6eb0b 51452-002 HUMAN OTC DRUG Cold Spot Point Relief menthol OINTMENT TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Fabrication Enterprises MENTHOL 13 mL/90mL 51452-003_292ef35f-2957-472e-ba68-6cf9e2ea51a2 51452-003 HUMAN OTC DRUG Cold Spot Point Relief menthol AEROSOL, SPRAY TOPICAL 20100824 OTC MONOGRAPH FINAL part341 fabrication enterprises MENTHOL 12 mL/120mL 51452-003_37881d6e-e632-49ce-9d01-c3e7a3bd4c62 51452-003 HUMAN OTC DRUG Cold Spot Point Relief menthol AEROSOL, SPRAY TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Fabrication Enterprises MENTHOL 6 mL/60mL 51452-003_fbe6ecf2-e153-4ebb-a3bc-7d259cc9528d 51452-003 HUMAN OTC DRUG Cold Spot Point Relief menthol AEROSOL, SPRAY TOPICAL 20100824 OTC MONOGRAPH FINAL part341 fabrication enterprises MENTHOL 48 mL/480mL 51452-004_2409526b-8656-40bd-aacc-92ed34dbae76 51452-004 HUMAN OTC DRUG Cold Spot Point Relief MENTHOL SWAB TOPICAL 20111013 OTC MONOGRAPH FINAL part341 Fabrication Enterprises, inc. MENTHOL .96 mL/8mL 51452-005_5a2a8dbf-7614-4b9c-a662-65a472413df0 51452-005 HUMAN OTC DRUG Cold Spot Point Relief MENTHOL GEL TOPICAL 20111013 OTC MONOGRAPH FINAL part341 Fabrication Enterprises, inc. MENTHOL; METHYL SALICYLATE 14.4; 4.8 mL/120mL; mL/120mL 51452-010_6bc5eb25-fdf2-46e9-b082-e5f513fe4a4c 51452-010 HUMAN OTC DRUG Hot Spot Point Relief capsaicin GEL TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part348 fabrication enterprises CAPSAICIN .5 mL/90mL 51452-010_8ce3d37a-9895-4d32-8185-7f24a5be1ad6 51452-010 HUMAN OTC DRUG Hot spot point relief CAPSAICIN GEL TOPICAL 20111013 OTC MONOGRAPH FINAL part348 Fabrication Enterprises, inc. CAPSAICIN .03 mL/5mL 51452-010_b6ff1f9c-dc08-4fd5-ad19-08b0bef51f65 51452-010 HUMAN OTC DRUG Hot Spot Point Relief capsaicin GEL TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part348 fabrication enterprises CAPSAICIN 5.8 mL/960mL 51452-010_ca3651ed-2554-4696-a744-5e19f604d75f 51452-010 HUMAN OTC DRUG Hot Spot Point Relief capsaicin GEL TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part348 fabrication enterprises CAPSAICIN 1.5 mL/240mL 51456-272_b34b6481-73fd-40af-b7d8-c9b66d984375 51456-272 HUMAN OTC DRUG Benefect Natural Hand Sanitizer Thymol SPRAY TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part347 Sensible Life Products THYMOL .06 mL/120mL 51456-299_b34b6481-73fd-40af-b7d8-c9b66d984375 51456-299 HUMAN OTC DRUG Benefect Natural Hand Sanitizer Thymol LIQUID TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part347 Sensible Life Products THYMOL .5 mL/L 51457-000_f84e5afb-4989-474c-8ed7-0a5229d17621 51457-000 HUMAN OTC DRUG Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20120607 OTC MONOGRAPH FINAL part348 Theraplex Solutions HISTAMINE DIHYDROCHLORIDE; MENTHOL .1; 3 g/100g; g/100g 51457-001_135c7403-c431-4578-982a-a73925eb5ab9 51457-001 HUMAN OTC DRUG ALO THERAPEUTIC MASSAGE PAIN RELIEVING MENTHOL, HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20130320 OTC MONOGRAPH FINAL part348 Theraplex Solutions HISTAMINE DIHYDROCHLORIDE; MENTHOL .1; 3 g/100g; g/100g 51460-0275_2730d4f5-7ec5-4caf-be4a-b9ca774a35cb 51460-0275 HUMAN OTC DRUG AMERFRESH ANTIBACTERIAL DEODORANT TRICLOCARBAN SOAP TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E Amercare Products, Inc. TRICLOCARBAN 1.5 g/100g 51460-0502_843e8d6b-8bb6-4c81-8089-8a500ebe6bd4 51460-0502 HUMAN OTC DRUG Amerfresh Sodium Monofluorophosphate POWDER DENTAL 19960101 OTC MONOGRAPH FINAL part355 Amercare Products Inc SODIUM MONOFLUOROPHOSPHATE .76 g/100g 51460-0504_01111ea5-3692-4b9a-889f-6619fb056913 51460-0504 HUMAN OTC DRUG Amerfresh Medicated Menthol and Zinc Oxide POWDER TOPICAL 20050101 OTC MONOGRAPH FINAL part347 Amercare Products Inc MENTHOL; ZINC OXIDE .15; 1 g/100g; g/100g 51460-1111_f4796a85-7502-4122-92d5-4c8af32d3273 51460-1111 HUMAN OTC DRUG AmerFresh Sodium Fluoride GEL, DENTIFRICE ORAL 20121114 OTC MONOGRAPH FINAL part355 Amercare Products, Inc. SODIUM FLUORIDE .187 g/85g 51460-1112_bcfcec5f-dd34-4846-a15e-a2e639956c1a 51460-1112 HUMAN OTC DRUG AmerFresh Sodium Monofluorophosphate PASTE, DENTIFRICE ORAL 20121114 OTC MONOGRAPH FINAL part355 Amercare Products, Inc. SODIUM MONOFLUOROPHOSPHATE 1 mg/g 51460-1113_c4e05d34-45f9-4883-9238-628b1562a55b 51460-1113 HUMAN OTC DRUG AmerFresh Sodium Monofluorophosphate POWDER, DENTIFRICE ORAL 20111220 OTC MONOGRAPH FINAL part355 Amercare Products, Inc. SODIUM MONOFLUOROPHOSPHATE .4332 g/57g 51460-4943_c7638a29-e685-4160-a04b-fc797af08702 51460-4943 HUMAN OTC DRUG AMERFRESH ANTIPERSPIRANT DEODORANT ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20100706 OTC MONOGRAPH FINAL part350 Amercare Products, Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 51460-4967_9c8aa994-6715-471d-9fc7-b88d21eec369 51460-4967 HUMAN OTC DRUG AMERFRESH ANTIPERSPIRANT DEODORANT ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20100706 OTC MONOGRAPH FINAL part350 Amercare Products, Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 51460-4974_693175b7-e3b0-4ff1-ad0e-3e5368205ace 51460-4974 HUMAN OTC DRUG AMERFRESH ROLL-ON ANTIPERSPIRANT DEODORANT ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100706 OTC MONOGRAPH FINAL part350 Amercare Products, Inc ALUMINUM CHLOROHYDRATE 1 mL/100mL 51460-5000_ce8b2eb8-b3cb-4c19-9308-0a5cb68fa0d2 51460-5000 HUMAN OTC DRUG Amerfresh Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 19960101 OTC MONOGRAPH FINAL part355 Amercare Products Inc SODIUM MONOFLUOROPHOSPHATE .76 g/100g 51460-5010_27b8a829-d438-439c-b6f5-710cb8e2de7a 51460-5010 HUMAN OTC DRUG Amerfresh Clear Sodium Fluoride PASTE, DENTIFRICE DENTAL 19960101 OTC MONOGRAPH FINAL part355 Amercare Products Inc SODIUM FLUORIDE .22 g/100g 51467-005_efd1121d-f24a-4d88-8576-03ce2edffd96 51467-005 HUMAN OTC DRUG COLTALIN Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride TABLET ORAL 20040301 OTC MONOGRAPH FINAL part341 FORTUNE PHARMACAL COMPANY LIMITED ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 51467-006_fa8ca38c-41d8-475d-8d52-cef0fa36635a 51467-006 HUMAN OTC DRUG CHILDRENS COLTALIN ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE TABLET, CHEWABLE ORAL 20040301 OTC MONOGRAPH FINAL part341 FORTUNE PHARMACAL COMPANY LIMITED ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 80; .5; 1.25 mg/1; mg/1; mg/1 51467-007_732d3321-9c49-429b-86b9-7f3f6f950eff 51467-007 HUMAN OTC DRUG COLTALIN-DM ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20040301 OTC MONOGRAPH FINAL part341 FORTUNE PHARMACAL COMPANY LIMITED ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 51467-008_e977fe6b-4e9e-4eae-9cbc-bf56cfb9231c 51467-008 HUMAN OTC DRUG COLTALIN-ND ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20040301 OTC MONOGRAPH FINAL part341 FORTUNE PHARMACAL COMPANY LIMITED ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 51467-127_b5f2af89-8122-4675-af32-0223b66865c0 51467-127 HUMAN OTC DRUG FORTOLIN ACETAMINOPHEN TABLET ORAL 20040301 OTC MONOGRAPH NOT FINAL part343 FORTUNE PHARMACAL COMPANY, LIMITED ACETAMINOPHEN 500 mg/1 51477-001_0dda86e7-da48-49ba-8fdb-102d546d35e6 51477-001 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20101025 NDA AUTHORIZED GENERIC NDA018238 Nesher Pharmaceuticals (USA) LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 51477-002_0dda86e7-da48-49ba-8fdb-102d546d35e6 51477-002 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20101025 NDA AUTHORIZED GENERIC NDA018238 Nesher Pharmaceuticals (USA) LLC POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 51483-002_6e3069bd-e7ef-4f98-a0c7-18b7ce943776 51483-002 HUMAN OTC DRUG Burn-B Gone OTC Allantoin GEL TOPICAL 20100601 OTC MONOGRAPH FINAL part347 DeWitt Laboratories, Inc ALLANTOIN .75 g/75g 51486-002_7a8d5a02-c39b-4834-9beb-d8b5596681b0 51486-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20100101 UNAPPROVED MEDICAL GAS ILMO Products Company NITROGEN 990 mL/L 51486-003_267259c1-4acc-4248-82c3-ee0ff0da4b3f 51486-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19950101 UNAPPROVED MEDICAL GAS ILMO Products Company NITROUS OXIDE 990 mL/L 51486-004_76d7bfb2-ea92-491c-bbcb-e4ebfaa44775 51486-004 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20090101 UNAPPROVED MEDICAL GAS ILMO Products Company AIR 1000 mL/L 51486-720_f0119378-6a97-4d28-8f29-cc6243aeadba 51486-720 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS ILMO Products Company OXYGEN 990 mL/L 51500-001_d8c3bcfe-7802-4c9a-a1dc-bc53410cf60b 51500-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140101 NDA NDA205849 Corsicana Welding Supply, Inc. OXYGEN 990 mL/L 51511-514_0ce3d56c-6195-4eee-bb7c-d3a9392c96b6 51511-514 HUMAN OTC DRUG Salicylic Acid Corn Remover Salicylic Acid STRIP TOPICAL 20100201 OTC MONOGRAPH FINAL part358B ASO Pharmaceutical Co. Ltd. SALICYLIC ACID 40 mg/1 51511-596_4edae879-d026-4c2d-b14b-9a82c12a6352 51511-596 HUMAN OTC DRUG Salicylic Acid Wart Remover Salicylic Acid STRIP TOPICAL 20090201 OTC MONOGRAPH FINAL part358H ASO Pharmaceutical Co. Ltd. SALICYLIC ACID 40 mg/1 51514-0205_5865f784-16c1-46b0-8b1a-7c58d95adaab 51514-0205 HUMAN OTC DRUG GAP Favorite Lip Balm Juicy Pear SPF 18 Octinoxate and Oxybenzone STICK TOPICAL 20111116 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g 51514-0212_fb302cea-25fd-4bc0-95e5-44a331dc7cd4 51514-0212 HUMAN OTC DRUG GAP Favorite Lip Balm Citrus Splash SPF 18 Octinoxate and Oxybenzone STICK TOPICAL 20111116 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g 51514-0213_7a16cb98-bd5b-4440-b3a7-d358ee39adeb 51514-0213 HUMAN OTC DRUG Gap favorite Lip Balm Strawberry Kiwi Octinoxate and Oxybenzone STICK TOPICAL 20111117 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g 51514-0214_fc3ac297-caf8-4d57-baab-b6a63b60ca25 51514-0214 HUMAN OTC DRUG GAP Favorite Lip Balm Creamy Pomegranate SPF 18 Octinoxate and Oxybenzone STICK TOPICAL 20111121 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g 51514-0215_c679096d-25ca-4381-aed0-111701137af7 51514-0215 HUMAN OTC DRUG Gap Favorite Lip Balm Vanilla Mint SPF Octinoxate and Oxybenzone STICK TOPICAL 20111117 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc. OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g 51514-0217_ec87de8a-37d4-4074-8538-e721380ee5b4 51514-0217 HUMAN PRESCRIPTION DRUG GAP Favorite Lip Balm Berry Punch SPF 18 Octinoxate and Oxybezone STICK TOPICAL 20111121 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g 51514-0218_b8815d31-bc15-4afd-8f86-3f8564eda7d0 51514-0218 HUMAN OTC DRUG GAP Favorite Lip Balm Pomegranate SPF 18 Octinoxate and Oxybenzone STICK TOPICAL 20111116 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g 51514-0219_10173658-2081-4683-a717-7ff8219136fe 51514-0219 HUMAN OTC DRUG GAP Favorite Lip Balm Tropical Twist SPF 18 Octinoxate and Oxybenzone STICK TOPICAL 20111121 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g 51514-0220_ee4cf10e-c704-4ab0-a724-78979568dd79 51514-0220 HUMAN OTC DRUG GAP Favorite Lip Balm Watermelon SPF Octinoxate and Oxybenzone STICK TOPICAL 20111129 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc. OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g 51514-0221_74f90a1d-d5fa-45c9-9961-e8995888c4e6 51514-0221 HUMAN OTC DRUG Yes to Carrots Sweet Fig SPF15 Zinc Oxide STICK TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Autumn Harp ZINC OXIDE 6.5 g/100g 51514-0223_bc21e31a-3343-4126-ae58-401327739921 51514-0223 HUMAN OTC DRUG GAP favorite Lip Balm Green Apple SPF 18 Octinoxate and Oxybenzone STICK TOPICAL 20111206 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g 51514-0227_d70f1df9-31eb-49d2-b024-155777946247 51514-0227 HUMAN OTC DRUG GAP Favorite Lip Balm Apple Pie SPF 18 Octinoxate and Oxybenzone STICK TOPICAL 20111208 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g 51514-0235_e1218602-18ec-4010-acd9-658608a55d11 51514-0235 HUMAN OTC DRUG Babyganics SPF 50 Octinoxate, Octisalate, and Zinc SPRAY TOPICAL 20120223 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 11.2 mL/100mL; mL/100mL; mL/100mL 51514-0236_fadc97b3-9d98-49ca-8151-4d4a1784843a 51514-0236 HUMAN OTC DRUG Desert Essence Mineral Sunscreen SPF 35 Zinc Oxide CREAM TOPICAL 20130715 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 15 g/100g 51514-0251_44b6001c-6c13-4162-91a1-4ea102896315 51514-0251 HUMAN OTC DRUG Badger Unscented Broad Spectrum SPF 30 Sunscreen Zinc Oxide CREAM TOPICAL 20130301 20150901 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 18.75 g/100mL 51514-0301_c234d1e3-b510-4599-9551-3eb7c569d546 51514-0301 HUMAN OTC DRUG Badger SPF 30 Aloe Sunscreen Zinc Oxide LOTION TOPICAL 20130301 20150501 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 12 g/100mL 51514-0303_2bab63e9-ca01-4cf7-af4e-3d2d106f9bb3 51514-0303 HUMAN OTC DRUG Alba TerraTint Bloom SPF 15 Lip Balm Zinc Oxide STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 5.5 g/100g 51514-0304_374b5d5c-2bbb-4106-a804-ff355ab75105 51514-0304 HUMAN OTC DRUG Alba TerraTint Garnet SPF 15 Lip Balm Zinc Oxide STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 5.5 g/100g 51514-0305_a1e1d4b4-9e71-4599-b3dd-920938d760d8 51514-0305 HUMAN OTC DRUG Alba TerraTint Blaze SPF 15 Lip Balm Zinc Oxide STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 5.5 g/100g 51514-0306_06100db1-4158-4b92-9413-d29cec8dcc13 51514-0306 HUMAN OTC DRUG Alba Very Emollient Sunscreen Lip Care SPF25 Octocrylene, Octinoxate, Octisalate, Zinc Oxide STICK TOPICAL 20120401 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 7.5; 1; 10; 3.7 g/100g; g/100g; g/100g; g/100g 51514-0307_8b61ef0a-ae74-4347-8cfd-52da928fb227 51514-0307 HUMAN OTC DRUG YesTo Pomegranate Lip Butter with SPF 15 Zinc Oxide STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 7.6 g/100g 51514-0308_379446ad-e89c-4f6a-97fd-c374c4a312b1 51514-0308 HUMAN OTC DRUG Badger SPF 35 Sport Sunscreen Zinc Oxide STICK TOPICAL 20110201 20160601 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 22.5 g/100g 51514-0309_a509e96e-6ecd-471f-ae22-5244eb674b7b 51514-0309 HUMAN OTC DRUG Badger SPF 34 Anti-Bug Sunscreen Zinc Oxide LOTION TOPICAL 20111010 20150901 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 20 g/100mL 51514-0310_98e927c5-9ea3-46bc-92c6-c165c9033cf4 51514-0310 HUMAN OTC DRUG Badger SPF 30 Kids Sunscreen Zinc Oxide CREAM TOPICAL 20130218 20150701 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 18.75 g/100mL 51514-0311_70c8863f-bdc0-4dee-b7bd-50a9bda01ff2 51514-0311 HUMAN OTC DRUG Badger SPF 30 Baby Sunscreen Zinc Oxide CREAM TOPICAL 20130318 20150901 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 18.75 g/100mL 51514-0312_87fa5639-a08b-4d93-971d-c1fd67c94165 51514-0312 HUMAN OTC DRUG Badger SPF 35 Sport Sunscreen Zinc Oxide CREAM TOPICAL 20130318 20150901 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 22.5 g/100mL 51514-0313_f81b10f7-bb32-4e45-89ab-d8d3492e153c 51514-0313 HUMAN OTC DRUG Badger Zinc Oxide Diaper Zinc Oxide CREAM TOPICAL 20130318 20160101 OTC MONOGRAPH FINAL part347 Autumn Harp, Inc. ZINC OXIDE 10 g/100mL 51514-0314_eeb12162-6aed-4c73-81d5-bb8b5b2f42c0 51514-0314 HUMAN OTC DRUG Badger SPF 15 Sunscreen Lip Balm Zinc Oxide STICK TOPICAL 20120611 20160501 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 8 g/100g 51514-0315_8f3e090a-3d0e-479c-ac5b-8a3dd69ecc00 51514-0315 HUMAN OTC DRUG Yes To Cucumbers Natural Sunscreen SPF 30 Stick Zinc Oxide, Titanium Dioxide STICK TOPICAL 20130111 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. TITANIUM DIOXIDE; ZINC OXIDE 4.9; 10.8 g/100g; g/100g 51514-0316_2d684392-63bd-4cc6-8412-7d12b244680b 51514-0316 HUMAN OTC DRUG Yes To Cucumbers Natural Sunscreen SPF 40 Kids Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20121230 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. TITANIUM DIOXIDE; ZINC OXIDE 5.5; 11.7 g/100mL; g/100mL 51514-0317_758659ed-1519-4a12-b5ca-b510344486c5 51514-0317 HUMAN OTC DRUG Yes To Grapefruit Moisturizer with SPF15 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20121114 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. TITANIUM DIOXIDE; ZINC OXIDE 2.9; 3.2 mg/100mL; mg/100mL 51514-0318_d806c4c7-0eaa-47bf-a424-0bdfe08f3a43 51514-0318 HUMAN OTC DRUG Yes To Cucumbers Natural Sunscreen SPF 30 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20130101 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. TITANIUM DIOXIDE; ZINC OXIDE 6.2; 11 g/100g; g/100g 51514-0319_aab342e3-7422-4699-8a16-73191285480b 51514-0319 HUMAN OTC DRUG Urban Decay Naked Skin Beauty Balm SPF 20 Octinoxate, Zinc Oxide LOTION TOPICAL 20130712 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. OCTINOXATE; ZINC OXIDE 7.5; 3.4 mg/100mL; mg/100mL 51514-0320_3a48f672-c3fe-4ade-9549-a7bf7552aeb7 51514-0320 HUMAN OTC DRUG Yes To Carrots Sweet Fig Lip Butter with SPF 15 Zinc Oxide STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc ZINC OXIDE 7.6 g/100g 51514-0321_01072a9e-6de2-4c1b-ac13-f980994516bd 51514-0321 HUMAN OTC DRUG Yes To Cucumbers Daily Moisturizer SPF 30 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20130206 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. TITANIUM DIOXIDE; ZINC OXIDE 6.2; 11 mg/100mL; mg/100mL 51514-0322_a27a7f76-5ba8-4258-a9fa-a346075c5cd3 51514-0322 HUMAN OTC DRUG Yes To Blueberries Daily Repairing Moisturizer SPF30 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20130322 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. TITANIUM DIOXIDE; ZINC OXIDE 6.2; 11 mg/100mL; mg/100mL 51514-0323_94cde319-7aa2-4cbe-804e-6e911c8638f3 51514-0323 HUMAN OTC DRUG Yes To Carrots Daily Facial Moisturizer SPF 15 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20130430 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. TITANIUM DIOXIDE; ZINC OXIDE 2.9; 3.2 mg/100mL; mg/100mL 51514-0324_6e4cd232-2f23-4b65-9158-70e358035e3a 51514-0324 HUMAN OTC DRUG YES TO GRAPEFRUIT CC CREAM - LIGHT/MEDIUM Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130619 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc TITANIUM DIOXIDE; ZINC OXIDE 2.9; 3.2 mg/100mL; mg/100mL 51514-0325_6948797b-f5c7-4376-942d-913e9ff5a477 51514-0325 HUMAN OTC DRUG YES TO GRAPEFRUIT CC CREAM - LIGHT Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130415 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc TITANIUM DIOXIDE; ZINC OXIDE 2.9; 3.2 mg/100mL; mg/100mL 51514-0326_14a16b35-c86b-4368-806e-bc38c973c94a 51514-0326 HUMAN OTC DRUG YES TO CARROTS FRAGRANCE-FREE DAILY FACIAL MOISTURIZER SPF15 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130613 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc TITANIUM DIOXIDE; ZINC OXIDE 2.9; 3.2 mg/100mL; mg/100mL 51514-0327_52a0349e-f327-4681-9491-d38cf5ce7776 51514-0327 HUMAN OTC DRUG YES TO TOMATOES ROLLER BALL SPOT STICK Salicylic Acid SOLUTION TOPICAL 20110112 OTC MONOGRAPH FINAL part333D Autumn Harp, Inc. SALICYLIC ACID 2 mg/100mL 51514-0328_5de6b069-fa7b-42fa-a68e-64b28fa9c07b 51514-0328 HUMAN OTC DRUG YES TO TOMATOES DAILY PORE SCRUB Salicylic Acid CREAM TOPICAL 20110113 OTC MONOGRAPH FINAL part333D Autumn Harp, Inc. SALICYLIC ACID 2 g/100g 51514-0329_b2166f8a-0db3-4a61-8827-41d7ea4cac41 51514-0329 HUMAN OTC DRUG YES TO TOMATOES ACNE CONTROL GEL CLEANSER Salicylic Acid GEL TOPICAL 20111027 OTC MONOGRAPH FINAL part333D Autumn Harp, Inc. SALICYLIC ACID 1 g/100mL 51514-0330_f5e8b855-707e-4624-86e3-c1b85f5e41dd 51514-0330 HUMAN OTC DRUG Yes To Tomatoes Daily Repair Treatment Salicylic Acid GEL TOPICAL 20130411 OTC MONOGRAPH FINAL part333D Autumn Harp, Inc. SALICYLIC ACID 1 mg/100mL 51514-0331_6ac92a0a-fcc0-4c05-8bee-d741f46afbb5 51514-0331 HUMAN OTC DRUG Urban Decay Naked Skin Light Beauty Balm SPF20 Octinoxate, Zinc Oxide LOTION TOPICAL 20140109 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. OCTINOXATE; ZINC OXIDE 7.5; 3.4 mg/100mL; mg/100mL 51514-0332_ded5c521-cdfa-4c5f-8f84-5fd202204a52 51514-0332 HUMAN OTC DRUG Josie Maran Argan Daily Moisturizer SPF47 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20140109 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. TITANIUM DIOXIDE; ZINC OXIDE 5.1; 6.4 mg/100mL; mg/100mL 51514-0333_3be87ace-b30b-4b05-b4d8-fd4aa4f0eb8d 51514-0333 HUMAN OTC DRUG Urban Decay Naked Skin Dark Beauty Balm SPF20 Octinoxate, Zinc Oxide LOTION TOPICAL 20130805 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. OCTINOXATE; ZINC OXIDE 7.5; 3.4 mg/100mL; mg/100mL 51514-0334_08b4927b-8b1d-3061-e054-00144ff8d46c 51514-0334 HUMAN OTC DRUG Urban Decay Naked Skin Bronzing Beauty Balm SPF 20 Octinoxate, Zinc Oxide LOTION TOPICAL 20130927 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. OCTINOXATE; ZINC OXIDE 7.5; 3.4 mg/100mL; mg/100mL 51514-0335_08b4927b-8b2e-3061-e054-00144ff8d46c 51514-0335 HUMAN OTC DRUG Urban Decay Naked Skin Illuminating Beauty Balm SPF20 Octinoxate, Zinc Oxide LOTION TOPICAL 20130805 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. OCTINOXATE; ZINC OXIDE 7.5; 3.4 mg/100mL; mg/100mL 51514-0336_3153033b-7552-4484-a4db-f403330ef2ee 51514-0336 HUMAN OTC DRUG LIP CARE SPF 15 WITH VITAMIN E Octinoxate, Oxybenzone STICK TOPICAL 20040820 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. OCTINOXATE; OXYBENZONE 7.5; 5 g/100g; g/100g 51514-0337_2865f218-0c89-4b93-a811-39bad63cdc67 51514-0337 HUMAN OTC DRUG Josie Maran Argan Daily Moisturizer SPF47 Protect and Perfect Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20140305 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. TITANIUM DIOXIDE; ZINC OXIDE 5.9; 9.4 mg/100mL; mg/100mL 51514-0338_086b6d24-c552-4eb2-a405-ff1be677af5f 51514-0338 HUMAN OTC DRUG Desert Essence Dont Be Rash Diaper Cream Zinc Oxide CREAM TOPICAL 20110609 OTC MONOGRAPH FINAL part347 Autumn Harp, Inc. ZINC OXIDE 12 g/100mL 51514-0339_05f3d444-93fb-54a7-e054-00144ff8d46c 51514-0339 HUMAN OTC DRUG Yes To Tomatoes Clear Skin Corrective Concealer Light Tint Salicylic Acid Concealer Stick STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part333D Autumn Harp Incorporated SALICYLIC ACID 1 g/100g 51514-201_06b61907-1137-428b-983c-6b87daf0becb 51514-201 HUMAN OTC DRUG Badger SPF30 Unscented Sunscreen Unscented Zinc Oxide OINTMENT TOPICAL 20111110 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc. ZINC OXIDE 18.75 mL/100mL 51523-001_326d3e0f-a911-4b28-a706-e18dee450dc1 51523-001 HUMAN OTC DRUG ARSAINTE ECO THERAPY SUPER REPAIR BB SPF20 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 4.64 mL/50mL 51523-002_1c49c462-a7be-48b9-8b25-cce51f3aa1ff 51523-002 HUMAN OTC DRUG ARSAINTE ECO THERAPY SUPER REPAIR SUN SPF45 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 5.55; 4.36 mL/50mL; mL/50mL 51523-003_5cb718c5-33a1-4522-9b06-3ad7e5123cad 51523-003 HUMAN OTC DRUG QUICK AND CLEAN OIL FREE SUN SPF35 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20090101 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 2.59 g/50g 51523-004_26511f13-52e4-4f15-af38-3b84e0fff4c3 51523-004 HUMAN OTC DRUG FLEBEAUTE COLLAGENIC FOUNDATION SPF20 PA NB21 TITANIUM DIOXIDE CREAM CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 4.01 mL/35mL 51523-005_8e6610c1-c1be-4740-b692-322f14c94bd0 51523-005 HUMAN OTC DRUG FLEBEAUTE COLLAGENIC FOUNDATION SPF20 PA NB23 TITANIUM DIOXIDE CREAM CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 4.01 mL/35mL 51523-006_932f99eb-aafe-40f6-99cf-f81692002fca 51523-006 HUMAN OTC DRUG FLEBEAUTE COLLAGENIC MAKE UP BASE SPF20 PA 01GREEN TITANIUM DIOXIDE CREAM CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.81; 1.41 mL/35mL; mL/35mL 51523-007_ff93b65a-7905-421b-ad13-9edf024362d1 51523-007 HUMAN OTC DRUG FLEBEAUTE COLLAGENIC SKIN COVER SPF20 PA NB21 TITANIUM DIOXIDE CREAM CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 2.35 g/10g 51523-008_b104d6e5-9452-4844-806f-3f5dfa86dbde 51523-008 HUMAN OTC DRUG FLEBEAUTE COLLAGENIC SKIN COVER SPF20 PA NB23 TITANIUM DIOXIDE POWDER CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 2.35 g/10g 51523-009_78671884-de9d-485e-88b0-d4c2a329d96d 51523-009 HUMAN OTC DRUG FLEBEAUTE COLLAGENIC TWO WAY CAKE SPF17 PA NB21 TITANIUM DIOXIDE POWDER CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE .93; .17 g/12g; g/12g 51523-010_68540c8a-bb3a-40cc-aa8c-c551b6c1fee1 51523-010 HUMAN OTC DRUG FLEBEAUTE COLLAGENIC TWO WAY CAKE SPF17 PA NB23 TITANIUM DIOXIDE POWDER CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE .93; .17 g/12g; g/12g 51523-011_1db6323e-7193-4e31-886b-098710b42e53 51523-011 HUMAN OTC DRUG FLEBEAUTE COLLAGENIC TWO WAY CAKE SPF17 PA NB25 TITANIUM DIOXIDE POWDER CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE .93; .17 g/12g; g/12g 51523-012_2c75cdc9-d568-4d54-84d5-9447395ebd7f 51523-012 HUMAN OTC DRUG HYDRO SPLASH BB SPF20 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 4.48 g/45g 51523-013_a8fe4224-534a-4f74-98c4-45bc52b9b7be 51523-013 HUMAN OTC DRUG MYUNG HAN MI IN DO FOUNDATION SPF20 PA NB21 TITANIUM DIOXIDE CREAM CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 4.01 mL/35mL 51523-014_a08b3f2d-8b73-46b7-b350-913f866bf3ad 51523-014 HUMAN OTC DRUG MYUNG HAN MI IN DO FOUNDATION SPF20 PA NB23 TITANIUM DIOXIDE CREAM CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 4.01 mL/35mL 51523-015_b26e4159-a3cb-4abd-a433-4fb62bd96d57 51523-015 HUMAN OTC DRUG MYUNG HAN MI IN DO MAKEUP BASE SPF20 PA 01 GREEN TITANIUM DIOXIDE CREAM CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 1.19 mL/35mL 51523-016_51bee26b-ae24-4de9-b97b-059bf85590ff 51523-016 HUMAN OTC DRUG MYUNG HAN MI IN DO RECOVERY BB SPF25 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.87; .86 g/45g; g/45g 51523-017_e8b24316-a3a8-47c8-9d06-5cac7e3d58e7 51523-017 HUMAN OTC DRUG MYUNG HAN MI IN DO TWO WAY CAKE SPF35 PA NB21 TITANIUM DIOXIDE POWDER CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.02; .35 g/12g; g/12g 51523-018_5644ca3b-0bc1-47a1-9e91-642c28bac555 51523-018 HUMAN OTC DRUG MYUNG HAN MI IN DO TWO WAY CAKE SPF35 PA NB23 TITANIUM DIOXIDE POWDER CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.02; .35 g/12g; g/12g 51523-019_77bfc4ad-f2e5-4f77-a0f0-2de3c43cc780 51523-019 HUMAN OTC DRUG NEO CLASSIC HOMME BB SPF20 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 1.45 mL/50mL 51523-020_a7768b4b-d439-47de-9ded-8b3f8757b13d 51523-020 HUMAN OTC DRUG NATURAL SUN AQ POWER LONG LASTING SUN SPF45 PA ZINC OXIDE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.25; 5.5 mL/50mL; mL/50mL 51523-021_f12a8cdc-3f0c-45b1-bdc1-ba31fbe2e441 51523-021 HUMAN OTC DRUG NATURAL SUN AQ SUPER PERFECT SUN SPF50 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 1.36 mL/50mL 51523-022_4c2ad6f4-78e0-4d04-83d2-67011e511480 51523-022 HUMAN OTC DRUG NATURAL SUN AQ SUPER WHITE SUN SPF50 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 1.36 mL/50mL 51523-023_60b44338-edd9-4ea6-b125-17940fd7e140 51523-023 HUMAN OTC DRUG THE FLOWER UV INTENSE PACT SPF50 PA NB21 ZINC OXIDE POWDER CUTANEOUS 20070301 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.53; 1.64 g/12g; g/12g 51523-024_857b67c5-e604-4d28-94d6-39ef99413919 51523-024 HUMAN OTC DRUG THE FLOWER UV INTENSE PACT SPF50 PA NB23 ZINC OXIDE POWDER CUTANEOUS 20070301 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.54; 1.65 g/12g; g/12g 51523-025_e931f1f2-3e97-465f-8745-f37bc631bdbe 51523-025 HUMAN OTC DRUG THE SKIN EXTRA BB SPF20 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20090101 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE .81 g/45g 51523-026_76a14fab-5160-45f3-978b-42232285ad67 51523-026 HUMAN OTC DRUG PHYTOGENIC INFINITE FOUNDATION SPF20 NB21 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 3.25 mL/35mL 51523-027_15b5fecd-0b4d-4851-a8b8-bfa3e8dd9847 51523-027 HUMAN OTC DRUG PHYTOGENIC INFINITE FOUNDATION SPF20 NB23 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 3.25 mL/35mL 51523-028_125c26f7-a54a-49c3-a1d8-dd90ddaf8e2e 51523-028 HUMAN OTC DRUG PHYTOGENIC INFINITE FOUNDATION SPF20 NB25 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 3.25 mL/35mL 51523-029_4fb22d75-0019-417d-9381-3840a6847bca 51523-029 HUMAN OTC DRUG PHYTOGENIC INFINITE MAKEUP BASE SPF15 GREEN TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.23; .93 mL/35mL; mL/35mL 51523-030_d4808c5b-c3af-4a3e-96fa-6391eda39b8a 51523-030 HUMAN OTC DRUG PHYTOGENIC INFINITE MAKEUP BASE SPF15 PURPLE TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.23; .93 mL/35mL; mL/35mL 51523-031_0c572d40-83f7-40bb-ab4a-90eaf4a46dfc 51523-031 HUMAN OTC DRUG PHYTOGENIC INFINITE POWDER FOUNDATION SPF20 NB21 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 1.68 g/12g 51523-032_7beab07e-971f-4403-b66d-5f5d94f89e28 51523-032 HUMAN OTC DRUG PHYTOGENIC INFINITE POWDER FOUNDATION SPF20 RB23 TITANIUM DIOXIDE POWDER CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 1.68 g/12g 51523-033_e1bca880-9091-4fab-9b4e-a5b2990d7d3a 51523-033 HUMAN OTC DRUG PHYTOGENIC INFINITE POWDER FOUNDATION SPF20 NB25 TITANIUM DIOXIDE POWDER CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 1.68 g/12g 51523-034_84df31bc-88fa-4b6d-88c7-7b90dbf4bbd8 51523-034 HUMAN OTC DRUG PHYTOGENIC INFINITE POWDER FOUNDATION SPF20 NB23 TITANIUM DIOXIDE POWDER CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 1.68 g/12g 51523-100_df137887-b544-427f-a316-61f3cb43afab 51523-100 HUMAN OTC DRUG Myung Han Miindo Make Up Base OCTINOXATE LIQUID TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD AVOBENZONE; ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE .8; 2; 6; 3.4 mL/100mL; mL/100mL; mL/100mL; mL/100mL 51523-101_b7e93fdb-4412-4271-b379-8d07992f0e82 51523-101 HUMAN OTC DRUG NATURAL SUN AQ BODY AND FAMILY MILD SUN MILK OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AVOBENZONE, ENZACAMENE CREAM TOPICAL 20101122 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD AVOBENZONE; ENZACAMENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 2.3; 2; 7.5; 3; 2.34 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 51523-102_18ca4674-e8d7-47f8-847f-74bf1c0cef9b 51523-102 HUMAN OTC DRUG NATURAL SUN AQ TOTAL ANTI-AGING ESSENCE SUN OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AVOBENZONE, ENZACAMENE, NIACINAMIDE, ADENOSINE CREAM TOPICAL 20101122 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD ADENOSINE; AVOBENZONE; ENZACAMENE; NIACINAMIDE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .4; 2.3; 2; 2; 7.5; 3; 2.34 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 51523-103_0ccce2d2-82a7-4e12-a2e5-7ffce3cd5aba 51523-103 HUMAN OTC DRUG FACE IT HD PERFECT BB SPF30 PA 01 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, BETAINE, TALC CREAM TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD BETAINE; OCTINOXATE; TALC; TITANIUM DIOXIDE; ZINC OXIDE 2; 6; .684; 6.36; 2.88 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 51523-104_bea9f699-bc6f-4b53-b4f5-8be1d1f2f91b 51523-104 HUMAN OTC DRUG FACE IT HD PERFECT BB SPF30 PA 02 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, BETAINE, TALC CREAM TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD BETAINE; OCTINOXATE; TALC; TITANIUM DIOXIDE; ZINC OXIDE 2; 6; .684; 6.36; 2.88 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 51523-105_97b6d7bf-8212-4a0d-9a6b-5bacaaaf2fa8 51523-105 HUMAN OTC DRUG FACE IT AQUA TINTED BB SPF 20 PA 01 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE 5; 5.8 mL/100mL; mL/100mL 51523-106_0d7fea65-9b75-4cac-896f-3fd0753db2bf 51523-106 HUMAN OTC DRUG FACE IT AQUA TINTED BB SPF 20 PA 02 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE 5; 5.8 mL/100mL; mL/100mL 51523-109_5c154dbd-714f-4821-8535-3494703f8561 51523-109 HUMAN OTC DRUG FACE IT 4D PERFECTION ROLLER FOUNDATION 21 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE 3; 23.51 g/100g; g/100g 51523-110_96db1182-bb49-4764-b468-5ff9c1b62712 51523-110 HUMAN OTC DRUG FACE IT 4D PERFECTION ROLLER FOUNDATION 23 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE 3; 23.51 g/100g; g/100g 51523-111_8dd2bd05-23cb-4497-8e21-04bff43b7e19 51523-111 HUMAN OTC DRUG FACE IT OIL CUT DUAL BB EMULSION SPF20 TITANIUM DIOXIDE CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD TITANIUM DIOXIDE 10 mL/100mL 51523-112_167fa68f-dfcf-4fd2-86df-4c1e8a23290e 51523-112 HUMAN OTC DRUG FACE IT Radiance Two Way Cake NB21 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2; 12.8784; 1.4775 g/100g; g/100g; g/100g 51523-113_31810c0e-b24c-43dc-817f-b00b89384bc9 51523-113 HUMAN OTC DRUG FACE IT Radiance Two Way Cake NB23 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2; 12.8784; 1.4775 g/100g; g/100g; g/100g 51523-114_faccf869-9a33-46fb-9234-1aee0a1137b7 51523-114 HUMAN OTC DRUG Lovely ME EX BB PACT SPF20 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE 2; 13.852 g/100g; g/100g 51523-115_76b3f6f6-0a09-4755-a42e-ed6f2b99f0dd 51523-115 HUMAN OTC DRUG FACE IT 4D PERPECT TWO-WAY CAKE NB21 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20110909 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.5; 13.96843; 4.41 g/100g; g/100g; g/100g 51523-116_29bd2103-7f07-4089-ac8d-c12a743b357c 51523-116 HUMAN OTC DRUG FACE IT 4D PERPECT TWO-WAY CAKE NB23 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20110909 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.5; 13.96843; 4.41 g/100g; g/100g; g/100g 51523-117_48ec60f8-ccfe-4ec4-8424-f02c29cc876c 51523-117 HUMAN OTC DRUG FACE IT RADIANCE POWDER PACT SPF25 MOISTURE VEIL NB17 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110909 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4; 6.208; 1.96 mL/100mL; mL/100mL; mL/100mL 51523-118_d3245728-b219-4ef7-b504-33d58b08abc3 51523-118 HUMAN OTC DRUG FACE IT RADIANCE FOUNDATION SPF20 NB21 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20110913 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE 4.5; 11.476 mL/100mL; mL/100mL 51523-119_15ee65da-cb07-4e63-b647-c17e18eaa350 51523-119 HUMAN OTC DRUG FACE IT RADIANCE FOUNDATION SPF20 NB23 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20110913 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE 4.5; 11.476 mL/100mL; mL/100mL 51523-120_c19787cc-cc28-4db4-a8ea-6686a9018d07 51523-120 HUMAN OTC DRUG FACE IT RADIANCE POWDER PACT SPF25 MOISTURE VEIL NB17 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20110913 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4; 6.208; 1.96 g/100g; g/100g; g/100g 51523-121_e385684f-c88e-48af-9827-1d886798b0ec 51523-121 HUMAN OTC DRUG FACE IT RADIANCE POWDER PACT SPF25 MOISTURE VEIL NB21 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20110913 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4; 6.208; 1.96 g/100g; g/100g; g/100g 51523-122_9492aeed-3634-4020-9f3c-4aafbd656c0b 51523-122 HUMAN OTC DRUG FACE IT RADIANCE POWDER PACT SPF25 MOISTURE VEIL NB23 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20110913 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4; 6.208; 1.96 g/100g; g/100g; g/100g 51525-0294_4c14495f-3f89-4602-bd98-6c7baa4950f6 51525-0294 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride Azelastine Hydrochloride SPRAY, METERED NASAL 20100701 NDA AUTHORIZED GENERIC NDA020114 Wallace Pharmaceuticals Inc. AZELASTINE HYDROCHLORIDE 137 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 51525-0430_d1c250e0-15f1-11e1-a719-0002a5d5c51b 51525-0430 HUMAN PRESCRIPTION DRUG Felbamate felbamate TABLET ORAL 20111111 NDA AUTHORIZED GENERIC NDA020189 Wallace Pharmaceuticals Inc. FELBAMATE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51525-0431_d1c250e0-15f1-11e1-a719-0002a5d5c51b 51525-0431 HUMAN PRESCRIPTION DRUG Felbamate felbamate TABLET ORAL 20111111 NDA AUTHORIZED GENERIC NDA020189 Wallace Pharmaceuticals Inc. FELBAMATE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51525-0442_d1c250e0-15f1-11e1-a719-0002a5d5c51b 51525-0442 HUMAN PRESCRIPTION DRUG Felbamate felbamate SUSPENSION ORAL 20111123 NDA AUTHORIZED GENERIC NDA020189 Wallace Pharmaceuticals Inc. FELBAMATE 600 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51525-5901_251f0084-e7ae-11e1-aff1-0800200c9a66 51525-5901 HUMAN PRESCRIPTION DRUG Carisoprodol carisoprodol TABLET ORAL 20100701 NDA AUTHORIZED GENERIC NDA011792 Wallace Pharmaceuticals Inc. CARISOPRODOL 250 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 51525-6831_486598b0-0358-11e3-8ffd-0800200c9a66 51525-6831 HUMAN PRESCRIPTION DRUG TriLyte with Flavor Packs Polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride POWDER, FOR SOLUTION NASOGASTRIC; ORAL 20130923 ANDA ANDA076491 Wallace Pharmaceuticals Inc. POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420; 1.48; 5.72; 11.2 g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 51525-7815_edbf877a-80ef-412b-9d77-cc67d2850fb3 51525-7815 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS INTRAOCULAR 20101001 NDA AUTHORIZED GENERIC NDA021127 Wallace Pharmaceuticals Inc. AZELASTINE HYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 51531-0288_b1359c9f-4d4f-4208-bac0-aceab9a09291 51531-0288 HUMAN OTC DRUG MKMen Advanced Facial Hydrator Sunscreen SPF 30 avobenzone, homosalate, octisalate, octocrylene, oxybenzone LOTION TOPICAL 20130516 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 51531-0332_b637bf3f-b40e-499e-968d-4260517cef59 51531-0332 HUMAN OTC DRUG MKMen Moisturizer Sunscreen Broad Spectrum SPF 25 avobenzone, homosalate, octinoxate, octisalate, oxybenzone LOTION TOPICAL 20070616 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 10; 7.5; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 51531-0349_d7f7c12c-0bf0-4753-8c79-38e146ba152b 51531-0349 HUMAN OTC DRUG Mary Kay Suncare Sunscreen SPF 30 avobenzone, homosalate, octinoxate, octisalate, oxybenzone LOTION TOPICAL 20070316 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 10; 7.5; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 51531-0813_f676f9d0-15ff-4586-919e-c1e08170a27c 51531-0813 HUMAN OTC DRUG Mary Kay Acne Treatment Acne Medication Benzoyl Peroxide GEL TOPICAL 19880119 OTC MONOGRAPH FINAL part333D Mary Kay Inc. BENZOYL PEROXIDE 5 g/100g 51531-0838_e7448121-edc4-4a24-b88c-c955cfbdbf40 51531-0838 HUMAN OTC DRUG Mary Kay Blemish Control Toner Acne Medication Salicylic Acid SOLUTION TOPICAL 19880119 OTC MONOGRAPH FINAL part333D Mary Kay Inc. SALICYLIC ACID 2 g/100mL 51531-0850_acca6d11-87a8-4963-aa33-2fc9a99c3869 51531-0850 HUMAN OTC DRUG Mary Kay Foundation Primer avobenzone, homosalate, octisalate, octocrylene GEL TOPICAL 20120301 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 9; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL 51531-1349_81a35520-79e6-4621-969a-6719f1580ac9 51531-1349 HUMAN OTC DRUG Clear Proof Clarifying Cleansing Gel Acne Medication Salicylic Acid GEL TOPICAL 20130815 OTC MONOGRAPH FINAL part333D Mary Kay Inc. SALICYLIC ACID 2 g/100g 51531-2326_3abec8b9-b0ed-4e97-904c-4853004f73ec 51531-2326 HUMAN OTC DRUG Mary Kay TimeWise Day Solution Sunscreen SPF 25 octinoxate, octisalate, zinc oxide, oxybenzone, LOTION TOPICAL 20051216 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 7.5; 5; 3; 3.88 g/100mL; g/100mL; g/100mL; g/100mL 51531-2822_67912b9c-cdf9-4fda-a845-7a1de2fa25a4 51531-2822 HUMAN OTC DRUG Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Light homosalate, octinoxate, oxybenzone CREAM TOPICAL 20140216 OTC MONOGRAPH FINAL part352 Mary Kay Inc. HOMOSALATE; OCTINOXATE; OXYBENZONE 5; 6.5; 1.2 g/100mL; g/100mL; g/100mL 51531-2823_620cda6a-5f7c-42a3-98dd-ed0dab7681e5 51531-2823 HUMAN OTC DRUG Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to Medium homosalate, octinoxate, oxybenzone CREAM TOPICAL 20140216 OTC MONOGRAPH FINAL part352 Mary Kay Inc. HOMOSALATE; OCTINOXATE; OXYBENZONE 5; 6.5; 1.2 g/100mL; g/100mL; g/100mL 51531-2824_e79631f7-1196-4f54-830b-2590d6c740f4 51531-2824 HUMAN OTC DRUG Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to Deep homosalate, octinoxate, oxybenzone CREAM TOPICAL 20140216 OTC MONOGRAPH FINAL part352 Mary Kay Inc. HOMOSALATE; OCTINOXATE; OXYBENZONE 5; 6.5; 1.2 g/100mL; g/100mL; g/100mL 51531-2825_052ce1fc-3523-404f-b3f3-5d216ca2311d 51531-2825 HUMAN OTC DRUG Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Deep homosalate, octinoxate, oxybenzone CREAM TOPICAL 20140216 OTC MONOGRAPH FINAL part352 Mary Kay Inc. HOMOSALATE; OCTINOXATE; OXYBENZONE 5; 6.5; 1.2 g/100mL; g/100mL; g/100mL 51531-4102_829f9d50-d3e9-4958-b06c-1bcf32e7869f 51531-4102 HUMAN OTC DRUG Mary Kay TimeWise Age Fighting Moisturizer SPF 30 avobenzone, homosalate, octisalate, octocrylene, oxybenzone LOTION TOPICAL 20120316 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 51531-4160_c4e3b9c8-b214-4f93-8c11-3cafbb5632e9 51531-4160 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Peach octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20110616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g 51531-4161_fcdae00b-e96c-40ec-9e66-5dea9ca6681c 51531-4161 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Peony octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20110616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g 51531-4162_4214370d-551a-4ffb-8d77-f4161bb64c42 51531-4162 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Berry octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20110616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g 51531-4163_13ef0b02-6846-4f50-8034-8bc353c0d71f 51531-4163 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Cherry octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20110616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g 51531-4189_6769f6f0-8310-440c-aceb-e11f97d7790d 51531-4189 HUMAN OTC DRUG Foundation Primer SPF 15 Titanium Dioxide , Zinc Oxide , Octinoxate CREAM TOPICAL 20091111 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .7; .222; 2.73 g/14g; g/14g; g/14g 51531-4250_dff78c4a-d1d9-440b-86f7-d12404201806 51531-4250 HUMAN OTC DRUG Mary Kay Suncare Sunscreen Broad Spectrum SPF 50 avobenzone, homosalate, octisalate, octocrylene, oxybenzone LOTION TOPICAL 20120316 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 51531-4325_cd7e9252-678d-4951-b1bd-7567bae77a3d 51531-4325 HUMAN OTC DRUG Mary Kay TimeWise Body Hand and Decolette Cream SPF 15 avobenzone, octisalate, octocrylene, oxybenzone CREAM TOPICAL 20100315 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 2.2; 3 g/100g; g/100g; g/100g; g/100g 51531-4328_d62e4b7a-4532-4f7c-a314-a1ff3deb36e3 51531-4328 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Ivory 1 (Drug Facts) octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20120612 OTC MONOGRAPH FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 7.5; 5; 1.75; 2.43 g/100mL; g/100mL; g/100mL; g/100mL 51531-4329_4065fcad-96ab-4c9f-8824-639bdb6b9258 51531-4329 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Ivory 2 (Drug Facts) octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20120612 OTC MONOGRAPH FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 7.5; 5; 1.75; 2.43 g/100mL; g/100mL; g/100mL; g/100mL 51531-4330_2b9a7e40-59be-47ec-85d2-a1cb01b99301 51531-4330 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Beige 1 (Drug Facts) octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20120612 OTC MONOGRAPH FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 7.5; 5; 1.75; 2.43 g/100mL; g/100mL; g/100mL; g/100mL 51531-4331_40b5755b-5f5b-49b3-a9be-70d30f74aaf1 51531-4331 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Beige 2 (Drug Facts) octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20120612 OTC MONOGRAPH FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 7.5; 5; 1.75; 2.43 g/100mL; g/100mL; g/100mL; g/100mL 51531-4332_b16ee921-fde2-49ce-900b-508d2b3a43ef 51531-4332 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Bronze 1 (Drug Facts) octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20120612 OTC MONOGRAPH FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 7.5; 5; 1.75; 2.43 g/100mL; g/100mL; g/100mL; g/100mL 51531-4333_0095e08f-dc9a-48a9-bd8f-0eb63f878d8d 51531-4333 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Bronze 2 (Drug Facts) octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20120612 OTC MONOGRAPH FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 7.5; 5; 1.75; 2.43 g/100mL; g/100mL; g/100mL; g/100mL 51531-4399_42b92073-be1c-4abd-9966-7d3026aec5c6 51531-4399 HUMAN OTC DRUG Mary Kay TimeWise Repair VoluFirm Day Cream SPF 30 avobenzone, homosalate, octisalate, octocrylene, oxybenzone CREAM TOPICAL 20120716 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g 51531-5393_ad796220-b224-42a2-aff9-7becbe716662 51531-5393 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Rose octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20090616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g 51531-5394_7c1ecfae-5d10-4a52-b57b-17e493bc4bb6 51531-5394 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Mango octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20090616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g 51531-5395_ff531a89-da5d-454f-8728-440ee26c99d0 51531-5395 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Apricot octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20090616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g 51531-5396_7aec7349-0891-40d3-a7c4-874634b39bd3 51531-5396 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Poppy octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20090616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g 51531-5397_38f03867-b1f5-4cd6-a840-7521f79ac8c9 51531-5397 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Fig octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20090616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g 51531-5748_aff46d4c-5685-436e-895f-25bff61721b0 51531-5748 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Blush octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20090616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g 51531-5749_fb7a89de-d382-4ec8-b570-8e5897d86b90 51531-5749 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Natural octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20090616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g 51531-6743_e05904f2-ce35-4223-a06a-98a6a9876753 51531-6743 HUMAN OTC DRUG Clear Proof Blemish Control Toner Acne Medication Salicylic Acid LIQUID TOPICAL 20130815 OTC MONOGRAPH FINAL part333D Mary Kay Inc. SALICYLIC ACID 2 g/100mL 51531-7472_657f5afa-b850-4adc-9d3c-75a3a438dc8b 51531-7472 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Ivory 1 octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20060816 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 7.5; 5; 1.75; 2.4 g/100mL; g/100mL; g/100mL; g/100mL 51531-7481_d9bedf08-74ad-4dc8-8418-f952bfa653e7 51531-7481 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Ivory 2 octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20060816 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 7.5; 5; 1.75; 2.4 g/100mL; g/100mL; g/100mL; g/100mL 51531-7487_6def08dd-a088-4f17-9322-72c17c35f9f0 51531-7487 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Beige 1 octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20060816 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 7.5; 5; 1.75; 2.4 g/100mL; g/100mL; g/100mL; g/100mL 51531-7493_5937cfb0-bc0e-4d59-82aa-0fee8f846051 51531-7493 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Beige 2 octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20060816 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 7.5; 5; 1.75; 2.4 g/100mL; g/100mL; g/100mL; g/100mL 51531-7497_0e42411c-efa4-44af-bdbe-bb0a85da6508 51531-7497 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Bronze 1 octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20060816 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 7.5; 5; 1.75; 2.4 g/100mL; g/100mL; g/100mL; g/100mL 51531-7502_e07d035a-1686-4413-8c42-a8e5f224a90a 51531-7502 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Bronze 2 octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20060816 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 7.5; 5; 1.75; 2.4 g/100mL; g/100mL; g/100mL; g/100mL 51531-8360_6c873604-a9cc-4985-8612-cbb09b6812da 51531-8360 HUMAN OTC DRUG Mary Kay TimeWise Day Solution SPF 35 avobenzone, homosalate, octisalate, octocrylene, oxybenzone SOLUTION TOPICAL 20120301 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 51531-8363_ab14546e-9ffa-415d-9899-f2d60184b7f7 51531-8363 HUMAN OTC DRUG Timewise Day Solution sunscreen SPF 35 Homosalate,Octisalate,Oxybenzone,Octocrylene,Avobenzone CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .58; 2.9; 1.45; .58; 1.16 mL/29mL; mL/29mL; mL/29mL; mL/29mL; mL/29mL 51531-8365_1102570e-9bbc-4ffd-8f70-d4d19d02f0a7 51531-8365 HUMAN OTC DRUG Timewise Day Solution sunscreen SPF 35 14ml Homosalate,Octisalate,Oxybenzone,Octocrylene,Avobenzone CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .28; 1.4; .7; .28; .56 mL/14mL; mL/14mL; mL/14mL; mL/14mL; mL/14mL 51531-8968_0d2897dd-617a-4d25-b320-7bf2f11634ba 51531-8968 HUMAN OTC DRUG Clear Proof Acne System The Go Set Benzoyl Peroxide and Salicylic Acid KIT 20130815 OTC MONOGRAPH FINAL part333D Mary Kay Inc. 51531-8977_f69385f2-6e6d-4469-8e71-2183eddbd7a2 51531-8977 HUMAN OTC DRUG Clear Proof Acne System Benzoyl Peroxide and Salicylic Acid KIT 20130815 OTC MONOGRAPH FINAL part333D Mary Kay Inc. 51531-9059_881835ed-b9b6-4650-936f-381386e3cf3e 51531-9059 HUMAN OTC DRUG Clear Proof Pore Purifying Serum Acne Medication Salicylic Acid SOLUTION TOPICAL 20130815 OTC MONOGRAPH FINAL part333D Mary Kay Inc. SALICYLIC ACID 2 g/100g 51531-9071_a16e3889-598e-4aa5-908f-e0e44fc02156 51531-9071 HUMAN OTC DRUG Clear Proof Acne Treatment Acne Medication Benzoyl Peroxide GEL TOPICAL 20120615 OTC MONOGRAPH FINAL part333D Mary Kay Inc. BENZOYL PEROXIDE 5 g/100g 51531-9480_49358ccd-fda4-403e-8ce9-009257ad6ba9 51531-9480 HUMAN OTC DRUG Lip Protector Sunscreen SPF15 Octinoxate,Zinc Oxide,Oxybenzone LIPSTICK TOPICAL 20070301 OTC MONOGRAPH NOT FINAL part352 Mary Kay INC. OCTINOXATE; OXYBENZONE; ZINC OXIDE .338; .135; .152 g/4.5g; g/4.5g; g/4.5g 51531-9500_e3c41da1-d887-41c2-a6dd-ca4edf92e4df 51531-9500 HUMAN OTC DRUG New Lip Protector Sunscreen SPF15 Octinoxate,Avobenzone,Octocrylene LIPSTICK TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 Mary Kay INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE .1125; .09; .27 g/4.5g; g/4.5g; g/4.5g 51532-4616_98e13f2e-28ba-4fa1-a812-43d9c85b6551 51532-4616 HUMAN OTC DRUG CUT CLEANER BENZALKONIUM CHLORIDE, BENZOCAINE SWAB TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part348 Afassco Inc BENZALKONIUM CHLORIDE; BENZOCAINE .45; 22.5 mg/.45g; mg/.45g 51532-5104_4787f361-a72a-4c92-a2ed-1200205aa81f 51532-5104 HUMAN OTC DRUG MEDI-WIPES ETHYL ALCOHOL, CHLOROXYLENOL SWAB TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part333E Afassco Inc ALCOHOL; CHLOROXYLENOL .6; 7.5 g/1.5g; g/1.5g 51532-5300_1ec3eb2f-c959-4932-9d6a-51c9e718678e 51532-5300 HUMAN OTC DRUG Antiseptic benzalkonium chloride, benzocaine SPRAY TOPICAL 20120709 OTC MONOGRAPH NOT FINAL part333A Afassco Inc. BENZALKONIUM CHLORIDE; BENZOCAINE 1; 50 mg/mL; mg/mL 51532-5301_4af11d65-d82b-4275-9eb9-8f08869409af 51532-5301 HUMAN OTC DRUG Antiseptic benzalkonium chloride, benzocaine LIQUID TOPICAL 20120731 OTC MONOGRAPH NOT FINAL part333A Afassco Inc. BENZALKONIUM CHLORIDE; BENZOCAINE 1; 50 mg/mL; mg/mL 51532-5400_99b4701d-95e0-43ae-9720-98e79a68cab8 51532-5400 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20120216 OTC MONOGRAPH NOT FINAL part333A Afassco Inc. HYDROGEN PEROXIDE 30 mL/L 51532-5500_48c44dc8-210d-4b2b-94e5-42d444f219fa 51532-5500 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120216 OTC MONOGRAPH NOT FINAL part333A Afassco Inc. ISOPROPYL ALCOHOL 700 mL/L 51532-6101_aada473d-23f5-4eca-8611-d1d0bf745e7a 51532-6101 HUMAN OTC DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride LIQUID TOPICAL 20120216 OTC MONOGRAPH NOT FINAL part348 Afassco Inc. LIDOCAINE HYDROCHLORIDE 200 mL/L 51532-6103_bffdc3d0-b2e6-41a4-aaa8-4f7221095390 51532-6103 HUMAN OTC DRUG Sunfree Sunscreen Homosalate, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 Afassco HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 6; 7.5; 5; 5 mg/g; mg/g; mg/g; mg/g 51545-110_ff9f71bb-a9ed-40f7-9c83-3f95f94addb1 51545-110 HUMAN OTC DRUG Porcelana Day Skin Lightening Hydroquinone and Octinoxate CREAM TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part358A Ultimark Products LLC HYDROQUINONE; OCTINOXATE .02; .025 g/g; g/g 51545-120_4ce12125-d7c9-420e-8db8-e35d8051a488 51545-120 HUMAN OTC DRUG Porcelana Night Skin Lightening Hydroquinone CREAM TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part358A Ultimark Products LLC HYDROQUINONE .02 g/g 51545-210_e9ae697d-0d63-457c-894a-72a7b4ed6003 51545-210 HUMAN OTC DRUG Denorex Extra Strength Salicylic Acid SHAMPOO TOPICAL 20091101 OTC MONOGRAPH FINAL part358H Ultimark Products LLC SALICYLIC ACID .03 g/mL 51545-220_2cc27704-e41e-420c-b8d2-772e89013767 51545-220 HUMAN OTC DRUG Denorex Therapeutic Coal Tar and Menthol SHAMPOO TOPICAL 20091101 OTC MONOGRAPH FINAL part358H Ultimark Products LLC COAL TAR; MENTHOL .018; .015 g/mL; g/mL 51545-250_7e80dc91-21a0-4ade-94be-0c9139aba3ab 51545-250 HUMAN OTC DRUG Zincon Medicated Dandruff Pyrithione zinc SHAMPOO TOPICAL 20101101 OTC MONOGRAPH FINAL part358H Ultimark Products LLC PYRITHIONE ZINC .01 g/mL 51561-001_64be4a7c-4797-49c7-bb84-fda300554cf6 51561-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20100301 UNAPPROVED MEDICAL GAS Island Respiratory Care, Inc OXYGEN 99 L/100L 51567-001_f52effb4-3a2e-4287-b3ea-f1a816c1e892 51567-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20090101 UNAPPROVED MEDICAL GAS Oxygenworks OXYGEN 99 L/100L 51596-004_b34d453b-5109-4fbe-b4d6-78f8b0dde776 51596-004 HUMAN OTC DRUG Upset Stomach Relief to Go Bismuth subsalicylate POWDER ORAL 20110901 OTC MONOGRAPH FINAL part335 Breakthrough Products Inc. BISMUTH SUBSALICYLATE 525 mg/1 51596-005_f967a69f-b048-4776-a0b9-11562d5a1c29 51596-005 HUMAN OTC DRUG Heartburn Relief to Go Calcium carbonate POWDER ORAL 20110901 OTC MONOGRAPH FINAL part331 Breakthrough Products Inc. CALCIUM CARBONATE 1000 mg/1 51596-006_3ad5094c-8ce5-4f05-af55-f0448f06cdfb 51596-006 HUMAN OTC DRUG Critical Care Aspirin to Go aspirin POWDER ORAL 20121001 OTC MONOGRAPH NOT FINAL part343 Breakthrough Products Inc. ASPIRIN 325 mg/1 51596-007_54d1f19d-5b36-4fec-84cf-25651a1a4f2c 51596-007 HUMAN OTC DRUG Headache Relief to Go aspirin and caffeine POWDER ORAL 20121001 OTC MONOGRAPH NOT FINAL part343 Breakthrough Products Inc. ASPIRIN; CAFFEINE 325; 30 mg/1; mg/1 51596-008_11bf8091-bb9d-48a5-ba03-a6886a0da329 51596-008 HUMAN OTC DRUG Ache and Pain Relief to Go aspirin and caffeine POWDER ORAL 20121001 OTC MONOGRAPH NOT FINAL part343 Breakthrough Products Inc. ASPIRIN; CAFFEINE 650; 60 mg/1; mg/1 51596-009_8ffb4f55-f838-4a59-8894-158acb12af74 51596-009 HUMAN OTC DRUG Allergy Attack Relief to Go DIPHENHYDRAMINE HYDROCHLORIDE POWDER ORAL 20121001 OTC MONOGRAPH FINAL part341 Breakthrough Products Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 51596-010_bf6a7b84-37ef-4a46-9c3f-cf15b87648b6 51596-010 HUMAN OTC DRUG Headache Relief To Go acetaminophen and caffeine POWDER ORAL 20140715 OTC MONOGRAPH NOT FINAL part343 Breakthrough Products Inc. ACETAMINOPHEN; CAFFEINE 650; 50 mg/1; mg/1 51596-011_221e5ed2-fdc1-4d51-9cdd-aa9b5ee59429 51596-011 HUMAN OTC DRUG Headache Relief To Go acetaminophen and caffeine POWDER ORAL 20140715 OTC MONOGRAPH NOT FINAL part343 Breakthrough Products Inc. ACETAMINOPHEN; CAFFEINE 650; 50 mg/1; mg/1 51607-001_45abc662-3602-42e3-8111-11823d84b0b4 51607-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19380101 UNAPPROVED MEDICAL GAS Star Weld OXYGEN 990 mL/L 51609-0001_0e076375-c4f6-4416-990a-49f919f73818 51609-0001 HUMAN OTC DRUG rHGH Complex Arnica Montana, Deer Antler Velvet, Hepar Bovinum, HGH, IGF, Pituitary Bovinum, Thuja Occidentalis LIQUID ORAL 20120927 UNAPPROVED HOMEOPATHIC Fitness Systems Mfg Corp ARNICA MONTANA; BEEF LIVER; BOS TAURUS PITUITARY GLAND; CERVUS ELAPHUS VELVET; MECASERMIN; SOMATROPIN; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 5; 8; 6; 24; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 51613-001_424c07a3-10af-489c-8c5e-e4ad5f4dc628 51613-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS Pooch Welding Supply Company, Inc. OXYGEN 992 mL/L 51613-002_cf37de98-8ed6-48d5-81a8-50a5fd861623 51613-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS Pooch Welding Supply Company, Inc. NITROGEN 990 mL/L 51614-0001_91eef8eb-b9b1-4b7c-bef1-36f997e77779 51614-0001 HUMAN OTC DRUG Ultracare For Hands BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120622 OTC MONOGRAPH NOT FINAL part333A Coltene Whaledent Inc BENZALKONIUM CHLORIDE 1 mg/mL 51615-001_79f3c28a-8e63-4f31-8fa3-f570ee4af760 51615-001 HUMAN OTC DRUG Muscle and Joint HRX Pain Relieving Camphor OIL TOPICAL 20100701 OTC MONOGRAPH FINAL part348 Eximus Connections d/b/a Herbal Destination CAMPHOR (NATURAL) 3 mL/100mL 51619-300_7ffb6cdb-e244-8b40-70db-f9d43dd794c1 51619-300 HUMAN OTC DRUG PEPSOM SPORTS WINTERGREEN magnesium sulfate FOR SOLUTION TOPICAL 20080905 UNAPPROVED DRUG OTHER The Pepsom Group, Inc. MAGNESIUM SULFATE, UNSPECIFIED 1 kg/kg 51619-400_636a9d7b-1e6d-26a7-308e-02b04e90f703 51619-400 HUMAN OTC DRUG PEPSOM SPORTS SPEARMINT magnesium sulfate FOR SOLUTION TOPICAL 20080905 UNAPPROVED DRUG OTHER The Pepsom Group, Inc. MAGNESIUM SULFATE, UNSPECIFIED 1 kg/kg 51619-500_c25d03f1-69ed-ead7-ba1e-1c60b4d4442a 51619-500 HUMAN OTC DRUG PEPSOM SALT PEPPERMINT magnesium sulfate FOR SOLUTION TOPICAL 20070521 OTC MONOGRAPH NOT FINAL part334 The Pepsom Group, Inc. MAGNESIUM SULFATE, UNSPECIFIED 1 kg/kg 51619-600_d27f7b36-d902-d715-3120-1832bcdac4a4 51619-600 HUMAN OTC DRUG PEPSOM FLYING P EPSOM SALT magnesium sulfate FOR SOLUTION TOPICAL 20091109 OTC MONOGRAPH NOT FINAL part334 The Pepsom Group, Inc. MAGNESIUM SULFATE, UNSPECIFIED 1 kg/kg 51621-010_c3a82f58-fa93-42b3-8f94-0102ae8b6c92 51621-010 HUMAN OTC DRUG Gowoonsesang Sun Lotion SPF32 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE 1.77 mL/100mL 51621-011_c16babda-03b6-49f3-bbf6-51aef2ac9181 51621-011 HUMAN OTC DRUG Gowoonsesang Multi Protection SPF30 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.49; 1.84 mL/60mL; mL/60mL 51621-012_ccc18d3b-543c-4ce7-bd81-b232bbe182a1 51621-012 HUMAN OTC DRUG Gowoonsesang Medi UV Block Suncream SPF50 ZINC OXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.49; 2.88 mL/60mL; mL/60mL 51621-013_5e18a04a-04f4-4f0c-bee6-81e3f057b28d 51621-013 HUMAN OTC DRUG Gowoonsesang Hydra Intensive Blemish Balm SPF30 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 3; .3 mL/60mL; mL/60mL 51621-014_c1c76695-3468-49cb-af89-8d2539232904 51621-014 HUMAN OTC DRUG Gowoonsesang Brightening Balm SPF30 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 4.75; 1.18 mL/60mL; mL/60mL 51621-030_fae17c7c-de3a-4f6c-aafb-c7805e201d9f 51621-030 HUMAN OTC DRUG BEYOND YOUNG BLING BLING SPF35 Titanium Dioxide CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 3.6; .4 mL/45mL; mL/45mL 51621-031_fce1446c-ba51-4929-a0cf-bd4cd58685a3 51621-031 HUMAN OTC DRUG DR.G PRIMER BB PROTECTOR SPF38 TITANIUM DIOXIDE CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 4.5; .45 mL/45mL; mL/45mL 51621-032_1b2f2608-d6aa-4d05-af8a-a24d7a1b76c9 51621-032 HUMAN OTC DRUG ACTIFIRM RECOVERY TONER GOWOONSESANG EXPERT GLYCERIN CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. GLYCERIN 28 mL/140mL 51621-033_4e6c98f7-8484-4ee7-bb15-cf6fcfaa0940 51621-033 HUMAN OTC DRUG ACTIFIRM RECOVERY EMULSION GOWOONSESANG EXPERT DIMETHICONE CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. DIMETHICONE 2 mL/100mL 51621-034_a6c48190-b8ed-454e-9e98-3639135238cb 51621-034 HUMAN OTC DRUG ACTIFIRM RECOVERY SERUM GOWOONSESANG EXPERT DIMETHICONE CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. DIMETHICONE 1.2 mL/30mL 51621-035_1949fdea-f68a-42a9-bfdd-03012212aa6c 51621-035 HUMAN OTC DRUG ACTIFIRM RECOVERY GOWOONSESANG EXPERT DIMETHICONE CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. DIMETHICONE .5 mL/50mL 51621-036_0af88431-f722-489f-93b9-f035c5519c44 51621-036 HUMAN OTC DRUG ACTIFIRM RECOVERY EYE GOWOONSESANG EXPERT ALLANTOIN CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. ALLANTOIN .1 mL/20mL 51621-037_315e310a-7694-435f-8b1a-41e5fe045fd9 51621-037 HUMAN OTC DRUG DR.G DEWRINKLE BOOSTER AMPLE BY EGF GLYCERIN CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. DIMETHICONE; GLYCERIN .1; 2 mL/10mL; mL/10mL 51621-038_33d8d8a3-3aa8-43dc-bba6-861f7ce5e0fe 51621-038 HUMAN OTC DRUG DR.G WHITENING BOOSTER AMPLE BY EGF GLYCERIN CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. DIMETHICONE; GLYCERIN .1; 2 mL/10mL; mL/10mL 51621-039_79e4afae-20b0-4fd8-a139-04528c1bcc83 51621-039 HUMAN OTC DRUG DR.G WHITENING FORTIFIER BY EGF GLYCERIN CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. ALLANTOIN; GLYCERIN .15; 6 mL/30mL; mL/30mL 51621-040_fe6a98d6-964a-40e5-b225-b0d11368acd4 51621-040 HUMAN OTC DRUG DR.G DEWRINKLE FORTIFIER BY EGF GLYCERIN CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. ALLANTOIN; GLYCERIN .15; 6 mL/30mL; mL/30mL 51621-041_1e2a7c8e-4daa-4e9d-bb63-336bb11d920f 51621-041 HUMAN OTC DRUG DR.G DEWRINKLE REFORMER BY EGF DIMETHICONE CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. DIMETHICONE .5 mL/50mL 51621-042_0e821163-ac84-4f62-a1f1-9ada36696d20 51621-042 HUMAN OTC DRUG DR.G WHITENING REFORMER BY EGF GLYCERIN CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. DIMETHICONE; GLYCERIN 2; 10 mL/50mL; mL/50mL 51621-043_b577ae60-e13a-4b0f-b541-b5d2c17ebe46 51621-043 HUMAN OTC DRUG GOWOONSESANG EXPERT ACTIFIRM TM RECOVERY SUPER BLEMISH BASE SPF30 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.35; 3.564; .864 mL/45mL; mL/45mL; mL/45mL 51621-044_de1c4927-df74-42d9-923e-7ff52b7c0f7d 51621-044 HUMAN OTC DRUG GOWOONSESANG PERFECT PORE COVER BB SPF 30 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.35; 3.285; .985 mL/45mL; mL/45mL; mL/45mL 51621-045_4ef4522c-3ed3-4f47-9022-5b287c31b8de 51621-045 HUMAN OTC DRUG Aroma A1 Skin SALICYLIC ACID LOTION TOPICAL 20121001 OTC MONOGRAPH FINAL part333D GOWOONSESANG COSMETICS CO., LTD. SALICYLIC ACID .75 mg/150mL 51621-046_0a7a0cf2-6483-470d-9b91-4f5a9f5f6b51 51621-046 HUMAN OTC DRUG Spot Repairing Serum Salicylic Acid CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part333D GOWOONSESANG COSMETICS CO., LTD. SALICYLIC ACID .065 mg/13mL 51621-047_04b096db-c0f5-4eb9-b459-30b0a8a7cdc3 51621-047 HUMAN OTC DRUG Total Active Dual BB SPF50 PLUS PA PLUS PLUS PLUS Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.5; 6.905; 1.96 mg/50mL; mg/50mL; mg/50mL 51621-050_cf886a3c-f914-440b-8c23-7581086623ac 51621-050 HUMAN OTC DRUG Dr.G Daily Safe BB SPF30 PA Plus Plus titanium dioxide and zinc oxide CREAM CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 9.4; .9 mg/100mg; mg/100mg 51621-051_449918bb-e388-479b-ad30-849c2b49d9ff 51621-051 HUMAN OTC DRUG Dr.G Super Light Brightening Balm SPF30 PA PLUS PLUS Titanium dioxide and Zinc oxide CREAM CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 9.7; 1.9 mg/100mg; mg/100mg 51621-052_643d03c6-df61-4aa4-91f5-41e5929caf2f 51621-052 HUMAN OTC DRUG Dr.G Medi UV Ultra Sun SPF 50 Plus PA Plus Plus Plus zinc oxide and titanium dioxide CREAM CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 4; 5 mg/100mg; mg/100mg 51621-053_f9658252-5995-4167-8067-621c40ba0589 51621-053 HUMAN OTC DRUG Dr. G Brightening Up Sun SPF 42 PA Plus Plus Plus zinc oxide and titanium dioxide CREAM CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.9; 4.9 mg/100mg; mg/100mg 51621-054_2c10f682-fd05-4263-95bf-ef8ec8e2d59e 51621-054 HUMAN OTC DRUG Dr. G A Clear Oil Control Sun SPF50 Plus PA Plus Plus Plus titanium dioxide CREAM CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE 4.2 mg/100mg 51621-055_5889dc13-c5b6-4276-9213-93d83384854f 51621-055 HUMAN OTC DRUG Dr. G A Clear Sensi Acne Sun SPF43 PA Plus Plus Plus zinc oxide and titanium dioxide CREAM CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 4; 5 mg/100mg; mg/100mg 51621-056_abd6f62e-b377-4d2b-a773-66454b04c058 51621-056 HUMAN OTC DRUG Dr.G Radiance Dual Essence BB SPF50 Plus PA Plus Plus Plus titanium dioxide and zinc oxide CREAM CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 13.8; 3.9 mg/100mg; mg/100mg 51621-057_e9429e2b-7c7b-45ec-ad43-0c6bf17b4ca1 51621-057 HUMAN OTC DRUG Dr.G Brightening Balm SPF30 PA Plus Plus titanium dioxide and zinc oxide CREAM CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 9.7; 1.9 mg/100mg; mg/100mg 51621-058_03950995-2f55-495c-8aac-c2cb2a4f9759 51621-058 HUMAN OTC DRUG Dr.G Perfect Pore Cover BB SPF30 PA Plus Plus titanium dioxide and zinc oxide CREAM CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 7.9; 1.9 mg/100mg; mg/100mg 51621-059_7fa28835-6f13-4292-8261-343961efead4 51621-059 HUMAN OTC DRUG Dr.G A Clear Foam Cream salicylic acid CREAM CUTANEOUS 20141115 OTC MONOGRAPH FINAL part333D GOWOONSESANG COSMETICS CO., LTD. SALICYLIC ACID .5 mg/100mg 51621-060_fb093c15-2a30-4e67-a984-0aa348679a79 51621-060 HUMAN OTC DRUG Dr.G A Clear Aroma Spot Toner salicylic acid LIQUID CUTANEOUS 20141115 OTC MONOGRAPH FINAL part333D GOWOONSESANG COSMETICS CO., LTD. SALICYLIC ACID .5 mg/100mg 51621-061_e7002718-7072-4132-b43e-33c1356f3591 51621-061 HUMAN OTC DRUG DR.G Moist Ample CC Cushion SPF50 Plus PA Plus Plus Plus Light Beige titanium dioxide and zinc oxide LIQUID CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 9.8; 7.5 mg/100mg; mg/100mg 51621-062_20d376ac-dbc7-4b49-b811-49b30478b046 51621-062 HUMAN OTC DRUG Dr. G Moist Ample CC Cushion SPF 50 Plus PA Plus Plus Plus Natural Beige titanium dioxide and zinc oxide LIQUID CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 9.7; 7.5 mg/100mg; mg/100mg 51621-063_d09e1103-4f3f-44d5-8811-7a139555031e 51621-063 HUMAN OTC DRUG Dr.G Age Defense BB SPF50 Plus PA Plus Plus titanium dioxide and zinc oxide CREAM CUTANEOUS 20141201 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 14.7; 3.9 mg/100mg; mg/100mg 51625-001_85ebeb0a-32e1-4d7e-a628-e6980f8a86e4 51625-001 HUMAN OTC DRUG Scott-Vincent Borba Anti-Fatige 8 Hour Mineral Foundation with Broad Spectrum SPF 29 Zinc Oxide POWDER TOPICAL 20120705 OTC MONOGRAPH NOT FINAL part352 Scott-Vincent Borba ZINC OXIDE 18 g/100g 51625-002_85ebeb0a-32e1-4d7e-a628-e6980f8a86e4 51625-002 HUMAN OTC DRUG Scott-Vincent Borba Anti-Fatige 8 Hour Mineral Foundation with Broad Spectrum SPF 29 Zinc Oxide POWDER TOPICAL 20120705 OTC MONOGRAPH NOT FINAL part352 Scott-Vincent Borba ZINC OXIDE 18 g/100g 51625-003_85ebeb0a-32e1-4d7e-a628-e6980f8a86e4 51625-003 HUMAN OTC DRUG Scott-Vincent Borba Anti-Fatige 8 Hour Mineral Foundation with Broad Spectrum SPF 29 Zinc Oxide POWDER TOPICAL 20120705 OTC MONOGRAPH NOT FINAL part352 Scott-Vincent Borba ZINC OXIDE 18 g/100g 51628-0001_f0314080-e037-459a-855b-78ea05c74f77 51628-0001 HUMAN OTC DRUG Natural Epsom Salt magnesium sulfate POWDER TOPICAL 20141009 OTC MONOGRAPH NOT FINAL part334 My Import USA Inc MAGNESIUM SULFATE 10 g/10g 51628-0002_a0b1de28-b908-4bc7-8efb-157cb593d70e 51628-0002 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse for normal hair PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H My Import USA Inc PYRITHIONE ZINC 20 mg/400mg 51628-0003_f99e2417-3f24-41dc-bc2b-7383b24d677b 51628-0003 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse for sensitive hair PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H My Import USA Inc PYRITHIONE ZINC 20 mg/400mg 51628-3232_228b9c17-cbe7-42a7-b451-6a377aa77dff 51628-3232 HUMAN OTC DRUG Choice Personal Care Vapor Rub Camphor and Eucalyptus Oil and Menthos GEL TOPICAL 20101101 OTC MONOGRAPH FINAL part341 My Import Inc CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 5.4; 1.4; 3 g/g; g/g; g/g 51628-3434_84305cb2-b08d-4c3e-8e63-b88bb57067cf 51628-3434 HUMAN OTC DRUG Choice Personal Care Theraputic Blue Ice Menthol GEL TOPICAL 20100615 OTC MONOGRAPH NOT FINAL part348 My Import Inc MENTHOL 2 g/100g 51628-3535_1ecfc2f8-3fa0-4870-aff5-0c5b37f55f57 51628-3535 HUMAN OTC DRUG Choice Personal Care Petroleum White petroleum JELLY TOPICAL 20101101 OTC MONOGRAPH FINAL part347 My Import Inc PETROLATUM 1 g/g 51628-3636_1ecfc2f8-3fa0-4870-aff5-0c5b37f55f57 51628-3636 HUMAN OTC DRUG Choice Personal Care Baby Fresh Scented Petroleum White petroleum JELLY TOPICAL 20101101 OTC MONOGRAPH FINAL part347 My Import Inc PETROLATUM 1 g/g 51628-3737_1ecfc2f8-3fa0-4870-aff5-0c5b37f55f57 51628-3737 HUMAN OTC DRUG Choice Personal Care Cocoa Butter Scented Petroleum White petroleum JELLY TOPICAL 20101101 OTC MONOGRAPH FINAL part347 My Import Inc PETROLATUM 1 g/g 51630-001_0e235eb8-857f-45d7-82ce-97952329e18d 51630-001 HUMAN OTC DRUG No7 Protect and Perfect Skincare System Day Sunscreen SPF 15 Octinoxate, Avobenzone and Octisalate EMULSION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 Schmid & Son Packaging AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3; 1.25 mL/50mL; mL/50mL; mL/50mL 51630-002_2b280670-c179-43ed-b207-b7835cb3af95 51630-002 HUMAN OTC DRUG No7 Lifting and Firming Skincare System Day Sunscreen SPF 8 Avobenzone, Octinoxate and Octisalate EMULSION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 Schmid & Son Packaging AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3.75; 1 mL/50mL; mL/50mL; mL/50mL 51630-003_0b29bbeb-7dbd-4a41-9bb1-a93635ce06d4 51630-003 HUMAN OTC DRUG No7 Protect and Perfect Day Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20130118 OTC MONOGRAPH NOT FINAL part352 Schmid and Son Packaging AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3; 1.25 g/50g; g/50g; g/50g 51630-004_489b7814-976b-4fb7-9aea-fe47eacf4ad1 51630-004 HUMAN OTC DRUG No7 Lift and Luminate Day Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octocrylene CREAM TOPICAL 20130122 OTC MONOGRAPH NOT FINAL part352 Schmid and Son Packaging AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.5; 2.5; .5 g/50g; g/50g; g/50g 51645-269_020bb570-d57c-4199-b4f5-8bf98ebd7866 51645-269 HUMAN OTC DRUG SINE OFF MAXIMUM STRENGTH ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20100705 OTC MONOGRAPH FINAL part341 Gemini Pharmaceuticals, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 51645-291_a6f1bd15-8e12-476c-a9b3-ebdd8e2b0bdb 51645-291 HUMAN OTC DRUG SINE OFF SINUS/COLD MEDICINE ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20100705 OTC MONOGRAPH FINAL part343 Gemini Pharmaceuticals, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 500; 2; 5 mg/1; mg/1; mg/1 51645-600_d62b9994-c87c-4671-a8bf-f70f117039bc 51645-600 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20120330 OTC MONOGRAPH FINAL part343 Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals ACETAMINOPHEN 325 mg/1 51645-601_2f22f198-2986-43db-a34f-5ab31ff92338 51645-601 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20120330 OTC MONOGRAPH FINAL part343 Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals ACETAMINOPHEN 500 mg/1 51645-602_e934a33e-1123-4b27-a86e-1b0cc9f0f015 51645-602 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20120330 OTC MONOGRAPH FINAL part343 Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals ACETAMINOPHEN 500 mg/1 51645-606_7198c69e-fac0-412a-b19a-225f32ac52b9 51645-606 HUMAN OTC DRUG DOCUSATE SODIUM DOCUSATE SODIUM TABLET, FILM COATED ORAL 20120330 OTC MONOGRAPH NOT FINAL part334 Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals DOCUSATE SODIUM 100 mg/1 51645-703_fda60e8e-d746-4087-99c9-c39c79e93966 51645-703 HUMAN OTC DRUG Plus Pharma Pain Reliever,Fever Reducer 325 mg ACETAMINOPHEN TABLET ORAL 20060327 OTC MONOGRAPH NOT FINAL part343 Gemini Pharmaceuticals, Inc. dba Plus Pharma ACETAMINOPHEN 325 mg/1 51645-705_7121273d-b9b1-47cf-8d44-5ddd2bf61cc9 51645-705 HUMAN OTC DRUG PlusPharma Extra Strength PAIN RELIEVER,FEVER REDUCER 500 mg ACETAMINOPHEN TABLET ORAL 20060327 OTC MONOGRAPH NOT FINAL part343 Gemini Pharmaceuticals, Inc. dba Plus Pharma ACETAMINOPHEN 500 mg/1 51645-706_d916f2ab-5567-4b41-ae3f-0ab409d016f6 51645-706 HUMAN OTC DRUG PlusPharma Extra Strength PAIN RELIEVER,FEVER REDUCER 500 mg Acetaminophen TABLET ORAL 20060327 OTC MONOGRAPH NOT FINAL part343 Gemini Pharmaceuticals, Inc. dba Plus Pharma ACETAMINOPHEN 500 mg/1 51645-709_eaf9aea0-3a5a-475b-a402-86a62a30fc85 51645-709 HUMAN OTC DRUG Plus Pharma Extra Strength Acetaminophen PM Acetaminophen,Diphenhydramine HCl TABLET, FILM COATED ORAL 20060327 OTC MONOGRAPH NOT FINAL part343 Gemini Pharmaceuticals, Inc. dba Plus Pharma ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 51645-711_65ca43ad-80ad-4684-83b9-ace82728da32 51645-711 HUMAN OTC DRUG Childrens Chewable Acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20101203 OTC MONOGRAPH FINAL part343 Gemini Pharmaceuticals, Inc. dba Plus Pharma ACETAMINOPHEN 80 mg/1 51645-716_127d67c5-eb2c-4062-8bc9-99700096cec5 51645-716 HUMAN OTC DRUG Plus Pharma NSAID Aspirin ASPIRIN TABLET ORAL 20060327 OTC MONOGRAPH FINAL part343 Gemini Pharmaceuticals, Inc. dba Plus Pharma ASPIRIN 325 mg/1 51645-717_b4c5bc15-419e-44b3-89e5-ddfc11a9612e 51645-717 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, EXTENDED RELEASE ORAL 20130110 OTC MONOGRAPH FINAL part343 Gemini Pharmaceuticals, Inc. dba Plus Pharmaceuticals ASPIRIN 81 mg/1 51645-735_ebb33931-177a-45d8-a5c9-a261850b3434 51645-735 HUMAN OTC DRUG Plus Pharma Calcium Antacid CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20060327 OTC MONOGRAPH FINAL part331 Gemini Pharmaceuticals, Inc. dba Plus Pharma CALCIUM CARBONATE 500 mg/1 51645-750_ba62a8ba-657c-4ce0-859f-fe75d36d5e4c 51645-750 HUMAN OTC DRUG PlusPHARMA Stool Softener 100 mg DOCUSATE SODIUM TABLET, FILM COATED ORAL 20060327 OTC MONOGRAPH NOT FINAL part334 Gemini Pharmaceuticals, Inc. dba Plus Pharma DOCUSATE SODIUM 100 mg/1 51645-826_3dec4503-1ca1-42b5-b999-f0111aff86b0 51645-826 HUMAN OTC DRUG TELDRIN ALLERGY RELIEF CHLORPHENIRAMINE MALEATE TABLET ORAL 20100705 OTC MONOGRAPH FINAL part341 Gemini Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 51645-850_a44df4a7-2cf8-4677-9802-e47a4f56e467 51645-850 HUMAN OTC DRUG Plus Pharma Senna Plus Standardized Senna Concentrate 8.6 mg and Docusate Sodium 50 mg Each DOCUSATE SODIUM,SENNOSIDES TABLET, FILM COATED ORAL 20060327 OTC MONOGRAPH NOT FINAL part334 Gemini Pharmaceuticals, Inc. dba Plus Pharma DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 51645-851_8a8d1d28-d779-492c-9671-20d94c36a0d1 51645-851 HUMAN OTC DRUG Plus Pharma Senna Standardized Senna Concentrate 8.6 mg Sennosides Each SENNOSIDES TABLET, FILM COATED ORAL 20060327 OTC MONOGRAPH NOT FINAL part334 Gemini Pharmaceuticals, Inc. dba Plus Pharma SENNOSIDES 8.6 mg/1 51645-860_dc06b24f-2ac9-440e-92b4-8e575d2dfcee 51645-860 HUMAN OTC DRUG PlusPHARMA Simethicone TABLET, CHEWABLE ORAL 20060327 OTC MONOGRAPH FINAL part347 Gemini Pharmaceuticals, Inc. dba Plus Pharma DIMETHICONE 80 mg/1 51655-000_8a00251e-c746-4e11-9f5a-4e805c50f406 51655-000 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20140516 ANDA ANDA076268 Northwind Pharmaceuticals DIGOXIN .25 mg/301 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 51655-001_a474a986-17f1-456b-b543-93c12314f147 51655-001 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20140516 ANDA ANDA076268 Northwind Pharmaceuticals DIGOXIN .125 mg/301 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 51655-002_b6948d4a-cf4b-4e3a-918b-d6faef6ac0c7 51655-002 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20140516 ANDA ANDA077316 Northwind Pharmaceuticals CARVEDILOL 12.5 mg/301 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 51655-003_cdec0059-c52f-4f86-8935-ae5da1f1b8c6 51655-003 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride ER Bupropion Hydrochloride TABLET ORAL 20140601 ANDA ANDA078866 Northwind Pharmaceuticals BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 51655-004_f2f0bebd-9c2b-44ec-9355-7241b9e8d965 51655-004 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20140820 ANDA ANDA065470 Northwind Pharmaceuticals, LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 51655-009_7e1779df-a430-4654-80fc-95cf391c279d 51655-009 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20140507 ANDA ANDA076509 Northwind Pharmaceuticals FENOFIBRATE 160 mg/301 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 51655-010_fcef12aa-ba34-4a2c-abdd-9447cc18f3ac 51655-010 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20140520 NDA AUTHORIZED GENERIC NDA021656 Northwind Pharmaceuticals FENOFIBRATE 145 mg/301 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 51655-011_8eee627c-3fd8-415e-ab52-61eb50b9b091 51655-011 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20140601 ANDA ANDA062935 Northwind Pharmaceuticals PENICILLIN V POTASSIUM 500 mg/1 51655-012_7e4447b7-7fac-4f5b-9cda-1f36d892dd2e 51655-012 HUMAN PRESCRIPTION DRUG Dexamethsone Dexamethasone TABLET ORAL 20140811 ANDA ANDA084612 Northwind Pharmaceuticals, LLC DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51655-013_eb5d4ec9-b37e-4bf8-906d-381d3f09cb7f 51655-013 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20141104 ANDA ANDA075828 Northwind Pharmaceuticals, LLC LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51655-022_510cd356-71c4-4dfa-ae65-6517027e936e 51655-022 HUMAN PRESCRIPTION DRUG OMEPRAZOLE DR OMEPRAZOLE DR CAPSULE, DELAYED RELEASE ORAL 20141027 ANDA ANDA076048 Northwind Pharmaceuticals, LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 51655-025_9dd1bb2d-9158-487f-a1c7-f82ef43d6029 51655-025 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20140617 ANDA ANDA062713 Northwind Pharmaceuticals CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 51655-026_18dbd24a-dd4b-4e2a-be9c-02d48078122c 51655-026 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin TABLET ORAL 20140718 ANDA ANDA065253 Northwind Pharmaceuticals, LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 51655-027_0f7228b0-773b-4355-b439-b6b6f5bd1659 51655-027 HUMAN PRESCRIPTION DRUG Loratadine Loratadine TABLET ORAL 20141027 ANDA ANDA076134 Northwind Pharmaceuticals, LLC LORATADINE 10 mg/1 51655-028_e84ab16b-5c05-4f83-aad8-561526d4fb9d 51655-028 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20141106 ANDA ANDA090836 Northwind Pharmaceuticals, LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 51655-035_d5322ad0-d35e-4c10-b99d-59e297b56133 51655-035 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20141028 ANDA ANDA078558 Northwind Pharmaceuticals, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51655-049_fe6941d6-a3aa-4dcc-a6d3-865fd95f13b0 51655-049 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20140520 ANDA ANDA078558 Northwind Pharmaceuticals IBUPROFEN 400 mg/301 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51655-050_a11a1b89-4de9-4a4d-a77c-7cbab4c361c8 51655-050 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20140814 ANDA ANDA090796 Northwind Pharmaceuticals, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51655-051_07f45390-2f16-40f2-8ec4-b9960d33f0c6 51655-051 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20140601 ANDA ANDA078558 Northwind Pharmaceuticals IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51655-053_71eaa8fe-12db-4b68-b8a1-7dd54a323b48 51655-053 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amolodipine Besylate TABLET ORAL 20140921 ANDA ANDA077955 Northwind Pharmaceuticals, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 51655-054_da8046b5-5bab-4c31-b660-7eb19c19688e 51655-054 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140923 ANDA ANDA077955 Northwind Pharmaceuticals, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 51655-055_3fac1172-9965-4419-bbff-93f4a585f8af 51655-055 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20141015 ANDA ANDA040656 Northwind Pharmaceuticals, LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 51655-067_f3da3837-01b1-49df-8a12-82587391d24a 51655-067 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride Benazepril hydrochloride TABLET, FILM COATED ORAL 20140530 ANDA ANDA076118 Northwind Pharmaceuticals BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 51655-071_35e36f3c-fc38-4dfd-a4ef-f7ad3879fc99 51655-071 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20141112 ANDA ANDA077751 Northwind Pharmaceuticals, LLC PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51655-072_3f32e8dd-e412-494b-8d3e-d793070402d5 51655-072 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20140710 ANDA ANDA077751 Northwind Pharmaceuticals, LLC PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51655-073_aeffdfbb-5721-46e1-829f-fd545b9b5864 51655-073 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20141112 ANDA ANDA076056 Northwind Pharmaceuticals, LLC PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51655-078_db5d3eb6-ca9e-4562-bee4-ca54e2c2abc0 51655-078 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET ORAL 20140915 ANDA ANDA040804 Northwind Pharmaceuticals, LLC HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 51655-085_92aa2695-ebb7-4e26-8ef1-0c3fda2b530a 51655-085 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride TABLET ORAL 20140601 ANDA ANDA091179 Northwind Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51655-089_738fba50-2fba-446c-af05-5eee1dd79487 51655-089 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20141008 ANDA ANDA021210 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51655-091_e561a5af-c541-4ef0-b027-9d1af884ac72 51655-091 HUMAN PRESCRIPTION DRUG Levothyroxine Levothyroxine TABLET ORAL 20140710 NDA NDA021342 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51655-092_6ef21e8d-473a-4a1c-a9a2-ecc0e7dbc0ce 51655-092 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20140731 NDA NDA021210 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51655-094_ca663e1b-16e0-4ed8-a281-ea3baedf8acd 51655-094 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20141021 NDA NDA021210 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51655-096_daf3e067-b54c-463a-ac6b-4d0c316cf42d 51655-096 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET ORAL 20140428 ANDA ANDA040268 Northwind Pharmaceuticals PROCHLORPERAZINE MALEATE 5 mg/61 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51655-099_b4cd2005-abc9-46fd-9209-df6b57b8f730 51655-099 HUMAN PRESCRIPTION DRUG acyclovir Acyclovir TABLET ORAL 20140514 ANDA ANDA075382 Northwind Pharmaceuticals ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 51655-100_014435f6-f88d-4970-8500-7b0a02558df0 51655-100 HUMAN PRESCRIPTION DRUG fluoxetine hydrochloride fluoxetine hydrochloride CAPSULE ORAL 20140520 ANDA ANDA078619 Northwind Pharmaceuticals FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51655-101_1371cbfe-0382-47cc-b787-927b6c328df0 51655-101 HUMAN PRESCRIPTION DRUG fluoxetine hydrochloride fluoxetine hydrochloride CAPSULE ORAL 20141103 ANDA ANDA076001 Northwind Pharmaceuticals, LLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51655-102_aad50742-6e1c-433d-9d92-01d8385d14e0 51655-102 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20140825 ANDA ANDA075511 Northwind Pharmaceuticals,LLC FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 51655-107_dbceffa8-8d86-4e96-8657-cb5ebdb22b63 51655-107 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20140724 ANDA ANDA040659 Northwind Pharmaceuticals, LLC MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 51655-111_57112ce4-1d1f-43ba-b1f4-adbbab735a1d 51655-111 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20140515 ANDA ANDA076817 Northwind Pharmaceuticals SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 51655-112_cb8e448c-9616-462d-a412-94af74c2ad17 51655-112 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20140303 ANDA ANDA040596 Northwind Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51655-114_0b841234-a6a0-48a8-a098-f4e9c981a332 51655-114 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride TABLET ORAL 20140520 ANDA ANDA040596 Northwind Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/301 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51655-118_b8fa8de7-dac7-4d6c-a12c-96359843471f 51655-118 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20140601 ANDA ANDA076639 Northwind Pharmaceuticals CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 51655-125_4afc9b83-70f5-4d70-a7e2-6fb333dd7ae6 51655-125 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20140620 ANDA ANDA065229 Northwind Pharmaceuticals CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 51655-126_0ad79730-c47e-49b0-b9f2-c1766b19c741 51655-126 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20140821 ANDA ANDA040807 Northwind Pharmaceuticals, LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51655-127_21938319-b511-49a7-a4a0-39e9b649f589 51655-127 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 20140914 ANDA ANDA079237 Northwind Pharmaceuticals, LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51655-131_6c9ee14a-df87-4ebb-afc8-f717529ed4f7 51655-131 HUMAN PRESCRIPTION DRUG SILDENAFIL SILDENAFIL TABLET, FILM COATED ORAL 20141106 ANDA ANDA091479 Northwind Pharmaceuticals, LLC SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 51655-141_389f19d2-25dd-40aa-828e-7e0780110109 51655-141 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20140923 ANDA ANDA086988 Northwind Pharmaceuticals, LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 51655-142_b27b252d-24b6-46c9-aedb-67f1630bb3c9 51655-142 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20141023 ANDA ANDA077836 Northwind Pharmaceuticals, LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 51655-151_2ba31b0a-87b0-4949-871d-d682f12ba8cd 51655-151 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20140321 ANDA ANDA076765 Northwind Pharmaceuticals ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51655-154_7f787179-6486-488b-ad2d-dcf58812a854 51655-154 HUMAN PRESCRIPTION DRUG Phenazopyridine hydrochloride Phenazopyridine hydrochloride TABLET ORAL 20140601 UNAPPROVED DRUG OTHER Northwind Pharmaceuticals PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 51655-155_873411d8-d58b-40cb-a394-98fc4adde2eb 51655-155 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20140724 UNAPPROVED DRUG OTHER Northwind Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 51655-156_74ff0527-bbf9-4288-81fd-abb7eddd075c 51655-156 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20141106 ANDA ANDA065271 Northwind Pharmaceuticals, LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 51655-157_7a891dd1-ed56-4f00-89fb-2d6be99252c9 51655-157 HUMAN PRESCRIPTION DRUG Amoxicillan Amoxicillan CAPSULE ORAL 20140601 ANDA ANDA062881 Northwind Pharmaceuticals AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 51655-158_c07e72b4-3106-4cd3-acd8-365121c5e687 51655-158 HUMAN PRESCRIPTION DRUG Amoxicillan and clavulanate potassium Amoxicillan and clavulanate potassium TABLET, FILM COATED ORAL 20140718 ANDA ANDA091569 Northwind Pharmaceuticals, LLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 51655-159_9c806097-3e17-4611-b18d-ec76528f20eb 51655-159 HUMAN PRESCRIPTION DRUG Amoxicillan Amoxicillan TABLET ORAL 20140718 ANDA ANDA062058 Northwind Pharmaceuticals,LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 51655-160_d8c1bbab-8384-4098-92f5-d3446aa8f541 51655-160 HUMAN PRESCRIPTION DRUG AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED ORAL 20140718 ANDA ANDA065096 Northwind Pharmaceuticals. LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 51655-162_69c4836e-6de5-4525-8689-b81c3fd807cd 51655-162 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20140212 ANDA ANDA203399 Northwind Pharmaceuticals METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 51655-163_87d1b2d2-6d3e-4828-a956-12f863fd62a8 51655-163 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20140401 NDA NDA013217 Northwind Pharmaceuticals METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 51655-165_76489519-031d-4c8e-a423-a8484eab5730 51655-165 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET ORAL 20141029 ANDA ANDA075074 Northwind Pharmaceuticals, LLC ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51655-166_4c35c142-b89f-4536-85bd-ec8c006ab53f 51655-166 HUMAN PRESCRIPTION DRUG ETODOLAC ETODOLAC CAPSULE ORAL 20141113 ANDA ANDA075419 Northwind Pharmaceuticals, LLC ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51655-170_9151a121-dc59-4525-83aa-81a5aa2eaca6 51655-170 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20140715 ANDA ANDA074754 Northwind Pharmaceuticals, LLC KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51655-184_05a17f94-218e-49aa-9d33-6a0d832f40b2 51655-184 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20140915 ANDA ANDA062031 Northwind Pharmaceuticals DOXYCYCLINE HYCLATE 100 mg/1 51655-185_39dcdd81-7699-4582-8a85-f763d7d73e18 51655-185 HUMAN PRESCRIPTION DRUG Ultram TRAMADOL HCL TABLET, COATED ORAL 20140213 ANDA ANDA076003 NORTHWIND PHARMACEUTICALS TRAMADOL HYDROCHLORIDE 50 mg/201 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 51655-186_ec7aaef1-b7f4-4b7c-962e-df2bbc773945 51655-186 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20140506 ANDA ANDA076899 Northwind Pharmaceuticals SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/281; mg/281 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 51655-187_a40c09d8-61dd-4cd3-8f7d-26c2150664e4 51655-187 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20140506 ANDA ANDA071017 Northwind Pharmaceuticals SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1411; mg/1411 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 51655-189_49502689-685c-4fd3-b1a4-3d1f76d61581 51655-189 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE TABLET ORAL 20140917 ANDA ANDA070033 Northwind Pharmaceuticals, LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 51655-214_6975ec56-9942-452c-8a09-d6eea291c97d 51655-214 HUMAN PRESCRIPTION DRUG CEFDINIR CEFDINIR CAPSULE ORAL 20140917 ANDA ANDA065368 Northwind Pharmaceuticals, LLC CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 51655-232_7fa0a064-8604-41e1-af38-facea0c9c0ab 51655-232 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20140730 ANDA ANDA077321 Northwind Pharmaceuticals, LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51655-250_d5f56722-7f87-47c0-a473-154d80dd9a51 51655-250 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20140303 ANDA ANDA200839 Northwind Pharmaceuticals LEVOFLOXACIN 500 mg/1 51655-279_978f67f2-e58a-4843-b1a5-892b60a0a1f5 51655-279 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20141209 ANDA ANDA075483 Northwind Pharmaceuticals, LLC ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 51655-290_64f1daf6-af49-4087-a874-974fed3ecb79 51655-290 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE LEVOTHYROXINE TABLET ORAL 20140914 NDA AUTHORIZED GENERIC NDA021210 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51655-293_dcf2178c-cef8-4123-962d-e972189b3dbe 51655-293 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20141103 NDA NDA021210 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51655-294_05bb67cd-8411-485c-a745-6adb17662b7f 51655-294 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20141125 NDA NDA021210 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51655-300_09c1343a-0cdb-4693-a3b4-9d8c3a1c58b0 51655-300 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20141022 ANDA ANDA203834 Northwind Pharmaceuticals, LLC ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 51655-301_9dccd222-84fc-4190-b5fa-2f100d999e2e 51655-301 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140507 ANDA ANDA076549 Northwind Pharmaceuticals RAMIPRIL 10 mg/301 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51655-318_43f30617-de6a-47e3-a715-e41f45b20d14 51655-318 HUMAN PRESCRIPTION DRUG Propranolol Hyrochloride Propranolol Hydrochloride TABLET ORAL 20140515 ANDA ANDA070213 Northwind Pharmaceuticals PROPRANOLOL HYDROCHLORIDE 10 mg/301 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51655-320_6d2cbb51-7147-4af8-8c13-321cd675afc1 51655-320 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140429 ANDA ANDA088832 Northwind Pharmaceuticals PREDNISONE 20 mg/201 51655-320_abd6c038-2c14-4d9a-88a4-b823a8874b28 51655-320 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140501 ANDA ANDA088832 Northwind Pharmaceuticals PREDNISONE 20 mg/201 51655-352_035c8fa3-716d-4d70-a880-023fc4aa9372 51655-352 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20140711 ANDA ANDA077670 Northwind Pharmaceuticals, LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51655-362_96a7c367-d1e4-421a-9cb4-6b40570b0f92 51655-362 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20140924 ANDA ANDA070975 Northwind Pharmaceuticals, LLC CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 51655-376_f81393a1-0bb9-47de-bab6-0c06c0daab8d 51655-376 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20140601 ANDA ANDA040755 Northwind Pharmaceuticals CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 51655-391_691af6ba-bce1-4977-b03b-3180ca53d8e1 51655-391 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20140714 ANDA ANDA080937 Northwind Pharmaceuticals, LLC ISONIAZID 300 mg/1 Antimycobacterial [EPC] 51655-400_3b21ffaa-d097-438d-b14b-f403d9f97608 51655-400 HUMAN PRESCRIPTION DRUG Ondansetron HCL Ondansetron HCL TABLET, COATED ORAL 20140317 ANDA ANDA077851 Northwind Pharmaceuticals ONDANSETRON HYDROCHLORIDE 4 mg/31 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 51655-401_fb21d11f-0e65-484e-93a5-111b850bf67c 51655-401 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20140520 ANDA ANDA077321 Northwind Pharmaceuticals LISINOPRIL 10 mg/301 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51655-402_765927a0-c165-4e9d-ab40-051d41b03a9d 51655-402 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20141117 ANDA ANDA075994 Northwind Pharmaceuticals, LLC LISINOPRIL 10 1/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51655-408_704ea6a9-118f-497c-b9dc-435ce1142f90 51655-408 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20141121 ANDA ANDA075994 Northwind Pharmaceuticals, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51655-410_7ca135fd-320e-4019-b572-0319d6372205 51655-410 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140428 ANDA ANDA085162 Northwind Pharmaceuticals PREDNISONE 10 mg/201 51655-412_c8caabb2-8abb-4614-8258-1ab6367fd789 51655-412 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20140729 ANDA ANDA077912 Northwind Pharmaceuticals, LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51655-413_0dfdb771-023a-4426-bfc7-49a5e896232f 51655-413 HUMAN PRESCRIPTION DRUG Lisinopril and HCTZ Lisinopril and Hydrochlorothiazide TABLET ORAL 20140710 ANDA ANDA077912 Northwind Pharmaceuticals, LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 51655-414_76748dbe-7cfc-4905-8075-aad9a062aacb 51655-414 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20140825 ANDA ANDA076194 Northwind Pharmaceuticals, LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51655-425_82dfc095-30e3-441a-a9b6-5276a049f5a6 51655-425 HUMAN PRESCRIPTION DRUG Clemastine Fumarate Clemastine Fumarate TABLET ORAL 20140428 ANDA ANDA073283 Northwind Pharmaceuticals, LLC CLEMASTINE FUMARATE 2.68 mg/1 51655-439_96c19934-b215-4c4a-baa7-a3ac8a3285f5 51655-439 HUMAN PRESCRIPTION DRUG Cyclobenzaprine hydrochloride Cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20140516 ANDA ANDA073144 Northwind Pharmaceuticals CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/301 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 51655-440_f96a93b8-80e0-456a-90b3-ff49532e399d 51655-440 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20141124 ANDA ANDA071611 Northwind Pharmaceuticals, LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 51655-500_abee16aa-a278-4e4e-bbce-3b2f0599ba2f 51655-500 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed Release Pantoprazole Sodium Delayed Release TABLET, DELAYED RELEASE ORAL 20140321 ANDA ANDA090970 Northwind Pharmaceuticals PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 51655-501_9fe62b0e-e0ec-4b5b-8431-d211b60a85c3 51655-501 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium DR Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140716 ANDA ANDA077056 Northwind Pharmaceuticals, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 51655-530_0af35e27-d4d7-4fed-9a51-8bd35bfe839e 51655-530 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20140601 ANDA ANDA065442 Northwind Pharmaceuticals CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 51655-535_0b5dcd1d-6f04-4b1b-b221-e1e0c409ee96 51655-535 HUMAN PRESCRIPTION DRUG Metoprolol Tartate Metoprolol Tartate TABLET ORAL 20140602 ANDA ANDA074644 Northwind Pharmaceuticals METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51655-536_126aefce-4386-49d9-9a2c-28e7c26441ae 51655-536 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20140919 ANDA ANDA074644 Northwind Pharmaceuticals, LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51655-547_507afe22-33ab-4fc5-95c7-74dfd5dda6cd 51655-547 HUMAN PRESCRIPTION DRUG Loperamide hydrochloride Loperamide hydrochloride CAPSULE ORAL 20141022 ANDA ANDA073192 Northwind Pharmaceuticals, LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 51655-550_fd289a35-1096-43a6-88fe-5bc685961eaa 51655-550 HUMAN PRESCRIPTION DRUG Metformin hydrochloride ER Metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20140423 ANDA ANDA076706 Northwind Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 51655-560_92c61dfb-ce98-4cb1-bd75-a80f17e3915e 51655-560 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20140408 ANDA ANDA090564 Northwind Pharmaceuticals METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 51655-561_509a8606-c35e-4111-b9b4-aee57da12cb4 51655-561 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20140430 ANDA ANDA090564 Northwind Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 51655-562_c7ae5667-dab8-42b6-9224-86f284b16536 51655-562 HUMAN PRESCRIPTION DRUG Metformin hydrochloride ER Metformin hydrochloride ER TABLET ORAL 20140601 ANDA ANDA076869 Northwind Pharmaceuticals METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 51655-577_34a7ad68-12c2-4561-a4a1-3551da5bba1c 51655-577 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20140402 ANDA ANDA077927 Northwind Pharmaceuticals MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51655-580_29d4a7fc-d528-41c5-b180-3bef81100879 51655-580 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140507 ANDA ANDA076862 Northwind Pharmaceuticals METOPROLOL SUCCINATE 50 mg/301 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51655-581_43621eb3-651a-4a60-94d1-c422db1d2c6e 51655-581 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140506 ANDA ANDA077118 Northwind Pharmaceuticals METOPROLOL SUCCINATE 25 mg/301 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51655-584_a3761914-c254-43bb-9718-7a6b4245e01a 51655-584 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20140912 ANDA ANDA074644 Northwind Pharmaceuticals, LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51655-585_6c70ed2b-67cd-4dd5-a5dc-524c4d95475f 51655-585 HUMAN PRESCRIPTION DRUG Potassium Chloride ER Potassium Chloride TABLET ORAL 20141022 ANDA ANDA076368 Northwind Pharmaceuticals, LLC POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 51655-588_0e68f892-a948-44db-9fca-cb3f798fdde0 51655-588 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride TABLET ORAL 20140519 ANDA ANDA040596 Northwind Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/301 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 51655-600_87fa25f6-1665-4327-b5e6-127805754cda 51655-600 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20141028 ANDA ANDA091083 Northwind Pharmaceuticals, LLC NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51655-609_fdf61229-a509-49b2-803d-d6d7ad71f45b 51655-609 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141106 ANDA ANDA077627 Northwind Pharmaceuticals, LLC TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51655-610_c9a109ab-1c3d-46f0-ba6b-b9c8fcd21d1e 51655-610 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20140425 ANDA ANDA076477 Northwind Pharmaceuticals ATORVASTATIN CALCIUM 10 mg/301 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51655-611_1359b74c-ac4a-4f16-83e0-36c8529a53a2 51655-611 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin CAPSULE ORAL 20140718 NDA NDA020064 Northwind Pharmaceuticals, LLC NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 51655-624_a4457b00-0430-490e-9e7e-861fa361f826 51655-624 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140714 ANDA ANDA074661 Northwind Pharmaceuticals, LLC NAPROXEN SODIUM 220 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51655-626_62eb64c4-5b16-43e2-b5b9-8ef14162f1bb 51655-626 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20140528 ANDA ANDA078250 Northwind Pharmaceuticals NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51655-627_1aadd4c5-f8f9-4b97-825f-ab2855a611a0 51655-627 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen TABLET ORAL 20140807 ANDA ANDA078432 Northwind Pharmaceuticals, LLC NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51655-628_bf547f77-f9d8-475d-8bf5-4ec40b616b0f 51655-628 HUMAN PRESCRIPTION DRUG Naproxen Delayed Release Naproxen Delayed Release TABLET, DELAYED RELEASE ORAL 20140516 ANDA ANDA091432 Northwind Pharmaceuticals NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51655-630_3a02772e-2e3b-4a93-ac78-59e5a45e4bdb 51655-630 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20140407 ANDA ANDA071251 Northwind Pharmaceuticals HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51655-634_ae73e6db-4fa3-459c-8b14-11d4404a183c 51655-634 HUMAN PRESCRIPTION DRUG TRAZODONE TRAZODONE TABLET ORAL 20141201 ANDA ANDA071523 Northwind Pharmaceuticals, LLC TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 51655-637_50844cde-b5be-487d-9ac2-145c82ca000c 51655-637 HUMAN PRESCRIPTION DRUG Armour thyroid Armour thyroid TABLET ORAL 20141107 UNAPPROVED DRUG OTHER Northwind Pharmaceuticals, LLC THYROID, PORCINE 60 mg/1 51655-638_29d3764c-c67b-4505-8f2d-c4949427d1f3 51655-638 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20141107 ANDA ANDA090568 Northwind Pharmaceuticals, LLC ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 51655-640_134d5370-36cc-4d6e-96ab-e2cff0247a26 51655-640 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20140403 ANDA ANDA076477 Northwind Pharmaceuticals ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51655-641_868fd6e1-2f35-441c-8a23-4d215a486c54 51655-641 HUMAN PRESCRIPTION DRUG liothyronine sodium liothyronine sodium TABLET ORAL 20141112 ANDA ANDA200295 Northwind Pharmaceuticals, LLC LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 51655-650_e9edf98f-0e55-4c3e-b82c-343ddad744d9 51655-650 HUMAN PRESCRIPTION DRUG atorvastatin calcium atorvastatin calcium TABLET, FILM COATED ORAL 20141008 ANDA ANDA091624 Northwind Pharmaceuticals, LLC ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51655-651_8746302c-baff-4711-ba1c-ab29a41d9bf8 51655-651 HUMAN PRESCRIPTION DRUG VALSARTAN VALSARTAN TABLET, FILM COATED ORAL 20141113 ANDA ANDA077492 Northwind Pharmaceuticals, LLC VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 51655-652_f1f70579-c064-459a-a886-86a0c0704e6e 51655-652 HUMAN PRESCRIPTION DRUG VALSARTAN VALSARTAN TABLET, FILM COATED ORAL 20141113 ANDA ANDA077492 Northwind Pharmaceuticals, LLC VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 51655-670_7bdada38-7f1e-4e26-9585-195d1bfb1a57 51655-670 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET ORAL 20140403 ANDA ANDA077032 Northwind Pharmaceuticals CITALOPRAM HYDROBROMIDE 40 mg/301 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51655-681_ed1c2498-b8dd-4708-b009-0c928f534f53 51655-681 HUMAN PRESCRIPTION DRUG RANITIDINE ranitidine hydrochloride TABLET ORAL 20140915 ANDA ANDA077824 Northwind Pharmaceuticals, LLC RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 51655-685_ad0b72df-bd8e-44ed-bf7d-9889e29af44e 51655-685 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140826 ANDA ANDA078250 Northwind Pharmaceuticals, LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51655-749_cd99058f-0a08-4ac8-8caf-4327c99797c1 51655-749 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20140903 NDA NDA021342 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 51655-769_aa26589d-27a5-4bc2-a938-c4807c772ba4 51655-769 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE TABLET ORAL 20141208 ANDA ANDA040627 Northwind Pharmaceuticals, LLC BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 51655-770_dcb350d5-ee84-40ae-ba41-c4af0167ba77 51655-770 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20140725 ANDA ANDA040749 Northwind Pharmaceuticals, LLC BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 51655-802_cea4b272-8e61-452d-9ea3-ceff10a203dd 51655-802 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE Codeine Phosphate and APAP TABLET ORAL 20140718 ANDA ANDA040779 Northwind Pharmaceuticals, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 51655-822_795c87fe-3c10-4d82-abdc-2a564f12b29d 51655-822 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140601 ANDA ANDA072927 Northwind Pharmaceuticals LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51655-838_8d71b3e9-4182-4e3a-b870-01a60d75c18d 51655-838 HUMAN PRESCRIPTION DRUG SPIRONOLACTONE SPIRONOLACTONE TABLET, FILM COATED ORAL 20140915 ANDA ANDA040353 Northwind Pharmaceuticals, LLC SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 51655-865_37be8bf7-3b24-48ac-a562-9021bd622320 51655-865 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20140601 ANDA ANDA074569 Northwind Pharmaceuticals CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 51655-875_f34fbc55-732a-4573-a843-33c0f325571b 51655-875 HUMAN PRESCRIPTION DRUG Phentermine hydrochloride Phentermine hydrochloride TABLET ORAL 20140515 ANDA ANDA040526 Northwind Pharmaceuticals PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 51655-876_d1d6b361-ba56-4c9d-875b-c4fa75323ccf 51655-876 HUMAN PRESCRIPTION DRUG Phentermine hydrochloride Phentermine hydrochloride TABLET ORAL 20140601 ANDA ANDA040377 Northwind Pharmaceuticals PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 51655-877_04e78751-69ff-4966-9af2-5ac4f21837fa 51655-877 HUMAN PRESCRIPTION DRUG Phentermine hydrochloride Phentermine hydrochloride TABLET ORAL 20140601 ANDA ANDA040555 Northwind Pharmaceuticals PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 51655-880_79cc2478-50d8-4961-beb1-1f2bcbec5d3d 51655-880 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20140428 ANDA ANDA020702 Northwind Pharmaceuticals ATORVASTATIN CALCIUM 80 mg/301 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51655-900_e7513186-4781-43d2-8cb9-c217ca16047e 51655-900 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen Hydrocodone Bitartate and Acetaminophen TABLET ORAL 20140601 ANDA ANDA090118 Northwind Pharmaceuticals ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 51655-920_0118d420-2511-4801-baf4-b52a69869fbf 51655-920 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20140311 ANDA ANDA076477 Northwind Pharmaceuticals ATORVASTATIN CALCIUM 20 mg/301 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 51655-926_1937395b-5f4b-4e04-ae88-d60909220cf1 51655-926 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20140624 ANDA ANDA077877 Northwind Pharmaceuticals, LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51655-950_67c7eee4-8622-489f-8488-452fc94b1273 51655-950 HUMAN PRESCRIPTION DRUG Valsartan HCTZ Valsartan HCTZ TABLET ORAL 20140506 ANDA ANDA091519 Northwind Pharmaceuticals HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/301; mg/301 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51655-951_8aecdef1-5dbc-42d8-adfb-aa649dfd7928 51655-951 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET ORAL 20140506 ANDA ANDA202519 Northwind Pharmaceuticals HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/301; mg/301 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51655-955_acafa40e-1f06-427b-91e6-eddc3caf162a 51655-955 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20140506 ANDA ANDA090370 Northwind Pharmaceuticals VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 51655-956_6f42a283-b311-48d3-b2f3-cb0b45fdaabc 51655-956 HUMAN PRESCRIPTION DRUG Verapamil hydrochloride Verapamil hydrochloride TABLET, EXTENDED RELEASE ORAL 20140527 ANDA ANDA078906 Northwind Pharmaceuticals VERAPAMIL HYDROCHLORIDE 240 mg/301 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 51655-964_fec9fba3-bdb3-4b61-a280-cd72ebb7fe87 51655-964 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20140617 ANDA ANDA065061 Northwind Pharmaceuticals CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 51655-979_49f0a12e-3c5b-4706-a247-f35708794fa6 51655-979 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20140527 ANDA ANDA077670 Northwind Pharmaceuticals SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51660-035_9b776f8c-8119-4443-a16b-2ec5c0f2eb96 51660-035 HUMAN OTC DRUG Famotidine - Acid Controller Famotidine TABLET, FILM COATED ORAL 20100625 ANDA ANDA090283 Ohm Laboratories Inc. FAMOTIDINE 10 mg/1 51660-036_9b776f8c-8119-4443-a16b-2ec5c0f2eb96 51660-036 HUMAN OTC DRUG Famotidine - Acid Controller Famotidine TABLET, FILM COATED ORAL 20100723 ANDA ANDA090283 Ohm Laboratories Inc. FAMOTIDINE 20 mg/1 51660-123_5e3d20c4-188a-4253-a3c6-04ab430861b0 51660-123 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Ohm Laboratories Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 51660-127_cbe85544-dbbb-421c-ae7d-8d464f7a8f20 51660-127 HUMAN PRESCRIPTION DRUG NORLYROC norethindrone TABLET, FILM COATED ORAL 20140415 ANDA ANDA202260 Ohm Laboratories Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 51660-140_5bf4a6c0-912f-4f03-adc5-dbe71d4425c2 51660-140 HUMAN PRESCRIPTION DRUG VALSARTAN VALSARTAN TABLET, FILM COATED ORAL 20140707 ANDA ANDA077492 Ohm Laboratories Inc. VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 51660-141_5bf4a6c0-912f-4f03-adc5-dbe71d4425c2 51660-141 HUMAN PRESCRIPTION DRUG VALSARTAN VALSARTAN TABLET, FILM COATED ORAL 20140707 ANDA ANDA077492 Ohm Laboratories Inc. VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 51660-142_5bf4a6c0-912f-4f03-adc5-dbe71d4425c2 51660-142 HUMAN PRESCRIPTION DRUG VALSARTAN VALSARTAN TABLET, FILM COATED ORAL 20140707 ANDA ANDA077492 Ohm Laboratories Inc. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 51660-143_5bf4a6c0-912f-4f03-adc5-dbe71d4425c2 51660-143 HUMAN PRESCRIPTION DRUG VALSARTAN VALSARTAN TABLET, FILM COATED ORAL 20140707 ANDA ANDA077492 Ohm Laboratories Inc. VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 51660-204_4e98dd9f-4ab9-4d95-95b0-799ce217da70 51660-204 HUMAN OTC DRUG Pseudoephedrine hydrochloride Pseudoephedrine hydrochloride TABLET, FILM COATED ORAL 20060428 ANDA ANDA077442 Ohm Laboratories Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 51660-209_79cfee1c-0ae1-40dd-92d8-cb55dff96545 51660-209 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20090623 ANDA ANDA076134 Ohm Laboratories Inc. LORATADINE 10 mg/1 51660-296_9a11ba29-50ff-41ae-9d56-9f1fe98ccedd 51660-296 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20090107 ANDA ANDA040766 Ohm Laboratories Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 51660-333_0f5196bb-d04d-42f1-865a-9aea8c7194ea 51660-333 HUMAN OTC DRUG Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Ohm Laboratories Inc. ACETAMINOPHEN 650 mg/1 51660-336_5e697698-a455-4ba7-a55b-4191f45c17d6 51660-336 HUMAN OTC DRUG Ohm 8 Hour Pain Reliever/Fever Reducer Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Ohm Laboratories Inc. ACETAMINOPHEN 650 mg/1 51660-340_94c05dc3-be35-4ff8-b57e-71fba081b91a 51660-340 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, EXTENDED RELEASE ORAL 20121221 ANDA ANDA078569 Ohm Laboratories Inc. ACETAMINOPHEN 650 mg/1 51660-351_eb22d034-54f4-4d9f-8e07-355631de0b24 51660-351 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20110628 ANDA ANDA200536 Ohm Laboratories Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 51660-352_1a199803-a059-40ce-8a16-f43cca12e38f 51660-352 HUMAN OTC DRUG Acid Reducer Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20120710 ANDA ANDA201745 Ohm Laboratories Inc. RANITIDINE HYDROCHLORIDE 75 mg/1 51660-423_18558918-4057-4389-b18d-0b3e73ab456d 51660-423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine hydrochloride ibuprofen and pseudoephedrine hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Ohm Laboratories Inc. IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 51660-488_81825fb6-dfd8-4124-8025-8f67c37185be 51660-488 HUMAN OTC DRUG Loratadine and Pseudoephedrine loratadine and pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Ohm Laboratories Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 51660-490_06452540-d883-433e-b0c5-fe2f201bc986 51660-490 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Ohm Laboratories Inc. IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 51660-491_bbe83464-a582-469f-8fac-f98e804d96fe 51660-491 HUMAN OTC DRUG Loratadine and Pseudoephedrine loratadine and pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Ohm Laboratories Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 51660-492_f398ceab-e3d2-421d-813e-b66369f65472 51660-492 HUMAN OTC DRUG Pseudoephedrine hydrochloride pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Ohm Laboratories Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 51660-493_cb7fb0d3-adf6-4c14-ac61-103dc869ebf2 51660-493 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine hydrochloride ibuprofen and pseudoephedrine hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Ohm Laboratories Inc. IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 51660-526_c6fde498-897c-46ae-ae7e-699c89e29ac0 51660-526 HUMAN OTC DRUG Loratadine Allergy Relief Loratadine TABLET ORAL 20030828 ANDA ANDA076134 Ohm Laboratories Inc. LORATADINE 10 mg/1 51660-527_c3e4b813-6989-4a31-a908-c45ee194f5ea 51660-527 HUMAN OTC DRUG Allergy Relief Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Ohm Laboratories Inc. LORATADINE 10 mg/1 51660-572_d017745b-0f87-42dc-9d2c-be8ad495e953 51660-572 HUMAN PRESCRIPTION DRUG Delyla Levonorgestrel and Ethinyl Estradiol KIT 20140526 ANDA ANDA201108 OHM LABORATORIES INC. 51660-724_40f5bbd1-776e-45b7-8a29-91bd930cec2c 51660-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine loratadine and pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Ohm Laboratories Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 51660-904_623aa8f4-d84d-4dae-9fcb-51e2b288d52a 51660-904 HUMAN PRESCRIPTION DRUG VALACYCLOVIR VALACYCLOVIR HYDROCHLORIDE TABLET ORAL 20091125 ANDA ANDA076588 Ohm Laboratories Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 51660-905_623aa8f4-d84d-4dae-9fcb-51e2b288d52a 51660-905 HUMAN PRESCRIPTION DRUG VALACYCLOVIR VALACYCLOVIR HYDROCHLORIDE TABLET ORAL 20091125 ANDA ANDA076588 Ohm Laboratories Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 51660-939_84fefe79-0573-440b-bf2e-c836a616e2e3 51660-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Ohm Laboratories Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 51668-101_da1ab9ec-fdd3-4a0c-9d5c-1305aaf06b03 51668-101 HUMAN OTC DRUG Koh Gen Do Maifanshi Makeup Color Base Green zinc oxide, titanium dioxide CREAM TOPICAL 20080501 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE; ZINC OXIDE .85; 2.55 g/25g; g/25g 51668-102_da1ab9ec-fdd3-4a0c-9d5c-1305aaf06b03 51668-102 HUMAN OTC DRUG Koh Gen Do Maifanshi Makeup Color Base Pearl White zinc oxide, titanium dioxide CREAM TOPICAL 20080501 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE; ZINC OXIDE 1.0625; 2.55 g/25g; g/25g 51668-103_da1ab9ec-fdd3-4a0c-9d5c-1305aaf06b03 51668-103 HUMAN OTC DRUG Koh Gen Do Maifanshi Makeup Color Base Yellow zinc oxide, titanium dioxide CREAM TOPICAL 20080501 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE; ZINC OXIDE .85; 2.55 g/25g; g/25g 51668-104_da1ab9ec-fdd3-4a0c-9d5c-1305aaf06b03 51668-104 HUMAN OTC DRUG Koh Gen Do Maifanshi Makeup Color Base Lavender Pink zinc oxide, titanium dioxide CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE; ZINC OXIDE 1.056; 2.547 g/25g; g/25g 51668-201_8c6a2916-71df-4f0c-84b1-cda0260f44a6 51668-201 HUMAN OTC DRUG Koh Gen Do Maifanshi UV Face Powder titanium dioxide POWDER TOPICAL 20110825 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE .9558 g/12g 51668-401_636c2366-981d-4d12-a761-13a8751d09a9 51668-401 HUMAN OTC DRUG Koh Gen Do Maifanshi Triple Lighting Foundation BE-1 titanium dioxide POWDER TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE 1.179423 g/9g 51668-402_636c2366-981d-4d12-a761-13a8751d09a9 51668-402 HUMAN OTC DRUG Koh Gen Do Maifanshi Triple Lighting Foundation OC-1 titanium dioxide POWDER TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE 1.179423 g/9g 51668-403_636c2366-981d-4d12-a761-13a8751d09a9 51668-403 HUMAN OTC DRUG Koh Gen Do Maifanshi Triple Lighting Foundation OC-2 titanium dioxide POWDER TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE 1.179423 g/9g 51668-404_4a4dc72d-c5e4-404e-a791-9e831f7e5ecb 51668-404 HUMAN OTC DRUG Koh Gen DoTriple Lighting Foundation Titanium Dioxide POWDER TOPICAL 20110322 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE 13.1 g/100g 51668-405_636c2366-981d-4d12-a761-13a8751d09a9 51668-405 HUMAN OTC DRUG Koh Gen Do Maifanshi Triple Lighting Foundation BR-1 titanium dioxide POWDER TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE .895536 g/9g 51668-406_636c2366-981d-4d12-a761-13a8751d09a9 51668-406 HUMAN OTC DRUG Koh Gen Do Maifanshi Triple Lighting Foundation BR-2 titanium dioxide POWDER TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE .895536 g/9g 51668-501_64d648bb-7d55-4580-bd15-dfe05f6e6791 51668-501 HUMAN OTC DRUG Koh Gen Do Aqua Foundation BE-1 Aqua Foundation CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE; ZINC OXIDE 2.13; 1.38 mL/30mL; mL/30mL 51668-502_64d648bb-7d55-4580-bd15-dfe05f6e6791 51668-502 HUMAN OTC DRUG Koh Gen Do Aqua Foundation OC-1 Aqua Foundation CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE; ZINC OXIDE 2.19; 1.38 mL/30mL; mL/30mL 51668-503_64d648bb-7d55-4580-bd15-dfe05f6e6791 51668-503 HUMAN OTC DRUG Koh Gen Do Aqua Foundation OC-2 Aqua Foundation CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE; ZINC OXIDE 1.83; 1.38 mL/30mL; mL/30mL 51668-504_64d648bb-7d55-4580-bd15-dfe05f6e6791 51668-504 HUMAN OTC DRUG Koh Gen Do Aqua Foundation PK-1 Aqua Foundation CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE; ZINC OXIDE 2.16; 1.38 mL/30mL; mL/30mL 51668-505_21ef5a65-5faf-453d-b2e9-b4337d8deef4 51668-505 HUMAN OTC DRUG Koh Gen Do Aqua Foundation WT-00 Aqua Foundation CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE; ZINC OXIDE .972; .828 mL/18mL; mL/18mL 51668-506_64d648bb-7d55-4580-bd15-dfe05f6e6791 51668-506 HUMAN OTC DRUG Koh Gen Do Aqua Foundation OC-3 Aqua Foundation CREAM TOPICAL 20111103 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE; ZINC OXIDE 1.8; 1.38 mL/30mL; mL/30mL 51668-507_64d648bb-7d55-4580-bd15-dfe05f6e6791 51668-507 HUMAN OTC DRUG Koh Gen Do Aqua Foundation PK-0 Aqua Foundation CREAM TOPICAL 20111103 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE; ZINC OXIDE 2.31; 1.38 mL/30mL; mL/30mL 51668-508_64d648bb-7d55-4580-bd15-dfe05f6e6791 51668-508 HUMAN OTC DRUG Koh Gen Do Aqua Foundation PK-2 Aqua Foundation CREAM TOPICAL 20111103 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE; ZINC OXIDE 2.19; 1.38 mL/30mL; mL/30mL 51668-509_64d648bb-7d55-4580-bd15-dfe05f6e6791 51668-509 HUMAN OTC DRUG Koh Gen Do Aqua Foundation PK-3 Aqua Foundation CREAM TOPICAL 20111103 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.38 mL/30mL; mL/30mL 51670-100_2086586e-b29a-42dd-b191-7bd7f61caa99 51670-100 HUMAN OTC DRUG RECURO VAGINAL POVIDONE IODINE DOUCHE VAGINAL 20101025 OTC MONOGRAPH NOT FINAL part333E IONA PHARMACY POVIDONE-IODINE .3 mL/100mL 51672-1253_3680252c-a334-4c57-b58f-997c28ccba57 51672-1253 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19840626 NDA NDA019117 Taro Pharmaceuticals U.S.A., Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1254_3680252c-a334-4c57-b58f-997c28ccba57 51672-1254 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19890119 ANDA ANDA072494 Taro Pharmaceuticals U.S.A., Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1258_597f9b61-0bf3-4d21-8e70-92e93e63a33e 51672-1258 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 19960708 ANDA ANDA074249 Taro Pharmaceuticals U.S.A., Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1259_597f9b61-0bf3-4d21-8e70-92e93e63a33e 51672-1259 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate OINTMENT TOPICAL 19960712 ANDA ANDA074248 Taro Pharmaceuticals U.S.A., Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1260_a94c524d-f186-468b-88c8-325f99af3756 51672-1260 HUMAN PRESCRIPTION DRUG Clotrimazole Clotrimazole SOLUTION TOPICAL 19960729 ANDA ANDA074580 Taro Pharmaceuticals U.S.A., Inc. CLOTRIMAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 51672-1261_b563b5a0-5e4a-4b4b-96ab-cdfe867d08ef 51672-1261 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone GEL TOPICAL 19980714 ANDA ANDA074904 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1262_74ca2023-28b4-4129-9095-00261a71c05b 51672-1262 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 19960607 ANDA ANDA074286 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1263_b273a20b-15c8-4bf3-b68b-f776516281f6 51672-1263 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 19871222 ANDA ANDA062364 Taro Pharmaceuticals U.S.A., Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 51672-1264_3680252c-a334-4c57-b58f-997c28ccba57 51672-1264 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide OINTMENT TOPICAL 19990630 ANDA ANDA075008 Taro Pharmaceuticals U.S.A., Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1267_e24f57f1-b0f8-449e-b34e-348a80de71b7 51672-1267 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE DENTAL 19861001 ANDA ANDA070730 Taro Pharmaceuticals U.S.A., Inc. TRIAMCINOLONE ACETONIDE 1 mg/g 51672-1269_efb5243f-8795-44ea-a83d-ecf49c818645 51672-1269 HUMAN PRESCRIPTION DRUG BETAMETHASONE VALERATE Betamethasone Valerate CREAM TOPICAL 19880106 ANDA ANDA072041 Taro Pharmaceuticals U.S.A., Inc. BETAMETHASONE VALERATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1270_b563b5a0-5e4a-4b4b-96ab-cdfe867d08ef 51672-1270 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 19901130 ANDA ANDA073193 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1271_b563b5a0-5e4a-4b4b-96ab-cdfe867d08ef 51672-1271 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 19901130 ANDA ANDA073210 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1272_b273a20b-15c8-4bf3-b68b-f776516281f6 51672-1272 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide OINTMENT TOPICAL 19930329 ANDA ANDA063305 Taro Pharmaceuticals U.S.A., Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 51672-1273_a5769f35-5cbb-4deb-9e92-096d4faeb529 51672-1273 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide SOLUTION TOPICAL 19961231 ANDA ANDA074799 Taro Pharmaceuticals U.S.A., Inc. FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1274_4531f9df-12a0-43c8-b733-ba6109322703 51672-1274 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 19920430 ANDA ANDA073552 Taro Pharmaceuticals U.S.A., Inc. BETAMETHASONE DIPROPIONATE .64 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1275_70647750-4c62-44c4-a495-0af5d30c98e5 51672-1275 HUMAN PRESCRIPTION DRUG Clotrimazole Clotrimazole CREAM TOPICAL 19930831 ANDA ANDA072640 Taro Pharmaceuticals U.S.A., Inc. CLOTRIMAZOLE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 51672-1279_3680252c-a334-4c57-b58f-997c28ccba57 51672-1279 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide GEL TOPICAL 19970729 ANDA ANDA074935 Taro Pharmaceuticals U.S.A., Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1280_c8d93b2a-175c-4cff-b250-06b588c86101 51672-1280 HUMAN PRESCRIPTION DRUG Desonide Desonide CREAM TOPICAL 19920630 ANDA ANDA073548 Taro Pharmaceuticals U.S.A., Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1281_c8d93b2a-175c-4cff-b250-06b588c86101 51672-1281 HUMAN PRESCRIPTION DRUG Desonide Desonide OINTMENT TOPICAL 19940803 ANDA ANDA074254 Taro Pharmaceuticals U.S.A., Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1282_0e314bbe-0260-4a62-a9ef-c54c221fc09d 51672-1282 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19971126 ANDA ANDA040039 Taro Pharmaceuticals U.S.A., Inc. TRIAMCINOLONE ACETONIDE 1 mg/g 51672-1284_ab98ccaa-4654-4fa3-83a8-527eff5dd681 51672-1284 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 19940930 ANDA ANDA040037 Taro Pharmaceuticals U.S.A., Inc. TRIAMCINOLONE ACETONIDE 1 mg/g 51672-1289_886fd5e0-e2dc-4891-b16c-8b741d58a95c 51672-1289 HUMAN PRESCRIPTION DRUG Nystatin Nystatin CREAM TOPICAL 19930128 ANDA ANDA064022 Taro Pharmaceuticals U.S.A., Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 51672-1290_f7d09ff5-cd62-434d-9826-a0c3f7d1f30a 51672-1290 HUMAN PRESCRIPTION DRUG Hydrocortisone Valerate Hydrocortisone Valerate CREAM TOPICAL 19980825 ANDA ANDA075042 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1292_f7d09ff5-cd62-434d-9826-a0c3f7d1f30a 51672-1292 HUMAN PRESCRIPTION DRUG Hydrocortisone Valerate Hydrocortisone Valerate OINTMENT TOPICAL 19980825 ANDA ANDA075043 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1293_c87adfc9-9c84-40bd-8896-a7dcb6a324e5 51672-1293 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate SOLUTION TOPICAL 19981116 ANDA ANDA075224 Taro Pharmaceuticals U.S.A., Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1294_597f9b61-0bf3-4d21-8e70-92e93e63a33e 51672-1294 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate GEL TOPICAL 19990528 ANDA ANDA075279 Taro Pharmaceuticals U.S.A., Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1295_6e3813d1-b6cd-47f1-8189-fe23f272589b 51672-1295 HUMAN PRESCRIPTION DRUG Diflorasone Diacetate Diflorasone Diacetate OINTMENT TOPICAL 19990514 ANDA ANDA075331 Taro Pharmaceuticals U.S.A., Inc. DIFLORASONE DIACETATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1296_edb8010d-a022-40b6-8204-fd687178c9ae 51672-1296 HUMAN PRESCRIPTION DRUG Diflorasone Diacetate Diflorasone Diacetate CREAM TOPICAL 20000424 ANDA ANDA075508 Taro Pharmaceuticals U.S.A., Inc. DIFLORASONE DIACETATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1297_ad060a99-30c9-4f83-b7b1-321ac23d7b2e 51672-1297 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 20000517 ANDA ANDA075633 Taro Pharmaceuticals U.S.A., Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1298_07894997-e52a-4ee0-bff6-2edb13133ebf 51672-1298 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 Taro Pharmaceuticals U.S.A., Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 51672-1300_b2dec930-0ae6-4f5d-b143-1b9a6f32cc35 51672-1300 HUMAN PRESCRIPTION DRUG Ammonium Lactate Ammonium Lactate LOTION TOPICAL 20040528 ANDA ANDA076216 Taro Pharmaceuticals U.S.A., Inc. AMMONIUM LACTATE 120 mg/g 51672-1301_891b6fda-df39-4773-bd2a-ae8c68393e01 51672-1301 HUMAN PRESCRIPTION DRUG Ammonium Lactate Ammonium Lactate CREAM TOPICAL 20030410 ANDA ANDA075883 Taro Pharmaceuticals U.S.A., Inc. AMMONIUM LACTATE 120 mg/g 51672-1302_6433c4a3-250d-4615-9d62-b08a3c62b924 51672-1302 HUMAN PRESCRIPTION DRUG Terconazole Terconazole CREAM VAGINAL 20040406 ANDA ANDA075953 Taro Pharmaceuticals U.S.A., Inc. TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 51672-1303_9dc8b1b1-f749-4bc7-a34f-6f4383f71499 51672-1303 HUMAN PRESCRIPTION DRUG Econazole Nitrate Econazole Nitrate CREAM TOPICAL 20021126 ANDA ANDA076005 Taro Pharmaceuticals U.S.A., Inc. ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 51672-1304_9e19014b-b467-4045-88dd-96134272fa02 51672-1304 HUMAN PRESCRIPTION DRUG Terconazole Terconazole CREAM VAGINAL 20050119 ANDA ANDA076043 Taro Pharmaceuticals U.S.A., Inc. TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 51672-1305_01f52d0c-5b5c-4d6e-9ead-f62addf96719 51672-1305 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate SOLUTION TOPICAL 20060315 ANDA ANDA076788 Taro Pharmaceuticals U.S.A., Inc. MOMETASONE FUROATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1306_04a0b511-7296-46e2-b44f-6df435d401a6 51672-1306 HUMAN PRESCRIPTION DRUG Alclometasone dipropionate Alclometasone dipropionate CREAM TOPICAL 20050915 ANDA ANDA076587 Taro Pharmaceuticals U.S.A., Inc. ALCLOMETASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1308_f7d7d792-0173-44c1-b44c-9b13780e737a 51672-1308 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate LOTION TOPICAL 20040728 ANDA ANDA076493 Taro Pharmaceuticals U.S.A., Inc. BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE .5; 10 mg/mL; mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1309_af5bd729-6f9c-43f6-beae-abc434fdecf0 51672-1309 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate GEL TOPICAL 20031202 ANDA ANDA076508 Taro Pharmaceuticals U.S.A., Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1310_0e4f65d6-a754-424c-bba8-a87827e11e64 51672-1310 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM, AUGMENTED TOPICAL 20031209 ANDA ANDA076543 Taro Pharmaceuticals U.S.A., Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1311_2b22b19f-dfa5-4b3b-a9c0-05a6d4f573e6 51672-1311 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20041203 ANDA ANDA076624 Taro Pharmaceuticals U.S.A., Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1312_71d59e14-41c6-4f53-b294-e2c9e40dbf4f 51672-1312 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20050923 ANDA ANDA065170 Taro Pharmaceuticals U.S.A., Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 51672-1315_dc706733-71ff-40b2-95e0-ae3979a0edbf 51672-1315 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20041221 ANDA ANDA076679 Taro Pharmaceuticals U.S.A., Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1316_e489efa2-7ca5-4ab2-b081-a27439be2db1 51672-1316 HUMAN PRESCRIPTION DRUG Alclometasone Dipropionate Alclometasone dipropionate OINTMENT TOPICAL 20040729 ANDA ANDA076730 Taro Pharmaceuticals U.S.A., Inc. ALCLOMETASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1317_7eea1075-4726-4a2d-ab68-3ca1495d2ae3 51672-1317 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate OINTMENT, AUGMENTED TOPICAL 20041012 ANDA ANDA076753 Taro Pharmaceuticals U.S.A., Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1318_93dfcb34-d3a0-4296-ad79-bc911a7a8082 51672-1318 HUMAN PRESCRIPTION DRUG Ciclopirox Olamine ciclopirox olamine CREAM TOPICAL 20050412 ANDA ANDA076790 Taro Pharmaceuticals U.S.A., Inc. CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 51672-1321_a728761b-e177-4f50-afb6-7b0a415d4c55 51672-1321 HUMAN PRESCRIPTION DRUG Halobetasol Propionate Halobetasol Propionate CREAM TOPICAL 20050804 ANDA ANDA077227 Taro Pharmaceuticals U.S.A., Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1322_6685d3da-5148-4113-b65f-96ff9f20fdec 51672-1322 HUMAN PRESCRIPTION DRUG Halobetasol Propionate Halobetasol Propionate OINTMENT TOPICAL 20041216 ANDA ANDA076994 Taro Pharmaceuticals U.S.A., Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1323_055fcd4a-e5a2-4856-a9e1-e6dd2b22d28e 51672-1323 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SUSPENSION TOPICAL 20050810 ANDA ANDA077092 Taro Pharmaceuticals U.S.A., Inc. CICLOPIROX OLAMINE 7.7 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 51672-1326_a9ea50e1-ec17-4342-80f5-7bc6d7bc8cb9 51672-1326 HUMAN PRESCRIPTION DRUG Lustra Hydroquinone CREAM TOPICAL 20050120 UNAPPROVED DRUG OTHER Taro Pharmaceuticals U.S.A., Inc. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 51672-1327_a9ea50e1-ec17-4342-80f5-7bc6d7bc8cb9 51672-1327 HUMAN PRESCRIPTION DRUG Lustra-AF Hydroquinone CREAM TOPICAL 20050120 UNAPPROVED DRUG OTHER Taro Pharmaceuticals U.S.A., Inc. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 51672-1330_d4c3cb7a-21be-4d8e-a20c-90018539260b 51672-1330 HUMAN PRESCRIPTION DRUG Terconazole Terconazole SUPPOSITORY VAGINAL 20070309 ANDA ANDA077553 Taro Pharmaceuticals U.S.A., Inc. TERCONAZOLE 80 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 51672-1335_722c00c5-bd11-4d3d-8ad2-39b38b85cdd0 51672-1335 HUMAN PRESCRIPTION DRUG Oralone Triamcinolone Acetonide PASTE DENTAL 19861001 ANDA ANDA070730 Taro Pharmaceuticals U.S.A., Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1338_21f9746f-6e25-41c9-ba6c-6040913ea5c7 51672-1338 HUMAN PRESCRIPTION DRUG Flo-Pred Prednisolone Acetate SUSPENSION ORAL 20080117 NDA NDA022067 Taro Pharmaceuticals U.S.A., Inc. PREDNISOLONE ACETATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1340_6c6f5753-95cb-4f6b-9614-eb9e29124cdc 51672-1340 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate LOTION, AUGMENTED TOPICAL 20070521 ANDA ANDA077477 Taro Pharmaceuticals U.S.A., Inc. BETAMETHASONE DIPROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1346_ebca51fc-bda6-4932-8c37-4fd5e70dab5b 51672-1346 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SUSPENSION TOPICAL 20090520 ANDA ANDA078668 Taro Pharmaceuticals U.S.A., Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 51672-1348_0227f795-3481-40a1-9722-99fe1515b08a 51672-1348 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate SOLUTION ORAL 20120503 ANDA ANDA079121 Taro Pharmaceuticals U.S.A., Inc. ESCITALOPRAM OXALATE 5 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51672-1349_5fd8fa46-5b79-4c23-b694-f6e4481e60d2 51672-1349 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20110207 ANDA ANDA090347 Taro Pharmaceuticals U.S.A., Inc. RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] 51672-1350_f0f807ee-d921-4222-bff3-ff0b817f5fdb 51672-1350 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate LOTION TOPICAL 20120702 ANDA ANDA200302 Taro Pharmaceuticals U.S.A., Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1351_f8099c2f-42e4-4cd9-9b05-915fdbacf4f5 51672-1351 HUMAN PRESCRIPTION DRUG Ciclopirox ciclopirox SHAMPOO TOPICAL 20110223 ANDA ANDA090269 Taro Pharmaceuticals U.S.A., Inc. CICLOPIROX 10 mg/.96mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 51672-1352_1127d253-bd9e-4923-890a-fafe6064b8ae 51672-1352 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 19850117 NDA NDA018594 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1353_4730a056-e119-4a46-966c-8647dbb6ae38 51672-1353 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20140714 ANDA ANDA200734 Taro Pharmaceuticals U.S.A., Inc. FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-1358_b3581fe2-f68e-4218-b9ee-c17959789fc8 51672-1358 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION TOPICAL 20141126 ANDA ANDA203818 Taro Pharmaceuticals U.S.A., Inc. DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51672-2001_a1afea8d-75d9-4662-a6a4-5c76f271dffc 51672-2001 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate CREAM TOPICAL 19911001 OTC MONOGRAPH FINAL part333C Taro Pharmaceuticals U.S.A., Inc. MICONAZOLE NITRATE 20 mg/g 51672-2002_8a00e8c7-8ea8-4472-a27f-feca95647963 51672-2002 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 19950601 OTC MONOGRAPH FINAL part333C Taro Pharmaceuticals U.S.A., Inc. CLOTRIMAZOLE 1 g/100g 51672-2003_4e88541b-69a2-4c9d-8aca-0e053a646015 51672-2003 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM VAGINAL 19951204 ANDA ANDA072641 Taro Pharmaceuticals U.S.A., Inc. CLOTRIMAZOLE 1 g/100g 51672-2010_90beeb88-6729-42c9-a0ec-57a7ee196731 51672-2010 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20010913 OTC MONOGRAPH NOT FINAL part348 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE .5 g/100g 51672-2013_a7ccc7ea-73a2-4bed-8766-77607f6a9fbd 51672-2013 HUMAN OTC DRUG Hydrocortisone with Aloe Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Taro Phamaceuticals U.S.A., Inc. HYDROCORTISONE 1 g/100g 51672-2016_b38a7156-1b13-4e74-9e4b-bba288543b2f 51672-2016 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Taro Pharmaceuticals U.S.A., Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 51672-2018_ba64fa57-7065-49ff-a131-9155170cb494 51672-2018 HUMAN OTC DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE 1 g/100g 51672-2020_a9e3bbbc-2713-4fc8-9c14-70e823b6902a 51672-2020 HUMAN OTC DRUG Tolnaftate Antifungal Tolnaftate CREAM TOPICAL 19950101 OTC MONOGRAPH FINAL part333C Taro Pharmaceuticals U.S.A., Inc. TOLNAFTATE 1 g/100g 51672-2027_2507eb8e-f42a-4ae7-b1d9-3aea988623f4 51672-2027 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Taro Pharmaceuticals U.S.A., Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 51672-2030_129838bb-ece0-48f1-80ce-c3adf7f0ea13 51672-2030 HUMAN OTC DRUG Oxymetazoline Hydrochloride 12-Hour Oxymetazoline Hydrochloride SPRAY NASAL 20060225 OTC MONOGRAPH FINAL part341 Taro Pharmaceuticals U.S.A., Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 51672-2035_9a378ad1-5196-48b8-b446-e33f53e3b28f 51672-2035 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate CREAM VAGINAL 19970113 ANDA ANDA074444 Taro Pharmaceuticals U.S.A., Inc. MICONAZOLE NITRATE 20 mg/g 51672-2037_281b9bef-6149-414b-b0a2-a9cd9029228f 51672-2037 HUMAN OTC DRUG Clotrimazole Clotrimazole SOLUTION TOPICAL 19960501 OTC MONOGRAPH FINAL part333C Taro Pharmaceuticals U.S.A., Inc. CLOTRIMAZOLE 1 g/mL 51672-2062_6c5a5a10-2609-4cdd-aead-ed2b2586f8dd 51672-2062 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM VAGINAL 20000412 NDA NDA021143 Taro Pharmaceuticals U.S.A., Inc. CLOTRIMAZOLE 2 g/100g 51672-2063_28fde66d-7dff-4817-a35b-76cf135485a7 51672-2063 HUMAN OTC DRUG Hydrocortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE 1 g/100g 51672-2069_86cf0f9a-43b3-4f0a-b9b2-b82495d95b58 51672-2069 HUMAN OTC DRUG Hydrocortisone Acetate Antipruritic (Anti-Itch) Hydrocortisone Acetate CREAM TOPICAL 20010601 OTC MONOGRAPH NOT FINAL part348 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE ACETATE 1 g/100g 51672-2070_bedd3c8e-ead8-4e1e-8afb-481a8fa37aa0 51672-2070 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate CREAM VAGINAL 20050302 ANDA ANDA076773 Taro Pharmaceuticals U.S.A., Inc. MICONAZOLE NITRATE 40 mg/g 51672-2073_1ad0ccd1-b699-4068-be6f-cc6e0dcf03ea 51672-2073 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Taro Pharmaceuticals U.S.A., Inc. LORATADINE 5 mg/5mL 51672-2075_c1164186-f21c-4b67-9dea-6561a8753970 51672-2075 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Taro Pharmaceuticals U.S.A., Inc. BACITRACIN ZINC 500 [USP&apos'U]/g 51672-2080_09bbc0c5-b19b-4d06-bb37-e16d36da2f8c 51672-2080 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Taro Pharmaceuticals U.S.A., Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g 51672-2085_d7344c42-6a5f-4f30-bfb9-4c5724e47c24 51672-2085 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Taro Pharmaceuticals U.S.A., Inc. LORATADINE 5 mg/5mL 51672-2088_b143fc4b-485d-4dfb-9dfe-b3f5227666ec 51672-2088 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Taro Pharmaceuticals U.S.A., Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL 51672-2089_66a9522f-5353-4681-9895-bfc3b6512a77 51672-2089 HUMAN OTC DRUG Diphenhydramine Hydrochloride and Zinc Acetate Diphenhydramine Hydrochloride and Zinc Acetate CREAM TOPICAL 20050920 OTC MONOGRAPH NOT FINAL part348 Taro Pharmaceuticals U.S.A., Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g 51672-2092_3d7788e7-30d9-4822-b554-7006add0e1a8 51672-2092 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Taro Pharmaceuticals U.S.A., Inc. LORATADINE 5 mg/5mL 51672-2097_e9d6516f-a2d1-4746-81ce-2eb3172c7906 51672-2097 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20090722 ANDA ANDA078072 Taro Pharmaceuticals U.S.A., Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 51672-2102_032e6b85-f215-4a4e-8553-ddb5772b02a4 51672-2102 HUMAN OTC DRUG Childrens Cetirizine Hydrochloride Sugar Free Grape Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Taro Pharmaceuticals U.S.A., Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL 51672-2106_e409baed-c061-46a6-b747-92b3c42087fb 51672-2106 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Taro Pharmaceuticals U.S.A., Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL 51672-2112_70dba211-b688-4d4a-86e2-254f25c06297 51672-2112 HUMAN OTC DRUG Daytime Flu and Severe Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 Taro Pharmaceuticals U.S.A., Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 51672-2113_33bfb72f-29b8-4619-b466-1af80a12ff69 51672-2113 HUMAN OTC DRUG Nighttime Flu and Severe Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 Taro Pharmaceuticals U.S.A. Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 51672-2114_761f19c3-bee1-432b-a524-58abfd02c77f 51672-2114 HUMAN OTC DRUG Feverall Infants Acetaminophen SUPPOSITORY RECTAL 20131212 NDA NDA018337 Taro Pharmaceuticals U.S.A. Inc. ACETAMINOPHEN 80 mg/1 51672-2115_ee38a41a-eacd-4b2b-ac62-2341166696b8 51672-2115 HUMAN OTC DRUG Feverall Childrens Acetaminophen SUPPOSITORY RECTAL 20131212 NDA NDA018337 Taro Pharmaceuticals U.S.A. Inc. ACETAMINOPHEN 120 mg/1 51672-2116_dc1edff3-1af9-4ffe-90bd-ae1d76c48173 51672-2116 HUMAN OTC DRUG Feverall Jr. Strength Acetaminophen SUPPOSITORY RECTAL 20131212 NDA NDA018337 Taro Pharmaceuticals U.S.A. Inc. ACETAMINOPHEN 325 mg/1 51672-2117_d80387cf-d530-4c65-9e69-2c90c096f982 51672-2117 HUMAN OTC DRUG Feverall Adults Acetaminophen SUPPOSITORY RECTAL 20131212 NDA NDA018337 Taro Pharmaceuticals U.S.A. Inc. ACETAMINOPHEN 650 mg/1 51672-3003_74bdc874-8c34-46e4-8f11-25646e007056 51672-3003 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20050428 ANDA ANDA088799 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-3004_74bdc874-8c34-46e4-8f11-25646e007056 51672-3004 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20050428 ANDA ANDA086155 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-3007_179ee80a-20b0-436b-8689-570f31d7e8d6 51672-3007 HUMAN PRESCRIPTION DRUG Hydrocortisone and Acetic Acid Hydrocortisone and Acetic Acid SOLUTION AURICULAR (OTIC) 20050428 ANDA ANDA088759 Taro Pharmaceuticals U.S.A., Inc. ACETIC ACID; HYDROCORTISONE 20.8; 10.4 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-3008_956d695c-5abd-49cf-89cb-8f2837596f5d 51672-3008 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 19810817 ANDA ANDA086724 Taro Pharmaceuticals U.S.A., Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 51672-3009_e10a8fdf-4273-4083-864d-28fe6535c9a6 51672-3009 HUMAN PRESCRIPTION DRUG U-Cort Hydrocortisone Acetate CREAM TOPICAL 19880613 ANDA ANDA089472 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE ACETATE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-3020_c4c3c042-4b08-4424-85c9-d1ff6f798804 51672-3020 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20130325 ANDA ANDA086724 Taro Pharmaceuticals U.S.A., Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 51672-4001_c77d0608-d7a5-4bce-b03d-3603cc8bc1fa 51672-4001 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Taro Pharmaceuticals U.S.A., Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 51672-4002_c77d0608-d7a5-4bce-b03d-3603cc8bc1fa 51672-4002 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Taro Pharmaceuticals U.S.A., Inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 51672-4003_c77d0608-d7a5-4bce-b03d-3603cc8bc1fa 51672-4003 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Taro Pharmaceuticals U.S.A., Inc. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 51672-4004_c77d0608-d7a5-4bce-b03d-3603cc8bc1fa 51672-4004 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Taro Pharmaceuticals U.S.A., Inc. NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 51672-4005_e292116e-dfdc-4818-907f-6e691c1a783a 51672-4005 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 51672-4011_ed3b9d21-eab9-40e2-91a2-80936d598034 51672-4011 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Taro Pharmaceuticals U.S.A., Inc. CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 51672-4012_ed3b9d21-eab9-40e2-91a2-80936d598034 51672-4012 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Taro Pharmaceuticals U.S.A., Inc. CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 51672-4013_ed3b9d21-eab9-40e2-91a2-80936d598034 51672-4013 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Taro Pharmaceuticals U.S.A., Inc. CLOMIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 51672-4016_ac22b86c-e17f-4dd9-a6c7-b51e6626a150 51672-4016 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980430 ANDA ANDA075078 Taro Pharmaceuticals U.S.A., Inc. ETODOLAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51672-4017_ac22b86c-e17f-4dd9-a6c7-b51e6626a150 51672-4017 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980430 ANDA ANDA075078 Taro Pharmaceuticals U.S.A., Inc. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51672-4018_ac22b86c-e17f-4dd9-a6c7-b51e6626a150 51672-4018 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980311 ANDA ANDA075074 Taro Pharmaceuticals U.S.A., Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51672-4022_a8b47972-e8d4-4139-94ae-90e7fdc76647 51672-4022 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 19970528 ANDA ANDA040195 Taro Pharmaceuticals U.S.A., Inc. ACETAZOLAMIDE 125 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 51672-4023_a8b47972-e8d4-4139-94ae-90e7fdc76647 51672-4023 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 19970528 ANDA ANDA040195 Taro Pharmaceuticals U.S.A., Inc. ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 51672-4025_a61f4b02-2c3a-486d-8030-356f0b6961b4 51672-4025 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20010330 ANDA ANDA075424 Taro Pharmaceuticals U.S.A., Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 51672-4026_7f3670d2-9267-49b6-b925-ec18b5aa0777 51672-4026 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615 ANDA ANDA075319 Taro Pharmaceuticals U.S.A., Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 51672-4027_ffa3ce67-3269-4938-a461-4245782d1e4b 51672-4027 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51672-4028_ffa3ce67-3269-4938-a461-4245782d1e4b 51672-4028 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51672-4029_ffa3ce67-3269-4938-a461-4245782d1e4b 51672-4029 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51672-4030_ffa3ce67-3269-4938-a461-4245782d1e4b 51672-4030 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51672-4031_ffa3ce67-3269-4938-a461-4245782d1e4b 51672-4031 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51672-4032_ffa3ce67-3269-4938-a461-4245782d1e4b 51672-4032 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51672-4033_ffa3ce67-3269-4938-a461-4245782d1e4b 51672-4033 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51672-4034_ffa3ce67-3269-4938-a461-4245782d1e4b 51672-4034 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51672-4035_ffa3ce67-3269-4938-a461-4245782d1e4b 51672-4035 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 51672-4036_ac22b86c-e17f-4dd9-a6c7-b51e6626a150 51672-4036 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20000425 ANDA ANDA075074 Taro Pharmaceuticals U.S.A., Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51672-4037_efd63989-b5e6-4143-9e71-2fee51fb7ef8 51672-4037 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20010123 ANDA ANDA075657 Taro Pharmaceuticals U.S.A., Inc. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 51672-4038_efd63989-b5e6-4143-9e71-2fee51fb7ef8 51672-4038 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20010123 ANDA ANDA075657 Taro Pharmaceuticals U.S.A., Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 51672-4039_efd63989-b5e6-4143-9e71-2fee51fb7ef8 51672-4039 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20010123 ANDA ANDA075657 Taro Pharmaceuticals U.S.A., Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 51672-4040_efd63989-b5e6-4143-9e71-2fee51fb7ef8 51672-4040 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20010123 ANDA ANDA075657 Taro Pharmaceuticals U.S.A., Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 51672-4041_e292116e-dfdc-4818-907f-6e691c1a783a 51672-4041 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, CHEWABLE ORAL 20001024 ANDA ANDA075687 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 51672-4042_032414be-07b6-4ba9-8150-be7056140715 51672-4042 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20000427 ANDA ANDA075731 Taro Pharmaceuticals U.S.A., Inc. CLORAZEPATE DIPOTASSIUM 3.75 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51672-4043_032414be-07b6-4ba9-8150-be7056140715 51672-4043 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20000427 ANDA ANDA075731 Taro Pharmaceuticals U.S.A., Inc. CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51672-4044_032414be-07b6-4ba9-8150-be7056140715 51672-4044 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20000427 ANDA ANDA075731 Taro Pharmaceuticals U.S.A., Inc. CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 51672-4045_22779a20-b88b-48cf-b457-b9fa52c2165c 51672-4045 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleate and Hydrochlorothiazide TABLET ORAL 20010918 ANDA ANDA075788 Taro Pharmaceuticals U.S.A., Inc. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 5; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51672-4046_22779a20-b88b-48cf-b457-b9fa52c2165c 51672-4046 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleate and Hydrochlorothiazide TABLET ORAL 20010918 ANDA ANDA075788 Taro Pharmaceuticals U.S.A., Inc. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 51672-4047_e292116e-dfdc-4818-907f-6e691c1a783a 51672-4047 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine SUSPENSION ORAL 20040920 ANDA ANDA076729 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 100 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 51672-4048_740d2537-071d-4871-aea6-ea96f83ebac4 51672-4048 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20010529 ANDA ANDA075673 Taro Pharmaceuticals U.S.A., Inc. BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE .5; 10 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-4051_defccc56-755b-42c3-9dc5-776e9553efaf 51672-4051 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 Taro Pharmaceuticals U.S.A., Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51672-4052_defccc56-755b-42c3-9dc5-776e9553efaf 51672-4052 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 Taro Pharmaceuticals U.S.A., Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51672-4053_defccc56-755b-42c3-9dc5-776e9553efaf 51672-4053 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 Taro Pharmaceuticals U.S.A., Inc. ETODOLAC 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51672-4054_33e00bbf-103a-4df9-b31b-4cd711916f59 51672-4054 HUMAN PRESCRIPTION DRUG Amcinonide Amcinonide CREAM TOPICAL 20020531 ANDA ANDA076229 Taro Pharmaceuticals U.S.A., Inc. AMCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-4055_a61f4b02-2c3a-486d-8030-356f0b6961b4 51672-4055 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20010330 ANDA ANDA075424 Taro Pharmaceuticals U.S.A., Inc. AMIODARONE HYDROCHLORIDE 100 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 51672-4057_a61f4b02-2c3a-486d-8030-356f0b6961b4 51672-4057 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20021129 ANDA ANDA076362 Taro Pharmaceuticals U.S.A., Inc. AMIODARONE HYDROCHLORIDE 400 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 51672-4060_33e00bbf-103a-4df9-b31b-4cd711916f59 51672-4060 HUMAN PRESCRIPTION DRUG Amcinonide Amcinonide OINTMENT TOPICAL 20030319 ANDA ANDA076367 Taro Pharmaceuticals U.S.A., Inc. AMCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-4061_66584547-d6af-4afe-abc3-392116658ebd 51672-4061 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate Hydrocortisone Butyrate SOLUTION TOPICAL 20040114 ANDA ANDA076364 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE BUTYRATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-4062_768f2866-96ff-434c-abfc-1233c9de043e 51672-4062 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil SOLUTION TOPICAL 20031105 ANDA ANDA076526 Taro Pharmaceuticals U.S.A., Inc. FLUOROURACIL 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 51672-4063_768f2866-96ff-434c-abfc-1233c9de043e 51672-4063 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil SOLUTION TOPICAL 20031105 ANDA ANDA076526 Taro Pharmaceuticals U.S.A., Inc. FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 51672-4064_05ebb13b-3b07-4df5-92be-ff9ede381ad7 51672-4064 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076507 Taro Pharmaceuticals U.S.A., Inc. FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 51672-4065_05ebb13b-3b07-4df5-92be-ff9ede381ad7 51672-4065 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076507 Taro Pharmaceuticals U.S.A., Inc. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 51672-4066_05ebb13b-3b07-4df5-92be-ff9ede381ad7 51672-4066 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076507 Taro Pharmaceuticals U.S.A., Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 51672-4067_05ebb13b-3b07-4df5-92be-ff9ede381ad7 51672-4067 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076507 Taro Pharmaceuticals U.S.A., Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 51672-4069_0af1aee0-2980-46b3-bc50-c67974f863bc 51672-4069 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20040408 ANDA ANDA040521 Taro Pharmaceuticals U.S.A., Inc. PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51672-4070_596c253a-e4fb-4c55-ad1d-f593aacd21d3 51672-4070 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20140501 ANDA ANDA076601 Taro Pharmaceuticals U.S.A., Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 51672-4074_66584547-d6af-4afe-abc3-392116658ebd 51672-4074 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate Hydrocortisone Butyrate CREAM TOPICAL 20050804 ANDA ANDA076654 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-4075_48723753-8184-4cf9-b47b-f6bf8856636e 51672-4075 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin SOLUTION ORAL 20130703 ANDA ANDA076672 Taro Pharmaceuticals U.S.A., Inc. GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51672-4079_88a49efc-2967-4ee4-af03-a6dfbc031ecf 51672-4079 HUMAN PRESCRIPTION DRUG Desonide Desonide LOTION TOPICAL 20141031 ANDA ANDA202161 Taro Pharmaceuticals U.S.A., Inc. DESONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-4081_c4aa5dee-e3ca-4727-9886-11f8c2261283 51672-4081 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate Clindamycin phosphate SOLUTION TOPICAL 20040331 ANDA ANDA065184 Taro Pharmaceuticals U.S.A., Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 51672-4083_66584547-d6af-4afe-abc3-392116658ebd 51672-4083 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate Hydrocortisone Butyrate OINTMENT TOPICAL 20041227 ANDA ANDA076842 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-4088_3c0a2ad5-9008-4b01-a4ef-bf5531dab11e 51672-4088 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20061218 ANDA ANDA076918 Taro Pharmaceuticals U.S.A., Inc. FLUCONAZOLE 350 mg/35mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 51672-4089_3c0a2ad5-9008-4b01-a4ef-bf5531dab11e 51672-4089 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20061218 ANDA ANDA076918 Taro Pharmaceuticals U.S.A., Inc. FLUCONAZOLE 1400 mg/35mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 51672-4091_d5064e1b-1564-45ef-b8d6-85dd13e75b69 51672-4091 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron hydrochloride SOLUTION ORAL 20071130 ANDA ANDA077009 Taro Pharmaceuticals U.S.A., Inc. ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 51672-4095_6359624d-5d38-47db-8ae5-214ff908179d 51672-4095 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate OINTMENT TOPICAL 20050614 ANDA ANDA077145 Taro Pharmaceuticals U.S.A., Inc. FLUTICASONE PROPIONATE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-4105_d4292ac7-519a-4a92-be8d-1d1bc4635522 51672-4105 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20071115 ANDA ANDA077801 Taro Pharmaceuticals U.S.A., Inc. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51672-4106_d4292ac7-519a-4a92-be8d-1d1bc4635522 51672-4106 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20071115 ANDA ANDA077801 Taro Pharmaceuticals U.S.A., Inc. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51672-4107_d4292ac7-519a-4a92-be8d-1d1bc4635522 51672-4107 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20071115 ANDA ANDA077801 Taro Pharmaceuticals U.S.A., Inc. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51672-4108_02c93e5e-bc97-483b-9442-ea0446bb0be8 51672-4108 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20110328 ANDA ANDA077729 Taro Pharmaceuticals U.S.A., Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 51672-4109_02c93e5e-bc97-483b-9442-ea0446bb0be8 51672-4109 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20110328 ANDA ANDA077729 Taro Pharmaceuticals U.S.A., Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 51672-4110_02c93e5e-bc97-483b-9442-ea0446bb0be8 51672-4110 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20110328 ANDA ANDA077729 Taro Pharmaceuticals U.S.A., Inc. ONDANSETRON HYDROCHLORIDE 24 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 51672-4111_53235f4b-35de-4f23-a063-5fda31e11745 51672-4111 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20060905 ANDA ANDA040684 Taro Pharmaceuticals U.S.A., Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51672-4116_c4d0e74b-e6ba-48f1-8601-f57f2a70cd79 51672-4116 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole GEL TOPICAL 20060718 ANDA ANDA077819 Taro Pharmaceuticals U.S.A., Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 51672-4117_e9a9d100-81bf-4514-b8ad-170e9a12d342 51672-4117 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 19880229 ANDA ANDA062876 Taro Pharmaceuticals U.S.A., Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 51672-4118_838583b2-b014-48f0-9cf2-da8e57511678 51672-4118 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil CREAM TOPICAL 20100305 ANDA ANDA090368 Taro Pharmaceuticals U.S.A., Inc. FLUOROURACIL 50 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 51672-4123_e292116e-dfdc-4818-907f-6e691c1a783a 51672-4123 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, EXTENDED RELEASE ORAL 20090331 ANDA ANDA078115 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 51672-4124_e292116e-dfdc-4818-907f-6e691c1a783a 51672-4124 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, EXTENDED RELEASE ORAL 20090331 ANDA ANDA078115 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 51672-4125_e292116e-dfdc-4818-907f-6e691c1a783a 51672-4125 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, EXTENDED RELEASE ORAL 20090331 ANDA ANDA078115 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 51672-4130_9773373b-08d3-4a6d-91cf-6610303fd823 51672-4130 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078525 Taro Pharmaceuticals U.S.A., Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 51672-4131_9773373b-08d3-4a6d-91cf-6610303fd823 51672-4131 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078525 Taro Pharmaceuticals U.S.A., Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 51672-4132_9773373b-08d3-4a6d-91cf-6610303fd823 51672-4132 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078525 Taro Pharmaceuticals U.S.A., Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 51672-4133_9773373b-08d3-4a6d-91cf-6610303fd823 51672-4133 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078525 Taro Pharmaceuticals U.S.A., Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 51672-4136_324e9d54-0985-423b-bfca-f6e0bd2ed4ac 51672-4136 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090210 ANDA ANDA078774 Taro Pharmaceuticals U.S.A., Inc. LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51672-4137_324e9d54-0985-423b-bfca-f6e0bd2ed4ac 51672-4137 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20100201 ANDA ANDA078960 Taro Pharmaceuticals U.S.A., Inc. LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51672-4138_792dd502-e445-4b74-b5f9-a946e4c3f57e 51672-4138 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride TABLET, FILM COATED ORAL 20100528 ANDA ANDA090817 Taro Pharmaceuticals U.S.A., Inc. GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 51672-4139_4352ff08-e639-4f77-8d09-d4d8b039e98f 51672-4139 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090204 ANDA ANDA079204 Taro Pharmaceuticals U.S.A., Inc. LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 51672-4140_4352ff08-e639-4f77-8d09-d4d8b039e98f 51672-4140 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090204 ANDA ANDA079204 Taro Pharmaceuticals U.S.A., Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 51672-4141_324e9d54-0985-423b-bfca-f6e0bd2ed4ac 51672-4141 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20100201 ANDA ANDA078960 Taro Pharmaceuticals U.S.A., Inc. LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51672-4142_324e9d54-0985-423b-bfca-f6e0bd2ed4ac 51672-4142 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20100201 ANDA ANDA078960 Taro Pharmaceuticals U.S.A., Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51672-4143_324e9d54-0985-423b-bfca-f6e0bd2ed4ac 51672-4143 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20100201 ANDA ANDA078960 Taro Pharmaceuticals U.S.A., Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51672-4144_56dd77b4-82ca-4556-a3d6-fc0d1e88ca29 51672-4144 HUMAN PRESCRIPTION DRUG DARANIDE dichlorphenamide TABLET ORAL 20120316 NDA NDA011366 Taro Pharmaceuticals U.S.A., Inc. DICHLORPHENAMIDE 50 mg/1 51672-4145_b2fbfa9a-f80b-40ea-9bf3-ebc91fe5e970 51672-4145 HUMAN PRESCRIPTION DRUG Imiquimod Imiquimod CREAM TOPICAL 20110415 ANDA ANDA200173 Taro Pharmaceuticals U.S.A., Inc. IMIQUIMOD 50 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 51672-4146_1245211d-54a1-4e5b-801f-e842e0e2d9f7 51672-4146 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin TABLET, CHEWABLE ORAL 20140417 ANDA ANDA200565 Taro Pharmaceuticals U.S.A., Inc PHENYTOIN 50 g/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51672-4147_8ab0fb0e-0f17-41d5-8fc6-6fa87412b265 51672-4147 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20110523 ANDA ANDA200998 Taro Pharmaceuticals U.S.A., Inc. MEPROBAMATE 200 mg/1 CIV 51672-4148_8ab0fb0e-0f17-41d5-8fc6-6fa87412b265 51672-4148 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20110523 ANDA ANDA200998 Taro Pharmaceuticals U.S.A., Inc. MEPROBAMATE 400 mg/1 CIV 51672-4149_a14d0afb-9662-4eb8-bf0b-1ad220873f90 51672-4149 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20130621 ANDA ANDA201106 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 51672-4150_a14d0afb-9662-4eb8-bf0b-1ad220873f90 51672-4150 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20130621 ANDA ANDA201106 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 51672-4151_a14d0afb-9662-4eb8-bf0b-1ad220873f90 51672-4151 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20130621 ANDA ANDA201106 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 51672-4154_63587cb5-a2b7-4c1c-95cf-3333566fdee8 51672-4154 HUMAN PRESCRIPTION DRUG Calcipotriene Calcipotriene OINTMENT TOPICAL 20100324 ANDA ANDA090633 Taro Pharmaceuticals U.S.A., Inc. CALCIPOTRIENE .05 mg/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 51672-4155_9ad52567-50fc-4046-812b-7a3f01492444 51672-4155 HUMAN PRESCRIPTION DRUG Adapalene Adapalene GEL TOPICAL 19960531 NDA AUTHORIZED GENERIC NDA020380 Taro Pharmaceuticals U.S.A., Inc. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 51672-4161_a750c178-b2c9-4575-93cd-cca0823bfd80 51672-4161 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine dihydrochloride SOLUTION ORAL 20130726 ANDA ANDA202673 Taro Pharmaceuticals U.S.A., inc. LEVOCETIRIZINE DIHYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 51672-5202_7a17688b-fca9-47ca-b164-83977cbf460f 51672-5202 HUMAN PRESCRIPTION DRUG Topicort Desoximetasone GEL TOPICAL 19980714 ANDA ANDA074904 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-5203_8c01b42a-db87-4e0e-a662-26ec24b9ba26 51672-5203 HUMAN PRESCRIPTION DRUG Topicort Desoximetasone OINTMENT TOPICAL 19921215 ANDA ANDA074286 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-5204_7a17688b-fca9-47ca-b164-83977cbf460f 51672-5204 HUMAN PRESCRIPTION DRUG Topicort Desoximetasone CREAM TOPICAL 19901130 ANDA ANDA073193 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-5205_7a17688b-fca9-47ca-b164-83977cbf460f 51672-5205 HUMAN PRESCRIPTION DRUG Topicort Desoximetasone CREAM TOPICAL 19901130 ANDA ANDA073210 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-5263_cbfe3c09-149e-443f-be37-514ba3c4dda4 51672-5263 HUMAN PRESCRIPTION DRUG Topicort Desoximetasone OINTMENT TOPICAL 19850117 NDA NDA018594 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-5276_b25a87f3-4f04-4af3-8764-2cd11ef99913 51672-5276 HUMAN PRESCRIPTION DRUG OVIDE MALATHION LOTION TOPICAL 19820802 NDA NDA018613 TARO PHARMACEUTICALS USA, INC. MALATHION .005 g/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 51672-5277_a3510c3b-9538-4ce6-9736-95f9079c71c8 51672-5277 HUMAN PRESCRIPTION DRUG MALATHION MALATHION LOTION TOPICAL 20090802 NDA NDA018613 TARO PHARMACEUTICALS U.S.A., INC. MALATHION .005 g/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 51672-5278_73697e23-5b86-4c5a-8aaf-af73af066e76 51672-5278 HUMAN PRESCRIPTION DRUG Calcitrene Calcipotriene OINTMENT TOPICAL 20100324 ANDA ANDA090633 Taro Pharmaceuticals U.S.A., Inc. CALCIPOTRIENE .05 mg/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 51672-5281_e5ccb34e-86d8-48a9-8b5d-0a0a12c662a0 51672-5281 HUMAN PRESCRIPTION DRUG Topicort Desoximetasone SPRAY TOPICAL 20130411 NDA NDA204141 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE 2.5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-5292_45be2554-d93f-4f4e-a212-c12eea0afdd2 51672-5292 HUMAN PRESCRIPTION DRUG psorcon Diflorasone Diacetate CREAM TOPICAL 20140801 ANDA ANDA075508 Taro Pharmaceuticals U.S.A., Inc. DIFLORASONE DIACETATE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51672-5293_56cd9886-2003-4e81-bef4-8b9c2d00c42b 51672-5293 HUMAN PRESCRIPTION DRUG Ovide Malathion LOTION TOPICAL 20140131 ANDA ANDA091559 Taro Pharmaceuticals U.S.A., Inc. MALATHION .0005 g/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 51672-5294_6023342b-5c41-4990-8403-d554a3323088 51672-5294 HUMAN PRESCRIPTION DRUG Malathion Malathion LOTION TOPICAL 20140131 ANDA ANDA091559 Taro Pharmaceuticals U.S.A., Inc. MALATHION .0005 g/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 51672-5295_f3698d33-814b-4ad1-8aa8-0728b8041dcc 51672-5295 HUMAN PRESCRIPTION DRUG metronidazole metronidazole GEL TOPICAL 20050630 NDA AUTHORIZED GENERIC NDA021789 Taro Pharmaceuticals U.S.A., Inc. METRONIDAZOLE 10 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 51673-001_93eef5c7-3b70-4633-b4ed-c5ba1aafe228 51673-001 HUMAN OTC DRUG ZANG QI CAMPHOR (NATURAL) PLASTER TRANSDERMAL 20100604 OTC MONOGRAPH NOT FINAL part348 QINGHAI ZANGYUANTANG BIO-TECH CO LTD CAMPHOR (NATURAL) 3.1 g/1 51681-0001_3957b480-1b0b-47de-8ee4-2822d1478cb6 51681-0001 HUMAN OTC DRUG WHITE FLOWER ANALGESIC BALM CAMPHOR, MENTHOL, AND METHYL SALICYLATE OIL TRANSDERMAL 20100614 OTC MONOGRAPH NOT FINAL part348 JELMA PHILIPPINES INC CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 6; 14.6; 40 g/100mL; g/100mL; g/100mL 51681-0011_dea788c1-49a7-4f2a-8e70-792372de679d 51681-0011 HUMAN OTC DRUG WHITE FLOWER ANALGESIC BALM FLORAL SCENTED CAMPHOR, MENTHOL AND METHYL SALICYLATE OIL TOPICAL 20100720 OTC MONOGRAPH NOT FINAL part348 JELMA PHILIPPINES INC CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 5.4; 13; 35.8 g/100mL; g/100mL; g/100mL 51681-0041_ac4655a0-6c2f-4cbd-ad49-9c57c85e7798 51681-0041 HUMAN OTC DRUG WHITE FLOWER STRAIN RELIEF CAMPHOR, MENTHOL AND METHYL SALICYLATE OIL TOPICAL 20120220 OTC MONOGRAPH NOT FINAL part348 JELMA PHILIPPINES INC CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 10; 15; 50 g/100mL; g/100mL; g/100mL 51683-000_10805e60-edd4-406d-b131-49c7e221caa8 51683-000 HUMAN OTC DRUG SOTHYS PARIS Sunscreen Face and Body Broad Spectrum SPF 30 UVA/UVB AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20140209 OTC MONOGRAPH NOT FINAL part352 Sothys Paris AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL 51688-5473_9e69db8b-c8f3-447b-b3fb-632f4d685919 51688-5473 HUMAN OTC DRUG Povidone-Iodine Povidone-Iodine SOLUTION TOPICAL 19840103 OTC MONOGRAPH NOT FINAL part333A Smiths Medical ASD, INC POVIDONE-IODINE 9.8 g/100g 51693-001_2331f0d5-5876-48a6-b2ff-2c836464777e 51693-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19860101 UNAPPROVED MEDICAL GAS Ridgeview Home Medical Equipment OXYGEN 99 L/100L 51702-114_178df289-8507-479d-9354-6cb3e8f47f61 51702-114 HUMAN OTC DRUG Sun Defeated Sunscreen Avobenzone, Octocrylene, Oxybenzone, Octisalate LOTION TOPICAL 20120312 OTC MONOGRAPH FINAL part352 Mission AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.79; 7.44; 6.51; 3.74 g/93g; g/93g; g/93g; g/93g 51706-111_bf81f0a8-7645-4682-9957-2f05c5a2de31 51706-111 HUMAN OTC DRUG Bodycology Cherry Blossom Triclosan GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Landy International TRICLOSAN .3 mL/100mL 51706-112_99e4408e-8ce2-4281-af5a-339628a33b35 51706-112 HUMAN OTC DRUG Bodycology Coconut Lime Triclosan CREAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Landy International TRICLOSAN .3 mL/100mL 51706-113_9bb371f4-f52a-4483-a20a-f64993c887d6 51706-113 HUMAN OTC DRUG Bodycology Brown Sugar Vanilla Triclosan GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Landy International TRICLOSAN .3 mL/100mL 51706-114_a19ec217-eaa7-4af8-8fba-b494d3219631 51706-114 HUMAN OTC DRUG Bodycology Cucumber Melon Triclosan GEL TOPICAL 20100616 OTC MONOGRAPH NOT FINAL part333 Landy International TRICLOSAN .3 mL/100mL 51706-115_2a321d39-b474-42e0-90bf-d74d547808de 51706-115 HUMAN OTC DRUG Bodycology White Gardenia Triclosan GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Landy International TRICLOSAN .3 mL/100mL 51706-201_50a66a9f-2070-4b0f-a76e-115b64beef87 51706-201 HUMAN OTC DRUG Bodycology Cherry Blossom Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100625 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 65 mL/100mL 51706-202_024d5dcf-ac54-4317-bd9d-759d69634ac5 51706-202 HUMAN OTC DRUG Bodycology Brown Sugar Vanilla Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100625 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 65 mL/100mL 51706-203_ecc1529e-af2c-4d0e-aa72-71f49871932e 51706-203 HUMAN OTC DRUG Bodycology Cucumber Melon Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100708 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 65 mL/100mL 51706-204_ca326053-21ac-4ccc-b753-86d0df355d97 51706-204 HUMAN OTC DRUG Bodycology Sweet Petals Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100625 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 65 mL/100mL 51706-205_e9dfdede-10b3-4a31-99ae-edf9fc6dbd43 51706-205 HUMAN OTC DRUG Bodycology Sweet Petals Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100708 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 65 mL/100mL 51706-301_a49075de-c21d-4650-b638-5c4b1e4128af 51706-301 HUMAN OTC DRUG Bodycology Moisturizing Hand Sanitizer Brown Sugar Vanilla Alcohol CREAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 70 mL/100mL 51706-302_be355741-e4dd-4155-aab2-712a827a67be 51706-302 HUMAN OTC DRUG Bodycology Moisturizing Hand Sanitizer Cherry Blossom Alcohol CREAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 70 mL/100mL 51706-303_605b3afa-c2b9-4acf-95e3-d51b9eb4f881 51706-303 HUMAN OTC DRUG Bodycology Moisturizing Hand Sanitizer Cucumber Melon Alcohol GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 70 mL/100mL 51706-304_8dcab923-01a5-4976-bbf2-a5c8ce226925 51706-304 HUMAN OTC DRUG Bodycology Moisturizing Hand Sanitizer Midnight Garden Alcohol GEL TOPICAL 20100630 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 70 mL/100mL 51706-305_f477a18a-38aa-43db-8f68-87f194bc0197 51706-305 HUMAN OTC DRUG Bodycology Moisturizing Hand Sanitizer Sweet Petals Alcohol GEL TOPICAL 20100630 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 70 mL/100mL 51706-306_31421adc-3ff9-416f-a021-feb887e0f861 51706-306 HUMAN OTC DRUG Bodycology Moisturizing Hand Sanitzer White Gardenia Alcohol CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 70 mL/100mL 51706-400_96121232-d21c-48e3-828e-1e23a96589d1 51706-400 HUMAN OTC DRUG Bodycology Hand Sanitizer Gift Set Ethyl Alcohol GEL TOPICAL 20100813 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 70 mL/100mL 51706-500_811e59bd-c138-4c5e-ac46-038eec5c51bc 51706-500 HUMAN OTC DRUG HAND SANITIZER ALCOHOL GEL TOPICAL 20120614 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL 51706-501_2115792b-d753-40ca-a074-dc810ff024cb 51706-501 HUMAN OTC DRUG Hand Sanitizer Pink Strawberry Lollipop Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL 51706-502_2d357b05-7d8b-49cb-944d-d5dc8c97a35c 51706-502 HUMAN OTC DRUG Hand Sanitizer Winter Jelly Bean Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL 51706-503_1338852a-4594-4d4b-b2f7-5ec66bd18641 51706-503 HUMAN OTC DRUG Hand Sanitizer Passionfruit Pomegranate Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL 51706-504_02b9d687-f30d-4828-8ed5-320e68b72dde 51706-504 HUMAN OTC DRUG Hand Sanitizer Orange Tangerine Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL 51706-505_8069383e-249b-4b4e-b8ea-5c27a995b11a 51706-505 HUMAN OTC DRUG Hand Sanitizer Sweet Sugar Cookie Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL 51706-506_c04a2408-4cb6-41c6-9d02-70b890e2f279 51706-506 HUMAN OTC DRUG Hand Sanitizer Passionfruit Pomegranate Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL 51706-507_d94dc316-669e-4d73-99e7-fb45d6d1b82d 51706-507 HUMAN OTC DRUG Hand Sanitizer Spicy Peppermint Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL 51706-508_0e1a0fb6-f1d2-4e1e-8556-5a4d83c35687 51706-508 HUMAN OTC DRUG Hand Sanitizer Sugared Berry Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL 51706-509_55f1ecc6-097b-495b-9daa-67d71a650598 51706-509 HUMAN OTC DRUG Hand Sanitizer Cranberry Tart Alcohol LIQUID TOPICAL 20140418 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL 51706-510_2c43ad0a-0284-4721-8ec8-b92a0eaed81e 51706-510 HUMAN OTC DRUG Hand Sanitizer Sugar Coated Plum Alcohol LIQUID TOPICAL 20140418 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL 51715-001_f1fe3676-395d-43e8-b4c1-5441c70424d9 51715-001 HUMAN OTC DRUG Lidocoll Lidocaine HCL SPRAY TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part348 Innocoll Pharmaceuticals LIDOCAINE HYDROCHLORIDE 4.6 g/115g 51718-2111_e70b65c3-ebc2-43fd-afdb-21e0763deccb 51718-2111 HUMAN OTC DRUG Instant Hand Sanitizer Citrus Scent alcohol GEL TOPICAL 20100826 OTC MONOGRAPH NOT FINAL part333E Telestar Consulting ALCOHOL .665 g/mL 51718-3111_728681d6-f63b-4c1c-8522-ad2c50badb01 51718-3111 HUMAN OTC DRUG Antiseptic alcohol LIQUID TOPICAL 20120320 OTC MONOGRAPH NOT FINAL part333E Telestar Consulting ALCOHOL 665 mL/L 51720-421_817bad9e-3bc0-44bd-b626-e1c6def461fb 51720-421 HUMAN OTC DRUG Berberis Antiseptic Berberis Aquifolium, Calendula Officinalis, Hydrastis Canadensis, Acid Boric, Zinc Oxide, Borax, Calcium Sulphate, Antimonium Crudum CREAM TOPICAL 20090815 UNAPPROVED HOMEOPATHIC Curative Power Lab PVT LTD ANTIMONY TRISULFIDE; BORIC ACID; CALCIUM SULFATE; CALENDULA OFFICINALIS FLOWERING TOP; GOLDENSEAL; MAHONIA AQUIFOLIUM ROOT BARK; SODIUM BORATE; ZINC OXIDE 1; 1; 1; 2; 2; 2; 1; 1 [hp_X]/21g; [hp_X]/21g; [hp_X]/21g; [hp_X]/21g; [hp_X]/21g; [hp_X]/21g; [hp_X]/21g; [hp_X]/21g 51720-653_8dd9c95b-fd76-4c58-bfa0-c2125dd52270 51720-653 HUMAN OTC DRUG Tyn Mans Natrum Salicylicum, Kalium Iodatum, Caffeine, Natrum Citricum, Cimicifuga TINCTURE ORAL 20090815 UNAPPROVED HOMEOPATHIC Curative Power Lab PVT LTD BLACK COHOSH; CAFFEINE; POTASSIUM IODIDE; SODIUM CITRATE; SODIUM SALICYLATE 6; 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 51720-734_ca288dcb-03be-4c63-83e1-bb271b6333ca 51720-734 HUMAN OTC DRUG MittiHeal Natural Wound Care Calendula Officinalis, Arnica Montana POWDER TOPICAL 20090815 UNAPPROVED HOMEOPATHIC Curative Power Lab PVT LTD ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP 6; 6 [hp_X]/10g; [hp_X]/10g 51727-0631_92c06df6-f2e8-458a-b19f-5dd28daa52e4 51727-0631 HUMAN OTC DRUG Urban Defense Octocrylene and Octinoxate EMULSION TOPICAL 20120716 OTC MONOGRAPH FINAL part352 Urban Decay Cosmetics, LLC OCTINOXATE; OCTOCRYLENE 3.75; 4 mL/50mL; mL/50mL 51727-0632_92c06df6-f2e8-458a-b19f-5dd28daa52e4 51727-0632 HUMAN OTC DRUG Urban Defense Octocrylene and Octinoxate EMULSION TOPICAL 20120716 OTC MONOGRAPH FINAL part352 Urban Decay Cosmetics, LLC OCTINOXATE; OCTOCRYLENE 3.75; 4 mL/50mL; mL/50mL 51727-0633_92c06df6-f2e8-458a-b19f-5dd28daa52e4 51727-0633 HUMAN OTC DRUG Urban Defense Octocrylene and Octinoxate EMULSION TOPICAL 20120716 OTC MONOGRAPH FINAL part352 Urban Decay Cosmetics, LLC OCTINOXATE; OCTOCRYLENE 3.75; 4 mL/50mL; mL/50mL 51727-0634_92c06df6-f2e8-458a-b19f-5dd28daa52e4 51727-0634 HUMAN OTC DRUG Urban Defense Octocrylene and Octinoxate EMULSION TOPICAL 20120716 OTC MONOGRAPH FINAL part352 Urban Decay Cosmetics, LLC OCTINOXATE; OCTOCRYLENE 3.75; 4 mL/50mL; mL/50mL 51730-0001_e1e2da7c-2d2c-4a57-bc07-e5e5830b6b9d 51730-0001 HUMAN OTC DRUG Lymph Rx Ceanothus Americanus, Euphrasia Officinalis, Geranium Robertianum, Juglans Regia, Myosotis Arvensis, Sarsaparilla LIQUID ORAL 20130313 UNAPPROVED HOMEOPATHIC Health and Harmony Products ALTHAEA OFFICINALIS ROOT; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; CEANOTHUS AMERICANUS LEAF; ECHINACEA ANGUSTIFOLIA; EQUISETUM HYEMALE; EUPHRASIA STRICTA; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MERCURIC CYANIDE; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; PEUMUS BOLDUS LEAF; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM IODIDE; SCROPHULARIA NODOSA; SMILAX REGELII ROOT; SODIUM SULFATE; SUS SCROFA PARATHYROID GLAND; SUS SCROFA THYMUS; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAF; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP; VISCUM ALBUM FRUITING TOP 1; 4; 12; 8; 8; 1; 3; 1; 1; 4; 1; 8; 1; 1; 1; 1; 1; 8; 1; 3; 1; 3; 1; 1; 1; 1; 4; 12; 12; 12; 1; 1; 8; 4; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 51730-0002_f3f396f1-1b13-491d-adb6-642430730142 51730-0002 HUMAN OTC DRUG Lymph Care Ceanothus Americanus, Euphrasia Officinalis, Geranium Robertianum, Juglans Regia, Myosotis Arvensis, Sarsaparilla, Scrophularia Nodosa LIQUID ORAL 20130814 UNAPPROVED HOMEOPATHIC Health and Harmony Products ALTHAEA OFFICINALIS ROOT; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; BOS TAURUS PARATHYROID GLAND; BOS TAURUS THYMUS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; CEANOTHUS AMERICANUS LEAF; ECHINACEA, UNSPECIFIED; EQUISETUM HYEMALE; EUPHRASIA STRICTA; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MERCURIC CYANIDE; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; PEUMUS BOLDUS LEAF; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM IODIDE; SARSAPARILLA; SCROPHULARIA NODOSA; SODIUM SULFATE; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAF; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP; VISCUM ALBUM FRUITING TOP 1; 4; 12; 8; 12; 12; 8; 1; 3; 1; 1; 4; 1; 8; 1; 1; 1; 1; 1; 8; 1; 3; 1; 3; 1; 1; 1; 1; 4; 12; 1; 1; 8; 4; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 51754-0500_f423a220-e7bf-4d24-bc52-bafc1864265b 51754-0500 HUMAN PRESCRIPTION DRUG caffeine citrate caffeine citrate INJECTION INTRAVENOUS 20060921 ANDA ANDA077233 Exela Pharma Sciences, LLC CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 51758-003_c4aa9587-bddb-4243-b765-c4d17966e6d4 51758-003 HUMAN PRESCRIPTION DRUG Nitrogen c70f6047-a0cb-4f70-aa3a-78acd681efc3 Nitrogen LIQUID RESPIRATORY (INHALATION) 20080901 UNAPPROVED MEDICAL GAS Gases Plus Norco, LLC NITROGEN 999 L/1000L 51758-004_745fc2f4-c030-453d-bec0-dbff153a80cb 51758-004 HUMAN PRESCRIPTION DRUG Oxygen 4c21e554-d402-480d-896d-8185c05c7863 Oxygen LIQUID RESPIRATORY (INHALATION) 20080901 UNAPPROVED MEDICAL GAS Gases Plus Norco, LLC OXYGEN 999 L/1000L 51759-101_7c0e5740-3fd7-11e3-aa6e-0800200c9a66 51759-101 HUMAN PRESCRIPTION DRUG ZECUITY sumatriptan succinate PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED TRANSDERMAL 20131001 NDA NDA202278 NuPathe Inc. SUMATRIPTAN SUCCINATE 6.5 mg/4h Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 51760-001_b95ab4fc-2de4-498d-801e-3b5029e455bc 51760-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F18 INJECTION INTRAVENOUS 20050819 ANDA ANDA203946 Essential Isotopes LLC FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 51760-002_5f498ddd-b133-437f-94c1-1b574f022645 51760-002 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F-18 INJECTION INTRAVENOUS 20110101 ANDA ANDA204541 Essential Isotopes LLC SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 51769-002_f417a71f-7351-40f1-ac5a-05536bb745ba 51769-002 HUMAN OTC DRUG TING Athetes foot Undecylenic acid, Triclosan CREAM CUTANEOUS 20130109 OTC MONOGRAPH FINAL part333C ALL NATURAL DYNAMICS TRICLOSAN; UNDECYLENIC ACID .1; 3.78 g/100g; g/100g 51769-003_050c22b8-dc2f-414c-a4ad-13468bd28728 51769-003 HUMAN OTC DRUG TING Cream Undecylenic acid, Triclosan CREAM CUTANEOUS 20130315 OTC MONOGRAPH FINAL part333C ALL NATURAL DYNAMICS TRICLOSAN; UNDECYLENIC ACID .1; 3.78 g/100g; g/100g 51769-105_ed663d70-2279-4e16-98fe-152c6da4e253 51769-105 HUMAN OTC DRUG OBAO Soft Freshness ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130902 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g 51769-107_c94e1ee6-fe8a-415f-b13f-b4fe91258e54 51769-107 HUMAN OTC DRUG Obao Bamboo Breeze Aluminum Chlorohydrate STICK TOPICAL 20130301 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g 51769-123_48767cdd-c72a-45a0-a69e-c89a3a1c3213 51769-123 HUMAN OTC DRUG Obao Floral Freshness ALUMINUM CHLOROHYDRATE STICK TOPICAL 20130312 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g 51769-124_f4b42768-3a6d-464a-92b5-94d7a57a2e06 51769-124 HUMAN OTC DRUG antiperspirant deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100331 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g 51769-125_eda0e98f-2879-4334-8c9b-fb338e4a4fdb 51769-125 HUMAN OTC DRUG Obao Cool Metal Aluminum Chlorohydrate STICK TOPICAL 20130301 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g 51769-127_572e8cfb-376f-4588-afbf-0a3cbcc694a5 51769-127 HUMAN OTC DRUG Obao Active ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100331 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g 51769-133_6c83ea07-49b7-4448-ba47-bc80062868f6 51769-133 HUMAN OTC DRUG Head and Shoulders menthol fresh Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130124 OTC MONOGRAPH FINAL part358H ALL NATURAL DYNAMICS PYRITHIONE ZINC .01 g/mL 51769-134_8a5d9da2-91e2-4b94-8bfa-384ef298217e 51769-134 HUMAN OTC DRUG Head and Shoulders menthol fresh Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130124 OTC MONOGRAPH FINAL part358H ALL NATURAL DYNAMICS PYRITHIONE ZINC .01 g/mL 51769-139_bee61e39-5dbe-4dc0-b6bd-d753fe128346 51769-139 HUMAN OTC DRUG Head and Shoulders renewing clean Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130129 OTC MONOGRAPH FINAL part358H ALL NATURAL DYNAMICS PYRITHIONE ZINC .01 g/mL 51769-140_e99160c9-87f4-4ca9-9765-0cef60308776 51769-140 HUMAN OTC DRUG Head and Shoulders hair loss prevention Pyrithione Zinc SHAMPOO TOPICAL 20130201 OTC MONOGRAPH FINAL part358H ALL NATURAL DYNAMICS PYRITHIONE ZINC .01 g/mL 51769-141_f58016ec-c5ab-4943-bd2b-e85b04fac313 51769-141 HUMAN OTC DRUG Head and Shoulders breakage prevention Pyrithione Zinc SHAMPOO TOPICAL 20130201 OTC MONOGRAPH FINAL part358H ALL NATURAL DYNAMICS PYRITHIONE ZINC .01 g/mL 51769-411_8b520486-b7e9-4074-b666-5e5614068bf8 51769-411 HUMAN OTC DRUG Obao Sensitive Passion Aluminum Chlorohydrate STICK TOPICAL 20130301 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g 51769-412_e341a078-48af-41ea-9997-869f72bdaebb 51769-412 HUMAN OTC DRUG Obao Sensitive Passion Aluminum Chlorohydrate STICK TOPICAL 20130301 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g 51769-555_4b816b38-e0dc-4ef5-ae2d-837ab9173a8e 51769-555 HUMAN OTC DRUG MUM CHAMOMILE Aluminum Chlorohydrate STICK TOPICAL 20130301 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g 51769-614_a01e67cc-29df-415d-b742-a6ca74b63604 51769-614 HUMAN OTC DRUG Clarant B3 Avobenzone Octinoxate CREAM TOPICAL 20140704 OTC MONOGRAPH NOT FINAL part352 ALL NATURAL DYNAMICS AVOBENZONE; OCTINOXATE 2800; 7100 mg/100g; mg/100g 51769-615_22a06b2d-dda0-49ed-b729-b22715f8ff17 51769-615 HUMAN OTC DRUG PONDS clarant b3 Anti-Dark Moisturizing Cream CREAM TOPICAL 20120629 OTC MONOGRAPH FINAL part352 ALL NATURAL DYNAMICS AVOBENZONE 3 g/100g 51769-666_4311bbeb-fece-4b8e-80a9-292e0a91befc 51769-666 HUMAN OTC DRUG Lady Speed Stick Aluminum Chlorohydrate STICK TOPICAL 20130301 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g 51769-888_ffb56df0-1f94-4f1f-8703-ffd2cc905587 51769-888 HUMAN OTC DRUG Obao Men Audaz Aluminum Chlorohydrate LIQUID TOPICAL 20130823 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g 51769-890_0e7fbffb-5081-4335-8d84-e3c9b03f1742 51769-890 HUMAN OTC DRUG PONDS VAO-B3 AVOBENZONE CREAM TOPICAL 20130902 OTC MONOGRAPH FINAL part352 ALL NATURAL DYNAMICS AVOBENZONE 3 g/100g 51769-901_9f63604f-8dae-449c-87eb-a2ba10617f14 51769-901 HUMAN OTC DRUG Head and Shoulders smooth and silky Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130124 OTC MONOGRAPH FINAL part358H ALL NATURAL DYNAMICS PYRITHIONE ZINC .01 g/mL 51769-980_61d9c594-134a-4112-a985-09d075498cf0 51769-980 HUMAN OTC DRUG STEFANO Fire ALUMINUM CHLOROHYDRATE STICK TOPICAL 20120517 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 25 g/100mL 51770-001_15f4b372-3274-4abb-9a22-89e441d6409f 51770-001 HUMAN OTC DRUG Truth Revealed super creme SPF 15 Ole Henriksen Octinoxate, Avobenzone, Oxybenzone, Octocrylene CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ole Henriksen AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 2; 7.5; 1.9; 2 g/100g; g/100g; g/100g; g/100g 51770-110_4c548ab4-9bee-4e93-8af2-9b35bab3ec87 51770-110 HUMAN OTC DRUG perfect truth cc eye broad spectrum SPF 15 OleHenriksen Avobenzone, Homosalate, Octocrylene CREAM TOPICAL 20130327 OTC MONOGRAPH NOT FINAL part352 Ole Henriksen AVOBENZONE; HOMOSALATE; OCTOCRYLENE 2; 5; 1.86 g/100mL; g/100mL; g/100mL 51770-111_2b099a6e-ac88-4b0a-ae7a-c89cb5cca368 51770-111 HUMAN OTC DRUG Perfect Truth cc Broad Spectrum SPF 30 Ole Henriksen Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20130327 OTC MONOGRAPH NOT FINAL part352 Ole Henriksen AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 5; 7.5; 5; 1.86 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 51770-112_19871cae-b72b-49a9-a6bd-f4ad74a5b762 51770-112 HUMAN OTC DRUG perfect truth cc broad spectrum SPF 30 sunscreen Ole Henriksen Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Ole Henriksen AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 5; 7.5; 5; 1.86 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 51770-154_ec107a68-23c3-4d5d-b348-5d7218f16340 51770-154 HUMAN OTC DRUG Total Truth Eye Creme SPF 15 Ole Henriksen AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20110314 OTC MONOGRAPH NOT FINAL part352 Ole Henriksen of Denmark AVOBENZONE; OCTINOXATE; OCTISALATE 2; 4; 4 g/100g; g/100g; g/100g 51770-222_7fde4113-6e12-4ff8-80ce-a4adee12188c 51770-222 HUMAN OTC DRUG Protect The Truth SPF 50 Ole Henriksen AVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE,OXYBENZONE LOTION TOPICAL 20110315 OTC MONOGRAPH NOT FINAL part352 Ole Henriksen of Denmark AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.7; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 51772-311_ec21fe5a-b1f8-405e-9d75-6c01a24c9e51 51772-311 HUMAN PRESCRIPTION DRUG LAZANDA Fentanyl Citrate SPRAY NASAL 20111017 NDA NDA022569 Archimedes Pharma US Inc. FENTANYL CITRATE 100 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 51772-314_ec21fe5a-b1f8-405e-9d75-6c01a24c9e51 51772-314 HUMAN PRESCRIPTION DRUG LAZANDA Fentanyl Citrate SPRAY NASAL 20111017 NDA NDA022569 Archimedes Pharma US Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 51785-086_cf903b2b-fa0b-4f6e-a25c-a0aecdea554b 51785-086 HUMAN OTC DRUG Skin Activator Day SPF 15 Octinoxate, Octisalate and Avobenzone LOTION TOPICAL 20111021 OTC MONOGRAPH NOT FINAL part352 Herbalife International of America, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE .0198; .0742; .0495 g/mL; g/mL; g/mL 51785-424_1165dc32-45bd-4484-aaf6-c06c1854028c 51785-424 HUMAN OTC DRUG Hand Sanitizer BENZALKONIUM CHLORIDE SPRAY TOPICAL 20120829 OTC MONOGRAPH NOT FINAL part333A Herbalife International of America Inc. BENZALKONIUM CHLORIDE .0294 g/30mL 51785-445_7b1f6ff8-4597-4439-bf6a-328ff60690b6 51785-445 HUMAN OTC DRUG Radiant C UVA/UVB Sunscreen Avobenzone, Octinoxate, and Oxybenzone LOTION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Herbalife International of America AVOBENZONE; OCTINOXATE; OXYBENZONE .03; .07; .004 g/mL; g/mL; g/mL 51785-455_ac2c84fe-162e-4e88-a2b0-fbad00f0e73b 51785-455 HUMAN OTC DRUG Herbalife SKIN 7 Day Results Kit Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone KIT 20140701 OTC MONOGRAPH FINAL part352 Herbalife International of America Inc. 51785-514_27f10d63-0a3a-48c5-84ba-d450458faa0d 51785-514 HUMAN OTC DRUG NouriFusion Avobenzone, Octinoxate, Octisalate LOTION TOPICAL 20120925 OTC MONOGRAPH NOT FINAL part352 Herbalife International of America Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 1.079; 3.535; 1.52 g/50mL; g/50mL; g/50mL 51785-515_c629741e-f900-4ad1-aef3-03f99b5e6817 51785-515 HUMAN OTC DRUG NouriFusion Avobenzone, Octinoxate, Octisalate LOTION TOPICAL 20120925 OTC MONOGRAPH NOT FINAL part352 Herbalife International of America Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 1.079; 3.535; 1.52 g/50mL; g/50mL; g/50mL 51785-866_8a7cb722-73f9-4bbd-9e8c-7af0a0993738 51785-866 HUMAN OTC DRUG Skin Activator Lip Refiner SPF 15 Octinoxate, Octisalate and Avobenzone LOTION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Herbalife International of America AVOBENZONE; OCTINOXATE; OCTISALATE .0142; .0661; .0472 g/mL; g/mL; g/mL 51785-899_d9d3b2a3-8400-4ecd-b68b-5d019f3dad96 51785-899 HUMAN OTC DRUG Herbalife Skin Protective Moisturizer SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20140701 OTC MONOGRAPH FINAL part352 Herbalife International of America Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .9711; 1.56; 1.515; .8505; 1.8 g/30mL; g/30mL; g/30mL; g/30mL; g/30mL 51785-921_e672b348-5bef-41c1-9f53-9bcf50316104 51785-921 HUMAN OTC DRUG Herbal Aloe Face and Body SPF 30 Avobenzone. Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20140825 OTC MONOGRAPH FINAL part352 Herbalife International of America Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.8844; 6.24; 6.06; 3.4; 7.2 g/mL; g/mL; g/mL; g/mL; g/mL 51791-001_9e77defa-9329-4187-bd32-84b7ed8ec0d6 51791-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19820101 UNAPPROVED MEDICAL GAS Eastern Welding Supply, Inc OXYGEN 99 L/100L 51801-001_63ede6be-645a-4386-a575-47a4d5469a54 51801-001 HUMAN PRESCRIPTION DRUG Effer-K Orange POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130130 UNAPPROVED DRUG OTHER Nomax Inc. POTASSIUM BICARBONATE 977.5 mg/1 51801-003_4fa258b9-db62-43ff-a941-7f5632b17ffe 51801-003 HUMAN PRESCRIPTION DRUG GloStrips Fluorescein Sodium STRIP OPHTHALMIC 20130730 UNAPPROVED DRUG OTHER Nomax Inc. FLUORESCEIN SODIUM .6 mg/1 Diagnostic Dye [EPC],Dyes [MoA] 51801-004_f3985299-bba9-495a-ba21-87c59bf1db66 51801-004 HUMAN PRESCRIPTION DRUG GloStrips Rose Bengal Sodium STRIP OPHTHALMIC 20130820 UNAPPROVED DRUG OTHER Nomax Inc. ROSE BENGAL SODIUM 1.3 mg/1 51801-005_63ede6be-645a-4386-a575-47a4d5469a54 51801-005 HUMAN PRESCRIPTION DRUG Effer-K Lemon Citrus POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130130 UNAPPROVED DRUG OTHER Nomax Inc. POTASSIUM BICARBONATE 977.5 mg/1 51801-006_63ede6be-645a-4386-a575-47a4d5469a54 51801-006 HUMAN PRESCRIPTION DRUG Effer-K Cherry Berry POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130130 UNAPPROVED DRUG OTHER Nomax Inc. POTASSIUM BICARBONATE 977.5 mg/1 51801-007_63ede6be-645a-4386-a575-47a4d5469a54 51801-007 HUMAN PRESCRIPTION DRUG Effer-K Unflavored POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130130 UNAPPROVED DRUG OTHER Nomax Inc. POTASSIUM BICARBONATE 977.5 mg/1 51801-008_08dd04c1-ca76-4b5d-ae29-1479238743b2 51801-008 HUMAN PRESCRIPTION DRUG Dry Eye Test Fluorescein Sodium STRIP OPHTHALMIC 20131205 UNAPPROVED DRUG OTHER Nomax Inc. FLUORESCEIN SODIUM .12 mg/1 Diagnostic Dye [EPC],Dyes [MoA] 51801-009_3ed3e55d-c387-4bdc-b406-aa413a73d73a 51801-009 HUMAN PRESCRIPTION DRUG GloStrips Fluorescein Sodium STRIP OPHTHALMIC 20130730 UNAPPROVED DRUG OTHER Nomax Inc. FLUORESCEIN SODIUM 1 mg/1 Diagnostic Dye [EPC],Dyes [MoA] 51801-011_5fe7d30f-2394-4fcc-b41d-198812ef4e6b 51801-011 HUMAN PRESCRIPTION DRUG Effer-K 20 mEq Unflavored POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130130 UNAPPROVED DRUG OTHER Nomax Inc. POTASSIUM BICARBONATE 782 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 51801-012_5fe7d30f-2394-4fcc-b41d-198812ef4e6b 51801-012 HUMAN PRESCRIPTION DRUG Effer-K 20 mEq Orange Cream POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130130 UNAPPROVED DRUG OTHER Nomax Inc. POTASSIUM BICARBONATE 782 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 51801-013_5fe7d30f-2394-4fcc-b41d-198812ef4e6b 51801-013 HUMAN PRESCRIPTION DRUG Effer-K 10 mEq Unflavored POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130130 UNAPPROVED DRUG OTHER Nomax Inc. POTASSIUM BICARBONATE 391 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 51801-014_5fe7d30f-2394-4fcc-b41d-198812ef4e6b 51801-014 HUMAN PRESCRIPTION DRUG Effer-K 10 mEq Cherry Vanilla POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130130 UNAPPROVED DRUG OTHER Nomax Inc. POTASSIUM BICARBONATE 391 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 51803-001_43555ea1-944f-4371-a9e5-6c98316ce6d2 51803-001 HUMAN OTC DRUG IOSAT Potassium Iodide TABLET ORAL 19821014 NDA NDA018664 Anbex Inc. POTASSIUM IODIDE 130 mg/1 51803-002_77ccaf76-1fc9-49fb-a163-49b080c91c33 51803-002 HUMAN OTC DRUG IOSAT Potassium Iodide TABLET ORAL 20130501 NDA NDA018664 Anbex Inc. POTASSIUM IODIDE 65 mg/1 51808-101_40ecc37d-84df-4f1c-ab4b-30d0c06718a2 51808-101 HUMAN PRESCRIPTION DRUG Sodium Chromate 51 Sodium Chromate 51 SOLUTION INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation CHROMIUM CR-51 1 mCi/5mL 51808-102_130c71b9-1a33-45b2-ab19-e38b6ee0ee68 51808-102 HUMAN PRESCRIPTION DRUG I 123 Mini I 123 Mini CAPSULE ORAL 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation IODIDE ION I-123 10 mCi/1 Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 51808-103_ea9f7125-98b5-49c3-85b8-763915156ff0 51808-103 HUMAN PRESCRIPTION DRUG i 123 MIBG meta iodobenzylguanidine i 123 MIBG INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation IOBENGUANE SULFATE I-123 25 mCi/1 51808-119_5811e231-e65f-4771-9875-7d8f6197473f 51808-119 HUMAN PRESCRIPTION DRUG I 131 Mini I 131 Mini CAPSULE ORAL 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation SODIUM IODIDE I-131 500 mCi/1 51808-125_0e714ae6-396c-4488-868e-bfe5fd446f3f 51808-125 HUMAN PRESCRIPTION DRUG In-111 DTPA In-111 DTPA SOLUTION INTRATHECAL 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation INDIUM IN-111 PENTETATE DISODIUM 3.75 mCi/1.5mL Lead Chelating Activity [MoA],Lead Chelator [EPC] 51808-126_b16e5845-c429-4530-969b-a7cbabe43116 51808-126 HUMAN PRESCRIPTION DRUG Indium 111 Oxyquinolone Indium 111 Oxyquinolone SOLUTION INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation INDIUM IN-111 OXYQUINOLINE 2 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 51808-127_5ed86373-1e27-42fc-a3b3-b198944f0dff 51808-127 HUMAN PRESCRIPTION DRUG P32 Sodium Phosphate P32 Sodium Phosphate INJECTION, SUSPENSION INTERSTITIAL; INTRA-ARTICULAR; INTRAPERITONEAL; INTRAPLEURAL 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation PHOSPHORUS P-32 5 mCi/mL 51808-128_c099d1ae-d9f6-4176-b55c-233ce52b2976 51808-128 HUMAN PRESCRIPTION DRUG P32 Sodium Phosphate P32 Sodium Phosphate SOLUTION INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation PHOSPHORUS P-32 10 mCi/4mL 51808-201_651af678-d1d2-4e8e-8fe0-ae6c0ba11a16 51808-201 HUMAN PRESCRIPTION DRUG ACD Solution Modified ACD Solution Modified SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation ANHYDROUS CITRIC ACID 8 mg/mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 51808-203_8f9023fb-e982-440a-a9ee-374c4bf3153b 51808-203 HUMAN PRESCRIPTION DRUG SIncalide Sincalide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation SINCALIDE 3 ug/1 Cholecystokinin [Chemical/Ingredient],Cholecystokinin Analog [EPC] 51808-204_71f96ee3-a363-4345-9ab6-5270ae323fab 51808-204 HUMAN PRESCRIPTION DRUG Dipyridamole Dipridamole SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation DIPYRIDAMOLE 5 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 51808-206_25e39c45-5f86-400f-beab-63f773e54734 51808-206 HUMAN PRESCRIPTION DRUG Isosulfan Blue Isosulfan Blue SOLUTION SUBCUTANEOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation ISOSULFAN BLUE 10 mg/mL 51808-207_9292f201-2136-4da5-9d6f-0d7daca2de1e 51808-207 HUMAN PRESCRIPTION DRUG Pentagastrin Pentagastrin SOLUTION INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation PENTAGASTRIN 250 ug/1.6mL 51808-208_118e6927-25b5-4bcc-8716-fcb5dbdc487b 51808-208 HUMAN PRESCRIPTION DRUG Sestamibi Sestamibi INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1.5 mg/1 51808-209_ad867c7e-d1fa-4587-9c3e-26a40fcf0ccc 51808-209 HUMAN PRESCRIPTION DRUG Thyrotropin Releasing Hormone TRH Thyrotropin Releasing Hormone SOLUTION INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation PROTIRELIN 500 ug/mL 51808-210_29c1fd45-7d77-4882-9e73-8a66742be742 51808-210 HUMAN PRESCRIPTION DRUG Dextran 75 Dextran 75 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120701 UNAPPROVED DRUG OTHER AnazaoHealth Corporation DEXTRAN 75 10 mg/1 Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA] 51808-211_ec657ecb-6327-464c-8aab-6d61a0546b83 51808-211 HUMAN PRESCRIPTION DRUG Dimercaptosuccinic Acid DMSA Dimercaptosuccinic Acid INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120701 UNAPPROVED DRUG OTHER AnazaoHealth Corporation 2,3-DIMERCAPTOSUCCINIC ACID 1.1 mg/1 51808-213_fb2f24ff-01b1-4afe-9a24-dfa98fa1f047 51808-213 HUMAN PRESCRIPTION DRUG Glucoheptonate Glucoheptonate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation CALCIUM GLUCEPTATE 50 mg/1 51808-214_dd2d8053-37a4-465d-9086-2bd084c4898c 51808-214 HUMAN PRESCRIPTION DRUG Exametazime HMPAO Exametazime INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120701 UNAPPROVED DRUG OTHER AnazaoHealth Corporation EXAMETAZIME 1 mg/1 51808-216_4d7406b4-8bcd-40f0-a31f-975f5b811da7 51808-216 HUMAN PRESCRIPTION DRUG Mebrofenin Mebrofenin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation MEBROFENIN 10 mg/1 51808-217_b780bd14-67f7-4dd6-8d36-f53a6d38152c 51808-217 HUMAN PRESCRIPTION DRUG Bicisate Bicisate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation BICISATE 1.35 mg/1 51808-218_e247d821-b132-4a87-a71a-8bc13c71fcfc 51808-218 HUMAN PRESCRIPTION DRUG Pyrophosphate Pyrophosphate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation SODIUM PYROPHOSPHATE 27.6 mg/1 51808-220_7c1f657a-07f0-4f9f-9552-1688174e2130 51808-220 HUMAN PRESCRIPTION DRUG Sulfur Colloid Sulfur Colloid INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120701 UNAPPROVED DRUG OTHER AnazaoHealth Corporation GELATIN 4.5 mg/1 51808-223_0edc9a01-f669-4e7c-af14-cee9bfb3daa3 51808-223 HUMAN PRESCRIPTION DRUG Tetrofosmin Tetrofosmin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation TETROFOSMIN .35 mg/1 51808-223_89513168-46fb-471f-9566-e2240cedfa84 51808-223 HUMAN PRESCRIPTION DRUG Tetrofosmin Tetrofosmin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation TETROFOSMIN .35 mg/1 51811-065_3a1c7b69-5635-4bf7-a6c7-32ebfb061507 51811-065 HUMAN OTC DRUG Hydrating Instant Hand Sanitizer Alcohol GEL TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part333E HANOVER PEN CORP dba HPC Global ALCOHOL 10.35 mL/14.78mL 51811-066_661845fe-fe56-4fd3-9bae-5283e25c7274 51811-066 HUMAN OTC DRUG Antibacterial Protective Hand Chlorhexidine Gluconate LOTION TOPICAL 20130201 UNAPPROVED DRUG OTHER Hanover Pen Corp dba HPC Global CHLORHEXIDINE GLUCONATE .07075 g/14.15g 51811-352_826396f4-8e7d-4ddc-bc2b-48603219d349 51811-352 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol SPRAY TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 5.58 mL/9mL 51811-352_f7f154f9-107c-4078-9daa-38117165b413 51811-352 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol SPRAY TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 5.58 mL/9mL 51811-353_8b4ad367-b6fb-45fa-8b6f-d80a9dcba35b 51811-353 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol SPRAY TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 2.79 mL/4.5mL 51811-353_92e04d25-9124-4be0-8ebf-cffd62c1ff34 51811-353 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol SPRAY TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 2.79 mL/4.5mL 51811-362_d7657ce7-76d6-430b-ae15-dd0f7b6c5d2d 51811-362 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol GEL TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 19.66 mL/29.57mL 51811-362_e8b2eb0f-020e-4e4e-bca9-4d78dd0d52cb 51811-362 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol GEL TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 19.66 mL/29.57mL 51811-363_34e29508-e76f-43ea-9885-427e579fcd0b 51811-363 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol GEL TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 39.33 mL/59.14mL 51811-363_6b691ec6-f50e-4622-813f-3c55222f67a4 51811-363 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol GEL TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 39.33 mL/59.14mL 51811-368_80a05c50-5626-4ab5-af43-c3f667b7e046 51811-368 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol GEL TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 19.66 mL/29.57mL 51811-368_8d0100e9-ae0d-4961-8a64-9c77844b286b 51811-368 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol GEL TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 19.66 mL/29.57mL 51811-374_88e2dfa9-05e6-4130-84b2-2c5784105199 51811-374 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL .665 g/mL 51811-374_d133f9ab-cb6d-4d54-9912-8ec1fbf2becc 51811-374 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL .665 g/mL 51811-375_6a816ac1-9280-4d8f-a9d0-868c5e5a283f 51811-375 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL .665 g/mL 51811-375_86d17974-2f96-43b3-893b-7e922f825bea 51811-375 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL .665 g/mL 51811-376_3c61da8b-2dc6-43eb-97b3-96983d1458bc 51811-376 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL .665 g/mL 51811-376_5cd2190d-dccf-4c5d-9a91-5b221e9a6724 51811-376 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL .665 g/mL 51811-377_8821ed7c-0e44-46d6-8c78-da40471eb4dc 51811-377 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL .665 g/mL 51811-377_b1608634-6985-4b7e-9636-68357b78d78a 51811-377 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL .665 g/mL 51811-658_db32639b-8fd0-4078-b3c6-ae9485f7f5f6 51811-658 HUMAN OTC DRUG Antibacterial Protective Hand Chlorhexidine Gluconate LOTION TOPICAL 20130201 UNAPPROVED DRUG OTHER Hanover Pen Corp dba HPC Global CHLORHEXIDINE GLUCONATE .0045 g/.9g 51811-659_e62b853f-85bf-4983-af77-6825dd5e5438 51811-659 HUMAN OTC DRUG Hydrating Instant Hand Sanitizer Alcohol GEL TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part333E HANOVER PEN CORP dba HPC Global ALCOHOL .6329 mL/.9242mL 51812-0001_19a8c1aa-0a21-4945-afde-f5c00b31c677 51812-0001 HUMAN OTC DRUG Rejuvenation HGH Fucus Vesiculosus, Cyanocobalamin, Glandula Suprarenalis Suis, Hepar Suis, Thyroidinum, Pancreatinum LIQUID ORAL 20130220 UNAPPROVED HOMEOPATHIC Degen Health Products CYANOCOBALAMIN; FUCUS VESICULOSUS; PANCRELIPASE; PORK LIVER; SOMATROPIN; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID 6; 2; 12; 6; 30; 6; 18; 30; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 51815-208_e25e264d-dd26-4fb4-8e4c-ecef82db92d1 51815-208 HUMAN OTC DRUG Right Guard Sport Active Aluminum Zirconium Trichlorohydrex GLY STICK TOPICAL 20121201 OTC MONOGRAPH FINAL part350 VVF Illinois Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 7.14 g/51g 51815-209_3242fa6d-53bb-4c28-b939-e87d35e766d9 51815-209 HUMAN OTC DRUG Right Guard Sport Fresh Aluminum Zirconium Octachlorhydrex GLY GEL TOPICAL 20140320 OTC MONOGRAPH FINAL part350 VVF Illinois Services ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 13.94 1/85g 51815-213_ac43282a-0b2c-47cc-9905-cda4c10345e1 51815-213 HUMAN OTC DRUG Right Guard Xtreme Clear Clean Aluminum Zirconium Tetrachlorohydrex STICK TOPICAL 20130101 OTC MONOGRAPH FINAL part350 VVF Illinois Services LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g 51815-214_410ce7e4-47dc-432c-9dab-ab898f20e7f6 51815-214 HUMAN OTC DRUG Right Guard Total Defense 5 Arctic Refresh Aluminum Zirconium Octachlorhydrex GLY GEL TOPICAL 20140101 OTC MONOGRAPH FINAL part350 VVF Illinois Services LLC ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 18.5 g/113g 51815-215_652dfa90-dbbd-4f88-a398-268911d6e024 51815-215 HUMAN OTC DRUG Right Guard Xtreme Clear Fresh Aluminum Zirconium Tetrachlorohydrex STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 VVF Illinois Services LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g 51815-216_ddb3d3a5-d298-40da-8b35-edcd9d529efe 51815-216 HUMAN OTC DRUG Right Guard Clinical Clear Clean Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 VVF Illinois Services ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 48 g/48g 51815-217_2df64b8e-0eb3-44a3-a6b5-a0b6ba83dcfe 51815-217 HUMAN OTC DRUG Soft and Dri Dri Gel Soft Scent Aluminum Zirconium Octochlorohydrex STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 VVF Illinois Services ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 85 g/85g 51815-218_e9cbe397-f95e-4ea8-b5e0-e7d0746a8a6c 51815-218 HUMAN OTC DRUG Dry Idea Advanced Dry Fresh Aluminum Zirconium Octachlorohydrex GLY STICK TOPICAL 20140317 OTC MONOGRAPH FINAL part350 VVF Illinois Services LLC ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 13.94 g/85g 51815-223_3f95245d-c839-4bf4-b540-c631aaa44b74 51815-223 HUMAN OTC DRUG Dry Idea Clinical Clear Clean Aluminum Zirconium Tetrachlorohydrex GLY 20.0% STICK TOPICAL 20140402 OTC MONOGRAPH FINAL part350 VVF Illinois Services ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 9.6 g/48g 51815-224_61b50bc0-be16-45ac-be65-4faba15483da 51815-224 HUMAN OTC DRUG Dry Idea Clean Aluminum Zirconium Tetrachlorohydrex GLY 19.0% STICK TOPICAL 20140204 OTC MONOGRAPH FINAL part350 VVF Illinois Services ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g 51815-225_8f4ce4e3-a987-4a51-b5bd-e3bece84d12c 51815-225 HUMAN OTC DRUG Right Guard Sport Triathlon Aluminum Zirconium Octachlorhydrex GLY STICK TOPICAL 20140320 OTC MONOGRAPH FINAL part350 VVF Illinois Services ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 7.14 g/51g 51815-300_596f3643-c3d6-4af6-aec7-9cfd100f813c 51815-300 HUMAN OTC DRUG Dial antibacterial Triclocarban SOAP TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part333E VVF Illinois Services LLC TRICLOCARBAN .339 g/113g 51815-301_f28bbeeb-7ebe-4c82-961f-e91f1d6b7a27 51815-301 HUMAN OTC DRUG Dial White Triclocarban SOAP TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part333E VVF Illinois Services LLC TRICLOCARBAN 113 g/113g 51815-302_ff539acc-6c86-4693-b3f3-4b70cde7404a 51815-302 HUMAN OTC DRUG Dial Aloe Aloe Triclocarban SOAP TOPICAL 20140527 OTC MONOGRAPH NOT FINAL part333E VVF Illinois Services LLC TRICLOCARBAN 1.017 g/339g 51815-303_299aadee-e95d-4d3a-9e49-904f16e18fd2 51815-303 HUMAN OTC DRUG Dial Odor Armor Odor Armor Triclocarban SOAP TOPICAL 20140527 OTC MONOGRAPH NOT FINAL part333E VVF Illinois Services LLC TRICLOCARBAN 1.017 g/339g 51815-307_dab74e14-b673-46b3-a492-2a858096dc2c 51815-307 HUMAN OTC DRUG Dial Acne Acne Triclocarban SOAP TOPICAL 20140527 OTC MONOGRAPH FINAL part333D VVF Illinois Services LLC SALICYLIC ACID 4.8 g/240g 51823-3574_db176641-37de-4f06-aab3-69e84a6b1a0b 51823-3574 HUMAN OTC DRUG JiDeSheng Clotrimazole GEL TOPICAL 20101023 OTC MONOGRAPH FINAL part333C UPC Medical Supplies, Inc. CLOTRIMAZOLE 1 g/100g 51824-001_7c9994c6-9f31-4c97-8e90-4ce8900f2dc5 51824-001 HUMAN OTC DRUG CAREALL Tolnaftate Tolnaftate CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part333C New World Imports, Inc TOLNAFTATE 10 mg/g 51824-002_de6c6ffc-6ed8-4276-911f-049b17cd3b68 51824-002 HUMAN OTC DRUG CAREALL Hydrocortisone Maximum Strength Hydrocortisone Acetate CREAM TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part348 New World Imports, Inc HYDROCORTISONE ACETATE 10 mg/g 51824-003_321edf05-d64b-436d-b492-ca4eb22439a4 51824-003 HUMAN OTC DRUG CAREALL Bacitracin Bacitracin Zinc CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part333B New World Imports, Inc BACITRACIN ZINC 500 [iU]/g 51824-004_b1d6122a-6ad3-4f5e-901a-642ef2ec088e 51824-004 HUMAN OTC DRUG NWI LUBRICATING DEXTRAN 70 AND HYDROXYPROPYL METHYLCELLULOSE SOLUTION OPHTHALMIC 20110110 OTC MONOGRAPH FINAL part349 NEW WORLD IMPORTS, INC. DEXTRAN 70; HYPROMELLOSE 2910 (15000 MPA.S) .001; .003 mL/mL; mL/mL 51824-005_c23cdc69-b8f9-479f-8153-5807d951bb43 51824-005 HUMAN OTC DRUG NWI ORIGINAL TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20110110 OTC MONOGRAPH FINAL part349 NEW WORLD IMPORTS, INC. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 51824-006_4f9f722c-a39a-4073-a399-9c0183648242 51824-006 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate OINTMENT TOPICAL 20120601 OTC MONOGRAPH FINAL part333B New World Imports, Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [iU]/g; mg/g; [iU]/g 51824-007_86507b1d-682b-4f2a-855c-39344ded6f54 51824-007 HUMAN OTC DRUG CAREALL Muscle Rub Ultra Strength Menthol, Methyl Salicylate CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part348 New World Imports, Inc MENTHOL; METHYL SALICYLATE 100; 150 mg/g; mg/g 51824-008_b92b635f-fb16-4c13-95b3-611abeb12b33 51824-008 HUMAN OTC DRUG CAREALL Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part348 New World Imports Inc ZINC OXIDE .2 g/g 51824-009_a962f296-5b31-4f6a-8246-aa25a287430a 51824-009 HUMAN OTC DRUG CAREALL Vitamin A and D Lanolin and Petrolatum OINTMENT TOPICAL 20120601 OTC MONOGRAPH FINAL part347 New World Imports, Inc LANOLIN; PETROLATUM .01; .97 g/g; g/g 51824-010_da490b71-936c-425c-a30d-8e91dca9a92a 51824-010 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20100910 OTC MONOGRAPH NOT FINAL part343 New World Imports, Inc ACETAMINOPHEN 325 mg/1 51824-010_e13b23d5-3d85-4c7d-8654-aaf18cacae71 51824-010 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20100914 OTC MONOGRAPH NOT FINAL part343 New World Imports, Inc ACETAMINOPHEN 325 mg/1 51824-011_bccb27d4-d54a-4eab-8637-641dfd2c5811 51824-011 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20100914 OTC MONOGRAPH NOT FINAL part343 New World Imports, Inc ACETAMINOPHEN 500 mg/1 51824-012_2593b7ee-2058-4dd8-a6e7-70559d102187 51824-012 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET, COATED ORAL 20100914 OTC MONOGRAPH NOT FINAL part343 New World Imports, Inc ACETAMINOPHEN 500 mg/1 51824-014_b85b55c8-17b5-4a3a-b138-7d835de9f75d 51824-014 HUMAN OTC DRUG CAREALL Musle and Joint Menthol GEL TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part348 New World Imports, Inc MENTHOL 25 mg/g 51824-015_e44251b1-d4bd-40e8-96f6-aeaa3a4f170d 51824-015 HUMAN OTC DRUG PM Acetaminophen Diphenhydramine, Acetaminophen TABLET ORAL 20100930 OTC MONOGRAPH FINAL part343 New World Imports, Inc ACETAMINOPHEN; DIPHENHYDRAMINE 500; 25 mg/1; mg/1 51824-016_07bc516b-3605-49cc-a56a-c7478f61322b 51824-016 HUMAN OTC DRUG PM Acetaminophen Diphenhydramine Hydrochloride, Acetaminophen TABLET ORAL 20111117 OTC MONOGRAPH FINAL part341 New World Imports, Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 51824-017_a42a0f87-7bd0-49eb-bebb-4edb8a2bc52d 51824-017 HUMAN OTC DRUG Non-Aspirin PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20111117 OTC MONOGRAPH NOT FINAL part343 New World Imports, Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 51824-018_cb919c5c-941d-49f6-912e-2b51e64b65e2 51824-018 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20120605 OTC MONOGRAPH NOT FINAL part343 New World Imports IBUPROFEN 200 mg/1 51824-019_d3dfb975-8800-4a9b-8b41-a3a496eab138 51824-019 HUMAN OTC DRUG Fresh Scent Petroleum PETROLATUM JELLY TOPICAL 20120605 OTC MONOGRAPH FINAL part347 New World Imports, Inc PETROLATUM 1 g/g 51824-020_77f85747-e399-4cb5-b359-f0a094017f34 51824-020 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol GEL TOPICAL 20120612 OTC MONOGRAPH NOT FINAL part333A New World Imports, Inc. ALCOHOL 62 mL/100mL 51824-021_8552989f-f353-425f-875d-50e5d947f1e2 51824-021 HUMAN OTC DRUG Freshscent Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20120614 OTC MONOGRAPH NOT FINAL part350 New World Imports, Inc. ALUMINUM CHLOROHYDRATE 10 mg/100mL 51824-022_5f52105b-afea-46c3-8bdf-e17dc4917c1b 51824-022 HUMAN OTC DRUG Freshscent Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20120614 OTC MONOGRAPH NOT FINAL part350 New World Imports, Inc. ALUMINUM CHLOROHYDRATE 10 mg/100mL 51824-023_b552c52d-619d-4742-8a55-7edf21298b8b 51824-023 HUMAN OTC DRUG Freshscent Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE SPRAY TOPICAL 20120614 OTC MONOGRAPH NOT FINAL part350 New World Imports, Inc. ALUMINUM CHLOROHYDRATE 13 mg/100mL 51824-024_dbeeb944-e08b-4699-997a-14b3068b2d08 51824-024 HUMAN OTC DRUG Roll On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20120622 OTC MONOGRAPH FINAL part350 New World Imports ALUMINUM CHLOROHYDRATE 14 mg/100mL 51824-025_081ec99f-eaa0-49ac-9c8d-b22133576912 51824-025 HUMAN OTC DRUG Complete Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20101111 OTC MONOGRAPH FINAL part341 New World Imports, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 51824-026_75d52b1d-b170-446a-afdb-81c1e316384a 51824-026 HUMAN OTC DRUG Senna-S Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20121201 OTC MONOGRAPH NOT FINAL part334 New World Imports, Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 51824-029_ce89055c-2ed0-4756-9074-eb5a1ffac990 51824-029 HUMAN OTC DRUG Freshmint Premium Anticavity Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130101 OTC MONOGRAPH FINAL part355 New World Imports, Inc SODIUM FLUORIDE 2.43 mg/g 51824-030_602a1e31-e33d-43ec-9be5-a46c2a6a82b2 51824-030 HUMAN OTC DRUG CAREALL Naproxen Naproxen Sodium CAPSULE ORAL 20130501 ANDA ANDA090545 New World Imports, Inc. NAPROXEN SODIUM 220 mg/1 51824-031_b6e6fc72-c37b-45cb-b0fa-744988b86492 51824-031 HUMAN OTC DRUG Freshscent Anti-Bacterial Triclosan SOAP TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333E New World Imports TRICLOSAN .003 g/g 51824-032_1b906299-b58a-4258-adbb-993bc0e9bcb6 51824-032 HUMAN OTC DRUG CAREALL Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20130404 OTC MONOGRAPH NOT FINAL part348 New World Imports Inc ZINC OXIDE .2 g/g 51824-033_dd488908-d864-4b6e-b542-d943b10bc815 51824-033 HUMAN OTC DRUG CAREALL Vitamin A and D Lanolin and Petrolatum OINTMENT TOPICAL 20120501 OTC MONOGRAPH FINAL part347 New World Imports, Inc LANOLIN; PETROLATUM .01; .97 g/g; g/g 51824-034_8d2c9955-02ca-4945-ad47-4e659d1f1b60 51824-034 HUMAN OTC DRUG Freshmint Premium Anticavity Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130404 OTC MONOGRAPH FINAL part355 New World Imports, Inc SODIUM FLUORIDE 2.43 mg/g 51824-035_c2838eef-b2c4-4e94-a03d-b99a815781a6 51824-035 HUMAN OTC DRUG Freshscent Sport Antibacterial Triclocarban SOAP TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part333E New World Imports, Inc TRICLOCARBAN 6 mg/g 51824-036_bebb265b-f207-4b1e-a37d-47d9a622e014 51824-036 HUMAN OTC DRUG Freshscent Antibacterial Deodorant Triclocarban SOAP TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part333E New World Imports, Inc TRICLOCARBAN 6 mg/g 51824-037_8ef5387b-daad-4ff9-a89e-6a09d040c69f 51824-037 HUMAN OTC DRUG Senna Laxative SENNOSIDES TABLET ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 New World Imports SENNOSIDES 8.6 mg/1 51824-038_1e426289-a4a0-485d-9862-81d502501970 51824-038 HUMAN OTC DRUG CAREALL Artifical Tears Glycerin, Hypromellose, Polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20140101 OTC MONOGRAPH FINAL part349 New World Imports, Inc GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2; 2; 10 mg/mL; mg/mL; mg/mL 51824-039_591c5967-1d8c-45ce-a46e-f33e6a286936 51824-039 HUMAN OTC DRUG CAREALL Eyedrops Original Tetrahydrozoline HCI SOLUTION/ DROPS OPHTHALMIC 20140601 OTC MONOGRAPH FINAL part349 New World Imports, Inc TETRAHYDROZOLINE HYDROCHLORIDE .05 mg/mL 51824-040_b5b59951-49af-4eb6-852d-ecdae6894672 51824-040 HUMAN OTC DRUG CAREALL Lubricating Eye Drops Dextran, Hydroxypropyl Methylcellulose SOLUTION/ DROPS OPHTHALMIC 20140601 OTC MONOGRAPH FINAL part349 New World Imports, Inc DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S) .1; .3 mg/mL; mg/mL 51824-041_77c6e115-6bba-45fd-8d49-f5d47a6c6e59 51824-041 HUMAN OTC DRUG CAREALL Petroleum PETROLATUM JELLY TOPICAL 20140601 OTC MONOGRAPH FINAL part347 New World Imports, Inc PETROLATUM 1 g/g 51824-042_c9c705a6-9027-4089-8e79-7e276e0fd239 51824-042 HUMAN OTC DRUG CareAll Medicated Chest Rub Camphor, Menthol, Eucalyptus OINTMENT TOPICAL 20140701 OTC MONOGRAPH FINAL part341 New World Imports, Inc CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL .048; .012; .026 g/g; g/g; g/g 51824-043_ec36c568-8435-4a80-8b9d-91a7a338635f 51824-043 HUMAN OTC DRUG Freshscent Antibacterial Deodorant Triclocarban SOAP TOPICAL 20140513 OTC MONOGRAPH NOT FINAL part333E New World Imports, Inc TRICLOCARBAN 6 mg/g 51824-044_f0100c4c-7762-420c-ae13-642029277abe 51824-044 HUMAN OTC DRUG Freshscent Sport Antibacterial Triclocarban SOAP TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part333E New World Imports, Inc TRICLOCARBAN 6 mg/g 51824-045_08a6234a-aacf-4a12-b76d-cbc8ac408b3a 51824-045 HUMAN OTC DRUG CareAll Medicated Chest Rub Camphor, Menthol, Eucalyptus OINTMENT TOPICAL 20140709 OTC MONOGRAPH FINAL part341 New World Imports, Inc CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL .048; .012; .026 g/g; g/g; g/g 51824-048_0310775e-cdf0-45a9-a454-a87036eaf77a 51824-048 HUMAN OTC DRUG Diphenhydramine Diphenhydramine Hydrochloride TABLET, COATED ORAL 20100909 OTC MONOGRAPH FINAL part341 New World Imports, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 51824-164_085a852f-2c1a-4c15-b106-9eae643fde5a 51824-164 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 20110831 OTC MONOGRAPH FINAL part343 New World Imports, Inc ASPIRIN 81 mg/1 51824-198_6a617c11-4c53-459f-ad31-bad2c73c1828 51824-198 HUMAN OTC DRUG Senna Sennosides TABLET ORAL 20101111 20150428 OTC MONOGRAPH NOT FINAL part334 New World Imports SENNOSIDES A AND B 8.6 mg/1 51824-217_9a8b3c44-430d-4954-b2f5-993787e54983 51824-217 HUMAN OTC DRUG Sennosides Sennosides TABLET ORAL 20100910 OTC MONOGRAPH NOT FINAL part334 New World Imports, Inc SENNOSIDES A AND B 8.6 mg/1 51824-245_78067bb0-33c2-4fa8-8bd3-3d664ee15670 51824-245 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20100910 OTC MONOGRAPH NOT FINAL part343 New World Imports IBUPROFEN 200 mg/1 51824-267_0db18565-6603-4662-a685-56fdf59c081a 51824-267 HUMAN OTC DRUG Non-Aspirin PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20120901 OTC MONOGRAPH NOT FINAL part343 New World Imports, Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 51824-422_fff908e9-2b8c-4b5a-9ed7-38011e9ba2ad 51824-422 HUMAN OTC DRUG NWI Artificial Tears Eye Glycerin SOLUTION/ DROPS OPHTHALMIC 20130912 OTC MONOGRAPH FINAL part349 New World Imports GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 .02; .02; .1 mg/10mg; mg/10mg; mg/10mg 51824-423_6fb133d2-ce91-4ca5-af5a-99d6e8bd6c20 51824-423 HUMAN OTC DRUG Artifical Tears Glycerin, Hypromellose, Polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20111101 OTC MONOGRAPH FINAL part349 New World Imports, Inc GLYCERIN; HYPROMELLOSE 2910 (15 MPA.S); POLYETHYLENE GLYCOL 400 2; 2; 10 mg/mL; mg/mL; mg/mL 51824-472_b8d15410-23eb-42a5-a39c-c8fbef1edb32 51824-472 HUMAN OTC DRUG Freshmist Sensitive Toothpaste Potassium Nitrate and Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100916 OTC MONOGRAPH FINAL part355 New World Imports, Inc POTASSIUM NITRATE; SODIUM FLUORIDE 2.4; 50 mg/g; mg/g 51824-473_6066a1c4-9443-4334-947f-8e9355bbe986 51824-473 HUMAN OTC DRUG Freshmint Anticavity Flouride Toothpaste Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20100916 OTC MONOGRAPH FINAL part355 New World Imports, Inc SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 51824-474_340a2e45-378e-44df-8cb4-e91e4b56dc56 51824-474 HUMAN OTC DRUG Freshmint Anticavity Fluoride Toothpaste Sodium Fluoride GEL, DENTIFRICE DENTAL 20100917 OTC MONOGRAPH FINAL part355 New World Imports, Inc SODIUM FLUORIDE 2.2 mg/g 51824-534_1c246307-70d4-4c62-9e5e-339dc6866b23 51824-534 HUMAN OTC DRUG Vitamin A and D Lanolin and Petrolatum OINTMENT TOPICAL 20110119 OTC MONOGRAPH FINAL part347 New World Imports, Inc LANOLIN; PETROLATUM .01; .76 g/g; g/g 51824-547_0adc956a-3198-46cf-b56d-0e4eef59d21b 51824-547 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20110125 OTC MONOGRAPH FINAL part343 New World Imports, Inc ASPIRIN 81 mg/1 51824-561_6a6f768f-5fa1-4cd0-96ae-a48bd82dffc8 51824-561 HUMAN OTC DRUG Senna-S Laxative DOCUSATE SODIUM, SENNOSIDES TABLET, COATED ORAL 20120430 OTC MONOGRAPH NOT FINAL part334 New World Imports DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 51824-600_89048a07-17c5-4359-9058-b07a756a86d2 51824-600 HUMAN OTC DRUG freshscent Anti-Bacterial TRICLOSAN SOAP TOPICAL 20130102 OTC MONOGRAPH FINAL part333E New World Imports TRICLOSAN .3 g/100g 51830-019_944084b6-7eb0-42fd-8f40-5b22812e1001 51830-019 HUMAN OTC DRUG Lightening Day Cream DICAPRYLYL CARBONATE CREAM TOPICAL 20120718 UNAPPROVED DRUG OTHER LANGE SAS POLYETHYLENE GLYCOL 400 2.5 mg/50mg 51830-020_618e21fc-0327-4292-a3a5-4ecfa0e31369 51830-020 HUMAN OTC DRUG Lightening Night Cream Ethyl Macadamiate CREAM TOPICAL 20120718 UNAPPROVED DRUG OTHER LANGE SAS ETHYL MACADAMIATE 1 mg/50mg 51830-022_d2f49e5c-313e-4646-b0ea-3bdd2c396f49 51830-022 HUMAN OTC DRUG Lightening Serum Dicaprylyl Ether CREAM TOPICAL 20120718 UNAPPROVED DRUG OTHER Lange SAS CYCLOMETHICONE 5 .35 mg/20mg 51830-023_c3da5b4a-4ab9-42ac-844f-9f1fbc0ba607 51830-023 HUMAN OTC DRUG Dark Spot Corrector POLYETHYLENE GLYCOL 400 CREAM TOPICAL 20120917 UNAPPROVED DRUG OTHER LANGE SAS POLYETHYLENE GLYCOL 400 .3 mg/15mg 51830-030_c63a8bd4-f5e9-4e6b-8e1c-f8a951b64bd8 51830-030 HUMAN OTC DRUG Lift-me day cream with Anti-Ageing and Regenerative Silicium - UV Filters Octinoxate, Avobenzone, Oxybenzone CREAM TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 LANGE SAS AVOBENZONE; OCTINOXATE; OXYBENZONE 1.5; 3.25; 1.25 mL/50mL; mL/50mL; mL/50mL 51830-052_ab4c5085-ea1a-446b-8c44-81d3599f84a7 51830-052 HUMAN OTC DRUG Perfect Me Serum Salicylic Acid CREAM TOPICAL 20120718 UNAPPROVED DRUG OTHER Lange SAS SALICYLIC ACID 1 mg/20mg 51830-053_0867bfc3-a975-46d2-bd24-6fd33536b9fe 51830-053 HUMAN OTC DRUG Cleansing Foaming Gel Acne Pro Skin ZINC PIDOLATE GEL TOPICAL 20120718 OTC MONOGRAPH NOT FINAL part333D LANGE SAS IRIS GERMANICA VAR. FLORENTINA ROOT; SALICYLIC ACID; ZINC PIDOLATE 1.8; 12; .072 mg/120mg; mg/120mg; mg/120mg 51830-054_23c8b813-23a3-4a5b-bad3-e3a7d8d19896 51830-054 HUMAN OTC DRUG Preparing Tonic Salicylic Acid LOTION TOPICAL 20120718 OTC MONOGRAPH NOT FINAL part333D Lange SAS SALICYLIC ACID 1.8 mg/180mg 51849-1250_53fc5bec-808b-470d-ae08-14e1f3356581 51849-1250 HUMAN OTC DRUG JIDESHENG HEMORRHOID WITCH HAZEL, CARTHAMUS TINCTORIS FLOWER BED, CORYDALIS AMBIGUA TUBER, LONGICERA CAPRIFOLIUM CAPRIFOLIUM FLOWER OINTMENT RECTAL 20100515 OTC MONOGRAPH FINAL part346 NANTONG JIDESHENG BIOLOGY HEALTH CARE PRODUCTS CO LTD CARTHAMUS TINCTORIUS FLOWER BUD; CORYDALIS AMBIGUA TUBER; LONICERA CAPRIFOLIUM FLOWER; WITCH HAZEL 12.5; 12.5; 5; 12.5 mg/1000mg; mg/1000mg; mg/1000mg; mg/1000mg 51849-3574_b75c2d62-eb35-42f3-ab6d-23051bc9fe77 51849-3574 HUMAN OTC DRUG JiDeSheng Clotrimazole GEL TOPICAL 20101023 OTC MONOGRAPH FINAL part333C Nantong Jidesheng Biology Health Care Products Co., Ltd. CLOTRIMAZOLE 1 g/100g 51850-001_44818bac-16bf-458c-bb93-fece3b92346b 51850-001 HUMAN OTC DRUG LivRelief Ruta Graveolens CREAM TOPICAL 20100901 UNAPPROVED HOMEOPATHIC LivDerma Inc. RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]/50g 51850-002_93faf383-9a3a-410c-9aca-5960e990543e 51850-002 HUMAN OTC DRUG LivTac Ruta Graveolens SALVE TOPICAL 20100901 UNAPPROVED HOMEOPATHIC LivDerma Inc. RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]/50g 51852-100_cf361d71-0209-4d1d-af56-c29648c5d3fd 51852-100 HUMAN OTC DRUG First Aid Triple Antibiotic and Pain Relief Maximum Strength Bacitracin Zinc, Neomycin, Polymyxin B Sulfate, Pramoxine Hydrocloride OINTMENT TOPICAL 20101101 OTC MONOGRAPH FINAL part333B LIFElabs, a Division of Atico International USA, INC. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 51852-101_551c24bc-8859-4a83-b32b-1237329a7ffb 51852-101 HUMAN OTC DRUG Oral Analgesic Maximum Strength Benzocaine GEL TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part356 LIFElabs, a Division of Atico International USA, INC. BENZOCAINE 200 mg/g 51852-102_e199cc9f-e38c-43e9-a515-f868abcf931b 51852-102 HUMAN OTC DRUG Tolnaftate Tolnaftate CREAM TOPICAL 20101101 OTC MONOGRAPH FINAL part333C LIFElabs, a Division of Atico International, USA, INC. TOLNAFTATE 10 mg/g 51852-103_a523aa80-9557-40c6-b522-00471cdf364c 51852-103 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20101101 OTC MONOGRAPH FINAL part333C LIFElabs, a Division of Atico International USA, INC. CLOTRIMAZOLE 10 mg/g 51852-104_3dcac1b9-0103-4c58-b3d0-df808a739262 51852-104 HUMAN OTC DRUG Muscle and Joint Vanishing Scent Fast Penetrating Menthol GEL TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part348 LIFElabs, a Division of Atico International USA, INC. MENTHOL 25 mg/g 51852-105_f8376280-0476-4dfd-8be8-64312266def0 51852-105 HUMAN OTC DRUG Muscle Rub Maximum Strength Methyl Salicylate, Menthol, Camphor CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part348 LIFElabs, a Division of Atico International USA, INC. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g 51861-010_b49861d3-b5b4-45d4-be01-4f7293d9b90f 51861-010 HUMAN OTC DRUG SENSE Daytime Protective Broad Spectrum SPF 15 OCTINOXATE, OXYBENZONE, AVOBENZONE EMULSION TOPICAL 20120328 OTC MONOGRAPH FINAL part352 USANA Health Sciences, Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE 2; 7.5; 3 mL/100mL; mL/100mL; mL/100mL 51861-020_e94a1f99-007e-4c66-88b7-315fb1d5f03b 51861-020 HUMAN OTC DRUG Usana Active Calcium CALCIUM CARBONATE, MAGNESIUM OXIDE, CHOLECALCIFEROL, CALCIUM CITRATE, and MAGNESIUM CITRATE TABLET, CHEWABLE ORAL 20120328 OTC MONOGRAPH FINAL part331 Usana Health Sciences, Inc. CALCIUM CARBONATE; CALCIUM CITRATE; CHOLECALCIFEROL; MAGNESIUM CITRATE; MAGNESIUM OXIDE 356; 77.9; 200; 44.4; 158 mg/1; mg/1; [iU]/1; mg/1; mg/1 51861-102_c867b7b6-7ef9-4d05-8927-1bdebe31229c 51861-102 HUMAN OTC DRUG PRENATAL CHELATED MINERAL CALCIUM CITRATE, CALCIUM CARBONATE, POTASSIUM IODIDE, MAGNESIUM CITRATE, ZINC CITRATE, COPPER GLUCONATE, and FERROUS FUMARATE TABLET ORAL 20120411 UNAPPROVED DRUG OTHER USANA Health Sciences, Inc. CALCIUM CARBONATE; CALCIUM CITRATE; COPPER GLUCONATE; FERROUS FUMARATE; MAGNESIUM CITRATE; POTASSIUM IODIDE; ZINC CITRATE 30; 32.5; .5; 7; 75; 75; 5 mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1 51861-103_68124116-64a2-4192-a705-8e728855e94b 51861-103 HUMAN OTC DRUG Prenatal Mega Antioxidant VITAMIN A, ASCORBIC ACID, VITAMIN D, .ALPHA.-TOCOPHEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, FOLIC ACID, BIOTIN, and CALCIUM PANTOTHENATE TABLET ORAL 20120411 UNAPPROVED DRUG OTHER USANA Health Services, Inc. .ALPHA.-TOCOPHEROL; ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN D 100; 325; 75; 22.5; 50; 250; 10; 8; 6.75; 6.75; 3750; 450 [iU]/1; mg/1; ug/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 51862-131_e9637f3a-4de7-4b8d-8a67-fa6f00cbe296 51862-131 HUMAN PRESCRIPTION DRUG Theophylline Theophylline SOLUTION ORAL 20130503 ANDA ANDA091586 Liberta Pharma Inc THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 51862-140_55824b7f-4b55-4e07-b75e-68e9c9c623a5 51862-140 HUMAN PRESCRIPTION DRUG SALSALATE SALSALATE TABLET ORAL 20110522 UNAPPROVED DRUG OTHER Libertas Pharma, Inc. SALSALATE 500 mg/1 51862-142_55824b7f-4b55-4e07-b75e-68e9c9c623a5 51862-142 HUMAN PRESCRIPTION DRUG SALSALATE SALSALATE TABLET ORAL 20110522 UNAPPROVED DRUG OTHER Libertas Pharma, Inc. SALSALATE 750 mg/1 51862-146_ea090c94-1e09-4771-98d7-4f3444650a7d 51862-146 HUMAN PRESCRIPTION DRUG Selegiline Hydrochloride Selegiline Hydrochloride TABLET ORAL 20140524 ANDA ANDA074912 Libertas Pharma, Inc. SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] 51862-151_84943ab1-98d7-49a0-933e-6d36f0db9831 51862-151 HUMAN PRESCRIPTION DRUG Multi-Vitamin With Fluoride Multi-Vitamin With Fluoride TABLET, CHEWABLE ORAL 20110521 UNAPPROVED DRUG OTHER Libertas Pharma, Inc. ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A ACETATE 15; 60; 400; 4.5; .3; 13.5; 1.05; 1.2; .25; 1.05; 2500 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 51862-152_8a61e46d-d4fa-46be-8935-da6af40559d1 51862-152 HUMAN PRESCRIPTION DRUG Multi-Vitamin With Fluoride Multi-Vitamin With Fluoride TABLET, CHEWABLE ORAL 20110521 UNAPPROVED DRUG OTHER Libertas Pharma, Inc. ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A ACETATE 15; 60; 400; 4.5; .3; 13.5; 1.05; 1.2; .5; 1.05; 2500 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 51862-153_a4326e4b-62ae-4be3-8fd0-9bc4c456b8ab 51862-153 HUMAN PRESCRIPTION DRUG Multi-Vitamin With Fluoride Multi-Vitamin With Fluoride TABLET, CHEWABLE ORAL 20110521 UNAPPROVED DRUG OTHER Libertas Pharma, Inc. ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A ACETATE 15; 60; 400; 4.5; .3; 13.5; 1.05; 1.2; 1; 1.05; 2500 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 51862-155_65b3171f-5ee6-4d3d-8258-700cb565cdaa 51862-155 HUMAN PRESCRIPTION DRUG Amiodarone HCl Amiodarone Hydrochloride TABLET ORAL 20130101 ANDA ANDA077069 Libertas Pharma, Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 51862-156_65b3171f-5ee6-4d3d-8258-700cb565cdaa 51862-156 HUMAN PRESCRIPTION DRUG Amiodarone HCl Amiodarone Hydrochloride TABLET ORAL 20130101 ANDA ANDA077069 Libertas Pharma, Inc. AMIODARONE HYDROCHLORIDE 400 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 51862-161_33fd4fe4-24f6-4a55-a4d7-fe414465eeb2 51862-161 HUMAN PRESCRIPTION DRUG Multi Vitamin and Fluoride Multi Vitamin and Fluoride SOLUTION/ DROPS ORAL 20110521 UNAPPROVED DRUG OTHER Libertas Pharma, Inc. ALPHA-TOCOPHEROL; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE 5; 35; 400; 2; 8; .4; .6; .25; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 51862-162_95f7711e-bc43-4f14-aadf-6c401740416a 51862-162 HUMAN PRESCRIPTION DRUG Multi Vitamin and Fluoride Multivitamin and Fluoride SOLUTION/ DROPS ORAL 20110521 UNAPPROVED DRUG OTHER Libertas Pharma, Inc. ALPHA-TOCOPHEROL; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE 5; 35; 400; 2; 8; .4; .6; .5; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 51862-163_cdeca352-ca84-4876-b218-e5b71851566d 51862-163 HUMAN PRESCRIPTION DRUG Multi Vitamin, Iron and Fluoride Multi Vitamin, Iron and Fluoride SOLUTION/ DROPS ORAL 20110521 UNAPPROVED DRUG OTHER Libertas Pharma, Inc. ALPHA-TOCOPHEROL; ASCORBIC ACID; CHOLECALCIFEROL; IRON; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE 5; 35; 400; 10; 8; .4; .6; .25; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 51862-164_7ad45bff-373a-4936-b71c-dc21a898d8c2 51862-164 HUMAN PRESCRIPTION DRUG VITAMINS A, C, D and FLUORIDE VITAMINS A, C, D and FLUORIDE SOLUTION/ DROPS ORAL 20110521 UNAPPROVED DRUG OTHER Libertas Pharma, Inc. ASCORBIC ACID; CHOLECALCIFEROL; SODIUM FLUORIDE; VITAMIN A PALMITATE 35; 400; .25; 1500 mg/mL; [iU]/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC] 51862-165_523ade1d-0bd9-42ba-94e8-647e665aa3e9 51862-165 HUMAN PRESCRIPTION DRUG Sodium Fluoride Sodium Fluoride SOLUTION/ DROPS ORAL 20110521 UNAPPROVED DRUG OTHER Libertas Pharma, Inc. SODIUM FLUORIDE .5 mg/mL 51862-171_79416bf8-bc96-4c9c-8be8-65c0357252bd 51862-171 HUMAN PRESCRIPTION DRUG Fluoride Fluoride TABLET, CHEWABLE ORAL 20110521 UNAPPROVED DRUG OTHER Libertas Pharma, Inc. SODIUM FLUORIDE .5 mg/1 51862-172_00e1f644-1538-4054-b112-227e7254317e 51862-172 HUMAN PRESCRIPTION DRUG Fluoride Fluoride TABLET, CHEWABLE ORAL 20110521 UNAPPROVED DRUG OTHER Libertas Pharma, Inc. SODIUM FLUORIDE 1 mg/1 51862-175_0a950732-ef8c-4c6b-b3d2-395c45a32ae2 51862-175 HUMAN PRESCRIPTION DRUG UR N-C Urinary Antiseptic Hyoscyamine Sulfate, Methenamine, Phenyl Salicylate, Sodium Phosphate Monobasic, Methylene Blue TABLET ORAL 20110521 UNAPPROVED DRUG OTHER Libertas Pharma, Inc. HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .12; 81.6; 10.8; 36.2; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1 51862-179_66d55380-528a-4ae0-9c72-dc99fdf131d7 51862-179 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine CAPSULE ORAL 20120416 ANDA ANDA089007 Libertas Pharma, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 51862-180_54a5e0e3-a400-4cc8-87eb-bcab8309786d 51862-180 HUMAN OTC DRUG Pramoxine hydrochloride Pramoxine hydrochloride AEROSOL, FOAM TOPICAL 20111031 OTC MONOGRAPH FINAL part346 Libertas Pharma, Inc. PRAMOXINE HYDROCHLORIDE 10 mg/g 51862-181_5ad3c07b-fee0-44e8-810e-dbfc6abac9ee 51862-181 HUMAN PRESCRIPTION DRUG Urea Urea GEL TOPICAL 20111028 UNAPPROVED DRUG OTHER Libertas Pharma, Inc. UREA 450 mg/g 51862-182_0e5d02d2-fa60-46e9-b45c-9fd5ee51a637 51862-182 HUMAN PRESCRIPTION DRUG UREA UREA CREAM TOPICAL 20111007 UNAPPROVED DRUG OTHER Libertas Pharma, Inc. UREA 450 mg/g 51862-210_01b5ea4d-0f75-476d-a53c-c469107a6a3b 51862-210 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20110727 ANDA ANDA090912 Libertas Pharma, Inc. ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 51862-211_01b5ea4d-0f75-476d-a53c-c469107a6a3b 51862-211 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20110727 ANDA ANDA090912 Libertas Pharma, Inc. ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 51862-212_01b5ea4d-0f75-476d-a53c-c469107a6a3b 51862-212 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20110727 ANDA ANDA090912 Libertas Pharma, Inc. ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 51862-215_bb6d6a9e-46af-4800-aad4-2425299a5be2 51862-215 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 ANDA ANDA090118 Libertas Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 51862-216_bb6d6a9e-46af-4800-aad4-2425299a5be2 51862-216 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 ANDA ANDA090118 Libertas Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 51862-217_bb6d6a9e-46af-4800-aad4-2425299a5be2 51862-217 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 ANDA ANDA090118 Libertas Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 51862-227_64fc77b7-7822-4a90-84e6-f84f7d011854 51862-227 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 ANDA ANDA090118 Libertas Pharma Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 51862-228_64fc77b7-7822-4a90-84e6-f84f7d011854 51862-228 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 ANDA ANDA090118 Libertas Pharma Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 51862-229_64fc77b7-7822-4a90-84e6-f84f7d011854 51862-229 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 ANDA ANDA090118 Libertas Pharma Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 51870-000_cec4f1b8-576e-4a58-befe-a0c1c1313443 51870-000 HUMAN OTC DRUG NEXT 1 Anti-bacterial TRICLOCARBAN SOAP TOPICAL 20131031 OTC MONOGRAPH NOT FINAL part333E Keefe Group TRICLOCARBAN 1.5 g/100g 51870-001_e37376d2-96a6-4041-bbc3-8575950a3da1 51870-001 HUMAN OTC DRUG Roll On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20120626 OTC MONOGRAPH FINAL part350 Keefe Group ALUMINUM CHLOROHYDRATE 14 mg/100mL 51879-110_08c86fc6-478a-288b-e054-00144ff88e88 51879-110 HUMAN OTC DRUG Tecnu Corticool Hydrocortisone GEL TOPICAL 19990623 OTC MONOGRAPH NOT FINAL part348 Tec Laboratories, Inc. HYDROCORTISONE 10 mg/g 51879-161_3e563e26-65d4-4f4d-ae25-5a29ba37e433 51879-161 HUMAN OTC DRUG Tecnu Rash Relief grindelia robusta, calendula officinalis SPRAY TOPICAL 20110114 UNAPPROVED HOMEOPATHIC Tec Laboratories, Inc. CALENDULA OFFICINALIS FLOWER; GRINDELIA HIRSUTULA FLOWERING TOP; PLANTAGO MAJOR 3; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 51879-180_08c9d3dd-7178-0148-e054-00144ff8d46c 51879-180 HUMAN OTC DRUG Licefreee Head Lice Treatment SPRAY TOPICAL 20090501 UNAPPROVED HOMEOPATHIC Tec Laboratories, Inc. SODIUM CHLORIDE 2 [hp_X]/mL 51879-190_ab276d77-793d-47c9-ae17-16ad06c8103e 51879-190 HUMAN OTC DRUG Licefreee Everyday natrum muriaticum SHAMPOO TOPICAL 20110105 UNAPPROVED HOMEOPATHIC Tec Laboratories, Inc. SODIUM CHLORIDE 1 [hp_X]/g 51879-210_44878ea4-d0e9-4509-8210-1a64f2cdb4d0 51879-210 HUMAN OTC DRUG Tecnu First Aid benzethonium chloride, lidocaine hydrochloride GEL TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part348 Tec Laboratories, Inc. BENZETHONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 2; 25 mg/g; mg/g 51885-3100_53119310-7895-4a9f-a73e-964dea5f5ec5 51885-3100 HUMAN OTC DRUG Luffeel GALPHIMIA GLAUCA FLOWERING TOP and HISTAMINE DIHYDROCHLORIDE and LUFFA OPERCULATA FRUIT and SULFUR SPRAY NASAL 20110705 UNAPPROVED HOMEOPATHIC Biologische Heilmittel Heel GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; SULFUR 4; 12; 4; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL 51885-3150_b8dd861c-013d-45bc-8db1-f10305a7acb5 51885-3150 HUMAN OTC DRUG Sinusin PULSATILLA VULGARIS and EUPHORBIA RESINIFERA RESIN and LUFFA OPSILVER NITRATEERCULATA FRUIT and MERCURIC IODIDE and SUS SCROFA NASAL MUCOSA and SILVER NITRATE and CALCIUM SULFIDE and SINUSITISINUM SOLUTION ORAL 20110101 UNAPPROVED HOMEOPATHIC Biologische Heilmittel Heel CALCIUM SULFIDE; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; PULSATILLA VULGARIS; SILVER NITRATE; SINUSITISINUM; SUS SCROFA NASAL MUCOSA 10; 4; 6; 8; 2; 10; 13; 8 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL 51885-3260_fabef9d6-503c-4215-b313-31c58b39855f 51885-3260 HUMAN OTC DRUG Sinusin SILVER NITRATE, EUPHORBIA RESINIFERA RESIN, CALCIUM SULFIDE, LUFFA OPERCULATA FRUIT, MERCURIC IODIDE, SUS SCROFA NASAL MUCOSA, PULSATILLA VULGARIS and SINUSITISINUM SPRAY NASAL 20120203 UNAPPROVED HOMEOPATHIC Biologische Heilmittel Heel CALCIUM SULFIDE; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; PULSATILLA VULGARIS; SILVER NITRATE; SINUSITISINUM; SUS SCROFA NASAL MUCOSA 10; 4; 2; 8; 2; 10; 13; 8 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL 51885-3302_93fdee06-d799-4e40-97c0-8b46af0687c5 51885-3302 HUMAN OTC DRUG Traumeel CALENDULA OFFICINALIS FLOWERING TOP and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK and ARNICA MONTANA ROOT and ACONITUM NAPELLUS and ATROPA BELLADONNA and BELLIS PERENNIS and MATRICARIA RECUTITA and ECHINACEA, UNSPECIFIED and ECHINACEA PURPUREA and ACHILLEA MILLEFOLIUM and CALCIUM SULFIDE and MERCURIUS SOLUBILIS and COMFREY ROOT and HYPERICUM PERFORATUM and OINTMENT TOPICAL 19861031 UNAPPROVED HOMEOPATHIC Biologische Heilmittel Heel ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS 1; 3; 3; 3; 1; 8; 1; 4; 1; 1; 1; 6; 1; 8 [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g 51885-3310_3d512200-21e6-4fb0-8c82-b85728de4a1e 51885-3310 HUMAN OTC DRUG Traumeel CALENDULA OFFICINALIS FLOWERING TOP and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK and ARNICA MONTANA ROOT and ACONITUM NAPELLUS and ATROPA BELLADONNA and BELLIS PERENNIS and MATRICARIA RECUTITA and ECHINACEA, UNSPECIFIED and ECHINACEA PURPUREA and ACHILLEA MILLEFOLIUM and CALCIUM SULFIDE and MERCURIUS SOLUBILIS and COMFREY ROOT and HYPERICUM PERFORATUM and GEL TOPICAL 19991031 UNAPPROVED HOMEOPATHIC Biologische Heilmittel Heel ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS 1; 3; 3; 3; 1; 8; 1; 4; 1; 1; 1; 6; 1; 8 [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g 51885-3353_fe3f3fc6-bf04-416d-b1a9-f2a39935608a 51885-3353 HUMAN OTC DRUG Zeel SILICON DIOXIDE and COMFREY ROOT and ARNICA MONTANA ROOT and TOXICODENDRON PUBESCENS LEAF and SULFUR and SANGUINARIA CANADENSIS ROOT and SOLANUM DULCAMARA STEM and COENZYME A and NADIDE and SODIUM DIETHYL OXALACETATE and .ALPHA.-LIPOIC ACID and SUS SCROFA CARTILAGE and SUS SCROFA EMBRYO and SUS SCROFA UMBILICAL CORD and SUS SCROFA PLACENTA and OINTMENT TOPICAL 20111020 UNAPPROVED HOMEOPATHIC Biologische Heilmittel Heel .ALPHA.-LIPOIC ACID; ARNICA MONTANA ROOT; COENZYME A; COMFREY ROOT; NADIDE; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; SODIUM DIETHYL OXALACETATE; SOLANUM DULCAMARA STEM; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF 6; 2; 6; 8; 6; 2; 6; 6; 2; 6; 2; 2; 2; 2; 2 [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g 51885-4996_2ffb4012-e1ca-4392-be51-fb3273d2c574 51885-4996 HUMAN OTC DRUG Chelidonium Homaccord CHELIDONIUM MAJUS and ATROPA BELLADONNA SOLUTION ORAL 20110217 UNAPPROVED HOMEOPATHIC Biologische Heilmittel Heel ATROPA BELLADONNA; CHELIDONIUM MAJUS 10; 10 [hp_X]/1.1mL; [hp_X]/1.1mL 51885-7125_115a8772-4be5-46fd-ac5d-09ccb483889f 51885-7125 HUMAN OTC DRUG Traumeel X CALENDULA OFFICINALIS FLOWERING TOP and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK and ARNICA MONTANA ROOT and ACONITUM NAPELLUS and ATROPA BELLADONNA and BELLIS PERENNIS and MATRICARIA RECUTITA and ECHINACEA, UNSPECIFIED and ECHINACEA PURPUREA and ACHILLEA MILLEFOLIUM and CALCIUM SULFIDE and MERCURIUS SOLUBILIS and COMFREY ROOT and HYPERICUM PERFORATUM and OINTMENT TOPICAL 20120524 UNAPPROVED HOMEOPATHIC Biologische Heilmittel Heel ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS 1; 1; 3; 1; 1; 6; 1; 4; 1; 1; 1; 6; 1; 6 g/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; g/50g; [hp_X]/50g; g/50g; [hp_X]/50g; g/50g; g/50g; g/50g; [hp_X]/50g; g/50g; [hp_X]/50g 51885-7500_b14584f8-bef2-4063-94da-52f17c109220 51885-7500 HUMAN OTC DRUG Vinceel APIS MELLIFERA and CYNANCHUM VINCETOXICUM LEAF and ATROPA BELLADONNA and CALENDULA OFFICINALIS FLOWERING TOP and ECHINACEA PURPUREA and PHYTOLACCA AMERICANA ROOT and PLANTAGO MAJOR and SAGE SPRAY ORAL 20060831 UNAPPROVED HOMEOPATHIC Biologische Heilmittel Heel APIS MELLIFERA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; CYNANCHUM VINCETOXICUM LEAF; ECHINACEA PURPUREA; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; SAGE 7; 5; 3; 5; 5; 3; 3; 3 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL 51885-8130_d954ffc0-1c1d-4d8b-9ce3-e771c592439f 51885-8130 HUMAN OTC DRUG Traumeel X ACONITUM NAPELLUS and ARNICA MONTANA ROOT and ATROPA BELLADONNA and BELLIS PERENNIS and CALENDULA OFFICINALIS FLOWERING TOP and MATRICARIA RECUTITA and ECHINACEA, UNSPECIFIED and ECHINACEA PURPUREA and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK and CALCIUM SULFIDE and HYPERICUM PERFORATUM and MERCURIUS SOLUBILIS and ACHILLEA MILLEFOLIUM and COMFREY ROOT GEL TOPICAL 20130215 UNAPPROVED HOMEOPATHIC Biologische Heilmittel Heel ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS 1; 1; 3; 1; 1; 6; 1; 4; 1; 1; 1; 6; 1; 6 g/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; g/50g; [hp_X]/50g; g/50g; [hp_X]/50g; g/50g; g/50g; g/50g; [hp_X]/50g; g/50g; [hp_X]/50g 51887-001_2df64934-dac0-479d-80fb-ff5865f5ba42 51887-001 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Maine Oxy Acetylene Supply Co., Inc. NITROGEN 99 L/100L 51887-100_28a01dbb-a5c9-4d38-8346-0ce3d7374a82 51887-100 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Maine Oxy Acetylene Supply Co., Inc. NITROGEN 99 L/100L 51918-1001_44f13ab9-0616-41f9-bd19-d0f75e8d558c 51918-1001 HUMAN OTC DRUG Cheong-Kwan-Jang Korean HongSam ASIAN GINSENG CAPSULE ORAL 20101115 UNAPPROVED DRUG OTHER Korea Ginseng Corporation ASIAN GINSENG 500 mg/500mg 51918-1002_20c1042b-7a63-4ec5-8055-97c4a5723a4a 51918-1002 HUMAN OTC DRUG Cheong-Kwan-Jang Korean HongSam ASIAN GINSENG TABLET ORAL 20110224 UNAPPROVED DRUG OTHER Korea Ginseng Corporation ASIAN GINSENG 500 mg/90000mg 51918-1003_bf605d58-852f-45ec-81ac-aadd3db006ed 51918-1003 HUMAN OTC DRUG Cheong-Kwan-Jang Korean HongSam ASIAN GINSENG POWDER ORAL 20101008 UNAPPROVED DRUG OTHER Korea Ginseng Corporation ASIAN GINSENG 90 g/90g 51918-1005_01721e43-6c3e-455a-aeee-05d3e84183a5 51918-1005 HUMAN OTC DRUG Cheong-Kwan-Jang Sliced Korean HongSam ASIAN GINSENG BAR, CHEWABLE ORAL 20110531 UNAPPROVED DRUG OTHER Korea Ginseng Corporation ASIAN GINSENG 75 g/75g 51954-100_54a74815-e7da-4ae1-916e-e6039ea355eb 51954-100 HUMAN OTC DRUG DERMA ICE BURN RELIEF with Aloe Vera LIDOCAINE SOLUTION TOPICAL 20110120 OTC MONOGRAPH FINAL part348 Derma Ice LLC LIDOCAINE 10 mg/mL 51960-001_5460a4b7-0f40-4229-ac45-9a3363452997 51960-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19980101 UNAPPROVED MEDICAL GAS Kent Welding Supply OXYGEN 99 L/100L 51978-1001_7d5b3c37-847d-4db5-860c-180f6892ddee 51978-1001 HUMAN OTC DRUG Artemisia No Smoking WORMWOOD INHALANT ORAL 20140110 UNAPPROVED DRUG OTHER Donghwa Pharm Co., Ltd WORMWOOD 1 g/g 51979-001_8215c6ed-5704-44de-8c75-9077610021b3 51979-001 HUMAN OTC DRUG Ouch Aid Arnica Compress Arnica Montana TINCTURE TOPICAL 20100910 UNAPPROVED HOMEOPATHIC Dr. Hauschka SkinCare Inc. ARNICA MONTANA 4 g/1 51985-010_e300aeff-a738-4157-a286-82ed693b1e50 51985-010 HUMAN OTC DRUG IONTOPHORESIS ANTI AGING SOLUTION I ALLANTOIN LOTION CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 ROCKET ELECTRIC CO., LTD. ALLANTOIN .1 mL/20mL 51987-0002_5df8b718-71e1-4014-8641-98caf3346822 51987-0002 HUMAN OTC DRUG Hydrate II Coffea Tosta, Avena Sativa, Equisetum Hyemale, Hypericum Perforatum, Ginkgo Biloba, Germanium Sesquioxide, Silicea LIQUID ORAL 20130822 UNAPPROVED HOMEOPATHIC Maplewood Company AVENA SATIVA FLOWERING TOP; COFFEA ARABICA SEED, ROASTED; EQUISETUM HYEMALE; GERMANIUM SESQUIOXIDE; GINKGO; HYPERICUM PERFORATUM; SILICON DIOXIDE 3; 2; 3; 8; 6; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 51991-073_2d433ed3-4376-4849-8943-d832cfd73462 51991-073 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Butalbital, Acetaminophen, Caffeine and Codeine Phosphate CAPSULE ORAL 20040701 ANDA ANDA076560 Breckenridge Pharmaceutical, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 51991-074_3ab46727-2997-4e4e-8b0b-b69b00db9ca5 51991-074 HUMAN PRESCRIPTION DRUG Ascomp with Codeine Butalbital, Aspirin, Caffeine and Codeine Phosphate CAPSULE ORAL 20090501 ANDA ANDA075231 Breckenridge Pharmaceutical, Inc. ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 51991-167_31cb9a2c-8360-4ae4-ab04-cb25eea798d9 51991-167 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20090928 ANDA ANDA077708 Breckenridge Pharmaceutical, Inc. CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 51991-168_31cb9a2c-8360-4ae4-ab04-cb25eea798d9 51991-168 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20090928 ANDA ANDA077708 Breckenridge Pharmaceutical, Inc. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 51991-188_9500c454-89dc-4ea2-a396-8a023dc85580 51991-188 HUMAN PRESCRIPTION DRUG MethylpredniSOLONE METHYLPREDNISOLONE TABLET ORAL 20031107 ANDA ANDA040189 Breckenridge Pharmaceutical, Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51991-191_6d3fa9e9-eb31-40f8-b4fa-e1c7c3f89006 51991-191 HUMAN PRESCRIPTION DRUG Methscopolamine Bromide methscopolamine bromide TABLET ORAL 20120521 ANDA ANDA040642 Breckenridge Pharmaceutical, Inc. METHSCOPOLAMINE BROMIDE 2.5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 51991-192_6d3fa9e9-eb31-40f8-b4fa-e1c7c3f89006 51991-192 HUMAN PRESCRIPTION DRUG Methscopolamine Bromide methscopolamine bromide TABLET ORAL 20120521 ANDA ANDA040642 Breckenridge Pharmaceutical, Inc. METHSCOPOLAMINE BROMIDE 5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 51991-292_825668cd-1b5d-4968-90f1-424291363a79 51991-292 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20080111 ANDA ANDA078069 Breckenridge Pharmaceutical, Inc. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51991-293_825668cd-1b5d-4968-90f1-424291363a79 51991-293 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20080111 ANDA ANDA078069 Breckenridge Pharmaceutical, Inc. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51991-294_825668cd-1b5d-4968-90f1-424291363a79 51991-294 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20080111 ANDA ANDA078069 Breckenridge Pharmaceutical, Inc. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51991-316_384a5deb-28a0-43af-9939-9e7440309a29 51991-316 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20120425 ANDA ANDA201003 Breckenridge Pharmaceutical, Inc. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 51991-317_384a5deb-28a0-43af-9939-9e7440309a29 51991-317 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20120425 ANDA ANDA201003 Breckenridge Pharmaceutical, Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 51991-318_384a5deb-28a0-43af-9939-9e7440309a29 51991-318 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20120425 ANDA ANDA201003 Breckenridge Pharmaceutical, Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 51991-319_384a5deb-28a0-43af-9939-9e7440309a29 51991-319 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20120425 ANDA ANDA201003 Breckenridge Pharmaceutical, Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 51991-320_384a5deb-28a0-43af-9939-9e7440309a29 51991-320 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20120425 ANDA ANDA201003 Breckenridge Pharmaceutical, Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 51991-321_384a5deb-28a0-43af-9939-9e7440309a29 51991-321 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20120425 ANDA ANDA201003 Breckenridge Pharmaceutical, Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 51991-331_d2d59219-a4d1-4811-bf96-25019f96a97f 51991-331 HUMAN PRESCRIPTION DRUG Nevirapine NEVIRAPINE TABLET ORAL 20110411 ANDA ANDA078644 Breckenridge Pharmaceutical, Inc. NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 51991-333_1edca669-8879-408a-b09c-259e363dd95c 51991-333 HUMAN PRESCRIPTION DRUG Carbinoxamine Maleate carbinoxamine maleate TABLET ORAL 20121210 ANDA ANDA040442 Breckenridge Pharmaceutical, Inc. CARBINOXAMINE MALEATE 4 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 51991-334_1edca669-8879-408a-b09c-259e363dd95c 51991-334 HUMAN PRESCRIPTION DRUG Carbinoxamine Maleate carbinoxamine maleate SYRUP ORAL 20121210 ANDA ANDA040458 Breckenridge Pharmaceutical, Inc. CARBINOXAMINE MALEATE 4 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 51991-337_d180e88d-95b2-4caf-8183-27e70911e184 51991-337 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20121015 ANDA ANDA090007 Breckenridge Pharmaceutical, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51991-338_d180e88d-95b2-4caf-8183-27e70911e184 51991-338 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20121015 ANDA ANDA090007 Breckenridge Pharmaceutical, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51991-339_d180e88d-95b2-4caf-8183-27e70911e184 51991-339 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20121015 ANDA ANDA090007 Breckenridge Pharmaceutical, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51991-354_6412835d-cca0-452d-867a-f62b394c6873 51991-354 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20121231 ANDA ANDA200482 Breckenridge Pharmaceutical, Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 51991-355_6412835d-cca0-452d-867a-f62b394c6873 51991-355 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20121231 ANDA ANDA200482 Breckenridge Pharmaceutical, Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 51991-362_578999e6-0806-4e6b-972a-bf8d031c5fe3 51991-362 HUMAN PRESCRIPTION DRUG RIZATRIPTAN Benzoate RIZATRIPTAN Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA203478 Breckenridge Pharmaceutical, Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 51991-363_578999e6-0806-4e6b-972a-bf8d031c5fe3 51991-363 HUMAN PRESCRIPTION DRUG RIZATRIPTAN Benzoate RIZATRIPTAN Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA203478 Breckenridge Pharmaceutical, Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 51991-457_22194a8c-348c-4781-bb56-ff7aa1c6ea0e 51991-457 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20060906 ANDA ANDA077706 Breckenridge Pharmaceutical, Inc. POLYETHYLENE GLYCOL 3350 17 g/17g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 51991-467_384eddbb-9f1b-4d37-a6d9-ec87b2304555 51991-467 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20061206 ANDA ANDA077563 Breckenridge Pharmaceutical, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 51991-474_f03aebba-fc59-4417-bc51-79899c90c232 51991-474 HUMAN PRESCRIPTION DRUG Estradiol / Norethindrone Acetate Estradiol and Norethindrone Acetate TABLET, FILM COATED ORAL 20080417 ANDA ANDA078324 Breckenridge Pharmaceutical, Inc. ESTRADIOL; NORETHINDRONE ACETATE 1; .5 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 51991-526_63817e54-a55c-44a2-b226-65194640fe53 51991-526 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20101227 ANDA ANDA077714 Breckenridge Pharmaceutical, Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 51991-560_e8dbe065-c4ff-4feb-8d1c-9a5f757222bf 51991-560 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20101116 ANDA ANDA077973 Breckenridge Pharmaceutical, Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 51991-604_b192fda0-a689-408a-a667-b0fab4d5a5cd 51991-604 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20090817 ANDA ANDA040833 Breckenridge Pharmaceutical, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 51991-620_95eb0931-d177-40f6-9bf4-6ba20c9cbf43 51991-620 HUMAN PRESCRIPTION DRUG ANASTROZOLE ANASTROZOLE TABLET ORAL 20100628 ANDA ANDA079220 Breckenridge Pharmaceutical, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 51991-623_f03aebba-fc59-4417-bc51-79899c90c232 51991-623 HUMAN PRESCRIPTION DRUG Estradiol / Norethindrone Acetate Estradiol and Norethindrone Acetate TABLET, FILM COATED ORAL 20110609 ANDA ANDA078324 Breckenridge Pharmaceutical, Inc. ESTRADIOL; NORETHINDRONE ACETATE .5; .1 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 51991-628_e921c45f-c335-44e5-a3a7-d079035a04e4 51991-628 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101009 ANDA ANDA091450 Breckenridge Pharmaceutical, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 51991-629_e921c45f-c335-44e5-a3a7-d079035a04e4 51991-629 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101009 ANDA ANDA091450 Breckenridge Pharmaceutical, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 51991-630_e921c45f-c335-44e5-a3a7-d079035a04e4 51991-630 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101009 ANDA ANDA091450 Breckenridge Pharmaceutical, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 51991-631_e921c45f-c335-44e5-a3a7-d079035a04e4 51991-631 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101009 ANDA ANDA091450 Breckenridge Pharmaceutical, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 51991-632_e921c45f-c335-44e5-a3a7-d079035a04e4 51991-632 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101009 ANDA ANDA091450 Breckenridge Pharmaceutical, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 51991-647_8d436aca-22f2-40d2-a921-ba3afbf01893 51991-647 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20111101 ANDA ANDA090511 Breckenridge Pharmaceutical, Inc. LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51991-648_8d436aca-22f2-40d2-a921-ba3afbf01893 51991-648 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20111101 ANDA ANDA090511 Breckenridge Pharmaceutical, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51991-649_8d436aca-22f2-40d2-a921-ba3afbf01893 51991-649 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20111101 ANDA ANDA090511 Breckenridge Pharmaceutical, Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51991-650_8d436aca-22f2-40d2-a921-ba3afbf01893 51991-650 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20111101 ANDA ANDA090511 Breckenridge Pharmaceutical, Inc. LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51991-651_532492ea-c41a-49c3-8b7e-cf8b329a1fb4 51991-651 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20131119 ANDA ANDA079120 Breckenridge Pharmaceutical, Inc. LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 51991-708_55b4496a-7016-44a7-b32c-2b681463a1c2 51991-708 HUMAN PRESCRIPTION DRUG pioglitazone hydrochloride pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA078472 Breckenridge Pharmaceutical, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 51991-709_55b4496a-7016-44a7-b32c-2b681463a1c2 51991-709 HUMAN PRESCRIPTION DRUG pioglitazone hydrochloride pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA078472 Breckenridge Pharmaceutical, Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 51991-710_55b4496a-7016-44a7-b32c-2b681463a1c2 51991-710 HUMAN PRESCRIPTION DRUG pioglitazone hydrochloride pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA078472 Breckenridge Pharmaceutical, Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 51991-712_9175f211-fce1-4861-852a-1578dd3298b6 51991-712 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride SOLUTION ORAL 20100701 ANDA ANDA091601 Breckenridge Pharmaceutical, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 51991-713_9175f211-fce1-4861-852a-1578dd3298b6 51991-713 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride SOLUTION ORAL 20100701 ANDA ANDA091601 Breckenridge Pharmaceutical, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 51991-716_c78051e1-ffca-47eb-bdb6-eb81c717c893 51991-716 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20140129 ANDA ANDA079059 Breckenridge Pharmaceutical, Inc. RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] 51991-728_619c590f-30e1-499a-9428-80e2ccdcaa15 51991-728 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone SUSPENSION RECTAL 20101015 NDA NDA016199 Breckenridge Pharmaceutical, Inc. HYDROCORTISONE 100 mg/60mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 51991-735_04be396f-4491-4d60-8e24-5927087a5709 51991-735 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride TABLET ORAL 20090622 ANDA ANDA078969 Breckenridge Pharmaceutical, Inc. GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 51991-738_4066d1b3-2777-4107-8862-1b6f0d2d5e8e 51991-738 HUMAN PRESCRIPTION DRUG NEOMYCIN SULFATE NEOMYCIN SULFATE TABLET ORAL 20110103 ANDA ANDA065468 Breckenridge Pharmaceutical, Inc. NEOMYCIN SULFATE 500 mg/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 51991-746_cf81def0-1405-4305-bfdc-0673e95112bd 51991-746 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Breckenridge Pharmaceutical, Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51991-747_cf81def0-1405-4305-bfdc-0673e95112bd 51991-747 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Breckenridge Pharmaceutical, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51991-748_cf81def0-1405-4305-bfdc-0673e95112bd 51991-748 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Breckenridge Pharmaceutical, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 51991-759_053eb06e-d89a-4dcf-a86a-f9ad1077f52e 51991-759 HUMAN PRESCRIPTION DRUG LETROZOLE LETROZOLE TABLET ORAL 20110604 ANDA ANDA200161 Breckenridge Pharmaceutical, Inc. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 51991-771_0f3db4be-2eba-4308-bf95-8e6d8e735cf5 51991-771 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20121218 ANDA ANDA201921 Breckenridge Pharmaceutical, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 51991-772_0f3db4be-2eba-4308-bf95-8e6d8e735cf5 51991-772 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20121218 ANDA ANDA201921 Breckenridge Pharmaceutical, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 51991-781_e2aea230-11ea-48bd-8ad8-fb53cce42883 51991-781 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA203390 Breckenridge Pharmaceutical, Inc QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 51991-782_e2aea230-11ea-48bd-8ad8-fb53cce42883 51991-782 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA203390 Breckenridge Pharmaceutical, Inc QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 51991-783_e2aea230-11ea-48bd-8ad8-fb53cce42883 51991-783 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA203390 Breckenridge Pharmaceutical, Inc QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 51991-784_e2aea230-11ea-48bd-8ad8-fb53cce42883 51991-784 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA203390 Breckenridge Pharmaceutical, Inc QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 51991-785_e2aea230-11ea-48bd-8ad8-fb53cce42883 51991-785 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA203390 Breckenridge Pharmaceutical, Inc QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 51991-786_e2aea230-11ea-48bd-8ad8-fb53cce42883 51991-786 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA203390 Breckenridge Pharmaceutical, Inc QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 51991-793_a275c767-4ec9-41dd-af9c-d54a8a6b6020 51991-793 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20120613 ANDA ANDA091689 Breckenridge Pharmaceutical, Inc RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 51991-794_a275c767-4ec9-41dd-af9c-d54a8a6b6020 51991-794 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20120613 ANDA ANDA091689 Breckenridge Pharmaceutical, Inc RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 51991-795_a275c767-4ec9-41dd-af9c-d54a8a6b6020 51991-795 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20120613 ANDA ANDA091689 Breckenridge Pharmaceutical, Inc RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 51991-796_a275c767-4ec9-41dd-af9c-d54a8a6b6020 51991-796 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20120613 ANDA ANDA091689 Breckenridge Pharmaceutical, Inc RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 51991-817_e3eda8a2-8709-4883-a40e-18ca0f41728b 51991-817 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130311 ANDA ANDA078703 Breckenridge Pharmaceutical, Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51991-818_e3eda8a2-8709-4883-a40e-18ca0f41728b 51991-818 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130311 ANDA ANDA078703 Breckenridge Pharmaceutical, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51991-819_e3eda8a2-8709-4883-a40e-18ca0f41728b 51991-819 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130311 ANDA ANDA078703 Breckenridge Pharmaceutical, Inc. PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51991-820_e3eda8a2-8709-4883-a40e-18ca0f41728b 51991-820 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130311 ANDA ANDA078703 Breckenridge Pharmaceutical, Inc. PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 51991-836_f7e423fe-8514-48bc-a2bc-b76bd1c515c4 51991-836 HUMAN PRESCRIPTION DRUG Epinastine Hydrochloride Epinastine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20131105 ANDA ANDA090870 Breckenridge Pharmaceutical, Inc. EPINASTINE HYDROCHLORIDE .5 mg/mL Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 51991-837_ccf6faa6-4bed-4a74-a34a-927309dcb3b5 51991-837 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20131203 ANDA ANDA078488 Breckenridge Pharmaceutical, Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 51991-838_09ea763c-dc87-42ea-8a02-e488fc074d2a 51991-838 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20131021 ANDA ANDA040644 Breckenridge Pharmaceutical, Inc. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 51991-839_b1e5827a-02ee-4a88-b6ea-696842e3f012 51991-839 HUMAN PRESCRIPTION DRUG Mefenamic Acid Mefenamic Acid CAPSULE ORAL 20141013 ANDA ANDA090359 Breckenridge Pharmaceutical, Inc. MEFENAMIC ACID 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 51996-001_da07093a-c881-4fc0-9aaa-d62c3a012905 51996-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19760101 NDA NDA205840 Mississippi Welders Supply Company, Inc. OXYGEN 990 mL/L 51996-003_7b648384-dd90-4b2f-aed7-cf4426d90f15 51996-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20100301 NDA NDA205839 Mississippi Welders Supply Company, Inc. NITROGEN 990 mL/L 51997-035_4298c46d-2fc3-44f2-b096-fbce32d993fa 51997-035 HUMAN OTC DRUG Emergency Eye Wash, PW, Sterile Ster-Aide Water FOR SOLUTION OPHTHALMIC 20120910 OTC MONOGRAPH NOT FINAL part349 Asept Pak, Inc. WATER 14.85 mL/15mL 52000-000_dfb66c9b-7a5e-460d-9246-add7557a3f60 52000-000 HUMAN OTC DRUG Allure Creamy Petroleum PETROLATUM JELLY TOPICAL 20121219 OTC MONOGRAPH FINAL part347 Universal Distribution Center LLC PETROLATUM 30 g/100g 52000-001_d38ed427-5265-4081-9a9b-8c26ace4726b 52000-001 HUMAN OTC DRUG Allure Isopropyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120629 OTC MONOGRAPH FINAL part333A Universal Distribution Center LLC ISOPROPYL ALCOHOL 50 mL/100mL 52000-002_3ad3b5b6-0bb2-43fe-920f-eef7f6beeba9 52000-002 HUMAN OTC DRUG Allure Isopropyl Rubbing Alcohol With Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20120630 OTC MONOGRAPH FINAL part333A Universal Distribution Center LLC ISOPROPYL ALCOHOL 50 mL/100mL 52000-003_47d12679-b500-4813-b53d-c9d4e1d1bcde 52000-003 HUMAN OTC DRUG Allure Vaporizing Chest Rub Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20120630 OTC MONOGRAPH FINAL part341 Universal Distribution Center LLC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.7; 1; 1 g/100g; g/100g; g/100g 52000-004_da83c7c6-bf57-4c6e-bb44-d76c14c8cacc 52000-004 HUMAN OTC DRUG Allure Ice Cold Analgesic Menthol and Camphor GEL TOPICAL 20120630 OTC MONOGRAPH FINAL part341 Universal Distribution Center LLC CAMPHOR (SYNTHETIC); MENTHOL .5; 1 g/100g; g/100g 52000-005_5c0333ab-173d-465f-abf3-22f93cba6d32 52000-005 HUMAN OTC DRUG UNIVERSAL PURE PETROLEUM White Petroleum JELLY TOPICAL 20130206 OTC MONOGRAPH FINAL part347 Universal Distribution Center LLC PETROLATUM 1 g/g 52000-006_c3b383bd-a87f-48e2-b66a-33f37a741924 52000-006 HUMAN OTC DRUG UNIVERSAL BABY FRESH SCENT PETROLEUM White Petroleum JELLY TOPICAL 20130206 OTC MONOGRAPH FINAL part347 Universal Distribution Center LLC PETROLATUM .99 g/g 52000-007_489d6588-db36-4ad6-bb27-effe41162a89 52000-007 HUMAN OTC DRUG UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED White Petroleum JELLY TOPICAL 20130206 OTC MONOGRAPH FINAL part347 Universal Distribution Center LLC PETROLATUM 1 g/g 52000-008_92adc7a8-fb36-4bca-806d-c1bb753e359d 52000-008 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 50% Isopropyl Alcohol LIQUID TOPICAL 20120313 OTC MONOGRAPH NOT FINAL part333A Universal Distribution Center LLC ISOPROPYL ALCOHOL 50 mL/100mL 52000-009_4c4f771a-77e2-4024-bccc-1c79a90e5a6f 52000-009 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 50% With Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333A Universal Distribution Center LLC ISOPROPYL ALCOHOL 50 mL/100mL 52000-010_43ddb2eb-eba8-4838-b933-aa0ce14b2b16 52000-010 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70% Isopropyl Alcohol LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333A Universal Distribution Center LLC ISOPROPYL ALCOHOL 70 mL/100mL 52000-011_0913f786-de59-4d76-a36c-26de14a1de5c 52000-011 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70% With Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333A Universal Distribution Center LLC ISOPROPYL ALCOHOL 70 mL/100mL 52000-012_0b218f94-6be0-2ca5-e054-00144ff88e88 52000-012 HUMAN OTC DRUG Vaporizing Chest Rub Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20130315 OTC MONOGRAPH FINAL part341 Universal Distribution Center LLC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.7; 1; 1 g/100g; g/100g; g/100g 52000-013_149e60fd-1d2b-498e-9164-b37d82d91e5b 52000-013 HUMAN OTC DRUG Ice Cold Analgesic Gel Menthol and Camphor GEL TOPICAL 20130315 OTC MONOGRAPH FINAL part341 Universal Distribution Center LLC CAMPHOR (SYNTHETIC); MENTHOL .5; 1 g/100g; g/100g 52000-014_3c0cc40b-7e1b-46e6-ad44-33ff1f43d1bb 52000-014 HUMAN OTC DRUG Creamy Petroleum Jelly Petrolatum JELLY TOPICAL 20140819 OTC MONOGRAPH FINAL part347 Universal Distribution Center LLC PETROLATUM 30 g/100g 52000-015_08c4c494-1bf1-32ac-e054-00144ff88e88 52000-015 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20141122 OTC MONOGRAPH NOT FINAL part333E Universal Distribution Center LLC ALCOHOL 70 mL/100mL 52000-016_0929689b-d8e6-5f1e-e054-00144ff8d46c 52000-016 HUMAN OTC DRUG Instant Hand Sanitizer Aloe Vera Ethyl Alcohol LIQUID TOPICAL 20141122 OTC MONOGRAPH NOT FINAL part333E Universal Distribution Center LLC ALCOHOL 70 mL/100mL 52000-017_0929689b-d8f4-5f1e-e054-00144ff8d46c 52000-017 HUMAN OTC DRUG Instant Hand Sanitizer Lavender Ethyl Alcohol LIQUID TOPICAL 20141122 OTC MONOGRAPH NOT FINAL part333E Universal Distribution Center LLC ALCOHOL 70 mL/100mL 52000-018_0929689b-d905-5f1e-e054-00144ff8d46c 52000-018 HUMAN OTC DRUG Instant Hand Sanitizer Citrus Zest Ethyl Alcohol LIQUID TOPICAL 20141122 OTC MONOGRAPH NOT FINAL part333E Universal Distribution Center LLC ALCOHOL 70 mL/100mL 52003-011_ea38c8be-cee8-85b1-1825-5f00b5fba707 52003-011 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205817 Linde Canada LTD OXYGEN 995 mL/L 52003-016_0f9a4411-b7b8-6539-cc3c-1c11b07b3823 52003-016 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Linde Canada LTD NITROGEN 995 mL/L 52007-100_cffb27bf-e90b-4bcd-8652-c3ae1cc61e3c 52007-100 HUMAN OTC DRUG Sanitex MVP Foam Anti-Bacterial Triclosan SOAP TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part333E Vectair Systems, Inc. TRICLOSAN 3 mg/mL 52007-110_fb7ddb5c-cb18-4c24-a89b-664aaf9d40d9 52007-110 HUMAN OTC DRUG Sanitex MVP Liquid Anti-Bacterial Chloroxylenol SOAP TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part333E Vectair Systems, Inc. CHLOROXYLENOL 10 mg/mL 52007-140_3bc8783a-a243-48ed-ae33-16cada2f6084 52007-140 HUMAN OTC DRUG Sanitex MVP Instant-Hand Sanitizer Alcohol-Free Benzalkonium Chloride SOAP TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part333E Vectair Systems, Inc. BENZALKONIUM CHLORIDE 1 mg/mL 52007-200_8b711e71-638e-43ec-91ad-64c7b1a678e3 52007-200 HUMAN OTC DRUG Altair Hand Care System Foam Anti-Bacterial Hand Triclosan SOAP TOPICAL 20140428 OTC MONOGRAPH NOT FINAL part333E Vectair Systems, Inc. TRICLOSAN 3 mg/mL 52007-240_3e6a5319-2d19-4a2d-9f3c-eb0629ea02ee 52007-240 HUMAN OTC DRUG Altair Hand Care System Instant-Hand Sanitizer Alcohol-Free Benzalkonium Chloride SOAP TOPICAL 20140502 OTC MONOGRAPH NOT FINAL part333E Vectair Systems, Inc. BENZALKONIUM CHLORIDE 1 mg/mL 52015-080_dfc4d700-ac72-4585-bfc4-dff74ccc3e18 52015-080 HUMAN PRESCRIPTION DRUG Dificid fidaxomicin TABLET, FILM COATED ORAL 20110527 NDA NDA201699 Cubist Pharmaceuticals U.S. FIDAXOMICIN 200 mg/1 Macrolides [Chemical/Ingredient],Macrolide Antibacterial [EPC] 52019-001_6e390a81-11d0-48d6-b8b1-591efe1aac8a 52019-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20101001 UNAPPROVED MEDICAL GAS All-Med, Inc OXYGEN 99 L/100L 52030-773_700125b6-84e9-42b6-a43d-767be4d538db 52030-773 HUMAN OTC DRUG SaniFoam ALCOHOL AEROSOL, FOAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Genesan Systems ALCOHOL 620 mg/g 52030-783_a2c6f6b6-f7ed-47a2-9077-8e0bd8aefe81 52030-783 HUMAN OTC DRUG Hand Sanitizer Wipes ALCOHOL CLOTH TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Genesan Systems ALCOHOL 620 mg/g 52031-0875_dbf36949-ac4a-44e7-863b-e0bd23327bcf 52031-0875 HUMAN OTC DRUG Dettol First Aid Antiseptic Chloroxylenol SOLUTION TOPICAL 19890208 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser (UK) Ltd CHLOROXYLENOL 4.8 g/100mL 52033-001_426594cd-3665-4f6e-870e-70219780f0d1 52033-001 HUMAN OTC DRUG ESCA Hand Sanitizing Wipes Alcohol LIQUID TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part333 ESCA Tech, Inc. ALCOHOL 65 mL/100mL 52039-001_c62bdafb-778a-4455-a077-2794f2c11099 52039-001 HUMAN OTC DRUG NATURES PURITY Scented White Petrolatum OINTMENT TOPICAL 20120718 OTC MONOGRAPH FINAL part347 AMERICAN EAGLE STAR IMPORTS INC. PETROLATUM 99.9 g/100g 52053-0001_49ce2525-06df-4944-9362-8c4678b4d661 52053-0001 HUMAN OTC DRUG Sambucol Cold and Flu Relief Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20130326 UNAPPROVED HOMEOPATHIC PharmaCare US, Inc. BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; ZINC GLUCONATE 6; 6; 3; 12; 2 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 52053-0002_0c819edf-9990-4136-a269-1e7607f8e841 52053-0002 HUMAN OTC DRUG Sambucol Cold and Flu Night Time Syrup Byronia, Chamomilla, Gelsemium Sempervirens, Passiflora Incarnata, Sambucus Nigra, Silicea, Sulphur, Zincum Gluconicum, Water LIQUID ORAL 20130906 UNAPPROVED DRUG OTHER PharmaCare US, Inc. BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; SILICON DIOXIDE; SULFUR; ZINC GLUCONATE 6; 6; 6; 6; 4; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52054-215_aea10af7-6013-4173-b659-f2607fe466de 52054-215 HUMAN PRESCRIPTION DRUG DEXEDRINE DEXTROAMPHETAMINE SULFATE TABLET ORAL 20140701 ANDA ANDA090652 Amedra Pharmaceuticals LLC DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 52054-216_aea10af7-6013-4173-b659-f2607fe466de 52054-216 HUMAN PRESCRIPTION DRUG DEXEDRINE DEXTROAMPHETAMINE SULFATE TABLET ORAL 20140701 ANDA ANDA090652 Amedra Pharmaceuticals LLC DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 52054-330_40e56a96-dd17-11e3-8b68-0800200c9a66 52054-330 HUMAN PRESCRIPTION DRUG DARAPRIM pyrimethamine TABLET ORAL 19530123 NDA NDA008578 Amedra Pharmaceuticals LLC PYRIMETHAMINE 25 mg/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 52054-512_f991261e-e032-4eb5-b91f-69abce20b60c 52054-512 HUMAN PRESCRIPTION DRUG DEXEDRINE SPANSULE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 19760802 NDA NDA017078 Amedra Pharmaceuticals LLC DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 52054-513_f991261e-e032-4eb5-b91f-69abce20b60c 52054-513 HUMAN PRESCRIPTION DRUG DEXEDRINE SPANSULE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 19760802 NDA NDA017078 Amedra Pharmaceuticals LLC DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 52054-514_f991261e-e032-4eb5-b91f-69abce20b60c 52054-514 HUMAN PRESCRIPTION DRUG DEXEDRINE SPANSULE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 19760802 NDA NDA017078 Amedra Pharmaceuticals LLC DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 52054-550_d4bf6f20-f0a2-11e2-b778-0800200c9a66 52054-550 HUMAN PRESCRIPTION DRUG ALBENZA albendazole TABLET, FILM COATED ORAL 19960611 NDA NDA020666 Amedra Pharmaceuticals LLC ALBENDAZOLE 200 mg/1 Antihelminthic [EPC] 52054-803_99f664e6-fcc8-4dba-b968-6741caf50cb0 52054-803 HUMAN PRESCRIPTION DRUG Adrenaclick Epinephrine INJECTION SUBCUTANEOUS 20091125 NDA NDA020800 Amedra Pharmaceuticals LLC EPINEPHRINE .15 mg/.15mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52054-804_99f664e6-fcc8-4dba-b968-6741caf50cb0 52054-804 HUMAN PRESCRIPTION DRUG Adrenaclick Epinephrine INJECTION SUBCUTANEOUS 20091125 NDA NDA020800 Amedra Pharmaceuticals LLC EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52069-100_0de91c75-e18d-4f53-a3a9-4e1923c1760a 52069-100 HUMAN OTC DRUG Sofskin Petroleum White Petroleum JELLY TOPICAL 20100310 OTC MONOGRAPH FINAL part347 Nova Petroleum & Chemicals Corporation PETROLATUM 110 g/110g 52069-101_adab309b-f25f-47c4-8c8d-0bc328393c48 52069-101 HUMAN OTC DRUG Vaporizing Chest Rub Menthol Camphor Eucalyptus Oil GEL TOPICAL 20100310 OTC MONOGRAPH FINAL part341 Nova Petroleum & Chemicals Corporation CAMPHOR, (+/-)-; EUCALYPTUS OIL; MENTHOL 4.7; 1.1; 1.1 g/110g; g/110g; g/110g 52069-102_497e2c81-43cc-4f14-89b3-305a3c325d0a 52069-102 HUMAN OTC DRUG Sofskin Baby Mineral Oil OIL TOPICAL 20100310 OTC MONOGRAPH FINAL part347 Nova Petroleum & Chemicals Corporation MINERAL OIL 1 mL/mL 52069-103_d76fa296-06de-496f-97e1-d8d59bb45975 52069-103 HUMAN OTC DRUG Sofskin Baby White Petrolatum JELLY TOPICAL 20100310 OTC MONOGRAPH FINAL part347 Nova Petroleum & Chemicals Corporation PETROLATUM 225 g/225g 52069-104_123b71b8-1ca0-4f59-87b4-c35636577bb1 52069-104 HUMAN OTC DRUG Sofskin Ice Analgesic Menthol GEL TOPICAL 20100310 OTC MONOGRAPH FINAL part341 Nova Petroleum & Chemicals Corporation MENTHOL 2.27 g/227g 52072-001_1b05f2ed-306c-4916-b555-4e78d2449fca 52072-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070105 UNAPPROVED MEDICAL GAS Dressel Welding Supply, Inc. OXYGEN 992 L/1000L 52072-002_9d29996b-3e96-4f06-b4cf-00a3c3c081ba 52072-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen LIQUID RESPIRATORY (INHALATION) 20041223 UNAPPROVED MEDICAL GAS Dressel Welding Supply, Inc. OXYGEN 992 L/1000L 52072-003_af6cf958-c546-4c86-a2f6-08b33fcab0e5 52072-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20101209 UNAPPROVED MEDICAL GAS Dressel Welding Supply, Inc. NITROGEN 992 mL/L 52083-055_949494bd-9aa6-4c61-b06e-e67439fea278 52083-055 HUMAN OTC DRUG Supress DX Pediatric Drops Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SYRUP ORAL 20110329 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 50; 2.5 mg/mL; mg/mL; mg/mL 52083-056_51d2a65a-0c18-4966-8ab9-8265e4b92944 52083-056 HUMAN OTC DRUG SUPRESS-PE Pediatric Guiafenesin, Phenylephrine HCl SOLUTION/ DROPS ORAL 20140114 OTC MONOGRAPH FINAL part341 Kramer Novis GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 50; 2.5 mg/mL; mg/mL 52083-057_f2b99aa8-9a1a-4388-9b57-a385c561b706 52083-057 HUMAN OTC DRUG SUPRESS A Dexbromopheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SYRUP ORAL 20120801 OTC MONOGRAPH FINAL part341 Kramer Novis DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 10; 5 mg/mL; mg/mL; mg/mL 52083-058_e4c6e761-27c6-4453-9026-759ea0bba014 52083-058 HUMAN OTC DRUG Supress DM dextromethorphan hydrobromide, guaifenesin SYRUP ORAL 20131002 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 50 mg/mL; mg/mL 52083-231_4758f69f-d538-4258-9aef-3b112147af17 52083-231 HUMAN OTC DRUG Tussi Pres guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide SYRUP ORAL 20110328 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL 52083-232_f4ef1cfa-9ccf-4d9c-a438-d8770eb96165 52083-232 HUMAN OTC DRUG TUSSI PRES PEDIATRIC GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE SYRUP ORAL 20110324 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 75; 2.5 mg/5mL; mg/5mL; mg/5mL 52083-233_150bf86f-6e18-499c-bab4-5e8f9bf73380 52083-233 HUMAN OTC DRUG Tussi Pres guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide SYRUP ORAL 20110328 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL 52083-237_7fbc7d6b-f82a-4007-8d20-db7c0394752e 52083-237 HUMAN OTC DRUG Tussi Pres B dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride SYRUP ORAL 20110329 OTC MONOGRAPH FINAL part341 KRAMER NOVIS BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 20; 10 mg/5mL; mg/5mL; mg/5mL 52083-239_cf3a4857-ddd7-41ba-a347-b04895e98ab0 52083-239 HUMAN OTC DRUG TUSICOF dextromethorphan, guaifenesin, and phenylephrine SYRUP ORAL 20100817 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/5mL; mg/5mL; mg/5mL 52083-242_e9fb4163-0958-4473-ba07-394037bb2662 52083-242 HUMAN OTC DRUG Myco Nail A Antifungal Solution Undecylenic acid LIQUID TOPICAL 20140114 OTC MONOGRAPH FINAL part333C Kramer Novis UNDECYLENIC ACID 250 mg/mL 52083-249_eeeb8506-0c6d-4259-93dd-0744aa1fe17c 52083-249 HUMAN OTC DRUG Guaifenesin Phenylephrine Dextromethorphan Guaifenesin, phenylephrine HCL, Dextromethorphan TABLET, COATED ORAL 20120718 OTC MONOGRAPH FINAL part341 Kramer Novis. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/1; mg/1; mg/1 52083-289_6a9b9b21-64a8-4325-a6e2-d84a1b8ac28d 52083-289 HUMAN OTC DRUG Tusicof Guaifenesin, phenylephrine HCL, Dextromethorphan TABLET, COATED ORAL 20120718 OTC MONOGRAPH FINAL part341 Kramer Novis. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/1; mg/1; mg/1 52083-400_ca16687d-1b88-48f2-acc9-38ee125ae347 52083-400 HUMAN OTC DRUG ZYNCOF Dextromethorphan HBr and Guaifenesin SYRUP ORAL 20110601 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/5mL; mg/5mL 52083-481_6abb539d-677d-4ad9-9637-f8ed5bbeb58e 52083-481 HUMAN OTC DRUG Dologen Dexbrompheniramine Maleate, Acetaminophen TABLET ORAL 20111011 OTC MONOGRAPH FINAL part341 Kramer Novis ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE 650; 2 mg/1; mg/1 52083-482_ce40013e-1cfd-43fb-9ddc-045b46f0e279 52083-482 HUMAN OTC DRUG Dologen 325 Acetaminophen, Dexbrompheniramine TABLET ORAL 20140827 OTC MONOGRAPH FINAL part341 Kramer Novis ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE 325; 1 mg/1; mg/1 52083-600_f0ce44de-6405-4d1d-a431-31cc7492c890 52083-600 HUMAN OTC DRUG G-ZYNCOF Dextromethorphan HBr and Guaifenesin SYRUP ORAL 20121203 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/5mL; mg/5mL 52083-601_73d63dc1-4c0a-42cb-af2e-4f6815d89fd3 52083-601 HUMAN OTC DRUG G Tron Guaifenesin Dextromethorphan SYRUP ORAL 20120918 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 52083-602_cd027353-8669-4aac-b94f-d2ceb7456ef4 52083-602 HUMAN OTC DRUG G-P-TUSS DXP dexbrompheniramine, dextromethorphan, and phenylephrine SYRUP ORAL 20130124 OTC MONOGRAPH FINAL part341 Kramer Novis DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 20; 10 mg/5mL; mg/5mL; mg/5mL 52083-620_6d01b9b3-f258-4843-9a07-9627271cee67 52083-620 HUMAN OTC DRUG Pecgen DMX guaifenesin,Dextromethorphan hydrobromide SYRUP ORAL 20110329 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 15; 125 mg/5mL; mg/5mL 52083-622_9ea5374b-e7d7-4647-b99a-7eca40aecb0d 52083-622 HUMAN OTC DRUG Tusslin Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride SYRUP ORAL 20140701 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 28; 388; 10 mg/5mL; mg/5mL; mg/5mL 52083-623_21bcaf13-5dfa-40b4-b74b-169e27280fc3 52083-623 HUMAN OTC DRUG Tusslin Pediatric Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl SOLUTION/ DROPS ORAL 20140127 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 7.5; 88; 2.5 mg/mL; mg/mL; mg/mL 52083-625_09a988e4-f6a5-4c6c-bfce-0807629463a4 52083-625 HUMAN OTC DRUG ABATUSS DMX DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20140525 OTC MONOGRAPH FINAL part341 Kramer Novis DEXCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 15; 30 mg/5mL; mg/5mL; mg/5mL 52083-628_027d6dbd-3e19-4038-924c-925dceb48911 52083-628 HUMAN OTC DRUG PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20140808 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 187; 30 mg/5mL; mg/5mL; mg/5mL 52083-632_65c89c5f-8aeb-4d8e-9092-6b0a2cea2023 52083-632 HUMAN OTC DRUG Presgen guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide SYRUP ORAL 20110328 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL 52083-637_132984c0-5d7b-4971-a1e8-a4a1dcc20041 52083-637 HUMAN OTC DRUG Presgen B dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride SYRUP ORAL 20110329 OTC MONOGRAPH FINAL part341 KRAMER NOVIS BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 20; 10 mg/5mL; mg/5mL; mg/5mL 52083-639_e6cf0aff-a481-4eec-bc90-77f5412c83f8 52083-639 HUMAN OTC DRUG G-TUSICOF dextromethorphan, guaifenesin, and phenylephrine SYRUP ORAL 20120924 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/5mL; mg/5mL; mg/5mL 52083-641_c8298299-37cd-43d0-8514-592e11645226 52083-641 HUMAN OTC DRUG Desgen Pediatric Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl SOLUTION/ DROPS ORAL 20140127 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 50; 2.5 mg/mL; mg/mL; mg/mL 52083-645_35912503-cc63-476d-8078-42856d398ccd 52083-645 HUMAN OTC DRUG Desgen DM dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride SYRUP ORAL 20131002 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 100; 5 mg/5mL; mg/5mL; mg/5mL 52083-646_44763d19-83b8-4748-96b6-6e0b286c972e 52083-646 HUMAN OTC DRUG DESGEN DM Dextromethorphan HBr ,Guaifenesin ,Phenylephrine HCl SOLUTION ORAL 20141018 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 52083-653_bc93fc8b-940a-4755-a968-c11bf7e28a46 52083-653 HUMAN OTC DRUG PRESGEN PEDIATRIC GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE SYRUP ORAL 20110324 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 75; 2.5 mg/5mL; mg/5mL; mg/5mL 52083-655_2bea2903-0939-4a04-ac0d-f4913b6e0a24 52083-655 HUMAN OTC DRUG G-Supress DX Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SYRUP ORAL 20110329 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 50; 2.5 mg/mL; mg/mL; mg/mL 52083-660_ca3816c8-45a5-4f72-9649-3a36057a7097 52083-660 HUMAN OTC DRUG Sorbugen dextromethorphan hydrobromide, glycerol guaiacolate SYRUP ORAL 20141008 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 15; 150 mg/7.5mL; mg/7.5mL 52083-678_f75884fc-b31c-44cd-906e-bf905046879d 52083-678 HUMAN OTC DRUG G-TRON PED Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl SOLUTION ORAL 20140127 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 350; 10 mg/5mL; mg/5mL; mg/5mL 52083-679_fa63c384-2ba4-49bd-8d18-519356dbcdc9 52083-679 HUMAN OTC DRUG G-TRON PEDIATRIC DROPS Dextromethorphan HBr,Guaifenesin,Phenylephrine HCL SOLUTION/ DROPS NASAL 20140909 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/mL; mg/mL; mg/mL 52083-681_7789eec9-9622-418a-ab65-57b1f5f40ebd 52083-681 HUMAN OTC DRUG G-Dologen acetaminophen, dexbrompheniramine maleate TABLET ORAL 20140827 OTC MONOGRAPH FINAL part341 KRAMER NOVIS ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE 650; 2 mg/1; mg/1 52083-713_aa6eff15-6592-4199-b37b-bad0931ad2dd 52083-713 HUMAN OTC DRUG Gumsol Benzocaine, Zinc Chloride SOLUTION ORAL 20140228 OTC MONOGRAPH NOT FINAL part356 Kramer Novis BENZOCAINE; ZINC CHLORIDE 1.5; .03 g/30mL; g/30mL 52083-714_563ff687-4fe7-4f67-9669-26b0795b4882 52083-714 HUMAN OTC DRUG Gumsol Benzocaine, Zinc Chloride SPRAY ORAL 20140228 OTC MONOGRAPH NOT FINAL part356 Kramer Novis BENZOCAINE; ZINC CHLORIDE 1.5; .03 g/30mL; g/30mL 52084-0001_df120de1-bc45-434e-946b-9a5585fe0ad7 52084-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100105 UNAPPROVED MEDICAL GAS Morgan Medical Equipment & Supply OXYGEN 99 L/100L 52085-001_5d21586b-622f-4425-aad6-0bdfa251e721 52085-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20070401 UNAPPROVED MEDICAL GAS Analgesic Services Inc. dba ASI Medical OXYGEN 99 L/100L 52085-002_76cc375e-fdc8-4909-83d4-5e122c099c92 52085-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20131201 UNAPPROVED MEDICAL GAS Analgesic Services Inc. dba ASI Medical NITROGEN 99 L/100L 52087-0001_36a1dc4b-02ac-495e-b2af-2ab8c275de11 52087-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100224 UNAPPROVED MEDICAL GAS Legacy Durable Medical Equipment Inc OXYGEN 99 L/100L 52094-070_30f150a0-a126-4eef-bf7f-43582bbfe824 52094-070 HUMAN OTC DRUG AVOBENZONE, OCTINOXATE, TITANIUM DIOXIDE AVOBENZONE, OCTINOXATE, TITANIUM DIOXIDE LIPSTICK TOPICAL 20100329 OTC MONOGRAPH NOT FINAL part352 GRAFTON PRODUCTS CORP. AVOBENZONE; OCTINOXATE; TITANIUM DIOXIDE .048; .192; .041 g/3.2g; g/3.2g; g/3.2g 52096-001_e2397e82-8438-4998-9a98-812e5ee763e4 52096-001 HUMAN PRESCRIPTION DRUG PerioChip Chlorhexidine Gluconate INSERT, EXTENDED RELEASE PERIODONTAL 19980501 NDA NDA020774 Adrian Pharmaceuticals, LLC CHLORHEXIDINE GLUCONATE 2.5 mg/1 Decreased Cell Wall Integrity [PE] 52099-7005_ccc30ded-2bb9-41eb-bd2f-9f3d370b769a 52099-7005 HUMAN OTC DRUG footshield plus Tolnaftate CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part333C Q.A. Laboratories TOLNAFTATE 1 g/100g 52099-8000_a8c8b241-6d5d-476a-ad04-e9b73830116f 52099-8000 HUMAN OTC DRUG FREEZIN COLD TOAST METHYL SALICYLATE CREAM TOPICAL 20120612 OTC MONOGRAPH FINAL part348 Q.A. Laboratories MENTHOL; METHYL SALICYLATE 11; 31 g/100g; g/100g 52099-8005_2c7dc070-a6b5-4bb2-a9d4-b9b6c861e868 52099-8005 HUMAN OTC DRUG SCREAMIN HOT TOAST CAPSAICIN CREAM TOPICAL 20120619 OTC MONOGRAPH FINAL part348 Q.A. Laboratories CAPSAICIN 3 g/100g 52099-8010_e3e1bce6-42fe-45f2-8f34-a2be39dacbb3 52099-8010 HUMAN OTC DRUG SCREAMIN MENTHOL TOAST MENTHOL CREAM TOPICAL 20120621 OTC MONOGRAPH FINAL part348 Q.A. Laboratories MENTHOL 4 g/100g 52102-1001_8135482e-b382-4c77-ac02-b1a649837a8f 52102-1001 HUMAN OTC DRUG Kimchi Vitamin chewable multivitamin vitamin TABLET, CHEWABLE ORAL 20100318 UNAPPROVED DRUG OTHER Tobico ALPHA-TOCOPHEROL; ASCORBIC ACID; CHOLECALCIFEROL; COLLAGENASE; FOLIC ACID; LACTIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A 1.875; 180; .375; 5.625; .03; 30; .045; .285; .24; .195; .675 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 52105-070_c95b3173-da41-4cfa-8be0-38016e2f3805 52105-070 HUMAN OTC DRUG AVOBENZONE, OCTINOXATE, TITANIUM DIOXIDE AVOBENZONE, OCTINOXATE, TITANIUM DIOXIDE LIPSTICK TOPICAL 20100329 OTC MONOGRAPH NOT FINAL part352 CHROMAVIS SPA AVOBENZONE; OCTINOXATE; TITANIUM DIOXIDE .048; .192; .041 g/3.2g; g/3.2g; g/3.2g 52116-7100_e599e769-9299-4cc9-8374-9116cf62f589 52116-7100 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20110505 OTC MONOGRAPH NOT FINAL part333E MAC Medical Supply Company, Inc. BENZALKONIUM CHLORIDE 1.2478 g/L 52118-001_7bc0575c-0a78-4e3c-820c-f0bcc9f8c99f 52118-001 HUMAN PRESCRIPTION DRUG Vibativ telavancin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091105 NDA NDA022110 Theravance, Inc. TELAVANCIN HYDROCHLORIDE 15 mg/mL 52118-002_7bc0575c-0a78-4e3c-820c-f0bcc9f8c99f 52118-002 HUMAN PRESCRIPTION DRUG Vibativ telavancin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091105 NDA NDA022110 Theravance, Inc. TELAVANCIN HYDROCHLORIDE 15 mg/mL 52123-010_53946273-0e5b-4e0c-9d44-c29a931a5795 52123-010 HUMAN OTC DRUG PURE RED GINSENG CLEANSING Witch Hazel AEROSOL, FOAM TOPICAL 20120601 OTC MONOGRAPH FINAL part347 SOBAEK INSAM FARMING COOPERATIVE CORPORATION WITCH HAZEL .12 g/120mL 52123-020_849cca7e-4620-4de9-911b-7bcae0169b93 52123-020 HUMAN OTC DRUG PURE RED GINSENG Witch Hazel SOAP TOPICAL 20120601 OTC MONOGRAPH FINAL part347 SOBAEK INSAM FARMING COOPERATIVE CORPORATION WITCH HAZEL .1 g/100g 52123-030_5604f0e0-729a-4034-8bc1-0888b2bd1536 52123-030 HUMAN OTC DRUG Red Ginseng Pure Red Lively Water Allantoin CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part347 SOBAEK INSAM FARMING COOPERATIVE CORPORATION ALLANTOIN .25 g/50g 52123-040_0bd31cd5-7262-48ec-a5f8-66f9d543897e 52123-040 HUMAN OTC DRUG Red Ginseng Pure Red Classic Light Titanium Dioxide LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SOBAEK INSAM FARMING COOPERATIVE CORPORATION TITANIUM DIOXIDE 4 g/100g 52124-0001_e4f2d7c1-511f-4c61-b38c-567727801f1f 52124-0001 HUMAN OTC DRUG Antiseptic BENZALKONIUM CHLORIDE SWAB TOPICAL 20100423 OTC MONOGRAPH NOT FINAL part333A Genuine First Aid LLC BENZALKONIUM CHLORIDE 1.3 mg/mL 52124-0002_2adaeb86-8a58-477d-ba24-0e40a1496000 52124-0002 HUMAN OTC DRUG Alcohol Cleansing Pad ISOPROPYL ALCOHOL LIQUID TOPICAL 20100423 OTC MONOGRAPH NOT FINAL part333A Genuine First Aid LLC ISOPROPYL ALCOHOL 70 mL/100mL 52124-0003_696ebd38-f3de-4eab-9534-e229fac2bf86 52124-0003 HUMAN OTC DRUG Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE OINTMENT TOPICAL 20100216 OTC MONOGRAPH FINAL part333B Genuine First Aid LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [iU]/g; mg/g; [iU]/g 52124-0004_fbc705dd-eaf8-41cf-9f8b-59032951c9a7 52124-0004 HUMAN OTC DRUG Genuine First Aid Burn Antiseptic Pain Relief With Aloe BENZALKONIUM CHLORIDE, LIDOCAINE CREAM TOPICAL 20100423 OTC MONOGRAPH FINAL part333A Genuine First Aid BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .13; .5 g/100g; g/100g 52124-0005_c7bbb831-ecd8-4c13-8aa7-02c2b8f99f1f 52124-0005 HUMAN OTC DRUG Sterile Isotonic Buffered Genuine Eyewash WATER LIQUID OPHTHALMIC 20100216 OTC MONOGRAPH FINAL part349 Genuine First Aid WATER 98.16 mL/100mL 52124-0006_cc790eaf-f114-4c1f-95e0-87c49c741eef 52124-0006 HUMAN OTC DRUG Genuine Hand Sanitizer ALCOHOL GEL TOPICAL 20100423 OTC MONOGRAPH FINAL part333A Genuine First Aid LLC ALCOHOL 62 g/100g 52124-0007_9e4b519d-9710-474a-95bb-d7aa44c6aaf3 52124-0007 HUMAN OTC DRUG Hydrocortisone HYDROCORTISONE ACETATE CREAM TOPICAL 20100423 OTC MONOGRAPH FINAL part348 Genuine First Aid HYDROCORTISONE ACETATE 1 g/100g 52124-0008_b994d7dc-664e-4fdf-9b36-f3af79dbe6e5 52124-0008 HUMAN OTC DRUG Insect Sting Relief Pad BENZOCAINE,ALCOHOL SWAB TOPICAL 20100423 OTC MONOGRAPH FINAL part348 Genuine First Aid LLC ALCOHOL; BENZOCAINE 60; 6 mL/100mL; mL/100mL 52124-0009_11241349-aa1e-4083-86bb-5e5a675cdaff 52124-0009 HUMAN OTC DRUG Ibuprofen IBUPROFEN TABLET ORAL 20100217 ANDA ANDA075010 Genuine First Aid LLC IBUPROFEN 200 mg/1 52124-0010_2c1f58d1-64a9-4a63-8a89-2f29306c0069 52124-0010 HUMAN OTC DRUG NON-ASPIRIN ACETAMINOPHEN TABLET ORAL 20100423 OTC MONOGRAPH NOT FINAL part343 Genuine First Aid LLC ACETAMINOPHEN 325 mg/1 52124-0011_444b9707-2425-447e-858d-e2f1548becef 52124-0011 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET ORAL 20100423 OTC MONOGRAPH FINAL part343 Genuine First Aid LLC ASPIRIN 325 mg/1 52124-0012_babc96b5-fffd-41e1-9a6a-ee7876eff00a 52124-0012 HUMAN OTC DRUG Chewable Aspirin ASPIRIN TABLET, CHEWABLE ORAL 20100402 OTC MONOGRAPH FINAL part343 Genuine First Aid LLC ASPIRIN 81 mg/1 52124-0101_bd6f97ab-5ec5-410a-b95b-b252cdbd745c 52124-0101 HUMAN OTC DRUG GFA 42 Essential First Aid Items ISOPROPYL ALCOHOL KIT 20100429 OTC MONOGRAPH FINAL part345 Genuine First Aid LLC 52124-0102_6d3dcefe-c7d8-4eeb-bdd7-23d917db18d2 52124-0102 HUMAN OTC DRUG FIRST AID Contains 101 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN KIT 20100424 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC 52124-0103_6d2ed56c-dcca-441e-af47-d383cc5e4eb2 52124-0103 HUMAN OTC DRUG FIRST AID Contains 101 PIECES HARDCASE BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN KIT 20100424 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC 52124-0105_d47bffdf-e2de-4085-8421-25e98c7d534a 52124-0105 HUMAN OTC DRUG FIRST AID Contains 303 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN KIT 20100424 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC 52124-0106_3d79ae08-e940-4685-8ed1-a2a3bdf213a2 52124-0106 HUMAN OTC DRUG FIRST AID Contains 303 PIECES HARDCASE BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOTROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN KIT 20100428 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC 52124-0107_7e2f8c52-dae3-4e68-84b9-0e7701c46118 52124-0107 HUMAN OTC DRUG FIRST AID Contains 404 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOTROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN KIT 20100425 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC 52124-0109_3ee9f2db-5340-48a9-8333-c1083135d565 52124-0109 HUMAN OTC DRUG GENUINE FIRST AID Emergency Preparedness Contains 167 Pieces BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN, KIT 20100514 OTC MONOGRAPH FINAL part345 Genuine First Aid LLC 52124-0110_fa2e3b78-659e-4e54-a9a5-88d8598fa671 52124-0110 HUMAN OTC DRUG GENUINE FIRST AID Emergency Preparedness Contains 167 PIECES HARDCASE BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN KIT 20100428 OTC MONOGRAPH FINAL part345 Genuine First Aid LLC 52124-0111_fd9dd0ed-a7e0-44c8-9c21-4b03b32f8cad 52124-0111 HUMAN OTC DRUG 10 Person ANSI BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN KIT 20100424 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC 52124-0112_3db06e79-e87f-4e44-ac20-c692118b932e 52124-0112 HUMAN OTC DRUG 25 Person ANSI BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN, ISOPROPYL ALCOHOL KIT 20100425 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC 52124-0113_2a883d44-4542-4a0e-8202-6a70e159ee52 52124-0113 HUMAN OTC DRUG 50 Person ANSI BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN, ISOPROPYL ALCOHOL KIT 20100602 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC 52124-0114_494c6e04-0310-483d-9d34-bd46dc804aff 52124-0114 HUMAN OTC DRUG Protection ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN KIT 20100423 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC 52124-0115_eed408f2-0c94-4432-819f-381b88724a08 52124-0115 HUMAN OTC DRUG Emergency Preparedness BENZALKONIUM CHLORIDE,BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE, ETHYL ALCOHOL KIT 20100423 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC 52124-0116_27826c7e-54b3-47bb-ab49-d58dac48fb63 52124-0116 HUMAN OTC DRUG Small Cuts and Burns BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE KIT 20100423 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC 52124-0117_d1e32dcf-dca4-450c-b27e-226352540381 52124-0117 HUMAN OTC DRUG Medium Cuts and Scratches BENZALKONIUM CHLORIDE, WATER KIT 20100423 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC 52124-0118_91aa1891-7ebd-49e8-b874-e0b550b09bd6 52124-0118 HUMAN OTC DRUG Auto 157 BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN KIT 20100507 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC 52124-1000_63082ebc-35d7-4171-b4d3-5f0d76b217f7 52124-1000 HUMAN OTC DRUG Genuine First Aid - Auto First Aid BENZALKONIUM CHLORIDE, IBUPROFEN, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN KIT 20110111 OTC MONOGRAPH NOT FINAL part333E Genuine First Aid, LLC 52124-1023_a514e24f-246f-4eae-98fc-71a80c66df04 52124-1023 HUMAN OTC DRUG GFA First Aid Kit Essentials - 33 Pieces ASPIRIN, IBUPROFEN, ACETAMINOPHEN, ALCOHOL, BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE KIT 20110818 OTC MONOGRAPH NOT FINAL part333B Genuine First Aid, LLC 52124-1154_f1c6e667-8c30-4519-a961-98546c966463 52124-1154 HUMAN OTC DRUG GFA First Aid 75 Person Metal Case BENZALKONIUM CHLORIDE, BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE, POVIDONE-IODINE, WATER, ALCOHOL, ASPIRIN, IBUPROFEN, ACETAMINOPHEN, BENZOCAINE, ALCOHOL KIT 20110503 OTC MONOGRAPH FINAL part333E Genuine First Aid, LLC 52124-1164_6b08d42c-5fa6-48b8-9a61-52d8c8145f99 52124-1164 HUMAN OTC DRUG GFA First Aid BENZALKONIUM CHLORIDE, BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B KIT 20110413 OTC MONOGRAPH FINAL part333E Genuine First Aid, LLC 52124-1165_18cdc495-5dca-4b22-98f8-3f709c228bc5 52124-1165 HUMAN OTC DRUG GFA First Aid 16 Unit Metal Case BENZALKONIUM CHLORIDE, BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B KIT 20110503 OTC MONOGRAPH FINAL part333E Genuine First Aid, LLC 52124-1166_da4c53fb-cb3b-4efa-a402-03b644217945 52124-1166 HUMAN OTC DRUG GFA First Aid 24 Unit Metal Case BENZALKONIUM CHLORIDE, BENZALKONIUM CHLORIDE, LIDOCAINE, POVIDONE-IODINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B KIT 20110503 OTC MONOGRAPH FINAL part333E Genuine First Aid, LLC 52124-1167_e1829c88-e16f-40e5-9cd9-3fd62e0004f4 52124-1167 HUMAN OTC DRUG GFA First Aid 36 Unit Metal Case BENZALKONIUM CHLORIDE, BENZALKONIUM CHLORIDE, LIDOCAINE, POVIDONE-IODINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B KIT 20110504 OTC MONOGRAPH FINAL part333E Genuine First Aid, LLC 52124-1200_aca196dc-cdfb-4702-a04d-72a81b70d4d7 52124-1200 HUMAN OTC DRUG Genuine First Aid - Home First Aid BENZALKONIUM CHLORIDE, IBUPROFEN, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN KIT 20110111 OTC MONOGRAPH NOT FINAL part333E Genuine First Aid, LLC 52124-2901_832bed96-a18f-47af-8b24-848a267eee5b 52124-2901 HUMAN OTC DRUG Povidone-Iodine Prep POVIDONE-IODINE SWAB TOPICAL 20110404 OTC MONOGRAPH NOT FINAL part333E Genuine First Aid, LLC POVIDONE-IODINE 1 mL/100mL 52124-2903_e83702cb-1a10-4c78-b809-c0341cc507d0 52124-2903 HUMAN OTC DRUG Genuine Hydrocortisone HYDROCORTISONE CREAM TOPICAL 20110329 OTC MONOGRAPH NOT FINAL part348 Genuine First Aid, LLC HYDROCORTISONE ACETATE 1 g/100g 52124-2906_12fe8e70-3376-4bd4-9239-4eafc393db76 52124-2906 HUMAN OTC DRUG Genuine Hand Sanitizer ALCOHOL GEL TOPICAL 20110328 OTC MONOGRAPH NOT FINAL part333A Genuine First Aid, LLC ALCOHOL 62 g/100g 52124-3201_f155deda-b928-428a-b570-79d5d556b217 52124-3201 HUMAN OTC DRUG Ammonia Pad AMMONIA INHALANT RESPIRATORY (INHALATION) 20110404 UNAPPROVED DRUG OTHER Genuine First Aid, LLC AMMONIA 10 mL/100mL 52124-4001_c5160f28-9ec8-4ea0-b7de-30e215a4f371 52124-4001 HUMAN OTC DRUG Ready America First Aid Pocket - 33 Pieces ASPIRIN, IBUPROFEN, ACETAMINOPHEN, ALCOHOL, BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE KIT 20130109 OTC MONOGRAPH NOT FINAL part333B Genuine First Aid, LLC 52124-4002_9cd0d6a7-8614-4eaf-96ea-d42eb5f97098 52124-4002 HUMAN OTC DRUG Ready America First Aid Outdoor- 107 Pieces ASPIRIN, IBUPROFEN, ACETAMINOPHEN, ALCOHOL, BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL KIT 20130109 OTC MONOGRAPH NOT FINAL part333B Genuine First Aid, LLC 52124-4016_3a45ef1e-0890-4c9f-a8b7-f3ecc8730bfe 52124-4016 HUMAN OTC DRUG Genuine First Aid Industrial First Aid ASPIRIN, ACETAMINOPHEN, IBUPROFEN, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, BENZALKONIUM CHLORIDE, LIDOCAINE, BENZALKONIUM CHLORIDE KIT 20110503 OTC MONOGRAPH FINAL part333E Genuine First Aid, LLC 52125-001_bb5e7a8a-a7d8-46a5-8d66-9231aa4d9bf6 52125-001 HUMAN PRESCRIPTION DRUG Vistaril hydroxyzine pamoate CAPSULE ORAL 20130311 NDA NDA011459 REMEDYREPACK INC. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 52125-002_157c5414-3672-40af-8ba0-911219292a4c 52125-002 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20130403 ANDA ANDA062396 REMEDYREPACK INC. DOXYCYCLINE HYCLATE 100 mg/1 52125-002_e1f81f10-31dd-4527-825b-34fb00dae767 52125-002 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20130227 ANDA ANDA062396 REMEDYREPACK INC. DOXYCYCLINE HYCLATE 100 mg/1 52125-003_7cadb730-8020-4e1d-bb23-32c175f451a9 52125-003 HUMAN PRESCRIPTION DRUG DARAPRIM pyrimethamine TABLET ORAL 20130226 NDA NDA008578 REMEDYREPACK INC. PYRIMETHAMINE 25 mg/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 52125-005_f3f606da-940f-4854-af7f-08cc699ef8fd 52125-005 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium GRANULE ORAL 20130226 NDA NDA021409 REMEDYREPACK INC. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 52125-006_65f6df25-0ce5-42d7-b3b9-86faf752c826 52125-006 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium GRANULE ORAL 20130301 NDA NDA021409 REMEDYREPACK INC. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 52125-007_0ce9b855-ba70-4f90-aee1-d8b76554a45d 52125-007 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20130225 ANDA ANDA075536 REMEDYREPACK INC. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-007_205b08bf-17f0-4d5d-b10f-e4df3ea0883a 52125-007 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20130708 ANDA ANDA075536 REMEDYREPACK INC. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-008_b8a33b44-5308-4aaa-8576-7199d118f6c8 52125-008 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20120816 ANDA ANDA090035 REMEDYREPACK INC. FOLIC ACID 1 mg/1 52125-011_e3b0c38a-4f06-47be-869f-45aa30b118f2 52125-011 HUMAN PRESCRIPTION DRUG SELZENTRY maraviroc TABLET, FILM COATED ORAL 20130218 NDA NDA022128 REMEDYREPACK INC. MARAVIROC 150 mg/1 CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] 52125-012_6ac7c076-11f0-4d5d-906b-6b9ce2ebc0e1 52125-012 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET ORAL 20130309 ANDA ANDA078939 REMEDYREPACK INC. ETHAMBUTOL HYDROCHLORIDE 100 mg/1 Antimycobacterial [EPC] 52125-013_644774b7-4e5c-4486-ae45-8b5f9e8ca9e3 52125-013 HUMAN PRESCRIPTION DRUG Pyrazinamide Pyrazinamide TABLET ORAL 20130226 ANDA ANDA081319 REMEDYREPACK INC. PYRAZINAMIDE 500 mg/1 Antimycobacterial [EPC] 52125-014_13c5cd13-8005-4689-9acd-e8ea5191176f 52125-014 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20120816 ANDA ANDA087056 REMEDYREPACK INC. CYPROHEPTADINE 4 mg/1 52125-015_c1cc499c-f4a1-4d47-be18-e0f169ecfca6 52125-015 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20130329 ANDA ANDA202050 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 52125-016_a7e86c34-8408-4278-8e11-687a774cd6fe 52125-016 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20130328 ANDA ANDA202032 REMEDYREPACK INC. LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 52125-017_9a0928b6-6cb9-4643-978f-4b45fad56067 52125-017 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130227 ANDA ANDA077630 REMEDYREPACK INC. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-018_d803439c-fde5-4729-9485-4eb25f3ab846 52125-018 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 20130927 ANDA ANDA071198 REMEDYREPACK INC. LEUCOVORIN CALCIUM 5 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 52125-019_6254fd15-a263-4909-b6de-c138da7bcd28 52125-019 HUMAN PRESCRIPTION DRUG cyclobenzaprine hydrochloride cyclobenzaprine hydrochloride TABLET ORAL 20130225 ANDA ANDA077563 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 52125-020_5584e8cd-0961-42eb-b37f-fd7cfc098d59 52125-020 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 20130305 NDA NDA050730 REMEDYREPACK INC. AZITHROMYCIN, UNSPECIFIED FORM 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-021_2d6a9d73-f7bd-4af2-92bc-6a6dc04276dd 52125-021 HUMAN PRESCRIPTION DRUG Methylergonovine Maleate Methylergonovine Maleate TABLET ORAL 20130225 ANDA ANDA091577 REMEDYREPACK INC. METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 52125-022_725dd0a0-5b9d-4c5d-803b-b8be27b9feba 52125-022 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20130225 ANDA ANDA076745 REMEDYREPACK INC. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52125-024_29719313-e199-4470-b6d9-0ed03997924f 52125-024 HUMAN PRESCRIPTION DRUG Robaxin Methocarbamol TABLET ORAL 20120816 NDA NDA011011 REMEDYREPACK INC. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 52125-025_f7ba3875-167f-45ab-8382-3b70349ae9db 52125-025 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20130225 ANDA ANDA077657 REMEDYREPACK INC. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 52125-028_2e665f67-0cd1-4d13-9d1b-ed0378f4d5aa 52125-028 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20130225 ANDA ANDA077856 REMEDYREPACK INC. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 52125-029_9a3988d7-14ba-4831-82bd-d0b164e66fb6 52125-029 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20130218 ANDA ANDA074569 REMEDYREPACK INC. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 52125-030_ed0f48c0-fe15-468a-bced-f457f869e025 52125-030 HUMAN PRESCRIPTION DRUG Lorazepam LORAZEPAM TABLET ORAL 20120820 ANDA ANDA072926 REMEDYREPACK INC. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52125-031_e4d2b32d-b885-4ba2-afa0-be499ed2b966 52125-031 HUMAN PRESCRIPTION DRUG Lorazepam LORAZEPAM TABLET ORAL 20120820 ANDA ANDA072926 REMEDYREPACK INC. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52125-032_04bb04be-f66c-43e9-bb10-5544442281ed 52125-032 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20130225 ANDA ANDA077534 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-033_33ea30f3-3d4e-44e7-b392-715c0b5d99f9 52125-033 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20130227 NDA NDA021366 REMEDYREPACK INC. ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52125-034_77924702-57b6-4f55-a1c5-eca0ca45334e 52125-034 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20120820 ANDA ANDA040256 REMEDYREPACK INC. PREDNISONE 5 mg/1 52125-035_deed5429-0606-4333-a71d-748b05e16a16 52125-035 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20130226 ANDA ANDA078060 REMEDYREPACK INC. SULFAMETHOXAZOLE 800 mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA] 52125-036_e1311404-063c-4c97-807c-322b5a6e7e68 52125-036 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20130304 NDA NDA020405 REMEDYREPACK INC. DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 52125-037_05fceccf-80ef-4c35-904c-88a42be49cb1 52125-037 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20130227 ANDA ANDA073618 REMEDYREPACK INC. CARBIDOPA 25 mg/1 52125-038_6b6ad229-4543-42d4-969e-05237f6b6ac8 52125-038 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20120820 ANDA ANDA070925 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 52125-039_22d62b1b-6127-4977-9417-5604ffb95ee7 52125-039 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 20130226 ANDA ANDA071839 REMEDYREPACK INC. MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 52125-040_f0dace5a-1b54-44d4-9ed5-60651e925992 52125-040 HUMAN PRESCRIPTION DRUG Zoloft SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130225 NDA NDA019839 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-041_bc26543c-6b46-470e-89b2-b63f9fc36ce9 52125-041 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20120828 ANDA ANDA074056 REMEDYREPACK INC. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-042_b32ea69e-2037-4988-b1ec-7b8fcfe3ac76 52125-042 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20130225 ANDA ANDA075465 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-043_dd7af4de-526c-49b2-9688-20804de5fc11 52125-043 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20130228 NDA NDA021035 REMEDYREPACK INC. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-044_4d4be82b-6ecb-4c95-b8d7-166231635b39 52125-044 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20130410 NDA NDA021402 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-045_c14252d2-d4e4-49d7-9048-840b40795a3f 52125-045 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20130314 NDA NDA018413 REMEDYREPACK INC. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 52125-046_d65eddcf-00f9-4fe8-8b82-acd6b70185de 52125-046 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET ORAL 20130301 ANDA ANDA090844 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 52125-047_31ebd1da-236c-467e-90cd-85d4b368854a 52125-047 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20130401 ANDA ANDA079153 REMEDYREPACK INC. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-048_8a7e56e7-84c3-4eb2-b8b4-2519249ea530 52125-048 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130228 ANDA ANDA078445 REMEDYREPACK INC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 52125-049_0742a0fb-057b-4208-888f-5ae1f90631a2 52125-049 HUMAN PRESCRIPTION DRUG Erythromycin Base Base Erythromycin TABLET, FILM COATED ORAL 20131231 ANDA ANDA061621 REMEDYREPACK INC. ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-049_27547b52-4aa4-4890-a014-710a77c6a65d 52125-049 HUMAN PRESCRIPTION DRUG Erythromycin Base Base Erythromycin TABLET, FILM COATED ORAL 20130314 ANDA ANDA061621 REMEDYREPACK INC. ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-050_e686dfc2-1d0c-442e-962e-0d38e2922f5e 52125-050 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20130314 ANDA ANDA070581 REMEDYREPACK INC. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 52125-051_702fa0ea-4d93-40f8-9d79-8f0314c0a6d3 52125-051 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20130308 NDA AUTHORIZED GENERIC NDA019962 REMEDYREPACK INC. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-052_16c1959d-f863-4caf-bea2-25b215923cdb 52125-052 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20130314 ANDA ANDA075978 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-053_edf8930e-9b1a-49ba-9504-bb073d2ba940 52125-053 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20130228 NDA NDA009218 REMEDYREPACK INC. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-054_be7073e7-7111-4776-b2d6-f8f7c70ea5bc 52125-054 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20120912 ANDA ANDA085161 REMEDYREPACK INC. PREDNISONE 20 mg/1 52125-055_d61c6735-f399-4bfa-ba97-730ea61fb409 52125-055 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET ORAL 20120912 ANDA ANDA040268 REMEDYREPACK INC. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-057_3674f658-31b9-48ac-9b00-54763d16a24a 52125-057 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20130220 ANDA ANDA077166 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-058_466e1d45-9701-43e6-88b9-0ac74fd53d67 52125-058 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 20130529 ANDA ANDA084285 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52125-058_699a0ac5-260c-4b6a-827e-56247ed7e531 52125-058 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 20140827 ANDA ANDA084285 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52125-058_7be1629e-c127-4991-8036-c70860142f25 52125-058 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 20130309 ANDA ANDA084285 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52125-059_b18d0f10-3f0f-4efa-9605-2072b2934cfc 52125-059 HUMAN PRESCRIPTION DRUG Isosorbide ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20120917 ANDA ANDA076813 REMEDYREPACK INC. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 52125-060_c8ab93b6-f4f4-44d4-93d4-bfef208fe345 52125-060 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20130308 ANDA ANDA201043 REMEDYREPACK INC. LEVOFLOXACIN 250 mg/1 52125-061_4c783578-936b-4184-af23-453114505d8b 52125-061 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20130226 ANDA ANDA077627 REMEDYREPACK INC. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-062_52e9802f-4f1d-4286-a3f2-7a3addea7d74 52125-062 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20130221 ANDA ANDA083386 REMEDYREPACK INC. CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-063_babdbc1a-2960-4e1c-b3c0-5ddb52532d69 52125-063 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130226 ANDA ANDA075752 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-064_58c40b70-5872-4653-9676-aeed89dc108f 52125-064 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20130308 NDA AUTHORIZED GENERIC NDA019962 REMEDYREPACK INC. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-065_59308d7c-6521-48ab-81eb-1c3746828586 52125-065 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20130222 NDA NDA021402 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-067_484175fd-dfac-4233-8645-1c56edb103db 52125-067 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20130222 NDA NDA021153 REMEDYREPACK INC. ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 52125-068_8ac561fd-af0e-4122-91d2-842969afd224 52125-068 HUMAN PRESCRIPTION DRUG Zithromax azithromycin TABLET, FILM COATED ORAL 20130312 NDA NDA050711 REMEDYREPACK INC. AZITHROMYCIN, UNSPECIFIED FORM 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-069_d9235122-e387-48c3-b17b-5a2c808899ac 52125-069 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20130314 ANDA ANDA076558 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-070_ec495c36-9e37-425c-956e-001cb011b16e 52125-070 HUMAN PRESCRIPTION DRUG Diamox Sequels Acetazolamide CAPSULE, EXTENDED RELEASE ORAL 20130221 NDA NDA012945 REMEDYREPACK INC. ACETAZOLAMIDE 500 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 52125-071_5f1d6207-73e6-43ec-9684-7661032bd512 52125-071 HUMAN PRESCRIPTION DRUG Norvasc AMLODIPINE BESYLATE TABLET ORAL 20130304 NDA NDA019787 REMEDYREPACK INC. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-072_fc6822f1-3d50-4cfe-9204-ed64d80458a1 52125-072 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20130222 NDA NDA021402 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-073_70a00372-bc17-4d81-842f-4e2fae4c3e16 52125-073 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20130314 ANDA ANDA040103 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 52125-074_a33dd76d-481d-454f-9f88-f61fe0666ebf 52125-074 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20130221 ANDA ANDA018659 REMEDYREPACK INC. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 52125-075_06019798-6ce9-44ea-9889-a1b932b02b06 52125-075 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20130401 NDA NDA009218 REMEDYREPACK INC. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-076_3133c058-17cd-4ad5-9822-fbad888778ae 52125-076 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20130314 ANDA ANDA075536 REMEDYREPACK INC. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-076_d07294c2-8807-43f3-951a-6e4a859a9081 52125-076 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20130708 ANDA ANDA075536 REMEDYREPACK INC. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-077_0786d64a-88bb-4e09-9141-f5b4fa83afbc 52125-077 HUMAN PRESCRIPTION DRUG Neurontin gabapentin CAPSULE ORAL 20120917 NDA NDA020235 REMEDYREPACK INC. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-078_04207c7a-24d0-4e8e-8959-f5dd48c7f998 52125-078 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20130315 ANDA ANDA073589 REMEDYREPACK INC. CARBIDOPA 25 mg/1 52125-079_2528d4a4-cdf9-4e38-92c8-b5d0e06a1a34 52125-079 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20130401 NDA NDA009218 REMEDYREPACK INC. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-080_6d5c2663-c3c5-4e07-93cd-828da890071b 52125-080 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20130226 NDA NDA009218 REMEDYREPACK INC. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-081_4252a068-5613-40a8-bc31-be117ee79a33 52125-081 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20130222 ANDA ANDA074229 REMEDYREPACK INC. NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-082_0c242795-1cce-4a30-ba39-124b8ea37cfa 52125-082 HUMAN PRESCRIPTION DRUG TAPAZOLE methimazole TABLET ORAL 20130218 ANDA ANDA040320 REMEDYREPACK INC. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 52125-083_18bbd02f-77e1-44c3-9228-8d932f9356c9 52125-083 HUMAN PRESCRIPTION DRUG Colcrys Colchicine TABLET, FILM COATED ORAL 20130221 NDA NDA022352 REMEDYREPACK INC. COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 52125-084_15883375-bdde-4e7c-9731-dbbd61f1991c 52125-084 HUMAN PRESCRIPTION DRUG Feldene piroxicam CAPSULE ORAL 20120926 NDA NDA018147 REMEDYREPACK INC. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-085_b2f310a2-a994-4d40-8abd-2c0f09ba0bca 52125-085 HUMAN PRESCRIPTION DRUG Hectorol doxercalciferol CAPSULE, LIQUID FILLED ORAL 20120920 NDA NDA020862 REMEDYREPACK INC. DOXERCALCIFEROL .5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] 52125-086_4ca47eab-b8c6-49bc-b1f8-6e916d9a16ef 52125-086 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 20130315 ANDA ANDA075273 REMEDYREPACK INC. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 52125-087_1971ee9a-2df0-4684-9956-295f97d76f70 52125-087 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130222 ANDA ANDA078525 REMEDYREPACK INC. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 52125-088_837444f7-40ba-4299-a922-eb5a8ee5d0fc 52125-088 HUMAN PRESCRIPTION DRUG Oxcarbazepine oxcarbazepine TABLET, FILM COATED ORAL 20130221 ANDA ANDA090239 REMEDYREPACK INC. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-089_8ece4450-cefb-47e1-8d05-48f6e98eb24d 52125-089 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20130308 ANDA ANDA077627 REMEDYREPACK INC. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-090_798fce44-5a29-476a-864d-09072987618a 52125-090 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20120920 ANDA ANDA078787 REMEDYREPACK INC. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-091_05cba71d-c62f-49fe-8c5b-999051c4df4a 52125-091 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20130304 NDA NDA009218 REMEDYREPACK INC. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-092_97aaf015-9404-4ede-ac4c-58d0da81ad4c 52125-092 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20130311 ANDA ANDA075479 REMEDYREPACK INC. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 52125-093_5f61a15d-b23e-4774-832c-8fbcf8c3e8dc 52125-093 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20130305 ANDA ANDA076288 REMEDYREPACK INC. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 52125-094_0b6b1955-e631-49e1-b9a6-99d3993937a1 52125-094 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20130329 ANDA ANDA075978 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-095_44ce50de-a030-414d-ad1b-1b1b3b53b534 52125-095 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE Acetazolamide TABLET ORAL 20130311 ANDA ANDA084840 REMEDYREPACK INC. ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 52125-096_181b5ee4-e67c-4d57-a3e6-fc469002ff70 52125-096 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20130222 ANDA ANDA073618 REMEDYREPACK INC. CARBIDOPA 10 mg/1 52125-097_8fce0b9d-84b8-42ed-8dd2-77da67193012 52125-097 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20130304 NDA NDA009218 REMEDYREPACK INC. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-098_8141572d-2323-423c-ade6-3994d51ddad2 52125-098 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE ORAL 20120921 NDA NDA018279 REMEDYREPACK INC. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 52125-099_1c176aab-5abe-4db0-b533-37b38246aaa5 52125-099 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20130301 NDA NDA009218 REMEDYREPACK INC. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-100_536fef5d-e98f-461f-abe8-80d46b0886df 52125-100 HUMAN PRESCRIPTION DRUG Gemfibrozil GEMFIBROZIL TABLET ORAL 20120921 ANDA ANDA074256 REMEDYREPACK INC. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 52125-101_9edeede1-b212-4805-8716-a6c51141cdc5 52125-101 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20130220 NDA NDA021402 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-102_978d4f5f-ec63-4bf9-8cc9-ba6c2c12c6c4 52125-102 HUMAN PRESCRIPTION DRUG Perphenazine PERPHENAZINE TABLET, FILM COATED ORAL 20120926 ANDA ANDA089684 REMEDYREPACK INC. PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-103_012612ef-a56d-42d4-a0c6-0004f4a4ff7a 52125-103 HUMAN PRESCRIPTION DRUG Biaxin Clarithromycin TABLET, FILM COATED ORAL 20130225 NDA NDA050662 REMEDYREPACK INC. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 52125-104_4abc903a-470a-4c35-b6bc-64e44f51ccc6 52125-104 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130315 ANDA ANDA074984 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52125-105_8d53cfe3-90ab-4d3d-af30-7f7c3a94b881 52125-105 HUMAN PRESCRIPTION DRUG Glipizide GLIPIZIDE TABLET ORAL 20120924 ANDA ANDA074305 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-106_a614d8af-6d63-408a-9cef-c487502bf40e 52125-106 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride PROPRANOLOL HYDROCHLORIDE TABLET ORAL 20120924 ANDA ANDA070213 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-107_b4dac2a1-a308-43c4-9484-4127f68ea9c3 52125-107 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130325 ANDA ANDA076373 REMEDYREPACK INC. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-108_37b16cc9-9bdd-462a-a512-697e92858edc 52125-108 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130305 ANDA ANDA078251 REMEDYREPACK INC. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-110_3aa5456c-f0d4-4e07-9728-5f9c44139227 52125-110 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20130329 ANDA ANDA076119 REMEDYREPACK INC. MIRTAZAPINE 45 mg/1 52125-111_6ff247e0-9373-4b79-80e4-d394a4c55e81 52125-111 HUMAN PRESCRIPTION DRUG TOPROLXL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20131004 NDA NDA019962 REMEDYREPACK INC. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-111_f0c56737-ea03-494c-83db-eb3f6cf3530a 52125-111 HUMAN PRESCRIPTION DRUG TOPROLXL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20130308 NDA NDA019962 REMEDYREPACK INC. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-112_f0809211-9de9-4666-9fcf-88fcd8f462e0 52125-112 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20130226 ANDA ANDA075465 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-113_8b246a89-1f2b-4402-af00-d68afa2c4f28 52125-113 HUMAN PRESCRIPTION DRUG Methyldopa METHYLDOPA TABLET ORAL 20120925 ANDA ANDA070098 REMEDYREPACK INC. METHYLDOPA 250 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 52125-114_3e7db94f-435f-44a3-91b0-95fde845225c 52125-114 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20130315 ANDA ANDA078459 REMEDYREPACK INC. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-115_b85f461e-5d1a-49e7-93fc-df108d7132be 52125-115 HUMAN PRESCRIPTION DRUG Synthroid LEVOTHYROXINE SODIUM TABLET ORAL 20120927 NDA NDA021402 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-116_d81accf1-467c-4b24-9428-9beac29b416e 52125-116 HUMAN PRESCRIPTION DRUG Synthroid LEVOTHYROXINE SODIUM TABLET ORAL 20120927 NDA NDA021402 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-117_28251998-5c4c-4df4-8e17-f63551891ef5 52125-117 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130228 ANDA ANDA079132 REMEDYREPACK INC. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 52125-118_6692ac13-df9f-4d8d-b720-0fca59fe3da2 52125-118 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120927 ANDA ANDA040209 REMEDYREPACK INC. TRIFLUOPERAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-119_b1b5d6c3-83d9-4abb-8875-626f29dbfdf9 52125-119 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130402 ANDA ANDA076373 REMEDYREPACK INC. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-120_eea4b5d0-0d33-4037-aa53-f34a5a944097 52125-120 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20130318 NDA NDA016620 REMEDYREPACK INC. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 52125-121_42277d0d-c4d0-4d65-aad3-e18336e6a2d0 52125-121 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20130329 NDA NDA021402 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-122_872e29af-5e70-47bc-846f-4213f9f64afd 52125-122 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20130314 ANDA ANDA078807 REMEDYREPACK INC. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 52125-123_a41567a3-4834-4d3a-b296-9e7055b76b3a 52125-123 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130314 ANDA ANDA074587 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52125-124_f1cdf2bb-57a4-490e-ae97-35fff031d0d5 52125-124 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20130314 ANDA ANDA075479 REMEDYREPACK INC. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 52125-125_7093e53d-42b1-4781-be85-3a30baf2509c 52125-125 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET ORAL 20130318 ANDA ANDA075037 REMEDYREPACK INC. ISOSORBIDE MONONITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 52125-126_75d01603-2714-48d2-9729-bcdf988665f6 52125-126 HUMAN PRESCRIPTION DRUG Procardia NIFEDIPINE CAPSULE ORAL 20130225 NDA NDA018482 REMEDYREPACK INC. NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-127_b4e4db9a-56f8-4fd4-b4b7-c8016f122152 52125-127 HUMAN PRESCRIPTION DRUG Actos pioglitazone TABLET ORAL 20130402 NDA NDA021073 REMEDYREPACK INC. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 52125-128_8bad6706-23c4-4a4f-84e2-4a5e900918df 52125-128 HUMAN PRESCRIPTION DRUG Allopurinol ALLOPURINOL TABLET ORAL 20120928 ANDA ANDA075798 REMEDYREPACK INC. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 52125-129_3b49a0c7-83bd-4350-96ed-acc53c9c70fb 52125-129 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20130226 ANDA ANDA090467 REMEDYREPACK INC. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-129_f7437da8-8d95-48d1-b182-d0fc3670f544 52125-129 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20141216 ANDA ANDA090467 REMEDYREPACK INC. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-130_21561324-7a3a-4263-af0d-23faabdaa1ec 52125-130 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20130401 NDA NDA021688 REMEDYREPACK INC. CINACALCET HYDROCHLORIDE 30 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] 52125-131_e1af3ff6-dbf1-49b0-99a7-108f0743182e 52125-131 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20120928 ANDA ANDA074984 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52125-132_09a1895a-8162-4c12-b5e8-c3ba19ee8b0f 52125-132 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride TRIHEXYPHENIDYL HYDROCHLORIDE TABLET ORAL 20121001 ANDA ANDA084364 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 52125-133_3682b0e1-c5db-49d7-ab75-262dd87b1518 52125-133 HUMAN PRESCRIPTION DRUG TAPAZOLE methimazole TABLET ORAL 20130313 ANDA ANDA040320 REMEDYREPACK INC. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 52125-134_817e6c06-4749-4f3d-b901-befa642f25c5 52125-134 HUMAN PRESCRIPTION DRUG Divalproex SodiumDelayed-Release Delayed-Release Divalproex Sodium TABLET, FILM COATED ORAL 20130225 ANDA ANDA090210 REMEDYREPACK INC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 52125-135_1a1683f1-eb9f-4c78-8d13-7a6d55212b1b 52125-135 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20121001 ANDA ANDA062676 REMEDYREPACK INC. DOXYCYCLINE HYCLATE 100 mg/1 52125-136_f31c7a3a-9af9-47d3-9097-3447c4fa6fd1 52125-136 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130326 ANDA ANDA075165 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 52125-138_1e462a94-bae6-4c10-9a9b-93ce8b4c9b62 52125-138 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20130313 ANDA ANDA084114 REMEDYREPACK INC. CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-139_01d47c8d-1deb-4772-baa9-ae63b15093db 52125-139 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20130313 ANDA ANDA040655 REMEDYREPACK INC. HYDROCODONE BITARTRATE 5 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 52125-140_1bb97291-1cf8-48c6-bb5d-63eeba57bfee 52125-140 HUMAN PRESCRIPTION DRUG Biaxin Clarithromycin TABLET, FILM COATED ORAL 20130313 NDA NDA050662 REMEDYREPACK INC. CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 52125-141_1c38ae48-2e1a-4822-87dc-3663a2a8e8cf 52125-141 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin TABLET, FILM COATED ORAL 20130327 ANDA ANDA076182 REMEDYREPACK INC. OFLOXACIN 200 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-143_1d5f2b99-4c80-4c14-aed5-5198d951a560 52125-143 HUMAN PRESCRIPTION DRUG TIGAN trimethobenzamide hydrochloride CAPSULE ORAL 20130520 NDA NDA017531 REMEDYREPACK INC. TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 52125-143_4f0b1d89-9951-44d7-b4e9-4810e88f5112 52125-143 HUMAN PRESCRIPTION DRUG TIGAN trimethobenzamide hydrochloride CAPSULE ORAL 20130311 NDA NDA017531 REMEDYREPACK INC. TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 52125-143_c7fc25f8-c00a-4b19-b009-eac6878be525 52125-143 HUMAN PRESCRIPTION DRUG TIGAN trimethobenzamide hydrochloride CAPSULE ORAL 20130312 NDA NDA017531 REMEDYREPACK INC. TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 52125-144_d00562b3-dc1d-40a2-8a5d-d590371fe5a0 52125-144 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130209 NDA NDA011856 REMEDYREPACK INC. METHYLPREDNISOLONE SODIUM SUCCINATE 1 g/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52125-146_02e5204d-d72d-46fb-9003-979e72eb0f0a 52125-146 HUMAN PRESCRIPTION DRUG Clotrimazole Clotrimazole LOZENGE ORAL 20130325 ANDA ANDA076387 REMEDYREPACK INC. CLOTRIMAZOLE 10 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 52125-147_d44387ad-bd68-4c56-8726-eb0893e7274e 52125-147 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20130611 ANDA ANDA077570 REMEDYREPACK INC. FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52125-147_edb97e11-90a7-4f2f-a98b-8b142a70ecd3 52125-147 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20131217 ANDA ANDA077570 REMEDYREPACK INC. FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52125-148_8ac29908-0090-415a-bbe5-f3e9108136b1 52125-148 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20130410 NDA NDA021402 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-149_6af84e50-1ab5-4fbe-8478-c6c9685ff719 52125-149 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130326 ANDA ANDA091269 REMEDYREPACK INC. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 52125-150_6ad672b8-94cc-42c1-b05a-7c2dcd259ac0 52125-150 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20121002 ANDA ANDA080292 REMEDYREPACK INC. PREDNISONE 5 mg/1 52125-151_b67d7850-146f-4ee9-823d-3274bfe395b1 52125-151 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20130227 NDA NDA021402 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-152_5939b246-1d7b-4a10-b023-a521c7f680d9 52125-152 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE TABLET ORAL 20121002 ANDA ANDA073568 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52125-154_af23a070-fc17-4393-a13c-50adc8fea4fa 52125-154 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130327 ANDA ANDA079132 REMEDYREPACK INC. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 52125-155_85966afb-72c2-4913-98cb-15cca6449453 52125-155 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130318 ANDA ANDA089883 REMEDYREPACK INC. HYDROCODONE BITARTRATE 5 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 52125-156_2c79c706-c3a5-4535-8a50-c7d7ac765801 52125-156 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20130319 NDA NDA016620 REMEDYREPACK INC. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 52125-156_410acdaa-74ac-41f1-8e4a-f310515c5314 52125-156 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20130403 NDA NDA016620 REMEDYREPACK INC. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 52125-156_42b80dc5-ed7b-4543-86dc-7251d900a5ff 52125-156 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20130403 NDA NDA016620 REMEDYREPACK INC. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 52125-156_7e862a0b-c525-44cc-8b99-f0b29a99b8ae 52125-156 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20130614 NDA NDA016620 REMEDYREPACK INC. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 52125-157_b90da028-d34a-4ca8-8e59-678891747e73 52125-157 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20130326 ANDA ANDA070719 REMEDYREPACK INC. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-158_1030ca7d-34ce-4539-b956-a92cea8c6197 52125-158 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130318 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-159_ffda8c85-3d76-4abc-8b33-f9ba0960545b 52125-159 HUMAN PRESCRIPTION DRUG Gris-PEG griseofulvin TABLET, FILM COATED ORAL 20130222 NDA NDA050475 REMEDYREPACK INC. GRISEOFULVIN 250 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 52125-160_d26fdd7e-eed0-4ada-90bf-6c6ee9258638 52125-160 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20130320 ANDA ANDA040684 REMEDYREPACK INC. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-161_a2964eb8-3ee1-40fa-8e6d-345823f09c68 52125-161 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20130725 ANDA ANDA078250 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-162_9f30a405-ab61-4667-9637-a44ad7f37535 52125-162 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20130325 ANDA ANDA084234 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-163_83736c9c-8c73-498c-ba3d-d2ab02b4f881 52125-163 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20130318 NDA NDA018569 REMEDYREPACK INC. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 52125-164_3d839841-88b1-4ae5-9849-b46873c78abd 52125-164 HUMAN PRESCRIPTION DRUG Enalapril Maleate ENALAPRIL MALEATE TABLET ORAL 20121003 ANDA ANDA075480 REMEDYREPACK INC. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 52125-165_dac04673-942b-464b-acef-3e30bea8318a 52125-165 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20130320 ANDA ANDA075994 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-166_d819bb63-44c8-465f-8ad4-32331c2d37cc 52125-166 HUMAN PRESCRIPTION DRUG Atenolol ATENOLOL TABLET ORAL 20121127 ANDA ANDA073025 REMEDYREPACK INC. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-167_106bb0f2-9803-48f3-900b-0affbd694976 52125-167 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20130318 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 52125-168_f9141b3f-d8c4-4647-a8ac-14ea17aa3b9c 52125-168 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20130318 ANDA ANDA077032 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-169_e83ed914-c779-4690-a5dd-803a7513a2ad 52125-169 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20130318 ANDA ANDA040103 REMEDYREPACK INC. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 52125-170_72e2991b-ec58-4493-8382-d33f45b242b8 52125-170 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 20130320 ANDA ANDA072709 REMEDYREPACK INC. MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 52125-171_c10b326e-1bb4-47a4-b14b-052605f9c7d6 52125-171 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20130318 ANDA ANDA070317 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 52125-172_caa5c29d-f109-4d03-8c17-a8362ddc342b 52125-172 HUMAN PRESCRIPTION DRUG INVEGA paliperidone TABLET, EXTENDED RELEASE ORAL 20130327 NDA NDA021999 REMEDYREPACK INC. PALIPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 52125-173_0654f2aa-49d2-467a-97f7-108c1eddfe51 52125-173 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20130318 ANDA ANDA077797 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 52125-174_7790bcf2-7247-4ca4-b935-ed38032cf186 52125-174 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate clopidogrel TABLET, FILM COATED ORAL 20130326 ANDA ANDA077665 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 52125-175_dd384f05-e70b-4b5c-b27a-18ee9eef97e1 52125-175 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20130325 ANDA ANDA080738 REMEDYREPACK INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 52125-176_57f37754-f042-47b2-a2f7-4f78686c2b78 52125-176 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium PHENYTOIN SODIUM CAPSULE ORAL 20121226 ANDA ANDA040765 REMEDYREPACK INC. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-177_e855d028-f78b-44c6-837d-0efeb246469f 52125-177 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20130325 ANDA ANDA074260 REMEDYREPACK INC. CARBIDOPA 25 mg/1 52125-178_9d2a6183-a073-4102-afa7-c7d70031a67a 52125-178 HUMAN PRESCRIPTION DRUG Losartan Potassium LOSARTAN POTASSIUM TABLET, FILM COATED ORAL 20121227 ANDA ANDA077424 REMEDYREPACK INC. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-179_d1e3c91e-91ff-4029-b907-b27cb2ef074c 52125-179 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20130325 ANDA ANDA077828 REMEDYREPACK INC. CARBIDOPA 25 mg/1 52125-180_0ab4d2d6-872b-4602-b5f9-a0ad9bb46695 52125-180 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET ORAL 20131007 ANDA ANDA078536 REMEDYREPACK INC. CARBIDOPA 10 mg/1 52125-180_eaf4492d-a242-4815-b23a-eacb51dfd109 52125-180 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET ORAL 20130328 ANDA ANDA078536 REMEDYREPACK INC. CARBIDOPA 10 mg/1 52125-181_fb4f7d75-7da8-46e1-915f-4b240bd1931a 52125-181 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20130327 ANDA ANDA090702 REMEDYREPACK INC. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 52125-182_0fc86512-98ca-4e34-95af-e9e3a395a9e2 52125-182 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 20130327 ANDA ANDA040195 REMEDYREPACK INC. ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 52125-183_bc680da3-65fc-4077-b096-5480f8e40007 52125-183 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate ISOSORBIDE DINITRATE TABLET ORAL 20121227 ANDA ANDA089367 REMEDYREPACK INC. ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 52125-184_d3ee39da-6d32-40db-a93a-db06f041b409 52125-184 HUMAN PRESCRIPTION DRUG Olanzapine OLANZAPINE TABLET, FILM COATED ORAL 20130104 ANDA ANDA076000 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 52125-185_510ac089-2a43-4868-b46e-2f8a49b36659 52125-185 HUMAN PRESCRIPTION DRUG Ziprasidone ZIPRASIDONE HYDROCHLORIDE CAPSULE ORAL 20130108 NDA AUTHORIZED GENERIC NDA020825 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE ANHYDROUS 80 mg/1 Atypical Antipsychotic [EPC] 52125-186_68826884-14c5-478f-a4de-865a3db7ec8d 52125-186 HUMAN PRESCRIPTION DRUG Ziprasidone ZIPRASIDONE HYDROCHLORIDE CAPSULE ORAL 20130104 NDA AUTHORIZED GENERIC NDA020825 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 52125-187_7a045f82-159e-4893-8afc-ac981bf5512c 52125-187 HUMAN PRESCRIPTION DRUG Ziprasidone ziprasidone hydrochloride CAPSULE ORAL 20130327 NDA AUTHORIZED GENERIC NDA020825 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 52125-188_b925c6f3-af2b-4515-ad04-d8a2fec3ea4b 52125-188 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20130403 NDA NDA009218 REMEDYREPACK INC. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-189_8518e256-96a8-4434-b7d5-20cef6e19f01 52125-189 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20130327 NDA NDA009218 REMEDYREPACK INC. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-190_323c6dc4-3908-408b-99f2-acb4c311b3c4 52125-190 HUMAN PRESCRIPTION DRUG Naproxen NAPROXEN TABLET ORAL 20121228 ANDA ANDA074201 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-192_fe6872f5-6fc4-44b2-b4b2-6ab51b9956e3 52125-192 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 20130603 ANDA ANDA040101 REMEDYREPACK INC. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-198_3ec458ca-2501-4776-b867-ae166ed09db0 52125-198 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20130326 ANDA ANDA070920 REMEDYREPACK INC. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 52125-199_6cadc5e6-7833-431b-90ce-e6e3625cd9cb 52125-199 HUMAN PRESCRIPTION DRUG GLIPIZIDE GLIPIZIDE TABLET ORAL 20130103 ANDA ANDA074497 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-200_11820149-680d-4f92-b5a9-072af120770c 52125-200 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20130328 ANDA ANDA201190 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 52125-201_1c3ba632-2428-4abe-9fcd-c9dec18df510 52125-201 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20130328 ANDA ANDA201190 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 52125-202_af6bcd08-4e7d-4721-b171-0a54e995913b 52125-202 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20130318 ANDA ANDA040756 REMEDYREPACK INC. FOLIC ACID 1 mg/1 52125-203_4d5c8026-f224-445d-83fa-325de7913178 52125-203 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130209 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-204_960d274e-41b4-45ff-b3ff-a32c870f3d72 52125-204 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20130209 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 52125-205_4d91c378-02ec-440a-bba9-c093039b13f3 52125-205 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130209 ANDA ANDA083177 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 52125-206_691bdcfe-8477-4a50-8306-39b598c6d82f 52125-206 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20130209 ANDA ANDA062396 REMEDYREPACK INC. DOXYCYCLINE HYCLATE 100 mg/1 52125-207_aa052bc6-6757-4b6d-9ac8-beafdbfe9a9a 52125-207 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20130209 ANDA ANDA078170 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-208_7b2d445e-19d2-4dd6-9934-37b2475f14cf 52125-208 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20130209 ANDA ANDA079139 REMEDYREPACK INC. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 52125-209_c22e1146-3467-4bf0-bb50-6a544e2a7c6b 52125-209 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20130320 ANDA ANDA078459 REMEDYREPACK INC. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-210_d99c4e77-deb9-4546-a8a7-e936584666c7 52125-210 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130318 ANDA ANDA076373 REMEDYREPACK INC. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-211_cd3d8581-b216-4e95-988f-8793421bf102 52125-211 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130328 ANDA ANDA078866 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 52125-212_86553de0-6517-40f3-a375-cbb7a2dbf94e 52125-212 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin Monohydrate TABLET, FILM COATED ORAL 20130919 ANDA ANDA065153 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-212_c68d1b10-c304-4e8f-955a-bdfb14f11bec 52125-212 HUMAN PRESCRIPTION DRUG Azithromycin AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED ORAL 20121228 ANDA ANDA065153 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-213_6e232ade-1c6d-47b1-b6e1-772cd2a28c4f 52125-213 HUMAN PRESCRIPTION DRUG Lisinopril LISINOPRIL TABLET ORAL 20121231 ANDA ANDA075752 REMEDYREPACK INC. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-214_3aecfa38-9fe3-423e-80bd-df5fda14da51 52125-214 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130329 ANDA ANDA074425 REMEDYREPACK INC. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 52125-215_2a7a9fd5-9833-4b5e-97a4-73ad13f32d13 52125-215 HUMAN PRESCRIPTION DRUG GLIPIZIDE GLIPIZIDE TABLET ORAL 20130102 ANDA ANDA074223 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-216_3f53778c-e053-4768-aed7-726b2be5bbc7 52125-216 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20130327 NDA AUTHORIZED GENERIC NDA020504 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 52125-217_c40f7702-f961-4067-b7be-043ce3633d4d 52125-217 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20130522 ANDA ANDA077397 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-217_cecd82c4-d951-4b7f-9e4d-36681c3b972b 52125-217 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20130327 ANDA ANDA077397 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-218_0709127f-01bc-44eb-bf4e-1bdb56a29059 52125-218 HUMAN PRESCRIPTION DRUG Loratadineantihistamine antihistamine Loratadine TABLET ORAL 20140206 ANDA ANDA076301 REMEDYREPACK INC. LORATADINE 10 mg/1 52125-220_02b13db1-95b0-4494-96c5-0bba556e9c16 52125-220 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 20130211 ANDA ANDA072741 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 52125-221_7562d0bc-b347-4812-9632-06f1e0136434 52125-221 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20130328 ANDA ANDA091038 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 52125-222_08e24c2a-daa2-46ca-a0b5-fd13582b2dc3 52125-222 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20130401 ANDA ANDA091038 REMEDYREPACK INC. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 52125-223_a1463f3e-37d7-4fd6-8f40-202ae0ac2697 52125-223 HUMAN PRESCRIPTION DRUG Diflucan fluconazole TABLET ORAL 20130219 NDA NDA019949 REMEDYREPACK INC. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 52125-224_ebed96ae-f5e2-44cc-98f0-d5edbae13665 52125-224 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20130211 ANDA ANDA075347 REMEDYREPACK INC. OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 52125-225_5121cd8a-3e99-46b7-b14c-dfc8462cc810 52125-225 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20130306 ANDA ANDA077995 REMEDYREPACK INC. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-225_d3259486-7804-4ddb-abc4-7b68dac7444c 52125-225 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20130306 ANDA ANDA077995 REMEDYREPACK INC. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-226_e8191e88-5038-47e8-904e-4fc1b07f72c2 52125-226 HUMAN PRESCRIPTION DRUG Sulfadiazine Sulfadiazine TABLET ORAL 20130211 ANDA ANDA040091 REMEDYREPACK INC. SULFADIAZINE 500 mg/1 Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 52125-227_32a90219-b5db-4116-8bda-0af80ef7ec98 52125-227 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20130219 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-229_c519535e-261c-4133-8606-88d42408a3fa 52125-229 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20130211 ANDA ANDA072234 REMEDYREPACK INC. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 52125-230_fb916230-8476-4937-907a-8cc494f885b0 52125-230 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130308 ANDA ANDA090615 REMEDYREPACK INC. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-231_a3b3d0ac-4f43-404a-82e6-b9b63cd42d89 52125-231 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine TABLET ORAL 20130211 ANDA ANDA077533 REMEDYREPACK INC. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 52125-232_3fd73bf1-3f2c-453a-ac38-2c8f0b6d521c 52125-232 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION/ DROPS OPHTHALMIC 20130926 ANDA ANDA064096 REMEDYREPACK INC. TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 52125-232_be039eae-301b-4180-be48-fe6c0053ba21 52125-232 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION/ DROPS OPHTHALMIC 20130613 ANDA ANDA064096 REMEDYREPACK INC. TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 52125-234_0714cd18-5658-48bd-9a5f-6fa5b6bd5218 52125-234 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20130501 ANDA ANDA078558 REMEDYREPACK INC. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-234_42efb137-ab85-4357-a2dd-3386b083448f 52125-234 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20130211 ANDA ANDA078558 REMEDYREPACK INC. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-234_a81c699f-0ec2-4ab3-a8ff-109b7360d1a2 52125-234 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20130211 ANDA ANDA078558 REMEDYREPACK INC. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-235_7a65e9b2-d480-4250-bf30-ca23694d001f 52125-235 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 20130306 ANDA ANDA072637 REMEDYREPACK INC. ALBUTEROL SULFATE 2 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 52125-236_02c40495-b70a-4aae-b636-d2d36256f575 52125-236 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20130613 ANDA ANDA088042 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 1 mg/g 52125-236_a870c9fc-49b4-403c-b949-432e6adaaa00 52125-236 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20131203 ANDA ANDA088042 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 1 mg/g 52125-239_159dab5c-9d5a-4c6e-827e-a84663c0c58d 52125-239 HUMAN PRESCRIPTION DRUG mupirocin Mupirocin OINTMENT TOPICAL 20131122 ANDA ANDA065123 REMEDYREPACK INC. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 52125-239_87a4ee73-0544-41d5-9e25-54c66a5c9c89 52125-239 HUMAN PRESCRIPTION DRUG mupirocin Mupirocin OINTMENT TOPICAL 20130612 ANDA ANDA065123 REMEDYREPACK INC. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 52125-243_8d12f500-e906-45b0-b89d-a4965eeeb4bc 52125-243 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20130506 ANDA ANDA090540 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 52125-243_fea9e2b3-d9d0-4cff-a910-d6636084bf45 52125-243 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20130506 ANDA ANDA090540 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 52125-244_effa9f6f-f04e-4635-868d-2a0fb7a4b381 52125-244 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20130219 ANDA ANDA077580 REMEDYREPACK INC. HALOPERIDOL 20 mg/1 Typical Antipsychotic [EPC] 52125-245_6a9903a2-957e-4b31-adda-ad879a61b62a 52125-245 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20130502 ANDA ANDA075593 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-245_70169dfa-aa2e-40b5-b2ae-d7ad18335eb0 52125-245 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20130502 ANDA ANDA075593 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-245_bced7378-4915-4b15-9721-ae7d96040e5f 52125-245 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20130716 ANDA ANDA075593 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-245_d165dc9e-3169-4d75-9b30-081ffcb2718d 52125-245 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20130502 ANDA ANDA075593 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-246_1fae60f0-ba35-4481-b7f5-bf35f1075503 52125-246 HUMAN PRESCRIPTION DRUG Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20130710 ANDA ANDA040466 REMEDYREPACK INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 52125-246_2f15d46a-ad15-453f-9f71-460f264c6de1 52125-246 HUMAN PRESCRIPTION DRUG Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20130613 ANDA ANDA040466 REMEDYREPACK INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 52125-246_b1b9d5e8-45d6-443f-b942-0a66098332d0 52125-246 HUMAN PRESCRIPTION DRUG Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20131118 ANDA ANDA040466 REMEDYREPACK INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 52125-248_a5464347-d379-4607-9b30-e04eebe56c2b 52125-248 HUMAN PRESCRIPTION DRUG Atropine Sulfate ATROPINE SULFATE INJECTION, SOLUTION INTRAMUSCULAR 20131031 NDA NDA021146 REMEDYREPACK INC. ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52125-249_a0480d70-6e24-41fe-91f3-c96ad66e9442 52125-249 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 20131121 NDA NDA016694 REMEDYREPACK INC. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 52125-249_a52cc7f6-2d34-4f69-b086-355ce2cb8d84 52125-249 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 20130612 NDA NDA016694 REMEDYREPACK INC. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 52125-250_71032352-bdeb-443d-a4bb-c666125fdf4f 52125-250 HUMAN PRESCRIPTION DRUG Naproxen naproxen TABLET ORAL 20130604 ANDA ANDA091416 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-251_5e30393d-ce3d-4333-99d4-cc8bb7cfecff 52125-251 HUMAN PRESCRIPTION DRUG Ziprasidone ziprasidone hydrochloride CAPSULE ORAL 20130502 NDA AUTHORIZED GENERIC NDA020825 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 52125-252_b0bf4519-0a6d-4f0b-9aeb-7a92162db267 52125-252 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130617 ANDA ANDA090615 REMEDYREPACK INC. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-253_59fc67df-33bd-43b5-8b0c-e092c327c2e9 52125-253 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20130603 NDA NDA021724 REMEDYREPACK INC. PREGABALIN 150 mg/1 52125-254_a64465ed-bc2c-4454-a15d-0aa2d2654b40 52125-254 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20130502 ANDA ANDA078777 REMEDYREPACK INC. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-255_02062d42-24a6-4cd6-a8e0-a475afc34323 52125-255 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130617 ANDA ANDA040256 REMEDYREPACK INC. PREDNISONE 10 mg/1 52125-256_0f4191ec-d429-4b59-8bdc-0cfdbfbce19b 52125-256 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20130502 ANDA ANDA087836 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 52125-257_18fc4ed4-5665-4a23-9c17-1c0c0078e917 52125-257 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20130604 ANDA ANDA075133 REMEDYREPACK INC. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-258_8b9008df-5960-4e69-b3b5-2f55298a8792 52125-258 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20130919 ANDA ANDA076710 REMEDYREPACK INC. LEVOFLOXACIN 500 mg/1 52125-258_d426b771-8bf0-41f0-9c17-43b11edfa2f7 52125-258 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131211 ANDA ANDA076710 REMEDYREPACK INC. LEVOFLOXACIN 500 mg/1 52125-258_f910f621-a3c6-4cff-86f7-766bb1bba86c 52125-258 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20130919 ANDA ANDA076710 REMEDYREPACK INC. LEVOFLOXACIN 500 mg/1 52125-259_1ba766eb-5d6a-4b8f-9d5e-27429119c5ac 52125-259 HUMAN PRESCRIPTION DRUG Colcrys Colchicine TABLET, FILM COATED ORAL 20130503 NDA NDA022352 REMEDYREPACK INC. COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 52125-260_673d46ff-c134-42cd-8d64-f05c6113752c 52125-260 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20130503 ANDA ANDA075022 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 5 mg/1 52125-261_fd284ce9-3be4-4d5b-b740-d66f40f5edca 52125-261 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20130502 ANDA ANDA075022 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 10 mg/1 52125-262_1a9c378b-1cca-409c-a39c-3ffcea07fb22 52125-262 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20130530 ANDA ANDA090598 REMEDYREPACK INC. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 52125-262_f4e932fa-8e7f-4b26-b8ed-d9d8e7062779 52125-262 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20130821 ANDA ANDA090598 REMEDYREPACK INC. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 52125-263_9c55446e-2dcd-4dd3-ae8d-e072b84820d3 52125-263 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20131211 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-264_5131eaff-8b47-4061-83e6-d2df27163637 52125-264 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 20130604 ANDA ANDA062364 REMEDYREPACK INC. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 52125-265_52821a9f-545c-4877-b05c-3f7c76e1cad9 52125-265 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20131122 ANDA ANDA077401 REMEDYREPACK INC. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 52125-265_7373b886-e647-4eeb-bd08-b781c1ba2e4e 52125-265 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20130617 ANDA ANDA077401 REMEDYREPACK INC. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 52125-266_4c582500-77fa-455e-966c-220c6ed4361e 52125-266 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20130503 ANDA ANDA079098 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-267_03b51500-25f3-4c33-a071-5206f5ba490e 52125-267 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20130506 ANDA ANDA065404 REMEDYREPACK INC. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-267_8dc0818b-cbd3-4055-8c78-9a501b640843 52125-267 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20130524 ANDA ANDA065404 REMEDYREPACK INC. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-268_16f7b447-0978-4b2c-9379-dd90db694924 52125-268 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20130506 ANDA ANDA077557 REMEDYREPACK INC. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-268_70a5e49e-9b7f-44c9-8c32-98b9cbdb3fd0 52125-268 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20130610 ANDA ANDA077557 REMEDYREPACK INC. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-269_c059c89f-83b4-4ccb-b17a-7f576e824760 52125-269 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130705 ANDA ANDA075752 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-271_0134c149-e72c-4b60-9dda-eec4b06dd99b 52125-271 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate and hydrocortisone SUSPENSION AURICULAR (OTIC) 20131122 ANDA ANDA062488 REMEDYREPACK INC. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 52125-271_613cf670-9c9e-468f-b1dc-a16dbcacf8e9 52125-271 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate and hydrocortisone SUSPENSION AURICULAR (OTIC) 20130613 ANDA ANDA062488 REMEDYREPACK INC. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 52125-274_5ebc6bad-3ac1-46ea-b012-b825aea76d7c 52125-274 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine TABLET ORAL 20130530 ANDA ANDA089175 REMEDYREPACK INC. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 52125-275_fd2480ae-23af-43bd-a4d9-0ca7631fc7e7 52125-275 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20130506 ANDA ANDA040511 REMEDYREPACK INC. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 52125-276_9f35af32-2441-48f6-a820-dea8b5841969 52125-276 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 20131220 ANDA ANDA089718 REMEDYREPACK INC. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 52125-277_f6a141ae-8a24-4e9a-b1ce-c012bd733379 52125-277 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20130604 ANDA ANDA090404 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 52125-278_c5d1efcf-2ee9-4f0e-8e5a-b5996ba19caa 52125-278 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20130507 ANDA ANDA076670 REMEDYREPACK INC. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-279_184ed09e-3fe2-45ad-a2e8-ce85a55266cb 52125-279 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20130507 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-279_6277e66e-e232-4f96-a503-3c96aceb174c 52125-279 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140611 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-279_8b62ce1a-0010-4590-9095-ece485008ce4 52125-279 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140611 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-279_dd670e9e-c92c-4ee3-a05b-f4161419cb1d 52125-279 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140228 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-279_f77abc5e-6878-4dd9-9f1c-77b37132d0f8 52125-279 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20130507 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-280_a5fbfc1f-400a-45d5-b07e-700d5844aa22 52125-280 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130507 ANDA ANDA079132 REMEDYREPACK INC. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 52125-281_279b99e7-d1ec-4418-83c4-38e8029c787c 52125-281 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 20130507 ANDA ANDA072637 REMEDYREPACK INC. ALBUTEROL SULFATE 2 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 52125-282_0e298eb5-5fc6-4556-aca4-b0fe0d33dd15 52125-282 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET ORAL 20130507 ANDA ANDA018558 REMEDYREPACK INC. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 52125-283_061d48b6-fc5e-479a-8298-f261cca95723 52125-283 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION OPHTHALMIC 20131125 ANDA ANDA076231 REMEDYREPACK INC. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-283_13bb8e44-6daa-43ca-b277-922db0d3ceb9 52125-283 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION OPHTHALMIC 20130613 ANDA ANDA076231 REMEDYREPACK INC. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-284_363c0516-2550-4532-aaac-bd90f8cd44fc 52125-284 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20130506 ANDA ANDA084112 REMEDYREPACK INC. CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-285_15e4f23d-84c7-438a-b53e-9149e63d0f36 52125-285 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 20130506 NDA NDA020272 REMEDYREPACK INC. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 52125-286_10549578-a365-4445-ba4c-c69eb1590ba9 52125-286 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20130506 ANDA ANDA077670 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-289_0de3cfcc-7f09-433b-93e5-2f0f4f68a868 52125-289 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20130506 ANDA ANDA077032 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-290_4be99ef5-9cbe-4ca3-b8e9-96b7a04d1063 52125-290 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 20130506 NDA NDA020272 REMEDYREPACK INC. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 52125-291_7e36e1e2-5630-4505-9f22-2163b0640806 52125-291 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130508 ANDA ANDA077321 REMEDYREPACK INC. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-292_acf4e08f-88c8-4585-ba0d-85616ec29588 52125-292 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20130507 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-292_b23abe64-b88d-4bcc-a25a-cab8c22c8e6a 52125-292 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20130506 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-294_21140a7f-61f1-498e-8a1a-039072b64378 52125-294 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 20130507 NDA NDA020272 REMEDYREPACK INC. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 52125-295_84a7007b-23bd-4dba-8ea9-99608a34a5a8 52125-295 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130507 ANDA ANDA040148 REMEDYREPACK INC. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 52125-296_d100a85d-e8e4-46c0-9528-23b8df54d7e4 52125-296 HUMAN PRESCRIPTION DRUG Gentak Gentamicin Sulfate OINTMENT OPHTHALMIC 20130624 ANDA ANDA064093 REMEDYREPACK INC. GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 52125-297_1d9b6e67-0639-435d-a48a-8e07ff33e936 52125-297 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20130604 ANDA ANDA075185 REMEDYREPACK INC. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-298_918472ba-58ed-4706-bf7e-6de715e76a08 52125-298 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED ORAL 20130507 ANDA ANDA075977 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 52125-299_9c26e9ee-2dc4-4f16-8d46-30f9ab31d3bc 52125-299 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130507 ANDA ANDA076704 REMEDYREPACK INC. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-300_abc7e8a7-8552-43b1-97a2-acafee492bef 52125-300 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE ORAL 20130508 ANDA ANDA040765 REMEDYREPACK INC. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-301_50fb6763-5080-4f6f-8a37-44d0fa2ecd82 52125-301 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20130508 ANDA ANDA073457 REMEDYREPACK INC. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-302_ff71220b-fd09-4a60-84af-a7a514fb8431 52125-302 HUMAN PRESCRIPTION DRUG mirtazapine mirtazapine TABLET, FILM COATED ORAL 20130508 ANDA ANDA076219 REMEDYREPACK INC. MIRTAZAPINE 15 mg/1 52125-303_d321ffde-791b-40b1-b68c-11d9887b89e8 52125-303 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20130508 ANDA ANDA077534 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-304_e3327b35-cba1-4a09-9cad-430c0ab77011 52125-304 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20130508 ANDA ANDA090702 REMEDYREPACK INC. LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] 52125-305_1da9fa36-0b51-4a9b-b343-213cfaa5b5b8 52125-305 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130508 ANDA ANDA075752 REMEDYREPACK INC. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-306_12cf2450-a7f2-4fd0-b78c-1ea6613a077a 52125-306 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20130612 ANDA ANDA089682 REMEDYREPACK INC. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52125-306_d6accd00-9aff-4b64-b132-3a05ab2dd15c 52125-306 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20131121 ANDA ANDA089682 REMEDYREPACK INC. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52125-307_be1be05e-2351-4578-89ec-875cc0d1852d 52125-307 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 20130513 NDA NDA021087 REMEDYREPACK INC. OSELTAMIVIR PHOSPHATE 75 mg/1 Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] 52125-308_43cac939-968a-4ae4-8cdd-004db81307d1 52125-308 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20130513 ANDA ANDA084234 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-309_9edb7645-bd75-4d24-9a78-c882c3185847 52125-309 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20130513 ANDA ANDA018659 REMEDYREPACK INC. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 52125-310_9f998a4a-7fef-4ef0-a456-09a387c22a39 52125-310 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130513 NDA AUTHORIZED GENERIC NDA019839 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-311_a59a01e9-d0a3-4341-9063-39b2f16ddc75 52125-311 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130513 ANDA ANDA076373 REMEDYREPACK INC. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-312_aa780cfa-27b3-4bb5-84d8-dfa1a3e9f94a 52125-312 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20130513 ANDA ANDA078406 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-313_61195e89-52f2-470c-ac80-0685fd39393e 52125-313 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20130513 ANDA ANDA078406 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-314_e174ce67-249d-4a1b-bfb4-cd481deb6b62 52125-314 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20130513 ANDA ANDA040144 REMEDYREPACK INC. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 52125-316_0d25ee2d-bf96-444c-856b-54ed20f5739c 52125-316 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20130513 ANDA ANDA072926 REMEDYREPACK INC. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 52125-317_4df231b9-267b-495e-a1ac-57ce3b2a7247 52125-317 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20130508 NDA NDA021692 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 52125-317_564fd0f2-a993-48a7-8104-36115bebb627 52125-317 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20131031 NDA NDA021692 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 52125-320_f07082a7-31cd-4754-8bec-5095b10ffd9c 52125-320 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20130604 ANDA ANDA040812 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 52125-321_93f42950-093b-418b-9186-86409909dfb0 52125-321 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130508 ANDA ANDA075752 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-322_78f67f55-7813-4f90-98f4-588a6dba59d6 52125-322 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20130508 NDA AUTHORIZED GENERIC NDA020699 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-324_1bf06616-c96c-4737-bb32-a389d62b16ff 52125-324 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20130508 ANDA ANDA078777 REMEDYREPACK INC. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-325_82125300-a551-4f65-bebc-06169ccee578 52125-325 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20130513 ANDA ANDA018851 REMEDYREPACK INC. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-326_493a579d-7877-4ba9-9e49-6473138e52f2 52125-326 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20130508 ANDA ANDA076288 REMEDYREPACK INC. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 52125-327_1b6ba7df-b4e8-47b6-9571-29798c8a8f00 52125-327 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20130705 ANDA ANDA076187 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-328_6d91a83e-b4f3-4622-b1f6-f36764b8473f 52125-328 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20130508 ANDA ANDA075948 REMEDYREPACK INC. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 52125-329_0581d093-17bb-418a-8eda-4e35f33d505c 52125-329 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20130508 ANDA ANDA072928 REMEDYREPACK INC. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 52125-330_cf607605-2d13-47b1-98c4-3bdab21067d3 52125-330 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20130508 ANDA ANDA040103 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 52125-331_ef546eee-1a07-42ce-9446-057505f4f412 52125-331 HUMAN PRESCRIPTION DRUG Clarithromycin clarithromycin TABLET, FILM COATED ORAL 20130509 ANDA ANDA065195 REMEDYREPACK INC. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 52125-331_f7cf942d-14c0-4748-aae1-48a80782346e 52125-331 HUMAN PRESCRIPTION DRUG Clarithromycin clarithromycin TABLET, FILM COATED ORAL 20130513 ANDA ANDA065195 REMEDYREPACK INC. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 52125-332_12257322-3fce-41ed-9d5c-d35bcbf85465 52125-332 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20130610 ANDA ANDA077829 REMEDYREPACK INC. CETIRIZINE HYDROCHLORIDE 10 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 52125-332_1c47d410-757d-46aa-b513-de77c6d00dfb 52125-332 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20130604 ANDA ANDA077829 REMEDYREPACK INC. CETIRIZINE HYDROCHLORIDE 10 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 52125-332_5bbb8b50-da55-46bd-bed3-94a13844be3b 52125-332 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20130603 ANDA ANDA077829 REMEDYREPACK INC. CETIRIZINE HYDROCHLORIDE 10 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 52125-334_12359800-7f3b-4f53-92eb-d8da54ac27d4 52125-334 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR 20131125 ANDA ANDA077548 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-334_5005a04c-0878-4e75-b08c-b5879670bbcc 52125-334 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR 20130927 ANDA ANDA077548 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-334_825f6ca0-b3b6-480d-9f0d-c0b9e3dffd56 52125-334 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR 20130614 ANDA ANDA077548 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-334_a6425c41-d0cd-4c24-b902-34e7fdb70fd0 52125-334 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR 20131125 ANDA ANDA077548 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-335_97c3ce99-fc72-40bb-b90b-822452ebd159 52125-335 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION PARENTERAL 20130612 ANDA ANDA072076 REMEDYREPACK INC. NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 52125-336_aee74415-3165-4519-9152-ebe3ed919e32 52125-336 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20130509 ANDA ANDA075480 REMEDYREPACK INC. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 52125-337_4eb811fe-e073-450c-9441-5656c5aa02f0 52125-337 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130509 ANDA ANDA075165 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 52125-338_6085a66d-f4d1-4ebf-8aec-e61dc8bb8761 52125-338 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20130509 ANDA ANDA090035 REMEDYREPACK INC. FOLIC ACID 1 mg/1 52125-339_814f7992-aa93-4b4d-9e68-64d58fb91c53 52125-339 HUMAN PRESCRIPTION DRUG SSD Cream Silver Sulfadiazine CREAM TOPICAL 20131202 NDA NDA018578 REMEDYREPACK INC. SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 52125-339_d27826ee-4fab-47c1-ae04-4ae3cac4d62f 52125-339 HUMAN PRESCRIPTION DRUG SSD Cream Silver Sulfadiazine CREAM TOPICAL 20130613 NDA NDA018578 REMEDYREPACK INC. SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 52125-340_7ff5a72f-2a6b-46af-b2ef-846f33ab9c76 52125-340 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20130509 ANDA ANDA076001 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-341_a232c492-7aa1-423d-a44a-442f45437fc1 52125-341 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20130509 ANDA ANDA075985 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-342_35602c96-3419-4dd1-ae7d-4f98c5c00907 52125-342 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20130603 ANDA ANDA075465 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-343_23b4a8c2-3275-4a90-82b6-2a39e8878bcf 52125-343 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20130609 ANDA ANDA077797 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 52125-345_4802af58-bcf8-4d92-9cbf-b75676fbb443 52125-345 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130708 ANDA ANDA078251 REMEDYREPACK INC. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-346_9a677bc4-b9ad-4b48-abb1-e57c0d871282 52125-346 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 20130609 ANDA ANDA070925 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 52125-347_68f8d547-f6c5-431c-9305-f1cb3dad320f 52125-347 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET ORAL 20130604 ANDA ANDA077851 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-348_ad0ad0ac-0d7b-4075-9ce8-efad87ac5d3c 52125-348 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20130603 ANDA ANDA078243 REMEDYREPACK INC. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-349_85bf52f7-4143-4554-b7b5-a3d0b724cc9a 52125-349 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20130603 ANDA ANDA040901 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 52125-350_18d35729-9ae9-4226-ac4b-e342efc8a2ab 52125-350 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20130528 ANDA ANDA040901 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 52125-351_b36a3b60-434f-455a-889d-15965794cfee 52125-351 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130524 ANDA ANDA077752 REMEDYREPACK INC. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52125-352_8b9adeff-c9d3-44b6-b90a-2c9789924213 52125-352 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130528 NDA AUTHORIZED GENERIC NDA018279 REMEDYREPACK INC. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 52125-353_c0e51108-6b19-4022-b8e0-a7e8fb9d2f77 52125-353 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20130528 ANDA ANDA073457 REMEDYREPACK INC. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-354_7bc466d4-b4bd-4a94-8a6e-2be4d24cf49a 52125-354 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20130528 ANDA ANDA078170 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-355_9706ef2c-7a20-45fa-8e3e-db6088a84d7f 52125-355 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130705 ANDA ANDA078225 REMEDYREPACK INC. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-356_6a8a7815-0eaa-4b1e-b58e-22775326061d 52125-356 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20130528 ANDA ANDA088619 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 52125-357_5ee412b9-73f8-4a84-b35b-cc337c3a69d4 52125-357 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20130524 ANDA ANDA065095 REMEDYREPACK INC. DOXYCYCLINE HYCLATE 100 mg/1 52125-357_855d8be2-3963-4a7c-8b4d-71162dadf0dc 52125-357 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20130510 ANDA ANDA065095 REMEDYREPACK INC. DOXYCYCLINE HYCLATE 100 mg/1 52125-358_a3b62b1f-79c1-4441-8c52-95a8e91b6259 52125-358 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20130510 ANDA ANDA091630 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 52125-360_8b5146ee-a721-4ae0-969b-6b7f1c1b1e24 52125-360 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20130604 ANDA ANDA077584 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-361_8d23535a-fd3b-4238-8469-5825da94b0ab 52125-361 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20130513 ANDA ANDA091388 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 52125-362_d48de86f-d9ff-493a-818e-ba31cb831790 52125-362 HUMAN PRESCRIPTION DRUG Terazosin hydrochloride Terazosin hydrochloride CAPSULE ORAL 20130513 ANDA ANDA075614 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-363_33bdd6c6-723f-431a-b5d7-ab9b224116b7 52125-363 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20130513 ANDA ANDA078406 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-364_5fcf0f73-78a0-4afa-aa5c-5e05a45de7a1 52125-364 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20130701 ANDA ANDA088468 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 52125-365_38610d8a-05bd-4718-9fa6-12eeaf92f327 52125-365 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20130513 ANDA ANDA090527 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 52125-366_2b3a4eed-6c68-4751-9c16-20d49e86d497 52125-366 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130705 ANDA ANDA040256 REMEDYREPACK INC. PREDNISONE 5 mg/1 52125-370_540643ea-cbd9-4bd7-8bc7-b23d78ae206b 52125-370 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20131211 ANDA ANDA078251 REMEDYREPACK INC. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-371_03f84a40-75ef-48af-92f0-6d4e8f301027 52125-371 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20130513 ANDA ANDA077995 REMEDYREPACK INC. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-371_cd67844d-2b58-4e33-a5b4-5e40f165aa8e 52125-371 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20130513 ANDA ANDA077995 REMEDYREPACK INC. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-373_3696d082-ed96-4097-884d-743486b9b6f8 52125-373 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20130513 ANDA ANDA078558 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-373_9e52b5e6-74d2-4bf2-b2f0-2995e8f05f44 52125-373 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20130513 ANDA ANDA078558 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-374_d70d9903-702b-4492-a9ff-6aaa15226145 52125-374 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20130513 NDA NDA021134 REMEDYREPACK INC. NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 52125-375_314da7ec-8c63-4bc5-bc51-41ffc2a4ed1c 52125-375 HUMAN PRESCRIPTION DRUG ketoconazole ketoconazole CREAM TOPICAL 20140204 ANDA ANDA076294 REMEDYREPACK INC. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 52125-375_64d0c1af-61b1-4d88-81ff-4a7d63ea8fbd 52125-375 HUMAN PRESCRIPTION DRUG ketoconazole ketoconazole CREAM TOPICAL 20130612 ANDA ANDA076294 REMEDYREPACK INC. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 52125-376_5bcf0671-a92d-4003-b563-8e882040a089 52125-376 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20130513 ANDA ANDA078477 REMEDYREPACK INC. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-377_72f134a8-cb75-4a90-b599-9db780a413f5 52125-377 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20130513 ANDA ANDA076003 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 52125-378_413e2937-1003-4560-a42a-3c0d92af9924 52125-378 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20131031 ANDA ANDA074880 REMEDYREPACK INC. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 52125-378_7ce8d930-aeac-4e0e-8bfa-c224075f97b1 52125-378 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20130610 ANDA ANDA074880 REMEDYREPACK INC. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 52125-379_2474c0ab-576e-473b-8aa9-716d9b615e15 52125-379 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131105 ANDA ANDA078402 REMEDYREPACK INC. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-379_78f170dc-aff7-4cc8-ad21-e40bbb4e7604 52125-379 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130513 ANDA ANDA078402 REMEDYREPACK INC. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-380_3ff84786-0fcd-43ce-9aed-28d57b11e901 52125-380 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130513 ANDA ANDA040807 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 52125-380_dc6cddd8-b2bd-4b60-8602-be51c36b37cb 52125-380 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130513 ANDA ANDA040807 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 52125-381_a3d909ad-d5ff-4dda-a16c-5f41739cfb96 52125-381 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20130513 ANDA ANDA075536 REMEDYREPACK INC. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-382_1b78e093-d0e0-427d-a4fc-38935a3b4f6d 52125-382 HUMAN PRESCRIPTION DRUG ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET ORAL 20130513 ANDA ANDA090258 REMEDYREPACK INC. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 52125-383_61dad909-c5e5-42be-a250-dafb66df5433 52125-383 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20131118 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-383_6a53413d-d707-43f3-a68c-df484c5b890c 52125-383 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130827 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-384_0d436554-1714-4232-a2df-7de242b7c0e5 52125-384 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20140228 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-384_19ce66e2-141b-4203-b3c3-9ec606c1dcae 52125-384 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130513 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-384_39242b75-f8c3-4a58-9666-4a92c92f563b 52125-384 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130515 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-385_58434fcc-3d49-42f9-b4d1-bdc694db8839 52125-385 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20130513 ANDA ANDA040301 REMEDYREPACK INC. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-386_5fd37640-5f0d-4d4a-974a-d58a17d70b52 52125-386 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20130514 NDA NDA009218 REMEDYREPACK INC. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-387_d691be3c-56ae-498e-95ad-87a138ce2957 52125-387 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20130514 NDA NDA009218 REMEDYREPACK INC. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-388_5091317f-3bea-4ea8-ab91-6bba299c2851 52125-388 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20131112 ANDA ANDA077091 REMEDYREPACK INC. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-388_b73c862b-6e71-4f3c-b1a6-49a5c3bcfdf6 52125-388 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20130515 ANDA ANDA077091 REMEDYREPACK INC. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-389_4610b1e2-7dd1-4f09-811e-bf2936b5a3c4 52125-389 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20130514 ANDA ANDA077091 REMEDYREPACK INC. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-390_ae617e05-c6e9-41f6-87b9-99b90e42429d 52125-390 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20140714 ANDA ANDA076286 REMEDYREPACK INC. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 52125-390_fce2744d-e84e-4fe9-802d-90df1b6acbfd 52125-390 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20130219 ANDA ANDA076286 REMEDYREPACK INC. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 52125-391_867430b1-965e-44cc-bf94-11b865c7106c 52125-391 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 20130514 ANDA ANDA084285 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52125-392_15fd6823-2700-4343-b998-33728d102014 52125-392 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20130514 ANDA ANDA076345 REMEDYREPACK INC. GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-393_76fed0e3-a3f6-4944-ae70-07317b8a7608 52125-393 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20130514 ANDA ANDA076345 REMEDYREPACK INC. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-394_d0e1fe60-f8c4-45df-8360-722a346a4e68 52125-394 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20131118 ANDA ANDA090637 REMEDYREPACK INC. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 52125-394_fff9c567-b064-41d7-a981-b8e52e486834 52125-394 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20130514 ANDA ANDA090637 REMEDYREPACK INC. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 52125-395_6bc37e9d-e96d-46d8-866b-a1900eefc6c3 52125-395 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20130611 ANDA ANDA077538 REMEDYREPACK INC. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52125-396_df078a12-a92a-4c22-9976-6be9a65f62f9 52125-396 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130514 ANDA ANDA077127 REMEDYREPACK INC. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-397_fbf08372-0a5b-45ae-a453-1002a87b7e9b 52125-397 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20130209 ANDA ANDA090528 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 52125-398_680b495b-bed5-4946-878e-aab84abb1706 52125-398 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130514 ANDA ANDA077410 REMEDYREPACK INC. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-399_b636e7a3-3a21-4baf-b94e-07ea5bd70aa2 52125-399 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20130514 ANDA ANDA090528 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-399_b7f3463f-35e9-45af-aab4-7bb92ba47d52 52125-399 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20130514 ANDA ANDA090528 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-400_17e1733e-bd44-4773-8da7-7862b34c5810 52125-400 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140416 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-400_51389eb7-29f4-4925-9592-95f4205f2290 52125-400 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20131112 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-400_6d829659-733c-49ae-84f0-14155d5e9605 52125-400 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20130514 ANDA ANDA077095 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-401_5866d039-327e-4edb-ab4c-49b2603667c3 52125-401 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140220 ANDA ANDA078906 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52125-401_ed25edd3-a249-4492-8450-8f3bd9684d7c 52125-401 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130514 ANDA ANDA078906 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52125-403_77a4bfc6-8a83-4cb1-9983-4595b11aeac2 52125-403 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET ORAL 20130514 ANDA ANDA076437 REMEDYREPACK INC. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 52125-404_5cafb7d8-778d-480e-8ce1-f7ece0e695e0 52125-404 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20130617 ANDA ANDA077912 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-404_95695891-9a20-4b0c-9155-dce35fdda475 52125-404 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20140616 ANDA ANDA077912 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-404_cf300bea-344e-4343-a0df-0e1741f527eb 52125-404 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20130617 ANDA ANDA077912 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-405_711bbd43-6b32-40f4-ae23-3cafd3e28b40 52125-405 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130514 ANDA ANDA075991 REMEDYREPACK INC. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52125-405_dd769be6-9ff3-411d-8a11-0f0837a7ad51 52125-405 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20131105 ANDA ANDA075991 REMEDYREPACK INC. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52125-406_a3af07e0-9353-455b-a963-a8ee59c2b94a 52125-406 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130514 ANDA ANDA076063 REMEDYREPACK INC. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-407_f5857616-08a9-46ff-8a4b-3994947de2aa 52125-407 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20130514 ANDA ANDA090467 REMEDYREPACK INC. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-408_64af552d-4d67-452e-b75f-4d7241583cb9 52125-408 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20130515 ANDA ANDA076286 REMEDYREPACK INC. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 52125-411_b0d5a323-9b29-4e8c-a57b-5740a514621a 52125-411 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20130515 ANDA ANDA085828 REMEDYREPACK INC. SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 52125-412_1072d249-c819-44ec-9609-1a6fba54d9b0 52125-412 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130515 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-412_f7be1056-be63-402d-b2cd-f17e96e16231 52125-412 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130515 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-413_0e064b7c-debe-4149-bf10-fba52a694250 52125-413 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC) 20130613 ANDA ANDA076128 REMEDYREPACK INC. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-413_27f89216-35df-4b46-8303-f2661db7220a 52125-413 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC) 20131125 ANDA ANDA076128 REMEDYREPACK INC. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-414_4c714861-6964-4ecf-bf7e-2f353c9226c2 52125-414 HUMAN PRESCRIPTION DRUG Novolin70/30 70/30 Human Insulin INJECTION, SUSPENSION SUBCUTANEOUS 20140729 NDA NDA019991 REMEDYREPACK INC. INSULIN HUMAN 100 [USP'U]/mL Insulin [Chemical/Ingredient],Insulin [EPC] 52125-414_ea917f6b-3e25-4236-93ae-9376d5282b27 52125-414 HUMAN PRESCRIPTION DRUG Novolin70/30 70/30 Human Insulin INJECTION, SUSPENSION SUBCUTANEOUS 20130613 NDA NDA019991 REMEDYREPACK INC. INSULIN HUMAN 100 [USP'U]/mL Insulin [Chemical/Ingredient],Insulin [EPC] 52125-415_4db2dc6a-a89e-497b-bc23-4f3d57e899f4 52125-415 HUMAN PRESCRIPTION DRUG Humulin 70/30 70/30 Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 20130612 NDA NDA019717 REMEDYREPACK INC. INSULIN HUMAN 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin [EPC] 52125-416_0c92b3d0-8c26-42ff-8788-7e050db63038 52125-416 HUMAN PRESCRIPTION DRUG Lantus insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20131121 NDA NDA021081 REMEDYREPACK INC. INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 52125-416_add8d95a-6943-4dc5-bc75-5d0c2d458aef 52125-416 HUMAN PRESCRIPTION DRUG Lantus insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20130612 NDA NDA021081 REMEDYREPACK INC. INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 52125-417_dcc1fcd9-6569-4d74-bad1-7ac626f66450 52125-417 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20130515 ANDA ANDA090797 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 52125-418_8d8ea6d7-80ac-4fb8-a4b3-69c40657dadf 52125-418 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20130604 ANDA ANDA040353 REMEDYREPACK INC. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 52125-419_846e4db4-fed7-47ff-af23-c36d39dfb603 52125-419 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20130515 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-419_a699e002-63a4-4cf3-85db-a77cbb4aaff0 52125-419 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20130515 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-420_4d809e1e-66bb-4648-ab99-a6398aca2667 52125-420 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 20130515 ANDA ANDA201407 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 52125-420_7bf90907-7a47-4746-9f26-86f6000ac81a 52125-420 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 20130524 ANDA ANDA201407 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 52125-422_8e72f200-ac3b-4ddd-ac1c-d09041319f28 52125-422 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130515 ANDA ANDA076813 REMEDYREPACK INC. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 52125-424_4c967259-5e26-46a6-b709-4cfbc20210ef 52125-424 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium sulfacetamide sodium SOLUTION/ DROPS OPHTHALMIC 20131203 ANDA ANDA040066 REMEDYREPACK INC. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 52125-424_db752cd8-43a0-4680-a72f-b454b3ade631 52125-424 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium sulfacetamide sodium SOLUTION/ DROPS OPHTHALMIC 20130613 ANDA ANDA040066 REMEDYREPACK INC. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 52125-426_3374535e-ed02-451b-b25c-a2d592afdeeb 52125-426 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20130515 ANDA ANDA075479 REMEDYREPACK INC. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 52125-427_5df0c672-1871-4264-9825-440ee73facdf 52125-427 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20130610 ANDA ANDA076002 REMEDYREPACK INC. BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE .5; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 52125-428_2d25bf91-1260-49c8-92e2-9fd5250a7bcd 52125-428 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20130530 ANDA ANDA090467 REMEDYREPACK INC. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-428_f1f2f946-b519-4f86-b969-8acbc8cf81cd 52125-428 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20130515 ANDA ANDA090467 REMEDYREPACK INC. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-429_0afe6461-a9e5-4d64-81bb-bcb68568e67b 52125-429 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20130705 ANDA ANDA077912 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-430_da0379cd-5613-483d-8610-f434c750f4c2 52125-430 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20130515 ANDA ANDA078428 REMEDYREPACK INC. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-431_9965f2d0-9fde-4715-96a5-11f4ba760bde 52125-431 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20130515 ANDA ANDA040103 REMEDYREPACK INC. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 52125-432_cab513f3-6d1e-43bc-bf31-033baca6edc6 52125-432 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20130515 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-433_2565166d-2a4a-4d5b-8d55-7a24fab04d25 52125-433 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20130515 ANDA ANDA065055 REMEDYREPACK INC. DOXYCYCLINE 100 mg/1 52125-433_25ec0fb6-d6b5-4e9f-a07a-181652af380b 52125-433 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20131204 ANDA ANDA065055 REMEDYREPACK INC. DOXYCYCLINE 100 mg/1 52125-433_49f372ce-3574-4f8d-83a2-9d6722365afd 52125-433 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20130529 ANDA ANDA065055 REMEDYREPACK INC. DOXYCYCLINE 100 mg/1 52125-433_9d6c3686-446d-4bc0-842d-a8442b385775 52125-433 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20130529 ANDA ANDA065055 REMEDYREPACK INC. DOXYCYCLINE 100 mg/1 52125-433_9ef81ea6-f335-40c2-809f-ad12f70ea36b 52125-433 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20130529 ANDA ANDA065055 REMEDYREPACK INC. DOXYCYCLINE 100 mg/1 52125-433_ff45b5bf-55e3-4c94-9035-026b21e2d23c 52125-433 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20140401 ANDA ANDA065055 REMEDYREPACK INC. DOXYCYCLINE 100 mg/1 52125-434_1d48c255-efd7-4ca9-bc9e-50dfabe1d41b 52125-434 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20130515 ANDA ANDA063029 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 52125-435_db55e9fb-13de-40b1-9a08-27aafc806242 52125-435 HUMAN PRESCRIPTION DRUG Renagel Renagel TABLET ORAL 20130515 NDA NDA021179 REMEDYREPACK INC. SEVELAMER HYDROCHLORIDE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 52125-436_408c3710-e480-42c5-ad78-87552286a78c 52125-436 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20130515 ANDA ANDA091416 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-436_6b80c0c2-01f7-4d86-bc08-3eee71e0b72d 52125-436 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20130515 ANDA ANDA091416 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-437_9de4201f-607d-435c-9a4b-8e15dffa6926 52125-437 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20130515 ANDA ANDA091650 REMEDYREPACK INC. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52125-438_cbecd800-b7cc-4f14-b0b6-26c6ecfb2157 52125-438 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20130617 ANDA ANDA018851 REMEDYREPACK INC. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-440_416fd51c-4afe-4f19-a231-1c26493e90aa 52125-440 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130515 ANDA ANDA090700 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52125-441_0d2b0164-ba53-492b-b6b6-b31ceab9f34e 52125-441 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130516 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-441_2ecc4af0-ff48-4a7e-b773-e5e42756124d 52125-441 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130524 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-442_dcfb7274-d6be-4e45-9cd3-f967e5595f84 52125-442 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130813 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-443_0d617353-29d6-4b43-928c-b5e09c1e45c0 52125-443 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130516 ANDA ANDA076063 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-444_d6690a06-6b9a-483e-aada-7a217dfcd990 52125-444 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130603 ANDA ANDA077127 REMEDYREPACK INC. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-445_4af33763-1d8c-493a-a089-c33512e7f8f2 52125-445 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate CREAM TOPICAL 20131031 NDA NDA018861 REMEDYREPACK INC. BETAMETHASONE VALERATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52125-445_bd0efcfa-d87f-4670-bc24-8319c0cae73f 52125-445 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate CREAM TOPICAL 20130610 NDA NDA018861 REMEDYREPACK INC. BETAMETHASONE VALERATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52125-446_3ca09498-1fe6-4f27-ab90-39abe5366872 52125-446 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20130516 ANDA ANDA040416 REMEDYREPACK INC. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-447_6e27f80f-781a-45fc-895f-154715501a03 52125-447 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20130813 ANDA ANDA076187 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-448_358f4925-0143-4d92-90cb-f31151066fa7 52125-448 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20130517 ANDA ANDA040416 REMEDYREPACK INC. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-449_ecfb85ac-9913-4228-8588-555aa27b1f0c 52125-449 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20130517 ANDA ANDA040416 REMEDYREPACK INC. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-450_f09190df-a03c-40de-841b-373faf92ae5b 52125-450 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20130517 ANDA ANDA040416 REMEDYREPACK INC. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-451_a6a5f6fa-8bf0-4e3b-a14a-3c818e129044 52125-451 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20130517 ANDA ANDA040416 REMEDYREPACK INC. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-452_b05c6f18-9566-44a9-8fab-f81d6cf37f37 52125-452 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20130520 ANDA ANDA090528 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-453_040b6387-10e8-4ac4-a3bb-91f021866a06 52125-453 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 20130522 ANDA ANDA071198 REMEDYREPACK INC. LEUCOVORIN CALCIUM 5 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 52125-454_a4533b1e-463f-49b9-863f-fdf3f9001c55 52125-454 HUMAN PRESCRIPTION DRUG BACITRACIN BACITRACIN OINTMENT OPHTHALMIC 20130610 ANDA ANDA061212 REMEDYREPACK INC. BACITRACIN 500 [iU]/g Decreased Cell Wall Synthesis & Repair [PE] 52125-455_61dd6c79-2c0a-4881-b618-681bef8d4038 52125-455 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20130522 ANDA ANDA073589 REMEDYREPACK INC. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 52125-456_0feaa24d-0935-46d2-b189-c4f5db51c5bd 52125-456 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20130610 ANDA ANDA065465 REMEDYREPACK INC. CEFTRIAXONE SODIUM 1 g/10mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52125-457_69038fea-a5f0-4235-9548-edd6892c15fb 52125-457 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20130520 ANDA ANDA062676 REMEDYREPACK INC. DOXYCYCLINE HYCLATE 100 mg/1 52125-457_9cc959e9-30d1-4044-bf59-1f7bacf851d2 52125-457 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20130520 ANDA ANDA062676 REMEDYREPACK INC. DOXYCYCLINE HYCLATE 100 mg/1 52125-457_b3410428-6018-4e5c-873b-bee150b4b251 52125-457 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20130522 ANDA ANDA062676 REMEDYREPACK INC. DOXYCYCLINE HYCLATE 100 mg/1 52125-459_7ba17e0d-7c22-4e03-8c0d-b6304a0887c3 52125-459 HUMAN PRESCRIPTION DRUG NASONEX Mometasone furoate monohydrate SPRAY, METERED NASAL 20130613 NDA NDA020762 REMEDYREPACK INC. MOMETASONE FUROATE MONOHYDRATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 52125-460_8d73d716-6a99-40a8-a3bc-901fc6b1d341 52125-460 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130522 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-461_001661c8-840a-4719-80fa-6dc1785bb323 52125-461 HUMAN PRESCRIPTION DRUG GENTAMICIN SULFATE gentamicin sulfate SOLUTION/ DROPS OPHTHALMIC 20131205 ANDA ANDA062452 REMEDYREPACK INC. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 52125-461_21d22632-9f65-47e7-9689-e0b1411f2a15 52125-461 HUMAN PRESCRIPTION DRUG GENTAMICIN SULFATE gentamicin sulfate SOLUTION/ DROPS OPHTHALMIC 20130705 ANDA ANDA062452 REMEDYREPACK INC. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 52125-462_1f6e0764-4c8c-4940-b9e8-f07ad0b459c5 52125-462 HUMAN PRESCRIPTION DRUG VENTOLINHFA HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20130610 NDA NDA020983 REMEDYREPACK INC. ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 52125-463_6e0e43f1-cd1a-4be6-b88f-90f31841a391 52125-463 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20130522 ANDA ANDA076317 REMEDYREPACK INC. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-465_c4c83c7c-fe5a-4911-a7f6-602cda1a6d8d 52125-465 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20130522 ANDA ANDA077797 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 52125-466_3c9f0a10-1f9e-4c57-bd8c-2e27ed6cc917 52125-466 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20130522 NDA NDA018413 REMEDYREPACK INC. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 52125-467_a667b6c4-a75c-444c-9e90-606115042a5a 52125-467 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20130522 ANDA ANDA040416 REMEDYREPACK INC. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-468_066e36d9-8459-4fa8-8fc5-6fdf7ae70d04 52125-468 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130522 ANDA ANDA090415 REMEDYREPACK INC. ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 52125-470_9f846a32-20e0-4871-a562-000efee1151a 52125-470 HUMAN PRESCRIPTION DRUG LATANOPROST LATANOPROST SOLUTION/ DROPS OPHTHALMIC 20130612 ANDA ANDA090887 REMEDYREPACK INC. LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 52125-471_84c99b56-187c-42fb-8075-226533c22084 52125-471 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20130603 ANDA ANDA065062 REMEDYREPACK INC. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 52125-472_569e4243-f09f-41c9-8215-6cfee87c638e 52125-472 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20130603 ANDA ANDA075113 REMEDYREPACK INC. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-473_6b7cd36d-b094-48c7-b930-b65483c1b8f5 52125-473 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20130708 ANDA ANDA090528 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-474_2f0431f5-f1ca-4ff3-bf63-2ada2dae0ffa 52125-474 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20130522 ANDA ANDA040627 REMEDYREPACK INC. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 52125-474_ced38c3d-c2fa-48bf-bb61-c9d20caad67a 52125-474 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20131029 ANDA ANDA040627 REMEDYREPACK INC. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 52125-475_49e1078a-8659-408d-b83e-78a415255d24 52125-475 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION OPHTHALMIC 20131203 NDA NDA020330 REMEDYREPACK INC. TIMOLOL MALEATE 6.8 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-477_029f288b-a70c-4ad7-ba4a-f3b1a0c91ad2 52125-477 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20130522 ANDA ANDA077903 REMEDYREPACK INC. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] 52125-477_02c151c7-f822-43dd-9053-13ed4dbab120 52125-477 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20130905 ANDA ANDA077903 REMEDYREPACK INC. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] 52125-478_20b15521-095f-4400-9ca4-905c72e4594a 52125-478 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20130522 ANDA ANDA076900 REMEDYREPACK INC. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-478_5e65f195-dfd8-4580-b0bb-0a81da30bcd1 52125-478 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20130524 ANDA ANDA076900 REMEDYREPACK INC. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-479_7edf23d1-746d-4062-9cd4-f7f006c2f4b4 52125-479 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20131112 ANDA ANDA074550 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-479_9435c5fa-5340-474e-8cdb-625847580190 52125-479 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20130522 ANDA ANDA074550 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-480_83aba47b-8aa1-493d-8665-483068f01f3d 52125-480 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130624 ANDA ANDA077321 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-480_9d28c55c-3fc3-4612-8871-4318492249f1 52125-480 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131105 ANDA ANDA077321 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-480_c290db20-101f-4633-bff4-51134dacd1de 52125-480 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20140915 ANDA ANDA077321 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-481_201d0b9a-4760-4702-93e1-856104303189 52125-481 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20130530 ANDA ANDA074550 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-481_7e32f283-f8ae-4d06-8c0c-19dd8ca5ed45 52125-481 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20131112 ANDA ANDA074550 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-482_9e6ed24d-5eb9-4929-9bd5-507a9fce3384 52125-482 HUMAN PRESCRIPTION DRUG TIMOLOL MALEATE timolol maleate SOLUTION/ DROPS OPHTHALMIC 20140109 ANDA ANDA074747 REMEDYREPACK INC. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-482_e2bfa877-ef62-4b39-a2c2-413836decf0c 52125-482 HUMAN PRESCRIPTION DRUG TIMOLOL MALEATE timolol maleate SOLUTION/ DROPS OPHTHALMIC 20131203 ANDA ANDA074747 REMEDYREPACK INC. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-483_74e8d2e9-744c-456f-98f8-8836fb4bd744 52125-483 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS TOPICAL 20130531 ANDA ANDA077689 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-484_cd7d7cfa-1b57-4215-8e3c-1a65880423e1 52125-484 HUMAN PRESCRIPTION DRUG PREDNISOLONE ACETATE prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 20130412 NDA AUTHORIZED GENERIC NDA017011 REMEDYREPACK INC. PREDNISOLONE ACETATE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52125-485_3e650aeb-c39a-47e8-9fa0-438b8dd85b24 52125-485 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20130522 ANDA ANDA090528 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-486_1d479f69-7aa7-4d19-8d80-2e5bc1e42ab1 52125-486 HUMAN PRESCRIPTION DRUG JANUMET SITAGLIPTIN and METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20130522 NDA NDA022044 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 500; 50 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient],Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 52125-487_7704871f-12cb-4053-b704-92d16b0b525e 52125-487 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 20130416 ANDA ANDA062364 REMEDYREPACK INC. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 52125-488_e09ccf1c-fc06-43e6-9dce-906ac41ef3f7 52125-488 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20130412 ANDA ANDA040039 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 1 mg/1 52125-489_64cb8a0e-2c73-4c8d-8374-91a009ea360c 52125-489 HUMAN PRESCRIPTION DRUG ofloxacin ofloxacin SOLUTION OPHTHALMIC 20131125 ANDA ANDA078559 REMEDYREPACK INC. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-490_9a0e54cb-8a5a-48ab-b6f9-598e9210f5e5 52125-490 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 20130412 ANDA ANDA081203 REMEDYREPACK INC. HYDROCORTISONE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52125-491_b36aeb5c-93bd-4fb2-b6ce-fe6ce3510ccb 52125-491 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20130927 ANDA ANDA074726 REMEDYREPACK INC. POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 52125-492_4892b2c7-4b50-42da-a587-24e57f4f6083 52125-492 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20130522 ANDA ANDA090493 REMEDYREPACK INC. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 52125-493_b1b0babf-3eae-431d-b5aa-67c157edb855 52125-493 HUMAN PRESCRIPTION DRUG JANUMET SITAGLIPTIN and METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20130522 NDA NDA022044 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE 1000; 50 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient],Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 52125-494_d149c11a-8303-4964-9cb2-fd14163e0c66 52125-494 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 20130522 NDA NDA020895 REMEDYREPACK INC. SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 52125-495_667453f2-94ee-4005-937e-c53d291cfb2a 52125-495 HUMAN PRESCRIPTION DRUG ketoconazole ketoconazole CREAM TOPICAL 20130415 ANDA ANDA076294 REMEDYREPACK INC. KETOCONAZOLE 20 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 52125-496_4dd6c7fa-74b1-4f5e-bebb-a41a7281231a 52125-496 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20130708 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-497_c14686ea-cfe5-43d4-ad14-cb12999bdd4a 52125-497 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20130522 ANDA ANDA090705 REMEDYREPACK INC. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-498_d60a1a4e-ed2f-4188-8035-e9a7947ef9c9 52125-498 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20130522 ANDA ANDA090637 REMEDYREPACK INC. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 52125-499_f4f2ac6d-1188-469c-9a96-e8ce9a0e9815 52125-499 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20130705 ANDA ANDA077912 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-501_a70fd1f0-4324-41a6-8676-dd0901aac853 52125-501 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20130522 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-502_5b1b66ff-f517-428c-8d6d-1b436776eeb4 52125-502 HUMAN PRESCRIPTION DRUG PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION OPHTHALMIC 20130415 NDA NDA200890 REMEDYREPACK INC. PILOCARPINE HYDROCHLORIDE 40 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 52125-503_d852d78a-25b7-4933-bbed-a56e9579069f 52125-503 HUMAN PRESCRIPTION DRUG Econazole Nitrate Econazole Nitrate CREAM TOPICAL 20130415 ANDA ANDA076479 REMEDYREPACK INC. ECONAZOLE NITRATE 10 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 52125-504_1ea20ecd-8329-4e73-a3ff-2182f4b9918f 52125-504 HUMAN PRESCRIPTION DRUG Diltiazem HydrochlorideExtended Release Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20130522 ANDA ANDA074984 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52125-505_1d84b6b8-cffb-48fc-895b-0d46b44420c7 52125-505 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20131204 ANDA ANDA075185 REMEDYREPACK INC. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-505_33fdc629-78ee-4ac1-a0f6-0e05523cf431 52125-505 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20130624 ANDA ANDA075185 REMEDYREPACK INC. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-506_0a679d49-d16f-4a21-aa60-07ff65241230 52125-506 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride Dorzolamide Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20131118 ANDA ANDA077846 REMEDYREPACK INC. DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] 52125-506_c6cfcb46-dd27-49f0-9c0e-f8cc9d8c7852 52125-506 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride Dorzolamide Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20140109 ANDA ANDA077846 REMEDYREPACK INC. DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] 52125-507_5ad45abf-cc46-4b2f-80a9-c778b3db8721 52125-507 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20131231 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-507_cfc06e20-de93-42da-85a6-087de67dd295 52125-507 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20130708 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-508_2a8f7178-eb8c-4716-b946-dd8282b58f6e 52125-508 HUMAN PRESCRIPTION DRUG Bupropion HydrochlorideXL XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130603 ANDA ANDA077715 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 52125-509_d0b8b990-6eb0-4ad0-925d-1cc8ca0abdeb 52125-509 HUMAN PRESCRIPTION DRUG Brimonidine Tartrate Brimonidine Tartrate SOLUTION/ DROPS OPHTHALMIC 20130624 ANDA ANDA076260 REMEDYREPACK INC. BRIMONIDINE TARTRATE 2 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 52125-509_e2dca600-c722-439f-9478-326cb9c98d0e 52125-509 HUMAN PRESCRIPTION DRUG Brimonidine Tartrate Brimonidine Tartrate SOLUTION/ DROPS OPHTHALMIC 20131031 ANDA ANDA076260 REMEDYREPACK INC. BRIMONIDINE TARTRATE 2 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 52125-510_6bed3f8a-3ae0-4a7b-8784-eef7aec539f6 52125-510 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20130219 ANDA ANDA078155 REMEDYREPACK INC. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52125-512_42af70ee-2271-4b00-bd8c-f048e88b31af 52125-512 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride and Timolol Maleate Dorzolamide Hydrochloride and Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20130604 ANDA ANDA077847 REMEDYREPACK INC. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-513_bfa3cf39-dc34-4235-abc5-fd2cf780d683 52125-513 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20130524 ANDA ANDA090493 REMEDYREPACK INC. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 52125-514_cbaa48d4-2251-46c1-98ba-52a9bef0fde6 52125-514 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 20130522 ANDA ANDA073665 REMEDYREPACK INC. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-515_15db43b1-1b11-483e-8de8-28a4c927096c 52125-515 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130415 NDA NDA011856 REMEDYREPACK INC. METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52125-517_0b14cbf1-0ed5-411b-8396-7b88da80b20e 52125-517 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 20130624 ANDA ANDA085223 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52125-517_78a947d7-bcb8-4f6d-b13d-257e281d5046 52125-517 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 20140206 ANDA ANDA085223 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52125-518_9d50b584-d6aa-4731-bfe8-f5ec17db72d4 52125-518 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130821 ANDA ANDA040807 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 52125-519_db9c31e6-7dea-4f9a-95ea-2650475835ec 52125-519 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130708 ANDA ANDA078542 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 52125-521_08fd6347-e76f-43ab-ac50-19834f4745c3 52125-521 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20130523 ANDA ANDA074644 REMEDYREPACK INC. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-521_61655625-e4f2-4e63-8ff6-9913b3cdaaed 52125-521 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20141030 ANDA ANDA074644 REMEDYREPACK INC. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-521_78e1a3c8-397d-4983-ab33-6470fc490c0b 52125-521 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20130524 ANDA ANDA074644 REMEDYREPACK INC. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-522_e2039120-ed87-4d1a-9dda-a4e9878f8691 52125-522 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130523 ANDA ANDA085162 REMEDYREPACK INC. PREDNISONE 10 mg/1 52125-523_ca765526-2342-47d9-9c7a-01f867fc279e 52125-523 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 20131203 ANDA ANDA085692 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 5 mg/g 52125-523_dc7a76fc-c6de-40ad-87ba-ec16139ef153 52125-523 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 20140203 ANDA ANDA085692 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 5 mg/g 52125-524_edae38b8-ccad-462d-b139-eba507d1d26f 52125-524 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20130523 ANDA ANDA075479 REMEDYREPACK INC. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 52125-525_ab0b8b02-a278-48da-971d-fb09f5c37a2a 52125-525 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride TABLET, FILM COATED ORAL 20130524 NDA NDA021085 REMEDYREPACK INC. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-525_b7c38d62-2b75-424e-a847-5464751efa5d 52125-525 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride TABLET, FILM COATED ORAL 20130708 NDA NDA021085 REMEDYREPACK INC. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-526_708440c8-2b23-428e-b71a-881319134bca 52125-526 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION OPHTHALMIC 20130415 ANDA ANDA078434 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-528_c00dad43-f4ad-4b1f-b934-09a277899687 52125-528 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine maleate TABLET ORAL 20130603 ANDA ANDA040268 REMEDYREPACK INC. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-529_4c21b9e2-d27a-48fd-8fa2-dc51a1fcf34b 52125-529 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR 20130411 ANDA ANDA040737 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-530_0f1e69c2-dabb-4298-aedd-df84115cc205 52125-530 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20131029 NDA NDA018487 REMEDYREPACK INC. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 52125-530_2c678cd4-b60e-4a31-92c9-8b5e19066e85 52125-530 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20130523 NDA NDA018487 REMEDYREPACK INC. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 52125-531_87334c9e-93f5-4971-8822-866110aa1072 52125-531 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20140916 NDA NDA018487 REMEDYREPACK INC. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 52125-531_a1ad23a2-5d18-4814-8e07-ce7ef7973b49 52125-531 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20130523 NDA NDA018487 REMEDYREPACK INC. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 52125-532_a825c600-5ce0-4322-b5ca-5fe1ae70fe4a 52125-532 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone atenolol and chlorthalidone TABLET ORAL 20130523 ANDA ANDA074203 REMEDYREPACK INC. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 52125-533_18fc78d9-801e-489e-8738-e2e71aab130b 52125-533 HUMAN PRESCRIPTION DRUG PROAIRHFA HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20130604 NDA NDA021457 REMEDYREPACK INC. ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 52125-534_0c225a2a-5c14-4779-9680-0ce1e038b93b 52125-534 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20130523 ANDA ANDA090637 REMEDYREPACK INC. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 52125-534_bdce2437-97e6-409f-a101-a64ac6e9bf52 52125-534 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20140418 ANDA ANDA090637 REMEDYREPACK INC. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 52125-535_f01e937b-84b1-425e-8320-3211aaf26e5c 52125-535 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20131029 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-535_f0a14b3c-5221-403c-bb3a-e60b84bf2cb5 52125-535 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130813 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-536_af7ee196-b07a-45e3-8122-cc498a01e486 52125-536 HUMAN PRESCRIPTION DRUG Tobramycin and Dexamethasone Tobramycin and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 20130603 ANDA ANDA064134 REMEDYREPACK INC. DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 52125-537_a6581095-a5f5-477a-ac3d-fc7ebe55cf14 52125-537 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS TOPICAL 20130423 ANDA ANDA077689 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-537_af3365d7-913f-43e5-a31f-86b41748f91f 52125-537 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS TOPICAL 20131118 ANDA ANDA077689 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-538_ac72372a-6599-4cfe-8810-1c87f11b3017 52125-538 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 20130506 ANDA ANDA064067 REMEDYREPACK INC. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-539_630bbf8c-16cd-4d79-9980-b7f55aa32515 52125-539 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20130523 ANDA ANDA065211 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-539_74728ec8-ddd1-4bb6-ad01-7d09be5ee645 52125-539 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20130524 ANDA ANDA065211 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-539_9b1e56a5-6c07-4242-965b-ee9ee1cedd70 52125-539 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20141013 ANDA ANDA065211 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-539_d65c5ad2-9f79-4082-8088-e008dfc2ea9d 52125-539 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20141013 ANDA ANDA065211 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-540_4a3a8b6a-5c86-4c22-ac6c-d125ed670d6c 52125-540 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 20130530 NDA AUTHORIZED GENERIC NDA019949 REMEDYREPACK INC. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 52125-540_5da23332-0e03-4fad-ab2d-e42bd2d2e407 52125-540 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 20130523 NDA AUTHORIZED GENERIC NDA019949 REMEDYREPACK INC. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 52125-540_de89d290-2aff-41ba-845b-a03d02b52344 52125-540 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 20141230 NDA AUTHORIZED GENERIC NDA019949 REMEDYREPACK INC. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 52125-541_0b2667d7-342f-4f3d-b52a-b28b53d6a4dc 52125-541 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130523 ANDA ANDA078596 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-541_40346c0d-dd3b-4c77-b822-64a2b5f1afc3 52125-541 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130524 ANDA ANDA078596 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-542_c4f36010-f28c-4765-83f0-0d1e374fa05f 52125-542 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20130523 ANDA ANDA040779 REMEDYREPACK INC. ACETAMINOPHEN; CODEINE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 52125-544_23109c79-2bd9-4025-bffd-cac95877d7e3 52125-544 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20130523 ANDA ANDA063029 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 52125-544_a6f1b5f3-f415-4787-806b-3474d08c8b88 52125-544 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20130524 ANDA ANDA063029 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 52125-545_144eb44c-3310-4f27-a079-80a6d25d446c 52125-545 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20140109 ANDA ANDA065085 REMEDYREPACK INC. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 52125-545_92809782-f2f0-4f08-9c75-caa080b3f811 52125-545 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20131122 ANDA ANDA065085 REMEDYREPACK INC. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 52125-546_5883272b-c855-47ef-a893-c733e647155c 52125-546 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20131217 ANDA ANDA065230 REMEDYREPACK INC. CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52125-546_616a1c16-fc33-476c-acea-9ca70156b524 52125-546 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130506 ANDA ANDA065230 REMEDYREPACK INC. CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52125-548_1eb71730-5376-40a5-84bf-8e0503d9a7aa 52125-548 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20130523 ANDA ANDA077987 REMEDYREPACK INC. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52125-549_a18e6371-306f-4c0c-9728-88b65c3d90e1 52125-549 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20130701 ANDA ANDA076341 REMEDYREPACK INC. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52125-549_d3164636-2a92-4da7-8104-b4a18320e6d7 52125-549 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20130523 ANDA ANDA076341 REMEDYREPACK INC. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52125-550_ca24ae9d-5ee2-486d-82cf-6e4e53679352 52125-550 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130523 ANDA ANDA075155 REMEDYREPACK INC. ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 52125-553_ae35f18f-2c4b-4146-aad6-821136b9c139 52125-553 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20130523 ANDA ANDA076286 REMEDYREPACK INC. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 52125-555_22d252a9-e08a-49fd-a32b-fc8fc23d4af7 52125-555 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130523 ANDA ANDA085161 REMEDYREPACK INC. PREDNISONE 20 mg/1 52125-556_a9ef990c-2cef-4c10-ae86-a6dbd0a9f030 52125-556 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130523 ANDA ANDA075932 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 52125-557_e0cf47dd-4b91-43c3-aff1-7d586bb306a9 52125-557 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20130523 ANDA ANDA070184 REMEDYREPACK INC. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 52125-559_18a6076c-e790-4bf1-9c4b-9a28a7fb7b40 52125-559 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20131205 ANDA ANDA091416 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-559_bf8b1abb-325e-42c1-b644-5f047f70ac90 52125-559 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20130708 ANDA ANDA091416 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-559_eb57509d-ba06-4fe7-8fc8-dd9d9f37f736 52125-559 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20130701 ANDA ANDA091416 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-559_f3d3be11-0a42-4c69-994f-c0c4ddefc963 52125-559 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20130708 ANDA ANDA091416 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-561_5110333b-244d-40b1-a7de-bd80a9c43ee0 52125-561 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20141124 ANDA ANDA077851 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-561_58adb0ce-a92f-41f6-8c41-38996936e420 52125-561 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20130523 ANDA ANDA077851 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-562_672159a0-f48a-4e9c-b5de-26015606080a 52125-562 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 20130523 ANDA ANDA040159 REMEDYREPACK INC. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 52125-564_86775530-8e6b-4861-9512-fdf427add4bd 52125-564 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20131202 NDA NDA018803 REMEDYREPACK INC. SODIUM CHLORIDE 9 mg/mL 52125-564_b1df76c5-0e4f-4867-ac60-b9aebed51379 52125-564 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20131202 NDA NDA018803 REMEDYREPACK INC. SODIUM CHLORIDE 9 mg/mL 52125-564_b81471b5-a7f1-4cfb-8609-4b7bbb25c2cb 52125-564 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20130501 NDA NDA018803 REMEDYREPACK INC. SODIUM CHLORIDE 9 mg/mL 52125-566_137c08a0-da5a-4db1-b06c-757b79b73002 52125-566 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20140226 ANDA ANDA091179 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-566_dce9aae3-df71-4b19-9407-dc8a37357cae 52125-566 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20130523 ANDA ANDA091179 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-567_77f759d0-d892-4b2f-8efc-91f03ab92d4b 52125-567 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130708 ANDA ANDA077157 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-568_3c7e1043-59cc-4acf-95aa-1e00e0414b50 52125-568 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20140324 ANDA ANDA078152 REMEDYREPACK INC. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-568_3d5f7f9a-12aa-4609-8b16-4c1664ecc44f 52125-568 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20130624 ANDA ANDA078152 REMEDYREPACK INC. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-568_55b86af4-3b68-4f90-93c8-449a86690a7f 52125-568 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20141104 ANDA ANDA078152 REMEDYREPACK INC. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-568_7fb56814-9cb1-4530-b832-ee2f02e51f32 52125-568 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20130610 ANDA ANDA078152 REMEDYREPACK INC. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-569_5ee33981-d50b-4821-aae9-2efecd99d09a 52125-569 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20141029 ANDA ANDA077557 REMEDYREPACK INC. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-569_cb27a2dc-864d-4516-abf7-489a826844a7 52125-569 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20130523 ANDA ANDA077557 REMEDYREPACK INC. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-569_e2705d22-08f9-4a8b-abf7-6aaa96eecd39 52125-569 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20130821 ANDA ANDA077557 REMEDYREPACK INC. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-569_fbb457db-bba5-4d4a-a969-fc5ca9a7c4ef 52125-569 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20141014 ANDA ANDA077557 REMEDYREPACK INC. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-570_4ced39b3-7915-4dc2-b454-e02a71c95c85 52125-570 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET ORAL 20130523 ANDA ANDA079112 REMEDYREPACK INC. FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 52125-570_9bc50133-ce70-4d1d-8b18-18bd80419bc0 52125-570 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET ORAL 20130524 ANDA ANDA079112 REMEDYREPACK INC. FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 52125-571_17b02f94-63a0-4a0a-b457-1cd26a6b28bd 52125-571 HUMAN PRESCRIPTION DRUG SSD Cream Silver Sulfadiazine CREAM TOPICAL 20131202 NDA NDA018578 REMEDYREPACK INC. SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 52125-571_64bc1c06-1801-4496-8afe-d53d8af6a0b0 52125-571 HUMAN PRESCRIPTION DRUG SSD Cream Silver Sulfadiazine CREAM TOPICAL 20130501 NDA NDA018578 REMEDYREPACK INC. SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 52125-572_8532d057-d994-4f42-9902-beb261003585 52125-572 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20130708 ANDA ANDA090441 REMEDYREPACK INC. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 52125-573_4ff81c88-da6c-4c2c-a22e-d053eeb9ceea 52125-573 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20130301 ANDA ANDA074305 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-574_08510b31-5370-4c39-97ca-e8e8042d9ead 52125-574 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20131125 ANDA ANDA077716 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-574_b8ada536-2444-4e72-b285-b122e969ba9f 52125-574 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20130705 ANDA ANDA077716 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-574_e9461dce-67fe-4acd-b5e9-71a2354f2cf3 52125-574 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20131205 ANDA ANDA077716 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-575_4a1f7852-0314-4f20-b0de-b92ff9b89369 52125-575 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20130524 ANDA ANDA040416 REMEDYREPACK INC. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-576_074bc74b-f2c1-4a35-bfed-c91f5dc5a726 52125-576 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20130524 ANDA ANDA077058 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 52125-576_1e9f0f76-42ea-43b0-98ac-f8d8b70935bd 52125-576 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20131029 ANDA ANDA077058 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 52125-577_12d4c6b3-48f9-4d32-a97b-5e0035dbe622 52125-577 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20130506 ANDA ANDA075638 REMEDYREPACK INC. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 52125-577_757750db-ac99-405b-b503-84977f30651c 52125-577 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20140204 ANDA ANDA075638 REMEDYREPACK INC. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 52125-578_d23150f1-d2ca-4789-bf2d-7767a9e9ac34 52125-578 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride TABLET ORAL 20130524 ANDA ANDA040659 REMEDYREPACK INC. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 52125-579_91ff4771-31e5-43e4-b797-638c1fdc220f 52125-579 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20140801 ANDA ANDA040807 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 52125-579_d5faa0f2-613e-4cd6-9c4c-15e84c3f553c 52125-579 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130708 ANDA ANDA040807 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 52125-580_142a37c3-0f09-4b23-aed4-8ae9eeb972e3 52125-580 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20140220 ANDA ANDA091416 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-580_6a5a48b9-e6d6-4743-bb24-bd006bf00cae 52125-580 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20130624 ANDA ANDA091416 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-580_7795cbf1-1380-4ae5-a541-a7436bf1959e 52125-580 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20130708 ANDA ANDA091416 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-580_ba6d68b4-9ede-40b3-85d9-355357b7c47b 52125-580 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20140416 ANDA ANDA091416 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-581_4e2260ed-7523-45f6-b122-e4823338d744 52125-581 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20130528 ANDA ANDA040416 REMEDYREPACK INC. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-582_3c766177-d04e-4b84-ab07-3e32d267c201 52125-582 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20130708 ANDA ANDA063009 REMEDYREPACK INC. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 52125-583_23616f0b-477f-4a9d-af18-d0f977924f18 52125-583 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20130528 ANDA ANDA090937 REMEDYREPACK INC. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-584_b4a8856d-747e-4090-b2b7-eb9fc27d03d9 52125-584 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET ORAL 20130528 ANDA ANDA089424 REMEDYREPACK INC. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 52125-585_6b845f20-8af6-4bfc-a1d1-0c94745762a9 52125-585 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20130528 NDA NDA008678 REMEDYREPACK INC. ISONIAZID 300 mg/1 Antimycobacterial [EPC] 52125-586_d89d5e48-2d5c-485f-a385-3c6b9b65b894 52125-586 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20130528 ANDA ANDA079009 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-587_bc3fe0a0-0988-4f05-84a9-607fcb9a76fa 52125-587 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Codeine Phosphate Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20130604 ANDA ANDA040151 REMEDYREPACK INC. CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-588_0928f3e7-eec1-450a-8b5e-3628a4eb5bfa 52125-588 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20130604 ANDA ANDA075693 REMEDYREPACK INC. IPRATROPIUM BROMIDE ANHYDROUS .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52125-590_3ad8917a-8a10-4d95-bbb4-dcb05426822a 52125-590 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20130528 ANDA ANDA075994 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-591_8e422aff-bdca-4306-aea6-c7315cabb2fb 52125-591 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20130528 ANDA ANDA074151 REMEDYREPACK INC. CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 52125-592_36ac8294-8a0e-4be5-bcba-526106c5f260 52125-592 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20130528 ANDA ANDA078777 REMEDYREPACK INC. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-593_a2cd36fe-3048-4a96-ab29-425721bbad21 52125-593 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20130528 ANDA ANDA075994 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-594_e11b91b2-91f9-4295-b872-3e024e2233ae 52125-594 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130813 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-595_5a7fc86c-0c3c-43c0-914c-11fd8ce310e3 52125-595 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130813 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-596_ff0dea8e-47b4-47f4-a826-02c1eb2680b9 52125-596 HUMAN PRESCRIPTION DRUG Prometh with Codeine promethazine hydrochloride and codeine phosphate SYRUP ORAL 20130708 ANDA ANDA088763 REMEDYREPACK INC. CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-597_c42d7aac-86d2-413b-9cce-5e161f7c7120 52125-597 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20130528 ANDA ANDA072575 REMEDYREPACK INC. PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-598_ea643012-1f0e-4fee-9608-638ef86943ad 52125-598 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20130528 ANDA ANDA077745 REMEDYREPACK INC. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 52125-599_dc5924d9-44b7-45c6-8b6b-fa774f51e74a 52125-599 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20130604 ANDA ANDA085966 REMEDYREPACK INC. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 52125-600_24befde4-dc4d-407f-9126-b975b64489e6 52125-600 HUMAN PRESCRIPTION DRUG Loratadineantihistamine antihistamine Loratadine TABLET ORAL 20130529 ANDA ANDA076301 REMEDYREPACK INC. LORATADINE 10 mg/1 52125-600_2d879b5a-9d97-4e27-b72f-795f25077506 52125-600 HUMAN PRESCRIPTION DRUG Loratadineantihistamine antihistamine Loratadine TABLET ORAL 20130528 ANDA ANDA076301 REMEDYREPACK INC. LORATADINE 10 mg/1 52125-601_21979869-0695-43d5-9eee-94cba710f4ab 52125-601 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20140131 ANDA ANDA075638 REMEDYREPACK INC. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 52125-601_d7382ccd-d758-4bee-b72c-eb28faeac22f 52125-601 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20130604 ANDA ANDA075638 REMEDYREPACK INC. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 52125-602_71d48636-fd69-41d6-8ca1-63277711209d 52125-602 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 20131122 ANDA ANDA064065 REMEDYREPACK INC. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 52125-602_b4d04002-484d-4f30-9e3f-f8258e3c06b5 52125-602 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 20130606 ANDA ANDA064065 REMEDYREPACK INC. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 52125-603_f6a0bbf5-eb9e-4a9c-8047-c0117588fefd 52125-603 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET ORAL 20130528 ANDA ANDA089424 REMEDYREPACK INC. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 52125-604_f4984dfd-abee-4002-a95d-123fa4b9da99 52125-604 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20130528 ANDA ANDA077944 REMEDYREPACK INC. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-605_b0989508-1fab-4816-949b-3319098606ef 52125-605 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20130528 ANDA ANDA072575 REMEDYREPACK INC. PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-606_1372c2c3-8af8-49e3-9a4b-3cf188cf97e3 52125-606 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET ORAL 20130529 ANDA ANDA090061 REMEDYREPACK INC. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 52125-606_bf510a34-5ad7-4053-a9a8-cd87f962efa0 52125-606 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET ORAL 20130919 ANDA ANDA090061 REMEDYREPACK INC. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 52125-607_0f2103f5-7fcf-4da7-96f9-fd6b7ca58383 52125-607 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140416 ANDA ANDA076706 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-607_1f41205c-3cc5-4a17-b2b3-69ee250ef4a5 52125-607 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20130529 ANDA ANDA076706 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-608_13824699-b006-4db9-8daa-e28777541cd8 52125-608 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20130529 ANDA ANDA040627 REMEDYREPACK INC. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 52125-608_c9322822-1c0c-4171-8068-6095a9155cff 52125-608 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20130529 ANDA ANDA040627 REMEDYREPACK INC. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 52125-610_faaa7f9e-c956-49da-80fc-9c850977b1b5 52125-610 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130529 ANDA ANDA076813 REMEDYREPACK INC. ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 52125-611_23603bb1-8d29-423f-a5b1-97bcfe06dba0 52125-611 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20130731 ANDA ANDA074625 REMEDYREPACK INC. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52125-611_dc7edf69-c109-4e32-9d64-fbb8336b5720 52125-611 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20130529 ANDA ANDA074625 REMEDYREPACK INC. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52125-612_0eeb52bd-3f17-4b0f-835d-44ab17db6e9e 52125-612 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20131121 ANDA ANDA089644 REMEDYREPACK INC. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 10 ug/mL; mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-612_96cac9ab-4b59-4dd8-9dd5-51dfae82af22 52125-612 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20131121 ANDA ANDA089644 REMEDYREPACK INC. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 10 ug/mL; mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-612_9e8f3349-180a-4985-958a-006dd7ce26b7 52125-612 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20130705 ANDA ANDA089644 REMEDYREPACK INC. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 10 ug/mL; mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-613_2332ce3c-0df4-4929-b711-5da5cf371f69 52125-613 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20130529 NDA NDA021976 REMEDYREPACK INC. DARUNAVIR ETHANOLATE 800 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] 52125-614_7b2f2211-afc3-467f-afc9-e88bffb04f76 52125-614 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20130529 ANDA ANDA040416 REMEDYREPACK INC. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-615_6259f4d0-65ca-45e9-9c87-ba50752cbf61 52125-615 HUMAN PRESCRIPTION DRUG VERAMYST fluticasone furoate SPRAY, METERED NASAL 20130607 NDA NDA022051 REMEDYREPACK INC. FLUTICASONE FUROATE 27.5 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52125-616_61dd23bb-f25a-4c0d-aa9d-daf085ee2ebf 52125-616 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20130529 ANDA ANDA079009 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-617_1854ac9f-1011-4ae1-b2cf-a62f8edf102d 52125-617 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET, FILM COATED ORAL 20130529 ANDA ANDA090370 REMEDYREPACK INC. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 52125-617_b59b77c5-d214-4c16-8c87-320acf7c0acc 52125-617 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET, FILM COATED ORAL 20131204 ANDA ANDA090370 REMEDYREPACK INC. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 52125-618_7bd0ff5b-c834-48ff-a9f5-2787bade1e3a 52125-618 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION OROPHARYNGEAL 20130610 ANDA ANDA040708 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-618_fde9992e-2b3a-41ff-9b1e-5b514fff7294 52125-618 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION TOPICAL 20131121 ANDA ANDA040710 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-619_365049df-c689-4455-9ce6-3e57f67f844f 52125-619 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION INTRAMUSCULAR 20130813 ANDA ANDA087702 REMEDYREPACK INC. DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52125-620_51fefe45-b8ee-411f-94b5-0e22fe532146 52125-620 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20130529 ANDA ANDA091630 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 52125-621_a594d804-43f2-49df-92dd-b0e806496dbc 52125-621 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20130529 ANDA ANDA079009 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-622_9ec33b2c-bc46-409b-9152-10b3aa77db87 52125-622 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20130529 ANDA ANDA079009 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-624_3895c3bb-fd3f-4522-a7f9-a48aefb69da3 52125-624 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20131203 ANDA ANDA074806 REMEDYREPACK INC. PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] 52125-624_b45bc6ab-42c4-45ed-bf9c-e12493d2dbbd 52125-624 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20130604 ANDA ANDA074806 REMEDYREPACK INC. PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] 52125-626_ab9ab4eb-e0fa-42a0-b67e-9ddbad216d11 52125-626 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20140108 ANDA ANDA040489 REMEDYREPACK INC. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 52125-627_8a6aed19-666c-40b4-a78e-b1ff0d445c6f 52125-627 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20130610 ANDA ANDA078616 REMEDYREPACK INC. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] 52125-628_1c3df7a2-43e4-49d6-ba4c-ae500ba08939 52125-628 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20130823 ANDA ANDA078432 REMEDYREPACK INC. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-628_33c147b7-cfd6-45ef-934b-52e222b317c6 52125-628 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140710 ANDA ANDA078432 REMEDYREPACK INC. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-629_6428b25b-8ed1-430a-b53b-5c315bc8b054 52125-629 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20130529 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-630_0970e0ac-abdf-4fe7-89ed-b6ad51b600d9 52125-630 HUMAN PRESCRIPTION DRUG leader omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20130604 NDA NDA022032 REMEDYREPACK INC. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 52125-631_d469a56d-c07a-4377-9add-d1259882c13c 52125-631 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20130529 ANDA ANDA077745 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 52125-632_54084b32-2ced-42f0-b4a9-7ab1fec142d0 52125-632 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20130529 ANDA ANDA077745 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 52125-633_aa190409-fc29-4a3e-809b-da7474599be6 52125-633 HUMAN PRESCRIPTION DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20130606 NDA NDA022032 REMEDYREPACK INC. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 52125-634_0d00dd8e-5d5b-41c8-b858-117de704654e 52125-634 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20130705 ANDA ANDA076194 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-634_2abe04a2-661c-4d0f-97ce-ab2d662f940b 52125-634 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20131112 ANDA ANDA076194 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-635_56fa2966-6790-488b-8d99-0e564d96a1c1 52125-635 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR 20130610 ANDA ANDA077942 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-635_8b706b0e-5ce7-4159-bfa8-17960e1a822b 52125-635 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR 20131121 ANDA ANDA077942 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-635_9749ac72-093f-41ce-a57a-5516a5ac0c2e 52125-635 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR 20131121 ANDA ANDA077942 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-636_2960ecf3-b104-4096-8dcc-543003dee164 52125-636 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION INTRAMUSCULAR 20130610 ANDA ANDA080817 REMEDYREPACK INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 52125-636_d5971f2c-54f6-415b-aa92-eb45bebb2ecf 52125-636 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION INTRAMUSCULAR 20131118 ANDA ANDA080817 REMEDYREPACK INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 52125-637_e7a2f021-c298-4886-a225-c928595924de 52125-637 HUMAN PRESCRIPTION DRUG PROMETHEGAN PROMETHAZINE HYDROCHLORIDE SUPPOSITORY RECTAL 20130604 ANDA ANDA040428 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-638_6b358f3b-7efc-4361-8299-00ace147adb9 52125-638 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20131008 ANDA ANDA078558 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-638_f5b9a57f-2b90-4698-93ff-1bd7477ef7a9 52125-638 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20130530 ANDA ANDA078558 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-639_0aa872ac-bdbd-474a-a786-a114dacc960c 52125-639 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20130530 ANDA ANDA083426 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-639_393d7c04-7355-43f9-9a6d-8ce44c13a1b2 52125-639 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20131029 ANDA ANDA083426 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-639_c31d975e-518a-4f91-a673-a2b1d4b98103 52125-639 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20131205 ANDA ANDA083426 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-640_7a21e6e1-9b3e-4df9-8295-ede2a0d1fd80 52125-640 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION INTRAMUSCULAR 20130530 NDA AUTHORIZED GENERIC NDA020246 REMEDYREPACK INC. MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 52125-642_18354a51-e1c1-4b45-b2ee-0edaa9aea038 52125-642 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20130614 ANDA ANDA078925 REMEDYREPACK INC. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-644_d82c48fe-d7dc-49b5-82a4-f4dc3aa17dc7 52125-644 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20130701 ANDA ANDA076341 REMEDYREPACK INC. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52125-645_43dfcf15-628c-42a2-b76d-34ba7dcc93d2 52125-645 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20130701 ANDA ANDA070278 REMEDYREPACK INC. HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] 52125-646_cb3f4720-dfff-44ad-b68b-4d1876f54fd6 52125-646 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20130701 ANDA ANDA077537 REMEDYREPACK INC. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-647_02601eed-2300-4b82-996a-8fd5b291e84b 52125-647 HUMAN PRESCRIPTION DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL 20130617 ANDA ANDA040649 REMEDYREPACK INC. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-647_dc31da8c-da6d-4bd4-926f-7f53efa48716 52125-647 HUMAN PRESCRIPTION DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL 20131202 ANDA ANDA040649 REMEDYREPACK INC. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-648_e6349032-e394-456f-abce-b34b97a3a85d 52125-648 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130624 ANDA ANDA040907 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 52125-649_eb6efe58-2bfe-4da4-b165-ee8ca2370a01 52125-649 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20130624 ANDA ANDA090622 REMEDYREPACK INC. BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] 52125-650_a513e8d1-dfa0-42c4-8a78-3c61a773e901 52125-650 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20130624 NDA NDA020064 REMEDYREPACK INC. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 52125-651_d5d7110b-be6b-4a17-bc58-5caadaacdf3a 52125-651 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride CAPSULE ORAL 20130701 ANDA ANDA040319 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52125-652_7b9f409b-ee73-4817-a57b-eee50d0db9a3 52125-652 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20130701 ANDA ANDA070184 REMEDYREPACK INC. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 52125-653_a05afe18-7268-4039-b6e5-53ac51fef64b 52125-653 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20130701 ANDA ANDA076341 REMEDYREPACK INC. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52125-654_3aeca8b4-e668-4946-b90c-1498d57d3c1b 52125-654 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20130712 ANDA ANDA089644 REMEDYREPACK INC. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 10 ug/mL; mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-654_8a1f4f8e-c152-4e61-9f99-07d55ba23936 52125-654 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20131121 ANDA ANDA089644 REMEDYREPACK INC. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 10 ug/mL; mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-654_f494ae6d-f93c-456e-8d22-ba23a7d648e5 52125-654 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20131121 ANDA ANDA089644 REMEDYREPACK INC. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 10 ug/mL; mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-656_8371f669-3ea3-4bc1-849b-f441bdce30f9 52125-656 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION OPHTHALMIC 20130701 ANDA ANDA076231 REMEDYREPACK INC. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-656_90f35830-f744-40d8-83a8-6da20e10d7ba 52125-656 HUMAN PRESCRIPTION DRUG Ofloxacin ofloxacin SOLUTION AURICULAR (OTIC) 20131125 ANDA ANDA078222 REMEDYREPACK INC. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-658_5520810f-f575-49ab-8f74-9ee3ee3c230f 52125-658 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20130701 ANDA ANDA075805 REMEDYREPACK INC. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 52125-659_c401da97-b6eb-4aa4-8f28-dad321f15665 52125-659 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20130703 ANDA ANDA040734 REMEDYREPACK INC. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 52125-660_928f4c6d-b788-4518-8717-604bcbac05b4 52125-660 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20130703 ANDA ANDA070325 REMEDYREPACK INC. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 52125-661_5c514597-1afc-4579-a152-9d6275ad7750 52125-661 HUMAN PRESCRIPTION DRUG Bacteriostatic Water WATER INJECTION, SOLUTION INTRAMUSCULAR 20130703 NDA NDA018802 REMEDYREPACK INC. WATER 1 mL/mL 52125-663_c854c35e-6d05-4a7e-a9dc-e6a414524ed5 52125-663 HUMAN PRESCRIPTION DRUG Phisohex hexachlorophene EMULSION TOPICAL 20130705 NDA NDA006882 REMEDYREPACK INC. HEXACHLOROPHENE 30 mg/mL Antiseptic [EPC] 52125-665_274e55d6-8d20-408a-a68e-90d7421ba7df 52125-665 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130709 ANDA ANDA202176 REMEDYREPACK INC. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 52125-666_345e1180-d06b-4ced-a215-ef95f214939c 52125-666 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride TABLET ORAL 20130709 ANDA ANDA040317 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52125-666_af317f98-2a4f-42ba-917e-6d29789edc5f 52125-666 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride TABLET ORAL 20130716 ANDA ANDA040317 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52125-667_ade51e11-8f7d-4093-8a8b-d954308032f7 52125-667 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20130709 ANDA ANDA074201 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-668_1cbde3c6-a0ab-4c2b-9892-fa1816f608e3 52125-668 HUMAN PRESCRIPTION DRUG Adenosine adenosine INJECTION, SOLUTION INTRAVENOUS 20130924 ANDA ANDA078076 REMEDYREPACK INC. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 52125-668_284fe94c-ef02-49c3-b529-f6f98e1659ad 52125-668 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20141003 ANDA ANDA078076 REMEDYREPACK INC. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 52125-668_6fa12f87-bbce-48d0-92a3-87815c5fd217 52125-668 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20140317 ANDA ANDA078076 REMEDYREPACK INC. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 52125-668_c6267b41-71b9-4129-963a-22a09598f178 52125-668 HUMAN PRESCRIPTION DRUG Adenosine adenosine INJECTION, SOLUTION INTRAVENOUS 20130716 ANDA ANDA078076 REMEDYREPACK INC. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 52125-669_4241b7ad-4ac7-4cfb-99ee-29e959085dda 52125-669 HUMAN PRESCRIPTION DRUG Omnaris ciclesonide SPRAY NASAL 20130716 NDA NDA022004 REMEDYREPACK INC. CICLESONIDE 50 ug/1 52125-671_2a0647f3-c479-490b-b87b-14787a3536ca 52125-671 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20130716 ANDA ANDA083158 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-671_35c9a48f-2e35-4ef6-88e7-38a8ee8b64f9 52125-671 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 20130924 ANDA ANDA088299 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-672_0ee2accb-f181-4e0e-a424-eaa9306f7191 52125-672 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SPRAY NASAL 20140109 ANDA ANDA076598 REMEDYREPACK INC. IPRATROPIUM BROMIDE ANHYDROUS 42 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52125-672_7bdcff64-d31d-40f6-9207-185de605ca09 52125-672 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SPRAY NASAL 20130716 ANDA ANDA076598 REMEDYREPACK INC. IPRATROPIUM BROMIDE ANHYDROUS 42 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52125-673_201e8ed0-70b2-4c70-9e8b-0df9ab365329 52125-673 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20130725 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-673_5ac52213-46ee-4354-bd24-5c9998b08fd4 52125-673 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20130821 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-673_e43e1375-bcea-4bc1-95a7-4c05022d2976 52125-673 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20130716 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-673_fde2a31b-dcab-41cf-973a-103f70a8afb1 52125-673 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20130725 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-674_1078d199-296d-49d3-9f82-527abcb8ceda 52125-674 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130716 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-674_ce10d225-729b-43e7-9b1d-f83fff45bac6 52125-674 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130716 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-674_cec7db07-7234-4f6a-b9fb-7c30617d1a7a 52125-674 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130828 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-674_e9a03d16-af7b-44e4-baf5-49ac2512d11e 52125-674 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130731 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-676_6471532e-d7dd-4b44-a6c2-167e763fc7ce 52125-676 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20130725 ANDA ANDA090493 REMEDYREPACK INC. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 52125-677_0fbaef00-5112-4052-aa7b-81a6a6891e56 52125-677 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130725 ANDA ANDA090931 REMEDYREPACK INC. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-678_63711bcb-5148-4cc9-9f37-4736fe346fa5 52125-678 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20130725 ANDA ANDA090622 REMEDYREPACK INC. BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] 52125-679_4829c300-4f11-49c4-8dd9-699877456310 52125-679 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130731 ANDA ANDA090548 REMEDYREPACK INC. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52125-680_29e50144-03e0-4889-a4aa-6e74a137579c 52125-680 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20131105 ANDA ANDA065169 REMEDYREPACK INC. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52125-680_2cd83b9f-72fd-4497-9cab-d3be3a1e44aa 52125-680 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20131217 ANDA ANDA065169 REMEDYREPACK INC. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52125-680_e36bd326-1814-4ddd-8f6f-9230200cd8d2 52125-680 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130821 ANDA ANDA065169 REMEDYREPACK INC. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52125-681_29644d9a-f5a9-411b-9ef5-8902bc2bf8db 52125-681 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20130821 ANDA ANDA077921 REMEDYREPACK INC. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-682_6a24ad00-2169-41f0-bb7d-915d4c383666 52125-682 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20130827 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-683_507b5c7f-3a6e-4244-8df2-d5e1599ab9cc 52125-683 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20130827 ANDA ANDA040756 REMEDYREPACK INC. FOLIC ACID 1 mg/1 52125-684_27941fe1-dbd3-4b62-8ec1-d806aaece8b1 52125-684 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20140130 ANDA ANDA090624 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 52125-684_60eae350-4804-429c-977e-31ad0fbfadee 52125-684 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20130827 ANDA ANDA090624 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 52125-684_82a0ca0e-7d1e-4da3-966b-c6e585b89714 52125-684 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20131003 ANDA ANDA090624 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 52125-684_a2f325f5-4877-42f8-929f-4a561e947a9e 52125-684 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20130827 ANDA ANDA090624 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 52125-684_f9c567d0-225a-4145-8e8c-027587c5f06b 52125-684 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20140423 ANDA ANDA090624 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 52125-685_0ca1db9f-f698-451c-8008-ffcfb0cf6e61 52125-685 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20130827 ANDA ANDA040684 REMEDYREPACK INC. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-686_8ced1c6d-fdb3-4c48-8dc7-35defde4029d 52125-686 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20140226 ANDA ANDA077901 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 52125-686_fab96823-92c7-403b-b4d1-b8b4e86ebcea 52125-686 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20130828 ANDA ANDA077901 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 52125-688_7a1806ce-8958-47e9-bdec-ba619db92c2c 52125-688 HUMAN PRESCRIPTION DRUG SSD Cream Silver Sulfadiazine CREAM TOPICAL 20131202 NDA NDA018578 REMEDYREPACK INC. SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 52125-688_a7c167a4-9aac-4f4e-a73a-7c5c2e61742d 52125-688 HUMAN PRESCRIPTION DRUG SSD Cream Silver Sulfadiazine CREAM TOPICAL 20130827 NDA NDA018578 REMEDYREPACK INC. SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 52125-690_7986a712-4830-4f13-afe4-736b8b737776 52125-690 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130904 ANDA ANDA076765 REMEDYREPACK INC. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-691_3c30efaf-e02f-404e-ae3e-f703c2258034 52125-691 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130905 ANDA ANDA076765 REMEDYREPACK INC. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-694_05f8c157-e8bf-41c7-8c3c-9d24a0c65cc8 52125-694 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20130926 ANDA ANDA089586 REMEDYREPACK INC. FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-695_0484985b-3daa-4740-8839-f5502a6f6ac3 52125-695 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130904 ANDA ANDA040148 REMEDYREPACK INC. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 52125-696_704dd3fc-f7fa-42e8-beb7-00c2bd1d573c 52125-696 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20130904 ANDA ANDA077336 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-698_2a200d51-86ec-4019-9381-2efecb05d0eb 52125-698 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20130919 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-698_6a912681-b894-48c1-9271-c254e3ce8ed3 52125-698 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20131101 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-699_ed655ebb-36f7-4a03-b2af-f386276c1c13 52125-699 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 20130924 NDA AUTHORIZED GENERIC NDA050711 REMEDYREPACK INC. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-700_3a0f2363-61f2-4e78-8ade-a6b394143aa3 52125-700 HUMAN PRESCRIPTION DRUG Zithromax AZITHROMYCIN DIHYDRATE TABLET, FILM COATED ORAL 20130919 NDA NDA050784 REMEDYREPACK INC. AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-701_507089a9-9072-482d-b569-8687ddc7df80 52125-701 HUMAN PRESCRIPTION DRUG Trimethoprim trimethoprim TABLET ORAL 20130924 ANDA ANDA091437 REMEDYREPACK INC. TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 52125-702_0ad6f5ab-619f-4212-a74a-8be0ac913b74 52125-702 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20130919 ANDA ANDA075498 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-702_648b4acc-88a5-409d-90c5-dfaede2c8a80 52125-702 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20130919 ANDA ANDA075498 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-703_02c6bba3-b6cd-4c64-9182-457e281d338a 52125-703 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20141028 ANDA ANDA091179 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-703_9eaad499-9609-4f03-a1e5-ed17d73fbc16 52125-703 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20131231 ANDA ANDA091179 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-703_a2558a5e-f12a-49ce-98a3-f9eb90fced24 52125-703 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20141124 ANDA ANDA091179 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-703_d84ea15a-938b-4e8e-99e8-95e79caf3613 52125-703 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20130919 ANDA ANDA091179 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-704_1ed04551-7e2b-430c-a5af-468f3dc88a35 52125-704 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131231 ANDA ANDA076710 REMEDYREPACK INC. LEVOFLOXACIN 250 mg/1 52125-705_6807357e-11d3-44fc-b2d9-3f723e493d35 52125-705 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20130919 ANDA ANDA075498 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-706_446861dd-679f-4129-9619-681acdde3648 52125-706 HUMAN PRESCRIPTION DRUG Oxybutynin ChlorideExtended Release Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20130919 ANDA ANDA078503 REMEDYREPACK INC. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52125-707_8b0b307c-904c-4bfe-b719-a4a79209dd39 52125-707 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20130919 ANDA ANDA091256 REMEDYREPACK INC. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 52125-707_9bc50c56-e656-4182-81bd-d289b96c0902 52125-707 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20131007 ANDA ANDA091256 REMEDYREPACK INC. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 52125-708_cc99c885-cb4d-42c4-a047-a780541156eb 52125-708 HUMAN PRESCRIPTION DRUG Nystatin nystatin CREAM TOPICAL 20130919 ANDA ANDA065315 REMEDYREPACK INC. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 52125-709_825aeb79-97cf-4faf-953a-800755ad14e7 52125-709 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET ORAL 20130919 ANDA ANDA078917 REMEDYREPACK INC. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 52125-710_59d2f16c-43b1-4c3a-8d1b-820e23a6e20f 52125-710 HUMAN PRESCRIPTION DRUG sildenafil sildenafil TABLET, FILM COATED ORAL 20130919 ANDA ANDA202598 REMEDYREPACK INC. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 52125-710_995e47d3-3028-40f7-8778-a908c82e0512 52125-710 HUMAN PRESCRIPTION DRUG sildenafil sildenafil TABLET, FILM COATED ORAL 20130919 ANDA ANDA202598 REMEDYREPACK INC. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 52125-711_e09892a6-2b13-4691-86fc-b59979d7508d 52125-711 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20131009 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-711_f90b2437-fe31-446d-93fe-131a5bbfc96b 52125-711 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20130924 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-712_7796434b-3106-436b-ad0e-6cbbbc0c2958 52125-712 HUMAN PRESCRIPTION DRUG KENALOG-40 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRAMUSCULAR 20130924 NDA NDA014901 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 40 mg/mL 52125-712_a3c4231a-024c-4be7-ae9c-95e5987ba861 52125-712 HUMAN PRESCRIPTION DRUG KENALOG-40 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRAMUSCULAR 20140415 NDA NDA014901 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 40 mg/mL 52125-714_33fed08d-f486-441e-8118-a4c6283bf06d 52125-714 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION TOPICAL 20130925 ANDA ANDA040710 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-714_3fed439f-d001-4623-8aea-789734f14931 52125-714 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION TOPICAL 20130925 ANDA ANDA040710 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-715_925bf372-fe3c-468a-9032-aef991accc4c 52125-715 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20130926 ANDA ANDA201190 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 52125-716_64f9f7e9-e9f0-4bba-b308-260425bd68e8 52125-716 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20130926 ANDA ANDA091276 REMEDYREPACK INC. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-717_5015cdc4-d188-4215-8f32-26c648049c5a 52125-717 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20130926 ANDA ANDA065442 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 52125-717_aa35c6e2-c556-4f69-b819-95f9b6227e79 52125-717 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140710 ANDA ANDA065442 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 52125-718_c7b61261-ec2f-4bb9-adec-9a8c997ac9e3 52125-718 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130926 ANDA ANDA075828 REMEDYREPACK INC. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52125-719_6e7f2fcf-8960-4562-b572-3b79983a6f03 52125-719 HUMAN PRESCRIPTION DRUG Ranitidine 75 Ranitidine TABLET ORAL 20130926 ANDA ANDA076760 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 75 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 52125-720_f674b418-c908-4aed-a7fa-48f364fb0a41 52125-720 HUMAN PRESCRIPTION DRUG Silver Sulfadiazene Silver Sulfadiazine CREAM TOPICAL 20130926 NDA NDA018578 REMEDYREPACK INC. SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 52125-721_3f63bc40-43de-4c10-ae3c-86c5bb086939 52125-721 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20131121 ANDA ANDA089646 REMEDYREPACK INC. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 20 ug/mL; mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-721_c1047e34-e2c1-4ca0-9411-f94c4de14b38 52125-721 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20131004 ANDA ANDA089646 REMEDYREPACK INC. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 20 ug/mL; mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-722_79c46d66-1927-4337-834c-d193d6e657a7 52125-722 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20131007 ANDA ANDA071017 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 52125-724_2eb06a24-c9c5-4fe2-8344-332500bdde77 52125-724 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20131004 NDA NDA021286 REMEDYREPACK INC. OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-725_9645c182-d476-4058-9b3e-7d9996c68648 52125-725 HUMAN PRESCRIPTION DRUG TOPROLXL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20131004 NDA NDA019962 REMEDYREPACK INC. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-726_de1ca6af-55f5-45af-8bb8-ab2ee6ccaf67 52125-726 HUMAN PRESCRIPTION DRUG TOPROLXL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20131004 NDA NDA019962 REMEDYREPACK INC. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-727_00e33865-086b-4b10-8e59-3accc7e812ae 52125-727 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 20131007 ANDA ANDA091205 REMEDYREPACK INC. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] 52125-728_bafa9891-f2f0-468f-9a09-df839b3f10a7 52125-728 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20131003 ANDA ANDA075795 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-729_87a5fd3e-86bd-4f0f-bc58-a73cb9be8285 52125-729 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20131004 ANDA ANDA040821 REMEDYREPACK INC. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52125-730_77fad8a3-f95b-4451-a616-8c6c8b1a67cb 52125-730 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20131004 NDA NDA021445 REMEDYREPACK INC. EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] 52125-731_2428656d-62d0-4d7b-a522-14a0008b7a5e 52125-731 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20131004 ANDA ANDA040653 REMEDYREPACK INC. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52125-732_96c298b7-a996-4d19-820a-631468a6db2d 52125-732 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20131007 ANDA ANDA075710 REMEDYREPACK INC. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 52125-734_3cc31f02-c6b8-43c4-a86f-cd1e7136fa9e 52125-734 HUMAN PRESCRIPTION DRUG CAFFEINE CITRATE CAFFEINE CITRATE SOLUTION ORAL 20131031 ANDA ANDA090357 REMEDYREPACK INC. CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 52125-734_da7a82c3-da17-453c-b9a0-3387db086bae 52125-734 HUMAN PRESCRIPTION DRUG CAFFEINE CITRATE CAFFEINE CITRATE SOLUTION ORAL 20131004 ANDA ANDA090357 REMEDYREPACK INC. CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 52125-737_da82e0f8-7dd0-46d6-9014-423833bdd406 52125-737 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20131007 ANDA ANDA090548 REMEDYREPACK INC. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52125-738_0dd44e85-03ec-45be-ab3d-878533420f6f 52125-738 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20131004 ANDA ANDA075710 REMEDYREPACK INC. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 52125-739_34512440-e43b-41cb-ab0e-f0da6d859f2f 52125-739 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC) 20131004 ANDA ANDA076128 REMEDYREPACK INC. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-739_3e72e147-5090-48b5-a246-540952beb7b5 52125-739 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC) 20131125 ANDA ANDA076128 REMEDYREPACK INC. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-740_b07385f0-ecea-4a45-8218-1090cd3a2237 52125-740 HUMAN PRESCRIPTION DRUG BiDil Hydralazine hydrochloride and Isosorbide dinitrate TABLET, FILM COATED ORAL 20131008 NDA NDA020727 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE 37.5; 20 mg/1; mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 52125-742_e642a741-eb06-435f-b38d-38c591c81e31 52125-742 HUMAN PRESCRIPTION DRUG ULORIC febuxostat TABLET ORAL 20131008 NDA NDA021856 REMEDYREPACK INC. FEBUXOSTAT 40 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 52125-743_3fc81ced-e377-4ee6-910e-2c8f87339ae7 52125-743 HUMAN PRESCRIPTION DRUG Levocarnitine Levocarnitine SOLUTION ORAL 20131008 ANDA ANDA076851 REMEDYREPACK INC. LEVOCARNITINE 1 g/10mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] 52125-743_6b60330d-1b33-4ba7-999e-0df546af088f 52125-743 HUMAN PRESCRIPTION DRUG Levocarnitine Levocarnitine SOLUTION ORAL 20131129 ANDA ANDA076851 REMEDYREPACK INC. LEVOCARNITINE 1 g/10mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] 52125-744_4012a47f-e73f-48a4-89c1-c9ea85b0a0da 52125-744 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION, SOLUTION INTRAMUSCULAR 20131217 ANDA ANDA077551 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-744_509be45f-5418-4a25-a4f2-2acdb02bbba3 52125-744 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION, SOLUTION INTRAMUSCULAR 20131125 ANDA ANDA077551 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-744_5e29555f-b58f-4fb5-964a-8f7ca54cf4cc 52125-744 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION, SOLUTION INTRAMUSCULAR 20131014 ANDA ANDA077551 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-744_f87f74ca-6fd2-4f18-8e92-d96b38177c0b 52125-744 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION, SOLUTION INTRAMUSCULAR 20131125 ANDA ANDA077551 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-745_517a536b-3f83-461b-8876-b98c65ce295e 52125-745 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride CAPSULE ORAL 20131015 ANDA ANDA040319 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52125-746_aa534db7-15b6-4fbd-9972-080ecf216309 52125-746 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 20131015 ANDA ANDA064065 REMEDYREPACK INC. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 52125-747_77d3ade9-6251-438b-867a-b3b7531db37b 52125-747 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20140514 ANDA ANDA089644 REMEDYREPACK INC. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 10 ug/mL; mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-747_c79bc453-7cbb-4fb0-bf06-badfaacf80d9 52125-747 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20131031 ANDA ANDA089644 REMEDYREPACK INC. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 10 ug/mL; mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-747_fc5c9da1-c966-4494-87ec-80f1c35779b5 52125-747 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20140514 ANDA ANDA089644 REMEDYREPACK INC. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 10 ug/mL; mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-748_3ed646c6-3fb9-4e89-ade1-d8304ba6c4fe 52125-748 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20131015 ANDA ANDA065507 REMEDYREPACK INC. AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-748_77f7fbd5-6501-43c6-8204-420889ba4dac 52125-748 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20140213 ANDA ANDA065507 REMEDYREPACK INC. AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-748_b6875d7f-6462-4c84-a8ac-529bbf7c0a7d 52125-748 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20140507 ANDA ANDA065507 REMEDYREPACK INC. AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-749_74ed5abc-8e51-4f22-8ef5-cda31bced275 52125-749 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20131217 ANDA ANDA065391 REMEDYREPACK INC. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52125-749_d8fd7d0a-f18a-480e-9f85-d5017a65aa71 52125-749 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20131015 ANDA ANDA065391 REMEDYREPACK INC. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52125-750_641c39ff-79c5-4b48-9b11-8098b048d533 52125-750 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20131015 ANDA ANDA085970 REMEDYREPACK INC. AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 52125-751_733af5dc-a915-4a23-bb22-57f3cf8abe31 52125-751 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20131030 ANDA ANDA065404 REMEDYREPACK INC. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-755_06f1219c-88ff-4508-a60a-f7a605542d7b 52125-755 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20131101 NDA NDA021342 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-756_98885ca4-2538-445d-af27-a8255493f24a 52125-756 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20131029 ANDA ANDA075113 REMEDYREPACK INC. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-757_1656ef9f-dbf9-4d0e-b576-ec07dc476928 52125-757 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20131031 ANDA ANDA078406 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-758_4fe55a05-7c66-49a8-b35f-b1642b540724 52125-758 HUMAN PRESCRIPTION DRUG Adenoscan adenosine SOLUTION INTRAVENOUS 20130610 NDA NDA020059 REMEDYREPACK INC. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 52125-759_1a6e75b3-a555-4bc6-b8a7-6db5a0718ed8 52125-759 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20131121 ANDA ANDA088327 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-759_a5b0a0d1-1d4f-41fb-9441-11a6488c1d6b 52125-759 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20131101 ANDA ANDA088327 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-759_ab1fa51f-f9fc-4e1c-99df-d9b3204a9c45 52125-759 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20131101 ANDA ANDA088327 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-760_26e82fea-a6f6-4316-84b7-29b371fae40c 52125-760 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20131105 ANDA ANDA077987 REMEDYREPACK INC. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52125-761_3f0e103f-5081-4f81-99b9-5755b20adfd9 52125-761 HUMAN PRESCRIPTION DRUG Glipizide and Metformin HCl Glipizide and Metformin HCl TABLET, FILM COATED ORAL 20140218 ANDA ANDA078728 REMEDYREPACK INC. GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-762_93996be1-7b30-4f1b-8972-cd526af3ed4a 52125-762 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20131112 ANDA ANDA091519 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-763_4b860797-ee13-4703-8857-144a19061402 52125-763 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20131112 ANDA ANDA091519 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-764_2b525eda-9f7a-40c7-9133-a1cb3785b877 52125-764 HUMAN PRESCRIPTION DRUG GlipizideER ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131112 ANDA ANDA076467 REMEDYREPACK INC. GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-765_674adfa9-2493-4fcf-955b-a68aabb9b87e 52125-765 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20131112 ANDA ANDA077270 REMEDYREPACK INC. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-766_aff816f3-7bff-4dd1-a68a-578ece063780 52125-766 HUMAN PRESCRIPTION DRUG Glipizide and Metformin HCl Glipizide and Metformin HCl TABLET, FILM COATED ORAL 20131119 ANDA ANDA078728 REMEDYREPACK INC. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 52125-767_728de292-2c56-4f33-a456-b34391b1d122 52125-767 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20131112 ANDA ANDA077091 REMEDYREPACK INC. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-768_b6a01325-4854-4976-99c9-7c3dbd747a68 52125-768 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20131112 ANDA ANDA078466 REMEDYREPACK INC. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 52125-769_b57c24fe-2e39-4d6e-8b8e-73a9cc704ed2 52125-769 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20131112 ANDA ANDA078466 REMEDYREPACK INC. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 52125-770_dbbd60c1-af0d-457e-af22-51752b220e1c 52125-770 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril maleate and hydrochlorothiazide TABLET ORAL 20131112 ANDA ANDA076486 REMEDYREPACK INC. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 5; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 52125-771_aa42cdb0-87a6-4264-8f19-aa79209c8bdd 52125-771 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20131112 ANDA ANDA040226 REMEDYREPACK INC. PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-772_dfa1042b-5dbf-4069-b94b-7c9f58774e2f 52125-772 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20140218 ANDA ANDA078466 REMEDYREPACK INC. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 52125-773_24af3bc9-9aca-41de-87c5-155abdfb0b02 52125-773 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20131112 NDA AUTHORIZED GENERIC NDA018238 REMEDYREPACK INC. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 52125-774_49c49b79-a384-45e6-ac3c-c73d2b01aeec 52125-774 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20131217 ANDA ANDA065230 REMEDYREPACK INC. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52125-774_fd54ea0d-eb58-45d6-8ca0-cf37f2be3fd4 52125-774 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20131217 ANDA ANDA065230 REMEDYREPACK INC. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52125-775_2aa718fd-4611-4b4d-92ed-9096c22cbd7a 52125-775 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140414 ANDA ANDA085161 REMEDYREPACK INC. PREDNISONE 20 mg/1 52125-775_2faa8c12-2f8c-4986-85cd-1f4d4a55d7e6 52125-775 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20131202 ANDA ANDA085161 REMEDYREPACK INC. PREDNISONE 20 mg/1 52125-775_6dcf31ed-c391-4f3a-904d-a1fb4ddb6b04 52125-775 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20131202 ANDA ANDA085161 REMEDYREPACK INC. PREDNISONE 20 mg/1 52125-775_eb1a62be-08fd-4697-a68e-83ca92c7e3b1 52125-775 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140917 ANDA ANDA085161 REMEDYREPACK INC. PREDNISONE 20 mg/1 52125-775_ec504926-039b-4a16-b90e-6fc7db2aa674 52125-775 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20131112 ANDA ANDA085161 REMEDYREPACK INC. PREDNISONE 20 mg/1 52125-775_ee619bda-20a4-4f6c-a217-96b6990e3f52 52125-775 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20131205 ANDA ANDA085161 REMEDYREPACK INC. PREDNISONE 20 mg/1 52125-776_b317c5d9-3057-4e0a-8253-aeb0c05d94a4 52125-776 HUMAN PRESCRIPTION DRUG Diltiazem HydrochlorideExtended Release Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20131118 ANDA ANDA074984 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52125-777_5c020895-c326-4d6b-85a3-2c401270c725 52125-777 HUMAN PRESCRIPTION DRUG Dextromethorphan Hydrobromide and Promethazine Hydrochloride Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL 20131202 ANDA ANDA088864 REMEDYREPACK INC. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-777_ae028767-8617-4d8d-8a0e-f06605f602ab 52125-777 HUMAN PRESCRIPTION DRUG Dextromethorphan Hydrobromide and Promethazine Hydrochloride Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL 20131213 ANDA ANDA088864 REMEDYREPACK INC. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-778_434e0dda-c4e0-433b-b930-fc680ffd63fa 52125-778 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 20131217 ANDA ANDA085027 REMEDYREPACK INC. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52125-779_a3843174-7da3-4dd5-910d-40af09982005 52125-779 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20131122 ANDA ANDA040734 REMEDYREPACK INC. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 52125-780_4738da16-1486-495c-8759-d87053c04fc9 52125-780 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20131231 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-780_6df8e582-95f3-479b-99c9-a6994e7ea57c 52125-780 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20131120 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-780_6f2e6ffc-baa5-4c4b-ad92-a312f537917f 52125-780 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20131120 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-780_a8f6c2b6-8dd2-4951-b8b6-ac8fce09ed29 52125-780 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20131120 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-780_bc70d745-9c9a-401d-ac4f-70af386f81f1 52125-780 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20131120 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-781_01053157-9bbc-4124-b946-838543f1227f 52125-781 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20131122 ANDA ANDA070044 REMEDYREPACK INC. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 52125-781_1fa5c825-6db0-4f40-a460-ff8585fd6946 52125-781 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20131122 ANDA ANDA070044 REMEDYREPACK INC. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 52125-783_8ec4142f-7f61-4b34-92c5-f8a15fe7b306 52125-783 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20131118 ANDA ANDA065055 REMEDYREPACK INC. DOXYCYCLINE 100 mg/1 52125-784_fb2f66d6-378b-460f-b1d4-3669777a6e8b 52125-784 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20131118 ANDA ANDA077995 REMEDYREPACK INC. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-787_2a28d155-6b08-459f-a7db-33d4776f1777 52125-787 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20131204 ANDA ANDA065509 REMEDYREPACK INC. AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-787_2bb00266-94d8-4294-87bf-8d8c1df844eb 52125-787 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20131204 ANDA ANDA065509 REMEDYREPACK INC. AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-789_8889771c-1c19-4b5a-b993-c28eb7593320 52125-789 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC 20131217 ANDA ANDA076673 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-791_0f81e661-5fa0-46b7-865a-b9d1a3c92195 52125-791 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20131205 ANDA ANDA078925 REMEDYREPACK INC. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-792_9ad78df9-db41-4acf-beb2-c83223ae9f83 52125-792 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20131205 ANDA ANDA076847 REMEDYREPACK INC. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 52125-793_c8f7c3e0-3191-46b7-8ecf-aadeb3004139 52125-793 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20131205 ANDA ANDA078406 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-794_d82cc688-6971-44cd-80d0-79274b881882 52125-794 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20131205 ANDA ANDA074201 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-795_887f9b55-6a9a-46da-97a6-47da8def650b 52125-795 HUMAN PRESCRIPTION DRUG BACTROBAN mupirocin calcium CREAM TOPICAL 20131213 NDA NDA050746 REMEDYREPACK INC. MUPIROCIN CALCIUM 21.5 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 52125-795_aaaba26f-e8b8-4c38-baa0-ddc20c97c4cf 52125-795 HUMAN PRESCRIPTION DRUG BACTROBAN mupirocin calcium CREAM TOPICAL 20131204 NDA NDA050746 REMEDYREPACK INC. MUPIROCIN CALCIUM 21.5 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 52125-796_36fda65c-1941-4e31-a43a-a8a1e168adca 52125-796 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20131231 ANDA ANDA040644 REMEDYREPACK INC. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 52125-797_26b5a0ea-2c33-4fbc-b6bb-cffb33b8163f 52125-797 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20131231 ANDA ANDA074569 REMEDYREPACK INC. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 52125-799_6dd2913f-4247-41c3-a7ba-94855b6e924a 52125-799 HUMAN PRESCRIPTION DRUG Hydroxocobalamin Hydroxocobalamin INJECTION, SOLUTION INTRAMUSCULAR 20131231 ANDA ANDA085998 REMEDYREPACK INC. HYDROXOCOBALAMIN ACETATE 1000 ug/mL Antidote [EPC] 52125-799_f8c8de1b-9125-4d1c-8dc0-e266ace90190 52125-799 HUMAN PRESCRIPTION DRUG Hydroxocobalamin Hydroxocobalamin INJECTION, SOLUTION INTRAMUSCULAR 20131231 ANDA ANDA085998 REMEDYREPACK INC. HYDROXOCOBALAMIN ACETATE 1000 ug/mL Antidote [EPC] 52125-800_7ffbe81e-c4e8-405e-bf78-b354f39dad00 52125-800 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 20131231 ANDA ANDA064030 REMEDYREPACK INC. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-801_dbe6d1ce-ed98-46b7-8082-cb960e0c3b18 52125-801 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20131231 ANDA ANDA078925 REMEDYREPACK INC. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-802_487b3049-3bdf-4e46-80db-29f1511ebe7a 52125-802 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20131231 ANDA ANDA078069 REMEDYREPACK INC. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-803_961b5dc6-7684-434e-809f-9807ed8f69e8 52125-803 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 20140109 ANDA ANDA040159 REMEDYREPACK INC. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 52125-804_ddf04a8e-2bbb-4926-bfc2-731d3afac7fd 52125-804 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20140514 ANDA ANDA076622 REMEDYREPACK INC. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-805_d37fbbc1-fe2a-490b-b01a-ead151f3e972 52125-805 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride trimethobenzamide hydrochloride INJECTION INTRAMUSCULAR 20140109 NDA AUTHORIZED GENERIC NDA017530 REMEDYREPACK INC. TRIMETHOBENZAMIDE HYDROCHLORIDE 100 mg/mL Antiemetic [EPC],Emesis Suppression [PE] 52125-807_fc58d0dd-d799-4b10-bf03-74b4d904c7c4 52125-807 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140109 ANDA ANDA200503 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 52125-808_d5094044-7ee9-44c0-a72b-b4d404c07814 52125-808 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20140109 ANDA ANDA200651 REMEDYREPACK INC. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-809_c9dbd901-4704-43e2-ac52-8f6c85c92621 52125-809 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION, SOLUTION INTRAVENOUS 20140109 ANDA ANDA076759 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-810_be848354-36c1-4724-b078-1ae8a93398ed 52125-810 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20140219 ANDA ANDA078554 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-811_f3b89d82-35b2-4982-a206-361e5f4cc408 52125-811 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20140109 ANDA ANDA076187 REMEDYREPACK INC. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-812_b6b463b1-5e0d-4d9b-a48d-de67751c1587 52125-812 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140121 ANDA ANDA090798 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 52125-813_014cffef-2735-4769-922c-196c79c43886 52125-813 HUMAN PRESCRIPTION DRUG VENTOLINHFA HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20140130 NDA NDA020983 REMEDYREPACK INC. ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 52125-813_eeb4c4e6-f574-4f98-a746-0be35bed3a5d 52125-813 HUMAN PRESCRIPTION DRUG VENTOLINHFA HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20141008 NDA NDA020983 REMEDYREPACK INC. ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 52125-814_08b311ff-b158-4108-9d0a-2a9eb6880bfb 52125-814 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140130 ANDA ANDA078866 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 52125-816_36fca15b-d0df-4213-a2be-811d74714d49 52125-816 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20140130 ANDA ANDA202764 REMEDYREPACK INC. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-817_c4a5b394-4f8e-470e-8672-a7246b87ec79 52125-817 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140130 ANDA ANDA090745 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-818_5ceb15dc-c2c3-4045-8e5e-0a19140218ad 52125-818 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140130 ANDA ANDA090745 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-819_d9bed11d-81d0-4319-860e-28d1a2079ee1 52125-819 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20140203 ANDA ANDA075580 REMEDYREPACK INC. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-820_01061bcb-117d-4014-a941-bc859962d178 52125-820 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 20140130 ANDA ANDA074434 REMEDYREPACK INC. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-822_1e906b1f-9624-4b8a-a1c7-c981616f5313 52125-822 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20140130 ANDA ANDA040804 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 52125-823_e5881883-bcc4-4106-8804-3fb85b975140 52125-823 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20140130 ANDA ANDA078556 REMEDYREPACK INC. DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 52125-824_334e4598-af5e-4368-af95-9ecafc2aa499 52125-824 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20140203 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52125-825_f1c22290-d8ae-47f8-8560-a07fc0627e52 52125-825 HUMAN PRESCRIPTION DRUG WELLBUTRIN bupropion hydrochloride TABLET, FILM COATED ORAL 20140130 NDA NDA018644 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 52125-826_f4e07986-dc17-4bd0-9b3c-33be6635f247 52125-826 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20140203 ANDA ANDA091038 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 52125-827_f14ff368-f400-4e6f-9015-b46801638eaf 52125-827 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20140203 ANDA ANDA074260 REMEDYREPACK INC. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 52125-828_dcd66d70-5211-43e0-80be-44474bec2ef5 52125-828 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20140206 ANDA ANDA073144 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 52125-829_4b1868c9-885c-43ad-8ef7-ab972233c315 52125-829 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20140206 ANDA ANDA091038 REMEDYREPACK INC. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 52125-830_af9d9f6e-7dff-4124-a873-6bb09c05d892 52125-830 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20140218 ANDA ANDA089646 REMEDYREPACK INC. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 20 ug/mL; mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52125-832_68d10b1e-b1f3-4bc0-b356-467a723ec0a6 52125-832 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR 20140218 ANDA ANDA083312 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-832_f7d40cd7-458d-48c0-bf99-991f31308024 52125-832 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR 20140611 ANDA ANDA083312 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52125-833_7df773ee-514e-4b02-a4a2-a97f649ee9e0 52125-833 VACCINE GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant INJECTION, SUSPENSION INTRAMUSCULAR 20140213 BLA BLA125126 REMEDYREPACK INC. HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN 40; 40; 20; 20 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 52125-834_bc2b8c56-191b-4ca5-8895-b0099255fa14 52125-834 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20140213 ANDA ANDA202600 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-835_60a4f0c8-968d-4cef-917b-b4dd9a436a40 52125-835 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20140220 ANDA ANDA077032 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-837_ef360fc7-37a1-4a48-9181-835d33699027 52125-837 VACCINE RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR 20140220 BLA BLA101066 REMEDYREPACK INC. HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 10 ug/mL Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 52125-838_b0dbc49d-6664-4a20-9d03-cbfea1adba19 52125-838 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140220 ANDA ANDA202038 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 52125-839_44016a1b-ef1b-4fc8-9aa9-88d71001731a 52125-839 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140218 ANDA ANDA078281 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 52125-840_cc435e59-e0d5-4a21-85b2-89395bb80da4 52125-840 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140218 ANDA ANDA090705 REMEDYREPACK INC. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-841_a2770e04-4f86-486f-8bfc-c038f630ee0a 52125-841 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140220 ANDA ANDA075828 REMEDYREPACK INC. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52125-842_03759428-81b4-4172-b501-4ef25770621f 52125-842 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140220 ANDA ANDA065169 REMEDYREPACK INC. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52125-844_9b0502f4-21e8-44fc-9249-4ed156d31157 52125-844 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20140220 ANDA ANDA065405 REMEDYREPACK INC. AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-844_bf7eb407-4aa0-4b26-97ea-3c7abdf5756d 52125-844 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20140220 ANDA ANDA065405 REMEDYREPACK INC. AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-844_cf6757b9-bbd8-4b77-96bc-d0498b95b816 52125-844 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20141030 ANDA ANDA065405 REMEDYREPACK INC. AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52125-846_07d7be94-ec18-4fd9-a09c-e0e987eb3c21 52125-846 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20140220 ANDA ANDA077739 REMEDYREPACK INC. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-849_33a4057d-396b-4962-a28b-b17329284370 52125-849 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20140801 ANDA ANDA076407 REMEDYREPACK INC. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-849_581154ce-8542-430b-b126-18af5b186a2d 52125-849 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20140226 ANDA ANDA076407 REMEDYREPACK INC. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52125-851_d6a704e2-0dd2-4503-b81b-2a8bb685616c 52125-851 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20140226 ANDA ANDA077206 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-852_e6fbed47-a49a-4b67-b314-ffebf35d7cb8 52125-852 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20140226 ANDA ANDA090278 REMEDYREPACK INC. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-853_95c54e0d-8b15-44d9-8bc8-af5e4c81efc2 52125-853 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20140228 NDA NDA021990 REMEDYREPACK INC. AMLODIPINE BESYLATE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-854_e68458c8-4761-4195-8ef0-0abe52fa1640 52125-854 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET ORAL 20140228 ANDA ANDA078604 REMEDYREPACK INC. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-856_594928fa-9a4e-4b2e-8e3c-77ce3f1db3b1 52125-856 HUMAN PRESCRIPTION DRUG ADVAIRDISKUS DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20140228 NDA NDA021077 REMEDYREPACK INC. FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 250; 50 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 52125-857_e3864073-7956-40d1-a0f9-1943b9df02f9 52125-857 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20140303 ANDA ANDA065489 REMEDYREPACK INC. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 52125-858_b7f35118-c992-4dc2-a2d4-428dd364d86b 52125-858 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20140303 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-859_1e1a3d13-d2e8-4449-adf3-724ce0fded93 52125-859 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20140303 ANDA ANDA077560 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 52125-860_5694a847-ffa6-46a9-8bb5-e457662513f1 52125-860 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20140303 ANDA ANDA040804 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 52125-861_66aabe1b-bfb5-4873-9dee-f5801fc0cb65 52125-861 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20140303 NDA NDA021995 REMEDYREPACK INC. SITAGLIPTIN PHOSPHATE 100 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 52125-862_54e010b2-815f-4817-8b6f-143953954266 52125-862 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140304 ANDA ANDA078787 REMEDYREPACK INC. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-863_5afeffb1-6d00-4bbb-bd9f-c9744531bebc 52125-863 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140304 ANDA ANDA078787 REMEDYREPACK INC. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-864_1f82e595-8e97-4ace-a057-542c6d259c35 52125-864 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20140304 ANDA ANDA090170 REMEDYREPACK INC. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 52125-865_a7bc7289-df41-44df-8dd9-9453f451f002 52125-865 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20140311 ANDA ANDA079098 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-866_47f31cd6-185d-4111-8baa-cba16cb6ba56 52125-866 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20140416 ANDA ANDA091426 REMEDYREPACK INC. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 52125-867_19d72865-a778-42ff-b496-787bad5369cb 52125-867 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140311 ANDA ANDA072928 REMEDYREPACK INC. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 52125-868_309adb6f-5743-4dad-bd43-d08840ac94c2 52125-868 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20140311 ANDA ANDA079098 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-869_27c65ecb-dcc2-464e-93ed-89a1b1942ba1 52125-869 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20140311 ANDA ANDA089059 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 52125-869_d0e10518-4ba7-4fdd-8b35-e1fad09217d2 52125-869 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20140311 ANDA ANDA089059 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 52125-870_6c840a8d-1232-4261-87bf-e4297619dfd6 52125-870 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20140311 ANDA ANDA077050 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-872_d24a27fe-efaa-48a7-b273-baf160269f39 52125-872 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140311 ANDA ANDA065442 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 52125-872_dfca0270-52d6-479e-9035-37389ce2d5b7 52125-872 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140311 ANDA ANDA065442 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 52125-874_0ec4aee9-4025-41be-a59c-29b3d5c0367a 52125-874 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20140311 ANDA ANDA078406 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-875_cfa348b1-138b-40f0-901f-0c1266ebfad5 52125-875 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20140312 ANDA ANDA077794 REMEDYREPACK INC. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-876_7d59f145-598f-43cc-ace3-d9f377210b42 52125-876 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20140312 ANDA ANDA090278 REMEDYREPACK INC. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-877_8bd8eaa5-8d43-4a60-99d2-eb1266b259f8 52125-877 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20140317 ANDA ANDA077206 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-878_8c72b58b-480c-4da7-be94-c7f2052ceced 52125-878 HUMAN PRESCRIPTION DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride CAPSULE ORAL 20140317 ANDA ANDA078801 REMEDYREPACK INC. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-879_d178d56e-b1da-4336-a893-3e0dd6296e03 52125-879 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20140317 ANDA ANDA076273 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 52125-880_efbc0cfd-45d5-43e1-be62-1bcaff4524f4 52125-880 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20140319 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52125-881_45cbd5e4-354f-415c-8ab3-73294ea1aebb 52125-881 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20140319 ANDA ANDA070920 REMEDYREPACK INC. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 52125-882_c1dcfe97-a474-4bb1-b4aa-67a6b5176e07 52125-882 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140319 ANDA ANDA075932 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 52125-884_ff51aad7-df68-4354-a0be-ace362387c6d 52125-884 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20140325 ANDA ANDA086067 REMEDYREPACK INC. ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 52125-886_fec2c0a6-3d78-428d-8838-a3b6dc6d1a2c 52125-886 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate hydrocortisone butyrate CREAM TOPICAL 20140401 NDA NDA018514 REMEDYREPACK INC. HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52125-888_03be150f-61c6-4388-ad08-0064838bb551 52125-888 HUMAN PRESCRIPTION DRUG Tranylcypromine Sulfate tranylcypromine sulfate TABLET ORAL 20140401 NDA NDA012342 REMEDYREPACK INC. TRANYLCYPROMINE SULFATE 10 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] 52125-890_ca3a8f2b-99e9-4542-b031-e7de969c3c13 52125-890 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20140401 ANDA ANDA078243 REMEDYREPACK INC. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-894_8a961ae6-150a-43e3-b475-ea2df1a81a6c 52125-894 HUMAN PRESCRIPTION DRUG Amlodipine Besylate AMLODIPINE BESYLATE TABLET ORAL 20140404 ANDA ANDA078552 REMEDYREPACK INC. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-895_3661a691-f877-4eb2-809d-fb6779ea329a 52125-895 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140404 ANDA ANDA075994 REMEDYREPACK INC. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 52125-896_03f4321f-d057-4157-bba7-dfd4d7b05d48 52125-896 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20140404 ANDA ANDA084363 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 52125-897_f76b60ee-5baa-40d1-a219-f952fe1b13e7 52125-897 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20140409 ANDA ANDA090467 REMEDYREPACK INC. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 52125-898_cfd8d13b-ad14-4a5c-9149-33b4516560ba 52125-898 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20140409 ANDA ANDA079098 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-899_00386e40-772a-44eb-bc2b-c2bf8bb04973 52125-899 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 20140428 NDA NDA018810 REMEDYREPACK INC. SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 52125-899_35f58521-aefb-4498-83ff-3a9fcbaa7228 52125-899 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 20141028 NDA NDA018810 REMEDYREPACK INC. SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 52125-900_1fe89172-1343-40a0-a9e4-bdcf64ab6a3c 52125-900 HUMAN PRESCRIPTION DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride CAPSULE ORAL 20140409 ANDA ANDA078801 REMEDYREPACK INC. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-902_6ebb0fb9-9b73-459f-ae5f-d6f6455cd809 52125-902 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20140410 ANDA ANDA078406 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-903_bee7da20-3a51-456d-9963-a5829efc394e 52125-903 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20140414 NDA NDA019129 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 52125-904_110ec9db-8dda-42ea-8249-55cc296d24f0 52125-904 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20140414 ANDA ANDA077745 REMEDYREPACK INC. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 52125-905_91d0adbb-0669-4e10-a7a8-b9f94cffd8e2 52125-905 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20140414 ANDA ANDA078902 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-906_bbf217c7-452c-4404-901f-2997df723ab3 52125-906 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20140414 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-909_c04383f3-ddf1-46d1-b056-2ddaf7fae067 52125-909 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20140414 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-910_a77e3182-83dd-463e-9b66-0220b7d99c45 52125-910 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20140415 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 52125-911_74a48a1e-959e-416c-8c49-e59b06066d81 52125-911 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20140415 ANDA ANDA079098 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-912_4671ffad-078f-408b-a582-7cb5d36612d5 52125-912 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 20140418 ANDA ANDA040254 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 52125-913_f0d355cf-f7e3-47d3-bbfc-30bfbba716a5 52125-913 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140418 ANDA ANDA077754 REMEDYREPACK INC. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 52125-914_42155f74-a656-4d63-ab6e-7e6942cc4bbd 52125-914 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20140421 ANDA ANDA090278 REMEDYREPACK INC. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-916_5cc59467-52fb-46a2-aea7-16bf519a5240 52125-916 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140424 ANDA ANDA090901 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 52125-917_94cc49a6-5fba-47fb-ae3b-18536090e056 52125-917 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140423 ANDA ANDA076255 REMEDYREPACK INC. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 52125-918_8c7203af-28ce-482a-bae1-37611ab40bae 52125-918 HUMAN PRESCRIPTION DRUG Exforge HCT amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20140424 NDA NDA022314 REMEDYREPACK INC. AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5; 25; 160 mg/1; mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-920_41d61e3b-65ba-4a48-ad74-533b5b69d83c 52125-920 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20141106 ANDA ANDA090478 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 52125-920_d4f42ae3-792f-459e-bf94-b57f303dd013 52125-920 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20140801 ANDA ANDA090478 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 52125-923_c0e1fd5c-02a9-4de6-810c-5e489a93c04f 52125-923 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20140424 ANDA ANDA077739 REMEDYREPACK INC. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-923_cdf1dc48-5d7f-4e38-9b6e-91b52d4a5a5a 52125-923 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20140825 ANDA ANDA077739 REMEDYREPACK INC. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-924_b3be209f-99fe-4d9c-812a-149730f52f7e 52125-924 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140424 ANDA ANDA090694 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-925_a5267ff2-6630-42ba-820e-79c94eb86328 52125-925 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20140425 ANDA ANDA077560 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 52125-926_67251e35-5226-4502-b958-143ce14a2e3b 52125-926 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20140425 NDA NDA021515 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 52125-929_8a49c786-6dab-4e26-a636-7cb044d5ffcb 52125-929 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20140501 ANDA ANDA091305 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-931_80a750b5-0fec-4302-98cb-2dea31c1d1bc 52125-931 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20140507 ANDA ANDA077754 REMEDYREPACK INC. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 52125-932_75aa8882-c822-455d-b00b-c8441fe1bd85 52125-932 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20140507 ANDA ANDA075498 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-933_9fc38d06-8123-4d77-b327-e0428744dd3f 52125-933 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20140507 ANDA ANDA091240 REMEDYREPACK INC. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-935_30a7e22a-23a5-4e33-af87-7cf06f52bdf9 52125-935 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20140508 ANDA ANDA078955 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52125-936_e87d0e6e-cf7d-4839-a3d4-77a784d49fd2 52125-936 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20140512 ANDA ANDA074174 REMEDYREPACK INC. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 52125-937_f2677e1c-5e58-4b11-add5-130505b6ff35 52125-937 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20140513 ANDA ANDA070278 REMEDYREPACK INC. HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] 52125-938_f4deb479-0f1e-4741-b94d-6e1ae5d4d4b9 52125-938 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140513 ANDA ANDA065442 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 52125-938_f54ff9db-656a-4c94-8d55-8efcaf6b0c53 52125-938 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140519 ANDA ANDA065442 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 52125-939_b2f34b1d-2b50-47ba-b2bb-621b1b2b3431 52125-939 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20140519 ANDA ANDA090170 REMEDYREPACK INC. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 52125-941_8c0f52ce-c73b-41f3-970e-c6a507b1be02 52125-941 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140522 ANDA ANDA075350 REMEDYREPACK INC. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-942_181bf976-3f91-4b19-808c-54f30e601dd6 52125-942 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20140521 ANDA ANDA090695 REMEDYREPACK INC. LOXAPINE SUCCINATE 10 mg/1 52125-947_5e875ab6-91a1-4000-b3a3-1d21d581bc5f 52125-947 HUMAN PRESCRIPTION DRUG Denavir penciclovir CREAM TOPICAL 20140527 NDA NDA020629 REMEDYREPACK INC. PENCICLOVIR 10 mg/g DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 52125-948_b2b9e02b-fffd-47e1-85ec-d3d913133c4c 52125-948 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20140523 ANDA ANDA077425 REMEDYREPACK INC. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 52125-950_e717c3c5-bae1-4a92-bb61-dc132d4a54e3 52125-950 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140523 ANDA ANDA077754 REMEDYREPACK INC. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 52125-951_41519de8-c8b0-41c7-8c5e-d22812222523 52125-951 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20140527 ANDA ANDA080936 REMEDYREPACK INC. ISONIAZID 100 mg/1 Antimycobacterial [EPC] 52125-952_4e336294-8e8f-473f-9c06-ec08f3bab421 52125-952 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20140527 ANDA ANDA076161 REMEDYREPACK INC. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-953_a214c88c-c377-4acb-ade4-f802de6ff133 52125-953 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20140528 ANDA ANDA077031 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-954_5b7730d8-2586-4906-9651-eee4658fbcd9 52125-954 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20140528 ANDA ANDA077380 REMEDYREPACK INC. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 52125-955_21248d78-aae0-4232-9886-44cc5ccdc3d0 52125-955 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20140528 ANDA ANDA077745 REMEDYREPACK INC. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 52125-956_a59ec3f1-56fb-4825-ba24-36d763aeab17 52125-956 HUMAN PRESCRIPTION DRUG Abacavir Abacavir TABLET ORAL 20140529 ANDA ANDA091560 REMEDYREPACK INC. ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 52125-957_03fddf42-e75b-4618-abae-f4502ad2a120 52125-957 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140603 ANDA ANDA088832 REMEDYREPACK INC. PREDNISONE 10 mg/1 52125-957_05801696-b38c-4fca-a4cb-d408b82a562d 52125-957 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140827 ANDA ANDA088832 REMEDYREPACK INC. PREDNISONE 10 mg/1 52125-957_988ba9b3-58b3-41a7-8bd5-56fe72adef70 52125-957 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140904 ANDA ANDA088832 REMEDYREPACK INC. PREDNISONE 10 mg/1 52125-957_e3a33ac8-c28b-4d60-bd26-7ea9bcd21aab 52125-957 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140904 ANDA ANDA088832 REMEDYREPACK INC. PREDNISONE 10 mg/1 52125-958_07de2aee-f350-49ef-8f88-9f71e051f18e 52125-958 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20140603 ANDA ANDA077147 REMEDYREPACK INC. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 52125-959_d7ffe56b-372b-4abc-bebe-6a59d9ad2d16 52125-959 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20140603 ANDA ANDA075480 REMEDYREPACK INC. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 52125-960_a4dca73a-4a77-4410-9658-895863a980a5 52125-960 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20140603 ANDA ANDA076273 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 52125-961_a41fcc46-9583-4f0b-ae8d-8a37fb93b6f8 52125-961 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140605 ANDA ANDA076255 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 52125-962_58d2fd19-3b61-4af1-9385-d812fd210833 52125-962 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20140605 ANDA ANDA078558 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-963_c2a3ad75-565d-43fa-aadd-7b06062690c2 52125-963 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20140605 ANDA ANDA078558 REMEDYREPACK INC. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-965_499c3fe1-e948-4e48-a1aa-917da3a0d9e8 52125-965 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20140611 ANDA ANDA075520 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 52125-966_93857279-8aee-4a05-a57c-419fec6fe690 52125-966 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20140611 ANDA ANDA090970 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 52125-967_f285d1b6-7cc2-48b2-93be-a9043613fd1b 52125-967 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20140611 ANDA ANDA078406 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52125-968_a8e8b7d9-92f6-456f-8099-da79c6776aaf 52125-968 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20140611 ANDA ANDA086962 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 52125-969_33d9b032-815a-47b6-aa51-3dcaacd8cb0c 52125-969 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20140611 ANDA ANDA089098 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 52125-970_e5863270-7e30-4e90-8c32-9421811cbed9 52125-970 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140616 NDA AUTHORIZED GENERIC NDA019684 REMEDYREPACK INC. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-971_034dd1e3-bd0f-4d07-a76c-f3b17684e709 52125-971 HUMAN PRESCRIPTION DRUG glipizide glipizide TABLET ORAL 20140904 ANDA ANDA077820 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-971_945abe72-be25-40de-9ab8-2c31e3a852c0 52125-971 HUMAN PRESCRIPTION DRUG glipizide glipizide TABLET ORAL 20140616 ANDA ANDA077820 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-971_958618e2-612e-4129-be56-dd6ad9c34d9d 52125-971 HUMAN PRESCRIPTION DRUG glipizide glipizide TABLET ORAL 20141216 ANDA ANDA077820 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-971_a2f7262a-05ce-450b-9573-67e1903ef88b 52125-971 HUMAN PRESCRIPTION DRUG glipizide glipizide TABLET ORAL 20140616 ANDA ANDA077820 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-972_006ba75b-d590-4d28-864e-ddd7888b22a0 52125-972 HUMAN PRESCRIPTION DRUG glipizide glipizide TABLET ORAL 20140616 ANDA ANDA077820 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-972_a306daf7-2cb6-4ca3-9fe5-190f0340e6b6 52125-972 HUMAN PRESCRIPTION DRUG glipizide glipizide TABLET ORAL 20141126 ANDA ANDA077820 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-972_bbe82e56-704c-40fc-af4a-15a725a6b586 52125-972 HUMAN PRESCRIPTION DRUG glipizide glipizide TABLET ORAL 20141014 ANDA ANDA077820 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-972_e6b80323-36e1-4476-96ff-59a889f52e17 52125-972 HUMAN PRESCRIPTION DRUG glipizide glipizide TABLET ORAL 20140616 ANDA ANDA077820 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52125-973_3aa6d5ae-cd63-4ffd-93dd-7cc0a5162e48 52125-973 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20140616 ANDA ANDA040682 REMEDYREPACK INC. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 52125-974_9291f8d9-6a78-4c38-b4d7-a95fbf46175a 52125-974 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20140616 NDA NDA022122 REMEDYREPACK INC. DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52125-976_9f55fd5a-01e6-43c9-a3f6-f759042c0431 52125-976 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20140616 ANDA ANDA074979 REMEDYREPACK INC. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 52125-977_9aaeb5c4-fee9-412b-8290-ef1a0519a02b 52125-977 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20140624 ANDA ANDA077560 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 52125-978_2d2b2d04-a79b-40a6-9946-179fd7db938e 52125-978 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20140624 ANDA ANDA091426 REMEDYREPACK INC. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 52125-980_c2b89b36-fb2e-4c44-8bc2-4892b4b55ff4 52125-980 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET ORAL 20140627 ANDA ANDA071881 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52125-981_337354de-f10e-45a8-b327-cea61b67e218 52125-981 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20140627 ANDA ANDA077794 REMEDYREPACK INC. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-982_559488d2-c16b-4c33-999f-9267c2950e79 52125-982 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140707 ANDA ANDA077284 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 52125-983_3218f592-f89b-46ad-96a8-3c3d79d5d583 52125-983 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE SOLUTION INTRAVENOUS 20140707 ANDA ANDA078287 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-983_f96e9ba0-524a-4353-8a96-07b794a5b48c 52125-983 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE SOLUTION INTRAVENOUS 20141020 ANDA ANDA078287 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52125-984_21c45852-0520-451e-aa54-9f27f189d2d6 52125-984 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20140707 ANDA ANDA202764 REMEDYREPACK INC. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52125-985_f3714f1f-caff-4f43-a3a5-bbb81bf7bee2 52125-985 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20140709 ANDA ANDA090120 REMEDYREPACK INC. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 52125-986_45b4619d-d7ed-44b3-9559-645994299da8 52125-986 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20140709 ANDA ANDA090527 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 52125-988_4056c2d5-3289-4b30-99fc-e5826517ba7b 52125-988 HUMAN PRESCRIPTION DRUG Depakote Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20140714 NDA NDA018723 REMEDYREPACK INC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 52125-989_73f91709-c31d-4f87-b3da-8055be1e7d07 52125-989 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20140714 NDA AUTHORIZED GENERIC NDA020504 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 52125-990_2f927eca-0c17-4b16-809e-fd6d2af70709 52125-990 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20140718 ANDA ANDA077901 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 52125-991_3533a3f1-9e25-45f0-a546-a23e2dbb4298 52125-991 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140718 ANDA ANDA078866 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 52125-992_970b4633-f8b5-407e-98b0-b46e4397e2df 52125-992 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20140801 ANDA ANDA074739 REMEDYREPACK INC. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 52125-993_fb6c090c-78d2-43e7-b28b-68613d8c7d3f 52125-993 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140729 ANDA ANDA090649 REMEDYREPACK INC. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52125-994_a680148c-6afb-44ea-a331-03ceb2d1462c 52125-994 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20140801 ANDA ANDA078225 REMEDYREPACK INC. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52125-996_7763749f-b083-4bf4-a60b-c9453884db1a 52125-996 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140801 ANDA ANDA083677 REMEDYREPACK INC. PREDNISONE 20 mg/1 52125-997_b9ba2e6f-e7ff-46a1-843d-be5c67a43c20 52125-997 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20140801 ANDA ANDA078327 REMEDYREPACK INC. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 52125-999_bd4024be-6d91-46c4-891d-3c4c19cf0c0c 52125-999 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20140801 ANDA ANDA074151 REMEDYREPACK INC. CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 52137-1001_e1219890-121d-49be-8014-2edb2ec241dd 52137-1001 HUMAN OTC DRUG THERAPY PAIN MENTHOL METHYL SALICYLATE CAPSAICIN GEL TOPICAL 20121129 OTC MONOGRAPH NOT FINAL part348 Health Specialty.com CAPSAICIN; MENTHOL; METHYL SALICYLATE .025; 10; 28 g/100g; g/100g; g/100g 52138-100_95c44325-705f-4014-a9fa-83de7a3df3c1 52138-100 HUMAN OTC DRUG CLEANpHIRST Alcohol Free Antiseptic Hand Sanitizer BENZALKONIUM CHLORIDE GEL TOPICAL 20100512 OTC MONOGRAPH FINAL part333 Cleanphirst, LLC BENZALKONIUM CHLORIDE .13 mL/100mL 52138-200_92b6dcf6-7786-4e83-8211-73ae66e723f9 52138-200 HUMAN OTC DRUG TD Take Down Alcohol Free Antiseptic Hand Sanitizer BENZALKONIUM CHLORIDE GEL TOPICAL 20100331 OTC MONOGRAPH FINAL part333 Cleanphirst, LLC BENZALKONIUM CHLORIDE .13 mL/100mL 52142-001_a03d1c34-feca-4325-a8a4-5543d89d5b6d 52142-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19900101 NDA NDA205865 Adirondack Compressed Gases, Inc OXYGEN 99 L/100L 52146-1001_aab6ec68-7848-4a67-82dc-6f5b5636eb0f 52146-1001 HUMAN OTC DRUG Denpo cavity prevention fluoride TABLET, CHEWABLE ORAL 20100318 UNAPPROVED DRUG OTHER Suheung Capsule Co., Ltd SODIUM FLUORIDE 1.1 mg/1 52164-1101_3ecda643-f738-47fe-b2ce-8b05975d4569 52164-1101 HUMAN OTC DRUG ARC 42 Essential First Aid Items ISOPROPYL ALCOHOL KIT 20100429 OTC MONOGRAPH FINAL part345 American Red Cross 52164-1102_d116b344-c454-4d0f-ad37-0d88301e7565 52164-1102 HUMAN OTC DRUG ARC FIRST AID Contains 101 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN KIT 20100429 OTC MONOGRAPH FINAL part333 American Red Cross 52164-1103_b45576b9-c77e-4d28-ac35-44d5ee9982d5 52164-1103 HUMAN OTC DRUG ARC FIRST AID Contains 101 PIECES Hardcase BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN KIT 20100428 OTC MONOGRAPH FINAL part333 American Red Cross 52164-1104_3bc2e75a-0863-40ce-8f64-7ec7d56aee19 52164-1104 HUMAN OTC DRUG ARC Emergency Preparedness FIRST AID Contains 202 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN KIT 20100427 OTC MONOGRAPH FINAL part333 American Red Cross 52164-1105_11272c2b-c459-4cae-9248-4646a532e736 52164-1105 HUMAN OTC DRUG ARC FIRST AID Contains 303 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL,BENZOCAINE,ALCOHOL, ASPIRIN,BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE KIT 20100429 OTC MONOGRAPH FINAL part333 American Red Cross 52164-1106_badbeb85-1c35-4220-ae61-bf5052b41feb 52164-1106 HUMAN OTC DRUG ARC FIRST AID Contains 303 PIECES HARDCASE BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL,BENZOCAINE,ALCOHOL, ASPIRIN KIT 20100428 OTC MONOGRAPH FINAL part333 American Red Cross 52164-1107_6abbad39-121a-4516-86f7-44bff245d21b 52164-1107 HUMAN OTC DRUG ARC FIRST AID Contains 404 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN KIT 20100427 OTC MONOGRAPH FINAL part333 American Red Cross 52164-1108_50656ad8-a6ab-451b-90ff-dcce11587476 52164-1108 HUMAN OTC DRUG ARC FIRST AID Contains 1000 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN KIT 20100602 OTC MONOGRAPH FINAL part333 American Red Cross 52164-1109_1d471d7f-c440-42c0-a013-ed9e2dd902f0 52164-1109 HUMAN OTC DRUG ARC FIRST AID Emergency Preparedness Contains 167 PIECES BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN, KIT 20100428 OTC MONOGRAPH FINAL part344 American Red Cross 52164-1120_1ef38df7-8cb4-4909-9de8-edbb4675fa8d 52164-1120 HUMAN OTC DRUG The New Parent First Aid BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE, ISOPROPYL ALCOHOL, ALCOHOL KIT 20100507 OTC MONOGRAPH FINAL part333 American Red Cross 52166-001_428eea13-dd5f-41a3-a906-261c5bb83c19 52166-001 HUMAN OTC DRUG Argentyn 23 Argentum Metallicaum GEL TOPICAL 20090101 UNAPPROVED HOMEOPATHIC Natural Immunogenics Corp. SILVER 30 [hp_X]/1 52166-002_2c269b2a-5de1-40fc-b438-0897345ccb2b 52166-002 HUMAN OTC DRUG Sovereign Silver Argentum Metallicum GEL TOPICAL 20090101 UNAPPROVED HOMEOPATHIC Natural Immunogenics Corp. SILVER 30 [hp_X]/1 52174-001_800eb696-6938-4c2c-b748-93d9906145eb 52174-001 HUMAN OTC DRUG Kleen Instant Hand Sanitizer with Moisturizers ALCOHOL LIQUID TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part333 Ningbo Kleen Products Co., Ltd. ALCOHOL 62 g/100g 52174-002_50016185-3b35-4112-870a-36545dc5c1d1 52174-002 HUMAN OTC DRUG Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100908 OTC MONOGRAPH NOT FINAL part333E Ningbo Kleen Products Co., Ltd. ALCOHOL 62 g/100g 52183-088_2e79a844-0525-4788-af34-935b3dd04f9e 52183-088 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Blacksmith Brands Inc. CETIRIZINE HYDROCHLORIDE 5 mg/5mL 52183-199_e874fa70-18b3-4b16-b5a7-5b0176863884 52183-199 HUMAN OTC DRUG NasalCrom cromolyn sodium SPRAY, METERED NASAL 20091029 ANDA ANDA075702 Prestige Brands Holdings, Inc. CROMOLYN SODIUM 5.2 mg/1 52183-229_fc79d582-2c6d-4647-9504-7a46fd1e7e14 52183-229 HUMAN OTC DRUG Ludens Wild Cherry Throat Drops Pectin LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 2.8 mg/1 52183-239_b5b745c2-610b-46e6-bb93-ab3a2aa20a38 52183-239 HUMAN OTC DRUG Ludens Wild Honey Throat Drops Pectin LOZENGE ORAL 20100708 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 2.8 mg/1 52183-249_49903bcc-24f1-41ed-90ab-c4c247e1f876 52183-249 HUMAN OTC DRUG Ludens Sugar Free Wild Cherry Throat Pectin LOZENGE ORAL 20100712 OTC MONOGRAPH NOT FINAL part356 Blacksmith Brands, Inc. PECTIN 2.8 mg/1 52183-255_a789d1c9-c18c-4a72-9cf2-44d50c2732bd 52183-255 HUMAN OTC DRUG Ludens Honey Licorice Throat Drops Menthol LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. MENTHOL 1.6 mg/1 52183-259_a789d1c9-c18c-4a72-9cf2-44d50c2732bd 52183-259 HUMAN OTC DRUG Ludens Honey Licorice Throat Drops Menthol LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. MENTHOL 1 mg/1 52183-266_a789d1c9-c18c-4a72-9cf2-44d50c2732bd 52183-266 HUMAN OTC DRUG Ludens Honey Lemon Throat Drops Menthol LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. MENTHOL 1.6 mg/1 52183-269_a789d1c9-c18c-4a72-9cf2-44d50c2732bd 52183-269 HUMAN OTC DRUG Ludens Honey Lemon Throat Drops Menthol LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. MENTHOL 1 mg/1 52183-279_a789d1c9-c18c-4a72-9cf2-44d50c2732bd 52183-279 HUMAN OTC DRUG Ludens Original Menthol Throat Drops Menthol LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. MENTHOL 2.5 mg/1 52183-289_fc79d582-2c6d-4647-9504-7a46fd1e7e14 52183-289 HUMAN OTC DRUG Ludens Berry Assortment Throat Drops Pectin LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 2.8 mg/1 52183-299_fc79d582-2c6d-4647-9504-7a46fd1e7e14 52183-299 HUMAN OTC DRUG Ludens Wild Cherry Throat Drops Pectin LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 1.7 mg/1 52183-325_491ebb0e-53f4-4a62-b17a-c841c6be6572 52183-325 HUMAN OTC DRUG PediaCare Childrens Fever Reducer Pain Reliever Dye Free Acetaminophen LIQUID ORAL 20100802 OTC MONOGRAPH NOT FINAL part343 Blacksmith Brands, Inc. ACETAMINOPHEN 160 mg/5mL 52183-335_826a62d3-b887-4ebc-8bc5-97d35c9ebee5 52183-335 HUMAN OTC DRUG PediaCare Childrens Fever Reducer Pain Reliever Cherry Acetaminophen LIQUID ORAL 20100708 OTC MONOGRAPH NOT FINAL part343 Blacksmith Brands, Inc. ACETAMINOPHEN 160 mg/5mL 52183-345_3865e62b-0f27-4bbf-8859-508e5c4ab973 52183-345 HUMAN OTC DRUG PediaCare Childrens Fever Reducer Pain Reliever Grape Acetaminophen LIQUID ORAL 20100709 OTC MONOGRAPH NOT FINAL part343 Blacksmith Brands, Inc. ACETAMINOPHEN 160 mg/5mL 52183-353_c091d86a-c2de-422c-ad25-a3c41e748b83 52183-353 HUMAN OTC DRUG PediaCare Infants Gas Relief Dye Free Simethicone LIQUID ORAL 20101012 OTC MONOGRAPH FINAL part332 Blacksmith Brands, Inc. DIMETHICONE; SILICON DIOXIDE 6.3; .37 mg/mL; mg/mL 52183-355_b03623ad-3dfb-4c76-afbf-592671419fab 52183-355 HUMAN OTC DRUG PediaCare Childrens Plus Cough and Sore Throat Dextromethorphan Hydrobromide and Acetaminophen LIQUID ORAL 20100709 OTC MONOGRAPH FINAL part341 Blacksmith Brands, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 5 mg/5mL; mg/5mL 52183-359_e9e31c60-4bb9-47e6-a6d8-2e5c052aa81c 52183-359 HUMAN OTC DRUG PediaCare Childrens MultiSymptom Cold Dextromethorphan HBr and Phenylephrine HCl LIQUID ORAL 20091029 OTC MONOGRAPH FINAL part341 Prestige Brands Holdings, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 52183-363_687151cb-a6be-471a-95ff-ae6ab5c0b307 52183-363 HUMAN OTC DRUG PediaCare Infants Gas Relief Simethicone LIQUID ORAL 20101012 OTC MONOGRAPH FINAL part332 Blacksmith Brands, Inc. DIMETHICONE; SILICON DIOXIDE 6.3; .37 mg/mL; mg/mL 52183-365_21307dd0-840b-4ae5-b024-eeedfed735eb 52183-365 HUMAN OTC DRUG PediaCare Childrens Plus Flu Chloropheniramine Maleate and Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride and Ace LIQUID ORAL 20100709 OTC MONOGRAPH FINAL part341 Blacksmith Brands, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL 52183-369_3bd1f4a2-f793-487f-ba48-02d10a4c328e 52183-369 HUMAN OTC DRUG PediaCare LongActing Cough Dextromethorphan HBr LIQUID ORAL 20091029 OTC MONOGRAPH FINAL part341 Blacksmith Brands, Inc. DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg/5mL 52183-373_8c0df5e7-a958-42a7-8ba8-6dea4fc92890 52183-373 HUMAN OTC DRUG PediaCare Infants Fever Reducer Grape Acetaminophen LIQUID ORAL 20100803 OTC MONOGRAPH NOT FINAL part343 Blacksmith Brands, Inc. ACETAMINOPHEN 80 mg/.8mL 52183-375_8ca9607e-470f-46fd-a08e-a44d6088c165 52183-375 HUMAN OTC DRUG PediaCare Childrens Plus Cough and Runny Nose Chloropheniramine Maleate and Dextromethorphan Hydrobromide and Acetaminophen LIQUID ORAL 20100709 OTC MONOGRAPH FINAL part341 Blacksmith Brands, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL 52183-379_2c689cf3-fca1-4230-98c7-9b224bf20a05 52183-379 HUMAN OTC DRUG diaCare Childrens Decongestant Phenylephrine HCl LIQUID ORAL 20091029 OTC MONOGRAPH FINAL part341 Blacksmith Brands, Inc. PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL 52183-383_585026ca-a149-4e96-a9c8-7c0e1e993171 52183-383 HUMAN OTC DRUG PediaCare Infants Fever Reducer Dye Free Acetaminophen LIQUID ORAL 20100728 OTC MONOGRAPH NOT FINAL part343 Blacksmith Brands, Inc. ACETAMINOPHEN 80 mg/.8mL 52183-385_44d404ec-3375-4b8c-ad4e-8181013152a7 52183-385 HUMAN OTC DRUG PediaCare Childrens Plus Multisymptom Cold Chloropheniramine Maleate and Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride and Acet LIQUID ORAL 20100709 OTC MONOGRAPH FINAL part341 Blacksmith Brands, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL 52183-389_f38b1e3b-e0ed-4d53-b892-036bf21bf6ff 52183-389 HUMAN OTC DRUG PediaCare Childrens Allergy and Cold Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride LIQUID ORAL 20091029 OTC MONOGRAPH FINAL part341 Blacksmith Brands, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 12.5; 5 mg/5mL; mg/5mL 52183-393_317883ab-c8bb-4750-8238-45776f6ffc30 52183-393 HUMAN OTC DRUG PediaCare Infants Fever Reducer Cherry Acetaminophen LIQUID ORAL 20100827 OTC MONOGRAPH NOT FINAL part343 Blacksmith Brands, Inc. ACETAMINOPHEN 80 mg/.8mL 52183-395_f96c8c91-b9d3-48f8-a306-cdffa06998dc 52183-395 HUMAN OTC DRUG PediaCare Childrens Cough and Congestion Dextromethorphan Hydrobromide and Guaifenesin LIQUID ORAL 20100712 OTC MONOGRAPH FINAL part341 Blacksmith Brands, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 52183-399_a78361b9-b342-40a1-be37-34b426f02aac 52183-399 HUMAN OTC DRUG Pediacare Childrens Allergy Diphenhydramine HCl LIQUID ORAL 20091029 OTC MONOGRAPH FINAL part341 Blacksmith Brands, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 52183-499_a78361b9-b342-40a1-be37-34b426f02aac 52183-499 HUMAN OTC DRUG Pediacare Childrens Allergy Diphenhydramine HCl LIQUID ORAL 20100201 OTC MONOGRAPH FINAL part341 Blacksmith Brands, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 52188-515_8cfa64c8-f34e-480a-b86a-6d04b053c881 52188-515 HUMAN OTC DRUG Aftermath Hand Sanitizer HUSKY 515 GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 Aftermath Inc. ETHANOL 600 mL/1000mL 52193-001_66b7ecd0-ba08-43b8-9850-32bb3cfa7f9a 52193-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100131 UNAPPROVED MEDICAL GAS Care Medical Oxygen and Home Supplies OXYGEN 99 L/100L 52200-001_6b1bffe0-00bc-4273-bc09-d81155c31059 52200-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19810101 UNAPPROVED MEDICAL GAS Home Care Medical LLC OXYGEN 99 L/100L 52204-103_495838f0-f2a7-465b-b5e0-4c57e23c86c8 52204-103 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, COATED ORAL 20110214 OTC MONOGRAPH FINAL part343 Cispharma, Inc ASPIRIN 81 mg/1 52204-111_8c174fea-0c59-4e24-baf0-e767f2dc572b 52204-111 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, COATED ORAL 20101115 OTC MONOGRAPH FINAL part343 Cispharma, Inc ASPIRIN 325 mg/1 52204-113_b33ff1bc-26be-4b1c-bcee-03a1c15015fd 52204-113 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20110328 OTC MONOGRAPH NOT FINAL part343 Cispharma, Inc ACETAMINOPHEN 325 mg/1 52204-114_d456e868-688a-4f9b-a7df-7c7087ab37ee 52204-114 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20110328 OTC MONOGRAPH NOT FINAL part343 Cispharma, Inc ACETAMINOPHEN 500 mg/1 52204-115_5db40826-6093-4adc-8f00-eeaffda69e7f 52204-115 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20110328 OTC MONOGRAPH NOT FINAL part343 Cispharma, Inc ACETAMINOPHEN 500 mg/1 52204-124_bbaaa8bb-d389-4ce2-ad82-d805ec281f72 52204-124 HUMAN OTC DRUG ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20110328 OTC MONOGRAPH NOT FINAL part343 Cispharma, Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 52205-001_2be512ee-2c1d-4860-ad8d-39f7117ee287 52205-001 HUMAN OTC DRUG Unagel SALICYLIC ACID CREAM TOPICAL 20120904 OTC MONOGRAPH FINAL part333D Advanced Skin Technology, LLC SALICYLIC ACID 2 g/100g 52205-002_d5568a8b-650c-4811-983a-2867580aab6c 52205-002 HUMAN OTC DRUG Aqualant DIMETHICONE OIL TOPICAL 20120904 OTC MONOGRAPH FINAL part347 Advanced Skin Technology, LLC DIMETHICONE 24.92 mL/100mL 52219-010_525e6897-f670-48d9-a468-22b08996e02a 52219-010 HUMAN OTC DRUG CYPRESS ESSENCE MASK PACK Witch Hazel PATCH TOPICAL 20120301 OTC MONOGRAPH FINAL part347 GREEN LIFE WITCH HAZEL .23 g/23mL 52227-100_32f8722a-d964-4d1d-9be8-b62c686f83f0 52227-100 HUMAN OTC DRUG BAROX MENTHOL GEL TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 KTAIGA CO., LTD. MENTHOL 3 g/120mL 52232-100_4252bcdd-2e1e-45bc-9716-1d46f1b99d82 52232-100 HUMAN OTC DRUG Pro1tek Antiseptic Foam Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100629 OTC MONOGRAPH NOT FINAL part333E Priority Environmental Solutions BENZALKONIUM CHLORIDE 1.3 mg/mL 52233-001_dd7dc678-c1f5-4c72-afd2-ad412e3258a3 52233-001 HUMAN PRESCRIPTION DRUG oxygen compressed oxygen GAS RESPIRATORY (INHALATION) 20100824 UNAPPROVED MEDICAL GAS Monroe Welding Supply, Inc. OXYGEN 992 mL/L 52233-003_cc73270f-eccc-4966-bd2b-63c7ae4dbe22 52233-003 HUMAN PRESCRIPTION DRUG nitrogen compressed nitrogen GAS RESPIRATORY (INHALATION) 20100822 UNAPPROVED MEDICAL GAS Monroe Welding Supply, Inc. NITROGEN 992 mL/L 52233-005_b1cbc715-bf35-44f7-91e4-3a186611fd51 52233-005 HUMAN PRESCRIPTION DRUG medical air compressed oxygen GAS RESPIRATORY (INHALATION) 20100822 UNAPPROVED MEDICAL GAS Monroe Welding Supply, Inc. NITROGEN; OXYGEN 790; 210 mL/L; mL/L 52241-100_a8e9296f-a16b-46a3-90e0-407662540807 52241-100 HUMAN OTC DRUG Katinko Pain And Itch Relieving CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE OINTMENT TOPICAL 20100524 OTC MONOGRAPH NOT FINAL part348 Greenstone Pharmaceutical H.K. Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 11; 7.6; 13 g/100g; g/100g; g/100g 52241-200_2ee5ef8e-4fe2-43af-a54a-61680f03669f 52241-200 HUMAN OTC DRUG Katinko Pain And Itch Relieving CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE OIL TOPICAL 20100524 OTC MONOGRAPH FINAL part348 Greenstone Pharmaceutical H.K. Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 11; 7.6; 13.5 g/100g; g/100g; g/100g 52241-300_5741c85f-da5d-402e-888d-6daea61ad6cb 52241-300 HUMAN OTC DRUG Katinko Pain And Itch Relieving CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE STICK TOPICAL 20100524 OTC MONOGRAPH FINAL part348 Greenstone Pharmaceutical H.K. Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 11; 7.6; 13.5 g/100g; g/100g; g/100g 52244-010_e8b8ec8d-1318-43e4-a182-446e9f9579de 52244-010 HUMAN PRESCRIPTION DRUG Edex alprostadil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 20120415 NDA NDA020649 Actient Pharmaceuticals, LLC ALPROSTADIL 10 ug/mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 52244-020_e8b8ec8d-1318-43e4-a182-446e9f9579de 52244-020 HUMAN PRESCRIPTION DRUG Edex alprostadil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 20120115 NDA NDA020649 Actient Pharmaceuticals, LLC ALPROSTADIL 20 ug/mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 52244-030_5201ac60-fb00-11e3-a3ac-0800200c9a66 52244-030 HUMAN PRESCRIPTION DRUG Striant testosterone TABLET BUCCAL 20030619 NDA NDA021543 Actient Pharmaceuticals LLC TESTOSTERONE 30 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 52244-040_e8b8ec8d-1318-43e4-a182-446e9f9579de 52244-040 HUMAN PRESCRIPTION DRUG Edex alprostadil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 20120315 NDA NDA020649 Actient Pharmaceuticals, LLC ALPROSTADIL 40 ug/mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 52244-100_85447644-7163-4e92-918f-203fa58ce1fe 52244-100 HUMAN PRESCRIPTION DRUG Theo-24 theophylline anhydrous CAPSULE, EXTENDED RELEASE ORAL 20140825 ANDA ANDA087942 Actient Pharmaceuticals LLC THEOPHYLLINE ANHYDROUS 100 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 52244-200_85447644-7163-4e92-918f-203fa58ce1fe 52244-200 HUMAN PRESCRIPTION DRUG Theo-24 theophylline anhydrous CAPSULE, EXTENDED RELEASE ORAL 20140825 ANDA ANDA087943 Actient Pharmaceuticals LLC THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 52244-300_85447644-7163-4e92-918f-203fa58ce1fe 52244-300 HUMAN PRESCRIPTION DRUG Theo-24 theophylline anhydrous CAPSULE, EXTENDED RELEASE ORAL 20140825 ANDA ANDA087944 Actient Pharmaceuticals LLC THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 52244-400_85447644-7163-4e92-918f-203fa58ce1fe 52244-400 HUMAN PRESCRIPTION DRUG Theo-24 theophylline anhydrous CAPSULE, EXTENDED RELEASE ORAL 20140825 ANDA ANDA081034 Actient Pharmaceuticals LLC THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 52244-404_d86c6a13-9e5f-43c2-92f5-c7ed7bfcedfc 52244-404 HUMAN PRESCRIPTION DRUG SEMPREX D acrivastine and pseudoephedrine hydrochloride CAPSULE ORAL 20120126 NDA NDA019806 Actient Pharmaceuticals, LLC ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE 8; 60 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 52244-429_0db1e8dd-b4fa-491b-a529-0fb939710759 52244-429 HUMAN PRESCRIPTION DRUG Robaxin Methocarbamol TABLET, FILM COATED ORAL 20120515 NDA NDA011011 Actient Pharmaceuticals, LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 52244-449_0db1e8dd-b4fa-491b-a529-0fb939710759 52244-449 HUMAN PRESCRIPTION DRUG Robaxin Methocarbamol TABLET, FILM COATED ORAL 20110818 NDA NDA011011 Actient Pharmaceuticals, LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 52244-920_7ec5ba03-6164-4199-a333-7cd8d7c75e17 52244-920 HUMAN PRESCRIPTION DRUG Dilatrate SR Isosorbide Dinitrate CAPSULE, EXTENDED RELEASE ORAL 20120215 NDA NDA019790 Actient Pharmaceuticals, LLC ISOSORBIDE DINITRATE 40 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 52246-929_adf6389f-108e-4a7d-8ef3-add976ffd0d9 52246-929 HUMAN PRESCRIPTION DRUG Natroba spinosad SUSPENSION TOPICAL 20110125 NDA NDA022408 ParaPRO LLC SPINOSAD 9 mg/mL Pediculicide [EPC] 52257-1001_edaef150-ae1a-4b6b-8058-a9b478cf6c20 52257-1001 HUMAN OTC DRUG ATOMY SUN CREAM SPF 50 PA OCTINOXATE CREAM TOPICAL 20100428 OTC MONOGRAPH NOT FINAL part352 ATOMY CO LTD OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 4.5; 3; 1.5; 2.9 mL/60mL; mL/60mL; mL/60mL; mL/60mL 52257-1002_6a66799a-c889-4a45-aefc-f12dd55349d6 52257-1002 HUMAN OTC DRUG ATOMY BB CREAM SPF 30 PA OCTINOXATE CREAM TOPICAL 20100429 OTC MONOGRAPH NOT FINAL part352 ATOMY CO LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; 3.2; .78 mL/40mL; mL/40mL; mL/40mL 52257-1003_9d1738e0-b637-4c23-8935-86295173b1f8 52257-1003 HUMAN OTC DRUG ATOMY TOOTHPASTE SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20100525 OTC MONOGRAPH FINAL part355 ATOMY CO LTD SODIUM FLUORIDE; SODIUM MONOFLUOROPHOSPHATE .2; .32 g/200g; g/200g 52257-1004_2ad667b8-581e-40da-9de8-331491c9f6f2 52257-1004 HUMAN OTC DRUG ATOMY HERBAL HAIR TONIC DEXPANTHENOL LIQUID TOPICAL 20100429 UNAPPROVED DRUG OTHER ATOMY CO LTD DEXPANTHENOL; LEVOMENTHOL; SALICYLIC ACID .4; .6; .5 mL/200mL; mL/200mL; mL/200mL 52257-1100_a0c66b35-53ec-4bdd-98ce-75f2b74f59f1 52257-1100 HUMAN OTC DRUG Fresh Med Solution GLYCERIN, ALCOHOL, GLYCERYL MONOSTEARATE LIQUID TOPICAL 20110718 OTC MONOGRAPH FINAL part347 ATOMY CO LTD ALCOHOL; GLYCERIN; GLYCERYL MONOSTEARATE 1.6; 1.744; .4 mL/40mL; mL/40mL; mL/40mL 52257-1110_6eca6fb4-d4e6-4dc4-95a8-8006cfdbef08 52257-1110 HUMAN OTC DRUG Calming Skin PANTHENOL, GLYCERIN, TOCOPHEROL LOTION TOPICAL 20110718 UNAPPROVED DRUG OTHER ATOMY CO LTD GLYCERIN; PANTHENOL; TOCOPHEROL .65; .65; .65 mL/130mL; mL/130mL; mL/130mL 52257-1200_b0874195-4256-4436-817d-818b4d0ba1c3 52257-1200 HUMAN OTC DRUG ATOMY MINERAL PACT SPF35 PA PLUS PLUS NO.13 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20100429 OTC MONOGRAPH FINAL part352 ATOMY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.2; .23 g/12g; g/12g 52257-1201_568f0324-2bcd-4e4a-afcd-657937e00e6f 52257-1201 HUMAN OTC DRUG ATOMY MINERAL PACT SPF35 PA PLUS PLUS NO.21 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20100429 OTC MONOGRAPH FINAL part352 ATOMY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.2; .23 g/12g; g/12g 52257-1202_a1bfd1f4-4c95-4620-8664-4624de7b9d6b 52257-1202 HUMAN OTC DRUG ATOMY MINERAL PACT SPF35 PA PLUS PLUS NO.23 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20100429 OTC MONOGRAPH FINAL part352 ATOMY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.2; .23 g/12g; g/12g 52257-1203_e8661940-0ebf-4d78-b43b-a9d4e5fe8276 52257-1203 HUMAN OTC DRUG ATOMY SUN SPF50 PLUS PA PLUS PLUS PLUS OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20100428 OTC MONOGRAPH FINAL part352 ATOMY CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 4.5; 3; 1.49; 2.88 mL/60mL; mL/60mL; mL/60mL; mL/60mL 52257-1204_9231064f-675b-4b73-9c4f-b1329bf81d3a 52257-1204 HUMAN OTC DRUG ATOMY SUN BEIGE SPF50 PLUS PA PLUS PLUS PLUS OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20100428 OTC MONOGRAPH FINAL part352 ATOMY CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 4.5; 3; 1.49; 2.94 mL/60mL; mL/60mL; mL/60mL; mL/60mL 52257-1205_525b39df-b72b-4c85-9b5e-892740605659 52257-1205 HUMAN OTC DRUG ATOMY MINERAL PACT SPF35 PA PLUS PLUS NO.25 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20100429 OTC MONOGRAPH FINAL part352 ATOMY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.2; .23 g/12g; g/12g 52257-1206_682caafa-9c60-4b07-8058-3132c1724e2c 52257-1206 HUMAN OTC DRUG ATOMY BB SPF30 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20100429 OTC MONOGRAPH FINAL part352 ATOMY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; 3.168; .768 mL/40mL; mL/40mL; mL/40mL 52257-1208_a47b5a6d-b4fc-41b4-ba7a-df0b33cadc05 52257-1208 HUMAN OTC DRUG PROPOLIS 50g SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20100525 OTC MONOGRAPH FINAL part355 ATOMY CO., LTD. SODIUM FLUORIDE; SODIUM MONOFLUOROPHOSPHATE .05; .08 g/50g; g/50g 52257-1209_be3364e4-db4f-40bc-8f48-f65723ec9f98 52257-1209 HUMAN OTC DRUG PROPOLIS 200g SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20100525 OTC MONOGRAPH FINAL part355 ATOMY CO., LTD. SODIUM FLUORIDE; SODIUM MONOFLUOROPHOSPHATE .2; .32 g/200g; g/200g 52257-1210_dbe504f6-c10f-4e78-bd96-ffadf7e4a12d 52257-1210 HUMAN OTC DRUG Atomy Sunscreen Beige SPF50 PLUS Octinoxate, Octisalate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 ATOMY CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 4.08; 2.7; 2.92; 8.06 mg/60mL; mg/60mL; mg/60mL; mg/60mL 52257-1220_70512bc8-79f3-4ac5-8218-171eb42a9ac3 52257-1220 HUMAN OTC DRUG Atomy Sunscreen White SPF50 PLUS Octinoxate, Octisalate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 ATOMY CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 4.08; 2.7; 2.92; 8.06 mg/60mL; mg/60mL; mg/60mL; mg/60mL 52257-1230_7f22847b-73a5-411a-a936-2d40186ec806 52257-1230 HUMAN OTC DRUG ATOMY SUNSCREEN BEIGE Broad Spectrum SPF50 Plus Octinoxate, Octisalate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 ATOMY CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 4.08; 2.7; 2.92; 8.06 mg/60mL; mg/60mL; mg/60mL; mg/60mL 52257-1240_f8cebb6d-a93e-4192-8b34-c6dde8608ba2 52257-1240 HUMAN OTC DRUG ATOMY SUNSCREEN WHITE Broad Spectrum SPF50 Plus Octinoxate, Octisalate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 ATOMY CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 4.08; 2.7; 2.92; 8.06 mg/60mL; mg/60mL; mg/60mL; mg/60mL 52257-1250_7cbc45a2-63b2-4d67-8093-0b78abe2d0c1 52257-1250 HUMAN OTC DRUG ATOMY BB BROAD SPECTRUM SPF30 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 ATOMY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.4; 3.16; .76 mg/40mL; mg/40mL; mg/40mL 52261-0200_20d83e39-88d8-4aff-8a57-3c5a7eec438f 52261-0200 HUMAN OTC DRUG Fiore Rx Pink Peppermint Pie Antifungal Nail Polish Undecylenic Acid FILM TOPICAL 20130423 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .45 g/15mL 52261-0201_f73e80ce-e1f9-4833-97f7-695adfb68860 52261-0201 HUMAN OTC DRUG Fiore Rx Antifungal Nail Lacquer Red Velvet Cake Undecylenic Acid FILM TOPICAL 20130520 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .45 g/15mL 52261-0202_c16568f2-cf08-4224-80c3-6ecc10d05215 52261-0202 HUMAN OTC DRUG Fiore Rx Almond Milk Matte Antifungal Nail Lacquer Undecylenic Acid FILM TOPICAL 20130521 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .45 g/15mL 52261-0203_6e3bcae5-e6bf-4455-ae30-8237138a2cc5 52261-0203 HUMAN OTC DRUG Fiore Rx Rock Candy Clear Antifungal Nail Lacquer Undecylenic Acid FILM TOPICAL 20130521 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .45 g/15mL 52261-0204_e472d4a8-1150-4b38-a370-83f4c0fdf5d5 52261-0204 HUMAN OTC DRUG Fiore Rx Pixie Dust Pink Antifungal Nail Polish Undecylenic Acid FILM TOPICAL 20130521 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .45 g/15mL 52261-0205_d8465c59-fa95-4c05-96db-a2eae66dc39c 52261-0205 HUMAN OTC DRUG Fiore Rx Eggplant My Garden Antifungal Nail Polish Undecylenic Acid FILM TOPICAL 20130521 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .45 g/15mL 52261-0206_1c2ca992-c050-4ea6-a849-e5746b3e7eae 52261-0206 HUMAN OTC DRUG Fiore Rx CranApple Crush Antifungal Nail Polish Undecylenic Acid FILM TOPICAL 20130522 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .45 g/15mL 52261-0207_3c3e09f1-2aa8-4bf7-b4dc-8af16d0e3759 52261-0207 HUMAN OTC DRUG Fiore Rx Coral Sorbet Antifungal Nail Polish Undecylenic Acid FILM TOPICAL 20130522 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .45 g/15mL 52261-2500_08c5d7fd-ce4a-43da-9972-127cef00fe89 52261-2500 HUMAN OTC DRUG Fiore Rx Antifungal ProPen Undecylenic Acid LIQUID TOPICAL 20130521 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .5 g/2g 52261-2501_62f5555c-0f35-4407-bc84-80d6e83c0d12 52261-2501 HUMAN OTC DRUG vbeaute Day Job 30ml zinc oxide LOTION TOPICAL 20130708 OTC MONOGRAPH FINAL part352 Cosco International, Inc. ZINC OXIDE 6.87 g/34.35g 52268-012_96cec13b-3fad-43f8-9e45-57de7ae7c5be 52268-012 HUMAN PRESCRIPTION DRUG SUPREP Bowel Prep sodium sulfate, potassium sulfate, magnesium sulfate SOLUTION, CONCENTRATE ORAL 20100806 NDA NDA022372 Braintree Laboratories, Inc. MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE 1.6; 3.13; 17.5 g/mL; g/mL; g/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 52268-100_062f0a59-731c-4c94-ae5c-620df9e6f7f2 52268-100 HUMAN PRESCRIPTION DRUG GoLYTELY Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride POWDER, FOR SOLUTION ORAL 19840713 NDA NDA019011 Braintree Laboratories, Inc. POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 236; 2.97; 6.74; 5.86; 22.74 g/4L; g/4L; g/4L; g/4L; g/4L Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 52268-101_062f0a59-731c-4c94-ae5c-620df9e6f7f2 52268-101 HUMAN PRESCRIPTION DRUG GoLYTELY Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride POWDER, FOR SOLUTION ORAL 19840713 NDA NDA019011 Braintree Laboratories, Inc. POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 236; 2.97; 6.74; 5.86; 22.74 g/4L; g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 52268-147_87be9429-978b-4660-be78-6e4a669932b9 52268-147 HUMAN PRESCRIPTION DRUG AXID nizatidine SOLUTION ORAL 20050630 NDA NDA021494 Braintree Laboratories, Inc. NIZATIDINE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 52268-400_f5c1fa80-77d3-445f-a748-663a86cee202 52268-400 HUMAN PRESCRIPTION DRUG NuLYTELY With Flavor Packs Polyethylene Glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride KIT ORAL 20070417 NDA NDA019797 Braintree Laboratories, Inc. 52268-523_a91a14d2-63cc-46d6-bde6-7a5289f3fbf4 52268-523 HUMAN PRESCRIPTION DRUG HalfLytely and Bisacodyl Bowel Prep with Flavor Packs PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride and bisacodyl KIT ORAL 20100802 NDA NDA021551 Braintree Laboratories, Inc. 52268-700_062f0a59-731c-4c94-ae5c-620df9e6f7f2 52268-700 HUMAN PRESCRIPTION DRUG GoLYTELY Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride POWDER, FOR SOLUTION ORAL 19840713 NDA NDA019011 Braintree Laboratories, Inc. POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 227.1; .754; 6.36; 5.53; 21.5 g/L; g/L; g/L; g/L; g/L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 52268-901_683f60c5-5d97-4794-9bfb-4743de2c9dec 52268-901 HUMAN PRESCRIPTION DRUG Suclear sodium sulfate, potassium sulfate, magnesium sulfate, polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride KIT ORAL 20130118 NDA NDA203595 Braintree Laboratories, Inc. 52270-001_ebccf5e2-7eeb-40d9-9491-7daf90e48d14 52270-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20140401 UNAPPROVED MEDICAL GAS Grant County Medical Equipment, LLC OXYGEN 1 L/L 52271-158_1f90ba87-1aa3-4099-996f-d0f8d0eb9193 52271-158 HUMAN OTC DRUG Vaporizing Chest Rub Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20090921 OTC MONOGRAPH FINAL part341 Quality Care Distributors LLC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 5.31; 1.13; 1.13 g/113g; g/113g; g/113g 52271-159_83734ee7-58a7-401b-b921-fab10197227a 52271-159 HUMAN OTC DRUG Hot Ice Soothing Analgesic Camphor and Menthol GEL TOPICAL 20090921 OTC MONOGRAPH FINAL part341 Quality Care Distributors LLC CAMPHOR (SYNTHETIC); MENTHOL 1.14; 2.27 g/227g; g/227g 52272-001_c38df570-c6b2-4320-8432-f0c97bb09d56 52272-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19830827 UNAPPROVED MEDICAL GAS Albright Welding & Supply Co Inc OXYGEN 990 mL/L 52276-312_b3038ffa-20c2-40f6-a302-c22511609079 52276-312 HUMAN PRESCRIPTION DRUG Carbaglu Carglumic Acid TABLET ORAL 20100318 NDA NDA022562 Orphan Europe, SARL CARGLUMIC ACID 200 mg/1 Carbamoyl Phosphate Synthetase 1 Activator [EPC],Carbamoyl Phosphate Synthetase 1 Activators [MoA] 52279-001_a7dc44b7-4fdd-496c-9c29-90a0afeef0ca 52279-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20021001 NDA NDA205767 Wesco gas & Welding Supply Inc OXYGEN 992 mL/L 52295-200_03218486-9b19-4ac2-ae39-6205a82183bf 52295-200 HUMAN OTC DRUG SPECIFIC BEAUTY DAILY HYDRATING SPF 30 AVOBENZONE,OCTOCRYLENE,OCTINOXATE,OXYBENZONE,OCTISALATE LOTION TOPICAL 20110120 OTC MONOGRAPH NOT FINAL part352 Somabella Laboratories, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 5; 5; 2.4; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 52295-207_1950041c-ed07-4ead-bbdf-7c4048efcfcf 52295-207 HUMAN OTC DRUG Specific Beauty Clarifying Wash Acne Treatment Cleanser SALICYLIC ACID SOAP TOPICAL 20110506 OTC MONOGRAPH FINAL part333D Somabella Laboratories, LLC SALICYLIC ACID 20 mg/mL 52301-365_4aa767e7-6691-406a-9906-4b40ba27d8e2 52301-365 HUMAN OTC DRUG Kool Comfort Menthol GEL TOPICAL 20120705 OTC MONOGRAPH NOT FINAL part348 Dee Cee Laboratories, Inc. MENTHOL 2.5 g/100g 52305-144_20a3714a-dfa1-4416-a5c7-46553401a6a5 52305-144 HUMAN OTC DRUG Trailways hand sanitizer Alcohol LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part341 Freshorize, Ltd. ALCOHOL 250 mL/295mL 52305-200_99c19d09-7127-414c-891d-e864c840a1a7 52305-200 HUMAN OTC DRUG Freshorize hand sanitizer Alcohol LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part333A Freshorize, Ltd. ALCOHOL 185 mL/295mL 52305-200_9ccaf1be-aacf-4d1b-a10d-a87498dfdf0d 52305-200 HUMAN OTC DRUG Freshorize hand sanitizer Alcohol LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part333A Freshorize, Ltd. ALCOHOL 185 mL/295mL 52305-300_26655249-257e-4763-bee6-1dcddb692925 52305-300 HUMAN OTC DRUG Freshorize Alcohol Free foaming hand sanitizer Benzalkonium Chloride LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part333A Freshorize, Ltd. BENZALKONIUM CHLORIDE .364 g/280mL 52305-400_bf032d5e-d855-4cf5-a3e5-c763d194e3e0 52305-400 HUMAN OTC DRUG Peter Pan Alcohol Free foaming hand sanitizer Benzalkonium Chloride LOTION TOPICAL 20110120 OTC MONOGRAPH NOT FINAL part333A Freshorize, Ltd. BENZALKONIUM CHLORIDE .364 g/280mL 52311-604_1b3776df-91e5-46b6-a07e-4d12d72db791 52311-604 HUMAN OTC DRUG Avalon Organics Essential Lift Sunscreen LOTION TOPICAL 20100501 OTC MONOGRAPH FINAL part352 Ironwood Clay Company, Inc. ZINC OXIDE 8.5 g/100g 52316-028_8ecf77c1-f102-4992-a08e-6f3d42a6036b 52316-028 HUMAN OTC DRUG Vortex Toothpaste PASTE, DENTIFRICE DENTAL 20111230 OTC MONOGRAPH FINAL part355 DSC Laboratories, Div. of DSC Products Inc. SODIUM FLUORIDE 2 mg/g 52316-190_f2608a38-5017-433d-a542-a667573dcd31 52316-190 HUMAN OTC DRUG Dinosaur Gel Toothpaste Toothpaste GEL, DENTIFRICE ORAL 19990719 OTC MONOGRAPH FINAL part355 DSC Laboratories, Div. of DSC Products Inc. SODIUM FLUORIDE 2.4 mg/g 52316-191_30d0497b-2eda-4b9f-9736-89ed3f60b795 52316-191 HUMAN OTC DRUG Shark Toothpaste Toothpaste PASTE, DENTIFRICE ORAL 19990719 OTC MONOGRAPH FINAL part355 DSC Laboratories, Div. of DSC Products Inc. SODIUM FLUORIDE 2.4 mg/g 52318-002_a9bb18f8-da78-40ae-a518-32bde345a1ba 52318-002 HUMAN OTC DRUG JOURNEE OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part352 Neocutis, Inc. OCTINOXATE; ZINC OXIDE 75; 73 mg/mL; mg/mL 52319-001_a4520022-5845-44a8-aa30-bab7729af0d0 52319-001 HUMAN OTC DRUG Sarene Soothing Skin Allantoin STICK TOPICAL 20100419 OTC MONOGRAPH FINAL part347 Beekley Corporation ALLANTOIN 5 mg/g 52322-002_a2cae1ea-ed87-4990-979b-eb8e763f061b 52322-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19671015 UNAPPROVED MEDICAL GAS Evergreen Supply Inc OXYGEN 995 mL/L 52327-011_050c6139-344c-47d4-e054-00144ff88e88 52327-011 HUMAN OTC DRUG EXTRA STRENGTH STOOL SOFTENER LAXATIVE DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20141020 OTC MONOGRAPH NOT FINAL part334 Aidapak Services, LLC DOCUSATE SODIUM 250 mg/250mg 52342-001_3d289299-692d-44c7-aca0-eef7b0adf28e 52342-001 HUMAN OTC DRUG Anti Chafe Balm Allantoin STICK TOPICAL 20100701 OTC MONOGRAPH FINAL part347 Hickory Brands Inc. ALLANTOIN 5 mg/g 52343-001_45d5d3f1-43e6-41e4-b2b4-51ba9085a526 52343-001 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Gen-Source Rx CEPHALEXIN 250 mg/1 52343-002_45d5d3f1-43e6-41e4-b2b4-51ba9085a526 52343-002 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Gen-Source Rx CEPHALEXIN 500 mg/1 52343-003_69e7980a-c5c8-4a28-a429-b0f2a0d638bc 52343-003 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Gen-Source Rx RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 52343-004_69e7980a-c5c8-4a28-a429-b0f2a0d638bc 52343-004 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Gen-Source Rx RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 52343-005_69e7980a-c5c8-4a28-a429-b0f2a0d638bc 52343-005 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Gen-Source Rx RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 52343-006_69e7980a-c5c8-4a28-a429-b0f2a0d638bc 52343-006 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Gen-Source Rx RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 52343-007_69e7980a-c5c8-4a28-a429-b0f2a0d638bc 52343-007 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Gen-Source Rx RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 52343-008_69e7980a-c5c8-4a28-a429-b0f2a0d638bc 52343-008 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Gen-Source Rx RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 52343-009_d70ff7d6-04a2-48a0-9a91-339674983142 52343-009 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Gen-Source Rx SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 52343-010_d70ff7d6-04a2-48a0-9a91-339674983142 52343-010 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Gen-Source Rx SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 52343-017_800d5103-dcf4-401e-bdfe-fde71b9216b9 52343-017 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20111201 ANDA ANDA090836 Gen-Source Rx CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52343-018_800d5103-dcf4-401e-bdfe-fde71b9216b9 52343-018 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20111201 ANDA ANDA090836 Gen-Source Rx CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52343-019_69e03c04-c878-446f-abdb-d8dec784a077 52343-019 HUMAN PRESCRIPTION DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED ORAL 20070611 ANDA ANDA065370 Gen-Source Rx CEFPODOXIME PROXETIL 100 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52343-020_69e03c04-c878-446f-abdb-d8dec784a077 52343-020 HUMAN PRESCRIPTION DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED ORAL 20070611 ANDA ANDA065370 Gen-Source Rx CEFPODOXIME PROXETIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52343-021_9a3d815e-ab40-4c1c-a065-281dac6685a6 52343-021 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Gen-Source Rx SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52343-022_9a3d815e-ab40-4c1c-a065-281dac6685a6 52343-022 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Gen-Source Rx SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52343-023_9a3d815e-ab40-4c1c-a065-281dac6685a6 52343-023 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Gen-Source Rx SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52343-024_9a3d815e-ab40-4c1c-a065-281dac6685a6 52343-024 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Gen-Source Rx SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52343-025_9a3d815e-ab40-4c1c-a065-281dac6685a6 52343-025 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Gen-Source Rx SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52343-026_106ff38f-526a-4993-9779-8399e8a0f765 52343-026 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Gen-Source Rx CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52343-027_106ff38f-526a-4993-9779-8399e8a0f765 52343-027 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Gen-Source Rx CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52343-028_106ff38f-526a-4993-9779-8399e8a0f765 52343-028 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Gen-Source Rx CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52343-029_106ff38f-526a-4993-9779-8399e8a0f765 52343-029 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Gen-Source Rx CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52343-030_531ad835-dbad-4252-ab61-561eb00a0359 52343-030 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Gen-Source Rx GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52343-031_531ad835-dbad-4252-ab61-561eb00a0359 52343-031 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Gen-Source Rx GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52343-032_531ad835-dbad-4252-ab61-561eb00a0359 52343-032 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Gen-Source Rx GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52343-037_2b385970-5ed2-44be-a86c-3eca2ca9df47 52343-037 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA202468 Gen-Source Rx MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 52343-038_13591d0b-0d4a-4bb4-bf49-d54ba5ca1759 52343-038 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20140926 ANDA ANDA202050 Gen-Source Rx OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 52343-039_13591d0b-0d4a-4bb4-bf49-d54ba5ca1759 52343-039 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20140926 ANDA ANDA202050 Gen-Source Rx OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 52343-040_13591d0b-0d4a-4bb4-bf49-d54ba5ca1759 52343-040 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20140926 ANDA ANDA202050 Gen-Source Rx OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 52343-041_13591d0b-0d4a-4bb4-bf49-d54ba5ca1759 52343-041 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20140926 ANDA ANDA202050 Gen-Source Rx OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 52343-042_13591d0b-0d4a-4bb4-bf49-d54ba5ca1759 52343-042 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20140926 ANDA ANDA202050 Gen-Source Rx OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 52343-043_13591d0b-0d4a-4bb4-bf49-d54ba5ca1759 52343-043 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20140926 ANDA ANDA202050 Gen-Source Rx OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 52343-044_54e21b7b-939c-4afa-9492-bde2b36dd352 52343-044 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine CAPSULE ORAL 20060327 ANDA ANDA078128 Gen-Source Rx ZIDOVUDINE 100 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 52343-045_c2dbe442-bd0c-40bf-be76-b18595676dc2 52343-045 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20050919 ANDA ANDA077267 Gen-Source Rx ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 52343-046_9fcbf4a1-ce26-4952-93f3-022c58a64dca 52343-046 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 20151218 ANDA ANDA065308 Gen-Source Rx CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52343-047_9fcbf4a1-ce26-4952-93f3-022c58a64dca 52343-047 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 20151223 ANDA ANDA065308 Gen-Source Rx CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52343-051_1cd5d77f-6478-4176-b703-6bfb3f5cb305 52343-051 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Gen-Source Rx VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 52343-052_1cd5d77f-6478-4176-b703-6bfb3f5cb305 52343-052 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Gen-Source Rx VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 52343-053_73e92590-87c0-4087-839e-d1aff2851a06 52343-053 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130213 ANDA ANDA200268 Gen-Source Rx PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 52343-054_73e92590-87c0-4087-839e-d1aff2851a06 52343-054 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130213 ANDA ANDA200268 Gen-Source Rx PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 52343-055_73e92590-87c0-4087-839e-d1aff2851a06 52343-055 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130213 ANDA ANDA200268 Gen-Source Rx PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 52343-059_2316d7c2-b49f-4ee2-bf59-e4058b4bfd89 52343-059 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Gen-Source Rx METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52343-060_2316d7c2-b49f-4ee2-bf59-e4058b4bfd89 52343-060 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Gen-Source Rx METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52343-061_2316d7c2-b49f-4ee2-bf59-e4058b4bfd89 52343-061 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Gen-Source Rx METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52343-062_2c884d84-8a0c-4d6e-b523-6006ceeef225 52343-062 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20060329 ANDA ANDA065308 Gen-Source Rx CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52343-063_2c884d84-8a0c-4d6e-b523-6006ceeef225 52343-063 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20060329 ANDA ANDA065308 Gen-Source Rx CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52343-067_162c1ada-fccf-4be8-b6e7-8fe470c10acf 52343-067 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 Gen-Source Rx CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52343-069_ed654864-5c4c-4299-b331-27666f895fa1 52343-069 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20141106 ANDA ANDA078993 Gen-Source Rx LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52343-070_ed654864-5c4c-4299-b331-27666f895fa1 52343-070 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20141106 ANDA ANDA078993 Gen-Source Rx LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52343-071_ed654864-5c4c-4299-b331-27666f895fa1 52343-071 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20141106 ANDA ANDA078993 Gen-Source Rx LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52343-072_ed654864-5c4c-4299-b331-27666f895fa1 52343-072 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20141106 ANDA ANDA078993 Gen-Source Rx LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52343-073_e1736d64-5950-4e68-8b68-ffb9bed88895 52343-073 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 Gen-Source Rx PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52343-074_e1736d64-5950-4e68-8b68-ffb9bed88895 52343-074 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 Gen-Source Rx PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52343-075_e1736d64-5950-4e68-8b68-ffb9bed88895 52343-075 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 Gen-Source Rx PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52343-076_e1736d64-5950-4e68-8b68-ffb9bed88895 52343-076 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 Gen-Source Rx PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52345-1001_5a571a00-50c0-4ce1-aca2-8e65d1046217 52345-1001 HUMAN OTC DRUG Dream Eye POLOXAMER 407 LIQUID OPHTHALMIC 20100617 UNAPPROVED DRUG OTHER K&J.C Co., Ltd POLOXAMER 407 .1 mL/mL 52345-2001_be14dd56-b21f-49ab-83e9-b3c1792422bf 52345-2001 HUMAN OTC DRUG Natural Care POLOXAMER 407 LIQUID OPHTHALMIC 20101005 UNAPPROVED DRUG OTHER K&J.C Co., Ltd POLOXAMER 407 .1 mL/mL 52345-3001_afdb9a19-6514-4467-b2b9-ff809dc565e7 52345-3001 HUMAN OTC DRUG Dream Eye POLOXAMER 407 LIQUID OPHTHALMIC 20101013 UNAPPROVED DRUG OTHER K&J.C Co., Ltd POLOXAMER 407 .1 mL/mL 52345-5001_a8526bd5-cba9-474e-8d43-e1fd74145911 52345-5001 HUMAN OTC DRUG NoSno XANTHAN GUM LIQUID NASAL 20120303 UNAPPROVED DRUG OTHER K&J.C Co., Ltd XANTHAN GUM .05 mL/44mL 52346-011_ef1b1d4d-8a28-4837-8804-581a35920a07 52346-011 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19851201 NDA NDA205866 Scott-Gross Company, Inc. NITROGEN 990 mL/L 52346-012_058a3de3-920b-4cac-bd2f-0e0b554d63c3 52346-012 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19741201 NDA NDA206009 Scott-Gross Company, Inc. NITROUS OXIDE 990 mL/L 52346-013_ce9e0b45-4043-458a-8730-c5ec80b145df 52346-013 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19771201 NDA NDA205865 Scott-Gross Company, Inc. OXYGEN 990 mL/L 52346-014_8bd51200-3985-4b9e-b9a4-039d1d31e147 52346-014 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20061101 NDA NDA205821 Scott-Gross Company, Inc. AIR 1000 mL/L 52346-015_c78cd9cd-3767-4472-be8d-9f3ed21b880c 52346-015 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20131017 NDA NDA205846 Scott-Gross Company, Inc. CARBON DIOXIDE 900 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 52347-111_4d08bcae-5846-41a6-8136-651da8e1c582 52347-111 HUMAN OTC DRUG Skin Care Prescription Avobenzone,Octocrylene,Oxybenzone,Homosalate,Octisalate LOTION TOPICAL 20100623 OTC MONOGRAPH FINAL part352 Skin Care Physicians, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.4; 17.01; .05; 4.54; .06 g/114.4g; g/113.4g; g/113.4g; g/113.4g; g/113.4g 52358-0001_6aeee696-a300-4e6f-b5f1-8096bb8841c4 52358-0001 HUMAN OTC DRUG Baby Butz Zinc Oxide CREAM TOPICAL 20130715 OTC MONOGRAPH FINAL part347 Olen Cosmetics Corporation ZINC OXIDE 17.1 g/57g 52358-0002_b85b30e4-3ce1-47b1-b240-fe323994f861 52358-0002 HUMAN OTC DRUG SUPRADERM white petrolatum, lanolin CREAM TOPICAL 20141017 OTC MONOGRAPH FINAL part347 Olen Cosmetics Corporation LANOLIN; PETROLATUM .15; .3 g/g; g/g 52371-100_6355d2b7-e075-4c82-9ff2-a40ca9cfbc01 52371-100 HUMAN OTC DRUG Bio-Active Anti-Aging AVOBENZONE, OCTINOXATE CREAM TOPICAL 20100622 OTC MONOGRAPH FINAL part352 S.I.P.R.E.S. SRL AVOBENZONE; OCTINOXATE 3; 7.5 g/100g; g/100g 52371-200_1ed4517c-92f5-4938-ac2d-fa7fa1de032d 52371-200 HUMAN OTC DRUG Biodynamic Skin AVOBENZONE, OCTINOXATE SOLUTION TOPICAL 20100622 OTC MONOGRAPH FINAL part352 S.I.P.R.E.S. SRL AVOBENZONE; OCTINOXATE 3; 7.5 mL/100mL; mL/100mL 52374-001_dc1e81e6-6c90-8ed5-9a52-02e7df65a332 52374-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19901119 UNAPPROVED MEDICAL GAS Linde Gas Puerto Rico, Inc OXYGEN 99 L/100L 52374-002_158ba5a0-57cb-5ffe-97dd-4c5430041368 52374-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19901127 UNAPPROVED MEDICAL GAS Linde Gas Puerto Rico, Inc NITROGEN 99 L/100L 52374-011_bf55a61e-7984-6fd2-c0e4-74c51af4f7a1 52374-011 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Linde Gas Puerto Rico, Inc OXYGEN 995 mL/L 52374-016_9b2168ba-826a-adc2-f0b9-c9d18e987332 52374-016 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Linde Gas Puerto Rico, Inc NITROGEN 995 mL/L 52374-101_1118251e-1dc0-b9ae-2627-1081f7533a12 52374-101 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19860616 NDA NDA205818 Linde Gas Puerto Rico, Inc OXYGEN 99 L/100L 52374-102_6878f4ec-02c0-7164-ab90-c21b1b19bfdb 52374-102 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19860801 NDA NDA205816 Linde Gas Puerto Rico, Inc NITROGEN 99 L/100L 52376-021_2c9c181a-58ff-4650-8aa2-6e73179ed476 52376-021 HUMAN PRESCRIPTION DRUG PAROEX Chlorhexidine Gluconate RINSE ORAL 20141031 ANDA ANDA076434 Sunstar Americas, Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] 52376-035_793f88ca-38a4-4aa0-bc2e-974f35e16b04 52376-035 HUMAN OTC DRUG Crayola SQUEEZE-A-COLOR Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130703 OTC MONOGRAPH FINAL part355 Sunstar Americas, Inc. SODIUM FLUORIDE .24 mg/g 52376-036_bf287eab-3685-4e35-8568-a32bc18370ea 52376-036 HUMAN OTC DRUG Gum Sodium Fluoride PASTE, DENTIFRICE DENTAL 20131201 OTC MONOGRAPH FINAL part355 Sunstar Americas, Inc. SODIUM FLUORIDE .24 g/100g 52376-040_48456712-a74b-46bf-8e08-30c2a31f2793 52376-040 HUMAN OTC DRUG Equitance Sunscreen Broad Spectrum SPF 36 Octinoxate Zinc Oxide LOTION TOPICAL 20140604 OTC MONOGRAPH FINAL part352 Sunstar Americas, Inc OCTINOXATE; ZINC OXIDE 6.5; 16.88 g/100mL; g/100mL 52380-0001_6b7041cc-f356-4731-9b98-7230f0ea5130 52380-0001 HUMAN OTC DRUG Aplicare Povidone Iodine Swabstick POVIDONE-IODINE SOLUTION TOPICAL 19840301 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 9.8 mg/mL 52380-0005_32e54b08-576d-478e-8324-084247124d1b 52380-0005 HUMAN OTC DRUG Aplicare Isopropyl Alcohol Isopropyl Alcohol SOLUTION TOPICAL 19850101 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 52380-0013_58120b6c-7e5b-49ff-9e26-a912357366d1 52380-0013 HUMAN OTC DRUG Aplicare Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 19831201 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. HYDROGEN PEROXIDE 3 mL/100mL 52380-0024_6e61bf62-5508-47db-812b-159facf6f1ac 52380-0024 HUMAN OTC DRUG Aplicare Povidone-Iodine Scrub Sponges Povidone-iodine Scrub Sponges SOLUTION TOPICAL 19920701 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 9.7 g/100g 52380-0025_dc616e0d-2478-41ed-b70c-3250039352b4 52380-0025 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Povidone-iodine SOLUTION TOPICAL 19840101 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 8.1 g/100g 52380-0026_ef94e673-daba-4bc0-ae0c-56c46ded5d9d 52380-0026 HUMAN OTC DRUG Aplicare Povidone-Iodine Povidone-Iodine Ointment OINTMENT TOPICAL 19840701 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 10.9 g/100g 52380-0038_4087a9ab-a928-4d7e-bcbd-0a31b3bb9c3d 52380-0038 HUMAN OTC DRUG Aplicare Povidone Iodine Swabstick Povidone Iodine GEL TOPICAL 20030601 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 10 g/100g 52380-0039_4f77b387-b064-4d15-a0ac-76e77c10e756 52380-0039 HUMAN OTC DRUG Aplicare ExCel AP Povidone-iodine Alcohol SOLUTION TOPICAL 20040601 OTC MONOGRAPH NOT FINAL part333A Aplicare ISOPROPYL ALCOHOL; POVIDONE-IODINE 507; 77.31 mg/mL; mg/mL 52380-0101_4a68b199-f8ec-4144-bccd-b24db05377f4 52380-0101 HUMAN OTC DRUG Aplicare Povidone-Iodine Sponge Povidone-Iodine Sponge SOLUTION TOPICAL 19920301 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 9.8 g/100g 52380-0540_fcd4aef5-70b8-4889-ac0a-33977221c061 52380-0540 HUMAN OTC DRUG Aplicare Antiseptic Hand Rinse Ethanol GEL TOPICAL 20060801 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. ALCOHOL .62 mL/mL 52380-1101_b3b7bc4c-6a47-4a8c-942d-e959ce7340b6 52380-1101 HUMAN OTC DRUG Aplicare Povidone Iodine Swabstick POVIDONE-IODINE SOLUTION TOPICAL 19840101 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL 52380-1102_9fb000bc-8d10-4cd8-a320-1f3d66c863ca 52380-1102 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Triples Povidone-iodine SOLUTION TOPICAL 19840101 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 8.1 g/100g 52380-1272_d0be6895-2ede-41aa-b39e-3380c61c8687 52380-1272 HUMAN OTC DRUG Aplicare Antiseptic Chlorhexidine Gluconate Chlorhexidine Gluconate SOLUTION TOPICAL 19980901 NDA NDA019125 Aplicare, Inc. CHLORHEXIDINE GLUCONATE 4 g/100g 52380-1274_f9bac287-2fea-404f-96e7-1c3dd8b8aac3 52380-1274 HUMAN OTC DRUG Aplicare Antiseptic Chlorhexidine Gluconate Chlorhexidine Gluconate SOLUTION TOPICAL 19980901 NDA NDA019422 Aplicare, Inc. CHLORHEXIDINE GLUCONATE 2 g/100g 52380-1614_3f02bcb8-cd7a-40fc-8bcf-492302cb1fea 52380-1614 HUMAN OTC DRUG Aplicare Antiseptic Hand Rinse Ethanol GEL TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. ALCOHOL 62 mL/100mL 52380-1617_c3e5f62f-6fe8-42eb-862b-de0536c30570 52380-1617 HUMAN OTC DRUG Aplicare Antiseptic Perineal Wash II Benzethonium Chloride SOLUTION TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. BENZETHONIUM CHLORIDE .2 1/100g 52380-1721_88c8640e-4318-4acc-ae5c-f76c281bfec2 52380-1721 HUMAN OTC DRUG Aplicare Povidone-iodine Povidone-iodine SOLUTION TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 g/100g 52380-1730_6780f5fe-51e5-4637-b049-389f557aadb9 52380-1730 HUMAN OTC DRUG Aplicare Povidone-iodine Povidone-iodine DOUCHE VAGINAL 19980901 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 10 g/100g 52380-1738_bee255a7-e148-43d1-9539-2681b035c46b 52380-1738 HUMAN OTC DRUG Aplicare Povidone Iodine Povidone Iodine GEL TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 10 g/100g 52380-1771_24dd38b6-9e89-4527-8702-d1d4fe81ed23 52380-1771 HUMAN OTC DRUG Aplicare Isopropyl Alcohol Isopropyl Alcohol GEL TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 52380-1845_76291767-ebfd-42aa-8316-8edc7c0f479c 52380-1845 HUMAN OTC DRUG Aplicare Physicians Antibacterial Triclosan LIQUID TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. TRICLOSAN .3 g/100g 52380-1855_a381be21-af69-4483-9eae-e899c65e40e0 52380-1855 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Povidone-iodine SOLUTION TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 8.1 g/100g 52380-1865_f09a3365-8cd6-4daf-9033-b5e6963e0d9e 52380-1865 HUMAN OTC DRUG Antibacterial Lotion Soap Triclosan LIQUID TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. TRICLOSAN .3 g/100g 52380-1880_580116d0-1677-4fcd-a188-cac8f00c1996 52380-1880 HUMAN OTC DRUG Aplicare Povidone-iodine Perineal Wash Povidone-iodine Perineal Wash LIQUID TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 10 1/100g 52380-1905_6424fbd1-d6bd-400d-9fc5-d683622d310b 52380-1905 HUMAN OTC DRUG Aplicare Povidone-Iodine Povidone-Iodine SOLUTION TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 9.8 g/100g 52380-2801_0663c29f-9e8e-4330-9dd1-a5f13ef94614 52380-2801 HUMAN OTC DRUG Aplicare Povidone-Iodine Povidone-Iodine SOLUTION TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 9.8 g/100g 52380-2802_c82f5661-77d7-4eb9-93e6-34124b17d6de 52380-2802 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Povidone-iodine SOLUTION TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 8.1 g/100g 52380-3101_8f3416fc-f8f5-4fdd-b7ca-23e5df3fc21c 52380-3101 HUMAN OTC DRUG Aplicare Povidone-iodine Triples Povidone-iodine SOLUTION TOPICAL 19980301 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL 52380-3102_4bd7b803-100a-4cb0-bb5c-768bc5f1e2ec 52380-3102 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Povidone-iodine SOLUTION TOPICAL 19840101 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 8.1 g/100g 52380-3191_d314c1ac-8b7a-4978-9c4c-936ddb17a84e 52380-3191 HUMAN OTC DRUG Curity Povidone-Iodine Paint Povidone-Iodine SOLUTION TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 9.5 g/mL 52380-4193_23aa7649-419e-4e68-a700-26cdc1557f16 52380-4193 HUMAN OTC DRUG Curity Povidone-Iodine One-Step Prep Povidone-Iodine GEL TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 9.7 g/mL 52380-4801_4ad436ec-3aa6-4410-9132-c75c19a15c6f 52380-4801 HUMAN OTC DRUG Aplicare Povidone-Iodine Povidone-Iodine SOLUTION TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 9.8 g/100g 52380-4802_2801b144-89a1-4fe9-9a4a-8df96b09b6a8 52380-4802 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Povidone-iodine SOLUTION TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 8.1 g/100g 52380-4892_a4748740-ce76-4211-8957-f3e87ada6345 52380-4892 HUMAN OTC DRUG Curity Povidone-Iodine Scrub Povidone-Iodine SOLUTION TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 7.86 g/mL 52380-7310_f097e630-cfad-47ce-bb53-3ec07c3d0943 52380-7310 HUMAN OTC DRUG Aplicare Total Joint Prep Povidone-iodine KIT TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. 52380-9957_7430a4e0-3952-4fe5-8a6b-dcd461fe6bcb 52380-9957 HUMAN OTC DRUG PCMX with Emollient Chloroxylenol SOLUTION TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. CHLOROXYLENOL 3.3 kg/100kg 52389-117_a495dd69-ce99-4c2e-8187-5e816c68092d 52389-117 HUMAN OTC DRUG Pep-Back Peak Performance Caffeine TABLET, FILM COATED ORAL 20070328 OTC MONOGRAPH FINAL part340 Alva-Amco Pharmacal Companies, Inc. CAFFEINE 200 mg/1 52389-118_c41a5f26-f050-4c31-9c69-1bb46bd611df 52389-118 HUMAN OTC DRUG Theradent Calcium acetate, potassium nitrate, potassium phosphate, sodium fluoride MOUTHWASH ORAL 20060717 UNAPPROVED HOMEOPATHIC Alva-Amco Pharmacal Companies, Inc. CALCIUM ACETATE; POTASSIUM NITRATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM FLUORIDE 1; 6; 1; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52389-126_d19348b7-2756-4cec-9502-8f1ff6b139d5 52389-126 HUMAN OTC DRUG Fungicure for Jock Itch Sepia SOAP TOPICAL 20060423 UNAPPROVED HOMEOPATHIC Alva-Amco Pharmacal Companies, Inc. SEPIA OFFICINALIS JUICE 12 [hp_X]/mL 52389-136_5553c6cd-f7f5-4405-b5b1-2773e71fbb43 52389-136 HUMAN OTC DRUG Diurex Pamabrom CAPSULE, LIQUID FILLED ORAL 20000410 OTC MONOGRAPH NOT FINAL part357 Alva-Amco Pharmacal Companies, Inc. PAMABROM 50 mg/1 52389-153_fd5c1030-6e78-44e5-9dcb-7416d507d1d7 52389-153 HUMAN OTC DRUG BackAid Max acetaminophen, pamabrom TABLET, FILM COATED ORAL 19920201 OTC MONOGRAPH NOT FINAL part343 Alva-Amco Pharmacal Companies, Inc. ACETAMINOPHEN; PAMABROM 500; 25 mg/1; mg/1 52389-154_a8a46c50-1eb6-4173-843f-fde86336c9bf 52389-154 HUMAN OTC DRUG Pep-Back Ultra Caffeine TABLET, FILM COATED ORAL 19930408 OTC MONOGRAPH FINAL part340 Alva-Amco Pharmacal Companies, Inc. CAFFEINE 200 mg/1 52389-155_bb908790-56ce-4543-aa20-e8ae48bfa93e 52389-155 HUMAN OTC DRUG Diurex Ultra Caffeine TABLET, FILM COATED ORAL 20050901 OTC MONOGRAPH NOT FINAL part357 Alva-Amco Pharmacal Companies, Inc. CAFFEINE 100 mg/1 52389-160_ff220f26-07a9-4828-ac94-17a75362f341 52389-160 HUMAN OTC DRUG Fungicure Manicure Pedicure Clotrimazole LIQUID TOPICAL 20020715 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. CLOTRIMAZOLE 10 mg/mL 52389-161_919bfa4c-d186-45ce-8995-a45086436221 52389-161 HUMAN OTC DRUG Fungicure Ultra Original Formula Undecylenic acid LIQUID TOPICAL 19950101 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. UNDECYLENIC ACID 100 mg/mL 52389-162_81611424-a7d6-4a12-af30-f1877caa60c7 52389-162 HUMAN OTC DRUG Fungicure Tolnaftate GEL TOPICAL 19941001 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. TOLNAFTATE 10 mg/g 52389-166_8851d133-7460-4c02-b972-7fe6db19c181 52389-166 HUMAN OTC DRUG Psoriasin Gel Coal Tar Topical Gel GEL TOPICAL 19960218 OTC MONOGRAPH FINAL part358H Alva-Amco Pharmacal Companies, Inc. COAL TAR 12.5 mg/g 52389-168_6e6c0678-0385-493d-baa6-b598f7535ab7 52389-168 HUMAN OTC DRUG Fungicure Professional Formula Undecylenic Acid LIQUID TOPICAL 20050127 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. UNDECYLENIC ACID 125 mg/mL 52389-169_e884fcee-5844-4e53-bb71-92485743cffc 52389-169 HUMAN OTC DRUG Psoriasin Coal Tar LIQUID TOPICAL 20020120 OTC MONOGRAPH FINAL part358 Alva-Amco Pharmacal Companies, Inc. COAL TAR 6.6 mg/mL 52389-171_a7138a76-0ec2-453c-9404-af6b8f4f1b5a 52389-171 HUMAN OTC DRUG Psoriasin Therapeutic Shampoo and Body Wash Salicylic acid SHAMPOO TOPICAL 19990228 OTC MONOGRAPH FINAL part358 Alva-Amco Pharmacal Companies, Inc. SALICYLIC ACID 3 g/100g 52389-172_b35b5e0f-9b2e-40ae-9db7-65f245e40844 52389-172 HUMAN OTC DRUG Nauzene Sodium Citrate SYRUP ORAL 20000215 OTC MONOGRAPH NOT FINAL part357 Alva-Amco Pharmacal Companies, Inc. DEXTROSE; FRUCTOSE; TRISODIUM CITRATE DIHYDRATE 4.35; 4.17; .921 g/15mL; g/15mL; g/15mL 52389-173_b67eb1da-8294-44ef-8081-63fe44b8503c 52389-173 HUMAN OTC DRUG Prosacea Sulphur GEL TOPICAL 20060206 UNAPPROVED HOMEOPATHIC Alva-Amco Pharmacal Companies, Inc. SULFUR 1 [hp_X]/g 52389-178_ee1cac18-384e-4568-8672-64c39c777784 52389-178 HUMAN OTC DRUG Psoriasin Coal Tar OINTMENT TOPICAL 20040601 OTC MONOGRAPH FINAL part358 Alva-Amco Pharmacal Companies, Inc. COAL TAR 20 mg/g 52389-179_45a475d4-a736-4afe-a06f-a5a8fa02c0ac 52389-179 HUMAN OTC DRUG Herpetrol Benzalkonium chloride, menthol, petrolatum OINTMENT TOPICAL 20050630 OTC MONOGRAPH FINAL part348 Alva-Amco Pharmacal Companies, Inc. BENZALKONIUM CHLORIDE; MENTHOL; PETROLATUM 1.3; 10; 970 mg/g; mg/g; mg/g 52389-198_e1986b31-3c38-48e9-a5f2-ced46228ce90 52389-198 HUMAN OTC DRUG Fungicure Maximum Strength Undecylenic Acid LIQUID TOPICAL 20050127 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. UNDECYLENIC ACID 250 mg/mL 52389-237_1ddb6099-bcf5-46d8-aae0-c08f688100d7 52389-237 HUMAN OTC DRUG Arthriten Inflammatory Pain Formula acetaminophen, aspirin, caffeine TABLET, FILM COATED ORAL 20120723 OTC MONOGRAPH NOT FINAL part343 Alva-Amco Pharmacal Companies, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 52389-241_c5d9bbdf-fb2d-4654-9945-ae99c9528ddd 52389-241 HUMAN OTC DRUG Uricalm Maximum Strength Phenazopyridine Hydochloride TABLET, FILM COATED ORAL 20080429 UNAPPROVED DRUG OTHER Alva-Amco Pharmacal Companies, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg/1 52389-242_9a627c00-3591-4633-b678-31e6ce805b80 52389-242 HUMAN OTC DRUG Nauzene Sodium Citrate TABLET, CHEWABLE ORAL 20000708 UNAPPROVED DRUG OTHER Alva-Amco Pharmacal Companies, Inc. TRISODIUM CITRATE DIHYDRATE 230 mg/1 52389-249_6ff153a1-aff6-4ea3-9945-f0d1ec8fea9d 52389-249 HUMAN OTC DRUG Diurex Max Pamabrom TABLET, FILM COATED ORAL 19951220 OTC MONOGRAPH NOT FINAL part357 Alva-Amco Pharmacal Companies, Inc. PAMABROM 50 mg/1 52389-263_7171e9e6-f2a0-4b32-92b8-400447de241d 52389-263 HUMAN OTC DRUG Fungicure Pumpspray Clotrimazole LIQUID TOPICAL 20020301 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. CLOTRIMAZOLE 10 mg/mL 52389-266_f26876dc-c0ab-4a3f-bfa4-d50b361eeb30 52389-266 HUMAN OTC DRUG Psoriasin Coal Tar GEL TOPICAL 19960218 OTC MONOGRAPH FINAL part358H Alva-Amco Pharmacal Companies, Inc. COAL TAR 12.5 mg/g 52389-306_6ed33c8b-f52c-44b1-86dc-cc59f07c3b41 52389-306 HUMAN OTC DRUG Diurex Water Pills Caffeine, magnesium salicylate TABLET, COATED ORAL 20050515 OTC MONOGRAPH NOT FINAL part343 Alva-Amco Pharmacal Companies, Inc. CAFFEINE; MAGNESIUM SALICYLATE 50; 162.5 mg/1; mg/1 52389-325_af12beff-d5c5-495b-910e-fb88915e89e4 52389-325 HUMAN OTC DRUG Diurex Pamabrom CAPSULE ORAL 20050401 OTC MONOGRAPH NOT FINAL part357 Alva-Amco Pharmacal Companies, Inc. PAMABROM 50 mg/1 52389-600_2c889a34-c50d-4561-b857-2f04ade6472e 52389-600 HUMAN OTC DRUG Fungicure Intensive Clotrimazole LIQUID TOPICAL 20080605 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. CLOTRIMAZOLE 10 mg/mL 52389-606_09c1c792-a69b-4165-bb76-ca9f04b18c08 52389-606 HUMAN OTC DRUG Acnevir Facial Wash Salicylic Acid SOAP TOPICAL 20091201 OTC MONOGRAPH FINAL part333D Alva-Amco Pharmacal Companies, Inc. SALICYLIC ACID 2 g/100g 52389-608_fe881432-18bc-438c-993b-d5024af34aa8 52389-608 HUMAN OTC DRUG AcneVir Sulphur, resorcinol, salicylic acid GEL TOPICAL 20091201 UNAPPROVED HOMEOPATHIC Alva-Amco Pharmacal Companies, Inc. RESORCINOL; SALICYLIC ACID; SULFUR 2; 3; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g 52389-610_ab6524fe-005d-4d4b-abd0-10c7f2d062e8 52389-610 HUMAN OTC DRUG Tranquil Nighttime Diphenhydramine Hydrochloride TABLET ORAL 20100830 OTC MONOGRAPH FINAL part338 Alva-Amco Pharmacal Companies, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 52389-612_a66d47e3-6449-488c-956b-e2247e76b2d4 52389-612 HUMAN OTC DRUG Nauzene Motion Bryonia alba root, sepia TABLET, COATED ORAL 20110915 UNAPPROVED HOMEOPATHIC Alva-Amco Pharmacal Companies, Inc. BRYONIA ALBA ROOT; SEPIA OFFICINALIS JUICE 3; 12 [hp_X]/1; [hp_X]/1 52389-613_992f7ac1-ecda-4bd2-863e-9630c9c77f19 52389-613 HUMAN OTC DRUG Diurex WaterCaps Caffeine TABLET, FILM COATED ORAL 20090415 OTC MONOGRAPH NOT FINAL part357 Alva-Amco Pharmacal Companies, Inc. CAFFEINE 200 mg/1 52389-621_a81b6491-8092-44b7-b7b4-f66f3543e75f 52389-621 HUMAN OTC DRUG Nauzene Homeopathic Lactic acid, wild hops LIQUID ORAL 20140408 UNAPPROVED HOMEOPATHIC Alva-Amco Pharmacal Companies, Inc. BRYONIA ALBA ROOT; LACTIC ACID 3; 3 [hp_X]/15mL; [hp_X]/15mL 52389-622_b1dc7b4d-ef8d-4d00-90f1-107eb34e4fc5 52389-622 HUMAN OTC DRUG BackAid Inflammatory Pain Formula acetaminophen, aspirin, caffeine TABLET, FILM COATED ORAL 20121022 OTC MONOGRAPH NOT FINAL part343 Alva-Amco Pharmacal Companies, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 52389-623_d83a2f05-31bd-4ca9-be49-3953df23d861 52389-623 HUMAN OTC DRUG Verticalm Meclizine Hydrochloride TABLET ORAL 20120416 OTC MONOGRAPH FINAL part336 Alva-Amco Pharmacal Companies, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 52389-627_7ee39721-9642-428f-9cd1-30f9a532cc53 52389-627 HUMAN OTC DRUG Psoriasin Medicated Wash Salicylic acid SOAP TOPICAL 20110102 OTC MONOGRAPH FINAL part358H Alva-Amco Pharmacal Companies, Inc. SALICYLIC ACID 3 g/100g 52389-628_39075e22-6df7-48b1-9aa8-2aef6cde31e8 52389-628 HUMAN OTC DRUG Eczemin Pramoxine Hydrochloride CREAM TOPICAL 20111116 OTC MONOGRAPH NOT FINAL part348 Alva-Amco Pharmacal Companies, Inc. PRAMOXINE HYDROCHLORIDE 10 mg/g 52389-633_25c7a36c-6f2d-41c4-b357-1e3421974e8b 52389-633 HUMAN OTC DRUG Fungicure Maximum Strength Undecylenic Acid GEL TOPICAL 20121130 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. UNDECYLENIC ACID 250 mg/g 52389-638_99955b20-ec50-4524-8746-7a94f7e73ac3 52389-638 HUMAN OTC DRUG Lysimax Benzalkonium chloride, menthol, petrolatum OINTMENT TOPICAL 20130904 OTC MONOGRAPH NOT FINAL part348 Alva-Amco Pharmacal Companies, Inc. BENZALKONIUM CHLORIDE; MENTHOL; PETROLATUM 1.3; 10; 970 mg/g; mg/g; mg/g 52389-639_dcbbc99c-e3f1-4957-8e34-3d4be3385d84 52389-639 HUMAN OTC DRUG Fungicure Athletes Foot Tolnaftate 1% CREAM TOPICAL 20140326 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc TOLNAFTATE 10 mg/g 52389-642_f474c04d-75fb-47f7-880a-9e68b676d114 52389-642 HUMAN OTC DRUG Uricalm Intensive acetaminophen, aspirin, caffeine TABLET, FILM COATED ORAL 20130923 OTC MONOGRAPH NOT FINAL part343 Alva-Amco Pharmacal Companies, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 52389-729_4be5cebb-cc19-4014-8e9e-9f2d71179af1 52389-729 HUMAN OTC DRUG Nauzene Grape Sodium Citrate SYRUP ORAL 20120424 UNAPPROVED DRUG OTHER Alva-Amco Pharmacal Companies, Inc. TRISODIUM CITRATE DIHYDRATE .921 g/15mL 52410-3020_ffb7e856-80d0-4627-b4db-e82f49fd166e 52410-3020 HUMAN OTC DRUG Medpride White Petrolatum OINTMENT TOPICAL 20130523 OTC MONOGRAPH FINAL part347 Shield Line LLC PETROLATUM 100 g/100g 52410-3025_c93ea21e-cdba-49ed-8ffb-6be44c9c61d3 52410-3025 HUMAN OTC DRUG Medpride First Aid Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate OINTMENT TOPICAL 20130517 OTC MONOGRAPH FINAL part333B Shield Line LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 52410-3035_950bbe17-987f-4828-ab74-bfb95145b7b6 52410-3035 HUMAN OTC DRUG Medpride First Aid Bacitracin Zinc OINTMENT TOPICAL 20130530 OTC MONOGRAPH FINAL part333B Shield Line LLC BACITRACIN ZINC 500 [USP'U]/g 52410-3040_4238ccef-607c-4ce3-a361-d2a50bbeaded 52410-3040 HUMAN OTC DRUG Medpride Zinc Oxide OINTMENT TOPICAL 20130523 OTC MONOGRAPH FINAL part347 Shield Line LLC ZINC OXIDE 20 g/100g 52410-3045_2b513f8d-c7d4-4ae4-9b5f-ea00687e61dd 52410-3045 HUMAN OTC DRUG Medpride Vitamin A and D White Petrolatum OINTMENT TOPICAL 20130523 OTC MONOGRAPH FINAL part347 Shield Line LLC PETROLATUM 76 g/100g 52410-3050_ac92e4a1-21cc-46e4-bf9b-52945216dc7d 52410-3050 HUMAN OTC DRUG MedPride Hydrocortisone CREAM TOPICAL 20130523 OTC MONOGRAPH NOT FINAL part348 Shield Line LLC HYDROCORTISONE ACETATE 10 mg/g 52410-3060_0c340877-7f98-4eaa-a78c-3acce9fa95fd 52410-3060 HUMAN OTC DRUG Medpride EN SHIELD ALOE SOFT VITAMIN ENRICHED ZINC OXIDE CREAM TOPICAL 20130527 OTC MONOGRAPH FINAL part347 Shield Line LLC ZINC OXIDE 1.8 g/100g 52410-3065_b1d4b6a3-7484-4674-9598-42cd3a12358c 52410-3065 HUMAN OTC DRUG Medpride En Shield ZINC OXIDE DIMETHICONE CREAM TOPICAL 20130527 OTC MONOGRAPH FINAL part347 Shield Line LLC DIMETHICONE; ZINC OXIDE 1.8; 1.8 g/100g; g/100g 52410-3066_09ca05e1-b9c6-459c-b3ac-816a108d10dc 52410-3066 HUMAN OTC DRUG Medpride EN SHIELD ALOE SOFT VITAMIN ENRICHED ZINC OXIDE CREAM TOPICAL 20130527 OTC MONOGRAPH FINAL part347 Shield Line LLC ZINC OXIDE 3.8 g/100g 52410-4110_5793ed15-aaa0-4266-bb29-873c9048a54d 52410-4110 HUMAN OTC DRUG MedPride Sterile Prep Pads Isopropyl Alcohol CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Shield Line LLC ISOPROPYL ALCOHOL .7 g/1 52410-4150_bbd5cebd-8de1-4b37-90f7-211033d92a2a 52410-4150 HUMAN OTC DRUG MedPride Sterile Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Shield Line LLC BENZALKONIUM CHLORIDE .133 g/1 52410-6135_9a965bdc-7f93-4981-9469-22f6d6524eab 52410-6135 HUMAN OTC DRUG MedPride Lemon Glycerin SWAB ORAL 20140501 OTC MONOGRAPH NOT FINAL part356 Shield Line LLC GLYCERIN .075 g/1 52410-6138_2779958a-18ea-44b6-b21a-91419376c856 52410-6138 HUMAN OTC DRUG MedPride Isopropyl Alcohol SWAB TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part333A Shield Line LLC ISOPROPYL ALCOHOL .7 mL/1 52410-6141_7c35f1b9-f909-4672-b7b6-5b2bfbcce8dc 52410-6141 HUMAN OTC DRUG MedPride Swabsticks Povidone Iodine SOLUTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part333A Shield Line LLC POVIDONE-IODINE .1 g/1 52410-8036_04524f9e-be0b-4cf5-8e95-0bfe9f1c6074 52410-8036 HUMAN OTC DRUG AmeriDerm Vitamin A D White Petrolatum OINTMENT TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Shield Line LLC PETROLATUM 76 g/100g 52410-9005_e2b01b92-3c12-46d9-b6e3-46542f670c8a 52410-9005 HUMAN OTC DRUG Medpride Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20130527 OTC MONOGRAPH FINAL part355 Shield Line LLC SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 52424-0001_f94a641a-9896-4353-ac91-6c01e65a4baf 52424-0001 HUMAN OTC DRUG BIO BEAUTY BIO DEFENSE TINTED FOUNDATION SPF 18 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100620 OTC MONOGRAPH NOT FINAL part352 LIBINVEST OCTINOXATE; TITANIUM DIOXIDE 7.5; 8 g/100mL; g/100mL 52424-0002_f94a641a-9896-4353-ac91-6c01e65a4baf 52424-0002 HUMAN OTC DRUG BIO BEAUTY BIO DEFENSE TINTED FOUNDATION SPF 18 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100620 OTC MONOGRAPH NOT FINAL part352 LIBINVEST OCTINOXATE; TITANIUM DIOXIDE 7.5; 8 g/100mL; g/100mL 52426-020_6d037501-669e-491c-99ff-6452e2753391 52426-020 HUMAN OTC DRUG Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 20100923 OTC MONOGRAPH FINAL part333B Phoenix Global Supply Group, Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 52426-120_b0f4a5d9-9d8a-4f62-ba9d-3d383989323a 52426-120 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20100923 OTC MONOGRAPH FINAL part333B Phoenix Global Supply Group, Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g 52426-220_5328de28-f628-4f1c-b03e-03ad9a98c796 52426-220 HUMAN OTC DRUG Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20100923 OTC MONOGRAPH FINAL part333B Phoenix Global Supply Group, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g 52426-220_ad7a427d-3ad0-4a47-8e2f-223b9242bd90 52426-220 HUMAN OTC DRUG ANTIBIOTIC PLUS PAIN RELIEF Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part333B Phoenix Global Supply Group, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g 52426-320_fb4d1f7b-1818-4155-978b-fc7bd5865eac 52426-320 HUMAN OTC DRUG Bacitracin Bacitracin zinc OINTMENT TOPICAL 20110401 OTC MONOGRAPH FINAL part333B Phoenix Global Supply Group, Inc BACITRACIN ZINC 500 [iU]/g 52426-420_4a970118-6a7f-4fa1-b822-442a96d20f5b 52426-420 HUMAN OTC DRUG Poly Bacitracin Bacitracin zinc and Polymyxin B sulfate OINTMENT TOPICAL 20100923 OTC MONOGRAPH FINAL part333B Phoenix Global Supply Group, Inc BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [iU]/g; [iU]/g 52426-520_adee22b6-9680-45c2-87c5-332424f62cbb 52426-520 HUMAN OTC DRUG Myxcin-C Hexylresorcinol SOLUTION TOPICAL 20110215 OTC MONOGRAPH NOT FINAL part333A Phoenix Global Supply Group, Inc. HEXYLRESORCINOL 1.1 mg/mL 52427-272_ad28dcef-70a1-9000-3f8c-e0d3f4e1a7f1 52427-272 HUMAN PRESCRIPTION DRUG Naprelan Naproxen Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140117 NDA NDA020353 ALMATICA PHARMA INC. NAPROXEN SODIUM 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52427-273_ad28dcef-70a1-9000-3f8c-e0d3f4e1a7f1 52427-273 HUMAN PRESCRIPTION DRUG Naprelan Naproxen Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140117 NDA NDA020353 ALMATICA PHARMA INC. NAPROXEN SODIUM 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52427-274_ad28dcef-70a1-9000-3f8c-e0d3f4e1a7f1 52427-274 HUMAN PRESCRIPTION DRUG Naprelan Naproxen Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140117 NDA NDA020353 ALMATICA PHARMA INC. NAPROXEN SODIUM 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52427-285_039c8f9c-f410-a898-e101-b8eac83f2d97 52427-285 HUMAN PRESCRIPTION DRUG Macrobid Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110531 NDA NDA020064 Almatica Pharma Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 52427-286_54e6a03c-8b46-d0c4-d89c-8fc140df29ff 52427-286 HUMAN PRESCRIPTION DRUG Macrodantin Nitrofurantion crystals Macrodantin CAPSULE ORAL 20100927 NDA NDA016620 Almatica Pharma Inc. NITROFURANTOIN 25 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 52427-287_54e6a03c-8b46-d0c4-d89c-8fc140df29ff 52427-287 HUMAN PRESCRIPTION DRUG Macrodantin Nitrofurantion crystals Macrodantin CAPSULE ORAL 20100927 NDA NDA016620 Almatica Pharma Inc. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 52427-288_54e6a03c-8b46-d0c4-d89c-8fc140df29ff 52427-288 HUMAN PRESCRIPTION DRUG Macrodantin Nitrofurantion crystals Macrodantin CAPSULE ORAL 20100927 NDA NDA016620 Almatica Pharma Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 52428-001_4e17c42c-6bb9-40e2-b2bd-04ab33852518 52428-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20100616 UNAPPROVED MEDICAL GAS Arkansas Home Medical OXYGEN 99 L/100L 52429-123_01df705a-5399-4014-a292-b3e922ba3dee 52429-123 HUMAN OTC DRUG NasalAsalt All-Natural Seawater Sodium Chloride SPRAY NASAL 20111101 OTC MONOGRAPH FINAL part349 Nasal and Sinus Health, Inc. SODIUM CHLORIDE 2600 mg/100mL 52429-124_42549b28-7afe-4f59-97fc-2dca2ff816bd 52429-124 HUMAN OTC DRUG Breathe the Sea All-Natural Seawater Sodium Chloride SPRAY NASAL 20120301 UNAPPROVED DRUG OTHER Nasal and Sinus Health, Inc. SODIUM CHLORIDE 2600 mg/100mL 52438-011_45bf86e5-634d-9b81-d190-2179ad8a1573 52438-011 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205767 Linde LLC OXYGEN 995 mL/L 52438-014_d49b913f-46fe-5a73-dcca-afd4f09a5655 52438-014 HUMAN PRESCRIPTION DRUG Carbon Dioxide Refrigerated Carbon Dioxide GAS RESPIRATORY (INHALATION) 19650101 NDA NDA205764 Linde LLC CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 52438-016_ac0e6fb7-06c1-1ce3-d285-7fe218e1f38d 52438-016 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205766 Linde LLC NITROGEN 995 mL/L 52456-018_05a1089e-1936-4921-a7df-4beffe53f454 52456-018 HUMAN OTC DRUG GLAMTOX ACTIVE DAILY MOISTURIZING SUNSCREEN HOMOSALATE, OCTINOXATE, OXYBENZONE LIQUID TOPICAL 20100630 OTC MONOGRAPH FINAL part352 Rodial, Ltd. HOMOSALATE; OCTINOXATE; OXYBENZONE 3; 8; 2 mL/100mL; mL/100mL; mL/100mL 52460-000_e243b182-926c-46f5-9dfe-351eaf96e719 52460-000 HUMAN OTC DRUG Business Elite Amenity ALCOHOL, SODIUM FLUORIDE KIT 20120830 OTC MONOGRAPH FINAL part333E Hangzhou Zhuwen Inflight & Travel Products Co., Ltd. 52460-003_9c96217e-2a8d-484b-bead-97e268ed092f 52460-003 HUMAN OTC DRUG Business Elite Amenity SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20120916 OTC MONOGRAPH FINAL part355 Hangzhou Zhuwen Inflight & Travel Products Co., Ltd. SODIUM FLUORIDE 2.43 mg/g 52471-100_44d74207-2e5b-47bd-87ac-aba45145fe40 52471-100 HUMAN OTC DRUG A and D plus E Petrolatum OINTMENT TOPICAL 20120514 OTC MONOGRAPH FINAL part347 H&H Laboratories, Inc. PETROLATUM 937.5 mg/g 52471-101_41f08daa-55b1-42ac-b2e2-4a8dd8883536 52471-101 HUMAN OTC DRUG A and D Petrolatum OINTMENT TOPICAL 20120514 OTC MONOGRAPH FINAL part347 H&H Laboratories, Inc. PETROLATUM 937.5 mg/g 52471-111_f251e7d4-222e-4e0f-9317-2e75bdaa86f2 52471-111 HUMAN OTC DRUG Sorbitol Sorbitol SOLUTION RECTAL 20130610 OTC MONOGRAPH NOT FINAL part334 H&H Laboratories, Inc. SORBITOL 1 g/mL 52471-116_c1a05a5a-85a2-491e-812c-7ea8411669cf 52471-116 HUMAN OTC DRUG Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20120503 OTC MONOGRAPH NOT FINAL part347 H&H Laboratories, Inc. ZINC OXIDE 200 mg/g 52472-100_62d5fef4-108c-4279-aec5-ac0606054c72 52472-100 HUMAN PRESCRIPTION DRUG Oxygen, Refrigerated OXYGEN GAS RESPIRATORY (INHALATION) 20100707 UNAPPROVED MEDICAL GAS Breath of Life LLC OXYGEN 1 L/L 52473-001_502d8daf-8b6f-4651-b0ae-08e205bcdf16 52473-001 HUMAN OTC DRUG Vanish Benzalkonium Chloride LIQUID TOPICAL 20100614 OTC MONOGRAPH NOT FINAL part333A Tinks BENZALKONIUM CHLORIDE .13 mL/100mL 52473-010_9aaae807-122b-465f-98e8-6f25cfaf74fc 52473-010 HUMAN OTC DRUG Odorless Hand Sanitizer Foam Benzalkonium Chloride LIQUID TOPICAL 20100515 OTC MONOGRAPH NOT FINAL part333A Tinks BENZALKONIUM CHLORIDE .1 mL/100mL 52481-2481_b7002709-f28f-41ae-8c9e-09acd845791d 52481-2481 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19770101 UNAPPROVED MEDICAL GAS Genesis Respiratory Services OXYGEN 99.9 L/100L 52486-000_eaed64ca-bf43-4732-8305-ab5143b9e237 52486-000 HUMAN OTC DRUG PARAID Alcohol ISOPROPYL ALCOHOL LIQUID TOPICAL 20120719 OTC MONOGRAPH NOT FINAL part333A MCURE HEALTH SOLUTIONS INC ISOPROPYL ALCOHOL 70 mL/100mL 52486-100_f6b07706-abfd-47d7-9767-118c06614397 52486-100 HUMAN OTC DRUG PARAID One Step Wart Remover Strips SALICYLIC ACID PLASTER TOPICAL 20140805 OTC MONOGRAPH FINAL part358B Mcure Health Solutions Inc SALICYLIC ACID .4 g/1 52490-100_4c98ea1a-2307-494b-b503-b2fee681bf49 52490-100 HUMAN OTC DRUG B4 Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part333A Midway Advanced Products, LLC ALCOHOL 42 mg/25mL 52490-100_d120f92e-5df5-4cde-a1ab-ff8c0eb77884 52490-100 HUMAN OTC DRUG B4 Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part333A Midway Advanced Products, LLC ALCOHOL 42 mg/25mL 52490-200_079c7c82-6400-432b-8bc4-bd2133baab07 52490-200 HUMAN OTC DRUG KNOCKOUT HAND SANITIZER Alcohol SOLUTION PERCUTANEOUS 20110801 OTC MONOGRAPH NOT FINAL part333E Midway Advanced Products, LLC ALCOHOL 42 mg/25mL 52512-130_1ce5f34a-abc9-4ea8-b654-407ecf954440 52512-130 HUMAN OTC DRUG Dr. Numb Lidocaine CREAM TOPICAL 20121115 OTC MONOGRAPH FINAL part348 Ei Inc. LIDOCAINE 5 g/100g 52512-161_794ec692-f58c-4efd-b341-9b86ae3449f8 52512-161 HUMAN OTC DRUG Cold-EEZE cherry Zinc Gluconate SPRAY TOPICAL 20110801 20190331 UNAPPROVED HOMEOPATHIC Ei Inc. ZINC GLUCONATE 2 [hp_X]/.5mL 52512-162_794ec692-f58c-4efd-b341-9b86ae3449f8 52512-162 HUMAN OTC DRUG Cold-EEZE mint Zinc Gluconate SPRAY TOPICAL 20110801 20190331 UNAPPROVED HOMEOPATHIC Ei Inc. ZINC GLUCONATE 2 [hp_X]/.5mL 52512-501_7ff2929c-7264-4fb1-bdcf-901a0f729fe6 52512-501 HUMAN OTC DRUG Dark Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Ei Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 20 g/100g; g/100g 52533-001_1e1fd364-492a-4be3-8e25-5891c549b820 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20111205 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52533-001_2a80c18a-119b-4df9-a9d2-b9bf8038d900 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20111205 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52533-001_40d556c4-7ec7-4ea9-b9ff-75690f63010f 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20120413 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52533-001_66bccb0f-6574-4cdb-8dc4-ecbb1d0eec0c 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20130628 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52533-001_84df0f0c-86b5-4444-a4e1-c09e31a9dda8 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20130408 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52533-001_a903817d-763b-4266-847a-dd3f79f4bdc6 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20100802 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52533-001_b03f0ff9-3c79-438e-87fa-8da29c438109 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20100802 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52533-001_b15dc4f2-8639-49d4-8e21-98849b6a1f4f 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20131101 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52533-001_d0020e87-b826-46db-b980-3436558f1656 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20130425 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52533-001_ec957ed7-ccce-4067-af20-00766fc89680 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20130430 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52533-001_fec562f9-7b6e-43d9-9a90-d3cf3f9f9e80 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20120413 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52533-002_0e099916-4c9d-4972-9b15-7a9340aa0c5e 52533-002 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20100823 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-002_2bd52ec4-707e-4141-a379-c25900f380f9 52533-002 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20111017 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-002_ba790bab-9c34-42aa-8963-54faa5df3e97 52533-002 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20100823 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-002_bc509931-8787-46fb-8d46-d794ed410c13 52533-002 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20130404 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-002_e2dc3784-3395-4843-be0f-c2b3fac0ecde 52533-002 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20120123 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-004_f6dde57f-87f2-4694-9d7d-5fd502fc3a87 52533-004 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140821 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-005_08860913-59ea-45da-ad52-3c89acfcea9f 52533-005 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20131011 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-005_d79919e1-bb86-4af3-8a93-0fd786aa2fd1 52533-005 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20120118 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-005_eb7e7756-68d1-4ecd-8420-18326aac3456 52533-005 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-006_1b5c0fc4-0762-4350-b7d4-70e088575520 52533-006 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20110630 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-006_1fe315d2-a745-4ba5-b81e-70d6f47b4b55 52533-006 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20121031 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-006_2475bc53-423f-4820-8b32-ad78393d3633 52533-006 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20120830 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-006_775fc315-3224-4f80-bba3-0feba9184b9c 52533-006 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-006_98a434db-4540-4f71-a3f0-777cfbc73173 52533-006 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20121019 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-006_a68fa1be-b229-4917-853b-e19e043c8264 52533-006 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20131011 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-008_706000cd-740e-41f3-b4ea-9455f3da5116 52533-008 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-008_c7a65ea5-de8a-443f-a963-f52bc3030976 52533-008 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140821 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-011_91b96674-dfb1-48b6-b9f6-8574790636de 52533-011 HUMAN PRESCRIPTION DRUG Bupivacaine HCl Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20110801 UNAPPROVED DRUG OTHER Cantrell Drug Company BUPIVACAINE HYDROCHLORIDE 1.25 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 52533-012_97223b22-290e-437d-849e-14818780efbc 52533-012 HUMAN PRESCRIPTION DRUG Bupivacaine HCl Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20120518 UNAPPROVED DRUG OTHER Cantrell Drug Company BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 52533-014_6748dba5-40e3-4da6-91a1-b6cf400ece74 52533-014 HUMAN PRESCRIPTION DRUG Cefazolin Sodium Cefazolin Sodium INJECTION, SOLUTION INTRAVENOUS 20111101 UNAPPROVED DRUG OTHER Cantrell Drug Company CEFAZOLIN SODIUM 2 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52533-015_1c403656-b491-40e7-b56e-28e05148ba88 52533-015 HUMAN PRESCRIPTION DRUG Cefazolin Sodium Cefazolin Sodium INJECTION, SOLUTION INTRAVENOUS 20110930 UNAPPROVED DRUG OTHER Cantrell Drug Company CEFAZOLIN SODIUM 2 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52533-024_036c452d-7f25-4a8a-940b-5815c70efcec 52533-024 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20120814 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 10 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-024_160a688b-d2ff-4e01-bf30-a0b5145d2b85 52533-024 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20120412 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 10 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-024_443b77c6-f103-4d04-a2fe-85fd05fb506a 52533-024 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION EPIDURAL; INTRAVENOUS 20130423 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 10 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-024_51953e65-26fb-4c3f-bbc1-b722c61bbca6 52533-024 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20120904 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 10 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-024_81829df3-9cb3-4a3a-bc94-e4291b31414d 52533-024 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20131011 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 10 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-024_a0d778a9-132f-4c7b-8038-6e57acf23c24 52533-024 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20140806 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 10 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-024_a6d6c5df-48a8-4d78-a5b1-4222122b6e8b 52533-024 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20130130 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 10 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-024_c0220342-9978-4424-8962-b29159a491ad 52533-024 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20120123 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 10 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-024_c37361bf-1fea-4979-8cd5-ca255b3c7873 52533-024 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20110726 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 10 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-024_d2fd2441-88ae-45d1-917c-b0ce5131a73f 52533-024 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20110726 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 10 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-024_dec8a56e-c2b5-4917-8c26-8594fb3c02f2 52533-024 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE FENTANYL CITRATE INJECTION, SOLUTION INTRAVENOUS 20120413 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 10 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-025_0a6669a6-692d-4dd6-b9de-66b60e215983 52533-025 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20130130 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 20 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-025_0bcb131c-64da-4f83-bd06-15da9b4ece52 52533-025 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 20 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-025_c96e60ea-3961-42b4-805f-320321fb9eda 52533-025 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20140821 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 20 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-026_2f709e92-b47e-4140-8ca2-4a4e856a99a9 52533-026 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20130827 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 25 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-026_4c71d962-f571-4f25-bfca-1ca5124a6333 52533-026 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20130325 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 25 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-026_5d39d0c6-0e10-4ffc-b837-f64a681b6bea 52533-026 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20140821 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 25 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-026_66a9f9da-d75b-42ab-8358-14982426e3ba 52533-026 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20121019 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 25 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-028_5096fb64-4364-446e-8df8-27e545141b61 52533-028 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAVENOUS 20140805 UNAPPROVED DRUG OTHER Cantrell Drug Company GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52533-028_921b334d-88ac-4554-8ac4-447388db88f2 52533-028 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAVENOUS 20140805 UNAPPROVED DRUG OTHER Cantrell Drug Company GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52533-028_e6784f70-1741-48b4-9659-3b518fb031da 52533-028 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAVENOUS 20140625 UNAPPROVED DRUG OTHER Cantrell Drug Company GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52533-029_966f4240-7b5b-4015-a737-5d8cc77edb7c 52533-029 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20131122 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 30 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52533-034_6b2d1458-8b19-4e66-9945-8cef700dc75f 52533-034 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl INJECTION, SOLUTION INTRAVENOUS 20120518 UNAPPROVED DRUG OTHER Cantrell Drug Company LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52533-034_dc956ab6-b338-4b27-8ae3-050bc5a7aef0 52533-034 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl INJECTION, SOLUTION INTRAVENOUS 20120223 UNAPPROVED DRUG OTHER Cantrell Drug Company LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52533-042_389e438b-7e82-471a-af40-4196ed466866 52533-042 HUMAN PRESCRIPTION DRUG Meperidine HCl Meperidine HCl INJECTION, SOLUTION INTRAVENOUS 20131114 UNAPPROVED DRUG OTHER Cantrell Drug Company MEPERIDINE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-042_5803ba3e-9045-438b-a68b-5ff868855e45 52533-042 HUMAN PRESCRIPTION DRUG Meperidine HCl Meperidine HCl INJECTION, SOLUTION INTRAVENOUS 20120123 UNAPPROVED DRUG OTHER Cantrell Drug Company MEPERIDINE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-042_87c24197-277e-4620-90ff-3c624ed6010f 52533-042 HUMAN PRESCRIPTION DRUG Meperidine HCl Meperidine HCl INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company MEPERIDINE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-042_e8104c2e-14b2-41e8-9050-f4f8664ad79a 52533-042 HUMAN PRESCRIPTION DRUG Meperidine HCl Meperidine HCl INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company MEPERIDINE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-045_87c40c91-665d-4233-9b36-613fd6f19810 52533-045 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRATHECAL 20120824 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE 40 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-048_b9f98eaf-6261-49f5-81dc-e1c212bdb34f 52533-048 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20120730 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 10 [USP&apos'U]/1000mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 52533-050_886dc21d-dbb7-4f61-82c6-dc2baf59bb61 52533-050 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20121109 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 2 [USP&apos'U]/100mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 52533-050_f136e919-83a2-4dbe-b289-2cd2c0c2b494 52533-050 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20111020 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 20 [USP&apos'U]/1000mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 52533-051_3f071d89-76e4-4313-8e37-61c524758737 52533-051 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20121112 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 10 [USP'U]/500mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 52533-051_9126668c-f61e-4da9-87c3-59a48ee7036a 52533-051 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20111020 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 2 [USP'U]/100mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 52533-054_a7bd8a1a-594b-4c80-a4a0-0b720a728d53 52533-054 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20111020 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 30 [USP&apos'U]/500mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 52533-055_3b5b2071-da23-4d84-bdbe-02cf7a4afc6b 52533-055 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20111020 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 30 [USP&apos'U]/500mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 52533-056_0b37f72f-edf6-4195-ae82-b70e3413a008 52533-056 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20111020 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 30 [USP&apos'U]/500mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 52533-056_33dae4b1-7018-459f-a8fe-a6b0059e9445 52533-056 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20130425 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 15 [USP&apos'U]/250mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 52533-059_6051d8f9-3e1e-4c78-a749-bd17f7618e41 52533-059 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAVENOUS 20130501 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-060_cdf724bc-3af5-4b41-b4d9-f261c3141abf 52533-060 HUMAN PRESCRIPTION DRUG Phenylephrine HCl Phenylephrine HCl INJECTION, SOLUTION INTRAVENOUS 20120615 UNAPPROVED DRUG OTHER Cantrell Drug Company PHENYLEPHRINE HYDROCHLORIDE .08 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 52533-060_fa79684a-ba44-4eef-8e88-a892db2aa76a 52533-060 HUMAN PRESCRIPTION DRUG Phenylephrine HCl Phenylephrine HCl INJECTION, SOLUTION INTRAVENOUS 20120830 UNAPPROVED DRUG OTHER Cantrell Drug Company PHENYLEPHRINE HYDROCHLORIDE .08 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 52533-066_532e9143-54f8-4add-82e7-7b23bfed0fd6 52533-066 HUMAN PRESCRIPTION DRUG Ropivacaine HCl Ropivacaine HCl INJECTION, SOLUTION EPIDURAL 20120529 UNAPPROVED DRUG OTHER Cantrell Drug Company ROPIVACAINE HYDROCHLORIDE 2 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 52533-069_fe72d408-9aca-4044-8a98-2bcbb395d85a 52533-069 HUMAN PRESCRIPTION DRUG Vancomycin HCl Vancomycin HCl INJECTION, SOLUTION INTRAVENOUS 20130501 UNAPPROVED DRUG OTHER Cantrell Drug Company VANCOMYCIN HYDROCHLORIDE 4.2 mg/mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 52533-070_14a0b6cb-af4d-42ef-96ff-52976a419aaf 52533-070 HUMAN PRESCRIPTION DRUG Vancomycin HCl Vancomycin HCl INJECTION, SOLUTION INTRAVENOUS 20120525 UNAPPROVED DRUG OTHER Cantrell Drug Company VANCOMYCIN HYDROCHLORIDE 5 mg/mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 52533-070_dce16bbc-4826-4a7f-843d-0f4f81bb6703 52533-070 HUMAN PRESCRIPTION DRUG Vancomycin HCl Vancomycin HCl INJECTION, SOLUTION INTRAVENOUS 20130830 UNAPPROVED DRUG OTHER Cantrell Drug Company VANCOMYCIN HYDROCHLORIDE 5 mg/mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 52533-071_f6e055c7-1f22-4506-bd1e-6dc2eb793aa2 52533-071 HUMAN PRESCRIPTION DRUG Vancomycin HCl Vancomycin HCl INJECTION, SOLUTION INTRAVENOUS 20120525 UNAPPROVED DRUG OTHER Cantrell Drug Company VANCOMYCIN HYDROCHLORIDE 6 mg/mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 52533-074_7ade28d7-cb42-4daf-bea8-9bcce175c477 52533-074 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20111020 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-074_7b06e0a7-2433-46d6-86a7-9e28d31c7e9c 52533-074 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20111020 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-074_d4c18576-18ff-46c1-99fa-8b88ef32b86e 52533-074 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20111020 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-080_3b56263f-62bd-4571-84d6-83b2930ff721 52533-080 HUMAN PRESCRIPTION DRUG Fentanyl Citrate, Bupivacaine HCl Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20140625 UNAPPROVED DRUG OTHER Cantrell Drug Company BUPIVACAINE HYDROCHLORIDE; FENTANYL CITRATE 1.25; 2 mg/mL; ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] CII 52533-080_978ed8c9-229d-406f-aeb3-393ef41a67bb 52533-080 HUMAN PRESCRIPTION DRUG Fentanyl Citrate, Bupivacaine HCl Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20130917 UNAPPROVED DRUG OTHER Cantrell Drug Company BUPIVACAINE HYDROCHLORIDE; FENTANYL CITRATE 1.25; 2 mg/mL; ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] CII 52533-080_b8bc3bee-94e2-43af-9de7-0e00a4310565 52533-080 HUMAN PRESCRIPTION DRUG Fentanyl Citrate, Bupivacaine HCl Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20130325 UNAPPROVED DRUG OTHER Cantrell Drug Company BUPIVACAINE HYDROCHLORIDE; FENTANYL CITRATE 1.25; 2 mg/mL; ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] CII 52533-080_c2d97900-1e9f-46cf-b5c7-773da45f87e2 52533-080 HUMAN PRESCRIPTION DRUG Fentanyl Citrate, Bupivacaine HCl Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20120816 UNAPPROVED DRUG OTHER Cantrell Drug Company BUPIVACAINE HYDROCHLORIDE; FENTANYL CITRATE 1.25; 2 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-081_56079bf1-a667-48e7-9392-85166d7aff21 52533-081 HUMAN PRESCRIPTION DRUG Fentanyl Citrate, Bupivacaine HCl Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20131218 UNAPPROVED DRUG OTHER Cantrell Drug Company BUPIVACAINE HYDROCHLORIDE; FENTANYL CITRATE 1.25; 3 mg/mL; ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] CII 52533-095_0444bd62-dfd0-4363-90e4-d703e720f042 52533-095 HUMAN PRESCRIPTION DRUG Dextrose Dextrose Monohydrate Injection, Solution INJECTION, SOLUTION INTRAVENOUS 20110218 UNAPPROVED DRUG OTHER Cantrell Drug Company DEXTROSE MONOHYDRATE 25 mg/mL 52533-096_f9e573f1-53bc-4cb8-82ed-d7ee761970ca 52533-096 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20110218 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 5 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52533-097_3430d9d4-4f8a-42a9-b703-fa9e59263a34 52533-097 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20120509 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 5 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52533-098_7938e6ac-68cd-41cb-b4e7-d53b1c624b7b 52533-098 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20110630 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 10 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52533-098_8e1c01d2-4cb1-4b2b-8d88-2e90aa1179ff 52533-098 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20121026 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 10 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52533-099_6ff3505e-13ea-4bc8-a709-66b133c5a261 52533-099 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate INJECTION, SOLUTION INTRAVENOUS 20110221 UNAPPROVED DRUG OTHER Cantrell Drug Company MAGNESIUM SULFATE 20 g/500mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 52533-100_7894bb13-6e10-466e-83a9-9d0f8126bbb4 52533-100 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20110222 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 1 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52533-101_10eea951-d568-45fe-8ab3-1450fda1a64c 52533-101 HUMAN PRESCRIPTION DRUG Amiodarone HCl Amiodarone HCl INJECTION, SOLUTION INTRAVENOUS 20110801 UNAPPROVED DRUG OTHER Cantrell Drug Company AMIODARONE HYDROCHLORIDE 1.8 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 52533-101_52c3ce04-e1b7-4cde-b0d8-c716612a0a41 52533-101 HUMAN PRESCRIPTION DRUG Amiodarone HCl Amiodarone HCl INJECTION, SOLUTION INTRAVENOUS 20131018 UNAPPROVED DRUG OTHER Cantrell Drug Company AMIODARONE HYDROCHLORIDE 1.8 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 52533-102_3219848d-81a3-46ba-b18d-49c7343e0ec0 52533-102 HUMAN PRESCRIPTION DRUG Calcium Chloride Calcium Chloride INJECTION, SOLUTION INTRAVENOUS 20110308 UNAPPROVED DRUG OTHER Cantrell Drug Company CALCIUM CHLORIDE 20 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 52533-103_dee23365-9eff-4130-8483-bf6c0b3449e3 52533-103 HUMAN PRESCRIPTION DRUG Diltiazem HCl Diltiazem HCl INJECTION, SOLUTION INTRAVENOUS 20110930 UNAPPROVED DRUG OTHER Cantrell Drug Company DILTIAZEM HYDROCHLORIDE 1 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52533-104_d79d1eb4-bd87-4879-aa42-c571f2040ccb 52533-104 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20111107 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 10 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52533-105_5219e93f-e249-44ee-b692-92f3e76b3d26 52533-105 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20121112 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 2 [USP&apos'U]/100mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 52533-106_3324ca48-b7cc-474c-b14f-d156de08d340 52533-106 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20120809 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 50 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52533-107_ba5bedcd-2ba7-44f4-a92b-8fcac6eaed03 52533-107 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate INJECTION, SOLUTION INTRAVENOUS 20110725 UNAPPROVED DRUG OTHER Cantrell Drug Company MAGNESIUM SULFATE 20 g/250mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 52533-110_41d4f286-e3b9-4e52-b1a5-9969bee3d06a 52533-110 HUMAN PRESCRIPTION DRUG Phenylephrine HCl Phenylephrine HCl INJECTION, SOLUTION INTRAVENOUS 20110630 UNAPPROVED DRUG OTHER Cantrell Drug Company PHENYLEPHRINE HYDROCHLORIDE 160 ug/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 52533-113_2fef8fc4-264f-4548-8f5a-74eba7201b62 52533-113 HUMAN PRESCRIPTION DRUG Cefazolin Sodium Cefazolin Sodium INJECTION, SOLUTION INTRAVENOUS 20131205 UNAPPROVED DRUG OTHER Cantrell Drug Company CEFAZOLIN SODIUM 30 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52533-116_2cbab78a-4293-434f-8d70-9d2db2fdb699 52533-116 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20130314 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-116_56658068-e62c-4afd-8e39-cccfa54ec32f 52533-116 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20130524 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-116_7bf91cd4-51df-4385-a077-ebc24dfb02f0 52533-116 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20131011 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-116_a04e5507-1837-4521-b195-66e4f9bca533 52533-116 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20130605 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-120_40005224-6df3-46be-be19-9b71eb80271a 52533-120 HUMAN PRESCRIPTION DRUG Cefazolin Sodium Cefazolin Sodium INJECTION, SOLUTION INTRAVENOUS 20131011 UNAPPROVED DRUG OTHER Cantrell Drug Company CEFAZOLIN SODIUM 100 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52533-120_b533ef7c-0c75-4de4-a316-81e4a937b98a 52533-120 HUMAN PRESCRIPTION DRUG Cefazolin Sodium Cefazolin Sodium INJECTION, SOLUTION INTRAVENOUS 20131114 UNAPPROVED DRUG OTHER Cantrell Drug Company CEFAZOLIN SODIUM 100 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52533-124_9b0fd03a-6201-414c-b438-91ceaeef01db 52533-124 HUMAN PRESCRIPTION DRUG Fentanyl Citrate, Bupivacaine HCl Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20140630 UNAPPROVED DRUG OTHER Cantrell Drug Company BUPIVACAINE HYDROCHLORIDE; FENTANYL CITRATE 1; 2 mg/mL; ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] CII 52533-124_9d1e1118-b545-4497-ac1c-ba4e52b6bb45 52533-124 HUMAN PRESCRIPTION DRUG Fentanyl Citrate, Bupivacaine HCl Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20140627 UNAPPROVED DRUG OTHER Cantrell Drug Company BUPIVACAINE HYDROCHLORIDE; FENTANYL CITRATE 1; 2 mg/mL; ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] CII 52533-124_de35c21f-b213-403c-bdc7-51999ad6bd00 52533-124 HUMAN PRESCRIPTION DRUG Fentanyl Citrate, Bupivacaine HCl Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20130909 UNAPPROVED DRUG OTHER Cantrell Drug Company BUPIVACAINE HYDROCHLORIDE; FENTANYL CITRATE 1; 2 mg/mL; ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] CII 52533-124_ff183871-dc0a-40ee-ba1e-480dd5c710a5 52533-124 HUMAN PRESCRIPTION DRUG Fentanyl Citrate, Bupivacaine HCl Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20130909 UNAPPROVED DRUG OTHER Cantrell Drug Company BUPIVACAINE HYDROCHLORIDE; FENTANYL CITRATE 1; 2 mg/mL; ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] CII 52533-125_13b971d5-b59b-4d8c-b891-533b495f3faf 52533-125 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20120509 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 4 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52533-129_a7528911-3cfe-44a3-80fd-c7c01a05859a 52533-129 HUMAN PRESCRIPTION DRUG Phenylephrine HCl Phenylephrine HCl INJECTION, SOLUTION INTRAVENOUS 20121016 UNAPPROVED DRUG OTHER Cantrell Drug Company PHENYLEPHRINE HYDROCHLORIDE 50 ug/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 52533-130_5b1c1054-9d9a-4789-a1af-36a67f716cce 52533-130 HUMAN PRESCRIPTION DRUG Phenylephrine HCl Phenylephrine HCl INJECTION, SOLUTION INTRAVENOUS 20131025 UNAPPROVED DRUG OTHER Cantrell Drug Company PHENYLEPHRINE HYDROCHLORIDE 300 ug/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 52533-132_372c9693-0219-4f02-bcc3-cc9f68ab38e5 52533-132 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAVENOUS 20131025 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE 5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-137_08a7f8c9-bfd8-42cb-a1c6-27124ab0cc94 52533-137 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRATHECAL; INTRAVENOUS 20120123 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE .5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-138_70b5656c-8fe5-4474-a6fd-e6e4be49a644 52533-138 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20120829 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 2 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52533-142_06a6c4e5-41c6-41af-bfe1-520f7e0e9420 52533-142 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20120829 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 100 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52533-145_9c8fc8c2-e932-4243-9169-d77a301611c8 52533-145 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-145_b116c32b-06ed-49f3-87cd-06aaf382cf01 52533-145 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-146_bf7c3e88-496f-4863-b94b-ba7d6027b6c7 52533-146 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-146_c746ac99-67f5-4392-a757-763d639b6659 52533-146 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140820 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-147_88997fd5-96d7-43fc-9578-ea03f2a1b4da 52533-147 HUMAN PRESCRIPTION DRUG Phenylephrine HCl Phenylephrine HCl INJECTION, SOLUTION INTRAVENOUS 20120615 UNAPPROVED DRUG OTHER Cantrell Drug Company PHENYLEPHRINE HYDROCHLORIDE 40 ug/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 52533-148_85b3652b-5081-48eb-beac-25e7b80ea9cf 52533-148 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20120322 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM .5 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52533-157_302793ab-b633-44c0-9c5b-7a5e65a7f0f3 52533-157 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20140903 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE .5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52533-157_3575bf68-e932-4198-bdb7-038b4f11801d 52533-157 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20130130 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE .5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52533-160_26d9e9ec-1cde-4f1a-89a5-96b11f58c955 52533-160 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAVENOUS 20120129 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-160_2921dd49-287c-4a7a-b4f8-cd6666789141 52533-160 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAVENOUS 20120816 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-160_4dc280fc-fcb5-44dd-9817-1c104984fa43 52533-160 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-160_8fd5aba8-887e-4c9a-a6b9-fa5d017b2e3c 52533-160 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAVENOUS 20140819 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-160_959b1f25-0de9-40d2-9429-32289f132ac1 52533-160 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAVENOUS 20130319 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-160_bbf9bd2f-f34e-4fe9-bd8b-9c84a9173550 52533-160 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAVENOUS 20120816 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-160_d38443a8-8ba6-47eb-aa05-d2a9dad4c92d 52533-160 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION EPIDURAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20130909 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-160_ee32854a-e045-47d6-bdbc-d97b41b2eda2 52533-160 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION EPIDURAL; INTRATHECAL; INTRAVENOUS 20130920 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-161_a018a9d3-08f8-458f-868d-a0df132a30be 52533-161 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION EPIDURAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120222 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-163_522ab18c-3d41-40cc-aa92-19bfd5168338 52533-163 HUMAN PRESCRIPTION DRUG Nicardipine HCl Nicardipine HCl INJECTION, SOLUTION INTRAVENOUS 20130628 UNAPPROVED DRUG OTHER Cantrell Drug Company NICARDIPINE HYDROCHLORIDE .2 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 52533-164_0acf159a-f459-44fb-ad50-c52f6e6c2b14 52533-164 HUMAN PRESCRIPTION DRUG Norepinephrine Bitartrate Norepinephrine Bitartrate INJECTION, SOLUTION INTRAVENOUS 20120622 UNAPPROVED DRUG OTHER Cantrell Drug Company NOREPINEPHRINE BITARTRATE 64 ug/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52533-165_39eaa55c-765d-4e64-b1d7-9ad219f85c70 52533-165 HUMAN PRESCRIPTION DRUG Norepinephrine Bitartrate Norepinephrine Bitartrate INJECTION, SOLUTION INTRAVENOUS 20120412 UNAPPROVED DRUG OTHER Cantrell Drug Company NOREPINEPHRINE BITARTRATE 16 ug/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52533-166_71029a9b-4e20-4d9f-b866-4cb18c4c8618 52533-166 HUMAN PRESCRIPTION DRUG Norepinephrine Bitartrate Norepinephrine Bitartrate INJECTION, SOLUTION INTRAVENOUS 20120412 UNAPPROVED DRUG OTHER Cantrell Drug Company NOREPINEPHRINE BITARTRATE 32 ug/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52533-169_c2d4d429-124d-4627-90d1-9b0ec618b571 52533-169 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20111020 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 20 [USP'U]/1000mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 52533-170_494203c0-7b4f-474f-9582-048d148d65f4 52533-170 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20110701 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 30 [USP&apos'U]/500mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 52533-171_0876071f-9b42-4799-8f16-fda80c5b7306 52533-171 HUMAN PRESCRIPTION DRUG Phenylephrine HCl Phenylephrine HCl INJECTION, SOLUTION INTRAVENOUS 20120830 UNAPPROVED DRUG OTHER Cantrell Drug Company PHENYLEPHRINE HYDROCHLORIDE 100 ug/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 52533-172_24f07811-6f00-4d0c-8fe1-74ffbc17e404 52533-172 HUMAN PRESCRIPTION DRUG Famotidine Famotidine INJECTION, SOLUTION INTRAVENOUS 20140611 UNAPPROVED DRUG OTHER Cantrell Drug Company FAMOTIDINE 2 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 52533-174_3f9647da-f362-4f64-ac53-9f43fd359d62 52533-174 HUMAN PRESCRIPTION DRUG Fentanyl Citrate, Bupivacaine HCl Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20130812 UNAPPROVED DRUG OTHER Cantrell Drug Company BUPIVACAINE HYDROCHLORIDE; FENTANYL CITRATE 1.25; 1 mg/mL; ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] CII 52533-177_af37d776-18c2-4733-8673-1d758fee1d6b 52533-177 HUMAN PRESCRIPTION DRUG Promethazine HCl Promethazine HCl INJECTION, SOLUTION INTRAVENOUS 20140529 UNAPPROVED DRUG OTHER Cantrell Drug Company PROMETHAZINE HYDROCHLORIDE .5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52533-178_5717f581-f3a7-48ba-a266-96f934bca668 52533-178 HUMAN PRESCRIPTION DRUG Promethazine HCl Promethazine HCl INJECTION, SOLUTION INTRAVENOUS 20140527 UNAPPROVED DRUG OTHER Cantrell Drug Company PROMETHAZINE HYDROCHLORIDE 1 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52533-179_22ba36b4-2474-4f9b-9908-b41c5678da84 52533-179 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20120509 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 100 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52533-198_b92579cb-dd1b-4f8a-a8a7-7a4e3f3ad0ac 52533-198 HUMAN PRESCRIPTION DRUG Diltiazem HCl Diltiazem HCl INJECTION, SOLUTION INTRAVENOUS 20131022 UNAPPROVED DRUG OTHER Cantrell Drug Company DILTIAZEM HYDROCHLORIDE .83 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52533-202_e6911cf4-65b0-4c9a-9aeb-323fa98f2122 52533-202 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20121012 UNAPPROVED DRUG OTHER Cantrell Drug Company IPRATROPIUM BROMIDE .5 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52533-204_40c4811d-3088-40ee-9c7b-beb57813276d 52533-204 HUMAN PRESCRIPTION DRUG Promethazine HCl Promethazine HCl INJECTION, SOLUTION INTRAVENOUS 20140527 UNAPPROVED DRUG OTHER Cantrell Drug Company PROMETHAZINE HYDROCHLORIDE .625 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52533-205_0dcf98ab-fbb6-4b56-9959-e5b55eee1769 52533-205 HUMAN PRESCRIPTION DRUG Phenylephrine HCl Phenylephrine HCl INJECTION, SOLUTION INTRAVENOUS 20130314 UNAPPROVED DRUG OTHER Cantrell Drug Company PHENYLEPHRINE HYDROCHLORIDE 1 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 52533-205_7736876c-b6ba-41d5-a12b-084d599752bc 52533-205 HUMAN PRESCRIPTION DRUG Phenylephrine HCl Phenylephrine HCl INJECTION, SOLUTION INTRAVENOUS 20130408 UNAPPROVED DRUG OTHER Cantrell Drug Company PHENYLEPHRINE HYDROCHLORIDE 1 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 52533-211_36acde31-b65c-4648-8fed-5bfb41a89806 52533-211 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20121113 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 4 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52533-214_f62ee14d-24eb-4eb0-9866-c88d9026f7fc 52533-214 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20131122 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 5 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52533-215_f80df7a0-ec3e-4736-bfe3-fddaddae0812 52533-215 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20140408 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 40 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52533-216_b85145ea-46ad-49da-bf4e-641316e7fcaa 52533-216 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20121221 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 50 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52536-250_9a521dca-1e3a-42c6-9e8b-20da018e84c0 52536-250 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140317 ANDA ANDA202887 Wilshire Pharmaceuticals, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 52536-251_9a521dca-1e3a-42c6-9e8b-20da018e84c0 52536-251 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140317 ANDA ANDA202887 Wilshire Pharmaceuticals, Inc. LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 52536-252_9a521dca-1e3a-42c6-9e8b-20da018e84c0 52536-252 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140317 ANDA ANDA202887 Wilshire Pharmaceuticals, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 52536-253_9a521dca-1e3a-42c6-9e8b-20da018e84c0 52536-253 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140317 ANDA ANDA202887 Wilshire Pharmaceuticals, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 52536-300_69b7a502-e77e-4525-a65f-0a5ee03af586 52536-300 HUMAN PRESCRIPTION DRUG Nitroglycerin Lingual nitroglycerin SPRAY, METERED ORAL 20110201 NDA NDA018705 Wilshire Pharmaceuticals, Inc. NITROGLYCERIN 400 ug/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 52536-500_9284e3d9-5c18-4754-bdf7-f03ee730e55a 52536-500 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate TABLET ORAL 20120716 ANDA ANDA090533 Wilshire Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 52536-510_9284e3d9-5c18-4754-bdf7-f03ee730e55a 52536-510 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate TABLET ORAL 20120720 ANDA ANDA090533 Wilshire Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 52544-011_23ea8c06-4e0c-4b34-9a93-bfeedf62a4a0 52544-011 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52544-032_23ea8c06-4e0c-4b34-9a93-bfeedf62a4a0 52544-032 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52544-039_23ea8c06-4e0c-4b34-9a93-bfeedf62a4a0 52544-039 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120507 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52544-041_9f6f76b1-bc7e-4dd0-bad5-ad5b4873664a 52544-041 HUMAN PRESCRIPTION DRUG Gelnique Oxybutynin GEL TRANSDERMAL 20120402 NDA NDA202513 Watson Pharma, Inc. OXYBUTYNIN 28 mg/.92g Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52544-044_5f5514bc-8518-4d83-b6fe-98896adf3044 52544-044 HUMAN PRESCRIPTION DRUG Cordran Flurandrenolide TAPE TOPICAL 19690729 NDA NDA016455 Actavis Pharma, Inc. FLURANDRENOLIDE 4 ug/cm2 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52544-045_a7c5421d-de07-4406-849b-109619a76696 52544-045 HUMAN PRESCRIPTION DRUG Condylox podofilox GEL TOPICAL 19970313 NDA NDA020529 Watson Pharma, Inc. PODOFILOX 5 mg/g Decreased Mitosis [PE] 52544-046_9371d25e-0a32-45ca-b4e8-dd9fea41ad2e 52544-046 HUMAN PRESCRIPTION DRUG Condylox podofilox SOLUTION TOPICAL 19901213 NDA NDA019795 Watson Pharma, Inc. PODOFILOX 5 mg/mL Decreased Mitosis [PE] 52544-048_29735bf2-e08e-4f60-a640-0e3b9ccca80f 52544-048 HUMAN PRESCRIPTION DRUG Cormax clobetasol propionate OINTMENT TOPICAL 20080918 ANDA ANDA074221 Watson Pharma, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52544-052_23ea8c06-4e0c-4b34-9a93-bfeedf62a4a0 52544-052 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52544-063_23ea8c06-4e0c-4b34-9a93-bfeedf62a4a0 52544-063 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52544-065_51018387-0903-495c-b803-b12e28ce6edd 52544-065 HUMAN OTC DRUG Next Choice One Dose Levonorgestrel TABLET ORAL 20140512 ANDA ANDA200670 Watson Pharma, Inc. LEVONORGESTREL 1.5 mg/1 52544-076_d42ec1a1-db9e-419e-8b0f-2bf0c4bec189 52544-076 HUMAN PRESCRIPTION DRUG Androderm Testosterone PATCH TRANSDERMAL 19950929 NDA NDA020489 Actavis Pharma, Inc. TESTOSTERONE 2 mg/d Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 52544-077_d42ec1a1-db9e-419e-8b0f-2bf0c4bec189 52544-077 HUMAN PRESCRIPTION DRUG Androderm Testosterone PATCH TRANSDERMAL 19950929 NDA NDA020489 Actavis Pharma, Inc. TESTOSTERONE 4 mg/d Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 52544-079_3144b7d5-0ddb-4666-ae42-2cf0b2fc21ec 52544-079 HUMAN PRESCRIPTION DRUG PreQue 10 Prenatal Nutrition with CoQ10 and Lycopene TABLET ORAL 20111101 UNAPPROVED DRUG OTHER Watson Pharma, Inc. .ALPHA.-TOCOPHEROL; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON PENTACARBONYL; LYCOPENE; MAGNESIUM OXIDE; RIBOFLAVIN; SELENIUM; THIAMINE; UBIDECARENONE; VITAMIN A; ZINC OXIDE 15; 30; 120; 1; 1; 50; 25; .5; 15; 5; 10; 1.7; 7.5; 1; 50; 1250; 12.5 [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 52544-080_1c5b6c59-3707-439c-b24f-cae43e89c8d4 52544-080 HUMAN PRESCRIPTION DRUG Fioricet Butalbital, Acetaminophen, and Caffeine CAPSULE ORAL 20130729 ANDA ANDA040885 Actavis Pharma, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 300; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 52544-082_5123f020-8307-41a4-b14d-c0267502707b 52544-082 HUMAN PRESCRIPTION DRUG Fioricet with Codeine Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE ORAL 20130729 ANDA ANDA076560 Watson Pharma, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 300; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 52544-084_649c773f-91a5-4169-a46f-ca045c3d0670 52544-084 HUMAN PRESCRIPTION DRUG GELNIQUE oxybutynin chloride GEL TRANSDERMAL 20090515 NDA NDA022204 Watson Pharma, Inc. OXYBUTYNIN CHLORIDE 100 mg/g Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52544-092_02d5978a-ae60-48d9-9640-544ced251ce3 52544-092 HUMAN PRESCRIPTION DRUG Trelstar triptorelin pamoate KIT 20100311 NDA NDA022437 Actavis Pharma, Inc. 52544-143_41312f7a-36b1-415a-bafc-d0b44d4ee217 52544-143 HUMAN PRESCRIPTION DRUG Tilia Fe Norethindrone Acetate and Ethinyl Estradiol KIT ORAL 20101201 ANDA ANDA076629 Watson Pharma, Inc. 52544-149_9a07117b-935e-4e0e-a74f-67840d26a788 52544-149 HUMAN PRESCRIPTION DRUG Nulecit sodium ferric gluconate complex INJECTION INTRAVENOUS 20110331 ANDA ANDA078215 Watson Pharma, Inc. SODIUM FERRIC GLUCONATE COMPLEX 12.5 mg/mL 52544-151_aee5eba2-4500-40e7-ad66-7cd2a8829ffe 52544-151 HUMAN PRESCRIPTION DRUG RAPAFLO silodosin CAPSULE ORAL 20090323 NDA NDA022206 Actavis Pharma, Inc. SILODOSIN 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52544-152_aee5eba2-4500-40e7-ad66-7cd2a8829ffe 52544-152 HUMAN PRESCRIPTION DRUG RAPAFLO silodosin CAPSULE ORAL 20090323 NDA NDA022206 Actavis Pharma, Inc. SILODOSIN 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52544-153_02d5978a-ae60-48d9-9640-544ced251ce3 52544-153 HUMAN PRESCRIPTION DRUG Trelstar triptorelin pamoate INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION INTRAMUSCULAR 20000615 NDA NDA020715 Actavis Pharma, Inc. TRIPTORELIN PAMOATE 3.75 mg/2mL Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] 52544-154_02d5978a-ae60-48d9-9640-544ced251ce3 52544-154 HUMAN PRESCRIPTION DRUG Trelstar triptorelin pamoate INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION INTRAMUSCULAR 20010629 NDA NDA021288 Actavis Pharma, Inc. TRIPTORELIN PAMOATE 11.25 mg/2mL Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] 52544-156_02d5978a-ae60-48d9-9640-544ced251ce3 52544-156 HUMAN PRESCRIPTION DRUG Trelstar triptorelin pamoate INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION INTRAMUSCULAR 20100311 NDA NDA022437 Actavis Pharma, Inc. TRIPTORELIN PAMOATE 22.5 mg/2mL Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] 52544-161_1da72b19-1704-4993-99ec-1cb5090c9a3d 52544-161 HUMAN PRESCRIPTION DRUG Norco Hydrocodone Bitatrate and Acetaminophen TABLET ORAL 20130312 ANDA ANDA040148 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 52544-162_1da72b19-1704-4993-99ec-1cb5090c9a3d 52544-162 HUMAN PRESCRIPTION DRUG Norco Hydrocodone Bitatrate and Acetaminophen TABLET ORAL 20130312 ANDA ANDA040148 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 52544-163_c422e125-133c-4b9d-ad05-2d27f7660079 52544-163 HUMAN PRESCRIPTION DRUG Maxidone Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130312 ANDA ANDA040094 Watson Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 52544-164_23ea8c06-4e0c-4b34-9a93-bfeedf62a4a0 52544-164 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52544-175_690f95b9-077c-4fdd-b9dc-74a278dc389a 52544-175 HUMAN PRESCRIPTION DRUG Tilia Fe Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate KIT 20071001 NDA NDA020130 Watson Pharma, Inc. 52544-188_02d5978a-ae60-48d9-9640-544ced251ce3 52544-188 HUMAN PRESCRIPTION DRUG Trelstar triptorelin pamoate KIT 20010629 NDA NDA021288 Actavis Pharma, Inc. 52544-189_02d5978a-ae60-48d9-9640-544ced251ce3 52544-189 HUMAN PRESCRIPTION DRUG Trelstar triptorelin pamoate KIT 20000615 NDA NDA020715 Actavis Pharma, Inc. 52544-204_60d229ab-7f9d-4391-8e54-01e9b88c07dc 52544-204 HUMAN PRESCRIPTION DRUG GENERESS Fe norethindrone and ethinyl estradiol and ferrous fumarate KIT ORAL 20111223 NDA NDA022573 Watson Pharma, Inc. 52544-210_efa6758e-becf-464a-815d-1511217189e0 52544-210 HUMAN PRESCRIPTION DRUG Zenchent Norethindrone and Ethinyl Estradiol KIT 20070101 ANDA ANDA076238 Watson Pharma, Inc. 52544-211_23ea8c06-4e0c-4b34-9a93-bfeedf62a4a0 52544-211 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52544-219_794a7110-5481-48a6-8102-6f6e09f3cfc4 52544-219 HUMAN PRESCRIPTION DRUG Leena Norethindrone and Ethinyl Estradiol KIT ORAL 20050112 NDA AUTHORIZED GENERIC NDA018977 Actavis Pharma, Inc. 52544-220_23ea8c06-4e0c-4b34-9a93-bfeedf62a4a0 52544-220 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52544-228_685a835d-6d41-4895-a3e5-a02e885dc2a0 52544-228 HUMAN PRESCRIPTION DRUG Amethia Lo levonorgestrel/ethinyl estradiol and ethinyl estradiol KIT 20111025 ANDA ANDA200407 Watson Pharma, Inc. 52544-233_0e1f5ef0-4d36-4547-8c6b-2cd7e843b521 52544-233 HUMAN PRESCRIPTION DRUG Microgestin Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20140912 NDA AUTHORIZED GENERIC NDA017355 Actavis Pharma, Inc. 52544-235_e299e6ac-a1bb-4b6e-91ae-5ddd074a3d49 52544-235 HUMAN PRESCRIPTION DRUG Nor QD norethindrone TABLET ORAL 19730102 NDA NDA017060 Watson Pharma, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 52544-238_2dea8cbb-5948-438a-8baa-93de23dfe6b1 52544-238 HUMAN PRESCRIPTION DRUG Ella ulipristal acetate TABLET ORAL 20100813 NDA NDA022474 Watson Pharma, Inc. ULIPRISTAL ACETATE 30 mg/1 52544-245_2013cfa5-7b44-42d0-addd-4fc368d7e8d8 52544-245 HUMAN PRESCRIPTION DRUG Necon Norethindrone and Mestranol KIT 19671117 NDA NDA016659 Watson Pharma, Inc. 52544-247_57cd68a1-c241-41af-8678-469ff2ee15ba 52544-247 HUMAN PRESCRIPTION DRUG MonoNessa norgestimate and ethinyl estradiol KIT 20030101 NDA NDA019653 Watson Pharmaceuticals 52544-248_2f0cd8ea-c788-40ce-8675-e791415fc14d 52544-248 HUMAN PRESCRIPTION DRUG TriNessa norgestimate and ethinyl estradiol KIT 20030211 NDA NDA019653 Watson Pharmaceuticals 52544-249_0e1f5ef0-4d36-4547-8c6b-2cd7e843b521 52544-249 HUMAN PRESCRIPTION DRUG Microgestin Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20140916 NDA AUTHORIZED GENERIC NDA017354 Actavis Pharma, Inc. 52544-254_8b5e1c8c-bdd2-46fb-96d8-c1cf68a7abbc 52544-254 HUMAN PRESCRIPTION DRUG Brevicon Norethindrone and ethinyl estradiol KIT 19760329 NDA NDA017743 Actavis Pharma, Inc. 52544-255_b58daf3c-1e7b-4ec8-af5f-8ff6250b14ad 52544-255 HUMAN PRESCRIPTION DRUG Crinone progesterone GEL VAGINAL 19970513 20150331 NDA NDA020701 Watson Pharma, Inc. PROGESTERONE 45 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] 52544-256_b58daf3c-1e7b-4ec8-af5f-8ff6250b14ad 52544-256 HUMAN PRESCRIPTION DRUG Crinone progesterone GEL VAGINAL 19970513 20150331 NDA NDA020701 Watson Pharma, Inc. PROGESTERONE 90 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] 52544-259_8b5e1c8c-bdd2-46fb-96d8-c1cf68a7abbc 52544-259 HUMAN PRESCRIPTION DRUG Norinyl Norethindrone and ethinyl estradiol KIT 19741227 NDA NDA017565 Actavis Pharma, Inc. 52544-265_8b5e1c8c-bdd2-46fb-96d8-c1cf68a7abbc 52544-265 HUMAN PRESCRIPTION DRUG Norinyl Norethindrone and Mestranol KIT 19671117 NDA NDA016659 Actavis Pharma, Inc. 52544-268_3cc32883-01eb-4270-930a-751358f49b71 52544-268 HUMAN PRESCRIPTION DRUG Amethia levonorgestrel and ethinyl estradiol and ethinyl estradiol KIT 20110531 ANDA ANDA078834 Watson Pharma, Inc. 52544-274_8b39fc1e-fb01-4f77-8f9a-9fe5d07b1555 52544-274 HUMAN PRESCRIPTION DRUG Tri-Norinyl Norethindrone and Ethinyl Estradiol KIT 19840413 NDA NDA018977 Watson Pharma, Inc. 52544-275_7adc472e-d563-46ca-ac54-b1f490821791 52544-275 HUMAN PRESCRIPTION DRUG Next Choice levonorgestrel TABLET ORAL 20090904 ANDA ANDA078665 Watson Pharma, Inc. LEVONORGESTREL .75 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 52544-276_0e1f5ef0-4d36-4547-8c6b-2cd7e843b521 52544-276 HUMAN PRESCRIPTION DRUG Microgestin Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20140818 NDA AUTHORIZED GENERIC NDA017876 Actavis Pharma, Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE .02; 1 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 52544-279_a6b608fb-5c6e-4223-8229-2677cfd89208 52544-279 HUMAN PRESCRIPTION DRUG Levora Levonorgestrel and Ethinyl Estradiol KIT ORAL 19931213 ANDA ANDA073594 Watson Pharma, Inc. 52544-283_b58daf3c-1e7b-4ec8-af5f-8ff6250b14ad 52544-283 HUMAN PRESCRIPTION DRUG Crinone progesterone GEL VAGINAL 19970513 20150331 NDA NDA020701 Watson Pharma, Inc. PROGESTERONE 45 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] 52544-284_b58daf3c-1e7b-4ec8-af5f-8ff6250b14ad 52544-284 HUMAN PRESCRIPTION DRUG Crinone progesterone GEL VAGINAL 19970513 20150331 NDA NDA020701 Watson Pharma, Inc. PROGESTERONE 90 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] 52544-287_2af11476-0b50-4c69-9722-366ce2eb1a31 52544-287 HUMAN PRESCRIPTION DRUG Levonorgestrel Next Choice One Dose TABLET ORAL 20120716 ANDA ANDA200670 Watson Pharma, Inc. LEVONORGESTREL 1.5 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 52544-290_0e1f5ef0-4d36-4547-8c6b-2cd7e843b521 52544-290 HUMAN PRESCRIPTION DRUG Microgestin Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20140807 NDA AUTHORIZED GENERIC NDA017875 Actavis Pharma, Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE .03; 1.5 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 52544-291_0fd08994-b1fe-41e5-986a-457e368c06d9 52544-291 HUMAN PRESCRIPTION DRUG Trivora Levonogestrel and Ethinyl Estradiol KIT ORAL 19971218 ANDA ANDA074538 Watson Pharma, Inc. 52544-292_ce50efa0-4284-4c94-9a8a-56b3567623e5 52544-292 HUMAN PRESCRIPTION DRUG Zenchent FE Norethindrone and Ethinyl Estradiol KIT 20110926 ANDA ANDA078892 Watson Pharma, Inc. 52544-295_003a2b73-31cf-45b1-b112-51001f0cd17a 52544-295 HUMAN PRESCRIPTION DRUG Amethyst Levonorgestrel and Ethinyl Estradiol TABLET ORAL 20110613 ANDA ANDA079218 Watson Pharma, Inc. ETHINYL ESTRADIOL; LEVONORGESTREL 20; 90 ug/1; ug/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 52544-383_f5ef9b7a-e41b-4e50-a27d-4d65e17dc71b 52544-383 HUMAN PRESCRIPTION DRUG Zovia 1/35E-28 Ethynodiol Diacetate and Ethinyl Estradiol KIT ORAL 19911230 ANDA ANDA072721 Watson Pharma, Inc. 52544-384_f5ef9b7a-e41b-4e50-a27d-4d65e17dc71b 52544-384 HUMAN PRESCRIPTION DRUG Zovia 1/50E-28 Ethynodiol Diacetate and Ethinyl Estradiol KIT ORAL 19911230 ANDA ANDA072723 Watson Pharma, Inc. 52544-471_48991cce-698c-4324-8b2d-44889547369c 52544-471 HUMAN PRESCRIPTION DRUG Alora Estradiol Transdermal System PATCH TRANSDERMAL 19961220 NDA NDA020655 Actavis Pharma, Inc. ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 52544-472_48991cce-698c-4324-8b2d-44889547369c 52544-472 HUMAN PRESCRIPTION DRUG Alora Estradiol Transdermal System PATCH TRANSDERMAL 19961220 NDA NDA020655 Actavis Pharma, Inc. ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 52544-473_48991cce-698c-4324-8b2d-44889547369c 52544-473 HUMAN PRESCRIPTION DRUG Alora Estradiol Transdermal System PATCH TRANSDERMAL 19961220 NDA NDA020655 Actavis Pharma, Inc. ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 52544-475_de373e5a-0a5e-405c-9945-44828b4c7efb 52544-475 HUMAN PRESCRIPTION DRUG NEXT CHOICE levonorgestrel TABLET ORAL 20090721 ANDA ANDA078666 Watson Pharma, Inc. LEVONORGESTREL .75 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 52544-484_22dcea44-d5c1-476a-ac1b-734f3d000b8f 52544-484 HUMAN PRESCRIPTION DRUG Dilacor XR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19980318 ANDA ANDA075124 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52544-494_5422c787-d301-44e3-9f64-701c2714eda6 52544-494 HUMAN PRESCRIPTION DRUG LOXITANE loxapine succinate CAPSULE ORAL 19880615 ANDA ANDA072204 Watson Pharma, Inc. LOXAPINE SUCCINATE 5 mg/1 52544-495_5422c787-d301-44e3-9f64-701c2714eda6 52544-495 HUMAN PRESCRIPTION DRUG LOXITANE loxapine succinate CAPSULE ORAL 19880615 ANDA ANDA072205 Watson Pharma, Inc. LOXAPINE SUCCINATE 10 mg/1 52544-496_5422c787-d301-44e3-9f64-701c2714eda6 52544-496 HUMAN PRESCRIPTION DRUG LOXITANE loxapine succinate CAPSULE ORAL 19880615 ANDA ANDA072206 Watson Pharma, Inc. LOXAPINE SUCCINATE 25 mg/1 52544-497_5422c787-d301-44e3-9f64-701c2714eda6 52544-497 HUMAN PRESCRIPTION DRUG LOXITANE loxapine succinate CAPSULE ORAL 19880615 ANDA ANDA072062 Watson Pharma, Inc. LOXAPINE SUCCINATE 50 mg/1 52544-550_ea79aa51-8330-47f6-ad72-d6976124211c 52544-550 HUMAN PRESCRIPTION DRUG Necon 0.5/35 Norethindrone and Ethinyl Estradiol Tablets KIT 19870129 ANDA ANDA070686 Watson Pharma, Inc. 52544-552_ea79aa51-8330-47f6-ad72-d6976124211c 52544-552 HUMAN PRESCRIPTION DRUG NECON 1/35 Norethindrone and Ethinyl Estradiol KIT 19870129 ANDA ANDA070687 Watson Pharma, Inc. 52544-554_ea79aa51-8330-47f6-ad72-d6976124211c 52544-554 HUMAN PRESCRIPTION DRUG Necon 10/11 Norethindrone and Ethinyl Estradiol Tablets KIT 19880401 ANDA ANDA071044 Watson Pharma, Inc. 52544-622_b3663bf3-2ebc-47d3-a2ed-5de5830ef79c 52544-622 HUMAN PRESCRIPTION DRUG Microzide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 19961227 NDA NDA020504 Watson Pharma, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 52544-629_cc586725-7f2a-4db4-832d-2f88a35e8d38 52544-629 HUMAN PRESCRIPTION DRUG Nora BE Norethindrone TABLET ORAL 20050512 NDA AUTHORIZED GENERIC NDA017060 Watson Pharma, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 52544-630_604504a7-81e9-4d19-a161-96ee509f0d81 52544-630 HUMAN PRESCRIPTION DRUG Microgestin Fe Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20010205 20151130 ANDA ANDA075647 Actavis Pharma, Inc. 52544-631_604504a7-81e9-4d19-a161-96ee509f0d81 52544-631 HUMAN PRESCRIPTION DRUG Microgestin Fe Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20010205 20151130 ANDA ANDA075548 Actavis Pharma, Inc. 52544-634_6ec1d32a-0a82-412c-ad30-4786ed847fef 52544-634 HUMAN PRESCRIPTION DRUG Maxidone Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19990322 ANDA ANDA040094 Watson Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 52544-690_08ea4931-c73d-4127-81be-7194297cc65d 52544-690 HUMAN PRESCRIPTION DRUG Matzim LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110328 ANDA ANDA077686 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52544-691_08ea4931-c73d-4127-81be-7194297cc65d 52544-691 HUMAN PRESCRIPTION DRUG Matzim LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110328 ANDA ANDA077686 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52544-692_08ea4931-c73d-4127-81be-7194297cc65d 52544-692 HUMAN PRESCRIPTION DRUG Matzim LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110328 ANDA ANDA077686 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52544-693_08ea4931-c73d-4127-81be-7194297cc65d 52544-693 HUMAN PRESCRIPTION DRUG Matzim LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110328 ANDA ANDA077686 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52544-694_08ea4931-c73d-4127-81be-7194297cc65d 52544-694 HUMAN PRESCRIPTION DRUG Matzim LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110328 ANDA ANDA077686 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52544-695_08ea4931-c73d-4127-81be-7194297cc65d 52544-695 HUMAN PRESCRIPTION DRUG Matzim LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110328 ANDA ANDA077686 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52544-732_945b27e6-d3eb-419c-9869-440bef54ed31 52544-732 HUMAN PRESCRIPTION DRUG Dilacor XR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19920529 NDA NDA020092 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52544-733_945b27e6-d3eb-419c-9869-440bef54ed31 52544-733 HUMAN PRESCRIPTION DRUG Dilacor XR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19920529 NDA NDA020092 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52544-734_945b27e6-d3eb-419c-9869-440bef54ed31 52544-734 HUMAN PRESCRIPTION DRUG Dilacor XR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19920529 NDA NDA020092 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52544-847_220444d4-b158-4781-9ffe-4e94056d262f 52544-847 HUMAN PRESCRIPTION DRUG Low-Ogestrel Norgestrel and Ethinyl Estradiol KIT 19990728 ANDA ANDA075288 Watson Pharma, Inc. 52544-848_b2007028-e668-4305-bd0c-6bd3d686d1ab 52544-848 HUMAN PRESCRIPTION DRUG Ogestrel 0.5/50 Norgestrel and Ethinyl Estradiol Tablets KIT 19991215 ANDA ANDA075406 Watson Pharma, Inc. 52544-884_48991cce-698c-4324-8b2d-44889547369c 52544-884 HUMAN PRESCRIPTION DRUG Alora Estradiol Transdermal System PATCH TRANSDERMAL 20020405 NDA NDA020655 Actavis Pharma, Inc. ESTRADIOL .025 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 52544-892_ec9d651b-2821-4e7f-8437-1cfe5ee70602 52544-892 HUMAN PRESCRIPTION DRUG Jolivette NORETHINDRONE TABLET ORAL 20030301 NDA NDA016954 Actavis Pharma, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 52544-896_23ea8c06-4e0c-4b34-9a93-bfeedf62a4a0 52544-896 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52544-913_15350d4f-7928-469e-ae76-9723367f1832 52544-913 HUMAN PRESCRIPTION DRUG Norco Hydrocodone Bitartate and Acetaminophen TABLET ORAL 19970625 ANDA ANDA040099 Actavis Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 52544-920_668c6c54-bf5c-4530-b0cf-c5683ed5e43f 52544-920 HUMAN PRESCRIPTION DRUG OXYTROL Oxybutynin PATCH TRANSDERMAL 20030226 NDA NDA021351 Watson Pharma, Inc. OXYBUTYNIN 3.9 mg/d Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52544-930_5d7eed06-3384-4166-9694-0bf652432432 52544-930 HUMAN PRESCRIPTION DRUG Actigall Ursodiol CAPSULE ORAL 19871231 NDA NDA019594 Watson Pharma, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 52544-931_aead060b-cb47-4163-a1d8-8829837f2952 52544-931 HUMAN PRESCRIPTION DRUG INFeD Iron Dextran INJECTION INTRAMUSCULAR; INTRAVENOUS 19740429 NDA NDA017441 Actavis Pharma, Inc. IRON DEXTRAN 50 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 52544-936_aa28498c-3d94-4984-969d-196b22dfc071 52544-936 HUMAN PRESCRIPTION DRUG Necon 777 norethindrone and ethinyl estradiol KIT 20021207 NDA NDA018985 Watson Pharma Inc 52544-940_e53e6005-b8ce-44f1-ba32-f2691b4d59c0 52544-940 HUMAN PRESCRIPTION DRUG Azurette Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol KIT 20081229 ANDA ANDA076916 Watson Pharma, Inc. 52544-949_6c5f37c4-34fe-4dba-8fae-43c274e23495 52544-949 HUMAN PRESCRIPTION DRUG Lutera Levonorgestrel and Ethinyl Estradiol KIT 20041118 ANDA ANDA076625 Watson Pharma, Inc. 52544-950_604504a7-81e9-4d19-a161-96ee509f0d81 52544-950 HUMAN PRESCRIPTION DRUG Microgestin Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20010205 20150930 ANDA ANDA075647 Actavis Pharma, Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE .02; 1 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 52544-951_604504a7-81e9-4d19-a161-96ee509f0d81 52544-951 HUMAN PRESCRIPTION DRUG Microgestin Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20010205 20150930 ANDA ANDA075548 Actavis Pharma, Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE .03; 1.5 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 52544-953_c3183ba3-b146-4937-8602-a14b0f898dbf 52544-953 HUMAN PRESCRIPTION DRUG Zenchent Norethindrone and Ethinyl Estradiol KIT 20100722 ANDA ANDA078323 Watson Pharma, Inc. 52544-954_2fcd8efd-1de4-45ca-8bb5-3d2a3cfb2d5d 52544-954 HUMAN PRESCRIPTION DRUG Reclipsen Desogestrel and Ethinyl Estradiol KIT 20050801 ANDA ANDA076915 Watson Pharma, Inc. 52544-955_69f47af3-63ae-4f8a-afab-23376bb5d26f 52544-955 HUMAN PRESCRIPTION DRUG Fiorinal Butalbital, Aspirin, and Caffeine CAPSULE ORAL 19760504 NDA NDA017534 Watson Pharma, Inc. ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 52544-956_396b5a96-0e06-47d0-9889-0a65dbe53499 52544-956 HUMAN PRESCRIPTION DRUG Fiorinal with Codeine Butalbital, Aspirin, Caffeine, and Codeine Phosphate CAPSULE ORAL 19901026 NDA NDA019429 Watson Pharma, Inc. ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 52544-957_4349cc7e-cb31-4591-be30-8d90b7cd0bdc 52544-957 HUMAN PRESCRIPTION DRUG Fioricet Butalbital, Acetaminophen, and Caffeine TABLET ORAL 19841109 20161130 ANDA ANDA088616 Watson Pharma, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 52544-958_18ee437a-efa3-46cd-bb6c-6d784e15654c 52544-958 HUMAN PRESCRIPTION DRUG Fioricet with Codeine butalbital, acetaminophen, caffeine, and codeine phosphate CAPSULE ORAL 19920730 NDA NDA020232 Watson Pharma, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 52544-959_7c64f69f-9a44-47fb-a4cf-6d2a3f9959c9 52544-959 HUMAN PRESCRIPTION DRUG Caziant desogestrel and ethinyl estradiol KIT 20050501 ANDA ANDA077182 Watson Pharma, Inc. 52544-966_700d3a1a-d9f9-4b5b-9910-6ad520680a63 52544-966 HUMAN PRESCRIPTION DRUG Quasense Levonorgestrel and Ethinyl Estradiol KIT ORAL 20060906 ANDA ANDA077101 Watson Pharma, Inc. 52544-967_92c9a1b4-2b71-421a-8fec-270de0ac2966 52544-967 HUMAN PRESCRIPTION DRUG Sronyx Levonorgestrel and Ethinyl Estradiol KIT 20060531 ANDA ANDA077681 Watson Pharma, Inc. 52544-981_7e982cbe-80c5-4a16-8077-25bf915cb718 52544-981 HUMAN PRESCRIPTION DRUG Zarah Drospirenone and Ethinyl Estradiol KIT ORAL 20100907 ANDA ANDA090081 Watson Pharma, Inc. 52544-982_f7226427-ee74-4ec8-85db-437fe9d86dab 52544-982 HUMAN PRESCRIPTION DRUG Vestura Drospirenone and Ethinyl Estradiol KIT ORAL 20120119 ANDA ANDA078833 Watson Pharma, Inc. 52545-505_5012f4c7-4cce-4e4d-aa54-a6faa67ddde8 52545-505 HUMAN OTC DRUG Optisource Foam Antibacterial Skin Cleanser Triclosan SOAP TOPICAL 20060901 OTC MONOGRAPH NOT FINAL part333 Wausau Paper Towel & Tissue, LLC TRICLOSAN .3 mg/100mL 52545-700_b3e20318-b5d7-4392-8054-3fbcd061389b 52545-700 HUMAN OTC DRUG Bay West E2 Antibacterial Skin Cleanser Chloroxylenol SOAP TOPICAL 20061001 OTC MONOGRAPH NOT FINAL part333E Wausau Paper Towel & Tissue, LLC CHLOROXYLENOL .3 mg/100mL 52546-100_18cf4720-ab4c-4b0e-9391-71e86ae53dd9 52546-100 HUMAN OTC DRUG Smith and Johnson Antibacterial TRICLOSAN LIQUID TOPICAL 20100621 OTC MONOGRAPH NOT FINAL part333 Allied International Corp TRICLOSAN .115 mL/100mL 52546-110_f9685c0b-c691-438c-b1c3-73cb1348418d 52546-110 HUMAN OTC DRUG Smith and Johnson Antibacterial TRICLOSAN SOAP TOPICAL 20110519 OTC MONOGRAPH FINAL part333E Allied International Corp TRICLOSAN .115 mL/100mL 52549-2106_5ce3ebe2-4297-4a70-b32f-cdd74c462e49 52549-2106 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Taro Pharmaceutical Industries, Ltd. CETIRIZINE HYDROCHLORIDE 1 mg/mL 52549-4118_96620eda-0669-4a7b-96ac-40206379d659 52549-4118 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil CREAM TOPICAL 20100305 ANDA ANDA090368 Taro Pharmaceutical Industries Ltd. FLUOROURACIL 50 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 52549-4145_2f2c5005-250a-452f-a8d2-05a505a0fb27 52549-4145 HUMAN PRESCRIPTION DRUG Imiquimod Imiquimod CREAM TOPICAL 20110415 ANDA ANDA200173 Taro Pharmaceutical Industries Ltd. IMIQUIMOD 50 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 52549-4147_a1a2d874-5b9c-4f21-bb21-8757f2468b2a 52549-4147 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20110523 ANDA ANDA200998 Taro Pharmaceutical Industries Ltd. MEPROBAMATE 200 mg/1 CIV 52549-4148_a1a2d874-5b9c-4f21-bb21-8757f2468b2a 52549-4148 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20110523 ANDA ANDA200998 Taro Pharmaceutical Industries Ltd. MEPROBAMATE 400 mg/1 CIV 52553-001_873511a4-3a3f-4e29-bdcc-2dceae8d3229 52553-001 HUMAN OTC DRUG Smart Sense Isopropyl Alcohol Wipes Alcohol Wipe CLOTH TOPICAL 20110801 OTC MONOGRAPH FINAL part344 US Nonwovens ISOPROPYL ALCOHOL .7 mL/mL 52553-002_85ded830-f5aa-4b86-a876-4c0470efbc25 52553-002 HUMAN OTC DRUG SMART SENSE Hydrogen Peroxide Hydrogen Peroxide CLOTH TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333A US Nonwovens HYDROGEN PEROXIDE .03 mL/mL 52554-1001_ad7e144f-288c-4513-86f1-c9d82bd80359 52554-1001 HUMAN OTC DRUG MediSpa Sunblock sunblock zinc oxide CREAM TOPICAL 20100804 UNAPPROVED DRUG OTHER Universal Cosmetic Co., Ltd AVOBENZONE; ENZACAMENE; OCTINOXATE; ZINC OXIDE .005; .03; .07; .05 mL/mL; mL/mL; mL/mL; mL/mL 52554-2001_7dd4f01c-7789-46a4-8617-c0782e79ccdf 52554-2001 HUMAN OTC DRUG MediSpa SunSpray sunblock OCTINOXATE SPRAY TOPICAL 20100806 UNAPPROVED DRUG OTHER Universal Cosmetic Co., Ltd ENZACAMENE; OCTINOXATE; OCTOCRYLENE .05; .075; .01 mL/mL; mL/mL; mL/mL 52554-3001_eed3377a-26c2-4e93-95c4-7f10712d90be 52554-3001 HUMAN OTC DRUG Laser Block 100 sunblock OCTINOXATE CREAM TOPICAL 20100804 UNAPPROVED DRUG OTHER Universal Cosmetic Co., Ltd AMILOXATE; AVOBENZONE; ENZACAMENE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .02; .005; .03; .07; .02; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 52554-4001_d522a805-d802-47e6-add2-fa06428a062a 52554-4001 HUMAN OTC DRUG Derma Blemish Balm blemish balm adenosine CREAM TOPICAL 20100805 UNAPPROVED DRUG OTHER Universal Cosmetic Co., Ltd ADENOSINE; ARBUTIN; TITANIUM DIOXIDE .0004; .02; .06 mL/mL; mL/mL; mL/mL 52554-5001_ec0c2126-a7fa-448e-8805-21b2da0de858 52554-5001 HUMAN OTC DRUG Laser Rejuvenation restoring damage skin adenosine CREAM TOPICAL 20100819 UNAPPROVED DRUG OTHER Universal Cosmetic Co., Ltd ACETYL HEXAPEPTIDE-3; ADENOSINE; CENTELLA ASIATICA .0001; .00004; .001 mL/mL; mL/mL; mL/mL 52557-103_dec8a153-656f-4dc9-a48b-107e8ca65e1b 52557-103 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100625 UNAPPROVED MEDICAL GAS CornerStone Medical Services-Midwest LLC OXYGEN .99 L/L 52559-575_37fb3e69-4cd9-431e-bc00-3878f091565a 52559-575 HUMAN OTC DRUG Anchor Foaming Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part333E Anchor Supply Company BENZETHONIUM CHLORIDE 2 mg/mL 52559-576_10d46c68-6a44-44a1-bf7a-b357f2b8aec7 52559-576 HUMAN OTC DRUG Anchor Foaming Mango TRICLOSAN SOAP TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part333E Anchor Supply Company TRICLOSAN .003 mL/mL 52564-308_c9728518-f3f5-4563-b6dd-e49349a03934 52564-308 HUMAN OTC DRUG Hot Stuff Cream Capsaicin CREAM TOPICAL 20140625 OTC MONOGRAPH NOT FINAL part348 Mueller Sports Medicine, Inc. CAPSAICIN .265 g/106g 52564-312_e68bdd30-eda1-4015-a13d-ef85769ddb1a 52564-312 HUMAN OTC DRUG Muellergesic Cream Menthol and Camphor (Synthetic) CREAM TOPICAL 20140625 OTC MONOGRAPH NOT FINAL part348 Mueller Sports Medicine, Inc. CAMPHOR (SYNTHETIC); MENTHOL 6.3; 12.72 g/106g; g/106g 52564-330_28ca4810-0b8c-4219-b026-f2066f153706 52564-330 HUMAN OTC DRUG Mueller First Aid Antiseptic Benzalkonium chloride, Lidocaine hydrochloride SPRAY TOPICAL 20130816 OTC MONOGRAPH NOT FINAL part348 Mueller Sports Medicine, Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .13; 2 g/100mL; g/100mL 52564-340_f6019888-a8fe-4aa8-ad9d-0271b2ca1e82 52564-340 HUMAN OTC DRUG Mueller Super Suds Benzalkonium Chloride LOTION TOPICAL 20140523 OTC MONOGRAPH NOT FINAL part333A Mueller Sports Medicine, Inc. BENZALKONIUM CHLORIDE .13 mg/mL 52564-460_6e5f407f-bc79-41cc-8dce-302fbb496e65 52564-460 HUMAN OTC DRUG Mueller Instant Hand Sanitizer alcohol LIQUID TOPICAL 20100205 OTC MONOGRAPH NOT FINAL part333E Mueller Sports Medicine, Inc. ALCOHOL 62 mL/100mL 52565-009_a4c3918a-3f48-4857-95cf-c30e4de0b59b 52565-009 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION TOPICAL 20140318 ANDA ANDA204494 IGI Labs, Inc. LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52565-012_8c57c797-b7c0-416f-ab41-d1f9b702898f 52565-012 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide SOLUTION TOPICAL 20121127 NDA AUTHORIZED GENERIC NDA015296 IGI Labs, Inc. FLUOCINOLONE ACETONIDE .1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52565-013_1e719f33-4bc4-4fce-b970-a55c9e3d1ffa 52565-013 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OINTMENT TOPICAL 20121227 NDA AUTHORIZED GENERIC NDA013960 IGI Labs, Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52565-020_c949d40a-3541-4af3-9a20-ef1527444dd0 52565-020 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide CREAM TOPICAL 20121228 NDA AUTHORIZED GENERIC NDA012787 IGI Labs, Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52565-022_c8e3f16c-e022-45a9-8485-171022858eb1 52565-022 HUMAN PRESCRIPTION DRUG Econazole Nitrate Econazole Nitrate CREAM TOPICAL 20130801 ANDA ANDA076574 IGI labs, Inc. ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 52565-031_c949d40a-3541-4af3-9a20-ef1527444dd0 52565-031 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide CREAM TOPICAL 20140515 NDA AUTHORIZED GENERIC NDA012787 IGI Labs, Inc. FLUOCINOLONE ACETONIDE .1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52567-001_5b94b6fe-26da-7b51-1645-c02b62ff6ef2 52567-001 HUMAN OTC DRUG Brioschi Effervescent Antacid sodium bicarbonate, tartaric acid GRANULE, EFFERVESCENT ORAL 20100920 OTC MONOGRAPH FINAL part331 Brioschi Pharmaceuticals International, LLC SODIUM BICARBONATE; TARTARIC ACID 1.8; 1.63 g/6g; g/6g 52567-124_1d0923f5-1bcf-a4eb-54ab-84b0f047f071 52567-124 HUMAN OTC DRUG Gingera Effervescent Antacid sodium bicarbonate, tartaric acid GRANULE, EFFERVESCENT ORAL 20110429 OTC MONOGRAPH FINAL part331 Brioschi Pharmaceuticals International, LLC SODIUM BICARBONATE; TARTARIC ACID 1.8; 1.62 g/6g; g/6g 52567-125_acd5b757-ee63-684c-0959-e02de6175b4a 52567-125 HUMAN OTC DRUG Brioschi Childrens Effervescent Antacid sodium bicarbonate, tartaric acid GRANULE, EFFERVESCENT ORAL 20110427 OTC MONOGRAPH FINAL part331 Brioschi Pharmaceuticals International, LLC SODIUM BICARBONATE; TARTARIC ACID 1.17; 1.05 g/4g; g/4g 52568-001_662cbb39-e585-4592-914c-28bbac6ceec0 52568-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Crumpton Welding Supply & Equipment, Inc OXYGEN 99 L/100L 52568-002_52843a4e-a554-47fa-a1ed-c6362e6ed13e 52568-002 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Crumpton Welding Supply & Equipment, Inc NITROUS OXIDE 99 L/100L 52568-006_ea796fb3-d0fd-4a67-9ea0-0fafcb9aceeb 52568-006 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Crumpton Welding Supply & Equipment, Inc NITROGEN 99 L/100L 52568-007_3c568358-f5e8-4b6c-bdf1-bfe76c472a14 52568-007 HUMAN PRESCRIPTION DRUG AIR COMPRESSED AIR COMPRESSED GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Crumpton Welding Supply & Equipment, Inc OXYGEN 20 L/100L 52579-1600_ef3ae09c-c3da-42c2-aa06-ee1ee7967b18 52579-1600 HUMAN PRESCRIPTION DRUG Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) tilmanocept KIT 20130313 NDA NDA202207 Navidea Biopharmaceuticals, Inc. 52584-001_47c25a0e-3824-4299-8f2f-5e503ae7477e 52584-001 HUMAN PRESCRIPTION DRUG Ephinephrine Ephinephrine INJECTION, SOLUTION INTRAVENOUS 20100801 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52584-002_4ce8d8a7-1bab-4063-952f-f000c35a6026 52584-002 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100801 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52584-003_e3b5a473-c96b-4ab9-b02e-17328f6ac486 52584-003 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride INJECTION INTRAVENOUS 20100801 ANDA ANDA075792 General Injectables & Vaccines, Inc PROPRANOLOL HYDROCHLORIDE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52584-004_fa75595b-5827-48aa-bf6d-6312dfd79735 52584-004 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION INTRAVENOUS 20100801 NDA NDA020800 General Injectables & Vaccines, Inc EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52584-005_67758ee3-1c83-4cc3-9e64-2c5e8617b264 52584-005 HUMAN PRESCRIPTION DRUG Thiamine Hydrochloride Thiamine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100901 ANDA ANDA080556 General Injectables & Vaccines, Inc THIAMINE HYDROCHLORIDE 100 mg/mL 52584-006_e5165d46-d0f9-4005-a4fb-73d80b1c6383 52584-006 HUMAN PRESCRIPTION DRUG CLINDAMYCIN clindamycin INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100103 ANDA ANDA062800 General Injectables & Vaccines, Inc CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 52584-007_1154e4ca-9213-48d6-a19b-5fa1b47c80a3 52584-007 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine INJECTION, SOLUTION INTRAMUSCULAR 20100301 ANDA ANDA087408 General Injectables & Vaccines, Inc HYDROXYZINE HYDROCHLORIDE 50 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 52584-008_b29859dd-6ac8-44a4-b2d2-a0459583bb72 52584-008 HUMAN PRESCRIPTION DRUG Dopamine Dopamine INJECTION, SOLUTION INTRAVENOUS 20100401 ANDA ANDA070820 General Injectables & Vaccines, Inc DOPAMINE HYDROCHLORIDE 80 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52584-009_1f588387-49e8-497b-afc7-578ec2fbebf8 52584-009 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100301 NDA NDA017558 General Injectables & Vaccines, Inc GLYCOPYRROLATE .2 mg/mL 52584-010_1f111d10-e721-434e-bfa0-7e755df0003b 52584-010 HUMAN PRESCRIPTION DRUG Gentamicin Gentamicin Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100901 ANDA ANDA062366 General Injectables & Vaccines, Inc GENTAMICIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 52584-011_ce5440a5-315e-4ad1-a156-c169504b987b 52584-011 HUMAN PRESCRIPTION DRUG Chloramphenicol Sodium Succinate Chloramphenicol Sodium Succinate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100901 ANDA ANDA062365 General Injectables and Vaccines, Inc CHLORAMPHENICOL SODIUM SUCCINATE 133.27 mg/133.27mg Amphenicol-class Antibacterial [EPC],Amphenicols [Chemical/Ingredient] 52584-012_06339631-f99e-4592-b0d3-04eb161784d9 52584-012 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 20100901 ANDA ANDA086283 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-013_165c5def-7403-4578-bbbf-07cee084e074 52584-013 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 20100901 ANDA ANDA086283 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-014_b6dd8722-d704-4678-b96c-cd3cb027ca2f 52584-014 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin POWDER INTRAMUSCULAR; INTRAVENOUS 20100701 ANDA ANDA065395 General Injectables & Vaccines, Inc CEFAZOLIN SODIUM 1 g/g Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52584-015_5aa31378-e43c-4fbd-a9e7-8722b23b1ea2 52584-015 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 20100801 ANDA ANDA086283 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-016_956c1f00-e273-4115-b655-1d2ebbc75100 52584-016 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100801 UNAPPROVED DRUG OTHER General Injectables & Vaccines PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 52584-017_51b46ecc-9981-4d0f-bfb5-6b003d9c3a0b 52584-017 HUMAN PRESCRIPTION DRUG Esmolol Esmolol INJECTION INTRAVENOUS 20100401 NDA NDA019386 General Injectables & Vaccines, Inc ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52584-018_c0477ee9-dbe4-43d6-bb1a-7976a106589a 52584-018 HUMAN PRESCRIPTION DRUG Claforan Cefotaxime Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 20120607 NDA NDA050547 General Injectables & Vaccines, Inc CEFOTAXIME SODIUM 1 g/g Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52584-019_f862489c-5378-4dcc-8a26-ee2d0d6e692c 52584-019 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100701 UNAPPROVED DRUG OTHER GENERAL INJECTABLES AND VACCINES, INC. EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52584-020_8ebcc433-5493-4dae-86e9-256410d1a236 52584-020 HUMAN PRESCRIPTION DRUG VASOPRESSIN argipressin INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20100801 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc ARGIPRESSIN 20 [USP'U]/mL 52584-021_5da5dafb-f27a-4033-843b-10481011f44c 52584-021 HUMAN PRESCRIPTION DRUG Isuprel Isuprel INJECTION, SOLUTION INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100301 NDA NDA010515 General Injectables & Vaccines, Inc ISOPROTERENOL HYDROCHLORIDE .2 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 52584-022_0a7346b8-e911-40bf-a321-99f2f9690a48 52584-022 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION, SOLUTION INTRAVENOUS 20110726 ANDA ANDA077071 General Injectables & Vaccines, Inc FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 52584-023_baafcd21-f68a-4fd4-b1ab-2a263057d1de 52584-023 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110907 ANDA ANDA065226 General Injectables & Vaccines, Inc CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52584-024_15d3eeb9-822a-4035-a227-601e4f66b380 52584-024 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120412 ANDA ANDA062831 General Injectables & Vaccines, Inc CEFAZOLIN SODIUM 500 mg/500mg Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52584-025_8efb19d8-82e0-45db-8c86-62c916b23504 52584-025 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20111026 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc SODIUM CHLORIDE 234 mg/30mL 52584-026_8dfa68e9-e80c-4ee6-9c28-adb9d1a04ae4 52584-026 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20111005 ANDA ANDA078076 General Injectables & Vaccines, Inc ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 52584-027_3db9db72-c2cc-47a5-bb03-58177c6752d4 52584-027 HUMAN PRESCRIPTION DRUG Sterile Water Water SOLUTION INTRAVENOUS 20100901 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc WATER 5 mL/5mL 52584-028_cea1e05d-06e5-47f4-b0a8-6fb91ce4e3b0 52584-028 HUMAN PRESCRIPTION DRUG Doxy 100 Doxycycline Hyclate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120222 ANDA ANDA062475 General Injectables & Vaccines, Inc DOXYCYCLINE HYCLATE 100 mg/100mg 52584-029_f7aa80fe-40ed-4190-96ae-08a1213c2a91 52584-029 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20120508 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc ATROPINE SULFATE .4 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52584-030_fbdc85e3-d5ea-4a5f-8b48-0e20b461b36e 52584-030 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 20120612 ANDA ANDA086283 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-031_6f7e1ea4-79ff-4f54-9890-175e1806c8c8 52584-031 HUMAN PRESCRIPTION DRUG Mannitol Mannitol INJECTION, SOLUTION INTRAVENOUS 20100801 ANDA ANDA016269 General Injectables & Vaccines, Inc MANNITOL 250 mg/mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 52584-032_23bed19d-e5a9-4c36-a6e8-7d71b26bd144 52584-032 HUMAN PRESCRIPTION DRUG Cyanocobalamin Cyanocobalamin INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20100301 ANDA ANDA080737 General Injectables & Vaccines, Inc CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 52584-034_3a5baabf-56e0-4f5d-983b-395aa681b020 52584-034 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 20120530 ANDA ANDA086283 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-035_5a4992a4-6ba8-46cb-84c7-600ed9f9fefc 52584-035 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride lidocaine hydrochloride JELLY TOPICAL 20120828 ANDA ANDA086283 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-036_f807e01b-d11c-49a5-bbd0-fcc5f7df7879 52584-036 HUMAN PRESCRIPTION DRUG NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTION PARENTERAL 20120829 ANDA ANDA072076 General Injectables & Vaccines, Inc NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 52584-037_a24e523d-79f2-471b-9684-db7edf8f4017 52584-037 HUMAN PRESCRIPTION DRUG KETALAR ketamine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20121017 NDA NDA016812 General Injectables & Vaccines, Inc KETAMINE HYDROCHLORIDE 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII 52584-038_b96de664-6654-4bb6-9891-37a646c751a1 52584-038 HUMAN PRESCRIPTION DRUG KETAMINE HYDROCHLORIDE ketamine hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAMUSCULAR; INTRAVENOUS 20121011 ANDA ANDA074549 General Injectables & Vaccines, Inc KETAMINE HYDROCHLORIDE 50 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII 52584-039_e5924680-8f9b-4ca9-b907-3b01f6a03a4b 52584-039 HUMAN PRESCRIPTION DRUG Solu-Medrol Methylprednisolone Sodium Succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100401 NDA NDA011856 General Injectables & Vaccines, Inc METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52584-040_0da4505f-0df2-4f01-8d8b-a2e4491ebfb5 52584-040 HUMAN PRESCRIPTION DRUG KETAMINE HYDROCHLORIDE ketamine hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAMUSCULAR; INTRAVENOUS 20121016 ANDA ANDA074549 General Injectables & Vaccines, Inc KETAMINE HYDROCHLORIDE 100 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII 52584-041_0d5ee30f-81b8-4939-b1d1-e5febd961606 52584-041 HUMAN PRESCRIPTION DRUG DROPERIDOL droperidol INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121018 ANDA ANDA072123 General Injectables & Vaccines, Inc DROPERIDOL 2.5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 52584-042_494758ba-dda1-43db-bea6-52a6cecce4c9 52584-042 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride and Epinephrine Bupivacaine Hydrochloride and Epinephrine INJECTION EPIDURAL; INFILTRATION; INTRACAUDAL 20100701 ANDA ANDA071165 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52584-043_290c611a-7738-4d11-a8cb-f869441be0ae 52584-043 HUMAN PRESCRIPTION DRUG PHYTONADIONE phytonadione INJECTION, EMULSION PARENTERAL 20130213 ANDA ANDA083722 General Injectables & Vaccines, Inc PHYTONADIONE 1 mg/.5mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 52584-044_44e369e2-b969-436d-bfe2-9225336d8c65 52584-044 HUMAN PRESCRIPTION DRUG ATROPINE SULFATE atropine sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20130919 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc ATROPINE SULFATE 1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52584-045_8a97a813-29bb-44d6-b472-5ac817f7e9b4 52584-045 HUMAN PRESCRIPTION DRUG FLUMAZENIL flumazenil INJECTION, SOLUTION INTRAVENOUS 20130313 ANDA ANDA078595 General Injectables & Vaccines, Inc FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 52584-046_26a1939e-e878-4dd1-9e34-17e88f9e6135 52584-046 HUMAN PRESCRIPTION DRUG PHYTONADIONE phytonadione INJECTION, EMULSION PARENTERAL 20140106 ANDA ANDA083722 General Injectables & Vaccines, Inc PHYTONADIONE 1 mg/.5mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 52584-047_e7e76190-259d-418d-900b-df6224318d6f 52584-047 HUMAN PRESCRIPTION DRUG Solu-Medrol Methylprednisolone Sodium Succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100401 NDA NDA011856 General Injectables & Vaccines, Inc METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52584-048_76f921af-c6ae-46b1-b899-cb10e4ab084c 52584-048 HUMAN PRESCRIPTION DRUG Dobutamine Dobutamine Hydrochloride Injection INJECTION, SOLUTION INTRAVENOUS 20141110 ANDA ANDA074292 General Injectables and Vaccines, Inc. DOBUTAMINE HYDROCHLORIDE 12.5 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 52584-050_319db9b0-3d25-4905-81a0-ec92eec7a79e 52584-050 HUMAN PRESCRIPTION DRUG Cortrosyn Cortrosyn INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 20100301 NDA NDA016750 General Injectables & Vaccines, Inc COSYNTROPIN .25 mg/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] 52584-051_57c6ab29-b22d-4770-a5cf-23716e15ebde 52584-051 HUMAN PRESCRIPTION DRUG Dobutamine Hydrochloride Dobutamine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100301 ANDA ANDA074277 General Injectables & Vaccines, Inc DOBUTAMINE HYDROCHLORIDE 12.5 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 52584-052_fac36452-6dc6-431e-b4c5-9b7873f3ed5e 52584-052 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010301 ANDA ANDA075241 General Injectables & Vaccines, Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 52584-053_6094055c-a3ac-44be-9935-5ec5e316723d 52584-053 HUMAN PRESCRIPTION DRUG VASOPRESSIN argipressin INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20100301 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc ARGIPRESSIN 20 [USP'U]/mL 52584-060_a68c1de9-6214-44a4-ba90-3452ef826c35 52584-060 HUMAN PRESCRIPTION DRUG Amidate Etomidate INJECTION, SOLUTION INTRAVENOUS 20100310 NDA NDA018227 General Injectables and Vaccines, Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 52584-061_73e9091a-d37c-4f5f-ad66-91d1cf9e4b5d 52584-061 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100301 ANDA ANDA065047 General Injectables & Vaccines, Inc. CEFAZOLIN SODIUM 500 mg/500mg Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52584-062_3a9dfcb2-cabf-40e8-ab3f-58e2f9f8abd2 52584-062 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride Esmolol Hydrochloride INJECTION INTRAVENOUS 20100801 ANDA ANDA076323 General Injectables & Vaccines, Inc ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52584-066_4412aa4f-8e9f-42f0-8742-dadad685cc66 52584-066 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine INJECTION, SOLUTION EPIDURAL; INFILTRATION 20100401 ANDA ANDA040078 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-071_63cc9a97-89b6-4a45-83c7-967cf46a905c 52584-071 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110902 ANDA ANDA090354 General Injectables & Vaccines, Inc AMPICILLIN SODIUM 500 mg/500mg Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 52584-072_54baf3e9-4461-4d00-b20e-24395fb2ba7d 52584-072 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110907 ANDA ANDA090354 General Injectables & Vaccines, Inc AMPICILLIN SODIUM 1 g/g Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 52584-077_d8e94f3d-ed69-48b0-b27a-191e21c7b3b8 52584-077 HUMAN PRESCRIPTION DRUG Prochlorperazine Edisylate Prochlorperazine Edisylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20100801 ANDA ANDA040540 General Injectables & Vaccines, Inc PROCHLORPERAZINE EDISYLATE 10 mg/2mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52584-085_6db9e349-8a24-4635-b1d4-11668989a595 52584-085 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100801 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc ATROPINE SULFATE .4 mg/.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52584-092_50c67140-0ec6-4a08-9761-33eefc46c893 52584-092 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION INTRAVENOUS 20110218 ANDA ANDA076256 General Injectables & Vaccines, Inc. FLUMAZENIL .5 mg/5mL Benzodiazepine Antagonist [EPC] 52584-093_c2c5daf4-f9e4-4b37-8ba3-6cd65d33523f 52584-093 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION INTRAVENOUS 20110218 ANDA ANDA076256 General Injectables & Vaccines, Inc. FLUMAZENIL 1 mg/10mL Benzodiazepine Antagonist [EPC] 52584-101_979fde04-1357-41e2-88bf-400e1cdaef30 52584-101 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100801 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc ATROPINE SULFATE 1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52584-102_91df9b30-c35a-48ce-a183-5d4001df1baa 52584-102 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 ANDA ANDA018667 General Injectables & Vaccines, Inc FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 52584-104_f16e746c-eb65-4e4b-bf2d-6ec6ec474b4c 52584-104 HUMAN PRESCRIPTION DRUG Dopamine Hydrochloride Dopamine Hydrochloride INJECTION INTRAVENOUS 20100801 NDA NDA018132 General Injectables & Vaccines, Inc DOPAMINE HYDROCHLORIDE 40 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52584-105_98348e18-5d13-41f1-a03e-4d937077b792 52584-105 HUMAN PRESCRIPTION DRUG FLUMAZENIL flumazenil INJECTION, SOLUTION INTRAVENOUS 20130313 ANDA ANDA078595 General Injectables & Vaccines, Inc FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 52584-107_e1e2f5ee-5f51-4b15-b129-8e2c90a73576 52584-107 HUMAN PRESCRIPTION DRUG Robinul Robinul INJECTION INTRAMUSCULAR; INTRAVENOUS 20121011 NDA NDA017558 General Injectables & Vaccines, Inc GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52584-110_208f1141-0dcd-4ccc-83d9-940766a46892 52584-110 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100801 ANDA ANDA062569 General Injectables & Vaccines, Inc DOXYCYCLINE HYCLATE 100 mg/100mg 52584-113_f01cae23-5e1a-4c59-937c-4b868a89b0e0 52584-113 HUMAN PRESCRIPTION DRUG Solu-Medrol Methylprednisolone Sodium Succinate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100901 NDA NDA011856 General Injectables & Vaccines, Inc METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52584-115_cf419147-f04d-4a40-a03d-cca2948e169a 52584-115 HUMAN PRESCRIPTION DRUG Brevibloc Brevibloc INJECTION, SOLUTION INTRAVENOUS 20100701 NDA NDA019386 General Injectables & Vaccines ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52584-119_55c71d10-99d4-4d7f-93ed-42216a219715 52584-119 HUMAN PRESCRIPTION DRUG Tigan Trimethobenzamide Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 20100801 NDA NDA017530 General Injectables & Vaccines, Inc TRIMETHOBENZAMIDE HYDROCHLORIDE 100 mg/mL Antiemetic [EPC],Emesis Suppression [PE] 52584-130_089857bb-8bf7-4c87-8c26-66fb71872292 52584-130 HUMAN PRESCRIPTION DRUG Cyanocobalamin Cyanocobalamin INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20100701 ANDA ANDA080737 General Injectables & Vaccines, Inc CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 52584-135_0d73ada6-738a-425c-808c-ea53d2d3c28b 52584-135 HUMAN PRESCRIPTION DRUG AMPICILLIN ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130313 ANDA ANDA063146 General Injectables & Vaccines, Inc AMPICILLIN SODIUM 500 mg/500mg Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 52584-136_cc39afe1-22b7-461a-808d-2d325194427a 52584-136 HUMAN PRESCRIPTION DRUG AMPICILLIN ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130314 ANDA ANDA062772 General Injectables & Vaccines, Inc AMPICILLIN SODIUM 1 g/g Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 52584-137_e0e95770-9d94-486b-beef-60c3dc52b29d 52584-137 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20100901 ANDA ANDA040302 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-140_6a2057c1-ccf1-4725-8372-b8b2cf52f6c0 52584-140 HUMAN PRESCRIPTION DRUG Phytonadione Phytonadione INJECTION, SOLUTION INTRAMUSCULAR; PARENTERAL; SUBCUTANEOUS 20100401 ANDA ANDA083722 General Injectables & Vaccine, Inc PHYTONADIONE 1 mg/.5mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 52584-142_1e74a0a2-540e-4f09-a56f-f9438683f77e 52584-142 HUMAN PRESCRIPTION DRUG PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride INJECTION INTRAVENOUS 20130402 NDA NDA203826 General Injectables & Vaccines, Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 52584-144_0d0564fb-8a39-4a29-99c6-575d3cc5b187 52584-144 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20100901 ANDA ANDA070737 General Injectables & Vaccines, Inc VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52584-151_739b1fe7-d21c-4892-be6b-6ce64c318710 52584-151 HUMAN PRESCRIPTION DRUG Heparin Lock Flush Heparin Sodium SOLUTION INTRAVENOUS 20100801 NDA NDA005264 General Injectables & Vaccines, Inc HEPARIN SODIUM 10 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52584-152_fc9cd3a3-c354-4205-8399-b0d20c2cf87e 52584-152 HUMAN PRESCRIPTION DRUG Heparin Lock Flush Heparin Sodium SOLUTION INTRAVENOUS 20100801 NDA NDA005264 General Injectables & Vaccines, Inc HEPARIN SODIUM 100 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52584-153_3239c16a-1e1c-4add-9ebd-ce42df55f58f 52584-153 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20120606 ANDA ANDA076217 General Injectables & Vaccines, Inc AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 52584-155_76396f9a-db73-4fb2-8bde-af35e6b442e5 52584-155 HUMAN PRESCRIPTION DRUG Robinul Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 NDA NDA017558 General Injectables & Vaccines, Inc GLYCOPYRROLATE .2 mg/mL 52584-158_76bf36fd-0dab-4169-b42a-4af7c87e55f6 52584-158 HUMAN PRESCRIPTION DRUG Vitamin K1 Phytonadione INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100901 ANDA ANDA087955 General Injectables & Vaccines, Inc PHYTONADIONE 10 mg/mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 52584-160_805e0a76-506b-4115-be97-ae2c902e2bec 52584-160 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION INFILTRATION 20100701 ANDA ANDA070590 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 52584-163_57ee0554-7fc1-4700-9608-6c736ed3b03c 52584-163 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION INFILTRATION 20100701 ANDA ANDA070597 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 52584-165_2d49a8b0-0707-4d58-92c7-d757190fb1a7 52584-165 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS 20110718 ANDA ANDA084916 General Injectables & Vaccines, Inc. DEXAMETHASONE SODIUM PHOSPHATE 4 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52584-168_0df8a69c-0504-45f7-a6a4-662206dbcf08 52584-168 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate Heptahydrate INJECTION INTRAMUSCULAR; INTRAVENOUS 20100901 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL 52584-177_2e9cae59-505d-4e58-a1c8-ca68081af341 52584-177 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine Lidocaine Hydrochloride and Epinephrine INJECTION INFILTRATION 20100801 ANDA ANDA089635 General Injectables & Vaccines, Inc EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 5; 5 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52584-178_0d4dd2e0-634c-4749-a3f3-47650d4122b6 52584-178 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine Lidocaine Hydrochloride and Epinephrine INJECTION INFILTRATION 20100801 ANDA ANDA089644 General Injectables & Vaccines, Inc EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 10 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52584-182_7f849c6b-3320-4fa6-8a43-900f75adad44 52584-182 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine Lidocaine Hydrochloride and Epinephrine INJECTION, SOLUTION INFILTRATION 20100301 ANDA ANDA089646 General Injectables & Vaccines EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 10; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52584-190_eb2f2232-cf3b-4c80-9010-4eb3b45ff8fc 52584-190 HUMAN PRESCRIPTION DRUG Solu-Medrol Methylprednisolone Sodium Succinate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100901 NDA NDA011856 General Injectables & Vaccines, Inc METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52584-196_3414abbe-47c9-483b-81ac-8d19e227ad6f 52584-196 HUMAN PRESCRIPTION DRUG THIAMINE HYDROCHLORIDE thiamine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130821 ANDA ANDA091623 General Injectables & Vaccines, Inc THIAMINE HYDROCHLORIDE 100 mg/mL 52584-201_957328d1-93dc-4a29-8669-7191bd6737f4 52584-201 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine INJECTION, SOLUTION INTRAMUSCULAR 20100301 ANDA ANDA087408 General Injectables & Vaccines, Inc HYDROXYZINE HYDROCHLORIDE 25 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 52584-207_b5a412a8-b3c3-460c-ba4d-d9d95bc26d9d 52584-207 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate INJECTION, SOLUTION, CONCENTRATE INTRAMUSCULAR; INTRAVENOUS 20100801 ANDA ANDA062420 General Injectables & Vaccines, Inc GENTAMICIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 52584-213_8debf3ca-d95d-4376-a18e-e44c0017878a 52584-213 HUMAN PRESCRIPTION DRUG Diazepam Diazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100501 ANDA ANDA071583 General Injectables and Vaccines, Inc. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52584-215_f49dfc37-c557-441e-9158-f3dced26a677 52584-215 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100801 ANDA ANDA070256 General Injectables & Vaccines, Inc NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 52584-240_357e16d3-61a6-4d25-a423-f014c45fc309 52584-240 HUMAN PRESCRIPTION DRUG Phytonadione Phytonadione INJECTION, EMULSION PARENTERAL 20120914 ANDA ANDA083722 General Injectables & Vaccines, Inc PHYTONADIONE 1 mg/.5mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 52584-241_2b788632-f5e1-4b2b-8594-1d6b0f99e4d6 52584-241 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20100301 NDA NDA020800 General Injectables & Vaccines, Inc EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52584-250_f662f307-0aa8-4457-8b16-87739146d894 52584-250 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100401 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc ATROPINE SULFATE .4 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52584-262_9007d39c-92ba-4d5e-adc4-4ed583d02b11 52584-262 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100801 NDA NDA017029 General Injectables & Vaccines, Inc HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52584-269_124655f0-aa63-416c-9348-c77bf4cb22ce 52584-269 HUMAN PRESCRIPTION DRUG Diprivan Diprivan INJECTION, EMULSION INTRAVENOUS 20100301 NDA NDA019627 General Injectables & Vaccines, Inc PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 52584-273_c904d01c-6f4a-468d-864d-4d944e2f8a50 52584-273 HUMAN PRESCRIPTION DRUG Diazepam Diazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 20100601 ANDA ANDA072079 General Injectables and Vaccines, Inc. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52584-275_943a4dfc-5799-4cb7-b4c2-b8f22b2b9e2a 52584-275 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride Anhydrous INJECTION, SOLUTION INFILTRATION 20100901 ANDA ANDA088325 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE ANHYDROUS 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-276_47612162-8efc-494a-bf58-637ba6fb83e1 52584-276 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride Anhydrous INJECTION, SOLUTION INFILTRATION 20100901 ANDA ANDA088299 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-277_599a1a96-9013-4e08-98e8-259c21b3725d 52584-277 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride Anhydrous INJECTION, SOLUTION INFILTRATION 20100901 ANDA ANDA088327 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-282_ed8b2c08-21ea-4a0e-8f5d-b02e60346a3e 52584-282 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine INJECTION, SOLUTION EPIDURAL; INFILTRATION 20100401 ANDA ANDA088294 General Injectables & Vaccines LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-285_d426dbd2-ccf9-4113-97b1-b213d2ea997b 52584-285 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 20100801 ANDA ANDA075160 General Injectables & Vaccines, Inc METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52584-286_aec6c7f3-9972-40bc-bdf7-2c299dfeec85 52584-286 HUMAN PRESCRIPTION DRUG NAROPIN ropivacaine hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20140311 NDA NDA020533 General Injectables & Vaccines, Inc ROPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 52584-290_b5413316-b2db-49cd-ac98-81f52f58ef4e 52584-290 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100301 ANDA ANDA040140 General Injectables and Vaccines DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 52584-299_e3722416-6a02-4eaa-a972-84dc4dd76db1 52584-299 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20120125 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 52584-301_346abca3-f76b-4350-b2d2-831c282c907f 52584-301 HUMAN PRESCRIPTION DRUG ADENOSINE adenosine INJECTION INTRAVENOUS 20140326 ANDA ANDA078686 General Injectables & Vaccines, Inc ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 52584-302_1e137373-bd30-4d71-ac04-a776c27d4256 52584-302 HUMAN PRESCRIPTION DRUG VASOPRESSIN vasopressin INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20131217 UNAPPROVED DRUG OTHER Feneral Injectables & Vaccines, Inc VASOPRESSIN 20 [USP'U]/mL 52584-308_7446426c-2757-4860-a974-8021de63b17d 52584-308 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20100801 ANDA ANDA075857 General Injectables & Vaccines, Inc MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52584-310_f95f7ab1-e394-4101-bf84-9b7b043de120 52584-310 HUMAN PRESCRIPTION DRUG Methylene Blue Methylene Blue INJECTION, SOLUTION INTRAVENOUS 20101217 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc. METHYLENE BLUE 10 mg/mL 52584-311_99101668-d23c-40ca-98f0-3cba6295c82a 52584-311 HUMAN PRESCRIPTION DRUG Calcium Gluconate Calcium Gluconate INJECTION, SOLUTION INTRAVENOUS 20100801 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc CALCIUM GLUCONATE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 52584-317_3a2ace9c-d4ca-4073-a028-fddd859d8d7e 52584-317 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 ANDA ANDA089521 General Injectables & Vaccines, Inc PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52584-321_e9c439f3-0388-4c3c-ac9c-44c3d747df1a 52584-321 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION, SOLUTION INTRAVENOUS 20100301 ANDA ANDA076787 General Injectables & Vaccines, Inc FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 52584-323_190bc3d0-ce79-4c38-ac15-90eb11194b3a 52584-323 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20100901 ANDA ANDA040302 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-332_6063935c-23a9-4b08-a215-d5826f9cc55e 52584-332 HUMAN PRESCRIPTION DRUG Sterile Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100901 ANDA ANDA062911 General Injectables & Vaccines, Inc VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 52584-348_5ff1c789-fd08-427c-8829-0dec30233412 52584-348 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100301 ANDA ANDA075955 General Injectables & Vaccines, Inc. AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 52584-369_7e57c030-51f0-429d-8f32-15cdf6e66a0f 52584-369 HUMAN PRESCRIPTION DRUG NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20140507 ANDA ANDA072076 General Injectables & Vaccines, Inc. NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 52584-376_b73a80eb-4cc8-4802-b816-c33a0e17143e 52584-376 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100701 ANDA ANDA080817 General Injectables & Vaccines, Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 52584-389_ee51e2b6-cfff-4b57-a496-95eeb876b859 52584-389 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100401 ANDA ANDA062719 General Injectables & Vaccines, Inc AMPICILLIN SODIUM 1 g/g Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 52584-400_dbe9c432-fa27-4436-85d9-7d56753f451b 52584-400 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20110913 ANDA ANDA090808 General Injectables & Vaccines, Inc HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52584-401_0720434a-6dba-451c-ad25-f6d6be3af49f 52584-401 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100401 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc ATROPINE SULFATE .4 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52584-402_4bc72531-bef9-4dbb-ad73-4db8e5b76d6f 52584-402 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20110913 ANDA ANDA090808 General Injectables & Vaccines, Inc HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52584-410_f60adf1e-f31c-4afc-bf2a-ec564134ddd0 52584-410 HUMAN PRESCRIPTION DRUG Digoxin Digoxin INJECTION INTRAMUSCULAR; INTRAVENOUS 20100701 ANDA ANDA083391 General Injecatables & Vaccines, Inc DIGOXIN 250 ug/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 52584-411_04af3f0a-ab60-458b-911d-5898af48c61b 52584-411 HUMAN PRESCRIPTION DRUG ISOVUE-M 200 Iopamidol INJECTION, SOLUTION INTRATHECAL 20101105 NDA NDA018735 General Injectables & Vaccines, Inc. IOPAMIDOL 408 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 52584-414_4ff62e7f-9fc2-4952-b675-a01dde4c10db 52584-414 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100501 NDA NDA073118 General Injectables & Vaccines, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/2mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 52584-418_b443c6e9-ff26-4c0a-b159-0fd25430276d 52584-418 HUMAN PRESCRIPTION DRUG NITROSTAT nitroglycerin TABLET ORAL 20100301 NDA NDA021134 General Injectables & Vaccines, Inc NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 52584-443_0d7e317c-ad9b-4491-bbf0-3ac1b6b06f26 52584-443 HUMAN PRESCRIPTION DRUG Levophed Norepinephrine Bitartrate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100301 NDA NDA007513 General Injectables & Vaccines, Inc NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52584-450_610f1866-3a91-4cac-a660-7e832af8c387 52584-450 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 NDA NDA017862 General Injectables & Vaccines, Inc METOCLOPRAMIDE HYDROCHLORIDE 10 mg/2mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 52584-451_3f572c00-d550-4e52-8898-4a7c0880aba4 52584-451 HUMAN PRESCRIPTION DRUG Reglan Metoclopramide Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 NDA NDA017862 General Injectables & Vaccines, Inc METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 52584-463_903ebc4c-80d0-4bec-ad7b-d2cc1d896ce4 52584-463 HUMAN PRESCRIPTION DRUG Nalbuphine Hydrochloride Nalbuphine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100301 ANDA ANDA070914 General Injectables & Vaccines, Inc NALBUPHINE HYDROCHLORIDE 10 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] 52584-465_8f8b00b2-3ffe-42b0-8635-6c90aba5581f 52584-465 HUMAN PRESCRIPTION DRUG Sensorcaine Bupivacaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20111017 ANDA ANDA018304 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 52584-466_d55baf1a-ab20-4b94-a129-a1952a239571 52584-466 HUMAN PRESCRIPTION DRUG Sensorcaine MPF bupivacaine hydrochloride INJECTION, SOLUTION EPIDURAL; INTRACAUDAL; PERINEURAL 20111026 ANDA ANDA070553 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 52584-467_7db41f3f-8e12-48cd-8c82-d2bd11593dda 52584-467 HUMAN PRESCRIPTION DRUG Sensorcaine Bupivacaine Hydrochloride INJECTION, SOLUTION PERINEURAL 20111018 ANDA ANDA018304 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 52584-469_b0cd3762-ad86-42ce-8995-4ec68f3a09a6 52584-469 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION PARENTERAL 20101227 ANDA ANDA072076 General Injectables & Vaccines, Inc. NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 52584-474_568759fb-c1ca-413e-8e71-ccf8992d2e86 52584-474 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol Lactate INJECTION INTRAMUSCULAR 20140929 ANDA ANDA075689 General Injectables and Vaccines, Inc HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] 52584-475_f84d6e9b-15e6-408b-b36b-a196a3a8465a 52584-475 HUMAN PRESCRIPTION DRUG Nesacaine Chloroprocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20111003 NDA NDA009435 General Injectables & Vaccines, Inc CHLOROPROCAINE HYDROCHLORIDE 10 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 52584-476_5d9830da-eb0d-4b42-a246-74306283a371 52584-476 HUMAN PRESCRIPTION DRUG NESACAINE chloroprocaine hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20130130 NDA NDA009435 General Injectables & Vaccines, Inc CHLOROPROCAINE HYDROCHLORIDE 20 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 52584-481_5ef0b321-4df4-4fd6-8909-7034eb17a0a4 52584-481 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine hydrochloride, epinephrine bitartrate injection, solution INJECTION, SOLUTION INFILTRATION; PERINEURAL 20110928 NDA NDA006488 General Injectables & Vaccines, Inc EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .005; 5 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52584-482_49818470-7b3c-4898-b184-a439e4fc2a6c 52584-482 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride and Epinephrine INJECTION, SOLUTION INFILTRATION; PERINEURAL 20110912 NDA NDA006488 General Injectables & Vaccines, Inc EPINEPHRINE; LIDOCAINE HYDROCHLORIDE .01; 10 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52584-483_f90e3fb5-54ef-462d-bf35-995cdc89631c 52584-483 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride and epinephrine INJECTION, SOLUTION INFILTRATION; PERINEURAL 20111103 NDA NDA006488 General Injectables & Vaccines, Inc EPINEPHRINE; LIDOCAINE HYDROCHLORIDE .01; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52584-484_8ed37464-ef48-4900-b233-092cf9e6a810 52584-484 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20110921 NDA NDA006488 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-485_e15c4e91-ad5c-401c-bb13-7967b507ffea 52584-485 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20110926 NDA NDA006488 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-485_eae3aea0-65c9-43b2-83b2-5245950de689 52584-485 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20111025 NDA NDA006488 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-486_6007dd23-351b-4e56-9b53-6ce07e5103a6 52584-486 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine HCl INJECTION, SOLUTION INFILTRATION; PERINEURAL 20111109 NDA NDA006488 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-489_cdffd011-28b6-4531-acdf-db41043e7b5e 52584-489 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride and epinephrine INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20110927 NDA NDA006488 General Injectables & Vaccines, Inc EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .005; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52584-493_d3d61a74-2e78-4ccb-b0c0-ca4743010d17 52584-493 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100301 ANDA ANDA084307 General Injectables & Vaccines, Inc PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52584-495_636cdddd-c300-4744-ab74-d79bd81a6f25 52584-495 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 ANDA ANDA083312 General Injectables & Vaccines, Inc PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52584-496_afb47f60-b760-4032-986d-7f118d57d64b 52584-496 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 20100801 ANDA ANDA083312 General Injectables & Vaccines, Inc PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52584-503_a2660944-ef2e-4140-b715-590c0e6a7c5e 52584-503 HUMAN PRESCRIPTION DRUG DEHYDRATED ALCOHOL alcohol INJECTION INTRASPINAL 20140115 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc ALCOHOL .98 mL/mL 52584-504_84793586-a645-4b36-8cad-8cfd2fe38ed0 52584-504 HUMAN PRESCRIPTION DRUG Methylene Blue Methylene Blue INJECTION, SOLUTION INTRAVENOUS 20100401 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc METHYLENE BLUE 10 mg/mL 52584-516_4a39f20d-ea00-42ae-858c-c62238012919 52584-516 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 ANDA ANDA040572 General Injectables & Vaccines, Inc DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52584-517_46909609-6cb4-4482-8cb9-9fc47f68cdeb 52584-517 HUMAN PRESCRIPTION DRUG Dextrose Dextrose Monohydrate INJECTION, SOLUTION INTRAVENOUS 20100701 NDA NDA019445 General Injectables & Vaccines, Inc DEXTROSE MONOHYDRATE .5 g/mL 52584-534_d923ef5a-a505-4fc8-a4ff-cc9f7bd7574b 52584-534 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION, SOLUTION INTRAVENOUS 20100301 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc SODIUM BICARBONATE 42 mg/mL 52584-540_e86e4272-0ed6-4091-ac05-a7c9f62afc66 52584-540 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100801 NDA NDA017029 General Injectables & Vaccines, Inc HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52584-542_b7528bee-f27f-4a00-8e61-6c4dcb9844e5 52584-542 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100301 NDA NDA017029 General Injectables & Vaccines, Inc HEPARIN SODIUM 100000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52584-555_894d6392-250d-44a3-90a1-f3def5bbe76d 52584-555 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110830 ANDA ANDA084307 General Injectables & Vaccines, Inc. PHENYTOIN SODIUM 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52584-556_6b096286-39e4-4a9c-8a71-b0f6c2f9ba7c 52584-556 HUMAN PRESCRIPTION DRUG Kinevac Sincalide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20101105 NDA NDA017697 General Injectables & Vaccines, Inc SINCALIDE 5 ug/5mL Cholecystokinin [Chemical/Ingredient],Cholecystokinin Analog [EPC] 52584-559_3b83cb4a-f97c-47ba-ae37-df4ad2e99399 52584-559 HUMAN PRESCRIPTION DRUG Marcaine Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION 20100801 NDA NDA016964 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 52584-560_04862f0d-7ade-4f8c-b7d3-b66c42520e9e 52584-560 HUMAN PRESCRIPTION DRUG Marcaine Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL 20100801 NDA NDA016964 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 52584-560_4f3467d2-590a-4700-ac88-c8ffc4329ae3 52584-560 HUMAN PRESCRIPTION DRUG Marcaine Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION 20100301 NDA NDA016964 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 52584-569_23bc4bc7-72ae-4311-8d37-f16dda002054 52584-569 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole INJECTION, SOLUTION INTRAVENOUS 20100901 ANDA ANDA074521 General Injectables & Vaccines, Inc DIPYRIDAMOLE 5 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 52584-581_a346962d-4984-46d1-bcb3-0905b9efbcad 52584-581 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100301 NDA NDA005264 General Injectables & Vaccines, Inc HEPARIN SODIUM 10000 [USP'U]/5mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 52584-601_6a0eacbb-0a31-4320-876d-62ec5b5dbc46 52584-601 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine INJECTION, SOLUTION INTRAMUSCULAR 20100301 ANDA ANDA087408 General Injectables & Vaccines, Inc HYDROXYZINE HYDROCHLORIDE 50 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 52584-602_54dc5b33-c3d9-4630-ad33-f703668df960 52584-602 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate Heptahydrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc MAGNESIUM SULFATE HEPTAHYDRATE .5 g/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 52584-605_dc5cb811-aea3-44c2-b334-3768f60d6adf 52584-605 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120220 ANDA ANDA089335 General Injectables & Vaccines, Inc GLYCOPYRROLATE .2 mg/mL 52584-609_9e25ba54-a338-4f6d-9c5c-5b06da17e2e3 52584-609 HUMAN PRESCRIPTION DRUG Neut 4% Sodium Bicarbonate Additive Solution INJECTION INTRAVENOUS 20140731 UNAPPROVED DRUG OTHER General Injectables and Vaccines, Inc SODIUM BICARBONATE .2 g/5mL 52584-610_c3318ac0-0de8-412c-aa2d-4125c8d4f08e 52584-610 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine INJECTION, SOLUTION INTRAMUSCULAR 20100301 ANDA ANDA087408 General Injectables & Vaccines, Inc HYDROXYZINE HYDROCHLORIDE 50 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 52584-614_4c31222b-b500-42ce-9e4f-d4fffefdd852 52584-614 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVASCULAR 20111019 ANDA ANDA040388 General Injectables & Vaccines, Inc HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 52584-625_74f09d47-861f-427c-b279-860393e5bcf1 52584-625 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION, SOLUTION INTRAVENOUS 20100801 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc SODIUM BICARBONATE 1 meq/mL 52584-626_5ea4e758-8d65-4152-850b-ad8c51b2df7a 52584-626 HUMAN PRESCRIPTION DRUG BUTORPHANOL TARTRATE butorphanol tartrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130814 ANDA ANDA074626 General Injectables & Vaccines, Inc BUTORPHANOL TARTRATE 2 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV 52584-630_faa462a1-176c-499c-b279-d092d07c0db4 52584-630 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100301 NDA NDA021146 General Injectables & Vaccines, Inc. ATROPINE SULFATE .05 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52584-631_00ce9f8e-62b4-4a05-acd5-cba477443392 52584-631 HUMAN PRESCRIPTION DRUG Calcium Chloride Calcium Chloride INJECTION, SOLUTION INTRAVENOUS 20100701 NDA NDA021117 General Injectables & Vaccines, Inc CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 52584-633_fc104cc7-abab-495d-946a-aa6d4fc81e02 52584-633 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20100301 ANDA ANDA075136 General Injectables & Vaccines, Inc VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 52584-637_a1b5482b-fe97-4bfe-be33-4c2f21f83177 52584-637 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION, SOLUTION INTRAVENOUS 20100801 ANDA ANDA077394 General Injectables & Vaccines, Inc SODIUM BICARBONATE 1 meq/mL 52584-639_340efa89-1c6e-4e0d-a54d-d835bc4faeef 52584-639 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION, SOLUTION INTRAVENOUS 20100801 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc SODIUM BICARBONATE 44.6 meq/50mL 52584-641_43b701ca-1121-43f6-807a-28c06f01fd88 52584-641 HUMAN PRESCRIPTION DRUG Suprane Desflurane LIQUID RESPIRATORY (INHALATION) 20120425 NDA NDA020118 General Injectables & Vaccines, Inc DESFLURANE 240 mL/240mL General Anesthesia [PE],General Anesthetic [EPC] 52584-648_52103fca-d6eb-4098-81f6-cd53a8c2a945 52584-648 HUMAN PRESCRIPTION DRUG Dextrose Dextrose Monohydrate INJECTION, SOLUTION INTRAVENOUS 20100701 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc DEXTROSE MONOHYDRATE .5 g/mL 52584-652_18e86f06-cbdf-44e0-98de-4211d7a08827 52584-652 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride Esmolol Hydrochloride INJECTION INTRAVENOUS 20120613 ANDA ANDA076573 General Injectables & Vaccines, Inc ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52584-653_99b31e8e-2fe2-42c1-baed-a6961e8382e2 52584-653 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride INJECTION INTRAVENOUS 20100801 ANDA ANDA080205 General Injectables & Vaccines, Inc POTASSIUM CHLORIDE 2 meq/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 52584-656_878a3fdc-ea2d-4ab8-8d29-1433860bb4a0 52584-656 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20100301 ANDA ANDA070974 General Injectables & Vaccines, Inc CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 52584-665_74206cee-a676-40f1-802c-e29ed7653f46 52584-665 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate INJECTION, SOLUTION SUBCUTANEOUS 20111116 ANDA ANDA076887 General Injectables & Vaccines, Inc TERBUTALINE SULFATE 1 mg/mL 52584-695_f214ae1f-3e59-4069-8448-772ca5ad0a6b 52584-695 HUMAN PRESCRIPTION DRUG Amidate Etomidate INJECTION, SOLUTION INTRAVENOUS 20100801 NDA NDA018227 General Injectables & Vaccines, Inc ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 52584-699_f23fcee4-18be-49ad-9d4b-7bb0c68eb170 52584-699 HUMAN PRESCRIPTION DRUG Propofol Propofol INJECTION, EMULSION INTRAVENOUS 20140821 ANDA ANDA077908 General Injectables and Vaccines, Inc PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 52584-702_9fcdd6c1-08cc-4002-bee7-37393542fc31 52584-702 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 NDA NDA018579 General Injectables & Vaccines, Inc FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 52584-704_b3d04e9e-8a61-49bc-81c7-d6c65acac9fa 52584-704 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100901 NDA NDA018579 General Injectables & Vaccines, Inc FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 52584-710_19b77148-36e9-43a3-9815-081afdc50192 52584-710 HUMAN PRESCRIPTION DRUG Calcium Chloride Calcium Chloride INJECTION, SOLUTION INTRAVENOUS 20100301 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc CALCIUM CHLORIDE 100 mg/mL Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 52584-713_3fd9c5f6-15c9-40f9-83b2-bbf3099d8591 52584-713 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride Anhydrous INJECTION, SOLUTION INFILTRATION 20100901 ANDA ANDA080408 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-754_94c4bf6d-b06d-4692-b6ba-d268df7806d0 52584-754 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate Heptahydrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 ANDA ANDA075151 General Injectables & Vaccines, Inc MAGNESIUM SULFATE HEPTAHYDRATE 5 g/10mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 52584-770_3e6abddd-5eba-411c-810c-3919430bd366 52584-770 HUMAN PRESCRIPTION DRUG Torsemide Torsemide INJECTION INTRAVENOUS 20100601 ANDA ANDA090656 General Injectables and Vaccines, Inc. TORSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 52584-771_838f6e8a-6f33-4799-8532-69d1694befcc 52584-771 HUMAN PRESCRIPTION DRUG Torsemide Torsemide INJECTION INTRAVENOUS 20100601 ANDA ANDA090656 General Injectables and Vaccines, Inc. TORSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 52584-775_7fc68428-9e27-42f0-9f1f-ad258bab6ff9 52584-775 HUMAN PRESCRIPTION DRUG Infant Dextrose Dextrose INJECTION, SOLUTION INTRAVENOUS 20100701 NDA NDA019445 General Injectables & Vaccines, Inc DEXTROSE MONOHYDRATE 250 mg/mL 52584-782_f0f55c94-0c04-46c9-b82b-53efbe8ff14f 52584-782 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100301 ANDA ANDA070172 General Injectables & Vaccines, Inc NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 52584-783_ca267b11-89cd-4d77-8e58-c2478d8e258d 52584-783 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION INTRAVENOUS 20140916 ANDA ANDA078527 General Injectables and Vaccines, Inc. FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 52584-784_4225ebda-1eba-4ab8-a888-a14570e1acbd 52584-784 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION INTRAVENOUS 20140710 ANDA ANDA078527 General Injectables and Vaccines, Inc FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 52584-795_0e0d44fb-dd01-4a1f-985a-9c741bc1bb67 52584-795 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120410 ANDA ANDA074802 General Injectables & Vaccines, Inc KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52584-796_98458df1-099d-40cd-bb4f-c81295c04b67 52584-796 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120410 ANDA ANDA074802 General Injectables & Vaccines, Inc KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52584-800_4663f248-58ed-4f01-ae53-7d459bb346ab 52584-800 HUMAN PRESCRIPTION DRUG Neo-Synephrine Phenylephrine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100801 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 52584-805_295fea87-8916-48d5-bf8e-5576ea00307f 52584-805 HUMAN PRESCRIPTION DRUG Dopamine Hydrochloride Dopamine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20100701 ANDA ANDA070799 General Injectables & Vaccines, Inc DOPAMINE HYDROCHLORIDE 40 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 52584-810_d4584c30-c7b7-45b2-9b33-cc50be417a2f 52584-810 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin INJECTION, SOLUTION INTRAVENOUS 20100601 UNAPPROVED DRUG OTHER General Injectables and Vaccines, Inc. NITROGLYCERIN 5 mg/mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 52584-870_82c80111-04d1-4ff8-830e-ec43e329292e 52584-870 HUMAN PRESCRIPTION DRUG CLEOCIN PHOSPHATE clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121019 NDA NDA050441 General Injectables & Vaccines, Inc CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 52584-872_15affd7d-16db-4a64-95f0-2cbfac27093a 52584-872 HUMAN PRESCRIPTION DRUG Propranolol Propranolol INJECTION INTRAVENOUS 20110222 ANDA ANDA077760 General Injectables & Vaccines, Inc PROPRANOLOL HYDROCHLORIDE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52584-875_39cd8819-82c4-4131-a1dd-703dec5b56e7 52584-875 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION INTRAVENOUS 20140902 ANDA ANDA077234 General Injectables and Vaccines, Inc. AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 52584-881_374cdc40-0e75-4fa0-9caa-eaf62d8f4353 52584-881 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 ANDA ANDA040573 General Injectables & Vaccines, Inc PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52584-882_cdce4b55-9484-491b-9510-265c80ab356f 52584-882 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110412 ANDA ANDA040573 General Injectables & Vaccines, Inc PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52584-887_8705fbb2-5c0a-472c-b3da-4fd7386decb2 52584-887 HUMAN PRESCRIPTION DRUG Sterile Water Water SOLUTION INTRAVENOUS 20100301 NDA NDA018801 General Injectables & Vaccines, Inc WATER 10 mL/10mL 52584-888_48305494-04b1-43ed-932e-c22c02edce4b 52584-888 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20100801 NDA NDA018803 General Injectables & Vaccines, Inc SODIUM CHLORIDE 9 mg/mL 52584-900_321e2f2e-a4ee-4cd4-b694-8b44669fd828 52584-900 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION, SOLUTION INTRAVENOUS 20100801 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc SODIUM BICARBONATE 1 meq/mL 52584-901_dd7088e8-c145-4303-a76b-f53b479cebca 52584-901 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 ANDA ANDA040136 General Injectables & Vaccines, Inc HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 52584-902_17016046-66d8-4072-90fa-1c926b448807 52584-902 HUMAN PRESCRIPTION DRUG Dextrose Dextrose INJECTION, SOLUTION INTRAVENOUS 20100929 NDA NDA019445 General Injectables & Vaccines, Inc. DEXTROSE MONOHYDRATE .5 g/mL 52584-903_6132dda6-5514-42c4-94f0-04758720916b 52584-903 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20100901 ANDA ANDA083158 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-904_4697c5b9-fecb-4e1a-8150-5b9c37f1ec2f 52584-904 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine INJECTION, SOLUTION INTRAVENOUS 20100301 ANDA ANDA083158 General Injectables & Vaccine, Inc LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52584-910_9ede2e50-69cf-49c1-812b-19e4ddd0562e 52584-910 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100301 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc. ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 52584-911_f3bee61f-d36f-4d2c-b1cd-ea320e4eb876 52584-911 HUMAN PRESCRIPTION DRUG Romazicon Flumazenil INJECTION, SOLUTION INTRAVENOUS 20100901 NDA NDA020073 General Injectables & Vaccines, Inc FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 52584-912_14fda598-7eed-4f05-a71a-031e59283a5e 52584-912 HUMAN PRESCRIPTION DRUG Romazicon Flumazenil INJECTION, SOLUTION INTRAVENOUS 20100801 NDA NDA020073 General Injectables & Vaccines, Inc FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 52584-916_adfdeed7-ec8e-44d9-9b52-c46c34528044 52584-916 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION INTRAVENOUS 20110310 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc. SODIUM BICARBONATE .9 meq/mL 52584-921_b396394c-aaad-43d2-ad7f-b80deb4aa197 52584-921 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline INJECTION, SOLUTION INTRAVENOUS 20100701 ANDA ANDA087242 General Injectables & Vaccines, Inc AMINOPHYLLINE DIHYDRATE 25 mg/mL 52584-922_9251e41e-47b4-456d-8af7-0ae5f0d8bf4e 52584-922 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline INJECTION, SOLUTION INTRAVENOUS 20090101 ANDA ANDA087242 General Injectables & Vaccines, Inc. AMINOPHYLLINE DIHYDRATE 25 mg/mL 52584-928_878ab28c-0cac-456d-9fef-8ac667dff1ee 52584-928 HUMAN PRESCRIPTION DRUG Calcium Chloride Calcium Choride INJECTION, SOLUTION INTRAVENOUS 20100301 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc. CALCIUM CHLORIDE 100 mg/mL Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 52584-931_a9b7dced-3c42-4613-b660-76eda42d3465 52584-931 HUMAN PRESCRIPTION DRUG Infed Iron Dextran INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100901 NDA NDA017441 General Injectables & Vaccines, Inc IRON DEXTRAN 50 mg/mL 52584-941_b3ca8b07-152e-406f-bf8d-aa706ff4d652 52584-941 HUMAN PRESCRIPTION DRUG Talwin Pentazocine Lactate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100801 NDA NDA016194 General Injectables & Vaccines, Inc PENTAZOCINE LACTATE 30 mg/mL Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV 52584-950_c0d3d95d-f3ed-4b84-8fb1-9c37eed98c15 52584-950 HUMAN PRESCRIPTION DRUG Calcium Gluconate Calcium Gluconate INJECTION, SOLUTION INTRAVENOUS 20100401 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc. CALCIUM GLUCONATE MONOHYDRATE .465 meq/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 52584-952_994d72b4-e7f1-4038-a727-2348528e739c 52584-952 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 20100301 ANDA ANDA088804 General Injectables & Vaccines, Inc TRIMETHOBENZAMIDE HYDROCHLORIDE 100 mg/mL Antiemetic [EPC],Emesis Suppression [PE] 52584-965_10fd7c94-7e66-4681-8180-97927671dbc5 52584-965 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride INJECTION, SOLUTION INTRAVENOUS 20100801 ANDA ANDA088901 General Injectables & Vaccines, Inc POTASSIUM CHLORIDE 2 meq/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 52584-966_1cd91f80-48da-48d0-912e-3f1e5fca1f5c 52584-966 HUMAN PRESCRIPTION DRUG Bacteriastatic Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20100601 NDA NDA018800 General Injectables & Vaccines, Inc. SODIUM CHLORIDE 9 mg/mL 52584-977_dc69ffce-0c73-4a07-b527-87f08e25c712 52584-977 HUMAN PRESCRIPTION DRUG Bacteriostatic Water Water INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100801 NDA NDA018802 General Injectables & Vaccine, Inc WATER 30 mL/30mL 52584-978_2f74d869-29de-4393-9391-024f4031fc65 52584-978 HUMAN PRESCRIPTION DRUG NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTION PARENTERAL 20131206 ANDA ANDA072076 General Injectables & Vaccines, Inc NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 52599-282_8a48d46b-5165-4c2f-a262-332884337475 52599-282 HUMAN OTC DRUG Baclezene Neomycin Sulfate CREAM TOPICAL 20140619 OTC MONOGRAPH FINAL part333B Curazene, LLC NEOMYCIN SULFATE .005 g/.9g 52605-014_381cb51a-04d7-4f8c-b572-613d9cae3425 52605-014 HUMAN OTC DRUG THRULIFE EXTRA STRENGTH HEADACHE RELIEF Acetaminophen, Aspirin, Caffeine TABLET ORAL 20130131 OTC MONOGRAPH FINAL part343 Polygen Pharmaceuticals LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 52605-114_c265106e-3575-4073-8195-0aa0adb10f45 52605-114 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20120605 ANDA ANDA091239 Polygen Pharmaceuticals LLC IBUPROFEN 200 mg/1 52605-117_c265106e-3575-4073-8195-0aa0adb10f45 52605-117 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20120605 ANDA ANDA091239 Polygen Pharmaceuticals LLC IBUPROFEN 200 mg/1 52605-120_a5e2a7fd-dc7e-4f1b-9436-41b9834caaab 52605-120 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20130702 ANDA ANDA091237 Polygen Pharmaceuticals LLC IBUPROFEN 200 mg/1 52605-121_c63c2921-fc55-4ad8-a5e5-0d7258ab1f4e 52605-121 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20111128 ANDA ANDA090796 Polygen Pharmaceuticals LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52605-122_c63c2921-fc55-4ad8-a5e5-0d7258ab1f4e 52605-122 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20111128 ANDA ANDA090796 Polygen Pharmaceuticals LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52605-123_c63c2921-fc55-4ad8-a5e5-0d7258ab1f4e 52605-123 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20111128 ANDA ANDA090796 Polygen Pharmaceuticals LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52605-138_d349356e-61d3-4728-8425-1a4d513605d9 52605-138 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20120201 ANDA ANDA091416 Polygen Pharmaceuticals LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52605-139_d349356e-61d3-4728-8425-1a4d513605d9 52605-139 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20120201 ANDA ANDA091416 Polygen Pharmaceuticals LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52605-140_d349356e-61d3-4728-8425-1a4d513605d9 52605-140 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20120201 ANDA ANDA091416 Polygen Pharmaceuticals LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52605-141_b06d4755-1fbf-4fcf-9075-cb1691292aad 52605-141 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, COATED ORAL 20120611 ANDA ANDA090545 Polygen Pharmaceuticals LLC NAPROXEN SODIUM 220 mg/1 52605-144_b06d4755-1fbf-4fcf-9075-cb1691292aad 52605-144 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, COATED ORAL 20121113 ANDA ANDA090545 Polygen Pharmaceuticals LLC NAPROXEN SODIUM 220 mg/1 52609-0001_47c17893-8117-4914-9aab-49bcf02de299 52609-0001 HUMAN PRESCRIPTION DRUG ALKERAN melphalan TABLET, FILM COATED ORAL 20110101 NDA NDA014691 Apo-Pharma USA, Inc MELPHALAN 2 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 52609-0006_af4b6a41-0983-bb51-dfa2-1855923d61d4 52609-0006 HUMAN PRESCRIPTION DRUG FERRIPROX deferiprone TABLET, FILM COATED ORAL 20111125 NDA NDA021825 ApoPharma USA, Inc. DEFERIPRONE 500 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC] 52609-3001_4bfa77c3-22d7-4fa5-b840-fba8d758907b 52609-3001 HUMAN PRESCRIPTION DRUG ALKERAN melphalan hydrochloride KIT 20110101 NDA NDA020207 Apo-Pharma USA, Inc 52625-100_842f10be-4055-47b9-89f9-50e791f9f668 52625-100 HUMAN OTC DRUG Moisturizing Sunblock Titanium Dioxide LOTION TOPICAL 20100701 OTC MONOGRAPH FINAL part352 Vienna Health and Beauty Corporation BENZOPHENONE; OCTINOXATE; TITANIUM DIOXIDE 3; 6; 8 g/100g; g/100g; g/100g 52625-101_30b7ef3a-0034-45f8-978b-fb32462f3080 52625-101 HUMAN OTC DRUG Sunblock Titanium Dioxide LOTION TOPICAL 20100701 OTC MONOGRAPH FINAL part352 Vienna Health and Beauty Corporation OCTINOXATE; TITANIUM DIOXIDE 5; 6 g/80g; g/80g 52641-300_e1b7994f-93dc-4003-b71c-e60e4c54e070 52641-300 HUMAN OTC DRUG ReliaMed Zinc Oxide, Calamine DRESSING TOPICAL 20100813 OTC MONOGRAPH FINAL part347 Reliamed FERRIC OXIDE RED; ZINC OXIDE; ZINC OXIDE .015; .985; 25 g/1; g/1; g/1 52641-302_17da0d39-89b7-499f-8934-12f6464957e3 52641-302 HUMAN OTC DRUG Reliamed Zinc Oxide DRESSING TOPICAL 20100813 OTC MONOGRAPH FINAL part347 Reliamed ZINC OXIDE 25 g/1 52641-700_1d92f29c-b098-4399-8340-673f8033c3da 52641-700 HUMAN OTC DRUG Antiseptic isopropyl alcohol LIQUID TOPICAL 20110623 OTC MONOGRAPH NOT FINAL part333A ReliaMed ISOPROPYL ALCOHOL .56118 g/mL 52642-001_7a0a45ca-71f5-4fb5-9ba3-a065d4cf9ceb 52642-001 HUMAN OTC DRUG BestHealth Menthol MENTHOL LOZENGE ORAL 20121220 OTC MONOGRAPH FINAL part341 Bestco Inc. MENTHOL 5.4 mg/1 52642-002_a646fa21-aef6-4e34-8bd7-a1f576894d42 52642-002 HUMAN OTC DRUG BestHealth Cherry MENTHOL LOZENGE ORAL 20130115 OTC MONOGRAPH FINAL part341 Bestco, Inc. MENTHOL 5.8 mg/1 52642-003_55176ae9-8702-4811-8ca6-beb959c2e3ec 52642-003 HUMAN OTC DRUG BestHealth Cherry MENTHOL LOZENGE ORAL 20130115 OTC MONOGRAPH FINAL part341 Bestco, Inc. MENTHOL 7 mg/1 52642-004_7151b029-6b9f-46ff-9bb1-e46a0805e0ae 52642-004 HUMAN OTC DRUG BestHealth Honey Lemon MENTHOL LOZENGE ORAL 20130115 OTC MONOGRAPH FINAL part341 Bestco, Inc. MENTHOL 9.1 mg/1 52642-005_f0340516-800c-4dfa-b05e-dee77197dca4 52642-005 HUMAN OTC DRUG BestHealth Honey Lemon MENTHOL LOZENGE ORAL 20130115 OTC MONOGRAPH FINAL part341 Bestco, Inc. MENTHOL 7.5 mg/1 52642-006_2df8b2f8-0a74-4d5f-86dd-01fa7ea081e9 52642-006 HUMAN OTC DRUG BestHealth Cough Relief Honey Lemon Flavor DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL LOZENGE ORAL 20140217 OTC MONOGRAPH FINAL part341 Bestco, Inc. DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL 5; 5 mg/1; mg/1 52642-007_d95f5d67-4158-45ae-9cac-bec22f6b9690 52642-007 HUMAN OTC DRUG BestHealth Cough Relief Sugar Free Cherry Flavor DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL LOZENGE ORAL 20140217 OTC MONOGRAPH FINAL part341 Bestco, Inc. DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL 5; 5 mg/1; mg/1 52642-008_703ceaa3-dabd-47ea-ad5a-d03d059ce330 52642-008 HUMAN OTC DRUG BestHealth Cough Suppressant SUGAR FREE HONEY LEMON FLAVOR MENTHOL LOZENGE ORAL 20140305 OTC MONOGRAPH FINAL part341 Bestco, Inc. MENTHOL 7.6 mg/1 52642-009_62842bc9-254e-4750-b672-bd23cc147d97 52642-009 HUMAN OTC DRUG BestHealth Cough Suppressant SUGAR FREE BLACK CHERRY FLAVOR MENTHOL LOZENGE ORAL 20140305 OTC MONOGRAPH FINAL part341 Bestco, Inc. MENTHOL 5.8 mg/1 52642-010_66f8627c-44ca-4909-8493-36f00454b915 52642-010 HUMAN OTC DRUG Best Health Sore Throat Relief Cherry Flavor BENZOCAINE, MENTHOL LOZENGE ORAL 20140604 OTC MONOGRAPH NOT FINAL part356 Bestco, Inc. BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 52644-001_5acd8ebf-2b8e-40d6-a76d-7bad43ff0658 52644-001 HUMAN OTC DRUG Oral Defense Cetylpyridinium Chloride MOUTHWASH ORAL 20100726 OTC MONOGRAPH NOT FINAL part356 Oral Defense, LLC CETYLPYRIDINIUM CHLORIDE .47 mL/474mL 52644-002_bc01abf8-ac41-40c1-a4ab-1d4ba7c64a42 52644-002 HUMAN OTC DRUG Oral Defense Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20100831 OTC MONOGRAPH FINAL part355 Oral Defense, LLC SODIUM FLUORIDE .2418 g/474mL 52644-003_d9a9c8ea-b2da-4f23-ad65-23b174df6f9d 52644-003 HUMAN OTC DRUG Oral Defense Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110712 OTC MONOGRAPH FINAL part355 Oral Defense SODIUM FLUORIDE .14 g/118g 52648-6175_556865f0-7dda-46b4-9948-d987b95f740f 52648-6175 HUMAN OTC DRUG Sunscreen Wipe KGP HOMOSALATE OCTINOXATE OCTISALATE OXYBENZONE CLOTH TOPICAL 20100928 OTC MONOGRAPH FINAL part352 KGP Products, Inc. (dba PREMIER) HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 40; 50 g/856mL; g/856mL; g/856mL; g/856mL 52651-003_47917e5a-92d3-433b-a7ca-013881dc55f5 52651-003 HUMAN OTC DRUG TN Dickinsons Witch Hazel Hemorrhoidal Pads witch hazel CLOTH TOPICAL 19941201 OTC MONOGRAPH FINAL part346 Dickinson Brands Inc. WITCH HAZEL 1.2 g/1 52651-006_4af7eadc-0118-4078-bb24-7b58582432c7 52651-006 HUMAN OTC DRUG TN Dickinsons Witch Hazel Antibacterial benzethonium chloride SPRAY TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333A Dickinson Brands Inc. BENZETHONIUM CHLORIDE 2 mg/mL 52652-1001_31796137-1992-4cbc-bbd9-641d2c2c31a8 52652-1001 HUMAN PRESCRIPTION DRUG EPANED enalapril maleate KIT 20130822 NDA NDA204308 Silvergate Pharmaceuticals, Inc. 52654-0001_5be8d25b-8f2c-4ec1-8c9a-1e02ee2c33fb 52654-0001 HUMAN OTC DRUG MP Achyrocline satureioides, Arctostaphylos uva ursi leaf, Cassia occidentalis, Mirabilis jalapa, Petiveria alliacea, Physalis angulata LIQUID ORAL 20130314 UNAPPROVED HOMEOPATHIC MP ACHYROCLINE SATUREIOIDES; ARCTOSTAPHYLOS UVA-URSI LEAF; MIRABILIS JALAPA FLOWERING TOP; PETIVERIA ALLIACEA WHOLE; PHYSALIS ANGULATA; SCHINUS MOLLE BARK; SENNA OCCIDENTALIS 32; 32; 32; 32; 32; 32; 32 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52654-0002_cdb3aae1-2130-49ae-98ae-bbb80e12568a 52654-0002 HUMAN OTC DRUG DNA DNA LIQUID ORAL 20121009 UNAPPROVED HOMEOPATHIC Chi Research Inc HERRING SPERM DNA 12 [hp_X]/mL 52654-0003_7b7eae3c-0b22-4523-836a-f8c610fa416f 52654-0003 HUMAN OTC DRUG SP Spiro Complex LIQUID ORAL 20130311 UNAPPROVED HOMEOPATHIC Chi Research, Inc. BROSIMUM ACUTIFOLIUM BARK; HIMATANTHUS LANCIFOLIUS BARK; MANSOA ALLIACEA BARK; MANSOA ALLIACEA LEAF; MINQUARTIA GUIANENSIS BARK; PHYLLANTHUS NIRURI WHOLE; PIPER ADUNCUM LEAF 32; 32; 32; 32; 32; 32; 32 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52654-0004_63a27180-99d2-491f-b4b1-c6bfa34ba6ed 52654-0004 HUMAN OTC DRUG MRCL Cinnamon Essential Oil, Clove Essential Oil, Eucalyptus Essential Oil, Lemon Essential Oil, Wild Rosemary Essential Oil LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC Chi Research, Inc. CINNAMON BARK OIL; CLOVE OIL; EUCALYPTUS OIL; LEMON OIL; ROSEMARY OIL 12; 12; 12; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 52664-001_ec9df69b-cfb9-42b7-a934-d5823755720b 52664-001 HUMAN OTC DRUG ELF Super Glossy Lip Shine SPF 15 OXYBENZONE CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Hangzhou Facecare Cosmetics Co., Ltd. OCTINOXATE; OXYBENZONE 7; 5 g/100g; g/100g 52664-002_546c9d9a-c668-45c8-8d63-e0c069fda4c0 52664-002 HUMAN OTC DRUG ELF Milk and Honey Cleansing Anti-bacterial Hand TRICLOSAN LIQUID TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333A Hangzhou Facecare Cosmetics Co., Ltd. TRICLOSAN .2 g/100g 52664-003_d186b07b-df73-47af-bc67-767079051d5e 52664-003 HUMAN OTC DRUG ELF Tinted Moisturizer SPF 15 OXYBENZONE CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Hangzhou Facecare Cosmetics Co., Ltd. OCTINOXATE; OXYBENZONE 7; 5 g/100g; g/100g 52664-004_071e0740-ae99-49a4-9089-e5ed67f87c5b 52664-004 HUMAN OTC DRUG ELF Mineral Foundation SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Hangzhou Facecare Cosmetics Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; g/100g 52664-005_1a655d52-eed7-40e6-963c-4b5f6becd245 52664-005 HUMAN OTC DRUG ELF Mineral Concealers SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Hangzhou Facecare Cosmetics Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; g/100g 52664-006_8cf23594-b31f-49cf-8ccf-4c930ba32c61 52664-006 HUMAN OTC DRUG ELFMineral Blemish Kit Box SULFUR POWDER TOPICAL 20101201 OTC MONOGRAPH FINAL part333D Hangzhou Facecare Cosmetics Co., Ltd. SULFUR 3 g/100g 52664-007_22289d96-ab96-436d-9d7c-3a926d49b0e9 52664-007 HUMAN OTC DRUG ELF Zit Zapper SALICYLIC ACID LIQUID TOPICAL 20101201 OTC MONOGRAPH FINAL part358H Hangzhou Facecare Cosmetics Co., Ltd. SALICYLIC ACID 1 g/100g 52664-008_b3a6f2cd-f8c0-40c2-b798-863d9d0b1c7e 52664-008 HUMAN OTC DRUG ELF Lip Balm SPF 15 OXYBENZONE CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Hangzhou Facecare Cosmetics Co., Ltd. OCTINOXATE; OXYBENZONE 5; 4.5 g/100g; g/100g 52664-009_ef82cb7b-1847-4f0f-82c9-4a383dffb18b 52664-009 HUMAN OTC DRUG ELF Conceler Pencil and Brush SALICYLIC ACID PASTE TOPICAL 20101201 OTC MONOGRAPH FINAL part358H Hangzhou Facecare Cosmetics Co., Ltd. SALICYLIC ACID 2 g/100g 52664-010_69da62c0-818c-4787-9649-5fdb3268504f 52664-010 HUMAN OTC DRUG ELF SPF 45 Sunscreen UVA/UVB Protection TITANIUM DIOXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Hangzhou Facecare Cosmetics Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 21.25; 17 g/100g; g/100g 52667-001_91b3c023-0e22-4b14-81d1-7e0279da419e 52667-001 HUMAN OTC DRUG 100% Pure Green Tea Oil Free Moisturizer SPF 30 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part352 Purity Cosmetics TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL 52667-002_ca29aa5b-fbd0-4ad8-a61d-cd9101b1d16c 52667-002 HUMAN OTC DRUG 100% Pure Argan Oil Moisturizer SPF 30 Zinc Oxide LOTION TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part352 Purity Cosmetics ZINC OXIDE 20 mg/mL 52667-003_bc9b111f-559f-44c9-a9a4-7dc46e4a9057 52667-003 HUMAN OTC DRUG 100% Pure Baby Sunscreen SPF 30 Zinc Oxide, Titanium Dioxide STICK TOPICAL 20140909 OTC MONOGRAPH NOT FINAL part352 Purity Cosmetics TITANIUM DIOXIDE; ZINC OXIDE 80; 25 mg/g; mg/g 52667-004_8cda3ef5-4533-45b1-ab32-33865df3e5a7 52667-004 HUMAN OTC DRUG 100% Pure Everywhere Sunscreen SPF 30 Zinc Oxide, Titanium Dioxide STICK TOPICAL 20140909 OTC MONOGRAPH NOT FINAL part352 Purity Cosmetics TITANIUM DIOXIDE; ZINC OXIDE 80; 25 mg/g; mg/g 52670-550_e435568c-f8d2-4cee-aceb-c68b277ad8f5 52670-550 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 sodium fluoride F 18 INJECTION INTRAVENOUS 20130628 ANDA ANDA203605 Mayo Clinic PET Radiochemistry Facility SODIUM FLUORIDE F-18 91.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 52670-552_af70d0da-1c2d-44e4-b4cd-7cce6636c7b9 52670-552 HUMAN PRESCRIPTION DRUG Ammonia N 13 ammonia n-13 INJECTION, SOLUTION INTRAVENOUS 20130225 ANDA ANDA203321 Mayo Clinic AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 52670-556_59f2fab5-72ca-457c-8220-58a24143ac1d 52670-556 HUMAN PRESCRIPTION DRUG Choline C 11 Choline C-11 INJECTION INTRAVENOUS 20120912 NDA NDA203155 Mayo Clinic CHOLINE C-11 33.1 mCi/mL 52674-544_44fd7baa-baea-45c7-b1ab-7cb198762b7d 52674-544 HUMAN OTC DRUG Gold and Sudsy CHLOROXYLENOL SOAP TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333E Cosgrove Enterprises, Inc. CHLOROXYLENOL .003 mg/mL 52675-030_ceaec008-c59e-42c3-bedb-69cc38b43a95 52675-030 HUMAN OTC DRUG SunScreen Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20120514 OTC MONOGRAPH NOT FINAL part352 Crown Products, LLC OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 2; 4; 2.5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 52682-022_ee6600e6-1335-4d93-96b5-4c7effc9ddb1 52682-022 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20110822 ANDA ANDA040823 Mirror Pharmaceuticals LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 52682-023_dd9f5153-0307-46cc-8e66-1ac5003431a4 52682-023 HUMAN PRESCRIPTION DRUG Carisoprodol and Aspirin Carisoprodol and Aspirin TABLET ORAL 20110609 ANDA ANDA040832 Mirror Pharmaceuticals LLC ASPIRIN; CARISOPRODOL 325; 200 mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIV 52682-024_f76429ae-aa96-4a7a-8ae2-b031eb484d5c 52682-024 HUMAN PRESCRIPTION DRUG Carisoprodol, Aspirin and Codeine Phosphate Carisoprodol, Aspirin and Codeine Phosphate TABLET ORAL 20110626 ANDA ANDA040832 Mirror Pharmaceuticals LLC ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE 325; 200; 16 mg/1; mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Full Opioid Agonists [MoA],Opioid Agonist [EPC],Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIII 52682-026_ab907b70-5cdc-49b4-a702-1b14e1351a96 52682-026 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20110808 ANDA ANDA040883 Mirror Pharmaceuticals LLC ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 52682-041_c8e51a2a-17c9-473a-aff1-dd776006c0a9 52682-041 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20110808 ANDA ANDA040864 Mirror Pharmaceuticals LLC ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 52682-047_3d8b18a9-7a82-4b6f-8725-a2249dfe871e 52682-047 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20111101 ANDA ANDA091451 Mirror Pharmaceuticals LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 52682-206_3cb67478-1a51-4e7d-a529-79029655f5d9 52682-206 HUMAN OTC DRUG SODIUM BICARBONATE SODIUM BICARBONATE TABLET ORAL 20110124 OTC MONOGRAPH FINAL part331 Mirror Pharmaceuticals LLC SODIUM BICARBONATE 650 mg/1 52684-0025_36737b3b-9074-4cf7-8bad-7ecbd5c42eff 52684-0025 HUMAN OTC DRUG BioPhenolics Acetylcholine chloride, Acetaldehyde, Apiolum, Ascorbic acid, BHT, Caffeic acid, Candida albicans, Chlorogenic acid, Cinnamic acid, Coniferyl Alcohol, Coumarin, Dopamine, Estrogen, GABA, Gallic acid, Histamine, Indole, L-Dopa, Malvin, Mannan, Melatonin, Menadione, Norepinephrine, Octopamine, Phenylalanine, Phenyli-sothiocyanate, Phlorizin, Piperine, Progesterone, Pyrrole, Quercetin, Rutin, Salsolinol, Serotonin, Taurine, Testosterone, Tryptophan SPRAY ORAL 20120517 UNAPPROVED HOMEOPATHIC BioVeda .GAMMA.-AMINOBUTYRIC ACID; ACETALDEHYDE; ACETYLCHOLINE CHLORIDE; APIOLE (PARSLEY); ASCORBIC ACID; BUTYLATED HYDROXYTOLUENE; CAFFEIC ACID; CANDIDA ALBICANS; CINNAMIC ACID; CONIFERYL ALCOHOL; COUMARIN; DOPAMINE; ESTRONE; GALLIC ACID; HISTAMINE; INDOLE; LEVODOPA; MALVIN; MELATONIN; MENADIONE; NOREPINEPHRINE; OCTOPAMINE; PHENYL ISOTHIOCYANATE; PHENYLALANINE; PHLORIZIN; PIPERINE; PROGESTERONE; PYRROLE; QUERCETIN; QUINIC ACID; RUTIN; SALSOLINOL; SEROTONIN; TAURINE; TESTOSTERONE; TRYPTOPHAN; YEAST MANNAN 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 52684-0026_062d35eb-716d-426a-95d2-3fdf520af584 52684-0026 HUMAN OTC DRUG BioTerrain Plus Anagallis arvensis, Aqua marina, Fucus vesiculosus, Mentha piperita, Rosa damascene, Silica marina, Cuprum metallicum, Ferrum phosphoricum, Fumaricum acidum, Aralia hispida, Chimaphila maculate, Derris pinnata, Hedeoma pulegioides, Ononis spinosa, Physalis alkekengi, Quassia amara, Saccharum officinale, Hydrofluoricum acidum SPRAY ORAL 20120603 UNAPPROVED HOMEOPATHIC BioVeda ANAGALLIS ARVENSIS; ARALIA HISPIDA ROOT; CHIMAPHILA MACULATA; COPPER; DALBERGIA PINNATA ROOT; FERROSOFERRIC PHOSPHATE; FUCUS VESICULOSUS; HEDEOMA PULEGIOIDES; HYDROFLUORIC ACID; MENTHA PIPERITA; ONONIS CAMPESTRIS; QUASSIA AMARA WOOD; ROSA DAMASCENA FLOWERING TOP; SILICON DIOXIDE; SUCROSE; WATER 3; 144; 144; 144; 144; 144; 3; 1; 144; 3; 144; 144; 3; 3; 144; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 52685-191_dc6982b3-31a5-4423-9d95-947ce6e1992a 52685-191 HUMAN OTC DRUG CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES Octinoxate and Titanium dioxide CREAM TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 1160; 2320 mg/40g; mg/40g 52685-192_df8c3e06-06df-4abe-8111-bcfd93e6f805 52685-192 HUMAN OTC DRUG CLE DE PEAU BEAUTE SMOOTHING BASE FOR LINES Titanium dioxide CREAM TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 3960 mg/40g 52685-300_9720078d-ca93-43ca-bcef-a528bced3ea4 52685-300 HUMAN OTC DRUG CLE DE PEAU BEAUTE BF20 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 1.65 mg/11g; g/11g 52685-301_9720078d-ca93-43ca-bcef-a528bced3ea4 52685-301 HUMAN OTC DRUG CLE DE PEAU BEAUTE I10 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 1.65 mg/11g; g/11g 52685-302_9720078d-ca93-43ca-bcef-a528bced3ea4 52685-302 HUMAN OTC DRUG CLE DE PEAU BEAUTE O10 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 1.65 mg/11g; g/11g 52685-303_9720078d-ca93-43ca-bcef-a528bced3ea4 52685-303 HUMAN OTC DRUG CLE DE PEAU BEAUTE O20 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 1.65 mg/11g; g/11g 52685-304_9720078d-ca93-43ca-bcef-a528bced3ea4 52685-304 HUMAN OTC DRUG CLE DE PEAU BEAUTE O30 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 1.65 mg/11g; g/11g 52685-305_9720078d-ca93-43ca-bcef-a528bced3ea4 52685-305 HUMAN OTC DRUG CLE DE PEAU BEAUTE B10 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 1.65 mg/11g; g/11g 52685-306_9720078d-ca93-43ca-bcef-a528bced3ea4 52685-306 HUMAN OTC DRUG CLE DE PEAU BEAUTE B20 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 1.65 mg/11g; g/11g 52685-307_9720078d-ca93-43ca-bcef-a528bced3ea4 52685-307 HUMAN OTC DRUG CLE DE PEAU BEAUTE B30 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 1.65 mg/11g; g/11g 52685-308_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-308 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) I00 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g 52685-309_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-309 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) I20 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g 52685-310_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-310 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) I40 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g 52685-311_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-311 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) I60 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g 52685-312_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-312 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) B20 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g 52685-313_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-313 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) B40 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g 52685-314_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-314 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) B60 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g 52685-315_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-315 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) O20 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g 52685-316_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-316 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) O40 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g 52685-317_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-317 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) O60 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g 52685-318_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-318 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) O80 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g 52685-319_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-319 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I00 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g 52685-320_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-320 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I20 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g 52685-321_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-321 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I40 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g 52685-322_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-322 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I60 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g 52685-323_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-323 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) B20 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g 52685-324_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-324 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) B40 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g 52685-325_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-325 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) B60 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g 52685-326_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-326 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O20 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g 52685-327_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-327 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O40 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g 52685-328_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-328 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O60 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g 52685-329_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-329 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O80 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g 52685-330_a3c38c20-b6a6-4aa0-b2f4-fa622a660703 52685-330 HUMAN OTC DRUG CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION BF20 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.896 g/12g 52685-331_a3c38c20-b6a6-4aa0-b2f4-fa622a660703 52685-331 HUMAN OTC DRUG CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION I10 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.896 g/12g 52685-332_a3c38c20-b6a6-4aa0-b2f4-fa622a660703 52685-332 HUMAN OTC DRUG CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION O10 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.896 g/12g 52685-333_a3c38c20-b6a6-4aa0-b2f4-fa622a660703 52685-333 HUMAN OTC DRUG CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION O20 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.896 g/12g 52685-334_a3c38c20-b6a6-4aa0-b2f4-fa622a660703 52685-334 HUMAN OTC DRUG CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION O30 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.896 g/12g 52685-335_a3c38c20-b6a6-4aa0-b2f4-fa622a660703 52685-335 HUMAN OTC DRUG CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION B10 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.896 g/12g 52685-336_a3c38c20-b6a6-4aa0-b2f4-fa622a660703 52685-336 HUMAN OTC DRUG CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION B20 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.896 g/12g 52685-337_a3c38c20-b6a6-4aa0-b2f4-fa622a660703 52685-337 HUMAN OTC DRUG CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION B30 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.896 g/12g 52685-338_b0add565-b40b-43c3-8606-19c34c1c8049 52685-338 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION I BF20 Titanium dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .65625 g/31.25g 52685-339_b0add565-b40b-43c3-8606-19c34c1c8049 52685-339 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION I I10 Titanium dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .65625 g/31.25g 52685-340_b0add565-b40b-43c3-8606-19c34c1c8049 52685-340 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION I O10 Titanium dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .65625 g/31.25g 52685-341_b0add565-b40b-43c3-8606-19c34c1c8049 52685-341 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION I O20 Titanium dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .65625 g/31.25g 52685-342_b0add565-b40b-43c3-8606-19c34c1c8049 52685-342 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION I O30 Titanium dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .65625 g/31.25g 52685-343_b0add565-b40b-43c3-8606-19c34c1c8049 52685-343 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION I B10 Titanium dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .65625 g/31.25g 52685-344_b0add565-b40b-43c3-8606-19c34c1c8049 52685-344 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION I B20 Titanium dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .65625 g/31.25g 52685-345_b0add565-b40b-43c3-8606-19c34c1c8049 52685-345 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION I B30 Titanium dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .65625 g/31.25g 52685-346_e375fa1f-32b9-4404-88d6-64d4be68ccb5 52685-346 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFRESHING PROTECTIVE I Ensulizole, Octinoxate, Octocrylene, and Oxybenzone CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 1.90875; 6.23525; 3.8175; 1.2725 g/127.25g; g/127.25g; g/127.25g; g/127.25g 52685-347_d49f5e40-ff3b-441a-9f4d-f949ce22c9f9 52685-347 HUMAN OTC DRUG CLE DE PEAU BEAUTE GENTLE PROTECTIVE I Ensulizole, Octinoxate, Octocrylene, and Oxybenzone CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 1.92; 6.272; 3.84; 1.28 g/128g; g/128g; g/128g; g/128g 52685-348_4310b8bf-0e95-46d5-82e7-8a7778b1f36b 52685-348 HUMAN OTC DRUG SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL) B00 Octinoxate and Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-349_4310b8bf-0e95-46d5-82e7-8a7778b1f36b 52685-349 HUMAN OTC DRUG SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL) B100 Octinoxate and Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-350_4310b8bf-0e95-46d5-82e7-8a7778b1f36b 52685-350 HUMAN OTC DRUG SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL) I00 Octinoxate and Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-351_4310b8bf-0e95-46d5-82e7-8a7778b1f36b 52685-351 HUMAN OTC DRUG SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL) O00 Octinoxate and Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-352_8ee4c4ae-431b-4212-ab85-210401a896e5 52685-352 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B00 Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-353_8ee4c4ae-431b-4212-ab85-210401a896e5 52685-353 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B100 Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-354_8ee4c4ae-431b-4212-ab85-210401a896e5 52685-354 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I100 Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-356_169db7f3-d203-40a7-a515-0bc2cc6dfb73 52685-356 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I BF20 Octinoxate and Titanium dioxide CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .53865; 1.16235 g/28.35g; g/28.35g 52685-357_169db7f3-d203-40a7-a515-0bc2cc6dfb73 52685-357 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I I10 Octinoxate and Titanium dioxide CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .53865; 1.16235 g/28.35g; g/28.35g 52685-358_169db7f3-d203-40a7-a515-0bc2cc6dfb73 52685-358 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I O10 Octinoxate and Titanium dioxide CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .53865; 1.16235 g/28.35g; g/28.35g 52685-359_169db7f3-d203-40a7-a515-0bc2cc6dfb73 52685-359 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I O20 Octinoxate and Titanium dioxide CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .53865; 1.16235 g/28.35g; g/28.35g 52685-360_169db7f3-d203-40a7-a515-0bc2cc6dfb73 52685-360 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I O30 Octinoxate and Titanium dioxide CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .53865; 1.16235 g/28.35g; g/28.35g 52685-361_169db7f3-d203-40a7-a515-0bc2cc6dfb73 52685-361 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I B10 Octinoxate and Titanium dioxide CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .53865; 1.16235 g/28.35g; g/28.35g 52685-362_169db7f3-d203-40a7-a515-0bc2cc6dfb73 52685-362 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I B20 Octinoxate and Titanium dioxide CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .53865; 1.16235 g/28.35g; g/28.35g 52685-363_169db7f3-d203-40a7-a515-0bc2cc6dfb73 52685-363 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I B30 Octinoxate and Titanium dioxide CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .53865; 1.16235 g/28.35g; g/28.35g 52685-364_577bf1ee-61af-4b07-bd5b-7db2396e35f0 52685-364 HUMAN OTC DRUG CLE DE PEAU BEAUTE PW FOUNDATION s BF20 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 363 mg/11g; mg/11g 52685-365_577bf1ee-61af-4b07-bd5b-7db2396e35f0 52685-365 HUMAN OTC DRUG CLE DE PEAU BEAUTE PW FOUNDATION s I10 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 363 mg/11g; mg/11g 52685-366_577bf1ee-61af-4b07-bd5b-7db2396e35f0 52685-366 HUMAN OTC DRUG CLE DE PEAU BEAUTE PW FOUNDATION s O10 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 363 mg/11g; mg/11g 52685-367_577bf1ee-61af-4b07-bd5b-7db2396e35f0 52685-367 HUMAN OTC DRUG CLE DE PEAU BEAUTE PW FOUNDATION s O20 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 363 mg/11g; mg/11g 52685-368_577bf1ee-61af-4b07-bd5b-7db2396e35f0 52685-368 HUMAN OTC DRUG CLE DE PEAU BEAUTE PW FOUNDATION s O30 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 363 mg/11g; mg/11g 52685-369_577bf1ee-61af-4b07-bd5b-7db2396e35f0 52685-369 HUMAN OTC DRUG CLE DE PEAU BEAUTE PW FOUNDATION s B10 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 363 mg/11g; mg/11g 52685-370_577bf1ee-61af-4b07-bd5b-7db2396e35f0 52685-370 HUMAN OTC DRUG CLE DE PEAU BEAUTE PW FOUNDATION s B20 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 363 mg/11g; mg/11g 52685-371_577bf1ee-61af-4b07-bd5b-7db2396e35f0 52685-371 HUMAN OTC DRUG CLE DE PEAU BEAUTE PW FOUNDATION s B30 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 363 mg/11g; mg/11g 52685-372_ba7cd809-905c-4b89-bd08-4e61433ecee4 52685-372 HUMAN OTC DRUG CLE DE PEAU BEAUTE CR COMPACT FOUNDATION BF20 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 684 mg/12g 52685-373_ba7cd809-905c-4b89-bd08-4e61433ecee4 52685-373 HUMAN OTC DRUG CLE DE PEAU BEAUTE CR COMPACT FOUNDATION I10 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 684 mg/12g 52685-374_ba7cd809-905c-4b89-bd08-4e61433ecee4 52685-374 HUMAN OTC DRUG CLE DE PEAU BEAUTE CR COMPACT FOUNDATION O10 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 684 mg/12g 52685-375_ba7cd809-905c-4b89-bd08-4e61433ecee4 52685-375 HUMAN OTC DRUG CLE DE PEAU BEAUTE CR COMPACT FOUNDATION O20 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 684 mg/12g 52685-376_ba7cd809-905c-4b89-bd08-4e61433ecee4 52685-376 HUMAN OTC DRUG CLE DE PEAU BEAUTE CR COMPACT FOUNDATION O30 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 684 mg/12g 52685-377_ba7cd809-905c-4b89-bd08-4e61433ecee4 52685-377 HUMAN OTC DRUG CLE DE PEAU BEAUTE CR COMPACT FOUNDATION B10 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 684 mg/12g 52685-378_ba7cd809-905c-4b89-bd08-4e61433ecee4 52685-378 HUMAN OTC DRUG CLE DE PEAU BEAUTE CR COMPACT FOUNDATION B20 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 684 mg/12g 52685-379_ba7cd809-905c-4b89-bd08-4e61433ecee4 52685-379 HUMAN OTC DRUG CLE DE PEAU BEAUTE CR COMPACT FOUNDATION B30 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 684 mg/12g 52685-380_acc7e724-215c-49b5-b751-511ae370ab44 52685-380 HUMAN OTC DRUG CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER Ensulizole and Octinoxate CREAM TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. ENSULIZOLE; OCTINOXATE 430; 1054 mg/21.52g; mg/21.52g 52685-381_a564f100-f982-4a8f-a0d0-e9129fe5c872 52685-381 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION BF20 Octinoxate EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g 52685-382_a564f100-f982-4a8f-a0d0-e9129fe5c872 52685-382 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION I10 Octinoxate EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g 52685-383_a564f100-f982-4a8f-a0d0-e9129fe5c872 52685-383 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O10 Octinoxate EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g 52685-384_a564f100-f982-4a8f-a0d0-e9129fe5c872 52685-384 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O20 Octinoxate EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g 52685-385_a564f100-f982-4a8f-a0d0-e9129fe5c872 52685-385 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O30 Octinoxate EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g 52685-386_a564f100-f982-4a8f-a0d0-e9129fe5c872 52685-386 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION B10 Octinoxate EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g 52685-387_a564f100-f982-4a8f-a0d0-e9129fe5c872 52685-387 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION B20 Octinoxate EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g 52685-388_a564f100-f982-4a8f-a0d0-e9129fe5c872 52685-388 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION B30 Octinoxate EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g 52685-391_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-391 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O00 Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-392_8ee4c4ae-431b-4212-ab85-210401a896e5 52685-392 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) WB40 Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-393_8ee4c4ae-431b-4212-ab85-210401a896e5 52685-393 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) WB60 Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-394_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-394 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I00 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-395_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-395 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I20 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-396_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-396 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I40 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-397_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-397 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I60 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-398_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-398 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) B20 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-399_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-399 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) B40 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-400_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-400 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) B60 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-401_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-401 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O20 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-402_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-402 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O40 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-403_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-403 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O60 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-404_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-404 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O80 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-405_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-405 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) B00 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-406_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-406 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) B100 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-407_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-407 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I100 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-408_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-408 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O00 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-409_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-409 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) WB40 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-410_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-410 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) WB60 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-422_663ef438-339a-48f0-a798-97c2b62ff7de 52685-422 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION I00 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g 52685-423_663ef438-339a-48f0-a798-97c2b62ff7de 52685-423 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION I20 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g 52685-424_663ef438-339a-48f0-a798-97c2b62ff7de 52685-424 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION I40 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g 52685-425_663ef438-339a-48f0-a798-97c2b62ff7de 52685-425 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION I60 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g 52685-426_663ef438-339a-48f0-a798-97c2b62ff7de 52685-426 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION B20 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g 52685-427_663ef438-339a-48f0-a798-97c2b62ff7de 52685-427 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION B40 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g 52685-428_663ef438-339a-48f0-a798-97c2b62ff7de 52685-428 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION B60 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g 52685-429_663ef438-339a-48f0-a798-97c2b62ff7de 52685-429 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION O20 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g 52685-430_663ef438-339a-48f0-a798-97c2b62ff7de 52685-430 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION O40 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g 52685-431_663ef438-339a-48f0-a798-97c2b62ff7de 52685-431 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION O60 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g 52685-432_c328c80b-e64f-4a8a-b2bf-3ec88136a1f2 52685-432 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION Control Color TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 250 mg/10g 52685-433_c81517c8-8d43-4553-a8d3-d14001628773 52685-433 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) I00 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g 52685-434_c81517c8-8d43-4553-a8d3-d14001628773 52685-434 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) I20 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g 52685-435_c81517c8-8d43-4553-a8d3-d14001628773 52685-435 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) I40 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g 52685-436_c81517c8-8d43-4553-a8d3-d14001628773 52685-436 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) I60 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g 52685-437_c81517c8-8d43-4553-a8d3-d14001628773 52685-437 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) B20 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g 52685-438_c81517c8-8d43-4553-a8d3-d14001628773 52685-438 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) B40 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g 52685-439_c81517c8-8d43-4553-a8d3-d14001628773 52685-439 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) B60 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g 52685-440_c81517c8-8d43-4553-a8d3-d14001628773 52685-440 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) O20 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g 52685-441_c81517c8-8d43-4553-a8d3-d14001628773 52685-441 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) O40 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g 52685-442_c81517c8-8d43-4553-a8d3-d14001628773 52685-442 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) O60 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g 52685-443_c81517c8-8d43-4553-a8d3-d14001628773 52685-443 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) O80 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g 52685-444_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-444 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I00 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-445_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-445 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I20 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-446_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-446 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I40 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-447_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-447 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I60 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-448_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-448 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B20 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-449_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-449 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B40 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-450_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-450 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B60 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-451_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-451 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O20 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-452_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-452 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O40 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-453_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-453 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O60 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-454_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-454 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O80 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g 52685-455_55ac9cc2-74dc-4c0b-8a5a-7f8743063b1a 52685-455 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) D10 Octinoxate and Titanium dioxide POWDER TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-456_55ac9cc2-74dc-4c0b-8a5a-7f8743063b1a 52685-456 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) D20 Octinoxate and Titanium dioxide POWDER TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-457_55ac9cc2-74dc-4c0b-8a5a-7f8743063b1a 52685-457 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) D30 Octinoxate and Titanium dioxide POWDER TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g 52685-458_57007676-ec08-4599-9d6c-7d03a685b982 52685-458 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) D10 Titanium dioxide POWDER TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 864 mg/12g 52685-459_57007676-ec08-4599-9d6c-7d03a685b982 52685-459 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) D20 Titanium dioxide POWDER TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 864 mg/12g 52685-460_57007676-ec08-4599-9d6c-7d03a685b982 52685-460 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) D30 Titanium dioxide POWDER TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 864 mg/12g 52685-461_ab52a7bc-9b1b-4103-9f94-57e5370c5236 52685-461 HUMAN OTC DRUG CLE DE PEAU BEAUTE GENTLE PROTECTIVE I AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE EMULSION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3163; 9361; 2530; 1265 mg/126.5g; mg/126.5g; mg/126.5g; mg/126.5g 52685-462_cd8f9cae-a9a6-41cf-9d9d-38c5d4d7c989 52685-462 HUMAN OTC DRUG CLE DE PEAU BEAUTE GENTLE PROTECTIVE I AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE EMULSION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3163; 9361; 2530; 1265 mg/126.5g; mg/126.5g; mg/126.5g; mg/126.5g 52685-463_2a5ab304-f70b-43a9-bce0-668f1d391170 52685-463 HUMAN OTC DRUG CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 523; 1548; 418 mg/20.92g; mg/20.92g; mg/20.92g 52685-464_49e2c3a2-610b-4043-a686-7cb497238126 52685-464 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O40 OCTINOXATE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g 52685-465_49e2c3a2-610b-4043-a686-7cb497238126 52685-465 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O50 OCTINOXATE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g 52685-466_49e2c3a2-610b-4043-a686-7cb497238126 52685-466 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O60 OCTINOXATE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g 52686-106_d73e6a8d-018b-404c-b626-97738c62cec8 52686-106 HUMAN OTC DRUG BENEFIANCE PROTECTIVE HAND REVITALIZER OCTINOXATE CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE 5550 mg/75g 52686-134_591e99ff-6d8d-4489-bded-c68b1c930701 52686-134 HUMAN OTC DRUG SHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER OCTINOXATE LIPSTICK TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE 196 mg/4g 52686-221_cfb1b58a-f158-4159-8659-c6cd46bf9560 52686-221 HUMAN OTC DRUG SHISEIDO Future LX Day/Jour Ensulizole, Octinoxate and Octocrylene CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; OCTOCRYLENE 1.02; 2.5; 2.55 g/51g; g/51g; g/51g 52686-222_690625fb-6bfe-4c45-8ab6-fa051ed38acd 52686-222 HUMAN OTC DRUG SHISEIDO SUNCARE EXTRA SMOOTH Octinoxate and Zinc Oxide CREAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; ZINC OXIDE 4.2; 5.5 g/57g; g/57g 52686-223_78b208ea-da61-4034-9f32-233d61dffc48 52686-223 HUMAN OTC DRUG SHISEIDO SUNCARE EXTRA SMOOTH Octinoxate and Zinc Oxide LOTION TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; ZINC OXIDE 6.956; 9.024 g/94g; g/94g 52686-224_7ec6b666-12c3-46de-81b2-c51d0200d457 52686-224 HUMAN OTC DRUG SHISEIDO SUNCARE ULTIMATE Octinoxate, Titanium Dioxide, and Zinc Oxide CREAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.516; .748; 5.542 g/34g; g/34g; g/34g 52686-225_d175a9f5-78aa-4e06-8db7-39960edb3075 52686-225 HUMAN OTC DRUG SHISEIDO SUNCARE ULTIMATE Octinoxate, Titanium Dioxide, and Zinc Oxide CREAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4.218; 1.254; 9.291 g/57g; g/57g; g/57g 52686-226_579fc74a-8993-4b78-bf64-78efdb85dcf0 52686-226 HUMAN OTC DRUG SHISEIDO SUNCARE ULTIMATE Ensulizole, Octinoxate, and Zinc Oxide LOTION TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; ZINC OXIDE 1.88; 6.956; 15.322 g/94g; g/94g; g/94g 52686-227_1e4b266f-4f72-494f-a186-fa748cd1ea91 52686-227 HUMAN OTC DRUG SHISEIDO WHITE LUCENT Ensulizole, Octinoxate, and Titanium Dioxide CREAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 1.275; 3.774; .969 g/51g; g/51g; g/51g 52686-228_c7a40719-a7da-4fe4-b638-a6104d05bd25 52686-228 HUMAN OTC DRUG SHISEIDO WHITE LUCENT Octinoxate and Octocrylene EMULSION TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE 3.479; 3.55 g/71g; g/71g 52686-229_9ba056c5-67bc-4929-a7a0-6a118b371934 52686-229 HUMAN OTC DRUG SHISEIDO MAKEUP REFINING MAKEUP PRIMER Octinoxate and Titanium dioxide CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1.528016; 2.3388 g/31.184g; g/31.184g 52686-230_2ff82d9f-eb5a-4de2-93ea-9de6d47936c3 52686-230 HUMAN OTC DRUG SHISEIDO BENEFIANCE WRINKLERESIST24 DAY Octinoxate and Octocrylene CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE 2.51125; 2.5625 g/51.25g; g/51.25g 52686-231_ef81e918-4913-4f9d-b3cc-e286867f301b 52686-231 HUMAN OTC DRUG SHISEIDO BENEFIANCE WRINKLERESIST24 DAY Octinoxate and Octocrylene EMULSION TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE 3.81465; 3.8925 g/77.85g; g/77.85g 52686-232_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-232 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION I00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g 52686-233_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-233 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION I20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g 52686-234_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-234 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION I40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g 52686-235_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-235 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION I60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g 52686-236_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-236 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION I100 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g 52686-237_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-237 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION B00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g 52686-238_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-238 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION B20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g 52686-239_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-239 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION B40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g 52686-240_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-240 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION B60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g 52686-241_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-241 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION B100 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g 52686-242_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-242 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION O00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g 52686-243_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-243 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION O20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g 52686-244_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-244 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION O40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g 52686-245_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-245 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION O60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g 52686-246_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-246 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION O80 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g 52686-249_f8382ceb-2d81-4391-a305-f1d882ff8481 52686-249 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL BASE UV IVORY OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .9396; 2.7216 g/32.4g; g/32.4g 52686-250_f8382ceb-2d81-4391-a305-f1d882ff8481 52686-250 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL BASE UV GREEN OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .9396; 2.7216 g/32.4g; g/32.4g 52686-251_f8382ceb-2d81-4391-a305-f1d882ff8481 52686-251 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL BASE UV PINK OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .9396; 2.7216 g/32.4g; g/32.4g 52686-252_e0089017-8514-4659-afd8-a4a964a2bf6c 52686-252 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) O00 OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .39; .66 g/10g; g/10g 52686-253_e0089017-8514-4659-afd8-a4a964a2bf6c 52686-253 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) O20 OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .39; .66 g/10g; g/10g 52686-254_e0089017-8514-4659-afd8-a4a964a2bf6c 52686-254 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) O40 OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .39; .66 g/10g; g/10g 52686-255_e0089017-8514-4659-afd8-a4a964a2bf6c 52686-255 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) O60 OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .39; .66 g/10g; g/10g 52686-256_e0089017-8514-4659-afd8-a4a964a2bf6c 52686-256 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) BF20 OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .39; .66 g/10g; g/10g 52686-257_e0089017-8514-4659-afd8-a4a964a2bf6c 52686-257 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) I00 OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .39; .66 g/10g; g/10g 52686-258_b0a71b44-8e42-4ef1-b343-89ee66e70302 52686-258 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR Octinoxate, Octocrylene, and Zinc Oxide EMULSION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 2.27; .92; 2.64 g/30.66g; g/30.66g; g/30.66g 52686-259_177f1296-f84a-40f1-9b0a-77d3f5f70649 52686-259 HUMAN OTC DRUG CLE DE PEAU BEAUTE UV PROTECTION Octinoxate, Octocrylene, Oxybenzone, and Zinc oxide CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 4.06; 1.65; .82; 4.94 g/54.91g; g/54.91g; g/54.91g; g/54.91g 52686-260_46686efd-64b6-42a9-a329-ddedd0141ce5 52686-260 HUMAN OTC DRUG SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 1 LIGHT Octinoxate and Titanium Dioxide CREAM TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1149; 7556 mg/60.45g; mg/60.45g 52686-261_46686efd-64b6-42a9-a329-ddedd0141ce5 52686-261 HUMAN OTC DRUG SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 2 MEDIUM Octinoxate and Titanium Dioxide CREAM TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1149; 7556 mg/60.45g; mg/60.45g 52686-262_46686efd-64b6-42a9-a329-ddedd0141ce5 52686-262 HUMAN OTC DRUG SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 3 MEDIUM DEEP Octinoxate and Titanium Dioxide CREAM TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1149; 7556 mg/60.45g; mg/60.45g 52686-263_46686efd-64b6-42a9-a329-ddedd0141ce5 52686-263 HUMAN OTC DRUG SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 4 DEEP Octinoxate and Titanium Dioxide CREAM TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1149; 7556 mg/60.45g; mg/60.45g 52686-264_4bbb3c07-5fb8-4257-a17a-f52689ae3b2f 52686-264 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION SP10 TITANIUM DIOXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. TITANIUM DIOXIDE 1488 mg/36.3g 52686-265_4bbb3c07-5fb8-4257-a17a-f52689ae3b2f 52686-265 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION SP20 TITANIUM DIOXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. TITANIUM DIOXIDE 1488 mg/36.3g 52686-266_4bbb3c07-5fb8-4257-a17a-f52689ae3b2f 52686-266 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION SP30 TITANIUM DIOXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. TITANIUM DIOXIDE 1488 mg/36.3g 52686-267_4bbb3c07-5fb8-4257-a17a-f52689ae3b2f 52686-267 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION SP40 TITANIUM DIOXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. TITANIUM DIOXIDE 1488 mg/36.3g 52686-268_4bbb3c07-5fb8-4257-a17a-f52689ae3b2f 52686-268 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION SP50 TITANIUM DIOXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. TITANIUM DIOXIDE 1488 mg/36.3g 52686-269_4bbb3c07-5fb8-4257-a17a-f52689ae3b2f 52686-269 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION SP60 TITANIUM DIOXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. TITANIUM DIOXIDE 1488 mg/36.3g 52686-270_4bbb3c07-5fb8-4257-a17a-f52689ae3b2f 52686-270 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION SP70 TITANIUM DIOXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. TITANIUM DIOXIDE 1488 mg/36.3g 52686-271_da8aac41-04d7-49c0-8440-ebc4ce944f50 52686-271 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT UV PROTECTION OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 1583; 1638; 5788 mg/54.6g; mg/54.6g; mg/54.6g 52686-272_89dd0490-cade-4a7a-8e51-6c06a3be8df3 52686-272 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 1557; 953; 3971 mg/31.77g; mg/31.77g; mg/31.77g 52686-273_7a2b9caa-0474-4ea6-8030-041a3a06cc60 52686-273 HUMAN OTC DRUG SHISEIDO ULTIMATE SUN PROTECTION PLUS OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 4503; 1826; 1034; 11.74 g/60.85g; g/60.85g; mg/60.85g; g/60.85g 52686-274_0942ab93-e0f4-43a9-a395-87b72da6e95b 52686-274 HUMAN OTC DRUG SHISEIDO ULTIMATE SUN PROTECTION PLUS OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 8673; 3516; 1992; 22.62 mg/100mL; mg/100mL; mg/100mL; g/100mL 52686-275_5719a5e5-71d4-4300-9d59-f9c0e7ee655c 52686-275 HUMAN OTC DRUG CLE DE PEAU BEAUTE UV PROTECTION OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 4348; 1763; 9635 mg/58.75g; mg/58.75g; mg/58.75g 52686-276_e166930e-098e-43a0-8835-59a1844bf9ec 52686-276 HUMAN OTC DRUG SHISEIDO REFINING MAKEUP PRIMER OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1661; 2509 mg/33.9g; mg/33.9g 52686-277_4443bb6a-acb3-49f8-9059-b1ba524ab13b 52686-277 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION D10 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 983; 1966 mg/33.9g; mg/33.9g 52686-278_4443bb6a-acb3-49f8-9059-b1ba524ab13b 52686-278 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION D20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 983; 1966 mg/33.9g; mg/33.9g 52686-279_4443bb6a-acb3-49f8-9059-b1ba524ab13b 52686-279 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION D30 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 983; 1966 mg/33.9g; mg/33.9g 52686-280_87d5cf03-f5a3-4cb1-b183-4a2e63814f96 52686-280 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING PROTECTIVE W AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1284; 3800; 1027 mg/51.35g; mg/51.35g; mg/51.35g 52686-281_6e368a8b-9d46-447c-9c35-97a53c30e842 52686-281 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING PROTECTIVE W AVOBENZONE, OCTINOXATE, and OCTOCRYLENE EMULSION TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1915; 5667; 1532 mg/76.58g; mg/76.58g; mg/76.58g 52686-282_06afa6db-cbeb-4640-882c-9e3c9a7d079b 52686-282 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION BEIGE OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 261; 414 mg/9g; mg/9g 52686-283_06afa6db-cbeb-4640-882c-9e3c9a7d079b 52686-283 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION OCHRE OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 261; 414 mg/9g; mg/9g 52686-284_34826613-d02f-4f03-b159-d59e967e9c98 52686-284 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION I00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g 52686-285_34826613-d02f-4f03-b159-d59e967e9c98 52686-285 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION I20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g 52686-286_34826613-d02f-4f03-b159-d59e967e9c98 52686-286 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION I40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g 52686-287_34826613-d02f-4f03-b159-d59e967e9c98 52686-287 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION I60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g 52686-288_34826613-d02f-4f03-b159-d59e967e9c98 52686-288 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION B20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g 52686-289_34826613-d02f-4f03-b159-d59e967e9c98 52686-289 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION B40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g 52686-290_34826613-d02f-4f03-b159-d59e967e9c98 52686-290 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION B60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g 52686-291_34826613-d02f-4f03-b159-d59e967e9c98 52686-291 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION O20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g 52686-292_34826613-d02f-4f03-b159-d59e967e9c98 52686-292 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION O40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g 52686-293_34826613-d02f-4f03-b159-d59e967e9c98 52686-293 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION O60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g 52686-294_34826613-d02f-4f03-b159-d59e967e9c98 52686-294 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION O80 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g 52686-295_6c038d6c-963c-450d-a823-94fdbc524f84 52686-295 HUMAN OTC DRUG SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP10 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 828; 660 mg/12g; mg/12g 52686-296_6c038d6c-963c-450d-a823-94fdbc524f84 52686-296 HUMAN OTC DRUG SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP20 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 828; 660 mg/12g; mg/12g 52686-297_6c038d6c-963c-450d-a823-94fdbc524f84 52686-297 HUMAN OTC DRUG SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP30 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 828; 660 mg/12g; mg/12g 52686-298_6c038d6c-963c-450d-a823-94fdbc524f84 52686-298 HUMAN OTC DRUG SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP40 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 828; 660 mg/12g; mg/12g 52686-299_6c038d6c-963c-450d-a823-94fdbc524f84 52686-299 HUMAN OTC DRUG SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP50 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 828; 660 mg/12g; mg/12g 52686-300_6c038d6c-963c-450d-a823-94fdbc524f84 52686-300 HUMAN OTC DRUG SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP60 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 828; 660 mg/12g; mg/12g 52686-301_6c038d6c-963c-450d-a823-94fdbc524f84 52686-301 HUMAN OTC DRUG SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP70 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 828; 660 mg/12g; mg/12g 52686-302_217c07d3-02c9-4bcb-91b1-ce9e0522a77e 52686-302 HUMAN OTC DRUG SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 10 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20020901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 209; 198 mg/11g; mg/11g 52686-303_217c07d3-02c9-4bcb-91b1-ce9e0522a77e 52686-303 HUMAN OTC DRUG SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 20 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20020901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 209; 198 mg/11g; mg/11g 52686-304_217c07d3-02c9-4bcb-91b1-ce9e0522a77e 52686-304 HUMAN OTC DRUG SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 30 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20020901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 209; 198 mg/11g; mg/11g 52686-305_217c07d3-02c9-4bcb-91b1-ce9e0522a77e 52686-305 HUMAN OTC DRUG SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 40 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20020901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 209; 198 mg/11g; mg/11g 52686-306_217c07d3-02c9-4bcb-91b1-ce9e0522a77e 52686-306 HUMAN OTC DRUG SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 50 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20020901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 209; 198 mg/11g; mg/11g 52686-307_217c07d3-02c9-4bcb-91b1-ce9e0522a77e 52686-307 HUMAN OTC DRUG SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 60 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20020901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 209; 198 mg/11g; mg/11g 52686-308_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-308 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION I00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-309_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-309 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION I20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-310_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-310 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION I40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-311_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-311 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION I60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-312_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-312 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION I100 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-313_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-313 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION B00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-314_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-314 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION B20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-315_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-315 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION B40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-316_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-316 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION B60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-317_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-317 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION B100 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-318_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-318 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION O00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-319_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-319 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION O20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-320_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-320 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION O40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-321_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-321 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION O60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-322_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-322 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION O80 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-323_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-323 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION BF40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-324_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-324 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION WB40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-325_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-325 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION WB60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g 52686-326_9b7b250e-c2b5-4a95-9d87-3054f762c3ba 52686-326 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION D10 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1220; 2081 mg/35.88g; mg/35.88g 52686-327_9b7b250e-c2b5-4a95-9d87-3054f762c3ba 52686-327 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION D20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1220; 2081 mg/35.88g; mg/35.88g 52686-328_9b7b250e-c2b5-4a95-9d87-3054f762c3ba 52686-328 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION D30 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1220; 2081 mg/35.88g; mg/35.88g 52686-329_2dab2b8a-a3fc-4aa0-af7d-7b058eed5722 52686-329 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX DAYTIME PROTECTIVE AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1255; 3715; 1004 mg/50.2g; mg/50.2g; mg/50.2g 52686-330_062eaceb-a0d3-43f0-9724-79a7cce3feb8 52686-330 HUMAN OTC DRUG SHISEIDO BENEFIANCE WRINKLERESIST24 DAY AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1289; 3815; 1031 mg/51.55g; mg/51.55g; mg/51.55g 52686-331_3ca083a5-8a34-4948-8040-9ce795929e80 52686-331 HUMAN OTC DRUG SHISEIDO BENEFIANCE WRINKLERESIST24 DAY AVOBENZONE, OCTINOXATE, and OCTOCRYLENE EMULSION TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1946; 5761; 1557 mg/77.85g; mg/77.85g; mg/77.85g 52686-332_4c15673e-85db-4cb5-9377-4c04e38d37be 52686-332 HUMAN OTC DRUG SHISEIDO BENEFIANCE NUTRIPERFECT DAY AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1286; 3807; 1029 mg/51.45g; mg/51.45g; mg/51.45g 52686-333_d84fe903-2eee-4f57-9188-a8917e3dceb6 52686-333 HUMAN OTC DRUG SHISEIDO THE SKINCARE DAY MOISTURE PROTECTION AVOBENZONE, OCTINOXATE, and OCTOCRYLENE EMULSION TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1935; 5728; 1548 mg/77.4g; mg/77.4g; mg/77.4g 52686-334_5f40b504-9e2e-4e63-8416-4b64345f8f28 52686-334 HUMAN OTC DRUG SHISEIDO THE SKINCARE DAY MOISTURE PROTECTION ENRICHED AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1316; 3896; 1053 mg/52.65g; mg/52.65g; mg/52.65g 52686-335_0801ab22-8145-4711-b95c-3b786b1ceafb 52686-335 HUMAN OTC DRUG SHISEIDO SUN PROTECTION EYE OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 479; 495; 1749 mg/16.5g; mg/16.5g; mg/16.5g 52686-336_afa33e91-1c60-42ce-a5f2-ccd6b966e05f 52686-336 HUMAN OTC DRUG SHISEIDO EXTRA SMOOTH SUN PROTECTION N OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 2766; 1694; 7056 mg/56.45g; mg/56.45g; mg/56.45g 52686-337_307eba82-c1c2-4c3f-8c26-ceaff8060262 52686-337 HUMAN OTC DRUG SHISEIDO EXTRA SMOOTH SUN PROTECTION N OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE LOTION TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 5424; 3321; 13.84 mg/110.7g; mg/110.7g; g/110.7g 52686-338_cb5b83cb-1075-4be4-b3bd-160db02ffa79 52686-338 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION TRANSLUCENT OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 441; 828 mg/9g; mg/9g 52686-339_d6a8c338-83d7-49e8-a66b-4f9014cc5bba 52686-339 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 1 ENSULIZOLE, OCTINOXATE, and TITANIUM DIOXIDE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 656; 2426; 2361 mg/32.79g; mg/32.79g; mg/32.79g 52686-340_d6a8c338-83d7-49e8-a66b-4f9014cc5bba 52686-340 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 2 ENSULIZOLE, OCTINOXATE, and TITANIUM DIOXIDE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 656; 2426; 2361 mg/32.79g; mg/32.79g; mg/32.79g 52686-341_d6a8c338-83d7-49e8-a66b-4f9014cc5bba 52686-341 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 3 ENSULIZOLE, OCTINOXATE, and TITANIUM DIOXIDE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 656; 2426; 2361 mg/32.79g; mg/32.79g; mg/32.79g 52686-342_72150c68-0cc5-4be8-9c6f-626499f72721 52686-342 HUMAN OTC DRUG SHISEIDO PERFECT HYDRATING BB MEDIUM ENSULIZOLE, OCTINOXATE, and TITANIUM DIOXIDE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 656; 2426; 2361 mg/32.79g; mg/32.79g; mg/32.79g 52686-343_72150c68-0cc5-4be8-9c6f-626499f72721 52686-343 HUMAN OTC DRUG SHISEIDO PERFECT HYDRATING BB DARK ENSULIZOLE, OCTINOXATE, and TITANIUM DIOXIDE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 656; 2426; 2361 mg/32.79g; mg/32.79g; mg/32.79g 52686-344_72150c68-0cc5-4be8-9c6f-626499f72721 52686-344 HUMAN OTC DRUG SHISEIDO PERFECT HYDRATING BB LIGHT ENSULIZOLE, OCTINOXATE, and TITANIUM DIOXIDE CREAM TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 656; 2426; 2361 mg/32.79g; mg/32.79g; mg/32.79g 52686-642_911a6e32-89eb-435f-87a2-ec754a627e73 52686-642 HUMAN OTC DRUG SHISEIDO SUN PROTECTION LIP TREATMENT OCTINOXATE and TITANIUM DIOXIDE LIPSTICK TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 296; 180 mg/4g; mg/4g 52686-677_b976cc21-abd7-4233-981a-65373e19b3d0 52686-677 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT UV PROTECTION Octinoxate, Octocrylene, and Zinc oxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 2.50047; 1.5309; 3.41901 g/51.03g; g/51.03g; g/51.03g 52686-677_f120e363-3b4b-41be-ad9d-b4af8c93d4e4 52686-677 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT UV PROTECTION Octinoxate, Octocrylene, and Zinc oxide CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 2.50047; 1.5309; 3.41901 g/51.03g; g/51.03g; g/51.03g 52695-001_f4acfb10-4639-42ec-9764-13ef4ea84941 52695-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19540101 UNAPPROVED MEDICAL GAS Humphries, Inc. OXYGEN 995 mL/L 52698-001_4c3704e7-e231-451f-8085-2d612c8bbe12 52698-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Bill Munn Supply Inc, dba Munn Supply OXYGEN 99 L/100L 52698-002_9df7cc95-67eb-45dd-94b5-9bf6cc55cde4 52698-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Bill Munn Supply Inc, dba Munn Supply NITROGEN 99 L/100L 52709-0801_0cbfb80a-db5c-45ce-b79d-80fde2ba8355 52709-0801 NON-STANDARDIZED ALLERGENIC HONEY BEE VENOM APIS MELLIFERA VENOM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 19921120 BLA BLA103969 ALK-Abello A S APIS MELLIFERA VENOM 120 ug/1 52709-0901_0cbfb80a-db5c-45ce-b79d-80fde2ba8355 52709-0901 NON-STANDARDIZED ALLERGENIC EASTERN YELLOWJACKET VENOM PROTEIN VESPULA MACULIFRONS VENOM PROTEIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 19921120 BLA BLA103974 ALK-Abello A S VESPULA MACULIFRONS VENOM PROTEIN 120 ug/1 Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 52709-1001_0cbfb80a-db5c-45ce-b79d-80fde2ba8355 52709-1001 NON-STANDARDIZED ALLERGENIC YELLOW HORNET VENOM PROTEIN DOLICHOVESPULA ARENARIA VENOM PROTEIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 19921120 BLA BLA103973 ALK-Abello A S DOLICHOVESPULA ARENARIA VENOM PROTEIN 120 ug/1 Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 52709-1101_0cbfb80a-db5c-45ce-b79d-80fde2ba8355 52709-1101 NON-STANDARDIZED ALLERGENIC WHITE FACED HORNET VENOM PROTEIN DOLICHOVESPULA MACULATA VENOM PROTEIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 19921120 BLA BLA103972 ALK-Abello A S DOLICHOVESPULA MACULATA VENOM PROTEIN 120 ug/1 Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 52709-1301_0cbfb80a-db5c-45ce-b79d-80fde2ba8355 52709-1301 NON-STANDARDIZED ALLERGENIC COMMON PAPER WASP VENOM PROTEIN POLISTES FUSCATUS VENOM PROTEIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 19921120 BLA BLA103971 ALK-Abello A S POLISTES FUSCATUS VENOM PROTEIN 120 ug/1 Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 52709-1401_0cbfb80a-db5c-45ce-b79d-80fde2ba8355 52709-1401 NON-STANDARDIZED ALLERGENIC Hymenoptera Venom Diagnostic Hymenoptera Venom Diagnostic KIT 19921120 BLA BLA123456 ALK-Abello A S 52725-490_986c60c0-7d75-11e0-b654-0002a5d5c51b 52725-490 HUMAN PRESCRIPTION DRUG Fenoglide fenofibrate TABLET ORAL 20101118 NDA NDA022118 Shore Therapeutics, Inc FENOFIBRATE 40 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 52725-495_986c60c0-7d75-11e0-b654-0002a5d5c51b 52725-495 HUMAN PRESCRIPTION DRUG Fenoglide fenofibrate TABLET ORAL 20101118 NDA NDA022118 Shore Therapeutics, Inc FENOFIBRATE 120 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 52726-4083_95525633-2d4d-44ee-8610-0b6af0be7170 52726-4083 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Mercy Home Respiratory Care and Medical Supply OXYGEN 99 L/100L 52731-7001_141be593-4a9b-41b9-9f36-985a58b38144 52731-7001 HUMAN OTC DRUG Flu Complex Aconitum napellus, Belladonna, Bryonia, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Phosphorus, Phytolacca decandra, Veratrum viride LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; VERATRUM VIRIDE ROOT 4; 6; 4; 4; 8; 12; 6; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7002_b0a40991-b9be-4194-b3f4-9fba1292e267 52731-7002 HUMAN OTC DRUG Cold Complex Aconitum napellus, Apis mellifica, Belladonna, Calcarea carbonica, Echinacea angustifolia, Euphorbium officinarum, Kali bichronicum, Natrum muriaticum, Nux vomica, Pulsatilla LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPHORBIA RESINIFERA RESIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 4; 4; 6; 4; 6; 8; 6; 6; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7003_c29317f3-0231-417a-9874-cf1ad13244a2 52731-7003 HUMAN OTC DRUG Sinus Complex Antimonium tartaricum, Echinacea angustifolia, Euphorbium officinarum, Hepar sulphuris calcareum, Hepatica tribola, Hydrastis canadensis, Mercurius sulfuratus ruber, Natrum muriaticum, Phosphorus LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ANTIMONY POTASSIUM TARTRATE; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA; EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; HEPATICA NOBILIS VAR. OBTUSA; MERCURIC SULFIDE; PHOSPHORUS; SODIUM CHLORIDE 6; 8; 4; 6; 4; 4; 10; 12; 12 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7004_eb65a6a0-ea22-47b6-b99a-465efddc0022 52731-7004 HUMAN OTC DRUG Throat Complex Ammonium carbonicum, Apis mellifica, Arum maculatum, Baryta carbonica, Bromium, Hepar sulphuris calcareum, Lachesis mutus, Mercurius cyanatus, Phytolacca decandra LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. AMMONIUM CARBONATE; APIS MELLIFERA; ARUM MACULATUM ROOT; BARIUM CARBONATE; BROMINE; CALCIUM SULFIDE; LACHESIS MUTA VENOM; MERCURIC CYANIDE; PHYTOLACCA AMERICANA ROOT 6; 4; 4; 10; 6; 8; 10; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7005_b5118f88-1dcd-4dc7-9488-3a1cff4bb584 52731-7005 HUMAN OTC DRUG Respiratory Complex Antimonium tartaricum, Bryonia, Chelidonium majus, Echinacea angustifolia, Hepar sulphuris calcareum, Hepatica tribola, Lycopodium clavatum, Phosphorus, Stannum metallicum, Sticta pulmonaria LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; HEPATICA NOBILIS VAR. OBTUSA; LOBARIA PULMONARIA; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TIN 6; 4; 8; 6; 4; 4; 4; 6; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7006_80b26a64-a12d-4936-84e8-e592452669ed 52731-7006 HUMAN OTC DRUG Asthma Complex Berberis vulgaris, Cactus grandiflorus, Carbo vegetabilis, Chelidonium majus, Cuprum aceticum, Curare, Dulcamara, Ignatia amara, Strophanthus hispidus LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACTIVATED CHARCOAL; BERBERIS VULGARIS FRUIT; CHELIDONIUM MAJUS; CUPRIC ACETATE; SELENICEREUS GRANDIFLORUS FLOWER; SOLANUM DULCAMARA TOP; STROPHANTHUS HISPIDUS SEED; STRYCHNOS IGNATII SEED; TUBOCURARINE CHLORIDE 12; 6; 6; 4; 4; 6; 4; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7007_fc491732-e324-43b4-8e60-164c5d3ed820 52731-7007 HUMAN OTC DRUG Allergy Complex Apis mellifica, Arundo mauritanica, Euphorbium officinarum, Euphrasia officinalis, Hydrastis canadensis, Ipecacuanha, Luffa operculata, Sabadilla, Sanguinaria canadensis, Sulfur LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. APIS MELLIFERA; ARUNDO PLINIANA ROOT; EUPHORBIA RESINIFERA RESIN; EUPHRASIA STRICTA; GOLDENSEAL; IPECAC; LUFFA OPERCULATA FRUIT; SANGUINARIA CANADENSIS ROOT; SCHOENOCAULON OFFICINALE SEED; SULFUR 4; 6; 6; 6; 4; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7008_29d40708-cf65-4c84-bd0c-0d62858ae8a8 52731-7008 HUMAN OTC DRUG Ear Complex Belladonna, Calcarea carbonica, Chamomilla, Echinacea angustifolia, Ferrum phosphoricum, Hepar sulphuris calcareum, Mercurius solubilis, Pulsatilla LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ATROPA BELLADONNA; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA; FERRUM PHOSPHORICUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS 6; 8; 4; 8; 6; 12; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7009_277a100d-4bf6-426b-bc88-244e52263e21 52731-7009 HUMAN OTC DRUG Teething Complex Belladonna, Calcarea carbonica, Calcarea fluorica, Chamomilla, Ferrum phosphoricum, Kreosotum, Podophyllum peltatum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ATROPA BELLADONNA; CALCIUM FLUORIDE; FERRUM PHOSPHORICUM; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PODOPHYLLUM; WOOD CREOSOTE 12; 12; 12; 4; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7010_5e059829-b0ca-468a-b60a-b71f80025fe4 52731-7010 HUMAN OTC DRUG Depression Complex Arsenicum album, Aurum metallicum, Ignatia amara, Kali phosphoricum, Phosforicum acidum, Pulsatilla, Rhus toxicodendron LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ARSENIC TRIOXIDE; GOLD; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; STRYCHNOS IGNATII SEED; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 52731-7011_6514aa3a-35ec-43eb-81b4-3043c1f0985f 52731-7011 HUMAN OTC DRUG Stress Complex Anacardium orientale, Berberis vulgaris, Natrum muriaticum, Nitricum acidum, Nux vomica, Staphysagria, Sulphur, Thuja occidentalis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. BERBERIS VULGARIS ROOT BARK; DELPHINIUM STAPHISAGRIA SEED; NITRIC ACID; SEMECARPUS ANACARDIUM JUICE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12; 12; 12; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 52731-7012_b51ca425-9ff5-4eb1-a91a-660cef13fe12 52731-7012 HUMAN OTC DRUG Headache Complex Aconitum napellus, Bryonia, Cactus grandiflorus, Chelidonium majus, Cimicifuga racemosa, Sanguinaria canadensis, Spigelia anthelmia, Thuja occidentails LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACONITUM NAPELLUS; BLACK COHOSH; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; SANGUINARIA CANADENSIS ROOT; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; THUJA OCCIDENTALIS LEAFY TWIG 12; 6; 12; 6; 6; 4; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7014_0d52cbf3-1962-4ee4-8aae-091a0397b417 52731-7014 HUMAN OTC DRUG Cough Complex Antimonium tartaricum, Belladonna, Bryonia,Causticum, Coccus cacti, Cuprum aceticum, Drosera rotundifolia, Kreosotum, Lobelia inflata, Pulsatilla, Stannum metallicum, Sticta pulmonaria LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAUSTICUM; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; LOBARIA PULMONARIA; LOBELIA INFLATA; PROTORTONIA CACTI; PULSATILLA VULGARIS; TIN; WOOD CREOSOTE 4; 4; 4; 6; 4; 6; 4; 3; 4; 4; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7015_61e7dc9b-0c71-4a4c-8ce2-804635196890 52731-7015 HUMAN OTC DRUG Diarrhea Complex Aloe socotrina, Arsenicum album, Bryonia, Collinsonia canadensis, Colocynthis, Croton tiglium, Cuprum aceticum, Echinacea angustifolia, Mercurius sub. corros, Rheum officinale, Sulfur, Veratrum album LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ALOE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; COLLINSONIA CANADENSIS ROOT; CROTON TIGLIUM SEED; CUPRIC ACETATE; ECHINACEA ANGUSTIFOLIA; MERCURIC CHLORIDE; RHEUM OFFICINALE ROOT; SULFUR; VERATRUM ALBUM ROOT 4; 6; 4; 4; 3; 4; 4; 3; 6; 3; 8; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7016_36a06a39-7cb7-41c7-8c95-d6a7cd0b26f2 52731-7016 HUMAN OTC DRUG Exhaustion Complex Berberis vulgaris, China officinalis, Kali phosphoricum, Nux vomica, Picricum acidum, Stannum metallicum, Zincum metallicum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. BERBERIS VULGARIS ROOT BARK; CINCHONA PUBESCENS BARK; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; TIN; TRINITROPHENOL; ZINC 4; 4; 12; 12; 8; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7017_2d344902-2fc3-4447-b08e-30967b3986b7 52731-7017 HUMAN OTC DRUG Hemorrhoid Complex Aesculus hippocastanum, Aloe socotrina, Apis mellifica, Bryonia, Calcarea fluorica, Carbo vegetabilis, Causticum, Collinsonia canadensis, Echinacea angustifolia, Hamamelis virginiana, Lycopodium clavatum, Sulphur LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACTIVATED CHARCOAL; ALOE; APIS MELLIFERA; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; LYCOPODIUM CLAVATUM SPORE; SULFUR 10; 4; 4; 4; 8; 6; 3; 3; 3; 3; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7018_0d052c7e-ad3f-41f7-a29f-6159000a9d5b 52731-7018 HUMAN OTC DRUG Indigestion Complex Alumina, Anacardium orientale, Atropinum sulphuricum, Berberis vulgaris, Capsicum annuum, Carbo vegetabilis, Ignatia amara, Lycopodium clavatum, Nux vomica, Robinia pseud., Sulphuricum acidum, Valeriana officinalis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACTIVATED CHARCOAL; ALUMINUM OXIDE; ATROPINE SULFATE; BERBERIS VULGARIS ROOT BARK; CAPSICUM; LYCOPODIUM CLAVATUM SPORE; ROBINIA PSEUDOACACIA BARK; SEMECARPUS ANACARDIUM JUICE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFURIC ACID; VALERIAN 10; 8; 6; 4; 4; 4; 4; 6; 6; 4; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7019_cfd72d71-8db2-4e7e-b8e5-da24787cc8ee 52731-7019 HUMAN OTC DRUG Injury/Trauma Complex Aesculus hippocastanum, Apis mellifica, Arnica montana, Bellis perennis, Berberis vulgaris, Calendula officinalis, Echinacea angustifolia, Hamamelis virginiana, Hypericum perforatum, Millefolium, Ruta graveolens, Symphytum officinale LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACHILLEA MILLEFOLIUM; APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY LEAF; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP 3; 4; 3; 3; 4; 3; 3; 3; 3; 4; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7020_552509d3-3b35-4ea8-ae8a-cdffb8de0c72 52731-7020 HUMAN OTC DRUG PMS Complex Apis mellifica, Atropinum sulphuricum, Calcarea carbonica, Caulophyllum thalictroides, Colocynthis, Cuprum aceticum, Gelsemium sempervirens, Hamamelis virginiana, Helonias Dioica, Ignatia amara, Nux vomica, Pulsatilla, Stannum metalicum, Viburnum opulus LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. APIS MELLIFERA; ATROPINE SULFATE; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC ACETATE; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TIN; VIBURNUM OPULUS BARK 4; 6; 4; 4; 4; 4; 4; 3; 12; 12; 12; 12; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7021_40284a04-2843-435d-a463-ca74bd99aa4b 52731-7021 HUMAN OTC DRUG Lower Back Complex Ammonium muriaticum, Apis mellifica, Berberis vulgaris, Causticum, Chelidonium majus, Colocynthis, Cuprum aceticum, Gnaphalium poly., Nux vomica, Phytolacca decandra, Rhus toxicodendron, Stannum metallicum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. AMMONIUM CHLORIDE; APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; CAUSTICUM; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC ACETATE; PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; STRYCHNOS NUX-VOMICA SEED; TIN; TOXICODENDRON PUBESCENS LEAF 8; 4; 4; 6; 4; 4; 4; 6; 6; 6; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7022_cba35ca6-3cf3-4b51-918c-e1a789ba780a 52731-7022 HUMAN OTC DRUG Shoulder/Arm Complex Berberis vulgaris, Calcarea carbonica, Carboneum sulphuratum, Causticum, Cimicifuga racemosa, Cuprum aceticum, Ferrum metallicum, Kali phosphoricum, Ruta graveolens, Silicea, Spigelia anthelmia, Spiraea ulmaria LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CARBON DISULFIDE; CAUSTICUM; CUPRIC ACETATE; FILIPENDULA ULMARIA ROOT; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM PHOSPHATE, DIBASIC; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SPIGELIA ANTHELMIA 4; 6; 6; 6; 4; 4; 8; 8; 8; 4; 8; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7023_35945241-a319-4ff1-b703-0d2b3b59dc1e 52731-7023 HUMAN OTC DRUG Skin Rash Complex Apis mellifica, Arnica montana, Belladonna, Calendula officinalis, Chelidonium majus, Echinacea angustifolia, Hepar sulphuris calcareum, Ipecacuanha, Ledum palustre, Rhus toxicodendron, Staphisagria, Urtica urens LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA ANGUSTIFOLIA; IPECAC; LEDUM PALUSTRE TWIG; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 4; 4; 6; 10; 3; 4; 6; 3; 4; 4; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7024_25142970-f557-430e-a952-6ec1616eb5d3 52731-7024 HUMAN OTC DRUG Sport Injury Complex Apis mellifica, Arnica montana, Bryonia, Colchicum autumnale, Colocynthis, Cuprum aceticum, Ledum paustre, Petroleum, Ruta graveolens, Silicea, Stannum metallicum, Zincum metallicum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. APIS MELLIFERA; ARNICA MONTANA; BRYONIA ALBA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; CUPRIC ACETATE; LEDUM PALUSTRE TWIG; LIQUID PETROLEUM; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; TIN; ZINC 4; 3; 4; 4; 4; 4; 4; 6; 4; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7025_5ca4be61-0d88-4635-bf1f-c65587f33162 52731-7025 HUMAN OTC DRUG Burn Complex Aconitum napellus 12X, Apis mellifica 4X, Arnica montana 3X, Berberis vulgaris 4X, Calendula officinalis 3X, Cantharis 4X, Carbo vegetabilis 12X, Causticum 3X, Echinacea angustifolia 3X,Glonoinum 6X, LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACONITUM NAPELLUS; ACTIVATED CHARCOAL; APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; LYTTA VESICATORIA; NITROGLYCERIN; URTICA URENS 12; 12; 4; 3; 4; 3; 3; 3; 3; 4; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7026_ca091774-e428-44a7-9e81-dc4b4de273ff 52731-7026 HUMAN OTC DRUG Air Pollution Complex Arnica montana 6X, Bovista 6X, Calcarea carbonica 8X,Carbo vegetabilis 8X, Cicuta virosa 6X, Euphorbium officinarum 6X,Hydrastis canadensis 4X, Petroleum 6X, Phosphorus 8X, Plumbum metallicum 8X, Sulf LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACTIVATED CHARCOAL; ARNICA MONTANA; CICUTA VIROSA ROOT; EUPHORBIA RESINIFERA RESIN; GIANT PUFFBALL; GOLDENSEAL; LEAD; LIQUID PETROLEUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SULFUR 8; 6; 6; 6; 6; 4; 8; 6; 8; 8; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7027_14038e6c-a314-4a50-947b-27e94a40186f 52731-7027 HUMAN OTC DRUG Bloating Complex Allium Cepa, Argentum nitricum, Carbo vegetabilis, China officinalis, Crocus sativus, Kali carbonicum, Magnesia phosphorica, Momordica balsamina LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACTIVATED CHARCOAL; CINCHONA PUBESCENS BARK; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MOMORDICA BALSAMINA IMMATURE FRUIT; ONION; POTASSIUM CARBONATE; SAFFRON; SILVER NITRATE 8; 4; 8; 4; 4; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7028_af718a41-07eb-4353-85f0-acb6c85597de 52731-7028 HUMAN OTC DRUG Circulation Complex Aesculus hippocastanum, Arnica montana, Baryta carbonica, Belladonna, Calcarea carbonica, Chelidonium majus, China officinalis, Glonoinum, Sepia, Strophanthus hispidus LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ARNICA MONTANA; ATROPA BELLADONNA; BARIUM CARBONATE; CHELIDONIUM MAJUS; CINCHONA PUBESCENS BARK; HORSE CHESTNUT; NITROGLYCERIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE; STROPHANTHUS HISPIDUS SEED 4; 6; 8; 4; 4; 3; 6; 8; 10; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7029_057d8bae-8d35-46d4-ba26-59ce2373c7c9 52731-7029 HUMAN OTC DRUG Cold Sore Complex Bryonia, Calcarea sulfurica, Clematis erecta, Graphites, Lycopodium clavatum, Natrum carbonicum, Natrum muriaticum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. BRYONIA ALBA ROOT; CALCIUM SULFATE ANHYDROUS; CLEMATIS RECTA FLOWERING TOP; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM CHLORIDE 6; 8; 6; 12; 12; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7030_4488ff62-8f05-42a3-b175-5fb81db8a008 52731-7030 HUMAN OTC DRUG Colic Complex Belladonna, Chamomilla, Colocynthis, Dioscorea villosa, Lacticum acidum, Magnesia phosphorica, Momordica balsamina, Plumbum metallicum, Stannum metallicum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ATROPA BELLADONNA; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA ROOT; LACTIC ACID, DL-; LEAD; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; MOMORDICA BALSAMINA IMMATURE FRUIT; TIN 6; 6; 6; 4; 8; 8; 4; 4; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7031_b560a5ff-c533-43ab-9412-a3a2a014f0fd 52731-7031 HUMAN OTC DRUG Fever Complex Aconitum napellus, Arnica montana, Baptisia tinctoria, Berberis vulgaris, Cactus grandiflorus,Chelidonium majus, Echinacea angustifolia, Ferrum phosphoricum, Hepar sulfuris calcareum, Urtica urens LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; FERRUM PHOSPHORICUM; SELENICEREUS GRANDIFLORUS STEM; URTICA URENS 6; 6; 4; 4; 8; 6; 2; 8; 6; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7032_e2c560dd-5bc4-490e-9db9-80e68ede846d 52731-7032 HUMAN OTC DRUG Infection Complex Apis mellifica, Argentum Nitricum., Arnica montana, Belladonna, Berberis vulgaris, Bryonia, Calcarea sulfurica, Echinacea angustifolia, Echinacea purpurea, Ferrum phosphoricum, Hepar sulphuris calcareum, Pulsatilla LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALCIUM CATION; CALCIUM CATION; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; FERRUM PHOSPHORICUM; PULSATILLA VULGARIS; SILVER CATION 4; 4; 6; 4; 6; 8; 8; 2; 2; 8; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7033_e722c718-2334-463e-a24d-f8c9f70dcb88 52731-7033 HUMAN OTC DRUG Joint Complex Aconitum napellus, Bryonia, Colchicum autumnale, Colocynthis, Dulcamara, Echinacea angustifolia, Formica, Ledum Palustre, Rhus toxicodendron, Ruta graveolens, Silicea, Sticta pulmonaria LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; ECHINACEA ANGUSTIFOLIA; FORMICA RUFA; LEDUM PALUSTRE TWIG; LOBARIA PULMONARIA; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SOLANUM DULCAMARA STEM; TOXICODENDRON PUBESCENS LEAF 6; 4; 6; 6; 2; 4; 4; 4; 4; 8; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7035_91a6c4b2-cb83-4bea-8195-492f45a3366a 52731-7035 HUMAN OTC DRUG Lymphatic Complex Baryta carbonica, Berberis vulgaris, Calcarea carbonica, Chelidonium majus, Clematis erecta, Echinacea angustifolia, Galium aparine, Graphites, Juglans regia, Spongia tosta, Thuja occidentalis, Urtica urens LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; CLEMATIS RECTA FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; GRAPHITE; JUGLANS REGIA FRUIT RIND, IMMATURE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SPONGIA OFFICINALIS SKELETON, ROASTED; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 8; 4; 6; 6; 2; 4; 12; 6; 12; 12; 4; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7036_1c17bc1d-0e1f-499b-a6f4-a754c2f2c60a 52731-7036 HUMAN OTC DRUG Male Complex Cantharis, Chimaphila umbellata, Echinacea angustifolia, Pareira brava, Pulsatilla, Sabal Serrulata, Secale cornutum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. CHIMAPHILA UMBELLATA; CHONDRODENDRON TOMENTOSUM ROOT; CLAVICEPS PURPUREA SCLEROTIUM; ECHINACEA ANGUSTIFOLIA; LYTTA VESICATORIA; PULSATILLA VULGARIS; SAW PALMETTO 4; 4; 6; 4; 4; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7037_6a31a84b-a86f-46a6-8e0c-fb2153bc9314 52731-7037 HUMAN OTC DRUG Menopause Complex Belladonna, Calcarea carbonica, China officinalis, Glonoinum, Lilium Tigrinum, Platinum metallicum, Pulsatilla, Sanguinaria canadensis, Stannum metallicum, Sulfur LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ATROPA BELLADONNA; CINCHONA PUBESCENS BARK; LILIUM LANCIFOLIUM FLOWERING TOP; NITROGLYCERIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PLATINUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SULFUR; TIN 12; 6; 6; 8; 12; 10; 12; 6; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7038_121aa97d-d378-4e5e-b697-8dbb3e48d2d0 52731-7038 HUMAN OTC DRUG Menstrual Cramp Complex Aesculus hippocastanum, Belladonna, Berberis vulgaris, Cactus grandiflorus, Chamomilla, China officinalis, Cuprum aceticum, Hyoscyamus niger, Kali carbonicum, Magnesia phosphorica, Pulsatilla, Stannum metallicum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; CINCHONA PUBESCENS BARK; CUPRIC ACETATE; HORSE CHESTNUT; HYOSCYAMUS NIGER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SELENICEREUS GRANDIFLORUS STEM; TIN 6; 4; 6; 4; 4; 6; 8; 4; 6; 12; 4; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [iU]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7040_45394af8-a830-47ab-a417-3560f1828258 52731-7040 HUMAN OTC DRUG Muscle Cramp Complex Anacardium orientale, Belladonna, Cactus grandiflorus, Calcarea carbonica, Carboneum sulphuratum, Cuprum aceticum, Magnesia phosphorica, Secale cornutum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ATROPA BELLADONNA; CARBON DISULFIDE; CLAVICEPS PURPUREA SCLEROTIUM; CUPRIC ACETATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SELENICEREUS GRANDIFLORUS STEM; SEMECARPUS ANACARDIUM JUICE 6; 10; 6; 4; 8; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7041_4e917dd3-32f4-4ef0-a85d-0594fd8910ce 52731-7041 HUMAN OTC DRUG Nervousness Complex Argentum nitricum, Belladonna, Cantharis, Chamomilla, Glonoinum, Kali bromatum, Phosphorus, Sepia, Valeriana officinalis, Zincum metallicum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ATROPA BELLADONNA; LYTTA VESICATORIA; MATRICARIA RECUTITA; NITROGLYCERIN; PHOSPHORUS; POTASSIUM BROMIDE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; VALERIAN; ZINC 12; 12; 6; 6; 5; 6; 6; 12; 3; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 52731-7042_820d65ca-2a0c-48d6-9211-4705dfc784f8 52731-7042 HUMAN OTC DRUG Phobia Complex Aconitum napellus, Argentum nitricum, Arnica montana, Valeriana officinalis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; SILVER NITRATE; VALERIAN 12; 12; 12; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 52731-7043_a352f130-dbdc-4db1-95ec-9914be14129d 52731-7043 HUMAN OTC DRUG Anxiety Complex Ambra grisea, Argentum nitricum, Aurum metallicum, Kali phosphoricum, Valeriana officianalis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. AMBERGRIS; GOLD; POTASSIUM PHOSPHATE, DIBASIC; SILVER NITRATE; VALERIAN 6; 12; 6; 12; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 52731-7044_a0e35a74-d2ee-45dd-9aa8-9c6e1032ff8e 52731-7044 HUMAN OTC DRUG Toothache Complex Aconitum napellus, Chamomilla, Hekla lava, Magnesia carbonica, Mezereum, Phytolacca decandra, Silicea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACONITUM NAPELLUS; DAPHNE MEZEREUM BARK; HEKLA LAVA; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE 12; 12; 12; 12; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7045_e8faecca-d82e-4017-9b7d-7faf36f41255 52731-7045 HUMAN OTC DRUG Varicose Vein Complex Aesculus hippocastanum, Arnica montana, Berberis vulgaris, Carbo vegetabilis, Echinacea angustifolia, Hamamelis virginiana, Hydrofluoricum acidum, Lycopodium clavatum, Secale cornutum, Sulfur LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACTIVATED CHARCOAL; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; CLAVICEPS PURPUREA SCLEROTIUM; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROFLUORIC ACID; LYCOPODIUM CLAVATUM SPORE; SULFUR 8; 4; 4; 6; 2; 4; 4; 8; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7047_15fc298f-0589-46be-82c5-f4659f6f494e 52731-7047 HUMAN OTC DRUG Vision Complex Aurum metallicum, Belladonna, Cactus grandiflorus, China officinalis, Conium maculatum, Curare, Gelsemium sempervirens, Phosphorus, Ruta graveolens, Veratrum album LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ATROPA BELLADONNA; CINCHONA PUBESCENS BARK; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLD; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; SELENICEREUS GRANDIFLORUS STEM; TUBOCURARINE CHLORIDE; VERATRUM ALBUM ROOT 12; 8; 8; 12; 12; 10; 6; 4; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7048_eb2e59f5-78f8-4e11-b15c-3ccffba82b73 52731-7048 HUMAN OTC DRUG Leg Cramp Complex Calcarea carbonica, Colocynthis, Cuprum aceticum, Lacticum acidum, Rhus toxicodendron, Secale cornutum, Veratrum album LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. CITRULLUS COLOCYNTHIS FRUIT PULP; CLAVICEPS PURPUREA SCLEROTIUM; CUPRIC ACETATE; LACTIC ACID, DL-; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 4; 6; 4; 6; 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7049_c5c67cd2-ef55-49e5-878b-466470134ae1 52731-7049 HUMAN OTC DRUG Relaxation Complex Anacardium, Calcerea carbonica, Hypericum, Magnesia phosphorica, Piper methysticum, Ruta graveolens, Silicea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PIPER METHYSTICUM ROOT; RUTA GRAVEOLENS FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; ST. JOHN'S WORT 8; 8; 3; 4; 30; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7050_26b8fa80-39aa-4204-990c-8d97d4598e96 52731-7050 HUMAN OTC DRUG Bladder Complex Apis mellifica, Belladonna, Berberis vulgaris, Cantharis, Echinacea ang, Equissetum avense, Hydrastis, Mercurius solubilis, Pulsatilla, Staphysagria LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. APIS MELLIFERA; ATROPA BELLADONNA; BERBERIS VULGARIS FRUIT; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA ANGUSTIFOLIA; EQUISETUM ARVENSE TOP; GOLDENSEAL; LYTTA VESICATORIA; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS 4; 6; 4; 6; 2; 6; 4; 4; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7051_ad047388-eea1-4135-b577-7d7d9f9734c9 52731-7051 HUMAN OTC DRUG Colon Complex Anacardium, Hepar sulfuis calcareum, Magnesia muriatica, Nux vomica, Platinum met., Plumbum met., Sepia LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. CALCIUM SULFIDE; LEAD; MAGNESIUM CHLORIDE; PLATINUM; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED 12; 30; 8; 12; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7052_1117244c-0251-4300-8eea-9bbc31423cb5 52731-7052 HUMAN OTC DRUG Defense Complex Berberis vulgaris, Galium aparine, Hydrastis, Lappa major, Solidago, Thuja occidentalis, Trifolium pratense, Urtica urens LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. BERBERIS VULGARIS ROOT BARK; GALIUM APARINE; GOLDENSEAL; SOLIDAGO VIRGAUREA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; TRIFOLIUM PRATENSE FLOWER; URTICA URENS 6; 6; 6; 4; 30; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52731-7053_dd967d8b-97b1-4071-8abf-a85bf1e4b5ec 52731-7053 HUMAN OTC DRUG Liver Complex Carduus marianus, Chelidonium majus, Cynara scolymus, Kali carbonicum, Lycopodium, Phosphorus, Taraxacum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. CHELIDONIUM MAJUS; CYNARA SCOLYMUS LEAF; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; POTASSIUM CARBONATE; SILYBUM MARIANUM SEED; TARAXACUM PALUSTRE ROOT 4; 4; 6; 12; 8; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 52747-110_d475cf07-2493-428e-a553-9466d2a12bae 52747-110 HUMAN PRESCRIPTION DRUG Divista Chromium Picolinate CAPSULE ORAL 20100710 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation BIOTIN; CHROMIUM PICOLINATE; CYANOCOBALAMIN; FOLIC ACID; OMEGA-3-ACID ETHYL ESTERS; PYRIDOXINE 2; 1000; 15; 1; 300; 25 mg/1; ug/1; ug/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 52747-475_0333f0f6-862e-159d-e054-00144ff88e88 52747-475 HUMAN OTC DRUG Norel AD acetaminophen, chlorpheniramine maleate, and phenylephrine HCl TABLET, MULTILAYER ORAL 20120427 OTC MONOGRAPH FINAL part341 US Pharmaceutical Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 4; 10 mg/1; mg/1; mg/1 52747-480_51fa1666-3a2d-401c-afc2-85641bd92258 52747-480 HUMAN OTC DRUG NorelCS CS Chlorpheniramine Maleate/Dextromethorphan Hydrobromide/Phenylephrine Hydrochloride LIQUID ORAL 20120801 OTC MONOGRAPH FINAL part341 US Pharmaceutical Corporation CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 12.5; 10 mg/5mL; mg/5mL; mg/5mL 52747-620_6d0aebcd-c00d-48ea-9690-5c466810d4a3 52747-620 HUMAN PRESCRIPTION DRUG Concept OB Vitamin Mineral Supplement CAPSULE ORAL 20090101 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; IRON; MAGNESIUM SULFATE; MANGANESE SULFATE; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC SULFATE 210; 300; 7; 800; 10; 130; 1; 92.4; 6.9; 1.3; 20; 25; 5; 5; 18.2 mg/1; ug/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 52747-621_de12d125-2cc8-4993-817c-8663b5b7e1f2 52747-621 HUMAN PRESCRIPTION DRUG Concept DHA Vitamin- Mineral Omega-3 Supplement CAPSULE, LIQUID FILLED ORAL 20090624 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; IRON; MAGNESIUM SULFATE; NIACIN; OMEGA-3-ACID ETHYL ESTERS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC SULFATE 25; 300; 5; 2; 12.5; 53.5; 1; 38; 5; 1.8; 200; 25; 3; 2; 10 mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 52747-711_61d8deac-80ef-45b0-b812-6c824bd1a869 52747-711 HUMAN PRESCRIPTION DRUG Integra F Ferrous Fumarate and Polysacchride Iron Complex and Folic Acid CAPSULE ORAL 20090427 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation ASCORBIC ACID; FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE; FOLIC ACID; NIACIN 40; 135.9; 191.2; 1; 3 mg/1; mg/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 52747-712_d8d20e53-d247-46a1-b572-8b541e453051 52747-712 HUMAN PRESCRIPTION DRUG Integra Plus Ferrous Fumarate and Polysacchride Iron Vitamin Mineral Complex Supplement CAPSULE ORAL 20090427 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE; FOLIC ACID; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE 210; 300; 7; 135.9; 191.2; 1; 20; 25; 5; 5 mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 52747-900_6f3280b9-49e3-4ff2-9c07-80bd1fded4e4 52747-900 HUMAN PRESCRIPTION DRUG Tandem Ferrous Fumarate and Polysacchride Iron Complex CAPSULE ORAL 20060217 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE 115.2; 162 mg/1; mg/1 52747-901_6f3280b9-49e3-4ff2-9c07-80bd1fded4e4 52747-901 HUMAN PRESCRIPTION DRUG Tandem - F Ferrous Fumarate and Polysacchride Iron Complex and Folic Acid CAPSULE ORAL 20060617 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE; FOLIC ACID 115.2; 162; 1 mg/1; mg/1; mg/1 52747-902_6f3280b9-49e3-4ff2-9c07-80bd1fded4e4 52747-902 HUMAN PRESCRIPTION DRUG Tandem Plus Ferrous Fumarate and Polysacchride Iron Vitamin Mineral Complex Supplement CAPSULE ORAL 20060617 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation CALCIUM PANTOTHENATE; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE 10; .8; 15; 115.2; 162; 1; 1.3; 30; 5; 6; 200; 10; 18.2 mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 52747-903_92dfaad9-48e9-4b3c-9e8e-18844a3fd6e5 52747-903 HUMAN PRESCRIPTION DRUG Tandem OB Vitamin Mineral Supplement CAPSULE ORAL 20060617 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation CALCIUM PANTOTHENATE; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; IRON; MAGNESIUM SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE 10; .8; 15; 162; 1; 115.2; 1.3; 30; 5; 6; 200; 10 mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 52747-904_44897973-0aca-45f0-a4cc-f414635d2fd6 52747-904 HUMAN PRESCRIPTION DRUG Tandem DHA Vitamin- Mineral Omega-3 Supplement CAPSULE ORAL 20070117 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation ASCORBIC ACID; FERROUS FUMARATE; FOLIC ACID; IRON; OMEGA-3-ACID ETHYL ESTERS; PYRIDOXINE HYDROCHLORIDE 20; 15; 1; 15; 310.1; 25 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 52751-001_9ec995c2-2679-4a7c-9443-11d3aca4b3ea 52751-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20100801 UNAPPROVED MEDICAL GAS Rezk Medical Supply OXYGEN 99 L/100L 52755-100_cdf9f494-8370-47dc-8ff0-dd404b66a87f 52755-100 HUMAN OTC DRUG Coralite Extra Strength Menthol Pain Relief Sleeve - KNEE MENTHOL LOTION TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part348 Shanghai Aquagel Bio-polymer Co., Ltd MENTHOL 16 mL/100mL 52755-200_7c53dcfa-7a6f-4735-8ad7-fcfe8d3d37a3 52755-200 HUMAN OTC DRUG Coralite Extra Strength Menthol Pain Relief Sleeve - WRIST MENTHOL LOTION TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part348 Shanghai Aquagel Bio-polymer Co., Ltd MENTHOL 16 mL/100mL 52755-300_0bc11984-5281-42be-b987-bdd06fa11bb0 52755-300 HUMAN OTC DRUG Coralite Topical Analgesic Capsaicin Heat CAPSAICIN LIQUID TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part348 Shanghai Aquagel Bio-polymer Co., Ltd CAPSAICIN .025 g/100g 52755-400_add688eb-e595-48be-8421-0644a5a7dd99 52755-400 HUMAN OTC DRUG Isopropyl Alcohol Swabs isopropyl alcohol SWAB TOPICAL 20130724 OTC MONOGRAPH NOT FINAL part333A Shanghai Aquagel Bio-polymer Co., Ltd. ISOPROPYL ALCOHOL 70 g/100g 52759-922_03f8b1ac-56c8-4234-bc83-d360ba1596d3 52759-922 HUMAN OTC DRUG Oosafe Benzalkonium Chloride LIQUID TOPICAL 20120430 OTC MONOGRAPH NOT FINAL part333A SPARMED ApS BENZALKONIUM CHLORIDE 1.3 g/L 52763-401_037a88e8-fc19-41fe-ba78-e3d561ea510b 52763-401 HUMAN OTC DRUG LidoCream 4 Lidocaine CREAM TOPICAL 20101201 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 4 g/100g 52763-401_d24ddc64-3588-4bff-a2f1-022eb16717e5 52763-401 HUMAN OTC DRUG LidoCream 4 Lidocaine CREAM TOPICAL 20101201 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 4 g/100g 52763-501_3596d891-41a9-433f-8258-a6e2a962674a 52763-501 HUMAN OTC DRUG LidoCream 5 Lidocaine CREAM TOPICAL 20140809 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g 52763-501_5b504885-5fdb-4b56-918e-8ce27ce62564 52763-501 HUMAN OTC DRUG LidoCream 5 Lidocaine CREAM TOPICAL 20101201 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g 52763-501_628bbf44-ae0b-4b86-b5f0-d616a30f8b5a 52763-501 HUMAN OTC DRUG LidoCream 5 Lidocaine CREAM TOPICAL 20101201 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g 52763-501_fd257b6b-6d31-4147-9433-5260562de6e3 52763-501 HUMAN OTC DRUG LidoCream 5 Lidocaine CREAM TOPICAL 20101201 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g 52763-502_4e6be424-1f1f-4439-8ab0-feaade688a46 52763-502 HUMAN OTC DRUG LidoCream 5 Lidocaine CREAM TOPICAL 20101201 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g 52763-504_2c669ca0-196c-4759-b9b1-fa677f14960e 52763-504 HUMAN OTC DRUG LidoCream 5 Lidocaine CREAM TOPICAL 20101201 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g 52763-600_288a5c6d-85b6-4579-a910-13fcc9bf86fc 52763-600 HUMAN OTC DRUG Simply Numb Endure Lidocaine CREAM TOPICAL 20140708 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g 52763-601_b18c4053-a0fd-4e37-a19b-bd0bfac4051d 52763-601 HUMAN OTC DRUG Simply Numb Endure Lidocaine CREAM TOPICAL 20140708 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g 52763-602_a0e5abf4-491b-409c-a115-852abda5a2a5 52763-602 HUMAN OTC DRUG Simply Numb Endure Lidocaine CREAM TOPICAL 20140708 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g 52763-604_1e8d586c-ee53-4a11-b4ce-0f08dc0b462f 52763-604 HUMAN OTC DRUG Simply Numb Endure Lidocaine CREAM TOPICAL 20140708 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g 52768-001_797bf74a-791d-429a-9c1e-c52b7390e416 52768-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F-18 Fludeoxyglucose F-18 INJECTION, SOLUTION INTRAVENOUS 20101010 UNAPPROVED DRUG OTHER Precision Nuclear LLC FLUDEOXYGLUCOSE F-18 500 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 52768-100_6732e16f-0ca4-4a47-8e23-c26da7741820 52768-100 HUMAN PRESCRIPTION DRUG AMMONIA N-13 AMMONIA N-13 INJECTION, SOLUTION INTRAVENOUS 20101010 UNAPPROVED DRUG OTHER Precision Nuclear LLC AMMONIA N-13 260 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 52768-125_850c575c-ecda-4b2b-b8db-9d1ff39499af 52768-125 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F-18 INJECTION INTRAVENOUS 20110101 UNAPPROVED DRUG OTHER Precision Nuclear LLC SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 52768-300_2f6d6994-701a-4025-92a1-597e914809aa 52768-300 HUMAN PRESCRIPTION DRUG Choline C 11 choline C 11 INJECTION INTRAVENOUS 20130607 UNAPPROVED DRUG OTHER Precision Nuclear LLC CHOLINE C-11 33.1 mCi/mL 52773-235_8702ad8f-d7a3-46b1-9b79-47db00d9793a 52773-235 HUMAN OTC DRUG Lorac Foundation Fair SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100mL; g/100mL; g/100mL 52773-236_e4cbcac3-d8eb-4bde-812a-9d0c006eecca 52773-236 HUMAN OTC DRUG Lorac Foundation Light SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100mL; g/100mL; g/100mL 52773-237_d2e1ae65-9d96-4358-ae98-de270188c8e4 52773-237 HUMAN OTC DRUG Lorac Foundation Light Beige SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100mL; g/100mL; g/100mL 52773-238_3e868859-dc32-4e1f-950b-7ae1cec84509 52773-238 HUMAN OTC DRUG Lorac Foundation Medium SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100mL; g/100mL; g/100mL 52773-239_0d021d34-fee9-4209-82ad-8315882a6724 52773-239 HUMAN OTC DRUG Lorac Foundation Golden Light SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100mL; g/100mL; g/100mL 52773-240_e5397b52-81ad-4771-b715-ed80bf8ca219 52773-240 HUMAN OTC DRUG Lorac Foundation Medium Beige SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100mL; g/100mL; g/100mL 52773-241_497b6f9a-eddd-46a7-a43b-0597ba62ecb7 52773-241 HUMAN OTC DRUG Lorac Foundation Medium Tan SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100mL; g/100mL; g/100mL 52773-242_6def3be7-70de-4c81-bc1b-136844732548 52773-242 HUMAN OTC DRUG Lorac Foundation Golden Tan SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100mL; g/100mL; g/100mL 52773-243_b76f3c77-22bd-46db-9913-947e1c70acff 52773-243 HUMAN OTC DRUG Lorac Foundation Tan SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100mL; g/100mL; g/100mL 52773-244_c662d055-71f6-425e-abfc-7bc807d6b94a 52773-244 HUMAN OTC DRUG Lorac Foundation Deep SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100mL; g/100mL; g/100mL 52793-700_83605e7c-39bf-9666-c6fd-23b5eeb14b5d 52793-700 HUMAN PRESCRIPTION DRUG Ahealon arnica montana, calendula officinalis flowering top, echinacea angustifolia, st. johns wort, silver, sulfur, allylthiourea and urtica urens SPRAY TOPICAL 20120409 UNAPPROVED HOMEOPATHIC PRINCETON BIOTECHNOLOGY CORPORATION ALLYLTHIOUREA; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; SILVER; ST. JOHN'S WORT; SULFUR; URTICA URENS 30; 30; 30; 30; 30; 30; 30; 30 {kp_C}/60mL; {kp_C}/60mL; {kp_C}/60mL; {kp_C}/60mL; {kp_C}/60mL; {kp_C}/60mL; {kp_C}/60mL; {kp_C}/60mL 52796-172_b4287a6a-044c-47e3-b1dd-3571b22e50cb 52796-172 HUMAN PRESCRIPTION DRUG Floriva CHOLECALCIFEROL and SODIUM FLUORIDE LIQUID ORAL 20141015 UNAPPROVED DRUG OTHER BonGeo Pharmaceuticals, Inc. CHOLECALCIFEROL; SODIUM FLUORIDE 400; .25 [iU]/mL; mg/mL Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 52796-174_203442ba-e9e8-44f3-931e-07edbe1ea690 52796-174 HUMAN PRESCRIPTION DRUG Floriva VITAMIN A ACETATE, .BETA.-CAROTENE, Ascorbic acid, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, and SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20141015 UNAPPROVED DRUG OTHER BonGeo Pharmaceuticals, Inc. .ALPHA.-TOCOPHEROL; .BETA.-CAROTENE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FOLIC ACID; LEVOMEFOLATE GLUCOSAMINE; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE; VITAMIN A ACETATE; ZINC GLUCONATE 20; 1000; 75; 40; 600; 1; 6; 100; 162; 15; 1.8; 1.5; .5; 1.3; 1000; 5 [iU]/1; [iU]/1; mg/1; ug/1; [iU]/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 52796-177_f3be912b-c8f7-42eb-8c12-b6aa672a1eeb 52796-177 HUMAN PRESCRIPTION DRUG Floriva VITAMIN A ACETATE, .BETA.-CAROTENE, Ascorbic acid, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, and SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20141015 UNAPPROVED DRUG OTHER BonGeo Pharmaceuticals, Inc. .ALPHA.-TOCOPHEROL; .BETA.-CAROTENE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FOLIC ACID; LEVOMEFOLATE GLUCOSAMINE; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE; VITAMIN A ACETATE; ZINC GLUCONATE 20; 1000; 75; 40; 600; 1; 6; 100; 162; 15; 1.8; 1.5; 1; 1.3; 1000; 5 [iU]/1; [iU]/1; mg/1; ug/1; [iU]/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 52797-010_846213cb-4b24-4eab-8aff-9a2f8180113c 52797-010 HUMAN OTC DRUG ATOTOP INTENSIVE MOISTURE ESSENCE WITCH HAZEL CREAM CUTANEOUS 20100901 OTC MONOGRAPH FINAL part347 MEDIWAY KOREA CO., LTD. WITCH HAZEL .05 mL/50mL 52797-020_a02ebf87-4daa-4c13-a3cf-0d826af3758f 52797-020 HUMAN OTC DRUG ACPURIS INTENSIVE SPOT TREATMENT SALICYLIC ACID CREAM CUTANEOUS 20100901 OTC MONOGRAPH FINAL part333D MEDIWAY KOREA CO., LTD. SALICYLIC ACID .3 mL/15mL 52797-030_2b9c8ea3-8ad6-48e3-a3f4-7d3123405c95 52797-030 HUMAN OTC DRUG Folli Pilose Revitalizing Follicle WITCH HAZEL SPRAY CUTANEOUS 20100901 OTC MONOGRAPH FINAL part347 MEDIWAY KOREA CO., LTD. WITCH HAZEL .15 mL/150mL 52810-102_c0193c3c-a061-4540-a114-130d4f66ab78 52810-102 HUMAN OTC DRUG ACNE FREE ECHINACEA ANGUSTIFOLIA, CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, MAHONIA AQUIFOLIUM FRUITING TOP SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; MAHONIA AQUIFOLIUM FRUITING TOP; SAMBUCUS NIGRA FLOWER 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-201_53e8a48b-22a6-4221-a7cb-085474067228 52810-201 HUMAN OTC DRUG BABY SKIN PINE NEEDLE OIL (PINUS SYLVESTRIS) SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER ECHINACEA ANGUSTIFOLIA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; PINE NEEDLE OIL (PINUS SYLVESTRIS); SAMBUCUS NIGRA FLOWER 3; 6; 2; 3 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-202_a4df9453-d1b0-4c21-9899-478655130e6c 52810-202 HUMAN OTC DRUG FIRST AID SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER PINE NEEDLE OIL (PINUS SYLVESTRIS) SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; PINE NEEDLE OIL (PINUS SYLVESTRIS); SAMBUCUS NIGRA FLOWER 2; 1; 2 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-203_e11f73c3-dbbb-42d4-9683-dad400bcd6df 52810-203 HUMAN OTC DRUG ORIGINAL HEALING PINE NEEDLE OIL (PINUS SYLVESTRIS) SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER ECHINACEA ANGUSTIFOLIA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; PINE NEEDLE OIL (PINUS SYLVESTRIS); SAMBUCUS NIGRA FLOWER 2; 2; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-204_6b82c28c-d685-4a17-90bf-8048a67d9fde 52810-204 HUMAN OTC DRUG INTENSIVE SKIN REPAIR SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER PINUS LAMBERTIANA RESIN ABIES BALSAMEA LEAF OIL SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY ABIES BALSAMEA LEAF OIL; CALENDULA OFFICINALIS FLOWER; PINUS LAMBERTIANA RESIN; SAMBUCUS NIGRA FLOWER 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-205_fdcc4428-83bd-4a8b-affd-25e6c9fe667e 52810-205 HUMAN OTC DRUG VETERNIARY FIRST AID SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER PINE NEEDLE OIL (PINUS SYLVESTRIS) SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; PINE NEEDLE OIL (PINUS SYLVESTRIS); SAMBUCUS NIGRA FLOWER 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-206_31413d34-770f-4320-9ec3-e33e02873dcf 52810-206 HUMAN OTC DRUG SKIN TAG RELIEF CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, ECHINACEA ANGUSTIFOLIA, THUJA OCCIDENTALIS SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; SAMBUCUS NIGRA FLOWER; THUJA OCCIDENTALIS LEAF 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-212_cb1a283f-ff2e-4cdf-b4b4-a1e3d9cc131a 52810-212 HUMAN OTC DRUG FIRST AID SAMBUCUS NIGRA FLOWER, CALENDULA OFFICINALIS FLOWER, ECHINACEA ANGUSTIFOLIA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; SAMBUCUS NIGRA FLOWER 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-213_798ba81d-1518-4ecf-ba58-45b209770b6b 52810-213 HUMAN OTC DRUG ORIGINAL HEALING SAMBUCUS NIGRA FLOWER, CALENDULA OFFICINALIS FLOWER, ECHINACEA ANGUSTIFOLIA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; SAMBUCUS NIGRA FLOWER 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-214_a658516f-4785-4429-aaa5-5a83526162d7 52810-214 HUMAN OTC DRUG BABY ACNE CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; SAMBUCUS NIGRA FLOWER; THUJA OCCIDENTALIS LEAF 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-217_56ea002f-2fe4-41c1-a7f6-2b3fddc8eb33 52810-217 HUMAN OTC DRUG BABY ECZEMA RELIEF CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; SAMBUCUS NIGRA FLOWER 1; 1 [hp_X]/100mL; [hp_X]/100mL 52810-301_02dd4fbd-46d1-404c-97b7-76ff3b1a37a0 52810-301 HUMAN OTC DRUG COLD SORE FREE SAMBUCUS NIGRA FLOWER ECHINACEA ANGUSTIFOLIA CALENDULA OFFICINALIS FLOWER PINE NEEDLE OIL (PINUS SYLVESTRIS) THUJA OCCIDENTALIS ROOT SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; PINE NEEDLE OIL (PINUS SYLVESTRIS); SAMBUCUS NIGRA FLOWER; THUJA OCCIDENTALIS ROOT 1; 2; 1; 1; 6 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-401_382837c3-18c2-48f6-be3e-9253d6f4f8b2 52810-401 HUMAN OTC DRUG ECZEMA AND PSORIASIS FREE PINE NEEDLE OIL (PINUS SYLVESTRIS) SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER MAHONIA AQUIFOLIUM ROOT BARK ECHINACEA ANGUSTIFOLIA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; MAHONIA AQUIFOLIUM ROOT BARK; PINE NEEDLE OIL (PINUS SYLVESTRIS); SAMBUCUS NIGRA FLOWER 2; 6; 3; 1; 2 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-402_8435efd9-76f6-4b28-9ccf-75c022517794 52810-402 HUMAN OTC DRUG SHINGLES RELIEF CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, ECHINACEA ANGUSTIFOLIA, THUJA OCCIDENTALIS, ARNICA MONTANA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY ARNICA MONTANA; CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; SAMBUCUS NIGRA FLOWER; THUJA OCCIDENTALIS LEAF 1; 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-411_50c718b5-9aea-4cf5-918d-31a174540ca5 52810-411 HUMAN OTC DRUG ECZEMA AND PSORIASIS FREE SAMBUCUS NIGRA FLOWER, CALENDULA OFFICINALIS FLOWER, ECHINACEA ANGUSTIFOLIA, BERBERIS VULGARIS WHOLE SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY BERBERIS VULGARIS WHOLE; CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; SAMBUCUS NIGRA FLOWER 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-501_c5ae2154-876f-4954-a677-765ac83a154c 52810-501 HUMAN OTC DRUG FUNGUS FREE PINE NEEDLE OIL (PINUS SYLVESTRIS) SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER THUJA OCCIDENTALIS LEAFY TWIG SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; PINE NEEDLE OIL (PINUS SYLVESTRIS); SAMBUCUS NIGRA FLOWER; THUJA OCCIDENTALIS LEAFY TWIG 2; 1; 2; 3 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-511_5516bc0d-7625-4412-be44-fea2b5351457 52810-511 HUMAN OTC DRUG FUNGUS FREE SAMBUCUS NIGRA FLOWER, CALENDULA OFFICINALIS FLOWER, THUJA OCCIDENTALIS LEAFY TWIG, ECHINACEA ANGUSTIFOLIA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; SAMBUCUS NIGRA FLOWER; THUJA OCCIDENTALIS LEAFY TWIG 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-602_3ffc96f4-7f30-455e-8c28-aa8f8ece553d 52810-602 HUMAN OTC DRUG ROSACEA FREE PINE NEEDLE OIL (PINUS SYLVESTRIS) SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER ABIES BALSAMEA LEAF OIL ECHINACEA ANGUSTIFOLIA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY ABIES BALSAMEA LEAF OIL; CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; PINE NEEDLE OIL (PINUS SYLVESTRIS); SAMBUCUS NIGRA FLOWER 2; 2; 6; 1; 2 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-701_7ace3124-bb2c-42e3-98ff-92d9e0803cb0 52810-701 HUMAN OTC DRUG WART FREE SAMBUCUS NIGRA FLOWER ECHINACEA ANGUSTIFOLIA CALENDULA OFFICINALIS FLOWER PINE NEEDLE OIL (PINUS SYLVESTRIS) THUJA OCCIDENTALIS WHOLE SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; PINE NEEDLE OIL (PINUS SYLVESTRIS); SAMBUCUS NIGRA FLOWER; THUJA OCCIDENTALIS WHOLE 1; 2; 1; 1; 6 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-702_8f5e4048-5262-457b-a72e-d959271d1849 52810-702 HUMAN OTC DRUG POISON OAK AND IVY RELIEF CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, ECHINACEA ANGUSTIFOLIA, ARNICA MONTANA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY ARNICA MONTANA; CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; SAMBUCUS NIGRA FLOWER 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-703_2a4108a1-203a-4d3c-877a-59494c1ae555 52810-703 HUMAN OTC DRUG SORE MUSCLE AND JOINT PAIN RELIEF ARNICA MONTANA AND HYPERICUM PERFORATUM CREAM TOPICAL 20131017 UNAPPROVED HOMEOPATHIC PUREMEDY ARNICA MONTANA; HYPERICUM PERFORATUM 1; 1 [hp_X]/100mL; [hp_X]/100mL 52810-801_6af540c6-4628-456e-bfab-33377d3622ac 52810-801 HUMAN OTC DRUG PERSONAL LUBRICANT SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER PINE NEEDLE OIL (PINUS SYLVESTRIS) SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY BERBERIS VULGARIS FRUIT; CALENDULA OFFICINALIS FLOWER; PINE NEEDLE OIL (PINUS SYLVESTRIS); SAMBUCUS NIGRA FLOWER 3; 2; 2; 2 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52810-802_1e29c70a-d032-4ee6-9716-8c21779ab767 52810-802 HUMAN OTC DRUG HEMORRHOID RELIEF CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, ECHINACEA ANGUSTIFOLIA, THUJA OCCIDENTALIS SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; SAMBUCUS NIGRA FLOWER; THUJA OCCIDENTALIS LEAF 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 52815-001_a1abc266-6ced-4d6b-abf6-e8284b6ea312 52815-001 HUMAN OTC DRUG SoCalm External Analgesic Methyl Salicylate PATCH TOPICAL 20101231 OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10 mg/100mg 52815-121_6cbed70a-5c2a-4615-8513-b9f545cb7d41 52815-121 HUMAN OTC DRUG soCALM Pain Relieving METHYL SALICYLATE PATCH TOPICAL 20110822 OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10 g/100g 52815-121_be3d78ca-ebef-4cb6-ba67-000abb6f6831 52815-121 HUMAN OTC DRUG soCALM Pain Relieving METHYL SALICYLATE PATCH TOPICAL 20110824 OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10 g/100g 52815-121_cad9d558-b16d-40c1-a782-3500b934d7c7 52815-121 HUMAN OTC DRUG soCALM Pain Relieving METHYL SALICYLATE PATCH TOPICAL 20110824 OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10 g/100g 52815-122_1c87a85f-e58b-4e5f-80f4-d5cc2851a0a6 52815-122 HUMAN OTC DRUG soCALM Pain Relieving METHYL SALICYLATE PATCH TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10 g/100g 52815-122_d1c77449-a29c-410c-a8a4-fe267a4fe802 52815-122 HUMAN OTC DRUG soCALM Pain Relieving METHYL SALICYLATE PATCH TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10 g/100g 52815-122_e3f0f3b1-b849-4a32-ada9-791e69f02523 52815-122 HUMAN OTC DRUG soCALM Pain Relieving METHYL SALICYLATE PATCH TOPICAL 20110824 OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10 g/100g 52815-123_669d3389-ed4d-4308-a766-20c7c21e5550 52815-123 HUMAN OTC DRUG soCALM Pain Relieving METHYL SALICYLATE PATCH TOPICAL 20110824 OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10 g/100g 52815-123_7ad4bf30-a421-4535-8635-1ae99898e353 52815-123 HUMAN OTC DRUG soCALM Pain Relieving METHYL SALICYLATE PATCH TOPICAL 20110824 OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10 g/100g 52815-123_87b343fc-6445-489c-82dd-6cd194ce7a1f 52815-123 HUMAN OTC DRUG soCALM Pain Relieving METHYL SALICYLATE PATCH TOPICAL 20110824 OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10 g/100g 52815-124_3c3d0bf4-ca13-489d-bbb2-0d7f05834c63 52815-124 HUMAN OTC DRUG soCALM Pain Relieving METHYL SALICYLATE PATCH TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10 g/100g 52815-124_aa5f5e77-1b32-425e-af40-480ee32f27de 52815-124 HUMAN OTC DRUG soCALM Pain Relieving METHYL SALICYLATE PATCH TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10 g/100g 52815-124_c0f3b212-6c7d-4ad4-b98e-a997f6686668 52815-124 HUMAN OTC DRUG soCALM Pain Relieving METHYL SALICYLATE PATCH TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10 g/100g 52815-125_ab75d6db-dccc-4d60-bdad-1e6c91ab26be 52815-125 HUMAN OTC DRUG soCALM Pain Relieving METHYL SALICYLATE PATCH TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10 g/100g 52815-125_cc2219ad-b10c-4678-a3cc-65a8207a8c02 52815-125 HUMAN OTC DRUG soCALM Pain Relieving METHYL SALICYLATE PATCH TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10 g/100g 52815-125_dde9d43a-6026-4dd9-8e2e-6f7c1d9e4362 52815-125 HUMAN OTC DRUG soCALM Pain Relieving METHYL SALICYLATE PATCH TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part348 AB7 Industries METHYL SALICYLATE 10 g/100g 52841-010_71aa7a87-ca1f-4b24-9813-921176f5a9a3 52841-010 HUMAN OTC DRUG PHYLLIS GOLDEN HAIR OATMEAL SHAMPOO CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 UNOCOS CO., LTD. OATMEAL .004 mL/400mL 52841-020_7c05a4e5-c3c0-4c3b-a38c-ab1c19fde097 52841-020 HUMAN OTC DRUG PHYLLIS GOLDEN HAIR ESSENCE OATMEAL SOLUTION CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 UNOCOS CO., LTD. OATMEAL .0008 mL/80mL 52849-100_bf78c990-e6cf-4601-af71-97b85aba22ff 52849-100 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19520101 UNAPPROVED MEDICAL GAS Capweld Inc OXYGEN 99 L/100L 52849-200_d9f4b162-4a2b-46ad-9024-8a9a3ebafd8c 52849-200 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19520101 UNAPPROVED MEDICAL GAS Capweld Inc NITROGEN 99 L/100L 52849-500_b961abb3-5d3a-4aee-a871-d4fb2a901101 52849-500 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19520101 UNAPPROVED MEDICAL GAS Capweld Inc NITROUS OXIDE 99 L/100L 52854-015_d5b121af-1571-45ec-bc08-3d925ecc3265 52854-015 HUMAN OTC DRUG Reef Safe SPF 15 octinoxate,octisalate, and oxybenzone LOTION TOPICAL 19950101 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL 52854-016_66f87097-918f-4ef3-a3d2-0d0c78319816 52854-016 HUMAN OTC DRUG Reef Safe SPF 15 homosalate, octinoxate, oxybenzone and octisalate SPRAY TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 10; 4; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL 52854-030_9dfc358e-715a-4a2b-ba21-890fdff1d6ad 52854-030 HUMAN OTC DRUG Reef Safe SPF 30 octinoxate,octisalate, and oxybenzone LOTION TOPICAL 19950101 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 4 g/100mL; g/100mL; g/100mL 52854-031_55ac1f98-23ee-4d9b-b4a7-5d42f900bd8c 52854-031 HUMAN OTC DRUG Reef Safe SPF 30 homosalate, octocrylene, octinoxate, oxybenzone and octisalate SPRAY TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 10; 6; 2; 6 g/100mL; g/100mL; g/100mL; g/100mL 52854-032_6eb069b9-4250-4424-be52-e041f0fb0707 52854-032 HUMAN OTC DRUG Reef Safe SPF 30 homosalate, octinoxate, oxybenzone and octisalate SPRAY TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 10; 6; 2; 6 g/100mL; g/100mL; g/100mL; g/100mL 52854-036_3348b2be-857a-4f7c-bc90-764fe6e92fbc 52854-036 HUMAN OTC DRUG Reef Safe SPF 36 octinoxate, oxybenzone, octisalate, and homosalate LOTION TOPICAL 19950101 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 4; 7.5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL 52854-045_1c492a85-2570-4316-839f-99a73041f003 52854-045 HUMAN OTC DRUG Reef Safe SPF 45 octocrylene, octinoxate, oxybenzone, homosalate and octisalate LOTION TOPICAL 19950101 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 5; 7.5; 5; 8; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 52854-046_880c7abd-d9f7-46bf-9fcf-87d06c71897c 52854-046 HUMAN OTC DRUG Reef Safe SPF 45 homosalate, octocrylene, octinoxate, oxybenzone and octisalate SPRAY TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 10; 7.5; 5; 10; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 52854-200_eeb9ba0f-b2e8-44ce-a5c6-99b396fe100f 52854-200 HUMAN OTC DRUG Reef Safe SPF 20 octocrylene, octisalate, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 1; 2; 3 g/100mL; g/100mL; g/100mL 52854-220_678f6456-f28c-4459-8bb9-666f67eb1e58 52854-220 HUMAN OTC DRUG Native Tan SPF 20 octocrylene, octisalate, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 1; 2; 3 g/100mL; g/100mL; g/100mL 52854-230_535f64f5-156d-4fb0-b8f1-e21aba640768 52854-230 HUMAN OTC DRUG Native Tan SPF 30 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.25; 2.5; 3; 2.5 g/100mL; g/100mL; g/100mL; g/100mL 52854-240_c5d3cbe3-9079-469c-8962-f2c3cb29dd4e 52854-240 HUMAN OTC DRUG Native Tan SPF 40 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 3; 3.5; 3 g/100mL; g/100mL; g/100mL; g/100mL 52854-250_c5a9eb11-593c-4144-bf84-149ada1775e7 52854-250 HUMAN OTC DRUG Native Tan SPF 50 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL 52854-255_090d32ee-353f-4bae-bcaf-66bd7851795d 52854-255 HUMAN OTC DRUG Native Tan SPF 50 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL 52854-300_bab95c4a-b207-4367-99ae-1934f81553b0 52854-300 HUMAN OTC DRUG Reef Safe SPF 30 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.25; 2.5; 3; 2.5 g/100mL; g/100mL; g/100mL; g/100mL 52854-400_6ff9e7dd-afe2-40b5-9b41-ec363b621142 52854-400 HUMAN OTC DRUG Reef Safe SPF 40 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 3; 3.5; 3 g/100mL; g/100mL; g/100mL; g/100mL 52854-500_74ff963a-353e-4926-8e74-5940992bb488 52854-500 HUMAN OTC DRUG Reef Safe SPF 50 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL 52854-530_ef5877b0-e881-4e12-8c2c-dffd06c6e994 52854-530 HUMAN OTC DRUG Reef Kids SPF 30 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.25; 2.5; 3; 2.5 g/100mL; g/100mL; g/100mL; g/100mL 52854-531_43d91b72-bf11-4f04-b276-59bb53e415da 52854-531 HUMAN OTC DRUG Reef Kids SPF 30 homosalate, octinoxate, oxybenzone and octisalate SPRAY TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 10; 6; 2; 6 g/100mL; g/100mL; g/100mL; g/100mL 52854-540_840ebf64-c006-4623-bf2d-5aff0c7aa6be 52854-540 HUMAN OTC DRUG Reef Kids SPF 40 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 3; 3.5; 3 g/100mL; g/100mL; g/100mL; g/100mL 52854-550_6ff59f79-4c09-463c-801f-12fdd77938dc 52854-550 HUMAN OTC DRUG Reef Babies SPF 50 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL 52862-001_c224c94a-a633-4bb1-ada1-81a05617adde 52862-001 HUMAN OTC DRUG Petroleum WHITE PETROLEUM JELLY TOPICAL 20101020 OTC MONOGRAPH FINAL part347 International Wholesale Inc. PETROLATUM 100 g/100g 52862-002_ec708a9d-23b9-44ab-b68f-5be183897c1d 52862-002 HUMAN OTC DRUG Petroleum Jelly Aloe Vera Scent WHITE PETROLEUM JELLY TOPICAL 20101021 OTC MONOGRAPH FINAL part347 International Wholesale Inc. PETROLATUM 99.9 g/100g 52862-003_cceca6d2-02e8-4e5d-b1fc-aa57441978c0 52862-003 HUMAN OTC DRUG Petroleum Jelly Fresh Scent WHITE PETROLEUM JELLY TOPICAL 20101021 OTC MONOGRAPH FINAL part347 International Wholesale Inc. PETROLATUM 99.9 g/100g 52862-004_f88fefdd-77e7-419f-b7ac-6254ab0e364c 52862-004 HUMAN OTC DRUG Petroleum Jelly Cocoa Butter Scent WHITE PETROLEUM JELLY TOPICAL 20101021 OTC MONOGRAPH FINAL part347 International Wholesale Inc. PETROLATUM 99.9 g/100g 52862-005_8e92bc2b-61df-4a51-9ed2-83fd838fb28a 52862-005 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part333A Home Smart Products ISOPROPYL ALCOHOL 50 mL/100mL 52862-006_795f5942-d8e3-4108-b143-f263142742c7 52862-006 HUMAN OTC DRUG Isopropyl Rubbing Alcohol With Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part333A Home Smart Products ISOPROPYL ALCOHOL 50 mL/100mL 52862-007_a66cce04-9926-48b4-9ff5-5af28b3cc754 52862-007 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20120708 OTC MONOGRAPH NOT FINAL part333A Home Smart Products HYDROGEN PEROXIDE 3 mL/100mL 52862-008_249575b6-5b73-46f5-a9a5-a981345a2feb 52862-008 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120722 OTC MONOGRAPH FINAL part333A Home Smart Products ISOPROPYL ALCOHOL 70 mL/100mL 52862-009_f4259d56-3049-4ee8-a6ca-c97aceee5c16 52862-009 HUMAN OTC DRUG Isopropyl Rubbing Alcohol With Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20120722 OTC MONOGRAPH FINAL part333A Home Smart Products ISOPROPYL ALCOHOL 70 mL/100mL 52862-010_aa30f062-3187-456e-bb83-fe75d0d4f969 52862-010 HUMAN OTC DRUG Health Smart Baby TALC POWDER TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part347 Home Smart Products TALC 1 g/g 52862-011_a8ec41f8-3182-4bb3-bc1a-b50818a3a26e 52862-011 HUMAN OTC DRUG Health Smart Lavender Baby Petroleum White Petroleum JELLY TOPICAL 20130728 OTC MONOGRAPH FINAL part347 Home Smart Products PETROLATUM 99.9 g/100g 52862-012_1f20e3e7-3270-4dee-a979-bf7b55a78779 52862-012 HUMAN OTC DRUG Health Smart Aloe Vera Petroleum White Petroleum JELLY TOPICAL 20130728 OTC MONOGRAPH FINAL part347 Home Smart Products PETROLATUM 99.9 g/100g 52862-013_92331876-9f76-4765-8920-9ca2998502e5 52862-013 HUMAN OTC DRUG Health Smart Original Petroleum White Petroleum JELLY TOPICAL 20130728 OTC MONOGRAPH FINAL part347 Home Smart Products PETROLATUM 100 g/100g 52862-014_8e45063b-d099-40f2-be28-1df7175ddde8 52862-014 HUMAN OTC DRUG Health Smart Cocoa Butter Petroleum White Petroleum JELLY TOPICAL 20130728 OTC MONOGRAPH FINAL part347 Home Smart Products PETROLATUM 99.9 g/100g 52862-015_8a81d8ac-d5cf-40b1-a5bc-101b4d6a8638 52862-015 HUMAN OTC DRUG Health Smart Baby Petroleum White Petroleum JELLY TOPICAL 20130728 OTC MONOGRAPH FINAL part347 Home Smart Products PETROLATUM 99.9 g/100g 52862-016_79ff63a3-1e94-4a62-888a-c3d3276c9d26 52862-016 HUMAN OTC DRUG Health Smart Vaporizing Chest Rub Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part348 Home Smart Products CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.7; 1; 1 g/100g; g/100g; g/100g 52862-017_54a6a677-7241-49f9-b5a7-999a3697b9e5 52862-017 HUMAN OTC DRUG Health Smart Blue Ice Topical Analgesic Menthol and Camphor GEL TOPICAL 20131002 OTC MONOGRAPH NOT FINAL part348 Home Smart Products CAMPHOR (SYNTHETIC); MENTHOL .5; 1 g/100g; g/100g 52862-018_1f02a972-550e-408e-85ea-0f84fc7c416e 52862-018 HUMAN OTC DRUG Health Smart Creamy Petroleum Petroleum JELLY TOPICAL 20140110 OTC MONOGRAPH FINAL part347 International Wholesale Inc dba Home Smart Products PETROLATUM 30 g/100g 52862-019_53ecf499-f0e3-4870-9afd-5c4ece2ed428 52862-019 HUMAN OTC DRUG Health Smart Creamy Cocoa Butter Petroleum Petroleum JELLY TOPICAL 20140110 OTC MONOGRAPH FINAL part347 International Wholesale Inc dba Home Smart Products PETROLATUM 30 g/100g 52862-020_ff69a3d2-ffad-4153-be70-eb07f59b7272 52862-020 HUMAN OTC DRUG Health Smart Medicated Body Menthol and Zinc Oxide POWDER TOPICAL 20140227 OTC MONOGRAPH NOT FINAL part348 International Wholesale Inc dba Home Smart Products MENTHOL; ZINC OXIDE .15; 1 g/100g; g/100g 52862-021_30492149-ec96-4b96-9691-6e353fe10fde 52862-021 HUMAN OTC DRUG Health Smart Medicated Foot Menthol POWDER TOPICAL 20140227 OTC MONOGRAPH NOT FINAL part348 International Wholesale Inc dba Home Smart Products MENTHOL 1 g/100g 52862-100_16600f71-1758-4a81-9419-d67d39cae862 52862-100 HUMAN OTC DRUG Health Smart Antibacterial Wet Wipes BENZETHONIUM CHLORIDE SWAB TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333A International Wholesale, Inc. BENZETHONIUM CHLORIDE .3 g/1001 52862-200_c74ab8c0-23e2-457e-a5aa-a2d4dcc7e20e 52862-200 HUMAN OTC DRUG Health Smart Natural Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL 20130801 OTC MONOGRAPH NOT FINAL part334 International Wholesale, Inc. MAGNESIUM SULFATE 1 g/g 52862-201_42e0ae69-2760-4e6e-b8b8-2da52c319e40 52862-201 HUMAN OTC DRUG Health Smart Natural Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL 20130801 OTC MONOGRAPH NOT FINAL part334 International Wholesale, Inc. MAGNESIUM SULFATE 1 g/g 52862-301_b9732780-c182-4e2c-bfde-e152e0044741 52862-301 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e cucumber melon ALCOHOL SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 65 mL/100mL 52862-302_172d18de-2122-42fc-9c3e-6909510b438e 52862-302 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e sweet pea ALCOHOL SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 65 mL/100mL 52862-303_43608b20-10e0-433c-8c45-30d9ed1ad2ad 52862-303 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e lavender ALCOHOL SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 65 mL/100mL 52862-304_a9706aea-03c7-47c3-94b0-411f59668830 52862-304 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e peach ALCOHOL SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 65 mL/100mL 52862-306_1633e875-5413-4f6e-a66f-d73ccb431bea 52862-306 HUMAN OTC DRUG Health Smart Antibacterial original TRICLOSAN SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. TRICLOSAN .15 mg/100mL 52862-307_98266fdd-aa9a-46c7-b3d2-16721a050faa 52862-307 HUMAN OTC DRUG Health Smart Antibacterial cucumber melon TRICLOSAN SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. TRICLOSAN .15 mg/100mL 52862-308_5f5b8ba9-f593-4ab3-9ef3-3ad2cbab910e 52862-308 HUMAN OTC DRUG Health Smart Antibacterial sweet pea orchid TRICLOSAN SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. TRICLOSAN .15 mg/100mL 52862-309_9c7b268b-018b-4a11-843b-aa43884aee3b 52862-309 HUMAN OTC DRUG Health Smart Antibacterial lavender chamomile TRICLOSAN SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. TRICLOSAN .15 mg/100mL 52862-310_d684cc32-257c-4b04-b66c-43e3c2fe93a9 52862-310 HUMAN OTC DRUG Health Smart Antibacterial Spring Rain TRICLOSAN SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. TRICLOSAN .15 mg/100mL 52862-313_0dea23f8-c7bc-4cb6-be93-2956036033e2 52862-313 HUMAN OTC DRUG ANTIBACTERIAL BANDAGE benzalkonium chloride SWAB TOPICAL 20140923 OTC MONOGRAPH NOT FINAL part333A International Wholesale, Inc. BENZALKONIUM CHLORIDE 1 g/100g 52862-314_f5e3ded5-f134-4f2c-b725-1b0adae744aa 52862-314 HUMAN OTC DRUG Total Comfort Fresh Blast aluminum chlorhydrate STICK TOPICAL 20140928 OTC MONOGRAPH FINAL part350 International Wholesale, Inc. ALUMINUM CHLOROHYDRATE 11.4 g/57g 52862-315_8722b55b-21bd-46fb-85c5-f14e97de4fef 52862-315 HUMAN OTC DRUG Total Comfort Cool Blast aluminum chlorhydrate STICK TOPICAL 20140928 OTC MONOGRAPH FINAL part350 International Wholesale, Inc. ALUMINUM CHLOROHYDRATE 11.4 g/57g 52862-401_084413d5-d20c-12d8-e054-00144ff88e88 52862-401 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e cucumber melon ALCOHOL SOLUTION TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 62 mL/100mL 52862-402_084413d5-d21a-12d8-e054-00144ff88e88 52862-402 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e sweet pea ALCOHOL SOLUTION TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 62 mL/100mL 52862-403_084413d5-d228-12d8-e054-00144ff88e88 52862-403 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e lavender ALCOHOL SOLUTION TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 62 mL/100mL 52862-404_084413d5-d236-12d8-e054-00144ff88e88 52862-404 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e peach ALCOHOL SOLUTION TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 62 mL/100mL 52862-405_084413d5-d244-12d8-e054-00144ff88e88 52862-405 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e ALCOHOL SOLUTION TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 62 mL/100mL 52862-412_da30dd47-f183-4f3c-9f01-ba57d2006b5c 52862-412 HUMAN OTC DRUG 3 HAND SANITIZERS ALCOHOL KIT TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part333A International Wholesale, Inc. 52891-100_9960d2bb-15e8-44e1-b3d0-15904fed11d3 52891-100 HUMAN OTC DRUG Dr. Oberon Moms Care Cream dimethicone CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 Oberon Cosmetic Co., Ltd. DIMETHICONE 1 g/100g 52891-101_45a35ea6-9af4-4375-b0fe-b36ed00a3a74 52891-101 HUMAN OTC DRUG Dr. OBERON MOMS CARE OIL dimethicone OIL TOPICAL 20140601 OTC MONOGRAPH FINAL part347 Oberon Cosmetic Co., Ltd. DIMETHICONE 1.5 1/150mL 52891-102_86aafc39-2b4a-4e6e-85ac-50c08dc248b7 52891-102 HUMAN OTC DRUG Dr. OBERON MOMS CARE BODY OIL dimethicone OIL TOPICAL 20140612 OTC MONOGRAPH FINAL part347 Oberon Cosmetic Co., Ltd. DIMETHICONE 26 1/100mL 52891-103_4fc9641a-9d0a-42fb-91de-eb735eb02127 52891-103 HUMAN OTC DRUG DR. OBERON NATURAL BABY allantoin LOTION TOPICAL 20140621 OTC MONOGRAPH FINAL part347 Oberon Cosmetic Co., Ltd. ALLANTOIN .5 1/50mL 52891-104_ed5b7c1e-1d1f-4633-870c-c87cf3f53c33 52891-104 HUMAN OTC DRUG Dr. Oberon Diaper Rash Baby Cream zinc oxide, dimethicone CREAM TOPICAL 20140626 OTC MONOGRAPH FINAL part347 Oberon Cosmetic Co., Ltd. DIMETHICONE; ZINC OXIDE .15; .75 g/15g; g/15g 52891-105_391b65e5-1212-4168-ab62-3a6c2be2b1f1 52891-105 HUMAN OTC DRUG Dr. Oberon Original Snail Cream dimethicone CREAM TOPICAL 20140627 OTC MONOGRAPH FINAL part347 Oberon Cosmetic Co., Ltd. DIMETHICONE 11.5 g/50g 52893-001_01e0d895-cc73-46b3-a9cd-14550957c5ca 52893-001 HUMAN OTC DRUG Pure Snow whitening Sodium Fluoride GEL, DENTIFRICE DENTAL 20121130 OTC MONOGRAPH FINAL part355 Itena Clinical SODIUM FLUORIDE .07 g/28.35g 52904-430_467fa578-bb0b-48dd-b5e2-36e5e9829c96 52904-430 HUMAN OTC DRUG Allergy Relief Non Drowsy Loratadine TABLET ORAL 20121015 ANDA ANDA077153 Select Corporation LORATADINE 10 mg/1 52904-443_5fb1e4e8-81a7-4644-ba6e-ab3197e045b3 52904-443 HUMAN OTC DRUG Stomach Relief Anti Diarrheal LOPERAMIDE HYDROCHLORIDE TABLET ORAL 20121015 ANDA ANDA074091 Select Corporation LOPERAMIDE HYDROCHLORIDE 2 mg/1 52904-445_d7246931-0404-4c47-826a-f9c448663116 52904-445 HUMAN OTC DRUG Pain Relief PM Nightime Sleep Aid Acetaminophen,Diphenhydramine HCl TABLET, COATED ORAL 20121015 OTC MONOGRAPH NOT FINAL part348 Select Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 52904-446_f7cedd09-39f0-4e3c-a6e6-d8b00da2075e 52904-446 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20121015 OTC MONOGRAPH NOT FINAL part343 Select Corporation ACETAMINOPHEN 500 mg/1 52904-447_9b05aa4c-903e-43ec-a79f-ec675bc6e77a 52904-447 HUMAN OTC DRUG Pain Relief IBUPROFEN TABLET ORAL 20121015 ANDA ANDA091239 Select Corporation IBUPROFEN 200 mg/1 52904-448_a3f26a2a-f404-4d48-bbae-0ee263ff409b 52904-448 HUMAN OTC DRUG Heartburn Relief FAMOTIDINE TABLET ORAL 20140314 ANDA ANDA077146 Select Corporation FAMOTIDINE 10 mg/1 52904-455_87b3e0da-482d-4cbb-aff7-6b147259e67a 52904-455 HUMAN OTC DRUG Sinus Relief Severe Congestion Acetaminophen,Guaifenesin, Phenylephrine HCl TABLET ORAL 20121015 OTC MONOGRAPH FINAL part341 Select Corporation ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 52904-456_54839955-9752-4d0c-8de8-051c3e1f40ef 52904-456 HUMAN OTC DRUG Cold Relief Severe Pain Cough Acetaminophen,Guaifenesin, Phenylephrine HCl, Dextromethorphan Hydrobromide TABLET ORAL 20121015 OTC MONOGRAPH FINAL part341 Select Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 52904-457_20ec419a-7112-4ba7-a0ec-da4dc0100e39 52904-457 HUMAN OTC DRUG Allergy Relief Multisymptom Acetaminophen,Chlorpheniramine Maleate, Phenylephrine HCl TABLET, COATED ORAL 20121015 OTC MONOGRAPH FINAL part341 Select Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 52904-460_249fe75a-9f9e-4e59-985b-b49fe3c3c60f 52904-460 HUMAN OTC DRUG Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20121015 OTC MONOGRAPH FINAL part341 Select Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 52904-468_f2f10382-7393-4c08-848a-6cbb96187e8a 52904-468 HUMAN OTC DRUG Pain Relief Maximum Strength Acetaminophen,Aspirin,Caffeine TABLET, COATED ORAL 20121015 OTC MONOGRAPH NOT FINAL part343 Select Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 52904-470_3e14dfb0-e890-4e1f-9d45-851240ce33db 52904-470 HUMAN OTC DRUG Allertness Aid Caffeine TABLET ORAL 20121015 OTC MONOGRAPH FINAL part340 Select Corporation CAFFEINE 200 mg/1 52904-486_5cfb8979-277a-418e-800e-11dd0c0ed783 52904-486 HUMAN OTC DRUG Pain Relief Anti inflammatory IBUPROFEN TABLET ORAL 20121015 ANDA ANDA091239 Select Corporation IBUPROFEN 200 mg/1 52904-493_ae5d9540-a988-4072-9a46-b2bfcb4fd3a1 52904-493 HUMAN OTC DRUG Sinus Relief Headache Nasal Acetaminophen,Phenylephrine HCl TABLET ORAL 20121015 OTC MONOGRAPH FINAL part341 Select Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 52915-010_9e852356-81c0-4373-b9f3-845a444c7a22 52915-010 HUMAN OTC DRUG ECZEMA OATMEAL LOTION/SHAMPOO TOPICAL 20121001 OTC MONOGRAPH FINAL part347 ORGANIC & SUSTAINABLE BEAUTY OATMEAL 10 mg/mL 52915-020_4c985748-88a3-4bcb-a8b8-5d9e44b64231 52915-020 HUMAN OTC DRUG SKIN PROTECTANT ALLANTOIN LOTION/SHAMPOO TOPICAL 20121001 OTC MONOGRAPH FINAL part347 ORGANIC & SUSTAINABLE BEAUTY ALLANTOIN 5.5 mg/mL 52915-030_fb9596eb-a43a-443f-a2d4-3cf53ddacad2 52915-030 HUMAN OTC DRUG SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN TITANIUM DIOXIDE LOTION/SHAMPOO TOPICAL 20100401 OTC MONOGRAPH FINAL part352 ORGANIC & SUSTAINABLE BEAUTY TITANIUM DIOXIDE 120 mg/g 52915-040_64c24fff-56a1-4038-8dcb-502fc21f4b43 52915-040 HUMAN OTC DRUG SPF30 SUMMER BLEND SUNSCREEN TITANIUM DIOXIDE LOTION/SHAMPOO TOPICAL 20100401 OTC MONOGRAPH FINAL part352 ORGANIC & SUSTAINABLE BEAUTY TITANIUM DIOXIDE 120 mg/g 52915-050_e767043a-0232-4ca9-9dbb-fc73f4d64ef6 52915-050 HUMAN OTC DRUG SPF30 SUPER SENSITIVE SUNSCREEN TITANIUM DIOXIDE LOTION/SHAMPOO TOPICAL 20100401 OTC MONOGRAPH FINAL part352 ORGANIC & SUSTAINABLE BEAUTY TITANIUM DIOXIDE 120 mg/g 52915-060_1bd5d262-c0d8-4653-9432-de3f0064612b 52915-060 HUMAN OTC DRUG SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN TITANIUM DIOXIDE STICK TOPICAL 20110401 OTC MONOGRAPH FINAL part352 ORGANIC & SUSTAINABLE BEAUTY TITANIUM DIOXIDE 170 mg/g 52915-070_069627d7-ecb8-4603-a1b0-95266b77aa73 52915-070 HUMAN OTC DRUG SPF30 SUPER SENSITIVE SUNSCREEN TITANIUM DIOXIDE STICK TOPICAL 20110401 OTC MONOGRAPH FINAL part352 ORGANIC & SUSTAINABLE BEAUTY TITANIUM DIOXIDE 170 mg/g 52915-080_12119a01-6f33-4911-b741-07c70f26fd73 52915-080 HUMAN OTC DRUG SPF 18 EVERYDAY/YEAR-ROUND SUNSCREEN TITANIUM DIOXIDE LOTION/SHAMPOO TOPICAL 20110301 OTC MONOGRAPH FINAL part352 ORGANIC & SUSTAINABLE BEAUTY TITANIUM DIOXIDE 80 mg/mL 52915-090_69693f1d-db08-45ff-a854-c017cb6c9277 52915-090 HUMAN OTC DRUG SPF 18 SUPER SENSITIVE SUNSCREEN TITANIUM DIOXIDE LOTION/SHAMPOO TOPICAL 20110501 OTC MONOGRAPH FINAL part352 ORGANIC & SUSTAINABLE BEAUTY TITANIUM DIOXIDE 80 mg/mL 52915-100_a7ecbe99-561b-41c9-94f4-962dd8ebbad9 52915-100 HUMAN OTC DRUG CALMING DIAPER RASH ZINC OXIDE CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part347 ORGANIC & SUSTAINABLE BEAUTY ZINC OXIDE 120 mg/g 52915-110_1a6117b6-84a4-4131-9073-6942dd15290d 52915-110 HUMAN OTC DRUG SUPER SENSITIVE DIAPER RASH ZINC OXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH FINAL part347 ORGANIC & SUSTAINABLE BEAUTY ZINC OXIDE 120 mg/g 52915-120_03bb0bc9-2b95-4dc9-84de-3196d2aad161 52915-120 HUMAN OTC DRUG ECZEMA OATMEAL CREAM TOPICAL 20121201 OTC MONOGRAPH FINAL part347 ORGANIC & SUSTAINABLE BEAUTY OATMEAL 10 mg/mL 52915-130_57972512-cb1a-4d9e-a535-7f4772835516 52915-130 HUMAN OTC DRUG SKIN PROTECTANT allantoin CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part347 ORGANIC & SUSTAINABLE BEAUTY ALLANTOIN 7.5 mg/mL 52919-116_10ba586a-ebec-44db-9f5f-4abf34b743b0 52919-116 HUMAN PRESCRIPTION DRUG Zeel ARNICA MONTANA and TOXICODENDRON PUBESCENS LEAF and SOLANUM DULCAMARA STEM and SYMPHYTUM TUBEROSUM ROOT and SULFUR and SANGUINARIA CANADENSIS ROOT and SUS SCROFA CARTILAGE and SUS SCROFA EMBRYO and SU INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110124 UNAPPROVED HOMEOPATHIC Hameln Pharma GmbH ALPHA LIPOIC ACID; ARNICA MONTANA; COENZYME A; NADIDE; SANGUINARIA CANADENSIS ROOT; SODIUM DIETHYL OXALACETATE; SOLANUM DULCAMARA STEM; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; SYMPHYTUM TUBEROSUM ROOT; TOXICODENDRON PUBESCENS LEAF 8; 4; 8; 8; 4; 8; 3; 6; 6; 6; 6; 6; 6; 2 [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL 52919-123_aea30801-f2e6-48e6-9724-21ad9201b441 52919-123 HUMAN PRESCRIPTION DRUG Lymphomyosot GERANIUM ROBERTIANUM and RORIPPA NASTURTIUM-AQUATICUM and TRIBASIC CALCIUM PHOSPHATE and LEVOTHYROXINE and INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100401 UNAPPROVED HOMEOPATHIC Hameln Pharma GmbH ARANEUS DIADEMATUS; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FLOWERING TOP; LEVOTHYROXINE; MYOSOTIS ARVENSIS; PINUS SYLVESTRIS TOP; RORIPPA NASTURTIUM-AQUATICUM; SARSAPARILLA; SCROPHULARIA NODOSA; SODIUM SULFATE; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 6; 4; 12; 4; 5; 4; 3; 12; 3; 4; 4; 6; 3; 4; 3; 12; 3 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52919-141_2f4d1e39-ed6a-4b39-ba5a-00e21ead2874 52919-141 HUMAN PRESCRIPTION DRUG Spascupreel ACONITUM NAPELLUS and AMMONIUM BROMIDE and CITRULLUS COLOCYNTHIS FRUIT PULP and ATROPINE SULFATE and GELSEMIUM SEMPERVIRENS ROOT and MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE and VERATRUM ALBUM ROOT and INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110120 UNAPPROVED HOMEOPATHIC Hameln Pharma GmbH ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA; AMMONIUM BROMIDE; ATROPINE SULFATE; CHAMOMILE; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC SULFATE; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PASSIFLORA INCARNATA FLOWER; VERATRUM ALBUM ROOT 6; 4; 4; 6; 3; 4; 6; 6; 6; 2; 6 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL 52919-161_64e7423c-a82b-4fd6-bc27-95dd3697a0cd 52919-161 HUMAN PRESCRIPTION DRUG Traumeel ARNICA MONTANA ROOT and ATROPA BELLADONNA and CALENDULA OFFICINALIS FLOWERING TOP and MATRICARIA RECUTITA and ACHILLEA MILLEFOLIUM and CALCIUM SULFIDE and COMFREY ROOT and ACONITUM NAPELLUS and BELLIS INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100401 UNAPPROVED HOMEOPATHIC Hameln Pharma GmbH ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA LEAF; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS 3; 2; 2; 2; 2; 6; 2; 6; 2; 2; 1; 2; 3; 6 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL 52920-121_41514997-ced8-4066-b3dd-0f34dab78e88 52920-121 HUMAN OTC DRUG Pure Petroleum White Petroleum JELLY TOPICAL 20100310 OTC MONOGRAPH FINAL part347 Singhfam Corporation PETROLATUM 1 g/g 52920-122_b692dfbf-9030-482a-9cc3-f66b9728b4e3 52920-122 HUMAN OTC DRUG Baby Petroleum White Petroleum JELLY TOPICAL 20101001 OTC MONOGRAPH FINAL part347 Singhfam Corporation PETROLATUM 1 g/g 52920-123_8464acae-c276-4b48-a40d-1b8bb4e46135 52920-123 HUMAN OTC DRUG Pain Relieving Analgesic Menthol GEL TOPICAL 20090921 OTC MONOGRAPH FINAL part341 Singhfam Corporation MENTHOL 4.54 g/g 52920-124_b027e33f-e5db-4d99-8f3a-4bf55fbce922 52920-124 HUMAN OTC DRUG Vaporizing Chest Rub Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20100310 OTC MONOGRAPH FINAL part341 Singhfam Corporation CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.7; 1.1; 1.1 g/113g; g/113g; g/113g 52920-125_20a1c1ec-3dee-4bbc-8b81-28962d04ade2 52920-125 HUMAN OTC DRUG Pure Petroleum Cocoa Butter Scented White Petroleum JELLY TOPICAL 20121001 OTC MONOGRAPH FINAL part347 Singhfam Corporation. PETROLATUM .99 g/g 52920-126_a4eb8b73-c171-4307-ad77-7f83afe8a90a 52920-126 HUMAN OTC DRUG Baby Petroleum White Petroleum JELLY TOPICAL 20101001 OTC MONOGRAPH FINAL part347 Singhfam Corporation PETROLATUM .99 g/g 52925-512_fe56207b-acf9-4ad9-b7c4-1da1112e9134 52925-512 HUMAN OTC DRUG VCF CONTRACEPTIVE PRE-FILLED APPLICATORS NONOXYNOL-9 GEL, METERED VAGINAL 20140601 OTC MONOGRAPH NOT FINAL part333A APOTHECUS PHARMACEUTICAL CORP NONOXYNOL-9 4 g/100g 52936-170_2b44379a-62ef-4d0a-a2f2-964c09d590cc 52936-170 HUMAN OTC DRUG PARAID Alcohol ISOPROPYL ALCOHOL LIQUID TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part333A Planet (Shanghai) International Co., Ltd. ISOPROPYL ALCOHOL 70 g/100g 52937-001_3fd8c6ea-8d54-4b13-9d8c-0fa9cf0730ed 52937-001 HUMAN PRESCRIPTION DRUG Vascepa icosapent ethyl CAPSULE ORAL 20121001 NDA NDA202057 Amarin Pharma Inc. ICOSAPENT ETHYL 1000 mg/1 52937-101_3fd8c6ea-8d54-4b13-9d8c-0fa9cf0730ed 52937-101 HUMAN PRESCRIPTION DRUG Vascepa icosapent ethyl CAPSULE ORAL 20121001 NDA NDA202057 Amarin Pharma Inc. ICOSAPENT ETHYL 1000 mg/1 52959-003_a2c3b08c-f9ce-4ff2-b26a-8aba341de515 52959-003 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 H.J. Harkins Company, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII 52959-008_a90b16ab-0c90-4e42-a281-7989f2158ebe 52959-008 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 H.J. Harkins Company, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 52959-009_8a441358-7fed-46d1-9401-ba50193cc639 52959-009 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 H.J. Harkins Company, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52959-011_28d573ee-7c75-40c4-ac13-125339ea9269 52959-011 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 H.J. Harkins Company, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 52959-014_2501c5c7-df08-4d3a-8ee6-6c28e3c985f9 52959-014 HUMAN OTC DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Neomycin and Polymyxin B Sulfates and Bacitracin Zinc OINTMENT TOPICAL 20100106 OTC MONOGRAPH FINAL part333B H.J. Harkins Company, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [USP'U]/g; mg/g; [USP'U]/g 52959-018_b761ebd8-e9bb-46d1-9671-8e59373f51f6 52959-018 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH FINAL part343 H.J. Harkins Company, Inc. ASPIRIN 325 mg/1 52959-020_28d573ee-7c75-40c4-ac13-125339ea9269 52959-020 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 H.J. Harkins Company, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 52959-026_8baadcf8-d2c4-40c6-9fa0-485a0d699745 52959-026 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19960124 ANDA ANDA040124 H.J. Harkins Company, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 52959-028_400e1d37-ae36-4c98-95fb-59732443853c 52959-028 HUMAN OTC DRUG Menthol and Methyl Salicylate Menthol and Methyl Salicylate STICK TOPICAL 19910601 OTC MONOGRAPH NOT FINAL part348 H.J. Harkins Company, Inc. MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g 52959-030_87894a01-9fab-4362-b6d4-f9a5f6a88d0f 52959-030 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051201 ANDA ANDA065229 H.J. Harkins Company, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52959-031_749fe83a-d77e-46c1-8f31-6f318af9a2da 52959-031 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060201 ANDA ANDA065215 H.J. Harkins Company, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52959-033_dda3a80a-8f5f-4502-ac2c-d4ac81fab9ce 52959-033 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride TABLET ORAL 20100604 ANDA ANDA040659 H.J. Harkins Company, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 52959-034_1d7bd683-a263-467b-ac59-22f200b04aef 52959-034 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100427 ANDA ANDA078938 H.J. Harkins Company, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 52959-041_7a471140-a07a-4ee7-926c-824f568ae061 52959-041 HUMAN OTC DRUG LiquiTears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20111209 OTC MONOGRAPH FINAL part349 H.J. Harkins Company, Inc. POLYVINYL ALCOHOL 14 mg/mL 52959-049_8ff3da59-a3a2-4b6b-9445-3e578afe500e 52959-049 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 20110120 ANDA ANDA062286 H.J. Harkins Company, Inc. DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 52959-053_dd6764ad-1dcd-457a-a31a-5fb041c83a7f 52959-053 HUMAN OTC DRUG Diphenhydramine Diphenhydramine Hydrochloride CAPSULE ORAL 20110817 OTC MONOGRAPH FINAL part348 H.J. Harkins Company, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 52959-054_bd1cea53-2311-499a-a9f0-8473ff0bdc14 52959-054 HUMAN OTC DRUG Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate OINTMENT TOPICAL 20100106 OTC MONOGRAPH FINAL part333B H.J. Harkins Company, Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 1000 [USP'U]/g; [USP'U]/g 52959-055_7f84a5cf-17aa-4078-ba9c-89dfb8ea349b 52959-055 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19841107 ANDA ANDA062396 H.J. Harkins Company, Inc. DOXYCYCLINE HYCLATE 100 mg/1 52959-074_104d12ea-e22c-46e6-b3c6-7bb45c4c01c9 52959-074 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 H.J. Harkins Company, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 52959-075_cc7aabc5-f1ea-49d9-ba81-267b65bbbef4 52959-075 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 H.J. Harkins Company, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-076_eb1eee33-fb71-41fc-9a72-162d81554a16 52959-076 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 H.J. Harkins Company, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-077_eb1eee33-fb71-41fc-9a72-162d81554a16 52959-077 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 H.J. Harkins Company, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-084_36912c86-f160-4e1b-8fef-a0552745e1c3 52959-084 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19960828 ANDA ANDA064065 H.J. Harkins Company, Inc. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 52959-085_f32260ef-31d9-4446-9111-ed69225e75fc 52959-085 HUMAN PRESCRIPTION DRUG Neomycin Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19950913 ANDA ANDA064135 H.J. Harkins Company, Inc. DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52959-088_3cdbfc16-f665-44dd-be3f-2053f5efd394 52959-088 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 19950601 OTC MONOGRAPH FINAL part333C H.J. Harkins Company, Inc. CLOTRIMAZOLE 1 g/100g 52959-089_663612a7-60b5-43b7-9b9a-91cff028cb97 52959-089 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 H.J. Harkins Company, Inc. LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52959-095_0806c64e-e77d-4aa8-ad24-67714b5c5148 52959-095 HUMAN OTC DRUG Medrox METHYL SALICYLATE, MENTHOL, CAPSAICIN OINTMENT TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part348 H.J. Harkins Company, Inc. CAPSAICIN; MENTHOL; METHYL SALICYLATE .0375; 5; 20 g/100g; g/100g; g/100g 52959-096_0899cb6a-c841-479f-aabb-28560c1fda74 52959-096 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20060928 ANDA ANDA086414 H.J. Harkins Company, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52959-099_70dca5f7-12fd-4c32-860c-d814f646c769 52959-099 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19871101 ANDA ANDA084276 H.J. Harkins Company, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 52959-102_9a58a7ae-3045-4b63-bd19-97f74582edc3 52959-102 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20111007 ANDA ANDA070033 H.J. Harkins Company, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 52959-108_859bbd86-adb6-433d-8ff5-71a754b306b7 52959-108 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 19931129 ANDA ANDA064052 H.J. Harkins Company, Inc. TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 52959-113_cad74dc9-a202-4e5d-b927-b2251079a170 52959-113 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20100108 OTC MONOGRAPH FINAL part333B H.J. Harkins Company, Inc. BACITRACIN ZINC 500 [USP'U]/g 52959-116_01a96480-6037-4c00-8f36-f3413fd796df 52959-116 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 H.J. Harkins Company, Inc. FAMOTIDINE 40 mg/1 52959-117_629fd51c-0ad7-4ea2-9661-1d654bcbbd17 52959-117 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SOLUTION OPHTHALMIC 20030325 ANDA ANDA089560 H.J. Harkins Company, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 52959-119_91b582b6-c0b5-477e-bf84-cb198a6151bd 52959-119 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040778 H.J. Harkins Company, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-122_76f29754-8711-434f-9548-837d2d608cfd 52959-122 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl Phenazopyridine HCl TABLET ORAL 20100910 UNAPPROVED DRUG OTHER H.J. Harkins Company, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 52959-124_cfb7782a-0363-4ea1-a7cc-259afa5336d1 52959-124 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20080923 ANDA ANDA078930 H.J. Harkins Company, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52959-126_65be80e7-696c-4442-a683-38bbb6eddcba 52959-126 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 H.J. Harkins Company, Inc. PREDNISONE 10 mg/1 52959-127_0fbab6d8-b9d9-4e8a-8023-3df614071406 52959-127 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 H.J. Harkins Company, Inc. PREDNISONE 20 mg/1 52959-129_85ad079e-088c-493d-bd2a-deaa107391bc 52959-129 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20070131 ANDA ANDA077712 H.J. Harkins Company, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-130_0438b837-f7ec-4c37-ae80-eafff9e3360b 52959-130 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 ANDA ANDA091313 H.J. Harkins Company, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-131_85ad079e-088c-493d-bd2a-deaa107391bc 52959-131 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20090302 ANDA ANDA077712 H.J. Harkins Company, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-132_150cd716-8f3b-4890-807f-8a54ecc9e183 52959-132 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100820 ANDA ANDA040807 H.J. Harkins Company, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 52959-134_71d6b94b-c32f-441c-89d5-a105afab79ea 52959-134 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20080823 ANDA ANDA065434 H.J. Harkins Company, Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52959-138_3ac644a7-eb27-4023-b211-d9ed9c38c4e8 52959-138 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080317 NDA NDA022195 H.J. Harkins Company, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-144_7b3d09bc-e5df-4fcf-941b-c19686900623 52959-144 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 H.J. Harkins Company, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 52959-145_aa8209f7-358e-4f9c-aaaf-1bde912f0a68 52959-145 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19810714 ANDA ANDA087425 H.J. Harkins Company, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] 52959-159_525aa3b8-7fde-4683-959e-d3da10140cb1 52959-159 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20060811 ANDA ANDA076369 H.J. Harkins Company, Inc. PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] 52959-167_70dca5f7-12fd-4c32-860c-d814f646c769 52959-167 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19871101 ANDA ANDA084277 H.J. Harkins Company, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 52959-182_3ac644a7-eb27-4023-b211-d9ed9c38c4e8 52959-182 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080317 NDA NDA022195 H.J. Harkins Company, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-185_a0844f71-fb93-4a00-9908-dad2df9fdae7 52959-185 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 H.J. Harkins Company, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-187_6608c82e-6913-4928-b4fb-3815863ce2d0 52959-187 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 OTC MONOGRAPH NOT FINAL part343 H.J. Harkins Company, Inc. IBUPROFEN 200 mg/1 52959-191_e0716b0d-f797-4807-a4ef-81e8262b246f 52959-191 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 H.J. Harkins Company, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-195_91275e67-c112-480e-b4c9-1de9f51ac081 52959-195 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 19900403 ANDA ANDA071795 H.J. Harkins Company, Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-204_68fe3dfd-c27f-4558-b1b1-6aff37213809 52959-204 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20070905 ANDA ANDA078251 H.J. Harkins Company, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52959-219_7ec07ddf-81e2-435e-8836-0fb4e238fe35 52959-219 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 H.J. Harkins Company, Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 52959-220_0781aefd-3c65-4a2f-9369-661c7c4bfe70 52959-220 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 H.J. Harkins Company, Inc. PREDNISONE 5 mg/1 52959-221_c5e71cb1-0d6c-47fa-b809-2182932ab3db 52959-221 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 H.J. Harkins Company, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 52959-225_8602b88e-b064-49c4-a224-11829d706003 52959-225 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087127 H.J. Harkins Company, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 52959-232_bd59acb2-4996-4167-a558-00c59a0653d0 52959-232 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20120416 ANDA ANDA074131 H.J. Harkins Company, Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-236_534aaa8b-7a83-4a14-9c08-c1972632fc26 52959-236 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 19861208 ANDA ANDA071108 H.J. Harkins Company, Inc. FLURAZEPAM HYDROCHLORIDE 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52959-245_5fdf2c0a-67e1-44ca-9561-2caaf8d5ec9b 52959-245 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 20110118 ANDA ANDA073516 H.J. Harkins Company, Inc. KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-260_68ccbad3-6dd8-41d3-8eb2-7babb7d1a44a 52959-260 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 19941001 OTC MONOGRAPH FINAL part341 H.J. Harkins Company, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 52959-265_fceefb90-8d05-40f0-b612-107685339aff 52959-265 HUMAN PRESCRIPTION DRUG PREDNISOLONE ACETATE prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19970819 NDA AUTHORIZED GENERIC NDA017011 H.J. Harkins Company, Inc. PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52959-271_454a1424-a79e-4678-b54f-ea82d88a123e 52959-271 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen TABLET ORAL 20070701 ANDA ANDA078250 H.J. Harkins Company, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-282_fc96693f-ed3b-4a38-b082-f7e43df9de65 52959-282 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 H.J. Harkins Company, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 52959-289_a0862d45-3327-433a-9d0d-2928a4327527 52959-289 HUMAN PRESCRIPTION DRUG VIRACEPT nelfinavir mesylate TABLET, FILM COATED ORAL 19970314 NDA NDA020779 H.J. Harkins Company, Inc. NELFINAVIR MESYLATE 250 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 52959-296_7062e52f-035a-4d55-ba37-1b8ccc0ed7ef 52959-296 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 H.J. Harkins Company, Inc. AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 52959-298_f91e8d59-64bf-479c-b56a-f9e55489940d 52959-298 HUMAN OTC DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 19990207 ANDA ANDA074937 H.J. Harkins Company, Inc. IBUPROFEN 100 mg/5mL 52959-300_e39e2622-3fbf-474b-9c32-f052dc1a7eb2 52959-300 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET ORAL 20051208 ANDA ANDA065276 H. J. Harkins Company, Inc. CEFPROZIL 500 mg/1 52959-301_78d48e3a-2b53-489c-8961-3444d25a4a6c 52959-301 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940729 ANDA ANDA064067 H.J. Harkins Company, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52959-303_dbcf8a7d-54ef-41ef-b7d6-7b0ad073a7b4 52959-303 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA077135 H.J. Harkins Company, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 52959-305_bf8b4d41-0381-4c4e-9f08-0adf34f0e98c 52959-305 HUMAN PRESCRIPTION DRUG Rimantadine Hydrochloride Rimantadine Hydrochloride TABLET, FILM COATED ORAL 20050401 ANDA ANDA076132 H.J. Harkins Company, Inc. RIMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 52959-308_14405431-115c-417b-918e-17a63bb6042a 52959-308 HUMAN PRESCRIPTION DRUG Cefuroxime axetil Cefuroxime axetil TABLET, FILM COATED ORAL 20101201 ANDA ANDA065496 H.J. Harkins Company, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52959-309_c0665cc5-d9f4-406b-b3c3-3b1c751de3d5 52959-309 HUMAN OTC DRUG Acetaminophen Acetaminophen LIQUID ORAL 19940905 OTC MONOGRAPH NOT FINAL part343 H.J. Harkins Company, Inc. ACETAMINOPHEN 160 mg/5mL 52959-336_b921807d-5d59-4548-af3c-4152820b1465 52959-336 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20100323 ANDA ANDA060704 H.J. Harkins Company, Inc. TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 52959-338_976d0a7b-0607-453e-82df-3eb3fa19d1ce 52959-338 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN TABLET, FILM COATED ORAL 20110504 OTC MONOGRAPH FINAL part343 H.J. Harkins Company, Inc. ACETAMINOPHEN 500 mg/1 52959-348_a90b16ab-0c90-4e42-a281-7989f2158ebe 52959-348 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 H.J. Harkins Company, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 52959-370_463f3a60-1b30-4487-be79-2aa3cea75a51 52959-370 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine TABLET ORAL 19790605 ANDA ANDA086162 H.J. Harkins Company ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 52959-386_8a7832fd-a24f-43b5-b46c-6043dfb24114 52959-386 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20090519 ANDA ANDA040517 H.J. Harkins Company Inc. METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-389_8cd46ed0-6629-479f-9c35-22fbeb811d71 52959-389 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 19880225 ANDA ANDA062882 H.J. Harkins Company, Inc. AMPICILLIN TRIHYDRATE 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 52959-392_32aeebab-9a83-4b11-8f29-a5e1fa2dc274 52959-392 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088160 H.J. Harkins Company, Inc. DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52959-398_bd59acb2-4996-4167-a558-00c59a0653d0 52959-398 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20120416 ANDA ANDA074131 H.J. Harkins Company, Inc. PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-400_9a58a7ae-3045-4b63-bd19-97f74582edc3 52959-400 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20111007 ANDA ANDA070027 H.J. Harkins Company, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 52959-406_a0844f71-fb93-4a00-9908-dad2df9fdae7 52959-406 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 H.J. Harkins Company, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-408_0a9c8629-be18-4f5d-8f19-e96b46d63dbd 52959-408 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA078439 H.J. Harkins Company, Inc. HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-410_1f3bb40a-4eff-4c11-b55b-89a3f8425118 52959-410 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 H.J. Harkins Company, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 52959-411_1f3bb40a-4eff-4c11-b55b-89a3f8425118 52959-411 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 H.J. Harkins Company, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 52959-413_0a9c8629-be18-4f5d-8f19-e96b46d63dbd 52959-413 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA077471 H.J. Harkins Company, Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-420_0a9c8629-be18-4f5d-8f19-e96b46d63dbd 52959-420 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA078439 H.J. Harkins Company, Inc. HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-423_6029c68a-8374-48c7-8690-74347e623cfe 52959-423 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 H.J. Harkins Company, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-428_142c98e2-4356-4f18-a596-90fddd02d067 52959-428 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20080401 ANDA ANDA065392 H.J. Harkins Company, Inc. CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52959-432_39c69ed9-e45d-4099-b249-ddf710527e3c 52959-432 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 H.J. Harkins Company, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 52959-433_f261ce7f-663b-4ca6-9ee3-215ec8eeb9c4 52959-433 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20100701 ANDA ANDA088496 H.J. Harkins Company, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 52959-435_8a7832fd-a24f-43b5-b46c-6043dfb24114 52959-435 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20090519 ANDA ANDA040517 H.J. Harkins Company Inc. METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-441_7e3a6da2-f432-4a62-ab53-c305587b7726 52959-441 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 H.J. Harkins Company, Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52959-450_9d232871-21b7-423b-8c70-ed1bdd8901a0 52959-450 HUMAN PRESCRIPTION DRUG Next Choice levonorgestrel TABLET ORAL 20090904 ANDA ANDA078665 H.J. Harkins Company, Inc. LEVONORGESTREL .75 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 52959-459_54f020bf-54a5-4a05-98f2-c7ca8e25be3f 52959-459 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 H.J. Harkins Company, Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52959-463_c9ff7aa4-60d8-40e5-867a-f5af6cefe49a 52959-463 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 H.J. Harkins Company, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 52959-466_f145684a-097f-472a-a9fb-ed6c513cdc71 52959-466 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 H.J. Harkins Company, Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 52959-469_2f8a9fb7-d0df-4362-a206-38c6a4291fd6 52959-469 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET ORAL 19970109 ANDA ANDA074661 H.J. Harkins Company, Inc. NAPROXEN SODIUM 220 mg/1 52959-471_fa86884d-639e-4a55-8038-650350c81462 52959-471 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980520 ANDA ANDA075009 H.J. Harkins Company, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-510_cf6af122-0acc-4dcf-8d52-5f283c6f0666 52959-510 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 H.J. Harkins Company, Inc. SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 52959-512_8e1a80b4-ffb1-424c-b35d-4986fa74e21f 52959-512 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20100420 ANDA ANDA074754 H.J. Harkins Company, Inc. KETOROLAC TROMETHAMINE 10 mg/1 52959-514_a90b16ab-0c90-4e42-a281-7989f2158ebe 52959-514 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 H.J. Harkins Company, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 52959-516_8aaccad1-9c53-4d0d-a05f-b1a1f7c77d1f 52959-516 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 20100923 ANDA ANDA075227 H.J. Harkins Company, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-517_316f8dac-8a38-4351-819e-9e5d5fc38c50 52959-517 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20110527 ANDA ANDA074578 H.J. Harkins Company, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 52959-518_94fc9e99-c19d-4e8c-91be-b469ec44513d 52959-518 HUMAN PRESCRIPTION DRUG Flector Diclofenac Epolamine PATCH TOPICAL 20080114 NDA NDA021234 H.J. Harkins Company, Inc. DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-527_2637a5d7-26be-4a9b-ad46-b9d96d929e3c 52959-527 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE ORAL 20000623 ANDA ANDA040368 H.J. Harkins Company, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 52959-534_d6d3bcd7-acb0-47a0-a19c-33be09363bb3 52959-534 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 H.J. Harkins Company, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52959-535_54f020bf-54a5-4a05-98f2-c7ca8e25be3f 52959-535 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 H.J. Harkins Company, Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52959-539_fa8f4605-2a86-49f2-8a42-d706ce01a5b0 52959-539 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 H.J. Harkins Company, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-540_fa8f4605-2a86-49f2-8a42-d706ce01a5b0 52959-540 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 H.J. Harkins Company, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-546_37641156-8d51-4e36-abb6-b46cb9e7f828 52959-546 HUMAN PRESCRIPTION DRUG COMBIVIR lamivudine and zidovudine TABLET, FILM COATED ORAL 20101019 NDA NDA020857 H.J. Harkins Company, Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 52959-547_32aeebab-9a83-4b11-8f29-a5e1fa2dc274 52959-547 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088238 H.J. Harkins Company, Inc. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52959-548_319f79f5-a83e-4c51-b362-c01eb43d5ed6 52959-548 HUMAN PRESCRIPTION DRUG Transmucosal Fentanyl Citrate fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 20060906 NDA NDA020747 H.J. Harkins Company, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-549_319f79f5-a83e-4c51-b362-c01eb43d5ed6 52959-549 HUMAN PRESCRIPTION DRUG Transmucosal Fentanyl Citrate fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 20060906 NDA NDA020747 H.J. Harkins Company, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-556_4bedcdef-76de-40e6-ad2b-241fbb6fabe7 52959-556 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 19960730 ANDA ANDA040105 H.J. Harkins Company, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-557_a00f72d8-4467-49b3-b8c5-51789b941b7f 52959-557 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20050121 ANDA ANDA076673 H.J. Harkins Company, Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52959-558_7f846eba-4489-4e7d-85fc-586ac9830380 52959-558 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 19871222 ANDA ANDA062364 H.J. Harkins Company, Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52959-566_319f79f5-a83e-4c51-b362-c01eb43d5ed6 52959-566 HUMAN PRESCRIPTION DRUG Transmucosal Fentanyl Citrate fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 20060906 NDA NDA020747 H.J. Harkins Company, Inc. FENTANYL CITRATE 1200 1/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-579_b13e2d13-40f5-49d3-8558-4ac6186eb853 52959-579 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19970623 NDA NDA020592 H.J. Harkins Company, Inc. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 52959-585_62e84ab2-d304-4595-a918-6939ea7cc7b7 52959-585 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 H.J. Harkins Company, Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-593_360650e7-757b-462f-8518-ffc103c71bc7 52959-593 HUMAN PRESCRIPTION DRUG Multi-Vitamin Fluoride Drops Vitamin A, Vitamin C, Vitamin D, Vitamin E, Vitamin B1, Vitamin B2, Vitamin B12, Niacin, Vitamin B6, Flouride SOLUTION ORAL 20110504 UNAPPROVED DRUG OTHER H.J. Harkins Company, Inc. .ALPHA.-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FLUORIDE ION; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A 5; 35; 400; 2; .25; 8; .4; .6; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 52959-595_db7aec8b-4f85-4358-ba86-b5cbffb6a986 52959-595 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076631 H.J. Harkins Company, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 52959-596_96bd5ba7-4885-4069-976d-eb4949445264 52959-596 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 H.J. Harkins Company, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 52959-604_5faa9dae-bc3e-4a04-8909-94d8133f8e53 52959-604 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 H.J. Harkins Company, Inc. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] 52959-609_998080ce-a00c-4518-92fd-a985679ad681 52959-609 HUMAN PRESCRIPTION DRUG POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate SOLUTION/ DROPS OPHTHALMIC 19970429 NDA AUTHORIZED GENERIC NDA050567 H.J. Harkins Company, Inc. POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 52959-613_f97f68a9-f15b-4a49-8a24-89b2e31992cb 52959-613 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 H.J. Harkins Company, Inc. AMOXICILLIN 250 mg/5mL 52959-620_2d3e1047-9978-4400-a4bd-76aff63420a6 52959-620 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin FOR SUSPENSION ORAL 20050801 ANDA ANDA065234 H.J. Harkins Company, Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52959-629_0e8477f6-fc7d-4ccd-a064-5c5d75f331af 52959-629 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20110721 NDA NDA021366 H.J. Harkins Company, Inc. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52959-630_8a441358-7fed-46d1-9401-ba50193cc639 52959-630 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 H.J. Harkins Company, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52959-635_e76af339-d18b-4736-8c5f-571f0fdef293 52959-635 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 19970918 NDA NDA018578 H.J. Harkins Company, Inc. SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 52959-643_1e56d689-84c0-41f2-a236-b02329ad276a 52959-643 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 H.J. Harkins Company, Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52959-650_0ebcf6fc-a0cf-491d-b833-42ac160dc5e0 52959-650 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 H.J. Harkins Company, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-652_baed54e9-abeb-436b-bb53-114bd11e8001 52959-652 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide GEL TOPICAL 20110120 ANDA ANDA072537 H.J. Harkins Company, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52959-653_0a0823ba-8547-46bb-84de-076196f6a913 52959-653 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE, COATED ORAL 20010701 ANDA ANDA065028 H.J. Harkins Company, Inc. RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 52959-655_1a55e010-4f16-4082-be02-77d7777f8c09 52959-655 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100201 ANDA ANDA075491 H.J. Harkins Company, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 52959-656_0ebcf6fc-a0cf-491d-b833-42ac160dc5e0 52959-656 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 H.J. Harkins Company, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-658_724f7d0e-6859-4bb9-abd5-8d3cd456475a 52959-658 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 H.J. Harkins Company, Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 52959-659_a346079a-144b-47b0-ba63-cd3db2c05ce2 52959-659 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 20100121 ANDA ANDA075219 H.J. Harkins Company, Inc. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-662_809b4fca-b61c-4d90-93f6-745346012c86 52959-662 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20110504 ANDA ANDA070791 H.J. Harkins Company, Inc. DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 52959-675_e57a4e72-fd3d-44fa-96ca-06ea1d477cc8 52959-675 HUMAN OTC DRUG SENEXON-S DOCUSATE SODIUM -SENNOSIDES TABLET, COATED ORAL 20110316 OTC MONOGRAPH NOT FINAL part334 H.J. Harkins Company, Inc. DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 52959-676_d48ce370-755e-4da3-bd60-fd91433924ae 52959-676 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20101223 ANDA ANDA075022 H.J. Harkins Company, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 52959-677_0d3ec116-a621-4f15-bc56-c63487a319bc 52959-677 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100715 ANDA ANDA072235 H.J. Harkins Company, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 52959-689_efa8102d-2da1-4d92-b884-fd9c8bd80383 52959-689 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 H.J. Harkins Company, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 52959-691_efa8102d-2da1-4d92-b884-fd9c8bd80383 52959-691 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 H.J. Harkins Company, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 52959-692_9355aee3-c2a5-485f-ae95-cf93bfc0a57f 52959-692 HUMAN PRESCRIPTION DRUG misoprostol misoprostol TABLET ORAL 20091227 NDA NDA019268 H.J. Harkins Company, Inc. MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 52959-694_87ad1d5c-248a-4a38-94dc-0ab9b07704dc 52959-694 HUMAN PRESCRIPTION DRUG LIDODERM lidocaine PATCH CUTANEOUS 19990320 NDA NDA020612 H.J. Harkins Company, Inc. LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 52959-702_9404bff5-10f1-4359-8894-b6a5cb5ae198 52959-702 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20110125 ANDA ANDA065101 H.J. Harkins Company, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 52959-705_a979a931-8857-48a2-b369-d17c814d7ece 52959-705 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19950929 ANDA ANDA040074 H.J. Harkins Company, Inc. PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] 52959-707_9404bff5-10f1-4359-8894-b6a5cb5ae198 52959-707 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20110125 ANDA ANDA065096 H.J. Harkins Company, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 52959-721_ca18345d-d08a-4be6-a006-49ecdd06ab30 52959-721 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 19840226 ANDA ANDA019137 H.J. Harkins Company, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52959-722_beac7b55-14cd-45b4-8024-bd117222e6cc 52959-722 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20110114 ANDA ANDA075876 H.J. Harkins Company, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 52959-728_b6067e83-6c20-4902-84db-cf26f1c3c005 52959-728 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20051117 ANDA ANDA077321 H.J. Harkins Company, Inc. LISINOPRIL 10 mg/1 52959-730_9adbd7e3-4ea3-4ef7-8112-a6a0c31b4b6a 52959-730 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 H.J. Harkins Company, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52959-731_a69a3507-3ae2-4226-86e6-3cc872ad2fdb 52959-731 HUMAN PRESCRIPTION DRUG PROMETHEGAN PROMETHAZINE HYDROCHLORIDE SUPPOSITORY RECTAL 20020228 ANDA ANDA040428 H.J. Harkins Company, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52959-733_0d3ec116-a621-4f15-bc56-c63487a319bc 52959-733 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100715 ANDA ANDA072234 H.J. Harkins Company, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 52959-734_9adbd7e3-4ea3-4ef7-8112-a6a0c31b4b6a 52959-734 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 H.J. Harkins Company, Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52959-737_5f3f6e79-7f2f-4cba-9631-bdf030400172 52959-737 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 H.J. Harkins Company, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 52959-738_f6e09c02-e9e8-4099-b9cf-00d9ebac732f 52959-738 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100118 ANDA ANDA076642 H.J. Harkins Company, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 52959-739_9adbd7e3-4ea3-4ef7-8112-a6a0c31b4b6a 52959-739 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 H.J. Harkins Company, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52959-740_2aadfde6-5a06-4a2c-b249-c3ff844145d4 52959-740 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 H.J. Harkins Company, Inc. LORATADINE 10 mg/1 52959-743_09fcfeb2-8e52-4417-86b5-63688d9ede45 52959-743 HUMAN PRESCRIPTION DRUG mupirocin Mupirocin OINTMENT TOPICAL 20091030 ANDA ANDA065123 H.J. Harkins Company, Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 52959-746_4c9b2c15-78b0-42b1-a146-026282c33076 52959-746 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 H.J. Harkins Company, Inc. PREGABALIN 100 mg/1 CV 52959-747_4c9b2c15-78b0-42b1-a146-026282c33076 52959-747 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 H.J. Harkins Company, Inc. PREGABALIN 75 mg/1 CV 52959-757_3b0ebf5d-a084-4322-a1f4-602566b5a9c2 52959-757 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 H.J. Harkins Company, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52959-761_8a441358-7fed-46d1-9401-ba50193cc639 52959-761 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 H.J. Harkins Company, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52959-763_b0521d4d-afba-41bf-a921-1dc4a277e5f7 52959-763 HUMAN PRESCRIPTION DRUG ofloxacin ofloxacin SOLUTION OPHTHALMIC 20100104 ANDA ANDA078559 H.J. Harkins Company, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 52959-766_1fc8d359-d5b3-42ac-82c4-cc0ebe609198 52959-766 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 19971229 ANDA ANDA074650 H.J. Harkins Company, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 52959-772_1199caa8-cf89-4168-94d1-56bd48557325 52959-772 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 H.J. Harkins Company, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52959-773_3ccdc4a4-7388-4383-964b-1e964890e1d1 52959-773 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20090101 ANDA ANDA077031 H.J. Harkins Company, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52959-775_176f9d8a-7d2d-4830-abe6-91e32cdf58f5 52959-775 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 H.J. Harkins Company, Inc. PAROXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52959-776_176f9d8a-7d2d-4830-abe6-91e32cdf58f5 52959-776 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 H.J. Harkins Company, Inc. PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52959-789_1199caa8-cf89-4168-94d1-56bd48557325 52959-789 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 H.J. Harkins Company, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52959-800_f180bf54-c92f-4597-ab9c-a91543ceedf6 52959-800 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20010131 ANDA ANDA075855 H.J. Harkins Company, Inc. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-803_656a1145-8596-45aa-b59e-14b986d8ff76 52959-803 HUMAN PRESCRIPTION DRUG Mefloquine Hydrochloride Mefloquine Hydrochloride TABLET ORAL 20100421 ANDA ANDA077699 H.J. Harkins Company, Inc. MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC] 52959-806_6587b0ef-0ce7-4dca-96fb-b07fc0155fd2 52959-806 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 H.J. Harkins Company, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 52959-811_efdfe922-d360-43bc-b65c-245178658b4a 52959-811 HUMAN PRESCRIPTION DRUG TERCONAZOLE terconazole CREAM VAGINAL 20040401 NDA NDA019579 H.J. Harkins Company, Inc. TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 52959-812_4dac9654-cf35-4ad6-ba88-ccabe84069b0 52959-812 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040527 H.J. Harkins Company, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 52959-814_37302f24-ba1e-4146-b42c-549a8dd0e9e3 52959-814 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED ORAL 20051216 ANDA ANDA077184 H.J. Harkins Company, Inc. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 52959-822_ad2e35e9-f17a-4a7a-a19d-bfe7af334161 52959-822 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 H.J. Harkins Company, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 52959-824_6dce31da-352d-47ef-9f8d-d4e2466a06a1 52959-824 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20020709 ANDA ANDA075616 H.J. Harkins Company, Inc. NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 52959-838_004b13ef-8ffb-434a-9abd-18085b6a0793 52959-838 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 H.J. Harkins Company, Inc. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 52959-852_feff9e75-95ba-4fb3-b286-c363cf4ea678 52959-852 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 H.J. Harkins Company, Inc. ESZOPICLONE 3 mg/1 CIV 52959-872_a62fcc0d-ac44-43dd-b293-8e0204d7f882 52959-872 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 H.J. Harkins Company Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52959-875_a62fcc0d-ac44-43dd-b293-8e0204d7f882 52959-875 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 H.J. Harkins Company Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52959-876_a62fcc0d-ac44-43dd-b293-8e0204d7f882 52959-876 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 H.J. Harkins Company Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52959-880_67208dcd-25ba-45c9-9e5e-b71747ec6493 52959-880 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 H.J. Harkins Company, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 52959-890_ad9cf8c5-39b6-451c-9fb1-d0ec1bf08679 52959-890 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 H.J. Harkins Company, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52959-891_4c9b2c15-78b0-42b1-a146-026282c33076 52959-891 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 H.J. Harkins Company, Inc. PREGABALIN 50 mg/1 CV 52959-892_908e6b8e-0116-4024-bcb4-4f27938301a6 52959-892 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20100115 NDA NDA021427 H.J. Harkins Company, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 52959-897_4c9b2c15-78b0-42b1-a146-026282c33076 52959-897 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 H.J. Harkins Company, Inc. PREGABALIN 150 mg/1 CV 52959-902_6dadb3b7-2077-4b27-b8b6-529e8698deca 52959-902 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 H.J. Harkins Company, Inc. MIRTAZAPINE 30 mg/1 52959-913_6c1d025f-a760-406b-80ea-b514f4dbf47d 52959-913 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030825 ANDA ANDA040513 H.J. Harkins Company, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 52959-919_feff9e75-95ba-4fb3-b286-c363cf4ea678 52959-919 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 H.J. Harkins Company, Inc. ESZOPICLONE 2 mg/1 CIV 52959-920_663612a7-60b5-43b7-9b9a-91cff028cb97 52959-920 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 H.J. Harkins Company, Inc. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 52959-930_57e42715-7a47-401c-826d-2cf23e0bf6f0 52959-930 HUMAN OTC DRUG Dendracin Neurodendraxcin Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20110722 OTC MONOGRAPH NOT FINAL part348 H.J. Harkins Company, Inc. CAPSAICIN; MENTHOL; METHYL SALICYLATE .015; 6; 18 mL/60mL; mL/60mL; mL/60mL 52959-939_35941438-1b02-495d-9333-f10c681f67dd 52959-939 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 H.J. Harkins Company, Inc. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 52959-940_5db5cff3-00dc-4766-abff-66800c268e61 52959-940 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, SUGAR COATED ORAL 19981231 ANDA ANDA040226 H.J. Harkins Company, Inc. PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 52959-941_7ec07ddf-81e2-435e-8836-0fb4e238fe35 52959-941 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 H.J. Harkins Company, Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 52959-944_06f70227-6ba1-462b-bc45-6d4082eb3f90 52959-944 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 H.J. Harkins Company, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52959-957_f99f26bc-5e6c-4b5a-9657-6bc3861fa5e5 52959-957 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20101215 ANDA ANDA078989 H.J. Harkins Company, Inc. ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 52959-961_d9ec869c-720d-49a2-8d4c-f13a5c972e1f 52959-961 HUMAN PRESCRIPTION DRUG Halobetasol Propionate Halobetasol Propionate OINTMENT TOPICAL 20090205 ANDA ANDA076872 H.J. Harkins Company, Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52959-965_75fcb860-7243-49d6-8ae2-7cd989588e52 52959-965 HUMAN PRESCRIPTION DRUG ALPRAZOLAM EXTENDED-RELEASE ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070328 ANDA ANDA077996 H.J. Harkins Company, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 52959-969_33319495-9b23-4a6e-8473-226da2b5d927 52959-969 HUMAN PRESCRIPTION DRUG Truvada emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20040802 NDA NDA021752 H.J. Harkins Company, Inc. EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 52959-978_f3f4a975-d44b-4a91-af1a-b660b1ebb06a 52959-978 HUMAN PRESCRIPTION DRUG PROAIRHFA HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20041201 NDA NDA021457 H.J. Harkins Company, Inc. ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 52959-983_be7d9791-f676-426c-ba46-6dbaced723af 52959-983 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 H.J. Harkins Company, Inc. ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 52959-984_fb0e30f7-a594-40cf-b56c-a45cfbcd60d8 52959-984 HUMAN PRESCRIPTION DRUG Tobramycin and Dexamethasone Tobramycin and Dexamethasone SUSPENSION OPHTHALMIC 20090102 NDA AUTHORIZED GENERIC NDA050592 H.J. Harkins Company, Inc. DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 52959-987_1fb5dcde-d854-4df6-8fc7-35affe0adc11 52959-987 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION/ DROPS OPHTHALMIC 20071228 ANDA ANDA078792 H.J. Harkins Company, Inc. DICLOFENAC SODIUM 1 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 52959-989_06f70227-6ba1-462b-bc45-6d4082eb3f90 52959-989 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 H.J. Harkins Company, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 52959-991_100ad196-b283-436d-9e09-40b89418afce 52959-991 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077517 H.J. Harkins Company, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 52959-994_7e3a6da2-f432-4a62-ab53-c305587b7726 52959-994 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 H.J. Harkins Company, Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 52959-997_f19695c2-e2df-4059-9ec1-98c498baad15 52959-997 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20100101 ANDA ANDA076265 H.J. Harkins Company, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 52960-101_46279779-1009-4416-a80a-f3f94ada7d9f 52960-101 HUMAN OTC DRUG iBlanc Restora-Bright Acne Healing BENZOYL PEROXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH FINAL part333D iBlanc Inc. BENZOYL PEROXIDE 5.3 g/100g 52960-201_d21fa970-c7f7-4f19-af10-15beec658272 52960-201 HUMAN OTC DRUG iBlanc Restora-Bright Elite Natural Sun Defense SPF 30 ZINC OXIDE LOTION TOPICAL 20120923 OTC MONOGRAPH FINAL part352 iBlanc, Inc. ZINC OXIDE 13.5 g/100g 52964-1001_4f9da83d-75f7-47c1-8bfc-9d78267c9e9a 52964-1001 HUMAN OTC DRUG BiPla SUS SCROFA PLACENTA LIQUID ORAL 20120802 UNAPPROVED DRUG OTHER TMN K.K. SUS SCROFA PLACENTA 16000 mg/30mL 52970-010_a886da8d-2d5f-4b58-8138-e1dd0e67654d 52970-010 HUMAN OTC DRUG ROVECTIN Anti irritant Barrier Repair Ultra Dimethicone CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 SECOND FORMULA INC. DIMETHICONE 1.8 g/100mL 52979-8001_37cb1daa-53df-4044-bcf3-0b860daae921 52979-8001 HUMAN OTC DRUG Angel Falls Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part333E CUARTA DIMENSION USA, INC. ALCOHOL 62 mL/100mL 52979-8002_6e94033b-8053-4217-b6a7-6a13a1b1f2d8 52979-8002 HUMAN OTC DRUG Lemon Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part333E CUARTA DIMENSION USA, INC. ALCOHOL 62 mL/100mL 52979-8003_807654d2-14bd-4727-9b26-be5bb3851ea9 52979-8003 HUMAN OTC DRUG Love Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part333E CUARTA DIMENSION USA, INC. ALCOHOL 62 mL/100mL 52979-8004_af966462-4af8-4356-a71f-38c547e43189 52979-8004 HUMAN OTC DRUG Under Paris Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part333E CUARTA DIMENSION USA, INC. ALCOHOL 62 mL/100mL 52979-8005_8f86f141-d8f6-4980-a3a3-bf4b570ef952 52979-8005 HUMAN OTC DRUG Vinotinto Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part333E CUARTA DIMENSION USA, INC. ALCOHOL 62 mL/100mL 52979-8006_7081459b-5588-45cf-a51e-e7562e9c5a44 52979-8006 HUMAN OTC DRUG Water Mountain Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part333E CUARTA DIMENSION USA, INC. ALCOHOL 62 mL/100mL 52982-100_99f39d62-8c04-4e61-8e95-5d350ba548f0 52982-100 HUMAN OTC DRUG Your Logo Here Antiseptic First Aid benzocaine and benzethonium chloride AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Dixon Investments, Inc. BENZETHONIUM CHLORIDE; BENZOCAINE 170; 8500 mg/85g; mg/85g 52982-101_627ccdf1-c3e9-4ca9-945d-0945bfe4d2c6 52982-101 HUMAN OTC DRUG Your Logo Here Burn First Aid benzocaine, benzethonium chloride, and menthol AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Dixon Investments, Inc. BENZETHONIUM CHLORIDE; BENZOCAINE; MENTHOL 170; 8500; 281 mg/85g; mg/85g; mg/85g 52982-105_411ce50b-61f6-4144-ac47-278492e9276c 52982-105 HUMAN OTC DRUG Your Logo Here Bandage Aid benzethonium chloride and benzocaine AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part333A Dixon Investments, Inc. BENZETHONIUM CHLORIDE; BENZOCAINE 170; 2720 mg/85g; mg/85g 52982-106_e7170a92-c40d-4771-b99f-99e3371f16c3 52982-106 HUMAN OTC DRUG Your Label Here Blood Clotting First Aid benzethonium chloride and lidocaine AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Dixon Investments, Inc. BENZETHONIUM CHLORIDE; LIDOCAINE 170; 3400 mg/85g; mg/85g 52982-107_8b2cea63-310d-4960-bbcb-4243adb855bd 52982-107 HUMAN OTC DRUG Your Logo Here Poison Ivy First Aid benzethonium chloride and benzocaine AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Dixon Investments, Inc. BENZETHONIUM CHLORIDE; BENZOCAINE 127.5; 4250 mg/85g; mg/85g 52982-120_96b179c7-bc85-441a-a78d-774d787b1fcc 52982-120 HUMAN OTC DRUG Your Logo Here Antiseptic First Aid benzalkonium chloride and lidocaine SPRAY, METERED TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Dixon Investments, Inc. BENZALKONIUM CHLORIDE; LIDOCAINE 107.1; 1912.5 mg/90mL; mg/90mL 52982-121_64e5cbb3-590a-4c53-bcb6-0f9e06e20dfc 52982-121 HUMAN OTC DRUG Your Logo Here Burn First Aid benzalkonium chloride and benzocaine SPRAY, METERED TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Dixon Investments, Inc. BENZALKONIUM CHLORIDE; BENZOCAINE 107.1; 3825 mg/90mL; mg/90mL 52982-124_d1423cdc-e1b0-4d7a-bed6-cb6b218950f1 52982-124 HUMAN OTC DRUG Your Label Here Hydrogen Peroxide First Aid hydrogen peroxide SPRAY, METERED TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part356 Dixon Investments, Inc. HYDROGEN PEROXIDE 3.57 mL/119mL 52993-001_5561332c-193a-4b77-80f4-9eb7b401c1a3 52993-001 HUMAN OTC DRUG Zinka Clear Zinc Oxide Sunscreen Octinoxate, Zinc Oxide, Octisalate, Oxybenzone LOTION TOPICAL 20070301 OTC MONOGRAPH FINAL part352 Zinka, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 50; 30; 25; 43 mg/g; mg/g; mg/g; mg/g 52993-110_c7e72d26-9723-4b11-97d9-8f5b8f7f1b9b 52993-110 HUMAN OTC DRUG Zinka Lemon Twist SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20140509 OTC MONOGRAPH NOT FINAL part352 Zinka OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 42 mg/g; mg/g; mg/g 52993-111_662cac4f-c42b-4ec5-b8da-7a0819e481db 52993-111 HUMAN OTC DRUG Zinka Passion Fruit SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20140509 OTC MONOGRAPH NOT FINAL part352 Zinka OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 42 mg/g; mg/g; mg/g 52993-112_05c2271c-88a5-4b9f-81c1-8fc17778005e 52993-112 HUMAN OTC DRUG Zinka Watermelon SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20140509 OTC MONOGRAPH NOT FINAL part352 Zinka OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 42 mg/g; mg/g; mg/g 52993-125_e35d0ef5-787b-4cec-be5e-0f0c418c42fc 52993-125 HUMAN OTC DRUG Zinka Lip Protector SPF 30 Lip Balm Octinoxate, Octisalate, Octocrylene, Oxybenzone STICK TOPICAL 20140509 OTC MONOGRAPH NOT FINAL part352 Zinka OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 10; 5 mg/g; mg/g; mg/g; mg/g 52993-150_94e23afd-05ca-4f6b-82af-0bccf702f198 52993-150 HUMAN OTC DRUG Zinka SPF 50 Facestick Homosalate, Octinoxate, Octisalate, Octocrylene, Zinc Oxide STICK TOPICAL 20140509 OTC MONOGRAPH NOT FINAL part352 Zinka HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 6.9; 4.7; 4; 3.4; 5 mg/g; mg/g; mg/g; mg/g; mg/g 53009-1001_3eb0940e-e197-43cc-bc9a-7d01dcf61dd1 53009-1001 HUMAN OTC DRUG MIOGGI Healing Effector RX Collagenic ADENOSINE CREAM TOPICAL 20120820 UNAPPROVED DRUG OTHER Colorpink R&D Inc. ADENOSINE .02 mg/50mL 53009-2001_2c6f47a0-36a3-4fd0-a303-d409f91031e0 53009-2001 HUMAN OTC DRUG MIOGGI Magic Advanced Skin Essential Activator ADENOSINE LIQUID TOPICAL 20120820 UNAPPROVED DRUG OTHER Colorpink R&D Inc. ADENOSINE .05 mg/125mL 53010-1001_39cf1622-867f-49b6-a7e3-4bbb4b2d65b2 53010-1001 HUMAN OTC DRUG JNH Dr. Intensive Plus UV Protector TITANIUM DIOXIDE CREAM TOPICAL 20120824 UNAPPROVED DRUG OTHER Daeduck Lab Co., Ltd TITANIUM DIOXIDE 1.5 g/50g 53010-2001_0e59f98d-b9f0-40f8-bebf-fb07d759ce75 53010-2001 HUMAN OTC DRUG JNH Magic BB SIMMONDSIA CHINENSIS SEED CREAM TOPICAL 20120824 UNAPPROVED DRUG OTHER Daeduck Lab Co., Ltd SIMMONDSIA CHINENSIS SEED .9 g/30g 53010-3001_4c7b2fdb-3890-443e-a3cf-5eac1e2d0266 53010-3001 HUMAN OTC DRUG JNH Ato-Care Super Barried ATO-Serum CERAMIDE 3 LIQUID TOPICAL 20120824 UNAPPROVED DRUG OTHER Daeduck Lab Co., Ltd CERAMIDE 3 1.5 mg/50mL 53010-4001_061f3424-9b50-4e27-9a7e-657d6fdfa55f 53010-4001 HUMAN OTC DRUG JNH a-Clear Resurface Sulfur GLYCERIN GEL TOPICAL 20141015 OTC MONOGRAPH FINAL part347 Daeduck Lab Co., Ltd. GLYCERIN 2 g/100g 53010-5001_053f57e6-b21d-471d-91c8-727b4dde0575 53010-5001 HUMAN OTC DRUG JNH a-Clear Propolis Spot Serum GLYCERIN LIQUID TOPICAL 20141015 OTC MONOGRAPH FINAL part347 Daeduck Lab Co., Ltd. GLYCERIN 2 g/100mL 53014-250_c753dc4b-db00-43cc-ace2-82c2e5e3686f 53014-250 HUMAN PRESCRIPTION DRUG Pediapred prednisolone sodium phosphate SOLUTION ORAL 19860528 NDA NDA019157 UCB Manufacturing, Inc. PREDNISOLONE SODIUM PHOSPHATE 6.7 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 53014-530_cbb7eb03-57e6-4a38-8d1b-110236208ede 53014-530 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 19771223 ANDA ANDA085799 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 53014-531_cbb7eb03-57e6-4a38-8d1b-110236208ede 53014-531 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 19790404 ANDA ANDA086429 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 53014-532_cbb7eb03-57e6-4a38-8d1b-110236208ede 53014-532 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 19790404 ANDA ANDA086428 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 53014-548_698f17a7-c06a-4566-a360-862f34e8ec8a 53014-548 HUMAN PRESCRIPTION DRUG Tussionex Pennkinetic hydrocodone polistirex and chlorpheniramine polistirex SUSPENSION, EXTENDED RELEASE ORAL 19871231 NDA NDA019111 Unither Manufacturing, LLC CHLORPHENIRAMINE; HYDROCODONE 8; 10 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII 53014-579_e92e08d8-03be-4729-b124-82c333cbc633 53014-579 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030812 NDA NDA021259 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 53014-580_e92e08d8-03be-4729-b124-82c333cbc633 53014-580 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030218 NDA NDA021259 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 53014-581_e92e08d8-03be-4729-b124-82c333cbc633 53014-581 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030722 NDA NDA021259 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 53014-582_e92e08d8-03be-4729-b124-82c333cbc633 53014-582 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20060321 NDA NDA021259 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 53014-583_e92e08d8-03be-4729-b124-82c333cbc633 53014-583 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20060321 NDA NDA021259 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 53014-584_e92e08d8-03be-4729-b124-82c333cbc633 53014-584 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20060321 NDA NDA021259 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 60 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 53014-594_6470b9ad-04b8-4386-b2c3-184518ac6957 53014-594 HUMAN PRESCRIPTION DRUG Metadate ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 19880601 ANDA ANDA089601 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 53014-850_0a931952-d6e6-4c16-8c6d-201886ccd149 53014-850 HUMAN PRESCRIPTION DRUG Zaroxolyn metolazone TABLET ORAL 19731127 NDA NDA017386 UNITHER Manufacturing LLC METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 53014-975_0a931952-d6e6-4c16-8c6d-201886ccd149 53014-975 HUMAN PRESCRIPTION DRUG Zaroxolyn metolazone TABLET ORAL 19731127 NDA NDA017386 UNITHER Manufacturing LLC METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 53017-801_308cc173-b808-453a-986e-e103e1085370 53017-801 HUMAN OTC DRUG Branders Antiseptic Hand Sanitizer ETHYL ALCOHOL SPRAY TOPICAL 20120718 OTC MONOGRAPH NOT FINAL part333E BRANDERS.COM, INC. ALCOHOL 62 mL/100mL 53017-802_18437382-0d51-4cc3-97d0-bb6a00ed7700 53017-802 HUMAN OTC DRUG Branders Antiseptic Hand Sanitizer ETHYL ALCOHOL SPRAY TOPICAL 20120718 OTC MONOGRAPH NOT FINAL part333E BRANDERS.COM, INC. ALCOHOL 62 mL/100mL 53028-1001_81b999e3-a6b9-4c8d-b26e-fbeab7bee7ab 53028-1001 HUMAN OTC DRUG Armarita Sulfur LIQUID VAGINAL 20120802 OTC MONOGRAPH FINAL part333D JG Select Inc SULFUR .12 mg/3mL 53033-001_752587cb-6a25-4404-aad9-66269dbe1052 53033-001 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120824 OTC MONOGRAPH FINAL part333A Pioneer Associates ISOPROPYL ALCOHOL 50 mL/100mL 53033-002_140428ad-3067-4cd4-a460-01f55aa0c683 53033-002 HUMAN OTC DRUG Isopropyl Rubbing Alcohol with Wintergreen Oil Isopropyl Alcohol LIQUID TOPICAL 20120824 OTC MONOGRAPH FINAL part333A Pioneer Associates ISOPROPYL ALCOHOL 50 mL/100mL 53033-003_001adbf8-50c8-44e1-9c78-4993c42c27b1 53033-003 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20120824 OTC MONOGRAPH NOT FINAL part333A Pioneer Associates HYDROGEN PEROXIDE 3 mL/100mL 53033-004_5784d32a-bb75-44c3-a350-3b84904e7777 53033-004 HUMAN OTC DRUG CAVALIER Fresh Scent Petrolatum OINTMENT TOPICAL 20121031 OTC MONOGRAPH FINAL part347 Imperial Bag & Paper Co.,LLC dba Pioneer Associates PETROLATUM 99.9 g/100g 53033-005_6b46d8ac-6e3d-4b2e-be1b-8d164858bb00 53033-005 HUMAN OTC DRUG CAVALIER Petrolatum OINTMENT TOPICAL 20121031 OTC MONOGRAPH FINAL part347 Imperial Bag & Paper Co.,LLC dba Pioneer Associates PETROLATUM 99.9 g/100g 53033-006_1a4b1b2d-9a15-4818-a2d3-2bd974c3b142 53033-006 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20130205 OTC MONOGRAPH NOT FINAL part333A Pioneer Associates ISOPROPYL ALCOHOL 70 mL/100mL 53033-007_5879b3dc-779f-4cfe-93ab-1a8a80eaffd2 53033-007 HUMAN OTC DRUG ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN OIL Isopropyl Alcohol LIQUID TOPICAL 20130205 OTC MONOGRAPH NOT FINAL part333A Pioneer Associates ISOPROPYL ALCOHOL 70 mL/100mL 53034-404_a8b5ef40-7131-4246-8b93-bd7595c21ca8 53034-404 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20110818 ANDA ANDA091211 Clinical Solutions ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 53038-001_839595c6-2058-4fd5-8bef-9926662ad528 53038-001 HUMAN OTC DRUG Friccilicont Menthol, Methyl Salicylate CREAM TOPICAL 20120815 OTC MONOGRAPH NOT FINAL part348 Labocont Industrial MENTHOL; METHYL SALICYLATE 3; 10 g/100g; g/100g 53040-993_95630b62-2ac7-46b2-ba5b-6367e6a18120 53040-993 HUMAN OTC DRUG The Fresh Market Hand Sanitizer With Moisturizers Aloe And Vitamin E ALCOHOL GEL TOPICAL 20120802 OTC MONOGRAPH FINAL part333E The Fresh Market ALCOHOL 65 mL/100mL 53040-994_b355d08b-5225-4d92-81eb-70800df51870 53040-994 HUMAN OTC DRUG The Fresh Market Hand Sanitizer Alcohol Free BENZALKONIUM CHLORIDE GEL TOPICAL 20120802 OTC MONOGRAPH FINAL part333E The Fresh Market BENZALKONIUM CHLORIDE 1.3 mg/mL 53040-995_24d8d5a2-7b65-40a7-9864-b80896444b20 53040-995 HUMAN OTC DRUG The Fresh Market SPF 15 Lip Balm Broad Spectrum Acai Berry AVOBENZONE, OCTINOXATE, OXYBENZONE STICK TOPICAL 20120802 OTC MONOGRAPH FINAL part352 The Fresh Market AVOBENZONE; OCTINOXATE; OXYBENZONE 2; 7.5; 3.5 g/100g; g/100g; g/100g 53040-996_0f842c68-0ace-4165-aa76-07e71343a423 53040-996 HUMAN OTC DRUG The Fresh Market Medicated Lip Balm Soothing With Menthol Eucalyptus Oil And Clove MENTHOL STICK TOPICAL 20120802 OTC MONOGRAPH FINAL part348 The Fresh Market MENTHOL .6 g/100g 53041-128_87b18d62-d760-46b7-a5b5-331ef7defcba 53041-128 HUMAN OTC DRUG Foamcoat Antacid Aluminum hydroxide, Magnesium carbonate TABLET, CHEWABLE ORAL 20050404 OTC MONOGRAPH FINAL part331 Guardian Drug Company ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 53041-147_a144fbe3-7130-4cb4-9c22-b5c3e8fb94cb 53041-147 HUMAN OTC DRUG Fiber Caps Calcium polycarbophil TABLET, FILM COATED ORAL 20100715 OTC MONOGRAPH NOT FINAL part334 Guardian Drug Company CALCIUM POLYCARBOPHIL 625 mg/1 53041-152_4961737d-229c-4289-836e-5165220f8821 53041-152 HUMAN OTC DRUG Alumox Aluminum Hydroxide, Magnesium Hydroxide, Simethicone TABLET, CHEWABLE ORAL 20040606 OTC MONOGRAPH FINAL part331 Guardian Drug Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 25; 200 mg/1; mg/1; mg/1 53041-159_c4045bad-c868-4d8d-ab83-f26fbdb1aac2 53041-159 HUMAN OTC DRUG Senna-Lax Sennosides TABLET ORAL 20020202 OTC MONOGRAPH NOT FINAL part334 Guardian Drug Company SENNOSIDES 8.6 mg/1 53041-401_3c4af140-a8d1-4085-9343-92c5bea6c3da 53041-401 HUMAN OTC DRUG Natural Fiber Psyllium husk POWDER, FOR SUSPENSION ORAL 20030101 OTC MONOGRAPH NOT FINAL part334 GUARDIAN DRUG COMPANY PSYLLIUM HUSK 3.4 g/7g 53041-402_8c2bf44f-be7c-4e3b-ba4b-d758b04d3976 53041-402 HUMAN OTC DRUG Original Texture, Orange Flavor psyllium husk POWDER, FOR SUSPENSION ORAL 20030101 OTC MONOGRAPH NOT FINAL part334 Guardian Drug Company PSYLLIUM HUSK 3.4 g/11g 53041-403_ffb94e19-4002-43c7-8374-de5517ab6600 53041-403 HUMAN OTC DRUG Smooth texture Orange flavor psyllium husk POWDER, FOR SUSPENSION ORAL 20030101 OTC MONOGRAPH NOT FINAL part334 Guardian PSYLLIUM HUSK 3.4 g/12g 53041-405_1787aec2-b365-4d67-80a6-fc0fe1f781d1 53041-405 HUMAN OTC DRUG Guardian psyllium husk POWDER, FOR SUSPENSION ORAL 20010101 OTC MONOGRAPH NOT FINAL part334 Guardian PSYLLIUM HUSK 3.4 g/5.8g 53041-412_44954519-b178-45df-aeb3-44e0a331cef5 53041-412 HUMAN OTC DRUG Sugar Free Smooth Texture, Berry Flavor psyllium husk POWDER, FOR SUSPENSION ORAL 20120101 OTC MONOGRAPH NOT FINAL part334 Guardian Drug Company PSYLLIUM HUSK 3.4 g/5.8g 53041-527_fdb49e2e-e093-4fbc-9c8d-3e7b632710c2 53041-527 HUMAN OTC DRUG Pink-Bismuth Bismuth Subsalicylate LIQUID ORAL 20080530 OTC MONOGRAPH FINAL part335 Guardian Drug Company BISMUTH SUBSALICYLATE 262 mg/15mL 53041-577_43b4f37f-5ec3-4888-8174-011414db2ea3 53041-577 HUMAN OTC DRUG Childrens Metapp Daytime Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20120606 OTC MONOGRAPH FINAL part341 Guardian Drug Company BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 53041-615_7f5007ce-e8df-4be8-a965-236341719bdc 53041-615 HUMAN OTC DRUG Childrens Tussnex Multi-symptom cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Guardian Drug Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 53041-616_1d066711-15e9-4fc2-a241-79fcfd6d2741 53041-616 HUMAN OTC DRUG Tussnex FM Cold and Sinus Acteaminophen, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Guardian Drug Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL 53041-617_ca149b66-2e20-42e9-bb68-49e4bcd0c23f 53041-617 HUMAN OTC DRUG Tussnex FM Severe cough and congestion Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Guardian Drug Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL 53041-618_290cc80d-c9d8-4f26-80eb-c289c6cb9272 53041-618 HUMAN OTC DRUG Tussnex FM Cold, Flu and Sore Throat Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Guardian Drug Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL 53041-622_3a42dca8-725c-44a6-bcac-4c4da8c47446 53041-622 HUMAN OTC DRUG Childrens Tussnex Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20120505 OTC MONOGRAPH FINAL part341 Guardian Drug Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL 53041-628_fbaba20c-3fd0-4277-b00c-8f0d0312bcec 53041-628 HUMAN OTC DRUG Maximum strength Tussnex FM DM Max Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20120501 OTC MONOGRAPH FINAL part341 Guardian Drug Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL 53041-650_c6047f86-9687-4c3c-b70e-71d65b526e29 53041-650 HUMAN OTC DRUG Natural Fiber Psyllium Husk CAPSULE ORAL 20030101 OTC MONOGRAPH NOT FINAL part334 Guardian Drug Company PSYLLIUM HUSK .52 g/1 53043-001_56d787bf-d7c2-463b-aac7-b00dcfdb2230 53043-001 HUMAN OTC DRUG Pain ReliefPatches Patches DL-Camphor L-Menthol Methyl Salicylate PATCH TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part348 Shanghai Aquagel Bio-Plymer Co., Ltd CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 1.2; 4; 6.3 mL/100mL; mL/100mL; mL/100mL 53043-003_8dccfbae-5bf0-4c02-8c03-da491358efa7 53043-003 HUMAN OTC DRUG Mini Pain Relief DL-Camphor L-Menthol Methyl Salicylate PATCH TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part348 Shanghai Aquagel Bio-Plymer Co., Ltd CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 1.2; 2.7; 2.5 mg/1; mg/1; mg/1 53045-100_f5e4326e-617a-430c-bd41-f3602cc3fd08 53045-100 HUMAN OTC DRUG Opahl Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g 53045-101_fbef86e1-96fa-41b5-bf4a-a944ddc64355 53045-101 HUMAN OTC DRUG Opahl Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g 53045-102_4320cd62-0107-4aec-9ec1-ab24e87fa181 53045-102 HUMAN OTC DRUG Opahl Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g 53045-103_045a70a9-e15b-4b7c-bc16-ceac8b4018cb 53045-103 HUMAN OTC DRUG Opahl Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g 53045-104_ca47b255-9f1b-4850-80c5-d8e10c154a6e 53045-104 HUMAN OTC DRUG Opahl Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g 53045-105_f0f5891f-8538-4838-a82f-48c12cafcdb2 53045-105 HUMAN OTC DRUG Opahl Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g 53045-106_84ff0f16-188d-4e79-bac0-268a973d2e74 53045-106 HUMAN OTC DRUG Opahl Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g 53045-107_77633a8a-bc4a-4b7d-bf4e-0139d349ebf3 53045-107 HUMAN OTC DRUG Opahl Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g 53045-112_2a5c883b-8eea-4a9c-8a64-341f313e8a2f 53045-112 HUMAN OTC DRUG Opahl Dye Free Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g 53045-125_c2ad7bd9-78c9-40d9-9d3f-8e3c56de6036 53045-125 HUMAN PRESCRIPTION DRUG Opahl Benzocaine SPRAY, METERED DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. BENZOCAINE 12 g/60g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 53045-200_e00740db-2621-42f7-973d-aefb79199b32 53045-200 HUMAN PRESCRIPTION DRUG Ionite APF Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 10.241 g/490g 53045-201_f7ce2c5f-a151-4f1e-87e5-1ad161cbda53 53045-201 HUMAN PRESCRIPTION DRUG Ionite APF Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 10.241 g/490g 53045-202_7bdc5337-13b7-411d-aee1-580c72d53430 53045-202 HUMAN PRESCRIPTION DRUG Ionite APF Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 6.027 g/490g 53045-203_dba99f17-55e9-4bf7-964f-f7476ea450cb 53045-203 HUMAN PRESCRIPTION DRUG Ionite APF Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 6.027 g/490g 53045-204_2ca7c53d-6021-49a1-99a4-a244f198f218 53045-204 HUMAN PRESCRIPTION DRUG Ionite APF Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 6.027 g/490g 53045-205_16feddba-f871-4445-a788-904bafb375be 53045-205 HUMAN PRESCRIPTION DRUG Ionite APF Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 6.027 g/490g 53045-206_e21e9d7a-4abd-4831-9268-5de2ed7212bc 53045-206 HUMAN PRESCRIPTION DRUG Ionite APF Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 6.027 g/490g 53045-207_a662954e-0102-419f-add4-e05b4f865e36 53045-207 HUMAN PRESCRIPTION DRUG Ionite APF Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 6.027 g/490g 53045-235_062028c9-c82d-49d7-b0ef-27cb99d69e7f 53045-235 HUMAN PRESCRIPTION DRUG Ionite APF Neutral Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 4.41 g/490g 53045-237_48d0d960-21a1-4f26-8814-c54f93657458 53045-237 HUMAN PRESCRIPTION DRUG Ionite APF Neutral Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 4.41 g/490g 53045-250_b10324c7-9eec-4c91-8961-77f992c3d9c9 53045-250 HUMAN PRESCRIPTION DRUG Ionite APF Foam Sodium Fluoride AEROSOL, FOAM DENTAL; ORAL; TOPICAL 20130422 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 1.5498 g/126g 53045-251_f3d95782-692c-4e95-8860-5d3eb83f9fb3 53045-251 HUMAN PRESCRIPTION DRUG Ionite APF Foam Sodium Fluoride AEROSOL, FOAM DENTAL; ORAL; TOPICAL 20130422 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 1.5498 g/126g 53045-252_3f553fd8-38b6-4bf8-b816-cb6085a61866 53045-252 HUMAN PRESCRIPTION DRUG Ionite APF Foam Sodium Fluoride AEROSOL, FOAM DENTAL; ORAL; TOPICAL 20130422 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 1.5498 g/126g 53045-253_50ebddb4-1050-4c81-bba3-803182f83490 53045-253 HUMAN PRESCRIPTION DRUG Ionite APF Foam Sodium Fluoride AEROSOL, FOAM DENTAL; ORAL; TOPICAL 20130422 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 1.5498 g/126g 53045-265_892f5bdc-eabb-4942-925e-93164f9fc826 53045-265 HUMAN PRESCRIPTION DRUG Ionite R Sodium Fluoride LIQUID DENTAL; ORAL 20131103 UNAPPROVED DRUG OTHER Dharma Research, Inc. SODIUM FLUORIDE 38 g/L 53045-266_76cc9393-6ce4-405e-a58f-25a630c64586 53045-266 HUMAN PRESCRIPTION DRUG Ionite R Sodium Fluoride LIQUID DENTAL; ORAL 20131103 UNAPPROVED DRUG OTHER Dharma Research, Inc. SODIUM FLUORIDE 38 g/L 53045-300_ee0790f9-cba0-410b-ab2d-928f73577f21 53045-300 HUMAN PRESCRIPTION DRUG Frenna AC Aluminum Chloride SOLUTION DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. ALUMINUM CHLORIDE 8.75 g/35g 53050-001_af46a613-3839-43b2-b4ba-c670ee4dd6e9 53050-001 HUMAN OTC DRUG Ora 2 stain clear SODIUM FLUORIDE PASTE DENTAL 20120822 OTC MONOGRAPH FINAL part355 Sunstar Guangzhou Ltd. SODIUM FLUORIDE .1 g/100g 53057-001_29e8572d-eca8-48e2-bf33-c598ee7cb30b 53057-001 HUMAN OTC DRUG Holiday ElegancePeppermint Twist Peppermint Twist Peppermint Twist Triclosan LIQUID TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Triz Laboratories Ltd. TRICLOSAN .9 g/300g 53057-002_62ce880a-41e4-4249-9ab3-de171894e641 53057-002 HUMAN OTC DRUG Holiday EleganceFrosted Gingerbre Frosted Gingerbread Triclosan LIQUID TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Triz Laboratories Ltd. TRICLOSAN .9 g/300g 53057-003_6b62d2f9-8a73-491b-85e7-09ffcb26e684 53057-003 HUMAN OTC DRUG Holiday EleganceFrosted GingerbreFrosted Gingerbre Frosted Gingerbread Triclosan LIQUID TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Triz Laboratories Ltd. TRICLOSAN .9 g/300g 53057-004_831980c1-7a52-4738-b386-68347544775b 53057-004 HUMAN OTC DRUG Holiday Elegance Triclosan LIQUID TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Triz Laboratories Ltd. TRICLOSAN .9 g/300g 53057-005_2b4a0e0a-4267-45cc-a9b9-5d6294ef83e1 53057-005 HUMAN OTC DRUG Spatherapy ALCOHOL LOTION TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL 53057-006_8f31c072-3796-44bb-9a56-3bbb7b869aea 53057-006 HUMAN OTC DRUG Spatherapy ALCOHOL LOTION TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL 53057-007_44ea0d93-a9aa-4aa6-b27f-f3acbd82ade1 53057-007 HUMAN OTC DRUG Spatherapy ALCOHOL LOTION TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL 53057-008_2d837034-d369-40f2-a478-845742b7551e 53057-008 HUMAN OTC DRUG Spatherapy ALCOHOL LOTION TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL 53057-009_63e31e49-1e1b-4b9c-ad25-5218dc4ba21d 53057-009 HUMAN OTC DRUG Spatherapy ALCOHOL LOTION TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL 53057-010_80d0b06d-33dc-49e0-a3f0-d1d3228e0344 53057-010 HUMAN OTC DRUG Spatherapy ALCOHOL LOTION TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL 53057-012_418c2099-c2b5-4822-85f8-709a3ec36f0e 53057-012 HUMAN OTC DRUG Wilde Orchid ALCOHOL GEL TOPICAL 20140513 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL 53057-013_870271d8-75c8-4c55-922f-345ff0ba71b6 53057-013 HUMAN OTC DRUG Mojito Sun ALCOHOL GEL TOPICAL 20140513 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL 53057-014_89d25aeb-bf1e-4586-b9e3-206b34ca891c 53057-014 HUMAN OTC DRUG Hibiscus Breeze ALCOHOL GEL TOPICAL 20140513 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL 53057-015_2ad615c7-31f1-4a36-8020-bf5604c4e0bf 53057-015 HUMAN OTC DRUG Pineapple Paradise ALCOHOL GEL TOPICAL 20140513 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL 53057-016_4c331c73-4229-4168-9e23-22e57e507010 53057-016 HUMAN OTC DRUG Passion Fruit Kiss ALCOHOL GEL TOPICAL 20140513 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL 53063-1111_103a9da4-2804-4d50-8d0a-e909419e60ea 53063-1111 HUMAN OTC DRUG GO TIME Ammonia INHALANT RESPIRATORY (INHALATION) 20120813 UNAPPROVED DRUG OTHER Mountain Top Labs, LLC AMMONIA .013 mL/.3mL 53063-1112_4baf36af-8252-4501-9ebb-a10ac9770cc6 53063-1112 HUMAN OTC DRUG GO TIME Ammonia INHALANT RESPIRATORY (INHALATION) 20120813 UNAPPROVED DRUG OTHER Mountain Top Labs, LLC AMMONIA .013 mL/.3mL 53063-1113_ae3e24ae-ab8b-46af-a0db-1ba9a3802bc6 53063-1113 HUMAN OTC DRUG GO TIME Ammonia INHALANT RESPIRATORY (INHALATION) 20120813 UNAPPROVED DRUG OTHER Mountain Top Labs, LLC AMMONIA .013 mL/.3mL 53063-1114_d743ad4a-55a4-4423-913c-2a79c0b29829 53063-1114 HUMAN OTC DRUG GO TIME Ammonia INHALANT RESPIRATORY (INHALATION) 20120813 UNAPPROVED DRUG OTHER Mountain Top Labs, LLC AMMONIA .013 mL/.3mL 53077-1001_f0d5d34f-d6a8-4258-be05-a48de4d64200 53077-1001 HUMAN OTC DRUG Dr. Dream Advanced Facial Treatment Toner WITCH HAZEL LIQUID TOPICAL 20120824 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL 53077-2001_6446c71b-fc50-435d-bb7d-a2c9747efa78 53077-2001 HUMAN OTC DRUG Dr. Dream Advanced Facial Treatment Serum WITCH HAZEL LIQUID TOPICAL 20120824 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL 53077-3001_155a6e4e-66d3-482d-b87c-6f0f738849d0 53077-3001 HUMAN OTC DRUG Dr. Dream Advanced Facial Treatment Serum WITCH HAZEL CREAM TOPICAL 20120824 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL 53077-4001_799beb8a-c90d-42c1-ae35-4005b4a661c1 53077-4001 HUMAN OTC DRUG Dr. Dream Advanced Eye Treatment WITCH HAZEL CREAM TOPICAL 20120925 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL 53077-5001_2f12c08e-d3b3-48f5-96b1-84ec8c2b3550 53077-5001 HUMAN OTC DRUG Dr. Dream Cold Plazma Whitening WITCH HAZEL CREAM TOPICAL 20120925 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL 53077-6001_397c9841-889b-4506-8484-68275df31a5f 53077-6001 HUMAN OTC DRUG Dr. Dream Hydramemory Deep active Moisturizer WITCH HAZEL CREAM TOPICAL 20120925 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL 53077-7001_c4f3ef23-cc82-4b15-b096-476aecf63b7f 53077-7001 HUMAN OTC DRUG Dr. Dream Cold Plazma Whitening Serum WITCH HAZEL LIQUID TOPICAL 20120925 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL 53077-8001_df111fe1-ee11-4eb7-92f0-dc85906e0995 53077-8001 HUMAN OTC DRUG Dr. Dream Urban Protective Advanced BB WITCH HAZEL CREAM TOPICAL 20120925 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL 53077-9001_066ec298-4562-4b32-993c-9ddc7815a070 53077-9001 HUMAN OTC DRUG Dr. Dream Hydramemory Deep Cleansing WITCH HAZEL LIQUID TOPICAL 20120925 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL 53080-000_384b2a10-b73e-4c09-af57-9bbaa368452c 53080-000 HUMAN OTC DRUG Antiseptic Hand Sanitizing Wipe Enriched With Vitamin E And Aloe Vera ALCOHOL LIQUID TOPICAL 20120829 OTC MONOGRAPH FINAL part333E Delta ALCOHOL 75 g/100g 53080-001_ad03339f-17e2-491d-9735-7e686e2225e3 53080-001 HUMAN OTC DRUG Delta Airline Ron Kit Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130510 OTC MONOGRAPH FINAL part355 Delta SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 53083-001_c5d56da7-e6dc-4fa8-891b-4ebe48d8fb91 53083-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20120601 UNAPPROVED MEDICAL GAS B & R Welder Repair Service, Inc OXYGEN 995 mL/L 53093-433_59295ea1-e6a6-42df-8716-b25605d52a69 53093-433 HUMAN OTC DRUG Motto sulfur PATCH TRANSDERMAL 20130310 OTC MONOGRAPH FINAL part333D Motto-Elektro Ltd. SULFUR 9 mg/9mg 53097-101_25df123f-198d-49d8-9573-1b94a01140d3 53097-101 HUMAN PRESCRIPTION DRUG Thermazene Silver Sulfadiazine CREAM TOPICAL 20130701 NDA NDA018810 The Pharma Network LLC SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 53104-0100_7aa03290-2101-43a8-b306-58a5ea679e9f 53104-0100 HUMAN PRESCRIPTION DRUG Zidovudine zidovudine CAPSULE ORAL 20070523 ANDA ANDA078349 Cipla Limited ZIDOVUDINE 100 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53104-0101_3856f9f3-e17e-40c5-943d-c8673007b848 53104-0101 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20101027 ANDA ANDA090561 Cipla Limited ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53104-0105_162f189e-0376-4b95-bbde-aa2ee6e488b5 53104-0105 HUMAN PRESCRIPTION DRUG zidovudine zidovudine SYRUP ORAL 20080626 ANDA ANDA077981 Cipla Limited ZIDOVUDINE 50 mg/5mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53104-0111_7e130f8d-4de7-434d-b00f-33b45f1e7d71 53104-0111 HUMAN PRESCRIPTION DRUG stavudine stavudine FOR SOLUTION ORAL 20090320 ANDA ANDA078030 Cipla Limited STAVUDINE 1 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53104-0151_851894a7-97eb-4d90-b7e8-0fb950bc0dc2 53104-0151 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION INTRAVENOUS 20080220 ANDA ANDA077219 Cipla Limited IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 53104-0166_ea55503a-daca-4686-bca5-fd70b239596a 53104-0166 HUMAN PRESCRIPTION DRUG nevirapine nevirapine TABLET ORAL 20120522 ANDA ANDA077956 Cipla Limited NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 53113-100_a6f37e88-1493-4c23-8f17-3136964406ca 53113-100 HUMAN OTC DRUG Ice Quake Menthol GEL TOPICAL 20120823 OTC MONOGRAPH FINAL part348 Gadal Laboratories, Inc. MENTHOL 16.95 g/113g 53113-101_64688b81-89cb-42bc-a7fe-8491b179911e 53113-101 HUMAN OTC DRUG Gadavyt Magnesium Citrate LIQUID ORAL 20121001 OTC MONOGRAPH FINAL part334 Gadal Laboratories Inc MAGNESIUM CITRATE 1.745 g/29.6mL 53113-102_73057da3-ee31-4a5b-ba89-ca89b4d31895 53113-102 HUMAN OTC DRUG Gadavyt Magnesium Citrate LIQUID ORAL 20121001 OTC MONOGRAPH FINAL part334 Gadal Laboratories Inc MAGNESIUM CITRATE 1.745 g/29.6mL 53113-103_f7e99784-d9f8-4c5f-8957-d178e8c0b351 53113-103 HUMAN OTC DRUG Gadavyt Magnesium Citrate LIQUID ORAL 20121001 OTC MONOGRAPH FINAL part334 Gadal Laboratories Inc MAGNESIUM CITRATE 1.745 g/29.6mL 53113-104_b41d79c8-cdd2-410e-9921-3ca86f040b8f 53113-104 HUMAN OTC DRUG Gadavyt Enema dibasic sodium phosphate, monobasic sodium phosphate LIQUID RECTAL 20121001 OTC MONOGRAPH NOT FINAL part334 Gadal Laboratories Inc SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 53113-105_d273c7e7-0dc8-4921-84d2-cf77f1f777eb 53113-105 HUMAN OTC DRUG Gadavyt Enema dibasic sodium phosphate, monobasic sodium phosphate LIQUID RECTAL 20121001 OTC MONOGRAPH NOT FINAL part334 Gadal Laboratories Inc SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 3.5; 9.5 g/59mL; g/59mL 53113-108_3a135d16-cb5f-4ec6-815f-9993a96763cb 53113-108 HUMAN OTC DRUG Ice Quake Muscle Rub Menthol GEL TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Gadal Laboratories Inc MENTHOL 2 g/100g 53113-215_c84aa6c7-3e51-4b6a-9fee-e6af3856f0ae 53113-215 HUMAN OTC DRUG Broncomar Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20140601 OTC MONOGRAPH FINAL part341 Gadal Laboratories Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 250; 13.33; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL 53113-216_9093948c-6ef7-48ce-b023-8d979a924cde 53113-216 HUMAN OTC DRUG Broncomar Maximum Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140601 OTC MONOGRAPH FINAL part341 Gadal Laboratories Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30; 200 mg/10mL; mg/10mL 53113-217_19ec0ebe-5667-42f4-b790-076aa1d008b7 53113-217 HUMAN OTC DRUG Broncomar DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140601 OTC MONOGRAPH FINAL part341 Gadal Laboratories Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 53113-218_1f890f7c-0ae0-4746-ad5e-de73ba503801 53113-218 HUMAN OTC DRUG Broncomar SF Guaifenesin LIQUID ORAL 20140601 OTC MONOGRAPH FINAL part341 Gadal Laboratories Inc GUAIFENESIN 100 mg/5mL 53113-262_18d0cac1-584a-4679-8888-65051e73ebbd 53113-262 HUMAN OTC DRUG Gadaderm Hydrocortisone Hydrocortisone Acetate CREAM TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part348 Gadal Laboratories Inc HYDROCORTISONE ACETATE .5 g/100g 53113-263_6636e999-6ece-4cab-8f36-1feb1802e9d1 53113-263 HUMAN OTC DRUG Gadaderm Antifungal Tolnaftate CREAM TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Gadal Laboratories Inc TOLNAFTATE 1 g/100g 53113-266_f7c673c3-0b90-48b7-8b40-39179f3b79d8 53113-266 HUMAN OTC DRUG Ice Quake Plus Methyl Salicylate, Menthol, Camphor GEL TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Gadal Laboratories Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3.1; 10; 10 g/100g; g/100g; g/100g 53113-550_4ef93a86-4d13-4465-bcb2-08367c587b23 53113-550 HUMAN OTC DRUG Gadavyt Cough GUAIFENESIN LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Gadal Laboratories Inc GUAIFENESIN 100 mg/5mL 53113-557_77ed1487-5de6-47c6-b4e1-abaf25512649 53113-557 HUMAN OTC DRUG Gadavyt Cough DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Gadal Laboratories Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 53113-657_7aa6375e-6789-4465-967b-9d3ddeac3635 53113-657 HUMAN OTC DRUG Gadavyt Loperamide HCl Loperamide Hydrochloride LIQUID ORAL 20130501 UNAPPROVED DRUG OTHER Gadal Laboratories Inc LOPERAMIDE HYDROCHLORIDE 1 mg/5mL 53113-688_6720c67b-21f5-485d-90e1-c40bad7dd1f6 53113-688 HUMAN OTC DRUG Ice Quake White Methyl Salicylate, Menthol CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Gadal Laboratories Inc MENTHOL; METHYL SALICYLATE 2; 8 g/100g; g/100g 53117-224_e0ac696c-5d90-4abb-ad6e-43e039c29fea 53117-224 HUMAN OTC DRUG fad first aid direct anti-diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20141015 ANDA ANDA075232 First Aid Direct LOPERAMIDE HYDROCHLORIDE 2 mg/1 53117-612_d86c8340-23f4-4e10-8634-ce7bc5fb3608 53117-612 HUMAN OTC DRUG fad first aid direct allergy relief Loratadine TABLET ORAL 20121219 ANDA ANDA076301 First Aid Direct LORATADINE 10 mg/1 53119-575_78e78f82-6420-4685-9d37-588346d05ef9 53119-575 HUMAN OTC DRUG TRICLOSAN TRICLOSAN LIQUID TOPICAL 20101011 OTC MONOGRAPH NOT FINAL part333A Columbia Jobbing TRICLOSAN 3.15 g/1000mL 53125-773_3c5a115e-f5cd-4303-86b1-4d888ad73958 53125-773 HUMAN OTC DRUG Sani Mousse ALCOHOL AEROSOL, FOAM TOPICAL 20120904 OTC MONOGRAPH NOT FINAL part333E Superior Chemical Corporation ALCOHOL 620 mg/g 53125-785_d04c7c23-545c-4bd9-9107-5a464042abc8 53125-785 HUMAN OTC DRUG Soapy Hands BENZETHONIUM CHLORIDE CLOTH TOPICAL 20120904 OTC MONOGRAPH NOT FINAL part333E Superior Chemical Corporation BENZETHONIUM CHLORIDE 2 mg/g 53135-825_1463ef83-ef5e-4eb6-bbf9-a8a63e6256ce 53135-825 HUMAN OTC DRUG Amazing Grace Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex gly STICK TOPICAL 20100228 OTC MONOGRAPH NOT FINAL part352 Raani Corporation ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g 53135-833_de59a033-f0e3-4fe6-8f26-c0891096390a 53135-833 HUMAN OTC DRUG ZUSKA VIVA ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20100123 OTC MONOGRAPH FINAL part350 RAANI CORPORATION ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 180 mg/g 53135-834_bc8fbd0e-5be6-49f9-a8bd-30d07dbfad5f 53135-834 HUMAN OTC DRUG ZUSKA VIVA DEODORANT PLUS ANTIPERSPIRANT STICK TOPICAL 20091123 OTC MONOGRAPH FINAL part350 RAANI CORPORATION ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 180 mg/g 53135-835_08968d67-89ec-4230-857d-7ff92a25d20d 53135-835 HUMAN OTC DRUG ZUSKA ODYSSEY ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20091123 OTC MONOGRAPH FINAL part350 RAANI CORPORATION ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 180 mg/g 53135-836_e37f4176-3b72-488e-bc69-ab0c190b6b59 53135-836 HUMAN OTC DRUG ZUSKA RHYTHM DEODORANT PLUS ANTIPERSPIRANT STICK TOPICAL 20091123 OTC MONOGRAPH FINAL part350 RAANI CORPORATION ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 180 mg/g 53135-837_93beac96-ca2e-46a2-9662-3e1d8d24acba 53135-837 HUMAN OTC DRUG ZUSKA ICON ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20091123 OTC MONOGRAPH FINAL part350 RAANI CORPORATION ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 180 mg/g 53135-838_d782bd0c-2708-45a8-a968-386fa85bdcde 53135-838 HUMAN OTC DRUG ZUSKA RHYTHM ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20101230 OTC MONOGRAPH FINAL part350 RAANI CORPORATION ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 180 mg/g 53135-925_8e1f802e-324e-47af-ba15-c35f4ec8690c 53135-925 HUMAN OTC DRUG Pure Grace Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20100228 OTC MONOGRAPH NOT FINAL part352 Raani Corporation ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g 53135-967_f977a79a-1650-4048-87fe-661a4c47f133 53135-967 HUMAN OTC DRUG LACURA FOR MEN ULTIMATE ENDURANCE Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20101108 OTC MONOGRAPH FINAL part350 RAANI CORPORATION ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 200 mg/g 53144-1001_9b035360-3432-44e8-9e2b-ff955422c493 53144-1001 HUMAN OTC DRUG Mesima PHELLINUS LINTEUS MYCELIUM CAPSULE ORAL 20121229 UNAPPROVED DRUG OTHER Yein Trading & Global Co., Ltd PHELLINUS LINTEUS MYCELIUM 1.1 1/1 53144-2001_46ab2ed2-7798-415d-8b8b-64935e1a35f0 53144-2001 HUMAN OTC DRUG Messima EX PHELLINUS LINTEUS MYCELIUM POWDER ORAL 20121229 UNAPPROVED DRUG OTHER Yein Trading & Global Co., Ltd PHELLINUS LINTEUS MYCELIUM 1.1 g/1.1g 53144-3001_a32e5228-31a4-4d90-aabb-40e177bf72fe 53144-3001 HUMAN OTC DRUG IMG PHELLINUS LINTEUS MYCELIUM TABLET ORAL 20130216 UNAPPROVED DRUG OTHER Yein Trading & Global Co., Ltd PHELLINUS LINTEUS MYCELIUM .022 1/1 53144-4001_c73f23f9-2564-4a47-96c2-d3b63252dd67 53144-4001 HUMAN OTC DRUG Chidangwon 300 LAGERSTROEMIA INDICA WHOLE TABLET ORAL 20130105 UNAPPROVED DRUG OTHER Yein Trading & Global Co., Ltd LAGERSTROEMIA INDICA WHOLE .018 1/1 53145-002_4000c212-7fc1-47b8-a4c0-29fce9835e3d 53145-002 HUMAN OTC DRUG Hielo Ardiente Menthol GEL TOPICAL 20120221 OTC MONOGRAPH NOT FINAL part348 Menper Distributors, Inc. MENTHOL 4840 mg/g 53145-004_b5cbae0b-7809-454d-86fe-225fdcfb2dd0 53145-004 HUMAN OTC DRUG Aseptil Rojo Phenol LIQUID ORAL 20120221 OTC MONOGRAPH NOT FINAL part348 Menper Distributors, Inc. PHENOL 1 mg/mL 53145-005_9e736578-5b03-4142-aaab-f038e4a6d2ad 53145-005 HUMAN OTC DRUG Defensol D Acetaminophen, Chlorpherinamine maleate, Phenylephrine HCI TABLET ORAL 20120221 OTC MONOGRAPH NOT FINAL part343 Menper Distributors, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 53145-006_d11c73cf-1961-4b9c-8e3f-c6e26c0dee15 53145-006 HUMAN OTC DRUG Defensolito Acetaminophen, Phenylephrine Hydrochloride TABLET, CHEWABLE ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 80; 2.5 mg/1; mg/1 53145-007_29b9aebb-404c-4d99-8db1-11b65625c94f 53145-007 HUMAN OTC DRUG Breacold Children Guaifenesin, Dextromethorphan HBR LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/15mL; mg/15mL 53145-008_1bc2e2b0-0502-4b4d-aa62-7594f0b7f9b0 53145-008 HUMAN OTC DRUG Defensolito Children Syrup Guaifenesin, Dextromethorphan HBR LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/15mL; mg/15mL 53145-019_8e4174ab-f00c-4381-be54-0bec5909526c 53145-019 HUMAN OTC DRUG Hongocura Pinceladas Undecylenic Acid LIQUID TOPICAL 20120221 OTC MONOGRAPH FINAL part333C Menper Distributors, Inc. UNDECYLENIC ACID 200 mg/mL 53145-022_837fac56-d098-4c1f-ba33-146f3f235ed1 53145-022 HUMAN OTC DRUG Callicide Corn and Callus Remover Salicylic acid OINTMENT TOPICAL 20120221 OTC MONOGRAPH FINAL part358B Menper Distributors, Inc. SALICYLIC ACID 5 g/g 53145-026_7b0c81cd-8148-4653-8b65-97e4976e5c35 53145-026 HUMAN OTC DRUG Broncofin Broncofin LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 10; 5 mg/5mL; mg/5mL 53145-030_135c2e98-0fa6-472c-b9b3-c867048d7ea0 53145-030 HUMAN OTC DRUG Bronco Pulmonar Syrup Guaifenesin, Dextromethrophan HBR LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 53145-031_c4d0389a-acfc-4fd0-a45b-7e7d90e26da0 53145-031 HUMAN OTC DRUG Pulmovac Guaifenesin, Dextromethorphan HBR LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 53145-032_63464087-a8dd-43b7-b81e-be9e9c8bf1ce 53145-032 HUMAN OTC DRUG Bronkisan Guaifenesin, Dextromethorphan HBR LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 53145-039_f85cebbf-fd88-4733-9c33-169cf8a1cbce 53145-039 HUMAN OTC DRUG Defensol Adult Syrup Guaifenesin, Dextromethorphan HBR LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 53145-040_36d6a815-d6ec-4839-a38a-b45b032c95c7 53145-040 HUMAN OTC DRUG Breacold Adult Guaifenesin, Dextromethorphan HBr LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 53145-047_4fdb91df-9460-4be2-8993-09d13f5786e5 53145-047 HUMAN OTC DRUG La Flecha Japonesa Methyl salicylate OIL TOPICAL 20120221 OTC MONOGRAPH FINAL part348 Menper Distributors, Inc. METHYL SALICYLATE 105 mg/mL 53145-052_d8db724d-0259-45d3-948a-6fe7534bd79d 53145-052 HUMAN OTC DRUG Gesteira Acetaminophen LIQUID ORAL 20120221 OTC MONOGRAPH NOT FINAL part343 Menper Distributors, Inc. ACETAMINOPHEN 675 mg/675mL 53145-053_70fc35ba-e6e8-4602-a03c-89b26d943b03 53145-053 HUMAN OTC DRUG Dolofin Infantil Acetaminophen LIQUID ORAL 20120221 OTC MONOGRAPH NOT FINAL part343 Menper Distributors, Inc. ACETAMINOPHEN 160 mg/5mL 53145-055_dbe747fb-16c7-4426-b1af-e40daec0ccd4 53145-055 HUMAN OTC DRUG Bismutina Bismuth Subsalycilate LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part335 Menper Distributors, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL 53145-056_135d901a-8b0f-4b1a-978d-bf2a5623558b 53145-056 HUMAN OTC DRUG Pomada de Sulfa Neomycin sulfate OINTMENT TOPICAL 20120221 OTC MONOGRAPH FINAL part333B Menper Distributors, Inc. NEOMYCIN SULFATE 3.5 mg/57g 53145-057_1709678e-0432-4fb5-a029-56b43b25b92b 53145-057 HUMAN OTC DRUG Threda Bismuth Subsalycilate LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part335 Menper Distributors, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL 53145-059_5214881e-6a73-4631-af49-cb3f55439a84 53145-059 HUMAN OTC DRUG Cosedal Drops Dextromethorphan HBR, Guaifenesin LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 53145-060_4d97128d-74b9-43ec-b70e-6f73787d5b19 53145-060 HUMAN OTC DRUG Magmex Magnesium hydroxide LIQUID ORAL 20120221 OTC MONOGRAPH NOT FINAL part334 Menper Distributors, Inc. MAGNESIUM HYDROXIDE 1200 mg/15mL 53145-101_65f9fe4a-c479-442a-bfa6-63c2e618f5f2 53145-101 HUMAN OTC DRUG PARASITOL PYRANTEL PAMOATE SUSPENSION ORAL 20130101 OTC MONOGRAPH FINAL part357B Menper Distributors Inc. PYRANTEL PAMOATE 144 mg/mL 53145-119_227c277a-756f-4084-940d-bdaa21b032e1 53145-119 HUMAN OTC DRUG Pinceladas Para Hongos Navarro Undecylenic Acid LIQUID TOPICAL 20120221 OTC MONOGRAPH FINAL part333C Menper Distributors, Inc. UNDECYLENIC ACID 200 mg/mL 53145-219_e3d1f194-2c7c-4a6b-9561-7d5cf1cd38d6 53145-219 HUMAN OTC DRUG Hongocura M Undecylenic Acid LIQUID TOPICAL 20120221 OTC MONOGRAPH FINAL part333C Menper Distributors, Inc. UNDECYLENIC ACID 200 mg/mL 53145-300_23697a99-ce4b-4d28-a939-07846f82f9d7 53145-300 HUMAN OTC DRUG Anti-Empacho Sodium Bicarbonate LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part331 Menper Distributors, Inc. SODIUM BICARBONATE 525 mg/15mL 53145-302_8aaad35b-e249-4928-9825-736a01636679 53145-302 HUMAN OTC DRUG Toa Syrup Adult Toa Syrup Adult LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE 10; 5 mg/5mL; mg/5mL 53145-303_55597310-68c6-4c0d-a03e-06143bc868e0 53145-303 HUMAN OTC DRUG Veneno de Abeja Aceite De Vibora Brand Methyl Salicylate OINTMENT TOPICAL 20110510 OTC MONOGRAPH NOT FINAL part348 Menper Distributors Inc. METHYL SALICYLATE 10.5 g/90g 53145-304_903c6d7b-b183-4220-b095-2dee68f7473e 53145-304 HUMAN OTC DRUG Polvos de Sulpha First Aid Antibiotic Bacitracin Zinc, Polymyxin B Sulfate POWDER TOPICAL 20061211 OTC MONOGRAPH FINAL part333B Menper Distributors Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 1/7.5g; 1/7.5g 53145-308_24ca5876-b7fc-4dd4-88c3-f0c99f2191d3 53145-308 HUMAN OTC DRUG LIENDREX PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE SHAMPOO TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part358G Menper Distributors Inc. PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .3 g/100mL; g/100mL 53145-319_9c47eefb-590a-4073-84e6-9ad91d93fc45 53145-319 HUMAN OTC DRUG Hongocura S Undecylenic Acid LIQUID TOPICAL 20120221 OTC MONOGRAPH FINAL part333C Menper Distributors, Inc. UNDECYLENIC ACID 200 mg/mL 53145-401_98b4948a-5421-4ef1-bc30-280304ea28fc 53145-401 HUMAN OTC DRUG Balsamo de Ubre Mascura Methyl Salicylate OINTMENT TOPICAL 20110510 OTC MONOGRAPH NOT FINAL part348 Menper Distributors Inc. METHYL SALICYLATE 10.5 g/90g 53150-209_87bed912-1bb0-4527-a25e-f4447baf564c 53150-209 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET ORAL 20140430 ANDA ANDA078195 Amneal-Agila, LLC NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 53150-247_fa3e9573-f016-49ed-9ec8-1da4c07274f1 53150-247 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride Epirubicin Hydrochloride INJECTION INTRAVENOUS 20130731 ANDA ANDA091599 Amneal-Agila, LLC EPIRUBICIN HYDROCHLORIDE 200 mg/100mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 53150-250_fa3e9573-f016-49ed-9ec8-1da4c07274f1 53150-250 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride Epirubicin Hydrochloride INJECTION INTRAVENOUS 20130731 ANDA ANDA091599 Amneal-Agila, LLC EPIRUBICIN HYDROCHLORIDE 50 mg/25mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 53150-314_7e9e34a5-0865-4193-aa65-41a7b87821dc 53150-314 HUMAN PRESCRIPTION DRUG DOXOrubicin Hydrochloride DOXOrubicin Hydrochloride INJECTION INTRAVENOUS 20130430 ANDA ANDA200901 Amneal-Agila, LLC DOXORUBICIN HYDROCHLORIDE 20 mg/10mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 53150-315_7e9e34a5-0865-4193-aa65-41a7b87821dc 53150-315 HUMAN PRESCRIPTION DRUG DOXOrubicin Hydrochloride DOXOrubicin Hydrochloride INJECTION INTRAVENOUS 20130430 ANDA ANDA200901 Amneal-Agila, LLC DOXORUBICIN HYDROCHLORIDE 50 mg/25mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 53150-317_7e9e34a5-0865-4193-aa65-41a7b87821dc 53150-317 HUMAN PRESCRIPTION DRUG DOXOrubicin Hydrochloride DOXOrubicin Hydrochloride INJECTION INTRAVENOUS 20130430 ANDA ANDA200901 Amneal-Agila, LLC DOXORUBICIN HYDROCHLORIDE 200 mg/100mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 53150-320_7e9e34a5-0865-4193-aa65-41a7b87821dc 53150-320 HUMAN PRESCRIPTION DRUG DOXOrubicin Hydrochloride DOXOrubicin Hydrochloride INJECTION INTRAVENOUS 20130430 ANDA ANDA200901 Amneal-Agila, LLC DOXORUBICIN HYDROCHLORIDE 10 mg/5mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 53150-336_176934bd-fd14-4485-bc73-ae43b4942b5b 53150-336 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride Idarubicin Hydrochloride INJECTION INTRAVENOUS 20130430 ANDA ANDA200144 Amneal-Agila, LLC IDARUBICIN HYDROCHLORIDE 5 mg/5mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 53150-386_176934bd-fd14-4485-bc73-ae43b4942b5b 53150-386 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride Idarubicin Hydrochloride INJECTION INTRAVENOUS 20130430 ANDA ANDA200144 Amneal-Agila, LLC IDARUBICIN HYDROCHLORIDE 10 mg/10mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 53150-411_176934bd-fd14-4485-bc73-ae43b4942b5b 53150-411 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride Idarubicin Hydrochloride INJECTION INTRAVENOUS 20130430 ANDA ANDA200144 Amneal-Agila, LLC IDARUBICIN HYDROCHLORIDE 20 mg/20mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 53150-415_539951c7-0516-4970-86db-84fe6b95d813 53150-415 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20130423 ANDA ANDA075440 Amneal-Agila, LLC HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] 53150-422_539951c7-0516-4970-86db-84fe6b95d813 53150-422 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20130423 ANDA ANDA075440 Amneal-Agila, LLC HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] 53150-485_539951c7-0516-4970-86db-84fe6b95d813 53150-485 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20130423 ANDA ANDA075440 Amneal-Agila, LLC HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] 53150-489_539951c7-0516-4970-86db-84fe6b95d813 53150-489 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20130423 ANDA ANDA075440 Amneal-Agila, LLC HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] 53150-697_d94a88ed-96a4-41ee-84fb-9514c0987b85 53150-697 HUMAN PRESCRIPTION DRUG Calcium Chloride Calcium Chloride INJECTION INTRAVENOUS 20130531 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Amneal-Agila, LLC CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 53150-871_d4595229-52b1-4ddb-8fcf-d9422406ca43 53150-871 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20120423 ANDA ANDA202650 Amneal-Agila, LLC ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 53152-1004_5f6fcb2b-aa3b-47bb-b6e1-c82ba6779676 53152-1004 HUMAN OTC DRUG Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120828 OTC MONOGRAPH NOT FINAL part333E AOSS Medical Supply, Inc. ALCOHOL 62 mL/100mL 53152-1008_8215e149-2384-4ce8-9d87-50763df93da8 53152-1008 HUMAN OTC DRUG Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120828 OTC MONOGRAPH NOT FINAL part333E AOSS Medical Supply, Inc. ALCOHOL 62 mL/100mL 53157-100_25edc224-0331-45f2-842d-cc2b9514a9da 53157-100 HUMAN PRESCRIPTION DRUG Nutricel Additive Solution - CP2D CP2D/AS-3 Anticoagulant and Additive System SOLUTION INTRAVENOUS 20130913 NDA BN820915 Haemonetics Manufacturing Inc. DEXTROSE 3.57 g/70mL 53157-101_25edc224-0331-45f2-842d-cc2b9514a9da 53157-101 HUMAN PRESCRIPTION DRUG Nutricel Additive Solution - AS-3 CP2D/AS-3 Anticoagulant and Additive System SOLUTION INTRAVENOUS 20130913 NDA BN820915 Haemonetics Manufacturing Inc. ADENINE; DEXTROSE .033; 1.21 g/110mL; g/110mL 53157-120_d04e21af-becf-4048-b53c-e03393a6a870 53157-120 HUMAN PRESCRIPTION DRUG Nutricel Additive System - CP2D CP2D/AS-3 Anticoagulant and Additive System SOLUTION INTRAVENOUS 20130805 NDA NDA820915 Haemonetics Manufacturing Inc DEXTROSE 3.57 g/70mL 53157-121_c8fb1eb3-9361-47bd-a62f-16ef2da78607 53157-121 HUMAN PRESCRIPTION DRUG Nutricel Additive Solution - CP2D CP2D/AS-3 Anticoagulant and Additive System SOLUTION INTRAVENOUS 20130821 NDA NDA820915 Haemonetics Manufacturing Inc. DEXTROSE 3.57 g/70mL 53157-122_c8fb1eb3-9361-47bd-a62f-16ef2da78607 53157-122 HUMAN PRESCRIPTION DRUG Nutricel Additive Solution - AS-3 CP2D/AS-3 Anticoagulant and Additive System SOLUTION INTRAVENOUS 20130821 NDA NDA820915 Haemonetics Manufacturing Inc. ADENINE; DEXTROSE .033; 1.21 g/110mL; g/110mL 53157-123_1fe72177-6c12-4e3f-8895-b9d3ba994d9b 53157-123 HUMAN PRESCRIPTION DRUG Leukotrap - CP2D Solution Anticoagulant Citrate Phosphate Double Dextrose SOLUTION INTRAVENOUS 19831109 NDA NDA820915 Haemonetics Manufacturing Inc DEXTROSE 3.57 g/70mL 53157-124_1fe72177-6c12-4e3f-8895-b9d3ba994d9b 53157-124 HUMAN PRESCRIPTION DRUG Leukotrap - AS-3 Solution Additive Solution - 3 SOLUTION INTRAVENOUS 19831109 NDA NDA820915 Haemonetics Manufacturing Inc ADENINE; DEXTROSE .033; 1.21 g/110mL; g/110mL 53157-129_028e6f14-34f2-49f4-99a5-83c457d4e96f 53157-129 HUMAN PRESCRIPTION DRUG Leukotrap Blood Collection System KIT 19830922 NDA NDA820915 Haemonetics Manufacturing Inc 53157-130_145f874d-bba2-42b7-a7f5-63c43bce506e 53157-130 HUMAN PRESCRIPTION DRUG CPDA-1 Blood Collection System Blood Collection System SOLUTION INTRAVENOUS 19801106 NDA NDA800077 Haemonetics Manufacturing Inc ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .019; .229; 2.23; 1.84; .155 g/70mL; g/70mL; g/70mL; g/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] CII 53157-136_b47462f0-b43f-470f-a3f7-4ce17a14a769 53157-136 HUMAN PRESCRIPTION DRUG Leukotrap WB System CPDA-1 Blood Bag Collection System SOLUTION INTRAVENOUS 19801106 NDA NDA800077 Haemonetics Manufacturing Inc ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .019; .229; 2.23; 1.84; .155 g/70mL; g/70mL; g/70mL; g/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] CII 53157-136_cd05ee40-f7de-4d1b-b701-648ff2dfdb3e 53157-136 HUMAN PRESCRIPTION DRUG Leukotrap WB System CPDA-1 Blood Bag Collection System SOLUTION INTRAVENOUS 19801106 NDA NDA800077 Haemonetics Manufacturing Inc ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .019; .229; 2.23; 1.84; .155 g/70mL; g/70mL; g/70mL; g/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] CII 53157-136_fdd00e7b-039a-48a8-b654-941f85f5c00f 53157-136 HUMAN PRESCRIPTION DRUG Leukotrap WB System CPDA-1 Blood Bag Collection System SOLUTION INTRAVENOUS 19801106 NDA NDA800077 Haemonetics Manufacturing Inc ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .019; .229; 2.23; 1.84; .155 g/70mL; g/70mL; g/70mL; g/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] CII 53157-300_795f1082-9ede-47cb-9a22-5092787ecbb3 53157-300 HUMAN PRESCRIPTION DRUG LEUKOSEP - CPD Solution Citrate Phosphate Dextrose (CPD) Solution SOLUTION INTRAVENOUS 20130515 NDA NDA110059 Haemonetics Manufacturing Inc DEXTROSE 1.78 g/70mL 53157-301_795f1082-9ede-47cb-9a22-5092787ecbb3 53157-301 HUMAN PRESCRIPTION DRUG LEUKOSEP - SOLX B ADDITIVE SOLUTION SOLX B ADDITIVE SOLUTION SOLUTION INTRAVENOUS 20130515 NDA NDA110059 Haemonetics Manufacturing Inc DEXTROSE 1.78 g/30mL 53157-303_795f1082-9ede-47cb-9a22-5092787ecbb3 53157-303 HUMAN PRESCRIPTION DRUG LEUKOSEP - SOLX A ADDITIVE SOLUTION SOL A ADDITIVE SOLUTION SOLUTION INTRAVENOUS 20130515 NDA NDA110059 Haemonetics Manufacturing Inc ADENINE; MANNITOL 30; 1.1 mg/80mL; g/80mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 53157-730_949abd84-24b2-4e38-8640-12073408d46b 53157-730 HUMAN PRESCRIPTION DRUG CPDA-1 Blood Collection System Blood Collection System SOLUTION INTRAVENOUS 19801106 NDA NDA800077 Haemonetics Manufacturing Inc ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .017; .206; 2.01; 1.66; .14 g/63mL; g/63mL; g/63mL; g/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] CII 53157-736_744a75d7-c324-4999-80c6-50612d067835 53157-736 HUMAN PRESCRIPTION DRUG Leukotrap WB System CPDA-1 Blood Bag Collection System SOLUTION INTRAVENOUS 19801106 NDA NDA800077 Haemonetics Manufacturing Inc ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .017; .206; 2.01; 1.66; .14 g/63mL; g/63mL; g/63mL; g/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] CII 53157-736_b2064cb0-542d-41d4-82ef-e7e6a53b9400 53157-736 HUMAN PRESCRIPTION DRUG Leukotrap WB System CPDA-1 Blood Bag Collection System SOLUTION INTRAVENOUS 19801106 NDA NDA800077 Haemonetics Manufacturing Inc ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .017; .206; 2.01; 1.66; .14 g/63mL; g/63mL; g/63mL; g/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] CII 53157-AS3_d04e21af-becf-4048-b53c-e03393a6a870 53157-AS3 HUMAN PRESCRIPTION DRUG Nutricel Additive System - AS3 CP2D/AS-3 Anticoagulant and Additive System SOLUTION INTRAVENOUS 20130805 NDA NDA820915 Haemonetics Manufacturing Inc ADENINE; DEXTROSE .033; 1.21 g/110mL; g/110mL 53163-101_e5d7a636-0d7e-46a6-baa1-149e464360ae 53163-101 HUMAN OTC DRUG Altipres-B BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20121101 OTC MONOGRAPH FINAL part341 Alternative Pharmacal Corporation BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 20; 10 mg/5mL; mg/5mL; mg/5mL 53163-103_1481c32e-8a0f-4de0-a26e-bb40876a6068 53163-103 HUMAN OTC DRUG Altipres Pediatric Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20130501 OTC MONOGRAPH FINAL part341 Alternative Pharmacal Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 75; 2.5 mg/5mL; mg/5mL; mg/5mL 53163-104_36243788-6b37-48b1-b7ce-8db89ac3ccce 53163-104 HUMAN OTC DRUG Altipres Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20130501 OTC MONOGRAPH FINAL part341 Alternative Pharmacal Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL 53163-106_a8d5f774-c8ba-44b8-a73d-9f109a378d60 53163-106 HUMAN OTC DRUG Igualtuss Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20140301 OTC MONOGRAPH FINAL part341 Alternative Pharmacal Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 28; 388; 10 mg/5mL; mg/5mL; mg/5mL 53163-251_a99931b2-8fe8-451d-8151-937201cce40e 53163-251 HUMAN OTC DRUG Altidome DMX Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20131101 OTC MONOGRAPH FINAL part341 Alternative Pharmacal Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 30; 200; 10 mg/5mL; mg/5mL; mg/5mL 53174-000_ae1342c1-5896-4218-8965-f2b2c46877d9 53174-000 HUMAN OTC DRUG Army Health Pain Reliever MENTHOL GEL TOPICAL 20120824 OTC MONOGRAPH NOT FINAL part348 Cas Group International MENTHOL 3 mL/100mL 53175-001_e2956310-eee1-43c3-8016-007e40b50b15 53175-001 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20120910 OTC MONOGRAPH NOT FINAL part356 Dyad Medical Sourcing, LLC HYDROGEN PEROXIDE 3 mL/100mL 53185-001_c3475692-c3be-44e6-bda3-8e9c7afb88c5 53185-001 HUMAN OTC DRUG Clear Choice Allergy Relief CHLORPHENIRAMINE MALEATE TABLET ORAL 20120823 OTC MONOGRAPH FINAL part341 Athlete's Needs Inc CHLORPHENIRAMINE MALEATE 4 mg/1 53185-002_aeb6fab7-22bf-45d8-9617-bd3089001891 53185-002 HUMAN OTC DRUG Extra Strength Pain Reliever ACETAMINOPHEN TABLET ORAL 20120913 OTC MONOGRAPH NOT FINAL part343 Athlete's Needs Inc ACETAMINOPHEN 500 mg/1 53185-003_31ab6ec9-33a6-465c-a512-d5c45b353705 53185-003 HUMAN OTC DRUG Clear Choice Ibuprofen IBUPROFEN TABLET ORAL 20121009 ANDA ANDA079129 Athlete's Needs Inc IBUPROFEN 200 mg/1 53185-004_b132a177-4796-42aa-8de7-263549baf33e 53185-004 HUMAN OTC DRUG Modern Pain Medicine Naproxen Sodium TABLET ORAL 20130506 ANDA ANDA079096 Athlete's Needs Inc NAPROXEN SODIUM 220 mg/1 53185-005_bee17e96-0a25-44cb-9006-bfff1e02af05 53185-005 HUMAN OTC DRUG Regular Strength Pain Reliever ACETAMINOPHEN TABLET ORAL 20130603 OTC MONOGRAPH NOT FINAL part343 Athlete's Needs Inc ACETAMINOPHEN 325 mg/1 53187-129_08e45495-a0c1-4587-8bbd-f4232bc8c7f0 53187-129 HUMAN OTC DRUG All Day Allergy Cetirizine HCl TABLET ORAL 20111123 ANDA ANDA078780 LIVE BETTER (The Great Atlantic & Pacific Tea Company) CETIRIZINE HYDROCHLORIDE 10 mg/1 53187-189_30bdf288-c933-4867-9929-ef702c97ef9d 53187-189 HUMAN OTC DRUG 24 Hour Allergy Fexofenadine HCl TABLET ORAL 20130320 ANDA ANDA079112 LIVE BETTER (The Great Atlantic & Pacific Tea Company) FEXOFENADINE HYDROCHLORIDE 180 mg/1 53187-199_5ddba052-b2f4-4556-8fe0-921505d75085 53187-199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130325 ANDA ANDA078682 LIVE BETTER (The Great Atlantic & Pacific Tea Company) IBUPROFEN 200 mg/1 53187-220_521a2311-5b96-443e-aef1-b2f406eafb6b 53187-220 HUMAN OTC DRUG All Day Allergy Cetirizine HCl TABLET ORAL 20130607 ANDA ANDA078427 LIVE BETTER (The Great Atlantic & Pacific Tea Company) CETIRIZINE HYDROCHLORIDE 10 mg/1 53187-230_4c68aa12-2dc2-45f2-b731-6bee6d0d0e16 53187-230 HUMAN OTC DRUG Nighttime Sleep Aid maximum strength Diphenhydramine HCl CAPSULE ORAL 20100726 OTC MONOGRAPH FINAL part341 LIVE BETTER (The Great Atlantic & Pacific Tea Company) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 53187-236_20e2cdca-40e8-473c-a652-1227111e4c38 53187-236 HUMAN OTC DRUG NightTime Sleep Aid Maximum Strength DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 LIVE BETTER (The Great Atlantic & Pacific Tea Company) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 53187-238_0f74d5fe-ae47-433c-a5cf-c94b18c0954e 53187-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130830 OTC MONOGRAPH NOT FINAL part334 LIVE BETTER (The Great Atlantic & Pacific Tea Company) DOCUSATE SODIUM 100 mg/1 53187-242_bea2b147-b851-4c6d-b80f-28713e8070c7 53187-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH FINAL part347 LIVE BETTER (The Great Atlantic & Pacific Tea Company) DIMETHICONE 125 mg/1 53187-470_fb4c9976-2fb2-4b6b-a350-f4ea77ec4d22 53187-470 HUMAN OTC DRUG Daytime Cold and Flu relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130105 OTC MONOGRAPH FINAL part341 LIVE BETTER (The Great Atlantic & Pacific Tea Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 53187-480_27302234-335b-4e72-9dbc-9d4f814ddb40 53187-480 HUMAN OTC DRUG Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130531 OTC MONOGRAPH FINAL part341 LIVE BETTER (The Great Atlantic & Pacific Tea Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 53187-530_dcff1462-4615-46d6-9e32-b632b3679f6a 53187-530 HUMAN OTC DRUG Gas Relief ultra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20100817 OTC MONOGRAPH FINAL part332 LIVE BETTER (The Great Atlantic & Pacific Tea Company) DIMETHICONE 180 mg/1 53187-670_1e41cac5-2593-45a6-af3c-b69a61e2f15a 53187-670 HUMAN OTC DRUG Nasal Decongestant Maximum Strength Phenylephrine HCl TABLET ORAL 20140331 OTC MONOGRAPH FINAL part341 LIVE BETTER (The Great Atlantic & Pacific Tea Company) PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 53199-100_d2f06fc5-8eb1-4399-bc2c-4fb42f6accfb 53199-100 HUMAN PRESCRIPTION DRUG Southern Medical Oxygen, Compressed Compressed Oxygen GAS RESPIRATORY (INHALATION) 20100108 UNAPPROVED MEDICAL GAS Michael R. Mullins II Inc. dba Southern Medical OXYGEN 1 L/L 53200-001_a5d9e551-6401-4b22-b7fc-92031b40c295 53200-001 HUMAN PRESCRIPTION DRUG Derma Numb Lidocaine HCI SPRAY TOPICAL 20120715 OTC MONOGRAPH FINAL part348 Atlas Tat Inc. LIDOCAINE HYDROCHLORIDE 40 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 53200-001_e28834f3-99dc-40a7-9e11-d71d0dc7d317 53200-001 HUMAN OTC DRUG Derma Numb Lidocaine SPRAY TOPICAL 20120715 OTC MONOGRAPH FINAL part348 Atlas Tat Inc. LIDOCAINE 40 mg/g 53200-005_2b893b24-c1b5-41b3-9950-c09a94bd9848 53200-005 HUMAN OTC DRUG Derma Numb Lidocaine SPRAY TOPICAL 20140806 OTC MONOGRAPH NOT FINAL part348 Atlas Tat Inc. LIDOCAINE 50 mg/g 53203-101_0aafc926-a871-4a89-b952-ee6fdba2bc1f 53203-101 HUMAN OTC DRUG HERBAL HEAT PAIN RELIEVING PATCH PATCH TOPICAL 20130131 OTC MONOGRAPH NOT FINAL part348 Eu Yan Sang (USA) Inc CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 1; 6; 2 g/100g; g/100g; g/100g 53208-000_b39ede82-ced3-4e75-bde2-79d955e78ba6 53208-000 HUMAN OTC DRUG ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PA TITANIUM DIOXIDE CREAM TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TITANIUM DIOXIDE 121.6 mg/g 53208-001_cedd69f6-2cce-4882-b321-30ada48c349b 53208-001 HUMAN OTC DRUG O HUI Sun Science Ideal Cover Sunscreen Broad Spectrum TITANIUM DIOXIDE CREAM TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TITANIUM DIOXIDE 121.6 mg/g 53208-002_806de4eb-c7aa-43b8-91a6-315b1bb73b5a 53208-002 HUMAN OTC DRUG ISA KNOX 365 SUNSCREEN BROAD SPECTRUM SPF 50 Plus HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20141028 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 26 mg/mL; mg/mL; mg/mL; mg/mL 53208-372_19e255cc-cf02-465b-9b81-d08787c21ab8 53208-372 HUMAN OTC DRUG GONGJINHYANG SEOL WHITENING DIOSMETIN CREAM TOPICAL 20100324 OTC MONOGRAPH NOT FINAL part358 LG Household and Healthcare, Inc. DIOSMETIN .1 g/100g 53208-374_447ddb2a-e161-48b5-a894-48e49790d982 53208-374 HUMAN OTC DRUG Gongjinhyang Seol Whitening Intensive DIACETYL BENZOYL LATHYROL CREAM TOPICAL 20100326 OTC MONOGRAPH NOT FINAL part358 LG Household and Healthcare, Inc. DIACETYL BENZOYL LATHYROL .1 mL/100mL 53208-377_faa27470-f1a4-461b-b2ae-4ae04a2f271a 53208-377 HUMAN OTC DRUG GONGJINHYANG SEOL WHITENING JINAEK PROGRAM DIACETYL BENZOYL LATHYROL CREAM TOPICAL 20100329 OTC MONOGRAPH NOT FINAL part358 LG Household and Healthcare, Inc. DIACETYL BENZOYL LATHYROL .1 mL/100mL 53208-385_33a6f73b-4cc8-407a-8cf1-f07403a3284a 53208-385 HUMAN OTC DRUG ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION ARBUTIN LOTION TOPICAL 20100329 OTC MONOGRAPH NOT FINAL part358 LG Household and Healthcare, Inc. ARBUTIN 2.1 g/100g 53208-393_64ed9efb-7b75-44e8-bbd2-b44e6e078194 53208-393 HUMAN OTC DRUG ISAKNOX SUNCARE 365 ADVANCED SUN ZINC OXIDE, OCTINOXATE, SULFURIC ACID CREAM TOPICAL 20100330 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 1; 11 mL/100mL; mL/100mL; mL/100mL 53208-410_24c090dd-d82e-4659-b823-0392e3aac691 53208-410 HUMAN OTC DRUG GONGJINHYANG MI LUXURY FOUNDATION 2 OCTINOXATE, HYDROXYPROLINE CREAM TOPICAL 20100330 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. HYDROXYPROLINE; OCTINOXATE .53; 1 mL/100mL; mL/100mL 53208-414_eb468f28-0e53-4414-b5a2-565b9063b5a8 53208-414 HUMAN OTC DRUG ISA KNOX WHITE SYMPHONY AMPULE ESSENCE ATRACTYLODES JAPONICA ROOT CREAM TOPICAL 20100524 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. ATRACTYLODES JAPONICA ROOT .0525 mL/100mL 53208-418_cae59fd9-dd1f-42e9-bf32-b65731cb932b 53208-418 HUMAN OTC DRUG Sooryehan Dabityoon Jiyoon Two way cake 23 Titanium Dioxide, OCTINOXATE POWDER TOPICAL 20100330 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; TITANIUM DIOXIDE 3.5; 14 g/100g; g/100g 53208-424_6e64ea12-51fb-48c5-ac2f-90142bf2ba20 53208-424 HUMAN OTC DRUG ISA KNOX WXII PLUS WHITENING REVOLUTION SERUM DIOSMETIN CREAM TOPICAL 20100423 OTC MONOGRAPH NOT FINAL part358 LG Household and Healthcare, Inc. DIOSMETIN .11 mL/100mL 53208-427_e282a217-b834-497f-9c47-2da287e024b9 53208-427 HUMAN OTC DRUG Whoo Gongjinhyang Seol Whitening Jin Essence DIOSMETIN CREAM TOPICAL 20100524 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. DIOSMETIN .055 mL/100mL 53208-428_65b4e93e-d520-4a32-a8a2-578c80a98349 53208-428 HUMAN OTC DRUG WHOO GONGJINHYANG SEOL WHITENING JINAEK PROGRAM KIT TITANIUM DIOXIDE CREAM TOPICAL 20100414 OTC MONOGRAPH NOT FINAL part358 LG Household and Healthcare, Inc. TITANIUM DIOXIDE .5 mL/100mL 53208-429_491d528b-81e8-4510-9d7a-92036789b2c3 53208-429 HUMAN OTC DRUG OHUI Wrinkle Science wrinkle repair eye HYDROXYPROLINE CREAM TOPICAL 20100416 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. HYDROXYPROLINE .51 1/100mL 53208-430_df8ba716-4e38-451b-b6ae-b87cb8c070fd 53208-430 HUMAN OTC DRUG O HUI WRINKLE SCIENCE WRINKLE REPAIR HYDROXYPROLINE CREAM TOPICAL 20100416 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. HYDROXYPROLINE .5 1/100mL 53208-437_91fec625-4ddf-4570-8190-f75d77d1ea02 53208-437 HUMAN OTC DRUG OHUI Sun Science Powder Sun Block Natural Skin OCTINOXATE, Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20100416 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. BISOCTRIZOLE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2; 7; 2.5; 5 g/100g; g/100g; g/100g; g/100g 53208-441_9501a469-2860-4638-8c61-9b05d75ba853 53208-441 HUMAN OTC DRUG Sooryehan Pure-Whitening Polydatin CREAM TOPICAL 20100426 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. POLYDATIN .22 mL/100mL 53208-442_96b56a25-5672-4dab-b4dd-41043268fc97 53208-442 HUMAN OTC DRUG Sooryehan Pure-Whitening Essence POLYDATIN CREAM TOPICAL 20100514 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. POLYDATIN .22 1/100mL 53208-444_3f1a7eb9-ed5c-433c-89f1-2b44cd73866a 53208-444 HUMAN OTC DRUG Sooryehan Pure Whitening Spot Treatment POLYDATIN CREAM TOPICAL 20100426 OTC MONOGRAPH NOT FINAL part358 LG Household and Healthcare, Inc. POLYDATIN .21 mL/100mL 53208-445_5aa029cd-c6b4-422c-a8af-8b912a261df0 53208-445 HUMAN OTC DRUG Sooryehan Pure-Whitening Essential Starter ARBUTIN CREAM TOPICAL 20100428 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. ARBUTIN 2.1 mL/100mL 53208-446_21977c7e-dbed-4069-aee8-8ef54f827924 53208-446 HUMAN OTC DRUG Sooryehan Jadan Sun Mild OCTOCRYLENE, ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part358 LG Household and Healthcare, Inc. OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 7; 2; 2; 5.612 mL/100mL; 1/100mL; mL/100mL; mL/100mL 53208-447_5d964551-bd46-42da-be85-faeaa6c1ad8c 53208-447 HUMAN OTC DRUG Sooryehan Bichaek Jadan Sun ZINC OXIDE, TITANIUM DIOXIDE, PHENYLBENZIMIDAZOLE SULFONIC ACID CREAM TOPICAL 20100524 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ENSULIZOLE; TITANIUM DIOXIDE; ZINC OXIDE 3.9; 4.32; 12.88 mL/100mL; mL/100mL; 1/100mL 53208-448_953a9f75-39fb-4fa2-8ca0-81324ebbbfb9 53208-448 HUMAN OTC DRUG Perioe lucky fresh - cavity care Sodium Monofluorophosphate, Pyridoxine Hydrochloride, Calcium Glycerophosphate PASTE DENTAL 20100426 OTC MONOGRAPH NOT FINAL part355 LG Household and Healthcare, Inc. CALCIUM GLYCEROPHOSPHATE; PYRIDOXINE HYDROCHLORIDE; SODIUM MONOFLUOROPHOSPHATE .13; .03; .76 g/100g; g/100g; g/100g 53208-449_d6f74226-da81-4754-9664-c2375b8cda1f 53208-449 HUMAN OTC DRUG Perioe lucky fresh - breath care Sodium Monofluorophosphate, Calcium Glycerophosphate PASTE DENTAL 20100428 OTC MONOGRAPH NOT FINAL part355 LG Household and Healthcare, Inc. CALCIUM GLYCEROPHOSPHATE; SODIUM MONOFLUOROPHOSPHATE .13; .76 g/100g; g/100g 53208-452_3f7ab5b9-1059-4c3d-88c2-303d093a6e67 53208-452 HUMAN OTC DRUG THE HISTORY OF WHOO GONG JIN HYANG HAE YOON SUN OCTINOXATE, BEMOTRIZINOL CREAM TOPICAL 20100430 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. BEMOTRIZINOL; OCTINOXATE .8; 7 mL/100mL; mL/100mL 53208-459_08d50681-3c1a-4537-8478-60dae3839931 53208-459 HUMAN OTC DRUG BAMBOO SALT Eunganggo Jook Yeom Toothpaste SILICON DIOXIDE , SODIUM FLUORIDE, AMINOCAPROIC ACID, GLYCYRRHIZINATE DIPOTASSIUM, Curcuma xanthorrhiza oil, SEA SALT PASTE DENTAL 20100525 OTC MONOGRAPH NOT FINAL part355 LG Household and Healthcare, Inc. AMINOCAPROIC ACID; CURCUMA XANTHORRHIZA OIL; GLYCYRRHIZINATE DIPOTASSIUM; SEA SALT; SILICON DIOXIDE; SODIUM FLUORIDE; URSODIOL .05; .025; .04; 3; 20; .22; .02 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 53208-460_1a793cd5-c190-496c-b960-68ede4d8bb46 53208-460 HUMAN OTC DRUG Gongjinhyang Qi and Jin Eye ANGELICA DAHURICA ROOT CREAM TOPICAL 20100524 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. ANGELICA DAHURICA ROOT .022 mL/100mL 53208-471_89bc51f1-b63c-4058-b0e4-65cdec67f4a0 53208-471 HUMAN OTC DRUG ISA KNOX AGELESS SERUM MAKEUP BASE 10 OCTINOXATE, TITANIUM DIOXIDE, DIMETHICONE, ALUMINUM HYDROXIDE, STEARIC ACID, HYDROXYPROLINE, CREAM TOPICAL 20100704 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ALUMINUM HYDROXIDE; DIMETHICONE; HYDROXYPROLINE; OCTINOXATE; STEARIC ACID; TITANIUM DIOXIDE .18; .08; .53; 3; .18; 3.38 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 53208-473_65e4ff81-62b4-42c6-98d9-76ff1d742cf4 53208-473 HUMAN OTC DRUG OHUI Sun Science intensive sunblock cake EX ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, BEMOTRIZINOL CREAM TOPICAL 20100716 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. BEMOTRIZINOL; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 7; 4; 10.528 g/100g; g/100g; g/100g; g/100g 53208-475_67a7c69f-83e8-4e31-a1a2-a310de75dac4 53208-475 HUMAN OTC DRUG ISAKNOX AGELESS SERUM BLEMISH BALM TITANIUM DIOXIDE, OCTYLTRIETHOXYSILANE, ALUMINUM HYDROXIDE, OCTINOXATE, ATRACTYLOIDES JAPONICA ROOT OIL CREAM TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ALUMINUM HYDROXIDE; ATRACTYLODES JAPONICA ROOT; OCTINOXATE; OCTYLTRIETHOXYSILANE; TITANIUM DIOXIDE .12; .05; 5; .12; 5.76 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 53208-478_032aedf3-c7a9-40aa-8575-4c31c0d515f9 53208-478 HUMAN OTC DRUG ISAKNOX AGELESS SERUM MOIST PEARL BASE OCTINOXATE, TITANIUM DIOXIDE, DIMETHICONE, ALUMINUM HYDROXIDE, STEARIC ACID, HYDROXYPROLINE, LIQUID TOPICAL 20100831 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ALUMINUM HYDROXIDE; DIMETHICONE; HYDROXYPROLINE; OCTINOXATE; STEARIC ACID; TITANIUM DIOXIDE .18; .08; .53; 3; .18; 3.38 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 53208-480_9fdaef16-0160-44b9-b7f2-4a84d6e1736b 53208-480 HUMAN OTC DRUG ISAKNOX AGELESS SERUM COMPACT 23 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; TITANIUM DIOXIDE 2; 4.9 g/100g; g/100g 53208-491_3810c629-0d1c-4fdc-8b3e-8a59e779a029 53208-491 HUMAN OTC DRUG OUHI CELL POWER NO 1 ESSENCE NIACINAMIDE, HYDROXYPROLINE LIQUID TOPICAL 20101203 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. HYDROXYPROLINE; NIACINAMIDE .5; 2 mL/100mL; mL/100mL 53208-494_c31af57f-062b-4c43-a574-3bf1dd02f48e 53208-494 HUMAN OTC DRUG OHUI SUN SCIENCE PERFECT SUNBLOCK RED EX ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20100716 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 13.34 mL/100mL; mL/100mL 53208-500_73e50476-5db8-4a12-9a76-47e0d5b9caa8 53208-500 HUMAN OTC DRUG Gongjinhyang Qi and Jin Eye .GAMMA.-AMINOBUTYRIC ACID CREAM TOPICAL 20100524 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. .GAMMA.-AMINOBUTYRIC ACID .022 mL/100mL 53208-501_a9487cb0-296c-4e6b-bf00-8fa582917adf 53208-501 HUMAN OTC DRUG O HUI WHITE EXTREME CELLIGHT PROTOCATECHUALDEHYDE EMULSION TOPICAL 20110307 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. PROTOCATECHUALDEHYDE .0315 mL/100mL 53208-502_2bda68ca-7ba8-45b6-807f-e1d4d22f1f50 53208-502 HUMAN OTC DRUG ISA KNOX 365 SUN ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20100330 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.2; 4.03; 11.04 mL/100mL; mL/100mL; mL/100mL 53208-503_00ee8934-f667-44e3-b805-ceaf9f258908 53208-503 HUMAN OTC DRUG The History of Whoo Jin Hae Yoon Sun OCTINOXATE, TITANIUM DIOXIDE, AMILOXATE, BEMOTRIZINOL, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, ENSULIZOLE CREAM TOPICAL 20110316 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. AMILOXATE; BEMOTRIZINOL; DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE; OCTINOXATE; TITANIUM DIOXIDE 1.6; 1; 1; 7; 2.58 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 53208-504_e5e7bab2-698d-413d-b93e-33cc39d5872a 53208-504 HUMAN OTC DRUG GONGJINHYANG SEOL WHITENING ATRACTYLODES JAPONICA ROOT OIL CREAM TOPICAL 20110315 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. ATRACTYLODES JAPONICA ROOT OIL .05 mL/100mL 53208-505_4c084d2d-f59d-44d8-8e61-987001b63633 53208-505 HUMAN OTC DRUG BAMBOO SALT Eunganggo Jook Yeom SILICON DIOXIDE , SODIUM FLUORIDE, AMINOCAPROIC ACID, GLYCYRRHIZINATE DIPOTASSIUM, Curcuma xanthorrhiza oil, SEA SALT PASTE DENTAL 20110315 OTC MONOGRAPH NOT FINAL part355 LG Household and Healthcare, Inc. AMINOCAPROIC ACID; CURCUMA XANTHORRHIZA OIL; GLYCYRRHIZINATE DIPOTASSIUM; SEA SALT; SILICON DIOXIDE; SODIUM FLUORIDE; URSODIOL .05; .025; .04; 3; 20; .22; .02 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 53208-507_a9d5e1c7-8dfe-45c1-97cb-26b8a34bbcd3 53208-507 HUMAN OTC DRUG O HUI WHITE EXTREME CELLIGHT PROTOCATECHUALDEHYDE CREAM TOPICAL 20110316 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. PROTOCATECHUALDEHYDE .032 mL/100mL 53208-513_cf8060a0-432c-488a-b0b5-6d2336421c37 53208-513 HUMAN OTC DRUG Whoo Gong Jin Hyang Jin Hae Yoon Sun BISOCTRIZOLE, OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE POWDER TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. BISOCTRIZOLE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.125; 7.2; 2.125; 4.8 g/100g; g/100g; g/100g; g/100g 53208-515_2b38f356-c9a4-4ebc-9034-bc6de1f11edc 53208-515 HUMAN OTC DRUG OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE CREAM TOPICAL 20110406 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE; ENSULIZOLE; HYDROXYPROLINE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .5; 3.9; .5; 7; 4.8; 6 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 53208-516_10794c21-542e-479a-8266-64cdae9dc30d 53208-516 HUMAN OTC DRUG ReEn Hairloss Clinic Jahajin Shampoo for Sensitive Scalp PYRITHIONE ZINC, PANTHENOL, NIACINAMIDE LIQUID TOPICAL 20110402 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. NIACINAMIDE; PANTHENOL; PYRITHIONE ZINC .1; .2; 1 mL/100mL; mL/100mL; mL/100mL 53208-518_2c7b1f69-5b49-44a9-90a8-0f3552e75c32 53208-518 HUMAN OTC DRUG OHUI SUNSCIENCE LUMINOUS WHITENING SUNBLOCK ENSULIZOLE, OCTISALATE, BEMOTRIZINOL, OCTOCRYLENE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, ZINC OXIDE, TITANIUM DIOXIDE, ATRACTYLODES JAPONICA ROOT OIL CREAM TOPICAL 20110406 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ATRACTYLODES JAPONICA ROOT OIL; BEMOTRIZINOL; DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE .525; 1.5; 1; 3.9; 4.7; 5; 3.67; 12.3 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 53208-519_2001a873-4b20-40b8-9227-38ae7e483bd8 53208-519 HUMAN OTC DRUG ISA KNOX AGELESS MOIST SERUM TWO WAY CAKE 21 (REFILL) TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20110412 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; TITANIUM DIOXIDE 4; 13.38 g/100g; g/100g 53208-520_216c9add-5ee7-494d-b2d2-00bf91e66cc5 53208-520 HUMAN OTC DRUG ISA KNOX SMART BB SUN OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL CREAM TOPICAL 20110412 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ATRACTYLODES JAPONICA ROOT OIL; HYDROXYPROLINE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .5; 7; 6.72; 2.88 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 53208-521_12c77838-1965-4074-aa22-f255bfc8aec4 53208-521 HUMAN OTC DRUG ISA KNOX AGELESS MOIST SERUM TWO WAY CAKE 23 (REFILL) TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20110414 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; TITANIUM DIOXIDE 4; 13.38 g/100g; g/100g 53208-524_ac4cc8c4-fa77-431c-b13a-02b424572f06 53208-524 HUMAN OTC DRUG OHUI Sun Science Sun Block EX plus Beige TALC, OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE, ARBUTIN, ATRACTYLODES JAPONICA ROOT OIL POWDER TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ARBUTIN; ATRACTYLODES JAPONICA ROOT OIL; OCTINOXATE; TALC; TITANIUM DIOXIDE; ZINC OXIDE 2; .1; 7.2; 55.493; 2.59956; 5.76 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 53208-525_aae58d31-6547-4887-a0b9-7e6b3597aaba 53208-525 HUMAN OTC DRUG THE HISTORY OF WHOO GONGJINHYANG SEOL WHITENING SUN ZINC OXIDE, ENSULIZOLE, POLYSILICONE-15, TITANIUM DIOXIDE, ATRACTYLODES JAPONICA ROOT OIL CREAM TOPICAL 20110524 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ATRACTYLODES JAPONICA ROOT OIL; ENSULIZOLE; POLYSILICONE-15; TITANIUM DIOXIDE; ZINC OXIDE .05; 3.9; 3; 2.48; 6.117 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 53208-528_1978fc3b-df4e-4287-8e6b-70a7438a43d4 53208-528 HUMAN OTC DRUG CATHYCAT ESSENCE SUN BB Titanium Dioxide, OCTINOXATE, Zinc Oxide, AMILOXATE LIQUID TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. AMILOXATE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1; 7; 13.76176; 3.92 mL/100mL; mL/100mL; mL/100mL; mL/100mL 53208-530_ce1366cf-01c4-4e87-87b4-b2767a6a0c0a 53208-530 HUMAN OTC DRUG ISAKNOX TERVINA LUMIERE WHITE METHYL UNDECENOYL LEUCINATE CREAM TOPICAL 20110525 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. METHYL UNDECENOYL LEUCINATE .1 mL/100mL 53208-531_53f6cd07-a734-4ea2-a512-fcbc28746796 53208-531 HUMAN OTC DRUG ISAKNOX X202 WHITENING SECRET ESSENCE DIOSMETIN CREAM TOPICAL 20110601 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. DIOSMETIN .055 mL/100mL 53208-533_68a74fbc-b6d6-40b7-9f53-095fed7e1fe4 53208-533 HUMAN OTC DRUG OHUI White Extreme Illuminating Pact No.10 TITANIUM DIOXIDE, OCTINOXATE, ARBUTIN, ATRACTYLODES JAPONICA ROOT OIL POWDER TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ARBUTIN; ATRACTYLODES JAPONICA ROOT OIL; OCTINOXATE; TITANIUM DIOXIDE 2; .1; 4.5; 9.84 g/100g; g/100g; g/100g; g/100g 53208-534_6c06b338-5bcc-4743-a8a2-646827541f11 53208-534 HUMAN OTC DRUG OHUI White Extreme Illuminating Pact No.10 TITANIUM DIOXIDE, OCTINOXATE, ARBUTIN, ATRACTYLODES JAPONICA ROOT OIL POWDER TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ARBUTIN; ATRACTYLODES JAPONICA ROOT OIL; OCTINOXATE; TITANIUM DIOXIDE 2; .1; 4.5; 9.84 g/100g; g/100g; g/100g; g/100g 53208-538_493b4e2c-9c76-4ee0-a7c6-83406607b171 53208-538 HUMAN OTC DRUG OHUI SUN SCIENCE Perfect Sunblock black EX plus ZINC OXIDE, TITANIUM DIOXIDE, ENSULIZOLE CREAM TOPICAL 20110803 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ENSULIZOLE; TITANIUM DIOXIDE; ZINC OXIDE 3.9; 10; 22.7 mL/100mL; mL/100mL; mL/100mL 53208-539_5563affb-146e-4f66-b499-596dcf74e74f 53208-539 HUMAN OTC DRUG OHUI SUN SCIENCE Perfect Sunblock Blue EX plus TITANIUM DIOXIDE, OCTOCRYLENE, POLYSILICONE-15, OCTISALATE, ENSULIZOLE, BEMOTRIZINOL CREAM TOPICAL 20110803 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. BEMOTRIZINOL; ENSULIZOLE; OCTISALATE; POLYSILICONE-15; TITANIUM DIOXIDE 2; 3.9; 4.8; 5; 9 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 53208-541_adeb0651-a126-4e8e-bda2-54927459d41c 53208-541 HUMAN OTC DRUG SOORYEHAN ONBIT ESSENCE FOUNDATION 21 OCTINOXATE, TITANIUM DIOXIDE, ALUMINUM HYDROXIDE, STEARIC ACID, HYDROXYPROLINE CREAM TOPICAL 20110825 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ALUMINUM HYDROXIDE; HYDROXYPROLINE; OCTINOXATE; STEARIC ACID; TITANIUM DIOXIDE .1; .5; 3; .1; .8 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 53208-545_a597aa2e-ca1f-4784-ab6d-e264410ed91c 53208-545 HUMAN OTC DRUG Soorhyehan Onbit Two Way Cake 23 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20110825 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; TITANIUM DIOXIDE 4; 5.88 g/100g; g/100g 53208-549_b6962d6b-f69c-4375-8bdc-4c1a1853552b 53208-549 HUMAN OTC DRUG SOORYEHAN HYO FERMENTED SUN BLOCK ZINC OXIDE, TITANIUM DIOXIDE, ENSULIZOLE CREAM TOPICAL 20110927 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. AMILOXATE; BEMOTRIZINOL; DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE; ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE; TROMETHAMINE 1.6; 1; 1; 3.9; 7; 2.52; 2.63 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 53208-550_66bd13bf-1cc9-4be3-9293-20e72e3c6595 53208-550 HUMAN OTC DRUG OHUI AGE RECOVERY TRI SHIELD PACT 10 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20111011 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; TITANIUM DIOXIDE 2; 4.9 g/100g; g/100g 53208-551_bffe4087-0880-49cd-959a-203af5015cc1 53208-551 HUMAN OTC DRUG OH Age recovery Tri Shield pact 10 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20110927 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; TITANIUM DIOXIDE 2; 4.9 g/100g; g/100g 53210-1001_8bc77776-7313-4c74-88b0-8122b1d7df33 53210-1001 HUMAN OTC DRUG Tolnaftate TOLNAFTATE CREAM TOPICAL 20120925 OTC MONOGRAPH FINAL part333C Morales Distributors, Inc. TOLNAFTATE 1 g/100g 53210-1002_71b8d41c-4468-448a-8cb6-5f03b0852596 53210-1002 HUMAN OTC DRUG Hydrocortisone HYDROCORTISONE CREAM TOPICAL 20120925 OTC MONOGRAPH NOT FINAL part348 Morales Distributors Inc HYDROCORTISONE 1 g/100g 53210-1003_e90595b3-d065-4c09-afbd-7c3ae3e95bd4 53210-1003 HUMAN OTC DRUG Antibiotic NEOMYCIN SULFATE OINTMENT TOPICAL 20120925 OTC MONOGRAPH FINAL part333B Morales Distributors Inc NEOMYCIN SULFATE 3.5 mg/g 53210-1004_3173a08b-5f96-4c1e-8668-9c34360fb55f 53210-1004 HUMAN OTC DRUG Triple Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE OINTMENT TOPICAL 20120926 OTC MONOGRAPH FINAL part333B Morales Distributors Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 U/g; mg/g; U/g 53217-001_69b4a3d6-0e03-4e4b-9377-0926bae0faef 53217-001 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Aidarex Pharmaceuticals LLC WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 53217-003_d8132b9b-3eb6-4b19-a8cc-4a67712e19d0 53217-003 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 19970328 ANDA ANDA074532 Aidarex Pharmaceuticals LLC CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 53217-004_2d60485d-d6e7-47d7-813d-0db3a3214e20 53217-004 HUMAN OTC DRUG New Terocin Methyl Salicylate, Capsaicin, and Menthol LOTION TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part348 Aidarex Pharmaceuticals LLC CAPSAICIN; MENTHOL; METHYL SALICYLATE .025; 10; 25 g/100mL; g/100mL; g/100mL 53217-005_8da49cda-f1fa-4227-9892-57f67235f68b 53217-005 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Aidarex Pharmaceuticals LLC DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 53217-006_6947b532-323d-413d-b76d-7ea159b285b7 53217-006 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 Aidarex Pharmaceuticals LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 53217-007_de01a1bf-91d5-43b3-b516-dfa6fb5d4316 53217-007 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040788 Aidarex Pharmaceuticals LLC HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 53217-008_3a79526b-bcfe-4635-82a6-73cafe9b13eb 53217-008 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20110201 ANDA ANDA075693 Aidarex Pharmaceuticals LLC IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 53217-009_9be2d0a1-1415-47de-87f0-03a66680c62f 53217-009 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL 19950703 ANDA ANDA074076 Aidarex Pharmaceuticals LLC LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 53217-010_c8bbdb77-8cb5-437b-96b7-a064ba98c84d 53217-010 HUMAN PRESCRIPTION DRUG NifedicalXL XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20001211 ANDA ANDA075289 Aidarex Pharmaceuticals LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53217-011_909139f0-c2f9-4004-a245-b38cf54c4869 53217-011 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Aidarex Pharmaceuticals LLC SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 53217-012_8d6a065d-30d4-4b0d-a51e-cc101b8271a8 53217-012 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Aidarex Pharmaceuticals LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 53217-014_278d33d3-ae7b-40ec-9ff4-8f6d667e3f50 53217-014 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide CREAM TOPICAL 20060609 ANDA ANDA040671 Aidarex Pharmaceuticals LLC TRIAMCINOLONE ACETONIDE .25 mg/g 53217-015_60077487-aec7-4042-99ec-6f531bb31fdf 53217-015 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole SHAMPOO, SUSPENSION TOPICAL 20100119 ANDA ANDA076419 Aidarex Pharmaceuticals LLC KETOCONAZOLE 20 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 53217-018_569f166d-b427-4409-9418-8432052de580 53217-018 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Aidarex Pharmaceuticals LLC WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 53217-019_3a77ea51-3169-45d6-ae45-7e2bdaea2347 53217-019 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Aidarex Pharmaceuticals LLC HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 53217-020_3322107f-096e-40f9-96be-bcd71578c47f 53217-020 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20110101 ANDA ANDA040182 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 167; 2.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 53217-021_c7176ee9-dfa5-47e9-b972-17c2273a81ea 53217-021 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin GEL TOPICAL 20080612 ANDA ANDA063211 Aidarex Pharmaceuticals LLC ERYTHROMYCIN 20 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 53217-022_342bbf92-0160-4f92-b1ce-98cedd5fd6d5 53217-022 HUMAN PRESCRIPTION DRUG Nystatin Nystatin OINTMENT TOPICAL 20020903 ANDA ANDA062840 Aidarex Pharmaceuticals LLC NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 53217-024_0b3cb041-1d4b-486d-937b-95e06b0b9882 53217-024 HUMAN OTC DRUG ROBAFEN COUGH FORMULA Guaifenesin SYRUP ORAL 20120815 OTC MONOGRAPH FINAL part341 Aidarex Pharmaceuticals LLC GUAIFENESIN 100 mg/5mL 53217-026_bcc54b4f-bf01-40dc-82e3-633f8bb1054a 53217-026 HUMAN OTC DRUG LenzaGel LIDOCAINE HYDROCHLORIDE, MENTHOL GEL TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 Aidarex Pharmaceuticals LLC LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g 53217-040_89d35016-9fee-46c7-8f7d-9168a2ad383a 53217-040 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 53217-054_7e0d9034-c76b-4349-8443-ababb9db92a3 53217-054 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED ORAL 20100524 ANDA ANDA090216 Aidarex Pharmaceuticals LLC VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 53217-058_c5eb25f0-c650-4cc7-8f2c-60574e93c8fc 53217-058 HUMAN OTC DRUG Bismatrol Bismuth subsalicylate TABLET, CHEWABLE ORAL 20030103 OTC MONOGRAPH FINAL part335 Aidarex Pharmaceuticals LLC BISMUTH SUBSALICYLATE 262 mg/1 53217-060_55591708-1dc9-45bb-8870-12609d4b51c7 53217-060 HUMAN OTC DRUG Bismatrol Bismuth Subsalicylate LIQUID ORAL 20080530 OTC MONOGRAPH FINAL part335 Aidarex Pharmaceuticals LLC BISMUTH SUBSALICYLATE 262 mg/15mL 53217-063_b50ba291-8672-4722-99a8-73aa624ad39b 53217-063 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL 20091105 UNAPPROVED DRUG OTHER Aidarex Pharmaceuticals LLC HYOSCYAMINE SULFATE .125 mg/1 53217-064_66c9882a-58ad-4edd-8183-db4352828a50 53217-064 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine GEL TOPICAL 20130301 UNAPPROVED DRUG OTHER Aidarex Pharmaceuticals LLC LIDOCAINE 30 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 53217-066_1ffe0c86-333f-4852-9051-3c98411e494d 53217-066 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 Aidarex Pharmaceuticals LLC NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 53217-070_9e51fa64-b081-4deb-8f8c-a21836a381d4 53217-070 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20121018 ANDA ANDA070791 Aidarex Pharmaceuticals LLC DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 53218-001_f7d78925-b307-fd57-1b8c-128808d408c6 53218-001 HUMAN OTC DRUG Total White Brightening Hydroquinone, Ethylhexyl Methoxycinnamate LOTION TOPICAL 20121010 OTC MONOGRAPH NOT FINAL part352 YZY Inc HYDROQUINONE; OCTINOXATE 9.46; 14.19 mg/473mL; mg/473mL 53218-002_a1adbdb7-d742-222d-dd33-1d274a198ec1 53218-002 HUMAN OTC DRUG Total White Brightening Hydroquinone, Ethylhexyl Methoxycinnamate CREAM TOPICAL 20121010 OTC MONOGRAPH NOT FINAL part352 YZY Inc HYDROQUINONE; OCTINOXATE 2; 3 g/100g; g/100g 53225-1021_079c4f1c-8356-1113-e054-00144ff8d46c 53225-1021 HUMAN OTC DRUG LidoPro Capsaicin, Lidocaine, Menthol, and Methyl Salicylate OINTMENT TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part348 Terrain Pharmaceuticals CAPSAICIN; LIDOCAINE; MENTHOL; METHYL SALICYLATE .000325; .045; .1; .275 g/g; g/g; g/g; g/g 53225-1022_079bede5-f600-03ed-e054-00144ff8d46c 53225-1022 HUMAN OTC DRUG LidoPro Capsaicin, Lidocaine, Menthol, and Methyl Salicylate OINTMENT TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part348 Terrain Pharmaceuticals CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE .000325; .04; .1; .275 g/g; g/g; g/g; g/g 53225-1023_0943ccb6-c1ef-3a6f-e054-00144ff88e88 53225-1023 HUMAN OTC DRUG LidoPro Patch Lidocaine, Menthol, and Methyl Salicylate PATCH TOPICAL 20141202 OTC MONOGRAPH NOT FINAL part348 Terrain Pharmaceuticals LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE .04; .05; .04 1/1; 1/1; 1/1 53228-001_50180d0c-f93c-4653-86a5-3e3704b27e7d 53228-001 HUMAN OTC DRUG finipil pro/elec BENZETHONIUM CHLORIDE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part333A Equibal, Inc. BENZETHONIUM CHLORIDE 195 mg/100mL 53228-002_26506404-1de4-4d12-b4bf-e6302d0153d9 53228-002 HUMAN OTC DRUG BlemFree SALICYLIC ACID LOTION TOPICAL 20140801 OTC MONOGRAPH FINAL part333D Equibal, Inc. SALICYLIC ACID .587 g/118mL 53228-050_4b6a688b-ac85-4fc9-967d-84c14f4a9229 53228-050 HUMAN OTC DRUG finipil Lait 50 BENZETHONIUM CHLORIDE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part333A Equibal, Inc. BENZETHONIUM CHLORIDE 195 mg/100mL 53238-001_704df6e8-8203-4b26-8d7e-45ea367dba33 53238-001 HUMAN OTC DRUG PERIOSCIENCES White Care AO Pro SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20120913 OTC MONOGRAPH FINAL part355 PERIOSCIENCES LLC SODIUM FLUORIDE .24 mg/100mL 53238-002_7b95d761-0132-4ea7-87b9-65a76e23b59a 53238-002 HUMAN OTC DRUG PERIOSCIENCES SENSITIVE AO Pro POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20130527 OTC MONOGRAPH NOT FINAL part356 PERIOSCIENCES LLC POTASSIUM NITRATE; SODIUM MONOFLUOROPHOSPHATE 50; 1.3 mg/mL; mg/mL 53238-003_624a13f4-3d95-4834-abb6-7545bc813992 53238-003 HUMAN OTC DRUG PERIOSCIENCES HYDRATING AO Pro SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20130527 OTC MONOGRAPH FINAL part355 PERIOSCIENCES LLC SODIUM MONOFLUOROPHOSPHATE 1.3 mg/mL 53240-151_af2ec66e-18ce-47da-a66f-887ceff6356e 53240-151 HUMAN OTC DRUG Zephrex-D Pseudoephedrine Hydrochloride TABLET ORAL 20121115 OTC MONOGRAPH FINAL part341 Westport Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 53241-010_0627afa2-1500-4316-b7bf-ecb3259c74e7 53241-010 HUMAN OTC DRUG RACHEL K MINERAL CC BLEMISH BALM TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20120115 OTC MONOGRAPH FINAL part352 RACHEL K COSMETICS PTE. LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 2; .8; 2.4 g/40g; g/40g; g/40g 53241-020_854a0f8d-21b6-48de-b07b-7a287424df57 53241-020 HUMAN OTC DRUG RACHEL K MINERAL CC PRESSED TITANIUM DIOXIDE POWDER TOPICAL 20120115 OTC MONOGRAPH FINAL part352 RACHEL K COSMETICS PTE. LTD. TITANIUM DIOXIDE .84 g/12g 53247-330_0e0dd599-5716-49bf-8a60-efb6078543f3 53247-330 HUMAN OTC DRUG Liceall piperonyl butoxide, pyrethrum extract SHAMPOO TOPICAL 20100420 OTC MONOGRAPH FINAL part358G Bob Barker Company, Inc. PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 3; .3 g/100mL; g/100mL 53247-467_62114cb2-28c0-4665-9e11-77a3366d8821 53247-467 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol GEL TOPICAL 20121008 OTC MONOGRAPH NOT FINAL part333A Bob Barker ALCOHOL 62 mL/100mL 53262-001_b5eae714-d753-42ea-a3a1-c3a8ed6e6db2 53262-001 HUMAN OTC DRUG In-7-One SODIUM MONOFLUOROPHOSPHATE GEL, DENTIFRICE DENTAL 20130606 OTC MONOGRAPH FINAL part355 Power Unit Toothbrush Inc SODIUM MONOFLUOROPHOSPHATE .14 g/100g 53270-0051_148e1fa7-efc7-47be-a20a-1e9a623852e2 53270-0051 PLASMA DERIVATIVE HepaGam B Hepatitis B Immune Globulin (Human) INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 BLA BLA125035 Cangene bioPharma Inc. HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 312 [iU]/mL Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] 53270-0052_148e1fa7-efc7-47be-a20a-1e9a623852e2 53270-0052 PLASMA DERIVATIVE HepaGam B Hepatitis B Immune Globulin (Human) INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 BLA BLA125035 Cangene bioPharma Inc. HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 312 [iU]/mL Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] 53270-0053_80484545-800b-47ad-a45a-4acc91e5bfb5 53270-0053 HUMAN PRESCRIPTION DRUG HepaGam B Hepatitis B Immune Globulin (Human) INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 BLA BLA125035 Cangene bioPharma Inc. HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 50 mg/mL Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] 53270-0054_80484545-800b-47ad-a45a-4acc91e5bfb5 53270-0054 HUMAN PRESCRIPTION DRUG HepaGam B Hepatitis B Immune Globulin (Human) INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 BLA BLA125035 Cangene bioPharma Inc. HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 50 mg/mL Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] 53270-0125_16611713-5942-46f5-9be6-a092dde4a1a5 53270-0125 PLASMA DERIVATIVE VARIZIG Varicella Zoster Immune Globulin (Human) KIT 20130226 BLA BLA125430 Cangene BioPharma 53270-3000_1369e7d0-4d2b-4bee-92bd-3878be1261b2 53270-3000 HUMAN PRESCRIPTION DRUG WINRHO rho (d) immune globulin LIQUID INTRAMUSCULAR; INTRAVENOUS 20050331 BLA BLA103649 Cangene bioPharma Inc. HUMAN IMMUNOGLOBULIN G 15000 [iU]/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 53270-3100_1369e7d0-4d2b-4bee-92bd-3878be1261b2 53270-3100 HUMAN PRESCRIPTION DRUG WINRHO rho (d) immune globulin LIQUID INTRAMUSCULAR; INTRAVENOUS 20040331 BLA BLA103649 Cangene bioPharma Inc. HUMAN IMMUNOGLOBULIN G 5000 [iU]/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 53270-3120_1369e7d0-4d2b-4bee-92bd-3878be1261b2 53270-3120 HUMAN PRESCRIPTION DRUG WINRHO rho (d) immune globulin LIQUID INTRAMUSCULAR; INTRAVENOUS 20050331 BLA BLA103649 Cangene bioPharma Inc. HUMAN IMMUNOGLOBULIN G 600 [iU]/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 53270-3300_1369e7d0-4d2b-4bee-92bd-3878be1261b2 53270-3300 HUMAN PRESCRIPTION DRUG WINRHO rho (d) immune globulin LIQUID INTRAMUSCULAR; INTRAVENOUS 20050331 BLA BLA103649 Cangene bioPharma Inc. HUMAN IMMUNOGLOBULIN G 1500 [iU]/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 53270-3500_1369e7d0-4d2b-4bee-92bd-3878be1261b2 53270-3500 HUMAN PRESCRIPTION DRUG WINRHO rho (d) immune globulin LIQUID INTRAMUSCULAR; INTRAVENOUS 20050331 BLA BLA103649 Cangene bioPharma Inc. HUMAN IMMUNOGLOBULIN G 2500 [iU]/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 53304-0301_46b38a46-4d28-4a88-aaec-ed23e9ff3f70 53304-0301 HUMAN OTC DRUG EB301AP PAIN RELIEF MENTHOL SPRAY TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 EMINENCE BIOTECH CORPORATION LIMITED MENTHOL 1000 mg/100mL 53304-0302_b3f3d999-4018-49cc-a71f-5535af660860 53304-0302 HUMAN OTC DRUG EB302 ARTHRITIS RELIEF MENTHOL SPRAY TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part348 EMINENCE BIOTECH CORPORATION LIMITED MENTHOL 865.4 mg/50mL 53304-0306_3b11ba92-3a4b-49cf-9aea-88fd0fc04ed4 53304-0306 HUMAN OTC DRUG EB306 NASAL DECONGESTANT PHENYLEPHRINE HYDROCHLORIDE SPRAY NASAL 20121101 OTC MONOGRAPH FINAL part341 EMINENCE BIOTECH CORPORATION LIMITED PHENYLEPHRINE HYDROCHLORIDE 21.73 mg/15mL 53304-1301_a1a9bac8-a4cc-4d5a-b042-c85bf1a41e2e 53304-1301 HUMAN OTC DRUG EB301CT BRUISE PAIN RELIEF MENTHOL SPRAY TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 EMINENCE BIOTECH CORPORATION LIMITED MENTHOL 1700 mg/100mL 53305-065_645942a5-a817-4358-8ab4-ae61092d63cf 53305-065 HUMAN OTC DRUG Dreumex Omnicare Hand Sanitizer Alcohol SPRAY TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part333E Gent-l-kleen Products, Inc. ALCOHOL 800 mg/1.2mL 53305-074_a0f7e2af-0fa6-4293-9181-d6bcad8c284d 53305-074 HUMAN OTC DRUG Dreumex Omnicare Triclosan AEROSOL, FOAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333A Gent-l-kleen Products, Inc. TRICLOSAN 2.94 ug/mL 53305-075_488fda08-083f-46b3-99c7-791008de5215 53305-075 HUMAN OTC DRUG Dreumex Omnicare Hand Sanitizer Alcohol GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Gent-l-kleen Products, Inc. ALCOHOL 800 mg/1.2mL 53314-1066_5df04858-57ee-41aa-90a7-ae1b1f36a876 53314-1066 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19740101 UNAPPROVED MEDICAL GAS Welder Services of Fort Wayne, Inc. NITROGEN 99 L/100L 53314-1072_0b54b51c-9a95-4c27-b4f0-a396917bc44d 53314-1072 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19740101 UNAPPROVED MEDICAL GAS Welder Services Of Fort Wayne, Inc. OXYGEN 99 L/100L 53329-004_4d2a472b-1fa6-48ac-8721-dcfe74e1c462 53329-004 HUMAN OTC DRUG Soothe and Cool Free Skin Paste Zinc Oxide and White Petrolatum PASTE TOPICAL 20070101 OTC MONOGRAPH FINAL part346 Medline Industries, Inc. PETROLATUM; ZINC OXIDE 500; 100 mg/g; mg/g 53329-005_b98e3401-d929-493a-85a9-c541ce406849 53329-005 HUMAN OTC DRUG Curad Saline Laxative sodium phosphate ENEMA RECTAL 20120716 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 53329-006_11b627f0-8668-405a-a0b2-f6cbb2958d55 53329-006 HUMAN OTC DRUG CURAD Lubricant Laxative mineral oil ENEMA RECTAL 20120716 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. MINERAL OIL 118 mL/118mL 53329-007_d26aa127-0aff-43b2-b5f3-fca9bd58cc7f 53329-007 HUMAN OTC DRUG Medline Enema Sodium Phosphate ENEMA RECTAL 20100106 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 53329-008_d86eb752-13a9-42df-9f36-d236f60142d1 53329-008 HUMAN OTC DRUG Medline Enema Mineral Oil ENEMA RECTAL 20100106 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. MINERAL OIL 118 mL/118mL 53329-010_4aad51ee-d778-4547-b123-e19ac60171ca 53329-010 HUMAN OTC DRUG Antiperspirant aluminum chlorohydrate SPRAY TOPICAL 20100601 OTC MONOGRAPH FINAL part350 Medline Industries, Inc. ALUMINUM CHLOROHYDRATE 13 mL/100mL 53329-012_e3df3ce5-71a5-470c-8c56-5cba60d24189 53329-012 HUMAN OTC DRUG Fresh Prep Laxative sodium phosphate ENEMA RECTAL 20120716 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 53329-013_96d4cad5-0602-4c31-94ed-3117b4fd4a94 53329-013 HUMAN OTC DRUG Pure and Gentle Mineral Oil Enema mineral oil ENEMA RECTAL 20140409 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. MINERAL OIL 118 mL/118mL 53329-014_e3165538-75dd-4f0f-adc8-d4075de10f1e 53329-014 HUMAN OTC DRUG Pure and Gentle Laxative sodium phosphate ENEMA RECTAL 20140409 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 53329-015_8b08e241-00b3-4110-b984-5af6f0c111cf 53329-015 HUMAN OTC DRUG Medline Saline Laxative For Children sodium phosphate ENEMA RECTAL 20140327 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 3.5; 9.5 g/59mL; g/59mL 53329-018_1ccf5a0a-1539-4c12-bf87-763814a313c8 53329-018 HUMAN OTC DRUG Skintegrity Antibacterial Hand Amber Triclosan SOAP TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. TRICLOSAN .5 mL/100mL 53329-019_85c8bff9-8286-4c6f-9eb7-547b16c59f30 53329-019 HUMAN OTC DRUG Skintegrity Antibacterial Hand Clear Triclosan SOAP TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. TRICLOSAN .5 mg/100mL 53329-040_ddaf6fd2-f05e-4b02-873a-6d6712ac1153 53329-040 HUMAN OTC DRUG Soothe and Cool Fresh Dandruff Control Shampoo Pyrithione Zinc SHAMPOO TOPICAL 20070101 OTC MONOGRAPH FINAL part358H Medline Industries, Inc. PYRITHIONE ZINC 10 mg/mL 53329-042_6ecb3fe9-6eb6-45cf-b721-a4603597191c 53329-042 HUMAN OTC DRUG Soothe and Cool Free Medseptic Skin Protectant Lanolin OINTMENT TOPICAL 20070101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. LANOLIN 500 mg/g 53329-043_f8366a24-06ac-4417-a1fc-ea7338a0781d 53329-043 HUMAN OTC DRUG Skintegrity Antibacterial Hand Blue Triclosan SOAP TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. TRICLOSAN .5 mL/100mL 53329-048_dbcd6aa0-1107-4c74-8f8b-35e412f9ce4d 53329-048 HUMAN OTC DRUG Antibacterial Bar Triclosan SOAP TOPICAL 20100802 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. TRICLOSAN .3 g/100g 53329-050_77c48a65-060a-4d86-9a90-c308fd3c8bb8 53329-050 HUMAN OTC DRUG Skintegrity Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20080701 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 62 mL/100mL 53329-051_84db6f25-9b77-4064-98d9-b327d39c1c95 53329-051 HUMAN OTC DRUG Soothe and Cool Non-Caking Body Starch, Corn POWDER TOPICAL 20050101 20161130 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. STARCH, CORN 800 mg/g 53329-053_84db6f25-9b77-4064-98d9-b327d39c1c95 53329-053 HUMAN OTC DRUG Soothe and Cool Non-Caking Body Starch, Corn POWDER TOPICAL 20050101 20161130 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. STARCH, CORN 800 mg/g 53329-055_defd825a-e740-448e-b6bc-0622e86abacb 53329-055 HUMAN OTC DRUG Medline ReadyBath Luxe Antibacterial Formula Benzalkonium Chloride CLOTH TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .12 mg/100mL 53329-056_defd825a-e740-448e-b6bc-0622e86abacb 53329-056 HUMAN OTC DRUG Medline ReadyBath Luxe Antibacterial Formula Fragrance Free Benzalkonium Chloride CLOTH TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .12 mg/100mL 53329-057_defd825a-e740-448e-b6bc-0622e86abacb 53329-057 HUMAN OTC DRUG Medline ReadyBath Select Antibacterial Formula Benzalkonium Chloride CLOTH TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .12 mg/100mL 53329-058_defd825a-e740-448e-b6bc-0622e86abacb 53329-058 HUMAN OTC DRUG Medline ReadyBath Select Antibacterial Formula Fragrance Free Benzalkonium Chloride CLOTH TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .12 mg/100mL 53329-059_d5d578ed-9e0f-4de8-8d1a-7290e0659076 53329-059 HUMAN OTC DRUG Aloetouch Protect Skin Protectant Wipes Fragrance Free Dimethicone CLOTH TOPICAL 20120801 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 3.2 g/100mL 53329-060_22b7310d-b89a-4f4c-8650-2ba8971cbd91 53329-060 HUMAN OTC DRUG Readybath TPC Total Perineal Care Dimethicone CLOTH TOPICAL 20070101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE .032 mL/1 53329-061_22b7310d-b89a-4f4c-8650-2ba8971cbd91 53329-061 HUMAN OTC DRUG Readybath TPC Dimethicone CLOTH TOPICAL 20070101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE .032 mL/1 53329-062_22b7310d-b89a-4f4c-8650-2ba8971cbd91 53329-062 HUMAN OTC DRUG Readycleanse Cleansing Wipes Dimethicone CLOTH TOPICAL 20070101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE .032 1/1 53329-063_22b7310d-b89a-4f4c-8650-2ba8971cbd91 53329-063 HUMAN OTC DRUG Aloetouch Premium Spunlace Cleansing Cloths Dimethicone CLOTH TOPICAL 20070101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE .032 mL/1 53329-065_22b7310d-b89a-4f4c-8650-2ba8971cbd91 53329-065 HUMAN OTC DRUG Aloetouch Premium Spunlace Dimethicone CLOTH TOPICAL 20070101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE .032 mL/1 53329-066_22b7310d-b89a-4f4c-8650-2ba8971cbd91 53329-066 HUMAN OTC DRUG Readyflush XLarge Personal Cleansing Cloths Dimethicone CLOTH TOPICAL 20070101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE .032 mL/1 53329-067_d19a13dd-d5cf-45b4-9f66-0ad243d741db 53329-067 HUMAN OTC DRUG Vitamins A and D Ointment White Petrolatum OINTMENT TOPICAL 20070101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. PETROLATUM 935 mg/g 53329-068_8a8ea969-241e-4e68-bff3-ab25b0440a53 53329-068 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20100101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. PETROLATUM 1 g/g 53329-069_5ce9b39e-c190-4c0e-b900-418f681a8bd1 53329-069 HUMAN OTC DRUG Roll On Anti Perspirant Alcohol Free Aluminum Chlorohydrate SOLUTION TOPICAL 20070101 OTC MONOGRAPH FINAL part350 Medline Industries, Inc. ALUMINUM CHLOROHYDRATE 10 mg/100mL 53329-071_59625382-2769-4c91-9c53-e19dfd6ca115 53329-071 HUMAN OTC DRUG Soothe and Cool Moisture Barrier Petrolatum OINTMENT TOPICAL 20060301 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. PETROLATUM 98.3 g/100g 53329-072_a143042d-5de5-4440-8750-2b56f3b817c6 53329-072 HUMAN OTC DRUG Soothe and Cool Free Moisture Barrier Petrolatum OINTMENT TOPICAL 20070101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. PETROLATUM 92.8 g/100g 53329-073_15c3564c-7a60-4d47-bd78-ed466e874e8c 53329-073 HUMAN OTC DRUG MicroKlenz Antimicrobial Benzethonium Chloride LIQUID TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZETHONIUM CHLORIDE .1 mg/100mL 53329-075_743d21bd-c40a-4415-ad97-0d8aa99a8af7 53329-075 HUMAN OTC DRUG Readyflush Protect Wipes Fragrance Free Dimethicone CLOTH TOPICAL 20120801 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 3.2 g/100mL 53329-076_59929aa1-aeee-4ac4-9174-f27ee631d870 53329-076 HUMAN OTC DRUG Carrington Moisture Barrier Petrolatum CREAM TOPICAL 20070101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. PETROLATUM .61 g/g 53329-077_c726eb2d-4a2a-4bc6-b939-2d2f7d5e4965 53329-077 HUMAN OTC DRUG Carrington Moisture Barrier Zinc Oxide and Petrolatum CREAM TOPICAL 20070101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. PETROLATUM; ZINC OXIDE .78; .1 g/g; g/g 53329-078_00e0cd4a-6049-408a-ab3f-9edf97e6438a 53329-078 HUMAN OTC DRUG Remedy Barrier Cream Cloths Dimethicone CLOTH TOPICAL 20131219 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 3.6 g/100mL 53329-079_e8175c98-6a4e-4a79-b27d-6eb7aa91d9e7 53329-079 HUMAN OTC DRUG Carrington Antifungal Miconazole Nitrate CREAM TOPICAL 20070101 OTC MONOGRAPH FINAL part333C Medline Industries, Inc. MICONAZOLE NITRATE 20 mg/g 53329-080_e8175c98-6a4e-4a79-b27d-6eb7aa91d9e7 53329-080 HUMAN OTC DRUG Soothe And Cool Free INZO Antifungal Miconazole Nitrate CREAM TOPICAL 20070101 OTC MONOGRAPH FINAL part333C Medline Industries, Inc. MICONAZOLE NITRATE 20 mg/g 53329-082_aa00b153-5524-4400-b24f-20dfdd74b272 53329-082 HUMAN OTC DRUG Sparkle Fresh Anticavity Sodium Fluoride PASTE, DENTIFRICE DENTAL 20080401 OTC MONOGRAPH FINAL part355 Medline Industries, Inc. SODIUM FLUORIDE 2.4 mg/g 53329-083_0ff7b830-80c1-4824-812c-4a980a4e445c 53329-083 HUMAN OTC DRUG SparkleFresh Fluoride Toothpaste Sodium Monofluorophosphate PASTE, DENTIFRICE TOPICAL 20070101 OTC MONOGRAPH FINAL part355 Medline Industries, Inc. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 53329-084_0e9d0ccd-d67c-4699-9280-26514e39cfba 53329-084 HUMAN OTC DRUG RadiaBlock Oxybenzone, Padimate O LIPSTICK TOPICAL 20010901 OTC MONOGRAPH NOT FINAL part352 Medline Industries, Inc. OXYBENZONE; PADIMATE O 30; 70 mg/g; mg/g 53329-086_1d02ebb9-7834-4d94-9e07-2bc6c27eb50d 53329-086 HUMAN OTC DRUG Medline Peroxi Fresh Mouthwash Hydrogen Peroxide MOUTHWASH DENTAL 20070101 OTC MONOGRAPH FINAL part355 Medline Industries, Inc. HYDROGEN PEROXIDE 15 mg/mL 53329-087_fd8a13d7-4054-487f-a9c9-9ef144b397fd 53329-087 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin B sulfate OINTMENT TOPICAL 20100401 OTC MONOGRAPH FINAL part333B Medline Industries, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 53329-088_f78d38ca-df96-4f36-8351-e6cbe320f7e9 53329-088 HUMAN OTC DRUG Anorectal zinc oxide, petrolatum CREAM TOPICAL 20100301 OTC MONOGRAPH FINAL part346 Medline Industries, Inc. PETROLATUM; ZINC OXIDE 800; 200 mg/g; mg/g 53329-089_c3003311-8dde-47bd-8730-05c66e842a6e 53329-089 HUMAN OTC DRUG First Aid Antibiotic bacitracin zinc OINTMENT TOPICAL 20100301 OTC MONOGRAPH FINAL part333B Medline Industries, Inc. BACITRACIN ZINC 500 [USP'U]/g 53329-090_f1dafec5-bd55-43f5-a1e8-9d31e5add075 53329-090 HUMAN OTC DRUG Vitamin A and D Skin Protectant OINTMENT TOPICAL 20100301 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. PETROLATUM 935 mg/g 53329-091_c3ed3405-3a6b-4df3-95d9-0766cac41655 53329-091 HUMAN OTC DRUG Anti-itch hydrocortisone CREAM TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part348 Medline Industries, Inc. HYDROCORTISONE 10 mg/g 53329-092_6125d98a-6fc7-4f50-924e-3b1f7ee951f4 53329-092 HUMAN OTC DRUG Petroleum-Free Lip Balm Octinoxate and Oxybenzone LIPSTICK TOPICAL 20100401 OTC MONOGRAPH FINAL part352 Medline Industries, Inc. OCTINOXATE; OXYBENZONE 2; 4.5 g/100g; g/100g 53329-094_a82dbb9c-a101-4045-89f6-5def8096546e 53329-094 HUMAN OTC DRUG RadiaBlock Oxybenzone, Octinoxate LIPSTICK TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Medline Industries, Inc. OCTINOXATE; OXYBENZONE 75; 30 mg/g; mg/g 53329-096_06d78433-0e6e-4945-8e7a-e609de0186e0 53329-096 HUMAN OTC DRUG Remedy Zinc Skin Protectant White Petrolatum PASTE TOPICAL 20140403 OTC MONOGRAPH FINAL part347 Medline Industries Inc. PETROLATUM; ZINC OXIDE 80; 20 g/100g; g/100g 53329-101_b8ce719c-2014-4fff-85e2-7c712c1b0d50 53329-101 HUMAN OTC DRUG Natural Fiber Powder Sugar Free Orange Flavor Psyllium husk POWDER ORAL 20090101 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. PLANTAGO SEED 3400 mg/g 53329-102_d8ced315-6830-4587-b8f3-3cc280b31d0c 53329-102 HUMAN OTC DRUG Natural Fiber Powder Orange Flavor Psyllium husk POWDER ORAL 20090101 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. PLANTAGO SEED 3400 mg/g 53329-110_915cee8e-0b3e-4c19-b1ce-114918189567 53329-110 HUMAN OTC DRUG Curad Oral Saline Laxative dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20120716 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 2.9; 7.2 g/15mL; g/15mL 53329-111_d04480a0-2c7a-4370-87a1-f92e13ff78d5 53329-111 HUMAN OTC DRUG Curad Oral Saline Laxative dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20120716 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 2.9; 7.2 g/15mL; g/15mL 53329-138_4bf56f3c-5a61-40ad-97de-bccf65ee952a 53329-138 HUMAN OTC DRUG Remedy with Phytoplex Z-Guard White Petrolatum PASTE TOPICAL 20110801 OTC MONOGRAPH FINAL part347 Medline Industries Inc. PETROLATUM 57 g/100g 53329-139_f830a0e4-dba5-4a5f-af35-3832ec70d4d3 53329-139 HUMAN OTC DRUG Remedy Phytoplex Z-Guard White Petrolatum PASTE TOPICAL 20131217 OTC MONOGRAPH FINAL part347 Medline Industries Inc. PETROLATUM; ZINC OXIDE 57; 17 g/100g; g/100g 53329-140_2d995fbb-5a5d-4236-9679-1c6babd0a969 53329-140 HUMAN OTC DRUG Remedy Skin Repair Dimethicone CREAM TOPICAL 20100301 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 1.5 mL/100mL 53329-141_e998bee2-0416-48ba-ae12-585bc41bc2d9 53329-141 HUMAN OTC DRUG Remedy Cleansing Body Unscented dimethicone LOTION TOPICAL 20080801 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 1.5 mg/100mL 53329-142_22b2d471-80f1-4a1f-ad8b-4aa8691e853b 53329-142 HUMAN OTC DRUG Remedy Dimethicone Moisture Barrier Unscented Dimethicone CREAM TOPICAL 20100301 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 5 g/100mL 53329-143_f16a24f0-cb8a-40d3-929a-c41e829b74bc 53329-143 HUMAN OTC DRUG Remedy Nutrashield Dimethicone CREAM TOPICAL 20100301 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 1 g/100mL 53329-151_ff8ef843-9b5d-44f4-ad63-6a5c43a07753 53329-151 HUMAN OTC DRUG Remedy Dimethicone Moisture Barrier Dimethicone CREAM TOPICAL 20070801 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 5 mL/100mL 53329-157_eb8b7ca2-f32f-483f-bb11-73b41994e834 53329-157 HUMAN OTC DRUG Remedy Nutrashield Dimethicone LOTION TOPICAL 20050601 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 1 mL/100mL 53329-158_afbe947b-d3ce-4ce4-a2af-0c8b90adeda7 53329-158 HUMAN OTC DRUG Remedy Antimicrobial Cleanser benzalkonium chloride SOLUTION TOPICAL 20080801 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .12 mL/100mL 53329-160_fb7a3343-a7b7-4b5b-891b-ec79cccce983 53329-160 HUMAN OTC DRUG Remedy Cleansing Body dimethicone LOTION TOPICAL 20080801 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 1.5 mL/100mL 53329-161_ab5d9249-5a07-4b67-b8df-1e9c86121522 53329-161 HUMAN OTC DRUG Remedy Skin Repair dimethicone CREAM TOPICAL 20080801 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 1.5 mL/100mL 53329-162_e8175c98-6a4e-4a79-b27d-6eb7aa91d9e7 53329-162 HUMAN OTC DRUG Remedy Antifungal With Olivamine Miconazole Nitrate CREAM TOPICAL 20070101 OTC MONOGRAPH FINAL part333C Medline Industries, Inc. MICONAZOLE NITRATE 20 mg/g 53329-164_b5433b37-73c3-455d-9015-62864dae49b1 53329-164 HUMAN OTC DRUG REMEDY Calazime Skin Protectant zinc oxide, menthol PASTE TOPICAL 20080101 20150331 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. MENTHOL; ZINC OXIDE 2; 200 mg/g; mg/g 53329-165_1295cfcc-5b61-481b-964b-f53ffd0cb58e 53329-165 HUMAN OTC DRUG REMEDY Calazime Skin Protectant calamine, menthol, white petrolatum, zinc oxide PASTE TOPICAL 20120323 OTC MONOGRAPH FINAL part346 Medline Industries, Inc. FERRIC OXIDE RED; MENTHOL; PETROLATUM; ZINC OXIDE .5; .2; 69; 19.5 g/100g; g/100g; g/100g; g/100g 53329-166_4e32bf2c-9ba6-4eea-91e6-2ee24126a36b 53329-166 HUMAN OTC DRUG REMEDY Clear-Aid Skin Protectant White Petrolatum OINTMENT TOPICAL 20080301 OTC MONOGRAPH FINAL part347 Medline Industries, Inc PETROLATUM 500 mg/g 53329-167_1072d4d4-e76b-4c77-801d-fd1262fe9d1f 53329-167 HUMAN OTC DRUG Remedy with Phytoplex Antifungal Clear Miconazole Nitrate OINTMENT TOPICAL 20110801 OTC MONOGRAPH FINAL part333C Medline Industries Inc. MICONAZOLE NITRATE 2 g/100g 53329-168_2b51ac9f-c8d1-40c5-a1ab-1c3a0df32b8b 53329-168 HUMAN OTC DRUG Remedy Antifungal Miconazole Nitrate POWDER TOPICAL 20121119 OTC MONOGRAPH FINAL part333C Medline Industries, Inc. MICONAZOLE NITRATE 2 g/100g 53329-169_021b4a31-d7f6-4921-b4b1-cbe832eecd93 53329-169 HUMAN OTC DRUG Remedy Antifungal Miconazole Nitrate POWDER TOPICAL 20121119 OTC MONOGRAPH FINAL part333C Medline Industries, Inc. MICONAZOLE NITRATE 2 g/100g 53329-170_e2674673-b664-4cf9-8b6c-47364633e4fa 53329-170 HUMAN OTC DRUG Remedy Antifungal Targeted Treatment Miconazole Nitrate POWDER TOPICAL 20070101 OTC MONOGRAPH FINAL part333C Medline Industries, Inc. MICONAZOLE NITRATE 20 mg/g 53329-200_cbdd3282-35f3-4d0d-821c-8b61e8019798 53329-200 HUMAN PRESCRIPTION DRUG Zingo lidocaine hydrochloride POWDER INTRADERMAL 20140221 NDA NDA022114 Medline Industries, Inc. LIDOCAINE HYDROCHLORIDE .5 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 53329-203_9f2be060-0699-47ab-9398-efe91eef2267 53329-203 HUMAN OTC DRUG Epi-Clenz Pure Instant Hand Antiseptic ethyl alcohol GEL TOPICAL 20120402 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 70 mL/100mL 53329-204_60fb66ce-b708-4357-aec9-783e6b0b93a9 53329-204 HUMAN OTC DRUG Epi-Clenz Instant Hand Antiseptic ethyl alcohol GEL TOPICAL 20070920 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 70 mL/100mL 53329-205_6026a022-39de-475c-ba7f-dd60b1a651c0 53329-205 HUMAN OTC DRUG Epi-Clenz Instant Hand Antiseptic ethyl alcohol GEL TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 70 mL/100mL 53329-206_14c2c092-e63f-4961-9b7b-ad65256dc0c9 53329-206 HUMAN OTC DRUG Epi-Clenz Instant Hand Antiseptic ethyl alcohol GEL TOPICAL 20070920 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 70 mL/100mL 53329-207_662fe800-c93f-4651-9e84-0759f0ccfaf2 53329-207 HUMAN OTC DRUG Epi-Clenz Instant Hand Antiseptic Scented ethyl alcohol GEL TOPICAL 20070920 OTC MONOGRAPH NOT FINAL part333 Medline Industries, Inc. ALCOHOL 70 mL/100mL 53329-208_d645ab34-1a96-48d1-b9d2-e2dd9e614f78 53329-208 HUMAN OTC DRUG Epi-Clenz Plus Instant Hand Antiseptic ethyl alcohol LOTION TOPICAL 20070920 OTC MONOGRAPH NOT FINAL part333 Medline Industries, Inc. ALCOHOL 62 mL/100mL 53329-210_424e76d0-fa38-4b0c-a29a-c6aae3143876 53329-210 HUMAN OTC DRUG Epi-Clenz Plus Instant Hand Sanitizer ethyl alcohol CLOTH TOPICAL 20070301 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 65 mL/1 53329-211_a46fe64f-cf80-44cf-b817-a07d85c7cdc7 53329-211 HUMAN OTC DRUG Epi-Clenz Instant Hand Antiseptic ethyl alcohol GEL TOPICAL 20070920 OTC MONOGRAPH NOT FINAL part356 Medline Industries, Inc. ALCOHOL 70 mL/100mL 53329-212_680e2251-2cb9-434d-b6ff-1182e389acb0 53329-212 HUMAN OTC DRUG Epi-Clenz Instant Hand Antiseptic ethyl alcohol GEL TOPICAL 20130930 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 70 mL/100mL 53329-301_c65a8d89-4e30-4186-bc20-d6ef54c0757d 53329-301 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20100805 ANDA ANDA077789 Medline Industries, Inc. CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] 53329-302_0ec52309-642f-4667-9199-6711190fa1d4 53329-302 HUMAN OTC DRUG Remedy Skin Protectant White Petrolatum PASTE TOPICAL 20131106 OTC MONOGRAPH FINAL part347 Medline Industries Inc. PETROLATUM 59 g/100g 53329-303_4577a053-3837-412f-a784-ed86a7cccc59 53329-303 HUMAN OTC DRUG Soothe and Cool Moisture Guard White Petrolatum PASTE TOPICAL 20131106 OTC MONOGRAPH FINAL part347 Medline Industries Inc. PETROLATUM 59 g/100g 53329-304_1b7504e8-ba58-4f2f-832e-0d82afc48a94 53329-304 HUMAN OTC DRUG Dignity Antibacterial TRICLOSAN SOAP TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. TRICLOSAN .3 g/100g 53329-410_a925113e-347e-4051-b092-f947b8252d74 53329-410 HUMAN OTC DRUG MediPlast salicylic acid PLASTER TOPICAL 20080801 OTC MONOGRAPH FINAL part358F Medline Industries, Inc SALICYLIC ACID 40 g/100g 53329-640_fb6b9d35-15fb-42cd-937c-fa2f866f1896 53329-640 HUMAN OTC DRUG Medline Acetaminophen Acetaminophen TABLET ORAL 20131226 OTC MONOGRAPH NOT FINAL part343 Medline Industries, Inc. ACETAMINOPHEN 500 mg/1 53329-641_05c06abd-bc0e-447a-ab24-5ba93e81cb59 53329-641 HUMAN OTC DRUG Medline Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131226 OTC MONOGRAPH NOT FINAL part343 Medline Industries, Inc. ACETAMINOPHEN 500 mg/1 53329-642_46175721-4cf7-42d0-8ef0-2d51d695a49e 53329-642 HUMAN OTC DRUG Medline Acetaminophen Acetaminophen TABLET ORAL 20131226 OTC MONOGRAPH NOT FINAL part343 Medline Industries, Inc. ACETAMINOPHEN 325 mg/1 53329-643_2de79711-ea0d-4c21-8cca-f90f3904f91b 53329-643 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Medline Industries, Inc. ACETAMINOPHEN 650 mg/1 53329-650_9788e4ad-bfc8-4256-88bd-8fa5a85af032 53329-650 HUMAN OTC DRUG Diphenhydramine HCl Allergy Antihistamine Diphenhydramine HCl TABLET ORAL 20130330 OTC MONOGRAPH FINAL part336 Medline Industries DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 53329-651_8012abf1-23da-4d42-8fb2-b6def38c1c74 53329-651 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Medline Industries, Inc. LORATADINE 10 mg/1 53329-652_042d252c-843d-4329-8484-97e6e1423d03 53329-652 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Medline Industries, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 53329-664_ec51684e-1aa4-47d4-a2a0-5f5306578ef6 53329-664 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Medline Industries, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 53329-671_ebfef89a-5117-4993-9e7e-0f6baff53453 53329-671 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20130430 ANDA ANDA079096 Medline Industries NAPROXEN SODIUM 220 mg/1 53329-673_5b012afe-9028-43c3-923f-2e1d993e3515 53329-673 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20130115 ANDA ANDA079174 Medline Industries IBUPROFEN 200 mg/1 53329-675_1ffd186b-7380-4e17-919e-2352d112bd30 53329-675 HUMAN OTC DRUG Naproxen NAPROXEN SODIUM TABLET ORAL 20020726 NDA NDA020204 Medline Industries, Inc. NAPROXEN SODIUM 220 mg/1 53329-676_917fa26b-8f21-49d6-a3b3-57b690238e99 53329-676 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20140908 ANDA ANDA079174 Medline industries, Inc. IBUPROFEN 200 mg/1 53329-680_067bc871-a51e-4543-89e3-eb8d2e634917 53329-680 HUMAN OTC DRUG Natural Vegetable Laxative with Stool Softener docusate sodium and sennosides TABLET ORAL 20130430 OTC MONOGRAPH NOT FINAL part334 Medline Industries DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 53329-681_8b13f99b-22fe-4fca-be56-cafb1bb6a7d9 53329-681 HUMAN OTC DRUG Sennosides SENNOSIDES TABLET ORAL 20130330 OTC MONOGRAPH NOT FINAL part334 Medline Industries SENNOSIDES 8.6 mg/1 53329-695_92f91121-229b-4942-b6d6-3d969c23a8fa 53329-695 HUMAN OTC DRUG Ranitidine Ranitidine TABLET ORAL 20120330 ANDA ANDA200536 Medline Industries, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 53329-777_2ea0be6a-3e09-46f7-873e-35d57f4d643e 53329-777 HUMAN OTC DRUG Soothe and Cool INZO Barrier Dimethicone CREAM TOPICAL 20090401 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 5 g/100mL 53329-800_52a8b96e-dd4f-449e-b819-6f3ec5a27fb4 53329-800 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090216 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-801_e0294618-9560-41e9-a2ea-8b3a03532150 53329-801 HUMAN OTC DRUG Medline Alcohol Prep Non-Sterile, Large Isopropyl Alcohol SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-804_e903ecdc-087c-4ad6-9c4d-17bcbbf6aa8e 53329-804 HUMAN OTC DRUG CURAD Isopropyl Alcohol isopropyl alcohol LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-805_0b2cc120-80f6-4fc3-97a0-a1c3c66bf1d4 53329-805 HUMAN OTC DRUG Medline Alcohol Prep Sterile, Medium Isopropyl Alcohol SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-806_42896ab1-cbd3-41c4-bdd6-99e6c3991965 53329-806 HUMAN OTC DRUG Alcohol Swabsticks Singles Isopropyl Alcohol SWAB TOPICAL 20070101 20151231 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-807_50a13a09-b04f-4153-b41d-0622e5de1844 53329-807 HUMAN OTC DRUG Medline Alcohol Swabstick Triples Isopropyl Alcohol SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-808_897f7af1-110f-4cc3-b7f2-74e3de92684a 53329-808 HUMAN OTC DRUG Medline Alcohol Prep Non-Sterile, Medium Isopropyl Alcohol SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-809_1a5b74b3-90b2-4e05-942d-537aa623b57b 53329-809 HUMAN OTC DRUG Medline Alcohol Prep Medium Isopropyl Alcohol SWAB TOPICAL 20121207 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-811_83d6b08b-9d2d-4774-bc05-47f1abb9bc84 53329-811 HUMAN OTC DRUG Medline Alcohol Prep Sterile, Large Isopropyl Alcohol SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-813_af10b2fb-f613-48df-9c2d-2304550e7d61 53329-813 HUMAN OTC DRUG Acetone Alcohol Prep Pads Medium Isopropyl Alcohol SWAB TOPICAL 20070101 20171201 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-814_af10b2fb-f613-48df-9c2d-2304550e7d61 53329-814 HUMAN OTC DRUG Acetone Alcohol Swabsticks Singles Isopropyl Alcohol SWAB TOPICAL 20070101 20171201 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-816_13ee1b04-87bb-41d1-a2d1-e81c0d75964e 53329-816 HUMAN OTC DRUG Medline Alcohol Prep Non-Sterile, Thick/Medium Isopropyl Alcohol SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-817_b5e366f5-78d0-4713-ada4-564f71a5ebba 53329-817 HUMAN OTC DRUG Medline Alcohol Prep Non-Sterile, Extra Large Isopropyl Alcohol SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-818_42896ab1-cbd3-41c4-bdd6-99e6c3991965 53329-818 HUMAN OTC DRUG Isopropyl Alcohol Towelette Isopropyl Alcohol SWAB TOPICAL 20070101 20151231 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-819_56d86874-2923-40b7-81d6-1e542e7666ae 53329-819 HUMAN OTC DRUG Caring Alcohol Non-Sterile, Medium Isopropyl Alcohol SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-820_42896ab1-cbd3-41c4-bdd6-99e6c3991965 53329-820 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-821_d08cfdee-4fe7-4482-8e36-8c5111661f7e 53329-821 HUMAN OTC DRUG Curad Alcohol Non-Sterile, Extra Thick Isopropyl Alcohol SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-822_86ded59d-709a-4b70-9916-edbd6b39aa9d 53329-822 HUMAN OTC DRUG Curad Alcohol Sterile, Large Isopropyl Alcohol SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-823_491736d3-9951-4711-a667-9b755001b9dd 53329-823 HUMAN OTC DRUG Curad Alcohol Non-Sterile, Large Isopropyl Alcohol SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-824_90c91e55-3847-4d8b-a99e-27e5b21da0fa 53329-824 HUMAN OTC DRUG Curad Alcohol Non-Sterile, Medium Isopropyl Alcohol SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-826_99bb3b7b-fad4-4338-97a7-d38fdb8c957a 53329-826 HUMAN OTC DRUG Curad Alcohol Sterile, Thick Isopropyl Alcohol SWAB TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-827_1ce3872e-2307-4a38-bd7d-7eb2b226cf3c 53329-827 HUMAN OTC DRUG Curad Alcohol Prep Pads Medium Isopropyl Alcohol SWAB TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 53329-875_5dfdd793-685a-4374-a84d-69b067f11306 53329-875 HUMAN OTC DRUG CURAD Isopropyl Alcohol isopropyl alcohol LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 91 mL/100mL 53329-901_d36ff1e8-1e52-40a4-a276-f6258c174107 53329-901 HUMAN OTC DRUG Povidone-Iodine Prep Povidone Iodine SOLUTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. POVIDONE-IODINE .1 mL/mL 53329-902_a32b8267-7575-4d13-8bec-1051392038cb 53329-902 HUMAN OTC DRUG Scrub Antiseptic Povidone-Iodine SOLUTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE .075 mL/mL 53329-905_a32b8267-7575-4d13-8bec-1051392038cb 53329-905 HUMAN OTC DRUG Scrub Antiseptic with Spray Bottle Povidone-Iodine SOLUTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE .075 mL/mL 53329-920_70f806e7-0cda-4158-b9c8-3816e9925180 53329-920 HUMAN OTC DRUG Scrub-In Surgical Scrub Brush/Sponge Povidone-Iodine SOLUTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE 9 mg/100mL 53329-921_70f806e7-0cda-4158-b9c8-3816e9925180 53329-921 HUMAN OTC DRUG Scrub-In Surgical Scrub Brush/Sponge Povidone-Iodine SOLUTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE 15 mg/100mL 53329-923_a95cc407-07f9-418e-bd38-b6d567c0cd30 53329-923 HUMAN OTC DRUG Scrub-In Surgical Scrub Brush/Sponge Chloroxylenol SOLUTION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. CHLOROXYLENOL 3.3 mg/100mL 53329-924_a95cc407-07f9-418e-bd38-b6d567c0cd30 53329-924 HUMAN OTC DRUG Scrub-In Surgical Scrub Brush/Sponge Chloroxylenol SOLUTION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. CHLOROXYLENOL 4 mg/100mL 53329-929_b561db62-51bc-49f6-960f-7fdd252906db 53329-929 HUMAN OTC DRUG Antiseptic Towelettes Benzalkonium Chloride CLOTH TOPICAL 20070101 20170831 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .13 mg/100mL 53329-930_3dbdd54e-7a8c-44ef-9a81-d224a3f23fda 53329-930 HUMAN OTC DRUG Kool and Kleen Antiseptic Towelette Benzalkonium Chloride CLOTH TOPICAL 20070101 20170831 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .13 mg/100mL 53329-931_385908e7-1a09-487e-8970-a2a39687d403 53329-931 HUMAN OTC DRUG Benzalkonium Chloride Towelette Benzalkonium Chloride CLOTH TOPICAL 20070101 20170831 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .04 mg/100mL 53329-933_b563d52f-825e-4429-b11a-939b4764d4ea 53329-933 HUMAN OTC DRUG Obstetrical Antiseptic Towelettes Benzalkonium Chloride CLOTH TOPICAL 20070101 20150831 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. BENZALKONIUM CHLORIDE .04 mg/100mL 53329-938_a32b8267-7575-4d13-8bec-1051392038cb 53329-938 HUMAN OTC DRUG Scrub Antiseptic Povidone-Iodine SOLUTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE .075 mL/mL 53329-939_58a737f3-a0d8-474f-b462-437360836e26 53329-939 HUMAN OTC DRUG Povidone-Iodine Topical Antiseptic Povidone-Iodine SOLUTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE 100 mg/mL 53329-940_58a737f3-a0d8-474f-b462-437360836e26 53329-940 HUMAN OTC DRUG Povidone-Iodine Prep Pads Medium Bulk Povidone-Iodine SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE .1 mL/1 53329-941_58a737f3-a0d8-474f-b462-437360836e26 53329-941 HUMAN OTC DRUG Povidone-Iodine Prep Pads Medium Povidone-Iodine SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE .1 mL/1 53329-945_58a737f3-a0d8-474f-b462-437360836e26 53329-945 HUMAN OTC DRUG Povidone-Iodine Swabsticks Singles Povidone-Iodine SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE .1 mL/1 53329-946_58a737f3-a0d8-474f-b462-437360836e26 53329-946 HUMAN OTC DRUG Povidone-Iodine Swabsticks Triples Povidone-Iodine SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE .1 mL/1 53329-947_4bed222c-677b-48d6-a191-6ad542479c5c 53329-947 HUMAN OTC DRUG Povidone-Iodine Scrub Solution Swabsticks Triples Povidone Iodine SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE .07 mL/1 53329-948_4bed222c-677b-48d6-a191-6ad542479c5c 53329-948 HUMAN OTC DRUG Povidone-Iodine Scrub Solution Swabsticks Singles Povidone Iodine SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE .07 mL/1 53329-962_8155f550-f6be-48b8-90a5-30108bebb618 53329-962 HUMAN OTC DRUG Epi-Clenz Plus Instant Hand Antiseptic ethyl alcohol LOTION TOPICAL 20070920 OTC MONOGRAPH NOT FINAL part333 Medline Industries, Inc. ALCOHOL 62 mL/100mL 53329-970_a80c1d3b-1c32-4cbd-861b-4407e4e3e5ea 53329-970 HUMAN OTC DRUG Epi-Clenz Instant Hand Antiseptic ethyl alcohol AEROSOL, FOAM TOPICAL 20051230 OTC MONOGRAPH NOT FINAL part333 Medline Industries, Inc. ALCOHOL 62 mL/100mL 53329-975_7de013e4-d6b3-4aea-a753-d7f6cd3e8de4 53329-975 HUMAN OTC DRUG Skintegrity Foaming Hand Sanitizer Fragrance Free Ethyl Alcohol SOLUTION TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 62 mL/100mL 53329-976_3637818b-8eca-4a32-ac15-f116c1aaae52 53329-976 HUMAN OTC DRUG Skintegrity Foaming Hand Sanitizer Alcohol Free Benzethonium Chloride SOLUTION TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. BENZETHONIUM CHLORIDE .2 mL/100mL 53329-977_864262de-e2a2-435f-82fa-e81c9854ee70 53329-977 HUMAN OTC DRUG Skintegrity Antibacterial Hand Foaming with Skin Conditioners Triclosan SOAP TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. TRICLOSAN .5 mL/100mL 53329-978_8c01bcd8-6beb-4940-b5b3-02c3dec43cc1 53329-978 HUMAN OTC DRUG Skintegrity Antibacterial Hand Foaming Triclosan SOAP TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. TRICLOSAN .5 mL/100mL 53329-981_c0e8220e-3d9d-437e-9914-7c294988e2ea 53329-981 HUMAN OTC DRUG Hydrogen Peroxide First Aid Antiseptic Hydrogen Peroxide LIQUID TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. HYDROGEN PEROXIDE 3 mL/100mL 53329-982_c0e8220e-3d9d-437e-9914-7c294988e2ea 53329-982 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. HYDROGEN PEROXIDE 3 mL/100mL 53329-983_0bf4c68b-9244-4a1d-9555-04a07e3f8467 53329-983 HUMAN OTC DRUG CURAD Hydrogen Peroxide hydrogen peroxide LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. HYDROGEN PEROXIDE 3 mL/100mL 53341-056_01625d08-5cfd-45de-ac14-d3e6e637ed5e 53341-056 HUMAN OTC DRUG Instant Hand Sanitizer (Gel-Type) Instant Hand Sanitizer (Gel-Type) SOLUTION TOPICAL 20131105 OTC MONOGRAPH NOT FINAL part333A Tranzonic Companies ALCOHOL 62 mL/100mL 53341-515_fb93afea-40f3-4ac8-9ce9-e595431c20ed 53341-515 HUMAN OTC DRUG Global Clean Instant Hand Sanitizer alcohol GEL TOPICAL 19981028 OTC MONOGRAPH NOT FINAL part333E Tranzonic Companies ALCOHOL 600 mL/1000mL 53345-002_035f4757-0d2d-4cab-a7bc-ec9a12fd6a29 53345-002 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH FINAL part338 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 53345-003_720c5558-89bb-45d7-9e31-ce24a988e782 53345-003 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone 180 mg CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH FINAL part332 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DIMETHICONE 410 180 mg/1 53345-004_0b0e4538-4263-4241-b420-c5b60b2c54c0 53345-004 HUMAN OTC DRUG DayTime Cold and Flu acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20130615 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 53345-005_8e586ebe-c908-4908-a46a-906add065e9e 53345-005 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH FINAL part338 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 53345-006_bb21cc5e-e5c6-44ea-b95e-0be0f0d48e8f 53345-006 HUMAN OTC DRUG Nighttime Cold and Flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 53345-007_e2b8ccab-60ce-4044-8c14-0f46fe432527 53345-007 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20130915 OTC MONOGRAPH FINAL part336 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 53345-008_a65a5c04-1a44-4702-be30-7e81dbc705e9 53345-008 HUMAN OTC DRUG DOCUSATE SODIUM DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH NOT FINAL part334 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DOCUSATE SODIUM 100 mg/1 53345-009_3a7df54c-b70a-4bce-8f0f-1a3974380537 53345-009 HUMAN OTC DRUG Simethicone Simethicone CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH FINAL part332 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DIMETHICONE 125 mg/1 53345-010_a0f00ba0-1233-42d2-bf86-4f656c54c21a 53345-010 HUMAN OTC DRUG ACETAMINOPHEN (RED) ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH NOT FINAL part343 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN 325 mg/1 53345-011_f90fb4b0-b2aa-4ba1-ae70-53a0a605b760 53345-011 HUMAN OTC DRUG Dextromethorphan HBr 15 mg Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20140130 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 53345-012_16f8c0c3-70c1-4836-b6fd-9e2986531c3c 53345-012 HUMAN OTC DRUG DayTime Sinus Relief acetaminophen, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20130615 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 53345-013_3f2c8791-6ee2-47a4-a4c0-955f8c985b68 53345-013 HUMAN OTC DRUG NightTime Sinus Relief Acetaminophen, Doxylamine succinate, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20130615 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 53345-015_61eeb288-b60a-4e20-8bd7-487b26df00f2 53345-015 HUMAN OTC DRUG DOCUSATE SODIUM 50 MG DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131112 OTC MONOGRAPH NOT FINAL part334 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DOCUSATE SODIUM 50 mg/1 53345-018_d7faf888-56e2-41b3-8442-c024f572725c 53345-018 HUMAN OTC DRUG DOCUSATE SODIUM 100mg Two-Tone DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131223 OTC MONOGRAPH NOT FINAL part334 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DOCUSATE SODIUM 100 mg/1 53345-019_67ef9fe9-4816-445a-bf48-5a9c5f2d764a 53345-019 HUMAN OTC DRUG Pain Relief Extra Strength ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20140106 OTC MONOGRAPH NOT FINAL part343 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN 500 mg/1 53345-020_42e74b5b-7b7b-4129-9158-17d06f5b075d 53345-020 HUMAN OTC DRUG Night Cold Flu Cough and Allergy acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20130529 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 53345-021_45ba88c1-bcb8-4f2f-a088-e2c58f42ef1e 53345-021 HUMAN OTC DRUG Daytime Severe Cold and Flu acetaminophen, dextromethorphan hydrobromide, Guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20140711 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 53345-022_fb017820-528e-428e-94ed-e686fd7b8809 53345-022 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140813 OTC MONOGRAPH FINAL part338 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 53345-023_c738990b-fc78-4f71-b965-78f9cb8277d9 53345-023 HUMAN OTC DRUG DOCUSATE SODIUM 100mg Two-Tone DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140811 OTC MONOGRAPH NOT FINAL part334 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DOCUSATE SODIUM 100 mg/1 53345-025_47a55c86-d377-4dc8-9729-47937a255984 53345-025 HUMAN OTC DRUG DayTime Cold and Flu acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20140811 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 53345-026_1cb03e64-8432-42f7-ac4d-9c134614b369 53345-026 HUMAN OTC DRUG Nighttime Cold and Flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20140811 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 53345-027_c1fcb444-588c-4e60-832a-008d1b7eda46 53345-027 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20141014 OTC MONOGRAPH FINAL part338 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 53345-028_43b370cb-1096-4e64-ac31-7e41046a48b3 53345-028 HUMAN OTC DRUG Dextromethorphan HBr 15 mg Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20141210 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 53346-0515_c1ed5356-714f-418f-89f9-36bb4093f8df 53346-0515 HUMAN OTC DRUG DR. RECKEWEG v-C15 Homeopathic preparation Cocculus indicus 5X, Helonias dioica 5X, Ignatia amara 5X, Phosphoricum acidum 3X, Sepia 6X, Zincum metallicum 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ANAMIRTA COCCULUS SEED; CHAMAELIRIUM LUTEUM ROOT; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; ZINC 5; 5; 3; 6; 5; 6 [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL 53346-1201_ba5c13d5-6bd5-4571-b316-e046ab03a2b8 53346-1201 HUMAN OTC DRUG DR RECKEWEG BC-1 Combination Salt CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, NATRUM MURIATICUM TABLET ORAL 20120101 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; TRIBASIC CALCIUM PHOSPHATE 3; 3; 6; 3 [hp_X]/20g; [hp_X]/20g; [hp_X]/20g; [hp_X]/20g 53346-1301_fa3ddce8-4c81-44d6-b6fb-24a205b2f5cc 53346-1301 HUMAN OTC DRUG DR. RECKEWEG R1 Anginacid Combination Product Apis mellifica 4X, Baryta muriatica 6X, Belladonna 4X, Calcarea iodata 4X, Hepar sulphuris calcareum 12X, Kali bichromicum 4X, Lachesis mutus 12X, Teucrium marum 6X, Mercurius corrosivus 6X, Phytolacca decandra 4X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO APIS MELLIFERA; ATROPA BELLADONNA; BARIUM CHLORIDE DIHYDRATE; CALCIUM IODIDE; CALCIUM SULFIDE; LACHESIS MUTA VENOM; MERCURIC CHLORIDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; TEUCRIUM MARUM 4; 4; 6; 4; 12; 12; 6; 4; 4; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1304_b8455c48-a727-4a2e-8e62-70affad974e3 53346-1304 HUMAN OTC DRUG DR. RECKEWEG R4 Enterocolin Combination Product Baptisia tinctoria 4X, Chamomilla 4X, Chininum arsenicosum 6X, Colocynthis 6X, Ferrum phosphoricum 8X, Mercurius corrosivus 6X, Oleander 6X, Phosphoricum acidum 3X, Rhus toxicodendron 4X, Veratrum album 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO BAPTISIA TINCTORIA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; FERRIC PHOSPHATE; MATRICARIA RECUTITA; MERCURIC CHLORIDE; NERIUM OLEANDER LEAF; PHOSPHORIC ACID; QUININE ARSENITE; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 4; 6; 8; 4; 6; 6; 3; 6; 4; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1305_aa1a1f3b-38d6-482e-81d5-5a81cc5e2211 53346-1305 HUMAN OTC DRUG Dr. RECKEWEG R5 Gastreu Combination Product Anacardium orientale 6X, Argentum nitricum 6X, Arsenicum album 6X, Belladonna 4X, Carbo vegetabilis 8X, Chamomilla 2X, Chelidonium majus, radix 3X, Lycopodium clavatum 5X, Nux vomica 4X, Scrophularia nodosa 1X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CHELIDONIUM MAJUS ROOT; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; SCROPHULARIA NODOSA; SEMECARPUS ANACARDIUM FRUIT; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED 8; 6; 4; 3; 5; 2; 1; 6; 6; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1306_bebd30cb-67cb-4bd4-89cd-147d1d7b4ec0 53346-1306 HUMAN OTC DRUG Combination Product Aconitum napellus 4X, Baptisia tinctoria 4X, Bryonia 4X, Camphora 3X, Causticum 6X, Eucalyptus globulus 3X, Eupatorium perfoliatum 3X, Ferrum phosphoricum 8X, Gelsemium sempervirens 6X, Sabadilla 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ACONITUM NAPELLUS; BAPTISIA TINCTORIA ROOT; BRYONIA DIOICA ROOT; CAMPHOR (NATURAL); CAUSTICUM; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; SCHOENOCAULON OFFICINALE SEED 4; 4; 4; 3; 6; 3; 3; 8; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1307_e7966e97-7072-42cd-b9ed-491f9e3a5163 53346-1307 HUMAN OTC DRUG DR. RECKEWEG R7 Hepagalen Combination Product Carduus marianus 2X, Chelidonium majus, radix 2X, Cinchona 3X, Cholesterinum 6X, Colocynthis 6X, Lycopodium clavatum 4X, Nux vomica 4X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO CHELIDONIUM MAJUS ROOT; CHOLESTEROL; CINCHONA BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; SILYBUM MARIANUM SEED; STRYCHNOS NUX-VOMICA SEED 2; 6; 3; 6; 4; 2; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1309_e7745d5c-f957-45e3-a9a9-35c4576e027b 53346-1309 HUMAN OTC DRUG DR. RECKEWEG R9 Jutussin Combination Product Belladonna 4X, Bryonia 4X, Coccus cacti 6X, Corallium rubrum 12X, Cuprum aceticum 12X, Drosera 4X, Ipecacuanha 6X, Spongia tosta 6X, Sticta pulmonaria 4X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ATROPA BELLADONNA; BRYONIA DIOICA ROOT; CORALLIUM RUBRUM EXOSKELETON; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPECAC; LOBARIA PULMONARIA; PROTORTONIA CACTI; SPONGIA OFFICINALIS SKELETON, ROASTED 4; 4; 12; 12; 4; 6; 4; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1310_f94cf9a1-c478-496e-adee-54458759ebd2 53346-1310 HUMAN OTC DRUG Dr. Reckeweg R10 Klimakteran Combination Product Cimicifuga racemosa 6X, Lachesis mutus 12X, Sanguinaria canadensis 6X, Sepia 6X, Sulfuricum acidum 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO BLACK COHOSH; LACHESIS MUTA VENOM; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SULFURIC ACID 6; 12; 6; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1311_b5f52b48-748e-492b-8839-aecea0d6c5bc 53346-1311 HUMAN OTC DRUG DR. RECKEWEG R11 Lumbagin Combination Product Berberis vulgaris 4X, Calcarea phosphorica 12X, Causticum 6X, Dulcamara 4X, Nux vomica 4X, Rhododendron chrysanthum 4X, Rhus toxicodendron 4X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO BERBERIS VULGARIS ROOT BARK; CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE; CAUSTICUM; RHODODENDRON AUREUM LEAF; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 4; 12; 6; 4; 4; 4; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1313_e002f75e-45f8-4b61-8772-0c3d10627e80 53346-1313 HUMAN OTC DRUG DR. RECKEWEG R13 Prohaemorrhin Combination Product Aesculus hippocastanum 2X, Collinsonia canadensis 4X, Graphites 8X, Hamamelis virginiana 3X, Kali carbonicum 6X, Lycopodium clavatum 5X, Nitricum acidum 6X, Nux vomica 4X, Paeonia officinalis 3X, Sulphur 5X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO COLLINSONIA CANADENSIS ROOT; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PAEONIA OFFICINALIS ROOT; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SULFUR 4; 8; 3; 2; 5; 6; 3; 6; 4; 5 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1314_b3f078a8-34d3-4202-8f73-7450a1b31fd6 53346-1314 HUMAN OTC DRUG DR. RECKEWEG R14 Quieta Combination Product Ammonium bromatum 3X, Avena sativa 1X, Chamomilla 4X, Coffea cruda 4X, Eschscholtzia californica 2X, Humulus lupulus 2X, Ignatia amara 6X, Passiflora incarnata 2X, Valeriana officinalis 1X, Zincum valerianicum 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO AMMONIUM BROMIDE; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; ESCHSCHOLZIA CALIFORNICA FLOWERING TOP; HOPS; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS IGNATII SEED; VALERIAN; ZINC VALERATE DIHYDRATE 3; 4; 1; 2; 2; 4; 2; 6; 1; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1316_ae122ddf-a5ea-4887-b6e6-f4393160b430 53346-1316 HUMAN OTC DRUG DR. RECKEWEG R16 Cimisan Combination Product Cimicifuga racemosa 4X, Gelsemium sempervirens 3X, Iris versicolor 2X, Sanguinaria canadensis 3X, Spigelia anthelmia 4X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA 4; 3; 2; 3; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1317_ca3e89de-3292-4451-98b8-9dc86233ecf5 53346-1317 HUMAN OTC DRUG DR. RECKEWEG R17 Cobralactin Combination Product Lacticum acidum 4X, Naja tripudians 8X, Scrophularia nodosa 2X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO LACTIC ACID, DL-; NAJA NAJA VENOM; SCROPHULARIA NODOSA 4; 8; 2 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1318_a3569fae-a569-4a80-859c-365731bec440 53346-1318 HUMAN OTC DRUG DR. RECKEWEG R18 Cystophylin Combination Product Berberis vulgaris 4X, Cantharis 4X, Dulcamara 4X, Equisetum hyemale 6X, Eupatorium purpureum 3X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO BERBERIS VULGARIS ROOT BARK; EQUISETUM HYEMALE; EUTROCHIUM PURPUREUM ROOT; LYTTA VESICATORIA; SOLANUM DULCAMARA TOP 4; 6; 3; 4; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1323_c052dd9d-f6d4-4f5c-beba-dc302388bc98 53346-1323 HUMAN OTC DRUG DR. RECKEWEG R23 Nosoderm Combination Product Apis mellifica 30X, Arsenicum album 30X, Rhus toxicodendron 30X, Sulphur 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO APIS MELLIFERA; ARSENIC TRIOXIDE; SULFUR; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1325_e7b47449-855c-40f0-8f6d-3fb7d7e04d14 53346-1325 HUMAN OTC DRUG DR. RECKEWEG R25 Prostatan Combination Product Chimaphila umbellata 6X, Conium maculatum 6X, Ferrum picricum 6X, Pareira brava 6X, Populus tremuloides 6X, Pulsatilla 6X, Sabal serrulata 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO CHIMAPHILA UMBELLATA; CHONDRODENDRON TOMENTOSUM ROOT; CONIUM MACULATUM FLOWERING TOP; FERRIC PICRATE; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; PULSATILLA PRATENSIS; SAW PALMETTO 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1326_ea9f5f40-ae06-407a-9359-a05878339e72 53346-1326 HUMAN OTC DRUG DR. RECKEWEG R26 Remisin Combination Product Calcarea iodata 12X, Ferrum iodatum 12X, Nitricum acidum 12X, Phosphoricum acidum 12X, Sulphur iodatum 12X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO CALCIUM IODIDE; FERROUS IODIDE; NITRIC ACID; PHOSPHORIC ACID; SULFUR IODIDE 12; 12; 12; 12; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1327_ca9cff7d-d994-4b28-b284-1dd9f68e9eda 53346-1327 HUMAN OTC DRUG DR. RECKEWEG R27 Renocalcin Combination Product Berberis vulgaris 3X, Lycopodium clavatum 5X, Nitricum acidum 6X, Sarsaparilla 3X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO BERBERIS VULGARIS ROOT BARK; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; SMILAX REGELII ROOT 3; 5; 6; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1329_ab8af42c-ca8a-458f-9958-6a380fe8ab9a 53346-1329 HUMAN OTC DRUG DR. RECKEWEG R29 Theridon Combination Product Argentum nitricum 30X, Cocculus indicus 30X, Conium maculatum 30X, Theridion 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; SILVER NITRATE; THERIDION CURASSAVICUM 30; 30; 30; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1330_ec13cadd-84f7-49bf-af16-ffc2f6a8f731 53346-1330 HUMAN OTC DRUG DR. RECKEWEG R30 Atomare Beckeron Pain relieving cream Camphora 3X, Arnica montana, radix 3X, Belladonna 3X, Calendula officinalis 3X, Dulcamara 3X, Echinacea 3X, Hamamelis virginiana 3X, Hypericum perforatum 3X, Millefolium 3X, Nux vomica 4X, Rhus toxicodendron 3X OINTMENT TOPICAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ACHILLEA MILLEFOLIUM; ARNICA MONTANA ROOT; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; CAMPHOR (NATURAL); ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 3; 3; 3; 3; 3; 3; 4; 3 [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g 53346-1334_b3d3c578-4872-4a94-80e1-bcaf42087ed9 53346-1334 HUMAN OTC DRUG DR. RECKEWEG R34 Calcossin Combination Product Calcarea carbonica 30X, Calcarea fluorica 12X, Calcarea hypophosphorosa 6X, Calcarea phosphorica 12X, Chamomilla 6X, Hekla Lava 12X, Mercurius praecipitatus ruber 12X, Mezereum 6X, Silicea 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO CALCIUM FLUORIDE; CALCIUM HYPOPHOSPHITE; CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE; DAPHNE MEZEREUM BARK; HEKLA LAVA; MATRICARIA RECUTITA; MERCURIC OXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE 12; 6; 12; 6; 12; 6; 12; 30; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1335_af0d4920-b8b7-49f1-a16d-18a77032ea1b 53346-1335 HUMAN OTC DRUG DR. RECKEWEG R35 Chadontin Combination Product Aconitum napellus 6X, Bryonia 30X, Calcarea carbonica 30X, Chamomilla 4X, Colocynthis 12X, Ignatia amara 30X, Staphysagria 8X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ACONITUM NAPELLUS; BRYONIA DIOICA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; DELPHINIUM STAPHISAGRIA SEED; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED 6; 30; 12; 8; 4; 30; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1337_c6d67ab3-1dfb-47b9-ab30-98b3daa41391 53346-1337 HUMAN OTC DRUG DR. RECKEWEG R37 Colinteston Combination Product Alumina 12X, Bryonia 4X, Colocynthis 4X, Lachesis mutus 30X, Lycopodium clavatum 4X, Mercurius corrosivus 8X, Nux vomica 6X, Plumbum aceticum 12X, Sulphur 12X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ALUMINUM OXIDE; BRYONIA DIOICA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; LACHESIS MUTA VENOM; LEAD ACETATE; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 4; 4; 30; 12; 4; 8; 6; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1340_df73a82e-a5b5-4ef7-bf7a-7d1cf56eeb8e 53346-1340 HUMAN OTC DRUG DR. RECKEWEG R40 Diaglukon Combination product Arsenicum album 8X, Lycopodium clavatum 30X, Natrum sulphuricum 12X, Phosphoricum acidum 12X, Secale cornutum 4X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ARSENIC TRIOXIDE; CLAVICEPS PURPUREA SCLEROTIUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SODIUM SULFATE 8; 4; 30; 12; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1343_db7bf774-b2db-4786-a3f1-cddb90f3fa63 53346-1343 HUMAN OTC DRUG DR. RECKEWEG R43 Herbamine Combination product Arsenicum album 8X, Belladonna 30X, Bryonia 12X, Carbo vegetabilis 30X, Eriodictyon californicum 12X, Hypophysis suis 30X, Kali phosphoricum 30X, Natrum muriaticum 30X, Natrum sulphuricum 200X, Veratrum album 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA DIOICA ROOT; ERIODICTYON CALIFORNICUM FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM SULFATE; SUS SCROFA PITUITARY GLAND; VERATRUM ALBUM ROOT 30; 8; 30; 12; 12; 30; 30; 200; 30; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1345_a8eabc6f-e7d0-47f7-8dcb-4e06d3ab1b81 53346-1345 HUMAN OTC DRUG DR. RECKEWEG R45 Laryngin Combination product Argentum nitricum 12X, Arnica montana, radix 30X, Arum maculatum 12X, Calcarea carbonica 30X, Phosphorus 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ARNICA MONTANA ROOT; ARUM MACULATUM ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SILVER NITRATE 30; 12; 30; 30; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1346_c2f002cc-8b0b-42c4-9173-c6c48b196fb8 53346-1346 HUMAN OTC DRUG DR. RECKEWEG R46 Manurheumin Combination product Ferrum phosphoricum 12X, Lithium carbonicum 12X, Natrum sulphuricum 30X, Nux vomica 30X, Rhododendron chrysanthum 6X, Spiraea ulmaria 12X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO FERRIC PHOSPHATE; FILIPENDULA ULMARIA ROOT; LITHIUM CARBONATE; RHODODENDRON AUREUM LEAF; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED 12; 12; 12; 6; 30; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1347_e81995e6-218a-42e3-8ad8-446f5c3b8fd5 53346-1347 HUMAN OTC DRUG DR. RECKEWEG R47 Neuroglobin Combination product Asafoetida 12X, Coffea cruda 30X, Glonoinum 12X, Ignatia amara 30X, Lachesis mutus 30X, Moschus 12X, Pulsatilla 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ARABICA COFFEE BEAN; ASAFETIDA; LACHESIS MUTA VENOM; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; NITROGLYCERIN; PULSATILLA PRATENSIS; STRYCHNOS IGNATII SEED 30; 12; 30; 12; 12; 30; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1349_ad06cbb6-6070-4e4a-9db1-31cd14789676 53346-1349 HUMAN OTC DRUG DR. RECKEWEG R49 Rhinopulsan Combination product Arsenicum album 12X, Calcarea carbonica 30X, Kali bichromicum 12X, Mercurius solubilis 30X, Mercurius sulphuratus ruber 12X, Pulsatilla 12X, Sepia 12X, Sulphur 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ARSENIC TRIOXIDE; MERCURIC SULFIDE; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS; SEPIA OFFICINALIS JUICE; SULFUR 12; 12; 30; 30; 12; 12; 12; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1351_a4efbb03-6b76-43e1-b48f-3dad6098b9c9 53346-1351 HUMAN OTC DRUG DR. RECKEWEG R51 Thyreosan Combination product Belladonna 30X, Hekla Lava 12X, Iodium 30X, Lapis albus 12X, Lycopus virginicus 12X, Natrum muriaticum 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ATROPA BELLADONNA; CALCIUM HEXAFLUOROSILICATE; HEKLA LAVA; IODINE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE 30; 12; 12; 30; 12; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1353_a8d4f9f4-d892-451e-bfee-362998860c2d 53346-1353 HUMAN OTC DRUG DR. RECKEWEG R53 Comedonin Combination product Ammonium bromatum 12X, Bromium 12X, Hepar sulphuris calcareum 30X, Juglans regia 30X, Kali bromatum 12X, Ledum palustre 30X, Natrum bromatum 12X, Natrum muriaticum 200X, Placenta suis 12X, Viola tricolor 12X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO AMMONIUM BROMIDE; BROMINE; CALCIUM SULFIDE; ENGLISH WALNUT; LEDUM PALUSTRE TWIG; POTASSIUM BROMIDE; SODIUM BROMIDE; SODIUM CHLORIDE; SUS SCROFA PLACENTA; VIOLA TRICOLOR 12; 12; 30; 30; 30; 12; 12; 200; 12; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1355_cf19a354-66ec-4bbc-97af-7ee3e8786c65 53346-1355 HUMAN OTC DRUG DR. RECKEWEG R55 Rutavine Combination product Arnica montana, radix 3X, Belladonna 4X, Calendula officinalis 3X, Echinacea 3X, Hamamelis virginiana 4X, Rhus toxicodendron 6X, Ruta graveolens 6X, Symphytum officinale 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ARNICA MONTANA ROOT; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 3; 4; 3; 6; 3; 4; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1359_f531edcf-42bc-4af6-a613-74622bbab093 53346-1359 HUMAN OTC DRUG DR. RECKEWEG R59 Vesiculine Combination product Calcarea carbonica 12X, Fucus vesiculosus 4X, Graphites 12X, Natrum sulphuricum 4X, Spongia tosta 4X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO FUCUS VESICULOSUS; GRAPHITE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED 4; 12; 12; 4; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1360_e64648de-3e94-4547-a3c0-da755755033b 53346-1360 HUMAN OTC DRUG DR. RECKEWEG R60 Purhaemine Combination product Aranea diadema 12X, Conium maculatum 30X, Fumaria officinalis 6X, Galium aparine 12X, Hepar sulphuris calcareum 12X, Juglans regia 6X, Myosotis arvensis 6X, Sarsaparilla 6X, Scrophularia nodosa 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ARANEUS DIADEMATUS; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; ENGLISH WALNUT; FUMARIA OFFICINALIS FLOWERING TOP; GALIUM APARINE; MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; SMILAX REGELII ROOT 12; 12; 30; 6; 6; 12; 6; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1363_d858c247-2068-4e99-be9a-7a2cb1ed9e8f 53346-1363 HUMAN OTC DRUG DR. RECKEWEG R63 Endangitin Combination product Aesculus hippocastanum 2X, Potentilla anserina 2X, Cuprum aceticum 6X, Secale cornutum 4X, Tabacum 4X, Veratrum album 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO CLAVICEPS PURPUREA SCLEROTIUM; CUPRIC ACETATE; HORSE CHESTNUT; POTENTILLA ANSERINA FLOWERING TOP; TOBACCO LEAF; VERATRUM ALBUM ROOT 4; 6; 2; 2; 4; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1365_cabf7ad1-d5ce-43d6-a802-24e462b7379a 53346-1365 HUMAN OTC DRUG DR. RECKEWEG R65 Psoriasin Combination Product Berberis aquifolium 4X, Hydrocotyle asiatica 4X, Arsenicum album 12X, Calcarea carbonica 30X, Graphites 12X, Natrum muriaticum 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ARSENIC TRIOXIDE; CENTELLA ASIATICA; GRAPHITE; MAHONIA AQUIFOLIUM WHOLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE 12; 4; 12; 4; 30; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1366_c6d6c6b5-fafb-4b99-b182-15da7bdcf97a 53346-1366 HUMAN OTC DRUG DR. RECKEWEG R66 Arrhythmin Combination product Ammi visnaga 2X, Cytisus scoparius 2X, Leonurus cardiaca 2X, Sumbul 2X, Iberis amara 3X, Oleander 3X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO AMMI VISNAGA FRUIT; CYTISUS SCOPARIUS FLOWERING TOP; FERULA SUMBUL ROOT; IBERIS AMARA SEED; LEONURUS CARDIACA; NERIUM OLEANDER LEAF 2; 2; 2; 3; 2; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1368_abc664bc-f816-4be9-8bce-e1f2ee502407 53346-1368 HUMAN OTC DRUG DR. RECKEWEG R68 Herpezostin Combination product Mezereum 3X, Croton tiglium 6X, Rhus toxicodendron 4X, Natrum muriaticum 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF 6; 3; 6; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1371_f6236ba6-4a87-435e-b50f-836030c265ba 53346-1371 HUMAN OTC DRUG DR. RECKEWEG R71 Ischialgin Combination product Aconitum napellus 4X, Arsenicum album 30X, Colocynthis 4X, Gnaphalium polycephalum 3X, Magnesia phosphorica 8X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ACONITUM NAPELLUS; ARSENIC TRIOXIDE; CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM 4; 30; 4; 8; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1373_bd9bad22-e1d7-439a-83fd-1219b7e6cd87 53346-1373 HUMAN OTC DRUG DR. RECKEWEG R73 Spondarthrin Combination product Arnica montana, radix 4X, Bryonia 4X, Ledum palustre 4X, Sulphuricum acidum 6X, Argentum metallicum 12X, Causticum 12X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ARNICA MONTANA ROOT; BRYONIA DIOICA ROOT; CAUSTICUM; LEDUM PALUSTRE TWIG; SILVER; SULFURIC ACID 4; 4; 12; 4; 12; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1374_e1b68275-cb3c-483b-ad77-f9ef08f6a599 53346-1374 HUMAN OTC DRUG DR. RECKEWEG R74 Nocturnin Combination product Ferrum phosphoricum 8X, Kali phosphoricum 12X, Pulsatilla 12X, Sepia 6X, Calcarea phosphorica 30X, Causticum 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE; CAUSTICUM; FERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA PRATENSIS; SEPIA OFFICINALIS JUICE 30; 30; 8; 12; 12; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1376_a8bc3f20-8639-40d3-8ff1-e3ddc0a0165a 53346-1376 HUMAN OTC DRUG DR. RECKEWEG R76 Herbamine Forte Combination product Drosera 1X, Mentholum 2X, Convallaria majalis 3X, Lobelia inflata 3X, Stramonium 6X, Aconitum napellus 3X, Ammi visnaga 2X, Kali iodatum 3X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ACONITUM NAPELLUS; AMMI VISNAGA FRUIT; CONVALLARIA MAJALIS; DATURA STRAMONIUM; DROSERA ROTUNDIFOLIA; LOBELIA INFLATA; MENTHOL; POTASSIUM IODIDE 3; 2; 3; 6; 1; 3; 2; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-1381_f4b615cb-0f8b-4a37-9f99-b64a9b61edb9 53346-1381 HUMAN OTC DRUG DR. RECKEWEG R81 Maldol Combination product Cyclamen europaeum 4X, Ginkgo biloba 3X, Aranea diadema 4X, Cimicifuga racemosa 4X, Cocculus indicus 4X, Colocynthis 4X, Gelsemium sempervirens 3X, Spigelia anthelmia 4X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ANAMIRTA COCCULUS SEED; ARANEUS DIADEMATUS; BLACK COHOSH; CITRULLUS COLOCYNTHIS FRUIT PULP; CYCLAMEN PURPURASCENS TUBER; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; SPIGELIA ANTHELMIA 4; 4; 4; 4; 4; 3; 3; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53346-8552_e5b01781-7dab-437c-a1d2-ca511ff3dfd5 53346-8552 HUMAN OTC DRUG DR. RECKEWEG R52 Vomisan Combination product Aethusa cynapium 6X, Cocculus indicus 12X, Colchicum autumnale 12X, Ipecacuanha 8X, Nux vomica 30X, Petroleum 12X, Veratrum album 30X LIQUID ORAL 20130702 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO AETHUSA CYNAPIUM; ANAMIRTA COCCULUS SEED; COLCHICUM AUTUMNALE BULB; IPECAC; KEROSENE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 6; 12; 12; 8; 12; 30; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 53360-4142_fecbdf4d-7761-4945-a23c-5edcc2ed0e4d 53360-4142 HUMAN PRESCRIPTION DRUG Multaq dronedarone TABLET, FILM COATED ORAL 20090701 NDA NDA022425 Sanofi Winthrop Industries DRONEDARONE 400 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 53389-000_c48e362d-8c2c-4bf7-b09e-230c946f49ee 53389-000 HUMAN OTC DRUG EROS PLATINUM BODYGLIDE SUPER CONCENTRATED DIMETHICONE GEL TOPICAL 20121101 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL 53389-035_bf897f0b-2187-43ee-8750-b6169a2549c3 53389-035 HUMAN OTC DRUG EROS BODYGLIDE SUPER CONCENTRATED DIMETHICONE GEL TOPICAL 20121001 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL 53389-039_2fb52f26-a68c-4987-a556-cb0e155ecb1d 53389-039 HUMAN OTC DRUG EROS IRON MAN MENTHOL SPRAY TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part348 MEGASOL COSMETIC GMBH MENTHOL 4 g/100mL 53389-046_acbdcb54-c4c2-47b1-ab3e-4979a9b47cb3 53389-046 HUMAN OTC DRUG EROS ANAL EASE GLYCERIN SPRAY TOPICAL 20121001 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL 53389-100_ae44fb1f-7b07-42ea-997c-c84f7ae0c0b0 53389-100 HUMAN OTC DRUG EROS SILICONE GLIDE AND CARE WOMAN DIMETHICONE GEL TOPICAL 20121001 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL 53389-101_025d1b6e-af95-49ce-a5ce-c1a7f5bb87c4 53389-101 HUMAN OTC DRUG EROS AQUA SENSATIONS WATER BASED GLYCERIN GEL TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 5 g/100mL 53389-110_4d726637-95ed-4cbe-b4e1-e9bd5d5cf065 53389-110 HUMAN OTC DRUG M EROS BODYGLIDE .SUPER CONCENTRATED DIMETHICONE GEL TOPICAL 20121201 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL 53389-112_4fe0f87c-92cc-4f6a-b922-51e88d3f54c8 53389-112 HUMAN OTC DRUG EROS BODYGLIDE SUPER CONCENTRATED DIMETHICONE GEL TOPICAL 20121001 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL 53389-113_fc5092a8-5712-4c50-913f-87ebea49a870 53389-113 HUMAN OTC DRUG EROS TOYGLIDE SUPER CONCENTRATED DIMETHICONE GEL TOPICAL 20121001 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL 53389-130_f3118f07-464a-4acc-97f8-b6f1096fd137 53389-130 HUMAN OTC DRUG EROS BODY GLIDE SUPER CONCENTRATED DIMETHICONE GEL TOPICAL 20121203 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL 53389-190_ff676299-7beb-4d2c-bdf9-4f4777546674 53389-190 HUMAN OTC DRUG M WOMANS EROS BODY GLIDE SUPER CONCENTRATED DIMETHICONE GEL TOPICAL 20121203 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL 53389-200_40376df6-5fe9-455b-85c7-793f13ceb494 53389-200 HUMAN OTC DRUG EROS ANAL SILICONE GLIDE DIMETHICONE GEL TOPICAL 20121001 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL 53389-211_efd5e487-3bc5-4108-a5c4-8c68d68619cc 53389-211 HUMAN OTC DRUG EROS CLASSIC SILICONE BODYGLIDE DIMETHICONE GEL TOPICAL 20121001 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL 53389-221_f86953c7-cc08-456d-8e4f-8b59a9a57b67 53389-221 HUMAN OTC DRUG EROS CLASSIC SILICONE BODYGLIDE DIMETHICONE GEL TOPICAL 20121001 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL 53389-231_ffb81ef9-bfe3-4467-a919-45bf76ec65ae 53389-231 HUMAN OTC DRUG EROS LONG STAY SILICONE GLIDE MAN DIMETHICONE GEL TOPICAL 20121001 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL 53389-241_2744e70b-4af2-462c-b35c-0d5806d440f0 53389-241 HUMAN OTC DRUG EROS AQUA BASED GLYCERIN GEL TOPICAL 20121001 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 30 g/100mL 53389-251_ff343cc4-d639-48a7-931d-42bb39c98b63 53389-251 HUMAN OTC DRUG EROS SILICONE GLIDE AND CARE WOMAN DIMETHICONE GEL TOPICAL 20121001 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL 53389-311_b1574122-1288-42a1-a1de-9ee7dece5058 53389-311 HUMAN OTC DRUG EROS AQUA SENSATIONS WATER BASED GLYCERIN GEL TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 5 g/100mL 53389-321_1f83b236-4a5a-4f57-957f-888366a1652e 53389-321 HUMAN OTC DRUG EROS AQUA SENSATIONS AND CARE WOMAN PANTHENOL GEL TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part347 MEGASOL COSMETIC GMBH DEXPANTHENOL .5 g/100mL 53389-331_6c831baf-c867-441e-a65e-7d50eb8c1a61 53389-331 HUMAN OTC DRUG EROS AQUA GLYCERIN GEL TOPICAL 20121001 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 30 g/100mL 53389-410_8a2c4d26-bbca-41be-bde0-af6167a681c0 53389-410 HUMAN OTC DRUG EROS ANAL SILICONE DIMETHICONE GEL TOPICAL 20121001 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL 53389-411_026f7924-2caa-43c9-a08d-06ff2e764346 53389-411 HUMAN OTC DRUG EROS TASTY FRUITS GLYCERIN GEL TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 5 g/100mL 53389-512_524bf741-4cee-42c6-bb4d-e5f3aaf73902 53389-512 HUMAN OTC DRUG EROS FISTING GEL SLIDE X GLYCERIN GEL TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 5 g/100mL 53389-513_a360266f-a49a-4b49-b423-fb305219bbd2 53389-513 HUMAN OTC DRUG EROS FISTING GEL ULTRA X GLYCERIN GEL TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 5 g/100mL 53389-520_70056987-c8a2-44a4-9234-594b5daa40b4 53389-520 HUMAN OTC DRUG PROLONG 101 MAN GLYCERIN SPRAY TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN .5 g/100mL 53389-530_30cac0f7-dcec-4371-9240-3ebaf2460dcc 53389-530 HUMAN OTC DRUG EROS EXPLORER MAN GLYCERIN SPRAY TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 5 g/100mL 53389-540_624faef2-49db-4ff4-9894-07fc8e4aee81 53389-540 HUMAN OTC DRUG EROS RELAX WOMAN GLYCERIN SPRAY TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 5 g/100mL 53389-561_b08329fb-e9c6-4935-bc25-30f8e4da1fde 53389-561 HUMAN OTC DRUG EROS EXTENDED LOVE GLIDE 1 TOP LEVEL GLYCERIN GEL TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 5 g/100mL 53389-562_1a30df36-4736-48be-9246-0ef22e9dabc5 53389-562 HUMAN OTC DRUG EROS EXTENDED LOVE GLIDE 2 TOP LEVEL GLYCERIN GEL TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 5 g/100mL 53389-563_ddb23294-900e-4c8b-b11b-805cec97262b 53389-563 HUMAN OTC DRUG EROS EXTENDED LOVE GLIDE 3 TOP LEVEL GLYCERIN GEL TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 5 g/100mL 53389-570_caf3d022-2a99-47fe-bd26-62b5350e276b 53389-570 HUMAN OTC DRUG EROS EXTENDED LOVE 1 TOP LEVEL GLYCERIN SPRAY TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 5 g/100mL 53389-572_0cf2a8ec-59b7-4186-a722-eaddd2c09a06 53389-572 HUMAN OTC DRUG EROS EXTENDED LOVE 2 TOP LEVEL GLYCERIN SPRAY TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 5 g/100mL 53389-573_646878eb-bf0e-446b-84d4-cc6f9aa09d8e 53389-573 HUMAN OTC DRUG EROS EXTENDED LOVE 3 TOP LEVEL GLYCERIN SPRAY TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 5 g/100mL 53389-600_1d1713c4-b15d-414a-9fb0-f25dd1e513df 53389-600 HUMAN OTC DRUG M EROS LIQUID AQUA BASED GLYCERIN GEL TOPICAL 20121201 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 5 g/100mL 53389-602_fcf0e2ce-7702-43d3-869e-7dd8b4b9e9eb 53389-602 HUMAN OTC DRUG EROS AQUA BASED GLYCERIN GEL TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 5 g/100mL 53389-642_317a8556-e17e-4d7f-96e0-411decdceaac 53389-642 HUMAN OTC DRUG TOY CLEANER ALCOHOL LIQUID TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part333A MEGASOL COSMETIC GMBH ALCOHOL 64.6 g/100mL 53389-661_a73a6a8b-de3d-4545-b23d-1c7e696a66a7 53389-661 HUMAN OTC DRUG ALL PURPOSE CLEANER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part333A MEGASOL COSMETIC GMBH BENZALKONIUM CHLORIDE .1 g/100mL 53401-004_71ae692b-b996-4498-b7f0-15acb582f497 53401-004 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, COATED ORAL 20091010 ANDA ANDA007581 Testpak Holding Company CIPROFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 53401-005_9770c576-1eb6-41ab-ab4d-886121391ca6 53401-005 HUMAN PRESCRIPTION DRUG ciprofloxacin hydrochloride ciprofloxacin hydrochloride TABLET, COATED ORAL 20091203 ANDA ANDA076794 Testpak Holding Company CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 53401-100_660693fd-25d3-485a-86b6-0ef4bda647ce 53401-100 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20110714 ANDA ANDA062505 Aphena Pharma Solutions (Formerly TestPak) DOXYCYCLINE HYCLATE 100 mg/1 53401-200_a7295887-cfd9-4422-9395-01a77676c9f4 53401-200 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100913 ANDA ANDA077289 Aphena Pharma Solutions - New Jersey, LLC CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53401-201_a7295887-cfd9-4422-9395-01a77676c9f4 53401-201 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100913 ANDA ANDA077289 Aphena Pharma Solutions - New Jersey, LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53401-202_a7295887-cfd9-4422-9395-01a77676c9f4 53401-202 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100913 ANDA ANDA077289 Aphena Pharma Solutions - New Jersey, LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53401-300_cc8b4662-82e8-41ef-a112-17c110da6b66 53401-300 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19860710 ANDA ANDA062677 Aphena Pharma Solutions - New Jersey, LLC DOXYCYCLINE HYCLATE 100 mg/1 53401-301_9a9adf9b-389b-40f2-980e-38d7c5b15033 53401-301 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20090801 ANDA ANDA077859 Aphena Pharma Solutions - New Jersey, LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 53405-0001_c4d2c738-e285-4518-9455-e33924dbe76e 53405-0001 HUMAN OTC DRUG E.O.L. Stollingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Niacin Serotonin, 5-Hydroxytryptophan, Betainum Murriatium, Biotin, Cholinum, Coconut Oil, CO Q 10, DL-Methionine, L-Alanine LIQUID ORAL 20131010 UNAPPROVED HOMEOPATHIC Inlight Creation, LLC ALANINE; ALPINE STRAWBERRY; AMINOBENZOIC ACID; BETAINE HYDROCHLORIDE; BIOTIN; BORRELIA BURGDORFERI; BROMELAINS; CHOLECALCIFEROL; CHOLINE HYDROXIDE; COCONUT OIL; COPPER; CRANBERRY; CYSTEINE; CYSTINE; DOPAMINE; GLUTAMIC ACID; GLUTAMINE; HORSE CHESTNUT; ILEX AQUIFOLIUM FRUITING TOP; LEMON JUICE; LITHIUM BROMIDE; LYSINE; MALUS SYLVESTRIS FLOWER; METHIONINE; NIACIN; OXITRIPTAN; PHENYLALANINE; POTASSIUM GLUCONATE; PUMPKIN SEED; RACEMETHIONINE; SELENIUM; SELENIUM DIOXIDE; SERINE; SEROTONIN; SHARK CARTILAGE; SQUALENE; STILLINGIA SYLVATICA ROOT; SUS SCROFA THYMUS; THIAMINE HYDROCHLORIDE; THYROID, PORCINE; UBIDECARENONE; ZINC GLUCONATE 6; 5; 6; 6; 6; 12; 6; 6; 6; 6; 8; 7; 6; 6; 7; 6; 6; 30; 30; 18; 7; 6; 30; 6; 5; 6; 8; 6; 17; 6; 8; 8; 6; 5; 7; 7; 3; 6; 4; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 53405-0002_9afa7c0e-22e2-44cb-88c0-45aa51358f66 53405-0002 HUMAN OTC DRUG E.O.L. Stillingia Sylvatica, Zincum Gluconicum, Fragaria Vesca, Niacin, Serotonin, 5-Hydroxytryptophan, Betainum Muriaticum, Biotin, Cholinum, CO Q 10, DL-Methionine, L-Alanine, L-Cysteine, L-Cystine, L-Glutamic Acid LIQUID ORAL 20131021 UNAPPROVED HOMEOPATHIC InLight Creations, LLC ALANINE; ALPINE STRAWBERRY; AMINOBENZOIC ACID; BETAINE HYDROCHLORIDE; BIOTIN; BORRELIA BURGDORFERI; BROMELAINS; CHOLECALCIFEROL; CHOLINE HYDROXIDE; COCONUT OIL; COPPER; CYSTEINE; CYSTINE; DOPAMINE; GLUTAMIC ACID; GLUTAMINE; HORSE CHESTNUT; ILEX AQUIFOLIUM FRUITING TOP; LEMON JUICE; LITHIUM BROMIDE; LYSINE; MALUS SYLVESTRIS FLOWER; METHIONINE; NIACIN; OXITRIPTAN; PHENYLALANINE; POTASSIUM GLUCONATE; PUMPKIN SEED; RACEMETHIONINE; SELENIUM; SELENIUM DIOXIDE; SERINE; SEROTONIN; SHARK CARTILAGE; SQUALENE; STILLINGIA SYLVATICA ROOT; SUS SCROFA THYMUS; SUS SCROFA THYROID; THIAMINE HYDROCHLORIDE; UBIDECARENONE; ZINC GLUCONATE 6; 5; 6; 6; 6; 12; 6; 6; 6; 12; 8; 6; 6; 7; 6; 6; 30; 30; 18; 7; 6; 30; 6; 5; 6; 8; 6; 17; 6; 8; 8; 6; 5; 7; 7; 3; 6; 6; 4; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 53405-0003_47c8ff0b-b0bb-4be2-91f8-8a85be2cfc52 53405-0003 HUMAN OTC DRUG E.O.L. Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Niacin, Serotonin, 5-Hydroxtryptophan, Betainum Muriaticum, Biotin, Cholinum, Co-Enzyme Q-10, DL-Methionine, L-Alanine, Cysteinum, LIQUID ORAL 20131023 UNAPPROVED HOMEOPATHIC InLight Creation, LLC ALANINE; ALPINE STRAWBERRY; AMINOBENZOIC ACID; BETAINE HYDROCHLORIDE; BIOTIN; BORRELIA BURGDORFERI; BROMELAINS; CHOLECALCIFEROL; CHOLINE HYDROXIDE; COCONUT OIL; COPPER; CRANBERRY; CYSTEINE; CYSTINE; DOPAMINE; GLUTAMIC ACID; GLUTAMINE; HORSE CHESTNUT; ILEX AQUIFOLIUM FLOWERING TOP; LEMON JUICE; LITHIUM BROMIDE; LYSINE; MALUS DOMESTICA FLOWER; METHIONINE; NIACIN; OXITRIPTAN; PHENYLALANINE; POTASSIUM GLUCONATE; PUMPKIN SEED; RACEMETHIONINE; SELENIUM; SELENIUM DIOXIDE; SERINE; SEROTONIN HYDROCHLORIDE; SHARK CARTILAGE; SQUALENE; STILLINGIA SYLVATICA ROOT; SUS SCROFA THYMUS; SUS SCROFA THYROID; THIAMINE HYDROCHLORIDE; UBIDECARENONE; ZINC GLUCONATE 6; 5; 6; 6; 6; 12; 6; 6; 6; 12; 8; 7; 6; 6; 7; 6; 6; 30; 30; 18; 7; 6; 30; 6; 5; 6; 8; 6; 17; 6; 8; 8; 6; 5; 7; 7; 3; 6; 6; 4; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 53405-0004_407c55c6-5ed4-4d2c-83d9-6d6a7a5d6663 53405-0004 HUMAN OTC DRUG E.O.L. Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vescus, Niacin, Serotonin (Hydrochloride), 5-Hydroxytryptophan, Betainum Muriaticum LIQUID ORAL 20140707 UNAPPROVED HOMEOPATHIC InLight Creation, LLC. AESCULUS HIPPOCASTANUM FLOWER; ALANINE; ALPINE STRAWBERRY; AMINOBENZOIC ACID; BETAINE HYDROCHLORIDE; BIOTIN; BORRELIA BURGDORFERI; BROMELAINS; CANDIDA ALBICANS; CHOLECALCIFEROL; CHOLINE HYDROXIDE; COCONUT OIL; COPPER; CRANBERRY; CYSTEINE; CYSTINE; DOPAMINE HYDROCHLORIDE; GLUTAMIC ACID; GLUTAMINE; ILEX AQUIFOLIUM FLOWERING TOP; LEMON JUICE; LITHIUM BROMIDE; LYSINE; MALUS DOMESTICA FLOWER; METHIONINE; NIACIN; OXITRIPTAN; PHENYLALANINE; POTASSIUM GLUCONATE; PUMPKIN SEED; RACEMETHIONINE; SELENIUM; SELENIUM DIOXIDE; SERINE; SEROTONIN HYDROCHLORIDE; SHARK CARTILAGE; SQUALENE; STILLINGIA SYLVATICA ROOT; SUS SCROFA THYMUS; THIAMINE HYDROCHLORIDE; THYROID, PORCINE; UBIDECARENONE; ZINC GLUCONATE 30; 6; 5; 6; 6; 6; 12; 6; 12; 6; 6; 12; 8; 7; 6; 6; 7; 6; 6; 30; 18; 7; 6; 30; 6; 5; 6; 8; 6; 17; 6; 8; 8; 6; 5; 7; 7; 3; 6; 4; 6; 6; 3 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 53407-104_832dd2f9-b7a0-448d-ae64-74dc01d5fe3e 53407-104 HUMAN OTC DRUG Algenist Avobenzone, Homosalate, Octisalate CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Solazyme, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE 30; 80; 50 mg/mL; mg/mL; mg/mL 53407-138_a060dff3-d195-41fc-8b67-8bd9a162fbc7 53407-138 HUMAN OTC DRUG Algenist Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Solazyme, Inc. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 75; 20; 171 mg/mL; mg/mL; mg/mL 53407-155_ce6c13f4-9b9f-415f-9a3f-0b8b8cad7c50 53407-155 HUMAN OTC DRUG Algenist Avobenzone, Homosalate, Octisalate CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Solazyme, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE 30; 80; 50 mg/mL; mg/mL; mg/mL 53425-001_923c1c3a-ed86-4651-956a-f7a4cacf4dd7 53425-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100719 UNAPPROVED MEDICAL GAS IWS Gas and Supply of Texas, LTD OXYGEN 995 mL/L 53425-002_efeaf888-18b5-4e82-b08c-551dfb0a40bf 53425-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20111101 UNAPPROVED MEDICAL GAS IWS Gas and Supply of Texas, LTD NITROGEN 995 mL/L 53439-100_cda8f72f-d34c-4a2d-8762-24ff2717311b 53439-100 HUMAN OTC DRUG Cut Care Alcohol Prep Pad Isopropyl alcohol SWAB TOPICAL 20130915 OTC MONOGRAPH NOT FINAL part333A Zeus Medical Holdings LLC ISOPROPYL ALCOHOL .7 mL/1 53439-120_cc58d0da-6bde-49eb-b3df-fd6a542939dd 53439-120 HUMAN OTC DRUG Cut Care Insect Bite Antiseptic and Pain Relieving Wipe Benzocaine and Isopropyl Alcohol SWAB TOPICAL 20130915 OTC MONOGRAPH NOT FINAL part348 Zeus Medical Holdings LLC BENZOCAINE; ISOPROPYL ALCOHOL .021; .7 g/1; mL/1 53439-130_f1633a33-a170-441d-a74f-304b0993807d 53439-130 HUMAN OTC DRUG Cut Care Benzalkonium Chloride Antiseptic Benzalkonium Chloride SWAB TOPICAL 20130915 OTC MONOGRAPH NOT FINAL part333A Zeus Medical Holdings LLC BENZALKONIUM CHLORIDE 1.3 mg/1 53440-001_ef165a3a-c75e-4d81-b347-b173e1d03ce0 53440-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000101 UNAPPROVED MEDICAL GAS WestAir Gases & Equipment, Inc. OXYGEN 995 mL/L 53440-002_6e3fd42b-2988-4190-99f4-ffa773bdbff0 53440-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20000101 UNAPPROVED MEDICAL GAS WestAir Gases & Equipment, Inc. NITROGEN 995 mL/L 53440-003_11551204-cb3a-4965-8331-a8c7a25caf3d 53440-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20000101 UNAPPROVED MEDICAL GAS WestAir Gases & Equipment, Inc. NITROUS OXIDE 995 mL/L 53440-004_bf51772d-8822-443b-bac4-d51be88b8cfe 53440-004 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20000101 UNAPPROVED MEDICAL GAS WestAir Gases & Equipment, Inc CARBON DIOXIDE 995 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 53440-005_e999faac-e682-4b59-80ec-71e7d108af19 53440-005 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20000101 UNAPPROVED MEDICAL GAS WestAir Gases & Equipment, Inc. AIR 995 mL/L 53440-006_5b061e38-3d49-44fd-bc6f-504a607e9dc4 53440-006 HUMAN PRESCRIPTION DRUG Carbogen Carbogen GAS RESPIRATORY (INHALATION) 20000101 UNAPPROVED MEDICAL GAS WestAir Gases and Equipment, Inc. CARBON DIOXIDE; OXYGEN 5; 95 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 53441-251_1111ed8b-ec9b-4066-bfc6-78c6691efd57 53441-251 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 20140530 OTC MONOGRAPH FINAL part340 National Distribution Network (Smart Choice) CAFFEINE 200 mg/1 53441-268_a00f3ca8-6669-49e1-a6ea-aee27ae5e9cc 53441-268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part356 National Distribution Network (Smart Choice) HYDROGEN PEROXIDE 2.65 mL/100mL 53441-275_78752d5d-7d32-4d7e-8122-f9f8b30519e6 53441-275 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A National Distribution Network (Smart Choice) ISOPROPYL ALCOHOL 70 mL/100mL 53441-311_827f02b7-579b-4a31-8f52-7d3bcfa841d7 53441-311 HUMAN OTC DRUG Day Time Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 National Distribution Network (Smart Choice) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 53441-342_73b9da56-3eaf-4d6f-bc49-f033e478e72c 53441-342 HUMAN OTC DRUG Nighttime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 National Distribution Network (Smart Choice) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 53441-343_d260d192-0d7f-4aa7-b13e-651440fb642d 53441-343 HUMAN OTC DRUG Nighttime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 National Distribution Network (Smart Choice) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 53441-344_7fc11bdd-086a-425b-b716-2e83771abb3e 53441-344 HUMAN OTC DRUG Night Time Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 National Distribution Network (Smart Choice) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 53441-346_ab737a63-ac92-498b-87ed-56f9523316d1 53441-346 HUMAN OTC DRUG Nighttime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 National Distribution Network (Smart Choice) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 53441-630_92d1b930-dcb5-4c54-9ed9-d59642c9f3ca 53441-630 HUMAN OTC DRUG Motion Sickness Original Formula Dimenhydrinate TABLET ORAL 20140630 OTC MONOGRAPH FINAL part336 National Distribution Network (Smart Choice) DIMENHYDRINATE 50 mg/1 53441-670_e66ebfea-c2cd-46d9-b6e5-ab9b48a01581 53441-670 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine Hydrochloride TABLET ORAL 20140630 OTC MONOGRAPH FINAL part341 National Distribution Network (Smart Choice) PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 53443-901_ac8d1082-cdfa-47c9-b550-2a04dd1dbfda 53443-901 HUMAN OTC DRUG Jhirmack Distinctions Silver Plus Dandruff Pyrithione Zinc LIQUID TOPICAL 20121022 OTC MONOGRAPH FINAL part358H Inspired Beauty Brands PYRITHIONE ZINC 1 g/100mL 53448-0001_92355b64-e36c-40c5-9aa2-788bfda72ba5 53448-0001 HUMAN OTC DRUG Psoriasis Skin Cream Berberis Aquifolium, Calendula Officinalis, Hydrocotyle Asiatica, Thuja Occidentalis, Borax, Natrum Muriaticum CREAM TOPICAL 20130425 UNAPPROVED HOMEOPATHIC Natural Products Ctr AZADIRACHTA INDICA BARK; CALENDULA OFFICINALIS FLOWERING TOP; CENTELLA ASIATICA; MAHONIA AQUIFOLIUM ROOT BARK; SODIUM BORATE; SODIUM CHLORIDE; TETRAARSENIC TETRASULFIDE; THUJA OCCIDENTALIS LEAF; TURMERIC 3; 3; 3; 1; 8; 8; 12; 3; 12 [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 53451-0101_7e3bbf56-4cf9-11e4-916c-0800200c9a66 53451-0101 HUMAN PRESCRIPTION DRUG Horizant gabapentin enacarbil TABLET, EXTENDED RELEASE ORAL 20130501 NDA NDA022399 XenoPort Inc. GABAPENTIN ENACARBIL 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 53451-0103_7e3bbf56-4cf9-11e4-916c-0800200c9a66 53451-0103 HUMAN PRESCRIPTION DRUG Horizant gabapentin enacarbil TABLET, EXTENDED RELEASE ORAL 20130501 NDA NDA022399 XenoPort Inc. GABAPENTIN ENACARBIL 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 53462-003_3c754532-d9a5-f876-00c4-05a4c9b21efa 53462-003 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate 0.12% Oral Rinse CHLORHEXIDINE GLUCONATE LIQUID BUCCAL 20140120 ANDA ANDA077789 Sage Products LLC CHLORHEXIDINE GLUCONATE 1.2 [iU]/mL Decreased Cell Wall Integrity [PE] 53462-007_0f07c40c-0c16-48da-a265-fdda3ceb2736 53462-007 HUMAN OTC DRUG Skin antisepsis, oral cleansing, nasal antisepsis CHLORHEXIDINE GLUCONATE KIT 20120206 NDA NDA021669 Sage Products, Inc. 53462-008_d36bf0aa-9dec-3328-cab8-8fc6748dafb3 53462-008 HUMAN OTC DRUG Skin antisepsis, oral cleansing, nasal antisepsis CHLORHEXIDINE GLUCONATE KIT 20120206 NDA NDA021669 Sage Products, Inc. 53462-075_4ac4fa28-bbd2-4f62-9716-f2c627c62889 53462-075 HUMAN OTC DRUG hydrogen peroxide hydrogen peroxide MOUTHWASH BUCCAL 19980521 OTC MONOGRAPH NOT FINAL part356 Sage Products, Inc. HYDROGEN PEROXIDE 15 mg/mL 53462-120_816c614e-b914-ce70-3823-e8469e45dbd7 53462-120 HUMAN OTC DRUG Toothette Oral Care Single Use System with Antiseptic Oral Rinse HYDROGEN PEROXIDE KIT 20130331 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC 53462-175_23111726-c7a0-4251-be59-c733427aab93 53462-175 HUMAN OTC DRUG cetylpyridinium chloride cetylpyridinium chloride MOUTHWASH BUCCAL 20011228 OTC MONOGRAPH NOT FINAL part356 Sage Products Inc. CETYLPYRIDINIUM CHLORIDE .5 mg/mL 53462-275_fc1a5bf1-71b7-4c8f-a59f-fdb1823bf50f 53462-275 HUMAN OTC DRUG cetylpyridinium chloride cetylpyridinium chloride MOUTHWASH BUCCAL 20090109 OTC MONOGRAPH NOT FINAL part356 Sage Products Inc. CETYLPYRIDINIUM CHLORIDE .5 mg/mL 53462-306_24000dad-f2d5-5b11-0958-c12e044e71ea 53462-306 HUMAN OTC DRUG QCare CETYLPYRIDINIUM CHLORIDE KIT 20011228 OTC MONOGRAPH NOT FINAL part356 Sage Products, Inc. 53462-308_24000dad-f2d5-5b11-0958-c12e044e71ea 53462-308 HUMAN OTC DRUG QCare CETYLPYRIDINIUM CHLORIDE KIT 20011228 OTC MONOGRAPH NOT FINAL part356 Sage Products, Inc. 53462-426_567bf599-4958-91c7-5c01-9c38a0d2da52 53462-426 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System, Q4 CETYLPYRIDINIUM CHLORIDE and HYDROGEN PEROXIDE KIT 19980521 OTC MONOGRAPH NOT FINAL part356 Sage Products, LLC 53462-502_5fb933b5-c1df-269c-a03c-d42ea76918b0 53462-502 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System, Q2 CETYLPYRIDINIUM CHLORIDE and HYDROGEN PEROXIDE KIT 19980521 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC 53462-504_207b8fdf-4f03-69b8-4621-b8054b7ae6a6 53462-504 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System, Q4 CETYLPYRIDINIUM CHLORIDE and HYDROGEN PEROXIDE KIT 19980521 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC 53462-592_3b467496-dde7-6c24-418f-68843a8acce5 53462-592 HUMAN OTC DRUG Oral Cleansing and Suctioning System, q2 CHLORHEXIDINE GLUCONATE and HYDROGEN PEROXIDE KIT 20140701 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC 53462-594_12d254ce-831a-54cd-221b-33c205f99696 53462-594 HUMAN OTC DRUG Oral Cleansing and Suctioning System, q4 CHLORHEXIDINE GLUCONATE and HYDROGEN PEROXIDE KIT 20140701 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC 53462-705_a5858354-e109-26dc-728a-485c2dc765f0 53462-705 HUMAN OTC DRUG CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE CLOTH TOPICAL 20060201 NDA NDA021669 Sage Products LLC CHLORHEXIDINE GLUCONATE 500 mg/1 53462-714_b08bc4f9-85db-b57c-5e1d-97e3383acf18 53462-714 HUMAN OTC DRUG QCare Petite Size Oral Cleansing and Suctioning System CETYLPYRIDINIUM CHLORIDE KIT 20130402 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC 53462-904_21eb36ec-b44c-93e7-3547-2d68ce31b44b 53462-904 HUMAN OTC DRUG QCare Rx Oral Cleansing and Suctioning System, Q4 CHLORHEXIDINE GLUCONATE and HYDROGEN PEROXIDE KIT 20071231 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC 53462-915_eb4bee47-956a-4f00-9b89-5f5397fc71d5 53462-915 HUMAN OTC DRUG dimethicone dimethicone CLOTH TOPICAL 19900101 OTC MONOGRAPH NOT FINAL part356 Sage Products Inc. DIMETHICONE 756 mg/1 53462-922_e8d23d6a-3828-8c4c-1561-287bab6cb834 53462-922 HUMAN OTC DRUG QCare Rx Oral Cleansing and Suctioning System, Q2 CHLORHEXIDINE GLUCONATE and HYDROGEN PEROXIDE KIT 20071231 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC 53462-924_21843493-2870-a8ca-7be1-424237830f98 53462-924 HUMAN OTC DRUG QCare Rx Oral Cleansing and Suctioning System, Q4 CHLORHEXIDINE GLUCONATE and HYDROGEN PEROXIDE KIT 20071231 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC 53462-926_f769c6ad-189e-4490-b44d-b12dd3f5dffe 53462-926 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System, Q2 HYDROGEN PEROXIDE KIT 19980521 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC 53462-927_e7fe1a3d-07d3-4ed1-9a1e-9130a7fdf505 53462-927 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System, Q4 HYDROGEN PEROXIDE KIT 19980521 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC 53462-932_e7e9802d-c8b2-f0cb-6a81-56019e13dbf7 53462-932 HUMAN OTC DRUG QCare Rx Oral Cleansing and Suctioning System CHLORHEXIDINE GLUCONATE and HYDROGEN PEROXIDE KIT 20071231 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC 53489-110_cdfbe64d-ba89-4cb7-bc1a-3bfaadd0258c 53489-110 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19911017 ANDA ANDA089346 Mutual Pharmaceutical Company, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 53489-118_c67551bf-896d-4755-ab73-ad25a724da3a 53489-118 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19860710 ANDA ANDA062676 Mutual Pharmaceutical Company, Inc. DOXYCYCLINE HYCLATE 50 mg/1 53489-119_c67551bf-896d-4755-ab73-ad25a724da3a 53489-119 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19860710 ANDA ANDA062676 Mutual Pharmaceutical Company, Inc. DOXYCYCLINE HYCLATE 100 mg/1 53489-120_c67551bf-896d-4755-ab73-ad25a724da3a 53489-120 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19860710 ANDA ANDA062677 Mutual Pharmaceutical Company, Inc. DOXYCYCLINE HYCLATE 100 mg/1 53489-141_0c2440a6-89fe-4333-aa30-773d8643ad02 53489-141 HUMAN PRESCRIPTION DRUG Quinidine Gluconate Quinidine Gluconate TABLET, EXTENDED RELEASE ORAL 19870210 ANDA ANDA089338 Mutual Pharmaceutical QUINIDINE GLUCONATE 324 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] 53489-143_8103992e-cfa8-4118-915c-76674b6e1809 53489-143 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET ORAL 19860723 ANDA ANDA089424 Mutual Pharmaceutical Company, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 53489-144_10dac2be-519b-4541-9db0-c7f5a1a9eeb4 53489-144 HUMAN PRESCRIPTION DRUG Spironolactone and Hydrochlorothiazide Spironolactone and Hydrochlorothiazide TABLET ORAL 19870702 ANDA ANDA089534 Mutual Pharmaceutical Company, Inc. HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 25; 25 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 53489-145_b1637a8d-bc38-4a9f-a9f2-38af10a4df98 53489-145 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 19860825 ANDA ANDA071017 Mutual Pharmaceutical Company, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 53489-146_b1637a8d-bc38-4a9f-a9f2-38af10a4df98 53489-146 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 19860825 ANDA ANDA071017 Mutual Pharmaceutical Company, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 53489-148_8cbc5493-01e0-4c33-9e03-bdfb179adb7e 53489-148 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride Thioridazine Hydrochloride TABLET, FILM COATED ORAL 19881007 ANDA ANDA089953 Mutual Pharmaceutical THIORIDAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53489-149_8cbc5493-01e0-4c33-9e03-bdfb179adb7e 53489-149 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride Thioridazine Hydrochloride TABLET, FILM COATED ORAL 19881007 ANDA ANDA089953 Mutual Pharmaceutical THIORIDAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53489-150_8cbc5493-01e0-4c33-9e03-bdfb179adb7e 53489-150 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride Thioridazine Hydrochloride TABLET, FILM COATED ORAL 19881007 ANDA ANDA089953 Mutual Pharmaceutical THIORIDAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53489-156_04941bc0-3ef8-42fd-ac94-58019026e9db 53489-156 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 19870109 ANDA ANDA071450 Mutual Pharmaceutical ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 53489-157_04941bc0-3ef8-42fd-ac94-58019026e9db 53489-157 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 19870109 ANDA ANDA071450 Mutual Pharmaceutical ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 53489-159_57ee1a9a-25d6-41ea-b86c-b9cc5a8cebe6 53489-159 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE Acetaminophen and Codeine Phosphate TABLET ORAL 19880210 ANDA ANDA089671 Mutual Pharmaceutical Company, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 53489-160_57ee1a9a-25d6-41ea-b86c-b9cc5a8cebe6 53489-160 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE Acetaminophen and Codeine Phosphate TABLET ORAL 19880210 ANDA ANDA089672 Mutual Pharmaceutical Company, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 53489-161_57ee1a9a-25d6-41ea-b86c-b9cc5a8cebe6 53489-161 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE Acetaminophen and Codeine Phosphate TABLET ORAL 19880210 ANDA ANDA089673 Mutual Pharmaceutical Company, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 53489-176_6add3dd0-7f72-4fb5-82d1-951c0658cc0c 53489-176 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 19891205 ANDA ANDA072637 Mutual Pharmaceutical Company, Inc. ALBUTEROL SULFATE 2 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 53489-177_6add3dd0-7f72-4fb5-82d1-951c0658cc0c 53489-177 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 19891205 ANDA ANDA072637 Mutual Pharmaceutical Company, Inc. ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 53489-215_c0fc5006-ac11-423d-b189-7e95f5fe8d99 53489-215 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 Mutual Pharmaceutical Company, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 53489-216_c0fc5006-ac11-423d-b189-7e95f5fe8d99 53489-216 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070924 Mutual Pharmaceutical Company, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 53489-217_c0fc5006-ac11-423d-b189-7e95f5fe8d99 53489-217 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070923 Mutual Pharmaceutical Company, Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 53489-281_f840caed-fed3-4948-b3ab-0c9646446eff 53489-281 HUMAN PRESCRIPTION DRUG Ergoloid Mesylates Dihydroergocornine Mesylate, Dihydroergocristine Mesylate, Dihydro-.alpha.-ergocryptine mesylate, and Dihydro-.beta.-ergocryptine mesylate TABLET ORAL 19911031 ANDA ANDA081113 Mutual Pharmaceutical Company, Inc. DIHYDRO-.ALPHA.-ERGOCRYPTINE MESYLATE; DIHYDRO-.BETA.-ERGOCRYPTINE MESYLATE; DIHYDROERGOCORNINE MESYLATE; DIHYDROERGOCRISTINE MESYLATE .222; .111; .333; .333 mg/1; mg/1; mg/1; mg/1 53489-328_8103992e-cfa8-4118-915c-76674b6e1809 53489-328 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19860723 ANDA ANDA089424 Mutual Pharmaceutical Company, Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 53489-329_8103992e-cfa8-4118-915c-76674b6e1809 53489-329 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19860723 ANDA ANDA089424 Mutual Pharmaceutical Company, Inc. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 53489-330_812dc7ce-24dd-4ecc-99bf-82098620fba6 53489-330 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19900605 ANDA ANDA081048 Mutual Pharmaceutical Company, Inc. IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 53489-331_812dc7ce-24dd-4ecc-99bf-82098620fba6 53489-331 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19900605 ANDA ANDA081049 Mutual Pharmaceutical Company, Inc. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 53489-332_812dc7ce-24dd-4ecc-99bf-82098620fba6 53489-332 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19900605 ANDA ANDA081050 Mutual Pharmaceutical Company, Inc. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 53489-368_fe0acfa1-c829-4633-929c-2b7048358728 53489-368 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 ANDA ANDA075896 Mutual Pharmaceutical Company, Inc. FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53489-369_fe0acfa1-c829-4633-929c-2b7048358728 53489-369 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 ANDA ANDA075896 Mutual Pharmaceutical Company, Inc. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53489-370_fe0acfa1-c829-4633-929c-2b7048358728 53489-370 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 ANDA ANDA075896 Mutual Pharmaceutical Company, Inc. FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53489-376_aeafc45f-6637-4818-90b1-7ddc9dca9889 53489-376 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE ORAL 20030828 ANDA ANDA076570 Mutual Pharmaceutical Company, Inc. TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 53489-386_870b4c4d-a26b-4319-b91d-cb8322ca3b98 53489-386 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 19951214 ANDA ANDA072709 Mutual Pharmaceutical Company, Inc. MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 53489-387_870b4c4d-a26b-4319-b91d-cb8322ca3b98 53489-387 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 19951214 ANDA ANDA072709 Mutual Pharmaceutical Company, Inc. MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 53489-400_5424dda5-d675-404a-964c-1a781afe601b 53489-400 HUMAN PRESCRIPTION DRUG Nystatin nystatin TABLET, FILM COATED ORAL 19881222 ANDA ANDA062838 Mutual Pharmaceutical Company, Inc. NYSTATIN 500000 [USP'U]/1 Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 53489-406_a78158e1-7c6b-4104-912e-f0650abe3fa9 53489-406 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040526 Mutual Pharmaceutical Company, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 53489-433_bb84046d-9d7a-4b50-8bc4-fa1143060518 53489-433 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20031023 ANDA ANDA040525 Mutual Pharmaceutical Company, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 53489-478_82a2c553-3721-4666-9030-5ef950307bad 53489-478 HUMAN PRESCRIPTION DRUG SULINDAC sulindac TABLET ORAL 20090904 ANDA ANDA072050 Mutual Pharmaceutical Company, Inc. SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53489-479_82a2c553-3721-4666-9030-5ef950307bad 53489-479 HUMAN PRESCRIPTION DRUG SULINDAC sulindac TABLET ORAL 20090904 ANDA ANDA072051 Mutual Pharmaceutical Company, Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53489-500_8cbc5493-01e0-4c33-9e03-bdfb179adb7e 53489-500 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride Thioridazine Hydrochloride TABLET, FILM COATED ORAL 19881007 ANDA ANDA089953 Mutual Pharmaceutical THIORIDAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53489-506_cd0fe55c-2995-4c8a-9f9b-531c09c89f92 53489-506 HUMAN PRESCRIPTION DRUG TOLMETIN SODIUM tolmetin sodium TABLET ORAL 20090904 ANDA ANDA073311 Mutual Pharmaceutical Company, Inc. TOLMETIN SODIUM 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53489-507_cd0fe55c-2995-4c8a-9f9b-531c09c89f92 53489-507 HUMAN PRESCRIPTION DRUG TOLMETIN SODIUM tolmetin sodium CAPSULE ORAL 20090904 ANDA ANDA073311 Mutual Pharmaceutical Company, Inc. TOLMETIN SODIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53489-510_91c859db-bb05-4702-a59a-3c659c074e6b 53489-510 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 19930324 ANDA ANDA073137 Mutual Pharmaceutical Company, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 53489-511_91c859db-bb05-4702-a59a-3c659c074e6b 53489-511 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 19930324 ANDA ANDA073137 Mutual Pharmaceutical Company, Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 53489-517_91c859db-bb05-4702-a59a-3c659c074e6b 53489-517 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 19930324 ANDA ANDA073137 Mutual Pharmaceutical Company, Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 53489-529_0f924587-1e05-4755-80cd-7ce58ba0300f 53489-529 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19930330 ANDA ANDA073475 Mutual Pharmaceutical Company, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53489-530_0f924587-1e05-4755-80cd-7ce58ba0300f 53489-530 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19930330 ANDA ANDA073476 Mutual Pharmaceutical Company, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53489-531_86da35ec-fbfa-4474-bf4b-a58d9c737a19 53489-531 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19930429 ANDA ANDA073582 Mutual Pharmaceutical Company, Inc. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 53489-532_86da35ec-fbfa-4474-bf4b-a58d9c737a19 53489-532 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19930429 ANDA ANDA073582 Mutual Pharmaceutical Company, Inc. ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 53489-536_0f924587-1e05-4755-80cd-7ce58ba0300f 53489-536 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19970730 ANDA ANDA074499 Mutual Pharmaceutical Company, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53489-551_860c5c4e-8f24-4537-9bd1-f2efa189adc0 53489-551 HUMAN PRESCRIPTION DRUG PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET, FILM COATED ORAL 20011129 ANDA ANDA075998 Mutual Pharmaceutical Co., Inc. PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] 53489-552_860c5c4e-8f24-4537-9bd1-f2efa189adc0 53489-552 HUMAN PRESCRIPTION DRUG PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET, FILM COATED ORAL 20011129 ANDA ANDA075998 Mutual Pharmaceutical Co., Inc. PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] 53489-553_860c5c4e-8f24-4537-9bd1-f2efa189adc0 53489-553 HUMAN PRESCRIPTION DRUG PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET, FILM COATED ORAL 20011129 ANDA ANDA075998 Mutual Pharmaceutical Co., Inc. PROPAFENONE HYDROCHLORIDE 300 mg/1 Antiarrhythmic [EPC] 53489-590_f31e2835-b272-4f87-bbc7-6cb4ec25fde9 53489-590 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19950523 ANDA ANDA073541 Mutual Pharmaceutical CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 53489-591_f31e2835-b272-4f87-bbc7-6cb4ec25fde9 53489-591 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19950523 ANDA ANDA073541 Mutual Pharmaceutical CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 53489-607_36f83432-6257-4cda-9902-510ec4b0975c 53489-607 HUMAN PRESCRIPTION DRUG lovastatin lovastatin TABLET ORAL 20060414 ANDA ANDA077520 Mutual Pharmaceutical Company, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53489-608_36f83432-6257-4cda-9902-510ec4b0975c 53489-608 HUMAN PRESCRIPTION DRUG lovastatin lovastatin TABLET ORAL 20060414 ANDA ANDA077520 Mutual Pharmaceutical Company, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53489-609_36f83432-6257-4cda-9902-510ec4b0975c 53489-609 HUMAN PRESCRIPTION DRUG lovastatin lovastatin TABLET ORAL 20060414 ANDA ANDA077520 Mutual Pharmaceutical Company, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53489-647_6d10fb92-0944-44c5-beb3-36461a3da929 53489-647 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20050513 ANDA ANDA065134 Mutual Pharmaceutical Company, Inc. DOXYCYCLINE HYCLATE 20 mg/1 53489-648_b3ee2550-e764-4dbb-9bac-fcd83649327e 53489-648 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20090909 ANDA ANDA078581 Mutual Pharmaceutical Company, Inc. TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 53489-649_b3ee2550-e764-4dbb-9bac-fcd83649327e 53489-649 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20061026 ANDA ANDA071175 Mutual Pharmaceutical Company, Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 53489-650_b3ee2550-e764-4dbb-9bac-fcd83649327e 53489-650 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20061026 ANDA ANDA071175 Mutual Pharmaceutical Company, Inc. TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 53489-651_b3ee2550-e764-4dbb-9bac-fcd83649327e 53489-651 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20061026 ANDA ANDA071175 Mutual Pharmaceutical Company, Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 53489-676_4bbc8de2-372b-4eee-99e0-f9ce036e850e 53489-676 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20130812 ANDA ANDA040526 Mutual Pharmaceutical Company, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 53489-677_86565773-6a1d-4a71-8291-dface908566f 53489-677 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid TABLET ORAL 20090831 NDA AUTHORIZED GENERIC NDA022418 Mutual Pharmaceutical Company, Inc. FENOFIBRIC ACID 35 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 53489-678_86565773-6a1d-4a71-8291-dface908566f 53489-678 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid TABLET ORAL 20090831 NDA AUTHORIZED GENERIC NDA022418 Mutual Pharmaceutical Company, Inc. FENOFIBRIC ACID 105 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 53489-700_e9ab5526-2fb2-4b82-9de1-00ec6a8d7c80 53489-700 HUMAN PRESCRIPTION DRUG Quinine Sulfate Quinine Sulfate CAPSULE ORAL 20120723 NDA AUTHORIZED GENERIC NDA021799 Mutual Pharmaceutical Company, Inc. QUININE SULFATE 324 mg/1 Antimalarial [EPC] 53499-0094_a7ef3c63-ddb7-4e6a-b268-7e48b11ccf7b 53499-0094 HUMAN OTC DRUG Alfalco Alfalfa, Cinchona officinalis, Formicum acidum, Hydrastis canadensis, Kali phosphoricum, Natrum phosphoricum, Calcarea phosphorica, Ferrum phosphoricum, Magnesia phosphorica LIQUID ORAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ALFALFA; CINCHONA OFFICINALIS BARK; FERRUM PHOSPHORICUM; FORMIC ACID; GOLDENSEAL; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, DIBASIC ANHYDROUS; TRICALCIUM PHOSPHATE 1; 2; 8; 3; 2; 8; 6; 6; 8 [hp_X]/224g; [hp_X]/224g; [hp_X]/224g; [hp_X]/224g; [hp_X]/224g; [hp_X]/224g; [hp_X]/224g; [hp_X]/224g; [hp_X]/224g 53499-0098_ade0ce58-350e-4eb8-bdee-9d0a3754a4f3 53499-0098 HUMAN OTC DRUG CHILDRENS ALPHA CF ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT,IPECAC, PHOSPHORUS TABLET SUBLINGUAL 20040701 UNAPPROVED HOMEOPATHIC Nature's Way Holding Co ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS 7; 7; 7; 7; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 53499-0133_b20451e9-bf38-4f95-a318-6ebf8dccbb9a 53499-0133 HUMAN OTC DRUG Coffea cruda Coffea cruda TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. ARABICA COFFEE BEAN 6 [hp_X]/1 53499-0163_3bc10619-77e6-4aef-b36d-9c916d8d2c46 53499-0163 HUMAN OTC DRUG Umcka ColdCare Orange Pelargonium sidoides LOZENGE ORAL 20090701 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/1 53499-0165_379f43a4-4406-457a-9df2-4c67572549f9 53499-0165 HUMAN OTC DRUG Umcka ColdCare Childrens Cherry Pelargonium sidoides SYRUP ORAL 20090901 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/120mL 53499-0166_91bb51ed-ca94-4a93-b598-7fa933b39478 53499-0166 HUMAN OTC DRUG Umcka Cherry Childrens FastActives Pelargonium sidoides POWDER ORAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/467mg 53499-0171_df941ac6-1062-4d45-b840-9a67565b7219 53499-0171 HUMAN OTC DRUG Coffea cruda Coffea cruda TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. ARABICA COFFEE BEAN 30 [hp_C]/1 53499-0172_de591458-eca1-4cf6-a778-24bea780465a 53499-0172 HUMAN OTC DRUG Coffea cruda Coffea cruda TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. ARABICA COFFEE BEAN 30 [hp_X]/1 53499-0190_a069fe86-3efc-438d-84b2-99aab4625f67 53499-0190 HUMAN OTC DRUG Alpha CF ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUSEUCALYPTUS GLOBULUS LEAF LIQUID SUBLINGUAL 20040701 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS 4; 4; 2; 2; 4; 3; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL 53499-0293_4d0a0f3c-9568-463b-8661-ce3a1951424a 53499-0293 HUMAN OTC DRUG Cough and Bronchial ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN SYRUP ORAL 20040701 UNAPPROVED HOMEOPATHIC Nature's Way Products, LLC ACONITUM NAPELLUS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN 3; 3; 6; 3; 6 [hp_X]/118mL; [hp_X]/118mL; [hp_C]/118mL; [hp_X]/118mL; [hp_C]/118mL 53499-0339_367bf9fb-4edf-479f-a469-7c6e1ef7c151 53499-0339 HUMAN OTC DRUG ALPHA CF ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT,IPECAC , PHOSPHORUS TABLET SUBLINGUAL 20110818 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS 4; 4; 2; 2; 4; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 53499-0390_8905a5ab-0219-4405-9ed9-ecdb073a10b4 53499-0390 HUMAN OTC DRUG Florasone CARDIOSPERMUM HALICACABUM FLOWERING TOP CREAM TOPICAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. CARDIOSPERMUM HALICACABUM FLOWERING TOP 1 [hp_X]/28g 53499-0393_1ab21218-ba51-4c3b-94b2-371c57df7669 53499-0393 HUMAN OTC DRUG Childrens Cough and Bronchial ANTIMONY PENTASULFIDE, BRYONIA ALBA ROOT, DROSERA ROTUNDIFOLIA, EUCALYPTUS GLOBULUS LEAF, IPECAC, STAR ANISE SYRUP ORAL 20040701 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ANTIMONY PENTASULFIDE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; EUCALYPTUS GLOBULUS LEAF; IPECAC; STAR ANISE 6; 3; 3; 3; 4; 1 [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL 53499-0490_ec2cf134-831b-4b72-adbd-6b07beb2a43c 53499-0490 HUMAN OTC DRUG ALPHA CF ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT,IPECAC TABLET SUBLINGUAL 20040701 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS 4; 4; 2; 2; 4; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 53499-0533_6ae355c3-5dd1-449d-ab69-a3c63aa89a12 53499-0533 HUMAN OTC DRUG UMCKA THROAT PELARGONIUM SIDOIDES ROOT SPRAY ORAL 20140901 UNAPPROVED HOMEOPATHIC Natures Way Holding Co PELARGONIUM SIDOIDES ROOT 1 [hp_X]/59mL 53499-0598_128350c2-55f8-4cf1-aaee-7d9ae2e80481 53499-0598 HUMAN OTC DRUG SMOKE FREE DIEFFENBACHIA SEGUINE, DAPHNE ODORA BARK, GRAPHITES, VALERIAN TABLET SUBLINGUAL 20110818 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. DAPHNE ODORA BARK; DIEFFENBACHIA SEGUINE; GRAPHITE; VALERIAN 6; 6; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 53499-0693_01c05dc2-a9a7-42ce-b626-2d5e64d37b80 53499-0693 HUMAN OTC DRUG Nightime Cough and Bronchial ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN SYRUP ORAL 20040701 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ACONITUM NAPELLUS; ARABICA COFFEE BEAN; BRYONIA ALBA ROOT; CALCIUM SULFIDE; MEDICAGO SATIVA LEAF; OAT; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN 3; 6; 3; 6; 1; 1; 3; 6 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_C]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_C]/118mL 53499-0990_85f3ceea-3f47-4b07-a898-3983eec9687e 53499-0990 HUMAN OTC DRUG PSORIAFLORA MAHONIA AQUIFOLIUM ROOT BARK CREAM TOPICAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. MAHONIA AQUIFOLIUM ROOT BARK 1 [hp_X]/28g 53499-0991_b6541895-da80-47ee-ac69-4e69843d6864 53499-0991 HUMAN OTC DRUG TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF LIQUID ORAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. TOXICODENDRON PUBESCENS LEAF 3 [hp_X]/30mL 53499-1094_5f2bd9de-2c86-40b2-8662-a3eef4821531 53499-1094 HUMAN OTC DRUG Cough and Bronchial Alcohol Free ANTIMONY PENTASULFIDE, BRYONIA ALBA ROOT, DROSERA ROTUNDIFOLIA, EUCALYPTUS GLOBULUS LEAF, IPECAC, SPONGIA OFFICINALIS SKELETON, ROASTED SYRUP ORAL 20040701 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ANTIMONY PENTASULFIDE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; EUCALYPTUS GLOBULUS LEAF; IPECAC; SPONGIA OFFICINALIS SKELETON, ROASTED 8; 3; 3; 3; 4; 3 [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL 53499-1193_749e23ca-412d-4d3d-8443-7f9ccb5179ba 53499-1193 HUMAN OTC DRUG Cough and Bronchial with Zinc ANTIMONY PENTASULFIDE, BRYONIA ALBA ROOT, DROSERA ROTUNDIFOLIA, EUCALYPTUS GLOBULUS LEAF, IPECAC, SPONGIA OFFICINALIS SKELETON, ROASTED, ZINC GLUCONATE SYRUP ORAL 20040701 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ANTIMONY PENTASULFIDE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; EUCALYPTUS GLOBULUS LEAF; IPECAC; SPONGIA OFFICINALIS SKELETON, ROASTED; ZINC GLUCONATE 8; 3; 3; 3; 4; 3; 1 [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL 53499-1233_5ebe677a-7e60-4365-9de9-7408120a5a58 53499-1233 HUMAN OTC DRUG Natrum muriaticum Natrum muriaticum TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. SODIUM CHLORIDE 6 [hp_X]/1 53499-1271_d387eca6-0922-4567-8c78-fa16ba7d3ae8 53499-1271 HUMAN OTC DRUG Natrum muriaticum Natrum muriaticum TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. SODIUM CHLORIDE 30 [hp_C]/1 53499-1272_70acc5c4-4007-40e1-9932-64ccb643ce4d 53499-1272 HUMAN OTC DRUG Natrum muriaticum Natrum muriaticum TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. SODIUM CHLORIDE 30 [hp_X]/1 53499-1333_01b65e9f-4c3c-45b3-876d-a386fcb24465 53499-1333 HUMAN OTC DRUG Allium cepa Allium cepa TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ONION 6 [hp_X]/1 53499-1371_b5b57154-f988-4771-a8b6-36f57724cbb0 53499-1371 HUMAN OTC DRUG Allium cepa Allium cepa TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ONION 30 [hp_C]/1 53499-1372_c8162ee7-edc4-4e7f-958d-25133bece855 53499-1372 HUMAN OTC DRUG Allium cepa Allium cepa TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ONION 30 [hp_X]/1 53499-1390_7d80d4a3-d9ec-4dc3-b41d-6519aab11da7 53499-1390 HUMAN OTC DRUG ALPHA SH SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS TABLET SUBLINGUAL 20110818 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. GOLDENSEAL; POTASSIUM CHLORIDE; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE 6; 3; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 53499-1833_0f3f98d2-e6e7-4a2c-8646-1a8c4203705c 53499-1833 HUMAN OTC DRUG Nux vomica Nux vomica TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. STRYCHNOS NUX-VOMICA SEED 6 [hp_X]/1 53499-1871_8655cbb5-4f43-48c0-ba42-b066e031d0fd 53499-1871 HUMAN OTC DRUG Nux vomica Nux vomica TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Holding Co STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/1 53499-1872_6f1ea265-8b4b-4f38-8667-b128e9a2b84c 53499-1872 HUMAN OTC DRUG Nux vomica Nux vomica TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. STRYCHNOS NUX-VOMICA SEED 30 [hp_X]/1 53499-2390_a4116476-309e-48c5-b72e-d427419ef276 53499-2390 HUMAN OTC DRUG MIGRAIDE CYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, GELSEMIUM SEMPERVIRENS ROOT, IRIS VERSICOLOR ROOT, SANGUINARIA CANADENSIS ROOT TABLET SUBLINGUAL 20110818 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. BLACK COHOSH; CYCLAMEN PURPURASCENS TUBER; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; SANGUINARIA CANADENSIS ROOT 3; 3; 3; 2; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 53499-2590_a2ac0302-479a-45f9-9159-8a250ad2ae7d 53499-2590 HUMAN OTC DRUG Allergiemittel CARDIOSPERMUM HALICACABUM FLOWERING TOP, GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT TABLET SUBLINGUAL 20110818 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. CARDIOSPERMUM HALICACABUM FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; LUFFA OPERCULATA FRUIT 3; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 53499-2798_7d5ce326-c7fd-4a62-8ca2-230659e88758 53499-2798 HUMAN OTC DRUG SCIATIC AIDE ARSENIC TRIOXIDE, CHAMOMILE, CITRULLUS COLOCYNTHIS FRUIT PULP, SULFUR TABLET SUBLINGUAL 20110818 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. ARSENIC TRIOXIDE; CHAMOMILE; CITRULLUS COLOCYNTHIS FRUIT PULP; SULFUR 12; 3; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 53499-2871_62fffde1-6c22-43c9-a56b-9904127b2c75 53499-2871 HUMAN OTC DRUG Antimonium tartaricum Antimonium tartaricum TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. TIN 30 [hp_C]/1 53499-2872_fece5415-9902-4012-a854-acf782ace135 53499-2872 HUMAN OTC DRUG Antimonium tartaricum Antimonium tartaricum TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. TIN 30 [hp_X]/1 53499-3533_0d45b6e8-a6a8-4442-8ac2-f8840f3183f9 53499-3533 HUMAN OTC DRUG Arnica Montana Arnica Montana TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Holding Co ARNICA MONTANA 6 [hp_X]/1 53499-3571_1ffac4c5-f47f-469c-ad54-93be8b0460cf 53499-3571 HUMAN OTC DRUG Arnica Montana Arnica Montana TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Holding Co ARNICA MONTANA 30 [hp_C]/1 53499-3572_7ad1f661-c076-4aa6-9730-e35a9caee433 53499-3572 HUMAN OTC DRUG Arnica Montana Arnica Montana TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Holding Co ARNICA MONTANA 30 [hp_X]/1 53499-4098_4f06161f-ec87-4276-82ff-f604b55289dd 53499-4098 HUMAN OTC DRUG Bronchitis and Asthma Aide ACONITUM NAPELLUS, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN TABLET SUBLINGUAL 20110818 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. ACONITUM NAPELLUS; CALCIUM SULFIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN 3; 12; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 53499-4633_9219f57f-22df-4e90-bf52-b1d77134c128 53499-4633 HUMAN OTC DRUG Rhus toxicodendron Rhus toxicodendron TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. TOXICODENDRON PUBESCENS LEAF 6 [hp_X]/1 53499-4671_7ae938a4-e92d-4c63-ac9f-f4698cbed3bd 53499-4671 HUMAN OTC DRUG Rhus toxicodendron Rhus toxicodendron TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. TOXICODENDRON PUBESCENS LEAF 30 [hp_C]/1 53499-4672_e044fda3-6b2e-46b4-be66-7aca71c9a2fa 53499-4672 HUMAN OTC DRUG Rhus toxicodendron Rhus toxicodendron TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. TOXICODENDRON PUBESCENS LEAF 30 [hp_X]/1 53499-5090_b3b56455-75dd-4023-bdca-8b10aed73d5e 53499-5090 HUMAN OTC DRUG Arniflora ARNICA MONTANA GEL TOPICAL 20110101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ARNICA MONTANA 1 [hp_X]/28g 53499-5144_b43350fd-9afd-40bb-9bb4-812dbc29b708 53499-5144 HUMAN OTC DRUG Umcka Coldcare Cherry Pelargonium sidoides TABLET, CHEWABLE ORAL 20110824 UNAPPROVED HOMEOPATHIC Nature's Way Holding Co PELARGONIUM SIDOIDES ROOT 1 [hp_X]/1 53499-5145_a74b9d04-27c7-476a-b36f-c2a32a5e3913 53499-5145 HUMAN OTC DRUG Umcka ColdCare Mint Chewable Pelargonium sidoides TABLET, CHEWABLE ORAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/1 53499-5146_e80d20dd-bef0-4400-80ba-0ddeea16a630 53499-5146 HUMAN OTC DRUG Umcka Coldcare Lemon Pelargonium sidoides POWDER ORAL 20090701 UNAPPROVED HOMEOPATHIC Nature's Way Holding Co. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/5g 53499-5148_14bac7e2-6862-4cc1-9bf9-020904bd4bf3 53499-5148 HUMAN OTC DRUG Umcka Cold Flu Berry Aconitum napellus, Bryonia alba, Eucalyptus globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Ipecacuanha, Pelargonium sidoides, Phosphorus SYRUP ORAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PELARGONIUM SIDOIDES ROOT; PHOSPHORUS 4; 4; 2; 2; 4; 3; 1; 6 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL 53499-5149_61c86ce0-f612-45ee-80cf-ef1a4a4a5150 53499-5149 HUMAN OTC DRUG Umcka Cold Flu Sugar Free Orange Aconitum napellus, Bryonia alba, Eucalyptus globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Ipecacuanha, Pelargonium sidoides, Phosphorus SYRUP ORAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PELARGONIUM SIDOIDES ROOT; PHOSPHORUS 4; 4; 2; 2; 4; 3; 1; 6 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL 53499-5159_46d7e355-1c81-4797-8d34-ac9d33562646 53499-5159 HUMAN OTC DRUG Umcka Cold Flu Berry Pelargonium sidoides, Aconitum Napellus, Bryonia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus TABLET, CHEWABLE ORAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PELARGONIUM SIDOIDES ROOT; PHOSPHORUS 4; 4; 2; 2; 4; 3; 1; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 53499-5161_7014243b-b83b-47fd-a1b6-2b1f642aacab 53499-5161 HUMAN OTC DRUG Umcka Cold Flu Orange Pelargonium sidoides, Aconitum Napellus, Bry1onia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus TABLET, CHEWABLE ORAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PELARGONIUM SIDOIDES ROOT; PHOSPHORUS 4; 4; 2; 2; 4; 3; 1; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 53499-5190_6f061e98-7fed-462a-ad61-7fa987361f87 53499-5190 HUMAN OTC DRUG Califlora Calendula officinalis GEL TOPICAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/78g 53499-5270_abe1caef-dadc-4665-870d-2acc0baf42fb 53499-5270 HUMAN OTC DRUG Umcka Original ColdCare Pelargonium sidoides LIQUID ORAL 20090202 UNAPPROVED HOMEOPATHIC Nature's Way Holding Co. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/30mL 53499-5271_ea8a3ee2-e6d9-4150-8e92-d8af46051500 53499-5271 HUMAN OTC DRUG Umcka ColdCare Alcohol-Free Pelargonium sidoides LIQUID ORAL 20090202 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/30mL 53499-5272_a9fe7aa2-0681-413f-9cad-ff42f0a0bfe3 53499-5272 HUMAN OTC DRUG Umcka Menthol Pelargonium sidoides SYRUP ORAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/120mL 53499-5273_b2e81b4c-67d8-4173-86fb-2620a6c63a55 53499-5273 HUMAN OTC DRUG Umcka ColdCare Alcohol Free Cherry Pelargonium sidoides SYRUP ORAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/240mL 53499-5290_1f8b16fe-04ce-437e-a0be-f7744a682ddc 53499-5290 HUMAN OTC DRUG Triflora Symphytum Officinale, Rhus Toxicodendron, Ledum Palustre GEL TOPICAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. COMFREY ROOT; LEDUM PALUSTRE TWIG; TOXICODENDRON PUBESCENS LEAF 1; 1; 3 [hp_X]/78g; [hp_X]/78g; [hp_X]/78g 53499-5347_337b4933-4248-482d-8d23-ca6219b788ee 53499-5347 HUMAN OTC DRUG Umcka FastActives Cherry Pelargonium sidoides POWDER ORAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/700mg 53499-5348_f9ca8260-3d40-4395-885d-5558f353f16d 53499-5348 HUMAN OTC DRUG Umcka ColdCare FastActives Mint-Menthol Pelargonium sidoides POWDER ORAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/700mg 53499-5349_6445f735-6471-4212-8109-f3af55018cb9 53499-5349 HUMAN OTC DRUG Umcka FastActives Berry Pelargonium sidoides, Aconitum Napellus, Bryonia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus POWDER ORAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PELARGONIUM SIDOIDES ROOT; PHOSPHORUS 4; 4; 2; 4; 3; 1; 6 [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg 53499-5390_08ced114-451d-4a0d-b837-46dfd32edc6a 53499-5390 HUMAN OTC DRUG Ssssting Stop Echinacea Angustifolia, Ledum Palustre Twig, Urtica Dioica, GEL TOPICAL 20040701 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. ECHINACEA ANGUSTIFOLIA; LEDUM PALUSTRE TWIG; URTICA DIOICA 1; 1; 1 [hp_X]/78g; [hp_X]/78g; [hp_X]/78g 53499-5492_d64d72bb-95cb-4bab-bfa0-ecf64111e0cc 53499-5492 HUMAN OTC DRUG Sports For Trauma Bellis Perennis, Hypericum Perfomatum,Toxicodendron Pubscens Leaf, Ruta Graveolens Flowering Top GEL TOPICAL 20040701 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. BELLIS PERENNIS; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 1; 2; 1; 3 [hp_X]/71g; [hp_X]/71g; [hp_X]/71g; [hp_X]/71g 53499-5533_dea76321-b245-49c6-bc4f-84f0944ca24c 53499-5533 HUMAN OTC DRUG Belladonna Belladonna TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. ATROPA BELLADONNA 6 [hp_X]/1 53499-5553_ff2cb8c7-9094-4911-bdee-6c69df4d3a82 53499-5553 HUMAN OTC DRUG SambiFlu Aconitum napellus, Bryonia alba, Eucalyptus globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Ipecacuanha, Phosphorus, Sambucus nigra SYRUP ORAL 20090901 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP 4; 4; 2; 2; 4; 3; 6; 3 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL 53499-5571_b1cf25c1-64ab-4e54-b49e-6ca4aadd27d1 53499-5571 HUMAN OTC DRUG Belladonna 30C Belladonna TABLET SUBLINGUAL 20040704 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. ATROPA BELLADONNA 30 [hp_C]/1 53499-5572_9d0cbfc7-cfd0-49de-9adc-55f09132e1a2 53499-5572 HUMAN OTC DRUG Belladonna Belladonna TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. ATROPA BELLADONNA 30 [hp_X]/1 53499-5794_7fceb1d3-def9-4d05-ada1-672423b8e44e 53499-5794 HUMAN OTC DRUG Umcka ColdCare Sugar Free Grape Pelargonium sidoides SYRUP ORAL 20060901 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/120mL 53499-5799_0cf783ed-ad4e-45f0-b1c9-c6ea73d14894 53499-5799 HUMAN OTC DRUG SAMBUCUS FLUCARE ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOP LOZENGE ORAL 20111001 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP 4; 4; 2; 2; 4; 3; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 53499-5803_825755df-efbf-497c-80d1-b3ec054f82f0 53499-5803 HUMAN OTC DRUG SAMBUCUS FLUCARE ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOP SYRUP ORAL 20111025 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP 4; 4; 2; 2; 4; 3; 6; 3 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 53499-5845_32e0c7eb-e941-4dfe-969d-8df0b67693d0 53499-5845 HUMAN OTC DRUG Umcka Elderberry Umcka Elderberry SYRUP ORAL 20121001 UNAPPROVED HOMEOPATHIC Nature's Way Holding Co ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PELARGONIUM SIDOIDES ROOT; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP 4; 4; 2; 2; 4; 3; 1; 6; 3 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL 53499-5933_f4c30f9e-f3f2-4ba2-9340-07e81f1abb03 53499-5933 HUMAN OTC DRUG Sepia Sepia TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. SEPIA OFFICINALIS JUICE 6 [hp_X]/1 53499-5971_6650a88d-503c-4911-b3c6-755c4fd2dc66 53499-5971 HUMAN OTC DRUG Sepia Sepia TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. SEPIA OFFICINALIS JUICE 30 [hp_C]/1 53499-5972_f56e5909-73ac-418d-9696-a1c9856c8a1e 53499-5972 HUMAN OTC DRUG Sepia Sepia TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. SEPIA OFFICINALIS JUICE 30 [hp_X]/1 53499-6333_8089deac-fb45-4421-81da-1d78b7e8d8c8 53499-6333 HUMAN OTC DRUG Ignatia amara Ignatia amara TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. STRYCHNOS IGNATII SEED 6 [hp_X]/1 53499-6371_0057cc8e-9fbe-4970-beab-32f17f07ed6f 53499-6371 HUMAN OTC DRUG Ignatia amara Ignatia amara TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. STRYCHNOS IGNATII SEED 30 [hp_C]/1 53499-6372_d61ad760-2c69-449b-91ee-1885c3e799e3 53499-6372 HUMAN OTC DRUG Ignatia amara Ignatia amara TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. STRYCHNOS IGNATII SEED 30 [hp_X]/1 53499-7133_250a2c3d-29af-40a9-83fb-e948204bb3c9 53499-7133 HUMAN OTC DRUG Sulphur SULFUR TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. SULFUR 6 [hp_X]/1 53499-7171_a5dba6dd-10b5-46ec-ac20-cd9e26f13fdf 53499-7171 HUMAN OTC DRUG Sulphur 30C SULFUR TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. SULFUR 30 [hp_C]/1 53499-7172_d3a28599-0faa-49ef-be78-c6a493443de3 53499-7172 HUMAN OTC DRUG Sulphur SULFUR TABLET SUBLINGUAL 20040701 UNAPPROVED HOMEOPATHIC Nature's Way Products, Inc. SULFUR 30 [hp_X]/1 53499-7233_d5ac9e32-93cc-42ef-a9c4-8a8f040ed4b5 53499-7233 HUMAN OTC DRUG Kali bichromicum Kali bichromicum TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. POTASSIUM DICHROMATE 6 [hp_X]/1 53499-7271_6ef911fc-47d5-4a6f-8941-028e61ba30e5 53499-7271 HUMAN OTC DRUG Kali bichromicum Kali bichromicum TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. POTASSIUM DICHROMATE 30 [hp_C]/1 53499-7272_c197c481-9fa6-444f-bcaf-83393be663f4 53499-7272 HUMAN OTC DRUG Kali bichromicum Kali bichromicum TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. POTASSIUM DICHROMATE 30 [hp_X]/1 53499-8333_3033a107-67f1-480f-8202-571a101b4615 53499-8333 HUMAN OTC DRUG Thuja occidentalis Thuja occidentalis TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. CEDAR LEAF OIL 6 [hp_X]/1 53499-8371_282b6713-c423-4526-ac08-f2a9deed78a8 53499-8371 HUMAN OTC DRUG Thuja occidentalis Thuja occidentalis TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. CEDAR LEAF OIL 30 [hp_C]/1 53499-8372_9dd916b5-9257-4e39-b00d-67847c433e97 53499-8372 HUMAN OTC DRUG Thuja occidentalis Thuja occidentalis TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. CEDAR LEAF OIL 30 [hp_X]/1 53499-8971_bd6eadd9-a6ca-4ca7-9e17-c7429fe72ad1 53499-8971 HUMAN OTC DRUG Lycopodium clavatum Lycopodium clavatum TABLET SUBLINGUAL 20060101 20150210 UNAPPROVED HOMEOPATHIC Natures Way Holding Co. LYCOPODIUM CLAVATUM SPORE 30 [hp_C]/1 53499-8972_f2d44ede-2454-47ce-a108-298e5b3d73d9 53499-8972 HUMAN OTC DRUG Lycopodium clavatum Lycopodium clavatum TABLET SUBLINGUAL 20060101 20150131 UNAPPROVED HOMEOPATHIC Nature's Way Holding Co. LYCOPODIUM CLAVATUM SPORE 30 [hp_X]/1 53507-001_755d593f-f508-47f8-b91f-145880662d08 53507-001 HUMAN OTC DRUG DEODORANT Triclocarban SOAP TOPICAL 20121024 OTC MONOGRAPH NOT FINAL part333A Shanghai Kangyi Tourism Products Co., Ltd. TRICLOCARBAN .29 g/100g 53510-000_4df32bbd-7ce9-4391-855a-96d79d7e9919 53510-000 HUMAN OTC DRUG DELUXE Dish DETERGENT TRICLOSAN SOAP TOPICAL 20140930 OTC MONOGRAPH NOT FINAL part333E Showline, Inc. TRICLOSAN 1 mg/mL 53519-618_97097f6c-48c0-40d1-80ab-21c0cc0d011b 53519-618 HUMAN OTC DRUG Joints and Muscles Pain Relieving Camphor (Natural) PATCH TOPICAL 20130106 OTC MONOGRAPH NOT FINAL part348 Chongqing Yilin Science and Technology Co., Ltd. CAMPHOR (NATURAL) 22.5 mg/1 53550-001_2f02c0ed-659f-425f-bc7e-fa78038a5129 53550-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19790101 UNAPPROVED MEDICAL GAS M & A Welding Supply Co., Inc OXYGEN 995 mL/L 53567-0101_e123425c-cbac-47c2-b511-b07c4b14dee5 53567-0101 HUMAN OTC DRUG SuperSmile Professional Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110628 OTC MONOGRAPH FINAL part355 ROBELL RESEARCH, INC. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 53567-0706_383d811d-d368-4dd4-a33a-a759d8ca9bc5 53567-0706 HUMAN OTC DRUG Supersmile Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL; ORAL 20060101 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g 53567-0717_16705b72-55a9-4f0e-8e78-9279ef156970 53567-0717 HUMAN OTC DRUG Supersmile Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL; ORAL 20060101 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g 53567-0722_845e5e0a-1ada-45f2-a1f0-dd7c7ba99cb0 53567-0722 HUMAN OTC DRUG Supersmile Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL; ORAL 20060101 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g 53567-0723_9ea5e166-9c10-45d2-9938-0f89370c7cf1 53567-0723 HUMAN OTC DRUG Supersmile Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL; ORAL 20060101 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g 53567-6044_1d9c0c38-cbc7-4aef-b188-ecc3898bb42d 53567-6044 HUMAN OTC DRUG SuperSmile Professional Whitening Toothpaste PASTE, DENTIFRICE DENTAL 20110628 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE .83 g/100g 53590-100_198ef84d-7087-4fd7-bceb-d39f423f48f5 53590-100 HUMAN OTC DRUG MOZI-Q Ledum Palustre Twig, Urtica Urens, Simaba Cedron Seed, Delphinium Staphisagria Seed, Grindelia Hirsutula Flowering Top TABLET, CHEWABLE ORAL 20121015 UNAPPROVED HOMEOPATHIC Xerion Dispensary Ltd. DELPHINIUM STAPHISAGRIA SEED; GRINDELIA HIRSUTULA FLOWERING TOP; LEDUM PALUSTRE TWIG; SIMABA CEDRON SEED; URTICA URENS 4; 6; 3; 4; 6 [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1 53590-102_528f3958-38f7-4179-89e1-4a5220937375 53590-102 HUMAN OTC DRUG MOZI-Qfor kids and infa for kids and infants Ledum Palustre Twig, Urtica Urens, Simaba Cedron Seed, Delphinium Staphisagria Seed, Grindelia Hirsutula Flowering Top LIQUID ORAL 20140201 UNAPPROVED HOMEOPATHIC Xerion Dispensary Ltd. DELPHINIUM STAPHISAGRIA SEED; GRINDELIA HIRSUTULA FLOWERING TOP; LEDUM PALUSTRE TWIG; SIMABA CEDRON SEED; URTICA URENS 4; 6; 3; 4; 6 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 53590-104_556eb037-1b56-41d0-88dd-052ce3bd5580 53590-104 HUMAN OTC DRUG MOZI-Q Ledum Palustre Twig, Urtica Urens, Simaba Cedron Seed, Delphinium Staphisagria Seed, Grindelia Hirsutula Flowering Top LOTION TOPICAL 20140201 UNAPPROVED HOMEOPATHIC Xerion Dispensary Ltd. DELPHINIUM STAPHISAGRIA SEED; GRINDELIA HIRSUTULA FLOWERING TOP; LEDUM PALUSTRE TWIG; SIMABA CEDRON SEED; URTICA URENS 4; 6; 3; 4; 6 [hp_X]/50g; [hp_C]/50g; [hp_X]/50g; [hp_C]/50g; [hp_X]/50g 53598-003_c86191d5-b44f-4440-bd05-3aad8d90413b 53598-003 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, COATED ORAL 20130402 OTC MONOGRAPH NOT FINAL part343 Bonita Pharmaceuticals LLC ACETAMINOPHEN 500 mg/1 53598-004_d602b60d-906b-4e13-ba20-185406d5739a 53598-004 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride TABLET, COATED ORAL 20130521 OTC MONOGRAPH FINAL part341 Bonita Pharmaceuticals LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 53598-007_95fb86dd-1cd2-4fbe-9395-493cb8d932ec 53598-007 HUMAN OTC DRUG Instant Hand Sanitizer Gel Ethyl Alcohol GEL TOPICAL 20130912 OTC MONOGRAPH NOT FINAL part333E Bonita Pharmaceuticals LLC ALCOHOL 18.6 mL/30mL 53603-1001_76305dfe-721d-4d9b-ad9b-0569bec13c33 53603-1001 HUMAN OTC DRUG Instant Hand Sanitizer Blue Raspberry ETHYL ALCOHOL GEL TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-1002_28c3f21d-0e80-4600-ac64-52b875d14261 53603-1002 HUMAN OTC DRUG Instant Hand Sanitizer Candy Apple ETHYL ALCOHOL GEL TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-1003_14cdfbab-b4ac-4eec-862a-d963764ac6a6 53603-1003 HUMAN OTC DRUG Instant Hand Sanitizer Fresh Aloe ETHYL ALCOHOL GEL TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-1004_aae8b9e2-50f5-4acc-8c85-ccbb00299545 53603-1004 HUMAN OTC DRUG Instant Hand Sanitizer Lemon Drop ETHYL ALCOHOL GEL TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-1005_4b7d407d-6bcd-46a9-b799-c0b99d38d755 53603-1005 HUMAN OTC DRUG Instant Hand Sanitizer Sugar Plum ETHYL ALCOHOL GEL TOPICAL 20130516 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-1006_ce1419ab-8d7c-4e84-b9c9-fb302a191f60 53603-1006 HUMAN OTC DRUG Instant Hand Sanitizer Twisted Peppermint ETHYL ALCOHOL GEL TOPICAL 20130516 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-1007_16931f00-20bd-4f99-b05e-882b0353d546 53603-1007 HUMAN OTC DRUG Instant Hand Sanitizer Chinese Cherry Blossom ETHYL ALCOHOL GEL TOPICAL 20130516 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-1008_9f6f1894-2716-418c-944c-e7201d3d5861 53603-1008 HUMAN OTC DRUG Instant Hand Sanitizer Vanilla Noel ETHYL ALCOHOL GEL TOPICAL 20130516 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-1009_c91f4d44-0e19-4551-8460-94fc6d617d08 53603-1009 HUMAN OTC DRUG Simply Clean Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20141125 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-1010_3f819abb-2fe8-49b5-8ba8-f6920b4aebe6 53603-1010 HUMAN OTC DRUG Simply Clean Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-1011_c34125de-3f6a-4100-ade9-1f77c0284278 53603-1011 HUMAN OTC DRUG Simply Clean Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-1012_e217e181-f3ac-4ede-a0bc-d30c372bb971 53603-1012 HUMAN OTC DRUG Simply Clean Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-1013_1a074c20-4fcf-4882-944b-aa7ec9b89065 53603-1013 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-1014_148374df-408d-48bf-9167-965cdcac1b29 53603-1014 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-1015_f571a83c-754d-47df-a7eb-5254565b9712 53603-1015 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-1016_d8652ea3-3094-4fd5-a41c-4675ddb534f8 53603-1016 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-1017_03359f55-e297-4896-a6c4-527c73381b87 53603-1017 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-2001_fd2cdb32-524b-4589-bbee-1d043bd4b291 53603-2001 HUMAN OTC DRUG Instant Hand Sanitizer Blue Raspberry ETHYL ALCOHOL GEL TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-2002_16b25737-a8c0-4270-bdfd-f8cc7ecd7b38 53603-2002 HUMAN OTC DRUG Instant Hand Sanitizer Bubble Gum ETHYL ALCOHOL GEL TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-2003_e2be66b2-ba2f-4861-97b4-45dab38c4743 53603-2003 HUMAN OTC DRUG Instant Hand Sanitizer Lemon Drop ETHYL ALCOHOL GEL TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-2004_66a5c113-5ad5-4df6-a7e0-26bef39d6e68 53603-2004 HUMAN OTC DRUG Instant Hand Sanitizer Strawberry Kiss ETHYL ALCOHOL GEL TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mg/100mL 53603-2005_f6f645b6-4598-4560-a986-3a1d2159d342 53603-2005 HUMAN OTC DRUG Instant Hand Sanitizer Fresh Aloe ETHYL ALCOHOL GEL TOPICAL 20130820 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL 53603-2011_83735c2f-7465-4941-87ff-5c587b6bfd62 53603-2011 HUMAN OTC DRUG Anti-bacterial Blue Raspberry Hand Triclosan SOAP TOPICAL 20121006 OTC MONOGRAPH NOT FINAL part333E BB17, LLC TRICLOSAN .3 g/100mL 53603-2012_8c2f9c88-af45-4144-af58-1d44e7878517 53603-2012 HUMAN OTC DRUG Anti-bacterial Strawberry Kiss Hand Triclosan SOAP TOPICAL 20121006 OTC MONOGRAPH NOT FINAL part333E BB17, LLC TRICLOSAN .3 g/100mL 53603-2013_8d2085df-6ea3-42a9-85b0-5eeaa509d603 53603-2013 HUMAN OTC DRUG Anti-bacterial Lemon Drop Hand Triclosan SOAP TOPICAL 20121006 OTC MONOGRAPH NOT FINAL part333E BB17, LLC TRICLOSAN .3 g/100mL 53603-2014_ddf2a5b8-a5dc-4a5b-84a5-f9345bfa8e22 53603-2014 HUMAN OTC DRUG Anti-bacterial Bubble Gum Hand Triclosan SOAP TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part333E BB17, LLC TRICLOSAN .3 g/100mL 53603-2015_f22b9522-ce4f-4da3-8345-21e9b43ca265 53603-2015 HUMAN OTC DRUG Anti-bacterial Fresh Aloe Hand Triclosan SOAP TOPICAL 20130820 OTC MONOGRAPH NOT FINAL part333E BB17, LLC TRICLOSAN .3 g/100mL 53603-3001_88b59373-7254-413e-b85b-070e2156bb58 53603-3001 HUMAN OTC DRUG ANTIBACTERIAL WIPES Candy Apple benzethonium chloride SWAB TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC BENZETHONIUM CHLORIDE .2 g/100g 53603-3002_14a1d080-0ec1-4cf9-a6f5-b6a4bb225a17 53603-3002 HUMAN OTC DRUG ANTIBACTERIAL WIPES Lemon Drop benzethonium chloride SWAB TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC BENZETHONIUM CHLORIDE .2 g/100g 53603-3003_587eda8d-2818-47f3-8243-eba4f43f3941 53603-3003 HUMAN OTC DRUG ANTIBACTERIAL WIPES Blue Raspberry benzethonium chloride SWAB TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC BENZETHONIUM CHLORIDE .2 g/100g 53603-3004_0dce803a-47d7-42c7-8998-53e3cd498fd8 53603-3004 HUMAN OTC DRUG ANTIBACTERIAL WIPES Fresh Aloe benzethonium chloride SWAB TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC BENZETHONIUM CHLORIDE .2 g/100g 53603-4001_a7243afd-3136-489d-b601-dc121e56a978 53603-4001 HUMAN OTC DRUG ANTIBACTERIAL MINI WIPES Blue Raspberry benzethonium chloride SWAB TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC BENZETHONIUM CHLORIDE .2 g/100g 53603-4002_a3d1f732-a4eb-430d-aa8e-bb341985dd86 53603-4002 HUMAN OTC DRUG ANTIBACTERIAL MINI WIPES Candy Apple benzethonium chloride SWAB TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC BENZETHONIUM CHLORIDE .2 g/100g 53603-4003_7b7ea1e2-9077-47b7-a988-441c50302e26 53603-4003 HUMAN OTC DRUG ANTIBACTERIAL MINI WIPES Fresh Aloe benzethonium chloride SWAB TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC BENZETHONIUM CHLORIDE .2 g/100g 53603-4004_8a007018-d5f2-479a-adbb-4962a893eb17 53603-4004 HUMAN OTC DRUG ANTIBACTERIAL MINI WIPES Lemon Drop benzethonium chloride SWAB TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC BENZETHONIUM CHLORIDE .2 g/100g 53614-001_e53f15dd-98b1-4fc2-82c8-038bb057acf0 53614-001 HUMAN OTC DRUG ZHONG HUA JIU PATCH MENTHOL PATCH TOPICAL 20030515 OTC MONOGRAPH NOT FINAL part348 Wuhan Chinese Moxibustion Technology Development Co.; Ltd. MENTHOL 10 mg/1000mg 53620-101_093cb8ba-cb5f-4837-8de7-42025df96c24 53620-101 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 19550101 UNAPPROVED MEDICAL GAS Esquire Gas Products Company, Inc CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 53622-001_32ffc79e-0633-477c-b0b7-975ba614c8ce 53622-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19820101 UNAPPROVED MEDICAL GAS Regional Home Care, Inc. dba North Atlantic Medical OXYGEN 99 L/100L 53633-100_80a6972e-a1c8-49fa-99e1-5628163ba28f 53633-100 HUMAN OTC DRUG Marly Skin Guard Dimethicone AEROSOL, FOAM TOPICAL 20121008 OTC MONOGRAPH NOT FINAL part356 Marly Skin NA Inc DIMETHICONE 1 mg/100mL 53634-010_8cc0d481-6249-4838-86e2-30a3f5c75541 53634-010 HUMAN OTC DRUG Malin and Goetz Acne Treatment sulfur,salicylic acid CREAM TOPICAL 20121105 OTC MONOGRAPH FINAL part333D Malin and Goetz Inc SULFUR 10 g/100mL 53634-152_96e96392-80f2-45f3-a3ae-d52a257f87a0 53634-152 HUMAN OTC DRUG Malin and Goetz SPF 15 face moisturizer Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20121002 OTC MONOGRAPH NOT FINAL part352 Malin & Goetz Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 2 g/100mL; g/100mL; g/100mL 53634-254_42a636d3-b93f-4fad-ae6c-61be99e2afec 53634-254 HUMAN OTC DRUG Malin and Goetz SPF 30 Face Moisturizer avobenzone, homosalate, octinoxate, octisalate, and oxybenzone CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Malin + Goetz AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 100; 75; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 53645-1000_bd7a27d1-ffb1-4cbb-ae8f-cf30c92ce46a 53645-1000 HUMAN OTC DRUG Arnica Arnica LIQUID ORAL 20121113 UNAPPROVED HOMEOPATHIC True Botanica, LLC ARNICA MONTANA FLOWER 6 [hp_X]/50mL 53645-1001_c08fef41-f4d1-4104-9d51-c20fbf76311c 53645-1001 HUMAN OTC DRUG Arnica Arnica montana GLOBULE ORAL 20130902 UNAPPROVED HOMEOPATHIC True Botanica, LLC ARNICA MONTANA 30 [hp_X]/23g 53645-1020_75fb53e3-6e68-4359-9469-d2ef1f807c1e 53645-1020 HUMAN OTC DRUG Aurum Metallicum Aurum Metallicum LIQUID ORAL 20130121 UNAPPROVED HOMEOPATHIC True Botanica, LLC GOLD 6 [hp_X]/50mL 53645-1021_06973bc4-b951-4910-b1d4-16bae53ef0f7 53645-1021 HUMAN OTC DRUG Aurum Metallicum Aurum Metallicum GLOBULE ORAL 20130628 UNAPPROVED HOMEOPATHIC True Botanica, LLC GOLD 30 [hp_X]/23g 53645-1030_cf297cf2-2c99-466f-a1f7-0887b976fd9f 53645-1030 HUMAN OTC DRUG Argentum Metallicum Argentum Metallicum LIQUID ORAL 20130129 UNAPPROVED HOMEOPATHIC True Botanica, LLC SILVER 6 [hp_X]/50mL 53645-1031_26587dbc-080a-4cb7-84a7-a74f45cbb82f 53645-1031 HUMAN OTC DRUG Argentum Metallicum Argentum Metallicum GLOBULE ORAL 20130628 UNAPPROVED HOMEOPATHIC True Botanica, LLC SILVER 30 [hp_X]/23g 53645-1040_82ed880a-08ea-4826-a087-5b5fb5d9f983 53645-1040 HUMAN OTC DRUG Adrenal Adrenal LIQUID ORAL 20130208 UNAPPROVED HOMEOPATHIC True Botanica, LLC BOS TAURUS ADRENAL GLAND 6 [hp_X]/50mL 53645-1050_7b2ef0fb-88e8-477b-bce6-a6725aca7fc5 53645-1050 HUMAN OTC DRUG Cuprum Metallicum Cuprum Metallicum CREAM TOPICAL 20130227 UNAPPROVED HOMEOPATHIC True Botanica, LLC COPPER 6 [hp_X]/50mL 53645-1060_ae9968f1-c7b7-4be1-91e3-8de15b4b8ec9 53645-1060 HUMAN OTC DRUG Stannum Metallicum Stannum Metallicum CREAM TOPICAL 20130312 UNAPPROVED HOMEOPATHIC True Botanica, LLC TIN 6 [hp_X]/50mL 53645-1070_fd03e4df-c0eb-4e48-a4c7-4effdc664707 53645-1070 HUMAN OTC DRUG Argentum Metallicum Argentum Metallicum CREAM TOPICAL 20130312 UNAPPROVED HOMEOPATHIC True Botanica, LLC SILVER 6 [hp_X]/50mL 53645-1080_2a74d35e-9b7d-4c39-bb5f-df55d70f564a 53645-1080 HUMAN OTC DRUG Ferrum Metallicum Ferrum Metallicum CREAM TOPICAL 20130312 UNAPPROVED HOMEOPATHIC True Botanica, LLC IRON 6 [hp_X]/50mL 53645-1090_0dc86c33-f12d-4ebc-91fb-77f947f39c55 53645-1090 HUMAN OTC DRUG Lycopodium Clavatum Lycopodium Clavatum GLOBULE ORAL 20131007 UNAPPROVED HOMEOPATHIC True Botanica, LLC LYCOPODIUM CLAVATUM SPORE 6 [hp_X]/23g 53645-1091_13856b44-f38a-4825-858b-3d7d19d4597d 53645-1091 HUMAN OTC DRUG Lycopodium Clavatum Lycopodium Clavatum GLOBULE ORAL 20131007 UNAPPROVED HOMEOPATHIC True Botanica, LLC LYCOPODIUM CLAVATUM SPORE 30 [hp_X]/23g 53645-1100_a9e9bbac-892d-40f8-8385-bdffce576452 53645-1100 HUMAN OTC DRUG Cuprum Metallicum Cuprum Metallicum GLOBULE ORAL 20130628 UNAPPROVED HOMEOPATHIC True Botanica, LLC COPPER 6 [hp_X]/23g 53645-1110_7c991535-a53d-42bc-8ddb-e90ec7ab7f2c 53645-1110 HUMAN OTC DRUG Belladonna Belladonna GLOBULE ORAL 20130607 UNAPPROVED HOMEOPATHIC True Botanica, LLC ATROPA BELLADONNA 30 [hp_X]/23g 53645-1111_f0848ff6-f094-4012-bd07-e45e205cc1b2 53645-1111 HUMAN OTC DRUG Belladonna Belladonna GLOBULE ORAL 20130607 UNAPPROVED HOMEOPATHIC True Botanica, LLC ATROPA BELLADONNA 6 [hp_X]/23g 53645-1120_32d71f4c-418a-4ce8-acb9-c8f353b65ab7 53645-1120 HUMAN OTC DRUG Antimonium Crudum Antimonium Crudum GLOBULE ORAL 20130902 UNAPPROVED HOMEOPATHIC True Botanica, LLC ANTIMONY TRISULFIDE 6 [hp_X]/23g 53645-1140_f5eb452f-d132-463e-a215-a757d74caec2 53645-1140 HUMAN OTC DRUG Apis Mell. Apis Mell. GLOBULE ORAL 20130620 UNAPPROVED HOMEOPATHIC True Botanica, LLC APIS MELLIFERA VENOM 6 [hp_X]/23g 53645-1141_1e036ad1-6fe8-4fd5-87ad-8eb686be9074 53645-1141 HUMAN OTC DRUG Apis Mell. Apis Mell. 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Plumbum Mel. 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ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE 1000; 325; 1916 mg/1; mg/1; mg/1 53666-403_c5cec0f6-56ff-4544-a932-a133ad26c2d4 53666-403 HUMAN OTC DRUG Alka Seltzer ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20121010 OTC MONOGRAPH FINAL part343 Salimex, S.A. ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE 1000; 325; 1916 mg/1; mg/1; mg/1 53666-408_b09519e5-436d-4e8d-9183-fa3d17a09dc1 53666-408 HUMAN OTC DRUG TABCIN 500 Acetylsalicylic Acid, Phenylephrine Bitartrate, Chlorpheniramine maleate TABLET, EFFERVESCENT ORAL 20130821 OTC MONOGRAPH FINAL part341 Salimex, S.A. ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 500; 2; 8 mg/1; mg/1; mg/1 53666-444_d9d0b2bf-f514-4370-92cb-ecba0e49e9ed 53666-444 HUMAN OTC DRUG TABCIN 500 ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130821 OTC MONOGRAPH FINAL part343 Salimex, S.A. ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 500; 2; 8 mg/1; mg/1; mg/1 53675-100_7abdab3e-6427-49bd-b108-8c898fa8852a 53675-100 HUMAN OTC DRUG ARUBA ALOE ISLAND REMEDY DAILY ULTRA ALOE OCTINOXATE, OXYBENZONE CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 ARUBA ALOE BALM NV OCTINOXATE; OXYBENZONE 7.5; 4.5 mL/100mL; mL/100mL 53675-131_cfb3dd05-e818-4d97-b51f-b5b98655d911 53675-131 HUMAN OTC DRUG Aruba Aloe Deodorant Ladies Extra Dry Aluminum Chlorohydrate LOTION TOPICAL 20070101 OTC MONOGRAPH FINAL part350 Aruba Aloe Balm NV ALUMINUM CHLOROHYDRATE 25 g/100g 53675-132_cc33bfe3-e31b-4ce0-bdd5-443d0f04713e 53675-132 HUMAN OTC DRUG Aruba Aloe Deodorant Men Extra Dry Aluminum Chlorohydrate LOTION TOPICAL 20070101 OTC MONOGRAPH FINAL part350 Aruba Aloe Balm NV ALUMINUM CHLOROHYDRATE 25 g/100g 53675-133_4e409aac-c491-4112-bb9e-ff7ba28b91ca 53675-133 HUMAN OTC DRUG Aruba Aloe Deodorant Men Musk Aluminum Chlorohydrate LOTION TOPICAL 20070101 OTC MONOGRAPH FINAL part350 Aruba Aloe Balm NV ALUMINUM CHLOROHYDRATE 16 g/100g 53675-134_4aa884f3-497e-49d6-b2b7-f34b159994b0 53675-134 HUMAN OTC DRUG Aruba Aloe Deodorant Women Powder Fresh Aluminum Chlorohydrate LOTION TOPICAL 20070101 OTC MONOGRAPH FINAL part350 Aruba Aloe Balm NV ALUMINUM CHLOROHYDRATE 16 g/100g 53675-135_e232833e-1be4-4262-9e22-ddbe5e5fbd07 53675-135 HUMAN OTC DRUG Aruba Aloe Deodorant Women Powder Fresh Aluminum Chlorohydrate LOTION TOPICAL 20070101 OTC MONOGRAPH FINAL part350 Aruba Aloe Balm NV ALUMINUM CHLOROHYDRATE 16 g/100g 53675-140_0d0212db-df23-4ebf-abb5-c1148ffeb320 53675-140 HUMAN OTC DRUG Aruba Aloe Lip Sunscreen and Moisturizer OXYBENZONE, PADIMATE LIPSTICK TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm NV OXYBENZONE; PADIMATE O 3; 8 g/100g; g/100g 53675-150_3b7cec17-9185-4d27-a4c4-1a3c498e82d6 53675-150 HUMAN OTC DRUG Aruba Aloe Very Water Resistant Sunscreen HOMOSALATE, OCTINOXATE, PADIMATE O , OXYBENZONE LOTION TOPICAL 20110605 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm, NV HOMOSALATE; OCTINOXATE; OXYBENZONE; PADIMATE O 8; 7; 3; 4.2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 53675-152_7345afe5-fae3-46c6-8485-e0a739f8dd4e 53675-152 HUMAN OTC DRUG Aruba Aloe Very Water Resistant Sunscreen For Kids SPF 30 HOMOSALATE, OCTINOXATE, PADIMATE O , OXYBENZONE LOTION TOPICAL 20110605 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm, NV HOMOSALATE; OCTINOXATE; OXYBENZONE; PADIMATE O 8; 7; 3; 4.2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 53675-154_1c240b7f-317f-4e06-89dc-198669ab7436 53675-154 HUMAN OTC DRUG Aruba Aloe Very Water Resistant Sunscreen - For Faces SPF 30 HOMOSALATE, OCTINOXATE, PADIMATE O, OXYBENZONE LOTION TOPICAL 20110706 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm NV HOMOSALATE; OCTINOXATE; OXYBENZONE; PADIMATE O 8; 7; 3; 4.2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 53675-155_16307d64-b3e8-4e0f-9170-0fc48c9d9068 53675-155 HUMAN OTC DRUG Aruba Aloe Very Water Resistant Sunscreen SPF 15 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20110708 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm, NV OCTINOXATE; OXYBENZONE 7.5; 4.5 mL/100mL; mL/100mL 53675-157_f712eb74-2f2c-4466-b4fb-06a92181c554 53675-157 HUMAN OTC DRUG Aruba Aloe Very Water Resistant Sunscreen SPF 8 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20110708 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm, NV OCTINOXATE; OXYBENZONE 7; 2 mL/100mL; mL/100mL 53675-158_c7886d9a-475f-45f0-ab6b-15cc3fb35667 53675-158 HUMAN OTC DRUG Aruba Aloe Very Water Resistant Sunscreen SPF 50 OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE, OCTYL SALICYLATE, AVOBENZONE LOTION TOPICAL 20130226 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm NV AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 50; 75; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 53683-0001_9a581f45-ff98-4d2a-8b62-12a5f715fd7f 53683-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19870101 UNAPPROVED MEDICAL GAS MEDOX CORPORATION OXYGEN 99 L/100L 53698-001_3e61be70-5f83-447b-b27e-8b78bdce2518 53698-001 HUMAN OTC DRUG Premium Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20121010 OTC MONOGRAPH NOT FINAL part352 Pro Sun Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 60 mg/100mL; mg/100mL; mg/100mL; mg/100mL 53723-0001_e9303f81-b3d5-4246-bb1e-dbe3a0c11b99 53723-0001 HUMAN OTC DRUG NatuRx Symphytum Officinale, Capsicum Annuum, Ledum Palustre, Colchicum Autumnale, Rhododendron Chrysanthum GEL TOPICAL 20130422 UNAPPROVED HOMEOPATHIC DrsOnlyLab LLC CAPSICUM; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 6; 12; 3; 6; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 53727-101_a2ce1edd-0109-45ca-a77d-3181fbb69a23 53727-101 HUMAN OTC DRUG Always Triple BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Cosmecca Korea Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 5; .5 g/50g; g/50g 53727-102_7e815d78-c112-4d24-a5b0-e396358c4964 53727-102 HUMAN OTC DRUG Premium Gold Mineral BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140528 OTC MONOGRAPH FINAL part352 Cosmecca Korea Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 5; 3 g/50g; g/50g 53727-103_8a40ce01-f850-4711-94fd-5176f75f58d9 53727-103 HUMAN OTC DRUG Time Machine BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140528 OTC MONOGRAPH FINAL part352 Cosmecca Korea Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3; 2 g/30g; g/30g 53727-104_e42fc858-3e3d-4aa9-b106-1dc063b44e94 53727-104 HUMAN OTC DRUG Always Nuddy CC Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140528 OTC MONOGRAPH FINAL part352 Cosmecca Korea Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 4; 1 g/50g; g/50g 53727-105_7a393fd9-a193-4613-bfcc-e86b0c15e93f 53727-105 HUMAN OTC DRUG Always Perfect CC Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140529 OTC MONOGRAPH FINAL part352 Cosmecca Korea Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 5; 3 g/50g; g/50g 53729-0001_d500f555-78a4-4bdf-ade4-6a68c9dd4182 53729-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19790218 UNAPPROVED MEDICAL GAS Buckeye Welding Supply Co Inc. OXYGEN 99 L/100L 53738-0708_53a1237f-f2bd-49d5-8838-a2eb187723c7 53738-0708 HUMAN OTC DRUG RoC Retinol Correxion Deep Wrinkle Daily Moisturizer SPF30 Avobenzone, Homosalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100415 20160801 OTC MONOGRAPH FINAL part352 Johnson & Johnson Sante' Beaute', France AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 30; 50 mg/mL; mg/mL; mg/mL; mg/mL 53738-0710_42ea7df0-1983-4e51-8936-111d594fd046 53738-0710 HUMAN OTC DRUG RoC Multi correxion Lift Anti Gravity Day Moisturizer SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20101201 20160701 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Sante Beaute ? France AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 12; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 53738-0711_5489d56c-1a4d-477d-a288-742388fdd78d 53738-0711 HUMAN OTC DRUG RoC Retinol Correxion Deep Wrinkle Daily Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120828 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Sante Beaute- France AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 30; 50 mg/mL; mg/mL; mg/mL; mg/mL 53738-0712_bdd431d6-b395-458b-be51-70969bfe7555 53738-0712 HUMAN OTC DRUG RoC Multi correxion Lift Anti Gravity Day Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120607 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Sante Beaute- France AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 53738-0713_39857372-0ae4-48a3-9039-982878c273cb 53738-0713 HUMAN OTC DRUG RoC Multi Correxion 5 in 1 Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Sante Beaute- France AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL 53738-0714_33ab7fd3-0a78-4423-b125-8e648b9779e7 53738-0714 HUMAN OTC DRUG RoC Multi Correxion 4 Zone Daily Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20121015 20150513 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Sante Beaute- France AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 80; 40; 30 mg/mL; mg/mL; mg/mL; mg/mL 53738-9905_1fd292ce-d336-43b6-a904-38fb0c74323f 53738-9905 HUMAN OTC DRUG RoC Multi Correxion Avobenzone, Homosalate, Octisalate and Octocrylene CREAM TOPICAL 20091210 20151009 OTC MONOGRAPH FINAL part352 Johnson & Johnson Consumer Sante Beaute France AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 25.3; 77.4; 50.3; 25.3 mg/mL; mg/mL; mg/mL; mg/mL 53742-001_d5b56202-f65a-43aa-916c-ce99e155ddcc 53742-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19991221 UNAPPROVED MEDICAL GAS Cumberland Medical Center- Medical Equipment Services OXYGEN 99 L/100L 53746-077_80781c80-37a9-4b91-8cd9-8346d5d0c7c8 53746-077 HUMAN PRESCRIPTION DRUG Esterified Estrogens and Methyltestosterone Esterified Estrogens and Methyltestosterone TABLET ORAL 20100922 UNAPPROVED DRUG OTHER Amneal Pharmaceuticals, LLC ESTROGENS, CONJUGATED; METHYLTESTOSTERONE .625; 1.25 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 53746-078_80781c80-37a9-4b91-8cd9-8346d5d0c7c8 53746-078 HUMAN PRESCRIPTION DRUG Esterified Estrogens and Methyltestosterone Esterified Estrogens and Methyltestosterone TABLET ORAL 20100922 UNAPPROVED DRUG OTHER Amneal Pharmaceuticals, LLC ESTROGENS, CONJUGATED; METHYLTESTOSTERONE 1.25; 2.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 53746-101_d24ca9d1-7921-41f8-8d72-51141804df29 53746-101 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Amneal Pharmaceuticals of New York, LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 53746-102_d24ca9d1-7921-41f8-8d72-51141804df29 53746-102 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Amneal Pharmaceuticals of New York, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 53746-103_d24ca9d1-7921-41f8-8d72-51141804df29 53746-103 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Amneal Pharmaceuticals of New York, LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 53746-109_8e318f05-245a-47e2-bc25-b020b1e27fe5 53746-109 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 Amneal Pharmaceuticals of New York, LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 53746-110_2f68724f-7982-4019-9fde-1069790d48b4 53746-110 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040746 Amneal Pharmaceuticals of New York, LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 53746-116_829977de-2e8b-4cbe-ae61-8d21d619ccf7 53746-116 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 Amneal Pharmaceuticals of New York, LLC HYDROCODONE BITARTRATE; IBUPROFEN 2.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 53746-117_829977de-2e8b-4cbe-ae61-8d21d619ccf7 53746-117 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 Amneal Pharmaceuticals of New York, LLC HYDROCODONE BITARTRATE; IBUPROFEN 10; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 53746-140_2d202e25-8db1-4a89-baf9-194ce169ebe0 53746-140 HUMAN OTC DRUG Ibuprofen Pain Releiver/ Fever Reducer Ibuprofen TABLET ORAL 20091216 ANDA ANDA071333 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 200 mg/1 53746-142_2d748080-2d3f-4208-8435-0bcab549ffd5 53746-142 HUMAN OTC DRUG Ibuprofen (NSAID) Pain Releiver/ Fever Reducer Ibuprofen TABLET ORAL 20091216 ANDA ANDA072199 Amneal Pharmaceuticals IBUPROFEN 200 mg/1 53746-143_2d202e25-8db1-4a89-baf9-194ce169ebe0 53746-143 HUMAN OTC DRUG Ibuprofen Pain Releiver/ Fever Reducer Ibuprofen TABLET ORAL 20091216 ANDA ANDA071333 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 200 mg/1 53746-144_2d748080-2d3f-4208-8435-0bcab549ffd5 53746-144 HUMAN OTC DRUG Ibuprofen (NSAID) Pain Releiver/ Fever Reducer Ibuprofen TABLET ORAL 20091216 ANDA ANDA072199 Amneal Pharmaceuticals IBUPROFEN 200 mg/1 53746-145_829977de-2e8b-4cbe-ae61-8d21d619ccf7 53746-145 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 Amneal Pharmaceuticals of New York, LLC HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 53746-146_829977de-2e8b-4cbe-ae61-8d21d619ccf7 53746-146 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 Amneal Pharmaceuticals of New York, LLC HYDROCODONE BITARTRATE; IBUPROFEN 5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 53746-178_37996a6b-0ec4-4413-900d-d0dfee08be17 53746-178 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091202 ANDA ANDA078596 Amneal Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 53746-179_37996a6b-0ec4-4413-900d-d0dfee08be17 53746-179 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100226 ANDA ANDA078596 Amneal Pharmaceuticals METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 53746-188_ce690961-8480-4a1b-bba3-5d81545e8dca 53746-188 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Amneal Pharmaceuticals of New York, LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53746-189_ce690961-8480-4a1b-bba3-5d81545e8dca 53746-189 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Amneal Pharmaceuticals of New York, LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53746-190_ce690961-8480-4a1b-bba3-5d81545e8dca 53746-190 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Amneal Pharmaceuticals of New York, LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53746-191_91f51db3-1369-49b1-b785-18e55a23dab4 53746-191 HUMAN OTC DRUG Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever Naproxen Sodium TABLET ORAL 20091125 ANDA ANDA079096 Amneal Pharmaceuticals NAPROXEN SODIUM 220 mg/1 53746-192_91f51db3-1369-49b1-b785-18e55a23dab4 53746-192 HUMAN OTC DRUG Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever Naproxen Sodium TABLET ORAL 20091125 ANDA ANDA079096 Amneal Pharmaceuticals NAPROXEN SODIUM 220 mg/1 53746-193_0dd2d4b5-c4bf-4934-810d-11e6f18ece4b 53746-193 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Amneal Pharmaceuticals NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53746-194_0dd2d4b5-c4bf-4934-810d-11e6f18ece4b 53746-194 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Amneal Pharmaceuticals NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53746-203_939dd7c0-6181-41a3-8d48-43a2886ed823 53746-203 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040777 Amneal Pharmaceuticals, LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 53746-204_9f24a2c3-5fba-4573-a4bf-0b99c8e4f54f 53746-204 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040778 Amneal Pharmaceuticals, LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 53746-218_5ca2ce11-f2d9-490c-b569-e571e41a2e90 53746-218 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 Amneal Pharmaceuticals of New York, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 53746-219_5ca2ce11-f2d9-490c-b569-e571e41a2e90 53746-219 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 Amneal Pharmaceuticals of New York, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 53746-220_5ca2ce11-f2d9-490c-b569-e571e41a2e90 53746-220 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 Amneal Pharmaceuticals of New York, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 53746-253_ec6f6afd-d64b-4607-936a-77d04370edcb 53746-253 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Amneal Pharmaceuticals RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 53746-254_ec6f6afd-d64b-4607-936a-77d04370edcb 53746-254 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Amneal Pharmaceuticals RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 53746-271_06268883-a7a3-4ccc-ad9e-71d8ca2a43db 53746-271 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100225 ANDA ANDA076899 Amneal Pharmaceuticals, LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 53746-272_06268883-a7a3-4ccc-ad9e-71d8ca2a43db 53746-272 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Amneal Pharmaceuticals, LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 53746-464_5c61d290-13c0-480e-b8b5-94416bce4c30 53746-464 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53746-465_5c61d290-13c0-480e-b8b5-94416bce4c30 53746-465 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53746-466_5c61d290-13c0-480e-b8b5-94416bce4c30 53746-466 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53746-511_0d6aff5f-c1b8-4992-809c-3cbef2c1a728 53746-511 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20100802 ANDA ANDA091426 Amneal Pharmaceuticals of New York, LLC SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 53746-514_0d6aff5f-c1b8-4992-809c-3cbef2c1a728 53746-514 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20100802 ANDA ANDA091426 Amneal Pharmaceuticals of New York, LLC SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 53746-515_0d6aff5f-c1b8-4992-809c-3cbef2c1a728 53746-515 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20100802 ANDA ANDA091426 Amneal Pharmaceuticals of New York, LLC SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 53746-542_ea24099d-b8e8-4f00-80f0-655f9527f78f 53746-542 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20130222 ANDA ANDA202128 Amneal Pharmaceuticals of New York, LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 53746-617_d44ac50e-b489-4b58-bbd2-aabbeb8223d7 53746-617 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Amneal Pharmaceuticals of New York, LLC ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 53746-955_96bf1146-b1e0-4f8d-a8c0-976471c2e292 53746-955 HUMAN PRESCRIPTION DRUG Esomeprazole strontium Esomeprazole strontium CAPSULE, DELAYED RELEASE ORAL 20130812 NDA NDA202342 Amneal Pharmaceuticals, LLC ESOMEPRAZOLE STRONTIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 53746-957_96bf1146-b1e0-4f8d-a8c0-976471c2e292 53746-957 HUMAN PRESCRIPTION DRUG Esomeprazole strontium Esomeprazole strontium CAPSULE, DELAYED RELEASE ORAL 20130812 NDA NDA202342 Amneal Pharmaceuticals, LLC ESOMEPRAZOLE STRONTIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 53748-0001_a2c0b63f-689b-45a7-ac0a-071f97f865df 53748-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20031126 UNAPPROVED MEDICAL GAS GoodCare by CPCI OXYGEN 99 L/100L 53773-001_9a230db4-393e-41c1-affd-59927ad06cbd 53773-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Eastern Medical Equipment OXYGEN 99 L/100L 53777-001_9306cf99-1688-4ec6-af1d-c437c81ef581 53777-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19791101 UNAPPROVED MEDICAL GAS Thompson Brothers Supplies, Inc. OXYGEN 990 mL/L 53791-118_e8e1c1f5-cd50-4b7f-bf68-9808e9cb277d 53791-118 HUMAN OTC DRUG Alhua Huogan Pain Relieving Patch Menthol PATCH TOPICAL 20130205 OTC MONOGRAPH NOT FINAL part348 U.S.A. AH LLC MENTHOL 30 mg/1 53798-010_61e8be8a-abd1-4716-9003-56562b2bba94 53798-010 HUMAN OTC DRUG SKYLAKE ORIENTAL HERB EYE Witch Hazel CREAM TOPICAL 20120801 OTC MONOGRAPH FINAL part347 SKYLAKE WITCH HAZEL .02 g/20mL 53807-123_e24d8ff7-8d62-4d25-a337-de885eb47e02 53807-123 HUMAN OTC DRUG Anti-Fungal TOLNAFTATE POWDER TOPICAL 19990316 OTC MONOGRAPH FINAL part333C Rij Pharmaceutical Corporation TOLNAFTATE .45 g/45g 53807-125_a1bae7e7-2204-4712-b687-5273f2aa49c6 53807-125 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide LIQUID ORAL 19990316 OTC MONOGRAPH NOT FINAL part334 Rij Pharmaceutical Corporation MAGNESIUM HYDROXIDE 1200 mg/15mL 53807-126_bbe98d8b-cd81-4ddd-97b6-506e68508836 53807-126 HUMAN OTC DRUG antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part332 Rij Pharmaceutical Corporation ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 53807-129_fd15ec29-3ff3-41bc-914e-0729638f559a 53807-129 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen ELIXIR ORAL 19990316 OTC MONOGRAPH NOT FINAL part343 Rij Pharmaceutical Corporation ACETAMINOPHEN 160 mg/5mL 53807-137_e15ed437-efbe-4fe3-8726-b0a9772e5aad 53807-137 HUMAN OTC DRUG RIGINIC ANTACID LIQUID aluminum hydroxide and magnesium carbonate LIQUID ORAL 20130403 OTC MONOGRAPH FINAL part331 Rij Pharmaceutical Corporation ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 95; 358 mg/15mL; mg/15mL 53807-151_a5bd1783-d2d8-42de-84c0-55bbc7ff7c74 53807-151 HUMAN OTC DRUG antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part332 Rij Pharmaceutical Corporation ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 225; 25; 200 mg/5mL; mg/5mL; mg/5mL 53807-152_bd0d464d-4218-4c04-b48b-a582913b577d 53807-152 HUMAN OTC DRUG Bismuth Bismuth Subsalicylate LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part335 Rij Pharmaceutical Corporation BISMUTH SUBSALICYLATE 262 mg/15mL 53807-158_b5a1a812-bf99-490a-869a-7adc3c9e76be 53807-158 HUMAN OTC DRUG antacid double strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part332 Rij Pharmaceutical Corporation ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 53807-177_e40f40eb-b40b-476b-ab90-3338bb60cd26 53807-177 HUMAN OTC DRUG FERROUS SULFATE FERROUS SULFATE ELIXIR ORAL 19990316 UNAPPROVED DRUG OTHER Rij Pharmaceutical Corporation FERROUS SULFATE 220 mg/5mL 53807-192_cca5cf8f-8f49-42ca-9f6f-2e9ea7b91ec6 53807-192 HUMAN OTC DRUG Pink Bismuth Maximum Strength Bismuth Subsalicylate LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part335 Rij Pharmaceutical Corporation BISMUTH SUBSALICYLATE 525 mg/15mL 53807-196_b526e318-ee7d-47a8-b8c9-50a273258fec 53807-196 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen ELIXIR ORAL 19990316 OTC MONOGRAPH NOT FINAL part343 Rij Pharmaceutical Corporation ACETAMINOPHEN 160 mg/5mL 53807-197_c23d22ea-c043-4f02-a021-2764e71b4753 53807-197 HUMAN OTC DRUG Ri Mucil Psyllium Dietary Fiber Supplement GRANULE, FOR SOLUTION ORAL 19990316 OTC MONOGRAPH NOT FINAL part334 Rij Pharmaceutical Corporation PSYLLIUM HUSK 3.4 g/100g 53807-200_cfa39abb-2405-4264-9868-a7d514653394 53807-200 HUMAN OTC DRUG Fiber Therapy Orange Flavor Psyllium Dietary Fiber Supplement GRANULE, FOR SOLUTION ORAL 19990316 OTC MONOGRAPH NOT FINAL part334 Rij Pharmaceutical Corporation PSYLLIUM HUSK 3.4 g/100g 53807-204_bba30427-4867-42ca-aee9-f7af13a2466e 53807-204 HUMAN OTC DRUG Diphenhydramine Oral Liquid Diphenhydramine Hydrochloride LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 53807-216_be1e524a-2cdf-48ce-a64f-6bb91d9c52e9 53807-216 HUMAN OTC DRUG Docusate Sodium Liquid Docusate sodium LIQUID ORAL 19990316 OTC MONOGRAPH NOT FINAL part334 Rij Pharmaceutical Corporation DOCUSATE SODIUM 10 mg/mL 53807-220_ce46265c-889e-49a8-8c43-e4637be22f56 53807-220 HUMAN OTC DRUG Infants Pain Reliever Acetaminophen SUSPENSION ORAL 19990316 OTC MONOGRAPH NOT FINAL part343 Rij Pharmaceutical Corporation ACETAMINOPHEN 160 mg/1.6mL 53807-401_d7117f12-f07b-4747-ba68-e8d25a5a7135 53807-401 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide LIQUID ORAL 19990316 OTC MONOGRAPH NOT FINAL part334 Rij Pharmaceutical Corporation MAGNESIUM HYDROXIDE 400 mg/5mL 53807-405_b7d29705-d741-4d24-ab70-96e09fe86b1c 53807-405 HUMAN OTC DRUG antacid cherry flavored Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part332 Rij Pharmaceutical Corporation ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 53807-406_d4e8cc66-bd91-4da4-89cd-a416880555ac 53807-406 HUMAN OTC DRUG antacid mint flavored Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part332 Rij Pharmaceutical Corporation ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 53807-408_d3bd6cbb-ef64-4a6b-ada0-b7fbd1a021c7 53807-408 HUMAN OTC DRUG Ritussin Expectorant GUAIFENESIN LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation GUAIFENESIN 100 mg/5mL 53807-409_ca57d666-22b3-4ead-8730-707acc8092ee 53807-409 HUMAN OTC DRUG Ritussin DM DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 53807-422_fd309981-d85e-4c1e-b20b-6ea264550f68 53807-422 HUMAN OTC DRUG Childrens Uniphed Nasal Decongestant Pseudoephedrine hydrochloride LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg/5mL 53807-502_ca1e85d9-5ad4-418b-986d-221723d60378 53807-502 HUMAN OTC DRUG RI MOX Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part332 Rij Pharmaceutical Corporation ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 53807-503_e7b503a9-3037-49f7-b32d-696425d30d99 53807-503 HUMAN OTC DRUG Kao-Bis Bismuth Subsalicylate LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part335 Rij Pharmaceutical Corporation BISMUTH SUBSALICYLATE 262 mg/15mL 53807-515_f0b1a13f-64b2-470d-ad12-f22e0bac38d0 53807-515 HUMAN OTC DRUG Ka Pec Bismuth Subsalicylate LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part335 Rij Pharmaceutical Corporation BISMUTH SUBSALICYLATE 262 mg/15mL 53807-518_e9b9a189-d9e3-42e3-b41c-846a94ebeb37 53807-518 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 19990316 OTC MONOGRAPH NOT FINAL part343 Rij Pharmaceutical Corporation ACETAMINOPHEN 160 mg/5mL 53807-520_a7cc2c34-ff19-4d39-8860-de3b40ace25f 53807-520 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 19990316 OTC MONOGRAPH NOT FINAL part343 Rij Pharmaceutical Corporation ACETAMINOPHEN 160 mg/5mL 53807-521_ecea4929-cbe1-4927-bd81-51e32c9807fc 53807-521 HUMAN OTC DRUG Nite Time Cold Medicine Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 53807-522_d10f79fe-b9d0-45cd-819d-7b7ab9e403cf 53807-522 HUMAN OTC DRUG Nite Time Cold Medicine Cherry Flavor Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 53807-523_0d516b93-f976-4cc3-9f2e-fad6f94bb125 53807-523 HUMAN OTC DRUG Infants GAS DROPS Simethicone SUSPENSION/ DROPS ORAL 19960316 OTC MONOGRAPH FINAL part332 Rij Pharmaceutical Corporation DIMETHICONE 20 mg/.3mL 53807-529_a982e3c8-8673-4b60-b603-1c0c88bd8e99 53807-529 HUMAN OTC DRUG Brom Tapp brompheniramine maleate, phenylephrine HCl LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 53807-530_c5809052-3069-4342-8c97-22e9e09ac7a9 53807-530 HUMAN OTC DRUG Brom Tapp DM brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 53807-531_a8e506ed-dcc8-44e5-afba-067fe7124f6d 53807-531 HUMAN OTC DRUG Cough Formula Cough and Cold dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 53807-538_b0c7a17c-3c1c-40d5-98c7-bf234f77709b 53807-538 HUMAN OTC DRUG Antacid and Antigas Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part332 Rij Pharmaceutical Corporation ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 53808-0104_68a98d1d-a74f-4d43-9ebe-c50795b3975b 53808-0104 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20090701 ANDA ANDA076071 State of Florida DOH Central Pharmacy LISINOPRIL 10 mg/1 53808-0162_d5cbfe16-755c-412f-9926-caa2f8222e07 53808-0162 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET ORAL 20090620 NDA NDA070976 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 53808-0165_dc9c799a-3c8e-4860-891c-fc3fff243a85 53808-0165 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20080501 ANDA ANDA077002 DEPT HEALTH CENTRAL PHARMACY DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 53808-0200_24efe210-73f3-446c-a8d3-88baa1508702 53808-0200 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20090701 ANDA ANDA077955 State of Florida DOH Central Pharmacy AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53808-0203_9798152d-b3b5-4fc6-985e-10b59177464b 53808-0203 HUMAN PRESCRIPTION DRUG ACCOLATE Zafirlukast TABLET, FILM COATED ORAL 20090701 NDA NDA020547 State of Florida DOH Central Pharmacy ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 53808-0205_bac1e923-6161-462a-bfd3-37cfb34a7313 53808-0205 HUMAN PRESCRIPTION DRUG Asacol mesalamine TABLET, DELAYED RELEASE ORAL 20090701 NDA NDA019651 State of Florida DOH Central Pharmacy MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 53808-0207_81b9fca7-f47d-4293-87ae-856c4b1c5f96 53808-0207 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20090701 ANDA ANDA076900 State of Florida DOH Central Pharmacy ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0210_d977e7ce-4bbb-42ba-aad5-ac46ef656206 53808-0210 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20090701 ANDA ANDA072265 State of Florida DOH Central Pharmacy BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 53808-0211_6652f325-aa55-42d6-98a9-8d3684bc3a7f 53808-0211 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20090701 ANDA ANDA089059 State of Florida DOH Central Pharmacy BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 53808-0213_bd3c717d-992b-420d-afd5-fa67e62964f2 53808-0213 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA075310 State of Florida DOH Central Pharmacy BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 53808-0214_6d43cb24-1cea-446c-a8c6-4adb5796b799 53808-0214 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA075491 State of Florida DOH Central Pharmacy BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 53808-0215_11787967-2085-466f-b251-c24b58f130c8 53808-0215 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA075584 State of Florida DOH Central Pharmacy BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 53808-0216_67899f20-3cd2-4af1-ac3c-c46fced8a2f3 53808-0216 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20090701 ANDA ANDA077728 State of Florida DOH Central Pharmacy CALCIUM ACETATE 667 mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 53808-0217_52511a44-c2ac-4b1a-b052-26cb891c7195 53808-0217 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090701 ANDA ANDA074505 State of Florida DOH Central Pharmacy CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 53808-0218_1339e658-4db8-40e9-a68e-c43de4857968 53808-0218 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20090701 ANDA ANDA078251 State of Florida DOH Central Pharmacy CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 53808-0219_1339e658-4db8-40e9-a68e-c43de4857968 53808-0219 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20090701 ANDA ANDA078251 State of Florida DOH Central Pharmacy CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 53808-0220_44a37407-7509-45ef-972b-b48c234f2863 53808-0220 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090701 ANDA ANDA077614 State of Florida DOH Central Pharmacy CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 53808-0221_1339e658-4db8-40e9-a68e-c43de4857968 53808-0221 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20090701 ANDA ANDA078251 State of Florida DOH Central Pharmacy CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 53808-0222_ccd16e47-b47c-48e5-8281-f679ae506ddc 53808-0222 HUMAN PRESCRIPTION DRUG Cephalexin CEPHALEXIN CAPSULE ORAL 20090701 ANDA ANDA062702 State of Florida DOH Central Pharmacy CEPHALEXIN 500 mg/1 53808-0223_a6b62110-f357-430a-b8ca-aa0dc66aa66f 53808-0223 HUMAN PRESCRIPTION DRUG Ciprofloxacin hydrochloride Ciprofloxacin hydrochloride TABLET ORAL 20090701 ANDA ANDA076089 State of Florida DOH Central Pharmacy CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 53808-0225_27718392-5a3a-4eae-819b-e0f4a2028d37 53808-0225 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20090701 ANDA ANDA078216 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0226_fdee2c6d-0343-43e4-9031-aea90341e5ef 53808-0226 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20090701 ANDA ANDA077042 State of Florida DOH Central Pharmacy CITALOPRAM 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0227_6ab2f82f-8e66-446d-83f0-73713b99667e 53808-0227 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20090701 ANDA ANDA077031 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0228_462a1a82-eaa9-4676-9569-925f18fd30d2 53808-0228 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20090701 ANDA ANDA070317 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 53808-0229_cca81cb7-cf0c-4416-b95c-897f1ed751e3 53808-0229 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 20090701 ANDA ANDA070925 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 53808-0230_462a1a82-eaa9-4676-9569-925f18fd30d2 53808-0230 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20090701 ANDA ANDA070317 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 53808-0231_d7cb62b2-8bcc-4eab-a08c-a9d78be0ed06 53808-0231 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA070976 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 53808-0233_6f87d871-e2de-4445-9ecf-d00bfeb0afec 53808-0233 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride DICYCLOMINE HYDROCHLORIDE CAPSULE ORAL 20090701 ANDA ANDA085082 State of Florida DOH Central Pharmacy DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 53808-0234_6f87d871-e2de-4445-9ecf-d00bfeb0afec 53808-0234 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride DICYCLOMINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA085223 State of Florida DOH Central Pharmacy DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 53808-0236_1dc18acf-c100-4c94-a5e5-1ba3e9218bab 53808-0236 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE PELLETS ORAL 20090701 ANDA ANDA077167 State of Florida DOH Central Pharmacy DIDANOSINE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0237_e640eb6e-424c-4960-a4a0-347bed1fba47 53808-0237 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20090701 ANDA ANDA077002 State of Florida DOH Central Pharmacy DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 53808-0238_bface779-bc4b-4c83-9760-690b25c0b6db 53808-0238 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20090701 ANDA ANDA080738 State of Florida DOH Central Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 53808-0239_92838745-01df-458d-ab9b-0305a682fdc1 53808-0239 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20090701 ANDA ANDA062396 State of Florida DOH Central Pharmacy DOXYCYCLINE HYCLATE 100 mg/1 53808-0240_62a8fff7-b70e-45a1-a284-5c6315fcbdd9 53808-0240 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20090701 ANDA ANDA062500 State of Florida DOH Central Pharmacy DOXYCYCLINE HYCLATE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 53808-0242_23f7f4ad-800c-4d98-a604-3c45b2842841 53808-0242 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20090701 ANDA ANDA075483 State of Florida DOH Central Pharmacy ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 53808-0243_23f7f4ad-800c-4d98-a604-3c45b2842841 53808-0243 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20090701 ANDA ANDA075483 State of Florida DOH Central Pharmacy ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 53808-0244_23f7f4ad-800c-4d98-a604-3c45b2842841 53808-0244 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20090701 ANDA ANDA075483 State of Florida DOH Central Pharmacy ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 53808-0245_4e2ee289-a8d8-4d02-ac27-0a2a2d0bbe22 53808-0245 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 20090701 NDA NDA020564 State of Florida DOH Central Pharmacy LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0246_4e2ee289-a8d8-4d02-ac27-0a2a2d0bbe22 53808-0246 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 20090701 NDA NDA020564 State of Florida DOH Central Pharmacy LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0247_4589f1cd-5570-48bb-a94b-499faa06d4a1 53808-0247 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20090701 ANDA ANDA089804 State of Florida DOH Central Pharmacy FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0250_3d205ce1-db62-4a8b-931b-ec5d43dceacb 53808-0250 HUMAN PRESCRIPTION DRUG Folic Acid FOLIC ACID TABLET ORAL 20090701 ANDA ANDA080600 State of Florida DOH Central Pharmacy FOLIC ACID 1 mg/1 53808-0251_359f0124-ff71-4682-99dd-3282afdee8c1 53808-0251 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20090701 ANDA ANDA074256 State of Florida DOH Central Pharmacy GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 53808-0252_782f8abe-1590-4c9a-a64c-e7dd7a73bf24 53808-0252 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20090701 NDA NDA020825 State of Florida DOH Central Pharmacy ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 53808-0253_782f8abe-1590-4c9a-a64c-e7dd7a73bf24 53808-0253 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20090701 NDA NDA020825 State of Florida DOH Central Pharmacy ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 53808-0254_782f8abe-1590-4c9a-a64c-e7dd7a73bf24 53808-0254 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20090701 NDA NDA020825 State of Florida DOH Central Pharmacy ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 53808-0255_782f8abe-1590-4c9a-a64c-e7dd7a73bf24 53808-0255 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20090701 NDA NDA020825 State of Florida DOH Central Pharmacy ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 53808-0257_f4c42007-6416-4a89-a0de-5f5fd382d511 53808-0257 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20090701 ANDA ANDA074497 State of Florida DOH Central Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 53808-0258_120da67b-a619-4a3e-a70a-b7f8bab7a80e 53808-0258 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20090701 ANDA ANDA074305 State of Florida DOH Central Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 53808-0259_120da67b-a619-4a3e-a70a-b7f8bab7a80e 53808-0259 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20090701 ANDA ANDA074305 State of Florida DOH Central Pharmacy GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 53808-0260_f4c42007-6416-4a89-a0de-5f5fd382d511 53808-0260 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20090701 ANDA ANDA074497 State of Florida DOH Central Pharmacy GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 53808-0261_95cbdf47-932d-40d3-bc1d-e055170711d6 53808-0261 HUMAN PRESCRIPTION DRUG Gris-PEG GRISEOFULVIN TABLET, FILM COATED ORAL 20090701 NDA NDA050475 State of Florida DOH Central Pharmacy GRISEOFULVIN 250 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 53808-0263_ff1989ff-b72f-4071-b121-ed099cef0a9f 53808-0263 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20090701 ANDA ANDA071209 State of Florida DOH Central Pharmacy HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 53808-0264_3cf84e3a-2a50-4d72-9461-ffd9c78bd244 53808-0264 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20090701 ANDA ANDA070278 State of Florida DOH Central Pharmacy HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 53808-0265_4b0829da-c42f-4850-ac45-ac363e773ff7 53808-0265 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20090701 ANDA ANDA078164 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 53808-0266_7c9d486e-b2ef-4dc7-97cf-1a545471f73f 53808-0266 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20090701 ANDA ANDA084878 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 53808-0271_b4a23505-70ad-4e79-9923-a37ce160b072 53808-0271 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20090701 ANDA ANDA078558 State of Florida DOH Central Pharmacy IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53808-0272_42aee221-dc31-493c-b420-18cdb1546968 53808-0272 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090701 ANDA ANDA071334 State of Florida DOH Central Pharmacy IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53808-0273_42aee221-dc31-493c-b420-18cdb1546968 53808-0273 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090701 ANDA ANDA071335 State of Florida DOH Central Pharmacy IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53808-0274_be372192-7929-425c-9c3a-396b75f6882f 53808-0274 HUMAN PRESCRIPTION DRUG Isosorbide ISOSORBIDE DINITRATE TABLET ORAL 20090701 ANDA ANDA086066 State of Florida DOH Central Pharmacy ISOSORBIDE DINITRATE 10 mg/1 53808-0275_be372192-7929-425c-9c3a-396b75f6882f 53808-0275 HUMAN PRESCRIPTION DRUG Isosorbide ISOSORBIDE DINITRATE TABLET ORAL 20090701 ANDA ANDA086066 State of Florida DOH Central Pharmacy ISOSORBIDE DINITRATE 20 mg/1 53808-0277_7eefbe68-0324-4b28-b777-3922e62c7471 53808-0277 HUMAN PRESCRIPTION DRUG K-TAB POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 NDA NDA018279 State of Florida DOH Central Pharmacy POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 53808-0278_6a46fb5b-6243-4901-8152-dc651643b684 53808-0278 HUMAN PRESCRIPTION DRUG Klor-Con Extended-release Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20090701 NDA NDA019123 State of Florida DOH Central Pharmacy POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 53808-0279_feb3b39a-cb33-4b75-8ed9-a991ee25d31e 53808-0279 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20090701 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 53808-0280_feb3b39a-cb33-4b75-8ed9-a991ee25d31e 53808-0280 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20090701 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 53808-0281_cece4944-71c2-4ded-a002-3475b1cae6a2 53808-0281 HUMAN PRESCRIPTION DRUG LEXIVA fosamprenavir calcium TABLET, FILM COATED ORAL 20090701 NDA NDA021548 State of Florida DOH Central Pharmacy FOSAMPRENAVIR CALCIUM 700 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA] 53808-0302_377ae7e3-f630-4ebb-b85c-312b614c8631 53808-0302 HUMAN PRESCRIPTION DRUG SULINDAC sulindac TABLET ORAL 20090701 ANDA ANDA072051 State of Florida DOH Central Pharmacy SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53808-0303_3f0ef949-f3ea-4ff8-877a-c412ae2e175e 53808-0303 HUMAN PRESCRIPTION DRUG Sulindac SULINDAC TABLET ORAL 20090701 ANDA ANDA073262 State of Florida DOH Central Pharmacy SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53808-0305_f119023a-c0b0-4201-ad2a-3ac5ef3e2fbc 53808-0305 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075614 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 53808-0306_344b0ac9-7bea-4167-8b70-3a000fb50823 53808-0306 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075498 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 53808-0307_9e1fb9de-7a5e-4878-af41-2efe32d8f9ad 53808-0307 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075317 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 53808-0308_344b0ac9-7bea-4167-8b70-3a000fb50823 53808-0308 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075498 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 53808-0309_9e1fb9de-7a5e-4878-af41-2efe32d8f9ad 53808-0309 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075317 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 53808-0310_2af82929-450b-40bc-82ba-f365b94a5521 53808-0310 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20090701 ANDA ANDA076228 State of Florida DOH Central Pharmacy RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 53808-0311_9e1fb9de-7a5e-4878-af41-2efe32d8f9ad 53808-0311 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075317 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 53808-0312_32eaf085-4c88-4aec-b763-9cfcc966ff5f 53808-0312 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate TERBUTALINE SULFATE TABLET ORAL 20090701 ANDA ANDA077152 State of Florida DOH Central Pharmacy TERBUTALINE SULFATE 2.5 mg/1 53808-0315_adfc71f3-28e7-4f69-95bd-2f87e3c0243d 53808-0315 HUMAN PRESCRIPTION DRUG Theophylline (Anhydrous) Theophylline TABLET, EXTENDED RELEASE ORAL 20090701 ANDA ANDA089808 State of Florida DOH Central Pharmacy THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 53808-0316_adfc71f3-28e7-4f69-95bd-2f87e3c0243d 53808-0316 HUMAN PRESCRIPTION DRUG Theophylline (Anhydrous) Theophylline TABLET, EXTENDED RELEASE ORAL 20090701 ANDA ANDA089763 State of Florida DOH Central Pharmacy THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 53808-0324_ec8d1d34-d828-493d-b145-da4f4e2725ea 53808-0324 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 NDA NDA019152 State of Florida DOH Central Pharmacy VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 53808-0329_a35648a5-edad-466e-97cf-fc1ce7993bce 53808-0329 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 ANDA ANDA073568 State of Florida DOH Central Pharmacy VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 53808-0334_6505df44-aafe-42d9-ac5d-a517238f55ee 53808-0334 HUMAN PRESCRIPTION DRUG Warfarin Sodium WARFARIN SODIUM TABLET ORAL 20090701 ANDA ANDA040301 State of Florida DOH Central Pharmacy WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 53808-0335_6505df44-aafe-42d9-ac5d-a517238f55ee 53808-0335 HUMAN PRESCRIPTION DRUG Warfarin Sodium WARFARIN SODIUM TABLET ORAL 20090701 ANDA ANDA040301 State of Florida DOH Central Pharmacy WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 53808-0338_563b3f57-28df-47cb-b929-86783f5414e1 53808-0338 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20090701 ANDA ANDA040750 State of Florida DOH Central Pharmacy SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 53808-0340_3708f86b-3fcb-49a2-9d6e-92a7b123ab04 53808-0340 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20090701 ANDA ANDA077262 State of Florida DOH Central Pharmacy AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53808-0341_9a69d84c-47c1-4d64-a51b-4f726d472cf8 53808-0341 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED ORAL 20090701 ANDA ANDA065101 State of Florida DOH Central Pharmacy AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 53808-0344_81b9fca7-f47d-4293-87ae-856c4b1c5f96 53808-0344 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20090701 ANDA ANDA076900 State of Florida DOH Central Pharmacy ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0345_b9f26cb9-7155-4c81-9b2e-7f1d72bddc46 53808-0345 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20090701 ANDA ANDA077877 State of Florida DOH Central Pharmacy ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0346_b9f26cb9-7155-4c81-9b2e-7f1d72bddc46 53808-0346 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20090701 ANDA ANDA077877 State of Florida DOH Central Pharmacy ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0347_52511a44-c2ac-4b1a-b052-26cb891c7195 53808-0347 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090701 ANDA ANDA074505 State of Florida DOH Central Pharmacy CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 53808-0347_b5efba99-807d-4778-b769-e95c960a9e86 53808-0347 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA075491 State of Florida DOH Central Pharmacy BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 53808-0348_e4a7f215-ee57-4a42-9cc8-8656a08f45ea 53808-0348 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090701 ANDA ANDA074505 State of Florida DOH Central Pharmacy CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 53808-0349_3a986ef3-1be4-4686-9679-acef5ca5ca21 53808-0349 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA076794 State of Florida DOH Central Pharmacy CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 53808-0350_27718392-5a3a-4eae-819b-e0f4a2028d37 53808-0350 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20090701 ANDA ANDA078216 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0351_f086cca5-5d13-4a7f-9713-c6d4fcf43665 53808-0351 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide CITALOPRAM HYDROBROMIDE TABLET, FILM COATED ORAL 20090701 ANDA ANDA077046 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0352_d7cb62b2-8bcc-4eab-a08c-a9d78be0ed06 53808-0352 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA070904 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 53808-0353_1dc18acf-c100-4c94-a5e5-1ba3e9218bab 53808-0353 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE PELLETS ORAL 20090701 ANDA ANDA077167 State of Florida DOH Central Pharmacy DIDANOSINE 400 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0354_54d59552-7316-4ea7-b0b3-4e9e761ea4cd 53808-0354 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20090701 ANDA ANDA007628 State of Florida DOH Central Pharmacy DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 53808-0355_e640eb6e-424c-4960-a4a0-347bed1fba47 53808-0355 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20090701 ANDA ANDA077002 State of Florida DOH Central Pharmacy DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 53808-0356_21f86570-ae06-4196-a09d-15bb669b9224 53808-0356 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20090701 ANDA ANDA090062 State of Florida DOH Central Pharmacy DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 53808-0357_02550fd6-1cc7-438a-8f3d-d2c4b2da8000 53808-0357 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20090701 ANDA ANDA078790 State of Florida DOH Central Pharmacy DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 53808-0358_02550fd6-1cc7-438a-8f3d-d2c4b2da8000 53808-0358 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20090701 ANDA ANDA078790 State of Florida DOH Central Pharmacy DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 53808-0361_7a5592af-57c2-48b1-b7e4-5c15ed9cd14f 53808-0361 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20090701 ANDA ANDA075536 State of Florida DOH Central Pharmacy DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 53808-0362_7a5592af-57c2-48b1-b7e4-5c15ed9cd14f 53808-0362 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20090701 ANDA ANDA075536 State of Florida DOH Central Pharmacy DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 53808-0364_4f9270e1-42ae-48f4-93dc-70dc5dd56eef 53808-0364 HUMAN PRESCRIPTION DRUG Doxazosin DOXAZOSIN MESYLATE TABLET ORAL 20090701 ANDA ANDA075580 State of Florida DOH Central Pharmacy DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 53808-0366_bf71addd-a989-4420-9741-4e7a404725e7 53808-0366 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075049 State of Florida DOH Central Pharmacy FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0367_148f9cb8-e3b7-41e8-ae24-c1468380fc12 53808-0367 HUMAN PRESCRIPTION DRUG Furosemide FUROSEMIDE TABLET ORAL 20090701 NDA NDA018487 State of Florida DOH Central Pharmacy FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 53808-0368_2c7f8247-ab92-4487-90e5-458e72b791ce 53808-0368 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20090701 ANDA ANDA075034 State of Florida DOH Central Pharmacy GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 53808-0369_d50f8011-19de-4fd5-8d7b-61d8618c77d7 53808-0369 HUMAN PRESCRIPTION DRUG Glipizide GLIPIZIDE TABLET ORAL 20090701 ANDA ANDA074223 State of Florida DOH Central Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 53808-0372_3cf84e3a-2a50-4d72-9461-ffd9c78bd244 53808-0372 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20090701 ANDA ANDA070278 State of Florida DOH Central Pharmacy HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] 53808-0373_4a569fe7-e80a-4e04-8b9c-52eb65ed4b96 53808-0373 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate HYDROXYZINE PAMOATE CAPSULE ORAL 20090701 ANDA ANDA088496 State of Florida DOH Central Pharmacy HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 53808-0374_4a569fe7-e80a-4e04-8b9c-52eb65ed4b96 53808-0374 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate HYDROXYZINE PAMOATE CAPSULE ORAL 20090701 ANDA ANDA088487 State of Florida DOH Central Pharmacy HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 53808-0375_6a46fb5b-6243-4901-8152-dc651643b684 53808-0375 HUMAN PRESCRIPTION DRUG Klor-Con Extended-release Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20090701 NDA NDA019123 State of Florida DOH Central Pharmacy POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 53808-0376_30b8361b-39f0-4763-a149-9b2eb7d169f1 53808-0376 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20090701 ANDA ANDA076919 State of Florida DOH Central Pharmacy LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 53808-0377_80210249-70fb-4d75-be2b-8c490f5d26fe 53808-0377 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090701 ANDA ANDA078234 State of Florida DOH Central Pharmacy LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 53808-0379_133790e1-93d7-46cc-9385-fbf7ad7ded38 53808-0379 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20090701 ANDA ANDA075752 State of Florida DOH Central Pharmacy LISINOPRIL 5 mg/1 53808-0380_00973f5a-1447-4002-a86a-e2b61fad3678 53808-0380 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA087128 State of Florida DOH Central Pharmacy MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 53808-0381_45abd94e-142e-4da8-ad7b-566a18395935 53808-0381 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20090701 ANDA ANDA078170 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 53808-0382_f59d2f6d-b2ff-418e-92fc-e00ccd7d63ff 53808-0382 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20090701 ANDA ANDA076704 State of Florida DOH Central Pharmacy METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0384_1cc2185f-3508-416f-adef-71235f629434 53808-0384 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20090701 ANDA ANDA076122 State of Florida DOH Central Pharmacy MIRTAZAPINE 15 mg/1 53808-0386_443d6c91-7f02-4950-940f-c5192ed6f519 53808-0386 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20090701 ANDA ANDA078250 State of Florida DOH Central Pharmacy NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53808-0387_06bf9e41-9ba5-477f-9126-fa1aa23eee32 53808-0387 HUMAN PRESCRIPTION DRUG Nifedipine NIFEDIPINE TABLET, EXTENDED RELEASE ORAL 20090701 ANDA ANDA077899 State of Florida DOH Central Pharmacy NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53808-0388_668ca968-ba6e-4477-9fa1-76b42377c8dc 53808-0388 HUMAN PRESCRIPTION DRUG Nifediac CC Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 ANDA ANDA075269 State of Florida DOH Central Pharmacy NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53808-0389_06bf9e41-9ba5-477f-9126-fa1aa23eee32 53808-0389 HUMAN PRESCRIPTION DRUG Nifedipine NIFEDIPINE TABLET, EXTENDED RELEASE ORAL 20090701 ANDA ANDA077899 State of Florida DOH Central Pharmacy NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53808-0393_2f9e9ab0-e535-46e9-9f50-20bb433e38f9 53808-0393 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20090701 ANDA ANDA078902 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0394_2f9e9ab0-e535-46e9-9f50-20bb433e38f9 53808-0394 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20090701 ANDA ANDA078902 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0395_533b9303-6097-4eee-a802-d7623461b82a 53808-0395 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, SUGAR COATED ORAL 20090701 ANDA ANDA040226 State of Florida DOH Central Pharmacy PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0396_6171c106-7c2f-49c0-b123-91d7019ce453 53808-0396 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE ORAL 20090701 ANDA ANDA076368 State of Florida DOH Central Pharmacy POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 53808-0397_6171c106-7c2f-49c0-b123-91d7019ce453 53808-0397 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE ORAL 20090701 ANDA ANDA076368 State of Florida DOH Central Pharmacy POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 53808-0398_9db1257e-0491-4c8d-85d6-37fa1f425cbd 53808-0398 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20090701 ANDA ANDA077987 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0399_9186d7c5-980c-49ad-8185-e9e13df26df4 53808-0399 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20090701 ANDA ANDA083677 State of Florida DOH Central Pharmacy PREDNISONE 20 mg/1 53808-0400_909faecb-fb9e-48a7-a66b-0ae151d1e9a0 53808-0400 HUMAN PRESCRIPTION DRUG Glipizide GLIPIZIDE TABLET ORAL 20090701 ANDA ANDA075795 State of Florida DOH Central Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 53808-0401_9a06be01-be79-4aec-869b-b76a2ce44f8a 53808-0401 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, EXTENDED RELEASE ORAL 20090701 ANDA ANDA076467 State of Florida DOH Central Pharmacy GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 53808-0408_5edec495-4de9-4313-a841-c22309acadfe 53808-0408 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 20090701 NDA NDA020329 State of Florida DOH Central Pharmacy GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 53808-0409_5edec495-4de9-4313-a841-c22309acadfe 53808-0409 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 20090701 NDA NDA020329 State of Florida DOH Central Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 53808-0411_15601703-7442-48f3-89f4-44fef66b7514 53808-0411 HUMAN PRESCRIPTION DRUG Xeloda capecitabine TABLET, FILM COATED ORAL 20090701 NDA NDA020896 State of Florida DOH Central Pharmacy CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 53808-0414_ff1989ff-b72f-4071-b121-ed099cef0a9f 53808-0414 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20090701 ANDA ANDA071208 State of Florida DOH Central Pharmacy HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] 53808-0419_6a12a175-287e-48ae-bd9b-b267e7e28567 53808-0419 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20090701 ANDA ANDA075907 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 53808-0422_6a12a175-287e-48ae-bd9b-b267e7e28567 53808-0422 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide TABLET ORAL 20090701 ANDA ANDA075907 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 53808-0426_7896d94e-463d-41ff-8ac0-0680c8c857df 53808-0426 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate HYDROXYZINE PAMOATE CAPSULE ORAL 20090701 ANDA ANDA040156 State of Florida DOH Central Pharmacy HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 53808-0429_7896d94e-463d-41ff-8ac0-0680c8c857df 53808-0429 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate HYDROXYZINE PAMOATE CAPSULE ORAL 20090701 ANDA ANDA040156 State of Florida DOH Central Pharmacy HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 53808-0431_4a569fe7-e80a-4e04-8b9c-52eb65ed4b96 53808-0431 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate HYDROXYZINE PAMOATE CAPSULE ORAL 20090701 ANDA ANDA088488 State of Florida DOH Central Pharmacy HYDROXYZINE PAMOATE 100 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 53808-0435_b4a23505-70ad-4e79-9923-a37ce160b072 53808-0435 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20090701 ANDA ANDA078558 State of Florida DOH Central Pharmacy IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53808-0436_42aee221-dc31-493c-b420-18cdb1546968 53808-0436 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090701 ANDA ANDA071335 State of Florida DOH Central Pharmacy IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53808-0446_7301eec3-0d3c-4d44-b517-e22eb4791f13 53808-0446 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090701 NDA NDA021210 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 53808-0447_7301eec3-0d3c-4d44-b517-e22eb4791f13 53808-0447 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090701 NDA NDA021210 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 53808-0449_7301eec3-0d3c-4d44-b517-e22eb4791f13 53808-0449 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090701 NDA NDA021210 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 53808-0451_be846696-b798-4124-a1ae-9bbe4c8588ff 53808-0451 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20090701 ANDA ANDA077321 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 53808-0452_cbd971fd-9be2-4407-be07-63072d218b76 53808-0452 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20090701 ANDA ANDA078402 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 53808-0453_be846696-b798-4124-a1ae-9bbe4c8588ff 53808-0453 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20090701 ANDA ANDA077321 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 53808-0457_f9604c52-0f89-43dc-8be9-e478db8f029e 53808-0457 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20090701 ANDA ANDA076301 State of Florida DOH Central Pharmacy LORATADINE 10 mg/1 53808-0459_34fcbbab-fafb-422c-9389-141a52c8b045 53808-0459 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA077095 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 53808-0474_d89858c2-db7b-4496-b730-98d4c5864aa5 53808-0474 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20090701 ANDA ANDA070027 State of Florida DOH Central Pharmacy METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 53808-0478_cc4f0754-489c-41b9-b871-1c9a79779503 53808-0478 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20090701 ANDA ANDA071973 State of Florida DOH Central Pharmacy PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0482_3d0fdbe3-37f0-4f8c-a132-76c2fd155c55 53808-0482 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090701 ANDA ANDA077666 State of Florida DOH Central Pharmacy MIRTAZAPINE 15 mg/1 53808-0483_3d0fdbe3-37f0-4f8c-a132-76c2fd155c55 53808-0483 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090701 ANDA ANDA077666 State of Florida DOH Central Pharmacy MIRTAZAPINE 30 mg/1 53808-0484_3d0fdbe3-37f0-4f8c-a132-76c2fd155c55 53808-0484 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090701 ANDA ANDA077666 State of Florida DOH Central Pharmacy MIRTAZAPINE 45 mg/1 53808-0496_cb95c93f-4e5e-4ae7-a755-b24d2d6e6474 53808-0496 HUMAN PRESCRIPTION DRUG nifedipine NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 NDA NDA019684 State of Florida DOH Central Pharmacy NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53808-0500_eaac3a82-2f22-47b4-b3a2-41aab8d9c4af 53808-0500 HUMAN PRESCRIPTION DRUG Nifediac CC Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 ANDA ANDA076070 State of Florida DOH Central Pharmacy NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53808-0516_23daa058-b3fc-4518-89e4-7da98cd2f0ec 53808-0516 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 ANDA ANDA075191 State of Florida DOH Central Pharmacy PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 53808-0536_4bb744b3-53ca-41c6-90ab-fe35cc1bc8bc 53808-0536 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20090701 ANDA ANDA076341 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0538_4bb744b3-53ca-41c6-90ab-fe35cc1bc8bc 53808-0538 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20090701 ANDA ANDA076341 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0540_9186d7c5-980c-49ad-8185-e9e13df26df4 53808-0540 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20090701 ANDA ANDA088832 State of Florida DOH Central Pharmacy PREDNISONE 5 mg/1 53808-0542_db44ab07-40f8-4c1d-ab88-cfe4b0476962 53808-0542 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20090701 ANDA ANDA040256 State of Florida DOH Central Pharmacy PREDNISONE 10 mg/1 53808-0543_db44ab07-40f8-4c1d-ab88-cfe4b0476962 53808-0543 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20090701 ANDA ANDA040392 State of Florida DOH Central Pharmacy PREDNISONE 20 mg/1 53808-0545_b5cb6a82-f1ae-422a-909c-b75e214bbc40 53808-0545 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA040596 State of Florida DOH Central Pharmacy PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0546_9c6f2837-3027-4a9e-9430-876dd4ccecc1 53808-0546 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA040712 State of Florida DOH Central Pharmacy PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0547_951caa1a-b448-4864-abdc-4c47f87ef3cf 53808-0547 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20090701 ANDA ANDA078955 State of Florida DOH Central Pharmacy PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0551_951caa1a-b448-4864-abdc-4c47f87ef3cf 53808-0551 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20090701 ANDA ANDA078955 State of Florida DOH Central Pharmacy PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0559_93662de7-bfe4-4237-aa23-7370a2515cb1 53808-0559 HUMAN PRESCRIPTION DRUG Rifampin RIFAMPIN CAPSULE, COATED ORAL 20090701 ANDA ANDA065028 State of Florida DOH Central Pharmacy RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 53808-0560_db44ab07-40f8-4c1d-ab88-cfe4b0476962 53808-0560 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20090701 ANDA ANDA040256 State of Florida DOH Central Pharmacy PREDNISONE 5 mg/1 53808-0574_df05a7ce-0e25-4c7c-a69d-1e1b9e13de61 53808-0574 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 State of Florida DOH Central Pharmacy RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 53808-0577_29dcedcd-efba-436a-8542-99faff58875f 53808-0577 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20090701 NDA NDA021688 State of Florida DOH Central Pharmacy CINACALCET HYDROCHLORIDE 30 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] 53808-0578_29dcedcd-efba-436a-8542-99faff58875f 53808-0578 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20090701 NDA NDA021688 State of Florida DOH Central Pharmacy CINACALCET HYDROCHLORIDE 60 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] 53808-0579_f7280544-b20f-450a-a4f3-24c288ed2012 53808-0579 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA077397 State of Florida DOH Central Pharmacy SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0581_f7280544-b20f-450a-a4f3-24c288ed2012 53808-0581 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA077397 State of Florida DOH Central Pharmacy SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0582_d520f657-e5b4-4910-add5-978daa79b0d5 53808-0582 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 20090701 NDA NDA019839 State of Florida DOH Central Pharmacy SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0586_56627a5a-696b-41cd-9d0c-8d34b074ba6a 53808-0586 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA077670 State of Florida DOH Central Pharmacy SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0587_f7280544-b20f-450a-a4f3-24c288ed2012 53808-0587 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA077397 State of Florida DOH Central Pharmacy SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0592_563b3f57-28df-47cb-b929-86783f5414e1 53808-0592 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20090701 ANDA ANDA040750 State of Florida DOH Central Pharmacy SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 53808-0593_ecd35838-b551-4cc1-8cb2-2dc3335c61d4 53808-0593 HUMAN PRESCRIPTION DRUG Sucralfate SUCRALFATE TABLET ORAL 20090701 NDA NDA018333 State of Florida DOH Central Pharmacy SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 53808-0594_995c744e-3132-4384-9d05-8976bfd1bc7d 53808-0594 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20090701 ANDA ANDA079069 State of Florida DOH Central Pharmacy STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0595_8a5e45f3-462d-4f86-b06b-4df7ca2da01e 53808-0595 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20090701 ANDA ANDA078957 State of Florida DOH Central Pharmacy STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0600_4589f1cd-5570-48bb-a94b-499faa06d4a1 53808-0600 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20090701 ANDA ANDA089804 State of Florida DOH Central Pharmacy FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0601_2f9e9ab0-e535-46e9-9f50-20bb433e38f9 53808-0601 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20090701 ANDA ANDA078902 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0602_b49a1ada-2942-400e-be4a-18c06cbecad2 53808-0602 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20130101 ANDA ANDA090515 State of Florida DOH Central Pharmacy LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 53808-0603_1339e658-4db8-40e9-a68e-c43de4857968 53808-0603 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20090701 ANDA ANDA078251 State of Florida DOH Central Pharmacy CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 53808-0604_0ea2345f-d110-4f6a-af82-cf862207127c 53808-0604 HUMAN PRESCRIPTION DRUG Allopurinol ALLOPURINOL TABLET ORAL 20090701 NDA NDA018832 State of Florida DOH Central Pharmacy ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 53808-0605_feb3b39a-cb33-4b75-8ed9-a991ee25d31e 53808-0605 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20090701 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 53808-0606_feb3b39a-cb33-4b75-8ed9-a991ee25d31e 53808-0606 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20090701 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 53808-0607_feb3b39a-cb33-4b75-8ed9-a991ee25d31e 53808-0607 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20090701 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 53808-0608_feb3b39a-cb33-4b75-8ed9-a991ee25d31e 53808-0608 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20090701 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 53808-0609_d88b8407-6321-44b4-bf1e-1f620e643a80 53808-0609 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 20130101 ANDA ANDA075211 State of Florida DOH Central Pharmacy ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 53808-0611_60f294ff-ca82-4023-b929-dac46aca6867 53808-0611 HUMAN PRESCRIPTION DRUG Dicyclomine DICYCLOMINE HYDROCHLORIDE CAPSULE ORAL 20090701 ANDA ANDA040204 State of Florida DOH Central Pharmacy DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 53808-0612_c41bbdff-b9a6-4235-acf7-680e95dd57aa 53808-0612 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20090701 ANDA ANDA074984 State of Florida DOH Central Pharmacy DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 53808-0613_93d2b84b-0609-4350-88c9-464b7add33f6 53808-0613 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20090701 ANDA ANDA077336 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 53808-0614_b1c52027-d48b-4960-beea-9ec1721eccae 53808-0614 HUMAN PRESCRIPTION DRUG Megestrol Acetate MEGESTROL ACETATE TABLET ORAL 20090701 ANDA ANDA074458 State of Florida DOH Central Pharmacy MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 53808-0615_88ea22b4-1004-478a-b914-09dd77dde766 53808-0615 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20090701 ANDA ANDA075927 State of Florida DOH Central Pharmacy NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53808-0616_34db910e-8a16-4cee-a04e-27a363f0c269 53808-0616 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20130101 ANDA ANDA090540 State of Florida DOH Central Pharmacy CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 53808-0617_dd158c6f-db49-4875-a5f2-853947200bf1 53808-0617 HUMAN PRESCRIPTION DRUG Lisinopril LISINOPRIL TABLET ORAL 20090701 ANDA ANDA077622 State of Florida DOH Central Pharmacy LISINOPRIL 20 mg/1 53808-0618_029f6aeb-9a10-4aa1-9c87-bec59bd75bfe 53808-0618 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 20090701 ANDA ANDA075079 State of Florida DOH Central Pharmacy OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 53808-0619_08665e9d-75fe-420f-85a0-f9f89d889fba 53808-0619 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA040788 State of Florida DOH Central Pharmacy HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 53808-0621_f270b06b-e60d-41e3-88bc-9599737f8dba 53808-0621 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130101 ANDA ANDA077127 State of Florida DOH Central Pharmacy NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53808-0622_8b88451a-13e3-4a26-848d-b6209aa21ddb 53808-0622 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20130101 ANDA ANDA062791 State of Florida DOH Central Pharmacy CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 53808-0623_a995488f-2f37-47fa-9315-d75d407160db 53808-0623 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20130101 ANDA ANDA071250 State of Florida DOH Central Pharmacy METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 53808-0624_76437cab-3ca6-4e54-9c58-803f50404969 53808-0624 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20130101 ANDA ANDA076288 State of Florida DOH Central Pharmacy RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 53808-0625_59ddd062-699a-4baf-942c-0b660cb1b15e 53808-0625 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20130101 ANDA ANDA074550 State of Florida DOH Central Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 53808-0626_bd1688e6-8f0a-4238-bf1a-ecd770bb6496 53808-0626 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20130101 ANDA ANDA089367 State of Florida DOH Central Pharmacy ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 53808-0627_61e9324f-3ef3-45d7-9735-a89a03aeec42 53808-0627 HUMAN PRESCRIPTION DRUG Abacavir Sulfate abacavir sulfate TABLET, FILM COATED ORAL 20130101 ANDA ANDA091294 State of Florida DOH Central Pharmacy ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0628_77fcfab4-3e34-45c9-9048-a3b9c1e9de6b 53808-0628 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20130101 ANDA ANDA075382 State of Florida DOH Central Pharmacy ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 53808-0629_a93001d2-6248-4c2b-b84a-a7458c232f0c 53808-0629 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA040209 State of Florida DOH Central Pharmacy TRIFLUOPERAZINE HYDROCHLORIDE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0631_b252f4a8-1e2d-48b0-9296-dc9681acdcf7 53808-0631 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20130101 ANDA ANDA070278 State of Florida DOH Central Pharmacy HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] 53808-0632_754bd072-a82f-420e-92ea-835e86aa20bf 53808-0632 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA040812 State of Florida DOH Central Pharmacy HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 53808-0633_19e8bb23-2263-46dc-8d64-895aecd5fac0 53808-0633 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 20130101 ANDA ANDA040254 State of Florida DOH Central Pharmacy TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 53808-0634_19e8bb23-2263-46dc-8d64-895aecd5fac0 53808-0634 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 20130101 ANDA ANDA040254 State of Florida DOH Central Pharmacy TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 53808-0635_2d482302-2476-4395-bcc2-53404748c889 53808-0635 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA077655 State of Florida DOH Central Pharmacy VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 53808-0636_d17582ef-7f72-4b17-b48b-cd4bdf9c0df7 53808-0636 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20130901 ANDA ANDA078993 State of Florida DOH Central Pharmacy LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 53808-0639_fe96ad53-5780-4544-89c5-05f18b25b4c7 53808-0639 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA078643 State of Florida DOH Central Pharmacy CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 53808-0643_16c097f9-0493-4a50-9486-6f993fab4937 53808-0643 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20090701 ANDA ANDA076795 State of Florida DOH Central Pharmacy LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 53808-0644_70202a73-7bee-4596-96f8-96154d758841 53808-0644 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride TABLET ORAL 20090701 ANDA ANDA040319 State of Florida DOH Central Pharmacy DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 53808-0646_9607ed40-8d81-4476-ad94-a3d9f5a4997a 53808-0646 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20130101 ANDA ANDA076921 State of Florida DOH Central Pharmacy MIRTAZAPINE 15 mg/1 53808-0647_fdee2c6d-0343-43e4-9031-aea90341e5ef 53808-0647 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20090701 ANDA ANDA077042 State of Florida DOH Central Pharmacy CITALOPRAM 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0648_266007f1-3e2f-4142-92c2-cdb20fb73f99 53808-0648 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20090701 ANDA ANDA075479 State of Florida DOH Central Pharmacy ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 53808-0650_7e55b122-534a-4fcc-9b47-f7263d25b363 53808-0650 HUMAN PRESCRIPTION DRUG ISENTRESS raltegravir TABLET, FILM COATED ORAL 20090701 NDA NDA022145 State of Florida DOH Central Pharmacy RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] 53808-0652_d11a28f5-d648-44c5-955c-02259fa53884 53808-0652 HUMAN PRESCRIPTION DRUG Phenytoin Sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20090701 ANDA ANDA040298 State of Florida DOH Central Pharmacy PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 53808-0653_24efe210-73f3-446c-a8d3-88baa1508702 53808-0653 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20090701 ANDA ANDA076418 State of Florida DOH Central Pharmacy AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53808-0654_ff1989ff-b72f-4071-b121-ed099cef0a9f 53808-0654 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20090701 ANDA ANDA071207 State of Florida DOH Central Pharmacy HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] 53808-0655_2f9e9ab0-e535-46e9-9f50-20bb433e38f9 53808-0655 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20090701 ANDA ANDA078902 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0656_66893c23-b206-4107-ad2b-1af596b4c5c5 53808-0656 HUMAN PRESCRIPTION DRUG ZERIT stavudine CAPSULE, GELATIN COATED ORAL 20090701 NDA NDA020412 State of Florida DOH Central Pharmacy STAVUDINE 20 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0657_66893c23-b206-4107-ad2b-1af596b4c5c5 53808-0657 HUMAN PRESCRIPTION DRUG ZERIT stavudine CAPSULE, GELATIN COATED ORAL 20090701 NDA NDA020412 State of Florida DOH Central Pharmacy STAVUDINE 30 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0658_66c085b7-3ec3-43b4-a095-e04cf8d7a76a 53808-0658 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20090701 ANDA ANDA078512 State of Florida DOH Central Pharmacy ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0659_6fe65de6-b8ac-4d1a-b9b0-834bac4a6aac 53808-0659 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate METOPROLOL TARTRATE TABLET ORAL 20090701 ANDA ANDA076670 State of Florida DOH Central Pharmacy METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0660_66c085b7-3ec3-43b4-a095-e04cf8d7a76a 53808-0660 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20090701 ANDA ANDA078512 State of Florida DOH Central Pharmacy ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0661_b34e05d5-b64b-42d0-a121-f5e21dfc3c1b 53808-0661 HUMAN PRESCRIPTION DRUG CRIXIVAN indinavir sulfate CAPSULE ORAL 20090701 NDA NDA020685 State of Florida DOH Central Pharmacy INDINAVIR SULFATE 400 mg/1 53808-0662_6a12a175-287e-48ae-bd9b-b267e7e28567 53808-0662 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide TABLET ORAL 20090701 ANDA ANDA075907 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 53808-0663_266007f1-3e2f-4142-92c2-cdb20fb73f99 53808-0663 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20090701 ANDA ANDA075479 State of Florida DOH Central Pharmacy ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 53808-0664_51a71da6-5750-47fa-bf22-8f227ff4288b 53808-0664 HUMAN PRESCRIPTION DRUG Perphenazine PERPHENAZINE TABLET, FILM COATED ORAL 20090701 ANDA ANDA089686 State of Florida DOH Central Pharmacy PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0665_51a71da6-5750-47fa-bf22-8f227ff4288b 53808-0665 HUMAN PRESCRIPTION DRUG Perphenazine PERPHENAZINE TABLET, FILM COATED ORAL 20090701 ANDA ANDA089684 State of Florida DOH Central Pharmacy PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0668_feb3b39a-cb33-4b75-8ed9-a991ee25d31e 53808-0668 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20090701 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 53808-0671_4d0ada65-a960-4229-8e17-3f33e4b9e8db 53808-0671 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20130101 ANDA ANDA078010 State of Florida DOH Central Pharmacy FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 53808-0672_293699e1-d0c8-4d54-b360-e76b26b7da68 53808-0672 HUMAN PRESCRIPTION DRUG PREZISTA darunavir ethanolate TABLET, FILM COATED ORAL 20090701 NDA NDA021976 State of Florida DOH Central Pharmacy DARUNAVIR ETHANOLATE 400 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] 53808-0673_206f82e1-b242-4862-81a1-daec96ce745e 53808-0673 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20090701 ANDA ANDA077836 State of Florida DOH Central Pharmacy GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 53808-0674_e981c067-b7f7-440b-a4d3-1cd79038af4a 53808-0674 HUMAN PRESCRIPTION DRUG Invirase saquinavir mesylate TABLET, FILM COATED ORAL 20090701 NDA NDA021785 State of Florida DOH Central Pharmacy SAQUINAVIR MESYLATE 500 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 53808-0677_1563f468-2a2d-4f15-a04c-9a37c3c24996 53808-0677 HUMAN OTC DRUG DocQLace docusate sodium CAPSULE ORAL 20130101 OTC MONOGRAPH NOT FINAL part334 State of Florida DOH Central Pharmacy DOCUSATE SODIUM 100 mg/1 53808-0678_7b9ff69e-983f-4746-b250-9276642e2846 53808-0678 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20130101 ANDA ANDA074550 State of Florida DOH Central Pharmacy GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 53808-0679_e3450a89-d439-4835-a9ca-fee52563bdcf 53808-0679 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20130101 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 53808-0680_e15b05c5-0ba5-4f29-985a-63d8ec3f97af 53808-0680 HUMAN PRESCRIPTION DRUG Nevirapine nevirapine TABLET ORAL 20130101 ANDA ANDA202523 State of Florida DOH Central Pharmacy NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 53808-0681_dd72b287-cb96-414f-9e0d-a9313d1cbf73 53808-0681 HUMAN PRESCRIPTION DRUG Divalproex Sodium Delayed-Release Divalproex Sodium TABLET, FILM COATED ORAL 20130101 ANDA ANDA090210 State of Florida DOH Central Pharmacy DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 53808-0682_e18fe82b-fe72-4952-816b-0900e62361fd 53808-0682 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride Hemihydrate TABLET, FILM COATED ORAL 20130101 ANDA ANDA077584 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0683_9b9bc863-13d3-4a5c-83ac-5dca8b28d37b 53808-0683 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20130101 ANDA ANDA078040 State of Florida DOH Central Pharmacy RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 53808-0684_0db574c6-0270-4fbc-af7d-19cfdcc88e7c 53808-0684 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20130101 OTC MONOGRAPH FINAL part331 State of Florida DOH Central Pharmacy MAGNESIUM OXIDE 400 mg/1 53808-0685_165010e0-5a9f-4e65-be43-ddb6999b5666 53808-0685 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20130101 ANDA ANDA077751 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0686_9ee8ed6b-bedd-409f-9736-a23e75e05e48 53808-0686 HUMAN PRESCRIPTION DRUG Amlodipine AMLODIPINE BESYLATE TABLET ORAL 20130101 ANDA ANDA078231 State of Florida DOH Central Pharmacy AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53808-0687_d73a6e72-d76f-4d31-9e91-32cd709aef51 53808-0687 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130101 ANDA ANDA078332 State of Florida DOH Central Pharmacy CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 53808-0688_9a2813cb-5745-4ca0-95cd-57de74105ec5 53808-0688 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130101 ANDA ANDA077691 State of Florida DOH Central Pharmacy SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0689_954c5c83-5d35-4cc9-a5da-df5c74300415 53808-0689 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20130101 ANDA ANDA078955 State of Florida DOH Central Pharmacy PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0690_a137a53d-e0b8-4e5b-9569-cb28d1ed4d3e 53808-0690 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20130101 ANDA ANDA091576 State of Florida DOH Central Pharmacy MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 53808-0691_dca3de0d-f025-4602-af83-efd391b8623b 53808-0691 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130101 ANDA ANDA078225 State of Florida DOH Central Pharmacy TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 53808-0692_a6d8c6e6-4587-48b8-b9da-a32cf6f44790 53808-0692 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130101 ANDA ANDA076063 State of Florida DOH Central Pharmacy LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 53808-0693_f270b06b-e60d-41e3-88bc-9599737f8dba 53808-0693 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130101 ANDA ANDA077127 State of Florida DOH Central Pharmacy NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53808-0695_e5e7eb22-fc88-4fc8-a047-1d785435448a 53808-0695 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20130101 ANDA ANDA074984 State of Florida DOH Central Pharmacy DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 53808-0696_aff840f1-ccb7-4e19-bb26-194f414ff05d 53808-0696 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20130101 ANDA ANDA084364 State of Florida DOH Central Pharmacy TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 53808-0699_44db61fc-c25f-4c69-b466-00423c7ca9e8 53808-0699 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20130101 ANDA ANDA078556 State of Florida DOH Central Pharmacy DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 53808-0700_dd158c6f-db49-4875-a5f2-853947200bf1 53808-0700 HUMAN PRESCRIPTION DRUG Lisinopril LISINOPRIL TABLET ORAL 20090701 ANDA ANDA077622 State of Florida DOH Central Pharmacy LISINOPRIL 10 mg/1 53808-0701_0fe688ac-da62-4889-a8b8-82babe390ad3 53808-0701 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20090701 ANDA ANDA075944 State of Florida DOH Central Pharmacy LISINOPRIL 20 mg/1 53808-0702_68a98d1d-a74f-4d43-9ebe-c50795b3975b 53808-0702 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20090701 ANDA ANDA076071 State of Florida DOH Central Pharmacy LISINOPRIL 20 mg/1 53808-0703_27c6283e-54e1-4ae0-a07a-dc71d92a6de2 53808-0703 HUMAN PRESCRIPTION DRUG Lisinopril LISINOPRIL TABLET ORAL 20090701 ANDA ANDA076059 State of Florida DOH Central Pharmacy LISINOPRIL 20 mg/1 53808-0704_ad095c76-cd86-41c4-b54a-6a1db4fa200c 53808-0704 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20090701 ANDA ANDA079139 State of Florida DOH Central Pharmacy LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 53808-0705_fbd9e5c2-570f-4fa1-9ffd-adbf96cb4a5e 53808-0705 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 20090701 NDA NDA017812 State of Florida DOH Central Pharmacy LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 53808-0707_de0592d5-7e0e-41bb-af4d-62d1bdddb668 53808-0707 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE CAPSULE ORAL 20090701 ANDA ANDA073192 State of Florida DOH Central Pharmacy LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 53808-0712_45abd94e-142e-4da8-ad7b-566a18395935 53808-0712 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20090701 ANDA ANDA078170 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 53808-0713_b01de40c-1f85-4255-bcf2-31540bca206a 53808-0713 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA075967 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 53808-0717_45abd94e-142e-4da8-ad7b-566a18395935 53808-0717 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20090701 ANDA ANDA078170 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 53808-0718_b01de40c-1f85-4255-bcf2-31540bca206a 53808-0718 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA075967 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 53808-0720_b01de40c-1f85-4255-bcf2-31540bca206a 53808-0720 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA075967 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 53808-0722_7dc3385b-d2bb-472e-b05d-67124e346bb4 53808-0722 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20090701 ANDA ANDA071250 State of Florida DOH Central Pharmacy METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 53808-0723_7dc3385b-d2bb-472e-b05d-67124e346bb4 53808-0723 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20090701 ANDA ANDA072750 State of Florida DOH Central Pharmacy METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 53808-0725_f59d2f6d-b2ff-418e-92fc-e00ccd7d63ff 53808-0725 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20090701 ANDA ANDA076704 State of Florida DOH Central Pharmacy METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0728_f59d2f6d-b2ff-418e-92fc-e00ccd7d63ff 53808-0728 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20090701 ANDA ANDA076704 State of Florida DOH Central Pharmacy METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0730_81b9fca7-f47d-4293-87ae-856c4b1c5f96 53808-0730 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20090701 ANDA ANDA076900 State of Florida DOH Central Pharmacy ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0731_684d8704-b4f4-4c9a-a775-fa59a3299843 53808-0731 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20090701 ANDA ANDA074680 State of Florida DOH Central Pharmacy RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 53808-0733_fcc7ee36-3760-4231-ae19-faebde3dd638 53808-0733 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 20090701 ANDA ANDA072709 State of Florida DOH Central Pharmacy MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 53808-0734_fcc7ee36-3760-4231-ae19-faebde3dd638 53808-0734 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 20090701 ANDA ANDA072709 State of Florida DOH Central Pharmacy MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 53808-0735_63cbcedb-7dfd-4ec5-ae64-d6c87e1b2b5d 53808-0735 HUMAN PRESCRIPTION DRUG Mirtazapine MIRTAZAPINE TABLET ORAL 20090701 ANDA ANDA076541 State of Florida DOH Central Pharmacy MIRTAZAPINE 15 mg/1 53808-0736_63cbcedb-7dfd-4ec5-ae64-d6c87e1b2b5d 53808-0736 HUMAN PRESCRIPTION DRUG Mirtazapine MIRTAZAPINE TABLET ORAL 20090701 ANDA ANDA076541 State of Florida DOH Central Pharmacy MIRTAZAPINE 30 mg/1 53808-0737_63cbcedb-7dfd-4ec5-ae64-d6c87e1b2b5d 53808-0737 HUMAN PRESCRIPTION DRUG Mirtazapine MIRTAZAPINE TABLET ORAL 20090701 ANDA ANDA076541 State of Florida DOH Central Pharmacy MIRTAZAPINE 45 mg/1 53808-0738_88ea22b4-1004-478a-b914-09dd77dde766 53808-0738 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20090701 ANDA ANDA075927 State of Florida DOH Central Pharmacy NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53808-0739_e142bb87-30bf-4ef5-a58d-254f35faad1d 53808-0739 HUMAN PRESCRIPTION DRUG Naproxen NAPROXEN TABLET ORAL 20090701 ANDA ANDA074201 State of Florida DOH Central Pharmacy NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53808-0740_d8728514-ee4d-474e-a002-fa8a70f9eb10 53808-0740 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED ORAL 20090701 ANDA ANDA065093 State of Florida DOH Central Pharmacy AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 53808-0742_e46640dd-311d-4e68-9424-7c4c7ade7847 53808-0742 HUMAN PRESCRIPTION DRUG Naproxen Sodium NAPROXEN SODIUM TABLET, FILM COATED ORAL 20090701 ANDA ANDA074201 State of Florida DOH Central Pharmacy NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53808-0744_cb95c93f-4e5e-4ae7-a755-b24d2d6e6474 53808-0744 HUMAN PRESCRIPTION DRUG nifedipine NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 ANDA ANDA075108 State of Florida DOH Central Pharmacy NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53808-0746_596008d9-a14e-42a8-b2f4-799480123e7b 53808-0746 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20090701 ANDA ANDA075876 State of Florida DOH Central Pharmacy OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 53808-0747_80e61d72-77a8-4d3f-b251-7b3272351d33 53808-0747 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride OXYBUTYNIN CHLORIDE TABLET ORAL 20090701 ANDA ANDA071655 State of Florida DOH Central Pharmacy OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 53808-0748_051db7fe-e4d6-4022-a00a-069d14dbaf64 53808-0748 HUMAN PRESCRIPTION DRUG paroxetine PAROXETINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA075356 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0749_1738a5ed-a001-4b9f-b16e-e10b06833354 53808-0749 HUMAN PRESCRIPTION DRUG Paroxetine PAROXETINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA078406 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0750_051db7fe-e4d6-4022-a00a-069d14dbaf64 53808-0750 HUMAN PRESCRIPTION DRUG paroxetine PAROXETINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA075356 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0752_1738a5ed-a001-4b9f-b16e-e10b06833354 53808-0752 HUMAN PRESCRIPTION DRUG Paroxetine PAROXETINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA078406 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0753_051db7fe-e4d6-4022-a00a-069d14dbaf64 53808-0753 HUMAN PRESCRIPTION DRUG paroxetine PAROXETINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA075356 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0754_051db7fe-e4d6-4022-a00a-069d14dbaf64 53808-0754 HUMAN PRESCRIPTION DRUG paroxetine PAROXETINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA075356 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0755_0ea2345f-d110-4f6a-af82-cf862207127c 53808-0755 HUMAN PRESCRIPTION DRUG Allopurinol ALLOPURINOL TABLET ORAL 20090701 NDA NDA018832 State of Florida DOH Central Pharmacy ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 53808-0756_1738a5ed-a001-4b9f-b16e-e10b06833354 53808-0756 HUMAN PRESCRIPTION DRUG Paroxetine PAROXETINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA078406 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0757_b775b613-a690-459c-b0ea-2798a74df5e2 53808-0757 HUMAN PRESCRIPTION DRUG Pentoxifylline PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 20090701 ANDA ANDA075199 State of Florida DOH Central Pharmacy PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 53808-0758_176f8340-f270-4873-87e5-b53323a2b6ee 53808-0758 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 ANDA ANDA074425 State of Florida DOH Central Pharmacy PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 53808-0759_e30a8bdd-87ca-4886-a55e-d807763bd4c6 53808-0759 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED ORAL 20090701 ANDA ANDA065189 State of Florida DOH Central Pharmacy AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 53808-0760_51a71da6-5750-47fa-bf22-8f227ff4288b 53808-0760 HUMAN PRESCRIPTION DRUG Perphenazine PERPHENAZINE TABLET, FILM COATED ORAL 20090701 ANDA ANDA089685 State of Florida DOH Central Pharmacy PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0761_533b9303-6097-4eee-a802-d7623461b82a 53808-0761 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, SUGAR COATED ORAL 20090701 ANDA ANDA040226 State of Florida DOH Central Pharmacy PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0762_51a71da6-5750-47fa-bf22-8f227ff4288b 53808-0762 HUMAN PRESCRIPTION DRUG Perphenazine PERPHENAZINE TABLET, FILM COATED ORAL 20090701 ANDA ANDA089686 State of Florida DOH Central Pharmacy PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0763_510501a7-61be-4fa1-8120-4bd218a01d8d 53808-0763 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 20090701 NDA NDA020839 State of Florida DOH Central Pharmacy CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 53808-0764_9db1257e-0491-4c8d-85d6-37fa1f425cbd 53808-0764 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20090701 ANDA ANDA077987 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0765_c8f33b49-5160-402f-b094-249b29b0fad0 53808-0765 HUMAN PRESCRIPTION DRUG Pravastatin Sodium PRAVASTATIN SODIUM TABLET ORAL 20090701 ANDA ANDA076056 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0766_c8f33b49-5160-402f-b094-249b29b0fad0 53808-0766 HUMAN PRESCRIPTION DRUG Pravastatin Sodium PRAVASTATIN SODIUM TABLET ORAL 20090701 ANDA ANDA076056 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0767_74505e7d-79df-4432-83b4-dc03d441e0cd 53808-0767 HUMAN PRESCRIPTION DRUG EPZICOM abacavir sulfate and lamivudine TABLET, FILM COATED ORAL 20090701 NDA NDA021652 State of Florida DOH Central Pharmacy ABACAVIR SULFATE; LAMIVUDINE 600; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0768_c8f33b49-5160-402f-b094-249b29b0fad0 53808-0768 HUMAN PRESCRIPTION DRUG Pravastatin Sodium PRAVASTATIN SODIUM TABLET ORAL 20090701 ANDA ANDA076056 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0770_3144f373-fd53-433e-bcc3-7de919cfb475 53808-0770 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20090701 NDA NDA004782 State of Florida DOH Central Pharmacy ESTROGENS, CONJUGATED .625 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 53808-0771_d6ad4be2-e6ec-4e44-8609-fd9ec50aacab 53808-0771 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20090701 ANDA ANDA070176 State of Florida DOH Central Pharmacy PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0772_d6ad4be2-e6ec-4e44-8609-fd9ec50aacab 53808-0772 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20090701 ANDA ANDA070177 State of Florida DOH Central Pharmacy PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0773_293699e1-d0c8-4d54-b360-e76b26b7da68 53808-0773 HUMAN PRESCRIPTION DRUG PREZISTA darunavir ethanolate TABLET, FILM COATED ORAL 20090701 NDA NDA021976 State of Florida DOH Central Pharmacy DARUNAVIR ETHANOLATE 600 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] 53808-0774_8ec6d8b3-9152-4154-91ea-48ab5bfd1968 53808-0774 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20090701 ANDA ANDA075180 State of Florida DOH Central Pharmacy RANITIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 53808-0775_23799e22-8ede-40fd-a9cb-a5ba4fd484a0 53808-0775 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20090701 ANDA ANDA077824 State of Florida DOH Central Pharmacy RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 53808-0776_28f0dfb6-0724-413f-bd98-d8421482e9ff 53808-0776 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA074467 State of Florida DOH Central Pharmacy RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 53808-0781_cbb7cff7-62dd-4bb5-aee5-4202eb730940 53808-0781 HUMAN PRESCRIPTION DRUG Ribavirin RIBAVIRIN CAPSULE ORAL 20090701 ANDA ANDA076192 State of Florida DOH Central Pharmacy RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 53808-0782_e6e8d35d-d5c7-4149-9167-b7e2d0588bee 53808-0782 HUMAN PRESCRIPTION DRUG Ribavirin RIBAVIRIN TABLET, FILM COATED ORAL 20090701 ANDA ANDA077224 State of Florida DOH Central Pharmacy RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 53808-0783_df05a7ce-0e25-4c7c-a69d-1e1b9e13de61 53808-0783 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 State of Florida DOH Central Pharmacy RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 53808-0784_df05a7ce-0e25-4c7c-a69d-1e1b9e13de61 53808-0784 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 State of Florida DOH Central Pharmacy RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 53808-0786_df05a7ce-0e25-4c7c-a69d-1e1b9e13de61 53808-0786 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 State of Florida DOH Central Pharmacy RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 53808-0787_4eae84af-ae77-47c6-ade9-e78a26d33b59 53808-0787 HUMAN PRESCRIPTION DRUG Intelence Etravirine TABLET ORAL 20090701 NDA NDA022187 State of Florida DOH Central Pharmacy ETRAVIRINE 100 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0792_d080c03c-ff61-4a31-9a91-25b5a515d77a 53808-0792 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20090701 ANDA ANDA076052 State of Florida DOH Central Pharmacy SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0793_a77a8615-6c1e-4571-b228-7783cfb5c48d 53808-0793 HUMAN PRESCRIPTION DRUG Simvastatin SIMVASTATIN TABLET, FILM COATED ORAL 20090701 ANDA ANDA076285 State of Florida DOH Central Pharmacy SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0795_66893c23-b206-4107-ad2b-1af596b4c5c5 53808-0795 HUMAN PRESCRIPTION DRUG ZERIT stavudine CAPSULE, GELATIN COATED ORAL 20090701 NDA NDA020412 State of Florida DOH Central Pharmacy STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0796_e1a6cafb-dc98-4630-9cbe-519e08ab1691 53808-0796 HUMAN PRESCRIPTION DRUG Spironolactone SPIRONOLACTONE TABLET ORAL 20090701 ANDA ANDA040353 State of Florida DOH Central Pharmacy SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 53808-0797_bc8c902a-bbb9-46fb-ba2f-0da5862699ac 53808-0797 HUMAN PRESCRIPTION DRUG Sucralfate SUCRALFATE TABLET ORAL 20090701 ANDA ANDA070848 State of Florida DOH Central Pharmacy SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 53808-0798_af332a04-0159-48e0-a069-f30c617181c5 53808-0798 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20090701 ANDA ANDA076899 State of Florida DOH Central Pharmacy SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 53808-0799_c1d1c61f-8039-4ce0-aeae-e9834e88f032 53808-0799 HUMAN PRESCRIPTION DRUG Sulindac SULINDAC TABLET ORAL 20090701 ANDA ANDA073262 State of Florida DOH Central Pharmacy SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53808-0800_bf27bfc4-b913-4924-bebf-a0bdbaddcea5 53808-0800 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130101 ANDA ANDA077837 State of Florida DOH Central Pharmacy SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0801_cbe7f06f-5d03-478a-b878-e9149a9cc853 53808-0801 HUMAN PRESCRIPTION DRUG Emtriva emtricitabine CAPSULE ORAL 20090701 NDA NDA021500 State of Florida DOH Central Pharmacy EMTRICITABINE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0803_664e2ae4-54af-470c-80a6-039825757663 53808-0803 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE ORAL 20090701 ANDA ANDA074821 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 53808-0804_49974c21-8cf2-4f7f-b768-560e2fbe7b60 53808-0804 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET ORAL 20090701 ANDA ANDA071851 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 53808-0805_877e3186-0c6f-47e4-b946-2fe53d80ef12 53808-0805 HUMAN PRESCRIPTION DRUG Truvada emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20090701 NDA NDA021752 State of Florida DOH Central Pharmacy EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0806_28c48b4c-4ef3-4047-b3c3-3ef51ff98532 53808-0806 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20130101 ANDA ANDA090494 State of Florida DOH Central Pharmacy CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 53808-0807_a35648a5-edad-466e-97cf-fc1ce7993bce 53808-0807 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 ANDA ANDA074330 State of Florida DOH Central Pharmacy VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 53808-0808_46b0051f-5908-4d1d-967b-4085a0909b4a 53808-0808 HUMAN PRESCRIPTION DRUG Viramune nevirapine TABLET ORAL 20090701 NDA NDA020636 State of Florida DOH Central Pharmacy NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 53808-0809_d93799ad-308b-4f54-b8d5-07402cd8882e 53808-0809 HUMAN PRESCRIPTION DRUG Viracept NELFINAVIR MESYLATE TABLET, FILM COATED ORAL 20090701 NDA NDA021503 State of Florida DOH Central Pharmacy NELFINAVIR MESYLATE 625 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 53808-0810_bea0f43d-4f45-40d2-b4a4-3ac996bb1626 53808-0810 HUMAN PRESCRIPTION DRUG Viread tenofovir disoproxil fumarate TABLET, COATED ORAL 20090701 NDA NDA021356 State of Florida DOH Central Pharmacy TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 53808-0811_dd74d4f9-ed20-47b0-bb3d-4a8ad228a21e 53808-0811 HUMAN PRESCRIPTION DRUG ZIAGEN abacavir sulfate TABLET, FILM COATED ORAL 20090701 NDA NDA020977 State of Florida DOH Central Pharmacy ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0813_c8b695f2-24f9-4546-b94f-7fce9a5439dc 53808-0813 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20130101 ANDA ANDA070217 State of Florida DOH Central Pharmacy PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0814_123676fd-fb30-4627-b6e8-def7d4e41931 53808-0814 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20130101 ANDA ANDA072711 State of Florida DOH Central Pharmacy SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53808-0815_d73a6e72-d76f-4d31-9e91-32cd709aef51 53808-0815 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130101 ANDA ANDA078332 State of Florida DOH Central Pharmacy CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 53808-0816_9a2813cb-5745-4ca0-95cd-57de74105ec5 53808-0816 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130101 ANDA ANDA077691 State of Florida DOH Central Pharmacy SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0817_75e3fbcc-e08b-41de-83a3-090f7fb39643 53808-0817 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 20130101 ANDA ANDA071093 State of Florida DOH Central Pharmacy THIOTHIXENE 10 mg/1 Typical Antipsychotic [EPC] 53808-0819_a93001d2-6248-4c2b-b84a-a7458c232f0c 53808-0819 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA040209 State of Florida DOH Central Pharmacy TRIFLUOPERAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0820_d73a6e72-d76f-4d31-9e91-32cd709aef51 53808-0820 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130101 ANDA ANDA078332 State of Florida DOH Central Pharmacy CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 53808-0821_de44300b-0179-42f7-86cd-ae9b79501222 53808-0821 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131201 ANDA ANDA074556 State of Florida DOH Central Pharmacy ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 53808-0822_41c99d5e-a695-4aba-8131-6104068368c5 53808-0822 HUMAN OTC DRUG MAPAP Extra Strength Acetaminophen CAPSULE ORAL 20130101 OTC MONOGRAPH NOT FINAL part343 State of Florida DOH Central Pharmacy ACETAMINOPHEN 500 mg/1 53808-0823_51806be1-d5f5-4a7c-afba-12ebd6234980 53808-0823 HUMAN PRESCRIPTION DRUG ASACOL mesalamine TABLET, DELAYED RELEASE ORAL 20130101 NDA NDA019651 State of Florida DOH Central Pharmacy MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 53808-0825_6e264c7b-8a87-4f75-8644-ba41b9f4398b 53808-0825 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20130101 ANDA ANDA040715 State of Florida DOH Central Pharmacy BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 53808-0826_9405fe87-9769-4bd3-a38c-1fe354a02d7e 53808-0826 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20130101 ANDA ANDA040103 State of Florida DOH Central Pharmacy BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 53808-0827_61da2442-b0df-44ae-b055-a6aaef3ab5b3 53808-0827 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130101 ANDA ANDA076649 State of Florida DOH Central Pharmacy CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 53808-0828_df961314-befe-4003-b46a-03f711a8b627 53808-0828 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20130101 ANDA ANDA077901 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 53808-0829_598c0f12-a32a-4fca-a2e7-afee666bb964 53808-0829 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20130101 ANDA ANDA087056 State of Florida DOH Central Pharmacy CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 53808-0830_d7549854-f546-4224-af14-2aee940409da 53808-0830 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA072838 State of Florida DOH Central Pharmacy DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 53808-0831_970a776f-2cac-4d2e-be54-e10a3af85ec4 53808-0831 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130101 ANDA ANDA077567 State of Florida DOH Central Pharmacy DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 53808-0832_6366bd5f-d29d-4d9e-b932-b3b91b2e4b78 53808-0832 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20130101 ANDA ANDA062396 State of Florida DOH Central Pharmacy DOXYCYCLINE HYCLATE 100 mg/1 53808-0833_0b7b2424-cd18-4524-b974-5266a537dda3 53808-0833 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20130101 ANDA ANDA075479 State of Florida DOH Central Pharmacy ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 53808-0834_afaee673-4a3b-4204-b20b-4dd229c26dfd 53808-0834 HUMAN OTC DRUG Excedrin Extra Strength Acetaminophen, Aspirin (NSAID), and Caffeine TABLET, FILM COATED ORAL 20130101 OTC MONOGRAPH NOT FINAL part343 State of Florida DOH Central Pharmacy ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 53808-0835_b7ef153b-d459-49e9-ac4a-c7744a7fc9ed 53808-0835 HUMAN OTC DRUG EXCEDRIN MIGRAINE Acetaminophen, Aspirin (NSAID) and Caffeine TABLET, FILM COATED ORAL 20130101 NDA NDA020802 State of Florida DOH Central Pharmacy ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 53808-0836_4e5a0dbd-daa9-4d86-af17-4cd53ebed71d 53808-0836 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine hydrochloride CAPSULE ORAL 20120601 ANDA ANDA075207 State of Florida DOH Central Pharmacy FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0837_850b50af-9e8a-4272-a644-6531f1d54919 53808-0837 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20130101 ANDA ANDA075452 State of Florida DOH Central Pharmacy FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0838_0b2c2616-3c2a-40c7-b158-16a35a500cb7 53808-0838 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20130101 ANDA ANDA075034 State of Florida DOH Central Pharmacy GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 53808-0839_30926b4a-aab1-4299-b552-1b99dfd20cab 53808-0839 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20130101 ANDA ANDA070082 State of Florida DOH Central Pharmacy FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 53808-0840_b252f4a8-1e2d-48b0-9296-dc9681acdcf7 53808-0840 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20130101 ANDA ANDA070278 State of Florida DOH Central Pharmacy HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] 53808-0841_93b2b693-3119-426e-bcca-4ae59380c69a 53808-0841 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20130101 ANDA ANDA075907 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 53808-0842_f60eada4-f96e-4e0a-a370-932874aec744 53808-0842 HUMAN PRESCRIPTION DRUG Ketoconazole ketoconazole TABLET ORAL 20130101 ANDA ANDA075597 State of Florida DOH Central Pharmacy KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 53808-0843_00a2a441-b79b-408e-a906-f8292056e8f6 53808-0843 HUMAN PRESCRIPTION DRUG LAMIVUDINE lamivudine TABLET, FILM COATED ORAL 20130101 ANDA ANDA091606 State of Florida DOH Central Pharmacy LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0844_00a2a441-b79b-408e-a906-f8292056e8f6 53808-0844 HUMAN PRESCRIPTION DRUG LAMIVUDINE lamivudine TABLET, FILM COATED ORAL 20130101 ANDA ANDA091606 State of Florida DOH Central Pharmacy LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0846_ad9a1593-1009-4afd-8d15-4f324815d6b0 53808-0846 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130101 NDA NDA021210 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 53808-0848_4fb8b0cb-c11c-4a61-89b1-7296991ec647 53808-0848 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20120101 ANDA ANDA077095 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 53808-0849_e43cb91f-a1b4-4d46-beba-35f2057913a9 53808-0849 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20130101 ANDA ANDA077064 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 53808-0850_d4bf45c5-6b50-430a-84e6-c3d62fd2a9cf 53808-0850 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20130101 ANDA ANDA040350 State of Florida DOH Central Pharmacy METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 53808-0851_543b34f9-d0d4-47bb-ad9a-b3b7eaec442e 53808-0851 HUMAN PRESCRIPTION DRUG Nifedical XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130101 ANDA ANDA075289 State of Florida DOH Central Pharmacy NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53808-0852_5f18c60b-648b-404a-858f-00ddaa9b0be1 53808-0852 HUMAN PRESCRIPTION DRUG Stavudine stavudine CAPSULE ORAL 20130101 ANDA ANDA079069 State of Florida DOH Central Pharmacy STAVUDINE 20 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0856_db45c4b3-9d13-44dd-9b8d-b2ae6a2c4c36 53808-0856 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20130101 ANDA ANDA074253 State of Florida DOH Central Pharmacy BUSPIRONE HYDROCHLORIDE 10 mg/1 53808-0858_a1e16d44-3bdd-4efd-bad2-9416a826be83 53808-0858 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET, CHEWABLE ORAL 20130101 ANDA ANDA075712 State of Florida DOH Central Pharmacy CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 53808-0859_d73a6e72-d76f-4d31-9e91-32cd709aef51 53808-0859 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130101 ANDA ANDA078332 State of Florida DOH Central Pharmacy CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 53808-0862_9fc869dc-7e21-43b0-8170-e25bb74365f2 53808-0862 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA073541 State of Florida DOH Central Pharmacy CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 53808-0863_9ae2f08d-e20b-46e3-b0f8-67118a65f662 53808-0863 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20130101 ANDA ANDA078012 State of Florida DOH Central Pharmacy GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 53808-0867_1787bada-5b5a-4e0c-8bf7-4b695544eaa5 53808-0867 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130101 ANDA ANDA075743 State of Florida DOH Central Pharmacy LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 53808-0868_5584341f-746e-4791-a1fa-36b5e8c865d1 53808-0868 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130101 ANDA ANDA076059 State of Florida DOH Central Pharmacy LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 53808-0870_1787bada-5b5a-4e0c-8bf7-4b695544eaa5 53808-0870 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130101 ANDA ANDA075743 State of Florida DOH Central Pharmacy LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 53808-0871_857ee4e5-bcbf-4e1b-afb2-a98507a8d3bb 53808-0871 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130101 NDA NDA021282 State of Florida DOH Central Pharmacy GUAIFENESIN 600 mg/1 53808-0872_5e9234b6-72b6-443a-8a75-a68de18e98c9 53808-0872 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20130101 ANDA ANDA078432 State of Florida DOH Central Pharmacy NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53808-0873_7e123e63-4a3a-4a7a-8b45-e3d5ef102106 53808-0873 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20130101 ANDA ANDA074625 State of Florida DOH Central Pharmacy OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 53808-0874_dcafbc91-8eb4-4682-bf89-b16dd412be7a 53808-0874 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20130101 ANDA ANDA077751 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0875_dcafbc91-8eb4-4682-bf89-b16dd412be7a 53808-0875 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20130101 ANDA ANDA077751 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0876_76437cab-3ca6-4e54-9c58-803f50404969 53808-0876 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20130101 ANDA ANDA076288 State of Florida DOH Central Pharmacy RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 53808-0877_2c92f80c-2f2d-472c-9937-ee9c4e6ab1a0 53808-0877 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20130101 ANDA ANDA061837 State of Florida DOH Central Pharmacy TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 53808-0878_0602ce68-264c-4b34-b2f0-fb0f623bbde3 53808-0878 HUMAN PRESCRIPTION DRUG Zidovudine zidovudine TABLET, FILM COATED ORAL 20130101 ANDA ANDA078922 State of Florida DOH Central Pharmacy ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0880_d47df14d-46f6-4b35-ae73-4a9b59825c31 53808-0880 HUMAN OTC DRUG Allergy Time Chlorpheniramine Maleate TABLET ORAL 20130101 OTC MONOGRAPH FINAL part341 State of Florida DOH Central Pharmacy CHLORPHENIRAMINE MALEATE 4 mg/1 53808-0881_fe96ad53-5780-4544-89c5-05f18b25b4c7 53808-0881 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA078643 State of Florida DOH Central Pharmacy CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 53808-0882_104c0170-6b56-415e-90b4-85f777ba2792 53808-0882 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20130101 ANDA ANDA090527 State of Florida DOH Central Pharmacy HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 53808-0883_16798eff-96a1-4d88-8ece-b75a2e7dba48 53808-0883 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130101 ANDA ANDA040809 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 53808-0884_9d1794d1-822d-4ca7-9cad-6582a965df9a 53808-0884 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20140101 ANDA ANDA079139 State of Florida DOH Central Pharmacy LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 53808-0885_2254481e-d8ad-4f6a-946a-aad4716d6fbf 53808-0885 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20140101 ANDA ANDA040226 State of Florida DOH Central Pharmacy PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0886_1411c929-e5e8-49cd-a165-947ba82b80f4 53808-0886 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20140101 ANDA ANDA201507 State of Florida DOH Central Pharmacy HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 53808-0887_ac228abb-ea52-4688-a175-8ad02b651fa0 53808-0887 HUMAN PRESCRIPTION DRUG Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20140101 NDA NDA203100 State of Florida DOH Central Pharmacy COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 150; 150; 200; 300 mg/1; mg/1; mg/1; mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0888_f34f024f-04c2-4a36-83a4-5b2a75aaa8fc 53808-0888 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20140101 ANDA ANDA077321 State of Florida DOH Central Pharmacy LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 53808-0889_425b8fc9-64d0-435f-9e42-1fc2d19b5be3 53808-0889 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20140101 ANDA ANDA077068 State of Florida DOH Central Pharmacy BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 53808-0890_9b9bc863-13d3-4a5c-83ac-5dca8b28d37b 53808-0890 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20140101 ANDA ANDA078040 State of Florida DOH Central Pharmacy RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 53808-0891_c8b695f2-24f9-4546-b94f-7fce9a5439dc 53808-0891 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20140101 ANDA ANDA070218 State of Florida DOH Central Pharmacy PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0892_cc71faa6-629b-4736-b8b0-5c7b971d54b7 53808-0892 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20140101 ANDA ANDA090428 State of Florida DOH Central Pharmacy LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 53808-0893_50cf8e19-72f4-4202-895f-cc9f81c2ca6f 53808-0893 HUMAN PRESCRIPTION DRUG EPIVIR HBV lamivudine TABLET, FILM COATED ORAL 20140101 NDA NDA021003 State of Florida DOH Central Pharmacy LAMIVUDINE 100 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0894_de44300b-0179-42f7-86cd-ae9b79501222 53808-0894 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20140101 ANDA ANDA074556 State of Florida DOH Central Pharmacy ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 53808-0895_30dbb679-87a4-4823-b61b-f4b9d8078955 53808-0895 HUMAN PRESCRIPTION DRUG COMBIVIR lamivudine and zidovudine TABLET, FILM COATED ORAL 20140101 NDA NDA020857 State of Florida DOH Central Pharmacy LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0896_cc71faa6-629b-4736-b8b0-5c7b971d54b7 53808-0896 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20140101 ANDA ANDA090428 State of Florida DOH Central Pharmacy LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 53808-0898_2408db70-f2dd-40d6-8480-a420400b828f 53808-0898 HUMAN PRESCRIPTION DRUG Nifedipine Extended Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20140101 ANDA ANDA077899 State of Florida DOH Central Pharmacy NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53808-0899_da42f97f-21e6-4847-9b8d-9975b6be3ccc 53808-0899 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 20140101 ANDA ANDA040161 State of Florida DOH Central Pharmacy DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 53808-0900_66c085b7-3ec3-43b4-a095-e04cf8d7a76a 53808-0900 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20090701 ANDA ANDA078512 State of Florida DOH Central Pharmacy ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-0902_8bc7b7df-28fe-4764-947f-a3999eafe079 53808-0902 HUMAN OTC DRUG EXTRA STRENGTH STOOL SOFTENER LAXATIVE DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140101 OTC MONOGRAPH NOT FINAL part334 State of Florida DOH Central Pharmacy DOCUSATE SODIUM 250 mg/1 53808-0904_d18df402-9731-472c-883c-a31ddea32289 53808-0904 HUMAN PRESCRIPTION DRUG benztropine mesylate BENZTROPINE MESYLATE TABLET ORAL 20090701 ANDA ANDA040103 State of Florida DOH Central Pharmacy BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 53808-0905_19ef92d2-2d50-4b5e-ae22-7d734ca29f15 53808-0905 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20140101 NDA AUTHORIZED GENERIC NDA021160 State of Florida DOH Central Pharmacy CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 53808-0906_3b9c1dbd-4ce0-45bc-a469-a688ec2b0bae 53808-0906 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20140101 ANDA ANDA077042 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0907_db45c4b3-9d13-44dd-9b8d-b2ae6a2c4c36 53808-0907 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20140101 ANDA ANDA074253 State of Florida DOH Central Pharmacy BUSPIRONE HYDROCHLORIDE 15 mg/1 53808-0908_b5efba99-807d-4778-b769-e95c960a9e86 53808-0908 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA075491 State of Florida DOH Central Pharmacy BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 53808-0909_1c49c40e-091d-45ac-afdc-fbc7172c3e5c 53808-0909 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20140101 ANDA ANDA078707 State of Florida DOH Central Pharmacy RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 53808-0910_b5efba99-807d-4778-b769-e95c960a9e86 53808-0910 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA075491 State of Florida DOH Central Pharmacy BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 53808-0911_e4a7f215-ee57-4a42-9cc8-8656a08f45ea 53808-0911 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090701 ANDA ANDA074505 State of Florida DOH Central Pharmacy CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 53808-0912_e4a7f215-ee57-4a42-9cc8-8656a08f45ea 53808-0912 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090701 ANDA ANDA074505 State of Florida DOH Central Pharmacy CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 53808-0913_18def499-cbff-49a0-bdf7-dd5d38fc6f01 53808-0913 HUMAN PRESCRIPTION DRUG Carbamazepine CARBAMAZEPINE TABLET ORAL 20090701 ANDA ANDA074649 State of Florida DOH Central Pharmacy CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 53808-0914_287faa58-5c20-41cd-b83d-7c3e048b1c39 53808-0914 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET ORAL 20090701 ANDA ANDA071017 State of Florida DOH Central Pharmacy SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 53808-0915_18def499-cbff-49a0-bdf7-dd5d38fc6f01 53808-0915 HUMAN PRESCRIPTION DRUG Carbamazepine CARBAMAZEPINE TABLET ORAL 20090701 ANDA ANDA075948 State of Florida DOH Central Pharmacy CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 53808-0916_18def499-cbff-49a0-bdf7-dd5d38fc6f01 53808-0916 HUMAN PRESCRIPTION DRUG Carbamazepine CARBAMAZEPINE TABLET ORAL 20090701 ANDA ANDA074649 State of Florida DOH Central Pharmacy CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 53808-0918_bd78c370-cd5d-49c8-ab17-ff01d75067e5 53808-0918 HUMAN OTC DRUG FERROUS SULFATE IRON SUPPLEMENT TABLET ORAL 20140101 UNAPPROVED DRUG OTHER State of Florida DOH Central Pharmacy FERROUS SULFATE 325 mg/1 53808-0919_08a351d4-fd58-4e26-a2ee-51cb4b433cba 53808-0919 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20140101 ANDA ANDA078155 State of Florida DOH Central Pharmacy SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0920_969c5ab2-0b80-4364-aaa1-342832e06b8f 53808-0920 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20140101 ANDA ANDA202468 State of Florida DOH Central Pharmacy MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 53808-0921_3a027eb2-61bb-411d-ad6b-8f6686a1478d 53808-0921 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20140101 ANDA ANDA078235 State of Florida DOH Central Pharmacy TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 53808-0922_9790adbf-4b4a-4ed1-8e64-bdd108059c60 53808-0922 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20140101 ANDA ANDA077032 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0923_f119023a-c0b0-4201-ad2a-3ac5ef3e2fbc 53808-0923 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075614 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 53808-0924_30f99c0e-3a3b-44a9-8a4c-89a3e88d665c 53808-0924 HUMAN PRESCRIPTION DRUG chlorpromazine hydrochloride CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED ORAL 20090701 ANDA ANDA083386 State of Florida DOH Central Pharmacy CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0925_30f99c0e-3a3b-44a9-8a4c-89a3e88d665c 53808-0925 HUMAN PRESCRIPTION DRUG chlorpromazine hydrochloride CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED ORAL 20090701 ANDA ANDA083386 State of Florida DOH Central Pharmacy CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0926_df961314-befe-4003-b46a-03f711a8b627 53808-0926 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20140101 ANDA ANDA077901 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 53808-0927_6a01d144-b6fe-43fe-bd5c-02552e94529f 53808-0927 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20140101 ANDA ANDA078034 State of Florida DOH Central Pharmacy SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0928_30f99c0e-3a3b-44a9-8a4c-89a3e88d665c 53808-0928 HUMAN PRESCRIPTION DRUG chlorpromazine hydrochloride CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED ORAL 20090701 ANDA ANDA083386 State of Florida DOH Central Pharmacy CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0929_3da29061-14bf-448a-bf5b-2c4b7f379482 53808-0929 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20140101 ANDA ANDA090637 State of Florida DOH Central Pharmacy ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 53808-0930_344b0ac9-7bea-4167-8b70-3a000fb50823 53808-0930 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075498 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 53808-0931_30f99c0e-3a3b-44a9-8a4c-89a3e88d665c 53808-0931 HUMAN PRESCRIPTION DRUG chlorpromazine hydrochloride CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED ORAL 20090701 ANDA ANDA083386 State of Florida DOH Central Pharmacy CHLORPROMAZINE HYDROCHLORIDE 200 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0932_b9904b22-7c79-463b-9441-709b1610a84d 53808-0932 HUMAN PRESCRIPTION DRUG Topiramate TOPIRAMATE TABLET ORAL 20090701 ANDA ANDA076575 State of Florida DOH Central Pharmacy TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 53808-0933_6ba4824d-44d7-44e8-84ab-4e87dfec5674 53808-0933 HUMAN PRESCRIPTION DRUG Amantadine HCl AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140101 ANDA ANDA078720 State of Florida DOH Central Pharmacy AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 53808-0934_9228edac-c7c3-47ef-83a4-b98c7fd4b569 53808-0934 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA078281 State of Florida DOH Central Pharmacy PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 53808-0935_87b78997-78ac-4e89-93c0-6c53a08bcbdd 53808-0935 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA090074 State of Florida DOH Central Pharmacy PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 53808-0936_9046b735-e30d-4fad-82a7-84a429ddd8eb 53808-0936 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140101 ANDA ANDA090700 State of Florida DOH Central Pharmacy VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 53808-0937_d421d001-da09-424c-8440-f4b6761c1079 53808-0937 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20140101 ANDA ANDA078554 State of Florida DOH Central Pharmacy VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0938_2254481e-d8ad-4f6a-946a-aad4716d6fbf 53808-0938 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20140101 ANDA ANDA040226 State of Florida DOH Central Pharmacy PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 53808-0939_790def26-67a9-4965-949a-61e6ab5dfef2 53808-0939 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20140101 ANDA ANDA065229 State of Florida DOH Central Pharmacy CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 53808-0940_0a07f0df-9050-41bb-a892-f97fe0731ef7 53808-0940 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA079163 State of Florida DOH Central Pharmacy DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 53808-0942_a4cec611-3775-4a0b-840d-677a7bf592df 53808-0942 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 20140101 NDA AUTHORIZED GENERIC NDA020329 State of Florida DOH Central Pharmacy GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 53808-0943_e8963d24-7f88-43f8-9aee-4c69936c3bb8 53808-0943 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20090701 ANDA ANDA077901 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 53808-0946_e3450a89-d439-4835-a9ca-fee52563bdcf 53808-0946 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20140101 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 53808-0947_e8963d24-7f88-43f8-9aee-4c69936c3bb8 53808-0947 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20090701 ANDA ANDA077901 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 53808-0948_1d3cc383-e493-43a8-a6d7-d3995c29e670 53808-0948 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20090701 ANDA ANDA078218 State of Florida DOH Central Pharmacy CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 53808-0949_7431eb5a-a173-43a9-9a76-e873c59ebd12 53808-0949 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20140101 ANDA ANDA040734 State of Florida DOH Central Pharmacy METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 53808-0950_087ab315-05c7-408a-85ab-e972c222bf89 53808-0950 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA040537 State of Florida DOH Central Pharmacy CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 53808-0951_0b17581a-4adf-4da1-ad3b-f15ebe08eb97 53808-0951 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20140101 NDA AUTHORIZED GENERIC NDA020702 State of Florida DOH Central Pharmacy ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0952_6a01d144-b6fe-43fe-bd5c-02552e94529f 53808-0952 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20140101 ANDA ANDA078034 State of Florida DOH Central Pharmacy SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0953_a35648a5-edad-466e-97cf-fc1ce7993bce 53808-0953 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 ANDA ANDA073568 State of Florida DOH Central Pharmacy VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 53808-0954_70172300-efa7-4c36-a272-1886d75ef62d 53808-0954 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline TABLET, FILM COATED ORAL 20140101 ANDA ANDA078626 State of Florida DOH Central Pharmacy SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0956_27a1eeb9-0064-48f8-9e34-91fdb455e818 53808-0956 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20140101 ANDA ANDA040489 State of Florida DOH Central Pharmacy METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 53808-0957_13f84dd6-0543-485f-a14e-b830a4f29c2d 53808-0957 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA090797 State of Florida DOH Central Pharmacy PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 53808-0958_c6a99364-0595-4fbc-baf8-dde5513b8c34 53808-0958 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20140101 NDA NDA021402 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 53808-0959_68e4fb9f-b9e8-4411-9631-1dd26bc40975 53808-0959 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20140101 ANDA ANDA090548 State of Florida DOH Central Pharmacy ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-0960_d97aebf0-524b-4ed3-8417-38068870603d 53808-0960 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20140101 ANDA ANDA040788 State of Florida DOH Central Pharmacy HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 53808-0961_83c2dd06-d867-4af8-8f36-7f05bf243dde 53808-0961 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20140101 ANDA ANDA090510 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 53808-0962_00f6952b-d14b-462b-8881-f5aacaa44f1e 53808-0962 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20090701 ANDA ANDA062031 State of Florida DOH Central Pharmacy DOXYCYCLINE HYCLATE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 53808-0963_ce8f069a-db9a-4f98-856f-cccc4fb48d45 53808-0963 HUMAN OTC DRUG Leader Fiber Calcium polycarbophil TABLET, FILM COATED ORAL 20140101 OTC MONOGRAPH NOT FINAL part334 State of Florida DOH Central Pharmacy CALCIUM POLYCARBOPHIL 625 mg/1 53808-0966_23f7f4ad-800c-4d98-a604-3c45b2842841 53808-0966 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20090701 ANDA ANDA075483 State of Florida DOH Central Pharmacy ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 53808-0967_ebf84f23-3beb-4480-9485-3b5f4a883943 53808-0967 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090701 ANDA ANDA090278 State of Florida DOH Central Pharmacy TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 53808-0970_6505df44-aafe-42d9-ac5d-a517238f55ee 53808-0970 HUMAN PRESCRIPTION DRUG Warfarin Sodium WARFARIN SODIUM TABLET ORAL 20090701 ANDA ANDA040301 State of Florida DOH Central Pharmacy WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 53808-0972_ec8d1d34-d828-493d-b145-da4f4e2725ea 53808-0972 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 NDA NDA019152 State of Florida DOH Central Pharmacy VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 53808-0976_d21388e7-ca03-4759-b7b7-046672762e8e 53808-0976 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20130101 ANDA ANDA077048 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0977_7287877c-326f-4bf6-8dd8-3d99b6364bb6 53808-0977 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride ETHAMBUTOL HYDROCHLORIDE TABLET ORAL 20090701 NDA NDA016320 State of Florida DOH Central Pharmacy ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] 53808-0978_eb3ec1d7-5abd-466c-b522-43d828bf787b 53808-0978 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20130101 ANDA ANDA090467 State of Florida DOH Central Pharmacy LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 53808-0979_10479dd1-9ce9-4090-a027-2e14873059da 53808-0979 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20130101 ANDA ANDA091426 State of Florida DOH Central Pharmacy SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 53808-0981_e3305dd9-e369-4db8-9274-f94fca384ea8 53808-0981 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20130101 ANDA ANDA090828 State of Florida DOH Central Pharmacy SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 53808-0982_c0b718f4-95ea-4a9a-b926-4b9f16dc0714 53808-0982 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20130101 ANDA ANDA090430 State of Florida DOH Central Pharmacy THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 53808-0983_610961c9-4e0f-4e45-83d8-eb40da8a101e 53808-0983 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20130101 ANDA ANDA071251 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 53808-0985_6505df44-aafe-42d9-ac5d-a517238f55ee 53808-0985 HUMAN PRESCRIPTION DRUG Warfarin Sodium WARFARIN SODIUM TABLET ORAL 20090701 ANDA ANDA040301 State of Florida DOH Central Pharmacy WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 53808-0986_e45a4c59-0aa7-471a-b766-501493fd0410 53808-0986 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride TABLET ORAL 20090701 ANDA ANDA075049 State of Florida DOH Central Pharmacy FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0988_e45a4c59-0aa7-471a-b766-501493fd0410 53808-0988 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride TABLET ORAL 20090701 ANDA ANDA075049 State of Florida DOH Central Pharmacy FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-0989_6505df44-aafe-42d9-ac5d-a517238f55ee 53808-0989 HUMAN PRESCRIPTION DRUG Warfarin Sodium WARFARIN SODIUM TABLET ORAL 20090701 ANDA ANDA040301 State of Florida DOH Central Pharmacy WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 53808-0990_a6299f1c-1ddb-4da4-a38d-2cb34eca0c02 53808-0990 HUMAN PRESCRIPTION DRUG TRIZIVIR abacavir sulfate, lamivudine, and zidovudine TABLET, FILM COATED ORAL 20130201 NDA NDA021205 State of Florida DOH Central Pharmacy ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE 300; 150; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 53808-0994_6505df44-aafe-42d9-ac5d-a517238f55ee 53808-0994 HUMAN PRESCRIPTION DRUG Warfarin Sodium WARFARIN SODIUM TABLET ORAL 20090701 ANDA ANDA040301 State of Florida DOH Central Pharmacy WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 53808-0997_6505df44-aafe-42d9-ac5d-a517238f55ee 53808-0997 HUMAN PRESCRIPTION DRUG Warfarin Sodium WARFARIN SODIUM TABLET ORAL 20090701 ANDA ANDA040301 State of Florida DOH Central Pharmacy WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 53808-0998_3788997e-3197-4576-b1e9-3233d05d506a 53808-0998 HUMAN PRESCRIPTION DRUG Furosemide FUROSEMIDE TABLET ORAL 20090701 ANDA ANDA078010 State of Florida DOH Central Pharmacy FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 53808-1008_76954f50-9eb3-4b27-a0a9-13cb5f023e14 53808-1008 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20141101 ANDA ANDA091650 State of Florida DOH Central Pharmacy ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-1012_9d934582-4995-47b0-a368-c93be846e43b 53808-1012 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20141101 ANDA ANDA073025 State of Florida DOH Central Pharmacy ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-1014_13e93461-6356-4a9a-8836-0d32f20d4791 53808-1014 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20141101 ANDA ANDA090168 State of Florida DOH Central Pharmacy BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 53808-1015_13e93461-6356-4a9a-8836-0d32f20d4791 53808-1015 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20141101 ANDA ANDA090168 State of Florida DOH Central Pharmacy BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 53808-1020_13e93461-6356-4a9a-8836-0d32f20d4791 53808-1020 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20141101 ANDA ANDA090168 State of Florida DOH Central Pharmacy BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 53808-1026_3da29061-14bf-448a-bf5b-2c4b7f379482 53808-1026 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20141001 ANDA ANDA090637 State of Florida DOH Central Pharmacy ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 53808-1029_76ca1035-dc48-4c4d-90e3-0d1456d0e604 53808-1029 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20141101 ANDA ANDA078414 State of Florida DOH Central Pharmacy AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 53808-1034_9916a3b5-9e92-4248-8709-a4f0a265f39a 53808-1034 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength TABLET ORAL 20140101 OTC MONOGRAPH FINAL part343 State of Florida DOH Central Pharmacy ASPIRIN 325 mg/1 53808-1035_68e4fb9f-b9e8-4411-9631-1dd26bc40975 53808-1035 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20140101 ANDA ANDA090548 State of Florida DOH Central Pharmacy ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-1036_425b8fc9-64d0-435f-9e42-1fc2d19b5be3 53808-1036 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20140101 ANDA ANDA077156 State of Florida DOH Central Pharmacy BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 53808-1037_efb513f9-ec12-457e-a84f-8ad76f4fac47 53808-1037 HUMAN PRESCRIPTION DRUG Citalopram citalopram hydrobromide TABLET, FILM COATED ORAL 20140101 ANDA ANDA077046 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-1038_9790adbf-4b4a-4ed1-8e64-bdd108059c60 53808-1038 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20140101 ANDA ANDA077032 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 53808-1039_92de62e2-6728-432e-9463-c136b381c204 53808-1039 HUMAN PRESCRIPTION DRUG cyclobenzaprine hydrochloride cyclobenzaprine hydrochloride TABLET ORAL 20140101 ANDA ANDA077563 State of Florida DOH Central Pharmacy CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 53808-1040_546554b9-c902-40ad-a025-ebf3534f4272 53808-1040 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE ORAL 20140101 ANDA ANDA040765 State of Florida DOH Central Pharmacy PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 53808-1041_2a74eb4a-6f94-4b7a-9234-8fc9339d7b6a 53808-1041 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20140101 ANDA ANDA080937 State of Florida DOH Central Pharmacy ISONIAZID 300 mg/1 Antimycobacterial [EPC] 53808-1042_f9e0812b-a688-4061-a457-0d0a350f457e 53808-1042 HUMAN PRESCRIPTION DRUG LEVETIRACETAM Levetiracetam TABLET, FILM COATED ORAL 20140101 ANDA ANDA090906 State of Florida DOH Central Pharmacy LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 53808-1043_eb3ec1d7-5abd-466c-b522-43d828bf787b 53808-1043 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20140101 ANDA ANDA090467 State of Florida DOH Central Pharmacy LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 53808-1044_62654411-46c6-4271-9d9d-d6716eaa5dd8 53808-1044 HUMAN PRESCRIPTION DRUG METHIMAZOLE METHIMAZOLE TABLET ORAL 20140101 ANDA ANDA202068 State of Florida DOH Central Pharmacy METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 53808-1045_d8347f6b-4a48-42bc-acdc-0612c4659018 53808-1045 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20140101 ANDA ANDA090200 State of Florida DOH Central Pharmacy METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 53808-1046_c344a13e-8238-4535-8661-b8752ba4893b 53808-1046 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20140101 ANDA ANDA074644 State of Florida DOH Central Pharmacy METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53808-1047_7e19a290-e67f-4925-8efc-30bb45d9f0d7 53808-1047 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA077058 State of Florida DOH Central Pharmacy PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 53808-1048_1c49c40e-091d-45ac-afdc-fbc7172c3e5c 53808-1048 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20140101 ANDA ANDA078707 State of Florida DOH Central Pharmacy RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 53808-1049_08a351d4-fd58-4e26-a2ee-51cb4b433cba 53808-1049 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20140101 ANDA ANDA078155 State of Florida DOH Central Pharmacy SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-1050_08a351d4-fd58-4e26-a2ee-51cb4b433cba 53808-1050 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20140101 ANDA ANDA078155 State of Florida DOH Central Pharmacy SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-1052_cd15fb45-c939-4336-b74f-02530048179b 53808-1052 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20140101 ANDA ANDA075576 State of Florida DOH Central Pharmacy OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 53808-1053_624f39af-a037-4e03-8ad0-7f05245625d4 53808-1053 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20140101 ANDA ANDA091305 State of Florida DOH Central Pharmacy NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 53808-1054_e3450a89-d439-4835-a9ca-fee52563bdcf 53808-1054 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20130101 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 53808-1055_da42f97f-21e6-4847-9b8d-9975b6be3ccc 53808-1055 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 20130101 ANDA ANDA040204 State of Florida DOH Central Pharmacy DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 53808-1066_4c892a60-2a09-4a71-aff4-40d881fd7de4 53808-1066 HUMAN PRESCRIPTION DRUG Amiodarone hydrochloride Amiodarone hydrochloride TABLET ORAL 20141101 ANDA ANDA079029 State of Florida DOH Central Pharmacy AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 53808-1067_76954f50-9eb3-4b27-a0a9-13cb5f023e14 53808-1067 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20141101 ANDA ANDA091650 State of Florida DOH Central Pharmacy ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 53808-1074_96a6937b-dc4b-4555-b544-1d1841981ca9 53808-1074 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20141101 ANDA ANDA073457 State of Florida DOH Central Pharmacy ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 53817-001_9bd554e7-c549-46dc-8914-b29ce6aa2d48 53817-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850301 UNAPPROVED MEDICAL GAS Alloy Oxygen & Welding Supply Co. Inc. OXYGEN 992 mL/L 53828-001_7d84b946-1881-41d9-a3f3-9c67e98b69e4 53828-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19350101 UNAPPROVED MEDICAL GAS Rochester Welding Supply Corp. OXYGEN 99 L/100L 53828-006_63c30b69-4868-4214-82a1-e2868acf2db9 53828-006 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19350101 UNAPPROVED MEDICAL GAS Rochester Welding Supply Corp. NITROGEN 99 L/100L 53835-0001_2facff60-ca7c-4cdd-9757-fef64612218e 53835-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19860101 UNAPPROVED MEDICAL GAS Heckman Healthcare Service & Supplies Inc OXYGEN 99 L/100L 53852-0001_2ebdf02f-3bbc-4282-8928-db5a24a0c102 53852-0001 HUMAN OTC DRUG Smoke Remedy Avena sativa, Caladium seguinum, Calcarea phosphorica, Daphne indica, Eugenia jambosa, Ignatia amara, Kali phosphoricum, Nux vomica, Plantago major, Staphysagria LIQUID ORAL 20100928 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC AVENA SATIVA FLOWERING TOP; DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; PLANTAGO MAJOR; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SYZYGIUM JAMBOS SEED; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL 53852-0002_335fb129-7d23-41f6-a100-899a929da395 53852-0002 HUMAN OTC DRUG Smoke Remedy Avena sativa, Caladium seguinum, Calcarea phosphorica, Daphne indica, Eugenia jambosa, Ignatia amara, Kali phosphoricum, Nux vomica, Plantago major, Staphysagria LIQUID ORAL 20110210 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC AVENA SATIVA FLOWERING TOP; DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; PLANTAGO MAJOR; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SYZYGIUM JAMBOS SEED; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL 53852-0003_1ec39f75-905d-408f-93fb-bb8be6eb1857 53852-0003 HUMAN OTC DRUG Lung Remedy Phase 2 Carbo vegetabilis, Bromium, Lobelia inflata, Phosphorus, Silicea LIQUID ORAL 20121029 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC ACTIVATED CHARCOAL; BROMINE; LOBELIA INFLATA; PHOSPHORUS; SILICON DIOXIDE 10; 10; 10; 10; 10 [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL 53852-0004_f8c5330e-51aa-482a-9171-b328ce73837c 53852-0004 HUMAN OTC DRUG Lung Remedy Phase 3 Carbo vegetabilis, Bromium, Lobelia inflata, Phosphorus, Silicea LIQUID ORAL 20090714 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC ACTIVATED CHARCOAL; BROMINE; LOBELIA INFLATA; PHOSPHORUS; SILICON DIOXIDE 10; 10; 10; 10; 10 [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL 53852-0005_273680fb-11a4-4082-8f94-5bdf9ace8a8c 53852-0005 HUMAN OTC DRUG D-TOX Remedy Antimonium tartaricum, Bromium, Bryonia, Carbo vegetabilis, Carduus marianus, Echinacea purpurea, Hepar sulphuris calcareum, Kali bichromicum, Lobelia inflata, Phosphorus, Phytolacca decandra, Silicea, Solidago virgaurea, Spongia tosta, Sulphur iodatum LIQUID ORAL 20140508 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC ACTIVATED CHARCOAL; ANTIMONY POTASSIUM TARTRATE; BROMINE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ECHINACEA PURPUREA; LOBELIA INFLATA; MILK THISTLE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SPONGIA OFFICINALIS SKELETON, ROASTED; SULFUR IODIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL 53852-0006_4710f9be-3441-4adf-8326-a070ecde8125 53852-0006 HUMAN OTC DRUG Weight Away Remedy kali bichromicum, calcarea carbonica, antimonium crudum, capsicum annuu, sabadilla, fucus vesiculosus, graphites, ammonium muriaticum, anacardium orientale, oleander, kali carbonicum, staphysagria, ammonium carbonicum, ferrum metallicum LIQUID ORAL 20100716 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC AMMONIUM CARBONATE; AMMONIUM CHLORIDE; ANTIMONY TRISULFIDE; CAPSICUM; DELPHINIUM STAPHISAGRIA SEED; FUCUS VESICULOSUS; GRAPHITE; IRON; NERIUM OLEANDER LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; POTASSIUM DICHROMATE; SCHOENOCAULON OFFICINALE SEED; SEMECARPUS ANACARDIUM JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL 53852-0007_5280057c-4c84-4339-a3e9-6d38b0784372 53852-0007 HUMAN OTC DRUG Enhance Remedy For Women Agnus Castus, Aletris farinosa, Berberis vulgaris, Caulophyllum thalictroides, Causticum, Ferrum metallicum, Graphites, Ignatia amara, Natrum muriaticum, Onosmodium virginianum, Sepia LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC ALETRIS FARINOSA ROOT; BERBERIS VULGARIS ROOT BARK; CAULOPHYLLUM THALICTROIDES ROOT; CAUSTICUM; CHASTE TREE; GRAPHITE; IRON; ONOSMODIUM VIRGINIANUM WHOLE; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL 53852-0008_b46f7bcf-92b0-4293-9368-68203c4d7a31 53852-0008 HUMAN OTC DRUG FEM Remedy Amyl nitrosum, Calcarea carbonica, Cimicifuga racemosa, Ferrum metallicum, Sanguinaria canadensis, Sepia LIQUID ORAL 20140716 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC AMYL NITRITE; BLACK COHOSH; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL 53852-0009_482be1cf-f0eb-4b47-b715-61cc0fb7119c 53852-0009 HUMAN OTC DRUG Sleep Now Remedy avena sativa, camphora, coffea cruda, cypripedium pubescens, ignatia amara, passiflora incarnata, valeriana officinalis LIQUID ORAL 20100716 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; CAMPHOR (NATURAL); CYPRIPEDIUM PARVIFOLUM ROOT; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS IGNATII SEED; VALERIAN 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 53852-0010_3289cc7f-e6c0-4521-8bb2-24d3e768f006 53852-0010 HUMAN OTC DRUG Lung Remedy Phase 1 Carbo vegetabilis, Bromium, Lobelia inflata, Phosphorus, Silicea LIQUID ORAL 20121029 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC ACTIVATED CHARCOAL; BROMINE; LOBELIA INFLATA; PHOSPHORUS; SILICON DIOXIDE 10; 10; 10; 10; 10 [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL 53859-001_895cadd6-0d78-4adb-a66b-3ea9667cbb00 53859-001 HUMAN OTC DRUG Fresh Up Antiseptic Hand ALCOHOL SPRAY TOPICAL 20121107 OTC MONOGRAPH NOT FINAL part333E G&G Medical Products LLC ALCOHOL 70 mL/100mL 53863-120_dd2e2774-4545-43e7-a423-4c53b97fdfbd 53863-120 HUMAN OTC DRUG Sunscreen Creme SPF 37 Exel Octocrylene,Octinoxate,Octisalate,Oxybenzone,Titanium Dioxide CREAM TOPICAL 20121015 OTC MONOGRAPH NOT FINAL part352 Exelencia Importers Corp OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 5; 5; 3; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 53863-122_d1c1d16d-df75-4200-bb9c-671c457f5b9d 53863-122 HUMAN OTC DRUG Sun Protection Creme SPF 30 PLUS Exel Clarifying Line Octocrylene, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide CREAM TOPICAL 20141209 OTC MONOGRAPH FINAL part352 Exelencia Importers Corp OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 5; 5; 3; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 53877-001_50927003-7f54-4a37-b343-a1160a24f529 53877-001 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION INTRAVENOUS 20091210 NDA NDA820528 Terumo Corporation ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE .275; 2.99; 31.9; 2.22; 26.3 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 53877-001_90e88126-1edd-4dac-b236-d6432c884ef5 53877-001 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION INTRAVENOUS 20091118 NDA NDA820528 Terumo Corporation ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE .275; 2.99; 31.9; 2.22; 26.3 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 53877-001_f23a57e7-32ed-435e-af7f-da0d25476e65 53877-001 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION INTRAVENOUS 20120522 NDA BN820528 Terumo Corporation ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE .275; 2.99; 31.9; 2.22; 26.3 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 53877-001_fbfa4b64-9465-4f99-a1fb-b290c7587724 53877-001 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION INTRAVENOUS 20091214 NDA NDA820528 Terumo Corporation ADENINE; ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE .275; 2.99; 31.9; 2.22; 26.3 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 53877-005_628aff5a-a91d-4214-8b6c-f445984764be 53877-005 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20100113 NDA NDA880217 Terumo Corporation 53877-005_d86e503b-a46d-4efc-ad65-a19d1ad10306 53877-005 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20091215 NDA NDA880217 Terumo Corporation 53877-006_2e75c172-6a12-437d-95fb-31080146b480 53877-006 HUMAN PRESCRIPTION DRUG IMUFLEX WB-RP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Removing Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20100226 NDA NDA880217 Terumo Corporation 53877-007_e29f009a-114f-4158-9445-75d99386a2ec 53877-007 HUMAN PRESCRIPTION DRUG IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20101215 NDA NDA880217 Terumo Corporation 53877-008_01344968-cee8-4c49-99f3-edc437021d10 53877-008 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20100505 NDA NDA880217 Terumo Corporation 53877-008_06ca1877-28a7-4c14-953b-09ee0cfb8fb4 53877-008 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20100505 NDA NDA880217 Terumo Corporation 53877-008_546dbd1c-487f-4e92-a6d0-981e13b2d5f3 53877-008 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20100505 NDA NDA880217 Terumo Corporation 53877-008_bcc81a06-0371-4a3f-bf5f-10e2eec642f5 53877-008 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20100505 NDA NDA880217 Terumo Corporation 53877-009_7cb06826-c997-4cf3-a9be-dc7095a71c0d 53877-009 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System with Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20100505 NDA NDA880217 Terumo Corporation 53877-009_f08634fe-3c3b-4b52-8547-32abce4e8be8 53877-009 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System with Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20100505 NDA NDA880217 Terumo Corporation 53882-001_6e022f69-388e-49e9-867e-78a7e57c8ede 53882-001 HUMAN OTC DRUG Stressa Back and Neck Pain Relieving Menthol CREAM TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part348 Stressa Incorporated MENTHOL 1.25 g/100g 53882-002_11f9d65c-4717-4802-a8d9-921d4006c9ae 53882-002 HUMAN OTC DRUG Stressa Back and Neck Pain Relieving Menthol OIL TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part348 Stressa Incorporated MENTHOL 1 g/93mL 53897-000_af0cc4f4-869b-4190-9c18-fb323160d4ce 53897-000 HUMAN OTC DRUG Clinical Strength MiracleDry Antiperspirant Deodorant AM ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY LIQUID TOPICAL 20121015 OTC MONOGRAPH FINAL part350 Highland Consumer Products ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 18 mg/mL 53897-001_e0852ed1-87f6-4336-a7cc-6ebbafeaacd7 53897-001 HUMAN OTC DRUG Clinical Strength MiracleDry Antiperspirant Deodorant PM ALUMINUM CHLORIDE LIQUID TOPICAL 20121015 OTC MONOGRAPH FINAL part350 Highland Consumer Products ALUMINUM CHLORIDE 12 mg/mL 53942-055_590b3a21-afe7-4395-8cb9-5a4b1147a1f7 53942-055 HUMAN OTC DRUG MARKET BASKET FRESH SCENT Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Demoulas Supermarkets, Inc. BENZALKONIUM CHLORIDE .115 g/1 53942-069_95fbc0fe-3191-444f-8fbd-54af8e67c5a9 53942-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 19890915 OTC MONOGRAPH FINAL part347 Demoulas Supermarmkets PETROLATUM 1 g/g 53942-072_e3b79d90-2e42-4e99-bd13-622877da84a6 53942-072 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20070330 OTC MONOGRAPH NOT FINAL part348 Demoulas Super Markets EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 53942-153_b2c0ffbd-b123-4989-abf9-fb8803eb93a3 53942-153 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Demoulas Super Markets, Inc PYRITHIONE ZINC 1 kg/100L 53942-163_4d14951c-d717-4365-b575-e0a4baeed051 53942-163 HUMAN OTC DRUG Anticavity SODIUM FLUORIDE MOUTHWASH ORAL 20060513 OTC MONOGRAPH FINAL part355 Demoulas Super Markets, Inc. SODIUM FLUORIDE 999.5 mL/100L 53942-210_427c19eb-33e6-4943-a48d-c2b803e0d8eb 53942-210 HUMAN OTC DRUG Advanced Antiseptic Eucalyptol MOUTHWASH ORAL 20100722 OTC MONOGRAPH FINAL part348 Demoulas Super Markets, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 53942-223_e4ab39d7-2c10-4d3a-a964-302488131faa 53942-223 HUMAN OTC DRUG Alcohol Free Antiseptic Cetylpyridiium chloride RINSE ORAL 20120416 OTC MONOGRAPH NOT FINAL part356 Demoulas Super Markets Inc CETYLPYRIDINIUM CHLORIDE .07 mL/100L 53942-243_a6547216-54e4-441b-b4f6-1dd4a28ed25e 53942-243 HUMAN OTC DRUG Handsoap Triclosan LIQUID TOPICAL 20090112 OTC MONOGRAPH NOT FINAL part333A Demoulas Super Markets, Inc TRICLOSAN 1.545 mg/mL 53942-281_4419ee2c-7674-44b5-b565-c8eb9d0a9623 53942-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090130 OTC MONOGRAPH FINAL part358H Demoulas Super Markets, Inc PYRITHIONE ZINC 1 kg/100L 53942-299_5229dd48-d2c7-4ec5-b8c2-9dd0369a6e09 53942-299 HUMAN OTC DRUG Antispetic Cetylpyridinium chloride LIQUID ORAL 20120221 OTC MONOGRAPH NOT FINAL part356 Demoulas Super Markets CETYLPYRIDINIUM CHLORIDE .7 mg/mL 53942-311_10c5ee60-e77a-43e3-a059-1b5c04445594 53942-311 HUMAN OTC DRUG Dandruff PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20090130 OTC MONOGRAPH FINAL part358H Market Basket PYRITHIONE ZINC 1 g/100mL 53942-318_1986b63d-3f53-4928-ab73-ebd9de4a3471 53942-318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 19900715 OTC MONOGRAPH NOT FINAL part356 Demoulas Super Markets EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 53942-326_0f4336a5-e824-4cc7-abd4-c9b75002d9b6 53942-326 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130601 OTC MONOGRAPH NOT FINAL part356 Demoulas Super Markets EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 53942-403_716f223e-c52e-4c3e-b3dc-289f798ec325 53942-403 HUMAN OTC DRUG Hand wash Benzalkonium chloride LIQUID TOPICAL 20140828 OTC MONOGRAPH NOT FINAL part333A Demoulas Super Markets, Inc BENZALKONIUM CHLORIDE 1.3 mg/mL 53942-406_1d6c4554-9e73-4fca-8ae0-8e67e14eeefd 53942-406 HUMAN OTC DRUG Market Basket Cold Sore Treatment Benzalkonium Chloride CREAM TOPICAL 20110719 OTC MONOGRAPH NOT FINAL part333A Demoulas Supermarkets, Inc. BENZALKONIUM CHLORIDE 1.3 mg/g 53942-501_06c8c51f-1f88-4e41-a009-53e02e563792 53942-501 HUMAN OTC DRUG NIGHT-TIME MULTI-SYMPTOM COLD/FLU Original ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20121001 OTC MONOGRAPH NOT FINAL part343 DeMoulas Market Basket ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 53942-502_75ad5ea9-927d-41d2-99b0-0de4d63ba826 53942-502 HUMAN OTC DRUG NIGHT-TIME MULTI-SYMPTOM COLD/FLU Cherry ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20121001 OTC MONOGRAPH NOT FINAL part343 DeMoulas Market Basket ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 53942-503_4cd6fac1-147b-498e-a207-9c89bf1095a8 53942-503 HUMAN OTC DRUG Tussin DM Cough and Chest Congestion DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20121001 OTC MONOGRAPH FINAL part341 DeMoulas Market Basket DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 53942-504_65216a31-1749-47db-921a-7d566764fa3c 53942-504 HUMAN OTC DRUG Tussin CF Multi-Symptom Cold DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20120920 OTC MONOGRAPH FINAL part341 DeMoulas Market Basket DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 53942-505_1933cbf1-e235-40dc-affd-5385334afd95 53942-505 HUMAN OTC DRUG Childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20120911 OTC MONOGRAPH FINAL part336 DeMoulas Market Basket DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 53942-506_417e1ecf-e635-45b8-a3a3-c9456ce8c8ae 53942-506 HUMAN OTC DRUG DAY-TIME Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20120912 OTC MONOGRAPH NOT FINAL part343 DeMoulas Market Basket ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 53942-516_40bf35f1-faa3-454b-bc9a-cda671649908 53942-516 HUMAN OTC DRUG Cold, Flu and Sore Throat Maxium Strength ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20130919 OTC MONOGRAPH FINAL part341 DeMoulas Market Basket ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL 53942-519_5613f28b-d7fd-401a-b221-bef80ba31cfc 53942-519 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20100901 OTC MONOGRAPH FINAL part347 Demoulas Supermarkets, Inc PETROLATUM 1000 mg/100g 53942-522_11544ae5-dac4-44ff-a684-1232fe1acfe1 53942-522 HUMAN OTC DRUG Nighttime Sleep-Aid DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20130919 OTC MONOGRAPH FINAL part338 DeMoulas Market Basket DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 53942-664_afe6b3cb-50af-4c66-ad94-4ecaceecba2f 53942-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19980315 OTC MONOGRAPH NOT FINAL part356 Demoulas Super Markets, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 53942-871_66574240-9611-4dc6-9837-ca5a31ca5c13 53942-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Demoulas Super Markets, Inc HYDROGEN PEROXIDE .3 kg/100L 53943-024_e85c204f-2be9-4650-95d6-65ba5e89f915 53943-024 HUMAN OTC DRUG Extra Strength Pain Relief PM Acetaminophen 500mg Diphenhydramine HCl 25mg TABLET, COATED ORAL 20130620 OTC MONOGRAPH NOT FINAL part343 Discount Drug Mart ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 53943-114_0795d1c0-57ec-4892-850e-56ea7f431112 53943-114 HUMAN OTC DRUG DISCOUNT DRUG MART ANTIBACTERIAL FOAMING FRESH WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140529 OTC MONOGRAPH NOT FINAL part333E DISCOUNT DRUG MART BENZALKONIUM CHLORIDE 1.3 mg/mL 53943-114_a0718b4f-ff7b-415d-a2d5-ed0ec92df963 53943-114 HUMAN OTC DRUG DISCOUNT DRUG MART ANTIBACTERIAL FOAMING FRESH WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140529 OTC MONOGRAPH NOT FINAL part333E DISCOUNT DRUG MART BENZALKONIUM CHLORIDE 1.3 mg/mL 53943-115_f5312ee8-5fef-4c62-af83-0f8ef81bdd53 53943-115 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20130620 ANDA ANDA091237 Discount Drug Mart IBUPROFEN 200 mg/1 53943-210_9fb60617-2293-43a9-bd59-3ea943549d81 53943-210 HUMAN OTC DRUG Advanced Antiseptic Citrus EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL MOUTHWASH ORAL 19910615 OTC MONOGRAPH NOT FINAL part356 Drug Mart EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .042 mL/100L; mL/100L; mL/100L; mL/100L 53943-401_a1e34918-1d74-4eff-a680-80bde3243007 53943-401 HUMAN OTC DRUG IBUPROFEN IMMEDIATE RELEASE IBUPROFEN TABLET, COATED ORAL 20141222 ANDA ANDA079129 Discount Drug Mart IBUPROFEN 200 mg/1 53943-403_baf329a1-cef9-445e-8a16-26976e22f4cc 53943-403 HUMAN OTC DRUG IBUPROFEN IMMEDIATE RELEASE IBUPROFEN TABLET, COATED ORAL 20141222 ANDA ANDA079129 Discount Drug Mart IBUPROFEN 200 mg/1 53943-553_cce3608a-9eaf-4d3f-9ddf-ba46189a80b1 53943-553 HUMAN OTC DRUG DISCOUNT DRUG MART MINT MOUTHWASH CETYLPYRIDINIUM CHLORIDE LIQUID ORAL 20140506 OTC MONOGRAPH NOT FINAL part356 DISCOUNT DRUG MART CETYLPYRIDINIUM CHLORIDE .7 mg/mL 53943-554_85c170c2-92bf-43e8-854d-8ef80d18cdd6 53943-554 HUMAN OTC DRUG DISCOUNT DRUG MART ANTICAVITY FLUORIDE RINSE MINT FLAVOR SODIUM FLUORIDE LIQUID ORAL 20140515 OTC MONOGRAPH FINAL part355 DISCOUNT DRUG MART SODIUM FLUORIDE .5 mg/mL 53943-556_eca41ad5-7d3c-4494-910f-ce0828e20a21 53943-556 HUMAN OTC DRUG DISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140506 OTC MONOGRAPH NOT FINAL part356 DISCOUNT DRUG MART EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 53943-557_7c264e6b-f8f1-4d84-81b4-b38571ee2bc0 53943-557 HUMAN OTC DRUG DISCOUNT DRUG MART BLUE MINT MOUTHWASH EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140506 OTC MONOGRAPH NOT FINAL part356 DISCOUNT DOLLAR MART EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 53943-558_aae6ed14-9cc0-43a3-a399-87206ec32a6d 53943-558 HUMAN OTC DRUG DISCOUNT DRUG MART SPRING MINT MOUTHWASH EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140506 OTC MONOGRAPH NOT FINAL part356 DISCOUNT DRUG MART EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 53943-602_cf4566ce-73e7-411e-b478-29a16de6d40f 53943-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20021202 OTC MONOGRAPH FINAL part334 Discount Drug Mart MAGNESIUM SULFATE 1 g/g 53943-721_6e50a43e-bc72-4540-8c9b-908d01459885 53943-721 HUMAN OTC DRUG DISCOUNT DRUG MART ANTIBACTERIAL CLEAN AND FRESH BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140529 OTC MONOGRAPH NOT FINAL part333E DISCOUNT DRUG MART BENZALKONIUM CHLORIDE 1.3 mg/mL 53943-721_e1755c6c-9000-46d1-8521-154b4a9c29da 53943-721 HUMAN OTC DRUG DISCOUNT DRUG MART ANTIBACTERIAL CLEAN AND FRESH BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140529 OTC MONOGRAPH NOT FINAL part333E DISCOUNT DRUG MART BENZALKONIUM CHLORIDE 1.3 mg/mL 53943-804_574d0584-f121-4a36-8712-e66502edef30 53943-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20101130 OTC MONOGRAPH NOT FINAL part333A Discount Drug Mart ISOPROPYL ALCOHOL .91 mg/mL 53943-826_b6b4be18-2e6e-42c1-8087-de836c8721c1 53943-826 HUMAN OTC DRUG less drowsy motion sickness relief Meclizine Hydrochloride TABLET ORAL 20141201 OTC MONOGRAPH FINAL part336 Discount Drug Mart MECLIZINE HYDROCHLORIDE 25 mg/1 53943-835_0c7435fe-5486-4e7b-af20-a961cff1416f 53943-835 HUMAN OTC DRUG DISCOUNT drug mart FOOD FAIR earwax removal kit CARBAMIDE PEROXIDE SOLUTION TOPICAL 20141127 OTC MONOGRAPH FINAL part344 Discount Drug Mart CARBAMIDE PEROXIDE 65 mg/mL 53950-7007_447135e8-5d2a-4d28-b629-b2d52e2f2c59 53950-7007 HUMAN OTC DRUG Robanda Anti-Aging Hand Avobenzone, Octinoxate, Octisilate and Oxybenzone LOTION TOPICAL 20121102 OTC MONOGRAPH NOT FINAL part352 Robanda International, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 1; 7.5; 5; 6 mg/100mL; mg/100mL; mg/100mL; mg/100mL 53964-001_059d71b4-97c9-4a3a-ac71-75c406442313 53964-001 HUMAN PRESCRIPTION DRUG TEPADINA THIOTEPA INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110405 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE ADIENNE SA THIOTEPA 15 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 53964-002_76e288ae-1805-4041-9042-28167959cfe8 53964-002 HUMAN PRESCRIPTION DRUG TEPADINA THIOTEPA INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110405 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE ADIENNE SA THIOTEPA 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 53975-001_6d627079-20de-4c60-bd6d-d0d0a28da8cc 53975-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20130101 UNAPPROVED MEDICAL GAS Fielden Gas Products, Inc. OXYGEN 99 L/100L 53991-001_dfe612aa-83f2-434d-acfb-7518dfd1a536 53991-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20121024 UNAPPROVED MEDICAL GAS Southern Gas and Supply of Mississippi, Inc. OXYGEN 995 mL/L 53997-100_7368031e-8bdc-4e44-bd74-87b28bcd04e3 53997-100 HUMAN OTC DRUG LANSINOH BABY DIMETHICONE OINTMENT TOPICAL 20110101 OTC MONOGRAPH FINAL part347 Lansinoh Laboratories, Inc. DIMETHICONE; LANOLIN; ZINC OXIDE 4.25; 13.17; 4.675 g/85g; g/85g; g/85g 54005-0001_d542d521-8269-4915-b152-0cd8fbed6690 54005-0001 HUMAN OTC DRUG GRAVI-T Allium Sativum, Althaea Officinalis, Annona Muricata, Capsicum Annum, Carduus Marianus, Curcuma Longa, Decaffeinated Camellia Sinensis LIQUID ORAL 20130806 UNAPPROVED HOMEOPATHIC Infinite Therapies of Sarasota, Inc. ALTHAEA OFFICINALIS ROOT; CAPSICUM; GARLIC; GREEN TEA LEAF; SILYBUM MARIANUM SEED; SOURSOP; TURMERIC 3; 3; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54005-0002_2860f802-f434-4480-bd79-81cf3be10fdd 54005-0002 HUMAN OTC DRUG MALE POWERHOUSE Damiana, Dioscorea Villosa, Ginkgo Biloba, Sabal Serrulata, Testosterone, Withania Somnifera LIQUID ORAL 20130812 UNAPPROVED HOMEOPATHIC Infinite Therapies of Sarasota, Inc. DIOSCOREA VILLOSA TUBER; GINKGO; SAW PALMETTO; TESTOSTERONE; TURNERA DIFFUSA LEAFY TWIG; WITHANIA SOMNIFERA ROOT 3; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54024-000_d3012648-b968-4b4f-9a17-b471be09baba 54024-000 HUMAN OTC DRUG BELLA SCHNEIDER BEAUTY Glow And Go Tinted Moisturizing Sunscreen Broad Spectrum SPF 30 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20121012 OTC MONOGRAPH FINAL part352 BELLA SCHNEIDER BEAUTY LLC OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 75; 25; 66.5 mg/mL; mg/mL; mg/mL 54046-000_11ecc847-8d6e-44f2-89b7-6dede093451f 54046-000 HUMAN OTC DRUG PROTECTOR Alcohol Prep Pad ISOPROPYL ALCOHOL LIQUID TOPICAL 20121128 OTC MONOGRAPH NOT FINAL part333A Baoying County Fukang Medical Appliance Co., Ltd. ISOPROPYL ALCOHOL 700 mg/mL 54046-560_81a45aa5-a500-4ba5-b92f-cd13b002527c 54046-560 HUMAN OTC DRUG Antiseptic Cleansing Wipe Benzalkonium Chloride SWAB TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A Baoying County Fukang Medical Appliance Co., Ltd. BENZALKONIUM CHLORIDE .13 g/100g 54057-304_98e03349-1f16-477f-bc4c-7af484a1f67a 54057-304 HUMAN OTC DRUG Alcohol Free Foam Sanitizer Benzalkonium Chloride SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Afflink, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL 54057-305_b9b5b204-7f07-4428-81d8-1c64fdb4fa42 54057-305 HUMAN OTC DRUG Antimicrobial Foam Tricolsan SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Afflink, Inc. TRICLOSAN 3 mg/mL 54057-524_faeb5c8e-d956-4ad4-a4ef-6f5b5443e97f 54057-524 HUMAN OTC DRUG ANTIMICROBIAL CLEANSER CHLOROXYLENOL SOAP TOPICAL 20131016 OTC MONOGRAPH NOT FINAL part333E AFFLAB, Affiliated Laboratories, a Division of AFFLINK CHLOROXYLENOL 3 g/1000mL 54057-681_1ddfa1ec-845f-4a73-aa5d-a6700991887f 54057-681 HUMAN OTC DRUG Antimicrobial Wipes Citrus Scented BENZALKONIUM CHLORIDE CLOTH TOPICAL 20121105 OTC MONOGRAPH NOT FINAL part333E AFFLABS, Affiliated Laboratories, A Division of AFFLINK BENZALKONIUM CHLORIDE .01417 g/1 54057-682_772aec0b-2f01-4928-a7ed-8cdf2cfe7d92 54057-682 HUMAN OTC DRUG Hand Sanitizer Wipes with Aloe BENZALKONIUM CHLORIDE CLOTH TOPICAL 20121105 OTC MONOGRAPH NOT FINAL part333E AFFLABS, Affiliated Laboratories, A Division of AFFLINK BENZALKONIUM CHLORIDE .0067275 g/1 54061-101_6ee89110-ae7c-4814-a8f7-5cafa703741f 54061-101 HUMAN OTC DRUG Phylorinol Phylorinol LIQUID ORAL 20140305 OTC MONOGRAPH NOT FINAL part356 Schaffer Laboratories PHENOL .25 mg/100mL 54092-003_735f8aae-18a5-4120-a0b7-369af3e58c6a 54092-003 HUMAN PRESCRIPTION DRUG ProAmatine midodrine hydrochloride TABLET ORAL 19960906 NDA NDA019815 Shire US Manufacturing Inc. MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 54092-004_735f8aae-18a5-4120-a0b7-369af3e58c6a 54092-004 HUMAN PRESCRIPTION DRUG ProAmatine midodrine hydrochloride TABLET ORAL 19960906 NDA NDA019815 Shire US Manufacturing Inc. MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 54092-007_735f8aae-18a5-4120-a0b7-369af3e58c6a 54092-007 HUMAN PRESCRIPTION DRUG ProAmatine midodrine hydrochloride TABLET ORAL 20020320 NDA NDA019815 Shire US Manufacturing Inc. MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 54092-063_1700d9c6-f411-49ac-9a3b-9be98122976e 54092-063 HUMAN PRESCRIPTION DRUG Agrylin anagrelide hydrochloride CAPSULE ORAL 19970314 NDA NDA020333 Shire US Manufacturing Inc. ANAGRELIDE HYDROCHLORIDE .5 mg/1 Decreased Platelet Production [PE],Platelet-reducing Agent [EPC],Phosphodiesterase 3 Inhibitors [MoA] 54092-171_0cf9d3b7-1b6d-4b02-a896-00439c05e5dd 54092-171 HUMAN PRESCRIPTION DRUG Carbatrol carbamazepine CAPSULE, EXTENDED RELEASE ORAL 19991222 NDA NDA020712 Shire US Manufacturing Inc. CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 54092-172_0cf9d3b7-1b6d-4b02-a896-00439c05e5dd 54092-172 HUMAN PRESCRIPTION DRUG Carbatrol carbamazepine CAPSULE, EXTENDED RELEASE ORAL 19970930 NDA NDA020712 Shire US Manufacturing Inc. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 54092-173_0cf9d3b7-1b6d-4b02-a896-00439c05e5dd 54092-173 HUMAN PRESCRIPTION DRUG Carbatrol carbamazepine CAPSULE, EXTENDED RELEASE ORAL 19970930 NDA NDA020712 Shire US Manufacturing Inc. CARBAMAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 54092-189_4635a860-fd18-4da6-8b33-3db42a6ec473 54092-189 HUMAN PRESCRIPTION DRUG Pentasa mesalamine CAPSULE ORAL 19930510 NDA NDA020049 Shire US Manufacturing Inc. MESALAMINE 250 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 54092-191_4635a860-fd18-4da6-8b33-3db42a6ec473 54092-191 HUMAN PRESCRIPTION DRUG Pentasa mesalamine CAPSULE ORAL 20040708 NDA NDA020049 Shire US Manufacturing Inc. MESALAMINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 54092-252_b584c160-7f39-4ee5-9cd5-43de059466a8 54092-252 HUMAN PRESCRIPTION DRUG Fosrenol lanthanum carbonate TABLET, CHEWABLE ORAL 20041026 NDA NDA021468 Shire US Manufacturing Inc. LANTHANUM CARBONATE 500 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 54092-253_b584c160-7f39-4ee5-9cd5-43de059466a8 54092-253 HUMAN PRESCRIPTION DRUG Fosrenol lanthanum carbonate TABLET, CHEWABLE ORAL 20051123 NDA NDA021468 Shire US Manufacturing Inc. LANTHANUM CARBONATE 750 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 54092-254_b584c160-7f39-4ee5-9cd5-43de059466a8 54092-254 HUMAN PRESCRIPTION DRUG Fosrenol lanthanum carbonate TABLET, CHEWABLE ORAL 20051123 NDA NDA021468 Shire US Manufacturing Inc. LANTHANUM CARBONATE 1000 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 54092-256_b584c160-7f39-4ee5-9cd5-43de059466a8 54092-256 HUMAN PRESCRIPTION DRUG Fosrenol lanthanum carbonate POWDER ORAL 20140924 NDA NDA204734 Shire US Manufacturing Inc. LANTHANUM CARBONATE 750 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 54092-257_b584c160-7f39-4ee5-9cd5-43de059466a8 54092-257 HUMAN PRESCRIPTION DRUG Fosrenol lanthanum carbonate POWDER ORAL 20140924 NDA NDA204734 Shire US Manufacturing Inc. LANTHANUM CARBONATE 1000 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 54092-381_509d2b73-034f-4ceb-bfea-e99c7e408a9f 54092-381 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20020522 NDA NDA021303 Shire US Manufacturing Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54092-383_509d2b73-034f-4ceb-bfea-e99c7e408a9f 54092-383 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20011011 NDA NDA021303 Shire US Manufacturing Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54092-385_509d2b73-034f-4ceb-bfea-e99c7e408a9f 54092-385 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20020522 NDA NDA021303 Shire US Manufacturing Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54092-387_509d2b73-034f-4ceb-bfea-e99c7e408a9f 54092-387 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20011011 NDA NDA021303 Shire US Manufacturing Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54092-389_509d2b73-034f-4ceb-bfea-e99c7e408a9f 54092-389 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20020522 NDA NDA021303 Shire US Manufacturing Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54092-391_509d2b73-034f-4ceb-bfea-e99c7e408a9f 54092-391 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20011011 NDA NDA021303 Shire US Manufacturing Inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54092-476_f13e39d5-0d9b-4a92-8b4c-00ff78fbdbde 54092-476 HUMAN PRESCRIPTION DRUG Lialda mesalamine TABLET, DELAYED RELEASE ORAL 20070116 NDA NDA022000 Shire US Manufacturing Inc. MESALAMINE 1.2 g/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 54092-513_d87f92d6-394c-4125-8ab4-25d0789ace0a 54092-513 HUMAN PRESCRIPTION DRUG Intuniv guanfacine TABLET, EXTENDED RELEASE ORAL 20090902 NDA NDA022037 Shire US Manufacturing Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54092-515_d87f92d6-394c-4125-8ab4-25d0789ace0a 54092-515 HUMAN PRESCRIPTION DRUG Intuniv guanfacine TABLET, EXTENDED RELEASE ORAL 20090902 NDA NDA022037 Shire US Manufacturing Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54092-517_d87f92d6-394c-4125-8ab4-25d0789ace0a 54092-517 HUMAN PRESCRIPTION DRUG Intuniv guanfacine TABLET, EXTENDED RELEASE ORAL 20090902 NDA NDA022037 Shire US Manufacturing Inc. GUANFACINE HYDROCHLORIDE 3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54092-519_d87f92d6-394c-4125-8ab4-25d0789ace0a 54092-519 HUMAN PRESCRIPTION DRUG Intuniv guanfacine TABLET, EXTENDED RELEASE ORAL 20090902 NDA NDA022037 Shire US Manufacturing Inc. GUANFACINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54092-520_d87f92d6-394c-4125-8ab4-25d0789ace0a 54092-520 HUMAN PRESCRIPTION DRUG Intuniv guanfacine KIT 20090902 NDA NDA022037 Shire US Manufacturing Inc. 54092-700_2e49c4c9-c0e3-4214-9ef0-fa91999af334 54092-700 HUMAN PRESCRIPTION DRUG ELAPRASE idursulfase SOLUTION, CONCENTRATE INTRAVENOUS 20060724 BLA BLA125151 Shire US Manufacturing Inc. IDURSULFASE 6 mg/3mL alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC] 54092-701_d6fdba7c-4d6c-479f-83d9-c24e3c5b7cf4 54092-701 HUMAN PRESCRIPTION DRUG VPRIV velaglucerase alfa INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100226 NDA NDA022575 Shire US Manufacturing Inc. VELAGLUCERASE ALFA 2.5 mg/mL Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC] 54092-702_34091cfa-6b87-4448-927f-9296198e83d5 54092-702 HUMAN PRESCRIPTION DRUG Firazyr icatibant acetate INJECTION, SOLUTION SUBCUTANEOUS 20110825 NDA NDA022150 Shire US Manufacturing Inc. ICATIBANT ACETATE 30 mg/3mL Bradykinin B2 Receptor Antagonist [EPC],Bradykinin B2 Receptor Antagonists [MoA] 54095-111_6dd21e95-eb18-4f04-9099-a8fbc9d10b9f 54095-111 HUMAN OTC DRUG PsorMedicor Premium Skin Care Product COAL TAR OINTMENT TOPICAL 20131111 OTC MONOGRAPH FINAL part358H Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD COAL TAR 2.5 g/100g 54102-000_0e0f03f4-aa33-4f41-89c7-933a6bf5cd2a 54102-000 HUMAN OTC DRUG Q Health Pain Relief Spray MENTHOL LIQUID TOPICAL 20120913 OTC MONOGRAPH FINAL part348 QCAN International Inc. MENTHOL 80 mg/mL 54108-0333_a6de5593-7f3a-424f-9b39-97dc75f50cb6 54108-0333 HUMAN OTC DRUG Evenly Radiant Brightening Day Creme SPF 15 Octinoxate and Zinc Oxide CREAM TOPICAL 20140417 OTC MONOGRAPH NOT FINAL part352 derma e OCTINOXATE; ZINC OXIDE 55; 55 mg/g; mg/g 54111-111_7ad16cb1-e20a-46a3-9d2b-b8d1fcef5d9e 54111-111 HUMAN OTC DRUG BRODA Acne Spa SALICYLIC ACID GEL TOPICAL 20131001 OTC MONOGRAPH FINAL part333D Bentley Laboratories, LLC SALICYLIC ACID 2 g/100g 54111-112_797d39b8-1fda-451f-9e74-19f538a6ea42 54111-112 HUMAN OTC DRUG BRODA Acne SALICYLIC ACID GEL TOPICAL 20131029 OTC MONOGRAPH FINAL part333D Bentley Laboratories, LLC SALICYLIC ACID .4 g/20g 54111-113_26bf2ef8-a754-4f7f-a1e0-92cc16930c93 54111-113 HUMAN OTC DRUG YES to coconut ALLANTOIN CREAM TOPICAL 20140505 OTC MONOGRAPH FINAL part347 Bentley Laboratories, LLC ALLANTOIN .425 g/85mL 54111-114_1f1a0422-8193-4735-b91b-623904605b7f 54111-114 HUMAN OTC DRUG Yes to tomatoes SALICYLIC ACID LIQUID TOPICAL 20140904 OTC MONOGRAPH FINAL part333D Bentley Laboratories, LLC SALICYLIC ACID 5.3 g/265mL 54111-205_833c75be-f5d4-4672-a8fe-f8e51b25078e 54111-205 HUMAN OTC DRUG Hair Regrow 5% Minoxidil Topical Solution SOLUTION TOPICAL 20040824 ANDA ANDA076239 Bentley Laboratories, LLC MINOXIDIL 50 mg/mL 54118-5152_9e6cb155-bd12-4015-a549-2f2508d0134a 54118-5152 HUMAN OTC DRUG Immune Support System Penicillium notatum, Penicillium frequentans, Aconitum napellus, Colloidal silver SPRAY NASAL 20121004 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. ACONITUM NAPELLUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM; SILVER 4; 4; 4; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 54118-7132_eaac1277-a56b-43a8-bffd-a038882b754f 54118-7132 HUMAN OTC DRUG Oral HCG Homeopathic Hypothalamus, Pituitary, Hepar Suis, Methyl B12 SOLUTION/ DROPS ORAL 20140305 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE; BOS TAURUS HYPOTHALAMUS; BOS TAURUS PITUITARY GLAND; GAMBOGE; GENTIANA LUTEA ROOT; GLUCAGON; GONADOTROPHIN, CHORIONIC; GRAPHITE; INSULIN HUMAN; LACTIC ACID, L-; METHYLCOBALAMIN; PHYTOLACCA AMERICANA ROOT; PORK KIDNEY; PORK LIVER; SEMECARPUS ANACARDIUM JUICE; STRYCHNOS NUX-VOMICA SEED 30; 30; 6; 6; 12; 5; 30; 12; 12; 30; 3; 8; 3; 8; 8; 15; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL 54118-7141_20983373-09f1-4a02-ae05-44fc0b377d25 54118-7141 HUMAN OTC DRUG GlycoPan Tox Argentium nitricum, Kali carbonicum, Glycirrhiza glabra SOLUTION/ DROPS ORAL 20130201 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. ADENOSINE TRIPHOSPHATE; BOS TAURUS ADRENAL GLAND; BOS TAURUS MESENCHYME; BOS TAURUS PITUITARY GLAND; CHOLESTEROL; CHROMIUM; FENUGREEK SEED; GLYCYRRHIZA GLABRA; GYMNEMA SYLVESTRE LEAF; KIDNEY BEAN; LACTIC ACID, DL-; LYCOPODIUM CLAVATUM SPORE; MAMMAL LIVER; PHOSPHORIC ACID; POTASSIUM CARBONATE; RHUS AROMATICA ROOT BARK; SELENIUM; SILVER NITRATE; SKIM MILK; SUCROSE; SUS SCROFA PANCREAS; SYZYGIUM CUMINI SEED; THYROID, UNSPECIFIED; URANYL NITRATE HEXAHYDRATE; ZINC 5; 6; 6; 6; 7; 3; 3; 1; 1; 1; 3; 30; 6; 4; 9; 3; 9; 9; 6; 6; 6; 1; 6; 30; 9 [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL 54118-7188_6cf55f5e-8527-44d5-a70e-4b57ba6e28a8 54118-7188 HUMAN OTC DRUG HCG Plus Human Chorionic Gonadotropin (HCG), Garcinia Cambogia, Hypothalamus SOLUTION/ DROPS ORAL 20140516 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. ACETYLCARNITINE; AMERICAN GINSENG; ARGININE; CALCIUM ARSENATE; FUCUS VESICULOSUS; GLUTAMIC ACID; GONADOTROPHIN, CHORIONIC; LEUCINE; ORNITHINE 3; 6; 3; 6; 6; 6; 12; 6; 12 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL 54118-7196_a155c3ab-8ab1-42be-b622-adfeb4aecabe 54118-7196 HUMAN OTC DRUG Oral hCG Activator Hypothalamus, Hepar Suis, Methyl B12, Renal Suis, Gambogia, Graphites SOLUTION/ DROPS ORAL 20140305 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE; ARGININE; BOS TAURUS HYPOTHALAMUS; BOS TAURUS PITUITARY GLAND; GAMBOGE; GENTIANA LUTEA ROOT; GLUCAGON; GRAPHITE; INSULIN PORK; LACTIC ACID, L-; LEVOCARNITINE; METHYLCOBALAMIN; PHENYLALANINE; PHYTOLACCA AMERICANA ROOT; PORK KIDNEY; PORK LIVER; SEMECARPUS ANACARDIUM JUICE; STRYCHNOS NUX-VOMICA SEED; THYROID, UNSPECIFIED; TRYPTOPHAN 30; 30; 12; 6; 6; 12; 5; 30; 12; 30; 3; 12; 8; 12; 3; 8; 8; 15; 12; 3; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL 54118-7199_0cca253d-60c2-4d31-b7d6-0c296e941f9a 54118-7199 HUMAN OTC DRUG Immune Support System Penicillium Notatum, Penicillium Frequentans, Aconitum Napellus, Ferrum Phosphoricum TABLET ORAL 20121001 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. ACONITUM NAPELLUS; FERROSOFERRIC PHOSPHATE; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM 4; 6; 4; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54118-7232_dc0a2e1f-4ae8-4c0f-8f12-a64b80c30789 54118-7232 HUMAN OTC DRUG HCG Plus Human Chorionic Gonadotropin (HCG), Garcinia Cambogia, Hypothalamus SOLUTION/ DROPS ORAL 20140405 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. 7-KETO-DEHYDROEPIANDROSTERONE; AMMONIUM CARBONATE; BEEF KIDNEY; BOS TAURUS BRAIN; BOS TAURUS HYPOTHALAMUS; BOS TAURUS PITUITARY GLAND; CALCIUM CARBONATE; CALCIUM FLUORIDE; FUCUS VESICULOSUS; GARCINIA CAMBOGIA FRUIT; GELSEMIUM SEMPERVIRENS WHOLE; GLUCAGON; GONADOTROPHIN, CHORIONIC; GRAPHITE; INSULIN HUMAN; LACTIC ACID, L-; METHYLCOBALAMIN; PHYTOLACCA AMERICANA ROOT; PORK LIVER; PROTEUS INCONSTANS; SEMECARPUS ANACARDIUM JUICE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; THYROID, UNSPECIFIED; TRIPE 30; 6; 8; 8; 6; 12; 12; 6; 3; 12; 12; 30; 12; 12; 30; 30; 8; 12; 8; 30; 6; 12; 8; 12; 8 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL 54118-7967_1fedc888-9dc1-4971-baa0-46086be2b64c 54118-7967 HUMAN OTC DRUG Lymph 1 Acute Adrenal, Apis mellifica SOLUTION/ DROPS ORAL 20110228 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. ADENOSINE TRIPHOSPHATE; APIS MELLIFERA; ARANEUS DIADEMATUS; ATROPA BELLADONNA; BOS TAURUS ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; BOS TAURUS PITUITARY GLAND; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; FUMARIA OFFICINALIS FLOWERING TOP; GALIUM APARINE; GRAPHITE; LACHESIS MUTA VENOM; MARITIME PINE; MERCUROUS IODIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM IODIDE; SCROPHULARIA NODOSA; SULFUR; THYROID, BOVINE; TOXICODENDRON PUBESCENS LEAF; UNCARIA TOMENTOSA LEAF; VESPA CRABRO; VIROLA SEBIFERA RESIN 4; 3; 9; 6; 3; 3; 3; 6; 1; 6; 9; 6; 12; 6; 9; 9; 12; 2; 3; 9; 12; 6; 12; 3; 12; 9 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL 54118-7972_9baf9418-5173-409f-a624-eaee0c2fdef3 54118-7972 HUMAN OTC DRUG Ultimate Rescue Cherry Plum, Clematis, Impatiens, Rock rose, Star of Bethlehem, ATP, Pineal, thymus SOLUTION/ DROPS ORAL 20110228 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. ADENOSINE TRIPHOSPHATE; BOS TAURUS PINEAL GLAND; BOS TAURUS THYMUS; CHERRY PLUM; CISTUS INCANUS WHOLE; CLEMATIS CHINENSIS ROOT; IMPATIENS BALSAMINA LEAF; ORNITHOGALUM UMBELLATUM 5; 6; 6; 30; 30; 30; 30; 30 [hp_X]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL 54118-7976_f294fc3e-4d48-4774-a032-aac88ccd9edc 54118-7976 HUMAN OTC DRUG Aller-Tox 1 Acetaldehyde, Adrenal, Argentum Nitricum SOLUTION/ DROPS ORAL 20121121 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. ACETALDEHYDE; ADENOSINE TRIPHOSPHATE; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS ADRENAL GLAND; BOS TAURUS MESENCHYME; CORTICOTROPIN; CORTISONE; GALLIC ACID MONOHYDRATE; HISTAMINE; HYALURONIDASE; HYDRANGEA ARBORESCENS ROOT; INTERFERON BETA-1A; LYCOPODIUM CLAVATUM SPORE; MAMMAL LIVER; SEROTONIN; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED 6; 5; 6; 30; 3; 6; 12; 6; 6; 6; 6; 6; 6; 12; 5; 6; 6; 12 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL 54118-7977_36da272b-ede3-4282-b0db-feebf6e9ccad 54118-7977 HUMAN OTC DRUG Aller - Tox 11 Adrenal, Allium cepa, Ambrosia artemisiaefolia SOLUTION/ DROPS ORAL 20121128 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc ADENOSINE TRIPHOSPHATE; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; BEEF LIVER; BEEF LUNG; BOS TAURUS ADRENAL GLAND; BOS TAURUS MESENCHYME; COUMARIN; EUPHRASIA STRICTA; HISTAMINE; HYALURONIDASE; MENADIONE; ONION; PHOSPHORUS; PIPERINE; PULSATILLA PRATENSIS; RUTIN; SCHOENOCAULON OFFICINALE SEED; SULFUR 5; 3; 12; 5; 3; 3; 6; 6; 3; 6; 9; 5; 3; 12; 5; 12; 5; 3; 12 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL 54118-7978_7f169fa8-7925-4baa-8fe1-644544b2a3a7 54118-7978 HUMAN OTC DRUG Amoeba Tox Adrenal, Amoeba nosodes, Artemisia absinthium SOLUTION/ DROPS ORAL 20121128 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc ADENOSINE TRIPHOSPHATE; ALPINE STRAWBERRY; BAPTISIA TINCTORIA; BOS TAURUS ADRENAL GLAND; BOS TAURUS MESENCHYME; BOS TAURUS SPLEEN; CAJUPUT OIL; CAPSICUM; CEANOTHUS AMERICANUS LEAF; CHELONE GLABRA; CINCHONA OFFICINALIS BARK; ENTAMOEBA HISTOLYTICA; GENTIANA LUTEA ROOT; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MAMMAL LIVER; QUASSIA AMARA WOOD; SENNA LEAF; STRYCHNOS NUX-VOMICA SEED; WORMWOOD 5; 3; 3; 6; 6; 5; 1; 3; 6; 3; 12; 30; 6; 3; 12; 5; 3; 3; 12; 6 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_Q]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL 54118-7979_4946546b-379a-4269-975f-2d96cf2b13b9 54118-7979 HUMAN OTC DRUG Bacteria Tox Adrenal, ATP, Bac nosode, Belladonna SOLUTION/ DROPS ORAL 20121130 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. ADENOSINE TRIPHOSPHATE; ATROPA BELLADONNA; BEEF LIVER; BORRELIA BURGDORFERI; BOS TAURUS ADRENAL GLAND; BOS TAURUS MESENCHYME; BOS TAURUS SPLEEN; CROTALUS HORRIDUS HORRIDUS VENOM; GOLDENSEAL; HUMAN THYMUS; HYPERICUM PERFORATUM; LOMATIUM DISSECTUM ROOT; MYCOBACTERIUM TUBERCULOSIS; MYRRH; NASTURTIUM OFFICINALE; PHOSPHORUS; TABEBUIA IMPETIGINOSA BARK 5; 6; 3; 12; 3; 6; 5; 12; 3; 5; 12; 3; 12; 3; 3; 12; 3 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL 54118-7981_f2b2191b-d215-4ae4-b8d8-004ecec8ee83 54118-7981 HUMAN OTC DRUG Chem - Tox Adrenal, Arctium lappa, ATP, Belladonna, Chemical isodes SOLUTION/ DROPS ORAL 20121130 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. ADENOSINE TRIPHOSPHATE; ARCTIUM LAPPA WHOLE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BEEF KIDNEY; BEEF LIVER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; ELYMUS REPENS ROOT; FRANGULA PURSHIANA BARK; LICORICE; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PHOSPHORIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; STRYCHNOS NUX-VOMICA SEED; THYROID, BOVINE; TRIFOLIUM PRATENSE FLOWER 5; 3; 12; 12; 3; 3; 5; 3; 6; 3; 3; 3; 12; 6; 6; 12; 3; 12; 5; 3 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL 54118-7990_a6097ed7-2469-4dbf-b3d5-acf11dda0470 54118-7990 HUMAN OTC DRUG Gyne - Tox Adrenal, Angelica Atropurpurea, Boricum Acidum, ATP SOLUTION/ DROPS ORAL 20121219 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. ADENOSINE TRIPHOSPHATE; ANEMONE NEMOROSA; ANGELICA ATROPURPUREA ROOT; BLACK COHOSH; BORIC ACID; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS OVARY; BOS TAURUS PLACENTA; BOS TAURUS UTERUS; CANDIDA ALBICANS; DELPHINIUM STAPHISAGRIA SEED; ESTRONE; GONORRHEAL URETHRAL SECRETION HUMAN; MERCURIUS SOLUBILIS; SCABIES LESION LYSATE (HUMAN); SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TREPONEMIC SKIN CANKER HUMAN; WOOD CREOSOTE 5; 12; 3; 3; 12; 6; 6; 6; 5; 5; 5; 6; 12; 30; 30; 12; 30; 12; 12; 6; 30; 12 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL 54118-7993_838c7ad0-cfda-4c83-b035-28b17bad40d3 54118-7993 HUMAN OTC DRUG HZ - Tox Arsenicum album, Asclepias tuberus, ATP SOLUTION/ DROPS ORAL 20121221 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc ADENOSINE TRIPHOSPHATE; ARSENIC; ASCLEPIAS TUBEROSA FLOWERING TOP; BAPTISIA TINCTORIA; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFATE ANHYDROUS; CAT'S CLAW; DAPHNE MEZEREUM BARK; HUMAN HERPESVIRUS 5; LOMATIUM DISSECTUM ROOT; RANUNCULUS BULBOSUS; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAF; THYROID, BOVINE; TOXICODENDRON PUBESCENS LEAF 5; 3; 3; 3; 3; 6; 3; 5; 6; 1; 3; 30; 3; 3; 12; 12; 5; 6 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; 1/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL 54123-114_85a25bc3-f251-400d-a106-bf389a592b0b 54123-114 HUMAN PRESCRIPTION DRUG Zubsolv buprenorphine hydrochloride and naloxone hydrochloride TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20141211 NDA NDA204242 Orexo US, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 11.4; 2.9 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 54123-914_85a25bc3-f251-400d-a106-bf389a592b0b 54123-914 HUMAN PRESCRIPTION DRUG Zubsolv buprenorphine hydrochloride and naloxone hydrochloride TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20130704 NDA NDA204242 Orexo US, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 1.4; .36 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 54123-957_85a25bc3-f251-400d-a106-bf389a592b0b 54123-957 HUMAN PRESCRIPTION DRUG Zubsolv buprenorphine hydrochloride and naloxone hydrochloride TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20130704 NDA NDA204242 Orexo US, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 5.7; 1.4 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 54123-986_85a25bc3-f251-400d-a106-bf389a592b0b 54123-986 HUMAN PRESCRIPTION DRUG Zubsolv buprenorphine hydrochloride and naloxone hydrochloride TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20141211 NDA NDA204242 Orexo US, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8.6; 2.1 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 54131-001_77e6a1f0-9841-435e-b35d-71cf148a04c6 54131-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19630101 UNAPPROVED MEDICAL GAS Del Rio Welders Equipment, Inc. OXYGEN 99 L/100L 54136-030_0e6f7207-9085-4a0c-9da8-5611ba1c1cb6 54136-030 HUMAN OTC DRUG Acure Mineral Protection Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20121125 OTC MONOGRAPH NOT FINAL part352 Better Planet Brands TITANIUM DIOXIDE; ZINC OXIDE 9; 3 g/100g; g/100g 54144-001_461b41a1-bb02-4582-9aa8-7846dcbf3c05 54144-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS Mon HealthCare OXYGEN 990 mL/L 54146-0001_190f2386-07ad-478c-8b95-89517403bf0c 54146-0001 HUMAN OTC DRUG Flu-Cold Echinacea, Arsenicum Album, Baptisia Tinctoria, Eupatorium Perfoliatum, Gelsemium Sempervirens, Lycopodium Clavatum LIQUID ORAL 20130430 UNAPPROVED HOMEOPATHIC Natural Wonders ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 12; 12; 3; 12; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54151-101_78c157ec-598d-4916-9cf2-7e9619f26ca0 54151-101 HUMAN OTC DRUG Ingenue Zinc Oxide CREAM TOPICAL 20120615 OTC MONOGRAPH NOT FINAL part352 Ingenue, LLC ZINC OXIDE 14.5 mg/mL 54157-101_aa24120e-2711-4e51-ae20-c6ae96dadb79 54157-101 HUMAN OTC DRUG MegaFresh Antibacterial Deodorant Triclocarban SOAP TOPICAL 20130304 OTC MONOGRAPH NOT FINAL part333A American Amenities, Inc. TRICLOCARBAN .3 g/100g 54157-102_a2416d56-d014-4b3a-9d51-ab60e21368d7 54157-102 HUMAN OTC DRUG MegaFresh SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20131104 OTC MONOGRAPH FINAL part355 American Amenities, Inc. SODIUM FLUORIDE .1 g/100g 54157-103_6df27c76-ab9c-4436-a010-bf0443c527de 54157-103 HUMAN OTC DRUG MegaFresh Fluoride Tooth SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20131104 OTC MONOGRAPH FINAL part355 American Amenities, Inc. SODIUM MONOFLUOROPHOSPHATE .1 g/100g 54157-104_1202edcc-88aa-413c-9f77-f05d785434a4 54157-104 HUMAN OTC DRUG MegaFresh SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20140511 OTC MONOGRAPH FINAL part355 American Amenities, Inc. SODIUM FLUORIDE .15 g/100g 54157-105_c3a3082d-477f-4bda-93a1-8421efdf6124 54157-105 HUMAN OTC DRUG MegaFresh Hand Sanitizer ALCOHOL LIQUID TOPICAL 20140816 OTC MONOGRAPH NOT FINAL part333E American Amenities, Inc. ALCOHOL 62 mL/100mL 54157-106_358431b6-e659-4394-bdb7-f81c1fce71d6 54157-106 HUMAN OTC DRUG MegaFresh Clear Gel Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20141106 OTC MONOGRAPH FINAL part350 American Amenities, Inc. ALUMINUM CHLOROHYDRATE 4.5 g/100mL 54162-000_c08b7ed9-a276-42bc-9c47-53554d2e1c60 54162-000 HUMAN OTC DRUG Vitamin A and D Vitamin A and D OINTMENT TOPICAL 20120416 OTC MONOGRAPH NOT FINAL part349 Geritrex Corp. PETROLATUM 55 g/100g 54162-004_704508f0-eba8-4830-980e-8e3252da474b 54162-004 HUMAN OTC DRUG Hemorrhoidal Hygiene pads witch hazel RINSE RECTAL 20120323 OTC MONOGRAPH NOT FINAL part347 Geritrex Corp. WITCH HAZEL 50 mL/100mL 54162-004_cc9dc260-c536-4243-ae51-20268281f1e4 54162-004 HUMAN OTC DRUG Hemorrhoidal Hygiene pads witch hazel RINSE RECTAL 20120302 OTC MONOGRAPH NOT FINAL part347 Geritrex Corp. WITCH HAZEL 50 mL/100mL 54162-006_63a99d4b-5b19-41c8-88d8-6582011e4ec7 54162-006 HUMAN OTC DRUG BISACODYL BISACODYL SUPPOSITORY RECTAL 20120223 OTC MONOGRAPH NOT FINAL part334 Geritrex Corp. BISACODYL .01 g/2g 54162-006_8efe13b6-db32-4e53-a498-5015d6853119 54162-006 HUMAN OTC DRUG BISACODYL BISACODYL SUPPOSITORY RECTAL 20120224 OTC MONOGRAPH NOT FINAL part334 Geritrex Corp. BISACODYL .01 g/2g 54162-009_58d89a8c-ce58-4ab3-aa58-0cc10b92d7c4 54162-009 HUMAN OTC DRUG Berri-Freez MENTHOL GEL TOPICAL 20121212 OTC MONOGRAPH NOT FINAL part348 Geritrex Corp MENTHOL 4.5 g/100g 54162-010_78d82af0-9029-4133-99c3-030215ad43ff 54162-010 HUMAN OTC DRUG Asper-Flex Cream Trolamine Salicylate CREAM TOPICAL 20111207 OTC MONOGRAPH NOT FINAL part352 Geritrex Corp. TROLAMINE SALICYLATE 10 g/100g 54162-011_ed16f680-ea91-4153-950e-75e51d8871ec 54162-011 HUMAN OTC DRUG Dibucaine Dibucaine OINTMENT TOPICAL 20140106 OTC MONOGRAPH FINAL part346 GERITREX CORP DIBUCAINE 1 g/100g 54162-015_44f1708c-4157-4c4d-9c04-26d419be7083 54162-015 HUMAN OTC DRUG GRx HiCort HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 20131112 OTC MONOGRAPH NOT FINAL part348 GERITREX CORP HYDROCORTISONE ACETATE .025 g/2g 54162-017_a72cdfe0-b6f1-4832-9811-89962f56a668 54162-017 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20140515 OTC MONOGRAPH FINAL part333B GERITREX CORP BACITRACIN ZINC 500 [iU]/g 54162-018_ce329877-f502-4829-8609-553bc3259aa1 54162-018 HUMAN OTC DRUG CLOTRIMAZOLE CLOTRIMAZOLE CREAM TOPICAL 20140729 OTC MONOGRAPH FINAL part333C Geritrex Corp CLOTRIMAZOLE 1 g/100g 54162-019_cce3257a-9f4d-4f34-a79f-2ac4e518742c 54162-019 HUMAN OTC DRUG Benzoyl Peroxide Benzoyl Peroxide GEL TOPICAL 20140109 OTC MONOGRAPH FINAL part333D GERITREX CORP BENZOYL PEROXIDE 10 g/100g 54162-045_5a2ce02c-f1fe-47e5-97ab-1b9ecbe45151 54162-045 HUMAN OTC DRUG HEMORRHOIDAL HEMORRHOIDAL SUPPOSITORY RECTAL 20120229 OTC MONOGRAPH FINAL part346 Geritrex Corp. COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 85.5; .25 g/100g; g/100g 54162-107_99125a34-3368-49d7-b147-819b7d5dae3c 54162-107 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20140723 OTC MONOGRAPH FINAL part333B GERITREX CORP BACITRACIN ZINC 500 [iU]/g 54162-175_28ff90e2-f6b8-49bd-b766-4987e3eea14a 54162-175 HUMAN OTC DRUG Mineral oil Mineral oil OIL RECTAL 20140501 OTC MONOGRAPH NOT FINAL part334 GERITREX CORP MINERAL OIL 100 g/100g 54162-221_4125d0cc-d84e-484d-a7ba-d986739bdace 54162-221 HUMAN OTC DRUG Dermadrox Aluminum Hydroxide OINTMENT TOPICAL 20130130 OTC MONOGRAPH NOT FINAL part346 GERITREX CORP ALUMINUM HYDROXIDE 1.2 g/100g 54162-221_a95b6135-6f60-4abf-9837-9ce1305cf866 54162-221 HUMAN OTC DRUG Dermadrox Aluminum Hydroxide OINTMENT TOPICAL 20131015 OTC MONOGRAPH FINAL part331 GERITREX CORP ALUMINUM HYDROXIDE 1.2 g/100g 54162-268_c5de7b12-7ebb-4030-87fc-7f0df2442ab0 54162-268 HUMAN OTC DRUG GRx Dyne Scrub POVIDONE-IODINE SOLUTION TOPICAL 20120703 OTC MONOGRAPH NOT FINAL part333A Geritrex Corp. POVIDONE-IODINE 7500 mg/100mL 54162-269_75ffc2d3-b014-4e28-a7ae-76b61646f8e1 54162-269 HUMAN OTC DRUG GRx Dyne Povidone Iodine SOLUTION TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part333A Geritrex Corp. POVIDONE-IODINE 10 mL/100mL 54162-269_f20e255c-14cc-4eab-a72b-90000cc0a45b 54162-269 HUMAN OTC DRUG GRx Dyne Povidone Iodine SOLUTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part333A Geritrex Corp. POVIDONE-IODINE 10 mL/100mL 54162-500_60b5bef3-7508-49fc-b5cb-947d259e540c 54162-500 HUMAN OTC DRUG Hydrophor Petrolatum OINTMENT TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part349 Geritrex Corp. PETROLATUM 42 g/100g 54162-500_d25020fe-7bab-427e-b466-6a582554b2bf 54162-500 HUMAN OTC DRUG Hydrophor Petrolatum OINTMENT TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part349 Geritrex Corp. PETROLATUM 42 g/100g 54162-540_c2b7282b-6a7c-4344-9694-a72ccc386c36 54162-540 HUMAN OTC DRUG KERATEK MENTHOL, METHYL SALICYLATE GEL TOPICAL 20131021 OTC MONOGRAPH NOT FINAL part348 GERITREX CORP MENTHOL; METHYL SALICYLATE 16; 28 g/100g; g/100g 54162-550_f00225c7-8b48-4efb-a139-66bc44b56af9 54162-550 HUMAN OTC DRUG Men-Phor Menthol, Camphor LOTION TOPICAL 20111214 OTC MONOGRAPH NOT FINAL part356 Geritrex Corp. CAMPHOR (SYNTHETIC); MENTHOL .5; .5 mL/100mL; mL/100mL 54162-555_60a6f1e6-b5fe-4a75-8f5c-1b3334c40325 54162-555 HUMAN OTC DRUG Analgesic Balm Analgesic Balm OINTMENT ENTERAL 20120309 OTC MONOGRAPH NOT FINAL part348 Geritrex Corp. MENTHOL; METHYL SALICYLATE 6; 14 g/100g; g/100g 54162-597_f54a58e8-af1a-4f63-bc5a-df39cf2b7a95 54162-597 HUMAN OTC DRUG White Petrolatum White Petrolatum OINTMENT TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part349 Geritrex Corp. PETROLATUM 100 g/100g 54162-925_2020e17e-7b52-4104-827c-045bde3c7e04 54162-925 HUMAN OTC DRUG Benz O Sthetic Benzocaine SPRAY TOPICAL 20120213 OTC MONOGRAPH NOT FINAL part348 Geritrex Corp. BENZOCAINE 20 mL/100mL 54162-926_d5d5e15e-ffcf-40ef-b73b-2325625b6328 54162-926 HUMAN OTC DRUG Benz O Sthetic Benzocaine GEL TOPICAL 20120126 OTC MONOGRAPH NOT FINAL part356 Geritrex Corp. BENZOCAINE 20 g/100g 54170-100_6ecd6325-e34c-4b79-b956-91ad98544b2f 54170-100 HUMAN OTC DRUG NANOMIX NANO CLEAN Witch hazel SOAP TOPICAL 20120901 OTC MONOGRAPH FINAL part347 NANOPOLY CO., LTD. WITCH HAZEL .001 g/100g 54170-110_710ea658-8254-49a4-97c7-434f8f8769bb 54170-110 HUMAN OTC DRUG NANOMIX BODY CARE Dimethicone LOTION TOPICAL 20130601 OTC MONOGRAPH FINAL part347 NANOPOLY CO., LTD. DIMETHICONE 4.8 mg/400mL 54170-120_0462ccf8-8bcc-494d-bab5-55821a082bc1 54170-120 HUMAN OTC DRUG NANOMIX NANO CLEAN Skin Protectant Antibacterial Function Allantoin SOAP TOPICAL 20130701 OTC MONOGRAPH FINAL part347 NANOPOLY CO., LTD. ALLANTOIN .6 g/100g 54170-130_159a304b-2122-4957-acb6-8bec2d094f0b 54170-130 HUMAN OTC DRUG SEUK Allantoin SOAP TOPICAL 20140201 OTC MONOGRAPH FINAL part347 NANOPOLY CO., LTD. ALLANTOIN .6 g/100g 54181-001_4590b307-7205-4547-9fd2-7665b788566f 54181-001 HUMAN OTC DRUG GUINOT Skin Defense SPF 15 Face OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20130311 OTC MONOGRAPH NOT FINAL part352 Guinot SAS OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 60; 50; 40; 11 mg/mL; mg/mL; mg/mL; mg/mL 54181-002_03a883f8-8fea-480b-a524-e4ccbc0d0ff2 54181-002 HUMAN OTC DRUG GUINOT Ultra UV Sunscreen High Protection Sun For The Face SPF 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130311 OTC MONOGRAPH NOT FINAL part352 Guinot SAS TITANIUM DIOXIDE; ZINC OXIDE 96; 143 mg/mL; mg/mL 54181-003_fe1dad0f-6dae-436d-9c77-3a3688a5c2ac 54181-003 HUMAN OTC DRUG GUINOT Ultra UV Sunscreen High Protection Sun Cream for the face and body SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20140102 OTC MONOGRAPH NOT FINAL part352 GUINOT SAS AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 2.8 mg/mL; mg/mL; mg/mL; mg/mL 54181-004_02f8ab3e-ca54-42f0-8bd3-6d295e0c3449 54181-004 HUMAN OTC DRUG GUINOT Large Defense uv Medium protection Sunscreen for the body SPF 20 AVOBENZONE, HOMOSALATE, OCTOCRYLENE LOTION TOPICAL 20140102 OTC MONOGRAPH NOT FINAL part352 Guinot SAS AVOBENZONE; HOMOSALATE; OCTOCRYLENE 29; 120; 27 mg/mL; mg/mL; mg/mL 54182-001_161a374b-5a8b-4a1c-98ca-ce250c85c76f 54182-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140919 UNAPPROVED MEDICAL GAS HRC Healthcare LLC OXYGEN 99 L/100L 54194-268_166348ec-f7f7-419b-bdee-0a62e73d948d 54194-268 HUMAN OTC DRUG ariSulfur Acne Treatment Sulfur SOAP TOPICAL 20130528 OTC MONOGRAPH FINAL part333D A+Plus Medical Center Limited SULFUR 10 g/100g 54202-001_a891d816-59d5-4f65-8314-c7c4ce8b5ec6 54202-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS All Saints Home Medical OXYGEN 99 L/100L 54218-400_490a66e9-8acb-4a1f-bc61-96d0354ce226 54218-400 HUMAN PRESCRIPTION DRUG AIR COMPRESSED AIR COMPRESSED (MEDICAL AIR USP) GAS RESPIRATORY (INHALATION) 19700101 UNAPPROVED MEDICAL GAS United States Welding, Inc. OXYGEN 20 L/100L 54218-500_9db6566a-cd15-4962-a266-15623a448d4d 54218-500 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19700101 UNAPPROVED MEDICAL GAS United States Welding, Inc. OXYGEN 99 L/100L 54218-600_337a1444-9b21-406f-86de-a299652192f6 54218-600 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19700101 UNAPPROVED MEDICAL GAS United States Welding, Inc. NITROGEN 99 L/100L 54218-800_6c87395f-075a-4c60-a28d-b075d00a3644 54218-800 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19700101 UNAPPROVED MEDICAL GAS United States Welding, Inc. NITROUS OXIDE 99 kg/100kg 54230-356_ed0737fc-eb28-4b0b-b9b4-ac368ebe4bb9 54230-356 HUMAN OTC DRUG Celadrin Joint and Muscle Pain Relieving Menthol CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part348 Factors Group of Nutritional Products MENTHOL 12.5 mg/g 54235-204_3a7bcc23-ab3d-4cfd-a50b-6a53cd8cdb37 54235-204 HUMAN OTC DRUG Protectyl soleil moisturizing sunscreen lotion high protection spf 30 Titanium Dioxide, Octinoxate and Octocrylene CREAM TOPICAL 20070501 OTC MONOGRAPH FINAL part352 Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 7; 8.4 mL/100mL; mL/100mL; mL/100mL 54235-205_eb6995ae-7264-4fad-8a61-b15109f35c96 54235-205 HUMAN OTC DRUG FRAICHEUR VERVEINE ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20080701 OTC MONOGRAPH FINAL part350 Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL 54235-206_1d956d33-7cdc-4c7d-8eea-20c418778f97 54235-206 HUMAN OTC DRUG FRAICHEUR CEDRE BLEU ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20081001 OTC MONOGRAPH FINAL part350 Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL 54235-207_ef7c70ec-2036-49bd-a429-823855e607f2 54235-207 HUMAN OTC DRUG FRAICHEUR THE VERT ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20081001 OTC MONOGRAPH FINAL part350 Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL 54235-208_c74d09ec-f385-4277-a4c5-8fe2bda3d914 54235-208 HUMAN OTC DRUG FRAICHEUR BAMBOU ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20081001 OTC MONOGRAPH FINAL part350 Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL 54235-209_96b0cc1c-1c15-4e16-93e1-592093074a8e 54235-209 HUMAN OTC DRUG FRAICHEUR CHEVREFEUILLE ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20090201 OTC MONOGRAPH FINAL part350 Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL 54247-001_f20bb80f-9097-4f74-911b-022f5cb8d5cc 54247-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Bishop Welding Supply OXYGEN 995 mL/L 54260-001_acd55a25-df0d-4fae-9830-79f1ca2fce30 54260-001 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19000101 NDA NDA206009 Nitrous Oxide NITROUS OXIDE 990 mL/L 54272-101_fcec509a-08a3-4af1-90ef-a79bf01e3ec3 54272-101 HUMAN OTC DRUG ACNE CORRECTING CLEANSER SALICYLIC ACID GEL TOPICAL 20130221 OTC MONOGRAPH FINAL part333D CEN BEAUTY LLC SALICYLIC ACID 2 g/100mL 54272-102_59df130f-70ef-4fad-aadc-01b7de555952 54272-102 HUMAN OTC DRUG BLEMISH CORRECTING SERUM BENZOYL PEROXIDE GEL TOPICAL 20130221 OTC MONOGRAPH FINAL part333D CEN BEAUTY LLC BENZOYL PEROXIDE 5 g/100mL 54272-103_27fdba83-576d-4d5c-8bd5-f61967fb62b3 54272-103 HUMAN OTC DRUG BLEMISH CORRECTING SERUM SENSITIVE SALICYLIC ACID GEL TOPICAL 20130221 OTC MONOGRAPH FINAL part333D CEN BEAUTY LLC SALICYLIC ACID 2 g/100mL 54272-201_ec0b39fc-fb2a-4269-b9c8-77deed734b95 54272-201 HUMAN OTC DRUG BRIGHTEN SPF 30 ZINC OXIDE OCTINOXATE CREAM TOPICAL 20130221 OTC MONOGRAPH FINAL part352 CEN BEAUTY LLC OCTINOXATE; ZINC OXIDE 6; 15 g/100mL; g/100mL 54272-202_03661a43-9815-4aeb-b1e4-2b9ad491f3c1 54272-202 HUMAN OTC DRUG FIRMING DAY SPF 30 ZINC OXIDE OCTINOXATE CREAM TOPICAL 20130221 OTC MONOGRAPH FINAL part352 CEN BEAUTY LLC OCTINOXATE; ZINC OXIDE 6; 15 g/100mL; g/100mL 54272-301_2d9bf516-a130-4aaf-8efb-600250a7236d 54272-301 HUMAN OTC DRUG BRIGHTEN LIGHTENING HYDROQUINONE GEL TOPICAL 20130221 OTC MONOGRAPH NOT FINAL part358A CEN BEAUTY LLC HYDROQUINONE 2 g/100mL 54273-000_f9580785-df67-4ea1-aa5f-883539c43618 54273-000 HUMAN OTC DRUG BeKoool Itch Relief LIDOCAINE, MENTHOL PATCH TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part348 Heatmax Inc. LIDOCAINE; MENTHOL 20; 10 mg/mL; mg/mL 54288-103_16376765-410c-4d95-b65a-c11e78f7cb79 54288-103 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140808 NDA NDA205029 BPI Labs, LLC EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 54291-021_4d88cd04-3d1a-4c01-b9fe-600bbfea6ba2 54291-021 HUMAN OTC DRUG HealthCare Plus Alcohol Swabs SWAB TOPICAL 20091005 OTC MONOGRAPH NOT FINAL part333 Canadian Custom Packaging Company ISOPROPYL ALCOHOL .7 mL/1 54295-301_08570570-526b-40fd-aebb-d7e615c89f9b 54295-301 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 9 Sulfur 4.5 Wash Sulfacetamide Sodium and Sulfur RINSE TOPICAL 20140826 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 9; 4.5 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 54295-302_aa82c73c-e094-46a9-9d16-4a1201d4857b 54295-302 HUMAN PRESCRIPTION DRUG SALICYLIC ACID SALICYLIC ACID CREAM TOPICAL 20121210 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC SALICYLIC ACID 60 mg/g 54295-303_d260115b-606e-45f6-bee5-6dd44b36c9e4 54295-303 HUMAN PRESCRIPTION DRUG SALICYLIC ACID SALICYLIC ACID LOTION TOPICAL 20121210 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC SALICYLIC ACID 60 mg/g 54295-304_32eeeb54-937e-487a-b260-7425e5b176dd 54295-304 HUMAN PRESCRIPTION DRUG Salicylic Acid salicylic acid SOLUTION TOPICAL 20131116 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC SALICYLIC ACID 275 mg/mL 54295-307_0b012ab1-6a8d-4159-94bf-3397bf10244d 54295-307 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium, Sulfur Sulfacetamide Sodium, Sulfur LOTION TOPICAL 20130701 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 54295-308_f40b2818-3dc5-424f-8ce8-4c74c82a6fc6 54295-308 HUMAN PRESCRIPTION DRUG UREA UREA CREAM TOPICAL 20140901 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC UREA 40 g/100g 54295-310_6f52764a-0966-4be2-adb6-7c68d1ac33d7 54295-310 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE SODIUM SULFACETAMIDE LIQUID TOPICAL 20130831 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 54295-311_bdc0030b-9518-493c-bdc0-a2dcd54f1421 54295-311 HUMAN PRESCRIPTION DRUG UREA UREA CREAM TOPICAL 20131202 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC UREA 39 g/100g 54295-312_bd2f69d5-cd79-4edd-8fd1-b99c3642ea45 54295-312 HUMAN PRESCRIPTION DRUG UREA UREA LOTION TOPICAL 20140919 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC UREA 40 g/100g 54296-1001_93c5e396-0dac-4c3d-9b3e-fc24a42b44b9 54296-1001 HUMAN OTC DRUG JEUNCELL a drug for atopic dermatitis RUMEX CRISPUS WHOLE LIQUID TOPICAL 20121125 UNAPPROVED DRUG OTHER Jeun Cell Ltd RUMEX CRISPUS WHOLE 5 mg/100mL 54296-2001_8f8e9c7b-c488-418f-8bf0-69aca407d2ce 54296-2001 HUMAN OTC DRUG JEUNCELL Hair Loss Prevention and Hair Growth Tonic PINE NEEDLE OIL (PINUS MUGO) LIQUID TOPICAL 20121125 UNAPPROVED DRUG OTHER Jeun Cell Ltd PINE NEEDLE OIL (PINUS MUGO) 5 mg/100mL 54296-3001_b047040a-c85b-4c6a-89f2-09ab994b1785 54296-3001 HUMAN OTC DRUG JEUNCELL Hair restorer and Hair Growth Solution NIACIN SHAMPOO TOPICAL 20121125 UNAPPROVED DRUG OTHER Jeun Cell Ltd NIACIN 2 mg/100mL 54298-515_d3f5f74d-009b-41cf-b402-b9433fc86994 54298-515 HUMAN OTC DRUG INDUSTRIAL ANTISEPTIC SANITIZER alcohol GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 INDUSTRIAL SPECIALTIES, INC. ALCOHOL 600 mL/1000mL 54300-0001_6e83dce7-81fd-422e-8c9c-90e9c73e2693 54300-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19920730 UNAPPROVED MEDICAL GAS B&K Home Medical Services, Inc. OXYGEN 99 L/100L 54305-102_4392181d-fd1f-41f2-a9be-6ed40e60178c 54305-102 HUMAN OTC DRUG SUGAR FREE LEMON MINT HERB THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola Ag MENTHOL 1.1 mg/1 54305-108_c1e6d5c5-54af-4ef8-9994-ee529b12749a 54305-108 HUMAN OTC DRUG NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 2 mg/1 54305-175_1b2b0748-5610-41dc-921c-3162bca22635 54305-175 HUMAN OTC DRUG THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 4.8 mg/1 54305-221_14b0072a-3afd-4272-a057-02b67b504589 54305-221 HUMAN OTC DRUG MENTHOL FRESH COUGH SUPPRESSANT MENTHOL LOZENGE ORAL 20120207 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 8 mg/1 54305-313_49d9b07e-9985-4f9b-ad4f-1978ca6650fe 54305-313 HUMAN OTC DRUG DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL LOZENGE ORAL 20110403 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 8.3 mg/1 54305-331_ca0f7962-a69a-4abf-9574-e1b3c6102552 54305-331 HUMAN OTC DRUG DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL LOZENGE ORAL 20110403 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 8.5 mg/1 54305-467_3a020bb0-5b31-4b33-abd0-50681c6daa12 54305-467 HUMAN OTC DRUG Natural Honey Lemon with Echinacea Cough Suppressant Throat Drops MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 3.5 mg/1 54305-489_ac3b76b1-593b-47b8-85be-1ab20a775113 54305-489 HUMAN OTC DRUG NATURAL LEMON MINT HERB THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola Ag MENTHOL 1.5 mg/1 54305-507_abdb96e0-cbfd-4a4a-b85b-77266d1bcbfe 54305-507 HUMAN OTC DRUG Natural Cherry Honey Herb Throat Drops MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola Ag MENTHOL 1.8 mg/1 54305-617_ad8955c9-9b4c-4800-bfd9-eaf92386684d 54305-617 HUMAN OTC DRUG EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL LOZENGE ORAL 20130527 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 8.3 mg/1 54305-676_144050b3-5b22-4c22-8794-9e4e1918f0ff 54305-676 HUMAN OTC DRUG NATURAL LEMON MINT HERB THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola Ag MENTHOL 1.6 mg/1 54305-802_22a42274-da71-4443-976e-e3acc52f6baa 54305-802 HUMAN OTC DRUG SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS MENTHOL LOZENGE ORAL 19420412 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 4.8 mg/1 54305-840_ebcd20e2-49ff-4db6-9222-fc2a5bf8a1eb 54305-840 HUMAN OTC DRUG SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 4.1 mg/1 54305-909_55f87ae5-1baf-4ae0-81c7-f129baf583d2 54305-909 HUMAN OTC DRUG Natural Cherry Honey Herb Throat Drops MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola Ag MENTHOL 2 mg/1 54305-923_71ece893-4c9e-48cb-887b-720cfff7b106 54305-923 HUMAN OTC DRUG THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 5.3 mg/1 54305-941_2290bf8f-70b9-4f20-9fe7-52cdecc4b206 54305-941 HUMAN OTC DRUG NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 1.5 mg/1 54305-976_ee3bfd04-9dc3-40e9-941a-5eddc03cac23 54305-976 HUMAN OTC DRUG SUGAR FREE SWISS CHERRY HERB THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola Ag MENTHOL 2.2 mg/1 54312-019_001ccfe8-77be-4b35-83b4-99066851cb9a 54312-019 HUMAN OTC DRUG VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC NEOMYCIN SULFATE OINTMENT TOPICAL 20120828 OTC MONOGRAPH FINAL part333B Compania Internacional de Comercio, S.A. de C.V. NEOMYCIN SULFATE 3.5 mg/g 54312-125_07cee53b-4290-4ccc-b9c6-dc74105718ae 54312-125 HUMAN OTC DRUG Derman Antifungal ZINC UNDECYLENATE CREAM TOPICAL 20130812 OTC MONOGRAPH FINAL part333C Compania Internacional de Comercio, S.A.P.I de C.V. UNDECYLENIC ACID; ZINC UNDECYLENATE 5; 18 g/100g; g/100g 54312-270_59247b31-26c7-4d63-bd13-3904bd1738b1 54312-270 HUMAN OTC DRUG AOGel Hand Sanitizer Kids Alcohol GEL TOPICAL 20101014 OTC MONOGRAPH NOT FINAL part333E Compania Internacional de Comercio, S.A. de C.V. ALCOHOL 70 g/100mL 54312-275_bf81eca4-4cea-491f-b14c-3ef31c28a1fd 54312-275 HUMAN OTC DRUG AOGel Alcohol GEL TOPICAL 20101122 OTC MONOGRAPH NOT FINAL part333E Compania Internacional de Comercio, S.A. de C.V. ALCOHOL 70 g/100mL 54312-275_fc7ed5a3-fff1-4b9e-b62a-6797bd39fedb 54312-275 HUMAN OTC DRUG AOGel Alcohol GEL TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333E Compania Internacional de Comercio, S.A. de C.V. ALCOHOL 70 g/100mL 54312-325_1c651bfb-fdd9-4c2e-b5bb-243a1f703e18 54312-325 HUMAN OTC DRUG DERMAN ANTIFUNGAL UNDECYLENIC ACID SPRAY TOPICAL 20131021 OTC MONOGRAPH FINAL part333C Compania Internacional de Comercio, S.A. de C.V. UNDECYLENIC ACID 100 mg/mL 54312-525_ca081997-f09a-40f1-85df-5cbba20238a3 54312-525 HUMAN OTC DRUG VITACILINA Bebe Diaper Rash ALLANTOIN, ZINC OXIDE OINTMENT TOPICAL 20130930 OTC MONOGRAPH FINAL part347 Compania Internacional de Comercio, S.A. de C.V. ALLANTOIN; ZINC OXIDE 10; 250 mg/g; mg/g 54312-825_e53a1ea2-ec19-4028-bbbb-1b2c5f672062 54312-825 HUMAN OTC DRUG Rocainol TOPICAL ANALGESIC METHYL SALICYLATE, MENTHOL OINTMENT TOPICAL 20130930 OTC MONOGRAPH NOT FINAL part348 Compania Internacional de Comercio, S.A. de C.V. MENTHOL; METHYL SALICYLATE 8; 16 g/100g; g/100g 54312-925_7742aa42-ca41-4436-b348-ef5558172f74 54312-925 HUMAN OTC DRUG DERMAN ANTIFUNGAL ZINC UNDECYLENATE, UNDECYLENIC ACID POWDER TOPICAL 20130930 OTC MONOGRAPH FINAL part333C Compania Internacional de Comercio, S.A. de C.V. UNDECYLENIC ACID; ZINC UNDECYLENATE 2; 20 g/100g; g/100g 54316-123_637eb8ba-e8d3-4c28-827b-8bf25cf2178a 54316-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000101 UNAPPROVED MEDICAL GAS Youngstown Oxygen & Welding Supply, Inc. OXYGEN .995 L/L 54340-003_e7bdbe0b-ad74-484e-9e4b-7718d7992a21 54340-003 HUMAN OTC DRUG Dial For Men Dandruff Control Hair and Body Wash Pyrithione Zinc SOLUTION TOPICAL 20101220 OTC MONOGRAPH FINAL part358H The Dial Corporation PYRITHIONE ZINC .95 g/100g 54340-004_6d05f765-e802-4a5a-83f6-c690030776a7 54340-004 HUMAN OTC DRUG Dry Idea Advanced Dry Aluminum Zirconium Pentachlorohydrex Gly LIQUID TOPICAL 20110519 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 16.3 g/100mL 54340-005_89f039bf-2ba7-40e0-8376-e18e346cc0b2 54340-005 HUMAN OTC DRUG Dry Idea Advanced Dry-Powder Fresh Aluminum Zirconium Pentachlorohydrex Gly LIQUID TOPICAL 20111018 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 16.3 g/100mL 54340-006_6c5638ff-8f91-48a7-99d1-c19df233e15e 54340-006 HUMAN OTC DRUG Dry Idea Advanced Dry-Cotton Dry Aluminum Zirconium Pentachlorohydrex Gly LIQUID TOPICAL 20111119 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 16.3 g/100mL 54340-011_7bae8650-976d-4ec5-b0b1-a9161d87908c 54340-011 HUMAN OTC DRUG RG TD5 Inv.Solid Antiperspirant Deodorant Cooling Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20111108 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 2.0944 g/11.9g 54340-068_b285a8f0-b3f5-472e-a1e6-68d6036dcf87 54340-068 HUMAN OTC DRUG RG Sport Inv.Solid Antiperspirant Deodorant Fresh Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20110218 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 14.062 g/79g 54340-107_cbcd58a3-60bb-4d12-9da3-83cb2e150982 54340-107 HUMAN OTC DRUG Dial Professional Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation ALCOHOL 72 mL/100mL 54340-178_9780ec5c-987f-4b91-815c-d70d69ba3db8 54340-178 HUMAN OTC DRUG Dial Lavender and Twilight Jasmine Antibacterial Body Wash Triclosan SOLUTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL 54340-179_86af53e9-6b63-4f66-9d7b-494cc7162df1 54340-179 HUMAN OTC DRUG Dial Mountain Fresh Antibacterial Body Wash Triclosan SOLUTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL 54340-180_d8b50052-fcb5-4df6-9f7a-9224d5a15326 54340-180 HUMAN OTC DRUG Dial Tropical Escape Antibacterial Body Wash Triclosan SOLUTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL 54340-187_a13c3891-457a-4a6b-a169-a933288aee23 54340-187 HUMAN OTC DRUG Right Guard Sport I.S. Antiperspirant Deodorant Active Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140110 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 14 g/73g 54340-208_ed47b010-8c8c-4290-8c61-7ed8546c3337 54340-208 HUMAN OTC DRUG Right Guard Sport Active Aluminum Zirconium Trichlorohydrex GLY STICK TOPICAL 20121201 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 10.318 g/73.7g 54340-231_78cab32e-0c23-45d5-a087-991113a90244 54340-231 HUMAN OTC DRUG Right Guard Sport I.S. Antiperspirant Deodorant Triathlon Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140108 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 14 g/73g 54340-233_e569b395-021a-40b8-84ad-3a997c820bcd 54340-233 HUMAN OTC DRUG Right Guard Sport Fresh Invisible Solid Antiperspirant and Deodorant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140130 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 14 g/73g 54340-400_37b69879-b0a1-42cb-a3e2-bd73f9bb97c5 54340-400 HUMAN OTC DRUG Dial Acne Control Deep Cleansing Face Wash Salicylic Acid SOLUTION TOPICAL 20140701 OTC MONOGRAPH FINAL part358H The Dial Corporation SALICYLIC ACID 20 mg/mL 54340-410_caa27872-ec9b-42f6-9361-b5d3365c311c 54340-410 HUMAN OTC DRUG Dial Acne Control Deep Cleansing Body Wash Salicylic Acid SOLUTION TOPICAL 20140701 OTC MONOGRAPH FINAL part358H The Dial Corporation SALICYLIC ACID 20 mg/mL 54340-482_884a5466-5b5d-4489-8403-a22a57a7417e 54340-482 HUMAN OTC DRUG Soft and Dri Clear Glide IS Antiperspirant Floral Bouquet Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20100127 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 13 g/73g 54340-503_f0f19ff1-cbd8-4486-83b2-b1a73528462a 54340-503 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash White Tea and Vitamin E TRICLOSAN SOLUTION TOPICAL 20130325 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN 4.6 mg/mL 54340-651_2b12cc61-da89-449b-8dae-a69f04a14e69 54340-651 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash with Lotion Clean Citrus, Gentle on skin TRICLOSAN SOLUTION TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mL/1000mL 54340-652_dcad8179-b43b-42a4-b4f2-6232378ec18b 54340-652 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash with Lotion Cranberry with Antioxidants TRICLOSAN SOLUTION TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mL/1000mL 54340-666_e8089487-da0a-413e-a5be-27df9290fb77 54340-666 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash with Lotion Iced Cranberry, Gentle on Skin TRICLOSAN SOLUTION TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mL/1000mL 54340-681_95039f14-c642-42ba-95f7-eab168de9a63 54340-681 HUMAN OTC DRUG Dry Idea A.Dry Antiperspirant Unscented ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY LIQUID TOPICAL 20110614 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 16.3 mL/96.1mL 54340-682_0efe1eb7-c08d-460c-9875-2413d8eb32ba 54340-682 HUMAN OTC DRUG Dry Idea AD Antiperspirant Roll-On Powder Fresh ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY LIQUID TOPICAL 20100521 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 16.3 mL/96.1mL 54340-683_af4585e3-b572-447a-914c-e4522ab0f235 54340-683 HUMAN OTC DRUG Dry Idea A.Dry Antiperspirant Unscented ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY LIQUID TOPICAL 20110614 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 16.3 mL/96.1mL 54340-700_5b1a3d06-cc49-46d4-974d-cefd3456bff8 54340-700 HUMAN OTC DRUG Dial Country Orchard Antibacterial Soap with Moisturizer TRICLOSAN SOLUTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL 54340-701_f5c14c18-5a92-4284-846d-90479babd572 54340-701 HUMAN OTC DRUG Right Guard Total Defense Cool Peak Antiperspirant/Deodorant STICK TOPICAL 20070726 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 4.902 g/57g 54340-702_165fa61e-8798-4cce-b74c-e1fd77676d10 54340-702 HUMAN OTC DRUG Right Guard Total Defense Fresh Blast Antiperspirant/Deodorant STICK TOPICAL 20070726 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 4.902 g/57g 54340-751_4664b3e8-69ca-4cbd-8a0e-84f95c2a3b57 54340-751 HUMAN OTC DRUG RG TD5 Inv.Solid Antiperspirant Deodorant Fresh Blast Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20111027 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 2.0944 g/11.9g 54340-764_6fba08e0-8873-43b1-8598-2b02b1fbc06a 54340-764 HUMAN OTC DRUG Berkley Jensen Hypoallergenic Antibacterial Hand Soap Soap Enriched with Vitamin E and Aloe Vera Moisturizers TRICLOSAN SOLUTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL 54340-771_a122dfac-39d7-428d-a2da-046a9a1f5ae5 54340-771 HUMAN OTC DRUG Dry Idea A.Dry Inv.Sol. Antiperspirant Cool Blast Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20111109 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 15.4 g/73g 54340-777_993776f4-cd4e-4472-be7d-6eb5d858aedc 54340-777 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash with Lotion Gentle on Skin, Frosted Pear with Lotion TRICLOSAN SOLUTION TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mL/1000mL 54340-778_dce76cf2-4131-47c8-ade1-46decd7a7811 54340-778 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash with Lotion Original Scent, Gentle on skin TRICLOSAN SOLUTION TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mL/1000mL 54340-779_1941255a-d754-41d4-9d73-74c8befcea69 54340-779 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash with Lotion Cool Plum, Gentle on skin TRICLOSAN SOLUTION TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mL/1000mL 54340-783_ffe74a52-154b-4528-af45-ce8aa27ab62a 54340-783 HUMAN OTC DRUG Dial Clear and Refresh Antibacterial Hand Soap Clear TRICLOSAN SOLUTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL 54340-797_e695f870-7c83-46af-94a9-3eee2ffce98d 54340-797 HUMAN OTC DRUG Dial Aloe Antibacterial Soap with Moisturizer TRICLOSAN SOLUTION TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL 54340-798_7e51aab9-518f-4944-a1a5-7ea0f2e59fb5 54340-798 HUMAN OTC DRUG Dial Pomeganate and Tangerine Antibacterial Soap with Moisturizer TRICLOSAN SOLUTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL 54340-799_d2ab64c6-776c-4019-b07d-49da210b8742 54340-799 HUMAN OTC DRUG Dial Spring Water Antibacterial Soap with Moisturizer TRICLOSAN SOLUTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL 54340-800_e5d2d2c7-f2ec-43f4-9afd-808b93e732ff 54340-800 HUMAN OTC DRUG Dial Gold Antibacterial Soap with Moisturizer TRICLOSAN SOLUTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL 54340-801_1c76ea3a-0c6b-4963-a415-8366121484f0 54340-801 HUMAN OTC DRUG Dial Mountain Fresh Antibacterial Soap with Moisturizers TRICLOSAN SOLUTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL 54340-802_38933b72-8c01-4212-a489-455bf28ef783 54340-802 HUMAN OTC DRUG Dial White Tea and Vitamin E Antibacterial Hand Soap Triclosan SOLUTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL 54340-809_5206165a-25dc-469c-a22e-fe76d2330463 54340-809 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash with Lotion Soothing White Tea, Gentle on skin TRICLOSAN SOLUTION TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mL/1000mL 54340-810_19fe0844-6e5b-4828-a064-73a0378e01c9 54340-810 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash Hello Kitty TRICLOSAN SOLUTION TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 g/100mL 54340-813_77f9abb5-5d4a-4886-8989-b8347281f7d2 54340-813 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Washkitchen crisp limkitchen crisp lim kitchen crisp lime TRICLOSAN SOLUTION TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mg/1000mL 54340-814_33d15242-ee9b-4788-8344-5ea070cd0b4a 54340-814 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Washholiday line holiday line holiday line TRICLOSAN SOLUTION TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN 4.6 mg/mL 54340-833_e1ce3ce2-e3a9-415b-be5d-73422605af17 54340-833 HUMAN OTC DRUG RG Sport Inv.Solid Antiperspirant Deodorant Cool Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20110323 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 14.062 g/79g 54340-842_c77afc69-89e9-4888-b53b-e21aae754ed5 54340-842 HUMAN OTC DRUG Soft and Dri Clear Glide IS Antiperspirant Powder Soft Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20110614 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 13 g/73g 54340-866_e90ce213-916a-4934-a281-2966e3180401 54340-866 HUMAN OTC DRUG Dry Idea A.Dry Antiperspirant Solid Powder Fresh Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20110211 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 15.4 g/73g 54340-969_f5e4b981-63b3-4b82-862d-ca8edf9458df 54340-969 HUMAN OTC DRUG Dry Idea A.Dry Antiperspirant Solid Unscented Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20110211 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 14.6 g/73g 54340-986_dce95b78-dbfb-43f6-80a8-ab07d88fa0db 54340-986 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash with Lotion Fresh Pear with Lotion TRICLOSAN SOLUTION TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mL/1000mL 54348-066_18ef45fc-66b0-40ef-9d6d-759b64b20fc4 54348-066 HUMAN PRESCRIPTION DRUG HYDROCODONE/APAP HYDROCODONE BITARTRATE, ACETAMINOPHEN TABLET ORAL 20140901 ANDA ANDA040736 PharmPak, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 54365-145_290b07bd-873f-4c91-b827-8e76879b94bc 54365-145 HUMAN OTC DRUG PVP-Iodine Sepp povidone iodine SOLUTION TOPICAL 19880201 OTC MONOGRAPH NOT FINAL part333A CareFusion 213 LLC POVIDONE-IODINE 10 mg/mL 54365-161_a146bdc0-24aa-4121-851b-afd9b1c64bdd 54365-161 HUMAN OTC DRUG Iodine Sepp Iodine TINCTURE TOPICAL 19880201 OTC MONOGRAPH NOT FINAL part333A CareFusion 213 LLC IODINE 20 mg/mL 54365-170_eb3a003b-577f-4bb2-a45a-ac71f6b970d7 54365-170 HUMAN OTC DRUG Isopropyl Alcohol Sepp isopropyl alcohol SOLUTION TOPICAL 19880201 OTC MONOGRAPH NOT FINAL part333A CareFusion 213 LLC ISOPROPYL ALCOHOL .7 mL/mL 54365-200_4164b660-93ea-4d19-8eb2-971138fef54b 54365-200 HUMAN OTC DRUG Blood Culture Prep Kit Isopropyl alcohol and iodine KIT 19880201 OTC MONOGRAPH NOT FINAL part333A CareFusion 213 LLC 54365-400_044e24de-c76c-0161-e054-00144ff8d46c 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20140723 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL 54365-400_0d6149f8-f71e-46d7-a801-12c66dc23e65 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl aclohol SOLUTION TOPICAL 20060818 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL 54365-400_0d8d9c21-abfe-4e6b-9fd8-06cc27d2c7a3 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20050510 NDA NDA021555 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL 54365-400_36d17493-0c49-4153-80db-46233d98dc79 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20020426 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL 54365-400_4acc7baa-0bfa-4130-9678-9c9db5345f6b 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20060818 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL 54365-400_4c91e48d-33fe-46b9-9000-2e2dbbfd01aa 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20060818 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL 54365-400_50e7289b-cd04-4d2d-a953-abe96baa9db8 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20000714 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL 54365-400_5a25c461-dc07-4ff9-8707-55b0d43b7606 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20020426 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL 54365-400_78850499-5a03-4883-8523-d7d42b19e848 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20000714 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL 54365-400_86b1407a-b51f-4c9f-97eb-9dd58653e030 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20050510 NDA NDA021555 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL 54365-400_dc04c7a3-2b9b-4c48-9cde-46a7a94492be 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20021007 NDA NDA021555 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL 54365-400_e28feeb2-9a64-4d80-8579-2d6bea34771e 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20020426 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL 54365-400_fd3b0866-4f68-435f-8983-3bdbf200b836 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20000714 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL 54371-471_f22e9a97-1c45-472a-aee3-17c0a4223cbb 54371-471 HUMAN OTC DRUG OraBrite SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20111031 OTC MONOGRAPH NOT FINAL part356 Oraline, Inc. SODIUM FLUORIDE .22 g/100g 54384-1072_75313f91-3cdb-4e6b-9e65-fd8f8eaf9338 54384-1072 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19720101 UNAPPROVED MEDICAL GAS American Oxygen Company, Inc OXYGEN 99 L/100L 54396-801_8ec18670-b429-432f-b7c5-7a43fd397c47 54396-801 HUMAN PRESCRIPTION DRUG Krystexxa pegloticase INJECTION, SOLUTION INTRAVENOUS 20100914 BLA BLA125293 Savient Pharmaceuticals, Inc. PEGLOTICASE 8 mg/mL Urate Oxidase [Chemical/Ingredient],Uric Acid-specific Enzyme [EPC] 54410-001_dd133d21-b8a2-40e5-b31d-fd8f272adbdf 54410-001 HUMAN OTC DRUG 4 SURE Plus E3 Instant Foam Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part333A DevMar Products LLC BENZALKONIUM CHLORIDE 1 mg/mL 54416-001_67a671f3-f902-46a8-a740-8fad89c21920 54416-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19931117 UNAPPROVED MEDICAL GAS Nordan Smith Welding Supply OXYGEN 995 mL/L 54416-002_4d508bb2-43f2-4b7e-9a2e-df14849d8fe1 54416-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS ENDOSINUSIAL 19931118 UNAPPROVED MEDICAL GAS Nordan Smith Welding Supply NITROGEN 995 mL/L 54416-003_9fef6575-7bd5-47ca-aca5-ec57eb6d173a 54416-003 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19940112 UNAPPROVED MEDICAL GAS Nordan Smith Welding Supply CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 54416-004_433f76dd-f6af-44a8-9907-85b57b11953a 54416-004 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19931118 UNAPPROVED MEDICAL GAS Nordan Smith Welding Supply AIR 215 mL/L 54416-005_b4dc71a9-6a28-445a-92d8-a8edef36b95a 54416-005 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19940225 UNAPPROVED MEDICAL GAS Nordan Smith Welding Supply HELIUM 995 mL/L 54416-006_af88eceb-b8a7-4106-b732-13ccc5f46cf1 54416-006 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19950104 UNAPPROVED MEDICAL GAS Nordan Smith Welding Supply NITROUS OXIDE 990 mL/L 54427-001_5c12489e-f8df-4704-9d67-72b4277d1efe 54427-001 HUMAN OTC DRUG BIOARPIL SALICYLIC ACID OINTMENT TOPICAL 20120701 OTC MONOGRAPH FINAL part358H BIOARPIL USA, INC. SALICYLIC ACID 2.8 g/140g 54429-0101_8306b85d-a2e0-4740-8f1b-703742e58912 54429-0101 HUMAN OTC DRUG Alcohol Prep Pad isopropyl alcohol SWAB TOPICAL 20121226 OTC MONOGRAPH NOT FINAL part333A Foshan Flying Medical Products Co., Ltd. ISOPROPYL ALCOHOL .7 mL/mL 54429-0102_71937731-2b5b-4517-8d73-f917fab5dbc8 54429-0102 HUMAN OTC DRUG PHARMACIST CHOICE ALCOHOL PREP PAD isopropyl alcohol SWAB TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333A Foshan Flying Medical Products Co., Ltd. ISOPROPYL ALCOHOL .7 mL/mL 54429-0103_73271a51-448e-42b6-a49c-e8c5eeded43b 54429-0103 HUMAN OTC DRUG BZK antiseptic swab benzalkonium chloride SWAB TOPICAL 20121227 OTC MONOGRAPH NOT FINAL part333A Foshan Flying Medical Products Co., Ltd. BENZALKONIUM CHLORIDE 1.3 mg/mL 54429-0104_eac50804-f093-4a9a-b57a-e4ce59e418a2 54429-0104 HUMAN OTC DRUG Povidone-iodine prep pad povidone-iodine SWAB TOPICAL 20130115 OTC MONOGRAPH FINAL part333C Foshan Flying Medical Products Co., Ltd. POVIDONE-IODINE 9.43 g/100g 54429-0106_a363b572-fd50-4f2f-bc69-f9232c2deb12 54429-0106 HUMAN OTC DRUG Antiseptic Cleansing Wipes chlorhexidine gluconate SWAB TOPICAL 20121227 UNAPPROVED DRUG OTHER Foshan Flying Medical Products Co., Ltd. CHLORHEXIDINE GLUCONATE .0002 mg/mg 54436-010_0112c9db-7b47-467e-bd8e-2f3c6af7799e 54436-010 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 10 mg/.4mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 54436-015_0112c9db-7b47-467e-bd8e-2f3c6af7799e 54436-015 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 15 mg/.4mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 54436-020_0112c9db-7b47-467e-bd8e-2f3c6af7799e 54436-020 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 20 mg/.4mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 54436-025_0112c9db-7b47-467e-bd8e-2f3c6af7799e 54436-025 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 25 mg/.4mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 54436-075_0112c9db-7b47-467e-bd8e-2f3c6af7799e 54436-075 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 7.5 mg/.4mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 54451-001_0a5bc10c-820a-46fe-bcc2-5edab58f56ea 54451-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000101 UNAPPROVED MEDICAL GAS Baker's Gas & Welding Supplies OXYGEN 999 mL/L 54458-300_281dd486-431b-435a-a344-7462b57b6b19 54458-300 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110922 ANDA ANDA090615 International Labs, Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54458-301_281dd486-431b-435a-a344-7462b57b6b19 54458-301 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110922 ANDA ANDA090615 International Labs, Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54458-302_281dd486-431b-435a-a344-7462b57b6b19 54458-302 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110922 ANDA ANDA090615 International Labs, Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54458-881_305790e4-7d2b-4f48-ae20-e7949f5e375c 54458-881 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20140601 ANDA ANDA090548 International Labs, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-883_f779d4d5-720f-4b07-9b91-08d775292e86 54458-883 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20131208 NDA AUTHORIZED GENERIC NDA021073 International Labs, Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 54458-884_f779d4d5-720f-4b07-9b91-08d775292e86 54458-884 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20131208 NDA AUTHORIZED GENERIC NDA021073 International Labs, Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 54458-885_f779d4d5-720f-4b07-9b91-08d775292e86 54458-885 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20131208 NDA AUTHORIZED GENERIC NDA021073 International Labs, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 54458-886_7e63a38c-fa9e-40f9-8552-ca8804789d40 54458-886 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20140304 ANDA ANDA077912 International Labs, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54458-887_b26be098-d2a7-4dc8-b57b-ccd5ec40e48b 54458-887 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20140201 ANDA ANDA077927 International Labs, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54458-888_c9b64721-a2ac-4bf8-b3a1-b370979b773e 54458-888 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20131202 ANDA ANDA076999 International Labs, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 54458-889_3dbd76a4-dcfe-42ec-a18f-88f70c735f85 54458-889 HUMAN PRESCRIPTION DRUG CITALOPRAM CITALOPRAM TABLET, FILM COATED ORAL 20140101 ANDA ANDA077038 International Labs, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54458-890_9c79865c-9ed1-49d2-9c5d-82758d87757f 54458-890 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET, FILM COATED ORAL 20131004 ANDA ANDA078605 International Labs, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 54458-891_64ec6f56-7d43-4943-b1c0-f14bed23a0de 54458-891 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130920 ANDA ANDA076765 International Labs, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54458-892_64ec6f56-7d43-4943-b1c0-f14bed23a0de 54458-892 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130919 ANDA ANDA076765 International Labs, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54458-893_d20a2845-c5df-4eb1-9e0e-796780f21a8c 54458-893 HUMAN PRESCRIPTION DRUG Benazepril Benazepril TABLET, COATED ORAL 20130919 ANDA ANDA076211 International Labs, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54458-894_aee80355-077d-4d98-a63d-e8dc8f584a1f 54458-894 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130919 ANDA ANDA077837 International Labs, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-895_ab82058c-1e03-40de-9511-1eb31bd31722 54458-895 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20130801 ANDA ANDA077995 International Labs, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54458-896_f940b397-d5a2-4505-9869-f6cc0f143da9 54458-896 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20130801 ANDA ANDA077534 International Labs, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54458-899_aee80355-077d-4d98-a63d-e8dc8f584a1f 54458-899 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130901 ANDA ANDA077837 International Labs, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-900_aee80355-077d-4d98-a63d-e8dc8f584a1f 54458-900 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130901 ANDA ANDA077837 International Labs, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-903_5d0e9a4c-4636-497f-aa83-1e9674b9a71a 54458-903 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine TABLET ORAL 20120914 ANDA ANDA078925 International Labs, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54458-904_f4846b10-51be-4558-aeed-0c38d948d439 54458-904 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20120220 ANDA ANDA078043 International Labs, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54458-905_10e8fce7-3713-40b9-b11e-9acb5c2a5578 54458-905 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20120220 ANDA ANDA077321 International Labs, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54458-906_10e8fce7-3713-40b9-b11e-9acb5c2a5578 54458-906 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20120220 ANDA ANDA077321 International Labs, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54458-907_3ab316c0-7e0f-427d-b192-73052f404bd6 54458-907 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20120220 ANDA ANDA077912 International Labs, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54458-908_26f55531-daef-4a98-960b-68b1cde73299 54458-908 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20120220 ANDA ANDA076056 International Labs, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-909_ff8bafe4-8631-48e4-b88d-279efabc8c88 54458-909 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20120220 ANDA ANDA077944 International Labs, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54458-910_3ab316c0-7e0f-427d-b192-73052f404bd6 54458-910 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20120220 ANDA ANDA077912 International Labs, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54458-912_d21ed36b-e644-4397-81c3-b0e62df89ee1 54458-912 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram TABLET ORAL 20120220 ANDA ANDA078216 International Labs, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54458-913_6fd59864-729e-409c-beb7-f328bd1bb6e1 54458-913 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET ORAL 20120220 ANDA ANDA077670 International Labs, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54458-914_0493f1d2-5bea-4985-a9b9-9676279ef0dd 54458-914 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20080327 ANDA ANDA075551 International Labs, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-915_0493f1d2-5bea-4985-a9b9-9676279ef0dd 54458-915 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20080327 ANDA ANDA075551 International Labs, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-916_0493f1d2-5bea-4985-a9b9-9676279ef0dd 54458-916 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20080327 ANDA ANDA075551 International Labs, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-920_112317f4-32a7-4f86-addd-8135a37d86c5 54458-920 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20101015 ANDA ANDA077921 International Labs, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54458-921_f042ddc1-9242-4fa7-bee6-e3f8078d9b2b 54458-921 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20101015 ANDA ANDA077912 International Labs, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54458-922_081c55f6-f845-45bb-a792-d381e47235dd 54458-922 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20111007 ANDA ANDA078216 International Labs, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54458-923_968460b9-56f7-4b5d-bc15-ba94babdbdde 54458-923 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20110815 ANDA ANDA077944 International Labs, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54458-924_6bfe8db0-ee5c-4fbf-b107-2c70f294e7ca 54458-924 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20110901 ANDA ANDA077670 International Labs, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54458-925_6b871ee7-debd-464b-b166-c492f1b60bc7 54458-925 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20080327 ANDA ANDA076056 International Labs, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-926_6b871ee7-debd-464b-b166-c492f1b60bc7 54458-926 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20090209 ANDA ANDA076056 International Labs, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-927_8c221bbf-75c3-4e6d-ad83-4812b8e85b75 54458-927 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20130426 ANDA ANDA076056 International Labs, Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-929_ee617c88-41be-46db-b008-c4f555de13b9 54458-929 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110801 ANDA ANDA040807 International Labs, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54458-930_ee617c88-41be-46db-b008-c4f555de13b9 54458-930 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110801 ANDA ANDA040807 International Labs, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54458-931_5a183bec-4171-4f6c-9252-56da2c1d0ef5 54458-931 HUMAN PRESCRIPTION DRUG ATENOLOL ATENOLOL TABLET ORAL 20101015 ANDA ANDA077877 International Labs, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54458-932_b9e86ef9-f28f-44b3-850f-6029d57fbd72 54458-932 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20101122 ANDA ANDA076052 International Labs, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-933_b9e86ef9-f28f-44b3-850f-6029d57fbd72 54458-933 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20101127 ANDA ANDA076052 International Labs, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-934_b9e86ef9-f28f-44b3-850f-6029d57fbd72 54458-934 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20101128 ANDA ANDA076052 International Labs, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-936_572a18c1-3c6b-4e2d-a739-42798eb7e818 54458-936 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20100410 ANDA ANDA078296 International Labs, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-937_572a18c1-3c6b-4e2d-a739-42798eb7e818 54458-937 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20100403 ANDA ANDA078296 International Labs, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-938_572a18c1-3c6b-4e2d-a739-42798eb7e818 54458-938 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20100322 ANDA ANDA078296 International Labs, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54458-939_280854c7-ff39-4f4d-abf1-0d0a0bb3506d 54458-939 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100201 ANDA ANDA040780 International Labs, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54458-944_72d1c8b8-ce7b-4a55-967a-f32b0cc35cb4 54458-944 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20090512 ANDA ANDA077397 International Labs, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54458-945_72d1c8b8-ce7b-4a55-967a-f32b0cc35cb4 54458-945 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20090510 ANDA ANDA077397 International Labs, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54458-947_72d1c8b8-ce7b-4a55-967a-f32b0cc35cb4 54458-947 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20090507 ANDA ANDA077397 International Labs, Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54458-948_8ecd4c23-a94b-4364-a569-962de715f8ff 54458-948 HUMAN PRESCRIPTION DRUG NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE ORAL 20090822 ANDA ANDA077127 International Labs, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54458-950_8ecd4c23-a94b-4364-a569-962de715f8ff 54458-950 HUMAN PRESCRIPTION DRUG NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE ORAL 20090821 ANDA ANDA077127 International Labs, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54458-956_73b2a09b-b0ce-4df3-aabc-f1893efda04e 54458-956 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20090301 ANDA ANDA076402 International Labs, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54458-957_73b2a09b-b0ce-4df3-aabc-f1893efda04e 54458-957 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20090301 ANDA ANDA076402 International Labs, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54458-964_17bf5a25-9269-41c4-81ac-7323d8b3e4ae 54458-964 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20081201 ANDA ANDA077921 International Labs, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54458-965_17bf5a25-9269-41c4-81ac-7323d8b3e4ae 54458-965 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20081201 ANDA ANDA077921 International Labs, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54458-966_e75940d5-cdd4-4355-a23c-074d39d960db 54458-966 HUMAN PRESCRIPTION DRUG GLIMEPIRIDE GLIMEPIRIDE TABLET ORAL 20090206 ANDA ANDA077091 International Labs, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54458-967_e75940d5-cdd4-4355-a23c-074d39d960db 54458-967 HUMAN PRESCRIPTION DRUG GLIMEPIRIDE GLIMEPIRIDE TABLET ORAL 20090206 ANDA ANDA077091 International Labs, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54458-968_e75940d5-cdd4-4355-a23c-074d39d960db 54458-968 HUMAN PRESCRIPTION DRUG GLIMEPIRIDE GLIMEPIRIDE TABLET ORAL 20090206 ANDA ANDA077091 International Labs, Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54458-980_3dbd76a4-dcfe-42ec-a18f-88f70c735f85 54458-980 HUMAN PRESCRIPTION DRUG CITALOPRAM CITALOPRAM TABLET, FILM COATED ORAL 20080625 ANDA ANDA077038 International Labs, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54458-981_3dbd76a4-dcfe-42ec-a18f-88f70c735f85 54458-981 HUMAN PRESCRIPTION DRUG CITALOPRAM CITALOPRAM TABLET, FILM COATED ORAL 20080625 ANDA ANDA077038 International Labs, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54458-988_06976f0c-4cb0-4d0e-99a4-9c5d271318a0 54458-988 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET ORAL 20071211 ANDA ANDA077584 International Labs, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54458-989_06976f0c-4cb0-4d0e-99a4-9c5d271318a0 54458-989 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET ORAL 20071211 ANDA ANDA077584 International Labs, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54458-990_06976f0c-4cb0-4d0e-99a4-9c5d271318a0 54458-990 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET ORAL 20071211 ANDA ANDA077584 International Labs, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54458-991_4755bf76-82ff-4936-8fb0-c8825b60db7b 54458-991 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20071215 ANDA ANDA077912 International Labs, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54458-992_4755bf76-82ff-4936-8fb0-c8825b60db7b 54458-992 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20071215 ANDA ANDA077912 International Labs, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54458-993_4755bf76-82ff-4936-8fb0-c8825b60db7b 54458-993 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20071215 ANDA ANDA077912 International Labs, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54458-994_42742f5a-7cda-4b62-8264-d254196c6c09 54458-994 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20080201 ANDA ANDA077321 International Labs, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54458-995_42742f5a-7cda-4b62-8264-d254196c6c09 54458-995 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20080201 ANDA ANDA077321 International Labs, Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54458-996_42742f5a-7cda-4b62-8264-d254196c6c09 54458-996 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20080201 ANDA ANDA077321 International Labs, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54458-997_42742f5a-7cda-4b62-8264-d254196c6c09 54458-997 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20080201 ANDA ANDA077321 International Labs, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54458-998_42742f5a-7cda-4b62-8264-d254196c6c09 54458-998 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20080201 ANDA ANDA077321 International Labs, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54458-999_42742f5a-7cda-4b62-8264-d254196c6c09 54458-999 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20080201 ANDA ANDA077321 International Labs, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54473-080_5e625e37-7a05-469e-88f4-b66404c78d26 54473-080 HUMAN OTC DRUG CounterAct Cough Dextromethorphan HBr. and Guaifenesin SYRUP ORAL 20090828 OTC MONOGRAPH FINAL part341 Melaleuca, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 54473-098_0366e2e1-80fe-4980-839f-277ef17d9639 54473-098 HUMAN OTC DRUG CounterAct Childrens Pain Reliever Acetaminophen SUSPENSION ORAL 20100112 OTC MONOGRAPH NOT FINAL part343 Melaleuca, Inc. ACETAMINOPHEN 160 mg/5mL 54473-117_d36aedc4-fb4f-43f0-bf9c-89593671db06 54473-117 HUMAN OTC DRUG DermaCort Anti-Itch Hydrocortisone CREAM TOPICAL 20000802 OTC MONOGRAPH NOT FINAL part348 Melaleuca, Inc. HYDROCORTISONE 10 mg/g 54473-131_d6a4ea83-9b39-44a2-961b-9685f01209c1 54473-131 HUMAN OTC DRUG CounterAct Cough Drops Orchard Cherry Menthol LOZENGE ORAL 20080520 OTC MONOGRAPH FINAL part341 Melaleuca, Inc. MENTHOL 7 mg/1 54473-132_41e9caf1-71a5-461a-b523-4159edf8b7b1 54473-132 HUMAN OTC DRUG CounterAct Cough Drops Honey Lemon Menthol LOZENGE ORAL 20080520 OTC MONOGRAPH FINAL part341 Melaleuca, Inc. MENTHOL 7 mg/1 54473-134_8fe03304-24d2-48d5-8f51-c4db514f704d 54473-134 HUMAN OTC DRUG CounterAct IB Ibuprofen TABLET, FILM COATED ORAL 20100318 OTC MONOGRAPH NOT FINAL part343 Melaleuca, Inc. IBUPROFEN 200 mg/1 54473-137_3c300ef2-2c23-486d-b99b-1cb11b945153 54473-137 HUMAN OTC DRUG SunShades 15 Lip Balm Harvest Berry Octinoxate and Oxybenzone STICK TOPICAL 20061001 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. OCTINOXATE; OXYBENZONE 75; 30 mg/g; mg/g 54473-141_a6c8846f-00a3-45d1-aee0-664fc4839de7 54473-141 HUMAN OTC DRUG Clear Defense Ethyl alcohol GEL TOPICAL 20100409 OTC MONOGRAPH NOT FINAL part333A Melaleuca, Inc. ALCOHOL 39.184 g/70mL 54473-142_80c414e0-e372-4497-ab67-4fe067b115c2 54473-142 HUMAN OTC DRUG Clear Defense Hand Sanitizing Wipes alcohol CLOTH TOPICAL 20090201 OTC MONOGRAPH NOT FINAL part333A Melaleuca, Inc. ALCOHOL 3.32 g/1 54473-150_29f8abd2-dd0d-4959-ba71-95ab4b7ee342 54473-150 HUMAN OTC DRUG Pain-A-Trate Extra Strength Pain-Relieving Camphor and Menthol and Methyl Salicylate CREAM TOPICAL 20070501 OTC MONOGRAPH NOT FINAL part348 Melaleuca, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 32.5; 15; 150 mg/g; mg/g; mg/g 54473-151_4732d925-58a9-4c7f-b9e8-fd6afe989c05 54473-151 HUMAN OTC DRUG Alloy Antiperspirant and Deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20070501 OTC MONOGRAPH FINAL part350 Melaleuca, Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.39 g/64g 54473-152_e22b94e5-ef0a-418f-aa77-6b1df5059cca 54473-152 HUMAN OTC DRUG Body Satin Antiperspirant and Deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20070801 OTC MONOGRAPH FINAL part350 Melaleuca, Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 10.146 g/57g 54473-160_5f858d5d-ec8d-45d3-adce-234534d89435 54473-160 HUMAN OTC DRUG SUN SHADES 15 Lip Balm Cranberry Tangerine octinoxate and oxybenzone STICK TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. OCTINOXATE; OXYBENZONE 75; 30 mg/g; mg/g 54473-161_46822024-02e4-4193-af02-12af74ea320e 54473-161 HUMAN OTC DRUG SUN SHADES 15 Lip Balm Cherry Candy Cane octinoxate and oxybenzone STICK TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. OCTINOXATE; OXYBENZONE 75; 30 mg/g; mg/g 54473-162_0887440f-3c85-49c0-a2b4-acd9840fd322 54473-162 HUMAN OTC DRUG SUN SHADES 15 Lip Balm Lemon Gum Drop octinoxate and oxybenzone STICK TOPICAL 20071001 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. OCTINOXATE; OXYBENZONE 75; 30 mg/g; mg/g 54473-164_14c560f4-08f8-4f3a-9eed-3014820bfd78 54473-164 HUMAN OTC DRUG Sun Shades Mineral Plus Sunscreen Octisalate and Zinc Oxide CREAM TOPICAL 20090501 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. OCTISALATE; ZINC OXIDE 9.225; 18.45 g/177mL; g/177mL 54473-166_2a4002de-5be9-42b1-aef9-2d4223e95f04 54473-166 HUMAN OTC DRUG CounterAct Allergy Loratadine TABLET ORAL 20080628 ANDA ANDA075209 Melaleuca, Inc. LORATADINE 10 mg/1 54473-168_967dad22-e802-4c24-86ea-a24a0297a4a7 54473-168 HUMAN OTC DRUG Sun Shades Lip Balm Pomegranate SPF 15 Octinoxate and Oxybenzone STICK TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. OCTINOXATE; OXYBENZONE 75; 30 mg/g; mg/g 54473-174_22e7a4e4-595f-49e7-8380-ee3cce81200e 54473-174 HUMAN OTC DRUG SPF 15 Fair TITANIUM DIOXIDE POWDER TOPICAL 20100915 OTC MONOGRAPH FINAL part352 Melaleuca, Inc. TITANIUM DIOXIDE .7 g/10g 54473-175_5bf641c7-b807-4b6a-a1e4-df2efc961a95 54473-175 HUMAN OTC DRUG SPF 15 Light TITANIUM DIOXIDE POWDER TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. TITANIUM DIOXIDE .7 g/10g 54473-176_b3c10e1a-4d87-45e1-8e8e-90fed0f8657e 54473-176 HUMAN OTC DRUG SPF 15 Medium TITANIUM DIOXIDE POWDER TOPICAL 20100915 OTC MONOGRAPH FINAL part352 Melaleuca, Inc. TITANIUM DIOXIDE .7 g/10g 54473-177_0bccf51f-0856-43d0-a3d9-a04c6cb9a673 54473-177 HUMAN OTC DRUG SPF 15 Warm Tan TITANIUM DIOXIDE POWDER TOPICAL 20100915 OTC MONOGRAPH FINAL part352 Melaleuca, Inc. TITANIUM DIOXIDE .7 g/10g 54473-179_ef097c87-7eae-401b-b961-81aa8b4da288 54473-179 HUMAN OTC DRUG SPF 15 Deep TITANIUM DIOXIDE POWDER TOPICAL 20100915 OTC MONOGRAPH FINAL part352 Melaleuca, Inc. TITANIUM DIOXIDE .7 g/10g 54473-180_7db048a3-6556-41d8-a5fe-b75e462d266e 54473-180 HUMAN OTC DRUG HemAway Lidocane and Phenylephrine HCL CREAM TOPICAL 20101213 OTC MONOGRAPH FINAL part346 Melaleuca, Inc. LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE 50; 2.5 mg/g; mg/g 54473-181_18a86a99-ec27-4b25-b4e2-2ddf2f0921b4 54473-181 HUMAN OTC DRUG CounterAct Pain Acetaminophen TABLET, FILM COATED ORAL 20110301 OTC MONOGRAPH FINAL part343 Melaleuca, Inc. ACETAMINOPHEN 500 mg/1 54473-182_8734fb07-17c2-4aa5-a6e6-41095c2a5a41 54473-182 HUMAN OTC DRUG CounterAct PM Acetaminophen and Diphenhydramine TABLET ORAL 20110401 OTC MONOGRAPH FINAL part343 Melaleuca, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 54473-183_b559b01b-24ee-46c4-a1ff-2a63ab89f447 54473-183 HUMAN OTC DRUG CounterAct IB Ibuprofen TABLET, COATED ORAL 20110430 OTC MONOGRAPH FINAL part343 Melaleuca, Inc IBUPROFEN 200 mg/1 54473-184_7b1c2e71-7c20-4f48-be83-6f3b59f45bf9 54473-184 HUMAN OTC DRUG CounterAct Night Acetaminophen, Diphenydramine HCI, Phenylephrine HCI TABLET, COATED ORAL 20110801 OTC MONOGRAPH FINAL part341 Melaleuca, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 54473-185_4c3e5de6-2bd5-408f-94aa-d93af6cbdc74 54473-185 HUMAN OTC DRUG CounterAct Day Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine TABLET, FILM COATED ORAL 20111001 OTC MONOGRAPH FINAL part341 Melaleuca, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 54473-186_58c8da02-a1d6-492e-9bc1-c5c26fac5ec5 54473-186 HUMAN OTC DRUG Sei Bella Daytime Delivery Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .9; 3; 1.5; .93; .9 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL 54473-187_deeaf705-bf52-46a4-81a8-4d36cbbdb046 54473-187 HUMAN OTC DRUG Sei Bella Daytime Delivery avobenzone, homosalate, octisalate, ocrylene and oxybenzone LOTION TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .9018; 3.006; 1.503; .9319; .9018 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL 54473-188_9409ac74-864b-4c54-9a92-14adf0f70423 54473-188 HUMAN OTC DRUG Whitening Tooth Polish Sodium Fluoride PASTE TOPICAL 20100401 OTC MONOGRAPH FINAL part355 Melaleuca, Inc. SODIUM FLUORIDE .26244 g/108g 54473-203_b35ee7ff-3053-4588-a68d-becc276e0098 54473-203 HUMAN OTC DRUG Calmicid AC Acid Reducer Loratadine TABLET, FILM COATED ORAL 20110120 ANDA ANDA090283 Melaleuca, Inc. FAMOTIDINE 20 mg/1 54473-204_888a65ac-6a06-4065-abf3-0491e586aaf6 54473-204 HUMAN OTC DRUG koala pals berrylicious Sodium Fluoride PASTE, DENTIFRICE TOPICAL 20100401 OTC MONOGRAPH FINAL part355 Melaleuca, Inc. SODIUM FLUORIDE .2592 g/108g 54473-205_8b6e3ddd-a186-451d-9325-33955d161a7c 54473-205 HUMAN OTC DRUG Sensitive Tooth Polish Potassium Nitrate and Sodium Fluoride PASTE, DENTIFRICE TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part356 Melaleuca, Inc. POTASSIUM NITRATE; SODIUM FLUORIDE 5.4; .26244 g/108g; g/108g 54473-206_6354bcb4-fef2-40c1-ac9b-6cda56e038ee 54473-206 HUMAN OTC DRUG Dermatin Antifungal CLOTRIMAZOLE CREAM TOPICAL 20111219 OTC MONOGRAPH FINAL part333C Melaleuca, Inc. CLOTRIMAZOLE .01 g/g 54473-208_71b673cb-b7c9-4c48-b80a-f2a01c55250e 54473-208 HUMAN OTC DRUG BreathAway Mouth Rinse Cinnamon Cetylpyridinium Chloride MOUTHWASH TOPICAL 20110502 OTC MONOGRAPH NOT FINAL part356 Melaleuca, Inc. CETYLPYRIDINIUM CHLORIDE .3394 g/473mL 54473-209_ec87c443-b19c-4a72-a158-8762b70f06fd 54473-209 HUMAN OTC DRUG BreathAway Mouth Rinse Fresh Mint Cetylpyridinium Chloride MOUTHWASH TOPICAL 20110502 OTC MONOGRAPH NOT FINAL part356 Melaleuca, Inc. CETYLPYRIDINIUM CHLORIDE .3394 g/473mL 54473-210_bef2b340-1209-4767-8189-1743b5dcdf7d 54473-210 HUMAN OTC DRUG Sun Shades 15 Lip Balm Blueberry Cheesecake Octinoxate and Oxybenzone STICK TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. OCTINOXATE; OXYBENZONE 75; 30 mg/g; mg/g 54473-212_0c735b37-5321-4523-99fa-f62acba87672 54473-212 HUMAN OTC DRUG Sun Shades Sport Plus Avobenzone, Homosalate, Octisalate, Octocrylene SPRAY TOPICAL 20110430 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 4.7106; 25.553; 7.851; 15.702 g/177mL; g/177mL; g/177mL; g/177mL 54473-214_40178b2f-76fc-4c8f-bd6e-3683bd0e9502 54473-214 HUMAN OTC DRUG Sun Shades Lip Balm Butter Rum Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20121001 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g 54473-215_cc3c3b14-4255-48af-b159-006dd18b147b 54473-215 HUMAN OTC DRUG Sun Shades Lip Balm Caramel Toffee Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20121001 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g 54473-217_9348e193-f6dc-4fcb-b265-ada5c5b28ee0 54473-217 HUMAN OTC DRUG Sun Shades Lip Balm Strawberry Daiquiri Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g 54473-218_0081ac43-6c70-4ed9-862c-c3678f43f20b 54473-218 HUMAN OTC DRUG Sun Shades Mineral Plus Sunscreen with Zinc Oxide OCTISALATE 5%, OCTOCRYlENE 3%, ZINC OXIDE 10.5% LOTION TOPICAL 20121227 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTISALATE; OCTOCRYLENE; ZINC OXIDE 9.225; 5.535; 18.45 g/177mL; g/177mL; g/177mL 54473-219_b70e66c8-e775-4957-a768-db96b430410d 54473-219 HUMAN OTC DRUG Sun Shades Lip Balm Vanilla Bean Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g 54473-220_c0f77434-4cd8-4a23-8a9b-199fb1663e87 54473-220 HUMAN OTC DRUG Sun Shades Lip Balm Mountain Mint Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g 54473-221_054983e5-faf3-43cc-992d-87f4bdfa0c90 54473-221 HUMAN OTC DRUG Clarity Clear Skin Essentials Deep-Cleaning Astringent SALICYLIC ACID LIQUID TOPICAL 20120913 OTC MONOGRAPH FINAL part333D Melaleuca, Inc. SALICYLIC ACID .623 g/130mL 54473-222_f432fa28-358b-4bc1-915d-2f22111c4d70 54473-222 HUMAN OTC DRUG Clarity Clear Skin Essentials Foaming Cleanser SALICYLIC ACID LIQUID TOPICAL 20120913 OTC MONOGRAPH FINAL part333D Melaleuca, Inc. SALICYLIC ACID .691 g/133mL 54473-223_2d72a9b9-3680-4196-986c-d7bdeee8a3a5 54473-223 HUMAN OTC DRUG Clarity Clear Skin Essentials Acne treatment SALICYLIC ACID CREAM TOPICAL 20120913 OTC MONOGRAPH FINAL part333D Melaleuca Inc. SALICYLIC ACID .28 g/14g 54473-224_20a327ba-08cb-4727-80a0-25201ce4f9e9 54473-224 HUMAN OTC DRUG Affinia Facial Moisturizer AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20120801 OTC MONOGRAPH FINAL part352 Melaleuca, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.1888; 7.296; 3.648; 6.08 g/120mL; g/120mL; g/120mL; g/120mL 54473-225_af77b589-e3e6-4b6a-bdee-48af76b73165 54473-225 HUMAN OTC DRUG Clarity Clear Skin Essentials Acne Spot Treatment SALICYLIC ACID CREAM TOPICAL 20120913 OTC MONOGRAPH FINAL part333D Melaleuca Inc. SALICYLIC ACID .156 g/8.9mL 54473-226_14053139-b0ff-4c92-a424-31f854704127 54473-226 HUMAN OTC DRUG Sun Shades Lip Balm Pina Colada Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g 54473-227_e4aa4d77-561f-4f66-89da-a18b51f343d8 54473-227 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Almond Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL 54473-228_7f507b5b-d366-4db5-baa8-1a84b9bdb111 54473-228 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Beige Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL 54473-229_b4b6cf34-f587-4fee-b8d1-ff7e71ea0b84 54473-229 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Cashmere Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL 54473-230_93748db7-e35d-4994-a49a-2024a6d00608 54473-230 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Chestnut Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL 54473-231_0f7dc9ed-652a-46d9-890d-5cc9df3fb778 54473-231 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Classic Beige Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL 54473-232_4cf384ac-ffcf-4b43-a825-40b4b6286d37 54473-232 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Espresso Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL 54473-233_ba5c46a9-89ef-4968-92c9-9f31349f41f9 54473-233 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Fawn Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL 54473-234_8d798921-7ded-4799-9277-f1f34b9bf7b5 54473-234 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Golden Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL 54473-235_c7a0484d-4faf-41b9-9d39-31601a9727e1 54473-235 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Ivory Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL 54473-236_0dba512d-2aaf-4be1-a167-a41915b0fd1c 54473-236 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Natural Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL 54473-237_0ca2e191-6cd2-45f7-93de-6c490e01ecbb 54473-237 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Porcelain Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL 54473-238_378df598-56f2-4f2f-b4dd-c388136b13b8 54473-238 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Sand Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL 54473-239_ffa21c02-a979-412b-a07b-958f14835a0c 54473-239 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Toffee Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL 54473-241_9b22fab6-6af9-4ba1-8fd1-ef10aa97575d 54473-241 HUMAN OTC DRUG Sheer Confidence Antiperspirant Deodorant Moonlit Orchid Aluminum zirconium tetrachlorohydrex gly (19% Anhydrous) STICK TOPICAL 20130501 OTC MONOGRAPH FINAL part350 Melaleuca Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/57g 54473-242_3b9637fe-8f10-46ca-8887-13e74243f958 54473-242 HUMAN OTC DRUG Sheer Confidence Antiperspirant Deodorant aribbean Sunset Aluminum zirconium tetrachlorohydrex gly (19% Anhydrous) STICK TOPICAL 20130501 OTC MONOGRAPH FINAL part350 Melaleuca Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 10.83 g/57g 54473-243_b8bdc898-beea-482a-8c11-16ef80f29d68 54473-243 HUMAN OTC DRUG Sheer Confidence Antiperspirant Deodorant Perfect Powder Aluminum zirconium tetrachlorohydrex gly (19% Anhydrous) STICK TOPICAL 20130501 OTC MONOGRAPH FINAL part350 Melaleuca Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/57g 54473-244_89623eb0-745a-432a-afa0-1ca27bcfcf5b 54473-244 HUMAN OTC DRUG Sun Shades Lip Balm Sugar and Spice Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g 54473-245_05624987-1c67-4cc9-bad6-0757a506bd1b 54473-245 HUMAN OTC DRUG Sun Shades Lip Balm Peach Mango Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g 54473-246_c8169cea-60ee-48c6-915d-ecc7038b03db 54473-246 HUMAN OTC DRUG Sun Shades Lip Balm Watermelon Lemon Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g 54473-247_7384e471-b97e-4b83-892b-42b12d69ef51 54473-247 HUMAN OTC DRUG Sei Bella Skin Refining Tinted Moisturizer Procelain Titanium Dioxide LOTION TOPICAL 20130601 OTC MONOGRAPH FINAL part352 Melaleuca Inc. TITANIUM DIOXIDE 2.866 g/44.4mL 54473-248_e99547a1-a44b-45e5-ada9-90321c09d4d8 54473-248 HUMAN OTC DRUG Sei Bella Skin Refining Tinted Moisturizer Classic Beige Titanium Dioxide LOTION TOPICAL 20130601 OTC MONOGRAPH FINAL part352 Melaleuca Inc. TITANIUM DIOXIDE 2.866 g/44.4mL 54473-249_9b617e39-2ebc-4e49-890f-4baeea7ca526 54473-249 HUMAN OTC DRUG Sei Bella Skin Refining Tinted Moisturizer Fawn Titanium Dioxide LOTION TOPICAL 20130601 OTC MONOGRAPH FINAL part352 Melaleuca Inc. TITANIUM DIOXIDE 2.866 g/44.4mL 54473-250_9aa1c49f-bbfc-4652-859c-0d82f43afb45 54473-250 HUMAN OTC DRUG Sei Bella Skin Refining Tinted Moisturizer Natural Titanium Dioxide LOTION TOPICAL 20130601 OTC MONOGRAPH FINAL part352 Melaleuca Inc. TITANIUM DIOXIDE 2.866 g/44.4mL 54473-251_3b019caa-1834-4f15-bd75-234851e86fdc 54473-251 HUMAN OTC DRUG Sei Bella Skin Refining Tinted Moisturizer Tan Titanium Dioxide LOTION TOPICAL 20130601 OTC MONOGRAPH FINAL part352 Melaleuca Inc. TITANIUM DIOXIDE 2.866 g/44.4mL 54473-254_c7e58acc-fd69-4c28-9028-0094684e1fb6 54473-254 HUMAN OTC DRUG Sun Shades Lip Balm Strawberry Tart Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g 54473-255_cd631e08-f74a-499c-8e5d-9164f9ea5f4f 54473-255 HUMAN OTC DRUG Sun Shades Lip Balm STropical Fruit Sorbet Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g 54473-256_0cc1a4b4-ee2c-4379-a987-3b206b245a54 54473-256 HUMAN OTC DRUG Sun Shades Lip Balm Pink Grapefruit Avobenzone, Octinoxate, Oxybenzone STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g 54473-257_2d1f38b6-0d31-454c-a37c-2cf781514d5d 54473-257 HUMAN OTC DRUG Sun Shades Lip Balm Key Lime Pie Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g 54473-258_244e2a79-cfb4-4c82-acbd-43942a9c1e6c 54473-258 HUMAN OTC DRUG Clear Defense Citrus Sage Ethyl alcohol GEL TOPICAL 20140515 OTC MONOGRAPH NOT FINAL part333A Melaleuca Inc ALCOHOL 36.58 g/59mL 54473-578_91649003-07b6-4620-a513-dcd1edc3ae32 54473-578 HUMAN OTC DRUG Triple Antibiotic Bacitracin zinc and Neomycin and Polymyxin B sulfate OINTMENT TOPICAL 19950701 OTC MONOGRAPH FINAL part333B Melaleuca, Inc. BACITRACIN ZINC; NEOMYCIN; POLYMYXIN B SULFATE 500; 3.5; 10000 [iU]/g; mg/g; [iU]/g 54476-100_4d859414-bd74-4b2e-9f42-e2de329af2b6 54476-100 HUMAN OTC DRUG Hidocomo Antiseptic Disinfectant CHLOROXYLENOL LIQUID TOPICAL 20130117 OTC MONOGRAPH NOT FINAL part333E Toma Biotechnology International Corporation-China Division CHLOROXYLENOL 3.5 g/100mL 54482-020_de75d1c1-aeda-4229-bc48-60fde9c68f1f 54482-020 HUMAN PRESCRIPTION DRUG CYSTARAN cysteamine hydrochloride SOLUTION OPHTHALMIC 20121230 NDA NDA200740 Sigma-Tau Pharmaceuticals, Inc. CYSTEAMINE HYDROCHLORIDE 6.5 mg/mL Cystine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA] 54482-053_96d306b0-a0ee-4d3b-a7ab-d8479fd5d4ac 54482-053 HUMAN PRESCRIPTION DRUG Matulane procarbazine hydrochloride CAPSULE ORAL 19851227 NDA NDA016785 Sigma-Tau Pharmaceuticals, Inc. PROCARBAZINE HYDROCHLORIDE 50 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 54482-144_b69697d2-06cb-4827-8616-3491475eeb5a 54482-144 HUMAN PRESCRIPTION DRUG Carnitor levocarnitine TABLET ORAL 19851227 NDA NDA018948 Sigma-Tau Pharmaceuticals, Inc. LEVOCARNITINE 330 mg/1 Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] 54482-145_039a5ee7-9016-4667-a747-3d8c18d6c781 54482-145 HUMAN PRESCRIPTION DRUG Carnitor levocarnitine SOLUTION ORAL 19860410 NDA NDA019257 Sigma-Tau Pharmaceuticals, Inc. LEVOCARNITINE 1 g/10mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] 54482-147_b06f9eaa-7029-406f-8e10-e6c508237872 54482-147 HUMAN PRESCRIPTION DRUG Carnitor levocarnitine INJECTION, SOLUTION INTRAVENOUS 19921216 NDA NDA020182 Sigma-Tau Pharmaceuticals, Inc. LEVOCARNITINE 1 g/5mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] 54482-148_9cd07ff7-9a19-421c-b0e9-bfe84747a2f5 54482-148 HUMAN PRESCRIPTION DRUG Carnitor SF levocarnitine SOLUTION ORAL 19860410 NDA NDA019257 Sigma-Tau Pharmaceuticals, Inc. LEVOCARNITINE 1 g/10mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] 54482-301_ed8ba5af-1ac1-4aa8-a685-230d69a1a2b3 54482-301 HUMAN PRESCRIPTION DRUG Oncaspar pegaspargase INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19940201 BLA BLA103411 Sigma-Tau Pharmaceuticals, Inc. PEGASPARGASE 750 [iU]/mL Asparaginase [Chemical/Ingredient],Asparagine-specific Enzyme [EPC] 54483-0001_29c43bba-5511-495a-a108-6603acddcf61 54483-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19860506 UNAPPROVED MEDICAL GAS Air-Way Medical, Inc. OXYGEN 99 L/100L 54494-001_77ed99ad-54c1-4eb8-8cf2-a6e9a21d4f5c 54494-001 HUMAN OTC DRUG E MEI SHAN MEDICATED PLASTER Camphor, Menthol, Methyl Salicylate PLASTER TRANSDERMAL 20130219 OTC MONOGRAPH NOT FINAL part348 CHENGDU RONGYAO GROUP SICHUAN CHANGWEI PHARMACEUTICAL CO., LTD. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3.1; 2.6; 10.1 g/1; g/1; g/1 54505-101_d11d6c8a-8e71-4347-b6d0-1900dc438c3e 54505-101 HUMAN PRESCRIPTION DRUG epinephrine epinephrine INJECTION SUBCUTANEOUS 20100401 NDA AUTHORIZED GENERIC NDA020800 Lineage Therapeutics Inc. EPINEPHRINE .15 mg/.15mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 54505-102_d11d6c8a-8e71-4347-b6d0-1900dc438c3e 54505-102 HUMAN PRESCRIPTION DRUG epinephrine epinephrine INJECTION SUBCUTANEOUS 20100401 NDA AUTHORIZED GENERIC NDA020800 Lineage Therapeutics Inc. EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 54505-327_1e878005-672e-11e3-949a-0800200c9a66 54505-327 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Extended-Release Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 19760802 NDA AUTHORIZED GENERIC NDA017078 Lineage Therapeutics DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54505-328_1e878005-672e-11e3-949a-0800200c9a66 54505-328 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Extended-Release Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 19760802 NDA AUTHORIZED GENERIC NDA017078 Lineage Therapeutics DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54505-329_1e878005-672e-11e3-949a-0800200c9a66 54505-329 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Extended-Release Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 19760802 NDA AUTHORIZED GENERIC NDA017078 Lineage Therapeutics DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54505-331_2dec7772-ddbf-11e2-a28f-0800200c9a66 54505-331 HUMAN PRESCRIPTION DRUG HYDROCORTISONE hydrocortisone TABLET ORAL 20070330 ANDA ANDA040646 Lineage Therapeutics Inc HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54505-332_2dec7772-ddbf-11e2-a28f-0800200c9a66 54505-332 HUMAN PRESCRIPTION DRUG HYDROCORTISONE hydrocortisone TABLET ORAL 20070330 ANDA ANDA040646 Lineage Therapeutics Inc HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54505-333_2dec7772-ddbf-11e2-a28f-0800200c9a66 54505-333 HUMAN PRESCRIPTION DRUG HYDROCORTISONE hydrocortisone TABLET ORAL 20070330 ANDA ANDA040646 Lineage Therapeutics Inc HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54528-001_0720d9e2-5884-3631-e054-00144ff8d46c 54528-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20141031 UNAPPROVED MEDICAL GAS Commonwealth Home Health Care, Inc. OXYGEN 995 mL/L 54531-100_c0dda789-4173-431d-9d0a-8648da6e0c91 54531-100 HUMAN PRESCRIPTION DRUG Minocin minocycline hydrochloride INJECTION INTRAVENOUS 20130419 NDA NDA050444 Rempex Pharmaceuticals, Inc MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 54532-0010_8b099d44-8381-4878-a17c-8ac49a136164 54532-0010 HUMAN OTC DRUG Hevert Stress Relief BLACK COHOSH, ANAMIRTA COCCULUS SEED, CYPRIPEDIUM PARVIFOLUM ROOT, STRYCHNOS IGNATII SEED, LILIUM LANCIFOLIUM FLOWERING TOP, PASSIFLORA INCARNATA FLOWERING TOP, PLATINUM, VALERIAN, and ZINC VALERATE DIHYDRATE TABLET ORAL 20130215 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC ANAMIRTA COCCULUS SEED; BLACK COHOSH; CYPRIPEDIUM PARVIFOLUM ROOT; LILIUM LANCIFOLIUM FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; PLATINUM; STRYCHNOS IGNATII SEED; VALERIAN; ZINC VALERATE DIHYDRATE 6; 4; 6; 6; 3; 8; 6; 2; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54532-0012_347ef374-ac54-4fda-b975-f528c41b8524 54532-0012 HUMAN OTC DRUG Hevert Allergy Relief APIS MELLIFERA, GALPHIMIA GLAUCA WHOLE, POTASSIUM DICHROMATE, TEUCRIUM MARUM TOP, and VERBASCUM DENSIFLORUM FLOWERING TOP TABLET ORAL 20130201 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC APIS MELLIFERA; GALPHIMIA GLAUCA WHOLE; POTASSIUM DICHROMATE; TEUCRIUM MARUM TOP; VERBASCUM DENSIFLORUM FLOWERING TOP 4; 4; 6; 4; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54532-0013_2da94074-d767-4c2b-bf79-696043de9915 54532-0013 HUMAN OTC DRUG Hevert Motion Sickness Relief ANAMIRTA COCCULUS SEED, CONIUM MACULATUM FLOWERING TOP, and TOBACCO LEAF TABLET ORAL 20130201 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; TOBACCO LEAF 4; 6; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 54532-0014_0b4d297b-0da0-4aea-b363-4c6924298fb0 54532-0014 HUMAN OTC DRUG Hevert Pain Relief ARNICA MONTANA ROOT and TOXICODENDRON PUBESCENS SHOOT TABLET ORAL 20130215 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC ARNICA MONTANA ROOT; TOXICODENDRON PUBESCENS SHOOT 4; 6 [hp_X]/1; [hp_X]/1 54532-0015_4395d337-75e6-431e-a5b7-cb6a3916ec4b 54532-0015 HUMAN OTC DRUG Hevert Cough Relief DROSERA ROTUNDIFOLIA, DROSERA INTERMEDIA, DROSERA ANGLICA, ERIODICTYON CALIFORNICUM FLOWERING TOP, GRINDELIA HIRSUTULA FLOWERING TOP, POTASSIUM IODIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, LOBARIA PULMONARIA, TEUCRIUM SCORODONIA FLOWERING TOP, and VERBASCUM DENSIFLORUM FLOWERING TOP TABLET ORAL 20130307 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC DROSERA ANGLICA; DROSERA INTERMEDIA; DROSERA ROTUNDIFOLIA; ERIODICTYON CALIFORNICUM FLOWERING TOP; GRINDELIA HIRSUTULA FLOWERING TOP; LOBARIA PULMONARIA; POTASSIUM IODIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; TEUCRIUM SCORODONIA FLOWERING TOP; VERBASCUM DENSIFLORUM FLOWERING TOP 4; 4; 4; 2; 4; 3; 3; 4; 3; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54532-0016_bff083b4-c58d-49d6-85b4-0214ea081a35 54532-0016 HUMAN OTC DRUG Hevert Cold and Flu Relief ACONITUM NAPELLUS, AMMONIUM BROMIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, CINCHONA OFFICINALIS BARK, ECHINACEA, UNSPECIFIED, MERCURIC CYANIDE, and TOXICODENDRON PUBESCENS SHOOT TABLET ORAL 20130510 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC ACONITUM NAPELLUS; AMMONIUM BROMIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; MERCURIC CYANIDE; TOXICODENDRON PUBESCENS SHOOT 6; 4; 6; 6; 6; 3; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54532-0018_e6fb8472-a338-4690-a395-22ec765b00cd 54532-0018 HUMAN OTC DRUG Hevert Detox Intestinum Eichhornia Crassipes Whole, OKOUBAKA AUBREVILLEI BARK, QUASSIA AMARA WOOD, and TARAXACUM PALUSTRE ROOT LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC EICHHORNIA CRASSIPES WHOLE; OKOUBAKA AUBREVILLEI BARK; QUASSIA AMARA WOOD; TARAXACUM PALUSTRE ROOT 1; 2; 1; 1 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 54532-0019_b12aa055-00a8-4b69-b601-4234fcea1b12 54532-0019 HUMAN OTC DRUG Hevert Detox Kidney Nitric Acid, Apis Cerana Whole, Atropa Belladonna, Lytta Vesicatoria, Juniperus Communis Whole, and Solidago Virgaurea Flowering Top LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC APIS CERANA WHOLE; ATROPA BELLADONNA; JUNIPERUS COMMUNIS WHOLE; LYTTA VESICATORIA; NITRIC ACID; SOLIDAGO VIRGAUREA FLOWERING TOP 3; 6; 3; 4; 6; 1 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 54532-0020_7b8c20ad-40da-4cd4-84cc-caa12f68707a 54532-0020 HUMAN OTC DRUG Hevert Detox Liver Milk Thistle, Chelidonium Majus Root, and Taraxacum Palustre Root LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC CHELIDONIUM MAJUS ROOT; MILK THISTLE; TARAXACUM PALUSTRE ROOT 3; 1; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 54532-0021_c03112f2-4c6e-4f31-aa80-8b1ebc492d0a 54532-0021 HUMAN OTC DRUG Hevert Detox Lymph Arsenic Trioxide, Clematis Recta Flowering top, Conium Maculatum Flowering Top, Lachesis Muta Venom, Mercuric Iodide, Phytolacca Americana Root, Toxicodendron Pubescens Leaf, Scrophularia Nodosa, and Sulfur LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC ARSENIC TRIOXIDE; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; LACHESIS MUTA VENOM; MERCURIC IODIDE; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SULFUR; TOXICODENDRON PUBESCENS LEAF 6; 4; 6; 8; 8; 4; 3; 4; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 54557-0001_ec5f6bed-f368-42e7-94fa-b91b36aed9b4 54557-0001 HUMAN OTC DRUG ARTHRITIS CARE Colchicum Autumnale, Propolis, Kalmia Latifolia, Bryonia, Causticum, Kali Carbonicum, Ledum Palustre, Rhododendron Chrysanthum, GEL TOPICAL 20130809 UNAPPROVED HOMEOPATHIC MedCare Group LLC BRYONIA ALBA ROOT; CAUSTICUM; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; POTASSIUM CARBONATE; PROPOLIS WAX; RHODODENDRON AUREUM LEAF; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 6; 12; 6; 6; 12; 12; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54557-0002_49d48a78-c01f-49bf-aa80-354351f2cf23 54557-0002 HUMAN OTC DRUG Bruises Gone Gel Calendula Officinalis, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Sulphuricum Acidum GEL TOPICAL 20130808 UNAPPROVED HOMEOPATHIC MedCare Group LLC ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE; SULFURIC ACID; TOXICODENDRON PUBESCENS LEAF 1; 12; 30; 1; 3; 30; 1; 12; 30; 30; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 54557-0003_6eaf781f-f407-45ed-af51-78cc01dff2e9 54557-0003 HUMAN OTC DRUG Nasal Guard Ammonium Carbonicum, Arsenicum Album, hepar Sulphuris Calcareum, Iodium, Lycopodium Clavatum, Nux Vomica, Pulsatilla, LIQUID NASAL 20130827 UNAPPROVED HOMEOPATHIC Medcare Group LLC AMMONIUM CARBONATE; ARSENIC TRIOXIDE; CALCIUM SULFIDE; IODINE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54569-0005_11728279-53b0-4398-9e1c-ea93c82b9be9 54569-0005 HUMAN OTC DRUG aspirin regular strength regular strength Aspirin TABLET ORAL 20060524 OTC MONOGRAPH FINAL part343 A-S Medication Solutions LLC ASPIRIN 325 mg/1 54569-0014_4b96c23c-ec0e-4fa3-a226-68ffa2ceba41 54569-0014 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength TABLET ORAL 20110204 OTC MONOGRAPH FINAL part343 A-S Medication Solutions LLC ASPIRIN 325 mg/1 54569-0023_9df05cfb-9ecc-4370-b717-54c8c3f3d1a1 54569-0023 HUMAN OTC DRUG TYLENOL Extra Strength Acetaminophen TABLET, COATED ORAL 19840819 OTC MONOGRAPH NOT FINAL part343 A-S Medication Solutions LLC ACETAMINOPHEN 500 mg/1 54569-0024_a5522538-e459-4b54-84bd-164fe4c5dee3 54569-0024 HUMAN PRESCRIPTION DRUG TYLENOL with Codeine acetaminophen and codeine phosphate TABLET ORAL 19861010 ANDA ANDA085055 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 54569-0025_cec9ac46-ae10-4628-a432-8f9a792c88a1 54569-0025 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 54569-0075_f2e6084e-8fef-4cbf-b6c7-173d93ba2573 54569-0075 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20070125 ANDA ANDA078060 A-S Medication Solutions LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 54569-0084_83f9dc38-a96c-46ed-a794-40ebbdb3dad4 54569-0084 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19870218 ANDA ANDA071293 A-S Medication Solutions LLC AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 54569-0117_afd5ec91-5195-4e9e-af9c-e0434e137728 54569-0117 HUMAN PRESCRIPTION DRUG AUGMENTIN amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050575 A-S Medication Solutions LLC AMOXICILLIN; CLAVULANATE POTASSIUM 250; 62.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54569-0118_9444cb51-4ea1-4b2d-80d9-deee7fd1fbf7 54569-0118 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 19830202 ANDA ANDA062421 A-S Medication Solutions LLC DOXYCYCLINE HYCLATE 100 mg/1 54569-0124_34c016a7-4107-4634-8b2f-74a408109fe3 54569-0124 HUMAN PRESCRIPTION DRUG Erythrocin Stearate ERYTHROMYCIN STEARATE TABLET, FILM COATED ORAL 20110801 ANDA ANDA060359 A-S Medication Solutions LLC ERYTHROMYCIN STEARATE 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54569-0126_d16f0053-62b1-4ee4-8fb1-635a66aa9d4e 54569-0126 HUMAN PRESCRIPTION DRUG E.E.S Erythromycin Ethylsuccinate GRANULE, FOR SUSPENSION ORAL 20110418 NDA NDA050207 A-S Medication Solutions LLC ERYTHROMYCIN ETHYLSUCCINATE 200 mg/5mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54569-0147_d104c89a-d3ef-4018-9ae6-4e5dd468e87c 54569-0147 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19860710 ANDA ANDA062676 A-S Medication Solutions LLC DOXYCYCLINE HYCLATE 50 mg/1 54569-0158_dfb61538-1af9-4bd5-a407-ae696d88f7ac 54569-0158 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 A-S Medication Solutions LLC WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54569-0159_dfb61538-1af9-4bd5-a407-ae696d88f7ac 54569-0159 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 A-S Medication Solutions LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54569-0161_c72b63e4-47b1-4885-8327-57620863ffbe 54569-0161 HUMAN PRESCRIPTION DRUG Dilantin PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 19760827 ANDA ANDA084349 A-S Medication Solutions LLC PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54569-0172_d7b1e1db-d96d-4b44-9dc6-ca1cd12f51bf 54569-0172 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 A-S Medication Solutions LLC AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 54569-0175_d7b1e1db-d96d-4b44-9dc6-ca1cd12f51bf 54569-0175 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 A-S Medication Solutions LLC AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 54569-0181_48cdd99c-0965-4de9-b4de-1af451e99de4 54569-0181 HUMAN PRESCRIPTION DRUG Nitrofurantoin (macrocrystals) nitrofurantoin (macrocrystals) CAPSULE ORAL 20121024 ANDA ANDA074967 A-S Medication Solutions LLC NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 54569-0194_d0cb2ef3-8741-4a2f-81e0-ecffeea7b71d 54569-0194 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19900605 ANDA ANDA081049 A-S Medication Solutions LLC IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 54569-0197_6b11ddab-632d-49e5-9a4e-bbc17a57a7bd 54569-0197 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl Phenazopyridine HCl TABLET ORAL 20100910 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 54569-0199_6b11ddab-632d-49e5-9a4e-bbc17a57a7bd 54569-0199 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl Phenazopyridine HCl TABLET ORAL 20100910 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 54569-0222_43baf8f3-2f97-4408-adc3-7c5857c7ecc7 54569-0222 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 A-S Medication Solutions LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 54569-0233_99b98a35-6c9e-4e47-944f-247fe81267b5 54569-0233 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 A-S Medication Solutions LLC ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 54569-0235_99b98a35-6c9e-4e47-944f-247fe81267b5 54569-0235 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 A-S Medication Solutions LLC ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 54569-0239_e9726281-9273-44ab-bcd6-9a828a986c7a 54569-0239 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 54569-0241_710f7015-3dac-4926-b9ce-c1fa96dbafc5 54569-0241 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 54569-0243_0e333585-4529-4fea-b9fd-b3b8dd830769 54569-0243 HUMAN OTC DRUG Allergy Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC CHLORPHENIRAMINE MALEATE 4 mg/1 54569-0285_94b4d48e-db4d-4026-a13f-9f79661efefc 54569-0285 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 A-S Medication Solutions LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54569-0287_94b4d48e-db4d-4026-a13f-9f79661efefc 54569-0287 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 A-S Medication Solutions LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54569-0289_94b4d48e-db4d-4026-a13f-9f79661efefc 54569-0289 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 A-S Medication Solutions LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54569-0294_a1b8c3f3-356a-4e3c-a612-661d69631cd3 54569-0294 HUMAN PRESCRIPTION DRUG Naprosyn naproxen TABLET ORAL 19760311 NDA NDA017581 A-S Medication Solutions LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54569-0302_3c525ad3-8ccb-4310-b385-79bed00a62ba 54569-0302 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089828 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 54569-0304_f4c46e6c-404a-4823-8437-2f4a1c0ff6bd 54569-0304 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110120 ANDA ANDA090836 A-S Medication Solutions LLC CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54569-0305_f4c46e6c-404a-4823-8437-2f4a1c0ff6bd 54569-0305 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110120 ANDA ANDA090836 A-S Medication Solutions LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54569-0311_0810f2ba-b4cb-4e65-b819-31791d5670dc 54569-0311 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089990 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 54569-0313_a3c02e2b-b6fe-46cc-8cfd-3950dba29c89 54569-0313 HUMAN PRESCRIPTION DRUG Sulfasalazine SULFASALAZINE TABLET ORAL 20030701 NDA AUTHORIZED GENERIC NDA007073 A-S Medication Solutions LLC SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 54569-0322_d7c4676c-f865-4bc5-89bd-358d53e65fd1 54569-0322 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750603 ANDA ANDA084613 A-S Medication Solutions LLC DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-0324_d7c4676c-f865-4bc5-89bd-358d53e65fd1 54569-0324 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 A-S Medication Solutions LLC DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-0327_bd47f3e5-58ff-4cf3-86bc-e5740d79c5d7 54569-0327 HUMAN PRESCRIPTION DRUG Medrol METHYLPREDNISOLONE TABLET ORAL 19571024 NDA NDA011153 A-S Medication Solutions LLC METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-0330_f89b234a-4ec2-48b3-ba36-5867e512ad3c 54569-0330 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 A-S Medication Solutions LLC PREDNISONE 5 mg/1 54569-0331_f89b234a-4ec2-48b3-ba36-5867e512ad3c 54569-0331 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA084122 A-S Medication Solutions LLC PREDNISONE 10 mg/1 54569-0332_bb52388f-fa2c-4147-983f-dc90f92fa4e1 54569-0332 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19740226 ANDA ANDA083677 A-S Medication Solutions LLC PREDNISONE 20 mg/1 54569-0333_f89b234a-4ec2-48b3-ba36-5867e512ad3c 54569-0333 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030314 ANDA ANDA084283 A-S Medication Solutions LLC PREDNISONE 50 mg/1 54569-0336_d7c4676c-f865-4bc5-89bd-358d53e65fd1 54569-0336 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19820826 ANDA ANDA087916 A-S Medication Solutions LLC DEXAMETHASONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-0337_624024ba-9ec0-48f4-894a-56d6ba918daa 54569-0337 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, Caffeine and Codeine Phosphate Butalbital, Aspirin, Caffeine and Codeine Phosphate CAPSULE ORAL 20061026 NDA AUTHORIZED GENERIC NDA019429 A-S Medication Solutions LLC ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 54569-0339_aaf1c383-3002-4787-bb23-95a24dd855f0 54569-0339 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine TABLET ORAL 19790605 ANDA ANDA086162 A-S Medication Solutions LLC ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 54569-0347_a9ca5f1a-520f-427e-8c39-721ed78ff149 54569-0347 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20100212 ANDA ANDA201451 A-S Medication Solutions LLC MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 54569-0349_a9ca5f1a-520f-427e-8c39-721ed78ff149 54569-0349 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20100212 ANDA ANDA201451 A-S Medication Solutions LLC MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 54569-0350_6a5a584d-22b2-4584-88ee-857c204250f9 54569-0350 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960725 ANDA ANDA040120 A-S Medication Solutions LLC PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54569-0355_6a5a584d-22b2-4584-88ee-857c204250f9 54569-0355 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960725 ANDA ANDA040120 A-S Medication Solutions LLC PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54569-0384_4b61dfe4-4a46-4d41-8fcb-b0de2c1e5359 54569-0384 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19900930 ANDA ANDA062286 A-S Medication Solutions LLC DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-0389_6fe8784e-8081-4f4d-a6a2-af1f6f288dc0 54569-0389 HUMAN PRESCRIPTION DRUG DIDREX benzphetamine hydrochloride TABLET ORAL 19601026 NDA NDA012427 A-S Medication Solutions LLC BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 54569-0392_0c98e4c6-5a04-4659-bec3-d2925a48cdb0 54569-0392 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 A-S Medication Solutions LLC PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 54569-0396_df4f38b3-8dbc-4771-8472-7c61eda1aa63 54569-0396 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 19601117 NDA NDA012546 A-S Medication Solutions LLC DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 54569-0406_097999c9-93f1-49dc-8348-ab3642156545 54569-0406 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20050527 ANDA ANDA040579 A-S Medication Solutions LLC HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 54569-0409_097999c9-93f1-49dc-8348-ab3642156545 54569-0409 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20050527 ANDA ANDA040580 A-S Medication Solutions LLC HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 54569-0413_097999c9-93f1-49dc-8348-ab3642156545 54569-0413 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20050527 ANDA ANDA040574 A-S Medication Solutions LLC HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 54569-0417_cb24f895-b785-4919-8b38-baa8b8c49e43 54569-0417 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 A-S Medication Solutions LLC DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 54569-0419_3150a0fe-1265-4df5-a31c-602d1a089423 54569-0419 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 A-S Medication Solutions LLC DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 54569-0430_28a02251-9953-4ec7-9425-38e9d3d65d66 54569-0430 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride And Clidinium Bromide CHLORDIAZEPOXIDE HYDROCHLORIDE, CLIDINIUM BROMIDE CAPSULE ORAL 20110830 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] CIV 54569-0434_c4f0fd00-60ee-4756-8816-645deb473f0f 54569-0434 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 A-S Medication Solutions LLC METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 54569-0452_6545bcf0-9cd7-4b6d-bf27-60d3e4146eaf 54569-0452 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880407 ANDA ANDA089367 A-S Medication Solutions LLC ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 54569-0461_ed0170d6-9dc0-4e0c-889b-bbe20283a74c 54569-0461 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 A-S Medication Solutions LLC NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 54569-0478_7ce0f8e4-7c0f-4592-825c-eeb2edaa557f 54569-0478 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 A-S Medication Solutions LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54569-0502_a7f79a22-feba-4a49-931c-103aa1a8ac86 54569-0502 HUMAN PRESCRIPTION DRUG Spironolactone and Hydrochlorothiazide spironolactone and hydrochlorothiazide TABLET, FILM COATED ORAL 19780101 NDA AUTHORIZED GENERIC NDA012616 A-S Medication Solutions LLC HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 25; 25 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54569-0505_b6fd2c9a-dd76-4363-8cbd-54d2be7232c3 54569-0505 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 A-S Medication Solutions LLC SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 54569-0510_8c6f2884-d9df-4006-90f0-296d05ac64f0 54569-0510 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 20090428 ANDA ANDA070343 A-S Medication Solutions LLC METHYLDOPA 500 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54569-0515_32bff5e0-f1d7-4583-9d36-6c62a33e833e 54569-0515 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 A-S Medication Solutions LLC HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 54569-0517_32bff5e0-f1d7-4583-9d36-6c62a33e833e 54569-0517 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 A-S Medication Solutions LLC HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 54569-0547_01c60658-1930-4279-953d-142c8986b93c 54569-0547 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 A-S Medication Solutions LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54569-0549_01c60658-1930-4279-953d-142c8986b93c 54569-0549 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 A-S Medication Solutions LLC HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54569-0552_f199a114-9254-408f-872f-cbff30d20705 54569-0552 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 20120507 ANDA ANDA086831 A-S Medication Solutions LLC CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 54569-0554_f199a114-9254-408f-872f-cbff30d20705 54569-0554 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 20120507 ANDA ANDA086831 A-S Medication Solutions LLC CHLORTHALIDONE 50 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 54569-0557_8002fc52-6737-4ffe-bd81-22432b79d291 54569-0557 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070217 A-S Medication Solutions LLC PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54569-0559_8002fc52-6737-4ffe-bd81-22432b79d291 54569-0559 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070218 A-S Medication Solutions LLC PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54569-0561_8002fc52-6737-4ffe-bd81-22432b79d291 54569-0561 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070219 A-S Medication Solutions LLC PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54569-0570_4355d493-fd99-4086-af2f-6c575c46fec7 54569-0570 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 A-S Medication Solutions LLC FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 54569-0572_4a9df87c-ea48-4b64-8c42-93a6a87cb0f7 54569-0572 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 A-S Medication Solutions LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 54569-0574_4a9df87c-ea48-4b64-8c42-93a6a87cb0f7 54569-0574 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 A-S Medication Solutions LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 54569-0626_8d78d9ee-65d6-4a09-826a-78818577afc1 54569-0626 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 19941001 OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 54569-0646_9ce98220-4334-465f-82f3-a16a247a6aa8 54569-0646 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070994 A-S Medication Solutions LLC VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54569-0650_434ee84d-8987-47a9-9e6c-3634ff83e5e2 54569-0650 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET ORAL 19941001 OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 54569-0679_3fd32a8b-1ed4-4088-9e18-f4a7aa92dbdf 54569-0679 HUMAN PRESCRIPTION DRUG Lo/Ovral-28 norgestrel and ethinyl estradiol KIT 19760301 NDA NDA017802 A-S Medication Solutions LLC 54569-0689_e451dd4c-cec6-44dc-baec-12f734b8ab0f 54569-0689 HUMAN PRESCRIPTION DRUG Ortho-Novum 777 norethindrone and ethinyl estradiol KIT 19840404 NDA NDA018985 A-S Medication Solutions LLC 54569-0765_ba9aed75-4e82-453e-9539-dbbca5a272fd 54569-0765 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 A-S Medication Solutions LLC TRIAMCINOLONE ACETONIDE 1 mg/g 54569-0767_adfc2b54-d02f-4e0e-a1f4-ed98e16557da 54569-0767 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide OINTMENT TOPICAL 19780214 ANDA ANDA085691 A-S Medication Solutions LLC TRIAMCINOLONE ACETONIDE 1 mg/g 54569-0774_8e00c77f-b71f-46a8-a39e-51b2599d1fd8 54569-0774 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 19871222 ANDA ANDA062364 A-S Medication Solutions LLC NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 54569-0793_26e6294a-478b-44a8-8e6a-6afcff6840d3 54569-0793 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate OINTMENT TOPICAL 20020901 ANDA ANDA070051 A-S Medication Solutions LLC BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-0809_b078dacc-3369-43d3-b263-415b1a136281 54569-0809 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 A-S Medication Solutions LLC MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54569-0812_5b932a46-61f8-4cc3-adda-0c5faad6d1c9 54569-0812 HUMAN PRESCRIPTION DRUG Premarin ESTROGENS, CONJUGATED TABLET, FILM COATED ORAL 20060101 NDA NDA004782 A-S Medication Solutions LLC ESTROGENS, CONJUGATED .625 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 54569-0813_5b932a46-61f8-4cc3-adda-0c5faad6d1c9 54569-0813 HUMAN PRESCRIPTION DRUG Premarin ESTROGENS, CONJUGATED TABLET, FILM COATED ORAL 20040901 NDA NDA004782 A-S Medication Solutions LLC ESTROGENS, CONJUGATED 1.25 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 54569-0826_57df76a1-ed82-44f6-912f-d701ae82b864 54569-0826 HUMAN OTC DRUG Fleet sodium phosphate, dibasic and sodium phosphate, monobasic ENEMA RECTAL 20020510 OTC MONOGRAPH NOT FINAL part334 A-S Medication Solutions LLC SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/133mL; g/133mL 54569-0838_1d9f8f3f-a8e4-42dc-aa7d-a41a8a8a8fa7 54569-0838 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 A-S Medication Solutions LLC ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 54569-0843_09057de3-9cff-4595-ae51-f1f596e14aa4 54569-0843 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 A-S Medication Solutions LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 54569-0852_09057de3-9cff-4595-ae51-f1f596e14aa4 54569-0852 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 A-S Medication Solutions LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 54569-0860_d7de179e-8eb9-455f-9cb3-55a0dde9ad2f 54569-0860 HUMAN PRESCRIPTION DRUG BLEPHAMIDE sulfacetamide sodium and prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19611001 NDA NDA012813 A-S Medication Solutions LLC PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM 2; 100 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-0861_d26bbac4-d399-4759-b194-df1065f5aec8 54569-0861 HUMAN PRESCRIPTION DRUG BLEPHAMIDE sulfacetamide sodium and prednisolone acetate OINTMENT OPHTHALMIC 19870101 ANDA ANDA087748 A-S Medication Solutions LLC PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM 2; 100 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-0871_bfb3fe38-5d89-4030-8377-ec0f46f701bd 54569-0871 HUMAN PRESCRIPTION DRUG PRED FORTE prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19730601 NDA NDA017011 A-S Medication Solutions LLC PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-0898_cf836a1d-a69e-4a61-8a56-6f79827c069c 54569-0898 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 19861208 ANDA ANDA071108 A-S Medication Solutions LLC FLURAZEPAM HYDROCHLORIDE 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-0905_76743946-b94a-43b4-8d02-4747e4d95b9b 54569-0905 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 A-S Medication Solutions LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-0907_c2d0eca2-c897-4410-b987-d2829d11a093 54569-0907 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 A-S Medication Solutions LLC LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54569-0908_c2d0eca2-c897-4410-b987-d2829d11a093 54569-0908 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 A-S Medication Solutions LLC LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54569-0909_c2d0eca2-c897-4410-b987-d2829d11a093 54569-0909 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 A-S Medication Solutions LLC LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54569-0910_c2d0eca2-c897-4410-b987-d2829d11a093 54569-0910 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 A-S Medication Solutions LLC LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54569-0917_62ea9122-3580-43b2-89e2-5b64e9cc627e 54569-0917 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC THYROID, PORCINE 30 mg/1 54569-0918_62ea9122-3580-43b2-89e2-5b64e9cc627e 54569-0918 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC THYROID, PORCINE 60 mg/1 54569-0919_62ea9122-3580-43b2-89e2-5b64e9cc627e 54569-0919 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC THYROID, PORCINE 120 mg/1 54569-0927_0537cca4-625e-42ef-873c-f431ba7d630f 54569-0927 HUMAN PRESCRIPTION DRUG Ativan lorazepam TABLET ORAL 20100316 NDA NDA017794 A-S Medication Solutions LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-0936_2192bd6b-7fb0-4b2d-8fc2-494b61066b0c 54569-0936 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 A-S Medication Solutions LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-0947_3a777384-2e7e-48b5-8be9-381697a8a6f4 54569-0947 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071307 A-S Medication Solutions LLC DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-0949_23c27189-0dc2-4b9e-a23a-4fd20448cdd2 54569-0949 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 A-S Medication Solutions LLC DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-0958_c7d8678c-5b65-40f4-a527-e801c36f73b7 54569-0958 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20090609 ANDA ANDA090035 A-S Medication Solutions LLC FOLIC ACID 1 mg/1 54569-0965_5e6e8693-4b14-4abd-84eb-e358940fb1fb 54569-0965 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070027 A-S Medication Solutions LLC METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 54569-0967_8998b000-ff1f-42cd-aefe-0a9fdbbde80c 54569-0967 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110822 ANDA ANDA070044 A-S Medication Solutions LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 54569-1001_fd1b6f13-8701-4123-8341-5b03d909d43a 54569-1001 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate ACETAMINOPHEN and CODEINE PHOSPHATE SOLUTION ORAL 19810821 ANDA ANDA087508 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 54569-1018_bff28656-50ee-4ab3-8ca9-44f24b5d7fa5 54569-1018 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 19880229 ANDA ANDA062876 A-S Medication Solutions LLC NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 54569-1023_f8ade69d-c1a8-4a97-b51f-f0dcfec508e6 54569-1023 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 A-S Medication Solutions LLC CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54569-1024_f8ade69d-c1a8-4a97-b51f-f0dcfec508e6 54569-1024 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 A-S Medication Solutions LLC CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54569-1025_42856923-849e-4273-9ee6-0b5bc2331d5c 54569-1025 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 A-S Medication Solutions LLC CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54569-1036_62ce959a-23dc-4eed-826a-947e53f384a4 54569-1036 HUMAN PRESCRIPTION DRUG MethylPREDNISolone methylprednisolone TABLET ORAL 19981222 ANDA ANDA040183 A-S Medication Solutions LLC METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-1046_466f2e01-3244-4d52-a772-6c16ab45b317 54569-1046 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SYRUP ORAL 20060426 ANDA ANDA040643 A-S Medication Solutions LLC PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54569-1047_4dde2e7d-549a-4c99-b8df-59d48813deed 54569-1047 HUMAN PRESCRIPTION DRUG Promethazine VC With Codeine Codeine Phosphate, Promethazine Hydrochloride, and Phenylephrine Hydrochloride SYRUP ORAL 20061207 ANDA ANDA040660 A-S Medication Solutions LLC CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10; 5; 6.25 mg/5mL; mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] CV 54569-1051_d3af1d05-a1ed-4351-8d07-db204e07e6f7 54569-1051 HUMAN OTC DRUG Delsym Dextromethorphan SUSPENSION, EXTENDED RELEASE ORAL 20100504 NDA NDA018658 A-S Medication Solutions LLC DEXTROMETHORPHAN 30 mg/5mL 54569-1054_a41b19cd-381d-4ba5-bee7-4b8188751910 54569-1054 HUMAN PRESCRIPTION DRUG Promethazine VC Promethazinehydrochloride and phenylephrine hydrochloride SYRUP ORAL 20061207 ANDA ANDA040654 A-S Medication Solutions LLC PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 5; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 54569-1055_2c78724a-29d9-4dbb-8423-c56bb498caf5 54569-1055 HUMAN PRESCRIPTION DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL 20060214 ANDA ANDA040649 A-S Medication Solutions LLC DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54569-1056_00bd0f6f-a02e-4dce-99b5-699d9aa6d1c9 54569-1056 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20060131 ANDA ANDA040650 A-S Medication Solutions LLC CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 54569-1084_ca255b2c-f6eb-4c4c-b052-2ebc372c79cf 54569-1084 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 A-S Medication Solutions LLC TRIAMCINOLONE ACETONIDE 1 mg/g 54569-1086_64614632-b086-4706-b860-ef6373e28821 54569-1086 HUMAN PRESCRIPTION DRUG SILVADENE SILVER SULFADIAZINE CREAM TOPICAL 19731126 NDA NDA017381 A-S Medication Solutions LLC SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 54569-1088_60aa510d-3b07-4c93-b4ed-2e3dca360051 54569-1088 HUMAN PRESCRIPTION DRUG SILVADENE SILVER SULFADIAZINE CREAM TOPICAL 19731126 NDA NDA017381 A-S Medication Solutions LLC SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 54569-1096_44fe1a31-79e1-461b-a7f7-a2f6b33e5688 54569-1096 HUMAN OTC DRUG Hydrocortisone hydrocortisone CREAM TOPICAL 20011001 OTC MONOGRAPH NOT FINAL part348 A-S Medication Solutions LLC HYDROCORTISONE 10 mg/g 54569-1104_fe77a039-400c-46d5-b71f-1931f1dfb257 54569-1104 HUMAN PRESCRIPTION DRUG Nystatin Nystatin OINTMENT TOPICAL 20060915 ANDA ANDA062472 A-S Medication Solutions LLC NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 54569-1111_82c4934e-1574-4c7f-ae0e-7a3ea8c614ad 54569-1111 HUMAN OTC DRUG TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sulfate OINTMENT TOPICAL 20110601 OTC MONOGRAPH FINAL part333B A-S Medication Solutions LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 54569-1113_902d9d45-f8ba-41db-a8d2-ccbf0a1d7972 54569-1113 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 19840626 NDA NDA019137 A-S Medication Solutions LLC BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-1114_902d9d45-f8ba-41db-a8d2-ccbf0a1d7972 54569-1114 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate OINTMENT TOPICAL 19840904 NDA NDA019141 A-S Medication Solutions LLC BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-1115_0e6cd631-2865-445e-b40d-7edb2804eca8 54569-1115 HUMAN PRESCRIPTION DRUG BETAMETHASONE VALERATE Betamethasone Valerate CREAM TOPICAL 19880106 ANDA ANDA072041 A-S Medication Solutions LLC BETAMETHASONE VALERATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-1118_bcd3d347-b247-4ef7-9158-de3dd0d73477 54569-1118 HUMAN OTC DRUG hydrocortisone hydrocortisone OINTMENT TOPICAL 20110818 OTC MONOGRAPH NOT FINAL part348 A-S Medication Solutions LLC HYDROCORTISONE 1 g/100g 54569-1121_ca255b2c-f6eb-4c4c-b052-2ebc372c79cf 54569-1121 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 A-S Medication Solutions LLC TRIAMCINOLONE ACETONIDE .25 mg/g 54569-1124_d1fa0d81-1cf3-40f4-ab9b-1ceaa55d977c 54569-1124 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide OINTMENT TOPICAL 19780214 ANDA ANDA085691 A-S Medication Solutions LLC TRIAMCINOLONE ACETONIDE 1 mg/g 54569-1125_3aa0a8ac-1396-45a7-b9d8-850a450a50d7 54569-1125 HUMAN PRESCRIPTION DRUG Nystatin nystatin CREAM TOPICAL 20060531 ANDA ANDA065315 A-S Medication Solutions LLC NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 54569-1139_34f78e15-26da-489c-b213-4f574a709c51 54569-1139 HUMAN PRESCRIPTION DRUG SELENIUM SULFIDE SELENIUM SULFIDE LOTION TOPICAL 20060925 ANDA ANDA089996 A-S Medication Solutions LLC SELENIUM SULFIDE 2.5 mg/100mL 54569-1143_8e00c77f-b71f-46a8-a39e-51b2599d1fd8 54569-1143 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide OINTMENT TOPICAL 19930329 ANDA ANDA063305 A-S Medication Solutions LLC NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 54569-1144_af8c833a-9aaa-42ea-aef3-e4d9deda6d87 54569-1144 HUMAN PRESCRIPTION DRUG Gentamicin sulfate Gentamicin Sulfate OINTMENT TOPICAL 20100317 ANDA ANDA062533 A-S Medication Solutions LLC GENTAMICIN 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 54569-1152_0b496fd8-8fb2-4c5f-a6ff-dc3edbdd8228 54569-1152 HUMAN PRESCRIPTION DRUG Retin-A Tretinoin CREAM TOPICAL 19740730 NDA NDA017522 A-S Medication Solutions LLC TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54569-1154_9084343b-f80a-4e39-a950-ca82d6f14f12 54569-1154 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 19861216 ANDA ANDA089414 A-S Medication Solutions LLC HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-1155_2f3b92dc-a059-4570-b96e-e20391778208 54569-1155 HUMAN PRESCRIPTION DRUG Nystatin nystatin CREAM TOPICAL 20060531 ANDA ANDA065315 A-S Medication Solutions LLC NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 54569-1182_7c8e2001-2647-4fd0-a2e1-3a5d080262b3 54569-1182 HUMAN PRESCRIPTION DRUG TOBREX tobramycin OINTMENT OPHTHALMIC 19810628 NDA NDA050555 A-S Medication Solutions LLC TOBRAMYCIN 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 54569-1186_b0e23007-c8f6-41f7-acb5-a51963c53e00 54569-1186 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfaccetamide Sodium SOLUTION/ DROPS OPHTHALMIC 20040701 ANDA ANDA040066 A-S Medication Solutions LLC SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 54569-1188_dfc13b9e-15f1-40dd-bc59-b1eb48ee5dac 54569-1188 HUMAN PRESCRIPTION DRUG NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN neomycin sulfate, polymyxin b sulfate and gramicidin SOLUTION/ DROPS OPHTHALMIC 19960131 ANDA ANDA064047 A-S Medication Solutions LLC GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE .025; 1.75; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 54569-1193_491723a2-2879-4866-a9b8-cfe1ede3fd43 54569-1193 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19960718 ANDA ANDA064030 A-S Medication Solutions LLC ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54569-1218_debfff94-cadc-446f-b3cd-d780a66a54a7 54569-1218 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 19940511 ANDA ANDA064048 A-S Medication Solutions LLC GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 54569-1224_5f15d3d7-31ba-46b1-8af7-c034d75ecb23 54569-1224 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC 19960726 ANDA ANDA040069 A-S Medication Solutions LLC DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-1229_b44f1692-a3eb-46b7-b13a-f5a6f3341916 54569-1229 HUMAN PRESCRIPTION DRUG Gentak Gentamicin Sulfate OINTMENT OPHTHALMIC 20060508 ANDA ANDA064093 A-S Medication Solutions LLC GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 54569-1231_76b78aae-596a-467c-9717-bfa99ce7bf47 54569-1231 HUMAN OTC DRUG Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20111007 OTC MONOGRAPH FINAL part349 A-S Medication Solutions LLC POLYVINYL ALCOHOL 14 mg/mL 54569-1270_17488f08-2b60-4017-9cc3-6d744f60d4c5 54569-1270 HUMAN PRESCRIPTION DRUG Multi-Vit with Fluoride dl-alpha-tocoheryl acetate and ascorbic acid and cholecalciferol and cyanocobalamin and niacinamide and pyridoxine hydrochloride and riboflavin and fluoride and thiamin hydrochloride and vitamin A palmitate SOLUTION ORAL 19970418 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE 5; 35; 400; 2; 8; .4; .6; .25; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 54569-1280_236dc5ee-b9a0-4fad-bb9f-65b7727a9f7d 54569-1280 HUMAN PRESCRIPTION DRUG Tri-Vit with Fluoride Drops ascorbic acid and cholecalciferol and sodium fluoride and vitamin A palmitate SOLUTION ORAL 19950401 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC ASCORBIC ACID; CHOLECALCIFEROL; SODIUM FLUORIDE; VITAMIN A PALMITATE 35; 400; .25; 1500 mg/mL; [iU]/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 54569-1285_cb50cbc8-b609-4c6b-8f97-d4d39fa42d45 54569-1285 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION OROPHARYNGEAL 20070227 ANDA ANDA040708 A-S Medication Solutions LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 54569-1411_b9693943-5b1a-471f-8eb7-ffe3ce786562 54569-1411 HUMAN PRESCRIPTION DRUG Depo-Testosterone testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 19790725 ANDA ANDA085635 A-S Medication Solutions LLC TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 54569-1444_b0eb3e96-0f3c-4cbb-a8ce-0985efcc16da 54569-1444 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20000316 ANDA ANDA040277 A-S Medication Solutions LLC PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] 54569-1470_87634807-b086-47d4-a74b-79fbc43a6b9f 54569-1470 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072192 A-S Medication Solutions LLC TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 54569-1518_34944625-c156-40bc-b07f-9a6fb2fdd09a 54569-1518 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20120727 ANDA ANDA079175 A-S Medication Solutions LLC INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54569-1519_d7b1e1db-d96d-4b44-9dc6-ca1cd12f51bf 54569-1519 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 A-S Medication Solutions LLC AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 54569-1524_b632c5b4-b63f-4b1b-b9bc-2c2234e58eeb 54569-1524 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA088327 A-S Medication Solutions LLC LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 54569-1544_898851cb-7f52-422e-99dc-432f95d3f2e0 54569-1544 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide CREAM TOPICAL 19821216 ANDA ANDA088170 A-S Medication Solutions LLC FLUOCINOLONE ACETONIDE .1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-1555_ad2fd209-eabf-4c2e-bcdf-3a4f2b9bbcb5 54569-1555 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 A-S Medication Solutions LLC METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-1556_7bc09725-7955-4a55-8737-df4ce0ca385b 54569-1556 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate LOTION TOPICAL 20060630 ANDA ANDA072538 A-S Medication Solutions LLC BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-1585_007344f0-4110-4553-a223-2e6c01c2698a 54569-1585 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 A-S Medication Solutions LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-1640_cca80a77-b982-4edc-b162-eb90341ad011 54569-1640 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride SYRUP ORAL 19950309 ANDA ANDA087294 A-S Medication Solutions LLC HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 54569-1647_05ef31fe-54fd-4003-a97f-92b6328d389b 54569-1647 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20100405 ANDA ANDA089646 A-S Medication Solutions LLC EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 20 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 54569-1657_679e834d-2736-4f6b-8639-973efc5943ee 54569-1657 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19910701 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 54569-1660_81ccfa6f-ede6-403c-b2cc-c1f59acec649 54569-1660 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; RETROBULBAR 20090909 NDA NDA016964 A-S Medication Solutions LLC BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 54569-1696_98fd42e2-0796-410f-bec5-6f12e5c44542 54569-1696 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20121018 ANDA ANDA070791 A-S Medication Solutions LLC DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 54569-1697_f5dcc7cd-f1ab-4ecd-a619-abc45b1f195b 54569-1697 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 19970528 ANDA ANDA040195 A-S Medication Solutions LLC ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 54569-1709_aed3077b-7517-4d32-b5bc-560b8c388412 54569-1709 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 A-S Medication Solutions LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 54569-1712_b95098c6-c6c7-4a0d-966a-976cee6444ba 54569-1712 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20100924 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC SALSALATE 750 mg/1 54569-1718_fbdb4c87-d0f8-48a8-89bd-65f2f3bf5ede 54569-1718 HUMAN PRESCRIPTION DRUG Adipex-P Phentermine Hydrochloride TABLET ORAL 19900930 ANDA ANDA085128 A-S Medication Solutions LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 54569-1726_76743946-b94a-43b4-8d02-4747e4d95b9b 54569-1726 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 A-S Medication Solutions LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-1729_0fbae59e-bc75-4578-855a-bb318fb15807 54569-1729 HUMAN PRESCRIPTION DRUG BECONASE AQ beclomethasone dipropionate monohydrate SPRAY, SUSPENSION NASAL 19891001 NDA NDA019389 A-S Medication Solutions LLC BECLOMETHASONE DIPROPIONATE MONOHYDRATE 42 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-1746_4a312b66-cbee-4f7a-9094-110854bdd890 54569-1746 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 A-S Medication Solutions LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-1754_420bc858-8e0a-4f5a-86ff-9ee8d63963a4 54569-1754 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20120717 ANDA ANDA040712 A-S Medication Solutions LLC PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CIV 54569-1774_828c65aa-73e8-4c2a-a529-457430f4dd36 54569-1774 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 A-S Medication Solutions LLC TRIAMCINOLONE ACETONIDE .25 mg/g 54569-1840_9444cb51-4ea1-4b2d-80d9-deee7fd1fbf7 54569-1840 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19770214 ANDA ANDA062031 A-S Medication Solutions LLC DOXYCYCLINE HYCLATE 100 mg/1 54569-1853_7ce0f8e4-7c0f-4592-825c-eeb2edaa557f 54569-1853 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 A-S Medication Solutions LLC CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54569-1861_312a9923-f30c-40b2-9a4a-1f06cef7efa4 54569-1861 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120112 ANDA ANDA062058 A-S Medication Solutions LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-1873_5cb39f76-5816-402e-8fe4-85ddcbc4ccf3 54569-1873 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate CREAM TOPICAL 19830831 NDA NDA018861 A-S Medication Solutions LLC BETAMETHASONE VALERATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-1874_5cb39f76-5816-402e-8fe4-85ddcbc4ccf3 54569-1874 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate LOTION TOPICAL 19830831 NDA NDA018866 A-S Medication Solutions LLC BETAMETHASONE VALERATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-1889_4b61dfe4-4a46-4d41-8fcb-b0de2c1e5359 54569-1889 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19900930 ANDA ANDA062286 A-S Medication Solutions LLC DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-1899_6202b949-3475-4ac3-9508-c38ba185aca0 54569-1899 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 A-S Medication Solutions LLC POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 54569-1923_23f3b4e8-71a2-47ac-b472-2304c667bf66 54569-1923 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION TOPICAL 20070227 ANDA ANDA040710 A-S Medication Solutions LLC LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 54569-1970_01fc8c74-fa81-492f-aaba-ab25f62267a5 54569-1970 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822 ANDA ANDA089859 A-S Medication Solutions LLC CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 54569-1983_b8b2b072-2095-4a2c-824a-695804bc4ae4 54569-1983 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 19881114 ANDA ANDA071839 A-S Medication Solutions LLC MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 54569-1990_8136d999-b236-4eae-9153-672607d9e3f4 54569-1990 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 19971031 ANDA ANDA075079 A-S Medication Solutions LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54569-1999_87634807-b086-47d4-a74b-79fbc43a6b9f 54569-1999 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072193 A-S Medication Solutions LLC TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 54569-2025_ca255b2c-f6eb-4c4c-b052-2ebc372c79cf 54569-2025 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 A-S Medication Solutions LLC TRIAMCINOLONE ACETONIDE 5 mg/g 54569-2034_c06105ac-b104-495f-b6d2-03affb97c8de 54569-2034 HUMAN OTC DRUG Double Antibiotic Bacitracin Zinc and Polymyxin B Sulfate OINTMENT TOPICAL 20100106 OTC MONOGRAPH FINAL part333B A-S Medication Solutions LLC BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g 54569-2053_9422351a-01f6-4ebc-8526-debee0201c44 54569-2053 HUMAN PRESCRIPTION DRUG Cytomel LIOTHYRONINE SODIUM TABLET ORAL 19560508 NDA NDA010379 A-S Medication Solutions LLC LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 54569-2059_df4f38b3-8dbc-4771-8472-7c61eda1aa63 54569-2059 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Immediate-Release Diethylpropion hydrochloride TABLET ORAL 19590806 NDA NDA011722 A-S Medication Solutions LLC DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 54569-2095_875d94aa-95c3-4df7-932e-344e84c6fa55 54569-2095 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19760702 ANDA ANDA084769 A-S Medication Solutions LLC CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-2113_8868e15d-aaa9-41e8-8605-0f18ee18d98d 54569-2113 HUMAN PRESCRIPTION DRUG ANTIPYRINE AND BENZOCAINE ANTIPYRINE AND BENZOCAINE SOLUTION AURICULAR (OTIC) 20090430 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 54569-2131_105736af-018e-408c-8f67-60adbca232cb 54569-2131 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20110504 ANDA ANDA086030 A-S Medication Solutions LLC TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 54569-2140_3e0ee731-5015-4379-a563-1c2e1809c437 54569-2140 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 A-S Medication Solutions LLC NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 54569-2146_d7b1e1db-d96d-4b44-9dc6-ca1cd12f51bf 54569-2146 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 A-S Medication Solutions LLC AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 54569-2148_d951e91f-71ab-4231-8522-efd87b660382 54569-2148 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 19871222 ANDA ANDA062364 A-S Medication Solutions LLC NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 54569-2154_5a525299-947a-4eec-bf0b-2d0606b8a085 54569-2154 HUMAN OTC DRUG Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20090317 OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC OXYMETAZOLINE HYDROCHLORIDE 5 g/100mL 54569-2163_2893572a-b7fd-449f-9a73-d5caa5e1cb47 54569-2163 HUMAN OTC DRUG MYTAB For GAS Simethicone TABLET, CHEWABLE ORAL 19990312 OTC MONOGRAPH FINAL part332 A-S Medication Solutions LLC DIMETHICONE 80 mg/1 54569-2173_007344f0-4110-4553-a223-2e6c01c2698a 54569-2173 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072928 A-S Medication Solutions LLC LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-2177_6b167efc-5c32-4ece-9e53-b520c0e37dad 54569-2177 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19840626 NDA NDA019117 A-S Medication Solutions LLC FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-2198_b9f3d719-0369-4ae0-9a58-abfb1322cdfe 54569-2198 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate CAPSULE, EXTENDED RELEASE ORAL 19770906 NDA NDA018074 A-S Medication Solutions LLC PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 54569-2199_2dae1992-a9eb-4590-b74c-958e9f33a822 54569-2199 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 A-S Medication Solutions LLC ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54569-2215_05ef31fe-54fd-4003-a97f-92b6328d389b 54569-2215 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20100405 ANDA ANDA089644 A-S Medication Solutions LLC EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 10 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 54569-2222_7ba0ea13-909a-462d-97bc-efc087450111 54569-2222 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC WATER 1 mL/mL 54569-2275_0c92f1c1-3b09-44ad-a457-6ab878533b51 54569-2275 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19840626 NDA NDA019117 A-S Medication Solutions LLC FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-2281_5e52aff0-3a49-4bfb-8a0b-b0c29a318089 54569-2281 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN Erythromycin CAPSULE, DELAYED RELEASE ORAL 20120110 ANDA ANDA062746 A-S Medication Solutions LLC ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54569-2285_711b937a-db77-4333-b1a5-debc27a16021 54569-2285 HUMAN PRESCRIPTION DRUG TobraDex tobramycin and dexamethasone SUSPENSION OPHTHALMIC 19880915 NDA NDA050592 A-S Medication Solutions LLC DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-2295_4638c51e-5d71-4ae5-9233-50adb0e38cea 54569-2295 HUMAN OTC DRUG triple antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20110307 OTC MONOGRAPH FINAL part333B A-S Medication Solutions LLC BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 54569-2299_6d2890cf-8162-4085-9fe6-0e598c5ee539 54569-2299 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20020930 ANDA ANDA089682 A-S Medication Solutions LLC HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-2311_a7a40f17-0363-4b63-8c7f-98ec3a41aa6e 54569-2311 HUMAN PRESCRIPTION DRUG acetic acid acetic acid SOLUTION AURICULAR (OTIC) 20100122 NDA NDA012179 A-S Medication Solutions LLC ACETIC ACID 20.65 mg/mL 54569-2353_e6775ed6-5cdd-4c27-bc8c-64df4334594e 54569-2353 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA087479 A-S Medication Solutions LLC HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 54569-2376_cf836a1d-a69e-4a61-8a56-6f79827c069c 54569-2376 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 19861208 ANDA ANDA077107 A-S Medication Solutions LLC FLURAZEPAM HYDROCHLORIDE 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-2385_bc43f09d-e61a-4cdf-a514-890d61452359 54569-2385 HUMAN OTC DRUG DocQLace docusate sodium CAPSULE ORAL 20110801 OTC MONOGRAPH NOT FINAL part334 A-S Medication Solutions LLC DOCUSATE SODIUM 100 mg/1 54569-2391_33b00a3a-7331-4e3c-b88d-35506bd79260 54569-2391 HUMAN PRESCRIPTION DRUG NEO-POLYCIN NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT OPHTHALMIC 20110715 ANDA ANDA060764 A-S Medication Solutions LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 10000 U/g; mg/g; U/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] 54569-2409_bd27d628-d5a8-44fb-8a47-59f9cb40a082 54569-2409 HUMAN OTC DRUG Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 20100108 OTC MONOGRAPH FINAL part333B A-S Medication Solutions LLC BACITRACIN ZINC 500 [USP'U]/g 54569-2411_5425a7ce-4cba-48dd-92cd-2c52d155546b 54569-2411 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 19880225 ANDA ANDA062882 A-S Medication Solutions LLC AMPICILLIN TRIHYDRATE 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-2433_a696a730-3da7-4586-9b30-4e4f3ea6c27f 54569-2433 HUMAN PRESCRIPTION DRUG Erythromycin Base Erythromycin TABLET, FILM COATED ORAL 20110906 ANDA ANDA061621 A-S Medication Solutions LLC ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54569-2452_ea3733d2-2002-4b71-9646-6128dae8b3ca 54569-2452 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20060512 ANDA ANDA087356 A-S Medication Solutions LLC TRIAMCINOLONE ACETONIDE .25 mg/g 54569-2483_cbda0f5a-2860-4ef2-8a9a-9713f8612f74 54569-2483 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19900930 ANDA ANDA089763 A-S Medication Solutions LLC THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 54569-2502_a696a730-3da7-4586-9b30-4e4f3ea6c27f 54569-2502 HUMAN PRESCRIPTION DRUG Erythromycin Base Erythromycin TABLET, FILM COATED ORAL 20110906 ANDA ANDA061621 A-S Medication Solutions LLC ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54569-2507_cf56ce90-c1b9-4e30-bb5e-7031e9adf47b 54569-2507 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN ETHYLSUCCINATE Erythromycin Ethylsuccinate TABLET ORAL 20111003 ANDA ANDA061904 A-S Medication Solutions LLC ERYTHROMYCIN ETHYLSUCCINATE 400 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54569-2508_2dae1992-a9eb-4590-b74c-958e9f33a822 54569-2508 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 A-S Medication Solutions LLC ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54569-2509_5eab2d40-eedb-4b8b-a0c9-d757845c1af8 54569-2509 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080937 A-S Medication Solutions LLC ISONIAZID 300 mg/1 Antimycobacterial [EPC] 54569-2523_3c525ad3-8ccb-4310-b385-79bed00a62ba 54569-2523 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 54569-2538_7000b295-7980-4196-acdd-b7656ac9e3d2 54569-2538 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030827 ANDA ANDA040511 A-S Medication Solutions LLC ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 54569-2545_4c215882-ae94-4a2d-9ec1-7b9e8a6f0785 54569-2545 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20090921 ANDA ANDA071251 A-S Medication Solutions LLC HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54569-2556_65821270-1506-4867-8511-0a6fb0e7e691 54569-2556 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 19840626 NDA NDA019137 A-S Medication Solutions LLC BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-2571_e6775ed6-5cdd-4c27-bc8c-64df4334594e 54569-2571 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA086183 A-S Medication Solutions LLC HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 54569-2586_a31b5d08-e78b-4965-8a70-d2e5f303dfd7 54569-2586 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 19900701 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-2590_b033a6b4-95a1-4338-8f63-7bc4c6d7a443 54569-2590 HUMAN PRESCRIPTION DRUG TobraDex tobramycin and dexamethasone OINTMENT OPHTHALMIC 19881015 NDA NDA050616 A-S Medication Solutions LLC DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-2594_6e3c0223-0080-425a-ae04-d8d6ee6dedcf 54569-2594 HUMAN OTC DRUG Eye Irrigating Purified Water SOLUTION OPHTHALMIC 20111007 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC WATER 99.05 mL/100mL 54569-2619_67e46388-7259-43f8-9485-b7401b933e16 54569-2619 HUMAN PRESCRIPTION DRUG ELOCON Mometasone Furoate CREAM TOPICAL 19870506 NDA NDA019625 A-S Medication Solutions LLC MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 54569-2655_b14966f1-24d0-4785-a481-01efaf8c2c29 54569-2655 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 A-S Medication Solutions LLC CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 54569-2657_5b66594f-d7a1-4943-92e4-1e50361175c4 54569-2657 HUMAN PRESCRIPTION DRUG Naphazoline Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19951219 ANDA ANDA083590 A-S Medication Solutions LLC NAPHAZOLINE HYDROCHLORIDE 1 mg/mL 54569-2668_6eba64f0-2586-4222-aa26-bb39be739d20 54569-2668 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 A-S Medication Solutions LLC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 54569-2687_007344f0-4110-4553-a223-2e6c01c2698a 54569-2687 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072926 A-S Medication Solutions LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-2702_696eeae8-2240-46b9-a0ea-3ead346494ca 54569-2702 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 A-S Medication Solutions LLC PENICILLIN V POTASSIUM 250 mg/1 54569-2710_ceddb186-5e47-4e4f-b173-c58be7fb4030 54569-2710 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 A-S Medication Solutions LLC PENICILLIN V POTASSIUM 500 mg/1 54569-2765_2adcb8f1-abbc-45c2-9fa0-4ee552e4c560 54569-2765 HUMAN PRESCRIPTION DRUG Cytotec misoprostol TABLET ORAL 19861227 NDA NDA019268 A-S Medication Solutions LLC MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 54569-2784_2d8ad8ad-3d20-4ba1-9dab-e2f300543972 54569-2784 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate SOLUTION OPHTHALMIC 19900930 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC ATROPINE SULFATE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54569-2801_f34ff3dd-ab83-4d04-b0bc-1d9deab95401 54569-2801 HUMAN PRESCRIPTION DRUG clonidine hydrochloride Clonidine Hydrochloride TABLET ORAL 20130204 ANDA ANDA091368 A-S Medication Solutions LLC CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54569-2861_8b27a5a9-e2d7-40f4-93ee-d5fb08faef4d 54569-2861 HUMAN PRESCRIPTION DRUG SUPRAX cefixime TABLET ORAL 20080401 ANDA ANDA065130 A-S Medication Solutions LLC CEFIXIME 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54569-2864_db738906-04aa-48f9-aa21-79d3466e9f3b 54569-2864 HUMAN OTC DRUG Dimenhydrinate Dimenhydrinate TABLET ORAL 20040301 OTC MONOGRAPH FINAL part336 A-S Medication Solutions LLC DIMENHYDRINATE 50 mg/1 54569-2867_f17e6806-1774-4a23-81cf-45e6d6d76346 54569-2867 HUMAN PRESCRIPTION DRUG Polytrim polymyxin b sulfate and trimethoprim sulfate SOLUTION/ DROPS OPHTHALMIC 19900123 NDA NDA050567 A-S Medication Solutions LLC POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 100000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 54569-2868_9ae06f62-3989-4387-bcc9-d337c6d38882 54569-2868 HUMAN PRESCRIPTION DRUG PRED FORTE prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19730601 NDA NDA017011 A-S Medication Solutions LLC PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-2900_5d7676a3-bc57-426d-a25b-50669d74cb97 54569-2900 HUMAN PRESCRIPTION DRUG Isoniazid isoniazid SOLUTION ORAL 19831111 ANDA ANDA088235 A-S Medication Solutions LLC ISONIAZID 50 mg/5mL Antimycobacterial [EPC] 54569-2918_8e7cb87c-79c5-46d0-88b7-5ccb6b66dd87 54569-2918 HUMAN OTC DRUG Novolin 70/30 Human Insulin INJECTION, SUSPENSION SUBCUTANEOUS 19910625 NDA NDA019991 A-S Medication Solutions LLC INSULIN HUMAN 100 [USP'U]/mL 54569-2928_ada15ddb-c5d6-40fc-a06e-c142d5c7dc64 54569-2928 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 A-S Medication Solutions LLC AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-2929_edbfbad4-8b9e-46fa-b491-b506c7254b5f 54569-2929 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 A-S Medication Solutions LLC AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-2930_4e02dc5d-36c0-48a7-9d0f-6f6ff58cb8f2 54569-2930 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20070326 ANDA ANDA065387 A-S Medication Solutions LLC AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-2931_a474c1d3-ed38-41f7-b5ef-f1ade316f006 54569-2931 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 A-S Medication Solutions LLC AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-2933_166ab686-97b8-4508-9c9a-b788ca7616b4 54569-2933 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 19900930 ANDA ANDA060456 A-S Medication Solutions LLC PENICILLIN V POTASSIUM 250 mg/5mL 54569-2935_189950fe-e593-48ca-bfac-bf4f4ffccdf4 54569-2935 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 19900930 ANDA ANDA060456 A-S Medication Solutions LLC PENICILLIN V POTASSIUM 250 mg/5mL 54569-2942_5eab2d40-eedb-4b8b-a0c9-d757845c1af8 54569-2942 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080936 A-S Medication Solutions LLC ISONIAZID 100 mg/1 Antimycobacterial [EPC] 54569-2954_280902d9-cd3d-4b85-a80d-972d1c6b3dfa 54569-2954 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 A-S Medication Solutions LLC AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-2968_9422351a-01f6-4ebc-8526-debee0201c44 54569-2968 HUMAN PRESCRIPTION DRUG Cytomel LIOTHYRONINE SODIUM TABLET ORAL 19560508 NDA NDA010379 A-S Medication Solutions LLC LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 54569-2996_2a1d432b-5efb-4292-aa0c-f4d689078a02 54569-2996 HUMAN OTC DRUG Hibiclens Chlorhexidine gluconate SOLUTION TOPICAL 19760917 NDA NDA017768 A-S Medication Solutions LLC CHLORHEXIDINE GLUCONATE 213 g/1000mL 54569-3040_766c5a3e-3e0e-4beb-969e-c109a954e984 54569-3040 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000907 ANDA ANDA084916 A-S Medication Solutions LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-3043_0f00f49e-0ece-4771-92fd-23b776dc1d86 54569-3043 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19740226 ANDA ANDA083677 A-S Medication Solutions LLC PREDNISONE 20 mg/1 54569-3069_0c98e4c6-5a04-4659-bec3-d2925a48cdb0 54569-3069 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040875 A-S Medication Solutions LLC PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 54569-3070_7e5edcf6-c8e2-4fd9-9f6c-534e52341b00 54569-3070 HUMAN PRESCRIPTION DRUG Myambutol Ethambutol hydrochloride TABLET, FILM COATED ORAL 20070810 NDA NDA016320 A-S Medication Solutions LLC ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] 54569-3074_63b49d29-638b-4c0c-9066-f8b8b6e155cb 54569-3074 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 19830202 ANDA ANDA062421 A-S Medication Solutions LLC DOXYCYCLINE HYCLATE 100 mg/1 54569-3121_b672aab0-d7be-4213-9214-107638162c63 54569-3121 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE, LIQUID FILLED ORAL 19910101 ANDA ANDA072579 A-S Medication Solutions LLC NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54569-3146_ec13b5cb-c30f-4a40-b095-fae58eb90fb1 54569-3146 HUMAN OTC DRUG Cheratussin AC codeine phosphate and guaifenesin LIQUID ORAL 19960901 OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 54569-3176_1dbe4af8-a988-44c9-9b06-cef59281f8f2 54569-3176 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20100315 ANDA ANDA040865 A-S Medication Solutions LLC ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 54569-3177_953ec994-3268-4e6c-a75a-abb3137125d8 54569-3177 HUMAN OTC DRUG Q Tussin DM Dextromethorphan HBr and Guaifenesin SYRUP ORAL 19950401 OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 54569-3195_8a850bff-faac-4938-8c90-af6692b5b225 54569-3195 HUMAN PRESCRIPTION DRUG Terazol 3 TERCONAZOLE CREAM VAGINAL 19910221 NDA NDA019964 A-S Medication Solutions LLC TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 54569-3203_90e7fdd5-4214-4dc0-a941-3b42bae541bc 54569-3203 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120815 ANDA ANDA040876 A-S Medication Solutions LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 54569-3259_dc3f4093-c45d-4edc-9249-e87fee7af6ec 54569-3259 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19960828 ANDA ANDA064065 A-S Medication Solutions LLC HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 54569-3265_bc1bf9e6-053c-43b3-aa6b-19f89f417d5d 54569-3265 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 A-S Medication Solutions LLC DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 54569-3285_a9c3bd97-aa7a-4af1-91bd-9fee3bbc2b99 54569-3285 HUMAN OTC DRUG Pepto-Bismol Bismuth subsalicylate LIQUID ORAL 19890331 OTC MONOGRAPH FINAL part335 A-S Medication Solutions LLC BISMUTH SUBSALICYLATE 525 mg/30mL 54569-3302_fc90f160-ea14-4466-8023-b3c232ab4f9e 54569-3302 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA084122 A-S Medication Solutions LLC PREDNISONE 10 mg/1 54569-3324_d4e31041-75ae-4969-998d-b6864a952614 54569-3324 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110120 ANDA ANDA090836 A-S Medication Solutions LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54569-3332_df5bbd61-5f99-47b9-b83b-e227ed5b9f48 54569-3332 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 A-S Medication Solutions LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54569-3335_e08699c1-3712-46ab-bc01-9d391eb37c4b 54569-3335 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120112 ANDA ANDA062058 A-S Medication Solutions LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-3341_1e1856e5-811e-4185-bd2d-d82ab7f07be2 54569-3341 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 A-S Medication Solutions LLC HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-3354_31148775-8392-4cad-a736-546dc45e7c42 54569-3354 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110822 ANDA ANDA070044 A-S Medication Solutions LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 54569-3372_635c3d5b-c8ce-4f1d-a97b-b9cc203850b6 54569-3372 HUMAN PRESCRIPTION DRUG Multi Vitamin with Fluoride Multi Vitamin with Fluoride TABLET, CHEWABLE ORAL 20091009 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A ACETATE 15; 24; 400; 4.5; .3; 13.5; 1.05; 1.2; 36; .5; 1.05; 2500 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 54569-3394_7de681d5-b4f4-40a5-802a-4f08d36e1f60 54569-3394 HUMAN PRESCRIPTION DRUG Nizoral ketoconazole SHAMPOO TOPICAL 19900831 NDA NDA019927 A-S Medication Solutions LLC KETOCONAZOLE 20 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 54569-3398_4df4898e-c86e-4fa5-88b2-b8530301ec06 54569-3398 HUMAN OTC DRUG triple antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20110307 OTC MONOGRAPH FINAL part333B A-S Medication Solutions LLC BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 54569-3403_0173aeef-5ee4-4ac8-ab97-ee8a085e20a5 54569-3403 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 A-S Medication Solutions LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 54569-3405_92779a56-0b70-4d34-9853-d4be2ccc994d 54569-3405 HUMAN OTC DRUG Acne Medication 10 Benzoyl Peroxide GEL TOPICAL 20121029 OTC MONOGRAPH FINAL part333D A-S Medication Solutions LLC BENZOYL PEROXIDE 100 mg/g 54569-3406_82352374-88dd-4531-b51f-a41769eac665 54569-3406 HUMAN OTC DRUG Acne Medication 5 Benzoyl Peroxide GEL TOPICAL 20121029 OTC MONOGRAPH FINAL part333D A-S Medication Solutions LLC BENZOYL PEROXIDE 50 mg/g 54569-3413_34487f13-b1d5-4c72-a92d-68c3e8370bef 54569-3413 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 A-S Medication Solutions LLC PREDNISONE 5 mg/1 54569-3439_6f157348-07b1-435d-936e-18aeaf516b17 54569-3439 HUMAN PRESCRIPTION DRUG Biaxin Clarithromycin TABLET, FILM COATED ORAL 19911031 NDA NDA050662 A-S Medication Solutions LLC CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 54569-3456_cbe5569e-2563-4706-8b6b-4f3a9df99831 54569-3456 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090826 ANDA ANDA065442 A-S Medication Solutions LLC CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 54569-3473_76750aa6-39d0-4981-ac05-c1d0ce8c8ff3 54569-3473 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE TOPICAL 20100707 ANDA ANDA040771 A-S Medication Solutions LLC TRIAMCINOLONE ACETONIDE 1 mg/g 54569-3504_35ab0b00-751f-4a65-ba44-663041baf1d9 54569-3504 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 54569-3563_2dae1992-a9eb-4590-b74c-958e9f33a822 54569-3563 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 A-S Medication Solutions LLC ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54569-3570_8eabc230-741d-4a7e-b115-a9a44d99558f 54569-3570 HUMAN PRESCRIPTION DRUG AK-POLY-BAC Bacitracin Zinc and Polymyxin B Sulfate OINTMENT OPHTHALMIC 20060508 ANDA ANDA064028 A-S Medication Solutions LLC BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 54569-3658_0cda98e1-3749-480d-8705-872b8be79a50 54569-3658 HUMAN PRESCRIPTION DRUG Diflunisal Diflunisal TABLET, FILM COATED ORAL 19921101 ANDA ANDA073673 A-S Medication Solutions LLC DIFLUNISAL 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54569-3667_4f97a4e0-9e5c-42bd-87cc-ea9cfd77a200 54569-3667 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 A-S Medication Solutions LLC DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54569-3688_fb6e7359-23f8-4673-b66e-d428f067c7dc 54569-3688 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101 ANDA ANDA073517 A-S Medication Solutions LLC KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54569-3689_edbfbad4-8b9e-46fa-b491-b506c7254b5f 54569-3689 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, CHEWABLE ORAL 19930101 ANDA ANDA064013 A-S Medication Solutions LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-3693_8625d9b4-26fe-4880-be22-2dd40f4e28a7 54569-3693 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20100105 ANDA ANDA074118 A-S Medication Solutions LLC PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54569-3695_c72571ee-15d7-4606-886b-a6811e1ebec9 54569-3695 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20110101 ANDA ANDA077836 A-S Medication Solutions LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 54569-3701_d960db5c-1a70-4bca-a5d1-ee01813f2e18 54569-3701 HUMAN PRESCRIPTION DRUG Depo-Provera medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19921029 NDA NDA020246 A-S Medication Solutions LLC MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54569-3707_0686b63f-0188-40e5-b7b0-476c138eaf9c 54569-3707 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA073192 A-S Medication Solutions LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 54569-3755_2c481e99-95e0-45dd-bf46-f7825c0637f4 54569-3755 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20080925 ANDA ANDA078491 A-S Medication Solutions LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-3756_2c481e99-95e0-45dd-bf46-f7825c0637f4 54569-3756 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20080925 ANDA ANDA078491 A-S Medication Solutions LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-3807_b078dacc-3369-43d3-b263-415b1a136281 54569-3807 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961203 ANDA ANDA040159 A-S Medication Solutions LLC MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54569-3820_df5bbd61-5f99-47b9-b83b-e227ed5b9f48 54569-3820 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 A-S Medication Solutions LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54569-3827_ed68c40d-ba70-4919-9a7d-812090e5a1cf 54569-3827 HUMAN PRESCRIPTION DRUG Ambien zolpidem tartrate TABLET, FILM COATED ORAL 19930401 NDA NDA019908 A-S Medication Solutions LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 54569-3828_ed68c40d-ba70-4919-9a7d-812090e5a1cf 54569-3828 HUMAN PRESCRIPTION DRUG Ambien zolpidem tartrate TABLET, FILM COATED ORAL 19930401 NDA NDA019908 A-S Medication Solutions LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 54569-3887_f0607739-5b18-48f9-a7f4-af7ef2485b84 54569-3887 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19840626 NDA NDA019117 A-S Medication Solutions LLC FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-3899_b4f79d6d-6721-4079-b48d-88f55a1219da 54569-3899 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION INTRABRONCHIAL 20101104 ANDA ANDA077839 A-S Medication Solutions LLC ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 54569-3901_7ac8ec2a-4159-485f-a61e-e7988a2e522e 54569-3901 HUMAN PRESCRIPTION DRUG CEFACLOR CEFACLOR CAPSULE ORAL 20070501 ANDA ANDA065350 A-S Medication Solutions LLC CEFACLOR 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54569-3902_7ac8ec2a-4159-485f-a61e-e7988a2e522e 54569-3902 HUMAN PRESCRIPTION DRUG CEFACLOR CEFACLOR CAPSULE ORAL 20070501 ANDA ANDA065350 A-S Medication Solutions LLC CEFACLOR 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54569-3912_7f29ad1b-ea80-4485-bbac-f7101aee0705 54569-3912 HUMAN PRESCRIPTION DRUG Brevital Sodium methohexital sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; RECTAL 20071101 NDA NDA011559 A-S Medication Solutions LLC METHOHEXITAL SODIUM 500 mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] CIV 54569-3966_00b6b1de-85df-4e29-852a-905852ffc9ac 54569-3966 HUMAN PRESCRIPTION DRUG Triazolam triazolam TABLET ORAL 19821115 NDA AUTHORIZED GENERIC NDA017892 A-S Medication Solutions LLC TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-4002_df5bbd61-5f99-47b9-b83b-e227ed5b9f48 54569-4002 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 A-S Medication Solutions LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54569-4026_fc90f160-ea14-4466-8023-b3c232ab4f9e 54569-4026 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 A-S Medication Solutions LLC PREDNISONE 5 mg/1 54569-4048_680d90a9-70ea-4bdd-932c-bf699cba96cf 54569-4048 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 A-S Medication Solutions LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 54569-4089_a04950a6-a80c-4875-9098-1bfcf1ab0939 54569-4089 HUMAN PRESCRIPTION DRUG ULTRAM tramadol hydrochloride TABLET, COATED ORAL 19950303 NDA NDA020281 A-S Medication Solutions LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 54569-4143_0c98e4c6-5a04-4659-bec3-d2925a48cdb0 54569-4143 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 A-S Medication Solutions LLC PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 54569-4168_f94ba15b-24b3-44bf-8695-fc52b703824a 54569-4168 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20120717 ANDA ANDA040712 A-S Medication Solutions LLC PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CIV 54569-4197_77279f2b-ac6f-4908-9327-f74bd2fd2a6d 54569-4197 HUMAN OTC DRUG Qdryl Allergy Diphenhydramine Hydrochloride SOLUTION ORAL 19971201 OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 54569-4210_6b167efc-5c32-4ece-9e53-b520c0e37dad 54569-4210 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide OINTMENT TOPICAL 19990630 ANDA ANDA075008 A-S Medication Solutions LLC FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-4325_afd5ec91-5195-4e9e-af9c-e0434e137728 54569-4325 HUMAN PRESCRIPTION DRUG AUGMENTIN amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19961002 NDA NDA050720 A-S Medication Solutions LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; 1/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54569-4336_480e7f7a-4008-419e-9acc-c34854bedd1a 54569-4336 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 A-S Medication Solutions LLC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 54569-4387_5b7486cb-62a0-480c-8f01-f9753bc2d7e0 54569-4387 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 19970528 ANDA ANDA040195 A-S Medication Solutions LLC ACETAZOLAMIDE 125 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 54569-4391_f27db70d-b07d-488f-805e-63d97ca2f294 54569-4391 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20080423 ANDA ANDA065392 A-S Medication Solutions LLC CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54569-4400_ccf4d014-f102-4ed2-8c88-d1d5162873c1 54569-4400 HUMAN PRESCRIPTION DRUG TobraDex tobramycin and dexamethasone SUSPENSION OPHTHALMIC 19880915 NDA NDA050592 A-S Medication Solutions LLC DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-4443_dfb61538-1af9-4bd5-a407-ae696d88f7ac 54569-4443 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 A-S Medication Solutions LLC WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54569-4466_95658014-d74c-41d4-815a-029f91ec6b2e 54569-4466 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19970311 NDA NDA020702 A-S Medication Solutions LLC ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54569-4467_95658014-d74c-41d4-815a-029f91ec6b2e 54569-4467 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19970311 NDA NDA020702 A-S Medication Solutions LLC ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54569-4471_62ea9122-3580-43b2-89e2-5b64e9cc627e 54569-4471 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC THYROID, PORCINE 90 mg/1 54569-4586_5e2b23b4-3dc1-490f-8a3c-9ab7ee82c8a4 54569-4586 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20000427 ANDA ANDA075731 A-S Medication Solutions LLC CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-4587_95658014-d74c-41d4-815a-029f91ec6b2e 54569-4587 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19980608 NDA NDA020702 A-S Medication Solutions LLC ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54569-4605_29277dbb-5cd8-4e31-b99a-977a6fca2ee6 54569-4605 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, FILM COATED ORAL 19980812 NDA NDA020829 A-S Medication Solutions LLC MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 54569-4614_680d90a9-70ea-4bdd-932c-bf699cba96cf 54569-4614 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 A-S Medication Solutions LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 54569-4619_2c481e99-95e0-45dd-bf46-f7825c0637f4 54569-4619 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20080925 ANDA ANDA078491 A-S Medication Solutions LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-4648_bec00cd7-b10a-441e-bf43-cd9447ae2c51 54569-4648 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000907 ANDA ANDA084916 A-S Medication Solutions LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-4671_b1fca7bd-79f2-432e-aafe-0a54bc83dec8 54569-4671 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19990125 NDA NDA020998 A-S Medication Solutions LLC CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54569-4672_b1fca7bd-79f2-432e-aafe-0a54bc83dec8 54569-4672 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19990125 NDA NDA020998 A-S Medication Solutions LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54569-4700_230de062-4386-4ae4-b6d5-da1035f17df1 54569-4700 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 19990226 NDA NDA020839 A-S Medication Solutions LLC CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 54569-4728_b41e2831-bc64-47bc-bb33-ddc8e2e77339 54569-4728 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 A-S Medication Solutions LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-4736_29277dbb-5cd8-4e31-b99a-977a6fca2ee6 54569-4736 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 20001110 NDA NDA020830 A-S Medication Solutions LLC MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 54569-4737_318b3c4f-be36-4ca1-bd85-acaa33565455 54569-4737 HUMAN PRESCRIPTION DRUG CEFTIN cefuroxime axetil POWDER, FOR SUSPENSION ORAL 20040602 NDA NDA050672 A-S Medication Solutions LLC CEFUROXIME AXETIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54569-4742_ef98c8b4-41d2-4bbe-b1c2-ae36e89e699e 54569-4742 HUMAN PRESCRIPTION DRUG Xenical orlistat CAPSULE ORAL 20101217 NDA NDA020766 A-S Medication Solutions LLC ORLISTAT 120 mg/1 Intestinal Lipase Inhibitor [EPC],Lipase Inhibitors [MoA] 54569-4768_5d26352b-5e73-4bb6-bc47-4c0999f12cbc 54569-4768 HUMAN PRESCRIPTION DRUG Flomax tamsulosin hydrochloride CAPSULE ORAL 19990603 NDA NDA020579 A-S Medication Solutions LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 54569-4781_828c65aa-73e8-4c2a-a529-457430f4dd36 54569-4781 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 A-S Medication Solutions LLC TRIAMCINOLONE ACETONIDE 1 mg/g 54569-4816_90e7fdd5-4214-4dc0-a941-3b42bae541bc 54569-4816 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120815 ANDA ANDA040887 A-S Medication Solutions LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 54569-4900_6ada4251-188d-4fe6-9e78-7d330418c5ab 54569-4900 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20101015 ANDA ANDA090248 A-S Medication Solutions LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-4904_d960db5c-1a70-4bca-a5d1-ee01813f2e18 54569-4904 HUMAN PRESCRIPTION DRUG Depo-Provera medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19921029 NDA NDA020246 A-S Medication Solutions LLC MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54569-4953_6f157348-07b1-435d-936e-18aeaf516b17 54569-4953 HUMAN PRESCRIPTION DRUG Biaxin Clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000303 NDA NDA050775 A-S Medication Solutions LLC CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 54569-5116_f90a7fbe-800b-4f62-ba0d-565e46db4f48 54569-5116 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075293 A-S Medication Solutions LLC MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-5126_b6616836-17a3-4ef9-b3f9-e805d4d25e48 54569-5126 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 A-S Medication Solutions LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-5167_29277dbb-5cd8-4e31-b99a-977a6fca2ee6 54569-5167 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 19990423 NDA NDA020830 A-S Medication Solutions LLC MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 54569-5182_4e02dc5d-36c0-48a7-9d0f-6f6ff58cb8f2 54569-5182 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20050713 ANDA ANDA065228 A-S Medication Solutions LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-5193_41c8d503-82bb-4504-975a-dc7379310c71 54569-5193 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 A-S Medication Solutions LLC AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-5195_480e7f7a-4008-419e-9acc-c34854bedd1a 54569-5195 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 A-S Medication Solutions LLC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 54569-5224_dd597813-b1ef-4216-9bbc-b850cfd5acea 54569-5224 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120815 ANDA ANDA040876 A-S Medication Solutions LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 54569-5227_b6616836-17a3-4ef9-b3f9-e805d4d25e48 54569-5227 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 A-S Medication Solutions LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-5233_6eba64f0-2586-4222-aa26-bb39be739d20 54569-5233 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 A-S Medication Solutions LLC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 54569-5240_2df6f9fc-5e0c-4c13-a319-350093eaf576 54569-5240 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 A-S Medication Solutions LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 54569-5255_f90a7fbe-800b-4f62-ba0d-565e46db4f48 54569-5255 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075293 A-S Medication Solutions LLC MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-5273_081d3a77-a34f-4dc8-b032-6e25ec6cacd1 54569-5273 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010628 NDA NDA021153 A-S Medication Solutions LLC ESOMEPRAZOLE MAGNESIUM 20 mg/1 54569-5274_081d3a77-a34f-4dc8-b032-6e25ec6cacd1 54569-5274 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010628 NDA NDA021153 A-S Medication Solutions LLC ESOMEPRAZOLE MAGNESIUM 40 mg/1 54569-5301_97030f45-a354-4d25-adda-d8c0b8b5f044 54569-5301 HUMAN PRESCRIPTION DRUG Depo-Testosterone testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 19790725 ANDA ANDA085635 A-S Medication Solutions LLC TESTOSTERONE CYPIONATE 100 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 54569-5308_b393eeb7-f0c4-43e9-9d97-ca0dface9182 54569-5308 HUMAN PRESCRIPTION DRUG ULTRACET tramadol hydrochloride and acetaminophen TABLET, COATED ORAL 20010815 NDA NDA021123 A-S Medication Solutions LLC ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 54569-5339_5cd78d23-972b-4315-81f4-cd92eb5ba018 54569-5339 HUMAN PRESCRIPTION DRUG Androgel Testosterone GEL TRANSDERMAL 20110314 NDA NDA021015 A-S Medication Solutions LLC TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 54569-5353_78db3b0c-fec8-4c51-86f5-5ac38501f455 54569-5353 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 A-S Medication Solutions LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 54569-5354_23c27189-0dc2-4b9e-a23a-4fd20448cdd2 54569-5354 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 A-S Medication Solutions LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-5360_78db3b0c-fec8-4c51-86f5-5ac38501f455 54569-5360 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 A-S Medication Solutions LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 54569-5373_78db3b0c-fec8-4c51-86f5-5ac38501f455 54569-5373 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 A-S Medication Solutions LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 54569-5382_95658014-d74c-41d4-815a-029f91ec6b2e 54569-5382 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20020408 NDA NDA020702 A-S Medication Solutions LLC ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54569-5386_5990533c-1cf1-40d9-9196-cebc33fea8b7 54569-5386 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 A-S Medication Solutions LLC CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54569-5401_307d6c8f-791e-441f-9684-76a5fbfb793a 54569-5401 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 A-S Medication Solutions LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-5418_61e9cd92-819c-42aa-99b5-85629dc58542 54569-5418 HUMAN PRESCRIPTION DRUG Cefuroxime axetil Cefuroxime axetil TABLET, FILM COATED ORAL 20101201 ANDA ANDA065496 A-S Medication Solutions LLC CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54569-5436_4d9a299f-6484-4ab0-819c-766cfe542102 54569-5436 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 A-S Medication Solutions LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 54569-5470_615b7651-9fc6-4715-ac65-4941d8475769 54569-5470 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091569 A-S Medication Solutions LLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54569-5471_615b7651-9fc6-4715-ac65-4941d8475769 54569-5471 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091568 A-S Medication Solutions LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54569-5487_d6b3f1a0-c188-4f59-9186-9765150373bb 54569-5487 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 A-S Medication Solutions LLC AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54569-5488_d6b3f1a0-c188-4f59-9186-9765150373bb 54569-5488 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 A-S Medication Solutions LLC AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54569-5489_a1796b03-b6a5-4a25-950b-cede4d002197 54569-5489 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20090727 NDA NDA021445 A-S Medication Solutions LLC EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] 54569-5503_b6616836-17a3-4ef9-b3f9-e805d4d25e48 54569-5503 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 A-S Medication Solutions LLC CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-5523_25583150-769c-4775-8496-0787bd4620d7 54569-5523 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 A-S Medication Solutions LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 54569-5532_5cb1d2e0-d759-4ba9-bb99-b4267adc071b 54569-5532 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR SULFATE CAPSULE, GELATIN COATED ORAL 20030624 NDA NDA021567 A-S Medication Solutions LLC ATAZANAVIR SULFATE 200 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 54569-5553_5b222f1a-5a60-460e-a3dd-924ef07c3585 54569-5553 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20030226 ANDA ANDA065119 A-S Medication Solutions LLC AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-5574_40858305-7dd8-44f1-b564-8e54a6f49649 54569-5574 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 A-S Medication Solutions LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54569-5584_40858305-7dd8-44f1-b564-8e54a6f49649 54569-5584 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 A-S Medication Solutions LLC CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54569-5595_ffdcd70b-6de2-4b87-a1ad-f685297975bb 54569-5595 HUMAN PRESCRIPTION DRUG Testim testosterone GEL TRANSDERMAL 20021031 NDA NDA021454 A-S Medication Solutions LLC TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 54569-5600_77a9257b-0826-4283-84d9-f88ad9125474 54569-5600 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20040902 NDA NDA021366 A-S Medication Solutions LLC ROSUVASTATIN CALCIUM 10 mg/1 54569-5616_bef63518-6728-40f1-95d6-0f4586887a34 54569-5616 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19921029 NDA AUTHORIZED GENERIC NDA020246 A-S Medication Solutions LLC MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54569-5638_184b7d98-815c-4aa7-83a3-d5f28104c734 54569-5638 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, CHEWABLE ORAL 20050210 ANDA ANDA065205 A-S Medication Solutions LLC AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54569-5672_77a9257b-0826-4283-84d9-f88ad9125474 54569-5672 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20050414 NDA NDA021366 A-S Medication Solutions LLC ROSUVASTATIN CALCIUM 20 mg/1 54569-5680_15c76827-32b9-4c5d-99cf-4cec21f5ccda 54569-5680 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 A-S Medication Solutions LLC ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 54569-5684_f3327069-f904-418f-9a42-7ee8dc10209d 54569-5684 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 A-S Medication Solutions LLC ESZOPICLONE 3 mg/1 CIV 54569-5689_a38095b7-9210-4f38-b5e5-6e4eeed7c7e3 54569-5689 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050575 A-S Medication Solutions LLC AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54569-5690_7b89e1ee-11a9-4754-a392-847e7d2ddfeb 54569-5690 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20071201 ANDA ANDA065191 A-S Medication Solutions LLC AMOXICILLIN; CLAVULANIC ACID 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54569-5696_f3327069-f904-418f-9a42-7ee8dc10209d 54569-5696 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 A-S Medication Solutions LLC ESZOPICLONE 2 mg/1 CIV 54569-5727_3fa443fd-017a-43ee-b9b0-96deed23e825 54569-5727 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120112 ANDA ANDA062058 A-S Medication Solutions LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-5729_df5d6099-eee3-4eeb-9176-e76e3eb87425 54569-5729 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 A-S Medication Solutions LLC DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54569-5736_9df20a4a-bf75-4fba-9118-b06f679e23f6 54569-5736 HUMAN PRESCRIPTION DRUG Promethazine VC Promethazinehydrochloride and phenylephrine hydrochloride SYRUP ORAL 20061207 ANDA ANDA040654 A-S Medication Solutions LLC PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 5; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 54569-5746_77a9257b-0826-4283-84d9-f88ad9125474 54569-5746 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20051026 NDA NDA021366 A-S Medication Solutions LLC ROSUVASTATIN CALCIUM 5 mg/1 54569-5750_41243d21-6839-4821-8ed0-ec7e5d88e944 54569-5750 HUMAN PRESCRIPTION DRUG TRICOR fenofibrate TABLET ORAL 20051107 NDA NDA021656 A-S Medication Solutions LLC FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 54569-5758_bc1bf9e6-053c-43b3-aa6b-19f89f417d5d 54569-5758 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 A-S Medication Solutions LLC DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 54569-5759_76066d10-dded-41cd-a395-dcfb68975896 54569-5759 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20100212 ANDA ANDA201451 A-S Medication Solutions LLC MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 54569-5760_855d8ecb-78d9-48c5-82f9-7f6e995b3484 54569-5760 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20050919 NDA NDA021774 A-S Medication Solutions LLC ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 54569-5785_2c67d656-e294-45a5-b906-0886e1bd8f87 54569-5785 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL POWDER, FOR SUSPENSION ORAL 20051201 ANDA ANDA065261 A-S Medication Solutions LLC CEFPROZIL 250 mg/5mL 54569-5813_01714fb6-6ac6-4f07-8985-ce1f91306ea5 54569-5813 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20070125 ANDA ANDA078060 A-S Medication Solutions LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 54569-5825_d22808bc-28ea-46d4-ad57-70bdea4e5bfb 54569-5825 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 A-S Medication Solutions LLC PREGABALIN 75 mg/1 CV 54569-5831_5164db94-101c-47a0-b55a-5886c0457d96 54569-5831 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201091 A-S Medication Solutions LLC AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54569-5840_34487f13-b1d5-4c72-a92d-68c3e8370bef 54569-5840 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 A-S Medication Solutions LLC PREDNISONE 10 mg/1 54569-5864_5cb1d2e0-d759-4ba9-bb99-b4267adc071b 54569-5864 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR SULFATE CAPSULE, GELATIN COATED ORAL 20030624 NDA NDA021567 A-S Medication Solutions LLC ATAZANAVIR SULFATE 300 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 54569-5875_e197a271-44fd-438c-b887-3b2101480353 54569-5875 HUMAN PRESCRIPTION DRUG Oxandrolone oxandrolone TABLET ORAL 20070820 ANDA ANDA077827 A-S Medication Solutions LLC OXANDROLONE 10 mg/1 CIII 54569-5877_4191aab5-8555-4cf2-b203-8e304e6a0909 54569-5877 HUMAN PRESCRIPTION DRUG BICILLIN L-A PENICILLIN G BENZATHINE INJECTION, SUSPENSION INTRAMUSCULAR 19520627 NDA NDA050141 A-S Medication Solutions LLC PENICILLIN G BENZATHINE 1200000 [iU]/2mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-5906_17094ace-b3e2-4cf8-8257-93eb6614f7d5 54569-5906 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 A-S Medication Solutions LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 54569-5907_17094ace-b3e2-4cf8-8257-93eb6614f7d5 54569-5907 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 A-S Medication Solutions LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 54569-5912_8dc9a65d-76c2-49fd-8973-b1313cc32c2f 54569-5912 HUMAN PRESCRIPTION DRUG BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET ORAL 20100721 ANDA ANDA090968 A-S Medication Solutions LLC BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 54569-5918_77544fc3-0347-491a-856e-9516828f4bf8 54569-5918 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070501 ANDA ANDA065259 A-S Medication Solutions LLC CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54569-5921_ad90fa84-dfe8-4a47-8a0c-f9bdaf896e3e 54569-5921 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20070501 ANDA ANDA065264 A-S Medication Solutions LLC CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54569-5966_a7b6d648-02b0-4906-b3c8-f9542f355dda 54569-5966 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 A-S Medication Solutions LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 54569-5967_19438913-e4f9-4215-8cc4-1e17a5439aa9 54569-5967 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 A-S Medication Solutions LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 54569-5988_cdb716c6-a2ef-4b34-905d-e172648e71b5 54569-5988 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate Butorphanol Tartrate SPRAY, METERED NASAL 20020312 ANDA ANDA075824 A-S Medication Solutions LLC BUTORPHANOL TARTRATE 10 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV 54569-6027_2df6f9fc-5e0c-4c13-a319-350093eaf576 54569-6027 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 A-S Medication Solutions LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 54569-6037_c56bb269-31bc-49a8-a017-e25f2ba490b1 54569-6037 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 A-S Medication Solutions LLC AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-6043_fc4e913d-99eb-453c-a2e7-c361b1f6d331 54569-6043 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201091 A-S Medication Solutions LLC AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54569-6044_8bcaa4a6-bd8d-4f3f-91af-91dc7cc9f2a9 54569-6044 HUMAN PRESCRIPTION DRUG Diazepam DIAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19871013 ANDA ANDA071583 A-S Medication Solutions LLC DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-6100_ca07f858-ccfa-4d33-a9a7-19fea82799d8 54569-6100 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040526 A-S Medication Solutions LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 54569-6118_5325d61f-1cf2-4bb7-a77f-b49a80621de8 54569-6118 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20080606 ANDA ANDA077239 A-S Medication Solutions LLC ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 54569-6164_1213d76e-f9d6-4d61-9660-9b7715d66367 54569-6164 HUMAN OTC DRUG Cheratussin AC codeine phosphate and guaifenesin LIQUID ORAL 19960901 OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 54569-6187_50f7047c-4afe-45fe-9f73-856109e8a704 54569-6187 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET, EXTENDED RELEASE ORAL 20110504 ANDA ANDA077391 A-S Medication Solutions LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-6231_aaceea69-9ee0-48cc-9d96-9c51764baa0e 54569-6231 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110607 ANDA ANDA078179 A-S Medication Solutions LLC ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 54569-6239_d22808bc-28ea-46d4-ad57-70bdea4e5bfb 54569-6239 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 A-S Medication Solutions LLC PREGABALIN 50 mg/1 CV 54569-6240_d22808bc-28ea-46d4-ad57-70bdea4e5bfb 54569-6240 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 A-S Medication Solutions LLC PREGABALIN 100 mg/1 CV 54569-6244_8bd52f8e-b1ac-4a9c-847e-20cf837693e3 54569-6244 HUMAN PRESCRIPTION DRUG Nuvigil armodafinil TABLET ORAL 20090601 NDA NDA021875 A-S Medication Solutions LLC ARMODAFINIL 150 mg/1 CIV 54569-6295_bd492b38-51ea-4a13-9beb-51c50260c253 54569-6295 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20090921 ANDA ANDA071251 A-S Medication Solutions LLC HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54569-6325_e77e80f1-60e9-4034-a2bc-d19592c754a2 54569-6325 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20110214 NDA NDA021306 A-S Medication Solutions LLC BUPRENORPHINE 10 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 54569-6326_e77e80f1-60e9-4034-a2bc-d19592c754a2 54569-6326 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20110214 NDA NDA021306 A-S Medication Solutions LLC BUPRENORPHINE 20 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 54569-6336_d22808bc-28ea-46d4-ad57-70bdea4e5bfb 54569-6336 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 A-S Medication Solutions LLC PREGABALIN 150 mg/1 CV 54569-6337_754251f5-fa40-4df6-ab8e-58dfa507d946 54569-6337 HUMAN PRESCRIPTION DRUG Androgel Testosterone GEL TRANSDERMAL 20110429 NDA NDA022309 A-S Medication Solutions LLC TESTOSTERONE 16.2 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 54569-6361_0c4f503e-94b3-4947-a824-9abd4750b8e8 54569-6361 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120314 NDA NDA022370 A-S Medication Solutions LLC TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 54569-6376_8126b3c9-c9d6-4310-93b0-1cce931efb02 54569-6376 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 19940601 ANDA ANDA074224 A-S Medication Solutions LLC TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54569-6378_aaceea69-9ee0-48cc-9d96-9c51764baa0e 54569-6378 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101013 ANDA ANDA078179 A-S Medication Solutions LLC ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 54569-6385_c5c453bf-b350-418a-b490-513cff8957a9 54569-6385 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20091113 ANDA ANDA078783 A-S Medication Solutions LLC TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 54569-6399_6cda900a-356d-48cc-917f-fef5d458d54f 54569-6399 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride, naloxone hydrochloride FILM, SOLUBLE SUBLINGUAL 20100913 NDA NDA022410 A-S Medication Solutions LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 54569-6401_ada15ddb-c5d6-40fc-a06e-c142d5c7dc64 54569-6401 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 A-S Medication Solutions LLC AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54569-6408_de5deb0d-2914-4adb-a6dc-b22efe996480 54569-6408 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20130222 ANDA ANDA203136 A-S Medication Solutions LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 54569-6438_8b166910-60bf-48cf-b49c-d6950fb286df 54569-6438 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 A-S Medication Solutions LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 54569-6497_a39f1688-87ff-47b0-ba61-0a2c5f526118 54569-6497 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate SOLUTION ORAL 20061001 OTC MONOGRAPH FINAL part341 A-S Medication Solutions LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 54569-6500_eb73b8e2-63be-4e0e-8a34-14d397228176 54569-6500 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20130729 ANDA ANDA040838 A-S Medication Solutions LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 54569-6543_17ff5457-dee6-43a2-8533-40b290e0441c 54569-6543 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091166 A-S Medication Solutions LLC ESZOPICLONE 2 mg/1 CIV 54569-6544_f7f78a29-0297-46fc-aadd-46fbeed2a8c5 54569-6544 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091124 A-S Medication Solutions LLC ESZOPICLONE 3 mg/1 54569-6554_bdb0b04e-859d-4bc7-9e71-5ffcb36ccbe7 54569-6554 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, and Caffeine butalbital, aspirin, and caffeine CAPSULE ORAL 20031006 NDA AUTHORIZED GENERIC NDA017534 A-S Medication Solutions LLC ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 54569-8305_aa57b377-88a9-46cc-9738-52d807ab2b5d 54569-8305 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 54569-8310_155716d0-67bd-49f0-a42f-e02dbd57809e 54569-8310 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER A-S Medication Solutions LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 54569-8311_74248ed7-221f-4c79-ab82-6e41d968e051 54569-8311 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 A-S Medication Solutions LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54569-8314_8fdff5df-1119-431e-a05f-2782e644f3a2 54569-8314 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 A-S Medication Solutions LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 54569-8318_74248ed7-221f-4c79-ab82-6e41d968e051 54569-8318 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 A-S Medication Solutions LLC CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54569-8331_f9bc03d3-d347-4ab5-80ed-bf034715d2b0 54569-8331 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19771117 ANDA ANDA085762 A-S Medication Solutions LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 54569-8336_03e1bd00-6fd0-48a0-a302-7ba4b85cbd06 54569-8336 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate ACETAMINOPHEN and CODEINE PHOSPHATE SOLUTION ORAL 19810821 ANDA ANDA087508 A-S Medication Solutions LLC ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 54569-8372_8b3e9142-8923-4a67-be3a-9756b2350204 54569-8372 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, and Caffeine butalbital, aspirin, and caffeine CAPSULE ORAL 20031006 NDA AUTHORIZED GENERIC NDA017534 A-S Medication Solutions LLC ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 54569-8704_2cd1a781-db31-409e-8af2-f555646d2b52 54569-8704 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 A-S Medication Solutions LLC PREGABALIN 50 mg/1 CV 54569-8705_2cd1a781-db31-409e-8af2-f555646d2b52 54569-8705 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 A-S Medication Solutions LLC PREGABALIN 100 mg/1 CV 54569-8707_2cd1a781-db31-409e-8af2-f555646d2b52 54569-8707 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 A-S Medication Solutions LLC PREGABALIN 150 mg/1 CV 54569-8708_2cd1a781-db31-409e-8af2-f555646d2b52 54569-8708 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 A-S Medication Solutions LLC PREGABALIN 75 mg/1 CV 54575-081_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-081 HUMAN PRESCRIPTION DRUG BAHIA GRASS POLLEN paspalum notatum pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PASPALUM NOTATUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-082_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-082 HUMAN PRESCRIPTION DRUG CULTIVATED BARLEY POLLEN hordeum vulgare pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. HORDEUM VULGARE POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-083_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-083 HUMAN PRESCRIPTION DRUG CREEPING BENT GRASS POLLEN agrostis stolonifera pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AGROSTIS STOLONIFERA POLLEN 1 g/20mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 54575-084_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-084 HUMAN PRESCRIPTION DRUG STANDARDIZED BERMUDA GRASS POLLEN Cynodon dactylon pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19970529 BLA BLA101379 Allergy Laboratories, Inc. CYNODON DACTYLON POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-085_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-085 HUMAN PRESCRIPTION DRUG ANNUAL BLUEGRASS POLLEN poa annua pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. POA ANNUA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-087_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-087 HUMAN PRESCRIPTION DRUG STANDARDIZED KENTUCKY BLUEGRASS POLLEN Poa pratensis pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19970529 BLA BLA101380 Allergy Laboratories, Inc. POA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-088_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-088 HUMAN PRESCRIPTION DRUG HUNGARIAN SMOOTH BROME POLLEN bromus inermis pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BROMUS INERMIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-089_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-089 HUMAN PRESCRIPTION DRUG CANARY GRASS POLLEN phalaris minor pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PHALARIS MINOR POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-090_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-090 HUMAN PRESCRIPTION DRUG SOUTHERN CHEAT CHESS POLLEN bromus secalinus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BROMUS SECALINUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-091_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-091 HUMAN PRESCRIPTION DRUG CULTIVATED CORN POLLEN zea mays pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ZEA MAYS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-092_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-092 HUMAN PRESCRIPTION DRUG STANDARDIZED MEADOW FESCUE GRASS POLLEN Festuca elatior pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19970529 BLA BLA101381 Allergy Laboratories, Inc. FESTUCA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-093_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-093 HUMAN PRESCRIPTION DRUG BLUE GRAMA GRASS bouteloua gracilis pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BOUTELOUA GRACILIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-094_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-094 HUMAN PRESCRIPTION DRUG JOHNSON GRASS POLLEN sorghum halepense pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SORGHUM HALEPENSE POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-095_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-095 HUMAN PRESCRIPTION DRUG TALL OAT GRASS POLLEN arrhenatherum elatius pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ARRHENATHERUM ELATIUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-096_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-096 HUMAN PRESCRIPTION DRUG CULTIVATED OATS POLLEN avena sativa pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AVENA SATIVA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-097_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-097 HUMAN PRESCRIPTION DRUG STANDARDIZED ORCHARD GRASS POLLEN Dactylis glomerata pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19970529 BLA BLA101382 Allergy Laboratories, Inc. DACTYLIS GLOMERATA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-098_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-098 HUMAN PRESCRIPTION DRUG QUACK GRASS POLLEN elymus repens pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ELYMUS REPENS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-099_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-099 HUMAN PRESCRIPTION DRUG STANDARDIZED REDTOP GRASS POLLEN Agrostis alba pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19970529 BLA BLA101383 Allergy Laboratories, Inc. AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-101_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-101 HUMAN PRESCRIPTION DRUG ITALIAN RYEGRASS POLLEN lolium perenne subsp. multiflorum pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. LOLIUM PERENNE SUBSP. MULTIFLORUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-102_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-102 HUMAN PRESCRIPTION DRUG STANDARDIZED PERENNIAL RYEGRASS GRASS POLLEN Lolium perenne pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19970625 BLA BLA101384 Allergy Laboratories, Inc. LOLIUM PERENNE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-104_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-104 HUMAN PRESCRIPTION DRUG GRAIN SORGHUM POLLEN sorghum bicolor subsp. bicolor pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SORGHUM BICOLOR SUBSP. BICOLOR POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-105_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-105 HUMAN PRESCRIPTION DRUG SUDAN GRASS POLLEN sorghum bicolor subsp. drummondii pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SORGHUM BICOLOR SUBSP. DRUMMONDII POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-106_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-106 HUMAN PRESCRIPTION DRUG STANDARDIZED SWEET VERNAL GRASS POLLEN Anthoxanthum odoratum pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19970529 BLA BLA101385 Allergy Laboratories, Inc. ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-107_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-107 HUMAN PRESCRIPTION DRUG STANDARDIZED TIMOTHY GRASS POLLEN Phleum pratense pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19970529 BLA BLA101386 Allergy Laboratories, Inc. PHLEUM PRATENSE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-109_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-109 HUMAN PRESCRIPTION DRUG CULTIVATED WHEAT POLLEN triticum aestivum pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TRITICUM AESTIVUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-110_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-110 HUMAN PRESCRIPTION DRUG WESTERN WHEAT POLLEN pascopyrum smithii pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PASCOPYRUM SMITHII POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-113_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-113 HUMAN PRESCRIPTION DRUG ALFALFA POLLEN medicago sativa pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MEDICAGO SATIVA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-114_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-114 HUMAN PRESCRIPTION DRUG SWEET CLOVER POLLEN melilotus albus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MELILOTUS ALBUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-115_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-115 HUMAN PRESCRIPTION DRUG SUGAR BEET POLLEN beta vulgaris pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BETA VULGARIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-116_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-116 HUMAN PRESCRIPTION DRUG WESTERN JUNE GRASS POLLEN koeleria macrantha pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. KOELERIA MACRANTHA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-121_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-121 HUMAN PRESCRIPTION DRUG BROOMWEED POLLEN amphiachyris dracunculoides pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMPHIACHYRIS DRACUNCULOIDES POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-122_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-122 HUMAN PRESCRIPTION DRUG CARELESS WEED POLLEN amaranthus palmeri pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMARANTHUS PALMERI POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-123_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-123 HUMAN PRESCRIPTION DRUG COCKLEBUR POLLEN xanthium strumarium pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-126_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-126 HUMAN PRESCRIPTION DRUG YELLOW CURLY DOCK POLLEN rumex crispus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. RUMEX CRISPUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-127_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-127 HUMAN PRESCRIPTION DRUG FIREBUSH KOCHIA POLLEN kochia scoparia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. KOCHIA SCOPARIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-128_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-128 HUMAN PRESCRIPTION DRUG GOLDENROD POLLEN solidago canadensis pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-129_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-129 HUMAN PRESCRIPTION DRUG GREASEWOOD POLLEN sarcobatus vermiculatus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-130_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-130 HUMAN PRESCRIPTION DRUG GROUNDSEL TREE POLLEN baccharis halimifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-131_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-131 HUMAN PRESCRIPTION DRUG NETTLE POLLEN urtica dioica pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. URTICA DIOICA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-132_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-132 HUMAN PRESCRIPTION DRUG LAMBS QUARTERS POLLEN chenopodium album pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CHENOPODIUM ALBUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-133_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-133 HUMAN PRESCRIPTION DRUG BURWEED MARSHELDER POLLEN iva xanthifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. IVA XANTHIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-134_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-134 HUMAN PRESCRIPTION DRUG NARROWLEAF MARSHELDER POLLEN iva angustifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. IVA ANGUSTIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-135_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-135 HUMAN PRESCRIPTION DRUG ROUGH MARSHELDER POLLEN iva annua var. annua pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-136_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-136 HUMAN PRESCRIPTION DRUG COMMON MUGWORT POLLEN artemisia vulgaris pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ARTEMISIA VULGARIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-137_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-137 HUMAN PRESCRIPTION DRUG SPINY PIGWEED POLLEN amaranthus spinosus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-138_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-138 HUMAN PRESCRIPTION DRUG ROUGH REDROOT PIGWEED POLLEN amaranthus retroflexus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-139_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-139 HUMAN PRESCRIPTION DRUG PIGWEED MIX, ROUGH/SPINY POLLEN amaranthus retroflexus pollen and amaranthus spinosus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN .5; .5 g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-140_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-140 HUMAN PRESCRIPTION DRUG ENGLISH PLANTAIN POLLEN plantago lanceolata pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-145_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-145 HUMAN PRESCRIPTION DRUG FALSE BUR RAGWEED POLLEN ambrosia acanthicarpa pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-146_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-146 HUMAN PRESCRIPTION DRUG GIANT RAGWEED POLLEN ambrosia trifida pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMBROSIA TRIFIDA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-147_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-147 HUMAN PRESCRIPTION DRUG STANDARDIZED SHORT RAGWEED POLLEN ambrosia artemisiifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19820126 BLA BLA101387 Allergy Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 1 g/10mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-150_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-150 HUMAN PRESCRIPTION DRUG WESTERN RAGWEED POLLEN ambrosia psilostachya pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-153_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-153 HUMAN PRESCRIPTION DRUG 3-RAGWEED MIX, GIANT/SHORT/WESTERN POLLEN ambrosia psilostachya pollen and ambrosia trifida pollen and ambrosia artemisiifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN .34; .33; .33 g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-154_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-154 HUMAN PRESCRIPTION DRUG RUSSIAN THISTLE POLLEN salsola kali pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SALSOLA KALI POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-155_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-155 HUMAN PRESCRIPTION DRUG COMMON BIG SAGEBRUSH POLLEN artemisia tridentata pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-158_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-158 HUMAN PRESCRIPTION DRUG PRAIRIE SAGE POLLEN artemisia frigida pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ARTEMISIA FRIGIDA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-159_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-159 HUMAN PRESCRIPTION DRUG SAGE MIX, COMMON/DARK-LEAVED/DRAGON/PASTURE POLLEN artemisia ludoviciana pollen and artemisia tridentata pollen and artemisia dracunculus pollen and artemisia frigida pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ARTEMISIA DRACUNCULUS POLLEN; ARTEMISIA FRIGIDA POLLEN; ARTEMISIA LUDOVICIANA POLLEN; ARTEMISIA TRIDENTATA POLLEN .25; .25; .25; .25 g/20mL; g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-160_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-160 HUMAN PRESCRIPTION DRUG ANNUAL SALTBUSH POLLEN atriplex wrightii pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-161_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-161 HUMAN PRESCRIPTION DRUG SHADSCALE POLLEN atriplex confertifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ATRIPLEX CONFERTIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-162_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-162 HUMAN PRESCRIPTION DRUG SOUR DOCK SHEEP SORREL POLLEN rumex acetosella pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. RUMEX ACETOSELLA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 54575-163_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-163 HUMAN PRESCRIPTION DRUG WATER HEMP POLLEN amaranthus tuberculatus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-164_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-164 HUMAN PRESCRIPTION DRUG WINGSCALE POLLEN atriplex canescens pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ATRIPLEX CANESCENS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-166_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-166 HUMAN PRESCRIPTION DRUG ANNUAL WORMWOOD POLLEN artemisia annua pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ARTEMISIA ANNUA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-167_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-167 HUMAN PRESCRIPTION DRUG COMMON WORMWOOD POLLEN artemisia absinthium pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-168_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-168 HUMAN PRESCRIPTION DRUG MEXICAN TEA POLLEN chenopodium ambrosioides pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-169_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-169 HUMAN PRESCRIPTION DRUG DOCK MIX, SOUR SHEEP SORREL/YELLOW POLLEN rumex acetosella pollen and rumex crispus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN .5; .5 g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-170_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-170 HUMAN PRESCRIPTION DRUG STANDARDIZED RAGWEED MIX, GIANT/SHORT ambrosia trifida pollen and ambrosia artemisiifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN .5; .5 g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-175_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-175 HUMAN PRESCRIPTION DRUG DANDELION POLLEN taraxacum officinale pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TARAXACUM OFFICINALE POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-179_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-179 HUMAN PRESCRIPTION DRUG SUNFLOWER POLLEN helianthus annuus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. HELIANTHUS ANNUUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-181_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-181 HUMAN PRESCRIPTION DRUG ALTERNARIA TENUIS ALTERNATA alternaria alternata INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ALTERNARIA ALTERNATA 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-182_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-182 HUMAN PRESCRIPTION DRUG ASPERGILLUS FUMIGATUS aspergillus fumigatus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ASPERGILLUS FUMIGATUS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-183_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-183 HUMAN PRESCRIPTION DRUG ASPERGILLUS GLAUCUS eurotium herbariorum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. EUROTIUM HERBARIORUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-184_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-184 HUMAN PRESCRIPTION DRUG ASPERGILLUS NIGER aspergillus niger var. niger INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-185_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-185 HUMAN PRESCRIPTION DRUG ASPERGILLUS TERREUS aspergillus terreus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ASPERGILLUS TERREUS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-186_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-186 HUMAN PRESCRIPTION DRUG PULLULARIA PULLULANS aureobasidium pullulans var. pullutans INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-187_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-187 HUMAN PRESCRIPTION DRUG BOTRYTIS CINEREA botrytis cinerea INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BOTRYTIS CINEREA 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-188_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-188 HUMAN PRESCRIPTION DRUG CANDIDA MONILA ALBICANS candida albicans INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CANDIDA ALBICANS 1 g/20mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 54575-189_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-189 HUMAN PRESCRIPTION DRUG CEPHALOSPORIUM ACREMONIUM acremonium strictum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ACREMONIUM STRICTUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-190_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-190 HUMAN PRESCRIPTION DRUG CEPHALOTHECIUM ROSEUM trichothecium roseum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TRICHOTHECIUM ROSEUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-191_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-191 HUMAN PRESCRIPTION DRUG CHAETOMIUM GLOBOSUM chaetomium globosum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CHAETOMIUM GLOBOSUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-192_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-192 HUMAN PRESCRIPTION DRUG CLADOSPORIUM FULVUM passalora fulva INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PASSALORA FULVA 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-193_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-193 HUMAN PRESCRIPTION DRUG CURVULARIA SPICIFERA cochliobolus spicifer INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. COCHLIOBOLUS SPICIFER 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-194_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-194 HUMAN PRESCRIPTION DRUG EPICOCCUM NIGRUM epicoccum nigrum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. EPICOCCUM NIGRUM 1 g/20mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 54575-195_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-195 HUMAN PRESCRIPTION DRUG EPIDERMOPHYTON FLOCCOSUM epidermophyton floccosum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. EPIDERMOPHYTON FLOCCOSUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-196_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-196 HUMAN PRESCRIPTION DRUG FUSARIUM VASINFECTUM OXYSPORUM fusarium oxysporum vasinfectum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. FUSARIUM OXYSPORUM VASINFECTUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-197_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-197 HUMAN PRESCRIPTION DRUG FUSARIUM SOLANI haematonectria haematococca INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. HAEMATONECTRIA HAEMATOCOCCA 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-199_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-199 HUMAN PRESCRIPTION DRUG GEOTRICHUM CANDIDUM geotrichum candidum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. GEOTRICHUM CANDIDUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-201_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-201 HUMAN PRESCRIPTION DRUG HELMINTHOSPORIUM SATIVUM cochliobolus sativus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. COCHLIOBOLUS SATIVUS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-202_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-202 HUMAN PRESCRIPTION DRUG HORMODENDRUM CLADOSPORIUM CLADOSPORIOIDES cladosporium cladosporioides INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-208_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-208 HUMAN PRESCRIPTION DRUG MUCOR PLUMBEUS mucor plumbeus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MUCOR PLUMBEUS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-209_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-209 HUMAN PRESCRIPTION DRUG MUCOR RACEMOSUS mucor racemosus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MUCOR RACEMOSUS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-211_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-211 HUMAN PRESCRIPTION DRUG NEUROSPORA SITOPHILA neurospora sitophila INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. NEUROSPORA SITOPHILA 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-212_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-212 HUMAN PRESCRIPTION DRUG NIGROSPORA SPHAERICA khuskia oryzae INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. KHUSKIA ORYZAE 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-214_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-214 HUMAN PRESCRIPTION DRUG PENICILLIUM NOTATUM CHRYSOGENUM penicillium chrysogenum var. chrysogenum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-216_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-216 HUMAN PRESCRIPTION DRUG PHOMA DESTRUCTIVA phoma destructiva INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PHOMA DESTRUCTIVA 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-217_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-217 HUMAN PRESCRIPTION DRUG RHIZOPUS NIGRICANS rhizopus stolonifer INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. RHIZOPUS STOLONIFER 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-218_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-218 HUMAN PRESCRIPTION DRUG RHODOTORULA MUCILAGINOSA rhodotorula mucilaginosa INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. RHODOTORULA MUCILAGINOSA 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-220_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-220 HUMAN PRESCRIPTION DRUG SPONDYLOCLADIUM ATROVIRENS helminthosporium solani INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. HELMINTHOSPORIUM SOLANI 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-222_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-222 HUMAN PRESCRIPTION DRUG STEMPHYLIUM SARCINIFORME stemphylium sarciniforme INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. STEMPHYLIUM SARCINIFORME 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-223_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-223 HUMAN PRESCRIPTION DRUG TRICHODERMA LIGNORUM trichoderma viride INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TRICHODERMA VIRIDE 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-224_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-224 HUMAN PRESCRIPTION DRUG TRICHOPHYTON MENTAGROPHYTES trichophyton mentagrophytes INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-225_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-225 HUMAN PRESCRIPTION DRUG TRICHOPHYTON RUBRUM trichophyton rubrum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TRICHOPHYTON RUBRUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-226_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-226 HUMAN PRESCRIPTION DRUG TRICHOPHYTON TONSURANS trichophyton tonsurans INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TRICHOPHYTON TONSURANS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-227_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-227 HUMAN PRESCRIPTION DRUG VERTICILLIUM ALBO ATRUM verticillium albo-atrum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. VERTICILLIUM ALBO-ATRUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-228_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-228 HUMAN PRESCRIPTION DRUG RINKEL MOLD MIX A aspergillus fumigatus and botrytis cinerea and chaetomium globosum and epicoccum nigrum and fusarium oxysporum vasinfectum and cochliobolus sativus and neurospora sitophila and mucor plumbeus and phom INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; COCHLIOBOLUS SATIVUS; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM VASINFECTUM; GEOTRICHUM CANDIDUM; MUCOR PLUMBEUS; NEUROSPORA SITOPHILA; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA EXIGUA VAR. EXIGUA; RHIZOPUS STOLONIFER; RHODOTORULA MUCILAGINOSA; SACCHAROMYCES CEREVISIAE .066; .067; .066; .066; .067; .066; .066; .067; .067; .067; .067; .067; .067; .067; .067 g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-229_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-229 HUMAN PRESCRIPTION DRUG RINKEL MOLD MIX B trichothecium roseum and passalora fulva and cochliobolus spicifer and myrothecium verrucaria and trichophyton schoenleinii and mycogone nigra and neurospora crassa and khuskia oryzae and paecilomyces INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. COCHLIOBOLUS SPICIFER; HELMINTHOSPORIUM SOLANI; KHUSKIA ORYZAE; MICROASCUS BREVICAULIS; MYCOGONE NIGRA; MYROTHECIUM VERRUCARIA; NEUROSPORA CRASSA; PAECILOMYCES VARIOTII; PASSALORA FULVA; PLEOSPORA TARDA; STREPTOMYCES GRISEUS; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII; TRICHOTHECIUM ROSEUM .071; .072; .071; .072; .071; .071; .071; .072; .071; .072; .072; .072; .071; .071 g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-230_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-230 HUMAN PRESCRIPTION DRUG RINKEL MOLD MIX C absidia capillata and acrothecium robustum and microsporum audouinii and microsporum canis and apiospora montagnei and phycomyces blakesleeanus and sporotrichum pruinosum and stachybotrys chartarum an INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ABSIDIA CAPILLATA; ACROTHECIUM ROBUSTUM; APIOSPORA MONTAGNEI; MICROSPORUM AUDOUINII; MICROSPORUM CANIS; PHYCOMYCES BLAKESLEEANUS; SPOROTRICHUM PRUINOSUM; STACHYBOTRYS CHARTARUM; SYNCEPHALASTRUM RACEMOSUM; TETRACOCCOSPORIUM PAXIANUM; THERMOMYCES LANUGINOSUS; TRICHOSPORON CUTANEUM; VERTICILLIUM ALBO-ATRUM .076; .077; .077; .077; .077; .077; .077; .077; .077; .077; .077; .077; .077 g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-240_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-240 HUMAN PRESCRIPTION DRUG BERMUDA GRASS SMUT ustilago cynodontis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. USTILAGO CYNODONTIS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-241_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-241 HUMAN PRESCRIPTION DRUG CORN SMUT ustilago maydis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. USTILAGO MAYDIS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-243_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-243 HUMAN PRESCRIPTION DRUG JOHNSON GRASS SMUT sporisorium cruentum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SPORISORIUM CRUENTUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-248_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-248 HUMAN PRESCRIPTION DRUG WHEAT RUST puccinia graminis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PUCCINIA GRAMINIS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-257_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-257 HUMAN PRESCRIPTION DRUG COTTON SEED FOR DIAGNOSTIC USE ONLY cotton seed INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. COTTON SEED 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 54575-259_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-259 HUMAN PRESCRIPTION DRUG FLAX SEED FOR DIAGNOSTIC USE ONLY flax seed INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. FLAX SEED 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 54575-267_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-267 HUMAN PRESCRIPTION DRUG HOUSE DUST house dust INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. HOUSE DUST 1 g/20mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 54575-270_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-270 HUMAN PRESCRIPTION DRUG KAPOK ceiba pentandra fiber INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CEIBA PENTANDRA FIBER 1 g/20mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-272_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-272 HUMAN PRESCRIPTION DRUG ORRIS ROOT iris germanica var. florentina root INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. IRIS GERMANICA VAR. FLORENTINA ROOT 1 g/20mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient] 54575-273_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-273 HUMAN PRESCRIPTION DRUG PYRETHRUM tanacetum cinerariifolium flower INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TANACETUM CINERARIIFOLIUM FLOWER 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 54575-278_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-278 HUMAN PRESCRIPTION DRUG SILK bombyx mori fiber INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BOMBYX MORI FIBER 1 g/20mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Silk [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-284_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-284 HUMAN PRESCRIPTION DRUG COTTON LINTERS cotton fiber INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. COTTON FIBER 1 g/20mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-288_26d83173-bf33-4460-ac59-b46f052d9787 54575-288 HUMAN PRESCRIPTION DRUG Standardized Cat Hair Felis Domesticus Hair INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19921030 BLA BLA103324 Allergy Laboratories, Inc. FELIS CATUS HAIR 10000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] 54575-289_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-289 HUMAN PRESCRIPTION DRUG CATTLE HAIR AND EPITHELIA bos taurus hair and bos taurus skin INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BOS TAURUS HAIR; BOS TAURUS SKIN 1; 1 g/20mL; g/20mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-291_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-291 HUMAN PRESCRIPTION DRUG DOG HAIR AND EPITHELIA canis lupus familiaris hair and canis lupus familiaris skin INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR; CANIS LUPUS FAMILIARIS SKIN 1; 1 g/20mL; g/20mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-293_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-293 HUMAN PRESCRIPTION DRUG CHICKEN FEATHERS gallus gallus feather INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. GALLUS GALLUS FEATHER 1 g/20mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-294_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-294 HUMAN PRESCRIPTION DRUG DUCK FEATHERS anas platyrhynchos feather INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER 1 g/20mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-295_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-295 HUMAN PRESCRIPTION DRUG GOOSE FEATHERS anser anser feather INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ANSER ANSER FEATHER 1 g/20mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-296_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-296 HUMAN PRESCRIPTION DRUG FEATHER MIX, CHICKEN/DUCK/GOOSE gallus gallus feather and anas platyrhynchos feather and anser anser feather INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; GALLUS GALLUS FEATHER .33; .34; .33 g/20mL; g/20mL; g/20mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-299_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-299 HUMAN PRESCRIPTION DRUG GUINEA PIG HAIR AND EPITHELIA cavia porcellus hair and cavia porcellus skin INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CAVIA PORCELLUS HAIR; CAVIA PORCELLUS SKIN .5; .5 g/20mL; g/20mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-300_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-300 HUMAN PRESCRIPTION DRUG HAMSTER HAIR AND EPITHELIA mesocricetus auratus skin INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MESOCRICETUS AURATUS SKIN 1 g/20mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-301_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-301 HUMAN PRESCRIPTION DRUG HOG HAIR AND EPITHELIA sus scrofa hair and sus scrofa skin INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SUS SCROFA HAIR; SUS SCROFA SKIN 1; 1 g/20mL; g/20mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-302_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-302 HUMAN PRESCRIPTION DRUG HORSE HAIR AND DANDER equus caballus hair and equus caballus skin INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. EQUUS CABALLUS HAIR; EQUUS CABALLUS SKIN .5; .5 g/20mL; g/20mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-305_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-305 HUMAN PRESCRIPTION DRUG MOUSE HAIR AND EPITHELIA mus musculus skin INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MUS MUSCULUS SKIN 1 g/50mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-306_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-306 HUMAN PRESCRIPTION DRUG RABBIT HAIR AND EPITHELIA oryctolagus cuniculus hair and oryctolagus cuniculus skin INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ORYCTOLAGUS CUNICULUS HAIR; ORYCTOLAGUS CUNICULUS SKIN .5; .5 g/20mL; g/20mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-315_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-315 HUMAN PRESCRIPTION DRUG FIRE ANT solenopsis invicta INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SOLENOPSIS INVICTA 1 g/20mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-318_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-318 HUMAN PRESCRIPTION DRUG AMERICAN COCKROACH periplaneta americana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PERIPLANETA AMERICANA 1 g/20mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-319_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-319 HUMAN PRESCRIPTION DRUG GERMAN COCKROACH blatella germanica INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BLATELLA GERMANICA 1 g/20mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-321_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-321 HUMAN PRESCRIPTION DRUG HOUSEFLY FOR DIAGNOSTIC USE ONLY musca domestica INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MUSCA DOMESTICA 1 g/50mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-324_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-324 HUMAN PRESCRIPTION DRUG MOSQUITO FOR DIAGNOSTIC USE ONLY aedes taeniorhynchus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AEDES TAENIORHYNCHUS 1 g/20mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-325_c268f64e-7114-4227-a030-0fe9f4def162 54575-325 HUMAN PRESCRIPTION DRUG STANDARDIZED MITE D FARINAE Dermatophagoides farinae INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19890125 BLA BLA101377 Allergy Laboratories, Inc. DERMATOPHAGOIDES FARINAE 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-326_c268f64e-7114-4227-a030-0fe9f4def162 54575-326 HUMAN PRESCRIPTION DRUG STANDARDIZED MITE D PTERONYSSINUS Dermatophagoides pteronyssinus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19911211 BLA BLA101378 Allergy Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-333_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-333 HUMAN PRESCRIPTION DRUG ALMOND almond INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ALMOND 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 54575-335_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-335 HUMAN PRESCRIPTION DRUG APPLE apple INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. APPLE 1 g/20mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] 54575-336_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-336 HUMAN PRESCRIPTION DRUG APRICOT apricot INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. APRICOT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-338_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-338 HUMAN PRESCRIPTION DRUG AVOCADO avocado INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AVOCADO 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-339_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-339 HUMAN PRESCRIPTION DRUG BANANA banana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BANANA 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-340_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-340 HUMAN PRESCRIPTION DRUG BARLEY FOOD barley INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BARLEY 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 54575-341_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-341 HUMAN PRESCRIPTION DRUG BASIL basil INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BASIL 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 54575-342_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-342 HUMAN PRESCRIPTION DRUG BLACK BASS largemouth bass INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. LARGEMOUTH BASS 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 54575-344_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-344 HUMAN PRESCRIPTION DRUG LIMA BEAN lima bean INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. LIMA BEAN 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 54575-345_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-345 HUMAN PRESCRIPTION DRUG NAVY BEAN kidney bean INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. KIDNEY BEAN 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-346_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-346 HUMAN PRESCRIPTION DRUG PINTO BEAN kidney bean INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. KIDNEY BEAN 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-347_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-347 HUMAN PRESCRIPTION DRUG RED KIDNEY BEAN kidney bean INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. KIDNEY BEAN 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-348_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-348 HUMAN PRESCRIPTION DRUG SOYBEAN soybean INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SOYBEAN 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-349_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-349 HUMAN PRESCRIPTION DRUG GREEN STRING BEAN string bean INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. STRING BEAN 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 54575-350_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-350 HUMAN PRESCRIPTION DRUG BEEF beef INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BEEF 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 54575-353_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-353 HUMAN PRESCRIPTION DRUG BLACKBERRY blackberry INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BLACKBERRY 1 g/20mL 54575-354_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-354 HUMAN PRESCRIPTION DRUG BLUEBERRY blue ridge blueberry INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BLUE RIDGE BLUEBERRY 1 g/20mL 54575-356_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-356 HUMAN PRESCRIPTION DRUG BROCCOLI broccoli INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BROCCOLI 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-357_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-357 HUMAN PRESCRIPTION DRUG BRUSSEL SPROUTS brussels sprout INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BRUSSELS SPROUT 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-358_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-358 HUMAN PRESCRIPTION DRUG BUCKWHEAT buckwheat INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BUCKWHEAT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 54575-359_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-359 HUMAN PRESCRIPTION DRUG CABBAGE cabbage INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CABBAGE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-360_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-360 HUMAN PRESCRIPTION DRUG CANTALOUPE cantaloupe INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CANTALOUPE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-362_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-362 HUMAN PRESCRIPTION DRUG CARROT carrot INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CARROT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-364_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-364 HUMAN PRESCRIPTION DRUG CASHEW NUT cashew INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CASHEW 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 54575-365_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-365 HUMAN PRESCRIPTION DRUG CATFISH catfish INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CATFISH 1 g/20mL 54575-366_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-366 HUMAN PRESCRIPTION DRUG CAULIFLOWER cauliflower INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CAULIFLOWER 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-367_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-367 HUMAN PRESCRIPTION DRUG CELERY celery INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CELERY 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-371_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-371 HUMAN PRESCRIPTION DRUG CHERRY FOOD cherry INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CHERRY 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-372_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-372 HUMAN PRESCRIPTION DRUG CHICKEN FOOD chicken INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CHICKEN 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 54575-374_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-374 HUMAN PRESCRIPTION DRUG CINNAMON cinnamon INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CINNAMON 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-375_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-375 HUMAN PRESCRIPTION DRUG CLAM quahog INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUAHOG 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 54575-377_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-377 HUMAN PRESCRIPTION DRUG CACAO BEAN cocoa INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. COCOA 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 54575-378_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-378 HUMAN PRESCRIPTION DRUG COCONUT coconut INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. COCONUT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-379_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-379 HUMAN PRESCRIPTION DRUG CODFISH cod INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. COD 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 54575-380_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-380 HUMAN PRESCRIPTION DRUG COFFEE FOR DIAGNOSTIC USE ONLY coffee bean INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. COFFEE BEAN 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 54575-381_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-381 HUMAN PRESCRIPTION DRUG CORN FOOD corn INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CORN 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 54575-382_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-382 HUMAN PRESCRIPTION DRUG CRAB MEAT blue crab INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BLUE CRAB 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 54575-383_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-383 HUMAN PRESCRIPTION DRUG CRANBERRY cranberry INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CRANBERRY 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-385_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-385 HUMAN PRESCRIPTION DRUG CUCUMBER cucumber INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CUCUMBER 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-387_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-387 HUMAN PRESCRIPTION DRUG DATE date INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. DATE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-388_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-388 HUMAN PRESCRIPTION DRUG DILL SEED dill INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. DILL 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 54575-389_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-389 HUMAN PRESCRIPTION DRUG EGG WHITE egg white INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. EGG WHITE 1 g/20mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 54575-390_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-390 HUMAN PRESCRIPTION DRUG WHOLE EGG egg INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. EGG 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] 54575-391_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-391 HUMAN PRESCRIPTION DRUG EGG YOLK egg yolk INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. EGG YOLK 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] 54575-394_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-394 HUMAN PRESCRIPTION DRUG FLOUNDER flounder INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. FLOUNDER 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 54575-395_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-395 HUMAN PRESCRIPTION DRUG GARLIC garlic INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. GARLIC 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 54575-397_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-397 HUMAN PRESCRIPTION DRUG GINGER ginger INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. GINGER 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 54575-398_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-398 HUMAN PRESCRIPTION DRUG GRAPE concord grape INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CONCORD GRAPE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-399_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-399 HUMAN PRESCRIPTION DRUG GRAPEFRUIT grapefruit INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. GRAPEFRUIT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-400_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-400 HUMAN PRESCRIPTION DRUG HADDOCK haddock INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. HADDOCK 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 54575-401_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-401 HUMAN PRESCRIPTION DRUG HALIBUT pacific halibut INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PACIFIC HALIBUT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 54575-405_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-405 HUMAN PRESCRIPTION DRUG HORSERADISH horseradish INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. HORSERADISH 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 54575-406_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-406 HUMAN PRESCRIPTION DRUG LEMON lemon INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. LEMON 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-407_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-407 HUMAN PRESCRIPTION DRUG LETTUCE lettuce INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. LETTUCE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-408_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-408 HUMAN PRESCRIPTION DRUG LIME lime, citrus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. LIME (CITRUS) 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-410_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-410 HUMAN PRESCRIPTION DRUG BARLEY MALT barley malt INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BARLEY MALT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 54575-412_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-412 HUMAN PRESCRIPTION DRUG COW MILK cow milk INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. COW MILK 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] 54575-414_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-414 HUMAN PRESCRIPTION DRUG MUSHROOM FOOD cultivated mushroom INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CULTIVATED MUSHROOM 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 54575-415_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-415 HUMAN PRESCRIPTION DRUG MUSTARD SEED mustard seed INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. MUSTARD SEED 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 54575-418_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-418 HUMAN PRESCRIPTION DRUG OATS FOOD oat INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. OAT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 54575-420_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-420 HUMAN PRESCRIPTION DRUG GREEN OLIVE green olive INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. GREEN OLIVE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-422_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-422 HUMAN PRESCRIPTION DRUG ONION onion INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. ONION 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-423_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-423 HUMAN PRESCRIPTION DRUG ORANGE FOOD orange INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ORANGE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-424_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-424 HUMAN PRESCRIPTION DRUG OREGANO oregano INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. OREGANO 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 54575-426_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-426 HUMAN PRESCRIPTION DRUG PAPAYA papaya INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PAPAYA 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-428_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-428 HUMAN PRESCRIPTION DRUG PARSLEY parsley INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PARSLEY 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-430_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-430 HUMAN PRESCRIPTION DRUG BLACKEYED PEA black-eyed pea INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BLACK-EYED PEA 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 54575-431_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-431 HUMAN PRESCRIPTION DRUG GREEN PEA pea INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PEA 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-432_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-432 HUMAN PRESCRIPTION DRUG PEACH peach INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PEACH 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-433_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-433 HUMAN PRESCRIPTION DRUG PEANUT FOOD peanut INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PEANUT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 54575-434_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-434 HUMAN PRESCRIPTION DRUG PEAR pear INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PEAR 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-435_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-435 HUMAN PRESCRIPTION DRUG PECAN FOOD pecan INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PECAN 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 54575-436_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-436 HUMAN PRESCRIPTION DRUG BLACK PEPPER black pepper INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BLACK PEPPER 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-437_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-437 HUMAN PRESCRIPTION DRUG GREEN PEPPER green bell pepper INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. GREEN BELL PEPPER 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-438_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-438 HUMAN PRESCRIPTION DRUG PERCH perch INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PERCH 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 54575-439_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-439 HUMAN PRESCRIPTION DRUG PIMENTO red bell pepper INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. RED BELL PEPPER 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-440_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-440 HUMAN PRESCRIPTION DRUG PINEAPPLE pineapple INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PINEAPPLE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-442_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-442 HUMAN PRESCRIPTION DRUG POPPY SEED poppy seed INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. POPPY SEED 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 54575-443_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-443 HUMAN PRESCRIPTION DRUG PORK pork INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PORK 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 54575-444_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-444 HUMAN PRESCRIPTION DRUG SWEET POTATO sweet potato INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SWEET POTATO 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-445_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-445 HUMAN PRESCRIPTION DRUG WHITE POTATO potato INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. POTATO 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-449_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-449 HUMAN PRESCRIPTION DRUG RADISH radish INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. RADISH 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-451_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-451 HUMAN PRESCRIPTION DRUG RHUBARB rhubarb INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. RHUBARB 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 54575-452_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-452 HUMAN PRESCRIPTION DRUG RICE FOOD rice INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. RICE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 54575-453_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-453 HUMAN PRESCRIPTION DRUG RYE FOOD rye INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. RYE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 54575-454_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-454 HUMAN PRESCRIPTION DRUG SAGE FOOD sage INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SAGE 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 54575-455_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-455 HUMAN PRESCRIPTION DRUG PACIFIC SALMON pink salmon INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PINK SALMON 1 g/20mL 54575-456_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-456 HUMAN PRESCRIPTION DRUG SCALLOP scallop INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SCALLOP 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 54575-457_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-457 HUMAN PRESCRIPTION DRUG SESAME SEED sesame seed INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SESAME SEED 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 54575-458_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-458 HUMAN PRESCRIPTION DRUG SHRIMP shrimp INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SHRIMP 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 54575-459_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-459 HUMAN PRESCRIPTION DRUG SPEARMINT spearmint INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SPEARMINT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 54575-460_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-460 HUMAN PRESCRIPTION DRUG SPINACH spinach INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SPINACH 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-461_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-461 HUMAN PRESCRIPTION DRUG YELLOW SQUASH squash INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SQUASH 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-462_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-462 HUMAN PRESCRIPTION DRUG STRAWBERRY strawberry INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. STRAWBERRY 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-463_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-463 HUMAN PRESCRIPTION DRUG SUNFLOWER SEED sunflower seed INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SUNFLOWER SEED 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 54575-465_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-465 HUMAN PRESCRIPTION DRUG THYME thyme INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. THYME 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-466_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-466 HUMAN PRESCRIPTION DRUG TOMATO tomato INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. TOMATO 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 54575-467_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-467 HUMAN PRESCRIPTION DRUG LAKE TROUT trout INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. TROUT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 54575-468_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-468 HUMAN PRESCRIPTION DRUG TUNA tuna INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. TUNA 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 54575-469_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-469 HUMAN PRESCRIPTION DRUG TURKEY FOOD turkey INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. TURKEY 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 54575-471_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-471 HUMAN PRESCRIPTION DRUG VANILLA vanilla INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. VANILLA 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-472_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-472 HUMAN PRESCRIPTION DRUG BLACK WALNUT FOOD black walnut INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BLACK WALNUT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 54575-473_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-473 HUMAN PRESCRIPTION DRUG ENGLISH WALNUT FOOD english walnut INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. ENGLISH WALNUT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 54575-474_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-474 HUMAN PRESCRIPTION DRUG WATERMELON watermelon INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. WATERMELON 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 54575-476_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-476 HUMAN PRESCRIPTION DRUG WHOLE WHEAT FOOD wheat INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. WHEAT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 54575-486_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-486 HUMAN PRESCRIPTION DRUG PEPPERMINT peppermint INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PEPPERMINT 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 54575-901_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-901 HUMAN PRESCRIPTION DRUG ACACIA POLLEN acacia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ACACIA 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-902_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-902 HUMAN PRESCRIPTION DRUG RED ALDER POLLEN alnus rubra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ALNUS RUBRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-903_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-903 HUMAN PRESCRIPTION DRUG SMOOTH ALDER POLLEN alnus incana subsp. rugosa pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-904_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-904 HUMAN PRESCRIPTION DRUG ARIZONA ASH POLLEN fraxinus velutina pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. FRAXINUS VELUTINA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-905_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-905 HUMAN PRESCRIPTION DRUG GREEN RED ASH POLLEN fraxinus pennsylvanica pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. FRAXINUS PENNSYLVANICA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-906_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-906 HUMAN PRESCRIPTION DRUG WHITE ASH POLLEN fraxinus americana pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. FRAXINUS AMERICANA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-907_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-907 HUMAN PRESCRIPTION DRUG ASH MIX, GREEN/WHITE POLLEN fraxinus americana pollen and fraxinus pennsylvanica pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN .5; .5 g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-908_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-908 HUMAN PRESCRIPTION DRUG QUAKING ASPEN POLLEN populus tremuloides pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. POPULUS TREMULOIDES POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-909_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-909 HUMAN PRESCRIPTION DRUG BAYBERRY POLLEN morella cerifera pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MORELLA CERIFERA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-910_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-910 HUMAN PRESCRIPTION DRUG AMERICAN BEECH POLLEN fagus grandifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-912_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-912 HUMAN PRESCRIPTION DRUG RIVER BIRCH POLLEN betula nigra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BETULA NIGRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-913_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-913 HUMAN PRESCRIPTION DRUG BIRCH MIX, RIVER/PAPER/SWEET/WHITE POLLEN betula nigra pollen and betula papyrifera pollen and betula lenta pollen and betula populifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA POPULIFOLIA POLLEN .25; .25; .25; .25 g/20mL; g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-914_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-914 HUMAN PRESCRIPTION DRUG BOX ELDER POLLEN acer negundo pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ACER NEGUNDO POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-915_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-915 HUMAN PRESCRIPTION DRUG MOUNTAIN CEDAR POLLEN juniperus ashei pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. JUNIPERUS ASHEI POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-916_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-916 HUMAN PRESCRIPTION DRUG PINCHOT CEDAR POLLEN juniperus pinchotii pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-917_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-917 HUMAN PRESCRIPTION DRUG RED CEDAR POLLEN juniperus virginiana pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-919_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-919 HUMAN PRESCRIPTION DRUG EASTERN COTTONWOOD POLLEN populus deltoides pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. POPULUS DELTOIDES POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-920_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-920 HUMAN PRESCRIPTION DRUG WESTERN COTTONWOOD POLLEN populus deltoides subsp. monilifera pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-921_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-921 HUMAN PRESCRIPTION DRUG COTTONWOOD MIX, EASTERN/WESTERN POLLEN populus deltoides subsp. monilifera pollen and populus deltoides pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. POPULUS DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN .5; .5 g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-922_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-922 HUMAN PRESCRIPTION DRUG ARIZONA CYPRESS POLLEN cupressus arizonica pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-923_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-923 HUMAN PRESCRIPTION DRUG BALD CYPRESS POLLEN taxodium distichum pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TAXODIUM DISTICHUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-924_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-924 HUMAN PRESCRIPTION DRUG AMERICAN ELM POLLEN ulmus americana pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ULMUS AMERICANA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-925_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-925 HUMAN PRESCRIPTION DRUG CEDAR FALL BLOOMING ELM POLLEN ulmus crassifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-926_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-926 HUMAN PRESCRIPTION DRUG CHINESE SIBERIAN ELM POLLEN ulmus pumila pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ULMUS PUMILA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-928_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-928 HUMAN PRESCRIPTION DRUG ELM MIX, AMERICAN/CHINESE/SLIPPERY POLLEN ulmus pumila pollen and ulmus americana pollen and ulmus rubra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN; ULMUS RUBRA POLLEN .33; .33; .34 g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-929_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-929 HUMAN PRESCRIPTION DRUG EUCALYPTUS BLUE GUM POLLEN eucalyptus globulus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-930_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-930 HUMAN PRESCRIPTION DRUG DOUGLAS FIR POLLEN pseudotsuga menziesii pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PSEUDOTSUGA MENZIESII POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-932_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-932 HUMAN PRESCRIPTION DRUG SWEETGUM POLLEN liquidambar styraciflua pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-933_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-933 HUMAN PRESCRIPTION DRUG HACKBERRY POLLEN celtis occidentalis pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-935_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-935 HUMAN PRESCRIPTION DRUG SHAGBARK HICKORY POLLEN carya ovata pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CARYA OVATA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-936_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-936 HUMAN PRESCRIPTION DRUG WHITE HICKORY POLLEN carya tomentosa pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CARYA TOMENTOSA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-937_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-937 HUMAN PRESCRIPTION DRUG HICKORY MIX, PIGNUT/SHAGBARK/SHELLBARK/WHITE POLLEN carya tomentosa pollen and carya laciniosa pollen and carya ovata pollen and carya glabra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CARYA GLABRA POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CARYA TOMENTOSA POLLEN .25; .25; .25; .25 g/20mL; g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-938_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-938 HUMAN PRESCRIPTION DRUG ONE SEED JUNIPER POLLEN juniperus monosperma pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-939_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-939 HUMAN PRESCRIPTION DRUG ROCKY MOUNTAIN JUNIPER POLLEN juniperus scopulorum pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-940_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-940 HUMAN PRESCRIPTION DRUG WHITE GRAY BIRCH POLLEN betula populifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BETULA POPULIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-941_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-941 HUMAN PRESCRIPTION DRUG SUGAR HARD MAPLE POLLEN acer saccharum pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ACER SACCHARUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-943_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-943 HUMAN PRESCRIPTION DRUG MAPLE MIX, RED/SILVER/SUGAR POLLEN acer saccharum pollen and acer saccharinum pollen and acer rubrum pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN .34; .33; .33 g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-944_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-944 HUMAN PRESCRIPTION DRUG MESQUITE POLLEN prosopis juliflora pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PROSOPIS JULIFLORA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-945_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-945 HUMAN PRESCRIPTION DRUG PAPER MULBERRY POLLEN broussonetia papyrifera pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-946_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-946 HUMAN PRESCRIPTION DRUG RED MULBERRY POLLEN morus rubra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MORUS RUBRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-947_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-947 HUMAN PRESCRIPTION DRUG WHITE MULBERRY POLLEN morus alba pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MORUS ALBA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-948_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-948 HUMAN PRESCRIPTION DRUG BLACK OAK POLLEN quercus velutina pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS VELUTINA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-949_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-949 HUMAN PRESCRIPTION DRUG BLACKJACK OAK POLLEN quercus nigra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS NIGRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-950_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-950 HUMAN PRESCRIPTION DRUG BUR OAK POLLEN quercus macrocarpa pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS MACROCARPA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-951_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-951 HUMAN PRESCRIPTION DRUG LIVE OAK POLLEN quercus virginiana pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS VIRGINIANA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-952_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-952 HUMAN PRESCRIPTION DRUG 2-OAK MIX, RED/WHITE POLLEN quercus rubra pollen and quercus alba pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN .5; .5 g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-953_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-953 HUMAN PRESCRIPTION DRUG 3-OAK MIX, BLACK/BLACKJACK/POST POLLEN quercus velutina pollen and quercus nigra pollen and quercus stellata pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS NIGRA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA POLLEN .33; .34; .33 g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-954_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-954 HUMAN PRESCRIPTION DRUG 5-OAK MIX, BLACKJACK/BUR/POST/RED/WHITE POLLEN quercus nigra pollen and quercus macrocarpa pollen and quercus stellata pollen and quercus rubra pollen and quercus alba pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS ALBA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS STELLATA POLLEN .2; .2; .2; .2; .2 g/20mL; g/20mL; g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-955_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-955 HUMAN PRESCRIPTION DRUG POST OAK POLLEN quercus stellata pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS STELLATA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-956_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-956 HUMAN PRESCRIPTION DRUG QUEEN PALM POLLEN syagrus romanzoffiana pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-957_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-957 HUMAN PRESCRIPTION DRUG EUROPEAN OLIVE POLLEN olea europaea pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. OLEA EUROPAEA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-958_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-958 HUMAN PRESCRIPTION DRUG OSAGE ORANGE VAR BOIS DARC POLLEN maclura pomifera pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MACLURA POMIFERA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-959_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-959 HUMAN PRESCRIPTION DRUG DATE PALM POLLEN phoenix dactylifera pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PHOENIX DACTYLIFERA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-960_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-960 HUMAN PRESCRIPTION DRUG PECAN POLLEN carya illinoinensis pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CARYA ILLINOINENSIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-962_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-962 HUMAN PRESCRIPTION DRUG WHITE PINE POLLEN pinus strobus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PINUS STROBUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-963_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-963 HUMAN PRESCRIPTION DRUG 4-PINE MIX, AUSTRIAN/LOBLOLLY/SCOTCH/WHITE POLLEN pinus strobus pollen and pinus sylvestris pollen and pinus taeda pollen and pinus nigra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PINUS NIGRA POLLEN; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN .25; .25; .25; .25 g/20mL; g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-964_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-964 HUMAN PRESCRIPTION DRUG LOMBARDY POPLAR POLLEN populus nigra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. POPULUS NIGRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-965_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-965 HUMAN PRESCRIPTION DRUG WHITE POPLAR POLLEN populus alba pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. POPULUS ALBA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-966_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-966 HUMAN PRESCRIPTION DRUG PRIVET POLLEN ligustrum vulgare pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. LIGUSTRUM VULGARE POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-967_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-967 HUMAN PRESCRIPTION DRUG BLUE SPRUCE POLLEN picea pungens pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PICEA PUNGENS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-968_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-968 HUMAN PRESCRIPTION DRUG UPLAND SUMAC POLLEN rhus glabra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. RHUS GLABRA POLLEN 1 g/20mL 54575-969_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-969 HUMAN PRESCRIPTION DRUG SYCAMORE POLLEN platanus occidentalis pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-970_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-970 HUMAN PRESCRIPTION DRUG TREE OF HEAVEN POLLEN ailanthus altissima pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-971_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-971 HUMAN PRESCRIPTION DRUG BLACK WALNUT POLLEN juglans nigra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. JUGLANS NIGRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-972_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-972 HUMAN PRESCRIPTION DRUG BLACK WILLOW POLLEN salix nigra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SALIX NIGRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-973_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-973 HUMAN PRESCRIPTION DRUG PUSSY WILLOW POLLEN salix discolor pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SALIX DISCOLOR POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-974_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-974 HUMAN PRESCRIPTION DRUG BLACK LOCUST POLLEN robinia pseudoacacia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54575-978_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-978 HUMAN PRESCRIPTION DRUG WHITE OAK POLLEN quercus alba pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS ALBA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 54576-1001_e8fe11ac-688d-4443-bcfb-df8122a8d5f4 54576-1001 HUMAN OTC DRUG Roota Re F for men PANTHENOL SHAMPOO TOPICAL 20121231 UNAPPROVED DRUG OTHER Raphabio Inc PANTHENOL 1.2 mg/240mL 54576-2001_63abf12b-aa96-4128-9098-5485a3f03532 54576-2001 HUMAN OTC DRUG Roota Re V for women PANTHENOL SHAMPOO TOPICAL 20121231 UNAPPROVED DRUG OTHER Raphabio Inc PANTHENOL 1.2 mg/240mL 54576-3001_8262bbb8-27c7-4ee5-ab48-289af41da4a0 54576-3001 HUMAN OTC DRUG Roota Re F Tonic PANTHENOL LIQUID TOPICAL 20121231 UNAPPROVED DRUG OTHER Raphabio Inc PANTHENOL .5 mg/100mL 54576-4001_85a5ce96-0229-4cff-928e-c422fbb37e0b 54576-4001 HUMAN OTC DRUG Roota Re V Tonic PANTHENOL LIQUID TOPICAL 20121231 UNAPPROVED DRUG OTHER Raphabio Inc PANTHENOL .5 mg/100mL 54582-0001_893fc550-ce3d-4146-8ac6-1c3370f9c576 54582-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19800101 UNAPPROVED MEDICAL GAS Lowry Drug Company Inc. OXYGEN 99 L/100L 54591-001_36595864-eed4-4121-acf3-4cc919708f45 54591-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19930810 UNAPPROVED MEDICAL GAS Speedy Inc. OXYGEN 99 L/100L 54593-001_7c0997fb-96ea-49bc-a5a1-7708f5d61904 54593-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140410 UNAPPROVED MEDICAL GAS CHV Home Medical Equipment Company, LLC OXYGEN 99 L/100L 54595-001_8c5fea41-6ad0-41c0-9713-188e34aacf09 54595-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19940701 UNAPPROVED MEDICAL GAS Sparrow Medical Supply L.L.C. OXYGEN 99 mL/L 54602-011_0db34654-d5f1-468f-b422-c22ccbef396f 54602-011 HUMAN OTC DRUG At One With Nature Menthol 1% GEL, DENTIFRICE TOPICAL 20140918 OTC MONOGRAPH NOT FINAL part348 BIOCARE LABS INC. MENTHOL 10 mg/g 54602-758_3398bb40-df14-494e-9e1f-619629b94979 54602-758 HUMAN OTC DRUG AT ONE WITH NATURE DRY AND ITCHY SCALP PYRITHIONE ZINC SHAMPOO TOPICAL 20090120 OTC MONOGRAPH FINAL part358H BIOCARE LABS INC. PYRITHIONE ZINC 10 mg/mL 54616-001_3dc4cafe-10de-489f-8d54-94538a3678b1 54616-001 HUMAN OTC DRUG BALANCE Bryonia, Ignatia, Nux Vom, Phos, Sepia SPRAY SUBLINGUAL 20130221 UNAPPROVED HOMEOPATHIC BDMP, LLC BRYONIA ALBA ROOT; PHOSPHORUS; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30 [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL 54619-0001_916626e8-e282-4989-b834-4ecea42604a9 54619-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20121212 UNAPPROVED MEDICAL GAS Red Ball Medical Supply OXYGEN 99 L/100L 54622-103_f2dcb695-fa13-4e1b-91e5-72ed3113a411 54622-103 HUMAN OTC DRUG enMotion High Frequency Antimicrobial Foam Handwash TRICLOSAN LOTION TOPICAL 20140116 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP TRICLOSAN 7.5 mg/mL 54622-104_04b4d287-bdaf-4a8c-90c2-485bb0841a0d 54622-104 HUMAN OTC DRUG enMotion High Frequency Foam Hand Sanitizer ALCOHOL LIQUID TOPICAL 20140116 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP ALCOHOL 62 mL/100mL 54622-389_5f3684a8-f2a0-4d16-833d-cc2a69a47b38 54622-389 HUMAN OTC DRUG enMotion Antimicrobial Healthcare Personnel Handwash Fragrance Free CHLOROXYLENOL LIQUID TOPICAL 20130821 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP CHLOROXYLENOL 10 mg/mL 54622-520_dd1a55fb-6ca5-4a33-aa1a-d84bf86655e8 54622-520 HUMAN OTC DRUG Georgia-Pacific Alcohol Hand Sanitizer Alcohol SOAP TOPICAL 20121022 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP ALCOHOL .67 mL/mL 54622-686_510c37fc-54da-4c33-a7c8-ba3eaab60015 54622-686 HUMAN OTC DRUG enMotion Hand Sanitizer with Moisturizers, Fragrance Free, Dye Free Alcohol GEL TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP ALCOHOL .5634 g/mL 54622-687_d1de5ce5-5450-468b-b9fd-bb3286250167 54622-687 HUMAN OTC DRUG Pacific Garden Antimicrobial, Fragrance Free, Dye Free Triclosan SOAP TOPICAL 20091002 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP TRICLOSAN 4.5 mg/mL 54622-688_0fe23836-fcee-4f03-adf9-14f979bdee21 54622-688 HUMAN OTC DRUG Pacific Garden Antimicrobial, Pacific Citrus, Mandarin Triclosan SOAP TOPICAL 20091002 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP TRICLOSAN 4.5 mg/mL 54622-689_861eadb7-e6cc-4978-a0ff-cd4243a895c7 54622-689 HUMAN OTC DRUG Pacific Garden Foam Hand Sanitizer, Fragrance Free, Dye Free Alcohol SOAP TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP ALCOHOL .7 mL/mL 54622-697_82671b36-d8bb-4d63-ae48-df4b2a31a7fc 54622-697 HUMAN OTC DRUG enMotion Antimicrobial with Moisturizers, Fragrance free, dye free Triclosan SOAP TOPICAL 20091002 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP TRICLOSAN 4.5 mg/mL 54622-698_c318527a-d4c3-4d2b-9afd-9586538ed508 54622-698 HUMAN OTC DRUG enMotion Antimicrobial with Moisturizers, Tranquil Aloe, Green Triclosan SOAP TOPICAL 20091002 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP TRICLOSAN 4.5 mg/mL 54622-699_29d0c494-dbfd-4ec8-ba9e-3dc85c5b616a 54622-699 HUMAN OTC DRUG enMotion Foam Hand Sanitizer w-Moisturizers, Fragrance Free Alcohol SOAP TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP ALCOHOL .7 mL/mL 54629-600_800fb383-3bb3-424a-a729-d9cd57a37a1e 54629-600 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000501 OTC MONOGRAPH NOT FINAL part334 National Vitamin Company DOCUSATE SODIUM 100 mg/1 54629-601_0c66642c-82cb-42cd-82bb-5f95852cc5d1 54629-601 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000501 OTC MONOGRAPH NOT FINAL part334 National Vitamin Company DOCUSATE SODIUM 250 mg/1 54632-001_484492a6-2cca-46ad-af4e-b0a13ccc73f2 54632-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20121115 NDA NDA206023 U.S. Oxygen and Supply, LLC OXYGEN 99 L/100L 54632-002_6d8cbe38-ad58-4d0d-9246-007452afb943 54632-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20121115 NDA NDA206024 U.S. Oxygen and Supply, LLC NITROGEN 99 L/100L 54632-003_470e5257-35dd-4b34-b705-fe1cee98ddac 54632-003 HUMAN PRESCRIPTION DRUG AIR, COMPRESSED OXYGEN GAS RESPIRATORY (INHALATION) 20121115 NDA NDA206023 U.S. Oxygen and Supply, LLC OXYGEN 21 L/100L 54632-004_25c61dad-4053-4391-a790-a3bd4c8cf119 54632-004 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 20121115 NDA NDA206025 U.S. Oxygen and Supply, LLC CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 54633-014_af575abb-90ba-4b87-b0fd-7ccb373b5c83 54633-014 HUMAN OTC DRUG Gentian Violet 2% gentian violet 2% SOLUTION TOPICAL 20141014 OTC MONOGRAPH NOT FINAL part333A The Podiatree Company GENTIAN VIOLET 2 g/100mL 54633-101_97b770e7-9125-4db8-89ee-f1b66e01a755 54633-101 HUMAN OTC DRUG Aarica Aluminum Chloride LIQUID TOPICAL 20140506 OTC MONOGRAPH FINAL part350 The Podiatree Co ALUMINUM CHLORIDE 15 g/100mL 54633-201_c0cea7f6-24bb-4efc-9e67-37835acf6b03 54633-201 HUMAN OTC DRUG K2 Cold Therapy Menthol LIQUID TOPICAL 20140506 OTC MONOGRAPH NOT FINAL part348 The Podiatree Co MENTHOL 10 g/100mL 54633-214_59fe83e0-16dc-43b3-9989-7152e4a5d5d4 54633-214 HUMAN OTC DRUG Fortinia clotrimazole 1% SOLUTION TOPICAL 20141001 OTC MONOGRAPH FINAL part333C The Podiatree Company CLOTRIMAZOLE 1 g/100mL 54633-612_43fa4b6a-20e0-4594-9474-569364282bd0 54633-612 HUMAN OTC DRUG Castellani Paint 1.5% phenol LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333A The Podiatree Company PHENOL 15 mg/mL 54633-712_4d253415-366e-4090-a971-0ebccf527d02 54633-712 HUMAN OTC DRUG Castellani Paint 1.5% phenol LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333A The Podiatree Company PHENOL 15 mg/mL 54638-0001_bc934c45-e26f-4767-8813-d3f6f08efee0 54638-0001 HUMAN OTC DRUG REHYDRATE Avena Sativa, Equisetum Hyemale, hypericum perforatum, Ulmus Fulva, Glycyrrhiza Glabra, Pueraria Lobata, Wildbad Aqua, Carlsbad Aqua LIQUID ORAL 20130807 UNAPPROVED HOMEOPATHIC ParaDocs All Natural Inc. ADENOSINE TRIPHOSPHATE; AVENA SATIVA FLOWERING TOP; EQUISETUM HYEMALE; GERMANIUM SESQUIOXIDE; GLYCYRRHIZA GLABRA; HYDROGEN; HYPERICUM PERFORATUM; OXYGEN; PUERARIA MONTANA VAR. LOBATA WHOLE; ULMUS RUBRA BARK; WATER 30; 3; 4; 30; 12; 30; 6; 30; 12; 6; 6 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 54641-001_ed9aa9c1-43e7-4f6e-9b5e-1870016124e3 54641-001 HUMAN OTC DRUG Dr Bob Arnots Pain camphor (natural), menthol PATCH TOPICAL 20121228 OTC MONOGRAPH NOT FINAL part348 Larasan Pharmaceutical Corporation CAMPHOR (NATURAL); MENTHOL 3; 2.52 g/100g; g/100g 54641-002_c4238445-ad51-400e-bfb4-4029adb7dd15 54641-002 HUMAN OTC DRUG Dr Bob Arnots Pain Pen Camphor (Natural) LIQUID TOPICAL 20130108 OTC MONOGRAPH NOT FINAL part348 Larasan Pharmaceutical Corporation CAMPHOR (NATURAL) 7.79 g/100mL 54641-004_634cdaa7-f371-4117-a024-f109ffda7bc7 54641-004 HUMAN OTC DRUG Flex24 Performance Pen camphor LIQUID TOPICAL 20140408 OTC MONOGRAPH NOT FINAL part348 Larasan Pharmaceutical Corporation CAMPHOR (NATURAL) 7.79 g/100mL 54641-005_9cf5857a-71cf-48fe-ae48-efdf959d291f 54641-005 HUMAN OTC DRUG Flex24 Pain Camphor Menthol PATCH TOPICAL 20140912 OTC MONOGRAPH NOT FINAL part348 Larasan Pharmaceutical Corporation CAMPHOR (NATURAL); MENTHOL 3; 2.52 g/100g; g/100g 54641-006_bf79e636-29bd-4642-b7be-17cdb4412215 54641-006 HUMAN OTC DRUG Flex24 Performance Camphor, Menthol PATCH TOPICAL 20140408 OTC MONOGRAPH NOT FINAL part348 Larasan Pharmaceutical Corporation CAMPHOR (NATURAL); MENTHOL 3; 2.52 g/100g; g/100g 54643-5646_2e3c2e71-a3b8-48bf-8e95-96299424cad5 54643-5646 HUMAN PRESCRIPTION DRUG Pediatric Infuvite Multiple Vitamins for Infusion Asorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin 5-phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Fo INJECTION, SOLUTION INTRAVENOUS 20010221 NDA NDA021265 Sandoz Canada Inc ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE 7; 80; 20; 400; 1; 5; 140; 17; .2; 1; 1.4; 1.2; 2300 [iU]/5mL; mg/5mL; ug/5mL; [iU]/5mL; ug/5mL; mg/5mL; ug/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; [iU]/5mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 54643-5647_474b0f3d-0928-48a2-99eb-fd121f20b2c6 54643-5647 HUMAN PRESCRIPTION DRUG Pediatric Infuvite Multiple Vitamins Asorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin KIT 20040129 NDA NDA021646 Sandoz Canada Inc 54643-5649_59754e70-d6d1-4738-8ba7-b8e2bc959dcf 54643-5649 HUMAN PRESCRIPTION DRUG Adult Infuvite Multiple Vitamins for Infusion Asorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin 5-phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Fo INJECTION, SOLUTION INTRAVENOUS 20050518 NDA NDA021163 Sandoz Canada Inc ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE 10; 200; 60; 200; 5; 15; 600; 40; 150; 6; 3.6; 6; 3300 [iU]/10mL; mg/10mL; ug/10mL; [iU]/10mL; ug/10mL; mg/10mL; ug/10mL; mg/10mL; ug/10mL; mg/10mL; mg/10mL; mg/10mL; [iU]/10mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 54643-5650_1525da91-84d5-457b-beaa-4f8b3303d8c5 54643-5650 HUMAN PRESCRIPTION DRUG Adult Infuvite Multiple Vitamins for Infusion Pharmacy Bulk Asorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin 5-phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin INJECTION, SOLUTION INTRAVENOUS 20030616 NDA NDA021559 Sandoz Canada Inc .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE 10; 200; 60; 200; 5; 15; 600; 40; 150; 6; 3.6; 6; 3300 [iU]/10mL; mg/10mL; ug/10mL; [iU]/10mL; ug/10mL; mg/10mL; ug/10mL; mg/10mL; ug/10mL; mg/10mL; mg/10mL; mg/10mL; [iU]/10mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 54679-0001_381f221b-b9e6-42c6-9e4d-7943176958ac 54679-0001 HUMAN OTC DRUG Antimicrobial Hand Lotion Soap 652 HAND SANITIZER LOTION TOPICAL 19940101 OTC MONOGRAPH FINAL part333 Montgomery County Chapter Nysarc, Inc dba Liberty Enterprises CHLOROXYLENOL 3.6 mL/800mL 54679-6657_2ba46c25-07b2-493a-8b9d-a221648496a5 54679-6657 HUMAN OTC DRUG INSTANT HAND SANITIZER HAND SANITIZER GEL TOPICAL 19980101 OTC MONOGRAPH FINAL part333 Montgomery County Chapter Nysarc, Inc dba Liberty Enterprises ALCOHOL 62 mL/100mL 54705-160_8662a07c-ad6b-48ef-9832-107ce2bd07e6 54705-160 HUMAN OTC DRUG FluNada Cold and Flu Relief EUCALYPTOL, EUCALYPTUS GLOBULUS WHOLE, MENTHOL, SAMBUCUS NIGRA WHOLE, METHYL SALICYLATE SPRAY, METERED NASAL; ORAL 20121218 UNAPPROVED HOMEOPATHIC Flutrends International Corporation EUCALYPTOL; EUCALYPTUS GLOBULUS WHOLE; MENTHOL; METHYL SALICYLATE; SAMBUCUS NIGRA WHOLE 3; 3; 4; 3; 2 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL 54706-0001_4446b3c0-6019-44d5-8bb2-583518641f4f 54706-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100112 UNAPPROVED MEDICAL GAS Garrett County Memorial Hospital OXYGEN 99 L/100L 54723-100_e1089155-98d6-4171-bac3-0d25b49b8a35 54723-100 HUMAN OTC DRUG Predator LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 40 mg/g 54723-101_2a1793fd-ffbe-4170-8cb0-32ec9485635b 54723-101 HUMAN OTC DRUG Predator Lidocaine Hydrochloride CREAM TOPICAL 20130211 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 400 mg/mg 54723-150_11d17149-b258-462f-971e-cb481a2a7e91 54723-150 HUMAN OTC DRUG Predator Lidocaine HCL CREAM TOPICAL 20130211 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 400 mg/mg 54723-175_bbe83b62-8f8f-4bee-9d90-d93fa2fac110 54723-175 HUMAN OTC DRUG NeuroMed 7 Topical Pain Relief LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 4 g/100g 54726-0100_811451ab-cc59-4c42-bf01-3b80926f58a2 54726-0100 HUMAN OTC DRUG St. Ives Blemish and Blackhead control Salicylic Acid EMULSION TOPICAL 20110223 OTC MONOGRAPH FINAL part333D Cosmetic Laboratories of America SALICYLIC ACID .02 g/g 54726-0200_4b7b7c06-17b0-4caf-a4f8-383ed4a8bff4 54726-0200 HUMAN OTC DRUG St. Ives Blemish and Blackhead Facial Wash Salicylic Acid SOAP TOPICAL 20110228 OTC MONOGRAPH FINAL part333D Cosmetic Laboratories of America SALICYLIC ACID .02 g/mL 54726-0500_e3ac1218-97ee-42d9-b030-7d3e266eb28f 54726-0500 HUMAN OTC DRUG ST. IVES BODY SCRUB NATURALLY CLEAR SKIN GREEN TEA Salicylic Acid EMULSION TOPICAL 20110214 OTC MONOGRAPH FINAL part333D Cosmetic Laboratories of America SALICYLIC ACID .02 mL/mL 54726-0600_067229ed-f1fb-4506-9e18-94499b15630e 54726-0600 HUMAN OTC DRUG ST. IVES BODY WASH NATURALLY CLEAR SKIN GREEN TEA Salicylic Acid SOAP TOPICAL 20110214 OTC MONOGRAPH FINAL part333D Cosmetic Laboratories of America SALICYLIC ACID .02 mL/mL 54726-2000_776c244d-d5c0-427f-bc9c-32e43af267df 54726-2000 HUMAN OTC DRUG Simple Vital Vitamin Day SPF 15 Homosalate, Octisalate, Avobenzone, and Octocrylene EMULSION TOPICAL 20120101 OTC MONOGRAPH FINAL part352 Cosmetic Laboratories of America AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .03; .12; .05; .027 g/g; g/g; g/g; g/g 54738-115_215d1ac5-309f-4bb5-a37d-0546b9913d35 54738-115 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20000215 OTC MONOGRAPH FINAL part341 Richmond Pharmaceuticals Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 54738-116_215d1ac5-309f-4bb5-a37d-0546b9913d35 54738-116 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20000215 OTC MONOGRAPH FINAL part341 Richmond Pharmaceuticals Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 54738-554_0a17f470-45f5-4d52-b445-93ef52195650 54738-554 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 19981224 ANDA ANDA040254 Richmond Pharmaceuticals, Inc. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 54738-555_0a17f470-45f5-4d52-b445-93ef52195650 54738-555 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 19981224 ANDA ANDA040254 Richmond Pharmaceuticals, Inc. TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 54738-901_acf1a1cf-5afa-45ed-b002-5f5905f83cd8 54738-901 HUMAN PRESCRIPTION DRUG Quinidine Gluconate Quinidine Gluconate TABLET, EXTENDED RELEASE ORAL 19870210 ANDA ANDA089338 Richmond Pharmaceuticals, Inc. QUINIDINE GLUCONATE 324 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] 54738-902_034a7f71-4589-441c-b585-d57be8942b80 54738-902 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20090904 ANDA ANDA072050 Richmond Pharmaceuticals SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54738-903_034a7f71-4589-441c-b585-d57be8942b80 54738-903 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20090904 ANDA ANDA072051 Richmond Pharmaceuticals SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54738-904_d9b990e5-6bd6-4ad3-b017-5bbf8ee8b56f 54738-904 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 ANDA ANDA075896 Richmond Pharmaceuticals, Inc. FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54738-905_d9b990e5-6bd6-4ad3-b017-5bbf8ee8b56f 54738-905 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 ANDA ANDA075896 Richmond Pharmaceuticals, Inc. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54738-906_d9b990e5-6bd6-4ad3-b017-5bbf8ee8b56f 54738-906 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 ANDA ANDA075896 Richmond Pharmaceuticals, Inc. FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54738-907_eb6c8ff1-1c68-444a-b72e-c97b63698ea7 54738-907 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 Richmond Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54738-908_eb6c8ff1-1c68-444a-b72e-c97b63698ea7 54738-908 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19870904 ANDA ANDA070924 Richmond Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54738-909_eb6c8ff1-1c68-444a-b72e-c97b63698ea7 54738-909 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19870904 ANDA ANDA070923 Richmond Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54738-912_4a5bbf60-09b2-41e4-afd0-20bfc7c0d7e2 54738-912 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19900605 ANDA ANDA081048 Richmond Pharmaceuticals, Inc. IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 54738-913_4a5bbf60-09b2-41e4-afd0-20bfc7c0d7e2 54738-913 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19900605 ANDA ANDA081049 Richmond Pharmaceuticals, Inc. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 54738-914_4a5bbf60-09b2-41e4-afd0-20bfc7c0d7e2 54738-914 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19900605 ANDA ANDA081050 Richmond Pharmaceuticals, Inc. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 54738-950_5124e848-6b21-4954-86ba-cce099a8f359 54738-950 HUMAN PRESCRIPTION DRUG ribavirin ribavirin TABLET, FILM COATED ORAL 20080601 ANDA ANDA077456 Richmond Pharmaceuticals, Inc. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 54738-951_5124e848-6b21-4954-86ba-cce099a8f359 54738-951 HUMAN PRESCRIPTION DRUG ribavirin ribavirin TABLET, FILM COATED ORAL 20080601 ANDA ANDA077456 Richmond Pharmaceuticals, Inc. RIBAVIRIN 400 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 54738-952_5124e848-6b21-4954-86ba-cce099a8f359 54738-952 HUMAN PRESCRIPTION DRUG ribavirin ribavirin TABLET, FILM COATED ORAL 20080601 ANDA ANDA077456 Richmond Pharmaceuticals, Inc. RIBAVIRIN 600 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 54738-953_e21bf417-f3ba-47ec-bb40-37a12ac1b527 54738-953 HUMAN PRESCRIPTION DRUG ribavirin ribavirin CAPSULE ORAL 20071101 ANDA ANDA076203 Richmond Pharmaceuticals, Inc. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 54738-963_39803ffc-abf0-4bfb-a5db-9612d2116f1f 54738-963 HUMAN OTC DRUG Ferrous Sulfate Ferrous Sulfate TABLET ORAL 20081105 UNAPPROVED DRUG OTHER Richmond Pharmaceuticals Inc. FERROUS SULFATE 325 mg/1 54748-101_13b09ae8-9eb0-40d9-8dde-fcc2ed7d32e1 54748-101 HUMAN OTC DRUG EO HAND SANITIZER Lavender alcohol SPRAY TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL 54748-102_8f2a40b7-0e76-449e-887e-c15cbcd49ed1 54748-102 HUMAN OTC DRUG EO HAND SANITIZER Peppermint alcohol SPRAY TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL 54748-103_77bf0900-9226-4264-b02a-09f573bef6d6 54748-103 HUMAN OTC DRUG EO HAND SANITIZER Sweet Orange alcohol SPRAY TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL 54748-201_463c312a-3d20-47e5-94cf-dfe40b027762 54748-201 HUMAN OTC DRUG EO HAND SANITIZER Lavender alcohol GEL TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL 54748-202_9c976076-4b3f-4f4f-b5b3-5ea99bf78549 54748-202 HUMAN OTC DRUG EO HAND SANITIZER Lemon alcohol GEL TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL 54748-203_a11323bb-64ef-425f-a67f-b3755b743438 54748-203 HUMAN OTC DRUG EO HAND SANITIZER Unscented alcohol GEL TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL 54748-301_79cb9209-412a-414d-b4a3-21dd88824e55 54748-301 HUMAN OTC DRUG everyone Hand Sanitizer Coconut Lemon alcohol SPRAY TOPICAL 20130607 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL 54748-302_a162ae0b-5ee1-4534-bec5-d5a3e00aa9d0 54748-302 HUMAN OTC DRUG everyone Hand Sanitizer Peppermint Citrus alcohol SPRAY TOPICAL 20130607 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL 54748-401_7bd28c14-2180-4618-950b-eeafd948569e 54748-401 HUMAN OTC DRUG everyone Hand Sanitizer Coconut Lemon alcohol GEL TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL 54748-401_a04e77e0-5ddd-4039-940c-0046e570a52b 54748-401 HUMAN OTC DRUG everyone Hand Sanitizer Coconut Lemon alcohol GEL TOPICAL 20130607 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL 54748-402_5fd2ef82-2210-4b90-b248-b44acbaf0daf 54748-402 HUMAN OTC DRUG everyone Hand Sanitizer Peppermint Citrus alcohol GEL TOPICAL 20130607 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL 54753-001_422a8663-ef4a-45ea-a8ae-ad8ca71d3f72 54753-001 HUMAN OTC DRUG Athomer Sodium Chloride SPRAY NASAL 20130114 OTC MONOGRAPH FINAL part349 PHARMACOSMETIC-DIAFARM SODIUM CHLORIDE .9 g/100mL 54753-002_43ceee78-d717-4115-aeca-fcd8ed68d355 54753-002 HUMAN OTC DRUG Athomer mini Sodium Chloride SPRAY NASAL 20130114 OTC MONOGRAPH FINAL part349 PHARMACOSMETIC-DIAFARM SODIUM CHLORIDE .9 g/100mL 54753-003_46fa8d8e-7a0c-4498-8a95-22823f452f82 54753-003 HUMAN OTC DRUG Athomer baby Sodium Chloride SPRAY NASAL 20130114 OTC MONOGRAPH FINAL part349 PHARMACOSMETIC-DIAFARM SODIUM CHLORIDE .9 g/100mL 54754-101_d6393e4f-fd08-460e-9398-f09026983b33 54754-101 HUMAN OTC DRUG TREAT AND TINT SKIN PERFECTING BB SPF 30 OCTINOXATE OCTISALATE AVOBENZONE CREAM TOPICAL 20130106 OTC MONOGRAPH FINAL part352 SORME COMPANY INC AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 6; 4.5 g/100mL; g/100mL; g/100mL 54766-726_63606800-4fa8-11e4-916c-0800200c9a66 54766-726 HUMAN PRESCRIPTION DRUG Pramosone hydrocortisone acetate and pramoxine hydrochloride LOTION TOPICAL 19770730 ANDA ANDA085979 Sebela Pharmaceuticals Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 25; 10 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54767-001_40799c61-77a3-43c8-8c78-fb3a374dcd68 54767-001 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 20100914 UNAPPROVED MEDICAL GAS Shaw Oxygen Company, Inc. OXYGEN 995 mL/L 54776-001_a034ea4d-bf91-4300-87ed-0f685c7cea53 54776-001 HUMAN PRESCRIPTION DRUG Heliox Heliox GAS RESPIRATORY (INHALATION) 20130101 UNAPPROVED MEDICAL GAS Spec Connection International Inc HELIUM; OXYGEN 700; 300 mL/L; mL/L 54776-002_4619d090-d857-48e3-94aa-8bb2478e43d0 54776-002 HUMAN PRESCRIPTION DRUG Hyperbaric Chamber Mix Hyperbaric Chamber Mix GAS RESPIRATORY (INHALATION) 20130101 UNAPPROVED MEDICAL GAS Spec Connection International Inc NITROGEN; OXYGEN 500; 500 mL/L; mL/L 54776-003_a58e5661-0d2e-4522-9caa-481bd8c1018d 54776-003 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mixture Carbon Dioxide Oxygen Mixture GAS RESPIRATORY (INHALATION) 20130101 UNAPPROVED MEDICAL GAS Spec Connection International Inc CARBON DIOXIDE; OXYGEN 200; 800 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 54799-432_fa599beb-f035-e429-12b9-99c405057c55 54799-432 HUMAN PRESCRIPTION DRUG HOMATROPINE HYDROBROMIDE HOMATROPINE HYDROBROMIDE OPHTHALMIC SOLUTION OPHTHALMIC 20140210 UNAPPROVED DRUG OTHER OCuSOFT, Inc. HOMATROPINE HYDROBROMIDE 50 mg/mL Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 54799-503_7cbe515b-88df-8f21-88e9-6be068b04565 54799-503 HUMAN OTC DRUG GONIOSOFT Hypromellose 2.5% LIQUID OPHTHALMIC 19891002 UNAPPROVED DRUG OTHER OCuSOFT, Inc. HYPROMELLOSES 25 mg/mL 54799-504_2e0fd72a-c45e-473f-9419-c09d0cd74f89 54799-504 HUMAN PRESCRIPTION DRUG TetraVisc Forte Tetracaine Hydrochloride LIQUID OPHTHALMIC 20090825 UNAPPROVED DRUG OTHER OCuSOFT, INC. TETRACAINE HYDROCHLORIDE 25 mg/5mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 54799-504_a94b8262-590b-4164-b2cb-e0b074888d1b 54799-504 HUMAN PRESCRIPTION DRUG TetraVisc Forte Tetracaine Hydrochloride LIQUID OPHTHALMIC 20090825 UNAPPROVED DRUG OTHER OCuSOFT, INC. TETRACAINE HYDROCHLORIDE 3 mg/.6mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 54799-505_12cb00e5-6494-4bfe-afa3-9cf5cf6c2211 54799-505 HUMAN PRESCRIPTION DRUG TetraVisc Tetracaine Hydrochloride LIQUID OPHTHALMIC 20050802 UNAPPROVED DRUG OTHER OCuSOFT, Inc. TETRACAINE HYDROCHLORIDE 25 mg/5mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 54799-507_7f07fd14-e89d-414b-8223-2cfb6eb9d6ba 54799-507 HUMAN PRESCRIPTION DRUG FLUCAINE Fluorescein Sodium and Proparacaine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19890330 UNAPPROVED DRUG OTHER OCuSOFT, Inc. FLUORESCEIN SODIUM; PROPARACAINE HYDROCHLORIDE 2.5; 5 mg/mL; mg/mL Diagnostic Dye [EPC],Dyes [MoA],Local Anesthesia [PE],Local Anesthetic [EPC] 54799-508_5476a07b-4f5c-3b6b-38b3-b006435306c1 54799-508 HUMAN PRESCRIPTION DRUG Flurox Fluorescein Sodium 2.5mg (0.25%), Benoxinate Hydrochloride 4mg (0.4%) SOLUTION OPHTHALMIC 20140129 UNAPPROVED DRUG OTHER OCuSOFT, Inc. BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM 4; 2.5 mg/mL; mg/mL Diagnostic Dye [EPC],Dyes [MoA] 54799-533_e443a044-dbb9-48b8-a4da-cfad0781509c 54799-533 HUMAN PRESCRIPTION DRUG Alodox Doxycyline Hyclate TABLET ORAL 20081001 ANDA ANDA065277 OCuSOFT INC. DOXYCYCLINE HYCLATE 20 mg/1 54799-535_7a80af0f-b54d-4a1f-864c-7ecda14c777b 54799-535 HUMAN PRESCRIPTION DRUG Ocudox Doxycycline Hyclate CAPSULE ORAL 20110401 ANDA ANDA062675 OCuSOFT INC. DOXYCYCLINE HYCLATE 50 mg/1 54799-565_e78cfa7e-d686-086d-8447-53d434aa5ce9 54799-565 HUMAN OTC DRUG PURIFIED WATER PURIFIED WATER SOLUTION/ DROPS OPHTHALMIC 20090101 OTC MONOGRAPH FINAL part349 OCuSOFT, Inc. WATER 99.03 mL/100mL 54799-893_5c45fe80-ee62-6342-6345-4ada7825ebaa 54799-893 HUMAN OTC DRUG retaine PM Mineral Oil, White petrolatum OINTMENT OPHTHALMIC 20130902 OTC MONOGRAPH FINAL part347 OCuSOFT, Inc. MINERAL OIL; PETROLATUM 200; 800 mg/g; mg/g 54799-896_620ca1fc-c10a-3933-3340-36aaedd7c566 54799-896 HUMAN OTC DRUG retaine HPMC Hypromellose 2910 (4000 Mpa.s) SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20130501 OTC MONOGRAPH FINAL part349 OCuSOFT, Inc. HYPROMELLOSE 2910 (4000 MPA.S) 3 mg/mL 54799-897_ac103906-7e9b-4582-9159-34a2cca56dad 54799-897 HUMAN OTC DRUG Retaine CMC Lubricant Eye Drops Carboxymethylcellulose Sodium SOLUTION OPHTHALMIC 20110901 OTC MONOGRAPH FINAL part349 OCuSOFT Inc. CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL 54799-906_39887c74-277e-dc11-d9c9-90789f65c53d 54799-906 HUMAN OTC DRUG Tears Again opht Mineral oil, White petrolatum OINTMENT OPHTHALMIC 20130901 OTC MONOGRAPH FINAL part347 OCuSOFT, Inc. MINERAL OIL; PETROLATUM 200; 800 mg/g; mg/g 54799-917_e2ef5df3-6479-47c5-be0a-bb76c090a57a 54799-917 HUMAN OTC DRUG retaine MGD Mineral Oil EMULSION OPHTHALMIC 20120105 OTC MONOGRAPH FINAL part349 OCuSOFT, Inc. LIGHT MINERAL OIL; MINERAL OIL .002; .002 mL/.4mL; mL/.4mL 54799-925_2fba3378-b917-2733-9088-df73a0e63ae9 54799-925 HUMAN OTC DRUG Sochlor Sodium Chloride Hypertonicity Ophthalmic Solution 5% Solution SOLUTION/ DROPS OPHTHALMIC 20140203 OTC MONOGRAPH FINAL part349 OCuSOFT, Inc. SODIUM CHLORIDE 50 mg/mL 54799-926_20729204-3c2e-ba74-1244-b1832e30abfd 54799-926 HUMAN OTC DRUG Sochlor Sodium Chloride Hypertonicity Ophthalmic Ointment 5% Sterile OINTMENT OPHTHALMIC 20140205 OTC MONOGRAPH FINAL part349 OCuSOFT, Inc. SODIUM CHLORIDE 50 mg/g 54828-001_554ecc19-bacc-48a1-a490-efbd69daa3cd 54828-001 HUMAN PRESCRIPTION DRUG Neuraceq florbetaben F 18 INJECTION, SOLUTION INTRAVENOUS 20140320 NDA NDA204677 Piramal Imaging, SA FLORBETABEN F-18 135 mCi/mL Radioactive Diagnostic Agent [EPC],Positron Emitting Activity [MoA] 54829-001_8cc4150d-92c9-4382-8119-9f5755770145 54829-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20121001 UNAPPROVED MEDICAL GAS Central Oxygen Inc OXYGEN 99 L/100L 54832-0001_ed9af751-0796-4f29-8959-268684b916cf 54832-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850815 UNAPPROVED MEDICAL GAS Heart of the Ozarks Medical Equipment OXYGEN 99 L/100L 54838-101_838948cd-763a-42f1-8bb7-48e95a31d297 54838-101 HUMAN OTC DRUG Silafed Pseudoephedrine hydrochloride and Triprolidine hydrochloride SYRUP ORAL 19881005 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 30; 1.25 mg/5mL; mg/5mL 54838-104_c7da7339-b0ae-4142-8973-84661ab4ccd2 54838-104 HUMAN OTC DRUG Childrens Silfedrine Pseudoephedrine hydrochloride LIQUID ORAL 20010105 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg/5mL 54838-105_9331ca3a-5e93-4897-a855-8fa0c07f41bf 54838-105 HUMAN OTC DRUG Silphen DM Cough Dextromethorphan Hydrobromide LIQUID ORAL 19871201 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL 54838-107_f422390a-1793-4e38-a43b-1163205f2a47 54838-107 HUMAN OTC DRUG Silace Docusate sodium SYRUP ORAL 19900305 OTC MONOGRAPH NOT FINAL part334 Silarx Pharmaceuticals,Inc DOCUSATE SODIUM 60 mg/15mL 54838-115_872f592b-cfb7-4e5d-9cc9-b625da8a22f4 54838-115 HUMAN OTC DRUG Pediatric Cough and Cold Medicine Chlorpheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide LIQUID ORAL 19970105 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 5; 15 mg/5mL; mg/5mL; mg/5mL 54838-116_a17022ea-3918-485f-a68c-1c5549a9bb52 54838-116 HUMAN OTC DRUG Silace Docusate sodium LIQUID ORAL 19901005 OTC MONOGRAPH NOT FINAL part334 Silarx Pharmaceuticals, Inc DOCUSATE SODIUM 10 mg/mL 54838-117_65e995d0-c415-4e7f-a6c5-6f567899f684 54838-117 HUMAN OTC DRUG Siltussin SA Guaifenesin LIQUID ORAL 19981005 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc GUAIFENESIN 100 mg/5mL 54838-125_8408e1b1-ee76-4119-b4d1-cc2d50585121 54838-125 HUMAN OTC DRUG Brotapp Brompheniramine maleate and Pseudoephedrine hydrochloride LIQUID ORAL 20010405 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 15 mg/5mL; mg/5mL 54838-130_effcd03b-b2fa-408a-9495-3b06eba94154 54838-130 HUMAN OTC DRUG Siltussin DAS Guaifenesin LIQUID ORAL 19960201 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc GUAIFENESIN 100 mg/5mL 54838-133_0b76921b-7f8b-432f-81ce-fd2f62556424 54838-133 HUMAN OTC DRUG Siltussin DM DAS Cough Formula Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 19950905 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 54838-135_d4b8cc0b-dfe3-4ee2-ae21-80a19eacc997 54838-135 HUMAN OTC DRUG Siladryl Allergy Medicine diphenhydramine hydrochloride LIQUID ORAL 19970101 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 54838-136_88e8500e-847d-4f90-a89d-432d0d342e91 54838-136 HUMAN OTC DRUG Brotapp DM Cold and Cough Brompheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide LIQUID ORAL 20010405 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 5; 15 mg/5mL; mg/5mL; mg/5mL 54838-138_b98adb86-afb9-4e95-a8a2-3a5bbb8afadb 54838-138 HUMAN OTC DRUG Diabetic Siltussin DAS-Na Guaifenesin LIQUID ORAL 20051205 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc GUAIFENESIN 100 mg/5mL 54838-139_a3ff6462-14a9-4094-b8c6-def9eef034fd 54838-139 HUMAN OTC DRUG Diabetic Siltussin DM DAS-Na Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 20051105 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 54838-140_584711d9-fce3-4088-a1f6-f6bf64b8f156 54838-140 HUMAN OTC DRUG Diabetic Maximum Strength Siltussin DM DAS-Na Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 20051105 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/5mL; mg/5mL 54838-144_b8694264-a585-4994-83ec-594f2f5d1fab 54838-144 HUMAN OTC DRUG Childrens Silapap Acetaminophen LIQUID ORAL 19940905 OTC MONOGRAPH NOT FINAL part343 Silarx Pharmaceuticals, Inc ACETAMINOPHEN 160 mg/5mL 54838-145_b6145102-e475-48cd-8809-8115a35f2a78 54838-145 HUMAN OTC DRUG Infants Silapap Acetaminophen SOLUTION/ DROPS ORAL 19970401 OTC MONOGRAPH NOT FINAL part343 Silarx Pharmaceuticals, Inc ACETAMINOPHEN 80 mg/.8mL 54838-147_120836b1-4eb3-4523-8221-a38296cee866 54838-147 HUMAN OTC DRUG Brotapp PE-DM Cough and Cold Liquid Brotapp PE-DM Cough and Cold Liquid LIQUID ORAL 20010402 OTC MONOGRAPH FINAL part341 Silarx Pharmaceutical, Inc BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 54838-154_32730640-56e1-4c59-8058-c2ef8ed64e61 54838-154 HUMAN OTC DRUG Silphen Diphenhydramine hydrochloride SYRUP ORAL 19931203 OTC MONOGRAPH FINAL part341 Silarx Pharmaceutical, Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 54838-209_0acdbd81-2461-4fe0-99fb-72727a8e83a4 54838-209 HUMAN OTC DRUG Siltussin DM Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 19920905 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals,Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 54838-501_472d3fa1-51c0-46e4-bb09-910145f9c438 54838-501 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol SOLUTION ORAL 20090908 ANDA ANDA073364 Silarx Pharmaceuticals, Inc HALOPERIDOL LACTATE 2 mg/mL Typical Antipsychotic [EPC] 54838-502_6c9554f9-8208-4627-9ec0-65a753302747 54838-502 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine Hydrochloride SOLUTION ORAL 20130821 ANDA ANDA201674 Silarx Pharmaceuticals, Inc HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 54838-506_82d9f048-acc5-4149-b4db-3a2c35c7e5ce 54838-506 HUMAN PRESCRIPTION DRUG Hyosyne Hyoscyamine Sulfate SOLUTION/ DROPS ORAL 19971001 UNAPPROVED DRUG OTHER Silarx Pharmaceuticals, Inc HYOSCYAMINE SULFATE .125 mg/mL 54838-507_1feaf834-ccfd-4283-9445-d05c777461ef 54838-507 HUMAN PRESCRIPTION DRUG Metaproterenol Sulfate Metaproterenol Sulfate SYRUP ORAL 20090908 ANDA ANDA073632 Silarx Pharmaceuticals, Inc METAPROTERENOL SULFATE 10 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 54838-510_a678cac0-b604-4084-872d-299ab419bc67 54838-510 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride SYRUP ORAL 20090908 ANDA ANDA074520 Silarx Pharmaceuticals, Inc OXYBUTYNIN CHLORIDE 5 mg/5mL Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54838-511_7c2a13da-2ebf-4501-b999-ab51b817df3f 54838-511 HUMAN PRESCRIPTION DRUG Hyosyne Hyoscyamine Sulfate ELIXIR ORAL 19971101 UNAPPROVED DRUG OTHER Silarx Pharmaceuticals, Inc HYOSCYAMINE SULFATE .125 mg/5mL 54838-512_5eb348ae-d8ed-423e-a126-ac99629c69ee 54838-512 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride SOLUTION ORAL 19981229 ANDA ANDA074721 Silarx Pharmaceuticals, Inc DOXEPIN HYDROCHLORIDE 10 mg/mL Tricyclic Antidepressant [EPC] 54838-514_cf38b2c2-9171-49e8-9fd1-1f81967c0428 54838-514 HUMAN PRESCRIPTION DRUG Clemastine Fumarate Clemastine Fumarate SYRUP ORAL 19971217 ANDA ANDA074884 Silarx Pharmaceuticals, Inc CLEMASTINE FUMARATE .5 mg/mL 54838-522_53e33cd6-d13b-45fe-b427-57e3218a24d7 54838-522 HUMAN PRESCRIPTION DRUG CHOLINE MAGNESIUM TRISALICYLATE CHOLINE MAGNESIUM TRISALICYLATE LIQUID ORAL 19970205 UNAPPROVED DRUG OTHER Silarx Pharmaceuticals, Inc CHOLINE MAGNESIUM TRISALICYLATE 500 mg/5mL 54838-523_ed3c84c4-7dc6-4414-9b94-c5d562dae881 54838-523 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride LIQUID ORAL 20090827 ANDA ANDA077849 Silarx Pharmaceuticals, Inc FLUOXETINE HYDROCHLORIDE 20 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54838-540_a89d964d-d50e-4239-8067-da4b5b70a2cb 54838-540 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide SOLUTION ORAL 20060614 ANDA ANDA077629 Silarx Pharmaceuticals, Inc CITALOPRAM HYDROBROMIDE 10 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54838-548_6514e704-9de8-45ee-8820-e1e32834a94a 54838-548 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090403 ANDA ANDA090263 Silarx Pharmaceuticals, Inc LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54838-550_cc7dd835-7620-40bd-8415-7c4b738e96c5 54838-550 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine Hydrochloride SOLUTION ORAL 20101210 ANDA ANDA091288 Silarx Pharmaceuticals, Inc RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 54838-551_f584f9d7-c9c7-4a63-a042-ab598c6cc784 54838-551 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate SOLUTION ORAL 20130612 ANDA ANDA090477 Silarx Pharmaceuticals, Inc ESCITALOPRAM OXALATE 5 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54838-552_cfe92867-6aed-4e8c-bd72-6693c5d05682 54838-552 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20110502 ANDA ANDA091130 Silarx Pharmaceuticals, Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 54838-554_7bf43d1e-5a72-4401-b8e2-8da4c5a15a0d 54838-554 HUMAN OTC DRUG Loratadine Loratadine SOLUTION ORAL 20101124 ANDA ANDA077421 Silarx Pharmaceuticals, Inc LORATADINE 5 mg/5mL 54838-555_a92a0bef-da9d-4be5-9d27-a666dff75e89 54838-555 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride SOLUTION ORAL 20110127 ANDA ANDA091342 Silarx Pharmaceuticals, Inc ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 54838-556_bbe04fbf-42f6-49d2-9b7f-ee140a71e4c3 54838-556 HUMAN PRESCRIPTION DRUG Theophylline Theophylline SOLUTION ORAL 20110413 ANDA ANDA091156 Silarx Pharmaceuticals, Inc THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 54838-558_7bf43d1e-5a72-4401-b8e2-8da4c5a15a0d 54838-558 HUMAN OTC DRUG Loratadine Loratadine SOLUTION ORAL 20101124 ANDA ANDA077421 Silarx Pharmaceuticals, Inc LORATADINE 5 mg/5mL 54838-559_cfe92867-6aed-4e8c-bd72-6693c5d05682 54838-559 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20110506 ANDA ANDA091130 Silarx Pharmaceuticals, Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 54838-566_45c58df6-66fc-4c39-a7b7-f18e49daa35e 54838-566 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine SOLUTION ORAL 20140130 ANDA ANDA203564 Silarx Pharmaceuticals, Inc LAMIVUDINE 10 mg/mL Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 54838-571_4c5c4281-3e25-426f-8711-ee71c0e3468b 54838-571 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SYRUP ORAL 20120511 ANDA ANDA078876 Silarx Pharmaceuitcals, Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 54838-572_4c5c4281-3e25-426f-8711-ee71c0e3468b 54838-572 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SYRUP ORAL 20120511 ANDA ANDA078876 Silarx Pharmaceuitcals, Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 54841-001_67755d0f-9e46-4d57-b631-18b587bc2846 54841-001 HUMAN OTC DRUG Photocil Dimethicone CREAM TOPICAL 20140301 OTC MONOGRAPH FINAL part347 Applied Biology DIMETHICONE .07 g/7g 54841-001_7807ce1f-742e-4b37-91f3-910c8d847ae8 54841-001 HUMAN OTC DRUG Photocil Dimethicone CREAM TOPICAL 20140301 OTC MONOGRAPH FINAL part347 Applied Biology DIMETHICONE .6 g/60g 54841-001_7f20dc95-4ac5-4c21-8187-f8fe47f6fe66 54841-001 HUMAN OTC DRUG Photocil Dimethicone CREAM TOPICAL 20140301 OTC MONOGRAPH FINAL part347 Applied Biology DIMETHICONE .6 g/60g 54859-110_a19a62af-3dd9-4081-9d47-f72dcda27378 54859-110 HUMAN OTC DRUG Dologesic DF Acetaminophen, Phenyltoloxamine Citrate TABLET ORAL 20090901 OTC MONOGRAPH NOT FINAL part343 LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION ACETAMINOPHEN; PHENYLTOLOXAMINE CITRATE 500; 30 mg/1; mg/1 54859-120_7a7884d7-7b51-4101-ac96-d61c47346a59 54859-120 HUMAN OTC DRUG Dermagesic Pramoxine HCl, Zinc Oxide, Calamine LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part347 Llorens Pharmaceuticals International Division FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE .4; 1; .4 mg/100mL; mg/100mL; mg/100mL 54859-502_df79e34b-03b2-4813-8435-486c6d71cf64 54859-502 HUMAN OTC DRUG Tusnel Dextromethorphan, Guiafenesin, Pseudoephedrine HCl LIQUID ORAL 20060101 OTC MONOGRAPH FINAL part341 Llorens Pharmaceutical International Division DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 15; 200; 30 mg/5mL; mg/5mL; mg/5mL 54859-503_1c68493c-4a56-44f4-987b-a8800cc4b44e 54859-503 HUMAN OTC DRUG Orasep Benzocaine, Menthol, Cetylpyridinium Chloride LIQUID TOPICAL 20100401 OTC MONOGRAPH FINAL part346 Llorens Pharmaceutical International Division BENZOCAINE; CETYLPYRIDINIUM CHLORIDE; MENTHOL 2; .1; .5 mL/100mL; mL/100mL; mL/100mL 54859-504_63c9d48b-72e1-45b2-bc93-b8961d0837dc 54859-504 HUMAN OTC DRUG Orasep Benzocaine, Menthol, Cetylpyridinium Chloride LIQUID TOPICAL 20100401 OTC MONOGRAPH FINAL part346 Llorens Pharmaceutical International Division BENZOCAINE; CETYLPYRIDINIUM CHLORIDE; MENTHOL 2; .1; .5 mL/100mL; mL/100mL; mL/100mL 54859-505_cf759927-a34a-431f-930e-a15e7bc3b6bd 54859-505 HUMAN OTC DRUG Tusnel Diabetic Dextromethorphan, Guaifenesin LIQUID ORAL 20031201 OTC MONOGRAPH FINAL part341 LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 54859-512_8d059a3b-2fb4-4801-a50a-e0eeca2cb4fc 54859-512 HUMAN OTC DRUG Dologesic Acetaminophen, Phenyltoloxamine Citrate, Alcohol LIQUID ORAL 19940901 OTC MONOGRAPH NOT FINAL part343 Llorens Pharmaceutical International Division ACETAMINOPHEN; ALCOHOL; PHENYLTOLOXAMINE CITRATE 500; .75; 30 mg/15mL; mL/15mL; mg/15mL 54859-520_683850e3-aa56-4514-b438-6780228d3341 54859-520 HUMAN OTC DRUG Tusnel C Codeine Phosphate, Guiafenesin, Pseudoephedrine HCl LIQUID ORAL 19950101 OTC MONOGRAPH FINAL part341 Llorens Pharmaceutical International Division CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 100; 30 mg/5mL; mg/5mL; mg/5mL CV 54859-544_c97f3d88-7332-4c54-ba1e-ca7c362f3a42 54859-544 HUMAN OTC DRUG Tusnel Pediatric Dextromethorphan, Guiafenesin, Pseudoephedrine HCl LIQUID ORAL 20060101 OTC MONOGRAPH FINAL part341 Llorens Pharmaceutical International Division DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 50; 15 mg/5mL; mg/5mL; mg/5mL 54859-602_4d96e27d-d9fc-460f-bfbb-6dd7b9185251 54859-602 HUMAN OTC DRUG Tusnel Pediatric Guiafenesin, Pseudoephedrine HCl SOLUTION/ DROPS ORAL 20060101 OTC MONOGRAPH FINAL part341 Llorens Pharmaceutical International Division GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 25; 7.5 mg/mL; mg/mL 54859-603_b9a2c7aa-d37d-4f0d-a75e-7db3c3c3d853 54859-603 HUMAN OTC DRUG Tusnel DM Pediatric Dextromethorphan, Guiafenesin, Pseudoephedrine HCl SOLUTION/ DROPS ORAL 19930101 OTC MONOGRAPH FINAL part341 Llorens Pharmaceutical International Division DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 2.5; 25; 7.5 mg/mL; mg/mL; mg/mL 54859-701_30ac92c0-60aa-4b0f-82f0-5a17f62f3702 54859-701 HUMAN PRESCRIPTION DRUG Urin D/S Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate TABLET ORAL 19990501 UNAPPROVED DRUG OTHER Llorens Pharmaceutical International Division HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .12; 81.6; 10.8; 36.2; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1 54859-702_4ea67627-d9ba-4dc7-9daf-fd8ef0cb9abe 54859-702 HUMAN OTC DRUG Conex Dexbrompheniramine Maleate, Pseudoephedrine HCl TABLET ORAL 20071101 OTC MONOGRAPH FINAL part341 LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 60 mg/1; mg/1 54859-801_ccf37bd0-cb7d-4290-81c5-0e00ba5c2800 54859-801 HUMAN OTC DRUG Tusnel Dextromethorphan HBr, Guaifenesin, Pseudoephedrine HCl TABLET ORAL 20070701 OTC MONOGRAPH FINAL part341 LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 30; 400; 60 mg/1; mg/1; mg/1 54859-802_81585939-78ee-4df2-8f65-429b017621c7 54859-802 HUMAN OTC DRUG Conex Dexbrompheniramine Maleate, Pseudoephedrine LIQUID ORAL 20071101 OTC MONOGRAPH FINAL part341 Llorens Pharmaceutical International Division DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 30 mg/5mL; mg/5mL 54866-000_e9899fa4-a6c6-464f-9441-3b29af9a9fa2 54866-000 HUMAN OTC DRUG REVITEALIZE ANTI DANDRUFF SALICYLIC ACID SHAMPOO TOPICAL 20111201 OTC MONOGRAPH FINAL part358H Camellix, LLC SALICYLIC ACID 18 mg/mL 54866-000_ef30d24a-5c15-4e78-8c7b-d389cd0ea5ac 54866-000 HUMAN OTC DRUG REVITEALIZE ANTI DANDRUFF SALICYLIC ACID SHAMPOO TOPICAL 20111201 OTC MONOGRAPH FINAL part358H Camellix, LLC SALICYLIC ACID 18 mg/mL 54866-001_274fa9e5-6f94-4ac3-b952-0a7fdeebad45 54866-001 HUMAN OTC DRUG AVERTEAX zinc oxide and Cocoa Butter CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 Camellix, LLC COCOA BUTTER; ZINC OXIDE 2.5; .15 mg/g; mg/g 54866-002_dea0cd6a-9743-4539-a694-c88cf3543525 54866-002 HUMAN OTC DRUG AVERTEAX Benzyl Alcohol CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 Camellix, LLC BENZYL ALCOHOL 10 mg/g 54866-003_0c133233-1646-4889-a4ec-a3c86c03e402 54866-003 HUMAN OTC DRUG AVERTEAX zinc oxide and Cocoa Butter OINTMENT TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 Camellix, LLC COCOA BUTTER; ZINC OXIDE 2.5; .15 mg/g; mg/g 54868-0010_0fe6a5d3-1541-4a87-8289-7f24907aa588 54868-0010 HUMAN OTC DRUG Citrate of Magnesium Citrate of Magnesium LIQUID ORAL 20030129 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. MAGNESIUM CITRATE 1.745 g/29.6mL 54868-0016_6dee501e-2e58-4ff2-901b-8f8693c776b7 54868-0016 HUMAN OTC DRUG Dulcolax bisacodyl TABLET, COATED ORAL 20100519 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. BISACODYL 5 mg/1 54868-0017_5f3d6306-fa1b-4280-9b1f-fd6f9cedc97c 54868-0017 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090512 NDA NDA020381 Physicians Total Care, Inc. NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 54868-0018_34ac3461-e6e3-4b5d-9c40-895dc9ca2d73 54868-0018 HUMAN PRESCRIPTION DRUG Erythromycin Ethylsuccinate erythromycin ethylsuccinate TABLET ORAL 19960227 ANDA ANDA061904 Physicians Total Care, Inc. ERYTHROMYCIN ETHYLSUCCINATE 400 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54868-0021_6d47c815-1af7-4a96-9daf-e1a63050cea4 54868-0021 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 19950811 ANDA ANDA090624 Physicians Total Care, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 54868-0023_77fd8181-dd74-490f-9eab-e6c47573309b 54868-0023 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19930611 ANDA ANDA062031 Physicians Total Care, Inc. DOXYCYCLINE HYCLATE 100 mg/1 54868-0024_f782fb03-7dd0-4c98-b037-94e15910ecb8 54868-0024 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 19880301 ANDA ANDA060704 Physicians Total Care, Inc. TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 54868-0025_f782fb03-7dd0-4c98-b037-94e15910ecb8 54868-0025 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 19961009 ANDA ANDA060704 Physicians Total Care, Inc. TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 54868-0026_c386e74e-03a0-499f-89c2-5e1b01b5ca52 54868-0026 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20100127 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 54868-0028_274059ad-0c68-4ec2-ab55-5f5f48a1c380 54868-0028 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19961219 ANDA ANDA089808 Physicians Total Care, Inc. THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 54868-0029_274059ad-0c68-4ec2-ab55-5f5f48a1c380 54868-0029 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20070917 ANDA ANDA089763 Physicians Total Care, Inc. THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 54868-0032_d29439a8-a95f-4d56-88e0-c1c623e2d0c4 54868-0032 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 19950127 ANDA ANDA085762 Physicians Total Care, Inc. ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 54868-0033_d045ba57-e502-40e2-b179-2724dd6cd58e 54868-0033 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19951026 ANDA ANDA084285 Physicians Total Care, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 54868-0034_6e41e4ed-c643-4924-bf9b-53ebd931b2a0 54868-0034 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20030501 ANDA ANDA078807 Physicians Total Care, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 54868-0038_7a6aaf89-a634-4ca0-a555-98e2ee813032 54868-0038 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20080110 ANDA ANDA070920 Physicians Total Care, Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-0039_7a6aaf89-a634-4ca0-a555-98e2ee813032 54868-0039 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20050111 ANDA ANDA070920 Physicians Total Care, Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-0048_ab1f78ab-63fe-4995-b0a9-77e0e9987fc3 54868-0048 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20011003 ANDA ANDA070925 Physicians Total Care, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54868-0049_ab1f78ab-63fe-4995-b0a9-77e0e9987fc3 54868-0049 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950109 ANDA ANDA070924 Physicians Total Care, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54868-0050_8d8a30ce-654a-47f5-be45-263d691c8e22 54868-0050 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 19950829 ANDA ANDA070098 Physicians Total Care, Inc. METHYLDOPA 250 mg/1 54868-0052_94674abb-9b63-4684-8e32-567c07e13cbb 54868-0052 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20030227 ANDA ANDA078955 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-0053_94674abb-9b63-4684-8e32-567c07e13cbb 54868-0053 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19961209 ANDA ANDA078955 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-0054_a0734292-7217-425b-98a3-acb7e8f2d429 54868-0054 HUMAN PRESCRIPTION DRUG GoLYTELY PEG-3350 and electrolytes POWDER, FOR SOLUTION NASOGASTRIC; ORAL 20070904 NDA NDA019011 Physicians Total Care, Inc. POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 236; 2.97; 6.74; 5.86; 22.74 g/2L; g/2L; g/2L; g/2L; g/2L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 54868-0055_da88fa99-63c7-4348-b893-00302c93e12b 54868-0055 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20000821 ANDA ANDA077002 Physicians Total Care, Inc. DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 54868-0056_80fd7466-afa0-41c5-ab2d-05315b348aa6 54868-0056 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19920922 ANDA ANDA083177 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-0057_d6595eb0-875e-4ae3-baa4-e4b955eb272c 54868-0057 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20021120 ANDA ANDA078010 Physicians Total Care, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 54868-0058_d6595eb0-875e-4ae3-baa4-e4b955eb272c 54868-0058 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19990104 ANDA ANDA078010 Physicians Total Care, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 54868-0059_0fea6c8b-9c2a-4ade-8b07-bc88e081a2fd 54868-0059 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20080819 ANDA ANDA071321 Physicians Total Care, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-0061_7c5b3625-4922-4296-b34b-5336b0ca2099 54868-0061 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19951220 ANDA ANDA072928 Physicians Total Care, Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-0062_21a83a08-cb04-448b-9897-83ec9538c9c2 54868-0062 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 19960424 ANDA ANDA071437 Physicians Total Care, Inc. DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 54868-0063_2c1543b0-c533-48b8-8620-0bebe302bf55 54868-0063 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 19940404 ANDA ANDA040804 Physicians Total Care, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 54868-0064_8426db88-8646-4230-9026-5a04c939621c 54868-0064 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19960618 ANDA ANDA085969 Physicians Total Care, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 54868-0065_8426db88-8646-4230-9026-5a04c939621c 54868-0065 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19951107 ANDA ANDA085966 Physicians Total Care, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 54868-0066_8426db88-8646-4230-9026-5a04c939621c 54868-0066 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19941004 ANDA ANDA085968 Physicians Total Care, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 54868-0070_8cae852f-c80a-4a53-b263-537fb9e59f59 54868-0070 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19941209 ANDA ANDA083116 Physicians Total Care, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-0072_9a8448b0-90a2-4e37-b72c-4a3788b83b73 54868-0072 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20030925 ANDA ANDA040419 Physicians Total Care, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 54868-0074_4ce2b8a7-5adb-4a07-8886-7e8ab0b7125c 54868-0074 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20040802 NDA NDA018858 Physicians Total Care, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-0075_4ec9fe72-03fd-418e-8b96-f0ba2bdf4004 54868-0075 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20020510 NDA NDA018832 Physicians Total Care, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 54868-0076_4ec9fe72-03fd-418e-8b96-f0ba2bdf4004 54868-0076 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 19970117 NDA NDA018877 Physicians Total Care, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 54868-0077_3bbc3f5c-6e8f-40ac-b134-63c722ea4afc 54868-0077 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride TABLET ORAL 19920813 ANDA ANDA087128 Physicians Total Care, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 54868-0079_9c261d95-a90f-4a51-a2df-852f1bb0f940 54868-0079 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 19970220 ANDA ANDA078558 Physicians Total Care, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-0080_9c261d95-a90f-4a51-a2df-852f1bb0f940 54868-0080 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 19970508 ANDA ANDA078558 Physicians Total Care, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-0087_fe987ca0-9dec-45f5-9afc-fc2e2a3caf39 54868-0087 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20080125 ANDA ANDA040526 Physicians Total Care, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 54868-0089_3bbc3f5c-6e8f-40ac-b134-63c722ea4afc 54868-0089 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride TABLET ORAL 19940705 ANDA ANDA087127 Physicians Total Care, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 54868-0091_b525c891-0d0c-4063-b4a4-542b92d12bd8 54868-0091 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19950726 ANDA ANDA070278 Physicians Total Care, Inc. HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] 54868-0092_889c93be-8a08-4704-9434-96cd6606b136 54868-0092 HUMAN PRESCRIPTION DRUG Flurazepam Hydrochloride flurazepam hydrochloride CAPSULE ORAL 19950508 ANDA ANDA070345 Physicians Total Care, Inc. FLURAZEPAM HYDROCHLORIDE 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-0097_9abf3c4f-1c7f-4196-9c54-0d7e1158c901 54868-0097 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19961001 NDA NDA019123 Physicians Total Care, Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 54868-0106_887b9788-8ac1-4e6e-9b2e-8c0e79dcd023 54868-0106 HUMAN PRESCRIPTION DRUG COREGCR CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20080825 NDA NDA022012 Physicians Total Care, Inc. CARVEDILOL PHOSPHATE 20 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 54868-0107_ea43eb69-ac9b-49ad-a88b-ad3ceb51864a 54868-0107 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20030813 ANDA ANDA073671 Physicians Total Care, Inc. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 54868-0108_a30b6cba-3acf-46d5-92e6-74d3d787e3da 54868-0108 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19961017 NDA NDA018764 Physicians Total Care, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 54868-0109_3af42a6e-4178-482c-9e96-647e289d325a 54868-0109 HUMAN PRESCRIPTION DRUG MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate TABLET ORAL 19940706 NDA AUTHORIZED GENERIC NDA011839 Physicians Total Care, Inc. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54868-0113_3a858a9c-77ae-4466-b31c-fff11fa7d469 54868-0113 HUMAN OTC DRUG Diphenhydramine Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20080423 OTC MONOGRAPH NOT FINAL part348 Physicians Total Care, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 54868-0116_7c5a4d20-a43d-4bc0-8d56-e75bcc2dad14 54868-0116 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAVENOUS 20080929 NDA NDA018800 Physicians Total Care, Inc. SODIUM CHLORIDE 9 mg/mL 54868-0117_a112d642-fac0-4857-8d63-6e21e46c2b6d 54868-0117 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, FILM COATED ORAL 20080423 NDA NDA022145 Physicians Total Care, Inc. RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] 54868-0120_9744dbae-6f6d-4103-80f0-84d6735c6abb 54868-0120 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19950424 ANDA ANDA070995 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-0121_9744dbae-6f6d-4103-80f0-84d6735c6abb 54868-0121 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19960205 ANDA ANDA070994 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-0122_a03d104e-6b42-4cfc-9e80-ec379c40057b 54868-0122 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19960409 ANDA ANDA071523 Physicians Total Care, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 54868-0127_51f8a9fc-6ab7-4629-bfda-7709964f4bfe 54868-0127 HUMAN OTC DRUG Castellani Paint Phenol LIQUID TOPICAL 20080515 OTC MONOGRAPH NOT FINAL part333A Physicians Total Care, Inc. PHENOL 15 mg/mL 54868-0133_9c261d95-a90f-4a51-a2df-852f1bb0f940 54868-0133 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 19941220 ANDA ANDA078558 Physicians Total Care, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-0147_b0faccb6-dd69-4b6d-9b67-5bc4865ee711 54868-0147 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19930923 ANDA ANDA070541 Physicians Total Care, Inc. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 54868-0153_36f7a0ae-cb8a-47e6-8719-00213e134e86 54868-0153 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20061030 ANDA ANDA065253 Physicians Total Care, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54868-0154_36f7a0ae-cb8a-47e6-8719-00213e134e86 54868-0154 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20041209 ANDA ANDA065253 Physicians Total Care, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54868-0158_a30b6cba-3acf-46d5-92e6-74d3d787e3da 54868-0158 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19950424 NDA NDA018764 Physicians Total Care, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 54868-0159_69b9bc5e-df13-4736-966a-cc9932aab38e 54868-0159 HUMAN PRESCRIPTION DRUG Probenecid Probenecid TABLET, FILM COATED ORAL 19950328 ANDA ANDA084442 Physicians Total Care, Inc. PROBENECID 500 mg/1 54868-0162_0825579e-56f9-4c3a-8c17-3a60abdc225d 54868-0162 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20050714 ANDA ANDA076258 Physicians Total Care, Inc. FENTANYL 2.55 mg/[USP'U] Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-0173_d0797250-63e3-42ba-8dc3-e3156f2c274f 54868-0173 HUMAN PRESCRIPTION DRUG METHOTREXATE methotrexate INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20030326 ANDA ANDA089343 Physicians Total Care, Inc. METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 54868-0191_77fd8181-dd74-490f-9eab-e6c47573309b 54868-0191 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 19940324 ANDA ANDA062421 Physicians Total Care, Inc. DOXYCYCLINE HYCLATE 100 mg/1 54868-0192_aede782b-4b92-4900-9213-758c1e6a15af 54868-0192 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE ORAL 19950201 ANDA ANDA087022 Physicians Total Care, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 54868-0216_b3e75380-e62d-40f8-8090-38753fca696f 54868-0216 HUMAN PRESCRIPTION DRUG Depo-Testosterone testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 19940712 ANDA ANDA085635 Physicians Total Care, Inc. TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 54868-0218_537cd838-05f2-44f4-aeb2-89c42f153e3c 54868-0218 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19940119 ANDA ANDA084612 Physicians Total Care, Inc DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-0229_2c1543b0-c533-48b8-8620-0bebe302bf55 54868-0229 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 19940728 ANDA ANDA040804 Physicians Total Care, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 54868-0234_13e4164c-eef8-4ef6-8f89-691e9efacdc3 54868-0234 HUMAN PRESCRIPTION DRUG Kenalog-10 triamcinolone acetonide INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL 20000502 NDA NDA012041 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-0235_af81170f-fbde-43ad-889d-c7c7c24783b2 54868-0235 HUMAN PRESCRIPTION DRUG Kenalog-40 triamcinolone acetonide INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 19960611 NDA NDA014901 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-0242_de53fe32-2a8e-4dd7-bea1-e29b502d8ba8 54868-0242 HUMAN PRESCRIPTION DRUG NYSTATIN Nystatin CREAM TOPICAL 19950131 ANDA ANDA064022 Physicians Total Care, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 54868-0243_6a6f2f48-f360-4f4d-a59a-22c77cd6a678 54868-0243 HUMAN PRESCRIPTION DRUG NYSTATIN nystatin SUSPENSION ORAL 19940328 ANDA ANDA062512 Physicians Total Care, Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 54868-0244_0825579e-56f9-4c3a-8c17-3a60abdc225d 54868-0244 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20050714 ANDA ANDA076258 Physicians Total Care, Inc. FENTANYL 5.1 mg/[USP'U] Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-0252_e44b17ca-493d-4510-9e52-0a1f4cb2125e 54868-0252 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate phendimetrazine tartrate TABLET ORAL 20070620 ANDA ANDA089452 Physicians Total Care, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 54868-0258_ac265bcb-510d-41b1-bf47-8eeac3bbbd66 54868-0258 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20020312 ANDA ANDA080352 Physicians Total Care, Inc. PREDNISONE 5 mg/1 54868-0261_3a77cd46-9b58-4287-a6ca-a0c5786a0c2e 54868-0261 HUMAN PRESCRIPTION DRUG Prochlorperazine Edisylate Prochlorperazine Edisylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20040726 ANDA ANDA040540 Physicians Total Care, Inc. PROCHLORPERAZINE EDISYLATE 5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54868-0262_90e5ed74-01f2-40ab-b075-798abede1e26 54868-0262 HUMAN PRESCRIPTION DRUG Promethazine promethazine hydrochloride INJECTION INTRAMUSCULAR 20020822 ANDA ANDA040454 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54868-0263_a19221d2-cd69-4e79-890e-43e063b2e1c5 54868-0263 HUMAN PRESCRIPTION DRUG Promethazine VC With Codeine Codeine Phosphate, Promethazine Hydrochloride, and Phenylephrine Hydrochloride SYRUP ORAL 19990301 ANDA ANDA040660 Physicians Total Care, Inc. CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10; 5; 6.25 mg/5mL; mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] CV 54868-0267_ed20f459-3294-4acc-b50f-9928ff55e743 54868-0267 HUMAN PRESCRIPTION DRUG Retin-A tretinoin CREAM TOPICAL 19960101 NDA NDA017522 Physicians Total Care, Inc. TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-0268_ed20f459-3294-4acc-b50f-9928ff55e743 54868-0268 HUMAN PRESCRIPTION DRUG Retin-A tretinoin CREAM TOPICAL 19960821 NDA NDA017340 Physicians Total Care, Inc. TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-0269_ed20f459-3294-4acc-b50f-9928ff55e743 54868-0269 HUMAN PRESCRIPTION DRUG Retin-A tretinoin GEL TOPICAL 19930525 NDA NDA017955 Physicians Total Care, Inc. TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-0270_ed20f459-3294-4acc-b50f-9928ff55e743 54868-0270 HUMAN PRESCRIPTION DRUG Retin-A tretinoin GEL TOPICAL 19930525 NDA NDA017579 Physicians Total Care, Inc. TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-0276_f79e0fd0-216f-4cf7-acca-be727c80bd05 54868-0276 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 19971229 ANDA ANDA074650 Physicians Total Care, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 54868-0283_c97fdea4-5416-4927-83f6-48148a002330 54868-0283 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE ORAL 19970428 ANDA ANDA040886 Physicians Total Care, inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 54868-0286_6568a3ac-3b37-40e6-9ac7-94533a6fee51 54868-0286 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, CHEWABLE ORAL 20070813 ANDA ANDA065161 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54868-0287_0825579e-56f9-4c3a-8c17-3a60abdc225d 54868-0287 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20050714 ANDA ANDA076258 Physicians Total Care, Inc. FENTANYL 7.65 mg/[USP'U] Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-0293_94674abb-9b63-4684-8e32-567c07e13cbb 54868-0293 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19930727 ANDA ANDA078955 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-0295_75cb36a3-9746-4e3a-88ad-d37d64354c51 54868-0295 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 19871222 ANDA ANDA062364 Physicians Total Care, Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-0296_4475eb8d-f9d7-4703-a460-a3ad3855e942 54868-0296 HUMAN PRESCRIPTION DRUG Dextrose Dextrose INJECTION, SOLUTION INTRAVENOUS 20061212 NDA NDA016367 Physicians Total Care, Inc. DEXTROSE MONOHYDRATE 5 g/100mL 54868-0325_c239fe20-4f79-4610-8e05-e6e0f52c509d 54868-0325 HUMAN PRESCRIPTION DRUG Dilantin phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 19950127 ANDA ANDA084349 Physicians Total Care, Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-0337_3dba3387-f213-464d-b75d-29eeacbd888c 54868-0337 HUMAN PRESCRIPTION DRUG Bactrim DS sulfamethoxazole and trimethoprim TABLET ORAL 19970826 NDA NDA017377 Physicians Total Care, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 54868-0375_44d2c2bc-d8d7-4581-bbbf-065d06aadabd 54868-0375 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine silver sulfadiazine CREAM TOPICAL 19930520 NDA NDA018578 Physicians Total Care, Inc. SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 54868-0378_92aacaba-3989-4141-8e59-8109af6bfac6 54868-0378 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 20041019 ANDA ANDA087508 Physicians Total Care, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL CV 54868-0387_3f3f31ef-a7c3-4735-8845-79a5b8a5ed85 54868-0387 HUMAN PRESCRIPTION DRUG Augmentin amoxicillin and clavulante potassium TABLET, FILM COATED ORAL 19961107 NDA NDA050564 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54868-0427_3a69020d-7cb5-4dd9-ba44-6ef8d605cd8c 54868-0427 HUMAN PRESCRIPTION DRUG Lomotil Diphenoxylate Hydrochloride TABLET ORAL 20090119 NDA NDA012462 Physicians Total Care, Inc. ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 54868-0431_bb001c15-9f5c-454e-b12d-e8664b16f80b 54868-0431 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide CREAM TOPICAL 19931208 ANDA ANDA072488 Physicians Total Care, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-0451_89977ac0-499f-427b-9c6f-3600f6ac5319 54868-0451 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20050208 NDA NDA004782 Physicians Total Care, Inc. ESTROGENS, CONJUGATED .625 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 54868-0473_ea43eb69-ac9b-49ad-a88b-ad3ceb51864a 54868-0473 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20000301 ANDA ANDA073652 Physicians Total Care, Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 54868-0520_ce005228-bed3-4940-831b-c7f8b8256d9f 54868-0520 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate CREAM TOPICAL 19951016 ANDA ANDA018861 Physicians Total Care, Inc. BETAMETHASONE VALERATE 1 mg/g 54868-0536_b5f46d0d-6971-4954-96ca-01bd0faa52eb 54868-0536 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070410 ANDA ANDA086242 Physicians Total Care, Inc. HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 54868-0538_e5925c6f-04bc-4d69-9fd4-7a122bdd6edd 54868-0538 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin SUSPENSION ORAL 19941209 ANDA ANDA065081 Physicians Total Care, Inc. CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54868-0548_afda5f51-4b06-44ef-b730-be5a86ffb097 54868-0548 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20021024 OTC MONOGRAPH FINAL part343 Physicians Total Care, Inc. ACETAMINOPHEN 325 mg/1 54868-0564_798c6ae0-0d1b-49ee-a9dd-8b652c5e031d 54868-0564 HUMAN PRESCRIPTION DRUG Cortisporin-TC colistin sulfate, neomycin sulfate, thonzonium bromide, and hydrocortisone acetate SUSPENSION AURICULAR (OTIC) 20070507 NDA NDA050356 Physicians Total Care, Inc. COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE 3; 10; 3.3; .5 mg/mL; mg/mL; mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-0586_086dda45-8f22-478c-8724-4c97b87499fe 54868-0586 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20090721 ANDA ANDA085159 Physicians Total Care, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 54868-0590_253084ff-74c6-4787-95af-3fa119dca417 54868-0590 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 20120726 ANDA ANDA040557 Physicians Total Care, Inc. METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-0601_0da34cd6-c336-4f3c-b29f-06a1eaae90ac 54868-0601 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20030218 ANDA ANDA040603 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54868-0610_3d863f8d-dac2-429c-8dc3-00763b41f1e0 54868-0610 HUMAN PRESCRIPTION DRUG Colestipol Hydrochloride colestipol hydrochloride TABLET ORAL 20070228 NDA AUTHORIZED GENERIC NDA020222 Physicians Total Care, Inc. COLESTIPOL HYDROCHLORIDE 1 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 54868-0617_38d38a30-e45d-428c-b3c9-6c56d71c7628 54868-0617 HUMAN PRESCRIPTION DRUG Diazepam Diazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020213 ANDA ANDA071583 Physicians Total Care, Inc. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-0634_242d8816-a52b-4df5-ac07-f3ebf13004b8 54868-0634 HUMAN PRESCRIPTION DRUG BLEPHAMIDE sulfacetamide sodium and prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19611001 NDA NDA012813 Physicians Total Care, Inc. PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM 2; 100 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-0644_158f00a6-9a60-40d6-8a7b-08a021c6201b 54868-0644 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940901 ANDA ANDA062447 Physicians Total Care, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54868-0649_1a1f53f2-5434-4359-b1ef-f21bed5084a9 54868-0649 HUMAN PRESCRIPTION DRUG Bacitracin Bacitracin OINTMENT OPHTHALMIC 19940429 ANDA ANDA061212 Physicians Total Care, Inc. BACITRACIN 500 [iU]/g Decreased Cell Wall Synthesis & Repair [PE] 54868-0654_a0b71c8d-c645-40a9-8e10-ccc5ec17cd4e 54868-0654 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin FOR SUSPENSION ORAL 20080304 ANDA ANDA065283 Physicians Total Care, Inc. CLARITHROMYCIN 250 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 54868-0667_a6d988da-80ed-4d4c-9eec-36aeeb274aa7 54868-0667 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride and Hydrochlorothiazide Amiloride Hydrochloride and Hydrochlorothiazide TABLET ORAL 19960516 ANDA ANDA073209 Physicians Total Care, Inc. AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-0668_79201e83-d9e6-42a7-98b6-bd51edbdc233 54868-0668 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050826 NDA NDA021259 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-0691_68cbc444-1325-4c72-ad66-9f6fef274be0 54868-0691 HUMAN PRESCRIPTION DRUG NITROSTAT Nitroglycerin TABLET ORAL 19950811 NDA NDA021134 Physicians Total Care, Inc. NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 54868-0696_94674abb-9b63-4684-8e32-567c07e13cbb 54868-0696 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19950818 ANDA ANDA078955 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-0699_2956359d-bffb-4cd1-850f-9c8d21f975bc 54868-0699 HUMAN PRESCRIPTION DRUG Spironolactone and Hydrochlorothiazide Spironolactone and Hydrochlorothiazide TABLET ORAL 19930526 ANDA ANDA086513 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 25; 25 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-0700_91fda3d6-bdfe-4dcd-84ea-32817ce41a78 54868-0700 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 19940325 ANDA ANDA040353 Physicians Total Care, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 54868-0708_0dfdc3c3-894e-46ea-ab95-840798d5a60c 54868-0708 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 19941228 ANDA ANDA064053 Physicians Total Care, Inc. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-0733_e6ce1d8c-e996-4b57-b6b3-3f312b449886 54868-0733 HUMAN PRESCRIPTION DRUG Methylphenidate Methylphenidate hydrochloride TABLET ORAL 20050324 ANDA ANDA040220 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-0735_361fbed9-bece-4912-8935-408bec774c04 54868-0735 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 19950424 ANDA ANDA089859 Physicians Total Care, Inc. CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 54868-0736_c9aa61c7-8870-4641-9b68-dc761eb6070b 54868-0736 HUMAN PRESCRIPTION DRUG Antibiotic Ear (Neo/Polym/HC) Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 Physicians Total Care, Inc. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-0762_2dae6094-9c74-4fbc-84da-4ac6f3857a13 54868-0762 HUMAN PRESCRIPTION DRUG Cyanocobalamin cyanocobalamin INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20030918 ANDA ANDA080737 Physicians Total Care, Inc. CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 54868-0765_bff10dca-7798-480b-9e0d-397161cc6756 54868-0765 HUMAN PRESCRIPTION DRUG GLYCOPYRROLATE glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110506 NDA NDA017558 Physicians Total Care, Inc. GLYCOPYRROLATE .2 mg/mL 54868-0767_89085b2b-c676-4f2f-9ed4-2e04986fe137 54868-0767 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20070316 ANDA ANDA080205 Physicians Total Care, Inc. POTASSIUM CHLORIDE 149 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 54868-0792_80fd7466-afa0-41c5-ab2d-05315b348aa6 54868-0792 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19951004 ANDA ANDA083177 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-0795_723ef500-4b12-4d0d-b926-ae59e21fe0e0 54868-0795 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20070430 ANDA ANDA077270 Physicians Total Care, Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-0800_0ae08af3-f42a-4025-b137-f104de54d9ce 54868-0800 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19930106 ANDA ANDA071293 Physicians Total Care, Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 54868-0802_1c3b841f-d9cb-40ed-ac92-387e2a79bacc 54868-0802 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium clorazepate dipotassium TABLET ORAL 19961003 ANDA ANDA071858 Physicians Total Care, Inc. CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-0805_11c40932-8c8f-4a48-8b1f-c0fa4c7dbaa7 54868-0805 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20070917 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-0816_e267b61d-1b16-4620-8f66-d62b5e31d19d 54868-0816 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19960404 ANDA ANDA040245 Physicians Total Care, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 54868-0818_1a77dadd-9c05-4f77-9b5e-7771c69be2da 54868-0818 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19950123 ANDA ANDA040161 Physicians Total Care, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 54868-0823_f25888eb-e871-4f73-a93d-cfda73a099c2 54868-0823 HUMAN PRESCRIPTION DRUG Felodipine felodipine TABLET, FILM COATED ORAL 20051108 ANDA ANDA075896 Physicians Total Care, Inc. FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54868-0826_f25888eb-e871-4f73-a93d-cfda73a099c2 54868-0826 HUMAN PRESCRIPTION DRUG Felodipine felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050121 ANDA ANDA075896 Physicians Total Care, Inc. FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54868-0836_ac265bcb-510d-41b1-bf47-8eeac3bbbd66 54868-0836 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20020415 ANDA ANDA084122 Physicians Total Care, Inc. PREDNISONE 10 mg/1 54868-0840_776a59d7-9876-49e5-96c8-fe45230c6e49 54868-0840 HUMAN PRESCRIPTION DRUG Ery-Tab erythromycin TABLET, DELAYED RELEASE ORAL 19990928 ANDA ANDA062298 Physicians Total Care, Inc. ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54868-0843_53a3532a-770a-4857-8a2c-661ccb8b84d3 54868-0843 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19950222 ANDA ANDA086414 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-0844_634d0e7d-3160-42d7-b2cf-f1ab9ac6ac84 54868-0844 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19950222 ANDA ANDA085692 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE 5 mg/g 54868-0845_31cc3a65-8c42-4469-9787-7622ae456f84 54868-0845 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20071009 ANDA ANDA077884 Physicians Total Care, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 54868-0846_31cc3a65-8c42-4469-9787-7622ae456f84 54868-0846 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20090701 ANDA ANDA077884 Physicians Total Care, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 54868-0854_8fb54677-a6b7-4c9d-88fb-f7abc1ba13e5 54868-0854 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol CAPSULE, EXTENDED RELEASE ORAL 20070502 ANDA ANDA078065 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-0860_9a8448b0-90a2-4e37-b72c-4a3788b83b73 54868-0860 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20090708 ANDA ANDA040419 Physicians Total Care, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 54868-0875_4ce2b8a7-5adb-4a07-8886-7e8ab0b7125c 54868-0875 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 19990727 ANDA ANDA070624 Physicians Total Care, Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-0879_6a31de21-7f3b-428e-9c95-76b8f7271f81 54868-0879 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20070704 ANDA ANDA071891 Physicians Total Care, Inc. SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-0890_54642793-18db-4fca-9056-a2ca5a740e59 54868-0890 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 19950807 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-0908_ac265bcb-510d-41b1-bf47-8eeac3bbbd66 54868-0908 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20091210 ANDA ANDA084283 Physicians Total Care, Inc. PREDNISONE 50 mg/1 54868-0916_537cd838-05f2-44f4-aeb2-89c42f153e3c 54868-0916 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19960510 ANDA ANDA084613 Physicians Total Care, Inc DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-0922_cfecce09-96dc-4fbe-b045-999f77e91623 54868-0922 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 19950426 ANDA ANDA074464 Physicians Total Care, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-0927_537cd838-05f2-44f4-aeb2-89c42f153e3c 54868-0927 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20090128 ANDA ANDA084611 Physicians Total Care, Inc DEXAMETHASONE .5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-0935_11c40932-8c8f-4a48-8b1f-c0fa4c7dbaa7 54868-0935 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20081024 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-0937_b45d4341-5024-48c3-9608-e7c602d84453 54868-0937 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 20040817 ANDA ANDA061454 Physicians Total Care, Inc. DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54868-0946_84620585-df4d-483b-bab8-d904ffb0220c 54868-0946 HUMAN PRESCRIPTION DRUG Erythromycin erythromycin SOLUTION TOPICAL 19960329 ANDA ANDA064187 Physicians Total Care, Inc. ERYTHROMYCIN 20 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54868-0971_da5a96d1-9f4b-439b-890e-a39bc29bdf5e 54868-0971 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION ORAL 20001011 ANDA ANDA062759 Physicians Total Care, Inc. ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL 200; 600 mg/5mL; mg/5mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient] 54868-0973_66df8564-8239-4078-ba9a-35a11cfb36e7 54868-0973 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 19941215 ANDA ANDA019137 Physicians Total Care, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-0984_13daa2c3-6403-4379-9be0-5646677fa9a2 54868-0984 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20071016 ANDA ANDA075661 Physicians Total Care, Inc. IBUPROFEN 200 mg/1 54868-0988_0fea6c8b-9c2a-4ade-8b07-bc88e081a2fd 54868-0988 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20040603 ANDA ANDA071322 Physicians Total Care, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-1029_30004e84-7a7b-46ac-b6fe-bd1835dd9fcf 54868-1029 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20010213 ANDA ANDA040650 Physicians Total Care, Inc. CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CV 54868-1036_24450668-ed5c-4651-9365-6f3d3bc102e4 54868-1036 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 20040621 ANDA ANDA089718 Physicians Total Care, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 54868-1037_cb730544-1622-46e5-b5ae-9586dbcec689 54868-1037 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, Caffeine and Codeine Phosphate Butalbital, Aspirin, Caffeine and Codeine Phosphate CAPSULE ORAL 19980602 ANDA ANDA074359 Physicians Total Care, Inc. ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 54868-1040_536a3711-8e82-4393-82f2-910dcbde9468 54868-1040 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate gentamicin sulfate OINTMENT OPHTHALMIC 19940921 ANDA ANDA065024 Physicians Total Care, Inc. GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 54868-1050_3144133b-0993-4e96-b5c1-78a79dbad72b 54868-1050 HUMAN OTC DRUG diphenhydramine hydrochloride diphenhydramine hydrochloride CAPSULE ORAL 20000501 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 54868-1060_53a3532a-770a-4857-8a2c-661ccb8b84d3 54868-1060 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19941122 ANDA ANDA086415 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-1070_a805e81e-de84-422d-bb26-22aae20a3412 54868-1070 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone neomycin sulfate, polymyxin b sulfate and dexamethasone SUSPENSION OPHTHALMIC 20071204 ANDA ANDA062721 Physicians Total Care, Inc. DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-1073_0319ae11-7457-4e15-98f5-a0a6bcaff666 54868-1073 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate TABLET ORAL 19930813 ANDA ANDA072637 Physicians Total Care, Inc. ALBUTEROL SULFATE 2.4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 54868-1078_3330f4f5-55fd-4d62-b80d-fbea0340399e 54868-1078 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130627 ANDA ANDA078494 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-1082_a5ed6899-9939-456c-9735-a418b7ce6357 54868-1082 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 20000107 ANDA ANDA040101 Physicians Total Care, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54868-1093_54642793-18db-4fca-9056-a2ca5a740e59 54868-1093 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 19960924 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-1103_086dda45-8f22-478c-8724-4c97b87499fe 54868-1103 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20030714 ANDA ANDA085159 Physicians Total Care, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 54868-1110_b34b187e-d110-48df-9687-c255eec7910f 54868-1110 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 19970317 ANDA ANDA071611 Physicians Total Care, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 54868-1118_6a31de21-7f3b-428e-9c95-76b8f7271f81 54868-1118 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20070705 ANDA ANDA071795 Physicians Total Care, Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-1119_ac265bcb-510d-41b1-bf47-8eeac3bbbd66 54868-1119 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20041005 ANDA ANDA087800 Physicians Total Care, Inc. PREDNISONE 1 mg/1 54868-1129_01172abb-07b0-4cc9-ab0c-8922c8993c44 54868-1129 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20070719 ANDA ANDA077122 Physicians Total Care, Inc. DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 54868-1157_4f8bce58-fbdc-44ce-b809-4da45d92ff7b 54868-1157 HUMAN PRESCRIPTION DRUG BLEPHAMIDE sulfacetamide sodium and prednisolone acetate OINTMENT OPHTHALMIC 20120304 ANDA ANDA087748 Physicians Total Care, Inc. PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM 2; 100 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-1171_c3a479d1-7c29-46cf-aa03-080c5b64f28c 54868-1171 HUMAN PRESCRIPTION DRUG Penicillin V Potasium Penicillin V Potasium TABLET ORAL 20030930 ANDA ANDA064071 Physicians Total Care, Inc. PENICILLIN V POTASSIUM 250 mg/1 54868-1173_c3a479d1-7c29-46cf-aa03-080c5b64f28c 54868-1173 HUMAN PRESCRIPTION DRUG Penicillin V Potasium Penicillin V Potasium TABLET ORAL 19950222 ANDA ANDA064071 Physicians Total Care, Inc. PENICILLIN V POTASSIUM 500 mg/1 54868-1183_ac265bcb-510d-41b1-bf47-8eeac3bbbd66 54868-1183 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030819 ANDA ANDA087342 Physicians Total Care, Inc. PREDNISONE 20 mg/1 54868-1192_3fa75a0d-6a68-4ba5-87c9-69520fa4dad4 54868-1192 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin and Polymyxin B Sulfates and Dexamethasone OINTMENT OPHTHALMIC 20021111 ANDA ANDA064063 Physicians Total Care, Inc. DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-1195_bdc25457-b62a-4b2f-8304-440fad1a06bc 54868-1195 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 20100209 ANDA ANDA084840 Physicians Total Care, Inc. ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 54868-1198_95947bb4-46bb-435d-bb1c-d646aa556fdb 54868-1198 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19950227 OTC MONOGRAPH FINAL part343 Physicians Total Care, Inc. ASPIRIN 325 mg/1 54868-1199_e17cb260-9274-43d0-9d9a-fa590b82d681 54868-1199 HUMAN PRESCRIPTION DRUG Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate OINTMENT OPHTHALMIC 20041112 ANDA ANDA064028 Physicians Total Care, Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 54868-1207_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-1207 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20050112 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-1223_a03d104e-6b42-4cfc-9e80-ec379c40057b 54868-1223 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19970508 ANDA ANDA071524 Physicians Total Care, Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 54868-1227_4a3ced1f-cd7a-4b39-b0cf-63f4c7bbe4dc 54868-1227 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride LIQUID ORAL 20021022 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 54868-1233_a8fc7135-51ab-4d13-b743-333823956941 54868-1233 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 20090914 ANDA ANDA040191 Physicians Total Care, Inc. MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-1234_3a76a4d0-bd0f-409e-adf0-0cbaae53243c 54868-1234 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20120817 ANDA ANDA079234 Physicians Total Care, Inc. TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 54868-1239_dadf8ed3-b155-4449-a74e-1ebdf9b10a06 54868-1239 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20070122 ANDA ANDA077031 Physicians Total Care, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-1259_d975e88b-476c-463b-9600-3fbcdb0e86f2 54868-1259 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20041115 NDA NDA009218 Physicians Total Care, Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54868-1317_ee02d645-3e12-4f1e-97cb-167be847aa76 54868-1317 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 19960411 ANDA ANDA070980 Physicians Total Care, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 54868-1323_b0edb786-44c1-43ea-afc0-78df4970ce86 54868-1323 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19950814 ANDA ANDA040863 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54868-1326_9ecceec7-df5f-4210-a52f-086f1859e8fb 54868-1326 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE, LIQUID FILLED ORAL 20090129 ANDA ANDA072579 Physicians Total Care, Inc. NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54868-1328_8d8a30ce-654a-47f5-be45-263d691c8e22 54868-1328 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 19960726 ANDA ANDA070343 Physicians Total Care, Inc. METHYLDOPA 500 mg/1 54868-1332_5b7afa4a-3bbd-4a32-a465-ca745471e174 54868-1332 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20030521 ANDA ANDA040537 Physicians Total Care, Inc. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 54868-1334_55592f54-580b-4049-bbab-d82e7c3255a4 54868-1334 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19941209 ANDA ANDA073589 Physicians Total Care, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 54868-1335_bd26a0a2-2f4c-47ae-948f-e6868ac91132 54868-1335 HUMAN PRESCRIPTION DRUG LITHIUM CARBONATE Lithium Carbonate CAPSULE ORAL 19950116 ANDA ANDA090702 Physicians Total Care, Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 54868-1338_7c5b3625-4922-4296-b34b-5336b0ca2099 54868-1338 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19930723 ANDA ANDA072927 Physicians Total Care, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-1344_5fecfa8f-183c-42f2-af2f-397b66a891d5 54868-1344 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19930202 ANDA ANDA090442 Physicians Total Care, Inc. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 54868-1362_a7a881da-c9ca-4b26-b58c-20f8552a360d 54868-1362 HUMAN PRESCRIPTION DRUG SELENIUM SULFIDE SELENIUM SULFIDE LOTION TOPICAL 20060925 ANDA ANDA089996 Physicians Total Care, Inc. SELENIUM SULFIDE 2.5 g/100mL 54868-1380_b45d4341-5024-48c3-9608-e7c602d84453 54868-1380 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19921021 ANDA ANDA061454 Physicians Total Care, Inc. DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54868-1385_e5925c6f-04bc-4d69-9fd4-7a122bdd6edd 54868-1385 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin SUSPENSION ORAL 19930622 ANDA ANDA065081 Physicians Total Care, Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54868-1386_08ea9c20-4cfb-4297-8819-0d1ccfa22394 54868-1386 HUMAN PRESCRIPTION DRUG Erythromycin Base Filmtab Erythromycin TABLET, FILM COATED ORAL 19950721 ANDA ANDA061621 Physicians Total Care, Inc. ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54868-1387_08ea9c20-4cfb-4297-8819-0d1ccfa22394 54868-1387 HUMAN PRESCRIPTION DRUG Erythromycin Base Filmtab Erythromycin TABLET, FILM COATED ORAL 19961209 ANDA ANDA061621 Physicians Total Care, Inc. ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54868-1425_30d87f61-2606-4509-bf4c-6cfb97b4ea68 54868-1425 HUMAN PRESCRIPTION DRUG Nystatin nystatin OINTMENT TOPICAL 20070411 ANDA ANDA062124 Physicians Total Care, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 54868-1429_2232ce07-e218-4907-8f20-1e8fe3277dde 54868-1429 HUMAN OTC DRUG Humulin N Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 19941024 NDA NDA018781 Physicians Total Care, Inc. INSULIN HUMAN 100 [iU]/mL 54868-1432_f0646bea-d356-441c-8b53-a89245a3762c 54868-1432 HUMAN PRESCRIPTION DRUG Cenestin synthetic conjugated estrogens, A TABLET, FILM COATED ORAL 20080317 NDA NDA020992 Physicians Total Care, Inc. ESTROGENS, CONJUGATED SYNTHETIC A 1.25 mg/1 54868-1461_274059ad-0c68-4ec2-ab55-5f5f48a1c380 54868-1461 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20070704 ANDA ANDA089807 Physicians Total Care, Inc. THEOPHYLLINE ANHYDROUS 100 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 54868-1462_e13f3086-bfe3-45b6-9842-efad504a4d95 54868-1462 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Immediate-Release Diethylpropion hydrochloride TABLET ORAL 20040614 NDA NDA011722 Physicians Total Care, Inc. DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 54868-1463_e13f3086-bfe3-45b6-9842-efad504a4d95 54868-1463 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 20051003 NDA NDA012546 Physicians Total Care, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 54868-1486_c239fe20-4f79-4610-8e05-e6e0f52c509d 54868-1486 HUMAN PRESCRIPTION DRUG Dilantin phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20030819 ANDA ANDA084349 Physicians Total Care, Inc. PHENYTOIN SODIUM 30 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-1517_8fb54677-a6b7-4c9d-88fb-f7abc1ba13e5 54868-1517 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol CAPSULE, EXTENDED RELEASE ORAL 20070330 ANDA ANDA078065 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-1518_8fb54677-a6b7-4c9d-88fb-f7abc1ba13e5 54868-1518 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol CAPSULE, EXTENDED RELEASE ORAL 19940314 ANDA ANDA078065 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-1523_0825579e-56f9-4c3a-8c17-3a60abdc225d 54868-1523 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20050714 ANDA ANDA076258 Physicians Total Care, Inc. FENTANYL 10.2 mg/[USP'U] Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-1531_68c1b49b-a16c-40a9-9b5e-76df9e8d19e2 54868-1531 HUMAN PRESCRIPTION DRUG Cortisporin neomycin sulfate, polymyxin B sulfate and hydrocortisone acetate CREAM TOPICAL 19940719 NDA NDA050218 Physicians Total Care, Inc. HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 5; 3.5; 10000 mg/g; mg/g; U/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-1538_68cbc444-1325-4c72-ad66-9f6fef274be0 54868-1538 HUMAN PRESCRIPTION DRUG NITROSTAT Nitroglycerin TABLET ORAL 19940922 NDA NDA021134 Physicians Total Care, Inc. NITROGLYCERIN .3 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 54868-1547_a6a3998d-d6aa-40c3-8959-955670b5c0db 54868-1547 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071995 Physicians Total Care, Inc. PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 54868-1587_9db4dca1-1472-4246-8366-219c621f9e5f 54868-1587 HUMAN OTC DRUG Sarna pramoxine hydrochloride LOTION TOPICAL 20080328 OTC MONOGRAPH NOT FINAL part348 Physicians Total Care, Inc. PRAMOXINE HYDROCHLORIDE 1 mg/mL 54868-1590_ba942508-13d1-4523-a66a-c8534c3285c3 54868-1590 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 19941122 ANDA ANDA087356 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-1591_ba942508-13d1-4523-a66a-c8534c3285c3 54868-1591 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20060918 ANDA ANDA087357 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-1613_8763e5a9-9b87-493d-83d2-78042b0feed7 54868-1613 HUMAN PRESCRIPTION DRUG PROMETHEGAN Promethazine Hydrochloride SUPPOSITORY RECTAL 19960617 ANDA ANDA087165 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54868-1616_86e46afc-1269-4276-9985-2bb93fabd31e 54868-1616 HUMAN PRESCRIPTION DRUG Trimethoprim Trimethoprim TABLET ORAL 20120502 ANDA ANDA070049 Physicians Total Care, Inc. TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 54868-1625_c040076a-7a92-4b40-9513-6c15d9cda22f 54868-1625 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 19950814 ANDA ANDA040855 Physicians Total Care, Inc. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 54868-1629_48577869-8c72-416e-b7fc-ee1de333a6d4 54868-1629 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 20070705 ANDA ANDA072423 Physicians Total Care, Inc. MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54868-1689_e91e3031-9e0d-41f2-a6da-b04390daaab3 54868-1689 HUMAN PRESCRIPTION DRUG Valproic Valproic Acid CAPSULE, LIQUID FILLED ORAL 19940419 ANDA ANDA073229 Physicians Total Care, Inc. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 54868-1691_fed8d510-c787-407c-8748-a41c6e8cc4a0 54868-1691 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20090727 ANDA ANDA084903 Physicians Total Care, Inc. PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-1700_a1a2b20f-2261-4d4f-8bd8-bac39ed027bf 54868-1700 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20091103 ANDA ANDA087463 Physicians Total Care, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-1704_e6ce1d8c-e996-4b57-b6b3-3f312b449886 54868-1704 HUMAN PRESCRIPTION DRUG Methylphenidate methylphenidate hydrochloride TABLET ORAL 20090514 ANDA ANDA040220 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-1729_84cf82fa-837a-4b2c-a280-6751f38b0c26 54868-1729 HUMAN PRESCRIPTION DRUG Depo-Estradiol estradiol cypionate INJECTION INTRAMUSCULAR 19981016 ANDA ANDA085470 Physicians Total Care, Inc. ESTRADIOL CYPIONATE 5 mg/mL 54868-1743_4df671d1-d0ea-4ae0-8385-bb9630ada6b8 54868-1743 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 20070705 ANDA ANDA083365 Physicians Total Care, Inc. HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-1744_537cd838-05f2-44f4-aeb2-89c42f153e3c 54868-1744 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19960621 ANDA ANDA084610 Physicians Total Care, Inc DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-1750_b8427898-2a74-41d0-aed2-4839df76e139 54868-1750 HUMAN PRESCRIPTION DRUG Cytomel liothyronine sodium TABLET ORAL 20021230 NDA NDA010379 Physicians Total Care, Inc. LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 54868-1760_ed20f459-3294-4acc-b50f-9928ff55e743 54868-1760 HUMAN PRESCRIPTION DRUG Retin-A tretinoin CREAM TOPICAL 19930528 NDA NDA019049 Physicians Total Care, Inc. TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-1780_9185f276-5046-4707-9287-6c4662b1c18f 54868-1780 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 20031110 ANDA ANDA060456 Physicians Total Care, Inc. PENICILLIN V POTASSIUM 250 mg/5mL 54868-1791_931dba86-5a94-4921-953b-68774aedd1f4 54868-1791 HUMAN OTC DRUG Acetaminophen Acetaminophen LIQUID ORAL 20040707 OTC MONOGRAPH FINAL part343 Physicians Total Care, Inc. ACETAMINOPHEN 160 mg/5mL 54868-1795_e4958f97-9164-4b61-8d8c-33f634a9952c 54868-1795 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 19950515 NDA NDA006488 Physicians Total Care, Inc. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 54868-1796_e4958f97-9164-4b61-8d8c-33f634a9952c 54868-1796 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION; PERINEURAL 19950515 NDA NDA006488 Physicians Total Care, Inc. EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 10 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 54868-1798_e4958f97-9164-4b61-8d8c-33f634a9952c 54868-1798 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 19931109 NDA NDA006488 Physicians Total Care, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 54868-1802_8e359d73-d777-49d9-af50-724344f1a879 54868-1802 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20070214 ANDA ANDA078211 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-1804_2c1543b0-c533-48b8-8620-0bebe302bf55 54868-1804 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 19930921 ANDA ANDA040804 Physicians Total Care, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 54868-1819_a097b2cb-9177-4e62-a4b6-cd40fefe6c83 54868-1819 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080523 ANDA ANDA077873 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-1827_859c27a4-912c-4623-b6af-e819aad79ad0 54868-1827 HUMAN PRESCRIPTION DRUG LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 20030508 ANDA ANDA040014 Physicians Total Care, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 54868-1852_4ed8e07c-0fb2-4bfe-86c3-8e4196d98ecb 54868-1852 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050120 ANDA ANDA075665 Physicians Total Care, Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-1857_d1a436e2-b35a-4bf2-9386-da4190a4c03e 54868-1857 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 19980929 ANDA ANDA065061 Physicians Total Care, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 54868-1866_abda8405-5e00-46b9-aa1e-742743e5a3e0 54868-1866 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19950424 ANDA ANDA072011 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-1867_97fa8e59-d2cc-4f67-9fb8-0e1b3ce6885a 54868-1867 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SYRUP ORAL 19941219 ANDA ANDA087953 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54868-1871_c0f9e181-57bf-4442-bfc0-b6711f0e3a41 54868-1871 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950424 ANDA ANDA077877 Physicians Total Care, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-1873_6e41e4ed-c643-4924-bf9b-53ebd931b2a0 54868-1873 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20030327 ANDA ANDA078807 Physicians Total Care, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 54868-1890_ec82c251-eebc-4210-9920-6cd5a827a177 54868-1890 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20041101 NDA NDA021366 Physicians Total Care, Inc. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-1934_9c4972f6-6db3-468b-be1a-1af272dd1ed3 54868-1934 HUMAN OTC DRUG Tussin DM Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 20090203 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 54868-1947_9ae532e0-67f1-40bb-8bb5-a8fdf168b679 54868-1947 HUMAN OTC DRUG Saline Nasal Saline Nasal SPRAY NASAL 20021227 OTC MONOGRAPH FINAL part349 Physicians Total Care, Inc. SODIUM CHLORIDE 6.5 mg/mL 54868-1949_b5f46d0d-6971-4954-96ca-01bd0faa52eb 54868-1949 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070917 ANDA ANDA086242 Physicians Total Care, Inc. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 54868-1959_a03d104e-6b42-4cfc-9e80-ec379c40057b 54868-1959 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19920220 ANDA ANDA071525 Physicians Total Care, Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 54868-1964_21a83a08-cb04-448b-9897-83ec9538c9c2 54868-1964 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 19990928 ANDA ANDA071595 Physicians Total Care, Inc. DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 54868-1967_ab1f78ab-63fe-4995-b0a9-77e0e9987fc3 54868-1967 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20041130 ANDA ANDA070923 Physicians Total Care, Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54868-1971_c0f9e181-57bf-4442-bfc0-b6711f0e3a41 54868-1971 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19990304 ANDA ANDA077877 Physicians Total Care, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-1973_08081de2-2096-499e-b5b3-067fbbbef571 54868-1973 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 20021125 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 54868-1978_4ed8e07c-0fb2-4bfe-86c3-8e4196d98ecb 54868-1978 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050120 ANDA ANDA075665 Physicians Total Care, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-1980_59a95728-34a6-4741-8807-cba7da17e1ab 54868-1980 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20071109 ANDA ANDA078332 Physicians Total Care, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 54868-1986_7704aea8-fedc-40b6-bd09-b0cb2c40b00f 54868-1986 HUMAN OTC DRUG Guaifenesin DM Guaifenesin and Dextromethorphan Hydrobromide SYRUP ORAL 19991116 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 54868-1990_9f2ecbab-8244-47c9-bcef-d8d0a4420af5 54868-1990 HUMAN PRESCRIPTION DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL 20071004 ANDA ANDA040649 Physicians Total Care, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54868-1992_5192b19b-5bd1-4f62-9cad-b120de7dbb74 54868-1992 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20041027 ANDA ANDA089773 Physicians Total Care, Inc. NITROGLYCERIN 10 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 54868-2007_ac5fc20b-8837-4294-b783-8aa6a0c90412 54868-2007 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 20030609 ANDA ANDA086831 Physicians Total Care, Inc. CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 54868-2032_7fbb6c19-6d9f-48f0-85f7-9583248d654b 54868-2032 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride SOLUTION ORAL 19940801 ANDA ANDA040010 Physicians Total Care, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 54868-2038_27378bdf-dca8-42b0-8727-fb22c43d9f10 54868-2038 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20061219 ANDA ANDA040420 Physicians Total Care, Inc. PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-2062_6c02417b-bbde-4946-a69e-38f01c258ce2 54868-2062 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20000615 ANDA ANDA070254 Physicians Total Care, Inc. NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 54868-2064_810f5846-8f33-4039-91de-88d2ffd5d822 54868-2064 HUMAN PRESCRIPTION DRUG LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 19940823 ANDA ANDA088327 Physicians Total Care, Inc. LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 54868-2077_dd6128c5-b642-470c-beb2-352c1ff5df0f 54868-2077 HUMAN PRESCRIPTION DRUG Levocetirizine dihydrochloride Levocetirizine dihydrochloride TABLET ORAL 20101230 ANDA ANDA090229 Physicians Total Care, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 54868-2088_230ef06f-75a4-4bc7-942c-63ab2c7cbec8 54868-2088 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20050929 ANDA ANDA040737 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54868-2093_d4312878-bdb9-4241-98e0-c77553ca4286 54868-2093 HUMAN OTC DRUG Maalox Antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20061212 OTC MONOGRAPH FINAL part332 Physicians Total Care, Inc. ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 54868-2094_7c144dee-76e9-4ec7-be01-0219ceb29ad2 54868-2094 HUMAN PRESCRIPTION DRUG Oxycodone and Aspirin oxycodone and aspirin TABLET ORAL 19980227 ANDA ANDA040255 Physicians Total Care, Inc. ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE 325; 4.5; .38 mg/1; mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 54868-2118_19b1a56b-4e29-4973-9ca0-b3902db4f69d 54868-2118 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 19960620 ANDA ANDA072741 Physicians Total Care, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 54868-2126_0fea6c8b-9c2a-4ade-8b07-bc88e081a2fd 54868-2126 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20080723 ANDA ANDA071307 Physicians Total Care, Inc. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-2128_d975e88b-476c-463b-9600-3fbcdb0e86f2 54868-2128 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20040927 NDA NDA009218 Physicians Total Care, Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54868-2131_11c40932-8c8f-4a48-8b1f-c0fa4c7dbaa7 54868-2131 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20050309 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-2133_1c3b841f-d9cb-40ed-ac92-387e2a79bacc 54868-2133 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium clorazepate dipotassium TABLET ORAL 19960524 ANDA ANDA071858 Physicians Total Care, Inc. CLORAZEPATE DIPOTASSIUM 3.75 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-2134_da88fa99-63c7-4348-b893-00302c93e12b 54868-2134 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 19920922 ANDA ANDA077002 Physicians Total Care, Inc. DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 54868-2143_c5bb6eaa-189b-4632-bd2f-ea0183c680b3 54868-2143 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 19950804 ANDA ANDA089682 Physicians Total Care, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-2145_7c5b3625-4922-4296-b34b-5336b0ca2099 54868-2145 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19930629 ANDA ANDA072926 Physicians Total Care, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-2149_9aab3cb6-b28f-46e0-bcab-227f8d47cae7 54868-2149 HUMAN PRESCRIPTION DRUG Cardizem CD Diltiazem Hydrochloride CAPSULE ORAL 19930616 NDA NDA020062 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-2157_b4a37481-c0d3-43dc-85f1-8cca6c6d8ba8 54868-2157 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20061211 ANDA ANDA071655 Physicians Total Care, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54868-2176_4a4d57fc-38b3-48a9-af44-abacdb20edbf 54868-2176 HUMAN PRESCRIPTION DRUG Cytotec misoprostol TABLET ORAL 19960702 NDA NDA019268 Physicians Total Care, Inc. MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 54868-2180_d6595eb0-875e-4ae3-baa4-e4b955eb272c 54868-2180 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19970303 ANDA ANDA078010 Physicians Total Care, Inc. FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 54868-2183_5192b19b-5bd1-4f62-9cad-b120de7dbb74 54868-2183 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20041012 ANDA ANDA089772 Physicians Total Care, Inc. NITROGLYCERIN 5 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 54868-2185_f96d2943-9a0e-47b5-8c05-3d61ded6b051 54868-2185 HUMAN PRESCRIPTION DRUG Naftin naftifine hydrochloride GEL TOPICAL 20051229 NDA NDA019356 Physicians Total Care, Inc. NAFTIFINE HYDROCHLORIDE 10 mg/g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 54868-2198_311a004f-9402-46ba-85bd-a211aadaed57 54868-2198 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20050121 ANDA ANDA074131 Physicians Total Care, Inc. PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-2199_311a004f-9402-46ba-85bd-a211aadaed57 54868-2199 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 19941006 ANDA ANDA074131 Physicians Total Care, Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-2200_5c7fe409-289d-43d1-a9d4-1ee8eda9b07c 54868-2200 HUMAN PRESCRIPTION DRUG Verelan verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 20040812 NDA NDA019614 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-2207_5651bc48-1227-4ca9-aaf9-805771c27090 54868-2207 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000509 ANDA ANDA074587 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-2211_cf206f2d-793d-4301-a75a-ed2b1d90ba4c 54868-2211 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20080807 ANDA ANDA078306 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 100 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-2221_5fecfa8f-183c-42f2-af2f-397b66a891d5 54868-2221 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19921112 ANDA ANDA090441 Physicians Total Care, Inc. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 54868-2223_e3320c0b-0507-4e09-a5c5-631a64e4b90a 54868-2223 HUMAN PRESCRIPTION DRUG Elocon mometasone furoate CREAM TOPICAL 19940531 NDA NDA019625 Physicians Total Care, Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 54868-2240_f8b3199b-55fe-4ecb-a66c-08840d44f177 54868-2240 HUMAN PRESCRIPTION DRUG Naftin naftifine hydrochloride CREAM TOPICAL 20100617 NDA NDA019599 Physicians Total Care, Inc. NAFTIFINE HYDROCHLORIDE 10 mg/g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 54868-2252_d975e88b-476c-463b-9600-3fbcdb0e86f2 54868-2252 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 19950731 NDA NDA009218 Physicians Total Care, Inc. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54868-2264_3fa6b141-44f0-4e51-bd46-1127d540dd9b 54868-2264 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide SOLUTION TOPICAL 19960403 ANDA ANDA088167 Physicians Total Care, Inc. FLUOCINOLONE ACETONIDE .1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-2271_54642793-18db-4fca-9056-a2ca5a740e59 54868-2271 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20001205 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM .3 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-2276_4c3e2bbe-6a22-45ad-be50-3ba6281a6d07 54868-2276 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20050301 ANDA ANDA072838 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-2277_4c3e2bbe-6a22-45ad-be50-3ba6281a6d07 54868-2277 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19960516 ANDA ANDA072838 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-2284_21a83a08-cb04-448b-9897-83ec9538c9c2 54868-2284 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 19961003 ANDA ANDA071422 Physicians Total Care, Inc. DOXEPIN HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 54868-2290_4c3e2bbe-6a22-45ad-be50-3ba6281a6d07 54868-2290 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19950424 ANDA ANDA072838 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-2296_b525c891-0d0c-4063-b4a4-542b92d12bd8 54868-2296 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19961024 ANDA ANDA070278 Physicians Total Care, Inc. HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 54868-2298_e23185a6-9adb-4fbf-93a6-946cfc655419 54868-2298 HUMAN OTC DRUG Kaopectate Regular Strength Vanilla Flavor Anti Diarrheal bismuth subsalicylate LIQUID ORAL 20080512 OTC MONOGRAPH FINAL part335 Physicians Total Care, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL 54868-2299_b2442be8-4bea-4091-8ef2-28b2a8b2fb93 54868-2299 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION INTRAVENOUS 20050929 ANDA ANDA018579 Physicians Total Care, Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 54868-2314_9a6689c1-b181-4395-a2d7-772bafb3aa7b 54868-2314 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 19950927 ANDA ANDA040765 Physicians Total Care, Inc. FOLIC ACID 1 mg/1 54868-2317_21a83a08-cb04-448b-9897-83ec9538c9c2 54868-2317 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 19950103 ANDA ANDA071697 Physicians Total Care, Inc. DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 54868-2319_fad3dfbe-5257-4305-ac6e-d7a6a4befae8 54868-2319 HUMAN PRESCRIPTION DRUG Leflunomide leflunomide TABLET, FILM COATED ORAL 20060710 ANDA ANDA077087 Physicians Total Care, Inc. LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] 54868-2323_4c3e2bbe-6a22-45ad-be50-3ba6281a6d07 54868-2323 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20110930 ANDA ANDA072838 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-2331_810f5846-8f33-4039-91de-88d2ffd5d822 54868-2331 HUMAN PRESCRIPTION DRUG LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 19940628 ANDA ANDA088299 Physicians Total Care, Inc. LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 54868-2335_60b11c09-e7ec-4f59-97b9-8a4237840578 54868-2335 HUMAN PRESCRIPTION DRUG Cozaar losartan potassium TABLET, FILM COATED ORAL 20030806 NDA NDA020386 Physicians Total Care, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-2337_a407b7b0-d214-4f75-9c48-669e3421d5c9 54868-2337 HUMAN OTC DRUG Colace docusate sodium CAPSULE ORAL 20111108 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. DOCUSATE SODIUM 100 mg/1 54868-2345_23fcc757-df53-458a-8ee1-20d1c78ee432 54868-2345 HUMAN OTC DRUG Milk of Magnesia MAGNESIUM HYDROXIDE SUSPENSION ORAL 19970619 OTC MONOGRAPH FINAL part334 Physicians Total Care, Inc. MAGNESIUM HYDROXIDE 1200 mg/15mL 54868-2349_c0f9e181-57bf-4442-bfc0-b6711f0e3a41 54868-2349 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950719 ANDA ANDA077877 Physicians Total Care, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-2350_55fc05f3-675b-4ab1-97f1-e6a3c1482245 54868-2350 HUMAN PRESCRIPTION DRUG Lotensin Benazepril Hydrochloride TABLET ORAL 20031104 NDA NDA019851 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-2351_55fc05f3-675b-4ab1-97f1-e6a3c1482245 54868-2351 HUMAN PRESCRIPTION DRUG Lotensin Benazepril Hydrochloride TABLET ORAL 19940323 NDA NDA019851 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-2352_55fc05f3-675b-4ab1-97f1-e6a3c1482245 54868-2352 HUMAN PRESCRIPTION DRUG Lotensin Benazepril Hydrochloride TABLET ORAL 19990224 NDA NDA019851 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-2353_853a8ce2-f42f-48bb-a39f-6562ef8ff151 54868-2353 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20040810 ANDA ANDA074256 Physicians Total Care, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 54868-2357_8426db88-8646-4230-9026-5a04c939621c 54868-2357 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20030204 ANDA ANDA085971 Physicians Total Care, Inc. AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 54868-2361_8cae852f-c80a-4a53-b263-537fb9e59f59 54868-2361 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19930324 ANDA ANDA084769 Physicians Total Care, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-2390_5d6870ab-c968-429a-9459-bc6f3fa17ea2 54868-2390 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20050406 ANDA ANDA065062 Physicians Total Care, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 54868-2391_5d6870ab-c968-429a-9459-bc6f3fa17ea2 54868-2391 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 19930930 ANDA ANDA065062 Physicians Total Care, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 54868-2399_587ea494-b2d2-40d6-8c4f-a74e435d23ae 54868-2399 HUMAN OTC DRUG Calcium Carbonate calcium carbon TABLET, CHEWABLE ORAL 19960423 OTC MONOGRAPH FINAL part331 Physicians Total Care, Inc. CALCIUM CARBONATE 500 mg/1 54868-2405_2400c707-fa24-452b-9002-333ae5901675 54868-2405 HUMAN OTC DRUG Aspirin EC aspirin TABLET, COATED ORAL 19930910 OTC MONOGRAPH FINAL part343 Physicians Total Care, Inc. ASPIRIN 325 mg/1 54868-2414_b77c9d7d-6c4c-4716-b724-72e15b3ea4d2 54868-2414 HUMAN PRESCRIPTION DRUG Ketoprofen ketoprofen CAPSULE ORAL 19970214 ANDA ANDA074035 Physicians Total Care, Inc. KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-2415_b77c9d7d-6c4c-4716-b724-72e15b3ea4d2 54868-2415 HUMAN PRESCRIPTION DRUG Ketoprofen ketoprofen CAPSULE ORAL 20050815 ANDA ANDA074035 Physicians Total Care, Inc. KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-2416_a516e403-1227-40ba-a414-7be1e2542242 54868-2416 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080937 Physicians Total Care, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] 54868-2433_8426db88-8646-4230-9026-5a04c939621c 54868-2433 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19990913 ANDA ANDA085967 Physicians Total Care, Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 54868-2434_8426db88-8646-4230-9026-5a04c939621c 54868-2434 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19950725 ANDA ANDA085970 Physicians Total Care, Inc. AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 54868-2438_bac8c65a-3126-4b90-ab5b-44e663ba4aad 54868-2438 HUMAN PRESCRIPTION DRUG AMOXAPINE amoxapine TABLET ORAL 20110512 ANDA ANDA072689 Physicians Total Care, Inc. AMOXAPINE 50 mg/1 Tricyclic Antidepressant [EPC] 54868-2440_2400c707-fa24-452b-9002-333ae5901675 54868-2440 HUMAN OTC DRUG Aspirin EC aspirin TABLET, COATED ORAL 20001130 OTC MONOGRAPH FINAL part343 Physicians Total Care, Inc. ASPIRIN 81 mg/1 54868-2451_b4447c1c-7a05-481c-aa6f-dec644f294df 54868-2451 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide SOLUTION TOPICAL 19930528 ANDA ANDA074799 Physicians Total Care, Inc. FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-2457_902526fc-a17b-481a-98bd-fe9f63a7742d 54868-2457 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20020822 OTC MONOGRAPH FINAL part343 Physicians Total Care, Inc. ACETAMINOPHEN 500 mg/1 54868-2462_b0faccb6-dd69-4b6d-9b67-5bc4865ee711 54868-2462 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, CHEWABLE ORAL 19950727 ANDA ANDA073524 Physicians Total Care, Inc. CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 54868-2463_8cae852f-c80a-4a53-b263-537fb9e59f59 54868-2463 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19930101 ANDA ANDA084768 Physicians Total Care, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-2464_ead4d3e2-ae16-4381-a78c-0c4bbd225b3c 54868-2464 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, FILM COATED ORAL 19730103 ANDA ANDA080439 Physicians Total Care, Inc. CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54868-2470_a0b3b753-bf21-4dfd-8973-6a41ae5e3ec2 54868-2470 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Nystatin and Triamcinolone OINTMENT TOPICAL 20050303 ANDA ANDA063305 Physicians Total Care, Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-2471_52c919c0-4f65-4ed0-9a6d-5fb44d32b39e 54868-2471 HUMAN OTC DRUG Miconazole Nitrate miconazole nitrate CREAM TOPICAL 20120320 OTC MONOGRAPH FINAL part333C Physicians Total Care, Inc. MICONAZOLE NITRATE 20 mg/g 54868-2472_e79e2829-414b-424d-b00b-9e61fe07eb84 54868-2472 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20031021 ANDA ANDA074880 Physicians Total Care, Inc. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 54868-2480_34af46e3-e2c0-4360-ae01-f3d30d388a99 54868-2480 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19930910 ANDA ANDA073556 Physicians Total Care, inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 54868-2481_34af46e3-e2c0-4360-ae01-f3d30d388a99 54868-2481 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20040225 ANDA ANDA073556 Physicians Total Care, inc. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 54868-2482_34af46e3-e2c0-4360-ae01-f3d30d388a99 54868-2482 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20081111 ANDA ANDA073554 Physicians Total Care, inc. NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 54868-2489_afff3544-c2ec-4412-96f7-01dad42e094b 54868-2489 HUMAN PRESCRIPTION DRUG Thiamine Hydrochloride Thiamine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010418 ANDA ANDA080556 Physicians Total Care, Inc. THIAMINE HYDROCHLORIDE 100 mg/mL 54868-2497_cc8e31d5-d163-400a-9ffe-7beeae5186fa 54868-2497 HUMAN OTC DRUG Bisacodyl Stimulant Laxative Bisacodyl TABLET, DELAYED RELEASE ORAL 20110922 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. BISACODYL 5 mg/1 54868-2522_9166ec18-da24-4f12-b446-dcf2dcc9d3ca 54868-2522 HUMAN PRESCRIPTION DRUG Neupogen filgrastim INJECTION, SOLUTION INTRAVENOUS 19940608 BLA BLA103353 Physicians Total Care, Inc. FILGRASTIM 300 ug/mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] 54868-2523_8bda2b6b-e72d-4955-9fa2-27af10454d34 54868-2523 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19940811 BLA BLA103234 Physicians Total Care, Inc. ERYTHROPOIETIN 10000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 54868-2539_11c40932-8c8f-4a48-8b1f-c0fa4c7dbaa7 54868-2539 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 19950810 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-2541_c9609f8f-7560-4da0-9519-4fabc761261c 54868-2541 HUMAN PRESCRIPTION DRUG Codeine Sulfate codeine sulfate TABLET ORAL 20090715 NDA NDA022402 Physicians Total Care, Inc. CODEINE SULFATE 60 mg/1 CII 54868-2552_21a83a08-cb04-448b-9897-83ec9538c9c2 54868-2552 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20030610 ANDA ANDA071608 Physicians Total Care, Inc. DOXEPIN HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 54868-2570_b525c891-0d0c-4063-b4a4-542b92d12bd8 54868-2570 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19990429 ANDA ANDA070278 Physicians Total Care, Inc. HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] 54868-2638_68dbd082-1862-4fc8-9b90-be362df5fc68 54868-2638 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20040603 NDA NDA021402 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-2655_d0858161-2ad5-447c-8e65-b63cec7e918f 54868-2655 HUMAN OTC DRUG PanOxyl benzoyl peroxide SOAP TOPICAL 20080331 OTC MONOGRAPH NOT FINAL part333D Physicians Total Care, Inc. BENZOYL PEROXIDE 5.65 g/1 54868-2656_d0858161-2ad5-447c-8e65-b63cec7e918f 54868-2656 HUMAN OTC DRUG PanOxyl benzoyl peroxide SOAP TOPICAL 20080331 OTC MONOGRAPH NOT FINAL part333D Physicians Total Care, Inc. BENZOYL PEROXIDE 11.3 g/1 54868-2679_abda8405-5e00-46b9-aa1e-742743e5a3e0 54868-2679 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19990219 ANDA ANDA073281 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-2683_3b12fe4e-f2ae-4555-b55d-822cd85e8d08 54868-2683 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19950502 ANDA ANDA073665 Physicians Total Care, Inc. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 54868-2685_1c3b841f-d9cb-40ed-ac92-387e2a79bacc 54868-2685 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium clorazepate dipotassium TABLET ORAL 20100827 ANDA ANDA071858 Physicians Total Care, Inc. CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-2702_89977ac0-499f-427b-9c6f-3600f6ac5319 54868-2702 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20041116 NDA NDA004782 Physicians Total Care, Inc. ESTROGENS, CONJUGATED .3 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 54868-2711_5f4d49a9-41e2-4177-8c12-9772dd905a51 54868-2711 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET, EXTENDED RELEASE ORAL 19950118 ANDA ANDA040009 Physicians Total Care, Inc. ISOSORBIDE DINITRATE 40 mg/1 54868-2742_01e5c83f-f5a7-413f-953b-4cf3a41135bf 54868-2742 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE DENTAL 20030903 ANDA ANDA070730 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-2746_3457b3b5-976d-4240-bfad-e448294ec9cb 54868-2746 HUMAN OTC DRUG Humalog 70/30 Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 19941228 NDA NDA019717 Physicians Total Care, Inc. INSULIN HUMAN 100 [iU]/mL 54868-2762_94248b05-cdeb-47d3-b656-d6a8a2864ba9 54868-2762 HUMAN PRESCRIPTION DRUG Ritalin methylphenidate hydrochloride TABLET ORAL 20000310 NDA NDA010187 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-2782_493a8c42-16da-4710-9357-a46cd501377f 54868-2782 HUMAN PRESCRIPTION DRUG Ciloxan ciprofloxacin hydrochloride SOLUTION OPHTHALMIC 19950710 NDA NDA019992 Physicians Total Care, Inc. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54868-2803_fb93a612-3a73-4e60-8567-4c971c67804e 54868-2803 HUMAN PRESCRIPTION DRUG Transderm Scop scopolamine PATCH, EXTENDED RELEASE TRANSDERMAL 20071002 NDA NDA017874 Physicians Total Care, Inc. SCOPOLAMINE 1 mg/3d Anticholinergic [EPC],Cholinergic Antagonists [MoA] 54868-2804_0f1ad27b-69a7-49e2-bab8-c520474fec26 54868-2804 HUMAN PRESCRIPTION DRUG EpiPen epinephrine INJECTION INTRAMUSCULAR 20030617 NDA NDA019430 Physicians Total Care, Inc. EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 54868-2817_53d395c2-3b12-4506-8400-6229df831c89 54868-2817 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20090422 ANDA ANDA086841 Physicians Total Care, Inc. DAPSONE 25 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] 54868-2829_78562b23-7160-4e69-98ca-a2e2c5e5202a 54868-2829 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone GEL TOPICAL 20080229 ANDA ANDA074904 Physicians Total Care, Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-2834_55592f54-580b-4049-bbab-d82e7c3255a4 54868-2834 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19941209 ANDA ANDA073607 Physicians Total Care, Inc. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 54868-2835_34af46e3-e2c0-4360-ae01-f3d30d388a99 54868-2835 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20090609 ANDA ANDA073554 Physicians Total Care, inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 54868-2840_776a59d7-9876-49e5-96c8-fe45230c6e49 54868-2840 HUMAN PRESCRIPTION DRUG Ery-Tab erythromycin TABLET, DELAYED RELEASE ORAL 20040630 ANDA ANDA062298 Physicians Total Care, Inc. ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54868-2841_d2710544-16ee-4e77-9912-5e41355a9d30 54868-2841 HUMAN PRESCRIPTION DRUG Mycobutin rifabutin CAPSULE ORAL 19950315 NDA NDA050689 Physicians Total Care, Inc. RIFABUTIN 150 mg/1 Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient] 54868-2844_b0edb786-44c1-43ea-afc0-78df4970ce86 54868-2844 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19970326 ANDA ANDA040863 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54868-2847_8e359d73-d777-49d9-af50-724344f1a879 54868-2847 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide qinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20060803 ANDA ANDA078211 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 20 mg/1; nmol/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-2860_27e21629-a817-4252-aa59-275b035ad251 54868-2860 HUMAN OTC DRUG Gas Relief Simethicone TABLET, CHEWABLE ORAL 19950517 OTC MONOGRAPH FINAL part332 Physicians Total Care, Inc. DIMETHICONE 80 mg/1 54868-2861_2834ef65-c3dc-40e8-a99f-998aa4706e81 54868-2861 HUMAN PRESCRIPTION DRUG Alclometasone Dipropionate Alclometasone Dipropionate CREAM TOPICAL 20090623 ANDA ANDA079061 Physicians Total Care, Inc. ALCLOMETASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-2866_55592f54-580b-4049-bbab-d82e7c3255a4 54868-2866 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19930928 ANDA ANDA073618 Physicians Total Care, Inc. CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 54868-2875_4c539f04-059e-485a-8a8e-038ccb474b2b 54868-2875 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate SOLUTION TOPICAL 20020111 ANDA ANDA064159 Physicians Total Care, Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 54868-2876_dc8b1f98-70fd-475e-8b4b-84bc50a072e9 54868-2876 HUMAN PRESCRIPTION DRUG Myambutol Ethambutol hydrochloride TABLET ORAL 20070810 NDA NDA016320 Physicians Total Care, Inc. ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] 54868-2877_ea6e8605-97f4-4667-8a19-2fb05b42faf1 54868-2877 HUMAN OTC DRUG Vitamin A and Vitamin D PETROLATUM OINTMENT TOPICAL 20060719 OTC MONOGRAPH FINAL part347 Physicians Total Care, Inc. PETROLATUM 929.3 mg/g 54868-2887_df7bbf34-0dc4-41d3-b9be-22ad75bcbbe5 54868-2887 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP ORAL 19941013 ANDA ANDA074749 Physicians Total Care, Inc. ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 54868-2892_5e24193d-bc31-4e7d-b5a6-2815218cffd6 54868-2892 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20000209 ANDA ANDA087479 Physicians Total Care, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 54868-2893_b5f46d0d-6971-4954-96ca-01bd0faa52eb 54868-2893 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070917 ANDA ANDA086242 Physicians Total Care, Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 54868-2894_e150632a-d379-4a7a-9fd9-b4cb34fa3179 54868-2894 HUMAN PRESCRIPTION DRUG Fortamet metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20100218 NDA NDA021574 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-2898_2d8ef7bd-561e-4ed3-8ccb-07a92be6f964 54868-2898 HUMAN OTC DRUG Peptic Relief original strength Bismuth subsalicylate LIQUID ORAL 20081211 OTC MONOGRAPH FINAL part335 Physicians Total Care, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL 54868-2908_56ca3fba-210b-4cb8-933d-cd7189b55f58 54868-2908 HUMAN PRESCRIPTION DRUG LORTAB Hydrocodone Bitartrate and Acetaminophen SYRUP ORAL 19940816 ANDA ANDA040520 Physicians Total Care, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 54868-2913_9775e04f-8420-43ac-9a43-17d6bc263167 54868-2913 HUMAN PRESCRIPTION DRUG Methylprednisolone methylprednisolone TABLET ORAL 20091015 ANDA ANDA088497 Physicians Total Care, Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-2923_26d4b5e5-c715-4c55-b2fd-a51f9a3b1f5e 54868-2923 HUMAN OTC DRUG Glycerin Adult Glycerin SUPPOSITORY RECTAL 20101209 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. GLYCERIN 2 g/1 54868-2929_0d231e91-00f1-482d-aa82-01031de593af 54868-2929 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20050317 ANDA ANDA074046 Physicians Total Care, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-2930_0d231e91-00f1-482d-aa82-01031de593af 54868-2930 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20071026 ANDA ANDA074046 Physicians Total Care, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-2932_5939bdd8-49f6-4f94-8781-09992a046b69 54868-2932 HUMAN PRESCRIPTION DRUG Pristiq Extended-Release desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20080501 NDA NDA021992 Physicians Total Care, Inc. DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 54868-2971_774954ec-cef7-40a1-9eec-643fba420da2 54868-2971 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Neomycin and Polymyxin B Sulfates and Bacitracin Zinc OINTMENT OPHTHALMIC 19940325 ANDA ANDA064064 Physicians Total Care, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 10000 [USP'U]/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] 54868-2972_676d3ac0-adfe-40ef-861b-c19680ab9ba3 54868-2972 HUMAN PRESCRIPTION DRUG TUBERSOL Tuberculin Purified Protein Derivative INJECTION, SOLUTION INTRADERMAL 19560815 BLA BLA103941 Physicians Total Care, Inc. TUBERCULIN PURIFIED PROTEIN DERIVATIVE 5 [iU]/.1mL Skin Test Antigen [EPC],Tuberculosis Skin Test [EPC],Cell-mediated Immunity [PE],Antigens, Bacterial [Chemical/Ingredient] 54868-2974_e6ce1d8c-e996-4b57-b6b3-3f312b449886 54868-2974 HUMAN PRESCRIPTION DRUG Methylphenidate methylphenidate hydrochloride TABLET ORAL 20071016 ANDA ANDA040220 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-2976_7b000f3a-baee-450d-ad32-851dbce53b05 54868-2976 HUMAN PRESCRIPTION DRUG PAXIL paroxetine hydrochloride TABLET, FILM COATED ORAL 20060918 NDA NDA020031 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-2984_3af42a6e-4178-482c-9e96-647e289d325a 54868-2984 HUMAN PRESCRIPTION DRUG MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate TABLET ORAL 19950424 NDA AUTHORIZED GENERIC NDA011839 Physicians Total Care, Inc. MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54868-2985_3af42a6e-4178-482c-9e96-647e289d325a 54868-2985 HUMAN PRESCRIPTION DRUG MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate TABLET ORAL 19950919 NDA AUTHORIZED GENERIC NDA011839 Physicians Total Care, Inc. MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54868-2989_01773720-eb77-4c73-880c-a727561fafc7 54868-2989 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 19940105 ANDA ANDA077739 Physicians Total Care, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-2990_01773720-eb77-4c73-880c-a727561fafc7 54868-2990 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 19941129 ANDA ANDA077739 Physicians Total Care, Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-2994_ce005228-bed3-4940-831b-c7f8b8256d9f 54868-2994 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate OINTMENT TOPICAL 19970502 ANDA ANDA018865 Physicians Total Care, Inc. BETAMETHASONE VALERATE 1 mg/g 54868-2996_b1e1c690-2ad8-453c-86c0-858cf3502952 54868-2996 HUMAN PRESCRIPTION DRUG METHAZOLAMIDE methazolamide TABLET ORAL 20061212 ANDA ANDA040036 Physicians Total Care, Inc. METHAZOLAMIDE 50 mg/1 54868-3004_6630c8a2-8c01-4ae7-a48d-0bf6ffd5b22a 54868-3004 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 19940426 ANDA ANDA075797 Physicians Total Care, Inc. TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 54868-3005_0d231e91-00f1-482d-aa82-01031de593af 54868-3005 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20060913 ANDA ANDA074046 Physicians Total Care, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-3006_b4deba09-9747-4145-bb8c-956ce26560ad 54868-3006 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20090417 ANDA ANDA072235 Physicians Total Care, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 54868-3023_bb001c15-9f5c-454e-b12d-e8664b16f80b 54868-3023 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide GEL TOPICAL 20040520 ANDA ANDA072537 Physicians Total Care, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-3026_cb0651c6-180a-435f-a124-8e4d33c8a5ea 54868-3026 HUMAN OTC DRUG Natural Fiber Powder Smooth Texture PSYLLIUM HUSK GRANULE ORAL 20110331 OTC MONOGRAPH FINAL part334 Physicians Total Care, Inc. PSYLLIUM HUSK 3.4 g/100g 54868-3041_fed9b9ba-de86-4c2e-a424-4d7db8b47bf3 54868-3041 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 19940623 ANDA ANDA073193 Physicians Total Care, Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-3043_f379ec02-a978-4c53-a036-564f250ed3f8 54868-3043 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 19940114 ANDA ANDA078314 Physicians Total Care, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-3046_759ff775-6dc9-46c3-8a45-853f619c19ea 54868-3046 HUMAN OTC DRUG Hibiclens Chlorhexidine gluconate SOLUTION TOPICAL 20041117 NDA NDA017768 Physicians Total Care, Inc. CHLORHEXIDINE GLUCONATE 213 g/1000mL 54868-3049_1322c2db-3238-4fbf-95b3-6e0b0c8ae7f1 54868-3049 HUMAN PRESCRIPTION DRUG Diflunisal Diflunisal TABLET, FILM COATED ORAL 20090721 ANDA ANDA073673 Physicians Total Care, Inc. DIFLUNISAL 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-3050_9166ec18-da24-4f12-b446-dcf2dcc9d3ca 54868-3050 HUMAN PRESCRIPTION DRUG Neupogen filgrastim INJECTION, SOLUTION INTRAVENOUS 20060814 BLA BLA103353 Physicians Total Care, Inc. FILGRASTIM 480 ug/.8mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] 54868-3059_278a4c28-41eb-4894-9275-a793d1805ba0 54868-3059 HUMAN PRESCRIPTION DRUG Clomiphene Citrate Clomiphene Citrate TABLET ORAL 19960822 ANDA ANDA075528 Physicians Total Care, Inc. CLOMIPHENE CITRATE 50 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 54868-3062_59a95728-34a6-4741-8807-cba7da17e1ab 54868-3062 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070924 ANDA ANDA078332 Physicians Total Care, Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 54868-3064_3b12fe4e-f2ae-4555-b55d-822cd85e8d08 54868-3064 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 20050505 ANDA ANDA073665 Physicians Total Care, Inc. ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 54868-3068_e58a7f34-4791-4ebb-b13a-75caf23f0f8d 54868-3068 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20030807 ANDA ANDA072640 Physicians Total Care, Inc. CLOTRIMAZOLE 10 mg/g 54868-3071_a830869a-cacf-4e78-a721-42d550944704 54868-3071 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20090511 NDA NDA018074 Physicians Total Care, Inc. PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 54868-3086_66ea5793-f691-4217-9a37-39690a7a3f69 54868-3086 HUMAN PRESCRIPTION DRUG Multaq Dronedarone TABLET, FILM COATED ORAL 20100223 NDA NDA022425 Physicians Total Care, Inc. DRONEDARONE 400 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 54868-3089_6c1f2ad3-c872-440f-99d5-8201a5af54a8 54868-3089 HUMAN PRESCRIPTION DRUG Dextrose Dextrose INJECTION, SOLUTION INTRAVENOUS 20061211 NDA NDA019445 Physicians Total Care, Inc. DEXTROSE MONOHYDRATE 25 g/50mL 54868-3097_740bcab1-830a-46c1-afa8-c71191d1b9b7 54868-3097 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide LOTION TOPICAL 20050126 ANDA ANDA088451 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-3101_fea217d1-9c40-49b9-9731-0227fcbf74b7 54868-3101 HUMAN PRESCRIPTION DRUG Lactulose lactulose SOLUTION ORAL 20040419 ANDA ANDA074623 Physicians Total Care, Inc. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 54868-3103_e5f3b0c9-1c83-47b1-8de0-375ea9719d22 54868-3103 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20001114 NDA AUTHORIZED GENERIC NDA020401 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-3105_48ab8ad9-6a35-4696-a79b-7a8aed5f3c5a 54868-3105 HUMAN PRESCRIPTION DRUG Amoxicillin amoxicillin TABLET, CHEWABLE ORAL 20040601 ANDA ANDA065021 Physicians Total Care, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54868-3107_db05df82-8297-4bea-9036-dc5d651cac72 54868-3107 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20031029 ANDA ANDA064076 Physicians Total Care, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54868-3109_db05df82-8297-4bea-9036-dc5d651cac72 54868-3109 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19940930 ANDA ANDA064076 Physicians Total Care, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54868-3110_51046537-1147-43b7-9b0a-140919c1453b 54868-3110 HUMAN PRESCRIPTION DRUG METROGEL metronidazole GEL VAGINAL 19941219 NDA NDA020208 Physicians Total Care, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 54868-3112_abe66794-692f-4b30-86d3-bdfc64f4f8f1 54868-3112 HUMAN PRESCRIPTION DRUG Prochlorperazine Prochlorperazine SUPPOSITORY RECTAL 20010720 ANDA ANDA040058 Physicians Total Care, Inc. PROCHLORPERAZINE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54868-3113_968da774-da92-4eed-bfb1-ae2a68b2d94e 54868-3113 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 20110322 ANDA ANDA064082 Physicians Total Care, Inc. AMPICILLIN TRIHYDRATE 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54868-3114_210798f9-c1d1-4c6b-bfe9-06c02c801234 54868-3114 HUMAN PRESCRIPTION DRUG Estropipate estropipate TABLET ORAL 20030321 ANDA ANDA081213 Physicians Total Care, Inc. ESTROPIPATE .75 mg/1 54868-3115_5192b19b-5bd1-4f62-9cad-b120de7dbb74 54868-3115 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20060530 ANDA ANDA089771 Physicians Total Care, Inc. NITROGLYCERIN 2.5 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 54868-3129_62e47df3-814e-499f-b949-843e852b358d 54868-3129 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION OPHTHALMIC 20050620 ANDA ANDA088771 Physicians Total Care, Inc. DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-3134_d89a9f8c-c600-436b-97e7-ed8c54d42aff 54868-3134 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 20090909 NDA NDA016694 Physicians Total Care, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 54868-3137_69c62db2-25f0-4f7e-937d-8a52e457ee49 54868-3137 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET ORAL 20080606 ANDA ANDA077290 Physicians Total Care, Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-3155_5264120b-3fa4-42c6-a517-1d1abc71421a 54868-3155 HUMAN OTC DRUG Dulcolax Bisacodyl SUPPOSITORY RECTAL 20110317 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. BISACODYL 10 mg/1 54868-3157_537cd838-05f2-44f4-aeb2-89c42f153e3c 54868-3157 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20050621 ANDA ANDA087916 Physicians Total Care, Inc DEXAMETHASONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-3165_e387fd18-7c90-431b-8e9b-b381edb43c49 54868-3165 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, FILM COATED ORAL 20040920 ANDA ANDA078273 Physicians Total Care, Inc. HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-3169_77fd8181-dd74-490f-9eab-e6c47573309b 54868-3169 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19940801 ANDA ANDA062031 Physicians Total Care, Inc. DOXYCYCLINE HYCLATE 50 mg/1 54868-3180_d88cd7d7-60a1-48df-b426-40b37fa732f0 54868-3180 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate INJECTION SUBCUTANEOUS 19950126 NDA NDA020080 Physicians Total Care, Inc. SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 54868-3191_faad3ce3-e3a8-415b-9396-d22c840fab0d 54868-3191 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080107 NDA NDA022207 Physicians Total Care, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-3216_3267cd9b-c7c6-4b6d-8e67-1e656972d5d0 54868-3216 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride SOLUTION ORAL 20050223 ANDA ANDA075060 Physicians Total Care, Inc. AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 54868-3230_2ed9b59c-40be-4140-aa8e-1584dcd09329 54868-3230 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19940411 NDA NDA021171 Physicians Total Care, Inc. MEPERIDINE HYDROCHLORIDE 50 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-3250_a5f505d5-486e-446c-bc02-ac4f482bf5b7 54868-3250 HUMAN PRESCRIPTION DRUG Neomycin, Polymyxin B Sulfates and Hydrocortisone Neomycin, Polymyxin B Sulfates and Hydrocortisone SUSPENSION OPHTHALMIC 19940407 ANDA ANDA062423 Physicians Total Care, Inc. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 100; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-3257_8b910c5e-691b-492d-95df-bb01fd6b0c4f 54868-3257 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 20100114 ANDA ANDA074172 Physicians Total Care, Inc. NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-3265_49f0ce6f-5305-41c2-8afe-eed1870459b8 54868-3265 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19940426 ANDA ANDA076257 Physicians Total Care, Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-3266_49f0ce6f-5305-41c2-8afe-eed1870459b8 54868-3266 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19940826 ANDA ANDA076257 Physicians Total Care, Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-3267_e20a1904-ff41-4b58-83b3-74318c3a64ee 54868-3267 HUMAN OTC DRUG Acetaminophen infants Acetaminophen SUSPENSION/ DROPS ORAL 19940513 OTC MONOGRAPH NOT FINAL part343 Physicians Total Care, Inc. ACETAMINOPHEN 80 mg/.8mL 54868-3269_5b3bcf88-28c0-4266-b26e-9a5156bb7a9f 54868-3269 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 19790822 OTC MONOGRAPH FINAL part333B Physicians Total Care, Inc. BACITRACIN 500 [USP'U]/g 54868-3280_66df8564-8239-4078-ba9a-35a11cfb36e7 54868-3280 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate OINTMENT TOPICAL 19940427 ANDA ANDA019141 Physicians Total Care, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-3283_ff09d876-3fc3-4826-b04b-f600a4cfba83 54868-3283 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, FILM COATED ORAL 20001205 NDA NDA020829 Physicians Total Care, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 54868-3284_86025f14-dda5-4c28-bbe1-bafa3f511119 54868-3284 HUMAN PRESCRIPTION DRUG Desonide Desonide CREAM TOPICAL 20060411 NDA NDA017010 Physicians Total Care, Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-3287_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-3287 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20090415 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-3300_5651bc48-1227-4ca9-aaf9-805771c27090 54868-3300 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960115 ANDA ANDA074587 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-3310_d67caab0-2ebd-4d80-a415-2e329fb5a34e 54868-3310 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 20020415 ANDA ANDA072733 Physicians Total Care, Inc. LEUCOVORIN CALCIUM 5 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 54868-3314_13f68ac1-1bb6-45d1-acee-124b56a1fae8 54868-3314 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 19940622 ANDA ANDA074424 Physicians Total Care, Inc. CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 54868-3315_13f68ac1-1bb6-45d1-acee-124b56a1fae8 54868-3315 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 19940725 ANDA ANDA074424 Physicians Total Care, Inc. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 54868-3316_13f68ac1-1bb6-45d1-acee-124b56a1fae8 54868-3316 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 19940523 ANDA ANDA074424 Physicians Total Care, Inc. CIMETIDINE 800 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 54868-3318_df0a1559-aa16-4126-b4c1-fd51aa19c2c7 54868-3318 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19940726 ANDA ANDA074223 Physicians Total Care, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-3319_df0a1559-aa16-4126-b4c1-fd51aa19c2c7 54868-3319 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19941118 ANDA ANDA074223 Physicians Total Care, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-3327_b2688fe1-f2f1-4c67-8420-0647a0ff0694 54868-3327 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051020 ANDA ANDA076802 Physicians Total Care, Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-3329_ef0d7cf5-ed4e-47ea-8c4c-8426e03e7c82 54868-3329 HUMAN PRESCRIPTION DRUG LESCOL fluvastatin sodium CAPSULE ORAL 19940610 NDA NDA020261 Physicians Total Care, Inc. FLUVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-3334_71c99c7c-76eb-425c-83d9-880c78c935a6 54868-3334 HUMAN PRESCRIPTION DRUG Glucotrol XL glipizide TABLET, EXTENDED RELEASE ORAL 19940930 NDA NDA020329 Physicians Total Care, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-3335_71c99c7c-76eb-425c-83d9-880c78c935a6 54868-3335 HUMAN PRESCRIPTION DRUG Glucotrol XL glipizide TABLET, EXTENDED RELEASE ORAL 19940801 NDA NDA020329 Physicians Total Care, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-3348_3737b5dd-6816-4df6-ad81-761eae67918e 54868-3348 HUMAN PRESCRIPTION DRUG Depo-Provera medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19950113 NDA NDA012541 Physicians Total Care, Inc. MEDROXYPROGESTERONE ACETATE 400 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54868-3362_805932c3-0a3a-4eac-a6ab-9b8cca1929bd 54868-3362 HUMAN PRESCRIPTION DRUG Flurbiprofen flurbiprofen TABLET, FILM COATED ORAL 19970224 ANDA ANDA074358 Physicians Total Care, Inc. FLURBIPROFEN 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-3363_46bb62bb-de08-4317-8dd3-b5c911b8e3cc 54868-3363 HUMAN PRESCRIPTION DRUG Levobunolol Hydrochloride Levobunolol Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19950223 ANDA ANDA074326 Physicians Total Care, Inc. LEVOBUNOLOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-3377_b2688fe1-f2f1-4c67-8420-0647a0ff0694 54868-3377 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051019 ANDA ANDA076802 Physicians Total Care, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-3384_035934ee-0466-4e9f-b15d-1eba7aa748d2 54868-3384 HUMAN PRESCRIPTION DRUG Biaxin Clarithromycin GRANULE, FOR SUSPENSION ORAL 20070501 NDA NDA050698 Physicians Total Care, Inc. CLARITHROMYCIN 250 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 54868-3388_11c40932-8c8f-4a48-8b1f-c0fa4c7dbaa7 54868-3388 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20050404 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-3390_54642793-18db-4fca-9056-a2ca5a740e59 54868-3390 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 19941006 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-3399_d975e88b-476c-463b-9600-3fbcdb0e86f2 54868-3399 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20001121 NDA NDA009218 Physicians Total Care, Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54868-3405_b4deba09-9747-4145-bb8c-956ce26560ad 54868-3405 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100305 ANDA ANDA072234 Physicians Total Care, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 54868-3407_1c40dbf2-4ce1-47e0-9425-a246e9fdc9bc 54868-3407 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19941019 ANDA ANDA074543 Physicians Total Care, Inc. ALBUTEROL SULFATE 5 mg/mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 54868-3408_a87f96f5-e6c3-40c5-b587-4d4fc917c46c 54868-3408 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19840626 NDA NDA019117 Physicians Total Care, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-3423_fde0098f-69a8-4e16-8c8e-b73786aaa9e5 54868-3423 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20100119 ANDA ANDA077519 Physicians Total Care, Inc. BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-3426_49f0ce6f-5305-41c2-8afe-eed1870459b8 54868-3426 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19941118 ANDA ANDA076257 Physicians Total Care, Inc. GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-3435_bb001c15-9f5c-454e-b12d-e8664b16f80b 54868-3435 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide OINTMENT TOPICAL 19941122 ANDA ANDA073481 Physicians Total Care, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-3437_d89a9f8c-c600-436b-97e7-ed8c54d42aff 54868-3437 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 20090908 NDA NDA016964 Physicians Total Care, Inc. BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 54868-3438_d89a9f8c-c600-436b-97e7-ed8c54d42aff 54868-3438 HUMAN PRESCRIPTION DRUG Marcaine with Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION 20100506 NDA NDA016964 Physicians Total Care, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; .0091 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 54868-3439_d89a9f8c-c600-436b-97e7-ed8c54d42aff 54868-3439 HUMAN PRESCRIPTION DRUG Marcaine with Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION 20100510 NDA NDA016964 Physicians Total Care, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 5; .0091 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 54868-3454_d0a1c04b-91eb-4751-8e42-89e3c4d323d6 54868-3454 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 19941216 ANDA ANDA086428 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-3457_943adc58-3c44-4b5e-b7da-20d4b550a65b 54868-3457 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 19951227 ANDA ANDA040597 Physicians Total Care, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 54868-3465_e4403738-ddcb-4f9b-80c3-2e1ac9d61bde 54868-3465 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 20021016 ANDA ANDA071344 Physicians Total Care, Inc. MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 54868-3467_e4403738-ddcb-4f9b-80c3-2e1ac9d61bde 54868-3467 HUMAN PRESCRIPTION DRUG MINOXIDIL Minoxidil TABLET ORAL 19960913 ANDA ANDA071345 Physicians Total Care, Inc. MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 54868-3474_f8f7bdaf-47bb-43bc-8696-a6b844e21933 54868-3474 HUMAN OTC DRUG Novolin 70/30 Human Insulin INJECTION, SUSPENSION SUBCUTANEOUS 19950111 NDA NDA019991 Physicians Total Care, Inc. INSULIN HUMAN 100 [USP'U]/mL 54868-3478_c1c22706-36a7-47b4-97e4-3ad4c67ea753 54868-3478 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor CAPSULE ORAL 19960124 ANDA ANDA064156 Physicians Total Care, Inc. CEFACLOR 250 mg/1 54868-3511_c1c22706-36a7-47b4-97e4-3ad4c67ea753 54868-3511 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor CAPSULE ORAL 19950405 ANDA ANDA064156 Physicians Total Care, Inc. CEFACLOR 500 mg/1 54868-3524_b11256fa-aab4-452f-83e4-4447fdbd63e7 54868-3524 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate gentamicin sulfate CREAM TOPICAL 19950512 ANDA ANDA062307 Physicians Total Care, Inc. GENTAMICIN SULFATE 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 54868-3526_7b000f3a-baee-450d-ad32-851dbce53b05 54868-3526 HUMAN PRESCRIPTION DRUG PAXIL paroxetine hydrochloride TABLET, FILM COATED ORAL 19960710 NDA NDA020031 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-3533_21a83a08-cb04-448b-9897-83ec9538c9c2 54868-3533 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20070801 ANDA ANDA071669 Physicians Total Care, Inc. DOXEPIN HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 54868-3550_fde0098f-69a8-4e16-8c8e-b73786aaa9e5 54868-3550 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20090204 ANDA ANDA077519 Physicians Total Care, Inc. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-3559_cae8fb46-3120-4ddb-9cbf-649e5cae5a73 54868-3559 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride INJECTION INTRAMUSCULAR 20100304 ANDA ANDA080455 Physicians Total Care, Inc. MEPERIDINE HYDROCHLORIDE 50 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-3566_d2cde812-4f5e-41ce-9ee2-e144b36a4e5f 54868-3566 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070110 ANDA ANDA074300 Physicians Total Care, Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-3584_23a906da-21fa-4ac7-9097-95af783b7723 54868-3584 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 19970502 ANDA ANDA074220 Physicians Total Care, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-3618_85571ab6-b0f5-4f49-b883-499ec60aaaed 54868-3618 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20070810 ANDA ANDA040530 Physicians Total Care, Inc. TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 54868-3619_5ace7bf4-ae3d-4cc5-b5b6-a171d26d82a2 54868-3619 HUMAN OTC DRUG Humulin R Insulin human INJECTION, SOLUTION SUBCUTANEOUS 19950727 NDA NDA018780 Physicians Total Care, Inc. INSULIN HUMAN 100 [iU]/mL 54868-3632_bd26a0a2-2f4c-47ae-948f-e6868ac91132 54868-3632 HUMAN PRESCRIPTION DRUG LITHIUM CARBONATE Lithium Carbonate CAPSULE ORAL 20051205 ANDA ANDA090702 Physicians Total Care, Inc. LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] 54868-3648_db900408-b413-4795-9749-e75a8a53d1c5 54868-3648 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 19950815 ANDA ANDA065212 Physicians Total Care, Inc. AZITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54868-3655_10e3f643-f415-4646-bb59-60ca369f9bb2 54868-3655 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20100304 NDA NDA021977 Physicians Total Care, Inc. LISDEXAMFETAMINE DIMESYLATE 70 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-3659_76eaad99-62c9-4c09-b22e-36e7e10a1265 54868-3659 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19951116 ANDA ANDA074376 Physicians Total Care, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-3669_f1bd3dd6-7d12-48fa-87a8-820762c54f27 54868-3669 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20060810 ANDA ANDA040615 Physicians Total Care, Inc. TESTOSTERONE CYPIONATE 100 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 54868-3671_e1f4e093-cf3f-4ce0-ba22-3fc5f3c4251c 54868-3671 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20041217 ANDA ANDA075604 Physicians Total Care, Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 54868-3690_55fc05f3-675b-4ab1-97f1-e6a3c1482245 54868-3690 HUMAN PRESCRIPTION DRUG Lotensin Benazepril Hydrochloride TABLET ORAL 19961230 NDA NDA019851 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-3693_4062960e-f215-4ffd-a79e-241c34a67746 54868-3693 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 19951201 NDA NDA020564 Physicians Total Care, Inc. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 54868-3695_3d6a40a1-b103-4636-b143-6119ff16803a 54868-3695 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970227 ANDA ANDA062801 Physicians Total Care, Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 54868-3698_58d0c66a-8d8b-432c-ada7-dac055230fce 54868-3698 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate OINTMENT TOPICAL 20050302 ANDA ANDA074248 Physicians Total Care, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-3713_8459e88b-78ab-4eb8-80ed-e56ada9535ee 54868-3713 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION OPHTHALMIC 19960126 ANDA ANDA074261 Physicians Total Care, Inc. TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-3714_8459e88b-78ab-4eb8-80ed-e56ada9535ee 54868-3714 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION OPHTHALMIC 19950126 ANDA ANDA074262 Physicians Total Care, Inc. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-3722_e568b860-2272-4a94-8f4d-095cda3be647 54868-3722 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 19980324 ANDA ANDA077789 Physicians Total Care, Inc. CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] 54868-3724_fa5809cd-a0d0-4ff6-a902-cb8a2e1c60f6 54868-3724 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960425 ANDA ANDA074505 Physicians Total Care, Inc. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-3725_fa5809cd-a0d0-4ff6-a902-cb8a2e1c60f6 54868-3725 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960805 ANDA ANDA074505 Physicians Total Care, Inc. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-3726_60b11c09-e7ec-4f59-97b9-8a4237840578 54868-3726 HUMAN PRESCRIPTION DRUG Cozaar losartan potassium TABLET, FILM COATED ORAL 19960401 NDA NDA020386 Physicians Total Care, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-3732_9f789e65-2050-42ea-9b06-6adee341edd6 54868-3732 HUMAN PRESCRIPTION DRUG MEBENDAZOLE mebendazole TABLET, CHEWABLE ORAL 19960404 ANDA ANDA073580 Physicians Total Care, Inc. MEBENDAZOLE 100 mg/1 Antihelminthic [EPC] 54868-3735_eee48d18-28a7-4ac9-92b8-3e6f738223f3 54868-3735 HUMAN PRESCRIPTION DRUG Carafate Sucralfate SUSPENSION ORAL 19960312 NDA NDA019183 Physicians Total Care, Inc. SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 54868-3742_c0fa3fe4-2403-4a8d-a41a-d812a552d0b8 54868-3742 HUMAN PRESCRIPTION DRUG Cefadroxil cefadroxil hemihydrate CAPSULE ORAL 19960423 ANDA ANDA065015 Physicians Total Care, Inc. CEFADROXIL HEMIHYDRATE 500 mg/1 54868-3757_02247f29-7afe-46dd-a5f6-ef8f8eeec7a3 54868-3757 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate SOLUTION TOPICAL 20060330 ANDA ANDA075919 Physicians Total Care, Inc. MOMETASONE FUROATE 1 mg/mL 54868-3764_39d05358-adcf-48a9-ad87-39e05d1fe577 54868-3764 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20090216 ANDA ANDA074700 Physicians Total Care, Inc. BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 54868-3765_39d05358-adcf-48a9-ad87-39e05d1fe577 54868-3765 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20001129 ANDA ANDA074700 Physicians Total Care, Inc. BUMETANIDE .5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 54868-3781_fe4870ed-c2d6-45f1-b69c-959667ab2e83 54868-3781 HUMAN OTC DRUG Minoxidil minoxidil SOLUTION TOPICAL 19960604 ANDA ANDA074588 Physicians Total Care, Inc. MINOXIDIL 2 g/100mL 54868-3799_28327f6d-9226-4266-bfb2-7a89715a978b 54868-3799 HUMAN PRESCRIPTION DRUG Prempro conjugated estrogens and medroxyprogesterone acetate TABLET, SUGAR COATED ORAL 19960620 NDA NDA020527 Physicians Total Care, Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .625; 2.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54868-3800_cd8751c0-81b3-4fc4-84bf-1f84e0a827b5 54868-3800 HUMAN PRESCRIPTION DRUG Premphase conjugated estrogens and medroxyprogesterone acetate KIT 20050708 ANDA ANDA075796 Physicians Total Care, Inc. 54868-3801_53d395c2-3b12-4506-8400-6229df831c89 54868-3801 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20051216 ANDA ANDA086842 Physicians Total Care, Inc. DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] 54868-3821_17a5d335-2026-40d5-8c4d-b6522c0dc1e4 54868-3821 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 19960709 ANDA ANDA040766 Physicians Total Care, Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 54868-3826_1856dd9e-177f-42a2-99f5-4ca56c727f27 54868-3826 HUMAN PRESCRIPTION DRUG Methotrexate Sodium methotrexate sodium TABLET ORAL 20071205 ANDA ANDA081099 Physicians Total Care, Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 54868-3832_185df2c5-c212-46fc-9697-f1185fa23ff9 54868-3832 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20021024 OTC MONOGRAPH FINAL part343 Physicians Total Care, Inc. ACETAMINOPHEN 500 mg/1 54868-3835_f1bacd71-d3dc-44ac-aa69-ea49bbf77be5 54868-3835 HUMAN PRESCRIPTION DRUG Demadex Torsemide TABLET ORAL 20001128 NDA NDA020136 Physicians Total Care, Inc. TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 54868-3837_76eaad99-62c9-4c09-b22e-36e7e10a1265 54868-3837 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19970210 ANDA ANDA074394 Physicians Total Care, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-3849_05cb0c12-5291-438e-93fd-86aa7cc81611 54868-3849 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 19960829 NDA NDA021301 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-3854_8631cd71-b034-4a99-9683-f13a37940462 54868-3854 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20050516 ANDA ANDA077856 Physicians Total Care, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-3855_8631cd71-b034-4a99-9683-f13a37940462 54868-3855 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20030925 ANDA ANDA077856 Physicians Total Care, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-3857_f7eed7fa-4c6f-4dfc-836d-4b8333aee0d3 54868-3857 HUMAN PRESCRIPTION DRUG Fosamax alendronate sodium TABLET, COATED ORAL 19961219 NDA NDA020560 Physicians Total Care, Inc. ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 54868-3861_8631cd71-b034-4a99-9683-f13a37940462 54868-3861 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20090626 ANDA ANDA077856 Physicians Total Care, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-3867_183fd856-868e-459a-8361-66ca5ac363e3 54868-3867 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole CAPSULE, DELAYED RELEASE ORAL 20001128 NDA NDA020406 Physicians Total Care, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 54868-3873_97c22a3f-3b58-4e79-8e94-0582cca3e761 54868-3873 HUMAN PRESCRIPTION DRUG Propranolol Propranolol INJECTION INTRAVENOUS 20061211 ANDA ANDA077760 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-3906_2d55557e-ec94-4ae4-aa0b-f35df835b961 54868-3906 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20041028 ANDA ANDA076631 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-3923_3e9b0b41-65ab-47e1-8790-cccf368f68aa 54868-3923 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 20000511 NDA NDA020634 Physicians Total Care, Inc. LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54868-3933_63f2458b-4cf0-493f-aab4-56e964febd24 54868-3933 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20050523 ANDA ANDA070848 Physicians Total Care, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 54868-3934_2785c2fd-f22a-43aa-a781-e1218be9a70c 54868-3934 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19970505 NDA NDA020702 Physicians Total Care, Inc ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-3935_c30dce9a-8324-4d63-970d-c3087d10cc98 54868-3935 HUMAN PRESCRIPTION DRUG Promethazine VC Promethazine Hydrochloride and Phenylephrine Hydrochloride SYRUP ORAL 20000906 ANDA ANDA040654 Physicians Total Care, Inc. PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 5; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 54868-3941_ab9d67ba-3e66-4664-a376-b65a4bfa7331 54868-3941 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20030620 NDA NDA020592 Physicians Total Care, Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 54868-3946_2785c2fd-f22a-43aa-a781-e1218be9a70c 54868-3946 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20040312 NDA NDA020702 Physicians Total Care, Inc ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-3952_d76dc06e-e796-414c-87b3-0bf34fce34fc 54868-3952 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 20080509 NDA NDA020690 Physicians Total Care, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 54868-3955_14d86267-3396-4311-9f0b-64fe41fbb8cb 54868-3955 HUMAN PRESCRIPTION DRUG Etodolac etodolac TABLET, FILM COATED ORAL 20000117 ANDA ANDA075074 Physicians Total Care, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-3974_27b8ca7e-1ac6-4b19-924a-2a0d45a76ca1 54868-3974 HUMAN PRESCRIPTION DRUG NAPRELAN naproxen sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050819 NDA NDA020353 Physicians Total Care, Inc. NAPROXEN SODIUM 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-3993_c22fa6a5-8dce-49ea-8512-0bffb3e6fcd9 54868-3993 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 20030425 NDA NDA020487 Physicians Total Care, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 54868-3996_2c6f7dc5-0214-4014-899a-d2700fc942af 54868-3996 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir CAPSULE ORAL 19980727 ANDA ANDA074727 Physicians Total Care, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 54868-3997_2c6f7dc5-0214-4014-899a-d2700fc942af 54868-3997 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 19981117 ANDA ANDA075211 Physicians Total Care, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 54868-3998_2c6f7dc5-0214-4014-899a-d2700fc942af 54868-3998 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 19981117 ANDA ANDA075211 Physicians Total Care, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 54868-3999_76eaad99-62c9-4c09-b22e-36e7e10a1265 54868-3999 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20040521 ANDA ANDA074376 Physicians Total Care, Inc. DICLOFENAC SODIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-4021_230ef06f-75a4-4bc7-942c-63ab2c7cbec8 54868-4021 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20000229 ANDA ANDA040737 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54868-4023_5f25943a-b546-481f-8076-f6fc391a0c9e 54868-4023 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 20050928 ANDA ANDA074694 Physicians Total Care, Inc. CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 54868-4030_4bf65206-846b-4dbb-898e-44c9add76830 54868-4030 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20000918 ANDA ANDA040197 Physicians Total Care, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-4031_4bf65206-846b-4dbb-898e-44c9add76830 54868-4031 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20030507 ANDA ANDA040197 Physicians Total Care, Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-4033_c50edaa2-4f73-4ed5-a237-752242c00736 54868-4033 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, EXTENDED RELEASE ORAL 20050630 ANDA ANDA075295 Physicians Total Care, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-4034_1e359210-b96e-42d3-82f0-dfb8ae2ab152 54868-4034 HUMAN PRESCRIPTION DRUG Norco Hydrocodone Bitatrate and Acetaminophen TABLET ORAL 19980513 ANDA ANDA040148 Physicians Total Care, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 54868-4035_88ef85b9-192f-4f88-9e51-7e0bd588dc35 54868-4035 HUMAN PRESCRIPTION DRUG Vicoprofen Hydrocodone Bitartrate and Ibuprofen TABLET, COATED ORAL 19980513 NDA NDA020716 Physicians Total Care, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 54868-4045_626db41f-f2a3-4f12-b0d1-40e354e1ec5b 54868-4045 HUMAN PRESCRIPTION DRUG NECON 1/35 Norethindrone and Ethinyl Estradiol KIT 20010810 ANDA ANDA070687 Physicians Total Care, Inc. 54868-4048_97338446-4ae1-4e44-a353-171793776da0 54868-4048 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 19990921 ANDA ANDA075208 Physicians Total Care, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 54868-4051_e78bcfe3-cc0f-4c23-8e5c-6d58d3837fbd 54868-4051 HUMAN PRESCRIPTION DRUG Naproxen naproxen TABLET, DELAYED RELEASE ORAL 20020111 ANDA ANDA075390 Physicians Total Care, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-4055_ea19bd36-7cb9-4836-b1f3-a2b6c852906e 54868-4055 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20070719 ANDA ANDA078627 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-4059_14d86267-3396-4311-9f0b-64fe41fbb8cb 54868-4059 HUMAN PRESCRIPTION DRUG Etodolac etodolac TABLET, FILM COATED ORAL 19990421 ANDA ANDA075074 Physicians Total Care, Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-4062_16c2a7ef-99f3-4b11-a4fd-a90471a7fddf 54868-4062 HUMAN PRESCRIPTION DRUG Captopril and Hydrochlorothiazide Captopril and Hydrochlorothiazide TABLET ORAL 20031007 ANDA ANDA074896 Physicians Total Care, Inc. CAPTOPRIL; HYDROCHLOROTHIAZIDE 50; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4066_8a1277c4-9a11-4cc9-8a6b-aea181d8c75c 54868-4066 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20050202 NDA NDA020364 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-4070_531ec738-92ae-4fd2-bf93-27bd9d9ad30d 54868-4070 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 20001121 NDA NDA020839 Physicians Total Care, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 54868-4073_8a1277c4-9a11-4cc9-8a6b-aea181d8c75c 54868-4073 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19990701 NDA NDA020364 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-4074_8a1277c4-9a11-4cc9-8a6b-aea181d8c75c 54868-4074 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20001128 NDA NDA020364 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-4079_183fd856-868e-459a-8361-66ca5ac363e3 54868-4079 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole CAPSULE, DELAYED RELEASE ORAL 20000830 NDA NDA020406 Physicians Total Care, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 54868-4082_e1df8f23-3109-4abe-8d78-afc36e64efc4 54868-4082 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 19981203 ANDA ANDA074755 Physicians Total Care, Inc. IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 54868-4084_e8b2ba9c-c643-4b32-bf96-252076556d6b 54868-4084 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 20030717 NDA NDA020895 Physicians Total Care, Inc. SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 54868-4087_05cb0c12-5291-438e-93fd-86aa7cc81611 54868-4087 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20030620 NDA NDA021301 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-4091_eb12bd6a-9815-4687-8ac7-0bb533fe0137 54868-4091 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19990224 ANDA ANDA074686 Physicians Total Care, Inc. GLYBURIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-4092_05cb0c12-5291-438e-93fd-86aa7cc81611 54868-4092 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20021115 NDA NDA021301 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-4093_61e4740e-ec39-4bcf-9aad-62ca54ce9ac5 54868-4093 HUMAN PRESCRIPTION DRUG Ortho Tri Cyclen norgestimate and ethinyl estradiol KIT 20050513 NDA NDA021690 Physicians Total Care, Inc. 54868-4095_943821b5-8382-43e2-a18b-ac8e9cde746e 54868-4095 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020411 ANDA ANDA040256 Physicians Total Care, Inc. PREDNISONE 10 mg/1 54868-4096_997397d5-0c64-459e-88f3-d8c289b37367 54868-4096 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20021127 ANDA ANDA040256 Physicians Total Care, Inc. PREDNISONE 5 mg/1 54868-4101_69f41cbb-bce2-48d9-bd95-1566adabf870 54868-4101 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 20000501 NDA NDA020998 Physicians Total Care, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-4102_712d75b9-67f4-4009-9c9e-8a9512b167e8 54868-4102 HUMAN PRESCRIPTION DRUG ORPHENADRINE CITRATE orphenadrine citrate TABLET, EXTENDED RELEASE ORAL 20000417 ANDA ANDA040284 Physicians Total Care, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 54868-4107_69f41cbb-bce2-48d9-bd95-1566adabf870 54868-4107 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19991006 NDA NDA020998 Physicians Total Care, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-4120_6e754587-6d53-44b1-a260-8ddc944d33a0 54868-4120 HUMAN PRESCRIPTION DRUG PROPECIA finasteride TABLET, FILM COATED ORAL 19971219 NDA NDA020788 Physicians Total Care, Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 54868-4125_9185f276-5046-4707-9287-6c4662b1c18f 54868-4125 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 19920419 ANDA ANDA060456 Physicians Total Care, Inc. PENICILLIN V POTASSIUM 125 mg/5mL 54868-4126_1e5cfbbe-db3d-4aa9-bb52-ab6e5afe299c 54868-4126 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20050509 ANDA ANDA019049 Physicians Total Care, Inc. TRETINOIN .025 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-4134_212beee0-c44a-465a-8113-7c1f004cb40d 54868-4134 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20040504 ANDA ANDA075491 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 54868-4135_14d86267-3396-4311-9f0b-64fe41fbb8cb 54868-4135 HUMAN PRESCRIPTION DRUG Etodolac etodolac CAPSULE ORAL 20100331 ANDA ANDA075078 Physicians Total Care, Inc. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-4142_cef15d8b-d8c6-491e-9549-695ddc33892b 54868-4142 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 20050629 NDA NDA021029 Physicians Total Care, Inc. TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 54868-4143_16881b74-dac8-403b-8a75-b1ca2732ab11 54868-4143 HUMAN PRESCRIPTION DRUG Xeloda capecitabine TABLET, FILM COATED ORAL 20050220 NDA NDA020896 Physicians Total Care, Inc. CAPECITABINE 150 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 54868-4146_40b8f8d9-52b7-43d7-9cdc-10b36cc92bfe 54868-4146 HUMAN PRESCRIPTION DRUG Lidoderm lidocaine PATCH CUTANEOUS 20030505 NDA NDA020612 Physicians Total Care, Inc. LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 54868-4149_210798f9-c1d1-4c6b-bfe9-06c02c801234 54868-4149 HUMAN PRESCRIPTION DRUG Estropipate estropipate TABLET ORAL 20030321 ANDA ANDA081214 Physicians Total Care, Inc. ESTROPIPATE 1.5 mg/1 54868-4150_db05df82-8297-4bea-9036-dc5d651cac72 54868-4150 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20041124 ANDA ANDA065387 Physicians Total Care, Inc. AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54868-4151_1c06a8e7-2281-4118-83ce-a0f45370ddcf 54868-4151 HUMAN PRESCRIPTION DRUG Femara letrozole TABLET, FILM COATED ORAL 20050210 NDA NDA020726 Physicians Total Care, Inc. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 54868-4155_db05df82-8297-4bea-9036-dc5d651cac72 54868-4155 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20090122 ANDA ANDA065387 Physicians Total Care, Inc. AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54868-4159_c3768a3d-739f-4a72-a32f-3361beed0c8a 54868-4159 HUMAN PRESCRIPTION DRUG Celexa citalopram hydrobromide TABLET ORAL 20001128 NDA NDA020822 Physicians Total Care, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-4164_58f5548b-ebc9-43e6-ba8b-525b335702db 54868-4164 HUMAN PRESCRIPTION DRUG ARTHROTEC diclofenac sodium and misoprostol TABLET, FILM COATED ORAL 20091007 NDA NDA020607 Physicians Total Care, Inc. DICLOFENAC SODIUM; MISOPROSTOL 50; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 54868-4165_58f5548b-ebc9-43e6-ba8b-525b335702db 54868-4165 HUMAN PRESCRIPTION DRUG ARTHROTEC diclofenac sodium and misoprostol TABLET, FILM COATED ORAL 20041228 NDA NDA020607 Physicians Total Care, Inc. DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 54868-4170_db8dc821-7fde-48d3-a3aa-344a845037dd 54868-4170 HUMAN PRESCRIPTION DRUG Evista Raloxifene hydrochloride TABLET ORAL 20000511 NDA NDA020815 Physicians Total Care, Inc. RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 54868-4171_0ebcdcad-8eab-4d02-99fa-436b2ac366ca 54868-4171 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20010110 ANDA ANDA074761 Physicians Total Care, Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-4174_9adfdbd6-d4a4-4510-bbbb-dc615cfcd242 54868-4174 HUMAN PRESCRIPTION DRUG NASONEX mometasone furoate SPRAY, METERED NASAL 20000512 NDA NDA020762 Physicians Total Care, Inc. MOMETASONE FUROATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4175_3e9b0b41-65ab-47e1-8790-cccf368f68aa 54868-4175 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 20000512 NDA NDA020634 Physicians Total Care, Inc. LEVOFLOXACIN 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54868-4176_05cb0c12-5291-438e-93fd-86aa7cc81611 54868-4176 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20010803 NDA NDA021301 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-4177_05cb0c12-5291-438e-93fd-86aa7cc81611 54868-4177 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20000510 NDA NDA021301 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-4184_e5f3b0c9-1c83-47b1-8de0-375ea9719d22 54868-4184 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20000515 NDA AUTHORIZED GENERIC NDA020401 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-4185_16db5abf-ec2b-49cd-8786-3adac0c005cb 54868-4185 HUMAN PRESCRIPTION DRUG Aciphex rabeprazole sodium TABLET, DELAYED RELEASE ORAL 20000515 NDA NDA020973 Physicians Total Care, Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 54868-4186_e5f3b0c9-1c83-47b1-8de0-375ea9719d22 54868-4186 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20000515 NDA AUTHORIZED GENERIC NDA020401 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-4191_035934ee-0466-4e9f-b15d-1eba7aa748d2 54868-4191 HUMAN PRESCRIPTION DRUG Biaxin Clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20001103 NDA NDA050775 Physicians Total Care, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 54868-4195_bf43abc2-5b5e-4559-9908-2fc0c5a1d2c4 54868-4195 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride JELLY TOPICAL 20000601 ANDA ANDA040433 Physicians Total Care, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 54868-4198_1bbc11e0-ee07-4207-9cd9-6cba1a83be90 54868-4198 HUMAN PRESCRIPTION DRUG Avandia rosiglitazone maleate TABLET, FILM COATED ORAL 20060207 NDA NDA021071 Physicians Total Care, Inc. ROSIGLITAZONE MALEATE 4 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 54868-4199_bfe36888-1250-4d8c-b473-064cf7dfeb1d 54868-4199 HUMAN PRESCRIPTION DRUG AVAPRO IRBESARTAN TABLET ORAL 20001121 NDA NDA020757 Physicians Total Care, Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-4211_898c5e2b-1c01-486f-a82e-0345fd3c5575 54868-4211 HUMAN PRESCRIPTION DRUG MIRAPEX pramipexole dihydrochloride TABLET ORAL 20070323 NDA NDA020667 Physicians Total Care, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 54868-4216_3caac0de-e24a-4abc-9dbb-42fd4445ceea 54868-4216 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20050422 ANDA ANDA075047 Physicians Total Care, Inc. ACEBUTOLOL HYDROCHLORIDE 400 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-4221_1bbc11e0-ee07-4207-9cd9-6cba1a83be90 54868-4221 HUMAN PRESCRIPTION DRUG Avandia rosiglitazone maleate TABLET, FILM COATED ORAL 20010509 NDA NDA021071 Physicians Total Care, Inc. ROSIGLITAZONE MALEATE 8 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 54868-4224_ef0d7cf5-ed4e-47ea-8c4c-8426e03e7c82 54868-4224 HUMAN PRESCRIPTION DRUG LESCOL fluvastatin sodium CAPSULE ORAL 20020308 NDA NDA020261 Physicians Total Care, Inc. FLUVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-4226_c3768a3d-739f-4a72-a32f-3361beed0c8a 54868-4226 HUMAN PRESCRIPTION DRUG Celexa citalopram hydrobromide TABLET ORAL 20010905 NDA NDA020822 Physicians Total Care, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-4229_2785c2fd-f22a-43aa-a781-e1218be9a70c 54868-4229 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20000706 NDA NDA020702 Physicians Total Care, Inc ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-4230_e7c2821a-12eb-4326-9b1c-ebe8f161cd3e 54868-4230 HUMAN PRESCRIPTION DRUG Prometrium progesterone CAPSULE ORAL 20041103 NDA NDA019781 Physicians Total Care, Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 54868-4232_d6c7dd01-0f74-4b23-be7b-d419f298439d 54868-4232 HUMAN PRESCRIPTION DRUG Proctozone HC hydrocortisone CREAM TOPICAL 20071030 ANDA ANDA089682 Physicians Total Care, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4233_fec3456a-b279-4603-ab4d-6a5a7df8c0a2 54868-4233 HUMAN PRESCRIPTION DRUG NuLYTELY PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride POWDER, FOR SOLUTION ORAL 20010719 NDA NDA019797 Physicians Total Care, Inc. POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 210; .74; 2.86; 5.6 g/2L; g/2L; g/2L; g/2L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 54868-4238_cf7ccdb1-796d-49b0-b840-79b467f5a2ed 54868-4238 HUMAN OTC DRUG Monistat 3 Combination Pack Miconazole Nitrate KIT 20120327 NDA NDA020670 Physicians Total Care, Inc. 54868-4239_26c90873-6f0f-499b-a9cb-dec586bfd180 54868-4239 HUMAN PRESCRIPTION DRUG Trivora Levonogestrel and Ethinyl Estradiol KIT ORAL 20030512 ANDA ANDA074538 Physicians Total Care, Inc. 54868-4240_5f47bfc7-b37f-4037-9130-9c7b22eba9eb 54868-4240 HUMAN PRESCRIPTION DRUG Zovia 1/35E-28 Ethynodiol Diacetate and Ethinyl Estradiol KIT ORAL 20030623 ANDA ANDA072721 Physicians Total Care, Inc. 54868-4242_0743df29-7a29-4a45-85a4-3b2f6bdc91d8 54868-4242 HUMAN PRESCRIPTION DRUG Vivelle Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 20030610 NDA NDA020538 Physicians Total Care, Inc. ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-4243_0743df29-7a29-4a45-85a4-3b2f6bdc91d8 54868-4243 HUMAN PRESCRIPTION DRUG Vivelle Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 20030610 NDA NDA020538 Physicians Total Care, Inc. ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-4244_0743df29-7a29-4a45-85a4-3b2f6bdc91d8 54868-4244 HUMAN PRESCRIPTION DRUG Vivelle Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 20030610 NDA NDA020538 Physicians Total Care, Inc. ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-4245_d76dc06e-e796-414c-87b3-0bf34fce34fc 54868-4245 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 20050509 NDA NDA020690 Physicians Total Care, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 54868-4247_7cf12d4f-b693-4e16-beaa-a6c0694c846a 54868-4247 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20000905 ANDA ANDA074823 Physicians Total Care, Inc. TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 54868-4248_7cf12d4f-b693-4e16-beaa-a6c0694c846a 54868-4248 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20000829 ANDA ANDA074823 Physicians Total Care, Inc. TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 54868-4249_7cf12d4f-b693-4e16-beaa-a6c0694c846a 54868-4249 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20000829 ANDA ANDA074823 Physicians Total Care, Inc. TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 54868-4250_e7c2821a-12eb-4326-9b1c-ebe8f161cd3e 54868-4250 HUMAN PRESCRIPTION DRUG Prometrium progesterone CAPSULE ORAL 20030314 NDA NDA019781 Physicians Total Care, Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 54868-4251_d0733945-7cc7-409a-bdb3-b850cee648e2 54868-4251 HUMAN PRESCRIPTION DRUG MAXALT rizatriptan benzoate TABLET ORAL 20070824 NDA NDA020864 Physicians Total Care, Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 54868-4252_4ef8ef93-8c46-4284-bd67-fa27db2f13de 54868-4252 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20010828 NDA NDA020699 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-4253_4ef8ef93-8c46-4284-bd67-fa27db2f13de 54868-4253 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030425 NDA NDA020699 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-4254_ab9d67ba-3e66-4664-a376-b65a4bfa7331 54868-4254 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20030930 NDA NDA020592 Physicians Total Care, Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 54868-4255_ab9d67ba-3e66-4664-a376-b65a4bfa7331 54868-4255 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20030820 NDA NDA020592 Physicians Total Care, Inc. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 54868-4257_a8e03fcb-e9fd-40e2-8516-febf36072b05 54868-4257 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20060428 NDA NDA020639 Physicians Total Care, Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 54868-4258_f8dca6ac-d788-471b-a766-249eb65adb6a 54868-4258 HUMAN PRESCRIPTION DRUG Allegra D-12 Hour fexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20000918 NDA NDA020786 Physicians Total Care, Inc. FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 54868-4263_d35cb135-1059-4acd-8c5b-86f33f4a6200 54868-4263 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100308 ANDA ANDA078783 Physicians Total Care, Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 54868-4271_60d25193-352b-425f-aa52-563f466a7604 54868-4271 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20010828 NDA NDA020987 Physicians Total Care, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 54868-4276_e3189b84-f38d-4e35-9c78-246d0fe55b85 54868-4276 HUMAN PRESCRIPTION DRUG ALPHAGAN P brimonidine tartrate SOLUTION/ DROPS OPHTHALMIC 20130308 NDA NDA021770 Physicians Total Care, Inc. BRIMONIDINE TARTRATE 1 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 54868-4277_2dac0cbe-637c-4cc3-86a4-9163182ac0d6 54868-4277 HUMAN PRESCRIPTION DRUG ALREX loteprednol etabonate SUSPENSION/ DROPS OPHTHALMIC 20021017 NDA NDA020803 Physicians Total Care, Inc. LOTEPREDNOL ETABONATE 2 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4278_5a11149e-7b63-44ca-b553-5cdf32c703c6 54868-4278 HUMAN PRESCRIPTION DRUG LOTEMAX loteprednol etabonate SUSPENSION/ DROPS OPHTHALMIC 20021017 NDA NDA020583 Physicians Total Care, Inc. LOTEPREDNOL ETABONATE 5 mg/mL 54868-4279_ef504bb5-a027-48e7-8d06-1801370ffcdc 54868-4279 HUMAN PRESCRIPTION DRUG Cosopt dorzolamide hydrochloride and timolol maleate SOLUTION OPHTHALMIC 20021029 NDA NDA020869 Physicians Total Care, Inc. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] 54868-4286_c6d171e1-6765-4e8a-833e-7b071efd94ed 54868-4286 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20001009 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54868-4287_6630c8a2-8c01-4ae7-a48d-0bf6ffd5b22a 54868-4287 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20050117 ANDA ANDA074858 Physicians Total Care, Inc. TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 54868-4293_b9935760-abe9-489e-89b3-16a56a906944 54868-4293 HUMAN PRESCRIPTION DRUG Prednisolone Acetate Prednisolone Acetate SUSPENSION OPHTHALMIC 20021104 NDA AUTHORIZED GENERIC NDA017469 Physicians Total Care, Inc. PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4325_56fc8547-edb1-428b-9361-d43950d80b38 54868-4325 HUMAN PRESCRIPTION DRUG BACTROBAN mupirocin calcium OINTMENT TOPICAL 19960410 NDA NDA050703 Physicians Total Care, Inc. MUPIROCIN CALCIUM 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 54868-4331_41fa6817-f138-4843-bb0c-9f757ef2098a 54868-4331 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20020102 ANDA ANDA075483 Physicians Total Care, Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-4332_41fa6817-f138-4843-bb0c-9f757ef2098a 54868-4332 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20020912 ANDA ANDA075483 Physicians Total Care, Inc. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-4335_de862ac5-a1b5-485d-ac30-b691b7027e53 54868-4335 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim Sulfate SOLUTION/ DROPS OPHTHALMIC 19970214 ANDA ANDA064120 Physicians Total Care, Inc. POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 54868-4336_f6285d9f-bf47-45e7-a767-39986c3f9e2a 54868-4336 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine SYRUP ORAL 20000913 ANDA ANDA087294 Physicians Total Care, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 54868-4338_24f5d411-51cf-4a93-9e6e-5b35b82e396e 54868-4338 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride SYRUP ORAL 20090731 ANDA ANDA040668 Physicians Total Care, Inc. CYPROHEPTADINE HYDROCHLORIDE 2 mg/5mL 54868-4341_92a650f4-8eae-459c-91ad-2b7a9f2d2092 54868-4341 HUMAN PRESCRIPTION DRUG HYZAAR losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 20040409 NDA NDA020387 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4342_f9091453-e7e9-4b6c-9f53-c5c0c4417261 54868-4342 HUMAN OTC DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20000912 ANDA ANDA076925 Physicians Total Care, Inc. IBUPROFEN 100 mg/5mL 54868-4343_bdf0fba9-2105-4e5e-b966-7cfa99a9206b 54868-4343 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 20071120 NDA NDA021073 Physicians Total Care, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 54868-4349_49c0d1e0-b392-4d27-a762-2f27405a5be3 54868-4349 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20001115 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54868-4350_97338446-4ae1-4e44-a353-171793776da0 54868-4350 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 20030919 ANDA ANDA075208 Physicians Total Care, Inc. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 54868-4352_39d05358-adcf-48a9-ad87-39e05d1fe577 54868-4352 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20061213 ANDA ANDA074700 Physicians Total Care, Inc. BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 54868-4354_bdf0fba9-2105-4e5e-b966-7cfa99a9206b 54868-4354 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 20050304 NDA NDA021073 Physicians Total Care, Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 54868-4356_36afb58e-02bb-48cd-888c-6346467b05d6 54868-4356 HUMAN PRESCRIPTION DRUG Flomax tamsulosin hydrochloride CAPSULE ORAL 20010828 NDA NDA020579 Physicians Total Care, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 54868-4357_41fa6817-f138-4843-bb0c-9f757ef2098a 54868-4357 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20001129 ANDA ANDA075483 Physicians Total Care, Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-4358_41fa6817-f138-4843-bb0c-9f757ef2098a 54868-4358 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20001129 ANDA ANDA075483 Physicians Total Care, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-4365_0c66fc6e-b13c-4efa-ac4e-82c4894ea0b8 54868-4365 HUMAN PRESCRIPTION DRUG Cipro ciprofloxacin hydrochloride, hydrocortisone and benzyl alcohol SUSPENSION AURICULAR (OTIC) 20090212 NDA NDA020805 Physicians Total Care, Inc. BENZYL ALCOHOL; CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE 9; 2; 10 mg/mL; mg/mL; mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Pediculicide [EPC] 54868-4367_67c44e69-5ed9-45a7-b661-046bea803452 54868-4367 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride TABLET, FILM COATED ORAL 20090716 NDA NDA021085 Physicians Total Care, Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54868-4369_456d2bdf-4700-4f24-aa20-2e6e6c9ed1ff 54868-4369 HUMAN PRESCRIPTION DRUG MICRONOR norethindrone TABLET ORAL 20030917 NDA NDA016954 Physicians Total Care, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54868-4370_4bf65206-846b-4dbb-898e-44c9add76830 54868-4370 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20030609 ANDA ANDA040197 Physicians Total Care, Inc. ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-4377_94fe9007-c54b-4911-9363-9ca1c3e840dc 54868-4377 HUMAN PRESCRIPTION DRUG RELENZA zanamivir POWDER RESPIRATORY (INHALATION) 20090120 NDA NDA021036 Physicians Total Care, Inc. ZANAMIVIR 5 mg/1 Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] 54868-4378_1e5cfbbe-db3d-4aa9-bb52-ab6e5afe299c 54868-4378 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20050616 ANDA ANDA017522 Physicians Total Care, Inc. TRETINOIN .05 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-4379_1e5cfbbe-db3d-4aa9-bb52-ab6e5afe299c 54868-4379 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20081017 ANDA ANDA017340 Physicians Total Care, Inc. TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-4381_d1df2bf7-621c-4b96-b2fb-1634fe9053e9 54868-4381 HUMAN PRESCRIPTION DRUG Humalog Mix75/25 Insulin lispro INJECTION, SUSPENSION SUBCUTANEOUS 20050222 NDA NDA021017 Physicians Total Care, Inc. INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 54868-4384_f7eed7fa-4c6f-4dfc-836d-4b8333aee0d3 54868-4384 HUMAN PRESCRIPTION DRUG Fosamax alendronate sodium TABLET ORAL 20001120 NDA NDA020560 Physicians Total Care, Inc. ALENDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 54868-4386_b1023888-d89d-4c9f-9c22-c1722cdc204c 54868-4386 HUMAN PRESCRIPTION DRUG Actonel risedronate sodium TABLET, FILM COATED ORAL 20020315 NDA NDA020835 Physicians Total Care, Inc. RISEDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 54868-4388_4ed8e07c-0fb2-4bfe-86c3-8e4196d98ecb 54868-4388 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110913 ANDA ANDA075665 Physicians Total Care, Inc. ETODOLAC 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-4391_bdf0fba9-2105-4e5e-b966-7cfa99a9206b 54868-4391 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 20091022 NDA NDA021073 Physicians Total Care, Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 54868-4395_1a0963fd-d3b4-457f-89af-096afb7c5152 54868-4395 HUMAN PRESCRIPTION DRUG Coreg carvedilol TABLET, FILM COATED ORAL 20030620 NDA NDA020297 Physicians Total Care, Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 54868-4396_1a0963fd-d3b4-457f-89af-096afb7c5152 54868-4396 HUMAN PRESCRIPTION DRUG Coreg carvedilol TABLET, FILM COATED ORAL 20020523 NDA NDA020297 Physicians Total Care, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 54868-4399_f56d338e-e918-4ff5-acfa-ffd56c60c9b2 54868-4399 HUMAN PRESCRIPTION DRUG Ketamine Hydrochloride Ketamine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAMUSCULAR; INTRAVENOUS 20020312 ANDA ANDA074549 Physicians Total Care, Inc. KETAMINE HYDROCHLORIDE 50 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII 54868-4400_49c0d1e0-b392-4d27-a762-2f27405a5be3 54868-4400 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20001114 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54868-4402_49c0d1e0-b392-4d27-a762-2f27405a5be3 54868-4402 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20001115 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54868-4409_e028add7-0ff7-409f-8e66-cb9e8986d403 54868-4409 HUMAN PRESCRIPTION DRUG Xopenex levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20001218 NDA NDA020837 Physicians Total Care, Inc. LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 54868-4411_c724fadf-cfb7-48da-8f80-bebc6b224284 54868-4411 HUMAN PRESCRIPTION DRUG RHINOCORT AQUA Budesonide SPRAY, METERED NASAL 20010820 NDA NDA020746 Physicians Total Care, Inc. BUDESONIDE 32 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4413_0ea9f2ea-b3e0-4b3f-a89d-075b53044db4 54868-4413 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 20001121 NDA NDA020838 Physicians Total Care, Inc. CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-4414_bfe36888-1250-4d8c-b473-064cf7dfeb1d 54868-4414 HUMAN PRESCRIPTION DRUG AVAPRO IRBESARTAN TABLET ORAL 20040510 NDA NDA020757 Physicians Total Care, Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-4416_86bbaf29-edef-432f-ba63-7ebd3f9d09bd 54868-4416 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20001127 ANDA ANDA075155 Physicians Total Care, Inc. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 54868-4417_86bbaf29-edef-432f-ba63-7ebd3f9d09bd 54868-4417 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20001127 ANDA ANDA075155 Physicians Total Care, Inc. ISOSORBIDE MONONITRATE 60 mg/1 54868-4419_23250621-f18c-486f-82a3-a9d8967e63de 54868-4419 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR; INTRAVENOUS 20001103 ANDA ANDA077942 Physicians Total Care, Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-4420_71c99c7c-76eb-425c-83d9-880c78c935a6 54868-4420 HUMAN PRESCRIPTION DRUG Glucotrol XL glipizide TABLET, EXTENDED RELEASE ORAL 20030508 NDA NDA020329 Physicians Total Care, Inc. GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-4421_1a0963fd-d3b4-457f-89af-096afb7c5152 54868-4421 HUMAN PRESCRIPTION DRUG Coreg carvedilol TABLET, FILM COATED ORAL 20001128 NDA NDA020297 Physicians Total Care, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 54868-4422_49c0d1e0-b392-4d27-a762-2f27405a5be3 54868-4422 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20001115 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54868-4424_1a0963fd-d3b4-457f-89af-096afb7c5152 54868-4424 HUMAN PRESCRIPTION DRUG Coreg carvedilol TABLET, FILM COATED ORAL 20001128 NDA NDA020297 Physicians Total Care, Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 54868-4425_745ce298-abcb-4d11-8c0e-79776cdc6e2e 54868-4425 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20090622 NDA NDA020818 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4428_745ce298-abcb-4d11-8c0e-79776cdc6e2e 54868-4428 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4431_3883e227-acaf-4daf-8319-6dc2fb5b6293 54868-4431 HUMAN PRESCRIPTION DRUG Sonata zaleplon CAPSULE ORAL 20040401 NDA NDA020859 Physicians Total Care, Inc. ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 54868-4432_5651bc48-1227-4ca9-aaf9-805771c27090 54868-4432 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20001128 ANDA ANDA074587 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-4435_fc7059c3-f7ca-44e6-97d3-032fa8154037 54868-4435 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20001204 ANDA ANDA075366 Physicians Total Care, Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 54868-4437_07f602ad-4afc-41c3-b5cb-0dfca799acf4 54868-4437 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100310 ANDA ANDA090377 Physicians Total Care, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 54868-4438_70bc4da3-ae56-4157-abe8-d4f60b457e66 54868-4438 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20020523 ANDA ANDA075640 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4442_0a0a3e7e-68d9-4201-bd3d-4fe0d7caf35b 54868-4442 HUMAN PRESCRIPTION DRUG AZELEX azelaic acid CREAM CUTANEOUS 20070531 NDA NDA020428 Physicians Total Care, Inc. AZELAIC ACID .2 g/g Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE] 54868-4444_1e5cfbbe-db3d-4aa9-bb52-ab6e5afe299c 54868-4444 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20090105 ANDA ANDA017579 Physicians Total Care, Inc. TRETINOIN .025 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-4448_cf0db9fc-dd0a-4976-a6a1-eeb3393e6511 54868-4448 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20010801 ANDA ANDA076294 Physicians Total Care, Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 54868-4449_91407a94-b1c0-4ff9-a132-1c5168a2f4e2 54868-4449 HUMAN PRESCRIPTION DRUG NORITATE metronidazole CREAM TOPICAL 20050929 NDA NDA020743 Physicians Total Care, Inc. METRONIDAZOLE 10 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 54868-4451_7376e718-265d-4d1c-9eea-d044aaf034fe 54868-4451 HUMAN PRESCRIPTION DRUG Hydrocortisone Valerate Hydrocortisone Valerate CREAM TOPICAL 20020204 ANDA ANDA075042 Physicians Total Care, Inc. HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4453_72c76cf5-5886-4571-ad5b-3ab9869ddac2 54868-4453 HUMAN PRESCRIPTION DRUG Desonide Desonide OINTMENT TOPICAL 20060621 NDA NDA017426 Physicians Total Care, Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4456_96f093aa-a72d-4459-b737-f9ac09dd03ca 54868-4456 HUMAN PRESCRIPTION DRUG Tazorac Tazarotene GEL ORAL 20101021 NDA NDA020600 Physicians Total Care, Inc. TAZAROTENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-4462_f7eed7fa-4c6f-4dfc-836d-4b8333aee0d3 54868-4462 HUMAN PRESCRIPTION DRUG Fosamax alendronate sodium TABLET ORAL 20100217 NDA NDA020560 Physicians Total Care, Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 54868-4463_f7eed7fa-4c6f-4dfc-836d-4b8333aee0d3 54868-4463 HUMAN PRESCRIPTION DRUG Fosamax alendronate sodium TABLET ORAL 20010205 NDA NDA020560 Physicians Total Care, Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 54868-4464_02ff92cb-2962-4bf9-9ad7-68971dd03345 54868-4464 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20010208 NDA NDA018803 Physicians Total Care, Inc. SODIUM CHLORIDE 9 mg/mL 54868-4468_db05df82-8297-4bea-9036-dc5d651cac72 54868-4468 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060228 ANDA ANDA065378 Physicians Total Care, Inc. AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54868-4474_ab2d1f67-4b2a-4b51-ba4d-7a01b8577549 54868-4474 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride TABLET, FILM COATED ORAL 20020417 NDA NDA021176 Physicians Total Care, Inc. COLESEVELAM HYDROCHLORIDE 625 mg/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 54868-4476_88cfbec5-a553-46d5-bbfc-2c3a29b7f171 54868-4476 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 20021028 NDA NDA021087 Physicians Total Care, Inc. OSELTAMIVIR PHOSPHATE 75 mg/1 Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] 54868-4477_91fda3d6-bdfe-4dcd-84ea-32817ce41a78 54868-4477 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20030911 ANDA ANDA040353 Physicians Total Care, Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 54868-4478_b141986d-5629-48d6-bf20-802ae2fc2dcb 54868-4478 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET ORAL 20120718 NDA AUTHORIZED GENERIC NDA020215 Physicians Total Care, Inc. ISOSORBIDE MONONITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 54868-4482_943adc58-3c44-4b5e-b7da-20d4b550a65b 54868-4482 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20010404 ANDA ANDA040597 Physicians Total Care, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 54868-4489_1c304460-91d1-4710-bcc9-8c9621b36a0b 54868-4489 HUMAN PRESCRIPTION DRUG Concerta Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20030321 NDA NDA021121 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-4492_219741f7-4f2b-4db1-aaca-4dc0482310df 54868-4492 HUMAN PRESCRIPTION DRUG PROVIGIL MODAFINIL TABLET ORAL 20050603 NDA NDA020717 Physicians Total Care, Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 54868-4494_4fe6e815-1d03-40df-ad3d-4d12de9648dc 54868-4494 HUMAN PRESCRIPTION DRUG Avalide irbesartan and hydrochlorothiazide TABLET ORAL 20010517 NDA NDA020758 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4497_2a0dd457-4727-47ff-9268-e9e1b9d17b30 54868-4497 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 20040123 NDA NDA020475 Physicians Total Care, Inc. TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-4499_d0733945-7cc7-409a-bdb3-b850cee648e2 54868-4499 HUMAN PRESCRIPTION DRUG MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20091229 NDA NDA020865 Physicians Total Care, Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 54868-4502_03c5b3bd-62d0-4eec-8387-14ad97a93bba 54868-4502 HUMAN PRESCRIPTION DRUG Ditropan XL oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 20030623 NDA NDA020897 Physicians Total Care, Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54868-4503_241104fd-a64f-4af3-b940-901cb4105875 54868-4503 HUMAN PRESCRIPTION DRUG CASODEX Bicalutamide TABLET ORAL 20020604 NDA NDA020498 Physicians Total Care, Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 54868-4504_4ef8ef93-8c46-4284-bd67-fa27db2f13de 54868-4504 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20040407 NDA NDA020699 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-4507_54642793-18db-4fca-9056-a2ca5a740e59 54868-4507 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20010416 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-4510_f7dd9177-838b-41a0-91e4-6e87100b7001 54868-4510 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20020502 NDA NDA021153 Physicians Total Care, Inc. ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 54868-4512_7c89711c-07e8-404e-9946-bdaefdff3df1 54868-4512 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20020412 NDA NDA020823 Physicians Total Care, Inc. RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 54868-4514_3056bc9b-abd8-4f5a-bb6b-4acb629afac5 54868-4514 HUMAN PRESCRIPTION DRUG Detrol LA tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20040903 NDA NDA021228 Physicians Total Care, Inc. TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54868-4515_fafcadd8-ff09-404c-b213-4edc15a22863 54868-4515 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, EXTENDED RELEASE ORAL 20030325 ANDA ANDA075028 Physicians Total Care, Inc. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 54868-4516_f5991045-2524-422b-b5f4-af367fc2da81 54868-4516 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER ORAL; RESPIRATORY (INHALATION) 20010621 NDA NDA021077 Physicians Total Care, Inc. FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 500; 50 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4517_f5991045-2524-422b-b5f4-af367fc2da81 54868-4517 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER ORAL; RESPIRATORY (INHALATION) 20010621 NDA NDA021077 Physicians Total Care, Inc. FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 250; 50 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4518_f5991045-2524-422b-b5f4-af367fc2da81 54868-4518 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER ORAL; RESPIRATORY (INHALATION) 20010621 NDA NDA021077 Physicians Total Care, Inc. FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 100; 50 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4525_373589f7-8b10-4196-a4ce-f80ea3f086c2 54868-4525 HUMAN PRESCRIPTION DRUG Elmiron pentosan polysulfate sodium CAPSULE, GELATIN COATED ORAL 20031217 NDA NDA020193 Physicians Total Care, Inc. PENTOSAN POLYSULFATE SODIUM 100 mg/1 Glycosaminoglycan [EPC],Glycosaminoglycans [Chemical/Ingredient] 54868-4526_4fe6e815-1d03-40df-ad3d-4d12de9648dc 54868-4526 HUMAN PRESCRIPTION DRUG Avalide irbesartan and hydrochlorothiazide TABLET ORAL 20040908 NDA NDA020758 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4528_179b7b73-1458-4d3e-9f29-84e3ffe14c7d 54868-4528 HUMAN PRESCRIPTION DRUG PATANOL olopatadine hydrochloride SOLUTION/ DROPS OPHTHALMIC 20020508 NDA NDA020688 Physicians Total Care, Inc. OLOPATADINE HYDROCHLORIDE 1 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] CV 54868-4531_880eae0b-083d-495b-96d3-e268f7b62b07 54868-4531 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20090305 ANDA ANDA077899 Physicians Total Care, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54868-4532_880eae0b-083d-495b-96d3-e268f7b62b07 54868-4532 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20070703 ANDA ANDA077899 Physicians Total Care, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54868-4534_05cb0c12-5291-438e-93fd-86aa7cc81611 54868-4534 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20010803 NDA NDA021301 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-4535_05cb0c12-5291-438e-93fd-86aa7cc81611 54868-4535 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20010822 NDA NDA021301 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-4536_05cb0c12-5291-438e-93fd-86aa7cc81611 54868-4536 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20011211 NDA NDA021301 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-4537_6876c1b2-e3b1-474d-b8e1-5bf7e4b14d1d 54868-4537 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride CAPSULE ORAL 20081023 ANDA ANDA075207 Physicians Total Care, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-4539_d6d6402a-3913-4adf-b6e6-f4676533a3a5 54868-4539 HUMAN PRESCRIPTION DRUG Micardis TELMISARTAN TABLET ORAL 20050119 NDA NDA020850 Physicians Total Care, Inc. TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-4540_e8331ace-719a-4405-97f1-fb137e7c2444 54868-4540 HUMAN PRESCRIPTION DRUG Micardis HCT TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET ORAL 20041216 NDA NDA021162 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4543_db05df82-8297-4bea-9036-dc5d651cac72 54868-4543 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20020312 ANDA ANDA065228 Physicians Total Care, Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54868-4546_80b4b640-1b66-41c8-ac0b-9cb14780db7f 54868-4546 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20010831 ANDA ANDA075673 Physicians Total Care, Inc. BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE .64; 10 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4548_77353d67-b531-4a49-b2c7-d70e42922a31 54868-4548 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET ORAL 20010904 ANDA ANDA075844 Physicians Total Care, Inc. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-4550_212beee0-c44a-465a-8113-7c1f004cb40d 54868-4550 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20040519 ANDA ANDA075491 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 54868-4556_14d729b6-586a-44cb-9589-ec032c0bc190 54868-4556 HUMAN PRESCRIPTION DRUG NABUMETONE Nabumetone TABLET, FILM COATED ORAL 20030915 ANDA ANDA078671 Physicians Total Care, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-4558_14d729b6-586a-44cb-9589-ec032c0bc190 54868-4558 HUMAN PRESCRIPTION DRUG NABUMETONE Nabumetone TABLET, FILM COATED ORAL 20021204 ANDA ANDA078671 Physicians Total Care, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-4560_0be54cea-ea5c-4c98-83c1-0d3ba1aa9d12 54868-4560 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride TABLET, FILM COATED ORAL 20030819 ANDA ANDA075755 Physicians Total Care, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-4561_28e99e2c-3ec7-4dbd-9977-1d8e30689190 54868-4561 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET ORAL 20020312 ANDA ANDA075967 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-4562_6876c1b2-e3b1-474d-b8e1-5bf7e4b14d1d 54868-4562 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine CAPSULE ORAL 20080725 ANDA ANDA075207 Physicians Total Care, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-4563_c1b540fa-05c6-4d49-ad9f-7a84c295771d 54868-4563 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20070710 ANDA ANDA075718 Physicians Total Care, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 54868-4564_28e99e2c-3ec7-4dbd-9977-1d8e30689190 54868-4564 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET ORAL 20020130 ANDA ANDA075967 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-4565_9bc8a9f9-3e12-46c0-a145-8a5f8cc09f88 54868-4565 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone TABLET ORAL 20041221 ANDA ANDA074253 Physicians Total Care, Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 54868-4566_28e99e2c-3ec7-4dbd-9977-1d8e30689190 54868-4566 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET ORAL 20020311 ANDA ANDA075967 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-4567_c1b540fa-05c6-4d49-ad9f-7a84c295771d 54868-4567 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20021115 ANDA ANDA075718 Physicians Total Care, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 54868-4568_9bc8a9f9-3e12-46c0-a145-8a5f8cc09f88 54868-4568 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone TABLET ORAL 20090723 ANDA ANDA074253 Physicians Total Care, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 54868-4571_8ea73dd1-dfe3-4628-940f-16587e605fcb 54868-4571 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20011107 NDA NDA020616 Physicians Total Care, Inc. MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-4572_8ea73dd1-dfe3-4628-940f-16587e605fcb 54868-4572 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20011107 NDA NDA020616 Physicians Total Care, Inc. MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-4573_8ea73dd1-dfe3-4628-940f-16587e605fcb 54868-4573 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20081120 NDA NDA020616 Physicians Total Care, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-4575_79525f6c-c645-444a-acc1-93bc46edb8a1 54868-4575 HUMAN PRESCRIPTION DRUG LUMIGAN bimatoprost SOLUTION/ DROPS OPHTHALMIC 20010322 NDA NDA021275 Physicians Total Care, Inc. BIMATOPROST .3 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 54868-4576_c8c7e31c-5ea0-4a5b-8502-0bc7c7d4f065 54868-4576 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20020115 ANDA ANDA075579 Physicians Total Care, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4577_c8c7e31c-5ea0-4a5b-8502-0bc7c7d4f065 54868-4577 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20030612 ANDA ANDA075579 Physicians Total Care, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4578_c8c7e31c-5ea0-4a5b-8502-0bc7c7d4f065 54868-4578 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20030801 ANDA ANDA075579 Physicians Total Care, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4582_1d82d084-abe7-4338-9f86-f607eb96ed12 54868-4582 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20100301 ANDA ANDA075765 Physicians Total Care, Inc. CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 54868-4584_1d82d084-abe7-4338-9f86-f607eb96ed12 54868-4584 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20051202 ANDA ANDA075765 Physicians Total Care, Inc. CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 54868-4585_98543b6f-554a-4697-af40-372f3da2219f 54868-4585 HUMAN PRESCRIPTION DRUG LOVASTATIN Lovastatin TABLET ORAL 20011221 ANDA ANDA078296 Physicians Total Care, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-4590_437e15f5-0f4b-4c76-ad83-9d2c3cfdac55 54868-4590 HUMAN PRESCRIPTION DRUG Yasmin drospirenone and ethinyl estradiol KIT 20020115 NDA NDA021098 Physicians Total Care, Inc. 54868-4591_5c7fe409-289d-43d1-a9d4-1ee8eda9b07c 54868-4591 HUMAN PRESCRIPTION DRUG Verelan verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 20030612 NDA NDA019614 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-4593_98543b6f-554a-4697-af40-372f3da2219f 54868-4593 HUMAN PRESCRIPTION DRUG LOVASTATIN Lovastatin TABLET ORAL 20020128 ANDA ANDA078296 Physicians Total Care, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-4598_e387fd18-7c90-431b-8e9b-b381edb43c49 54868-4598 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, FILM COATED ORAL 20020206 ANDA ANDA076855 Physicians Total Care, Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-4599_2192ea4b-7e98-4eb1-8415-570eeb6d2065 54868-4599 HUMAN PRESCRIPTION DRUG Ammonium Lactate Ammonium Lactate LOTION TOPICAL 20020214 ANDA ANDA075570 Physicians Total Care, Inc. AMMONIUM LACTATE 12 g/100g 54868-4601_d1bfcf48-31d0-49a7-9b3e-e64d4bc11b87 54868-4601 HUMAN PRESCRIPTION DRUG LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE ORAL 20020312 NDA NDA021192 Physicians Total Care, Inc. FLUVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-4602_dba74198-1341-41e1-9f6e-a756104c434b 54868-4602 HUMAN PRESCRIPTION DRUG Levothroid LEVOTHYROXINE SODIUM TABLET ORAL 20020308 NDA NDA021116 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-4605_d6d6402a-3913-4adf-b6e6-f4676533a3a5 54868-4605 HUMAN PRESCRIPTION DRUG Micardis TELMISARTAN TABLET ORAL 20020325 NDA NDA020850 Physicians Total Care, Inc. TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-4607_832533a9-e6b5-4121-a23b-a8591c9c0bc7 54868-4607 HUMAN PRESCRIPTION DRUG Levora Levonorgestrel and Ethinyl Estradiol KIT ORAL 20020410 ANDA ANDA073594 Physicians Total Care, Inc. 54868-4609_9dff28ce-aa5f-47ba-88e6-7435bdcc3bba 54868-4609 HUMAN PRESCRIPTION DRUG GLUCOVANCE GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20020531 NDA NDA021178 Physicians Total Care, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-4617_e1f4e093-cf3f-4ce0-ba22-3fc5f3c4251c 54868-4617 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020419 ANDA ANDA075604 Physicians Total Care, Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 54868-4618_025855e1-a0be-4aeb-a346-bb36c3dfe872 54868-4618 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20020422 ANDA ANDA079029 Physicians Total Care, Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 54868-4624_eb68b814-4b53-4c44-95de-2cc71d442a9c 54868-4624 HUMAN PRESCRIPTION DRUG Clarinex desloratidine TABLET, FILM COATED ORAL 20020603 NDA NDA021297 Physicians Total Care, Inc. DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 54868-4626_929a6a1f-8668-425d-aec4-15793be80ea7 54868-4626 HUMAN PRESCRIPTION DRUG Lantus insulin glargin INJECTION, SOLUTION SUBCUTANEOUS 20020604 NDA NDA021081 Physicians Total Care, Inc. INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 54868-4630_ff09d876-3fc3-4826-b04b-f600a4cfba83 54868-4630 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 20020530 NDA NDA020830 Physicians Total Care, Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 54868-4631_e1ec8388-3aeb-4259-8201-486191f06c84 54868-4631 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20020604 ANDA ANDA040440 Physicians Total Care, Inc. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-4635_f7dd9177-838b-41a0-91e4-6e87100b7001 54868-4635 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20020617 NDA NDA021153 Physicians Total Care, Inc. ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 54868-4637_c92105c7-4189-49dd-b3c2-88f37b80b422 54868-4637 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20090623 ANDA ANDA076007 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4638_d4ab1662-3ee5-454c-ab23-22e679e5ab78 54868-4638 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20020621 ANDA ANDA076003 Physicians Total Care, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 54868-4640_bdecce86-e035-472d-8131-180414c321fe 54868-4640 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20050301 NDA NDA021303 Physicians Total Care, Inc. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-4642_76d3c42c-12e8-4135-8ccf-3f3cb2d49de0 54868-4642 HUMAN PRESCRIPTION DRUG Bactroban mupirocin calcium CREAM TOPICAL 20020712 NDA NDA050746 Physicians Total Care, Inc. MUPIROCIN CALCIUM 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 54868-4645_7c4c1776-6fe6-419a-9eb6-3e365693efa3 54868-4645 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20080228 NDA NDA021283 Physicians Total Care, Inc. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-4646_993c5da6-8c27-4df7-a136-c2814e50ba60 54868-4646 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20040825 ANDA ANDA075994 Physicians Total Care, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-4647_9bc8a9f9-3e12-46c0-a145-8a5f8cc09f88 54868-4647 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone TABLET ORAL 20070917 ANDA ANDA074253 Physicians Total Care, Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 54868-4651_ff21fddf-da6b-49cb-b27f-20e8fde8e6db 54868-4651 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin sodium INJECTION INTRAMUSCULAR 20030915 ANDA ANDA065047 Physicians Total Care, Inc. CEFAZOLIN SODIUM 500 mg/10mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54868-4652_7c4c1776-6fe6-419a-9eb6-3e365693efa3 54868-4652 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20100106 NDA NDA021283 Physicians Total Care, Inc. VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-4654_4c539f04-059e-485a-8a8e-038ccb474b2b 54868-4654 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate GEL TOPICAL 20050407 ANDA ANDA064160 Physicians Total Care, Inc. CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 54868-4656_993c5da6-8c27-4df7-a136-c2814e50ba60 54868-4656 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20090216 ANDA ANDA075994 Physicians Total Care, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-4657_993c5da6-8c27-4df7-a136-c2814e50ba60 54868-4657 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20050725 ANDA ANDA075994 Physicians Total Care, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-4658_993c5da6-8c27-4df7-a136-c2814e50ba60 54868-4658 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20070917 ANDA ANDA075994 Physicians Total Care, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-4663_0d231e91-00f1-482d-aa82-01031de593af 54868-4663 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20090916 ANDA ANDA074046 Physicians Total Care, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-4665_e899df9b-095c-4c16-895f-3307f9810383 54868-4665 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031203 NDA NDA021368 Physicians Total Care, Inc. TADALAFIL 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 54868-4668_0e9a5a51-266a-490c-90fd-f553a5d378de 54868-4668 HUMAN PRESCRIPTION DRUG SUSTIVA efavirenz TABLET, FILM COATED ORAL 20121011 NDA NDA021360 Physicians Total Care, Inc. EFAVIRENZ 600 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] 54868-4671_b1023888-d89d-4c9f-9c22-c1722cdc204c 54868-4671 HUMAN PRESCRIPTION DRUG Actonel risedronate sodium TABLET, FILM COATED ORAL 20020916 NDA NDA020835 Physicians Total Care, Inc. RISEDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 54868-4672_1464cdb0-3223-4e7b-81fb-c9f1b4a57f0f 54868-4672 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 20040108 NDA NDA020505 Physicians Total Care, Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-4673_430621f8-c3cb-44a1-88f4-b13adbba4bfd 54868-4673 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 20110216 NDA NDA020241 Physicians Total Care, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 54868-4674_1464cdb0-3223-4e7b-81fb-c9f1b4a57f0f 54868-4674 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 20030723 NDA NDA020505 Physicians Total Care, Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-4675_430621f8-c3cb-44a1-88f4-b13adbba4bfd 54868-4675 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 20080509 NDA NDA020241 Physicians Total Care, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 54868-4677_d59bd7ca-4da9-4f02-942a-d99066b741eb 54868-4677 HUMAN PRESCRIPTION DRUG Estradiol / Norethindrone Acetate Estradiol and Norethindrone Acetate TABLET, FILM COATED ORAL 20100310 ANDA ANDA078324 Physicians Total Care, Inc. ESTRADIOL; NORETHINDRONE ACETATE 1; .5 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54868-4678_993c5da6-8c27-4df7-a136-c2814e50ba60 54868-4678 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20080410 ANDA ANDA075994 Physicians Total Care, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-4679_50ce7901-3328-49fe-a773-ed3ca33e6320 54868-4679 HUMAN PRESCRIPTION DRUG femhrt norethindrone acetate/ethinyl estradiol TABLET ORAL 20020924 NDA NDA021065 Physicians Total Care, Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 5; 1 ug/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-4683_03e2ff00-c8ab-43dc-94af-4705dde13a8c 54868-4683 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20080420 ANDA ANDA065390 Physicians Total Care, Inc. RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 54868-4687_f1bacd71-d3dc-44ac-aa69-ea49bbf77be5 54868-4687 HUMAN PRESCRIPTION DRUG Demadex Torsemide TABLET ORAL 20091021 NDA NDA020136 Physicians Total Care, Inc. TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 54868-4690_e3189b84-f38d-4e35-9c78-246d0fe55b85 54868-4690 HUMAN PRESCRIPTION DRUG ALPHAGAN P brimonidine tartrate SOLUTION/ DROPS OPHTHALMIC 20021016 NDA NDA021262 Physicians Total Care, Inc. BRIMONIDINE TARTRATE 1.5 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 54868-4691_0b4809cb-28f6-463c-87a9-31ef3cccc4ed 54868-4691 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION OPHTHALMIC 20021016 NDA NDA020330 Physicians Total Care, Inc. TIMOLOL MALEATE 6.8 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-4697_b7a5e37c-1554-4ba6-8950-19e2bfddba69 54868-4697 HUMAN PRESCRIPTION DRUG Cyclopentolate Hydrochloride Cyclopentolate Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20130110 ANDA ANDA040075 Physicians Total Care, Inc. CYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL 54868-4698_a8c8707d-f588-4cd9-b5d6-93aca8fda7c4 54868-4698 HUMAN OTC DRUG Sodium Chloride Sodium Chloride OINTMENT OPHTHALMIC 20060330 OTC MONOGRAPH FINAL part349 Physicians Total Care, Inc. SODIUM CHLORIDE 50 mg/g 54868-4700_2c717d2f-6a42-44cd-815f-3efe43cce3c8 54868-4700 HUMAN PRESCRIPTION DRUG Lexapro escitalopram oxalate TABLET ORAL 20051228 NDA NDA021323 Physicians Total Care, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-4703_03e281c5-b5df-437d-a6d1-150c1be83262 54868-4703 HUMAN PRESCRIPTION DRUG ULTRACET tramadol hydrochloride and acetaminophen TABLET, COATED ORAL 20021030 NDA NDA021123 Physicians Total Care, Inc. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 54868-4705_b5a4afc1-5622-4146-b1af-66f54f922425 54868-4705 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20070913 NDA NDA021518 Physicians Total Care, Inc. SOLIFENACIN SUCCINATE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54868-4706_e8b2ba9c-c643-4b32-bf96-252076556d6b 54868-4706 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 20100211 NDA NDA020895 Physicians Total Care, Inc. SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 54868-4711_6d47c815-1af7-4a96-9daf-e1a63050cea4 54868-4711 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20021202 ANDA ANDA090624 Physicians Total Care, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 54868-4714_36f5e14a-0d01-4aef-b298-4a92c4c2a777 54868-4714 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20021211 ANDA ANDA075410 Physicians Total Care, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 54868-4718_79201e83-d9e6-42a7-98b6-bd51edbdc233 54868-4718 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20021223 NDA NDA021259 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-4719_d63c02ef-a2c3-4dd1-b61e-6cd29b5ef341 54868-4719 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20021226 NDA NDA021445 Physicians Total Care, Inc. EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] 54868-4721_a5ed6899-9939-456c-9735-a418b7ce6357 54868-4721 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 20030210 ANDA ANDA040101 Physicians Total Care, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54868-4725_ec557674-815f-4ad7-8922-f1d38a499ea5 54868-4725 HUMAN PRESCRIPTION DRUG Dovonex calcipotriene CREAM TOPICAL 20060915 NDA NDA020554 Physicians Total Care, Inc. CALCIPOTRIENE 50 ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 54868-4728_e1ec8388-3aeb-4259-8201-486191f06c84 54868-4728 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20030117 ANDA ANDA040440 Physicians Total Care, Inc. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-4729_714d8082-a99d-4580-9ff6-2c569bbbda65 54868-4729 HUMAN PRESCRIPTION DRUG ATACAND HCT Candesartan cilexetil and Hydrochlorothiazide TABLET ORAL 20030121 NDA NDA021093 Physicians Total Care, Inc. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 16; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4730_27230615-7bf4-4bbd-b548-1acfe18c1635 54868-4730 HUMAN PRESCRIPTION DRUG ORTHO TRI CYCLEN Lo norgestimate and ethinyl estradiol KIT 20030123 NDA NDA021241 Physicians Total Care, Inc. 54868-4733_8d2e23e7-c5fb-47f6-99b0-7a7fdf823da5 54868-4733 HUMAN PRESCRIPTION DRUG Skelaxin Metaxalone TABLET ORAL 20030130 NDA NDA013217 Physicians Total Care, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 54868-4735_dfaf9a26-c4ea-4a66-9723-c55ad6d6dffb 54868-4735 HUMAN PRESCRIPTION DRUG AugmentinXR amoxicillin and clavulanate potassium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030130 NDA NDA050785 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 1000; 62.5 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54868-4742_d6110a6b-a8dd-4090-ac83-fda8fcfebd9e 54868-4742 HUMAN PRESCRIPTION DRUG KARIVA desogestrel/ethinyl estradiol and ethinyl estradiol KIT 20030218 ANDA ANDA075863 Physicians Total Care, Inc. 54868-4743_96632530-85c4-4b9f-a751-42981e9a0d4c 54868-4743 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20030221 ANDA ANDA065064 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54868-4744_2da371ca-e885-413a-849b-cc6a10ac6219 54868-4744 HUMAN PRESCRIPTION DRUG Microgestin Fe Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20030224 ANDA ANDA075647 Physicians Total Care, Inc. 54868-4747_284c446e-aa73-4f3d-87b3-b4c28c56c08e 54868-4747 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen SOLUTION ORAL 20030327 ANDA ANDA040182 Physicians Total Care, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 167; 2.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 54868-4748_6c8f1031-01ab-43e8-b0f7-ec96b66e618b 54868-4748 HUMAN PRESCRIPTION DRUG Prednisolone prednisolone SYRUP ORAL 20030228 ANDA ANDA040423 Physicians Total Care, Inc. PREDNISOLONE 5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4749_6c8f1031-01ab-43e8-b0f7-ec96b66e618b 54868-4749 HUMAN PRESCRIPTION DRUG Prednisolone prednisolone SYRUP ORAL 20030228 ANDA ANDA040323 Physicians Total Care, Inc. PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4750_9bc7d9be-cbb2-42f7-a965-482a7c9fc184 54868-4750 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20030305 NDA NDA021282 Physicians Total Care, Inc. GUAIFENESIN 600 mg/1 54868-4751_2ed9b59c-40be-4140-aa8e-1584dcd09329 54868-4751 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20030311 NDA NDA021171 Physicians Total Care, Inc. MEPERIDINE HYDROCHLORIDE 100 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-4754_93099c25-5a99-4140-8837-120ab66570b4 54868-4754 HUMAN PRESCRIPTION DRUG APRI Desogestrel and Ethinyl Estradiol KIT 20030310 ANDA ANDA075256 Physicians Total Care, Inc. 54868-4759_1c304460-91d1-4710-bcc9-8c9621b36a0b 54868-4759 HUMAN PRESCRIPTION DRUG Concerta Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20030320 NDA NDA021121 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 36 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-4760_bdecce86-e035-472d-8131-180414c321fe 54868-4760 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20030320 NDA NDA021303 Physicians Total Care, Inc. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-4761_210798f9-c1d1-4c6b-bfe9-06c02c801234 54868-4761 HUMAN PRESCRIPTION DRUG Estropipate estropipate TABLET ORAL 20030326 ANDA ANDA081215 Physicians Total Care, Inc. ESTROPIPATE 3 mg/1 54868-4767_d31c8c05-2dc2-44bc-9702-2ff81ef2ed88 54868-4767 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20030403 ANDA ANDA075509 Physicians Total Care, Inc. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 54868-4768_41cac0ee-a39b-4f65-b3b2-fb48d7dbf777 54868-4768 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate SF guaifenesin and codeine phosphate LIQUID ORAL 20110426 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 54868-4770_c92c4adf-6ff2-4eda-a868-b0af18b08ae6 54868-4770 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride TABLET, FILM COATED ORAL 20050518 ANDA ANDA075998 Physicians Total Care, Inc. PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] 54868-4773_5d76dd07-6818-4ef2-9fa5-36c3d367f6dd 54868-4773 HUMAN PRESCRIPTION DRUG HYDROXYUREA Hydroxyurea CAPSULE ORAL 20030411 ANDA ANDA075143 Physicians Total Care, Inc. HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] 54868-4774_98543b6f-554a-4697-af40-372f3da2219f 54868-4774 HUMAN PRESCRIPTION DRUG LOVASTATIN Lovastatin TABLET ORAL 20030414 ANDA ANDA078296 Physicians Total Care, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-4775_2c717d2f-6a42-44cd-815f-3efe43cce3c8 54868-4775 HUMAN PRESCRIPTION DRUG Lexapro escitalopram oxalate TABLET ORAL 20090415 NDA NDA021323 Physicians Total Care, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-4778_5f47bfc7-b37f-4037-9130-9c7b22eba9eb 54868-4778 HUMAN PRESCRIPTION DRUG Zovia 1/50E-28 Ethynodiol Diacetate and Ethinyl Estradiol KIT ORAL 20030421 ANDA ANDA072723 Physicians Total Care, Inc. 54868-4779_09893986-19e0-4364-93ba-5fbc7e7d3eed 54868-4779 HUMAN PRESCRIPTION DRUG UROCIT-K potassium citrate TABLET, EXTENDED RELEASE ORAL 20030417 NDA NDA019071 Physicians Total Care, Inc. POTASSIUM CITRATE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 54868-4780_993c5da6-8c27-4df7-a136-c2814e50ba60 54868-4780 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20070412 ANDA ANDA075994 Physicians Total Care, Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-4784_e8b2ba9c-c643-4b32-bf96-252076556d6b 54868-4784 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 20030430 NDA NDA020895 Physicians Total Care, Inc. SILDENAFIL CITRATE 25 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 54868-4785_c92105c7-4189-49dd-b3c2-88f37b80b422 54868-4785 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20070918 ANDA ANDA076007 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4786_60d25193-352b-425f-aa52-563f466a7604 54868-4786 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20030502 NDA NDA020987 Physicians Total Care, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 54868-4789_1c304460-91d1-4710-bcc9-8c9621b36a0b 54868-4789 HUMAN PRESCRIPTION DRUG Concerta Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20030508 NDA NDA021121 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 54 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-4791_52f498a2-11b0-46be-bb67-14054aa3c2c5 54868-4791 HUMAN PRESCRIPTION DRUG PAXILCR CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030516 NDA NDA020936 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-4792_e1db502f-fa92-4a34-9c93-68bdfb38ba85 54868-4792 HUMAN PRESCRIPTION DRUG Androgel Testosterone GEL TRANSDERMAL 20030515 NDA NDA021015 Physicians Total Care, Inc. TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 54868-4793_10aaf531-4033-442c-821d-69292ccf5f85 54868-4793 HUMAN PRESCRIPTION DRUG RESTASIS cyclosporine EMULSION OPHTHALMIC 20090327 NDA NDA050790 Physicians Total Care, Inc. CYCLOSPORINE .5 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 54868-4794_0da34cd6-c336-4f3c-b29f-06a1eaae90ac 54868-4794 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20030520 ANDA ANDA040603 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54868-4798_b0271054-5ec6-4bd4-9dfb-7bd4092ad668 54868-4798 HUMAN PRESCRIPTION DRUG VIGAMOX moxifloxacin hydrochloride SOLUTION OPHTHALMIC 20030522 NDA NDA021598 Physicians Total Care, Inc. MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54868-4799_ad2bc73b-0000-44fa-aacb-22432871e093 54868-4799 HUMAN PRESCRIPTION DRUG Flunisolide Flunisolide SOLUTION NASAL 20030523 ANDA ANDA074805 Physicians Total Care, Inc. FLUNISOLIDE .25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4801_d31c8c05-2dc2-44bc-9702-2ff81ef2ed88 54868-4801 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20030528 ANDA ANDA075509 Physicians Total Care, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 54868-4802_d31c8c05-2dc2-44bc-9702-2ff81ef2ed88 54868-4802 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20030528 ANDA ANDA075509 Physicians Total Care, Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 54868-4803_7cf12d4f-b693-4e16-beaa-a6c0694c846a 54868-4803 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20030602 ANDA ANDA074823 Physicians Total Care, Inc. TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 54868-4805_ca776d20-c4c3-485a-9c31-c6eb017cc8a9 54868-4805 HUMAN PRESCRIPTION DRUG CLINDAMYCIN PHOSPHATE clindamycin phosphate SOLUTION TOPICAL 20030604 ANDA ANDA065049 Physicians Total Care, Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 54868-4806_4c539f04-059e-485a-8a8e-038ccb474b2b 54868-4806 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate LOTION TOPICAL 20030603 ANDA ANDA065067 Physicians Total Care, Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 54868-4807_0b937ee5-f2c3-48a9-87d2-f0689ff39043 54868-4807 HUMAN PRESCRIPTION DRUG Advicor niacin and lovastatin TABLET, EXTENDED RELEASE ORAL 20030603 NDA NDA021249 Physicians Total Care, Inc. LOVASTATIN; NIACIN 20; 500 mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-4810_e1db502f-fa92-4a34-9c93-68bdfb38ba85 54868-4810 HUMAN PRESCRIPTION DRUG Androgel Testosterone GEL TRANSDERMAL 20030605 NDA NDA021015 Physicians Total Care, Inc. TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 54868-4811_6b062f20-7f3a-4161-b245-309ff37ef20f 54868-4811 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20030614 ANDA ANDA075182 Physicians Total Care, Inc. ESTRADIOL .97 mg/48[USP'U] Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-4812_154afefc-0884-4dd2-98f4-a7f8f4d7e203 54868-4812 HUMAN PRESCRIPTION DRUG Cholestyramine cholestyramine POWDER, FOR SUSPENSION ORAL 20100322 ANDA ANDA077204 Physicians Total Care, Inc. CHOLESTYRAMINE 4 g/9g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 54868-4813_6b062f20-7f3a-4161-b245-309ff37ef20f 54868-4813 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20030609 ANDA ANDA075182 Physicians Total Care, Inc. ESTRADIOL 1.46 mg/48[USP'U] Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-4814_91815679-bdd9-4cf3-bd35-2593f7db8d90 54868-4814 HUMAN PRESCRIPTION DRUG Camila Norethindrone TABLET ORAL 20030619 ANDA ANDA076177 Physicians Total Care, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54868-4817_325a1e76-23a1-47e2-961c-e1c21e9a0ea7 54868-4817 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20090218 ANDA ANDA075356 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-4819_0f1ad27b-69a7-49e2-bab8-c520474fec26 54868-4819 HUMAN PRESCRIPTION DRUG EpiPen Jr epinephrine INJECTION INTRAMUSCULAR 20030617 NDA NDA019430 Physicians Total Care, Inc. EPINEPHRINE .15 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 54868-4826_b77c9d7d-6c4c-4716-b724-72e15b3ea4d2 54868-4826 HUMAN PRESCRIPTION DRUG Ketoprofen ketoprofen CAPSULE, EXTENDED RELEASE ORAL 20090623 ANDA ANDA075679 Physicians Total Care, Inc. KETOPROFEN 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-4832_f242e87a-ac72-4467-a010-7ba3c74a9987 54868-4832 HUMAN PRESCRIPTION DRUG NuvaRing etonogestrel and ethinyl estradiol INSERT, EXTENDED RELEASE VAGINAL 20111104 NDA NDA021187 Physicians Total Care, Inc. ETHINYL ESTRADIOL; ETONOGESTREL 2.7; 11.7 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-4835_03c5b3bd-62d0-4eec-8387-14ad97a93bba 54868-4835 HUMAN PRESCRIPTION DRUG Ditropan XL oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 20030625 NDA NDA020897 Physicians Total Care, Inc. OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54868-4836_b1c1aaba-8e43-4381-95f1-2c303f88b7e5 54868-4836 HUMAN PRESCRIPTION DRUG Trileptal oxcarbazepine TABLET, FILM COATED ORAL 20030707 NDA NDA021014 Physicians Total Care, Inc. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-4837_b1c1aaba-8e43-4381-95f1-2c303f88b7e5 54868-4837 HUMAN PRESCRIPTION DRUG Trileptal oxcarbazepine TABLET, FILM COATED ORAL 20030702 NDA NDA021014 Physicians Total Care, Inc. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-4842_eb12bd6a-9815-4687-8ac7-0bb533fe0137 54868-4842 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20030702 ANDA ANDA074686 Physicians Total Care, Inc. GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-4844_5f16b396-90a5-4159-bd8e-71f7f7128f34 54868-4844 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20030819 ANDA ANDA074787 Physicians Total Care, Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-4847_ff09d876-3fc3-4826-b04b-f600a4cfba83 54868-4847 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 20030703 NDA NDA020830 Physicians Total Care, Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 54868-4848_ba964216-8607-4574-8465-589a4ba3bdde 54868-4848 HUMAN PRESCRIPTION DRUG REMERON MIRTAZAPINE TABLET, FILM COATED ORAL 20010320 NDA NDA020415 Physicians Total Care, Inc. MIRTAZAPINE 15 mg/1 54868-4850_8d9ced0e-fe9a-4619-b280-744d81cdad2e 54868-4850 HUMAN PRESCRIPTION DRUG Low-Ogestrel Norgestrel and Ethinyl Estradiol KIT ORAL 20090924 ANDA ANDA075288 Physicians Total Care, Inc. 54868-4851_5b606e76-bc7b-491a-93d4-36acf0d437ae 54868-4851 HUMAN PRESCRIPTION DRUG CRYSELLE norgestrel and ethinyl estradiol KIT 20031016 ANDA ANDA075840 Physicians Total Care, Inc. 54868-4853_9be8d609-5c17-498f-9a25-c2faed75a09b 54868-4853 HUMAN PRESCRIPTION DRUG Emtriva emtricitabine CAPSULE ORAL 20030710 NDA NDA021500 Physicians Total Care, Inc. EMTRICITABINE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 54868-4857_e59e8cfa-c250-483e-b545-d37e1b4baf8b 54868-4857 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR SULFATE CAPSULE, GELATIN COATED ORAL 20030716 NDA NDA021567 Physicians Total Care, Inc. ATAZANAVIR SULFATE 150 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 54868-4858_e893a339-a5f4-4d9b-8854-4d972cbc8590 54868-4858 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20030912 ANDA ANDA076794 Physicians Total Care, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54868-4860_cc362b61-1ff0-4daf-80ee-69868519d256 54868-4860 HUMAN PRESCRIPTION DRUG ENPRESSE levonorgestrel and ethinyl estradiol KIT 20030722 ANDA ANDA075809 Physicians Total Care, Inc. 54868-4863_e1ec8388-3aeb-4259-8201-486191f06c84 54868-4863 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20030725 ANDA ANDA040440 Physicians Total Care, Inc. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-4864_790831a1-b88b-4279-b34c-4d76dd20a266 54868-4864 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 20071101 OTC MONOGRAPH NOT FINAL part343 Physicians Total Care, Inc. ASPIRIN 81 mg/1 54868-4866_28327f6d-9226-4266-bfb2-7a89715a978b 54868-4866 HUMAN PRESCRIPTION DRUG Prempro conjugated estrogens and medroxyprogesterone acetate TABLET, SUGAR COATED ORAL 20030725 NDA NDA020527 Physicians Total Care, Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .45; 1.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54868-4867_5f3d6306-fa1b-4280-9b1f-fd6f9cedc97c 54868-4867 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050329 NDA NDA020381 Physicians Total Care, Inc. NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 54868-4868_02240487-411f-4d1c-94b4-ce9958df78f3 54868-4868 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem CAPSULE, EXTENDED RELEASE ORAL 20040524 ANDA ANDA074984 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-4869_714d8082-a99d-4580-9ff6-2c569bbbda65 54868-4869 HUMAN PRESCRIPTION DRUG ATACAND HCT Candesartan cilexetil and Hydrochlorothiazide TABLET ORAL 20031113 NDA NDA021093 Physicians Total Care, Inc. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4870_8a1277c4-9a11-4cc9-8a6b-aea181d8c75c 54868-4870 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20030730 NDA NDA020364 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-4871_49c0d1e0-b392-4d27-a762-2f27405a5be3 54868-4871 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20030806 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54868-4873_c6d171e1-6765-4e8a-833e-7b071efd94ed 54868-4873 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20030806 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54868-4875_62a34e85-f86f-407b-9809-8b33c073b33c 54868-4875 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030811 NDA AUTHORIZED GENERIC NDA019684 Physicians Total Care, Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54868-4876_1680e527-98c3-4972-ac07-86a70a83fc18 54868-4876 HUMAN PRESCRIPTION DRUG Guanfacine guanfacine hydrochloride TABLET ORAL 20030731 ANDA ANDA074796 Physicians Total Care, Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54868-4878_c21cfbda-8878-4586-b356-77ba949bd877 54868-4878 HUMAN PRESCRIPTION DRUG Elidel pimecrolimus CREAM TOPICAL 20031030 NDA NDA021302 Physicians Total Care, Inc. PIMECROLIMUS 10 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 54868-4879_f0646bea-d356-441c-8b53-a89245a3762c 54868-4879 HUMAN PRESCRIPTION DRUG Cenestin synthetic conjugated estrogens, A TABLET, FILM COATED ORAL 20030811 NDA NDA020992 Physicians Total Care, Inc. ESTROGENS, CONJUGATED SYNTHETIC A .625 mg/1 54868-4883_d3ca750e-3050-4214-aea8-cffa33a2d61a 54868-4883 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET ORAL 20040427 ANDA ANDA078454 Physicians Total Care, Inc. MOEXIPRIL HYDROCHLORIDE 15 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-4885_16a9da03-d763-4c90-a175-7739c59b0d16 54868-4885 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20030806 NDA NDA021286 Physicians Total Care, Inc. OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-4892_e4fe38fa-19f0-4476-9723-e51767dfeb78 54868-4892 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20040322 ANDA ANDA075932 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 54868-4894_541e86b5-ee7a-4f93-b67b-50611e8c4798 54868-4894 HUMAN PRESCRIPTION DRUG Plan B Levonorgestrel TABLET ORAL 20030814 NDA NDA021045 Physicians Total Care, Inc. LEVONORGESTREL .75 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 54868-4895_d31c8c05-2dc2-44bc-9702-2ff81ef2ed88 54868-4895 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20030814 ANDA ANDA075509 Physicians Total Care, Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 54868-4897_219741f7-4f2b-4db1-aaca-4dc0482310df 54868-4897 HUMAN PRESCRIPTION DRUG PROVIGIL MODAFINIL TABLET ORAL 20040119 NDA NDA020717 Physicians Total Care, Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 54868-4898_e893a339-a5f4-4d9b-8854-4d972cbc8590 54868-4898 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20030819 ANDA ANDA076794 Physicians Total Care, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54868-4899_5f3d6306-fa1b-4280-9b1f-fd6f9cedc97c 54868-4899 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090727 NDA NDA020381 Physicians Total Care, Inc. NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 54868-4903_5f16b396-90a5-4159-bd8e-71f7f7128f34 54868-4903 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20040825 ANDA ANDA074787 Physicians Total Care, Inc. LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-4904_78f83075-c908-4385-8690-9ff0a573ff17 54868-4904 HUMAN PRESCRIPTION DRUG Lotensin HCT benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20030829 NDA NDA020033 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4907_9785289c-e261-4b55-97bd-2e0e506c5525 54868-4907 HUMAN PRESCRIPTION DRUG Halobetasol Propionate halobetasol propionate CREAM TOPICAL 20050525 ANDA ANDA077123 Physicians Total Care, Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4909_30425296-6515-4eca-9207-6886806a389c 54868-4909 HUMAN PRESCRIPTION DRUG PREVPAC lansoprazole, amoxicillin and clarithromycin KIT 20050520 NDA NDA050757 Physicians Total Care, Inc. 54868-4910_ab9a95a4-6432-490d-b93e-38cfdd45fc6a 54868-4910 HUMAN PRESCRIPTION DRUG ENTOCORT EC Budesonide CAPSULE ORAL 20060522 NDA NDA021324 Physicians Total Care, Inc. BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4912_898c5e2b-1c01-486f-a82e-0345fd3c5575 54868-4912 HUMAN PRESCRIPTION DRUG MIRAPEX pramipexole dihydrochloride TABLET ORAL 20030904 NDA NDA020667 Physicians Total Care, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 54868-4916_430621f8-c3cb-44a1-88f4-b13adbba4bfd 54868-4916 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 20070527 NDA NDA020241 Physicians Total Care, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 54868-4917_55569cb4-d14c-46a3-a7b4-549e5e9e1d4f 54868-4917 HUMAN OTC DRUG Senna/Docusate Sodium Docusate sodium and Sennosides TABLET, FILM COATED ORAL 20030911 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 54868-4918_dba74198-1341-41e1-9f6e-a756104c434b 54868-4918 HUMAN PRESCRIPTION DRUG Levothroid LEVOTHYROXINE SODIUM TABLET ORAL 20030912 NDA NDA021116 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-4920_0743df29-7a29-4a45-85a4-3b2f6bdc91d8 54868-4920 HUMAN PRESCRIPTION DRUG Vivelle Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 20030923 NDA NDA020538 Physicians Total Care, Inc. ESTRADIOL .0375 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-4921_5f16b396-90a5-4159-bd8e-71f7f7128f34 54868-4921 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20040506 ANDA ANDA074787 Physicians Total Care, Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-4928_45f86d7d-70c1-4f0f-b624-52973dcb4da6 54868-4928 HUMAN PRESCRIPTION DRUG Ciprodex ciprofloxacin and dexamethasone SUSPENSION AURICULAR (OTIC) 20040921 NDA NDA021537 Physicians Total Care, Inc. CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE 3; 1 mg/mL; mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-4932_2effcdad-6bba-4e82-a3d2-9cacf46ecd1c 54868-4932 HUMAN PRESCRIPTION DRUG Betaxolol Betaxolol TABLET, FILM COATED ORAL 20031007 ANDA ANDA075541 Physicians Total Care, Inc. BETAXOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-4934_2785c2fd-f22a-43aa-a781-e1218be9a70c 54868-4934 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20060111 NDA NDA020702 Physicians Total Care, Inc ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-4935_97320ca9-fbbf-4536-a667-24e225e609fb 54868-4935 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20031008 NDA NDA021515 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 54868-4937_325a1e76-23a1-47e2-961c-e1c21e9a0ea7 54868-4937 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20081015 ANDA ANDA075356 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-4938_325a1e76-23a1-47e2-961c-e1c21e9a0ea7 54868-4938 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20040407 ANDA ANDA075356 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-4939_fe0547b0-9f3b-4c64-901a-66999401e26d 54868-4939 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20040119 ANDA ANDA076286 Physicians Total Care, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54868-4947_447e39ea-78d1-47f1-80f0-a95bdc4ed962 54868-4947 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20031030 NDA NDA021035 Physicians Total Care, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-4948_e471506d-cd02-4fcc-acbd-bb881d13561a 54868-4948 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20040107 ANDA ANDA040517 Physicians Total Care, Inc. METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-4950_c6d171e1-6765-4e8a-833e-7b071efd94ed 54868-4950 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20031021 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54868-4951_96632530-85c4-4b9f-a751-42981e9a0d4c 54868-4951 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20031103 ANDA ANDA065063 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54868-4956_18a657cc-cd61-4d7d-8def-54c6ce508cd4 54868-4956 HUMAN PRESCRIPTION DRUG Denavir penciclovir CREAM TOPICAL 20031113 NDA NDA020629 Physicians Total Care, Inc. PENCICLOVIR 10 mg/g DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 54868-4957_1c304460-91d1-4710-bcc9-8c9621b36a0b 54868-4957 HUMAN PRESCRIPTION DRUG Concerta Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20031113 NDA NDA021121 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-4958_eca9dbf4-887f-4b07-87ef-e9544fa84c4d 54868-4958 HUMAN PRESCRIPTION DRUG Mupirocin mupirocin OINTMENT TOPICAL 20031205 ANDA ANDA065192 Physicians Total Care, Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 54868-4959_79aec30f-078c-407a-b179-fa5d3e9098d2 54868-4959 HUMAN PRESCRIPTION DRUG Depakote divalproex sodium TABLET, EXTENDED RELEASE ORAL 20031118 NDA NDA021168 Physicians Total Care, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 54868-4961_a8e03fcb-e9fd-40e2-8516-febf36072b05 54868-4961 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20031119 NDA NDA020639 Physicians Total Care, Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 54868-4963_ec82c251-eebc-4210-9920-6cd5a827a177 54868-4963 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20031125 NDA NDA021366 Physicians Total Care, Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-4964_fe0547b0-9f3b-4c64-901a-66999401e26d 54868-4964 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20040303 ANDA ANDA076286 Physicians Total Care, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54868-4965_775e2b02-fe2c-4563-a982-c57f34996cc7 54868-4965 HUMAN PRESCRIPTION DRUG AVANDAMET rosiglitazone maleate and metformin hydrochloride TABLET, FILM COATED ORAL 20031204 NDA NDA021410 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 500; 2 mg/1; mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-4967_6ae08a69-c0f2-4b2c-8254-c90fb9a77c89 54868-4967 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20040127 NDA NDA021400 Physicians Total Care, Inc. VARDENAFIL HYDROCHLORIDE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 54868-4968_e899df9b-095c-4c16-895f-3307f9810383 54868-4968 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031211 NDA NDA021368 Physicians Total Care, Inc. TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 54868-4969_e387fd18-7c90-431b-8e9b-b381edb43c49 54868-4969 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, FILM COATED ORAL 20040107 ANDA ANDA078273 Physicians Total Care, Inc. HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-4970_02240487-411f-4d1c-94b4-ce9958df78f3 54868-4970 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem CAPSULE, EXTENDED RELEASE ORAL 20091218 ANDA ANDA074984 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-4971_3e9b0b41-65ab-47e1-8790-cccf368f68aa 54868-4971 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 20050802 NDA NDA020634 Physicians Total Care, Inc. LEVOFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54868-4972_37f4de47-6e86-480a-912a-ccdf4ebc143a 54868-4972 HUMAN PRESCRIPTION DRUG Foradil formoterol fumarate CAPSULE RESPIRATORY (INHALATION) 20040528 NDA NDA020831 Physicians Total Care, Inc. FORMOTEROL FUMARATE 12 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 54868-4973_faad3ce3-e3a8-415b-9396-d22c840fab0d 54868-4973 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20090529 NDA NDA022207 Physicians Total Care, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-4974_b794d466-79aa-4a4a-9fd3-f6ffc7037b72 54868-4974 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20040113 ANDA ANDA040400 Physicians Total Care, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 54868-4976_a0361f5f-c7f6-4907-a525-5a953d70150f 54868-4976 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED ORAL 20050725 ANDA ANDA076604 Physicians Total Care, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 54868-4977_c92105c7-4189-49dd-b3c2-88f37b80b422 54868-4977 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20040614 ANDA ANDA076007 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-4980_3b9af72f-c970-4248-b050-fc675fbd5825 54868-4980 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET ORAL 20080116 ANDA ANDA077712 Physicians Total Care, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-4981_8ea73dd1-dfe3-4628-940f-16587e605fcb 54868-4981 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20040116 NDA NDA020616 Physicians Total Care, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-4983_3b9af72f-c970-4248-b050-fc675fbd5825 54868-4983 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET ORAL 20091218 ANDA ANDA077712 Physicians Total Care, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-4984_6ae08a69-c0f2-4b2c-8254-c90fb9a77c89 54868-4984 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20040305 NDA NDA021400 Physicians Total Care, Inc. VARDENAFIL HYDROCHLORIDE 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 54868-4985_c3768a3d-739f-4a72-a32f-3361beed0c8a 54868-4985 HUMAN PRESCRIPTION DRUG Celexa citalopram hydrobromide TABLET ORAL 20040130 NDA NDA020822 Physicians Total Care, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-4986_16a9da03-d763-4c90-a175-7739c59b0d16 54868-4986 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20040130 NDA NDA021286 Physicians Total Care, Inc. OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-4987_2f5eb9a3-64c5-4790-89d0-7a6c98e5f37b 54868-4987 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20040130 ANDA ANDA065308 Physicians Total Care, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54868-4988_845f8e7d-6ebc-4986-8cec-a4b58a0d1a69 54868-4988 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20040130 ANDA ANDA076467 Physicians Total Care, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-4989_faa17132-4835-45ce-b056-0057510caa3f 54868-4989 HUMAN PRESCRIPTION DRUG Testim testosterone GEL TRANSDERMAL 20040129 NDA NDA021454 Physicians Total Care, Inc. TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 54868-4990_de49eae2-62de-4a99-be85-b5b31aaa0ddb 54868-4990 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20040129 ANDA ANDA065066 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54868-4991_3ea83636-fc0a-4085-8693-f0f1947b5454 54868-4991 HUMAN OTC DRUG ACETAMINOPHEN pain reliever/fever reducer acetaminophen SUPPOSITORY RECTAL 20040203 ANDA ANDA070608 Physicians Total Care, Inc. ACETAMINOPHEN 650 mg/1 54868-4992_e5f3b0c9-1c83-47b1-8de0-375ea9719d22 54868-4992 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20040205 NDA AUTHORIZED GENERIC NDA020401 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-4997_10e409a4-8539-43f5-9081-ec58e3cbda65 54868-4997 HUMAN PRESCRIPTION DRUG Pregnyl CHORIOGONADOTROPIN ALFA KIT 20100817 NDA NDA017692 Physicians Total Care, Inc. 54868-5000_c6d0f6d9-ea38-469c-b961-0fce271fb349 54868-5000 HUMAN PRESCRIPTION DRUG ARIMIDEX Anastrozole TABLET ORAL 20040219 NDA NDA020541 Physicians Total Care, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 54868-5001_4bea215c-7140-4209-bc87-04f71058d569 54868-5001 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040517 ANDA ANDA076211 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-5002_ce005228-bed3-4940-831b-c7f8b8256d9f 54868-5002 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate LOTION TOPICAL 20041109 ANDA ANDA018866 Physicians Total Care, Inc. BETAMETHASONE VALERATE 1 mg/mL 54868-5005_6f09d2d9-19e9-4068-9dce-33601a0425ec 54868-5005 HUMAN PRESCRIPTION DRUG Cyclophosphamide Cyclophosphamide TABLET ORAL 19990817 ANDA ANDA040032 Physicians Total Care, Inc. CYCLOPHOSPHAMIDE 50 mg/1 54868-5009_6b062f20-7f3a-4161-b245-309ff37ef20f 54868-5009 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20081211 ANDA ANDA075182 Physicians Total Care, Inc. ESTRADIOL 1.94 mg/48[USP'U] Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-5010_97320ca9-fbbf-4536-a667-24e225e609fb 54868-5010 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20040302 NDA NDA021515 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 54868-5011_0a9b2fd9-dfc7-45f1-b849-10caf5e9aee2 54868-5011 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, EXTENDED RELEASE ORAL 20040302 ANDA ANDA075910 Physicians Total Care, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-5013_802a50e4-5f27-474c-9680-863ecf00920b 54868-5013 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol Fumarate TABLET, FILM COATED ORAL 20090723 ANDA ANDA075644 Physicians Total Care, Inc. BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-5015_91fda3d6-bdfe-4dcd-84ea-32817ce41a78 54868-5015 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20040309 ANDA ANDA040353 Physicians Total Care, Inc. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 54868-5020_9166ec18-da24-4f12-b446-dcf2dcc9d3ca 54868-5020 HUMAN PRESCRIPTION DRUG Neupogen filgrastim INJECTION, SOLUTION INTRAVENOUS 20040311 BLA BLA103353 Physicians Total Care, Inc. FILGRASTIM 300 ug/.5mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] 54868-5021_01773720-eb77-4c73-880c-a727561fafc7 54868-5021 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20040315 ANDA ANDA077739 Physicians Total Care, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-5022_2f5eb9a3-64c5-4790-89d0-7a6c98e5f37b 54868-5022 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20040317 ANDA ANDA065308 Physicians Total Care, Inc. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54868-5023_e893a339-a5f4-4d9b-8854-4d972cbc8590 54868-5023 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040317 ANDA ANDA076794 Physicians Total Care, Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54868-5024_a1a2b20f-2261-4d4f-8bd8-bac39ed027bf 54868-5024 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20081014 ANDA ANDA040545 Physicians Total Care, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-5028_41c5a38a-eec9-4379-b253-cd06c8fd6012 54868-5028 HUMAN PRESCRIPTION DRUG Tri-Sprintec norgestimate and ethinyl estradiol KIT 20040326 ANDA ANDA075808 Physicians Total Care, Inc. 54868-5030_bd08e4c9-d70e-4c99-bb73-1ba32248fbd9 54868-5030 HUMAN PRESCRIPTION DRUG DIFFERIN adapalene GEL TOPICAL 20040707 NDA NDA020380 Physicians Total Care, Inc. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-5031_06466570-1478-4d94-934e-11d97c8b92c5 54868-5031 HUMAN PRESCRIPTION DRUG Velivet Triphasic Regimen Desogestrel and Ethinyl Estradiol KIT 20040326 ANDA ANDA076455 Physicians Total Care, Inc. 54868-5033_f346e5da-59f8-462a-8d84-271d1f65f579 54868-5033 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20040329 NDA AUTHORIZED GENERIC NDA019594 Physicians Total Care, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 54868-5034_d86d8b95-1d16-4914-879b-8e0d9e3ba1cc 54868-5034 HUMAN PRESCRIPTION DRUG Antabuse Disulfiram TABLET ORAL 20040330 ANDA ANDA088482 Physicians Total Care, Inc. DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] 54868-5039_af1dad81-bf25-42c9-933f-e1aab296f738 54868-5039 HUMAN PRESCRIPTION DRUG Amnesteem isotretinoin CAPSULE ORAL 20101102 ANDA ANDA075945 Physicians Total Care, Inc. ISOTRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-5040_5d6870ab-c968-429a-9459-bc6f3fa17ea2 54868-5040 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20050414 ANDA ANDA065062 Physicians Total Care, Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 54868-5041_af1dad81-bf25-42c9-933f-e1aab296f738 54868-5041 HUMAN PRESCRIPTION DRUG Amnesteem isotretinoin CAPSULE ORAL 20090914 ANDA ANDA075945 Physicians Total Care, Inc. ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-5042_e711d6ee-835a-4451-b9b6-4fb3ecb5161e 54868-5042 HUMAN PRESCRIPTION DRUG Econazole Nitrate econazole nitrate CREAM TOPICAL 20040519 ANDA ANDA076075 Physicians Total Care, Inc. ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 54868-5043_af1dad81-bf25-42c9-933f-e1aab296f738 54868-5043 HUMAN PRESCRIPTION DRUG Amnesteem isotretinoin CAPSULE ORAL 20090714 ANDA ANDA075945 Physicians Total Care, Inc. ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-5046_9269c2d5-33df-4a96-bbc2-83c4ebeeba15 54868-5046 HUMAN PRESCRIPTION DRUG Uroxatral alfuzosin hydrochloride TABLET, EXTENDED RELEASE ORAL 20040622 NDA NDA021287 Physicians Total Care, Inc. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 54868-5047_28327f6d-9226-4266-bfb2-7a89715a978b 54868-5047 HUMAN PRESCRIPTION DRUG Prempro conjugated estrogens and medroxyprogesterone acetate TABLET, SUGAR COATED ORAL 20040408 NDA NDA020527 Physicians Total Care, Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .3; 1.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54868-5049_2b005fc8-215f-4e39-9071-f438704b3e0d 54868-5049 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SPRAY, METERED NASAL 20040412 ANDA ANDA076103 Physicians Total Care, Inc. IPRATROPIUM BROMIDE 42 ug/1 54868-5050_4efaae7a-6bfd-4ff3-bdad-384c7a414047 54868-5050 HUMAN PRESCRIPTION DRUG Desonide Desonide LOTION TOPICAL 20040517 ANDA ANDA072354 Physicians Total Care, Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5052_93455f35-fd9c-490d-aca4-b2becdebe5f1 54868-5052 HUMAN PRESCRIPTION DRUG NICOTROL nicotine INHALANT RESPIRATORY (INHALATION) 20040804 NDA NDA020714 Physicians Total Care, Inc. NICOTINE 4 mg/1 Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient] 54868-5054_c50edaa2-4f73-4ed5-a237-752242c00736 54868-5054 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, EXTENDED RELEASE ORAL 20040426 ANDA ANDA075295 Physicians Total Care, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-5055_083f09ed-bcec-4d2d-8a30-09c1b95e4708 54868-5055 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040427 ANDA ANDA076139 Physicians Total Care, Inc. FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-5056_20d39fb1-12c2-4010-8010-ef55d8f48a08 54868-5056 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20040427 ANDA ANDA076466 Physicians Total Care, Inc. METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 54868-5058_b8427898-2a74-41d0-aed2-4839df76e139 54868-5058 HUMAN PRESCRIPTION DRUG Cytomel liothyronine sodium TABLET ORAL 20040503 NDA NDA010379 Physicians Total Care, Inc. LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 54868-5064_083f09ed-bcec-4d2d-8a30-09c1b95e4708 54868-5064 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040518 ANDA ANDA076139 Physicians Total Care, Inc. FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-5067_fed8d510-c787-407c-8748-a41c6e8cc4a0 54868-5067 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20090129 ANDA ANDA084903 Physicians Total Care, Inc. PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-5070_26b73aa5-c8dc-449d-9162-fb10dcc110e8 54868-5070 HUMAN PRESCRIPTION DRUG Glucagon glucagon KIT 20040524 NDA NDA020928 Physicians Total Care, Inc. 54868-5071_bff287d0-e71f-4fe8-bf73-5100a2432a2f 54868-5071 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 20040524 ANDA ANDA075319 Physicians Total Care, Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 54868-5072_8549813a-3660-43e2-ae37-674c4c9f7ef2 54868-5072 HUMAN PRESCRIPTION DRUG Astelin Azelastine Hydrochloride SPRAY, METERED NASAL 20040525 NDA NDA020114 Physicians Total Care, Inc. AZELASTINE HYDROCHLORIDE 137 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 54868-5074_87b9641a-07be-4e3d-84a8-a9f2b8c19a77 54868-5074 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20040630 ANDA ANDA076278 Physicians Total Care, Inc. FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] 54868-5075_853c3980-7c9b-4c59-805f-5e5ff232a59a 54868-5075 HUMAN PRESCRIPTION DRUG Benicar Hct olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20040601 NDA NDA021532 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5077_60b11c09-e7ec-4f59-97b9-8a4237840578 54868-5077 HUMAN PRESCRIPTION DRUG Cozaar losartan potassium TABLET, FILM COATED ORAL 20040602 NDA NDA020386 Physicians Total Care, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-5078_853c3980-7c9b-4c59-805f-5e5ff232a59a 54868-5078 HUMAN PRESCRIPTION DRUG Benicar Hct olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20040602 NDA NDA021532 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5079_4bea215c-7140-4209-bc87-04f71058d569 54868-5079 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040825 ANDA ANDA076211 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-5080_325a1e76-23a1-47e2-961c-e1c21e9a0ea7 54868-5080 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20040817 ANDA ANDA075356 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-5081_02240487-411f-4d1c-94b4-ce9958df78f3 54868-5081 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem CAPSULE, EXTENDED RELEASE ORAL 20040603 ANDA ANDA074984 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-5082_7c4c1776-6fe6-419a-9eb6-3e365693efa3 54868-5082 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20070917 NDA NDA021283 Physicians Total Care, Inc. VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-5085_ec82c251-eebc-4210-9920-6cd5a827a177 54868-5085 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20040607 NDA NDA021366 Physicians Total Care, Inc. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5095_802a50e4-5f27-474c-9680-863ecf00920b 54868-5095 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol Fumarate TABLET, FILM COATED ORAL 20090807 ANDA ANDA075644 Physicians Total Care, Inc. BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-5099_e9a7e3b9-6030-4189-ba01-32261559e4f6 54868-5099 HUMAN PRESCRIPTION DRUG Mavik Trandolapril TABLET ORAL 20040625 NDA NDA020528 Physicians Total Care, Inc. TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-5100_13b193d2-e076-491d-b20c-c5c8d7d8a47c 54868-5100 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET ORAL 20090723 ANDA ANDA076486 Physicians Total Care, Inc. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5101_db05df82-8297-4bea-9036-dc5d651cac72 54868-5101 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20100225 ANDA ANDA065378 Physicians Total Care, Inc. AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54868-5103_e1ec8388-3aeb-4259-8201-486191f06c84 54868-5103 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20040707 ANDA ANDA040440 Physicians Total Care, Inc. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-5104_20d39fb1-12c2-4010-8010-ef55d8f48a08 54868-5104 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20040706 ANDA ANDA076732 Physicians Total Care, Inc. METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 54868-5108_199662a5-c92a-43ca-88ff-38e30bc6c3b9 54868-5108 HUMAN PRESCRIPTION DRUG Humalog Insulin lispro INJECTION, SOLUTION SUBCUTANEOUS 20050502 NDA NDA020563 Physicians Total Care, Inc. INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 54868-5109_ca587c20-50ac-4f59-96f6-5b1e1505722f 54868-5109 HUMAN PRESCRIPTION DRUG Spiriva tiotropium bromide monohydrate CAPSULE ORAL; RESPIRATORY (INHALATION) 20040714 NDA NDA021395 Physicians Total Care, Inc. TIOTROPIUM BROMIDE MONOHYDRATE 18 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 54868-5110_83416fe4-d127-4a91-b127-29c37a6979f2 54868-5110 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20040715 OTC MONOGRAPH FINAL part331 Physicians Total Care, Inc. MAGNESIUM OXIDE 400 mg/1 54868-5112_cf63553d-cb67-44c0-8c5f-44683f9a30ac 54868-5112 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20040728 NDA NDA020164 Physicians Total Care, Inc. ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 54868-5113_c14d08c7-47b9-4209-9adb-0f8500f29564 54868-5113 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 20041006 ANDA ANDA074821 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5114_c00a9dd4-45c6-4de5-bfb7-9abdaac6bbcd 54868-5114 HUMAN PRESCRIPTION DRUG Avodart dutasteride CAPSULE, LIQUID FILLED ORAL 20040716 NDA NDA021319 Physicians Total Care, Inc. DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 54868-5118_8e25e51e-51b0-48d2-b47a-34189bcfec7c 54868-5118 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate TABLET, FILM COATED ORAL 20040714 NDA NDA020132 Physicians Total Care, Inc. SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 54868-5119_20d39fb1-12c2-4010-8010-ef55d8f48a08 54868-5119 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20040720 ANDA ANDA076466 Physicians Total Care, Inc. METOLAZONE 10 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 54868-5121_b0edb786-44c1-43ea-afc0-78df4970ce86 54868-5121 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20050523 ANDA ANDA040863 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 54868-5124_9061bcf0-3933-4af1-8a72-71602eb59c0c 54868-5124 HUMAN PRESCRIPTION DRUG VANIQA eflornithine hydrochloride CREAM TOPICAL 20040726 NDA NDA021145 Physicians Total Care, Inc. EFLORNITHINE HYDROCHLORIDE 139 mg/g Antiprotozoal [EPC],Decarboxylase Inhibitor [EPC],Decarboxylase Inhibitors [MoA] 54868-5126_3056bc9b-abd8-4f5a-bb6b-4acb629afac5 54868-5126 HUMAN PRESCRIPTION DRUG Detrol LA tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20040903 NDA NDA021228 Physicians Total Care, Inc. TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54868-5129_3d4b67bb-e159-4b4f-aa17-624515cd639f 54868-5129 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 20040812 NDA AUTHORIZED GENERIC NDA019949 Physicians Total Care, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 54868-5130_fe5d59ac-8d14-4dc8-9b84-3e0c90e0da7a 54868-5130 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20040809 ANDA ANDA076673 Physicians Total Care, Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54868-5132_c50edaa2-4f73-4ed5-a237-752242c00736 54868-5132 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, EXTENDED RELEASE ORAL 20040810 ANDA ANDA075295 Physicians Total Care, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-5139_3883e227-acaf-4daf-8319-6dc2fb5b6293 54868-5139 HUMAN PRESCRIPTION DRUG Sonata zaleplon CAPSULE ORAL 20070905 NDA NDA020859 Physicians Total Care, Inc. ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 54868-5140_bdecce86-e035-472d-8131-180414c321fe 54868-5140 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20040816 NDA NDA021303 Physicians Total Care, Inc. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-5141_f38902d1-0634-4845-beb8-334086f7a64c 54868-5141 HUMAN PRESCRIPTION DRUG Truvada emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20040802 NDA NDA021752 Physicians Total Care, Inc. EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 54868-5142_bdecce86-e035-472d-8131-180414c321fe 54868-5142 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20040823 NDA NDA021303 Physicians Total Care, Inc. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-5143_37a9009f-2b28-49bc-9ca7-47193bb56554 54868-5143 HUMAN PRESCRIPTION DRUG Aggrenox aspirin and dipyridamole CAPSULE ORAL 20040824 NDA NDA020884 Physicians Total Care, Inc. ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 54868-5144_3d4b67bb-e159-4b4f-aa17-624515cd639f 54868-5144 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 20040812 NDA AUTHORIZED GENERIC NDA019949 Physicians Total Care, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 54868-5146_b794d466-79aa-4a4a-9fd3-f6ffc7037b72 54868-5146 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20040902 ANDA ANDA040409 Physicians Total Care, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 54868-5148_613f1eee-3018-45a8-a196-164c9d37a732 54868-5148 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20110102 ANDA ANDA076345 Physicians Total Care, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-5157_775e2b02-fe2c-4563-a982-c57f34996cc7 54868-5157 HUMAN PRESCRIPTION DRUG AVANDAMET rosiglitazone maleate and metformin hydrochloride TABLET, FILM COATED ORAL 20060825 NDA NDA021410 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 500; 4 mg/1; mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-5160_20fbadcf-d7c0-4336-b61f-8980c79e35cb 54868-5160 HUMAN PRESCRIPTION DRUG POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 POWDER ORAL 20041007 ANDA ANDA076652 Physicians Total Care, Inc. POLYETHYLENE GLYCOL 3350 1 g/g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 54868-5162_2babd42d-0704-4744-91e6-ff80911874d5 54868-5162 HUMAN PRESCRIPTION DRUG BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE codeine phosphate, butalbital, caffeine, and acetaminophen capsule CAPSULE ORAL 20090706 ANDA ANDA020232 Physicians Total Care, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 54868-5165_d20fb9f1-0b8c-413b-b733-030857928fd3 54868-5165 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium SUSPENSION ORAL 20081013 ANDA ANDA065358 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54868-5166_262588dd-98d4-4859-8ea6-032744c9a832 54868-5166 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20060829 ANDA ANDA078428 Physicians Total Care, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-5167_908a86d2-aa73-435f-8a10-843670316df1 54868-5167 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20041122 ANDA ANDA040405 Physicians Total Care, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 54868-5168_06c6c6a9-b6d8-4107-b2b0-494705ef260d 54868-5168 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide SYRUP ORAL 20071107 ANDA ANDA040613 Physicians Total Care, Inc. HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5; 5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] CIII 54868-5170_853c3980-7c9b-4c59-805f-5e5ff232a59a 54868-5170 HUMAN PRESCRIPTION DRUG Benicar Hct olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20041015 NDA NDA021532 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5; 20 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5171_ce3e7997-b925-4b07-994e-b2e699e0d3a1 54868-5171 HUMAN PRESCRIPTION DRUG Ketek telithromycin TABLET, FILM COATED ORAL 20041027 NDA NDA021144 Physicians Total Care, Inc. TELITHROMYCIN 400 mg/1 Ketolide Antibacterial [EPC],Ketolides [Chemical/Ingredient] 54868-5175_de49eae2-62de-4a99-be85-b5b31aaa0ddb 54868-5175 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20050316 ANDA ANDA065066 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54868-5178_dadf8ed3-b155-4449-a74e-1ebdf9b10a06 54868-5178 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20080118 ANDA ANDA077031 Physicians Total Care, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-5179_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-5179 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20041111 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5180_3a76a4d0-bd0f-409e-adf0-0cbaae53243c 54868-5180 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20050401 ANDA ANDA079234 Physicians Total Care, Inc. TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 54868-5182_083f09ed-bcec-4d2d-8a30-09c1b95e4708 54868-5182 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20041118 ANDA ANDA076139 Physicians Total Care, Inc. FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-5183_3f8e1db1-b2e1-4b1f-a1a9-863715d303a2 54868-5183 HUMAN PRESCRIPTION DRUG Terconazole terconazole CREAM VAGINAL 20041118 ANDA ANDA075953 Physicians Total Care, Inc. TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 54868-5185_613f1eee-3018-45a8-a196-164c9d37a732 54868-5185 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20041119 ANDA ANDA076345 Physicians Total Care, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-5186_641276ef-a0de-4184-ad36-030a96acb7d1 54868-5186 HUMAN PRESCRIPTION DRUG PACERONE amiodarone hydrochloride TABLET ORAL 20081022 ANDA ANDA075135 Physicians Total Care, Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 54868-5187_03da19ea-d024-469b-a606-892170bb9ccd 54868-5187 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20041119 NDA NDA021687 Physicians Total Care, Inc. EZETIMIBE; SIMVASTATIN 10; 20 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5188_723ef500-4b12-4d0d-b926-ae59e21fe0e0 54868-5188 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051114 ANDA ANDA077270 Physicians Total Care, Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-5189_03da19ea-d024-469b-a606-892170bb9ccd 54868-5189 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20041119 NDA NDA021687 Physicians Total Care, Inc. EZETIMIBE; SIMVASTATIN 10; 40 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5190_1464cdb0-3223-4e7b-81fb-c9f1b4a57f0f 54868-5190 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 20041129 NDA NDA020505 Physicians Total Care, Inc. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-5192_334e3947-0fd2-49b0-ba27-cc2a8ab32e47 54868-5192 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20091123 NDA NDA021427 Physicians Total Care, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-5194_2b5040b4-a52f-441b-a299-fec130b3d826 54868-5194 HUMAN PRESCRIPTION DRUG LIDOCAINE AND PRILOCAINE Lidocaine and Prilocaine CREAM TOPICAL 20041210 ANDA ANDA076453 Physicians Total Care, Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 54868-5195_884529eb-1b8a-4891-b377-e28ad5cf0bdd 54868-5195 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20041216 ANDA ANDA077662 Physicians Total Care, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-5197_f25888eb-e871-4f73-a93d-cfda73a099c2 54868-5197 HUMAN PRESCRIPTION DRUG Felodipine felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050322 ANDA ANDA075896 Physicians Total Care, Inc. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54868-5200_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-5200 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20041227 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5201_ca8c3e5e-b0aa-498e-becd-02cdb41714df 54868-5201 HUMAN PRESCRIPTION DRUG NovoLog Mix 70/30 insulin aspart INJECTION, SUSPENSION SUBCUTANEOUS 20041228 NDA NDA021172 Physicians Total Care, Inc. INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 54868-5202_749ca7b2-0317-497a-bc36-167f5c02dbf3 54868-5202 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20060131 NDA NDA021436 Physicians Total Care, Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] 54868-5203_044e1d60-69dd-4322-91bd-c16f69f3255c 54868-5203 HUMAN PRESCRIPTION DRUG Tricor fenofibrate TABLET ORAL 20041229 NDA NDA021656 Physicians Total Care, Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 54868-5204_4bea215c-7140-4209-bc87-04f71058d569 54868-5204 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20050105 ANDA ANDA076211 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-5208_e5f3b0c9-1c83-47b1-8de0-375ea9719d22 54868-5208 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050117 NDA AUTHORIZED GENERIC NDA020401 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-5209_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-5209 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20050118 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5210_845f8e7d-6ebc-4986-8cec-a4b58a0d1a69 54868-5210 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050118 ANDA ANDA076467 Physicians Total Care, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-5211_d1a436e2-b35a-4bf2-9386-da4190a4c03e 54868-5211 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20050419 ANDA ANDA065061 Physicians Total Care, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 54868-5213_943821b5-8382-43e2-a18b-ac8e9cde746e 54868-5213 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20050225 ANDA ANDA040256 Physicians Total Care, Inc. PREDNISONE 5 mg/1 54868-5214_fec9fd56-f868-4a25-8558-75afcc8e2005 54868-5214 HUMAN PRESCRIPTION DRUG AMILORIDE HYDROCHLORIDE amiloride hydrochloride TABLET ORAL 20050128 NDA NDA018200 Physicians Total Care, Inc. AMILORIDE HYDROCHLORIDE 5 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 54868-5215_334e3947-0fd2-49b0-ba27-cc2a8ab32e47 54868-5215 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20080428 NDA NDA021427 Physicians Total Care, Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-5216_7321055b-ecac-44c6-a253-b34d65893a53 54868-5216 HUMAN PRESCRIPTION DRUG Nystatin nystatin POWDER TOPICAL 20050127 ANDA ANDA064118 Physicians Total Care, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 54868-5217_820acf57-1076-4cf1-ab84-1b3fe2cf5b53 54868-5217 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20050321 ANDA ANDA077336 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-5218_6f09d2d9-19e9-4068-9dce-33601a0425ec 54868-5218 HUMAN PRESCRIPTION DRUG Cyclophosphamide Cyclophosphamide TABLET ORAL 19990817 ANDA ANDA040032 Physicians Total Care, Inc. CYCLOPHOSPHAMIDE 25 mg/1 54868-5219_884529eb-1b8a-4891-b377-e28ad5cf0bdd 54868-5219 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20050214 ANDA ANDA077662 Physicians Total Care, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-5224_044e1d60-69dd-4322-91bd-c16f69f3255c 54868-5224 HUMAN PRESCRIPTION DRUG Tricor fenofibrate TABLET ORAL 20050216 NDA NDA021656 Physicians Total Care, Inc. FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 54868-5226_262588dd-98d4-4859-8ea6-032744c9a832 54868-5226 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20090924 ANDA ANDA078428 Physicians Total Care, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-5230_997397d5-0c64-459e-88f3-d8c289b37367 54868-5230 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20050225 ANDA ANDA040256 Physicians Total Care, Inc. PREDNISONE 10 mg/1 54868-5231_f9ed7c72-2852-43af-ad96-a591f943f92f 54868-5231 HUMAN PRESCRIPTION DRUG EMEND aprepitant CAPSULE ORAL 20050629 NDA NDA021549 Physicians Total Care, Inc. APREPITANT 80 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA] 54868-5232_80b4b640-1b66-41c8-ac0b-9cb14780db7f 54868-5232 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate LOTION TOPICAL 20071231 ANDA ANDA076493 Physicians Total Care, Inc. BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE .64; 10 mg/mL; mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5233_8552760b-6f1f-4ce3-bf29-4f3c5c11da05 54868-5233 HUMAN PRESCRIPTION DRUG Protopic Tacrolimus OINTMENT TOPICAL 20080508 NDA NDA050777 Physicians Total Care, Inc. TACROLIMUS 1 mg/g 54868-5234_906db94a-6285-451c-a3a9-4b5da597eed1 54868-5234 HUMAN PRESCRIPTION DRUG Griseofulvin griseofulvin SUSPENSION ORAL 20060116 ANDA ANDA062483 Physicians Total Care, Inc. GRISEOFULVIN 125 mg/5mL Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 54868-5236_484a0faa-15e4-4004-9d85-0d6e798da9a5 54868-5236 HUMAN PRESCRIPTION DRUG Finacea azelaic acid GEL TOPICAL 20050303 NDA NDA021470 Physicians Total Care, Inc. AZELAIC ACID .15 g/g Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE] 54868-5239_21430706-61d3-4a2b-9e2a-d6f5d33a16c1 54868-5239 HUMAN PRESCRIPTION DRUG LITHIUM CARBONATE Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20050301 ANDA ANDA076832 Physicians Total Care, Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 54868-5240_7c89711c-07e8-404e-9946-bdaefdff3df1 54868-5240 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20050303 NDA NDA020823 Physicians Total Care, Inc. RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 54868-5241_5b1397ab-09e0-41ef-b310-6967cfa4d4c4 54868-5241 HUMAN PRESCRIPTION DRUG Quinapril quinapril TABLET, FILM COATED ORAL 20050303 ANDA ANDA076607 Physicians Total Care, Inc. QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-5242_057ab8c4-3358-4eae-af12-3a57116c51a0 54868-5242 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20050303 ANDA ANDA076913 Physicians Total Care, Inc. PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5243_613f1eee-3018-45a8-a196-164c9d37a732 54868-5243 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20050307 ANDA ANDA076345 Physicians Total Care, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-5245_5b1397ab-09e0-41ef-b310-6967cfa4d4c4 54868-5245 HUMAN PRESCRIPTION DRUG Quinapril quinapril TABLET, FILM COATED ORAL 20050307 ANDA ANDA076607 Physicians Total Care, Inc. QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-5246_5b1397ab-09e0-41ef-b310-6967cfa4d4c4 54868-5246 HUMAN PRESCRIPTION DRUG Quinapril quinapril TABLET, FILM COATED ORAL 20071128 ANDA ANDA076607 Physicians Total Care, Inc. QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-5248_3d4b67bb-e159-4b4f-aa17-624515cd639f 54868-5248 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole POWDER, FOR SUSPENSION ORAL 20050311 NDA AUTHORIZED GENERIC NDA020090 Physicians Total Care, Inc. FLUCONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 54868-5249_1bbc11e0-ee07-4207-9cd9-6cba1a83be90 54868-5249 HUMAN PRESCRIPTION DRUG Avandia rosiglitazone maleate TABLET, FILM COATED ORAL 20050513 NDA NDA021071 Physicians Total Care, Inc. ROSIGLITAZONE MALEATE 2 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 54868-5250_03da19ea-d024-469b-a606-892170bb9ccd 54868-5250 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20050314 NDA NDA021687 Physicians Total Care, Inc. EZETIMIBE; SIMVASTATIN 10; 10 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5251_7376e718-265d-4d1c-9eea-d044aaf034fe 54868-5251 HUMAN PRESCRIPTION DRUG Hydrocortisone Valerate Hydrocortisone Valerate OINTMENT TOPICAL 20050315 ANDA ANDA075043 Physicians Total Care, Inc. HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5255_d975e88b-476c-463b-9600-3fbcdb0e86f2 54868-5255 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20050323 NDA NDA009218 Physicians Total Care, Inc. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54868-5256_2d55557e-ec94-4ae4-aa0b-f35df835b961 54868-5256 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20050324 ANDA ANDA076631 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5257_1e55e0e7-d2d6-40f2-8d84-66cf9768c737 54868-5257 HUMAN PRESCRIPTION DRUG MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 20050331 NDA NDA020246 Physicians Total Care, Inc. MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54868-5258_c6d171e1-6765-4e8a-833e-7b071efd94ed 54868-5258 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20050404 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 54868-5259_03da19ea-d024-469b-a606-892170bb9ccd 54868-5259 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20050404 NDA NDA021687 Physicians Total Care, Inc. EZETIMIBE; SIMVASTATIN 10; 80 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5260_16881b74-dac8-403b-8a75-b1ca2732ab11 54868-5260 HUMAN PRESCRIPTION DRUG Xeloda capecitabine TABLET, FILM COATED ORAL 20050628 NDA NDA020896 Physicians Total Care, Inc. CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 54868-5261_5680d1f0-5242-42a9-a64e-2cd387a6ee96 54868-5261 HUMAN PRESCRIPTION DRUG Aromasin exemestane TABLET ORAL 20050629 NDA NDA020753 Physicians Total Care, Inc. EXEMESTANE 25 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 54868-5266_447e39ea-78d1-47f1-80f0-a95bdc4ed962 54868-5266 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20050415 NDA NDA021035 Physicians Total Care, Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-5268_a19e649e-2636-4708-b3f0-3d2ebcbffb2d 54868-5268 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20050418 ANDA ANDA076301 Physicians Total Care, Inc. LORATADINE 10 mg/1 54868-5269_63f46afc-ac6d-4391-bcd0-7b17fc6e8dea 54868-5269 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20050420 ANDA ANDA065134 Physicians Total Care, Inc. DOXYCYCLINE HYCLATE 20 mg/1 54868-5270_3503c781-8fbd-424c-a9f4-17212e8a723b 54868-5270 HUMAN PRESCRIPTION DRUG Ciclopirox Olamine ciclopirox olamine CREAM TOPICAL 20050401 ANDA ANDA076790 Physicians Total Care, Inc. CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 54868-5271_d972a09a-e421-403c-b9bf-9cbd738fa99c 54868-5271 HUMAN PRESCRIPTION DRUG Differin adapalene CREAM TOPICAL 20050419 NDA NDA020748 Physicians Total Care, Inc. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-5273_9bd52b97-5d46-4329-849f-7a49ebdbb8c7 54868-5273 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050427 NDA NDA021476 Physicians Total Care, Inc. ESZOPICLONE 2 mg/1 CIV 54868-5274_14d86267-3396-4311-9f0b-64fe41fbb8cb 54868-5274 HUMAN PRESCRIPTION DRUG Etodolac etodolac CAPSULE ORAL 20050427 ANDA ANDA075078 Physicians Total Care, Inc. ETODOLAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-5275_dadf8ed3-b155-4449-a74e-1ebdf9b10a06 54868-5275 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20100114 ANDA ANDA077031 Physicians Total Care, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-5279_5b1397ab-09e0-41ef-b310-6967cfa4d4c4 54868-5279 HUMAN PRESCRIPTION DRUG Quinapril quinapril TABLET, FILM COATED ORAL 20050722 ANDA ANDA076607 Physicians Total Care, Inc. QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-5281_5e8eb86c-a083-49e9-9562-e45d3e5c7f13 54868-5281 HUMAN PRESCRIPTION DRUG Teveten HCT Eprosartan Mesylate and Hydrochlorothiazide TABLET ORAL 20050506 NDA NDA021268 Physicians Total Care, Inc. EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE 600; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5282_34d636a5-b7c9-41dc-83be-85caf213096f 54868-5282 HUMAN PRESCRIPTION DRUG mercaptopurine mercaptopurine TABLET ORAL 20050523 ANDA ANDA040461 Physicians Total Care, Inc. MERCAPTOPURINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 54868-5286_fb1f04a2-345a-44cd-ac48-a0cc5bc70a06 54868-5286 HUMAN PRESCRIPTION DRUG Nortrel 7/7/7 (28 Day Regimen) Norethindrone and Ethinyl Estradiol KIT 20080819 ANDA ANDA075478 Physicians Total Care, Inc. 54868-5287_ef488235-15c6-4466-8540-5f30e365ab68 54868-5287 HUMAN OTC DRUG Calmoseptine Zinc Oxide and menthol OINTMENT TOPICAL 20060719 OTC MONOGRAPH FINAL part347 Physicians Total Care, Inc. MENTHOL; ZINC OXIDE .44; 20.6 g/113g; g/113g 54868-5290_fb809355-146a-4baf-a029-a80b7faee7bb 54868-5290 HUMAN PRESCRIPTION DRUG Tarceva erlotinib hydrochloride TABLET ORAL 20050701 NDA NDA021743 Physicians Total Care, Inc. ERLOTINIB HYDROCHLORIDE 25 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 54868-5291_176d3ea3-8f7f-4827-a347-9676bf861d68 54868-5291 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen tramadol hydrochloride and acetaminophen TABLET ORAL 20050512 ANDA ANDA076475 Physicians Total Care, Inc. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 54868-5292_5fb1d869-76bb-4298-acf8-d318208d91e5 54868-5292 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate SOLUTION TOPICAL 20050512 ANDA ANDA074222 Physicians Total Care, Inc. CLOBETASOL PROPIONATE .462 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5295_8b910c5e-691b-492d-95df-bb01fd6b0c4f 54868-5295 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 20050516 ANDA ANDA074172 Physicians Total Care, Inc. NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-5296_2d55557e-ec94-4ae4-aa0b-f35df835b961 54868-5296 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20050516 ANDA ANDA076631 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5297_e8331ace-719a-4405-97f1-fb137e7c2444 54868-5297 HUMAN PRESCRIPTION DRUG Micardis HCT TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET ORAL 20050630 NDA NDA021162 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 25; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5299_e1216318-f183-4a90-8265-8bb6a58cc5d2 54868-5299 HUMAN PRESCRIPTION DRUG SUCRALFATE Sucralfate SUSPENSION ORAL 20050524 NDA NDA019183 Physicians Total Care, Inc. SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 54868-5303_183fd856-868e-459a-8361-66ca5ac363e3 54868-5303 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20050517 NDA NDA021428 Physicians Total Care, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 54868-5307_580d387f-c4ba-4a04-b664-8b93aa6fe483 54868-5307 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate Clindamycin Phosphate CREAM VAGINAL 20050519 ANDA ANDA065139 Physicians Total Care, Inc. CLINDAMYCIN PHOSPHATE 20 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 54868-5308_c493f7e4-0466-4ae6-acf9-26734af024bc 54868-5308 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20050523 ANDA ANDA079096 Physicians Total Care, Inc. NAPROXEN SODIUM 220 mg/1 54868-5309_3ab3af08-bbd8-4fe4-ba32-971374fe2b30 54868-5309 HUMAN OTC DRUG Prilosec OTC omeprazole magnesium TABLET, DELAYED RELEASE ORAL 20050523 NDA NDA021229 Physicians Total Care, Inc. OMEPRAZOLE MAGNESIUM 20.6 mg/1 54868-5310_7621a198-f26d-4f41-bba6-5d9d2088a7c1 54868-5310 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20050523 ANDA ANDA077621 Physicians Total Care, Inc. AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 54868-5311_3f280d6c-7cf4-47c4-8b1f-3a6218a7cf84 54868-5311 HUMAN PRESCRIPTION DRUG Tarka Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050527 NDA NDA020591 Physicians Total Care, Inc. TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-5312_dba74198-1341-41e1-9f6e-a756104c434b 54868-5312 HUMAN PRESCRIPTION DRUG Levothroid LEVOTHYROXINE SODIUM TABLET ORAL 20050520 NDA NDA021116 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-5313_78f83075-c908-4385-8690-9ff0a573ff17 54868-5313 HUMAN PRESCRIPTION DRUG Lotensin HCT benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20050523 NDA NDA020033 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5315_334e3947-0fd2-49b0-ba27-cc2a8ab32e47 54868-5315 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20081121 NDA NDA021427 Physicians Total Care, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-5320_3f280d6c-7cf4-47c4-8b1f-3a6218a7cf84 54868-5320 HUMAN PRESCRIPTION DRUG Tarka Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090625 NDA NDA020591 Physicians Total Care, Inc. TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 4; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-5322_6a4ba197-e3bc-4e54-9a33-bc48bb880d49 54868-5322 HUMAN PRESCRIPTION DRUG Boniva ibandronate sodium TABLET, FILM COATED ORAL 20050602 NDA NDA021455 Physicians Total Care, Inc. IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 54868-5323_745ce298-abcb-4d11-8c0e-79776cdc6e2e 54868-5323 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20081125 NDA NDA020818 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5325_f9ed7c72-2852-43af-ad96-a591f943f92f 54868-5325 HUMAN PRESCRIPTION DRUG Emend aprepitant KIT 20050624 NDA NDA021549 Physicians Total Care, Inc. 54868-5326_01fd5716-bb59-49b0-a0ed-8da299cf060f 54868-5326 HUMAN PRESCRIPTION DRUG Junel Fe 1/20 norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20050603 ANDA ANDA076081 Physicians Total Care, Inc. 54868-5327_ca8c3e5e-b0aa-498e-becd-02cdb41714df 54868-5327 HUMAN PRESCRIPTION DRUG NovoLog Mix 70/30 insulin aspart INJECTION, SUSPENSION SUBCUTANEOUS 20110517 NDA NDA021172 Physicians Total Care, Inc. INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 54868-5334_cee4126c-21b9-4f7c-b85f-cd2838d19d3e 54868-5334 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20050613 ANDA ANDA040700 Physicians Total Care, Inc. DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5336_ab9d67ba-3e66-4664-a376-b65a4bfa7331 54868-5336 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20050614 NDA NDA020592 Physicians Total Care, Inc. OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 54868-5337_74ba7709-016b-437d-be8e-2dc3c28d724e 54868-5337 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate CREAM TOPICAL 20060913 ANDA ANDA076793 Physicians Total Care, Inc. FLUTICASONE PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5338_a1a2b20f-2261-4d4f-8bd8-bac39ed027bf 54868-5338 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20081014 ANDA ANDA040545 Physicians Total Care, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-5339_7c89711c-07e8-404e-9946-bdaefdff3df1 54868-5339 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20050617 NDA NDA020823 Physicians Total Care, Inc. RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 54868-5340_e481894d-6e16-4823-8399-91fccce085af 54868-5340 HUMAN PRESCRIPTION DRUG LITHIUM CARBONATE Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20050622 ANDA ANDA076490 Physicians Total Care, Inc. LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] 54868-5341_ec82c251-eebc-4210-9920-6cd5a827a177 54868-5341 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20050622 NDA NDA021366 Physicians Total Care, Inc. ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5343_1464cdb0-3223-4e7b-81fb-c9f1b4a57f0f 54868-5343 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 20050705 NDA NDA020505 Physicians Total Care, Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-5345_3d4b67bb-e159-4b4f-aa17-624515cd639f 54868-5345 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 20050706 NDA AUTHORIZED GENERIC NDA019949 Physicians Total Care, Inc. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 54868-5346_618032df-c98a-47c7-a522-a42f5bd3e1d2 54868-5346 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20050706 ANDA ANDA090228 Physicians Total Care, Inc. FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5347_52f498a2-11b0-46be-bb67-14054aa3c2c5 54868-5347 HUMAN PRESCRIPTION DRUG PAXILCR CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050706 NDA NDA020936 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-5348_cef15d8b-d8c6-491e-9549-695ddc33892b 54868-5348 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 20051020 NDA NDA021029 Physicians Total Care, Inc. TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 54868-5350_cef15d8b-d8c6-491e-9549-695ddc33892b 54868-5350 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 20051007 NDA NDA021029 Physicians Total Care, Inc. TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 54868-5351_7afd87aa-acc7-459e-8c50-a6e663a3455e 54868-5351 HUMAN PRESCRIPTION DRUG Derma-Smoothe/FS fluocinolone acetonide OIL TOPICAL 20090903 NDA NDA019452 Physicians Total Care, Inc. FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5354_cef15d8b-d8c6-491e-9549-695ddc33892b 54868-5354 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 20060413 NDA NDA021029 Physicians Total Care, Inc. TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 54868-5356_962db524-45ec-4e36-8aab-8ed2e5a697fc 54868-5356 HUMAN PRESCRIPTION DRUG AVIANE levonorgestrel and ethinyl estradiol KIT 20050708 ANDA ANDA075796 Physicians Total Care, Inc. 54868-5362_e545053a-9ad5-48f1-94c5-8ae86735e581 54868-5362 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20050713 NDA NDA021433 Physicians Total Care, Inc. FLUTICASONE PROPIONATE 110 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5363_931dca5a-f555-459e-8f09-ae71f80b8960 54868-5363 HUMAN PRESCRIPTION DRUG Enablex darifenacin TABLET, EXTENDED RELEASE ORAL 20050720 NDA NDA021513 Physicians Total Care, Inc. DARIFENACIN 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54868-5364_845f8e7d-6ebc-4986-8cec-a4b58a0d1a69 54868-5364 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050725 ANDA ANDA076467 Physicians Total Care, Inc. GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-5365_52f498a2-11b0-46be-bb67-14054aa3c2c5 54868-5365 HUMAN PRESCRIPTION DRUG PAXILCR CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050721 NDA NDA020936 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE 37.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-5368_bdecce86-e035-472d-8131-180414c321fe 54868-5368 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20020726 NDA NDA021303 Physicians Total Care, Inc. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-5376_775e2b02-fe2c-4563-a982-c57f34996cc7 54868-5376 HUMAN PRESCRIPTION DRUG AVANDAMET rosiglitazone maleate and metformin hydrochloride TABLET, FILM COATED ORAL 20050803 NDA NDA021410 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 1000; 2 mg/1; mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-5377_e4fe38fa-19f0-4476-9723-e51767dfeb78 54868-5377 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20070410 ANDA ANDA075932 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 54868-5381_b0b40e1a-682f-4d7e-813a-b4857a1da71f 54868-5381 HUMAN PRESCRIPTION DRUG Prandin repaglinide TABLET ORAL 20050808 NDA NDA020741 Physicians Total Care, Inc. REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 54868-5384_e0cceca4-759d-4ca9-be65-23a0199e5766 54868-5384 HUMAN PRESCRIPTION DRUG BYETTA exenatide INJECTION SUBCUTANEOUS 20050809 NDA NDA021773 Physicians Total Care, Inc. EXENATIDE 250 ug/mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] 54868-5387_e1ec8388-3aeb-4259-8201-486191f06c84 54868-5387 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20050811 ANDA ANDA040440 Physicians Total Care, Inc. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-5388_9fc8399c-25aa-492f-bc7b-596cbae4d39c 54868-5388 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20050815 ANDA ANDA076137 Physicians Total Care, Inc. DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-5389_39263f83-7ec6-4fa7-a861-1e9897ab7c48 54868-5389 HUMAN PRESCRIPTION DRUG MEGESTROL ACETATE megestrol acetate SUSPENSION ORAL 20050901 ANDA ANDA075671 Physicians Total Care, Inc. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54868-5390_3b9af72f-c970-4248-b050-fc675fbd5825 54868-5390 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET ORAL 20081001 ANDA ANDA077712 Physicians Total Care, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-5391_d43f9c40-5039-42e9-871d-286bbb26cc68 54868-5391 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20071030 ANDA ANDA076369 Physicians Total Care, Inc. PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] 54868-5392_4bea215c-7140-4209-bc87-04f71058d569 54868-5392 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20050819 ANDA ANDA076211 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-5394_9bd52b97-5d46-4329-849f-7a49ebdbb8c7 54868-5394 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050824 NDA NDA021476 Physicians Total Care, Inc. ESZOPICLONE 3 mg/1 CIV 54868-5397_79201e83-d9e6-42a7-98b6-bd51edbdc233 54868-5397 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050826 NDA NDA021259 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-5398_b5a4afc1-5622-4146-b1af-66f54f922425 54868-5398 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20050829 NDA NDA021518 Physicians Total Care, Inc. SOLIFENACIN SUCCINATE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54868-5400_ba80da42-fe66-4664-b91b-3ad6f83ad3b2 54868-5400 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE metoprolol tartrate and hydrochlorothiazide TABLET ORAL 20050901 ANDA ANDA076792 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25; 50 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5401_fbfd8785-c77f-438a-9f62-251362dc80a7 54868-5401 HUMAN PRESCRIPTION DRUG Klaron sulfacetamide sodium LOTION TOPICAL 20050901 NDA NDA019931 Physicians Total Care, Inc. SULFACETAMIDE SODIUM 10 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 54868-5405_87b9641a-07be-4e3d-84a8-a9f2b8c19a77 54868-5405 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20050902 ANDA ANDA076278 Physicians Total Care, Inc. FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] 54868-5409_de4c4a2a-bfa3-4149-a524-e90623c34ce1 54868-5409 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20070404 ANDA ANDA020872 Physicians Total Care, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 54868-5411_22f68cbf-a96c-442a-a124-082f276cd6c3 54868-5411 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20050909 ANDA ANDA077022 Physicians Total Care, Inc. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 54868-5412_898c5e2b-1c01-486f-a82e-0345fd3c5575 54868-5412 HUMAN PRESCRIPTION DRUG MIRAPEX pramipexole dihydrochloride TABLET ORAL 20050912 NDA NDA020667 Physicians Total Care, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 54868-5413_5cb043a9-862b-4ba3-8ee3-03f9aa660dee 54868-5413 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE morphine sulfate SOLUTION ORAL 20050912 NDA NDA022195 Physicians Total Care, Inc. MORPHINE SULFATE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-5415_f0646bea-d356-441c-8b53-a89245a3762c 54868-5415 HUMAN PRESCRIPTION DRUG Cenestin synthetic conjugated estrogens, A TABLET, FILM COATED ORAL 20050913 NDA NDA020992 Physicians Total Care, Inc. ESTROGENS, CONJUGATED SYNTHETIC A .45 mg/1 54868-5416_4062960e-f215-4ffd-a79e-241c34a67746 54868-5416 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 20070928 NDA NDA020564 Physicians Total Care, Inc. LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 54868-5417_de4c4a2a-bfa3-4149-a524-e90623c34ce1 54868-5417 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20060807 ANDA ANDA020872 Physicians Total Care, Inc. FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 54868-5418_e8331ace-719a-4405-97f1-fb137e7c2444 54868-5418 HUMAN PRESCRIPTION DRUG Micardis HCT TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET ORAL 20050920 NDA NDA021162 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5419_b9fe23f0-ce84-42d7-99a8-3a246ead86d5 54868-5419 HUMAN PRESCRIPTION DRUG Allegra--D 24 Hour fexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050914 NDA NDA021704 Physicians Total Care, Inc. FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180; 240 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] CV 54868-5420_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-5420 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20050914 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5421_c5337d48-36f3-47ec-bd06-f7f7c8b65c0c 54868-5421 HUMAN PRESCRIPTION DRUG OLUX clobetasol propionate AEROSOL, FOAM TOPICAL 20050915 NDA NDA021142 Physicians Total Care, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5424_7a3f76ec-3c2f-4a29-92a0-68cd8e1ce066 54868-5424 HUMAN PRESCRIPTION DRUG LUXIQ betamethasone valerate AEROSOL, FOAM TOPICAL 20050921 NDA NDA020934 Physicians Total Care, Inc. BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5426_88b5ba9c-16df-404f-8453-a38940e2b710 54868-5426 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20091124 NDA NDA021774 Physicians Total Care, Inc. ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 54868-5430_9cd64ccb-3e5a-43b1-a080-3abc86f9b4e8 54868-5430 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20051005 ANDA ANDA065136 Physicians Total Care, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 54868-5432_001a1b71-7868-44a2-9e28-6935cb4a9718 54868-5432 HUMAN PRESCRIPTION DRUG Carbatrol carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20091015 NDA NDA020712 Physicians Total Care, Inc. CARBAMAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 54868-5434_7052259b-d0e1-4b0e-8af6-28dfcb16c893 54868-5434 HUMAN PRESCRIPTION DRUG Mefloquine Hydrochloride mefloquine hydrochloride TABLET ORAL 20050926 ANDA ANDA076175 Physicians Total Care, Inc. MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC] 54868-5435_190ac700-81ee-4cba-b80c-a686bae27178 54868-5435 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20060101 ANDA ANDA076577 Physicians Total Care, Inc. MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 54868-5436_f1dcf381-23f1-4eb4-897b-dede1cae786f 54868-5436 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride TABLET, FILM COATED ORAL 20110721 ANDA ANDA077220 Physicians Total Care, Inc. PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 54868-5437_09dfcc1a-9623-4473-8471-0865f3a46f86 54868-5437 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 20081015 ANDA ANDA075219 Physicians Total Care, Inc. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-5438_65da42c7-85b3-4973-8dbe-99a26de7b227 54868-5438 HUMAN PRESCRIPTION DRUG Mephyton phytonadione TABLET ORAL 20060321 NDA NDA010104 Physicians Total Care, Inc. PHYTONADIONE 5 mg/1 Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 54868-5439_9bd52b97-5d46-4329-849f-7a49ebdbb8c7 54868-5439 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20060929 NDA NDA021476 Physicians Total Care, Inc. ESZOPICLONE 1 mg/1 CIV 54868-5440_cf63553d-cb67-44c0-8c5f-44683f9a30ac 54868-5440 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20051006 NDA NDA020164 Physicians Total Care, Inc. ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 54868-5442_ca6a9e8a-2cba-4775-8131-cb8d8db28ea8 54868-5442 HUMAN PRESCRIPTION DRUG ProAmatine midodrine hydrochloride TABLET ORAL 20050930 NDA NDA019815 Physicians Total Care, Inc. MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 54868-5443_e34908ed-0298-4597-812e-7108d8a56d98 54868-5443 HUMAN PRESCRIPTION DRUG Anagrelide Hydrochloride Anagrelide Hydrochloride CAPSULE ORAL 20070719 ANDA ANDA076468 Physicians Total Care, Inc. ANAGRELIDE HYDROCHLORIDE .5 mg/1 Decreased Platelet Production [PE],Platelet-reducing Agent [EPC],Phosphodiesterase 3 Inhibitors [MoA] 54868-5446_fd513374-c466-41fa-bd54-7017a52cd95a 54868-5446 HUMAN PRESCRIPTION DRUG Fludrocortisone Acetate fludrocortisone acetate TABLET ORAL 20051006 ANDA ANDA040431 Physicians Total Care, Inc. FLUDROCORTISONE ACETATE .1 mg/1 54868-5447_fb809355-146a-4baf-a029-a80b7faee7bb 54868-5447 HUMAN PRESCRIPTION DRUG Tarceva erlotinib hydrochloride TABLET ORAL 20051013 NDA NDA021743 Physicians Total Care, Inc. ERLOTINIB HYDROCHLORIDE 150 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 54868-5448_9c8577a5-8492-49be-b6d9-c657beb86a90 54868-5448 HUMAN PRESCRIPTION DRUG MIRTAZAPINE Mirtazapine TABLET ORAL 20051007 ANDA ANDA076122 Physicians Total Care, Inc. MIRTAZAPINE 30 mg/1 54868-5455_85023684-7a16-4f9c-8fca-fe08e0618814 54868-5455 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20060330 ANDA ANDA078541 Physicians Total Care, Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5456_cc07c7d6-d6d4-473a-8e5f-e64d1f1ae362 54868-5456 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20051019 NDA NDA021446 Physicians Total Care, Inc. PREGABALIN 150 mg/1 CV 54868-5457_b2688fe1-f2f1-4c67-8420-0647a0ff0694 54868-5457 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051020 ANDA ANDA076802 Physicians Total Care, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-5458_986b35e3-4bc7-47af-923e-a7e1f34fac01 54868-5458 HUMAN PRESCRIPTION DRUG Fluticasone Propionate fluticasone propionate OINTMENT TOPICAL 20051020 ANDA ANDA076668 Physicians Total Care, Inc. FLUTICASONE PROPIONATE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5459_e028add7-0ff7-409f-8e66-cb9e8986d403 54868-5459 HUMAN PRESCRIPTION DRUG Xopenex levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20051020 NDA NDA020837 Physicians Total Care, Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 54868-5461_88b5ba9c-16df-404f-8453-a38940e2b710 54868-5461 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20051007 NDA NDA021774 Physicians Total Care, Inc. ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 54868-5463_abf93477-f551-4e30-ba94-b2981a9d90cd 54868-5463 HUMAN PRESCRIPTION DRUG Clotrimazole clotrimazole LOZENGE ORAL 20090723 ANDA ANDA076763 Physicians Total Care, Inc. CLOTRIMAZOLE 10 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 54868-5464_853a6948-6069-4b70-993c-b7ce40b9eafd 54868-5464 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE PELLETS ORAL 20071213 ANDA ANDA077167 Physicians Total Care, Inc. DIDANOSINE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 54868-5465_4fe6e815-1d03-40df-ad3d-4d12de9648dc 54868-5465 HUMAN PRESCRIPTION DRUG Avalide irbesartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20051101 NDA NDA020758 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; IRBESARTAN 25; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5467_723ef500-4b12-4d0d-b926-ae59e21fe0e0 54868-5467 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051114 ANDA ANDA077270 Physicians Total Care, Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-5468_de4c4a2a-bfa3-4149-a524-e90623c34ce1 54868-5468 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20051109 ANDA ANDA020872 Physicians Total Care, Inc. FEXOFENADINE HYDROCHLORIDE 30 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 54868-5469_618032df-c98a-47c7-a522-a42f5bd3e1d2 54868-5469 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20051115 ANDA ANDA090228 Physicians Total Care, Inc. FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5471_db900408-b413-4795-9749-e75a8a53d1c5 54868-5471 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065211 Physicians Total Care, Inc. AZITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54868-5472_03e2ff00-c8ab-43dc-94af-4705dde13a8c 54868-5472 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20080420 ANDA ANDA065390 Physicians Total Care, Inc. RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 54868-5474_fb809355-146a-4baf-a029-a80b7faee7bb 54868-5474 HUMAN PRESCRIPTION DRUG Tarceva erlotinib hydrochloride TABLET ORAL 20051121 NDA NDA021743 Physicians Total Care, Inc. ERLOTINIB HYDROCHLORIDE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 54868-5475_8e359d73-d777-49d9-af50-724344f1a879 54868-5475 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20080101 ANDA ANDA078211 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5477_54642793-18db-4fca-9056-a2ca5a740e59 54868-5477 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20051121 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-5478_db900408-b413-4795-9749-e75a8a53d1c5 54868-5478 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051123 ANDA ANDA065211 Physicians Total Care, Inc. AZITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54868-5479_9fc8399c-25aa-492f-bc7b-596cbae4d39c 54868-5479 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20051130 ANDA ANDA076137 Physicians Total Care, Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-5480_758dea45-6f23-49fd-80a0-d4cc884202df 54868-5480 HUMAN PRESCRIPTION DRUG FOSAMAX PLUS D alendronate sodium and cholecalciferol TABLET ORAL 20051130 NDA NDA021762 Physicians Total Care, Inc. ALENDRONATE SODIUM; CHOLECALCIFEROL 70; 2800 mg/1; [iU]/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 54868-5482_98ac152f-ad1c-4f80-b3a3-b122c3702057 54868-5482 HUMAN PRESCRIPTION DRUG Halobetasol Propionate halobetasol propionate OINTMENT TOPICAL 20051205 ANDA ANDA076872 Physicians Total Care, Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5484_a8e03fcb-e9fd-40e2-8516-febf36072b05 54868-5484 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20111118 NDA NDA020639 Physicians Total Care, Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 54868-5487_db900408-b413-4795-9749-e75a8a53d1c5 54868-5487 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20070810 ANDA ANDA065212 Physicians Total Care, Inc. AZITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54868-5494_cc07c7d6-d6d4-473a-8e5f-e64d1f1ae362 54868-5494 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20051220 NDA NDA021446 Physicians Total Care, Inc. PREGABALIN 50 mg/1 CV 54868-5499_5855b6df-3949-4d36-b210-0fa2e5db974d 54868-5499 HUMAN PRESCRIPTION DRUG Fortical calcitonin salmon SPRAY, METERED NASAL 20051230 NDA NDA021406 Physicians Total Care, Inc. CALCITONIN SALMON 2200 [iU]/mL Calcitonin [Chemical/Ingredient],Calcitonin [EPC] 54868-5500_76dbc4d8-b42f-49ec-b0b6-d19b74ffb051 54868-5500 HUMAN PRESCRIPTION DRUG Actoplus Met pioglitazone hydrochloride and metformin hydrochloride TABLET, FILM COATED ORAL 20060104 NDA NDA021842 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-5501_b9d65d39-a065-4ce1-8c67-df4139d291bf 54868-5501 HUMAN PRESCRIPTION DRUG ARIXTRA fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20041117 NDA NDA021345 Physicians Total Care, Inc. FONDAPARINUX SODIUM 7.5 mg/.6mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 54868-5503_13b193d2-e076-491d-b20c-c5c8d7d8a47c 54868-5503 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060110 ANDA ANDA076486 Physicians Total Care, Inc. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 5; 12.5 g/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5505_820acf57-1076-4cf1-ab84-1b3fe2cf5b53 54868-5505 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20060117 ANDA ANDA077336 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-5506_69f41cbb-bce2-48d9-bd95-1566adabf870 54868-5506 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 20060120 NDA NDA020998 Physicians Total Care, Inc. CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-5510_fbf1ab44-6114-49ef-9223-4fd6bcf832eb 54868-5510 HUMAN PRESCRIPTION DRUG Clobex clobetasol propionate SPRAY TOPICAL 20060123 NDA NDA021835 Physicians Total Care, Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5511_e088942f-17c9-4598-8153-0366f361bfd1 54868-5511 HUMAN PRESCRIPTION DRUG AtroventHFA ipratropium bromide AEROSOL, METERED RESPIRATORY (INHALATION) 20060120 NDA NDA021527 Physicians Total Care, Inc. IPRATROPIUM BROMIDE 17 ug/1 54868-5522_db323395-0dbc-47bd-bc21-85b754faa472 54868-5522 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED ORAL 20060210 ANDA ANDA065040 Physicians Total Care, Inc. CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 54868-5523_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-5523 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20090415 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5524_ba80da42-fe66-4664-b91b-3ad6f83ad3b2 54868-5524 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE metoprolol tartrate and hydrochlorothiazide TABLET ORAL 20060207 ANDA ANDA076792 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25; 100 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5525_79aec30f-078c-407a-b179-fa5d3e9098d2 54868-5525 HUMAN PRESCRIPTION DRUG Depakote divalproex sodium TABLET, EXTENDED RELEASE ORAL 20060210 NDA NDA021168 Physicians Total Care, Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 54868-5526_154afefc-0884-4dd2-98f4-a7f8f4d7e203 54868-5526 HUMAN PRESCRIPTION DRUG Cholestyramine cholestyramine POWDER, FOR SUSPENSION ORAL 20060208 ANDA ANDA077203 Physicians Total Care, Inc. CHOLESTYRAMINE 4 g/5g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 54868-5527_496c5df0-d2c8-4bd8-8eb3-7293863db328 54868-5527 HUMAN PRESCRIPTION DRUG Axert almotriptan malate TABLET, COATED ORAL 20060209 NDA NDA021001 Physicians Total Care, Inc. ALMOTRIPTAN MALATE 12.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 54868-5528_b983e8ee-810a-4435-b63f-64512ca2e540 54868-5528 HUMAN PRESCRIPTION DRUG Relpax eletriptan hydrobromide TABLET, FILM COATED ORAL 20071119 NDA NDA021016 Physicians Total Care, Inc. ELETRIPTAN HYDROBROMIDE 40 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 54868-5533_2fad5b6f-85fa-4c52-a08e-6812b98294f0 54868-5533 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080115 ANDA ANDA065230 Physicians Total Care, Inc. CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54868-5534_c4b582ba-6407-47f8-a96a-eeb47c7f4d12 54868-5534 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20070712 ANDA ANDA040684 Physicians Total Care, Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-5538_7f1345f7-1271-4312-b33e-9ba15b3d6f77 54868-5538 HUMAN PRESCRIPTION DRUG Estring estradiol RING VAGINAL 20060227 NDA NDA020472 Physicians Total Care, Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-5545_ab08844e-a200-402a-9414-65d592a23eeb 54868-5545 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20060308 ANDA ANDA076504 Physicians Total Care, Inc. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5547_19adf6fb-8fe1-432e-943f-72fa9524cc20 54868-5547 HUMAN PRESCRIPTION DRUG Asmanex Mometasone Furoate INHALANT RESPIRATORY (INHALATION) 20060309 NDA NDA021067 Physicians Total Care, Inc. MOMETASONE FUROATE 220 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5548_3f280d6c-7cf4-47c4-8b1f-3a6218a7cf84 54868-5548 HUMAN PRESCRIPTION DRUG Tarka Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090101 NDA NDA020591 Physicians Total Care, Inc. TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2; 180 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-5549_fc7059c3-f7ca-44e6-97d3-032fa8154037 54868-5549 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20060314 ANDA ANDA075366 Physicians Total Care, Inc. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC] 54868-5550_cc07c7d6-d6d4-473a-8e5f-e64d1f1ae362 54868-5550 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20061101 NDA NDA021446 Physicians Total Care, Inc. PREGABALIN 75 mg/1 CV 54868-5551_967fdce1-748b-4ebf-a954-285fd1e629b5 54868-5551 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20060316 ANDA ANDA076404 Physicians Total Care, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 54868-5553_76dbc4d8-b42f-49ec-b0b6-d19b74ffb051 54868-5553 HUMAN PRESCRIPTION DRUG Actoplus Met pioglitazone hydrochloride and metformin hydrochloride TABLET, FILM COATED ORAL 20060321 NDA NDA021842 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-5558_e150632a-d379-4a7a-9fd9-b4cb34fa3179 54868-5558 HUMAN PRESCRIPTION DRUG Fortamet metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20060324 NDA NDA021574 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 54868-5564_94674abb-9b63-4684-8e32-567c07e13cbb 54868-5564 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20060330 ANDA ANDA078955 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-5565_872a2746-4e6f-4773-bdbf-ad94f2bc4563 54868-5565 HUMAN PRESCRIPTION DRUG Atrovent ipratropium bromide SPRAY, METERED NASAL 20060331 NDA NDA020393 Physicians Total Care, Inc. IPRATROPIUM BROMIDE 21 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 54868-5566_7be35561-8a33-4a3e-a126-c1dd7239fbd4 54868-5566 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20060411 NDA NDA021906 Physicians Total Care, Inc. LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] 54868-5567_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-5567 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20091130 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5570_f1ca50f6-37f5-4e14-a2ea-4d1daaf67ec4 54868-5570 HUMAN PRESCRIPTION DRUG Climara Pro Estradiol and Levonorgestrel PATCH TRANSDERMAL 20060413 NDA NDA021258 Physicians Total Care, Inc. ESTRADIOL; LEVONORGESTREL 4.4; 1.39 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 54868-5572_35ce8e47-1109-411e-86a0-e9efe0eb589e 54868-5572 HUMAN PRESCRIPTION DRUG MEGACE ES megesterol acetate SUSPENSION ORAL 20060413 NDA NDA021778 Physicians Total Care, Inc. MEGESTROL ACETATE 125 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54868-5574_a3258584-041c-4671-b77c-096eefb3e421 54868-5574 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 20060419 ANDA ANDA074918 Physicians Total Care, Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] 54868-5575_df3a79de-c4f4-485e-bb53-082e9ccb818d 54868-5575 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20060601 ANDA ANDA075868 Physicians Total Care, Inc. FENOFIBRATE 200 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 54868-5576_28a99cae-b12b-4528-b922-bfee7c5e2dfa 54868-5576 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20070125 ANDA ANDA076056 Physicians Total Care, Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5577_28a99cae-b12b-4528-b922-bfee7c5e2dfa 54868-5577 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20060511 ANDA ANDA076056 Physicians Total Care, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5578_28a99cae-b12b-4528-b922-bfee7c5e2dfa 54868-5578 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20060511 ANDA ANDA076056 Physicians Total Care, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5579_28a99cae-b12b-4528-b922-bfee7c5e2dfa 54868-5579 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20091211 ANDA ANDA077793 Physicians Total Care, Inc. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5580_700666ac-e66f-46d6-bb1d-62d4dcea8e75 54868-5580 HUMAN OTC DRUG LORATADINE Loratadine SOLUTION ORAL 20060428 ANDA ANDA076805 Physicians Total Care, Inc. LORATADINE 5 mg/5mL 54868-5581_a8e03fcb-e9fd-40e2-8516-febf36072b05 54868-5581 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20060428 NDA NDA020639 Physicians Total Care, Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 54868-5585_a18a9839-6241-43cd-a50b-22266e7a9589 54868-5585 HUMAN PRESCRIPTION DRUG METROGEL metronidazole GEL TOPICAL 20060728 NDA NDA021789 Physicians Total Care, Inc. METRONIDAZOLE 10 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 54868-5586_87b9641a-07be-4e3d-84a8-a9f2b8c19a77 54868-5586 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20080930 ANDA ANDA076278 Physicians Total Care, Inc. FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] 54868-5587_cf63553d-cb67-44c0-8c5f-44683f9a30ac 54868-5587 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20060517 NDA NDA020164 Physicians Total Care, Inc. ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 54868-5589_2fad5b6f-85fa-4c52-a08e-6812b98294f0 54868-5589 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060512 ANDA ANDA065230 Physicians Total Care, Inc. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54868-5590_c50edaa2-4f73-4ed5-a237-752242c00736 54868-5590 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, EXTENDED RELEASE ORAL 20060517 ANDA ANDA075295 Physicians Total Care, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-5597_b34b187e-d110-48df-9687-c255eec7910f 54868-5597 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20060501 ANDA ANDA071611 Physicians Total Care, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 54868-5600_458d20ef-7350-4cee-8a64-d59d9d8b1084 54868-5600 HUMAN PRESCRIPTION DRUG EPZICOM abacavir sulfate and lamivudine TABLET, FILM COATED ORAL 20060522 NDA NDA021652 Physicians Total Care, Inc. ABACAVIR SULFATE; LAMIVUDINE 600; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 54868-5602_983a15fb-e0d8-4e75-aa92-ade42e5e625a 54868-5602 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate SOLUTION NASAL 20060522 ANDA ANDA074830 Physicians Total Care, Inc. DESMOPRESSIN ACETATE .1 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 54868-5604_2a0dd457-4727-47ff-9268-e9e1b9d17b30 54868-5604 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 20060621 NDA NDA020475 Physicians Total Care, Inc. TRETINOIN .4 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-5607_745ce298-abcb-4d11-8c0e-79776cdc6e2e 54868-5607 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20081204 NDA NDA020818 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5611_4d0d7e92-f5a0-4018-9dbd-add04c9fb609 54868-5611 HUMAN PRESCRIPTION DRUG Zegerid omeprazole, sodium bicarbonate CAPSULE ORAL 20060608 NDA NDA021849 Physicians Total Care, Inc. OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 54868-5614_fc7059c3-f7ca-44e6-97d3-032fa8154037 54868-5614 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20090408 ANDA ANDA075366 Physicians Total Care, Inc. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC] 54868-5616_da3f3b40-907e-4111-a726-366b8dcfc997 54868-5616 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20100302 NDA NDA021688 Physicians Total Care, Inc. CINACALCET HYDROCHLORIDE 30 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] 54868-5617_031259f7-58e2-4bb8-bcc1-a582bde4ee9a 54868-5617 HUMAN PRESCRIPTION DRUG Erythromycin-Benzoyl Peroxide Erythromycin-Benzoyl Peroxide GEL TOPICAL 20080331 ANDA ANDA050557 Physicians Total Care, Inc. BENZOYL PEROXIDE; ERYTHROMYCIN 50; 30 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54868-5620_573b81a1-0a14-49d6-98a7-bb99be916201 54868-5620 HUMAN OTC DRUG Simethicone Simethicone SOLUTION/ DROPS ORAL 20071030 OTC MONOGRAPH FINAL part332 Physicians Total Care, Inc. DIMETHICONE; SILICON DIOXIDE 63.3; 3.7 mg/mL; mg/mL 54868-5621_96fd8eb0-93c6-4d08-ae0d-7b8fe4c44354 54868-5621 HUMAN PRESCRIPTION DRUG PULMICORT RESPULES Budesonide SUSPENSION RESPIRATORY (INHALATION) 20060629 NDA NDA020929 Physicians Total Care, Inc. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5622_fba49e33-36bd-48c5-8500-fd36b9cacb7c 54868-5622 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride LIQUID ORAL 20060629 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 54868-5623_a325acae-9aca-40b7-92f9-73e7b35a90cd 54868-5623 HUMAN OTC DRUG Ibuprofen Junior Ibuprofen TABLET, CHEWABLE ORAL 20071016 ANDA ANDA076359 Physicians Total Care, Inc. IBUPROFEN 100 mg/1 54868-5624_301ec476-d899-4616-be96-910bcb384d08 54868-5624 HUMAN OTC DRUG Acetaminophen Acetaminophen SUPPOSITORY RECTAL 20060629 NDA NDA018060 Physicians Total Care, Inc. ACETAMINOPHEN 120 mg/1 54868-5625_38049cd9-c84f-40a5-9f6c-b3a07c8170a3 54868-5625 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20060629 OTC MONOGRAPH FINAL part343 Physicians Total Care, Inc. ACETAMINOPHEN 80 mg/1 54868-5627_4896f77d-3d97-4ffa-ad89-e8bd4cf20feb 54868-5627 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20070202 ANDA ANDA076685 Physicians Total Care, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5628_4896f77d-3d97-4ffa-ad89-e8bd4cf20feb 54868-5628 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20080721 ANDA ANDA076685 Physicians Total Care, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5629_4896f77d-3d97-4ffa-ad89-e8bd4cf20feb 54868-5629 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20080708 ANDA ANDA076685 Physicians Total Care, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5630_4896f77d-3d97-4ffa-ad89-e8bd4cf20feb 54868-5630 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20070523 ANDA ANDA076685 Physicians Total Care, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5636_822f9e27-f5bb-49b0-b483-1403be8e8713 54868-5636 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20060630 ANDA ANDA077914 Physicians Total Care, Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 54868-5637_e545053a-9ad5-48f1-94c5-8ae86735e581 54868-5637 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20060705 NDA NDA021433 Physicians Total Care, Inc. FLUTICASONE PROPIONATE 220 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5638_fedbbda2-d131-494e-8375-fe4ebec9f87a 54868-5638 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20060912 NDA AUTHORIZED GENERIC NDA019839 Physicians Total Care, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-5639_fedbbda2-d131-494e-8375-fe4ebec9f87a 54868-5639 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20060824 NDA AUTHORIZED GENERIC NDA019839 Physicians Total Care, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-5642_9c8577a5-8492-49be-b6d9-c657beb86a90 54868-5642 HUMAN PRESCRIPTION DRUG MIRTAZAPINE Mirtazapine TABLET ORAL 20060714 ANDA ANDA076122 Physicians Total Care, Inc. MIRTAZAPINE 15 mg/1 54868-5643_969b3a71-6ed6-4604-a2aa-ab8fe3624bcb 54868-5643 HUMAN PRESCRIPTION DRUG Atripla efavirenz, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20121016 NDA NDA021937 Physicians Total Care, Inc. EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600; 200; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 54868-5644_db4326cd-862d-4710-9b4e-654efeb813cc 54868-5644 HUMAN PRESCRIPTION DRUG Potassium Citrate potassium citrate TABLET, EXTENDED RELEASE ORAL 20060724 ANDA ANDA077440 Physicians Total Care, Inc. POTASSIUM CITRATE 1080 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 54868-5645_ece7a755-6b4e-4cc9-938e-9106829ee4e0 54868-5645 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole SHAMPOO, SUSPENSION TOPICAL 20060724 ANDA ANDA076419 Physicians Total Care, Inc. KETOCONAZOLE 20 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 54868-5647_51f52100-ae0b-4308-bd2e-fd4e618c8dd4 54868-5647 HUMAN PRESCRIPTION DRUG Azithromycin azithromycin monohydrate POWDER, FOR SUSPENSION ORAL 20060801 ANDA ANDA050710 Physicians Total Care, Inc. AZITHROMYCIN 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54868-5648_51f52100-ae0b-4308-bd2e-fd4e618c8dd4 54868-5648 HUMAN PRESCRIPTION DRUG Azithromycin azithromycin monohydrate POWDER, FOR SUSPENSION ORAL 20060803 ANDA ANDA050710 Physicians Total Care, Inc. AZITHROMYCIN 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54868-5649_6fb833cd-9943-41b5-bd26-babf23ac106a 54868-5649 HUMAN PRESCRIPTION DRUG Rozerem ramelteon TABLET, FILM COATED ORAL 20060801 NDA NDA021782 Physicians Total Care, Inc. RAMELTEON 8 mg/1 Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA] 54868-5650_5944937d-4840-4562-a5ae-30825414ce0b 54868-5650 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060807 ANDA ANDA077927 Physicians Total Care, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-5651_5944937d-4840-4562-a5ae-30825414ce0b 54868-5651 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060807 ANDA ANDA077927 Physicians Total Care, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-5653_0b937ee5-f2c3-48a9-87d2-f0689ff39043 54868-5653 HUMAN PRESCRIPTION DRUG Advicor niacin and lovastatin TABLET, EXTENDED RELEASE ORAL 20060808 NDA NDA021249 Physicians Total Care, Inc. LOVASTATIN; NIACIN 40; 1000 mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5655_f3e68fe5-0af1-483f-be17-bea16fe9f1ba 54868-5655 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole CREAM TOPICAL 20060814 ANDA ANDA076408 Physicians Total Care, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 54868-5656_48bc8c82-3745-4f40-8728-5d0257d9b388 54868-5656 HUMAN OTC DRUG Loratadine and Pseudoephedrine loratadine and pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20080527 ANDA ANDA076557 Physicians Total Care, Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 54868-5657_58b3d93a-2c9f-4997-a5e9-663160d92fe4 54868-5657 HUMAN PRESCRIPTION DRUG Clobex clobetasol propionate LOTION TOPICAL 20060816 NDA NDA021535 Physicians Total Care, Inc. CLOBETASOL PROPIONATE .05 mL/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5658_fedbbda2-d131-494e-8375-fe4ebec9f87a 54868-5658 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20060816 NDA AUTHORIZED GENERIC NDA019839 Physicians Total Care, Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-5659_87471cb4-c33e-4146-acda-6a792ed2a4ba 54868-5659 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20060818 ANDA ANDA077828 Physicians Total Care, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 54868-5660_80ae2eaf-98af-4ca0-b6f8-d4ceb2c01e2b 54868-5660 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET ORAL 20060823 ANDA ANDA076509 Physicians Total Care, Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 54868-5662_cc07c7d6-d6d4-473a-8e5f-e64d1f1ae362 54868-5662 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20060829 NDA NDA021446 Physicians Total Care, Inc. PREGABALIN 25 mg/1 CV 54868-5663_ec9a9d82-9a1c-4334-a4e5-91fda1b140fa 54868-5663 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine hydrochloride CAPSULE ORAL 20071128 ANDA ANDA075658 Physicians Total Care, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-5664_c5e1380a-77e4-4ba7-8388-72beb76ac2fd 54868-5664 HUMAN PRESCRIPTION DRUG Chantix varenicline tartrate KIT 20060901 NDA NDA021928 Physicians Total Care, Inc. 54868-5667_888c6452-91db-433a-a32b-1c094b0fa551 54868-5667 HUMAN PRESCRIPTION DRUG Bromocriptine Mesylate bromocriptine mesylate TABLET ORAL 20060908 ANDA ANDA076962 Physicians Total Care, Inc. BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 54868-5670_4f15e43e-2be6-4f49-bf18-cfe8c8106f17 54868-5670 HUMAN PRESCRIPTION DRUG Acetylcysteine Acetylcysteine SOLUTION ORAL; RESPIRATORY (INHALATION) 20090629 ANDA ANDA072324 Physicians Total Care, Inc. ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 54868-5672_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-5672 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20060921 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 2.5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5673_8bda2b6b-e72d-4955-9fa2-27af10454d34 54868-5673 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20080324 BLA BLA103234 Physicians Total Care, Inc. ERYTHROPOIETIN 20000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 54868-5674_c5e1380a-77e4-4ba7-8388-72beb76ac2fd 54868-5674 HUMAN PRESCRIPTION DRUG Chantix varenicline tartrate TABLET, FILM COATED ORAL 20060901 NDA NDA021928 Physicians Total Care, Inc. VARENICLINE TARTRATE 1 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] 54868-5676_4d2f8129-74e5-4e84-8257-827b160a743d 54868-5676 HUMAN PRESCRIPTION DRUG Oracea doxycycline CAPSULE, DELAYED RELEASE PELLETS ORAL 20060929 ANDA ANDA050805 Physicians Total Care, Inc. DOXYCYCLINE 40 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 54868-5680_0bf4274a-5edc-4e6b-9e1e-22c3e4b1d60d 54868-5680 HUMAN PRESCRIPTION DRUG Taclonex calcipotriene and betamethasone dipropionate OINTMENT TOPICAL 20101020 NDA NDA021852 Physicians Total Care, Inc. BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE .5; 50 mg/g; ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5681_7b48908f-c899-4e5f-af2f-0ed42a48530a 54868-5681 HUMAN PRESCRIPTION DRUG FocalinXR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20061011 NDA NDA021802 Physicians Total Care, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-5682_7b48908f-c899-4e5f-af2f-0ed42a48530a 54868-5682 HUMAN PRESCRIPTION DRUG FocalinXR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20061011 NDA NDA021802 Physicians Total Care, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-5683_7b48908f-c899-4e5f-af2f-0ed42a48530a 54868-5683 HUMAN PRESCRIPTION DRUG FocalinXR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20061011 NDA NDA021802 Physicians Total Care, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-5684_7b48908f-c899-4e5f-af2f-0ed42a48530a 54868-5684 HUMAN PRESCRIPTION DRUG FocalinXR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20061011 NDA NDA021802 Physicians Total Care, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-5687_960b6700-d38f-48db-ac61-3d2d82e97bec 54868-5687 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir SUSPENSION ORAL 20061003 ANDA ANDA077026 Physicians Total Care, Inc. ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 54868-5689_09114222-c1d5-40eb-a1dd-d0072e0ee658 54868-5689 HUMAN PRESCRIPTION DRUG Xopenex HFA levalbuterol tartrate AEROSOL, METERED ORAL 20071001 NDA NDA021730 Physicians Total Care, Inc. LEVALBUTEROL TARTRATE 45 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 54868-5690_8a1277c4-9a11-4cc9-8a6b-aea181d8c75c 54868-5690 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20061010 NDA NDA020364 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-5691_5b56276f-13f7-4f04-9e9f-425574b69c2d 54868-5691 HUMAN PRESCRIPTION DRUG Phoslo Calcium Acetate CAPSULE ORAL 20100301 NDA NDA021160 Physicians Total Care, Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 54868-5692_fd2243fb-6150-4324-9466-84634f7f3b17 54868-5692 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate GEL TOPICAL 20061017 ANDA ANDA075276 Physicians Total Care, Inc. BETAMETHASONE DIPROPIONATE .64 mg/g 54868-5693_4c9f5ab5-825e-4937-9d7a-1c7f781fc728 54868-5693 HUMAN PRESCRIPTION DRUG Cefadroxil cefadroxil monohydrate POWDER, FOR SUSPENSION ORAL 20061019 ANDA ANDA065115 Physicians Total Care, Inc. CEFADROXIL 250 mg/5mL 54868-5694_4c9f5ab5-825e-4937-9d7a-1c7f781fc728 54868-5694 HUMAN PRESCRIPTION DRUG Cefadroxil cefadroxil monohydrate POWDER, FOR SUSPENSION ORAL 20070516 ANDA ANDA065115 Physicians Total Care, Inc. CEFADROXIL 500 mg/5mL 54868-5697_80ae2eaf-98af-4ca0-b6f8-d4ceb2c01e2b 54868-5697 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET ORAL 20061115 ANDA ANDA076509 Physicians Total Care, Inc. FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 54868-5699_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-5699 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20061102 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 2.5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-5701_e471506d-cd02-4fcc-acbd-bb881d13561a 54868-5701 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20070312 ANDA ANDA040517 Physicians Total Care, Inc. METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-5704_931dca5a-f555-459e-8f09-ae71f80b8960 54868-5704 HUMAN PRESCRIPTION DRUG Enablex darifenacin TABLET, EXTENDED RELEASE ORAL 20061106 NDA NDA021513 Physicians Total Care, Inc. DARIFENACIN 7.5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54868-5707_a4414e19-f9f5-42e3-9a4d-bf261a881f47 54868-5707 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride and naloxone hydrochloride TABLET SUBLINGUAL 20080707 NDA NDA020733 Physicians Total Care, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 54868-5708_953e45fd-753e-41bb-9295-813476e9b6ed 54868-5708 HUMAN PRESCRIPTION DRUG Clarinex-D 12 Hour desloratadine and pseudoephedrine sulfate TABLET, EXTENDED RELEASE ORAL 20061129 NDA NDA021313 Physicians Total Care, Inc. DESLORATADINE; PSEUDOEPHEDRINE SULFATE 2.5; 120 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] CV 54868-5709_1b4f9d70-940c-4e94-acc9-7871532ec575 54868-5709 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20070426 ANDA ANDA076355 Physicians Total Care, Inc. ALBUTEROL SULFATE 1.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 54868-5711_e823e111-98c5-403e-a2e8-9012784e0fab 54868-5711 HUMAN PRESCRIPTION DRUG MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20061212 ANDA ANDA075243 Physicians Total Care, Inc. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-5712_eb12bd6a-9815-4687-8ac7-0bb533fe0137 54868-5712 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20061207 ANDA ANDA074686 Physicians Total Care, Inc. GLYBURIDE 1.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 54868-5715_f477bd89-5008-49c7-93ac-7ca6d3a14e2f 54868-5715 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION INTRAVENOUS 20061211 ANDA ANDA076589 Physicians Total Care, Inc. FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 54868-5717_ecd0523c-6fef-4437-90af-23719e7aaf40 54868-5717 HUMAN PRESCRIPTION DRUG Dobutamine Dobutamine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20061211 ANDA ANDA074292 Physicians Total Care, Inc. DOBUTAMINE HYDROCHLORIDE 12.5 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 54868-5722_c883618f-76da-466a-b7b1-26c96e7b4a45 54868-5722 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride amiodarone hydrochloride INJECTION, SOLUTION INTRAVENOUS 20061211 ANDA ANDA076217 Physicians Total Care, Inc. AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 54868-5724_86cf14f4-6d39-4e6d-9ea2-ba4352f3a59d 54868-5724 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20061212 ANDA ANDA075151 Physicians Total Care, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 54868-5725_05fad6bc-4d30-4a82-8a9e-e9d90ba67988 54868-5725 HUMAN PRESCRIPTION DRUG EPINEPHRINE epinephrine INJECTION, SOLUTION INTRACARDIAC; INTRAVENOUS 20061211 NDA NDA020800 Physicians Total Care, Inc. EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 54868-5726_caef8a69-1e3e-4ee2-81e8-d6f5e8ec5f74 54868-5726 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE metoprolol tartrate INJECTION, SOLUTION INTRAVENOUS 20061211 ANDA ANDA076495 Physicians Total Care, Inc. METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-5728_155eb93c-b3dd-48af-bf1a-6ff094cb5d20 54868-5728 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20061212 ANDA ANDA076644 Physicians Total Care, Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54868-5729_8ad0fad9-c989-46e1-9714-522695bc99ca 54868-5729 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080206 ANDA ANDA076969 Physicians Total Care, Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-5730_8ad0fad9-c989-46e1-9714-522695bc99ca 54868-5730 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070803 ANDA ANDA076969 Physicians Total Care, Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-5731_8ad0fad9-c989-46e1-9714-522695bc99ca 54868-5731 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100105 ANDA ANDA076969 Physicians Total Care, Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-5732_8ad0fad9-c989-46e1-9714-522695bc99ca 54868-5732 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070731 ANDA ANDA076969 Physicians Total Care, Inc. METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-5736_5157468f-8f49-4746-a2c2-91a2020537e3 54868-5736 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Extended Release (XL) bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20090723 ANDA ANDA077715 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 54868-5738_c985cb6d-5594-4fb2-9718-f736e991792d 54868-5738 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20061229 ANDA ANDA077050 Physicians Total Care, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 54868-5741_e802c8a3-ae8b-41be-a3c4-a8fe44a2fd0a 54868-5741 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE ORAL 20070105 ANDA ANDA076570 Physicians Total Care, Inc. TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 54868-5742_155eb93c-b3dd-48af-bf1a-6ff094cb5d20 54868-5742 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070108 ANDA ANDA076702 Physicians Total Care, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54868-5743_ded983e5-8794-4330-941d-a10de942c5ed 54868-5743 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 20100113 ANDA ANDA078293 Physicians Total Care, Inc. OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54868-5746_898c5e2b-1c01-486f-a82e-0345fd3c5575 54868-5746 HUMAN PRESCRIPTION DRUG MIRAPEX pramipexole dihydrochloride TABLET ORAL 20070109 NDA NDA020667 Physicians Total Care, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 54868-5749_a37afd6e-cb80-4908-8ed9-cb50eef30c57 54868-5749 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070116 ANDA ANDA078050 Physicians Total Care, Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 54868-5750_a4414e19-f9f5-42e3-9a4d-bf261a881f47 54868-5750 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride and naloxone hydrochloride TABLET SUBLINGUAL 20070116 NDA NDA020733 Physicians Total Care, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 54868-5751_c0650ef0-3b4f-44aa-83e9-70111fa25ed1 54868-5751 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SPRAY, METERED NASAL 20070124 ANDA ANDA076025 Physicians Total Care, Inc. IPRATROPIUM BROMIDE 21 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 54868-5754_ea19bd36-7cb9-4836-b1f3-a2b6c852906e 54868-5754 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20070202 ANDA ANDA078627 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-5755_8fb54677-a6b7-4c9d-88fb-f7abc1ba13e5 54868-5755 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol CAPSULE, EXTENDED RELEASE ORAL 20070205 ANDA ANDA078065 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 54868-5756_f0ec7dd9-476e-4705-a48f-ea90942be3fd 54868-5756 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET ORAL 20070205 ANDA ANDA065276 Physicians Total Care, Inc. CEFPROZIL 500 mg/1 54868-5757_66c7c968-7156-4edb-9094-bb0da3c1bd18 54868-5757 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20070205 ANDA ANDA065261 Physicians Total Care, Inc. CEFPROZIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54868-5759_fa3f43fa-ff9a-49ae-9127-3a141af355d4 54868-5759 HUMAN PRESCRIPTION DRUG SPRYCEL dasatinib TABLET ORAL 20070212 NDA NDA021986 Physicians Total Care, Inc. DASATINIB 70 mg/1 54868-5761_dbf80a69-a5e3-4816-8665-2ddc41d8a953 54868-5761 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070328 ANDA ANDA078552 Physicians Total Care, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54868-5762_dbf80a69-a5e3-4816-8665-2ddc41d8a953 54868-5762 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070328 ANDA ANDA078552 Physicians Total Care, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54868-5764_dbf80a69-a5e3-4816-8665-2ddc41d8a953 54868-5764 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070406 ANDA ANDA078552 Physicians Total Care, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54868-5765_929a6a1f-8668-425d-aec4-15793be80ea7 54868-5765 HUMAN PRESCRIPTION DRUG Lantus insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20070404 NDA NDA021081 Physicians Total Care, Inc. INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 54868-5767_2ad2ae6f-7822-46d0-9ffc-32a9c273bf17 54868-5767 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20070508 ANDA ANDA065434 Physicians Total Care, Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54868-5768_c21f3dae-e96c-49ee-8177-c9dba8ee73ad 54868-5768 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070508 ANDA ANDA065473 Physicians Total Care, Inc. CEFDINIR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54868-5769_c21f3dae-e96c-49ee-8177-c9dba8ee73ad 54868-5769 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070509 ANDA ANDA065473 Physicians Total Care, Inc. CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 54868-5770_bbdc7912-ae9e-4c73-bbdf-6dd17d0c53f0 54868-5770 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine Hydrochloride SOLUTION ORAL 20071003 ANDA ANDA091078 Physicians Total Care, Inc. RANITIDINE HYDROCHLORIDE 150 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 54868-5771_887b9788-8ac1-4e6e-9b2e-8c0e79dcd023 54868-5771 HUMAN PRESCRIPTION DRUG COREGCR CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070523 NDA NDA022012 Physicians Total Care, Inc. CARVEDILOL PHOSPHATE 80 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 54868-5772_a742bba8-ee3a-4e5b-b670-ea31c4633b3e 54868-5772 HUMAN PRESCRIPTION DRUG Tekturna aliskiren hemifumarate TABLET, FILM COATED ORAL 20070523 NDA NDA021985 Physicians Total Care, Inc. ALISKIREN HEMIFUMARATE 150 mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA] 54868-5773_59a95728-34a6-4741-8807-cba7da17e1ab 54868-5773 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090812 ANDA ANDA078332 Physicians Total Care, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 54868-5774_96fd8eb0-93c6-4d08-ae0d-7b8fe4c44354 54868-5774 HUMAN PRESCRIPTION DRUG PULMICORT RESPULES Budesonide SUSPENSION RESPIRATORY (INHALATION) 20070601 NDA NDA020929 Physicians Total Care, Inc. BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5776_87471cb4-c33e-4146-acda-6a792ed2a4ba 54868-5776 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20070608 ANDA ANDA077828 Physicians Total Care, Inc. CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 54868-5777_d1873a74-56e6-4a01-8e4d-875789e5e344 54868-5777 HUMAN PRESCRIPTION DRUG Dobutamine Hydrochloride Dobutamine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20070613 NDA NDA020201 Physicians Total Care, Inc. DOBUTAMINE HYDROCHLORIDE 400 mg/100mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 54868-5780_745ce298-abcb-4d11-8c0e-79776cdc6e2e 54868-5780 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20070615 NDA NDA020818 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5781_992a5cba-0854-4367-b5fe-60cddbb3c348 54868-5781 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20071026 ANDA ANDA078466 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-5782_992a5cba-0854-4367-b5fe-60cddbb3c348 54868-5782 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20070626 ANDA ANDA078466 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-5783_8a1277c4-9a11-4cc9-8a6b-aea181d8c75c 54868-5783 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20070620 NDA NDA020364 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-5787_16c2a7ef-99f3-4b11-a4fd-a90471a7fddf 54868-5787 HUMAN PRESCRIPTION DRUG Captopril and Hydrochlorothiazide Captopril and Hydrochlorothiazide TABLET ORAL 20070712 ANDA ANDA074896 Physicians Total Care, Inc. CAPTOPRIL; HYDROCHLOROTHIAZIDE 25; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-5788_b5f46d0d-6971-4954-96ca-01bd0faa52eb 54868-5788 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070713 ANDA ANDA086242 Physicians Total Care, Inc. HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 54868-5789_afc7725d-445d-42bf-b41c-f4614121710b 54868-5789 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20070711 ANDA ANDA077634 Physicians Total Care, Inc. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-5792_992a5cba-0854-4367-b5fe-60cddbb3c348 54868-5792 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20070628 ANDA ANDA078466 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-5793_992a5cba-0854-4367-b5fe-60cddbb3c348 54868-5793 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100816 ANDA ANDA078466 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-5794_11e46c02-ed18-442d-8281-3c9d49eec7a5 54868-5794 HUMAN PRESCRIPTION DRUG Terbinafine Hydochloride terbinafine hydrochloride TABLET ORAL 20070712 ANDA ANDA078199 Physicians Total Care, Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 54868-5795_183fd856-868e-459a-8361-66ca5ac363e3 54868-5795 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20070711 NDA NDA021428 Physicians Total Care, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 54868-5799_91d78653-caeb-4360-a9b0-d31b4aec2f93 54868-5799 HUMAN PRESCRIPTION DRUG Ergocalciferol ergocalciferol CAPSULE ORAL 20070712 ANDA ANDA040833 Physicians Total Care, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 54868-5801_c985cb6d-5594-4fb2-9718-f736e991792d 54868-5801 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070730 ANDA ANDA077050 Physicians Total Care, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 54868-5802_8bda2b6b-e72d-4955-9fa2-27af10454d34 54868-5802 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20070813 BLA BLA103234 Physicians Total Care, Inc. ERYTHROPOIETIN 40000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 54868-5804_99fc81a8-679b-46b6-900f-7207a878f6df 54868-5804 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20070815 NDA NDA021990 Physicians Total Care, Inc. AMLODIPINE BESYLATE; VALSARTAN 10; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-5808_2ed9b59c-40be-4140-aa8e-1584dcd09329 54868-5808 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20070821 NDA NDA021171 Physicians Total Care, Inc. MEPERIDINE HYDROCHLORIDE 50 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-5809_0ba46c78-f90c-4c2b-9712-3a6cae5f0a44 54868-5809 HUMAN PRESCRIPTION DRUG SELZENTRY Maraviroc TABLET, FILM COATED ORAL 20071219 NDA NDA022128 Physicians Total Care, Inc. MARAVIROC 300 mg/1 CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] 54868-5812_9c8577a5-8492-49be-b6d9-c657beb86a90 54868-5812 HUMAN PRESCRIPTION DRUG MIRTAZAPINE Mirtazapine TABLET ORAL 20070823 ANDA ANDA076122 Physicians Total Care, Inc. MIRTAZAPINE 45 mg/1 54868-5814_e1db502f-fa92-4a34-9c93-68bdfb38ba85 54868-5814 HUMAN PRESCRIPTION DRUG Androgel Testosterone GEL TRANSDERMAL 20070829 NDA NDA021015 Physicians Total Care, Inc. TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 54868-5816_70282b0a-c6a1-4653-bf8d-89d1ce7a1d67 54868-5816 HUMAN PRESCRIPTION DRUG Lovaza omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20081211 NDA NDA021654 Physicians Total Care, Inc. OMEGA-3-ACID ETHYL ESTERS 1 g/1 54868-5817_59a95728-34a6-4741-8807-cba7da17e1ab 54868-5817 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070917 ANDA ANDA078332 Physicians Total Care, Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 54868-5819_4c00b6f1-aefd-49a6-a0fd-5899be30ba6d 54868-5819 HUMAN OTC DRUG NICOTINE Transdermal System Step 3 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20070919 NDA NDA020076 Physicians Total Care, Inc. NICOTINE 7 mg/24h 54868-5820_7363d401-12e0-4570-9747-1bdec4646d63 54868-5820 HUMAN OTC DRUG NICOTINE Transdermal System Step 2 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20070919 NDA NDA020076 Physicians Total Care, Inc. NICOTINE 14 mg/24h 54868-5821_535f1e93-ce29-4921-98ac-f9c8aa99db75 54868-5821 HUMAN OTC DRUG NICOTINE Transdermal System Step 1 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20070919 NDA NDA020076 Physicians Total Care, Inc. NICOTINE 21 mg/24h 54868-5826_d54c3b62-6791-4f4c-b3cb-47e54aef1b1f 54868-5826 HUMAN PRESCRIPTION DRUG TriNessa norgestimate and ethinyl estradiol KIT 20071030 NDA NDA019697 Physicians Total Care, Inc. 54868-5827_10e3f643-f415-4646-bb59-60ca369f9bb2 54868-5827 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20080711 NDA NDA021977 Physicians Total Care, Inc. LISDEXAMFETAMINE DIMESYLATE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-5828_89be2fdc-f44c-4b37-9200-a0a68039a92c 54868-5828 HUMAN PRESCRIPTION DRUG Yaz Drospirenone and ethinyl estradiol KIT 20071102 NDA NDA021676 Physicians Total Care, Inc. 54868-5829_8b3759e9-e20f-433d-acdb-173863e2b2ae 54868-5829 HUMAN PRESCRIPTION DRUG Xyzal levocetirizine dihydrochloride TABLET ORAL 20071106 NDA NDA022064 Physicians Total Care, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 54868-5830_f10bdd5f-6af1-4f57-ac08-c5627263ac51 54868-5830 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071114 ANDA ANDA077802 Physicians Total Care, Inc. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-5831_074a2f68-402f-4481-8ba6-c9b2fd3b5890 54868-5831 HUMAN PRESCRIPTION DRUG Precose Acarbose TABLET ORAL 20071119 NDA NDA020482 Physicians Total Care, Inc. ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 54868-5833_c7d8df9e-f779-425d-9fca-74e444bcd864 54868-5833 HUMAN PRESCRIPTION DRUG Cleocin clindamycin palmitate hydrochloride GRANULE, FOR SOLUTION ORAL 20071128 ANDA ANDA061772 Physicians Total Care, Inc. CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 54868-5834_3cf776ce-c44d-4a33-ad21-bb128fcde089 54868-5834 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 20071128 ANDA ANDA081203 Physicians Total Care, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5835_cf63553d-cb67-44c0-8c5f-44683f9a30ac 54868-5835 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20071129 NDA NDA020164 Physicians Total Care, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 54868-5836_199662a5-c92a-43ca-88ff-38e30bc6c3b9 54868-5836 HUMAN PRESCRIPTION DRUG Humalog Cartridge Insulin lispro INJECTION, SOLUTION SUBCUTANEOUS 20071203 NDA NDA020563 Physicians Total Care, Inc. INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 54868-5837_cf63553d-cb67-44c0-8c5f-44683f9a30ac 54868-5837 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20071204 NDA NDA020164 Physicians Total Care, Inc. ENOXAPARIN SODIUM 120 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 54868-5838_e59e8cfa-c250-483e-b545-d37e1b4baf8b 54868-5838 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR SULFATE CAPSULE, GELATIN COATED ORAL 20071204 NDA NDA021567 Physicians Total Care, Inc. ATAZANAVIR SULFATE 300 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 54868-5839_7c89711c-07e8-404e-9946-bdaefdff3df1 54868-5839 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20071204 NDA NDA020823 Physicians Total Care, Inc. RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 54868-5840_9a1183ca-11db-4b18-9ab4-acb2a7f18e44 54868-5840 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20071213 NDA NDA021995 Physicians Total Care, Inc. SITAGLIPTIN PHOSPHATE 100 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 54868-5841_cf206f2d-793d-4301-a75a-ed2b1d90ba4c 54868-5841 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071220 ANDA ANDA078306 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-5842_e57cd5e0-8294-439b-8b64-ea60d10bb4d0 54868-5842 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20090730 ANDA ANDA076549 Physicians Total Care, Inc. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-5843_e57cd5e0-8294-439b-8b64-ea60d10bb4d0 54868-5843 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20080221 ANDA ANDA076549 Physicians Total Care, Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-5844_e7392f6d-0179-49a5-b670-fb6f2a9c7db0 54868-5844 HUMAN PRESCRIPTION DRUG PULMICORT FLEXHALER Budesonide AEROSOL, POWDER RESPIRATORY (INHALATION) 20071228 NDA NDA021949 Physicians Total Care, Inc. BUDESONIDE 180 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5845_5763c697-2e4b-460c-9815-38f8de8cf9b6 54868-5845 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20080102 ANDA ANDA077946 Physicians Total Care, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 54868-5846_1598c85f-10aa-4d0c-a631-6ddf886a8a1b 54868-5846 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20080102 ANDA ANDA077056 Physicians Total Care, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 54868-5847_90123dd1-81e6-42b2-ac2e-c5bae2ed20f7 54868-5847 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET ORAL 20080107 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. GUAIFENESIN 200 mg/1 54868-5849_923d0972-3956-4c62-85b2-d75abcdefb2d 54868-5849 HUMAN OTC DRUG Mucinex D Guaifenesin and pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20080107 NDA NDA021585 Physicians Total Care, Inc. GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 54868-5850_8ea73dd1-dfe3-4628-940f-16587e605fcb 54868-5850 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20080116 NDA NDA020616 Physicians Total Care, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-5853_558086c7-d31d-4e1d-b40c-83bec73cd5f4 54868-5853 HUMAN OTC DRUG Mucinex DM Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20080123 NDA NDA021620 Physicians Total Care, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30; 600 mg/1; mg/1 54868-5854_2a0dd457-4727-47ff-9268-e9e1b9d17b30 54868-5854 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 20080124 NDA NDA020475 Physicians Total Care, Inc. TRETINOIN 400 mL/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-5855_6ffa08b1-f48a-45b8-95ce-9ed2672c4902 54868-5855 HUMAN OTC DRUG Cetirizine Hydrochloride cetirizine hydrochloride TABLET, FILM COATED ORAL 20080129 ANDA ANDA076677 Physicians Total Care, Inc. CETIRIZINE HYDROCHLORIDE 5 mg/1 54868-5856_e57cd5e0-8294-439b-8b64-ea60d10bb4d0 54868-5856 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20080213 ANDA ANDA076549 Physicians Total Care, Inc. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-5857_e44e8fd8-fa4f-40e4-b7b6-8b3742e29f61 54868-5857 HUMAN PRESCRIPTION DRUG QVAR beclomethasone dipropionate AEROSOL, METERED RESPIRATORY (INHALATION) 20080129 NDA NDA020911 Physicians Total Care, Inc. BECLOMETHASONE DIPROPIONATE 40 ug/1 54868-5858_e44e8fd8-fa4f-40e4-b7b6-8b3742e29f61 54868-5858 HUMAN PRESCRIPTION DRUG QVAR beclomethasone dipropionate AEROSOL, METERED RESPIRATORY (INHALATION) 20080129 NDA NDA020911 Physicians Total Care, Inc. BECLOMETHASONE DIPROPIONATE 80 ug/1 54868-5859_f7504dcb-f6f9-4b13-bc3f-73ca2b5aaeeb 54868-5859 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20080501 ANDA ANDA090182 Physicians Total Care, Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL 54868-5860_931ba10d-c87b-4c19-be15-7361176ed1b8 54868-5860 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080207 ANDA ANDA075710 Physicians Total Care, Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 54868-5861_931ba10d-c87b-4c19-be15-7361176ed1b8 54868-5861 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080207 ANDA ANDA075710 Physicians Total Care, Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 54868-5862_931ba10d-c87b-4c19-be15-7361176ed1b8 54868-5862 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080211 ANDA ANDA075710 Physicians Total Care, Inc. ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 54868-5864_26d15de0-e8b5-4f82-9c43-624f7f510a6a 54868-5864 HUMAN PRESCRIPTION DRUG Intelence etravirine TABLET ORAL 20080221 NDA NDA022187 Physicians Total Care, Inc. ETRAVIRINE 100 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] 54868-5865_026db3f4-9b34-4b2a-9f95-07ccce7c5685 54868-5865 HUMAN OTC DRUG Pramoxine Hydrochloride pramoxine hydrochloride AEROSOL, FOAM RECTAL 20080222 OTC MONOGRAPH FINAL part346 Physicians Total Care, Inc. PRAMOXINE HYDROCHLORIDE 150 mg/15g 54868-5869_887b9788-8ac1-4e6e-9b2e-8c0e79dcd023 54868-5869 HUMAN PRESCRIPTION DRUG COREGCR CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20080509 NDA NDA022012 Physicians Total Care, Inc. CARVEDILOL PHOSPHATE 40 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 54868-5870_b6744211-555b-4401-9b41-d503e9465ac2 54868-5870 HUMAN OTC DRUG Aquaphor Petrolatum OINTMENT TOPICAL 20080328 OTC MONOGRAPH FINAL part347 Physicians Total Care, Inc. PETROLATUM 41 g/100g 54868-5875_c88a4047-8d8c-4ce7-911a-4dcd6cb4baf1 54868-5875 HUMAN OTC DRUG Aveeno Dimethicone LOTION TOPICAL 20080331 OTC MONOGRAPH FINAL part347 Physicians Total Care, Inc. DIMETHICONE 13 mg/g 54868-5876_2a573d66-a2c7-4c16-a744-2aea84a730b9 54868-5876 HUMAN OTC DRUG Zeasorb AF miconazole nitrate POWDER TOPICAL 20080331 OTC MONOGRAPH FINAL part333C Physicians Total Care, Inc. MICONAZOLE NITRATE 20.6 mg/g 54868-5879_8e580ba8-f7c1-4ba1-9b4b-d6c7a21d12d5 54868-5879 HUMAN OTC DRUG ZYRTEC D Allergy and Congestion Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20080328 NDA NDA021150 Physicians Total Care, Inc. CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 54868-5882_030c1db3-fbce-4963-bc60-7438d927c8b4 54868-5882 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole LOTION TOPICAL 20080327 ANDA ANDA077197 Physicians Total Care, Inc. METRONIDAZOLE 7.5 mg/mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 54868-5883_baf2526e-303d-4178-a7e5-82c77e7f8a6f 54868-5883 HUMAN PRESCRIPTION DRUG Levemir insulin detemir INJECTION, SOLUTION SUBCUTANEOUS 20080331 NDA NDA021536 Physicians Total Care, Inc. INSULIN DETEMIR 14.2 mg/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 54868-5884_6f6eac97-fbc3-44a5-a6f4-fba3e559f664 54868-5884 HUMAN OTC DRUG Cetirizine HCl and Pseudoephedrine HCl ER Cetirizine HCl and Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080331 ANDA ANDA077991 Physicians Total Care, Inc. CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 CV 54868-5886_85d265f2-9b74-42d3-9b33-c34573be8c1e 54868-5886 HUMAN PRESCRIPTION DRUG Simcor simvastatin and niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080505 NDA NDA022078 Physicians Total Care, Inc. NIACIN; SIMVASTATIN 500; 20 mg/1; mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 54868-5887_a37afd6e-cb80-4908-8ed9-cb50eef30c57 54868-5887 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20080508 ANDA ANDA078050 Physicians Total Care, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 54868-5888_e64419f7-490f-4643-bb8c-7e171c8c8c15 54868-5888 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION INTRAVENOUS 20080508 ANDA ANDA076781 Physicians Total Care, Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 54868-5889_f849b89b-f428-48c3-a779-463e444ec8ce 54868-5889 HUMAN PRESCRIPTION DRUG OsmoPrep SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUS TABLET ORAL 20080530 NDA NDA021892 Physicians Total Care, Inc. SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .398; 1.102 g/1; g/1 54868-5890_ff3c9070-c458-4917-97a8-39c11edddd36 54868-5890 HUMAN PRESCRIPTION DRUG MOVIPREP POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE and ASCORBIC ACID KIT 20080530 NDA NDA021881 Physicians Total Care, Inc. 54868-5891_61037334-857a-4ea4-b74c-88898aafa28f 54868-5891 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 20080508 ANDA ANDA074286 Physicians Total Care, Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5893_23b070b1-1411-4a78-8b05-136d854c7df2 54868-5893 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone LOTION TOPICAL 20080508 ANDA ANDA089074 Physicians Total Care, Inc. HYDROCORTISONE 25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5896_e57cd5e0-8294-439b-8b64-ea60d10bb4d0 54868-5896 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20080714 ANDA ANDA076549 Physicians Total Care, Inc. RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-5897_af99b509-0cf2-40cb-9198-40414a82ca46 54868-5897 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20080521 ANDA ANDA078230 Physicians Total Care, Inc. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 54868-5899_199662a5-c92a-43ca-88ff-38e30bc6c3b9 54868-5899 HUMAN PRESCRIPTION DRUG Humalog Pen Insulin lispro INJECTION, SOLUTION SUBCUTANEOUS 20080512 NDA NDA020563 Physicians Total Care, Inc. INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 54868-5900_375b89df-4150-4279-a973-2eadb132a225 54868-5900 HUMAN PRESCRIPTION DRUG Dihydrocodeine Bitartrate, Acetaminophen and Caffeine Dihydrocodeine Bitartrate, Acetaminophen and Caffeine TABLET ORAL 20080520 ANDA ANDA040701 Physicians Total Care, Inc. ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 712.8; 60; 32 mg/1; mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 54868-5901_262588dd-98d4-4859-8ea6-032744c9a832 54868-5901 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20081107 ANDA ANDA078428 Physicians Total Care, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-5902_69c62db2-25f0-4f7e-937d-8a52e457ee49 54868-5902 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET ORAL 20080606 ANDA ANDA077290 Physicians Total Care, Inc. OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-5903_537cd838-05f2-44f4-aeb2-89c42f153e3c 54868-5903 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20080530 ANDA ANDA088316 Physicians Total Care, Inc DEXAMETHASONE 6 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5904_85d265f2-9b74-42d3-9b33-c34573be8c1e 54868-5904 HUMAN PRESCRIPTION DRUG Simcor simvastatin and niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080605 NDA NDA022078 Physicians Total Care, Inc. NIACIN; SIMVASTATIN 1000; 20 mg/1; mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 54868-5905_6b06a2a1-91d7-492c-8437-64c4fe5470f2 54868-5905 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20080616 ANDA ANDA077487 Physicians Total Care, Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 54868-5907_85d265f2-9b74-42d3-9b33-c34573be8c1e 54868-5907 HUMAN PRESCRIPTION DRUG Simcor simvastatin and niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080624 NDA NDA022078 Physicians Total Care, Inc. NIACIN; SIMVASTATIN 750; 20 mg/1; mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 54868-5908_9a40abe9-6936-4452-8546-f3ed99c2bab6 54868-5908 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080619 ANDA ANDA078829 Physicians Total Care, Inc. ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 54868-5909_9a40abe9-6936-4452-8546-f3ed99c2bab6 54868-5909 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080619 ANDA ANDA078829 Physicians Total Care, Inc. ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 54868-5911_e4bf8c4e-edd9-4cdb-ae48-48fa35bb4bcf 54868-5911 HUMAN OTC DRUG Omeprazole omeprazole TABLET, DELAYED RELEASE ORAL 20080619 NDA NDA022032 Physicians Total Care, Inc. OMEPRAZOLE 20 mg/1 54868-5912_af99b509-0cf2-40cb-9198-40414a82ca46 54868-5912 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20080627 ANDA ANDA078230 Physicians Total Care, Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 54868-5913_6a95d07c-a9d4-4fbc-b1c0-9b323edfb778 54868-5913 HUMAN OTC DRUG Clemastine Fumarate Clemastine Fumarate TABLET ORAL 20080627 ANDA ANDA073458 Physicians Total Care, Inc. CLEMASTINE FUMARATE 1.34 mg/1 54868-5914_af99b509-0cf2-40cb-9198-40414a82ca46 54868-5914 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20080702 ANDA ANDA078230 Physicians Total Care, Inc. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 54868-5915_d67caab0-2ebd-4d80-a415-2e329fb5a34e 54868-5915 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 20080708 ANDA ANDA072735 Physicians Total Care, Inc. LEUCOVORIN CALCIUM 15 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 54868-5916_10e3f643-f415-4646-bb59-60ca369f9bb2 54868-5916 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20080711 NDA NDA021977 Physicians Total Care, Inc. LISDEXAMFETAMINE DIMESYLATE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-5918_c031d46a-1f80-4600-ab2e-ff0b6e267e2a 54868-5918 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 20080723 ANDA ANDA079088 Physicians Total Care, Inc RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 54868-5921_803d538c-3eeb-4c67-97a1-40da1861fc84 54868-5921 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20080730 ANDA ANDA076388 Physicians Total Care, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 54868-5922_b6b00292-9230-43f4-8d2b-7aa1f13d734d 54868-5922 HUMAN PRESCRIPTION DRUG OCELLA drospirenone and ethinyl estradiol KIT 20080731 NDA NDA021098 Physicians Total Care, Inc. 54868-5926_2a0dd457-4727-47ff-9268-e9e1b9d17b30 54868-5926 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 20080808 NDA NDA020475 Physicians Total Care, Inc. TRETINOIN 1 mL/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-5927_5157468f-8f49-4746-a2c2-91a2020537e3 54868-5927 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Extended Release (XL) bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20080813 ANDA ANDA077715 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 54868-5928_d3ca750e-3050-4214-aea8-cffa33a2d61a 54868-5928 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET ORAL 20080814 ANDA ANDA078454 Physicians Total Care, Inc. MOEXIPRIL HYDROCHLORIDE 7.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-5929_86ad6d8b-e912-4eb3-94b1-6ede128d3e45 54868-5929 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20080819 ANDA ANDA078292 Physicians Total Care, Inc. DRONABINOL 5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 54868-5930_190ac700-81ee-4cba-b80c-a686bae27178 54868-5930 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20080819 ANDA ANDA076577 Physicians Total Care, Inc. MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 54868-5931_7d69deb0-58a5-4a54-84e5-96caa2fb7003 54868-5931 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080829 ANDA ANDA079051 Physicians Total Care, Inc. NISOLDIPINE 40 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 54868-5932_7aa51422-650b-4436-b57a-ec2e27cf7346 54868-5932 HUMAN PRESCRIPTION DRUG BICILLIN CR penicillin G benzathine and penicillin G procaine INJECTION, SUSPENSION INTRAMUSCULAR 20080828 NDA NDA050138 Physicians Total Care, Inc. PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE 600000; 600000 [iU]/2mL; [iU]/2mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 54868-5934_b02b798f-01b7-491e-8802-11057828e6f6 54868-5934 HUMAN PRESCRIPTION DRUG Menest Estrogens, esterified TABLET ORAL 20080905 ANDA ANDA084948 Physicians Total Care, Inc. ESTROGENS, ESTERIFIED .625 mg/1 54868-5935_01fd5716-bb59-49b0-a0ed-8da299cf060f 54868-5935 HUMAN PRESCRIPTION DRUG Junel Fe 1.5/30 norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20080902 ANDA ANDA076064 Physicians Total Care, Inc. 54868-5938_88c1b159-4dbc-44f6-adbd-edc267640625 54868-5938 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 20080908 NDA NDA050693 Physicians Total Care, Inc. AZITHROMYCIN DIHYDRATE 1 g/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54868-5942_62281903-f98d-4903-9a63-b54ba4842b16 54868-5942 HUMAN PRESCRIPTION DRUG Kelnor 1/35 ethynodiol diacetate and ethinyl estradiol KIT 20080916 ANDA ANDA076785 Physicians Total Care, Inc. 54868-5944_b9d62f7c-cb41-4b19-b488-a88ff08b1baa 54868-5944 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20081002 NDA NDA021742 Physicians Total Care, Inc. NEBIVOLOL HYDROCHLORIDE 5 mg/1 54868-5945_337c0383-46b3-4f8a-929b-3d650eac3634 54868-5945 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20081003 ANDA ANDA078470 Physicians Total Care, Inc. ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 54868-5950_c92c4adf-6ff2-4eda-a868-b0af18b08ae6 54868-5950 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride TABLET, FILM COATED ORAL 20081009 ANDA ANDA075998 Physicians Total Care, Inc. PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] 54868-5951_2c717d2f-6a42-44cd-815f-3efe43cce3c8 54868-5951 HUMAN PRESCRIPTION DRUG Lexapro escitalopram oxalate TABLET ORAL 20091130 NDA NDA021323 Physicians Total Care, Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-5952_af99b509-0cf2-40cb-9198-40414a82ca46 54868-5952 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20081022 ANDA ANDA078230 Physicians Total Care, Inc. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 54868-5953_af99b509-0cf2-40cb-9198-40414a82ca46 54868-5953 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20081022 ANDA ANDA078230 Physicians Total Care, Inc. ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 54868-5954_7cccdc96-0f15-4755-9d18-9d74f55a815c 54868-5954 HUMAN PRESCRIPTION DRUG Exelon rivastigmine PATCH, EXTENDED RELEASE TRANSDERMAL 20081014 NDA NDA022083 Physicians Total Care, Inc. RIVASTIGMINE 9.5 mg/24[USP'U] Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 54868-5955_803d538c-3eeb-4c67-97a1-40da1861fc84 54868-5955 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20081205 ANDA ANDA076388 Physicians Total Care, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 54868-5956_e899df9b-095c-4c16-895f-3307f9810383 54868-5956 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20081023 NDA NDA021368 Physicians Total Care, Inc. TADALAFIL 5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 54868-5957_6a8cd103-424c-4edc-ae29-3965f1d5a6bb 54868-5957 HUMAN PRESCRIPTION DRUG TUSSICAPS hydrocodone polistirex and chlorpheniramine polistirex CAPSULE, EXTENDED RELEASE ORAL 20081027 ANDA ANDA077273 Physicians Total Care, Inc. CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE 8; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CIII 54868-5958_a493f5ce-fdb0-400a-a1f0-fba66755f779 54868-5958 HUMAN PRESCRIPTION DRUG DIFFERIN adapalene GEL TOPICAL 20081024 NDA NDA021753 Physicians Total Care, Inc. ADAPALENE 3 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-5962_3d658b37-9931-4156-871a-e34e36b3dc35 54868-5962 HUMAN PRESCRIPTION DRUG Flector Diclofenac Epolamine PATCH TOPICAL 20081117 ANDA ANDA021234 Physicians Total Care, Inc. DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-5963_0825579e-56f9-4c3a-8c17-3a60abdc225d 54868-5963 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20081118 ANDA ANDA076258 Physicians Total Care, Inc. FENTANYL 1.28 mg/[USP'U] Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-5964_8ea73dd1-dfe3-4628-940f-16587e605fcb 54868-5964 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20081119 NDA NDA020616 Physicians Total Care, Inc. MORPHINE SULFATE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-5965_becbc961-a269-4ca9-97a0-0fabad3241e8 54868-5965 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20081121 NDA NDA022122 Physicians Total Care, Inc. DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-5967_11260608-48a3-4881-84d8-f394f1b3b6f6 54868-5967 HUMAN OTC DRUG Eucerin Octinoxate, Zinc Oxide, Octisalate, Ensulizole, Titanium Dioxide LOTION TOPICAL 20081119 OTC MONOGRAPH NOT FINAL part352 Physicians Total Care, Inc. ENSULIZOLE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2; 7.5; 4.5; 2.38; 4.85 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 54868-5968_bac29918-a4b8-4dbc-8620-986e9c6265cc 54868-5968 HUMAN PRESCRIPTION DRUG Travatan Z travoprost SOLUTION OPHTHALMIC 20081209 NDA NDA021994 Physicians Total Care, Inc. TRAVOPROST .04 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 54868-5969_04f573ea-41f5-4891-b474-eb19b2e6caa2 54868-5969 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20081209 NDA NDA021976 Physicians Total Care, Inc. DARUNAVIR ETHANOLATE 400 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] 54868-5971_f534208b-95b9-449a-83bc-5f6dc33b4ea7 54868-5971 HUMAN PRESCRIPTION DRUG Amitiza lubiprostone CAPSULE, GELATIN COATED ORAL 20081216 NDA NDA021908 Physicians Total Care, Inc. LUBIPROSTONE 24 ug/1 Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] 54868-5972_75eebf07-eadb-4b8d-b67c-a5a5780dcfdf 54868-5972 HUMAN PRESCRIPTION DRUG XIFAXAN RIFAXIMIN TABLET ORAL 20081214 NDA NDA021361 Physicians Total Care, Inc. RIFAXIMIN 200 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 54868-5974_b4465a3f-52bf-4b27-a980-dcdf031337be 54868-5974 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20081218 NDA NDA020950 Physicians Total Care, Inc. ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 3; .5 mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 54868-5975_d778c872-757c-4742-842c-58ca85a8a582 54868-5975 HUMAN PRESCRIPTION DRUG Fentanyl Citrate fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 20081219 NDA NDA020747 Physicians Total Care, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-5977_7c4c1776-6fe6-419a-9eb6-3e365693efa3 54868-5977 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20090102 NDA NDA021283 Physicians Total Care, Inc. VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-5978_0b064801-4d1c-4b88-b6cf-7e13611cb2da 54868-5978 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090120 NDA NDA020132 Physicians Total Care, Inc. SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 54868-5979_2674788d-9a0d-4db6-a480-2af6ac2517d4 54868-5979 HUMAN PRESCRIPTION DRUG Nucynta tapentadol hydrochloride TABLET, FILM COATED ORAL 20100319 NDA NDA022304 Physicians Total Care, Inc. TAPENTADOL HYDROCHLORIDE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 54868-5980_cef15d8b-d8c6-491e-9549-695ddc33892b 54868-5980 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 20090126 NDA NDA021029 Physicians Total Care, Inc. TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 54868-5982_16811649-e7c8-4e86-b5e6-e0197ef4d642 54868-5982 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride and Timolol Maleate Dorzolamide Hydrochloride and Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20090204 ANDA ANDA077847 Physicians Total Care, Inc. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] 54868-5983_99fc81a8-679b-46b6-900f-7207a878f6df 54868-5983 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20090622 NDA NDA021990 Physicians Total Care, Inc. AMLODIPINE BESYLATE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-5984_287cfe76-1f00-4498-8d38-61828ba88ad5 54868-5984 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 20090212 NDA NDA019614 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-5985_aae1e3d3-0216-4b36-889c-05871ffa3014 54868-5985 HUMAN PRESCRIPTION DRUG Sancuso granisetron PATCH TRANSDERMAL 20090216 NDA NDA022198 Physicians Total Care, Inc. GRANISETRON 3.1 mg/24h Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 54868-5986_b267a9e3-5e2c-4674-9f42-4df71ae69dcc 54868-5986 HUMAN PRESCRIPTION DRUG Trilipix Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20090219 NDA NDA022224 Physicians Total Care, Inc. FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 54868-5987_36f5e14a-0d01-4aef-b298-4a92c4c2a777 54868-5987 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20090219 ANDA ANDA075410 Physicians Total Care, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 54868-5989_f1be53e3-f694-47b0-9652-f33ae84b1aa1 54868-5989 HUMAN PRESCRIPTION DRUG Alvesco ciclesonide AEROSOL, METERED RESPIRATORY (INHALATION) 20090219 NDA NDA021658 Physicians Total Care, Inc. CICLESONIDE 80 ug/1 54868-5990_f1be53e3-f694-47b0-9652-f33ae84b1aa1 54868-5990 HUMAN PRESCRIPTION DRUG Alvesco ciclesonide AEROSOL, METERED RESPIRATORY (INHALATION) 20090223 NDA NDA021658 Physicians Total Care, Inc. CICLESONIDE 160 ug/1 54868-5991_8a342236-6044-4c69-ae35-48b4e5338fed 54868-5991 HUMAN PRESCRIPTION DRUG EPIDUO adapalene and benzoyl peroxide GEL TOPICAL 20090224 NDA NDA022320 Physicians Total Care, Inc. ADAPALENE; BENZOYL PEROXIDE 1; 25 mg/g; mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-5992_a56cf9f2-99f5-42df-a203-f8245c428ae5 54868-5992 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20090224 ANDA ANDA077511 Physicians Total Care, Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g 54868-5993_a92dc909-acb6-476c-8d3c-3730b809e34e 54868-5993 HUMAN PRESCRIPTION DRUG SULAR Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090224 NDA NDA020356 Physicians Total Care, Inc. NISOLDIPINE 25.5 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 54868-5994_df3a79de-c4f4-485e-bb53-082e9ccb818d 54868-5994 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20090225 ANDA ANDA075868 Physicians Total Care, Inc. FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 54868-5995_e545053a-9ad5-48f1-94c5-8ae86735e581 54868-5995 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20090226 NDA NDA021433 Physicians Total Care, Inc. FLUTICASONE PROPIONATE 44 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-5996_99fc81a8-679b-46b6-900f-7207a878f6df 54868-5996 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20090305 NDA NDA021990 Physicians Total Care, Inc. AMLODIPINE BESYLATE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-5997_99fc81a8-679b-46b6-900f-7207a878f6df 54868-5997 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20090305 NDA NDA021990 Physicians Total Care, Inc. AMLODIPINE BESYLATE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-5998_1197a605-9f66-43f5-84d9-5d580afd8aa4 54868-5998 HUMAN PRESCRIPTION DRUG Kapidex dexlansoprazole CAPSULE, DELAYED RELEASE ORAL 20090305 NDA NDA022287 Physicians Total Care, Inc. DEXLANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 54868-6002_2674788d-9a0d-4db6-a480-2af6ac2517d4 54868-6002 HUMAN PRESCRIPTION DRUG Nucynta tapentadol hydrochloride TABLET, FILM COATED ORAL 20100319 NDA NDA022304 Physicians Total Care, Inc. TAPENTADOL HYDROCHLORIDE 75 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 54868-6003_d5eac7eb-f3db-4562-a97b-f4f2117d361b 54868-6003 HUMAN OTC DRUG Delsym Dextromethorphan SUSPENSION, EXTENDED RELEASE ORAL 20090313 NDA NDA018658 Physicians Total Care, Inc. DEXTROMETHORPHAN 30 mg/5mL 54868-6009_10e3f643-f415-4646-bb59-60ca369f9bb2 54868-6009 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20090320 NDA NDA021977 Physicians Total Care, Inc. LISDEXAMFETAMINE DIMESYLATE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-6010_231bd619-d4f8-4efd-b887-6be6191867b2 54868-6010 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam SOLUTION, CONCENTRATE ORAL 20090331 ANDA ANDA073079 Physicians Total Care, Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-6014_18c9e286-5734-4554-8201-b80a459d5551 54868-6014 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090508 ANDA ANDA090278 Physicians Total Care, Inc TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-6015_18c9e286-5734-4554-8201-b80a459d5551 54868-6015 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20100322 ANDA ANDA090278 Physicians Total Care, Inc TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-6016_18c9e286-5734-4554-8201-b80a459d5551 54868-6016 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090413 ANDA ANDA090278 Physicians Total Care, Inc TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-6017_18c9e286-5734-4554-8201-b80a459d5551 54868-6017 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090506 ANDA ANDA090278 Physicians Total Care, Inc TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-6018_b9d62f7c-cb41-4b19-b488-a88ff08b1baa 54868-6018 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20090415 NDA NDA021742 Physicians Total Care, Inc. NEBIVOLOL HYDROCHLORIDE 10 mg/1 54868-6019_887b9788-8ac1-4e6e-9b2e-8c0e79dcd023 54868-6019 HUMAN PRESCRIPTION DRUG COREGCR CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20090415 NDA NDA022012 Physicians Total Care, Inc. CARVEDILOL PHOSPHATE 10 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 54868-6020_1aa90504-faab-4eb0-9e29-058b6cac81d5 54868-6020 HUMAN PRESCRIPTION DRUG Omnaris ciclesonide SPRAY NASAL 20090415 NDA NDA022004 Physicians Total Care, Inc. CICLESONIDE 50 ug/1 54868-6021_e028add7-0ff7-409f-8e66-cb9e8986d403 54868-6021 HUMAN PRESCRIPTION DRUG Xopenex levalbuterol hydrochloride SOLUTION, CONCENTRATE RESPIRATORY (INHALATION) 20090421 NDA NDA020837 Physicians Total Care, Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/.5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 54868-6022_902dee94-2e89-4ada-96b2-36cc4d1eb34f 54868-6022 HUMAN PRESCRIPTION DRUG AMRIX Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090416 NDA NDA021777 Physicians Total Care, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 54868-6023_0b064801-4d1c-4b88-b6cf-7e13611cb2da 54868-6023 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090416 NDA NDA020132 Physicians Total Care, Inc. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 54868-6024_a5dceee5-5fd9-40e9-824b-022c91017b63 54868-6024 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20100119 NDA NDA022256 Physicians Total Care, Inc. MILNACIPRAN HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-6025_d778c872-757c-4742-842c-58ca85a8a582 54868-6025 HUMAN PRESCRIPTION DRUG Fentanyl Citrate fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 20090424 NDA NDA020747 Physicians Total Care, Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-6026_d778c872-757c-4742-842c-58ca85a8a582 54868-6026 HUMAN PRESCRIPTION DRUG Fentanyl Citrate fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 20090424 NDA NDA020747 Physicians Total Care, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-6027_d778c872-757c-4742-842c-58ca85a8a582 54868-6027 HUMAN PRESCRIPTION DRUG Fentanyl Citrate fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 20090424 NDA NDA020747 Physicians Total Care, Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-6028_6aec4d10-3bac-4afb-bb7f-6a0e23556143 54868-6028 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090504 NDA AUTHORIZED GENERIC NDA021303 Physicians Total Care, Inc. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-6029_6aec4d10-3bac-4afb-bb7f-6a0e23556143 54868-6029 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090504 NDA AUTHORIZED GENERIC NDA021303 Physicians Total Care, Inc. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-6030_bd4c55cb-e75c-4afb-ab21-ea62789e88c9 54868-6030 HUMAN PRESCRIPTION DRUG Femring estradiol acetate RING VAGINAL 20090504 NDA NDA021367 Physicians Total Care, Inc. ESTRADIOL ACETATE .1 mg/24[USP'U] Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-6031_9a1183ca-11db-4b18-9ab4-acb2a7f18e44 54868-6031 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20090506 NDA NDA021995 Physicians Total Care, Inc. SITAGLIPTIN PHOSPHATE 50 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 54868-6033_6aec4d10-3bac-4afb-bb7f-6a0e23556143 54868-6033 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090519 NDA AUTHORIZED GENERIC NDA021303 Physicians Total Care, Inc. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-6034_6aec4d10-3bac-4afb-bb7f-6a0e23556143 54868-6034 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090519 NDA AUTHORIZED GENERIC NDA021303 Physicians Total Care, Inc. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-6035_de09314a-e8c5-4578-937c-307cc649fe84 54868-6035 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS AURICULAR (OTIC) 20090521 ANDA ANDA076616 Physicians Total Care, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54868-6036_94cc0af7-0516-4ef0-8bfe-39f2708ef22e 54868-6036 HUMAN PRESCRIPTION DRUG Azor amlodipine besylate and olmesartan medoxomil TABLET, FILM COATED ORAL 20090602 NDA NDA022100 Physicians Total Care, Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-6037_d778c872-757c-4742-842c-58ca85a8a582 54868-6037 HUMAN PRESCRIPTION DRUG Fentanyl Citrate fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 20090605 NDA NDA020747 Physicians Total Care, Inc. FENTANYL CITRATE 1200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-6038_1598c85f-10aa-4d0c-a631-6ddf886a8a1b 54868-6038 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20090603 ANDA ANDA077056 Physicians Total Care, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 54868-6039_2674788d-9a0d-4db6-a480-2af6ac2517d4 54868-6039 HUMAN PRESCRIPTION DRUG Nucynta tapentadol hydrochloride TABLET, FILM COATED ORAL 20100319 NDA NDA022304 Physicians Total Care, Inc. TAPENTADOL HYDROCHLORIDE 100 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 54868-6041_3a41bc46-8bba-4c61-9299-3108f05a0d4d 54868-6041 HUMAN PRESCRIPTION DRUG Tekturna HCT aliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20090615 NDA NDA022107 Physicians Total Care, Inc. ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-6042_a742bba8-ee3a-4e5b-b670-ea31c4633b3e 54868-6042 HUMAN PRESCRIPTION DRUG Tekturna aliskiren hemifumarate TABLET, FILM COATED ORAL 20090622 NDA NDA021985 Physicians Total Care, Inc. ALISKIREN HEMIFUMARATE 300 mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA] 54868-6043_a5dceee5-5fd9-40e9-824b-022c91017b63 54868-6043 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090622 NDA NDA022256 Physicians Total Care, Inc. MILNACIPRAN HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-6044_edb90de8-4b9c-4e69-b3a2-1bb5eaaff306 54868-6044 HUMAN PRESCRIPTION DRUG Jolessa levonorgestrel and ethinyl estradiol KIT 20090624 NDA NDA021544 Physicians Total Care, Inc. 54868-6045_c460a458-ee62-417c-8e9e-6ce3045b5c40 54868-6045 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20090625 NDA AUTHORIZED GENERIC NDA021134 Physicians Total Care, Inc. NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 54868-6048_3a76a4d0-bd0f-409e-adf0-0cbaae53243c 54868-6048 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20090626 ANDA ANDA079234 Physicians Total Care, Inc. TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 54868-6049_ad1d2297-0516-4581-88af-55f28485fe52 54868-6049 HUMAN PRESCRIPTION DRUG PATANASE olopatadine hydrochloride SPRAY, METERED NASAL 20090713 NDA NDA021861 Physicians Total Care, Inc. OLOPATADINE HYDROCHLORIDE 665 ug/1 Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 54868-6050_be9dfccb-7666-4f44-be3a-32e6acc42ad7 54868-6050 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20091111 NDA NDA020983 Physicians Total Care, Inc. ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 54868-6051_00c1c38b-a6b9-42bd-ab6d-f2e08ac3893f 54868-6051 HUMAN PRESCRIPTION DRUG Proventil HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20090717 NDA NDA020503 Physicians Total Care, Inc. ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 54868-6052_2eb12bd4-ecd4-4917-bb54-bf42702dc6f3 54868-6052 HUMAN PRESCRIPTION DRUG SUMATRIPTAN sumatriptan SPRAY NASAL 20090723 NDA NDA020626 Physicians Total Care, Inc. SUMATRIPTAN 20 mg/100uL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 54868-6056_b54e3b4b-baaf-4df7-a425-21d8caa45b83 54868-6056 HUMAN PRESCRIPTION DRUG Divigel estradiol GEL TOPICAL 20090804 NDA NDA022038 Physicians Total Care, Inc. ESTRADIOL 1 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-6057_0102df63-59b3-4493-ba5b-1ecd914dbc91 54868-6057 HUMAN PRESCRIPTION DRUG Dovonex Calcipotriene SOLUTION TOPICAL 20090812 NDA NDA020611 Physicians Total Care, Inc. CALCIPOTRIENE .05 mg/mL Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 54868-6061_02953299-f03e-4305-9b78-8590f2ad4a46 54868-6061 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20090826 ANDA ANDA077256 Physicians Total Care, Inc. TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 54868-6062_61d8c50d-47a7-409d-a3bb-b74d2a745487 54868-6062 HUMAN PRESCRIPTION DRUG BENZACLIN clindamycin phosphate and benzoyl peroxide GEL TOPICAL 20090827 NDA NDA050756 Physicians Total Care, Inc. BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 50; 10 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 54868-6064_5697e989-d676-4d13-81dc-b7ffe7be4f1f 54868-6064 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SOLUTION TOPICAL 20090904 ANDA ANDA078079 Physicians Total Care, Inc. CICLOPIROX 80 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 54868-6065_3bbca54f-08ae-4ef7-8a8c-75a204f4df8a 54868-6065 HUMAN PRESCRIPTION DRUG Eplerenone Eplerenone TABLET ORAL 20090914 ANDA ANDA078510 Physicians Total Care, Inc. EPLERENONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 54868-6066_4896f77d-3d97-4ffa-ad89-e8bd4cf20feb 54868-6066 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20090924 ANDA ANDA076685 Physicians Total Care, Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-6067_1adb5942-7330-48c9-add5-a0b321ce860b 54868-6067 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE PELLETS ORAL 20090929 NDA NDA020725 Physicians Total Care, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 60000; 12000; 38000 [USP'U]/1; [USP'U]/1; [USP'U]/1 54868-6069_b1023888-d89d-4c9f-9c22-c1722cdc204c 54868-6069 HUMAN PRESCRIPTION DRUG Actonel risedronate sodium TABLET, FILM COATED ORAL 20091005 NDA NDA020835 Physicians Total Care, Inc. RISEDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 54868-6070_7cccdc96-0f15-4755-9d18-9d74f55a815c 54868-6070 HUMAN PRESCRIPTION DRUG Exelon rivastigmine PATCH, EXTENDED RELEASE TRANSDERMAL 20091007 NDA NDA022083 Physicians Total Care, Inc. RIVASTIGMINE 4.6 mg/24[USP'U] Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 54868-6071_cdd1637a-0bda-4407-a4dd-4eccef86151d 54868-6071 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20091013 ANDA ANDA040350 Physicians Total Care, Inc. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 54868-6072_e96fff12-7b42-4b58-8bd9-7b96eb2b120c 54868-6072 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20091015 ANDA ANDA076941 Physicians Total Care, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 54868-6073_f10bdd5f-6af1-4f57-ac08-c5627263ac51 54868-6073 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20091016 ANDA ANDA077802 Physicians Total Care, Inc. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-6074_9f42c78b-8bd4-413e-9e48-276ef6926eb2 54868-6074 HUMAN PRESCRIPTION DRUG Carbamazepine ER Carbamazepine TABLET, EXTENDED RELEASE ORAL 20091016 NDA NDA020234 Physicians Total Care, Inc. CARBAMAZEPINE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 54868-6075_d4bd0a6d-9832-4d55-b129-5d2134eeb6c4 54868-6075 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20091015 ANDA ANDA078858 Physicians Total Care, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-6076_d4bd0a6d-9832-4d55-b129-5d2134eeb6c4 54868-6076 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20091015 ANDA ANDA078858 Physicians Total Care, Inc. LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-6077_cca8b765-71be-4b37-8c7c-d6447a21e00a 54868-6077 HUMAN PRESCRIPTION DRUG Vimpat lacosamide TABLET, FILM COATED ORAL 20091022 NDA NDA022253 Physicians Total Care, Inc. LACOSAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV 54868-6078_803d538c-3eeb-4c67-97a1-40da1861fc84 54868-6078 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20091209 ANDA ANDA076388 Physicians Total Care, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 54868-6082_c031d46a-1f80-4600-ab2e-ff0b6e267e2a 54868-6082 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 20091028 ANDA ANDA079088 Physicians Total Care, Inc RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 54868-6083_88cfbec5-a553-46d5-bbfc-2c3a29b7f171 54868-6083 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 20091030 NDA NDA021087 Physicians Total Care, Inc. OSELTAMIVIR PHOSPHATE 45 mg/1 Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] 54868-6085_36f5e14a-0d01-4aef-b298-4a92c4c2a777 54868-6085 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20091106 ANDA ANDA075410 Physicians Total Care, Inc. OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 54868-6086_c6479658-c5ee-4c63-9101-6bededba3cd2 54868-6086 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091117 ANDA ANDA077255 Physicians Total Care, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 54868-6087_e1c35407-b232-4a2d-ae2d-ff942ef35ce0 54868-6087 HUMAN PRESCRIPTION DRUG FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100107 NDA NDA020786 Physicians Total Care, Inc. FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] CV 54868-6088_ec4d96db-d1ec-4654-91f8-15324a5a104c 54868-6088 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091120 ANDA ANDA078445 Physicians Total Care, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 54868-6089_60dc7288-1d4d-4cb4-9faf-aecf3b9ae870 54868-6089 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100611 ANDA ANDA077135 Physicians Total Care, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 54868-6090_60dc7288-1d4d-4cb4-9faf-aecf3b9ae870 54868-6090 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20091203 ANDA ANDA077135 Physicians Total Care, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 54868-6091_276e3274-fac6-4ead-ad69-89d65bb11fba 54868-6091 HUMAN PRESCRIPTION DRUG Taclonex Scalp calcipotriene and betamethasone dipropionate SUSPENSION TOPICAL 20091210 NDA NDA022185 Physicians Total Care, Inc. BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE .643; 50 mg/g; ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-6093_e3ca07e3-30a1-4d8a-85b2-0b012c9d9080 54868-6093 HUMAN PRESCRIPTION DRUG REQUIP XL ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091218 NDA NDA022008 Physicians Total Care, Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 54868-6094_cac38eb9-dc7f-4ce6-99b6-c65d10caf2f8 54868-6094 HUMAN PRESCRIPTION DRUG Brimonidine Tartrate brimonidine tartrate SOLUTION OPHTHALMIC 20091222 NDA NDA021764 Physicians Total Care, Inc. BRIMONIDINE TARTRATE 1.5 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 54868-6096_82e68d4e-ed88-4842-a61b-4987c4119d69 54868-6096 HUMAN PRESCRIPTION DRUG Altabax retapamulin OINTMENT TOPICAL 20100107 NDA NDA022055 Physicians Total Care, Inc. RETAPAMULIN 10 mg/g pleuromutilin [Chemical/Ingredient],Pleuromutilin Antibacterial [EPC] 54868-6097_11c40932-8c8f-4a48-8b1f-c0fa4c7dbaa7 54868-6097 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20100114 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 54868-6099_f9124873-60f0-4947-a483-f4629b8077e2 54868-6099 HUMAN PRESCRIPTION DRUG DEXAMETHASONE Sodium Phosphate Dexamethasone INJECTION INTRAMUSCULAR; INTRAVENOUS 20100115 ANDA ANDA081126 Physicians Total Care, Inc. DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-6100_7c74ca49-b7e0-4b27-91e7-132a2359a5dc 54868-6100 HUMAN PRESCRIPTION DRUG Loestrin 24 Fe norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20100128 NDA NDA021871 Physicians Total Care, Inc. 54868-6102_3a7a371f-b5ed-4289-9462-548cb57122a3 54868-6102 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20100407 ANDA ANDA040445 Physicians Total Care, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 54868-6103_3a41bc46-8bba-4c61-9299-3108f05a0d4d 54868-6103 HUMAN PRESCRIPTION DRUG Tekturna HCT aliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20100413 NDA NDA022107 Physicians Total Care, Inc. ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-6104_fbd6b677-f2fb-40ca-badb-81e6bac27d3f 54868-6104 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100413 ANDA ANDA076958 Physicians Total Care, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-6105_db793c72-3826-4b5c-a32a-952cd3d85cd9 54868-6105 HUMAN OTC DRUG Lamisil Terbinafine Hydrochloride SPRAY TOPICAL 20100413 NDA NDA021124 Physicians Total Care, Inc. TERBINAFINE HYDROCHLORIDE 1.25 mL/125mL 54868-6106_5d1f4a78-f738-4bff-8713-6bc897e4fb67 54868-6106 HUMAN OTC DRUG Mucinex DM Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20100419 NDA NDA021620 Physicians Total Care, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 54868-6107_fbd6b677-f2fb-40ca-badb-81e6bac27d3f 54868-6107 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100413 ANDA ANDA076958 Physicians Total Care, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-6108_587513fd-ac8b-4ee3-955d-9415b299b5d4 54868-6108 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100419 ANDA ANDA077157 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-6109_587513fd-ac8b-4ee3-955d-9415b299b5d4 54868-6109 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100419 ANDA ANDA077157 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-6110_587513fd-ac8b-4ee3-955d-9415b299b5d4 54868-6110 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100419 ANDA ANDA077157 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-6111_485c2855-f3f6-42cc-81cd-669d454366d7 54868-6111 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100420 ANDA ANDA077724 Physicians Total Care, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 54868-6112_24522f17-ad4c-4957-87ec-5a66cffb6e24 54868-6112 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20100420 ANDA ANDA076615 Physicians Total Care, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54868-6114_bd9828d4-5f5f-4afa-bf84-1a2d299d5cab 54868-6114 HUMAN PRESCRIPTION DRUG Differin adapalene LOTION TOPICAL 20100427 NDA NDA022502 Physicians Total Care, Inc. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-6115_8b3759e9-e20f-433d-acdb-173863e2b2ae 54868-6115 HUMAN PRESCRIPTION DRUG Xyzal levocetirizine dihydrochloride SOLUTION ORAL 20100427 NDA NDA022157 Physicians Total Care, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 54868-6116_3d4b67bb-e159-4b4f-aa17-624515cd639f 54868-6116 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole POWDER, FOR SUSPENSION ORAL 20100427 NDA AUTHORIZED GENERIC NDA020090 Physicians Total Care, Inc. FLUCONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 54868-6117_fbd6b677-f2fb-40ca-badb-81e6bac27d3f 54868-6117 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100427 ANDA ANDA076958 Physicians Total Care, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-6118_3771fabc-7d2e-47f6-afe7-583101ac2663 54868-6118 HUMAN PRESCRIPTION DRUG Fenoglide fenofibrate TABLET ORAL 20100428 NDA NDA022118 Physicians Total Care, Inc. FENOFIBRATE 120 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 54868-6121_485c2855-f3f6-42cc-81cd-669d454366d7 54868-6121 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100503 ANDA ANDA077724 Physicians Total Care, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 54868-6122_8f85671a-7f36-42ac-b237-feef70a67864 54868-6122 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate OINTMENT OPHTHALMIC 20100504 ANDA ANDA062166 Physicians Total Care, Inc. BACITRACIN ZINC; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 10; 3.5; 10000 [USP'U]/g; mg/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-6123_8bc4df4b-1f3b-46a4-a17a-011d24b1e2b9 54868-6123 HUMAN PRESCRIPTION DRUG Exforge HCT amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20100514 NDA NDA022314 Physicians Total Care, Inc. AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10; 25; 320 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 54868-6124_cf206f2d-793d-4301-a75a-ed2b1d90ba4c 54868-6124 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100517 ANDA ANDA078306 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 200 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 54868-6125_5d79fc6e-7e80-4b19-863d-87e0ae57cfe2 54868-6125 HUMAN OTC DRUG Childrens Mucinex Cough Guaifenesin and Dextromethorphan Hydrobromide SOLUTION ORAL 20100519 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 54868-6126_a706be2f-5593-485d-8791-b7aa923e2dfd 54868-6126 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate gentamicin sulfate OINTMENT TOPICAL 20100602 ANDA ANDA062533 Physicians Total Care, Inc. GENTAMICIN SULFATE 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 54868-6127_5d36e1b8-3f6e-4ff2-829b-17f6f69b6250 54868-6127 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100611 NDA NDA022104 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-6128_d35cb135-1059-4acd-8c5b-86f33f4a6200 54868-6128 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101117 ANDA ANDA078783 Physicians Total Care, Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 54868-6129_f10bdd5f-6af1-4f57-ac08-c5627263ac51 54868-6129 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20100623 ANDA ANDA077802 Physicians Total Care, Inc. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-6130_abee0b23-ecb8-49a1-847e-6bb088e2bfea 54868-6130 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100701 ANDA ANDA079220 Physicians Total Care, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 54868-6131_32c5651e-9e68-4bd6-a694-a809cd7c181f 54868-6131 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride azelastine hydrochloride SPRAY, METERED NASAL 20110628 ANDA ANDA077954 Physicians Total Care, Inc. AZELASTINE HYDROCHLORIDE 137 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 54868-6132_1d8895b4-2882-4a9e-95fb-646e8d8d1367 54868-6132 HUMAN PRESCRIPTION DRUG Adapalene Adapalene GEL TOPICAL 20100709 ANDA ANDA090962 Physicians Total Care, Inc. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-6133_2ba7e0fa-a7ca-4cc9-a6e8-5929d5dfe73c 54868-6133 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20100809 ANDA ANDA076932 Physicians Total Care, Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 54868-6136_ab2d1f67-4b2a-4b51-ba4d-7a01b8577549 54868-6136 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride FOR SUSPENSION ORAL 20100722 NDA NDA022362 Physicians Total Care, Inc. COLESEVELAM HYDROCHLORIDE 3.75 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 54868-6137_c2df194f-9b49-423d-83eb-ac96ab972079 54868-6137 HUMAN PRESCRIPTION DRUG Balsalazide Disodium Balsalazide Disodium CAPSULE ORAL 20100818 ANDA ANDA077806 Physicians Total Care, Inc. BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 54868-6138_e8b2ce9c-39b3-4a1b-97fd-c95233a4d6bb 54868-6138 HUMAN PRESCRIPTION DRUG PEG-3350 and Electrolytes PEG-3350 and Electrolytes POWDER, FOR SOLUTION ORAL 20100820 NDA AUTHORIZED GENERIC NDA019011 Physicians Total Care, Inc. POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 236; 2.97; 6.74; 5.86; 22.74 g/2L; g/2L; g/2L; g/2L; g/2L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 54868-6139_001447cf-1dad-47bf-be69-f41d581dd21d 54868-6139 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20101108 ANDA ANDA076565 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-6140_001447cf-1dad-47bf-be69-f41d581dd21d 54868-6140 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100802 ANDA ANDA076565 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-6141_001447cf-1dad-47bf-be69-f41d581dd21d 54868-6141 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20101108 ANDA ANDA076565 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-6145_988e5b01-81d6-4f88-befc-895e755dfb77 54868-6145 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate rivastigmine tartrate CAPSULE ORAL 20100915 ANDA ANDA077131 Physicians Total Care, Inc. RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 54868-6146_7af60e76-41ca-4324-8f44-c6cc00fdd694 54868-6146 HUMAN PRESCRIPTION DRUG Norditropin somatropin INJECTION, SOLUTION SUBCUTANEOUS 20100810 NDA NDA021148 Physicians Total Care, Inc. SOMATROPIN 5 mg/1.5mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] 54868-6147_5184c8dc-937f-401c-b359-93717cd37476 54868-6147 HUMAN PRESCRIPTION DRUG Canasa mesalamine SUPPOSITORY RECTAL 20100818 NDA NDA021252 Physicians Total Care, Inc. MESALAMINE 1000 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 54868-6148_5be0bfc5-80d8-4f8a-afe3-eafa62312d38 54868-6148 HUMAN PRESCRIPTION DRUG Adapalene Adapalene CREAM TOPICAL 20101001 ANDA ANDA090824 Physicians Total Caer, Inc. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-6150_d0294c21-ce61-46a3-a62e-11cfed40c8d9 54868-6150 HUMAN PRESCRIPTION DRUG APRISO mesalamine CAPSULE, EXTENDED RELEASE ORAL 20100818 NDA NDA022301 Physicians Total Care, Inc. MESALAMINE 375 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 54868-6151_d6005cba-5d7d-4540-b1f2-5715e0870693 54868-6151 HUMAN PRESCRIPTION DRUG Pylera Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride (140 mg/125 mg/125 mg) CAPSULE ORAL 20100818 NDA NDA050786 Physicians Total Care, Inc. BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE 140; 125; 125 mg/1; mg/1; mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient],Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 54868-6152_f517d5f1-7d2e-4231-822d-e28898925664 54868-6152 HUMAN PRESCRIPTION DRUG Dexilant dexlansoprazole CAPSULE, DELAYED RELEASE ORAL 20100819 NDA NDA022287 Physicians Total Care, Inc. DEXLANSOPRAZOLE 60 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 54868-6153_f534208b-95b9-449a-83bc-5f6dc33b4ea7 54868-6153 HUMAN PRESCRIPTION DRUG Amitiza lubiprostone CAPSULE, GELATIN COATED ORAL 20100819 NDA NDA021908 Physicians Total Care, Inc. LUBIPROSTONE 8 ug/1 Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] 54868-6154_75eebf07-eadb-4b8d-b67c-a5a5780dcfdf 54868-6154 HUMAN PRESCRIPTION DRUG XIFAXAN RIFAXIMIN TABLET ORAL 20100819 NDA NDA022554 Physicians Total Care, Inc. RIFAXIMIN 550 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 54868-6155_c7ba3463-0eee-4b4f-a4e6-369711c2f6be 54868-6155 HUMAN PRESCRIPTION DRUG Tindamax tinidazole TABLET, FILM COATED ORAL 20100823 NDA NDA021618 Physicians Total Care, Inc. TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 54868-6156_16d63980-82e0-4bdf-a98b-4bb6640ad5a5 54868-6156 HUMAN PRESCRIPTION DRUG Toviaz fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100823 NDA NDA022030 Physicians Total Care, Inc. FESOTERODINE FUMARATE 4 mg/1 54868-6157_978cf43f-09f5-45f1-84e4-27caa1fda33a 54868-6157 HUMAN PRESCRIPTION DRUG Evamist estradiol SPRAY, METERED TRANSDERMAL 20100823 NDA NDA022014 Physicians Total Care, Inc. ESTRADIOL 1.53 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-6159_485c2855-f3f6-42cc-81cd-669d454366d7 54868-6159 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100823 ANDA ANDA077724 Physicians Total Care, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 54868-6160_8d38d308-d218-4f4e-b7bf-e29acb3a8c56 54868-6160 HUMAN PRESCRIPTION DRUG Terconazole terconazole CREAM VAGINAL 20100824 ANDA ANDA076712 Physicians Total Care, Inc. TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 54868-6161_65ae4b2a-4882-412d-8aab-1f4fafc496ff 54868-6161 HUMAN PRESCRIPTION DRUG FEMCON Fe norethindrone and ethinyl estradiol, and ferrous fumarate KIT 20100921 NDA NDA021490 Physicians Total Care, Inc. 54868-6162_e5c8e9c5-421d-4db2-adc4-01bbd85aeb43 54868-6162 HUMAN PRESCRIPTION DRUG GIANVI drospirenone and ethinyl estradiol KIT 20101021 ANDA ANDA078515 Physicians Total Care, Inc. 54868-6163_4d771c59-9794-43b9-bef4-5fdf96c2fe80 54868-6163 HUMAN PRESCRIPTION DRUG ENJUVIA synthetic conjugated estrogens, B TABLET ORAL 20100903 NDA NDA021443 Physicians Total Care, Inc. ESTROGENS, CONJUGATED SYNTHETIC B .625 mg/1 54868-6164_4d771c59-9794-43b9-bef4-5fdf96c2fe80 54868-6164 HUMAN PRESCRIPTION DRUG ENJUVIA synthetic conjugated estrogens, B TABLET ORAL 20100903 NDA NDA021443 Physicians Total Care, Inc. ESTROGENS, CONJUGATED SYNTHETIC B .3 mg/1 54868-6165_4d771c59-9794-43b9-bef4-5fdf96c2fe80 54868-6165 HUMAN PRESCRIPTION DRUG ENJUVIA synthetic conjugated estrogens, B TABLET ORAL 20100903 NDA NDA021443 Physicians Total Care, Inc. ESTROGENS, CONJUGATED SYNTHETIC B .9 mg/1 54868-6167_af99b509-0cf2-40cb-9198-40414a82ca46 54868-6167 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20100908 ANDA ANDA078230 Physicians Total Care, Inc. ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 54868-6168_8f31bccd-974a-40a1-aeba-578cd42d2700 54868-6168 HUMAN PRESCRIPTION DRUG Veramyst fluticasone furoate SPRAY, METERED NASAL 20100907 NDA NDA022051 Physicians Total Care, Inc. FLUTICASONE FUROATE 27.5 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-6169_85d265f2-9b74-42d3-9b33-c34573be8c1e 54868-6169 HUMAN PRESCRIPTION DRUG Simcor simvastatin and niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100914 NDA NDA022078 Physicians Total Care, Inc. NIACIN; SIMVASTATIN 1000; 40 mg/1; mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 54868-6170_fad3dfbe-5257-4305-ac6e-d7a6a4befae8 54868-6170 HUMAN PRESCRIPTION DRUG Leflunomide leflunomide TABLET, FILM COATED ORAL 20100917 ANDA ANDA077087 Physicians Total Care, Inc. LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] 54868-6171_b87eb0de-eb1d-4ece-833b-b4f2c9c0210f 54868-6171 HUMAN PRESCRIPTION DRUG GELNIQUE oxybutynin chloride GEL TRANSDERMAL 20100915 NDA NDA022204 Physicians Total Care, Inc. OXYBUTYNIN CHLORIDE 100 mg/g Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54868-6173_9a9ef99a-a794-43c0-ba3e-169752985a92 54868-6173 HUMAN PRESCRIPTION DRUG RAPAFLO silodosin CAPSULE ORAL 20100915 NDA NDA022206 Physicians Total Care, Inc. SILODOSIN 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 54868-6175_16d63980-82e0-4bdf-a98b-4bb6640ad5a5 54868-6175 HUMAN PRESCRIPTION DRUG Toviaz fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100915 NDA NDA022030 Physicians Total Care, Inc. FESOTERODINE FUMARATE 8 mg/1 54868-6176_09893986-19e0-4364-93ba-5fbc7e7d3eed 54868-6176 HUMAN PRESCRIPTION DRUG UROCIT-K potassium citrate TABLET, EXTENDED RELEASE ORAL 20100915 NDA NDA019071 Physicians Total Care, Inc. POTASSIUM CITRATE 15 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 54868-6178_a097b2cb-9177-4e62-a4b6-cd40fefe6c83 54868-6178 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101025 ANDA ANDA077873 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-6179_aa69b361-6057-4a69-91b3-55681cb482b4 54868-6179 HUMAN PRESCRIPTION DRUG Imiquimod imiquimod CREAM TOPICAL 20100922 ANDA ANDA078548 Physicians Total Care, Inc. IMIQUIMOD 50 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 54868-6181_b847a611-8ba0-43ec-b75c-09aeee36c2ee 54868-6181 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole GEL TOPICAL 20100924 ANDA ANDA077819 Physicians Total Care, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 54868-6182_ad9ebd92-2d74-4cac-aea3-3c33d3a9f116 54868-6182 HUMAN PRESCRIPTION DRUG Vagifem estradiol TABLET, FILM COATED VAGINAL 20100924 NDA NDA020908 Physicians Total Care, Inc. ESTRADIOL 10 ug/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-6183_3133bc7c-85c8-425b-990c-91f7b251bd71 54868-6183 HUMAN PRESCRIPTION DRUG Natazia estradiol valerate and estradiol valerate/dienogest KIT 20100929 NDA NDA022252 Physicians Total Care, Inc. 54868-6184_381ff0dc-5960-485c-bc92-86e717e39c04 54868-6184 HUMAN PRESCRIPTION DRUG Angeliq drospirenone and estradiol TABLET, FILM COATED ORAL 20100929 NDA NDA021355 Physicians Total Care, Inc. DROSPIRENONE; ESTRADIOL .5; 1 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 54868-6185_3bb13bf6-83da-41af-afb5-46ccd13314a3 54868-6185 HUMAN PRESCRIPTION DRUG Claravis isotretinoin CAPSULE ORAL 20131004 ANDA ANDA076135 Physicians Total Care, Inc. ISOTRETINOIN 30 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-6186_7a41cfe2-4505-4db2-91e7-51493a47f497 54868-6186 HUMAN OTC DRUG Infant Glycerin Laxative Glycerin SUPPOSITORY RECTAL 20101027 OTC MONOGRAPH FINAL part334 Physicians Total Care, Inc. GLYCERIN 1.3 g/1 54868-6189_e5d3b2c1-fd39-4369-bce0-4db9ea8b3183 54868-6189 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101102 ANDA ANDA078179 Physicians Total Care, Inc. ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 54868-6190_c2821be4-8191-4ddf-9235-d660b25a3590 54868-6190 HUMAN PRESCRIPTION DRUG Doxycycline Monohydrate Doxycycline CAPSULE ORAL 20101022 NDA AUTHORIZED GENERIC NDA050641 Physicians Total Care, Inc. DOXYCYCLINE 100 mg/1 54868-6192_6aec4d10-3bac-4afb-bb7f-6a0e23556143 54868-6192 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20101101 NDA AUTHORIZED GENERIC NDA021303 Physicians Total Care, Inc. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-6193_d6d6402a-3913-4adf-b6e6-f4676533a3a5 54868-6193 HUMAN PRESCRIPTION DRUG Micardis TELMISARTAN TABLET ORAL 20101102 NDA NDA020850 Physicians Total Care, Inc. TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-6194_3a41bc46-8bba-4c61-9299-3108f05a0d4d 54868-6194 HUMAN PRESCRIPTION DRUG Tekturna HCT aliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20101103 NDA NDA022107 Physicians Total Care, Inc. ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE 300; 25 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 54868-6195_691a547f-2287-494d-854f-a3f65a2b971f 54868-6195 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION OPHTHALMIC 20101103 ANDA ANDA090017 Physicians Total Care, Inc. KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-6196_239fdd51-8d4c-4ffd-9aa4-bcf804eac4a3 54868-6196 HUMAN PRESCRIPTION DRUG Hydrocodone Polistirex and Chlorpheniramine Polistirex Hydrocodone Polistirex and Chlorpheniramine Polistirex SUSPENSION ORAL 20101103 ANDA ANDA091632 Physicians Total Care, Inc. CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE 8; 10 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CIII 54868-6197_c6479658-c5ee-4c63-9101-6bededba3cd2 54868-6197 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20101117 ANDA ANDA077255 Physicians Total Care, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 54868-6198_87ea2799-31b0-4369-a95c-8fd1b3da148a 54868-6198 HUMAN PRESCRIPTION DRUG Podofilox Podofilox SOLUTION TOPICAL 20101112 NDA AUTHORIZED GENERIC NDA019795 Physicians Total Care, Inc. PODOFILOX 5 mg/mL Decreased Mitosis [PE] 54868-6201_c031d46a-1f80-4600-ab2e-ff0b6e267e2a 54868-6201 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 20101115 ANDA ANDA079088 Physicians Total Care, Inc RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 54868-6203_bd95b77f-57ef-45bf-826b-ed657c0df2c8 54868-6203 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/Macrocrystals Nitrofurantoin Monohydrate and Nitrofurantoin, macrocrystalline CAPSULE ORAL 20110106 ANDA ANDA076648 Physicians Total Care, Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 54868-6204_658613fc-a080-468d-b588-ce32ece3171b 54868-6204 HUMAN PRESCRIPTION DRUG Vanos fluocinonide CREAM TOPICAL 20101130 NDA NDA021758 Physicians Total Care, Inc. FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-6205_bf2e8109-f748-4110-bdfb-23e4c43acdec 54868-6205 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20101130 ANDA ANDA078730 Physicians Total Care, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 54868-6206_9eddc1b7-4b71-4145-b097-2b1cb1abee9e 54868-6206 HUMAN PRESCRIPTION DRUG Azilect rasagiline mesylate TABLET ORAL 20101203 NDA NDA021641 Physicians Total Care, Inc. RASAGILINE MESYLATE 1 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] 54868-6207_9dffbd3e-8046-45ac-b56e-538cde87b59b 54868-6207 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20101207 ANDA ANDA076786 Physicians Total Care, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 54868-6208_9dffbd3e-8046-45ac-b56e-538cde87b59b 54868-6208 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20101227 ANDA ANDA076786 Physicians Total Care, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 54868-6209_2405423b-da88-4bfb-a366-1f19ecaf341a 54868-6209 HUMAN OTC DRUG Docusate Sodium Docusate Sodium LIQUID ORAL 20101207 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. DOCUSATE SODIUM 50 mg/5mL 54868-6210_110b472e-8a7b-48e1-9d79-d02066dda224 54868-6210 HUMAN PRESCRIPTION DRUG Lutera Levonorgestrel and Ethinyl Estradiol KIT 20101213 ANDA ANDA076625 Physicians Total Care, Inc. 54868-6211_b02b798f-01b7-491e-8802-11057828e6f6 54868-6211 HUMAN PRESCRIPTION DRUG Menest Estrogens, esterified TABLET ORAL 20101209 ANDA ANDA084951 Physicians Total Care, Inc. ESTROGENS, ESTERIFIED .3 mg/1 54868-6212_b02b798f-01b7-491e-8802-11057828e6f6 54868-6212 HUMAN PRESCRIPTION DRUG Menest Estrogens, esterified TABLET ORAL 20101216 ANDA ANDA084950 Physicians Total Care, Inc. ESTROGENS, ESTERIFIED 1.25 mg/1 54868-6213_2da371ca-e885-413a-849b-cc6a10ac6219 54868-6213 HUMAN PRESCRIPTION DRUG Microgestin Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20101213 ANDA ANDA075647 Physicians Total Care, Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE .02; 1 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-6214_f72892dc-01cf-4e66-a841-aae20aa65500 54868-6214 HUMAN PRESCRIPTION DRUG Clonidine Clonidine PATCH TRANSDERMAL 20101214 ANDA ANDA076157 Physicians Total Care, Inc. CLONIDINE .2 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54868-6215_035d775b-7280-44af-be40-223e3e66d7fc 54868-6215 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101216 NDA NDA021774 Physicians Total Care, Inc. ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 54868-6219_7de0ea4c-1210-47b8-96c3-c6fa763d1c1d 54868-6219 HUMAN PRESCRIPTION DRUG Ethambutol Ethambutol hydrochloride TABLET, FILM COATED ORAL 20101220 ANDA ANDA075095 Physicians Total Care, Inc. ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] 54868-6220_603d0174-6801-4fa0-bca9-23cd3aa86dfe 54868-6220 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20101222 ANDA ANDA077401 Physicians Total Care, Inc. MOMETASONE FUROATE 1 mg/g 54868-6221_afc7725d-445d-42bf-b41c-f4614121710b 54868-6221 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20101229 ANDA ANDA077634 Physicians Total Care, Inc. ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-6222_00904221-c0c7-49bd-b00a-8689a2a5a386 54868-6222 HUMAN PRESCRIPTION DRUG Pataday olopatadine hydrochloride SOLUTION/ DROPS OPHTHALMIC 20110103 NDA NDA021545 Physicians Total Care, Inc. OLOPATADINE HYDROCHLORIDE 2 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 54868-6223_22703ed4-6d7f-4caa-9bac-399719e8e447 54868-6223 HUMAN OTC DRUG Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20110113 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 54868-6224_64554bc4-3743-440f-ac7d-ee3e65413c99 54868-6224 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20110114 ANDA ANDA077171 Physicians Total Care, Inc. CLONAZEPAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 54868-6225_bd548d56-474a-4581-8427-f866b4e7c2db 54868-6225 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SUSPENSION TOPICAL 20110119 ANDA ANDA077015 Physicians Total Care, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 54868-6227_6aec4d10-3bac-4afb-bb7f-6a0e23556143 54868-6227 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20110303 NDA AUTHORIZED GENERIC NDA021303 Physicians Total Care, Inc. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-6231_929a6a1f-8668-425d-aec4-15793be80ea7 54868-6231 HUMAN PRESCRIPTION DRUG Lantus insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20110207 NDA NDA021081 Physicians Total Care, Inc. INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 54868-6232_fedee476-b4b4-47d3-93d4-8d9665ee3c64 54868-6232 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED ORAL 20110210 ANDA ANDA065110 Physicians Total Care, Inc. CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 54868-6233_3fb77464-a314-4880-8da2-fec6bb912db3 54868-6233 HUMAN OTC DRUG Cold Head Congestion Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20110216 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 54868-6234_79201e83-d9e6-42a7-98b6-bd51edbdc233 54868-6234 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110302 NDA NDA021259 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-6237_485c2855-f3f6-42cc-81cd-669d454366d7 54868-6237 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20110408 ANDA ANDA077724 Physicians Total Care, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 54868-6238_315dd1fe-0930-43f1-b574-a5f5e7f6f7a3 54868-6238 HUMAN PRESCRIPTION DRUG Effient Prasugrel hydrochloride TABLET, FILM COATED ORAL 20110315 NDA NDA022307 Physicians Total Care, Inc. PRASUGREL HYDROCHLORIDE 10 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 54868-6239_184f97d8-240b-46c5-ba36-c8b51aa988a3 54868-6239 HUMAN PRESCRIPTION DRUG EPINEPHRINE epinephrine INJECTION SUBCUTANEOUS 20110418 NDA NDA020800 Physicians Total Care, Inc. EPINEPHRINE .3 mg/1 Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 54868-6241_67e1dbc2-7747-4971-8916-e0bca4f7293f 54868-6241 HUMAN OTC DRUG ENTEX LQ guaifenesin and phenylephrine hydrochloride LIQUID ORAL 20110401 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 100; 10 mg/5mL; mg/5mL 54868-6243_c031d46a-1f80-4600-ab2e-ff0b6e267e2a 54868-6243 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 20110408 ANDA ANDA079088 Physicians Total Care, Inc RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 54868-6246_dc77182b-f12d-4f92-a0c1-06cd63d6a68b 54868-6246 HUMAN PRESCRIPTION DRUG VUSION miconazole nitrate, zinc oxide, white petrolatum OINTMENT TOPICAL 20110418 NDA NDA021026 Physicians Total Care, Inc. MICONAZOLE NITRATE; PETROLATUM; ZINC OXIDE 2.5; 813.5; 150 mg/g; mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 54868-6247_ea19bd36-7cb9-4836-b1f3-a2b6c852906e 54868-6247 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20110422 ANDA ANDA078627 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-6248_0a8038cc-83a1-4e1d-8773-2c4958dd0183 54868-6248 HUMAN PRESCRIPTION DRUG HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM TOPICAL 20110425 NDA NDA018514 Physicians Total Care, Inc. HYDROCORTISONE BUTYRATE 1 mg/g 54868-6250_94cc0af7-0516-4ef0-8bfe-39f2708ef22e 54868-6250 HUMAN PRESCRIPTION DRUG Azor amlodipine besylate and olmesartan medoxomil TABLET, FILM COATED ORAL 20110426 NDA NDA022100 Physicians Total Care, Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 54868-6251_4b31262e-a660-4648-ab54-45e8d18c6c5d 54868-6251 HUMAN PRESCRIPTION DRUG JINTELI norethindrone acetate and ethinyl estradiol TABLET ORAL 20110426 ANDA ANDA076221 Physicians Total Care, Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 5; 1 ug/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-6252_effc4ce8-4df7-4c94-86fd-a457323fba9b 54868-6252 HUMAN PRESCRIPTION DRUG LETROZOLE letrozole TABLET, FILM COATED ORAL 20110504 ANDA ANDA078190 Physicians Total Care, Inc. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 54868-6253_96b4ed40-9853-4ac2-8b3a-4548355d1c40 54868-6253 HUMAN PRESCRIPTION DRUG NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN neomycin sulfate, polymyxin b sulfate and gramicidin SOLUTION/ DROPS OPHTHALMIC 20110426 ANDA ANDA064047 Physicians Total Care, Inc. GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE .025; 1.75; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 54868-6254_f76f06af-da9c-4603-ae19-a5620e776c2f 54868-6254 HUMAN PRESCRIPTION DRUG Latanoprost Latanoprost SOLUTION/ DROPS OPHTHALMIC 20110621 ANDA ANDA201006 Physicians Total Care, Inc. LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 54868-6255_57e523a5-55be-4d38-a5e0-0141447863bf 54868-6255 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20110503 ANDA ANDA077463 Physicians Total Care, Inc. NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 54868-6256_6429e27f-6b2a-477f-8f53-56fa6e1129d7 54868-6256 HUMAN PRESCRIPTION DRUG Colcrys Colchicine TABLET, FILM COATED ORAL 20111019 NDA NDA022352 Physicians Total Care, Inc. COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 54868-6259_36f1f619-eff7-4e7b-a0d7-24c2a3db8a7e 54868-6259 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION PARENTERAL 20110505 ANDA ANDA072076 Physicians Total Care, Inc. NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 54868-6260_f72892dc-01cf-4e66-a841-aae20aa65500 54868-6260 HUMAN PRESCRIPTION DRUG Clonidine Clonidine PATCH TRANSDERMAL 20110510 ANDA ANDA076157 Physicians Total Care, Inc. CLONIDINE .3 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54868-6261_3589976f-2ec4-4f36-b93d-a70679fc67bb 54868-6261 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20110601 NDA AUTHORIZED GENERIC NDA021121 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-6262_3589976f-2ec4-4f36-b93d-a70679fc67bb 54868-6262 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20110601 NDA AUTHORIZED GENERIC NDA021121 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 54868-6265_d1f79ded-7451-46a7-9e44-ed60d9b396f2 54868-6265 HUMAN PRESCRIPTION DRUG Calcitriol calcitriol INJECTION, SOLUTION INTRAVENOUS 20110517 ANDA ANDA075746 Physicians Total Care, Inc. CALCITRIOL 1 mg/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 54868-6266_85c1bdec-b1ed-4394-9ace-359c4df7b4ef 54868-6266 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride hydralazine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110517 ANDA ANDA040730 Physicians Total Care, Inc. HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 54868-6269_d4bd0a6d-9832-4d55-b129-5d2134eeb6c4 54868-6269 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20110607 ANDA ANDA078858 Physicians Total Care, Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-6270_fc40da6f-c716-4b68-83e4-0965a3af825f 54868-6270 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide SPRAY, METERED NASAL 20110914 ANDA ANDA078104 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE 55 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-6271_05616a7e-71b4-4009-a86d-c7fb31d27faa 54868-6271 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20110617 ANDA ANDA065431 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 250; 62.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 54868-6272_01fd5716-bb59-49b0-a0ed-8da299cf060f 54868-6272 HUMAN PRESCRIPTION DRUG Junel 1.5/30 norethindrone acetate and ethinyl estradiol TABLET ORAL 20110621 ANDA ANDA076381 Physicians Total Care, Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 30; 1.5 ug/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 54868-6273_a4c8ea03-e42f-4cc4-9e44-a36cbce1fc4d 54868-6273 HUMAN PRESCRIPTION DRUG Zenchent Norethindrone and Ethinyl Estradiol KIT 20110621 ANDA ANDA078323 Physicians Total Care, Inc. 54868-6274_d4616da6-d4ac-447f-b557-fda34a016e10 54868-6274 HUMAN PRESCRIPTION DRUG Tilia Fe Norethindrone Acetate and Ethinyl Estradiol KIT ORAL 20110621 ANDA ANDA076629 Physicians Total Care, Inc. 54868-6275_f3e8ce92-440e-4ecb-953e-ddf66db8e403 54868-6275 HUMAN PRESCRIPTION DRUG LoSeasonique levonorgestrel/ethinyl estradiol and ethinyl estradiol KIT 20110621 NDA NDA022262 Physicians Total Care, Inc. 54868-6276_a5b8bc86-b90c-43cc-8778-2468f6c09cd4 54868-6276 HUMAN PRESCRIPTION DRUG Seasonique levonorgestrel / ethinyl estradiol and ethinyl estradiol KIT 20110621 NDA NDA021840 Physicians Total Care, Inc. 54868-6277_bb6795d2-632e-4850-ad0c-5396ee97fdd9 54868-6277 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110915 ANDA ANDA076710 Physicians Total Care, Inc. LEVOFLOXACIN 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54868-6278_bb6795d2-632e-4850-ad0c-5396ee97fdd9 54868-6278 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110622 ANDA ANDA076710 Physicians Total Care, Inc. LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54868-6279_bb6795d2-632e-4850-ad0c-5396ee97fdd9 54868-6279 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110622 ANDA ANDA076710 Physicians Total Care, Inc. LEVOFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54868-6280_749ca7b2-0317-497a-bc36-167f5c02dbf3 54868-6280 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20110718 NDA NDA021436 Physicians Total Care, Inc. ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] 54868-6282_cdbc91cb-f696-4d5f-ab5e-449e4c48cbd9 54868-6282 HUMAN PRESCRIPTION DRUG Besivance Besifloxacin SUSPENSION OPHTHALMIC 20110713 NDA NDA022308 Physicians Total Care, Inc. BESIFLOXACIN 6 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 54868-6283_e2fbe47e-392e-40c1-b2cf-2e9cfe026aea 54868-6283 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION/ DROPS OPHTHALMIC 20110719 ANDA ANDA078792 Physicians Total Care, Inc. DICLOFENAC SODIUM 1 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-6284_b2a437d0-1579-4850-914f-f23e0b39b0fc 54868-6284 HUMAN PRESCRIPTION DRUG SPRIX ketorolac tromethamine SPRAY, METERED NASAL 20110720 NDA NDA022382 Physicians Total Care, Inc. KETOROLAC TROMETHAMINE 15.75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-6285_492810e2-d2ef-4f32-99e7-4d670bb48acf 54868-6285 HUMAN PRESCRIPTION DRUG Solodyn minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110718 NDA NDA050808 Physicians Total Care, Inc. MINOCYCLINE HYDROCHLORIDE 80 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 54868-6286_3f282789-eb8c-4437-8f5a-69986949fd16 54868-6286 HUMAN PRESCRIPTION DRUG Tobramycin and Dexamethasone Tobramycin and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 20110725 ANDA ANDA064134 Physicians Total Care, Inc. DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-6287_5d435eaa-c02c-4dd2-8628-e95f1587024c 54868-6287 HUMAN PRESCRIPTION DRUG Brimonidine Tartrate Brimonidine Tartrate SOLUTION/ DROPS OPHTHALMIC 20110725 ANDA ANDA076260 Physicians Total Care, Inc. BRIMONIDINE TARTRATE 2 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 54868-6288_f84fc3bd-4e3a-4212-be3d-cbe5d92a9251 54868-6288 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Augmented Betamethasone Dipropionate LOTION TOPICAL 20110727 ANDA ANDA077111 Physicians Total Care, Inc. BETAMETHASONE DIPROPIONATE .64 mg/mL 54868-6289_f62c7f7c-def1-446d-a173-1dde2c3c714c 54868-6289 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET ORAL 20110727 ANDA ANDA076502 Physicians Total Care, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 54868-6290_2e7982e9-25ac-451a-8d68-df391e85d4fb 54868-6290 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20110729 ANDA ANDA201961 Physicians Total Care, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 54868-6291_1da15065-b1bd-4774-97de-0e260a4556dc 54868-6291 HUMAN PRESCRIPTION DRUG CLOBETASOL PROPIONATE clobetasol propionate AEROSOL, FOAM TOPICAL 20110816 NDA NDA021142 Physicians Total Care, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-6292_27503731-a76c-4dce-9519-5f960e4cd762 54868-6292 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20110906 ANDA ANDA078930 Physicians Total Care, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-6293_14ccb636-1aea-4e6c-9084-e8aa05bd0edf 54868-6293 HUMAN PRESCRIPTION DRUG FLUOROURACIL fluorouracil CREAM TOPICAL 20110906 ANDA ANDA077524 Physicians Total Care, Inc. FLUOROURACIL 50 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 54868-6294_9fd799f7-9bd7-40c6-b003-d27ca9cb0f10 54868-6294 HUMAN PRESCRIPTION DRUG LASTACAFT alcaftadine SOLUTION/ DROPS OPHTHALMIC 20110819 NDA NDA022134 Physicians Total Care, Inc. ALCAFTADINE 2.5 mg/mL 54868-6295_8d6fabef-2442-43f9-b3fa-1d92160beabf 54868-6295 HUMAN PRESCRIPTION DRUG COMBIGAN brimonidine tartrate, timolol maleate SOLUTION/ DROPS OPHTHALMIC 20110829 NDA NDA021398 Physicians Total Care, Inc. BRIMONIDINE TARTRATE; TIMOLOL MALEATE 2; 5 mg/mL; mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 54868-6296_7927cdc5-bfbb-458d-8279-657d4dd70991 54868-6296 HUMAN PRESCRIPTION DRUG DUREZOL DUREZOL EMULSION OPHTHALMIC 20110829 NDA NDA022212 Physicians Total Care, Inc. DIFLUPREDNATE .5 mg/mL 54868-6297_6e2cdf3a-736b-4840-ab54-cfed2fad0d2e 54868-6297 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110830 ANDA ANDA090149 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 54868-6299_dc94c5cc-f078-40a9-9e51-7a171dbe4f37 54868-6299 HUMAN PRESCRIPTION DRUG BEPREVE bepotastine besilate SOLUTION/ DROPS OPHTHALMIC 20110926 NDA NDA022288 Physicians Total Care, Inc. BEPOTASTINE 15 mg/mL Histamine-1 Receptor Antagonist [EPC] 54868-6301_6801466b-ad95-4d88-bd41-d8a167d4d052 54868-6301 HUMAN PRESCRIPTION DRUG Bromday bromfenac SOLUTION/ DROPS OPHTHALMIC 20110930 NDA NDA021664 Physicians Total Care, Inc. BROMFENAC SODIUM .9 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-6302_edd9dcb2-c553-44a8-878e-61ad9642e2b5 54868-6302 HUMAN PRESCRIPTION DRUG Nevanac nepafenac SUSPENSION OPHTHALMIC 20110831 NDA NDA021862 Physicians Total Care, Inc. NEPAFENAC 1 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-6303_c97e8928-c19f-41bd-b3eb-c2c9b8d31437 54868-6303 HUMAN PRESCRIPTION DRUG ZYMAXID gatifloxacin SOLUTION/ DROPS OPHTHALMIC 20110831 NDA NDA022548 Physicians Total Care, Inc. GATIFLOXACIN 5 mg/mL 54868-6304_79525f6c-c645-444a-acc1-93bc46edb8a1 54868-6304 HUMAN PRESCRIPTION DRUG LUMIGAN bimatoprost SOLUTION/ DROPS OPHTHALMIC 20110914 NDA NDA022184 Physicians Total Care, Inc. BIMATOPROST .1 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 54868-6305_73335920-b3f7-43fe-bfef-2b3ed50c1ed3 54868-6305 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate EMULSION TOPICAL 20110907 ANDA ANDA075325 Physicians Total Care, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-6306_e4fe38fa-19f0-4476-9723-e51767dfeb78 54868-6306 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110908 ANDA ANDA075932 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 54868-6307_3bb13bf6-83da-41af-afb5-46ccd13314a3 54868-6307 HUMAN PRESCRIPTION DRUG Claravis isotretinoin CAPSULE ORAL 20110914 ANDA ANDA076135 Physicians Total Care, Inc. ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-6308_3bb13bf6-83da-41af-afb5-46ccd13314a3 54868-6308 HUMAN PRESCRIPTION DRUG Claravis isotretinoin CAPSULE ORAL 20110920 ANDA ANDA076135 Physicians Total Care, Inc. ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-6309_7640cf93-5a17-4129-829b-f4a77bbda31e 54868-6309 HUMAN PRESCRIPTION DRUG ONGLYZA SAXAGLIPTIN TABLET, FILM COATED ORAL 20110922 NDA NDA022350 Physicians Total Care, Inc. SAXAGLIPTIN HYDROCHLORIDE 5 mg/1 54868-6310_f72892dc-01cf-4e66-a841-aae20aa65500 54868-6310 HUMAN PRESCRIPTION DRUG Clonidine Clonidine PATCH TRANSDERMAL 20110924 ANDA ANDA076157 Physicians Total Care, Inc. CLONIDINE .1 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 54868-6311_58971aed-8e11-476b-b52f-d0f60a37532a 54868-6311 HUMAN OTC DRUG Silace Docusate sodium SYRUP ORAL 20110922 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. DOCUSATE SODIUM 60 mg/15mL 54868-6312_d30f22f1-8c60-4072-bcdb-ac5d41edb796 54868-6312 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 20110924 ANDA ANDA074091 Physicians Total Care, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 54868-6315_88cfbec5-a553-46d5-bbfc-2c3a29b7f171 54868-6315 HUMAN PRESCRIPTION DRUG Tamiflu Oseltamivir Phosphate POWDER, FOR SUSPENSION ORAL 20111103 NDA NDA021246 Physicians Total Care, Inc. OSELTAMIVIR PHOSPHATE 6 mg/mL Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] 54868-6316_011fff61-3327-45a3-ba99-86c12b9c28f3 54868-6316 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111122 ANDA ANDA091430 Physicians Total Care, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 54868-6317_3a7c03fe-ca67-489d-a42d-0efedd312f08 54868-6317 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20111117 NDA NDA022047 Physicians Total Care, Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 54868-6319_7253c7c7-5bb8-4cab-b5df-870da5afa189 54868-6319 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111202 ANDA ANDA076477 Physicians Total Care, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-6320_7253c7c7-5bb8-4cab-b5df-870da5afa189 54868-6320 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111202 ANDA ANDA076477 Physicians Total Care, Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-6321_7253c7c7-5bb8-4cab-b5df-870da5afa189 54868-6321 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Physicians Total Care, Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-6322_7253c7c7-5bb8-4cab-b5df-870da5afa189 54868-6322 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111202 ANDA ANDA076477 Physicians Total Care, Inc. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-6323_495988fd-328f-485b-9dc8-cfc1a47baa05 54868-6323 HUMAN PRESCRIPTION DRUG CALCITONIN SALMON CALCITONIN SALMON SPRAY, METERED NASAL 20111209 ANDA ANDA076979 Physicians Total Care, Inc. CALCITONIN SALMON 200 [iU]/.09mL Calcitonin [Chemical/Ingredient],Calcitonin [EPC] 54868-6325_803d538c-3eeb-4c67-97a1-40da1861fc84 54868-6325 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20120104 ANDA ANDA076388 Physicians Total Care, Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 54868-6326_5b1c1400-be20-4fd6-b6c5-e23cbbcc70bd 54868-6326 HUMAN PRESCRIPTION DRUG Flavoxate Hydrochloride Flavoxate hydrochloride TABLET, FILM COATED ORAL 20120104 ANDA ANDA076835 Physicians Total Care, Inc. FLAVOXATE HYDROCHLORIDE 100 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 54868-6328_f4787f96-c069-4268-94ae-1f4124ce744f 54868-6328 HUMAN PRESCRIPTION DRUG JALYN dutasteride and tamsulosin hydrochloride CAPSULE ORAL 20120502 NDA NDA022460 Physicians Total Care, Inc. DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE .5; .4 mg/1; mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA],Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 54868-6329_1181b5ce-a033-4c2b-9896-1ab91a2afa82 54868-6329 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120222 ANDA ANDA079013 Physicians Total Care, Inc. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 54868-6330_a426eea0-b0a5-47b4-bbef-e7a99f7382ab 54868-6330 HUMAN PRESCRIPTION DRUG Dorzolamide HCl Dorzolamide HCl SOLUTION/ DROPS OPHTHALMIC 20120221 ANDA ANDA090143 Physicians Total Care, Inc. DORZOLAMIDE HYDROCHLORIDE 22.3 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] 54868-6333_a9c924a5-bee1-42b4-b2e1-1c1e3a735d16 54868-6333 HUMAN PRESCRIPTION DRUG Staxyn vardenafil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20120308 NDA NDA200179 Physicians Total Care, Inc. VARDENAFIL HYDROCHLORIDE 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 54868-6335_0af0a750-cbab-47c1-94dd-0aeb79223118 54868-6335 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20120308 NDA AUTHORIZED GENERIC NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 54868-6336_caa6984e-ab98-4bdd-bcef-815234f39cd6 54868-6336 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20120525 ANDA ANDA076273 Physicians Total Care, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 54868-6338_3cdc5675-e9d8-4fbf-ba64-76de322eb9ad 54868-6338 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Physicians Total Care, Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 54868-6339_3cdc5675-e9d8-4fbf-ba64-76de322eb9ad 54868-6339 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Physicians Total Care, Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 54868-6340_3cdc5675-e9d8-4fbf-ba64-76de322eb9ad 54868-6340 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Physicians Total Care, Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 54868-6341_3cdc5675-e9d8-4fbf-ba64-76de322eb9ad 54868-6341 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Physicians Total Care, Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 54868-6342_3cdc5675-e9d8-4fbf-ba64-76de322eb9ad 54868-6342 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120412 ANDA ANDA077380 Physicians Total Care, Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 54868-6343_254b8a76-f73d-4eb1-91c5-d85317fe8d24 54868-6343 HUMAN PRESCRIPTION DRUG Bromfenac Bromfenac sodium SOLUTION/ DROPS OPHTHALMIC 20120413 ANDA ANDA201211 Physicians Total Care, Inc. BROMFENAC SODIUM 1.035 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 54868-6347_30bbf95e-6db5-4492-9a74-35def0e35cb5 54868-6347 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL TOPICAL 20120426 ANDA ANDA201759 Physicians Total Care, Inc. FLUOCINOLONE ACETONIDE .11 mg/118.28mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-6348_d2feb064-34c3-4e0b-b296-7ee359e25714 54868-6348 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20120426 ANDA ANDA065302 Physicians Total Care, Inc. AZITHROMYCIN ANHYDROUS 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 54868-6352_7617cef4-5cf8-4679-af41-a5bf71fc6f7a 54868-6352 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole GEL VAGINAL 20120604 NDA AUTHORIZED GENERIC NDA020208 Physicians Total Care, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 54868-6355_08609137-e587-4a8f-a69e-cdd93d3aa81a 54868-6355 HUMAN PRESCRIPTION DRUG PRED MILD prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 20121101 NDA NDA017100 Physicians Total Care, Inc. PREDNISOLONE ACETATE 1.2 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-6358_b53caa4a-514f-4516-8dd4-e86d830db65c 54868-6358 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120702 ANDA ANDA076000 Physicians Total Care, Inc. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 54868-6360_95d80140-58d3-4503-ad30-7fb7bc80dc74 54868-6360 HUMAN PRESCRIPTION DRUG COMPLERA emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20130201 NDA NDA202123 Physicians Total Care, Inc. EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE 200; 25; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [Chemical/Ingredient],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 54868-6361_1006e476-bae4-4924-bb59-9f8a5bfaba73 54868-6361 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120809 ANDA ANDA078605 Physicians Total Care, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 54868-6362_1006e476-bae4-4924-bb59-9f8a5bfaba73 54868-6362 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120809 ANDA ANDA078723 Physicians Total Care, Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 54868-6363_1006e476-bae4-4924-bb59-9f8a5bfaba73 54868-6363 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120809 ANDA ANDA078723 Physicians Total Care, Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 54868-6364_b53caa4a-514f-4516-8dd4-e86d830db65c 54868-6364 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120822 ANDA ANDA076000 Physicians Total Care, Inc. OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 54868-6365_b53caa4a-514f-4516-8dd4-e86d830db65c 54868-6365 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120822 ANDA ANDA076000 Physicians Total Care, Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 54868-6366_de3cdf95-dde1-4bc3-9149-c75f55197be5 54868-6366 HUMAN PRESCRIPTION DRUG Myorisan isotretinoin CAPSULE, LIQUID FILLED ORAL 20120823 ANDA ANDA076485 Physicians Total Care, Inc. ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-6368_26d15de0-e8b5-4f82-9c43-624f7f510a6a 54868-6368 HUMAN PRESCRIPTION DRUG Intelence etravirine TABLET ORAL 20121010 NDA NDA022187 Physicians Total Care, Inc. ETRAVIRINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] 54868-6369_04f573ea-41f5-4891-b474-eb19b2e6caa2 54868-6369 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20121016 NDA NDA021976 Physicians Total Care, Inc. DARUNAVIR ETHANOLATE 600 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] 54868-6370_5be54e0d-3b7a-44be-8af0-2c7c9e3f9dea 54868-6370 HUMAN PRESCRIPTION DRUG Viramune nevirapine TABLET, EXTENDED RELEASE ORAL 20130123 NDA NDA201152 Physicians Total Care, Inc. NEVIRAPINE 400 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 54868-6375_babd0b6a-0ecb-49f3-b598-12eaac98db60 54868-6375 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20121016 NDA NDA021323 Physicians Total Care, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-6376_babd0b6a-0ecb-49f3-b598-12eaac98db60 54868-6376 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20121016 NDA NDA021323 Physicians Total Care, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54868-6377_31cfbadd-b2cf-45c1-b28b-266e12c3f8dd 54868-6377 HUMAN PRESCRIPTION DRUG BromfedDM DM Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide SYRUP ORAL 20121026 ANDA ANDA088811 Physicians Total Care, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 10; 30 mg/5mL; mg/5mL; mg/5mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] 54868-6378_de3cdf95-dde1-4bc3-9149-c75f55197be5 54868-6378 HUMAN PRESCRIPTION DRUG Myorisan isotretinoin CAPSULE, LIQUID FILLED ORAL 20121029 ANDA ANDA076485 Physicians Total Care, Inc. ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-6379_0cfa1b9a-07e6-4e7a-80c2-e62716be2abd 54868-6379 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride oxymorphone hydrochloride TABLET ORAL 20121210 ANDA ANDA090964 Physicians Total Care, Inc. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-6381_56e02cdd-dd44-419f-896c-9db80dc2f6f4 54868-6381 HUMAN OTC DRUG biclora Chlophedianol Hydrochloride, Chlorcyclizine Hydrochloride LIQUID ORAL 20130102 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. CHLOPHEDIANOL HYDROCHLORIDE; CHLORCYCLIZINE HYDROCHLORIDE 12.5; 12.5 mg/5mL; mg/5mL 54868-6383_82d5e146-c8ff-4a69-99d9-17345831c8aa 54868-6383 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL TOPICAL 20121207 ANDA ANDA201764 Physicians Total Care, Inc. FLUOCINOLONE ACETONIDE .11 mg/118.28mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-6384_119e5ec4-4a4c-4ee1-9cfe-846290af31ca 54868-6384 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20121207 NDA AUTHORIZED GENERIC NDA021208 Physicians Total Care, Inc. MIRTAZAPINE 45 mg/1 54868-6387_92625c0a-0173-482e-85b5-ddcf79c261a9 54868-6387 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20121231 NDA NDA021217 Physicians Total Care, Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-6388_92625c0a-0173-482e-85b5-ddcf79c261a9 54868-6388 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20121231 NDA NDA021217 Physicians Total Care, Inc. HYDROMORPHONE HYDROCHLORIDE 16 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 54868-6393_2deac9e5-a087-4ffc-a615-971a10d22ca5 54868-6393 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20130123 ANDA ANDA091211 Physicians Total Care, Inc. ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 54868-6394_b18741bc-0510-4cce-b98c-8669cf0bb9cb 54868-6394 HUMAN PRESCRIPTION DRUG rizatriptan benzoate rizatriptan benzoate TABLET ORAL 20130123 ANDA ANDA201967 Physicians Total Care, Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 54868-6397_3f8c45b5-fd8c-41b5-acc9-efaa7c846733 54868-6397 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130129 ANDA ANDA078173 Physicians Total Care, Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 54868-6406_d857b220-9912-4908-8733-f904a6402b8e 54868-6406 HUMAN PRESCRIPTION DRUG AXIRON testosterone SOLUTION TOPICAL 20130906 NDA NDA022504 Physicians Total Care, Inc. TESTOSTERONE 30 mg/1.5mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 54868-6407_54766c05-7e5a-4e05-96fe-0e81cd6885ae 54868-6407 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20131011 ANDA ANDA040355 Physicians Total Care, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 54868-6425_3bb8e94b-5395-4d6b-a835-12aa4570a5dd 54868-6425 HUMAN PRESCRIPTION DRUG ZENATANE ISOTRETINOIN CAPSULE, GELATIN COATED ORAL 20140516 ANDA ANDA202099 Physicians Total Care, Inc. ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-6426_3bb8e94b-5395-4d6b-a835-12aa4570a5dd 54868-6426 HUMAN PRESCRIPTION DRUG ZENATANE ISOTRETINOIN CAPSULE, GELATIN COATED ORAL 20140516 ANDA ANDA202099 Physicians Total Care, Inc. ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 54868-6435_eaa6c757-097c-4e9a-84b4-e4dfc403e18a 54868-6435 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20140912 NDA NDA022210 Physicians Total Care, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 55000; 10000; 34000 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 54868-6437_6a2d0700-c293-4469-a52e-122e609182b7 54868-6437 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate, Acetaminophen SOLUTION ORAL 20140912 ANDA ANDA040894 Physicians Total Care, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII 54868-6624_53d9403e-108e-41aa-9d41-ff2719b8d682 54868-6624 HUMAN PRESCRIPTION DRUG METHYLPREDNISOLONE methylprednisolone TABLET ORAL 19941129 ANDA ANDA040232 Physicians Total Care, Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54868-6745_3608af1c-615a-4829-90bd-4a7c84a3a8b8 54868-6745 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 19930917 ANDA ANDA064048 Physicians Total Care, Inc. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 54879-001_3f6428d6-3745-4337-ad78-ebfff9f49135 54879-001 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET, FILM COATED ORAL 20061215 NDA AUTHORIZED GENERIC NDA016320 STI Pharma LLC ETHAMBUTOL HYDROCHLORIDE 100 mg/1 Antimycobacterial [EPC] 54879-002_3f6428d6-3745-4337-ad78-ebfff9f49135 54879-002 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET, FILM COATED ORAL 20061215 NDA AUTHORIZED GENERIC NDA016320 STI Pharma LLC ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] 54879-003_2240ce6b-7bd9-47d5-92d0-75427b8117ba 54879-003 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone ELIXIR ORAL 19760921 ANDA ANDA084754 STI Pharma LLC DEXAMETHASONE .5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54879-004_dfcea874-e7c9-44da-90ce-7a13239510d1 54879-004 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate LOTION CUTANEOUS 19850731 ANDA ANDA070052 STI Pharma BETAMETHASONE VALERATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 54879-005_70380ccb-f06b-4f21-aaf9-185049a26ce7 54879-005 HUMAN PRESCRIPTION DRUG Triacin-C TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP SYRUP ORAL 20130101 ANDA ANDA088704 STI Pharma LLC CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 10; 30; 1.25 mg/5mL; mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] CV 54879-006_81d61502-83a3-49c7-8aac-85f1a3cb91a1 54879-006 HUMAN PRESCRIPTION DRUG Hydroxyzine HCl Hydroxyzine HCl SOLUTION ORAL 19820101 ANDA ANDA086880 STI Pharma LLC HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 54879-007_95ae9b0f-f4f9-499a-8e80-b05566d9048e 54879-007 HUMAN PRESCRIPTION DRUG SULFATRIM Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 19830701 NDA NDA018615 STI Pharma LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 54879-009_1c43a586-9ff7-4529-9722-b82245968f35 54879-009 HUMAN PRESCRIPTION DRUG escitalopram escitalopram TABLET, FILM COATED ORAL 20130912 ANDA ANDA077512 STI Pharma LLC ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54879-010_1c43a586-9ff7-4529-9722-b82245968f35 54879-010 HUMAN PRESCRIPTION DRUG escitalopram escitalopram TABLET, FILM COATED ORAL 20130912 ANDA ANDA077512 STI Pharma LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54879-011_1c43a586-9ff7-4529-9722-b82245968f35 54879-011 HUMAN PRESCRIPTION DRUG escitalopram escitalopram TABLET, FILM COATED ORAL 20130912 ANDA ANDA077512 STI Pharma LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 54891-001_349765d3-ac03-48f9-ab37-5b92676b902f 54891-001 HUMAN OTC DRUG Viva Polysorbate 80 SOLUTION/ DROPS OPHTHALMIC 19870219 OTC MONOGRAPH FINAL part349 Dakota Laboratories, LLC POLYSORBATE 80 100 mg/10mL 54897-507_7b7d2cf0-08d2-4ee2-b0ea-c5d77163acf8 54897-507 HUMAN PRESCRIPTION DRUG Topical Fluoride Foam Bumble Bee Bubble Gum Acidulated Phosphate Fluoride AEROSOL DENTAL 20000504 UNAPPROVED DRUG OTHER Laclede, Inc. HYDROFLUORIC ACID; SODIUM FLUORIDE 2.3; 10 mg/g; mg/g 54897-601_87a1ddfc-60de-46e3-ab29-b775fe4b6d96 54897-601 HUMAN OTC DRUG LUVENA FEMININE WIPES Pramoxine Hydrochloride CLOTH TOPICAL 20120404 OTC MONOGRAPH FINAL part346 LACLEDE, INC. PRAMOXINE HYDROCHLORIDE 10 mg/1000mg 54913-001_ffde6a12-9b9a-49c4-a26c-62bc5ea00d1c 54913-001 HUMAN OTC DRUG SWEATBLOCK ALUMINUM CHLORIDE LIQUID TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part350 DC Alpine Partners, LLC DBA: Sweatblock ALUMINUM CHLORIDE 14 mL/100mL 54948-100_128612bd-2440-432c-8858-53ab6a66aa55 54948-100 HUMAN OTC DRUG BAEKNYONDONGAN TREATMENT WITCH HAZEL SOLUTION TOPICAL 20110803 OTC MONOGRAPH FINAL part347 MIX & MATCH CO., LTD. WITCH HAZEL .55 mL/550mL 54948-110_f3d5a97c-6e3f-4889-ac96-21d9d89e8ddd 54948-110 HUMAN OTC DRUG BAEKNYONDONGAN CHI WITCH HAZEL SHAMPOO TOPICAL 20110803 OTC MONOGRAPH FINAL part347 MIX & MATCH CO., LTD. WITCH HAZEL .55 mL/550mL 54949-001_0b24b6a6-b51e-4c88-a98c-eb2f0ea35044 54949-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19861201 UNAPPROVED MEDICAL GAS ABCO Welding and Industrial Supply Inc OXYGEN 995 mL/L 54949-002_75196dac-aea4-478a-9f4f-99795f72e091 54949-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19970812 UNAPPROVED MEDICAL GAS ABCO Welding and Industrial Supply Inc NITROGEN 990 mL/L 54949-003_b827b4c7-d7ac-4373-aa49-d82141df1841 54949-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20100501 UNAPPROVED MEDICAL GAS ABCO Welding and Industrial Supply Inc. NITROUS OXIDE 990 mL/L 54949-004_c865e683-db22-4e55-9814-a93b6848daea 54949-004 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20100501 UNAPPROVED MEDICAL GAS ABCO Welding and Industrial Supply Inc CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 54973-0229_55a61004-0308-4c43-babc-e9494f39a563 54973-0229 HUMAN OTC DRUG ARNICAID ARNICA MONTANA, HYPERICUM PERFORATUM, RUTA GRAVEOLENS FLOWERING TOP, LEDUM PALUSTRE TWIG, and BELLIS PERENNIS TABLET, SOLUBLE ORAL 19910717 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP 30; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-0232_06bceefa-741e-4d8e-85b1-0c48942a7583 54973-0232 HUMAN OTC DRUG ARNISPORT ARNICA MONTANA, HYPERICUM PERFORATUM, RUTA GRAVEOLENS FLOWERING TOP, LEDUM PALUSTRE TWIG, BELLIS PERENNIS, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, POTASSIUM PHOSPHATE, DIBASIC, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM SULFATE, and SILICON DIOXIDE TABLET, SOLUBLE ORAL 20000428 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE 30; 6; 6; 3; 3; 6; 6; 3; 3; 3; 3; 6; 6; 6; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-0600_4819322d-0098-4845-b9c4-d13ae0dd3e5a 54973-0600 HUMAN OTC DRUG ACONITE NAPELLIS ACONITUM NAPELLUS ROOT TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ACONITUM NAPELLUS ROOT 6 [hp_X]/1 54973-0601_4c3cfe5b-f480-4bd2-9d10-a28e618385ab 54973-0601 HUMAN OTC DRUG ALLIUM CEPA ONION TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ONION 6 [hp_X]/1 54973-0602_54ffea5e-77ae-4d4b-b4c1-4cb7a790b286 54973-0602 HUMAN OTC DRUG ANTIMONIUM TART ANTIMONY POTASSIUM TARTRATE TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ANTIMONY POTASSIUM TARTRATE 6 [hp_X]/1 54973-0603_eed11e42-0183-4432-8770-397f4c8e93a0 54973-0603 HUMAN OTC DRUG APIS MELLIFICA APIS MELLIFERA TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's APIS MELLIFERA 6 [hp_X]/1 54973-0604_0984fc69-a1ad-49aa-8829-15ee803099a0 54973-0604 HUMAN OTC DRUG ARNICA MONTANA ARNICA MONTANA TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA 6 [hp_X]/1 54973-0605_8945018f-0519-4785-aeca-3d8c9968c9bb 54973-0605 HUMAN OTC DRUG ARSENICUM ALBUM ARSENIC TRIOXIDE TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ARSENIC TRIOXIDE 6 [hp_X]/1 54973-0606_86abff9d-7db0-41f5-91b9-3076dc878c0b 54973-0606 HUMAN OTC DRUG BELLADONNA ATROPA BELLADONNA ROOT TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ATROPA BELLADONNA ROOT 6 [hp_X]/1 54973-0607_7d2eb5c1-6e6a-4e5d-8d1a-6a5fb5e96791 54973-0607 HUMAN OTC DRUG BRYONIA ALBA BRYONIA ALBA ROOT TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's BRYONIA ALBA ROOT 6 [hp_X]/1 54973-0609_36cf684f-18a5-45fb-9bde-0d2560fddb90 54973-0609 HUMAN OTC DRUG CANTHARIS LYTTA VESICATORIA TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's LYTTA VESICATORIA 6 [hp_X]/1 54973-0610_d8218a5d-b818-4735-9b21-a60b54a7f23e 54973-0610 HUMAN OTC DRUG CARBO VEG ACTIVATED CHARCOAL TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ACTIVATED CHARCOAL 6 [hp_X]/1 54973-0611_50d8641b-c100-492e-befa-905b79b372f3 54973-0611 HUMAN OTC DRUG CHAMOMILLA MATRICARIA CHAMOMILLA FLOWERING TOP OIL TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's MATRICARIA CHAMOMILLA FLOWERING TOP OIL 6 [hp_X]/1 54973-0613_7b205714-5e73-4efa-9974-b927c83f362e 54973-0613 HUMAN OTC DRUG GELSEMIUM SEMP GELSEMIUM SEMPERVIRENS ROOT TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]/1 54973-0614_171ae727-9923-4df5-b36f-d23b3fb19045 54973-0614 HUMAN OTC DRUG HEPAR SULPH. CALC. CALCIUM SULFIDE TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM SULFIDE 6 [hp_X]/1 54973-0615_acb99ac1-f037-4f7e-8b5d-48c77640903d 54973-0615 HUMAN OTC DRUG HYPERICUM PERF HYPERICUM PERFORATUM TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's HYPERICUM PERFORATUM 6 [hp_X]/1 54973-0616_d41288d9-9e14-475f-8124-7e7540fe74ca 54973-0616 HUMAN OTC DRUG IGNATIA AMARA STRYCHNOS IGNATII SEED TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's STRYCHNOS IGNATII SEED 6 [hp_X]/1 54973-0617_81c10641-92db-4189-aa13-25e05b123e91 54973-0617 HUMAN OTC DRUG IPECACUANHA IPECAC TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's IPECAC 6 [hp_X]/1 54973-0618_513a7934-a28b-4773-8144-86a6a07a363a 54973-0618 HUMAN OTC DRUG LEDUM PAL. LEDUM PALUSTRE TWIG TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's LEDUM PALUSTRE TWIG 6 [hp_X]/1 54973-0620_b4b0827f-c311-467b-90cb-11041b84ecd3 54973-0620 HUMAN OTC DRUG MERCURIUS VIVUS MERCURIUS SOLUBILIS TABLET ORAL 19950101 UNAPPROVED HOMEOPATHIC Hyland's MERCURIUS SOLUBILIS 6 [hp_X]/1 54973-0621_9f2f4e2d-9c50-416b-8f0a-024425408469 54973-0621 HUMAN OTC DRUG NUX VOMICA STRYCHNOS NUX-VOMICA SEED TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's STRYCHNOS NUX-VOMICA SEED 6 [hp_X]/1 54973-0622_a599e5d1-d921-4d7e-b7da-df143127ef08 54973-0622 HUMAN OTC DRUG PHOSPHORUS PHOSPHORUS TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's PHOSPHORUS 6 [hp_X]/1 54973-0623_d85e6e0a-fd93-4492-ab41-aee3cdeda7f7 54973-0623 HUMAN OTC DRUG PULSATILLA NIG PULSATILLA VULGARIS TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's PULSATILLA VULGARIS 6 [hp_X]/1 54973-0624_dddf006b-5245-45c0-8106-19845b54fc21 54973-0624 HUMAN OTC DRUG RHUS TOX TOXICODENDRON RADICANS LEAF TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's TOXICODENDRON RADICANS LEAF 6 [hp_X]/1 54973-0625_04887faf-332d-454a-98f2-7bbe3275007d 54973-0625 HUMAN OTC DRUG RUTA GRAV RUTA GRAVEOLENS FLOWERING TOP TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's RUTA GRAVEOLENS FLOWERING TOP 6 [hp_X]/1 54973-0626_29bd9136-bbdf-4455-899b-a5b5289b0860 54973-0626 HUMAN OTC DRUG SPONGIA TOSTA SPONGIA OFFICINALIS SKELETON, ROASTED TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's SPONGIA OFFICINALIS SKELETON, ROASTED 6 [hp_X]/1 54973-0627_d44c19dc-6acf-4b3d-b886-ebd22774441d 54973-0627 HUMAN OTC DRUG SULPHUR SULFUR TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's SULFUR 6 [hp_X]/1 54973-0628_34b64130-46c8-43ff-961a-fd78ba31c688 54973-0628 HUMAN OTC DRUG VERATRUM ALBUM VERATRUM ALBUM ROOT TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's VERATRUM ALBUM ROOT 6 [hp_X]/1 54973-1068_f374654f-dda7-4e1d-99b7-5865175561c8 54973-1068 HUMAN OTC DRUG Bioplasma CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, POTASSIUM PHOSPHATE, DIBASIC, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM SULFATE, and SILICON DIOXIDE TABLET, SOLUBLE ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE 6; 3; 3; 3; 3; 3; 3; 6; 6; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-1069_c0f39950-0694-4ff0-8264-df4b0ef10125 54973-1069 HUMAN OTC DRUG BIOCHEMIC PHOSPHATE TRIBASIC CALCIUM PHOSPHATE, FERROSOFERRIC PHOSPHATE, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, and SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE TABLET ORAL 19790919 UNAPPROVED HOMEOPATHIC Hyland's FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TRIBASIC CALCIUM PHOSPHATE 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-1120_a854b7a5-19cf-449b-a5df-56e75f00ec36 54973-1120 HUMAN OTC DRUG CALMS NERVE TENSION SLEEPLESSNESS PASSIFLORA INCARNATA FLOWER, AVENA SATIVA LEAF, HOPS, and CHAMOMILE TABLET ORAL 19800101 UNAPPROVED HOMEOPATHIC Hyland's AVENA SATIVA LEAF; CHAMOMILE; HOPS; PASSIFLORA INCARNATA FLOWER 1; 2; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-1121_ea0532b1-9444-4dab-823e-6a5618e16afd 54973-1121 HUMAN OTC DRUG CALMS FORTE AVENA SATIVA FLOWERING TOP, CHAMOMILE, HUMULUS LUPULUS STEM, PASSIFLORA INCARNATA FLOWER, CALCIUM PHOSPHATE, FERROSOFERRIC PHOSPHATE, POTASSIUM PHOSPHATE, DIBASIC, SODIUM PHOSPHATE, and MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE TABLET ORAL 19601001 UNAPPROVED HOMEOPATHIC Hyland's AVENA SATIVA FLOWERING TOP; CALCIUM PHOSPHATE; CHAMOMILE; FERROSOFERRIC PHOSPHATE; HUMULUS LUPULUS STEM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PASSIFLORA INCARNATA FLOWER; POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE 1; 3; 2; 3; 1; 3; 1; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-1129_8cc4e606-c9ec-498f-9db4-b9d8a6d51bcc 54973-1129 HUMAN OTC DRUG NERVE TONIC STRESS RELIEF CALCIUM PHOSPHATE, IRON, POTASSIUM PHOSPHATE, UNSPECIFIED FORM, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, and SODIUM PHOSPHATE TABLET ORAL 19700101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM PHOSPHATE; IRON; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM PHOSPHATE, UNSPECIFIED FORM; SODIUM PHOSPHATE 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-1130_1c112911-45b2-4ad9-b4b7-50762b2f8108 54973-1130 HUMAN OTC DRUG Poison Ivy/Oak TOXICODENDRON RADICANS LEAF, CROTON TIGLIUM SEED, and XEROPHYLLUM ASPHODELOIDES TABLET, SOLUBLE ORAL 19940101 UNAPPROVED HOMEOPATHIC Hyland's CROTON TIGLIUM SEED; TOXICODENDRON RADICANS LEAF; XEROPHYLLUM ASPHODELOIDES 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-1157_54bcc381-fd50-4a72-8ddb-ac74483f6724 54973-1157 HUMAN OTC DRUG Hypericum HYPERICUM PERFORATUM SPRAY TOPICAL 20030806 UNAPPROVED HOMEOPATHIC Hyland's HYPERICUM PERFORATUM 1 [hp_X]/mL 54973-2033_5c33e9bd-1253-4d82-aeae-b142e0e8b4c5 54973-2033 HUMAN OTC DRUG CALC FLUOR CALCIUM FLUORIDE TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM FLUORIDE 6 [hp_X]/1 54973-2043_784a0316-8e14-4325-afa5-02910ffcf9da 54973-2043 HUMAN OTC DRUG CALC PHOS CALCIUM PHOSPHATE TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM PHOSPHATE 6 [hp_X]/1 54973-2049_3901e4e5-f697-45c4-aa46-f1808100be7a 54973-2049 HUMAN OTC DRUG CALCIUM SULPHATE CALCIUM SULFATE TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM SULFATE 6 [hp_X]/1 54973-2158_50bcbf3b-eee3-4678-b41e-af06c8844734 54973-2158 HUMAN OTC DRUG DEFEND Cough BRYONIA ALBA ROOT, CAUSTICUM, DROSERA ROTUNDIFOLIA FLOWERING TOP, IPECAC, PHOSPHORUS, RUMEX CRISPUS ROOT, and SPONGIA OFFICINALIS SKELETON, ROASTED SYRUP ORAL 20080402 UNAPPROVED HOMEOPATHIC Hyland's BRYONIA ALBA ROOT; CAUSTICUM; DROSERA ROTUNDIFOLIA FLOWERING TOP; IPECAC; PHOSPHORUS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54973-2900_68bbdbc6-05ef-49a4-a74e-97bfb4613fcd 54973-2900 HUMAN OTC DRUG ACONITE NAPELLIS ACONITUM NAPELLUS ROOT TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ACONITUM NAPELLUS ROOT 30 [hp_X]/1 54973-2901_ba4d67ab-45cc-4e7c-bbbd-88445f42e1f1 54973-2901 HUMAN OTC DRUG ALLIUM CEPA ONION TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ONION 30 [hp_X]/1 54973-2902_efc0f626-1e8c-41a6-96ab-b05324c89bb7 54973-2902 HUMAN OTC DRUG ANTIMONIUM TART ANTIMONY POTASSIUM TARTRATE TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ANTIMONY POTASSIUM TARTRATE 30 [hp_X]/1 54973-2903_ffc87205-34e5-4990-972f-ca22d9d4eef4 54973-2903 HUMAN OTC DRUG APIS MELLIFICA APIS MELLIFERA TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's APIS MELLIFERA 30 [hp_X]/1 54973-2904_fcc4d1d3-e53d-4059-8c0f-1abf44758e96 54973-2904 HUMAN OTC DRUG ARNICA MONTANA ARNICA MONTANA TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA 30 [hp_X]/1 54973-2905_b96d5279-47b7-4469-a4e1-edabcc09cae7 54973-2905 HUMAN OTC DRUG ARSENICUM ALBUM ARSENIC TRIOXIDE TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ARSENIC TRIOXIDE 30 [hp_X]/1 54973-2906_5c8bc2a5-47cc-4949-8eca-9866e5e1fca0 54973-2906 HUMAN OTC DRUG BELLADONNA ATROPA BELLADONNA ROOT TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ATROPA BELLADONNA ROOT 30 [hp_X]/1 54973-2907_a228cee3-c182-40c1-ba2e-615bee1c7266 54973-2907 HUMAN OTC DRUG BRYONIA ALBA BRYONIA ALBA ROOT TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's BRYONIA ALBA ROOT 30 [hp_X]/1 54973-2909_3de7c31a-2cf3-42a1-97d9-c626a16fd408 54973-2909 HUMAN OTC DRUG CANTHARIS LYTTA VESICATORIA TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's LYTTA VESICATORIA 30 [hp_X]/1 54973-2910_e08dea12-809e-4f95-b838-11de4ca8e36f 54973-2910 HUMAN OTC DRUG CARBO VEG ACTIVATED CHARCOAL TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ACTIVATED CHARCOAL 30 [hp_X]/1 54973-2911_72039f4d-7cda-4f21-9569-4fce3163a789 54973-2911 HUMAN OTC DRUG CHAMOMILLA MATRICARIA CHAMOMILLA FLOWERING TOP OIL TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's MATRICARIA CHAMOMILLA FLOWERING TOP OIL 30 [hp_X]/1 54973-2913_55d35e89-f8ad-4dc9-909c-39456541a735 54973-2913 HUMAN OTC DRUG GELSEMIUM SEMP GELSEMIUM SEMPERVIRENS ROOT TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's GELSEMIUM SEMPERVIRENS ROOT 30 [hp_X]/1 54973-2914_167200b0-2298-44a5-b09f-7b0985abb7bd 54973-2914 HUMAN OTC DRUG HEPAR SULPH. CALC. CALCIUM SULFIDE TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM SULFIDE 30 [hp_X]/1 54973-2915_75d194a8-c1f0-44e7-a87c-4f5fb529830e 54973-2915 HUMAN OTC DRUG HYPERICUM PERF HYPERICUM PERFORATUM TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's HYPERICUM PERFORATUM 30 [hp_X]/1 54973-2916_3227ca34-a8be-439a-a646-a0aa88c3b324 54973-2916 HUMAN OTC DRUG IGNATIA AMARA STRYCHNOS IGNATII SEED TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's STRYCHNOS IGNATII SEED 30 [hp_X]/1 54973-2917_17f8c5c5-27be-4aaa-b992-1840b0936325 54973-2917 HUMAN OTC DRUG IPECACUANHA IPECAC TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's IPECAC 30 [hp_X]/1 54973-2918_1b59e76b-1b60-48a6-94bd-8b03d1e4103a 54973-2918 HUMAN OTC DRUG LEDUM PAL LEDUM PALUSTRE TWIG TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's LEDUM PALUSTRE TWIG 30 [hp_X]/1 54973-2920_65219076-6ca4-4267-b72b-37014f1c356c 54973-2920 HUMAN OTC DRUG MERCURIUS VIVUS MERCURIUS SOLUBILIS TABLET ORAL 19950101 UNAPPROVED HOMEOPATHIC Hyland's MERCURIUS SOLUBILIS 30 [hp_X]/1 54973-2921_8ed8a1f3-f463-49ec-989f-0d8e3ab8ca8f 54973-2921 HUMAN OTC DRUG NUX VOMICA STRYCHNOS NUX-VOMICA SEED TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's STRYCHNOS NUX-VOMICA SEED 30 [hp_X]/1 54973-2922_f6b71c8f-ab9c-4687-a368-24239e7d3f37 54973-2922 HUMAN OTC DRUG ClearAc ECHINACEA ANGUSTIFOLIA, BERBERIS VULGARIS ROOT BARK, SULFUR IODIDE, and CALCIUM SULFIDE TABLET, SOLUBLE ORAL 19910901 UNAPPROVED HOMEOPATHIC Hyland's BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA; SULFUR IODIDE 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-2923_237591fa-1507-443b-9be5-517a66136bc8 54973-2923 HUMAN OTC DRUG PULSATILLA NIG PULSATILLA VULGARIS TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's PULSATILLA VULGARIS 30 [hp_X]/1 54973-2924_1ddf735a-8faa-4cbd-a9f9-71f418ec458d 54973-2924 HUMAN OTC DRUG RHUS TOX TOXICODENDRON RADICANS LEAF TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's TOXICODENDRON RADICANS LEAF 30 [hp_X]/1 54973-2925_c252aa8f-3cc6-4d14-825b-6fbbbbb2ad68 54973-2925 HUMAN OTC DRUG RUTA GRAV RUTA GRAVEOLENS FLOWERING TOP TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's RUTA GRAVEOLENS FLOWERING TOP 30 [hp_X]/1 54973-2926_035a4e0c-f2c5-4ccd-a5cb-cab0fe7ce911 54973-2926 HUMAN OTC DRUG SPONGIA TOSTA SPONGIA OFFICINALIS SKELETON, ROASTED TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's SPONGIA OFFICINALIS SKELETON, ROASTED 30 [hp_X]/1 54973-2927_9aa89d09-c7c3-490b-b7f1-9e20f23a74f2 54973-2927 HUMAN OTC DRUG SULPHUR SULFUR TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's SULFUR 30 [hp_X]/1 54973-2928_9313b96f-bc5c-4c03-b08b-ba4b67062858 54973-2928 HUMAN OTC DRUG VERATRUM ALBUM VERATRUM ALBUM ROOT TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's VERATRUM ALBUM ROOT 30 [hp_X]/1 54973-2932_7e8ad134-faf8-40ab-a243-62b1c54b4e63 54973-2932 HUMAN OTC DRUG PHOSPHORUS PHOSPHORUS TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's PHOSPHORUS 30 [hp_X]/1 54973-2950_aec9ee77-fd5a-4cef-bb86-31584658e75b 54973-2950 HUMAN OTC DRUG Headache IRIS VERSICOLOR ROOT, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, and ATROPA BELLADONNA TABLET, SOLUBLE ORAL 19880718 UNAPPROVED HOMEOPATHIC Hyland's ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; IRIS VERSICOLOR ROOT 6; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-2951_eb281754-70ff-4e9c-a2bb-fd9774801531 54973-2951 HUMAN OTC DRUG GAS NUTMEG, ASAFETIDA, STRYCHNOS IGNATII SEED, and LYCOPODIUM CLAVATUM SPORE TABLET, SOLUBLE ORAL 19830404 UNAPPROVED HOMEOPATHIC Hyland's ASAFETIDA; LYCOPODIUM CLAVATUM SPORE; NUTMEG; STRYCHNOS IGNATII SEED 3; 6; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-2952_a3fc1d14-3d4a-4d3b-a231-34b8fe082ab3 54973-2952 HUMAN OTC DRUG FLU EUPATORIUM PERFOLIATUM FLOWERING TOP, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, EUPHRASIA STRICTA, POTASSIUM IODIDE, and CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE TABLET, SOLUBLE ORAL 19940809 UNAPPROVED HOMEOPATHIC Hyland's BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 3; 200; 3; 3; 3; 3 [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-2953_494f22fb-3d1a-4695-b447-710b13b14b11 54973-2953 HUMAN OTC DRUG Bladder Irritation RHUS AROMATICA ROOT BARK, BENZOIC ACID, EQUISETUM HYEMALE, SILVER NITRATE, and LYTTA VESICATORIA TABLET, SOLUBLE ORAL 19950418 UNAPPROVED HOMEOPATHIC Hyland's BENZOIC ACID; EQUISETUM HYEMALE; LYTTA VESICATORIA; RHUS AROMATICA ROOT BARK; SILVER NITRATE 3; 3; 12; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-2954_a78d9231-9273-4795-bbf2-ce97ceedd0d5 54973-2954 HUMAN OTC DRUG Bronchial Cough RUMEX CRISPUS ROOT, SANGUINARIA CANADENSIS ROOT, and POTASSIUM DICHROMATE TABLET, SOLUBLE ORAL 19940809 UNAPPROVED HOMEOPATHIC Hyland's POTASSIUM DICHROMATE; RUMEX CRISPUS ROOT; SANGUINARIA CANADENSIS ROOT 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-2955_91f9f5c5-b7e8-460f-8c07-cf823d32f0e7 54973-2955 HUMAN OTC DRUG ARTHRITIS PAIN FORMULA ARNICA MONTANA, BLACK COHOSH, GUAIACUM OFFICINALE RESIN, BRYONIA ALBA ROOT, and TOXICODENDRON PUBESCENS LEAF TABLET, SOLUBLE ORAL 19940525 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA; BLACK COHOSH; BRYONIA ALBA ROOT; GUAIACUM OFFICINALE RESIN; TOXICODENDRON PUBESCENS LEAF 6; 3; 3; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-2956_1530cec6-2f4c-4836-977b-d9e5ab895ba5 54973-2956 HUMAN OTC DRUG LEG CRAMPS CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, and VISCUM ALBUM FRUITING TOP TABLET, SOLUBLE ORAL 19951204 UNAPPROVED HOMEOPATHIC Hyland's ACONITUM NAPELLUS; CINCHONA OFFICINALIS BARK; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP 6; 3; 6; 6; 3; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-2957_88058e53-480a-4a8f-9361-043f95eb26c5 54973-2957 HUMAN OTC DRUG PMS VIBURNUM OPULUS BARK, CAULOPHYLLUM THALICTROIDES ROOT, ANAMIRTA COCCULUS SEED, and GELSEMIUM SEMPERVIRENS ROOT TABLET, SOLUBLE ORAL 19970926 UNAPPROVED HOMEOPATHIC Hyland's ANAMIRTA COCCULUS SEED; CAULOPHYLLUM THALICTROIDES ROOT; GELSEMIUM SEMPERVIRENS ROOT; VIBURNUM OPULUS BARK 3; 3; 3; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-2958_b90b47f0-5628-4828-974d-ec476d4d8ffd 54973-2958 HUMAN OTC DRUG Indigestion CINCHONA OFFICINALIS BARK, GOLDENSEAL, PHOSPHORIC ACID, and POTASSIUM DICHROMATE TABLET, SOLUBLE ORAL 19890524 UNAPPROVED HOMEOPATHIC Hyland's CINCHONA OFFICINALIS BARK; GOLDENSEAL; PHOSPHORIC ACID; POTASSIUM DICHROMATE 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-2961_72fe61c7-12a9-4d7d-8738-d285def7f0d4 54973-2961 HUMAN OTC DRUG Menstrual Cramps MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, and PULSATILLA VULGARIS TABLET, SOLUBLE ORAL 19950418 UNAPPROVED HOMEOPATHIC Hyland's BLACK COHOSH; CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PULSATILLA VULGARIS 12; 12; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-2965_3b137558-9b90-4cfb-8f42-88046ddbb982 54973-2965 HUMAN OTC DRUG BACKACHE WITH ARNICA BENZOIC ACID, COLCHICUM AUTUMNALE BULB, SULFUR, ARNICA MONTANA, and TOXICODENDRON PUBESCENS LEAF TABLET, SOLUBLE ORAL 19990515 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA; BENZOIC ACID; COLCHICUM AUTUMNALE BULB; SULFUR; TOXICODENDRON PUBESCENS LEAF 6; 3; 3; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3012_6467de63-8707-452a-9362-3ccc3e33f113 54973-3012 HUMAN OTC DRUG Seasonal Allergy Relief ONION, SODIUM CHLORIDE, HISTAMINE DIHYDROCHLORIDE, CUCUMBER, GALPHIMIA GLAUCA FLOWERING TOP, and STRYCHNOS NUX-VOMICA SEED TABLET, SOLUBLE ORAL 20020529 UNAPPROVED HOMEOPATHIC Hyland's CUCUMBER; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; ONION; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 12; 12; 12; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3013_b8bf73e5-3199-4d6a-8bbf-3c06a7544d95 54973-3013 HUMAN OTC DRUG Migraine Headache Relief NITROGLYCERIN, ATROPA BELLADONNA, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, IRIS VERSICOLOR ROOT, and SANGUINARIA CANADENSIS ROOT TABLET, SOLUBLE ORAL 19991011 UNAPPROVED HOMEOPATHIC Hyland's ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; NITROGLYCERIN; SANGUINARIA CANADENSIS ROOT; STRYCHNOS NUX-VOMICA SEED 6; 6; 6; 12; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3014_f30d0a49-8a8d-4691-afbf-f5ad7fa77734 54973-3014 HUMAN OTC DRUG NERVE TONIC CALCIUM PHOSPHATE, IRON, POTASSIUM PHOSPHATE, UNSPECIFIED FORM, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, and SODIUM PHOSPHATE TABLET ORAL 19700101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM PHOSPHATE; IRON; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM PHOSPHATE, UNSPECIFIED FORM; SODIUM PHOSPHATE 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3015_3c5a71db-6e18-4652-8bb4-04e11d5ef036 54973-3015 HUMAN OTC DRUG COMPLETE FLU CARE EUPATORIUM PERFOLIATUM FLOWERING TOP, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, EUPHRASIA STRICTA, POTASSIUM IODIDE, and CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE TABLET, SOLUBLE ORAL 20040602 UNAPPROVED HOMEOPATHIC Hyland's BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 3; 200; 3; 3; 3; 3 [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3016_0a56407b-26cc-438d-a5d5-5f07aa1b5d6e 54973-3016 HUMAN OTC DRUG Complete Flu Care 4 Kids EUPATORIUM PERFOLIATUM FLOWERING TOP, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, EUPHRASIA STRICTA, POTASSIUM IODIDE, and CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE TABLET, SOLUBLE ORAL 20060511 UNAPPROVED HOMEOPATHIC Hyland's BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 3; 200; 3; 3; 3; 3 [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3075_8ccb7225-5a2f-41dd-bf29-6cbdc104cec9 54973-3075 HUMAN OTC DRUG Cold n Cough 4 Kids ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, and GOLDENSEAL LIQUID ORAL 20080801 UNAPPROVED HOMEOPATHIC HYLAND'S, INC. CALCIUM SULFIDE; GOLDENSEAL; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM CHLORIDE; SULFUR 12; 6; 6; 12; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54973-3084_20091357-5f44-46f2-865a-14a55bf5a358 54973-3084 HUMAN OTC DRUG ARNICA ARNICA MONTANA TABLET, SOLUBLE ORAL 20081217 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA 30 [hp_X]/1 54973-3085_6ac7136a-9d8c-4b6d-897e-440e590b231d 54973-3085 HUMAN OTC DRUG MUSCLE THERAPY WITH ARNICA ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, and RUTA GRAVEOLENS FLOWERING TOP GEL TOPICAL 20090115 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP 2; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 54973-3093_f6860f8b-1ce6-4d54-9001-eefb9f4e849d 54973-3093 HUMAN OTC DRUG Leg Cramps PM OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, and SULFUR TABLET, SOLUBLE ORAL 20100101 UNAPPROVED HOMEOPATHIC Hyland's CAUSTICUM; CINCHONA OFFICINALIS BARK; COPPER; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; SULFUR; TOXICODENDRON PUBESCENS LEAF 12; 3; 12; 12; 6; 6; 12; 12; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3097_f92e6d0c-f759-43f3-9b83-8540d4d2e055 54973-3097 HUMAN OTC DRUG Complete Allergy 4 Kids ACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, and SCHOENOCAULON OFFICINALE SEED LIQUID ORAL 20100701 UNAPPROVED HOMEOPATHIC Hyland's, Inc. ACONITUM NAPELLUS; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; ONION; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 6; 6; 12; 12; 12; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54973-3098_c6b4e853-2e79-4065-b371-7fa30632e7cb 54973-3098 HUMAN OTC DRUG Nighttime Cold n Cough 4 Kids ONION, COFFEE BEAN, CHAMOMILE, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA VULGARIS, and SULFUR LIQUID ORAL 20100701 UNAPPROVED HOMEOPATHIC Hyland's, Inc. CALCIUM SULFIDE; CHAMOMILE; COFFEE BEAN; GOLDENSEAL; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 6; 6; 6; 6; 12; 6; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54973-3101_07aedbeb-2957-4b8c-9d38-c0f642b996a1 54973-3101 HUMAN OTC DRUG CALC FLUOR CALCIUM FLUORIDE TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM FLUORIDE 30 [hp_X]/1 54973-3102_8283c087-b6f8-424c-ba30-907f513a0a8b 54973-3102 HUMAN OTC DRUG CALC PHOS CALCIUM PHOSPHATE TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM PHOSPHATE 30 [hp_X]/1 54973-3103_087ed624-860b-46e4-ae23-2298c45a6ad2 54973-3103 HUMAN OTC DRUG CALCIUM SULPHATE CALCIUM SULFATE TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM SULFATE 30 [hp_X]/1 54973-3104_521080aa-a580-4537-961f-d6ab1f67f282 54973-3104 HUMAN OTC DRUG FERRUM PHOSPHATE SODIUM PHOSPHATE TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's SODIUM PHOSPHATE 30 [hp_X]/1 54973-3105_7ff5ff58-32df-476a-adc9-63fb4c4de7da 54973-3105 HUMAN OTC DRUG KALI MURIATICUM POTASSIUM CHLORIDE TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's POTASSIUM CHLORIDE 30 [hp_X]/1 54973-3106_fdd5fe5b-45e3-442d-ac7e-5f5b7a1045a1 54973-3106 HUMAN OTC DRUG KALI PHOS POTASSIUM PHOSPHATE, UNSPECIFIED FORM TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's POTASSIUM PHOSPHATE, UNSPECIFIED FORM 30 [hp_X]/1 54973-3107_96398785-53af-490a-8cf2-2423ee588784 54973-3107 HUMAN OTC DRUG KALI SULPH POTASSIUM SULFATE TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's POTASSIUM SULFATE 30 [hp_X]/1 54973-3108_a993bd4a-296d-4cd2-875f-61573919f961 54973-3108 HUMAN OTC DRUG MAGNESIA PHOS MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE TABLET ORAL 19600101 UNAPPROVED HOMEOPATHIC Hyland's MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 30 [hp_X]/1 54973-3109_a63702f1-90bc-42e2-b63c-95ebe1295499 54973-3109 HUMAN OTC DRUG NATRUM MURIATICUM SODIUM CHLORIDE TABLET ORAL 19600101 UNAPPROVED HOMEOPATHIC Hyland's SODIUM CHLORIDE 30 [hp_X]/1 54973-3110_9d1c9b7e-f318-4a85-a592-9813ab492cb7 54973-3110 HUMAN OTC DRUG NAT. PHOS. SODIUM PHOSPHATE, DIBASIC, ANHYDROUS TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 30 [hp_X]/1 54973-3111_2da837d5-263f-4b9a-b2be-7cf22eacf36b 54973-3111 HUMAN OTC DRUG NAT SULPH SODIUM SULFATE ANHYDROUS TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's SODIUM SULFATE ANHYDROUS 30 [hp_X]/1 54973-3112_7723de70-90e3-4530-8340-eb252a42c235 54973-3112 HUMAN OTC DRUG SILICEA SILICON DIOXIDE TABLET ORAL 19600101 UNAPPROVED HOMEOPATHIC Hyland's SILICON DIOXIDE 30 [hp_X]/1 54973-3113_4dbc2b0c-7fc9-4944-89e8-71af8a969a3e 54973-3113 HUMAN OTC DRUG CALMS FORTE AVENA SATIVA FLOWERING TOP, CHAMOMILE, HUMULUS LUPULUS STEM, PASSIFLORA INCARNATA FLOWER, CALCIUM PHOSPHATE, FERROSOFERRIC PHOSPHATE, POTASSIUM PHOSPHATE, DIBASIC, SODIUM PHOSPHATE, and MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE TABLET ORAL 19601001 UNAPPROVED HOMEOPATHIC Hyland's AVENA SATIVA FLOWERING TOP; CALCIUM PHOSPHATE; CHAMOMILE; FERROSOFERRIC PHOSPHATE; HUMULUS LUPULUS STEM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PASSIFLORA INCARNATA FLOWER; POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE 1; 3; 2; 3; 1; 3; 1; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3114_9d972ead-aed5-41f5-93b3-537fa0f82f6e 54973-3114 HUMAN OTC DRUG LEG CRAMPS CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, and VISCUM ALBUM FRUITING TOP TABLET, SOLUBLE ORAL 19951204 UNAPPROVED HOMEOPATHIC Hyland's ACONITUM NAPELLUS; CINCHONA OFFICINALIS BARK; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP 6; 3; 6; 6; 3; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3122_61cd67d1-d7d6-4094-84e3-af11f3e80740 54973-3122 HUMAN OTC DRUG BIOPLASMA SPORT WITH ELECTROLYTES CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM SULFATE, and SILICON DIOXIDE POWDER ORAL 20110406 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE 6; 3; 3; 3; 3; 3; 6; 6; 3; 3; 3 [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g 54973-3123_642b3129-7bc6-48eb-ab97-e6f835d51f2b 54973-3123 HUMAN OTC DRUG Defend Cold and Cough Night ONION, COFFEE BEAN, CHAMOMILE, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA VULGARIS, and SULFUR LIQUID ORAL 20110617 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM SULFIDE; CHAMOMILE; COFFEE BEAN; GOLDENSEAL; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 6; 6; 6; 6; 12; 6; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54973-3124_d8bf81d6-5e8e-4ced-90da-3711b94ab110 54973-3124 HUMAN OTC DRUG Defend Cold and Cough ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, and GOLDENSEAL LIQUID ORAL 20110617 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM SULFIDE; GOLDENSEAL; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM CHLORIDE; SULFUR 12; 6; 6; 12; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54973-3127_b1b45924-0383-4b09-b328-df16a86bcc5c 54973-3127 HUMAN OTC DRUG Baby Teething Calcium Phosphate, Chamomile, COFFEA ARABICA FRUIT, and Belladonna Leaf TABLET, SOLUBLE ORAL 20110711 UNAPPROVED HOMEOPATHIC Hyland's, Inc. BELLADONNA LEAF; CALCIUM PHOSPHATE; CHAMOMILE; COFFEA ARABICA FRUIT 12; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3134_a3c0876d-09b6-417e-8ffd-0de1372da9ea 54973-3134 HUMAN OTC DRUG DIARREX ARSENIC TRIOXIDE, PODOPHYLLUM, CHAMOMILE, PHOSPHORUS, and MERCURY TABLET ORAL 20120517 UNAPPROVED HOMEOPATHIC Hyland's ARSENIC TRIOXIDE; CHAMOMILE; MERCURY; PHOSPHORUS; PODOPHYLLUM 6; 6; 30; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3146_ea0532b1-9444-4dab-823e-6a5618e16afd 54973-3146 HUMAN OTC DRUG CALMS FORTE AVENA SATIVA FLOWERING TOP, CHAMOMILE, HUMULUS LUPULUS STEM, PASSIFLORA INCARNATA FLOWER, CALCIUM PHOSPHATE, FERROSOFERRIC PHOSPHATE, POTASSIUM PHOSPHATE, DIBASIC, SODIUM PHOSPHATE, and MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE TABLET ORAL 19601001 UNAPPROVED HOMEOPATHIC Hyland's AVENA SATIVA FLOWERING TOP; CALCIUM PHOSPHATE; CHAMOMILE; FERROSOFERRIC PHOSPHATE; HUMULUS LUPULUS STEM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PASSIFLORA INCARNATA FLOWER; POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE 1; 3; 2; 3; 1; 3; 1; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3147_c0451ad6-0c14-4837-858b-7597eafc5168 54973-3147 HUMAN OTC DRUG BABY COLIC DIOSCOREA VILLOSA TUBER, CHAMOMILE, and CITRULLUS COLOCYNTHIS FRUIT PULP TABLET, SOLUBLE ORAL 20121031 UNAPPROVED HOMEOPATHIC Hyland's CHAMOMILE; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3154_f566317e-75e3-44c7-8cbb-a9d5f8434efc 54973-3154 HUMAN OTC DRUG Cough Baby IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, and RUMEX CRISPUS ROOT SYRUP ORAL 20121017 UNAPPROVED HOMEOPATHIC Hyland's BRYONIA ALBA ROOT; CAUSTICUM; DROSERA ROTUNDIFOLIA; IPECAC; PHOSPHORUS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 6; 6; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54973-3155_967e06c7-2660-4bfe-bc68-4736cd62b6ec 54973-3155 HUMAN OTC DRUG NERVE TONIC STRESS RELIEF CALCIUM PHOSPHATE, IRON, POTASSIUM PHOSPHATE, UNSPECIFIED FORM, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, and SODIUM PHOSPHATE TABLET ORAL 19700101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM PHOSPHATE; IRON; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM PHOSPHATE, UNSPECIFIED FORM; SODIUM PHOSPHATE 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3156_482a99a3-5067-476e-8a2e-687fdce2162e 54973-3156 HUMAN OTC DRUG Defend Severe Cold and Flu ACONITUM NAPELLUS ROOT, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, and POTASSIUM IODIDE POWDER ORAL 20130401 UNAPPROVED HOMEOPATHIC Hyland's ACONITUM NAPELLUS ROOT; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 6; 6; 200; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3158_1c061831-6ba7-4e36-b337-708a50770953 54973-3158 HUMAN OTC DRUG Tiny Cold EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, and POTASSIUM IODIDE TABLET, SOLUBLE ORAL 20111228 UNAPPROVED HOMEOPATHIC Hyland's EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3160_52a83546-f998-46e9-a87f-8c800f71d7ae 54973-3160 HUMAN OTC DRUG SNIFFLES N SNEEZES 4 KIDS ACONITUM NAPELLUS ROOT, ONION, GELSEMIUM SEMPERVIRENS ROOT, and ZINC GLUCONATE TABLET ORAL 20130610 UNAPPROVED HOMEOPATHIC Hyland's ACONITUM NAPELLUS ROOT; GELSEMIUM SEMPERVIRENS ROOT; ONION; ZINC GLUCONATE 6; 6; 6; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3161_cbb1a581-5152-40fd-996a-0fdca5b39adc 54973-3161 HUMAN OTC DRUG CALM N RESTFUL 4 KIDS ACONITUM NAPELLUS ROOT, CALCIUM PHOSPHATE, CHAMOMILE, ARTEMISIA CINA PRE-FLOWERING TOP, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PULSATILLA VULGARIS, and SULFUR TABLET ORAL 20130610 UNAPPROVED HOMEOPATHIC Hyland's ACONITUM NAPELLUS ROOT; ARTEMISIA CINA PRE-FLOWERING TOP; CALCIUM PHOSPHATE; CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SODIUM CHLORIDE; SULFUR 6; 6; 12; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3162_e6d153d8-507c-4f79-aeb8-981ee3baba75 54973-3162 HUMAN OTC DRUG Restful Legs ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, and ZINC TABLET, SOLUBLE ORAL 20060717 UNAPPROVED HOMEOPATHIC Hyland's ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SULFUR; TOXICODENDRON PUBESCENS LEAF; ZINC 12; 6; 6; 6; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3163_04f403c3-100b-4d0d-b258-388142c2f007 54973-3163 HUMAN OTC DRUG ALLERGY RELIEF 4 KIDS ONION, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, and STRYCHNOS NUX-VOMICA SEED TABLET ORAL 20130610 UNAPPROVED HOMEOPATHIC Hyland's GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; ONION; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 12; 12; 12; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3164_748e4113-b2b1-47df-9e97-e7660712f528 54973-3164 HUMAN OTC DRUG COMPLETE COLD N FLU 4 KIDS ANAS PLATYRHYNCHOS FEATHER, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, and POTASSIUM IODATE TABLET ORAL 20130610 UNAPPROVED HOMEOPATHIC Hyland's ANAS PLATYRHYNCHOS FEATHER; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODATE 200; 3; 3; 3; 6; 3 [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3172_02b8219e-7ad6-4f7e-810f-b082b1a4abda 54973-3172 HUMAN OTC DRUG EARACHE DROPS BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, and SULFUR LIQUID AURICULAR (OTIC) 20040617 UNAPPROVED HOMEOPATHIC Hyland's ANEMONE PATENS; BELLADONNA LEAF; CALCIUM CARBONATE; CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; SULFUR 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 54973-3174_7a28fdcf-2057-4357-bef2-34619df257c8 54973-3174 HUMAN OTC DRUG BABY GAS DROPS SILVER NITRATE, FERULA SUMBUL ROOT, ACTIVATED CHARCOAL, CHAMOMILE, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT, LYCOPODIUM CLAVATUM SPORE, NUTMEG, and SEPIA OFFICINALIS JUICE LIQUID ORAL 20140115 UNAPPROVED HOMEOPATHIC Hyland's ACTIVATED CHARCOAL; CHAMOMILE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT; FERULA SUMBUL ROOT; LYCOPODIUM CLAVATUM SPORE; NUTMEG; SEPIA OFFICINALIS JUICE; SILVER NITRATE 12; 6; 6; 6; 6; 30; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54973-3177_fc79f24e-1c6f-4c33-9f58-498a698ff5a0 54973-3177 HUMAN OTC DRUG 4 Kids Cold n Cough Day and Night Value Pack ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, GOLDENSEAL, STRYCHNOS NUX-VOMICA SEED, COFFEE BEAN, and CHAMOMILE KIT 20131201 UNAPPROVED HOMEOPATHIC Hylands Inc. 54973-3179_41f8b03a-6298-460d-8533-a313939e2440 54973-3179 HUMAN OTC DRUG 4 Kids Complete Cold and Mucus BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, RUMEX CRISPUS ROOT, and SILICON DIOXIDE LIQUID ORAL 20140701 UNAPPROVED HOMEOPATHIC Hyland's BRYONIA ALBA ROOT; CALCIUM SULFIDE; EUPHRASIA STRICTA; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SILICON DIOXIDE; SODIUM CHLORIDE 6; 12; 6; 30; 6; 6; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54973-3180_3ed82e8d-d144-4659-b8b7-a3cd9d63e06b 54973-3180 HUMAN OTC DRUG Baby Nighttime Tiny Cold CHAMOMILE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, and Potassium Iodide LIQUID ORAL 20140701 UNAPPROVED HOMEOPATHIC Hyland's CHAMOMILE; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54973-3183_89b70071-4853-4835-8d03-c05d69250b95 54973-3183 HUMAN OTC DRUG Defend Cold and Mucus BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, and SILICON DIOXIDE LIQUID ORAL 20140701 UNAPPROVED HOMEOPATHIC Hyland's ANEMONE PATENS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; EUPHRASIA STRICTA; PHOSPHORUS; RUMEX CRISPUS ROOT; SILICON DIOXIDE; SODIUM CHLORIDE 6; 6; 12; 6; 30; 6; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54973-3185_f5c64dcf-82cf-481e-a791-4133a677fe50 54973-3185 HUMAN OTC DRUG DEFEND Cough BRYONIA ALBA ROOT, CAUSTICUM, DROSERA ROTUNDIFOLIA, IPECAC, PHOSPHORUS, RUMEX CRISPUS ROOT, and SPONGIA OFFICINALIS SKELETON, ROASTED SYRUP ORAL 20140701 UNAPPROVED HOMEOPATHIC Hyland's BRYONIA ALBA ROOT; CAUSTICUM; DROSERA ROTUNDIFOLIA; IPECAC; PHOSPHORUS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 6; 6; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54973-3186_93cc94b2-f774-4da7-84f6-973b3f4416b9 54973-3186 HUMAN OTC DRUG 4 Kids Complete Cold and Flu ANAS PLATYRHYNCHOS FEATHER, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, and Potassium Iodide LIQUID ORAL 20140414 UNAPPROVED HOMEOPATHIC Hyland's ANAS PLATYRHYNCHOS FEATHER; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 200; 6; 6; 6; 6; 6 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54973-3187_dc7bd318-ec85-4c30-8050-0302fc7c4d07 54973-3187 HUMAN OTC DRUG DEFEND Sinus OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, and PULSATILLA VULGARIS TABLET, SOLUBLE ORAL 20140701 UNAPPROVED HOMEOPATHIC Hyland's GOLDENSEAL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS 6; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3188_5d563268-c697-4ae3-9edc-1eb9d30556e3 54973-3188 HUMAN OTC DRUG Sinus OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, and PULSATILLA VULGARIS TABLET ORAL 20140801 UNAPPROVED HOMEOPATHIC Hyland's GOLDENSEAL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS 6; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3195_e5ae3b4c-b33b-4a65-986b-2572560168ad 54973-3195 HUMAN OTC DRUG CALMING MATRICARIA RECUTITA, ARABICA COFFEE BEAN, STRYCHNOS IGNATII SEED, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PLATINUM, PULSATILLA VULGARIS, DATURA STRAMONIUM, and SULFUR TABLET ORAL 20140919 UNAPPROVED HOMEOPATHIC Hyland's ARABICA COFFEE BEAN; DATURA STRAMONIUM; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PLATINUM; PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; SULFUR 6; 6; 30; 6; 30; 6; 6; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3196_995b0e40-ff4a-4c26-b5a8-1dd82b31ddb1 54973-3196 HUMAN OTC DRUG Tummy Ache 4Kids SILVER NITRATE, ASAFETIDA, ACTIVATED CHARCOAL, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, CITRULLUS COLOCYNTHIS FRUIT PULP, LYCOPODIUM CLAVATUM SPORE, NUTMEG, and PULSATILLA VULGARIS TABLET ORAL 20141020 UNAPPROVED HOMEOPATHIC Hyland's ACTIVATED CHARCOAL; ASAFETIDA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; NUTMEG; PULSATILLA VULGARIS; SILVER NITRATE 12; 6; 6; 6; 30; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3197_71240751-ff0c-4489-af97-4df3d1e96564 54973-3197 HUMAN OTC DRUG NIGHTTIME TEETHING TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, ARABICA COFFEE BEAN, ATROPA BELLADONNA, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SILICON DIOXIDE, and RHEUM OFFICINALE ROOT TABLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Hyland's ARABICA COFFEE BEAN; ATROPA BELLADONNA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; RHEUM OFFICINALE ROOT; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6; 6; 12; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3206_82080ce0-b30b-4dd8-bf0b-536e81c83f61 54973-3206 HUMAN OTC DRUG Sleep HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, and POTASSIUM PHOSPHATE, DIBASIC TABLET ORAL 20141105 UNAPPROVED HOMEOPATHIC Hyland's HYOSCYAMUS NIGER; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS IGNATII SEED 6; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3223_68f8dcf2-b0a1-408b-bfb9-6479302c5bad 54973-3223 HUMAN OTC DRUG EnurAid ATROPA BELLADONNA, LYTTA VESICATORIA, APIS MELLIFERA, ARNICA MONTANA, ONION, RHUS AROMATICA ROOT BARK, and EQUISETUM HYEMALE TABLET, SOLUBLE ORAL 19990101 UNAPPROVED HOMEOPATHIC Hyland's APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; EQUISETUM HYEMALE; LYTTA VESICATORIA; ONION; RHUS AROMATICA ROOT BARK 6; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-3431_5e6cb803-a19e-4332-a400-f8355f0ce5ce 54973-3431 HUMAN OTC DRUG FERRUM PHOSPHATE SODIUM PHOSPHATE TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's SODIUM PHOSPHATE 6 [hp_X]/1 54973-5224_5f4012d0-6dd6-4702-a5bc-43839694828b 54973-5224 HUMAN OTC DRUG KALI MURIATICUM POTASSIUM CHLORIDE TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's POTASSIUM CHLORIDE 6 [hp_X]/1 54973-5228_707c981e-6613-4ad2-ab64-7193b29c5a21 54973-5228 HUMAN OTC DRUG KALI PHOS POTASSIUM PHOSPHATE, UNSPECIFIED FORM TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's POTASSIUM PHOSPHATE, UNSPECIFIED FORM 6 [hp_X]/1 54973-5230_cad9c99e-3908-43b0-a3a6-bc2eafb7ee75 54973-5230 HUMAN OTC DRUG KALI SULPH POTASSIUM SULFATE TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's POTASSIUM SULFATE 6 [hp_X]/1 54973-6020_2b9c425f-77a3-4bce-a59d-7559bd88e457 54973-6020 HUMAN OTC DRUG MAGNESIA PHOS MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE TABLET ORAL 19600101 UNAPPROVED HOMEOPATHIC Hyland's MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X]/1 54973-6433_8a3c75fa-45a4-436b-b4f3-df9f7beef984 54973-6433 HUMAN OTC DRUG NATRUM MURIATICUM SODIUM CHLORIDE TABLET ORAL 19600101 UNAPPROVED HOMEOPATHIC Hyland's SODIUM CHLORIDE 6 [hp_X]/1 54973-6436_500ee600-f8a3-4339-b4ee-a94d45f44ea3 54973-6436 HUMAN OTC DRUG NAT. PHOS. SODIUM PHOSPHATE, DIBASIC, ANHYDROUS TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 6 [hp_X]/1 54973-6440_989a438e-2783-4bea-870e-c808b091658b 54973-6440 HUMAN OTC DRUG NAT SULPH SODIUM SULFATE ANHYDROUS TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's SODIUM SULFATE ANHYDROUS 6 [hp_X]/1 54973-7505_d0462cc0-dbc0-42b5-b907-e801c6dc617f 54973-7505 HUMAN OTC DRUG C-Plus EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, and POTASSIUM IODIDE TABLET, SOLUBLE ORAL 19300101 UNAPPROVED HOMEOPATHIC Hyland's EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 3; 2; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-7507_34cff91e-b60b-49a5-aebd-73c4db50b02f 54973-7507 HUMAN OTC DRUG EARACHE BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA PATENS, and SULFUR TABLET ORAL 19990101 UNAPPROVED HOMEOPATHIC Hyland's BELLADONNA LEAF; CALCIUM CARBONATE; CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA PATENS; SULFUR 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 54973-7508_e36f989a-921b-47d4-aea3-25b09afbd087 54973-7508 HUMAN OTC DRUG Bumps n Bruises with Arnica ARNICA MONTANA, HYPERICUM PERFORATUM, BELLIS PERENNIS, and RUTA GRAVEOLENS FLOWERING TOP TABLET, SOLUBLE ORAL 20061214 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-7509_c3d448c2-c701-4971-95ec-70b4182c48b0 54973-7509 HUMAN OTC DRUG BABY DIAPER CALENDULA OFFICINALIS FLOWER OINTMENT TOPICAL 20010101 UNAPPROVED HOMEOPATHIC Hyland's CALENDULA OFFICINALIS FLOWER 1 [hp_X]/g 54973-7510_ed71fd35-9505-4f1e-a807-ebf844245919 54973-7510 HUMAN OTC DRUG BUMPS N BRUISES ARNICA MONTANA ROOT OINTMENT TOPICAL 20011018 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA ROOT 1 [hp_X]/8g 54973-7511_4a66c98f-32c0-49e9-a1bf-29754e0cff1d 54973-7511 HUMAN OTC DRUG Bug Bite APIS MELLIFERA, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA ROOT, LEDUM PALUSTRE TWIG, and URTICA DIOICA OINTMENT TOPICAL 19900101 UNAPPROVED HOMEOPATHIC Hyland's APIS MELLIFERA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA ROOT; LEDUM PALUSTRE TWIG; URTICA DIOICA 3; 3; 3; 3; 3 [hp_X]/8g; [hp_X]/8g; [hp_X]/8g; [hp_X]/8g; [hp_X]/8g 54973-7514_fa33c812-2086-4a19-8a85-a9214cab2c67 54973-7514 HUMAN OTC DRUG Leg Cramps ACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, and VISCUM ALBUM FRUITING TOP OINTMENT TOPICAL 20030918 UNAPPROVED HOMEOPATHIC Hyland's ACONITUM NAPELLUS; ARNICA MONTANA; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP 3; 3; 3; 10; 6; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 54973-7516_02568eff-80f3-4b3a-a05a-bf54546b5c80 54973-7516 HUMAN OTC DRUG BABY INFANT EARACHE DROPS ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, and SULFUR LIQUID AURICULAR (OTIC) 20040316 UNAPPROVED HOMEOPATHIC Hyland's ATROPA BELLADONNA; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SULFUR 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 54973-7520_1b052210-5c0f-47a1-8a06-f8d62b5505b7 54973-7520 HUMAN OTC DRUG Cough with 100% Natural Honey 4 Kids IPECAC, ACONITUM NAPELLUS, SPONGIA OFFICINALIS SKELETON, ROASTED, and ANTIMONY POTASSIUM TARTRATE SYRUP ORAL 20080801 UNAPPROVED HOMEOPATHIC Hylands Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; IPECAC; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54973-7521_d92c2e5b-9048-462c-b2db-73329ba83918 54973-7521 HUMAN OTC DRUG Teething TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, ARABICA COFFEE BEAN, and ATROPA BELLADONNA GEL ORAL 20090417 UNAPPROVED HOMEOPATHIC Hyland's ARABICA COFFEE BEAN; ATROPA BELLADONNA; MATRICARIA RECUTITA; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 54973-8081_324f40b3-2e53-4532-8902-a2b713eb2601 54973-8081 HUMAN OTC DRUG SILICEA SILICON DIOXIDE TABLET ORAL 19600101 UNAPPROVED HOMEOPATHIC Hyland's SILICON DIOXIDE 6 [hp_X]/1 54973-9104_ddaac1e1-a325-4717-b5e6-40f4f8ad5d8a 54973-9104 HUMAN OTC DRUG Cough BRYONIA ALBA ROOT, CAUSTICUM, CALCIUM SULFIDE, and ANTIMONY POTASSIUM TARTRATE TABLET, SOLUBLE ORAL 19940809 UNAPPROVED HOMEOPATHIC Hyland's ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAUSTICUM 6; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-9113_72629595-5e70-499e-b794-106d6b9833ef 54973-9113 HUMAN OTC DRUG Menopause AMYL NITRITE, SANGUINARIA CANADENSIS ROOT, and LACHESIS MUTA VENOM TABLET, SOLUBLE ORAL 19950301 UNAPPROVED HOMEOPATHIC Hyland's AMYL NITRITE; LACHESIS MUTA VENOM; SANGUINARIA CANADENSIS ROOT 6; 12; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-9120_24e9e2c0-e73d-4bca-bdfd-90432ab25161 54973-9120 HUMAN OTC DRUG Sore Throat BELLADONNA LEAF, PHYTOLACCA AMERICANA ROOT, BARIUM CARBONATE, and MERCURIC IODIDE TABLET, SOLUBLE ORAL 19970828 UNAPPROVED HOMEOPATHIC Hyland's BARIUM CARBONATE; BELLADONNA LEAF; MERCURIC IODIDE; PHYTOLACCA AMERICANA ROOT 6; 3; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-9123_e3ae7444-2f4c-45fe-b932-3fba6e73c7dc 54973-9123 HUMAN OTC DRUG INSOMNIA HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, and POTASSIUM PHOSPHATE, DIBASIC TABLET, SOLUBLE ORAL 19940301 UNAPPROVED HOMEOPATHIC Hyland's HYOSCYAMUS NIGER; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS IGNATII SEED 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-9127_0afe6491-2ae7-4805-a374-4ae7b9f70fd7 54973-9127 HUMAN OTC DRUG COLD SORES AND FEVER BLISTERS SODIUM BORATE, ANTIMONY TRISULFIDE, BAPTISIA TINCTORIA ROOT, and SODIUM CHLORIDE TABLET, SOLUBLE ORAL 19970527 UNAPPROVED HOMEOPATHIC Hyland's ANTIMONY TRISULFIDE; BAPTISIA TINCTORIA ROOT; SODIUM BORATE; SODIUM CHLORIDE 3; 3; 2; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-9130_ef37d9ca-4d14-4e84-befd-9405697ad2c6 54973-9130 HUMAN OTC DRUG Hemorrhoids HORSE CHESTNUT, KRAMERIA LAPPACEA ROOT, STRYCHNOS NUX-VOMICA SEED, and CALCIUM FLUORIDE TABLET, SOLUBLE ORAL 19990915 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM FLUORIDE; HORSE CHESTNUT; KRAMERIA LAPPACEA ROOT; STRYCHNOS NUX-VOMICA SEED 6; 1; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-9138_55bb3eff-1a62-43fa-baa5-5bf49023343e 54973-9138 HUMAN OTC DRUG Hayfever AMBROSIA ARTEMISIIFOLIA, EUPHRASIA STRICTA, ONION, and SCHOENOCAULON OFFICINALE SEED TABLET, SOLUBLE ORAL 19970527 UNAPPROVED HOMEOPATHIC Hyland's AMBROSIA ARTEMISIIFOLIA; EUPHRASIA STRICTA; ONION; SCHOENOCAULON OFFICINALE SEED 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-9146_b7d71cb2-7fdc-403f-88f5-d3da86126169 54973-9146 HUMAN OTC DRUG Hives APIS MELLIFERA, URTICA URENS, SODIUM CHLORIDE, and ARSENIC TRIOXIDE TABLET, SOLUBLE ORAL 19970527 UNAPPROVED HOMEOPATHIC Hyland's APIS MELLIFERA; ARSENIC TRIOXIDE; SODIUM CHLORIDE; URTICA URENS 3; 6; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-9147_28db30c9-23b5-4301-ac23-459d5e442648 54973-9147 HUMAN OTC DRUG Motion Sickness STRYCHNOS NUX-VOMICA SEED, TOBACCO LEAF, KEROSENE, and ANAMIRTA COCCULUS SEED TABLET, SOLUBLE ORAL 19941201 UNAPPROVED HOMEOPATHIC Hyland's ANAMIRTA COCCULUS SEED; KEROSENE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 30; 12; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 54973-9150_323b2303-8a6e-4c46-a1e3-d51b174fac3d 54973-9150 HUMAN OTC DRUG UPSET STOMACH STRYCHNOS NUX-VOMICA SEED and ACTIVATED CHARCOAL TABLET ORAL 19900101 UNAPPROVED HOMEOPATHIC Hyland's ACTIVATED CHARCOAL; STRYCHNOS NUX-VOMICA SEED 3; 3 [hp_X]/1; [hp_X]/1 54982-0001_d3f2cd42-a1b6-4f65-998e-b934fdd5ac20 54982-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020125 UNAPPROVED MEDICAL GAS RTA Homecare, Inc. OXYGEN 99 L/100L 54997-186_205eb5fd-078d-4355-b9de-31c5f4b09054 54997-186 HUMAN OTC DRUG 4Life Enummi Protective Day Moisturizer SPF-15 Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20070801 OTC MONOGRAPH NOT FINAL part352 4Life Research USA, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 2 g/100mL; g/100mL; g/100mL 55037-101_a8844d3b-2524-4ac6-959c-045ff93a96a6 55037-101 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19870101 NDA NDA205889 Matheson Tri-Gas, Inc. OXYGEN 992 1/L 55037-201_29d72131-5415-4c78-bb65-08c4a1d657e2 55037-201 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19870101 NDA NDA205891 Matheson Tri-Gas, Inc. NITROGEN 992 mL/L 55037-301_2656484e-f861-4a97-be3c-1ebe8dccd293 55037-301 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19870101 UNAPPROVED MEDICAL GAS Matheson Tri-Gas, Inc. NITROUS OXIDE 992 mL/L 55037-302_5f96004e-257b-47c7-b988-49e1c2fb3887 55037-302 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19870101 NDA NDA205890 Matheson Tri-Gas, Inc. AIR 1000 mL/L 55037-401_3abcfdc2-7187-47cc-8cd0-3666c00d1dc4 55037-401 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19870101 UNAPPROVED MEDICAL GAS Matheson Tri-Gas, Inc. CARBON DIOXIDE 992 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 55037-501_6f69739b-88c1-4d42-8bc0-05e4064b3ba1 55037-501 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19870101 UNAPPROVED MEDICAL GAS Matheson Tri-Gas, Inc. HELIUM 992 mL/L 55038-001_3aa0b050-14ac-4b1a-9f27-5dd04af71706 55038-001 HUMAN OTC DRUG POMADA DRAGON PAIN RELIEVING CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20120731 OTC MONOGRAPH NOT FINAL part348 TELEVISA CONSUMER PRODUCTS USA CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g 55038-002_c67a0356-7f0e-4060-8c7f-8db6df7a8a36 55038-002 HUMAN OTC DRUG OPTICAL ADVANCED EYE DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL SOLUTION/ DROPS OPHTHALMIC 20121031 OTC MONOGRAPH FINAL part349 TELEVISA CONSUMER PRODUCTS USA DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL 55038-023_5c818ba9-0c7a-45c4-8891-d3f4f565f6f6 55038-023 HUMAN OTC DRUG OPTICAL ORIGINAL EYE DROPS TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20121031 OTC MONOGRAPH FINAL part349 TELEVISA CONSUMER PRODUCTS USA TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 55038-444_e5169895-2790-474a-baa8-fb211b211c65 55038-444 HUMAN OTC DRUG Asepxia SALICYLIC ACID GEL TOPICAL 20110817 OTC MONOGRAPH FINAL part333D Televisa Consumer Products USA SALICYLIC ACID 2 g/100g 55038-555_6501d8ea-99a9-48e2-86f9-28f2ac43c748 55038-555 HUMAN OTC DRUG Asepxia SALICYLIC ACID LOTION TOPICAL 20110817 OTC MONOGRAPH FINAL part333D Televisa Consumer Products USA SALICYLIC ACID 18.6 mg/mL 55045-1147_cca757b4-55c2-4d0f-b578-e4d658c6db2f 55045-1147 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate gentamicin sulfate CREAM TOPICAL 19840705 ANDA ANDA062531 Dispensing Solutions, Inc. GENTAMICIN SULFATE 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 55045-1167_37aaa55b-70dd-43fe-b026-757c8f8c3fdb 55045-1167 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Dispensing Solutions, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55045-1173_65fc9178-778e-43b0-9ef0-471dec4d16e1 55045-1173 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Dispensing Solutions, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55045-1194_07080003-b495-447a-bb9d-0efbe866e37a 55045-1194 HUMAN PRESCRIPTION DRUG NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN neomycin sulfate, polymyxin b sulfate and gramicidin SOLUTION/ DROPS OPHTHALMIC 19960131 ANDA ANDA064047 Dispensing Solutions, Inc. GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE .025; 1.75; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 55045-1243_e0f01554-43e3-4ed2-afef-d9fa4f539e54 55045-1243 HUMAN PRESCRIPTION DRUG acetic acid acetic acid SOLUTION AURICULAR (OTIC) 20100122 NDA NDA012179 Dispensing Solutions, Inc. ACETIC ACID 20.65 mg/mL 55045-1259_93aefabb-b384-40ef-9d3f-f8dee3b21f1c 55045-1259 HUMAN PRESCRIPTION DRUG MethylPREDNISolone methylprednisolone TABLET ORAL 19981222 ANDA ANDA040183 Dispensing Solutions, Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55045-1266_e3562eaf-3ea6-4b11-903d-43479c7a1f1a 55045-1266 HUMAN PRESCRIPTION DRUG Promethazine VC With Codeine Codeine Phosphate, Promethazine Hydrochloride, and Phenylephrine Hydrochloride SYRUP ORAL 20061207 ANDA ANDA040660 Dispensing Solutions, Inc. CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10; 5; 6.5 mg/5mL; mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] CV 55045-1350_ed20915d-9b52-41e3-9ecd-8ebe6073c149 55045-1350 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19960718 ANDA ANDA064030 Dispensing Solutions, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55045-1433_667d0cdd-ff0b-45fa-a089-d7f563bbbda8 55045-1433 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 Dispensing Solutions, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 55045-1495_34c0ab0b-2de8-4be7-a600-a7fb67e08b9b 55045-1495 HUMAN OTC DRUG Cheratussin AC codeine phosphate and guaifenesin LIQUID ORAL 19960901 OTC MONOGRAPH FINAL part341 Dispensing Solutions, Inc. CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 55045-1580_916a131e-f470-4b42-b99d-9fb42e777a96 55045-1580 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 Dispensing Solutions, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 CIII 55045-1594_d223d18e-6d76-4a00-8c63-6ee0be2110bc 55045-1594 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110116 ANDA ANDA089895 Dispensing Solutions, Inc. CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55045-1643_a720b953-0e63-4338-9a7f-ecf7b2784446 55045-1643 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SYRUP ORAL 20060426 ANDA ANDA040643 Dispensing Solutions, Inc. PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55045-1715_1531bc94-6955-4325-b76d-c8fbeeab70a3 55045-1715 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110120 ANDA ANDA071523 Dispensing Solutions, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 55045-1755_25095d93-158f-4fe1-972d-db7f8bc6d6e1 55045-1755 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION OPHTHALMIC 20040701 ANDA ANDA088771 Dispensing Solutions, Inc. DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55045-2092_7ebf0c69-ebc7-4ec0-a6c7-6b64880add9d 55045-2092 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20110504 ANDA ANDA086030 Dispensing Solutions, Inc. TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 55045-2386_a2bee0b5-a65e-4b4a-abce-60425cef53cc 55045-2386 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19960222 ANDA ANDA040143 Dispensing Solutions, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55045-2759_6493c29c-1bba-4172-badb-ea5cb3d9e727 55045-2759 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 19991027 NDA NDA021087 Dispensing Solutions, Inc. OSELTAMIVIR PHOSPHATE 75 mg/1 Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] 55045-2992_f3071984-c98d-464e-9211-08ac1600970e 55045-2992 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20090601 ANDA ANDA065334 Dispensing Solutions Inc. AMOXICILLIN 400 mg/5mL 55045-3143_20baf571-544d-4945-b3dc-b905a54ec7bd 55045-3143 HUMAN OTC DRUG MUCINEX GUAIFENESIN TABLET, EXTENDED RELEASE ORAL 20100512 NDA NDA021282 Dispensing Solutions, Inc. GUAIFENESIN 600 mg/1 55045-3197_bab06ccd-d2f7-419b-8352-e3b038223578 55045-3197 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE OCCLUSIVE DRESSING TECHNIQUE 20090702 ANDA ANDA079095 Dispensing Solutions, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 55045-3198_6493c29c-1bba-4172-badb-ea5cb3d9e727 55045-3198 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate POWDER, FOR SUSPENSION ORAL 20001214 NDA NDA021246 Dispensing Solutions, Inc. OSELTAMIVIR PHOSPHATE 12 mg/mL Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] 55045-3207_f72addbb-85a1-4830-b6db-c2e964b03385 55045-3207 HUMAN PRESCRIPTION DRUG EpiPen Epinephrine INJECTION INTRAMUSCULAR 19871222 NDA NDA019430 Dispensing Solutions, Inc. EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55045-3243_257ca1c6-80d4-478d-8d5b-f6a002c55983 55045-3243 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Dispensing Solutions, Inc. METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55045-3248_e191c79d-3f8d-43fb-b10c-73eb5c150b02 55045-3248 HUMAN PRESCRIPTION DRUG KENALOG-40 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 20090601 NDA NDA014901 Dispensing Solutions, Inc. TRIAMCINOLONE ACETONIDE 40 mg/mL 55045-3259_bce76198-3fdc-482e-8c03-31fd4e134aeb 55045-3259 HUMAN PRESCRIPTION DRUG TERCONAZOLE terconazole CREAM VAGINAL 20040401 NDA NDA019964 Dispensing Solutions, Inc. TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 55045-3453_683a963a-2436-4330-85cf-29c6b255cb25 55045-3453 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Dispensing Solutions, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55045-3598_e49b84de-9d18-439a-8c09-fdb24ba0179a 55045-3598 HUMAN PRESCRIPTION DRUG EpiPen Jr Epinephrine INJECTION INTRAMUSCULAR 19871222 NDA NDA019430 Dispensing Solutions, Inc. EPINEPHRINE .15 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55045-3602_0b67b87e-09b2-4469-846e-52ea3f962018 55045-3602 HUMAN PRESCRIPTION DRUG Humalog Insulin lispro INJECTION, SOLUTION SUBCUTANEOUS 19960724 NDA NDA020563 Dispensing Solutions, Inc. INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 55045-3683_c1d3f51d-5d58-4d4e-9f7c-81e0734822b2 55045-3683 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19721127 ANDA ANDA080817 Dispensing Solutions, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 55045-3685_71907ed5-ee95-471a-8d7d-f72dcbbdfb60 55045-3685 HUMAN PRESCRIPTION DRUG Lantus insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20090923 NDA NDA021081 Dispensing Solutions, Inc. INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 55045-3691_733ba226-4bba-4b0d-9bba-ec404e3c5977 55045-3691 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin CREAM TOPICAL 19981224 ANDA ANDA075213 Dispensing Solutions, Inc. TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 55045-3693_beed0095-b4a2-4a71-b484-f27325bc899a 55045-3693 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065405 Dispensing Solutions, Inc. AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55045-3729_e75fe627-6f74-4e14-8b7e-0b360ebaee22 55045-3729 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Dispensing Solutions, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55045-3817_e75fe627-6f74-4e14-8b7e-0b360ebaee22 55045-3817 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Dispensing Solutions, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55045-3841_25851d21-e9bb-458f-a820-25f5d01ee97d 55045-3841 VACCINE HAVRIX Hepatitis A Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20070413 BLA BLA103475 Dispensing Solutions, Inc. HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 1440 [iU]/mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 55045-3848_96dae489-ae80-4953-8d9a-df682794cbdf 55045-3848 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Dispensing Solutions, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55050-0001_7e84fa10-b99a-4bc0-86d7-a69c8fa96b0e 55050-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19580101 UNAPPROVED MEDICAL GAS Holston Gases, Inc OXYGEN 99 L/100L 55050-0006_57d22531-726e-431a-b05c-2f9d61a7adc2 55050-0006 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19580101 UNAPPROVED MEDICAL GAS Holston Gases, Inc NITROGEN 99 L/100L 55050-0008_8f26ed93-327d-468a-ac00-c11e6aab2027 55050-0008 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19580101 UNAPPROVED MEDICAL GAS Holston Gases, Inc NITROUS OXIDE 99 kg/100kg 55050-0011_c8f2789f-ccbf-4347-b340-c2e3ff6d872b 55050-0011 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19580101 NDA NDA205849 Holston Gases, Inc OXYGEN 99 L/100L 55050-0016_b1932ade-4225-4036-9c1f-10a9399e7fea 55050-0016 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19580101 NDA NDA205850 Holston Gases, Inc NITROGEN 99 L/100L 55050-0018_0ad91452-a8a5-4c1e-bd66-c2b63c0c2116 55050-0018 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19580101 NDA NDA206009 Holston Gases, Inc NITROUS OXIDE 99 kg/100kg 55056-0406_6ea8a930-2eae-435e-b13c-f2c9e9a4bf00 55056-0406 HUMAN PRESCRIPTION DRUG Prochieve progesterone GEL VAGINAL 19970513 NDA NDA020701 Columbia Laboratories PROGESTERONE 45 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] 55056-0806_f2c9bbef-22b9-413b-930d-e84fbea8247b 55056-0806 HUMAN PRESCRIPTION DRUG Crinone progesterone GEL VAGINAL 19970513 NDA NDA020701 Columbia Laboratories, Inc. PROGESTERONE 90 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] 55056-0808_f2c9bbef-22b9-413b-930d-e84fbea8247b 55056-0808 HUMAN PRESCRIPTION DRUG Crinone progesterone GEL VAGINAL 19970513 NDA NDA020701 Columbia Laboratories, Inc. PROGESTERONE 45 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] 55056-0818_f2c9bbef-22b9-413b-930d-e84fbea8247b 55056-0818 HUMAN PRESCRIPTION DRUG Crinone progesterone GEL VAGINAL 19970513 NDA NDA020701 Columbia Laboratories, Inc. PROGESTERONE 90 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] 55056-1601_6ea8a930-2eae-435e-b13c-f2c9e9a4bf00 55056-1601 HUMAN PRESCRIPTION DRUG Prochieve progesterone GEL VAGINAL 19970513 NDA NDA020701 Columbia Laboratories PROGESTERONE 90 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] 55056-3060_b6cd73a8-8abb-4be4-9174-7215c1096287 55056-3060 HUMAN PRESCRIPTION DRUG Striant testosterone TABLET BUCCAL 20030619 NDA NDA021543 Columbia Laboratories, Inc. TESTOSTERONE 30 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 55071-001_0299d45c-b5e7-4391-bf59-b98ec0ace84d 55071-001 HUMAN OTC DRUG SUN SAVVY SOLAR SHIELD SPF 20 ZINC OXIDE TITANIUM DIOXIDE LOTION TOPICAL 20110326 OTC MONOGRAPH NOT FINAL part352 APPLIED SKIN TECHNOLOGY LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 5 g/100mL; g/100mL 55111-112_25780078-e892-fc74-fb92-305525dcc89c 55111-112 HUMAN PRESCRIPTION DRUG Moxifloxacin Moxifloxacin TABLET, FILM COATED ORAL 20140305 ANDA ANDA076938 Dr. Reddy's Laboratories Limited MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55111-118_96630fbf-75a9-3a2e-1069-e8c0b5505136 55111-118 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20060930 ANDA ANDA077367 Dr.Reddys Laboratories Limited FAMOTIDINE 10 mg/1 55111-119_41dccadc-e17f-ecba-69ea-bba59bff13ce 55111-119 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075718 Dr.Reddy's Laboratories Limited FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55111-120_41dccadc-e17f-ecba-69ea-bba59bff13ce 55111-120 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075718 Dr.Reddy's Laboratories Limited FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55111-121_6bbf3916-7a00-1334-85c9-575949dff2f2 55111-121 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20120717 ANDA ANDA091650 Dr. Reddy's Laboratories Limited ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55111-122_6bbf3916-7a00-1334-85c9-575949dff2f2 55111-122 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20120717 ANDA ANDA091650 Dr. Reddy's Laboratories Limited ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55111-123_6bbf3916-7a00-1334-85c9-575949dff2f2 55111-123 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20120717 ANDA ANDA091650 Dr. Reddy's Laboratories Limited ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55111-124_42634c8f-8820-4c36-2d38-2c74bd6f3f77 55111-124 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20120717 ANDA ANDA202357 Dr. Reddy's Laboratories Limited ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55111-125_570c6953-aee1-31d9-7dcb-94b0dbf4cbf6 55111-125 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Dr Reddy's Laboratories CIPROFLOXACIN HYDROCHLORIDE 100 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55111-126_570c6953-aee1-31d9-7dcb-94b0dbf4cbf6 55111-126 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Dr Reddy's Laboratories CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55111-127_570c6953-aee1-31d9-7dcb-94b0dbf4cbf6 55111-127 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Dr Reddy's Laboratories CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55111-128_570c6953-aee1-31d9-7dcb-94b0dbf4cbf6 55111-128 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Dr Reddy's Laboratories CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55111-129_31dc8e01-6764-d9b7-431e-62b328924f55 55111-129 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride CAPSULE ORAL 20010112 ANDA ANDA075742 Dr. Reddy's Laboratories Limited RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55111-130_31dc8e01-6764-d9b7-431e-62b328924f55 55111-130 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride CAPSULE ORAL 20010401 ANDA ANDA075742 Dr. Reddy's Laboratories Limited RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55111-131_109515ea-3048-acd0-bfbd-e083489525a2 55111-131 HUMAN OTC DRUG Ranitidine Ranitidine TABLET ORAL 20000301 ANDA ANDA075294 Dr. Reddy's Laboratories Limited RANITIDINE HYDROCHLORIDE 75 mg/1 55111-133_5629752d-3fed-ff51-690a-9efe0e400d82 55111-133 HUMAN PRESCRIPTION DRUG Enalapril maleate and hydrochlorothiazide Enalapril maleate and hydrochlorothiazide TABLET ORAL 20011015 ANDA ANDA075909 Dr. Reddy's Laboratories Limited ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 5; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55111-134_5629752d-3fed-ff51-690a-9efe0e400d82 55111-134 HUMAN PRESCRIPTION DRUG Enalapril maleate and hydrochlorothiazide Enalapril maleate and hydrochlorothiazide TABLET ORAL 20011015 ANDA ANDA075909 Dr. Reddy's Laboratories Limited ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55111-135_98ae4863-dbf6-e738-b1a0-8f7a620cd0d3 55111-135 HUMAN PRESCRIPTION DRUG ZENATANE ISOTRETINOIN CAPSULE, GELATIN COATED ORAL 20130326 ANDA ANDA202099 Dr. Reddy's Laboratories Limited ISOTRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 55111-136_98ae4863-dbf6-e738-b1a0-8f7a620cd0d3 55111-136 HUMAN PRESCRIPTION DRUG ZENATANE ISOTRETINOIN CAPSULE, GELATIN COATED ORAL 20130326 ANDA ANDA202099 Dr. Reddy's Laboratories Limited ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 55111-137_98ae4863-dbf6-e738-b1a0-8f7a620cd0d3 55111-137 HUMAN PRESCRIPTION DRUG ZENATANE ISOTRETINOIN CAPSULE, GELATIN COATED ORAL 20130326 ANDA ANDA202099 Dr. Reddy's Laboratories Limited ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 55111-143_911d9274-cbf2-9e14-b01d-eba490787ed7 55111-143 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140620 ANDA ANDA076658 Dr. Reddy's Laboratories Limited FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55111-144_911d9274-cbf2-9e14-b01d-eba490787ed7 55111-144 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140620 ANDA ANDA076658 Dr. Reddy's Laboratories Limited FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55111-145_911d9274-cbf2-9e14-b01d-eba490787ed7 55111-145 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140620 ANDA ANDA076658 Dr. Reddy's Laboratories Limited FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55111-146_911d9274-cbf2-9e14-b01d-eba490787ed7 55111-146 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140620 ANDA ANDA076658 Dr. Reddy's Laboratories Limited FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55111-147_ecbf7c9a-2190-d50e-d23b-8f9c6a010ebc 55111-147 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20021015 ANDA ANDA075465 Dr.Reddy's Laboratories Limited FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-148_ecbf7c9a-2190-d50e-d23b-8f9c6a010ebc 55111-148 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20021015 ANDA ANDA075465 Dr.Reddy's Laboratories Limited FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-149_ecbf7c9a-2190-d50e-d23b-8f9c6a010ebc 55111-149 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20021015 ANDA ANDA075465 Dr.Reddy's Laboratories Limited FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-153_e257810e-ee91-2847-a415-6114417c155d 55111-153 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20061226 ANDA ANDA076183 Dr.Reddy's Laboratories Limited ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55111-154_e257810e-ee91-2847-a415-6114417c155d 55111-154 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20061226 ANDA ANDA076183 Dr.Reddy's Laboratories Limited ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55111-156_e257810e-ee91-2847-a415-6114417c155d 55111-156 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20061226 ANDA ANDA076183 Dr.Reddy's Laboratories Limited ONDANSETRON HYDROCHLORIDE 24 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55111-157_7968a5a9-4dde-ef24-e1a0-4d55c6e72bda 55111-157 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Dr. Reddy's Laboratories Limited OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55111-158_7968a5a9-4dde-ef24-e1a0-4d55c6e72bda 55111-158 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Dr. Reddy's Laboratories Limited OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55111-159_7968a5a9-4dde-ef24-e1a0-4d55c6e72bda 55111-159 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Dr. Reddy's Laboratories Limited OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55111-160_abfa4cd4-5c6d-62cd-3d3a-ff5a393b8301 55111-160 HUMAN PRESCRIPTION DRUG Ofloxacin ofloxacin TABLET, COATED ORAL 20060210 ANDA ANDA077098 Dr. Reddy's Laboratories Limited OFLOXACIN 200 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55111-161_abfa4cd4-5c6d-62cd-3d3a-ff5a393b8301 55111-161 HUMAN PRESCRIPTION DRUG Ofloxacin ofloxacin TABLET, COATED ORAL 20060210 ANDA ANDA077098 Dr. Reddy's Laboratories Limited OFLOXACIN 300 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55111-162_abfa4cd4-5c6d-62cd-3d3a-ff5a393b8301 55111-162 HUMAN PRESCRIPTION DRUG Ofloxacin ofloxacin TABLET, COATED ORAL 20060210 ANDA ANDA077098 Dr. Reddy's Laboratories Limited OFLOXACIN 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55111-163_130ccf4c-24ab-50eb-812e-1f67437d82f4 55111-163 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Dr. Reddy's Laboratories Limited OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 55111-164_6cf3629c-b374-3f38-6ace-8b6a96776077 55111-164 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 20150930 ANDA ANDA076255 Dr.Reddy's laboratories Ltd. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 55111-165_6cf3629c-b374-3f38-6ace-8b6a96776077 55111-165 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 20150930 ANDA ANDA076255 Dr.Reddy's laboratories Ltd. OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 55111-166_6cf3629c-b374-3f38-6ace-8b6a96776077 55111-166 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 20150930 ANDA ANDA076255 Dr.Reddy's laboratories Ltd. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 55111-167_b1156728-30b3-1f4c-cd33-c247568faf74 55111-167 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076133 Dr.Reddy's laboratories Ltd. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 55111-168_b1156728-30b3-1f4c-cd33-c247568faf74 55111-168 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076133 Dr.Reddy's laboratories Ltd. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 55111-169_18830dca-10ef-986c-8a94-e5dd86934195 55111-169 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077380 Dr.Reddy's Laboratories Limited QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 55111-170_5ffb70b7-319b-02e2-7443-5b32555975ca 55111-170 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20010131 ANDA ANDA075855 Dr. Reddy's Laboratories Limited OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55111-171_0917aaac-8122-3208-97f8-33205bc7dbb2 55111-171 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20130102 ANDA ANDA076436 Dr. Reddy's Laboratories Limited FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 55111-172_1ea3d91d-9eae-f0cb-c631-141801302811 55111-172 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET ORAL 20070228 ANDA ANDA076437 Dr. Reddy's Laboratories Limited FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 55111-179_61d08685-8ab7-b71b-81e9-1b2a5e6f722c 55111-179 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Dr.Reddy's Laboratories Limited TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55111-180_61d08685-8ab7-b71b-81e9-1b2a5e6f722c 55111-180 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Dr.Reddy's Laboratories Limited TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55111-181_1953d6dd-5f8e-8dba-7067-5854b0ac7ebc 55111-181 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA076920 Dr. Reddy's Laboratories Limited LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55111-182_1953d6dd-5f8e-8dba-7067-5854b0ac7ebc 55111-182 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA076920 Dr. Reddy's Laboratories Limited LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55111-183_1953d6dd-5f8e-8dba-7067-5854b0ac7ebc 55111-183 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA076920 Dr. Reddy's Laboratories Limited LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55111-186_18830dca-10ef-986c-8a94-e5dd86934195 55111-186 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077380 Dr.Reddy's Laboratories Limited QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 55111-188_18830dca-10ef-986c-8a94-e5dd86934195 55111-188 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077380 Dr.Reddy's Laboratories Limited QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] 55111-189_18830dca-10ef-986c-8a94-e5dd86934195 55111-189 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077380 Dr.Reddy's Laboratories Limited QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 55111-190_18830dca-10ef-986c-8a94-e5dd86934195 55111-190 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077380 Dr.Reddy's Laboratories Limited QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 55111-196_b315618e-4834-df44-7680-5c35db92a4fb 55111-196 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA076273 Dr.Reddy's Laboratories Limited CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 55111-197_afb8cf92-de9d-af77-383d-6f37de3de331 55111-197 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20070816 ANDA ANDA078425 Dr. Reddy's Laboratories Limited SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55111-198_afb8cf92-de9d-af77-383d-6f37de3de331 55111-198 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Dr. Reddy's Laboratories Limited SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55111-199_afb8cf92-de9d-af77-383d-6f37de3de331 55111-199 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Dr. Reddy's Laboratories Limited SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55111-200_afb8cf92-de9d-af77-383d-6f37de3de331 55111-200 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Dr. Reddy's Laboratories Limited SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55111-201_bf566e93-0213-79fe-a099-32afa6cb9628 55111-201 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091024 ANDA ANDA076879 Dr. Reddy's Laboratories Limited RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 55111-202_bf566e93-0213-79fe-a099-32afa6cb9628 55111-202 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091024 ANDA ANDA076879 Dr. Reddy's Laboratories Limited RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 55111-203_bf566e93-0213-79fe-a099-32afa6cb9628 55111-203 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091024 ANDA ANDA076879 Dr. Reddy's Laboratories Limited RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 55111-204_bf566e93-0213-79fe-a099-32afa6cb9628 55111-204 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091024 ANDA ANDA076879 Dr. Reddy's Laboratories Limited RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 55111-205_bf566e93-0213-79fe-a099-32afa6cb9628 55111-205 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091024 ANDA ANDA076879 Dr. Reddy's Laboratories Limited RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 55111-206_bf566e93-0213-79fe-a099-32afa6cb9628 55111-206 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091024 ANDA ANDA076879 Dr. Reddy's Laboratories Limited RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 55111-207_464f97e0-be95-3534-46d6-4e40ac4c9f6e 55111-207 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20090224 ANDA ANDA077328 Dr. Reddy's Laboratories Limited RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 55111-208_464f97e0-be95-3534-46d6-4e40ac4c9f6e 55111-208 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091006 ANDA ANDA077328 Dr. Reddy's Laboratories Limited RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 55111-209_464f97e0-be95-3534-46d6-4e40ac4c9f6e 55111-209 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20090224 ANDA ANDA077328 Dr. Reddy's Laboratories Limited RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 55111-220_4c472709-29e3-2216-0e25-f4d4b3ec3200 55111-220 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090129 ANDA ANDA076708 Dr.Reddy's Laboratories Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-221_4c472709-29e3-2216-0e25-f4d4b3ec3200 55111-221 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090129 ANDA ANDA076708 Dr.Reddy's Laboratories Limited LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-222_4c472709-29e3-2216-0e25-f4d4b3ec3200 55111-222 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090129 ANDA ANDA076708 Dr.Reddy's Laboratories Limited LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-223_4c472709-29e3-2216-0e25-f4d4b3ec3200 55111-223 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090129 ANDA ANDA076708 Dr.Reddy's Laboratories Limited LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-225_f71e4461-dcd4-98fc-52b3-3e5c014d63d0 55111-225 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090129 ANDA ANDA076701 Dr. Reddy's Laboratories Limited LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-226_f71e4461-dcd4-98fc-52b3-3e5c014d63d0 55111-226 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090129 ANDA ANDA076701 Dr. Reddy's Laboratories Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-229_990dfc1d-ea50-42e3-a7d7-a54ffc50a13d 55111-229 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20091231 ANDA ANDA076714 Dr.Reddy's Laboratories Limited PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55111-230_990dfc1d-ea50-42e3-a7d7-a54ffc50a13d 55111-230 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20091231 ANDA ANDA076714 Dr.Reddy's Laboratories Limited PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55111-231_990dfc1d-ea50-42e3-a7d7-a54ffc50a13d 55111-231 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20091231 ANDA ANDA076714 Dr.Reddy's Laboratories Limited PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55111-248_960b7dc9-dd89-c124-1e63-c4456ea8a0cf 55111-248 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078904 Dr. Reddy's Laboratories Limited LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55111-249_18830dca-10ef-986c-8a94-e5dd86934195 55111-249 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077380 Dr.Reddy's Laboratories Limited QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 55111-250_13451699-7b0c-6dd9-7c7c-ff9b55a613d4 55111-250 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20070702 ANDA ANDA076390 Dr.Reddys Laboratories Limited TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 55111-252_87dce662-c425-8eaa-7e2d-9c458421513d 55111-252 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA076649 Dr. Reddy's Laboratories Limited CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55111-253_87dce662-c425-8eaa-7e2d-9c458421513d 55111-253 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA076649 Dr. Reddy's Laboratories Limited CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55111-254_87dce662-c425-8eaa-7e2d-9c458421513d 55111-254 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA076649 Dr. Reddy's Laboratories Limited CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55111-255_87dce662-c425-8eaa-7e2d-9c458421513d 55111-255 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA076649 Dr. Reddy's Laboratories Limited CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55111-256_2c442c46-c6c1-5b40-d962-b67249742c2d 55111-256 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077565 Dr. Reddy's Laboratories Limited ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 55111-257_2c442c46-c6c1-5b40-d962-b67249742c2d 55111-257 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077565 Dr. Reddy's Laboratories Limited ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 55111-258_2c442c46-c6c1-5b40-d962-b67249742c2d 55111-258 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077565 Dr. Reddy's Laboratories Limited ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 55111-259_2c442c46-c6c1-5b40-d962-b67249742c2d 55111-259 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077565 Dr. Reddy's Laboratories Limited ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 55111-262_1eec9e02-ffd7-19c0-887c-c0c805fe272a 55111-262 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA076534 Dr.Reddy's Laboratories Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 55111-263_1eec9e02-ffd7-19c0-887c-c0c805fe272a 55111-263 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA076534 Dr.Reddy's Laboratories Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 55111-264_1eec9e02-ffd7-19c0-887c-c0c805fe272a 55111-264 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA076534 Dr.Reddy's Laboratories Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 55111-265_1eec9e02-ffd7-19c0-887c-c0c805fe272a 55111-265 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA076534 Dr.Reddy's Laboratories Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 55111-268_afb8cf92-de9d-af77-383d-6f37de3de331 55111-268 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Dr. Reddy's Laboratories Limited SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55111-269_b1a220cd-5b4e-2660-4728-73b07ce5ed4e 55111-269 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070723 ANDA ANDA076692 Dr Reddy's Laboratories AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55111-270_b1a220cd-5b4e-2660-4728-73b07ce5ed4e 55111-270 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070723 ANDA ANDA076692 Dr Reddy's Laboratories AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55111-271_b1a220cd-5b4e-2660-4728-73b07ce5ed4e 55111-271 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070723 ANDA ANDA076692 Dr Reddy's Laboratories AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55111-272_b8cbfcde-dc47-157b-bf85-c1750343ee09 55111-272 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, COATED ORAL 19980729 ANDA ANDA075168 Dr.Reddy's Laboratories Limited NAPROXEN SODIUM 220 mg/1 55111-273_b8cbfcde-dc47-157b-bf85-c1750343ee09 55111-273 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, COATED ORAL 19980729 ANDA ANDA075168 Dr.Reddy's Laboratories Limited NAPROXEN SODIUM 220 mg/1 55111-274_990dfc1d-ea50-42e3-a7d7-a54ffc50a13d 55111-274 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20091231 ANDA ANDA076714 Dr.Reddy's Laboratories Limited PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55111-279_5b8dc848-9c5a-afa3-2f2c-3c7d4a4f67e0 55111-279 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076710 Dr. Reddy's Laboratories Limited LEVOFLOXACIN 250 mg/1 55111-280_5b8dc848-9c5a-afa3-2f2c-3c7d4a4f67e0 55111-280 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076710 Dr. Reddy's Laboratories Limited LEVOFLOXACIN 500 mg/1 55111-281_5b8dc848-9c5a-afa3-2f2c-3c7d4a4f67e0 55111-281 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076710 Dr. Reddy's Laboratories Limited LEVOFLOXACIN 750 mg/1 55111-282_4a494886-07b0-ece6-cde4-52b3e25e32a0 55111-282 HUMAN PRESCRIPTION DRUG levocetirizine dihydrochloride levocetirizine dihydrochloride TABLET, COATED ORAL 20110224 ANDA ANDA090392 Dr.Reddy's laboratories Ltd. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 55111-284_6af27ffd-65e4-8736-db4f-d34103d1095f 55111-284 HUMAN PRESCRIPTION DRUG Fluoxetine hydrochloride Fluoxetine Hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 20100324 ANDA ANDA078572 Dr.Reddy's Laboratories Limited FLUOXETINE HYDROCHLORIDE 90 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-288_e744c323-e44f-3dce-02c3-4faa458ec24f 55111-288 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077645 Dr. Reddy's Laboratories Limited ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55111-291_28538531-e60a-9b6e-0075-6fad1192eed3 55111-291 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Dr. Reddy's Laboratories Limited SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 55111-292_28538531-e60a-9b6e-0075-6fad1192eed3 55111-292 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Dr. Reddy's Laboratories Limited SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 55111-293_28538531-e60a-9b6e-0075-6fad1192eed3 55111-293 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Dr. Reddy's Laboratories Limited SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 55111-302_13bb1e32-afdc-2110-323d-9d54fc8c3745 55111-302 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20130726 ANDA ANDA202723 Dr. Reddys Laboratories Limited DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55111-310_a22628e4-69b2-d4af-ece1-39f62ed1f89f 55111-310 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20050915 ANDA ANDA077314 Dr Reddy's Laboratories Limited NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55111-311_a22628e4-69b2-d4af-ece1-39f62ed1f89f 55111-311 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20050915 ANDA ANDA077314 Dr Reddy's Laboratories Limited NIZATIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55111-320_f4af4daf-333c-778a-e2cd-c6d05c5a73a8 55111-320 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Dr. Reddy's Laboratories Limited GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55111-321_f4af4daf-333c-778a-e2cd-c6d05c5a73a8 55111-321 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Dr. Reddy's Laboratories Limited GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55111-322_f4af4daf-333c-778a-e2cd-c6d05c5a73a8 55111-322 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Dr. Reddy's Laboratories Limited GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55111-328_a31cfa65-5713-e7bf-4eef-e69aa3e9c9cd 55111-328 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET ORAL 20090909 ANDA ANDA077461 Dr. Reddy's Laboratories Limited NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 55111-329_a31cfa65-5713-e7bf-4eef-e69aa3e9c9cd 55111-329 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET ORAL 20090909 ANDA ANDA077461 Dr. Reddy's Laboratories Limited NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 55111-332_d52fd047-690d-070d-23d6-d2e70bd05b4d 55111-332 HUMAN PRESCRIPTION DRUG Pantoprazole Pantoprazole TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA077619 Dr.Reddy's Laboratories Limited PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55111-333_d52fd047-690d-070d-23d6-d2e70bd05b4d 55111-333 HUMAN PRESCRIPTION DRUG Pantoprazole Pantoprazole TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA077619 Dr.Reddy's Laboratories Limited PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55111-338_80864191-0092-5c8b-9b48-7bcf42020c58 55111-338 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 Dr.Reddy's Laboratories Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55111-339_80864191-0092-5c8b-9b48-7bcf42020c58 55111-339 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 Dr.Reddy's Laboratories Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55111-340_80864191-0092-5c8b-9b48-7bcf42020c58 55111-340 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 Dr.Reddy's Laboratories Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55111-341_80864191-0092-5c8b-9b48-7bcf42020c58 55111-341 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 Dr.Reddy's Laboratories Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55111-342_2153f0e6-6744-ce86-8829-f6e7adf4b35d 55111-342 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077038 Dr. Reddy's Laboratories Limited CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-343_2153f0e6-6744-ce86-8829-f6e7adf4b35d 55111-343 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077038 Dr. Reddy's Laboratories Limited CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-344_2153f0e6-6744-ce86-8829-f6e7adf4b35d 55111-344 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077038 Dr. Reddy's Laboratories Limited CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-349_77219f0e-f661-e6b5-6184-315f6bc9c7b2 55111-349 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20140407 ANDA ANDA090859 Dr. Reddy's Laboratories Limited FENOFIBRATE 43 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 55111-351_7136a472-c852-a4a1-9e11-c8dcb8b14a1f 55111-351 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20080115 ANDA ANDA078343 Dr.Reddy's Laboratories Limited CETIRIZINE HYDROCHLORIDE 10 mg/1 55111-352_8a38a0a1-ed35-6142-99e3-c553a7168881 55111-352 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20110901 ANDA ANDA077130 Dr.Reddy's Laboratories Limited RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55111-353_8a38a0a1-ed35-6142-99e3-c553a7168881 55111-353 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20110901 ANDA ANDA077130 Dr.Reddy's Laboratories Limited RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55111-354_8a38a0a1-ed35-6142-99e3-c553a7168881 55111-354 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20110901 ANDA ANDA077130 Dr.Reddy's Laboratories Limited RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55111-355_8a38a0a1-ed35-6142-99e3-c553a7168881 55111-355 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20110901 ANDA ANDA077130 Dr.Reddy's Laboratories Limited RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55111-356_fabc498c-ac46-ab6e-9669-fa500b218098 55111-356 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA201001 Dr. Reddys Laboratories Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55111-357_fabc498c-ac46-ab6e-9669-fa500b218098 55111-357 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA201001 Dr. Reddys Laboratories Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55111-360_38968cad-4da0-33be-9c26-918d28092f98 55111-360 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET, ORALLY DISINTEGRATING ORAL 20130111 ANDA ANDA078367 Dr. Reddy's Laboratories Limited DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 55111-366_f7edffd6-fedf-b831-450a-6da915162f6f 55111-366 HUMAN PRESCRIPTION DRUG Naproxen Tablets Naproxen Tablets TABLET ORAL 20040605 ANDA ANDA075927 Dr. Reddy's Laboratories Limited NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55111-367_f7edffd6-fedf-b831-450a-6da915162f6f 55111-367 HUMAN PRESCRIPTION DRUG Naproxen Tablets Naproxen Tablets TABLET ORAL 20040605 ANDA ANDA075927 Dr. Reddy's Laboratories Limited NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55111-368_f7edffd6-fedf-b831-450a-6da915162f6f 55111-368 HUMAN PRESCRIPTION DRUG Naproxen Tablets Naproxen Tablets TABLET ORAL 20040605 ANDA ANDA075927 Dr. Reddy's Laboratories Limited NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55111-372_b58c875f-c2b1-153b-c764-1648b26fe017 55111-372 HUMAN PRESCRIPTION DRUG sildenafil sildenafil TABLET, FILM COATED ORAL 20121107 ANDA ANDA202598 Dr. Reddy's Laboratories Limited SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 55111-395_77219f0e-f661-e6b5-6184-315f6bc9c7b2 55111-395 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20140407 ANDA ANDA090859 Dr. Reddy's Laboratories Limited FENOFIBRATE 130 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 55111-396_96630fbf-75a9-3a2e-1069-e8c0b5505136 55111-396 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20060930 ANDA ANDA077367 Dr.Reddys Laboratories Limited FAMOTIDINE 20 mg/1 55111-397_925a4d41-8aa6-6562-b305-11ee686d63b7 55111-397 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20100301 ANDA ANDA078878 Dr. Reddy's Laboratories Limited OMEPRAZOLE MAGNESIUM 20 mg/1 55111-397_b22f1035-a8e5-17be-0850-058295a39a04 55111-397 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20091112 ANDA ANDA078878 Dr. Reddy's Laboratories Limited OMEPRAZOLE MAGNESIUM 20 mg/1 55111-398_0afe7dc4-1210-353d-dfaf-5f96369b4450 55111-398 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20101015 ANDA ANDA091269 Dr.Reddy's Laboratories Ltd. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55111-399_0afe7dc4-1210-353d-dfaf-5f96369b4450 55111-399 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20101015 ANDA ANDA091269 Dr.Reddy's Laboratories Ltd. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55111-402_e744c323-e44f-3dce-02c3-4faa458ec24f 55111-402 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077645 Dr. Reddy's Laboratories Limited ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55111-403_e744c323-e44f-3dce-02c3-4faa458ec24f 55111-403 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077645 Dr. Reddy's Laboratories Limited ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55111-404_24c5b0ca-e73b-1a0b-d4e5-14cb0557a2e4 55111-404 HUMAN OTC DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET, COATED ORAL 20091202 ANDA ANDA078192 Dr. Reddy's Laboratories Limited RANITIDINE HYDROCHLORIDE 168 mg/1 55111-422_52f816f4-05ac-1372-790b-a02129c1d94e 55111-422 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070326 ANDA ANDA077902 Dr. Reddy's Laboratories Limited CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 212.6; 287.5 mg/1; mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55111-423_52f816f4-05ac-1372-790b-a02129c1d94e 55111-423 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20071031 ANDA ANDA077701 Dr. Reddy's Laboratories Limited CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 425.2; 574.9 mg/1; mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55111-428_e9222b3b-a7a6-02e5-0748-b1af54223141 55111-428 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20130620 ANDA ANDA202383 Dr.Reddy's Laboratories Limited LAMOTRIGINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-438_5fe1152c-5845-8a8d-9604-dd72d74f71b6 55111-438 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA078191 Dr. Reddy's Laboratories Limited RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55111-439_5fe1152c-5845-8a8d-9604-dd72d74f71b6 55111-439 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA078191 Dr. Reddy's Laboratories Limited RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55111-440_5fe1152c-5845-8a8d-9604-dd72d74f71b6 55111-440 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA078191 Dr. Reddy's Laboratories Limited RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55111-441_5fe1152c-5845-8a8d-9604-dd72d74f71b6 55111-441 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA078191 Dr. Reddy's Laboratories Limited RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55111-447_d2c05f67-590b-12fd-f197-f6f37d19f31a 55111-447 HUMAN OTC DRUG Fexofenadine HCl and Pseudoephedrine HCI Fexofenadine HCl and Pseudoephedrine HCI TABLET, EXTENDED RELEASE ORAL 20141118 ANDA ANDA076667 Dr. Reddy's Laboratories Limited FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 55111-453_4bd8053c-85ea-46fa-2f78-c47c3baf96b7 55111-453 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078421 Dr.Reddy's Laboratories Ltd. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-454_4bd8053c-85ea-46fa-2f78-c47c3baf96b7 55111-454 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078421 Dr.Reddy's Laboratories Ltd. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-455_4bd8053c-85ea-46fa-2f78-c47c3baf96b7 55111-455 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078421 Dr.Reddy's Laboratories Ltd. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-466_9cbdb7fd-fac4-84b2-ae1c-770d3536d55b 55111-466 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Dr. Reddy's Laboratories Limited METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55111-467_9cbdb7fd-fac4-84b2-ae1c-770d3536d55b 55111-467 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Dr. Reddy's Laboratories Limited METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55111-468_2a1ffb8b-24bc-cd1b-7f80-967fd0e75aac 55111-468 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA078889 Dr. Reddy's Laboratories Limited METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55111-469_2a1ffb8b-24bc-cd1b-7f80-967fd0e75aac 55111-469 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA078889 Dr. Reddy's Laboratories Limited METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55111-470_464f97e0-be95-3534-46d6-4e40ac4c9f6e 55111-470 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091130 ANDA ANDA077328 Dr. Reddy's Laboratories Limited RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 55111-471_464f97e0-be95-3534-46d6-4e40ac4c9f6e 55111-471 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091130 ANDA ANDA077328 Dr. Reddy's Laboratories Limited RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 55111-472_7fc2ea11-9678-2fc4-0140-337e2dd6d2f7 55111-472 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20090304 ANDA ANDA078246 Dr. Reddy's Laboratories Ltd BUSPIRONE HYDROCHLORIDE 5 mg/1 55111-473_7fc2ea11-9678-2fc4-0140-337e2dd6d2f7 55111-473 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20090304 ANDA ANDA078246 Dr. Reddy's Laboratories Ltd BUSPIRONE HYDROCHLORIDE 10 mg/1 55111-474_7fc2ea11-9678-2fc4-0140-337e2dd6d2f7 55111-474 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20090304 ANDA ANDA078246 Dr. Reddy's Laboratories Ltd BUSPIRONE HYDROCHLORIDE 15 mg/1 55111-475_7fc2ea11-9678-2fc4-0140-337e2dd6d2f7 55111-475 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20090304 ANDA ANDA078246 Dr. Reddy's Laboratories Ltd BUSPIRONE HYDROCHLORIDE 30 mg/1 55111-476_59ee4631-0d3f-26a9-6b7a-5f265d6298ea 55111-476 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20081003 ANDA ANDA040862 Dr. Reddy's Laboratories Ltd PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55111-477_59ee4631-0d3f-26a9-6b7a-5f265d6298ea 55111-477 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20081003 ANDA ANDA040862 Dr. Reddy's Laboratories Ltd PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55111-478_d5aeb471-b5af-b169-c662-938ae8c15d8e 55111-478 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA077985 Dr. Reddy's Laboratories Limited ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55111-479_d5aeb471-b5af-b169-c662-938ae8c15d8e 55111-479 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA077985 Dr. Reddy's Laboratories Limited ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55111-525_9f5c7efa-1639-eed4-1f37-b6ee1cd9fa4a 55111-525 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20100514 ANDA ANDA090509 Dr. Reddy's Laboratories Limited TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 55111-526_9f5c7efa-1639-eed4-1f37-b6ee1cd9fa4a 55111-526 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20100514 ANDA ANDA090509 Dr. Reddy's Laboratories Limited TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 55111-527_9f5c7efa-1639-eed4-1f37-b6ee1cd9fa4a 55111-527 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20100514 ANDA ANDA090509 Dr. Reddy's Laboratories Limited TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 55111-529_c63f181a-0b57-aaa0-e04c-ad7e6ca7649c 55111-529 HUMAN PRESCRIPTION DRUG divalproex sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078755 Dr. Reddy's Laboratories Ltd DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-530_c63f181a-0b57-aaa0-e04c-ad7e6ca7649c 55111-530 HUMAN PRESCRIPTION DRUG divalproex sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078755 Dr. Reddy's Laboratories Ltd DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-531_c63f181a-0b57-aaa0-e04c-ad7e6ca7649c 55111-531 HUMAN PRESCRIPTION DRUG divalproex sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078755 Dr. Reddy's Laboratories Ltd DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-532_664a93db-b93a-3b74-a3ab-4f930303d98c 55111-532 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium CAPSULE ORAL 20090123 ANDA ANDA078979 Dr. Reddy's Laboratories Ltd DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-533_94005eb9-7b63-b3e3-42bb-a8d5c72ca649 55111-533 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20130811 ANDA ANDA090161 Dr. Reddy's Laboratories Ltd DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-534_a5f5de79-ce60-db4d-060c-5251c8e000fc 55111-534 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20130811 ANDA ANDA090070 Dr. Reddy's Laboratories Ltd DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-545_d23adbf8-2c6a-76ae-c7e7-4dfa626a560d 55111-545 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride TABLET ORAL 20080616 ANDA ANDA078301 Dr. Reddy's Laboratories Limited VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-546_d23adbf8-2c6a-76ae-c7e7-4dfa626a560d 55111-546 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride TABLET ORAL 20080616 ANDA ANDA078301 Dr. Reddy's Laboratories Limited VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-547_d23adbf8-2c6a-76ae-c7e7-4dfa626a560d 55111-547 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride TABLET ORAL 20080616 ANDA ANDA078301 Dr. Reddy's Laboratories Limited VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-548_d23adbf8-2c6a-76ae-c7e7-4dfa626a560d 55111-548 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride TABLET ORAL 20080616 ANDA ANDA078301 Dr. Reddy's Laboratories Limited VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-549_d23adbf8-2c6a-76ae-c7e7-4dfa626a560d 55111-549 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride TABLET ORAL 20080616 ANDA ANDA078301 Dr. Reddy's Laboratories Limited VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-551_38968cad-4da0-33be-9c26-918d28092f98 55111-551 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET, ORALLY DISINTEGRATING ORAL 20130111 ANDA ANDA078367 Dr. Reddy's Laboratories Limited DESLORATADINE 2.5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 55111-552_8d4b0d73-3618-171b-e90a-fdeeeded3810 55111-552 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20101206 ANDA ANDA079012 Dr. Reddys Laboratories Limited VALACYCLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55111-553_8d4b0d73-3618-171b-e90a-fdeeeded3810 55111-553 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20101206 ANDA ANDA079012 Dr. Reddys Laboratories Limited VALACYCLOVIR 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55111-556_c0d62859-e075-7b19-670b-ebdde833a2f3 55111-556 HUMAN PRESCRIPTION DRUG Decitabine Decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130711 ANDA ANDA203131 Dr.Reddy's Laboratories Limited DECITABINE 50 mg/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 55111-557_5cfa5dd8-316d-c497-68dd-ab357e8eaff7 55111-557 HUMAN OTC DRUG Fexofenadine HCl and Pseudoephedrine HCI Fexofenadine HCl and Pseudoephedrine HCI TABLET, EXTENDED RELEASE ORAL 20110824 ANDA ANDA079043 Dr.Reddy's Laboratories Limited FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180; 240 mg/1; mg/1 55111-565_2b892a41-1540-179c-df44-322f3c3ba529 55111-565 HUMAN OTC DRUG Ibuprofen and Diphenhydramine Citrate Ibuprofen and Diphenhydramine Citrate TABLET ORAL 20100131 ANDA ANDA090619 Dr. Reddy's Laboratories Limited DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 55111-572_83e76d7d-2a89-fe13-b319-56a5470a69b0 55111-572 HUMAN PRESCRIPTION DRUG Fexofenadine HCl and Pseudoephedrine HCl Fexofenadine HCl and Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20110128 ANDA ANDA079043 Dr.Reddy's Laboratories Limited FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180; 240 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 55111-575_922847a8-06ed-fd2a-14fa-0bdbf12d06f0 55111-575 HUMAN PRESCRIPTION DRUG Ibandronate sodium Ibandronate sodium TABLET ORAL 20120621 ANDA ANDA078997 Dr. Reddy's Laboratories Limited IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 55111-579_38aae1c5-bc93-a425-927b-d976faf90bb4 55111-579 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20090729 ANDA ANDA078909 Dr. Reddy's Laboratories Limited RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] 55111-586_91ecb537-c498-4035-0641-4b499c70ec76 55111-586 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA090149 Dr.Reddy's Laboratories Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55111-587_91ecb537-c498-4035-0641-4b499c70ec76 55111-587 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA090149 Dr.Reddy's Laboratories Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55111-593_2945682e-faa8-1aa3-8d13-cbdb9663b7b4 55111-593 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120806 ANDA ANDA201581 Dr.Reddy's Laboratories Limited MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 55111-594_2945682e-faa8-1aa3-8d13-cbdb9663b7b4 55111-594 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120806 ANDA ANDA201581 Dr.Reddy's Laboratories Limited MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 55111-602_5d1e0596-f1ae-ff0a-babb-dd16a97d915e 55111-602 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SYRUP ORAL 20090526 ANDA ANDA090102 Dr. Reddy's Laboratories Limited RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55111-606_18830dca-10ef-986c-8a94-e5dd86934195 55111-606 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077380 Dr.Reddy's Laboratories Limited QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 55111-608_4c558e81-93a2-83cc-8239-3d0a895052d2 55111-608 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20140618 ANDA ANDA090723 Dr. Reddy's Laboratories Limited DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-609_4c558e81-93a2-83cc-8239-3d0a895052d2 55111-609 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20140618 ANDA ANDA090723 Dr. Reddy's Laboratories Limited DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-610_4c558e81-93a2-83cc-8239-3d0a895052d2 55111-610 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20140618 ANDA ANDA090723 Dr. Reddy's Laboratories Limited DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55111-617_043eb1ef-2db6-d085-4961-a34a0fd7824e 55111-617 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, COATED ORAL 20140415 ANDA ANDA091024 Dr. Reddy's Laboratories Limited ESZOPICLONE 3 mg/1 55111-619_043eb1ef-2db6-d085-4961-a34a0fd7824e 55111-619 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, COATED ORAL 20140415 ANDA ANDA091024 Dr. Reddy's Laboratories Limited ESZOPICLONE 2 mg/1 55111-621_58a1cc9b-12bf-5c5c-576b-cde2b5bb64bf 55111-621 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20070720 ANDA ANDA078457 Dr.Reddy's Laboratories Limited QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55111-622_58a1cc9b-12bf-5c5c-576b-cde2b5bb64bf 55111-622 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20070720 ANDA ANDA078457 Dr.Reddy's Laboratories Limited QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55111-623_58a1cc9b-12bf-5c5c-576b-cde2b5bb64bf 55111-623 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20070720 ANDA ANDA078457 Dr.Reddy's Laboratories Limited QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55111-624_58a1cc9b-12bf-5c5c-576b-cde2b5bb64bf 55111-624 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20070720 ANDA ANDA078457 Dr.Reddy's Laboratories Limited QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55111-625_f8d7ff01-8167-c19d-4889-c944fb9dc74c 55111-625 HUMAN PRESCRIPTION DRUG Zafirlukast Zafirlukast TABLET, FILM COATED ORAL 20101118 ANDA ANDA090372 Dr. Reddys Laboratories Limited ZAFIRLUKAST 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55111-626_f8d7ff01-8167-c19d-4889-c944fb9dc74c 55111-626 HUMAN PRESCRIPTION DRUG Zafirlukast Zafirlukast TABLET, FILM COATED ORAL 20101118 ANDA ANDA090372 Dr. Reddys Laboratories Limited ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55111-629_043eb1ef-2db6-d085-4961-a34a0fd7824e 55111-629 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, COATED ORAL 20140415 ANDA ANDA091024 Dr. Reddy's Laboratories Limited ESZOPICLONE 1 mg/1 55111-637_dd8e91a9-12f3-332f-a98f-273ebc531a03 55111-637 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED ORAL 20080123 ANDA ANDA065436 Dr. Reddy's Laboratories Limited MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 55111-638_dd8e91a9-12f3-332f-a98f-273ebc531a03 55111-638 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED ORAL 20080123 ANDA ANDA065436 Dr. Reddy's Laboratories Limited MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 55111-639_dd8e91a9-12f3-332f-a98f-273ebc531a03 55111-639 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED ORAL 20080123 ANDA ANDA065436 Dr. Reddy's Laboratories Limited MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 55111-640_4995ef74-5377-6fdf-5a0a-0ea1925c35fb 55111-640 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20080103 ANDA ANDA040797 Dr.Reddy's Laboratories Limited MEPROBAMATE 200 mg/1 CIV 55111-641_4995ef74-5377-6fdf-5a0a-0ea1925c35fb 55111-641 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20080103 ANDA ANDA040797 Dr.Reddy's Laboratories Limited MEPROBAMATE 400 mg/1 CIV 55111-643_85797fd2-5d4b-e993-6ac4-77a90ea82a50 55111-643 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20140301 ANDA ANDA078490 Dr. Reddy's Laboratories Limited OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55111-644_85797fd2-5d4b-e993-6ac4-77a90ea82a50 55111-644 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20140301 ANDA ANDA078490 Dr. Reddy's Laboratories Limited OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55111-645_85797fd2-5d4b-e993-6ac4-77a90ea82a50 55111-645 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20140301 ANDA ANDA078490 Dr. Reddy's Laboratories Limited OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55111-646_e38a7bdd-e85a-2f03-c868-036ff4bbf812 55111-646 HUMAN PRESCRIPTION DRUG Letrozole Letrozole TABLET, FILM COATED ORAL 20110603 ANDA ANDA091191 Dr. Reddy's Laboratories Limited LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 55111-647_2995fa61-2385-f7e1-d028-beca0e052a3d 55111-647 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, FILM COATED ORAL 20100628 ANDA ANDA090732 Dr. Reddy's Laboratories Limited ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 55111-648_eed18c49-77e2-8707-4081-f7f9121885c4 55111-648 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20080714 ANDA ANDA040847 Dr. Reddy's Laboratories Limited GLYCOPYRROLATE 1 mg/1 55111-649_eed18c49-77e2-8707-4081-f7f9121885c4 55111-649 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20080714 ANDA ANDA040847 Dr. Reddy's Laboratories Limited GLYCOPYRROLATE 1 mg/1 55111-653_30e94c3b-9ba6-ca16-3f11-003c78ebb8b8 55111-653 HUMAN PRESCRIPTION DRUG Sirolimus Sirolimus TABLET ORAL 20141027 ANDA ANDA201578 Dr. Reddy's Laboratories Limited SIROLIMUS 1 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA] 55111-654_30e94c3b-9ba6-ca16-3f11-003c78ebb8b8 55111-654 HUMAN PRESCRIPTION DRUG Sirolimus Sirolimus TABLET ORAL 20141027 ANDA ANDA201578 Dr. Reddy's Laboratories Limited SIROLIMUS 2 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA] 55111-659_fe6ec06a-52ad-c09f-d15f-94ce9038d61c 55111-659 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA201576 Dr. Reddys Laboratories Limited ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55111-661_fe6ec06a-52ad-c09f-d15f-94ce9038d61c 55111-661 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA201576 Dr. Reddys Laboratories Limited ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55111-662_fe6ec06a-52ad-c09f-d15f-94ce9038d61c 55111-662 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA201576 Dr. Reddys Laboratories Limited ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55111-663_f34c7204-b65e-a776-d33c-5c3a02f97841 55111-663 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20140625 ANDA ANDA091412 Dr. Reddy's Laboratories Limited PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 55111-664_f34c7204-b65e-a776-d33c-5c3a02f97841 55111-664 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20140625 ANDA ANDA091412 Dr. Reddy's Laboratories Limited PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 55111-665_f34c7204-b65e-a776-d33c-5c3a02f97841 55111-665 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20140625 ANDA ANDA091412 Dr. Reddy's Laboratories Limited PARICALCITOL 4 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 55111-671_4960e984-cf5c-ae7f-7f97-be9779080ce1 55111-671 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA091023 Dr.Reddy's Laboratories Limited CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 55111-678_eea2e670-81bf-9c5e-89d2-7c0a5e84a0b9 55111-678 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium Fondaparinux Sodium INJECTION SUBCUTANEOUS 20110714 ANDA ANDA091316 Dr. Reddy's Laboratories Limited FONDAPARINUX SODIUM 2.5 mg/.5mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 55111-679_eea2e670-81bf-9c5e-89d2-7c0a5e84a0b9 55111-679 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium Fondaparinux Sodium INJECTION SUBCUTANEOUS 20110714 ANDA ANDA091316 Dr. Reddy's Laboratories Limited FONDAPARINUX SODIUM 5 mg/.4mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 55111-680_eea2e670-81bf-9c5e-89d2-7c0a5e84a0b9 55111-680 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium Fondaparinux Sodium INJECTION SUBCUTANEOUS 20110714 ANDA ANDA091316 Dr. Reddy's Laboratories Limited FONDAPARINUX SODIUM 7.5 mg/.6mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 55111-681_eea2e670-81bf-9c5e-89d2-7c0a5e84a0b9 55111-681 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium Fondaparinux Sodium INJECTION SUBCUTANEOUS 20110714 ANDA ANDA091316 Dr. Reddy's Laboratories Limited FONDAPARINUX SODIUM 10 mg/.8mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 55111-682_72bf5800-2267-25b1-0c1d-d52cdcd18bc8 55111-682 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Dr. Reddy's Laboratories Limited IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55111-683_72bf5800-2267-25b1-0c1d-d52cdcd18bc8 55111-683 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Dr. Reddy's Laboratories Limited IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55111-684_72bf5800-2267-25b1-0c1d-d52cdcd18bc8 55111-684 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Dr. Reddy's Laboratories Limited IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55111-685_e9848b4d-f8c3-db39-f660-d6b167a21b80 55111-685 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130304 ANDA ANDA091186 Dr. Reddy's Laboratories Limited ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 55111-686_d6a4308a-e499-a35b-be95-5f2b05772131 55111-686 HUMAN PRESCRIPTION DRUG gemcitabine gemcitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA091365 Dr. Reddy's Laboratories Limited GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 55111-687_d6a4308a-e499-a35b-be95-5f2b05772131 55111-687 HUMAN PRESCRIPTION DRUG gemcitabine gemcitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA091365 Dr. Reddy's Laboratories Limited GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 55111-688_8b9fd184-aaac-a6de-5e7a-1e0f6e242590 55111-688 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION INTRAVENOUS 20130403 ANDA ANDA091363 Dr.Reddy's Laboratories Ltd ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 55111-693_6f226f26-3282-49e2-b8f5-c0246b196a5a 55111-693 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate INJECTION SUBCUTANEOUS 20140224 ANDA ANDA090495 Dr. Reddy's Laboratories Limited SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 55111-695_279b92ac-8e31-4b04-8983-6f161f5b709c 55111-695 HUMAN PRESCRIPTION DRUG GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET ORAL 20090630 ANDA ANDA079009 Dr. Reddy's Laboratories Limited GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 55111-696_279b92ac-8e31-4b04-8983-6f161f5b709c 55111-696 HUMAN PRESCRIPTION DRUG GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET ORAL 20090630 ANDA ANDA079009 Dr. Reddy's Laboratories Limited GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 55111-697_279b92ac-8e31-4b04-8983-6f161f5b709c 55111-697 HUMAN PRESCRIPTION DRUG GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET ORAL 20090630 ANDA ANDA079009 Dr. Reddy's Laboratories Limited GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 55111-699_7136a472-c852-a4a1-9e11-c8dcb8b14a1f 55111-699 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20080115 ANDA ANDA078343 Dr.Reddy's Laboratories Limited CETIRIZINE HYDROCHLORIDE 10 mg/1 55111-700_49ea1ba3-0ae5-04e4-9d4f-20740052320f 55111-700 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SYRUP ORAL 20090820 ANDA ANDA078870 Dr. Reddy's Laboratories Limited CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 55111-717_e9222b3b-a7a6-02e5-0748-b1af54223141 55111-717 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20130620 ANDA ANDA202383 Dr.Reddy's Laboratories Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-718_e9222b3b-a7a6-02e5-0748-b1af54223141 55111-718 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20130620 ANDA ANDA202383 Dr.Reddy's Laboratories Limited LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-719_e9222b3b-a7a6-02e5-0748-b1af54223141 55111-719 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20130620 ANDA ANDA202383 Dr.Reddy's Laboratories Limited LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-720_e9222b3b-a7a6-02e5-0748-b1af54223141 55111-720 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20130620 ANDA ANDA202383 Dr.Reddy's Laboratories Limited LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55111-725_2945682e-faa8-1aa3-8d13-cbdb9663b7b4 55111-725 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, COATED ORAL 20120806 ANDA ANDA201582 Dr.Reddy's Laboratories Limited MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 55111-727_fe6ec06a-52ad-c09f-d15f-94ce9038d61c 55111-727 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA201576 Dr. Reddys Laboratories Limited ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55111-728_fe6ec06a-52ad-c09f-d15f-94ce9038d61c 55111-728 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA201576 Dr. Reddys Laboratories Limited ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55111-729_8200fd05-dd33-4d59-a7c2-45432378c46e 55111-729 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET, COATED ORAL 20091001 ANDA ANDA071586 Dr. Reddy's Laboratories Limited ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 55111-730_8200fd05-dd33-4d59-a7c2-45432378c46e 55111-730 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET, COATED ORAL 20091001 ANDA ANDA071587 Dr. Reddy's Laboratories Limited ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 55111-739_72cd1417-804f-bcbd-9964-47d7f8ff1804 55111-739 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202194 Dr. Reddy's Laboratories Limited LANSOPRAZOLE 15 mg/1 55111-762_a96e28d8-775e-e3cd-787e-731dedfb0227 55111-762 HUMAN PRESCRIPTION DRUG Valganciclovir Valganciclovir TABLET, FILM COATED ORAL 20141215 ANDA ANDA203511 Dr. Reddy's Laboratories Limited VALGANCICLOVIR HYDROCHLORIDE 450 mg/1 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 55111-763_f7c9ebd6-77c2-fff5-a400-b09fd9166a73 55111-763 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium GRANULE ORAL 20120920 ANDA ANDA202906 Dr.Reddy's Laboratories Limited MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 55111-784_9a2f5c78-936a-00cb-aba8-89fe0a8422f2 55111-784 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET ORAL 20110103 ANDA ANDA076502 Dr. Reddy's Laboratories Limited FEXOFENADINE HYDROCHLORIDE 180 mg/1 55115-2041_271a251e-d256-40f3-8a4a-df9c4a8e485a 55115-2041 HUMAN OTC DRUG aloevella Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20111114 OTC MONOGRAPH FINAL part352 Ojas Enterprises LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 15 g/100g; g/100g 55118-205_91c0597d-3805-4005-8e15-0d23c5513c90 55118-205 HUMAN OTC DRUG Scott Clear Antibacterial Skin Cleanser Triclosan SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation TRICLOSAN .25 g/100mL 55118-225_05d607ad-4023-445e-96ad-9369383704fb 55118-225 HUMAN OTC DRUG Scott Antibacterial Skin Cleanser Chloroxylenol SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation CHLOROXYLENOL .5 g/100mL 55118-245_8022ee20-61f7-4ecc-b2b6-ae1140d8e7d9 55118-245 HUMAN OTC DRUG Scott Antiseptic Skin Cleanser Chloroxylenol SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation CHLOROXYLENOL 1.25 g/100mL 55118-305_5192acfe-022f-40b0-b0d7-8387c0495bcf 55118-305 HUMAN OTC DRUG Kleenex Instant Hand Sanitizer Alcohol SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation ALCOHOL 62 mL/100mL 55118-325_7b3d17bd-13ab-4dca-a9e2-bb08797adaff 55118-325 HUMAN OTC DRUG Scott Moisturizing Instant Hand Sanitizer Alcohol SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation ALCOHOL 62 mL/100mL 55118-425_20f76305-63fd-4aa3-abc6-d27ed47f76ea 55118-425 HUMAN OTC DRUG Scott Antibacterial Triclosan SOLUTION TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation TRICLOSAN 5 g/L 55118-440_a12a5460-496b-4d3e-ae66-8375f8a13a5f 55118-440 HUMAN OTC DRUG KLEENEX Antimicrobial Skin Cleanser Benzalkonium Chloride SOLUTION TOPICAL 20130620 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation BENZALKONIUM CHLORIDE .013 mg/L 55118-480_da87db9e-c6bc-4019-9d92-bda7b12925e1 55118-480 HUMAN OTC DRUG Kleenex Moisturizing Instant Hand Sanitizer Alcohol SOLUTION TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation ALCOHOL 62 mL/100mL 55118-530_eeb3a137-765c-4cb0-b49f-2b8c43a36e6b 55118-530 HUMAN OTC DRUG Kleenex Ultra Moisturizing Hand Sanitizer Alcohol SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation ALCOHOL 70 mL/100mL 55118-535_535baf12-fb0d-4c3a-a399-f33f9df6e30f 55118-535 HUMAN OTC DRUG Kleenex Hand Sanitizer, Green Certified Alcohol SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation ALCOHOL 70 mL/100mL 55118-541_8ade8a1c-08b5-4c98-9795-3579a563dd7b 55118-541 HUMAN OTC DRUG KLEENEX Alcohol Free Foam Hand Sanitizer Benzalkonium Chloride SOLUTION TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL 55118-545_5731b33e-1dff-4c35-b0cd-485b4c60fe0a 55118-545 HUMAN OTC DRUG Kleenex Moisturizing Hand Sanitizer, Hydrates Skin Alcohol SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation ALCOHOL 62 mL/100mL 55118-550_5a67855f-5885-49b1-a2a9-6f4424972fd7 55118-550 HUMAN OTC DRUG Kleenex Antibacterial Skin Cleanser Fragrance Free Benzalkonium Chloride SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation BENZALKONIUM CHLORIDE 1.3 g/L 55118-555_84c49371-c5e7-4301-8156-1bf01d1d6d8b 55118-555 HUMAN OTC DRUG Scott Triclosan Free Antibacterial Skin Cleanser Benzalkonium Chloride SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation BENZALKONIUM CHLORIDE .13 g/100mL 55118-560_44c2c832-1f16-4a6e-9fce-a83c33ec7b1e 55118-560 HUMAN OTC DRUG Kleenex Antibacterial Skin Cleanser Benzalkonium Chloride SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation BENZALKONIUM CHLORIDE 1.3 g/L 55118-565_5c76fdc5-f0e6-42bf-a8c2-92a539a78d9c 55118-565 HUMAN OTC DRUG KLEENEX Antibacterial Skin Cleanser Triclosan SOLUTION TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation TRICLOSAN 5 g/L 55118-570_fad5278b-c6a5-4c95-9c9d-795079d116cd 55118-570 HUMAN OTC DRUG KLEENEX E2 Foam Skin Cleanser Chloroxylenol SOLUTION TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation CHLOROXYLENOL .0175 L/L 55118-571_16106482-7231-4892-bee9-83a4f34443f8 55118-571 HUMAN OTC DRUG Kleenex Antiseptic Skin Cleanser Chloroxylenol SOLUTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation CHLOROXYLENOL 17.5 g/L 55118-575_448e57af-ad75-41e9-b0aa-70520a9a7292 55118-575 HUMAN OTC DRUG KLEENEX Antibacterial Skin Cleanser Triclosan SOLUTION TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation TRICLOSAN 2.5 g/L 55118-580_285498ea-7457-4aa6-9076-f462fa009c4f 55118-580 HUMAN OTC DRUG KLEENEX Antiseptic Hand Rub with Moisturizers Alcohol SOLUTION TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation ALCOHOL .7 L/L 55118-600_858ce55b-2916-4778-bbfd-9e88cbb81c11 55118-600 HUMAN OTC DRUG Sunscreen Mango and Coconut Avobenzone, Octinoxate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100315 OTC MONOGRAPH NOT FINAL part352 Kimberly-Clark Corporation AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 10; 75; 50; 8; 50 mg/g; mg/g; mg/g; mg/g; mg/g 55118-605_33f8bb1a-8b58-4f69-b65c-6b31d9903887 55118-605 HUMAN OTC DRUG Truist Sunscreen Moisturizer Avobenzone, HOMOSALATE, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130620 OTC MONOGRAPH NOT FINAL part352 Kimberly-Clark Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 27; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 55118-610_05132d26-2d7a-4c1a-8f85-b500a1b63fde 55118-610 HUMAN OTC DRUG KLEENEX Hand Sanitizer Alcohol SOLUTION TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation ALCOHOL 70 mL/100mL 55118-976_486d5f31-f764-4bb3-9159-ed24f50aae3c 55118-976 HUMAN PRESCRIPTION DRUG KIMVENT ORAL CARE Q4 KIT WITH CHG Chlorhexidine Gluconate and Hydrogen Peroxide KIT 19960507 ANDA ANDA074356 Kimberly-Clark Corporation 55118-977_7087c2b0-63d7-42a2-aceb-45673339f106 55118-977 HUMAN OTC DRUG Kimvent Oral Care Q4 Kit Hydrogen peroxide KIT 20080313 OTC MONOGRAPH NOT FINAL part356 Kimberly-Clark Corporation 55118-978_78382558-77c8-4349-9832-dd98b89cf14a 55118-978 HUMAN PRESCRIPTION DRUG Kimvent Oral Care Q2 Kit with CHG Hydrogen peroxide and Chlorhexidine Gluconate KIT 19960507 ANDA ANDA074356 Kimberly-Clark Corporation 55118-979_f4233282-2c81-48cf-8a3a-67fd819efc40 55118-979 HUMAN OTC DRUG Kimvent Q2 oral care kit Hydrogen peroxide KIT 20080826 OTC MONOGRAPH NOT FINAL part356 Kimberly-Clark Corporation 55118-980_eeb730f4-96d1-4dd0-bcf0-1037f7a78844 55118-980 HUMAN OTC DRUG Kimvent Oral Care Toothbrush pack Cetylpyridinium Chloride KIT 20080313 OTC MONOGRAPH NOT FINAL part356 Kimberly-Clark Corporation 55118-990_8a119b2c-f195-4abe-8461-f5b0d5ed26fb 55118-990 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID ORAL 20080826 OTC MONOGRAPH NOT FINAL part356 Kimberly-Clark Corporation HYDROGEN PEROXIDE .015 mg/mL 55118-993_8a119b2c-f195-4abe-8461-f5b0d5ed26fb 55118-993 HUMAN OTC DRUG Kimvent Oral Care Suction Swab pack Hydrogen Peroxide KIT 20080826 OTC MONOGRAPH NOT FINAL part356 Kimberly-Clark Corporation 55128-001_787099e9-e4fe-4005-b081-e75f82289037 55128-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19820101 UNAPPROVED MEDICAL GAS Terre Haute Home Health Care Products dba Anderson's Medical Products OXYGEN 99 L/100L 55133-010_820d2b2e-c813-4830-9883-4abb6d17373c 55133-010 HUMAN OTC DRUG Snail Aqua EGF Sleep Witch Hazel, Dimethicone CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part347 HANBANGMEIN COSMETICS DIMETHICONE; WITCH HAZEL .3; .3 mg/30mL; mg/30mL 55133-020_7488b30d-faca-47d1-a40c-2b7e4c0f6e88 55133-020 HUMAN OTC DRUG EGF Premium Antiaging Eye Dimethicone, Allantoin CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part347 HANBANGMEIN COSMETICS ALLANTOIN; DIMETHICONE .15; .3 mg/30mL; mg/30mL 55133-030_114410d7-da78-4369-aa8f-050e2da49521 55133-030 HUMAN OTC DRUG EGF Premium Antiaging Special Dimethicone, Allantoin CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part347 HANBANGMEIN COSMETICS ALLANTOIN; DIMETHICONE .25; .5 mg/50mL; mg/50mL 55133-040_43e5ae94-bada-4d01-a6ff-19482e9cf6e3 55133-040 HUMAN OTC DRUG EGF Premium Whitening Milk Dimethicone, Allantoin LOTION TOPICAL 20121001 OTC MONOGRAPH FINAL part347 HANBANGMEIN COSMETICS ALLANTOIN; DIMETHICONE .75; 1.5 mg/150mL; mg/150mL 55133-050_86a26c66-a17c-4f52-99bf-8ca2f7aa96d6 55133-050 HUMAN OTC DRUG EGF Premium Whitening Skin Allantoin LOTION TOPICAL 20121001 OTC MONOGRAPH FINAL part347 HANBANGMEIN COSMETICS ALLANTOIN .75 mg/150mL 55138-001_73214ad9-3c1a-463a-9467-36404bd462d1 55138-001 HUMAN OTC DRUG Brain Power Semecarpus Anacardium Juice, Arnica Montana, Calcium Fluoride, Silybum Marianum Seed, Cinchona Officinalis Bark, Herring Sperm DNA, Ginkgo, Egg Phospholipids, Achillea Millefolium, Phosphoric Acid, Saccharomyces Cerevisia RNA, Silicon Dioxide, and Zinc Sulphate Heptahydrate SPRAY ORAL 20131113 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. ACHILLEA MILLEFOLIUM; ARNICA MONTANA; CALCIUM FLUORIDE; CINCHONA OFFICINALIS BARK; EGG PHOSPHOLIPIDS; GINKGO; HERRING SPERM DNA; PHOSPHORIC ACID; SACCHAROMYCES CEREVISIAE RNA; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SILYBUM MARIANUM SEED OIL; ZINC SULFATE HEPTAHYDRATE 1.5; 1.5; 30; 3; 6; 3; 3; 30; 6; 30; 6; 1.5; 6 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL 55138-003_57497b7c-cf97-4b11-82b6-50c3961fbd01 55138-003 HUMAN OTC DRUG Immune Booster Apis Mellifera, Baptisia Tinctoria, Silybum Marianum Seed, Herring Sperm DNA, Echinacea, Galium Aparine, Mercuric Chloride, Mercuric Sulfide, Nitric Acid, Sulfur Iodide, and Thuja Occidentalis Leafy Twig SPRAY ORAL 20131113 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. APIS MELLIFERA; BAPTISIA TINCTORIA; ECHINACEA, UNSPECIFIED; GALIUM APARINE; HERRING SPERM DNA; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; SILYBUM MARIANUM SEED OIL; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG 200; 3; 3; 1.5; 3; 200; 30; 30; 1.5; 200; 200 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL 55138-004_3abef54c-4f7c-4b61-8ed2-0a1627f3b20c 55138-004 HUMAN OTC DRUG Heartery American Ginseng, Arnica Montana, Gold, Barium Carbonate, Atropa Belladonna, Calcium Fluoride, Cholesterol, Herring Sperm DNA, Ginkgo, Saccharomyces Cerevisia RNA, Visbum Album Fruiting Top, and Ginger SPRAY ORAL 20131118 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. AMERICAN GINSENG; ARNICA MONTANA; ATROPA BELLADONNA; BARIUM CARBONATE; CALCIUM FLUORIDE; CHOLESTEROL; GINGER; GINKGO; GOLD; HERRING SPERM DNA; SACCHAROMYCES CEREVISIAE RNA; VISCUM ALBUM FRUITING TOP 1; 1.5; 3; 30; 6; 15; 30; 3; 30; 3; 3; 1.5 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL 55138-005_639874bb-c53d-40f1-bedb-4e8dcc84391e 55138-005 HUMAN OTC DRUG Diabetigen Arnica Montana, Arsenic Trioxide, Herring Sperm NDA, Echinacea, Unspecified, Hamamelis Virginiana Leaf, Chamaelirium Luteum Root, Pork Liver, Iris Versicolor Root, Sus Scrofa Pancreas, Phosphoric Acid, Rosmarinus Officinalis Flowering Top, Claviceps Purpurea Sclerotium, Syzygium Cumini Seed, and Uranyl Nitrate Hexahydrate SPRAY ORAL 20131118 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. ARNICA MONTANA; ARSENIC TRIOXIDE; CHAMAELIRIUM LUTEUM ROOT; CLAVICEPS PURPUREA SCLEROTIUM; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA LEAF; HERRING SPERM DNA; IRIS VERSICOLOR ROOT; PHOSPHORIC ACID; PORK LIVER; ROSMARINUS OFFICINALIS FLOWERING TOP; SUS SCROFA PANCREAS; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 1.5; 200; 1.5; 30; 1.5; 1.5; 3; 3; 200; 3; 1.5; 3; 1.5; 30 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL 55138-006_7ff867c7-85a7-4222-a4b9-dff98bd4ec5e 55138-006 HUMAN OTC DRUG Brain Power Semecarpus Anacardium Juice, Arnica Montana, Calcium Fluoride, Silybum Marianum Seed, Chincona Officinalis Bark, Herring Sperm DNA, Ginkgo, Egg Phospholipids, Achillea Millefolium, Phosphoric Acid, Saccharomyces Cerevisia RNA, Silicon Dioxide, and Zinc Sulphate Heptahydrate SPRAY ORAL 20131118 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. ACHILLEA MILLEFOLIUM; ARNICA MONTANA; CALCIUM FLUORIDE; CINCHONA OFFICINALIS BARK; EGG PHOSPHOLIPIDS; GINKGO; HERRING SPERM DNA; PHOSPHORIC ACID; SACCHAROMYCES CEREVISIAE RNA; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SILYBUM MARIANUM SEED OIL; ZINC SULFATE HEPTAHYDRATE 1.5; 1.5; 30; 3; 6; 3; 3; 30; 6; 30; 6; 1.5; 6 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL 55138-007_bba3f011-32e9-4c36-abad-d2f1630d31c8 55138-007 HUMAN OTC DRUG Livergen Arnica Montana, Byronia Alba Root, Silybum Marianum Seed, Chelidonium Majus, Herring Sperm DNA, Pork Liver, Cervus Elaphus Horn Oil, Sus Scrofa Pancreas, and Taraxacum Officinale SPRAY ORAL 20131113 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. ARNICA MONTANA; BRYONIA ALBA ROOT; CERVUS ELAPHUS HORN OIL; CHELIDONIUM MAJUS; HERRING SPERM DNA; PORK LIVER; SILYBUM MARIANUM SEED OIL; SUS SCROFA PANCREAS; TARAXACUM OFFICINALE 1.5; 200; 4; 200; 3; 3; .5; 4; 1 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL 55138-011_09714392-eccb-4123-a8f5-56f9d04009f3 55138-011 HUMAN OTC DRUG Lung Detox silver nitrate, arsenic trioxide, activated charcoal, silybum marianum seed, herring sperm DNA, pork liver, mercuric chloride, lead SPRAY ORAL 20140808 UNAPPROVED HOMEOPATHIC Integra Health International S.A. de C.V. ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; HERRING SPERM DNA; LEAD; MERCURIC CHLORIDE; PORK LIVER; SILVER NITRATE; SILYBUM MARIANUM SEED 200; 200; 3; 200; 200; 3; 200; .5 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg 55138-012_9cd1c9c0-ab97-408a-b64e-aabab0bf00cc 55138-012 HUMAN OTC DRUG Female Energy Chaste Tree, Arnica Montana, Caulophyllum Thalictroides Root, Cinchona Officinalis Bark, Turnera Diffusa Leafy Twig, Herring Sperm DNA, Lactuca Virosa, Onosmodium Virginianum Whole, Sus Scrofa Ovary, Phosphoric Acid, Sus Scrofa Pituitary Gland, Sepia Officinalis Juice, Thuja Occidentalis Leafy Twig SPRAY ORAL 20140807 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. ARNICA MONTANA; CAULOPHYLLUM THALICTROIDES ROOT; CHASTE TREE; CINCHONA OFFICINALIS BARK; HERRING SPERM DNA; LACTUCA VIROSA; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; TURNERA DIFFUSA LEAFY TWIG 1.5; 3; 1.5; 1.5; 3; 1.5; 30; 200; 30; 30; 6; 30; .5 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg 55138-013_0d9732a5-d779-4afa-bdeb-f2d261ab474b 55138-013 HUMAN OTC DRUG Male Tonicity american ginseng, arnica montana, turnera diffusa leafy twig, herring sperm DNA, galium aparine, hamamelis virginiana root bark/stem bark, pork liver, cervus elaphus horn oil, ovis aries testicle, phosphoric acid, sus scrofa pituitary gland, thuja occidentalis leafy twig, thyroid, unspecified, tribulus terrestris, ginger SPRAY ORAL 20140808 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. AMERICAN GINSENG; ARNICA MONTANA; CERVUS ELAPHUS HORN OIL; GALIUM APARINE; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HERRING SPERM DNA; OVIS ARIES TESTICLE; PHOSPHORIC ACID; PORK LIVER; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRIBULUS TERRESTRIS; TURNERA DIFFUSA LEAFY TWIG 1.5; 1.5; 4; 1.5; 1.5; 1.5; 3; 3; 200; 3; 4; 1.5; 6; 1; 1 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg 55143-009_e15e630d-49b1-404a-916d-53aae6888e6a 55143-009 HUMAN OTC DRUG BIRDS GARDEN LIP BALM CERULEAN WARBLER SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 7; 5 g/100g; g/100g; g/100g; g/100g 55143-010_9260c289-54ae-4eaf-b8f4-376959804993 55143-010 HUMAN OTC DRUG BIRDS GARDEN LIP BALM WESTERN TANAGER - SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 7; 5 g/100g; g/100g; g/100g; g/100g 55143-011_aa841284-14ed-4308-9569-925f6bce9e7a 55143-011 HUMAN OTC DRUG BIRDS GARDEN LIP BALM DARK EYED JUNCO SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 7; 5 g/100g; g/100g; g/100g; g/100g 55143-012_d23998ec-a3e9-4765-9a35-82216333c531 55143-012 HUMAN OTC DRUG Lip Remedy Medicinal Lip Balm BLUE PETROLATUM STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part346 Norwood Packaging Ltd. PETROLATUM 32.3 g/100g 55143-013_d23998ec-a3e9-4765-9a35-82216333c531 55143-013 HUMAN OTC DRUG Lip Remedy Medicinal Lip Balm GREEN PETROLATUM STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part346 Norwood Packaging Ltd. PETROLATUM 32.3 g/100g 55143-014_d23998ec-a3e9-4765-9a35-82216333c531 55143-014 HUMAN OTC DRUG Lip Remedy Medicinal Lip Balm RED PETROLATUM STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part346 Norwood Packaging Ltd. PETROLATUM 32.3 g/100g 55143-100_0d70e74f-76a1-4b7a-aa48-56301c458ea5 55143-100 HUMAN OTC DRUG Badger Lavender SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 18.75 g/100mL 55143-101_901c54cd-c747-4dda-9a1d-f55b7e36def0 55143-101 HUMAN OTC DRUG Badger SPF 35 All Season Face ZINC OXIDE STICK TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 22.5 g/100g 55143-102_4306291a-c8ea-4dd4-94a3-fb7ee261704b 55143-102 HUMAN OTC DRUG Badger Unscented SPF 15 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 10 g/100mL 55143-103_40043922-9aaf-4aac-983a-a20224ab6da3 55143-103 HUMAN OTC DRUG Badger SPF 34 Anti-Bug Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 20 g/100mL 55143-104_85e433f0-2da5-4638-a31e-78c1cab56950 55143-104 HUMAN OTC DRUG Badger Unscented SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 18.75 g/100mL 55143-105_17306c4f-fc16-463c-82e9-e47839c03ecd 55143-105 HUMAN OTC DRUG Badger Baby SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 18.75 g/100mL 55143-106_3ea8daa1-1221-46a4-afaf-2675d6b13876 55143-106 HUMAN OTC DRUG Badger Sport SPF 35 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 22.5 g/100mL 55143-107_014285da-cd1b-484a-a259-dcd787233cbe 55143-107 HUMAN OTC DRUG Badger Kids SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 18.75 g/100mL 55143-108_bd618a66-f9b9-43e9-8b92-b3db631b9067 55143-108 HUMAN OTC DRUG Badger SPF 15 Sunscreen Lip Balm ZINC OXIDE STICK TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 8 g/100g 55150-111_8cd7bcd7-032a-461c-857b-48b7dc9dd95f 55150-111 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120201 ANDA ANDA065499 AuroMedics Pharma LLC AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55150-112_8cd7bcd7-032a-461c-857b-48b7dc9dd95f 55150-112 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120201 ANDA ANDA065499 AuroMedics Pharma LLC AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55150-113_8cd7bcd7-032a-461c-857b-48b7dc9dd95f 55150-113 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120201 ANDA ANDA065499 AuroMedics Pharma LLC AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55150-114_8cd7bcd7-032a-461c-857b-48b7dc9dd95f 55150-114 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120201 ANDA ANDA065499 AuroMedics Pharma LLC AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55150-115_34c77e60-9b81-49fc-9bcf-fb3f1e388d38 55150-115 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120201 ANDA ANDA065493 AuroMedics Pharma LLC AMPICILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55150-116_2dc5e84d-4272-4dd5-9bac-b59ae0437704 55150-116 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120210 ANDA ANDA090349 AuroMedics Pharma LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 55150-117_2dc5e84d-4272-4dd5-9bac-b59ae0437704 55150-117 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120210 ANDA ANDA090349 AuroMedics Pharma LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 55150-118_cee45810-c747-44d8-8764-9f9f7ee1fda6 55150-118 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120210 ANDA ANDA090339 AuroMedics Pharma LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 100; 50 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 55150-119_966581b3-9151-4700-bbf1-8f63f87748ef 55150-119 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin Sodium and Tazobactam Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120123 ANDA ANDA065498 AuroMedics Pharma LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 55150-120_966581b3-9151-4700-bbf1-8f63f87748ef 55150-120 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin Sodium and Tazobactam Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120123 ANDA ANDA065498 AuroMedics Pharma LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 55150-121_966581b3-9151-4700-bbf1-8f63f87748ef 55150-121 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin Sodium and Tazobactam Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120123 ANDA ANDA065498 AuroMedics Pharma LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 55150-122_e31685cd-5b05-4c97-a668-e51c6277e47d 55150-122 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121226 ANDA ANDA091613 AuroMedics Pharma LLC NAFCILLIN SODIUM 1 g/4mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55150-123_34821770-929c-40ea-a9e4-d4405dc869e1 55150-123 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121226 ANDA ANDA091613 AuroMedics Pharma LLC NAFCILLIN SODIUM 2 g/8mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55150-123_e31685cd-5b05-4c97-a668-e51c6277e47d 55150-123 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121226 ANDA ANDA091613 AuroMedics Pharma LLC NAFCILLIN SODIUM 2 g/8mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55150-124_0f21384c-0f82-4d99-a05c-6773d1ee4bcf 55150-124 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121226 ANDA ANDA091614 AuroMedics Pharma LLC NAFCILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55150-124_1d0773c4-4cb3-4bc3-aa46-029921514108 55150-124 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121226 ANDA ANDA091614 AuroMedics Pharma LLC NAFCILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55150-125_bccc173d-2c94-45bf-a6a1-1c50857dfb03 55150-125 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121221 ANDA ANDA202600 AuroMedics Pharma LLC ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55150-126_97f669ba-1461-4d0b-9f62-d03002b63b57 55150-126 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121221 ANDA ANDA202599 AuroMedics Pharma LLC ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55150-127_785edf6a-6f96-42f9-84b9-9b15ddf05de7 55150-127 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130118 ANDA ANDA201539 AuroMedics Pharma LLC OXACILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55150-128_785edf6a-6f96-42f9-84b9-9b15ddf05de7 55150-128 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130118 ANDA ANDA201539 AuroMedics Pharma LLC OXACILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55150-129_2edb984c-4346-431f-b452-5aa2f1672cb1 55150-129 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin Sodium POWDER, FOR SOLUTION INTRAVENOUS 20130118 ANDA ANDA201538 AuroMedics Pharma LLC OXACILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55150-129_b0a443a8-05d2-44bc-a150-58526b7f05f6 55150-129 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin Sodium POWDER, FOR SOLUTION INTRAVENOUS 20130118 ANDA ANDA201538 AuroMedics Pharma LLC OXACILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55150-154_b9297388-0f4a-4b4c-b42d-52bcc24f669c 55150-154 HUMAN PRESCRIPTION DRUG Acyclovir Sodium Acyclovir Sodium INJECTION, SOLUTION INTRAVENOUS 20131011 ANDA ANDA203701 AuroMedics Pharma LLC ACYCLOVIR SODIUM 500 mg/10mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55150-154_d3ab226c-677d-4cb7-85cb-1c2e5012f40d 55150-154 HUMAN PRESCRIPTION DRUG Acyclovir Sodium Acyclovir Sodium INJECTION, SOLUTION INTRAVENOUS 20131011 ANDA ANDA203701 AuroMedics Pharma LLC ACYCLOVIR SODIUM 500 mg/10mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55150-155_b9297388-0f4a-4b4c-b42d-52bcc24f669c 55150-155 HUMAN PRESCRIPTION DRUG Acyclovir Sodium Acyclovir Sodium INJECTION, SOLUTION INTRAVENOUS 20131011 ANDA ANDA203701 AuroMedics Pharma LLC ACYCLOVIR SODIUM 1000 mg/20mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55150-155_d3ab226c-677d-4cb7-85cb-1c2e5012f40d 55150-155 HUMAN PRESCRIPTION DRUG Acyclovir Sodium Acyclovir Sodium INJECTION, SOLUTION INTRAVENOUS 20131011 ANDA ANDA203701 AuroMedics Pharma LLC ACYCLOVIR SODIUM 1000 mg/20mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55150-156_4038a1a3-cb4c-4724-bcbc-e5ffccb43c42 55150-156 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130124 ANDA ANDA202328 AuroMedics Pharma LLC LEVOFLOXACIN 500 mg/20mL 55150-157_4038a1a3-cb4c-4724-bcbc-e5ffccb43c42 55150-157 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130124 ANDA ANDA202328 AuroMedics Pharma LLC LEVOFLOXACIN 750 mg/30mL 55150-158_48b975bf-13d2-4d4a-b57e-28e1c0ec012c 55150-158 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20130314 ANDA ANDA203040 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55150-159_48b975bf-13d2-4d4a-b57e-28e1c0ec012c 55150-159 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20130314 ANDA ANDA203040 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55150-160_48b975bf-13d2-4d4a-b57e-28e1c0ec012c 55150-160 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20130314 ANDA ANDA203040 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55150-161_6e5d5636-4129-4544-ac37-e66c8b489ad4 55150-161 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20130314 ANDA ANDA203082 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55150-162_6e5d5636-4129-4544-ac37-e66c8b489ad4 55150-162 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20130314 ANDA ANDA203082 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55150-163_6e5d5636-4129-4544-ac37-e66c8b489ad4 55150-163 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20130314 ANDA ANDA203082 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55150-164_6e5d5636-4129-4544-ac37-e66c8b489ad4 55150-164 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20130314 ANDA ANDA203082 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55150-165_6e5d5636-4129-4544-ac37-e66c8b489ad4 55150-165 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20130314 ANDA ANDA203082 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55150-167_f8ec86f0-0677-40f0-8305-8bb694ffdab5 55150-167 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 20131105 ANDA ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 55150-168_f8ec86f0-0677-40f0-8305-8bb694ffdab5 55150-168 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 20131105 ANDA ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 55150-169_f8ec86f0-0677-40f0-8305-8bb694ffdab5 55150-169 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INTRACAUDAL 20131105 ANDA ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 55150-170_f8ec86f0-0677-40f0-8305-8bb694ffdab5 55150-170 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INTRACAUDAL 20131105 ANDA ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 55150-171_f8ec86f0-0677-40f0-8305-8bb694ffdab5 55150-171 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; RETROBULBAR 20131105 ANDA ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 55150-172_f8ec86f0-0677-40f0-8305-8bb694ffdab5 55150-172 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; RETROBULBAR 20131105 ANDA ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 55150-173_200f721e-fcbc-4ded-9912-1c729c012838 55150-173 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan INJECTION, SOLUTION SUBCUTANEOUS 20130423 ANDA ANDA202758 AuroMedics Pharma LLC SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 55150-178_17c8a956-fbda-46d2-8b34-cd665b8e2830 55150-178 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120913 ANDA ANDA090340 AuroMedics Pharma LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 55150-179_17c8a956-fbda-46d2-8b34-cd665b8e2830 55150-179 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120913 ANDA ANDA090340 AuroMedics Pharma LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 55151-123_21963db4-acde-492b-8242-75b5394a198f 55151-123 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20110101 UNAPPROVED MEDICAL GAS E-Z Oxygen LLC, dba AO2 OXYGEN 99 L/100L 55154-0082_00f1a642-3350-43fb-9efb-2d7bb2555ace 55154-0082 HUMAN PRESCRIPTION DRUG TRUVADA emtricitabine and tenofovir disoproxil fumarate TABLET ORAL 20040802 NDA NDA021752 Cardinal Health EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 55154-0103_b2ccc7c8-e43e-42b8-96bb-114989ea972a 55154-0103 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110908 NDA NDA018803 Cardinal Health SODIUM CHLORIDE 9 mg/mL 55154-0109_cb72ed2c-f674-4b63-98c3-1e43b52ce11f 55154-0109 HUMAN PRESCRIPTION DRUG Biaxin Clarithromycin TABLET, FILM COATED ORAL 19911031 NDA NDA050662 Cardinal Health CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 55154-0113_422faa3e-5c25-438d-866b-791664be6d05 55154-0113 HUMAN PRESCRIPTION DRUG Depakote divalproex sodium CAPSULE ORAL 20100607 NDA NDA019680 Cardinal Health DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-0119_1c70c967-d9d5-4bf9-a4ed-76336d93e449 55154-0119 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 19850418 UNAPPROVED DRUG OTHER Cardinal Health SODIUM BICARBONATE 84 mg/mL 55154-0120_c9f994ab-ea02-4689-ae4d-eb11fa6035db 55154-0120 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110727 ANDA ANDA074802 Cardinal Health KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-0124_afd7c91b-3283-49e7-b79f-1c8d0c1a53bd 55154-0124 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA088299 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-0126_107af8bc-b6af-4b85-8c8a-ea757dcef1da 55154-0126 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110908 NDA NDA018803 Cardinal Health SODIUM CHLORIDE 9 mg/mL 55154-0127_1199866b-b94c-4eec-9397-cf8683e7c73a 55154-0127 HUMAN PRESCRIPTION DRUG Sterile Water WATER INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110915 NDA NDA018801 Cardinal Health WATER 10 mL/10mL 55154-0130_00284029-6e70-430e-adea-c5bde6a9860e 55154-0130 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110727 ANDA ANDA074802 Cardinal Health KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-0131_f5796847-cc98-4f53-8b1b-0e3ef4ded1ef 55154-0131 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA080408 Cardinal Health LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-0132_77fd6ee4-108f-4525-8df5-7db9236042ee 55154-0132 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine lidocaine hydrochloride anhydrous and epinephrine INJECTION, SOLUTION INFILTRATION 20100405 ANDA ANDA089644 Cardinal Health EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 10; 10 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-0134_00284029-6e70-430e-adea-c5bde6a9860e 55154-0134 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110727 ANDA ANDA074802 Cardinal Health KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-0147_ab1436e1-40af-493a-b548-8773a0ffe40c 55154-0147 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION EPIDURAL; INFILTRATION 20100330 ANDA ANDA088329 Cardinal Health LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-0149_c9f994ab-ea02-4689-ae4d-eb11fa6035db 55154-0149 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 20110727 ANDA ANDA074802 Cardinal Health KETOROLAC TROMETHAMINE 60 mg/2mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-0154_7cdef849-0c70-4843-8f6d-ed7377a25ebd 55154-0154 HUMAN OTC DRUG White petrolatum White petrolatum OINTMENT TOPICAL 20110620 OTC MONOGRAPH FINAL part347 Cardinal Health PETROLATUM 5 g/1 55154-0155_53149ddf-f61b-4b31-8803-4bdb77898b0b 55154-0155 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health BACITRACIN 500 1/1 55154-0156_5d9c22fc-7686-49d0-a4eb-ce3efcd5ab02 55154-0156 HUMAN OTC DRUG Triple Antibiotic Neomycin, Polymyxin B Sulfates, Bacitracin OINTMENT TOPICAL 20110606 UNAPPROVED DRUG OTHER Cardinal Health BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/1; mg/1; [USP'U]/1 55154-0157_1ba99ccb-4e36-406b-8f90-a375ea945305 55154-0157 HUMAN OTC DRUG Vitamin A and Vitamin D Vitamin A and Vitamin D OINTMENT TOPICAL 19810101 OTC MONOGRAPH FINAL part347 Cardinal Health PETROLATUM 929.3 mg/g 55154-0216_29bc19b7-eb77-4b30-a4f8-e6d4627ddd01 55154-0216 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Cardinal Health ESTROGENS, CONJUGATED .625 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 55154-0217_29bc19b7-eb77-4b30-a4f8-e6d4627ddd01 55154-0217 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Cardinal Health ESTROGENS, CONJUGATED .3 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 55154-0218_29bc19b7-eb77-4b30-a4f8-e6d4627ddd01 55154-0218 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Cardinal Health ESTROGENS, CONJUGATED .45 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 55154-0219_29bc19b7-eb77-4b30-a4f8-e6d4627ddd01 55154-0219 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Cardinal Health ESTROGENS, CONJUGATED .9 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] 55154-0253_6b4394e4-4fca-4757-8cf4-645dccb5d6d5 55154-0253 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20020830 NDA NDA021428 Cardinal Health LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55154-0328_1c392554-bc9b-4931-84b8-15d2718e666b 55154-0328 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Cardinal Health ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-0352_c39a2b09-f3c6-4660-b7de-77b3829c0dd3 55154-0352 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20000621 ANDA ANDA075421 Cardinal Health MIDAZOLAM HYDROCHLORIDE 2 mg/2mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-0353_c39a2b09-f3c6-4660-b7de-77b3829c0dd3 55154-0353 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20000621 ANDA ANDA075421 Cardinal Health MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-0354_4f092ea9-e411-4936-8fe3-b219b1276aee 55154-0354 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20000621 ANDA ANDA075421 Cardinal Health MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-0355_24878502-9383-4c4f-903c-8895fda20742 55154-0355 HUMAN PRESCRIPTION DRUG Enalaprilat Enalaprilat INJECTION INTRAVENOUS 20000823 ANDA ANDA075634 Cardinal Health ENALAPRILAT 1.25 mg/mL Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55154-0357_50b898a5-9fbc-4a30-bafb-8888957de531 55154-0357 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol lactate INJECTION INTRAMUSCULAR 20010619 ANDA ANDA075858 Cardinal Health HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] 55154-0358_d782a0e3-feb6-4f39-b509-5f8bc71a6d6c 55154-0358 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide INJECTION INTRAMUSCULAR; INTRAVENOUS 19950301 ANDA ANDA074441 Cardinal Health BUMETANIDE .25 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-0359_c39a2b09-f3c6-4660-b7de-77b3829c0dd3 55154-0359 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20000621 ANDA ANDA075421 Cardinal Health MIDAZOLAM HYDROCHLORIDE 10 mg/2mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-0365_c81ec366-538d-4341-a4f4-163910e55202 55154-0365 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20000801 ANDA ANDA075549 Cardinal Health VECURONIUM BROMIDE 1 mg/mL 55154-0366_d0b63ffd-4644-4ed4-89e3-d068141e5a55 55154-0366 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate Butorphanol Tartrate INJECTION INTRAMUSCULAR; INTRAVENOUS 19981015 ANDA ANDA075045 Cardinal Health BUTORPHANOL TARTRATE 2 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV 55154-0367_d0b63ffd-4644-4ed4-89e3-d068141e5a55 55154-0367 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate Butorphanol Tartrate INJECTION INTRAMUSCULAR; INTRAVENOUS 19981015 ANDA ANDA075045 Cardinal Health BUTORPHANOL TARTRATE 1 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV 55154-0368_d7b2ef1f-3a0b-4ccc-b971-41cc5375d083 55154-0368 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19990426 ANDA ANDA075222 Cardinal Health KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-0369_d7b2ef1f-3a0b-4ccc-b971-41cc5375d083 55154-0369 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19990426 ANDA ANDA075222 Cardinal Health KETOROLAC TROMETHAMINE 60 mg/2mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-0370_41450582-de48-4b9b-ab59-6cd1004b93b9 55154-0370 HUMAN PRESCRIPTION DRUG Prochlorperazine Edisylate Prochlorperazine Edisylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20040726 ANDA ANDA040540 Cardinal Health PROCHLORPERAZINE EDISYLATE 5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-0373_903d2fe0-87b7-43f8-98a4-693f61f9e6b5 55154-0373 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 20080505 ANDA ANDA076495 Cardinal Health METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-0375_c4a37c22-ef8d-48d8-a9da-dafb5c06ecdb 55154-0375 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090722 ANDA ANDA065465 Cardinal Health CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-0407_ffd8c563-275f-4942-839e-12457080ca1b 55154-0407 HUMAN PRESCRIPTION DRUG Flomax tamsulosin hydrochloride CAPSULE ORAL 19970912 NDA NDA020579 Cardinal Health TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55154-0409_d0eb3c2e-4376-48e1-a666-bb5df5db898e 55154-0409 HUMAN PRESCRIPTION DRUG Mirapex pramipexole dihydrochloride TABLET ORAL 20040101 NDA NDA020667 Cardinal Health PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55154-0410_dfe327e8-f6ab-41e5-bdef-d520118cd83a 55154-0410 HUMAN PRESCRIPTION DRUG Tradjenta linagliptin TABLET, FILM COATED ORAL 20110509 NDA NDA201280 Cardinal Health LINAGLIPTIN 5 mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC] 55154-0452_ae32576e-c29b-4dbc-9055-4821a1dc696e 55154-0452 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101209 NDA NDA017862 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 55154-0454_3352c7d0-e621-46ed-9a54-e4a9583cde10 55154-0454 HUMAN PRESCRIPTION DRUG Norepinephrine bitartrate Norepinephrine bitartrate INJECTION INTRAVENOUS 20030303 ANDA ANDA040455 Cardinal Health NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-0455_6c1ebb9f-a07c-4d6e-b51f-0cd30633a5f7 55154-0455 HUMAN PRESCRIPTION DRUG Promethazine promethazine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20020822 ANDA ANDA040454 Cardinal Health PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-0457_8612dabd-1d54-494b-b557-97f5c86f4c1d 55154-0457 HUMAN PRESCRIPTION DRUG vecuronium bromide vecuronium bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19990825 ANDA ANDA074688 Cardinal Health VECURONIUM BROMIDE 10 mg/10mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 55154-0459_c3606f13-ff90-46f2-a4bb-194e49ce7349 55154-0459 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol INJECTION INTRAMUSCULAR 20010829 ANDA ANDA076035 Cardinal Health HALOPERIDOL 5 mg/mL Typical Antipsychotic [EPC] 55154-0525_b8f21807-a9e1-4195-8d54-1bea404d429c 55154-0525 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 19960718 NDA AUTHORIZED GENERIC NDA050711 Cardinal Health AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55154-0527_702f044a-cefa-4789-8f1f-c213e6484b44 55154-0527 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Cardinal Health SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-0532_702f044a-cefa-4789-8f1f-c213e6484b44 55154-0532 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Cardinal Health SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-0533_59d012e5-4aca-402e-bfcd-d6c161ee0752 55154-0533 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate medroxyprogesterone acetate TABLET ORAL 19590603 NDA AUTHORIZED GENERIC NDA011839 Cardinal Health MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 55154-0534_73090d43-9f7a-478c-a36f-165df57982d0 55154-0534 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 19940426 NDA NDA020329 Cardinal Health GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55154-0535_b68de00a-4646-45f9-b4cf-cb295de3f1b3 55154-0535 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 19920731 NDA NDA019787 Cardinal Health AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-0536_3b5fa52d-4ff4-4e3a-9367-792c57a6e4de 55154-0536 HUMAN PRESCRIPTION DRUG donepezil hydrochloride DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 19961126 NDA NDA020690 Cardinal Health DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55154-0537_6b70d029-2c96-4c03-85de-28003f92ea55 55154-0537 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 19600915 NDA AUTHORIZED GENERIC NDA012462 Cardinal Health ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 55154-0539_32342d28-ea0f-47a6-beac-54dcefe8fea5 55154-0539 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 19940426 NDA NDA020329 Cardinal Health GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55154-0553_4a7e3723-9842-45b6-b24e-e3c800247f71 55154-0553 HUMAN PRESCRIPTION DRUG ELMIRON PENTOSAN POLYSULFATE SODIUM CAPSULE, GELATIN COATED ORAL 19960926 NDA NDA020193 Cardinal Health PENTOSAN POLYSULFATE SODIUM 100 mg/1 Glycosaminoglycan [EPC],Glycosaminoglycans [Chemical/Ingredient] 55154-0611_aa15c4cd-ab38-488c-809a-e46256a53198 55154-0611 HUMAN PRESCRIPTION DRUG ONGLYZA SAXAGLIPTIN TABLET, FILM COATED ORAL 20090731 NDA NDA022350 Cardinal Health SAXAGLIPTIN HYDROCHLORIDE 5 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 55154-0625_fd2e5de5-ad6f-4643-9600-2f5f8787125a 55154-0625 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100629 NDA NDA020381 Cardinal Health NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 55154-0626_fd2e5de5-ad6f-4643-9600-2f5f8787125a 55154-0626 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100629 NDA NDA020381 Cardinal Health NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 55154-0657_ef5eeb8a-e72c-42fb-b4e4-8f1b7098e940 55154-0657 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20040203 ANDA ANDA071655 Cardinal Health OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-0659_39ba9b84-6d4d-45f0-a798-e8bb53159d00 55154-0659 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20040203 ANDA ANDA071524 Cardinal Health TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 55154-0660_275de35f-7cb8-4043-8357-f17eef534224 55154-0660 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20090811 ANDA ANDA076899 Cardinal Health SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 55154-0661_c2b1777b-bb49-4103-9bfa-0ba04310d2a2 55154-0661 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl CAPSULE ORAL 20110726 UNAPPROVED DRUG OTHER Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 55154-0663_045c7732-1928-4a58-b5f5-a0a25543a476 55154-0663 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19980808 ANDA ANDA070027 Cardinal Health METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 55154-0667_845b2480-0ecc-4923-8f04-30cc5873eda5 55154-0667 HUMAN OTC DRUG DOK Docusate Sodium CAPSULE ORAL 20110606 UNAPPROVED DRUG OTHER Cardinal Health DOCUSATE SODIUM 100 mg/1 55154-0669_0e17eca4-f7d1-4ac1-b17f-364ff57c644e 55154-0669 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110603 UNAPPROVED DRUG OTHER Cardinal Health IBUPROFEN 200 mg/1 55154-0671_002aba09-f6af-48e8-9951-949e1033fb09 55154-0671 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 19870109 ANDA ANDA071450 Cardinal Health ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 55154-0672_42bc2552-3c8c-47c9-aa4f-2487096f4a2a 55154-0672 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 20040216 ANDA ANDA075191 Cardinal Health PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 55154-0673_39ba9b84-6d4d-45f0-a798-e8bb53159d00 55154-0673 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20040203 ANDA ANDA071524 Cardinal Health TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 55154-0674_1aa0862b-2d43-4fc1-b5ba-96559d268ab3 55154-0674 HUMAN OTC DRUG Bisacodyl Bisacodyl TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health BISACODYL 5 mg/1 55154-0676_98c778f9-5a3d-4b4f-9c9e-8a5f0b84b2a6 55154-0676 HUMAN PRESCRIPTION DRUG K-Vescent Efffervescent Potassium Bicarbonate TABLET, EFFERVESCENT ORAL 20050422 UNAPPROVED DRUG OTHER Cardinal Health POTASSIUM BICARBONATE 25 meq/1 55154-0677_946133ff-67c8-4d3f-8dd4-6d1e72f87f1d 55154-0677 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100715 ANDA ANDA072234 Cardinal Health BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 55154-0680_87081889-4951-42fa-9124-55467274ee81 55154-0680 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20110519 ANDA ANDA073618 Cardinal Health CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 55154-0681_54d75263-cbbb-4f92-b836-947cce9b504d 55154-0681 HUMAN OTC DRUG Senna-Lax Sennosides TABLET ORAL 20110603 UNAPPROVED DRUG OTHER Cardinal Health SENNOSIDES 8.6 mg/1 55154-0683_f9ac9f69-7bf8-4b3d-8c78-838dca14c64c 55154-0683 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl CAPSULE ORAL 20110603 UNAPPROVED DRUG OTHER Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55154-0685_6970cfc5-01c1-4108-9fe1-1a416992ba7b 55154-0685 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20061120 ANDA ANDA070974 Cardinal Health CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55154-0688_4098891b-889a-445e-9251-d80b3b90b991 55154-0688 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20040214 ANDA ANDA075356 Cardinal Health PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-0689_c9eec582-a6fa-4d67-93d4-658054cc55db 55154-0689 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20040216 ANDA ANDA074505 Cardinal Health CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-0693_c9eec582-a6fa-4d67-93d4-658054cc55db 55154-0693 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20040216 ANDA ANDA074505 Cardinal Health CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-0695_756adc68-e145-4163-bee5-6db7ca0579d8 55154-0695 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070995 Cardinal Health VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-0696_c25caca1-ccb9-4100-b01b-cc432a29375a 55154-0696 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20020813 ANDA ANDA072265 Cardinal Health BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 55154-0697_87081889-4951-42fa-9124-55467274ee81 55154-0697 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20110519 ANDA ANDA073618 Cardinal Health CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 55154-0701_7361f79a-3368-4cf0-9e6c-4093517646c8 55154-0701 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 19970930 NDA NDA020405 Cardinal Health DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 55154-0702_212024b4-06a2-44cd-a562-9ad37b59259a 55154-0702 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 19970930 NDA NDA020405 Cardinal Health DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 55154-0727_ed356600-1b7e-418f-8f91-cece10a6ff7a 55154-0727 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20091120 ANDA ANDA074410 Cardinal Health NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-0732_c9eec582-a6fa-4d67-93d4-658054cc55db 55154-0732 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20040216 ANDA ANDA074505 Cardinal Health CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-0733_0b8e1f0c-cb10-4a9c-83ed-7cd062c9f6d1 55154-0733 HUMAN OTC DRUG DOK Plus DOK Plus TABLET ORAL 20110607 UNAPPROVED DRUG OTHER Cardinal Health DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 55154-0734_eb277358-0db6-4737-a1dd-c1f13b4a883a 55154-0734 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 20040216 ANDA ANDA072423 Cardinal Health MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 55154-0736_4098891b-889a-445e-9251-d80b3b90b991 55154-0736 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20040214 ANDA ANDA075356 Cardinal Health PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-0741_926bb322-a23b-4cc6-80ee-868f2c565c4e 55154-0741 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Cardinal Health IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-0743_6c54da68-f346-4ec6-b8a8-0297c1e91d18 55154-0743 HUMAN OTC DRUG Senna Plus standardized senna concentrate and docusate sodium TABLET ORAL 20100114 UNAPPROVED DRUG OTHER Cardinal Health DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 55154-0745_ab64d520-a4fd-411d-b1ea-31fd602dccd4 55154-0745 HUMAN OTC DRUG Mapap Extra Strength Mapap Extra Strength TABLET ORAL 20110527 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 500 mg/1 55154-0746_09fa3328-97a4-4c8f-a695-9578c7925af9 55154-0746 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110531 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 500 mg/1 55154-0748_81e60097-7416-498d-9f24-b29362b4f7c5 55154-0748 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20110523 UNAPPROVED DRUG OTHER Cardinal Health ASPIRIN 81 mg/1 55154-0828_12c48560-20f6-4f2a-a4f3-d2b92acdaee1 55154-0828 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 19971031 ANDA ANDA075079 Cardinal Health OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-0832_ab17d24a-57af-4d8d-ae01-7e6846107373 55154-0832 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030827 ANDA ANDA040511 Cardinal Health ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 55154-0837_2dae31fb-ec34-4c2a-beac-61ce1533a946 55154-0837 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-0840_2dae31fb-ec34-4c2a-beac-61ce1533a946 55154-0840 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-0841_e18c62bc-bd52-4928-86f7-9a9345cf4a24 55154-0841 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Cardinal Health METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55154-0842_e18c62bc-bd52-4928-86f7-9a9345cf4a24 55154-0842 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Cardinal Health METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55154-0843_bd2d8de6-3159-4d93-9043-240ddc2bf396 55154-0843 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20100604 ANDA ANDA040756 Cardinal Health FOLIC ACID 1 mg/1 55154-0844_ac33601b-743b-41ab-8530-b2b59fad1dc4 55154-0844 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20060510 ANDA ANDA077754 Cardinal Health LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-0845_ac33601b-743b-41ab-8530-b2b59fad1dc4 55154-0845 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20060510 ANDA ANDA077754 Cardinal Health LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-0876_02fddbda-e9e1-41f0-b1a9-b46f4f24705c 55154-0876 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20100329 ANDA ANDA040145 Cardinal Health WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-0877_02fddbda-e9e1-41f0-b1a9-b46f4f24705c 55154-0877 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20100329 ANDA ANDA040145 Cardinal Health WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-0878_02fddbda-e9e1-41f0-b1a9-b46f4f24705c 55154-0878 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20100329 ANDA ANDA040145 Cardinal Health WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-0879_02fddbda-e9e1-41f0-b1a9-b46f4f24705c 55154-0879 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20100329 ANDA ANDA040145 Cardinal Health WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-0880_02fddbda-e9e1-41f0-b1a9-b46f4f24705c 55154-0880 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20100329 ANDA ANDA040145 Cardinal Health WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-0883_02fddbda-e9e1-41f0-b1a9-b46f4f24705c 55154-0883 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20100329 ANDA ANDA040145 Cardinal Health WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-0884_02fddbda-e9e1-41f0-b1a9-b46f4f24705c 55154-0884 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20100329 ANDA ANDA040145 Cardinal Health WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-0885_60d6eac9-1353-4829-8a8f-ba06b412d5b2 55154-0885 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19951130 ANDA ANDA074621 Cardinal Health MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 55154-0903_d070418d-fdea-4c34-8c3d-550f67003914 55154-0903 HUMAN PRESCRIPTION DRUG SYNTHROID levothyroxine sodium tablets TABLET ORAL 20020724 NDA NDA021402 Cardinal Health LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-0904_d070418d-fdea-4c34-8c3d-550f67003914 55154-0904 HUMAN PRESCRIPTION DRUG SYNTHROID levothyroxine sodium tablets TABLET ORAL 20020724 NDA NDA021402 Cardinal Health LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-0905_d070418d-fdea-4c34-8c3d-550f67003914 55154-0905 HUMAN PRESCRIPTION DRUG SYNTHROID levothyroxine sodium tablets TABLET ORAL 20020724 NDA NDA021402 Cardinal Health LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-0906_d070418d-fdea-4c34-8c3d-550f67003914 55154-0906 HUMAN PRESCRIPTION DRUG SYNTHROID levothyroxine sodium tablets TABLET ORAL 20020724 NDA NDA021402 Cardinal Health LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-0907_d070418d-fdea-4c34-8c3d-550f67003914 55154-0907 HUMAN PRESCRIPTION DRUG SYNTHROID levothyroxine sodium tablets TABLET ORAL 20020224 NDA NDA021402 Cardinal Health LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-0908_d070418d-fdea-4c34-8c3d-550f67003914 55154-0908 HUMAN PRESCRIPTION DRUG SYNTHROID levothyroxine sodium tablets TABLET ORAL 20020724 NDA NDA021402 Cardinal Health LEVOTHYROXINE SODIUM 300 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-0909_d070418d-fdea-4c34-8c3d-550f67003914 55154-0909 HUMAN PRESCRIPTION DRUG SYNTHROID levothyroxine sodium tablets TABLET ORAL 20020724 NDA NDA021402 Cardinal Health LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-0910_d070418d-fdea-4c34-8c3d-550f67003914 55154-0910 HUMAN PRESCRIPTION DRUG SYNTHROID levothyroxine sodium tablets TABLET ORAL 20020724 NDA NDA021402 Cardinal Health LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-0911_d070418d-fdea-4c34-8c3d-550f67003914 55154-0911 HUMAN PRESCRIPTION DRUG SYNTHROID levothyroxine sodium tablets TABLET ORAL 20020724 NDA NDA021402 Cardinal Health LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-0913_d070418d-fdea-4c34-8c3d-550f67003914 55154-0913 HUMAN PRESCRIPTION DRUG SYNTHROID levothyroxine sodium tablets TABLET ORAL 20020724 NDA NDA021402 Cardinal Health LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-0914_d070418d-fdea-4c34-8c3d-550f67003914 55154-0914 HUMAN PRESCRIPTION DRUG SYNTHROID levothyroxine sodium tablets TABLET ORAL 20020724 NDA NDA021402 Cardinal Health LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-0925_e050c403-5410-464d-8b28-2b964ae45a59 55154-0925 HUMAN PRESCRIPTION DRUG Ephedrine Sulfate Ephedrine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20040326 20150228 UNAPPROVED DRUG OTHER Cardinal Health EPHEDRINE SULFATE 50 mg/mL 55154-0975_46f787bf-742b-441b-bbb0-e5bc0d5efea4 55154-0975 HUMAN PRESCRIPTION DRUG PROVIGIL modafinil TABLET ORAL 19981224 NDA NDA020717 Cardinal Health MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 55154-1025_63e5ec33-11ad-40fc-b5c6-059cba25f9f6 55154-1025 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 Cardinal Health SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-1026_63e5ec33-11ad-40fc-b5c6-059cba25f9f6 55154-1026 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 Cardinal Health SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-1027_63e5ec33-11ad-40fc-b5c6-059cba25f9f6 55154-1027 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 Cardinal Health SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-1028_4f75d11d-7299-4813-9692-5e480f0ccaa4 55154-1028 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Cardinal Health AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-1029_4f75d11d-7299-4813-9692-5e480f0ccaa4 55154-1029 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Cardinal Health AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-1032_7cfef027-9810-4494-882a-9c53eff86364 55154-1032 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20120120 ANDA ANDA078457 Cardinal Health QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-1054_d598f95b-92dd-4ef5-ae97-d68972258e44 55154-1054 HUMAN PRESCRIPTION DRUG AZACTAM AZTREONAM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090601 NDA NDA050580 Cardinal Health AZTREONAM 1 g/1 Monobactam Antibacterial [EPC],Monobactams [Chemical/Ingredient] 55154-1056_2a974496-ac11-44ff-82c2-f541e7ed30d9 55154-1056 HUMAN PRESCRIPTION DRUG MAXIPIME CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19960118 NDA NDA050679 Cardinal Health CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-1057_2a974496-ac11-44ff-82c2-f541e7ed30d9 55154-1057 HUMAN PRESCRIPTION DRUG MAXIPIME CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19960118 NDA NDA050679 Cardinal Health CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-1081_06f3a056-09c3-495d-baad-ce5fb2ca8532 55154-1081 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970829 ANDA ANDA074979 Cardinal Health CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-1106_11033b25-5edb-4312-925a-615a0aaa8701 55154-1106 HUMAN PRESCRIPTION DRUG ZANTAC ranitidine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19891001 NDA NDA019090 Cardinal Health RANITIDINE HYDROCHLORIDE 25 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55154-1113_56e00590-62cd-4d69-a90e-7ebf1597f9a0 55154-1113 HUMAN PRESCRIPTION DRUG LANOXIN digoxin INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19851001 NDA NDA009330 Cardinal Health DIGOXIN 250 ug/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 55154-1114_14bfdedd-040b-4973-948d-4b11e861d506 55154-1114 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 19950801 NDA NDA020487 Cardinal Health VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55154-1115_212024b4-06a2-44cd-a562-9ad37b59259a 55154-1115 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 19970930 NDA NDA020405 Cardinal Health DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 55154-1124_c2f45307-dacb-40cc-aa33-ed57790b0079 55154-1124 HUMAN OTC DRUG Acephen Acetaminophen SUPPOSITORY RECTAL 20110606 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 325 mg/1 55154-1125_fd2fa2af-5929-4152-afd3-55e4e162f765 55154-1125 HUMAN PRESCRIPTION DRUG FORTAZ ceftazidime INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19920826 NDA NDA050578 Cardinal Health CEFTAZIDIME SODIUM 20 mg/mL 55154-1132_3c327aa6-a790-4262-a79b-51856976d560 55154-1132 HUMAN PRESCRIPTION DRUG ZOFRAN ondansetron hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 19990127 NDA NDA020781 Cardinal Health ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-1133_fcb4359f-7fac-4357-b9b7-e956f533f9b6 55154-1133 HUMAN PRESCRIPTION DRUG MEPRON atovaquone SUSPENSION ORAL 19980918 NDA NDA020500 Cardinal Health ATOVAQUONE 750 mg/5mL Antimalarial [EPC],Antiprotozoal [EPC] 55154-1134_c41a930c-8678-4460-8e95-4e84309fe069 55154-1134 HUMAN PRESCRIPTION DRUG LOVAZA omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20081021 NDA NDA021654 Cardinal Health OMEGA-3-ACID ETHYL ESTERS 1 g/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] 55154-1150_1c7ff5b9-6698-4e8c-9060-2abcd3fb0dcf 55154-1150 HUMAN PRESCRIPTION DRUG Norco Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19970214 ANDA ANDA040148 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-1175_9a1522ff-e0cc-4f7d-88c5-f052d1dfbc8c 55154-1175 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Cardinal Health SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 55154-1176_4f5ff837-fea7-4f3e-a5cd-91653dd0506d 55154-1176 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Cardinal Health IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-1177_4f5ff837-fea7-4f3e-a5cd-91653dd0506d 55154-1177 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Cardinal Health IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-1178_9a1522ff-e0cc-4f7d-88c5-f052d1dfbc8c 55154-1178 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100225 ANDA ANDA076899 Cardinal Health SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 55154-1183_7977868d-300d-4f0a-9ee0-8ac270ae9fe4 55154-1183 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-1184_6d24a60e-2eb8-4a4b-a687-adf1aeaebdcc 55154-1184 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55154-1186_a3a9858c-be31-41c0-ad55-551f05da4f0f 55154-1186 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Cardinal Health NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-1242_2aa00dee-4801-4671-9885-669c1f6fc122 55154-1242 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070906 ANDA ANDA078500 Cardinal Health AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-1276_91582f00-ac72-4ed2-8de7-5cbc7db1ec56 55154-1276 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19960718 ANDA ANDA064030 Cardinal Health ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55154-1277_a1d69517-7f8f-4b71-b031-4941fb856205 55154-1277 HUMAN PRESCRIPTION DRUG Ephedrine Sulfate Ephedrine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20090401 20160229 UNAPPROVED DRUG OTHER Cardinal Health EPHEDRINE SULFATE 50 mg/mL 55154-1278_a3b79eb8-29f9-4ca8-bccc-1a9919f7871f 55154-1278 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20090501 ANDA ANDA040730 Cardinal Health HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-1279_25b55b66-44d4-471a-8e08-ee498aacdb69 55154-1279 HUMAN PRESCRIPTION DRUG Adenosine adenosine INJECTION, SOLUTION INTRAVENOUS 20110317 ANDA ANDA078076 Cardinal Health ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 55154-1280_e992b777-4ff5-4cc2-ad8d-70971738b585 55154-1280 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20090501 ANDA ANDA040730 Cardinal Health HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-1281_e653b80b-f8fa-4169-a5cb-427b4599a59e 55154-1281 HUMAN PRESCRIPTION DRUG Physostigmine Salicylate Physostigmine Salicylate INJECTION INTRAVENOUS 20100810 UNAPPROVED DRUG OTHER Cardinal Health PHYSOSTIGMINE SALICYLATE 1 mg/mL 55154-1325_f382f8c9-2262-4df4-8944-2bbc75cd963d 55154-1325 HUMAN OTC DRUG Mapap Acetaminophen TABLET ORAL 20110531 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 325 mg/1 55154-1327_123af780-1165-4a00-8cbc-09cc5704fcba 55154-1327 HUMAN OTC DRUG Senna Sennosides TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health SENNOSIDES 8.6 mg/1 55154-1333_44e17773-d5e6-4962-8fa0-fa3bdda04c5d 55154-1333 HUMAN OTC DRUG Senna Plus sennosides TABLET ORAL 20110603 UNAPPROVED DRUG OTHER Cardinal Health DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 55154-1336_bd6632b2-bd80-43b4-a4ba-fa0ac794dfc3 55154-1336 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090610 ANDA ANDA076969 Cardinal Health METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-1337_8ec58698-6b12-4c33-8285-737bf11798de 55154-1337 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20081030 ANDA ANDA040733 Cardinal Health DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 55154-1339_697e6ccd-6640-4d3a-a110-f587bd61d75c 55154-1339 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20040203 ANDA ANDA075483 Cardinal Health ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55154-1340_697e6ccd-6640-4d3a-a110-f587bd61d75c 55154-1340 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20040203 ANDA ANDA075483 Cardinal Health ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55154-1341_428de905-477e-439f-a408-8f9d46999b43 55154-1341 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20070216 ANDA ANDA076001 Cardinal Health FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-1342_926bb322-a23b-4cc6-80ee-868f2c565c4e 55154-1342 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Cardinal Health IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-1344_b3f30758-5bc3-4c7a-96f1-0207889ff1e6 55154-1344 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20081113 ANDA ANDA089808 Cardinal Health THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 55154-1345_b3f30758-5bc3-4c7a-96f1-0207889ff1e6 55154-1345 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20081113 ANDA ANDA089763 Cardinal Health THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 55154-1347_c25caca1-ccb9-4100-b01b-cc432a29375a 55154-1347 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20020813 ANDA ANDA072264 Cardinal Health BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 55154-1348_bd6632b2-bd80-43b4-a4ba-fa0ac794dfc3 55154-1348 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090610 ANDA ANDA076969 Cardinal Health METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-1375_536fce9d-c40a-4363-879d-fbdc40076367 55154-1375 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20091102 ANDA ANDA074823 Cardinal Health TERAZOSIN HYDROCHLORIDE ANHYDROUS 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55154-1376_b7bb532b-33bd-4c06-b2ba-ba2668d718c8 55154-1376 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100111 ANDA ANDA077880 Cardinal Health METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 55154-1379_991f0a15-bb40-4ecf-b565-5436665ba3c6 55154-1379 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Cardinal Health GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-1380_926bb322-a23b-4cc6-80ee-868f2c565c4e 55154-1380 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Cardinal Health IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-1383_d6ff6f94-5cb4-44c3-a9e5-65c1625e6a1f 55154-1383 HUMAN PRESCRIPTION DRUG FAMOTIDINE FAMOTIDINE TABLET, FILM COATED ORAL 20090610 ANDA ANDA075718 Cardinal Health FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55154-1384_fd8f0b6b-5cfe-4795-a7db-18370bb89c41 55154-1384 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20100312 ANDA ANDA077836 Cardinal Health GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 55154-1385_536fce9d-c40a-4363-879d-fbdc40076367 55154-1385 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20091102 ANDA ANDA074823 Cardinal Health TERAZOSIN HYDROCHLORIDE ANHYDROUS 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55154-1386_63d34a9f-c03b-4e3c-821c-8414f4fd1daf 55154-1386 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100510 ANDA ANDA078428 Cardinal Health GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-1387_63d34a9f-c03b-4e3c-821c-8414f4fd1daf 55154-1387 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100510 ANDA ANDA078428 Cardinal Health GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-1389_2834ce85-fbe6-4e37-b925-d7f8713bcd4c 55154-1389 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20100604 ANDA ANDA078251 Cardinal Health CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55154-1390_2cd4dbd4-33be-49be-ab2a-03f71c115d49 55154-1390 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET, FILM COATED ORAL 20100607 ANDA ANDA077584 Cardinal Health PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-1391_2cd4dbd4-33be-49be-ab2a-03f71c115d49 55154-1391 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET, FILM COATED ORAL 20100607 ANDA ANDA077584 Cardinal Health PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-1394_63d34a9f-c03b-4e3c-821c-8414f4fd1daf 55154-1394 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100510 ANDA ANDA078428 Cardinal Health GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-1395_e1beec02-8325-40c4-bfeb-d4ed41c8b7dd 55154-1395 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20100706 ANDA ANDA077987 Cardinal Health PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-1396_02384b45-ad42-43e4-ab26-2cae0c1f8eca 55154-1396 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 20100920 ANDA ANDA077272 Cardinal Health CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 55154-1397_857be233-613e-4a2a-aab5-c53c55eec8e6 55154-1397 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20100723 ANDA ANDA077824 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55154-1398_83510333-f07d-4b81-a3ae-2801d114bd31 55154-1398 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET ORAL 20091102 ANDA ANDA077903 Cardinal Health ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55154-1399_83510333-f07d-4b81-a3ae-2801d114bd31 55154-1399 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET ORAL 20091102 ANDA ANDA077903 Cardinal Health ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55154-1405_fa16dfec-90bd-4524-9ca3-c44695d72bc8 55154-1405 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Cardinal Health RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 55154-1407_fa16dfec-90bd-4524-9ca3-c44695d72bc8 55154-1407 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Cardinal Health RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 55154-1408_fa16dfec-90bd-4524-9ca3-c44695d72bc8 55154-1408 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Cardinal Health RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 55154-1409_fa16dfec-90bd-4524-9ca3-c44695d72bc8 55154-1409 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Cardinal Health RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 55154-1411_8c7cf97c-83ad-4caf-a68d-63fe2145444b 55154-1411 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Cardinal Health RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 55154-1412_8c7cf97c-83ad-4caf-a68d-63fe2145444b 55154-1412 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Cardinal Health RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 55154-1413_8c7cf97c-83ad-4caf-a68d-63fe2145444b 55154-1413 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Cardinal Health RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 55154-1414_8c7cf97c-83ad-4caf-a68d-63fe2145444b 55154-1414 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Cardinal Health RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 55154-1422_67bec627-35ea-4650-ab83-992708736718 55154-1422 HUMAN PRESCRIPTION DRUG Xarelto rivaroxaban TABLET, FILM COATED ORAL 20110701 NDA NDA022406 Cardinal Health RIVAROXABAN 10 mg/1 Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] 55154-1423_67bec627-35ea-4650-ab83-992708736718 55154-1423 HUMAN PRESCRIPTION DRUG Xarelto rivaroxaban TABLET, FILM COATED ORAL 20111105 NDA NDA202439 Cardinal Health RIVAROXABAN 20 mg/1 Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] 55154-1458_5de5e68e-7c8d-4ce2-b347-ab48e311b722 55154-1458 HUMAN OTC DRUG Oyster Shell Calcium with Vitamin D Oyster Shell Calcium with Vitamin D TABLET, FILM COATED ORAL 20051115 UNAPPROVED DRUG OTHER Cardinal Health CALCIUM; CHOLECALCIFEROL 500; 200 mg/1; [iU]/1 55154-1463_dcb85ae7-2812-4a71-84e6-92b007e9c480 55154-1463 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength Aspirin TABLET, DELAYED RELEASE ORAL 20130628 OTC MONOGRAPH FINAL part343 Cardinal Health ASPIRIN 325 mg/3251 55154-1473_af341378-e9ad-4d48-8588-c9c3222d0635 55154-1473 HUMAN OTC DRUG Childrens Chewable Aspirin Aspirin TABLET, CHEWABLE ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health ASPIRIN 81 mg/1 55154-1476_f82a3ca9-e2fd-4797-a881-4b9bc68ab093 55154-1476 HUMAN OTC DRUG Enteric Aspirin Enteric Aspirin TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health ASPIRIN 81 mg/1 55154-1477_066b9348-5585-4d43-aef7-f440d0492fd8 55154-1477 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health DOCUSATE SODIUM 100 mg/1 55154-1478_512e593a-3f26-4955-b1db-a0ed09d3b5cb 55154-1478 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20090810 ANDA ANDA074726 Cardinal Health POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55154-1479_27ffb185-0ea7-4a9d-9e91-d525b27d018c 55154-1479 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20090720 ANDA ANDA075682 Cardinal Health IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-1480_b0fee3aa-7cfe-4d99-9566-cfb4d57dee4a 55154-1480 HUMAN OTC DRUG Simethicone Simethicone TABLET ORAL 20110606 UNAPPROVED DRUG OTHER Cardinal Health DIMETHICONE 80 mg/1 55154-1483_20ef2897-6f34-4234-9a6f-c5cd50bee20a 55154-1483 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070628 ANDA ANDA040412 Cardinal Health HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55154-1484_d44eee8a-fa0b-48b0-9438-0eaf3aa394de 55154-1484 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20050110 ANDA ANDA073589 Cardinal Health CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 55154-1485_1c9b1dc0-fb7f-43d9-8a8f-6e5989bbfc36 55154-1485 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20101108 UNAPPROVED DRUG OTHER Cardinal Health DOCUSATE SODIUM 100 mg/1 55154-1486_46513540-2711-4987-b554-0bb81e2665f1 55154-1486 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070620 ANDA ANDA075350 Cardinal Health GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-1487_426d5014-4e76-4c57-9ed7-1f19434d87f1 55154-1487 HUMAN PRESCRIPTION DRUG Hydralazine Hydralazine TABLET ORAL 20090914 ANDA ANDA088468 Cardinal Health HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-1489_c00da4da-24d0-4d54-928d-9487e4fc51d8 55154-1489 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20070709 ANDA ANDA040489 Cardinal Health METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55154-1490_426d5014-4e76-4c57-9ed7-1f19434d87f1 55154-1490 HUMAN PRESCRIPTION DRUG Hydralazine Hydralazine TABLET ORAL 20090914 ANDA ANDA088468 Cardinal Health HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-1491_46513540-2711-4987-b554-0bb81e2665f1 55154-1491 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070620 ANDA ANDA075350 Cardinal Health GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-1492_100addaa-061c-4cdf-85fd-8621682e0aa2 55154-1492 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20061115 ANDA ANDA071135 Cardinal Health DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 55154-1493_e9791af2-bb5c-4b36-91e2-ab7b22914845 55154-1493 HUMAN OTC DRUG aspirin aspirin TABLET, COATED ORAL 20121113 OTC MONOGRAPH FINAL part343 Cardinal Health ASPIRIN 81 mg/1 55154-1494_50d77f8b-f1f8-441a-bd05-807ed9194fb9 55154-1494 HUMAN OTC DRUG aspirin aspirin TABLET, COATED ORAL 20121113 OTC MONOGRAPH FINAL part343 Cardinal Health ASPIRIN 81 mg/1 55154-1495_7ef588d4-c8b7-4bdd-9dcb-02bb52e30629 55154-1495 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20110601 ANDA ANDA091426 Cardinal Health SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 55154-1496_eda5df13-3ff3-4ddd-929b-9bf0abe6d536 55154-1496 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20050110 ANDA ANDA089805 Cardinal Health ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 55154-1497_c1513777-d357-4b8f-8f11-78093060330b 55154-1497 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20111101 ANDA ANDA040655 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-1498_3fc428dc-47a0-4997-8b32-e68bfd4f6ca1 55154-1498 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110822 ANDA ANDA078010 Cardinal Health FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-1499_c00da4da-24d0-4d54-928d-9487e4fc51d8 55154-1499 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20070703 ANDA ANDA040489 Cardinal Health METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55154-1577_5f8c07e9-f975-4be1-874a-b88c048b5e71 55154-1577 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20040413 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL 55154-1578_4c71071e-6c9f-4059-ba3f-b9c3aa643452 55154-1578 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20051215 ANDA ANDA062512 Cardinal Health NYSTATIN 500000 [USP'U]/5mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 55154-1579_4545d630-a545-4e2f-99ff-6169400230dc 55154-1579 HUMAN PRESCRIPTION DRUG Megestrol Acetate megestrol acetate SUSPENSION ORAL 20040225 ANDA ANDA075671 Cardinal Health MEGESTROL ACETATE 400 mg/10mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 55154-1582_4545d630-a545-4e2f-99ff-6169400230dc 55154-1582 HUMAN PRESCRIPTION DRUG Megestrol Acetate megestrol acetate SUSPENSION ORAL 20040225 ANDA ANDA075671 Cardinal Health MEGESTROL ACETATE 400 mg/10mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 55154-1583_6b9d50d3-0d4e-498d-9b6f-a06d2d20e9a3 55154-1583 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20051025 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 160 mg/5mL 55154-1584_4c18233e-d667-4d6b-9e38-8d37518e4b0e 55154-1584 HUMAN PRESCRIPTION DRUG Diazepam Diazepam SOLUTION ORAL 20120222 ANDA ANDA070928 Cardinal Health DIAZEPAM 5 mg/5mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-1585_822bef41-071e-4bb5-978c-0a0c1224a325 55154-1585 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060914 ANDA ANDA074937 Cardinal Health IBUPROFEN 200 mg/10mL 55154-1586_6af54644-2cb6-48fe-9bcb-a38f67edb040 55154-1586 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20140411 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL 55154-1603_eeddb567-4fce-451e-abe1-1f74fb5aebf7 55154-1603 HUMAN PRESCRIPTION DRUG VICODIN hydrocodone bitartrate and acetaminophen TABLET ORAL 19830107 ANDA ANDA088058 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-1604_2941e685-d8fd-40bc-8d1a-393facbd3826 55154-1604 HUMAN PRESCRIPTION DRUG Vicodin ES hydrocodone bitartrate and acetaminophen TABLET ORAL 20100518 ANDA ANDA089736 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-1607_496ed99b-7bce-4ade-b7c3-6c59feebce6f 55154-1607 HUMAN PRESCRIPTION DRUG VICODIN HP hydrocodone bitartrate and acetaminophen TABLET ORAL 19960923 ANDA ANDA040117 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 660; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 55154-1609_a44897aa-f325-4f8d-bdef-4e4591a14934 55154-1609 HUMAN PRESCRIPTION DRUG Vicoprofen hydrocodone bitartrate and ibuprofen TABLET, COATED ORAL 19970923 NDA NDA020716 Cardinal Health HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 55154-1610_4daba60f-af60-4c7e-916e-f2ad7e7532c5 55154-1610 HUMAN PRESCRIPTION DRUG Dilaudid hydromorphone hydrochloride TABLET ORAL 19260101 NDA NDA019892 Cardinal Health HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55154-1675_45b983e3-b24d-4000-85e4-0441be9683be 55154-1675 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 Cardinal Health METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 55154-1676_45b983e3-b24d-4000-85e4-0441be9683be 55154-1676 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 Cardinal Health METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 55154-1678_f6a3cd62-f127-4f94-8ef6-259a0f2f6605 55154-1678 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20111101 ANDA ANDA200292 Cardinal Health DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55154-1679_7d8cd295-9c74-4c58-ba11-dad094a92113 55154-1679 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 ANDA ANDA078384 Cardinal Health CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55154-1680_7d8cd295-9c74-4c58-ba11-dad094a92113 55154-1680 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 ANDA ANDA078384 Cardinal Health CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55154-1681_7d8cd295-9c74-4c58-ba11-dad094a92113 55154-1681 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 ANDA ANDA078384 Cardinal Health CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55154-1682_7d8cd295-9c74-4c58-ba11-dad094a92113 55154-1682 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 ANDA ANDA078384 Cardinal Health CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55154-1813_47356ea7-b254-404b-ba01-6d1f0ed6145b 55154-1813 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 Cardinal Health OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 55154-1814_47356ea7-b254-404b-ba01-6d1f0ed6145b 55154-1814 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 Cardinal Health OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 55154-1815_47356ea7-b254-404b-ba01-6d1f0ed6145b 55154-1815 HUMAN PRESCRIPTION DRUG ZYPREXA Zydis Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20000601 NDA NDA021086 Cardinal Health OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 55154-1817_47356ea7-b254-404b-ba01-6d1f0ed6145b 55154-1817 HUMAN PRESCRIPTION DRUG ZYPREXA Zydis Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20000601 NDA NDA021086 Cardinal Health OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 55154-1818_9070fc7c-7584-421f-8c8c-0d239d6f9fb3 55154-1818 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Cardinal Health DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-1824_9070fc7c-7584-421f-8c8c-0d239d6f9fb3 55154-1824 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Cardinal Health DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-1825_514622f9-891b-4b32-87db-e494afd19ac4 55154-1825 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 Cardinal Health ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 55154-1827_9070fc7c-7584-421f-8c8c-0d239d6f9fb3 55154-1827 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Cardinal Health DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-1828_47356ea7-b254-404b-ba01-6d1f0ed6145b 55154-1828 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19970623 NDA NDA020592 Cardinal Health OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 55154-1830_36627750-76d6-4ac3-9f3c-4cf2c33a694b 55154-1830 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Cardinal Health TADALAFIL 5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 55154-1831_78d7f193-583d-4dca-9d3c-6af81fbae2f4 55154-1831 HUMAN PRESCRIPTION DRUG Effient Prasugrel hydrochloride TABLET, FILM COATED ORAL 20120301 NDA NDA022307 Cardinal Health PRASUGREL HYDROCHLORIDE 10 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 55154-1855_a8b08d72-9446-42c7-8b7b-d46561d3b4ae 55154-1855 HUMAN PRESCRIPTION DRUG URSO ursodiol TABLET, FILM COATED ORAL 19971210 NDA NDA020675 Cardinal Health URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 55154-1875_5e6f748c-1786-46a1-8e5f-46bc3bb0fdbc 55154-1875 HUMAN OTC DRUG Docusate Calcium docusate calcium CAPSULE, LIQUID FILLED ORAL 20110601 UNAPPROVED DRUG OTHER Cardinal Health DOCUSATE CALCIUM 240 mg/1 55154-1876_498ae66d-2f66-40d3-bc3c-ee7af8d57a59 55154-1876 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Cardinal Health DOCUSATE SODIUM 100 mg/1 55154-1877_2003456b-3cf7-4c36-9dbf-ebf6d8f21816 55154-1877 HUMAN OTC DRUG Senna Plus Sennosides and Docusate Sodium TABLET ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Cardinal Health DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 55154-1908_d4ed06cd-20a1-4b6d-ba8a-0a2a71e9a0ff 55154-1908 HUMAN PRESCRIPTION DRUG TYLENOL with Codeine acetaminophen and codeine phosphate TABLET ORAL 19820101 ANDA ANDA085055 Cardinal Health ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII 55154-1909_937d3bee-2c37-4dac-a79b-2c2b2075db7d 55154-1909 HUMAN OTC DRUG TYLENOL Extra Strength Acetaminophen TABLET, COATED ORAL 20130306 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 500 mg/1 55154-1916_d4ed06cd-20a1-4b6d-ba8a-0a2a71e9a0ff 55154-1916 HUMAN PRESCRIPTION DRUG TYLENOL with Codeine acetaminophen and codeine phosphate TABLET ORAL 19820101 ANDA ANDA085055 Cardinal Health ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 CIII 55154-1918_dcd513e5-78f3-4e80-86bd-3ff26cfc7371 55154-1918 HUMAN OTC DRUG Tylenol Acetaminophen TABLET ORAL 20110606 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 325 mg/1 55154-1925_0a997a7b-4735-44c9-9b8c-1aa493c70d43 55154-1925 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 Cardinal Health LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55154-1926_0a997a7b-4735-44c9-9b8c-1aa493c70d43 55154-1926 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 Cardinal Health LEVOFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55154-1927_0a997a7b-4735-44c9-9b8c-1aa493c70d43 55154-1927 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 Cardinal Health LEVOFLOXACIN 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55154-1950_6bac7be7-132b-4b3e-bbac-0badc28ed42d 55154-1950 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20110620 OTC MONOGRAPH FINAL part333B Cardinal Health BACITRACIN 500 [USP'U]/g 55154-1951_8ce50351-1db0-43de-9885-b33fd391305e 55154-1951 HUMAN OTC DRUG Bisacodyl Bisacodyl SUPPOSITORY RECTAL 20110602 OTC MONOGRAPH NOT FINAL part334 Cardinal Health BISACODYL 10 mg/1 55154-1953_8202624a-4ab7-4ec5-84a8-d38ed7e6292a 55154-1953 HUMAN OTC DRUG Triple Antibiotic Polymyxin B, Bacitracin, Neomycin OINTMENT TOPICAL 20110606 UNAPPROVED DRUG OTHER Cardinal Health BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B 400; 3.5; 5000 [USP'U]/1; mg/1; [USP'U]/1 55154-1954_62254b94-8fd4-404a-98ab-7dd9df57e0d5 55154-1954 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 Cardinal Health LORATADINE 10 mg/1 55154-2016_cb1ce9ec-4f07-4cc9-85bb-663ee1f2ccc7 55154-2016 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 20070920 NDA NDA020839 Cardinal Health CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 55154-2021_d68bb6af-5fee-4f77-99fd-b9f63e04f509 55154-2021 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Cardinal Health ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] 55154-2022_cb1ce9ec-4f07-4cc9-85bb-663ee1f2ccc7 55154-2022 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 19971117 NDA NDA020839 Cardinal Health CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 55154-2023_716ab835-584e-4bdc-ac7c-f685d88b4dad 55154-2023 HUMAN PRESCRIPTION DRUG AVALIDE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET ORAL 19970930 NDA NDA020758 Cardinal Health HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55154-2024_716ab835-584e-4bdc-ac7c-f685d88b4dad 55154-2024 HUMAN PRESCRIPTION DRUG AVALIDE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET ORAL 19980831 NDA NDA020758 Cardinal Health HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55154-2025_d68bb6af-5fee-4f77-99fd-b9f63e04f509 55154-2025 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Cardinal Health ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] 55154-2026_4cd668d2-8bba-43d2-a0e6-d1e9d2c0d04a 55154-2026 HUMAN PRESCRIPTION DRUG AVAPRO IRBESARTAN TABLET ORAL 19970930 NDA NDA020757 Cardinal Health IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-2027_4728ab46-ad9b-4fd9-a8bd-9f51ffa84127 55154-2027 HUMAN PRESCRIPTION DRUG AVALIDE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20110225 NDA NDA020758 Cardinal Health HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55154-2028_4728ab46-ad9b-4fd9-a8bd-9f51ffa84127 55154-2028 HUMAN PRESCRIPTION DRUG AVALIDE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20110224 NDA NDA020758 Cardinal Health HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55154-2029_d68bb6af-5fee-4f77-99fd-b9f63e04f509 55154-2029 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Cardinal Health ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] 55154-2030_d68bb6af-5fee-4f77-99fd-b9f63e04f509 55154-2030 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Cardinal Health ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] 55154-2031_d68bb6af-5fee-4f77-99fd-b9f63e04f509 55154-2031 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Cardinal Health ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] 55154-2032_d68bb6af-5fee-4f77-99fd-b9f63e04f509 55154-2032 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Cardinal Health ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] 55154-2051_fb3d8b1e-45d2-4ae4-ab22-6c31f9014d1d 55154-2051 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100115 ANDA ANDA074984 Cardinal Health DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-2052_fb3d8b1e-45d2-4ae4-ab22-6c31f9014d1d 55154-2052 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100115 ANDA ANDA074984 Cardinal Health DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-2056_3867e879-19d4-4e61-8d19-7677ad3188b2 55154-2056 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090311 ANDA ANDA018832 Cardinal Health ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 55154-2058_996d6146-22ea-4cdd-a0d1-68611015f20e 55154-2058 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20091118 ANDA ANDA077064 Cardinal Health METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 55154-2062_c5316f09-0c95-4b02-a3be-4d181686fe34 55154-2062 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080402 ANDA ANDA065404 Cardinal Health AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55154-2063_607b6c59-8727-45ab-9872-8439695c60da 55154-2063 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070904 ANDA ANDA040597 Cardinal Health BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 55154-2064_f6647634-7cb2-4d9a-b991-30b4abdbf821 55154-2064 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091221 ANDA ANDA040625 Cardinal Health FOLIC ACID 1 mg/1 55154-2065_7efc7f41-3eba-4c69-8d60-25a2e9b387d7 55154-2065 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090922 ANDA ANDA077633 Cardinal Health LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-2068_7dbc4275-2472-4eba-a8b1-6e4fe5cab5bf 55154-2068 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041210 ANDA ANDA075350 Cardinal Health GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-2069_ef094cc5-d9cd-4d6c-ac22-f8ee6ae28528 55154-2069 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET ORAL 20091014 ANDA ANDA078426 Cardinal Health ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55154-2070_ef094cc5-d9cd-4d6c-ac22-f8ee6ae28528 55154-2070 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET ORAL 20091014 ANDA ANDA078426 Cardinal Health ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55154-2071_a934d7e8-bc5f-4c0a-896f-e558dbb7ae8e 55154-2071 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20071203 ANDA ANDA074112 Cardinal Health ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-2072_a1350db7-5f5f-4529-a9f8-d0beb343bc23 55154-2072 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20100115 ANDA ANDA040245 Cardinal Health CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 55154-2073_5c7ce0fe-dbef-431d-95aa-babdd526b8d9 55154-2073 HUMAN PRESCRIPTION DRUG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET ORAL 20090924 ANDA ANDA040511 Cardinal Health ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 55154-2074_a5dd56db-1b90-4cbd-92e1-b6b59f2b071d 55154-2074 HUMAN PRESCRIPTION DRUG Hydroxychloroquine sulfate Hydroxychloroquine sulfate TABLET, FILM COATED ORAL 20080805 ANDA ANDA040657 Cardinal Health HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 55154-2075_bed1e444-f0a7-49fc-952f-fa4c2469cfc9 55154-2075 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20091013 ANDA ANDA071135 Cardinal Health DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-2076_7d0d1968-8bf4-4f07-a89f-2ca355740900 55154-2076 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20090706 ANDA ANDA040248 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-2077_d7bd10f4-c7b8-4a4d-a183-18e0fdda9498 55154-2077 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20070802 ANDA ANDA077662 Cardinal Health GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-2078_7dbc4275-2472-4eba-a8b1-6e4fe5cab5bf 55154-2078 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041210 ANDA ANDA075350 Cardinal Health GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-2080_fa8963fb-f9f8-467c-ae8c-9cd5d24585fc 55154-2080 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110323 ANDA ANDA075682 Cardinal Health IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-2081_ef3957a2-c83a-4ec5-a07c-e922bfbcf14a 55154-2081 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040819 ANDA ANDA076794 Cardinal Health CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55154-2082_b0c0b7cc-459b-44ba-aee1-473fe12991a1 55154-2082 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20080318 ANDA ANDA086242 Cardinal Health HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-2083_b0c0b7cc-459b-44ba-aee1-473fe12991a1 55154-2083 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20080318 ANDA ANDA086242 Cardinal Health HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-2084_a55aea68-42d5-44fc-8916-22b978af5a59 55154-2084 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20110207 ANDA ANDA077058 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55154-2085_780f5a28-9b5c-4b5f-958e-d1a07f1ba2ec 55154-2085 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20100114 ANDA ANDA075180 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55154-2086_ef3957a2-c83a-4ec5-a07c-e922bfbcf14a 55154-2086 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040819 ANDA ANDA076794 Cardinal Health CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55154-2087_f62d0fc5-f39b-40d7-a79f-29fca72966fe 55154-2087 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100907 ANDA ANDA076813 Cardinal Health ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 55154-2088_f62d0fc5-f39b-40d7-a79f-29fca72966fe 55154-2088 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100907 ANDA ANDA076813 Cardinal Health ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 55154-2089_8b08401f-fc1b-4e9e-9962-598a8e0f37be 55154-2089 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101014 ANDA ANDA078243 Cardinal Health LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-2090_f78baa0f-8b79-494a-9de8-a4aad717e547 55154-2090 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20100121 ANDA ANDA076368 Cardinal Health POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55154-2091_ff042130-c43a-4281-a731-809a54a1a7f1 55154-2091 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20110601 ANDA ANDA078500 Cardinal Health AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-2092_a934d7e8-bc5f-4c0a-896f-e558dbb7ae8e 55154-2092 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20071203 ANDA ANDA074112 Cardinal Health ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-2093_9daf927d-27d1-4ac1-b0c4-6f8b4f11becc 55154-2093 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20080509 UNAPPROVED DRUG OTHER Cardinal Health PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 55154-2094_e5057538-4447-45fe-9623-efe3594e2d50 55154-2094 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20100114 ANDA ANDA040742 Cardinal Health BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 55154-2095_266bac10-f40d-4982-a0dc-3e268bdb6fb2 55154-2095 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20090113 ANDA ANDA040787 Cardinal Health HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 55154-2096_972659d8-e733-472c-9ca5-c45e2beb6d94 55154-2096 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120116 NDA AUTHORIZED GENERIC NDA020702 Cardinal Health ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-2097_fb3d8b1e-45d2-4ae4-ab22-6c31f9014d1d 55154-2097 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100115 ANDA ANDA074984 Cardinal Health DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-2098_c185561b-8a18-412e-9bfb-50d2c6f11de4 55154-2098 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100813 ANDA ANDA090615 Cardinal Health METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-2099_c185561b-8a18-412e-9bfb-50d2c6f11de4 55154-2099 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100813 ANDA ANDA090615 Cardinal Health METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-2175_4aee9eb9-0407-42c5-a801-6b91617b792a 55154-2175 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Cardinal Health ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 55154-2176_4aee9eb9-0407-42c5-a801-6b91617b792a 55154-2176 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Cardinal Health ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 55154-2208_fb1c4767-dd02-4abc-9cb7-f85bb12a4867 55154-2208 HUMAN PRESCRIPTION DRUG Cardizem CD Diltiazem Hydrochloride CAPSULE ORAL 20010411 NDA NDA020062 Cardinal Health DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-2225_c8a45a8f-7f97-4945-99e2-5142a85bc31c 55154-2225 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076578 Cardinal Health ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55154-2226_c8a45a8f-7f97-4945-99e2-5142a85bc31c 55154-2226 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076578 Cardinal Health ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55154-2230_714bd852-e9b1-4bda-8685-02f16c937222 55154-2230 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20000511 ANDA ANDA075491 Cardinal Health BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 55154-2231_83f9ef69-8b54-419d-988e-cf8dbefa8d71 55154-2231 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA076008 Cardinal Health BUSPIRONE HYDROCHLORIDE 15 mg/1 55154-2275_799d3b00-809b-4abc-989c-05faccec49f8 55154-2275 HUMAN PRESCRIPTION DRUG Angiomax bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20001215 NDA NDA020873 Cardinal Health BIVALIRUDIN 250 mg/1 Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] 55154-2305_4139268c-143d-4952-8453-630d042d4638 55154-2305 HUMAN PRESCRIPTION DRUG Asacol mesalamine TABLET, DELAYED RELEASE ORAL 19920401 NDA NDA019651 Cardinal Health MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 55154-2308_280ff423-3a13-4fd9-9fdd-3e3427d3a14b 55154-2308 HUMAN OTC DRUG Metamucil Therapy for Regularity Psyllium Husk POWDER ORAL 19890331 UNAPPROVED DRUG OTHER Cardinal Health PSYLLIUM HUSK 3.4 g/12g 55154-2350_9ab50557-72a0-47ee-90c6-ef2b0c19923e 55154-2350 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100729 ANDA ANDA062933 Cardinal Health VANCOMYCIN HYDROCHLORIDE 1 g/250mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 55154-2351_9ab50557-72a0-47ee-90c6-ef2b0c19923e 55154-2351 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100729 ANDA ANDA062931 Cardinal Health VANCOMYCIN HYDROCHLORIDE 500 mg/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 55154-2353_c40b0d8c-23f7-4882-b6f4-62fcadb622e0 55154-2353 HUMAN PRESCRIPTION DRUG Metoclopramide METOCLOPRAMIDE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090922 ANDA ANDA073118 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 55154-2354_49f17cc0-a8db-49db-97af-87b42b1e9751 55154-2354 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION RETROBULBAR; TOPICAL 20100324 ANDA ANDA088295 Cardinal Health LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-2355_4e837ee8-53e7-448e-8a00-d2f2aae0b8a2 55154-2355 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 19980706 ANDA ANDA075160 Cardinal Health METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-2356_e5363af0-4edc-43cc-8568-c314d8a7b276 55154-2356 HUMAN PRESCRIPTION DRUG Vitamin K1 PHYTONADIONE INJECTION, EMULSION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110824 ANDA ANDA087955 Cardinal Health PHYTONADIONE 10 mg/mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 55154-2359_eb0bf16b-8747-4070-baaa-d32085cb029f 55154-2359 HUMAN PRESCRIPTION DRUG Depakote Divalproex sodium TABLET, EXTENDED RELEASE ORAL 20100607 NDA NDA021168 Cardinal Health DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-2364_dda65853-8e26-4da2-83a3-3a7e740b3bba 55154-2364 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100713 NDA AUTHORIZED GENERIC NDA018667 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-2365_8f786078-7611-4784-a72a-46f3d6a2841a 55154-2365 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100713 NDA AUTHORIZED GENERIC NDA018667 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-2366_53eaa46e-6b65-4e39-8535-0a072bb38e4d 55154-2366 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline Dihydrate INJECTION, SOLUTION INTRAVENOUS 20110211 ANDA ANDA087242 Cardinal Health AMINOPHYLLINE DIHYDRATE 25 mg/mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 55154-2367_c7bd63ec-452c-4ddc-9327-21aad5216fe4 55154-2367 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE INJECTION INTRAVENOUS 19720316 ANDA ANDA080205 Cardinal Health POTASSIUM CHLORIDE 149 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55154-2368_67d9feff-0cae-4c4c-bc45-f0b7aee7705c 55154-2368 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20090908 NDA NDA016964 Cardinal Health BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 55154-2371_ab1436e1-40af-493a-b548-8773a0ffe40c 55154-2371 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA088299 Cardinal Health LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-2372_afd7c91b-3283-49e7-b79f-1c8d0c1a53bd 55154-2372 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION EPIDURAL; INFILTRATION 20100330 ANDA ANDA088329 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-2373_ab1436e1-40af-493a-b548-8773a0ffe40c 55154-2373 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA088327 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-2375_edeb0556-0643-4693-9779-7d5dda8b4062 55154-2375 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine lidocaine hydrochloride anhydrous and epinephrine INJECTION, SOLUTION INFILTRATION 20100405 ANDA ANDA089644 Cardinal Health EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 10; 10 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-2376_76df87ae-c15c-4a03-8a1c-6cfa3ae871c9 55154-2376 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine lidocaine hydrochloride anhydrous and epinephrine INJECTION, SOLUTION INFILTRATION 20100405 ANDA ANDA089644 Cardinal Health EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 10; 10 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-2379_f8b8e684-1408-444a-9858-17e411a08337 55154-2379 HUMAN PRESCRIPTION DRUG Sterile Water WATER INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110915 NDA NDA018801 Cardinal Health WATER 50 mL/50mL 55154-2380_0666ae92-0a62-41e2-a3e0-67b83e2889b5 55154-2380 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20091207 ANDA ANDA089522 Cardinal Health HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 55154-2381_6144b518-741e-4ad4-a3fd-c2b7faa9c8c9 55154-2381 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION ENDOTRACHEAL; INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20130508 UNAPPROVED DRUG OTHER Cardinal Health EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-2383_00284029-6e70-430e-adea-c5bde6a9860e 55154-2383 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 20110727 ANDA ANDA074802 Cardinal Health KETOROLAC TROMETHAMINE 60 mg/2mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-2385_e78bfa6d-d257-46a0-84a7-8d722c58830d 55154-2385 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100729 ANDA ANDA062933 Cardinal Health VANCOMYCIN HYDROCHLORIDE 1 g/250mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 55154-2388_e5363af0-4edc-43cc-8568-c314d8a7b276 55154-2388 HUMAN PRESCRIPTION DRUG Vitamin K1 PHYTONADIONE INJECTION, EMULSION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110824 ANDA ANDA087954 Cardinal Health PHYTONADIONE 2 mg/mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 55154-2390_9ac0f81d-27f2-4db5-ad07-346f40133084 55154-2390 HUMAN PRESCRIPTION DRUG Clindamycin CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20110609 ANDA ANDA062801 Cardinal Health CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 55154-2391_2633c775-8a3e-44d4-8909-0f34dc59d405 55154-2391 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100713 NDA AUTHORIZED GENERIC NDA018667 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-2391_342a0b3b-3638-4c43-9ff6-1f8cfd6c5b6c 55154-2391 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100713 NDA AUTHORIZED GENERIC NDA018667 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-2392_011884fd-212b-441e-8499-045a31edcebf 55154-2392 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate INJECTION, SOLUTION, CONCENTRATE INTRAMUSCULAR; INTRAVENOUS 19830815 ANDA ANDA062420 Cardinal Health GENTAMICIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 55154-2393_fc83794b-9bca-4ab4-817b-400640973a14 55154-2393 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100604 ANDA ANDA062912 Cardinal Health VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 55154-2395_52688e2d-d8a9-493d-ac58-07c2c347afb0 55154-2395 HUMAN PRESCRIPTION DRUG GENGRAF cyclosporine CAPSULE ORAL 20100524 ANDA ANDA065003 Cardinal Health CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 55154-2396_52688e2d-d8a9-493d-ac58-07c2c347afb0 55154-2396 HUMAN PRESCRIPTION DRUG GENGRAF cyclosporine CAPSULE ORAL 20100524 ANDA ANDA065003 Cardinal Health CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 55154-2398_fc83794b-9bca-4ab4-817b-400640973a14 55154-2398 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100604 ANDA ANDA062911 Cardinal Health VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 55154-2399_65564722-b245-40ee-9aed-d6989d0542e4 55154-2399 HUMAN PRESCRIPTION DRUG Nalbuphine Hydrochloride Nalbuphine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19890203 ANDA ANDA070914 Cardinal Health NALBUPHINE HYDROCHLORIDE 10 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] 55154-2415_391e3f26-00fc-4ef0-aa5c-24264781a6a9 55154-2415 HUMAN PRESCRIPTION DRUG Neurontin gabapentin CAPSULE ORAL 19931230 NDA NDA020235 Cardinal Health GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-2416_95d29970-f8ef-4799-b489-ebe2285de4de 55154-2416 HUMAN PRESCRIPTION DRUG Dilantin Infatabs Phenytoin TABLET, CHEWABLE ORAL 19790226 ANDA ANDA084427 Cardinal Health PHENYTOIN 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-2418_b342078c-2f2f-4f66-82bd-1ac0c095fbc1 55154-2418 HUMAN PRESCRIPTION DRUG Accupril quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA NDA019885 Cardinal Health QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-2421_d04f4b8d-44d2-4b84-a847-26623a05b84c 55154-2421 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Cardinal Health ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-2422_d04f4b8d-44d2-4b84-a847-26623a05b84c 55154-2422 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Cardinal Health ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-2423_b342078c-2f2f-4f66-82bd-1ac0c095fbc1 55154-2423 HUMAN PRESCRIPTION DRUG Accupril quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA NDA019885 Cardinal Health QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-2427_1351c610-a7fb-402a-82d9-a19796dbcc10 55154-2427 HUMAN PRESCRIPTION DRUG Lyrica pregabalin CAPSULE ORAL 20041230 NDA NDA021724 Cardinal Health PREGABALIN 25 mg/1 CV 55154-2428_d04f4b8d-44d2-4b84-a847-26623a05b84c 55154-2428 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Cardinal Health ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-2429_da603245-1782-487d-b6be-d91162f80bc9 55154-2429 HUMAN PRESCRIPTION DRUG Dilantin Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 19760827 ANDA ANDA084349 Cardinal Health PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-2430_1351c610-a7fb-402a-82d9-a19796dbcc10 55154-2430 HUMAN PRESCRIPTION DRUG Lyrica pregabalin CAPSULE ORAL 20041230 NDA NDA021724 Cardinal Health PREGABALIN 50 mg/1 CV 55154-2431_1351c610-a7fb-402a-82d9-a19796dbcc10 55154-2431 HUMAN PRESCRIPTION DRUG Lyrica pregabalin CAPSULE ORAL 20041230 NDA NDA021724 Cardinal Health PREGABALIN 75 mg/1 CV 55154-2432_1351c610-a7fb-402a-82d9-a19796dbcc10 55154-2432 HUMAN PRESCRIPTION DRUG Lyrica pregabalin CAPSULE ORAL 20041230 NDA NDA021724 Cardinal Health PREGABALIN 100 mg/1 CV 55154-2433_62816aac-6454-4b0b-8ec6-4209d07e7b59 55154-2433 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 Cardinal Health NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 55154-2434_d04f4b8d-44d2-4b84-a847-26623a05b84c 55154-2434 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20000407 NDA NDA020702 Cardinal Health ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-2450_51a9efc4-196f-43a3-9cec-279906de3bfa 55154-2450 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 19961126 NDA NDA020690 Cardinal Health DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55154-2451_83cfa7e2-3375-469d-bf5c-e77129300329 55154-2451 HUMAN PRESCRIPTION DRUG AcipHex rabeprazole sodium TABLET, COATED ORAL 19990819 NDA NDA020973 Cardinal Health RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55154-2452_51a9efc4-196f-43a3-9cec-279906de3bfa 55154-2452 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 19961126 NDA NDA020690 Cardinal Health DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55154-2475_71dc3f3d-7ecf-40d6-9050-29f07ed268be 55154-2475 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SUSPENSION INTRAMUSCULAR; INTRAVENOUS 20070629 ANDA ANDA065316 Cardinal Health AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 55154-2476_71dc3f3d-7ecf-40d6-9050-29f07ed268be 55154-2476 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SUSPENSION INTRAMUSCULAR; INTRAVENOUS 20110520 UNAPPROVED DRUG OTHER Cardinal Health AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 55154-2535_9d6de858-bf76-47a4-9d8c-f1bb1ba0d5b5 55154-2535 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Cardinal Health PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-2537_678cc410-9552-443b-b85b-a156dda4c10a 55154-2537 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 Cardinal Health TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 55154-2625_2ce8c8f1-f0b7-45df-a531-42dbd9f2e56c 55154-2625 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal System Nitroglycerin PATCH TRANSDERMAL 19981030 ANDA ANDA089884 Cardinal Health NITROGLYCERIN .2 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 55154-2650_78f1e08f-0a80-4ab0-a39a-640ecf775620 55154-2650 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19820101 ANDA ANDA062031 Cardinal Health DOXYCYCLINE HYCLATE 100 mg/1 55154-2653_78f1e08f-0a80-4ab0-a39a-640ecf775620 55154-2653 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 19830202 ANDA ANDA062421 Cardinal Health DOXYCYCLINE HYCLATE 100 mg/1 55154-2655_75da4891-1b3c-4f1d-b3c7-76f477aa1106 55154-2655 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063181 Cardinal Health MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 55154-2660_221bf87c-652b-4ffc-b9dc-5d1db918c2eb 55154-2660 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 19871101 ANDA ANDA084363 Cardinal Health TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 55154-2661_fe1f0cba-9077-48c3-a867-8732616e4d01 55154-2661 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 19951017 ANDA ANDA074145 Cardinal Health GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55154-2664_2803334f-1525-4aaa-a33a-b244075c4dc8 55154-2664 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Cardinal Health BUSPIRONE HYDROCHLORIDE 10 mg/1 55154-2675_48865fd6-8837-447d-90ab-62e87e46d132 55154-2675 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20110615 ANDA ANDA091195 Cardinal Health TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 55154-2676_48865fd6-8837-447d-90ab-62e87e46d132 55154-2676 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20110615 ANDA ANDA091195 Cardinal Health TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 55154-2677_3e151d1e-706a-44b9-acbd-bd1389b8ec15 55154-2677 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Cardinal Health GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55154-2678_3e151d1e-706a-44b9-acbd-bd1389b8ec15 55154-2678 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Cardinal Health GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55154-2680_66b81167-c015-48ca-8db3-02532830f31a 55154-2680 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Cardinal Health SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-2706_f4eeb69a-be32-4802-979f-6521d00861b4 55154-2706 HUMAN PRESCRIPTION DRUG Procardia XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19890906 NDA NDA019684 Cardinal Health NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-2708_fabdb720-f78c-422a-aa8e-c43645ccdaca 55154-2708 HUMAN PRESCRIPTION DRUG Norvasc amlodipine besylate TABLET ORAL 19920731 NDA NDA019787 Cardinal Health AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-2709_162ba178-a30a-49f2-b7a3-4147f4e4dab8 55154-2709 HUMAN PRESCRIPTION DRUG Zoloft sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Cardinal Health SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-2710_fabdb720-f78c-422a-aa8e-c43645ccdaca 55154-2710 HUMAN PRESCRIPTION DRUG Norvasc amlodipine besylate TABLET ORAL 19920731 NDA NDA019787 Cardinal Health AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-2713_92235375-ee38-49cb-9906-b547fd0d7392 55154-2713 HUMAN PRESCRIPTION DRUG Zithromax azithromycin TABLET, FILM COATED ORAL 19960718 NDA NDA050711 Cardinal Health AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55154-2720_445f10b8-6b8c-4904-a18f-05429df6ce3a 55154-2720 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Cardinal Health ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 55154-2721_445f10b8-6b8c-4904-a18f-05429df6ce3a 55154-2721 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Cardinal Health ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 55154-2722_445f10b8-6b8c-4904-a18f-05429df6ce3a 55154-2722 HUMAN PRESCRIPTION DRUG Geodon ziprasidone mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20031223 NDA NDA020919 Cardinal Health ZIPRASIDONE MESYLATE 20 mg/mL Atypical Antipsychotic [EPC] 55154-2725_d8221a13-334f-47d6-9333-0add270f6288 55154-2725 HUMAN PRESCRIPTION DRUG VFEND voriconazole TABLET, FILM COATED ORAL 20020524 NDA NDA021266 Cardinal Health VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55154-2726_445f10b8-6b8c-4904-a18f-05429df6ce3a 55154-2726 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Cardinal Health ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 55154-2727_a6f4c1b9-39a1-4a06-a882-540bcd990522 55154-2727 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Cardinal Health SILDENAFIL CITRATE 25 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 55154-2728_ba45c5bd-7cff-4c8e-a81d-3a68e8843938 55154-2728 HUMAN PRESCRIPTION DRUG Chantix varenicline tartrate TABLET, FILM COATED ORAL 20060510 NDA NDA021928 Cardinal Health VARENICLINE TARTRATE .5 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] 55154-2729_77af9ffd-f15f-4cf5-acad-446765d1f7f4 55154-2729 HUMAN PRESCRIPTION DRUG Revatio sildenafil citrate TABLET, FILM COATED ORAL 20050603 NDA NDA021845 Cardinal Health SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 55154-2730_d8221a13-334f-47d6-9333-0add270f6288 55154-2730 HUMAN PRESCRIPTION DRUG VFEND voriconazole TABLET, FILM COATED ORAL 20020524 NDA NDA021266 Cardinal Health VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55154-2731_445f10b8-6b8c-4904-a18f-05429df6ce3a 55154-2731 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Cardinal Health ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 55154-2732_2217dd41-a75e-42b4-aafb-f9d7d2e44f42 55154-2732 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Cardinal Health DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-2733_2217dd41-a75e-42b4-aafb-f9d7d2e44f42 55154-2733 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Cardinal Health DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-2734_5256084d-8908-43cf-bf3d-c4db7da1ba4a 55154-2734 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20110721 NDA NDA201370 Cardinal Health HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 55154-2735_89dc5e08-67c7-448a-95e7-56bb77e62cce 55154-2735 HUMAN PRESCRIPTION DRUG HALOPERIDOL HALOPERIDOL LACTATE INJECTION, SOLUTION INTRAMUSCULAR 20110510 ANDA ANDA078347 Cardinal Health HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] 55154-2736_092bdcc2-d001-471c-be6b-64a0d566ec22 55154-2736 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Cardinal Health SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 55154-2750_d3961c03-16e9-4bf1-8bdf-ca9eadb249ad 55154-2750 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl CAPSULE ORAL 20110603 UNAPPROVED DRUG OTHER Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55154-2826_ed00fb78-2339-4b24-9707-99517b477a32 55154-2826 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20100706 ANDA ANDA090808 Cardinal Health HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 55154-2827_ed00fb78-2339-4b24-9707-99517b477a32 55154-2827 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20100706 ANDA ANDA090808 Cardinal Health HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 55154-2828_5f97a41c-2548-42f0-bd65-f683c32b5d86 55154-2828 HUMAN PRESCRIPTION DRUG Clindamycin clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120515 ANDA ANDA090108 Cardinal Health CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 55154-2851_b5ea7434-9908-4707-a640-860e8560dff3 55154-2851 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide INJECTION INTRAMUSCULAR; INTRAVENOUS 20090127 ANDA ANDA079196 Cardinal Health BUMETANIDE .25 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-2852_f5963e2b-4446-4ab4-97f8-6b8b92958de5 55154-2852 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride PHENYLEPHRINE HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100409 UNAPPROVED DRUG OTHER Cardinal Health PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 55154-2857_e0df89e4-1642-4c73-bf8d-9c1d3ac370fc 55154-2857 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101217 NDA NDA017558 Cardinal Health GLYCOPYRROLATE .2 mg/mL 55154-2859_e0df89e4-1642-4c73-bf8d-9c1d3ac370fc 55154-2859 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101217 NDA NDA017558 Cardinal Health GLYCOPYRROLATE .2 mg/mL 55154-2860_8e57779f-bcb1-41a4-aa9e-893c97b3b768 55154-2860 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 Cardinal Health PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-2861_0ba1563f-764c-422d-b1cb-1755483b7084 55154-2861 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 Cardinal Health PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-2867_6010afb7-7f94-4c5e-a93b-1962f071c031 55154-2867 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20100304 ANDA ANDA075243 Cardinal Health MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-2869_e0df89e4-1642-4c73-bf8d-9c1d3ac370fc 55154-2869 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101217 NDA NDA017558 Cardinal Health GLYCOPYRROLATE .2 mg/mL 55154-2872_d337b07d-5d72-428d-ac31-d8afbfd3b44b 55154-2872 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101119 ANDA ANDA077541 Cardinal Health ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-2873_d337b07d-5d72-428d-ac31-d8afbfd3b44b 55154-2873 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101119 ANDA ANDA077541 Cardinal Health ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-2874_6010afb7-7f94-4c5e-a93b-1962f071c031 55154-2874 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20100304 ANDA ANDA075243 Cardinal Health MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-2876_618593fa-daba-47f2-964e-fc264115b98f 55154-2876 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077541 Cardinal Health ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-2877_1f48c280-6302-46eb-8b32-705199a5e08c 55154-2877 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077541 Cardinal Health ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-2878_d402598d-fb7f-4c13-96a2-bdd5f95a18d5 55154-2878 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 Cardinal Health MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-2879_78161062-5a24-4ae5-ae94-29daf3adba58 55154-2879 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 Cardinal Health MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-2881_babc32fe-6454-4c16-b967-8432062db782 55154-2881 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 Cardinal Health GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 55154-2883_78161062-5a24-4ae5-ae94-29daf3adba58 55154-2883 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 Cardinal Health MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-2885_1b8742b5-276d-44e4-9a2a-5bdff9a4dc7d 55154-2885 HUMAN PRESCRIPTION DRUG DEXTROSE DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19710304 NDA NDA016673 Cardinal Health DEXTROSE MONOHYDRATE 50 g/1000mL 55154-2886_0447c2ec-c24f-4619-8218-a8cc5a1f7a68 55154-2886 HUMAN PRESCRIPTION DRUG DEXTROSE DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19710304 ANDA ANDA016673 Cardinal Health DEXTROSE MONOHYDRATE 50 g/1000mL 55154-2887_c8758d46-17c8-4fcd-9a0f-e73a2dad6860 55154-2887 HUMAN PRESCRIPTION DRUG DEXTROSE DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19710304 NDA NDA016673 Cardinal Health DEXTROSE MONOHYDRATE 50 g/1000mL 55154-2888_6dcbdd78-c69d-4d70-81ce-8cb7f7580b48 55154-2888 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride Esmolol Hydrochloride INJECTION INTRAVENOUS 19861231 NDA NDA019386 Cardinal Health ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-2889_728d6ffc-d70f-4146-98ae-dea4e11c6da2 55154-2889 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 Cardinal Health MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-3025_14271670-a13b-4f7d-a27b-a92a27199cc6 55154-3025 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE AcetaZOLAMIDE TABLET ORAL 19970528 ANDA ANDA040195 Cardinal Health ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 55154-3025_bc614baa-8649-4fea-a482-ee121fd3dcd6 55154-3025 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE AcetaZOLAMIDE TABLET ORAL 19970528 ANDA ANDA040195 Cardinal Health ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 55154-3026_6ec56846-8056-4083-818e-92f92f0c71ed 55154-3026 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, EXTENDED RELEASE ORAL 20090331 ANDA ANDA078115 Cardinal Health CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 55154-3027_30f04514-79b5-46a4-a38a-9bf05f7a8c24 55154-3027 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20060905 ANDA ANDA040684 Cardinal Health PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-3029_a20d759b-a705-4aa4-8aac-097d46b2362c 55154-3029 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 Cardinal Health CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 55154-3030_a20d759b-a705-4aa4-8aac-097d46b2362c 55154-3030 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, CHEWABLE ORAL 20001024 ANDA ANDA075687 Cardinal Health CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 55154-3113_adbc5622-f023-4bb0-b942-4eb1bc1b19bb 55154-3113 HUMAN PRESCRIPTION DRUG Valium diazepam TABLET ORAL 19631115 NDA NDA013263 Cardinal Health DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-3114_adbc5622-f023-4bb0-b942-4eb1bc1b19bb 55154-3114 HUMAN PRESCRIPTION DRUG Valium diazepam TABLET ORAL 19631115 NDA NDA013263 Cardinal Health DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-3116_a0a964e0-ffee-4c25-89b0-2d0887fb51f0 55154-3116 HUMAN PRESCRIPTION DRUG Klonopin clonazepam TABLET ORAL 19820101 NDA NDA017533 Cardinal Health CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-3117_a0a964e0-ffee-4c25-89b0-2d0887fb51f0 55154-3117 HUMAN PRESCRIPTION DRUG Klonopin clonazepam TABLET ORAL 19820101 NDA NDA017533 Cardinal Health CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-3122_3123a75c-5967-45cf-8295-0b853945b000 55154-3122 HUMAN PRESCRIPTION DRUG CellCept Mycophenolate mofetil CAPSULE ORAL 19950503 NDA NDA050722 Cardinal Health MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 55154-3182_76df87ae-c15c-4a03-8a1c-6cfa3ae871c9 55154-3182 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine lidocaine hydrochloride anhydrous and epinephrine INJECTION, SOLUTION INFILTRATION 20100405 ANDA ANDA089646 Cardinal Health EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 10; 20 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-3183_ac69a744-6f69-4191-be12-a8f1d94abd9a 55154-3183 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAVENOUS 19821029 NDA NDA018800 Cardinal Health SODIUM CHLORIDE 9 mg/mL 55154-3184_c71eee24-acd2-436f-bf06-44358e602bf8 55154-3184 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20070509 ANDA ANDA065345 Cardinal Health CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-3185_f7654b0c-085a-4dd2-a242-577acedbfe0a 55154-3185 HUMAN PRESCRIPTION DRUG LEVOPHED Norepinephrine Bitartrate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19820101 NDA NDA007513 Cardinal Health NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-3186_e609bab7-c671-424d-bd9d-ced0affa0b4d 55154-3186 HUMAN PRESCRIPTION DRUG Epinephrine EPINEPHRINE INJECTION, SOLUTION ENDOTRACHEAL; INTRACARDIAC; INTRAVENOUS 19850405 UNAPPROVED DRUG OTHER Cardinal Health EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-3187_afd7c91b-3283-49e7-b79f-1c8d0c1a53bd 55154-3187 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA080408 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-3188_119e57a4-377a-46cd-bace-a11cc3addfa1 55154-3188 HUMAN PRESCRIPTION DRUG Calcium Chloride CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS; INTRAVENTRICULAR 19840917 UNAPPROVED DRUG OTHER Cardinal Health CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 55154-3189_2c6df9ea-251f-493e-a930-a4f76f59868b 55154-3189 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20101129 ANDA ANDA040302 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-3190_2c6df9ea-251f-493e-a930-a4f76f59868b 55154-3190 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20101129 ANDA ANDA083158 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-3191_2c6df9ea-251f-493e-a930-a4f76f59868b 55154-3191 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20101129 ANDA ANDA040302 Cardinal Health LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-3192_bd8d7981-e238-458a-aef0-47cf76fc5816 55154-3192 HUMAN PRESCRIPTION DRUG Mannitol MANNITOL INJECTION, SOLUTION INTRAVENOUS 20100201 ANDA ANDA016269 Cardinal Health MANNITOL 12.5 g/50mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 55154-3193_39f1622e-b599-44a4-bfa9-d11a9a910f23 55154-3193 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19881120 ANDA ANDA040140 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 55154-3194_4a4e2de6-97c3-4afc-a486-dffd2c81ea67 55154-3194 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION 20091117 ANDA ANDA040078 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-3195_e609bab7-c671-424d-bd9d-ced0affa0b4d 55154-3195 HUMAN PRESCRIPTION DRUG Epinephrine EPINEPHRINE INJECTION, SOLUTION ENDOTRACHEAL; INTRACARDIAC; INTRAVENOUS 19850501 UNAPPROVED DRUG OTHER Cardinal Health EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-3196_e02ead36-7d3e-45ac-8f6d-908cf6f0a029 55154-3196 HUMAN PRESCRIPTION DRUG Calcium Chloride CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110309 NDA NDA021117 Cardinal Health CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 55154-3197_1c70c967-d9d5-4bf9-a4ed-76336d93e449 55154-3197 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 19850418 UNAPPROVED DRUG OTHER Cardinal Health SODIUM BICARBONATE 84 mg/mL 55154-3198_9ad5e836-33bf-49c9-a530-296cff30d1c7 55154-3198 HUMAN PRESCRIPTION DRUG Nalbuphine Hydrochloride Nalbuphine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19890203 ANDA ANDA070914 Cardinal Health NALBUPHINE HYDROCHLORIDE 10 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] 55154-3226_c5d7489a-4bcb-4323-b4a9-ab2f35dd67bd 55154-3226 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110502 ANDA ANDA040573 Cardinal Health PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-3255_e274c6d8-65f1-4b4c-aba7-c82c4d7e0288 55154-3255 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20100615 ANDA ANDA040644 Cardinal Health CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 55154-3275_dfb8cd15-e468-4082-8e68-4f1d4ad7f283 55154-3275 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone ELIXIR ORAL 19830727 ANDA ANDA088254 Cardinal Health DEXAMETHASONE .5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-3276_879b77c7-c813-4d75-8ab3-6903dcc8d358 55154-3276 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate PREDNISOLONE SODIUM PHOSPHATE SOLUTION ORAL 20041004 ANDA ANDA076895 Cardinal Health PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-3278_1ee5f107-ef01-489e-adc3-16bb91a50dad 55154-3278 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SYRUP ORAL 19821115 ANDA ANDA087953 Cardinal Health PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-3325_3f0db644-694b-4af4-8b91-09793947196c 55154-3325 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20040803 ANDA ANDA065095 Cardinal Health DOXYCYCLINE HYCLATE 100 mg/1 55154-3326_b04c23ee-3165-4eb7-86a9-ca457747539e 55154-3326 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20100504 ANDA ANDA075757 Cardinal Health OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55154-3327_f6cb5d3d-b65b-470b-98ab-9d3f1fd9a438 55154-3327 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080402 ANDA ANDA074342 Cardinal Health ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-3328_ca07d43a-05e5-44c6-9336-b398a13e69d3 55154-3328 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20090825 ANDA ANDA075604 Cardinal Health POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55154-3329_22d35e95-719c-4d5a-8c16-15a522b01e58 55154-3329 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20091102 ANDA ANDA078216 Cardinal Health CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-3330_5d0efc2b-9ab4-4e7d-9283-01b0ec035d6c 55154-3330 HUMAN PRESCRIPTION DRUG Pantoprazole Pantoprazole TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA077619 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55154-3331_8a43ac4e-efb5-4d8b-90cb-ce351bff754e 55154-3331 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Cardinal Health LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-3332_4c3bd5be-5d46-42f2-8765-a397cbde2f88 55154-3332 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE, GELATIN COATED ORAL 20100510 ANDA ANDA078938 Cardinal Health TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55154-3333_fdde5932-9a93-48a7-b0f2-68d294754f4b 55154-3333 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20100301 ANDA ANDA076003 Cardinal Health TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 55154-3334_254d5264-bc8e-4506-8145-cffa4479ef31 55154-3334 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET ORAL 20110623 ANDA ANDA090367 Cardinal Health LEVOFLOXACIN 750 mg/1 55154-3335_254d5264-bc8e-4506-8145-cffa4479ef31 55154-3335 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET ORAL 20110623 ANDA ANDA090367 Cardinal Health LEVOFLOXACIN 500 mg/1 55154-3336_8a43ac4e-efb5-4d8b-90cb-ce351bff754e 55154-3336 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Cardinal Health LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-3337_254d5264-bc8e-4506-8145-cffa4479ef31 55154-3337 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET ORAL 20110623 ANDA ANDA090367 Cardinal Health LEVOFLOXACIN 250 mg/1 55154-3338_f13b6e92-52cb-4383-b42a-bb0a236c8998 55154-3338 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110607 ANDA ANDA091267 Cardinal Health DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55154-3342_b6625089-0629-4f6e-8164-0b582c56d475 55154-3342 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120315 ANDA ANDA077565 Cardinal Health ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 55154-3343_b6625089-0629-4f6e-8164-0b582c56d475 55154-3343 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120315 ANDA ANDA077565 Cardinal Health ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 55154-3344_b6625089-0629-4f6e-8164-0b582c56d475 55154-3344 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120315 ANDA ANDA077565 Cardinal Health ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 55154-3346_8a43ac4e-efb5-4d8b-90cb-ce351bff754e 55154-3346 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Cardinal Health LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-3348_f4014cd1-15c3-413b-a5cd-330e7417144e 55154-3348 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20080228 ANDA ANDA076048 Cardinal Health OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55154-3349_22d35e95-719c-4d5a-8c16-15a522b01e58 55154-3349 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20091102 ANDA ANDA078216 Cardinal Health CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-3350_78162da6-ad65-4dd8-ab1a-6f77670fede9 55154-3350 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20080801 ANDA ANDA076341 Cardinal Health PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-3376_1781ceab-620c-4e3c-8222-cc7893a23217 55154-3376 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET ORAL 20120517 ANDA ANDA090844 Cardinal Health CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 55154-3377_f58abc7f-4cae-4301-9be3-968cf690c14e 55154-3377 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090820 ANDA ANDA078705 Cardinal Health DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-3378_f13b6e92-52cb-4383-b42a-bb0a236c8998 55154-3378 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110607 ANDA ANDA091267 Cardinal Health DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55154-3379_4cd7ef44-1b61-4d4a-95c6-b897899b1fcc 55154-3379 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Cardinal Health QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 55154-3380_4cd7ef44-1b61-4d4a-95c6-b897899b1fcc 55154-3380 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Cardinal Health QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 55154-3381_4cd7ef44-1b61-4d4a-95c6-b897899b1fcc 55154-3381 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Cardinal Health QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 55154-3382_e1905561-7322-4839-acab-93301ddf03c9 55154-3382 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110607 ANDA ANDA078865 Cardinal Health VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-3383_e1905561-7322-4839-acab-93301ddf03c9 55154-3383 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110607 ANDA ANDA078865 Cardinal Health VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-3384_b6625089-0629-4f6e-8164-0b582c56d475 55154-3384 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120315 ANDA ANDA077565 Cardinal Health ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 55154-3386_946133ff-67c8-4d3f-8dd4-6d1e72f87f1d 55154-3386 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19980721 ANDA ANDA072235 Cardinal Health BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 55154-3387_8ec58698-6b12-4c33-8285-737bf11798de 55154-3387 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20081030 ANDA ANDA040733 Cardinal Health DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 55154-3388_762a6a26-0c95-4023-960c-5e46d213253d 55154-3388 HUMAN OTC DRUG Bisacodyl Bisacodyl TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health BISACODYL 5 mg/1 55154-3392_a27c8d30-fa25-4927-86fd-fdcfec8fd03a 55154-3392 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20090610 ANDA ANDA078500 Cardinal Health AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-3394_105e5e20-8501-461e-b9cc-50e05b879157 55154-3394 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Cardinal Health SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-3395_105e5e20-8501-461e-b9cc-50e05b879157 55154-3395 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Cardinal Health SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-3396_1aec8379-bd0d-45b3-8411-df650ccc6b3f 55154-3396 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20080326 NDA NDA018569 Cardinal Health FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-3397_ed356600-1b7e-418f-8f91-cece10a6ff7a 55154-3397 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20090810 ANDA ANDA075927 Cardinal Health NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-3416_d63959d5-b1dc-4422-8f69-7599f8b11f4a 55154-3416 HUMAN PRESCRIPTION DRUG Fioricet Butalbital, Acetaminophen, and Caffeine TABLET ORAL 19841109 ANDA ANDA088616 Cardinal Health ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 55154-3418_139cec0c-481d-4a41-89dd-d51f236cc5cc 55154-3418 HUMAN PRESCRIPTION DRUG Neoral cyclosporine CAPSULE, LIQUID FILLED ORAL 19950714 NDA NDA050715 Cardinal Health CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 55154-3424_076ed195-253b-4b31-8a92-f134dfee6315 55154-3424 HUMAN PRESCRIPTION DRUG Clozaril clozapine TABLET ORAL 19890930 NDA NDA019758 Cardinal Health CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] 55154-3425_990afabe-cafa-4e10-ac37-c5f93b7af592 55154-3425 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Cardinal Health VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-3428_66d63267-2eb7-4024-9061-a976168a9f06 55154-3428 HUMAN PRESCRIPTION DRUG Comtan entacapone TABLET, FILM COATED ORAL 20000101 NDA NDA020796 Cardinal Health ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 55154-3429_5998c33c-5053-4bfd-9732-3acd5f56112e 55154-3429 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 19951130 ANDA ANDA040104 Cardinal Health HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 55154-3430_2b55e178-987d-4ab7-b12b-be9ab2588292 55154-3430 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Cardinal Health CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-3431_2b55e178-987d-4ab7-b12b-be9ab2588292 55154-3431 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Cardinal Health CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-3432_2350a1d6-ac93-45e3-a07e-3a8ca62fcedd 55154-3432 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065211 Cardinal Health AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55154-3434_716bf76f-ae98-498d-8960-0b35aa90c92b 55154-3434 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19951130 ANDA ANDA074394 Cardinal Health DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-3436_34f6e21e-f6fc-4426-b5fb-1abe97faa7ac 55154-3436 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20030128 ANDA ANDA075757 Cardinal Health OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55154-3437_cb7720c1-c4ff-46b8-a36b-b6fe4f8e34bc 55154-3437 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Cardinal Health METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 55154-3445_2b673d8e-d16e-4a73-b7e3-0f1cc1f058df 55154-3445 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19880112 ANDA ANDA071427 Cardinal Health TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-3446_2b673d8e-d16e-4a73-b7e3-0f1cc1f058df 55154-3446 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19880112 ANDA ANDA071428 Cardinal Health TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-3448_31d13e08-b54f-469e-88d3-c96b2c5bc05d 55154-3448 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA077322 Cardinal Health ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55154-3449_31d13e08-b54f-469e-88d3-c96b2c5bc05d 55154-3449 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA077322 Cardinal Health ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55154-3476_0fcdd59a-906b-43df-9c65-97d8a736b4f1 55154-3476 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Cardinal Health SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-3477_0fcdd59a-906b-43df-9c65-97d8a736b4f1 55154-3477 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Cardinal Health SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-3478_0fcdd59a-906b-43df-9c65-97d8a736b4f1 55154-3478 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Cardinal Health SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-3479_69432e5f-cd08-4709-989c-841510ed001c 55154-3479 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081024 ANDA ANDA076879 Cardinal Health RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 55154-3480_69432e5f-cd08-4709-989c-841510ed001c 55154-3480 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081024 ANDA ANDA076879 Cardinal Health RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 55154-3481_69432e5f-cd08-4709-989c-841510ed001c 55154-3481 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081024 ANDA ANDA076879 Cardinal Health RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 55154-3482_69432e5f-cd08-4709-989c-841510ed001c 55154-3482 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081024 ANDA ANDA076879 Cardinal Health RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 55154-3483_69432e5f-cd08-4709-989c-841510ed001c 55154-3483 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081024 ANDA ANDA076879 Cardinal Health RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 55154-3484_69432e5f-cd08-4709-989c-841510ed001c 55154-3484 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081024 ANDA ANDA076879 Cardinal Health RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 55154-3486_0fcdd59a-906b-43df-9c65-97d8a736b4f1 55154-3486 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Cardinal Health SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-3487_6b6a34e2-4de2-4dd0-adca-40f32f8d854c 55154-3487 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Cardinal Health TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55154-3488_5c00ae98-aaea-4c67-b8a8-71be09920b06 55154-3488 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA091023 Cardinal Health CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 55154-3495_b711895f-e3d4-43f2-9a3d-1841825fca21 55154-3495 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20061226 ANDA ANDA076183 Cardinal Health ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-3516_7b5ccc4a-e2bb-46b0-b549-5a223e5a588f 55154-3516 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride TABLET, FILM COATED ORAL 20100302 NDA NDA021085 Cardinal Health MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55154-3526_abcfeec6-7f3a-4139-a6e6-fa42dafd8264 55154-3526 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 19881208 ANDA ANDA089683 Cardinal Health PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-3528_7e1568e0-a1a3-47bb-84a1-f7515cac8c83 55154-3528 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19981120 ANDA ANDA074726 Cardinal Health POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55154-3529_e971f2b3-2d12-42b6-b101-5a75fd84facc 55154-3529 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Cardinal Health POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55154-3530_7e1568e0-a1a3-47bb-84a1-f7515cac8c83 55154-3530 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19981120 ANDA ANDA074726 Cardinal Health POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55154-3534_f7c6d0b0-023d-4493-a5b4-d12256b27c0b 55154-3534 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070103 ANDA ANDA071403 Cardinal Health LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-3535_f7c6d0b0-023d-4493-a5b4-d12256b27c0b 55154-3535 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 Cardinal Health LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-3575_7b638526-93a4-4a35-bd8c-787ec9c293dd 55154-3575 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Cardinal Health GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-3596_b3cf7997-9287-4f7d-8e10-cc2c061e95dd 55154-3596 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120222 ANDA ANDA090796 Cardinal Health IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-3613_a654ce16-6d93-4169-9434-6e9dbd7a661d 55154-3613 HUMAN PRESCRIPTION DRUG Cytotec misoprostol TABLET ORAL 19881227 NDA NDA019268 Cardinal Health MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 55154-3621_839cbcbd-7642-4971-873b-801863c48b5f 55154-3621 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Cardinal Health CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-3622_839cbcbd-7642-4971-873b-801863c48b5f 55154-3622 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Cardinal Health CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-3624_a654ce16-6d93-4169-9434-6e9dbd7a661d 55154-3624 HUMAN PRESCRIPTION DRUG Cytotec misoprostol TABLET ORAL 19881227 NDA NDA019268 Cardinal Health MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 55154-3625_fe16ecb3-621c-4dbb-92e6-9e636b75ab84 55154-3625 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Cardinal Health CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-3650_bc98621b-1cd5-4ee8-9f15-f90946dd39a9 55154-3650 HUMAN PRESCRIPTION DRUG Skelaxin Metaxalone TABLET ORAL 20020830 NDA NDA013217 Cardinal Health METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55154-3675_33e98d79-97c4-4da4-83db-e369595cc174 55154-3675 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55154-3676_78ca64de-2e46-46ce-8fbb-929de1ad3aee 55154-3676 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Cardinal Health CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55154-3677_78ca64de-2e46-46ce-8fbb-929de1ad3aee 55154-3677 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Cardinal Health CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55154-3678_78ca64de-2e46-46ce-8fbb-929de1ad3aee 55154-3678 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Cardinal Health CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55154-3679_78ca64de-2e46-46ce-8fbb-929de1ad3aee 55154-3679 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Cardinal Health CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55154-3680_3c34ca82-9705-4784-be7c-8b50351d14fc 55154-3680 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Cardinal Health ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-3682_155d9cbb-c74c-49b0-840d-fd79c0f13e4f 55154-3682 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Cardinal Health CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55154-3683_c5aea808-1c2f-4729-9cfe-ec5886457937 55154-3683 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Cardinal Health ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-3684_674f9725-7d68-4b9a-97d9-e9abc6a4e7cd 55154-3684 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 Cardinal Health PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-3685_674f9725-7d68-4b9a-97d9-e9abc6a4e7cd 55154-3685 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 Cardinal Health PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-3725_427a1c27-47e1-4ee0-aca5-3098bb1938c9 55154-3725 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 Cardinal Health GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-3726_427a1c27-47e1-4ee0-aca5-3098bb1938c9 55154-3726 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 Cardinal Health GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-3727_427a1c27-47e1-4ee0-aca5-3098bb1938c9 55154-3727 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 Cardinal Health GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-3728_9b3adf55-3542-4729-b481-c2e538f7cf06 55154-3728 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070727 ANDA ANDA077851 Cardinal Health ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-3775_496cef7f-7fd4-439d-b103-35faaf3df1a7 55154-3775 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Cardinal Health ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-3776_496cef7f-7fd4-439d-b103-35faaf3df1a7 55154-3776 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Cardinal Health ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-3777_496cef7f-7fd4-439d-b103-35faaf3df1a7 55154-3777 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Cardinal Health ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-3825_8b63536f-41b0-4eb4-b005-68dcb562676f 55154-3825 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070103 ANDA ANDA071403 Cardinal Health LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-3826_8b63536f-41b0-4eb4-b005-68dcb562676f 55154-3826 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 Cardinal Health LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-3828_29a1dcbf-df45-4dc7-8b74-d7984f014b35 55154-3828 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 19930903 ANDA ANDA074260 Cardinal Health CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 55154-3875_c8e25035-6a90-48cc-a68f-3994eacc218c 55154-3875 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20050105 NDA NDA021518 Cardinal Health SOLIFENACIN SUCCINATE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-3876_c8e25035-6a90-48cc-a68f-3994eacc218c 55154-3876 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20050105 NDA NDA021518 Cardinal Health SOLIFENACIN SUCCINATE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-3877_16c4b492-8aac-42e9-98c8-4eea04da63e2 55154-3877 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20050105 NDA NDA021518 Cardinal Health SOLIFENACIN SUCCINATE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-3878_16c4b492-8aac-42e9-98c8-4eea04da63e2 55154-3878 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20050105 NDA NDA021518 Cardinal Health SOLIFENACIN SUCCINATE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-3914_8e9ff305-0e0c-414e-add1-df9491bd94c1 55154-3914 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Cardinal Health METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-3915_8e9ff305-0e0c-414e-add1-df9491bd94c1 55154-3915 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Cardinal Health METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-3925_b2b4c961-363d-49fe-b354-d59b39fd517a 55154-3925 HUMAN PRESCRIPTION DRUG SOLU-CORTEF hydrocortisone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVASCULAR 19550427 NDA NDA009866 Cardinal Health HYDROCORTISONE SODIUM SUCCINATE 100 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-3929_915001a5-1a6f-4ef1-b587-82bba0e24844 55154-3929 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 19590528 NDA NDA011757 Cardinal Health METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-3932_915001a5-1a6f-4ef1-b587-82bba0e24844 55154-3932 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 19590528 NDA NDA011757 Cardinal Health METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-3933_6edc32e3-89ec-439b-9ddc-eec4cf4d820a 55154-3933 HUMAN PRESCRIPTION DRUG Detrol LA tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20001222 NDA NDA021228 Cardinal Health TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-3935_6edc32e3-89ec-439b-9ddc-eec4cf4d820a 55154-3935 HUMAN PRESCRIPTION DRUG Detrol LA tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20001222 NDA NDA021228 Cardinal Health TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-3938_d76293c8-2642-4bfc-97bf-59e37251723d 55154-3938 HUMAN PRESCRIPTION DRUG Zyvox linezolid TABLET, FILM COATED ORAL 20000418 NDA NDA021130 Cardinal Health LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] 55154-3939_d35acefc-bf42-4d52-a1d2-ae2069f9dcf5 55154-3939 HUMAN PRESCRIPTION DRUG Solu-Medrol methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Cardinal Health METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-3940_a305d225-6cff-40cc-b8f9-313194d9da94 55154-3940 HUMAN PRESCRIPTION DRUG Solu-Medrol methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Cardinal Health METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-3941_a305d225-6cff-40cc-b8f9-313194d9da94 55154-3941 HUMAN PRESCRIPTION DRUG Solu-Medrol methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Cardinal Health METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-3942_49afcf8e-f8ad-4b9a-9740-331fb1fd11d7 55154-3942 HUMAN PRESCRIPTION DRUG Solu-Cortef hydrocortisone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19550427 NDA NDA009866 Cardinal Health HYDROCORTISONE SODIUM SUCCINATE 100 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-3944_5cd647f2-b283-47c8-9fb1-e9f0410e622d 55154-3944 HUMAN PRESCRIPTION DRUG Solu-Medrol methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Cardinal Health METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-3950_3782bd67-1774-4b93-a08b-e6beb16827ae 55154-3950 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-3951_3782bd67-1774-4b93-a08b-e6beb16827ae 55154-3951 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-3952_d5c08694-4710-4785-a3db-58f5033d8264 55154-3952 HUMAN PRESCRIPTION DRUG Phytonadione Phytonadione INJECTION, EMULSION PARENTERAL 20030418 ANDA ANDA083722 Cardinal Health PHYTONADIONE 1 mg/.5mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 55154-3953_8d7f9ecb-a0d6-4800-8136-c47fa87c0d55 55154-3953 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-3954_7a3bb6db-ee60-46c6-a78e-7a6cb45c7ed8 55154-3954 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION PARENTERAL 20010601 ANDA ANDA072076 Cardinal Health NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 55154-3955_8d7f9ecb-a0d6-4800-8136-c47fa87c0d55 55154-3955 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-3977_16b6309d-0a18-42d7-b39a-bafe863aae48 55154-3977 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200270 Cardinal Health ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 55154-4024_d50dfe83-39a3-48ec-829f-07cd617679c1 55154-4024 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 30 mg/.3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-4028_d50dfe83-39a3-48ec-829f-07cd617679c1 55154-4028 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-4029_d50dfe83-39a3-48ec-829f-07cd617679c1 55154-4029 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-4030_d50dfe83-39a3-48ec-829f-07cd617679c1 55154-4030 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-4031_d50dfe83-39a3-48ec-829f-07cd617679c1 55154-4031 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-4033_c3419e39-835c-441a-941c-0cc250e02216 55154-4033 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-4034_c3419e39-835c-441a-941c-0cc250e02216 55154-4034 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-4035_c3419e39-835c-441a-941c-0cc250e02216 55154-4035 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-4036_c3419e39-835c-441a-941c-0cc250e02216 55154-4036 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-4037_c3419e39-835c-441a-941c-0cc250e02216 55154-4037 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 30 mg/.3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-4055_cc68cd50-174b-41fb-934b-d87ceb449cc1 55154-4055 HUMAN PRESCRIPTION DRUG LACTULOSE LACTULOSE SOLUTION ORAL 20100510 ANDA ANDA074138 Cardinal Health LACTULOSE 20 g/30mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 55154-4056_201610d3-ae28-4cfb-91f4-22b69e460c38 55154-4056 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20100510 ANDA ANDA064142 Cardinal Health NYSTATIN 100000 [USP&apos'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 55154-4057_d72083ee-abaf-4f27-bd4c-d67ddbff4e67 55154-4057 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate SUSPENSION ORAL 20120816 NDA NDA019183 Cardinal Health SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 55154-4058_0d41e820-f8d9-4ef3-b47f-08e2bc78191a 55154-4058 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen SOLUTION ORAL 20120220 ANDA ANDA200343 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-4179_f0bbf8c0-8c80-49d5-816d-0b5a89e50ff2 55154-4179 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Cardinal Health HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-4180_f0bbf8c0-8c80-49d5-816d-0b5a89e50ff2 55154-4180 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Cardinal Health HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-4181_6bb8fc5a-28e5-4d82-8454-1ecb08a6adc9 55154-4181 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Cardinal Health HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-4209_36c1472b-565e-480c-ba3a-5eefe2b641ea 55154-4209 HUMAN PRESCRIPTION DRUG Ativan lorazepam TABLET ORAL 20100316 NDA NDA017794 Cardinal Health LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-4217_88f65ad5-54c5-45f2-8c7a-0a70af606589 55154-4217 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20000501 NDA NDA020987 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55154-4218_1f8f63a5-0e05-4643-8f9a-ee1292931451 55154-4218 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Cardinal Health VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-4219_1f8f63a5-0e05-4643-8f9a-ee1292931451 55154-4219 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Cardinal Health VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-4223_1f8f63a5-0e05-4643-8f9a-ee1292931451 55154-4223 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Cardinal Health VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-4225_ff264bd9-454b-4611-8dcd-612227b9b91e 55154-4225 HUMAN PRESCRIPTION DRUG Protonix I.V. pantoprazole sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20010501 NDA NDA020988 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55154-4226_88f65ad5-54c5-45f2-8c7a-0a70af606589 55154-4226 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20000501 NDA NDA020987 Cardinal Health PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55154-4227_0f26220a-f4ab-4ceb-9a98-a13dbdeed81f 55154-4227 HUMAN PRESCRIPTION DRUG Rapamune Sirolimus TABLET, SUGAR COATED ORAL 20010701 NDA NDA021110 Cardinal Health SIROLIMUS 1 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA] 55154-4228_db7aa1c2-22e6-492f-81ba-5ecbb8836ac0 55154-4228 HUMAN PRESCRIPTION DRUG Zosyn piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19931101 NDA NDA050684 Cardinal Health PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 55154-4230_3ab5ee97-172a-4beb-b843-5e272b2721e3 55154-4230 HUMAN PRESCRIPTION DRUG Pristiq Extended-Release desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20080501 NDA NDA021992 Cardinal Health DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 55154-4231_903a60c9-d464-4665-8575-553218f97186 55154-4231 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20080131 NDA NDA020987 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55154-4232_88f65ad5-54c5-45f2-8c7a-0a70af606589 55154-4232 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release pantoprazole sodium GRANULE, DELAYED RELEASE ORAL 20080229 NDA NDA022020 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55154-4233_15a606c5-e396-4b1f-aec6-0b92080b7e2b 55154-4233 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20080131 NDA NDA020987 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55154-4234_ce1759fd-ed92-4488-91ed-dac807a67e08 55154-4234 HUMAN PRESCRIPTION DRUG Protonix I.V. pantoprazole sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20010501 NDA NDA020988 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/10mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55154-4235_3ab5ee97-172a-4beb-b843-5e272b2721e3 55154-4235 HUMAN PRESCRIPTION DRUG Pristiq Extended-Release desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20080501 NDA NDA021992 Cardinal Health DESVENLAFAXINE SUCCINATE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 55154-4236_50802e19-72d3-4130-8d14-eb94361b38e7 55154-4236 HUMAN PRESCRIPTION DRUG Protonix I.V. PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20010501 NDA NDA020988 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/10mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55154-4250_a91f6d42-e74e-461b-af00-44a118ecc502 55154-4250 HUMAN PRESCRIPTION DRUG Cardizem diltiazem hydrochloride CAPSULE ORAL 20010411 NDA NDA020062 Cardinal Health DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-4251_a91f6d42-e74e-461b-af00-44a118ecc502 55154-4251 HUMAN PRESCRIPTION DRUG Cardizem diltiazem hydrochloride CAPSULE ORAL 20010411 NDA NDA020062 Cardinal Health DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-4325_16d4ec47-fbfe-4c18-b0fe-d4def625b4c3 55154-4325 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20110805 ANDA ANDA040782 Cardinal Health DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 55154-4326_c6b1bbe5-78b0-407f-b953-92a131e3a4aa 55154-4326 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110607 ANDA ANDA078500 Cardinal Health AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-4327_9d8d65fc-a28c-47e8-a8ca-eea8ccffea54 55154-4327 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20110520 ANDA ANDA065404 Cardinal Health AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55154-4329_fbba8a99-51d5-4d7d-9fd6-8ac81ef3c989 55154-4329 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20130502 ANDA ANDA075090 Cardinal Health ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55154-4330_e4125bf0-3c1c-4416-bcb7-bf27c3792d28 55154-4330 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20130115 ANDA ANDA078281 Cardinal Health PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55154-4331_e39915e4-605a-444b-be98-abf8409bd2e7 55154-4331 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140110 ANDA ANDA078552 Cardinal Health AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-4332_e369bb68-c6d6-4a74-9ed7-dd8c30b7672b 55154-4332 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19990305 ANDA ANDA075382 Cardinal Health ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55154-4333_fd5c0ebe-b0ee-422c-8980-bfc153f55a06 55154-4333 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20140326 ANDA ANDA065507 Cardinal Health AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55154-4350_2b8673cc-2c00-4519-88d8-6a645400719a 55154-4350 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20010626 ANDA ANDA075664 Cardinal Health ALBUTEROL SULFATE 2.5 mg/.5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 55154-4351_f8b04664-777d-478a-bb56-621845e3cb99 55154-4351 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20010927 ANDA ANDA075562 Cardinal Health IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 55154-4357_543d5d48-5ac1-4895-9d7d-29028c523c00 55154-4357 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20071231 ANDA ANDA076749 Cardinal Health ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 2.5; .5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 55154-4358_47b29437-b0c6-4fba-a4da-428f6e04a366 55154-4358 HUMAN OTC DRUG Sodium Chloride Sodium Chloride INHALANT RESPIRATORY (INHALATION) 20110607 UNAPPROVED DRUG OTHER Cardinal Health SODIUM CHLORIDE .9 mg/100mL 55154-4359_e5419eba-0633-4214-9b09-f02d8d59c6a8 55154-4359 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19970917 ANDA ANDA074880 Cardinal Health ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 55154-4360_52d729bc-dcb2-4396-8bb3-2d549fe49af6 55154-4360 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20040628 ANDA ANDA076355 Cardinal Health ALBUTEROL SULFATE 1.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 55154-4375_9b92e2a1-2844-4fe6-89bf-3f40561887fb 55154-4375 HUMAN OTC DRUG Loratadine loratadine TABLET ORAL 20130430 ANDA ANDA076154 Cardinal Health LORATADINE 10 mg/1 55154-4376_d528bd13-4a7d-43be-b0a5-64ba92ee3d03 55154-4376 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20101029 ANDA ANDA076187 Cardinal Health LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-4377_d528bd13-4a7d-43be-b0a5-64ba92ee3d03 55154-4377 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20101029 ANDA ANDA076187 Cardinal Health LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-4378_7eeaa7bc-c94f-47d0-94e5-e35ccadca19e 55154-4378 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20140102 ANDA ANDA070184 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 55154-4379_444a743a-4843-4b33-bad5-3dfc1fb2d004 55154-4379 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20130924 ANDA ANDA070848 Cardinal Health SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 55154-4380_717becab-45bd-4b4d-886e-78506461b9e7 55154-4380 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, FILM COATED ORAL 20120829 ANDA ANDA079103 Cardinal Health MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 55154-4381_0ef67d2f-375b-494b-9eeb-56d1ff4f2201 55154-4381 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090203 ANDA ANDA077567 Cardinal Health DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-4425_a4420bef-e316-412b-9268-be6630fd07d8 55154-4425 HUMAN PRESCRIPTION DRUG TRUVADA emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20040802 NDA NDA021752 Cardinal Health EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 55154-4426_3b86d560-36f3-479e-8967-00f3d3672e72 55154-4426 HUMAN PRESCRIPTION DRUG Viread tenofovir disoproxil fumarate TABLET, COATED ORAL 20011026 NDA NDA021356 Cardinal Health TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 55154-4427_ac529edf-5634-49fa-8db5-ba3a39763161 55154-4427 HUMAN PRESCRIPTION DRUG Ranexa ranolazine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070212 NDA NDA021526 Cardinal Health RANOLAZINE 500 mg/1 Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 55154-4428_0c073e1d-cbef-42d8-bef2-cd965a14251f 55154-4428 HUMAN PRESCRIPTION DRUG Ranexa ranolazine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060127 NDA NDA021526 Cardinal Health RANOLAZINE 500 mg/1 Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 55154-4450_0b8896b6-b8ac-4d04-9d5f-60c21404e159 55154-4450 HUMAN PRESCRIPTION DRUG Norepinephrine bitartrate Norepinephrine bitartrate INJECTION INTRAVENOUS 20120401 ANDA ANDA040859 Cardinal Health NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-4510_7330f40d-b269-425b-a4e3-e7263a088fb7 55154-4510 HUMAN PRESCRIPTION DRUG DYAZIDE hydrochlorothiazide and triamterene CAPSULE ORAL 19940330 NDA NDA016042 Cardinal Health HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 55154-4511_7b97ac91-9ed6-4cca-a517-fb1c2b3d0e46 55154-4511 HUMAN PRESCRIPTION DRUG AUGMENTIN amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19840806 NDA NDA050564 Cardinal Health AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 55154-4513_5abdce6e-3416-439b-8af1-77ee679f0ab2 55154-4513 HUMAN PRESCRIPTION DRUG AVANDIA rosiglitazone maleate TABLET, FILM COATED ORAL 19990529 NDA NDA021071 Cardinal Health ROSIGLITAZONE MALEATE 4 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 55154-4518_5abdce6e-3416-439b-8af1-77ee679f0ab2 55154-4518 HUMAN PRESCRIPTION DRUG AVANDIA rosiglitazone maleate TABLET, FILM COATED ORAL 19990528 NDA NDA021071 Cardinal Health ROSIGLITAZONE MALEATE 8 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 55154-4519_91b240f2-856c-44cf-a3de-a6ead2891f0d 55154-4519 HUMAN OTC DRUG Tums Calcium Carbonate TABLET ORAL 20110615 UNAPPROVED DRUG OTHER Cardinal Health CALCIUM CARBONATE 500 mg/1 55154-4522_c142ab8f-fa5c-471a-a49a-058ab8ec023b 55154-4522 HUMAN PRESCRIPTION DRUG BACTROBAN mupirocin calcium OINTMENT TOPICAL 19960410 NDA NDA050703 Cardinal Health MUPIROCIN CALCIUM 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 55154-4550_4d47d787-4cfd-4b2e-ba08-452168eff880 55154-4550 HUMAN PRESCRIPTION DRUG Myambutol Ethambutol Hydrochloride TABLET ORAL 20110627 NDA NDA016320 Cardinal Health ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] 55154-4551_eedb209a-a587-44a7-b7a5-19dbf9efd280 55154-4551 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Cardinal Health METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-4552_3c7b2832-44fb-42eb-acb9-374346505e84 55154-4552 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20040422 ANDA ANDA076541 Cardinal Health MIRTAZAPINE 15 mg/1 55154-4558_eedb209a-a587-44a7-b7a5-19dbf9efd280 55154-4558 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Cardinal Health METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-4559_3c7b2832-44fb-42eb-acb9-374346505e84 55154-4559 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20040422 ANDA ANDA076541 Cardinal Health MIRTAZAPINE 30 mg/1 55154-4560_46027830-8992-457c-a448-88de995b4a00 55154-4560 HUMAN PRESCRIPTION DRUG Nimodipine Nimodipine CAPSULE ORAL 20070628 ANDA ANDA077067 Cardinal Health NIMODIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-4563_0c965ac3-c462-4777-9482-569193bc880e 55154-4563 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20040115 ANDA ANDA076670 Cardinal Health METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-4564_005a1ebe-bccf-47ce-a203-656854c70961 55154-4564 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Cardinal Health METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-4566_bd36f942-6fb1-4afa-b6b9-8ca8c3cf4530 55154-4566 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 Cardinal Health TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 55154-4567_26aff90c-49ea-46ac-bbf3-c188c2b061c9 55154-4567 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Cardinal Health ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-4568_043db807-8381-4df8-b3a3-825988d63ef5 55154-4568 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE ORAL 20070823 ANDA ANDA077828 Cardinal Health CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 55154-4575_d8aac420-c0d3-495a-9f23-775d17d1eaa2 55154-4575 HUMAN PRESCRIPTION DRUG Prandin repaglinide TABLET ORAL 20000103 NDA NDA020741 Cardinal Health REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 55154-4604_510e9cc4-0529-4c28-b6e6-180e2e47d17d 55154-4604 HUMAN PRESCRIPTION DRUG Tiazac Extended Release diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090924 NDA NDA020401 Cardinal Health DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-4605_510e9cc4-0529-4c28-b6e6-180e2e47d17d 55154-4605 HUMAN PRESCRIPTION DRUG Tiazac Extended Release diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090924 NDA NDA020401 Cardinal Health DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-4606_510e9cc4-0529-4c28-b6e6-180e2e47d17d 55154-4606 HUMAN PRESCRIPTION DRUG Tiazac Extended Release diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090924 NDA NDA020401 Cardinal Health DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-4607_510e9cc4-0529-4c28-b6e6-180e2e47d17d 55154-4607 HUMAN PRESCRIPTION DRUG Tiazac Extended Release diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090924 NDA NDA020401 Cardinal Health DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-4608_510e9cc4-0529-4c28-b6e6-180e2e47d17d 55154-4608 HUMAN PRESCRIPTION DRUG Tiazac Extended Release diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090924 NDA NDA020401 Cardinal Health DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-4609_510e9cc4-0529-4c28-b6e6-180e2e47d17d 55154-4609 HUMAN PRESCRIPTION DRUG Tiazac Extended Release diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090924 NDA NDA020401 Cardinal Health DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-4614_38ca3165-cd85-40b0-bf2e-57110585332e 55154-4614 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Cardinal Health ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-4615_06f2d964-a9fb-40ce-8206-304765d78e21 55154-4615 HUMAN PRESCRIPTION DRUG Namenda Memantine Hydrochloride TABLET ORAL 20031016 NDA NDA021487 Cardinal Health MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 55154-4616_38ca3165-cd85-40b0-bf2e-57110585332e 55154-4616 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Cardinal Health ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-4617_1e3c74c9-0017-4d7a-a716-2b5366286a67 55154-4617 HUMAN PRESCRIPTION DRUG Namenda Memantine Hydrochloride TABLET ORAL 20031016 NDA NDA021487 Cardinal Health MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 55154-4618_1e3c74c9-0017-4d7a-a716-2b5366286a67 55154-4618 HUMAN PRESCRIPTION DRUG Namenda Memantine Hydrochloride TABLET ORAL 20031016 NDA NDA021487 Cardinal Health MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 55154-4619_02194826-72a8-4436-9ade-e36fa5bb99da 55154-4619 HUMAN PRESCRIPTION DRUG Lexapro Escitalopram oxalate TABLET ORAL 20020814 NDA NDA021323 Cardinal Health ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-4620_02194826-72a8-4436-9ade-e36fa5bb99da 55154-4620 HUMAN PRESCRIPTION DRUG Lexapro Escitalopram oxalate TABLET ORAL 20020814 NDA NDA021323 Cardinal Health ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-4621_2d4ea551-cb8a-4453-98a3-601d89b1602a 55154-4621 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20080122 NDA NDA021742 Cardinal Health NEBIVOLOL HYDROCHLORIDE 5 mg/1 55154-4622_2d4ea551-cb8a-4453-98a3-601d89b1602a 55154-4622 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20080122 NDA NDA021742 Cardinal Health NEBIVOLOL HYDROCHLORIDE 20 mg/1 55154-4623_2d4ea551-cb8a-4453-98a3-601d89b1602a 55154-4623 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20080122 NDA NDA021742 Cardinal Health NEBIVOLOL HYDROCHLORIDE 10 mg/1 55154-4624_bfef9e19-d0f5-40fa-954c-b73c812eb242 55154-4624 HUMAN PRESCRIPTION DRUG VIIBRYD vilazodone hydrochloride TABLET ORAL 20110429 NDA NDA022567 Cardinal Health VILAZODONE HYDROCHLORIDE 40 mg/1 55154-4650_17b69d90-d955-4403-84e5-1465379d961c 55154-4650 HUMAN PRESCRIPTION DRUG Vancocin vancomycin hydrochloride CAPSULE ORAL 19860415 NDA NDA050606 Cardinal Health VANCOMYCIN HYDROCHLORIDE 125 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 55154-4651_17b69d90-d955-4403-84e5-1465379d961c 55154-4651 HUMAN PRESCRIPTION DRUG Vancocin vancomycin hydrochloride CAPSULE ORAL 19860415 NDA NDA050606 Cardinal Health VANCOMYCIN HYDROCHLORIDE 250 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 55154-4706_73c25835-d9e9-4051-b1b9-3d140effa3fd 55154-4706 HUMAN PRESCRIPTION DRUG MS CONTIN morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870701 NDA NDA019516 Cardinal Health MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55154-4707_73c25835-d9e9-4051-b1b9-3d140effa3fd 55154-4707 HUMAN PRESCRIPTION DRUG MS CONTIN morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870701 NDA NDA019516 Cardinal Health MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55154-4708_73c25835-d9e9-4051-b1b9-3d140effa3fd 55154-4708 HUMAN PRESCRIPTION DRUG MS CONTIN morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870701 NDA NDA019516 Cardinal Health MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55154-4709_30d327de-2971-4223-8429-f193fe5cc0fd 55154-4709 HUMAN OTC DRUG Colace docusate sodium CAPSULE ORAL 20110607 UNAPPROVED DRUG OTHER Cardinal Health DOCUSATE SODIUM 50 mg/1 55154-4725_c589f8f5-41f1-451a-8c3c-5f67d0981612 55154-4725 HUMAN PRESCRIPTION DRUG Bumetanide BUMETANIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20111116 ANDA ANDA074332 Cardinal Health BUMETANIDE .25 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-4726_fdc6ebcf-2b02-40be-8f68-fc50f87f2e37 55154-4726 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 19980706 ANDA ANDA075160 Cardinal Health METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-4727_64d55e06-4575-40b8-8b31-c8d967a4f484 55154-4727 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100713 NDA AUTHORIZED GENERIC NDA018667 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-4728_ab1df026-2346-4306-9099-3b495a365771 55154-4728 HUMAN PRESCRIPTION DRUG Bumetanide BUMETANIDE INJECTION, SOLUTION INTRANODAL; INTRAVENOUS 20111116 ANDA ANDA074332 Cardinal Health BUMETANIDE .25 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-4729_7db5c78c-0463-4ec9-b237-33f13e2f6460 55154-4729 HUMAN PRESCRIPTION DRUG Isuprel ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20120618 NDA NDA010515 Cardinal Health ISOPROTERENOL HYDROCHLORIDE .2 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 55154-4730_3af403b8-7bbb-4350-afde-9ff5bf0a5b90 55154-4730 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION RETROBULBAR; TOPICAL 20100324 ANDA ANDA088295 Cardinal Health LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-4731_b1089917-f63a-4031-a43a-e8c0b87c2849 55154-4731 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077548 Cardinal Health ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-4732_645a149e-9f57-4bc0-9ea2-b5fc72bd1c5d 55154-4732 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110708 ANDA ANDA070256 Cardinal Health NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 55154-4733_77db4f70-362e-4d65-a4a0-841a71954517 55154-4733 HUMAN PRESCRIPTION DRUG Bumetanide BUMETANIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20111116 ANDA ANDA074332 Cardinal Health BUMETANIDE .25 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-4734_3e25ee1f-01d6-4651-9b1c-b2b69bf51e8c 55154-4734 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020722 ANDA ANDA075857 Cardinal Health MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-4735_72b6a8ee-2aca-4fd3-84a5-81308309c8a3 55154-4735 HUMAN PRESCRIPTION DRUG DOPamine Hydrochloride Dopamine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19810519 NDA NDA018132 Cardinal Health DOPAMINE HYDROCHLORIDE 40 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-4736_2b82d876-3c8d-43ed-b25c-004e84d6fbd0 55154-4736 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 20100107 ANDA ANDA070584 Cardinal Health BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 55154-4737_d37d6c0a-f46a-49f3-b4eb-88df55ac22dc 55154-4737 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 19840127 UNAPPROVED DRUG OTHER Cardinal Health SODIUM BICARBONATE 42 mg/mL 55154-4738_b61ee9b5-da0d-4b12-95ad-a7202ae088be 55154-4738 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 19850501 UNAPPROVED DRUG OTHER Cardinal Health SODIUM BICARBONATE 84 mg/mL 55154-4739_3e5bb157-a56b-4c0d-8328-f2dc4f34a545 55154-4739 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110325 ANDA ANDA075136 Cardinal Health VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-4740_a70a9886-743e-487c-883a-aaeebb62e0e8 55154-4740 HUMAN PRESCRIPTION DRUG Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19860212 ANDA ANDA089070 Cardinal Health PROCAINAMIDE HYDROCHLORIDE 500 mg/mL Antiarrhythmic [EPC] 55154-4741_96727f19-5b45-4bd5-a473-3a54f9cdbcbc 55154-4741 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 20110318 NDA NDA016367 Cardinal Health DEXTROSE MONOHYDRATE 5 g/100mL 55154-4743_cbedf0bf-82a4-4214-96d5-01ac35e101f0 55154-4743 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020722 ANDA ANDA075857 Cardinal Health MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-4744_b79a4b53-0b1b-4f39-b58c-e7d1d0358f83 55154-4744 HUMAN PRESCRIPTION DRUG Meropenem MEROPENEM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100623 ANDA ANDA090940 Cardinal Health MEROPENEM 500 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 55154-4745_a670d75a-ec69-4570-a3be-c57b896fc553 55154-4745 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate METOPROLOL TARTRATE INJECTION, SOLUTION INTRAVENOUS 20080429 ANDA ANDA078085 Cardinal Health METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-4746_fd683410-ed74-4309-bebb-acf9bdcfe336 55154-4746 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride and Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 19880616 ANDA ANDA071165 Cardinal Health BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-4747_1b96ddc9-d0c3-488a-a113-66491fd3d899 55154-4747 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19991129 ANDA ANDA075239 Cardinal Health LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-4748_d26bdaf9-3215-48c6-92e1-5b7cabe9659a 55154-4748 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride and Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 19880616 ANDA ANDA071165 Cardinal Health BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-4749_13c11a5f-5651-47f1-a55c-e7f69280d683 55154-4749 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20090831 ANDA ANDA090571 Cardinal Health HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 55154-4750_3867e879-19d4-4e61-8d19-7677ad3188b2 55154-4750 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090311 ANDA ANDA018832 Cardinal Health ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 55154-4752_1e1e53cc-cca1-48e1-afb7-c5529eb744f9 55154-4752 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20100609 ANDA ANDA076704 Cardinal Health METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-4753_e8f18883-72aa-4b54-a9f6-512f3bfef570 55154-4753 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20110519 ANDA ANDA077584 Cardinal Health PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-4754_972659d8-e733-472c-9ca5-c45e2beb6d94 55154-4754 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120102 NDA AUTHORIZED GENERIC NDA020702 Cardinal Health ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-4755_972659d8-e733-472c-9ca5-c45e2beb6d94 55154-4755 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120116 NDA AUTHORIZED GENERIC NDA020702 Cardinal Health ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-4756_ecba926d-1ab6-4267-974f-bcea2f712043 55154-4756 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090105 ANDA ANDA077285 Cardinal Health BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 55154-4757_51f30f08-ab0d-496c-ac20-df3cfac6a24d 55154-4757 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20110701 ANDA ANDA077002 Cardinal Health DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 55154-4758_51f30f08-ab0d-496c-ac20-df3cfac6a24d 55154-4758 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20110701 ANDA ANDA077002 Cardinal Health DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 55154-4759_df3fb189-48ea-43bf-b4c6-aafc0f09513c 55154-4759 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM CAPSULE, COATED PELLETS ORAL 20090401 ANDA ANDA078919 Cardinal Health DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-4760_8e4472fa-1cbe-45c5-b82e-e3c4ea2de140 55154-4760 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM EXTENDED-RELEASE DIVALPROEX SODIUM EXTENDED-RELEASE TABLET, EXTENDED RELEASE ORAL 20091014 ANDA ANDA078705 Cardinal Health DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-4761_b2a3c16b-cf37-42c1-bf20-2e679767a2ab 55154-4761 HUMAN PRESCRIPTION DRUG Divalproex Sodium DR Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20091014 ANDA ANDA078790 Cardinal Health DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-4762_cc396a59-0313-4cad-8e08-3fd85291df30 55154-4762 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Cardinal Health QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 55154-4763_cc396a59-0313-4cad-8e08-3fd85291df30 55154-4763 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Cardinal Health QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 55154-4764_cc396a59-0313-4cad-8e08-3fd85291df30 55154-4764 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Cardinal Health QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 55154-4765_cc396a59-0313-4cad-8e08-3fd85291df30 55154-4765 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Cardinal Health QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 55154-4767_940c1e94-4a6b-477a-94f4-e5f94131532f 55154-4767 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078865 Cardinal Health VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-4768_940c1e94-4a6b-477a-94f4-e5f94131532f 55154-4768 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078865 Cardinal Health VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-4769_940c1e94-4a6b-477a-94f4-e5f94131532f 55154-4769 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078865 Cardinal Health VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-4770_a1205cde-9534-43a9-914e-ac4e75a78b0d 55154-4770 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20130702 ANDA ANDA077560 Cardinal Health ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 55154-4772_a2dba360-51f1-4970-9ff1-5e30cc1b313d 55154-4772 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20120831 ANDA ANDA075694 Cardinal Health GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-4774_1dece64d-34bb-4da6-bb5d-84c294184998 55154-4774 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20110519 ANDA ANDA073554 Cardinal Health NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 55154-4775_b6a05166-43cf-4768-a918-95e3b72edaca 55154-4775 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20060908 ANDA ANDA040596 Cardinal Health PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-4776_2a850feb-e26f-4cb5-8653-336bd15f8bfc 55154-4776 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20120305 ANDA ANDA075350 Cardinal Health GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-4777_33ae00b9-bd60-46ac-ba03-f0d8a6998712 55154-4777 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 20070730 ANDA ANDA071826 Cardinal Health MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-4778_c185561b-8a18-412e-9bfb-50d2c6f11de4 55154-4778 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100813 ANDA ANDA090615 Cardinal Health METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-4779_aafcc03e-b7d2-483a-8ace-4ff27cb768b3 55154-4779 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20130717 ANDA ANDA090509 Cardinal Health TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 55154-4780_06b4cfbb-9ccd-4c2b-8432-2f6aaf55f933 55154-4780 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20120402 ANDA ANDA040412 Cardinal Health HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55154-4781_9e5c3d88-800d-41e3-80b0-520826e9572b 55154-4781 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20110502 ANDA ANDA078103 Cardinal Health SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-4782_9e5c3d88-800d-41e3-80b0-520826e9572b 55154-4782 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20110502 ANDA ANDA078103 Cardinal Health SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-4783_8b08401f-fc1b-4e9e-9962-598a8e0f37be 55154-4783 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101014 ANDA ANDA078243 Cardinal Health LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-4784_6f657360-b660-4c4b-94eb-d38649b4bdc1 55154-4784 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20130524 ANDA ANDA077751 Cardinal Health PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-4785_e1d58865-3584-4e1d-9540-d2cd3ddf8082 55154-4785 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130215 ANDA ANDA075155 Cardinal Health ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 55154-4786_e1d58865-3584-4e1d-9540-d2cd3ddf8082 55154-4786 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130215 ANDA ANDA075155 Cardinal Health ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 55154-4787_2139e097-c7a4-4f9a-ab7f-cd2d007af37f 55154-4787 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20121211 ANDA ANDA074984 Cardinal Health DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-4788_2139e097-c7a4-4f9a-ab7f-cd2d007af37f 55154-4788 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20121212 ANDA ANDA074984 Cardinal Health DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-4789_98bef8a2-bf49-4756-bc31-18d9796151c5 55154-4789 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED ORAL 20121129 ANDA ANDA090216 Cardinal Health VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55154-4790_1e1e53cc-cca1-48e1-afb7-c5529eb744f9 55154-4790 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130723 ANDA ANDA077739 Cardinal Health METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-4791_a757af22-6fcb-499c-a77f-007a04382d67 55154-4791 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20100323 ANDA ANDA076003 Cardinal Health TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 55154-4792_a4ffb53f-7935-4ddc-844e-0112ae6cb5d4 55154-4792 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20120305 ANDA ANDA075350 Cardinal Health GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-4793_407420f4-bdef-4d76-bb56-9a55daff6ae7 55154-4793 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20110501 ANDA ANDA078920 Cardinal Health PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55154-4794_37d1c722-1e8f-48b7-a42b-d8175e990f50 55154-4794 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20130523 ANDA ANDA201294 Cardinal Health MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 55154-4795_8a36a6ef-5893-4da8-ad92-495bc772f247 55154-4795 HUMAN PRESCRIPTION DRUG FAMOTIDINE FAMOTIDINE TABLET ORAL 20130705 ANDA ANDA090837 Cardinal Health FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55154-4796_2e1625cd-7337-4eed-95b1-b371c7169b97 55154-4796 HUMAN PRESCRIPTION DRUG Nephrocaps Ascorbic Acid, Folic Acid, Niacin, Thiamine, Riboflavin, Pyridoxine, Cyanocobalamin, Pantothenic Acid, Biotin CAPSULE, LIQUID FILLED ORAL 20100114 UNAPPROVED DRUG OTHER Cardinal Health ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; THIAMINE 100; 150; 6; 1; 20; 5; 10; 1.7; 1.5 mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 55154-4797_cf77a165-c2f6-48a3-be97-cd19ccdbd036 55154-4797 HUMAN PRESCRIPTION DRUG GEMFIBROZIL GEMFIBROZIL TABLET, FILM COATED ORAL 20110601 ANDA ANDA074256 Cardinal Health GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 55154-4798_275a8e6f-2cbf-46c3-96d7-9204da74b493 55154-4798 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20050922 ANDA ANDA078402 Cardinal Health LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-4799_2139e097-c7a4-4f9a-ab7f-cd2d007af37f 55154-4799 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20121211 ANDA ANDA074984 Cardinal Health DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-4837_fbc6dc5a-5640-4e28-bc71-1f507ecc8edd 55154-4837 HUMAN PRESCRIPTION DRUG Nifedical XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20001211 ANDA ANDA075289 Cardinal Health NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-4838_7d46690d-090d-4d8b-af63-e57c48fc86b5 55154-4838 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 Cardinal Health SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-4839_72565ea4-0d7c-4e9e-843f-5ca89eafd4f7 55154-4839 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20001020 ANDA ANDA075536 Cardinal Health DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55154-4840_72565ea4-0d7c-4e9e-843f-5ca89eafd4f7 55154-4840 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20001020 ANDA ANDA075536 Cardinal Health DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55154-4842_41dd56bd-8c74-4fd7-9f1e-3f7154f9df70 55154-4842 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19900930 ANDA ANDA088628 Cardinal Health ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 55154-4843_64106454-0c53-4bef-b829-47a4b2a7a09e 55154-4843 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Cardinal Health DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-4844_64106454-0c53-4bef-b829-47a4b2a7a09e 55154-4844 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Cardinal Health DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-4845_3411162a-d371-4162-b774-454759fae299 55154-4845 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19930701 ANDA ANDA072801 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 55154-4846_bb77d8a1-7c32-4f85-bdd2-a0093ec73e05 55154-4846 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Cardinal Health FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-4853_2247e68f-60ba-42fc-b617-2fc2843994a5 55154-4853 HUMAN OTC DRUG Aleve naproxen sodium TABLET ORAL 19940111 NDA NDA020204 Cardinal Health NAPROXEN SODIUM 220 mg/1 55154-4875_f08fa2ee-70fd-4aff-a737-605bcb771f7b 55154-4875 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20040404 NDA NDA021688 Cardinal Health CINACALCET HYDROCHLORIDE 30 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] 55154-4876_f08fa2ee-70fd-4aff-a737-605bcb771f7b 55154-4876 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20040404 NDA NDA021688 Cardinal Health CINACALCET HYDROCHLORIDE 60 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] 55154-4901_8f86687b-80c2-4552-9f6e-9055852e7aaa 55154-4901 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20110629 ANDA ANDA084612 Cardinal Health DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-4906_c04a6eb9-2e77-446a-bc24-1aeee060ed39 55154-4906 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 ANDA ANDA018823 Cardinal Health FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-4908_c04a6eb9-2e77-446a-bc24-1aeee060ed39 55154-4908 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 ANDA ANDA018823 Cardinal Health FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-4909_c04a6eb9-2e77-446a-bc24-1aeee060ed39 55154-4909 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19860124 ANDA ANDA070086 Cardinal Health FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-4914_8f86687b-80c2-4552-9f6e-9055852e7aaa 55154-4914 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20110629 ANDA ANDA087916 Cardinal Health DEXAMETHASONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-4915_c04a6eb9-2e77-446a-bc24-1aeee060ed39 55154-4915 HUMAN PRESCRIPTION DRUG Furosemide Furosemide SOLUTION ORAL 19870422 ANDA ANDA070433 Cardinal Health FUROSEMIDE 40 mg/5mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-4920_83cc6d36-7e45-4608-a4aa-3c9d4007506a 55154-4920 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19870728 NDA NDA017812 Cardinal Health LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 55154-4921_a31077bd-4dc4-4f75-b9d1-8b85bda1a463 55154-4921 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 19960216 ANDA ANDA074069 Cardinal Health AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 55154-4926_2b3a546b-1bb1-407f-9871-27c7d7d596c1 55154-4926 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087800 Cardinal Health PREDNISONE 1 mg/1 55154-4938_2b3a546b-1bb1-407f-9871-27c7d7d596c1 55154-4938 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 Cardinal Health PREDNISONE 5 mg/1 55154-4941_83cc6d36-7e45-4608-a4aa-3c9d4007506a 55154-4941 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET ORAL 19820129 ANDA ANDA018558 Cardinal Health LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 55154-4944_6009ceb6-032d-45af-95b6-de969a196bcf 55154-4944 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride SOLUTION ORAL 19920430 ANDA ANDA073079 Cardinal Health LOPERAMIDE HYDROCHLORIDE 2 mg/10mL Opioid Agonist [EPC],Opioid Agonists [MoA] 55154-4945_664beea2-fc7f-4748-801b-9cb398604976 55154-4945 HUMAN PRESCRIPTION DRUG Lidocaine Viscous Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19850426 ANDA ANDA088802 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-4946_2b3a546b-1bb1-407f-9871-27c7d7d596c1 55154-4946 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA087342 Cardinal Health PREDNISONE 20 mg/1 55154-4949_2b3a546b-1bb1-407f-9871-27c7d7d596c1 55154-4949 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA084122 Cardinal Health PREDNISONE 10 mg/1 55154-4950_2b3a546b-1bb1-407f-9871-27c7d7d596c1 55154-4950 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030314 ANDA ANDA084283 Cardinal Health PREDNISONE 50 mg/1 55154-4951_9b993954-cddd-48cd-a7b2-302918118a1a 55154-4951 HUMAN PRESCRIPTION DRUG Clotrimazole Clotrimazole LOZENGE ORAL; TOPICAL 20040729 ANDA ANDA076387 Cardinal Health CLOTRIMAZOLE 10 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 55154-4952_83cc6d36-7e45-4608-a4aa-3c9d4007506a 55154-4952 HUMAN PRESCRIPTION DRUG Lithium Lithium Carbonate SOLUTION ORAL 19820429 NDA NDA018421 Cardinal Health LITHIUM CARBONATE 8 meq/5mL Mood Stabilizer [EPC] 55154-4953_49212741-389f-4112-94a9-d14ea2115825 55154-4953 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 19960216 ANDA ANDA074069 Cardinal Health AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 55154-4954_2b3a546b-1bb1-407f-9871-27c7d7d596c1 55154-4954 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 Cardinal Health PREDNISONE 5 mg/1 55154-4956_cb84357f-c455-4cb1-a9a2-edaa3ef20a68 55154-4956 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 Cardinal Health RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-4957_cb84357f-c455-4cb1-a9a2-edaa3ef20a68 55154-4957 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 Cardinal Health RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-4958_33c85ceb-dea8-4e03-be16-c577d2ff03e6 55154-4958 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20071009 ANDA ANDA077795 Cardinal Health OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-4959_33c85ceb-dea8-4e03-be16-c577d2ff03e6 55154-4959 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20071009 ANDA ANDA077795 Cardinal Health OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-4960_5b86819d-7b23-441e-aeef-9dea870108bf 55154-4960 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20041028 ANDA ANDA076832 Cardinal Health LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 55154-4961_06ac3f43-d861-46db-84f7-10fab4eb8cda 55154-4961 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20080226 ANDA ANDA077728 Cardinal Health CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 55154-4962_439c0016-5ab6-4a94-b4e3-2c852bf295d9 55154-4962 HUMAN PRESCRIPTION DRUG Buprenorphine HCl Buprenorphine HCl TABLET SUBLINGUAL 20091008 ANDA ANDA078633 Cardinal Health BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 55154-4965_45fbf894-051b-4543-830f-ea79df228a06 55154-4965 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA084122 Cardinal Health PREDNISONE 10 mg/1 55154-4975_1444648c-2a2b-464e-9941-b0867a5ce305 55154-4975 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20130612 ANDA ANDA087479 Cardinal Health HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 55154-4976_17a8b7c0-4cda-485d-b093-953dbe2aefe4 55154-4976 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20130614 UNAPPROVED DRUG OTHER Cardinal Health LORATADINE 10 mg/1 55154-4978_d454e140-1db5-4c1e-9cb6-449303c542b0 55154-4978 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131223 ANDA ANDA077321 Cardinal Health LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-4979_b26dcb53-677b-4da1-b8bb-c30a6ed49da3 55154-4979 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20130904 ANDA ANDA074112 Cardinal Health ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-4980_3ac3cf3c-6590-44c2-8689-7ef691cfe2b3 55154-4980 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131223 ANDA ANDA090694 Cardinal Health DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-4981_3ac3cf3c-6590-44c2-8689-7ef691cfe2b3 55154-4981 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131223 ANDA ANDA090694 Cardinal Health DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-4982_6f657360-b660-4c4b-94eb-d38649b4bdc1 55154-4982 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20130524 ANDA ANDA077751 Cardinal Health PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-4984_d2ddd7e2-7a5b-4630-8246-064fdcc69d6e 55154-4984 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20130726 ANDA ANDA077728 Cardinal Health CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 55154-4985_fb2e6030-c1f4-44bb-9279-3c7368785009 55154-4985 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140203 ANDA ANDA077955 Cardinal Health AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-4986_02be47ad-999f-4565-b9a9-21f447314140 55154-4986 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20140217 ANDA ANDA065507 Cardinal Health AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55154-4987_aebafb64-ce8f-4d3e-8a6a-e4e4e2a6ddfc 55154-4987 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140306 ANDA ANDA090617 Cardinal Health METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-4988_1d19ba61-10d9-4839-80db-74a9712c8601 55154-4988 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20130626 ANDA ANDA076899 Cardinal Health SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 55154-4989_0b089981-74b3-45bb-a9c8-848c9d0d4b53 55154-4989 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20100511 ANDA ANDA076514 Cardinal Health MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 55154-4990_b560bfd6-fbee-4cc2-907f-7ee17c66aaca 55154-4990 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine Phosphate acetaminophen and codeine phosphate TABLET ORAL 20100113 ANDA ANDA089805 Cardinal Health ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 55154-4991_8f59b47f-c762-42f2-9700-89d5618154bb 55154-4991 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20080703 ANDA ANDA077614 Cardinal Health CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55154-4993_aebafb64-ce8f-4d3e-8a6a-e4e4e2a6ddfc 55154-4993 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140306 ANDA ANDA090617 Cardinal Health METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-5009_8e86920e-1432-4eee-aff4-6736c217a829 55154-5009 HUMAN PRESCRIPTION DRUG COZAAR losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Cardinal Health LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-5016_8e86920e-1432-4eee-aff4-6736c217a829 55154-5016 HUMAN PRESCRIPTION DRUG COZAAR losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Cardinal Health LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-5019_ebcb1bef-463a-4503-b847-68d45d0aced6 55154-5019 HUMAN PRESCRIPTION DRUG PRIMAXIN IV imipenem and cilastatin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19870108 ANDA ANDA062756 Cardinal Health CILASTATIN SODIUM; IMIPENEM 500; 500 mg/100mL; mg/100mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 55154-5026_e3fee196-eae5-45f2-97ec-09141481d562 55154-5026 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20100510 NDA NDA019962 Cardinal Health METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-5028_6943beeb-03aa-48c8-8a18-0cee9dc46f28 55154-5028 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, FILM COATED ORAL 19980220 NDA NDA020829 Cardinal Health MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 55154-5029_6943beeb-03aa-48c8-8a18-0cee9dc46f28 55154-5029 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 19980220 NDA NDA020830 Cardinal Health MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 55154-5030_ebcb1bef-463a-4503-b847-68d45d0aced6 55154-5030 HUMAN PRESCRIPTION DRUG PRIMAXIN IV imipenem and cilastatin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19851126 NDA NDA050587 Cardinal Health CILASTATIN SODIUM; IMIPENEM 500; 500 mg/100mL; mg/100mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 55154-5031_a7150fc3-a2bd-40bf-bb50-6bcb86359564 55154-5031 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20110729 NDA NDA021445 Cardinal Health EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] 55154-5033_d487533f-c1f6-48a9-94fb-48f6fbad7ca4 55154-5033 HUMAN PRESCRIPTION DRUG Mephyton phytonadione TABLET ORAL 19550930 NDA NDA010104 Cardinal Health PHYTONADIONE 5 mg/1 Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 55154-5034_167e3ec5-c0ee-4943-9959-158efc0157d5 55154-5034 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20090727 NDA NDA021445 Cardinal Health EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] 55154-5035_0c50fec9-6a32-49a9-870f-adbbcac6816c 55154-5035 HUMAN OTC DRUG MiraLAX Polyethylene Glycol 3350 POWDER ORAL 20090223 NDA NDA022015 Cardinal Health POLYETHYLENE GLYCOL 3350 17 g/17g 55154-5037_e6152390-85e7-4055-adad-370efd086015 55154-5037 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20061016 NDA NDA021995 Cardinal Health SITAGLIPTIN PHOSPHATE 50 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 55154-5038_e6152390-85e7-4055-adad-370efd086015 55154-5038 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20061016 NDA NDA021995 Cardinal Health SITAGLIPTIN PHOSPHATE 100 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 55154-5040_98889358-9861-424e-8e0e-0a0749ab9a4b 55154-5040 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20061016 NDA NDA021995 Cardinal Health SITAGLIPTIN PHOSPHATE 50 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 55154-5041_98889358-9861-424e-8e0e-0a0749ab9a4b 55154-5041 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20061016 NDA NDA021995 Cardinal Health SITAGLIPTIN PHOSPHATE 100 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 55154-5042_7d6ad334-57f9-4ffc-bab2-7d6da8be0c4d 55154-5042 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20061016 NDA NDA021995 Cardinal Health SITAGLIPTIN PHOSPHATE 100 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 55154-5051_fe972c56-1584-4a72-b4ad-39935d8771ae 55154-5051 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20120827 ANDA ANDA076071 Cardinal Health LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-5052_fe972c56-1584-4a72-b4ad-39935d8771ae 55154-5052 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20120827 ANDA ANDA076071 Cardinal Health LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-5053_fe972c56-1584-4a72-b4ad-39935d8771ae 55154-5053 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20120827 ANDA ANDA076071 Cardinal Health LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-5055_93a5ee92-d832-484e-b80b-4b43bef5c67e 55154-5055 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20110204 ANDA ANDA040424 Cardinal Health SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 55154-5056_5efa81d1-5168-457c-b5e5-b0080b938ebb 55154-5056 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20110620 ANDA ANDA073457 Cardinal Health ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-5057_e5b78cf7-675c-49fc-8f1b-1e9c6c01ea36 55154-5057 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20100114 ANDA ANDA076110 Cardinal Health TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-5062_612a5628-d2d3-48bf-820c-1e80c5a7fd62 55154-5062 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130404 ANDA ANDA076052 Cardinal Health SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-5063_612a5628-d2d3-48bf-820c-1e80c5a7fd62 55154-5063 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130404 ANDA ANDA076052 Cardinal Health SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-5065_93a5ee92-d832-484e-b80b-4b43bef5c67e 55154-5065 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20110204 ANDA ANDA040424 Cardinal Health SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 55154-5066_e50f9fe8-95a8-478b-ba4b-211715e10694 55154-5066 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 20110617 ANDA ANDA086009 Cardinal Health AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 55154-5067_bed243c3-9497-45af-9fd7-2cafc25ccc96 55154-5067 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20110818 ANDA ANDA071017 Cardinal Health SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 55154-5068_64d72549-f5ce-4537-8249-b0b704f8b708 55154-5068 HUMAN PRESCRIPTION DRUG Tizanidine tizanidine TABLET ORAL 20110128 ANDA ANDA076354 Cardinal Health TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55154-5070_7a467a52-5ef0-4e25-bee6-fad64182a863 55154-5070 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20101104 ANDA ANDA077624 Cardinal Health GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55154-5071_b0cafa5c-8643-414d-a14b-e8b369ae8033 55154-5071 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20100806 ANDA ANDA075189 Cardinal Health NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-5072_8ec48613-5892-4ec0-801b-3429c8eae185 55154-5072 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100114 ANDA ANDA076418 Cardinal Health AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-5073_1b67797e-c04a-483f-ad72-7fc15e3abbfa 55154-5073 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20110920 ANDA ANDA070213 Cardinal Health PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-5074_1984bbf4-e376-44ce-b640-c1a163bbc889 55154-5074 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20091120 ANDA ANDA070325 Cardinal Health DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5079_4bd9895d-9a12-40d7-b61c-95b948e6e0b8 55154-5079 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET ORAL 20110128 ANDA ANDA076578 Cardinal Health ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55154-5080_4bd9895d-9a12-40d7-b61c-95b948e6e0b8 55154-5080 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET ORAL 20110128 ANDA ANDA076578 Cardinal Health ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55154-5082_fe972c56-1584-4a72-b4ad-39935d8771ae 55154-5082 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20120827 ANDA ANDA076071 Cardinal Health LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-5085_2d4a80d9-cf88-4173-a42e-013bf8633257 55154-5085 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20110513 ANDA ANDA088468 Cardinal Health HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-5086_8e9e18aa-6c9d-4172-87b4-4bec6f485cb9 55154-5086 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, CHEWABLE ORAL 20111028 ANDA ANDA073524 Cardinal Health CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 55154-5087_78019675-b522-4a60-9474-5f075e96171b 55154-5087 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20110114 ANDA ANDA078902 Cardinal Health PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-5088_103fc54c-3102-4068-b7c8-bd68c791c001 55154-5088 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20110401 ANDA ANDA084768 Cardinal Health CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5089_103fc54c-3102-4068-b7c8-bd68c791c001 55154-5089 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20110401 ANDA ANDA083116 Cardinal Health CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5090_f16f87c3-bcf1-4daf-892c-d5104819a6bc 55154-5090 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20110204 ANDA ANDA070920 Cardinal Health TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5091_3a3afdf7-59dd-45e8-8f3c-b0001eff37b7 55154-5091 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110711 ANDA ANDA075124 Cardinal Health DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-5092_db094fd7-6b3d-44ad-b76d-67ee137d0661 55154-5092 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20110803 ANDA ANDA088487 Cardinal Health HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 55154-5093_2a911dc9-a0fa-4efa-8d09-b300038cce28 55154-5093 HUMAN PRESCRIPTION DRUG Methyldopa methyldopa TABLET ORAL 20110823 ANDA ANDA070076 Cardinal Health METHYLDOPA 250 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55154-5094_f51fc098-1e7c-4f9d-b05e-dc029ed14ae7 55154-5094 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20110128 ANDA ANDA040185 Cardinal Health PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-5095_562ed0bc-02f3-44ea-a8a1-ca127ebbf188 55154-5095 HUMAN PRESCRIPTION DRUG PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET, FILM COATED ORAL 20110520 ANDA ANDA075998 Cardinal Health PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] 55154-5096_810e9adf-2cfe-4c28-9e9d-6df7c29e78d4 55154-5096 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20091016 ANDA ANDA040742 Cardinal Health BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 55154-5097_8ec48613-5892-4ec0-801b-3429c8eae185 55154-5097 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100114 ANDA ANDA076418 Cardinal Health AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-5098_704f5fdf-ee30-4626-a306-28ee4b98fc64 55154-5098 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20110712 ANDA ANDA090062 Cardinal Health DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-5099_2d44179c-2f4f-4f84-aeb7-3521f6b2c7cc 55154-5099 HUMAN OTC DRUG Loratadine loratadine TABLET ORAL 20091119 ANDA ANDA075790 Cardinal Health LORATADINE 10 mg/1 55154-5102_93083e30-1e00-4b0b-97da-daf6014d5885 55154-5102 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20110628 ANDA ANDA080817 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 55154-5106_2acd0b79-94f9-4934-aabe-24e8d7800d5b 55154-5106 HUMAN PRESCRIPTION DRUG Digoxin Digoxin INJECTION INTRAMUSCULAR; INTRAVENOUS 20110628 ANDA ANDA083391 Cardinal Health DIGOXIN .25 mg/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 55154-5112_0ba1563f-764c-422d-b1cb-1755483b7084 55154-5112 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 Cardinal Health PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-5117_5ef18f1c-0e8c-427e-a783-e0fd0e3ea297 55154-5117 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19750716 ANDA ANDA084307 Cardinal Health PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-5118_cca4f601-b4f6-4484-a260-0fb43abd250a 55154-5118 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION INTRAMUSCULAR; INTRAVENOUS 19820907 ANDA ANDA087702 Cardinal Health DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-5127_8ab8b554-d2a3-43f7-8885-6bf6dd2c2a0c 55154-5127 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100126 ANDA ANDA083312 Cardinal Health PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-5128_7dfaac8d-ceab-4af0-9c44-bed73414789d 55154-5128 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20121220 NDA NDA203826 Cardinal Health PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 55154-5150_be0658c3-6b91-4b67-98c3-a580ef560bf8 55154-5150 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 19990715 NDA NDA021073 Cardinal Health PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 55154-5151_be0658c3-6b91-4b67-98c3-a580ef560bf8 55154-5151 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 19990715 NDA NDA021073 Cardinal Health PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 55154-5152_be0658c3-6b91-4b67-98c3-a580ef560bf8 55154-5152 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 19990715 NDA NDA021073 Cardinal Health PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 55154-5153_2d2473a3-093d-44e7-b6c2-f909e3740606 55154-5153 HUMAN PRESCRIPTION DRUG Actoplus Met pioglitazone hydrochloride and metformin hydrochloride TABLET, FILM COATED ORAL 20050829 NDA NDA021842 Cardinal Health METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 55154-5154_5b487e05-d784-46b8-9223-f2e48d2d7fc5 55154-5154 HUMAN PRESCRIPTION DRUG Dexilant dexlansoprazole CAPSULE, DELAYED RELEASE ORAL 20100412 NDA NDA022287 Cardinal Health DEXLANSOPRAZOLE 60 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55154-5157_847af9a9-57e3-4474-99ab-89cd0380f125 55154-5157 HUMAN PRESCRIPTION DRUG Colcrys Colchicine TABLET, FILM COATED ORAL 20090901 NDA NDA022352 Cardinal Health COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 55154-5175_f4236679-d8b0-4c9d-a392-41178d19455b 55154-5175 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE SOLUTION INTRAVENOUS 19830929 NDA NDA018900 Cardinal Health METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 55154-5177_f8cfc907-2b93-4f24-bf79-e2c11a72b83b 55154-5177 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride IRRIGANT IRRIGATION 20090914 NDA NDA016733 Cardinal Health SODIUM CHLORIDE .9 g/100mL 55154-5178_6d1c2560-f289-49a9-9471-71199492fd8e 55154-5178 HUMAN PRESCRIPTION DRUG HESPAN Hetastarch in Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19910404 NDA NDA890105 Cardinal Health HETASTARCH; SODIUM CHLORIDE 6; .9 g/100mL; g/100mL Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [Chemical/Ingredient] 55154-5224_d7795df3-be5f-4250-8ca5-b4e73826e57b 55154-5224 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20101104 ANDA ANDA074226 Cardinal Health GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55154-5254_b68a3ddb-b97f-4e9c-b22e-c444368e0b90 55154-5254 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20091201 ANDA ANDA078556 Cardinal Health DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 55154-5275_b08acae1-32a7-43a2-bc79-4777b8cb4fd2 55154-5275 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090721 ANDA ANDA079001 Cardinal Health VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 55154-5325_1d252550-f210-4982-a123-4b0e66c47259 55154-5325 HUMAN PRESCRIPTION DRUG Ofirmev acetaminophen INJECTION, SOLUTION INTRAVENOUS 20101108 NDA NDA022450 Cardinal Health ACETAMINOPHEN 10 mg/mL 55154-5350_74f37abc-005f-412f-9ce6-3c080c29cfd3 55154-5350 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 20110513 ANDA ANDA087128 Cardinal Health MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 55154-5351_727cad56-e4a2-48ec-83a7-15b7722f6dcf 55154-5351 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20110520 ANDA ANDA064150 Cardinal Health RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 55154-5352_82f1724d-ccf2-4034-96c7-1497320ff180 55154-5352 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 325 mg/1 55154-5353_e50f9fe8-95a8-478b-ba4b-211715e10694 55154-5353 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 20110617 ANDA ANDA086009 Cardinal Health AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 55154-5355_9e4c1c56-0a7e-45f9-9c0a-e976e3c3632b 55154-5355 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20091130 ANDA ANDA076122 Cardinal Health MIRTAZAPINE 15 mg/1 55154-5356_dce289ff-2e70-4d6c-9e35-29f06eb8581b 55154-5356 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20110114 ANDA ANDA076704 Cardinal Health METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-5357_4b05e996-c8c3-4d78-9e51-38e1056c0d24 55154-5357 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070620 ANDA ANDA019684 Cardinal Health NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-5358_4b05e996-c8c3-4d78-9e51-38e1056c0d24 55154-5358 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20071106 ANDA ANDA019684 Cardinal Health NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-5359_f0723e75-9bc6-455b-9688-cdb94dfe67e2 55154-5359 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20100507 ANDA ANDA090408 Cardinal Health TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55154-5360_bf85a378-6a09-4b35-b145-0624b1864241 55154-5360 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET ORAL 20091105 ANDA ANDA090324 Cardinal Health CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 55154-5361_dc5c6650-7ee8-4357-b037-08cd265b985a 55154-5361 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA073229 Cardinal Health VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-5362_d528bd13-4a7d-43be-b0a5-64ba92ee3d03 55154-5362 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20101029 ANDA ANDA076187 Cardinal Health LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-5363_cb6d8601-5663-412b-ae46-7dda81db3d84 55154-5363 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100623 ANDA ANDA090649 Cardinal Health NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-5364_b7e5f316-45af-48d5-b722-f2182459bf6b 55154-5364 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20101008 ANDA ANDA040245 Cardinal Health CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55154-5365_27766e4d-e689-4d54-aa08-1088faa6c3d4 55154-5365 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20120210 ANDA ANDA076056 Cardinal Health PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-5366_1a5ed33b-03fa-4b20-87c3-c4d52a7604a5 55154-5366 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride pramipexole dihydrochloride TABLET ORAL 20101117 ANDA ANDA077854 Cardinal Health PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55154-5367_8574acd5-ad13-424f-bdfe-152c6623b24c 55154-5367 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 20110812 ANDA ANDA091590 Cardinal Health LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-5368_cb6d8601-5663-412b-ae46-7dda81db3d84 55154-5368 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100623 ANDA ANDA090649 Cardinal Health NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-5369_d3628f05-bdbe-4530-a99b-ea4a23f86f83 55154-5369 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron TABLET, FILM COATED ORAL 20121205 ANDA ANDA076930 Cardinal Health ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-5370_27766e4d-e689-4d54-aa08-1088faa6c3d4 55154-5370 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20120210 ANDA ANDA076056 Cardinal Health PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-5371_68e043a5-e7de-4013-85ba-a2fa7bce624f 55154-5371 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20120105 ANDA ANDA076314 Cardinal Health TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-5372_68e043a5-e7de-4013-85ba-a2fa7bce624f 55154-5372 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20120105 ANDA ANDA076314 Cardinal Health TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-5373_fa6d08ab-8992-4fe9-bb83-0455662c793f 55154-5373 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111003 ANDA ANDA090868 Cardinal Health SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-5374_fa6d08ab-8992-4fe9-bb83-0455662c793f 55154-5374 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111003 ANDA ANDA090868 Cardinal Health SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-5375_b3b66cc3-263d-4e51-863c-8fda57cb016b 55154-5375 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20110520 ANDA ANDA040756 Cardinal Health FOLIC ACID 1 mg/1 55154-5376_3d08ead1-af44-4306-a959-c8b5e82130a8 55154-5376 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED ORAL 20120629 ANDA ANDA075817 Cardinal Health CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55154-5377_7c41aa69-0738-4ea5-a5ed-fc6efcb92f8c 55154-5377 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20100723 ANDA ANDA091176 Cardinal Health HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 55154-5378_fa6d08ab-8992-4fe9-bb83-0455662c793f 55154-5378 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111003 ANDA ANDA090868 Cardinal Health SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-5379_764b7eda-d1b8-4ae5-bc12-4036da810c32 55154-5379 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Cardinal Health ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-5380_d528bd13-4a7d-43be-b0a5-64ba92ee3d03 55154-5380 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20101029 ANDA ANDA076187 Cardinal Health LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-5381_d528bd13-4a7d-43be-b0a5-64ba92ee3d03 55154-5381 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20101029 ANDA ANDA076187 Cardinal Health LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-5382_ff007079-b14e-4462-bc20-577595805100 55154-5382 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil mycophenolate mofetil TABLET ORAL 20111025 ANDA ANDA065521 Cardinal Health MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 55154-5383_2b4519cf-21e9-4340-940d-65b59b327ac4 55154-5383 HUMAN OTC DRUG Polyethylene Glycol (3350) polyethylene glycol (3350) POWDER, FOR SOLUTION ORAL 20091120 ANDA ANDA078915 Cardinal Health POLYETHYLENE GLYCOL 3500 17 g/17g 55154-5384_bea3b4cc-2200-446b-9061-80e514f2dc4f 55154-5384 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20120925 ANDA ANDA078518 Cardinal Health VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55154-5385_d53c86a2-99ca-4e40-b61b-d3cce1ce0f7e 55154-5385 HUMAN PRESCRIPTION DRUG Voriconazole voriconazole TABLET, FILM COATED ORAL 20120921 ANDA ANDA090547 Cardinal Health VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55154-5386_764b7eda-d1b8-4ae5-bc12-4036da810c32 55154-5386 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Cardinal Health ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-5387_708c8da7-b32f-4823-b2f0-0eab01175399 55154-5387 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20120824 ANDA ANDA077420 Cardinal Health LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-5388_b4e53c96-e280-47c6-baa0-ec676e041d8d 55154-5388 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate clopidogrel TABLET, FILM COATED ORAL 20120608 ANDA ANDA077665 Cardinal Health CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 55154-5389_15e34372-d10b-4da3-860c-ca3430ac4c4f 55154-5389 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20110818 ANDA ANDA070791 Cardinal Health DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 55154-5390_83540d64-81ba-441b-922b-cf18cc12b13b 55154-5390 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 20110513 ANDA ANDA074621 Cardinal Health MEGESTROL ACETATE 20 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 55154-5391_8db24e9b-9659-468b-8774-42045d90d517 55154-5391 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20121011 ANDA ANDA070035 Cardinal Health METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 55154-5392_8db24e9b-9659-468b-8774-42045d90d517 55154-5392 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20121011 ANDA ANDA070044 Cardinal Health METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 55154-5393_dd3554ed-749b-4736-ab77-77966eb5c9f0 55154-5393 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20120919 ANDA ANDA072688 Cardinal Health RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 55154-5394_2d4a80d9-cf88-4173-a42e-013bf8633257 55154-5394 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20110513 ANDA ANDA089097 Cardinal Health HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-5395_d528bd13-4a7d-43be-b0a5-64ba92ee3d03 55154-5395 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20101029 ANDA ANDA076187 Cardinal Health LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-5396_708c8da7-b32f-4823-b2f0-0eab01175399 55154-5396 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20120824 ANDA ANDA077420 Cardinal Health LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-5397_2e3a4168-a459-423a-823c-e45cca3b886f 55154-5397 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20100331 ANDA ANDA075272 Cardinal Health BUSPIRONE HYDROCHLORIDE 10 mg/1 55154-5398_6912788d-9c81-4ce3-9da3-5175219d9e78 55154-5398 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20110107 ANDA ANDA077923 Cardinal Health MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-5399_a254dd93-c7b3-49cc-a78c-cf06a6239c28 55154-5399 HUMAN OTC DRUG Cetirizine Hydrochloride cetirizine hydrochloride TABLET, FILM COATED ORAL 20120330 ANDA ANDA076677 Cardinal Health CETIRIZINE HYDROCHLORIDE 10 mg/1 55154-5406_746cf739-5d86-4e3f-bc0d-41f77630eaa8 55154-5406 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880107 ANDA ANDA086223 Cardinal Health ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 55154-5407_746cf739-5d86-4e3f-bc0d-41f77630eaa8 55154-5407 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880407 ANDA ANDA089367 Cardinal Health ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 55154-5412_544beb4b-bf99-4ea0-982f-a9eb27f4d948 55154-5412 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071206 Cardinal Health HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] 55154-5413_544beb4b-bf99-4ea0-982f-a9eb27f4d948 55154-5413 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071207 Cardinal Health HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] 55154-5414_544beb4b-bf99-4ea0-982f-a9eb27f4d948 55154-5414 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071209 Cardinal Health HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 55154-5420_b5743b2b-9964-4489-a569-81061140357c 55154-5420 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Cardinal Health AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55154-5422_cb7720c1-c4ff-46b8-a36b-b6fe4f8e34bc 55154-5422 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Cardinal Health METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 55154-5423_5436faa2-a6d8-4a24-ba3d-7614867d697d 55154-5423 HUMAN PRESCRIPTION DRUG Promethazine HCl Promethazine HCl TABLET ORAL 20110621 ANDA ANDA084234 Cardinal Health PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-5424_a264bb4f-7dd5-4112-b4d7-1689481bc7ce 55154-5424 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030121 ANDA ANDA075209 Cardinal Health LORATADINE 10 mg/1 55154-5429_544beb4b-bf99-4ea0-982f-a9eb27f4d948 55154-5429 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071208 Cardinal Health HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] 55154-5430_93983865-362f-40a8-ba41-a8bcb99e35cb 55154-5430 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20090810 ANDA ANDA065461 Cardinal Health TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 55154-5431_b0f1d6e9-ce03-4e04-9c53-b4a5f4a5bdeb 55154-5431 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA078050 Cardinal Health ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-5432_3739729d-a52e-4226-a2f0-ee0e5ee6a401 55154-5432 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 19881209 ANDA ANDA062831 Cardinal Health CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-5433_f619ba6a-9e6a-4987-a2fb-9d0794b2f8c1 55154-5433 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-5434_f619ba6a-9e6a-4987-a2fb-9d0794b2f8c1 55154-5434 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-5435_f619ba6a-9e6a-4987-a2fb-9d0794b2f8c1 55154-5435 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-5436_f619ba6a-9e6a-4987-a2fb-9d0794b2f8c1 55154-5436 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-5437_f619ba6a-9e6a-4987-a2fb-9d0794b2f8c1 55154-5437 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-5438_14fe44aa-b594-4f49-9e8a-37af4368a2da 55154-5438 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20090810 ANDA ANDA065461 Cardinal Health TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 55154-5439_860db573-23cb-46e9-a740-b7118b725dd9 55154-5439 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 19881209 ANDA ANDA062831 Cardinal Health CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-5440_88cdc98a-01f8-425c-bf01-800e8079ab73 55154-5440 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-5441_88cdc98a-01f8-425c-bf01-800e8079ab73 55154-5441 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-5442_88cdc98a-01f8-425c-bf01-800e8079ab73 55154-5442 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-5443_88cdc98a-01f8-425c-bf01-800e8079ab73 55154-5443 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-5444_88cdc98a-01f8-425c-bf01-800e8079ab73 55154-5444 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 55154-5445_87688f92-a620-437d-904a-25c19d4270c8 55154-5445 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20030226 ANDA ANDA076400 Cardinal Health PROPRANOLOL HYDROCHLORIDE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-5446_a72ec898-4063-4783-b948-274b95f9a5c1 55154-5446 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Cardinal Health CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-5449_a72ec898-4063-4783-b948-274b95f9a5c1 55154-5449 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Cardinal Health CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-5451_6156dde3-e8f3-4b83-946a-fda1b1fc16be 55154-5451 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20091231 ANDA ANDA074215 Cardinal Health ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5452_3057c5a9-c1ed-4b98-b6f3-38684f0d70da 55154-5452 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20091231 ANDA ANDA075150 Cardinal Health CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5454_24668c7d-194f-4a2d-bb03-8c874c643c1e 55154-5454 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20110520 ANDA ANDA018659 Cardinal Health ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 55154-5455_5efa81d1-5168-457c-b5e5-b0080b938ebb 55154-5455 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20110620 ANDA ANDA073456 Cardinal Health ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-5456_554107d4-ac09-4b4c-b878-57b025312686 55154-5456 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET ORAL 20110606 UNAPPROVED DRUG OTHER Cardinal Health CHLORPHENIRAMINE MALEATE 4 mg/1 55154-5461_e7d1eb47-8e82-4d07-b7b3-e7c33509aab8 55154-5461 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20110527 ANDA ANDA070848 Cardinal Health SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 55154-5462_3057c5a9-c1ed-4b98-b6f3-38684f0d70da 55154-5462 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20091231 ANDA ANDA075150 Cardinal Health CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5463_f4cb7a8d-44e8-4dc9-809a-54333458c0ed 55154-5463 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20101013 ANDA ANDA075480 Cardinal Health ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55154-5464_a4dc8631-99c5-48a6-a5a8-72d7caaf302c 55154-5464 HUMAN PRESCRIPTION DRUG Famotidine famotidine TABLET ORAL 20101013 ANDA ANDA075704 Cardinal Health FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55154-5465_e0a1ff93-0417-411d-abc6-c4b4753c169f 55154-5465 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20110429 ANDA ANDA074434 Cardinal Health CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-5468_97563866-3e54-47ed-8345-09f335603e17 55154-5468 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin TABLET ORAL 20110818 ANDA ANDA075509 Cardinal Health DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55154-5469_97563866-3e54-47ed-8345-09f335603e17 55154-5469 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin TABLET ORAL 20110818 ANDA ANDA075509 Cardinal Health DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55154-5470_2a6dd1bd-3ec1-4541-ad89-74ff5a06d83f 55154-5470 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous Terazosin Hydrochloride Anhydrous CAPSULE ORAL 20110128 ANDA ANDA075140 Cardinal Health TERAZOSIN HYDROCHLORIDE ANHYDROUS 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55154-5471_2a6dd1bd-3ec1-4541-ad89-74ff5a06d83f 55154-5471 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous Terazosin Hydrochloride Anhydrous CAPSULE ORAL 20110128 ANDA ANDA075140 Cardinal Health TERAZOSIN HYDROCHLORIDE ANHYDROUS 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55154-5472_1f5d3154-e93e-43ba-afec-45248fe31275 55154-5472 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100210 ANDA ANDA075491 Cardinal Health BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 55154-5473_e0a1ff93-0417-411d-abc6-c4b4753c169f 55154-5473 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20110429 ANDA ANDA074434 Cardinal Health CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-5474_8180ffc0-e1e3-4947-a553-2368cf97a587 55154-5474 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health DOCUSATE SODIUM 250 mg/1 55154-5475_f4cb7a8d-44e8-4dc9-809a-54333458c0ed 55154-5475 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20101013 ANDA ANDA075480 Cardinal Health ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55154-5476_acc04ccb-f5c5-4c9f-8be9-7fc0deeb2218 55154-5476 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20110513 ANDA ANDA074388 Cardinal Health GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55154-5477_1794a770-fb44-47e6-8f9a-42b66a4c47f6 55154-5477 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20101012 ANDA ANDA070082 Cardinal Health FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-5478_dce289ff-2e70-4d6c-9e35-29f06eb8581b 55154-5478 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20110114 ANDA ANDA076704 Cardinal Health METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-5481_b9e10ab4-64b9-40d8-9799-3c4f1b469414 55154-5481 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19921105 ANDA ANDA072837 Cardinal Health DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-5482_f3b2f090-5704-4d63-a403-e1289058bffc 55154-5482 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl TABLET ORAL 20110603 UNAPPROVED DRUG OTHER Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55154-5483_af8bf978-45e7-4548-a314-beb205f36749 55154-5483 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100723 ANDA ANDA074425 Cardinal Health PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 55154-5485_5ddb50f5-f7c4-4def-a225-0da802236adf 55154-5485 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20110506 ANDA ANDA075113 Cardinal Health LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-5487_bfab8455-8937-4ac9-a71a-960bbb298beb 55154-5487 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20090915 ANDA ANDA075976 Cardinal Health METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 55154-5488_c80bbd11-c231-4110-871a-a1a1313010bf 55154-5488 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120712 ANDA ANDA074587 Cardinal Health VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-5489_4c5c367b-8669-4b91-87db-9d5a42fff4d8 55154-5489 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20110429 ANDA ANDA074700 Cardinal Health BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-5491_5ddb50f5-f7c4-4def-a225-0da802236adf 55154-5491 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20110506 ANDA ANDA075113 Cardinal Health LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-5492_5b80786b-f89e-4909-8baf-e27995dfa29f 55154-5492 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 19981130 ANDA ANDA074739 Cardinal Health AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 55154-5494_2e3a4168-a459-423a-823c-e45cca3b886f 55154-5494 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20100331 ANDA ANDA075272 Cardinal Health BUSPIRONE HYDROCHLORIDE 5 mg/1 55154-5495_a7dc3e65-a424-45c4-aeff-01b4c5f24a8c 55154-5495 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine hydrochloride CAPSULE ORAL 20110711 ANDA ANDA075207 Cardinal Health FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-5496_36714f7c-cd7f-4a8b-819f-cca1c7da4742 55154-5496 HUMAN PRESCRIPTION DRUG Phenytoin Sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20110128 ANDA ANDA040298 Cardinal Health PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-5499_6156dde3-e8f3-4b83-946a-fda1b1fc16be 55154-5499 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20091231 ANDA ANDA074215 Cardinal Health ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5504_b9e10ab4-64b9-40d8-9799-3c4f1b469414 55154-5504 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19921105 ANDA ANDA073185 Cardinal Health DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-5509_5476b43b-b796-45f4-bb3f-e931b027e5b7 55154-5509 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20111006 ANDA ANDA070035 Cardinal Health METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 55154-5510_5083f760-7064-47b2-b93c-ccf005bb34b1 55154-5510 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20110823 ANDA ANDA070184 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 55154-5511_5efa81d1-5168-457c-b5e5-b0080b938ebb 55154-5511 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20110620 ANDA ANDA073457 Cardinal Health ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-5512_dce289ff-2e70-4d6c-9e35-29f06eb8581b 55154-5512 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20110114 ANDA ANDA076704 Cardinal Health METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-5516_83540d64-81ba-441b-922b-cf18cc12b13b 55154-5516 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 20110513 ANDA ANDA074621 Cardinal Health MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 55154-5517_93a5ee92-d832-484e-b80b-4b43bef5c67e 55154-5517 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20110204 ANDA ANDA040424 Cardinal Health SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 55154-5523_b9e10ab4-64b9-40d8-9799-3c4f1b469414 55154-5523 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19921105 ANDA ANDA073186 Cardinal Health DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-5526_5083f760-7064-47b2-b93c-ccf005bb34b1 55154-5526 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20110823 ANDA ANDA072801 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 55154-5530_5f35a106-3eb9-4adf-b37c-b6871bb7dd93 55154-5530 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20110120 ANDA ANDA080738 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 55154-5534_24668c7d-194f-4a2d-bb03-8c874c643c1e 55154-5534 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20110520 ANDA ANDA018659 Cardinal Health ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 55154-5537_5d043b8d-600c-42c8-98ef-09b281d9bc44 55154-5537 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20110520 ANDA ANDA074625 Cardinal Health OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-5539_1794a770-fb44-47e6-8f9a-42b66a4c47f6 55154-5539 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20101012 ANDA ANDA018487 Cardinal Health FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-5540_1794a770-fb44-47e6-8f9a-42b66a4c47f6 55154-5540 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20101012 ANDA ANDA018487 Cardinal Health FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-5546_91fd7c78-5c53-41d8-9d20-be482ecd5905 55154-5546 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 19890920 ANDA ANDA063029 Cardinal Health CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 55154-5548_ba6ec9f1-18a5-43d6-840e-cfaa5e233c54 55154-5548 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20110114 ANDA ANDA088628 Cardinal Health ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII 55154-5550_7d4044f8-eaf0-497a-a6b8-f50e3a1a8573 55154-5550 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20101217 ANDA ANDA077657 Cardinal Health LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5552_2f38c991-ad2c-4c78-907a-dd6bcb4fde15 55154-5552 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 500 mg/1 55154-5553_6156dde3-e8f3-4b83-946a-fda1b1fc16be 55154-5553 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20091231 ANDA ANDA074215 Cardinal Health ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5554_1984bbf4-e376-44ce-b640-c1a163bbc889 55154-5554 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20091120 ANDA ANDA070325 Cardinal Health DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5561_9218e7fb-8020-4e73-92a6-ab1c46b0c866 55154-5561 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20110708 ANDA ANDA070317 Cardinal Health CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55154-5562_9218e7fb-8020-4e73-92a6-ab1c46b0c866 55154-5562 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20110708 ANDA ANDA070317 Cardinal Health CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55154-5564_db094fd7-6b3d-44ad-b76d-67ee137d0661 55154-5564 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20120925 ANDA ANDA088496 Cardinal Health HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 55154-5567_5476b43b-b796-45f4-bb3f-e931b027e5b7 55154-5567 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20111006 ANDA ANDA070044 Cardinal Health METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 55154-5570_9218e7fb-8020-4e73-92a6-ab1c46b0c866 55154-5570 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20110708 ANDA ANDA070317 Cardinal Health CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55154-5571_115ba629-0a6b-49ae-ba62-a24823818447 55154-5571 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20110715 ANDA ANDA073144 Cardinal Health CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55154-5581_6bd3af98-35ae-45d7-8f9a-175031803b82 55154-5581 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20110520 ANDA ANDA074467 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55154-5585_1bbbfe22-3aac-4e71-99ae-56faee122c4f 55154-5585 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 20110727 ANDA ANDA072741 Cardinal Health LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 55154-5588_d7795df3-be5f-4250-8ca5-b4e73826e57b 55154-5588 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20101104 ANDA ANDA074226 Cardinal Health GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55154-5590_7d4044f8-eaf0-497a-a6b8-f50e3a1a8573 55154-5590 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20101217 ANDA ANDA077657 Cardinal Health LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5591_f16f87c3-bcf1-4daf-892c-d5104819a6bc 55154-5591 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20110204 ANDA ANDA070920 Cardinal Health TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5599_ca9501ed-9043-46e6-b11e-66caba43f99e 55154-5599 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 20110816 ANDA ANDA040319 Cardinal Health DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 55154-5605_371ef590-b063-43ae-9532-135194cf13dc 55154-5605 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride POWDER, FOR SOLUTION ORAL 20091101 UNAPPROVED DRUG OTHER Cardinal Health POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55154-5606_a0f63765-a291-486c-b198-68a7f2414b83 55154-5606 HUMAN PRESCRIPTION DRUG Pacerone Amiodarone Hydrochloride TABLET ORAL 20110119 ANDA ANDA075135 Cardinal Health AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 55154-5609_4483174d-be59-4f2f-bccb-8356ca79a14f 55154-5609 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Cardinal Health POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55154-5610_4483174d-be59-4f2f-bccb-8356ca79a14f 55154-5610 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Cardinal Health POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55154-5611_1c639b6b-a6b1-4cc8-a2b2-29af89dedaa3 55154-5611 HUMAN PRESCRIPTION DRUG Klor-Con M20 Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 Cardinal Health POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55154-5614_1c639b6b-a6b1-4cc8-a2b2-29af89dedaa3 55154-5614 HUMAN PRESCRIPTION DRUG Klor-Con M10 Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 Cardinal Health POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55154-5616_70a38e96-9a2f-49f9-bb37-68a919785b47 55154-5616 HUMAN PRESCRIPTION DRUG Sorine Sotalol Hydrochloride TABLET ORAL 20110215 ANDA ANDA075500 Cardinal Health SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 55154-5618_ad11f9b9-07e9-4a84-b68a-0070bbd93af9 55154-5618 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Cardinal Health WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-5619_ad11f9b9-07e9-4a84-b68a-0070bbd93af9 55154-5619 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Cardinal Health WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-5620_ad11f9b9-07e9-4a84-b68a-0070bbd93af9 55154-5620 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Cardinal Health WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-5621_ad11f9b9-07e9-4a84-b68a-0070bbd93af9 55154-5621 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Cardinal Health WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-5623_539c3662-ebfe-4269-ade1-38f0931726af 55154-5623 HUMAN PRESCRIPTION DRUG Midodrine HCl midodrine hydrochloride TABLET ORAL 20041103 ANDA ANDA076725 Cardinal Health MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 55154-5624_5556c5f6-04ff-454e-a60a-bd24fbb93fa2 55154-5624 HUMAN PRESCRIPTION DRUG Klor-Con M potassium chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 Cardinal Health POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55154-5625_7d0af648-051a-4f28-861b-428ceaa6bb8d 55154-5625 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078182 Cardinal Health DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-5627_7d0af648-051a-4f28-861b-428ceaa6bb8d 55154-5627 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078182 Cardinal Health DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-5628_254605fb-232a-4e08-a1f8-96bb6d06afee 55154-5628 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20111107 ANDA ANDA074625 Cardinal Health OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-5630_e86adbc4-a03e-4f43-a88c-b9015d18ff9f 55154-5630 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084112 Cardinal Health CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-5631_e86adbc4-a03e-4f43-a88c-b9015d18ff9f 55154-5631 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084113 Cardinal Health CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-5632_b2c3b1f9-effe-4fe8-898a-463f82949095 55154-5632 HUMAN PRESCRIPTION DRUG Midodrine HCl midodrine hydrochloride TABLET ORAL 20041103 ANDA ANDA076725 Cardinal Health MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 55154-5650_90bbeb5d-61b3-4415-8a3c-5632052b8bba 55154-5650 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101015 ANDA ANDA085762 Cadinal Health ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 55154-5652_103fc54c-3102-4068-b7c8-bd68c791c001 55154-5652 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20110401 ANDA ANDA084769 Cardinal Health CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5653_1984bbf4-e376-44ce-b640-c1a163bbc889 55154-5653 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20091120 ANDA ANDA070325 Cardinal Health DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5655_7d4044f8-eaf0-497a-a6b8-f50e3a1a8573 55154-5655 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20101217 ANDA ANDA077657 Cardinal Health LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5656_2b9fcae5-4a70-40e9-98ef-8269f827be20 55154-5656 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED ORAL 20110204 ANDA ANDA075986 Cardinal Health TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 55154-5657_1fb34ad4-df1c-459b-867d-18d1d338fd75 55154-5657 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110401 ANDA ANDA084112 Cardinal Health CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-5659_97563866-3e54-47ed-8345-09f335603e17 55154-5659 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin TABLET ORAL 20110818 ANDA ANDA075509 Cardinal Health DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55154-5660_f51fc098-1e7c-4f9d-b05e-dc029ed14ae7 55154-5660 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20110128 ANDA ANDA040185 Cardinal Health PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-5661_f3f800e2-4bf8-40ba-9c04-bc4d43bdab3f 55154-5661 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-release diltiazem hydrochloride CAPSULE ORAL 20110816 ANDA ANDA074910 Cardinal Health DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-5663_74f37abc-005f-412f-9ce6-3c080c29cfd3 55154-5663 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 20110513 ANDA ANDA087127 Cardinal Health MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 55154-5665_e50f9fe8-95a8-478b-ba4b-211715e10694 55154-5665 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 20110617 ANDA ANDA086009 Cardinal Health AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 55154-5666_b03dca94-2a4f-43bc-9413-7edf1a54050d 55154-5666 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20110818 ANDA ANDA075451 Cardinal Health LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-5667_e5b78cf7-675c-49fc-8f1b-1e9c6c01ea36 55154-5667 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20100114 ANDA ANDA076110 Cardinal Health TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-5671_1b67797e-c04a-483f-ad72-7fc15e3abbfa 55154-5671 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20110920 ANDA ANDA070213 Cardinal Health PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-5672_0a3f7bdb-6c3c-4ee2-aaa6-70c7f5495819 55154-5672 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20110816 ANDA ANDA076430 Cardinal Health BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55154-5673_0a3f7bdb-6c3c-4ee2-aaa6-70c7f5495819 55154-5673 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20110816 ANDA ANDA076430 Cardinal Health BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55154-5675_378d5239-02a5-4dda-94be-302ef6b7beae 55154-5675 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20110218 ANDA ANDA077316 Cardinal Health CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55154-5676_378d5239-02a5-4dda-94be-302ef6b7beae 55154-5676 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20110218 ANDA ANDA077316 Cardinal Health CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55154-5677_378d5239-02a5-4dda-94be-302ef6b7beae 55154-5677 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20110218 ANDA ANDA077316 Cardinal Health CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55154-5678_378d5239-02a5-4dda-94be-302ef6b7beae 55154-5678 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20110218 ANDA ANDA077316 Cardinal Health CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55154-5679_7de83e93-a4b7-40c6-9c35-c498360128d7 55154-5679 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 20101029 NDA AUTHORIZED GENERIC NDA018858 Cardinal Health INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-5680_9e4c1c56-0a7e-45f9-9c0a-e976e3c3632b 55154-5680 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20091130 ANDA ANDA076122 Cardinal Health MIRTAZAPINE 30 mg/1 55154-5681_0d809b21-738a-4dd4-b450-b767a5019ee1 55154-5681 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20110114 ANDA ANDA075876 Cardinal Health OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55154-5682_1b67797e-c04a-483f-ad72-7fc15e3abbfa 55154-5682 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20110920 ANDA ANDA070213 Cardinal Health PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-5683_d4ca7c46-e274-492e-85de-4022373a2eb6 55154-5683 HUMAN PRESCRIPTION DRUG Valproic Acid valproic acid CAPSULE ORAL 20120810 ANDA ANDA073229 Cardinal Health VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-5684_ca9501ed-9043-46e6-b11e-66caba43f99e 55154-5684 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 20110816 ANDA ANDA040317 Cardinal Health DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 55154-5685_3d4ada43-f753-4c23-8969-bd61edcaf397 55154-5685 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20110708 ANDA ANDA077578 Cardinal Health FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 55154-5686_74b01bc9-31fd-4374-ad9c-17c5f2ddf94c 55154-5686 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20101029 ANDA ANDA075640 Cardinal Health HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55154-5687_d4ce6e9d-c292-4ff7-95a6-81567a80122f 55154-5687 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20110114 ANDA ANDA076698 Cardinal Health METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 55154-5688_d4ce6e9d-c292-4ff7-95a6-81567a80122f 55154-5688 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20110114 ANDA ANDA076698 Cardinal Health METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 55154-5689_2d4a80d9-cf88-4173-a42e-013bf8633257 55154-5689 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20110513 ANDA ANDA088467 Cardinal Health HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-5692_8ec48613-5892-4ec0-801b-3429c8eae185 55154-5692 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100114 ANDA ANDA076418 Cardinal Health AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-5696_fb975e04-7188-4d5b-a286-5edd257ae8ab 55154-5696 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride Midodrine Hydrochloride TABLET ORAL 20110114 ANDA ANDA076577 Cardinal Health MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 55154-5697_12d5bd57-e599-4fb7-8959-5f08b9497578 55154-5697 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20120815 ANDA ANDA040596 Cardinal Health PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55154-5698_4ece0621-3404-4b7a-ab09-845196f7ac64 55154-5698 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20120829 ANDA ANDA076919 Cardinal Health LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-5699_4ece0621-3404-4b7a-ab09-845196f7ac64 55154-5699 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20120829 ANDA ANDA076919 Cardinal Health LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-5701_e1badec1-77bd-481a-a93c-3150eaeee814 55154-5701 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION INTRAVENOUS 19900930 ANDA ANDA018579 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-5704_e1badec1-77bd-481a-a93c-3150eaeee814 55154-5704 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION INTRAVENOUS 19900930 ANDA ANDA018579 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-5705_e1badec1-77bd-481a-a93c-3150eaeee814 55154-5705 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION INTRAVENOUS 19900930 ANDA ANDA018579 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-5706_7bd2c1cf-31c0-49c7-a856-f238a46f6f1f 55154-5706 HUMAN PRESCRIPTION DRUG Droperidol Droperidol INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19900930 ANDA ANDA072123 Cardinal Health DROPERIDOL 2.5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 55154-5707_8ed678e2-8a6a-418d-af99-af46d54ae5c4 55154-5707 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphates Dexamethasone Phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 19900930 ANDA ANDA087440 Cardinal Health DEXAMETHASONE PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-5708_b3bde819-b269-4775-aeda-3270f127fc08 55154-5708 HUMAN PRESCRIPTION DRUG Dopamine HCl Dopamine HCl INJECTION, SOLUTION INTRAVENOUS 19900930 ANDA ANDA070820 Cardinal Health DOPAMINE HYDROCHLORIDE 80 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-5712_b3bde819-b269-4775-aeda-3270f127fc08 55154-5712 HUMAN PRESCRIPTION DRUG Dopamine HCl Dopamine HCl INJECTION, SOLUTION INTRAVENOUS 19870211 ANDA ANDA070799 Cardinal Health DOPAMINE HYDROCHLORIDE 40 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-5715_e89e2cc9-9880-42cd-a2ca-b7391f12ee68 55154-5715 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110707 UNAPPROVED DRUG OTHER Cardinal Health ATROPINE SULFATE .4 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-5717_675771e3-db30-4e9c-928c-80f9fae924a3 55154-5717 HUMAN PRESCRIPTION DRUG Calcium Chloride Calcium Chloride INJECTION INTRAVENOUS 20110614 UNAPPROVED DRUG OTHER Cardinal Health CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 55154-5719_218c002d-283b-4008-bc38-365cfd53830d 55154-5719 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970630 ANDA ANDA040136 Cardinal Health HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-5722_cc2e4a4b-633f-4896-b801-05439ccdc426 55154-5722 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20111025 ANDA ANDA089335 Cardinal Health GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 55154-5724_bd6a0d6e-562a-4364-81a5-c609f3936327 55154-5724 HUMAN PRESCRIPTION DRUG Vasopressin Vasopressin INJECTION INTRAMUSCULAR 20111017 UNAPPROVED DRUG OTHER Cardinal Health VASOPRESSIN 20 [USP'U]/mL 55154-5725_a70f9b52-d246-4ed7-a651-57d72ccd4666 55154-5725 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 19900930 ANDA ANDA087408 Cardinal Health HYDROXYZINE HYDROCHLORIDE 50 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 55154-5728_a70f9b52-d246-4ed7-a651-57d72ccd4666 55154-5728 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 19900930 ANDA ANDA087408 Cardinal Health HYDROXYZINE HYDROCHLORIDE 25 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 55154-5729_8e71fdb7-b7bf-4228-88e2-b9922b5c5de5 55154-5729 HUMAN PRESCRIPTION DRUG Cyanocobalamin cyanocobalamin INJECTION, SOLUTION INTRAMUSCULAR 20030529 ANDA ANDA080737 Cardinal Health CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 55154-5730_c90fca12-12fb-4cf6-bd6f-83bc0d95df81 55154-5730 HUMAN PRESCRIPTION DRUG Acetylcysteine Acetylcysteine INHALANT ORAL; RESPIRATORY (INHALATION) 20110506 UNAPPROVED DRUG OTHER Cardinal Health ACETYLCYSTEINE 100 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 55154-5731_c90fca12-12fb-4cf6-bd6f-83bc0d95df81 55154-5731 HUMAN PRESCRIPTION DRUG Acetylcysteine Acetylcysteine INHALANT ORAL; RESPIRATORY (INHALATION) 20110506 UNAPPROVED DRUG OTHER Cardinal Health ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 55154-5732_e89e2cc9-9880-42cd-a2ca-b7391f12ee68 55154-5732 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110707 UNAPPROVED DRUG OTHER Cardinal Health ATROPINE SULFATE 1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-5735_4e41ddb6-435a-48da-a38a-2bbe1f318f3a 55154-5735 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19900930 UNAPPROVED DRUG OTHER Cardinal Health PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 55154-5737_cc2e4a4b-633f-4896-b801-05439ccdc426 55154-5737 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20111025 ANDA ANDA089335 Cardinal Health GLYCOPYRROLATE 1 mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 55154-5738_3d066575-f361-4fcc-b1f3-3ae2be447719 55154-5738 HUMAN PRESCRIPTION DRUG Sodium Phosphates sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER Cardinal Health SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 142; 276 mg/mL; mg/mL 55154-5739_cc2e4a4b-633f-4896-b801-05439ccdc426 55154-5739 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20111025 ANDA ANDA089335 Cardinal Health GLYCOPYRROLATE .4 mg/2mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 55154-5740_8e71fdb7-b7bf-4228-88e2-b9922b5c5de5 55154-5740 HUMAN PRESCRIPTION DRUG Cyanocobalamin cyanocobalamin INJECTION, SOLUTION INTRAMUSCULAR 19900930 ANDA ANDA080737 Cardinal Health CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 55154-5741_61ce2a92-df17-4994-bea0-edda0d6774bc 55154-5741 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 20100211 ANDA ANDA090386 Cardinal Health METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-5750_2565ff96-e08a-41fb-87d3-e74d2c9791c0 55154-5750 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20101114 ANDA ANDA081297 Cardinal Health BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 55154-5754_1bbfacc2-5afc-4c6c-9301-8b17046916ec 55154-5754 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110120 ANDA ANDA071523 Cardinal Health TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 55154-5759_284f1e3c-45e4-40fc-a56a-bfacec331016 55154-5759 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110131 ANDA ANDA065265 Cardinal Health AZITHROMYCIN MONOHYDRATE 100 mg/mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55154-5761_1bbfacc2-5afc-4c6c-9301-8b17046916ec 55154-5761 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110120 ANDA ANDA071524 Cardinal Health TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 55154-5762_c49fb1f7-5fa6-47cb-bc98-3623eb7c637b 55154-5762 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071525 Cardinal Health TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 55154-5764_c49fb1f7-5fa6-47cb-bc98-3623eb7c637b 55154-5764 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 Cardinal Health TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 55154-5765_c49fb1f7-5fa6-47cb-bc98-3623eb7c637b 55154-5765 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071524 Cardinal Health TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 55154-5766_044dc140-2b4e-4baf-9a75-0b3f769e1229 55154-5766 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20040601 ANDA ANDA076346 Cardinal Health TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-5767_0548145e-6b20-4843-9bcc-cf270ea2f072 55154-5767 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20040601 ANDA ANDA076346 Cardinal Health TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-5768_feeff487-0825-477a-8e81-73c309f0cb57 55154-5768 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071525 Cardinal Health TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 55154-5821_2594e3d8-af38-4ba0-9370-0a261e2d1042 55154-5821 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20091207 ANDA ANDA088467 Cardinal Health HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-5827_2594e3d8-af38-4ba0-9370-0a261e2d1042 55154-5827 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20091207 ANDA ANDA089097 Cardinal Health HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-5837_e07ea561-9afe-40c7-8f3a-cfe228282a45 55154-5837 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 500 mg/1 55154-5840_cc7472f1-149d-4842-a742-bf8f1b895e93 55154-5840 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health IBUPROFEN 200 mg/1 55154-5842_edb534b0-2117-4c82-a835-602234fbb73c 55154-5842 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 325 mg/1 55154-5844_fd03ff05-2c6d-4f10-a872-39efbf196bdb 55154-5844 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health BACITRACIN 500 1/1 55154-5864_ded106e0-3d90-4ccd-8aa1-161dd65dcd84 55154-5864 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087128 Cardinal Health MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 55154-5867_2c4e6819-3dd6-4ca9-91dc-ba9667cf2794 55154-5867 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20140114 NDA AUTHORIZED GENERIC NDA020405 Cardinal Health DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 55154-5868_4958c12f-c6b3-4e79-8669-2fe2eed0f6ee 55154-5868 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20001201 ANDA ANDA065055 Cardinal Health DOXYCYCLINE 100 mg/1 55154-5870_8764bcdf-dae0-4250-9c07-82db82caf2bb 55154-5870 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended-Release Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20090804 ANDA ANDA078445 Cardinal Health DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-5871_488eaa1a-3464-40ef-ab74-61872dd459cc 55154-5871 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Cardinal Health DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-5875_1aec8379-bd0d-45b3-8411-df650ccc6b3f 55154-5875 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20080326 NDA NDA018569 Cardinal Health FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-5876_1f88e909-ef24-452a-a34a-edc8bd65e8ea 55154-5876 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET ORAL 20090610 ANDA ANDA075133 Cardinal Health LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-5877_6a25e6d5-d2be-4121-adb2-3fe43d3a607f 55154-5877 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Cardinal Health OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 55154-5878_45ac70ef-fd12-4957-823c-ac934efa2bad 55154-5878 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100324 ANDA ANDA076045 Cardinal Health LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5880_105e5e20-8501-461e-b9cc-50e05b879157 55154-5880 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Cardinal Health SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-5881_55857ad1-7d09-4a66-9448-53aa7ef433b1 55154-5881 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 Cardinal Health RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 55154-5882_51925501-ab5b-4e12-a67e-ec2b4b592e83 55154-5882 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20090610 ANDA ANDA077002 Cardinal Health DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 55154-5884_ed57fc60-ecb2-419e-b09f-3c518dcf3d04 55154-5884 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Cardinal Health ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-5885_f6cb5d3d-b65b-470b-98ab-9d3f1fd9a438 55154-5885 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080402 ANDA ANDA074342 Cardinal Health ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5886_45ac70ef-fd12-4957-823c-ac934efa2bad 55154-5886 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100324 ANDA ANDA076045 Cardinal Health LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5887_b4fedd08-f0fd-4cf0-89be-282289f78691 55154-5887 HUMAN OTC DRUG peg 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091008 ANDA ANDA090685 Cardinal Health POLYETHYLENE GLYCOL 3350 17 g/17g 55154-5888_29761165-624c-4831-9129-a27a6b3ef9c7 55154-5888 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Cardinal Health METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 55154-5889_c3906864-831d-48ba-8883-c14851405d76 55154-5889 HUMAN OTC DRUG Senna Plus standardized senna concentrate and docusate sodium TABLET ORAL 20100114 UNAPPROVED DRUG OTHER Cardinal Health DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 55154-5892_8a43ac4e-efb5-4d8b-90cb-ce351bff754e 55154-5892 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Cardinal Health LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-5894_1441948b-3c7f-455f-975e-32b6016f4f3e 55154-5894 HUMAN OTC DRUG Aspir Low Aspirin TABLET ORAL 20110524 OTC MONOGRAPH FINAL part343 Cardinal Health ASPIRIN 81 mg/1 55154-5895_22d35e95-719c-4d5a-8c16-15a522b01e58 55154-5895 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20091102 ANDA ANDA078216 Cardinal Health CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-5896_6a25e6d5-d2be-4121-adb2-3fe43d3a607f 55154-5896 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Cardinal Health OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 55154-5897_268cc255-1445-4a90-b218-60d25d0035d2 55154-5897 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131201 ANDA ANDA076710 Cardinal Health LEVOFLOXACIN 500 mg/1 55154-5898_268cc255-1445-4a90-b218-60d25d0035d2 55154-5898 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131201 ANDA ANDA076710 Cardinal Health LEVOFLOXACIN 750 mg/1 55154-5899_288d0479-6538-4842-87b5-a9ebd96af1ce 55154-5899 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20131130 ANDA ANDA079088 Cardinal Health RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 55154-5925_759fe013-c185-4373-ab70-cee4e7cd49c1 55154-5925 HUMAN PRESCRIPTION DRUG Pitressin vasopressin INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20071001 UNAPPROVED DRUG OTHER Cardinal Health VASOPRESSIN 20 [USP'U]/mL 55154-5952_d11575fe-64be-446a-b464-89f43560e271 55154-5952 HUMAN PRESCRIPTION DRUG Pentasa mesalamine CAPSULE ORAL 19930510 NDA NDA020049 Cardinal Health MESALAMINE 250 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 55154-5953_21bc55ec-5f23-4d0b-9488-d5b08b7c0fc2 55154-5953 HUMAN PRESCRIPTION DRUG Fosrenol lanthanum carbonate TABLET, CHEWABLE ORAL 20041026 NDA NDA021468 Cardinal Health LANTHANUM CARBONATE 500 mg/1 55154-5976_fd13743d-ec41-4782-8068-4a18d4a6eb4e 55154-5976 HUMAN PRESCRIPTION DRUG Metoclopramide hydrochloride Metoclopramide hydrochloride TABLET ORAL 19851017 ANDA ANDA070581 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 55154-5979_600d5e89-d8ec-4535-ac0d-2f5e0247abf8 55154-5979 HUMAN PRESCRIPTION DRUG nifedipine nifedipine CAPSULE, LIQUID FILLED ORAL 19910108 ANDA ANDA072579 Cardinal Health NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-5980_600d5e89-d8ec-4535-ac0d-2f5e0247abf8 55154-5980 HUMAN PRESCRIPTION DRUG nifedipine nifedipine CAPSULE, LIQUID FILLED ORAL 19900920 ANDA ANDA072556 Cardinal Health NIFEDIPINE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-5981_98c12507-3579-41d5-8b38-2d298daceea6 55154-5981 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19931031 ANDA ANDA074342 Cardinal Health ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5982_98c12507-3579-41d5-8b38-2d298daceea6 55154-5982 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19931031 ANDA ANDA074342 Cardinal Health ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5983_98c12507-3579-41d5-8b38-2d298daceea6 55154-5983 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19931031 ANDA ANDA074342 Cardinal Health ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5984_f90f8801-e566-4288-b661-f31450aff84a 55154-5984 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 Cardinal Health CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5985_f90f8801-e566-4288-b661-f31450aff84a 55154-5985 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 Cardinal Health CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5986_f90f8801-e566-4288-b661-f31450aff84a 55154-5986 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 Cardinal Health CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-5992_939f7526-062f-48fd-9aee-4b068fd531be 55154-5992 HUMAN PRESCRIPTION DRUG Glipizide ER glipizide TABLET, EXTENDED RELEASE ORAL 19940426 NDA NDA020329 Cardinal Health GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55154-5996_120de758-f102-470a-892d-a61b18ff8f71 55154-5996 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 20060115 ANDA ANDA080172 Cardinal Health PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 55154-5999_111168b3-0218-4a54-8d6f-0daaea3222a1 55154-5999 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20040214 ANDA ANDA075694 Cardinal Health GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-6027_821309e9-249a-4eac-a20c-e1d9978a82d7 55154-6027 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Cardinal Health PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-6031_69fba983-d011-487c-8b7a-9e648d46d516 55154-6031 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Cardinal Health RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 55154-6032_69fba983-d011-487c-8b7a-9e648d46d516 55154-6032 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Cardinal Health RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 55154-6033_69fba983-d011-487c-8b7a-9e648d46d516 55154-6033 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Cardinal Health RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 55154-6050_3f175b24-c1e8-4b91-b795-2a3e74087181 55154-6050 HUMAN OTC DRUG Feverall Acetaminophen SUPPOSITORY RECTAL 20110606 ANDA ANDA018337 Cardinal Health ACETAMINOPHEN 650 mg/1 55154-6125_48dc0f60-a62a-44db-b970-df043df6202e 55154-6125 HUMAN PRESCRIPTION DRUG BENICAR HCT olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 Cardinal Health HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5; 20 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55154-6126_af6c49f2-b8da-451e-8661-317156536d10 55154-6126 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 Cardinal Health OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-6127_af6c49f2-b8da-451e-8661-317156536d10 55154-6127 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 Cardinal Health OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-6128_48dc0f60-a62a-44db-b970-df043df6202e 55154-6128 HUMAN PRESCRIPTION DRUG BENICAR HCT olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 Cardinal Health HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55154-6129_48dc0f60-a62a-44db-b970-df043df6202e 55154-6129 HUMAN PRESCRIPTION DRUG BENICAR HCT olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 Cardinal Health HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55154-6130_9932c625-a088-45ff-a0dd-5b647766b912 55154-6130 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 Cardinal Health OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-6131_ee231277-3f77-4e82-a4ff-ead983b38563 55154-6131 HUMAN PRESCRIPTION DRUG BENICAR HCT olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 Cardinal Health HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5; 20 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55154-6151_ac899907-83fb-4c12-8ec6-9335b1392462 55154-6151 HUMAN OTC DRUG Senna-S Senna Concentrate/Docusate Sodium TABLET ORAL 20110603 UNAPPROVED DRUG OTHER Cardinal Health DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 55154-6157_e4bd3bb1-9f41-43f5-a2ab-50ab2e641995 55154-6157 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20091218 ANDA ANDA075752 Cardinal Health LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-6158_e4bd3bb1-9f41-43f5-a2ab-50ab2e641995 55154-6158 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20091218 ANDA ANDA075752 Cardinal Health LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-6159_e4bd3bb1-9f41-43f5-a2ab-50ab2e641995 55154-6159 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20091218 ANDA ANDA075752 Cardinal Health LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-6163_a5ea0a61-bc61-45b5-90e1-37baa5326117 55154-6163 HUMAN OTC DRUG Senna Gen Sennosides TABLET ORAL 20110607 UNAPPROVED DRUG OTHER Cardinal Health SENNOSIDES 8.6 mg/1 55154-6164_a279d030-edf2-41f9-9a68-8f97532e2753 55154-6164 HUMAN PRESCRIPTION DRUG Ciprofloxacin hydrochloride Ciprofloxacin hydrochloride TABLET ORAL 20091009 ANDA ANDA076089 Cardinal Health CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55154-6176_e4bd3bb1-9f41-43f5-a2ab-50ab2e641995 55154-6176 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20091218 ANDA ANDA075752 Cardinal Health LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-6177_a279d030-edf2-41f9-9a68-8f97532e2753 55154-6177 HUMAN PRESCRIPTION DRUG Ciprofloxacin hydrochloride Ciprofloxacin hydrochloride TABLET ORAL 20091009 ANDA ANDA076089 Cardinal Health CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55154-6178_bf6157b3-b561-43db-9c62-14ac48d72358 55154-6178 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20101201 ANDA ANDA076077 Cardinal Health FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55154-6187_a279d030-edf2-41f9-9a68-8f97532e2753 55154-6187 HUMAN PRESCRIPTION DRUG Ciprofloxacin hydrochloride Ciprofloxacin hydrochloride TABLET ORAL 20091009 ANDA ANDA076089 Cardinal Health CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55154-6188_8c6b6588-d4a2-4377-a113-931666db2a9a 55154-6188 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20040428 ANDA ANDA076017 Cardinal Health GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-6191_e4bd3bb1-9f41-43f5-a2ab-50ab2e641995 55154-6191 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20091218 ANDA ANDA075752 Cardinal Health LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-6194_bf6157b3-b561-43db-9c62-14ac48d72358 55154-6194 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20101201 ANDA ANDA076077 Cardinal Health FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55154-6213_d1043177-2247-47e9-8501-119c10a731c2 55154-6213 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20100112 ANDA ANDA076704 Cardinal Health METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-6218_fd20c066-5f43-4844-8d29-1a5ffda61a9b 55154-6218 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine Hydrochloride TABLET ORAL 19970127 ANDA ANDA074796 Cardinal Health GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55154-6223_35df0cb2-ca82-49ee-afad-4431db5708d6 55154-6223 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19910918 ANDA ANDA072741 Cardinal Health LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 55154-6228_e9ce6841-9bf6-42c2-a56d-c8d08bac2d9e 55154-6228 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20110519 ANDA ANDA040424 Cardinal Health SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 55154-6230_35918293-0c0b-4796-b237-ac596afab777 55154-6230 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100728 ANDA ANDA076644 Cardinal Health OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-6231_35918293-0c0b-4796-b237-ac596afab777 55154-6231 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100728 ANDA ANDA076702 Cardinal Health OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-6236_4fb7f56c-b320-418a-b187-469aed5af394 55154-6236 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 Cardinal Health ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 55154-6237_19fc5f11-e83f-4ff2-b92f-33e9c3f6a7cb 55154-6237 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20091119 ANDA ANDA076919 Cardinal Health LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-6239_bc3ecbf6-0abe-44bf-97a4-630fb5b92320 55154-6239 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED ORAL 20020621 ANDA ANDA075986 Cardinal Health TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 55154-6240_3c3b7910-ca9d-46d9-9ed4-376d99af40df 55154-6240 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20091130 ANDA ANDA076122 Cardinal Health MIRTAZAPINE 15 mg/1 55154-6241_3c3b7910-ca9d-46d9-9ed4-376d99af40df 55154-6241 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20091130 ANDA ANDA076122 Cardinal Health MIRTAZAPINE 30 mg/1 55154-6242_2a585868-c41d-499a-9d81-e3a152e8ab44 55154-6242 HUMAN PRESCRIPTION DRUG Estradiol estradiol TABLET ORAL 20091217 ANDA ANDA040326 Cardinal Health ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 55154-6243_4b6435e3-d102-449f-b21b-ac53130b3c78 55154-6243 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090921 ANDA ANDA074425 Cardinal Health PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 55154-6244_d0708534-89cb-4c2c-a076-c19e7f57ffcf 55154-6244 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20101112 ANDA ANDA076288 Cardinal Health RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 55154-6245_d0708534-89cb-4c2c-a076-c19e7f57ffcf 55154-6245 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20101112 ANDA ANDA076288 Cardinal Health RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 55154-6246_d0708534-89cb-4c2c-a076-c19e7f57ffcf 55154-6246 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20101112 ANDA ANDA072688 Cardinal Health RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 55154-6247_d0708534-89cb-4c2c-a076-c19e7f57ffcf 55154-6247 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20101112 ANDA ANDA072688 Cardinal Health RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 55154-6248_d0708534-89cb-4c2c-a076-c19e7f57ffcf 55154-6248 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20101112 ANDA ANDA072688 Cardinal Health RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 55154-6253_19fc5f11-e83f-4ff2-b92f-33e9c3f6a7cb 55154-6253 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20091119 ANDA ANDA076919 Cardinal Health LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-6256_49f50d5e-3738-4f3a-8999-28c6a5ff2cd7 55154-6256 HUMAN PRESCRIPTION DRUG Tizanidine tizanidine TABLET ORAL 20130321 ANDA ANDA076354 Cardinal Health TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55154-6260_4e1b05fd-c41e-4ccb-af52-65e5066b8e21 55154-6260 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20090828 ANDA ANDA078309 Cardinal Health LEVALBUTEROL HYDROCHLORIDE 1.25 mg/.5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 55154-6262_ff007079-b14e-4462-bc20-577595805100 55154-6262 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil mycophenolate mofetil CAPSULE ORAL 20111025 ANDA ANDA065520 Cardinal Health MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 55154-6263_dfe06d6b-eb1c-489f-b32c-d3ed00c4db04 55154-6263 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20120123 ANDA ANDA090970 Cardinal Health PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55154-6264_ee578124-e113-4a69-8edd-550c2196e3b5 55154-6264 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20121025 ANDA ANDA070920 Cardinal Health TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-6265_ee578124-e113-4a69-8edd-550c2196e3b5 55154-6265 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20121025 ANDA ANDA070920 Cardinal Health TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-6268_39396692-2b28-48ad-9d8b-607876093eda 55154-6268 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20130208 ANDA ANDA077042 Cardinal Health CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-6269_39396692-2b28-48ad-9d8b-607876093eda 55154-6269 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20130208 ANDA ANDA077042 Cardinal Health CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-6270_f51b917b-be32-4209-9d9a-f410fb025241 55154-6270 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20090903 ANDA ANDA070317 Cardinal Health CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55154-6271_3862232b-7606-4c51-bcec-19a7dabff4ec 55154-6271 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19810827 NDA NDA018487 Cardinal Health FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-6272_ce107475-667d-4d6f-8bd9-86f2f66edba3 55154-6272 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20120905 ANDA ANDA070278 Cardinal Health HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] 55154-6273_ce107475-667d-4d6f-8bd9-86f2f66edba3 55154-6273 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20120905 ANDA ANDA070278 Cardinal Health HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] 55154-6275_3862232b-7606-4c51-bcec-19a7dabff4ec 55154-6275 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19810827 NDA NDA018487 Cardinal Health FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-6276_d13bb5d7-0470-417b-a518-c09533ebc4c3 55154-6276 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20121005 ANDA ANDA076071 Cardinal Health LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-6277_d13bb5d7-0470-417b-a518-c09533ebc4c3 55154-6277 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20121005 ANDA ANDA076071 Cardinal Health LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-6278_ed8f5fec-04de-4191-b88b-4b8f7657bb9d 55154-6278 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA077665 Cardinal Health CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 55154-6279_39396692-2b28-48ad-9d8b-607876093eda 55154-6279 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20130208 ANDA ANDA077042 Cardinal Health CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-6280_3862232b-7606-4c51-bcec-19a7dabff4ec 55154-6280 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19870827 ANDA ANDA070082 Cardinal Health FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-6281_d13bb5d7-0470-417b-a518-c09533ebc4c3 55154-6281 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20121005 ANDA ANDA076071 Cardinal Health LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-6282_d13bb5d7-0470-417b-a518-c09533ebc4c3 55154-6282 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA076071 Cardinal Health LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-6284_cbecdd8c-30c0-49a7-9c0e-ccf5088426c4 55154-6284 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20061110 ANDA ANDA076702 Cardinal Health OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-6285_d13bb5d7-0470-417b-a518-c09533ebc4c3 55154-6285 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20121005 ANDA ANDA076071 Cardinal Health LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-6288_ce107475-667d-4d6f-8bd9-86f2f66edba3 55154-6288 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20120905 ANDA ANDA070278 Cardinal Health HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] 55154-6289_ce107475-667d-4d6f-8bd9-86f2f66edba3 55154-6289 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19860610 ANDA ANDA070278 Cardinal Health HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 55154-6292_aabc9548-b825-4a95-bbfc-95cfd8ebbecc 55154-6292 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130422 ANDA ANDA076704 Cardinal Health METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-6293_cec2eb26-8f9c-4266-885d-af8443d412de 55154-6293 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 Cardinal Health ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 55154-6294_aabc9548-b825-4a95-bbfc-95cfd8ebbecc 55154-6294 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130422 ANDA ANDA076704 Cardinal Health METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-6295_d3628f05-bdbe-4530-a99b-ea4a23f86f83 55154-6295 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron TABLET, FILM COATED ORAL 20121205 ANDA ANDA076930 Cardinal Health ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-6296_c5d272d4-e10d-4a0e-81d1-59285b8b3e25 55154-6296 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20121214 ANDA ANDA075973 Cardinal Health METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 55154-6297_5c489bcd-70b2-470c-a1df-cb0202fa8b94 55154-6297 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20090903 ANDA ANDA070317 Cardinal Health CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55154-6298_4bfb5698-477c-4973-8bad-391991fbf89a 55154-6298 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130520 ANDA ANDA076644 Cardinal Health OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-6328_0d008651-e2b5-4b48-a5f3-60f70bb3766a 55154-6328 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831130 ANDA ANDA018413 Cardinal Health FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-6330_0d008651-e2b5-4b48-a5f3-60f70bb3766a 55154-6330 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831130 ANDA ANDA018413 Cardinal Health FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-6334_6567dfb0-b220-40ea-9c00-551f873ffcf2 55154-6334 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20091106 ANDA ANDA075165 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55154-6342_e0a36a4d-a743-4067-9d51-f11c1bc96b09 55154-6342 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20091109 ANDA ANDA071321 Cardinal Health DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-6343_067a2094-f046-4cae-a1ea-8acb713deefc 55154-6343 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19820101 ANDA ANDA083177 Cardinal Health HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55154-6344_e0a36a4d-a743-4067-9d51-f11c1bc96b09 55154-6344 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20091109 ANDA ANDA071322 Cardinal Health DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-6349_b5580eb5-2f1c-44fb-aca6-138b872f249f 55154-6349 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED ORAL 20100901 ANDA ANDA065110 Cardinal Health CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 55154-6475_f5a1ddea-6a30-43fc-9952-ce17f4e4ce2e 55154-6475 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110926 ANDA ANDA077319 Cardinal Health LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-6526_a3c605f4-2b91-4148-9219-e38d3e01f93f 55154-6526 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE, COATED ORAL 20010314 ANDA ANDA065028 Cardinal Health RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 55154-6575_0c545593-e771-4f29-bcb1-fc0455146ac3 55154-6575 HUMAN PRESCRIPTION DRUG Ancobon flucytosine CAPSULE ORAL 19820101 NDA NDA017001 Cardinal Health FLUCYTOSINE 500 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] 55154-6625_a15f62e4-fa53-4235-a719-6f099d9b7927 55154-6625 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130626 ANDA ANDA040148 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-6626_2a850feb-e26f-4cb5-8653-336bd15f8bfc 55154-6626 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110401 ANDA ANDA075350 Cardinal Health GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-6627_852397de-2bc9-457c-b3a6-52816661ac15 55154-6627 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20130705 ANDA ANDA077397 Cardinal Health SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-6628_2aa5572a-809c-491a-9a58-3aa2b0c4ddde 55154-6628 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100910 ANDA ANDA086242 Cardinal Health HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-6629_818d8158-f365-4047-9305-f822691e31ae 55154-6629 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20101007 ANDA ANDA078938 Cardinal Health TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55154-6630_275a8e6f-2cbf-46c3-96d7-9204da74b493 55154-6630 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20050922 ANDA ANDA078402 Cardinal Health LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-6631_852397de-2bc9-457c-b3a6-52816661ac15 55154-6631 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20130705 ANDA ANDA077397 Cardinal Health SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-6637_b2a3c16b-cf37-42c1-bf20-2e679767a2ab 55154-6637 HUMAN PRESCRIPTION DRUG Divalproex Sodium DR Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20091014 ANDA ANDA078790 Cardinal Health DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-6638_275a8e6f-2cbf-46c3-96d7-9204da74b493 55154-6638 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20050922 ANDA ANDA078402 Cardinal Health LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-6639_852397de-2bc9-457c-b3a6-52816661ac15 55154-6639 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20101215 ANDA ANDA077397 Cardinal Health SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-6640_e8f18883-72aa-4b54-a9f6-512f3bfef570 55154-6640 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20110519 ANDA ANDA077584 Cardinal Health PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-6641_bbc090c8-ff9e-42a2-bc1a-bd60bd2b5b7a 55154-6641 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20110308 ANDA ANDA075133 Cardinal Health LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-6642_6a56110d-49e7-4734-8d52-3e39f09e01a9 55154-6642 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20091105 NDA NDA019594 Cardinal Health URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 55154-6643_8b08401f-fc1b-4e9e-9962-598a8e0f37be 55154-6643 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20130613 ANDA ANDA078243 Cardinal Health LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-6644_8f59b47f-c762-42f2-9700-89d5618154bb 55154-6644 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20080703 ANDA ANDA077614 Cardinal Health CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 55154-6645_8ca0f1ab-6ab0-4e4b-b360-59bb770b6799 55154-6645 HUMAN PRESCRIPTION DRUG Fludrocortisone Acetate Fludrocortisone Acetate TABLET ORAL 20080509 ANDA ANDA040431 Cardinal Health FLUDROCORTISONE ACETATE .1 mg/1 55154-6647_ffdfdd0a-d85c-43b0-baf4-3245bf512e90 55154-6647 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 20100113 ANDA ANDA075079 Cardinal Health OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-6648_5ee01875-ac25-4ee1-8771-ec2f6c54dbec 55154-6648 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20091207 ANDA ANDA075576 Cardinal Health OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55154-6649_e390c1b3-f50a-41c2-b938-8fa077b51028 55154-6649 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20130701 ANDA ANDA090432 Cardinal Health ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-6658_f1977b44-59b9-4e5e-802f-d201ef5c8783 55154-6658 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA077884 Cardinal Health ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55154-6659_f1977b44-59b9-4e5e-802f-d201ef5c8783 55154-6659 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA077884 Cardinal Health ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55154-6660_001714c1-a292-40be-bfbd-0ff67193ace6 55154-6660 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide citalopram hydrobromide TABLET, FILM COATED ORAL 20041124 ANDA ANDA077046 Cardinal Health CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-6661_001714c1-a292-40be-bfbd-0ff67193ace6 55154-6661 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide citalopram hydrobromide TABLET, FILM COATED ORAL 20041124 ANDA ANDA077046 Cardinal Health CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-6662_4963034a-3667-472e-97e9-5e07db32b68f 55154-6662 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 19990610 ANDA ANDA075191 Cardinal Health PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 55154-6664_94411cd4-5bb2-423f-ab5f-9685b5f1444c 55154-6664 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071196 Cardinal Health TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 55154-6666_cac0686d-d7fa-4bdf-8a0d-c653a5b2d136 55154-6666 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051007 ANDA ANDA065226 Cardinal Health CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-6668_8723966e-1227-451c-8b24-1b0c9275c154 55154-6668 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120420 ANDA ANDA065226 Cardinal Health CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-6669_930c984e-d59f-4a91-9a59-40e2610e6475 55154-6669 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Cardinal Health GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-6670_930c984e-d59f-4a91-9a59-40e2610e6475 55154-6670 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Cardinal Health GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-6671_b2076256-b139-4e39-b4f4-85886069d995 55154-6671 HUMAN PRESCRIPTION DRUG cilostazol cilostazol TABLET ORAL 20111018 ANDA ANDA077030 Cardinal Health CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 55154-6704_9c07a682-beaf-46a1-8e25-a8808d59a0a8 55154-6704 HUMAN OTC DRUG Bisacodyl Bisacodyl SUPPOSITORY RECTAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health BISACODYL 10 mg/1 55154-6705_978dd69b-c349-485b-bdf3-672b97890dcc 55154-6705 HUMAN OTC DRUG Bisacodyl Bisacodyl TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health BISACODYL 5 mg/1 55154-6707_2f2b4c63-d3b8-4ac3-a3bf-20c49cbe5262 55154-6707 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20060524 ANDA ANDA077893 Cardinal Health POLYETHYLENE GLYCOL 3350 17 g/1 Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 55154-6725_14f836ac-1abb-4faa-b35b-4bfef52bf17b 55154-6725 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20120930 NDA NDA020405 Cardinal Health DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 55154-6726_726b23ff-eb9a-4767-99ec-e1b228fabb95 55154-6726 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20120930 NDA NDA020405 Cardinal Health DIGOXIN .25 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 55154-6752_2fff2477-e216-4dd2-ab81-a9a34671c54b 55154-6752 HUMAN OTC DRUG Childrens Aspirin Aspirin TABLET, CHEWABLE ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Helath ASPIRIN 81 mg/1 55154-6754_f7c88834-aa7c-4aaa-ab9b-0cbcd1f4da3f 55154-6754 HUMAN OTC DRUG Sodium Bicarbonate Sodium Bicarbonate TABLET ORAL 20110606 UNAPPROVED DRUG OTHER Cardinal Health SODIUM BICARBONATE 650 mg/1 55154-6755_a5acfc6f-ffbc-4c85-8773-3a80ef43f1d7 55154-6755 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health ASPIRIN 325 mg/1 55154-6775_fcab4c61-9bfd-40ad-8389-65e077abd787 55154-6775 HUMAN PRESCRIPTION DRUG COLAZAL balsalazide disodium CAPSULE ORAL 20000718 NDA NDA020610 Cardinal Health BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 55154-6809_f9d457d2-6714-4141-be0b-376c85ce10ee 55154-6809 HUMAN OTC DRUG Calgest Calgest TABLET ORAL 19960123 OTC MONOGRAPH FINAL part331 Cardinal Health CALCIUM CARBONATE 500 mg/1 55154-6812_44c81163-4cdc-4399-9dd0-3e5febf987fc 55154-6812 HUMAN OTC DRUG EXTRA STRENGTH STOOL SOFTENER LAXATIVE DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120329 OTC MONOGRAPH NOT FINAL part334 Cardinal Health DOCUSATE SODIUM 250 mg/1 55154-6814_8fe72252-5258-4406-a985-c0875321f27c 55154-6814 HUMAN OTC DRUG Pain and Fever ACETAMINOPHEN TABLET ORAL 20110223 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 325 mg/1 55154-6815_a13d04f1-ee16-4733-b379-eb61ef3c0d09 55154-6815 HUMAN OTC DRUG Sodium Bicarbonate Antacid Sodium Bicarbonate TABLET ORAL 20100308 OTC MONOGRAPH FINAL part331 Cardinal Health SODIUM BICARBONATE 650 mg/1 55154-6816_0ad63931-f437-4478-bf96-b8c8cf802f7c 55154-6816 HUMAN OTC DRUG SENEXON-S DOCUSATE SODIUM -SENNOSIDES TABLET, COATED ORAL 20110316 OTC MONOGRAPH NOT FINAL part334 Cardinal Health DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 55154-6825_3fc428dc-47a0-4997-8b32-e68bfd4f6ca1 55154-6825 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110725 ANDA ANDA078010 Cardinal Health FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55154-6826_27ffb185-0ea7-4a9d-9e91-d525b27d018c 55154-6826 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20090617 ANDA ANDA075682 Cardinal Health IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-6827_03724ae5-e53b-4922-be81-33fa3ce570e8 55154-6827 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20070806 ANDA ANDA063083 Cardinal Health CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 55154-6828_3720a2da-0a05-4aa6-ae5c-a0463f15bd44 55154-6828 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength Aspirin TABLET, DELAYED RELEASE ORAL 20130628 OTC MONOGRAPH FINAL part343 Cardinal Health ASPIRIN 325 mg/3251 55154-6829_8209388a-ccde-48bd-bb3f-40b1ee3088df 55154-6829 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20100901 ANDA ANDA078916 Cardinal Health FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55154-6830_d57044c1-9222-4127-a491-3328324fb4b2 55154-6830 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20111101 ANDA ANDA079107 Cardinal Health LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-6831_9ed114aa-92cb-4d86-9c2b-8aefee4696c7 55154-6831 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20070801 ANDA ANDA074869 Cardinal Health CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-6834_280e5dba-3d71-4449-95d6-21222e2966a4 55154-6834 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110317 ANDA ANDA078374 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 55154-6835_45477ea2-09eb-4d9c-971e-bc1349132e1f 55154-6835 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Cardinal Health IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-6875_a74239bf-4684-424c-ba4e-6087e363265b 55154-6875 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20130120 ANDA ANDA078226 Cardinal Health AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55154-6876_9dcc7c11-9a7a-4a2d-b368-2fc52079e14e 55154-6876 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA201001 Cardinal Health DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55154-6877_1f88e909-ef24-452a-a34a-edc8bd65e8ea 55154-6877 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET ORAL 20090610 ANDA ANDA075133 Cardinal Health LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-6878_6a25e6d5-d2be-4121-adb2-3fe43d3a607f 55154-6878 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Cardinal Health OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 55154-6879_a204066f-d161-4c81-aa19-6e674599c1ba 55154-6879 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20040304 ANDA ANDA071972 Cardinal Health PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-6881_38a89689-efc2-4931-8f65-868dc0248d6a 55154-6881 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Cardinal Health OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 55154-6909_bb3580b7-14aa-44ae-9c69-1aee59b92c1c 55154-6909 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Cardinal Health QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 55154-6910_bb3580b7-14aa-44ae-9c69-1aee59b92c1c 55154-6910 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Cardinal Health QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 55154-6918_bb3580b7-14aa-44ae-9c69-1aee59b92c1c 55154-6918 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Cardinal Health QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 55154-6920_bb3580b7-14aa-44ae-9c69-1aee59b92c1c 55154-6920 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Cardinal Health QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 55154-6921_7db77f6b-5788-4f79-8990-63357d1c92f9 55154-6921 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA021366 Cardinal Health ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-6922_04450191-364a-4d88-98a4-4339424ff06f 55154-6922 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA021366 Cardinal Health ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-6922_4559c5e1-3733-4c5e-9175-e1e638d87727 55154-6922 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA021366 Cardinal Health ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-6923_4559c5e1-3733-4c5e-9175-e1e638d87727 55154-6923 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA021366 Cardinal Health ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-6924_4559c5e1-3733-4c5e-9175-e1e638d87727 55154-6924 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA021366 Cardinal Health ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-6925_4559c5e1-3733-4c5e-9175-e1e638d87727 55154-6925 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA021366 Cardinal Health ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-6926_22821abe-38fb-479f-8087-6de8705a0786 55154-6926 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA021366 Cardinal Health ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-6950_edeb0556-0643-4693-9779-7d5dda8b4062 55154-6950 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine lidocaine hydrochloride anhydrous and epinephrine INJECTION, SOLUTION INFILTRATION 20100405 ANDA ANDA089646 Cardinal Health EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 10; 20 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-6954_e3485086-7a10-45fa-aa83-ee6fbbf39c59 55154-6954 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050503 ANDA ANDA065204 Cardinal Health CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-6955_701c3b61-dc2c-4de6-9a85-d4ab93b33a3d 55154-6955 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20100618 NDA NDA021906 Cardinal Health LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA] 55154-6956_cb52fd1e-2ddf-4f45-b5c3-3d56b907270e 55154-6956 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050503 ANDA ANDA065204 Cardinal Health CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-6957_392fc0f1-b910-4d97-9b6d-00e1b2bc9d78 55154-6957 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050503 ANDA ANDA065204 Cardinal Health CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-6958_d4ff7c80-f38f-484e-8c95-2fb322500530 55154-6958 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Cardinal Health CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-6959_e519a5ae-4294-46a2-a58f-3027a605a5ef 55154-6959 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 20100107 ANDA ANDA070584 Cardinal Health BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 55154-6960_c9f994ab-ea02-4689-ae4d-eb11fa6035db 55154-6960 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110727 ANDA ANDA074802 Cardinal Health KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-6961_ef16311d-2e90-44fa-925e-ee60de8d39a4 55154-6961 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110908 NDA NDA018803 Cardinal Health SODIUM CHLORIDE 9 mg/mL 55154-6962_471fde4e-1661-4ca0-9d3e-18522139687a 55154-6962 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Cardinal Health CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-6963_681873b7-e7b3-4cbb-962a-107fa5cc7ebb 55154-6963 HUMAN PRESCRIPTION DRUG Diazepam Diazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19881220 ANDA ANDA072079 Cardinal Health DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-6964_0bd02665-6ce2-4736-8386-ca9d76b7bc66 55154-6964 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA088327 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-6965_553240ad-2b80-4ab4-b229-8eaf5e755a84 55154-6965 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN Base Filmtab ERYTHROMYCIN TABLET, FILM COATED ORAL 20110908 ANDA ANDA061621 Cardinal Health ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55154-6966_2c89e2a0-b0c8-4118-a777-74d97a1eda29 55154-6966 HUMAN PRESCRIPTION DRUG TRICOR fenofibrate TABLET ORAL 20041105 NDA NDA021656 Cardinal Health FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 55154-6967_2c89e2a0-b0c8-4118-a777-74d97a1eda29 55154-6967 HUMAN PRESCRIPTION DRUG TRICOR fenofibrate TABLET ORAL 20041105 NDA NDA021656 Cardinal Health FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 55154-6969_85140f60-eb70-4b1e-970f-64e66666db43 55154-6969 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA088327 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-6970_e519a5ae-4294-46a2-a58f-3027a605a5ef 55154-6970 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 20100106 ANDA ANDA070583 Cardinal Health BUPIVACAINE HYDROCHLORIDE ANHYDROUS 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 55154-6971_d29c37d8-cb3d-4bf8-9274-02b840295484 55154-6971 HUMAN PRESCRIPTION DRUG ZEMPLAR paricalcitol CAPSULE, LIQUID FILLED ORAL 20050526 NDA NDA021606 Cardinal Health PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 55154-6973_0bd02665-6ce2-4736-8386-ca9d76b7bc66 55154-6973 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA088299 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-6976_14e63aba-c1ce-4603-9db1-7e3411ee3cc3 55154-6976 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077548 Cardinal Health ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-6977_afe4e433-46ae-4482-86fb-03841ed84009 55154-6977 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 20110629 NDA NDA019445 Cardinal Health DEXTROSE MONOHYDRATE 25 g/50mL 55154-6978_77fd6ee4-108f-4525-8df5-7db9236042ee 55154-6978 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine lidocaine hydrochloride anhydrous and epinephrine INJECTION, SOLUTION INFILTRATION 20100405 ANDA ANDA089646 Cardinal Health EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 10; 20 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-6979_658b1a85-19ff-4034-990b-c6a4ab246dbb 55154-6979 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110908 NDA NDA018803 Cardinal Health SODIUM CHLORIDE 9 mg/mL 55154-6980_645a149e-9f57-4bc0-9ea2-b5fc72bd1c5d 55154-6980 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110708 ANDA ANDA070256 Cardinal Health NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 55154-6981_910cb308-36c6-4330-8f25-45998ec3cde7 55154-6981 HUMAN PRESCRIPTION DRUG Atropine Sulfate ATROPINE SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20051025 UNAPPROVED DRUG OTHER Cardinal Health ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55154-6982_0c27c868-7eae-4b3e-babf-e89404ea27b7 55154-6982 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110325 ANDA ANDA070737 Cardinal Health VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-6983_afd7c91b-3283-49e7-b79f-1c8d0c1a53bd 55154-6983 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA088325 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-6984_afd7c91b-3283-49e7-b79f-1c8d0c1a53bd 55154-6984 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA088328 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-6985_a152ec6a-6e7a-4152-8db5-7ee81e11ca07 55154-6985 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20090831 ANDA ANDA090571 Cardinal Health HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 55154-6986_a70a9886-743e-487c-883a-aaeebb62e0e8 55154-6986 HUMAN PRESCRIPTION DRUG Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110708 ANDA ANDA089069 Cardinal Health PROCAINAMIDE HYDROCHLORIDE 100 mg/mL Antiarrhythmic [EPC] 55154-6987_53eaa46e-6b65-4e39-8535-0a072bb38e4d 55154-6987 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline Dihydrate INJECTION, SOLUTION INTRAVENOUS 20110211 ANDA ANDA087242 Cardinal Health AMINOPHYLLINE DIHYDRATE 25 mg/mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 55154-6988_20062322-f9db-4c9b-9da2-7608468f62c9 55154-6988 HUMAN PRESCRIPTION DRUG Isuprel ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20120618 NDA NDA010515 Cardinal Health ISOPROTERENOL HYDROCHLORIDE .2 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] 55154-6989_a152ec6a-6e7a-4152-8db5-7ee81e11ca07 55154-6989 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20090831 ANDA ANDA090571 Cardinal Health HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 55154-6990_9a411099-cc7c-4973-be22-271fbfae342f 55154-6990 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110325 ANDA ANDA070737 Cardinal Health VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55154-6991_2b82d876-3c8d-43ed-b25c-004e84d6fbd0 55154-6991 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 20100106 ANDA ANDA070583 Cardinal Health BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 55154-6992_afd7c91b-3283-49e7-b79f-1c8d0c1a53bd 55154-6992 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA088327 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-6994_e93eda9e-a45e-42b0-afde-22b4f350efd5 55154-6994 HUMAN PRESCRIPTION DRUG Diazepam DIAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19871013 ANDA ANDA071583 Cardinal Health DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-6995_4656a98c-f339-4144-b30a-3bb2168eb342 55154-6995 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 19850418 UNAPPROVED DRUG OTHER Cardinal Health SODIUM BICARBONATE 84 mg/mL 55154-6996_0666ae92-0a62-41e2-a3e0-67b83e2889b5 55154-6996 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20050131 ANDA ANDA088100 Cardinal Health HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 55154-6997_506c80c2-5054-4ccd-b389-d0b159a9216c 55154-6997 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020613 ANDA ANDA075856 Cardinal Health MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-6998_352a5aa0-3595-4b4f-bf71-9d4d7f721719 55154-6998 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20120306 ANDA ANDA070172 Cardinal Health NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 55154-6999_c7bd63ec-452c-4ddc-9327-21aad5216fe4 55154-6999 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE INJECTION INTRAVENOUS 19720316 ANDA ANDA080205 Cardinal Health POTASSIUM CHLORIDE 149 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55154-7025_973393be-e9d0-4cee-a5f3-85f33c3c5f34 55154-7025 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20130617 ANDA ANDA202297 Cardinal Health CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55154-7175_c5a77c6b-db9a-495a-bfb2-8e48e27b23c2 55154-7175 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Cardinal Health DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-7201_867433f1-932a-4b71-a2ff-88d6e6c428cf 55154-7201 HUMAN PRESCRIPTION DRUG Lortab Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20110113 ANDA ANDA089699 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-7202_bf4631fb-5ed9-4c21-92a6-c0e5f800bbae 55154-7202 HUMAN PRESCRIPTION DRUG Lortab Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19960126 ANDA ANDA040100 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-7204_b990f540-a718-49de-98df-95c5a7d07e6f 55154-7204 HUMAN PRESCRIPTION DRUG LORTAB Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19820709 ANDA ANDA087722 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-7206_f24f8e9c-ac46-4101-9250-9005af0edf72 55154-7206 HUMAN PRESCRIPTION DRUG Theo-24 theophylline, anhydrous CAPSULE, EXTENDED RELEASE ORAL 19830822 ANDA ANDA087944 Cardinal Health THEOPHYLLINE ANHYDROUS 300 mg/1 55154-7211_90b553fe-4e94-4cce-b5df-ea3e6487930d 55154-7211 HUMAN PRESCRIPTION DRUG KEPPRA levetiracetam INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060731 NDA NDA021872 Cardinal Health LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-7257_dad4bbdd-4669-4656-a469-a8a1849d8bcb 55154-7257 HUMAN PRESCRIPTION DRUG RESTORIL temazepam CAPSULE ORAL 20081120 NDA NDA018163 Cardinal Health TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-7261_9b0ad1b1-d566-4f77-b02e-310624990d99 55154-7261 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040405 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-7269_1b190f46-8b18-4a3b-8f1b-9289103b6fe7 55154-7269 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040409 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-7270_1b190f46-8b18-4a3b-8f1b-9289103b6fe7 55154-7270 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 20160731 ANDA ANDA089160 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-7271_1b190f46-8b18-4a3b-8f1b-9289103b6fe7 55154-7271 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040405 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-7272_1b190f46-8b18-4a3b-8f1b-9289103b6fe7 55154-7272 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 20170731 ANDA ANDA040201 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-7273_1b190f46-8b18-4a3b-8f1b-9289103b6fe7 55154-7273 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040400 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-7274_1b190f46-8b18-4a3b-8f1b-9289103b6fe7 55154-7274 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 20150831 ANDA ANDA040201 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-7301_353c0141-8e9a-45b6-b8ad-3113db8c0d2e 55154-7301 HUMAN PRESCRIPTION DRUG Lorcet Hydrocodone bitartrate and Acetaminophen TABLET ORAL 19920529 ANDA ANDA081223 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-7302_fa700965-112d-4907-9e08-8c57f5c90b4a 55154-7302 HUMAN PRESCRIPTION DRUG Lorcet Plus Hydrocodone bitartrate and Acetaminophen TABLET ORAL 19880629 ANDA ANDA089689 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-7352_2c744bba-0537-467d-b6d9-9b9b7f922f6e 55154-7352 HUMAN OTC DRUG Oracit Oral Citrate LIQUID ORAL 20110607 UNAPPROVED DRUG OTHER Cardinal Health CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 490; 640 mg/5mL; mg/5mL 55154-7353_3c3b02a3-9a75-40a5-889d-97318faf881f 55154-7353 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate sodium polystyrene sulfonate SUSPENSION ORAL; RECTAL 19830101 ANDA ANDA087859 Cardinal Health SODIUM POLYSTYRENE SULFONATE 15 g/60mL 55154-7452_3b9e0411-1dc7-418c-b0d3-fa4661efe868 55154-7452 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 19950612 ANDA ANDA089718 Cardinal Health ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 55154-7453_2c996dee-ecf4-4cf4-bd50-af37bcded796 55154-7453 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 19820101 ANDA ANDA080154 Cardinal Health PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 55154-7456_37783937-1d47-4464-8744-d92216869ea1 55154-7456 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20030617 ANDA ANDA076490 Cardinal Health LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] 55154-7457_5a0030aa-bfd4-4f22-9c1f-b6db16f25ec5 55154-7457 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20000101 UNAPPROVED DRUG OTHER Cardinal Health PHENOBARBITAL 60 mg/1 CIV 55154-7458_5a0030aa-bfd4-4f22-9c1f-b6db16f25ec5 55154-7458 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20000101 UNAPPROVED DRUG OTHER Cardinal Health PHENOBARBITAL 30 mg/1 CIV 55154-7460_3cafc0f0-0606-49d7-91ae-48f39084a880 55154-7460 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 20070530 ANDA ANDA077761 Cardinal Health METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-7461_7317e374-847a-4b8a-851d-467a0bb9c77e 55154-7461 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION INTRAVENOUS 20061001 ANDA ANDA040573 Cardinal Health PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-7463_5d82f215-15e3-4156-98a8-8b7aed19bea3 55154-7463 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION INTRAMUSCULAR; INTRAVENOUS 20010918 ANDA ANDA065047 Cardinal Health CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-7464_7317e374-847a-4b8a-851d-467a0bb9c77e 55154-7464 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin INJECTION INTRAVENOUS 20061001 ANDA ANDA040573 Cardinal Health PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-7465_3682944d-b409-461b-9808-52fa1a8f331b 55154-7465 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060330 ANDA ANDA076813 Cardinal Health ISOSORBIDE MONONITRATE 30 mg/1 55154-7466_3682944d-b409-461b-9808-52fa1a8f331b 55154-7466 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060330 ANDA ANDA076813 Cardinal Health ISOSORBIDE MONONITRATE 60 mg/1 55154-7467_5a0030aa-bfd4-4f22-9c1f-b6db16f25ec5 55154-7467 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20000101 UNAPPROVED DRUG OTHER Cardinal Health PHENOBARBITAL 15 mg/1 CIV 55154-7468_250317a2-dd96-4e44-9806-4f32c8808efd 55154-7468 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 19871029 ANDA ANDA086066 Cardinal Health ISOSORBIDE DINITRATE 10 mg/1 55154-7469_2d270d6b-d2f2-4017-b275-65ed166512a1 55154-7469 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 Cardinal Health DOXYCYCLINE HYCLATE 100 mg/1 55154-7470_250317a2-dd96-4e44-9806-4f32c8808efd 55154-7470 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 19871029 ANDA ANDA086066 Cardinal Health ISOSORBIDE DINITRATE 20 mg/1 55154-7474_e6237019-490f-4162-bfe0-6e2d08c0a1be 55154-7474 HUMAN PRESCRIPTION DRUG Flumazenil flumazenil INJECTION, SOLUTION INTRAVENOUS 20070101 ANDA ANDA078527 Cardinal Health FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 55154-7475_65688bed-0d70-4b51-8301-1948b1deade1 55154-7475 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20110921 ANDA ANDA090963 Cardinal Health GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 55154-7552_10570b57-f003-402c-a95e-c4e7199fc8cf 55154-7552 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100507 ANDA ANDA075511 Cardinal Health FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55154-7552_8c37a1eb-2541-4381-be72-e757913a3f78 55154-7552 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100507 ANDA ANDA075511 Cardinal Health FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55154-7553_0ea9d685-85e0-44a8-a864-ee849b1a7998 55154-7553 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20090629 ANDA ANDA040419 Cardinal Health ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 55154-7554_e34af813-d00d-441f-a4b2-c646514da74e 55154-7554 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040400 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-7555_e34af813-d00d-441f-a4b2-c646514da74e 55154-7555 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040409 Cardinal Health ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 55154-7559_6d3a6f36-28bd-4b74-a594-927f093b5d3f 55154-7559 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20110101 ANDA ANDA074787 Cardinal Health LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-7560_6d3a6f36-28bd-4b74-a594-927f093b5d3f 55154-7560 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20110101 ANDA ANDA074787 Cardinal Health LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-7566_774af6ea-3aa9-47e2-8b29-723f8a310c53 55154-7566 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20101201 ANDA ANDA076077 Cardinal Health FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55154-7652_9ceb7773-dc98-40ec-be12-469b4d517dda 55154-7652 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20080111 ANDA ANDA078069 Cardinal Health OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-7676_9cde8725-a403-4ce1-85e3-f5634636b5fc 55154-7676 HUMAN PRESCRIPTION DRUG Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate TABLET ORAL 20120628 UNAPPROVED DRUG OTHER Cardinal Health POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 155; 852; 130 mg/1; mg/1; mg/1 55154-7701_b5af564d-915d-4868-ba01-e18123cd984f 55154-7701 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Cardinal Health WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-7702_b5af564d-915d-4868-ba01-e18123cd984f 55154-7702 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Cardinal Health WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-7703_b5af564d-915d-4868-ba01-e18123cd984f 55154-7703 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Cardinal Health WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-7704_b5af564d-915d-4868-ba01-e18123cd984f 55154-7704 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Cardinal Health WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-7706_b5af564d-915d-4868-ba01-e18123cd984f 55154-7706 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Cardinal Health WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-7707_b5af564d-915d-4868-ba01-e18123cd984f 55154-7707 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Cardinal Health WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-7712_db8d5c93-7d59-4995-b388-d55ba90d6acb 55154-7712 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride and acetaminophen TABLET ORAL 19990630 ANDA ANDA040330 Cardinal Health ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55154-7716_b5af564d-915d-4868-ba01-e18123cd984f 55154-7716 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Cardinal Health WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-7717_b5af564d-915d-4868-ba01-e18123cd984f 55154-7717 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Cardinal Health WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55154-7750_d7038a81-a9b9-4cc0-aafb-14e8eb608360 55154-7750 HUMAN PRESCRIPTION DRUG phoslo Calcium Acetate CAPSULE ORAL 20010402 NDA NDA021160 Cardinal Health CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 55154-7776_5deaa86e-993d-4af9-9494-5a0de95e8291 55154-7776 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20090327 NDA NDA021282 Cardinal Health GUAIFENESIN 600 mg/1 55154-7777_e11fdf60-b204-4525-bab3-97091786c31e 55154-7777 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20100722 NDA NDA021282 Cardinal Health GUAIFENESIN 600 mg/1 55154-7801_5915b2bb-ae53-4781-91ed-ff90188fe1d8 55154-7801 HUMAN PRESCRIPTION DRUG Levoxyl levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Cardinal Health LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-7802_5915b2bb-ae53-4781-91ed-ff90188fe1d8 55154-7802 HUMAN PRESCRIPTION DRUG Levoxyl levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Cardinal Health LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-7803_5915b2bb-ae53-4781-91ed-ff90188fe1d8 55154-7803 HUMAN PRESCRIPTION DRUG Levoxyl levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Cardinal Health LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-7804_5915b2bb-ae53-4781-91ed-ff90188fe1d8 55154-7804 HUMAN PRESCRIPTION DRUG Levoxyl levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Cardinal Health LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-7805_5915b2bb-ae53-4781-91ed-ff90188fe1d8 55154-7805 HUMAN PRESCRIPTION DRUG Levoxyl levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Cardinal Health LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-7806_5915b2bb-ae53-4781-91ed-ff90188fe1d8 55154-7806 HUMAN PRESCRIPTION DRUG Levoxyl levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Cardinal Health LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-7807_5915b2bb-ae53-4781-91ed-ff90188fe1d8 55154-7807 HUMAN PRESCRIPTION DRUG Levoxyl levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Cardinal Health LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-7808_5915b2bb-ae53-4781-91ed-ff90188fe1d8 55154-7808 HUMAN PRESCRIPTION DRUG Levoxyl levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Cardinal Health LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-7809_5915b2bb-ae53-4781-91ed-ff90188fe1d8 55154-7809 HUMAN PRESCRIPTION DRUG Levoxyl levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Cardinal Health LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-7810_5915b2bb-ae53-4781-91ed-ff90188fe1d8 55154-7810 HUMAN PRESCRIPTION DRUG Levoxyl levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Cardinal Health LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-7811_5915b2bb-ae53-4781-91ed-ff90188fe1d8 55154-7811 HUMAN PRESCRIPTION DRUG Levoxyl levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Cardinal Health LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55154-7850_ba4f06c3-ebce-4896-a5cc-59bb5c2cb4e5 55154-7850 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940729 ANDA ANDA064067 Cardinal Health ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55154-8250_b358c1f1-044c-4dd5-a8e8-ef7800315104 55154-8250 HUMAN PRESCRIPTION DRUG BUDEPRION SR BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20040322 ANDA ANDA075913 Cardinal Health BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 55154-8251_d84912c1-d947-406f-9a8a-df1ff5517b2b 55154-8251 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20091029 ANDA ANDA075765 Cardinal Health CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 55154-8252_2253b585-ef8c-474f-9ee1-29624645aaff 55154-8252 HUMAN PRESCRIPTION DRUG Nystatin Nystatin TABLET, FILM COATED ORAL 19840116 ANDA ANDA062506 Cardinal Health NYSTATIN 500000 [USP'U]/1 Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 55154-8255_b358c1f1-044c-4dd5-a8e8-ef7800315104 55154-8255 HUMAN PRESCRIPTION DRUG BUDEPRION SR BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20040128 ANDA ANDA075913 Cardinal Health BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 55154-8257_8cdd6af4-7124-4ea5-b822-92b8edd3a442 55154-8257 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20101019 ANDA ANDA072801 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 55154-8258_0336960e-aebc-4eb8-8a6e-d60a80cd2709 55154-8258 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20100829 ANDA ANDA088628 Cardinal Health ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII 55154-8260_0336960e-aebc-4eb8-8a6e-d60a80cd2709 55154-8260 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20101007 ANDA ANDA088627 Cardinal Health ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 CIII 55154-8261_0336960e-aebc-4eb8-8a6e-d60a80cd2709 55154-8261 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20101007 ANDA ANDA088629 Cardinal Health ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 CIII 55154-8264_48a75305-ae2d-46e9-a63b-4bc1a95d90b4 55154-8264 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20100420 ANDA ANDA074754 Cardinal Health KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-8266_f715ced2-ff1c-43af-ac81-f113cb9d3f27 55154-8266 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110119 ANDA ANDA077048 Cardinal Health CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-8267_f715ced2-ff1c-43af-ac81-f113cb9d3f27 55154-8267 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110119 ANDA ANDA077048 Cardinal Health CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-8269_f715ced2-ff1c-43af-ac81-f113cb9d3f27 55154-8269 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110119 ANDA ANDA077048 Cardinal Health CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-8270_057a5305-f8a4-4f2a-88b5-501704fa3c11 55154-8270 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20100804 ANDA ANDA074388 Cardinal Health GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55154-8273_d895f039-acf5-4fac-9698-11b8bac45159 55154-8273 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20101213 ANDA ANDA074201 Cardinal Health NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-8274_361e8060-b977-4a40-a32b-7db04f256378 55154-8274 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20091222 ANDA ANDA076388 Cardinal Health LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-8275_361e8060-b977-4a40-a32b-7db04f256378 55154-8275 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20091222 ANDA ANDA076388 Cardinal Health LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-8277_cc16fdd6-d72c-4922-942b-7962fe8f361c 55154-8277 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20111118 ANDA ANDA061926 Cardinal Health AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55154-8278_cc16fdd6-d72c-4922-942b-7962fe8f361c 55154-8278 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20111118 ANDA ANDA061926 Cardinal Health AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55154-8279_8ba7933f-169e-42d4-8dfe-736f38070f29 55154-8279 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20100108 ANDA ANDA070848 Cardinal Health SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 55154-8281_d84912c1-d947-406f-9a8a-df1ff5517b2b 55154-8281 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20091029 ANDA ANDA075765 Cardinal Health CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 55154-8283_dff795fb-1949-469f-bc8c-e06787984451 55154-8283 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20091215 ANDA ANDA077519 Cardinal Health BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-8284_62c24698-93b9-44f4-bdc4-19737d2c5cc8 55154-8284 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20101214 ANDA ANDA075551 Cardinal Health LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-8285_94ca2fa4-e9c6-4fd1-9ec4-8ec70e36fa23 55154-8285 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20100212 ANDA ANDA074949 Cardinal Health CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] 55154-8286_c983c578-d6c4-46e3-aca6-56de081f07ab 55154-8286 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100602 ANDA ANDA077936 Cardinal Health MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-8287_8e49409b-6bb1-4b8a-8a5b-4cb1a291660e 55154-8287 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20110218 ANDA ANDA077027 Cardinal Health CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 55154-8289_8323edbd-906f-4189-a169-d575fa4784f1 55154-8289 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19920501 ANDA ANDA063011 Cardinal Health MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 55154-8294_51b79b76-9598-4490-b064-9c85ee2f18b2 55154-8294 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20111207 ANDA ANDA074578 Cardinal Health ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55154-8295_51b79b76-9598-4490-b064-9c85ee2f18b2 55154-8295 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970423 ANDA ANDA074556 Cardinal Health ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55154-8296_bbb92753-412a-4681-ac2b-6374396bfcef 55154-8296 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030129 ANDA ANDA076119 Cardinal Health MIRTAZAPINE 15 mg/1 55154-8297_bbb92753-412a-4681-ac2b-6374396bfcef 55154-8297 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030129 ANDA ANDA076119 Cardinal Health MIRTAZAPINE 30 mg/1 55154-8298_31cb83ae-4057-47bd-b696-240d5aad4aa7 55154-8298 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120217 ANDA ANDA077243 Cardinal Health OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 55154-8299_31cb83ae-4057-47bd-b696-240d5aad4aa7 55154-8299 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120217 ANDA ANDA077243 Cardinal Health OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 55154-8329_758b42d4-811e-4e30-823e-bcfd85800065 55154-8329 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121221 ANDA ANDA202600 Cardinal Health ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55154-8330_9c9b56de-9937-4269-9e02-de6364049362 55154-8330 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Cardinal Health MIRTAZAPINE 15 mg/1 55154-8331_9c9b56de-9937-4269-9e02-de6364049362 55154-8331 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Cardinal Health MIRTAZAPINE 30 mg/1 55154-8332_9c9b56de-9937-4269-9e02-de6364049362 55154-8332 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Cardinal Health MIRTAZAPINE 45 mg/1 55154-8333_9c9b56de-9937-4269-9e02-de6364049362 55154-8333 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Cardinal Health MIRTAZAPINE 7.5 mg/1 55154-8375_ba7dc1bd-b309-4032-8027-72605459433f 55154-8375 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060701 ANDA ANDA077944 Cardinal Health MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-8376_12873fc6-dd7c-4886-8c4c-259ae44e5848 55154-8376 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070201 ANDA ANDA077670 Cardinal Health SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-8377_12873fc6-dd7c-4886-8c4c-259ae44e5848 55154-8377 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070201 ANDA ANDA077670 Cardinal Health SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-8384_12873fc6-dd7c-4886-8c4c-259ae44e5848 55154-8384 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070201 ANDA ANDA077670 Cardinal Health SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55154-8385_d5108fbc-a163-4bbf-aed0-3b549875ab79 55154-8385 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Cardinal Health LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-8386_d5108fbc-a163-4bbf-aed0-3b549875ab79 55154-8386 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Cardinal Health LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-8387_d5108fbc-a163-4bbf-aed0-3b549875ab79 55154-8387 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Cardinal Health LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-8388_d5108fbc-a163-4bbf-aed0-3b549875ab79 55154-8388 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Cardinal Health LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-8389_d5108fbc-a163-4bbf-aed0-3b549875ab79 55154-8389 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Cardinal Health LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55154-8509_b918c688-5101-47e8-a318-21d66e765256 55154-8509 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 19970110 ANDA ANDA074755 Cardinal Health IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 55154-8606_f50b167c-9ed5-4c01-ab50-d8e823d53ad3 55154-8606 HUMAN OTC DRUG Simethicone Simethicone TABLET, CHEWABLE ORAL 20110603 UNAPPROVED DRUG OTHER Cardinal Health DIMETHICONE 80 mg/1 55154-8607_d26c22c9-64fb-4a20-993d-f5373dfb69d8 55154-8607 HUMAN PRESCRIPTION DRUG ASACOL mesalamine TABLET, DELAYED RELEASE ORAL 19920401 NDA NDA019651 Cardinal Health MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 55154-8705_23b73332-cbb3-4155-8ad8-b24619cdea85 55154-8705 HUMAN PRESCRIPTION DRUG Prograf Tacrolimus CAPSULE, GELATIN COATED ORAL 19940408 NDA NDA050708 Cardinal Health TACROLIMUS ANHYDROUS 1 mg/1 55154-8710_c512a67b-eb94-42f2-a436-143ffb064af8 55154-8710 HUMAN PRESCRIPTION DRUG Adenocard adenosine SOLUTION INTRAVENOUS 19891030 NDA NDA019937 Cardinal Health ADENOSINE 6 mg/2mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 55154-8711_45faaa70-54cf-4f82-bf7e-8bdd3865e1d6 55154-8711 HUMAN PRESCRIPTION DRUG Adenocard adenosine SOLUTION INTRAVENOUS 19891030 NDA NDA019937 Cardinal Health ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 55154-8850_f52aba3b-bedc-4baa-bcbe-4a01b37ce963 55154-8850 HUMAN OTC DRUG Acephen Acetaminophen SUPPOSITORY RECTAL 20110606 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 650 mg/1 55154-8851_7c861591-7163-41be-adb8-b9bdbdb9a230 55154-8851 HUMAN OTC DRUG Bisac-Evac Bisacodyl SUPPOSITORY RECTAL 20110606 UNAPPROVED DRUG OTHER Cardinal Health BISACODYL 10 mg/1 55154-9352_7b863404-4dbe-4840-acb1-73b267792c27 55154-9352 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION INTRAVENOUS 20000810 ANDA ANDA088912 Cardinal Health SODIUM CHLORIDE 9 mg/mL 55154-9354_6a477cf9-4117-455e-8919-efd791b18e12 55154-9354 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Cardinal Health HEPARIN SODIUM 5000 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 55154-9356_c95a55d2-68cc-4a55-a15c-c308ad8c43eb 55154-9356 HUMAN PRESCRIPTION DRUG Oxytocin OXYTOCIN INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000810 NDA NDA018248 Cardinal Health OXYTOCIN 10 [USP'U]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 55154-9357_97007188-43fe-416c-a87b-6ccc4d9ae2ec 55154-9357 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION INTRAVENOUS 20000810 ANDA ANDA088912 Cardinal Health SODIUM CHLORIDE 9 mg/mL 55154-9358_84881f58-e497-4c34-9c0c-d73595be81d2 55154-9358 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000808 NDA NDA019316 Cardinal Health MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 55154-9359_6a477cf9-4117-455e-8919-efd791b18e12 55154-9359 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Cardinal Health HEPARIN SODIUM 10000 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 55154-9360_6a477cf9-4117-455e-8919-efd791b18e12 55154-9360 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Cardinal Health HEPARIN SODIUM 1000 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 55154-9363_50df93bf-fe72-48f6-a02e-ea9a313d47c2 55154-9363 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20020528 ANDA ANDA040466 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 55154-9364_488e4954-1b84-465b-8879-7b0b0d442a37 55154-9364 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000907 ANDA ANDA084916 Cardinal Health DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-9365_1dd0d718-2ca7-4371-b726-5d67a2673fdf 55154-9365 HUMAN PRESCRIPTION DRUG Gentamicin GENTAMICIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000810 ANDA ANDA062366 Cardinal Health GENTAMICIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 55154-9367_c294ead9-aa25-4c76-85f4-fbfc5e6b72de 55154-9367 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride HYDRALAZINE HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20110131 ANDA ANDA040388 Cardinal Health HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-9368_f335a030-ffa8-4f42-8166-2f06e036b40d 55154-9368 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 20001018 ANDA ANDA075784 Cardinal Health KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-9370_3533f934-c8a2-4045-a499-c90eb3683c63 55154-9370 HUMAN PRESCRIPTION DRUG Calcium Gluconate CALCIUM GLUCONATE INJECTION, SOLUTION INTRAVENOUS 20000809 UNAPPROVED DRUG OTHER Cardinal Health CALCIUM GLUCONATE 94 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 55154-9371_bbd336f6-33ee-48b7-bec2-a3a445957b41 55154-9371 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20030529 ANDA ANDA040491 Cardinal Health DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-9372_b9509368-3d72-4051-a08e-81636f6318ca 55154-9372 HUMAN PRESCRIPTION DRUG Thiamine THIAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000901 ANDA ANDA080556 Cardinal Health THIAMINE HYDROCHLORIDE 100 mg/mL 55154-9373_6a477cf9-4117-455e-8919-efd791b18e12 55154-9373 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Cardinal Health HEPARIN SODIUM 1000 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 55154-9375_183ca97a-921c-456e-9db4-48f56069a059 55154-9375 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 20001018 ANDA ANDA075784 Cardinal Health KETOROLAC TROMETHAMINE 60 mg/2mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55154-9376_faa12ba9-072d-465e-9753-4ab4f1e3b6c6 55154-9376 HUMAN PRESCRIPTION DRUG Gentamicin GENTAMICIN INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041129 ANDA ANDA062366 Cardinal Health GENTAMICIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 55154-9377_32f56793-6197-4da4-8a98-7df0674ce2c5 55154-9377 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Cardinal Health HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 55154-9378_f0ca8550-6179-495a-98d1-e7858d24230f 55154-9378 HUMAN PRESCRIPTION DRUG Lidocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100527 ANDA ANDA080404 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-9379_553a0e06-8ef1-4edc-a81d-47662ec1a366 55154-9379 HUMAN PRESCRIPTION DRUG Ampicillin ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19870512 ANDA ANDA062719 Cardinal Health AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55154-9382_cce0cabf-1519-4ea4-92ba-638c8b36efac 55154-9382 HUMAN PRESCRIPTION DRUG Azithromycin AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20060320 ANDA ANDA065179 Cardinal Health AZITHROMYCIN MONOHYDRATE 500 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55154-9383_3858775b-61a0-4ef5-a944-0f4ffdf33779 55154-9383 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041130 ANDA ANDA040583 Cardinal Health METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-9384_553a0e06-8ef1-4edc-a81d-47662ec1a366 55154-9384 HUMAN PRESCRIPTION DRUG Ampicillin ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19930712 ANDA ANDA062797 Cardinal Health AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55154-9385_150cbd48-d550-42f4-bb35-131e0b47c5be 55154-9385 HUMAN PRESCRIPTION DRUG Azithromycin AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091210 ANDA ANDA065179 Cardinal Health AZITHROMYCIN MONOHYDRATE 100 mg/mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55154-9386_7b687747-bf51-4366-9277-29bc82fc665a 55154-9386 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN SODIUM,TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110531 ANDA ANDA065523 Cardinal Health PIPERACILLIN; TAZOBACTAM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 55154-9387_8d5b7fe8-a73a-4bf3-9319-6816af6df093 55154-9387 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000907 ANDA ANDA084916 Cardinal Health DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-9388_86d131f9-e25a-4731-a201-2b6d3e0a7974 55154-9388 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-9389_54c52410-ab99-48a9-becc-c65a4075705d 55154-9389 HUMAN PRESCRIPTION DRUG Imipenem and Cilastatin Imipenem and Cilastatin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120103 ANDA ANDA090577 Cardinal Health CILASTATIN SODIUM; IMIPENEM 500; 500 mg/1; mg/1 Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 55154-9390_09672124-12d2-48f0-af1f-d9ca048e5b53 55154-9390 HUMAN PRESCRIPTION DRUG Lidocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20000905 NDA NDA017584 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-9391_bc755638-8797-43ab-be0b-4ea3ded3f644 55154-9391 HUMAN PRESCRIPTION DRUG Protamine Sulfate PROTAMINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20001018 ANDA ANDA089454 Cardinal Health PROTAMINE SULFATE 10 mg/mL Heparin Binding Activity [MoA],Heparin Reversal Agent [EPC],Reversed Anticoagulation Activity [PE] 55154-9392_6a477cf9-4117-455e-8919-efd791b18e12 55154-9392 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Cardinal Health HEPARIN SODIUM 5000 [USP&apos'U]/.5mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 55154-9393_959203df-fea9-4af8-8168-d006828e589e 55154-9393 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 Cardinal Health MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-9394_5d8e2eca-8a3b-42ef-9e41-cd5c18ad8f97 55154-9394 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000808 UNAPPROVED DRUG OTHER Cardinal Health MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 55154-9395_a4d1d5b7-92b0-4448-a9b7-1d951e11d4f7 55154-9395 HUMAN PRESCRIPTION DRUG Bacteriostatic Sodium Chloride SODIUM CHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20000808 ANDA ANDA088911 Cardinal Health SODIUM CHLORIDE 9 mg/mL 55154-9396_1f80e4aa-232e-4110-b22f-3d29a9ff06ea 55154-9396 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-9397_238b1e77-8863-42c4-ac3c-51ddd710520d 55154-9397 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20090812 NDA NDA017029 Cardinal Health HEPARIN SODIUM 5000 [USP&apos'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 55154-9401_85cc6ce7-5874-446a-8d8c-90cddf474445 55154-9401 HUMAN OTC DRUG Docusate Sodium Docusate Sodium LIQUID ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health DOCUSATE SODIUM 100 mg/10mL 55154-9403_27007b04-51c8-416e-9a24-a390b5d4c267 55154-9403 HUMAN OTC DRUG Milk of Magnesia Milk of Magnesia SUSPENSION ORAL 20110607 UNAPPROVED DRUG OTHER Cardinal Health MAGNESIUM HYDROXIDE 2400 mg/30mL 55154-9405_e8ae69ec-8e86-4119-85b2-ab2a0a0145fb 55154-9405 HUMAN OTC DRUG Acetaminophen Oral Solution Acetaminophen LIQUID ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 650 mg/20.3mL 55154-9409_4bd9e2d7-61b2-4dd4-afe8-c1efe7c512d9 55154-9409 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride ELIXIR ORAL 19820210 ANDA ANDA087513 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/10mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 55154-9410_66240374-3ad4-4832-9f33-5462d22d1a97 55154-9410 HUMAN PRESCRIPTION DRUG Sodium Citrate and Citric Acid SODIUM CITRATE and CITRIC ACID MONOHYDRATE SOLUTION ORAL 19690101 UNAPPROVED DRUG OTHER Cardinal Health CITRIC ACID MONOHYDRATE; SODIUM CITRATE 334; 500 mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 55154-9412_9fc51c0d-56f9-4f5d-aa30-4af74075268c 55154-9412 HUMAN OTC DRUG Milk of Magnesia Milk of Magnesia SUSPENSION ORAL 20110607 UNAPPROVED DRUG OTHER Cardinal Health MAGNESIUM HYDROXIDE 2400 mg/10mL 55154-9415_f186718f-54e6-4163-a447-cae9cc7d3f41 55154-9415 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 20110610 ANDA ANDA087508 Cardinal Health ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 55154-9417_2b8a640c-6859-42b3-a5dc-7a7d2a12816c 55154-9417 HUMAN OTC DRUG Acetaminophen Oral Solution Acetaminophen LIQUID ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 325 mg/10.15mL 55154-9418_4bd9e2d7-61b2-4dd4-afe8-c1efe7c512d9 55154-9418 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride ELIXIR ORAL 19820210 ANDA ANDA087513 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 55154-9419_a7f42ce7-cc1c-43c4-acad-c95896a9a8c4 55154-9419 HUMAN PRESCRIPTION DRUG Sodium Citrate and Citric Acid SODIUM CITRATE and CITRIC ACID MONOHYDRATE SOLUTION ORAL 19690101 UNAPPROVED DRUG OTHER Cardinal Health CITRIC ACID MONOHYDRATE; SODIUM CITRATE 334; 500 mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 55154-9420_50d43743-40a3-49f7-8eb7-c8e1f7ff0e70 55154-9420 HUMAN OTC DRUG Guaifenesin and Dextromethorphan Guaifenesin and Dextromethorphan LIQUID ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health DEXTROMETHORPHAN; GUAIFENESIN 20; 200 ug/10mL; mg/10mL 55154-9422_aba5e4a2-5cad-41a9-92e2-735d19cab877 55154-9422 HUMAN OTC DRUG Mag-Al Plus XS Magnesium Hydroxide, Aluminum Hydroxide, Simethicone SUSPENSION ORAL 20110607 UNAPPROVED DRUG OTHER Cardinal Health ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 2400; 240; 2400 mg/30mL; mg/30mL; mg/30mL 55154-9425_ad32ef90-791a-47cc-bc75-684218b58431 55154-9425 HUMAN OTC DRUG Guaifenesin Guaifenesin LIQUID ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health GUAIFENESIN 200 mg/10mL 55154-9426_878e9df1-60e2-425d-8fee-4084435226dd 55154-9426 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL 19960730 ANDA ANDA074623 Cardinal Health LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 55154-9427_bec1edc8-c011-4f42-b67b-b8c681d870ee 55154-9427 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride SOLUTION ORAL 19910601 ANDA ANDA072744 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 55154-9428_faeaa1ed-7e4f-47c5-af2a-5f7e3f0fdf17 55154-9428 HUMAN OTC DRUG Guaifenesin Guaifenesin LIQUID ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health GUAIFENESIN 300 mg/15mL 55154-9429_c7e850b3-f01d-46a7-88ac-542e43beb30c 55154-9429 HUMAN OTC DRUG Mag-Al Plus Magnesium Hydroxide, Aluminum Hydroxide, Simethicone LIQUID ORAL 20110607 UNAPPROVED DRUG OTHER Cardinal Health ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 1200; 120; 1200 mg/30mL; mg/30mL; mg/30mL 55154-9430_32b86c45-4e69-4e10-b798-333b785d507f 55154-9430 HUMAN PRESCRIPTION DRUG Valproic Acid VALPROIC ACID SOLUTION ORAL 20050411 ANDA ANDA075379 Cardinal Health VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55154-9431_bcc5b20a-5869-4453-9d85-cdaa683ee5fa 55154-9431 HUMAN OTC DRUG Mag-Al Magnesium Hydroxide, Aluminum Hydroxide LIQUID ORAL 20110607 UNAPPROVED DRUG OTHER Cardinal Health ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE 1200; 1200 mg/30mL; mg/30mL 55154-9432_8c776d7b-4245-4f38-aeb4-ecc0d7a3374d 55154-9432 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate SUSPENSION ORAL 20091119 NDA NDA019183 Cardinal Health SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 55154-9433_a7c93c8a-2f95-40b6-a132-7055f5fe7050 55154-9433 HUMAN OTC DRUG Acetaminophen Oral Solution Acetaminophen LIQUID ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 160 mg/5mL 55154-9434_a9887d69-4de4-44d0-aee1-041a286bde24 55154-9434 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE SOLUTION ORAL 19690101 UNAPPROVED DRUG OTHER Cardinal Health POTASSIUM CHLORIDE 1.5 g/15mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55154-9436_ecaff9de-5ab0-4c7a-9c1f-17afeadde75d 55154-9436 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20090601 ANDA ANDA062512 Cardinal Health NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 55154-9437_b55e5028-bb05-48fb-a67c-0ba400b6ac3c 55154-9437 HUMAN OTC DRUG Guaifenesin Guaifenesin LIQUID ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health GUAIFENESIN 100 mg/5mL 55154-9438_e1c6e257-7b80-479d-aee7-eb48e14c8066 55154-9438 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090920 ANDA ANDA079120 Cardinal Health LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-9439_a26ee817-5c3a-4b82-9c71-bb5fa8da2f29 55154-9439 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate SOLUTION ORAL 20061001 UNAPPROVED DRUG OTHER Cardinal Health CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 55154-9440_5010af22-b449-495a-9992-4c92232170db 55154-9440 HUMAN PRESCRIPTION DRUG Megestrol Acetate MEGESTROL ACETATE SUSPENSION ORAL 20060707 ANDA ANDA076721 Cardinal Health MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 55154-9441_f6f2181b-10c3-4dfd-8bc9-955572fe39c0 55154-9441 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE SOLUTION ORAL 19690101 UNAPPROVED DRUG OTHER Cardinal Health POTASSIUM CHLORIDE 1.5 g/15mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55154-9442_2abec441-3eac-4c0e-a05a-369a1ef0e51f 55154-9442 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 20110610 ANDA ANDA087508 Cardinal Health ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 55154-9443_86aac144-c52d-45d7-b09c-b14db8a2dc41 55154-9443 HUMAN PRESCRIPTION DRUG LACTULOSE LACTULOSE SOLUTION ORAL 19660730 ANDA ANDA074623 Cardinal Health LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 55154-9444_5989098d-2855-4b5f-9a06-64a83656c078 55154-9444 HUMAN PRESCRIPTION DRUG AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE SOLUTION ORAL 19950717 ANDA ANDA074509 Cardinal Health AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 55154-9477_01dceb7b-7bfb-4007-8138-46e1c766830d 55154-9477 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20010524 ANDA ANDA084903 Cardinal Health PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55154-9525_b5def1d8-31f6-414b-a788-c815c086eede 55154-9525 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111017 ANDA ANDA078034 Cardinal Health SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55154-9552_df42df85-1ce1-41e8-876f-40d4a8c8b67d 55154-9552 HUMAN PRESCRIPTION DRUG Gentamicin GENTAMICIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19820304 ANDA ANDA062356 Cardinal Health GENTAMICIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 55154-9553_e68d4606-cd63-44d6-9683-6ca82c2a565a 55154-9553 HUMAN PRESCRIPTION DRUG Haloperidol HALOPERIDOL LACTATE INJECTION, SOLUTION INTRAMUSCULAR 20101215 ANDA ANDA075689 Cardinal Health HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] 55154-9554_28c342d7-f429-48eb-b683-c6117aad9410 55154-9554 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride HYDRALAZINE HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20110131 ANDA ANDA040388 Cardinal Health HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 55154-9555_553a0e06-8ef1-4edc-a81d-47662ec1a366 55154-9555 HUMAN PRESCRIPTION DRUG Ampicillin ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19870512 ANDA ANDA062719 Cardinal Health AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55154-9557_3858775b-61a0-4ef5-a944-0f4ffdf33779 55154-9557 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041130 ANDA ANDA040583 Cardinal Health METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-9559_e117f4c9-50d9-4ab0-ad16-9f17f1dab59a 55154-9559 HUMAN PRESCRIPTION DRUG CEFAZOLIN CEFAZOLIN SODIUM POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110715 ANDA ANDA065303 Cardinal Health CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55154-9560_20fcbb57-edde-4f6c-adf3-0d3a23c8f543 55154-9560 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-9562_959203df-fea9-4af8-8168-d006828e589e 55154-9562 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 Cardinal Health MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55154-9563_755f0acc-b124-4226-b468-eceadd26e2ea 55154-9563 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-9564_540ef816-eb03-469b-8b1d-99ce190fe6a3 55154-9564 HUMAN PRESCRIPTION DRUG SENSORCAINE MPF BUPIVACAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; RETROBULBAR 20101119 ANDA ANDA018304 Cardinal Health BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 7.5; .00091 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-9565_755f0acc-b124-4226-b468-eceadd26e2ea 55154-9565 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 Cardinal Health EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 5 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-9566_86d131f9-e25a-4731-a201-2b6d3e0a7974 55154-9566 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 Cardinal Health EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS .01; 10 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-9567_86d131f9-e25a-4731-a201-2b6d3e0a7974 55154-9567 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 Cardinal Health EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS .01; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-9568_86d131f9-e25a-4731-a201-2b6d3e0a7974 55154-9568 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812 NDA NDA006488 Cardinal Health EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS .005; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-9569_86d131f9-e25a-4731-a201-2b6d3e0a7974 55154-9569 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-9572_86d131f9-e25a-4731-a201-2b6d3e0a7974 55154-9572 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-9573_b7e61ad4-2005-4fb0-9858-4fef7e73eeda 55154-9573 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-9574_e0550eeb-81e3-4feb-a2be-11bbd52b3673 55154-9574 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-9575_1f80e4aa-232e-4110-b22f-3d29a9ff06ea 55154-9575 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 Cardinal Health EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS .01; 10 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55154-9605_d4fb2aab-1116-4854-b567-e7d951fdf641 55154-9605 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20100819 NDA NDA021153 Cardinal Health ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55154-9606_d4fb2aab-1116-4854-b567-e7d951fdf641 55154-9606 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20100819 NDA NDA021153 Cardinal Health ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55154-9607_b2adbf5d-dccd-41ff-9f12-4e606ccb541f 55154-9607 HUMAN PRESCRIPTION DRUG XYLOCAINE Lidocaine hydrochloride JELLY TOPICAL 20120716 NDA NDA008816 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-9608_e3fee196-eae5-45f2-97ec-09141481d562 55154-9608 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20100510 NDA NDA019962 Cardinal Health METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-9609_e3fee196-eae5-45f2-97ec-09141481d562 55154-9609 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20100510 NDA NDA019962 Cardinal Health METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55154-9610_45b0967b-c0fd-409c-987c-c074570d4193 55154-9610 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 20091111 NDA NDA020838 Cardinal Health CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-9613_14355f76-caa3-4c12-957a-9605e5c0f09c 55154-9613 HUMAN PRESCRIPTION DRUG PULMICORT RESPULES Budesonide SUSPENSION RESPIRATORY (INHALATION) 20091120 NDA NDA020929 Cardinal Health BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55154-9614_d4fb2aab-1116-4854-b567-e7d951fdf641 55154-9614 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20070319 NDA NDA021957 Cardinal Health ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55154-9615_dce12085-d6c4-48a5-959b-e771c413c9c5 55154-9615 HUMAN PRESCRIPTION DRUG NEXIUM I.V. Esomeprazole sodium INJECTION INTRAVENOUS 20050503 NDA NDA021689 Cardinal Health ESOMEPRAZOLE SODIUM 40 mg/5mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55154-9616_e6020a31-8790-4ca1-ab7f-9aaaf33b227a 55154-9616 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010319 NDA NDA021153 Cardinal Health ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55154-9625_1ea4f331-1658-416b-9a54-e3d18dd4a554 55154-9625 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 19960507 ANDA ANDA074356 Cardinal Health CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] 55154-9626_fc7b0311-fb8b-42f4-ad2b-fc3948c7b678 55154-9626 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19950710 ANDA ANDA040014 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55154-9657_990afabe-cafa-4e10-ac37-c5f93b7af592 55154-9657 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Cardinal Health VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-9659_a1542aa1-09af-46ef-a518-d075204d0c45 55154-9659 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Cardinal Health HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-9663_a1542aa1-09af-46ef-a518-d075204d0c45 55154-9663 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Cardinal Health HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-9664_a1542aa1-09af-46ef-a518-d075204d0c45 55154-9664 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Cardinal Health HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-9665_990afabe-cafa-4e10-ac37-c5f93b7af592 55154-9665 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Cardinal Health VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-9666_a1542aa1-09af-46ef-a518-d075204d0c45 55154-9666 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20060428 NDA NDA020818 Cardinal Health HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-9667_a1542aa1-09af-46ef-a518-d075204d0c45 55154-9667 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20060428 NDA NDA020818 Cardinal Health HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55154-9668_e11652b8-6ce6-4366-9519-a43a0d36f235 55154-9668 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 Cardinal Health AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55154-9726_275ede4f-59ff-44c3-adc2-86bee35c1247 55154-9726 HUMAN PRESCRIPTION DRUG Renagel sevelamer hydrochloride TABLET ORAL 20080606 NDA NDA021179 Cardinal Health SEVELAMER HYDROCHLORIDE 400 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 55154-9727_275ede4f-59ff-44c3-adc2-86bee35c1247 55154-9727 HUMAN PRESCRIPTION DRUG Renagel sevelamer hydrochloride TABLET ORAL 20080606 NDA NDA021179 Cardinal Health SEVELAMER HYDROCHLORIDE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 55154-9728_d5e0d75f-5d81-4c05-85ee-71b4651773bf 55154-9728 HUMAN PRESCRIPTION DRUG Renvela SEVELAMER CARBONATE TABLET, FILM COATED ORAL 20090812 NDA NDA022127 Cardinal Health SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 55154-9752_631cef56-1485-450c-9c73-20f590973857 55154-9752 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20110603 UNAPPROVED DRUG OTHER Cardinal Health LORATADINE 10 mg/1 55165-0104_5dfdc506-d989-47aa-8104-23b7421d1e4b 55165-0104 HUMAN OTC DRUG SPF-30 SPORT moisturizer Zinc Oxide LOTION TOPICAL 20120603 OTC MONOGRAPH FINAL part352 Juice Beauty ZINC OXIDE 20 g/100mL 55221-0001_f0ea06d3-5edd-4dad-b26e-e00fe82102a3 55221-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980615 UNAPPROVED MEDICAL GAS Cox Health Home Support OXYGEN 99 L/100L 55239-001_6514a826-069b-4d57-b12e-e603c5640d75 55239-001 HUMAN OTC DRUG olio activ mouthwash cinnamon CETYLPYRIDINIUM CHLORIDE LIQUID ORAL 20140709 OTC MONOGRAPH NOT FINAL part356 Kleen Test Products Corporation CETYLPYRIDINIUM CHLORIDE .5 mg/mL 55239-002_97fcb25b-bb22-4405-927a-db04563c8e6b 55239-002 HUMAN OTC DRUG olio activ mouthwash spearmint CETYLPYRIDINIUM CHLORIDE LIQUID ORAL 20140709 OTC MONOGRAPH NOT FINAL part356 Kleen Test Products Corporation CETYLPYRIDINIUM CHLORIDE .5 mg/mL 55239-003_c4ef5f66-abe4-4eea-a736-f3efcd32b6e8 55239-003 HUMAN OTC DRUG olio activ mouthwash freshmint CETYLPYRIDINIUM CHLORIDE LIQUID ORAL 20140709 OTC MONOGRAPH NOT FINAL part356 Kleen Test Products Corporation CETYLPYRIDINIUM CHLORIDE .5 mg/mL 55249-1001_c2b21fe1-ae95-4540-9367-39076ebfa93c 55249-1001 HUMAN OTC DRUG Tosowoong Mens Booster Repair Skin ARBUTIN LIQUID TOPICAL 20130705 UNAPPROVED DRUG OTHER Mantong ARBUTIN 1 mg/150mL 55249-2001_0afa4f9a-c053-42fb-8e91-e10066d2608f 55249-2001 HUMAN OTC DRUG Tosowoong Mens Booster Repair ADENOSINE LOTION TOPICAL 20130705 UNAPPROVED DRUG OTHER Mantong ADENOSINE 1 mg/150mL 55253-070_ece3d701-9710-411a-aa61-0d4b22eba293 55253-070 HUMAN PRESCRIPTION DRUG fentanyl citrate fentanyl citrate LOZENGE TRANSMUCOSAL 20060906 NDA AUTHORIZED GENERIC NDA020747 CIMA Laboratories, Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55253-071_ece3d701-9710-411a-aa61-0d4b22eba293 55253-071 HUMAN PRESCRIPTION DRUG fentanyl citrate fentanyl citrate LOZENGE TRANSMUCOSAL 20060906 NDA AUTHORIZED GENERIC NDA020747 CIMA Laboratories, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55253-072_ece3d701-9710-411a-aa61-0d4b22eba293 55253-072 HUMAN PRESCRIPTION DRUG fentanyl citrate fentanyl citrate LOZENGE TRANSMUCOSAL 20060906 NDA AUTHORIZED GENERIC NDA020747 CIMA Laboratories, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55253-073_ece3d701-9710-411a-aa61-0d4b22eba293 55253-073 HUMAN PRESCRIPTION DRUG fentanyl citrate fentanyl citrate LOZENGE TRANSMUCOSAL 20060906 NDA AUTHORIZED GENERIC NDA020747 CIMA Laboratories, Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55253-074_ece3d701-9710-411a-aa61-0d4b22eba293 55253-074 HUMAN PRESCRIPTION DRUG fentanyl citrate fentanyl citrate LOZENGE TRANSMUCOSAL 20060906 NDA AUTHORIZED GENERIC NDA020747 CIMA Laboratories, Inc. FENTANYL CITRATE 1200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55253-075_ece3d701-9710-411a-aa61-0d4b22eba293 55253-075 HUMAN PRESCRIPTION DRUG fentanyl citrate fentanyl citrate LOZENGE TRANSMUCOSAL 20060906 NDA AUTHORIZED GENERIC NDA020747 CIMA Laboratories, Inc. FENTANYL CITRATE 1600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55253-276_3e10f595-f026-4bfc-a0db-d6d135c80f78 55253-276 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071002 20150228 NDA AUTHORIZED GENERIC NDA021777 CIMA LABS INC CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55253-277_3e10f595-f026-4bfc-a0db-d6d135c80f78 55253-277 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071101 20150228 NDA AUTHORIZED GENERIC NDA021777 CIMA LABS INC CYCLOBENZAPRINE HYDROCHLORIDE 30 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55253-600_25225511-70b8-4377-ad4f-6629025ac75f 55253-600 HUMAN PRESCRIPTION DRUG tiagabine hydrochloride tiagabine hydrochloride TABLET ORAL 20121226 NDA AUTHORIZED GENERIC NDA020646 CIMA Laboratories, Inc. TIAGABINE HYDROCHLORIDE 2 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55253-601_25225511-70b8-4377-ad4f-6629025ac75f 55253-601 HUMAN PRESCRIPTION DRUG tiagabine hydrochloride tiagabine hydrochloride TABLET ORAL 20121226 NDA AUTHORIZED GENERIC NDA020646 CIMA Laboratories, Inc. TIAGABINE HYDROCHLORIDE 4 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55253-801_9f3b0bd2-72a3-411f-aeec-b533373f1a97 55253-801 HUMAN PRESCRIPTION DRUG modafinil modafinil TABLET ORAL 20120329 NDA AUTHORIZED GENERIC NDA020717 CIMA Labs Inc MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 55253-802_9f3b0bd2-72a3-411f-aeec-b533373f1a97 55253-802 HUMAN PRESCRIPTION DRUG modafinil modafinil TABLET ORAL 20120329 NDA AUTHORIZED GENERIC NDA020717 CIMA Labs Inc MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 55259-1001_dca166e2-4401-4348-925a-2f62ae3036bb 55259-1001 HUMAN OTC DRUG 7030 Calcium Gold CALCIUM CAPSULE ORAL 20130310 UNAPPROVED DRUG OTHER Apexel Co., Ltd CALCIUM .99 1/1 55259-2001_0353adbd-40c2-4b98-b475-1be1bf907695 55259-2001 HUMAN OTC DRUG 7030 Calcium Premium CALCIUM CAPSULE ORAL 20130310 UNAPPROVED DRUG OTHER Apexel Co., Ltd CALCIUM .99 1/1 55264-001_a2835b9e-fe09-4698-b0e2-141706449d40 55264-001 HUMAN OTC DRUG SHOPKO HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 20110208 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP. HYDROCORTISONE 1 g/100g 55264-005_c76a92ff-2865-42d5-ac74-5ee8acba402f 55264-005 HUMAN OTC DRUG GINSENGGO Camphor, Menthol, Methyl Salicylate PATCH CUTANEOUS; TOPICAL; TRANSDERMAL 20130822 OTC MONOGRAPH NOT FINAL part348 Sinsin Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE .7; 1.4; 2.8 mg/1; mg/1; mg/1 55264-007_6f5d826c-182e-42b8-bd64-26b6d00320f8 55264-007 HUMAN OTC DRUG Sinsin Mulpas Camphor, Menthol, Methyl Salicylate LIQUID CUTANEOUS; TOPICAL; TRANSDERMAL 20140110 OTC MONOGRAPH NOT FINAL part348 Sinsin Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 4.5; 4.2; 6.9 mg/mL; mg/mL; mg/mL 55264-011_d9316435-fb4b-4399-abce-05f20347dd6e 55264-011 HUMAN OTC DRUG Air Sinsin Pas Camphor, Menthol, Methyl salicylate AEROSOL, SPRAY CUTANEOUS; TOPICAL; TRANSDERMAL 20110701 OTC MONOGRAPH FINAL part348 Sinsin Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE .361; .289; .361 g/100mL; g/100mL; g/100mL 55264-020_62a5368c-f650-4a4b-a336-0e458b1fce71 55264-020 HUMAN OTC DRUG Arex Sinsin Pas Camphor, Mentha Oil, Menthol, Methyl Salicylate, Zinc Oxide PATCH CUTANEOUS; TOPICAL; TRANSDERMAL 20130726 OTC MONOGRAPH NOT FINAL part348 Sinsin Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE; PEPPERMINT OIL; ZINC OXIDE 17.05; 45.45; 45.45; 22.73; 215.91 mg/1; mg/1; mg/1; mg/1; mg/1 55264-021_0f755aae-696b-4a24-bfde-b4133eb2c6a2 55264-021 HUMAN OTC DRUG Arex Sinsin Pas Camphor, Mentha Oil, Menthol, Methyl Salicylate, Zinc Oxide PATCH CUTANEOUS; TOPICAL; TRANSDERMAL 20130726 OTC MONOGRAPH NOT FINAL part348 Sinsin Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE; PEPPERMINT OIL; ZINC OXIDE 34.1; 90.9; 90.9; 45.46; 431.82 mg/1; mg/1; mg/1; mg/1; mg/1 55264-269_50f5a131-ae2a-42b5-8889-77be126f5c16 55264-269 HUMAN OTC DRUG Medicated Heat Capsicum PATCH TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part348 United Exchange Corporation CAPSAICIN .6 mg/1 55264-626_aa5590a2-3ac5-4924-8941-cf79826672fd 55264-626 HUMAN OTC DRUG SHOPKO TRIPLE ANTIBIOTIC PLUS BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE OINTMENT TOPICAL 20110106 OTC MONOGRAPH FINAL part333B UNITED EXCHANGE CORP. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 55277-1001_add50493-e2bc-4a51-b5f7-928905ed687e 55277-1001 HUMAN OTC DRUG PANCOLD S GUAIFENESIN LIQUID ORAL 20130115 OTC MONOGRAPH FINAL part341 Kafus Co., Ltd ACETAMINOPHEN; CAFFEINE; CHLORPHENIRAMINE; GUAIFENESIN; METHYLEPHEDRINE HYDROCHLORIDE, DL- 300; 30; 2.5; 83.3; 17.5 mg/30mL; mg/30mL; mg/30mL; mg/30mL; mg/30mL 55282-1001_a7e18cae-73f6-4c8c-8be8-19c75f087af4 55282-1001 HUMAN OTC DRUG PiGe ll Real Skin Mask Pack SUS SCROFA SKIN LIQUID TOPICAL 20130114 UNAPPROVED DRUG OTHER Osung Co., Ltd SUS SCROFA SKIN 8 g/100g 55282-2001_53f655af-53ff-46d7-a2b5-d0ea7714343d 55282-2001 HUMAN OTC DRUG PiGe ll Real Skin Neck Pack SUS SCROFA SKIN LIQUID TOPICAL 20130114 UNAPPROVED DRUG OTHER Osung Co., Ltd SUS SCROFA SKIN 8 g/100g 55282-3001_405c1a1f-0683-4196-a98e-7ce4089417ae 55282-3001 HUMAN OTC DRUG PiGe ll Real Skin Eye SUS SCROFA SKIN PATCH TOPICAL 20130114 UNAPPROVED DRUG OTHER Osung Co., Ltd SUS SCROFA SKIN 8 g/100g 55287-100_9cdb77bc-a883-4e1e-ac32-c2ae1af3afe6 55287-100 HUMAN OTC DRUG Green Tussin DM Guaifenesin, Dextromethorphan HBr LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Green Choice for Life DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/15mL; mg/15mL 55287-101_8cc66bd5-78dc-409f-86a9-c9d08e3358b4 55287-101 HUMAN OTC DRUG Green Tussin SUGAR FREE DM Green Tussin SUGAR FREE DM LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Green Choice for Life DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/15mL; mg/15mL 55287-102_731e1b79-9713-43ec-9900-7a9fc5156c1b 55287-102 HUMAN OTC DRUG Green Relief Bismuth Subsalicylate LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part335 Green Choice for Life BISMUTH SUBSALICYLATE 262 mg/15mL 55289-002_0bf4f456-18eb-49df-bd0b-8b0c3d90c81d 55289-002 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20020726 ANDA ANDA076268 PD-Rx Pharmaceuticals, Inc. DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 55289-005_45ecafa7-b72c-4caa-ad73-d1be38548f35 55289-005 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 55289-007_6ac5c892-084a-46ab-aa9f-f89b5100a024 55289-007 HUMAN PRESCRIPTION DRUG Trileptal oxcarbazepine TABLET, FILM COATED ORAL 20000130 NDA NDA021014 PD-Rx Pharmaceuticals, Inc. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55289-010_fea38360-9354-48d6-9f82-d9a65983cd20 55289-010 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 PD-Rx Pharmaceuticals, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 55289-012_b852757c-e258-4619-b31d-6faa0b88c2d5 55289-012 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride amantadine hydrochloride CAPSULE, GELATIN COATED ORAL 20110915 ANDA ANDA070589 PD-Rx Pharmaceuticals, Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 55289-014_3322979c-bdd4-4741-9c60-e1478ff88d83 55289-014 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 PD-Rx Pharmaceuticals, Inc. ESZOPICLONE 3 mg/1 CIV 55289-016_87fca5ab-9d3d-4d2a-a361-439788da09f9 55289-016 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 PD-Rx Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 55289-017_a8ab79d7-7f87-492f-9c65-e1f3771fe161 55289-017 HUMAN PRESCRIPTION DRUG Robaxin Methocarbamol TABLET, FILM COATED ORAL 20030120 NDA NDA011011 PD-Rx Pharmaceuticals, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55289-018_f6b006d5-2fd8-44c1-a6d4-0c7317fd51f3 55289-018 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20110504 ANDA ANDA070791 PD-Rx Pharmaceuticals, Inc. DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 55289-019_207ab829-5d40-4e8a-86a2-620eee00b4e9 55289-019 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20111118 ANDA ANDA061926 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55289-020_cb29bb44-915e-4e22-a376-0735d68798b9 55289-020 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19900930 ANDA ANDA061926 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55289-022_d937ee63-673d-4b1c-9ff1-fca25f63bf0f 55289-022 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20111027 ANDA ANDA075509 PD-Rx Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55289-023_bba1fcd5-9866-4ef3-9afc-58d254f823e4 55289-023 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 19950829 ANDA ANDA064082 PD-Rx Pharmaceuticals, Inc. AMPICILLIN TRIHYDRATE 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55289-024_0374652a-2abb-4d24-b9ae-17dca0b15b56 55289-024 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 19880225 ANDA ANDA062882 PD-Rx Pharmaceuticals, Inc. AMPICILLIN TRIHYDRATE 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55289-025_cf992520-ac9e-4dd3-939a-d0db46691ca5 55289-025 HUMAN PRESCRIPTION DRUG Erythromycin Base Erythromycin TABLET, FILM COATED ORAL 20110906 ANDA ANDA061621 PD-Rx Pharmaceuticals, Inc. ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55289-028_0c30a2fc-b776-42f3-a599-38d355516b61 55289-028 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20100115 NDA NDA021427 PD-Rx Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55289-036_63e7c93c-f395-4dd8-9c46-8bf5adde339a 55289-036 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 PD-Rx Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55289-037_cdaaa054-d530-40d7-84ef-d5417ec7c3ab 55289-037 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20110816 ANDA ANDA078902 PD-Rx Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55289-038_c50250dc-c50b-443e-99e2-0250fc24eed2 55289-038 HUMAN PRESCRIPTION DRUG Flurazepam Hydrochloride flurazepam hydrochloride CAPSULE ORAL 20100716 ANDA ANDA070345 PD-Rx Pharmaceuticals, Inc. FLURAZEPAM HYDROCHLORIDE 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-039_0996f64f-314c-488a-ac8a-682e54c08448 55289-039 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55289-040_c9858b1f-8d7a-4c4d-bdd2-cae1ab75f9d0 55289-040 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine TABLET ORAL 19790605 ANDA ANDA086162 PD-Rx Pharmaceuticals, Inc. ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 55289-045_3f8b1d47-bb74-4e95-bb5e-ffebee633b45 55289-045 HUMAN PRESCRIPTION DRUG Albuterol albuterol sulfate TABLET ORAL 20110504 ANDA ANDA072894 PD-Rx Pharmaceuticals, Inc. ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 55289-048_eea44671-f761-4b46-aea0-975ee6d4acaa 55289-048 HUMAN PRESCRIPTION DRUG TYLENOL with Codeine acetaminophen and codeine phosphate TABLET ORAL 19770817 ANDA ANDA085055 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 55289-049_92f1b78a-1c48-4e4c-bc47-4bab32b1170c 55289-049 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19871101 ANDA ANDA087499 PD-Rx Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 55289-052_5fad163f-f7c8-46b0-bee9-40dbf611b97c 55289-052 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20101102 ANDA ANDA074131 PD-Rx Pharmaceuticals, Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-053_4e67334f-cd80-43e5-92c0-38cac21d147c 55289-053 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20110816 ANDA ANDA078902 PD-Rx Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55289-054_29be5c0e-2f35-4f14-b2d7-83fb2c2fcb74 55289-054 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20110629 ANDA ANDA077919 PD-Rx Pharmaceuticals, Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 55289-055_140dc9a1-b6bc-4e99-a3f6-3b03f111e027 55289-055 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720228 ANDA ANDA080212 PD-Rx Pharmaceuticals, Inc. ISONIAZID 100 mg/1 Antimycobacterial [EPC] 55289-057_d3506024-3d57-46be-85fb-67427e460252 55289-057 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110128 ANDA ANDA062702 PD-Rx Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 55289-058_2d925f1e-30e6-456a-84d4-05c2de39b360 55289-058 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110128 ANDA ANDA062702 PD-Rx Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 55289-060_141ceb0e-6721-4f65-96ba-8a7f5761030b 55289-060 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071525 PD-Rx Pharmaceuticals, Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 55289-061_17e833f8-2ee7-4c48-990e-94ed3d396c11 55289-061 HUMAN PRESCRIPTION DRUG CHLORDIAZE-POXIDE HCL chlordiazepoxide hydrochloride CAPSULE ORAL 20100101 ANDA ANDA040746 PD-Rx Pharmaceuticals, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-064_d8eb58b1-5963-45ae-80c9-af5c92b4fffa 55289-064 HUMAN PRESCRIPTION DRUG TRAZODONE TRAZODONE HYDROCHLORIDE TABLET ORAL 20100101 ANDA ANDA071523 PD-Rx Pharmaceuticals, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 55289-065_6130a321-9581-4067-93cb-e162d9c8d6d2 55289-065 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970829 ANDA ANDA074979 PD-Rx Pharmaceuticals, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-066_de68c154-b63f-4494-be47-530eb79e31ca 55289-066 HUMAN PRESCRIPTION DRUG Chlorpropamide chlorpropamide TABLET ORAL 20110504 ANDA ANDA088549 PD-Rx Pharmaceuticals, Inc. CHLORPROPAMIDE 250 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55289-067_c0c18979-baae-4435-bf32-5a6f198f1575 55289-067 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 20091118 ANDA ANDA086831 PD-Rx Pharmaceuticals, Inc. CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 55289-073_dc23a304-c10e-48f0-8414-9d2c485f7406 55289-073 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20090903 ANDA ANDA070317 PD-Rx Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55289-074_1552e82c-55d9-4f87-84e8-4e4c0ff6218c 55289-074 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20090903 ANDA ANDA070317 PD-Rx Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55289-075_f236ce36-b6d0-4b25-870a-d130e4b5aa89 55289-075 HUMAN PRESCRIPTION DRUG Erythromycin Base Base Erythromycin TABLET, FILM COATED ORAL 20110906 ANDA ANDA061621 PD-Rx Pharmaceuticals, Inc. ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55289-076_820df90f-2e94-40e9-8690-4844e93ec2c1 55289-076 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55289-077_420ec033-2d21-4632-8896-0f2dd24b297b 55289-077 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride TABLET, FILM COATED ORAL 20110225 NDA NDA021085 PD-Rx Pharmaceuticals, Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55289-081_57770763-077b-48f2-9242-6d14a9c9f145 55289-081 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20110114 ANDA ANDA065368 PD-Rx Pharmaceuticals, Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55289-082_965b1a44-57b5-4fc5-b9a2-880a7fa99d35 55289-082 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20100118 ANDA ANDA076187 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55289-084_63dfc8e8-77de-4022-8d11-678ea691c271 55289-084 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20120808 ANDA ANDA076187 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55289-085_54ddbcb8-d918-4ed5-9e04-be7766166c4c 55289-085 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20100118 ANDA ANDA076187 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55289-086_ae7ff91e-3b05-46cb-a064-97e6bd4f6e0a 55289-086 HUMAN PRESCRIPTION DRUG Lotensin Benazepril Hydrochloride TABLET ORAL 19910625 NDA NDA019851 PD-Rx Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55289-090_760ed503-de5b-47d1-8b54-dca230684615 55289-090 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA073449 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55289-091_25703444-3003-4e8d-8b02-879fa4bab6fd 55289-091 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071135 PD-Rx Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-092_2f39cb8d-4a75-437f-ae97-18daae44e8bb 55289-092 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20091120 ANDA ANDA070325 PD-Rx Pharmaceuticals, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-093_409f2f1c-ada7-4c59-b142-b21e64bce9f5 55289-093 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19940527 ANDA ANDA074217 PD-Rx Pharmaceuticals, Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55289-094_c421f83e-0afd-4fcc-9a4a-5491809923b0 55289-094 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19710401 ANDA ANDA061454 PD-Rx Pharmaceuticals, Inc. DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55289-095_3253c945-e5d4-43f4-9ce1-0dfcf062d45e 55289-095 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 PD-Rx Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 55289-096_14fde9a2-d8eb-47fe-abcc-9e890517bccd 55289-096 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55289-097_a48fc138-fa15-44f7-8ebc-e2a06cf7d2df 55289-097 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20000424 NDA NDA021035 PD-Rx Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55289-098_1ad03043-e7e9-47cd-a561-8f717fb0cebb 55289-098 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 19840702 NDA NDA020405 PD-Rx Pharmaceuticals, Inc. DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 55289-099_32773ba6-71f2-441f-aa90-391cec10e0ca 55289-099 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073554 PD-Rx Pharmaceuticals, Inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 55289-102_a60dd5fb-0e29-4858-a677-5003aab1d8a0 55289-102 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 PD-Rx Pharmaceuticals, Inc. ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 55289-103_800bf859-d823-4d1a-a014-5c1cbc1691df 55289-103 HUMAN PRESCRIPTION DRUG Norvasc amlodipine besylate TABLET ORAL 19920731 NDA NDA019787 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55289-106_4a0bc106-d3ae-4841-8cfb-ec7c3df568a3 55289-106 HUMAN PRESCRIPTION DRUG ZESTRIL Lisinopril TABLET ORAL 20111109 NDA NDA019777 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 55289-107_0c61ce56-7d05-4915-9093-8d75d43fc4ad 55289-107 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840507 ANDA ANDA062396 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 55289-110_5f0ac397-0cbe-4f14-acca-0d3da7f316e7 55289-110 HUMAN PRESCRIPTION DRUG E.E.S. Erythromycin Ethylsuccinate TABLET, FILM COATED ORAL 20101216 ANDA ANDA061905 PD-Rx Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 400 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55289-112_b0b317ef-032b-413e-8688-c955799fc1cc 55289-112 HUMAN PRESCRIPTION DRUG Erythrocin Stearate ERYTHROMYCIN STEARATE TABLET, FILM COATED ORAL 20110801 ANDA ANDA060359 PD-Rx Pharmaceuticals, Inc. ERYTHROMYCIN STEARATE 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55289-117_245a7d14-ddae-48fc-87cc-e097e0583edd 55289-117 HUMAN PRESCRIPTION DRUG Valium diazepam TABLET ORAL 19631115 NDA NDA013263 PD-Rx Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-118_ced8d1ad-8432-4b85-9a36-0edabde62624 55289-118 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 PD-Rx Pharmaceuticals, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55289-119_0b0565ab-d6eb-4542-a874-6f12213b9774 55289-119 HUMAN PRESCRIPTION DRUG Compro PROCHLORPERAZINE SUPPOSITORY RECTAL 20000901 ANDA ANDA040246 PD-Rx Pharmaceuticals, Inc. PROCHLORPERAZINE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55289-124_b219081a-29ba-4ea6-aed7-c519f7265f01 55289-124 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 PD-Rx Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 55289-125_962c04dd-f3b6-4553-8cd9-927962f140a2 55289-125 HUMAN PRESCRIPTION DRUG Glucotrol glipizide TABLET ORAL 19840508 NDA NDA017783 PD-Rx Pharmaceuticals, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55289-132_ffbe3980-5e97-4072-ad12-d341921f108c 55289-132 HUMAN PRESCRIPTION DRUG Detrol LA tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20000222 NDA NDA021228 PD-Rx Pharmaceuticals, Inc. TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 55289-135_9eb70a5d-8111-46bc-9b79-98dd5e421c0f 55289-135 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55289-136_73eeb39d-11b9-44b6-aa28-9686ccf1ebaf 55289-136 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20060801 ANDA ANDA084878 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55289-138_2f9ac9c4-72ba-43ef-b35f-7bc762660b62 55289-138 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20050527 ANDA ANDA040580 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 55289-139_6900fee2-ae62-4734-96e4-0c4070513e4e 55289-139 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20101207 ANDA ANDA088618 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 55289-140_f1145a8d-6498-4471-b250-ced19199dcd7 55289-140 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 PD-Rx Pharmaceuticals, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-142_e882c04f-0115-4bf4-a704-35549d7b5073 55289-142 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 PD-Rx Pharmaceuticals, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-144_5baf8401-3d89-436e-b0da-f8d34e725ff0 55289-144 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19760420 ANDA ANDA083745 PD-Rx Pharmaceuticals, Inc. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 55289-147_cb67c67c-56b3-4683-b448-5f3d4173e787 55289-147 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 20100915 ANDA ANDA018858 PD-Rx Pharmaceuticals, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-148_4d5811df-c5c2-4180-b47c-16d3fbf106b8 55289-148 HUMAN PRESCRIPTION DRUG Diflucan fluconazole TABLET ORAL 19900129 NDA NDA019949 PD-Rx Pharmaceuticals, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55289-150_20e7c235-b932-4aac-af1d-34809dce4b6d 55289-150 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 PD-Rx Pharmaceuticals, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-151_2c448513-5382-49f0-a0f5-605e76ac5892 55289-151 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 19961125 NDA NDA020690 PD-Rx Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55289-153_851e7e6c-9152-464c-8000-4c3cf238bb3c 55289-153 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20100118 ANDA ANDA076187 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55289-154_7bd7d0f7-43b2-445e-bb9c-7803d5235885 55289-154 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55289-158_f677552f-7eff-4576-b89e-42208437a6c0 55289-158 HUMAN PRESCRIPTION DRUG BENZPHETAMINE HYDROCHLORIDE BENAPHETAMINE TABLET ORAL 20091209 ANDA ANDA040747 PD-Rx Pharmaceuticals, Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 55289-160_3bfca270-9556-4629-83c4-af2fbc2bc7de 55289-160 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 20110118 ANDA ANDA040159 PD-Rx Pharmaceuticals, Inc. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 55289-164_320e0d4b-e80a-40cd-95a4-b69cb91e03b8 55289-164 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19871101 ANDA ANDA084276 PD-Rx Pharmaceuticals, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55289-166_626d3e0a-de11-464a-820a-4f2b4798cea0 55289-166 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19950928 ANDA ANDA074376 PD-Rx Pharmaceuticals, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-168_79a9fe5d-8ddb-4179-a091-ecb30dec51a8 55289-168 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110401 ANDA ANDA077487 PD-Rx Pharmaceuticals, Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55289-171_0e2eab10-3705-4a4f-ba6d-ca280a52ebb3 55289-171 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20080507 ANDA ANDA078470 PD-Rx Pharmaceuticals, Inc. ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 55289-172_32f92f73-4373-4088-a2fe-06ac0085eee7 55289-172 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070027 PD-Rx Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 55289-175_944f3646-93f9-4f96-af5f-94d6e9a5a3af 55289-175 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 PD-Rx Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 55289-176_1c87f1d7-09ff-4b8d-b527-d797ccfe40f8 55289-176 HUMAN PRESCRIPTION DRUG Sulfasalazine sulfasalazine TABLET ORAL 20020111 ANDA ANDA040349 PD-Rx Pharmaceuticals, Inc. SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 55289-181_fd1d6153-3f37-48f4-898c-560b50066265 55289-181 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 20110118 ANDA ANDA073517 PD-Rx Pharmaceuticals, Inc. KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-182_de346d0a-f8d8-40cc-8f56-658355298023 55289-182 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, CHEWABLE ORAL 20100128 ANDA ANDA064013 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55289-186_f57dd9e8-d54e-43db-a263-73ffef7d9e84 55289-186 HUMAN PRESCRIPTION DRUG Nitrofurantoin (macrocrystals) nitrofurantoin (macrocrystals) CAPSULE ORAL 20110506 ANDA ANDA074967 PD-Rx Pharmaceuticals, Inc. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 55289-187_ea7d42b8-eeb7-464e-a70b-7c48a95e8e1d 55289-187 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20111118 NDA NDA020639 PD-Rx Pharmaceuticals, Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 55289-193_bfb9746a-dd11-4507-bcb3-5b268fa37415 55289-193 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20110422 NDA NDA021400 PD-Rx Pharmaceuticals, Inc. VARDENAFIL HYDROCHLORIDE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 55289-194_49524823-d1d7-4146-932e-a6a3fed59a1f 55289-194 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20080515 NDA NDA021400 PD-Rx Pharmaceuticals, Inc. VARDENAFIL HYDROCHLORIDE 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 55289-196_edcd52be-90d5-4583-9ee7-cf30d05fe013 55289-196 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 PD-Rx Pharmaceuticals, Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-201_aeb7e0d4-2ba4-4537-9160-86e3441e814e 55289-201 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063065 PD-Rx Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 55289-202_1f0d3899-379f-414e-90f8-d0a01c62a83e 55289-202 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063181 PD-Rx Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 55289-203_eb8c8bb7-fb38-4645-af75-84ec02f78842 55289-203 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20110110 ANDA ANDA073652 PD-Rx Pharmaceuticals, Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 55289-205_054432e2-cfe5-4155-8a74-4f22289e552e 55289-205 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20090630 NDA NDA021774 PD-Rx Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55289-206_c130a37b-1944-4927-975c-9926cc3a60f8 55289-206 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 19951130 ANDA ANDA064071 PD-Rx Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 250 mg/1 55289-207_40d8d8b1-041e-4aa6-90b7-7239b42fd36b 55289-207 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 19951130 ANDA ANDA064071 PD-Rx Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 55289-211_91657336-9ef6-4a1b-a2f0-c5c11d0ef9c5 55289-211 HUMAN PRESCRIPTION DRUG GLUCOPHAGE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20090601 NDA NDA020357 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 55289-213_ec5e3fae-a70f-42aa-8ad0-1615a3a5403d 55289-213 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 PD-Rx Pharmaceuticals, Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 55289-214_286e83b4-0ce4-4fe6-bf6e-8f5b9ccca1f6 55289-214 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 PD-Rx Pharmaceuticals, Inc. PREGABALIN 150 mg/1 CV 55289-217_c11524d5-6394-42e2-a3d8-eb14e316d651 55289-217 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 PD-Rx Pharmaceuticals, Inc. ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55289-218_c296d2de-ea1a-4ee4-bdf1-44530b3c91fa 55289-218 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20080825 ANDA ANDA077419 PD-Rx Pharmaceuticals, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55289-221_b10cc4d2-f7b8-4693-94a0-f6e15123e91b 55289-221 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 19970528 ANDA ANDA040195 PD-Rx Pharmaceuticals, Inc. ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 55289-223_b2af33bd-d84c-45e9-ad52-c4a892d9afa1 55289-223 HUMAN PRESCRIPTION DRUG TRAZODONE TRAZODONE HYDROCHLORIDE TABLET ORAL 20100101 ANDA ANDA071524 PD-Rx Pharmaceuticals, Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 55289-224_87495c7f-e416-4930-bb4d-37438c991b5b 55289-224 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20101213 ANDA ANDA040185 PD-Rx Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55289-226_a4f6fd0c-5db4-490b-8d48-fbb8d11a5382 55289-226 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 55289-227_7f2782bc-c013-458d-915c-ad6e384a2b06 55289-227 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 PD-Rx Pharmaceuticals, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55289-228_f50b442d-712b-492b-adce-eb1bcfb1de5a 55289-228 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 PD-Rx Pharmaceuticals, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55289-233_7b5f4e76-1cbd-493b-a6d6-653800d56d22 55289-233 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070176 PD-Rx Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55289-234_daaf8cc1-ce2e-4451-a902-c9ce0e26a3ef 55289-234 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 PD-Rx Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55289-236_7d9249cd-a91f-47ea-bf81-dfae25b71b9e 55289-236 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA073144 PD-Rx Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55289-238_7ee57ff2-35d1-4e9c-88aa-3287e709c280 55289-238 HUMAN PRESCRIPTION DRUG COZAAR losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 PD-Rx Pharmaceuticals, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55289-239_66db0a82-7369-4976-b8b2-651919d663cc 55289-239 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, COATED ORAL 19970411 ANDA ANDA074903 PD-Rx Pharmaceuticals, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-241_6ca54aa0-647b-4253-8cbc-167a982e83e7 55289-241 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100225 ANDA ANDA076899 PD-Rx Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 55289-248_7a5b6716-9e18-40a9-a5dd-0cef6c8859a8 55289-248 HUMAN PRESCRIPTION DRUG Cytotec misoprostol TABLET ORAL 19861227 NDA NDA019268 PD-Rx Pharmaceuticals, Inc. MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 55289-251_3d5c121e-7ee0-4b3e-bbf1-24dcc2f820dd 55289-251 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 PD-Rx Pharmaceuticals, Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] 55289-255_9adfd59f-f7d4-449a-847e-0e55bfd08bb9 55289-255 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 PD-Rx Pharmaceuticals, Inc. PREGABALIN 300 mg/1 CV 55289-257_9e115917-1f3b-4432-beff-c387ed048598 55289-257 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 PD-Rx Pharmaceuticals, Inc. PREGABALIN 100 mg/1 CV 55289-258_f1aa17b3-43c4-4bc8-8fe7-705cf1d23e4b 55289-258 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20110504 ANDA ANDA070791 PD-Rx Pharmaceuticals, Inc. DOXEPIN HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 55289-261_6ed9395f-a24e-42c0-be44-e7c1e70b0d2f 55289-261 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. THYROID, PORCINE 60 mg/1 55289-265_e8b9fc5c-6a23-4b51-a29e-06bd975aa7c9 55289-265 HUMAN PRESCRIPTION DRUG Tolazamide tolazamide TABLET ORAL 20100105 ANDA ANDA070259 PD-Rx Pharmaceuticals, Inc. TOLAZAMIDE 250 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55289-266_143d87a6-a5a9-4db9-8c57-650b055b491c 55289-266 HUMAN PRESCRIPTION DRUG Evista Raloxifene hydrochloride TABLET ORAL 19980106 NDA NDA020815 PD-Rx Pharmaceuticals, Inc. RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 55289-270_aab1bc70-8260-47b7-8d6d-0fb6cc3c2a0e 55289-270 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100621 ANDA ANDA078477 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55289-272_8733e260-dcc2-4b0e-9ef2-f125fd6fb936 55289-272 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 PD-Rx Pharmaceuticals, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-273_be785a76-3583-4dfa-8158-fe9b28e6f629 55289-273 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 19970423 ANDA ANDA074578 PD-Rx Pharmaceuticals, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55289-274_153f08ef-12e0-4e2d-ad54-31c154f25d1b 55289-274 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065405 PD-Rx Pharmaceuticals, Inc. AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55289-275_dea8d004-c77e-4590-b02a-2350c01859f7 55289-275 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20100924 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. SALSALATE 500 mg/1 55289-277_25ed9955-a8da-4448-93ff-ec91df905548 55289-277 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 PD-Rx Pharmaceuticals, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55289-280_aa4e4c4d-866e-4e60-9ddb-56e58e7e2b31 55289-280 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 PD-Rx Pharmaceuticals, Inc. EZETIMIBE; SIMVASTATIN 10; 40 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55289-281_3328daeb-ef5d-4b40-b913-f1308ab05616 55289-281 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20110103 ANDA ANDA076345 PD-Rx Pharmaceuticals, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 55289-287_50b519a2-e6ff-4bc7-a8e3-516e0c7620db 55289-287 HUMAN PRESCRIPTION DRUG Ketoprofen ketoprofen CAPSULE ORAL 20100420 ANDA ANDA074035 PD-Rx Pharmaceuticals, Inc. KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-292_8fbdaeab-73d8-42e7-ae73-0934344a6979 55289-292 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 19961101 NDA NDA018333 PD-Rx Pharmaceuticals, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 55289-293_35b6bc8f-8b85-454e-82c8-1dd928831ffc 55289-293 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20110613 ANDA ANDA076052 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55289-297_4094b8da-6e28-4340-8bc4-7f325b57b2a0 55289-297 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 PD-Rx Pharmaceuticals, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-298_f3bee414-778f-4eba-9a9b-fc53a4cfafae 55289-298 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 PD-Rx Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-299_1be8006b-e34a-4c99-b70c-94a65b303bd9 55289-299 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 19920731 NDA AUTHORIZED GENERIC NDA019787 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55289-301_e031250f-e47e-484c-a2b1-f84fadfcdae3 55289-301 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031107 ANDA ANDA076467 PD-Rx Pharmaceuticals, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55289-302_65c1498f-77ea-4102-95b5-40a3fce4d2f2 55289-302 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate CAPSULE, EXTENDED RELEASE ORAL 19770906 NDA NDA018074 PD-Rx Pharmaceuticals, Inc. PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 55289-306_fbe44827-e718-4224-93ee-f2f6af831e05 55289-306 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 ANDA ANDA075896 PD-Rx Pharmaceuticals, Inc. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55289-307_f84c2f78-7cdc-4d0a-aba5-41eec0727f1f 55289-307 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 20100923 ANDA ANDA075227 PD-Rx Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-310_68a7bfa6-20e9-429e-b216-1d44c8a328c6 55289-310 HUMAN PRESCRIPTION DRUG Zithromax azithromycin TABLET, FILM COATED ORAL 19960718 NDA NDA050711 PD-Rx Pharmaceuticals, Inc. AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55289-313_0f180cd3-c1d4-4595-b846-4e64a7bfbbfa 55289-313 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20031023 ANDA ANDA040525 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 55289-315_21507865-8dc8-4f5a-83af-f5ef720f34f3 55289-315 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20110923 ANDA ANDA073192 PD-Rx Pharmaceuticals, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 55289-319_1e6ba5d7-f9d2-4673-b774-f0cc15ec99ef 55289-319 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 PD-Rx Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55289-324_743dc15f-c4b7-472d-91f0-15a64f8a5086 55289-324 HUMAN PRESCRIPTION DRUG Propoxyphene Propoxyphene Hydrochloride CAPSULE ORAL 19730620 ANDA ANDA083501 PD-Rx Pharmaceuticals, Inc. PROPOXYPHENE HYDROCHLORIDE 65 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 55289-328_e02e81ac-3c13-4aa1-9777-8cb6ddc1a3ea 55289-328 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20100915 ANDA ANDA074761 PD-Rx Pharmaceuticals, Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-329_8be27923-4b7b-4769-b908-adfe82e6dcde 55289-329 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20111110 ANDA ANDA072838 PD-Rx Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55289-330_7d955de0-43e7-4632-970d-9cfbb78a1b6f 55289-330 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA084122 PD-Rx Pharmaceuticals, Inc. PREDNISONE 10 mg/1 55289-334_91f9565e-dca8-44f3-8f9e-d352d2ff182f 55289-334 HUMAN PRESCRIPTION DRUG Fenoprofen Calcium Fenoprofen Calcium TABLET, FILM COATED ORAL 20091123 ANDA ANDA072267 PD-Rx Pharmaceuticals, Inc. FENOPROFEN CALCIUM 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-335_68567172-9931-4e3d-9676-9f82ff0a5a5a 55289-335 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20111110 ANDA ANDA072838 PD-Rx Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55289-337_23b8c68c-4c5a-474b-bbda-65131aeeacc7 55289-337 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20030201 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. PHENOBARBITAL 32.4 mg/1 CIV 55289-338_7187d594-ef1c-4583-a96a-4a371cd7f8cc 55289-338 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55289-340_c1180285-529b-462f-a467-9ea1a4c66135 55289-340 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 PD-Rx Pharmaceuticals, Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55289-344_19dfd52b-35b7-4cf5-bd93-7ce7f040a177 55289-344 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 PD-Rx Pharmaceuticals, Inc. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55289-354_83bc63a9-7ba3-469f-95ba-cd0bbc9fbfe8 55289-354 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA086183 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 55289-359_fe6feeec-5e1e-4456-b1c9-55bb425f2c61 55289-359 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020410 ANDA ANDA075604 PD-Rx Pharmaceuticals, Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55289-367_26f6e547-eee7-4407-9696-7f7102776176 55289-367 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 PD-Rx Pharmaceuticals, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-368_64a47533-efbd-4bf5-b338-4359debfa662 55289-368 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride Controlled-Release Diethylpropion Hydrochloride TABLET ORAL 20080101 NDA NDA011722 PD-Rx Pharmaceuticals, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 55289-370_8438b307-82f8-406a-a32e-d0c8a41527f7 55289-370 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20110504 ANDA ANDA070791 PD-Rx Pharmaceuticals, Inc. DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 55289-373_d2cfa5d5-37ad-4e41-b8a2-0b04a172501d 55289-373 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 PD-Rx Pharmaceuticals, Inc. PREDNISONE 5 mg/1 55289-376_812ce863-c4b3-46ea-ba49-8db7c989fa03 55289-376 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20090701 ANDA ANDA077923 PD-Rx Pharmaceuticals, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-379_e32b8558-2eb3-4065-a2aa-b433feacd47b 55289-379 HUMAN PRESCRIPTION DRUG Adipex-P Phentermine Hydrochloride TABLET ORAL 20110214 ANDA ANDA085128 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 55289-381_5aa82e99-91bf-4a3e-a87c-98bf2d732fb9 55289-381 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA AUTHORIZED GENERIC NDA019839 PD-Rx Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55289-382_be37e9c8-510d-41bc-a703-c6dc8bd78322 55289-382 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20110504 ANDA ANDA076704 PD-Rx Pharmaceuticals, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55289-384_3eb7a30b-f391-4d93-84b6-edc4e5f9aeb9 55289-384 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 55289-385_6ae85072-26f4-4a1e-9620-856ccb1debe7 55289-385 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 PD-Rx Pharmaceuticals, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55289-390_86202c09-2bc0-48ae-b5c6-5de6b1dd0283 55289-390 HUMAN PRESCRIPTION DRUG Vantin cefpodoxime proxetil TABLET, FILM COATED ORAL 19910829 NDA NDA050674 PD-Rx Pharmaceuticals, Inc. CEFPODOXIME PROXETIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55289-393_17f458db-7101-4f9b-af7e-6cdba41b4c52 55289-393 HUMAN PRESCRIPTION DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED ORAL 20070611 ANDA ANDA065370 PD-Rx Pharmaceuticals, Inc. CEFPODOXIME PROXETIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55289-394_8459ada8-9354-457b-952b-91dcc23ed148 55289-394 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55289-395_f3e03879-bdec-4cfa-9146-c1d586f84b2b 55289-395 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20110613 ANDA ANDA076052 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55289-399_b229bbb2-084d-4980-97c8-57a571551ecd 55289-399 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 PD-Rx Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55289-402_5ca4d95d-5e49-4de4-9d79-5eb0329666e5 55289-402 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072926 PD-Rx Pharmaceuticals, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-403_94326c04-9c9c-41c4-a593-d6fa85898d8f 55289-403 HUMAN PRESCRIPTION DRUG Comfort Pac With Cyclobenzaprine Cyclobenzaprine Hydrochloride KIT 20130715 ANDA ANDA078218 PD-Rx Pharmaceuticals, Inc. 55289-405_5f443361-0a14-4ce2-b177-8254d59f57e4 55289-405 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20070125 ANDA ANDA065352 PD-Rx Pharmaceuticals, Inc. CEFADROXIL 500 mg/1 55289-406_2bc3bb5a-a17d-41bf-9361-40218c4dab78 55289-406 HUMAN PRESCRIPTION DRUG ARTHROTEC diclofenac sodium and misoprostol TABLET, FILM COATED ORAL 19971224 NDA NDA020607 PD-Rx Pharmaceuticals, Inc. DICLOFENAC SODIUM; MISOPROSTOL 50; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 55289-409_fb6abe78-b96a-403e-84c2-43e825a233b8 55289-409 HUMAN PRESCRIPTION DRUG Zoloft sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA NDA019839 PD-Rx Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55289-410_0d04286f-3e06-4a2b-9191-8e0530eb8137 55289-410 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 19950117 NDA NDA020241 PD-Rx Pharmaceuticals, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55289-411_2a3a4d29-b781-486d-b704-6bd865c3bdf1 55289-411 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20110817 ANDA ANDA074270 PD-Rx Pharmaceuticals, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 55289-413_4eec32c6-ad39-4f75-97ad-06800b5067bb 55289-413 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19940527 ANDA ANDA074217 PD-Rx Pharmaceuticals, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55289-418_72719b52-c80b-476c-9171-f6b63436cc3d 55289-418 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, COATED ORAL 19990419 ANDA ANDA074903 PD-Rx Pharmaceuticals, Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-419_b770ce19-cfc3-44a0-8f29-39685282d702 55289-419 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20101210 ANDA ANDA076578 PD-Rx Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55289-432_39c90585-cc8c-4eac-a4f2-eb24737fbf65 55289-432 HUMAN PRESCRIPTION DRUG DIDREX benzphetamine hydrochloride TABLET ORAL 19601026 NDA NDA012427 PD-Rx Pharmaceuticals, Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 55289-433_843d6b92-e1ae-409f-b1e5-a2f2e03fe719 55289-433 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55289-436_2c185d0e-03f3-4477-a4d4-545afd0f2654 55289-436 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 PD-Rx Pharmaceuticals, Inc. OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55289-441_d44d2240-9877-4f62-b412-29bb87fb7934 55289-441 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 19910731 ANDA ANDA063083 PD-Rx Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 55289-443_4b6c5d9b-6b2f-4900-b83b-65894da272d9 55289-443 HUMAN PRESCRIPTION DRUG Benicar HCT olmesartan medoxomil-hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55289-444_965c00dc-a510-41a1-802c-046ba7fe2a29 55289-444 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 PD-Rx Pharmaceuticals, Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55289-445_2e449159-c410-4857-a4f4-e84abc8328c6 55289-445 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040114 ANDA ANDA076494 PD-Rx Pharmaceuticals, Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-447_da2d8781-2841-4251-93b8-88cfa878a413 55289-447 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 19971001 NDA NDA020639 PD-Rx Pharmaceuticals, Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 55289-448_24815b5a-5078-4528-a7a0-404aec8d6097 55289-448 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 19920731 NDA AUTHORIZED GENERIC NDA019787 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55289-449_36e3e747-164d-40e6-80ab-b3fd2c05ef4e 55289-449 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089990 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 55289-451_cbaca5da-f265-4dc9-a233-7dc324b4d068 55289-451 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 PD-Rx Pharmaceuticals, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-453_c0ba0355-ff68-4459-bf42-c2dec49d49b3 55289-453 HUMAN PRESCRIPTION DRUG Daypro oxaprozin TABLET, FILM COATED ORAL 19921029 NDA NDA018841 PD-Rx Pharmaceuticals, Inc. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-457_e68533f6-9945-42be-9c0d-004ddaa60989 55289-457 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100225 ANDA ANDA076899 PD-Rx Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 55289-460_84f12f90-043b-4a72-bc18-782d628a0c29 55289-460 HUMAN PRESCRIPTION DRUG Diflunisal Diflunisal TABLET, FILM COATED ORAL 20100820 ANDA ANDA073673 PD-Rx Pharmaceuticals, Inc. DIFLUNISAL 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-462_3967baee-0170-45e7-8c76-a500769add81 55289-462 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20111207 ANDA ANDA074556 PD-Rx Pharmaceuticals, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55289-463_6a70f987-22d3-49b3-817b-9ba877216895 55289-463 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 PD-Rx Pharmaceuticals, Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 55289-464_0b075e21-f330-4471-b37b-4bef4100ad0e 55289-464 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20080212 ANDA ANDA040724 PD-Rx Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55289-465_93a7fcb6-20f4-4a33-8a5b-a96fb9a6288b 55289-465 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 PD-Rx Pharmaceuticals, Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 55289-466_81af72b3-eefd-4905-9e87-2822d3877de5 55289-466 HUMAN PRESCRIPTION DRUG Comfort Pac with Naproxen Naproxen KIT 20100218 ANDA ANDA075927 PD-Rx Pharmaceuticals, Inc. 55289-467_cc5c7b37-2fb4-4cc9-8693-0a86c6649543 55289-467 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070801 ANDA ANDA078314 PD-Rx Pharmaceuticals, Inc. NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-470_1dd70861-024e-4cc9-a700-59b274b58a0f 55289-470 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 19971001 NDA NDA020658 PD-Rx Pharmaceuticals, Inc. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55289-473_7f32f730-264c-4d55-9141-f25fbd0d54da 55289-473 HUMAN PRESCRIPTION DRUG PEPCID famotidine TABLET, FILM COATED ORAL 19861015 NDA NDA019462 PD-Rx Pharmaceuticals, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55289-475_4800412d-3d31-441f-a9e7-01cff14a7ec1 55289-475 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 PD-Rx Pharmaceuticals, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-477_1d78c735-d117-4e02-a7ba-fecaa8e91adc 55289-477 HUMAN PRESCRIPTION DRUG VIRACEPT nelfinavir mesylate TABLET, FILM COATED ORAL 19970314 NDA NDA020779 PD-Rx Pharmaceuticals, Inc. NELFINAVIR MESYLATE 250 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 55289-481_e1d1e1da-81dc-4fb1-a9af-8d8d5af67a34 55289-481 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED ORAL 20110504 ANDA ANDA071483 PD-Rx Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55289-487_ad80a9a9-0602-4852-8413-18c389be7701 55289-487 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 PD-Rx Pharmaceuticals, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-488_c6140a98-8fc4-47cb-826c-5dbabda2bd67 55289-488 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA071851 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55289-491_dd94a89e-765b-49b8-8998-684440fa5211 55289-491 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 PD-Rx Pharmaceuticals, Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 55289-492_91eb0a06-4632-41ee-8784-2709c29cf3a4 55289-492 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091202 ANDA ANDA040625 PD-Rx Pharmaceuticals, Inc. FOLIC ACID 1 mg/1 55289-501_3026c80c-e686-4c33-b7a3-661c447e7bf5 55289-501 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980430 ANDA ANDA075078 PD-Rx Pharmaceuticals, Inc. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-502_c06e3de5-7abc-4d6e-97cf-9e833b7624bf 55289-502 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19841107 ANDA ANDA062396 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 50 mg/1 55289-505_de28c9e4-2afb-416f-9551-a648475fcd62 55289-505 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20091106 ANDA ANDA075165 PD-Rx Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55289-507_d781b02d-dc89-410d-a095-7cccf45b5fc6 55289-507 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 PD-Rx Pharmaceuticals, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 55289-511_944ac03a-f283-48d1-967a-1ba7cf90d340 55289-511 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20070131 ANDA ANDA077712 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55289-519_eeb1dc58-1096-4f40-99cd-757112df3608 55289-519 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 PD-Rx Pharmaceuticals, Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 55289-520_ffbb58f5-69ec-4fb4-9f64-8e34e560f938 55289-520 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 PD-Rx Pharmaceuticals, Inc. EZETIMIBE; SIMVASTATIN 10; 80 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55289-521_761fccfc-38d9-4910-96e0-fe260b2de457 55289-521 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070033 PD-Rx Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 55289-522_4aad699e-f985-4a2c-8615-74b14c0cbf2f 55289-522 HUMAN PRESCRIPTION DRUG HYZAAR losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55289-523_f666a739-fe1e-42ed-befc-5fd758afd859 55289-523 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100101 ANDA ANDA040736 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-524_3c4082c1-1821-4ba1-82c0-1a63ede0af5b 55289-524 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 PD-Rx Pharmaceuticals, Inc. SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 55289-525_8c1e09a7-485b-4572-aea4-b035b57484f6 55289-525 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 PD-Rx Pharmaceuticals, Inc. ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55289-531_deb46e03-d889-48ef-a956-a7f81ec96a9c 55289-531 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20080520 ANDA ANDA040791 PD-Rx Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55289-559_1a18e223-c3cc-4a96-98d7-648ff5c3ea21 55289-559 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 PD-Rx Pharmaceuticals, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55289-561_d1de2cea-0afb-44a3-b23d-2ba39a68dfff 55289-561 HUMAN PRESCRIPTION DRUG Flurbiprofen flurbiprofen TABLET, FILM COATED ORAL 20110520 ANDA ANDA074358 PD-Rx Pharmaceuticals, Inc. FLURBIPROFEN 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-562_ea06c15f-c725-4b4d-a471-db44b4d2c949 55289-562 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970829 ANDA ANDA074979 PD-Rx Pharmaceuticals, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-565_ebe5f356-8882-4568-bd32-2506c63c7667 55289-565 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 19961227 NDA AUTHORIZED GENERIC NDA020504 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55289-567_3e08af89-92f3-4b9e-807d-77cd2b00bd38 55289-567 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100218 ANDA ANDA078218 PD-Rx Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55289-568_c4e1af62-0e83-42a6-b7ee-e3599e877c5e 55289-568 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20101213 ANDA ANDA040185 PD-Rx Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55289-569_b0aa4eac-a4a3-441a-8bda-7cceea21bf05 55289-569 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 PD-Rx Pharmaceuticals, Inc. PREGABALIN 75 mg/1 CV 55289-577_abe331de-ae75-4593-9ee6-87878fe5ed1a 55289-577 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 PD-Rx Pharmaceuticals, Inc. SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 55289-581_b1270af1-47f9-4339-8046-74b3dbc0c0ec 55289-581 HUMAN PRESCRIPTION DRUG Cimetidine cimetidine TABLET, FILM COATED ORAL 20110504 ANDA ANDA074246 PD-Rx Pharmaceuticals, Inc. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55289-582_1109916e-5820-4841-82c8-0a514ea867d6 55289-582 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 PD-Rx Pharmaceuticals, Inc. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55289-586_665fecc4-13a1-45ca-8bcc-e28991818b11 55289-586 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073553 PD-Rx Pharmaceuticals, Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 55289-589_1b6c803a-200d-4128-bcf3-16740da18f34 55289-589 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20100921 ANDA ANDA065282 PD-Rx Pharmaceuticals, Inc. CEFADROXIL 500 mg/1 55289-590_430d558c-ab72-43cc-8fad-4265a84ba73e 55289-590 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 PD-Rx Pharmaceuticals, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-591_f0918bea-e8cf-48b5-8325-6595895a8082 55289-591 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 PD-Rx Pharmaceuticals, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55289-592_10bd19e1-f40d-4e11-a8a3-a45ee01637b9 55289-592 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 20110120 ANDA ANDA062286 PD-Rx Pharmaceuticals, Inc. DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55289-593_351f9ab7-97d7-4b82-b05e-833ab63d57be 55289-593 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 PD-Rx Pharmaceuticals, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 55289-594_ffe52cc5-ab95-4066-b343-ab4d153b4557 55289-594 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072928 PD-Rx Pharmaceuticals, Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-599_3603d8fb-be09-4f68-8773-a8bb1589c975 55289-599 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 PD-Rx Pharmaceuticals, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-600_8b81aa7d-fadb-42cb-88c8-bf8511184047 55289-600 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20111027 ANDA ANDA075509 PD-Rx Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55289-601_ee6f1eb4-b99e-4acb-b895-a9fd5d492984 55289-601 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20100908 ANDA ANDA075849 PD-Rx Pharmaceuticals, Inc. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-603_fae4231c-d54a-4195-ab1c-ff89cf21e856 55289-603 HUMAN PRESCRIPTION DRUG Estradiol estradiol TABLET ORAL 20091217 ANDA ANDA040326 PD-Rx Pharmaceuticals, Inc. ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 55289-606_adbb432d-4ad3-4799-ace5-a6b840899e76 55289-606 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19840501 NDA AUTHORIZED GENERIC NDA017532 PD-Rx Pharmaceuticals, Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55289-607_60ccad90-0ddf-4059-8d74-9f17b2332e2b 55289-607 HUMAN PRESCRIPTION DRUG Verapamil Verapamil TABLET, EXTENDED RELEASE ORAL 20110805 ANDA ANDA090700 PD-Rx Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55289-609_1060b26b-6301-4c84-a293-4db033c5fac0 55289-609 HUMAN PRESCRIPTION DRUG Nabumetone Nabumentone TABLET ORAL 20020225 ANDA ANDA075280 PD-Rx Pharmaceuticals, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-610_892fcbd0-5f60-4043-829c-04e1dbc806bc 55289-610 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20020129 ANDA ANDA075049 PD-Rx Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55289-611_2d9c4588-34fc-4fdc-93b6-e6ec60e73c73 55289-611 HUMAN PRESCRIPTION DRUG Nabumetone Nabumentone TABLET ORAL 20020225 ANDA ANDA075280 PD-Rx Pharmaceuticals, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-612_9b828ba0-e671-4940-ac00-554268d6ab02 55289-612 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride TABLET ORAL 19970101 NDA NDA020397 PD-Rx Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55289-613_4cf804ee-9b84-4acf-9298-3a96df94536a 55289-613 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20021015 ANDA ANDA075465 PD-Rx Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55289-615_cea40333-9456-49cd-b19c-eb1a8bab7b99 55289-615 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20100727 ANDA ANDA075978 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 55289-617_c0dcac73-8295-4639-94f6-a9aa838abb78 55289-617 HUMAN PRESCRIPTION DRUG ULTRACET tramadol hydrochloride and acetaminophen TABLET, COATED ORAL 20010815 NDA NDA021123 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 55289-618_ef897717-96d4-4e41-aa00-01b3ee5f2f67 55289-618 HUMAN PRESCRIPTION DRUG Mobic meloxicam TABLET ORAL 20000601 NDA NDA020938 PD-Rx Pharmaceuticals, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-624_b93cfd9a-656f-4b32-9926-1f41c8fd45f1 55289-624 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040875 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 55289-626_faf6e3f7-9ae2-4541-8381-3bddcb3f102f 55289-626 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 PD-Rx Pharmaceuticals, Inc. DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 55289-629_a026b4ba-b7e8-4f53-ba73-c93e7e571b87 55289-629 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20111207 ANDA ANDA074556 PD-Rx Pharmaceuticals, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55289-638_f75c764e-1ebe-40c8-843b-d562dc667e82 55289-638 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20051117 ANDA ANDA077321 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55289-640_65daea3d-0608-4d18-8066-b813d325f474 55289-640 HUMAN PRESCRIPTION DRUG misoprostol misoprostol TABLET ORAL 20091227 NDA NDA019268 PD-Rx Pharmaceuticals, Inc. MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 55289-650_42e700ad-c1cd-4b6f-abc3-99b8bcc55d34 55289-650 HUMAN PRESCRIPTION DRUG ULTRAM tramadol hydrochloride TABLET, COATED ORAL 19950303 NDA NDA020281 PD-Rx Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 55289-653_09e450f8-5e95-4952-8f51-afb86b181bd5 55289-653 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 PD-Rx Pharmaceuticals, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55289-660_1513773e-223a-4ffa-a37a-cf91dad6bf35 55289-660 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 PD-Rx Pharmaceuticals, Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-663_a08ebf5b-4c33-4191-bc46-2925d7c4957c 55289-663 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 20100915 NDA NDA070624 PD-Rx Pharmaceuticals, Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-670_256dac0a-62f9-44f6-9581-2f7a095933be 55289-670 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20100301 ANDA ANDA090200 PD-Rx Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55289-692_e29f8a72-28d9-4908-bcd2-eabadc5a3a02 55289-692 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20071101 ANDA ANDA078296 PD-Rx Pharmaceuticals, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55289-694_8c005e3c-d3bb-4848-8938-d28791f0d1b2 55289-694 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 PD-Rx Pharmaceuticals, Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55289-696_46c6a8b2-3e78-4541-a9e2-c0b20f5f2f5d 55289-696 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 55289-697_d4921603-1e6a-4445-a90b-2f9860f4960e 55289-697 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 PD-Rx Pharmaceuticals, Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55289-701_fd896d7d-6d31-4738-b7df-e1f2b0427621 55289-701 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040527 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 55289-704_1e019e5f-f578-47a2-b9a7-7b94d0951ea0 55289-704 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole CAPSULE, DELAYED RELEASE ORAL 19950510 NDA NDA020406 PD-Rx Pharmaceuticals, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55289-707_1136c38c-ce25-4630-a55d-f2150b428552 55289-707 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20060329 ANDA ANDA065255 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55289-708_083386a4-27e0-4687-aff1-59ee71b51353 55289-708 HUMAN PRESCRIPTION DRUG Methergine methylergonovine maleate TABLET, COATED ORAL 19461119 NDA NDA006035 PD-Rx Pharmaceuticals, Inc. METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 55289-711_46312736-1f61-41a0-821e-11a9b3830e7d 55289-711 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55289-711_880f99c9-11d6-41dd-a33a-de90a45cb707 55289-711 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 55289-719_31423242-8d35-4c75-97b7-c2fae870c35a 55289-719 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 PD-Rx Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 55289-720_9ef5a053-6d72-4c5f-b5b4-daacb09b5e00 55289-720 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 19970528 ANDA ANDA040195 PD-Rx Pharmaceuticals, Inc. ACETAZOLAMIDE 125 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 55289-723_2ea9bff1-fb84-4fe2-aaaf-118a3f9967a2 55289-723 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090917 ANDA ANDA078906 PD-Rx Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55289-725_a637fc47-0120-4284-a109-a8bbb54e2470 55289-725 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 19910731 ANDA ANDA073191 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55289-730_ac9bd42c-f2c7-44aa-a993-abb4f9f02b56 55289-730 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 PD-Rx Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 55289-733_7c72ec0f-ed70-42c6-a46f-f4281e622895 55289-733 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100201 ANDA ANDA075491 PD-Rx Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 55289-736_dfbd8414-5c5a-4bb4-bb40-d6dcb52070bb 55289-736 HUMAN PRESCRIPTION DRUG SKELAXIN metaxalone TABLET ORAL 20020830 NDA NDA013217 PD-Rx Pharmaceuticals, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55289-737_c9fbd121-6d91-45aa-8030-f6e4f227a652 55289-737 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040746 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 55289-738_e0c2e107-e3c0-4f82-aab3-a027496b0e58 55289-738 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20040818 ANDA ANDA076368 PD-Rx Pharmaceuticals, Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55289-747_01cd7235-7d8e-4ffc-9ba5-727db6d81bfb 55289-747 HUMAN PRESCRIPTION DRUG MALARONE atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20000726 NDA NDA021078 PD-Rx Pharmaceuticals, Inc. ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 55289-757_4ae700f5-39e0-4326-9623-22f56b9c8596 55289-757 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100715 ANDA ANDA072234 PD-Rx Pharmaceuticals, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 55289-761_062deff6-aba2-491a-8c5d-23eec91b70e5 55289-761 HUMAN PRESCRIPTION DRUG Estradiol estradiol TABLET ORAL 20091217 ANDA ANDA040326 PD-Rx Pharmaceuticals, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 55289-765_47b180d6-446a-44e9-987a-339506efdce1 55289-765 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20110211 ANDA ANDA075511 PD-Rx Pharmaceuticals, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55289-767_026d4aea-64b3-4363-882c-4e8bd0ab7ebf 55289-767 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20110125 ANDA ANDA065096 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 55289-768_3621c054-7f7d-481f-ab94-2b1c3b5fe340 55289-768 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 PD-Rx Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55289-773_aa888578-3bb8-401b-bc17-d9ecfa7c3e9a 55289-773 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20100329 ANDA ANDA040145 PD-Rx Pharmaceuticals, Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55289-779_7c960ed6-7aa8-44f4-adfc-62944d79b1fd 55289-779 HUMAN PRESCRIPTION DRUG GlipizideER ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031101 ANDA ANDA076467 PD-Rx Pharmaceuticals, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55289-781_55189d06-74d5-43f9-ac5c-84d15af5afdc 55289-781 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19981120 ANDA ANDA075229 PD-Rx Pharmaceuticals, Inc. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-784_0e3469e5-e54b-4484-93fd-5ae2160cb199 55289-784 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride TABLET ORAL 20020627 ANDA ANDA076280 PD-Rx Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55289-787_a9169ab1-bacb-4504-a063-54bb493e129f 55289-787 HUMAN PRESCRIPTION DRUG Triazolam triazolam TABLET ORAL 19821115 NDA AUTHORIZED GENERIC NDA017892 PD-Rx Pharmaceuticals, Inc. TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-791_9022beca-164e-4806-b4ee-720c88b27eda 55289-791 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE ORAL 19970428 ANDA ANDA040886 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 55289-794_b9ba455c-a3a3-4280-8f8c-0e7927ce0beb 55289-794 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Immediate-Release Diethylpropion hydrochloride TABLET ORAL 20080101 ANDA ANDA011722 PD-Rx Pharmaceuticals, Inc. DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 55289-798_8926f3f4-f4eb-442c-b8bf-a76700e8ad27 55289-798 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 PD-Rx Pharmaceuticals, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55289-800_d6ff23b5-3bf8-444d-88c4-252a5c9efa26 55289-800 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium trihydrate TABLET, FILM COATED ORAL 19961217 NDA NDA020702 PD-Rx Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55289-802_f8437581-c3cb-4df2-acd2-29bb0cdd9514 55289-802 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20000912 ANDA ANDA040148 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 55289-806_edee3a53-03a6-41e4-bd52-c2630a61605e 55289-806 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 PD-Rx Pharmaceuticals, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55289-809_fec62b54-5d4a-4ea1-88aa-48ef7c584d69 55289-809 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride TABLET ORAL 20021126 ANDA ANDA076280 PD-Rx Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55289-814_c4f03844-4270-430e-b52b-1bb74a6aff3c 55289-814 HUMAN PRESCRIPTION DRUG DOLOPHINE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20100101 NDA NDA006134 PD-Rx Pharmaceuticals, Inc. METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55289-816_22395ffb-ac61-430a-860d-6263696598c6 55289-816 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE TABLET ORAL 19590603 NDA AUTHORIZED GENERIC NDA011839 PD-Rx Pharmaceuticals, Inc. MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 55289-817_cf438b80-ad50-4c52-b53a-7cff58f1b2e0 55289-817 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 PD-Rx Pharmaceuticals, Inc. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55289-820_eae9cabc-42e5-4542-a835-7def28cb899e 55289-820 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55289-821_8b9f904e-010d-4cf0-b824-c42233879f96 55289-821 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 PD-Rx Pharmaceuticals, Inc. CIPROFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55289-822_fc2b3dfb-29a8-42f1-88d8-342772aadc70 55289-822 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 PD-Rx Pharmaceuticals, Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 55289-823_c78fdb36-cb0c-46de-961b-0b86d02845a3 55289-823 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 PD-Rx Pharmaceuticals, Inc. CIPROFLOXACIN 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55289-824_03b39fc2-da1b-4941-b3c9-4d8f50f33c34 55289-824 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 PD-Rx Pharmaceuticals, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55289-825_d60c2d43-455b-423d-89ae-b5e916e25c8f 55289-825 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 PD-Rx Pharmaceuticals, Inc. VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55289-826_2dc52192-d601-49c1-90bc-39fce7d26ac3 55289-826 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 PD-Rx Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 55289-828_175b5c87-9e0c-4859-91af-31c87466cfb5 55289-828 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 PD-Rx Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55289-834_a7fb755e-884f-4d3e-bb40-5dffa158c360 55289-834 HUMAN PRESCRIPTION DRUG Propoxyphene Propoxyphene Hydrochloride CAPSULE ORAL 20100510 ANDA ANDA083501 PD-Rx Pharmaceuticals, Inc. PROPOXYPHENE HYDROCHLORIDE 65 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 55289-838_05eab10a-b142-4968-ab4e-22d641007f20 55289-838 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55289-845_9bebfaae-4613-4131-873a-e6e41975f9f8 55289-845 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20111116 ANDA ANDA065101 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 55289-853_2ff63d5b-0c0b-4d9a-b254-dc6288e94a0c 55289-853 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110908 ANDA ANDA075124 PD-Rx Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55289-856_f7d86f5b-6a8d-4205-873a-e24e75fb3ec7 55289-856 HUMAN PRESCRIPTION DRUG Chloroquine Chloroquine Phosphate TABLET, COATED ORAL 19990917 ANDA ANDA083082 PD-Rx Pharmaceuticals, Inc. CHLOROQUINE PHOSPHATE 500 mg/1 Antimalarial [EPC] 55289-858_cc03fb60-a9f8-4815-ae1d-5060145b253b 55289-858 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55289-861_4e91ddf5-b4d9-411e-bdb9-b1ed1843f689 55289-861 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium trihydrate TABLET, FILM COATED ORAL 19961217 NDA NDA020702 PD-Rx Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55289-866_07cca6d1-e8e2-4084-acac-076c833c8774 55289-866 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 55289-870_013c8f96-f8fb-4fcf-a8f3-56db1b65fcd0 55289-870 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium trihydrate TABLET, FILM COATED ORAL 19961217 NDA NDA020702 PD-Rx Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55289-872_4533c8b5-d919-45cb-9812-9c85a1e200d1 55289-872 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20110719 NDA NDA020639 PD-Rx Pharmaceuticals, Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 55289-876_1f1410bc-20e8-49a4-87a6-1ba65b88a62f 55289-876 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 PD-Rx Pharmaceuticals, Inc. VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55289-877_fc3d42a7-3a60-4f2f-9698-b8391fd21647 55289-877 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 PD-Rx Pharmaceuticals, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55289-878_3f6c04e9-787d-41f8-8546-2abe82174638 55289-878 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55289-879_d78773ba-affd-4817-b02e-b644e7ca4a28 55289-879 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030827 ANDA ANDA040511 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 55289-881_aca0444f-057e-48af-914c-153a5fdde538 55289-881 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20071101 ANDA ANDA078296 PD-Rx Pharmaceuticals, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55289-883_5a692c8f-ebd7-41b2-a616-c9d7bdf26a29 55289-883 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20041112 ANDA ANDA077032 PD-Rx Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55289-884_d2bdd627-e7fd-49c1-a44a-074fbb1e9551 55289-884 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20051117 ANDA ANDA077321 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 5 mg/1 55289-890_c27d4eda-bbe0-40be-864c-b73c00080066 55289-890 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20030318 ANDA ANDA063083 PD-Rx Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 55289-891_9cd3035f-5158-4afb-85dd-75c7c9383098 55289-891 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20100101 ANDA ANDA076636 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55289-892_145c5741-ddba-474a-a22a-bde3230476b0 55289-892 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20020806 ANDA ANDA076257 PD-Rx Pharmaceuticals, Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55289-895_0c32f9a4-0a75-46c2-96aa-81a6d7995486 55289-895 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 55289-898_d553ab4c-fa46-4e5b-b2b2-9448bfb7bbd5 55289-898 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55289-903_f4eb8615-b5d5-4bbd-84fe-8b799b68bd79 55289-903 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750603 ANDA ANDA084613 PD-Rx Pharmaceuticals, Inc. DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55289-906_2ce8c900-d7b9-404d-a719-f3b31071cb09 55289-906 HUMAN PRESCRIPTION DRUG EXTENDED PHENYTOIN SODIUM EXTENDED PHENYTOIN SODIUM CAPSULE ORAL 20080130 ANDA ANDA040732 PD-Rx Pharmaceuticals, Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55289-907_e463d14a-679b-4bac-b376-0e4c1e1f955d 55289-907 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE ORAL 20090811 ANDA ANDA072781 PD-Rx Pharmaceuticals, Inc. NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55289-909_d0ff08ec-2698-4ed9-b51f-206d95562d35 55289-909 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20060531 ANDA ANDA065266 PD-Rx Pharmaceuticals, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 55289-911_63e32205-ad24-4d80-b2d5-92792a92e10c 55289-911 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 19000101 NDA NDA020839 PD-Rx Pharmaceuticals, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 55289-912_fe54c574-0959-4275-82f6-2dbdda1c88e3 55289-912 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20070629 ANDA ANDA040808 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 55289-916_8e3594a1-8cc8-4a21-a92b-87aa2e164f1d 55289-916 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089828 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 55289-917_76037204-585c-45b9-8dce-45272b0af911 55289-917 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55289-919_d9f86521-921a-41ae-8239-bccd0c371c66 55289-919 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20100727 ANDA ANDA075978 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 55289-920_49dccc5e-30c4-45f7-ae87-995ab5388281 55289-920 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20091231 ANDA ANDA074215 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-924_e8d20301-1af3-4fca-9280-3dd9fbfa20d3 55289-924 HUMAN PRESCRIPTION DRUG METHOTREXATE METHOTREXATE TABLET ORAL 19531207 NDA NDA008085 PD-Rx Pharmaceuticals, Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 55289-926_a549c50a-0e1f-4b3e-ab30-9fd108a3afea 55289-926 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 19950801 NDA NDA020487 PD-Rx Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55289-928_539d3346-8547-4634-b677-8096742ff3f4 55289-928 HUMAN PRESCRIPTION DRUG PROMETHEGAN PROMETHAZINE HYDROCHLORIDE SUPPOSITORY RECTAL 20020228 ANDA ANDA040428 PD-Rx Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55289-930_df90cd3d-5fd2-414c-bc60-9da602e73d98 55289-930 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 19900403 ANDA ANDA071795 PD-Rx Pharmaceuticals, Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55289-932_088d6f75-5327-4aff-83d5-8ec245bf151e 55289-932 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 PD-Rx Pharmaceuticals, Inc. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55289-934_cb4606cd-b64e-4b37-9451-0492f7439c8f 55289-934 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 55289-935_f98d792c-d2c6-4f88-a5d0-3186c2b33061 55289-935 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 PD-Rx Pharmaceuticals, Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55289-937_d20f79cc-eb9b-41da-8175-d11c5766f2fa 55289-937 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20031016 NDA NDA021487 PD-Rx Pharmaceuticals, Inc. MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 55289-939_3e60998f-1589-4109-b04b-c9c64a8452db 55289-939 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55289-940_74f1687e-efbe-4f3b-b874-f550b02f8d23 55289-940 HUMAN PRESCRIPTION DRUG PHENADOZ Promethazine Hydrochloride SUPPOSITORY RECTAL 20030624 ANDA ANDA040479 PD-Rx Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55289-944_5646c207-b113-485a-bb9b-508fcb4817b5 55289-944 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 PD-Rx Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 55289-945_91418768-76a2-49b6-b18d-b95db7e85bae 55289-945 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20080925 ANDA ANDA078491 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-947_422cf00f-5b11-421a-b540-ae8efc359b1b 55289-947 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20100618 NDA NDA021906 PD-Rx Pharmaceuticals, Inc. LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA] 55289-951_99eaf85f-6b72-4650-824a-fe9a910aef9c 55289-951 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040777 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55289-954_52cb9eb3-86b8-4792-9339-3677d7f5adcc 55289-954 HUMAN PRESCRIPTION DRUG SUPRAX CEFIXIME TABLET ORAL 20080401 ANDA ANDA065130 PD-Rx Pharmaceuticals, Inc. CEFIXIME 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55289-957_c070c69a-9126-4f43-be51-bbb5e1013c48 55289-957 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20100521 ANDA ANDA077081 PD-Rx Pharmaceuticals, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 55289-959_32ec09ca-15cf-486e-a177-2b340067f3d1 55289-959 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55289-961_fb27173b-03c9-41ba-90af-68108334f0d2 55289-961 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, FILM COATED ORAL 19980220 NDA NDA020829 PD-Rx Pharmaceuticals, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 55289-962_13532ec0-88c2-444a-b1a2-435c18362417 55289-962 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20080925 ANDA ANDA078491 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55289-963_5e775423-473e-4b67-8a34-e5371ae72910 55289-963 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20110624 ANDA ANDA076211 PD-Rx Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55289-964_28c47d22-366c-4450-a5b3-9e47ef7430b8 55289-964 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 PD-Rx Pharmaceuticals, Inc. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55289-967_14d265ea-bc52-492e-9e5a-7678f41b715c 55289-967 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20100101 ANDA ANDA076636 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55289-969_f00b54b9-56db-448f-a351-81ac2594920e 55289-969 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 PD-Rx Pharmaceuticals, Inc. PREGABALIN 50 mg/1 CV 55289-970_3c81cdde-195d-4c96-b814-5696ba2301bb 55289-970 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20090903 ANDA ANDA070317 PD-Rx Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 55289-971_751d5b19-b4cb-43b6-a27a-f91fcafe8f1a 55289-971 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20021104 ANDA ANDA075410 PD-Rx Pharmaceuticals, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 55289-972_6ff95887-5f6d-42f1-bf50-fc7877a79fdd 55289-972 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 PD-Rx Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55289-976_64629923-d9fd-41f9-bf84-b97f187b5527 55289-976 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 PD-Rx Pharmaceuticals, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55289-984_78a82f90-12b6-4bb9-889d-7fdd68a21d59 55289-984 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 PD-Rx Pharmaceuticals, Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55289-989_6523ca0d-89b6-473b-84fd-2d8ff484ba97 55289-989 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 19980220 NDA NDA020830 PD-Rx Pharmaceuticals, Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 55289-993_2c1204f9-0fe3-45de-a508-ee73b7c6c0ec 55289-993 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 PD-Rx Pharmaceuticals, Inc. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55289-996_2d84aca5-acff-4f59-bfbe-8bdc38b217ff 55289-996 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 PD-Rx Pharmaceuticals, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 55289-997_1f0b4280-2f5d-4c13-8a4d-b8ac89166034 55289-997 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 55292-102_1ae91532-7784-290e-581d-4a32628d1135 55292-102 HUMAN PRESCRIPTION DRUG Desoxyn methamphetamine hydrochloride TABLET ORAL 19431231 NDA NDA005378 RECORDATI RARE DISEASES, INC. METHAMPHETAMINE HYDROCHLORIDE 5 mg/1 Amphetamine Anorectic [EPC],Amphetamines [Chemical/Ingredient],Appetite Suppression [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE] CII 55292-122_a9ac8d64-3eab-ad10-e157-44caef82bab6 55292-122 HUMAN PRESCRIPTION DRUG NeoProfen ibuprofen lysine SOLUTION INTRAVENOUS 20060413 NDA NDA021903 RECORDATI RARE DISEASES, INC. IBUPROFEN LYSINE 10 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55292-201_ce6a3eab-6d87-864a-a36c-8d74ebd8ced2 55292-201 HUMAN PRESCRIPTION DRUG Chemet succimer CAPSULE ORAL 20130821 NDA NDA019998 RECORDATI RARE DISEASES, INC. SUCCIMER 100 mg/1 Lead Chelating Activity [MoA],Lead Chelator [EPC] 55292-301_bd19117f-faca-e901-9b77-16934d81f754 55292-301 HUMAN PRESCRIPTION DRUG Tranxene T-Tab clorazepate dipotassium TABLET ORAL 19720623 NDA NDA017105 RECORDATI RARE DISEASES, INC. CLORAZEPATE DIPOTASSIUM 3.75 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55292-302_bd19117f-faca-e901-9b77-16934d81f754 55292-302 HUMAN PRESCRIPTION DRUG Tranxene T-Tab clorazepate dipotassium TABLET ORAL 19720623 NDA NDA017105 RECORDATI RARE DISEASES, INC. CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55292-303_bd19117f-faca-e901-9b77-16934d81f754 55292-303 HUMAN PRESCRIPTION DRUG Tranxene T-Tab clorazepate dipotassium TABLET ORAL 19720623 NDA NDA017105 RECORDATI RARE DISEASES, INC. CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55292-601_2f592069-8310-9c51-3813-a28e9d668e5f 55292-601 HUMAN PRESCRIPTION DRUG Peganone ethotoin TABLET ORAL 19570422 NDA NDA010841 RECORDATI RARE DISEASES, INC. ETHOTOIN 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55292-701_dc8bcfe4-0e09-2a08-801b-562928da8f0c 55292-701 HUMAN PRESCRIPTION DRUG Panhematin hemin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19830720 BLA BLA101246 RECORDATI RARE DISEASES, INC. HEMIN 7 mg/mL 55292-811_dcbf4425-ab68-edcf-9b16-3ac62668150d 55292-811 HUMAN PRESCRIPTION DRUG Cosmegen dactinomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19641210 NDA NDA050682 RECORDATI RARE DISEASES, INC. DACTINOMYCIN .5 mg/mL Actinomycin [EPC],Nucleic Acid Synthesis Inhibitors [MoA],Protein Synthesis Inhibitors [MoA] 55292-911_f403750e-2b49-9dc7-8139-7563864ac611 55292-911 HUMAN PRESCRIPTION DRUG Mustargen mechlorethamine hydrochloride POWDER, FOR SOLUTION INTRACAVITARY; INTRAVENOUS 19490315 NDA NDA006695 RECORDATI RARE DISEASES, INC. MECHLORETHAMINE HYDROCHLORIDE 10 mg/10mL Alkylating Activity [MoA],Alkylating Drug [EPC] 55298-013_8e9a93d6-f0ff-4ea5-bed9-688ab924aa85 55298-013 HUMAN OTC DRUG Titralac Plus Calcium Carbonate, Dimethicone TABLET ORAL 20040101 OTC MONOGRAPH FINAL part331 iNova Pharmaceuticals Pty, Ltd CALCIUM CARBONATE; DIMETHICONE 420; 21 mg/1; mg/1 55298-038_dfb735c1-d80e-4fed-b1f7-dce766aa3848 55298-038 HUMAN OTC DRUG Titralac Calcium Carbonate TABLET ORAL 20040101 OTC MONOGRAPH FINAL part331 iNova Pharmaceuticals Pty, Ltd CALCIUM CARBONATE 420 mg/1 55301-000_9a44a271-73ba-497e-bbea-f7c57e84de6b 55301-000 HUMAN OTC DRUG Exchange Select Sunscreen SPF 15 OCTINOXATE OXYBENZONE LOTION TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE OCTINOXATE; OXYBENZONE 7.5; 4.5 g/100g; g/100g 55301-001_297e84d7-c76d-485d-9d34-99d2eff5be6a 55301-001 HUMAN OTC DRUG Exchange Select Sunscreen SPF 45 OCTINOXATE OXYBENZONE LOTION TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 12; 5; 1.6; 3.5 g/100g; g/100g; g/100g; g/100g; g/100g 55301-002_607e1534-a267-4be3-bad7-3edcf4bd31af 55301-002 HUMAN OTC DRUG Exchange Select Sport Sunscreen SPF 15 OCTINOXATE OXYBENZONE LOTION TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE OCTINOXATE; OCTISALATE; OXYBENZONE 6; 5; 2 g/100g; g/100g; g/100g 55301-003_aa1d3f09-19c9-44fb-926c-6b4b98b6ccb3 55301-003 HUMAN OTC DRUG Exchange Select Sport Sunscreen SPF 30 OCTINOXATE OXYBENZONE LOTION TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g 55301-004_9e609228-1ecd-47b1-95db-830f2072207d 55301-004 HUMAN OTC DRUG Kids Flouride Rinse Sodium Fluoride RINSE ORAL 20110209 OTC MONOGRAPH FINAL part355 Army + Air Force Exchange Service SODIUM FLUORIDE .05 kg/100L 55301-005_d55a4fd0-4745-4ad6-8ada-f22cd96ef4eb 55301-005 HUMAN OTC DRUG Exchange Select Dark Tanning Sunscreen SPF 4 OCTOCRYLENE LOTION TOPICAL 20131025 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE OCTOCRYLENE; OXYBENZONE 1; .5 g/100g; g/100g 55301-006_216e5585-94dc-46b6-bb0c-08f085fce521 55301-006 HUMAN OTC DRUG Exchange Select Baby Sunscreen SPF 50 AVOBENZONE LOTION TOPICAL 20131007 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 55301-007_764157c9-eb74-401e-b8aa-57504389c2c9 55301-007 HUMAN OTC DRUG Exchange Select Kids Sunscreen SPF 50 AVOBENZONE SPRAY TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g 55301-008_7fe0f16f-903e-4384-b1a1-a0c358272e88 55301-008 HUMAN OTC DRUG Exchange Select Sunscreen SPF 50 AVOBENZONE LOTION TOPICAL 20131018 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 55301-009_2287e865-d8a3-4426-b994-540b32081649 55301-009 HUMAN OTC DRUG Exchange Select Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g 55301-010_3957a9ea-a3a7-497e-a5fa-be43038dd598 55301-010 HUMAN OTC DRUG Exchange Select Sport Sunscreen SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g 55301-011_f9a0eadd-1b4c-4942-a9ea-7333aa642f5d 55301-011 HUMAN OTC DRUG Exchange Select Sport Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g 55301-012_da810782-f3ca-4126-9c70-1c24af7ad34c 55301-012 HUMAN OTC DRUG Exchange Select Sheer Dry Touch Sunscreen SPF 70 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20131021 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2.8; 6 g/100g; g/100g; g/100g; g/100g; g/100g 55301-013_72e1bded-4608-475f-b720-1e56e3ad8f2a 55301-013 HUMAN OTC DRUG Exchange Select Sunscreen SPF 70 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20131024 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g 55301-014_c5979230-bf93-4599-a680-e273f15fb3a3 55301-014 HUMAN OTC DRUG EXSEL SPORT SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100g; g/100g; g/100g; g/100g 55301-015_085571e1-72da-48fe-aea6-09ee24d95fe4 55301-015 HUMAN OTC DRUG EXSEL SPORT SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g 55301-016_b3bc117d-9634-4e5a-8295-a84248905732 55301-016 HUMAN OTC DRUG EXSEL ALOE LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part348 ARMY AND AIR FORCE EXCHANGE SERVICE LIDOCAINE HYDROCHLORIDE .5 g/100g 55301-017_2ad125c1-76c2-40f5-a999-ed51e497d74e 55301-017 HUMAN OTC DRUG EXCEL SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g 55301-018_41200ffd-b261-42fd-bb6b-da663166bb25 55301-018 HUMAN OTC DRUG EXCEL SPORT SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g 55301-019_0f8c1a8d-cde5-4728-9d0a-7a14c36554b4 55301-019 HUMAN OTC DRUG EXSEL SPORT SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g 55301-020_c0dc405e-26fb-49a6-80a5-8338eb5598bf 55301-020 HUMAN OTC DRUG EXCEL SPORT SPF 50 AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 6; 4 g/100g; g/100g; g/100g 55301-044_4501e75d-7de2-4260-a145-a63cfeebfad3 55301-044 HUMAN OTC DRUG Exchange Select Burn Relief Pain Relieving LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part348 ARMY AND AIR FORCE EXCHANGE SERVICE LIDOCAINE HYDROCHLORIDE .5 g/100g 55301-063_772bc78e-406c-4b32-ac62-b113d9350495 55301-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 20021029 OTC MONOGRAPH FINAL part347 For Your Military Exchange FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL 55301-069_e4b1011e-be5d-49b3-a667-53e769979f25 55301-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 20090106 OTC MONOGRAPH FINAL part347 Your Military Exchange PETROLATUM 1 g/g 55301-091_01df246a-8b92-48b9-b5d0-f249ab674ac0 55301-091 HUMAN OTC DRUG Oil of Beauty Octinoxate, zinc oxide LOTION TOPICAL 20071022 OTC MONOGRAPH FINAL part352 Your Military Exchange OCTINOXATE; ZINC OXIDE 60; 30 mg/mL; mg/mL 55301-094_3669b8d4-81fe-4792-8fb5-836ee54282ef 55301-094 HUMAN OTC DRUG Hair Regrowth Treatment for Men Extra Strength minoxidil SOLUTION TOPICAL 20070517 ANDA ANDA075518 Army and Air Force Exchange Service MINOXIDIL 50 mg/mL 55301-117_6b043f0a-5cd6-44f6-b688-715ae07e2dc2 55301-117 HUMAN OTC DRUG Exchange Select Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120611 ANDA ANDA202319 Army & Air Force Exchange Service LANSOPRAZOLE 15 mg/1 55301-153_e5187930-156e-4b30-9ad7-6716610582b4 55301-153 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19990126 OTC MONOGRAPH FINAL part358H Your Military Exchanges PYRITHIONE ZINC 1 kg/100L 55301-159_f325b9eb-7246-43f5-9d92-b9b545d845c7 55301-159 HUMAN OTC DRUG Extra Strength Headache Formula Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 55301-163_e3080611-8845-4aab-a410-bc75a5a650d1 55301-163 HUMAN OTC DRUG Anticavity Sodium Fluoride MOUTHWASH ORAL 20060129 OTC MONOGRAPH FINAL part355 Your Military Exchanges SODIUM FLUORIDE 999.5 mL/100L 55301-175_94d62afb-75bf-49e7-94e9-c0e0fe1bdd2f 55301-175 HUMAN OTC DRUG Acetaminophen Acetaminophen CAPSULE ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN 500 mg/1 55301-179_e7410cb8-5be3-41e1-892e-e25ed8145478 55301-179 HUMAN OTC DRUG TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sulfate OINTMENT TOPICAL 20030101 OTC MONOGRAPH FINAL part333B Exchange Select BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 55301-180_1562a183-c96d-440f-9e05-a34469d4b4a6 55301-180 HUMAN OTC DRUG Healing for Babies Petrolatum OINTMENT TOPICAL 20120320 OTC MONOGRAPH FINAL part347 Your Military Exchange PETROLATUM 41 kg/100kg 55301-189_2ebd3dc1-6ea6-4cbb-802a-900646d5bd22 55301-189 HUMAN OTC DRUG Sleep-Aid Diphenhydramine HCl TABLET ORAL 19921225 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55301-190_fbcc2263-c7ed-4816-9fa8-e5c12ccd3101 55301-190 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part336 ARMY AND AIR FORCE EXCHANGE SERVICE DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55301-205_9f58853b-94d9-4dde-a90c-400a6a9fe4e0 55301-205 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20080204 OTC MONOGRAPH FINAL part358H Your Military Exchange COAL TAR 2.5 mL/100L 55301-210_c28e412b-16f0-456a-ad18-a57a256f40b6 55301-210 HUMAN OTC DRUG Antiseptic Eucalyptol MOUTHWASH ORAL 20101018 OTC MONOGRAPH NOT FINAL part356 Exchange Select EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 mL/100L; mL/100L; mL/100L; mL/100L 55301-213_d260eb73-b947-4911-9627-f7387c64b23d 55301-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20041224 OTC MONOGRAPH FINAL part355 Army + Air Force Exchange Service SODIUM FLUORIDE .05 kg/100L 55301-226_7498e30d-c7d2-4769-ac93-3a0d56d6fb8d 55301-226 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19921121 OTC MONOGRAPH FINAL part340 ARMY AND AIR FORCE EXCHANGE SERVICE CAFFEINE 200 mg/1 55301-227_6fc5ac83-10f7-4dfe-b916-56983d6e5606 55301-227 HUMAN OTC DRUG Regular Strength Aspirin Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ASPIRIN 325 mg/1 55301-233_7c279e8d-23f3-43c4-8816-daca60c9d446 55301-233 HUMAN OTC DRUG Mucus Relief Cold, Flu and Sore Throat Maximum Strength Mucinex Fast Max Cold, Flu and Sore Throat Maximum Strength LIQUID ORAL 20131121 OTC MONOGRAPH FINAL part341 Exchange Select ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL 55301-234_0c8c8482-a988-4e1e-a0c0-697c98bb1cd7 55301-234 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Mucinex Fast Max Severe Congestion and Cough Maximum Strength LIQUID ORAL 20131121 OTC MONOGRAPH FINAL part341 Exchange Select DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL 55301-242_7942541f-dfe5-47d4-801a-567738f0f90e 55301-242 HUMAN OTC DRUG EZ Nite Sleep Berry ZzzQuil LIQUID ORAL 20131121 OTC MONOGRAPH FINAL part341 Exchange Select DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 55301-243_26142ecf-c214-4ec0-864b-07e311311f13 55301-243 HUMAN OTC DRUG Antibacterial Hand Triclosan LIQUID TOPICAL 20090106 OTC MONOGRAPH FINAL part333A Your Military Exchange TRICLOSAN .15 kg/100L 55301-253_f1c83752-b63b-4f9c-8e1a-bf4a3d1c4d53 55301-253 HUMAN OTC DRUG Extra Strength Pain Reliever PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55301-271_fdddcb3e-9edb-4478-8c35-7ba36ec47191 55301-271 HUMAN OTC DRUG exchange select acid reducer Ranitidine TABLET ORAL 20120912 ANDA ANDA076760 Army & Air Force Exchange Service RANITIDINE HYDROCHLORIDE 75 mg/1 55301-281_3e8043b4-2b44-46e1-9459-0cdec1112cee 55301-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20020606 OTC MONOGRAPH FINAL part358H Your Military PYRITHIONE ZINC 1 kg/100L 55301-291_30987f6a-9bcb-4693-8938-064b8a57e2f4 55301-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 ARMY AND AIR FORCE EXCHANGE SERVICE IBUPROFEN 200 mg/1 55301-299_1c9b035a-eb49-40b3-90ad-4361febe898d 55301-299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 20100628 OTC MONOGRAPH NOT FINAL part356 Your Military Exchanges CETYLPYRIDINIUM CHLORIDE .7 mg/mL 55301-311_f48d256b-502b-48c1-b058-ceee9a4e5db9 55301-311 HUMAN OTC DRUG Dandruff Dandruff LOTION/SHAMPOO TOPICAL 20040709 OTC MONOGRAPH FINAL part358H Your Military Exchanges PYRITHIONE ZINC 1 kg/100kg 55301-319_d4c1c8f2-ac5c-4fa6-aea7-93bea693c095 55301-319 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate TABLET, CHEWABLE ORAL 19980716 OTC MONOGRAPH FINAL part335 ARMY AND AIR FORCE EXCHANGE SERVICE BISMUTH SUBSALICYLATE 262 mg/1 55301-326_e49aa3cb-aa20-405d-8db3-19bb6a4d190e 55301-326 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19991025 OTC MONOGRAPH NOT FINAL part356 Your Military Exchanges EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 55301-329_90f57fe0-c81f-4a66-992b-e3f2b1890c2e 55301-329 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE, COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55301-343_e76990ba-4f7a-4d7c-b71d-b2766e578d11 55301-343 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20050314 OTC MONOGRAPH NOT FINAL part348 Army and Air Force Exchange Service HYDROCORTISONE 1 g/100g 55301-350_7d2a8a16-bba5-425c-922b-5225a6ee6e69 55301-350 HUMAN OTC DRUG Clotrimazole Antifungal clotrimazole CREAM TOPICAL 20060203 OTC MONOGRAPH FINAL part333C Army and Air Force Exchange Service CLOTRIMAZOLE 10 mg/g 55301-351_2fb20915-7fd0-4b57-abcc-ed5b70ecc3da 55301-351 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 19950921 OTC MONOGRAPH NOT FINAL part334 ARMY AND AIR FORCE EXCHANGE SERVICE DOCUSATE SODIUM 100 mg/1 55301-357_6b272dd2-34f2-4d32-92b5-3967be18f579 55301-357 HUMAN OTC DRUG exchange select antacid regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20130108 OTC MONOGRAPH FINAL part331 Army & Air Force Exchange Service ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 55301-368_4e96403a-8218-41e3-9d6c-b5335965ba57 55301-368 HUMAN OTC DRUG exchange select naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20080826 ANDA ANDA074661 Army & Air Force Exchange Service NAPROXEN SODIUM 220 mg/1 55301-369_71379fd9-51fd-4e3d-a98f-38f202afd74d 55301-369 HUMAN OTC DRUG Maximum Strength Menstrual Pain Relief Acetaminophen, Pamabrom and Pyrilamine maleate CAPSULE, COATED ORAL 20000620 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 55301-370_11a84c02-b537-422d-a034-aedd967fafd7 55301-370 HUMAN OTC DRUG Advanced Ethyl Alcohol GEL TOPICAL 20120927 OTC MONOGRAPH NOT FINAL part333A Your Military Exchanges ALCOHOL 70 kg/100L 55301-373_c78cf35c-2cf5-4105-be53-90b7bce382d4 55301-373 HUMAN OTC DRUG Pain Relief Medicine PM Acetaminophen and Diphenhydramine Citrate TABLET ORAL 20040607 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 55301-375_183747d0-1d3e-4721-9f24-a5baa0456f85 55301-375 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl CAPSULE ORAL 20050503 ANDA ANDA076497 ARMY AND AIR FORCE EXCHANGE SERVICE LOPERAMIDE HYDROCHLORIDE 2 mg/1 55301-379_b72056f7-e4b3-4fa8-a75b-9894018d49a9 55301-379 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20131130 OTC MONOGRAPH NOT FINAL part348 Exchange Select MENTHOL 1.5 mg/g 55301-388_40d2090d-c332-4dcb-9f43-5ee467e7b3d1 55301-388 HUMAN OTC DRUG Exchange Select Nasal Oxymetazoline HCl SPRAY NASAL 20140106 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Service OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 55301-392_338f2ea2-74c8-4ebc-a229-85aa1ff610d5 55301-392 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20020330 ANDA ANDA075139 ARMY AND AIR FORCE EXCHANGE SERVICE IBUPROFEN 200 mg/1 55301-393_19850603-0f5d-4fcc-ad34-f4de62e0f666 55301-393 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, COATED ORAL 20020408 ANDA ANDA075139 ARMY AND AIR FORCE EXCHANGE SERVICE IBUPROFEN 200 mg/1 55301-403_d8147b3e-52f2-4d98-a312-b144cd355a48 55301-403 HUMAN OTC DRUG Motion Sickness II Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 ARMY AND AIR FORCE EXCHANGE SERVICE MECLIZINE HYDROCHLORIDE 25 mg/1 55301-406_9c34c498-6110-4c1e-9311-823753ca0702 55301-406 HUMAN OTC DRUG Exchange Select Cold Sore Treatment Benzalkonium Chloride CREAM TOPICAL 20110804 OTC MONOGRAPH NOT FINAL part333A Army + Air Force Exchange Service BENZALKONIUM CHLORIDE 1.3 mg/g 55301-411_4c05c9ee-aaea-4f8b-bf09-8482ec71b142 55301-411 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate and Dextromethorphan HBr TABLET ORAL 20030503 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 55301-414_c45395ae-c1c5-4012-bbf4-cfc621f64df1 55301-414 HUMAN OTC DRUG Adult Low Strength Aspirin Aspirin TABLET, COATED ORAL 20040114 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ASPIRIN 81 mg/1 55301-442_6867a1c1-40e4-4bdd-a984-1347a8e34e55 55301-442 HUMAN OTC DRUG Adult Tussin Cough Gels Dextromethorphan HBr CAPSULE, GELATIN COATED ORAL 20060424 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 55301-447_b2d6de56-d06f-476f-b789-a8e344e8fb10 55301-447 HUMAN OTC DRUG Childrens Pain Reliever Acetaminophen TABLET, ORALLY DISINTEGRATING ORAL 20050203 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN 80 mg/1 55301-453_2c47566e-8c80-46a3-aad1-4fa4efb71c38 55301-453 HUMAN OTC DRUG Non-Drowsy Suphedrine PE Congestion Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 55301-455_1a53803a-c35e-4fd5-b922-049ee9961015 55301-455 HUMAN OTC DRUG Allergy Mutli-Symptom Acetaminophen, Chlorpheniramine Maleate and Phenylephrine HCl TABLET ORAL 20060530 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 55301-462_4c72009d-d53f-400c-be40-3222b95a8856 55301-462 HUMAN OTC DRUG Suphedrine PE Sinus and Allergy Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20050609 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 55301-464_016df476-fa7c-4d6e-8544-6a0b05e28ae9 55301-464 HUMAN OTC DRUG Allergy and Sinus Headache Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET ORAL 20050615 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 55301-466_b879dd32-80b4-4a9f-bbae-e43fb1eb566f 55301-466 HUMAN OTC DRUG Sinus Congestion and Pain Acetaminophen and Phenylephrine HCl TABLET ORAL 20050726 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN 325 mg/1 55301-468_fa8e049c-1dda-4030-bee6-71a422023790 55301-468 HUMAN OTC DRUG Exchange Select Calcium Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20110609 OTC MONOGRAPH FINAL part331 Army & Air Force Exchange Service CALCIUM CARBONATE 750 mg/1 55301-478_06ed726f-71e7-43c8-bf83-c28c139eda87 55301-478 HUMAN OTC DRUG Exchange Select Calcium Antacid calcium carbonate TABLET, CHEWABLE ORAL 20110616 OTC MONOGRAPH FINAL part331 Army & Air Force Exchange Service CALCIUM CARBONATE 500 mg/1 55301-489_2cdc1a78-8140-46b6-b22e-e124f2ec46e9 55301-489 HUMAN OTC DRUG Exchange Select Calcium Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20110526 OTC MONOGRAPH FINAL part331 Army & Air Force Exchange Service CALCIUM CARBONATE 750 mg/1 55301-500_3d0b5598-884d-495b-87c2-e8c3e9e2a887 55301-500 HUMAN OTC DRUG Pre-moistened Medicated WipesHemorrhoidal wipeHemorrhoidal wipeHemorrhoidal wipeHemorrhoidal wipe Hemorrhoidal wipes with witch hazel witch hazel CLOTH TOPICAL 20130701 OTC MONOGRAPH FINAL part346 ARMY AND AIR FORCE EXCHANGE SERVICE WITCH HAZEL 129 g/258g 55301-519_9e4bd7f8-7530-4b09-90c1-d23deff4b39f 55301-519 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN 500 mg/1 55301-525_a497af5d-c981-4d79-ad35-eb6f819d924b 55301-525 HUMAN OTC DRUG Aphedrid Cold and Allergy Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20020722 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 55301-527_13d1c359-0488-4eab-bad5-11d081c3b265 55301-527 HUMAN OTC DRUG Sinus Congestion and Pain Severe Aceetaminophen, Guaifenesin and Phenylephrine HCl TABLET ORAL 20050806 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 55301-529_5954cd7e-ef28-4cd3-85fa-8ea7b1ffc0a0 55301-529 HUMAN OTC DRUG Multi-Symptom Cold Relief Acetaminophen, Chlorpehniramine HCl, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE 55301-533_e8f2d092-9d9f-46e6-a09a-e57ab312a211 55301-533 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan HBr and Guiafenesin TABLET, FILM COATED ORAL 20051231 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 55301-534_c28a0f2e-a277-4290-a3c6-fec117aad6d9 55301-534 HUMAN OTC DRUG Daytime Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20070919 OTC MONOGRAPH NOT FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 55301-535_0c3f4f75-d97e-4873-93e3-682f21da63cc 55301-535 HUMAN OTC DRUG Cold and Flu Relief Multi-Symptom, Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20070910 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 55301-551_e9ba7021-8cb8-48aa-9540-e40e8b72b386 55301-551 HUMAN OTC DRUG Medicated Menthol, zinc oxide POWDER TOPICAL 20030910 OTC MONOGRAPH NOT FINAL part348 Your Military Exchange MENTHOL; ZINC OXIDE 1.5; 10 mg/g; mg/g 55301-556_a7860fc3-3505-45d4-88ff-8c39140ce689 55301-556 HUMAN OTC DRUG Extra Strength Pain Reliever PM Acetaminophen and Diphenhydramine HCl CAPSULE ORAL 20071217 OTC MONOGRAPH NOT FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55301-559_04776a1e-b2c7-435d-9716-c190c8568f1a 55301-559 HUMAN OTC DRUG Allergy Multi-Symptom Acetaminophen, Phenylephrine HCl, Chlorpheniramine maleate CAPSULE, GELATIN COATED ORAL 20080317 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 55301-571_44f7c76d-196a-49f7-a0bf-632b9ac643c7 55301-571 HUMAN OTC DRUG exchange select allergy relief fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110926 ANDA ANDA076447 Army & Air Force Exchange Service FEXOFENADINE HYDROCHLORIDE 180 mg/1 55301-590_c3d0efbf-efcf-425d-a033-652c983c3529 55301-590 HUMAN OTC DRUG Exchange Select Allergy Relief Cetirizine Hydrochloride TABLET ORAL 20140206 ANDA ANDA078336 Army & Air Force Exchange Service CETIRIZINE HYDROCHLORIDE 10 mg/1 55301-600_012b7554-d392-46d1-ab63-b54d8f4c583d 55301-600 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ASPIRIN 81 mg/1 55301-602_7b6b268e-a310-409d-98f4-de9b3c7ac547 55301-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20021218 OTC MONOGRAPH FINAL part334 Your Military Exchange MAGNESIUM SULFATE 1 g/g 55301-612_c5e9bc88-ae9c-4369-99b5-502d10c31e8f 55301-612 HUMAN OTC DRUG exchange select allergy relief Loratadine TABLET ORAL 20080826 ANDA ANDA076301 Army & Air Force Exchange Service LORATADINE 10 mg/1 55301-615_e83fb3ed-675a-4f20-8c1f-75ab48c9377d 55301-615 HUMAN OTC DRUG Maximum Strength Multi-Symptom Cold and Sinus Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET ORAL 20130407 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 55301-616_6f9e89eb-5725-4709-854d-1273ddef7a90 55301-616 HUMAN OTC DRUG Maximum Strength Mucus Relief Cold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET ORAL 20130407 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 55301-619_9418ef5e-4a66-420b-9367-28c72893efe5 55301-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20110406 OTC MONOGRAPH FINAL part347 Your Military Exchanges DIMETHICONE 1.3 kg/100mL 55301-623_f263c374-4d3a-47b2-b363-e498d3b736d8 55301-623 HUMAN OTC DRUG Womens Gentle Laxative Bisacodyl TABLET, COATED ORAL 20050212 OTC MONOGRAPH NOT FINAL part334 ARMY AND AIR FORCE EXCHANGE SERVICE BISACODYL 5 mg/1 55301-664_3e415dba-1db0-4704-b716-6168a5ea3af9 55301-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20020709 OTC MONOGRAPH NOT FINAL part356 Your Military Exchanges EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 55301-667_94f98e46-31c2-4c7c-a537-30284dfd339e 55301-667 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20120123 OTC MONOGRAPH FINAL part334 Your Military Exchange MAGNESIUM CITRATE 1.745 g/29.6mL 55301-730_b6f28a47-28c6-4292-bfc2-62cbe55a1fd8 55301-730 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20020712 ANDA ANDA074164 Exchange Select MICONAZOLE NITRATE 2 g/100g 55301-821_a9d8d8cc-6c71-40d8-903b-784e1573bbd7 55301-821 HUMAN OTC DRUG Adult Chewable Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ASPIRIN 81 mg/1 55301-822_a37d3723-0871-4446-bc7b-c9f3ed17d0ab 55301-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 20021029 OTC MONOGRAPH FINAL part347 Your Military Exchanges WITCH HAZEL 86 kg/100L 55301-823_4aa3f7e6-b256-4f80-b39a-3ed7fc9def90 55301-823 HUMAN OTC DRUG Triple Antibiotic Plus Maximum Strength bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hcl OINTMENT TOPICAL 20050301 OTC MONOGRAPH FINAL part333B Exchange Select BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 55301-852_5ece41c3-2daf-4d78-90a2-9ff0bd1fbf50 55301-852 HUMAN OTC DRUG Exchange Select Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20140106 ANDA ANDA091429 Army & Air Force Exchange Service RANITIDINE HYDROCHLORIDE 150 mg/1 55301-871_90058aaa-092d-447c-b748-ff56f1b8189c 55301-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20021010 OTC MONOGRAPH NOT FINAL part333A Army + Air Force Exchange Service HYDROGEN PEROXIDE .3 kg/100L 55301-915_4a6bc207-6d41-4067-90f5-bd978168be7c 55301-915 HUMAN OTC DRUG exchange select omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20081028 NDA NDA022032 Army & Air Force Exchange Service OMEPRAZOLE 20 mg/1 55301-939_497df1ad-c032-474f-aae4-1235f7e6f6cd 55301-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Army & Air Force Exchange Service CETIRIZINE HYDROCHLORIDE 10 mg/1 55301-941_db2a2da4-1dff-48d5-84e8-83fefdfcafa1 55301-941 HUMAN OTC DRUG Hand wash Benzalkonium chloride LIQUID TOPICAL 20140728 OTC MONOGRAPH NOT FINAL part333A Your Military Exchange BENZALKONIUM CHLORIDE 1.3 mg/mL 55301-992_92e8d27b-8558-48a6-bfc7-4c74c02fb099 55301-992 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20010913 OTC MONOGRAPH FINAL part336 ARMY AND AIR FORCE EXCHANGE SERVICE DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55305-111_ae5c7e38-d112-4ff3-8757-aac3dc864848 55305-111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20131230 OTC MONOGRAPH NOT FINAL part333E Aero Healthcare ALCOHOL .665 g/mL 55305-113_b8073b11-106e-48b0-b2a8-37f01e18ba9d 55305-113 HUMAN OTC DRUG Aeroaid Antiseptic First Aid benzocaine and benzethonium chloride AEROSOL, SPRAY TOPICAL 20140820 OTC MONOGRAPH NOT FINAL part348 Aero Healthcare, LLC. BENZETHONIUM CHLORIDE; BENZOCAINE 76.5; 3825 mg/85g; mg/85g 55305-114_5c18bb44-43ee-4f35-8f1a-6fde76f3dd79 55305-114 HUMAN OTC DRUG Aerowound Blood Clotting First Aid benzethonium chloride and lidocaine AEROSOL, SPRAY TOPICAL 20140820 OTC MONOGRAPH NOT FINAL part348 Aero Healthcare, LLC. BENZETHONIUM CHLORIDE; LIDOCAINE 76.5; 756.5 mg/85g; mg/85g 55305-116_d0e2594d-82eb-47d1-992d-c22824c639cf 55305-116 HUMAN OTC DRUG Aeroburn Burn First Aid benzethonium chloride, benzocaine, and menthol AEROSOL, SPRAY TOPICAL 20140820 OTC MONOGRAPH NOT FINAL part348 Aero Healthcare, LLC. BENZETHONIUM CHLORIDE; BENZOCAINE; MENTHOL 170; 8500; 281 mg/85g; mg/85g; mg/85g 55310-001_92cccc28-94a8-4b0d-9d46-94b1b7374e7d 55310-001 HUMAN OTC DRUG Assured Isopropyl Alcohol PATCH TOPICAL 20130104 OTC MONOGRAPH NOT FINAL part333A SHANGHAI YINJING MEDICAL SUPPLIES CO., LTD. ISOPROPYL ALCOHOL .7 mL/mL 55312-000_5930aae2-0c91-4643-aa0b-001a7e8b3411 55312-000 HUMAN OTC DRUG Western Family Broad Spectrum Sunscreen SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 WESTERN FAMILY FOODS, INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g 55312-001_5eba8937-d359-45ca-95d0-14e1a9b9a95e 55312-001 HUMAN OTC DRUG Stool Softener plus Stimulant Laxative Docusate sodium and Sennosides TABLET ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 55312-002_f252412a-cb37-49d5-bbf7-fbb5c1ad5aa3 55312-002 HUMAN OTC DRUG WESTERN FAMILY Alcohol Swabs ISOPROPYL ALCOHOL LIQUID TOPICAL 20120114 OTC MONOGRAPH FINAL part333A Western Family Foods, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 55312-003_e9de92b1-628f-4d40-b8f9-e4957827d8c7 55312-003 HUMAN OTC DRUG Western Family Complete Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20081124 OTC MONOGRAPH FINAL part355 Western Family Foods, Inc SODIUM FLUORIDE 2.43 mg/g 55312-004_8a60cb2f-5646-4a11-aa2b-1d1ce6dbca63 55312-004 HUMAN OTC DRUG Anti Cavity Rinse Sodium Fluoride RINSE ORAL 20090512 OTC MONOGRAPH FINAL part355 Western Family Foods, Inc SODIUM FLUORIDE .05 kg/100L 55312-005_5a94acc7-f3a3-42e2-b88e-f1751d391dbf 55312-005 HUMAN OTC DRUG Western Family Sport Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20140702 OTC MONOGRAPH NOT FINAL part352 WESTERN FAMILY FOODS, INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g 55312-006_1f1f76f1-ff31-416b-9b27-86ea2ab8a56b 55312-006 HUMAN OTC DRUG Western Family Broad Spectrum SunscreenSPF 50 SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20140702 OTC MONOGRAPH NOT FINAL part352 WESTERN FAMILY FOODS, INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 55312-007_d45b3eca-ca25-4cff-a003-5444c782662d 55312-007 HUMAN OTC DRUG Western Family Baby Broad Spectrum Sunscreen SPF 50 AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20140702 OTC MONOGRAPH NOT FINAL part352 WESTERN FAMILY FOODS, INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 55312-008_79febacc-0a03-4a06-bd26-f27af3cb4ce6 55312-008 HUMAN OTC DRUG Infants Acetaminophen Concentrated Acetaminophen SUSPENSION/ DROPS ORAL 19911205 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 80 mg/.8mL 55312-010_6589bd7e-94e6-4332-983a-78b42f75335a 55312-010 HUMAN OTC DRUG lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20141119 OTC MONOGRAPH FINAL part358G Western Family Foods Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 55312-012_b0650448-ef6f-4cc1-9771-8d3eaead739b 55312-012 HUMAN OTC DRUG Western Family Aloe Vera Moisturizing LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20140702 OTC MONOGRAPH NOT FINAL part348 WESTERN FAMILY FOODS, INC. LIDOCAINE HYDROCHLORIDE .5 g/100g 55312-013_9a843f34-91ab-4890-b92d-73e0a8916f57 55312-013 HUMAN OTC DRUG Western Family HydroCortisone Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Western Family Foods Inc HYDROCORTISONE 1 g/100g 55312-014_c99c081b-de38-410a-91ef-22c43576c2fe 55312-014 HUMAN OTC DRUG cold relief Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20090720 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 55312-015_e7236d55-23f7-4f0e-b0a7-1e6cb3d636d8 55312-015 HUMAN OTC DRUG WESTERN FAMILY OIL FREE FACES SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20140702 OTC MONOGRAPH NOT FINAL part352 WESTERN FAMILY FOODS, INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g 55312-016_abaec9e2-8f3c-4da8-84a9-55a34957362d 55312-016 HUMAN OTC DRUG Senna- S Docusate sodium and Sennosides TABLET ORAL 20130301 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 55312-017_192ccbf8-52eb-4781-9465-d3b7c430d803 55312-017 HUMAN OTC DRUG Western FAMILY SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part352 WESTERN FAMILY FOODS, INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100g; g/100g; g/100g; g/100g 55312-019_20b27f52-3a1b-4ec6-bb95-19988139a685 55312-019 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120724 ANDA ANDA202727 Western Family Foods, Inc. LANSOPRAZOLE 15 mg/1 55312-020_2fa9bdb6-7cc0-4093-8631-cc6e084e79cd 55312-020 HUMAN OTC DRUG Western Family Antifungal Tolnaftate CREAM TOPICAL 20060217 OTC MONOGRAPH FINAL part333C Western Family Foods Inc TOLNAFTATE 10 mg/g 55312-021_42665001-1bac-4d63-876d-20d9857f9ebf 55312-021 HUMAN OTC DRUG Congestion Relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20140917 ANDA ANDA203200 Western Family Foods Inc IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 55312-027_25a6cc4a-0464-4830-beb1-3345f999910c 55312-027 HUMAN OTC DRUG allergy relief eye Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20110525 ANDA ANDA077958 Western Family Foods Inc KETOTIFEN FUMARATE .25 mg/mL 55312-029_320ef10b-3e37-48e5-8b52-b9e258fd6427 55312-029 HUMAN OTC DRUG Epsom Salt MAGNESIUM SULFATE GRANULE ORAL 19980605 OTC MONOGRAPH NOT FINAL part334 Western Family MAGNESIUM SULFATE 100 kg/100kg 55312-034_843b7897-d103-43eb-bcb1-2a3841c1ac8a 55312-034 HUMAN OTC DRUG WESTERN FAMILY HEMORRHOIDAL MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL OINTMENT TOPICAL 20120731 OTC MONOGRAPH FINAL part346 WESTERN FAMILY FOOD, INC. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/g; mg/g; mg/g 55312-035_7823fa33-13ad-492e-842e-af3f5ca88cd9 55312-035 HUMAN OTC DRUG Western Family Hemorrhoidal Mineral Oil OINTMENT TOPICAL 20130630 OTC MONOGRAPH FINAL part346 Western Family Food, Inc. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 749; 2.5 mg/100g; mg/100g; mg/100g 55312-041_d38a1a48-8729-4eb7-894b-b93e04dea37c 55312-041 HUMAN OTC DRUG Night Relief Free acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090915 OTC MONOGRAPH FINAL part341 Western Family Foods inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 55312-046_2ffab2fc-683f-42d7-b346-4ff73ac02b07 55312-046 HUMAN OTC DRUG Acetaminophen Rapid Release Extra Strength Acetaminophen TABLET, COATED ORAL 20090819 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 500 mg/1 55312-047_b8be814d-24ff-4b46-9b50-187aa1b4aaa0 55312-047 HUMAN OTC DRUG acid reducer Ranitidine TABLET ORAL 20080314 ANDA ANDA078653 Western Family Foods Inc RANITIDINE HYDROCHLORIDE 150 mg/1 55312-050_484ef627-96fd-4feb-9f55-31e72d305b80 55312-050 HUMAN OTC DRUG ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090311 ANDA ANDA079113 Western Family Foods Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 55312-051_25a2f2e1-429a-4753-9ee2-8be917481cc0 55312-051 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 20140228 OTC MONOGRAPH FINAL part340 Western Family Foods, Inc. CAFFEINE 200 mg/1 55312-052_8cb47378-ca23-483f-bd0f-80fdf1391e5f 55312-052 HUMAN OTC DRUG zzz sleep Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140128 OTC MONOGRAPH FINAL part338 Western Family Foods Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55312-053_b2f1c850-5157-4b73-b008-9a4dae2c4bb5 55312-053 HUMAN OTC DRUG Western Family Itch Relief DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20130430 OTC MONOGRAPH NOT FINAL part348 Western Family Food, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 55312-054_b8c8c43d-7c7f-430f-afe6-6d8427dd2221 55312-054 HUMAN OTC DRUG Western Family Pain Relieving Camphor CREAM TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Western Family Food, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE .04; .1; .3 g/g; g/g; g/g 55312-055_24c50480-0f51-47a4-bd13-822c52fafcc1 55312-055 HUMAN OTC DRUG Western Family Benzalkonium chloride CLOTH TOPICAL 20130530 OTC MONOGRAPH NOT FINAL part333A Western Family Foods Inc BENZALKONIUM CHLORIDE .115 g/1 55312-056_5e06a79b-33a4-4b35-a9de-db4ad474c842 55312-056 HUMAN OTC DRUG night relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140213 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 55312-057_7a1bfa33-955b-417f-bbad-a0f596898ad3 55312-057 HUMAN OTC DRUG ibuprofen infants ibuprofen SUSPENSION ORAL 20000816 ANDA ANDA075217 Western Family Foods Inc IBUPROFEN 50 mg/1.25mL 55312-063_487d7e98-cead-45d5-b338-9df3d93e2e96 55312-063 HUMAN OTC DRUG Western Family HydroCortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Western Family Foods Inc HYDROCORTISONE 1 g/100g 55312-065_8db3a7d8-8b5f-414e-937f-95a8ac6f502b 55312-065 HUMAN OTC DRUG Nasal D Oxymetazoline Hydrochloride SPRAY NASAL 20141117 OTC MONOGRAPH FINAL part341 Western Family Foods Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 55312-069_f978d7ec-1fe2-423d-9adf-d7b48e336c84 55312-069 HUMAN OTC DRUG Pure petroleum White Petrolatum JELLY TOPICAL 19900215 OTC MONOGRAPH FINAL part347 Western Family Foods, Inc PETROLATUM 1 g/g 55312-072_3fcb7279-b0b0-40dd-afb8-769a5514e837 55312-072 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 19951114 OTC MONOGRAPH NOT FINAL part348 Western Family Foods, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 55312-075_bfdd52d4-a967-45b4-9366-290311438c51 55312-075 HUMAN OTC DRUG Western Family Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Western Family Foods Inc BACITRACIN ZINC 500 [iU]/g 55312-076_e8acab5d-80cb-4e9e-a523-5115399e39f6 55312-076 HUMAN OTC DRUG Western Family Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Western Family Foods Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g 55312-077_c83b0fd9-e5af-4c0c-a3b5-06cf191d81a0 55312-077 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130301 OTC MONOGRAPH NOT FINAL part343 Western Family Foods, Inc. ASPIRIN 81 mg/1 55312-078_6e4e483a-5379-489a-a3ee-75006fc3f16c 55312-078 HUMAN OTC DRUG Isopropyl alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A Western Family Foods, Inc. ISOPROPYL ALCOHOL 91 mL/100mL 55312-092_56dbc128-2638-4e66-b01d-10394e177073 55312-092 HUMAN OTC DRUG Western Family Childrens Allergy Relief Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Western Family Foods Inc LORATADINE 5 mg/5mL 55312-094_3c661609-d26d-4db1-8189-654d37d0b684 55312-094 HUMAN OTC DRUG nasal decongestant pe non drowsy maximum strength Phenylephrine Hydrochloride TABLET ORAL 20070509 OTC MONOGRAPH FINAL part341 Western Family Foods Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 55312-096_a8d262e1-7596-46db-bae5-1664a5f5166a 55312-096 HUMAN OTC DRUG Flu and Severe Cold and Cough Daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20120117 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 55312-100_5e2d4c4e-59a5-4e44-b371-6f87e37da495 55312-100 HUMAN OTC DRUG Day Relief Sinus PE Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20120710 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 55312-101_d54dd319-3ad7-48ce-99d9-03972b2b4fd3 55312-101 HUMAN OTC DRUG Night Relief sinus Acetaminophen, Doxylamine succinate and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20120712 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 55312-103_d9f98d57-37bc-4816-b9e4-46c75c109e0e 55312-103 HUMAN OTC DRUG Aspirin enteric safety coated Aspirin TABLET ORAL 20120104 OTC MONOGRAPH NOT FINAL part343 Western Family Foods, Inc. ASPIRIN 81 mg/1 55312-104_ecdf369d-0b20-4ac9-ad42-e0dbcd6d2fee 55312-104 HUMAN OTC DRUG Aspirin Safety Coated Aspirin TABLET, COATED ORAL 20140501 OTC MONOGRAPH NOT FINAL part343 Western Family Foods, Inc. ASPIRIN 81 mg/1 55312-105_491f2707-8692-413b-9e68-91a6c97d7d45 55312-105 HUMAN OTC DRUG childrens pain relief Acetaminophen SUSPENSION ORAL 19951102 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 160 mg/5mL 55312-106_7eff942d-f18e-498c-abcf-0bcb46834644 55312-106 HUMAN OTC DRUG Western Family Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Western Family Foods Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 55312-107_1a9a45b1-6b16-4569-bc8c-f02a8489bd66 55312-107 HUMAN OTC DRUG Expectorant Guaifenesin TABLET ORAL 20100701 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. GUAIFENESIN 400 mg/1 55312-109_102145c7-2e61-4504-8dc9-e35b8a857d88 55312-109 HUMAN OTC DRUG Expectorant Tab DM Dextromethorphan Hydrobromide and Guaifenesin TABLET ORAL 20100705 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 55312-110_a014198a-b911-4421-b68d-35a3c7284728 55312-110 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. DOCUSATE SODIUM 100 mg/1 55312-111_2decb9d1-1ebc-438c-8a72-c5363607ab7e 55312-111 HUMAN OTC DRUG Western Family Saline Laxative ENEMA RECTAL 20131216 OTC MONOGRAPH NOT FINAL part334 WESTERN FAMILY HOLDING COMPANY SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 55312-117_5f4469a7-295b-4c81-995a-52862bde7269 55312-117 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 Western Family Foods Inc LANSOPRAZOLE 15 mg/1 55312-118_dbc0ea13-ee84-4753-94a5-441809c20491 55312-118 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110201 ANDA ANDA072199 Western Family Foods, Inc. IBUPROFEN 200 mg/1 55312-120_22ee7424-21fb-4a02-98b1-db1d230aeae0 55312-120 HUMAN OTC DRUG WOMENS LAXATIVE Bisacodyl TABLET, COATED ORAL 20100705 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. BISACODYL 5 mg/1 55312-130_1a0d7e09-5e87-4ae9-be3d-af32068f84b3 55312-130 HUMAN OTC DRUG pain relief Acetaminophen SUSPENSION ORAL 19910315 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 160 mg/5mL 55312-139_132e1bc6-1704-4917-9214-6421c9128a99 55312-139 HUMAN OTC DRUG Cold and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20071219 OTC MONOGRAPH FINAL part341 Western Family Foods Inc CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 55312-140_773a6796-4629-4a76-a33e-8a6dfc79acc0 55312-140 HUMAN OTC DRUG all day relief Naproxen sodium TABLET, FILM COATED ORAL 20071219 ANDA ANDA074661 Western Family Foods Inc NAPROXEN SODIUM 220 mg/1 55312-141_ff8139f9-e223-474d-a66f-c25831c5b0ae 55312-141 HUMAN OTC DRUG acid reducer original strength Famotidine TABLET ORAL 20091023 ANDA ANDA075400 Western Family Foods Inc FAMOTIDINE 10 mg/1 55312-145_0346343e-5d56-4c76-b095-44aec26ddeb4 55312-145 HUMAN OTC DRUG mucus relief cold and sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130917 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 55312-153_723d6804-ff72-400e-b0ee-661092893a31 55312-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Western Family Foods, Inc PYRITHIONE ZINC 1 kg/100L 55312-158_63096f4e-6f42-4006-9252-5b2330b6912f 55312-158 HUMAN OTC DRUG Western Family Sensitive Whitening Fluoride Potassium Nitrate and Sodium Fluoride PASTE, DENTIFRICE DENTAL 20070502 OTC MONOGRAPH NOT FINAL part356 Western Family Food, Inc. POTASSIUM NITRATE; SODIUM FLUORIDE 5; 2.43 mg/g; mg/g 55312-160_4d02b0a5-5f04-44f1-9668-46cd339e167b 55312-160 HUMAN OTC DRUG Senna- S docusate sodium and sennosides TABLET ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 55312-161_fe8e208e-bc26-4d12-8687-5aff304390ab 55312-161 HUMAN OTC DRUG infants acetaminophen Acetaminophen LIQUID ORAL 20110825 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 160 mg/5mL 55312-162_4baccc50-7a20-4e0a-85b7-528b2973ff6a 55312-162 HUMAN OTC DRUG Western Family Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20081124 OTC MONOGRAPH FINAL part355 Western Family Foods, Inc SODIUM FLUORIDE 2.43 mg/g 55312-163_0b18bfbf-a029-4f60-8e4e-817f01da2b61 55312-163 HUMAN OTC DRUG Western Family Tartar Control Sodium Fluoride PASTE, DENTIFRICE DENTAL 20081124 OTC MONOGRAPH FINAL part355 Western Family Foods, Inc SODIUM FLUORIDE 2.43 mg/g 55312-164_62798515-110d-472f-a027-11cc75387654 55312-164 HUMAN OTC DRUG Western Family Cavity Control Sodium Fluoride PASTE, DENTIFRICE DENTAL 20081124 OTC MONOGRAPH FINAL part355 Western Family Foods, Inc SODIUM FLUORIDE 2.43 mg/g 55312-166_62c7ffcb-0ee8-4ef4-aeaf-0a8605e53aba 55312-166 HUMAN OTC DRUG childrens ibuprofen Ibuprofen SUSPENSION ORAL 20021007 ANDA ANDA074937 Western Family Foods Inc IBUPROFEN 100 mg/5mL 55312-167_b32609ab-e49e-4e8e-8323-63288b9ed366 55312-167 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110201 ANDA ANDA072199 Western Family Foods, Inc. IBUPROFEN 200 mg/1 55312-173_fd7e5d68-1b37-47a0-8c79-696305337114 55312-173 HUMAN OTC DRUG lice Piperonyl Butoxide, Pyrethrum Extract KIT 20071029 OTC MONOGRAPH FINAL part358G Western Family Foods Inc 55312-175_b530de93-ed0e-498a-aa0e-65eed13e33fa 55312-175 HUMAN OTC DRUG pain relief Acetaminophen SUSPENSION ORAL 19990829 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 160 mg/5mL 55312-179_8b76a0f3-68d8-41b4-9d66-bc8bde889605 55312-179 HUMAN OTC DRUG antacid extra strength Calcium carbonate TABLET, CHEWABLE ORAL 20011031 OTC MONOGRAPH FINAL part331 Western Family Foods Inc CALCIUM CARBONATE 750 mg/1 55312-180_c6920875-91dc-45ae-8934-a06014804ee0 55312-180 HUMAN OTC DRUG Senna Natural vegetable laxative SENNOSIDES TABLET ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. SENNOSIDES 8.6 mg/1 55312-181_57fc357d-bde5-42e6-b063-266a3d22cd37 55312-181 HUMAN OTC DRUG Senna Natural vegetable laxative SENNOSIDES TABLET ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. SENNOSIDES 8.6 mg/1 55312-182_7f6d7336-dcd2-43d1-a252-8d778d2f320b 55312-182 HUMAN OTC DRUG Western Family Whitening Plus Minty Fresh Mouthwash Anticavity Sodium Fluoride PASTE, DENTIFRICE DENTAL 20081124 OTC MONOGRAPH FINAL part355 Western Family Foods, Inc SODIUM FLUORIDE 2.43 mg/g 55312-183_9183fd75-a09d-40a5-9034-a43866b7954b 55312-183 HUMAN OTC DRUG Complete Menstrual Relief Acetaminophen, Caffeine, Pyrilamine maleate TABLET ORAL 20120416 OTC MONOGRAPH NOT FINAL part343 Western Family Foods, Inc. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 55312-184_385ad5a4-e083-45a2-bea2-30895c011d9d 55312-184 HUMAN OTC DRUG Headache relief Extra Strength Acetaminophen, Aspirin and Caffeine TABLET ORAL 20120619 OTC MONOGRAPH NOT FINAL part343 Western Family Foods, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 55312-186_bb207d91-a5e2-4fe8-a979-fb6a0e0377e0 55312-186 HUMAN OTC DRUG Zzz Sleep Diphenhydramine HCl SOLUTION ORAL 20130829 OTC MONOGRAPH FINAL part338 Western Family Foods Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 55312-187_0e98a818-c8b8-4a13-a43b-ee05eecbd95f 55312-187 HUMAN OTC DRUG acetaminophen extra strength Acetaminophen TABLET, COATED ORAL 19941213 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 500 mg/1 55312-190_4c5bb484-1b2c-4bc9-8ce7-6dba63bdee53 55312-190 HUMAN OTC DRUG Gentle and Effective Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20130308 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. BISACODYL 5 mg/1 55312-196_19d0eb08-eed8-4d42-a80d-5453f829f79a 55312-196 HUMAN OTC DRUG Childrens Cough Plus Sore Throat Acetaminophen, Dextromethorphan HBr SUSPENSION ORAL 20081201 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 5 mg/5mL; mg/5mL 55312-197_bbb997ec-ae9d-4362-a978-cca5bcead33d 55312-197 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100313 ANDA ANDA078682 Western Family Foods, Inc. IBUPROFEN 200 mg/1 55312-198_3c08ca4a-6c45-4fbc-997e-020ebe6bcd18 55312-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20140930 ANDA ANDA078682 Western Family Foods, Inc. IBUPROFEN 200 mg/1 55312-199_c16c118b-b57f-4911-985a-50c12c28a2b9 55312-199 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20110711 ANDA ANDA079114 Western Family Foods Inc 55312-200_6e950757-d8b8-416d-a57d-f6e64e19a326 55312-200 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET ORAL 20100712 OTC MONOGRAPH FINAL part336 Western Family Foods, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55312-205_68ac47db-a3c4-4c14-8351-e5a1c2bc8400 55312-205 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20111201 OTC MONOGRAPH FINAL part358H Western Family Foods COAL TAR 2.5 mL/100L 55312-210_99760c9b-8644-4bdd-b5e4-6f2ddb32b90e 55312-210 HUMAN OTC DRUG Tartar Control Eucalyptol MOUTHWASH ORAL 20100923 OTC MONOGRAPH NOT FINAL part356 Western Family EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 mL/100L; mL/100L; mL/100L; mL/100L 55312-211_2f61cfd8-0a34-4873-98d3-995c8140e92c 55312-211 HUMAN OTC DRUG Allergy Relief Cetirizine HCl CAPSULE ORAL 20131230 NDA NDA022429 Western Family Foods, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 55312-213_0888b51e-a5cc-43ff-8d52-cb04fe282fa3 55312-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20031020 OTC MONOGRAPH FINAL part355 Western Family Foods, Inc SODIUM FLUORIDE .05 kg/100L 55312-214_9103b0f9-97ba-4baf-b57d-bcdeac85d856 55312-214 HUMAN OTC DRUG miconazole 7 Miconazole nitrate CREAM VAGINAL 19991008 ANDA ANDA074760 Western Family Foods Inc MICONAZOLE NITRATE 2 g/100g 55312-215_f8a3eaaa-c97e-48ad-bbda-6acaa8559a88 55312-215 HUMAN OTC DRUG day relief pe Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20110408 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 55312-216_b91b617f-7ecd-4e76-88c9-6310c564d3b3 55312-216 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20111215 ANDA ANDA079174 Western Family Foods, Inc. IBUPROFEN 200 mg/1 55312-217_f9fc4d2e-46a7-4366-889a-67ab60ecc26a 55312-217 HUMAN OTC DRUG acetaminophen 8 hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051130 ANDA ANDA075077 Western Family Foods Inc ACETAMINOPHEN 650 mg/1 55312-218_7ddacf90-6468-4342-837c-fe4330f5a7ea 55312-218 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20120705 ANDA ANDA079174 Western Family Foods, Inc. IBUPROFEN 200 mg/1 55312-219_1a920216-a516-4d5d-8632-aa22c8f84e86 55312-219 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20110901 ANDA ANDA079174 Western Family Foods, Inc. IBUPROFEN 200 mg/1 55312-224_5564d5f1-d5a7-4bd6-ad94-bf501dd78975 55312-224 HUMAN OTC DRUG a d Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030225 ANDA ANDA075232 Western Family Foods Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 55312-227_3eda8c35-df76-4a9f-b291-6037ba1cf421 55312-227 HUMAN OTC DRUG acetaminophen easy tabs Acetaminophen TABLET, COATED ORAL 20060209 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 500 mg/1 55312-230_74abcd7f-6851-4d68-bfbb-be0c60d743e3 55312-230 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20100701 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 55312-232_08cf32d5-4f22-40ce-8fe2-866f969b604e 55312-232 HUMAN OTC DRUG Mucus Relief DM Max Maximum Strength Mucinex DM Max Maximum Strength LIQUID ORAL 20131030 OTC MONOGRAPH FINAL part341 Western Family Foods Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL 55312-233_67c19877-62a6-498f-a3cf-61af57dc5fbf 55312-233 HUMAN OTC DRUG Mucus Relief Cold, Flu and Sore Throat Maximum Strength Mucinex Cold, Flu and Sore Throat Maximum Strength LIQUID ORAL 20131106 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL 55312-234_c2a5ea8e-bf79-44c2-bf31-a8de0c62528f 55312-234 HUMAN OTC DRUG cold relief daytime Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20080222 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 55312-235_34998d5b-57ef-4e8a-b028-25717f374c68 55312-235 HUMAN OTC DRUG Mucus Relief Cold and Sinus Maximum Strength Mucinex Cold and Sinus Maximum Strength LIQUID ORAL 20131029 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL 55312-236_cf581af8-068e-4bc4-96f6-5ccb97f8a04d 55312-236 HUMAN OTC DRUG Nighttime Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 55312-238_ea256a30-784b-42dc-bc49-e00a7a0a0395 55312-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130815 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. DOCUSATE SODIUM 100 mg/1 55312-242_f00e53c3-e1aa-4dc8-9bcd-fb07418799d3 55312-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH FINAL part347 Western Family Foods, Inc. DIMETHICONE 125 mg/1 55312-247_ae84a768-b224-4889-8af5-6a62e1c62071 55312-247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140131 OTC MONOGRAPH NOT FINAL part343 Western Family Foods, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 55312-248_ec9fa0af-b0b9-440f-a619-c6b098e1bb16 55312-248 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20131130 ANDA ANDA079174 Western Family Foods, Inc. IBUPROFEN 200 mg/1 55312-250_9ac890c6-3e78-4c47-8194-7b23e0a9a579 55312-250 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 20100701 OTC MONOGRAPH FINAL part340 Western Family Foods, Inc. CAFFEINE 200 mg/1 55312-251_a6929584-6a51-4531-a19b-5e71b217ddf3 55312-251 HUMAN OTC DRUG pain relief odor free Trolamine Salicylate CREAM TOPICAL 19930204 OTC MONOGRAPH NOT FINAL part348 Western Family Foods Inc TROLAMINE SALICYLATE 10 g/100g 55312-252_3fc63701-c6aa-4bdd-855c-f1c1d92956cc 55312-252 HUMAN OTC DRUG Sleep Nighttime Sleep Aid DIPHENHYDRAMINE HCL TABLET ORAL 20140228 OTC MONOGRAPH FINAL part338 Western Family Foods, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55312-259_45ba545f-e73c-48c3-8cde-9af0e747b5cf 55312-259 HUMAN OTC DRUG Aspirin adult low strength Aspirin TABLET, CHEWABLE ORAL 20010918 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ASPIRIN 81 mg/1 55312-268_8ef1c8f6-3722-473c-b259-63edcb3909d4 55312-268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part356 Western Family Foods, Inc. HYDROGEN PEROXIDE 2.65 mL/100mL 55312-271_ad5a572a-8052-47cd-a7fb-4b68535d89c3 55312-271 HUMAN OTC DRUG Acid Relief Ranitidine TABLET ORAL 20090528 ANDA ANDA076760 Western Family Foods Inc RANITIDINE HYDROCHLORIDE 75 mg/1 55312-272_4fd80557-173d-4428-ad60-e23ba5fd61a7 55312-272 HUMAN OTC DRUG sinus relief non drowsy Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20070118 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 55312-275_c244a0e6-c638-4ef2-9a55-200cbb10a8ab 55312-275 HUMAN OTC DRUG Rubbing Alcohol 70 percent Isopropyl Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A Western Family Foods, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 55312-276_a86699a4-edc3-4fb6-8a33-8173f591216f 55312-276 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70 Percent Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A Western Family Foods, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 55312-277_5989f0b9-d1b1-4db7-8ad9-576017fd9c74 55312-277 HUMAN OTC DRUG Aspirin Adult Low Strength Aspirin TABLET, FILM COATED ORAL 20040519 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ASPIRIN 81 mg/1 55312-279_714528a3-30d7-449b-8360-1587be91bb3d 55312-279 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141002 OTC MONOGRAPH FINAL part346 Western Family Foods Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 55312-281_6c6ae9be-f76b-4f05-8370-b6372cab4bf1 55312-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20020614 OTC MONOGRAPH FINAL part358H Western Family PYRITHIONE ZINC 1 kg/100L 55312-296_ed2d7725-44af-4cf3-a0f2-01a3249e1287 55312-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 19980710 OTC MONOGRAPH FINAL part358H Western Family Foods Inc PYRITHIONE ZINC 1 kg/100L 55312-300_561eee7a-edde-44eb-b7a4-43c595159343 55312-300 HUMAN OTC DRUG adult tussin cough Dextromethorphan Hydrobromide LIQUID ORAL 19920911 OTC MONOGRAPH FINAL part341 Western Family Foods Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL 55312-302_fa3becd3-1498-4510-a1fb-dcdde7906615 55312-302 HUMAN OTC DRUG stomach relief original strength Bismuth subsalicylate LIQUID ORAL 19890315 OTC MONOGRAPH FINAL part335 Western Family Foods Inc BISMUTH SUBSALICYLATE 262 mg/15mL 55312-304_7040b3af-3395-41c6-8f13-229b072b49f8 55312-304 HUMAN OTC DRUG nasal d original oxymetazoline hydrochloride SPRAY NASAL 20141113 OTC MONOGRAPH FINAL part341 Western Family Foods Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 55312-305_790aadd8-4f31-48b4-9d86-4a4799d9eb93 55312-305 HUMAN OTC DRUG Western Family Athletes Foot Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Western Family Foods Inc CLOTRIMAZOLE 10 mg/g 55312-306_9b9ead9b-b2cb-4a4e-9921-c75c56c42720 55312-306 HUMAN OTC DRUG Laxative Clear Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091024 ANDA ANDA090685 Western Family Foods Inc POLYETHYLENE GLYCOL 3350 17 g/17g 55312-308_252b5ad7-2cea-4301-bf80-97251d8051c0 55312-308 HUMAN OTC DRUG cold relief Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 19920911 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 55312-309_98f5e759-7f70-45d4-ba24-536e04ffe212 55312-309 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20061114 OTC MONOGRAPH FINAL part358H Western Family Foods, Inc PYRITHIONE ZINC 1 kg/100L 55312-310_f49d077c-f81f-47b6-84c0-4acdff9df665 55312-310 HUMAN OTC DRUG tussin adult chest congestion Guaifenesin SYRUP ORAL 20000410 OTC MONOGRAPH FINAL part341 Western Family Foods Inc GUAIFENESIN 200 mg/10mL 55312-311_1f4e397a-8108-48d4-bf70-bcbb4c9a2999 55312-311 HUMAN OTC DRUG Everyday Clean Pyrithione zinc SHAMPOO TOPICAL 20070207 OTC MONOGRAPH FINAL part358H Western Family Foods, Inc PYRITHIONE ZINC 1 kg/100L 55312-318_be7b5982-e688-4ffc-904a-e57afb0e3499 55312-318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol MOUTHWASH ORAL 19960614 OTC MONOGRAPH NOT FINAL part356 Western Family Foods, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 55312-321_b4cbb599-5fe9-4856-a65a-94c47f2cbb84 55312-321 HUMAN OTC DRUG acid reducer plus antacid famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080827 ANDA ANDA077355 Western Family Foods Inc CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 55312-328_1c21edf2-5b4a-4c1a-9435-d144d39e2800 55312-328 HUMAN OTC DRUG throat relief Phenol SPRAY ORAL 19990407 OTC MONOGRAPH NOT FINAL part356 Western Family Foods Inc PHENOL 10.628 mg/100mL 55312-332_29eb06a5-c42c-426c-8b95-23d27c92df77 55312-332 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide LIQUID ORAL 19921104 OTC MONOGRAPH NOT FINAL part334 Western Family Foods Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 55312-335_4dd5d093-b14f-4815-b342-3289430ff068 55312-335 HUMAN OTC DRUG night relief free Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110914 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 55312-337_381db7d5-95fa-4ade-9529-f48507e2c30a 55312-337 HUMAN OTC DRUG stomach relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 19910615 OTC MONOGRAPH FINAL part335 Western Family Foods Inc BISMUTH SUBSALICYLATE 525 mg/15mL 55312-340_013bd74a-3420-4cd4-8546-83d11cae7739 55312-340 HUMAN OTC DRUG antacid aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 19951018 OTC MONOGRAPH FINAL part331 Western Family Foods Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 55312-345_2170e0d5-c69d-43db-8935-bf9a87eb199b 55312-345 HUMAN OTC DRUG allergy and cough Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140328 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 55312-355_6beafaf2-2c04-45b8-a3ae-a6f7091d8e23 55312-355 HUMAN OTC DRUG added strength pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19971125 OTC MONOGRAPH FINAL part338 Western Family Foods Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55312-357_82b2df75-55fa-444a-9b04-de99bd8bcf29 55312-357 HUMAN OTC DRUG Antacid Regular Strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19900715 OTC MONOGRAPH FINAL part332 Western Family Foods Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 55312-358_67441210-085e-43e8-b0db-8b106825674a 55312-358 HUMAN OTC DRUG sinus and allergy maximum strength Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20070330 OTC MONOGRAPH FINAL part341 Western Family Foods Inc CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 55312-359_f56cc22b-2cc5-4b2f-9206-8e9b999084d2 55312-359 HUMAN OTC DRUG tussin adult Dextromethorphan HBr, Guaifenesin LIQUID ORAL 19910809 OTC MONOGRAPH FINAL part341 Western Family Foods Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 55312-368_450362ec-28a7-476c-9625-731ae15f3540 55312-368 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET, FILM COATED ORAL 19970114 ANDA ANDA074661 Western Family Foods Inc NAPROXEN SODIUM 220 mg/1 55312-369_cbbe0913-db52-4879-a7da-9c112a9d2faa 55312-369 HUMAN OTC DRUG HydroCortisone Intensive Healing Formula Hydrocortisone CREAM TOPICAL 20090311 OTC MONOGRAPH NOT FINAL part348 Western Family Foods Inc HYDROCORTISONE 1 g/100g 55312-371_43ad9b4e-819d-455d-a5ba-faaedf984d61 55312-371 HUMAN OTC DRUG Cold Relief Daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20090115 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 55312-374_7d629012-d545-4c30-9985-6e538739ff52 55312-374 HUMAN OTC DRUG migraine formula Acetaminophen, Aspirin, Caffeine TABLET, COATED ORAL 20021004 ANDA ANDA075794 Western Family Foods Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 55312-376_fe0794ba-5f7a-4fb0-a08b-2d90cb2ed540 55312-376 HUMAN OTC DRUG Sore Throat Relief Phenol LIQUID ORAL 20140630 OTC MONOGRAPH NOT FINAL part356 Western Family Foods, Inc. PHENOL 1.4 g/100mL 55312-377_746201c0-ec99-44a2-8e73-d4dac80830ee 55312-377 HUMAN OTC DRUG Sore Throat Relief Phenol LIQUID ORAL 20140630 OTC MONOGRAPH NOT FINAL part356 Western Family Foods, Inc. PHENOL 1.4 g/100mL 55312-379_4f13732c-b777-4742-b571-333c9279d0ab 55312-379 HUMAN OTC DRUG Childrens Complete Allergy Diphenhydramine Hydrochloride LIQUID ORAL 19930908 OTC MONOGRAPH FINAL part341 Western Family Foods Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 55312-381_cea8bb5a-5558-48d3-b591-b2fe7b7170da 55312-381 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130917 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 55312-384_5daa0727-02ba-4f8e-86a9-2286716648bc 55312-384 HUMAN OTC DRUG 12 hour cough relief dextromethorphan polistirex SUSPENSION ORAL 20120914 ANDA ANDA091135 Western Family Foods Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 55312-390_e9b3e130-a371-43ca-836c-9adcd2d48aed 55312-390 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20141031 OTC MONOGRAPH FINAL part347 Western Family Foods, Inc. WITCH HAZEL 842 mg/mL 55312-393_288c29c0-c124-4a98-a241-6fb71864e85c 55312-393 HUMAN OTC DRUG Cold Relief Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070730 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 55312-396_eea6d600-ad69-495d-b387-49b55105727d 55312-396 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide LIQUID ORAL 19921104 OTC MONOGRAPH NOT FINAL part334 Western Family Foods Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 55312-397_27e830f5-91d8-469f-ba5c-fb3ba3cf5837 55312-397 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen LIQUID ORAL 20120711 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 160 mg/5mL 55312-402_4fd10645-96ec-4059-ae1b-b9af45f7a69e 55312-402 HUMAN OTC DRUG cold relief non drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20070420 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 55312-404_cf384d29-7507-497f-904b-69ab254723b2 55312-404 HUMAN OTC DRUG enema Saline ENEMA RECTAL 20091231 OTC MONOGRAPH NOT FINAL part334 Western Family Foods Inc SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 55312-407_82399c57-1874-4b76-9969-bbd27c18a6d4 55312-407 HUMAN OTC DRUG Western Family Cold Sore Treatment Camphor CREAM TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part348 Western Family Foods Inc BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g 55312-419_4b42a2b5-ca17-450f-bdb4-f6792d9ad523 55312-419 HUMAN OTC DRUG expectorant cough childrens Dextromethorphan hbr, Guaifenesin LIQUID ORAL 20071026 OTC MONOGRAPH FINAL part341 Western Family Foods Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 55312-430_ae2bf533-4277-487b-b3d7-1413d986c968 55312-430 HUMAN OTC DRUG headache relief added strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20010820 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 55312-431_6353fa3f-1949-4593-81df-4b57b26f3c83 55312-431 HUMAN OTC DRUG nighttime Diphenhydramine Hydrochloride TABLET ORAL 20010128 OTC MONOGRAPH FINAL part338 Western Family Foods Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55312-437_e6ee64ba-49e6-4463-a9d6-010ffd33f261 55312-437 HUMAN OTC DRUG acetaminophen pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19921118 OTC MONOGRAPH FINAL part338 Western Family Foods Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55312-440_09fe0264-2ad2-4ff2-8e1e-17fae705044f 55312-440 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin TABLET, DELAYED RELEASE ORAL 20120104 OTC MONOGRAPH FINAL part343 Western Family Foods, Inc. ASPIRIN 81 mg/1 55312-441_b24be07b-240b-4a05-9f10-1d6450232765 55312-441 HUMAN OTC DRUG Nighttime Sleepaid Doxylamine succinate TABLET ORAL 19971111 ANDA ANDA040167 Western Family Foods Inc DOXYLAMINE SUCCINATE 25 mg/1 55312-444_62716807-7255-424f-b2bb-5f271d3c18c8 55312-444 HUMAN OTC DRUG Antacid Ultra Strength Calcium Carbonate TABLET, CHEWABLE ORAL 20140421 OTC MONOGRAPH FINAL part331 Western Family Foods Inc CALCIUM CARBONATE 1000 mg/1 55312-458_a70c53b0-c5c0-4fbc-89e9-c9120c47d5bf 55312-458 HUMAN OTC DRUG allergy relief Cetirizine Hydrochloride TABLET ORAL 20080125 ANDA ANDA078336 Western Family Foods Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 55312-459_7664d906-7619-4d66-88ea-6ff5b4be59e8 55312-459 HUMAN OTC DRUG night relief free Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110829 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 55312-461_734289dc-b048-4386-880f-45dc09147ce0 55312-461 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20040924 ANDA ANDA076359 Western Family Foods Inc IBUPROFEN 100 mg/1 55312-462_600bdf78-3452-48f0-857f-6242e5f508ce 55312-462 HUMAN OTC DRUG allergy diphenhydramine HCl CAPSULE ORAL 20030409 OTC MONOGRAPH FINAL part341 Western Family Foods Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55312-463_d37f85c8-4aef-4e1a-9369-648625632c63 55312-463 HUMAN OTC DRUG chlortab Chlorpheniramine Maleate TABLET ORAL 20070522 OTC MONOGRAPH FINAL part341 Western Family Foods Inc CHLORPHENIRAMINE MALEATE 4 mg/1 55312-466_c4334f39-08f0-4dfd-8a1a-596f2ddc2aff 55312-466 HUMAN OTC DRUG Laxative bisacodyl SUPPOSITORY RECTAL 20130221 OTC MONOGRAPH NOT FINAL part334 Western Family Foods Inc BISACODYL 10 mg/1 55312-467_69ffac02-37e7-4699-b6c2-4c5ac00c2f03 55312-467 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 19930330 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ASPIRIN 81 mg/1 55312-468_7b2b9dc2-516d-48ad-9228-ecfe61b8e103 55312-468 HUMAN OTC DRUG antacid Calcium carbonate TABLET, CHEWABLE ORAL 20011031 OTC MONOGRAPH FINAL part331 Western Family Foods Inc CALCIUM CARBONATE 750 mg/1 55312-469_263388c7-5033-49c2-9e57-70f2fddea65a 55312-469 HUMAN OTC DRUG Effervescent Pain Relief Aspirin, Citric Acid Monohydrate, and Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20080128 OTC MONOGRAPH FINAL part343 Western Family Foods, Inc. ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 55312-476_9337bffa-6337-4f79-b9ac-ebb0a0de52a6 55312-476 HUMAN OTC DRUG Allergy Multi Symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20061211 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 55312-477_968a8b7d-b9ea-464a-8ff8-8e259f438bc3 55312-477 HUMAN OTC DRUG fiber Calcium polycarbophil TABLET, FILM COATED ORAL 19980119 OTC MONOGRAPH NOT FINAL part334 Western Family Foods Inc CALCIUM POLYCARBOPHIL 625 mg/1 55312-478_82cd048b-c0f1-4698-aecd-cd3f089dc6f7 55312-478 HUMAN OTC DRUG antacid calcium carbonate TABLET, CHEWABLE ORAL 20011022 OTC MONOGRAPH FINAL part331 Western Family Foods Inc CALCIUM CARBONATE 500 mg/1 55312-484_1e51abcb-a13d-4651-bcf1-7176f551d6a2 55312-484 HUMAN OTC DRUG acetaminophen extra strength Acetaminophen TABLET ORAL 20080314 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 500 mg/1 55312-485_810326a0-c34f-4d51-a177-adadc4a79c10 55312-485 HUMAN OTC DRUG Antacid calcium carbonate TABLET, CHEWABLE ORAL 20011022 OTC MONOGRAPH FINAL part331 Western Family Foods Inc CALCIUM CARBONATE 500 mg/1 55312-489_58b9bbcf-0066-45b7-ac3d-16542e6192ad 55312-489 HUMAN OTC DRUG Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20011126 OTC MONOGRAPH FINAL part331 Western Family Foods Inc CALCIUM CARBONATE 750 mg/1 55312-490_a171b23b-747a-4f7c-9379-d2b87b8bb8ba 55312-490 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET ORAL 19970115 ANDA ANDA074661 Western Family Foods Inc NAPROXEN SODIUM 220 mg/1 55312-496_96d4de5c-f7ba-4f49-8910-52f846e2ef61 55312-496 HUMAN OTC DRUG cold relief Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20070501 OTC MONOGRAPH FINAL part341 Western Family Foods Inc 55312-498_4ff8297e-297e-4fe3-96da-61e7e2da2e2c 55312-498 HUMAN OTC DRUG expectorant 12 Hour Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130325 ANDA ANDA078912 Western Family Foods Inc GUAIFENESIN 600 mg/1 55312-500_6423670a-5ae2-4e82-b39d-bdabc07be7d2 55312-500 HUMAN OTC DRUG Western Family Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Western Family Foods Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 55312-504_c65c1293-c635-438e-8b8b-1c8c86c8b30a 55312-504 HUMAN OTC DRUG Western Family Triple Antibiotic plus Pain Relief Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Western Family Foods Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g 55312-515_30fe2bbe-3acc-4abc-a979-c61543dabd72 55312-515 HUMAN OTC DRUG day relief night relief sinus pe Acetaminophen, Doxylamine succinate , Phenylephrine HCl KIT 20071116 OTC MONOGRAPH FINAL part341 Western Family Foods Inc 55312-516_be7e6ea7-830a-41e5-85d3-bb945b2c8f67 55312-516 HUMAN OTC DRUG Tussin CF Adult Non Drowsy Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20060501 OTC MONOGRAPH FINAL part341 Western Family Foods Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 55312-517_f0326349-cec5-4b2a-901d-04cd2b21afd4 55312-517 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060531 ANDA ANDA077349 Western Family Foods Inc IBUPROFEN 200 mg/1 55312-520_d9869610-4bd3-4992-bc86-196b69eec387 55312-520 HUMAN OTC DRUG Anti-Diarrheal loperamide HCl LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100705 NDA NDA021855 Western Family Foods, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 55312-521_413d4788-a215-43bb-991b-77dc6d69d253 55312-521 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20090407 ANDA ANDA076359 Western Family Foods Inc IBUPROFEN 100 mg/1 55312-530_b5465b5d-bfeb-4f2d-ae6f-01bc2483e9d2 55312-530 HUMAN OTC DRUG Antigas ultra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20100701 OTC MONOGRAPH FINAL part332 Western Family Foods, Inc. DIMETHICONE 180 mg/1 55312-535_75719633-f3ca-4ce0-b7b8-c1cb851bd5bf 55312-535 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin TABLET, DELAYED RELEASE ORAL 20030709 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ASPIRIN 81 mg/1 55312-544_01b17bd3-760d-4da1-9958-bf5347f2933a 55312-544 HUMAN OTC DRUG acetaminophen arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060320 ANDA ANDA075077 Western Family Foods Inc ACETAMINOPHEN 650 mg/1 55312-546_23a272dd-5ee4-4239-8962-a66f76f83361 55312-546 HUMAN OTC DRUG acid reducer plus antacid Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080827 ANDA ANDA077355 Western Family Foods Inc CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 55312-550_ca4b2541-6b71-4fb4-9a6f-dda326e8c6dd 55312-550 HUMAN OTC DRUG AntiGas Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100313 OTC MONOGRAPH FINAL part332 Western Family Foods, Inc. DIMETHICONE 125 mg/1 55312-557_ecc0e2b3-3d48-4634-827b-24f5c0b7cfa1 55312-557 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20121102 OTC MONOGRAPH FINAL part346 Western Family Foods Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g 55312-571_55fa76f2-0106-401f-bc2b-9be7f47fae13 55312-571 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Western Family Foods Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 55312-578_3f5a87b2-8fea-43f4-bd45-b952d660fbaa 55312-578 HUMAN OTC DRUG tussin dm Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19991203 OTC MONOGRAPH FINAL part341 Western Family Foods Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 55312-588_8ab77066-6733-49f5-9560-dd49f3bcbb50 55312-588 HUMAN OTC DRUG Antacid Maximum Strength Aluminum Hydroxide, Magnesium Hydroxide, Simethicone LIQUID ORAL 20060424 OTC MONOGRAPH FINAL part332 Western Family Foods Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 55312-590_456dafcf-a839-4ccf-af8d-f3c868296add 55312-590 HUMAN OTC DRUG infants acetaminophen acetaminophen LIQUID ORAL 20120427 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 160 mg/5mL 55312-595_e7de1032-d7ae-4ed5-a853-4abfaf618caf 55312-595 HUMAN OTC DRUG antacid maximum strength ultra Calcium Carbonate TABLET, CHEWABLE ORAL 20011212 OTC MONOGRAPH FINAL part331 Western Family Foods Inc CALCIUM CARBONATE 1000 mg/1 55312-603_d9e3baa5-de62-4e1e-b3f8-687677603a15 55312-603 HUMAN OTC DRUG DayTime Severe Cold and Flu Relief acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20140926 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 55312-604_ed701a4c-ff79-4789-a4c2-b0de32aec203 55312-604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET ORAL 20010905 ANDA ANDA072096 Western Family Foods Inc IBUPROFEN 200 mg/1 55312-612_ebdf8e13-059d-4170-b940-1d92cb7f852e 55312-612 HUMAN OTC DRUG Allergy Relief 24 hour Loratadine TABLET ORAL 20050404 ANDA ANDA076301 Western Family Foods Inc LORATADINE 10 mg/1 55312-615_f3a8b9f1-ec79-4a80-a175-af99539eb7d9 55312-615 HUMAN OTC DRUG Itchy Eye Relief Ketotifen SOLUTION OPHTHALMIC 20110525 ANDA ANDA077958 Western Family Foods Inc KETOTIFEN FUMARATE .25 mg/mL 55312-630_ac3b8372-4ada-41db-b2be-90b43a68619c 55312-630 HUMAN OTC DRUG Motion Sickness Relief Dimenhydrinate TABLET ORAL 20100701 OTC MONOGRAPH FINAL part336 Western Family Foods, Inc. DIMENHYDRINATE 50 mg/1 55312-645_1134379c-2bd9-4d6e-ac4b-8ca56d84dd95 55312-645 HUMAN OTC DRUG loperamide hydrochloride loperamide HCl LIQUID ORAL 20120519 ANDA ANDA091292 Western Family Foods Inc LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 55312-647_df7a7c39-09d7-4669-8495-956959e00d6d 55312-647 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 20010905 ANDA ANDA072096 Western Family Foods Inc IBUPROFEN 200 mg/1 55312-656_c4743c65-cc9c-470f-80b5-460df22b3cbe 55312-656 HUMAN OTC DRUG DayRelief NON DROWSY MULTI SYMPTOM COLD FLU acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20060705 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 55312-660_8650e4d6-d9a0-451c-b9c6-fa1f794ba56d 55312-660 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 20021014 ANDA ANDA074937 Western Family Foods Inc IBUPROFEN 100 mg/5mL 55312-664_f3cf68b1-8c55-44a6-998b-a2340829277e 55312-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19980315 OTC MONOGRAPH NOT FINAL part356 Western Family Foods, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 55312-666_47b52859-208a-4c00-9fbb-13a1d7351ef1 55312-666 HUMAN OTC DRUG cold and cough Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20060223 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 55312-667_09916a32-cae1-4894-8da9-008a0516544c 55312-667 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 19900415 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc MAGNESIUM CITRATE 1.745 g/29.61mL 55312-668_8d9d25a7-0f31-4869-9339-6b760c66f49b 55312-668 HUMAN OTC DRUG Night Relief Cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20021021 OTC MONOGRAPH FINAL part341 Western Family Foods Inc DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 55312-685_f477b9d1-77f5-40f4-85dd-c86b2ff7f57a 55312-685 HUMAN OTC DRUG childrens ibuprofen Ibuprofen LIQUID ORAL 20080818 ANDA ANDA074937 Western Family Foods Inc IBUPROFEN 100 mg/5mL 55312-688_8f5c129e-eaee-4cc4-a583-3ebad6f6c7cb 55312-688 HUMAN OTC DRUG sinus relief Oxymetazoline HCl SPRAY NASAL 20100107 OTC MONOGRAPH FINAL part341 Western Family Foods Inc OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL 55312-698_9469104e-f06c-481c-a4b7-2fd16cd0db01 55312-698 HUMAN OTC DRUG cough and sore throat daytime Acetaminophen, Dextromethorphan HBr LIQUID ORAL 20060321 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 500; 15 mg/15mL; mg/15mL 55312-700_aa4c8a57-70f1-4865-983f-22d66ecd870e 55312-700 HUMAN OTC DRUG cold and cough daytime Acetaminophen, Dextromethorphan HBr LIQUID ORAL 20060321 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 500; 15 mg/15mL; mg/15mL 55312-720_af3da19e-df3a-46ff-8215-f121a8e6362d 55312-720 HUMAN OTC DRUG Complete Allergy Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20131230 OTC MONOGRAPH FINAL part336 Western Family Foods, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55312-733_080fc67a-e4a7-4675-abc1-ef3833683674 55312-733 HUMAN OTC DRUG NightRelief DayRelief acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20120202 OTC MONOGRAPH FINAL part341 Western Family Foods Inc 55312-733_abfd0196-1b26-4c48-8249-e590897e2287 55312-733 HUMAN OTC DRUG Night Relief Day Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130110 OTC MONOGRAPH FINAL part341 Western Family Foods Inc 55312-742_3730557e-db64-471b-9779-8c818153af7f 55312-742 HUMAN OTC DRUG Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20110118 NDA NDA021920 Western Family Foods Inc NAPROXEN SODIUM 220 mg/1 55312-751_91c3fa2a-d824-4396-b4ba-c34c33522e4f 55312-751 HUMAN OTC DRUG acetaminophen pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120121 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55312-758_a3a81c6e-d4da-44fa-9839-357abc3b54c2 55312-758 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride SUSPENSION ORAL 20140521 ANDA ANDA091292 Western Family Foods Inc LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 55312-759_8c23dec1-5ed5-49c6-b424-fe0c66d67adf 55312-759 HUMAN OTC DRUG pain relief Acetaminophen SUSPENSION ORAL 20110225 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 160 mg/5mL 55312-763_3e509af3-82e5-4598-b914-8863b20c693c 55312-763 HUMAN OTC DRUG nitetime severe cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20140926 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 55312-766_0a7a3052-caa4-4d7d-9a83-94ea35c556aa 55312-766 HUMAN OTC DRUG infants acetaminophen Acetaminophen LIQUID ORAL 20120427 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 160 mg/5mL 55312-799_32375a2f-3afe-4a8e-98a2-677ef329c495 55312-799 HUMAN OTC DRUG Adult Tussin DM Max Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140120 OTC MONOGRAPH FINAL part341 Western Family Foods Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 55312-800_19decd28-5dc2-40f6-b605-c2452a03cffa 55312-800 HUMAN OTC DRUG allergy relief Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20140917 ANDA ANDA076447 Western Family Foods Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 55312-807_fbd7a023-5a03-4032-9056-a9131936ce05 55312-807 HUMAN OTC DRUG Cold Remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20090202 UNAPPROVED HOMEOPATHIC Western Family Foods Inc ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 55312-818_9380853a-6475-4fbe-ab78-6029a91a2a71 55312-818 HUMAN OTC DRUG day relief Dextromethorphan HBr, Guaifenesin LIQUID ORAL 19970318 OTC MONOGRAPH FINAL part341 Western Family Foods Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/15mL; mg/15mL 55312-822_5d6e9f16-269b-4d67-a040-41428390e156 55312-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 19961125 OTC MONOGRAPH FINAL part347 Western Family Foods, Inc WITCH HAZEL 86 kg/100L 55312-825_b6c7a2cb-9cbb-4e5f-a853-2086e4839851 55312-825 HUMAN OTC DRUG Miconazole 7 Miconazole nitrate CREAM VAGINAL 20110810 ANDA ANDA074760 Western Family Foods Inc MICONAZOLE NITRATE 2 g/100g 55312-829_a739c0f9-ed85-433e-9ad8-eb40d98d414e 55312-829 HUMAN OTC DRUG acetaminophen pm extra strength Acetaminophen, Diphenhydramine HCl CAPSULE, COATED ORAL 20100826 OTC MONOGRAPH FINAL part338 Western Family Foods Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55312-831_4be7c62e-50fa-4656-b8f9-b5c5e81e281a 55312-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 19940901 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. MINERAL OIL 999 mg/mL 55312-839_660496b6-96ed-4b72-ba16-753e88b99687 55312-839 HUMAN OTC DRUG childrens mucus relief multi symptom cold dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20140618 OTC MONOGRAPH FINAL part341 Western Family Foods Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 55312-843_687951f2-0d75-4895-a277-c3aa362209bf 55312-843 HUMAN OTC DRUG hemorrhoidal cooling Phenylephrine HCl, Witch hazel GEL TOPICAL 20120924 OTC MONOGRAPH FINAL part346 Western Family Foods Inc PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/100g; g/100g 55312-851_98dc095c-e9c4-462a-9040-c66c37ddca73 55312-851 HUMAN OTC DRUG antacid regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20021031 OTC MONOGRAPH FINAL part332 Western Family Foods Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 55312-852_a5734176-2e88-49f1-93df-def8258af7b1 55312-852 HUMAN OTC DRUG Acid Relief Ranitidine TABLET, FILM COATED ORAL 20131127 ANDA ANDA091429 Western Family Foods Inc RANITIDINE HYDROCHLORIDE 150 mg/1 55312-866_2f199ee8-b0d1-48b7-b96b-5ac19dfc1b14 55312-866 HUMAN OTC DRUG lice treatment Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070907 OTC MONOGRAPH FINAL part358G Western Family Foods Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL 55312-871_682af4db-78b0-4960-9019-de690fae7be0 55312-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19900315 OTC MONOGRAPH NOT FINAL part333A Western Family HYDROGEN PEROXIDE .3 kg/100L 55312-882_a1e19337-8bc0-4bee-be53-e32768274aba 55312-882 HUMAN OTC DRUG infants anti gas dye free Simethicone EMULSION ORAL 20090115 OTC MONOGRAPH FINAL part332 Western Family Foods Inc DIMETHICONE 20 mg/.3mL 55312-884_8346ca82-aa0e-412c-bf90-7986f8cf4f9a 55312-884 HUMAN OTC DRUG allergy relief childrens cetirizine Hydrochloride LIQUID ORAL 20101025 ANDA ANDA090254 Western Family Foods Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 55312-886_6b60c1e7-5daa-412d-8590-f04133c3525d 55312-886 HUMAN OTC DRUG sinus relief Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20070605 OTC MONOGRAPH FINAL part341 Western Family Foods Inc 55312-886_ba047c37-50e9-41f7-81e3-9abe34a91d49 55312-886 HUMAN OTC DRUG sinus relief Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20110922 OTC MONOGRAPH FINAL part341 Western Family Foods Inc 55312-890_568ecc44-a44d-4d13-8a5d-231d3d7be661 55312-890 HUMAN OTC DRUG Allerfed Cold and Allergy PE Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20100705 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 55312-896_932a5b2c-2a85-4c58-8b3c-1c4e46bd2662 55312-896 HUMAN OTC DRUG Dry Eye Therapy Polyethylene glycol, Propylene glycol SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20131125 OTC MONOGRAPH FINAL part349 Western Family Foods Inc POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 g/100mL; g/100mL 55312-897_1210566e-8f80-4045-8d25-9807ad1a210e 55312-897 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION ORAL 19990128 ANDA ANDA074937 Western Family Foods Inc IBUPROFEN 100 mg/5mL 55312-903_03d13f30-ac33-4bb6-956b-65b3de3bd40c 55312-903 HUMAN OTC DRUG multi symptom cold plus childrens Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20081210 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 55312-908_ab235adc-b5f1-4841-8387-0943d454d320 55312-908 HUMAN OTC DRUG NightRelief Free Multi symptom cold flu acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20060501 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 55312-915_4bf018ad-4606-40be-90ae-5aee831b641f 55312-915 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080228 NDA NDA022032 Western Family Foods Inc OMEPRAZOLE 20 mg/1 55312-917_cf5115cc-0e4d-46bf-9a66-80de1904e27b 55312-917 HUMAN OTC DRUG acetaminophen Acetaminophen CAPSULE, COATED ORAL 20110401 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 500 mg/1 55312-922_5b83cbb5-812d-4b30-855e-3327dc48f166 55312-922 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130917 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 55312-926_966481cb-7352-4e99-b5a3-67c80947acda 55312-926 HUMAN OTC DRUG Day Relief Night Relief Free Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20070817 OTC MONOGRAPH FINAL part341 Western Family Foods Inc 55312-942_c3f2f567-c498-47ae-877a-9ee164ccc48c 55312-942 HUMAN OTC DRUG cold and flu nighttime Acetaminophen, diphenhydramine HCl, phenylephrine HCl TABLET, FILM COATED ORAL 20140926 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 55312-944_c68be8de-36e7-4b34-b398-6e524d141b0b 55312-944 HUMAN OTC DRUG hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20120924 OTC MONOGRAPH FINAL part346 Western Family Foods Inc GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g 55312-946_e93a87b8-f791-45d7-a53a-504c01bf086a 55312-946 HUMAN OTC DRUG acetaminophen Acetaminophen LIQUID ORAL 20110825 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 160 mg/5mL 55312-947_2fa4be84-d0ce-48d2-9d90-8cb0b13c1fb8 55312-947 HUMAN OTC DRUG Menstrual relief maximum strength ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE TABLET ORAL 20100705 OTC MONOGRAPH NOT FINAL part343 Western Family Foods, Inc. ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 55312-949_acb2091b-e8da-4d91-9cbd-9d06ff8cee44 55312-949 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide LIQUID ORAL 20050711 OTC MONOGRAPH NOT FINAL part334 Western Family Foods Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 55312-950_28b84ae2-63a0-44e8-8c53-e0ad3b6c77b1 55312-950 HUMAN OTC DRUG acid relief Ranitidine TABLET, FILM COATED ORAL 20111003 ANDA ANDA091429 Western Family Foods Inc RANITIDINE HYDROCHLORIDE 150 mg/1 55312-951_a6df3df6-5d0a-4f7b-a737-62a275ee3b07 55312-951 HUMAN OTC DRUG Severe Cold Daytime Cold and Flu Nighttime Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl, diphenhydramine HCl KIT 20141010 OTC MONOGRAPH FINAL part341 Western Family Foods Inc 55312-958_028cfa40-c89f-4609-944d-58d3c678acf3 55312-958 HUMAN OTC DRUG 12 Hour Cough Relief dextromethorphan polistirex SUSPENSION ORAL 20130703 ANDA ANDA091135 Western Family Foods Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 55312-959_ef73b2c6-0e81-4c83-887e-a5b86a936ddc 55312-959 HUMAN OTC DRUG pain Relief childrens Acetaminophen SUSPENSION ORAL 20120711 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 160 mg/5mL 55312-960_2654c6fe-048e-40e3-86fc-3b99bcd00bba 55312-960 HUMAN OTC DRUG a d Loperamide HCl TABLET, FILM COATED ORAL 20030410 ANDA ANDA075232 Western Family Foods Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 55312-964_86964444-59c8-47c4-8642-11237505f5aa 55312-964 HUMAN OTC DRUG flu and severe cold and cough nighttime Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20100923 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 55312-977_d92539ba-103a-4fcc-bda7-dacb8c1b9983 55312-977 HUMAN OTC DRUG night relief multi symptom cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20070509 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 55312-982_b09c1388-92bf-43e7-a051-df710a9b37c7 55312-982 HUMAN OTC DRUG miconazole 3 Miconazole nitrate KIT 20050121 ANDA ANDA076357 Western Family Foods Inc 55312-982_b8366723-176a-4660-a38a-9066f67a82c0 55312-982 HUMAN OTC DRUG Miconazole 3 miconazole nitrate KIT 20070910 ANDA ANDA076357 Western Family Foods Inc 55312-994_6a81537d-3cba-4ed0-b46b-4a8d277298b0 55312-994 HUMAN OTC DRUG dayrelief pe Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20070712 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 55315-003_469b51ca-4778-4366-8e00-6805fcb1469b 55315-003 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine Hydrochloride LIQUID ORAL 20131023 OTC MONOGRAPH FINAL part338 fred's, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 55315-005_99550ace-08dc-4995-a219-7812c87a8dbb 55315-005 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE ORAL 20130315 OTC MONOGRAPH NOT FINAL part334 Freds Inc DOCUSATE SODIUM 100 mg/1 55315-019_899ee4ee-6eca-4003-bbd2-a946582387c9 55315-019 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20121204 ANDA ANDA202727 Freds Inc LANSOPRAZOLE 15 mg/1 55315-035_82c3ae93-e78a-413d-a298-fd33a51e236f 55315-035 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100625 ANDA ANDA090283 Fred's Inc. FAMOTIDINE 10 mg/1 55315-047_f6319ca2-8d1e-4f94-a2fa-1bcd5a86b173 55315-047 HUMAN OTC DRUG Cold Head Congestion Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050715 OTC MONOGRAPH FINAL part341 FRED'S, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 55315-099_2daad0c9-377c-4599-baa8-fadc7efa7b17 55315-099 HUMAN OTC DRUG Day Time Sinus Pain Reliever, Nasal Decongestant Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20120815 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 55315-100_c29ff8c7-bab4-44cb-9b13-32c808271684 55315-100 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20120330 OTC MONOGRAPH FINAL part343 FREDS, INC ACETAMINOPHEN 500 mg/1 55315-101_7edb0e1d-733a-4266-b3b9-a16f68772c74 55315-101 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20120510 OTC MONOGRAPH FINAL part343 FREDS, INC ACETAMINOPHEN 500 mg/1 55315-102_d5a14933-4166-40bc-82a9-0c6dd0997453 55315-102 HUMAN OTC DRUG Night Time Sinus Acetaminophen, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20121205 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 55315-103_e393e616-e4ca-4dd8-86dd-1902425ce1b5 55315-103 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin TABLET, COATED ORAL 20130315 OTC MONOGRAPH NOT FINAL part343 Freds Inc ASPIRIN 81 mg/1 55315-104_8679a049-8bad-4fa2-9797-55a73e908284 55315-104 HUMAN OTC DRUG Aspirin Safety coated Aspirin TABLET, COATED ORAL 20140831 OTC MONOGRAPH NOT FINAL part343 Freds Inc ASPIRIN 81 mg/1 55315-110_9fdb4653-5b43-4cde-b0fc-ea71010bbcd1 55315-110 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100301 OTC MONOGRAPH NOT FINAL part334 Freds Inc DOCUSATE SODIUM 100 mg/1 55315-118_39f6f573-e51d-4669-8273-3ef195025762 55315-118 HUMAN OTC DRUG FREDS ADVANCED EYE DROPS DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL SOLUTION OPHTHALMIC 20121015 OTC MONOGRAPH FINAL part349 FREDS, INC DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL 55315-121_0c2d45bc-b7ab-4e39-9266-c4b3f431f29f 55315-121 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120702 ANDA ANDA202300 Freds Inc IBUPROFEN 200 mg/1 55315-123_7229ffc2-3b67-495e-bf7d-c42f8f6e7e8f 55315-123 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Fred's Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 55315-124_8d7ee5f2-5b40-413e-b286-8d969907d0a6 55315-124 HUMAN OTC DRUG Freds Astringent Rdeness Reliever Eye TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20130630 OTC MONOGRAPH FINAL part349 Freds Inc TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .05; .25 mg/mg; mg/mg 55315-125_b3c48c8c-a0b4-4825-b142-957b68e52472 55315-125 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen LIQUID ORAL 20120222 ANDA ANDA079058 Fred's Inc. IBUPROFEN 50 mg/1.25mL 55315-127_619bb643-dad6-40c1-8496-160ca6687798 55315-127 HUMAN OTC DRUG DiBromm with PE Dimetapp LIQUID ORAL 20120101 OTC MONOGRAPH FINAL part341 Fred's BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 55315-129_fabe236f-5194-4c54-ae74-1378b176f2bb 55315-129 HUMAN OTC DRUG Cetirizine HCL 10 mg All Day Allergy Relief Cetirizine Hydrochloride TABLET ORAL 20130301 ANDA ANDA078780 Freds Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 55315-140_efb5146b-aee3-4555-a7e0-4fce2335fbb5 55315-140 HUMAN OTC DRUG Laxative pills maximum strength Sennosides TABLET ORAL 20100708 OTC MONOGRAPH NOT FINAL part334 Freds Inc SENNOSIDES 25 mg/1 55315-159_c526a30b-fd33-48bd-9dfa-478aca0722a7 55315-159 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 55315-163_61d0ed68-1f12-408c-ba99-d9f120ded09a 55315-163 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20120628 OTC MONOGRAPH FINAL part355 Fred's Inc SODIUM FLUORIDE 1 mg/mL 55315-165_c990bff4-e0fc-43ff-a450-d875d37ee294 55315-165 HUMAN OTC DRUG Ibuprofen PM Ibuprofen and Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20110610 ANDA ANDA090397 Freds Inc DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25; 200 mg/1; mg/1 55315-179_5479b0da-51dc-49fa-8bb0-1a673e91fb5b 55315-179 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin-b sulfate OINTMENT TOPICAL 20090501 OTC MONOGRAPH FINAL part333B Fred's Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 55315-183_8c44e290-a13a-4cae-ab21-a84f9ada3858 55315-183 HUMAN OTC DRUG Menstrual Relief Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20121015 OTC MONOGRAPH NOT FINAL part343 Freds Inc ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 55315-184_4f306fac-ab73-4901-9ebd-ae97f3029e93 55315-184 HUMAN OTC DRUG ANTIBACTERIAL FOAMING FRESH PEAR TRICLOSAN LIQUID TOPICAL 20110708 OTC MONOGRAPH NOT FINAL part333E FRED'S INC TRICLOSAN .46 mL/100mL 55315-185_c6aa50b8-8560-480f-8af5-6cce5e883904 55315-185 HUMAN OTC DRUG FREDS ANTIBACTERIAL FRESH PEAR TRICLOSAN LIQUID TOPICAL 20120925 OTC MONOGRAPH NOT FINAL part333E FREDS INC. TRICLOSAN .46 mg/100mL 55315-189_49730560-907c-4e91-a0e6-750634000fa5 55315-189 HUMAN OTC DRUG Somnitab Diphenhydramine HCl TABLET ORAL 19921225 OTC MONOGRAPH FINAL part341 FRED'S, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55315-190_c3553c4f-9b27-4ded-be5b-78c034290f3f 55315-190 HUMAN OTC DRUG Laxative Bisacodyl TABLET, COATED ORAL 20100708 OTC MONOGRAPH NOT FINAL part334 Freds Inc BISACODYL 5 mg/1 55315-199_5695f5d4-65f1-4692-a547-6fe85ded3880 55315-199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130413 ANDA ANDA078682 Freds Inc IBUPROFEN 200 mg/1 55315-211_a7d6fbdf-766d-48ac-8c94-9bf137e5958e 55315-211 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20130801 NDA NDA022429 Freds Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 55315-225_a87f0d80-f176-4bf6-8d97-fc2080c4dff0 55315-225 HUMAN OTC DRUG Nighttime Sleep Aid Non Habit Forming Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130411 OTC MONOGRAPH FINAL part341 Freds Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55315-227_fc050377-da40-468a-b7df-d92fd9da6088 55315-227 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130308 OTC MONOGRAPH FINAL part343 Freds Inc ASPIRIN 81 mg/1 55315-229_62119158-7ea2-4ec4-b356-b6e45e9823f2 55315-229 HUMAN OTC DRUG Non-Aspirin PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20100708 OTC MONOGRAPH FINAL part338 Freds Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55315-230_b28bff2b-7a85-4b6b-96a1-192ce3c1f4fd 55315-230 HUMAN OTC DRUG Sleep-Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20130315 OTC MONOGRAPH FINAL part341 Freds Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 55315-236_089c7929-3a13-4422-b7be-2998ee210aeb 55315-236 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Freds Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 55315-238_92855cbb-ed6a-43b6-a40d-df0fede577d1 55315-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 Freds Inc DOCUSATE SODIUM 100 mg/1 55315-242_795acb64-f97a-4b95-a043-6d3e319e169b 55315-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH FINAL part347 Freds Inc DIMETHICONE 125 mg/1 55315-245_bf1c2061-7faa-4a8e-a204-af843d0037c3 55315-245 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20140331 OTC MONOGRAPH NOT FINAL part334 Freds Inc SENNOSIDES 25 mg/1 55315-250_4a3fc395-654b-4156-9541-4e0918cb4dfb 55315-250 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 20130301 OTC MONOGRAPH FINAL part340 Freds Inc CAFFEINE 200 mg/1 55315-251_9ebf69da-e28d-415e-8558-165c4864ad92 55315-251 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 20140328 OTC MONOGRAPH FINAL part340 Freds Inc CAFFEINE 200 mg/1 55315-255_8aa13423-ed51-4be6-8d1c-5e5052a61b62 55315-255 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140328 ANDA ANDA091353 Freds Inc NAPROXEN SODIUM 220 mg/1 55315-256_54111468-e0cc-4ab1-8b21-47c3aa7ee607 55315-256 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140831 ANDA ANDA091353 Freds Inc NAPROXEN SODIUM 220 mg/1 55315-262_fae04cf4-f846-4660-b9bf-f54bd391602a 55315-262 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20080324 ANDA ANDA074916 Fred's Inc. IBUPROFEN 100 mg/5mL 55315-291_cb825e5b-1752-45d4-a644-215f9ba759b3 55315-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 FRED'S, INC. IBUPROFEN 200 mg/1 55315-292_49c41ae7-9427-4119-afb7-00161c04f8ac 55315-292 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, COATED ORAL 19880524 ANDA ANDA075010 FRED'S, INC. IBUPROFEN 200 mg/1 55315-298_958ef499-388d-45ce-9473-533927d2cb33 55315-298 HUMAN OTC DRUG Senna Laxative Sennosides TABLET ORAL 19950127 OTC MONOGRAPH NOT FINAL part334 FRED'S, INC. SENNOSIDES 8.6 mg/1 55315-326_934276b2-384c-47f3-8f1d-7e5f03708e13 55315-326 HUMAN OTC DRUG Womens Gentle Laxative Bisacodyl TABLET, COATED ORAL 20050212 OTC MONOGRAPH NOT FINAL part334 FRED'S, INC. BISACODYL 5 mg/1 55315-329_f8c123bd-51fe-4620-94e1-fec87abe7761 55315-329 HUMAN OTC DRUG Allergy Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 FRED'S, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55315-333_4f70b3db-763c-4719-8111-c0aec85b2c9b 55315-333 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20040430 ANDA ANDA076200 Fred's Inc. ACETAMINOPHEN 650 mg/1 55315-336_3a185409-67de-4976-aa27-fdd8f58e7622 55315-336 HUMAN OTC DRUG Freds Hemorrhoidal Mineral Oil, Petrolatum, Phenylephrine Hydrochloride CREAM TOPICAL 20140103 OTC MONOGRAPH FINAL part346 Freds, Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 55315-341_9b610b2d-40d8-4df1-bbb3-3811e02b744e 55315-341 HUMAN OTC DRUG Hydrocortisone Maximum Strength Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 20090501 OTC MONOGRAPH NOT FINAL part348 Fred's Inc. HYDROCORTISONE 1 g/100g 55315-343_26d67fe7-5983-46f9-a8c3-14b305f8b840 55315-343 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part348 FREDS, INC HYDROCORTISONE 1 g/100g 55315-351_628e9778-4502-45f3-87d8-9a45388ae666 55315-351 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20120330 ANDA ANDA200536 Fred's Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 55315-352_b1e38847-000e-4d7f-8b6f-d4252c2884f3 55315-352 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130901 ANDA ANDA201745 Fred's Inc. RANITIDINE HYDROCHLORIDE 75 mg/1 55315-360_83ae4ea2-3e31-4984-8d8f-0d03e3c70e05 55315-360 HUMAN OTC DRUG NON ASPIRIN PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20121130 OTC MONOGRAPH FINAL part338 Freds Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55315-386_af7e03c7-314b-4597-af54-e8193b42ba69 55315-386 HUMAN OTC DRUG Nighttime Fast Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 FRED'S, INC. DOXYLAMINE SUCCINATE 25 mg/1 55315-393_2c4ba8ef-84aa-4e14-8343-d41c22ffe5c7 55315-393 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, COATED ORAL 20020408 ANDA ANDA075139 FRED'S, INC. IBUPROFEN 200 mg/1 55315-404_258afc2b-f77a-491a-8e77-dc82c43a25d0 55315-404 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20141130 OTC MONOGRAPH FINAL part338 Freds Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55315-411_c949855c-01b9-4968-a074-63c296ccf2ee 55315-411 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate and Dextromethorphan HBr TABLET ORAL 20030503 OTC MONOGRAPH FINAL part341 FRED'S, INC. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 55315-453_88f5c61e-2619-4a08-9c08-3dc9bd4b3e68 55315-453 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine HCl TABLET, COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 FRED'S, INC. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 55315-455_b08a3eba-db5b-4518-8b1a-d57a476cac54 55315-455 HUMAN OTC DRUG Non-Aspirin Sinus Congestion and Pain Acetaminophen, Chlorpheniramine Maleate and Phenylephrine HCl TABLET ORAL 20060530 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 55315-466_7f0ab579-6b39-4f4e-a5a3-07a9f964a783 55315-466 HUMAN OTC DRUG Non-Drowsy Sinus Congestion and Pain Acetaminophen and Phenylephrine HCl TABLET ORAL 20050726 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 55315-470_a329d3fa-94e3-44af-899f-0efce90074c9 55315-470 HUMAN OTC DRUG Non Drowsy Day Time cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20120702 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 55315-473_cccd8c03-d015-4d65-8803-c031922ab6f9 55315-473 HUMAN OTC DRUG Nighttime Cold Head Congestion Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl CAPSULE ORAL 20050721 OTC MONOGRAPH FINAL part341 FRED'S, INC. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 55315-480_62517b5a-3110-4840-9fe1-d2b94048ef4b 55315-480 HUMAN OTC DRUG Night time multi symptom cold/flu relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20120702 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 55315-503_652e3bf9-3757-4aed-8e64-df3d215d0c6c 55315-503 HUMAN OTC DRUG Non-Drowsy Cold Multi-Symptom Severe Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED ORAL 20050804 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. 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PERMETHRIN 1 mg/100mL 55315-525_5a35ca2a-812d-4f99-aca3-95293b831e3b 55315-525 HUMAN OTC DRUG Anti-Itch Maximum Strength diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20080808 OTC MONOGRAPH NOT FINAL part348 Fred's Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; 1 mg/g; mg/g 55315-527_652d3529-4727-4126-a220-1d723737639e 55315-527 HUMAN OTC DRUG Non-Drowsy Sinus Congestion and Pain Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, COATED ORAL 20050806 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 55315-528_e6b4ba46-231b-4cf7-bbd4-f0c506d9930a 55315-528 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Fred's Inc. LORATADINE 10 mg/1 55315-529_cf0be8c3-50d2-4b7f-8120-33754890e2b2 55315-529 HUMAN OTC DRUG Loratadine OD Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Fred's Inc. LORATADINE 10 mg/1 55315-530_7e8139eb-0129-4596-b29b-49260161b53a 55315-530 HUMAN OTC DRUG Anti-Gas Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20130315 OTC MONOGRAPH FINAL part332 Freds Inc DIMETHICONE 180 mg/1 55315-531_a87eaa08-5bb4-4ee4-80a3-cafdc08b2a75 55315-531 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen TABLET ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN 500 mg/1 55315-550_9130b348-455c-4f94-a77b-53a70ce56862 55315-550 HUMAN OTC DRUG Gas Relief SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20120829 OTC MONOGRAPH FINAL part332 Freds Inc DIMETHICONE 125 mg/1 55315-552_fae04cf4-f846-4660-b9bf-f54bd391602a 55315-552 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Fred's Inc. IBUPROFEN 100 mg/5mL 55315-557_dbd16fd9-90d5-40d0-b4a8-d1de322b1714 55315-557 HUMAN OTC DRUG Extra Strength Pain Reliever PM Acetaminophen, Diphenhydramine HCl CAPSULE, GELATIN COATED ORAL 20071217 OTC MONOGRAPH FINAL part341 FRED'S, INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55315-558_3ac4d232-37f3-4be5-a821-6f4c92402645 55315-558 HUMAN OTC DRUG Non-Drowsy Sinus Congestion and Pain Acetaminophen and Phenylephrine HCl CAPSULE ORAL 20080317 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 55315-559_8eab7e4f-474a-4eac-816d-8285af823367 55315-559 HUMAN OTC DRUG Allergy Multi-Symptom Relief Acetaminophen, Phenylephrine HCl, Chlorpheniramine maleate CAPSULE, GELATIN COATED ORAL 20080317 OTC MONOGRAPH FINAL part341 FRED'S, INC. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 55315-560_67e4826b-fade-4883-be9a-7e979cd46543 55315-560 HUMAN OTC DRUG Cold Multi-Symptom Daytime Acetaminophen, Phenylephrine HCl and Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20080329 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 55315-600_231ce568-eecb-48de-bd1e-8059fd1c37d5 55315-600 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ASPIRIN 81 mg/1 55315-630_07554fa8-ba4b-444f-b8b8-ea06eb77d369 55315-630 HUMAN OTC DRUG Motion Sickness Dimenhydrinate TABLET ORAL 20100708 OTC MONOGRAPH FINAL part336 Freds Inc DIMENHYDRINATE 50 mg/1 55315-690_be367117-5b4a-4dc3-ac9a-bf9c62d05584 55315-690 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl TABLET ORAL 20100722 OTC MONOGRAPH FINAL part336 Freds Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55315-720_903905b0-dd10-47b3-bd02-428ba3a66026 55315-720 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110726 OTC MONOGRAPH NOT FINAL part333E FRED'S INC TRICLOSAN .115 mL/100mL 55315-721_71c993e5-17ba-4f90-a936-b95ecc367230 55315-721 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130408 OTC MONOGRAPH FINAL part341 Freds Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55315-730_8c07a5b2-38eb-4a85-abc0-8c0e7da6d571 55315-730 HUMAN OTC DRUG Miconazole 7 miconazole nitrate CREAM VAGINAL 20090609 ANDA ANDA074164 Fred's MICONAZOLE NITRATE 2 g/100g 55315-731_42105815-e690-4a79-bd5b-35daa9ad89ec 55315-731 HUMAN OTC DRUG Miconazole 3 Combination Pack Miconazole Nitrate KIT 20090609 ANDA ANDA074926 Fred's Inc. 55315-809_b3041323-f129-4e24-a1ed-ca02c139c077 55315-809 HUMAN OTC DRUG Alcohol Isopropyl Alcohol SWAB TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333A Fred's Inc. ISOPROPYL ALCOHOL 70 mL/100mL 55315-822_23669550-1925-4c57-beb4-cf9a4a0d3796 55315-822 HUMAN OTC DRUG Double Antibiotic Plus Pain Relief Maximum Strength Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20090501 OTC MONOGRAPH NOT FINAL part347 Fred's Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 55315-823_046d7414-0be8-444d-83b4-1af9a78cdc71 55315-823 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Maximum Strength bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride OINTMENT TOPICAL 20090501 OTC MONOGRAPH FINAL part333B Fred's Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 55316-001_ab322ce9-a345-40fc-85ac-8872566b78f4 55316-001 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20131214 OTC MONOGRAPH NOT FINAL part348 DZA Brands LLC MENTHOL 1.5 mg/g 55316-002_54477a96-7de1-480a-a2b8-5430617d6a27 55316-002 HUMAN OTC DRUG healthy accents enema Saline ENEMA RECTAL 20100107 OTC MONOGRAPH NOT FINAL part334 DZA Brands LLC SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 55316-008_534e7edb-39b3-4efc-abfd-68417391c110 55316-008 HUMAN OTC DRUG healthy accents pain relief infants Acetaminophen SUSPENSION/ DROPS ORAL 20080211 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ACETAMINOPHEN 80 mg/.8mL 55316-016_cd4aefae-0b84-41ed-859d-ff83ba31b3e4 55316-016 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20131230 OTC MONOGRAPH NOT FINAL part343 Healthy Accents (DZA Brands, LLC) ACETAMINOPHEN 500 mg/1 55316-029_1a827457-8c3c-442b-8ff4-a31ebce6aedb 55316-029 HUMAN OTC DRUG healthy accents nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20110606 ANDA ANDA076775 DZA Brands LLC NICOTINE 2 mg/1 55316-041_696db438-044c-4d1f-ab79-016b0c02e231 55316-041 HUMAN OTC DRUG Healthy Accents Nighttime Cold and Flu acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20080129 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 55316-046_e2e5e5a9-b61b-476a-a612-e3af094fcf20 55316-046 HUMAN OTC DRUG healthy accents pain relief Acetaminophen TABLET, COATED ORAL 20100401 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ACETAMINOPHEN 500 mg/1 55316-047_91a219fc-d8be-4f79-980a-8627ae15657f 55316-047 HUMAN OTC DRUG healthy accents ranitidine Ranitidine TABLET ORAL 20081112 ANDA ANDA078653 DZA Brands LLC RANITIDINE HYDROCHLORIDE 150 mg/1 55316-049_d2ecd233-b86d-45f0-b8bd-2818eb167a13 55316-049 HUMAN OTC DRUG Healthy Accents muscle ultra strength Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20100825 OTC MONOGRAPH NOT FINAL part348 DZA Brands LLC CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g 55316-050_916a0693-8830-4d48-ab34-a770bb2e221c 55316-050 HUMAN OTC DRUG healthy accents ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090415 ANDA ANDA079113 DZA Brands LLC DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 55316-054_8e2f715e-ee3d-4f6d-9a65-a28a50cdf9c1 55316-054 HUMAN OTC DRUG Healthy Accents 12 Hour Nasal Decongestant maximum strength Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110719 ANDA ANDA075153 DZA Brands LLC PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 55316-055_3f0f16b7-2768-41a4-8bb4-069bffcf291a 55316-055 HUMAN OTC DRUG HOME 360 moist Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A DZA BRANDS LLC BENZALKONIUM CHLORIDE .115 g/1 55316-056_3762c8be-59b0-410b-a801-6422cdaea89a 55316-056 HUMAN OTC DRUG healthy accents nighttime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140213 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 55316-057_4023fb65-10c0-4602-bd3c-f8f6c86fc93a 55316-057 HUMAN OTC DRUG healthy accents ibuprofen infants ibuprofen SUSPENSION ORAL 20080218 ANDA ANDA075217 DZA Brands LLC IBUPROFEN 50 mg/1.25mL 55316-063_7b58418f-7b00-4069-ae51-3a4b0ea008d5 55316-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 20080205 OTC MONOGRAPH FINAL part346 DZB Brands, LLC FERRIC OXIDE RED; ZINC OXIDE .8; .8 kg/100L; kg/100L 55316-065_3b9ed8c9-9b16-4b8e-a2d3-4db418f7412a 55316-065 HUMAN OTC DRUG healthy accents nasal Oxymetazoline HCl SPRAY NASAL 20080224 OTC MONOGRAPH FINAL part341 DZA Brands LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 55316-067_00a92032-2d1e-4685-8cb6-f90a326ba3f7 55316-067 HUMAN OTC DRUG Healthy Accents triple antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20100922 OTC MONOGRAPH FINAL part333B DZA Brands LLC BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 55316-069_4b815195-d0d5-4405-b42c-0e9626842458 55316-069 HUMAN OTC DRUG Pure petroleum White Petrolatum JELLY TOPICAL 20090105 OTC MONOGRAPH FINAL part347 DZA Brands LLC PETROLATUM 1 g/g 55316-072_9fd843df-4f1d-43a0-9ad3-582c6b699cba 55316-072 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol MOUTHWASH ORAL 20010629 OTC MONOGRAPH NOT FINAL part348 DZA Brands, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 55316-081_c766b61f-f578-43c4-8a4f-abc6582cf6b0 55316-081 HUMAN OTC DRUG healthy accents miconazole 3 Miconazole nitrate KIT 20080401 ANDA ANDA075329 DZA Brands LLC 55316-090_8dc9327a-4cd9-4943-8661-83042cb3208b 55316-090 HUMAN OTC DRUG healthy accents day time night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20080401 OTC MONOGRAPH FINAL part341 DZA Brands LLC 55316-090_b1390e77-e713-43c6-b65d-2f09307c7f13 55316-090 HUMAN OTC DRUG healthy accents daytime nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110517 OTC MONOGRAPH FINAL part341 DZA Brands LLC 55316-090_d52e7047-6dca-42ce-a835-a976982c10eb 55316-090 HUMAN OTC DRUG Healthy Accents Nighttime Daytime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20121108 OTC MONOGRAPH FINAL part341 DZA Brands LLC 55316-094_705f71ad-f3e3-44f2-98e2-5a83412689a4 55316-094 HUMAN OTC DRUG healthy accents nasal decongestant maximum strength Phenylephrine Hydrochloride TABLET ORAL 20080401 OTC MONOGRAPH FINAL part341 DZA Brands LLC PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 55316-105_57ab51d1-495b-45c8-b278-4e1bd3a15386 55316-105 HUMAN OTC DRUG healthy accents pain relief childrens Acetaminophen SUSPENSION ORAL 20080517 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ACETAMINOPHEN 160 mg/5mL 55316-117_4a3f2165-92d7-4c27-9fa7-104cd91dd402 55316-117 HUMAN OTC DRUG healthy accents lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 DZA Brands LLC LANSOPRAZOLE 15 mg/1 55316-130_4d6f773f-7b25-470a-a884-4a9e0e68cd59 55316-130 HUMAN OTC DRUG healthy accents pain relief Acetaminophen SUSPENSION ORAL 20110606 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ACETAMINOPHEN 160 mg/5mL 55316-131_961c9489-0086-404c-ad82-b3018fc74d15 55316-131 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20121211 ANDA ANDA078682 Healthy Accents (DZA Brands, LLC) IBUPROFEN 200 mg/1 55316-140_5f47fcd4-1b92-4ee6-9073-8502455a1008 55316-140 HUMAN OTC DRUG Healthy Accents Naproxen Sodium Naproxen sodium TABLET, FILM COATED ORAL 20130522 ANDA ANDA074661 DZA Brands LLC NAPROXEN SODIUM 220 mg/1 55316-141_77faeb77-33bc-4a46-87f6-8e146f43a167 55316-141 HUMAN OTC DRUG Healthy Accents Famotidine Famotidine TABLET ORAL 20091210 ANDA ANDA075400 DZA Brands LLC FAMOTIDINE 10 mg/1 55316-145_b0269c03-626c-46f2-8ce8-882dc96d27ee 55316-145 HUMAN OTC DRUG Healthy Accents Mucus Relief cold and sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130624 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 55316-153_314aff12-8535-4d17-a95c-f2c5b83d987c 55316-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H DZA Brands, LLC PYRITHIONE ZINC 1 kg/100L 55316-154_00e56821-808c-4da9-925a-5c43d36e2f09 55316-154 HUMAN OTC DRUG Flu Relief Therapy Night Time PHENYLEPHRINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, Acetaminphen LIQUID ORAL 20090708 OTC MONOGRAPH FINAL part341 Food Lion ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL 55316-155_d103b4b3-61d0-479b-be56-4cf0343b931b 55316-155 HUMAN OTC DRUG Flu Relief Therapy Day Time Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Food Lion ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 55316-156_6c398032-10e2-41b7-9e33-7b814c5e09e1 55316-156 HUMAN OTC DRUG Cough Relief DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20090708 OTC MONOGRAPH FINAL part341 Food Lion DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 55316-157_1cecf5d8-f8b4-4053-9496-9ea9d1f49777 55316-157 HUMAN OTC DRUG ChildrensRelief Expectorant Grape GUAIFENESIN LIQUID ORAL 20090923 OTC MONOGRAPH FINAL part341 Food Lion GUAIFENESIN 100 mg/5mL 55316-158_400b0d60-b4b2-46fa-9882-549f6c5cd15b 55316-158 HUMAN OTC DRUG Childrens Relief Cherry DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20090921 OTC MONOGRAPH FINAL part341 Food Lion DEXTROMETHORPHAN HYDROBROMIDE; 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PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 55316-190_becfd268-1f13-446f-b9e0-f7f48787efb4 55316-190 HUMAN OTC DRUG Laxative Bisacodyl TABLET, COATED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 Healthy Accents (DZA Brands, LLC) BISACODYL 5 mg/1 55316-194_c3dc2fbc-ac4d-4612-b788-9b6168889f16 55316-194 HUMAN OTC DRUG Healthy Accents Famotidine maximum strength Famotidine TABLET ORAL 20080413 ANDA ANDA077351 DZA Brands LLC FAMOTIDINE 20 mg/1 55316-198_ec5b32ef-f68d-48f8-9838-cc26d6ce4de0 55316-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130415 ANDA ANDA078682 Healthy Accents (DZA Brands, LLC) IBUPROFEN 200 mg/1 55316-205_71155d60-187b-4722-8332-d38f0ec5279e 55316-205 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20080508 OTC MONOGRAPH FINAL part358H DZA Brands, LLC COAL TAR 5 mg/mL 55316-213_29f9fc98-f7df-4f41-9c22-12b926e4cfe8 55316-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20110107 OTC MONOGRAPH FINAL part355 DZA Brands, LLC SODIUM FLUORIDE .05 kg/100L 55316-214_582ed8ce-f241-446d-8974-589792f58423 55316-214 HUMAN OTC DRUG healthy accents miconazole 7 Miconazole nitrate CREAM VAGINAL 20080303 ANDA ANDA074760 DZA Brands LLC MICONAZOLE NITRATE 2 g/100g 55316-215_eccbf624-b067-441a-b6ba-2f9fef9f8be2 55316-215 HUMAN OTC DRUG healthy accents daytime cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130108 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 55316-223_f48d1aa4-0ae4-4ce7-bf2e-0263e5d07570 55316-223 HUMAN OTC DRUG HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110623 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS LLC ALCOHOL 62 mL/100mL 55316-224_3749411c-423e-4e3b-b017-f8656399f4d3 55316-224 HUMAN OTC DRUG healthy accents anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20080204 ANDA ANDA075232 DZA Brands LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 55316-225_e253eed3-880d-4f9f-98be-3b8304a0c0fc 55316-225 HUMAN OTC DRUG HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20111013 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS ALCOHOL 62 mL/100mL 55316-227_b7eae08f-e124-4424-a9be-c851d8976e3f 55316-227 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130301 OTC MONOGRAPH FINAL part343 Healthy Accents (DZA Brands, LLC) ASPIRIN 81 mg/1 55316-234_935864d5-3971-40c4-8e08-0f1a0193ec50 55316-234 HUMAN OTC DRUG Healthy Accents cold head congestion daytime non drowsy Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20080524 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 55316-243_b3ba7739-2ab7-492b-a689-135b9f06e740 55316-243 HUMAN OTC DRUG Antibacterial Hand Triclosan LIQUID TOPICAL 20090105 OTC MONOGRAPH FINAL part333A DZA Brands LLC TRICLOSAN .15 kg/100L 55316-249_c9b6af6f-7e96-499e-befd-2f7deff7f2cb 55316-249 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20131230 ANDA ANDA079174 Healthy Accents (DZA Brands, LLC) IBUPROFEN 200 mg/1 55316-253_d394b7d9-cc74-4862-a732-a82f17ec256c 55316-253 HUMAN OTC DRUG HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20130528 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS LLC ALCOHOL 650 mg/mL 55316-255_a319b9d7-36e5-449d-8683-6c024a7a4d9b 55316-255 HUMAN OTC DRUG healthy accents ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20110606 ANDA ANDA075217 DZA Brands LLC IBUPROFEN 50 mg/1.25mL 55316-267_7c2a44be-8b78-4d91-9ef0-cc4268d7435f 55316-267 HUMAN OTC DRUG HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20111012 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS ALCOHOL 65 mL/100mL 55316-267_820e4223-0313-4f28-adce-50ba3f869a53 55316-267 HUMAN OTC DRUG HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20111012 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS ALCOHOL 65 mL/100mL 55316-268_ae962ccf-4667-4058-ab89-d393f66a1fa6 55316-268 HUMAN OTC DRUG HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110314 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS LLC ALCOHOL 62 mL/100mL 55316-272_21bb6f40-0a73-4f5a-819a-4700cec35489 55316-272 HUMAN OTC DRUG healthy accents sinus congestion and pain day time Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20080310 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 55316-274_1132727e-2a0e-4e0c-ad47-5307de614fb5 55316-274 HUMAN OTC DRUG healthy accents aspirin Aspirin TABLET, CHEWABLE ORAL 20110606 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ASPIRIN 81 mg/1 55316-279_ea78ee9b-46c9-4c10-99e3-0b40652e659d 55316-279 HUMAN OTC DRUG healthy accents hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141030 OTC MONOGRAPH FINAL part346 DZA Brands LLC COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 55316-281_640f2fa2-a5ec-488c-8cdc-67c5dd738d4b 55316-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20080220 OTC MONOGRAPH FINAL part358H DZA Brands, LLC PYRITHIONE ZINC 1 kg/100L 55316-288_e861a244-224d-4c97-8761-450935de8737 55316-288 HUMAN OTC DRUG Healthy Accents Childrens Mucus Relief Guaifenesin LIQUID ORAL 20130710 OTC MONOGRAPH FINAL part341 DZA Brands LLC GUAIFENESIN 100 mg/5mL 55316-296_cbfdc191-0b1d-485b-9b82-39b420fe2415 55316-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20090602 OTC MONOGRAPH FINAL part358H DZA Brands, LLC PYRITHIONE ZINC 1 kg/100L 55316-299_faf46347-5d53-44b5-8191-32860e6bc0ef 55316-299 HUMAN OTC DRUG Healthy Accents Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130522 ANDA ANDA072096 DZA Brands LLC IBUPROFEN 200 mg/1 55316-300_267991a1-4948-4a4a-bd49-5f2015bf43c1 55316-300 HUMAN OTC DRUG Healthy Accents Tussin Cough Adult Dextromethorphan Hydrobromide LIQUID ORAL 20080122 OTC MONOGRAPH FINAL part341 DZA Brands LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL 55316-302_c4a4d492-ed93-4fba-88d4-7c4baa12b82e 55316-302 HUMAN OTC DRUG healthy accents stomach relief original strength Bismuth subsalicylate SUSPENSION ORAL 20080122 OTC MONOGRAPH FINAL part335 DZA Brands LLC BISMUTH SUBSALICYLATE 525 mg/30mL 55316-304_a85a4791-c479-4402-aede-5ebab083fddd 55316-304 HUMAN OTC DRUG healthy accents nasal original oxymetazoline hydrochloride SPRAY NASAL 20080401 OTC MONOGRAPH FINAL part341 DZA Brands LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 55316-306_82ec61e1-baeb-4d9f-ade8-8c6edfe498da 55316-306 HUMAN OTC DRUG healthy accents clear lax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091106 ANDA ANDA090685 DZA Brands LLC POLYETHYLENE GLYCOL 3350 17 g/17g 55316-309_d232bb39-c183-4da8-9f4a-6cb6e45482de 55316-309 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20080220 OTC MONOGRAPH FINAL part358H DZA Brands LLC PYRITHIONE ZINC 1 kg/100L 55316-310_f904dd80-43fd-444a-a187-6175d49af023 55316-310 HUMAN OTC DRUG healthy accents tussin chest congestion adult Guaifenesin SYRUP ORAL 20080129 OTC MONOGRAPH FINAL part341 DZA Brands LLC GUAIFENESIN 100 mg/5mL 55316-311_f2566c3a-d300-4a1f-9eed-8271f2ab7519 55316-311 HUMAN OTC DRUG Dandruff PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20050602 OTC MONOGRAPH FINAL part358H DZA Brands LLC PYRITHIONE ZINC 1 kg/100kg 55316-315_76b37d06-79d5-47b6-bd43-2e894d12dd28 55316-315 HUMAN OTC DRUG Healthy Accents Moisture Healing DIMETHICONE LOTION TOPICAL 20100625 OTC MONOGRAPH FINAL part347 DZA Brands LLC DIMETHICONE 1 mL/100mL 55316-318_2ef0d17e-c747-44d5-860a-ac13ea4560bf 55316-318 HUMAN OTC DRUG Antiseptic EUCALYPTOL RINSE ORAL 20080205 OTC MONOGRAPH NOT FINAL part356 DZA Brands, LLC EUCALYPTOL; 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DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 55316-344_0cde3ddf-51a1-40d1-a7b7-7b6492408ca8 55316-344 HUMAN OTC DRUG Healthy Accents Nicotine Nicotine Polacrilex LOZENGE ORAL 20110606 ANDA ANDA077007 DZA Brands LLC NICOTINE 2 mg/1 55316-359_fc2171bb-bee5-4d55-b2e0-29c40e647413 55316-359 HUMAN OTC DRUG healthy accents tussin dm Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20080122 OTC MONOGRAPH FINAL part341 DZA Brands LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 55316-368_7736874e-1abd-4b1c-b032-f14400b697c1 55316-368 HUMAN OTC DRUG Healthy Accents All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 20080122 ANDA ANDA074661 DZA Brands LLC NAPROXEN SODIUM 220 mg/1 55316-374_41549501-94ac-41c9-ba73-dad07c4346a7 55316-374 HUMAN OTC DRUG Healthy Accents migraine formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20080310 ANDA ANDA075794 DZA Brands LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; 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DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 55316-516_d3db5c1b-481c-4860-a32e-67e5438613af 55316-516 HUMAN OTC DRUG healthy accents tussin cf Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20080204 OTC MONOGRAPH FINAL part341 DZA Brands LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 55316-517_935f8043-d64e-4eac-b2bb-57675e29b60a 55316-517 HUMAN OTC DRUG Healthy Accents ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090320 ANDA ANDA077349 DZA Brands LLC IBUPROFEN 200 mg/1 55316-533_7711bee1-e426-4852-b9b8-402f0c8f489e 55316-533 HUMAN OTC DRUG Healthy Accents athletes foot antifungal Tolnaftate CREAM TOPICAL 20100721 OTC MONOGRAPH FINAL part333C DZA Brands LLC TOLNAFTATE 1 g/100g 55316-535_5d8e35f8-ec1c-4dd5-9b58-c4784f4d885d 55316-535 HUMAN OTC DRUG Healthy Accents Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20080323 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ASPIRIN 81 mg/1 55316-541_5692eb8b-d09a-48b8-8813-83fe919b8878 55316-541 HUMAN OTC DRUG healthy accents cortisone maximum strength Hydrocortisone CREAM TOPICAL 20100825 OTC MONOGRAPH NOT FINAL part348 DZA Brands LLC HYDROCORTISONE 1 g/100g 55316-544_20b58095-ccb9-4e3d-b765-cf7164138385 55316-544 HUMAN OTC DRUG healthy accents arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080505 ANDA ANDA075077 DZA Brands LLC ACETAMINOPHEN 650 mg/1 55316-551_8b1fea8c-b300-4da7-8427-2e5b7a07d358 55316-551 HUMAN OTC DRUG Medicated Menthol, zinc oxide POWDER TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part348 DZB Brands, LLC MENTHOL; 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GUAIFENESIN 20; 200 mg/10mL; mg/10mL 55316-580_b25ccf0b-bd87-44fa-87a0-69b7153ada40 55316-580 HUMAN OTC DRUG Healthy Accents Daytime Nighttime Cold and Flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140530 OTC MONOGRAPH FINAL part341 DZA Brands LLC 55316-588_7fc9a221-7067-4eee-a40b-c7e02a03af1d 55316-588 HUMAN OTC DRUG Healthy Accents Maldroxal Aluminum Hydroxide, Magnesium Hydroxide, Simethicone LIQUID ORAL 20080122 OTC MONOGRAPH FINAL part332 DZA Brands LLC ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 55316-595_82f20350-a3e3-4ab9-8d2a-b789a92d3026 55316-595 HUMAN OTC DRUG Healthy Accents Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20080224 OTC MONOGRAPH FINAL part331 DZA Brands LLC CALCIUM CARBONATE 1000 mg/1 55316-599_d46679a8-312c-4e8e-bfcc-2c1fe8929d1e 55316-599 HUMAN OTC DRUG Healthy Accents Cold and Cough Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20140331 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 55316-602_777afabd-e603-4262-bb7d-a97dc03e96e8 55316-602 HUMAN OTC DRUG epsom salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20080227 OTC MONOGRAPH FINAL part334 DZA Brands, LLC MAGNESIUM SULFATE 1 g/g 55316-604_40603e6a-3931-4599-85f8-1d9002d91edb 55316-604 HUMAN OTC DRUG healthy accents ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20080122 ANDA ANDA072096 DZA Brands LLC IBUPROFEN 200 mg/1 55316-610_e9f02f5c-d588-4d7b-9c8c-32526c93b4fd 55316-610 HUMAN OTC DRUG HEALTHY ACCENTS MEDICATED DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20100929 OTC MONOGRAPH FINAL part358H DZA Brands LLC SELENIUM SULFIDE 1 mL/100mL 55316-612_1072dabd-dd03-4e77-a39d-dba0495daa92 55316-612 HUMAN OTC DRUG Healthy accents allergy relief Loratadine TABLET ORAL 20071215 ANDA ANDA076301 DZA Brands LLC LORATADINE 10 mg/1 55316-619_2e3eee79-4b5f-441d-a86c-510613ca9d37 55316-619 HUMAN OTC DRUG HEALTHY ACCENTS MEDICATED DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20140817 OTC MONOGRAPH FINAL part358H DZA BRANDS LLC SELENIUM SULFIDE 10 mg/mL 55316-620_7dcdc60d-4311-4aca-b632-9f45081bd2f0 55316-620 HUMAN OTC DRUG HEALTHY ACCENTS SELENIUM SULFIDE LIQUID TOPICAL 20130702 OTC MONOGRAPH FINAL part358H DZA BRANDS LLC SELENIUM SULFIDE 10 mg/mL 55316-621_f07bd5b3-dfa0-481c-94f6-41354d7df8f4 55316-621 HUMAN OTC DRUG Motion Sickness II Meclizine HCl TABLET ORAL 20131230 OTC MONOGRAPH FINAL part336 Healthy Accents (DZA Brands, LLC) MECLIZINE HYDROCHLORIDE 25 mg/1 55316-622_020e139a-6f0a-4c18-8169-d95e9b5dc7f4 55316-622 HUMAN OTC DRUG Healthy Accents Anti Itch Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20100721 OTC MONOGRAPH NOT FINAL part348 DZA Brands LLC DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 55316-647_03a64266-8989-4540-a8a4-377c8e00fd58 55316-647 HUMAN OTC DRUG Healthy Accents ibuprofen Ibuprofen TABLET, COATED ORAL 20080517 ANDA ANDA072096 DZA Brands LLC IBUPROFEN 200 mg/1 55316-648_85b704bd-2674-4e5f-be14-a42b9f84e478 55316-648 HUMAN OTC DRUG Healthy Accents Nasal Phenylephrine hydrochloride SPRAY NASAL 20080211 OTC MONOGRAPH FINAL part341 DZA Brands LLC PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 55316-656_3bd6d263-180c-4b2e-9acc-d57c2a9c022b 55316-656 HUMAN OTC DRUG healthy accents daytime acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20080129 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 55316-664_570deb8f-07bd-4f53-b0c6-9e12f739a28f 55316-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20080205 OTC MONOGRAPH NOT FINAL part356 DZA Brands LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 55316-666_b9fa134b-e0a6-4f90-a11d-fbd885df5704 55316-666 HUMAN OTC DRUG healthy accents cough and sore throat night time Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20080224 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 55316-667_e7b47646-52d6-4d73-b76f-c454ed37addf 55316-667 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20071022 OTC MONOGRAPH FINAL part334 DZA Brads, LLC MAGNESIUM CITRATE 1.745 g/29.6mL 55316-668_ee9172af-c6f2-443c-9e26-c80b06d1952c 55316-668 HUMAN OTC DRUG Healthy Accents Night Time Cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20080129 OTC MONOGRAPH FINAL part341 DZA Brands LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 55316-678_35d39af2-06a0-4f84-89be-6be239517f53 55316-678 HUMAN OTC DRUG Healthy accents hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20121024 OTC MONOGRAPH FINAL part346 DZA Brands LLC MINERAL OIL; 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PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 55316-742_5ea75f90-fd2b-40fc-815d-76f9ea810bde 55316-742 HUMAN OTC DRUG healthy accents naproxen sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20120405 NDA NDA021920 DZA Brands LLC NAPROXEN SODIUM 220 mg/1 55316-751_5f7ca12c-3be8-4bfc-9c86-17046c35d09a 55316-751 HUMAN OTC DRUG healthy accents pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120308 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55316-799_e85bf125-613e-4bc5-a6d9-f1f38032e5cd 55316-799 HUMAN OTC DRUG Healthy Accents Mucus Relief Severe Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140806 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 55316-801_58f95350-0364-4d6b-ac49-5cd971b24981 55316-801 HUMAN OTC DRUG Healthy Accents Antibacterial Body Wash Spring Fresh Triclosan SOAP TOPICAL 20100922 OTC MONOGRAPH NOT FINAL part333E DZA Brands, LLC TRICLOSAN .15 mL/100mL 55316-822_620e4c20-6747-4e9d-9908-df8a78d52b97 55316-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 20080131 OTC MONOGRAPH FINAL part347 DZA Brands WITCH HAZEL 86 kg/100L 55316-825_2212a267-a506-4128-ae2f-f0eba2ce0b9b 55316-825 HUMAN OTC DRUG healthy accents miconazole 7 Miconazole nitrate CREAM VAGINAL 20141203 ANDA ANDA074760 DZA Brands LLC MICONAZOLE NITRATE 2 g/100g 55316-831_0e122c91-3aa6-46c3-aa62-f6d3699f84ed 55316-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 20071022 OTC MONOGRAPH NOT FINAL part334 DZA Brands LLC MINERAL OIL 999 mg/mL 55316-851_70066362-a953-4716-b9aa-acff09377a67 55316-851 HUMAN OTC DRUG healthy accents maldroxal Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20080129 OTC MONOGRAPH FINAL part332 DZA Brands LLC ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 55316-852_5ab20dff-97cb-43bc-ba68-91199e54cd0e 55316-852 HUMAN OTC DRUG Healthy Accents Ranitidine Ranitidine TABLET, FILM COATED ORAL 20131009 ANDA ANDA091429 DZA Brands LLC RANITIDINE HYDROCHLORIDE 150 mg/1 55316-871_ec6ec90a-2c64-49d0-a29f-a46d2b8d9edb 55316-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20090122 OTC MONOGRAPH NOT FINAL part333A DZA Brands, HYDROGEN PEROXIDE .3 kg/100L 55316-882_9d0fbdde-1685-45ba-8dda-e5d9f44078bf 55316-882 HUMAN OTC DRUG Healthy Accents Gas Relief Simethicone EMULSION ORAL 20080224 OTC MONOGRAPH FINAL part332 DZA Brands LLC DIMETHICONE 20 mg/.3mL 55316-886_8a3e5c67-b140-4d8e-83ba-1652c5f87e2d 55316-886 HUMAN OTC DRUG healthy accents sinus Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20080310 OTC MONOGRAPH FINAL part341 DZA Brands LLC 55316-886_b3a72956-198e-46cb-9c81-dc0c3ace3370 55316-886 HUMAN OTC DRUG healthy accents sinus congestion and pain daytime nighttime Acetaminophen,Phenylephrine HCl, Chlorpheniramine maleate KIT 20111010 OTC MONOGRAPH FINAL part341 DZA Brands LLC 55316-897_6f92dd09-e263-4756-9b67-d6a4f87bf47a 55316-897 HUMAN OTC DRUG healthy accents ibuprofen Ibuprofen SUSPENSION ORAL 20080303 ANDA ANDA074937 DZA Brands LLC IBUPROFEN 100 mg/5mL 55316-903_ed828d09-7bb6-4ff3-9f39-eafb68fa0717 55316-903 HUMAN OTC DRUG healthy accents multi symptom cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20110606 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 55316-906_4aff97fb-b7bd-4bb3-8ddf-ea80b6ee3726 55316-906 HUMAN OTC DRUG healthy accents cold and allergy childrens phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20080401 OTC MONOGRAPH FINAL part341 DZA Brands LLC BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 55316-908_107b380f-948b-4184-86a9-a4f8083e67ce 55316-908 HUMAN OTC DRUG healthy accents nighttime cold and flu acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20080129 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 55316-915_016f1afe-fba3-499a-a849-b3626734cc92 55316-915 HUMAN OTC DRUG healthy accents omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080303 NDA NDA022032 DZA Brands LLC OMEPRAZOLE 20 mg/1 55316-917_c7f9949a-fb1f-4c4a-9415-6d75514326bc 55316-917 HUMAN OTC DRUG healthy accents pain relief Acetaminophen CAPSULE, COATED ORAL 20110216 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ACETAMINOPHEN 500 mg/1 55316-922_c5535821-71b4-44d3-ad13-c8c743a809f0 55316-922 HUMAN OTC DRUG Healthy Accents Mucus Relief Severe Congestion and Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130619 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 55316-949_63246558-759b-4316-9cf0-9db677ab9088 55316-949 HUMAN OTC DRUG Healthy Accents Milk of Magnesia Magnesium hydroxide LIQUID ORAL 20080122 OTC MONOGRAPH NOT FINAL part334 DZA Brands LLC MAGNESIUM HYDROXIDE 1200 mg/15mL 55316-951_0b503b70-aae2-4415-a83f-4a1d52732f49 55316-951 HUMAN OTC DRUG Hand Sanitizer ALCOHOL GEL TOPICAL 20110520 OTC MONOGRAPH NOT FINAL part333A DZA Brands LLC ALCOHOL .65 kg/100L 55316-966_659e4c9d-6f5a-44e1-b542-0da533df3a3b 55316-966 HUMAN OTC DRUG Healthy Accents Arthritis Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130516 ANDA ANDA075077 DZA Brands LLC ACETAMINOPHEN 650 mg/1 55316-974_af8b2593-e3f5-4d51-a977-5c57da070adc 55316-974 HUMAN OTC DRUG healthy accents childrens allergy cetirizine hydrochloride LIQUID ORAL 20080428 ANDA ANDA090254 DZA Brands LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL 55316-977_1bbed6dd-3e45-46e3-8b1e-c988ddedce09 55316-977 HUMAN OTC DRUG Healthy Accents nighttime cold and flu Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20080524 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 55316-987_ee263bfc-9990-432f-9f65-7bfff0cf640a 55316-987 HUMAN OTC DRUG healthy accents cold and cough DM Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20080806 OTC MONOGRAPH FINAL part341 DZA Brands LLC BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 55316-994_dd3adcce-7e74-45b7-b7ce-e19b1c5326d4 55316-994 HUMAN OTC DRUG healthy accents daytime acetaminophen, dextromethorphan hbr, phenylephrine hcl CAPSULE, LIQUID FILLED ORAL 20080524 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 55316-998_a2ce4ea1-702f-4942-96d9-134701da6af9 55316-998 HUMAN OTC DRUG healthy accents allergy relief fexofenadine hcl TABLET, FILM COATED ORAL 20110615 ANDA ANDA076447 DZA Brands LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 55319-005_26911f36-3dc9-4858-aebf-53af5db2528a 55319-005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 FAMILY DOLLAR STORES, INC. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 55319-013_aa669e2c-aa36-4e91-8a42-d16f0a9e2720 55319-013 HUMAN OTC DRUG FAMILY DOLLAR Clinical Strength Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130730 OTC MONOGRAPH FINAL part350 FAMILY DOLLAR ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g 55319-014_5fe45576-8e75-4955-8221-a101f87c116c 55319-014 HUMAN OTC DRUG FAMILY DOLLAR Clinical Strength Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20111024 OTC MONOGRAPH FINAL part350 FAMILY DOLLAR ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g 55319-015_c6cc5487-dd66-4935-876b-7b024c72b22a 55319-015 HUMAN OTC DRUG Antacid Supreme Cherry ALUMINUM HYDROXIDE,MAGNESIUM HYDROXIDE SUSPENSION ORAL 20090107 OTC MONOGRAPH FINAL part331 Family Dollar ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE 400; 135 mg/5mL; mg/5mL 55319-022_53665d6a-f120-4d76-9839-eb051606f67b 55319-022 HUMAN OTC DRUG heartburn relief Cimetidine TABLET ORAL 20000918 ANDA ANDA075285 Family Dollar Services Inc CIMETIDINE 200 mg/1 55319-026_44a22089-975b-4f32-aa2a-ec2af7b1c0a9 55319-026 HUMAN OTC DRUG FAMILY WELLNESS COLD AND HOT PAIN RELIEF MENTHOL PATCH TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part348 FAMILY DOLLAR MENTHOL 750 mg/1 55319-031_a9bd4fd0-da7a-4fa1-b7e5-5b55b88a03e3 55319-031 HUMAN OTC DRUG FAMILY WELLNESS MEDICATED WIPES WITCH HAZEL SOLUTION TOPICAL 20120930 OTC MONOGRAPH FINAL part346 FAMILY DOLLAR WITCH HAZEL 5 g/1 55319-032_46b404c3-ab4c-467f-a4cb-117646c405c8 55319-032 HUMAN OTC DRUG FAMILY WELLNESS MEDICATED COOLING PADS WITCH HAZEL SOLUTION TOPICAL 20120930 OTC MONOGRAPH FINAL part346 FAMILY DOLLAR WITCH HAZEL 5 g/1 55319-033_aa9769e2-be94-443a-bb39-3ddb12ddd593 55319-033 HUMAN OTC DRUG FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE CREAM TOPICAL 20121015 OTC MONOGRAPH FINAL part333B FAMILY DOLLAR NEOMYCIN; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 55319-040_18d96a11-1d13-458f-8744-da72b44a0c4e 55319-040 HUMAN OTC DRUG Tussin DM Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20090701 OTC MONOGRAPH FINAL part341 Family Dollar DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 55319-041_b29c066b-42c0-49e4-a9aa-a76d8a93aa02 55319-041 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen CAPSULE ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN 500 mg/1 55319-042_a1c21ddb-715e-47a5-94b2-b23ffa56e038 55319-042 HUMAN OTC DRUG Night Time Cough Cherry DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20090217 OTC MONOGRAPH FINAL part341 Family Dollar DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 135 mg/15mL; mg/5mL 55319-050_1cfedf48-88b9-4022-97cf-3b8506fa534c 55319-050 HUMAN OTC DRUG ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20100407 ANDA ANDA079113 Family Dollar Services Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 55319-059_14e1c0a6-2081-4a1a-ba5f-e31c9463098b 55319-059 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20140630 OTC MONOGRAPH NOT FINAL part343 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN 500 mg/1 55319-063_74b661a5-9633-4a37-833c-689d8b2e5762 55319-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19890715 OTC MONOGRAPH FINAL part347 Family Dollar FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL 55319-064_d7e3ec80-3fb4-45e2-b75a-a146ac0561c4 55319-064 HUMAN OTC DRUG Family Wellness Acid Reducer Famotidine TABLET ORAL 20130919 ANDA ANDA075400 Family Dollar Services Inc FAMOTIDINE 10 mg/1 55319-069_e7a8455a-f65d-40df-a426-f97edad2522b 55319-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 20090105 OTC MONOGRAPH FINAL part347 Family Dollar Services, Inc PETROLATUM 1 g/g 55319-071_edb2bd27-78fa-4452-8d52-1cc1b48da3e8 55319-071 HUMAN OTC DRUG Isopropyl alcohol 50 percent Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A Family Dollar (FAMILY WELLNESS) ISOPROPYL ALCOHOL 50 mL/100mL 55319-072_dd10648b-e34f-493c-985c-47b5798000c5 55319-072 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 50 percent Wintergreen Isopropyl alcohol LIQUID TOPICAL 20140831 OTC MONOGRAPH NOT FINAL part333A Family Dollar (FAMILY WELLNESS) ISOPROPYL ALCOHOL 50 mL/100mL 55319-074_5a9ea866-0a01-4cbc-a807-15fc40158e35 55319-074 HUMAN OTC DRUG Family Wellness Maximum Strength Hydrocortisone Hydrocortisone CREAM TOPICAL 20130819 OTC MONOGRAPH NOT FINAL part348 Family Dollar HYDROCORTISONE 1 g/100g 55319-079_10260304-157a-4f61-9599-e34bf63f9cd1 55319-079 HUMAN OTC DRUG Childrens Cold and Cough Nighttime Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20141130 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 55319-081_bb1fc264-441b-41e3-a082-fb11897262c7 55319-081 HUMAN OTC DRUG Family Wellness Miconazole 3 Miconazole nitrate KIT 20130329 ANDA ANDA075329 Family Dollar Services Inc 55319-100_c185f1bf-5c07-4671-ad3b-bb52f07cbe2a 55319-100 HUMAN OTC DRUG Medicated Chest Rub Camphor, Menthol, Eucalyptus Oil CREAM TOPICAL 20110719 OTC MONOGRAPH FINAL part348 Family Dollar Services Inc CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 g/100g; g/100g; g/100g 55319-101_63c985b3-51d5-48a8-9ca3-1866b616b7ff 55319-101 HUMAN OTC DRUG Medicated Chest Rub Family Wellness Camphor, Menthol, Eucalyptus Oil CREAM TOPICAL 20110719 OTC MONOGRAPH FINAL part348 Family Dollar Services Inc CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 g/100g; g/100g; g/100g 55319-102_3de44bf1-2c86-498c-8ca8-429e762ae647 55319-102 HUMAN OTC DRUG MEDICATED CHEST RUB camphor, menthol, eucalyptus oil CREAM TOPICAL 20110719 OTC MONOGRAPH NOT FINAL part348 Family Dollar Services Inc CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 g/100g; g/100g; g/100g 55319-107_3e42fa27-ddac-41cb-bcc7-4715e20457fd 55319-107 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20140731 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) GUAIFENESIN 400 mg/1 55319-109_50da6caa-86f1-4709-b9e5-509daf80d54e 55319-109 HUMAN OTC DRUG Mucus Relief DM Guaifenesin, Dextromethorphan HBr TABLET ORAL 20140731 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 55319-110_44fe61df-cfc8-4962-afc2-43a2e3b7fce4 55319-110 HUMAN OTC DRUG Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 20120223 OTC MONOGRAPH FINAL part333B Family Dollar Services Inc. BACITRACIN ZINC 500 [USP'U]/g 55319-125_6c630a1b-de04-4906-8e89-b7dbd0b91a7a 55319-125 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060804 ANDA ANDA074916 Family Dollar Services Inc. IBUPROFEN 100 mg/5mL 55319-130_ad4862b2-f095-499e-a86d-ed6870aca13f 55319-130 HUMAN OTC DRUG Family Dollar Antiseptic Mouth Rinse Blue Mint Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 20110516 OTC MONOGRAPH FINAL part356 Family Dollar Services Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100g; g/100g; g/100g; g/100g 55319-131_e3ac2c16-28e3-407a-b65d-d378b9dad916 55319-131 HUMAN OTC DRUG Family Dollar Antiseptic Mouth Rinse Spring Mint Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 20110516 OTC MONOGRAPH FINAL part356 Family Dollar EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100g; g/100g; g/100g; g/100g 55319-132_a65e0236-f9e1-4ab9-8246-f7f55d3d01cc 55319-132 HUMAN OTC DRUG Family Dollar Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 20110516 OTC MONOGRAPH FINAL part356 Family Dollar EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100g; g/100g; g/100g; g/100g 55319-133_838e902f-e536-45ee-9cce-cb64d7f52ea9 55319-133 HUMAN OTC DRUG Family Dollar Complete Protection Anticavity Mouthwash Sodium Fluoride MOUTHWASH ORAL 20110516 OTC MONOGRAPH FINAL part356 Family Dollar SODIUM FLUORIDE .0221 g/100g 55319-140_04ea89aa-28f7-4243-bf6a-f3429b22ba7b 55319-140 HUMAN OTC DRUG Night Time Cherry Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate LIQUID ORAL 20090317 OTC MONOGRAPH FINAL part341 Family Dollar ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 55319-141_29d5bef3-cd98-4ca6-98a0-3c72e9b6211c 55319-141 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20090630 OTC MONOGRAPH FINAL part341 Family Dollar DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 55319-143_2f9587d7-4f93-46e9-82c6-35c62ecb49da 55319-143 HUMAN OTC DRUG DiBromm with PE BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Family Dollar BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 55319-146_f5debb1b-7fc6-492e-a45d-5f9c9db3c75b 55319-146 HUMAN OTC DRUG Night Time Original Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate LIQUID ORAL 20051108 OTC MONOGRAPH FINAL part341 Family Dollar ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 55319-153_8c1efcb8-4f26-43d3-b52e-8103195abb5f 55319-153 HUMAN OTC DRUG Dandruff Daily Care Pyrithione Zinc SHAMPOO TOPICAL 19980605 OTC MONOGRAPH FINAL part358H Family Dollar Services, Inc PYRITHIONE ZINC 1 kg/100L 55319-154_10e1f279-bc6e-4e63-9012-ef14f4da599c 55319-154 HUMAN OTC DRUG 2in1 Dandruff and Conditioner pyrithione zinc SHAMPOO TOPICAL 20120715 OTC MONOGRAPH FINAL part358H Family Dollar PYRITHIONE ZINC 1 mL/100mL 55319-156_460f6eb5-e5e9-4829-bb6b-1cea31ceac54 55319-156 HUMAN OTC DRUG Family Dollar Antibacterial Triclosan SOAP TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. TRICLOSAN .15 g/100mL 55319-159_f57c401e-93a1-4dc8-b0ea-007fa0e29d8f 55319-159 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Family Dollar ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 55319-160_3effe95a-2d1d-471e-a9e2-368bac232662 55319-160 HUMAN OTC DRUG family wellness hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20121205 OTC MONOGRAPH FINAL part346 Family Dollar Services Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g 55319-161_95cc004b-5bf9-43d8-8995-0e1e725d3c90 55319-161 HUMAN OTC DRUG Family Dollar Foaming Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20131230 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. TRICLOSAN .46 g/100mL 55319-162_185f3c88-9e03-4106-bd13-38eae2155ec9 55319-162 HUMAN OTC DRUG Family Dollar Foaming Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20131230 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. TRICLOSAN .46 g/100mL 55319-163_48a301f4-6ea2-460f-a2d8-fa959108ed43 55319-163 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20111214 OTC MONOGRAPH FINAL part355 Family Dollar Services, Inc SODIUM FLUORIDE .1 mg/mL 55319-168_bc8b1b97-b60a-46ca-acee-12d098768a64 55319-168 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20120815 ANDA ANDA079096 Family Dollar (FAMILY WELLNESS) NAPROXEN SODIUM 220 mg/1 55319-169_1c51f689-7d38-4fb3-ae5e-f647a79b5898 55319-169 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20131101 ANDA ANDA079096 Family Dollar (FAMILY WELLNESS) NAPROXEN SODIUM 220 mg/1 55319-173_c36fa57c-1cf3-43af-bc35-ab58f8aeb09b 55319-173 HUMAN OTC DRUG Family wellness Lice Treatment Piperonyl Butoxide, Pyrethrum Extract KIT 20130625 OTC MONOGRAPH FINAL part358G Family Dollar Services Inc 55319-175_dc7d3961-9f70-457b-849b-2d41a7e0c80b 55319-175 HUMAN OTC DRUG Extra Strength Acetaminophen Acetaminophen TABLET ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 Family Dollar ACETAMINOPHEN 500 mg/1 55319-179_fb447f5f-4d68-4fc1-b9ad-8989bd71d021 55319-179 HUMAN OTC DRUG TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sulfate OINTMENT TOPICAL 20030101 OTC MONOGRAPH FINAL part333B Family Dollar Services Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 55319-190_23010a0a-6d55-40b9-b88b-b43ac9822be4 55319-190 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part336 Family Dollar DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55319-194_9e7cf1ab-1b4a-440f-9f47-69f37bab63b1 55319-194 HUMAN OTC DRUG Allergy Relief Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Family Dollar CHLORPHENIRAMINE MALEATE 4 mg/1 55319-195_b5089ed5-dce4-4825-b032-20b535f1a652 55319-195 HUMAN OTC DRUG Laxative Bisacodyl TABLET, COATED ORAL 20130630 OTC MONOGRAPH NOT FINAL part334 Family Dollar (FAMILY WELLNESS) BISACODYL 5 mg/1 55319-200_37d55a3d-8d2d-4b53-8d41-52b23025d48c 55319-200 HUMAN OTC DRUG Flu Relief Therapy Night Time Acetaminophen, DIPHENHYDRAMINE HYDROCHLORIDE and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Family Dollar ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL 55319-203_55fb4e33-648a-4ca2-ba8a-55a9abfda034 55319-203 HUMAN OTC DRUG FAMILY DOLLAR ACNE TREATMENT BENZOYL PEROXIDE CREAM TOPICAL 20120120 OTC MONOGRAPH FINAL part333D FAMILY DOLLAR BENZOYL PEROXIDE 10 g/100g 55319-205_5dea8e85-dcf1-46c4-bc30-e8ee2652d630 55319-205 HUMAN OTC DRUG Therapeutic T Plus Coal Tar SHAMPOO TOPICAL 20050304 OTC MONOGRAPH FINAL part358H Family Dollar Services Inc COAL TAR 25 mg/mL 55319-210_3e8f8535-75ed-4368-aada-8efac44a24b4 55319-210 HUMAN OTC DRUG Flu Relief Therapy Day Time Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20090630 OTC MONOGRAPH FINAL part341 Family Dollar ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 55319-212_97341677-d544-4595-9068-6cf9937f5631 55319-212 HUMAN OTC DRUG Pain Reliever Sleep Aid Extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20131104 OTC MONOGRAPH NOT FINAL part343 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55319-213_783f2c5b-a548-4c5a-a9b6-d088fc55ab48 55319-213 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20050223 OTC MONOGRAPH FINAL part355 Family Dollar Servicesm Inc SODIUM FLUORIDE .05 kg/100L 55319-218_3bfc20d8-6f56-466f-8a88-3e8894a5aecd 55319-218 HUMAN OTC DRUG Chewable Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 Family Dollar ASPIRIN 81 mg/1 55319-224_dca62593-20dd-49df-9100-c32e69acf860 55319-224 HUMAN OTC DRUG family wellness anti diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20030226 ANDA ANDA075232 Family Dollar Services Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 55319-225_a09ded9b-ee95-4860-b009-ae81f0ccd6ae 55319-225 HUMAN OTC DRUG EZ Nite Sleep Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55319-227_d9b66546-e0b7-459e-8423-9b359afe963b 55319-227 HUMAN OTC DRUG Low Dose Aspirin 81 mg Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 Family Dollar (FAMILY WELLNESS) ASPIRIN 81 mg/1 55319-235_747ec504-ca57-4f4a-8a6f-181c08ad2f71 55319-235 HUMAN OTC DRUG Extra Strength Pain Reliever PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 Family Dollar ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55319-236_590297a7-0888-490b-8b09-f49f5b5e334f 55319-236 HUMAN OTC DRUG Sleep Aid Nighttime Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 55319-237_e8d6f123-171b-4d93-a8a8-9c28f7454e02 55319-237 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl CAPSULE ORAL 20140731 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55319-238_28241d37-dbec-49c3-b86f-aa082c4cb416 55319-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130830 OTC MONOGRAPH NOT FINAL part334 Family Dollar (FAMILY WELLNESS) DOCUSATE SODIUM 100 mg/1 55319-240_d877edd8-bdb4-4717-893b-371a90d17eeb 55319-240 HUMAN OTC DRUG Family Dollar Roll-On Deodorant Aluminum Chlorohydrate LOTION TOPICAL 20140502 OTC MONOGRAPH FINAL part350 Family Dollar Services,Inc. ALUMINUM CHLOROHYDRATE 160 mg/mL 55319-241_6853a49f-69bf-4ef6-a737-b2600c478398 55319-241 HUMAN OTC DRUG Tussin CF DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20090630 OTC MONOGRAPH FINAL part341 Family Dollar DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 55319-242_cdca2d3e-7a6e-4cc6-b308-78af50dbb8b9 55319-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH FINAL part347 Family Dollar (FAMILY WELLNESS) DIMETHICONE 125 mg/1 55319-243_69b8d51a-5829-45ff-9412-c8a590eec617 55319-243 HUMAN OTC DRUG Antibacterial Hand Triclosan LIQUID TOPICAL 20090106 OTC MONOGRAPH FINAL part333A Family Dollar Services Inc TRICLOSAN .15 kg/100L 55319-244_5a4778b2-4a56-4791-8c19-4be287e10df1 55319-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH NOT FINAL part334 Family Dollar (FAMILY WELLNESS) DOCUSATE SODIUM 100 mg/1 55319-247_0125b07e-7d2f-40f7-9e67-03b9da21b24f 55319-247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 55319-248_3b0578b2-92a9-426d-9498-3dc560413583 55319-248 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20140630 ANDA ANDA079174 Family Dollar (FAMILY WELLNESS) IBUPROFEN 200 mg/1 55319-249_6740bc2d-1ad1-4d17-9f26-eeb13dad79f0 55319-249 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20140731 ANDA ANDA076460 Family Dollar (FAMILY WELLNESS) IBUPROFEN 200 mg/1 55319-250_b72fa3e9-efa1-40ce-aece-45b18175fd36 55319-250 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen SUSPENSION ORAL 20120222 ANDA ANDA079058 Family Dollar Services Inc. IBUPROFEN 50 mg/1.25mL 55319-255_6d2d8fdb-81d0-44b7-8feb-bdc3e35459fe 55319-255 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140430 ANDA ANDA091353 Family Dollar (FAMILY WELLNESS) NAPROXEN SODIUM 220 mg/1 55319-256_6851d122-a161-4fe6-8236-91f78b36bfc3 55319-256 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140430 ANDA ANDA091353 Family Dollar (FAMILY WELLNESS) NAPROXEN SODIUM 220 mg/1 55319-263_505cf071-0a72-43f9-bda1-b40440548590 55319-263 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20120223 ANDA ANDA074916 Family Dollar Services Inc. IBUPROFEN 100 mg/5mL 55319-268_be81e716-60fe-4881-85c5-be23ea9a5801 55319-268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20140831 OTC MONOGRAPH NOT FINAL part356 Family Dollar (FAMILY WELLNESS) HYDROGEN PEROXIDE 2.65 mL/100mL 55319-271_9861deef-7ed7-406a-aab6-eecf37642f62 55319-271 HUMAN OTC DRUG family wellness acid reducer Ranitidine TABLET ORAL 20120802 ANDA ANDA076760 Family Dollar Services Inc RANITIDINE HYDROCHLORIDE 75 mg/1 55319-272_f81b0b78-a358-43be-b85e-31981be1d6ff 55319-272 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A Family Dollar (FAMILY WELLNESS) ISOPROPYL ALCOHOL 70 mL/100mL 55319-277_a5fa8ad2-a52d-40ca-8cef-df3699374231 55319-277 HUMAN OTC DRUG Isopropyl alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A Family Dollar (FAMILY WELLNESS) ISOPROPYL ALCOHOL 91 mL/100mL 55319-279_970a6043-7302-4642-b33b-0f2502d85a24 55319-279 HUMAN OTC DRUG family wellness hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141029 OTC MONOGRAPH FINAL part346 Family Dollar Services Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 55319-291_453bf5a2-5368-4547-b1c0-de6fa39f64c6 55319-291 HUMAN OTC DRUG Film Coated Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 Family Dollar IBUPROFEN 200 mg/1 55319-292_9fb9282f-9079-4350-ba3a-66de7ff154f9 55319-292 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, COATED ORAL 19880524 ANDA ANDA075010 Family Dollar IBUPROFEN 200 mg/1 55319-299_ef7a2a94-bd4f-41dd-ae1f-88f1150550b1 55319-299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 20130502 OTC MONOGRAPH NOT FINAL part356 Family Dollar Services CETYLPYRIDINIUM CHLORIDE .7 mg/mL 55319-300_ab17d6c6-3336-43a7-a8a1-ff9e35cf2394 55319-300 HUMAN OTC DRUG Family Wellness Antifungal Tolnaftate CREAM TOPICAL 20140121 OTC MONOGRAPH FINAL part333C Family Dollar TOLNAFTATE 1 g/100g 55319-304_7d2871d2-6205-4c83-876b-0a74827d1b1f 55319-304 HUMAN OTC DRUG Childrens Plus Multi Symptom Cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20141130 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 55319-306_c51e3e5d-457e-434c-8312-e9d88eba8a29 55319-306 HUMAN OTC DRUG family wellness laxative Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20110621 ANDA ANDA090685 Family Dollar Services Inc POLYETHYLENE GLYCOL 3350 17 g/17g 55319-310_93f40701-7fff-4197-b9e6-7cfcd7641d03 55319-310 HUMAN OTC DRUG Cough Relief Orange DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20090701 OTC MONOGRAPH FINAL part341 Family Dollar DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 55319-311_d2686078-0096-445a-8589-4e283add6e96 55319-311 HUMAN OTC DRUG Peptic Relief Cherry Bismuth Subsalicylate SUSPENSION ORAL 20090729 OTC MONOGRAPH FINAL part335 Family Dollar BISMUTH SUBSALICYLATE 262 mg/15mL 55319-318_cc4a32d5-a154-4a14-bed8-75b1df9c8f0c 55319-318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 19910122 OTC MONOGRAPH NOT FINAL part356 Family Dollar Services, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL 55319-321_373e5512-0058-46dd-86e9-ce533e3f3a79 55319-321 HUMAN OTC DRUG family wellness acid controller complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20120802 ANDA ANDA077355 Family Dollar Services Inc CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 55319-322_49a4400b-85f1-43b1-ba90-8b5fdff6ec95 55319-322 HUMAN OTC DRUG Family Wellness Advanced Eye Dextran 70, Polyethylene Glycol 400, Povidone, and Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20140519 OTC MONOGRAPH FINAL part349 FAMILY DOLLAR DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL 55319-323_4118b0c9-fcc4-4438-bc66-176e250eba84 55319-323 HUMAN OTC DRUG FAMILY WELLNESS IRRITATION RELIEF AC EYE DROPS TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE SOLUTION OPHTHALMIC 20121031 OTC MONOGRAPH FINAL part349 FAMILY DOLLAR TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL 55319-326_fa066179-888e-4c03-9cb0-841acfc07f1e 55319-326 HUMAN OTC DRUG Laxative for Women Bisacodyl TABLET, COATED ORAL 20050212 OTC MONOGRAPH NOT FINAL part334 Family Dollar BISACODYL 5 mg/1 55319-329_8bab5d3f-4788-40a1-85a3-78c66fdd9c38 55319-329 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 Family Dollar DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55319-331_e25403cc-30dc-49d3-955b-fb968ab470fc 55319-331 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen LIQUID ORAL 20100209 OTC MONOGRAPH FINAL part341 Family Dollar ACETAMINOPHEN 160 mg/5mL 55319-333_bb2de374-8abf-4b0b-96c9-a05f15511ae7 55319-333 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Family Dollar Services, Inc. ACETAMINOPHEN 650 mg/1 55319-334_a958121f-3e37-4b83-af3f-467e815d9885 55319-334 HUMAN OTC DRUG Family Wellness Antifungal Clotrimazole CREAM TOPICAL 20140120 OTC MONOGRAPH FINAL part333C Family Dollar CLOTRIMAZOLE 10 mg/g 55319-337_9a2fd8f3-075f-466e-978d-94dc0b29fe88 55319-337 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141130 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL 55319-338_c95ebd0b-593e-48d9-9962-744623ff00a2 55319-338 HUMAN OTC DRUG Extra Strength Backache Relief Magnesium Salicylate Tetrahydrate CAPSULE ORAL 19981107 OTC MONOGRAPH NOT FINAL part343 Family Dollar MAGNESIUM SALICYLATE 580 mg/1 55319-339_17f1268e-1c58-461e-af51-25d5080a80e6 55319-339 HUMAN OTC DRUG Hydrocortisone Maximum Strength with Aloe Hydrocortisone CREAM TOPICAL 20070322 OTC MONOGRAPH NOT FINAL part348 Family Dollar Services Inc. HYDROCORTISONE 1 g/100g 55319-341_e565b88c-6218-400a-aef1-ed4fab23f886 55319-341 HUMAN OTC DRUG Day Time with PE Acetaminophen.Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20090630 OTC MONOGRAPH FINAL part341 Family Dollar ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 55319-348_ef9f0818-a2f0-4691-8db7-039a517f5fc3 55319-348 HUMAN OTC DRUG Maximum Strength Laxative Sennosides TABLET ORAL 20030104 OTC MONOGRAPH NOT FINAL part334 Family Dollar SENNOSIDES A AND B 25 mg/1 55319-351_bd2b1178-fb3b-4690-b7d0-a2622b91b2cb 55319-351 HUMAN OTC DRUG Regular Strength Acid Reducer Ranitidine TABLET ORAL 20110628 ANDA ANDA200536 Family Dollar RANITIDINE HYDROCHLORIDE 150 mg/1 55319-352_3cff4f08-e8e4-4324-a08b-9970c25665c4 55319-352 HUMAN OTC DRUG Regular Strength Acid Reducer Ranitidine TABLET ORAL 20130924 ANDA ANDA201745 Family Dollar RANITIDINE HYDROCHLORIDE 75 mg/1 55319-367_e92b39f4-3d3b-4926-8825-854faeaaccbd 55319-367 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 Family Dollar DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55319-368_31b82c90-7bc2-46f4-9521-04250b78d706 55319-368 HUMAN OTC DRUG Family Wellness Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 19970114 ANDA ANDA074661 Family Dollar Services Inc NAPROXEN SODIUM 220 mg/1 55319-374_7a331856-28b0-4ed0-9405-49d16d9f53bf 55319-374 HUMAN OTC DRUG Family Wellness Migraine Relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20130720 ANDA ANDA075794 Family Dollar Services Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 55319-375_76635567-82e4-435c-987e-83f77099e04b 55319-375 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 Family Dollar LOPERAMIDE HYDROCHLORIDE 2 mg/1 55319-376_376d44a7-dbe7-4a7a-9e44-8a9a45222c2c 55319-376 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140630 OTC MONOGRAPH NOT FINAL part356 Family Dollar (FAMILY WELLNESS) PHENOL 1.4 g/100mL 55319-377_7708816d-e2c6-4fda-87ff-19e0ad3927be 55319-377 HUMAN OTC DRUG Family Wellness Acid Reducer Famotidine TABLET ORAL 20130830 ANDA ANDA077351 Family Dollar Services Inc FAMOTIDINE 20 mg/1 55319-379_0370c6e5-528f-426e-83d8-f93369b23e39 55319-379 HUMAN OTC DRUG Childrens Nighttime Cold and Cough Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20140731 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 55319-390_29de75fe-17d2-401d-94f9-9a17029edc41 55319-390 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20140831 OTC MONOGRAPH FINAL part347 Family Dollar (FAMILY WELLNESS) WITCH HAZEL 842 mg/mL 55319-393_e3e3d47c-86c3-4f2d-8dc1-13ff8d92426e 55319-393 HUMAN OTC DRUG Ibuprofen IB Ibuprofen TABLET ORAL 20020408 ANDA ANDA075139 Family Dollar IBUPROFEN 200 mg/1 55319-400_f1a52339-96ea-4ecb-bf72-b34c1629170c 55319-400 HUMAN OTC DRUG Family wellness hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 20120309 OTC MONOGRAPH FINAL part346 Family Dollar Services Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 55319-403_1282530f-9106-4844-80a7-bf97caa93f57 55319-403 HUMAN OTC DRUG Less Drowsy Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 Family Dollar MECLIZINE HYDROCHLORIDE 25 mg/1 55319-404_cf21c50e-df4a-418e-acde-a817324b27fb 55319-404 HUMAN OTC DRUG EZ Nite Sleep Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140731 OTC MONOGRAPH FINAL part338 Family Dollar (FAMILY WELLNESS) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55319-411_44234fb8-3caa-470a-b418-2f9e93360f7b 55319-411 HUMAN OTC DRUG Cough and Cold HBP chlorpheniramine maleate and dextromethorphan hbr TABLET ORAL 20030503 OTC MONOGRAPH FINAL part341 Family Dollar CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 55319-440_9ff9a189-c768-4a98-bfc9-5a40dfa17f81 55319-440 HUMAN OTC DRUG Sore Throat Cherry Phenol LIQUID ORAL 20090801 OTC MONOGRAPH NOT FINAL part356 Family Dollar PHENOL 1.5 g/100mL 55319-450_6f1cb3cd-5018-4cd7-bf39-8c0ba9f101bf 55319-450 HUMAN OTC DRUG Junior Strength Acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Family Dollar ACETAMINOPHEN 160 mg/1 55319-453_1d2248f2-734c-46b8-89ff-2b6ba8d47de6 55319-453 HUMAN OTC DRUG Suphedrine PE Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 Family Dollar PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 55319-454_a19d011c-9ff7-4ef9-8c97-8d1d9239ac38 55319-454 HUMAN OTC DRUG FAMILY WELLNESS ANTIFUNGAL CLOTRIMAZOLE CREAM TOPICAL 20120401 OTC MONOGRAPH FINAL part333C FAMILY DOLLAR CLOTRIMAZOLE 1 g/100g 55319-455_6d2296b1-8d85-4ee0-8d76-24e8df83bb0b 55319-455 HUMAN OTC DRUG Allergy Multi-Symptom Acetaminophen, Chlorpheniramine Maleate and Phenylephrine HCl TABLET ORAL 20060530 OTC MONOGRAPH NOT FINAL part343 Family Dollar ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 55319-470_d20d68f3-d6c7-498b-b406-09102ae3dfd6 55319-470 HUMAN OTC DRUG Daytime Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130630 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 55319-471_04ae5912-27e9-4bf2-ab06-22a23db8502a 55319-471 HUMAN OTC DRUG Family Wellness Hydrocortisone hydrocortisone OINTMENT TOPICAL 20121205 OTC MONOGRAPH NOT FINAL part348 Family Dollar Services Inc HYDROCORTISONE 1 g/100g 55319-480_492204dc-f8ef-4d1b-994d-338a71302a73 55319-480 HUMAN OTC DRUG Nighttime Cold and Flu Relief Multi-Symptom Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130630 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 55319-484_f0147565-e557-4774-9e83-7f7b7139fa95 55319-484 HUMAN OTC DRUG family wellness acetaminophen Acetaminophen TABLET ORAL 19900615 OTC MONOGRAPH NOT FINAL part343 Family Dollar Services Inc ACETAMINOPHEN 500 mg/1 55319-490_b620b661-d7e0-4f11-bfec-efd1e852ec8c 55319-490 HUMAN OTC DRUG Daytime Nighttime Cold and Flu Relief Multi-Symptom Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130630 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) 55319-500_65c21404-f2c7-4f65-9bad-6b08107fce53 55319-500 HUMAN OTC DRUG Waterless Lavender Scented Hand Sanitizer ALCOHOL GEL TOPICAL 20110328 OTC MONOGRAPH FINAL part333E Family Dollar Services Inc. ALCOHOL 63 mL/100mL 55319-501_592786a5-6cc6-4a6a-9c33-f16e72f3a652 55319-501 HUMAN OTC DRUG Waterless Fragrance Free Hand Sanitizer ALCOHOL GEL TOPICAL 20110328 OTC MONOGRAPH FINAL part333E Family Dollar Services Inc. ALCOHOL 63 mL/100mL 55319-502_2d791fee-0635-4430-96d5-e0c1add591de 55319-502 HUMAN OTC DRUG Waterless Aloe Scented Hand Sanitizer ALCOHOL GEL TOPICAL 20110328 OTC MONOGRAPH FINAL part333E Family Dollar Services Inc. ALCOHOL 63 mL/100mL 55319-503_68a64a13-5d2b-46ea-8b31-5fb31d9b09b6 55319-503 HUMAN OTC DRUG Hand Sanitizer with Moisturizers and Vitamin E Alcohol GEL TOPICAL 20120831 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. ALCOHOL 70 mL/100mL 55319-504_f6a4de8d-ec61-4088-961a-962675b91c37 55319-504 HUMAN OTC DRUG Hand Sanitizer with Moisturizers and Vitamin E Alcohol LIQUID TOPICAL 20120831 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. ALCOHOL 70 mL/100mL 55319-505_9584a7b4-3551-4f12-a0c7-337bb1b6a9c9 55319-505 HUMAN OTC DRUG Hand Sanitizer with Moisturizers and Vitamin E Alcohol LIQUID TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. ALCOHOL 65 mL/100mL 55319-506_f039ce6a-de7e-4404-bf9b-ab94850d66c3 55319-506 HUMAN OTC DRUG Family Dollar Oil Free Acne Wash Salicylic Acid LIQUID TOPICAL 20140113 OTC MONOGRAPH FINAL part333D Family Dollar Services Inc. SALICYLIC ACID 2 g/100mL 55319-510_9edd241e-cb90-43fd-85ef-4612bc13aafa 55319-510 HUMAN OTC DRUG Family Dollar Instant Hand Sanitizer with Moisturizers and Vitamin E Alcohol GEL TOPICAL 20131023 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. ALCOHOL 70 mL/100mL 55319-512_586338d7-7c8a-4305-bca3-fd83b7c8374d 55319-512 HUMAN OTC DRUG Family Dollar Antibacterial Hand Triclosan SOAP TOPICAL 20140102 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. TRICLOSAN .15 g/100mL 55319-519_b3b829b3-e572-4af4-9081-8cd591d821a7 55319-519 HUMAN OTC DRUG Extra Strength Acetaminophen Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Family Dollar ACETAMINOPHEN 500 mg/1 55319-525_dfa4733a-9b6b-4fe8-bec2-96078cd01027 55319-525 HUMAN OTC DRUG Anti-Itch Extra Strength diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20091207 OTC MONOGRAPH NOT FINAL part348 Family Dollar Services Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; 1 mg/g; mg/g 55319-526_a6858dab-fe54-4a85-9321-4ea7d6e022c9 55319-526 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Family Dollar Services, Inc. LORATADINE 10 mg/1 55319-529_c4691e43-df45-4609-9158-aad9d778b4bd 55319-529 HUMAN OTC DRUG Multi-Symptom Cold Relief Acetaminophen, Chlorpehniramine HCl, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 Family Dollar 55319-531_aca1fd34-ea7f-420a-953e-c3c44b22c10a 55319-531 HUMAN OTC DRUG Extra Strength Acetaminophen Acetaminophen TABLET ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 Family Dollar ACETAMINOPHEN 500 mg/1 55319-532_28117b9f-74ee-496b-947d-ad698c1e27ea 55319-532 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20051222 OTC MONOGRAPH FINAL part341 Family Dollar GUAIFENESIN 400 mg/1 55319-533_26b2b44f-8e51-4cf8-a3c5-c9237d054b81 55319-533 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan HBr and Guiafenesin TABLET, FILM COATED ORAL 20051231 OTC MONOGRAPH FINAL part341 Family Dollar DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 55319-534_098a4e48-e106-4137-b067-15f0f5645efe 55319-534 HUMAN OTC DRUG Non-Drowsy Daytime Multi-Symptom Cold and Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20070919 OTC MONOGRAPH NOT FINAL part341 Family Dollar ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 55319-535_cba8ae4c-fbe2-47db-bfe5-43b0553c8dd8 55319-535 HUMAN OTC DRUG Nighttime Multi-Symptom Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20070910 OTC MONOGRAPH NOT FINAL part341 Family Dollar ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 55319-550_2fd0362a-507d-4f60-b96f-23001a2c5554 55319-550 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20130630 OTC MONOGRAPH FINAL part347 Family Dollar (FAMILY WELLNESS) DIMETHICONE 125 mg/1 55319-554_a475a511-e0ef-4fd3-a87a-f9d1fee81086 55319-554 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Family Dollar Services, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 55319-556_0a9b3593-a241-4480-af30-f90da07d08f5 55319-556 HUMAN OTC DRUG Extra Strength Acetaminophen PM Acetaminophen and Diphenhydramine HCl CAPSULE ORAL 20071217 OTC MONOGRAPH NOT FINAL part341 Family Dollar ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55319-596_f6be23e1-eec6-417c-a7ff-8fa829142524 55319-596 HUMAN OTC DRUG Childrens Chewable Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20110407 OTC MONOGRAPH FINAL part331 Family Dollar CALCIUM CARBONATE 400 mg/1 55319-600_1323f72e-5dfb-4a83-85fc-4bcf04b02c7a 55319-600 HUMAN OTC DRUG Enteric Coated Aspirin Aspirin TABLET ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 Family Dollar ASPIRIN 81 mg/1 55319-608_e08879d0-3247-44e0-bc9d-1004ff12e8f1 55319-608 HUMAN OTC DRUG Extra Strength Gas Relief Simethicone TABLET ORAL 20130701 OTC MONOGRAPH FINAL part332 Family Dollar DIMETHICONE 125 mg/1 55319-612_aa3f57ff-b89f-49f7-bc1e-21a280d047b8 55319-612 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20121218 OTC MONOGRAPH FINAL part358H Family Dollar Services, Inc. PYRITHIONE ZINC 1 g/mL 55319-616_94ebfdef-31d0-4ca9-b011-f3561a390c2d 55319-616 HUMAN OTC DRUG Maximum Strength Multi-Symptom Cold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET ORAL 20130407 OTC MONOGRAPH FINAL part341 Family Dollar ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 55319-619_80d97e06-8751-4ef2-a245-cb30b4af082d 55319-619 HUMAN OTC DRUG Regular Strength Acid Reducer Ranitidine TABLET ORAL 20130615 ANDA ANDA200536 Family Dollar RANITIDINE HYDROCHLORIDE 75 mg/1 55319-620_7af14e91-8f2d-4ae1-8364-d326b915f621 55319-620 HUMAN OTC DRUG Maximum Strength Acid Reducer Ranitidine TABLET ORAL 20130615 ANDA ANDA200536 Family Dollar RANITIDINE HYDROCHLORIDE 150 mg/1 55319-626_1185354e-5458-4ebc-93f2-1b6ac9032956 55319-626 HUMAN OTC DRUG Family Wellness Antifungal Clotrimazole CREAM TOPICAL 20140121 OTC MONOGRAPH FINAL part333C Family Dollar CLOTRIMAZOLE 10 mg/g 55319-638_8c202959-98aa-4c10-9bbf-f91215f59e5e 55319-638 HUMAN OTC DRUG Family Wellness Antifungal Tolnaftate CREAM TOPICAL 20140121 OTC MONOGRAPH FINAL part333C Family Dollar TOLNAFTATE 1 g/100g 55319-664_e325816c-652f-409a-8613-a2dd63a7b041 55319-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20110111 OTC MONOGRAPH NOT FINAL part356 Family Dollar EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 55319-678_fa842e0a-355f-46ec-9259-4fc6757bd7fd 55319-678 HUMAN OTC DRUG family wellness hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20121026 OTC MONOGRAPH FINAL part346 Family Dollar Services Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 55319-730_7db5dd09-a461-4454-b199-2e776b8604f9 55319-730 HUMAN OTC DRUG Miconazole 7 miconazole nitrate CREAM VAGINAL 20060606 ANDA ANDA074164 Family Dollar MICONAZOLE NITRATE 2 g/100g 55319-805_5626b091-de48-4fd9-8bc7-fa8a0c88a4ed 55319-805 HUMAN OTC DRUG Family Wellness Sterile Alcohol Isopropyl Alcohol SWAB TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc ISOPROPYL ALCOHOL 70 mL/100mL 55319-866_26a969c4-9ca7-4cff-9f64-fbd106e3a917 55319-866 HUMAN OTC DRUG family wellness lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20121205 OTC MONOGRAPH FINAL part358G Family Dollar Services Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 55319-871_bf09a405-921a-4f37-9190-fa467b44eb65 55319-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Family Dollar HYDROGEN PEROXIDE 30 mg/mL 55319-897_122bc3c8-9ab2-40c0-9eea-03b3789f20a1 55319-897 HUMAN OTC DRUG family wellness childrens ibuprofen Ibuprofen SUSPENSION ORAL 20020822 ANDA ANDA074937 Family Dollar Services Inc IBUPROFEN 100 mg/5mL 55319-900_f06fee99-2d1b-4adf-a5a0-9e90db64a461 55319-900 HUMAN OTC DRUG Family Wellness Sensitive Extra Whitening Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20130411 OTC MONOGRAPH NOT FINAL part356 Family Wellness POTASSIUM NITRATE; SODIUM FLUORIDE 5; 1.5 mg/g; mg/g 55319-915_0f195e96-4acb-48fa-b1f7-d6504601fe27 55319-915 HUMAN OTC DRUG Family Wellness Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20130814 NDA NDA022032 Family Dollar Services Inc OMEPRAZOLE 20 mg/1 55319-939_af27b405-1a09-4525-abb8-4b1b5f96bd1d 55319-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Family Dollar Services, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 55319-974_d346aa08-2ca8-4e0c-b4da-650734b364db 55319-974 HUMAN OTC DRUG family wellness childrens all day allergy cetirizine hydrochloride LIQUID ORAL 20120802 ANDA ANDA090254 Family Dollar Services Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 55319-999_1a14b6c0-47d8-41f9-9b1c-193685609145 55319-999 HUMAN OTC DRUG Multi-Symptom Menstrual Pain Relief Acetaminophen, Pamabrom and Pyrilamine maleate TABLET, FILM COATED ORAL 20000620 OTC MONOGRAPH NOT FINAL part343 Family Dollar ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 55322-0001_afa9f1e2-c643-4ac6-bfbf-8384798c512c 55322-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850601 UNAPPROVED MEDICAL GAS Diamond Drugs Inc. dba Diamond Medical Supply OXYGEN 99 L/100L 55328-900_e33f4418-bf2e-47b9-835e-8bbe25fe2744 55328-900 HUMAN OTC DRUG Salonpas DEEP Relieving Camphor, Menthol, Methyl salicylate GEL PERCUTANEOUS; TOPICAL; TRANSDERMAL 20130601 OTC MONOGRAPH NOT FINAL part348 Hisamitsu America, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3.1; 10; 15 g/100g; g/100g; g/100g 55330-0001_fb693684-a6b5-4cad-a0cf-1aff2ea08bbe 55330-0001 HUMAN OTC DRUG Wholistic Thyroid Balance Fucus, Vesiculosus, Thyroidinum (Suis), Spongia Tosta LIQUID ORAL 20130820 UNAPPROVED HOMEOPATHIC Institute for Wholistic Rejuvenation FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID 3; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55346-0401_f31dc5dc-5137-43b7-8317-62858b1ecf7f 55346-0401 HUMAN OTC DRUG Home Care Fluoride Stannous Fluoride GEL DENTAL; ORAL 19991231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g 55346-0402_6ab54113-6892-4c40-9007-5ad8a5526d6f 55346-0402 HUMAN OTC DRUG Alpha-dent Home Care Fluoride Stannous Fluoride GEL DENTAL; ORAL 19991231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g 55346-0404_23444fe2-b484-4820-a079-480a408e4c36 55346-0404 HUMAN OTC DRUG Home Care Fluoride Stannous Fluoride GEL DENTAL; ORAL 19991231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g 55346-0408_5f59bc38-b397-44d9-8135-e7155ad5b388 55346-0408 HUMAN OTC DRUG Home Care Fluoride Stannous Fluoride GEL DENTAL; ORAL 19991231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g 55346-0411_b57645a8-1e00-4820-af3d-3472d93559ae 55346-0411 HUMAN OTC DRUG Plak Smacker Stannous Fluoride GEL DENTAL; ORAL 20071231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g 55346-0412_4ea3510f-2862-446b-8a7d-222dfb903a47 55346-0412 HUMAN OTC DRUG Plak Smacker Stannous Fluoride GEL DENTAL; ORAL 20071231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g 55346-0414_f1934dd0-a0c7-4ce2-8bd0-2e38644f29b9 55346-0414 HUMAN OTC DRUG Plak Smacker Stannous Fluoride GEL DENTAL; ORAL 20071231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g 55346-0418_cde2fd36-5c63-4cfa-9517-7e347ec91727 55346-0418 HUMAN OTC DRUG Plak Smacker Stannous Fluoride GEL DENTAL; ORAL 20071231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g 55346-0431_81bc6d57-79cc-4a27-ac63-3675113eded0 55346-0431 HUMAN OTC DRUG Plak Smacker Stannous Fluoride GEL DENTAL; ORAL 20071231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g 55346-0718_d7e8c3f7-eb2a-448c-af0e-a8c275c3fbf4 55346-0718 HUMAN OTC DRUG Plak Smacker Sodium Fluoride PASTE, DENTIFRICE DENTAL; ORAL 20071231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc SODIUM FLUORIDE 2.4 mg/g 55346-0719_ca1618ef-fecd-44d0-8610-acc671d31232 55346-0719 HUMAN OTC DRUG Plak Smacker Sodium Fluoride PASTE, DENTIFRICE DENTAL; ORAL 20071231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc SODIUM FLUORIDE .4 mg/g 55346-0942_5b7fbec6-ecf3-49e1-97b1-0c2c71488fcf 55346-0942 HUMAN PRESCRIPTION DRUG Alpha-Pro Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20130401 UNAPPROVED DRUG OTHER Dental Technologies, Inc. HYDROFLUORIC ACID; SODIUM FLUORIDE 4.4; 7.9 mg/g; mg/g 55346-0943_18f227f2-7934-4b6e-8718-790908117940 55346-0943 HUMAN PRESCRIPTION DRUG Alpha-Pro Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20130401 UNAPPROVED DRUG OTHER Dental Technologies, Inc. HYDROFLUORIC ACID; SODIUM FLUORIDE 4.4; 7.9 mg/g; mg/g 55346-1401_74537324-55c2-4912-94ab-a345658f7aa5 55346-1401 HUMAN OTC DRUG Comfortcaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Dental Technologies, Inc. BENZOCAINE 200 mg/g 55346-1402_3a29ef01-a52f-4298-9e37-bc3b7c7f3a63 55346-1402 HUMAN OTC DRUG ComfortCaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Dental Technologies, Inc. BENZOCAINE 200 mg/g 55346-1403_b56810f2-801b-4f93-94a3-976cfb94be44 55346-1403 HUMAN OTC DRUG ComfortCaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Dental Technologies, Inc. BENZOCAINE 200 mg/g 55346-1404_24d87084-a853-4fe3-88ff-a1777276bd46 55346-1404 HUMAN OTC DRUG Comfortcaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Dental Technologies, Inc. BENZOCAINE 200 mg/g 55346-1405_0b2689c1-a87e-4d25-aeed-db81a539fd6e 55346-1405 HUMAN OTC DRUG ComfortCaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Dental Technologies, Inc. BENZOCAINE 200 mg/g 55346-1406_9594ff9b-78e3-4dd0-b8d2-204be31e63a0 55346-1406 HUMAN OTC DRUG Comfortcaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Dental Technologies, Inc. BENZOCAINE 200 mg/g 55346-2901_666b915b-fdd0-4669-a7c7-164b8542e26e 55346-2901 HUMAN OTC DRUG Alpha-Caine Topical Anesthetic Benzocaine GEL TOPICAL 19991231 OTC MONOGRAPH NOT FINAL part356 Dental Technologies, Inc. BENZOCAINE 200 mg/g 55346-2902_d3dd51d5-7aef-4679-9e97-8daaf218ed5e 55346-2902 HUMAN OTC DRUG Alpha-Caine Topical Anesthetic Benzocaine GEL TOPICAL 19991231 OTC MONOGRAPH NOT FINAL part356 Dental Technologies, Inc. BENZOCAINE 200 mg/g 55346-2903_a379dc11-8602-4352-b33c-e253d5affc55 55346-2903 HUMAN OTC DRUG Alpha-Caine Topical Anesthetic Benzocaine GEL TOPICAL 19991231 OTC MONOGRAPH NOT FINAL part356 Dental Technologies, Inc. BENZOCAINE 200 mg/g 55346-2904_617dff7a-d0d1-48e3-b8a6-db77334235f3 55346-2904 HUMAN OTC DRUG Alpha-Caine Topical Anesthetic Benzocaine GEL TOPICAL 19991231 OTC MONOGRAPH NOT FINAL part356 Dental Technologies, Inc. BENZOCAINE 200 mg/g 55379-404_ac502553-75ab-458f-8130-9b6013c2004c 55379-404 HUMAN OTC DRUG Joint and Muscle Pain Menthol CREAM TOPICAL 20090715 OTC MONOGRAPH NOT FINAL part348 BioZone Laboratories, Inc. MENTHOL 50 mg/g 55379-405_4e2e9bc4-6ba8-11e0-ae3e-0800200c9a66 55379-405 HUMAN PRESCRIPTION DRUG Hybrisil Methylprednisolone Acetate GEL TOPICAL 20100505 UNAPPROVED DRUG OTHER BioZone Laboratories, Inc. METHYLPREDNISOLONE ACETATE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 55379-406_008a5dc6-136b-4809-bec6-0a7ecf1f3981 55379-406 HUMAN OTC DRUG CortiSil MDX HYDROCORTISONE ACETATE GEL TOPICAL 20130325 OTC MONOGRAPH FINAL part348 BioZone Laboratories,Inc. HYDROCORTISONE ACETATE 1 g/100g 55379-407_f050e1de-72f4-41b2-b8c7-c6e3caf441da 55379-407 HUMAN OTC DRUG A AND A Diaper Rash cream DIMETHICONE and ZINC OXIDE CREAM TOPICAL 20130615 OTC MONOGRAPH FINAL part347 BioZone Laboratories, Inc. DIMETHICONE; ZINC OXIDE 10; 100 mg/g; mg/g 55390-004_51f646a9-97e5-494f-bd57-7004ba062374 55390-004 HUMAN PRESCRIPTION DRUG GlucaGen glucagon hydrochloride KIT 20050622 NDA NDA020918 Bedford Laboratories 55390-007_673a4086-d601-415f-939b-fc9cc6097dd8 55390-007 HUMAN PRESCRIPTION DRUG Valproate Sodium Valproate Sodium INJECTION INTRAVENOUS 20021114 20150228 ANDA ANDA076295 Bedford Laboratories VALPROATE SODIUM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55390-012_60f2dfa9-4e4a-402b-99bf-f576e5d4516d 55390-012 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION, SOLUTION INTRAVENOUS 20040729 20150228 ANDA ANDA076087 Bedford Laboratories FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55390-021_5c54b52d-741f-47f2-b029-4f33e6d8f3b9 55390-021 HUMAN PRESCRIPTION DRUG Milrinone Lactate Milrinone Lactate INJECTION INTRAVENOUS 20020527 20150531 ANDA ANDA075660 Bedford Laboratories MILRINONE LACTATE 1 mg/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 55390-046_60f2dfa9-4e4a-402b-99bf-f576e5d4516d 55390-046 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION, SOLUTION INTRAVENOUS 20040729 20150228 ANDA ANDA076087 Bedford Laboratories FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55390-054_ae894a0c-603d-4f75-b5e1-b12e2f9c67c2 55390-054 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000608 20150228 ANDA ANDA040335 Bedford Laboratories LEUCOVORIN CALCIUM 350 mg/17.5mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 55390-073_d25ec71d-74e0-49ee-b694-61dffcd87e58 55390-073 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 20030717 20150331 ANDA ANDA076495 Bedford Laboratories METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55390-077_1fb309f9-6246-48d8-b66b-32896d79dca0 55390-077 HUMAN PRESCRIPTION DRUG Prochlorperazine Edisylate Prochlorperazine Edisylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20040726 20150331 ANDA ANDA040540 Bedford Laboratories PROCHLORPERAZINE EDISYLATE 5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 55390-113_5122b623-960f-428b-910b-3c396baf2ccf 55390-113 HUMAN PRESCRIPTION DRUG Phentolamine Mesylate Phentolamine Mesylate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19980515 20150930 ANDA ANDA040235 Bedford Laboratories PHENTOLAMINE MESYLATE 5 mg/mL Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55390-123_16131af8-0941-4d77-95c8-194366155072 55390-123 HUMAN PRESCRIPTION DRUG Rifampin Rifampin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20020218 20150731 ANDA ANDA064217 Bedford Laboratories RIFAMPIN 600 mg/10mL Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 55390-136_b477ddd2-5e5f-44a5-be50-d63165045e20 55390-136 HUMAN PRESCRIPTION DRUG Levocarnitine Levocarnitine INJECTION INTRAVENOUS 20010423 20150331 ANDA ANDA075567 Bedford Laboratories LEVOCARNITINE 1 g/5mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] 55390-162_150fe58f-d869-4909-bd18-28a41d4164aa 55390-162 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20050404 20150331 ANDA ANDA076313 Bedford Laboratories OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 55390-194_60f2dfa9-4e4a-402b-99bf-f576e5d4516d 55390-194 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION, SOLUTION INTRAVENOUS 20100114 20150228 ANDA ANDA076087 Bedford Laboratories FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 55390-226_6b358628-c450-436a-84f0-f77702ef476c 55390-226 HUMAN PRESCRIPTION DRUG Amikacin Sulfate Amikacin Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19940531 20150630 ANDA ANDA063315 Bedford Laboratories AMIKACIN SULFATE 250 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 55390-308_19c0c1e9-0c72-4913-927c-aaa173c3421e 55390-308 HUMAN PRESCRIPTION DRUG amifostine amifostine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080402 NDA NDA020221 Bedford Laboratories AMIFOSTINE 500 mg/10mL Cytoprotective Agent [EPC],Free Radical Scavenging Activity [MoA] 55390-357_be5e4f4b-51a8-40e5-989f-5655667d9bbd 55390-357 HUMAN PRESCRIPTION DRUG CAFCIT caffeine citrate INJECTION INTRAVENOUS 20081104 20160430 NDA NDA020793 Bedford Laboratories CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 55390-358_be5e4f4b-51a8-40e5-989f-5655667d9bbd 55390-358 HUMAN PRESCRIPTION DRUG CAFCIT caffeine citrate SOLUTION ORAL 20081104 20160529 NDA NDA020793 Bedford Laboratories CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 55390-370_57820857-4427-9067-a130-4e1a6ca3e637 55390-370 HUMAN PRESCRIPTION DRUG Topotecan Hydrochloride Topotecan Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110418 ANDA ANDA201191 Bedford Laboratories TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 55390-391_4cef5f77-82b5-ba03-1f26-4fdeb8af63fd 55390-391 HUMAN PRESCRIPTION DRUG gemcitabine gemcitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120319 ANDA ANDA091365 Bedford Laboratories GEMCITABINE HYDROCHLORIDE 40 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 55390-565_78bc8784-673d-4674-9a0f-9de775966156 55390-565 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19960228 20150430 ANDA ANDA074617 Bedford Laboratories DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 55390-613_4e677f4b-0520-4874-ba0d-72479918d782 55390-613 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19970423 20150130 ANDA ANDA074596 Bedford Laboratories ACYCLOVIR SODIUM 1000 mg/20mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55404-001_e394174f-9db1-40e3-8bd0-90fce50817a4 55404-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19640101 UNAPPROVED MEDICAL GAS Lessors, Incorporated OXYGEN 995 mL/L 55404-002_5684b742-340c-450d-996f-093f49467488 55404-002 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19640101 UNAPPROVED MEDICAL GAS Lessors, Incorporated NITROUS OXIDE 990 mL/L 55413-2500_a24246b3-9b69-4969-b06c-7068623d7c1f 55413-2500 HUMAN OTC DRUG Raw Ice menthol LIQUID TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part348 Raw Health International, LLC MENTHOL 34.79 g/L 55413-2501_d851dba4-b008-4343-a4ea-66dd8a981177 55413-2501 HUMAN OTC DRUG Raw Heat menthol LIQUID TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part348 Raw Health International, LLC MENTHOL 34.86 g/L 55424-1238_149068a8-1b23-4530-8a0f-a65f98ad5da5 55424-1238 HUMAN OTC DRUG Nan San MUSFLEX External Analgesic CAMPHOR (NATURAL), MENTHOL LOTION TOPICAL 20130109 OTC MONOGRAPH FINAL part348 CHUNG KEE USA INTERNATIONAL INC CAMPHOR (NATURAL); MENTHOL 60; 160 mg/mL; mg/mL 55424-1398_191734b3-f360-4e02-9211-52c127c94788 55424-1398 HUMAN OTC DRUG Pain Relieving MUSFLEX CAMPHOR (NATURAL), MENTHOL LOTION TOPICAL 20130109 OTC MONOGRAPH FINAL part348 CHUNG KEE USA INTERNATIONAL INC CAMPHOR (NATURAL); MENTHOL 56; 56 mg/mL; mg/mL 55429-0838_f11d9187-e135-468f-b8f1-0bb7d32536b1 55429-0838 HUMAN OTC DRUG Nan San EASY FLEX Pain Relieving MENTHOL LOTION TOPICAL 20140611 OTC MONOGRAPH NOT FINAL part348 Herba Enterprise Inc MENTHOL 60 mg/mL 55439-000_674d70e4-8be1-4f0f-bc01-4a41b8e36dde 55439-000 HUMAN OTC DRUG Royal Hand Sanitizer ALCOHOL GEL TOPICAL 20130107 OTC MONOGRAPH NOT FINAL part333E GPM Investments LLC ALCOHOL 620 mg/mL 55441-201_51589658-3df8-4235-85cd-f05e16a83a9d 55441-201 HUMAN OTC DRUG Medi-Clean Antiseptic Hand Cleaner CHLOROXYLENOL LIQUID TOPICAL 20120213 OTC MONOGRAPH NOT FINAL part333E Formula Corp. CHLOROXYLENOL .6 mL/100mL 55441-901_ebe14342-2397-431f-b79f-6680b7038d71 55441-901 HUMAN OTC DRUG ecologique PYRITHIONE ZINC SHAMPOO TOPICAL 20120213 OTC MONOGRAPH FINAL part358H Formula Corp. PYRITHIONE ZINC 1 mL/100mL 55443-0085_0f3d5deb-cd79-499f-93aa-9fe990277a79 55443-0085 HUMAN OTC DRUG VioNex Chloroxylenol GEL TOPICAL 19920101 OTC MONOGRAPH NOT FINAL part333 Metrex Research CHLOROXYLENOL .52 g/100mL 55443-0090_8700e691-f8e2-4026-9d75-83eaaa378577 55443-0090 HUMAN OTC DRUG VioNex Chloroxylenol GEL TOPICAL 19920101 OTC MONOGRAPH NOT FINAL part333E Metrex Research CHLOROXYLENOL .52 g/100mL 55443-0102_0c1487f9-c0e0-47ae-8969-282107b9a655 55443-0102 HUMAN OTC DRUG VioNex Towelette Chloroxylenol CLOTH TOPICAL 19920101 OTC MONOGRAPH NOT FINAL part333 Metrex Research CHLOROXYLENOL .5 g/100g 55443-0200_2cdc122a-fe7b-4c0d-9ee7-dc38b25f6800 55443-0200 HUMAN OTC DRUG VioNexus Chloroxylenol LIQUID TOPICAL 19920101 OTC MONOGRAPH NOT FINAL part333E Metrex Research BENZALKONIUM CHLORIDE; ETHANOL .085; 77.01 g/100mL; g/100mL 55465-001_39c34e36-fb4c-464b-9c23-2e3e777fa064 55465-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Ivey Industries Inc. OXYGEN 990 mL/L 55465-002_71bf7684-affd-4a9b-8017-8c0a039b0007 55465-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19860801 UNAPPROVED MEDICAL GAS Ivey Industries NITROGEN 990 mL/L 55494-100_fe18a6fd-e343-45c6-ae57-76ea1d649259 55494-100 HUMAN PRESCRIPTION DRUG DICLEGIS doxylamine succinate and pyridoxine hydrochloride TABLET, DELAYED RELEASE ORAL 20130515 NDA NDA021876 Duchesnay USA, Inc. DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE 10; 10 mg/1; mg/1 55496-1001_d7961105-2315-4c0c-af10-02dd7e022ed8 55496-1001 HUMAN OTC DRUG Park no suk a clear walk of park ANGELICA ARCHANGELICA ROOT CREAM ORAL 20130216 UNAPPROVED DRUG OTHER Park No Suk a clear walk of park ANGELICA ARCHANGELICA ROOT 5 g/100g 55502-1001_ae69f978-baed-4a37-b6aa-3eb54ce07dd0 55502-1001 HUMAN OTC DRUG B.S.C AMPUL ADENOSINE LIQUID TOPICAL 20130130 UNAPPROVED DRUG OTHER Cellcos Inc ADENOSINE .6 mg/6mL 55504-0050_0cba4b30-9d7c-4a4f-8756-3dbb9cf932ec 55504-0050 HUMAN OTC DRUG DawnMist Deodorant Bar No. 1/2 TRICLOSAN SOAP TOPICAL 20100415 OTC MONOGRAPH FINAL part333 Donovan Industries, Inc TRICLOSAN 25 g/100g 55504-0075_a12cf025-7716-457b-97b8-4507d2885af8 55504-0075 HUMAN OTC DRUG DawnMist Deodorant Bar No. 3/4 TRICLOSAN SOAP TOPICAL 20100414 OTC MONOGRAPH FINAL part333 Donovan Industries, Inc TRICLOSAN 25 g/100g 55504-0100_7b35838b-123b-4ebc-86c8-2d94a9386177 55504-0100 HUMAN OTC DRUG DawnMist Deodorant Bar Soap No. 1 TRICLOSAN SOAP TOPICAL 20100602 OTC MONOGRAPH FINAL part333 Donovan Industries, Inc TRICLOSAN 25 g/100g 55504-0112_dc9ceac6-697d-40b8-8c0b-bf8f730a95c1 55504-0112 HUMAN OTC DRUG DawnMist Deodorant Bar No. 1 1/2 TRICLOSAN SOAP TOPICAL 20100415 OTC MONOGRAPH FINAL part333 Donovan Industries, Inc TRICLOSAN 25 g/100g 55504-0230_bba1749c-895b-4bea-8103-7a5c0dcc2296 55504-0230 HUMAN OTC DRUG DawnMist Antiperspirant and Deodorant ALUMINUM CHLOROHYDRATE SPRAY TOPICAL 20111005 OTC MONOGRAPH FINAL part350 Donovan Industries, Inc. ALUMINUM CHLOROHYDRATE 7.9 mL/100mL 55504-0300_1904187e-cba7-44d7-8905-3b1e375b5e0f 55504-0300 HUMAN OTC DRUG DawnMist Deodorant Bar No. 3 TRICLOSAN SOAP TOPICAL 20100602 OTC MONOGRAPH FINAL part333 Donovan Industries, Inc TRICLOSAN 25 g/100g 55504-0432_cd42069d-01be-4b52-90ae-0ad7a7fd0b30 55504-0432 HUMAN OTC DRUG DawnMist Hypoallergenic Petroleum PETROLATUM JELLY TOPICAL 20110927 OTC MONOGRAPH FINAL part347 Donovan Industries, Inc. PETROLATUM 100 g/100g 55504-0500_40f202a9-501e-4a2b-aaed-98dbb99ffc85 55504-0500 HUMAN OTC DRUG DawnMist Deodorant Bar No. 5 TRICLOSAN SOAP TOPICAL 20100414 OTC MONOGRAPH FINAL part333 Donovan Industries, Inc TRICLOSAN 25 g/100g 55504-0540_60f08b51-e2cd-4939-9acb-401fd3a718ac 55504-0540 HUMAN OTC DRUG DawnMist Toothbrush, Toothpaste and Floss Kit PASTE DENTAL 20090901 OTC MONOGRAPH FINAL part355 Donovan Industries, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/3g 55504-3736_8b9abe45-9eb5-4888-bfb5-a584fe92af24 55504-3736 HUMAN OTC DRUG DawnMist Alcohol Gel Hand Sanitizer ALCOHOL GEL TOPICAL 20091106 OTC MONOGRAPH NOT FINAL part333 Donovan Industries, Inc. ALCOHOL 62 mL/100mL 55504-3763_3b068719-aa3f-49ff-b858-e8d6a957d217 55504-3763 HUMAN OTC DRUG DawnMist Alcohol Gel Hand Sanitizer ALCOHOL GEL TOPICAL 20091106 OTC MONOGRAPH NOT FINAL part333 Donovan Industries, Inc. ALCOHOL 62 mL/100mL 55504-4000_f901a748-4ab5-4aee-a87c-baf5b6f8c219 55504-4000 HUMAN OTC DRUG MediChoice Hand Sanitizer ALCOHOL GEL TOPICAL 20091231 OTC MONOGRAPH NOT FINAL part333 Donovan Industries, Inc. ALCOHOL 62 mL/100mL 55504-4341_87b9b288-0dd8-4b02-90b2-bb09ab8838c6 55504-4341 HUMAN OTC DRUG dawnmist sodium fluoride PASTE DENTAL 20111101 OTC MONOGRAPH FINAL part355 Donavan SODIUM FLUORIDE 39.9 g/181.4g 55504-9001_7334aee0-578b-4fde-845c-d66aabb5dbfa 55504-9001 HUMAN OTC DRUG DawnMist Clean Fresh Scent Roll-On Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20101001 OTC MONOGRAPH FINAL part350 Donovan Industries, Inc. ALUMINUM CHLOROHYDRATE 7.8 mL/100mL 55504-9002_2dcd6dc8-dd85-4b6f-b0e2-d5ebdb70574e 55504-9002 HUMAN OTC DRUG DawnMist Unscented Roll-On Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20101001 OTC MONOGRAPH FINAL part350 Donovan Industries, Inc. ALUMINUM CHLOROHYDRATE 7.8 mL/100mL 55504-9003_3dead2ee-b4b9-4e9c-a259-a8e1dad39cbc 55504-9003 HUMAN OTC DRUG DawnMist Clean Fresh Scent Roll-On Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20101001 OTC MONOGRAPH FINAL part350 Donovan Industries, Inc. ALUMINUM CHLOROHYDRATE 7.8 mL/100mL 55505-103_af99b691-3713-44c1-ab7d-bd918ae3b4c3 55505-103 HUMAN OTC DRUG Fungi Nail Toe and Foot Undecylenic acid LIQUID TOPICAL 20101207 OTC MONOGRAPH FINAL part333C Kramer Laboratories UNDECYLENIC ACID 250 mg/mL 55505-111_cabb6a94-5572-4808-a431-b4e1f4d3d69d 55505-111 HUMAN OTC DRUG Safetussin DM Dextromethorpan Guaifenesin LIQUID ORAL 20101129 OTC MONOGRAPH FINAL part341 Kramer Laboratories DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 55505-146_10d42d77-1722-4a41-ae88-e1b7b21b0004 55505-146 HUMAN OTC DRUG Hongo Cura RS Zinc Undecylenate Undecylenic acid CREAM TOPICAL 20101214 OTC MONOGRAPH FINAL part333C Kramer Laboratories UNDECYLENIC ACID; ZINC UNDECYLENATE 5; 20 g/100g; g/100g 55505-154_9d720f3a-e226-43cc-a51c-350e302141ce 55505-154 HUMAN OTC DRUG Hongo Cura MS Undecylenic acid SPRAY TOPICAL 20101214 OTC MONOGRAPH FINAL part333C Kramer Laboratories UNDECYLENIC ACID 250 mg/mL 55505-167_c3180fd9-8758-47c3-aa2d-3b455200359c 55505-167 HUMAN OTC DRUG Fungi Nail Toe and Foot Pen Undecylenic acid LIQUID TOPICAL 20101205 OTC MONOGRAPH FINAL part333C Kramer Laboratories UNDECYLENIC ACID 250 mg/mL 55505-173_8e6df8ba-581a-4220-b556-18acbe485fe3 55505-173 HUMAN OTC DRUG Safetussin PM Dextromethorphan Doxylamine Succinate LIQUID ORAL 20101201 OTC MONOGRAPH NOT FINAL part341 Kramer Laboratories DEXTROMETHORPHAN; DOXYLAMINE SUCCINATE 7.5; 3.125 mg/5mL; mg/5mL 55505-174_f0b1d568-ab29-47fe-8698-3749ed4776bd 55505-174 HUMAN OTC DRUG Fungi Nail Toe and Foot MS Zinc Undecylenate Undecylenic acid OINTMENT TOPICAL 20120301 OTC MONOGRAPH FINAL part333C Kramer Laboratories UNDECYLENIC ACID; ZINC UNDECYLENATE 5; 20 g/20g; g/20g 55513-002_21d8e10c-945f-44e8-87c4-4a0882351273 55513-002 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060911 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 25 ug/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-003_21d8e10c-945f-44e8-87c4-4a0882351273 55513-003 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060911 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 40 ug/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-004_21d8e10c-945f-44e8-87c4-4a0882351273 55513-004 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060911 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 60 ug/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-005_21d8e10c-945f-44e8-87c4-4a0882351273 55513-005 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060911 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 100 ug/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-006_21d8e10c-945f-44e8-87c4-4a0882351273 55513-006 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060911 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 200 ug/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-021_21d8e10c-945f-44e8-87c4-4a0882351273 55513-021 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060814 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 40 ug/.4mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-023_21d8e10c-945f-44e8-87c4-4a0882351273 55513-023 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060814 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 60 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-025_21d8e10c-945f-44e8-87c4-4a0882351273 55513-025 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060814 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 100 ug/.5mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-027_21d8e10c-945f-44e8-87c4-4a0882351273 55513-027 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060911 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 150 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-028_21d8e10c-945f-44e8-87c4-4a0882351273 55513-028 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060814 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 200 ug/.4mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-032_21d8e10c-945f-44e8-87c4-4a0882351273 55513-032 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060607 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 500 ug/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-053_21d8e10c-945f-44e8-87c4-4a0882351273 55513-053 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060911 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 150 ug/.75mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-057_21d8e10c-945f-44e8-87c4-4a0882351273 55513-057 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060826 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 25 ug/.42mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-073_d51dc4c9-3f79-4c3a-b598-cf038d737103 55513-073 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20040404 NDA NDA021688 Amgen Inc CINACALCET HYDROCHLORIDE 30 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] 55513-074_d51dc4c9-3f79-4c3a-b598-cf038d737103 55513-074 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20040404 NDA NDA021688 Amgen Inc CINACALCET HYDROCHLORIDE 60 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] 55513-075_d51dc4c9-3f79-4c3a-b598-cf038d737103 55513-075 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20040404 NDA NDA021688 Amgen Inc CINACALCET HYDROCHLORIDE 90 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] 55513-110_21d8e10c-945f-44e8-87c4-4a0882351273 55513-110 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060814 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 300 ug/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-111_21d8e10c-945f-44e8-87c4-4a0882351273 55513-111 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060814 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 300 ug/.6mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-126_89a8e8ee-9d7a-422f-9271-6563fabf6f69 55513-126 HUMAN PRESCRIPTION DRUG EPOGEN epoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 19890630 BLA BLA103234 Amgen Inc ERYTHROPOIETIN 2000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-144_89a8e8ee-9d7a-422f-9271-6563fabf6f69 55513-144 HUMAN PRESCRIPTION DRUG EPOGEN epoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 19930816 BLA BLA103234 Amgen Inc ERYTHROPOIETIN 10000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-148_89a8e8ee-9d7a-422f-9271-6563fabf6f69 55513-148 HUMAN PRESCRIPTION DRUG EPOGEN epoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 19930816 BLA BLA103234 Amgen Inc ERYTHROPOIETIN 4000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-160_a5ddc10c-a1fb-4a07-aebc-5344f0b7b34d 55513-160 HUMAN PRESCRIPTION DRUG BLINCYTO blinatumomab KIT INTRAVENOUS 20141218 BLA BLA125557 Amgen Inc 55513-190_777a44b9-d695-4679-8e40-50b791d89fe2 55513-190 HUMAN PRESCRIPTION DRUG Neulasta pegfilgrastim INJECTION SUBCUTANEOUS 20020401 BLA BLA125031 Amgen Inc PEGFILGRASTIM 6 mg/.6mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] 55513-209_d95bd786-9c42-4c22-9f14-6a50ff1a2080 55513-209 HUMAN PRESCRIPTION DRUG NEUPOGEN Filgrastim INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20001002 BLA BLA103353 Amgen Inc FILGRASTIM 480 ug/.8mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] 55513-221_1a708aca-8b0c-4cd9-9f30-76501636d609 55513-221 HUMAN PRESCRIPTION DRUG Nplate romiplostim INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20080825 BLA BLA125268 Amgen Inc ROMIPLOSTIM 250 ug/.5mL Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoiesis Stimulating Agent [EPC],Thrombopoietin Receptor Agonists [MoA],Thrombopoietin Receptor Interactions [MoA] 55513-222_1a708aca-8b0c-4cd9-9f30-76501636d609 55513-222 HUMAN PRESCRIPTION DRUG Nplate romiplostim INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20080825 BLA BLA125268 Amgen Inc ROMIPLOSTIM 500 ug/mL Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoiesis Stimulating Agent [EPC],Thrombopoietin Receptor Agonists [MoA],Thrombopoietin Receptor Interactions [MoA] 55513-267_89a8e8ee-9d7a-422f-9271-6563fabf6f69 55513-267 HUMAN PRESCRIPTION DRUG EPOGEN epoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 19900430 BLA BLA103234 Amgen Inc ERYTHROPOIETIN 3000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-283_89a8e8ee-9d7a-422f-9271-6563fabf6f69 55513-283 HUMAN PRESCRIPTION DRUG EPOGEN epoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 19941205 BLA BLA103234 Amgen Inc ERYTHROPOIETIN 10000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-478_89a8e8ee-9d7a-422f-9271-6563fabf6f69 55513-478 HUMAN PRESCRIPTION DRUG EPOGEN epoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 19970303 BLA BLA103234 Amgen Inc ERYTHROPOIETIN 20000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 55513-530_d95bd786-9c42-4c22-9f14-6a50ff1a2080 55513-530 HUMAN PRESCRIPTION DRUG NEUPOGEN Filgrastim INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19970519 BLA BLA103353 Amgen Inc FILGRASTIM 300 ug/mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] 55513-546_d95bd786-9c42-4c22-9f14-6a50ff1a2080 55513-546 HUMAN PRESCRIPTION DRUG NEUPOGEN Filgrastim INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19970407 BLA BLA103353 Amgen Inc FILGRASTIM 480 ug/1.6mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] 55513-710_f23bd1e9-1b2a-42ed-b6a9-2198cff4f659 55513-710 HUMAN PRESCRIPTION DRUG Prolia denosumab INJECTION SUBCUTANEOUS 20100605 BLA BLA125320 Amgen Inc DENOSUMAB 60 mg/mL RANK Ligand Inhibitor [EPC],RANK Ligand Blocking Activity [MoA] 55513-730_a7793a46-924e-4995-83b2-7a277a467013 55513-730 HUMAN PRESCRIPTION DRUG XGEVA denosumab INJECTION SUBCUTANEOUS 20101118 BLA BLA125320 Amgen Inc DENOSUMAB 120 mg/1.7mL RANK Ligand Inhibitor [EPC],RANK Ligand Blocking Activity [MoA] 55513-924_d95bd786-9c42-4c22-9f14-6a50ff1a2080 55513-924 HUMAN PRESCRIPTION DRUG NEUPOGEN Filgrastim INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20001002 BLA BLA103353 Amgen Inc FILGRASTIM 300 ug/.5mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] 55513-954_707e93ca-2021-4591-b90d-717ee74c8335 55513-954 HUMAN PRESCRIPTION DRUG Vectibix panitumumab SOLUTION INTRAVENOUS 20061010 BLA BLA125147 Amgen Inc PANITUMUMAB 100 mg/5mL Epidermal Growth Factor Receptor Antagonist [EPC] 55513-955_707e93ca-2021-4591-b90d-717ee74c8335 55513-955 HUMAN PRESCRIPTION DRUG Vectibix panitumumab SOLUTION INTRAVENOUS 20061010 BLA BLA125147 Amgen Inc PANITUMUMAB 200 mg/10mL Epidermal Growth Factor Receptor Antagonist [EPC] 55513-956_707e93ca-2021-4591-b90d-717ee74c8335 55513-956 HUMAN PRESCRIPTION DRUG Vectibix panitumumab SOLUTION INTRAVENOUS 20061010 BLA BLA125147 Amgen Inc PANITUMUMAB 400 mg/20mL Epidermal Growth Factor Receptor Antagonist [EPC] 55526-0001_2124abe4-54f9-49f7-90ac-605880db7be8 55526-0001 HUMAN OTC DRUG NAVI Amazon Propol Sodium Monofluorophosphate Silicon Dioxide PASTE DENTAL 20130101 OTC MONOGRAPH FINAL part355 EQ Maxon Corp. SODIUM MONOFLUOROPHOSPHATE .228 g/120g 55526-0002_c4888dd7-09e0-4fde-9bb6-02482e6b920f 55526-0002 HUMAN OTC DRUG NAVI Mate Gold Sodium Monofluorophosphate Silicon Dioxide PASTE DENTAL 20130401 OTC MONOGRAPH FINAL part355 EQ Maxon Corp. SILICON DIOXIDE; SODIUM MONOFLUOROPHOSPHATE 21.36; .552 g/120g; g/120g 55526-0003_ac503a2f-0729-4a5c-a8ad-3735cf01804c 55526-0003 HUMAN OTC DRUG NAVI Mate Silver Sodium Monofluorophosphate Silicon Dioxide PASTE DENTAL 20130401 OTC MONOGRAPH FINAL part355 EQ Maxon Corp. SILICON DIOXIDE; SODIUM MONOFLUOROPHOSPHATE 21.36; .552 g/120g; g/120g 55526-0004_01092e9c-1fac-4315-b392-fe404e207900 55526-0004 HUMAN OTC DRUG NAVI MAXON Sirin Doctor Calcium Phosphate Tribasic Colloidal Silicon Dioxide PASTE DENTAL 20130401 OTC MONOGRAPH FINAL part331 EQ Maxon Corp. SILICON DIOXIDE; TRICALCIUM PHOSPHATE 3; 22.8 g/120g; g/120g 55526-0005_7e7ed651-e324-4cb0-b255-8fc155f8a115 55526-0005 HUMAN OTC DRUG NAVI Black and C-Clinic Calcium Carbonate Aminocaproic Acid Aluminum Chlorohydroxy Allantoinate Dibasic Calcium Phosphate PASTE DENTAL 20130401 OTC MONOGRAPH FINAL part331 EQ Maxon Corp. AMINOCAPROIC ACID; CALCIUM CARBONATE; DIBASIC CALCIUM PHOSPHATE DIHYDRATE .12; 48; .12 g/120g; g/120g; g/120g 55528-001_169f2a7e-4fb3-44e4-b588-44451a775dea 55528-001 HUMAN OTC DRUG DAILY ESSENTIAL MOISTURISER Homosalate, Octisalate, Avobenzone, Octocrylene, Oxybenzone LOTION TOPICAL 20130115 OTC MONOGRAPH FINAL part352 INTERNATIONAL WATERS PTY. LTD. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 40; 100; 50; 20; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 55531-001_abd6bda9-3994-4215-8e55-6c325f5c5516 55531-001 HUMAN OTC DRUG Medicated Green Oil MENTHOL, METHYL SALICYLATE OIL TOPICAL 20130702 OTC MONOGRAPH NOT FINAL part348 Allways Health-Care Corporation Limited MENTHOL; METHYL SALICYLATE 160; 300 mg/100mL; mg/100mL 55533-520_7c5737a4-71be-40c7-90e1-e10c2cd0b1d9 55533-520 HUMAN OTC DRUG HEALTHY HANDS ALOE INSTANT HAND ANTIBACTERIAL ALCOHOL SOAP TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part333E NCH Corporation ALCOHOL .62 mL/mL 55533-522_7a7a7ec5-30b6-418c-80ee-1be515e761e3 55533-522 HUMAN OTC DRUG Healthy Hands Instant Antiseptic Hand Cleanser ALCOHOL SOLUTION TOPICAL 20001101 OTC MONOGRAPH NOT FINAL part333E NCH Corporation ALCOHOL 42 mg/25mL 55533-529_46b0287f-15df-4788-be92-777d8d23de41 55533-529 HUMAN OTC DRUG HEALTHY HANDS PINK ANTIBACTERIAL HAND CLEANER CHLOROXYLENOL SOAP TOPICAL 20140121 OTC MONOGRAPH NOT FINAL part333E NCH Corporation CHLOROXYLENOL 2.5 g/1000mL 55533-556_ec761484-6e54-418c-86c6-0d326f484340 55533-556 HUMAN OTC DRUG HEALTHY HANDS INSTANT ANTISEPTIC HAND CLEANSER WITH MOISTURIZERS ALCOHOL SOAP TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333E NCH Corporation ALCOHOL .62 mL/mL 55533-682_85c28d80-ccc1-4d73-89a7-edd9fb33cf07 55533-682 HUMAN OTC DRUG HEALTHY HANDS SANITIZING HAND WIPES WITH ALOE BENZALKONIUM CHLORIDE CLOTH TOPICAL 20140429 OTC MONOGRAPH NOT FINAL part333E NCH Corporation BENZALKONIUM CHLORIDE .0067275 g/1 55546-0001_6bd93f15-cc88-4159-9b89-08a7c79945ec 55546-0001 HUMAN OTC DRUG Male Formula Plus Avena Sativa, Carduus Marianus, Damiana, Galium Aparine,Hamamelis Virginiana, Hepar Bovine, Korean Ginseng, Nuphar Luteum Tincture LIQUID ORAL 20130822 UNAPPROVED HOMEOPATHIC Yuen Method ASIAN GINSENG; AVENA SATIVA FLOWERING TOP; BEEF LIVER; BOS TAURUS TESTICLE; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; NUPHAR LUTEUM ROOT; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; SILYBUM MARIANUM SEED; TESTOSTERONE; THUJA OCCIDENTALIS LEAF; TURNERA DIFFUSA LEAFY TWIG 1; 1; 6; 6; 3; 1; 2; 1; 1; 1; 30; 200; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 55550-000_9ced89f9-e4a2-45e4-b425-e30649340e38 55550-000 HUMAN OTC DRUG FIRST AID Plus More ALCOHOL Prep Pad ALCOHOL LIQUID TOPICAL 20130130 OTC MONOGRAPH FINAL part333E Total Resources International Inc ALCOHOL 70 mL/100mL 55550-001_ca6d7a7d-ca71-41be-99f8-feb358a2be50 55550-001 HUMAN OTC DRUG FIRST AID Plus More Quick n Clean Antiseptic Hand Wipe BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130130 OTC MONOGRAPH FINAL part333E Total Resources International Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL 55550-030_94eb6951-7b31-412a-9d92-88865574f801 55550-030 HUMAN OTC DRUG Alcohol Prep Pads Isopropyl Alcohol LIQUID TOPICAL 20131107 OTC MONOGRAPH NOT FINAL part333A Total Resources International ISOPROPYL ALCOHOL .7 mL/mL 55550-031_f90ed16e-6c59-4c0b-86e1-00f813691493 55550-031 HUMAN OTC DRUG Sterile Alcohol Prep Pads Isopropyl Alcohol LIQUID TOPICAL 20131112 OTC MONOGRAPH NOT FINAL part333A Total Resources International ISOPROPYL ALCOHOL .7 mL/mL 55550-102_e4b994ea-01bf-40e9-9cbe-bb0807174ec2 55550-102 HUMAN OTC DRUG Sunscreen Homosalate, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20070313 OTC MONOGRAPH NOT FINAL part352 Total Resources International HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 6; 7.5; 5; 5 mg/g; mg/g; mg/g; mg/g 55550-200_5e11bc77-c763-455b-bab8-19b0b917a80b 55550-200 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333E Total Resources International BENZALKONIUM CHLORIDE 1.3 mg/mL 55560-0101_757dfc23-b1ba-4fb5-bfc4-fd771f4e155e 55560-0101 HUMAN OTC DRUG Andalou BB Untinted with SPF-30 Zinc Oxide LOTION TOPICAL 20121210 OTC MONOGRAPH FINAL part352 Andalou naturals ZINC OXIDE 20 g/100mL 55560-0102_1520ddfd-7577-43ce-a2fe-caeacd81870f 55560-0102 HUMAN OTC DRUG Andalou BB sheer tint with SPF-30 Zinc Oxide LOTION TOPICAL 20121210 OTC MONOGRAPH FINAL part352 Andalou naturals ZINC OXIDE 20 g/100mL 55566-0302_59a07c10-8730-4d46-9d8c-ebf772e3536c 55566-0302 HUMAN PRESCRIPTION DRUG Acthrel Corticorelin ovine triflutate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19960523 NDA NDA020162 Ferring Pharmaceuticals Inc. CORTICORELIN OVINE TRIFLUTATE 100 ug/2mL 55566-1501_059e684d-4403-4e1e-87a5-72f4ee7adb7e 55566-1501 HUMAN PRESCRIPTION DRUG Novarel Gonadotrophin, Chorionic KIT 19740115 NDA NDA017016 Ferring Pharmaceuticals Inc. 55566-2100_d5c99c20-6af4-42ba-82f3-1e5a72f5d305 55566-2100 HUMAN PRESCRIPTION DRUG Lysteda Tranexamic Acid TABLET ORAL 20100517 NDA NDA022430 Ferring Pharmaceuticals Inc. TRANEXAMIC ACID 650 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 55566-2110_5a58bf30-555e-4d7c-a9fc-05d6df198804 55566-2110 HUMAN PRESCRIPTION DRUG Lysteda Tranexamic Acid TABLET ORAL 20100517 NDA NDA022430 Ferring Pharmaceuticals Inc. TRANEXAMIC ACID 650 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 55566-5020_dbfe4d67-5335-5333-debb-428f6f991de6 55566-5020 HUMAN PRESCRIPTION DRUG Desmopressin Acetate desmopressin acetate SOLUTION NASAL 19990810 NDA NDA017922 Ferring Pharmaceuticals Inc. DESMOPRESSIN ACETATE .1 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 55566-5030_90bd1e51-06c1-61ab-fc0e-32c4dbd3b7a7 55566-5030 HUMAN PRESCRIPTION DRUG Desmopressin Acetate desmopressin acetate SOLUTION INTRAVENOUS 19991026 NDA NDA018938 Ferring Pharmaceuticals Inc. DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 55566-5040_90bd1e51-06c1-61ab-fc0e-32c4dbd3b7a7 55566-5040 HUMAN PRESCRIPTION DRUG Desmopressin Acetate desmopressin acetate SOLUTION INTRAVENOUS 19991026 NDA NDA018938 Ferring Pharmaceuticals Inc. DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 55566-5060_a3e1a3bc-b2d8-4947-87de-f1bb016fc8a3 55566-5060 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin acetate TABLET ORAL 20080505 NDA NDA021795 Ferring Pharmaceuticals Inc. DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 55566-5061_a3e1a3bc-b2d8-4947-87de-f1bb016fc8a3 55566-5061 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin acetate TABLET ORAL 20080505 NDA NDA021795 Ferring Pharmaceuticals Inc. DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 55566-6500_9ab6ab7c-f600-4468-bba2-e585d2289a89 55566-6500 HUMAN PRESCRIPTION DRUG Endometrin Progesterone INSERT VAGINAL 20070621 NDA NDA022057 Ferring Pharmaceuticals Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 55566-7501_18241629-ca79-4e9f-bb0f-867190857bf0 55566-7501 HUMAN PRESCRIPTION DRUG Menopur follitropin and luteinizing hormone KIT 20041029 NDA NDA021663 Ferring Pharmaceuticals Inc. 55566-8301_808c6144-4dd8-4cdc-a48d-5fac2cbee971 55566-8301 HUMAN PRESCRIPTION DRUG FIRMAGON degarelix POWDER, METERED SUBCUTANEOUS 20090302 20150331 NDA NDA022201 Ferring Pharmaceuticals Inc. DEGARELIX ACETATE 20 mg/mL 55566-8303_4ac58000-3067-4894-b541-e4b4590bbab5 55566-8303 HUMAN PRESCRIPTION DRUG FIRMAGON Degarelix KIT 20090302 NDA NDA022201 Ferring Pharmaceuticals Inc. 55566-8401_808c6144-4dd8-4cdc-a48d-5fac2cbee971 55566-8401 HUMAN PRESCRIPTION DRUG FIRMAGON degarelix POWDER, METERED SUBCUTANEOUS 20090302 20150331 NDA NDA022201 Ferring Pharmaceuticals Inc. DEGARELIX ACETATE 40 mg/mL 55566-8403_4ac58000-3067-4894-b541-e4b4590bbab5 55566-8403 HUMAN PRESCRIPTION DRUG FIRMAGON Degarelix KIT 20090302 NDA NDA022201 Ferring Pharmaceuticals Inc. 55566-8505_745d7ca1-bccb-476c-9d54-698d239699fa 55566-8505 HUMAN PRESCRIPTION DRUG Bravelle Urofollitropin KIT SUBCUTANEOUS 20020506 NDA NDA021289 Ferring Pharmaceuticals Inc. 55566-9300_9ff0ad37-190f-4b20-a277-2b701c0dab38 55566-9300 HUMAN PRESCRIPTION DRUG PREPOPIK SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID POWDER, METERED ORAL 20120716 NDA NDA202535 Ferring Pharmaceuticals Inc. ANHYDROUS CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE 12; 3.5; 10 g/16.1g; g/16.1g; mg/16.1g Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 55566-9500_9c6dfdbe-d7c1-474d-abb9-fafd3f9f5711 55566-9500 HUMAN PRESCRIPTION DRUG DINOPROSTONE DINOPROSTONE INSERT VAGINAL 20140201 NDA NDA020411 Ferring Pharmaceuticals Inc. DINOPROSTONE 10 mg/241mg Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 55566-9700_9ff0ad37-190f-4b20-a277-2b701c0dab38 55566-9700 HUMAN PRESCRIPTION DRUG PREPOPIK SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID POWDER, METERED ORAL 20140905 NDA NDA202535 Ferring Pharmaceuticals Inc. ANHYDROUS CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE 12; 3.5; 10 g/16.2g; g/16.2g; mg/16.2g Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 55586-001_5d9533f9-ee81-488b-99d6-e49f44733ee0 55586-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19710101 UNAPPROVED MEDICAL GAS Sims Welding Supply Co, Inc. OXYGEN 99 L/100L 55607-400_f12bc209-92f9-4c2c-9205-7a0c2ca1fd72 55607-400 HUMAN PRESCRIPTION DRUG Prastera prasterone and ibuprofen KIT ORAL 20140404 UNAPPROVED DRUG OTHER Health Science Funding, LLC 55618-1001_62bbe3ca-4f5c-4dab-a559-00cdbd1c0365 55618-1001 HUMAN OTC DRUG Jilgyungyi ALLANTOIN TABLET VAGINAL 20130611 UNAPPROVED DRUG OTHER HA U DONG CHUN ALLANTOIN .2 1/1 55621-001_4233a5e5-cd03-4828-8824-95396c86a484 55621-001 HUMAN OTC DRUG Thera Plus Hydrocortisone CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 Zhejiang Jingwei Pharmaceutical Co., Ltd. HYDROCORTISONE 1 g/100g 55621-002_7031fcd6-ab38-4fd0-9188-8a20156aab96 55621-002 HUMAN OTC DRUG TheraPlusPlus Plus NEOMYCIN OINTMENT TOPICAL 20130301 OTC MONOGRAPH FINAL part333B Zhejiang Jingwei Pharmaceutical Co., Ltd. BACITRACIN; NEOMYCIN; POLYMYXIN B .41; .0035; .52 g/100g; g/100g; g/100g 55621-003_9e9abe6d-0210-41d5-8cd0-e1985c46bbb3 55621-003 HUMAN OTC DRUG TheraPlus Plus CLOTRIMAZOLE CREAM TOPICAL 20130301 OTC MONOGRAPH FINAL part333C Zhejiang Jingwei Pharmaceutical Co., Ltd. CLOTRIMAZOLE 1 g/100g 55621-004_8cefcdd3-4abd-4bee-a23d-638f6139c459 55621-004 HUMAN OTC DRUG TheraPlus Plus Menthol OINTMENT TOPICAL 20130301 OTC MONOGRAPH FINAL part348 Zhejiang Jingwei Pharmaceutical Co., Ltd. MENTHOL; MENTHYL SALICYLATE, (+/-)- 10; 15 g/100g; g/100g 55621-005_82084c58-86b2-4fe2-a5b5-7ea76b7efc63 55621-005 HUMAN OTC DRUG TheraPlus Plus Phenylephrine HCI OINTMENT TOPICAL 20130301 OTC MONOGRAPH FINAL part346 Zhejiang Jingwei Pharmaceutical Co., Ltd. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 55621-006_80425369-2751-46f7-8b55-416e08435e9e 55621-006 HUMAN OTC DRUG Family Wellness Phenylephrine HCI, PETROLATUM, MINERAL OIL OINTMENT RECTAL; TOPICAL 20131101 OTC MONOGRAPH FINAL part346 Zhejiang Jingwei Pharmaceutical Co., Ltd. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 55621-007_86b3a888-70c2-4784-910c-6fdfd8a94345 55621-007 HUMAN OTC DRUG Family Wellness DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part348 Zhejiang Jingwei Pharmaceutical Co., Ltd. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 55621-008_40733a11-a835-40a3-b762-f96cbb53180b 55621-008 HUMAN OTC DRUG Family Wellness Hydrocortisone CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 Zhejiang Jingwei Pharmaceutical Co., Ltd. HYDROCORTISONE 1 g/100g 55621-009_848dc2d4-16e0-43e9-9311-ebdae28d3cdf 55621-009 HUMAN OTC DRUG Family Wellness NEOMYCIN, BACITRACIN, POLYMYXIN OINTMENT TOPICAL 20130301 OTC MONOGRAPH FINAL part333B Zhejiang Jingwei Pharmaceutical Co., Ltd. BACITRACIN; NEOMYCIN; POLYMYXIN B .41; .0035; .52 g/100g; g/100g; g/100g 55621-010_272a9428-b197-4680-a605-7338660d5c39 55621-010 HUMAN OTC DRUG Assured LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part348 Zhejiang Jingwei Pharmaceutical Co., Ltd. LIDOCAINE HYDROCHLORIDE 2.5 g/100g 55628-1001_64cb6819-dc8d-408c-b19d-5791a4a96723 55628-1001 HUMAN OTC DRUG ULTRA THERAPY PAIN RELIEF MENTHOL, METHYL SALICYLATE, CAPSAICIN LOTION TOPICAL 20121129 OTC MONOGRAPH NOT FINAL part348 Cal Pharma CAPSAICIN; MENTHOL; METHYL SALICYLATE .025; 10; 28 g/100mL; g/100mL; g/100mL 55628-9109_2889fdb4-365d-4adb-840e-b4257c173427 55628-9109 HUMAN OTC DRUG THERASEPTIN ZINC OXIDE MENTHOL OINTMENT TOPICAL 20121129 OTC MONOGRAPH FINAL part347 Cal Pharma MENTHOL; ZINC OXIDE .5; 20.6 g/100mL; g/100mL 55628-9155_5ac733c8-3e67-4cd7-8500-f99e18bb52f4 55628-9155 HUMAN OTC DRUG THERAZCREAM TRICLOSAN CREAM TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part333A Cal Pharma TRICLOSAN .3 g/100mL 55628-9179_87019aa1-d73a-46c5-9a26-d3f7524ca11f 55628-9179 HUMAN OTC DRUG ULTRACIN METHYL SALICYLATE, MENTHOL, CAPSAICIN LOTION TOPICAL 20121129 OTC MONOGRAPH NOT FINAL part348 Cal Pharma CAPSAICIN; MENTHOL; METHYL SALICYLATE 25; 10; 28 mg/100mL; g/100mL; g/100mL 55628-9204_d1d12c3e-0c3c-4289-8244-ab4db423682f 55628-9204 HUMAN OTC DRUG THERASEPTIN ZINC OXIDE, MENTHOL OINTMENT TOPICAL 20121129 OTC MONOGRAPH FINAL part347 Cal Pharma MENTHOL; ZINC OXIDE .5; 20.6 g/100mL; g/100mL 55636-590_4ae9e446-dfbe-4163-9a8b-7d75c1f501f4 55636-590 HUMAN OTC DRUG Promescent Lidicaine SPRAY TOPICAL 20130111 OTC MONOGRAPH FINAL part348 Absorption LIDOCAINE 10 g/100g 55648-101_572fcaa4-314e-42b2-aa6b-f5ec54da6199 55648-101 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (SR) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120830 ANDA ANDA201331 Wockhardt Limited BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 55648-102_8f747864-3731-4107-bf58-155366dc8ec9 55648-102 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121121 ANDA ANDA202189 Wockhardt Limited BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 55648-105_572fcaa4-314e-42b2-aa6b-f5ec54da6199 55648-105 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (SR) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120830 ANDA ANDA201331 Wockhardt Limited BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 55648-107_572fcaa4-314e-42b2-aa6b-f5ec54da6199 55648-107 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (SR) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120830 ANDA ANDA201331 Wockhardt Limited BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 55648-140_f93c2a1e-e11b-4b97-a282-29d0dbb1b8c9 55648-140 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202727 Wockhardt Limited LANSOPRAZOLE 15 mg/1 55648-152_88df95c2-5088-4980-9d78-2d1760033ba7 55648-152 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED ORAL 20100524 ANDA ANDA090216 Wockhardt Limited VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55648-153_88df95c2-5088-4980-9d78-2d1760033ba7 55648-153 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED ORAL 20100524 ANDA ANDA090216 Wockhardt Limited VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 55648-154_04e661d1-6156-43d0-abbd-64be8eca1666 55648-154 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt Limited ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55648-155_04e661d1-6156-43d0-abbd-64be8eca1666 55648-155 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt Limited ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55648-171_04e661d1-6156-43d0-abbd-64be8eca1666 55648-171 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55648-172_04e661d1-6156-43d0-abbd-64be8eca1666 55648-172 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55648-174_04e661d1-6156-43d0-abbd-64be8eca1666 55648-174 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55648-175_04e661d1-6156-43d0-abbd-64be8eca1666 55648-175 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55648-177_04e661d1-6156-43d0-abbd-64be8eca1666 55648-177 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55648-185_e385374d-41df-4e59-a74d-6dad0d7dacee 55648-185 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION INTRAVENOUS 20130302 ANDA ANDA203070 Wockhardt Limited ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 55648-186_efd91c83-22ed-4ef6-a09c-dfa0a1f4889b 55648-186 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION INTRAVENOUS 20130302 ANDA ANDA203069 Wockhardt Limited ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 55648-215_13a19063-0185-47a3-8153-199fc69d73a8 55648-215 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20120815 ANDA ANDA201948 Wockhardt Limited DICLOFENAC SODIUM; MISOPROSTOL 50; .2 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 55648-217_13a19063-0185-47a3-8153-199fc69d73a8 55648-217 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20120815 ANDA ANDA201948 Wockhardt Limited DICLOFENAC SODIUM; MISOPROSTOL 75; .2 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 55648-271_ddc5823c-ca8f-4f63-9d7b-d54c82798452 55648-271 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55648-272_ddc5823c-ca8f-4f63-9d7b-d54c82798452 55648-272 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt Limited LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55648-273_ddc5823c-ca8f-4f63-9d7b-d54c82798452 55648-273 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt Limited LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55648-274_ddc5823c-ca8f-4f63-9d7b-d54c82798452 55648-274 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt Limited LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55648-275_ddc5823c-ca8f-4f63-9d7b-d54c82798452 55648-275 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt Limited LAMOTRIGINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55648-290_ec3c430e-e3b9-4871-91d0-77d58a020431 55648-290 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20120930 NDA AUTHORIZED GENERIC NDA020796 Wockhardt Limited ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 55648-311_63aed8fa-52e1-4e47-91ed-cb7fd6b8cce0 55648-311 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA091267 Wockhardt Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55648-312_63aed8fa-52e1-4e47-91ed-cb7fd6b8cce0 55648-312 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA091267 Wockhardt Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 55648-314_79a0b285-80de-4b38-9d3f-37fb165ef36b 55648-314 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120522 ANDA ANDA202266 Wockhardt Limited CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 55648-315_79a0b285-80de-4b38-9d3f-37fb165ef36b 55648-315 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20121113 ANDA ANDA202266 Wockhardt Limited CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 55648-374_d0e9c888-c641-40a8-9338-d83b6de02385 55648-374 HUMAN OTC DRUG FAMOTIDINE FAMOTIDINE TABLET ORAL 20100806 ANDA ANDA090837 WOCKHARDT LIMITED FAMOTIDINE 20 mg/1 55648-411_a0bf854d-54eb-42f1-891b-3facd48042f0 55648-411 HUMAN PRESCRIPTION DRUG FELODIPINE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101205 ANDA ANDA091484 WOCKHARDT LIMITED FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55648-412_a0bf854d-54eb-42f1-891b-3facd48042f0 55648-412 HUMAN PRESCRIPTION DRUG FELODIPINE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101205 ANDA ANDA091484 WOCKHARDT LIMITED FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55648-414_a0bf854d-54eb-42f1-891b-3facd48042f0 55648-414 HUMAN PRESCRIPTION DRUG FELODIPINE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101205 ANDA ANDA091484 WOCKHARDT LIMITED FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55648-421_bc38c309-978f-47ec-9357-aa73b81f9c39 55648-421 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070906 ANDA ANDA078500 WOCKHARDT LIMITED AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55648-422_bc38c309-978f-47ec-9357-aa73b81f9c39 55648-422 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070906 ANDA ANDA078500 WOCKHARDT LIMITED AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55648-423_bc38c309-978f-47ec-9357-aa73b81f9c39 55648-423 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070906 ANDA ANDA078500 WOCKHARDT LIMITED AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55648-433_ff0dc161-4748-415c-ba20-bdfff819c611 55648-433 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA091231 WOCKHARDT LIMITED PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55648-434_ff0dc161-4748-415c-ba20-bdfff819c611 55648-434 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA091231 WOCKHARDT LIMITED PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55648-447_fda4671d-cce2-44b4-b41c-caa6ca7ecbec 55648-447 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE HYDROCHLORIDE TABLET ORAL 20091211 ANDA ANDA078701 WOCKHARDT LIMITED RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55648-516_dde247ce-2fbe-4071-9af7-446d65376ec2 55648-516 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100427 ANDA ANDA078938 WOCKHARDT LIMITED TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55648-544_48b9f69b-8df6-40da-b1ff-ba2965853fe8 55648-544 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Wockhardt Limited LEVOFLOXACIN 250 mg/1 55648-545_48b9f69b-8df6-40da-b1ff-ba2965853fe8 55648-545 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Wockhardt Limited LEVOFLOXACIN 500 mg/1 55648-547_48b9f69b-8df6-40da-b1ff-ba2965853fe8 55648-547 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Wockhardt Limited LEVOFLOXACIN 750 mg/1 55648-553_aaa62d0c-37d5-40a9-8940-2f2b7397197f 55648-553 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT LIMITED RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 55648-554_aaa62d0c-37d5-40a9-8940-2f2b7397197f 55648-554 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT LIMITED RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 55648-555_aaa62d0c-37d5-40a9-8940-2f2b7397197f 55648-555 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT LIMITED RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 55648-557_aaa62d0c-37d5-40a9-8940-2f2b7397197f 55648-557 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT LIMITED RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 55648-571_aaa62d0c-37d5-40a9-8940-2f2b7397197f 55648-571 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT LIMITED RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 55648-572_aaa62d0c-37d5-40a9-8940-2f2b7397197f 55648-572 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT LIMITED RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 55648-630_2003e556-60bd-4127-ab47-324acb610460 55648-630 HUMAN PRESCRIPTION DRUG ADENOSINE ADENOSINE INJECTION INTRAVENOUS 20130330 ANDA ANDA079147 Wockhardt Limited ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 55648-630_f0ace3f7-9353-4709-a5a5-ea7686286a67 55648-630 HUMAN PRESCRIPTION DRUG ADENOSINE ADENOSINE INJECTION INTRAVENOUS 20090720 ANDA ANDA090220 WOCKHARDT LIMITED ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 55648-631_1aa072e3-8f11-4e34-8d13-bc0021f33713 55648-631 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION INTRAVENOUS 20091109 ANDA ANDA090671 Wockhardt Limited NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55648-632_3612a4d7-791d-4f11-aab1-4aefb5203bf1 55648-632 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090986 Wockhardt Limited OCTREOTIDE ACETATE 1000 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 55648-633_3612a4d7-791d-4f11-aab1-4aefb5203bf1 55648-633 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090985 Wockhardt Limited OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 55648-634_3612a4d7-791d-4f11-aab1-4aefb5203bf1 55648-634 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090986 Wockhardt Limited OCTREOTIDE ACETATE 200 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 55648-635_3612a4d7-791d-4f11-aab1-4aefb5203bf1 55648-635 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090985 Wockhardt Limited OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 55648-636_3612a4d7-791d-4f11-aab1-4aefb5203bf1 55648-636 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090985 Wockhardt Limited OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 55648-661_dae3e3e8-5de8-412f-9b98-6443c9d2edc0 55648-661 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20080630 ANDA ANDA078564 WOCKHARDT LIMITED GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55648-661_e6ecd37b-72e8-48e2-b8ec-d4637c4d44a3 55648-661 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20080630 ANDA ANDA078565 WOCKHARDT LIMITED GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55648-662_ac38ecc1-4f9d-4c72-88d5-c3caf3bf2b51 55648-662 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20080303 ANDA ANDA078566 WOCKHARDT LIMITED GRANISETRON HYDROCHLORIDE .1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55648-669_ad574d8c-de35-45d3-8cdb-4f56e18ec0d9 55648-669 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120810 ANDA ANDA202176 Wockhardt Limited LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55648-670_ad574d8c-de35-45d3-8cdb-4f56e18ec0d9 55648-670 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120810 ANDA ANDA202176 Wockhardt Limited LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55648-692_a0cd87aa-d540-4d98-800a-15b909dbbee3 55648-692 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE SOLUTION ORAL 20091014 ANDA ANDA078744 WOCKHARDT LIMITED RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] 55648-694_d2bbcbe8-36ec-4631-8469-7d1911797403 55648-694 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE HYDROCHLORIDE SYRUP ORAL 20090526 ANDA ANDA079211 WOCKHARDT LIMITED RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55648-701_c1e4e700-831e-4a4a-8165-b147660dde4f 55648-701 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070412 ANDA ANDA065391 Wockhardt Limited CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55648-702_c1e4e700-831e-4a4a-8165-b147660dde4f 55648-702 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070412 ANDA ANDA065391 Wockhardt Limited CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55648-703_c1e4e700-831e-4a4a-8165-b147660dde4f 55648-703 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070412 ANDA ANDA065391 Wockhardt Limited CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55648-711_419accad-98ef-4290-ba9c-be6a387a0202 55648-711 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20120816 ANDA ANDA078941 Wockhardt Limited ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 55648-712_ba6f00bd-79a2-46c1-87fa-054b258903ee 55648-712 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET, FILM COATED ORAL 20070615 ANDA ANDA065428 Wockhardt Limited CEFPROZIL 250 mg/1 55648-713_ba6f00bd-79a2-46c1-87fa-054b258903ee 55648-713 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET, FILM COATED ORAL 20070615 ANDA ANDA065428 Wockhardt Limited CEFPROZIL 500 mg/1 55648-714_1818aead-1bb7-45f5-88f2-4278bbccc8fc 55648-714 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET, FILM COATED ORAL 20070515 ANDA ANDA078426 Wockhardt Limited ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55648-715_1818aead-1bb7-45f5-88f2-4278bbccc8fc 55648-715 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET, FILM COATED ORAL 20070515 ANDA ANDA078426 Wockhardt Limited ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 55648-716_cd51dc6a-6737-49ce-b330-bb8cd16d8542 55648-716 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110414 ANDA ANDA078865 Wockhardt Limited VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55648-717_cd51dc6a-6737-49ce-b330-bb8cd16d8542 55648-717 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110414 ANDA ANDA078865 Wockhardt Limited VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55648-718_cd51dc6a-6737-49ce-b330-bb8cd16d8542 55648-718 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110414 ANDA ANDA078865 Wockhardt Limited VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55648-720_21c147fd-c3a2-4c0d-b8a0-4370bebc33f0 55648-720 HUMAN PRESCRIPTION DRUG EXTENDED PHENYTOIN SODIUM EXTENDED PHENYTOIN SODIUM CAPSULE ORAL 20080130 ANDA ANDA040732 Wockhardt Limited PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55648-724_f8aa46d8-270b-48ea-95fc-5febb7b8ddab 55648-724 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM ER DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090210 ANDA ANDA078705 WOCKHARDT LIMITED DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55648-725_f8aa46d8-270b-48ea-95fc-5febb7b8ddab 55648-725 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM ER DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA078705 WOCKHARDT LIMITED DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55648-726_eaf9d55f-60bd-4db7-8919-3e2d7103a4e6 55648-726 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20061227 ANDA ANDA077716 WOCKHARDT LIMITED ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55648-727_eaf9d55f-60bd-4db7-8919-3e2d7103a4e6 55648-727 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20061227 ANDA ANDA077577 WOCKHARDT LIMITED ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 55648-728_677214c1-8f46-4345-8dae-8f0bb97154fc 55648-728 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate INJECTION SUBCUTANEOUS 20090206 ANDA ANDA078593 Wockhardt Limited SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 55648-734_47a324a2-9549-4f0e-ba7f-4259338b3f36 55648-734 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Wockhardt Limited METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55648-735_47a324a2-9549-4f0e-ba7f-4259338b3f36 55648-735 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Wockhardt Limited METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55648-736_47a324a2-9549-4f0e-ba7f-4259338b3f36 55648-736 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Wockhardt Limited METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55648-737_47a324a2-9549-4f0e-ba7f-4259338b3f36 55648-737 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Wockhardt Limited METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 55648-738_684641a9-69ac-47dc-9fc5-3dc6c9b4028c 55648-738 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET ORAL 20120815 ANDA ANDA090221 Wockhardt Limited ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 55648-739_e11649f1-cacd-4246-ba5c-c45407d16c93 55648-739 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION INTRAVENOUS 20081030 ANDA ANDA077610 Wockhardt Limited AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 55648-740_f60514be-7bf5-48bb-9a26-e1a70b7e74c1 55648-740 HUMAN OTC DRUG RANITIDINE RANITIDINE TABLET, COATED ORAL 20080731 ANDA ANDA078884 WOCKHARDT LIMITED RANITIDINE HYDROCHLORIDE 75 mg/1 55648-741_e0f509b6-6e58-4f2d-8abf-84d4852cf9a2 55648-741 HUMAN OTC DRUG RANITIDINE RANITIDINE TABLET, COATED ORAL 20071126 ANDA ANDA078653 WOCKHARDT LIMITED RANITIDINE HYDROCHLORIDE 150 mg/1 55648-742_fda4671d-cce2-44b4-b41c-caa6ca7ecbec 55648-742 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE HYDROCHLORIDE TABLET ORAL 20091211 ANDA ANDA078701 WOCKHARDT LIMITED RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55648-743_dfe33d51-4932-412a-a90f-47007dc507cb 55648-743 HUMAN PRESCRIPTION DRUG TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE TABLET ORAL 20070702 ANDA ANDA078229 Wockhardt Limited TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 55648-744_865eb588-6553-4222-b98e-3759fab38f2d 55648-744 HUMAN OTC DRUG Fexofenadine Fexofenadine TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt Limited FEXOFENADINE HYDROCHLORIDE 30 mg/1 55648-757_a12b2b3e-bac4-4cd6-a104-24283bc0f02e 55648-757 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR; INTRAVENOUS 20070327 ANDA ANDA077942 WOCKHARDT LIMITED KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55648-758_a12b2b3e-bac4-4cd6-a104-24283bc0f02e 55648-758 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR; INTRAVENOUS 20070327 ANDA ANDA077942 WOCKHARDT LIMITED KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 55648-762_78b2a31c-22dd-42f7-8085-c32010d52256 55648-762 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20080530 ANDA ANDA078141 Wockhardt Limited MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55648-763_78b2a31c-22dd-42f7-8085-c32010d52256 55648-763 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20080530 ANDA ANDA078141 Wockhardt Limited MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55648-764_cc33c428-6db9-428c-8f4d-f575f27b60b8 55648-764 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20081110 ANDA ANDA078511 Wockhardt Limited MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55648-765_cc33c428-6db9-428c-8f4d-f575f27b60b8 55648-765 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20081110 ANDA ANDA078511 Wockhardt Limited MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 55648-771_62d19008-0fd5-4b90-a910-10bd48ac265a 55648-771 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55648-773_62d19008-0fd5-4b90-a910-10bd48ac265a 55648-773 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55648-774_62d19008-0fd5-4b90-a910-10bd48ac265a 55648-774 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55648-775_62d19008-0fd5-4b90-a910-10bd48ac265a 55648-775 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55648-776_62d19008-0fd5-4b90-a910-10bd48ac265a 55648-776 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 55648-780_e11649f1-cacd-4246-ba5c-c45407d16c93 55648-780 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION INTRAVENOUS 20081030 ANDA ANDA077834 Wockhardt Limited AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 55648-781_db131736-7c7c-4f65-b2ee-b3d5f8e76ead 55648-781 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20120930 NDA AUTHORIZED GENERIC NDA020796 Wockhardt Limited ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 55648-782_9866a9f3-77fb-43ec-b516-2a4dac01e1cc 55648-782 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt Limited CARBIDOPA; ENTACAPONE; LEVODOPA 12.5; 200; 50 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 55648-783_9866a9f3-77fb-43ec-b516-2a4dac01e1cc 55648-783 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt Limited CARBIDOPA; ENTACAPONE; LEVODOPA 18.75; 200; 75 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 55648-784_9866a9f3-77fb-43ec-b516-2a4dac01e1cc 55648-784 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt Limited CARBIDOPA; ENTACAPONE; LEVODOPA 25; 200; 100 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 55648-785_9866a9f3-77fb-43ec-b516-2a4dac01e1cc 55648-785 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt Limited CARBIDOPA; ENTACAPONE; LEVODOPA 31.25; 200; 125 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 55648-786_9866a9f3-77fb-43ec-b516-2a4dac01e1cc 55648-786 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt Limited CARBIDOPA; ENTACAPONE; LEVODOPA 37.5; 200; 150 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 55648-787_9866a9f3-77fb-43ec-b516-2a4dac01e1cc 55648-787 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt Limited CARBIDOPA; ENTACAPONE; LEVODOPA 50; 200; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 55648-902_a23c9856-4839-4614-a57a-6ad4491164cf 55648-902 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 19970328 ANDA ANDA074532 Wockhardt Limited CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55648-903_a23c9856-4839-4614-a57a-6ad4491164cf 55648-903 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Wockhardt Limited CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55648-904_a23c9856-4839-4614-a57a-6ad4491164cf 55648-904 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Wockhardt Limited CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55648-905_a23c9856-4839-4614-a57a-6ad4491164cf 55648-905 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Wockhardt Limited CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 55648-906_fbd61078-7ec6-4081-a730-4de11b7087a7 55648-906 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 19981217 ANDA ANDA075208 WOCKHARDT LIMITED RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55648-907_fbd61078-7ec6-4081-a730-4de11b7087a7 55648-907 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 19981217 ANDA ANDA075208 WOCKHARDT LIMITED RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55648-920_bf9f17a4-2bc9-4599-b142-806ef9700a74 55648-920 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 Wockhardt Limited CEFUROXIME AXETIL 125 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55648-921_bf9f17a4-2bc9-4599-b142-806ef9700a74 55648-921 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 Wockhardt Limited CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55648-922_bf9f17a4-2bc9-4599-b142-806ef9700a74 55648-922 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 Wockhardt Limited CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55648-923_93619dcf-3818-4ffa-b605-265377a9da2b 55648-923 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Wockhardt Limited ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55648-924_93619dcf-3818-4ffa-b605-265377a9da2b 55648-924 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Wockhardt Limited ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55648-925_93619dcf-3818-4ffa-b605-265377a9da2b 55648-925 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Wockhardt Limited ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55648-926_93619dcf-3818-4ffa-b605-265377a9da2b 55648-926 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Wockhardt Limited ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55648-927_f68b2093-d117-4a59-aa38-83fbe1e48e87 55648-927 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt Limited LISINOPRIL 2.5 mg/1 55648-928_f68b2093-d117-4a59-aa38-83fbe1e48e87 55648-928 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt Limited LISINOPRIL 5 mg/1 55648-929_f68b2093-d117-4a59-aa38-83fbe1e48e87 55648-929 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt Limited LISINOPRIL 10 mg/1 55648-936_b0208b67-58f7-4e87-9dc2-48cb6d9d9790 55648-936 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 Wockhardt Limited FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55648-937_b0208b67-58f7-4e87-9dc2-48cb6d9d9790 55648-937 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 Wockhardt Limited FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 55648-941_f68b2093-d117-4a59-aa38-83fbe1e48e87 55648-941 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt Limited LISINOPRIL 20 mg/1 55648-942_f68b2093-d117-4a59-aa38-83fbe1e48e87 55648-942 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt Limited LISINOPRIL 40 mg/1 55648-945_bcc27cd7-e3ac-4ec3-ba94-7bcaaf9bcf10 55648-945 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060727 ANDA ANDA077636 WOCKHARDT LIMITED ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55648-946_bcc27cd7-e3ac-4ec3-ba94-7bcaaf9bcf10 55648-946 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060727 ANDA ANDA077636 WOCKHARDT LIMITED ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55648-947_ae6f86a8-6a5c-4c3a-a8cb-aee20b427b5b 55648-947 HUMAN PRESCRIPTION DRUG CEFOTAXIME CEFOTAXIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080620 ANDA ANDA065197 WOCKHARDT LIMITED CEFOTAXIME SODIUM 500 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55648-948_ae6f86a8-6a5c-4c3a-a8cb-aee20b427b5b 55648-948 HUMAN PRESCRIPTION DRUG CEFOTAXIME CEFOTAXIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080620 ANDA ANDA065197 WOCKHARDT LIMITED CEFOTAXIME SODIUM 2 g/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55648-949_33ad64a4-7952-474e-baad-0c6f7528d06a 55648-949 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20060531 ANDA ANDA065266 Wockhardt Limited CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 55648-953_f68b2093-d117-4a59-aa38-83fbe1e48e87 55648-953 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt Limited LISINOPRIL 30 mg/1 55648-954_33ad64a4-7952-474e-baad-0c6f7528d06a 55648-954 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20060531 ANDA ANDA065266 Wockhardt Limited CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 55648-961_e25928bc-ff72-4b62-b372-c50a7a3b9960 55648-961 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 WOCKHARDT LIMITED AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55648-962_a83b5bd6-9e8e-4d1b-abc2-d27f28223598 55648-962 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065302 WOCKHARDT LIMITED AZITHROMYCIN ANHYDROUS 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55648-964_e25928bc-ff72-4b62-b372-c50a7a3b9960 55648-964 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065405 WOCKHARDT LIMITED AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 55648-965_a3ff540a-0e67-4d4c-ab96-b80b28373771 55648-965 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20030929 ANDA ANDA040532 Wockhardt Limited BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 55648-966_a3ff540a-0e67-4d4c-ab96-b80b28373771 55648-966 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20030929 ANDA ANDA040533 Wockhardt Limited BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 55648-967_a3ff540a-0e67-4d4c-ab96-b80b28373771 55648-967 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20030929 ANDA ANDA040534 Wockhardt Limited BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 55648-968_a3ff540a-0e67-4d4c-ab96-b80b28373771 55648-968 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20030929 ANDA ANDA040518 Wockhardt Limited BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 55648-973_bf372a2f-7f7c-45dc-963c-083c87feb354 55648-973 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE ORAL 20080731 ANDA ANDA077296 WOCKHARDT LIMITED DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55648-974_bf372a2f-7f7c-45dc-963c-083c87feb354 55648-974 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE ORAL 20080731 ANDA ANDA077296 WOCKHARDT LIMITED DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55648-975_bf372a2f-7f7c-45dc-963c-083c87feb354 55648-975 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE ORAL 20080731 ANDA ANDA077296 WOCKHARDT LIMITED DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 55648-976_6b9cd601-bdd6-48fa-9988-63abfa1f7e3c 55648-976 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130213 ANDA ANDA078038 Wockhardt Limited PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 55648-977_6b9cd601-bdd6-48fa-9988-63abfa1f7e3c 55648-977 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130213 ANDA ANDA078038 Wockhardt Limited PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 55648-978_6b9cd601-bdd6-48fa-9988-63abfa1f7e3c 55648-978 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130213 ANDA ANDA078038 Wockhardt Limited PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 55648-982_865eb588-6553-4222-b98e-3759fab38f2d 55648-982 HUMAN OTC DRUG Fexofenadine Fexofenadine TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt Limited FEXOFENADINE HYDROCHLORIDE 60 mg/1 55648-983_c1e4e700-831e-4a4a-8165-b147660dde4f 55648-983 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060512 ANDA ANDA065180 Wockhardt Limited CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55648-986_ae6f86a8-6a5c-4c3a-a8cb-aee20b427b5b 55648-986 HUMAN PRESCRIPTION DRUG CEFOTAXIME CEFOTAXIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060829 ANDA ANDA065197 WOCKHARDT LIMITED CEFOTAXIME SODIUM 1 g/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55648-987_865eb588-6553-4222-b98e-3759fab38f2d 55648-987 HUMAN OTC DRUG Fexofenadine Fexofenadine TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt Limited FEXOFENADINE HYDROCHLORIDE 180 mg/1 55648-990_bcc27cd7-e3ac-4ec3-ba94-7bcaaf9bcf10 55648-990 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20051222 ANDA ANDA077636 WOCKHARDT LIMITED ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55648-991_a1ced08e-5f3f-4d84-a39f-507734086ae2 55648-991 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 Wockhardt Limited ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 55648-992_a1ced08e-5f3f-4d84-a39f-507734086ae2 55648-992 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 Wockhardt Limited ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 55648-993_a1ced08e-5f3f-4d84-a39f-507734086ae2 55648-993 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 Wockhardt Limited ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 55648-994_a1ced08e-5f3f-4d84-a39f-507734086ae2 55648-994 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 Wockhardt Limited ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 55651-005_dacfe618-34c9-48a7-a078-0961cbcb3d61 55651-005 HUMAN OTC DRUG Eye Drops Regular Tetrahydrozoline hydrochloride SOLUTION/ DROPS OPHTHALMIC 20030828 OTC MONOGRAPH FINAL part349 KC Pharmaceuticals, Inc. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 55651-008_b646c9ae-1151-46da-9a2e-8d11c23cff46 55651-008 HUMAN OTC DRUG Artificial Tears Polyvinyl alcohol, Povidone SOLUTION/ DROPS OPHTHALMIC 20031125 OTC MONOGRAPH FINAL part349 KC Pharmaceuticals, Inc. POLYVINYL ALCOHOL; POVIDONE 5; 6 mg/mL; mg/mL 55651-012_05d1bdb4-1d77-47ef-95e9-e418c9ee2a9b 55651-012 HUMAN OTC DRUG Eye Drops Extra Tetrahydrozoline hydrochloride, Polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20031209 OTC MONOGRAPH FINAL part349 KC Pharmaceuticals, Inc. POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE 10; .5 mg/mL; mg/mL 55651-024_368dcefa-1617-4e8b-8f03-2f660b2baaa4 55651-024 HUMAN OTC DRUG Eye Drops AC Tetrahydrozoline hydrochloride, Zinc sulfate SOLUTION/ DROPS OPHTHALMIC 20031023 OTC MONOGRAPH FINAL part349 KC Pharmaceuticals, Inc. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL 55651-025_e647058b-7791-4ca8-861e-895925872480 55651-025 HUMAN OTC DRUG Eye Drops Advanced Relief Tetrahydrozoline hydrochloride, Polyethylene glycol 400, Dextran 70, Povidone SOLUTION/ DROPS OPHTHALMIC 20031209 OTC MONOGRAPH FINAL part349 KC Pharmaceuticals, Inc. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL 55651-026_584b030c-552a-499d-95b1-9ff4c07fe0d1 55651-026 HUMAN OTC DRUG Eye Drops Lubricating Tears Hypromellose, Glycerin, Polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20080512 OTC MONOGRAPH FINAL part349 KC Pharmaceuticals, Inc. GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2; 2; 10 mg/mL; mg/mL; mg/mL 55651-028_58b372ae-43f2-4aba-8016-da1c7ace8e3f 55651-028 HUMAN OTC DRUG Eye Drops SY Polyethylene glycol 400, Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20100317 OTC MONOGRAPH FINAL part349 KC Pharmaceuticals, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL 55651-050_99f482ad-9dea-492b-9f52-b85625215cfe 55651-050 HUMAN OTC DRUG Eye Drops Redness and Dry Eye Relief Naphazoline hydrochloride, Glycerin SOLUTION/ DROPS OPHTHALMIC 20071022 OTC MONOGRAPH FINAL part349 KC Pharmaceuticals, Inc. GLYCERIN; NAPHAZOLINE HYDROCHLORIDE 2; .12 mg/mL; mg/mL 55651-264_41e599f4-9fe4-4b38-881d-17302f6e1d7a 55651-264 HUMAN OTC DRUG Pepbis Regular Bismuth subslicylate SUSPENSION ORAL 20040304 OTC MONOGRAPH FINAL part335 KC Pharmaceuticals, Inc. BISMUTH SUBSALICYLATE 17.5 mg/mL 55653-0001_2e3614be-e5df-4245-b5cc-540e4a92834c 55653-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19851107 UNAPPROVED MEDICAL GAS Home MediService, Inc. OXYGEN 99 L/100L 55655-120_89646782-0b06-4168-bcb2-6a5bc0be387d 55655-120 HUMAN OTC DRUG LIVESTS Titanium dioxide CREAM TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 ARSOA USA INC. TITANIUM DIOXIDE 2.522 g/25mL 55655-121_e6157f02-7754-4abc-bb9f-2107f07e407f 55655-121 HUMAN OTC DRUG LIVESTS Moist Liquid TITANIUM DIOXIDE LIQUID TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 ARSOA USA INC. TITANIUM DIOXIDE 3.09 g/30mL 55655-122_45145c91-7570-4c19-9f94-49903f1f0008 55655-122 HUMAN OTC DRUG LIVESTS Moist Liquid TITANIUM DIOXIDE LIQUID TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 ARSOA USA INC. TITANIUM DIOXIDE 3.09 g/30mL 55655-123_d279ebec-3d6c-434e-888f-02ce7df4dcb8 55655-123 HUMAN OTC DRUG LIVESTS Moist Liquid TITANIUM DIOXIDE LIQUID TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 ARSOA USA INC. TITANIUM DIOXIDE 3.09 g/30mL 55662-0117_c9d9232a-31ea-41d5-8355-cec79c6d70bb 55662-0117 HUMAN OTC DRUG HemOral Aesculus hippocastanum, Aloe socotrina, Apis mellifica, Bryonia, Calcarea fluorica, Carbo vegetabilis, Causticum, Collinsonia canadensis, Echinacea angustifolia, Hamamelis virginiana, Lycopodium clavatum, Sulphur LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Alchemed ACTIVATED CHARCOAL; ALOE; APIS MELLIFERA; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; LYCOPODIUM CLAVATUM SPORE; SULFUR 10; 4; 4; 4; 8; 6; 3; 3; 3; 3; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55670-050_6fd0e7e7-5d2f-46aa-b86f-9b6e9e256275 55670-050 HUMAN OTC DRUG Moore Medical Cherry Cough Suppressant/Anesthetic Drops Menthol LOZENGE ORAL 20111101 OTC MONOGRAPH FINAL part341 Moore Medical LLC MENTHOL 7.6 mg/1 55670-080_83d18b69-90ec-4083-ad1e-eb625ce37ef1 55670-080 HUMAN OTC DRUG Moore Medical Sugar Free Black Cherry Cough Suppressant/Anesthetic Drops Menthol LOZENGE ORAL 20111101 OTC MONOGRAPH FINAL part341 Moore Medical LLC MENTHOL 5 mg/1 55670-109_718d1496-ae30-4c03-a34a-4eee4c90de50 55670-109 HUMAN OTC DRUG Moore Medical Sugar Free Menthol Cough Suppressant/Anesthetic Drops Menthol LOZENGE ORAL 20111101 OTC MONOGRAPH FINAL part341 Moore Medical LLC MENTHOL 5.8 mg/1 55670-112_b18d0cd7-2b0b-4eba-9649-521ebe7ba389 55670-112 HUMAN OTC DRUG Hand Sanitizer alcohol GEL TOPICAL 20120712 OTC MONOGRAPH NOT FINAL part333E Moore Medical LLC ALCOHOL 540.26 g/L 55670-122_5c6f54ff-9ae0-4426-a65a-2da9f898562e 55670-122 HUMAN OTC DRUG Moore Medical Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Moore Medical LLC ACETAMINOPHEN 325 mg/1 55670-130_86c5da63-1bbd-453a-b12d-2b77ccbc46bf 55670-130 HUMAN OTC DRUG Moore Medical Extra Strength Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Moore Medical LLC ACETAMINOPHEN 500 mg/1 55670-131_9d5be033-87dc-4d68-81e4-8cc79ba572c4 55670-131 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part343 Moore Medical LLC ASPIRIN 325 mg/1 55670-141_2dd20f88-5d5c-4db5-8e0b-e0fd717fbc3f 55670-141 HUMAN OTC DRUG Moore Medical Antacid calcium carbonate TABLET, CHEWABLE ORAL 20140711 OTC MONOGRAPH FINAL part331 Moore Medical LLC CALCIUM CARBONATE 420 mg/1 55670-142_462c1dac-be8d-4084-a642-d1f35f005a98 55670-142 HUMAN OTC DRUG Moore Medical Antacid calcium carbonate TABLET, CHEWABLE ORAL 20081230 OTC MONOGRAPH FINAL part331 Moore Medical LLC CALCIUM CARBONATE 420 mg/1 55670-143_78e1c98f-2df7-460a-9d8d-fefa872da203 55670-143 HUMAN OTC DRUG Moore Medical MooreBrand Severe Cold Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Moore Medical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 55670-150_6d51bf4b-e60f-4e35-a89d-3e78e7116c4b 55670-150 HUMAN OTC DRUG Moore Medical Sinus Pain and Pressure Relief ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Moore Medical LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 55670-163_d8d47951-dc22-4487-bb39-e2f80973841e 55670-163 HUMAN OTC DRUG MooreBrand Phenylephrine PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Moore Medical LLC PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 55670-467_f6aeaf18-fe96-41b9-8171-9b79b5bf00ec 55670-467 HUMAN OTC DRUG Moore Medical Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Moore Medical LLC ACETAMINOPHEN 325 mg/1 55670-468_94f51160-3def-421e-a890-0856c1e17c6e 55670-468 HUMAN OTC DRUG Moore Medical Extra Strength Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Moore Medical LLC ACETAMINOPHEN 500 mg/1 55670-471_b79991cc-1e9c-4073-ab1b-81c632906688 55670-471 HUMAN OTC DRUG Moore Medical LLC Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20081230 ANDA ANDA075139 Moore Medical LLC IBUPROFEN 200 mg/1 55670-473_07d364f3-b332-421b-e054-00144ff8d46c 55670-473 HUMAN OTC DRUG Moore Medical Bismuth BISMUTH SUBSALICYLATE TABLET, CHEWABLE ORAL 20081230 20170722 OTC MONOGRAPH FINAL part335 Moore Medical LLC BISMUTH SUBSALICYLATE 262 mg/1 55670-474_06f94a65-dff2-3b30-e054-00144ff88e88 55670-474 HUMAN OTC DRUG Moore Medical Bismuth BISMUTH SUBSALICYLATE TABLET, CHEWABLE ORAL 20140401 OTC MONOGRAPH FINAL part335 Moore Medical LLC BISMUTH SUBSALICYLATE 262 mg/1 55670-475_2faa1457-0ebe-41a4-88c9-b9177464b463 55670-475 HUMAN OTC DRUG Moore Medical Sinus Pain and Pressure Relief ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Moore Medical LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 55670-478_65c924ed-f629-41ca-8951-abd85e05ef51 55670-478 HUMAN OTC DRUG Moore Medical Loratadine Loratadine TABLET, FILM COATED ORAL 20081230 ANDA ANDA076134 Moore Medical LLC LORATADINE 10 mg/1 55670-600_ccad54de-01f8-4c14-a11b-c0f9c7c9fd8f 55670-600 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20120711 OTC MONOGRAPH FINAL part333B Moore Medical LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 55670-601_bb229f72-54e3-43e1-be72-d6e356103a0d 55670-601 HUMAN OTC DRUG Bacitracin bacitracin zinc OINTMENT TOPICAL 20120712 OTC MONOGRAPH FINAL part333B Moore Medical LLC BACITRACIN ZINC 500 [USP'U]/g 55670-602_1767e441-9017-480a-b660-e67b2e0e262d 55670-602 HUMAN OTC DRUG Antifungal tolnaftate CREAM TOPICAL 20120716 OTC MONOGRAPH FINAL part333C Moore Medical LLC TOLNAFTATE 10 mg/g 55670-675_462c1dac-be8d-4084-a642-d1f35f005a98 55670-675 HUMAN OTC DRUG Moore Medical Antacid calcium carbonate TABLET, CHEWABLE ORAL 20081230 OTC MONOGRAPH FINAL part331 Moore Medical LLC CALCIUM CARBONATE 420 mg/1 55670-711_d31cbdf1-26a6-4cbe-b0ce-c49aae9b65a2 55670-711 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20110907 OTC MONOGRAPH NOT FINAL part333E Moore Medical LLC BENZALKONIUM CHLORIDE 1.3 mL/L 55670-800_047e58dd-0fdf-40bd-a15b-926864e41ab5 55670-800 HUMAN OTC DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 20120712 OTC MONOGRAPH NOT FINAL part348 Moore Medical LLC HYDROCORTISONE 10 mg/g 55670-804_9cc64a11-6c3b-4e1b-bffe-e94c0f1b34ff 55670-804 HUMAN OTC DRUG Antimicrobial Hand TRICLOSAN SOAP TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333A Moore Medical LLC TRICLOSAN .375 mL/100mL 55670-806_f07d5faa-f9c2-4761-bb78-22e5a852a904 55670-806 HUMAN OTC DRUG Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333A Moore Medical LLC ALCOHOL 64.5 mL/100mL 55670-810_54952d9e-422d-47b9-a05d-c59b2cd4baaa 55670-810 HUMAN OTC DRUG Anesthetic benzocaine GEL TOPICAL 20120712 OTC MONOGRAPH NOT FINAL part356 Moore Medical LLC BENZOCAINE 200 mg/g 55670-815_88f7cfd9-0b60-4b7d-93e5-22eb66554254 55670-815 HUMAN OTC DRUG Moore Brand Unna Boot Zinc Oxide DRESSING TOPICAL 20130306 OTC MONOGRAPH FINAL part347 MOORE MEDICAL LLC ZINC OXIDE 25 g/1 55670-957_8eaf840d-71e1-41c8-b5e3-c14ecf434e7e 55670-957 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333A Moore Medical ISOPROPYL ALCOHOL .7 mL/1 55670-958_8eaf840d-71e1-41c8-b5e3-c14ecf434e7e 55670-958 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333A Moore Medical ISOPROPYL ALCOHOL .7 mL/1 55670-959_8eaf840d-71e1-41c8-b5e3-c14ecf434e7e 55670-959 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333A Moore Medical ISOPROPYL ALCOHOL .7 mL/1 55681-211_6109f544-68b8-42b5-b446-acf6fd5d7664 55681-211 HUMAN OTC DRUG procure PETROLATUM OINTMENT TOPICAL 20130205 OTC MONOGRAPH FINAL part347 TWIN MED, LLC PETROLATUM 1 g/g 55681-212_96c7a4b4-c858-4800-a1a5-d5380023fcde 55681-212 HUMAN OTC DRUG ProcureVITAMIN A AND D VITAMIN A AND D PETROLATUM OINTMENT TOPICAL 20130205 OTC MONOGRAPH FINAL part347 TWIN MED, LLC PETROLATUM 75 g/100g 55681-215_de28a530-cb62-4549-9387-03d0b49e642d 55681-215 HUMAN OTC DRUG PROCURE VITAMIN A AND D Skin Protectant petrolatum OINTMENT TOPICAL 20131206 OTC MONOGRAPH FINAL part347 TWIN MED, LLC PETROLATUM 93.4 g/100g 55681-216_2aa35162-15fd-41e6-982d-c6f08aa81fa0 55681-216 HUMAN OTC DRUG ProcureTriple Antibiotic Triple Antibiotic BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B OINTMENT TOPICAL 20130205 OTC MONOGRAPH FINAL part333B TWIN MED, LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 U/g; mg/g; U/g 55681-218_84b3894e-361a-431e-bb6e-ddded37420cf 55681-218 HUMAN OTC DRUG procureFirst Aid Antibio First Aid Antibiotic BACITRACIN OINTMENT TOPICAL 20130205 OTC MONOGRAPH FINAL part333B TWIN MED, LLC BACITRACIN ZINC 500 U/g 55681-224_26e2ef10-08e8-4c0d-adf7-d8c304caa1ad 55681-224 HUMAN OTC DRUG procure HYDROCORTISONE OINTMENT TOPICAL 20130205 OTC MONOGRAPH NOT FINAL part348 TWIN MED, LLC HYDROCORTISONE 1 g/100g 55692-100_ede7698b-a273-455a-b814-e0220e38a2d8 55692-100 HUMAN OTC DRUG BAROX BODY CARE MASSAGE Menthol GEL TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 Dr.JangLab Inc. MENTHOL 2.4 mg/120mL 55692-110_259b2383-1308-4d3e-9182-2d2ecd1c148f 55692-110 HUMAN OTC DRUG BAROX S CAMPHOR (SYNTHETIC), METHYL SALICYLATE, MENTHOL GEL TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part348 Dr.JangLab Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 7.08; .96; 5.52 g/120g; g/120g; g/120g 55692-200_4bbe2801-96b5-4f51-85e9-e133bfc266fe 55692-200 HUMAN OTC DRUG BAROX Body Care Massage Relax Refresh Revital Menthol GEL TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part348 Dr.JangLab Inc. MENTHOL 3 mg/120mL 55700-001_a60a910d-2c4a-4ac7-a314-a2e847f31969 55700-001 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Lake Erie Medical DBA Quality Care Products LLC BUSPIRONE HYDROCHLORIDE 5 mg/1 55700-002_8d6df5b4-124b-400d-a383-c6b26ec32669 55700-002 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20100804 ANDA ANDA090027 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55700-003_4455a725-3679-4253-92fe-e3c37aded6f4 55700-003 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20080801 ANDA ANDA076017 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 55700-004_1b9a704d-60fd-4dfd-a3ab-0246f3a5cd0d 55700-004 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 Lake Erie Medical DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 55700-005_d9823610-0d65-427e-9b73-6c21f7e4e032 55700-005 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20130522 ANDA ANDA040663 Lake Erie Medical DBA Quality Care Products LLC WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 55700-006_7aee951c-887a-4f7f-b2e0-b031aa385ea5 55700-006 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20090702 ANDA ANDA040907 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 55700-007_778c8440-82c5-4930-92c5-4299a9d3b497 55700-007 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 55700-008_9d0fb2f0-6f01-4775-a976-0c62de8c60ef 55700-008 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Lake Erie Medical DBA Quality Care Products LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55700-009_44def686-08ea-4eea-a4e0-f8c9566d643e 55700-009 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120112 ANDA ANDA062713 Lake Erie Medical DBA Quality Care Products LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 55700-010_413b4230-2b63-4949-8c54-c428b60d3652 55700-010 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Lake Erie Medical DBA Quality Care Products LLC LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 55700-011_4c852321-3758-4345-96e3-b09553fcddca 55700-011 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55700-012_4c852321-3758-4345-96e3-b09553fcddca 55700-012 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 55700-013_ec00a9e5-0b82-4a66-b093-90933871e9d5 55700-013 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Lake Erie Medical DBA Quality Care Products LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 55700-014_6e252a5b-64b5-4386-b3e3-25f5bd6fd77f 55700-014 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55700-015_d334cd35-d0c0-4a88-a161-0bdad95e155f 55700-015 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 55700-016_d7182e90-ff33-4e2b-9117-ac85388da165 55700-016 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111212 ANDA ANDA201384 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 55700-017_28572def-480b-40c0-81a6-cc6df48e3e94 55700-017 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20130618 ANDA ANDA078040 Lake Erie Medical DBA Quality Care Products LLC RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 55700-018_c5326aa6-d5cb-43bd-abdc-eae1a7ffb306 55700-018 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20091223 NDA NDA021515 Lake Erie Medical DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 55700-019_ee492778-396d-4f3a-81c7-cf31112081ff 55700-019 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20130410 ANDA ANDA090970 Lake Erie Medical DBA Quality Care Products LLC PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 55700-020_716966c9-7d7a-4917-8a59-e27976dd67bd 55700-020 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20121119 ANDA ANDA090659 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 55700-021_1a57d6e7-5e1d-4fe9-82fc-f3bdc289a621 55700-021 HUMAN PRESCRIPTION DRUG SIMVASTATIN Simvastatin TABLET, FILM COATED ORAL 20120329 ANDA ANDA077752 Lake Erie Medical DBA Quality Care Products LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 55700-022_220c5969-e8e2-4d68-b2b6-6bc5e63ffd77 55700-022 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031101 ANDA ANDA076467 Lake Erie Medical DBA Quality Care Products LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 55700-023_6e252a5b-64b5-4386-b3e3-25f5bd6fd77f 55700-023 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 55700-025_ccded700-044d-4f59-8899-27f309d49c05 55700-025 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine PATCH CUTANEOUS 20130915 ANDA ANDA200675 Lake Erie Medical DBA Quality Care Products LLC LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 55700-044_aad34606-173c-42c2-9e02-6555cd21dec6 55700-044 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062935 Lake Erie Medical DBA Quality Care Products LLC PENICILLIN V POTASSIUM 500 mg/1 55700-147_2904a2ad-4dc9-44c8-934e-39d97f23a116 55700-147 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride, naloxone hydrochloride FILM, SOLUBLE SUBLINGUAL 20100913 NDA NDA022410 Lake Erie Medical DBA Quality Care Products LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 55700-170_ffe177e3-4853-4ad3-bb43-4a5b6adb65ae 55700-170 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 55711-064_0089cee9-edf4-44ae-96a9-8209b9fb379b 55711-064 HUMAN OTC DRUG Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 10 mg/1 55711-064_2299916d-9864-4176-bc77-fa35a0ed959b 55711-064 HUMAN OTC DRUG Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100908 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 10 mg/1 55711-064_2b1c6c4e-6737-42e4-be82-db5795f3b7f5 55711-064 HUMAN OTC DRUG Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 10 mg/1 55711-064_acbcbc4e-e0dc-45ba-9323-680d4004adea 55711-064 HUMAN OTC DRUG Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 10 mg/1 55711-064_d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf 55711-064 HUMAN OTC DRUG Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 10 mg/1 55711-066_065ef0a6-3490-4a72-80e2-dea7ac1d8c89 55711-066 HUMAN OTC DRUG Sugar Free Refreshing Mint Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 3 mg/1 55711-066_d7c709ed-41fb-4854-b251-f1ebc7c07a78 55711-066 HUMAN OTC DRUG Sugar Free Refreshing Mint Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 3 mg/1 55711-066_f70cfec6-be1f-412a-a8d6-61675e3685d9 55711-066 HUMAN OTC DRUG Sugar Free Refreshing Mint Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 3 mg/1 55711-069_0213ac54-3a68-44b6-b0ef-d603c4a09ba8 55711-069 HUMAN OTC DRUG Low Sugar Cherry Flavor Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 5.75 mg/1 55711-069_12dc2ff7-395f-4e47-82b8-3df48db071f0 55711-069 HUMAN OTC DRUG Low Sugar Cherry Flavor Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 5.75 mg/1 55711-069_27b1977b-ba86-47aa-976d-c5769a7e4b39 55711-069 HUMAN OTC DRUG Low Sugar Cherry Flavor Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100908 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 5.75 mg/1 55711-069_d636d793-1b40-438a-a768-d66be5fff4af 55711-069 HUMAN OTC DRUG Low Sugar Cherry Flavor Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 5.75 mg/1 55711-070_3bfa1bb6-47e0-4931-a0c9-fe5a8c9d57da 55711-070 HUMAN OTC DRUG Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 6.9 mg/1 55711-070_42d4bafb-b630-487e-b63d-13ad37a59454 55711-070 HUMAN OTC DRUG Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 6.9 mg/1 55711-070_71503407-0eb6-4901-9f04-40c9a9e9f788 55711-070 HUMAN OTC DRUG Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 6.9 mg/1 55714-1101_66b237e3-a29b-9415-d2db-0c8a57300d00 55714-1101 HUMAN OTC DRUG Prime Plus Agnus, Allium sativum, Ambra, Angelica sinensis radix, Aralia quinquefolia, Arnica, Arsenicum alb., Avena, Baptisia, Baryta carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux vom., Phosphoricum ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. met., Ginkgo, Ruta, Organic, Cane Dispensing Alcohol LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMBERGRIS; AMERICAN GINSENG; ANGELICA SINENSIS ROOT; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; CHASTE TREE; GARLIC; GINKGO; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; STRYCHNOS NUX-VOMICA SEED; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1102_f91a0168-92d4-e0c9-e015-ab05177c3133 55714-1102 HUMAN OTC DRUG Sick Stopper Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo rana, Aconitum nap., Agaricus musc., Aralia quinquefolia, Baptisia, Bryonia, Chelidonium majus, Eupatorium perf., Hepar sulph. calc., Lachesis, Lycopodium, Nux vom., Rhus toxicodendron, Sanguinaria, Sulphur, Thuja occ., Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; BUFO BUFO CUTANEOUS GLAND; CALCIUM SULFIDE; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; RANCID BEEF; SANGUINARIA CANADENSIS ROOT; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 30; 10; 10; 15; 10; 10; 3; 10; 30; 30; 10; 10; 30; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1103_b62c5e84-5cbe-1a94-31a5-40c249953525 55714-1103 HUMAN OTC DRUG Swimmers Support Antimon. tart., Arnica, Bellis, Bryonia, Calc. carb., Capsicum, Chelidonium majus, Cuprum met., Digitalis, Drosera, Lachesis, Lacticum acidum, Ledum, Mag. carb., Mang. acet., Nux vom., Phytolacca, Rhus toxicodendron, Ruta, Sarcolacticum ac., Sulphuricum ac., Verbascum, Vipera berus LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LACTIC ACID, L-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFURIC ACID; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS; VIPERA BERUS VENOM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1104_926fe9a7-caf2-0995-feb7-f74730131779 55714-1104 HUMAN OTC DRUG Hangover Help Agaricus musc., Arsenicum alb., Bismuthum metallicum, Bryonia, Capsicum, Carbo veg., Glonoinum, Ipecac., Iris versicolor, Laurocerasus, Lycopodium, Mezereum, Nux vom., Pulsatilla, Ranunc. bulb. , Theridion, Veratrum alb., Zinc. met., Zingiber, Chamomilla, Passiflora, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; DAPHNE MEZEREUM BARK; GINGER; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; NITROGLYCERIN; PASSIFLORA INCARNATA FLOWERING TOP; PRUNUS LAUROCERASUS LEAF; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM; VALERIAN; VERATRUM ALBUM ROOT; ZINC 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 3; 15; 15; 15; 15; 15; 3; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1105_a36044af-cc69-5ca4-22d0-2f284b542ab0 55714-1105 HUMAN OTC DRUG Prime Plus Agnus, Allium sativum, Ambra, Angelica sinensis radix, Aralia quinquefolia, Arnica, Arsenicum alb., Avena, Baptisia, Baryta carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux vom., Phosphoricum ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. met., Ginkgo PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMBERGRIS; AMERICAN GINSENG; ANGELICA SINENSIS ROOT; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; CHASTE TREE; GARLIC; GINKGO; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; STRYCHNOS NUX-VOMICA SEED; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1106_8f0ca02f-b9be-d943-7aeb-4366fc18a0fa 55714-1106 HUMAN OTC DRUG Panic Button Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus canadensis, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus spin., Rhus toxicodendron, Sarcolacticum ac., Sulphur, Veratrum alb., Valeriana. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; DAPHNE MEZEREUM BARK; FERROSOFERRIC PHOSPHATE; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; LACTIC ACID, L-; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; STRYCHNOS IGNATII SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; VALERIAN; VERATRUM ALBUM ROOT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1107_32c0ee63-a825-b1ed-ac05-aae1b5fae586 55714-1107 HUMAN OTC DRUG Sports Injury Apis mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum acidum, Ledum, Phosphorus, Rhus toxicodendron, Ruta, Sarcolacticum ac., Staphysag., Symphytum, Echinacea, Hydrastis LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CINCHONA OFFICINALIS BARK; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LACTIC ACID, L-; LEDUM PALUSTRE TWIG; MATRICARIA RECUTITA; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1110_e274f180-6d99-2f22-c3a4-be23bc4eb1c0 55714-1110 HUMAN OTC DRUG Jet Lag Alumina, Aralia quinquefolia, Arg. nit., Arnica, Arsenicum alb., Baptisia, Bryonia, Cantharis, Chelidonium majus, Conium, Gelsemium, Iodium, Kali carb., Kali iod., Lycopodium, Lycopus virginicus, Nat. mur., Nux vom., Phosphorus, Phytolacca, Pulsatilla, Rhus toxicodendron, Sabal, Thyroidinum, Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALUMINUM OXIDE; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; IODINE; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; LYTTA VESICATORIA; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; SAW PALMETTO; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1112_ffdf8089-948d-f550-63b0-d126f5fb7f40 55714-1112 HUMAN OTC DRUG Swimmers Support Antimon. tart., Arnica, Bellis, Bryonia, Calc. carb., Capsicum, Chelidonium majus, Cuprum met., Digitalis, Drosera, Lachesis, Lacticum acidum, Ledum, Mag. carb., Mang. acet., Nux vom., Phytolacca, Rhus toxicodendron, Ruta, Sarcolacticum ac., Sulphuricum ac., Verbascum, Vipera berus PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LACTIC ACID, L-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFURIC ACID; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS; VIPERA BERUS VENOM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1113_b827d6f1-fec2-b79d-c929-be2b7dd29a18 55714-1113 HUMAN OTC DRUG Hangover Help Agaricus musc., Arsenicum alb., Bismuthum metallicum, Bryonia, Capsicum, Carbo veg., Glonoinum, Ipecac., Iris versicolor, Laurocerasus, Lycopodium, Mezereum, Nux vom., Pulsatilla, Ranunc. bulb. , Theridion, Veratrum alb., Zinc. met., Zingiber, Chamomilla, Passiflora, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; DAPHNE MEZEREUM BARK; GINGER; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; NITROGLYCERIN; PASSIFLORA INCARNATA FLOWERING TOP; PRUNUS LAUROCERASUS LEAF; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM; VALERIAN; VERATRUM ALBUM ROOT; ZINC 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 3; 15; 15; 15; 15; 15; 3; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1114_74cca58d-d073-b3ce-1474-e3fe6cf1a8e4 55714-1114 HUMAN OTC DRUG Sick Stopper Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo rana, Aconitum nap., Agaricus musc., Aralia quinquefolia, Baptisia, Bryonia, Chelidonium majus, Eupatorium perf., Hepar sulph. calc., Lachesis, Lycopodium, Nux vom., Rhus toxicodendron, Sanguinaria, Sulphur, Thuja occ., Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; BUFO BUFO CUTANEOUS GLAND; CALCIUM SULFIDE; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; RANCID BEEF; SANGUINARIA CANADENSIS ROOT; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 30; 10; 10; 15; 10; 10; 3; 10; 30; 30; 10; 10; 30; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1115_dde3fa0b-5ce4-1b03-4d8f-5d1901ba6755 55714-1115 HUMAN OTC DRUG Panic Button Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus canadensis, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus spin., Rhus toxicodendron, Sarcolacticum ac., Sulphur, Veratrum alb., Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; DAPHNE MEZEREUM BARK; FERROSOFERRIC PHOSPHATE; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; LACTIC ACID, L-; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; STRYCHNOS IGNATII SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; VALERIAN; VERATRUM ALBUM ROOT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1116_eb0fbe4e-d982-a33e-489e-2ca0f8beec9a 55714-1116 HUMAN OTC DRUG Sports Injury Apis mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum acidum, Ledum, Phosphorus, Rhus toxicodendron, Ruta, Sarcolacticum ac., Staphysag., Symphytum, Echinacea, Hydrastis PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CINCHONA OFFICINALIS BARK; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LACTIC ACID, L-; LEDUM PALUSTRE TWIG; MATRICARIA RECUTITA; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1118_b8a8592d-20d3-a64d-5ffb-b37e9d175059 55714-1118 HUMAN OTC DRUG Jet Lag Alumina, Aralia quinquefolia, Arg. nit., Arnica, Arsenicum alb., Baptisia, Bryonia, Cantharis, Chelidonium majus, Conium, Gelsemium, Iodium, Kali carb., Kali iod., Lycopodium, Lycopus virginicus, Nat. mur., Nux vom., Phosphorus, Phytolacca, Pulsatilla, Rhus toxicodendron, Sabal, Thyroidinum, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALUMINUM OXIDE; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; IODINE; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; LYTTA VESICATORIA; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; SAW PALMETTO; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_M]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1500_cb44a5da-f618-339c-d74e-c2c2062e8ff2 55714-1500 HUMAN OTC DRUG Detoxifier Uricum acidum, Benzoicum acidum, Berber. vulg., Bryonia, Cantharis, Carduus benedictus, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Dioscorea, Dolichos, Iris versicolor, Juniperus com., Nux vom., Ptelea, Taraxacum, Carduus mar., Cynara scolymus, Solidago LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; DIOSCOREA VILLOSA TUBER; IRIS VERSICOLOR ROOT; JUNIPER BERRY; LYTTA VESICATORIA; MUCUNA PRURIENS FRUIT TRICHOME; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; URIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 3; 3; 10; 10; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1501_dea94df5-2331-fde2-75d6-d3527447b625 55714-1501 HUMAN OTC DRUG Asthma Rescue - Cough Influenzinum, Antimon. tart., Arsenicum alb., Bryonia, Chelidonium majus, Cinchona, Drosera, Eucalyptus, Histaminum hydrochloricum, Hydrastis, Kali bic., Kali carb., Kali iod., Myrrha, Nat. sulphuricum, Nux vom., Phosphorus, Pulsatilla, Rumex crisp., Sambucus nig., Spongia, Tussilago farfara, Verbascum, Echinacea, Lappa. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY POTASSIUM TARTRATE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA FLOWERING TOP; ECHINACEA, UNSPECIFIED; EUCALYPTUS GLOBULUS LEAF; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; MYRRH; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS NUX-VOMICA SEED; TUSSILAGO FARFARA; VERBASCUM THAPSUS 15; 3; 15; 15; 15; 15; 15; 3; 15; 15; 15; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1502_6f872ed1-6f81-421e-8843-0ca9aee6c2e7 55714-1502 HUMAN OTC DRUG Sniffles Influenzinum, Aconitum nap., Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procumbens, Gelsemium, Histaminum hydrochloricum, Hydrastis, Kali bic., Lycopodium, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Salvia, Sticta, Thuja occ., Verbascum, Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LOBARIA PULMONARIA; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SAGE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1503_a99f90e9-d3f8-8fa3-65f8-d531448a33aa 55714-1503 HUMAN OTC DRUG Fever Infection Influenzinum, Aconitum nap., Arsenicum alb., Belladonna, Bryonia, Camphora, Cina, Cinchona, Eupatorium perf., Ferrum phosphoricum, Gelsemium, Hepar sulph. calc., Ignatia, Nat. mur., Nux vom., Phosphorus, Pulsatilla, Salix nigra,Veratrum viride, Chamomilla, Echinacea, Hydrastis. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ARTEMISIA CINA PRE-FLOWERING TOP; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; MATRICARIA RECUTITA; PHOSPHORUS; PULSATILLA VULGARIS; SALIX NIGRA BARK; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; VERATRUM VIRIDE ROOT 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 3; 30; 30; 3; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1504_db4d230c-b4a2-f034-298d-5d16f5c64935 55714-1504 HUMAN OTC DRUG Ear Care Influenzinum, Tellurium metallicum, Apis mel., Arsenicum alb., Belladonna, Bryonia, Capsicum, austicum, Cinchona, Conium,Dulcamara, Ferrum phosphoricum, Hepar sulph. calc.,Kali sulph., ycopodium, Merc. viv., Mezereum,Phosphorus, Plantago, Pulsatilla, Silicea,Verbascum, Echinacea, Hydrastis LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORUS; PLANTAGO MAJOR; POTASSIUM SULFATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; TELLURIUM; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 3; 30; 30; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1505_577e4bf2-48a3-16fc-e6dc-33d80a5aecb6 55714-1505 HUMAN OTC DRUG Constipation Abies nig., Aesculus hipp., Aloe, Alumina, Bryonia, Carbo veg., Chelidonium majus, Collinsonia, Graphites, Hydrastis, Kali carb., Lycopodium, Mag. mur., Mezereum, Nux vom., Podoph. pelt., Rhamnus purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum alb., Zinc. met., Echinacea, Iris versicolor, Phytolacca, Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; FRANGULA PURSHIANA BARK; GOLDENSEAL; GRAPHITE; HORSE CHESTNUT; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; PHYTOLACCA AMERICANA ROOT; PICEA MARIANA RESIN; PODOPHYLLUM; POTASSIUM CARBONATE; SANICULA EUROPAEA LEAF; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TOBACCO LEAF; VERATRUM ALBUM ROOT; ZINC 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1506_12bdabc8-66da-ae87-c873-826c5ab46bd6 55714-1506 HUMAN OTC DRUG Allergies Cow milk, Skim milk, Cow milk fat, Casein Lactococcus Lactis cultured, Casein lactococcus lactis penicilium roqueforti cultured, Casein lactococcus lactis cultured penicillium camemberti cultured, Egg, Felis catus skin, Canis lupus familiaris skin, Orysctolagus cuniculus skin, Equus caballus skin, Serinus canaria feather, gallus gallus feather, Anas platyrhynchos feather, Anser anser feather, melopsittacus undulatus feather, Phasianus colchicus feather, Meleagris gallopavo feather, Felis catus hair LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. 2-PHENYLPHENOL; ABRUS PRECATORIUS SEED; ACID GREEN 50; ACID RED 1; ACONITUM NAPELLUS; AETHUSA CYNAPIUM; AGROSTIS GIGANTEA POLLEN; ALETRIS FARINOSA ROOT; ALFALFA; ALLYLTHIOUREA; ALOPECURUS PRATENSIS POLLEN; ALPINE STRAWBERRY; AMANITA MUSCARIA FRUITING BODY; AMARANTH; AMBROSIA ARTEMISIIFOLIA; ANACARDIUM OCCIDENTALE FRUIT; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ANTHOXANTHUM ODORATUM POLLEN; APIS MELLIFERA; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; ARUNDO PLINIANA ROOT; ASCORBIC ACID; ASPARTAME; ASPERGILLUS NIGER VAR. NIGER; ATROPA BELLADONNA; AVENA SATIVA POLLEN; BARLEY; BEEF; BELLIS PERENNIS; BETULA PENDULA POLLEN; BLACK MUSTARD SEED; BOS TAURUS HAIR; BRAZIL NUT; BROMINE; BROMUS SECALINUS POLLEN; BRYONIA ALBA ROOT; CAFFEINE; CALLUNA VULGARIS POLLEN; CANIS LUPUS FAMILIARIS HAIR; CAPRA HIRCUS HAIR; CAPSICUM; CARMOISINE; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CAVIA PORCELLUS HAIR; CHELIDONIUM MAJUS; CHICKEN; CINNAMON; CLADOSPORIUM HERBARUM; COD, UNSPECIFIED; CORN; CORYLUS AMERICANA POLLEN; COW MILK; COW MILK FAT; CRAB LEG, UNSPECIFIED; CRATAEGUS MONOGYNA POLLEN; CYNARA SCOLYMUS LEAF; CYNOSURUS CRISTATUS POLLEN; CYTISUS SCOPARIUS POLLEN; D&C YELLOW NO. 10; DATURA STRAMONIUM; DIANTHUS CARYOPHYLLUS FLOWER; DROSERA ROTUNDIFOLIA; DYSPHANIA AMBROSIOIDES; ECHINACEA, UNSPECIFIED; ECHINOCHLOA CRUS-GALLI POLLEN; EGG; ELYMUS REPENS ROOT; ENGLISH WALNUT; EQUUS CABALLUS HAIR; EQUUS CABALLUS SKIN; EUPHRASIA STRICTA; FAGUS SYLVATICA POLLEN; FD&C BLUE NO. 2; FD&C RED NO. 3; FD&C YELLOW NO. 5; FD&C YELLOW NO. 6; FELIS CATUS HAIR; FELIS CATUS SKIN; FESTUCA PRATENSIS POLLEN; FRAXINUS EXCELSIOR POLLEN; GALLUS GALLUS FEATHER; GARLIC; GELSEMIUM SEMPERVIRENS ROOT; GINGER; GLYCYRRHIZA GLABRA; GOLDENSEAL; HADDOCK; HAZELNUT, UNSPECIFIED; HELIANTHEMUM CANADENSE; HERRING, UNSPECIFIED; HISTAMINE DIHYDROCHLORIDE; HOLCUS LANATUS POLLEN; HOUSE DUST; HUMAN DANDER; HUMAN HAIR; HUMAN SKIN; HYOSCYAMUS NIGER; JUNIPERUS VIRGINIANA TWIG; LACTOSE; LAMB; LEDUM PALUSTRE TWIG; LILIUM CANDIDUM FLOWER; LOLIUM PERENNE POLLEN; LYCOPERDON UTRIFORME FRUITING BODY; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; MATRICARIA RECUTITA; MELEAGRIS GALLOPAVO FEATHER; MELOPSITTACUS UNDULATUS FEATHER; MENTHA PIPERITA; MESOCRICETUS AURATUS HAIR; MONOSODIUM GLUTAMATE; NARCISSUS PSEUDONARCISSUS; NUTMEG; OAT; ONION; ONOSMODIUM VIRGINIANUM WHOLE; ORYCTOLAGUS CUNICULUS HAIR; ORYCTOLAGUS CUNICULUS SKIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; OYSTER, UNSPECIFIED; PEANUT; PHASIANUS COLCHICUS FEATHER; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PLATANUS ORIENTALIS POLLEN; POA PRATENSIS POLLEN; PONCEAU 4R; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; PORK; POTASSIUM BENZOATE; POTASSIUM IODIDE; PRIMULA VULGARIS; PROPYLPARABEN; PTELEA TRIFOLIATA BARK; PULSATILLA VULGARIS; QUAHOG, UNSPECIFIED; QUERCUS ALBA POLLEN; ROSA CANINA FLOWER; RYE; SACCHARIN; SACCHAROMYCES CEREVISIAE; SALIX ALBA POLLEN; SALMON, UNSPECIFIED; SAMBUCUS NIGRA FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; SCALLOP, UNSPECIFIED; SCHOENOCAULON OFFICINALE SEED; SERINUS CANARIA FEATHER; SHEEP WOOL; SHRIMP, UNSPECIFIED; SKIM MILK; SODIUM BENZOATE; SODIUM CHLORIDE; SODIUM COPPER CHLOROPHYLLIN; SODIUM DITHIONATE; SODIUM NITRITE; SODIUM TRIPOLYPHOSPHATE; SOLANUM DULCAMARA TOP; SOLANUM LYCOPERSICUM; SOLANUM NIGRUM WHOLE; SOLANUM TUBEROSUM; SUCROSE; SULFUR; TARAXACUM OFFICINALE; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; TRILLIUM ERECTUM ROOT; TROUT, UNSPECIFIED; TUNA, UNSPECIFIED; TURKEY; ULEX EUROPAEUS FLOWER; ULMUS GLABRA POLLEN; URTICA URENS; USTILAGO MAYDIS; WHEAT; WHEAT GLUTEN; WHITE RICE; WYETHIA HELENIOIDES ROOT; XEROPHYLLUM ASPHODELOIDES; YUCCA FILAMENTOSA 60; 15; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 15; 60; 15; 15; 60; 60; 15; 3; 15; 15; 15; 60; 60; 15; 15; 15; 60; 60; 15; 15; 15; 60; 15; 15; 15; 15; 15; 15; 60; 60; 15; 60; 60; 60; 60; 60; 15; 60; 15; 15; 15; 60; 15; 60; 60; 60; 15; 15; 15; 15; 60; 15; 15; 15; 15; 3; 15; 60; 15; 15; 60; 60; 15; 15; 60; 60; 60; 60; 60; 60; 15; 15; 60; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 60; 60; 60; 15; 15; 15; 60; 15; 15; 15; 15; 15; 15; 15; 60; 60; 15; 60; 60; 15; 15; 60; 15; 15; 60; 60; 15; 60; 15; 60; 15; 15; 15; 15; 60; 15; 15; 15; 60; 60; 15; 15; 60; 15; 15; 60; 15; 15; 60; 15; 15; 15; 15; 15; 15; 60; 15; 60; 60; 60; 60; 60; 15; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 60; 15; 15; 15; 15; 60; 60; 60; 15; 30; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1508_13bd63e7-32cd-b272-1e7c-3fe49c04fa45 55714-1508 HUMAN OTC DRUG Tummy Upset Bismuthum metallicum, Aloe, Angelica sinensis radix, Antimon. crud., Arg. nit., Arnica, Arsenicum alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. carb., Nux vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris versicolor, Ruta, Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; ANGELICA SINENSIS ROOT; ANTIMONY TRISULFIDE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; GINGER; GOLDENSEAL; GRAPHITE; IPECAC; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; MYRRH; PHOSPHORUS; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 15; 10; 10; 3; 10; 10; 10; 10; 3; 10; 10; 3; 10; 10; 10; 3; 10; 10; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1509_eb10e98e-a6c0-5815-f9ab-fb5b366db85b 55714-1509 HUMAN OTC DRUG Teething - Colic Aconitum nap., Apis mel., Baptisia, Belladonna, Borax, Bryonia, Calc. carb., Calc. phos., Chamomilla, Chelidonium majus, Coffea cruda, Collinsonia, Colocynthis, Kreosotum, Mag.phos., Nux vom., Podoph. pelt., Rheum, Scutellarialateriflora, Silicea, Terebinthina, Zingiber, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARABICA COFFEE BEAN; ATROPA BELLADONNA; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; COLLINSONIA CANADENSIS ROOT; GINGER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PODOPHYLLUM; RHEUM OFFICINALE ROOT; SCUTELLARIA LATERIFLORA; SILICON DIOXIDE; SODIUM BORATE; STRYCHNOS NUX-VOMICA SEED; TRIBASIC CALCIUM PHOSPHATE; TURPENTINE OIL; VALERIAN; WOOD CREOSOTE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1511_e59064e0-9029-05c9-5a1c-9dd351c83670 55714-1511 HUMAN OTC DRUG Diarrhea Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Carbo veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris versicolor, Lycopodium, Mag. carb., Phosphorus, Podoph. pelt., Rheum, Sulphur, Tabacum, Vaccinium, Aesculus hipp. Juglans regia, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BILBERRY; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COLLINSONIA CANADENSIS ROOT; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; HORSE CHESTNUT; IPECAC; IRIS VERSICOLOR ROOT; JUGLANS REGIA WHOLE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; PHOSPHORUS; PODOPHYLLUM; RHEUM OFFICINALE WHOLE; SILVER NITRATE; SULFUR; TOBACCO LEAF; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1512_0d6cb12f-e6d8-ff12-7cd7-dd541ac99218 55714-1512 HUMAN OTC DRUG Bangs Scrapes Aconitum nap., Arnica, Bellis, Calendula, Echinacea, Gelsemium, Hamamelis, Hypericum, Ledum, Phosphorus, Rhus toxicodendron, Ruta, Staphysag., Symphytum, Hydrastis LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1513_3f5f4fa9-1125-a5dd-d7c5-69c91fa184fe 55714-1513 HUMAN OTC DRUG Bedwetting Belladonna, Cantharis, Causticum, Equisetum hyemale, Ferrum metallicum, Gelsemium, Humulus, Kali phos., Lycopodium, Nat.mur., Plantago, Pulsatilla, Rhus aromatica, Sabal, Thyroidinum, Verbascum, Echinacea, Hydrastis, Passiflora, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ATROPA BELLADONNA; CAUSTICUM; ECHINACEA, UNSPECIFIED; EQUISETUM HYEMALE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HOPS; IRON; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PASSIFLORA INCARNATA FLOWERING TOP; PLANTAGO MAJOR; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; RHUS AROMATICA ROOT BARK; SAW PALMETTO; SODIUM CHLORIDE; THYROID, UNSPECIFIED; VALERIAN; VERBASCUM THAPSUS 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1514_d8fec694-b6b1-555c-f73d-4e8f0408b13d 55714-1514 HUMAN OTC DRUG Hypercalm - Mental Focus Adrenalinum, Tarentula cubensis, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Chamomilla, Coffea cruda, Cypripedium, Digitalis, Gelsemium, Humulus, Hyoscyamus, Ignatia, Impatiens glandulifera flos, Iodium, Lachesis, Lycopodium, Nat. mur., Nux vom., Scutellaria lateriflora, Staphysag., Stramonium, Theridion, Veratrum viride, Echinacea, Hypericum, Passiflora LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; CITHARACANTHUS SPINICRUS; CYPRIPEDIUM PARVIFOLUM ROOT; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; DIGITALIS; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GELSEMIUM SEMPERVIRENS ROOT; HOPS; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM; VERATRUM VIRIDE ROOT 10; 10; 10; 10; 15; 10; 10; 10; 10; 3; 15; 10; 10; 10; 3; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1515_f2459605-6374-9304-3f40-987a7fec0761 55714-1515 HUMAN OTC DRUG Vaccination Illness Assist Influenzinum, Morbillinum, Pertussinum, Aconitum nap., Alumina, Antimon. tart., Arsenicum alb., Baptisia, Belladonna, Bryonia, Cinchona, Crotalus horridus, Gelsemium, Kali bic., Lachesis, Ledum, Merc. viv., Mezereum, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Silicea, Sulphur, Thuja occ., Vaccinium, Apis mel., Echinacea, Hypericum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALUMINUM OXIDE; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BILBERRY; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; HYPERICUM PERFORATUM; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; MEASLES VIRUS; MERCURY; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 30; 3; 30; 30; 10; 10; 30; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1516_811f7fc0-0dd1-d819-d502-6986772aaafc 55714-1516 HUMAN OTC DRUG Bowel Digestive Care Bismuthum metallicum, Antimon.crud., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Chamomilla, Cinchona, Iris versicolor, Kali bic., Lachesis, Lycopodium, Mag. carb., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Raphanus, Rhus toxicodendron, Tabacum, Verbascum, Zingiber, Echinacea, Juglans regia LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; DAIKON; ECHINACEA, UNSPECIFIED; GINGER; IRIS VERSICOLOR ROOT; JUGLANS REGIA LEAF; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; PHOSPHORUS; PODOPHYLLUM; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 10; 10; 10; 15; 10; 10; 10; 3; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-1700_b09e73ad-b019-a255-545d-a1240fd8394c 55714-1700 HUMAN OTC DRUG Detoxifier Uricum acidum, Benzoicum acidum, Berber. vulg., Bryonia, Cantharis, Carduus benedictus, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Dioscorea, Dolichos, Iris versicolor, Juniperus com., Nux vom., Ptelea, Taraxacum, Carduus mar., Cynara scolymus, Solidago PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; DIOSCOREA VILLOSA TUBER; IRIS VERSICOLOR ROOT; JUNIPER BERRY; LYTTA VESICATORIA; MUCUNA PRURIENS FRUIT TRICHOME; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; URIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 3; 3; 10; 10; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1701_3f14ad4c-4e5c-72dc-fb94-4b93880910fd 55714-1701 HUMAN OTC DRUG Asthma Rescue - Cough Influenzinum, Antimon. tart., Arsenicum alb., Bryonia, Chelidonium majus, Cinchona, Drosera, Eucalyptus, Histaminum hydrochloricum, Hydrastis, Kali bic., Kali carb., Kali iod., Myrrha, Nat. sulphuricum, Nux vom., Phosphorus, Pulsatilla, Rumex crisp., Sambucus nig., Spongia, Tussilago farfara, Verbascum, Echinacea, Lappa. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY POTASSIUM TARTRATE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA FLOWERING TOP; ECHINACEA, UNSPECIFIED; EUCALYPTUS GLOBULUS LEAF; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; MYRRH; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS NUX-VOMICA SEED; TUSSILAGO FARFARA; VERBASCUM THAPSUS 15; 3; 15; 15; 15; 15; 15; 3; 15; 15; 15; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1702_21ef99ec-5154-0951-5d6f-3c02dbcb3932 55714-1702 HUMAN OTC DRUG Sniffles Influenzinum, Aconitum nap., Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procumbens, Gelsemium, Histaminum hydrochloricum, Hydrastis, Kali bic., Lycopodium, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Salvia, Sticta, Thuja occ., Verbascum, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LOBARIA PULMONARIA; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SAGE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1703_727785e6-1e8e-102b-c648-7f20cd14759c 55714-1703 HUMAN OTC DRUG Fever Infection Influenzinum, Aconitum nap., Arsenicum alb., Belladonna, Bryonia, Camphora, Cina, Cinchona, Eupatorium perf., Ferrum phosphoricum, Gelsemium, Hepar sulph. calc., Ignatia, Nat. mur., Nux vom., Phosphorus, Pulsatilla, Salix nigra,Veratrum viride, Chamomilla, Echinacea, Hydrastis. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ARTEMISIA CINA PRE-FLOWERING TOP; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; MATRICARIA RECUTITA; PHOSPHORUS; PULSATILLA VULGARIS; SALIX NIGRA BARK; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; VERATRUM VIRIDE ROOT 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 3; 30; 30; 3; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1704_7250cac6-2d4e-0785-c5ff-3ce7cc21a4e0 55714-1704 HUMAN OTC DRUG Ear Care Influenzinum, Tellurium metallicum, Apis mel., Arsenicum alb., Belladonna, Bryonia, Capsicum, austicum, Cinchona, Conium,Dulcamara, Ferrum phosphoricum, Hepar sulph. calc.,Kali sulph., ycopodium, Merc. viv., Mezereum,Phosphorus, Plantago, Pulsatilla, Silicea,Verbascum, Echinacea, Hydrastis PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORUS; PLANTAGO MAJOR; POTASSIUM SULFATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; TELLURIUM; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 3; 30; 30; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1705_95d693a8-616b-557b-ed62-e4f99048c4f4 55714-1705 HUMAN OTC DRUG Constipation Abies nig., Aesculus hipp., Aloe, Alumina, Bryonia, Carbo veg., Chelidonium majus, Collinsonia, Graphites, Hydrastis, Kali carb., Lycopodium, Mag. mur., Mezereum, Nux vom., Podoph. pelt., Rhamnus purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum alb., Zinc. met., Echinacea, Iris versicolor, Phytolacca, Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; FRANGULA PURSHIANA BARK; GOLDENSEAL; GRAPHITE; HORSE CHESTNUT; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; PHYTOLACCA AMERICANA ROOT; PICEA MARIANA RESIN; PODOPHYLLUM; POTASSIUM CARBONATE; SANICULA EUROPAEA LEAF; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TOBACCO LEAF; VERATRUM ALBUM ROOT; ZINC 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1706_7658fa09-5173-8030-c990-f011fa889a22 55714-1706 HUMAN OTC DRUG Allergies Cow milk, Skim milk, Cow milk fat, Casein Lactococcus Lactis cultured, Casein lactococcus lactis penicilium roqueforti cultured, Casein lactococcus lactis cultured penicillium camemberti cultured, Egg, Felis catus skin, Canis lupus familiaris skin, Orysctolagus cuniculus skin, Equus caballus skin, Serinus canaria feather, gallus gallus feather, Anas platyrhynchos feather, Anser anser feather, melopsittacus undulatus feather, Phasianus colchicus feather, Meleagris gallopavo feather, Felis catus hair PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. 2-PHENYLPHENOL; ABRUS PRECATORIUS SEED; ACID GREEN 50; ACID RED 1; ACONITUM NAPELLUS; AETHUSA CYNAPIUM; AGROSTIS GIGANTEA POLLEN; ALETRIS FARINOSA ROOT; ALFALFA; ALLYLTHIOUREA; ALOPECURUS PRATENSIS POLLEN; ALPINE STRAWBERRY; AMANITA MUSCARIA FRUITING BODY; AMARANTH; AMBROSIA ARTEMISIIFOLIA; ANACARDIUM OCCIDENTALE FRUIT; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ANTHOXANTHUM ODORATUM POLLEN; APIS MELLIFERA; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; ARUNDO PLINIANA ROOT; ASCORBIC ACID; ASPARTAME; ASPERGILLUS NIGER VAR. NIGER; ATROPA BELLADONNA; AVENA SATIVA POLLEN; BARLEY; BEEF; BELLIS PERENNIS; BETULA PENDULA POLLEN; BLACK MUSTARD SEED; BOS TAURUS HAIR; BRAZIL NUT; BROMINE; BROMUS SECALINUS POLLEN; BRYONIA ALBA ROOT; CAFFEINE; CALLUNA VULGARIS POLLEN; CANIS LUPUS FAMILIARIS HAIR; CAPRA HIRCUS HAIR; CAPSICUM; CARMOISINE; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CAVIA PORCELLUS HAIR; CHELIDONIUM MAJUS; CHICKEN; CINNAMON; CLADOSPORIUM HERBARUM; COD, UNSPECIFIED; CORN; CORYLUS AMERICANA POLLEN; COW MILK; COW MILK FAT; CRAB LEG, UNSPECIFIED; CRATAEGUS MONOGYNA POLLEN; CYNARA SCOLYMUS LEAF; CYNOSURUS CRISTATUS POLLEN; CYTISUS SCOPARIUS POLLEN; D&C YELLOW NO. 10; DATURA STRAMONIUM; DIANTHUS CARYOPHYLLUS FLOWER; DROSERA ROTUNDIFOLIA; DYSPHANIA AMBROSIOIDES; ECHINACEA, UNSPECIFIED; ECHINOCHLOA CRUS-GALLI POLLEN; EGG; ELYMUS REPENS ROOT; ENGLISH WALNUT; EQUUS CABALLUS HAIR; EQUUS CABALLUS SKIN; EUPHRASIA STRICTA; FAGUS SYLVATICA POLLEN; FD&C BLUE NO. 2; FD&C RED NO. 3; FD&C YELLOW NO. 5; FD&C YELLOW NO. 6; FELIS CATUS HAIR; FELIS CATUS SKIN; FESTUCA PRATENSIS POLLEN; FRAXINUS EXCELSIOR POLLEN; GALLUS GALLUS FEATHER; GARLIC; GELSEMIUM SEMPERVIRENS ROOT; GINGER; GLYCYRRHIZA GLABRA; GOLDENSEAL; HADDOCK; HAZELNUT, UNSPECIFIED; HELIANTHEMUM CANADENSE; HERRING, UNSPECIFIED; HISTAMINE DIHYDROCHLORIDE; HOLCUS LANATUS POLLEN; HOUSE DUST; HUMAN DANDER; HUMAN HAIR; HUMAN SKIN; HYOSCYAMUS NIGER; JUNIPERUS VIRGINIANA TWIG; LACTOSE; LAMB; LEDUM PALUSTRE TWIG; LILIUM CANDIDUM FLOWER; LOLIUM PERENNE POLLEN; LYCOPERDON UTRIFORME FRUITING BODY; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; MATRICARIA RECUTITA; MELEAGRIS GALLOPAVO FEATHER; MELOPSITTACUS UNDULATUS FEATHER; MENTHA PIPERITA; MESOCRICETUS AURATUS HAIR; MONOSODIUM GLUTAMATE; NARCISSUS PSEUDONARCISSUS; NUTMEG; OAT; ONION; ONOSMODIUM VIRGINIANUM WHOLE; ORYCTOLAGUS CUNICULUS HAIR; ORYCTOLAGUS CUNICULUS SKIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; OYSTER, UNSPECIFIED; PEANUT; PHASIANUS COLCHICUS FEATHER; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PLATANUS ORIENTALIS POLLEN; POA PRATENSIS POLLEN; PONCEAU 4R; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; PORK; POTASSIUM BENZOATE; POTASSIUM IODIDE; PRIMULA VULGARIS; PROPYLPARABEN; PTELEA TRIFOLIATA BARK; PULSATILLA VULGARIS; QUAHOG, UNSPECIFIED; QUERCUS ALBA POLLEN; ROSA CANINA FLOWER; RYE; SACCHARIN; SACCHAROMYCES CEREVISIAE; SALIX ALBA POLLEN; SALMON, UNSPECIFIED; SAMBUCUS NIGRA FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; SCALLOP, UNSPECIFIED; SCHOENOCAULON OFFICINALE SEED; SERINUS CANARIA FEATHER; SHEEP WOOL; SHRIMP, UNSPECIFIED; SKIM MILK; SODIUM BENZOATE; SODIUM CHLORIDE; SODIUM COPPER CHLOROPHYLLIN; SODIUM DITHIONATE; SODIUM NITRITE; SODIUM TRIPOLYPHOSPHATE; SOLANUM DULCAMARA TOP; SOLANUM LYCOPERSICUM; SOLANUM NIGRUM WHOLE; SOLANUM TUBEROSUM; SULFUR; TARAXACUM OFFICINALE; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; TRILLIUM ERECTUM ROOT; TROUT, UNSPECIFIED; TUNA, UNSPECIFIED; TURKEY; ULEX EUROPAEUS FLOWER; ULMUS GLABRA POLLEN; URTICA URENS; USTILAGO MAYDIS; WHEAT; WHEAT GLUTEN; WHITE RICE; WYETHIA HELENIOIDES ROOT; XEROPHYLLUM ASPHODELOIDES; YUCCA FILAMENTOSA 60; 15; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 15; 60; 15; 15; 60; 60; 15; 3; 15; 15; 15; 60; 60; 15; 15; 15; 60; 60; 15; 15; 15; 60; 15; 15; 15; 15; 15; 15; 60; 60; 15; 60; 60; 60; 60; 60; 15; 60; 15; 15; 15; 60; 15; 60; 60; 60; 15; 15; 15; 15; 60; 15; 15; 15; 15; 3; 15; 60; 15; 15; 60; 60; 15; 15; 60; 60; 60; 60; 60; 60; 15; 15; 60; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 60; 60; 60; 15; 15; 15; 60; 15; 15; 15; 15; 15; 15; 15; 60; 60; 15; 60; 60; 15; 15; 60; 15; 15; 60; 60; 15; 60; 15; 60; 15; 15; 15; 15; 60; 15; 15; 15; 60; 60; 15; 15; 60; 15; 15; 60; 15; 15; 60; 15; 15; 15; 15; 15; 15; 60; 15; 60; 60; 60; 60; 60; 15; 60; 60; 60; 60; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 60; 15; 15; 15; 15; 60; 60; 60; 15; 30; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1708_65233e08-e8e1-fe57-9de2-902cc6efef3e 55714-1708 HUMAN OTC DRUG Tummy Upset Bismuthum metallicum, Aloe, Angelica sinensis radix, Antimon. crud., Arg. nit., Arnica, Arsenicum alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. carb., Nux vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris versicolor, Ruta, Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; ANGELICA SINENSIS ROOT; ANTIMONY TRISULFIDE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; GINGER; GOLDENSEAL; GRAPHITE; IPECAC; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; MYRRH; PHOSPHORUS; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 15; 10; 10; 3; 10; 10; 10; 10; 3; 10; 10; 3; 10; 10; 10; 3; 10; 10; 10; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1709_13ed5ab9-9b6e-2be1-1e67-09213578f9f0 55714-1709 HUMAN OTC DRUG Teething - Colic Aconitum nap., Apis mel., Baptisia, Belladonna, Borax, Bryonia, Calc. carb., Calc. phos., Chamomilla, Chelidonium majus, Coffea cruda, Collinsonia, Colocynthis, Kreosotum, Mag.phos., Nux vom., Podoph. pelt., Rheum, Scutellarialateriflora, Silicea, Terebinthina, Zingiber, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARABICA COFFEE BEAN; ATROPA BELLADONNA; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; COLLINSONIA CANADENSIS ROOT; GINGER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PODOPHYLLUM; RHEUM OFFICINALE ROOT; SCUTELLARIA LATERIFLORA; SILICON DIOXIDE; SODIUM BORATE; STRYCHNOS NUX-VOMICA SEED; TRIBASIC CALCIUM PHOSPHATE; TURPENTINE OIL; VALERIAN; WOOD CREOSOTE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1711_8215a2cb-ba70-0174-8c66-8aa5088698ee 55714-1711 HUMAN OTC DRUG Diarrhea Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Carbo veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris versicolor, Lycopodium, Mag. carb., Phosphorus, Podoph. pelt., Rheum, Sulphur, Tabacum, Vaccinium, Aesculus hipp. Juglans regia, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BILBERRY; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COLLINSONIA CANADENSIS ROOT; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; HORSE CHESTNUT; IPECAC; IRIS VERSICOLOR ROOT; JUGLANS REGIA WHOLE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; PHOSPHORUS; PODOPHYLLUM; RHEUM OFFICINALE WHOLE; SILVER NITRATE; SULFUR; TOBACCO LEAF; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1712_685ecea9-1343-6eb1-682a-740a80469f59 55714-1712 HUMAN OTC DRUG Bangs Scrapes Aconitum nap., Arnica, Bellis, Calendula, Echinacea, Gelsemium, Hamamelis, Hypericum, Ledum, Phosphorus, Rhus toxicodendron, Ruta, Staphysag., Symphytum, Hydrastis PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1713_13c1764a-6fa3-af12-79bf-96d99b1afb45 55714-1713 HUMAN OTC DRUG Bedwetting Belladonna, Cantharis, Causticum, Equisetum hyemale, Ferrum metallicum, Gelsemium, Humulus, Kali phos., Lycopodium, Nat.mur., Plantago, Pulsatilla, Rhus aromatica, Sabal, Thyroidinum, Verbascum, Echinacea, Hydrastis, Passiflora, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ATROPA BELLADONNA; CAUSTICUM; ECHINACEA, UNSPECIFIED; EQUISETUM HYEMALE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HOPS; IRON; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PASSIFLORA INCARNATA FLOWERING TOP; PLANTAGO MAJOR; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; RHUS AROMATICA ROOT BARK; SAW PALMETTO; SODIUM CHLORIDE; THYROID, UNSPECIFIED; VALERIAN; VERBASCUM THAPSUS 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1714_78ce7f38-fcf7-fa7d-a5ea-36be6a3940f5 55714-1714 HUMAN OTC DRUG Hypercalm - Mental Focus Adrenalinum, Tarentula cubensis, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Chamomilla, Coffea cruda, Cypripedium, Digitalis, Gelsemium, Humulus, Hyoscyamus, Ignatia, Impatiens glandulifera flos, Iodium, Lachesis, Lycopodium, Nat. mur., Nux vom., Scutellaria lateriflora, Staphysag., Stramonium, Theridion, Veratrum viride, Echinacea, Hypericum, Passiflora PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; CITHARACANTHUS SPINICRUS; CYPRIPEDIUM PARVIFOLUM ROOT; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; DIGITALIS; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GELSEMIUM SEMPERVIRENS ROOT; HOPS; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM; VERATRUM VIRIDE ROOT 10; 10; 10; 10; 15; 10; 10; 10; 10; 3; 15; 10; 10; 10; 3; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1715_b5ba4062-b95f-ea9c-a434-748192bb7ff3 55714-1715 HUMAN OTC DRUG Vaccination Illness Assist Influenzinum, Morbillinum, Pertussinum, Aconitum nap., Alumina, Antimon. tart., Arsenicum alb., Baptisia, Belladonna, Bryonia, Cinchona, Crotalus horridus, Gelsemium, Kali bic., Lachesis, Ledum, Merc. viv., Mezereum, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Silicea, Sulphur, Thuja occ., Vaccinium, Apis mel., Echinacea, Hypericum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALUMINUM OXIDE; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BILBERRY; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; HYPERICUM PERFORATUM; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; MEASLES VIRUS; MERCURY; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 30; 3; 30; 30; 10; 10; 30; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-1716_d920a705-8253-2ac4-f81c-33279d0bac9f 55714-1716 HUMAN OTC DRUG Bowel Digestive Care Bismuthum metallicum, Antimon.crud., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Chamomilla, Cinchona, Iris versicolor, Kali bic., Lachesis, Lycopodium, Mag. carb., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Raphanus, Rhus toxicodendron, Tabacum, Verbascum, Zingiber, Echinacea, Juglans regia PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; DAIKON; ECHINACEA, UNSPECIFIED; GINGER; IRIS VERSICOLOR ROOT; JUGLANS REGIA LEAF; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; PHOSPHORUS; PODOPHYLLUM; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 10; 10; 10; 15; 10; 10; 10; 3; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2001_9146c189-b164-3d6e-5e36-60e30677db72 55714-2001 HUMAN OTC DRUG Trauma Cream Hepar sulph. calc., Hypericum, Phosphorus, Aconitum nap., Arnica, Belladonna, Bellis, Calendula, Colchicum, Ledum, Millefolium, Rhus toxicodendron, Apis mel., Chamomilla, Echinacea, Hamamelis, Hydrastis, Ruta, Symphytum CREAM TOPICAL 20130611 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MATRICARIA RECUTITA; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 8; 8; 3; 8; 8; 8; 10; 8; 8; 3; 3; 3; 3; 10; 8; 3; 10; 3; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2002_2516f3a1-9f13-a31e-5ad0-bd5f4664a7b4 55714-2002 HUMAN OTC DRUG Hemorrhoid Cream Aloe, Arsenicum alb., Calc. fluor., Collinsonia, Crotalus horridus, Hydrofluoricum acidum, Lachesis, Lycopodium, Nux vom., Ratanhia, Vipera berus, Aesculus hipp., Calendula, Echinacea, Hamamelis, Hypericum, Solidago, Urtica ur. CREAM TOPICAL 20130801 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; ARSENIC TRIOXIDE; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; COLLINSONIA CANADENSIS ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROFLUORIC ACID; HYPERICUM PERFORATUM; KRAMERIA LAPPACEA ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; URTICA URENS; VIPERA BERUS VENOM 10; 10; 10; 3; 10; 10; 3; 3; 3; 10; 3; 10; 10; 10; 3; 10; 3; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2003_d6554828-640f-4b4e-03d1-cf7bc40b378a 55714-2003 HUMAN OTC DRUG Bee - Bug Bite Pulex irritans, Tarentula cubensis, Apis mel., Aranea diadema, Arnica, Formica, Grindelia, Hypericum, Lachesis, Latrodectus mactans, Ledum, Lycopodium, Mezereum, Rhus toxicodendron, Tarentula hispana, Theridion, Vespa crabro, Calendula, Echinacea, Hamamelis, Solidago CREAM TOPICAL 20130801 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARANEUS DIADEMATUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; CITHARACANTHUS SPINICRUS; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; FORMICA RUFA; GRINDELIA HIRSUTULA FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; PULEX IRRITANS; SOLIDAGO VIRGAUREA FLOWERING TOP; THERIDION CURASSAVICUM; TOXICODENDRON PUBESCENS LEAF; VESPA CRABRO 10; 10; 10; 3; 15; 10; 3; 10; 10; 3; 10; 10; 10; 10; 10; 10; 15; 3; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2005_8beb84de-4842-4cac-9118-6d33fa64b1d9 55714-2005 HUMAN OTC DRUG Arnica Cream Arnica montana CREAM TOPICAL 20130801 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARNICA MONTANA 60 [hp_X]/g 55714-2200_f47838bd-542f-8185-add9-c0c4d8060efc 55714-2200 HUMAN OTC DRUG Detoxifier Uricum acidum, Benzoicum acidum, Berber. vulg., Bryonia, Cantharis, Carduus benedictus, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Dioscorea, Dolichos, Iris versicolor, Juniperus com., Nux vom.,Ptelea,Taraxacum, Carduus mar., Cynara scolymus, Solidago,Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CNICUS BENEDICTUS; CYNARA SCOLYMUS LEAF; DIOSCOREA VILLOSA TUBER; IRIS VERSICOLOR ROOT; JUNIPER; LYTTA VESICATORIA; MUCUNA PRURIENS FRUIT TRICHOME; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TARAXACUM OFFICINALE; URIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 3; 3; 10; 10; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2201_4d2352c7-8ba2-3d1c-a2dd-aac7156057ac 55714-2201 HUMAN OTC DRUG Detoxifier Uricum acidum, Benzoicum acidum, Berber. vulg., Bryonia, Cantharis, Carduus benedictus, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Dioscorea, Dolichos, Iris versicolor, Juniperus com., Nux vom.,Ptelea,Taraxacum, Carduus mar., Cynara scolymus, Solidago PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; DIOSCOREA VILLOSA TUBER; IRIS VERSICOLOR ROOT; JUNIPER BERRY; LYTTA VESICATORIA; MUCUNA PRURIENS FRUIT TRICHOME; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; URIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 3; 3; 10; 10; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2202_212741e9-c321-967c-3e13-379b9880d497 55714-2202 HUMAN OTC DRUG Cough - Asthma Influenza A Virus, Influenza B Virus, Antimon. tart., Arsenicum alb., Bryonia, Chelidonium majus, Cinchona, Drosera, Eucalyptus, Histaminum hydrochloricum, Hydrastis, Kali bic., Kali carb.,Kali iod., Myrrha, Nat. sulphuricum, Nux vom., Phosphorus, Pulsatilla, Rumex crisp., Sambucus nig., Spongia, Tussilago farfara, Verbascum, Echinacea, Lappa LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY POTASSIUM TARTRATE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA FLOWERING TOP; ECHINACEA, UNSPECIFIED; EUCALYPTUS GLOBULUS LEAF; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; MYRRH; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS NUX-VOMICA SEED; TUSSILAGO FARFARA; VERBASCUM THAPSUS 15; 3; 15; 15; 15; 15; 15; 3; 15; 15; 15; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2203_904de3bf-b0e8-9558-b4d9-96da25e2b223 55714-2203 HUMAN OTC DRUG Cough - Asthma Influenza A Virus, Influenza B Virus, Antimon. tart., Arsenicum alb., Bryonia, Chelidonium majus, Cinchona, Drosera, Eucalyptus, Histaminum hydrochloricum, Hydrastis, Kali bic., Kali carb.,Kali iod., Myrrha, Nat. sulphuricum, Nux vom., Phosphorus, Pulsatilla, Rumex crisp., Sambucus nig., Spongia, Tussilago farfara, Verbascum, Echinacea, Lappa PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY POTASSIUM TARTRATE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA FLOWERING TOP; ECHINACEA, UNSPECIFIED; EUCALYPTUS GLOBULUS LEAF; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; MYRRH; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS NUX-VOMICA SEED; TUSSILAGO FARFARA; VERBASCUM THAPSUS 15; 3; 15; 15; 15; 15; 15; 3; 15; 15; 15; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2204_54ad4ff3-4971-9a2d-f8b9-bc33bb268758 55714-2204 HUMAN OTC DRUG Cold - Sinus Influenza A Virus, Influenza B Virus, Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procubens, Gelsemium, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Kali bic., Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabadilla, Salvia, Sticta, Verbascum, Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LOBARIA PULMONARIA; MERCURY; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SAGE; SCHOENOCAULON OFFICINALE SEED; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2205_b2cbd0bb-ebab-ae20-ab3f-a612c0cc81bd 55714-2205 HUMAN OTC DRUG Cold - Sinus Influenza A Virus, Influenza B Virus, Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procubens, Gelsemium, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Kali bic., Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabadilla, Salvia, Sticta, Verbascum, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LOBARIA PULMONARIA; MERCURY; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SAGE; SCHOENOCAULON OFFICINALE SEED; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2206_145b2b8f-93c5-a368-58f7-813af13f5fd0 55714-2206 HUMAN OTC DRUG Fever - Infection Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Aconitum nap., Antimon. tart., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Cinchona, Eupatorium perf., Ferrum metallicum, Gelsemium, Hepar sulph.calc., Iodium, Lachesis, Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Salix nigra, Verbascum, Apis mel., Echinacea, Hydrastis LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IODINE; IRON; LACHESIS MUTA VENOM; LYTTA VESICATORIA; MATRICARIA RECUTITA; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; RANCID BEEF; SALIX NIGRA BARK; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 15; 15; 3; 15; 15; 15; 30; 15; 15; 15; 15; 3; 15; 15; 3; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2207_d6d0089c-c96d-9853-a529-ae94e76db4f5 55714-2207 HUMAN OTC DRUG Fever - Infection Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Aconitum nap., Antimon. tart., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Cinchona, Eupatorium perf., Ferrum metallicum, Gelsemium, Hepar sulph.calc., Iodium, Lachesis, Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Salix nigra, Verbascum, Apis mel., Echinacea, Hydrastis PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IODINE; IRON; LACHESIS MUTA VENOM; LYTTA VESICATORIA; MATRICARIA RECUTITA; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; RANCID BEEF; SALIX NIGRA BARK; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 15; 15; 3; 15; 15; 15; 30; 15; 15; 15; 15; 3; 15; 15; 3; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2208_d9a9c624-f191-4003-76e4-a0fbb1ab7c0a 55714-2208 HUMAN OTC DRUG Flu Care Influenza A Virus, Influenza B Virus, Histaminum hydrochloricum, Aconitum nap., Aralia quinquefolia, Arsenicum alb., Baptisia, Bryonia, Cinchona, Eupatorium perf., Gelsemium, Ipecac., Kali carb., Nux vom., Phosphorus, Rhus toxicodendron, Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IPECAC; PHOSPHORUS; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 3; 10; 10; 15; 30; 30; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2209_d0f6f2f6-08c2-7858-3390-7bac99a3ee25 55714-2209 HUMAN OTC DRUG Flu Care Influenza A Virus, Influenza B Virus, Histaminum hydrochloricum, Aconitum nap., Aralia quinquefolia, Arsenicum alb., Baptisia, Bryonia, Cinchona, Eupatorium perf., Gelsemium, Ipecac., Kali carb., Nux vom., Phosphorus, Rhus toxicodendron, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IPECAC; PHOSPHORUS; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 3; 10; 10; 15; 30; 30; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2210_f7907f9b-497a-eeb7-c00e-18df28640c7e 55714-2210 HUMAN OTC DRUG Ear Care Influenzinum, Tellurium metallicum, Apis mel., Arsenicum alb., Belladonna, Bryonia, Capsicum, Causticum, Cinchona, Conium, Dulcamara, Ferrum phosphoricum, Hepar sulph. calc.,Kali sulph., Lycopodium, Merc. viv., Mezereum, Phosphorus, Plantago, Pulsatilla, Silicea, Verbascum, Echinacea, Hydrastis LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORUS; PLANTAGO MAJOR; POTASSIUM SULFATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; TELLURIUM; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 3; 30; 30; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2211_85195ea2-4a34-d6e5-ea1c-c3517b09f4aa 55714-2211 HUMAN OTC DRUG Ear Care Influenzinum, Tellurium metallicum, Apis mel., Arsenicum alb., Belladonna, Bryonia, Capsicum, Causticum, Cinchona, Conium, Dulcamara, Ferrum phosphoricum, Hepar sulph. calc.,Kali sulph., Lycopodium, Merc. viv., Mezereum, Phosphorus, Plantago, Pulsatilla, Silicea, Verbascum, Echinacea, Hydrastis PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORUS; PLANTAGO MAJOR; POTASSIUM SULFATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; TELLURIUM; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 3; 30; 30; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2212_84667426-1e7c-94f3-ed14-808c1ec2877e 55714-2212 HUMAN OTC DRUG Hay Fever Zerophyllum asphodeloides, Alfalfa, Avena sativa pollen, Cynosurus cristatus pollen, Echinochloa crus-galli pollen, Poa pratensis pollen, Anthoxanthum odoratum pollen, Agrostis gigantea pollen, Bromus secalinus pollen, Alopecurus pratensis pollen, Phleum pratense pollen, Festuca pratensis pollen, Holcus lanatus pollen, Lolium perenne pollen, Fagus sylvatica pollen, Betula pendula pollen, Quercus alba pollen, Fraxinus excelsior pollen, Corylus americana pollen, Populus nigra pollen LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AGROSTIS GIGANTEA POLLEN; ALFALFA; ALOPECURUS PRATENSIS POLLEN; AMBROSIA ARTEMISIIFOLIA; AMMONIUM CARBONATE; ANTHOXANTHUM ODORATUM POLLEN; APIS MELLIFERA; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; ARUNDO PLINIANA ROOT; AVENA SATIVA POLLEN; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; BETULA PENDULA POLLEN; BROMUS SECALINUS POLLEN; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALLUNA VULGARIS POLLEN; CHELIDONIUM MAJUS; CORYLUS AMERICANA POLLEN; CRATAEGUS MONOGYNA POLLEN; CYNOSURUS CRISTATUS POLLEN; CYTISUS SCOPARIUS POLLEN; DATURA STRAMONIUM; DIANTHUS CARYOPHYLLUS FLOWER; DROSERA ROTUNDIFOLIA; DYSPHANIA AMBROSIOIDES; ECHINACEA, UNSPECIFIED; ECHINOCHLOA CRUS-GALLI POLLEN; ELYMUS REPENS ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; FAGUS SYLVATICA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS EXCELSIOR POLLEN; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; HOLCUS LANATUS POLLEN; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LILIUM CANDIDUM FLOWER; LOLIUM PERENNE POLLEN; LYCOPODIUM CLAVATUM SPORE; NARCISSUS PSEUDONARCISSUS; ONION; ONOSMODIUM VIRGINIANUM WHOLE; PHLEUM PRATENSE POLLEN; PLATANUS ORIENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PRIMULA VULGARIS; PULSATILLA VULGARIS; QUERCUS ALBA POLLEN; ROSA CANINA FLOWER; SALIX ALBA POLLEN; SANGUINARIA CANADENSIS ROOT; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; TRILLIUM ERECTUM ROOT; ULEX EUROPAEUS FLOWER; ULMUS GLABRA POLLEN; URTICA URENS; USTILAGO MAYDIS; WYETHIA HELENIOIDES ROOT; XEROPHYLLUM ASPHODELOIDES 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2213_f9159ed6-233e-a6bd-3c68-4e498ef8d56b 55714-2213 HUMAN OTC DRUG Hay Fever Zerophyllum asphodeloides, Alfalfa, Avena sativa pollen, Cynosurus cristatus pollen, Echinochloa crus-galli pollen, Poa pratensis pollen, Anthoxanthum odoratum pollen, Agrostis gigantea pollen, Bromus secalinus pollen, Alopecurus pratensis pollen, Phleum pratense pollen, Festuca pratensis pollen, Holcus lanatus pollen, Lolium perenne pollen, Fagus sylvatica pollen, Betula pendula pollen, Quercus alba pollen, Fraxinus excelsior pollen, Corylus americana pollen, Populus nigra pollen PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AGROSTIS GIGANTEA POLLEN; ALFALFA; ALOPECURUS PRATENSIS POLLEN; AMBROSIA ARTEMISIIFOLIA; AMMONIUM CARBONATE; ANTHOXANTHUM ODORATUM POLLEN; APIS MELLIFERA; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; ARUNDO PLINIANA ROOT; AVENA SATIVA POLLEN; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; BETULA PENDULA POLLEN; BROMUS SECALINUS POLLEN; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALLUNA VULGARIS POLLEN; CHELIDONIUM MAJUS; CORYLUS AMERICANA POLLEN; CRATAEGUS MONOGYNA POLLEN; CYNOSURUS CRISTATUS POLLEN; CYTISUS SCOPARIUS POLLEN; DATURA STRAMONIUM; DIANTHUS CARYOPHYLLUS FLOWER; DROSERA ROTUNDIFOLIA; DYSPHANIA AMBROSIOIDES; ECHINACEA, UNSPECIFIED; ECHINOCHLOA CRUS-GALLI POLLEN; ELYMUS REPENS ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; FAGUS SYLVATICA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS EXCELSIOR POLLEN; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; HOLCUS LANATUS POLLEN; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LILIUM CANDIDUM FLOWER; LOLIUM PERENNE POLLEN; LYCOPODIUM CLAVATUM SPORE; NARCISSUS PSEUDONARCISSUS; ONION; ONOSMODIUM VIRGINIANUM WHOLE; PHLEUM PRATENSE POLLEN; PLATANUS ORIENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PRIMULA VULGARIS; PULSATILLA VULGARIS; QUERCUS ALBA POLLEN; ROSA CANINA FLOWER; SALIX ALBA POLLEN; SANGUINARIA CANADENSIS ROOT; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; TRILLIUM ERECTUM ROOT; ULEX EUROPAEUS FLOWER; ULMUS GLABRA POLLEN; URTICA URENS; USTILAGO MAYDIS; WYETHIA HELENIOIDES ROOT; XEROPHYLLUM ASPHODELOIDES 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2214_8000590d-d626-8597-97c5-945c44c38228 55714-2214 HUMAN OTC DRUG Constipation Abies nig., Aesculus hipp., Aloe, Alumina, Bryonia, Carbo veg., Chelidonium majus, Collinsonia , Graphites, Hydrastis, Kali carb., Lycopodium, Mag. mur., Mezereum, Nux vom., Podoph. pelt., Rhamnus purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum alb., Zinc.met., Echinacea, Iris versicolor, Phytolacca, Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; FRANGULA PURSHIANA BARK; GOLDENSEAL; GRAPHITE; HORSE CHESTNUT; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; PHYTOLACCA AMERICANA ROOT; PICEA MARIANA RESIN; PODOPHYLLUM; POTASSIUM CARBONATE; SANICULA EUROPAEA LEAF; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TOBACCO LEAF; VERATRUM ALBUM ROOT; ZINC 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2215_1ee631ce-1ae4-030a-8ddf-e911d0eb097d 55714-2215 HUMAN OTC DRUG Constipation Abies nig., Aesculus hipp., Aloe, Alumina, Bryonia, Carbo veg., Chelidonium majus, Collinsonia , Graphites, Hydrastis, Kali carb., Lycopodium, Mag. mur., Mezereum, Nux vom., Podoph. pelt., Rhamnus purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum alb., Zinc.met., Echinacea, Iris versicolor, Phytolacca, Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; FRANGULA PURSHIANA BARK; GOLDENSEAL; GRAPHITE; HORSE CHESTNUT; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; PHYTOLACCA AMERICANA ROOT; PICEA MARIANA RESIN; PODOPHYLLUM; POTASSIUM CARBONATE; SANICULA EUROPAEA LEAF; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TOBACCO LEAF; VERATRUM ALBUM ROOT; ZINC 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2216_4d6fdfdb-fe73-450a-cfe8-cec6fc35ec5a 55714-2216 HUMAN OTC DRUG Rheumatic Joint Care Uricum acidum, Aconitum nap.,Apis mel., Arnica, Arsenicum alb, Belladonna,Benzoicum acidum, Bryonia, Calc. carb., Chamomilla, Cinchona, Colchicum, Eupatorium perf., Gaultheriaprocumbens, Guaiacum, Iodium, Kali bic, Kalmia,Ledum, Pulsatilla, Rhus toxicodendron, Ruta,Sabina, Strychninum, Lappa, Phytolacca, Symphytum, LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARCTIUM LAPPA ROOT; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GAULTHERIA PROCUMBENS TOP; GUAIACUM OFFICINALE RESIN; IODINE; JUNIPERUS SABINA LEAFY TWIG; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; STRYCHNINE; TOXICODENDRON PUBESCENS LEAF; URIC ACID 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2217_e3670da3-03f6-4bed-4561-f244b9fa1df9 55714-2217 HUMAN OTC DRUG Rheumatic - Joint Care Uricum acidum, Aconitum nap.,Apis mel., Arnica, Arsenicum alb, Belladonna,Benzoicum acidum, Bryonia, Calc. carb., Chamomilla, Cinchona, Colchicum, Eupatorium perf., Gaultheriaprocumbens, Guaiacum, Iodium, Kali bic, Kalmia,Ledum, Pulsatilla, Rhus toxicodendron, Ruta,Sabina, Strychninum, Lappa, Phytolacca, Symphytum, PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARCTIUM LAPPA ROOT; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GAULTHERIA PROCUMBENS TOP; GUAIACUM OFFICINALE RESIN; IODINE; JUNIPERUS SABINA LEAFY TWIG; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; STRYCHNINE; TOXICODENDRON PUBESCENS LEAF; URIC ACID 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2218_2482a5ff-c152-dc04-40f7-40b3a14821ee 55714-2218 HUMAN OTC DRUG Bladder - Kidney Apis mel., Berber. vulg., Bryonia, Cantharis, Cinchona, Equisetum hyemale, Ferrum phosphoricum, Gelsemium, Juniperus com., Pareira, Phosphorus, Plantago, Pulsatilla, Sabal, Terebinthina, Uva-ursi, Echinacea, Hydrastis, Lappa, Solidago LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARCTIUM LAPPA ROOT; ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHONDRODENDRON TOMENTOSUM ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EQUISETUM HYEMALE; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; JUNIPER BERRY; LYTTA VESICATORIA; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; TURPENTINE 15; 3; 15; 15; 15; 15; 15; 3; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2219_372b7f45-a22b-73a6-d32e-3ec0a96bcdc2 55714-2219 HUMAN OTC DRUG Bladder - Kidney Apis mel., Berber. vulg., Bryonia, Cantharis, Cinchona, Equisetum hyemale, Ferrum phosphoricum, Gelsemium, Juniperus com., Pareira, Phosphorus, Plantago, Pulsatilla, Sabal, Terebinthina, Uva-ursi, Echinacea, Hydrastis, Lappa, Solidago PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARCTIUM LAPPA ROOT; ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHONDRODENDRON TOMENTOSUM ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EQUISETUM HYEMALE; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; JUNIPER BERRY; LYTTA VESICATORIA; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; TURPENTINE 15; 3; 15; 15; 15; 15; 15; 3; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2220_ddd495f4-3e48-5b11-5a23-17f6c1d070d8 55714-2220 HUMAN OTC DRUG Hemorrhoids Elaps corallinus, Aesculus hipp., Aloe, Arsenicum alb., Bryonia, Calc. fluor., Capsicum, Collinsonia, Crotalus horridus, Hamamelis, Hydrofluoricum acidum, Hypericum, Lachesis, Lycopodium, Millefolium, Naja, Nux vom., Paeonia, Plantago, Quercus glandium spiritus, Ratanhia, Vipera berus, Echinacea, Solidago, Urtica ur. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACHILLEA MILLEFOLIUM; ALOE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAPSICUM; COLLINSONIA CANADENSIS ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROFLUORIC ACID; HYPERICUM PERFORATUM; KRAMERIA LAPPACEA ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; PAEONIA OFFICINALIS ROOT; PLANTAGO MAJOR; QUERCUS ROBUR NUT; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; URTICA URENS; VIPERA BERUS VENOM 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 3; 15; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2221_84365aa1-1068-c019-b6cb-e2688e8b2594 55714-2221 HUMAN OTC DRUG Hemorrhoids Elaps corallinus, Aesculus hipp., Aloe, Arsenicum alb., Bryonia, Calc. fluor., Capsicum, Collinsonia, Crotalus horridus, Hamamelis, Hydrofluoricum acidum, Hypericum, Lachesis, Lycopodium, Millefolium, Naja, Nux vom., Paeonia, Plantago, Quercus glandium spiritus, Ratanhia, Vipera berus, Echinacea, Solidago, Urtica ur. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACHILLEA MILLEFOLIUM; ALOE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAPSICUM; COLLINSONIA CANADENSIS ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROFLUORIC ACID; HYPERICUM PERFORATUM; KRAMERIA LAPPACEA ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; PAEONIA OFFICINALIS ROOT; PLANTAGO MAJOR; QUERCUS ROBUR NUT; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; URTICA URENS; VIPERA BERUS VENOM 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 3; 15; 3; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2222_6b236223-d5f5-813b-5de9-2f3e11c9f49b 55714-2222 HUMAN OTC DRUG Menstrual - PMS Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga, Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia,Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACHILLEA MILLEFOLIUM; ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BLACK COHOSH; BRYONIA ALBA ROOT; CAPSELLA BURSA-PASTORIS; CAULOPHYLLUM THALICTROIDES ROOT; CINCHONA OFFICINALIS BARK; CLAVICEPS PURPUREA SCLEROTIUM; DIOSCOREA VILLOSA TUBER; ECHINACEA, UNSPECIFIED; ESTRONE; GELSEMIUM SEMPERVIRENS ROOT; GINGER; JUNIPERUS SABINA LEAFY TWIG; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; VALERIAN; VIBURNUM OPULUS BARK 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2223_2c0a0a6b-fb4a-86b4-0da2-dc7de9a191c2 55714-2223 HUMAN OTC DRUG Menstrual - PMS Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga, Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia,Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACHILLEA MILLEFOLIUM; ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BLACK COHOSH; BRYONIA ALBA ROOT; CAPSELLA BURSA-PASTORIS; CAULOPHYLLUM THALICTROIDES ROOT; CINCHONA OFFICINALIS BARK; CLAVICEPS PURPUREA SCLEROTIUM; DIOSCOREA VILLOSA TUBER; ECHINACEA, UNSPECIFIED; ESTRONE; GELSEMIUM SEMPERVIRENS ROOT; GINGER; JUNIPERUS SABINA LEAFY TWIG; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; VALERIAN; VIBURNUM OPULUS BARK 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2224_7bf153b1-81d7-9102-9fc7-2165fa2b12a5 55714-2224 HUMAN OTC DRUG Headache Elaps corallinus, Arsenicum alb., Belladonna, Bryonia, Carduus benedictus, Cimicifuga, Coffea cruda, Convallaria, Crotalus horridus, Digitalis, Gelsemium, Glonoinum, Ignatia, Lachesis, Merc. viv., Naja, Nux vom., Phosphorus, Rhus toxicodendron, Sanguinaria, Secale, Vipera berus, Apis mel., Hypericum, Thuja occ.. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CLAVICEPS PURPUREA SCLEROTIUM; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; MERCURY; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; SANGUINARIA CANADENSIS ROOT; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; VIPERA BERUS VENOM 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 30; 15; 15; 15; 15; 15; 15; 3; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2225_222d9bf1-0d40-7e02-8a94-d31d54a7690c 55714-2225 HUMAN OTC DRUG Headache Elaps corallinus, Arsenicum alb., Belladonna, Bryonia, Carduus benedictus, Cimicifuga, Coffea cruda, Convallaria, Crotalus horridus, Digitalis, Gelsemium, Glonoinum, Ignatia, Lachesis, Merc. viv., Naja, Nux vom., Phosphorus, Rhus toxicodendron, Sanguinaria, Secale, Vipera berus, Apis mel., Hypericum, Thuja occ.. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CLAVICEPS PURPUREA SCLEROTIUM; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; MERCURY; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; SANGUINARIA CANADENSIS ROOT; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; VIPERA BERUS VENOM 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 30; 15; 15; 15; 15; 15; 15; 3; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2226_0ba48a10-49f5-bf35-ccca-335bf1b5c4eb 55714-2226 HUMAN OTC DRUG Fungus Fighter Candida albicans, Sanicula, Tellurium metallicum, Torula cerevisiae, Antimon. crud., Arsenicum alb., Baryta carb., Bryonia, Calc. carb., Carbo veg., Cuprum met., Dulcamara, Graphites, Kali carb., Lachesis, Lycopodium, Mezereum, Nitricum ac., Phosphorus, Phytolacca, Sepia, Silicea, Sulphur, Sulphuricum ac., Zinc. met., Apis mel., Thuja occ. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; CANDIDA ALBICANS; COPPER; DAPHNE MEZEREUM BARK; GRAPHITE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; SACCHAROMYCES CEREVISIAE; SANICULA EUROPAEA LEAF; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; SULFUR; SULFURIC ACID; TELLURIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 10; 10; 3; 10; 10; 10; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 15; 10; 10; 10; 10; 10; 15; 3; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2227_2a3164af-a062-0d52-437a-0132cd16ad1f 55714-2227 HUMAN OTC DRUG Fungus Fighter Candida albicans, Sanicula, Tellurium metallicum, Torula cerevisiae, Antimon. crud., Arsenicum alb., Baryta carb., Bryonia, Calc. carb., Carbo veg., Cuprum met., Dulcamara, Graphites, Kali carb., Lachesis, Lycopodium, Mezereum, Nitricum ac., Phosphorus, Phytolacca, Sepia, Silicea, Sulphur, Sulphuricum ac., Zinc. met., Apis mel., Thuja occ. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; CANDIDA ALBICANS; COPPER; DAPHNE MEZEREUM BARK; GRAPHITE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; SACCHAROMYCES CEREVISIAE; SANICULA EUROPAEA LEAF; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; SULFUR; SULFURIC ACID; TELLURIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 10; 10; 3; 10; 10; 10; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 15; 10; 10; 10; 10; 10; 15; 3; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2228_ea7493a8-7cb8-4fa3-7ece-6020e794adbf 55714-2228 HUMAN OTC DRUG Acne Antimon. crud., Arsenicum alb., Aur. met., Berber. aqui., Bovista, Carbo veg., Causticum, Chelidonium majus, Dulcamara, Graphites, Hepar sulph. calc., Hydrocotyle, Kali brom., Kali iod., Ledum, Lycopodium, Nux vom., Silicea, Sulphur iod., Zinc. met., Echinacea, Juglans regia, Lappa, Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; CALCIUM SULFIDE; CAUSTICUM; CENTELLA ASIATICA; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT; GIANT PUFFBALL; GOLD; GRAPHITE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; MAHONIA AQUIFOLIUM ROOT BARK; POTASSIUM BROMIDE; POTASSIUM IODIDE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR IODIDE; TARAXACUM OFFICINALE; ZINC 15; 15; 3; 15; 15; 15; 15; 15; 3; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2229_b0d315f3-f02b-d0d5-ea42-8feb0c51a836 55714-2229 HUMAN OTC DRUG Acne Antimon. crud., Arsenicum alb., Aur. met., Berber. aqui., Bovista, Carbo veg., Causticum, Chelidonium majus, Dulcamara, Graphites, Hepar sulph. calc., Hydrocotyle, Kali brom., Kali iod., Ledum, Lycopodium, Nux vom., Silicea, Sulphur iod., Zinc. met., Echinacea, Juglans regia, Lappa, Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARSENIC CATION (3+); CALCIUM SULFIDE; CAUSTICUM; CENTELLA ASIATICA; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT; GIANT PUFFBALL; GOLD; GRAPHITE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; MAHONIA AQUIFOLIUM ROOT BARK; POTASSIUM BROMIDE; POTASSIUM IODIDE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR IODIDE; TARAXACUM OFFICINALE; ZINC 15; 15; 3; 15; 15; 15; 15; 15; 3; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2230_38a82782-b42f-262a-cef9-2af58f786898 55714-2230 HUMAN OTC DRUG Candida - Yeast Adrenalinum, Candida albicans, Thyroidinum, Torula cerevisiae, Triticum, Ustilago maidis, Antimon. crud, Arsenicum alb., Baptisia, Berber. aqui., Bryonia, Calc. phos., Cinchona, Helonias dioica, Hydrastis, Iodium, Iris versicolor, Kali carb., Lachesis, Lycopodium, Merc. viv., Nat.carb., Nat. phos, Nitricum ac., Phosphorus, Podoph. pelt, Pulsatilla, Sepia, Echinacea, Ginkgo, Juglans regia, Lappa, Thuja occ. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CANDIDA ALBICANS; CHAMAELIRIUM LUTEUM ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; ELYMUS REPENS ROOT; ENGLISH WALNUT; EPINEPHRINE; GINKGO; GOLDENSEAL; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAHONIA AQUIFOLIUM ROOT BARK; MERCURY; NITRIC ACID; PHOSPHORUS; PODOPHYLLUM; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE; SODIUM CARBONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRIBASIC CALCIUM PHOSPHATE; USTILAGO MAYDIS 10; 3; 10; 10; 10; 15; 10; 10; 3; 15; 3; 15; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10; 10; 10; 3; 15; 10; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2231_ef1d8aed-0868-02a5-3d69-708674db6acc 55714-2231 HUMAN OTC DRUG Candida - Yeast Adrenalinum, Candida albicans, Thyroidinum, Torula cerevisiae, Triticum, Ustilago maidis, Antimon. crud, Arsenicum alb., Baptisia, Berber. aqui., Bryonia, Calc. phos., Cinchona, Helonias dioica, Hydrastis, Iodium, Iris versicolor, Kali carb., Lachesis, Lycopodium, Merc. viv., Nat.carb., Nat. phos, Nitricum ac., Phosphorus, Podoph. pelt, Pulsatilla, Sepia, Echinacea, Ginkgo, Juglans regia, Lappa, Thuja occ. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CANDIDA ALBICANS; CHAMAELIRIUM LUTEUM ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; ELYMUS REPENS ROOT; ENGLISH WALNUT; EPINEPHRINE; GINKGO; GOLDENSEAL; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAHONIA AQUIFOLIUM ROOT BARK; MERCURY; NITRIC ACID; PHOSPHORUS; PODOPHYLLUM; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE; SODIUM CARBONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRIBASIC CALCIUM PHOSPHATE; USTILAGO MAYDIS 10; 3; 10; 10; 10; 15; 10; 10; 3; 15; 3; 15; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10; 10; 10; 3; 15; 10; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2232_494c0f5a-9b21-8cff-5dbf-3a70bc869a8a 55714-2232 HUMAN OTC DRUG Eczema - Skin Care Antimon. crud., Arsenicum alb., Berber. vulg., Bovista, Bryonia, Cantharis, Chelidonium majus, Croton, Dulcamara, Graphites, Hepar sulph. calc., Lycopodium, Mezereum, Nux vom., Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sepia, Sulphur iod., Echinacea, Rumex crisp., Taraxacum, Urtica ur. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GIANT PUFFBALL; GRAPHITE; KEROSENE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PULEX IRRITANS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SEPIA OFFICINALIS JUICE; SMILAX REGELII ROOT; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR IODIDE; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 3; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2233_cb6362d0-cacc-9436-ac90-a2a982e15145 55714-2233 HUMAN OTC DRUG Eczema - Skin Care Antimon. crud., Arsenicum alb., Berber. vulg., Bovista, Bryonia, Cantharis, Chelidonium majus, Croton, Dulcamara, Graphites, Hepar sulph. calc., Lycopodium, Mezereum, Nux vom., Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sepia, Sulphur iod., Echinacea, Rumex crisp., Taraxacum, Urtica ur. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GIANT PUFFBALL; GRAPHITE; KEROSENE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PULEX IRRITANS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SEPIA OFFICINALIS JUICE; SMILAX REGELII ROOT; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR IODIDE; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 3; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2234_e61c2a0b-f1ff-3747-81a2-21bb534af2a0 55714-2234 HUMAN OTC DRUG Menopause Elaps corallinus, Agnus, Angelica sinensis radix, Arsenicum alb., Bryonia, Cantharis, Caulophyllum, Cimicifuga, Cinchona, Crotalus horridus, Damiana, Glonoinum, Helonias dioica, Ignatia, Kali carb., Lachesis, Naja, Nux vom., Phosphorus, Pulsatilla, Salix nigra, Sanguinaria, Sepia, Echinacea, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BLACK COHOSH; BRYONIA ALBA ROOT; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; LYTTA VESICATORIA; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TURNERA DIFFUSA LEAFY TWIG; VALERIAN 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2235_f26cd39b-1c0a-f6cd-1250-169ab3e7654f 55714-2235 HUMAN OTC DRUG Menopause Elaps corallinus, Agnus, Angelica sinensis radix, Arsenicum alb., Bryonia, Cantharis, Caulophyllum, Cimicifuga, Cinchona, Crotalus horridus, Damiana, Glonoinum, Helonias dioica, Ignatia, Kali carb., Lachesis, Naja, Nux vom., Phosphorus, Pulsatilla, Salix nigra, Sanguinaria, Sepia, Echinacea, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BLACK COHOSH; BRYONIA ALBA ROOT; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; LYTTA VESICATORIA; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TURNERA DIFFUSA LEAFY TWIG; VALERIAN 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2236_2a43b9d4-f70d-40ad-1719-06e7e8103b7a 55714-2236 HUMAN OTC DRUG Aches - Pains Aconitum nap., Arg. nit., Arnica, Bryonia, Colchicum, Guaiacum, Hypericum, Kalmia, Phosphorus, Phytolacca, Pulsatilla, Rhus toxicodendron, Ruta, Sarcolacticum ac., Sticta, Stramonium, Hamamelis, Taraxacum, LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; DATURA STRAMONIUM; GUAIAC; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; LACTIC ACID, L-; LOBARIA PULMONARIA; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2237_9a8589d3-48b0-0b1a-f3c0-255cd9e7afa9 55714-2237 HUMAN OTC DRUG Aches - Pains Aconitum nap., Arg. nit., Arnica, Bryonia, Colchicum, Guaiacum, Hypericum, Kalmia, Phosphorus, Phytolacca, Pulsatilla, Rhus toxicodendron, Ruta, Sarcolacticum ac., Sticta, Stramonium, Hamamelis, Taraxacum, PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; DATURA STRAMONIUM; GUAIAC; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; LACTIC ACID, L-; LOBARIA PULMONARIA; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2238_affa5226-f83d-dfe2-2376-3c87e69267d7 55714-2238 HUMAN OTC DRUG Indigestion - Gas Bismuthum metallicum, Aloe, Angelica sinensis radix, Antimon. crud., Arg. nit., Arnica, Arsenicum alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. carb., Nux vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris versicolor, Ruta, Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; ANGELICA SINENSIS ROOT; ANTIMONY TRISULFIDE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; GINGER; GOLDENSEAL; GRAPHITE; IPECAC; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; MYRRH; PHOSPHORUS; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 15; 10; 10; 3; 10; 10; 10; 10; 3; 10; 10; 3; 10; 10; 10; 3; 10; 10; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2239_c97b712e-1ed9-761c-9ce7-73186d4d2f6b 55714-2239 HUMAN OTC DRUG Indigestion - Gas Bismuthum metallicum, Aloe, Angelica sinensis radix, Antimon. crud., Arg. nit., Arnica, Arsenicum alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. carb., Nux vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris versicolor, Ruta, Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; ANGELICA SINENSIS ROOT; ANTIMONY TRISULFIDE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; GINGER; GOLDENSEAL; GRAPHITE; IPECAC; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; MYRRH; PHOSPHORUS; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 15; 10; 10; 3; 10; 10; 10; 10; 3; 10; 10; 3; 10; 10; 10; 3; 10; 10; 10; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2240_367ae7d0-ec2d-4930-bd02-ddd65c299529 55714-2240 HUMAN OTC DRUG Varicose Veins Elaps corallinus, Crotalus horridus, Bryonia, Calc. fluor., Carduus mar., Cholesterinum, Cinchona, Digitalis, Hamamelis, Hydrofluoricum acidum, Lachesis, Lycopodium, Naja, Pulsatilla, Vipera berus, Zinc. met., Aesculus hipp., Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROFLUORIC ACID; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; PULSATILLA VULGARIS; SILYBUM MARIANUM SEED; VIPERA BERUS VENOM; ZINC 10; 10; 10; 10; 15; 10; 3; 10; 3; 10; 10; 10; 30; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2241_5d8d0852-0527-53cd-a011-2a2de9f76b49 55714-2241 HUMAN OTC DRUG Varicose Veins Elaps corallinus, Crotalus horridus, Bryonia, Calc. fluor., Carduus mar., Cholesterinum, Cinchona, Digitalis, Hamamelis, Hydrofluoricum acidum, Lachesis, Lycopodium, Naja, Pulsatilla, Vipera berus, Zinc. met., Aesculus hipp., Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROFLUORIC ACID; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; PULSATILLA VULGARIS; SILYBUM MARIANUM SEED; VIPERA BERUS VENOM; ZINC 10; 10; 10; 10; 15; 10; 3; 10; 3; 10; 10; 10; 30; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2242_00403596-96f3-6bfc-bd1c-f2b602baea49 55714-2242 HUMAN OTC DRUG Prostate Thyroidinum, Baryta carb., Berber. vulg., Bryonia, Calc. carb., Cinchona, Conium, Digitalis, Ferrum picricum, Hydrastis, Iodium, Lycopodium, Nux vom., Pareira, Pulsatilla, Sabal, Selenium, Staphysag., Thuja occ.,Trifolium pratense, Echinacea, Lappa, Solidago. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARCTIUM LAPPA ROOT; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHONDRODENDRON TOMENTOSUM ROOT; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; DIGITALIS; ECHINACEA, UNSPECIFIED; FERRIC PICRATE; GOLDENSEAL; IODINE; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SAW PALMETTO; SELENIUM; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER 3; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 15; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2243_56b5b5ba-f96a-f40a-5e69-c59d9649b8ec 55714-2243 HUMAN OTC DRUG Prostate Thyroidinum, Baryta carb., Berber. vulg., Bryonia, Calc. carb., Cinchona, Conium, Digitalis, Ferrum picricum, Hydrastis, Iodium, Lycopodium, Nux vom., Pareira, Pulsatilla, Sabal, Selenium, Staphysag., Thuja occ.,Trifolium pratense, Echinacea, Lappa, Solidago PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARCTIUM LAPPA ROOT; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHONDRODENDRON TOMENTOSUM ROOT; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; DIGITALIS; ECHINACEA, UNSPECIFIED; FERRIC PICRATE; GOLDENSEAL; IODINE; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SAW PALMETTO; SELENIUM; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER 3; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 15; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2244_63bceab0-3d1b-6a87-6ac5-7fc5fa909344 55714-2244 HUMAN OTC DRUG Nervousness - Anxiety Aconitum nap., Ambra, Anacardium orientale, Arg. nit., Asafoetida, Bryonia, Chamomilla, Cimicifuga, Coffea cruda, Cypripedium, Gelsemium, Hyoscyamus, Hypericum, Ignatia, Kali phos., Nux vom., Sambucus nig., Strychninum, Theridion, Valeriana, Passiflora LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMBERGRIS; ARABICA COFFEE BEAN; ASAFETIDA; BLACK COHOSH; BRYONIA ALBA ROOT; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; SAMBUCUS NIGRA FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; STRYCHNINE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2245_fde69292-2a85-c035-981f-45217f046f42 55714-2245 HUMAN OTC DRUG Nervousness - Anxiety Aconitum nap., Ambra, Anacardium orientale, Arg. nit., Asafoetida, Bryonia, Chamomilla, Cimicifuga, Coffea cruda, Cypripedium, Gelsemium, Hyoscyamus, Hypericum, Ignatia, Kali phos., Nux vom., Sambucus nig., Strychninum, Theridion, Valeriana, Passiflora PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMBERGRIS; ARABICA COFFEE BEAN; ASAFETIDA; BLACK COHOSH; BRYONIA ALBA ROOT; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; SAMBUCUS NIGRA FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; STRYCHNINE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2246_14fce4e1-6dbf-367f-4968-ab8eb931c117 55714-2246 HUMAN OTC DRUG Insomnia Absinthium, Anacardium orientale, Arg. nit., Arsenicum alb., Belladonna, Bryonia, Calc. carb., Camphora, Chamomilla, Cimicifuga, Cinchona, Coffea cruda, Cypripedium, Gelsemium, Humulus, Hyoscyamus, Ignatia, Kali brom., Nux vom., Passiflora, Pulsatilla, Scutellaria lateriflora, Sepia, Thuja occ., Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HOPS; HYOSCYAMUS NIGER; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM BROMIDE; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VALERIAN; WORMWOOD 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2247_ebf5c137-63c5-a23c-cf2d-cd20bac254b1 55714-2247 HUMAN OTC DRUG Insomnia Absinthium, Anacardium orientale, Arg. nit., Arsenicum alb., Belladonna, Bryonia, Calc. carb., Camphora, Chamomilla, Cimicifuga, Cinchona, Coffea cruda, Cypripedium, Gelsemium, Humulus, Hyoscyamus, Ignatia, Kali brom., Nux vom., Passiflora, Pulsatilla, Scutellaria lateriflora, Sepia, Thuja occ., Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HOPS; HYOSCYAMUS NIGER; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM BROMIDE; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VALERIAN; WORMWOOD 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2248_54cbb3c6-c697-04da-42bf-14f3996e6172 55714-2248 HUMAN OTC DRUG Throat Care Aconitum nap., Apis mel., Arum dracontium, Belladonna, Bryonia, Cajuputum, Ferrum phosphoricum, Glycyrrhiza glabra, Kali bic., Lachesis, Mentha piperita, Merc. viv., Naja, Nat. carb., Nat. sulphuricum, Nitricum ac., Nux vom., Phosphorus, Phytolacca, Pulsatilla, Spongia, Stannum met., Sticta, Thuja occ., Ulmus fulva, Verbascum, Echinacea LIQUID ORAL 20110303 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARISAEMA DRACONTIUM ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAJUPUT OIL; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GLYCYRRHIZA GLABRA; LACHESIS MUTA VENOM; LOBARIA PULMONARIA; MENTHA PIPERITA; MERCURY; NAJA NAJA VENOM; NITRIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SODIUM CARBONATE; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TIN; ULMUS RUBRA BARK; VERBASCUM THAPSUS 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2249_4e6cf33f-eedd-b1b0-c10a-72035358ef28 55714-2249 HUMAN OTC DRUG Throat Care Aconitum nap., Apis mel., Arum dracontium, Belladonna, Bryonia, Cajuputum, Ferrum phosphoricum, Glycyrrhiza glabra, Kali bic., Lachesis, Mentha piperita, Merc. viv., Naja, Nat. carb., Nat. sulphuricum, Nitricum ac., Nux vom., Phosphorus, Phytolacca, Pulsatilla, Spongia, Stannum met., Sticta, Thuja occ., Ulmus fulva, Verbascum, Echinacea PELLET ORAL 20110303 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARISAEMA DRACONTIUM ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAJUPUT OIL; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GLYCYRRHIZA GLABRA; LACHESIS MUTA VENOM; LOBARIA PULMONARIA; MENTHA PIPERITA; MERCURY; NAJA NAJA VENOM; NITRIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SODIUM CARBONATE; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TIN; ULMUS RUBRA BARK; VERBASCUM THAPSUS 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2252_e9867b75-dd1a-6040-ecaf-c58617cb5d03 55714-2252 HUMAN OTC DRUG Appetite - Craving Control Anacardium orientale, Antimon.crud., Arg. nit., Berber. vulg., Bryonia, Chelidonium majus, Digitalis, Graphites, Humulus,Iris versicolor, Kali carb., Lycopodium, Nat. carb.,Nat. sulphuricum, Nux vom., Pulsatilla, Rhus. toxicodendron, Scutellaria lateriflora, Sepia,Stramonium, Chamomilla, Passiflora, Valeriana. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DATURA STRAMONIUM; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2253_7887f3df-b389-a333-6deb-d0c6548b7493 55714-2253 HUMAN OTC DRUG Appetite - Craving Control Anacardium orientale, Antimon.crud., Arg. nit., Berber. vulg., Bryonia, Chelidonium majus, Digitalis, Graphites, Humulus,Iris versicolor, Kali carb., Lycopodium, Nat. carb.,Nat. sulphuricum, Nux vom., Pulsatilla, Rhus. toxicodendron, Scutellaria lateriflora, Sepia,Stramonium, Chamomilla, Passiflora, Valeriana. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DATURA STRAMONIUM; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2254_92ac3ce6-b0c7-9b83-0fba-3581bbf655b0 55714-2254 HUMAN OTC DRUG Poison Ivy Xerophyllum asphodeloides, Aconitum nap., Anacardium orientale, Apis mel., Bryonia, Cantharis, Croton, Graphites, Grindelia, Mezereum, Nux vom., Ranunc. bulb., Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp.,Taraxacum, Urtica ur. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; BRYONIA ALBA ROOT; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GRAPHITE; GRINDELIA HIRSUTULA FLOWERING TOP; LYTTA VESICATORIA; RANUNCULUS BULBOSUS; RUMEX CRISPUS ROOT; SEMECARPUS ANACARDIUM JUICE; SMILAX REGELII ROOT; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; URTICA URENS; XEROPHYLLUM ASPHODELOIDES 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2256_e698afca-a5b5-aa31-164f-022c2f8da43f 55714-2256 HUMAN OTC DRUG Bowel - Digestive Care Bismuthum metallicum, Antimon.crud., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Chamomilla, Cinchona, Iris versicolor, Kali bic., Lachesis, Lycopodium, Mag. carb., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Raphanus, Rhus toxicodendron, Tabacum, Verbascum, Zingiber, Echinacea, Juglans regia. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT; GINGER; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; PHOSPHORUS; PODOPHYLLUM; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RADISH; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 10; 10; 10; 15; 10; 10; 3; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2257_4add2b49-4c76-43ce-67d6-01aab80fd287 55714-2257 HUMAN OTC DRUG Bowel - Digestive Care Bismuthum metallicum, Antimon.crud., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Chamomilla, Cinchona, Iris versicolor, Kali bic., Lachesis, Lycopodium, Mag. carb., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Raphanus, Rhus toxicodendron, Tabacum, Verbascum, Zingiber, Echinacea, Juglans regia. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT; GINGER; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; PHOSPHORUS; PODOPHYLLUM; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RADISH; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 10; 10; 10; 15; 10; 10; 3; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_M]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2258_63d6eecb-eb2e-5487-a57d-6e51a81925ea 55714-2258 HUMAN OTC DRUG Tobacco Withdrawal Arsenicum alb., Benzoicum acidum, Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Daphne indica, Ignatia, Iris versicolor, Lycopodium, Nicotinum, Nux vom., Rhus toxicodendron, Scutellaria lateriflora, Tabacum, Echinacea, Taraxacum, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DAPHNE ODORA BARK; DIEFFENBACHIA SEGUINE; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; NICOTINE; SCUTELLARIA LATERIFLORA; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2259_a092e2c4-a6dc-bda6-da7b-e43669d798d9 55714-2259 HUMAN OTC DRUG Tobacco Withdrawal Arsenicum alb., Benzoicum acidum, Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Daphne indica, Ignatia, Iris versicolor, Lycopodium, Nicotinum, Nux vom., Rhus toxicodendron, Scutellaria lateriflora, Tabacum, Echinacea, Taraxacum, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DAPHNE ODORA BARK; DIEFFENBACHIA SEGUINE; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; NICOTINE; SCUTELLARIA LATERIFLORA; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2260_8b4a6e20-7eb5-fb4b-9fcd-0b92df8698c8 55714-2260 HUMAN OTC DRUG Diarrhea Pyrogenium, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Carbo veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris versicolor, Lycopodium, Podoph. pelt., Raphanus, Tabacum, Vaccinium, Zingiber, Aesculus hipp., Juglans regia LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BILBERRY; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COLLINSONIA CANADENSIS ROOT; ECBALLIUM ELATERIUM FRUIT; ENGLISH WALNUT; GELSEMIUM SEMPERVIRENS ROOT; GINGER; HORSE CHESTNUT; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PODOPHYLLUM; RADISH; RANCID BEEF; SILVER NITRATE; TOBACCO LEAF 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 30; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2261_10213dda-f751-bf0f-458c-e0181f1745cb 55714-2261 HUMAN OTC DRUG Diarrhea Pyrogenium, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Carbo veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris versicolor, Lycopodium, Podoph. pelt., Raphanus, Tabacum, Vaccinium, Zingiber, Aesculus hipp., Juglans regia PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BILBERRY; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COLLINSONIA CANADENSIS ROOT; ECBALLIUM ELATERIUM FRUIT; ENGLISH WALNUT; GELSEMIUM SEMPERVIRENS ROOT; GINGER; HORSE CHESTNUT; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PODOPHYLLUM; RADISH; RANCID BEEF; SILVER NITRATE; TOBACCO LEAF 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 30; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2262_7daea221-e01f-84f5-02ca-05c4de9c3e61 55714-2262 HUMAN OTC DRUG Stage Fright - Fear Aconitum nap., Anacardium orientale, Arg. nit., Arsenicum alb., Cypripedium, Gelsemium, Ignatia, Kali carb., Lycopodium, Nat.mur., Phosphorus, Sambucus nig., Sepia, Staphysag., Stramonium, Tarentula hispana, Theridion, Passiflora, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; CYPRIPEDIUM PARVIFOLUM ROOT; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; POTASSIUM CARBONATE; SAMBUCUS NIGRA FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THERIDION CURASSAVICUM; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2263_0b61c5ca-b8f8-c8f8-080b-93130f8546ea 55714-2263 HUMAN OTC DRUG Stage Fright - Fear Aconitum nap., Anacardium orientale, Arg. nit., Arsenicum alb., Cypripedium, Gelsemium, Ignatia, Kali carb., Lycopodium, Nat.mur., Phosphorus, Sambucus nig., Sepia, Staphysag., Stramonium, Tarentula hispana, Theridion, Passiflora, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; CYPRIPEDIUM PARVIFOLUM ROOT; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; POTASSIUM CARBONATE; SAMBUCUS NIGRA FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THERIDION CURASSAVICUM; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2264_196a99e0-7404-edd7-13ba-d764e4c74eee 55714-2264 HUMAN OTC DRUG Libido Agnus, Aralia quinquefolia, Baryta carb., Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Causticum, Chelidonium majus, Cinchona, Conium, Gaultheria procumbens, Graphites, Kali carb., Lycopodium, Nux vom., Onosmodium virginianum, Phosphorus, Sabal, Selenium, Sepia, Silicea, Staphysag., Hydrastis, Thuja occ LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMERICAN GINSENG; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CAUSTICUM; CHASTE TREE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; GAULTHERIA PROCUMBENS TOP; GOLDENSEAL; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORUS; POTASSIUM CARBONATE; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2265_56ccf59f-6d2b-e071-a9ad-5d4e1bc88eb8 55714-2265 HUMAN OTC DRUG Libido Agnus, Aralia quinquefolia, Baryta carb., Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Causticum, Chelidonium majus, Cinchona, Conium, Gaultheria procumbens, Graphites, Kali carb., Lycopodium, Nux vom., Onosmodium virginianum, Phosphorus, Sabal, Selenium, Sepia, Silicea, Staphysag., Hydrastis, Thuja occ PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMERICAN GINSENG; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CAUSTICUM; CHASTE TREE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; GAULTHERIA PROCUMBENS TOP; GOLDENSEAL; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORUS; POTASSIUM CARBONATE; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2266_f6fb6d21-7f9f-dccb-4fc5-249a4da4d3ec 55714-2266 HUMAN OTC DRUG Accident - Injury Rescue Aconitum nap, Arnica, Bellis, Calendula, Echinacea, Gelsemium, Hamamelis, Hypericum, Ledum, Phosphorus, Rhus toxicodendron, Ruta, Staphysag., Symphytum, Hydrastis canadensis. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2267_4446bf7a-f4d8-1cf8-75f3-338cbb5b8678 55714-2267 HUMAN OTC DRUG Accident - Injury Rescue Aconitum nap, Arnica, Bellis, Calendula, Echinacea, Gelsemium, Hamamelis, Hypericum, Ledum, Phosphorus, Rhus toxicodendron, Ruta, Staphysag., Symphytum, Hydrastis canadensis. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2268_a73f4330-cb7f-fd0d-c198-57dbb3c66277 55714-2268 HUMAN OTC DRUG Blues - Mood Support Angelica sinensis radix, Aralia quinquefolia, Arg. nit., Arsenicum alb., Berber. aqui., Capsicum , Cinchona, Digitalis, Gelsemium, Hypericum, Ignatia, Iodium, Kali brom., Kali carb., Mag. phos., Nat. carb., Nat. mur., Phosphorus, Salix nigra, Sanguinaria, Sepia, Stramonium, Echinacea, Ginkgo LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMERICAN GINSENG; ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; CAPSICUM; CINCHONA OFFICINALIS BARK; DATURA STRAMONIUM; DIGITALIS; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; HYPERICUM PERFORATUM; IODINE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MAHONIA AQUIFOLIUM ROOT BARK; PHOSPHORUS; POTASSIUM BROMIDE; POTASSIUM CARBONATE; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 10; 10; 10; 10; 10; 10; 10; 3; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2269_202a4229-9262-bf67-e55e-f27b40fe12b6 55714-2269 HUMAN OTC DRUG Blues - Mood Support Angelica sinensis radix, Aralia quinquefolia, Arg. nit., Arsenicum alb., Berber. aqui., Capsicum , Cinchona, Digitalis, Gelsemium, Hypericum, Ignatia, Iodium, Kali brom., Kali carb., Mag. phos., Nat. carb., Nat. mur., Phosphorus, Salix nigra, Sanguinaria, Sepia, Stramonium, Echinacea, Ginkgo PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMERICAN GINSENG; ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; CAPSICUM; CINCHONA OFFICINALIS BARK; DATURA STRAMONIUM; DIGITALIS; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; HYPERICUM PERFORATUM; IODINE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MAHONIA AQUIFOLIUM ROOT BARK; PHOSPHORUS; POTASSIUM BROMIDE; POTASSIUM CARBONATE; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 10; 10; 10; 10; 10; 10; 10; 3; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2270_b97cc613-e333-5b7f-10be-5b425f8bc84c 55714-2270 HUMAN OTC DRUG Warts - Moles - Skin Tags Antimon. crud., Bryonia, Calc.carb., Causticum, Dulcamara, Graphites, Lycopodium, Merc. sulph. rub., Nat. carb., Nitricum ac., Nux vom., Rhus toxicodendron, Sabina, Sepia, Silicea, Staphysag., Sulphur, Thuja occ., Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; BRYONIA ALBA ROOT; CAUSTICUM; DELPHINIUM STAPHISAGRIA SEED; GRAPHITE; JUNIPERUS SABINA LEAFY TWIG; LYCOPODIUM CLAVATUM SPORE; MERCURIC SULFIDE; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CARBONATE; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2271_093c4b61-749c-f7a8-2b52-ad59e88711c6 55714-2271 HUMAN OTC DRUG Warts - Moles - Skin Tags Antimon. crud., Bryonia, Calc.carb., Causticum, Dulcamara, Graphites, Lycopodium, Merc. sulph. rub., Nat. carb., Nitricum ac., Nux vom., Rhus toxicodendron, Sabina, Sepia, Silicea, Staphysag., Sulphur, Thuja occ., Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; BRYONIA ALBA ROOT; CAUSTICUM; DELPHINIUM STAPHISAGRIA SEED; GRAPHITE; JUNIPERUS SABINA LEAFY TWIG; LYCOPODIUM CLAVATUM SPORE; MERCURIC SULFIDE; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CARBONATE; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2272_90041aed-d378-6ea0-0b3c-7753ba045623 55714-2272 HUMAN OTC DRUG Muscle Ease Aconitum nap., Antimon. tart.,Arg. nit., Arnica, Bryonia, Chamomilla,Chelidonium majus, Cimicifuga, Eupatorium perf.,Hypericum, Nux vom., Rhus toxicodendron, Ruta,Sarcolacticum ac., Stramonium, Strychninum,Chamomilla, Phytolacca, Ruta, Symphytum. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BLACK COHOSH; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COMFREY ROOT; DATURA STRAMONIUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; HYPERICUM PERFORATUM; LACTIC ACID, L-; MATRICARIA RECUTITA; MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE; STRYCHNINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 3; 3; 15; 3; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2273_64f7bb72-b361-483a-0ebf-c2a336ee2742 55714-2273 HUMAN OTC DRUG Muscle Ease Aconitum nap., Antimon. tart.,Arg. nit., Arnica, Bryonia, Chamomilla,Chelidonium majus, Cimicifuga, Eupatorium perf.,Hypericum, Nux vom., Rhus toxicodendron, Ruta,Sarcolacticum ac., Stramonium, Strychninum,Chamomilla, Phytolacca, Ruta, Symphytum. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BLACK COHOSH; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COMFREY ROOT; DATURA STRAMONIUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; HYPERICUM PERFORATUM; LACTIC ACID, L-; MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE; STRYCHNINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2274_254ae2c4-5707-f56d-5175-12cc8e93442a 55714-2274 HUMAN OTC DRUG Bug Bites - Itch Stopper Pyrogenium, Apis mel., Aranea diadema, Arnica, Arsenicum alb., Azadirachta indica, Bryonia, Caladium seguinum, Calendula, Formica, Grindelia, Hypericum, Lachesis, Latrodectus mactans, Ledum, Mezereum, Nux vom., Pulex irritans, Rhus toxicodendron, Tarentula cubensis, Tarentula hispana, Theridion, Thuja occ., Vespa crabro, Echinacea, Hamamelis, Solidago LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARANEUS DIADEMATUS; ARNICA MONTANA; ARSENIC TRIOXIDE; AZADIRACHTA INDICA BARK; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CITHARACANTHUS SPINICRUS; DAPHNE MEZEREUM BARK; DIEFFENBACHIA SEGUINE; ECHINACEA, UNSPECIFIED; FORMICA RUFA; GRINDELIA HIRSUTULA FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; LYCOSA TARANTULA; PULEX IRRITANS; RANCID BEEF; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; VESPA CRABRO 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 30; 3; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2275_da159cbd-50d9-a529-fd44-f595bd34f9d5 55714-2275 HUMAN OTC DRUG Bug Bites - Itch Stopper Pyrogenium, Apis mel., Aranea diadema, Arnica, Arsenicum alb., Azadirachta indica, Bryonia, Caladium seguinum, Calendula, Formica, Grindelia, Hypericum, Lachesis, Latrodectus mactans, Ledum, Mezereum, Nux vom., Pulex irritans, Rhus toxicodendron, Tarentula cubensis, Tarentula hispana, Theridion, Thuja occ., Vespa crabro, Echinacea, Hamamelis, Solidago PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARANEUS DIADEMATUS; ARNICA MONTANA; ARSENIC TRIOXIDE; AZADIRACHTA INDICA BARK; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CITHARACANTHUS SPINICRUS; DAPHNE MEZEREUM BARK; DIEFFENBACHIA SEGUINE; ECHINACEA, UNSPECIFIED; FORMICA RUFA; GRINDELIA HIRSUTULA FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; LYCOSA TARANTULA; PULEX IRRITANS; RANCID BEEF; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; VESPA CRABRO 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 30; 3; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2276_8d6c7169-b7d4-0d60-6558-97efb8c7d680 55714-2276 HUMAN OTC DRUG Cold Sores Arsenicum alb., Bryonia, Cantharis, Chelidonium majus, Cistus canadensis, Conium, Croton, Dulcamara, Graphites, Kali bic., Lycopodium, Mezereum, Nux vom., Petroleum, Pulsatilla, Ranunc. bulb., Rhus toxicodendron, Sarsaparilla, Sepia, Sulphur, Thuja occ., Echinacea, Hypericum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GRAPHITE; HELIANTHEMUM CANADENSE; HYPERICUM PERFORATUM; KEROSENE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUICE; SMILAX REGELII ROOT; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 3; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2277_cc0a55eb-6c5d-997d-0ddf-58cdb956fe39 55714-2277 HUMAN OTC DRUG Cold Sores Arsenicum alb., Bryonia, Cantharis, Chelidonium majus, Cistus canadensis, Conium, Croton, Dulcamara, Graphites, Kali bic., Lycopodium, Mezereum, Nux vom., Petroleum, Pulsatilla, Ranunc. bulb., Rhus toxicodendron, Sarsaparilla, Sepia, Sulphur, Thuja occ., Echinacea, Hypericum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GRAPHITE; HELIANTHEMUM CANADENSE; HYPERICUM PERFORATUM; KEROSENE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUICE; SMILAX REGELII ROOT; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 3; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2278_137d0005-78bb-8b9a-a2d6-f67b0f073196 55714-2278 HUMAN OTC DRUG Caffeine Withdrawal Aconitum nap., Arg. nit., Arsenicum alb., Belladonna, Benzoicum acidum, Berber. vulg., Bryonia, Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Coffea cruda, Conium, Gelsemium, Ignatia, Iris versicolor, Mezereum, Nux vom., Passiflora, Pulsatilla, Rhus toxicodendron, Scutellaria lateriflora, Staphysag., Chamomilla, Taraxacum, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DAPHNE MEZEREUM BARK; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; SILVER NITRATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 3; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2279_ba2bda92-9158-d59b-1160-0b222c9f6527 55714-2279 HUMAN OTC DRUG Caffeine Withdrawal Aconitum nap., Arg. nit., Arsenicum alb., Belladonna, Benzoicum acidum, Berber. vulg., Bryonia, Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Coffea cruda, Conium, Gelsemium, Ignatia, Iris versicolor, Mezereum, Nux vom., Passiflora, Pulsatilla, Rhus toxicodendron, Scutellaria lateriflora, Staphysag., Chamomilla, Taraxacum, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DAPHNE MEZEREUM BARK; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; SILVER NITRATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 3; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2280_db6355a8-478f-3bd5-22c7-73b88eace0c7 55714-2280 HUMAN OTC DRUG Eye Care Aconitum nap., Allium cepa, Arsenicum alb., Bryonia, Calendula, Chelidonium majus, Cineraria, Euphrasia, Graphites, Lycopodium, Merc. corros., Nux vom., Phosphorus, Phytolacca, Picricum ac., Pulsatilla, Rhus toxicodendron, Sulphur, Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; GRAPHITE; JACOBAEA MARITIMA; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; ONION; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; TRINITROPHENOL 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2281_0cdaae06-82bf-8134-8429-43d7924346c5 55714-2281 HUMAN OTC DRUG Eye Care Aconitum nap., Allium cepa, Arsenicum alb., Bryonia, Calendula, Chelidonium majus, Cineraria, Euphrasia, Graphites, Lycopodium, Merc. corros., Nux vom., Phosphorus, Phytolacca, Picricum ac., Pulsatilla, Rhus toxicodendron, Sulphur, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; GRAPHITE; JACOBAEA MARITIMA; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; ONION; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; TRINITROPHENOL 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2282_26bb8fdc-df6f-d2f7-0482-c007c3558335 55714-2282 HUMAN OTC DRUG Teeth - Gums Aconitum nap., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium majus, Crotalus horridus, Gelsemium, Hepar sulph. calc., Kreosotum, Merc. viv., Myrrha, Nux vom., Phosphorus, Phytolacca, Plantago, Rhus toxicodendron, Silicea, Staphysag., Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA RECUTITA; MERCURY; MYRRH; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; WOOD CREOSOTE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2283_09793a85-57fc-21ef-624c-5755a13d8bb6 55714-2283 HUMAN OTC DRUG Teeth - Gums Aconitum nap., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium majus, Crotalus horridus, Gelsemium, Hepar sulph. calc., Kreosotum, Merc. viv., Myrrha, Nux vom., Phosphorus, Phytolacca, Plantago, Rhus toxicodendron, Silicea, Staphysag., Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA RECUTITA; MERCURY; MYRRH; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; WOOD CREOSOTE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2284_09574572-27ff-dcdf-b5b3-3fc8baa481ec 55714-2284 HUMAN OTC DRUG Hives - Rashes Antimon. crud., Apis mel., Arsenicum alb., Berber. vulg., Bovista, Bryonia, Cantharis, Chelidonium majus, Croton, Dulcamara, Graphites, Histaminum hydrochloricum, Lycopodium, Mezereum, Nux vom., Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp., Taraxacum, Urtica ur. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GIANT PUFFBALL; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; KEROSENE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PULEX IRRITANS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SMILAX REGELII ROOT; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2285_b8fc2c22-2a8a-2815-9bbd-cdb4bed61833 55714-2285 HUMAN OTC DRUG Hives - Rashes Antimon. crud., Apis mel., Arsenicum alb., Berber. vulg., Bovista, Bryonia, Cantharis, Chelidonium majus, Croton, Dulcamara, Graphites, Histaminum hydrochloricum, Lycopodium, Mezereum, Nux vom., Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp., Taraxacum, Urtica ur. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GIANT PUFFBALL; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; KEROSENE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PULEX IRRITANS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SMILAX REGELII ROOT; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2286_f1c3d3a2-259d-4e89-0b9b-e159bacf90e2 55714-2286 HUMAN OTC DRUG Incontinence Aloe, Arg. nit., Arsenicum alb., Belladonna, Benzoicum acidum, Bryonia, Cantharis, Causticum, Equisetum hyemale, Ferrum metallicum, Gelsemium, Ignatia, Kali phos., Lycopodium, Nat. mur., Nitricum ac., Plantago, Pulsatilla, Rhus aromatica , Sabal, Secale, Sepia, Staphysag.,Stramonium, Thyroidinum, Verbascum, Echinacea, Hydrastis LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BRYONIA ALBA ROOT; CAUSTICUM; CLAVICEPS PURPUREA SCLEROTIUM; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; EQUISETUM HYEMALE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; IRON; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; NITRIC ACID; PLANTAGO MAJOR; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; RHUS AROMATICA ROOT BARK; SAW PALMETTO; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THYROID, UNSPECIFIED; VERBASCUM THAPSUS 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2287_8f52db34-78ea-1c28-0fc9-f942ce974760 55714-2287 HUMAN OTC DRUG Incontinence Aloe, Arg. nit., Arsenicum alb., Belladonna, Benzoicum acidum, Bryonia, Cantharis, Causticum, Equisetum hyemale, Ferrum metallicum, Gelsemium, Ignatia, Kali phos., Lycopodium, Nat. mur., Nitricum ac., Plantago, Pulsatilla, Rhus aromatica , Sabal, Secale, Sepia, Staphysag.,Stramonium, Thyroidinum, Verbascum, Echinacea, Hydrastis PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BRYONIA ALBA ROOT; CAUSTICUM; CLAVICEPS PURPUREA SCLEROTIUM; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; EQUISETUM HYEMALE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; IRON; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; NITRIC ACID; PLANTAGO MAJOR; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; RHUS AROMATICA ROOT BARK; SAW PALMETTO; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THYROID, UNSPECIFIED; VERBASCUM THAPSUS 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2288_507e4e0b-2547-9597-999d-98db06b82d23 55714-2288 HUMAN OTC DRUG Motion Sickness Absinthium, Aconitum nap., Antimon. tart., Belladonna, Bryonia, Carbolicum acidum, Colchicum, Conium, Ferrum metallicum, Gelsemium, Glonoinum, Hyoscyamus, Ipecac., Iris versicolor, Lycopodium, Nux vom., Petroleum, Phosphorus, Sepia, Symphoricarpus racemosus, Tabacum, Theridion, Zingiber, Echinacea, Hypericum, Passiflora, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GINGER; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; IPECAC; IRIS VERSICOLOR ROOT; IRON; KEROSENE; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; PASSIFLORA INCARNATA FLOWERING TOP; PHENOL; PHOSPHORUS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SYMPHORICARPOS ALBUS FRUIT; THERIDION CURASSAVICUM; TOBACCO LEAF; VALERIAN; WORMWOOD 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2289_ac0e970b-03d4-dd60-f39a-0b9a19de3a18 55714-2289 HUMAN OTC DRUG Motion Sickness Absinthium, Aconitum nap., Antimon. tart., Belladonna, Bryonia, Carbolicum acidum, Colchicum, Conium, Ferrum metallicum, Gelsemium, Glonoinum, Hyoscyamus, Ipecac., Iris versicolor, Lycopodium, Nux vom., Petroleum, Phosphorus, Sepia, Symphoricarpus racemosus, Tabacum, Theridion, Zingiber, Echinacea, Hypericum, Passiflora, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GINGER; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; IPECAC; IRIS VERSICOLOR ROOT; IRON; KEROSENE; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; PASSIFLORA INCARNATA FLOWERING TOP; PHENOL; PHOSPHORUS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SYMPHORICARPOS ALBUS FRUIT; THERIDION CURASSAVICUM; TOBACCO LEAF; VALERIAN; WORMWOOD 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2290_f5d7bb39-9a7b-a131-79f9-6f57d3447a65 55714-2290 HUMAN OTC DRUG Feminine Comfort Agaricus musc., Arsenicum alb., Aur. met., Berber. aqui., Caladium seguinum, Candida albicans, Cantharis, Conium, Graphites, Helonias dioica, Hydrastis, Kali carb., Kreosotum, Lycopodium, Merc. viv., Murex purpurea, Nat. mur., Nitricum ac., Pulsatilla, Rhus toxicodendron, Sepia, Sulphur, Tarentula hispana, Thuja occ., Zinc. met., Apis mel., Hamamelis LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; APIS MELLIFERA; ARSENIC TRIOXIDE; CANDIDA ALBICANS; CHAMAELIRIUM LUTEUM ROOT; CONIUM MACULATUM FLOWERING TOP; DIEFFENBACHIA SEGUINE; GOLD; GOLDENSEAL; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; LYTTA VESICATORIA; MAHONIA AQUIFOLIUM ROOT BARK; MERCURY; NITRIC ACID; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; WOOD CREOSOTE; ZINC 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2291_5f855a16-a2cd-e5ff-4c19-4edfa96ac5cd 55714-2291 HUMAN OTC DRUG Feminine Comfort Agaricus musc., Arsenicum alb., Aur. met., Berber. aqui., Caladium seguinum, Candida albicans, Cantharis, Conium, Graphites, Helonias dioica, Hydrastis, Kali carb., Kreosotum, Lycopodium, Merc. viv., Murex purpurea, Nat. mur., Nitricum ac., Pulsatilla, Rhus toxicodendron, Sepia, Sulphur, Tarentula hispana, Thuja occ., Zinc. met., Apis mel., Hamamelis PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; APIS MELLIFERA; ARSENIC TRIOXIDE; CANDIDA ALBICANS; CHAMAELIRIUM LUTEUM ROOT; CONIUM MACULATUM FLOWERING TOP; DIEFFENBACHIA SEGUINE; GOLD; GOLDENSEAL; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; LYTTA VESICATORIA; MAHONIA AQUIFOLIUM ROOT BARK; MERCURY; NITRIC ACID; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; WOOD CREOSOTE; ZINC 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2292_1d06d506-7345-4abf-c075-0244a73742b2 55714-2292 HUMAN OTC DRUG Hair Scalp Apis mel., Arsenicum alb., Calc. carb., Dulcamara, Graphites, Hepar sulph. calc., Hydrastis, Hydrofluoricum acidum, Kali carb., Lycopodium, Mezereum, Oleander, Petroleum, Phosphoricum ac., Phosphorus, Rhus toxicodendron, Selenium, Sepia, Silicea, Sulphur, Hydrastis,Thuja occ. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; CALCIUM SULFIDE; DAPHNE MEZEREUM BARK; GOLDENSEAL; GRAPHITE; HYDROFLUORIC ACID; KEROSENE; LYCOPODIUM CLAVATUM SPORE; NERIUM OLEANDER LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM CARBONATE; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2293_7d9d64e3-6f89-468b-99d8-96a4d08905b5 55714-2293 HUMAN OTC DRUG Hair Scalp Apis mel., Arsenicum alb., Calc. carb., Dulcamara, Graphites, Hepar sulph. calc., Hydrastis, Hydrofluoricum acidum, Kali carb., Lycopodium, Mezereum, Oleander, Petroleum, Phosphoricum ac., Phosphorus, Rhus toxicodendron, Selenium, Sepia, Silicea, Sulphur, Thuja occ. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; CALCIUM SULFIDE; DAPHNE MEZEREUM BARK; GOLDENSEAL; GRAPHITE; HYDROFLUORIC ACID; KEROSENE; LYCOPODIUM CLAVATUM SPORE; NERIUM OLEANDER LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM CARBONATE; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2294_60d44f14-0b8c-71cd-b2fc-72f33ef2dfd8 55714-2294 HUMAN OTC DRUG Leg Cramps - Swelling Elaps corallinus, Arg. nit., Bryonia, Calc. carb., Colocynthis, Convallaria, Crotalus horridus, Cuprum met., Digitalis, Gelsemium, Hypericum, Kali carb., Lachesis, Lathyrus sativus, Lilium, Mag. phos., Nux vom., Rhus toxicodendron, Silicea, Stramonium, Veratrum viride, Echinacea LIQUID ORAL 20120301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BRYONIA ALBA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CONVALLARIA MAJALIS; COPPER; CROTALUS HORRIDUS HORRIDUS VENOM; DATURA STRAMONIUM; DIGITALIS; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATHYRUS SATIVAS SEED; LILIUM LANCIFOLIUM WHOLE FLOWERING; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MICRURUS CORALLINUS VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; SILICON DIOXIDE; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VERATRUM VIRIDE ROOT 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2295_845c979e-a9fc-9f1f-20d7-70cbed00044f 55714-2295 HUMAN OTC DRUG Leg Cramps - Swelling Elaps corallinus, Arg. nit., Bryonia, Calc. carb., Colocynthis, Convallaria, Crotalus horridus, Cuprum met., Digitalis, Gelsemium, Hypericum, Kali carb., Lachesis, Lathyrus sativus, Lilium, Mag. phos., Nux vom., Rhus toxicodendron, Silicea, Stramonium, Veratrum viride, Echinacea PELLET ORAL 20120301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BRYONIA ALBA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CONVALLARIA MAJALIS; COPPER; CROTALUS HORRIDUS HORRIDUS VENOM; DATURA STRAMONIUM; DIGITALIS; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATHYRUS SATIVAS SEED; LILIUM LANCIFOLIUM WHOLE FLOWERING; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MICRURUS CORALLINUS VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; SILICON DIOXIDE; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VERATRUM VIRIDE ROOT 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2296_745542e3-7a69-de04-cd8d-5f45496c57f8 55714-2296 HUMAN OTC DRUG Sciatica - Nerve Care Aconitum nap., Ammonium benzoicum, Arsenicum alb., Benzoicum acidum, Bryonia, Causticum, Cinchona, Colchicum, Gnaphalium polycephalum, Iris versicolor, Kali iod., Ledum, Lithium carb., Nux vom., Phytolacca, Rhus toxicodendron, Ruta, Sambucus nig., Strychninum, Hypericum, Urtica ur. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMMONIUM BENZOATE; ARSENIC TRIOXIDE; BENZOIC ACID; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; HYPERICUM PERFORATUM; IRIS VERSICOLOR ROOT; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; PHYTOLACCA AMERICANA ROOT; POTASSIUM IODIDE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2297_a73d4136-fab5-4280-8141-4eb9c02a347d 55714-2297 HUMAN OTC DRUG Sciatica - Nerve Care Aconitum nap., Ammonium benzoicum, Arsenicum alb., Benzoicum acidum, Bryonia, Causticum, Cinchona, Colchicum, Gnaphalium polycephalum, Iris versicolor, Kali iod., Ledum, Lithium carb., Nux vom., Phytolacca, Rhus toxicoderon, Ruta, Sambucus nig., Strychninum, Hypericum, Urtica ur PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMMONIUM BENZOATE; ARSENIC TRIOXIDE; BENZOIC ACID; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; HYPERICUM PERFORATUM; IRIS VERSICOLOR ROOT; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; PHYTOLACCA AMERICANA ROOT; POTASSIUM IODIDE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2298_755677a5-0b26-9fe5-8de4-27b6cad38ba3 55714-2298 HUMAN OTC DRUG Fatigue Fighter Aconitum nap., Adrenalinum, Aralia quinquefolia, Arnica, Arsenicum alb., Baptisia, Bryonia, Cantharis, Chelidonium majus, Cinchona, Iodium, Kali carb., Kali iod., Lachesis, Lycopodium, Lycopus virginicus, Nat. mur., Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabal, Thyroidinum, Echinacea, Gingko, Phytolacca. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GINKGO; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; LYTTA VESICATORIA; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; SAW PALMETTO; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 3; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2299_7c57ff22-b388-15a2-8010-de1da5b41c8d 55714-2299 HUMAN OTC DRUG Fatigue Fighter Aconitum nap., Adrenalinum, Aralia quinquefolia, Arnica, Arsenicum alb., Baptisia, Bryonia, Cantharis, Chelidonium majus, Cinchona, Iodium, Kali carb., Kali iod., Lachesis, Lycopodium, Lycopus virginicus, Nat. mur., Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabal, Thyroidinum, Echinacea, Gingko, Phytolacca. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GINKGO; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; LYTTA VESICATORIA; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; SAW PALMETTO; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 3; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2300_41d6bd3a-64f7-2c4f-db39-e8287a49badd 55714-2300 HUMAN OTC DRUG Inflammation Anthracinum, Pyrogenium, Aconitum nap., Aloe, Apis mel., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chelidonium majus, Crotalus horridus, Ferrum phosphoricum, Gaultheria procumbens, Hepar sulph. calc., Iodium, Lachesis, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Veratrum viride, Verbascum, Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALOE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GAULTHERIA PROCUMBENS TOP; IODINE; LACHESIS MUTA VENOM; LYTTA VESICATORIA; PHOSPHORUS; PULSATILLA VULGARIS; RANCID BEEF; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VERATRUM VIRIDE ROOT; VERBASCUM THAPSUS 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2301_209d2d0b-d89f-d407-1569-46f6a88f5ae3 55714-2301 HUMAN OTC DRUG Inflammation Anthracinum, Pyrogenium, Aconitum nap., Aloe, Apis mel., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chelidonium majus, Crotalus horridus, Ferrum phosphoricum, Gaultheria procumbens, Hepar sulph. calc., Iodium, Lachesis, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Veratrum viride, Verbascum, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALOE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GAULTHERIA PROCUMBENS TOP; IODINE; LACHESIS MUTA VENOM; LYTTA VESICATORIA; PHOSPHORUS; PULSATILLA VULGARIS; RANCID BEEF; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VERATRUM VIRIDE ROOT; VERBASCUM THAPSUS 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2302_dd82deb6-055c-7741-6ea2-97892f2c53cd 55714-2302 HUMAN OTC DRUG Cold Hands - Feet Histaminum hydrochloricum,Thyroidinum, Aconitum nap., Arsenicum alb., Bryonia, Cactus, Calc. fluor., Ceanothus, Cinchona, Convallaria, Digitalis, Gelsemium, Glonoinum, Hydrocoyle, Kali carb., Lachesis, Naja, nat carb., Nat mur., Nux vom., Phosphorus, Pullsatilla, Rhus toxicodendron, Strophanthus hispidus, Sulphur, Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CEANOTHUS AMERICANUS LEAF; CENTELLA ASIATICA; CINCHONA OFFICINALIS BARK; CONVALLARIA MAJALIS; DIGITALIS; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; LACHESIS MUTA VENOM; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SELENICEREUS GRANDIFLORUS STEM; SODIUM CARBONATE; SODIUM CHLORIDE; STROPHANTHUS HISPIDUS SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2303_c53cdda7-96d8-ee85-68ac-86d0756eb54e 55714-2303 HUMAN OTC DRUG Cold Hands - Feet Histaminum hydrochloricum,Thyroidinum, Aconitum nap., Arsenicum alb., Bryonia, Cactus, Calc. fluor., Ceanothus, Cinchona, Convallaria, Digitalis, Gelsemium, Glonoinum, Hydrocoyle, Kali carb., Lachesis, Naja, nat carb., Nat mur., Nux vom., Phosphorus, Pullsatilla, Rhus toxicodendron, Strophanthus hispidus, Sulphur, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CEANOTHUS AMERICANUS LEAF; CENTELLA ASIATICA; CINCHONA OFFICINALIS BARK; CONVALLARIA MAJALIS; DIGITALIS; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; LACHESIS MUTA VENOM; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SELENICEREUS GRANDIFLORUS STEM; SODIUM CARBONATE; SODIUM CHLORIDE; STROPHANTHUS HISPIDUS SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2304_9bce009d-18fa-9bfd-e1b8-ccd9fd0fa3a7 55714-2304 HUMAN OTC DRUG Parasites Abrotanum, Aesculus hipp., Allium sativum, Arsenicum alb., Artemisia, Baptisia, Cina, Cuprum met., Filix mas, Granatum, Ipecac, Lachesis, Lycopodium, Merc. viv, Naphthalinum, Nat. mur., Nux vom., Pulsatilla, Ratanhia, Ruta, Sabadilla, Santoninum, Silicea, Spigelia anth., Terebinthina, Teucrium marum, Thymolum, Zingiber, Juglans regia LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; ARTEMISIA MARITIMA FLOWER; ARTEMISIA VULGARIS ROOT; BAPTISIA TINCTORIA; COPPER; DRYOPTERIS FILIX-MAS ROOT; ENGLISH WALNUT; GARLIC; GINGER; HORSE CHESTNUT; IPECAC; KRAMERIA LAPPACEA ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; NAPHTHALENE; PULSATILLA VULGARIS; PUNICA GRANATUM ROOT BARK; RUTA GRAVEOLENS FLOWERING TOP; SANTONIN; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM; THYMOL; TURPENTINE OIL 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2305_a03057fa-45b5-9c4e-a357-aba2d3d5b893 55714-2305 HUMAN OTC DRUG Parasites Abrotanum, Aesculus hipp., Allium sativum, Arsenicum alb., Artemisia, Baptisia, Cina, Cuprum met., Filix mas, Granatum, Ipecac, Lachesis, Lycopodium, Merc. viv, Naphthalinum, Nat. mur., Nux vom., Pulsatilla, Ratanhia, Ruta, Sabadilla, Santoninum, Silicea, Spigelia anth., Terebinthina, Teucrium marum, Thymolum, Zingiber, Juglans regia PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; ARTEMISIA MARITIMA FLOWER; ARTEMISIA VULGARIS ROOT; BAPTISIA TINCTORIA; COPPER; DRYOPTERIS FILIX-MAS ROOT; ENGLISH WALNUT; GARLIC; GINGER; HORSE CHESTNUT; IPECAC; KRAMERIA LAPPACEA ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; NAPHTHALENE; PULSATILLA VULGARIS; PUNICA GRANATUM ROOT BARK; RUTA GRAVEOLENS FLOWERING TOP; SANTONIN; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM; THYMOL; TURPENTINE OIL 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2306_8aa7f69b-a7be-de1a-d092-2a9dd6c184cf 55714-2306 HUMAN OTC DRUG Snore Soothe Histaminum hydrochloricum Laccaninum, Arsenicum alb., Belladonna Bryonia,Camphora, Cistus canadensis, Drosera, Hepar sulph.calc., Hydrastis, Ignatia, Iodium, Kali bic.,Kali iod., Nux vom., Phosphorus, Pulsatilla,Sabadilla, Silicea, Sticta, Sulphur, Teucriummarum, Verbascum, Echinacea. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAMPHOR (NATURAL); CANIS LUPUS FAMILIARIS MILK; DROSERA ROTUNDIFOLIA FLOWERING TOP; ECHINACEA, UNSPECIFIED; GOLDENSEAL; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; IODINE; LOBARIA PULMONARIA; PHOSPHORUS; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR; TEUCRIUM MARUM; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 15; 10; 3; 10; 10; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2307_62f4d3a0-8a5f-eb2c-0fe3-f9356e2a5ddb 55714-2307 HUMAN OTC DRUG Snore Soothe Histaminum hydrochloricum, Lac caninum, Arsenicum alb., Belladonna, Bryonia, Camphora, Cistus canadensis, Drosera, Hepar sulph.calc., Hydrastis, Ignatia, Iodium, Kali bic.,Kali iod., Nux vom., Phosphorus, Pulsatilla, Sabadilla, Silicea, Sticta, Sulphur, Teucrium marum, Verbascum, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAMPHOR (NATURAL); CANIS LUPUS FAMILIARIS MILK; DROSERA ROTUNDIFOLIA FLOWERING TOP; ECHINACEA, UNSPECIFIED; GOLDENSEAL; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; IODINE; LOBARIA PULMONARIA; PHOSPHORUS; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR; TEUCRIUM MARUM; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 15; 10; 3; 10; 10; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2309_0fadf26b-45bf-620b-cd13-1f31587c6487 55714-2309 HUMAN OTC DRUG Pollen Weeds Xerophyllum asphodeloides, Adrenalinum, Alfalfa, Aletris farinosa, Artemisia vulgaris, Bellis perennis, Dysphania ambrosioides, Lycopus virginicus, Phytolacca american root, Populus tremuloides, Ptelea trifoliata, Sambusus nigra, Trillium erectum root, Elymus repens root, Urtica urens, Wyethia helenioides, Yucca filamentosa, Avena sativa pollen, Cynosurus cristatus pollen. Echinochloa crus-galli pollen, Poa pratensis pollen, Anthoxanthum odoratum pollen, Agrostis gigantea pollen, Bromus secalinus pollen PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AGROSTIS GIGANTEA POLLEN; ALETRIS FARINOSA ROOT; ALFALFA; ALOPECURUS PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; AVENA SATIVA POLLEN; BAPTISIA TINCTORIA ROOT; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; BETULA PENDULA POLLEN; BROMUS SECALINUS POLLEN; BRYONIA ALBA ROOT; CALLUNA VULGARIS POLLEN; CHELIDONIUM MAJUS; CORYLUS AMERICANA POLLEN; CRATAEGUS MONOGYNA POLLEN; CYNOSURUS CRISTATUS POLLEN; CYTISUS SCOPARIUS POLLEN; DIANTHUS CARYOPHYLLUS FLOWER; DIOSCOREA VILLOSA TUBER; DYSPHANIA AMBROSIOIDES; ECHINOCHLOA CRUS-GALLI POLLEN; ELYMUS REPENS ROOT; EPINEPHRINE; EUPHRASIA STRICTA; FAGUS SYLVATICA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS EXCELSIOR POLLEN; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; HOLCUS LANATUS POLLEN; JUNIPERUS VIRGINIANA TWIG; LACHESIS MUTA VENOM; LILIUM CANDIDUM FLOWER; LOLIUM PERENNE POLLEN; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; NARCISSUS PSEUDONARCISSUS; ONION; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PLATANUS ORIENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS BALSAMIFERA LEAF BUD; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PRIMULA VULGARIS; PTELEA TRIFOLIATA BARK; PULSATILLA VULGARIS; QUERCUS ALBA POLLEN; ROSA CANINA FLOWER; SALIX ALBA POLLEN; SAMBUCUS NIGRA FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; TARAXACUM OFFICINALE; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER; TRILLIUM ERECTUM ROOT; ULEX EUROPAEUS FLOWER; ULMUS GLABRA POLLEN; URTICA URENS; USTILAGO MAYDIS; WYETHIA HELENIOIDES ROOT; XEROPHYLLUM ASPHODELOIDES; YUCCA FILAMENTOSA 15; 15; 15; 15; 15; 10; 10; 15; 15; 10; 15; 10; 15; 15; 10; 15; 10; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 10; 15; 15; 15; 10; 3; 3; 15; 15; 15; 10; 15; 15; 10; 15; 15; 10; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 15; 15; 10; 15; 15; 15; 15; 10; 3; 15; 15; 15; 15; 15; 15; 15; 15; 30; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2310_09bf43dc-58ab-2436-3e51-da74cf5b2179 55714-2310 HUMAN OTC DRUG Dust - Mold - Dander Felis catus skin, Canis lupus familiaris skin, Ortcyolagus cuniculus skin, Equus caballus skin, Serinus canaria feather, Gallus gallus feather, Anas platyrhynchos feather, Anser anser feather, Melopsittacus undulatus feather, Phasianus colchicus feather, Meleagris gallopavo feather, Felis catus hair, Human dander, Canis lupus familiaris hair, Equus caballus hair, Oryctolagus cuniculus hair, Human hair, Human skin, Sheep wool, Bos taurus hair, Capra hircus hair, Cavia porcellus hair LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; BAPTISIA TINCTORIA ROOT; BLATTA ORIENTALIS; BOS TAURUS HAIR; BROMINE; BRYONIA ALBA ROOT; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CANIS LUPUS FAMILIARIS SKIN; CAPRA HIRCUS HAIR; CAVIA PORCELLUS HAIR; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CLADOSPORIUM HERBARUM; EQUUS CABALLUS HAIR; EQUUS CABALLUS SKIN; FELIS CATUS HAIR; FELIS CATUS SKIN; GALLUS GALLUS FEATHER; HISTAMINE DIHYDROCHLORIDE; HOUSE DUST; HUMAN DANDER; HUMAN HAIR; HUMAN SKIN; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MELEAGRIS GALLOPAVO FEATHER; MELOPSITTACUS UNDULATUS FEATHER; MESOCRICETUS AURATUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; ORYCTOLAGUS CUNICULUS SKIN; PHASIANUS COLCHICUS FEATHER; PODOPHYLLUM; SACCHAROMYCES CEREVISIAE; SERINUS CANARIA FEATHER; SHEEP WOOL; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; USTILAGO MAYDIS; WHEAT GLUTEN 60; 60; 10; 10; 10; 15; 10; 10; 60; 10; 10; 15; 60; 60; 60; 60; 10; 10; 10; 15; 60; 60; 60; 60; 60; 15; 15; 60; 60; 60; 10; 3; 10; 60; 60; 60; 60; 60; 60; 10; 15; 60; 60; 10; 3; 10; 10; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2311_4877a63a-1508-6adb-8d42-f30033600d58 55714-2311 HUMAN OTC DRUG Dust - Mold - Dander Felis catus skin, Canis lupus familiaris skin, Ortcyolagus cuniculus skin, Equus caballus skin, Serinus canaria feather, Gallus gallus feather, Anas platyrhynchos feather, Anser anser feather, Melopsittacus undulatus feather, Phasianus colchicus feather, Meleagris gallopavo feather, Felis catus hair, Human dander, Canis lupus familiaris hair, Equus caballus hair, Oryctolagus cuniculus hair, Human hair, Human skin, Sheep wool, Bos taurus hair, Capra hircus hair, Cavia porcellus hair PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; BAPTISIA TINCTORIA ROOT; BLATTA ORIENTALIS; BOS TAURUS HAIR; BROMINE; BRYONIA ALBA ROOT; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CANIS LUPUS FAMILIARIS SKIN; CAPRA HIRCUS HAIR; CAVIA PORCELLUS HAIR; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CLADOSPORIUM HERBARUM; EQUUS CABALLUS HAIR; EQUUS CABALLUS SKIN; FELIS CATUS HAIR; FELIS CATUS SKIN; GALLUS GALLUS FEATHER; HISTAMINE DIHYDROCHLORIDE; HOUSE DUST; HUMAN DANDER; HUMAN HAIR; HUMAN SKIN; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MELEAGRIS GALLOPAVO FEATHER; MELOPSITTACUS UNDULATUS FEATHER; MESOCRICETUS AURATUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; ORYCTOLAGUS CUNICULUS SKIN; PHASIANUS COLCHICUS FEATHER; PODOPHYLLUM; SACCHAROMYCES CEREVISIAE; SERINUS CANARIA FEATHER; SHEEP WOOL; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; USTILAGO MAYDIS; WHEAT GLUTEN 60; 60; 10; 10; 10; 15; 10; 10; 60; 10; 10; 15; 60; 60; 60; 60; 10; 10; 10; 15; 60; 60; 60; 60; 60; 15; 15; 60; 60; 60; 10; 3; 10; 60; 60; 60; 60; 60; 60; 10; 15; 60; 60; 10; 3; 10; 10; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2312_eb378ec1-86b5-b39f-14c6-608d8dbbe2a5 55714-2312 HUMAN OTC DRUG Dairy - Grain - Nightshades Cow milk, Skim milk, Cow milk fat, Casein lactococcus lactis cultured aged, Casein lactococcus lactis cultured penicilium roqueforti cultured aged, Casein lctococcus lactis cultured penicillium camemberti cultured aged, Barley, Corn, Wheat gluten, Oat, White rice, Rye, Wheat, Lycopersicum esculentum, Sac. lac., Solanum tuberosum,Torula cerevisiae, Ustilago maidis, Antimon. crud., Arg.nit., Arsenicum alb., Baptisia, Bryonia, Carduus benedictus, Cinchona, Gelsemium, Ipecac., Lachesis, Lycopodium LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BARLEY; BRYONIA ALBA ROOT; CAPSICUM; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CENTAUREA BENEDICTA; CINCHONA OFFICINALIS BARK; CORN; COW MILK; COW MILK FAT; DATURA STRAMONIUM; ELYMUS REPENS ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; IPECAC; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LACTOSE; LYCOPODIUM CLAVATUM SPORE; OAT; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; RYE; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SKIM MILK; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP; SOLANUM LYCOPERSICUM; SOLANUM NIGRUM WHOLE; SOLANUM TUBEROSUM; SOLIDAGO VIRGAUREA FLOWERING TOP; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; USTILAGO MAYDIS; VERBASCUM THAPSUS; WHEAT; WHEAT GLUTEN; WHITE RICE 10; 10; 15; 10; 60; 10; 15; 60; 60; 60; 10; 10; 60; 60; 60; 15; 10; 10; 15; 10; 3; 10; 15; 10; 60; 10; 10; 10; 60; 15; 10; 10; 60; 10; 15; 15; 15; 15; 3; 15; 10; 15; 10; 60; 60; 60 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2313_7fe9b9c7-63f2-46be-8a2a-97780bec0ad6 55714-2313 HUMAN OTC DRUG Dairy - Grain - Nightshades Cow milk, Skim milk, Cow milk fat, Casein lactococcus lactis cultured aged, Casein lactococcus lactis cultured penicilium roqueforti cultured aged, Casein lctococcus lactis cultured penicillium camemberti cultured aged, Barley, Corn, Wheat gluten, Oat, White rice, Rye, Wheat, Lycopersicum esculentum, Sac. lac., Solanum tuberosum,Torula cerevisiae, Ustilago maidis, Antimon. crud., Arg.nit., Arsenicum alb., Baptisia, Bryonia, Carduus benedictus, Cinchona, Gelsemium, Ipecac., Lachesis, Lycopodium PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BARLEY; BRYONIA ALBA ROOT; CAPSICUM; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CENTAUREA BENEDICTA; CINCHONA OFFICINALIS BARK; CORN; COW MILK; COW MILK FAT; DATURA STRAMONIUM; ELYMUS REPENS ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; IPECAC; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LACTOSE; LYCOPODIUM CLAVATUM SPORE; OAT; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; RYE; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SKIM MILK; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP; SOLANUM LYCOPERSICUM; SOLANUM NIGRUM WHOLE; SOLANUM TUBEROSUM; SOLIDAGO VIRGAUREA FLOWERING TOP; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; USTILAGO MAYDIS; VERBASCUM THAPSUS; WHEAT; WHEAT GLUTEN; WHITE RICE 10; 10; 15; 10; 60; 10; 15; 60; 60; 60; 10; 10; 60; 60; 60; 15; 10; 10; 15; 10; 3; 10; 15; 10; 60; 10; 10; 10; 60; 15; 10; 10; 60; 10; 15; 15; 15; 15; 3; 15; 10; 15; 10; 60; 60; 60 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2315_52e7721b-976f-1cf3-b960-6e76224890c0 55714-2315 HUMAN OTC DRUG Food Allergy - Additive E102 Tartrazine, E104 Quinoline yellow, E110 Sunset/Orange yellow, E122 Carmoisine, E123 Armaranth, E124 Cochineal red A, E127 Erythrosine, D128 Red 2G, E 132 Indigotine, E141 Copper/Chlorophyll Complex, E142 Green S, E211 Sodium benzoate, E212 Potassium benzoate, E216 Propyl P-hydroxybenzoate, E223 Sodium metabisulphate, E231 Orthophenylphenol, E250 Sodium nitrate, E300 Ascorbic acid, E399 Sodium mono/bi/triphosphate, E951 Aspartame, Monosodium glutamate, Beef, Pork, Lamb, Chicken, Turkey, Clam PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. 2-PHENYLPHENOL; ABRUS PRECATORIUS SEED; ACID GREEN 50; ACID RED 1; ACONITUM NAPELLUS; ALLYLTHIOUREA; ALPINE STRAWBERRY; AMANITA MUSCARIA FRUITING BODY; AMARANTH; ANACARDIUM OCCIDENTALE FRUIT; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ASCORBIC ACID; ASPARTAME; BAPTISIA TINCTORIA ROOT; BEEF; BLACK MUSTARD SEED; BRAZIL NUT; CAFFEINE; CAPSICUM; CARMOISINE; CHICKEN; CINCHONA OFFICINALIS BARK; CINNAMON; COD, UNSPECIFIED; CRAB LEG, UNSPECIFIED; CYNARA SCOLYMUS LEAF; D&C YELLOW NO. 10; EGG; FD&C BLUE NO. 2; FD&C RED NO. 3; FD&C YELLOW NO. 5; FD&C YELLOW NO. 6; GARLIC; GELSEMIUM SEMPERVIRENS ROOT; GINGER; GLYCYRRHIZA GLABRA; HAZELNUT, UNSPECIFIED; HERRING, UNSPECIFIED; HISTAMINE DIHYDROCHLORIDE; IPECAC; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LACTOSE; LAMB; LEDUM PALUSTRE TWIG; LYCOPERDON UTRIFORME FRUITING BODY; LYCOPODIUM CLAVATUM SPORE; MENTHA PIPERITA; MONOSODIUM GLUTAMATE; NUTMEG; ONION; OYSTER, UNSPECIFIED; PEANUT; PHOSPHORUS; PODOPHYLLUM; PONCEAU 4R; PORK; POTASSIUM BENZOATE; PROPYLPARABEN; PULSATILLA VULGARIS; QUAHOG, UNSPECIFIED; SACCHARIN; SACCHAROMYCES CEREVISIAE; SALMON, UNSPECIFIED; SCALLOP, UNSPECIFIED; SEPIA OFFICINALIS JUICE; SHRIMP, UNSPECIFIED; SODIUM BENZOATE; SODIUM CHLORIDE; SODIUM COPPER CHLOROPHYLLIN; SODIUM DITHIONATE; SODIUM NITRITE; SODIUM TRIPOLYPHOSPHATE; SOLANUM LYCOPERSICUM; SOLANUM NIGRUM WHOLE; SOLANUM TUBEROSUM; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; TOXICODENDRON PUBESCENS LEAF; TROUT, UNSPECIFIED; TUNA, UNSPECIFIED; TURKEY; URTICA URENS; USTILAGO MAYDIS 60; 15; 60; 60; 10; 15; 15; 15; 60; 15; 10; 10; 60; 60; 10; 60; 15; 15; 15; 15; 60; 60; 10; 15; 15; 60; 15; 60; 60; 60; 60; 60; 60; 15; 10; 15; 15; 15; 15; 15; 10; 3; 10; 15; 60; 10; 15; 10; 15; 60; 15; 15; 60; 15; 10; 10; 60; 60; 60; 60; 10; 60; 15; 15; 15; 60; 10; 60; 60; 10; 60; 60; 60; 60; 15; 15; 15; 3; 10; 10; 15; 15; 60; 10; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2316_ca8327a8-7713-c0cb-5c20-d93bf687cc02 55714-2316 HUMAN OTC DRUG Hyperactivity - Mental Focus Adrenalinum, Tarentula cubensis, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Chamomilla, Cypripedium, Digitalis, Gelsemium, Humulus, Ignatia, Impatiens glandulifera flos, Iodium, Lachesis, Lycopodium, Nat. mur., Nux vom., Scutellaria lateriflora, Staphysag., Stramonium, Theridion, Echinacea, Gingko, Hypericum, Passiflora LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; CITHARACANTHUS SPINICRUS; CYPRIPEDIUM PARVIFOLUM ROOT; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; DIGITALIS; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; HOPS; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM 10; 10; 10; 15; 10; 10; 10; 10; 3; 15; 10; 3; 10; 3; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2317_0934786e-01ad-b24f-54c2-3b02c82fdf26 55714-2317 HUMAN OTC DRUG Hyperactivity - Mental Focus Adrenalinum, Tarentula cubensis, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Chamomilla, Cypripedium, Digitalis, Gelsemium, Humulus, Ignatia, Impatiens glandulifera flos, Iodium, Lachesis, Lycopodium, Nat. mur., Nux vom., Scutellaria lateriflora, Staphysag., Stramonium, Theridion, Echinacea, Gingko, Hypericum, Passiflora PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; CITHARACANTHUS SPINICRUS; CYPRIPEDIUM PARVIFOLUM ROOT; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; DIGITALIS; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; HOPS; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM 10; 10; 10; 15; 10; 10; 10; 10; 3; 15; 10; 3; 10; 3; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2320_27624e01-8c96-474d-8c94-41d2b67290b3 55714-2320 HUMAN OTC DRUG Heavy Metal Detox Allium sativum, Aluminium metallicum, Arg. met., Aur. met., Baryta carb., Beryllium metallicum, Bismuthum metallicum, Cadmium metallicum, Calc. fluor., Carbo veg., Chelidonium majus, Cinchona, Cobaltum met., Cuprum met., Glycyrrhiza glabra, Hydrofluoricum acidum, Iris versicolor, Manganum metallicum, Merc. viv., Niccolum metallicum, Osmium metallicum, Platinum met., Plumb. met., Stannum met., Strontium carb., Thallium metallicum, Titanium metallicum, Carduus mar., Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ALUMINUM; BARIUM CARBONATE; BERYLLIUM; BISMUTH; CADMIUM; CALCIUM FLUORIDE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; COBALT; COPPER; GARLIC; GLYCYRRHIZA GLABRA; GOLD; HYDROFLUORIC ACID; IRIS VERSICOLOR ROOT; LEAD; MANGANESE; MERCURY; NICKEL; OSMIUM; PLATINUM; SILVER; SILYBUM MARIANUM SEED; STRONTIUM CARBONATE; TARAXACUM OFFICINALE; THALLIUM; TIN; TITANIUM 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 3; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2321_ca7e9a2f-740c-481f-32ad-0a650880cdc2 55714-2321 HUMAN OTC DRUG Heavy Metal Detox Allium sativum, Aluminium metallicum, Arg. met., Aur. met., Baryta carb., Beryllium metallicum, Bismuthum metallicum, Cadmium metallicum, Calc. fluor., Carbo veg., Chelidonium majus, Cinchona, Cobaltum met., Cuprum met., Glycyrrhiza glabra, Hydrofluoricum acidum, Iris versicolor, Manganum metallicum, Merc. viv., Niccolum metallicum, Osmium metallicum, Platinum met., Plumb. met., Stannum met., Strontium carb., Thallium metallicum, Titanium metallicum, Carduus mar., Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ALUMINUM; BARIUM CARBONATE; BERYLLIUM; BISMUTH; CADMIUM; CALCIUM FLUORIDE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; COBALT; COPPER; GARLIC; GLYCYRRHIZA GLABRA; GOLD; HYDROFLUORIC ACID; IRIS VERSICOLOR ROOT; LEAD; MANGANESE; MERCURY; NICKEL; OSMIUM; PLATINUM; SILVER; SILYBUM MARIANUM SEED; STRONTIUM CARBONATE; TARAXACUM OFFICINALE; THALLIUM; TIN; TITANIUM 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 3; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2322_4e12d2ba-c37e-88c7-4b6f-ab61cc71e7b2 55714-2322 HUMAN OTC DRUG Morning Sickness Bismuthum metallicum, Bryonia, Cimicifuga, Gossypium herbaceum, Ipecac., Kreosotum, Lycopodium, Mag. carb., Nux vom., Pulsatilla, Sepia, Symphoricarpus racemosus, Tabacum, Zingiber, Chamomilla, Hydrastis, Iris versicolor LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BISMUTH; BLACK COHOSH; BRYONIA ALBA ROOT; GINGER; GOLDENSEAL; GOSSYPIUM HERBACEUM ROOT BARK; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SYMPHORICARPOS ALBUS FRUIT; TOBACCO LEAF; WOOD CREOSOTE 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2323_4afffeaf-4d01-655c-eb48-ff575d346e19 55714-2323 HUMAN OTC DRUG Morning Sickness Bismuthum metallicum, Bryonia, Cimicifuga, Gossypium herbaceum, Ipecac., Kreosotum, Lycopodium, Mag. carb., Nux vom., Pulsatilla, Sepia, Symphoricarpus racemosus, Tabacum, Zingiber, Chamomilla, Hydrastis, Iris versicolor PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BISMUTH; BLACK COHOSH; BRYONIA ALBA ROOT; GINGER; GOLDENSEAL; GOSSYPIUM HERBACEUM ROOT BARK; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SYMPHORICARPOS ALBUS FRUIT; TOBACCO LEAF; WOOD CREOSOTE 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2324_a628616c-629a-e984-9d9d-eb96fedad3e2 55714-2324 HUMAN OTC DRUG Rosacea Arsenicum alb., Arsenicum bromatum, Carbo animalis, Causticum, Hydrocotyle, Kali brom., Kali iod., Kreosotum, Lycopodium, Nux vom., Petroleum, Rhus toxicodendron, Sepia, Sulphur, Echinacea, Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIBROMIDE; ARSENIC TRIOXIDE; CARBO ANIMALIS; CAUSTICUM; CENTELLA ASIATICA; ECHINACEA, UNSPECIFIED; KEROSENE; LYCOPODIUM CLAVATUM SPORE; POTASSIUM BROMIDE; POTASSIUM IODIDE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; WOOD CREOSOTE 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2325_bd05daf9-d80e-8db1-55d1-1489b0ed25f3 55714-2325 HUMAN OTC DRUG Rosacea Arsenicum alb., Arsenicum bromatum, Carbo animalis, Causticum, Hydrocotyle, Kali brom., Kali iod., Kreosotum, Lycopodium, Nux vom., Petroleum, Rhus toxicodendron, Sepia, Sulphur, Echinacea, Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIBROMIDE; ARSENIC TRIOXIDE; CARBO ANIMALIS; CAUSTICUM; CENTELLA ASIATICA; ECHINACEA, UNSPECIFIED; KEROSENE; LYCOPODIUM CLAVATUM SPORE; POTASSIUM BROMIDE; POTASSIUM IODIDE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; WOOD CREOSOTE 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2326_61dc5e58-8cef-a495-653f-17cdc860e509 55714-2326 HUMAN OTC DRUG Breast Help Bufo rana, Apis mel., Asterias rubens, Belladonna, Bryonia, Calc. carb., Chamomilla, Chimaphila umbellata, Cinchona, Conium, Croton, Echinacea, Graphites, Helonias dioica, Lachesis, Merc. viv., Phellandrium aquaticum Phosphorus, Phytolacca, Pulsatilla, Sanguinaria, Silicea, Hamamelis, Ruta, Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ASTERIAS RUBENS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; BUFO BUFO CUTANEOUS GLAND; CHAMAELIRIUM LUTEUM ROOT; CHIMAPHILA UMBELLATA; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; ECHINACEA, UNSPECIFIED; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MERCURY; OENANTHE AQUATICA FRUIT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; TARAXACUM OFFICINALE 10; 10; 10; 10; 15; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2327_614cb514-2944-8d3d-e2c8-a83ff38c81a2 55714-2327 HUMAN OTC DRUG Breast Help Bufo rana, Apis mel., Asterias rubens, Belladonna, Bryonia, Calc. carb., Chamomilla, Chimaphila umbellata, Cinchona, Conium, Croton, Echinacea, Graphites, Helonias dioica, Lachesis, Merc. viv., Phellandrium aquaticum Phosphorus, Phytolacca, Pulsatilla, Sanguinaria, Silicea, Hamamelis, Ruta, Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ASTERIAS RUBENS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; BUFO BUFO CUTANEOUS GLAND; CHAMAELIRIUM LUTEUM ROOT; CHIMAPHILA UMBELLATA; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; ECHINACEA, UNSPECIFIED; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MERCURY; OENANTHE AQUATICA FRUIT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; TARAXACUM OFFICINALE 10; 10; 10; 10; 15; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2328_2bb7d78c-71f9-ffd6-73f7-1c3b03075f32 55714-2328 HUMAN OTC DRUG Edema - Fluid Retention Elaps corallinus, Apis mel., Arsenicum alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus horridus, Digitalis, Juniperus com., Lachesis, Merc. viv., Naja, Nat. carb., Nat.sulphuricum, Rhus toxicodendron, Sambucus nig., Strophanthus hispidus, Thuja occ., Vipera berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica ur. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; ECHINACEA, UNSPECIFIED; JUNIPERUS COMMUNIS FRUIT; LACHESIS MUTA VENOM; LYTTA VESICATORIA; MERCURY; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; SAMBUCUS NIGRA FLOWERING TOP; SODIUM CARBONATE; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; URTICA URENS; VIPERA BERUS VENOM 10; 3; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 30; 10; 10; 10; 10; 3; 10; 3; 10; 10; 3; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2329_a9be2658-d722-12b7-0183-5379182f9c46 55714-2329 HUMAN OTC DRUG Edema - Fluid Retention Elaps corallinus, Apis mel., Arsenicum alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus horridus, Digitalis, Juniperus com., Lachesis, Merc. viv., Naja, Nat. carb., Nat.sulphuricum, Rhus toxicodendron, Sambucus nig., Strophanthus hispidus, Thuja occ., Vipera berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica ur. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; ECHINACEA, UNSPECIFIED; JUNIPERUS COMMUNIS FRUIT; LACHESIS MUTA VENOM; LYTTA VESICATORIA; MERCURY; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; SAMBUCUS NIGRA FLOWERING TOP; SODIUM CARBONATE; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; URTICA URENS; VIPERA BERUS VENOM 10; 3; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 30; 10; 10; 10; 10; 3; 10; 3; 10; 10; 3; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2330_5f59cca7-93c9-a91c-3ae4-01604e04dcdf 55714-2330 HUMAN OTC DRUG Stress Tension Aconitum nap. ., Arg. nit. ., Aur.met., Baptisia, Bryonia, Chelidonium majus,Cimicifuga, Conium, Gelsemium, Ignatia, Kali carb., Lachesis, Lilium, Lycopodium, Nat. carb., Nat.mur., Phosphoricum ac., Phosphorus, Picricum ac.,Plumb. met., Sepia, Staphysag., Stramonium, Thujaocc., Zinc. met., Chamomilla, Hypericum, Valeriana, LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; BAPTISIA TINCTORIA; BLACK COHOSH; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; GOLD; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LEAD; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THUJA OCCIDENTALIS LEAFY TWIG; TRINITROPHENOL; VALERIAN; ZINC 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2331_65002e3c-9fec-6ac0-441a-bcbed02ecea9 55714-2331 HUMAN OTC DRUG Stress - Tension Aconitum nap., Arg. nit., Aur.met., Baptisia, Bryonia, Chelidonium majus, Cimicifuga, Conium, Gelsemium, Ignatia, Kali carb., Lachesis, Lilium, Lycopodium, Nat. carb., Nat.mur., Phosphoricum ac., Phosphorus, Picricum ac., Plumb. met., Sepia, Staphysag., Stramonium, Thuja occ., Zinc. met., Chamomilla, Hypericum, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; BAPTISIA TINCTORIA; BLACK COHOSH; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; GOLD; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LEAD; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THUJA OCCIDENTALIS LEAFY TWIG; TRINITROPHENOL; VALERIAN; ZINC 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2332_aed0c4e6-9d96-52c6-168e-7eca783813ed 55714-2332 HUMAN OTC DRUG Ear Wax Build-Up Elaps corallinus, Alumina, Carbo veg., Causticum, Conium, Graphites, Kali bic.,Kali mur., Lachesis, Lycopodium, Petroleum, Pulsatilla, Sabadilla, Sepia, Silicea, Spongia, Verbascum, Viola odorata LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ALUMINUM OXIDE; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; LACHESIS MUTA VENOM; LIQUID PETROLEUM; LYCOPODIUM CLAVATUM SPORE; MICRURUS CORALLINUS VENOM; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; VERBASCUM THAPSUS; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 30; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2333_28dacbd0-cacf-6b3f-3dad-744ff4ed90aa 55714-2333 HUMAN OTC DRUG Ear Wax Build-Up Elaps corallinus, Alumina, Carbo veg., Causticum, Conium, Graphites, Kali bic., Kali mur., Lachesis, Lycopodium, Petroleum, Pulsatilla, Sabadilla, Sepia, Silicea, Spongia, Verbascum, Viola odorata PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ALUMINUM OXIDE; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; LACHESIS MUTA VENOM; LIQUID PETROLEUM; LYCOPODIUM CLAVATUM SPORE; MICRURUS CORALLINUS VENOM; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; VERBASCUM THAPSUS; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 30; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2334_5165510d-5a80-aeef-fc88-5f0a7ea586a0 55714-2334 HUMAN OTC DRUG Shingles Apis mel., Arsenicum alb., Asterias rubens, Cantharis, Cistus canadensis, Croton, Dolichos, Dulcamara, Graphites, Grindelia, Hypericum, Iris versicolor, Lycopodium, Mezereum, Ranunc. bulb., Rhus toxicodendron, Staphysag., Sulphur, Thuja occ., Zinc. met., Chamomilla, Echinacea. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ASTERIAS RUBENS; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GRAPHITE; GRINDELIA HIRSUTULA FLOWERING TOP; HELIANTHEMUM CANADENSE; HYPERICUM PERFORATUM; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MATRICARIA RECUTITA; MUCUNA PRURIENS FRUIT TRICHOME; RANUNCULUS BULBOSUS; SOLANUM DULCAMARA TOP; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; ZINC 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2335_6d6238e2-bf6b-a03e-4141-753b35d6e8c6 55714-2335 HUMAN OTC DRUG Shingles Apis mel., Arsenicum alb., Asterias rubens, Cantharis, Cistus canadensis, Croton, Dolichos, Dulcamara, Graphites, Grindelia, Hypericum, Iris versicolor, Lycopodium, Mezereum, Ranunc. bulb., Rhus toxicodendron, Staphysag., Sulphur, Thuja occ., Zinc. met., Chamomilla, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ASTERIAS RUBENS; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GRAPHITE; GRINDELIA HIRSUTULA FLOWERING TOP; HELIANTHEMUM CANADENSE; HYPERICUM PERFORATUM; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MATRICARIA RECUTITA; MUCUNA PRURIENS FRUIT TRICHOME; RANUNCULUS BULBOSUS; SOLANUM DULCAMARA TOP; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; ZINC 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2336_b94e0f36-8ad2-e8f0-bb2c-4d94fd14c7fa 55714-2336 HUMAN OTC DRUG Thyroid Assist Adrenalinum, Thyroidinum, Aloe, Calc. carb., Chelidonium majus, Conium, Graphites, Iodium, Lachesis, Lycopodium, Lycopus virginicus, Phytolacca, Rhus toxicodendron, Silicea, Spongia, Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GRAPHITE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 3; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2337_dbcd3f8b-d56a-892b-4f0b-c6edefa51358 55714-2337 HUMAN OTC DRUG Thyroid Assist Adrenalinum, Thyroidinum, Aloe, Calc. carb., Chelidonium majus, Conium, Graphites, Iodium, Lachesis, Lycopodium, Lycopus virginicus, Phytolacca, Rhus toxicodendron, Silicea, Spongia, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GRAPHITE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 3; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2342_674d2f3e-0a8d-9991-cf13-03937246c079 55714-2342 HUMAN OTC DRUG Ear Ringing Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac., Tabacum, Thiosinaminum, Viola odorata, Hydrastis. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALLYLTHIOUREA; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; DYSPHANIA AMBROSIOIDES; GOLDENSEAL; GOLDENSEAL; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; QUININE SULFATE; SALICYLIC ACID; TOBACCO LEAF; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2343_6b005914-c0df-84b6-2125-6b2740fcec23 55714-2343 HUMAN OTC DRUG Ear Ringing Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac., Tabacum, Thiosinaminum, Viola odorata PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALLYLTHIOUREA; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; DYSPHANIA AMBROSIOIDES; GOLDENSEAL; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; QUININE SULFATE; SALICYLIC ACID; TOBACCO LEAF; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2346_5e9207c0-a460-e7f8-9b8c-72b68e6fb9fa 55714-2346 HUMAN OTC DRUG Lymph Assist Asterias rubens, Aur. met., Belladonna, Benzoicum acidum, Berber. vulg., Bryonia, Calc. carb., Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Dioscorea, Iris versicolor, Nat. carb., Nux vom., Ptelea, Carduus mar., Echinacea, Solidago, Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ASTERIAS RUBENS; ATROPA BELLADONNA; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; ECHINACEA, UNSPECIFIED; GOLD; IRIS VERSICOLOR ROOT; LYTTA VESICATORIA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; SODIUM CARBONATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 3; 10; 3; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2347_b9d81116-551c-73d8-c58a-53b8d7e3b9a0 55714-2347 HUMAN OTC DRUG Lymph Assist Asterias rubens, Aur. met., Belladonna, Benzoicum acidum, Berber. vulg., Bryonia, Calc. carb., Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Dioscorea, Iris versicolor, Nat. carb., Nux vom., Ptelea, Carduus mar., Echinacea, Solidago, Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ASTERIAS RUBENS; ATROPA BELLADONNA; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; ECHINACEA, UNSPECIFIED; GOLD; IRIS VERSICOLOR ROOT; LYTTA VESICATORIA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; SODIUM CARBONATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 3; 10; 3; 10; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2348_8adac974-ff77-7d4f-a4cf-5e8882d6415f 55714-2348 HUMAN OTC DRUG Restless Leg Mygale, Agaricus musc., Causticum, Cinchona, Conium, Cuprum met., Gelsemium, Hyoscyamus, Hypericum, Kali carb., Mag. carb., Merc. viv., Nux vom., Plumb. met., Rhus toxicodendron, Secale, Strychninum, Tarentula hispana, Valeriana, Verbascum, Zinc. met., Chamomilla,Passiflora LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AVICULARIA AVICULARIA; CAUSTICUM; CINCHONA OFFICINALIS BARK; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; COPPER; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; LEAD; LYCOSA TARANTULA; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; MERCURY; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; STRYCHNINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VALERIAN; VERBASCUM THAPSUS; ZINC 10; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 3; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2349_e7ab1a31-ff88-f34b-5ea3-c8bd7371f064 55714-2349 HUMAN OTC DRUG Restless Leg Mygale, Agaricus musc., Causticum, Cinchona, Conium, Cuprum met., Gelsemium, Hyoscyamus, Hypericum, Kali carb., Mag. carb., Merc. viv., Nux vom., Plumb. met., Rhus toxicodendron, Secale, Strychninum, Tarentula hispana, Valeriana, Verbascum, Zinc. met., Chamomilla,Passiflora PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AVICULARIA AVICULARIA; CAUSTICUM; CINCHONA OFFICINALIS BARK; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; COPPER; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; LEAD; LYCOSA TARANTULA; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; MERCURY; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; STRYCHNINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VALERIAN; VERBASCUM THAPSUS; ZINC 10; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 3; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2350_39a94f92-80ab-2615-2dd5-a93cad659620 55714-2350 HUMAN OTC DRUG Vitiligo Arsenicum alb., Berber. vulg., Bovista, Dolichos, Echinacea, Hura brasiliensis, Hydrocotyle, Lycopodium, Mezereum, Rhus toxicodendron, Rumex crisp., Sepia, Taraxacum,Thuja occ., Urtica ur., Iris versicolor LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; CENTELLA ASIATICA; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GIANT PUFFBALL; HURA CREPITANS SAP; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MUCUNA PRURIENS FRUIT TRICHOME; RUMEX CRISPUS ROOT; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2351_ede8eff5-df1c-cb37-bc53-711662e5025d 55714-2351 HUMAN OTC DRUG Vitiligo Arsenicum alb., Berber. vulg., Bovista, Dolichos, Echinacea, Hura brasiliensis, Hydrocotyle, Lycopodium, Mezereum, Rhus toxicodendron, Rumex crisp., Sepia, Taraxacum,Thuja occ., Urtica ur., Iris versicolor PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; CENTELLA ASIATICA; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GIANT PUFFBALL; HURA CREPITANS SAP; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MUCUNA PRURIENS FRUIT TRICHOME; RUMEX CRISPUS ROOT; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2354_d57f0aa0-9085-b724-08f0-6cd1f7338332 55714-2354 HUMAN OTC DRUG Cell Salts Calc. fluor., Calc. phos., Calc.sulph., Ferrum phosphoricum, Kali mur., Kali phos., Kali sulph., Mag. phos., Nat. mur., Nat. phos., Nat.sulphuricum, Silicea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2355_504e5a6b-69c6-daaa-873a-aee37d5bba5c 55714-2355 HUMAN OTC DRUG Cell Salts Calc. fluor., Calc. phos., Calc.sulph., Ferrum phosphoricum, Kali mur., Kali phos., Kali sulph., Mag. phos., Nat. mur., Nat. phos., Nat.sulphuricum, Silicea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHATE ION; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2364_9755751e-a450-fc35-7ea0-e35d07fc33e4 55714-2364 HUMAN OTC DRUG Vitality Adrenalinum, Aloe, Arsenicum alb., Baptisia, Berber. Aqui., Berber. vulg., Bryonia, Chelidonium majus, Crotalus horridus, Digitalis, Ferrum metallicum, Glonoinum, Glycyrrhiza glabra , Hydrocotyle, Iodium, Iris versicolor, Lachesis, Lycopodium, Nat. mur., Nux vom., Rhus toxicodendron, Ruta, Thuja occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CENTELLA ASIATICA; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GLYCYRRHIZA GLABRA; IODINE; IRIS VERSICOLOR ROOT; IRON; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAHONIA AQUIFOLIUM ROOT BARK; NITROGLYCERIN; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 3; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2365_6a064c42-aae1-c575-2463-6e276bb3c73a 55714-2365 HUMAN OTC DRUG Vitality Adrenalinum, Aloe, Arsenicum alb., Baptisia, Berber. Aqui., Berber. vulg., Bryonia, Chelidonium majus, Crotalus horridus, Digitalis, Ferrum metallicum, Glonoinum, Glycyrrhiza glabra , Hydrocotyle, Iodium, Iris versicolor, Lachesis, Lycopodium, Nat. mur., Nux vom., Rhus toxicodendron, Ruta, Thuja occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CENTELLA ASIATICA; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GLYCYRRHIZA GLABRA; IODINE; IRIS VERSICOLOR ROOT; IRON; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAHONIA AQUIFOLIUM ROOT BARK; NITROGLYCERIN; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 3; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2366_4120deb4-3543-419f-7394-1eb8208297ad 55714-2366 HUMAN OTC DRUG Natural Response Aconitum nap., Arnica, Arsenicum alb., Bryonia, Echinacea, Ledum, Cenchris, Crotalus casc. Crotalus hor., Lachesis, Merc. corros., Naja, Phos., Toxicophis, Vipera, Elaps cor., Heloderma LIQUID ORAL 20141110 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AGKISTRODON CONTORTRIX VENOM; AGKISTRODON PISCIVORUS VENOM; ARNICA MONTANA; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CROTALUS DURISSUS TERRIFICUS VENOM; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; HELODERMA SUSPECTUM VENOM; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; MERCURIC CHLORIDE; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; PHOSPHORUS; VIPERA BERUS VENOM 10; 15; 15; 10; 10; 10; 15; 15; 10; 30; 15; 10; 15; 30; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2367_bcb97377-de7d-6300-5e43-da545227e306 55714-2367 HUMAN OTC DRUG Natural Response Aconitum nap., Arnica, Arsenicum alb., Bryonia, Echinacea, Ledum, Cenchris, Crotalus casc. Crotalus hor., Lachesis, Merc. corros., Naja, Phos., Toxicophis, Vipera, Elaps cor., Heloderma PELLET ORAL 20141110 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AGKISTRODON CONTORTRIX VENOM; AGKISTRODON PISCIVORUS VENOM; ARNICA MONTANA; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CROTALUS DURISSUS TERRIFICUS VENOM; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; HELODERMA SUSPECTUM VENOM; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; MERCURIC CHLORIDE; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; PHOSPHORUS; VIPERA BERUS VENOM 10; 15; 15; 10; 10; 10; 15; 15; 10; 30; 15; 10; 15; 30; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-2368_41578178-474b-4906-f325-2ae16b3b5326 55714-2368 HUMAN OTC DRUG Complementary Complex Influenzinum, Anthracinum, Arnica, Belladonna, Aconitum nap., Arsenicum alb., Baptisia, Bryonia, Hepar sulph. calc., Iodium, Lachesis, Lycopodium, Merc. viv., Nux vom., Phos., Pulsatilla, Rhus tox., Apis mel., Echinacea, Hydrastis, Thuja occ., Aaricus musc,. Allium sat., Aloe, Calc. carb., Calendula, Capiscum, Carduus mar., Salvia, Selenium, Taraxacum, Tarentula hisp., Zinc. met., Zingiber LIQUID ORAL 20141110 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALOE; AMANITA MUSCARIA FRUITING BODY; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; AZADIRACHTA INDICA BARK; BACILLUS ANTHRACIS; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; ECHINACEA, UNSPECIFIED; GARLIC; GINGER; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; MERCURY; MILK THISTLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SAGE; SELENIUM; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 3; 10; 10; 10; 10; 15; 10; 10; 10; 10; 10; 3; 10; 10; 3; 30; 30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-2369_89894d18-29d2-b15d-ef1c-e7bde9809f65 55714-2369 HUMAN OTC DRUG Complementary Complex Influenzinum, Anthracinum, Arnica, Belladonna, Aconitum nap., Arsenicum alb., Baptisia, Bryonia, Hepar sulph. calc., Iodium, Lachesis, Lycopodium, Merc. viv., Nux vom., Phos., Pulsatilla, Rhus tox., Apis mel., Echinacea, Hydrastis, Thuja occ., Aaricus musc,. Allium sat., Aloe, Calc. carb., Calendula, Capiscum, Carduus mar., Salvia, Selenium, Taraxacum, Tarentula hisp., Zinc. met., Zingiber PELLET ORAL 20141110 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALOE; AMANITA MUSCARIA FRUITING BODY; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; AZADIRACHTA INDICA BARK; BACILLUS ANTHRACIS; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; ECHINACEA, UNSPECIFIED; GARLIC; GINGER; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; MERCURY; MILK THISTLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SAGE; SELENIUM; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 3; 10; 10; 10; 10; 15; 10; 10; 10; 10; 10; 3; 10; 10; 3; 30; 30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-4400_e821e739-51c3-3c48-421b-2c8230efefd6 55714-4400 HUMAN PRESCRIPTION DRUG Drainer BENZOIC ACIDUM, BERBERIS VULG., BRYONIA, CANTHARIS,CARDUUS BENEDICTUS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DIOSCOREA, DOLICHOS, IRIS VERSICOLOR, JUNIPERUS COM., NUX VOM., PTELEA, TARAXACUM, URICUM ACIDUM, CARDUUS MAR., CYNARA SCOLYMUS, SOLIDAGO, TARAXACUM LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CNICUS BENEDICTUS; CYNARA SCOLYMUS LEAF; DIOSCOREA VILLOSA TUBER; IRIS VERSICOLOR ROOT; JUNIPER; LYTTA VESICATORIA; MUCUNA PRURIENS FRUIT TRICHOME; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TARAXACUM OFFICINALE; URIC ACID 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 3; 3; 15; 15; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] 55714-4401_f4361cbe-7f48-4dd2-ff0c-b2dc9d310f64 55714-4401 HUMAN PRESCRIPTION DRUG Drainer BENZOICUM ACIDUM, BERBERIS VULG., BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DIOSCOREA, DOLICHOS, IRIS VERSICOLOR, JUNIPERUS COM., NUX VOM., PTELEA, TARAXACUM, URICUM ACIDUM, CARDUUS MAR., CYNARA SCOLYMUS, SOLIDAGO PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; DIOSCOREA VILLOSA TUBER; IRIS VERSICOLOR ROOT; JUNIPER BERRY; LYTTA VESICATORIA; MUCUNA PRURIENS FRUIT TRICHOME; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; URIC ACID 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 3; 3; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4402_3cbecb6e-2002-8de8-bee3-c612623eb03c 55714-4402 HUMAN PRESCRIPTION DRUG Eczema Skin Care Antimon. crud., Arsenicum alb., Berber. vulg., Bovista , Bryonia , Cantharis , Chelidonium majus, Croton, Dulcamara, Graphites, Hepar sulph. calc., Lycopodium Mezereum, Nux vom, Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sepia, Sulphur iod, Echinacea, Rumex crisp., Taraxacum , Urtica ur., Echinacea, Rumex crisp., Taraxacum, Urtica ur. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA ANGUSTIFOLIA; ECHINACEA ANGUSTIFOLIA; GIANT PUFFBALL; GRAPHITE; KEROSENE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PULEX IRRITANS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; RUMEX CRISPUS ROOT; SEPIA OFFICINALIS JUICE; SMILAX REGELII ROOT; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR IODIDE; TARAXACUM OFFICINALE; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; URTICA URENS; URTICA URENS 20; 20; 20; 20; 20; 20; 20; 20; 3; 8; 20; 20; 20; 20; 20; 20; 20; 3; 8; 20; 20; 20; 20; 20; 3; 8; 20; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4403_f7b98d1a-b8fd-de73-5383-a38ad69e15bc 55714-4403 HUMAN PRESCRIPTION DRUG Eczema Skin Care Antimon. crud., Arsenicum alb., Berber. vulg., Bovista , Bryonia , Cantharis , Chelidonium majus, Croton, Dulcamara, Graphites, Hepar sulph. calc., Lycopodium Mezereum, Nux vom, Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sepia, Sulphur iod, Echinacea, Rumex crisp., Taraxacum , Urtica ur. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GIANT PUFFBALL; GRAPHITE; KEROSENE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PULEX IRRITANS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SEPIA OFFICINALIS JUICE; SMILAX REGELII ROOT; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR IODIDE; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 8; 20; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4404_063cfb19-5187-5b49-86e6-a441848f6c97 55714-4404 HUMAN PRESCRIPTION DRUG Insomnia Absinthium, Anacardium occidentale, Arg. nit., Arsenicum alb., Belladonna, Bryonia,Calc. carb., Camphora, Chamomilla, Cimicifuga,Cinchona, Coffea cruda, Cypripedium, Gelsemium,Humulus, Hyoscyamus, Ignatia, Kali brom., Nuxvom., Passiflora, Pulsatilla, Scutellaria lateriflora,Sepia, Thuja occ., Passiflora, aleriana, Passiflora,Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANACARDIUM OCCIDENTALE FRUIT; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HOPS; HYOSCYAMUS NIGER; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM BROMIDE; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; SILVER NITRATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VALERIAN; VALERIAN; WORMWOOD 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 8; 15; 15; 15; 15; 15; 15; 15; 15; 3; 8; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4405_0157ca9d-4027-bf16-8e47-f4e52e76548b 55714-4405 HUMAN PRESCRIPTION DRUG Insomnia Absinthium, Anacardium occidentale, Arg. nit., Arsenicum alb., Belladonna, Bryonia, Calc. carb., Camphora, Chamomilla, Cimicifuga, Cinchona, Coffea cruda, Cypripedium, Gelsemium, Humulus, Hyoscyamus, Ignatia, Kali brom., Nux vom., Passiflora, Pulsatilla, Scutellaria lateriflora, Sepia, Thuja occ., Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HOPS; HYOSCYAMUS NIGER; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM BROMIDE; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VALERIAN; WORMWOOD 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4406_dd2e364d-9f27-9e02-970e-1d3986f51593 55714-4406 HUMAN PRESCRIPTION DRUG Bronchitis-Asthma Influenza A Virus, Influenza B Virus, Antimon. tart., Arsenicum alb., Bryonia, Camphora, Chelidonium majus, Cinchona, Drosera, Eucalyptus, Hepar sulph. calc., Histaminum hydrochloricum, Ipecac., Kali bic., Kali carb., Kali iod., Lycopodium, Myrrha, Natrum sulphuricum, Nux vom., Phosphorus, Pulsatilla, Sanguinaria, Spongia , Stannum met., Tussilago farfara, Verbascum, Echinacea, Lappa, Rumex crisp. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY POTASSIUM TARTRATE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAMPHOR (NATURAL); CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA; ECHINACEA, UNSPECIFIED; EUCALYPTUS GLOBULUS LEAF; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IPECAC; LYCOPODIUM CLAVATUM SPORE; MYRRH; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SANGUINARIA CANADENSIS ROOT; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS NUX-VOMICA SEED; TIN; TUSSILAGO FARFARA; VERBASCUM THAPSUS 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4407_4e0446dd-eef0-bab4-8096-85d3b79f4263 55714-4407 HUMAN PRESCRIPTION DRUG Bronchitis - Asthma Influenza A Virus, Influenza B Virus, Antimon. tart., Arsenicum alb., Bryonia, Camphora, Chelidonium majus, Cinchona, Drosera, Eucalyptus, Hepar sulph. calc., Histaminum hydrochloricum, Ipecac., Kali bic., Kali carb., Kali iod., Lycopodium, Myrrha, Natrum sulphuricum, Nux vom., Phosphorus, Pulsatilla, Sanguinaria, Spongia , Stannum met., Tussilago farfara, Verbascum, Echinacea, Lappa, Rumex crisp. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY POTASSIUM TARTRATE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAMPHOR (NATURAL); CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA; ECHINACEA, UNSPECIFIED; EUCALYPTUS GLOBULUS LEAF; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IPECAC; LYCOPODIUM CLAVATUM SPORE; MYRRH; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SANGUINARIA CANADENSIS ROOT; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS NUX-VOMICA SEED; TIN; TUSSILAGO FARFARA; VERBASCUM THAPSUS 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4408_70cfb514-bffb-d423-f8c3-88aaadc2d038 55714-4408 HUMAN PRESCRIPTION DRUG Fear Phobia Aconitum nap., Anacardium orientale, Arg. nit., Arsenicum alb., Cypripedium,Gelsemium, Ignatia, Kali carb., Lycopodium, Nat. mur., Phosphorus, Sambucus nig., Sepia, Staphysag., Stramonium, Tarentula hispana,Theridion, Passiflora, Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; CYPRIPEDIUM PARVIFOLUM ROOT; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; POTASSIUM CARBONATE; SAMBUCUS NIGRA FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THERIDION CURASSAVICUM; VALERIAN 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-4409_4a41b715-1278-161d-f6f5-c5e6af9ea25f 55714-4409 HUMAN PRESCRIPTION DRUG Fear Phobia Aconitum nap., Anacardium orientale, Arg. nit., Arsenicum alb., Cypripedium,Gelsemium, Ignatia, Kali carb., Lycopodium, Nat. mur., Phosphorus, Sambucus nig., Sepia, Staphysag., Stramonium, Tarentula hispana,Theridion, Passiflora, Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; CYPRIPEDIUM PARVIFOLUM ROOT; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; POTASSIUM CARBONATE; SAMBUCUS NIGRA FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THERIDION CURASSAVICUM; VALERIAN 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-4410_06faf3ae-4a98-de13-5769-84f8ae25d1c7 55714-4410 HUMAN PRESCRIPTION DRUG Influenza Influenzinum (combo), Histaminum hydrochloricum, Aconitum nap., Aralia quinquefolia, Arsenicum alb., Baptisia, Bryonia, Cinchona, Eupatorium perf., Gelsemium, Ipecac., Kali carb., Nux vom., Phosphorus, Rhus toxicodendron, Echinacea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IPECAC; PHOSPHORUS; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 8; 15; 15; 20; 35; 35; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4411_66fbda09-3253-1869-cc90-a412535c419c 55714-4411 HUMAN PRESCRIPTION DRUG Influenza Influenzinum (combo), Histaminum hydrochloricum, Aconitum nap., Aralia quinquefolia, Arsenicum alb., Baptisia, Bryonia, Cinchona, Eupatorium perf., Gelsemium, Ipecac., Kali carb., Nux vom., Phosphorus, Rhus toxicodendron, Echinacea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IPECAC; PHOSPHORUS; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 8; 15; 15; 20; 35; 35; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4416_a54763fa-079d-2c5e-9b0b-ebc30284d3c8 55714-4416 HUMAN PRESCRIPTION DRUG Ear Care Influenzinum, Tellurium metallicum, Apis mel, Arsenicum alb., Belladonna, Bryonia, Capsicum, Causticum, Cinchona, Conium, Dulcamara, Ferrum phosphoricum, Hepar sulph. calc., Kali sulph., Lycopodium, Merc. viv., Mezereum, Phosphorus, Plantago, Pulsatilla, Silicea, Verbascum, Echinacea, Hydrastis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORUS; PLANTAGO MAJOR; POTASSIUM SULFATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SOLANUM DULCAMARA STEM; TELLURIUM; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 3; 30; 30; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 55714-4417_5f438ba2-99ca-d4e1-344c-b09c11e9cd67 55714-4417 HUMAN PRESCRIPTION DRUG Ear Care Influenzinum, Tellurium metallicum, Apis mel, Arsenicum alb., Belladonna, Bryonia, Capsicum, Causticum, Cinchona, Conium, Dulcamara, Ferrum phosphoricum, Hepar sulph. calc., Kali sulph., Lycopodium, Merc. viv., Mezereum, Phosphorus, Plantago, Pulsatilla, Silicea, Verbascum, Echinacea, Hydrastis PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORUS; PLANTAGO MAJOR; POTASSIUM SULFATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SOLANUM DULCAMARA STEM; TELLURIUM; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 3; 30; 30; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 55714-4418_75a1924e-9293-110e-905c-4ecef365bb9e 55714-4418 HUMAN PRESCRIPTION DRUG Sinusitis Arsenicum iodatum, Bryonia, Cistus canadensis, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Iodium, Kali bic., Kali iod., Merc. iod. rub., Merc. viv., Nux vom., Phosphorus, Pulsatilla, Sabadilla, Sticta, Verbascum, Echinacea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; GOLDENSEAL; GOLDENSEAL; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; IODINE; LOBARIA PULMONARIA; MERCURIC IODIDE; MERCURY; PHOSPHORUS; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; STRYCHNOS NUX-VOMICA SEED; VERBASCUM THAPSUS 15; 15; 15; 3; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4419_81dde272-406f-e6a1-a936-d3804b4b7de5 55714-4419 HUMAN PRESCRIPTION DRUG Sinusitis Arsenicum iodatum, Bryonia, Cistus canadensis, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Iodium, Kali bic., Kali iod., Merc. iod. rub., Merc. viv., Nux vom., Phosphorus, Pulsatilla, Sabadilla, Sticta, Verbascum, Echinacea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; GOLDENSEAL; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; IODINE; LOBARIA PULMONARIA; MERCURIC IODIDE; MERCURY; PHOSPHORUS; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; STRYCHNOS NUX-VOMICA SEED; VERBASCUM THAPSUS 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4420_3bee5240-8977-e937-690d-a5556d7d7292 55714-4420 HUMAN PRESCRIPTION DRUG Cold Cough Influenzinum, Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procumbens, Gelsemium, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Kali bic., Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabadilla, Salvia, Sticta, Verbascum, Echinacea, Hydrastis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LOBARIA PULMONARIA; MERCURY; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SAGE; SCHOENOCAULON OFFICINALE SEED; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 20; 20; 20; 20; 8; 20; 20; 20; 20; 8; 20; 35; 35; 20; 20; 20; 20; 20; 20; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 55714-4421_b6445d2c-28e3-5e2b-8a4c-91fbf8465ae1 55714-4421 HUMAN PRESCRIPTION DRUG Cold - Cough Influenzinum, Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procumbens, Gelsemium, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Kali bic., Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabadilla, Salvia, Sticta, Verbascum, Echinacea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LOBARIA PULMONARIA; MERCURY; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SAGE; SCHOENOCAULON OFFICINALE SEED; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 35; 35; 20; 20; 20; 20; 20; 20; 20; 20; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 55714-4424_f886f05e-a0ff-fbe4-8213-f31d1fd99f45 55714-4424 HUMAN PRESCRIPTION DRUG Hypertension Elaps corallinus, Adrenalinum, Arsenicum iodatum , Aur. met., Baryta carb., Bryonia, Cactus, Chelidonium majus, Cinchona, Crotalus horridus, Digitalis, Glonoinum, Kali carb., Kali iod ., Lachesis , Naja , Nux vom., Veratrum alb., Vipera berus, Viscum, Ruta, Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIIODIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; EPINEPHRINE; GOLD; LACHESIS MUTA VENOM; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; NITROGLYCERIN; POTASSIUM CARBONATE; POTASSIUM IODIDE; RUTA GRAVEOLENS FLOWERING TOP; SELENICEREUS GRANDIFLORUS STEM; STRYCHNOS NUX-VOMICA SEED; VALERIAN; VERATRUM ALBUM ROOT; VIPERA BERUS VENOM; VISCUM ALBUM FRUITING TOP 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4425_d0ae71ca-571d-8cd5-9542-93ade77dc7bc 55714-4425 HUMAN PRESCRIPTION DRUG Hypertension Elaps corallinus, Adrenalinum, Arsenicum iodatum , Aur. met., Baryta carb., Bryonia, Cactus, Chelidonium majus, Cinchona, Crotalus horridus, Digitalis, Glonoinum, Kali carb., Kali iod ., Lachesis , Naja , Nux vom., Veratrum alb., Vipera berus, Viscum, Ruta, Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIIODIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; EPINEPHRINE; GOLD; LACHESIS MUTA VENOM; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; NITROGLYCERIN; POTASSIUM CARBONATE; POTASSIUM IODIDE; RUTA GRAVEOLENS FLOWERING TOP; SELENICEREUS GRANDIFLORUS STEM; STRYCHNOS NUX-VOMICA SEED; VALERIAN; VERATRUM ALBUM ROOT; VIPERA BERUS VENOM; VISCUM ALBUM FRUITING TOP 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4426_3a9e31c6-762d-5d31-d974-f8c31e1c6869 55714-4426 HUMAN PRESCRIPTION DRUG Constipation Abies nig., Aesculus hipp., Aloe, Alumina, Bryonia, Carbo veg., Chelidonium majus, Collinsonia, Graphites, Hydrastis, Kali carb., Lycopodium, Mag. mur., Mezereum, Nux vom., Podoph. pelt., Rhamnus purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum alb., Zinc. met., Echinacea, Iris versicolor, Phytolacca, Taraxacum, LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; ECHINACEA, UNSPECIFIED; FRANGULA PURSHIANA BARK; GOLDENSEAL; GRAPHITE; HORSE CHESTNUT; IRIS VERSICOLOR ROOT; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; PHYTOLACCA AMERICANA ROOT; PHYTOLACCA AMERICANA ROOT; PICEA MARIANA RESIN; PODOPHYLLUM; POTASSIUM CARBONATE; SANICULA EUROPAEA WHOLE; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TARAXACUM OFFICINALE; TOBACCO LEAF; VERATRUM ALBUM ROOT; ZINC 20; 20; 20; 20; 20; 20; 20; 3; 8; 20; 20; 20; 20; 3; 8; 20; 20; 3; 8; 20; 20; 20; 20; 20; 20; 20; 20; 3; 8; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 55714-4427_e884e313-298e-fbca-b877-71a3e227b886 55714-4427 HUMAN PRESCRIPTION DRUG Constipation Abies nig., Aesculus hipp., Aloe, Alumina, Bryonia, Carbo veg., Chelidonium majus, Collinsonia, Graphites, Hydrastis, Kali carb., Lycopodium, Mag. mur., Mezereum, Nux vom., Podoph. pelt., Rhamnus purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum alb., Zinc. met., Echinacea, Iris versicolor, Phytolacca, Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; FRANGULA PURSHIANA BARK; GOLDENSEAL; GRAPHITE; HORSE CHESTNUT; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; PHYTOLACCA AMERICANA ROOT; PICEA MARIANA RESIN; PODOPHYLLUM; POTASSIUM CARBONATE; SANICULA EUROPAEA WHOLE; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TOBACCO LEAF; VERATRUM ALBUM ROOT; ZINC 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 8; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 55714-4428_ccc38a3b-5a91-19ed-8eba-cb5832d5c91a 55714-4428 HUMAN PRESCRIPTION DRUG Diabetes Arg. met., Arsenicum alb, Aur. met., Bovista, Bryonia, Chelidonium majus, Chionanthus virginica, Gaultheria procumbens, Helonias dioica, Iris versicolor, Lycopodium, Nux vom, Phosphorus, Rhus toxicodendron, Sabal, Syzygium, Cynara, Echinacea, Iris versicolor, Thuja occ., Urtica ur LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHAMAELIRIUM LUTEUM ROOT; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CYNARA SCOLYMUS LEAF; ECHINACEA, UNSPECIFIED; GAULTHERIA PROCUMBENS TOP; GIANT PUFFBALL; GOLD; IRIS VERSICOLOR ROOT; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SAW PALMETTO; SILVER; STRYCHNOS NUX-VOMICA SEED; SYZYGIUM CUMINI SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 15; 15; 15; 15; 15; 3; 3; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 3; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4429_7d7e957e-22dd-a3a6-810e-1b8883e6e799 55714-4429 HUMAN PRESCRIPTION DRUG Diabetes Arg. met., Arsenicum alb, Aur. met., Bovista, Bryonia, Chelidonium majus, Chionanthus virginica, Gaultheria procumbens, Helonias dioica, Iris versicolor, Lycopodium, Nux vom, Phosphorus, Rhus toxicodendron, Sabal, Syzygium, Cynara, Echinacea, Thuja occ., Urtica ur PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHAMAELIRIUM LUTEUM ROOT; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CYNARA SCOLYMUS LEAF; ECHINACEA, UNSPECIFIED; GAULTHERIA PROCUMBENS TOP; GIANT PUFFBALL; GOLD; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SAW PALMETTO; SILVER; STRYCHNOS NUX-VOMICA SEED; SYZYGIUM CUMINI SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 15; 15; 15; 15; 15; 3; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4430_45cd1364-38bf-b552-545a-a628c3dea4f6 55714-4430 HUMAN PRESCRIPTION DRUG Arthritic Joint Care Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Benzoicum acidum,Bryonia, Calc. carb., Chamomilla, Cinchona, Colchicum, Eupatorium perf., Gaultheria procumbens, Guaiacum, Iodium, Kali bic., Kalmia, Ledum,Pulsatilla, Rhus xicodendron, Ruta, Sabina, Strychninum, Uricum acidum, Lappa, Phytolacca, Symphytum, LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARCTIUM LAPPA ROOT; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GAULTHERIA PROCUMBENS TOP; GUAIAC; IODINE; JUNIPERUS SABINA LEAFY TWIG; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; STRYCHNINE; TOXICODENDRON PUBESCENS LEAF; URIC ACID 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 55714-4431_dc0b72f7-dff4-14d8-1a92-e29dd1960cac 55714-4431 HUMAN PRESCRIPTION DRUG Arthritic - Joint Care Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Benzoicum acidum,Bryonia, Calc. carb., Chamomilla, Cinchona, Colchicum, Eupatorium perf., Gaultheria procumbens, Guaiacum, Iodium, Kali bic., Kalmia, Ledum,Pulsatilla, Rhus xicodendron, Ruta, Sabina, Strychninum, Uricum acidum, Lappa, Phytolacca, Symphytum, PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARCTIUM LAPPA ROOT; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GAULTHERIA PROCUMBENS TOP; GUAIAC; IODINE; JUNIPERUS SABINA LEAFY TWIG; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; STRYCHNINE; TOXICODENDRON PUBESCENS LEAF; URIC ACID 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] 55714-4432_bec9c8bf-a165-fc44-0cb7-691b54d1142d 55714-4432 HUMAN PRESCRIPTION DRUG Hay Fever Zerophyllum asphodeloides, Alfalfa, Avena sativa pollen, Cynosurus cristatus pollen, Echinochloa crus-galli pollen, Poa pratensis pollen, Anthoxanthum odoratum pollen, Agrostis gigantea pollen, Bromus secalinus pollen, Alopecurus pratensis pollen, Phleum pratense pollen, Festuca pratensis pollen, Holcus lanatus pollen, Lolium perenne pollen, Fagus sylvatica pollen, Betula pendula pollen, Quercus alba pollen, Fraxinus excelsior pollen, Corylus americana pollen, Populus nigra pollen LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AGROSTIS GIGANTEA POLLEN; ALFALFA; ALOPECURUS PRATENSIS POLLEN; AMBROSIA ARTEMISIIFOLIA; AMMONIUM CARBONATE; ANTHOXANTHUM ODORATUM POLLEN; APIS MELLIFERA; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; ARUNDO PLINIANA ROOT; AVENA SATIVA POLLEN; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; BETULA PENDULA POLLEN; BROMUS SECALINUS POLLEN; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALLUNA VULGARIS POLLEN; CHELIDONIUM MAJUS; CORYLUS AMERICANA POLLEN; CRATAEGUS MONOGYNA POLLEN; CYNOSURUS CRISTATUS POLLEN; CYTISUS SCOPARIUS POLLEN; DATURA STRAMONIUM; DIANTHUS CARYOPHYLLUS FLOWER; DROSERA ROTUNDIFOLIA; DYSPHANIA AMBROSIOIDES; ECHINACEA, UNSPECIFIED; ECHINOCHLOA CRUS-GALLI POLLEN; ELYMUS REPENS ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; FAGUS SYLVATICA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS EXCELSIOR POLLEN; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; HOLCUS LANATUS POLLEN; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LILIUM CANDIDUM FLOWER; LOLIUM PERENNE POLLEN; LYCOPODIUM CLAVATUM SPORE; NARCISSUS PSEUDONARCISSUS; ONION; ONOSMODIUM VIRGINIANUM WHOLE; PHLEUM PRATENSE POLLEN; PLATANUS ORIENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PRIMULA VULGARIS; PULSATILLA VULGARIS; QUERCUS ALBA POLLEN; ROSA CANINA FLOWER; SALIX ALBA POLLEN; SANGUINARIA CANADENSIS ROOT; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; TRILLIUM ERECTUM ROOT; ULEX EUROPAEUS FLOWER; ULMUS GLABRA POLLEN; URTICA URENS; USTILAGO MAYDIS; WYETHIA HELENIOIDES ROOT; XEROPHYLLUM ASPHODELOIDES 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] 55714-4433_15558d31-b09a-c23d-43f9-c3fb8aa45f7d 55714-4433 HUMAN PRESCRIPTION DRUG Hay Fever Zerophyllum asphodeloides, Alfalfa, Avena sativa pollen, Cynosurus cristatus pollen, Echinochloa crus-galli pollen, Poa pratensis pollen, Anthoxanthum odoratum pollen, Agrostis gigantea pollen, Bromus secalinus pollen, Alopecurus pratensis pollen, Phleum pratense pollen, Festuca pratensis pollen, Holcus lanatus pollen, Lolium perenne pollen, Fagus sylvatica pollen, Betula pendula pollen, Quercus alba pollen, Fraxinus excelsior pollen, Corylus americana pollen, Populus nigra pollen PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AGROSTIS GIGANTEA POLLEN; ALFALFA; ALOPECURUS PRATENSIS POLLEN; AMBROSIA ARTEMISIIFOLIA; AMMONIUM CARBONATE; ANTHOXANTHUM ODORATUM POLLEN; APIS MELLIFERA; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; ARUNDO PLINIANA ROOT; AVENA SATIVA POLLEN; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; BETULA PENDULA POLLEN; BROMUS SECALINUS POLLEN; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALLUNA VULGARIS POLLEN; CHELIDONIUM MAJUS; CORYLUS AMERICANA POLLEN; CRATAEGUS MONOGYNA POLLEN; CYNOSURUS CRISTATUS POLLEN; CYTISUS SCOPARIUS POLLEN; DATURA STRAMONIUM; DIANTHUS CARYOPHYLLUS FLOWER; DROSERA ROTUNDIFOLIA; DYSPHANIA AMBROSIOIDES; ECHINACEA, UNSPECIFIED; ECHINOCHLOA CRUS-GALLI POLLEN; ELYMUS REPENS ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; FAGUS SYLVATICA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS EXCELSIOR POLLEN; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; HOLCUS LANATUS POLLEN; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LILIUM CANDIDUM FLOWER; LOLIUM PERENNE POLLEN; LYCOPODIUM CLAVATUM SPORE; NARCISSUS PSEUDONARCISSUS; ONION; ONOSMODIUM VIRGINIANUM WHOLE; PHLEUM PRATENSE POLLEN; PLATANUS ORIENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PRIMULA VULGARIS; PULSATILLA VULGARIS; QUERCUS ALBA POLLEN; ROSA CANINA FLOWER; SALIX ALBA POLLEN; SANGUINARIA CANADENSIS ROOT; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; TRILLIUM ERECTUM ROOT; ULEX EUROPAEUS FLOWER; ULMUS GLABRA POLLEN; URTICA URENS; USTILAGO MAYDIS; WYETHIA HELENIOIDES ROOT; XEROPHYLLUM ASPHODELOIDES 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] 55714-4438_b006ceaa-4794-5eb1-ded5-138cfadd85c7 55714-4438 HUMAN PRESCRIPTION DRUG Gas Indigestion Pyrogenium, Antimon. crud., Arsenicum alb., Baptisia, Bryonia, Carbo veg.,Chelidonium majus, Cinchona, Colchicum, Daphne indica, Ipecac., Iris versicolor, Kali carb.,Kreosotum, Lachesis, Lycopodium, Mag. carb., Merc. viv, Nux vom., Phosphorus, Pulsatilla, Spigelia anth., Sulphur, Chamomilla, Echinacea, Iris versicolor, Ruta, Taraxacum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; DAPHNE ODORA BARK; ECHINACEA, UNSPECIFIED; IPECAC; IRIS VERSICOLOR ROOT; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; MERCURY; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; RANCID BEEF; RUTA GRAVEOLENS FLOWERING TOP; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE; WOOD CREOSOTE 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 3; 15; 15; 15; 15; 30; 3; 15; 15; 15; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4439_7d22d236-4139-d16e-ca23-fdae0f713f32 55714-4439 HUMAN PRESCRIPTION DRUG Gas - Indigestion Pyrogenium, Antimon. crud., Arsenicum alb., Baptisia, Bryonia, Carbo veg.,Chelidonium majus, Cinchona, Colchicum, Daphne indica, Ipecac., Iris versicolor, Kali carb.,Kreosotum, Lachesis, Lycopodium, Mag. carb., Merc. viv, Nux vom., Phosphorus, Pulsatilla, Spigelia anth., Sulphur, Chamomilla, Echinacea, Ruta, Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; DAPHNE ODORA BARK; ECHINACEA, UNSPECIFIED; IPECAC; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; MERCURY; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; RANCID BEEF; RUTA GRAVEOLENS FLOWERING TOP; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE; WOOD CREOSOTE 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 30; 3; 15; 15; 15; 3; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4440_ad1ee35c-b45f-d330-cec0-c89d14c1bd24 55714-4440 HUMAN PRESCRIPTION DRUG Oral Care - Gingivitis Aconitum nap., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium majus,Crotalus horridus, Gelsemium, Hepar sulph.calc., Kreosotum, Merc. viv., Myrrha, Nux vom., Phosphorus, Phytolacca, Plantago, Rhus toxicodendron, Slicea, Staphysag., Echinacea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA RECUTITA; MERCURY; MYRRH; PHOSPHORUS; PLANTAGO MAJOR; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; WOOD CREOSOTE 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4441_78a5ea44-c3e6-c43d-1ba8-43b141b9efc5 55714-4441 HUMAN PRESCRIPTION DRUG Oral Care - Gingivitis Aconitum nap., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium majus,Crotalus horridus, Gelsemium, Hepar sulph.calc., Kreosotum, Merc. viv., Myrrha, Nux vom., Phosphorus, Phytolacca, Plantago, Rhus toxicodendron, Slicea, Staphysag., Echinacea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA RECUTITA; MERCURY; MYRRH; PHOSPHORUS; PLANTAGO MAJOR; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; WOOD CREOSOTE 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4444_70961b8f-f9ce-5d67-2fc3-c652ac085bac 55714-4444 HUMAN PRESCRIPTION DRUG Headache - Migraine Elaps corallinus, Arsenicum alb., Belladonna, Bryonia, Carduus benedictus, Cimicifuga, Coffea cruda, Convallaria, Crotalus horridus, Digitalis, Gelsemium, Glonoinum, Ignatia, Lachesis, Merc. viv., Naja, Nux vom., Phosphorus, Rhus toxicodendron, Sanguinaria, Secale, Vipera berus, Apis mel., Hypericum, Thuja occ. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CLAVICEPS PURPUREA SCLEROTIUM; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; MERCURY; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; SANGUINARIA CANADENSIS ROOT; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; VIPERA BERUS VENOM 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 30; 15; 15; 15; 15; 15; 15; 3; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4445_ce552a8e-4374-10a3-c8ac-c725fa9c6fa2 55714-4445 HUMAN PRESCRIPTION DRUG Headache - Migraine Elaps corallinus, Arsenicum alb., Belladonna, Bryonia, Carduus benedictus, Cimicifuga, Coffea cruda, Convallaria, Crotalus horridus, Digitalis, Gelsemium, Glonoinum, Ignatia, Lachesis, Merc. viv., Naja, Nux vom., Phosphorus, Rhus toxicodendron, Sanguinaria, Secale, Vipera berus, Apis mel., Hypericum, Thuja occ. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CLAVICEPS PURPUREA SCLEROTIUM; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; MERCURY; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; SANGUINARIA CANADENSIS ROOT; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; VIPERA BERUS VENOM 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 30; 15; 15; 15; 15; 15; 15; 3; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4446_8a1a289b-e2ec-31aa-3039-d9b8967c6660 55714-4446 HUMAN PRESCRIPTION DRUG Hemorrhoids Elaps corallinus, Aesculus hipp., Aloe, Arsenicum alb., Bryonia, Calc. fluor., Capsicum, Collinsonia, Crotalus horridus, Hamamelis, Hydrofluoricum acidum, Hypericum, Lachesis, Lycopodium, Millefolium, Naja, Nux vom., Paeonia, Plantago, Quercus glandium spiritus, Ratanhia, Vipera berus, Aesculus hipp, Echinacea, Solidago, Urtica ur., Aesculus hipp., Echinacea, Solidago, Urtica ur. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACHILLEA MILLEFOLIUM; ALOE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAPSICUM; COLLINSONIA CANADENSIS ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HORSE CHESTNUT; HORSE CHESTNUT; HYDROFLUORIC ACID; HYPERICUM PERFORATUM; KRAMERIA LAPPACEA ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; PAEONIA OFFICINALIS ROOT; PLANTAGO MAJOR; QUERCUS ROBUR NUT; SOLIDAGO VIRGAUREA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; URTICA URENS; URTICA URENS; VIPERA BERUS VENOM 20; 20; 20; 20; 20; 20; 20; 20; 3; 8; 20; 20; 3; 8; 20; 20; 20; 20; 20; 35; 20; 20; 20; 20; 3; 8; 20; 3; 8; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4447_5f9dab33-834a-6417-a20b-2fa3be13e1d2 55714-4447 HUMAN PRESCRIPTION DRUG Hemorrhoids Elaps corallinus, Aesculus hipp., Aloe, Arsenicum alb., Bryonia, Calc. fluor., Capsicum, Collinsonia, Crotalus horridus, Hamamelis, Hydrofluoricum acidum, Hypericum, Lachesis, Lycopodium, Millefolium, Naja, Nux vom., Paeonia, Plantago, Quercus glandium spiritus, Ratanhia, Vipera berus, Echinacea, Solidago, Urtica ur. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACHILLEA MILLEFOLIUM; ALOE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAPSICUM; COLLINSONIA CANADENSIS ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROFLUORIC ACID; HYPERICUM PERFORATUM; KRAMERIA LAPPACEA ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; PAEONIA OFFICINALIS ROOT; PLANTAGO MAJOR; QUERCUS ROBUR NUT; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; URTICA URENS; VIPERA BERUS VENOM 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 35; 20; 20; 20; 20; 8; 20; 8; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4448_5c513c5f-7684-2373-1576-8affbd383cc0 55714-4448 HUMAN PRESCRIPTION DRUG Menstrual - PMS Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga,Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia, Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACHILLEA MILLEFOLIUM; ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BLACK COHOSH; BRYONIA ALBA ROOT; CAPSELLA BURSA-PASTORIS; CAULOPHYLLUM THALICTROIDES ROOT; CINCHONA OFFICINALIS BARK; CLAVICEPS PURPUREA SCLEROTIUM; DIOSCOREA VILLOSA TUBER; ECHINACEA, UNSPECIFIED; ESTRONE; GELSEMIUM SEMPERVIRENS ROOT; GINGER; JUNIPERUS SABINA LEAFY TWIG; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; VALERIAN; VIBURNUM OPULUS BARK 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 55714-4449_2d662d2e-30a9-46c5-6b6e-9159fb909215 55714-4449 HUMAN PRESCRIPTION DRUG Menstrual - PMS Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga,Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia, Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACHILLEA MILLEFOLIUM; ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BLACK COHOSH; BRYONIA ALBA ROOT; CAPSELLA BURSA-PASTORIS; CAULOPHYLLUM THALICTROIDES ROOT; CINCHONA OFFICINALIS BARK; CLAVICEPS PURPUREA SCLEROTIUM; DIOSCOREA VILLOSA TUBER; ECHINACEA, UNSPECIFIED; ESTRONE; GELSEMIUM SEMPERVIRENS ROOT; GINGER; JUNIPERUS SABINA LEAFY TWIG; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; VALERIAN; VIBURNUM OPULUS BARK 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 55714-4450_edb76093-7a4f-418b-379e-d2276ced6c6e 55714-4450 HUMAN PRESCRIPTION DRUG Throat Care Aconitum nap., Apis mel., Arum dracontium, Belladonna, Bryonia, Cajuputum, Ferrum phosphoricum, Glycyrrhiza glabra, Kali bic., Lachesis, Mentha piperita, Merc. viv., Naja, Nat. carb., Nat. sulphuricum, Nitricum ac., Nux vom., Phosphorus, Phytolacca, Pulsatilla, Spongia, Stannum met., Sticta, Thuja occ., Ulmus fulva, Verbascum, Echinacea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARISAEMA DRACONTIUM ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAJUPUT OIL; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GLYCYRRHIZA GLABRA; LACHESIS MUTA VENOM; LOBARIA PULMONARIA; MENTHA PIPERITA; MERCURY; NAJA NAJA VENOM; NITRIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SODIUM CARBONATE; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TIN; ULMUS RUBRA BARK; VERBASCUM THAPSUS 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4451_e1d0ce66-c069-0f7f-dab6-2818ed615efb 55714-4451 HUMAN PRESCRIPTION DRUG Throat Care Aconitum nap., Apis mel., Arum dracontium, Belladonna, Bryonia, Cajuputum, Ferrum phosphoricum, Glycyrrhiza glabra, Kali bic., Lachesis, Mentha piperita, Merc. viv., Naja, Nat. carb., Nat. sulphuricum, Nitricum ac., Nux vom., Phosphorus, Phytolacca, Pulsatilla, Spongia, Stannum met., Sticta, Thuja occ., Ulmus fulva, Verbascum, Echinacea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARISAEMA DRACONTIUM ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAJUPUT OIL; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GLYCYRRHIZA GLABRA; LACHESIS MUTA VENOM; LOBARIA PULMONARIA; MENTHA PIPERITA; MERCURY; NAJA NAJA VENOM; NITRIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SODIUM CARBONATE; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TIN; ULMUS RUBRA BARK; VERBASCUM THAPSUS 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4452_46ffd1dd-d60b-108c-da5f-d09a671b0fd9 55714-4452 HUMAN PRESCRIPTION DRUG Herpes Sores Arsenicum alb., Bryonia, Cantharis, Chelidonium majus, Cistus canadensis, Conium, Croton, Dulcamara, Graphites, Kali bic., Lycopodium, Mezereum, Nux vom., Petroleum, Pulsatilla, Ranunc. bulb., Rhus toxicodendron, Sarsaparilla, Sepia, Sulphur, Thuja occ., Echinacea, Hypericum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GRAPHITE; HELIANTHEMUM CANADENSE; HYPERICUM PERFORATUM; KEROSENE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUICE; SMILAX REGELII ROOT; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 8; 15; 15; 8; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4453_f5614f80-f94f-660d-3beb-c726cbf02426 55714-4453 HUMAN PRESCRIPTION DRUG Herpes Sores Arsenicum alb., Bryonia, Cantharis, Chelidonium majus, Cistus canadensis, Conium, Croton, Dulcamara, Graphites, Kali bic., Lycopodium, Mezereum, Nux vom., Petroleum, Pulsatilla, Ranunc. bulb., Rhus toxicodendron, Sarsaparilla, Sepia, Sulphur, Thuja occ., Echinacea, Hypericum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GRAPHITE; HELIANTHEMUM CANADENSE; HYPERICUM PERFORATUM; KEROSENE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUICE; SMILAX REGELII ROOT; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 8; 15; 15; 8; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4456_4111fe91-80da-1c8f-2d0d-6c6522cc6870 55714-4456 HUMAN PRESCRIPTION DRUG Menopause Elaps corallinus, Agnus, Angelica sinensis radix, Arsenicum alb., Bryonia, Cantharis, Caulophyllum, Cimicifuga, Cinchona, Crotalus horridus, Damiana, Glonoinum, Helonias dioica, Ignatia, Kali carb., Lachesis, Naja, Nux vom., Phosphorus, Pulsatilla, Salix nigra, Sanguinaria, Sepia, Echinacea, Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BLACK COHOSH; BRYONIA ALBA ROOT; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; LYTTA VESICATORIA; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TURNERA DIFFUSA LEAFY TWIG; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 15; 15; 35; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4457_f56bd6cf-ce15-fd0c-445a-ef466b17f933 55714-4457 HUMAN PRESCRIPTION DRUG Menopause Elaps corallinus, Agnus, Angelica sinensis radix, Arsenicum alb., Bryonia, Cantharis, Caulophyllum, Cimicifuga, Cinchona, Crotalus horridus, Damiana, Glonoinum, Helonias dioica, Ignatia, Kali carb., Lachesis, Naja, Nux vom., Phosphorus, Pulsatilla, Salix nigra, Sanguinaria, Sepia, Echinacea, Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BLACK COHOSH; BRYONIA ALBA ROOT; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; LYTTA VESICATORIA; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TURNERA DIFFUSA LEAFY TWIG; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 15; 15; 35; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4458_53d43265-e372-3e25-34ff-cf415a39247b 55714-4458 HUMAN PRESCRIPTION DRUG Cardiac Support Elaps corallinus, Aconitum nap., Arsenicum alb., Aur. met., Baryta carb., Benzoicum acidum, Berber. vulg., Bryonia, Calc. fluor. ,Cantharis, Ceanothus, Chelidonium majus , Chionanthus virginica, Cinchona, Convallaria, Crotalus horridus, Digitalis, Gelsemium , Glonoinum, Hydroflouricum acidum, Kali iodatum, Lachesis, Lycopus virginicus, Naja, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron , Vipera berus, Echinacea, Hypericum,Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BARIUM CARBONATE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GOLD; HYDROFLUORIC ACID; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LYCOPUS VIRGINICUS; LYTTA VESICATORIA; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; POTASSIUM IODIDE; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VALERIAN; VIPERA BERUS VENOM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 3; 10; 10; 10; 30; 10; 10; 10; 10; 10; 10; 10; 3; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4459_aa6fd6d8-21bf-7338-999d-d8b29461cfcb 55714-4459 HUMAN PRESCRIPTION DRUG Cardiac Support Elaps corallinus, Aconitum nap., Arsenicum alb., Aur. met., Baryta carb., Benzoicum acidum, Berber. vulg., Bryonia, Calc. fluor. , Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Convallaria, Crotalus horridus, Digitalis, Gelsemium , Glonoinum, Hydroflouricum acidum, Kali iodatum, Lachesis, Lycopus virginicus, Naja, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron , Vipera berus, Echinacea, Hypericum,Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BARIUM CARBONATE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GOLD; HYDROFLUORIC ACID; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LYCOPUS VIRGINICUS; LYTTA VESICATORIA; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; POTASSIUM IODIDE; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VALERIAN; VIPERA BERUS VENOM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 3; 10; 10; 10; 30; 10; 10; 10; 10; 10; 10; 10; 3; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4460_359be9b3-5733-bb89-dedc-2a54969a367a 55714-4460 HUMAN PRESCRIPTION DRUG Nervousness - Anxiety Aconitum nap., Ambra, Anacardium orientale, Arg.nit., Asafoetida, Bryonia, Chamomilla, Cimicifuga, Coffea cruda, Cypripedium, Gelsemium, Hyoscyamus, Hypericum, Ignatia, Kali phos., Nux vom., Sambucus nig., Strychninum, Theridion, Valeriana, Passiflora LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMBERGRIS; ARABICA COFFEE BEAN; ASAFETIDA; BLACK COHOSH; BRYONIA ALBA ROOT; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; SAMBUCUS NIGRA FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; STRYCHNINE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM; VALERIAN 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4461_dfd192fe-6084-7bad-34de-94fb6210940a 55714-4461 HUMAN PRESCRIPTION DRUG Nervousness - Anxiety Aconitum nap., Ambra, Anacardium orientale, Arg.nit., Asafoetida, Bryonia, Chamomilla, Cimicifuga, Coffea cruda, Cypripedium, Gelsemium, Hyoscyamus, Hypericum, Ignatia, Kali phos., Nux vom., Sambucus nig., Strychninum, Theridion, Valeriana, Passiflora PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMBERGRIS; ARABICA COFFEE BEAN; ASAFETIDA; BLACK COHOSH; BRYONIA ALBA ROOT; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; SAMBUCUS NIGRA FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; STRYCHNINE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM; VALERIAN 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4462_73c5936e-630d-e213-ce08-2e0b5053281a 55714-4462 HUMAN PRESCRIPTION DRUG Neuro - Care Aconitum nap., Arg.nit., Arsenicum alb., Belladonna, Bryonia, Cinchona, Gelsemium, Hypericum, Ignatia, Kalmia, Lachesis, Lycopodium, Mag. phos., Mezereum, Phosphorus, Pulsatilla, Rhus toxicodendron, Stramonium, Strychninum, Verbascum, Chamomilla LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; DAPHNE MEZEREUM BARK; DATURA STRAMONIUM; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; PHOSPHORUS; PULSATILLA VULGARIS; SILVER NITRATE; STRYCHNINE; STRYCHNOS IGNATII SEED; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 55714-4463_e9775327-c47f-8d13-2800-4b3a0a8fe26c 55714-4463 HUMAN PRESCRIPTION DRUG Neuro - Care Aconitum nap., Arg.nit., Arsenicum alb., Belladonna, Bryonia, Cinchona, Gelsemium, Hypericum, Ignatia, Kalmia, Lachesis, Lycopodium, Mag. phos., Mezereum, Phosphorus, Pulsatilla, Rhus toxicodendron, Stramonium, Strychninum, Verbascum, Chamomilla PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; DAPHNE MEZEREUM BARK; DATURA STRAMONIUM; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; PHOSPHORUS; PULSATILLA VULGARIS; SILVER NITRATE; STRYCHNINE; STRYCHNOS IGNATII SEED; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 55714-4464_c2cbd06b-b85a-221f-7ddb-ba542dc4fb5e 55714-4464 HUMAN PRESCRIPTION DRUG Prostate Thyroidinum, Baryta carb., Berber. vulg., Bryonia, Calc. carb., Cinchona, Conium, Digitalis, Ferrum picricum, Hydrastis, Iodium, Lycopodium, Nux vom., Pareira, Pulsatilla, Sabal, Selenium, Staphysag., Thuja occ., Trifolium pratense, Echinacea, Hydrastis, Lappa, Solidago LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARCTIUM LAPPA ROOT; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHONDRODENDRON TOMENTOSUM ROOT; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; DIGITALIS; ECHINACEA, UNSPECIFIED; FERRIC PICRATE; GOLDENSEAL; GOLDENSEAL; IODINE; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SAW PALMETTO; SELENIUM; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER 3; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 3; 10; 10; 10; 10; 10; 10; 3; 10; 10; 15; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4465_2b075b61-ae3e-8007-9080-3cc2566c6335 55714-4465 HUMAN PRESCRIPTION DRUG Prostate Thyroidinum, Baryta carb., Berber. vulg., Bryonia, Calc. carb., Cinchona, Conium, Digitalis, Ferrum picricum, Hydrastis, Iodium, Lycopodium, Nux vom., Pareira, Pulsatilla, Sabal, Selenium, Staphysag., Thuja occ., Trifolium pratense, Echinacea, Lappa, Solidago PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARCTIUM LAPPA ROOT; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHONDRODENDRON TOMENTOSUM ROOT; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; DIGITALIS; ECHINACEA, UNSPECIFIED; FERRIC PICRATE; GOLDENSEAL; IODINE; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SAW PALMETTO; SELENIUM; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER 3; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 15; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 55714-4466_53836e15-5504-2180-13f0-298a35197de4 55714-4466 HUMAN PRESCRIPTION DRUG Bladder - Kidney Apis mel., Berber. vulg., Bryonia, Cantharis, Cinchona, Equisetum hyemale, Ferrum phosphoricum, Gelsemium, Juniperus com., Pareira, Phosphorus, Plantago, Pulsatilla, Sabal, Terebinthina, Uva-ursi, Echinacea, Hydrastis, Lappa, Solidago LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARCTIUM LAPPA ROOT; ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHONDRODENDRON TOMENTOSUM ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EQUISETUM HYEMALE; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; JUNIPERUS COMMUNIS FRUIT; LYTTA VESICATORIA; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; TURPENTINE OIL 20; 8; 20; 20; 20; 20; 20; 8; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 8; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 55714-4467_baaa4fb3-c396-36dc-babb-e254c9e03daa 55714-4467 HUMAN PRESCRIPTION DRUG Bladder - Kidney Apis mel., Berber. vulg., Bryonia, Cantharis, Cinchona, Equisetum hyemale, Ferrum phosphoricum, Gelsemium, Juniperus com., Pareira, Phosphorus, Plantago, Pulsatilla, Sabal, Terebinthina, Uva-ursi, Echinacea, Hydrastis, Lappa, Solidago PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARCTIUM LAPPA ROOT; ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHONDRODENDRON TOMENTOSUM ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EQUISETUM HYEMALE; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; JUNIPERUS COMMUNIS FRUIT; LYTTA VESICATORIA; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; TURPENTINE OIL 20; 8; 20; 20; 20; 20; 20; 8; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 8; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 55714-4468_236b7f55-1e7d-1bdf-e986-e6ca9084b694 55714-4468 HUMAN PRESCRIPTION DRUG Acne Cystic Acne Antimon. crud., Arsenicum alb., Aur. met., Berber. aqui., Bovista, Carbo veg., Causticum, Chelidonium majus, Dulcamara, Graphites, Hepar sulph. calc., Hydrocotyle, Kali brom., Kali iod., Ledum, Lycopodium, Nux vom., Silicea, Sulphur iod., Zinc. met., Echinacea, Juglans regia, Lappa, Taraxacum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; CALCIUM SULFIDE; CAUSTICUM; CENTELLA ASIATICA; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT; GIANT PUFFBALL; GOLD; GRAPHITE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; MAHONIA AQUIFOLIUM ROOT BARK; POTASSIUM BROMIDE; POTASSIUM IODIDE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR IODIDE; TARAXACUM OFFICINALE; ZINC 15; 15; 3; 15; 15; 15; 15; 15; 3; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 55714-4469_6c8ed581-8743-14dd-c7d6-c271d3bad811 55714-4469 HUMAN PRESCRIPTION DRUG Acne - Cystic Acne Antimon. crud., Arsenicum alb., Aur. met., Berber. aqui., Bovista, Carbo veg., Causticum, Chelidonium majus, Dulcamara, Graphites, Hepar sulph. calc., Hydrocotyle, Kali brom., Kali iod., Ledum, Lycopodium, Nux vom., Silicea, Sulphur iod., Zinc. met., Echinacea, Juglans regia, Lappa, Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; CALCIUM SULFIDE; CAUSTICUM; CENTELLA ASIATICA; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT; GIANT PUFFBALL; GOLD; GRAPHITE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; MAHONIA AQUIFOLIUM ROOT BARK; POTASSIUM BROMIDE; POTASSIUM IODIDE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR IODIDE; TARAXACUM OFFICINALE; ZINC 15; 15; 3; 15; 15; 15; 15; 15; 3; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 55714-4472_963bc3ba-c83c-6843-e0e1-ae5199cdc0b9 55714-4472 HUMAN PRESCRIPTION DRUG Varicose Veins - Phlebitis Elaps corallinus, Crotalus horridus, Bryonia, Calc. fluor., Carduus mar., Cholesterinum, Cinchona, Digitalis, Hamamelis, Hydrofluoricum acidum, Lachesis, Lycopodium, Naja, Pulsatilla, Vipera berus, Zinc. met., Aesculus hipp., Echinacea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROFLUORIC ACID; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; PULSATILLA VULGARIS; SILYBUM MARIANUM SEED; VIPERA BERUS VENOM; ZINC 15; 15; 15; 15; 20; 15; 8; 15; 8; 15; 15; 15; 35; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-4473_775c0b06-dfcf-dd18-51c2-777863f97abf 55714-4473 HUMAN PRESCRIPTION DRUG Varicose Veins - Phlebitis Elaps corallinus, Crotalus horridus, Bryonia, Calc. fluor., Carduus mar., Cholesterinum, Cinchona, Digitalis, Hamamelis, Hydrofluoricum acidum, Lachesis, Lycopodium, Naja, Pulsatilla, Vipera berus, Zinc. met., Aesculus hipp., Echinacea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROFLUORIC ACID; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; PULSATILLA VULGARIS; SILYBUM MARIANUM SEED; VIPERA BERUS VENOM; ZINC 15; 15; 15; 15; 20; 15; 8; 15; 8; 15; 15; 15; 35; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-4474_93f84fe4-eccb-3962-d2bd-4325ab216a8a 55714-4474 HUMAN PRESCRIPTION DRUG Insect Bites Pyrogenium, Apis mel., Aranea diadema, Arnica, Arsenicum alb, Azadirachta indica, Bryonia, Caladium seguinum , Calendula, Formica, Grindelia, Hypericum , Lachesis 15x, Latrodectus mactans, Ledum, Mezereum , Nux vom., Pulex irritans, Rhus toxicodendron, Tarentula cubensis, Tarentula hispana, Theridion, Thuja occ., Vespa crabro, Echinacea, Hamamelis Solidago LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARANEUS DIADEMATUS; ARNICA MONTANA; ARSENIC TRIOXIDE; AZADIRACHTA INDICA BARK; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CITHARACANTHUS SPINICRUS; DAPHNE MEZEREUM BARK; DIEFFENBACHIA SEGUINE; ECHINACEA, UNSPECIFIED; FORMICA RUFA; GRINDELIA HIRSUTULA FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; LYCOSA TARANTULA; PULEX IRRITANS; RANCID BEEF; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; VESPA CRABRO 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 30; 3; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4475_6e42839b-29f0-3158-eace-f420a7cfcf29 55714-4475 HUMAN PRESCRIPTION DRUG Insect Bites Pyrogenium, Apis mel., Aranea diadema, Arnica, Arsenicum alb, Azadirachta indica, Bryonia, Caladium seguinum , Calendula, Formica, Grindelia, Hypericum , Lachesis 15x, Latrodectus mactans, Ledum, Mezereum , Nux vom., Pulex irritans, Rhus toxicodendron, Tarentula cubensis, Tarentula hispana, Theridion, Thuja occ., Vespa crabro, Echinacea, Hamamelis Solidago PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARANEUS DIADEMATUS; ARNICA MONTANA; ARSENIC TRIOXIDE; AZADIRACHTA INDICA BARK; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CITHARACANTHUS SPINICRUS; DAPHNE MEZEREUM BARK; DIEFFENBACHIA SEGUINE; ECHINACEA, UNSPECIFIED; FORMICA RUFA; GRINDELIA HIRSUTULA FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; LYCOSA TARANTULA; PULEX IRRITANS; RANCID BEEF; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; VESPA CRABRO 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 30; 3; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4476_e7794125-c3d5-2c9d-01d4-152edfa91390 55714-4476 HUMAN PRESCRIPTION DRUG Poison Ivy Xerophyllum asphodeloides, Aconitum nap., Anacardium occidentale, Apis mel., Bryonia, Cantharis, Croton, Graphites, Grindelia, Mezereum, Nux vom., Ranunc. bulb., Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp., Taraxacum, Urtica ur. LIQUID ORAL 20110701 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANACARDIUM OCCIDENTALE FRUIT; APIS MELLIFERA; BRYONIA ALBA ROOT; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GRAPHITE; GRINDELIA HIRSUTULA FLOWERING TOP; LYTTA VESICATORIA; RANUNCULUS BULBOSUS; RUMEX CRISPUS ROOT; SMILAX REGELII ROOT; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; URTICA URENS; XEROPHYLLUM ASPHODELOIDES 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 15; 3; 15; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4477_dc85be41-7f90-4d68-f98b-b401d3b0c109 55714-4477 HUMAN PRESCRIPTION DRUG Poison Ivy Xerophyllum asphodeloides, Aconitum nap., Anacardium occidentale, Apis mel., Bryonia, Cantharis, Croton, Graphites, Grindelia, Mezereum, Nux vom., Ranunc. bulb., Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp., Taraxacum, Urtica ur. PELLET ORAL 20110701 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANACARDIUM OCCIDENTALE FRUIT; APIS MELLIFERA; BRYONIA ALBA ROOT; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GRAPHITE; GRINDELIA HIRSUTULA FLOWERING TOP; LYTTA VESICATORIA; RANUNCULUS BULBOSUS; RUMEX CRISPUS ROOT; SMILAX REGELII ROOT; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; URTICA URENS; XEROPHYLLUM ASPHODELOIDES 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 15; 3; 15; 3; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4480_8f216336-7446-38b4-4710-a6df2a51c7fd 55714-4480 HUMAN PRESCRIPTION DRUG Sciatica Back Aconitum nap., Ammonium benzoicum, Arsenicum alb., Benzoicum acidum, Bryonia, Causticum, Cinchona, Colchicum, Gnaphalium polycephalum, Iris versicolor, Kali iod., Ledum, Lithium carb., Nux vom., Phytolacca, Rhus toxicodendron, Ruta, Sambucus nig., Strychninum, Hypericum, Urtica ur., Hypericum, Urtica ur. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMMONIUM BENZOATE; ARSENIC TRIOXIDE; BENZOIC ACID; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; HYPERICUM PERFORATUM; HYPERICUM PERFORATUM; IRIS VERSICOLOR ROOT; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; PHYTOLACCA AMERICANA ROOT; POTASSIUM IODIDE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; URTICA URENS; URTICA URENS 20; 20; 20; 20; 20; 20; 20; 20; 3; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Mood Stabilizer [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4481_78b98f9c-a0c4-8ad3-e14c-d5dce417723a 55714-4481 HUMAN PRESCRIPTION DRUG Sciatica - Back Care Aconitum nap., Ammonium benzoicum, Arsenicum alb., Benzoicum acidum, Bryonia, Causticum, Cinchona, Colchicum, Gnaphalium polycephalum, Iris versicolor, Kali iod., Ledum, Lithium carb., Nux vom., Phytolacca, Rhus toxicodendron, Ruta, Sambucus nig., Strychninum, Hypericum, Urtica ur. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMMONIUM BENZOATE; ARSENIC TRIOXIDE; BENZOIC ACID; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; HYPERICUM PERFORATUM; IRIS VERSICOLOR ROOT; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; PHYTOLACCA AMERICANA ROOT; POTASSIUM IODIDE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Mood Stabilizer [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4482_c47576d9-ad2f-787a-681a-ce21407aff17 55714-4482 HUMAN PRESCRIPTION DRUG Parasites Abrotanum, Aesculus hipp., Allium sativum, Arsenicum alb., Artemisia, Baptisia, Cina, Cuprum met., Filix mas, Granatum, Ipecac., Lachesis, Lycopodium, Merc. viv., Naphthalinum, Nat.mur., Nux vom., Pulsatilla, Ratanhia, Ruta, Sabadilla, Santoninum, Silicea, Spigelia anth., Terebinthina, Teucrium marum, Thymolum, Zingiber, Juglans regia LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; ARTEMISIA MARITIMA PRE-FLOWERING TOP; BAPTISIA TINCTORIA ROOT; COPPER; DRYOPTERIS FILIX-MAS ROOT; ENGLISH WALNUT; GARLIC; GINGER; HORSE CHESTNUT; IPECAC; KRAMERIA LAPPACEA ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; NAPHTHALENE; PULSATILLA VULGARIS; PUNICA GRANATUM ROOT BARK; RUTA GRAVEOLENS FLOWERING TOP; SANTONIN; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM; THYMOL; TURPENTINE OIL 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 55714-4483_06fb83d9-c1b8-6a0e-013f-397c801a7095 55714-4483 HUMAN PRESCRIPTION DRUG Parasites Abrotanum, Aesculus hipp., Allium sativum, Arsenicum alb., Artemisia, Baptisia, Cina, Cuprum met., Filix mas, Granatum, Ipecac., Lachesis, Lycopodium, Merc. viv., Naphthalinum, Nat.mur., Nux vom., Pulsatilla, Ratanhia, Ruta, Sabadilla, Santoninum, Silicea, Spigelia anth., Terebinthina, Teucrium marum, Thymolum, Zingiber, Juglans regia PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; ARTEMISIA MARITIMA PRE-FLOWERING TOP; BAPTISIA TINCTORIA ROOT; COPPER; DRYOPTERIS FILIX-MAS ROOT; ENGLISH WALNUT; GARLIC; GINGER; HORSE CHESTNUT; IPECAC; KRAMERIA LAPPACEA ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; NAPHTHALENE; PULSATILLA VULGARIS; PUNICA GRANATUM ROOT BARK; RUTA GRAVEOLENS FLOWERING TOP; SANTONIN; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM; THYMOL; TURPENTINE OIL 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 55714-4484_02727487-41ce-c0d7-610d-8d1e7d6d8e6e 55714-4484 HUMAN PRESCRIPTION DRUG Candidiasis Yeast Adrenalinum, Candida albicans Thyroidinum, Torula cerevisiae, Triticum, Ustilago maidis, Antimon. crud., Arsenicum alb., Baptisia, Berber. aqui, Bryonia Calc. phos., Cinchona, Helonias dioica, Hydrastis, Iodium, Iris versicolor, Kali carb., Lachesis , Lycopodium, Merc. viv., Nat. carb, Nat. phos., Nitricum ac., Phosphorus, Podoph. pelt., Pulsatilla, Sepia, Echinacea, Ginkgo, Juglans regia, Lappa, Thuja occ., Echinacea, Ginkgo, Juglans regia, Lappa, Thuja occ. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CANDIDA ALBICANS; CHAMAELIRIUM LUTEUM ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; ECHINACEA, UNSPECIFIED; ELYMUS REPENS TOP; ENGLISH WALNUT; ENGLISH WALNUT; EPINEPHRINE; GINKGO; GINKGO; GOLDENSEAL; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAHONIA AQUIFOLIUM ROOT BARK; MERCURY; NITRIC ACID; PHOSPHORUS; PODOPHYLLUM; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE; SODIUM CARBONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; THUJA OCCIDENTALIS LEAFY TWIG; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRIBASIC CALCIUM PHOSPHATE; USTILAGO MAYDIS 15; 3; 8; 15; 15; 15; 20; 15; 15; 3; 8; 20; 3; 8; 20; 3; 8; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 20; 15; 15; 15; 3; 8; 20; 15; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 55714-4485_2af876c8-4f1a-9504-7022-5f0844ba0ed0 55714-4485 HUMAN PRESCRIPTION DRUG Candidiasis - Yeast Adrenalinum, Candida albicans Thyroidinum, Torula cerevisiae, Triticum, Ustilago maidis, Antimon. crud., Arsenicum alb., Baptisia, Berber. aqui, Bryonia Calc. phos., Cinchona, Helonias dioica, Hydrastis, Iodium, Iris versicolor, Kali carb., Lachesis , Lycopodium, Merc. viv., Nat. carb, Nat. phos., Nitricum ac., Phosphorus, Podoph. pelt., Pulsatilla, Sepia, Echinacea, Ginkgo, Juglans regia, Lappa, Thuja occ. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CANDIDA ALBICANS; CHAMAELIRIUM LUTEUM ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; ELYMUS REPENS ROOT; ENGLISH WALNUT; EPINEPHRINE; GINKGO; GOLDENSEAL; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAHONIA AQUIFOLIUM ROOT BARK; MERCURY; NITRIC ACID; PHOSPHORUS; PODOPHYLLUM; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE; SODIUM CARBONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRIBASIC CALCIUM PHOSPHATE; USTILAGO MAYDIS 15; 8; 15; 15; 15; 20; 15; 15; 8; 20; 8; 20; 8; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 20; 15; 15; 15; 8; 20; 15; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 55714-4486_646483d3-fb37-59bd-c0f8-abdb22388ad2 55714-4486 HUMAN PRESCRIPTION DRUG Vaginitis - Feminine Care Agaricus musc., Arsenicum alb., Aur. met, Berber. aqui., Caladium seguinum, Candida albicans, Cantharis, Conium, Graphites, Helonias dioica, Hydrastis, Kali carb., Kreosotum, Lycopodium, Merc. viv., Murex purpurea, Nat. mur, Nitricum ac., Pulsatilla, Rhus toxicodendron, Sepia, Sulphur, Tarentula hispana, Thuja occ., Zinc. met., Apis mel, Hamamelis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; APIS MELLIFERA; ARSENIC TRIOXIDE; CANDIDA ALBICANS; CHAMAELIRIUM LUTEUM ROOT; CONIUM MACULATUM FLOWERING TOP; DIEFFENBACHIA SEGUINE; GOLD; GOLDENSEAL; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; LYTTA VESICATORIA; MAHONIA AQUIFOLIUM ROOT BARK; MERCURY; NITRIC ACID; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; WOOD CREOSOTE; ZINC 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4487_2c67cb15-4a93-89a8-bf3e-86a0dc0a0a08 55714-4487 HUMAN PRESCRIPTION DRUG Vaginitis - Feminine Care Agaricus musc., Arsenicum alb., Aur. met, Berber. aqui., Caladium seguinum, Candida albicans, Cantharis, Conium, Graphites, Helonias dioica, Hydrastis, Kali carb., Kreosotum, Lycopodium, Merc. viv., Murex purpurea, Nat. mur, Nitricum ac., Pulsatilla, Rhus toxicodendron, Sepia, Sulphur, Tarentula hispana, Thuja occ., Zinc. met., Apis mel, Hamamelis PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; APIS MELLIFERA; ARSENIC TRIOXIDE; CANDIDA ALBICANS; CHAMAELIRIUM LUTEUM ROOT; CONIUM MACULATUM FLOWERING TOP; DIEFFENBACHIA SEGUINE; GOLD; GOLDENSEAL; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; LYTTA VESICATORIA; MAHONIA AQUIFOLIUM ROOT BARK; MERCURY; NITRIC ACID; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; WOOD CREOSOTE; ZINC 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4490_70e44871-0661-43dc-dee9-b199d03e7d11 55714-4490 HUMAN PRESCRIPTION DRUG Vaccination - Illness Assist Influenzinum, Morbillinum, Pertussinum, Aconitum nap., Alumina, Antimon. tart., Arsenicum alb., Baptisia, Belladonna, Bryonia, Cinchona, Crotalus horridus, Gelsemium, Kali bic., Lachesis, Ledum, Merc. viv., Mezereum, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Silicea, Sulphur, Thuja occ., Vaccinium, Apis mel., Echinacea, Hypericum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALUMINUM OXIDE; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA; BILBERRY; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; HYPERICUM PERFORATUM; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; MEASLES VIRUS; MERCURY; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 8; 15; 15; 15; 15; 15; 15; 15; 15; 8; 15; 35; 8; 35; 35; 15; 15; 35; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4491_5f2b94a0-dfe6-dbaf-ea73-32543078479f 55714-4491 HUMAN PRESCRIPTION DRUG Vaccination - Illness Assist Influenzinum, Morbillinum, Pertussinum, Aconitum nap., Alumina, Antimon. tart., Arsenicum alb., Baptisia, Belladonna, Bryonia, Cinchona, Crotalus horridus, Gelsemium, Kali bic., Lachesis, Ledum, Merc. viv., Mezereum, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Silicea, Sulphur, Thuja occ., Vaccinium, Apis mel., Echinacea, Hypericum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALUMINUM OXIDE; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA; BILBERRY; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; HYPERICUM PERFORATUM; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; MEASLES VIRUS; MERCURY; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 8; 15; 15; 15; 15; 15; 15; 15; 15; 8; 15; 35; 8; 35; 35; 15; 15; 35; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4492_2ca8da63-7a6e-f813-44fb-21b443fe430c 55714-4492 HUMAN PRESCRIPTION DRUG Edometriosis Arsenicum alb., Bryonia, Cimicifuga, Cinchona, Conium, Hydrastis, Iodium, Lachesis, Lilium, Lycopodium, Phosphorus, Pulsatilla, Rhus toxicodendron, Sabina, Secale, Sepia, Apis mel., Hamamelis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; BLACK COHOSH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; IODINE; JUNIPERUS SABINA LEAFY TWIG; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; TOXICODENDRON PUBESCENS LEAF 3; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4493_3fe1168c-268d-2f98-9798-81ce0f234b10 55714-4493 HUMAN PRESCRIPTION DRUG Edometriosis Arsenicum alb., Bryonia, Cimicifuga, Cinchona, Conium, Hydrastis, Iodium, Lachesis, Lilium, Lycopodium, Phosphorus, Pulsatilla, Rhus toxicodendron, Sabina, Secale, Sepia, Apis mel., Hamamelis PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; BLACK COHOSH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; IODINE; JUNIPERUS SABINA LEAFY TWIG; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; TOXICODENDRON PUBESCENS LEAF 3; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4500_a808f93b-2c12-1800-0eab-228182dbbbda 55714-4500 HUMAN PRESCRIPTION DRUG Muscle - Tendon Aconitum nap., Antimon. tart., Arg. nit., Arnica, Bryonia, Chamomilla, Chelidonium majus, Cimicifuga, Eupatorium perf., Hypericum, Nux vom., Rhus toxicodendron, Ruta, Sarcolacticum ac., Stramonium, Strychninum, Phytolacca, Symphytum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BLACK COHOSH; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COMFREY ROOT; DATURA STRAMONIUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; HYPERICUM PERFORATUM; LACTIC ACID, L-; MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE; STRYCHNINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4501_8b569640-8345-6f55-fbdd-054b2b0da2f7 55714-4501 HUMAN PRESCRIPTION DRUG Muscle - Tendon Aconitum nap., Antimon. tart., Arg. nit., Arnica, Bryonia, Chamomilla, Chelidonium majus, Cimicifuga, Eupatorium perf., Hypericum, Nux vom., Rhus toxicodendron, Ruta, Sarcolacticum ac., Stramonium, Strychninum, Phytolacca, Symphytum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BLACK COHOSH; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COMFREY ROOT; DATURA STRAMONIUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; HYPERICUM PERFORATUM; LACTIC ACID, L-; MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE; STRYCHNINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4502_d1c00990-2c01-d86f-bd89-6c761056cfef 55714-4502 HUMAN PRESCRIPTION DRUG Inflammation - Fever Anthracinum, Pyrogenium, Aconitum nap., Aloe, Apis mel., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chelidonium majus, Crotalus horridus, Ferrum phosphoricum, Gaultheria procumbens, Hepar sulph. calc., Iodium, Lachesis, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Veratrum viride, Verbascum, Echinacea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALOE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GAULTHERIA PROCUMBENS TOP; IODINE; LACHESIS MUTA VENOM; LYTTA VESICATORIA; PHOSPHORUS; PULSATILLA VULGARIS; RANCID BEEF; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VERATRUM VIRIDE ROOT; VERBASCUM THAPSUS 20; 20; 20; 20; 20; 20; 35; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 35; 20; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4503_ecb5224c-16a8-fdfe-0d2f-ba8a997b4572 55714-4503 HUMAN PRESCRIPTION DRUG Inflammation - Fever Anthracinum, Pyrogenium, Aconitum nap., Aloe, Apis mel., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chelidonium majus, Crotalus horridus, Ferrum phosphoricum, Gaultheria procumbens, Hepar sulph. calc., Iodium, Lachesis, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Veratrum viride, Verbascum, Echinacea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALOE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GAULTHERIA PROCUMBENS TOP; IODINE; LACHESIS MUTA VENOM; LYTTA VESICATORIA; PHOSPHORUS; PULSATILLA VULGARIS; RANCID BEEF; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VERATRUM VIRIDE ROOT; VERBASCUM THAPSUS 20; 20; 20; 20; 20; 20; 35; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 35; 20; 20; 20; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4504_4b612dec-6226-8bbc-bb57-c902bf2d69e7 55714-4504 HUMAN PRESCRIPTION DRUG Injury - Rescue Aconitum nap., Arnica, Bellis , Calendula , Echinacea, Gelsemium, Hamamelis, Hypericum , Ledum, Phosphorus, Rhus toxicodendron, Ruta, Staphysag., Symphytum, Hydrastis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20 [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-4505_3d30e6a0-3f7a-9434-453e-8d4898fba03c 55714-4505 HUMAN PRESCRIPTION DRUG Injury - Rescue Aconitum nap., Arnica, Bellis , Calendula , Echinacea, Gelsemium, Hamamelis, Hypericum , Ledum, Phosphorus, Rhus toxicodendron, Ruta, Staphysag., Symphytum, Hydrastis PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-4506_c8a13ce2-5e25-2b64-7cf1-dcbb9ea8b3db 55714-4506 HUMAN PRESCRIPTION DRUG Breast Care - Fibrocystic Bufo rana, Apis mel., Asterias rubens, Belladonna, Bryonia, Calc. carb.,Chamomilla, Chimaphila umbellata, Cinchona, Conium, Croton, Echinacea, Graphites, Helonias dioica, Lachesis, Merc. viv., Phellandrium aquaticum, Phosphorus, Phytolacca, Pulsatilla, Sanguinaria, Silicea, Hamamelis, Ruta, Taraxacum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ASTERIAS RUBENS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; BUFO BUFO CUTANEOUS GLAND; CHAMAELIRIUM LUTEUM ROOT; CHIMAPHILA UMBELLATA; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; ECHINACEA, UNSPECIFIED; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MERCURY; OENANTHE AQUATICA FRUIT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; TARAXACUM OFFICINALE 10; 10; 10; 10; 15; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4507_c8f3058b-7272-1888-c48c-95bc212e8b31 55714-4507 HUMAN PRESCRIPTION DRUG Breast Care - Fibrocystic Bufo rana, Apis mel., Asterias rubens, Belladonna, Bryonia, Calc. carb.,Chamomilla, Chimaphila umbellata, Cinchona, Conium, Croton, Echinacea, Graphites, Helonias dioica, Lachesis, Merc. viv., Phellandrium aquaticum, Phosphorus, Phytolacca, Pulsatilla, Sanguinaria, Silicea, Hamamelis, Ruta, Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ASTERIAS RUBENS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; BUFO BUFO CUTANEOUS GLAND; CHAMAELIRIUM LUTEUM ROOT; CHIMAPHILA UMBELLATA; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; ECHINACEA, UNSPECIFIED; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MERCURY; OENANTHE AQUATICA FRUIT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; TARAXACUM OFFICINALE 10; 10; 10; 10; 15; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4508_24f89fb0-b485-42ba-f060-264f60505616 55714-4508 HUMAN PRESCRIPTION DRUG Dizziness - Vertigo Absinthium, Aconitum nap., Antimon. tart., Belladonna, Bryonia, Carbolicum acidum, Colchicum, Conium, Ferrum metallicum, Gelsemium, Glonoinum, Hyoscyamus, Ipecac., Iris versicolor, Lycopodium, Nux vom., Petroleum, Phosphorus, Sepia, Symphoricarpus racemosus, Tabacum, Theridion, Zingiber, Echinacea, Hypericum, Passiflora, Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GINGER; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; IPECAC; IRIS VERSICOLOR ROOT; IRON; KEROSENE; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; PASSIFLORA INCARNATA FLOWERING TOP; PHENOL; PHOSPHORUS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SYMPHORICARPOS ALBUS FRUIT; THERIDION CURASSAVICUM; TOBACCO LEAF; VALERIAN; WORMWOOD 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 8; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4509_49890bd2-de92-ef17-3c9d-94733802f0ae 55714-4509 HUMAN PRESCRIPTION DRUG Dizziness - Vertigo Absinthium, Aconitum nap., Antimon. tart., Belladonna, Bryonia, Carbolicum acidum, Colchicum, Conium, Ferrum metallicum, Gelsemium, Glonoinum, Hyoscyamus, Ipecac., Iris versicolor, Lycopodium, Nux vom., Petroleum, Phosphorus, Sepia, Symphoricarpus racemosus, Tabacum, Theridion, Zingiber, Echinacea, Hypericum, Passiflora, Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GINGER; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; IPECAC; IRIS VERSICOLOR ROOT; IRON; KEROSENE; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; PASSIFLORA INCARNATA FLOWERING TOP; PHENOL; PHOSPHORUS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SYMPHORICARPOS ALBUS FRUIT; THERIDION CURASSAVICUM; TOBACCO LEAF; VALERIAN; WORMWOOD 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 8; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 55714-4510_32ce4364-81f7-08c8-9825-24c160260e63 55714-4510 HUMAN PRESCRIPTION DRUG Digestive Care Antimon. crud., Arg. nit., Arsenicum alb., Baptisia, Bismuthum metallicum, Bryonia, Chamomilla, Cinchona, Iris versicolor, Kali bic., Lachesis, Lycopodium, Mag. carb., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Raphanus, Rhus toxicodendron, Tabacum, Verbascum, Zingiber, Echinacea, Juglans regia LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; DAIKON; ECHINACEA, UNSPECIFIED; GINGER; IRIS VERSICOLOR ROOT; JUGLANS REGIA FRUIT RIND, IMMATURE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; PHOSPHORUS; PODOPHYLLUM; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 55714-4511_ab85aeec-7366-71e9-6472-2a6bd133d607 55714-4511 HUMAN PRESCRIPTION DRUG Digestive Care Antimon. crud., Arg. nit., Arsenicum alb., Baptisia, Bismuthum metallicum, Bryonia, Chamomilla, Cinchona, Iris versicolor, Kali bic., Lachesis, Lycopodium, Mag. carb., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Raphanus, Rhus toxicodendron, Tabacum, Verbascum, Zingiber, Echinacea, Juglans regia PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; DAIKON; ECHINACEA, UNSPECIFIED; GINGER; IRIS VERSICOLOR ROOT; JUGLANS REGIA FRUIT RIND, IMMATURE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; PHOSPHORUS; PODOPHYLLUM; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 55714-4512_e695d8dc-739f-d34e-1afa-9d353f9ec8a0 55714-4512 HUMAN PRESCRIPTION DRUG Hypoglycemia Adrenalinum, Arg. nit.,Arsenicum alb., Bryonia, Cinchona, Graphites,Iodium, Iris versicolor, Lachesis, Lycopodium, Nat. mur., Phosphorus, Phytolacca, Sulphur,Thyroidinum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; EPINEPHRINE; GRAPHITE; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SILVER NITRATE; SODIUM CHLORIDE; SULFUR; THYROID, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55714-4513_a171c4dd-5bf6-0fd7-6dab-47ccd0339610 55714-4513 HUMAN PRESCRIPTION DRUG Hypoglycemia Adrenalinum, Arg. nit.,Arsenicum alb., Bryonia, Cinchona, Graphites,Iodium, Iris versicolor, Lachesis, Lycopodium, Nat. mur., Phosphorus, Phytolacca, Sulphur,Thyroidinum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; EPINEPHRINE; GRAPHITE; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SILVER NITRATE; SODIUM CHLORIDE; SULFUR; THYROID, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55714-4518_47ce6506-a504-b6bc-134f-ed96e532af6e 55714-4518 HUMAN PRESCRIPTION DRUG Libido Agnus, Aralia quinquefolia, Baryta carb., Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Causticum, Chelidonium majus, Cinchona, Conium, Gaultheria procumbens, Graphites, Kali carb., Lycopodium, Nux vom., Onosmodium virginianum, Phosphorus, Sabal, Selenium, Sepia, Silicea, Staphysag., Hydrastis, Thuja occ. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMERICAN GINSENG; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CAUSTICUM; CHASTE TREE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; GAULTHERIA PROCUMBENS TOP; GOLDENSEAL; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; ONOSMODIUM VIRGINIANUM ROOT; PHOSPHORUS; POTASSIUM CARBONATE; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4519_6ae9677b-4a02-beee-d1c7-2a8a45bb3e28 55714-4519 HUMAN PRESCRIPTION DRUG Libido Agnus, Aralia quinquefolia, Baryta carb., Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Causticum, Chelidonium majus, Cinchona, Conium, Gaultheria procumbens, Graphites, Kali carb., Lycopodium, Nux vom., Onosmodium virginianum, Phosphorus, Sabal, Selenium, Sepia, Silicea, Staphysag., Hydrastis, Thuja occ. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMERICAN GINSENG; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CAUSTICUM; CHASTE TREE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; GAULTHERIA PROCUMBENS TOP; GOLDENSEAL; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; ONOSMODIUM VIRGINIANUM ROOT; PHOSPHORUS; POTASSIUM CARBONATE; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4520_1bfd88ef-e0ef-7e9d-3ce8-3db9d1c5836b 55714-4520 HUMAN PRESCRIPTION DRUG Menorrhagia Aletris, Apocynum, Cinchona, Cinnamomum, Conium, Helonias dioica, Lilium, Millefolium, Phosphorus, Secale, Thlaspi, Trillium pendulum, Apis mel., Hamamelis, Hydrastis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACHILLEA MILLEFOLIUM; ALETRIS FARINOSA ROOT; APIS MELLIFERA; APOCYNUM CANNABINUM ROOT; CAPSELLA BURSA-PASTORIS; CHAMAELIRIUM LUTEUM ROOT; CINCHONA OFFICINALIS BARK; CINNAMON; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LILIUM LANCIFOLIUM WHOLE FLOWERING; PHOSPHORUS; TRILLIUM ERECTUM ROOT 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 3; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4521_bafa54f7-58e2-4499-46df-321ada366b7d 55714-4521 HUMAN PRESCRIPTION DRUG Menorrhagia Aletris, Apocynum, Cinchona, Cinnamomum, Conium, Helonias dioica, Lilium, Millefolium, Phosphorus, Secale, Thlaspi, Trillium pendulum, Apis mel., Hamamelis, Hydrastis PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACHILLEA MILLEFOLIUM; ALETRIS FARINOSA ROOT; APIS MELLIFERA; APOCYNUM CANNABINUM ROOT; CAPSELLA BURSA-PASTORIS; CHAMAELIRIUM LUTEUM ROOT; CINCHONA OFFICINALIS BARK; CINNAMON; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LILIUM LANCIFOLIUM WHOLE FLOWERING; PHOSPHORUS; TRILLIUM ERECTUM ROOT 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 3; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4528_9b569529-3b0b-568d-c042-07401519e738 55714-4528 HUMAN PRESCRIPTION DRUG Urticaria - Rashes Antimon. crud., Apis mel., Arsenicum alb., Berber. vulg., Bovista, Bryonia, Cantharis, Chelidonium majus, Croton, Dulcamara, Graphites, Histaminum hydrochloricum, Lycopodium, Mezereum , Nux vom., Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp., Taraxacum, Urtica ur. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GIANT PUFFBALL; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; KEROSENE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PULEX IRRITANS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SMILAX REGELII ROOT; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4529_45be7737-ffd6-b42b-a989-26a101697b54 55714-4529 HUMAN PRESCRIPTION DRUG Urticaria - Rashes Antimon. crud., Apis mel., Arsenicum alb., Berber. vulg., Bovista, Bryonia, Cantharis, Chelidonium majus, Croton, Dulcamara, Graphites, Histaminum hydrochloricum, Lycopodium, Mezereum , Nux vom., Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp., Taraxacum, Urtica ur. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GIANT PUFFBALL; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; KEROSENE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PULEX IRRITANS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SMILAX REGELII ROOT; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4530_6dd93b7b-88db-9c2b-af29-33bfd4c91a29 55714-4530 HUMAN PRESCRIPTION DRUG Gastritis - Ulcer Antimon. crud., Arg. nit., Arsenicum alb., Baptisia, Bismuthum metallicum, Bryonia, Cinchona, Colocynthis, Graphites, Hepar sulph. calc., Hydrastis, Ipecac., Kali bic., Kali carb., Lycopodium, Mag. carb. Mag. phos., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris versicolor, Ruta,Taraxacum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BISMUTH; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; ECHINACEA, UNSPECIFIED; GINGER; GOLDENSEAL; GRAPHITE; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; PHOSPHORUS; PODOPHYLLUM; POTASSIUM CARBONATE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 15; 3; 15; 15; 15; 15; 15; 3; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 55714-4531_07b513e4-38e3-49c8-d444-85752ad9d613 55714-4531 HUMAN PRESCRIPTION DRUG Gastritis - Ulcer Antimon. crud., Arg. nit., Arsenicum alb., Baptisia, Bismuthum metallicum, Bryonia, Cinchona, Colocynthis, Graphites, Hepar sulph. calc., Hydrastis, Ipecac., Kali bic., Kali carb., Lycopodium, Mag. carb. Mag. phos., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris versicolor, Ruta,Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BISMUTH; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; ECHINACEA, UNSPECIFIED; GINGER; GOLDENSEAL; GRAPHITE; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; PHOSPHORUS; PODOPHYLLUM; POTASSIUM CARBONATE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 15; 3; 15; 15; 15; 15; 15; 3; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 55714-4532_bde2200e-ad1f-7422-20ff-78c6aff836cb 55714-4532 HUMAN PRESCRIPTION DRUG Warts - Moles - Skin Tags Antimon. crud., Bryonia, Calc.carb., Causticum, Dulcamara, Graphites, Lycopodium, Merc. sulph. rub., Nat. carb., Nitricum ac., Nux vom., Rhus toxicodendron, Sabina, Sepia, Silicea, Staphysag., Sulphur, Thuja occ.,Taraxacum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; BRYONIA ALBA ROOT; CAUSTICUM; DELPHINIUM STAPHISAGRIA SEED; GRAPHITE; JUNIPERUS SABINA LEAFY TWIG; LYCOPODIUM CLAVATUM SPORE; MERCURIC SULFIDE; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CARBONATE; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4533_af04301f-424e-b8ea-810b-1569d3e1d05a 55714-4533 HUMAN PRESCRIPTION DRUG Warts - Moles - Skin Tags Antimon. crud., Bryonia, Calc.carb., Causticum, Dulcamara, Graphites, Lycopodium, Merc. sulph. rub., Nat. carb., Nitricum ac., Nux vom., Rhus toxicodendron, Sabina, Sepia, Silicea, Staphysag., Sulphur, Thuja occ.,Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; BRYONIA ALBA ROOT; CAUSTICUM; DELPHINIUM STAPHISAGRIA SEED; GRAPHITE; JUNIPERUS SABINA LEAFY TWIG; LYCOPODIUM CLAVATUM SPORE; MERCURIC SULFIDE; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CARBONATE; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4534_326474d5-5ba2-157c-4973-5a53dd8deddc 55714-4534 HUMAN PRESCRIPTION DRUG Incontinence Aloe, Arg. nit., Arsenicum alb., Belladonna, Benzoicum acidum, Bryonia, Cantharis, Causticum, Equisetum hyemale, Ferrum metallicum, Gelsemium, Ignatia, Kali phos., Lycopodium, Nat. mur., Nitricum ac., Plantago, Pulsatilla, Rhus aromatica, Sabal, Secale, Sepia, Staphysag., Stramonium, Thyroidinum, Verbascum, Echinacea, Hydrastis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BRYONIA ALBA ROOT; CAUSTICUM; CLAVICEPS PURPUREA SCLEROTIUM; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; EQUISETUM HYEMALE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; IRON; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; NITRIC ACID; PLANTAGO MAJOR; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; RHUS AROMATICA ROOT BARK; SAW PALMETTO; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THYROID, UNSPECIFIED; VERBASCUM THAPSUS 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] 55714-4535_5f134a6e-33a9-a70a-b9b2-b18fedd1aac7 55714-4535 HUMAN PRESCRIPTION DRUG Incontinence Aloe, Arg. nit., Arsenicum alb., Belladonna, Benzoicum acidum, Bryonia, Cantharis, Causticum, Equisetum hyemale, Ferrum metallicum, Gelsemium, Ignatia, Kali phos., Lycopodium, Nat. mur., Nitricum ac., Plantago, Pulsatilla, Rhus aromatica, Sabal, Secale, Sepia, Staphysag., Stramonium, Thyroidinum, Verbascum, Echinacea, Hydrastis PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BRYONIA ALBA ROOT; CAUSTICUM; CLAVICEPS PURPUREA SCLEROTIUM; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; EQUISETUM HYEMALE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; IRON; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; NITRIC ACID; PLANTAGO MAJOR; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; RHUS AROMATICA ROOT BARK; SAW PALMETTO; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THYROID, UNSPECIFIED; VERBASCUM THAPSUS 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] 55714-4536_ec91015d-4811-baa8-13e0-e6ad28ecb103 55714-4536 HUMAN PRESCRIPTION DRUG Appetite - Craving Control Anacardium orientale, Antimon. crud., Arg. nit., Berber. vulg., Bryonia, Chelidonium majus, Digitalis, Graphites, Humulus, Iris versicolor, Kali carb., Lycopodium, Nat. carb. , Nat. sulphuricum, Nux vom., Pulsatilla, Rhus toxicodendron, Scutellaria lateriflora, Sepia, Stramonium, Chamomilla, Passiflora, Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DATURA STRAMONIUM; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VALERIAN 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4537_2a8331b4-1750-5c3b-7983-67177fa0c68c 55714-4537 HUMAN PRESCRIPTION DRUG Appetite - Craving Control Anacardium orientale, Antimon. crud., Arg. nit., Berber. vulg., Bryonia, Chelidonium majus, Digitalis, Graphites, Humulus, Iris versicolor, Kali carb., Lycopodium, Nat. carb. , Nat. sulphuricum, Nux vom., Pulsatilla, Rhus toxicodendron, Scutellaria lateriflora, Sepia, Stramonium, Chamomilla, Passiflora, Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DATURA STRAMONIUM; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VALERIAN 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4538_8553afde-ca53-f656-5b7a-2a6e6e6a1b07 55714-4538 HUMAN PRESCRIPTION DRUG Tobacco Withdrawal Arsenicum alb., Benzoicum acidum, Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Daphne indica, Ignatia, Iris versicolor, Lycopodium, Nicotinum, Nux vom., Rhus toxicodendron, Scutellaria lateriflora, Tabacum, Echinacea, Taraxacum, Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DAPHNE ODORA BARK; DIEFFENBACHIA SEGUINE; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; NICOTINE; SCUTELLARIA LATERIFLORA; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 55714-4539_fc6a6782-07d2-6831-d766-daad5d6e6d53 55714-4539 HUMAN PRESCRIPTION DRUG Tobacco Withdrawal Arsenicum alb., Benzoicum acidum, Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Daphne indica, Ignatia, Iris versicolor, Lycopodium, Nicotinum, Nux vom., Rhus toxicodendron, Scutellaria lateriflora, Tabacum, Echinacea, Taraxacum, Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DAPHNE ODORA BARK; DIEFFENBACHIA SEGUINE; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; NICOTINE; SCUTELLARIA LATERIFLORA; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 55714-4540_16559fb3-cbb0-67fd-91aa-1862f0bfa2dd 55714-4540 HUMAN PRESCRIPTION DRUG Hyperactivity - Mental Focus Adrenalinum, Tarentula cubensis, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Chamomilla, Cypripedium, Digitalis, Gelsemium, Humulus, Ignatia, Impatiens glandulifera flos, Iodium, Lachesis, Lycopodium, Nat. mur., Nux vom., Scutellaria lateriflora, Staphysag., Stramonium, Theridion, Echinacea, Gingko, Hypericum, Passiflora LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; CITHARACANTHUS SPINICRUS; CYPRIPEDIUM PARVIFOLUM ROOT; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; DIGITALIS; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; HOPS; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM 15; 15; 15; 20; 15; 15; 15; 15; 8; 20; 15; 8; 15; 8; 15; 15; 15; 15; 15; 8; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4541_47c80df1-280e-47d6-e72c-6debd31bd812 55714-4541 HUMAN PRESCRIPTION DRUG Hyperactivity - Mental Focus Adrenalinum, Tarentula cubensis, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Chamomilla, Cypripedium, Digitalis, Gelsemium, Humulus, Ignatia, Impatiens glandulifera flos, Iodium, Lachesis, Lycopodium, Nat. mur., Nux vom., Scutellaria lateriflora, Staphysag., Stramonium, Theridion, Echinacea, Gingko, Hypericum, Passiflora PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; CITHARACANTHUS SPINICRUS; CYPRIPEDIUM PARVIFOLUM ROOT; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; DIGITALIS; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; HOPS; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM 15; 15; 15; 20; 15; 15; 15; 15; 8; 20; 15; 8; 15; 8; 15; 15; 15; 15; 15; 8; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4542_c6955cda-507a-4d07-3927-3d5e2564335e 55714-4542 HUMAN PRESCRIPTION DRUG Edema Elaps corallinus , Apis mel., Arsenicum alb. , Cantharis, Cinchona , Colchicum , Convallaria , Crotalus horridus , Digitalis , Juniperus com , Lachesis , Merc. viv. , Naja , Nat. carb. , Nat. sulphuricum , Rhus toxicodendron , Sambucus nig. , Strophanthus hispidus , Thuja occ. , Vipera berus , Echinacea , Lappa , Solidago , Taraxacum , Urtica ur. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; ECHINACEA, UNSPECIFIED; JUNIPERUS COMMUNIS FRUIT; LACHESIS MUTA VENOM; LYTTA VESICATORIA; MERCURY; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; SAMBUCUS NIGRA FLOWERING TOP; SODIUM CARBONATE; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; URTICA URENS; VIPERA BERUS VENOM 15; 8; 15; 15; 15; 15; 15; 15; 8; 15; 15; 15; 15; 35; 15; 15; 15; 15; 8; 15; 8; 15; 15; 8; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 55714-4543_348f1453-cf15-7ab3-749f-ff983025085d 55714-4543 HUMAN PRESCRIPTION DRUG Edema Elaps corallinus , Apis mel., Arsenicum alb. , Cantharis, Cinchona , Colchicum , Convallaria , Crotalus horridus , Digitalis , Juniperus com , Lachesis , Merc. viv. , Naja , Nat. carb. , Nat. sulphuricum , Rhus toxicodendron , Sambucus nig. , Strophanthus hispidus , Thuja occ. , Vipera berus , Echinacea , Lappa , Solidago , Taraxacum , Urtica ur. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; ECHINACEA, UNSPECIFIED; JUNIPERUS COMMUNIS FRUIT; LACHESIS MUTA VENOM; LYTTA VESICATORIA; MERCURY; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; SAMBUCUS NIGRA FLOWERING TOP; SODIUM CARBONATE; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; URTICA URENS; VIPERA BERUS VENOM 15; 8; 15; 15; 15; 15; 15; 15; 8; 15; 15; 15; 15; 35; 15; 15; 15; 15; 8; 15; 8; 15; 15; 8; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 55714-4544_d72ad106-b759-0526-9538-cc6de63cc17d 55714-4544 HUMAN PRESCRIPTION DRUG Lymphatic Drainer Asterias rubens, Aur. met.,Belladonna, Benzoicum acidum, Berber. vulg., Bryonia, Calc. carb., Cantharis, Ceanothus, Chelidonium majus Chionanthus virginica, Cinchona, Dioscorea ,Iris versicolor, Nat. carb., Nux vom., Ptelea, Carduus mar., Echinacea, Solidago, Taraxacum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ASTERIAS RUBENS; ATROPA BELLADONNA; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; ECHINACEA, UNSPECIFIED; GOLD; IRIS VERSICOLOR ROOT; LYTTA VESICATORIA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; SODIUM CARBONATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 3; 15; 3; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4545_2a41ae1d-563d-5e45-2ae4-28b59421ca59 55714-4545 HUMAN PRESCRIPTION DRUG Lymphatic Drainer Asterias rubens, Aur. met.,Belladonna, Benzoicum acidum, Berber. vulg., Bryonia, Calc. carb., Cantharis, Ceanothus, Chelidonium majus Chionanthus virginica, Cinchona, Dioscorea ,Iris versicolor, Nat. carb., Nux vom., Ptelea, Carduus mar., Echinacea, Solidago, Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ASTERIAS RUBENS; ATROPA BELLADONNA; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; ECHINACEA, UNSPECIFIED; GOLD; IRIS VERSICOLOR ROOT; LYTTA VESICATORIA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; SODIUM CARBONATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 3; 15; 3; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4548_7d1dc879-32aa-c0c9-8a70-d10ea68fb38a 55714-4548 HUMAN PRESCRIPTION DRUG intestinal Bacteria Pyrogenium, Arsenicum alb.,Baptisia, Bryonia, Cinchona, Collinsonia, Iodium, Iris versicolor, Lachesis, Lycopodium, Nat. carb.,Nat.mur.,Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Rhus toxicodendron, Dioscorea, Echinacea, Urtica ur. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; DIOSCOREA VILLOSA TUBER; ECHINACEA, UNSPECIFIED; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; RANCID BEEF; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 15; 15; 15; 15; 15; 3; 3; 15; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4549_7eb4d14a-c125-84bd-b723-39c208a83882 55714-4549 HUMAN PRESCRIPTION DRUG intestinal Bacteria Pyrogenium, Arsenicum alb.,Baptisia, Bryonia, Cinchona, Collinsonia, Iodium, Iris versicolor, Lachesis, Lycopodium, Nat. carb.,Nat.mur.,Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Rhus toxicodendron, Dioscorea, Echinacea, Urtica ur. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; DIOSCOREA VILLOSA TUBER; ECHINACEA, UNSPECIFIED; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; RANCID BEEF; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 15; 15; 15; 15; 15; 3; 3; 15; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4550_40791ac5-19ec-e2fd-1913-4daab23547d0 55714-4550 HUMAN PRESCRIPTION DRUG Bacterial Infection Anthracinum , Pyrogenium, Aconitum nap., Arnica, Arsenicum alb., Baptisia, Bryonia, Hydrastis, Iodium, Lachesis, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron , Echinacea , Iris versicolor, Urtica ur. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; PHOSPHORUS; PULSATILLA VULGARIS; RANCID BEEF; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 15; 15; 15; 30; 15; 15; 3; 15; 15; 3; 15; 15; 15; 30; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4551_ddb7e68c-6211-5da1-f0df-0f0841e26f37 55714-4551 HUMAN PRESCRIPTION DRUG Bacterial Infection Anthracinum , Pyrogenium, Aconitum nap., Arnica, Arsenicum alb., Baptisia, Bryonia, Hydrastis, Iodium, Lachesis, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron , Echinacea , Iris versicolor, Urtica ur. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; PHOSPHORUS; PULSATILLA VULGARIS; RANCID BEEF; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 15; 15; 15; 30; 15; 15; 3; 15; 15; 3; 15; 15; 15; 30; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4552_b3212ca5-a35b-8a2a-388f-cbf14ecf53a2 55714-4552 HUMAN PRESCRIPTION DRUG Exhaustion Chronic Fatigue Aconitum nap., Adrenalinum, Aralia quinquefolia, Arnica, Arsenicum alb., Baptisia, Bryonia, Cantharis, Chelidonium majus, Cinchona, Iodium, Kali carb., Kali iod.,Lachesis,Lycopodium, Lycopus virginicus, Nat. mur., Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabal, Thyroidinum, Echinacea, Gingko, Phytolacca, alcohol LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GINKGO; GINKGO; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; LYTTA VESICATORIA; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; SAW PALMETTO; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 20; 20; 20; 20; 20; 20; 20; 20; 3; 8; 20; 3; 8; 20; 20; 20; 20; 20; 20; 3; 8; 20; 20; 20; 20; 20; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55714-4553_3b0bdf85-f599-4bac-a98e-f4cb2b0bcfa7 55714-4553 HUMAN PRESCRIPTION DRUG Exhaustion - Chronic Fatigue Aconitum nap., Adrenalinum, Aralia quinquefolia, Arnica, Arsenicum alb., Baptisia, Bryonia, Cantharis, Chelidonium majus, Cinchona, Iodium, Kali carb., Kali iod., Lachesis, Lycopodium, Lycopus virginicus, Nat. mur., Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabal, Thyroidinum, Echinacea, Gingko, Phytolacca PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GINKGO; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; LYTTA VESICATORIA; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; SAW PALMETTO; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 8; 20; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 20; 20; 20; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55714-4554_d3741ef3-2b18-2815-94a8-853f7aa3a8e6 55714-4554 HUMAN PRESCRIPTION DRUG Viral Infection Influenza A Virus, Influenza B Virus, Morbillinum, Aconitum nap., Antimon. tart., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Gaultheria procumbens, Hepar sulph. calc., Iodium, Lachesis, Lycopodium, Merc.viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Trifolium pratense, Echinacea, Hydrastis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; GAULTHERIA PROCUMBENS TOP; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MATRICARIA RECUTITA; MEASLES VIRUS; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 3; 30; 30; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-4555_1a9d218a-6f2e-feeb-fa98-dfdd0fae9037 55714-4555 HUMAN PRESCRIPTION DRUG Viral Infection Influenza A Virus, Influenza B Virus, Morbillinum, Aconitum nap., Antimon. tart., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Gaultheria procumbens, Hepar sulph. calc., Iodium, Lachesis, Lycopodium, Merc.viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Trifolium pratense, Echinacea, Hydrastis PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; GAULTHERIA PROCUMBENS TOP; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MATRICARIA RECUTITA; MEASLES VIRUS; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 3; 30; 30; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-4560_494dd01a-866d-06b3-e868-52b240e51a62 55714-4560 HUMAN PRESCRIPTION DRUG Heavy Metal Amalga Detox Allium sat, Alumin met, Arg. met., Aur. met., Baryta carb., Beryllium, Bismuthum met, Cadmium met,Calc. fluor., Carbo veg., Chelidonium maj, Cinchona, Cobaltum met., Cuprum met., Glycyrrhiza, Hydrofluoricum ac, Iris ver, Mang met, Merc. viv., Niccolum met, Osmium met, Platinum met., Plumb. met., Stannum met., Strontium carb., Thallium met, Titanium met, Carduus mar., Iris versicolor, Tarax, Carduus mar. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ALUMINUM; BARIUM CARBONATE; BERYLLIUM; BISMUTH; CADMIUM; CALCIUM FLUORIDE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; COBALT; COPPER; GARLIC; GLYCYRRHIZA GLABRA; GOLD; HYDROFLUORIC ACID; IRIS VERSICOLOR ROOT; IRIS VERSICOLOR ROOT; IRIS VERSICOLOR ROOT; LEAD; MANGANESE; MERCURY; NICKEL; OSMIUM; PLATINUM; SILVER; SILYBUM MARIANUM SEED; SILYBUM MARIANUM SEED; STRONTIUM CARBONATE; TARAXACUM OFFICINALE; TARAXACUM OFFICINALE; THALLIUM; TIN; TITANIUM 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 3; 8; 20; 20; 20; 20; 20; 20; 20; 3; 8; 20; 3; 8; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 55714-4561_5ae84d1d-d38f-4150-5601-8165ff09bd83 55714-4561 HUMAN PRESCRIPTION DRUG Heavy Metal - Amalga Detox Allium sat., Alumin met., Arg. met., Aur. met., Baryta carb., Beryllium, Bismuthum met., Cadmium met., Calc. fluor., Carbo veg., Chelidonium maj., Cinchona, Cobaltum met., Cuprum met., Glycyrrhiza, Hydrofluoricum ac., Iris versicolor, Mang met., Merc. viv., Niccolum met., Osmium met., Platinum met., Plumb. met., Stannum met., Strontium carb., Thallium met., Titanium met., Carduus mar., Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ALUMINUM; BARIUM CARBONATE; BERYLLIUM; BISMUTH; CADMIUM; CALCIUM FLUORIDE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; COBALT; COPPER; GARLIC; GLYCYRRHIZA GLABRA; GOLD; HYDROFLUORIC ACID; IRIS VERSICOLOR ROOT; LEAD; MANGANESE; MERCURY; NICKEL; OSMIUM; PLATINUM; SILVER; SILYBUM MARIANUM SEED; STRONTIUM CARBONATE; TARAXACUM OFFICINALE; THALLIUM; TIN; TITANIUM 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20; 8; 20; 20; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 55714-4564_221460f9-ebbb-19cb-724f-b1fa30ff7fd9 55714-4564 HUMAN PRESCRIPTION DRUG Connective Tissue Arsenicum alb., Baptisia, Berber. aqui., Calc. fluor., Capsicum, Cinchona, Iodium, Kali carb., Lachesis, Mag. carb., Merc.viv., Nat. carb., Nat. mur., Natrum sulphuricum, Phosphorus, Phytolacca, Secale, Thymus serpyllum, Thuja occ., Thyroidinum, Verbascum, Carduus mar., Echinacea, Solidago, Taraxacum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; CALCIUM FLUORIDE; CAPSICUM; CINCHONA BARK; CLAVICEPS PURPUREA SCLEROTIUM; ECHINACEA, UNSPECIFIED; IODINE; LACHESIS MUTA VENOM; MAGNESIUM CARBONATE; MAHONIA AQUIFOLIUM ROOT BARK; MERCURY; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; SILYBUM MARIANUM SEED; SODIUM CARBONATE; SODIUM CHLORIDE; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; THYMUS SERPYLLUM; THYROID, UNSPECIFIED; VERBASCUM THAPSUS 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 3; 3; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 55714-4565_a54f462f-ee7c-c126-1846-473e96098cef 55714-4565 HUMAN PRESCRIPTION DRUG Connective Tissue Arsenicum alb., Baptisia, Berber. aqui., Calc. fluor., Capsicum, Cinchona, Iodium, Kali carb., Lachesis, Mag. carb., Merc.viv., Nat. carb., Nat. mur., Natrum sulphuricum, Phosphorus, Phytolacca, Secale, Thymus serpyllum, Thuja occ., Thyroidinum, Verbascum, Carduus mar., Echinacea, Solidago, Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; CALCIUM FLUORIDE; CAPSICUM; CINCHONA BARK; CLAVICEPS PURPUREA SCLEROTIUM; ECHINACEA, UNSPECIFIED; IODINE; LACHESIS MUTA VENOM; MAGNESIUM CARBONATE; MAHONIA AQUIFOLIUM ROOT BARK; MERCURY; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; SILYBUM MARIANUM SEED; SODIUM CARBONATE; SODIUM CHLORIDE; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; THYMUS SERPYLLUM; THYROID, UNSPECIFIED; VERBASCUM THAPSUS 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 3; 3; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 55714-4566_e536f5a7-68a7-1dfd-3a6e-ffd43eb0dbd8 55714-4566 HUMAN PRESCRIPTION DRUG Depression - Mood Support Angelica sinensis, radix, Aralia quinquefolia, Arg. nit., Arsenicum alb., Berber. aqui., Capsicum, Cinchona, Digitalis, Gelsemium, Hypericum, Ignatia, Iodium, Kali brom., Kali carb., Mag. phos., Nat. carb., Nat. mur., Phosphorus, Salix nigra, Sanguinaria, Sepia, Stramonium, Echinacea, Ginkgo LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMERICAN GINSENG; ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; CAPSICUM; CINCHONA OFFICINALIS BARK; DATURA STRAMONIUM; DIGITALIS; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; HYPERICUM PERFORATUM; IODINE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MAHONIA AQUIFOLIUM ROOT BARK; PHOSPHORUS; POTASSIUM BROMIDE; POTASSIUM CARBONATE; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 15; 15; 15; 15; 15; 15; 15; 8; 15; 8; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 55714-4567_c72bc0a6-d529-5efc-1a5e-137330200619 55714-4567 HUMAN PRESCRIPTION DRUG Depression - Mood Support Angelica sinensis, radix, Aralia quinquefolia, Arg. nit., Arsenicum alb., Berber. aqui., Capsicum, Cinchona, Digitalis, Gelsemium, Hypericum, Ignatia, Iodium, Kali brom., Kali carb., Mag. phos., Nat. carb., Nat. mur., Phosphorus, Salix nigra, Sanguinaria, Sepia, Stramonium, Echinacea, Ginkgo PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMERICAN GINSENG; ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; CAPSICUM; CINCHONA OFFICINALIS BARK; DATURA STRAMONIUM; DIGITALIS; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; HYPERICUM PERFORATUM; IODINE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MAHONIA AQUIFOLIUM ROOT BARK; PHOSPHORUS; POTASSIUM BROMIDE; POTASSIUM CARBONATE; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 15; 15; 15; 15; 15; 15; 15; 8; 15; 8; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 55714-4568_de6fec33-9c43-d6e0-d785-aa432be93ea9 55714-4568 HUMAN PRESCRIPTION DRUG Food Allergy - Additive E102 Tartrazine, E104 Quinoline yellow, E110 Sunset/Orange yellow, E122 Carmoisine, E123 Armaranth, E124 Cochineal red A, E127 Erythrosine, D128 Red 2G, E 132 Indigotine, E141 Copper/Chlorophyll Complex, E142 Green S, E211 Sodium benzoate, E212 Potassium benzoate, E216 Propyl P-hydroxybenzoate, E223 Sodium metabisulphate, E231 Orthophenylphenol, E250 Sodium nitrate, E300 Ascorbic acid, E399 Sodium mono/bi/triphosphate, E951 Aspartame, Monosodium glutamate, Beef, Pork, Lamb, Chicken, Turkey, Clam LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. 2-PHENYLPHENOL; ABRUS PRECATORIUS SEED; ACID GREEN 50; ACID RED 1; ACONITUM NAPELLUS; ALLYLTHIOUREA; ALPINE STRAWBERRY; AMANITA MUSCARIA FRUITING BODY; AMARANTH; ANACARDIUM OCCIDENTALE FRUIT; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ASCORBIC ACID; ASPARTAME; BAPTISIA TINCTORIA ROOT; BEEF; BLACK MUSTARD SEED; BRAZIL NUT; CAFFEINE; CAPSICUM; CARMOISINE; CHICKEN; CINCHONA OFFICINALIS BARK; CINNAMON; COD, UNSPECIFIED; CRAB LEG, UNSPECIFIED; CYNARA SCOLYMUS LEAF; D&C YELLOW NO. 10; EGG; FD&C BLUE NO. 2; FD&C RED NO. 3; FD&C YELLOW NO. 5; FD&C YELLOW NO. 6; GARLIC; GELSEMIUM SEMPERVIRENS ROOT; GINGER; GLYCYRRHIZA GLABRA; HAZELNUT, UNSPECIFIED; HERRING, UNSPECIFIED; HISTAMINE DIHYDROCHLORIDE; IPECAC; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LACTOSE; LAMB; LEDUM PALUSTRE TWIG; LYCOPERDON UTRIFORME FRUITING BODY; LYCOPODIUM CLAVATUM SPORE; MENTHA PIPERITA; MONOSODIUM GLUTAMATE; NUTMEG; ONION; OYSTER, UNSPECIFIED; PEANUT; PHOSPHORUS; PODOPHYLLUM; PONCEAU 4R; PORK; POTASSIUM BENZOATE; PROPYLPARABEN; PULSATILLA VULGARIS; QUAHOG, UNSPECIFIED; SACCHARIN; SACCHAROMYCES CEREVISIAE; SALMON, UNSPECIFIED; SCALLOP, UNSPECIFIED; SEPIA OFFICINALIS JUICE; SHRIMP, UNSPECIFIED; SODIUM BENZOATE; SODIUM CHLORIDE; SODIUM COPPER CHLOROPHYLLIN; SODIUM DITHIONATE; SODIUM NITRITE; SODIUM TRIPOLYPHOSPHATE; SOLANUM LYCOPERSICUM; SOLANUM NIGRUM WHOLE; SOLANUM TUBEROSUM; SOLIDAGO VIRGAUREA FLOWERING TOP; SUCROSE; SULFUR; TOXICODENDRON PUBESCENS LEAF; TROUT, UNSPECIFIED; TUNA, UNSPECIFIED; TURKEY; URTICA URENS; USTILAGO MAYDIS 60; 15; 60; 60; 10; 15; 15; 15; 60; 15; 10; 10; 60; 60; 10; 60; 15; 15; 15; 15; 60; 60; 10; 15; 15; 60; 15; 60; 60; 60; 60; 60; 60; 15; 10; 15; 15; 15; 15; 15; 10; 3; 10; 15; 60; 10; 15; 10; 15; 60; 15; 15; 60; 15; 10; 10; 60; 60; 60; 60; 10; 60; 15; 15; 15; 60; 10; 60; 60; 10; 60; 60; 60; 60; 15; 15; 15; 3; 15; 10; 10; 15; 15; 60; 10; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC] 55714-4569_9613f5be-7d54-783a-e97a-279bde8c1cb9 55714-4569 HUMAN PRESCRIPTION DRUG Food Allergy - Additive E102 Tartrazine, E104 Quinoline yellow, E110 Sunset/Orange yellow, E122 Carmoisine, E123 Armaranth, E124 Cochineal red A, E127 Erythrosine, D128 Red 2G, E 132 Indigotine, E141 Copper/Chlorophyll Complex, E142 Green S, E211 Sodium benzoate, E212 Potassium benzoate, E216 Propyl P-hydroxybenzoate, E223 Sodium metabisulphate, E231 Orthophenylphenol, E250 Sodium nitrate, E300 Ascorbic acid, E399 Sodium mono/bi/triphosphate, E951 Aspartame, Monosodium glutamate, Beef, Pork, Lamb, Chicken, Turkey, Clam PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. 2-PHENYLPHENOL; ABRUS PRECATORIUS SEED; ACID GREEN 50; ACID RED 1; ACONITUM NAPELLUS; ALLYLTHIOUREA; ALPINE STRAWBERRY; AMANITA MUSCARIA FRUITING BODY; AMARANTH; ANACARDIUM OCCIDENTALE FRUIT; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ASCORBIC ACID; ASPARTAME; BAPTISIA TINCTORIA ROOT; BEEF; BLACK MUSTARD SEED; BRAZIL NUT; CAFFEINE; CAPSICUM; CARMOISINE; CHICKEN; CINCHONA OFFICINALIS BARK; CINNAMON; COD, UNSPECIFIED; CRAB LEG, UNSPECIFIED; CYNARA SCOLYMUS LEAF; D&C YELLOW NO. 10; EGG; FD&C BLUE NO. 2; FD&C RED NO. 3; FD&C YELLOW NO. 5; FD&C YELLOW NO. 6; GARLIC; GELSEMIUM SEMPERVIRENS ROOT; GINGER; GLYCYRRHIZA GLABRA; HAZELNUT, UNSPECIFIED; HERRING, UNSPECIFIED; HISTAMINE DIHYDROCHLORIDE; IPECAC; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LACTOSE; LAMB; LEDUM PALUSTRE TWIG; LYCOPERDON UTRIFORME FRUITING BODY; LYCOPODIUM CLAVATUM SPORE; MENTHA PIPERITA; MONOSODIUM GLUTAMATE; NUTMEG; ONION; OYSTER, UNSPECIFIED; PEANUT; PHOSPHORUS; PODOPHYLLUM; PONCEAU 4R; PORK; POTASSIUM BENZOATE; PROPYLPARABEN; PULSATILLA VULGARIS; QUAHOG, UNSPECIFIED; SACCHARIN; SACCHAROMYCES CEREVISIAE; SALMON, UNSPECIFIED; SCALLOP, UNSPECIFIED; SEPIA OFFICINALIS JUICE; SHRIMP, UNSPECIFIED; SODIUM BENZOATE; SODIUM CHLORIDE; SODIUM COPPER CHLOROPHYLLIN; SODIUM DITHIONATE; SODIUM NITRITE; SODIUM TRIPOLYPHOSPHATE; SOLANUM LYCOPERSICUM; SOLANUM NIGRUM WHOLE; SOLANUM TUBEROSUM; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; TOXICODENDRON PUBESCENS LEAF; TROUT, UNSPECIFIED; TUNA, UNSPECIFIED; TURKEY; URTICA URENS; USTILAGO MAYDIS 60; 15; 60; 60; 10; 15; 15; 15; 60; 15; 10; 10; 60; 60; 10; 60; 15; 15; 15; 15; 60; 60; 10; 15; 15; 60; 15; 60; 60; 60; 60; 60; 60; 15; 10; 15; 15; 15; 15; 15; 10; 3; 10; 15; 60; 10; 15; 10; 15; 60; 15; 15; 60; 15; 10; 10; 60; 60; 60; 60; 10; 60; 15; 15; 15; 60; 10; 60; 60; 10; 60; 60; 60; 60; 15; 15; 15; 3; 10; 10; 15; 15; 60; 10; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 55714-4570_1f3473d1-e91d-5370-3a31-5319b94bc669 55714-4570 HUMAN PRESCRIPTION DRUG Pollen Weeds Xerophyllum asphodeloides, Adrenalinum, Alfalfa, Aletris farinosa, Artemisia vulgaris, Bellis perennis, Dysphania ambrosioides, Lycopus virginicus, Phytolacca american root, Populus tremuloides, Ptelea trifoliata, Sambusus nigra, Trillium erectum root, Elymus repens root, Urtica urens, Wyethia helenioides, Yucca filamentosa, Avena sativa pollen, Cynosurus cristatus pollen. Echinochloa crus-galli pollen, Poa pratensis pollen, Anthoxanthum odoratum pollen, Agrostis gigantea pollen, Bromus secalinus pollen LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AGROSTIS GIGANTEA POLLEN; ALETRIS FARINOSA ROOT; ALFALFA; ALOPECURUS PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; AVENA SATIVA POLLEN; BAPTISIA TINCTORIA ROOT; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; BETULA PENDULA POLLEN; BROMUS SECALINUS POLLEN; BRYONIA ALBA ROOT; CALLUNA VULGARIS POLLEN; CHELIDONIUM MAJUS; CORYLUS AMERICANA POLLEN; CRATAEGUS MONOGYNA POLLEN; CYNOSURUS CRISTATUS POLLEN; CYTISUS SCOPARIUS POLLEN; DIANTHUS CARYOPHYLLUS FLOWER; DIOSCOREA VILLOSA TUBER; DYSPHANIA AMBROSIOIDES; ECHINOCHLOA CRUS-GALLI POLLEN; ELYMUS REPENS ROOT; EPINEPHRINE; EUPHRASIA STRICTA; FAGUS SYLVATICA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS EXCELSIOR POLLEN; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; HOLCUS LANATUS POLLEN; JUNIPERUS VIRGINIANA TWIG; LACHESIS MUTA VENOM; LILIUM CANDIDUM FLOWER; LOLIUM PERENNE POLLEN; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; NARCISSUS PSEUDONARCISSUS; ONION; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PLATANUS ORIENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS BALSAMIFERA LEAF BUD; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PRIMULA VULGARIS; PTELEA TRIFOLIATA BARK; PULSATILLA VULGARIS; QUERCUS ALBA POLLEN; ROSA CANINA FLOWER; SALIX ALBA POLLEN; SAMBUCUS NIGRA FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; TARAXACUM OFFICINALE; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER; TRILLIUM ERECTUM ROOT; ULEX EUROPAEUS FLOWER; ULMUS GLABRA POLLEN; URTICA URENS; USTILAGO MAYDIS; WYETHIA HELENIOIDES ROOT; XEROPHYLLUM ASPHODELOIDES; YUCCA FILAMENTOSA 20; 20; 20; 20; 20; 15; 15; 20; 20; 15; 20; 15; 20; 20; 15; 20; 15; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 15; 20; 20; 20; 15; 8; 8; 20; 20; 20; 15; 20; 20; 15; 20; 20; 15; 20; 20; 20; 20; 20; 20; 20; 20; 15; 15; 20; 20; 15; 20; 20; 20; 20; 15; 8; 20; 20; 20; 20; 20; 20; 20; 20; 35; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] 55714-4571_c2e35333-a63f-486a-5b66-04b39719b7e6 55714-4571 HUMAN PRESCRIPTION DRUG Pollen - Weeds Xerophyllum asphodeloides, Adrenalinum, Alfalfa, Aletris farinosa, Artemisia vulgaris, Bellis perennis, Dysphania ambrosioides, Lycopus virginicus, Phytolacca american root, Populus tremuloides, Ptelea trifoliata, Sambusus nigra, Trillium erectum root, Elymus repens root, Urtica urens, Wyethia helenioides, Yucca filamentosa, Avena sativa pollen, Cynosurus cristatus pollen. Echinochloa crus-galli pollen, Poa pratensis pollen, Anthoxanthum odoratum pollen, Agrostis gigantea pollen, Bromus secalinus pollen PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AGROSTIS GIGANTEA POLLEN; ALETRIS FARINOSA ROOT; ALFALFA; ALOPECURUS PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; AVENA SATIVA POLLEN; BAPTISIA TINCTORIA ROOT; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; BETULA PENDULA POLLEN; BROMUS SECALINUS POLLEN; BRYONIA ALBA ROOT; CALLUNA VULGARIS POLLEN; CHELIDONIUM MAJUS; CORYLUS AMERICANA POLLEN; CRATAEGUS MONOGYNA POLLEN; CYNOSURUS CRISTATUS POLLEN; CYTISUS SCOPARIUS POLLEN; DIANTHUS CARYOPHYLLUS FLOWER; DIOSCOREA VILLOSA TUBER; DYSPHANIA AMBROSIOIDES; ECHINOCHLOA CRUS-GALLI POLLEN; ELYMUS REPENS ROOT; EPINEPHRINE; EUPHRASIA STRICTA; FAGUS SYLVATICA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS EXCELSIOR POLLEN; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; HOLCUS LANATUS POLLEN; JUNIPERUS VIRGINIANA TWIG; LACHESIS MUTA VENOM; LILIUM CANDIDUM FLOWER; LOLIUM PERENNE POLLEN; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; NARCISSUS PSEUDONARCISSUS; ONION; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PLATANUS ORIENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS BALSAMIFERA LEAF BUD; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PRIMULA VULGARIS; PTELEA TRIFOLIATA BARK; PULSATILLA VULGARIS; QUERCUS ALBA POLLEN; ROSA CANINA FLOWER; SALIX ALBA POLLEN; SAMBUCUS NIGRA FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; TARAXACUM OFFICINALE; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER; TRILLIUM ERECTUM ROOT; ULEX EUROPAEUS FLOWER; ULMUS GLABRA POLLEN; URTICA URENS; USTILAGO MAYDIS; WYETHIA HELENIOIDES ROOT; XEROPHYLLUM ASPHODELOIDES; YUCCA FILAMENTOSA 20; 20; 20; 20; 20; 15; 15; 20; 20; 15; 20; 15; 20; 20; 15; 20; 15; 20; 20; 20; 20; 20; 8; 20; 20; 20; 20; 15; 20; 20; 20; 15; 8; 8; 20; 20; 20; 15; 20; 20; 15; 20; 20; 15; 20; 20; 20; 20; 20; 20; 20; 20; 15; 15; 20; 20; 15; 20; 20; 20; 20; 15; 8; 20; 20; 20; 20; 20; 20; 20; 20; 35; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] 55714-4572_d91ed19d-70e9-8c6c-75de-21bacde569a2 55714-4572 HUMAN PRESCRIPTION DRUG Dairy - Grain - Nightshades Cow milk, Skim milk, Cow milk fat, Casein lactococcus lactis cultured aged, Casein lactococcus lactis cultured penicilium roqueforti cultured aged, Casein lctococcus lactis cultured penicillium camemberti cultured aged, Barley, Corn, Wheat gluten, Oat, White rice, Rye, Wheat, Lycopersicum esculentum, Sac. lac., Solanum tuberosum,Torula cerevisiae, Ustilago maidis, Antimon. crud., Arg.nit., Arsenicum alb., Baptisia, Bryonia, Carduus benedictus, Cinchona, Gelsemium, Ipecac., Lachesis, Lycopodium LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BARLEY; BRYONIA ALBA ROOT; CAPSICUM; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CENTAUREA BENEDICTA; CINCHONA OFFICINALIS BARK; CORN; COW MILK; COW MILK FAT; DATURA STRAMONIUM; ELYMUS REPENS ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; IPECAC; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LACTOSE; LYCOPODIUM CLAVATUM SPORE; OAT; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; RYE; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SKIM MILK; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP; SOLANUM LYCOPERSICUM; SOLANUM NIGRUM WHOLE; SOLANUM TUBEROSUM; SOLIDAGO VIRGAUREA FLOWERING TOP; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; USTILAGO MAYDIS; VERBASCUM THAPSUS; WHEAT; WHEAT GLUTEN; WHITE RICE 10; 10; 15; 10; 60; 10; 15; 60; 60; 60; 10; 10; 60; 60; 60; 15; 10; 10; 15; 10; 3; 10; 15; 10; 60; 10; 10; 10; 60; 15; 10; 10; 60; 10; 15; 15; 15; 15; 3; 15; 10; 15; 10; 60; 60; 60 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 55714-4573_7f1b97d3-dd09-3acc-51fc-60388e71dd1d 55714-4573 HUMAN PRESCRIPTION DRUG Dairy - Grain - Nightshades Cow milk, Skim milk, Cow milk fat, Casein lactococcus lactis cultured aged, Casein lactococcus lactis cultured penicilium roqueforti cultured aged, Casein lctococcus lactis cultured penicillium camemberti cultured aged, Barley, Corn, Wheat gluten, Oat, White rice, Rye, Wheat, Lycopersicum esculentum, Sac. lac., Solanum tuberosum,Torula cerevisiae, Ustilago maidis, Antimon. crud., Arg.nit., Arsenicum alb., Baptisia, Bryonia, Carduus benedictus, Cinchona, Gelsemium, Ipecac., Lachesis, Lycopodium PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BARLEY; BRYONIA ALBA ROOT; CAPSICUM; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CENTAUREA BENEDICTA; CINCHONA OFFICINALIS BARK; CORN; COW MILK; COW MILK FAT; DATURA STRAMONIUM; ELYMUS REPENS ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; IPECAC; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LACTOSE; LYCOPODIUM CLAVATUM SPORE; OAT; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; RYE; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SKIM MILK; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP; SOLANUM LYCOPERSICUM; SOLANUM NIGRUM WHOLE; SOLANUM TUBEROSUM; SOLIDAGO VIRGAUREA FLOWERING TOP; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; USTILAGO MAYDIS; VERBASCUM THAPSUS; WHEAT; WHEAT GLUTEN; WHITE RICE 10; 10; 15; 10; 60; 10; 15; 60; 60; 60; 10; 10; 60; 60; 60; 15; 10; 10; 15; 10; 3; 10; 15; 10; 60; 10; 10; 10; 60; 15; 10; 10; 60; 10; 15; 15; 15; 15; 3; 15; 10; 15; 10; 60; 60; 60 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 55714-4574_066c311c-9bba-f0c1-3005-7e1e2d4d2f14 55714-4574 HUMAN PRESCRIPTION DRUG Dust - Mold - Dander Felis catus skin, Canis lupus familiaris skin, Ortcyolagus cuniculus skin, Equus caballus skin, Serinus canaria feather, Gallus gallus feather, Anas platyrhynchos feather, Anser anser feather, Melopsittacus undulatus feather, Phasianus colchicus feather, Meleagris gallopavo feather, Felis catus hair, Human dander, Canis lupus familiaris hair, Equus caballus hair, Oryctolagus cuniculus hair, Human hair, Human skin, Sheep wool, Bos taurus hair, Capra hircus hair, Cavia porcellus hair LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; BAPTISIA TINCTORIA ROOT; BLATTA ORIENTALIS; BOS TAURUS HAIR; BROMINE; BRYONIA ALBA ROOT; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CANIS LUPUS FAMILIARIS SKIN; CAPRA HIRCUS HAIR; CAVIA PORCELLUS HAIR; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CLADOSPORIUM HERBARUM; EQUUS CABALLUS HAIR; EQUUS CABALLUS SKIN; FELIS CATUS HAIR; FELIS CATUS SKIN; GALLUS GALLUS FEATHER; HISTAMINE DIHYDROCHLORIDE; HOUSE DUST; HUMAN DANDER; HUMAN HAIR; HUMAN SKIN; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MELEAGRIS GALLOPAVO FEATHER; MELOPSITTACUS UNDULATUS FEATHER; MESOCRICETUS AURATUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; ORYCTOLAGUS CUNICULUS SKIN; PHASIANUS COLCHICUS FEATHER; PODOPHYLLUM; SACCHAROMYCES CEREVISIAE; SERINUS CANARIA FEATHER; SHEEP WOOL; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; USTILAGO MAYDIS; WHEAT GLUTEN 65; 65; 15; 15; 15; 20; 15; 15; 65; 15; 15; 20; 65; 65; 65; 65; 15; 15; 15; 20; 65; 65; 65; 65; 65; 20; 20; 65; 65; 65; 15; 8; 15; 65; 65; 65; 65; 65; 65; 15; 20; 65; 65; 15; 8; 15; 15; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC] 55714-4575_fa83de7c-ae1a-ec32-e7c2-9acdde70ac7e 55714-4575 HUMAN PRESCRIPTION DRUG Dust - Mold - Dander Felis catus skin, Canis lupus familiaris skin, Ortcyolagus cuniculus skin, Equus caballus skin, Serinus canaria feather, Gallus gallus feather, Anas platyrhynchos feather, Anser anser feather, Melopsittacus undulatus feather, Phasianus colchicus feather, Meleagris gallopavo feather, Felis catus hair, Human dander, Canis lupus familiaris hair, Equus caballus hair, Oryctolagus cuniculus hair, Human hair, Human skin, Sheep wool, Bos taurus hair, Capra hircus hair, Cavia porcellus hair PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; BAPTISIA TINCTORIA ROOT; BLATTA ORIENTALIS; BOS TAURUS HAIR; BROMINE; BRYONIA ALBA ROOT; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS HAIR; CANIS LUPUS FAMILIARIS SKIN; CAPRA HIRCUS HAIR; CAVIA PORCELLUS HAIR; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CLADOSPORIUM HERBARUM; EQUUS CABALLUS HAIR; EQUUS CABALLUS SKIN; FELIS CATUS HAIR; FELIS CATUS SKIN; GALLUS GALLUS FEATHER; HISTAMINE DIHYDROCHLORIDE; HOUSE DUST; HUMAN DANDER; HUMAN HAIR; HUMAN SKIN; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MELEAGRIS GALLOPAVO FEATHER; MELOPSITTACUS UNDULATUS FEATHER; MESOCRICETUS AURATUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; ORYCTOLAGUS CUNICULUS SKIN; PHASIANUS COLCHICUS FEATHER; PODOPHYLLUM; SACCHAROMYCES CEREVISIAE; SERINUS CANARIA FEATHER; SHEEP WOOL; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; USTILAGO MAYDIS; WHEAT GLUTEN 65; 65; 15; 15; 15; 20; 15; 15; 65; 15; 15; 20; 65; 65; 65; 65; 15; 15; 15; 20; 65; 65; 65; 65; 65; 20; 20; 65; 65; 65; 15; 8; 15; 65; 65; 65; 65; 65; 65; 15; 20; 65; 65; 15; 8; 15; 15; 20; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC] 55714-4580_de802f71-3f9a-deab-91dc-a5d2709721b7 55714-4580 HUMAN PRESCRIPTION DRUG Glaucoma Aconitum nap., Aur. met., Belladonna, Causticum, Cinchona, Colchicum, Euphrasia, Gelsemium, Nux vom., Osmium metallicum, Phosphorus, Physostigma, Rhus toxicodendron, Spigelia anth. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; GOLD; OSMIUM; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4581_f9b9f588-fd69-3ec2-1fd1-991ce8039491 55714-4581 HUMAN PRESCRIPTION DRUG Glaucoma Aconitum nap., Aur. met., Belladonna, Causticum, Cinchona, Colchicum, Euphrasia, Gelsemium, Nux vom., Osmium metallicum, Phosphorus, Physostigma, Rhus toxicodendron, Spigelia anth. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; GOLD; OSMIUM; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4584_e8b54edb-86d5-b2a1-0884-0f4d99e7c270 55714-4584 HUMAN PRESCRIPTION DRUG Tinnitus Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac, Tabacum, Thiosinaminum, Viola odorata LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALLYLTHIOUREA; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; DYSPHANIA AMBROSIOIDES; GOLDENSEAL; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; QUININE SULFATE; SALICYLIC ACID; TOBACCO LEAF; VIOLA ODORATA 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Antimalarial [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 55714-4585_2c8847e3-e129-6b7d-ff3e-832fd636f527 55714-4585 HUMAN PRESCRIPTION DRUG Tinnitus Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac, Tabacum, Thiosinaminum, Viola odorata PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALLYLTHIOUREA; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; DYSPHANIA AMBROSIOIDES; GOLDENSEAL; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; PHOSPHORUS; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; QUININE SULFATE; SALICYLIC ACID; TOBACCO LEAF; VIOLA ODORATA 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Antimalarial [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 55714-4586_87d9cff8-cdcb-9e68-c0c7-cdc39badb098 55714-4586 HUMAN PRESCRIPTION DRUG Thyroid Assist Adrenalinum, Thyroidinum, Aloe, Calc. carb., Chelidonium majus, Conium, Graphites, Iodium, Lachesis, Lycopodium, Lycopus virginicus, Phytolacca, Rhus toxicodendron, Silicea, Spongia, Echinacea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GRAPHITE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 8; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 20; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55714-4587_f7163df4-9519-d291-4475-b0189d1adb38 55714-4587 HUMAN PRESCRIPTION DRUG Thyroid Assist Adrenalinum, Thyroidinum, Aloe, Calc. carb., Chelidonium majus, Conium, Graphites, Iodium, Lachesis, Lycopodium, Lycopus virginicus, Phytolacca, Rhus toxicodendron, Silicea, Spongia, Echinacea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GRAPHITE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 8; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 20; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 55714-4588_000950e6-1774-b77d-e8c2-bd12a396e544 55714-4588 HUMAN PRESCRIPTION DRUG Cataracts Arsenicum alb., Bryonia, Calc. fluor., Calendula, Causticum, Conium , Euphrasia, Hydrofluoricum acidum , Iodium, Ledum, Naphthalinum, Nat. mur., Nux vom., Phosphorus, Pulsatilla, Sepia, Silicea, Tellurium metallicum, Thiosinaminum, Zinc. met., Euphrasia LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALLYLTHIOUREA; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; EUPHRASIA STRICTA; HYDROFLUORIC ACID; IODINE; LEDUM PALUSTRE TWIG; NAPHTHALENE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TELLURIUM; ZINC 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4589_99277d8a-196f-3b89-7274-d5f64fcbe93b 55714-4589 HUMAN PRESCRIPTION DRUG Cataracts Arsenicum alb., Bryonia, Calc. fluor., Calendula, Causticum, Conium , Euphrasia, Hydrofluoricum acidum, Iodium, Ledum, Naphthalinum, Nat. mur., Nux vom., Phosphorus, Pulsatilla, Sepia, Silicea, Tellurium metallicum, Thiosinaminum, Zinc. met. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALLYLTHIOUREA; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; HYDROFLUORIC ACID; IODINE; LEDUM PALUSTRE TWIG; NAPHTHALENE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TELLURIUM; ZINC 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4590_823f0673-41cb-3f7a-f27b-c7ab9f908edd 55714-4590 HUMAN PRESCRIPTION DRUG Childbirth Support Arnica, Caulophyllum, Cimicifuga, Gelsemium, Pulsatilla LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARNICA MONTANA; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA VULGARIS 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-4591_9bd8e15f-445b-0f3c-d8ea-3ea642c1dd01 55714-4591 HUMAN PRESCRIPTION DRUG Childbirth Support Arnica, Caulophyllum, Cimicifuga, Gelsemium, Pulsatilla PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARNICA MONTANA; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA VULGARIS 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 55714-4592_659200cf-e603-f19a-de8e-509929ececee 55714-4592 HUMAN PRESCRIPTION DRUG Female Fibroids Arsenicum alb., clacarea iodata, Carbo animalis, Conium, Graphites, Hydrastis, Iodium, Kreosotum, Lachesis, Phosphorus, Sabina, Secale, Sepia, Silicea, Thlaspi, Thuja occ., Thyroidinum, Trillium pendulum, Ustilago maidis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; CALCIUM IODIDE; CAPSELLA BURSA-PASTORIS; CARBO ANIMALIS; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; GRAPHITE; IODINE; JUNIPERUS SABINA LEAFY TWIG; LACHESIS MUTA VENOM; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRILLIUM ERECTUM ROOT; USTILAGO MAYDIS; WOOD CREOSOTE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 55714-4593_b65fde64-799e-6040-6f08-ff6f82b019a2 55714-4593 HUMAN PRESCRIPTION DRUG Female Fibroids Arsenicum alb., clacarea iodata, Carbo animalis, Conium, Graphites, Hydrastis, Iodium, Kreosotum, Lachesis, Phosphorus, Sabina, Secale, Sepia, Silicea, Thlaspi, Thuja occ., Thyroidinum, Trillium pendulum, Ustilago maidis PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; CALCIUM IODIDE; CAPSELLA BURSA-PASTORIS; CARBO ANIMALIS; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; GRAPHITE; IODINE; JUNIPERUS SABINA LEAFY TWIG; LACHESIS MUTA VENOM; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRILLIUM ERECTUM ROOT; USTILAGO MAYDIS; WOOD CREOSOTE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 55714-4596_20dbecf0-26a9-1ec7-28d6-d855ad3dc3ca 55714-4596 HUMAN PRESCRIPTION DRUG Eye Floaters Aloe, Carbo veg., Causticum,Chelidonium majus, Cholesterinum, Cinchona, Colchicum, Cyclamen, Gelsemium, Kali carb., Merc. viv.,Phosphorus, hysostigma, Prunus spin., Senega officinalis, Sepia, Sulphur, Tabacum, Euphrasia LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ALOE; CAUSTICUM; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CYCLAMEN PURPURASCENS TUBER; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; MERCURY; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED; POLYGALA SENEGA ROOT; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; SEPIA OFFICINALIS JUICE; SULFUR; TOBACCO LEAF 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 55714-4597_a37fbbf9-acfb-c288-4a3e-92a020adf3fd 55714-4597 HUMAN PRESCRIPTION DRUG Eye Floaters Aloe, Carbo veg., Causticum,Chelidonium majus, Cholesterinum, Cinchona, Colchicum, Cyclamen, Gelsemium, Kali carb., Merc. viv.,Phosphorus, hysostigma, Prunus spin., Senega officinalis, Sepia, Sulphur, Tabacum, Euphrasia PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ALOE; CAUSTICUM; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CYCLAMEN PURPURASCENS TUBER; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; MERCURY; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED; POLYGALA SENEGA ROOT; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; SEPIA OFFICINALIS JUICE; SULFUR; TOBACCO LEAF 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 55714-4598_c98ecee8-3d53-392a-8a79-459cebd19d1e 55714-4598 HUMAN PRESCRIPTION DRUG Macular Degeneration Elaps corallinus, Aconitum nap.,Aur. met., Baryta carb., Belladonna, Crotalus horridus, Gelsemium, Hamamelis, Lachesis, Merc. viv.,Phosphorus, Picricum ac., Plumbum met., Pulsatilla,Rhus toxicodendron, Stramonium, Theridion, Euphrasia LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; BARIUM CARBONATE; CROTALUS HORRIDUS HORRIDUS VENOM; DATURA STRAMONIUM; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; GOLD; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; LEAD; MERCURY; MICRURUS CORALLINUS VENOM; PHOSPHORUS; PICRIC ACID; PULSATILLA VULGARIS; THERIDION CURASSAVICUM; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 55714-4599_3a2e93e4-3405-038f-b134-22a5fd35dbf4 55714-4599 HUMAN PRESCRIPTION DRUG Macular Degeneration Elaps corallinus, Aconitum nap.,Aur. met., Baryta carb., Belladonna, Crotalus horridus, Gelsemium, Hamamelis, Lachesis, Merc. viv.,Phosphorus, Picricum ac., Plumbum met., Pulsatilla,Rhus toxicodendron, Stramonium, Theridion, Euphrasia PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; BARIUM CARBONATE; CROTALUS HORRIDUS HORRIDUS VENOM; DATURA STRAMONIUM; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; GOLD; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; LEAD; MERCURY; MICRURUS CORALLINUS VENOM; PHOSPHORUS; PICRIC ACID; PULSATILLA VULGARIS; THERIDION CURASSAVICUM; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 55714-4606_0a0eb82b-be51-38af-b868-9f3e387f1263 55714-4606 HUMAN PRESCRIPTION DRUG Cell Salts Calc. fluor., Calc. phos., Calc. sulph., Ferrum phosphoricum, Kali mur., Kali phos., Kali sulph., Mag. phos., Nat. mur., Nat. phos., Nat. sulphuricum, Silicea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 55714-4607_106936bd-ed16-bed3-8b2d-02b14750c2a8 55714-4607 HUMAN PRESCRIPTION DRUG Cell Salts Calc. fluor., Calc. phos., Calc. sulph., Ferrum phosphoricum, Kali mur., Kali phos., Kali sulph., Mag. phos., Nat. mur., Nat. phos., Nat. sulphuricum, Silicea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 55714-4612_d062da5b-fd1c-a3a2-56b1-bad8a3c5838b 55714-4612 HUMAN PRESCRIPTION DRUG Restless Leg Mygale, Agaricus musc., Causticum, Cinchona, Conium, Cuprum met., Gelsemium, Hyoscyamus, Hypericum, Kali carb, Mag.carb, Merc. viv., Nux vom., Plumb. met., Rhus toxicodendron, Secale, Strychninum, Tarentula hispana, Valeriana, Verbascum, Zinc. met., Chamomilla, Passiflora LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AVICULARIA AVICULARIA; CAUSTICUM; CINCHONA OFFICINALIS BARK; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; COPPER; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; LEAD; LYCOSA TARANTULA; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; MERCURY; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; STRYCHNINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VALERIAN; VERBASCUM THAPSUS; ZINC 10; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 3; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4613_a7de20a6-c9f7-0303-22e1-659794b081bb 55714-4613 HUMAN PRESCRIPTION DRUG Restless Leg Mygale, Agaricus musc., Causticum, Cinchona, Conium, Cuprum met., Gelsemium, Hyoscyamus, Hypericum, Kali carb, Mag.carb, Merc. viv., Nux vom., Plumb. met., Rhus toxicodendron, Secale, Strychninum, Tarentula hispana, Valeriana, Verbascum, Zinc. met., Chamomilla, Passiflora PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AVICULARIA AVICULARIA; CAUSTICUM; CINCHONA OFFICINALIS BARK; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; COPPER; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; LEAD; LYCOSA TARANTULA; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; MERCURY; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM CARBONATE; STRYCHNINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VALERIAN; VERBASCUM THAPSUS; ZINC 10; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 3; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4618_f3047949-5e7a-5237-b6fa-2255dd2f681a 55714-4618 HUMAN PRESCRIPTION DRUG Fungal Infection Candida albicans, Sanicula, Tellurium metallicum, Torula cerevisiae, Antimon. crud., Arsenicum alb., Baryta carb., Bryonia, Calc. carb., Carbo veg., Cuprum met., Dulcamara, Graphites, Kali carb., Lachesis, Lycopodium, Mezereum, Nitricum ac., Phosphorus, Phytolacca, Sepia, Silicea, Sulphur, Sulphuricum ac., Zinc. met., Apis mel., Thuja. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; CANDIDA ALBICANS; COPPER; DAPHNE MEZEREUM BARK; GRAPHITE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; SACCHAROMYCES CEREVISIAE; SANICULA EUROPAEA LEAF; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; SULFUR; SULFURIC ACID; TELLURIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 15; 15; 8; 15; 15; 15; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 20; 20; 15; 15; 15; 15; 15; 20; 8; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4624_ad75f5e3-44f2-c33c-3803-28aa6cf33ff3 55714-4624 HUMAN PRESCRIPTION DRUG Prime of Life Agnus, Allium sativum, Ambra, Angelica sinensis radix , Aralia quinquefolia, Arnica , Arsenicum alb., Avena, Baptisia, Baryta carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux vom., Phosphoricum ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc.met.,Ginkgo LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMBERGRIS; AMERICAN GINSENG; ANGELICA SINENSIS ROOT; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; CHASTE TREE; GARLIC; GINKGO; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; STRYCHNOS NUX-VOMICA SEED; ZINC 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4625_e8800054-6a29-d658-ba90-f45c52eb6d22 55714-4625 HUMAN PRESCRIPTION DRUG Prime of Life Agnus, Allium sativum, Ambra, Angelica sinensis radix , Aralia quinquefolia, Arnica , Arsenicum alb., Avena, Baptisia, Baryta carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux vom., Phosphoricum ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc.met.,Ginkgo PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMBERGRIS; AMERICAN GINSENG; ANGELICA SINENSIS ROOT; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; CHASTE TREE; GARLIC; GINKGO; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; STRYCHNOS NUX-VOMICA SEED; ZINC 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4626_1968457a-108f-bca6-5aa5-95fdee457f2f 55714-4626 HUMAN PRESCRIPTION DRUG Panic Ease Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus canadensis, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus spin., Rhus toxicodendron, Sarcolacticum ac., Sulphur, Veratrum alb., Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; DAPHNE MEZEREUM BARK; FERROSOFERRIC PHOSPHATE; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; LACTIC ACID, L-; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; STRYCHNOS IGNATII SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; VALERIAN; VERATRUM ALBUM ROOT 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4627_1b6563cd-8c6e-00b8-6d10-d0d792d9c5c9 55714-4627 HUMAN PRESCRIPTION DRUG Panic Ease Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus canadensis, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus spin., Rhus toxicodendron, Sarcolacticum ac., Sulphur, Veratrum alb., Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; DAPHNE MEZEREUM BARK; FERROSOFERRIC PHOSPHATE; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; LACTIC ACID, L-; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; STRYCHNOS IGNATII SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; VALERIAN; VERATRUM ALBUM ROOT 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4628_17b4a181-d138-0f08-71d1-b695600a1a73 55714-4628 HUMAN PRESCRIPTION DRUG Multi-System Support Aspergillus niger, Cladosporium, Candida albicans, Thyroidinum, Ustilago maidis, Aconitum nap., Antimonium tart. Aralia quinquefolia, Arnica, Arsenicum alb., Baptisia, Bryonia, Cantharis, Chelidonium majus, Cinchona, Echinacea, Iodium, Kali carb. Kali iod., Lachesis, Lycopodium Lycopus virginicus, Nat. mur., Nux vom., Phosphorus, Phytolacca, Pulsatilla, Rhus toxicodendron, Sabal LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMERICAN GINSENG; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CANDIDA ALBICANS; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CLADOSPORIUM HERBARUM; ECHINACEA, UNSPECIFIED; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; LYTTA VESICATORIA; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; SAW PALMETTO; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF; USTILAGO MAYDIS 10; 10; 10; 10; 10; 15; 10; 10; 15; 10; 10; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4629_6a307bd5-07e0-209c-c4bd-3fc8a6b69535 55714-4629 HUMAN PRESCRIPTION DRUG Multi-System Support Aspergillus niger, Cladosporium, Candida albicans, Thyroidinum, Ustilago maidis, Aconitum nap., Antimonium tart. Aralia quinquefolia, Arnica, Arsenicum alb., Baptisia, Bryonia, Cantharis, Chelidonium majus, Cinchona, Echinacea, Iodium, Kali carb. Kali iod., Lachesis, Lycopodium Lycopus virginicus, Nat. mur., Nux vom., Phosphorus, Phytolacca, Pulsatilla, Rhus toxicodendron, Sabal PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMERICAN GINSENG; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CANDIDA ALBICANS; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CLADOSPORIUM HERBARUM; ECHINACEA, UNSPECIFIED; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; LYTTA VESICATORIA; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; SAW PALMETTO; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF; USTILAGO MAYDIS 10; 10; 10; 10; 10; 15; 10; 10; 15; 10; 10; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 55714-4631_599bcf93-2495-7218-b15b-9b7731f2786e 55714-4631 HUMAN PRESCRIPTION DRUG Immune Waker Influenzinum, Pyrogenium, Anthracinum,Arnica, Belladonna, Cantharis, Aconitum nap., Arsenicum alb., Baptisia, Bryonia, Hepar sulph. calc., Iodium, Lachesis, Merc. viv., Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Apis mel., Echinacea, Hydrastis, Thuja occ. PLASTER ORAL 20131230 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IODINE; LACHESIS MUTA VENOM; LYTTA VESICATORIA; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; RANCID BEEF; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 10; 3; 15; 10; 15; 15; 10; 10; 10; 3; 3; 30; 30; 10; 10; 15; 10; 10; 10; 30; 10; 3; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4633_66c06ccb-d349-6181-0a17-61e50d6b0f21 55714-4633 HUMAN PRESCRIPTION DRUG Immune Waker Influenzinum, Pyrogenium, Anthracinum,Arnica, Belladonna, Cantharis, Aconitum nap., Arsenicum alb., Baptisia, Bryonia, Hepar sulph. calc., Iodium, Lachesis, Merc. viv., Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Apis mel., Echinacea, Hydrastis, Thuja occ. PELLET ORAL 20140701 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IODINE; LACHESIS MUTA VENOM; LYTTA VESICATORIA; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; RANCID BEEF; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 10; 3; 15; 10; 15; 15; 10; 10; 10; 3; 3; 30; 30; 10; 10; 15; 10; 10; 10; 30; 10; 3; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4634_575e0ba9-8135-34c4-a0c9-6920b838c90c 55714-4634 HUMAN PRESCRIPTION DRUG Immune Waker Influenzinum, Anthracinum, Arnica, Belladonna, Aconitum nap., Arsenicum alb., Baptisia, Bryonia, Hepar sulph. calc., Iodium, Lachesis, Lycopodium, Merc. viv., Nux vom., Phos., Pulsatilla, Rhus tox., Apis mel., Echinacea, Hydrastis, Thuja occ., Aaricus musc,. Allium sat., Aloe, Calc. carb., Calendula, Capiscum, Carduus mar., Salvia, Selenium, Taraxacum, Tarentula hisp., Zinc. met., Zingiber LIQUID ORAL 20141110 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALOE; AMANITA MUSCARIA FRUITING BODY; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; AZADIRACHTA INDICA BARK; BACILLUS ANTHRACIS; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; ECHINACEA, UNSPECIFIED; GARLIC; GINGER; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; MERCURY; MILK THISTLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SAGE; SELENIUM; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; ZINC 15; 15; 15; 8; 15; 15; 15; 15; 20; 15; 15; 15; 15; 15; 8; 15; 15; 8; 35; 35; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 55714-4635_d7bea61e-c664-40ae-01ef-61d67ce788cc 55714-4635 HUMAN PRESCRIPTION DRUG Immune Waker Influenzinum, Anthracinum, Arnica, Belladonna, Aconitum nap., Arsenicum alb., Baptisia, Bryonia, Hepar sulph. calc., Iodium, Lachesis, Lycopodium, Merc. viv., Nux vom., Phos., Pulsatilla, Rhus tox., Apis mel., Echinacea, Hydrastis, Thuja occ., Aaricus musc,. Allium sat., Aloe, Calc. carb., Calendula, Capiscum, Carduus mar., Salvia, Selenium, Taraxacum, Tarentula hisp., Zinc. met., Zingiber PELLET ORAL 20141110 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALOE; AMANITA MUSCARIA FRUITING BODY; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; AZADIRACHTA INDICA BARK; BACILLUS ANTHRACIS; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; ECHINACEA, UNSPECIFIED; GARLIC; GINGER; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; MERCURY; MILK THISTLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SAGE; SELENIUM; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; ZINC 15; 15; 15; 8; 15; 15; 15; 15; 20; 15; 15; 15; 15; 15; 8; 15; 15; 8; 35; 35; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 55714-6063_0a931929-0ea5-4d0f-e054-00144ff88e88 55714-6063 HUMAN OTC DRUG Arnica montana Arnica montana LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARNICA MONTANA 15 [hp_X]/mL 55714-6083_ec0dda76-af8a-252f-eee8-91753ef2144e 55714-6083 HUMAN PRESCRIPTION DRUG Borrelia burgdorferi Borrelia burgdorferi LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BORRELIA BURGDORFERI 200 [hp_C]/mL 55714-6091_e8c41007-d7a8-0523-8528-329f2ca2c36f 55714-6091 HUMAN OTC DRUG Belladonna Belladonna LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ATROPA BELLADONNA 15 [hp_X]/mL 55714-6107_373240cd-cd31-6695-e4c5-07bb1a1e9ee7 55714-6107 HUMAN OTC DRUG Bryonia Bryonia LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BRYONIA ALBA ROOT 15 [hp_X]/mL 55714-6117_c1a95727-dbc8-e388-1347-f18da842f144 55714-6117 HUMAN OTC DRUG Calcarea fluorica Calcarea fluorica LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CALCIUM FLUORIDE 15 [hp_X]/mL 55714-6174_2be09477-44b9-47b9-a074-f612d894a97b 55714-6174 HUMAN OTC DRUG Convallaria majalis Convallaria majalis LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CONVALLARIA MAJALIS 15 [hp_X]/mL 55714-6242_6e724197-336a-9bf6-54a0-3cfdff380e01 55714-6242 HUMAN OTC DRUG Gelsemium sempervirens Gelsemium sempervirens LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X]/mL 55714-6275_4085295e-d357-0f8c-e826-0776dfb22d03 55714-6275 HUMAN OTC DRUG Hypericum perforatum Hypericum perforatum LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. HYPERICUM PERFORATUM 15 [hp_X]/mL 55714-6283_d40d68f6-6763-50b4-deae-683607daca55 55714-6283 HUMAN OTC DRUG Iodium Iodium LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. IODINE 15 [hp_X]/mL 55714-6297_55de6643-dc8f-aaf7-0228-3ab198b734d7 55714-6297 HUMAN OTC DRUG Kali muriaticum Kali muriaticum LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. POTASSIUM CHLORIDE 15 [hp_X]/mL 55714-6306_2e6c1ec2-cbff-b6d1-8840-69b6f0263432 55714-6306 HUMAN OTC DRUG Lachesis mutus Lachesis mutus LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. LACHESIS MUTA VENOM 15 [hp_X]/mL 55714-6387_73e42b76-609e-edfe-777b-cd5fe4161149 55714-6387 HUMAN OTC DRUG Nux vomica Nux vomica LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/mL 55714-6417_6cc8d34c-c5d9-deb5-22eb-d53b6fe1ec6b 55714-6417 HUMAN OTC DRUG Phosphorus Phosphorus LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. PHOSPHORUS 15 [hp_X]/mL 55714-6453_5baa5348-4b84-6d65-5030-dfa8315f0972 55714-6453 HUMAN OTC DRUG Hypothalamus Hypothalamus LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BOS TAURUS HYPOTHALAMUS 15 [hp_X]/mL 55714-6516_f3151f1a-7eb9-d350-f133-c7d5907b2ddc 55714-6516 HUMAN OTC DRUG Sulphur Sulphur LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. SULFUR 15 [hp_X]/mL 55714-6540_8f19025a-7fcb-62f6-e19f-88b8b307ae17 55714-6540 HUMAN OTC DRUG Thuja occidentalis Thuja occidentalis LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. THUJA OCCIDENTALIS LEAFY TWIG 15 [hp_X]/mL 55714-6612_eb1ffc5c-6e02-3a0e-a35c-ba242c431663 55714-6612 HUMAN PRESCRIPTION DRUG Parathyroid Parathyroid LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. HUMAN PARATHYROID 15 [hp_X]/mL 55714-6634_bd01837d-3c83-cf38-a697-fb208ff717cf 55714-6634 HUMAN PRESCRIPTION DRUG Progesterone Progesterone LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. PROGESTERONE 15 [hp_X]/mL Progesterone [Chemical/Ingredient],Progesterone [EPC] 55714-7387_86d29360-f4a2-f1f7-f9a2-66d42d704456 55714-7387 HUMAN OTC DRUG Nux vomica Nux vomica PELLET ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/g 55714-7540_dbdbfe9b-b84a-cf6b-3774-4f1f46c934ea 55714-7540 HUMAN OTC DRUG Thuja occidentalis Thuja occidentalis PELLET ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. THUJA OCCIDENTALIS LEAFY TWIG 15 [hp_X]/g 55714-8000_fd162601-1b55-1a68-6820-d9707a7fac8d 55714-8000 HUMAN OTC DRUG Detox Uricum acidum, Benzoicum acidum, Berber. vulg., Bryonia, Cantharis, Carduus benedictus, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Dioscorea, Dolichos, Iris versicolor, Juniperus com., Nux vom.,Ptelea,Taraxacum, Carduus mar., Cynara scolymus, Solidago LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; DIOSCOREA VILLOSA TUBER; IRIS VERSICOLOR ROOT; JUNIPER BERRY; LYTTA VESICATORIA; MUCUNA PRURIENS FRUIT TRICHOME; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; URIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 3; 10; 10; 10; 10; 10; 10; 3; 3; 10; 10; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-8001_4a11b0df-0228-81ff-510f-20a7d05b4fc2 55714-8001 HUMAN OTC DRUG Stress - Panic Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus canadensis, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus spin., Rhus toxicodendron, Sarcolacticum ac., Sulphur, Veratrum alb., Valeriana LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; DAPHNE MEZEREUM BARK; FERROSOFERRIC PHOSPHATE; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; LACTIC ACID, L-; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; STRYCHNOS IGNATII SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; VALERIAN; VERATRUM ALBUM ROOT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-8002_263d0205-1e8d-a697-fa3d-e190b77c1af9 55714-8002 HUMAN OTC DRUG Nausea Bismuthum metallicum, Bryonia, Cimicifuga, Gossypium herbaceum, Ipecac., Kreosotum, Lycopodium, Mag. carb., Nux vom., Pulsatilla, Sepia, Symphoricarpus racemosus, Tabacum, Zingiber, Chamomilla, Hydrastis, Iris versicolor LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BISMUTH; BLACK COHOSH; BRYONIA ALBA ROOT; GINGER; GOLDENSEAL; GOSSYPIUM HERBACEUM ROOT BARK; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SYMPHORICARPOS ALBUS FRUIT; TOBACCO LEAF; WOOD CREOSOTE 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-8003_771b261c-4e79-62fc-e59a-7075b138e8cf 55714-8003 HUMAN OTC DRUG Bites - Stings Pyrogenium, Apis mel., Aranea diadema, Arnica, Arsenicum alb., Azadirachta indica, Bryonia, Caladium seguinum, Calendula, Formica, Grindelia, Hypericum, Lachesis, Latrodectus mactans, Ledum, Mezereum, Nux vom., Pulex irritans, Rhus toxicodendron, Tarentula cubensis, Tarentula hispana, Theridion, Thuja occ., Vespa crabro, Echinacea, Hamamelis, Solidago LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARANEUS DIADEMATUS; ARNICA MONTANA; ARSENIC TRIOXIDE; AZADIRACHTA INDICA BARK; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CITHARACANTHUS SPINICRUS; DAPHNE MEZEREUM BARK; DIEFFENBACHIA SEGUINE; ECHINACEA, UNSPECIFIED; FORMICA RUFA; GRINDELIA HIRSUTULA FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; LYCOSA TARANTULA; PULEX IRRITANS; RANCID BEEF; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; VESPA CRABRO 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 30; 3; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-8004_75e10547-4cb7-7867-5da9-b339676fa3c8 55714-8004 HUMAN OTC DRUG Injury Rescue Aconitum nap, Arnica, Bellis, Calendula, Echinacea, Gelsemium, Hamamelis, Hypericum, Ledum, Phosphorus, Rhus toxicodendron, Ruta, Staphysag., Symphytum, Hydrastis canadensis. LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-8005_6875ba7a-d7cf-80d6-5be0-a250351a7211 55714-8005 HUMAN OTC DRUG Bowel - Digestive Care Bismuthum metallicum, Antimon.crud., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Chamomilla, Cinchona, Iris versicolor, Kali bic., Lachesis, Lycopodium, Mag. carb., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Raphanus, Rhus toxicodendron, Tabacum, Verbascum, Zingiber, Echinacea, Juglans regia. LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT; GINGER; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MATRICARIA RECUTITA; PHOSPHORUS; PODOPHYLLUM; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RADISH; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 10; 10; 10; 15; 10; 10; 3; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-8006_ae43f96a-4c53-d83a-ae99-c83f70586cac 55714-8006 HUMAN OTC DRUG Kidney - Bladder Apis mel., Berber. vulg., Bryonia, Cantharis, Cinchona, Equisetum hyemale, Ferrum phosphoricum, Gelsemium, Juniperus com., Pareira, Phosphorus, Plantago, Pulsatilla, Sabal, Terebinthina, Uva-ursi, Echinacea, Hydrastis, Lappa, Solidago LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARCTIUM LAPPA ROOT; ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHONDRODENDRON TOMENTOSUM ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EQUISETUM HYEMALE; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; JUNIPER BERRY; LYTTA VESICATORIA; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; TURPENTINE OIL 15; 3; 15; 15; 15; 15; 15; 3; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-8007_7db80e8d-bd3c-4752-eb9e-bff9e2f02226 55714-8007 HUMAN OTC DRUG Cold - Sinus Influenza A Virus, Influenza B Virus, Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procubens, Gelsemium, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Kali bic., Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabadilla, Salvia, Sticta, Verbascum, Echinacea LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LOBARIA PULMONARIA; MERCURY; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SAGE; SCHOENOCAULON OFFICINALE SEED; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-8008_de4b8961-2876-2846-5e54-03aeb253a70a 55714-8008 HUMAN OTC DRUG Pain Soother Aconitum nap., Arg. nit., Arnica, Bryonia, Colchicum, Guaiacum, Hypericum, Kalmia, Phosphorus, Phytolacca, Pulsatilla, Rhus toxicodendron, Ruta, Sarcolacticum ac., Sticta, Stramonium, Hamamelis, Taraxacum, LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; DATURA STRAMONIUM; GUAIAC; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; LACTIC ACID, L-; LOBARIA PULMONARIA; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SILVER NITRATE; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-8009_5769c34d-ff42-67a2-4e09-31ea79130844 55714-8009 HUMAN OTC DRUG Fever - Infection Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Aconitum nap., Antimon. tart., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Cinchona, Eupatorium perf., Ferrum metallicum, Gelsemium, Hepar sulph.calc., Iodium, Lachesis, Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Salix nigra, Verbascum, Apis mel., Echinacea, Hydrastis LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; IODINE; IRON; LACHESIS MUTA VENOM; LYTTA VESICATORIA; MATRICARIA RECUTITA; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; RANCID BEEF; SALIX NIGRA BARK; TOXICODENDRON PUBESCENS LEAF; VERBASCUM THAPSUS 15; 15; 3; 15; 15; 15; 30; 15; 15; 15; 15; 3; 15; 15; 3; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-8010_e35b9109-3d1b-fe6c-fd86-569bd9247d17 55714-8010 HUMAN OTC DRUG Sick Stopper Anthracinum, Influenzinum, Pyrogenium, Bufo rana, Aconitum nap., Agaricus musc., Aralia quinquefolia, Baptisia, Bryonia, Chelidonium majus, Eupatorium perf., Hepar sulph. calc., Lachesis, Lycopodium, Nux vom., Rhus toxicodendron, Sanguinaria, Sulphur, Thuja occ., Echinacea LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; BUFO BUFO CUTANEOUS GLAND; CALCIUM SULFIDE; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; RANCID BEEF; SANGUINARIA CANADENSIS ROOT; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 30; 10; 10; 15; 10; 10; 3; 10; 30; 30; 10; 10; 30; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-8011_35068aee-7a2f-3b17-26f6-67ad537f5900 55714-8011 HUMAN OTC DRUG Parasites Abrotanum, Aesculus hipp., Allium sativum, Arsenicum alb., Artemisia, Baptisia, Cina, Cuprum met., Filix mas, Granatum, Ipecac, Lachesis, Lycopodium, Merc. viv, Naphthalinum, Nat. mur., Nux vom., Pulsatilla, Ratanhia, Ruta, Sabadilla, Santoninum, Silicea, Spigelia anth., Terebinthina, Teucrium marum, Thymolum, Zingiber, Juglans regia LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; ARTEMISIA CINA PRE-FLOWERING TOP; ARTEMISIA VULGARIS ROOT; BAPTISIA TINCTORIA; COPPER; DRYOPTERIS FILIX-MAS ROOT; ENGLISH WALNUT; GARLIC; GINGER; HORSE CHESTNUT; IPECAC; KRAMERIA LAPPACEA ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; NAPHTHALENE; PULSATILLA VULGARIS; PUNICA GRANATUM ROOT BARK; RUTA GRAVEOLENS FLOWERING TOP; SANTONIN; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM; THYMOL; TURPENTINE OIL 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-8012_d5f4f06b-6240-90c4-45f1-0e769f3da60b 55714-8012 HUMAN OTC DRUG Inflammation Anthracinum, Pyrogenium, Aconitum nap., Aloe, Apis mel., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chelidonium majus, Crotalus horridus, Ferrum phosphoricum, Gaultheria procumbens, Hepar sulph. calc., Iodium, Lachesis, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Veratrum viride, Verbascum, Echinacea LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ALOE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GAULTHERIA PROCUMBENS TOP; IODINE; LACHESIS MUTA VENOM; LYTTA VESICATORIA; PHOSPHORUS; PULSATILLA VULGARIS; RANCID BEEF; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VERATRUM VIRIDE ROOT; VERBASCUM THAPSUS 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-8013_c3978e7d-007c-5dbb-ed7a-4dd2914c9c21 55714-8013 HUMAN OTC DRUG Rashes - Hives Antimon. crud., Apis mel., Arsenicum alb., Berber. vulg., Bovista, Bryonia, Cantharis, Chelidonium majus, Croton, Dulcamara, Graphites, Histaminum hydrochloricum, Lycopodium, Mezereum, Nux vom., Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp., Taraxacum, Urtica ur. LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; GIANT PUFFBALL; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; KEROSENE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PULEX IRRITANS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SMILAX REGELII ROOT; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-8014_61febc3a-7ba9-6691-2b5b-89f1f8d10c15 55714-8014 HUMAN OTC DRUG Diarrhea Pyrogenium, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Carbo veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris versicolor, Lycopodium, Podoph. pelt., Raphanus, Tabacum, Vaccinium, Zingiber, Aesculus hipp., Juglans regia LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BILBERRY; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COLLINSONIA CANADENSIS ROOT; ECBALLIUM ELATERIUM FRUIT; ENGLISH WALNUT; GELSEMIUM SEMPERVIRENS ROOT; GINGER; HORSE CHESTNUT; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PODOPHYLLUM; RADISH; RANCID BEEF; SILVER NITRATE; TOBACCO LEAF 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 3; 15; 15; 15; 15; 15; 15; 30; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-8015_5caf8e08-3caf-085c-945a-6e1b73d1daa7 55714-8015 HUMAN OTC DRUG Cough - Asthma Influenza A Virus, Influenza B Virus, Antimon. tart., Arsenicum alb., Bryonia, Chelidonium majus, Cinchona, Drosera, Eucalyptus, Histaminum hydrochloricum, Hydrastis, Kali bic., Kali carb.,Kali iod., Myrrha, Nat. sulphuricum, Nux vom., Phosphorus, Pulsatilla, Rumex crisp., Sambucus nig., Spongia, Tussilago farfara, Verbascum, Echinacea, Lappa LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY POTASSIUM TARTRATE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA FLOWERING TOP; ECHINACEA, UNSPECIFIED; EUCALYPTUS GLOBULUS LEAF; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; MYRRH; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS NUX-VOMICA SEED; TUSSILAGO FARFARA; VERBASCUM THAPSUS 15; 3; 15; 15; 15; 15; 15; 3; 15; 15; 15; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55714-8016_7351145d-7651-a235-893b-e4a42afe97ee 55714-8016 HUMAN OTC DRUG Just In Case Aconitum nap., Arnica, Arsenicum alb., Bryonia, Echinacea, Ledum, Cenchris, Crotalus casc. Crotalus hor., Lachesis, Merc. corros., Naja, Phos., Toxicophis, Vipera, Elaps cor., Heloderma LIQUID ORAL 20141110 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AGKISTRODON CONTORTRIX VENOM; AGKISTRODON PISCIVORUS VENOM; ARNICA MONTANA; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CROTALUS DURISSUS TERRIFICUS VENOM; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; HELODERMA SUSPECTUM VENOM; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; MERCURIC CHLORIDE; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; PHOSPHORUS; VIPERA BERUS VENOM 10; 15; 15; 10; 10; 10; 15; 15; 10; 30; 15; 10; 15; 30; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55715-001_d474be62-1402-4a45-b3c6-a80ab641f556 55715-001 HUMAN OTC DRUG Zepol Topical Analgesic Camphor, Menthol OINTMENT TOPICAL 20091005 OTC MONOGRAPH NOT FINAL part348 Laboratorios Zepol S.A. CAMPHOR (SYNTHETIC); MENTHOL 6.55; 6.55 g/100g; g/100g 55715-002_a82d5d54-593e-4705-81ca-b749f208a428 55715-002 HUMAN OTC DRUG Manzatin-E Diaper Rash Skin Protectant Zinc Oxide OINTMENT TOPICAL 20091001 OTC MONOGRAPH FINAL part348 Laboratorios Zepol S.A. ZINC OXIDE 18 g/100g 55722-034_954098bd-23a0-4c60-8def-57cfe75df28b 55722-034 HUMAN OTC DRUG Youngevity Invision CM Menthol CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part348 Imagenetix MENTHOL 12.5 mg/g 55722-419_9cdba220-6919-4ba3-b6d6-e71d63f01360 55722-419 HUMAN OTC DRUG EFAC Pain Relieving Menthol CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part348 Imagenetix MENTHOL 12.5 mg/g 55724-111_eea4d660-6ac1-4f82-b15c-771dc281d2f5 55724-111 HUMAN PRESCRIPTION DRUG Kerydin Tavaborole SOLUTION TOPICAL 20140707 NDA NDA204427 Anacor Pharmaceuticals, Inc TAVABOROLE 43.5 mg/mL 55726-048_ecd7d694-324e-44a7-9b09-35d8f3fa4183 55726-048 HUMAN OTC DRUG ZeroSweat 3 DAY PROTECTION ANTIPERSPIRANT Aluminum Chloride LIQUID TOPICAL 20120611 OTC MONOGRAPH FINAL part350 ZeroSweat Inc ALUMINUM CHLORIDE 15 mg/mL 55728-001_0ede4e05-bbf7-4fe1-b9cc-962c813d98c9 55728-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19780102 NDA NDA205737 A & B Welding Supply Co. OXYGEN 990 mL/L 55728-002_210f43c7-27dc-48b8-b12f-206bfaf18aa5 55728-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20120109 NDA NDA205738 A & B Welding Supply Co. NITROGEN 990 mL/L 55739-1022_4e7ff19e-48ee-4d46-9b5f-c7ecd303d178 55739-1022 HUMAN OTC DRUG Perineze Triple Dye BRILLIANT GREEN, PROFLAVINE HEMISULFATE, GENTIAN VIOLET SOLUTION TOPICAL 20110928 OTC MONOGRAPH NOT FINAL part333E Peace Medical Inc. BRILLIANT GREEN; GENTIAN VIOLET; PROFLAVINE HEMISULFATE 2.29; 2.29; 1.14 mg/.61mL; mg/.61mL; mg/.61mL 55741-013_582919e1-b87d-477a-9b54-9bef01be65cb 55741-013 HUMAN OTC DRUG Bufferin Aspirin TABLET ORAL 20130515 OTC MONOGRAPH FINAL part343 Ducere Pharma LLC ASPIRIN 325 mg/1 55741-224_82388e0c-da5c-45e7-844d-3f55e16c63b2 55741-224 HUMAN OTC DRUG Doans Extra Strength Magnesium salicylate TABLET ORAL 20130515 OTC MONOGRAPH NOT FINAL part343 Ducere Pharma LLC MAGNESIUM SALICYLATE 580 mg/1 55741-304_93879770-1bc4-4a57-bc6b-ff0c5d049052 55741-304 HUMAN OTC DRUG Myoflex Trolamine salicylate CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 Ducere Pharma TROLAMINE SALICYLATE 10 g/100g 55741-402_d602dba8-d283-49ec-a422-1d02189a0064 55741-402 HUMAN OTC DRUG Nupercainal Dibucaine OINTMENT TOPICAL 20130701 OTC MONOGRAPH FINAL part346 Ducere Pharma DIBUCAINE 1 g/100g 55741-412_b8b95bde-20f8-4c08-aac9-dc4a8130d673 55741-412 HUMAN OTC DRUG Nupercainal Bio-Active Hemorrhoidal Hamamelis Virginiana Root Bark/Stem Bark, Echinacea purpurea, Centella asiatica, and Sambucus Nigra Flowering Top CREAM TOPICAL 20140407 UNAPPROVED HOMEOPATHIC Ducere Pharma CENTELLA ASIATICA; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; SAMBUCUS NIGRA FLOWERING TOP 5; 5; 5; 5 g/100g; g/100g; g/100g; g/100g 55741-424_1216c2b7-4a5d-43a9-b5f4-eb73c900b4ad 55741-424 HUMAN OTC DRUG Nupercainal Bio-Active Hemorrhoidal Echinacea purpurea, Centella asiatica, and Sambucus nigra flowering top SUPPOSITORY RECTAL 20140407 UNAPPROVED HOMEOPATHIC Ducere Pharma CENTELLA ASIATICA; ECHINACEA PURPUREA; SAMBUCUS NIGRA FLOWERING TOP .1; .1; .1 g/1; g/1; g/1 55749-002_d0381ff5-ae2e-489e-8b38-69152670b3a4 55749-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19870401 UNAPPROVED MEDICAL GAS American Welding & Gas OXYGEN 99 L/100L 55749-004_5c38c3d2-3639-493a-ac5a-22ec4d6e8c3a 55749-004 HUMAN PRESCRIPTION DRUG Nitrogen Nirtogen GAS RESPIRATORY (INHALATION) 19870401 UNAPPROVED MEDICAL GAS American Welding & Gas NITROGEN 99 L/100L 55749-005_ea7dd69a-e999-40e3-a59c-dab376c10de3 55749-005 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19870401 UNAPPROVED MEDICAL GAS American Welding & Gas OXYGEN 195 mL/1000mL 55749-100_6a10c651-a654-4211-bdec-f89f15f89908 55749-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19870401 NDA NDA205840 Industrial Gas Distributors Inc OXYGEN 990 mL/L 55749-300_a0f7bc45-7bce-46cb-8c7a-20b8cc3a3f3a 55749-300 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19870401 NDA NDA205839 Industrial Gas Distributors Inc NITROGEN 990 mL/L 55749-600_32c11310-a978-44b8-bf55-7befeeae3f5e 55749-600 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20020101 NDA NDA205704 Industrial Gas Distributors Inc NITROUS OXIDE 990 mL/L 5575-0001_40db3bde-e8b0-4e15-ac90-a393b61f92b6 5575-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140224 UNAPPROVED MEDICAL GAS Ecumed Inc dba Aronson Medical OXYGEN 99 L/100L 55754-000_1b16f8ba-e9bc-4f85-9ae2-d68193addfae 55754-000 HUMAN OTC DRUG Zohar finest Anticavity Sodium Fluoride MOUTHWASH ORAL 20140205 OTC MONOGRAPH FINAL part355 Broom Lane Enterprises SODIUM FLUORIDE .5 mg/mL 55754-121_fe287f6d-45e7-47ea-920c-12ca134d63e3 55754-121 HUMAN OTC DRUG Zohar Toothpaste Fresh Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110228 OTC MONOGRAPH FINAL part355 Broom Lane Enterprises SODIUM MONOFLUOROPHOSPHATE 11.5 mg/g 55754-122_0c56a265-60a1-4337-b245-99a631c63364 55754-122 HUMAN OTC DRUG Zohar Toothpaste Cool Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110228 OTC MONOGRAPH FINAL part355 Broom Lane Enterprises SODIUM MONOFLUOROPHOSPHATE 11.5 mg/g 55754-123_7fb0ecea-c5ac-4983-acf1-b4031a9cd110 55754-123 HUMAN OTC DRUG Zohar Toothpaste Regular Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110228 OTC MONOGRAPH FINAL part355 Broom Lane Enterprises SODIUM MONOFLUOROPHOSPHATE 11.5 mg/g 55758-001_dc1e4930-2a4b-4c2d-8f81-5a4466e12126 55758-001 HUMAN OTC DRUG DoloEar Atropa Belladonna, Apis Mellifera, Aristolochia Clematitis Root, Matricaria Recutita, Lachesis Muta Venom, and Thuja Occidentalis Leafy Twig SOLUTION/ DROPS AURICULAR (OTIC) 20130523 UNAPPROVED HOMEOPATHIC Pharmadel LLC APIS MELLIFERA; ARISTOLOCHIA CLEMATITIS ROOT; ATROPA BELLADONNA; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 6; 6; 6 [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL 55758-002_b20cf0b7-26d7-49a4-810b-ad45c86da53e 55758-002 HUMAN OTC DRUG Arnica ARNICA MONTANA TABLET ORAL 20130527 UNAPPROVED HOMEOPATHIC Pharmadel LLC ARNICA MONTANA 30 [hp_C]/1 55758-003_c1fbc7d9-b790-4442-aa91-8d19e8ef4f0d 55758-003 HUMAN OTC DRUG SanaTos COLD Multi-Symptom Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, and Chlorpheniramine Maleate KIT 20130325 OTC MONOGRAPH FINAL part341 Pharmadel LLC 55758-004_20cd6922-e370-4cce-affb-a049b9f8d500 55758-004 HUMAN OTC DRUG DOLEX Ibuprofen TABLET ORAL 20130325 ANDA ANDA079129 Pharmadel LLC IBUPROFEN 200 mg/1 55758-005_7a577a6f-9165-43bc-9191-2b7cecf40718 55758-005 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET ORAL 20130325 OTC MONOGRAPH NOT FINAL part356 Pharmadel LLC ASPIRIN 81 mg/1 55758-006_8b3c6efa-1d13-45df-bad7-fea06fc84091 55758-006 HUMAN OTC DRUG NAPROXEN Naproxen sodium TABLET ORAL 20130325 ANDA ANDA079096 Pharmadel LLC NAPROXEN SODIUM 220 mg/1 55758-007_d8b2960c-5812-4b47-a247-87c5f01771f6 55758-007 HUMAN OTC DRUG SanaTos Childrens Mucus Relief Cough DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN LIQUID ORAL 20131010 OTC MONOGRAPH FINAL part341 Pharmadel LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 55758-008_76dcd528-fdea-4099-9814-fc544097ee64 55758-008 HUMAN OTC DRUG Astroton Silver nitrate, Avena sativa flowering top, Turnera diffusa leafy twig, Lycopodium clavatum spore, Phosphoric acid, and Selenium TABLET ORAL 20131008 UNAPPROVED HOMEOPATHIC Pharmadel LLC AVENA SATIVA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SELENIUM; SILVER NITRATE; TURNERA DIFFUSA LEAFY TWIG 5; 5; 5; 5; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 55758-009_da17121b-e12a-4118-9b99-5626f6c587da 55758-009 HUMAN OTC DRUG SanaTos Severe Cold and Cough Nighttime Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride GRANULE, FOR SOLUTION ORAL 20140220 OTC MONOGRAPH FINAL part341 Pharmadel LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 55758-010_d9fb8b69-fb4b-4f2c-94b5-b0700ffc638d 55758-010 HUMAN OTC DRUG SanaTos Severe Cold and Cough Day Time Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride GRANULE, FOR SOLUTION ORAL 20140220 OTC MONOGRAPH FINAL part341 Pharmadel LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 55758-017_36c7de3c-5372-45d4-99c6-251235b1dc70 55758-017 HUMAN OTC DRUG Parche Leon Milagroso Capsaicin, Camphor, Menthol PATCH TOPICAL 20141205 OTC MONOGRAPH NOT FINAL part348 Pharmadel LLC CAMPHOR (SYNTHETIC); CAPSAICIN; MENTHOL 3; .025; 1.25 g/100g; g/100g; g/100g 55758-100_03f650e3-baca-4dde-be3d-b6af48027415 55758-100 HUMAN OTC DRUG Kofal T Methyl Salicylate OINTMENT TOPICAL 20120221 OTC MONOGRAPH FINAL part348 Pharmadel LLC METHYL SALICYLATE 6 g/g 55758-101_15daa7c7-e17e-434d-8509-0a33ab348e84 55758-101 HUMAN OTC DRUG Vapor Plus Camphor, Eucalyptus, Menthol OINTMENT TOPICAL 20120221 OTC MONOGRAPH NOT FINAL part348 Pharmadel LLC CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 5; 1; 3 g/g; g/g; g/g 55758-305_a6f85661-078f-4ddf-9605-5cee3e8d8726 55758-305 HUMAN OTC DRUG Estomax Bismuth Subsalicylate LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part335 Pharmadel LLC BISMUTH SUBSALICYLATE 262 mg/15mL 55777-0100_f9cbe524-b648-4468-9e70-94f0d552e743 55777-0100 HUMAN OTC DRUG Burn Out SPF-30 Sunscreen Zinc Oxide LOTION TOPICAL 20130912 OTC MONOGRAPH FINAL part352 Sun Research LLC ZINC OXIDE 20 g/100mL 55789-0101_0eaa0c8d-d12d-4f32-a23b-6c7e6f7b1399 55789-0101 HUMAN OTC DRUG SPF-40 facial moisturizer Zinc Oxide and Titanium dioxide LOTION TOPICAL 20121210 OTC MONOGRAPH NOT FINAL part352 Mineral Fusion brands TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5 g/100mL; g/100mL 55789-2400_a1adbbfb-f44a-421c-a28b-a68058711298 55789-2400 HUMAN OTC DRUG Perfecting Mineral Beauty Balm with SPF 9 Titanium Dioxide CREAM TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Mineral Fusion Natural Brands LLC TITANIUM DIOXIDE 39 mg/mL 55789-2401_a5d00319-22c6-4819-b69d-18a68a9daeb8 55789-2401 HUMAN OTC DRUG Illuminating Mineral Beauty Balm with SPF 9 Titanium Dioxide CREAM TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Mineral Fusion Natural Brands LLC TITANIUM DIOXIDE 74 mg/mL 55792-007_9abf7d1d-1434-4270-a3df-87c33343e5b8 55792-007 HUMAN PRESCRIPTION DRUG Elliotts B sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate INJECTION INTRATHECAL 20130604 NDA NDA020577 Lukare Medical, LLC ANHYDROUS DEXTROSE; CALCIUM CHLORIDE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE 8; 2; 3; 3; 19; 73; 2 mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 55806-020_d0d6ed35-8da8-4246-b7cc-0b1f3097097b 55806-020 HUMAN PRESCRIPTION DRUG methazolamide methazolamide TABLET ORAL 19940718 ANDA ANDA040062 Effcon Laboratories, Inc. METHAZOLAMIDE 50 mg/1 55806-021_d0d6ed35-8da8-4246-b7cc-0b1f3097097b 55806-021 HUMAN PRESCRIPTION DRUG methazolamide methazolamide TABLET ORAL 19940714 ANDA ANDA040062 Effcon Laboratories, Inc. METHAZOLAMIDE 25 mg/1 55814-101_9f65092c-ce91-4e09-92a6-31ed3fb2f3cd 55814-101 HUMAN OTC DRUG HAND SANITIZING LAVENDER ALCOHOL SPRAY TOPICAL 20120218 OTC MONOGRAPH FINAL part333E DR. BRONNER'S MAGIC SOAPS ALCOHOL 62 mL/100mL 55856-0002_14828c2b-fda1-4539-8ba6-eba09c0b54ce 55856-0002 HUMAN OTC DRUG THYROID SUPPORT CAUSTICUM, NATRUM MURIATICUM, CALCAREA IODATA, FUCUS VESICULOSUS, KALI IODATUM, FERRUM IODATUM, THYROIDINUM (BOVINE) LIQUID ORAL 20141212 UNAPPROVED HOMEOPATHIC Life Choice Ltd. CALCIUM IODIDE; CAUSTICUM; FERROUS IODIDE; FUCUS VESICULOSUS; POTASSIUM IODIDE; SODIUM CHLORIDE; THYROID, BOVINE 6; 3; 8; 6; 6; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55856-0003_186066ab-3f6f-400a-bb08-aec56b7f1af5 55856-0003 HUMAN PRESCRIPTION DRUG HGH Plus Adrenalinum, Thyroidinum (suis), Insulinum, Pituitaria Glandula (suis), LIQUID ORAL 20140310 UNAPPROVED HOMEOPATHIC Life Choice Ltd. EPINEPHRINE; INSULIN HUMAN; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID 9; 12; 12; 9 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Insulin [Chemical/Ingredient],Insulin [EPC] 55863-281_5de72152-9b3f-426d-9916-df7e9ef384b4 55863-281 HUMAN OTC DRUG SoftCIDE-ES SoftCIDE-ES LIQUID TOPICAL 20130613 OTC MONOGRAPH NOT FINAL part333E Erie Scientific, LLC CHLOROXYLENOL 12.604 g/100mL 55863-431_9f9a0274-9fb4-4a96-b036-20ff1295c1f3 55863-431 HUMAN OTC DRUG Alcoscrub Foam Alcoscrub Foam LIQUID TOPICAL 20060112 OTC MONOGRAPH NOT FINAL part333E Erie Scientific, LLC ALCOHOL 1 mL/mL 55863-700_81b6e3a7-2c4b-45b3-9ac6-d9fc6ed86415 55863-700 HUMAN OTC DRUG Alcoscrub Hand Cleaner Alcohol LIQUID TOPICAL 20090103 OTC MONOGRAPH NOT FINAL part333E Erie Scientific, LLC. ALCOHOL 1 mL/mL 55873-001_ea41661a-f6c8-4ca7-958f-f68fd9dbdb73 55873-001 HUMAN OTC DRUG OralLine Secure SODIUM FLUORIDE PASTE, DENTIFRICE ORAL 19660101 OTC MONOGRAPH FINAL part355 J.M. Murray Center Inc. SODIUM FLUORIDE .24 g/100g 55873-002_ea41661a-f6c8-4ca7-958f-f68fd9dbdb73 55873-002 HUMAN OTC DRUG OralLine SODIUM FLUORIDE GEL, DENTIFRICE ORAL 19660101 OTC MONOGRAPH FINAL part355 J.M. Murray Center Inc. SODIUM FLUORIDE .24 g/100g 55873-003_146dc009-aa0a-41d1-bbfb-207cb08843b8 55873-003 HUMAN OTC DRUG OralLine Kids SODIUM FLUORIDE GEL, DENTIFRICE ORAL 19660101 OTC MONOGRAPH FINAL part355 J.M. Murray Center Inc. SODIUM FLUORIDE .24 g/100g 55873-004_146dc009-aa0a-41d1-bbfb-207cb08843b8 55873-004 HUMAN OTC DRUG OralLine Kids SODIUM FLUORIDE GEL, DENTIFRICE ORAL 19660101 OTC MONOGRAPH FINAL part355 J.M. Murray Center Inc. SODIUM FLUORIDE .24 g/100g 55873-021_9bb30d63-c52e-4a56-b779-6321c81a7397 55873-021 HUMAN OTC DRUG OraLine-Secure CLEAR ANTIPERSPIRANT/DEODORANT ALUMINUM CHLOROHYDRATE GEL TOPICAL 20140501 OTC MONOGRAPH FINAL part350 J.M. Murray Center Inc. ALUMINUM CHLOROHYDRATE 5.67 g/56.7g 55878-101_f6f260e0-3085-4d89-8709-27656c643b41 55878-101 HUMAN OTC DRUG ACNE TREATMENT SERUM BENZOYL PEROXIDE GEL TOPICAL 20130207 OTC MONOGRAPH FINAL part333D Halogent, LLC (DBA Exposed Skin Care) BENZOYL PEROXIDE 3.5 g/100mL 55878-102_901daf24-fae9-4f3f-bb9f-7a7e65af2af9 55878-102 HUMAN OTC DRUG CLARIFYING MASK SULFUR RESORCINOL PASTE TOPICAL 20130207 OTC MONOGRAPH FINAL part333D Halogent, LLC (DBA Exposed Skin Care) RESORCINOL; SULFUR 2; 3 g/100mL; g/100mL 55878-103_1355feda-1a95-40a3-9c26-1bafb1939f35 55878-103 HUMAN OTC DRUG CLEAR PORE SERUM SALICYLIC ACID GEL TOPICAL 20130207 OTC MONOGRAPH FINAL part333D Halogent, LLC (DBA Exposed Skin Care) SALICYLIC ACID 1 g/100mL 55878-104_550de9bb-a6c4-4e1b-9bdf-b0aff71963e0 55878-104 HUMAN OTC DRUG CLEARING TONIC SALICYLIC ACID LIQUID TOPICAL 20130207 OTC MONOGRAPH FINAL part333D Halogent, LLC (DBA Exposed Skin Care) SALICYLIC ACID 1 g/100mL 55878-105_2dfe05ea-f794-448c-9a9e-a0645b9765b5 55878-105 HUMAN OTC DRUG FACIAL CLEANSER SALICYLIC ACID GEL TOPICAL 20130207 OTC MONOGRAPH FINAL part333D Halogent, LLC (DBA Exposed Skin Care) SALICYLIC ACID .5 g/100mL 55878-106_81d6b25e-ac30-46cb-a7e7-a3ea7d1d7d7a 55878-106 HUMAN OTC DRUG CLARIFYING MASK SULFUR, RESORCINOL PASTE TOPICAL 20130207 OTC MONOGRAPH FINAL part333D Halogent, LLC (DBA Exposed Skin Care) RESORCINOL; SULFUR 2; 3 g/100mL; g/100mL 55882-6011_5b99b0e3-25c0-415c-9bd1-36532d3634e9 55882-6011 HUMAN OTC DRUG Hello Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130304 OTC MONOGRAPH FINAL part355 Hello Products LLC SODIUM FLUORIDE 1.5 mg/g 55882-6012_5b99b0e3-25c0-415c-9bd1-36532d3634e9 55882-6012 HUMAN OTC DRUG Hello Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130304 OTC MONOGRAPH FINAL part355 Hello Products LLC SODIUM FLUORIDE 1.5 mg/g 55882-6013_5b99b0e3-25c0-415c-9bd1-36532d3634e9 55882-6013 HUMAN OTC DRUG Hello Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130304 OTC MONOGRAPH FINAL part355 Hello Products LLC SODIUM FLUORIDE 1.5 mg/g 55882-6014_5b99b0e3-25c0-415c-9bd1-36532d3634e9 55882-6014 HUMAN OTC DRUG Hello Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130304 OTC MONOGRAPH FINAL part355 Hello Products LLC SODIUM FLUORIDE 1.5 mg/g 55885-010_b5134f32-b069-4536-a59f-f2627a549933 55885-010 HUMAN OTC DRUG THE QUEEN ROSE WITCH HAZEL LIQUID TOPICAL 20121201 OTC MONOGRAPH FINAL part347 LaLa Co., Ltd. WITCH HAZEL .005 mg/5mL 55891-001_e69c5dfb-6e58-471e-a29d-e6136bbddfff 55891-001 HUMAN OTC DRUG flawless by Sonya aloe BB creme NUDE SPF 20 Sunscreen TITANIUM DIOXIDE CREAM TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part352 Forever Living Products TITANIUM DIOXIDE 7 g/100g 55891-002_f195a273-449e-44e4-a6e1-26db7d88d440 55891-002 HUMAN OTC DRUG flawless by Sonya aloe BB creme COCOA SPF 10 Sunscreen TITANIUM DIOXIDE CREAM TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part352 Forever Living Products TITANIUM DIOXIDE 3 g/100g 55910-001_bb11ab6b-8544-42e9-8362-3f55f6789e26 55910-001 HUMAN OTC DRUG First Aid Antiseptic POVIDONE-IODINE SOLUTION TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E Dolgencorp LLC POVIDONE-IODINE 10 mg/mL 55910-002_d6ad5ea6-4228-424b-bd3a-edeb0c72e2c7 55910-002 HUMAN OTC DRUG rexall enema Saline ENEMA RECTAL 20100813 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, LLC SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 55910-003_eee59738-f1c6-4800-96cb-2caae5378e4f 55910-003 HUMAN OTC DRUG Poly Antibiotic bacitracin zinc, polymyxin B sulfate OINTMENT TOPICAL 20101122 OTC MONOGRAPH FINAL part333B DOLGENCORP, LLC BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g 55910-004_e8dc15b5-a9c6-4171-901c-b6607ff8f5ee 55910-004 HUMAN OTC DRUG Antacid Antigas Aluminum Hydroxide, MAGNESIUM HYDROXIDE, Dimethicone SUSPENSION ORAL 20090107 OTC MONOGRAPH FINAL part331 Dollar General ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 55910-005_55dc7134-1ed2-4bd0-b4da-2c4e51361a3d 55910-005 HUMAN OTC DRUG DG Health Sterile Advanced Relief Eye Dextran 70 SOLUTION/ DROPS OPHTHALMIC 20130630 OTC MONOGRAPH FINAL part349 Dolgencorp Inc DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .001; .01; .01; .0005 mg/mg; mg/mg; mg/mg; mg/mg 55910-006_9c97d295-f00c-474a-bff5-9f5bb8aeb9db 55910-006 HUMAN OTC DRUG DG HEALTH MAXIMUM REDNESS RELIEF GLYCERIN, NAPHAZOLINE HCL SOLUTION/ DROPS OPHTHALMIC 20141124 OTC MONOGRAPH FINAL part349 DOLGENCORP INC GLYCERIN; NAPHAZOLINE HYDROCHLORIDE .0025; .00012 mg/mL; mg/mL 55910-007_c2cb5a0b-af99-4cbd-81fa-ae68daf245bc 55910-007 HUMAN OTC DRUG Athletes Foot Tolnaftate SPRAY TOPICAL 20141104 OTC MONOGRAPH FINAL part333C DOLGENCORP, LLC. TOLNAFTATE 1 g/100g 55910-013_ea06a98a-957b-4b4b-b6ec-35f331e215f6 55910-013 HUMAN OTC DRUG Mucus Relief Severe Cough and Congestion dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride SOLUTION ORAL 20120214 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL 55910-014_94944f39-bb69-46c3-9a27-501737cbbda3 55910-014 HUMAN OTC DRUG DG Health cold multi symptom nite time Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20091005 OTC MONOGRAPH FINAL part341 Dolgencorp Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 55910-017_a7252058-02bf-44b6-8747-14be2719aff8 55910-017 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin-b sulfate OINTMENT TOPICAL 20061107 OTC MONOGRAPH FINAL part333B DOLGENCORP, LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 55910-018_2396bc6c-9e12-48b3-be22-9b7453bfb48b 55910-018 HUMAN OTC DRUG Tussin DM Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20090217 OTC MONOGRAPH FINAL part341 Dollar General DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 55910-020_6f769e1d-4ebf-4d08-89b6-8fcc58575c3e 55910-020 HUMAN OTC DRUG Diaper Rash Zinc oxide PASTE TOPICAL 20120510 OTC MONOGRAPH FINAL part347 DOLGENCORP, LLC ZINC OXIDE 532 mg/g 55910-022_81135dbc-fc99-45dc-8eae-9f2782e7b704 55910-022 HUMAN OTC DRUG DG Health Heartburn Relief Cimetidine TABLET ORAL 20100302 ANDA ANDA075285 Dolgencorp, LLC CIMETIDINE 200 mg/1 55910-024_8f80e218-89e6-4561-a883-35f9b2513a26 55910-024 HUMAN OTC DRUG Peptic Relief Maximum Strength BISMUTH SUBSALICYLATE SUSPENSION ORAL 20090806 OTC MONOGRAPH FINAL part341 Dollar General BISMUTH SUBSALICYLATE 525 mg/15mL 55910-025_76612a29-7288-4be2-afdf-a0828e30ce51 55910-025 HUMAN OTC DRUG CHILDRENS ALLERGY Diphenhydramine Hydrochloride LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part341 Dollar General DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 55910-026_7b328157-a374-416a-b102-07a092a22ac6 55910-026 HUMAN OTC DRUG Rexall Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130807 ANDA ANDA072096 Dolgencorp, LLC IBUPROFEN 200 mg/1 55910-033_80a3ed10-2d6b-4534-bf90-80a06e7c3e4e 55910-033 HUMAN OTC DRUG Mucus Relief Cold and Sinus Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL 55910-034_cd89f2b8-d515-4048-ae91-639fa426bf99 55910-034 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20100629 OTC MONOGRAPH FINAL part333D Dolgencorp, LLC SALICYLIC ACID 19.8 mg/g 55910-035_a20cb168-df7b-4d0e-b963-75ae97418e3a 55910-035 HUMAN OTC DRUG Day Time Cold Multi-Symptom Severe Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED ORAL 20050804 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 55910-037_f1726ceb-feeb-4a6c-8216-b7f8cc315517 55910-037 HUMAN OTC DRUG Fast Acting Mucus Relief Maximum Strength Severe Cough and Congestion dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL 55910-038_2cea94a8-a4da-4d51-98ec-03138db6e8d5 55910-038 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 19931021 OTC MONOGRAPH FINAL part334 DOLGENCORP, LLC MAGNESIUM SULFATE 1 g/g 55910-041_991ba185-e562-40bc-8017-e674164a9a2b 55910-041 HUMAN OTC DRUG DG Health cold and flu relief acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20091003 OTC MONOGRAPH FINAL part341 Dolgencorp Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 55910-042_c5e92567-cbc0-4619-93ff-5168fe7e9e0f 55910-042 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131120 OTC MONOGRAPH FINAL part347 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DIMETHICONE 125 mg/1 55910-045_d1e2729c-8216-44f0-b690-cbf71aa17f40 55910-045 HUMAN OTC DRUG NiteTime Cold plus Flu Releif Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20141030 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 55910-047_bad2d3f7-d58c-480e-8935-b9e86683847a 55910-047 HUMAN OTC DRUG DG Health Acid Reducer Maximum Strength Ranitidine TABLET ORAL 20100206 ANDA ANDA078653 Dolgencorp Inc RANITIDINE HYDROCHLORIDE 150 mg/1 55910-050_bdbedfdb-733d-47ef-84b1-29707487d899 55910-050 HUMAN OTC DRUG dg health Ibuprofen pm diphenhydramine citrate and ibuprofen TABLET, COATED ORAL 20100124 ANDA ANDA079113 Dolgencorp Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 55910-055_c488da1a-ffeb-4376-9f51-990e0905b656 55910-055 HUMAN OTC DRUG DG Body Travel Pack Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Dolgencorp, LLC BENZALKONIUM CHLORIDE .115 g/1 55910-056_b7fbc9f1-c815-4f8b-bc57-ef7df25fd4a0 55910-056 HUMAN OTC DRUG Antacid Supreme Cherry ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE SUSPENSION ORAL 20090107 OTC MONOGRAPH FINAL part331 Dollar General ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE 400; 135 mg/5mL; mg/5mL 55910-057_78f524ac-3498-480d-8979-653c8a5c5674 55910-057 HUMAN OTC DRUG Health Sense Infants Ibuprofen Oral Suspension ibuprofen SUSPENSION ORAL 20090608 ANDA ANDA075217 Dolgencorp Inc IBUPROFEN 50 mg/1.25mL 55910-061_821b5fff-496b-48c6-9a9d-7816742885cf 55910-061 HUMAN OTC DRUG DG Health Antibiotic Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20110114 OTC MONOGRAPH FINAL part333B Dolgencorp Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 55910-063_1f827d06-0da9-4486-97e1-47ba3738ef1f 55910-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 20090413 OTC MONOGRAPH FINAL part346 Dolgencorp, LLC FERRIC OXIDE RED; ZINC OXIDE .8; .8 kg/100L; kg/100L 55910-067_9ecd0226-feba-41ab-bceb-a4cf1ebfa027 55910-067 HUMAN OTC DRUG DG Health Triple Antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20100207 OTC MONOGRAPH FINAL part333 Dolgencorp Inc BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 55910-068_51bd4feb-22e2-4d47-9956-0b6cbf836f26 55910-068 HUMAN OTC DRUG TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sulfate OINTMENT TOPICAL 20030101 OTC MONOGRAPH FINAL part333B DOLGENCORP, LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 55910-069_e8289509-1609-4154-8cd1-fc1332d62e59 55910-069 HUMAN OTC DRUG Pure petroleum White Petrolatum JELLY TOPICAL 19981115 OTC MONOGRAPH FINAL part347 Dolgencorp LLC PETROLATUM 1 g/g 55910-072_a43d2d06-b5f3-44d8-8d6e-dafb4807de0b 55910-072 HUMAN OTC DRUG Night Time Cherry DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, LIQUID ORAL 20090217 OTC MONOGRAPH FINAL part341 Dollar General DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 135 mg/15mL; mg/5mL 55910-074_43f9fa7b-9f68-49a7-b7cc-99a61dc22156 55910-074 HUMAN OTC DRUG DG Health Ibuprofen Ibuprofen TABLET, COATED ORAL 20100201 ANDA ANDA077349 Dolgencorp, LLC IBUPROFEN 200 mg/1 55910-075_bebd296e-1e98-43cc-9bdd-b01e8a9d3717 55910-075 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141130 NDA NDA021920 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) NAPROXEN SODIUM 220 mg/1 55910-078_d5bacc0d-3b50-4d05-8c65-6da2e1cadb82 55910-078 HUMAN OTC DRUG Milk of Magnesia Original MAGNESIUM HYDROXIDE SUSPENSION ORAL 20090323 OTC MONOGRAPH FINAL part334 Dollar General MAGNESIUM HYDROXIDE 1200 mg/15mL 55910-081_d84aa78d-b408-4d51-a54c-c66f6cef33f1 55910-081 HUMAN OTC DRUG dg health miconazole 3 Miconazole nitrate KIT 20100222 ANDA ANDA075329 Dolgencorp Inc 55910-094_3deabbf5-fe4f-4659-859b-3bb1a4ab70dd 55910-094 HUMAN OTC DRUG DG Health nasal decongestant pe maximum strength Phenylephrine Hydrochloride TABLET ORAL 20100129 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 55910-096_a0410a93-7278-4b97-bf9b-471d36b2223d 55910-096 HUMAN OTC DRUG dg health flu and severe cold and cough Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20110524 OTC MONOGRAPH FINAL part341 Dolgencorp Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 55910-100_8b3fa437-f27c-4ab9-bbad-209069950861 55910-100 HUMAN OTC DRUG Tussin Sugar Free Cough Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20080924 OTC MONOGRAPH FINAL part341 Dollar General DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 55910-103_0a5f3384-b1b7-4005-9f09-27410d7bda2c 55910-103 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20090217 OTC MONOGRAPH FINAL part341 Dollar General ACETAMINOPHEN 160 mg/5mL 55910-105_48a44ba0-4775-44ae-8fb0-ffdc244629bc 55910-105 HUMAN OTC DRUG Rexall Medicated WipesHemorrhoidal wipe Hemorrhoidal wipes with witch hazel witch hazel CLOTH TOPICAL 20120101 OTC MONOGRAPH FINAL part346 Dolgencorp, LLC WITCH HAZEL 129 g/258g 55910-110_180667e6-82d8-4fc1-b91e-3687ae017098 55910-110 HUMAN OTC DRUG Rexall Feminine Povidone-iodine KIT 20101019 OTC MONOGRAPH NOT FINAL part333A Dolgencorp Inc 55910-112_40976000-d8d3-4c98-a3df-10e525dc8088 55910-112 HUMAN OTC DRUG Night Time Original Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20051108 OTC MONOGRAPH FINAL part341 Dollar General ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 55910-113_43f1daaa-3624-4828-8abd-0601421f825f 55910-113 HUMAN OTC DRUG Night Time Cherry Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, LIQUID ORAL 20051108 OTC MONOGRAPH FINAL part341 Dollar General ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 55910-117_16a9ce16-97cf-4c08-bbeb-6a48f7c17d87 55910-117 HUMAN OTC DRUG dg health lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120521 ANDA ANDA202319 Dolgencorp, LLC LANSOPRAZOLE 15 mg/1 55910-120_32a29b79-d7ad-45b3-8803-d2be28ceaa3d 55910-120 HUMAN OTC DRUG womans laxative Bisacodyl TABLET, COATED ORAL 20130621 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) BISACODYL 5 mg/1 55910-121_a451f9b9-7498-4243-a49c-dbcff6ef9875 55910-121 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120517 ANDA ANDA078682 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) IBUPROFEN 200 mg/1 55910-129_5d367c47-ce34-41fa-a362-ea7eef0b43f9 55910-129 HUMAN OTC DRUG Allergy Relief All Day Cetirizine HCl TABLET ORAL 20130517 ANDA ANDA078780 Dolgencorp, Inc. 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(DOLLAR GENERAL & REXALL) SENNOSIDES 25 mg/1 55910-141_c7b83cba-082f-407a-8bb1-30685ffb9a87 55910-141 HUMAN OTC DRUG dg health heartburn prevention original strength Famotidine TABLET ORAL 20100310 ANDA ANDA075400 Dolgencorp, LLC FAMOTIDINE 10 mg/1 55910-143_75cb20a9-b957-4ccd-8a63-a20ddab8e86d 55910-143 HUMAN OTC DRUG DG Health Mucus Relief Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130726 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 55910-145_9c2e7794-6a3b-466c-9a38-1efd3765b048 55910-145 HUMAN OTC DRUG Childrens Plus Multi-Symptom Cold Grape with PE ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE SUSPENSION ORAL 20090729 OTC MONOGRAPH FINAL part341 Dollar General ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 55910-148_f12aaa78-0b09-43bd-8def-f07ef553886f 55910-148 HUMAN OTC DRUG Diaper Rash Zinc oxide CREAM TOPICAL 20110729 OTC MONOGRAPH NOT FINAL part347 DolGenCorp, LLC ZINC OXIDE .113 kg/g 55910-150_05fc45d5-5a75-4534-91b5-78b5bf71e4d9 55910-150 HUMAN OTC DRUG Stool Softener Maximum Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130430 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. 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(DOLLAR GENERAL & REXALL) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 55910-245_884789fa-b195-4301-aba6-39272ed61339 55910-245 HUMAN OTC DRUG Laxative pills Maximum Strength Sennosides TABLET ORAL 20131230 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) SENNOSIDES 25 mg/1 55910-246_6f2f7b7f-d98f-42a3-ba19-e7a9f4ab8ed7 55910-246 HUMAN OTC DRUG Medicated Dandruff Selenium sulfide SHAMPOO TOPICAL 20111103 OTC MONOGRAPH FINAL part358H Dolgencorp.LLC SELENIUM SULFIDE 1 kg/100L 55910-247_9dc94f84-488d-4e6e-a3cb-af77f588ad6b 55910-247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140131 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, Inc. 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(DOLLAR GENERAL & REXALL) DOCUSATE SODIUM 250 mg/1 55910-271_6bc6200c-990d-412c-b241-a3a4df3b61f7 55910-271 HUMAN OTC DRUG dg health acid reducer Ranitidine TABLET ORAL 20100327 ANDA ANDA076760 Dolgencorp Inc RANITIDINE HYDROCHLORIDE 75 mg/1 55910-274_4c2e2c79-8c9d-4a9c-b7ef-412aa19834fb 55910-274 HUMAN OTC DRUG rexall aspirin Aspirin TABLET, CHEWABLE ORAL 20100819 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ASPIRIN 81 mg/1 55910-279_0415c51b-5a12-49d4-8968-0131ddb85545 55910-279 HUMAN OTC DRUG rexall hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140828 OTC MONOGRAPH FINAL part346 Dolgencorp Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 55910-289_b4030eb4-b69c-42d3-abe4-8baa63738f52 55910-289 HUMAN OTC DRUG DG Health Pain Relief Infants Acetaminophen SUSPENSION/ DROPS ORAL 20100124 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 80 mg/.8mL 55910-291_d085995d-dedc-46cc-a32f-2020816cf5da 55910-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC IBUPROFEN 200 mg/1 55910-294_0ff7ddfc-489b-46f7-a457-aa348dfa1bf2 55910-294 HUMAN OTC DRUG DG BODY ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC. TRICLOSAN .15 mL/100mL 55910-294_e09edddf-1b0b-45cc-88e9-4016fc85318f 55910-294 HUMAN OTC DRUG DG BODY ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC. TRICLOSAN .15 mL/100mL 55910-295_ebed9ac6-5ace-4b4c-9aa4-50f609565db0 55910-295 HUMAN OTC DRUG Itch Relief Diphenhydramine HCl, Zinc Acetate SPRAY TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part348 DOLGENCORP, LLC DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 18; 882 mg/mL; mg/mL 55910-296_546712dc-832a-4924-b35a-552d0a8008a5 55910-296 HUMAN OTC DRUG DG BODY ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC. TRICLOSAN .15 mL/100mL 55910-296_f1098463-11da-43b4-8c48-da246cfad9ad 55910-296 HUMAN OTC DRUG DG BODY ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120504 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC. TRICLOSAN .15 mL/100mL 55910-299_25b2ad45-150b-47b5-bfc6-753cebb83a11 55910-299 HUMAN OTC DRUG Health Cetylpyridinium chloride MOUTHWASH ORAL 20080721 OTC MONOGRAPH NOT FINAL part356 DOLGENCORP, LLC CETYLPYRIDINIUM CHLORIDE .7 mg/mL 55910-300_8cb15a8d-c836-4167-bc6b-dd20a34076e8 55910-300 HUMAN OTC DRUG DG Health Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140327 OTC MONOGRAPH FINAL part341 Dolgencorp Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 55910-301_d9108290-ebb9-455b-add3-78489380978a 55910-301 HUMAN OTC DRUG Dollar General Gold Triclocarban SOAP TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Dolgencorp, LLC TRICLOCARBAN .6 g/100g 55910-302_b18ebada-2b1e-4c25-833a-190a9b889fe5 55910-302 HUMAN OTC DRUG DG health childrens pain relief Acetaminophen SUSPENSION ORAL 20120909 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 160 mg/5mL 55910-304_91e207b3-82bf-42e6-8f70-57f0666d39df 55910-304 HUMAN OTC DRUG dg health nasal original oxymetazoline hydrochloride SPRAY NASAL 20100108 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 55910-305_7b2d8194-b5b3-4b12-a38d-21482878a3fc 55910-305 HUMAN OTC DRUG DG HEALTH ANTI ITCH DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20110517 OTC MONOGRAPH FINAL part336 DOLGENCORP, INC. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 55910-306_60a79aa7-6528-4c2e-95dc-da72b476d53e 55910-306 HUMAN OTC DRUG dg health clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 Dolgencorp, LLC POLYETHYLENE GLYCOL 3350 17 g/17g 55910-308_a62a92eb-090b-42eb-812c-00d5c36cfd2f 55910-308 HUMAN OTC DRUG DG Health cold multi symptom severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20091128 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 55910-311_0cbb6d50-c73b-4077-bbbe-a0b504f28e0c 55910-311 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20050623 OTC MONOGRAPH FINAL part358H Dolgencorp, LLC PYRITHIONE ZINC 1 kg/100L 55910-314_0fa25ed9-5800-416a-81f6-3cf6bc3904be 55910-314 HUMAN OTC DRUG Extra Strength Back and Body Aspirin, Caffeine CAPSULE ORAL 20040412 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ASPIRIN; CAFFEINE 500; 32.5 mg/1; mg/1 55910-318_ae26ec1d-4ab0-498f-b636-079cdcf6bdf1 55910-318 HUMAN OTC DRUG Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20010111 OTC MONOGRAPH NOT FINAL part356 DOLGENCORP,LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 55910-319_2cc792b8-dce6-4178-bd6d-63ba268b7747 55910-319 HUMAN OTC DRUG DG Health Hydrocortisone Cream Maximum Strength Hydrocortisone CREAM TOPICAL 20100130 OTC MONOGRAPH NOT FINAL part348 Dolgencorp Inc HYDROCORTISONE 1 g/100g 55910-320_05ba2419-a27d-477a-9da5-5538347ed41f 55910-320 HUMAN OTC DRUG Dollar General Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Dolgencorp LLC POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 55910-321_03c594d0-c318-456b-acbd-90d7560f34be 55910-321 HUMAN OTC DRUG DG Health Dual Action Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20090716 ANDA ANDA077355 Dolgencorp Inc CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 55910-322_68d35ef6-1c86-4873-a863-7ad7557548f2 55910-322 HUMAN OTC DRUG Dollar General Toothache Relief Benzocaine PASTE, DENTIFRICE TOPICAL 20110120 OTC MONOGRAPH FINAL part333B Dollar General BENZOCAINE 20 g/100g 55910-325_47017d6b-a941-480c-832a-da3b2d58b651 55910-325 HUMAN OTC DRUG Extra Strength PM Pain Relief Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55910-326_44ff5186-3c4e-400c-be42-2f89d78d7654 55910-326 HUMAN OTC DRUG Daily Facial Moisturizer Broad Spectrum SPF15 Sunscreen Avobenzone, Octocrylene CREAM TOPICAL 20130720 OTC MONOGRAPH NOT FINAL part352 Dolgencorp Inc. AVOBENZONE; OCTOCRYLENE 3; 10 g/100mL; g/100mL 55910-327_61002503-ae28-45cd-a914-f28f1e011dc1 55910-327 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 DOLGENCORP, LLC BISACODYL 5 mg/1 55910-328_0a5c79f8-875d-44f7-9016-9225959ff3ac 55910-328 HUMAN OTC DRUG dg health sore throat Phenol SPRAY ORAL 20100117 OTC MONOGRAPH NOT FINAL part356 Dolgencorp, LLC PHENOL 1.4 g/100mL 55910-329_ed14be3e-1f64-4df1-92cd-798a9ab2c5b6 55910-329 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55910-333_38433e43-3cb3-4e43-a1d1-b0da2cf463db 55910-333 HUMAN OTC DRUG Ultimate Daily Face Wash Salicylic Acid CREAM TOPICAL 20130720 OTC MONOGRAPH FINAL part333D Dolgencorp Inc. SALICYLIC ACID 2 g/100mL 55910-335_15aae484-4942-4912-a3d7-9b231c6391d4 55910-335 HUMAN OTC DRUG dg health night time cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110817 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 55910-337_d1f140a3-44d9-4a08-8a71-03519f93fe18 55910-337 HUMAN OTC DRUG rexall bismuth Bismuth subsalicylate LIQUID ORAL 20120906 OTC MONOGRAPH FINAL part335 Dolgencorp, LLC BISMUTH SUBSALICYLATE 1050 mg/30mL 55910-348_f55b9216-9cee-4b4d-ad42-b62fd0200ebc 55910-348 HUMAN OTC DRUG Maximum Strength Laxative Sennosides TABLET ORAL 20030104 OTC MONOGRAPH NOT FINAL part334 DOLGENCORP, LLC SENNOSIDES A AND B 25 mg/1 55910-355_288dcda2-42b2-42cd-bbc7-ec77e16a6095 55910-355 HUMAN OTC DRUG dg health headache relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20100214 OTC MONOGRAPH FINAL part338 Dolgencorp, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55910-356_2621ef2a-e7aa-4e2a-9dba-7af200305f2d 55910-356 HUMAN OTC DRUG Antacid Supreme Cherry ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE SUSPENSION ORAL 20100315 OTC MONOGRAPH FINAL part331 Dollar General ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE 400; 135 mg/5mL; mg/5mL 55910-357_0acc0808-35d7-44b0-b293-82d274a1cf9c 55910-357 HUMAN OTC DRUG dg health antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20140509 OTC MONOGRAPH FINAL part331 Dolgencorp, LLC ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 55910-359_6bbd5f1e-170e-4e2b-a840-6d9204f476cb 55910-359 HUMAN OTC DRUG dg health tussin dm adult Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20100222 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 55910-367_14f969b2-9c78-441e-9721-c1afccc2b665 55910-367 HUMAN OTC DRUG Nite Aid Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 DOLGENCORP, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55910-368_015c85ae-db15-426d-b08b-6cd72ce4cb07 55910-368 HUMAN OTC DRUG dg health all day pain relief Naproxen Sodium TABLET, FILM COATED ORAL 20100117 ANDA ANDA074661 Dolgencorp Inc NAPROXEN SODIUM 220 mg/1 55910-369_1fcd19dc-3d81-4f2d-bddd-76ff5533d597 55910-369 HUMAN OTC DRUG Menstrual Pain Relief Acetaminophen, Pamabrom and Pyrilamine maleate TABLET, FILM COATED ORAL 20000620 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 55910-370_97c58fb9-e476-4637-b851-33363ea3b51c 55910-370 HUMAN OTC DRUG dg health mucus relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140724 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 55910-371_6a21cbc8-6a50-4f7a-a25c-9e1e6e2d25bd 55910-371 HUMAN OTC DRUG rexall all day pain relief Naproxen Sodium TABLET, FILM COATED ORAL 20120928 ANDA ANDA074661 Dolgencorp Inc NAPROXEN SODIUM 220 mg/1 55910-373_316ddccf-41d4-4188-ae8c-c314986475a2 55910-373 HUMAN OTC DRUG Headache Relief PM Acetaminophen and Diphenhydramine Citrate TABLET ORAL 20040607 OTC MONOGRAPH FINAL part338 DOLGENCORP, LLC ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 55910-374_ff2d64ac-e7c9-470c-8f72-e7fbe1502983 55910-374 HUMAN OTC DRUG DG Health migraine relief Acetaminophen, Aspirin, Caffeine TABLET, COATED ORAL 20091204 ANDA ANDA075794 Dolgencorp, LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 55910-377_93c7ccf0-ad2c-45b1-b7b6-07d58712970c 55910-377 HUMAN OTC DRUG rexall anti diarrheal Loperamide HCl SOLUTION ORAL 20100809 ANDA ANDA073243 Dolgencorp, LLC LOPERAMIDE HYDROCHLORIDE 1 mg/5mL 55910-378_c0a3da01-b4ec-456c-a558-145ef90e954c 55910-378 HUMAN OTC DRUG Triacting Daytime Cold Cough Childrens Dextromethorphan HBr, Phenylephrine HCl SYRUP ORAL 20140530 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 55910-379_3a99a551-3b98-45e0-884e-1f50d91c6949 55910-379 HUMAN OTC DRUG dg health allergy childrens Diphenhydramine Hydrochloride LIQUID ORAL 20100129 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 55910-381_920d9b7d-2bc3-4a64-a4d2-766d5f2867ca 55910-381 HUMAN OTC DRUG DG Health Mucus Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130726 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 55910-384_648ca6b2-d31f-4941-baad-0f2accd30a9e 55910-384 HUMAN OTC DRUG DG Health Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130702 ANDA ANDA091135 Dolgencorp, LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 55910-388_7fd88550-81f3-4c6d-b6c0-806d2ebb3f4f 55910-388 HUMAN OTC DRUG DG Health Antacid Calcium Supplement Calcium carbonate TABLET, CHEWABLE ORAL 20131210 OTC MONOGRAPH FINAL part331 Dolgencorp, LLC CALCIUM CARBONATE 750 mg/1 55910-390_5e991447-b085-4c19-a982-f899638d2db7 55910-390 HUMAN OTC DRUG Maximum Strength Menstrual Relief Acetaminophen, Caffeine and Pyrilamine maleate CAPSULE ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 55910-391_784b4164-3b17-4e56-bb4e-e872c5fde188 55910-391 HUMAN OTC DRUG DG HEALTH EXTRA STRENGTH MEDICATED MENTHOL PATCH TOPICAL 20121231 OTC MONOGRAPH NOT FINAL part348 DOLGENCORP INC MENTHOL 750 mg/1 55910-392_4a0deb5d-8961-c8c8-2274-eb622422f259 55910-392 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990302 ANDA ANDA075139 DOLGENCORP, LLC IBUPROFEN 200 mg/1 55910-393_41d1917e-1979-4551-a1ec-55a72ac20a94 55910-393 HUMAN OTC DRUG DG Health Cold Head Congestion Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20100222 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 55910-394_ed78930c-d910-4d07-a88d-de1071d718b6 55910-394 HUMAN OTC DRUG rexall hemorrhoidal Cocoa butter, Phenylephrine HCl, Shark liver oil SUPPOSITORY RECTAL 20110524 OTC MONOGRAPH FINAL part346 Dolgencorp, LLC COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2137.5; 75; 6.375 mg/1; mg/1; mg/1 55910-395_43f28ef0-4e29-4e7b-83c5-607371391fa5 55910-395 HUMAN OTC DRUG DG Health Extra Strength Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Dolgencorp Inc MENTHOL 750 mg/1 55910-396_46b11c95-4438-47af-93ab-8b477c88ceb9 55910-396 HUMAN OTC DRUG dg health milk of magnesia Magnesium hydroxide SUSPENSION ORAL 20140507 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, LLC MAGNESIUM HYDROXIDE 1200 mg/15mL 55910-397_0fa38747-74a1-419f-bdfc-311b2bb81fb2 55910-397 HUMAN OTC DRUG dg health antacid calcium supplement regular strength calcium carbonate TABLET, CHEWABLE ORAL 20091121 OTC MONOGRAPH FINAL part331 Dolgencorp Inc CALCIUM CARBONATE 500 mg/1 55910-400_1e9a2c03-b7ae-4277-9341-5ee2b2f75a35 55910-400 HUMAN OTC DRUG DG Health Hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 20100522 OTC MONOGRAPH FINAL part346 Dolgencorp, LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 55910-401_888afc3f-7807-4817-9cbc-bd963a2ecd8a 55910-401 HUMAN OTC DRUG Rexall Childrens Allergy Diphenhydramine HCl LIQUID ORAL 20130726 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 55910-402_600fd5a6-bacf-4d4d-b6da-8a1bdca490c0 55910-402 HUMAN OTC DRUG Rexall Maximum Strength Hemorrhoidal PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM CREAM TOPICAL 20110628 OTC MONOGRAPH FINAL part346 Dolgencorp, Inc. GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 144; 150; 2.5; 10 mg/g; mg/g; mg/g; mg/g 55910-411_446d3839-405f-4c25-bb23-4a7f669bb20e 55910-411 HUMAN OTC DRUG Cough and Cold Chlorpheniramine maleate TABLET ORAL 20030503 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 55910-413_a292abde-8093-4a3b-8fbc-b3e921973ad5 55910-413 HUMAN OTC DRUG DG Health Ibuprofen PM Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20100817 ANDA ANDA079113 Dolgencorp, LLC DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 55910-414_197ea351-e639-44e6-ac50-8f36e800c0bb 55910-414 HUMAN OTC DRUG Adult Low Strength Aspirin Aspirin TABLET, COATED ORAL 20040114 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ASPIRIN 81 mg/1 55910-418_70433ad1-a174-4b7e-9e20-258f8aa278b5 55910-418 HUMAN OTC DRUG Skin Corrective BB Cream Broad Spectrum SPF15 Sunscreen Titanium Dioxide, Octinoxate CREAM TOPICAL 20130720 OTC MONOGRAPH NOT FINAL part352 Dolgencorp Inc. OCTINOXATE; TITANIUM DIOXIDE 4; 2.1 g/100mL; g/100mL 55910-419_f3d049a2-821d-431d-ac05-bed1620f15f1 55910-419 HUMAN OTC DRUG DG Health Childrens Mucus Relief Cough Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20091114 OTC MONOGRAPH FINAL part341 Dolgencorp Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 55910-428_82934a26-cc9d-4f87-b65f-4bb5f1bce79a 55910-428 HUMAN OTC DRUG DG Health Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20100117 OTC MONOGRAPH FINAL part332 Dolgencorp, LLC DIMETHICONE 125 mg/1 55910-430_f49d3755-bb1b-4b79-baa5-52ad16b2ea64 55910-430 HUMAN OTC DRUG dg health headache relief added strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20100310 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 55910-431_0f03c102-8ae4-4134-bdf6-62b586ba1e88 55910-431 HUMAN OTC DRUG dg health sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20100124 OTC MONOGRAPH FINAL part338 Dolgencorp Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 55910-437_97756094-05fa-41d5-8834-27e340f0880f 55910-437 HUMAN OTC DRUG dg health pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20091121 OTC MONOGRAPH FINAL part338 Dolgencorp, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 55910-438_90b19eb1-8b59-4b6e-8fbd-4a2c065380d8 55910-438 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20040414 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ASPIRIN 81 mg/1 55910-439_529f5c9b-16d0-4461-b39b-07e9ec327589 55910-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130222 OTC MONOGRAPH NOT FINAL part333A DOLGENCORP, LLC ALCOHOL 700 mg/mL 55910-444_e30d83bc-2b3f-47a5-9d0f-46b3758a1777 55910-444 HUMAN OTC DRUG DG Health Triacting Childrens Dextromethorphan HBr, Phenylephrine HCl SYRUP ORAL 20091114 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 55910-445_6a04da66-be14-4028-97eb-1c7d2d0380d3 55910-445 HUMAN OTC DRUG dg health flu and severe cold and cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20140315 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; 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SELENIUM SULFIDE 1 mL/100mL 55910-620_6263e323-b76e-4e9e-97a3-6dfd08fd20d4 55910-620 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET ORAL 20121003 OTC MONOGRAPH FINAL part336 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) MECLIZINE HYDROCHLORIDE 25 mg/1 55910-621_ffa7c42d-5a7b-45d9-b2a9-a2980ef990b9 55910-621 HUMAN OTC DRUG REXALL ALOE SELENIUM SULFIDE LIQUID TOPICAL 20130731 OTC MONOGRAPH FINAL part358H DOLGENCORP INC. 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PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL 55910-871_56fc7f03-af33-4143-bc42-38f3e9464b4d 55910-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 19891115 OTC MONOGRAPH NOT FINAL part333A DOLGENCORP, LLC HYDROGEN PEROXIDE .3 kg/100L 55910-872_8240c7a0-f645-4360-9511-10e4f3219eb5 55910-872 HUMAN OTC DRUG rexall night time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120909 OTC MONOGRAPH FINAL part341 Dolgencorp Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 55910-888_b0507c8e-6646-434d-bc43-01a9872f2c40 55910-888 HUMAN OTC DRUG DG Health Pain Relief Acetaminophen CAPSULE, COATED ORAL 20110131 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 500 mg/1 55910-890_3d844f48-4565-49f1-ab01-b599ee07b9c3 55910-890 HUMAN OTC DRUG Cold and Allergy Maximum Strength Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20130430 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 55910-893_c3a30b2e-ba45-4f40-af29-14fb28feec17 55910-893 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20080715 OTC MONOGRAPH FINAL part355 Dolgencorp, LLC SODIUM FLUORIDE .0221 kg/100L 55910-897_a1b1de9e-de2a-4f96-a865-18a1a2c5cd91 55910-897 HUMAN OTC DRUG DG Health Ibuprofen Ibuprofen SUSPENSION ORAL 20100206 ANDA ANDA074937 Dolgencorp Inc IBUPROFEN 100 mg/5mL 55910-902_be8f99cb-89e6-40f2-90d5-21cbcabad0b8 55910-902 HUMAN OTC DRUG rexall ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20120824 ANDA ANDA072096 Dolgencorp Inc IBUPROFEN 200 mg/1 55910-906_0d7da4c3-309f-4327-a036-08da6f7735c4 55910-906 HUMAN OTC DRUG dg health cold and allergy childrens phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20100117 OTC MONOGRAPH FINAL part341 Dolgencorp Inc BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 55910-908_4f629b4d-9eb9-4e4c-8685-e79fc4daf929 55910-908 HUMAN OTC DRUG dg health cold and flu relief nite time acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20091121 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 55910-911_dfcfd1ed-830d-4759-80e1-b1bd38fcfc7a 55910-911 HUMAN OTC DRUG DG Health Pain Relieving Menthol PATCH TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part348 DOLGENCORP INC MENTHOL 750 mg/1 55910-913_ae2555d1-3194-4cb0-99b4-f61c92fa5cb4 55910-913 HUMAN OTC DRUG dg health triacting nite time cold and cough Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20091114 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 55910-915_fef8a4fa-f17c-4dc2-ba86-b12714728782 55910-915 HUMAN OTC DRUG dg health omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20100214 NDA NDA022032 Dolgencorp, LLC OMEPRAZOLE 20 mg/1 55910-917_bd89f242-6432-4391-a092-f5a2a859da25 55910-917 HUMAN OTC DRUG dg health pain reliever Acetaminophen CAPSULE, COATED ORAL 20110131 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 500 mg/1 55910-922_e2b73326-531f-4746-86d8-e6898c3f050d 55910-922 HUMAN OTC DRUG DG Health Fast Acting Mucus Relief Severe Congestion and Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130802 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 55910-932_367751f9-a870-47e3-a267-37b773dcd5a1 55910-932 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20020330 ANDA ANDA075139 DOLGENCORP, LLC IBUPROFEN 200 mg/1 55910-935_e15daf43-67bc-4f4e-8cbe-d9cd5ad3fb62 55910-935 HUMAN OTC DRUG dg health sinus congestion and pain Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20100111 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 55910-946_570d0568-6b3c-4de0-b0ab-01a379adebe6 55910-946 HUMAN OTC DRUG dg health infants pain and fever Acetaminophen SUSPENSION ORAL 20111119 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 160 mg/5mL 55910-947_de793159-e6cc-4ee5-8e1f-ba0d62c11693 55910-947 HUMAN OTC DRUG Acne Wash Salicylic Acid 2% LOTION TOPICAL 20080608 OTC MONOGRAPH FINAL part333D DOLGENCORP, LLC SALICYLIC ACID 20.6 mg/mL 55910-950_d0ba3a1d-8c76-452f-9eeb-e03ef437407b 55910-950 HUMAN OTC DRUG rexall heartburn relief Ranitidine TABLET, FILM COATED ORAL 20111003 ANDA ANDA091429 Dolgencorp, LLC RANITIDINE HYDROCHLORIDE 150 mg/1 55910-951_d22abb2e-6ffa-48ae-af49-1028d619c823 55910-951 HUMAN OTC DRUG Instant Hand sanitizer ALCOHOL GEL TOPICAL 20110429 OTC MONOGRAPH NOT FINAL part333A Dolgencorp, LLC ALCOHOL 65 kg/100L 55910-952_e49e94e3-52d5-4035-9d5c-bb769a40b57a 55910-952 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20130306 OTC MONOGRAPH NOT FINAL part333A DOLGENCORP, INC ALCOHOL 70 mL/100mL 55910-955_f9609746-658c-4d66-8b66-b54eaa57f6c4 55910-955 HUMAN OTC DRUG Allergy Multi-Symptom Acetaminophen, Phenylephrine HCl, Chlorpheniramine maleate CAPSULE, GELATIN COATED ORAL 20080317 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 55910-957_30a1842a-f52b-4d98-9e32-2f3508886e05 55910-957 HUMAN OTC DRUG Rexall Nicotine Nicotine Polacrilex LOZENGE ORAL 20130808 ANDA ANDA203690 Dolgencorp, LLC NICOTINE 4 mg/1 55910-958_949e8907-860e-4f36-a840-d63d2bae3348 55910-958 HUMAN OTC DRUG DG Health Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130710 ANDA ANDA091135 Dolgencorp, LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 55910-964_37d8bd45-03ab-4017-98fe-d3694d706525 55910-964 HUMAN OTC DRUG dg health flu and severe cold and cough Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20110524 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 55910-966_274958b6-304f-4f17-8f1f-a5528412c440 55910-966 HUMAN OTC DRUG Rexall Arthritis Pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130731 ANDA ANDA075077 Dolgencorp, LLC ACETAMINOPHEN 650 mg/1 55910-973_9ce0d271-739c-42de-aa98-7a5c44c0a5f5 55910-973 HUMAN OTC DRUG rexall hydrocortisone plus moisturizers hydrocortisone CREAM TOPICAL 20110114 OTC MONOGRAPH NOT FINAL part348 Dolgencorp, LLC HYDROCORTISONE 1 g/100g 55910-974_2e3499f6-9660-4dc6-8000-b2d790b2397e 55910-974 HUMAN OTC DRUG rexall allergy relief cetirizine hydrochloride LIQUID ORAL 20100807 ANDA ANDA090254 Dolgencorp, LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL 55910-975_c6965f2a-ec9d-4166-93bf-77f2fd84a4af 55910-975 HUMAN OTC DRUG Rexall Pain Relief Acetaminophen TABLET ORAL 20130807 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 500 mg/1 55910-977_2d565b23-7d46-4f7f-88b0-f28b5b34086f 55910-977 HUMAN OTC DRUG dg health cold and flu relief nite time Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20091117 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 55910-988_531e77e0-c06d-4738-a528-78e70ff2d960 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL 55910-988_806f7399-6882-49b2-a590-a39d3fe65422 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL 55910-988_92d20135-bcb1-4691-b072-c829152b5f62 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL 55910-988_973793bf-190b-448d-8c16-9fc05358ca08 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL 55910-988_a05727f7-280d-4864-b4f6-45853f7d3d87 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL 55910-988_a66ada3e-bf6d-4900-bde8-062c2c94cc58 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL 55910-988_a7c0a6bb-b395-46e3-8e44-50d52a699245 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL 55910-988_ac9507ee-18eb-493e-ac1e-6a1d03c24f69 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL 55910-988_bb42a41f-8de0-4067-8c51-6db38444cc17 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL 55910-988_be299127-e993-4304-96f6-ac25fd273077 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL 55910-988_c3405e64-971e-41db-bc95-fcafc38e8715 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL 55910-988_e662ee78-4e1d-4f4c-ba2d-2ed78b57d1e6 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL 55910-990_adf28daa-5b8d-4eae-9b7f-3a42e4c821c6 55910-990 HUMAN OTC DRUG rexall night time cold and flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate LIQUID ORAL 20100810 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 55910-994_54c8b33f-4276-4539-ac85-7e8c05544900 55910-994 HUMAN OTC DRUG dg health cold plus flu relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20091002 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 55918-001_ac036ab4-3bae-41ac-a96a-ee269149ac19 55918-001 HUMAN PRESCRIPTION DRUG Phocal Apf Sodium Fluoride, hydrofluoric acid DISC TOPICAL 20130101 UNAPPROVED DRUG OTHER U.S.I.A. Inc HYDROFLUORIC ACID; SODIUM FLUORIDE .0094; .0466 mg/1; mg/1 55918-002_67102241-92fc-402b-a416-2462f94a2087 55918-002 HUMAN PRESCRIPTION DRUG Phocal pHn Sodium Fluoride DISC TOPICAL 20130101 UNAPPROVED DRUG OTHER U.S.I.A. Inc SODIUM FLUORIDE .055 mg/1 55924-0001_785dc00b-da8c-415c-908f-a7ee6b23997c 55924-0001 HUMAN PRESCRIPTION DRUG Ultra Ambrosia artemisiaefolia, Anacardium orientale, Baryta muriatica, Calcarea carbonica, Calcarea phosphorica, Fucus Vesiculosus, Helleborus niger, Hypothalamus, Ignatia amara, Lycopodium clavatum, Magnesia phosphorica, Manganum metallicum, Nicotinamidum, Phosphorus, Secale Cornutum, Silicea, Solidago virgaurea, Thymus serpyllum, Thyroidinum LIQUID ORAL 20130503 UNAPPROVED HOMEOPATHIC Soza Clinic AMBROSIA ARTEMISIIFOLIA; BARIUM CHLORIDE DIHYDRATE; BOS TAURUS HYPOTHALAMUS; CLAVICEPS PURPUREA SCLEROTIUM; FUCUS VESICULOSUS; HELLEBORUS NIGER ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS IGNATII SEED; THYMUS SERPYLLUM; THYROID, UNSPECIFIED; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 10; 12; 12; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 55924-0002_ba265c18-aacd-4a98-b1f2-e31ae6fee62d 55924-0002 HUMAN PRESCRIPTION DRUG Ultra Pure Adrenalinum, Adrenocorticotrophin, Agrimonia eupatoria, flos, Anacardium orientale, Antimonium crudum, Calcarea carbonica, Castanea sativa, flos, Cortisone aceticum, Fucus vesiculosus, Hypothalamus, Kali bichromicum, Oleander, Pituitarum posterium, Sabadilla, Staphysagria, Thyroidinum LIQUID ORAL 20130528 UNAPPROVED HOMEOPATHIC Soza Clinic AGRIMONIA EUPATORIA FLOWER; ANTIMONY TRISULFIDE; BOS TAURUS HYPOTHALAMUS; CASTANEA SATIVA FLOWER; CORTICOTROPIN; CORTISONE ACETATE; DELPHINIUM STAPHISAGRIA SEED; EPINEPHRINE; FUCUS VESICULOSUS; NERIUM OLEANDER LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; SCHOENOCAULON OFFICINALE SEED; SEMECARPUS ANACARDIUM JUICE; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] 55924-1001_3bf71726-45af-42dd-8172-0441ee180730 55924-1001 HUMAN OTC DRUG ADVANTAGE ABROTANUM, ANACARDIUM ORIENTALE, BARYTA MURIATICA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, FUCUS VESICULOSUS, GRAPHITES LIQUID ORAL 20141215 UNAPPROVED HOMEOPATHIC Soza Clinic ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CHLORIDE DIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; FUCUS VESICULOSUS; GRAPHITE; HELLEBORUS NIGER ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS IGNATII SEED; SUS SCROFA HYPOTHALAMUS; SUS SCROFA THYROID; THYMUS SERPYLLUM; TRIBASIC CALCIUM PHOSPHATE 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55924-2001_4f696521-921a-4fb8-0d0d-7ddd368a6e4a 55924-2001 HUMAN OTC DRUG ULTRA PRO artemisia abrotanum flowering top, semecarpus anacardium juice, barium chloride dihydrate, oyster shell calcium carbonate, crude, tribasic calcium phosphate, fucus vesiculosus, graphite, helleborus niger root, bos taurus hypothalamus, strychnos ignatii seed, lycopodium clavatum spore, magnesium phosphate, dibasic trihydrate, claviceps purpurea sclerotium, silicon dioxide, solidago virgaurea flowering top, thymus serpyllum and thyroid, unspecified LIQUID ORAL 20130301 UNAPPROVED HOMEOPATHIC SENA LLC ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CHLORIDE DIHYDRATE; BOS TAURUS HYPOTHALAMUS; CLAVICEPS PURPUREA SCLEROTIUM; FUCUS VESICULOSUS; GRAPHITE; HELLEBORUS NIGER ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS IGNATII SEED; THYMUS SERPYLLUM; THYROID, UNSPECIFIED; TRIBASIC CALCIUM PHOSPHATE 10; 10; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 10 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 55926-0011_8d7e21c4-e8c5-4d45-ba24-f7a9e0cf593c 55926-0011 HUMAN OTC DRUG Tranquil Remedy No. 11 Adrenalinum, Alfalfa, Ambrosia artemisiaefolia, Anacardium orientale, Argentum nitricum, Avena sativa, Aesculus hippocastanum, flos, Calcarea carbonica, Carboneum oxygenisatum, Carpinus betulus, flos, Citricum acidum, Gelsemium sempervirens, Hypothalamus, Kali phosphoricum, Lecithin, Natrum muriaticum, Olea europaea, flos, Phosphoricum acidum, Pituitarum posterium, Selenium metallicum, Sepia, Silicea, Thyroidinum LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC AESCULUS HIPPOCASTANUM FLOWER; ALFALFA; AMBROSIA ARTEMISIIFOLIA; ANHYDROUS CITRIC ACID; AVENA SATIVA FLOWERING TOP; BOS TAURUS HYPOTHALAMUS; CARBON MONOXIDE; CARPINUS BETULUS FLOWERING TOP; EGG PHOSPHOLIPIDS; EPINEPHRINE; GELSEMIUM SEMPERVIRENS ROOT; OLEA EUROPAEA FLOWER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 55926-0012_24bcef55-2eac-4481-8f9c-9c92fd044caa 55926-0012 HUMAN OTC DRUG Serenity Remedy No. 12 Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Clematis erecta, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Impatiens glandulifera, flos, ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, sulphur, symphytum officinale, Veratrum album LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS RECTA FLOWERING TOP; CLEMATIS VITALBA FLOWER; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; STRYCHNOS IGNATII SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 55926-0014_a7b74dcf-e09a-4384-98a0-48488432e353 55926-0014 HUMAN OTC DRUG Steady Remedy No. 14 Aconitum napellus, Alfalfa, Argentum nitricum, Arsenicum album, Aurum metallicum, Avena sativa, Baryta carbonica, Calcarea phosphorica, Chamomilla, Gelsemium sempervirens, Glonoinum, Humulus lupulus, Ignatia amara, Kali arsenicosum, Kali phosphoricum, Muriaticum acidum, Natrum phosphoricum, Passiflora incarnata, Phosphorus, Staphysagria, Stramonium LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC ACONITUM NAPELLUS; ALFALFA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; GOLD; HOPS; HYDROCHLORIC ACID; MATRICARIA RECUTITA; NITROGLYCERIN; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; POTASSIUM ARSENITE ANHYDROUS; POTASSIUM PHOSPHATE, DIBASIC; SILVER NITRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS IGNATII SEED; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 55926-0015_57fbec61-a8ac-4595-b2f4-805c8c9eaac2 55926-0015 HUMAN OTC DRUG Slim Remedy No. 15 Adrenalinum, Adrenocorticotrophin, Agrimonia eupatoria, flos, Anacardium orientale, Antimonium crudum, Calcarea carbonica, Castanea sativa, flos, Cortisone aceticum, Fucus vesiculosus, Hypothalamus, Kali bichromicum, Oleander, Pituitarum posterium, Sabadilla, Staphysagria, Thyroidinum LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC AGRIMONIA EUPATORIA FLOWER; ANTIMONY TRISULFIDE; BOS TAURUS HYPOTHALAMUS; CASTANEA SATIVA FLOWER; CORTICOTROPIN; CORTISONE ACETATE; DELPHINIUM STAPHISAGRIA SEED; EPINEPHRINE; FUCUS VESICULOSUS; NERIUM OLEANDER LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; SCHOENOCAULON OFFICINALE SEED; SEMECARPUS ANACARDIUM JUICE; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 55926-0016_c836c281-33da-4a08-b43e-b569753cb7c0 55926-0016 HUMAN OTC DRUG Regular Remedies No. 16 Alumina, Bellis perennis, Causticum, Collinsonia canadensis, Hydrastis canadensis, Lac defloratum, Natrum muriaticum, Nux vomica, Plumbum metallicum, Sepia LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; LEAD; SEPIA OFFICINALIS JUICE; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 55926-0017_6732e61f-34f6-4d5b-8d37-b77a51aacb2a 55926-0017 HUMAN OTC DRUG Control Remedy No. 17 Aloe socotrina, Chamomilla, Cinchona officinalis, Colocynthis, Crotontiglium, Cuprum arsenicosum, Gelsemium sempervirens, Ipecacuanha, Nux vomica, Phosphoricum acidum, Podophyllum peltatum Veratrum album LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC ALOE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; MATRICARIA RECUTITA; PHOSPHORIC ACID; PODOPHYLLUM; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 55926-0018_1620b3f8-60d1-4969-bef3-d8c01f2c5e26 55926-0018 HUMAN OTC DRUG Recharge Remedy No. 18 Alfalfa, Ambra grisea, Anacardium orientale, Argentum nitricum, Aurum metallicum, Avena sativa, Caladium seguinum, Calcarea carbonica, Cocculus indicus, Gelsemium sempervirens, Ignatia amara, Kali phosphoricum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Phosphoricum acidum, Phosphorus, Selenium metallicum, Sepia, Silicea, Sulphur LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC ALFALFA; AMBERGRIS; ANAMIRTA COCCULUS SEED; AVENA SATIVA FLOWERING TOP; DIEFFENBACHIA SEGUINE; GELSEMIUM SEMPERVIRENS ROOT; GOLD; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 55926-0019_38b30db7-7ac2-49cf-b3c1-f99438c9ecf7 55926-0019 HUMAN OTC DRUG Morale Remedy No. 19 Anacardium orientale, Aurum metallicum, Calcarea carbonica, Cimicifuga racemosa, Hypericum perforatum, Ignatia amara, Kale bromatum, Natrum carbonicum, Natrum sulphuricum, Phosphoricum acidum, Phosphorus, Pulsatilla, Sepia, Tabacum LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC BLACK COHOSH; GOLD; HYPERICUM PERFORATUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM BROMIDE; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS IGNATII SEED; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 55926-0020_ab41e59d-245a-411a-9435-bd642bc852e6 55926-0020 HUMAN OTC DRUG Soothe Remedy No. 20 Belladonna, Bryonia, Capsicum annuum, Chininum arsenicosum, Coffea cruda, Gelsemium sempervirens, Glonoinum, Ignatia amara, Kali bichromicum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Sanguinaria canadensis, Spigelia anthelmia, Sulphur LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC ARABICA COFFEE BEAN; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAPSICUM; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; POTASSIUM DICHROMATE; QUININE ARSENITE; SANGUINARIA CANADENSIS ROOT; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 55926-0021_cc3aa127-2458-432e-b39a-da36fb0ae417 55926-0021 HUMAN OTC DRUG Relieve Remedy No. 21 Apis mellifica, Chamomilla, Cimicifuga racemosa, Cyclamen europaeum, Helonias dioica, Ignatia amara, Lac caninum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Platinum metallicum, Sepia LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC APIS MELLIFERA; BLACK COHOSH; CANIS LUPUS FAMILIARIS MILK; CHAMAELIRIUM LUTEUM ROOT; CYCLAMEN PURPURASCENS TUBER; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PLATINUM; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 55926-0022_70e210fc-95c4-4f52-8445-4f4ac7ee2bcf 55926-0022 HUMAN OTC DRUG Invigorate Male Remedy No. 22 Agnus castus, Arnica montana, Baryta carbonica, Caladium seguinum, Kali bromatum, Lycopodium clavatum, Nuphar luteum, Nux vomica, Onosmodium virginianum, Phosphoricum acidum, Picricum acidum, Selenium metallicum LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC ARNICA MONTANA; BARIUM CARBONATE; CHASTE TREE; DIEFFENBACHIA SEGUINE; LYCOPODIUM CLAVATUM SPORE; NUPHAR LUTEUM ROOT; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; PICRIC ACID; POTASSIUM BROMIDE; SELENIUM; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 55926-0023_067b4185-43ea-468b-8228-1a601ebd4e0c 55926-0023 HUMAN OTC DRUG Invigorate Female Remedy No. 23 Agnus castus, Aletris farinosa, Berberis vulgaris, Caulopyllum thalictroides, Ferrum metallicum, Graphites, Helonias dioica, Ignatia amara, Lilium tigrinum, Lycopodium clavatum, Natrum muriaticum, Onosmodium virginianum, Pulsatilla, Sepia LIQUID ORAL 20130722 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC ALETRIS FARINOSA ROOT; BERBERIS VULGARIS ROOT BARK; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; GRAPHITE; IRON; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; ONOSMODIUM VIRGINIANUM WHOLE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 55926-0024_c032250a-2e98-4bd0-95a1-a248d9f4f143 55926-0024 HUMAN OTC DRUG EmuAid Silver LIQUID TOPICAL 20140116 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC SILVER 10 [hp_X]/59mL 55926-0025_e8f2eb94-4f87-4066-893a-74ad379deb62 55926-0025 HUMAN OTC DRUG emuaidMAX Silver LIQUID TOPICAL 20140122 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC SILVER 10 [hp_X]/100mL 55946-701_a97efbc6-c4c6-4bd9-a1eb-e20bca6cb9d4 55946-701 HUMAN OTC DRUG CALENDULA DIAPER RASH CREAM ZINC OXIDE CREAM TOPICAL 20130716 OTC MONOGRAPH FINAL part347 Weleda, Inc. ZINC OXIDE 12 g/100g 55946-702_4dda595d-1798-4a38-af94-b1b1e588a1af 55946-702 HUMAN OTC DRUG WHITE MALLOW DIAPER RASH CREAM ZINC OXIDE CREAM TOPICAL 20140826 OTC MONOGRAPH FINAL part347 Weleda, Inc. ZINC OXIDE 14 g/100g 55992-023_76022b1f-449d-418a-9065-47b565f9efa0 55992-023 HUMAN OTC DRUG DermaSana Miconazole Nitrate CREAM TOPICAL 20130214 OTC MONOGRAPH FINAL part333C OMG Medical Group, LLC MICONAZOLE NITRATE; TRICLOSAN 200; 30 mg/mg; mg/mg 55992-404_d9a1c2da-0ecb-4fce-b846-e06133ccffa8 55992-404 HUMAN OTC DRUG PainMD Max Capsaicin, Histamine Dihydrocholoride CREAM TOPICAL 20140722 OTC MONOGRAPH NOT FINAL part348 OMG Medical Group, LLC CAPSAICIN; HISTAMINE DIHYDROCHLORIDE 3.75; 3.5 mg/mg; mg/mg 55992-711_10c85210-171d-4786-bac7-29ff0e86a4cc 55992-711 HUMAN OTC DRUG Nail MD Miconazole Nitrate CREAM TOPICAL 20130214 OTC MONOGRAPH FINAL part333C OMG Medical Group, LLC MICONAZOLE NITRATE 200 mg/mg 55992-717_83fb189b-4b17-42e9-b8f6-6ba95ac31796 55992-717 HUMAN OTC DRUG Nail MD Tolnafate, Triclosan SPRAY TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part333A OMG Medical Group, LLC TOLNAFTATE; TRICLOSAN 100; 20 mg/mg; mg/mg 56062-002_517ac107-b9be-4314-bc86-2421fdb4611c 56062-002 HUMAN OTC DRUG enema Saline ENEMA RECTAL 20091130 OTC MONOGRAPH NOT FINAL part334 Publix Super Markets Inc SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 56062-003_14489afe-b02a-4203-b1a7-c4202bd1032e 56062-003 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20080917 OTC MONOGRAPH FINAL part333D Publix Super Markets SALICYLIC ACID 19.8 mg/g 56062-008_0388af93-2676-4fd3-87e3-112f1006f44e 56062-008 HUMAN OTC DRUG Pain relief infants Acetaminophen SUSPENSION/ DROPS ORAL 19930818 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 80 mg/.8mL 56062-010_98afa103-71ae-4c37-9195-9defff018a57 56062-010 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20060905 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 500 mg/1 56062-013_24592af1-cef0-43fa-a42f-b1ce12dff181 56062-013 HUMAN OTC DRUG allergy relief d 12 hour Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20130509 ANDA ANDA076050 Publix Super Markets Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 56062-027_ee2c647f-4a2c-44e8-ac48-c6d008cb48af 56062-027 HUMAN OTC DRUG Aspirin Enteric Safety Coated Aspirin TABLET, COATED ORAL 20130815 OTC MONOGRAPH FINAL part343 Publix Supermarkets, Inc. ASPIRIN 81 mg/1 56062-029_54b891ec-2056-42bb-b47c-e7938025b5a8 56062-029 HUMAN OTC DRUG stop smoking aid Nicotine Polacrilex GUM, CHEWING ORAL 20051206 ANDA ANDA076775 Publix Super Markets Inc NICOTINE 2 mg/1 56062-041_bdf089ee-f3b0-4881-8218-7cfc9fa7140b 56062-041 HUMAN OTC DRUG Publix Cherry Flavor Nitetime acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090709 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 56062-046_939c24d5-ce9e-47e2-aebd-3ef3961321ab 56062-046 HUMAN OTC DRUG pain relief Acetaminophen TABLET, COATED ORAL 20110829 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 500 mg/1 56062-047_0680b388-71e2-4410-8558-964d828ed8eb 56062-047 HUMAN OTC DRUG maximum strength Ranitidine TABLET ORAL 20090127 ANDA ANDA078653 Publix Super Markets Inc RANITIDINE HYDROCHLORIDE 150 mg/1 56062-050_0240bec9-9477-4d58-9a19-63bb5d2795e0 56062-050 HUMAN OTC DRUG ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20110915 ANDA ANDA079113 Publix Super Markets Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 56062-054_06092347-33fe-46b8-829c-70e4ca15ecf2 56062-054 HUMAN OTC DRUG nasal decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000320 ANDA ANDA075153 Publix Super Markets Inc PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 56062-056_f681d986-9838-42d8-8ed9-732a39fbf870 56062-056 HUMAN OTC DRUG nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140217 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 56062-057_84aea3fc-4f3b-4a76-a3a6-94ed6549dbea 56062-057 HUMAN OTC DRUG profen ib infants ibuprofen SUSPENSION ORAL 20010629 ANDA ANDA075217 Publix Super Markets Inc IBUPROFEN 50 mg/1.25mL 56062-065_1234273f-f59b-4a10-bb22-d062f2565d89 56062-065 HUMAN OTC DRUG extra moisturizing Oxymetazoline HCl SPRAY NASAL 19980507 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 56062-069_7e325c4f-f4e2-47fc-a389-e3cdd7c33f80 56062-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 20090113 OTC MONOGRAPH FINAL part347 Publix Super Markets, Inc PETROLATUM 1 g/g 56062-072_9ac4be4e-687f-4fb9-93cb-c6f79b969121 56062-072 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19980106 OTC MONOGRAPH NOT FINAL part356 Publix Super Markets EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 56062-074_66ddf999-aa22-4503-a683-33c511607d75 56062-074 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 20060322 ANDA ANDA077349 Publix Super Markets Inc IBUPROFEN 200 mg/1 56062-080_e8b86950-406e-4f21-871c-f441b4c85c79 56062-080 HUMAN OTC DRUG Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Publix Super Markets Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g 56062-083_32757a3c-220b-43a1-b686-9ec04e01371c 56062-083 HUMAN OTC DRUG ibuprofen cold and sinus Ibuprofen, Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011207 ANDA ANDA074567 Publix Super Markets Inc IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 56062-090_0a6891a2-119f-40ab-a395-093fdf05a385 56062-090 HUMAN OTC DRUG daytime pe nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110516 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc 56062-090_9c6714ba-daa2-4600-96cc-942759bedff5 56062-090 HUMAN OTC DRUG daytime pe nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20121029 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc 56062-090_cd2380a6-e7b3-4ad1-9f2b-f97718553e0e 56062-090 HUMAN OTC DRUG daytime pe nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20081015 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc 56062-094_ffb0be31-6a30-4cfc-ade4-b328cd12bb9b 56062-094 HUMAN OTC DRUG nasal decongestant pe non drowsy Phenylephrine Hydrochloride TABLET ORAL 20050610 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 56062-117_c388491d-cf74-4cd6-ae9f-84171e2c7914 56062-117 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120810 ANDA ANDA202319 Publix Super Markets Inc LANSOPRAZOLE 15 mg/1 56062-121_ffd7feec-8b98-4aac-8803-50e7c7df39aa 56062-121 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120703 ANDA ANDA202300 Publix Supermarkets, Inc. IBUPROFEN 200 mg/1 56062-122_253f58f4-d3e1-404b-b094-dae0456f2996 56062-122 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120703 ANDA ANDA202300 Publix Supermarkets, Inc. IBUPROFEN 200 mg/1 56062-141_02436e57-65fb-45a4-b712-c4a6e9317e73 56062-141 HUMAN OTC DRUG acid reducer Famotidine TABLET ORAL 20091123 ANDA ANDA075400 Publix Super Markets Inc FAMOTIDINE 10 mg/1 56062-153_be719598-d98c-49fe-a528-6b8d9de2b21b 56062-153 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090113 OTC MONOGRAPH FINAL part358H Publix Super Markets, Inc PYRITHIONE ZINC 1 g/100mL 56062-160_a8b1f7e9-78cf-4631-9375-938d5abb0fda 56062-160 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20121220 OTC MONOGRAPH FINAL part346 Publix Super Markets Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g 56062-161_157eb14d-5ef8-4f24-82f0-b11b05e25d72 56062-161 HUMAN OTC DRUG Pain Relief Acetaminophen LIQUID ORAL 20111129 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 160 mg/5mL 56062-163_08223c1c-2d05-49c8-bff3-a3b99da90436 56062-163 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20110720 OTC MONOGRAPH FINAL part355 Publix Super Markets, Inc SODIUM FLUORIDE 1 mg/mL 56062-165_46996818-35f9-401d-accd-19febf5c171d 56062-165 HUMAN OTC DRUG allergy relief d 24 hour Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20030625 ANDA ANDA075706 Publix Super Markets Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 56062-166_205da0e2-0bae-4680-a9e4-cb14afcc2d29 56062-166 HUMAN OTC DRUG profen ib Ibuprofen SUSPENSION ORAL 20031118 ANDA ANDA074937 Publix Super Markets Inc IBUPROFEN 100 mg/5mL 56062-170_7a2465e8-ba4b-4b0d-92a2-8d5c425391a0 56062-170 HUMAN OTC DRUG stop smoking aid Nicotine Polacrilex GUM, CHEWING ORAL 20051206 ANDA ANDA076789 Publix Super Markets Inc NICOTINE 4 mg/1 56062-175_fe08002b-ffe4-446f-b6e2-d852f3cafeef 56062-175 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 20030828 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 160 mg/5mL 56062-176_9ffd8442-e136-403f-8396-8b844c2d6887 56062-176 HUMAN OTC DRUG Allergy Relief D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20100311 ANDA ANDA077170 Publix Super Markets Inc CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 56062-179_e7a973e8-3a54-4fc2-87a6-93e514e2b076 56062-179 HUMAN OTC DRUG extra strength antacid calcium supplement Calcium carbonate TABLET, CHEWABLE ORAL 20020521 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc CALCIUM CARBONATE 750 mg/1 56062-184_8e4ec9ab-fbca-43ca-ae3b-9f0a70ddc693 56062-184 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20120619 OTC MONOGRAPH NOT FINAL part343 Publix Supermarkets, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 56062-187_7aa539a8-f445-4020-a12d-7d374fda3b65 56062-187 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET, COATED ORAL 19950206 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 500 mg/1 56062-188_7b360d3b-fb2b-4f35-a04d-203dd352933d 56062-188 HUMAN OTC DRUG Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20131202 OTC MONOGRAPH FINAL part346 Publix Super Markets Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 56062-194_f692ed61-d09a-484e-bf07-8afcedfb3208 56062-194 HUMAN OTC DRUG maximum strength Famotidine TABLET ORAL 20071203 ANDA ANDA077351 Publix Super Markets Inc FAMOTIDINE 20 mg/1 56062-199_49cc37f4-c2a4-4ee6-b73f-a67db08a06fa 56062-199 HUMAN OTC DRUG Ibuprofen IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20130430 ANDA ANDA078682 Publix Supermarkets, Inc. IBUPROFEN 200 mg/1 56062-202_477cdc2c-4e4f-47ed-80b8-b7d9729bb587 56062-202 HUMAN OTC DRUG minoxidil for women minoxidil SOLUTION TOPICAL 20110404 ANDA ANDA075357 Publix Super Markets Inc MINOXIDIL 2 g/100mL 56062-204_8bb0e036-6f17-4440-8257-7e80df738aac 56062-204 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Publix Super Markets Inc PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 56062-205_7fe041ea-88bd-4ceb-a081-6fc9c5d3a4b2 56062-205 HUMAN OTC DRUG Therapeutic T Plus Coal Tar SHAMPOO TOPICAL 20071012 OTC MONOGRAPH FINAL part358H Publix Super Markets, Inc. COAL TAR 25 mg/mL 56062-206_b98ecba7-0415-45b7-a25c-743a3d24751e 56062-206 HUMAN OTC DRUG stop smoking aid nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20051206 ANDA ANDA078325 Publix Super Markets Inc NICOTINE 2 mg/1 56062-213_7161c1e2-61fe-4b9c-828c-801f5c13799a 56062-213 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20070819 OTC MONOGRAPH FINAL part355 Publix Super Markets, Inc SODIUM FLUORIDE .05 kg/100L 56062-215_9826c6ef-3716-4e54-84ff-6ba786cae31e 56062-215 HUMAN OTC DRUG daytime pe non drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 19960222 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 56062-224_44773392-eac8-48b3-ae46-b27f5fe55d8d 56062-224 HUMAN OTC DRUG anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030319 ANDA ANDA075232 Publix Super Markets Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 56062-227_5b5ab2c1-ec74-4837-b2e3-786b7804a9f1 56062-227 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET, COATED ORAL 20071126 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 500 mg/1 56062-234_2d381f80-17a8-4705-803b-1c7f4d5fb9bd 56062-234 HUMAN OTC DRUG severe cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20071025 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 56062-247_371203f0-dd35-4300-bff1-aaf9672ae168 56062-247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140530 OTC MONOGRAPH NOT FINAL part343 Publix Supermarkets, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 56062-250_e74ed230-6cc5-4a83-b1ca-a7c935015c04 56062-250 HUMAN OTC DRUG cold relief Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20090303 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc 56062-255_027b925e-541f-44ac-af74-90163d7b8b47 56062-255 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20110909 ANDA ANDA075217 Publix Super Markets Inc IBUPROFEN 50 mg/1.25mL 56062-259_c1bfdd5f-9630-435c-986c-6fb0685a6da2 56062-259 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 19990702 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ASPIRIN 81 mg/1 56062-271_79bdbec6-d157-4ce2-bb38-9337fef9df30 56062-271 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20090608 ANDA ANDA076760 Publix Super Markets Inc RANITIDINE HYDROCHLORIDE 75 mg/1 56062-272_2188560d-c995-43e1-9963-124d5a0cbb56 56062-272 HUMAN OTC DRUG sinus relief non drowsy Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20071126 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 56062-274_88b0d897-b93f-42c3-88d0-784dd6c555e4 56062-274 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 19980824 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ASPIRIN 81 mg/1 56062-279_a241cb37-7007-4fd8-a12e-f3fc6d6f780e 56062-279 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140908 OTC MONOGRAPH FINAL part346 Publix Super Markets Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 56062-281_6250ce02-f99b-4516-ab81-2b88a685d774 56062-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090113 OTC MONOGRAPH FINAL part358H Publix PYRITHIONE ZINC 10.4 mg/mL 56062-282_1257b2e0-4ae6-4aab-b1f3-c93fd70116c6 56062-282 HUMAN OTC DRUG dayhist allergy Clemastine fumarate TABLET ORAL 19961120 ANDA ANDA074512 Publix Super Markets Inc CLEMASTINE FUMARATE 1.34 mg/1 56062-288_8b2d8ce4-da28-48ed-9454-d5f13b50f846 56062-288 HUMAN OTC DRUG childrens mucus relief Guaifenesin LIQUID ORAL 20121214 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc GUAIFENESIN 100 mg/5mL 56062-294_7fbe2cb2-0427-44d4-8ec4-55c5ab742bad 56062-294 HUMAN OTC DRUG minoxidil foam Minoxidil AEROSOL, FOAM TOPICAL 20130617 ANDA ANDA091344 Publix Super Markets Inc MINOXIDIL 5 g/100g 56062-299_12c6064a-cfa1-407b-a7e7-f20dee96cd1b 56062-299 HUMAN OTC DRUG Zestymint Antiseptic cetylpyridinium chloride MOUTHWASH ORAL 20080506 OTC MONOGRAPH NOT FINAL part356 Publix Super Markets, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL 56062-302_c187e324-9b42-4049-9737-fe15d2ba70d1 56062-302 HUMAN OTC DRUG original formula stomach relief Bismuth subsalicylate LIQUID ORAL 19950329 OTC MONOGRAPH FINAL part335 Publix Super Markets Inc BISMUTH SUBSALICYLATE 262 mg/15mL 56062-304_377b8cc5-3567-4593-b62f-9ac70565e3d5 56062-304 HUMAN OTC DRUG original oxymetazoline hydrochloride SPRAY NASAL 19911113 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 56062-306_0e6beb4e-1e85-4593-93cb-7540eeef639c 56062-306 HUMAN OTC DRUG clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091214 ANDA ANDA090685 Publix Super Markets Inc POLYETHYLENE GLYCOL 3350 17 g/17g 56062-308_1a77d8ef-8277-44b8-9203-e175c2af827e 56062-308 HUMAN OTC DRUG severe cold multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20090226 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 56062-310_fe467f94-0b83-4b7a-8519-c95b2a4dc51e 56062-310 HUMAN OTC DRUG tussin expectorant for adults Guaifenesin SYRUP ORAL 20040213 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc GUAIFENESIN 200 mg/10mL 56062-311_8326fd4c-ee6b-42b7-b831-18211668decf 56062-311 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20101005 OTC MONOGRAPH FINAL part358H Publix PYRITHIONE ZINC 1 kg/100L 56062-318_b8b63bf4-e2fe-4b3b-bf29-75ae8edabc16 56062-318 HUMAN OTC DRUG Original Antiseptic Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 19910611 OTC MONOGRAPH NOT FINAL part356 Publix EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 56062-321_03fc1a18-a660-458b-b2fa-fd2072bcc29f 56062-321 HUMAN OTC DRUG dual action famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20081205 ANDA ANDA077355 Publix Super Markets Inc CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 56062-332_4589c0b1-d75c-4528-8343-6e8d9be1b591 56062-332 HUMAN OTC DRUG mint milk of magnesia Magnesium hydroxide LIQUID ORAL 19940902 OTC MONOGRAPH NOT FINAL part334 Publix Super Markets Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 56062-335_6b839f2f-28d5-4eae-9541-24ff46a52f1b 56062-335 HUMAN OTC DRUG Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20111121 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 56062-337_d6ac330e-a336-4071-b31c-f27a99eb45cf 56062-337 HUMAN OTC DRUG maximum strength Bismuth subsalicylate LIQUID ORAL 20020808 OTC MONOGRAPH FINAL part335 Publix Super Markets Inc BISMUTH SUBSALICYLATE 525 mg/15mL 56062-344_896f457b-f89b-4323-858f-655700f79fd2 56062-344 HUMAN OTC DRUG stop smoking aid Nicotine Polacrilex LOZENGE ORAL 20060412 ANDA ANDA077007 Publix Super Markets Inc NICOTINE 2 mg/1 56062-357_a34d3f12-06f5-4e5d-9496-8615b9213367 56062-357 HUMAN OTC DRUG Regular Strength antacid anti gas Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19940912 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 56062-359_d4c6c9ad-bd3d-47a3-8f22-4264abcca8b9 56062-359 HUMAN OTC DRUG Tussin DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140210 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 56062-368_e64c66ff-95fe-4983-895a-a6feae0c01b7 56062-368 HUMAN OTC DRUG All Day Relief Naproxen Sodium TABLET, FILM COATED ORAL 19971229 ANDA ANDA074661 Publix Super Markets Inc NAPROXEN SODIUM 220 mg/1 56062-374_5ea251ae-2d04-4e20-947c-24c41c63c2a1 56062-374 HUMAN OTC DRUG migraine relief Acetaminophen, Aspirin, Caffeine TABLET ORAL 20021226 ANDA ANDA075794 Publix Super Markets Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 56062-376_c87fd358-56f6-4788-97a6-4bcc16b77738 56062-376 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140930 OTC MONOGRAPH NOT FINAL part356 Publix Supermarkets, Inc. PHENOL 1.4 g/100mL 56062-377_6256c010-e519-498a-a08e-b07071d1c77f 56062-377 HUMAN OTC DRUG Sore Throat Menthol Phenol SPRAY ORAL 20140930 OTC MONOGRAPH NOT FINAL part356 Publix Supermarkets, Inc. PHENOL 1.4 g/100mL 56062-379_cc6e4e26-84f5-4003-b1eb-f0e06d3e294e 56062-379 HUMAN OTC DRUG Childrens Allergy Diphenhydramine HCl LIQUID ORAL 20140211 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 56062-384_5a71cad4-8816-47f4-840c-27765d377f0a 56062-384 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20140225 ANDA ANDA091135 Publix Super Markets Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 56062-388_78a1f832-1040-4b25-8c67-d582ad6abf84 56062-388 HUMAN OTC DRUG no drip Oxymetazoline HCl SPRAY NASAL 20021226 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 56062-393_dfd01fce-8ea6-4f7b-8b0f-4434e8de16c8 56062-393 HUMAN OTC DRUG nighttime cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20071203 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 56062-396_1447e9ce-dc51-4474-9317-6f77c5a7a20f 56062-396 HUMAN OTC DRUG Original Magnesium hydroxide LIQUID ORAL 19940902 OTC MONOGRAPH NOT FINAL part334 Publix Super Markets Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 56062-402_30531136-37ad-446f-a77e-d965fc03dee8 56062-402 HUMAN OTC DRUG Cold Daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20071126 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 56062-409_885c6897-20c1-4ce1-9b4b-ff692f6f0e4b 56062-409 HUMAN OTC DRUG stay awake Caffeine TABLET ORAL 19980106 OTC MONOGRAPH FINAL part340 Publix Super Markets Inc CAFFEINE 200 mg/1 56062-416_5a1f6e47-f72f-43df-8d7a-ddef24dd9080 56062-416 HUMAN OTC DRUG aspirin Aspirin TABLET ORAL 19880915 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ASPIRIN 325 mg/1 56062-422_d9396d79-86aa-4ca5-8f6c-bb6401ff4bca 56062-422 HUMAN OTC DRUG Stop Smoking Aid Nicotine Polacrilex GUM, CHEWING ORAL 20051206 ANDA ANDA078326 Publix Super Markets Inc NICOTINE 4 mg/1 56062-423_ea1212c0-ea76-499b-8df6-0bf6ff60cdc7 56062-423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Publix Super Markets Inc IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 56062-430_a2c7a66e-dd5b-41dc-95bf-b3077c1c6cdd 56062-430 HUMAN OTC DRUG headache relief added strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19980824 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 56062-431_3e587ea9-2f0b-4d39-ad23-67436804fe48 56062-431 HUMAN OTC DRUG sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20010724 OTC MONOGRAPH FINAL part338 Publix Super Markets Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 56062-432_7f0c3b3a-afdd-4d8f-950f-1faf03d30594 56062-432 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 19930909 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 56062-434_7e61623c-91a9-414e-85a6-942f3c9406a5 56062-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130822 OTC MONOGRAPH NOT FINAL part356 Publix Super Markets EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 56062-437_586a9b79-7118-47ca-abc4-743e87c9082a 56062-437 HUMAN OTC DRUG pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19930922 OTC MONOGRAPH FINAL part338 Publix Super Markets Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 56062-440_45abf518-36cb-4c85-bca1-c318ca8e5987 56062-440 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin TABLET, COATED ORAL 20130104 OTC MONOGRAPH FINAL part343 Publix Supermarkets, Inc. ASPIRIN 81 mg/1 56062-445_6777705d-adae-4a9f-9016-716ab61d3035 56062-445 HUMAN OTC DRUG flu and severe cold and cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20140313 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 56062-458_e4cd7f10-4d6e-415c-ba36-7f48397c8785 56062-458 HUMAN OTC DRUG allergy relief Cetirizine Hydrochloride TABLET ORAL 20090121 ANDA ANDA078336 Publix Super Markets Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 56062-459_7f49bd17-5af8-45e1-9e6e-7dce515395ae 56062-459 HUMAN OTC DRUG nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20111107 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 56062-461_710aba07-3a81-47ab-89fb-3b4427468960 56062-461 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20041028 ANDA ANDA076359 Publix Super Markets Inc IBUPROFEN 100 mg/1 56062-462_965af5c2-babd-4b3b-a6bc-ebeff21b993c 56062-462 HUMAN OTC DRUG allergy diphenhydramine hydrochloride CAPSULE ORAL 19930831 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 56062-467_a49686c1-9edc-4fc9-ac09-83c242b93fa1 56062-467 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 19990702 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ASPIRIN 81 mg/1 56062-468_9a42503a-6a0a-411b-9007-d386811b1d55 56062-468 HUMAN OTC DRUG extra strength Calcium carbonate TABLET, CHEWABLE ORAL 20020509 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc CALCIUM CARBONATE 750 mg/1 56062-469_d70593ec-a826-41d7-a823-f9fefc7c47a2 56062-469 HUMAN OTC DRUG chewable Bismuth subsalicylate TABLET, CHEWABLE ORAL 20010315 OTC MONOGRAPH FINAL part335 Publix Super Markets Inc BISMUTH SUBSALICYLATE 262 mg/1 56062-476_2cfa2450-21ee-451c-b5a0-7303682f97cb 56062-476 HUMAN OTC DRUG allergy sinus pe pain relief Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20060712 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 56062-478_231f6521-c401-47b8-9edf-c0d3c5cf2981 56062-478 HUMAN OTC DRUG regular strength calcium carbonate TABLET, CHEWABLE ORAL 19941011 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc CALCIUM CARBONATE 500 mg/1 56062-479_23a98385-28cc-4fac-8c87-b3ced8106532 56062-479 HUMAN OTC DRUG allergy Diphenhydramine Hydrochloride TABLET ORAL 19980507 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 56062-484_885bc959-3164-479a-882c-49445aa1eb7f 56062-484 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET ORAL 19880915 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 500 mg/1 56062-485_9cf1d5dd-aa7d-46fc-8bd2-583b5a2c3ab3 56062-485 HUMAN OTC DRUG Regular Strength Antacid Calcium Supplement calcium carbonate TABLET, CHEWABLE ORAL 19940902 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc CALCIUM CARBONATE 500 mg/1 56062-489_252400f2-7f0f-4702-b2b6-8edef0c1379b 56062-489 HUMAN OTC DRUG extra strength Calcium carbonate TABLET, CHEWABLE ORAL 20020521 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc CALCIUM CARBONATE 750 mg/1 56062-490_e716f4b0-c94a-44a4-a819-7985bf7d9e5b 56062-490 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET ORAL 19971229 ANDA ANDA074661 Publix Super Markets Inc NAPROXEN SODIUM 220 mg/1 56062-496_26bdd132-144d-4aba-9ece-d48222ffcec5 56062-496 HUMAN OTC DRUG cold relief Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20090226 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc 56062-498_a8a6a59a-574d-4444-97f6-ffef1812e37f 56062-498 HUMAN OTC DRUG Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130325 ANDA ANDA078912 Publix Super Markets Inc GUAIFENESIN 600 mg/1 56062-500_12487cb3-baf5-4464-a16a-993d0c3dccd6 56062-500 HUMAN OTC DRUG severe cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20140519 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 56062-516_ec79c4e0-3111-4a2a-b0dc-5e05d75625be 56062-516 HUMAN OTC DRUG Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 19930319 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 56062-517_26aded93-0976-4892-8eae-edb875e7e430 56062-517 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060503 ANDA ANDA077349 Publix Super Markets Inc IBUPROFEN 200 mg/1 56062-526_fba0b636-da83-40bc-8b42-cac904d65edd 56062-526 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Publix Super Markets Inc LORATADINE 10 mg/1 56062-535_3b146a9c-d098-4b2e-b547-c78742f021cb 56062-535 HUMAN OTC DRUG Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20010315 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ASPIRIN 81 mg/1 56062-544_7108a81f-ccfe-450d-bdab-33e75329cc8e 56062-544 HUMAN OTC DRUG arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20071126 ANDA ANDA075077 Publix Super Markets Inc ACETAMINOPHEN 650 mg/1 56062-571_1d5d5197-cb33-4f42-a406-a4850d0d00b8 56062-571 HUMAN OTC DRUG allergy relief fexofenadine hcl TABLET, FILM COATED ORAL 20120130 ANDA ANDA076447 Publix Super Markets Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 56062-580_af1bbd44-4c2b-424b-abbf-684c515cbec1 56062-580 HUMAN OTC DRUG Daytime PE Nitetime Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140707 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc 56062-588_d982b158-03d7-4623-b58a-6c8aba3fb61f 56062-588 HUMAN OTC DRUG Maximum Strength Antacid Anti Gas Aluminum Hydroxide, Magnesium Hydroxide, Simethicone LIQUID ORAL 20071126 OTC MONOGRAPH FINAL part332 Publix Super Markets Inc ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 56062-590_6b691dc1-09e4-46d3-b199-8917e42848a6 56062-590 HUMAN OTC DRUG pain relief acetaminophen LIQUID ORAL 20111230 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 160 mg/5mL 56062-595_73bcc027-913a-4395-9f26-89203410d44b 56062-595 HUMAN OTC DRUG maximum strength Calcium Carbonate TABLET, CHEWABLE ORAL 20020429 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc CALCIUM CARBONATE 1000 mg/1 56062-600_db3c5172-887e-42b3-906a-9b84c1c00077 56062-600 HUMAN OTC DRUG ultrastrength Calcium Carbonate TABLET, CHEWABLE ORAL 20140730 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc CALCIUM CARBONATE 1000 mg/1 56062-602_b3be1f47-ae76-41d3-881e-579668518d6a 56062-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20140905 OTC MONOGRAPH NOT FINAL part334 Publix Super Markets, Inc MAGNESIUM SULFATE 1 g/g 56062-604_385a1b5e-5d19-4e53-b683-0c7a4c8e501d 56062-604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880915 ANDA ANDA072096 Publix Super Markets Inc IBUPROFEN 200 mg/1 56062-616_9f89affe-b347-46ba-8209-7cbbd0dd9d10 56062-616 HUMAN OTC DRUG allergy sinus PE Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20141029 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 56062-619_e128b848-6b7e-486d-927c-2bcd64fb7dec 56062-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 19930319 OTC MONOGRAPH FINAL part347 Publix Super Markets Inc DIMETHICONE 1.3 kg/100mL 56062-647_e41e0d2a-a6bd-4417-895f-7a22f49a844c 56062-647 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 19880915 ANDA ANDA072096 Publix Super Markets Inc IBUPROFEN 200 mg/1 56062-648_ac39e549-c8cc-43bf-8a4a-314e571918d1 56062-648 HUMAN OTC DRUG Nasal Four Phenylephrine hydrochloride SPRAY NASAL 20030103 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL 56062-656_4612382b-344f-46ce-91b4-59791ebdcda2 56062-656 HUMAN OTC DRUG day time non drowsy acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20060608 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 56062-664_b74bcecd-0746-4817-aaa3-9d2354d92804 56062-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19940330 OTC MONOGRAPH NOT FINAL part356 Publix Super Markets, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 56062-668_f6d23a99-7377-4521-ba75-dd819a7d8899 56062-668 HUMAN OTC DRUG NIGHTTIME cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20030120 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 56062-678_72b1f7f5-90e4-4e89-af95-11659add85a1 56062-678 HUMAN OTC DRUG hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20121119 OTC MONOGRAPH FINAL part346 Publix Super Markets Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 56062-700_9654554a-5355-4595-abe7-24790dd97307 56062-700 HUMAN OTC DRUG Publix Sunscreen SPF 15 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20121114 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc OCTINOXATE; OXYBENZONE 7.5; 4.5 g/100g; g/100g 56062-701_1721cec1-8510-46e5-9bfd-7a2a6fb130e9 56062-701 HUMAN OTC DRUG Publix Burn Relief LIDOCAINE HCL GEL TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part348 Publix Super Markets Inc LIDOCAINE HYDROCHLORIDE .5 g/100g 56062-702_6214883e-cf1e-42fe-8d14-4097079fb531 56062-702 HUMAN OTC DRUG Publix Burn Relief LIDOCAINE HCL GEL TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part348 Publix Super Markets Inc LIDOCAINE; MENTHOL .5; .1 g/100g; g/100g 56062-703_0aa826db-deb0-46d1-95cc-b4e1eae89fe8 56062-703 HUMAN OTC DRUG Publix SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 56062-704_82230e7f-64eb-4f26-ac62-fac5b635db2f 56062-704 HUMAN OTC DRUG Publix Baby SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 56062-705_07b39def-10e4-4b10-a56b-1b3212a00896 56062-705 HUMAN OTC DRUG Publix Kids SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121114 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 56062-706_f460e104-3c21-472e-99a8-466d98844037 56062-706 HUMAN OTC DRUG Publix Kids AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20121114 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g 56062-707_4b93d386-75d7-4e0f-87e3-015826bcd2f9 56062-707 HUMAN OTC DRUG Publix Sport SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121114 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g 56062-708_5d8f00b9-9947-4476-a8f0-dc3c30161b49 56062-708 HUMAN OTC DRUG Publix SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g 56062-709_26298a56-08de-49c4-bd2f-45a29d9aa918 56062-709 HUMAN OTC DRUG Publix SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130716 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100g; g/100g; g/100g; g/100g 56062-711_ee564f46-20b1-42a1-9544-18ad42c243dd 56062-711 HUMAN OTC DRUG Publix Burn Relief ALOE VERA LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part348 Publix Super Markets Inc LIDOCAINE HYDROCHLORIDE .5 g/100g 56062-712_32232d74-7842-4ea4-aabd-d4f95f11c1ed 56062-712 HUMAN OTC DRUG Publix SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130716 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 4; 4; 5 g/100g; g/100g; g/100g; g/100g; 1/100g 56062-713_afdac898-5b73-408b-8c82-71c8f63b5238 56062-713 HUMAN OTC DRUG Publix SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130716 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g 56062-724_d855ae80-da98-4a5c-8e82-237879a615d1 56062-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Publix Super Markets Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 56062-751_5e55ca00-5b1c-4075-bc58-58cd3ff053e6 56062-751 HUMAN OTC DRUG pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120130 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 56062-798_0b822988-2d8c-4e16-aafd-6058008c0910 56062-798 HUMAN OTC DRUG Minoxidil Minoxidil SOLUTION TOPICAL 20101025 ANDA ANDA075598 Publix Super Markets Inc MINOXIDIL 3 g/60mL 56062-804_186337ba-71f2-47bd-808b-75eed23a7dc4 56062-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20130322 OTC MONOGRAPH NOT FINAL part333A Publix Super Markets, Inc ISOPROPYL ALCOHOL .91 mg/mL 56062-826_5fbc4665-d9cb-4785-b066-4f74a4bdec9a 56062-826 HUMAN OTC DRUG Publix Alcohol Isopropyl Alcohol SWAB TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333A lix Super Markets Inc ISOPROPYL ALCOHOL 70 mL/100mL 56062-837_a7c0db34-1128-4006-81b6-f05facdfdf50 56062-837 HUMAN OTC DRUG pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20080710 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 56062-852_a2c8c2f5-bae2-45e4-9610-66d8f62547ad 56062-852 HUMAN OTC DRUG maximum strength ranitidine Ranitidine TABLET, FILM COATED ORAL 20131125 ANDA ANDA091429 Publix Super Markets Inc RANITIDINE HYDROCHLORIDE 150 mg/1 56062-871_5b37b46d-232a-49c9-b9a8-52c45e81b766 56062-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20021107 OTC MONOGRAPH NOT FINAL part333A Publix Super Markets, Inc HYDROGEN PEROXIDE 30 mg/mL 56062-873_125928b7-95bf-470f-85bc-0326ff449a45 56062-873 HUMAN OTC DRUG stop smoking aid Nicotine Polacrilex LOZENGE ORAL 20060412 ANDA ANDA077007 Publix Super Markets Inc NICOTINE 4 mg/1 56062-897_f16cfecb-1608-4a5b-9cbf-481082c322a3 56062-897 HUMAN OTC DRUG profen IB childrens Ibuprofen SUSPENSION ORAL 20010913 ANDA ANDA074937 Publix Super Markets Inc IBUPROFEN 100 mg/5mL 56062-906_3d8e6fcf-eb51-46d1-89a9-1eee42bfc5bd 56062-906 HUMAN OTC DRUG Childrens Cold and Allergy phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20140211 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 56062-908_9c29cef2-8140-4dac-a3fd-366d4e2702b6 56062-908 HUMAN OTC DRUG NITETIME acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20060601 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 56062-915_18e97449-d110-43d1-8c35-c41c8cd03c4f 56062-915 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080512 NDA NDA022032 Publix Super Markets Inc OMEPRAZOLE 20 mg/1 56062-917_0af5e149-9ac6-47d7-a7ec-298efe325a03 56062-917 HUMAN OTC DRUG pain relief extra strength Acetaminophen CAPSULE, COATED ORAL 20110131 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 500 mg/1 56062-939_a9a8b685-d912-44dd-b2bf-e5f7e9df1325 56062-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Publix Super Markets Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 56062-944_354a640c-bc7e-45c8-9df0-8b5b01767f5c 56062-944 HUMAN OTC DRUG hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20120914 OTC MONOGRAPH FINAL part346 Publix Super Markets Inc GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g 56062-945_2d01f262-6ffe-4056-93f6-7e15388bb173 56062-945 HUMAN OTC DRUG Body Wash triclosan LIQUID TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part333A Publix Super Markets, Inc. BENZALKONIUM CHLORIDE 1.5 mg/mL 56062-949_0627913f-e725-4333-ac87-4868d1001244 56062-949 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide LIQUID ORAL 20050113 OTC MONOGRAPH NOT FINAL part334 Publix Super Markets Inc MAGNESIUM HYDROXIDE 1200 mg/15mL 56062-952_2a411f8c-5c9d-4f02-9cd0-3b2c5c1029f2 56062-952 HUMAN OTC DRUG Epsom Salt MAGNESIUM SULFATE GRANULE ORAL 20130703 OTC MONOGRAPH NOT FINAL part334 Publix Super Markets, Inc., MAGNESIUM SULFATE 1 g/g 56062-964_46dc789d-e1f2-44f8-8ae5-01adc36dd5fc 56062-964 HUMAN OTC DRUG flu and severe cold and cough Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20110929 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 56062-974_6e8b9216-522a-4c7b-b288-ed37f5e7f59e 56062-974 HUMAN OTC DRUG Childrens Allergy cetirizine hydrochloride LIQUID ORAL 20090115 ANDA ANDA090254 Publix Super Markets Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 56062-977_e6b3a23a-4e26-4d2a-bb07-ec77eda71a24 56062-977 HUMAN OTC DRUG nite time Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20060522 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 56062-987_4d5f93c1-7752-4948-ba58-c4385cfc24c8 56062-987 HUMAN OTC DRUG Cold and Cough DM Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20140210 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 56062-994_505d338b-e7ac-4a97-8c4e-8c1e879ebffb 56062-994 HUMAN OTC DRUG daytime pe Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20061102 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 56104-001_d7750a7a-8142-41b9-8540-d378c08fb122 56104-001 HUMAN OTC DRUG Tolnaftate Antifungal Liquid Spray AEROSOL, SPRAY TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. TOLNAFTATE 1.5 g/150g 56104-002_1bdf6604-e504-4436-b29e-254549cddb12 56104-002 HUMAN OTC DRUG Tolnaftate Antifungal Powder Spray AEROSOL, POWDER TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. TOLNAFTATE 1.3 g/130g 56104-005_0bae9a32-6190-4ed9-975a-baa6912572e0 56104-005 HUMAN OTC DRUG Benzocaine and Triclosan First Aid Spray AEROSOL, SPRAY TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Premier Brands of America Inc. BENZOCAINE; TRICLOSAN 17; .11 g/85g; g/85g 56104-006_806046fe-bcb7-4412-824c-3a136b657f6a 56104-006 HUMAN OTC DRUG Lidocaine Burn Relief Spray AEROSOL, SPRAY TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Premier Brands of America Inc. LIDOCAINE .64 g/127g 56104-008_a7ce7e33-4e30-47c8-ae39-c51101b6fc8c 56104-008 HUMAN OTC DRUG Tolnaftate Foot and Sneaker Antifungal Powder Spray AEROSOL, POWDER TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. TOLNAFTATE 1.3 g/113g 56104-009_79301484-c6fd-4d07-b955-a9dbebad16aa 56104-009 HUMAN OTC DRUG Cornex Corn and Callus Liquid Remover LIQUID TOPICAL 20130101 OTC MONOGRAPH FINAL part358F Premier Brands of America Inc. SALICYLIC ACID .17 g/g 56104-010_30e95253-c199-460f-9362-112c07b69b15 56104-010 HUMAN OTC DRUG Salicylic Acid Ultra Thin Corn Removers PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358F Premier Brands of America Inc. SALICYLIC ACID 40 mg/91 56104-011_1416882d-d5f9-4bca-afc1-a2776c3bf7c3 56104-011 HUMAN OTC DRUG Salicylic Acid Corn Removers PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358F Premier Brands of America Inc. SALICYLIC ACID 40 mg/91 56104-012_c7662714-8e3a-47fe-80a5-e5e9490f01f9 56104-012 HUMAN OTC DRUG Salicylic Acid Small Corn Removers PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358F Premier Brands of America Inc. SALICYLIC ACID 40 mg/91 56104-013_b44ad027-66e1-4958-b137-c603ddd60762 56104-013 HUMAN OTC DRUG Salicylic acid Callus Removers PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358F Premier Brands of America Inc. SALICYLIC ACID 40 mg/41 56104-014_f677b8d3-6c96-4bd7-8371-0f80f2ffe3d7 56104-014 HUMAN OTC DRUG Salicylic acid Extra Thick Callus Removers PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358F Premier Brands of America Inc. SALICYLIC ACID 40 mg/41 56104-015_fab33314-82de-4b42-93fa-2cd5df14b94c 56104-015 HUMAN OTC DRUG Diphenhydramine HCl and Zinc Acetate Extra Strength Itch Relief Continuous Spray AEROSOL, SPRAY TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Premier Brands of America Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1.5; .075 g/88mL; g/88mL 56104-017_d3d517e9-69fe-4ee0-889a-d4ca39d05a09 56104-017 HUMAN OTC DRUG Salicylic Acid Wart Removers PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358B Premier Brands of America Inc. SALICYLIC ACID 40 mg/181 56104-018_c3949885-cbd0-4cd3-b9e7-30e9faef9956 56104-018 HUMAN OTC DRUG Plantar Wart Removers Plantar Wart Removers PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358B Premier Brands of America Inc. SALICYLIC ACID 40 mg/100mg 56104-020_3a305f9a-79c7-4a51-9ff0-6fa7d31cd1c4 56104-020 HUMAN OTC DRUG Miconazole Nitrate Miconazorb AF Powder POWDER TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. MICONAZOLE NITRATE 1.42 g/71g 56104-021_2b293615-abaf-4144-bf6f-18b354ce56de 56104-021 HUMAN OTC DRUG Salicylic Acid One-Step Corn Remover Clear PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358F Premier Brands of America Inc. SALICYLIC ACID 40 mg/61 56104-023_2bad2b02-91ce-4902-a878-895c4d9bfae4 56104-023 HUMAN OTC DRUG Wart Remover Liquid Wart Remover Liquid LIQUID TOPICAL 20130101 OTC MONOGRAPH FINAL part358B Premier Brands of America Inc. SALICYLIC ACID .17 g/g 56104-024_fe154c1b-de78-4e02-b186-dc34ef9daacd 56104-024 HUMAN OTC DRUG Salicylic acid One-Step Wart Remover Tan PLASTER TOPICAL 20130601 OTC MONOGRAPH FINAL part358B Premier Brands of America Inc. SALICYLIC ACID .4 g/141 56104-031_05db247e-b62c-41ec-90c6-7af516b9cbcc 56104-031 HUMAN OTC DRUG Calamine Plus Pramoxine HCl Calamine Plus No Touch Spray AEROSOL, SPRAY TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Premier Brands of America Inc. FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE .345; 2.72; 24.16 mg/177mL; mg/177mL; mg/177mL 56104-114_832c55df-39b1-439b-a8d6-0ee1e7697d53 56104-114 HUMAN OTC DRUG Undecylenic Acid Liquid Anti-Fungal Liquid LIQUID TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. UNDECYLENIC ACID .25 g/g 56104-116_2b8e3f9f-1a87-4f7d-a7b8-5bd690b1ff31 56104-116 HUMAN OTC DRUG Undecylenic Acid Anti-Fungal Pen LIQUID TOPICAL 20130701 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. UNDECYLENIC ACID 40 mg/1.7mL 56104-136_203de653-6d06-400e-9b82-61e5d48cb836 56104-136 HUMAN OTC DRUG Menthol Maximum Strength Medicated Foot Powder POWDER TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Premier Brands of America Inc. MENTHOL 2.83 g/283g 56104-141_6a394958-e9a7-4b96-832d-d010c7b367e5 56104-141 HUMAN OTC DRUG Miconazole nitrate Antifungal Miconazole Liquid Continuous Spray AEROSOL, SPRAY TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. MICONAZOLE NITRATE 3 g/150g 56104-237_27c8e3b6-fdbc-4e94-bb70-3bc426476ac6 56104-237 HUMAN OTC DRUG Wart Remover Gel Wart Remover Gel GEL TOPICAL 20130101 OTC MONOGRAPH FINAL part358B Premier Brands of America Inc. SALICYLIC ACID .17 g/g 56104-243_eeef6fe5-ff9b-46e0-a114-3c8eca01f962 56104-243 HUMAN OTC DRUG One-Step Wart Remover Clear One-Step Wart Remover PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358B Premier Brands of America Inc. SALICYLIC ACID .4 g/g 56104-301_fcefbcae-7c42-46b5-9396-476bc30c39c9 56104-301 HUMAN OTC DRUG Miconazole Nitrate Antifungal Miconazole Powder Jock Itch Spray AEROSOL, POWDER TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. MICONAZOLE NITRATE 2.6 g/130g 56104-302_7d351f28-98c5-4ef3-aea3-f7edaac435e7 56104-302 HUMAN OTC DRUG Miconazole nitrate Antifungal Miconazole Powder Spray AEROSOL, POWDER TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. MICONAZOLE NITRATE 2.6 g/130g 56104-527_eeceabef-d260-49ca-a634-6fdea52df39b 56104-527 HUMAN OTC DRUG Tolnaftate Medicated Jock Itch Powder Spray AEROSOL, POWDER TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. TOLNAFTATE 1.3 g/130g 56131-759_03289a1e-75b4-4eb8-97b4-951927684265 56131-759 HUMAN OTC DRUG Luxury Antibacterial Foaming Tricolsan SOAP TOPICAL 20130430 OTC MONOGRAPH NOT FINAL part333E RD Food Service DBA Restaurant Depot TRICLOSAN 6 mg/mL 56131-774_c9cf1456-0abf-4109-bb13-a7827e4df638 56131-774 HUMAN OTC DRUG Instant Foaming Hand Sanitizer Alcohol SOAP TOPICAL 20130430 OTC MONOGRAPH NOT FINAL part333E RD Food Service DBA Restaurant Depot ALCOHOL .7 mL/mL 56136-001_69db839e-cb3a-43fd-8bea-5a1785ff900e 56136-001 HUMAN OTC DRUG Spatheraphy ALCOHOL LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. ALCOHOL 18.6 mL/30mL 56136-002_2b117ea1-6a35-4e1a-b401-c239c57e0942 56136-002 HUMAN OTC DRUG Spatheraphy ALCOHOL LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. ALCOHOL 18.6 mL/30mL 56136-003_8d145e4e-ffb6-43f1-bdf0-56389b53fede 56136-003 HUMAN OTC DRUG Spatheraphy ALCOHOL LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. ALCOHOL 18.6 mL/30mL 56136-004_47f461ac-f1b4-4045-96ef-aedbe2ee757d 56136-004 HUMAN OTC DRUG Spatheraphy ALCOHOL LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. ALCOHOL 18.6 mL/30mL 56136-005_2aa0fc56-e850-442c-86df-757bb760360d 56136-005 HUMAN OTC DRUG Spatheraphy ALCOHOL LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. ALCOHOL 18.6 mL/30mL 56136-006_8e26535d-a86a-40e6-ae87-d2e0d5bf60b7 56136-006 HUMAN OTC DRUG Spatheraphy ALCOHOL LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. ALCOHOL 18.6 mL/30mL 56136-007_614acfdd-e69a-462f-b615-06504714143f 56136-007 HUMAN OTC DRUG Spatheraphy ALCOHOL LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. ALCOHOL 18.6 mL/30mL 56136-008_25f45327-6e16-496e-910f-38eaff5b5c8e 56136-008 HUMAN OTC DRUG Spatherapy BENZALKONIUM CHLORIDE LOTION TOPICAL 20140327 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. BENZALKONIUM CHLORIDE .56 g/293g 56136-009_2358507e-43b5-41e5-9d20-80f602859390 56136-009 HUMAN OTC DRUG Spatherapy BENZALKONIUM CHLORIDE LOTION TOPICAL 20140327 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. BENZALKONIUM CHLORIDE .56 g/293g 56136-010_4251f6ff-0f25-4ec6-9093-be854c680382 56136-010 HUMAN OTC DRUG Spatherapy TRICLOSAN LOTION TOPICAL 20140327 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. TRICLOSAN .79 g/293g 56136-011_46dc299e-ccb4-4ee0-bb76-da3626ca3067 56136-011 HUMAN OTC DRUG Spatherapy BENZALKONIUM CHLORIDE LOTION TOPICAL 20140327 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. BENZALKONIUM CHLORIDE .56 g/293g 56149-001_d5be2f7d-26e8-4cb9-b551-f52368a8cb5f 56149-001 HUMAN OTC DRUG Serdaen Chlorhexidine Diacetate SOAP TOPICAL 20130601 UNAPPROVED DRUG OTHER Browne Hansen LLC CHLORHEXIDINE ACETATE 24 mg/3g 56149-002_cb80b579-2303-4261-8eba-426e54b7ffc7 56149-002 HUMAN OTC DRUG Serdaen Chlorhexidine Diacetate SOAP TOPICAL 20130601 UNAPPROVED DRUG OTHER Browne Hansen LLC CHLORHEXIDINE ACETATE 48 mg/3g 56151-681_8e9a3c3f-0150-4c99-9083-da800a9d4926 56151-681 HUMAN OTC DRUG TRUEplus diabetics intensive moisturizing TRUEplus diabetics intensive moisturizing CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 Nipro Diagnostics, Inc. ALLANTOIN; DIMETHICONE .5; 5 g/100g; g/100g 56151-682_671f2a45-0f8c-4c7a-8b0b-d13f302a4087 56151-682 HUMAN OTC DRUG TRUEplus diabetics foot care Allantoin and Dimethicone CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 Nipro Diagnostics, Inc. ALLANTOIN; DIMETHICONE .5; 5 g/100g; g/100g 56152-0010_7308121e-8388-4511-999f-72d7b3d4e59a 56152-0010 HUMAN OTC DRUG Rodan and Fields Unblemish - Acne Medicated Benzoyl Peroxide CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333 Cosmetic Enterprises BENZOYL PEROXIDE 2.5 mL/100mL 56152-0815_272dbb65-38be-43ca-8b07-19e0786e89f4 56152-0815 HUMAN OTC DRUG Rodan and Fields Essentials UVA/UVB Avobenzone, Octinoxate, Oxybenzone CREAM TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Cosmetic Enterprises Ltd. AVOBENZONE; OCTINOXATE; OXYBENZONE 2; 7.5; 3 mL/100mL; mL/100mL; mL/100mL 56152-2003_357d8586-c3a0-419d-ab98-5ba60caf5536 56152-2003 HUMAN OTC DRUG Rodan and Fields Soothe Hydrocortisone CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333 Cosmetic Enterprises Ltd. HYDROCORTISONE 1 mg/100mL 56152-2050_4eb3a032-e4fd-41e6-9e1d-ffea75bab477 56152-2050 HUMAN OTC DRUG Rodan and Fields Unblemish 1 Wash Acne Medicated Cleanser Sulfur CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333 Cosmetic Enterprises Ltd. SULFUR 3 mL/100mL 56152-4005_f1c00437-852d-485b-9334-49b84c5284cc 56152-4005 HUMAN OTC DRUG Vitaminerals Inc. Cryogel Natural Pain Relieving Menthol GEL TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333 Cosmetic Enterprises Ltd. MENTHOL 3 g/100g 56152-4006_b2567788-03bf-4c6e-95f1-d77e5d3b0f16 56152-4006 HUMAN OTC DRUG Cryogel Island Rain Natural Pain Relieving Vitaminerals Menthol GEL TOPICAL 20100914 OTC MONOGRAPH FINAL part346 Cosmetic Enterprises Ltd. MENTHOL 3 g/100g 56152-4007_82e963ef-d7dc-4213-9c0a-1562d7f0caf8 56152-4007 HUMAN OTC DRUG Natural Pain Relieving Lavender Breeze Cryogel Menthol GEL TOPICAL 20100914 OTC MONOGRAPH FINAL part341 Cosmetic Enterprises Ltd. MENTHOL 3 g/100g 56153-001_3231dd78-a47e-4f9a-801f-ed8d019011ae 56153-001 HUMAN OTC DRUG Colgate Anticavity Kit Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130510 OTC MONOGRAPH FINAL part355 Ming Fai Industrial (Shenzhen) Co. Ltd SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 56153-002_cfb31e4c-76d9-42a0-8e9d-1594390a5713 56153-002 HUMAN OTC DRUG Colgate Anticavity Kit Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130510 OTC MONOGRAPH FINAL part355 Ming Fai Industrial (Shenzhen) Co. Ltd SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 56153-003_52d06495-b04e-4063-8573-065fcab81f23 56153-003 HUMAN OTC DRUG Crest Anticavity Kit Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120522 OTC MONOGRAPH FINAL part355 Ming Fai Industrial (Shenzhen) Co. Ltd SODIUM FLUORIDE 2.43 mg/g 57236-0001_fea32d30-0d9b-48ac-be18-989f3fb18d34 57236-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Saginaw Weldilng Supply Company OXYGEN 99 L/100L 57237-002_22c46c52-dcb8-4fb9-9ecf-d92c60bbfe2c 57237-002 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20070919 ANDA ANDA078164 Citron Pharma LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 57237-003_d6d64170-8799-48a0-b98b-98133eefa87b 57237-003 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Citron Pharma LLC FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 57237-004_d6d64170-8799-48a0-b98b-98133eefa87b 57237-004 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Citron Pharma LLC FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 57237-005_d6d64170-8799-48a0-b98b-98133eefa87b 57237-005 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Citron Pharma LLC FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 57237-006_d6d64170-8799-48a0-b98b-98133eefa87b 57237-006 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Citron Pharma LLC FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 57237-007_ffe98c10-1ca1-4c8d-b5e4-4ec0230a4f33 57237-007 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Citron Pharma LLC MIRTAZAPINE 7.5 mg/1 57237-008_ffe98c10-1ca1-4c8d-b5e4-4ec0230a4f33 57237-008 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Citron Pharma LLC MIRTAZAPINE 15 mg/1 57237-009_ffe98c10-1ca1-4c8d-b5e4-4ec0230a4f33 57237-009 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Citron Pharma LLC MIRTAZAPINE 30 mg/1 57237-010_ffe98c10-1ca1-4c8d-b5e4-4ec0230a4f33 57237-010 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Citron Pharma LLC MIRTAZAPINE 45 mg/1 57237-011_66fb256e-ace9-48b0-8a96-99fdd2a1c03b 57237-011 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20051208 ANDA ANDA077376 Citron Pharma LLC MIRTAZAPINE 15 mg/1 57237-012_66fb256e-ace9-48b0-8a96-99fdd2a1c03b 57237-012 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20051208 ANDA ANDA077376 Citron Pharma LLC MIRTAZAPINE 30 mg/1 57237-013_66fb256e-ace9-48b0-8a96-99fdd2a1c03b 57237-013 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20060228 ANDA ANDA077376 Citron Pharma LLC MIRTAZAPINE 45 mg/1 57237-014_205a7938-8723-47d1-a6e4-ca1072df23d7 57237-014 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130430 ANDA ANDA202433 Citron Pharma LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 57237-017_43a9b75d-31c5-48b1-8564-cc7efe3e0e34 57237-017 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Citron Pharma LLC DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57237-018_43a9b75d-31c5-48b1-8564-cc7efe3e0e34 57237-018 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Citron Pharma LLC DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57237-019_43a9b75d-31c5-48b1-8564-cc7efe3e0e34 57237-019 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Citron Pharma LLC DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57237-020_deb683b9-544c-4502-bc0b-69af6161ab73 57237-020 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20071018 ANDA ANDA077537 Citron Pharma LLC GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 57237-021_deb683b9-544c-4502-bc0b-69af6161ab73 57237-021 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20071018 ANDA ANDA077537 Citron Pharma LLC GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 57237-022_deb683b9-544c-4502-bc0b-69af6161ab73 57237-022 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20071018 ANDA ANDA077537 Citron Pharma LLC GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 57237-023_372af566-d6ec-446f-88db-0b4cc83b577f 57237-023 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Citron Pharma LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 57237-024_372af566-d6ec-446f-88db-0b4cc83b577f 57237-024 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Citron Pharma LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 57237-025_372af566-d6ec-446f-88db-0b4cc83b577f 57237-025 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Citron Pharma LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 57237-026_978a5492-0c73-42ca-a15b-bba3eb70b41e 57237-026 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20090709 ANDA ANDA079245 Citron Pharma LLC FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 57237-027_978a5492-0c73-42ca-a15b-bba3eb70b41e 57237-027 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20090709 ANDA ANDA079245 Citron Pharma LLC FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 57237-028_bb7733f8-6aad-4273-84a0-ef472630203f 57237-028 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Citron Pharma LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 57237-029_bb7733f8-6aad-4273-84a0-ef472630203f 57237-029 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Citron Pharma LLC AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 57237-030_bbe590a0-4196-4885-b679-cc1833af567f 57237-030 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Citron Pharma LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 57237-031_bbe590a0-4196-4885-b679-cc1833af567f 57237-031 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Citron Pharma LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 57237-032_554239db-69fe-405a-910a-d9f9e3f8b6ed 57237-032 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Citron Pharma LLC AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 57237-033_554239db-69fe-405a-910a-d9f9e3f8b6ed 57237-033 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Citron Pharma LLC AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 57237-034_d7fac9cc-30e1-4762-a01b-04f1bd3b2a56 57237-034 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20070130 ANDA ANDA065381 Citron Pharma LLC CEFPROZIL 125 mg/5mL 57237-035_d7fac9cc-30e1-4762-a01b-04f1bd3b2a56 57237-035 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20070130 ANDA ANDA065381 Citron Pharma LLC CEFPROZIL 250 mg/5mL 57237-036_af24a86f-8072-49a6-94ec-2f17fe81812b 57237-036 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20070524 ANDA ANDA065340 Citron Pharma LLC CEFPROZIL 250 mg/1 57237-037_af24a86f-8072-49a6-94ec-2f17fe81812b 57237-037 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20070524 ANDA ANDA065340 Citron Pharma LLC CEFPROZIL 500 mg/1 57237-040_eaaa0085-d698-4b46-a7cf-84959c17e6a8 57237-040 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 Citron Pharma LLC PENICILLIN V POTASSIUM 250 mg/1 57237-041_eaaa0085-d698-4b46-a7cf-84959c17e6a8 57237-041 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 Citron Pharma LLC PENICILLIN V POTASSIUM 500 mg/1 57237-042_8d1645c0-fd03-4992-9372-98026a26b3af 57237-042 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Citron Pharma LLC VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 57237-043_8d1645c0-fd03-4992-9372-98026a26b3af 57237-043 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Citron Pharma LLC VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 57237-044_0c4db97f-f4c9-4cac-9f12-9db1d967ebeb 57237-044 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20120725 ANDA ANDA065489 Citron Pharma LLC CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 57237-045_0c4db97f-f4c9-4cac-9f12-9db1d967ebeb 57237-045 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20120725 ANDA ANDA065489 Citron Pharma LLC CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 57237-046_ab639046-7349-4cc1-8eb1-2728aca016c4 57237-046 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110421 20160731 ANDA ANDA090554 Citron Pharma LLC DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 57237-047_ab639046-7349-4cc1-8eb1-2728aca016c4 57237-047 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110421 ANDA ANDA090554 Citron Pharma LLC DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 57237-048_ab639046-7349-4cc1-8eb1-2728aca016c4 57237-048 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110421 ANDA ANDA090554 Citron Pharma LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 57237-049_a0dc1a93-b7b8-4179-8ea7-ceecbe1ef243 57237-049 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20110329 ANDA ANDA090957 Citron Pharma LLC GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 57237-050_a0dc1a93-b7b8-4179-8ea7-ceecbe1ef243 57237-050 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20110329 ANDA ANDA090957 Citron Pharma LLC GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 57237-051_a0dc1a93-b7b8-4179-8ea7-ceecbe1ef243 57237-051 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20110329 ANDA ANDA090957 Citron Pharma LLC GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 57237-052_4f52a47a-4fd4-46e4-9292-d53943751887 57237-052 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Citron Pharma LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 57237-053_4f52a47a-4fd4-46e4-9292-d53943751887 57237-053 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Citron Pharma LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 57237-054_4f52a47a-4fd4-46e4-9292-d53943751887 57237-054 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Citron Pharma LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 57237-055_4f52a47a-4fd4-46e4-9292-d53943751887 57237-055 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Citron Pharma LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 57237-056_4f52a47a-4fd4-46e4-9292-d53943751887 57237-056 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Citron Pharma LLC LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 57237-057_4f52a47a-4fd4-46e4-9292-d53943751887 57237-057 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Citron Pharma LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 57237-058_6cb67c0d-da3a-4c44-b3b3-438f7b934631 57237-058 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20060329 ANDA ANDA065308 Citron Pharma LLC CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 57237-059_6cb67c0d-da3a-4c44-b3b3-438f7b934631 57237-059 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20060329 ANDA ANDA065308 Citron Pharma LLC CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 57237-061_01b88593-99d3-4dd6-a7b6-5438c15bd7b7 57237-061 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20131105 ANDA ANDA203687 Citron Pharma LLC FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 57237-062_9cb6a9f1-f7a6-46be-9b2b-8f228c821b4d 57237-062 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20071030 ANDA ANDA078341 Citron Pharma LLC FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 57237-066_7138748e-64e4-4650-a555-cbc5280e2109 57237-066 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Citron Pharma LLC LEVOFLOXACIN 250 mg/1 57237-067_7138748e-64e4-4650-a555-cbc5280e2109 57237-067 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Citron Pharma LLC LEVOFLOXACIN 500 mg/1 57237-068_7138748e-64e4-4650-a555-cbc5280e2109 57237-068 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Citron Pharma LLC LEVOFLOXACIN 750 mg/1 57237-069_2ef3ec1b-5a02-49c6-b389-a08710e0d429 57237-069 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Citron Pharma LLC OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 57237-070_2ef3ec1b-5a02-49c6-b389-a08710e0d429 57237-070 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Citron Pharma LLC OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 57237-071_2ef3ec1b-5a02-49c6-b389-a08710e0d429 57237-071 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Citron Pharma LLC OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 57237-072_2ef3ec1b-5a02-49c6-b389-a08710e0d429 57237-072 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Citron Pharma LLC OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 57237-073_2ef3ec1b-5a02-49c6-b389-a08710e0d429 57237-073 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Citron Pharma LLC OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 57237-074_2ef3ec1b-5a02-49c6-b389-a08710e0d429 57237-074 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Citron Pharma LLC OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 57237-075_90e0e508-75f7-4c8b-bb38-898aa4c531c3 57237-075 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Citron Pharma LLC ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 57237-076_90e0e508-75f7-4c8b-bb38-898aa4c531c3 57237-076 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Citron Pharma LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 57237-077_eb74425c-c635-4d99-8e98-e63e7359fb89 57237-077 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 Citron Pharma LLC ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 57237-078_eb74425c-c635-4d99-8e98-e63e7359fb89 57237-078 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 Citron Pharma LLC ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 57237-079_4c92655c-aac0-4d4a-9d5f-70fde72622f3 57237-079 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Citron Pharma LLC QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 57237-080_4c92655c-aac0-4d4a-9d5f-70fde72622f3 57237-080 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Citron Pharma LLC QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 57237-081_4c92655c-aac0-4d4a-9d5f-70fde72622f3 57237-081 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Citron Pharma LLC QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 57237-082_4c92655c-aac0-4d4a-9d5f-70fde72622f3 57237-082 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Citron Pharma LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 57237-083_4c92655c-aac0-4d4a-9d5f-70fde72622f3 57237-083 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Citron Pharma LLC QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 57237-084_4c92655c-aac0-4d4a-9d5f-70fde72622f3 57237-084 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Citron Pharma LLC QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 57237-085_2337e102-8df0-4e7f-81d8-5cb86cd48674 57237-085 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA203062 Citron Pharma LLC RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 57237-086_2337e102-8df0-4e7f-81d8-5cb86cd48674 57237-086 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA203062 Citron Pharma LLC RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 57237-087_222f77ff-d3f7-40f9-989c-e5902f44ef1e 57237-087 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20121231 ANDA ANDA202490 Citron Pharma LLC RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 57237-088_222f77ff-d3f7-40f9-989c-e5902f44ef1e 57237-088 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20121231 ANDA ANDA202490 Citron Pharma LLC RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 57237-089_0107d19a-b43a-4a36-8b8c-4dfc247630e9 57237-089 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070612 ANDA ANDA078438 Citron Pharma LLC TRANDOLAPRIL 1 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 57237-090_0107d19a-b43a-4a36-8b8c-4dfc247630e9 57237-090 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070612 ANDA ANDA078438 Citron Pharma LLC TRANDOLAPRIL 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 57237-091_0107d19a-b43a-4a36-8b8c-4dfc247630e9 57237-091 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070612 ANDA ANDA078438 Citron Pharma LLC TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 57237-092_cc2aab5d-a9ff-4277-ab33-aa1f5aeffa95 57237-092 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA090432 Citron Pharma LLC ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57237-093_cc2aab5d-a9ff-4277-ab33-aa1f5aeffa95 57237-093 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA090432 Citron Pharma LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57237-094_cc2aab5d-a9ff-4277-ab33-aa1f5aeffa95 57237-094 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA090432 Citron Pharma LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57237-095_9cd35bfb-bdfc-4e5e-8da7-e03457a3637f 57237-095 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate SOLUTION ORAL 20120403 ANDA ANDA079062 Citron Pharma LLC ESCITALOPRAM OXALATE 5 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57237-096_74c99fd8-16d1-4d2c-9158-42ff5eed2b7c 57237-096 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20070125 ANDA ANDA065352 Citron Pharma LLC CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 57237-097_6e4111d3-f11b-403c-b340-b216022709df 57237-097 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20130425 ANDA ANDA065349 Citron Pharma LLC CEFADROXIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 57237-098_6e4111d3-f11b-403c-b340-b216022709df 57237-098 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20130425 ANDA ANDA065349 Citron Pharma LLC CEFADROXIL 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 57237-099_a5594006-8e37-459e-8e85-7e2a83d7a57e 57237-099 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20080107 ANDA ANDA065434 Citron Pharma LLC CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 57237-100_30b2b576-4939-4903-be59-dbd1624a5eb6 57237-100 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Citron Pharma LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 57237-101_30b2b576-4939-4903-be59-dbd1624a5eb6 57237-101 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Citron Pharma LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 57237-102_30b2b576-4939-4903-be59-dbd1624a5eb6 57237-102 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Citron Pharma LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 57237-103_0397b504-6335-40ad-9cca-372d42bb6cc0 57237-103 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Citron Pharma LLC DOXYCYCLINE HYCLATE 50 mg/1 57237-104_0397b504-6335-40ad-9cca-372d42bb6cc0 57237-104 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Citron Pharma LLC DOXYCYCLINE HYCLATE 100 mg/1 57237-105_8432ad94-27b5-48ce-b0e0-ec36df49fb04 57237-105 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 Citron Pharma LLC DOXYCYCLINE HYCLATE 100 mg/1 57237-106_ab639046-7349-4cc1-8eb1-2728aca016c4 57237-106 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141024 ANDA ANDA090554 Citron Pharma LLC DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 57237-108_f5f56c59-04d5-4c5d-9441-5a93d3bdec82 57237-108 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130117 ANDA ANDA203417 Citron Pharma LLC FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 57237-109_f5f56c59-04d5-4c5d-9441-5a93d3bdec82 57237-109 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130117 ANDA ANDA203417 Citron Pharma LLC FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 57237-110_f5f56c59-04d5-4c5d-9441-5a93d3bdec82 57237-110 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130117 ANDA ANDA203417 Citron Pharma LLC FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 57240-2003_603e158b-23cb-4443-beda-8e36c6b390bf 57240-2003 HUMAN OTC DRUG Zippity Doos for Children Rosemary Oil SHAMPOO TOPICAL 20100301 UNAPPROVED HOMEOPATHIC Laurus Enterprises, LLC ROSEMARY OIL 2.49 mg/mL 57240-2010_61510e94-444e-4bf0-8676-3ac21616c506 57240-2010 HUMAN OTC DRUG Zippity Doos CONDITIONER FOR CHILDREN Rosemary Oil LIQUID TOPICAL 20100301 UNAPPROVED HOMEOPATHIC Laurus Enterprises, LLC ROSEMARY OIL 2.49 mg/mL 57240-2027_9bacf466-7af6-4b04-a9fe-656101bef374 57240-2027 HUMAN OTC DRUG Zippity Doos STYLING FOR CHILDREN Rosemary GEL TOPICAL 20100301 UNAPPROVED HOMEOPATHIC Laurus Enterprises, LLC ROSEMARY .023 mg/mL 57240-2034_685a3436-9940-4254-b133-295d0d37d600 57240-2034 HUMAN OTC DRUG Zippity Doos LEAVE-IN DETANGLER FOR CHILDREN Rosemary Oil SPRAY TOPICAL 20100301 UNAPPROVED HOMEOPATHIC Laurus Enterprises, LLC ROSEMARY OIL 2.45 mg/mL 57240-2041_394d0c56-a4b2-4acd-8977-ef591a007405 57240-2041 HUMAN OTC DRUG Zippity Doos SHIELD Rosemary LIQUID TOPICAL 20100301 UNAPPROVED HOMEOPATHIC Laurus Enterprises, LLC ROSEMARY 2.49 mg/mL 57243-016_dca82419-a23f-4cb0-836c-0172844e76c5 57243-016 HUMAN OTC DRUG CVP Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Salado Sales, Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 57243-055_82be3ad7-a459-4eba-9ef0-fedc719001ac 57243-055 HUMAN OTC DRUG CVP Antibacterial Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Salado Sales, Inc. BENZALKONIUM CHLORIDE .115 g/1 57243-157_f2070a7e-58e1-44c5-8f45-01ed4029047c 57243-157 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20060210 OTC MONOGRAPH FINAL part343 Salado Sales, Inc. ASPIRIN 325 mg/1 57243-159_8117a31b-513a-4168-844a-619fa4d87223 57243-159 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 57243-175_eb43deae-e6fb-458a-a589-4c23caf5a3dd 57243-175 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen TABLET ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN 500 mg/1 57243-189_84a8824c-0a60-45c5-a4ed-e22f00081b09 57243-189 HUMAN OTC DRUG Sleep Diphenhydramine HCl TABLET ORAL 19900410 OTC MONOGRAPH FINAL part341 Salado Sales, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 57243-190_f851dae1-ac6e-465a-b914-f379f9a40c42 57243-190 HUMAN OTC DRUG Complete Allergy Medicine Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part336 Salado Sales, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 57243-226_83efb2ca-1313-4c3f-8d1d-a8cc04099cc9 57243-226 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19921121 OTC MONOGRAPH FINAL part340 Salado Sales, Inc. CAFFEINE 200 mg/1 57243-235_dd061e81-d9b1-4121-8066-bb2790bd86f0 57243-235 HUMAN OTC DRUG Extra Strength Pain Reliever PM Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 57243-291_4e0a08e0-8c03-4ef0-a4b8-944c73d42711 57243-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 Salado Sales, Inc. IBUPROFEN 200 mg/1 57243-403_d9671300-a0a4-433c-bfe7-a0a0e8ed0a8b 57243-403 HUMAN OTC DRUG Less Drowsy Formula Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 Salado Sales, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 57243-453_3c6953d1-2162-4db1-8d33-dcb3b1b13102 57243-453 HUMAN OTC DRUG Non-Drowsy Suphedrine PE Congestion Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 Salado Sales, Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 57243-466_97038923-5b66-453b-99cf-4f8432804308 57243-466 HUMAN OTC DRUG Sinus Congestion and Pain Acetaminophen and Phenylephrine HCl TABLET ORAL 20050726 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN 325 mg/1 57243-501_7553f9e2-49b9-449f-ad07-b19d991a758f 57243-501 HUMAN OTC DRUG Nite-Time COLD/FLU ORIGINAL ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20120116 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 57243-502_61a20693-a236-424d-9cf0-768504d256f3 57243-502 HUMAN OTC DRUG Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20120131 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 57243-503_713995d8-b245-45dc-b18c-612bff78df7c 57243-503 HUMAN OTC DRUG TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20120101 OTC MONOGRAPH FINAL part341 Salado Sales, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 57243-506_056eb57c-a330-4683-8e95-9375f460c1f6 57243-506 HUMAN OTC DRUG Daytime Non-Drowsy COLD/FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20120905 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 57243-534_21f7d628-495f-432d-b1ae-89508db37810 57243-534 HUMAN OTC DRUG DayTime Multi-Symptom Flu Cold Medicine Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20070919 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 57243-535_b16ca618-ecac-47ad-8e6d-4994c31078bb 57243-535 HUMAN OTC DRUG NightTime Liquid Caps Multi-Symptom Flu Cold Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20070910 OTC MONOGRAPH NOT FINAL part341 Salado Sales, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 57243-620_6ad2411e-d67a-4274-9946-f191bf861856 57243-620 HUMAN OTC DRUG Maximum Strength Heartburn Relief 150 Ranitidine TABLET ORAL 20130615 ANDA ANDA200536 Salado Sales, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 57243-641_8f102641-d6a4-42f5-bef5-968e10998d6b 57243-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140904 OTC MONOGRAPH NOT FINAL part333A Salado Sales, Inc BENZALKONIUM CHLORIDE .999 mg/mL 57261-786_07478020-5b89-3b67-e054-00144ff88e88 57261-786 HUMAN OTC DRUG Dynamiclear ORO glycerin SWAB TOPICAL 20141111 OTC MONOGRAPH NOT FINAL part347 Sci-chem International Pty Ltd GLYCERIN 200 mg/.5mL 57285-100_7aff6e22-67f3-408c-adcc-e2978f1c1508 57285-100 HUMAN OTC DRUG Anti Itch Balm Peppermint Oil OINTMENT TOPICAL 20130329 UNAPPROVED DRUG OTHER US ORGANIC GROUP CORP PEPPERMINT OIL .0952 g/28g 57287-100_6a4c2223-05a1-46e1-bcf5-59ea4191ead4 57287-100 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20130311 UNAPPROVED MEDICAL GAS Jernigan Healthcare, Inc. OXYGEN 99 L/100L 57297-201_eec0f096-bdd2-4977-9e6b-425219736c83 57297-201 HUMAN PRESCRIPTION DRUG SUPRAX cefixime TABLET ORAL 20080401 ANDA ANDA065130 LUPIN LIMITED CEFIXIME 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 57297-203_eec0f096-bdd2-4977-9e6b-425219736c83 57297-203 HUMAN PRESCRIPTION DRUG SUPRAX cefixime TABLET, CHEWABLE ORAL 20121205 ANDA ANDA065380 LUPIN LIMITED CEFIXIME 100 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 57297-205_eec0f096-bdd2-4977-9e6b-425219736c83 57297-205 HUMAN PRESCRIPTION DRUG SUPRAX cefixime TABLET, CHEWABLE ORAL 20121205 ANDA ANDA065380 LUPIN LIMITED CEFIXIME 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 57297-206_eec0f096-bdd2-4977-9e6b-425219736c83 57297-206 HUMAN PRESCRIPTION DRUG SUPRAX cefixime POWDER, FOR SUSPENSION ORAL 20070601 ANDA ANDA065355 LUPIN LIMITED CEFIXIME 200 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 57297-207_eec0f096-bdd2-4977-9e6b-425219736c83 57297-207 HUMAN PRESCRIPTION DRUG SUPRAX cefixime POWDER, FOR SUSPENSION ORAL 20130315 NDA NDA202091 LUPIN LIMITED CEFIXIME 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 57297-208_eec0f096-bdd2-4977-9e6b-425219736c83 57297-208 HUMAN PRESCRIPTION DRUG SUPRAX cefixime CAPSULE ORAL 20130315 NDA NDA203195 LUPIN LIMITED CEFIXIME 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 57319-065_580b36d2-1400-4096-aff1-cbc1f6d0ad4c 57319-065 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC 19960726 ANDA ANDA040069 Phoenix Pharmaceutical, Inc. DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 57319-307_2a1d77e9-c706-4d9b-9745-e93ef4919c8a 57319-307 HUMAN PRESCRIPTION DRUG NPD Neomycin sulfate, Polymyxin B Sulfate, and Dexamethasone OINTMENT OPHTHALMIC 19940725 ANDA ANDA064063 Phoenix Pharmaceutical, Inc. DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 57319-343_f7504b22-2d9e-4e2c-a308-1469bd5a1bab 57319-343 HUMAN PRESCRIPTION DRUG Triple Antibiotic Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 19951030 ANDA ANDA064064 Phoenix Pharmaceutical, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 10000 [USP'U]/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] 57319-344_8b45f06d-ad0b-447a-ab1d-14cab8ca4043 57319-344 HUMAN PRESCRIPTION DRUG Triple Antibiotic HC Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone OINTMENT OPHTHALMIC 19951030 ANDA ANDA064068 Phoenix Pharmaceutical, Inc. BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 10; 3.5; 10000 [USP'U]/g; mg/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 57319-347_61b2cb3a-9512-48a0-a01d-2cacebeae7fe 57319-347 HUMAN PRESCRIPTION DRUG Neomycin Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19950913 ANDA ANDA064135 Phoenix Pharmaceutical, Inc. DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 57319-411_9f97ed43-c136-4e39-8a17-77aa234066f8 57319-411 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20100831 OTC MONOGRAPH FINAL part349 Phoenix/Clipper WATER 99.05 mL/100mL 57329-010_b9cbc519-8615-43a5-939e-0e2763e2d5ee 57329-010 HUMAN OTC DRUG THERAFREEZE MENTHOL GEL TOPICAL 20130808 OTC MONOGRAPH FINAL part341 Astrum Pharma MENTHOL 60 mg/mL 57337-000_0d26bd16-503b-49f5-a459-f48483d021b5 57337-000 HUMAN OTC DRUG XtraCare instant Hand Sanitizer Original ALCOHOL LIQUID TOPICAL 20130207 OTC MONOGRAPH FINAL part333E Rejoice International ALCOHOL 62 mL/100mL 57337-001_37a8e424-f63f-4cc9-bca4-c5ccf681a9dc 57337-001 HUMAN OTC DRUG XtraCare instant Hand Sanitizer ALCOHOL SPRAY TOPICAL 20130208 OTC MONOGRAPH FINAL part333E Rejoice International ALCOHOL 62 mL/100mL 57337-002_96d9a53e-e345-4716-b1d2-9f87276ab833 57337-002 HUMAN OTC DRUG XtraCare instant Hand Sanitizer Aloe Vera ALCOHOL LIQUID TOPICAL 20130208 OTC MONOGRAPH FINAL part333E Rejoice International ALCOHOL 62 mL/100mL 57337-003_f3d5c3f4-d347-41fe-836f-81ec8e750ff0 57337-003 HUMAN OTC DRUG XtraCare instant Hand Sanitizer Cocoa Butter ALCOHOL LIQUID TOPICAL 20130208 OTC MONOGRAPH FINAL part333E Rejoice International ALCOHOL 62 mL/100mL 57337-012_a9f4454e-4415-4de2-8f44-73b9d418e5c4 57337-012 HUMAN OTC DRUG Instant Hand Sanitizer Aloe Vera Ethyl Alcohol GEL TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. ALCOHOL 146 mL/236mL 57337-013_ac96fab0-e97b-4051-9b3e-3ba26f3d5aae 57337-013 HUMAN OTC DRUG Instant Hand Sanitizer - Ice Clear Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. ALCOHOL 37 mL/60mL 57337-014_5a245e41-a03a-4e93-8f9f-c8d1cb2eaf54 57337-014 HUMAN OTC DRUG Instant Hand Sanitizer - Clear Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. ALCOHOL 147 mL/237mL 57337-015_2bc1bbb6-974d-4c5c-9c09-a2cc48150d49 57337-015 HUMAN OTC DRUG Instant Hand Sanitizer - Cocoa Butter Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. ALCOHOL 147 mL/237mL 57337-016_9ec5a404-bf2a-4f23-bbd1-6834a74767fb 57337-016 HUMAN OTC DRUG Liquid Hand Cleanse Triclosan GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. TRICLOSAN 10 mg/500mg 57337-017_cd9b5377-d1b7-4489-a177-e063e22f33fd 57337-017 HUMAN OTC DRUG Instant Hand Sanitizer - Original Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. ALCOHOL 33 mL/53mL 57337-018_08311c94-3638-4e1f-8ab1-0758a514efa8 57337-018 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. ALCOHOL 6 mL/10mL 57337-020_048b18ef-f03e-4be7-af8b-58f69460ae35 57337-020 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Mountain Spring Triclosan SOAP TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. TRICLOSAN 3.3 mg/221mL 57337-021_12631f4d-dd29-4a3f-b2dc-d4969a093f8b 57337-021 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Original Triclosan SOAP TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. TRICLOSAN 3.3 mg/221mL 57337-022_79cb1808-3dc2-40bf-a7cb-136ab4bf8bfb 57337-022 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Original Triclosan SOAP TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. TRICLOSAN 6.6 1/443mL 57337-023_5127744e-1fdc-4f23-bff6-695aa38b989e 57337-023 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Strawberry Pomegranate Triclosan SOAP TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. TRICLOSAN 3.3 mg/221mL 57337-024_f4c80e21-65c0-48e1-916e-35efffa70a2e 57337-024 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse Coconut and Shea Butter PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H Rejoice International Inc. PYRITHIONE ZINC 20 mg/400mg 57337-025_e97c3200-3fc9-43fa-a4c1-fdeb12914ebe 57337-025 HUMAN OTC DRUG XtraCare Anti-Dandruff Conditioner Coconut and Shea Butter PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H Rejoice International Inc. PYRITHIONE ZINC 20 mg/400mg 57337-026_1899b545-beb0-491d-ba9e-8758006ef10e 57337-026 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse mint and eucalyptus PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H Rejoice International Inc. PYRITHIONE ZINC 20 mg/400mg 57337-027_922fb746-e59e-4b04-a3cc-e1aa3e01923e 57337-027 HUMAN OTC DRUG XtraCare Anti-Dandruff Conditioner mint and eucalyptus PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H Rejoice International Inc. PYRITHIONE ZINC 20 mg/400mg 57337-028_30096768-5e29-4590-9f64-9d844882a3fc 57337-028 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse for normal hair PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H Rejoice International Inc. PYRITHIONE ZINC 20 mg/400mg 57337-029_72a352ef-4bf0-4df9-97e7-b3018bbdc22a 57337-029 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse for sensitive hair PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H Rejoice International Inc. PYRITHIONE ZINC 20 mg/400mg 57337-030_4f825e24-1934-41d0-bb3f-f7881a537400 57337-030 HUMAN OTC DRUG Acne Body Wash Salicylic Acid GEL TOPICAL 20131118 OTC MONOGRAPH FINAL part333D Rejoice International SALICYLIC ACID 7 mg/354mg 57337-031_7dbca551-7304-4523-ad72-e3f7276790c9 57337-031 HUMAN OTC DRUG Oil-Free Foaming Acne Wash Salicylic Acid GEL TOPICAL 20131118 OTC MONOGRAPH FINAL part333D Rejoice International SALICYLIC ACID 3 g/150g 57337-032_f0209564-80e1-4a5b-8e71-dd0f2002824e 57337-032 HUMAN OTC DRUG Oil-Free Foaming Acne Wash Tea Tree Oil Salicylic Acid GEL TOPICAL 20131120 OTC MONOGRAPH FINAL part333D Rejoice International SALICYLIC ACID 3 g/150g 57337-033_73a58c01-f979-412f-b1a1-95ec0a90e723 57337-033 HUMAN OTC DRUG Oil-Free Foaming Acne Wash Facial Cleanser Grapefruit Salicylic Acid GEL TOPICAL 20131121 OTC MONOGRAPH FINAL part333D Rejoice International SALICYLIC ACID 4 mg/177mg 57337-034_36c99b62-78f2-4854-949d-e8d828928c9c 57337-034 HUMAN OTC DRUG Oil-Free Foaming Acne Wash Facial Cleanser Tea Tree Oil Salicylic Acid GEL TOPICAL 20131121 OTC MONOGRAPH FINAL part333D Rejoice International SALICYLIC ACID 4 mg/177mg 57337-035_7826d2dc-7935-4752-aa56-1f253eded404 57337-035 HUMAN OTC DRUG XtraCare Deep Cleaning Astringent Salicylic Acid GEL TOPICAL 20131126 OTC MONOGRAPH FINAL part333D Rejoice International SALICYLIC ACID 5 mg/237mg 57337-036_35e5c7d9-ccc4-4880-9c18-a392e6fe76b6 57337-036 HUMAN OTC DRUG XtraCare Foaming Facial Cleanser Triclosan GEL TOPICAL 20131126 OTC MONOGRAPH NOT FINAL part333A Rejoice International TRICLOSAN 1 mg/237mg 57337-037_24af7c19-38e2-461a-8b18-5887d237fa08 57337-037 HUMAN OTC DRUG XtraCare Skin Relief Oatmeal Daily Moisturizing Dimethicone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part347 Rejoice International DIMETHICONE 5 mg/354mg 57337-038_7424ddf3-504b-45a7-816c-d78bdc0ff239 57337-038 HUMAN OTC DRUG XtraCare with cooling action Oatmeal Skin Relief Calmin Dimethicone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part347 Rejoice International DIMETHICONE 5 mg/354mg 57337-039_379985e3-ff56-40a9-b145-8bc5adbd92aa 57337-039 HUMAN OTC DRUG XtraCare Creamy Petroleum Jelly Cocoa Butter Enriched Petroleum CREAM TOPICAL 20140124 OTC MONOGRAPH FINAL part347 Rejoice International PETROLATUM 59 g/198g 57337-040_1e4649e1-7bbc-4d75-8a47-8ec6c409a113 57337-040 HUMAN OTC DRUG XtraCare Creamy Petroleum Jelly Vitamin E enriched Petrolatum CREAM TOPICAL 20140124 OTC MONOGRAPH FINAL part347 Rejoice International PETROLATUM 59 g/198g 57337-041_44ea82bf-551e-4cd8-ba23-81804b6f8199 57337-041 HUMAN OTC DRUG XtraCare Dry Fresh Invisible Solid Aluminum Chlorohydrate CREAM TOPICAL 20140124 OTC MONOGRAPH FINAL part350 Rejoice International ALUMINUM CHLOROHYDRATE 11 g/57g 57337-042_1fd9d74e-e977-440b-bd9f-0fe1bee6582c 57337-042 HUMAN OTC DRUG XtraCare Invisible Solid Lady Stick Powder Fresh Aluminum Chlorohydrate CREAM TOPICAL 20140124 OTC MONOGRAPH FINAL part350 Rejoice International ALUMINUM CHLOROHYDRATE 11 g/57g 57337-043_6ac53718-6d24-4d8a-ac64-997efa2c750b 57337-043 HUMAN OTC DRUG XtraCare Hand Sanitizer Moisturize with Vitamin E Ethyl Alcohol GEL TOPICAL 20140124 OTC MONOGRAPH NOT FINAL part333E Rejoice International ALCOHOL 146 g/236g 57337-044_32d6c7d3-0d3d-4a91-a296-1392a56b80cd 57337-044 HUMAN OTC DRUG XtraCare Hand Sanitizer Moisurize with Vitamin E and Aloe Ethyl Alcohol GEL TOPICAL 20140124 OTC MONOGRAPH NOT FINAL part333E Rejoice International ALCOHOL 146 g/236g 57337-045_0f600ad7-8573-4cca-9a6c-2549c683ca96 57337-045 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower Benzalkonium Chloride LIQUID TOPICAL 20140124 OTC MONOGRAPH NOT FINAL part333A Rejoice International BENZALKONIUM CHLORIDE .5 g/444g 57337-046_1971ba1c-5cc6-44c7-92b7-d9827699085c 57337-046 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Refill Wild Berry Blast Benzalkonium Chloride SOAP TOPICAL 20140128 OTC MONOGRAPH NOT FINAL part333A Rejoice International BENZALKONIUM CHLORIDE .5 g/444g 57337-047_c88fb5d4-673d-4dec-bae5-cc46307ad054 57337-047 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower Benzalkonium Chloride SOAP TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A Rejoice International BENZALKONIUM CHLORIDE .2 g/221g 57337-048_63f0c7f6-0e89-4a70-8fdb-a749f97d08cd 57337-048 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Wild Berry Blast Benzalkonium Chloride SOAP TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A Rejoice International BENZALKONIUM CHLORIDE .2 g/221g 57337-049_fed4acc5-4e41-4188-b2ff-01280ea0778c 57337-049 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Pink Cherry Blossom Benzalkonium Chloride SOAP TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A Rejoice International BENZALKONIUM CHLORIDE .2 g/221g 57337-050_782079ab-af66-4ce1-a6d8-b2a0ddb7f3d1 57337-050 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry Blossom Benzalkonium Chloride SOAP TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A Rejoice International BENZALKONIUM CHLORIDE .5 g/444g 57337-051_a99339b7-9a88-4021-88a5-ebbe7ad1a56a 57337-051 HUMAN OTC DRUG XtraCare Vaporizing Chest Rub Camphor, Menthol GEL TOPICAL 20140130 OTC MONOGRAPH FINAL part341 Rejoice International CAMPHOR (NATURAL); MENTHOL 5; 1 g/113g; g/113g 57337-052_6b89bcf3-23b6-4d4d-945d-5d2aba6c6001 57337-052 HUMAN OTC DRUG XtraCare Ice Cold Topical Analgesic Gel Menthol GEL TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part348 Rejoice International MENTHOL 3 g/227g 57337-053_c3d3a197-dc75-4905-96eb-04fa69b499bb 57337-053 HUMAN OTC DRUG XtraCare Dandruff Hair Wash Salicylic Acid SHAMPOO TOPICAL 20140205 OTC MONOGRAPH FINAL part358H Rejoice International SALICYLIC ACID 10 g/325g 57337-054_abd593b8-47f4-4f3e-a34a-29770632d7f1 57337-054 HUMAN OTC DRUG XtraCare Skin Relief Oatmeal Daily Moisturizing Dimethicone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part347 Rejoice International DIMETHICONE 3 g/227g 57337-055_24d3cab6-04ef-4179-9b9f-c4d0b8cd222b 57337-055 HUMAN OTC DRUG XtraCare with cooling action Oatmeal Skin Relief Calmin Dimethicone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part347 Rejoice International DIMETHICONE 3 g/227g 57337-056_c974d446-6853-4b42-ba6c-a9f2c7a559f8 57337-056 HUMAN OTC DRUG XtraCare Antifungal Foot Tolnaftate SPRAY TOPICAL 20140211 OTC MONOGRAPH FINAL part333C Rejoice International TOLNAFTATE 1 g/100g 57337-057_1715ef4a-472c-41b7-ac2b-3dc5ce66bf86 57337-057 HUMAN OTC DRUG XtraCare Foaming Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333E Rejoice International BENZALKONIUM CHLORIDE 3 g/207g 57337-058_d683a1e2-7f07-4f34-b527-a4bd8c10c412 57337-058 HUMAN OTC DRUG XtraCare Instant Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333E Rejoice International ALCOHOL 37 g/60g 57337-059_568b03d3-e2c9-40ee-afb3-3e23b2fe4675 57337-059 HUMAN OTC DRUG XtraCare Instant Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333E Rejoice International ALCOHOL 37 g/60g 57337-060_a2824ba7-1e51-4b7a-b38e-ed228eed7110 57337-060 HUMAN OTC DRUG XtraCare Creamy Petroleum Jelly Petrolatum JELLY TOPICAL 20140218 OTC MONOGRAPH FINAL part347 Rejoice International PETROLATUM 38 g/127g 57337-061_794765b6-47f3-48e4-ae9d-15ab5963a2da 57337-061 HUMAN OTC DRUG XtraCare Creamy Petroleum Jelly Petrolatum JELLY TOPICAL 20140218 OTC MONOGRAPH FINAL part347 Rejoice International PETROLATUM 38 g/127g 57337-062_9c6cabdc-86c3-4e47-bf37-670e5c8ce67d 57337-062 HUMAN OTC DRUG XtraCare Wet Wipes Benzethonium Chloride SWAB TOPICAL 20140313 OTC MONOGRAPH NOT FINAL part333E Rejoice International BENZETHONIUM CHLORIDE 3 mg/100mg 57337-064_b2a3809d-ae5f-4d2b-bcb1-093e909c8768 57337-064 HUMAN OTC DRUG XtraCare 2 in 1 Hair Cleanse and Condition Coconut Water Pyrithione Zinc SHAMPOO TOPICAL 20140827 OTC MONOGRAPH FINAL part358H Rejoice International Inc. PYRITHIONE ZINC 2 g/100g 57337-065_850df0ef-803b-4c2c-a095-31f69d8e59e9 57337-065 HUMAN OTC DRUG XtraCare 2 in 1 Hair Cleanse and Condition Green Apple Pyrithione Zinc SHAMPOO TOPICAL 20140827 OTC MONOGRAPH FINAL part358H Rejoice International Inc. PYRITHIONE ZINC 2 g/100g 57337-066_db0e2318-ddc2-4d1c-a269-ed3c5d5ca9f1 57337-066 HUMAN OTC DRUG Wet Wipes benzethonium chloride CLOTH TOPICAL 20141208 OTC MONOGRAPH NOT FINAL part333E Rejoice International BENZETHONIUM CHLORIDE .3 g/1 57337-067_0d5aa642-d431-4cf4-b3d4-c967283f6c7b 57337-067 HUMAN OTC DRUG Wet Wipes benzethonium chloride CLOTH TOPICAL 20141208 OTC MONOGRAPH NOT FINAL part333E Rejoice International BENZETHONIUM CHLORIDE .3 g/1 57337-068_f9cfa019-3cb1-4683-afc3-3be94afe2c90 57337-068 HUMAN OTC DRUG Wet Wipes benzethonium chloride CLOTH TOPICAL 20141208 OTC MONOGRAPH NOT FINAL part333E Rejoice International BENZETHONIUM CHLORIDE .3 g/1 57344-001_00347e67-180f-4c09-9fd7-98267ef3ec1d 57344-001 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ACETAMINOPHEN 325 mg/1 57344-003_ea5b34f0-4ad2-404f-a2ec-88c7bc17fbf8 57344-003 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ACETAMINOPHEN 500 mg/1 57344-004_f5c97070-c7eb-43d7-888e-9864af4fcfb5 57344-004 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, COATED ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ACETAMINOPHEN 500 mg/1 57344-018_aefa6f29-c36c-4db6-bfb7-a2df5ab3a47a 57344-018 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, COATED ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ASPIRIN 325 mg/1 57344-019_b70eecaa-44d5-4b55-9247-c6f33b6b5e74 57344-019 HUMAN OTC DRUG Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20121215 OTC MONOGRAPH FINAL part338 AAA Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 57344-020_ebb60cf2-3eee-49ec-b08a-220e43f1f486 57344-020 HUMAN OTC DRUG Caffeine CAFFEINE TABLET ORAL 20121215 OTC MONOGRAPH FINAL part340 AAA Pharmaceutical, Inc. CAFFEINE 200 mg/1 57344-028_fb728dad-2054-4f60-85a9-4b49ecf081ef 57344-028 HUMAN OTC DRUG Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20121215 OTC MONOGRAPH FINAL part338 AAA Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 57344-035_0f500946-18c8-4139-8f09-3bf58fd85c95 57344-035 HUMAN OTC DRUG Pseudoephedrine Hydrochloride PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 57344-080_10c8873c-bcbd-4fe5-8358-775eb9abdb8b 57344-080 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, DELAYED RELEASE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ASPIRIN 81 mg/1 57344-081_a6f227fc-1807-4d88-a7b0-a0fa4e9d9f5d 57344-081 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, DELAYED RELEASE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ASPIRIN 325 mg/1 57344-090_d9529bb8-12e2-4115-8d08-35076244fa64 57344-090 HUMAN OTC DRUG Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 57344-091_68084330-aaed-4ea9-a002-0a34b7312e5e 57344-091 HUMAN OTC DRUG Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20121215 OTC MONOGRAPH FINAL part338 AAA Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 57344-092_c139cf5d-3428-4271-ada1-f20b434dcbcb 57344-092 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, COATED ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ACETAMINOPHEN 500 mg/1 57344-095_052c52a3-1bc5-499c-8cc8-b28c1547bd7d 57344-095 HUMAN OTC DRUG Acetaminophen PM Acetaminophen and DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20121213 OTC MONOGRAPH FINAL part338 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 57344-098_158799bd-d45c-4779-b2d2-2b68ffaba23d 57344-098 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, COATED ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ACETAMINOPHEN 500 mg/1 57344-101_8318049c-8927-4544-b050-499fb34d8956 57344-101 HUMAN OTC DRUG Acetaminophen, Diphenhydramine Hydrochloride ACETAMINOPHEN and DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 12.5 mg/1; mg/1 57344-105_fc3ea080-77cb-4da8-a916-afc70bfc738f 57344-105 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, CHEWABLE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ASPIRIN 81 mg/1 57344-109_60e8efbe-7e39-4698-9bdf-50b6487bf523 57344-109 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20121204 ANDA ANDA079129 AAA Pharmaceutical, Inc. IBUPROFEN 200 mg/1 57344-110_55f21d7c-3c42-4044-965a-aaadefcc4ba1 57344-110 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20121204 ANDA ANDA079129 AAA Pharmaceutical, Inc. IBUPROFEN 200 mg/1 57344-111_a13e3b28-9a54-462e-bbe4-c7a6452c5b5b 57344-111 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20121204 ANDA ANDA091355 AAA Pharmaceutical, Inc. IBUPROFEN 200 mg/1 57344-112_19d120e6-ff7a-4e2e-bd25-e8c89c99beb7 57344-112 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20121204 ANDA ANDA091355 AAA Pharmaceutical, Inc. IBUPROFEN 200 mg/1 57344-113_82d0cc68-3a24-4f86-bdb8-00f3cf364375 57344-113 HUMAN OTC DRUG Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 57344-119_8cefa83b-202c-41d0-9965-ed615ffce5eb 57344-119 HUMAN OTC DRUG Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 57344-120_e3f2dfa7-3762-40ba-9ecd-7e6aeb3c1562 57344-120 HUMAN OTC DRUG Acetaminophen, Phenylephrine Hydrochloride ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 57344-123_d7402b15-fa6c-4197-98e2-b4ecad1b64c4 57344-123 HUMAN OTC DRUG Acetaminophen, Phenylephrine Hydrochloride ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 57344-124_61c8f3f8-37b8-46c2-a90a-d97f2b057ca6 57344-124 HUMAN OTC DRUG Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 57344-125_69471d5f-7f6e-4fd9-ae53-f4ce2866d101 57344-125 HUMAN OTC DRUG Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 57344-126_2ca2f908-51b2-47d9-a0b7-4da58ac6ab33 57344-126 HUMAN OTC DRUG Acetaminophen, Diphenhydramine Hyhrochloride, Phenylephrine Hydrochloride ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 57344-127_638ae864-5a49-46b4-9a41-aa926e2a0305 57344-127 HUMAN OTC DRUG Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 57344-128_d28e5412-c97c-4ed8-bb1c-47f44e8f0547 57344-128 HUMAN OTC DRUG Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 57344-131_6e19e526-1f1c-41ba-90ff-bbaff1e3ecf8 57344-131 HUMAN OTC DRUG Phenylephrine Hydrochloride PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 57344-133_3b1386d4-3060-44dd-94f2-7e95a7d126ed 57344-133 HUMAN OTC DRUG Chlorpheniramine Maleate, Phenylephrine Hydrochloride CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 57344-134_ad636072-c579-423d-a291-6574e43f1187 57344-134 HUMAN OTC DRUG Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 57344-136_8ffe8753-299d-46e2-a967-d7d1512bba2a 57344-136 HUMAN OTC DRUG Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 57344-138_e63493e7-61f1-4e10-86c3-25e26e18b807 57344-138 HUMAN OTC DRUG Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 57344-139_91cd3662-4fd2-479f-ad1d-618b81f6f839 57344-139 HUMAN OTC DRUG Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 57344-144_e4a322f3-1cce-4c34-ac8a-21b218a879ff 57344-144 HUMAN OTC DRUG Naproxen Sodium NAPROXEN SODIUM TABLET, COATED ORAL 20121215 ANDA ANDA079096 AAA Pharmaceutical, Inc. NAPROXEN SODIUM 220 mg/1 57344-145_5d765fcc-bfa7-4791-b533-b28f73b01f40 57344-145 HUMAN OTC DRUG Naproxen Sodium NAPROXEN SODIUM TABLET, COATED ORAL 20121215 ANDA ANDA079096 AAA Pharmaceutical, Inc. NAPROXEN SODIUM 220 mg/1 57344-146_c18169d7-dbd3-4c01-8296-e060259c32e6 57344-146 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, DELAYED RELEASE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ASPIRIN 81 mg/1 57344-147_d10f835d-c53b-4083-960a-fdaddb965db0 57344-147 HUMAN OTC DRUG Day and Night Cold Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride KIT 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. 57344-149_f0b42e7b-eab2-4048-b894-706ba48f4330 57344-149 HUMAN OTC DRUG Sinus Congestion and Pain Daytime Nighttime Acetaminophen, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride KIT 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. 57344-150_fff544f0-d591-4846-b1a4-e8bb980802a6 57344-150 HUMAN OTC DRUG Cold Multi-Symptom Daytime Nighttime Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride KIT 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. 57344-152_ba405a82-f20f-4160-9b79-b4bf16d13f91 57344-152 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, CHEWABLE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ASPIRIN 81 mg/1 57344-154_8574bbc6-eb08-45d1-b37c-66bc8bd2dd9e 57344-154 HUMAN OTC DRUG Acetaminophen, Phenylephrine Hydrochloride ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 57344-155_37b30e79-02e8-41ec-a0b2-c1d4a9173e1b 57344-155 HUMAN OTC DRUG Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 57344-156_faca8b2e-d481-4bbd-b464-85cc773bc298 57344-156 HUMAN OTC DRUG Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 57344-157_1f1f3f18-e27e-4d3e-95e1-0aca99bda81d 57344-157 HUMAN OTC DRUG Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 57344-158_462fdf0c-9490-4fdf-9c9c-c31ecf0d4a5e 57344-158 HUMAN OTC DRUG Chlorpheniramine Maleate, Phenylephrine Hydrochloride CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 57344-159_315efefa-c8e5-47c5-9594-cc749c155a8f 57344-159 HUMAN OTC DRUG Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 57344-160_1b6854b7-927b-452b-8eab-66d660db5ba3 57344-160 HUMAN OTC DRUG Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 57344-161_235bb3fd-b4e3-44c6-82b5-230ca26e610b 57344-161 HUMAN OTC DRUG Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 57344-162_b79b6936-d18b-4604-a155-6a16eb23dd61 57344-162 HUMAN OTC DRUG Cold Head Congestion Daytime / Nighttime Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride KIT 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. 57344-163_2e4cad0f-e170-45ef-bb17-684eb1e2cbcd 57344-163 HUMAN OTC DRUG Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 57344-170_f1ba6a9d-ddb6-441e-b44e-9c55a029cddd 57344-170 HUMAN OTC DRUG Acetaminophen Rapid Release Acetaminophen TABLET, COATED ORAL 20140326 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ACETAMINOPHEN 500 mg/1 57344-171_46830d77-d9fb-4082-946b-9f0392eadae5 57344-171 HUMAN OTC DRUG Acetaminophen PM Rapid Release Acetaminophen and DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20140326 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 57349-313_ccbec830-bec5-4669-b57a-eb635c347c2c 57349-313 HUMAN OTC DRUG EyS Eye Wash Water SOLUTION OPHTHALMIC 20130301 OTC MONOGRAPH FINAL part349 Eyes-Plus LLC WATER 14.85 mL/15mL 57349-913_97f7de9f-54e8-4be4-8684-5a95cb5d871f 57349-913 HUMAN OTC DRUG EyS Eye Wash Water SOLUTION OPHTHALMIC 20130301 OTC MONOGRAPH FINAL part349 Eyes-Plus LLC WATER .98 mL/mL 57353-101_a251df15-a78e-46ff-a696-1c1198975c20 57353-101 HUMAN OTC DRUG POWER WHITE 7 SENSITIVE SODIUM FLUORIDE POTASSIUM NITRATE GEL, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 DENTOVATIONS INC POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 57353-102_a01d90ee-9f5c-4237-88b7-15a547aa234f 57353-102 HUMAN OTC DRUG POWER WHITE 7 EVERYDAY WHITENING SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 DENTOVATIONS INC SODIUM FLUORIDE .24 g/100g 57353-103_7d87e255-153e-46b3-9d7f-87bb0c8187c2 57353-103 HUMAN OTC DRUG LUSTER NOW INSTANT WHITENING SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 DENTOVATIONS INC SODIUM FLUORIDE .24 g/100g 57353-104_1a416573-b560-4cef-8b02-4a37c369120e 57353-104 HUMAN OTC DRUG POWER WHITE DEEP STAIN ERASER SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 DENTOVATIONS INC SODIUM MONOFLUOROPHOSPHATE .88 g/100g 57356-207_f8c07676-35ec-4e55-bbad-e892ad979e65 57356-207 HUMAN OTC DRUG RX200 Foaming Instant Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20091214 OTC MONOGRAPH NOT FINAL part333A The Bullen Companies, Inc. BENZALKONIUM CHLORIDE 4.918 g/100mL 57366-0001_4a6372b0-c625-4a7f-a7c7-16752bba9a4e 57366-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19951220 UNAPPROVED MEDICAL GAS MedQuest, Inc. OXYGEN 99 L/100L 57367-001_4551f41d-c0e3-485e-950b-9014633e75e7 57367-001 HUMAN OTC DRUG GIGI ANESTHETIC NUMBING LIDOCAINE AEROSOL TOPICAL 19971027 OTC MONOGRAPH FINAL part348 220 LABORATORIES INC LIDOCAINE 40 mg/g 57367-007_f82e9fcf-7441-4beb-8f64-79b6b8ee5061 57367-007 HUMAN OTC DRUG NICK RELIEF ALUMINUM SULFATE STICK TOPICAL 19971127 OTC MONOGRAPH FINAL part347 220 LABORATORIES INC ALUMINUM SULFATE 46 mg/mL 57367-008_2f75fe11-48b7-4221-a4ee-5195ca7832d8 57367-008 HUMAN OTC DRUG Anti-Perspirant Deodorant ALUMINUM CATION STICK TOPICAL 20100525 OTC MONOGRAPH FINAL part350 220 Laboratories Inc ALUMINUM CHLOROHYDRATE 52 mg/g 57367-027_de535765-6fa3-4715-9dcc-037f6dc80577 57367-027 HUMAN OTC DRUG DAY HYDRATOR SPF-15 OCTINOXATE and OCTISALATE and OXYBENZONE LOTION TOPICAL 20060201 OTC MONOGRAPH NOT FINAL part352 220 Laboratories Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 30 mg/g; mg/g; mg/g 57367-029_b0602558-795b-4916-b143-74d0e6e6a84c 57367-029 HUMAN OTC DRUG SUNSCREEN WATER RESISTANT HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE AEROSOL, SPRAY TOPICAL 20100510 OTC MONOGRAPH NOT FINAL part352 220 Laboratories Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 20; 50 mg/g; mg/g; mg/g; mg/g; mg/g 57367-033_3cc1078d-c61a-4b3c-877f-e0cbb6e7b9e7 57367-033 HUMAN OTC DRUG THERABREATH TOOTHPASTE SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20100303 OTC MONOGRAPH FINAL part355 220 LABORATORIES INC SODIUM FLUORIDE 24 mg/10g 57373-100_567df2a8-40e2-40b1-a1ac-3581393506db 57373-100 HUMAN OTC DRUG Natural herb cough drop MENTHOL LOZENGE ORAL 20130220 OTC MONOGRAPH FINAL part341 P.S.W. INC. MENTHOL 3 mg/1 57373-101_3e772b00-0246-4692-89ce-97519525c2a9 57373-101 HUMAN OTC DRUG Natural herb cough drop MENTHOL LOZENGE ORAL 20130318 OTC MONOGRAPH FINAL part341 P.S.W. INC. MENTHOL 3 mg/1 57373-102_6d18c076-9535-4bca-b34c-f6cd252503e1 57373-102 HUMAN OTC DRUG Natural herb cough drop MENTHOL LOZENGE ORAL 20130318 OTC MONOGRAPH FINAL part341 P.S.W. INC. MENTHOL 3 1/1 57373-103_1de15a2d-7cd2-44ab-b937-eb1486e463d1 57373-103 HUMAN OTC DRUG Natural herb cough drop MENTHOL LOZENGE ORAL 20130325 OTC MONOGRAPH FINAL part341 P.S.W. INC. MENTHOL 3 mg/1 57373-105_c9ae1891-6017-4f81-ae07-d76a5802fe85 57373-105 HUMAN OTC DRUG Natural herb cough drop MENTHOL LOZENGE ORAL 20130402 OTC MONOGRAPH FINAL part341 P.S.W. INC. MENTHOL 3 mg/1 57373-108_6cb7a46a-84aa-43fb-8da2-c33ddf573f0b 57373-108 HUMAN OTC DRUG Monkey Holding Peach Brand External Analgesic Balm Camphor,Menthol,Methyl Salicylate OINTMENT TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part348 P.S.W. INC. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 22; 16; 3 g/100g; g/100g; g/100g 57424-141_3e218672-c476-486d-8dfa-fe60d4a2746e 57424-141 HUMAN OTC DRUG Hi-Tech Chloroxylenol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Economical Janitorial Supplies CHLOROXYLENOL 3.75 mg/mL 57451-5025_68e9e829-2bbf-48d5-af68-625518829ea7 57451-5025 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20110606 ANDA ANDA090637 Ipca Laboratories Limited ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 57451-5026_68e9e829-2bbf-48d5-af68-625518829ea7 57451-5026 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20110606 ANDA ANDA090637 Ipca Laboratories Limited ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 57451-5065_65566771-7db3-4f49-ad00-8b561eade5e4 57451-5065 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20100625 ANDA ANDA090283 Ipca Laboratories Limited FAMOTIDINE 10 mg/1 57451-5066_65566771-7db3-4f49-ad00-8b561eade5e4 57451-5066 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20100723 ANDA ANDA090283 Ipca Laboratories Limited FAMOTIDINE 20 mg/1 57451-5067_6f2ce1a0-e50d-4feb-9b52-e70fca156c7e 57451-5067 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Ipca Laboratories Limited CETIRIZINE HYDROCHLORIDE 10 mg/1 57465-100_eb21b7c5-86d1-4046-a5fe-3f06ae050221 57465-100 HUMAN OTC DRUG Estomarol ALUMINUM HYDROXIDE, BISMUTH SUBCARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, SODIUM BICARBONATE POWDER ORAL 20110511 OTC MONOGRAPH FINAL part331 Laboratorios Imperiales, S.A. de C.V. ALUMINUM HYDROXIDE; BISMUTH SUBCARBONATE; CALCIUM CARBONATE; MAGNESIUM CARBONATE; SODIUM BICARBONATE .18; .21; .25; .59; 2.27 g/3.5g; g/3.5g; g/3.5g; g/3.5g; g/3.5g 57469-001_4b1cc6ad-36a2-447f-8888-5372cb8a2c75 57469-001 HUMAN OTC DRUG Disney Minnie Antibacterial Hand Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130313 OTC MONOGRAPH FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-002_5ce688d2-8b4e-41da-a52a-b4a655e022d9 57469-002 HUMAN OTC DRUG Disney Princess Antibacterial Hand Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-003_2c1ec938-72a1-44c9-9ce5-00651c2ec8f2 57469-003 HUMAN OTC DRUG Disney PIXAR Toy Story Antibacterial Hand Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130313 OTC MONOGRAPH FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-004_24783d63-b962-4a93-abfd-363611f4d440 57469-004 HUMAN OTC DRUG Disney PIXAR Cars Antibacterial Hand Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130313 OTC MONOGRAPH FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-005_4d24a53a-cfe4-4630-a850-4c32d692e0e1 57469-005 HUMAN OTC DRUG Disney PIXAR Monsters University Antibacterial Hand Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130313 OTC MONOGRAPH FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-011_156c0d3b-aca8-4664-9cf7-c9529fb2d44f 57469-011 HUMAN OTC DRUG Disney Minnie Antiseptic Hand Cleansing Cotton Candy Scented ALCOHOL GEL TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. ALCOHOL 620 mg/mL 57469-012_dafaf4fa-cb6d-4592-bb74-8c54250265ec 57469-012 HUMAN OTC DRUG Disney Princess Antiseptic Hand Cleansing Raspberry Scented ALCOHOL GEL TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. ALCOHOL 620 mg/mL 57469-013_20aac1d8-3fb2-4e16-9d2b-32d5381ae0e2 57469-013 HUMAN OTC DRUG Disney PIXAR Toy Story Antiseptic Hand Cleansing Berry Scented ALCOHOL GEL TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. ALCOHOL 620 mg/mL 57469-014_a8e02a4d-8744-43c0-aa01-8c99cb9c4969 57469-014 HUMAN OTC DRUG Disney PIXAR Cars Antiseptic Hand Cleansing Cherry Scented ALCOHOL GEL TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. ALCOHOL 620 mg/mL 57469-015_bc021b6c-39cb-492b-97a5-8d486c2c0c1d 57469-015 HUMAN OTC DRUG Disney Monsters University Antiseptic Hand Cleansing Grape Scented ALCOHOL GEL TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. ALCOHOL 620 mg/mL 57469-020_deece25d-7025-47f0-8773-dab99184a509 57469-020 HUMAN OTC DRUG Disney PIXAR Cars Antibacterial Hand Wipes BENZALKONIUM CHLORIDE PATCH TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-021_cca21ffa-6be3-4894-8629-3b5025319c7f 57469-021 HUMAN OTC DRUG Disney MINNIE Antibacterial Hand Wipes BENZALKONIUM CHLORIDE PATCH TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-022_26414859-8393-47ac-a2a9-e5bf617095a6 57469-022 HUMAN OTC DRUG Disney PIXAR MONSTERS UNIVERSITY Antibacterial Hand Wipes BENZALKONIUM CHLORIDE PATCH TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-023_0b179158-3e21-4050-92c7-0b28676a7fae 57469-023 HUMAN OTC DRUG Disney PRINCESS Antibacterial Hand Wipes BENZALKONIUM CHLORIDE PATCH TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-024_0d6e1bff-3427-45a7-9ef6-ce5d8ce20d44 57469-024 HUMAN OTC DRUG Disney PIXAR TOY STORY Antibacterial Hand Wipes BENZALKONIUM CHLORIDE PATCH TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-025_a683622f-8c7f-446f-8e14-42f7094657b9 57469-025 HUMAN OTC DRUG Disney Antibacterial Hand Wipes - PRINCESS, CARS, MINNIE BENZALKONIUM CHLORIDE KIT 20130803 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. 57469-026_a9a7f1da-3b43-42fe-86fc-2b98b781f2ad 57469-026 HUMAN OTC DRUG Disney Antibacterial Hand Wipes - TOY STORY, CARS, MONSTERS UNIVERSITY BENZALKONIUM CHLORIDE KIT 20130803 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. 57469-027_3cb383aa-cc1a-49d1-9841-6f9e3dec9240 57469-027 HUMAN OTC DRUG Disney Fairies Antibacterial Hand Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-030_28f0cccf-cc67-4230-8977-770e6f7a287a 57469-030 HUMAN OTC DRUG MARVEL ULTIMATE SPIDER-MAN ANTISEPTIC HAND CLEANSING BERRY SCENTED ALCOHOL GEL TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. ALCOHOL 62 mL/100mL 57469-040_f75debe9-2bd0-4789-a710-a3ec3b9af2d9 57469-040 HUMAN OTC DRUG MARVEL ULTIMATE SPIDER-MAN ANTIBACTERIAL HAND WIPES BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-050_72d5fabc-194d-491e-b2a5-1ee90a6aa3e2 57469-050 HUMAN OTC DRUG Disney PRINCESS Raspberry Scented Antiseptic Hand CLEANSING ALCOHOL GEL TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. ALCOHOL 62 mL/100mL 57469-051_ffff2868-a046-4c5f-a3de-b6714f5efaa0 57469-051 HUMAN OTC DRUG Disney MINNIE Cotton Candy Scented Antiseptic Hand CLEANSING ALCOHOL GEL TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. ALCOHOL 62 mL/100mL 57469-052_d3b1e6d0-48c5-43b8-bc8d-3b2bf6bb6b67 57469-052 HUMAN OTC DRUG Disney FAIRIES Sweet Berry Scented Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. ALCOHOL 62 mL/100mL 57469-053_6491e509-a502-43fa-a800-4f2babc5dd29 57469-053 HUMAN OTC DRUG Disney FROZEN BERRY SCENTED ANTISEPTIC HAND CLEANSING ALCOHOL GEL TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. ALCOHOL 62 mL/100mL 57469-054_b07d5f3f-d168-4cb6-bd4d-2220faeb2017 57469-054 HUMAN OTC DRUG MARVEL ULTIMATE SPIDER-MAN BERRY SCENTED ANTISEPTIC HAND CLEANSING ALCOHOL GEL TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. ALCOHOL 62 mL/100mL 57469-055_df371d21-596a-47c0-9f94-a4eee5b516fe 57469-055 HUMAN OTC DRUG Disney PLANES FIRE and RESCUE BERRY SCENTED Antiseptic Hand CLEANSING ALCOHOL GEL TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. ALCOHOL 62 mL/100mL 57469-056_7cfbd550-7033-4162-a2ca-0d96c56688c1 57469-056 HUMAN OTC DRUG Disney PIXAR Cars BERRY SCENTED Antiseptic Hand CLEANSING ALCOHOL GEL TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. ALCOHOL 62 mL/100mL 57469-057_a35b0f97-214f-45f9-bb8f-b8db8e6ae2d9 57469-057 HUMAN OTC DRUG Disney PRINCESS Antibacterial Hand Wipes BENZALKONIUM CHLORIDE PATCH TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-058_9808c0ce-a5e6-4b2b-a189-916b78cb23bf 57469-058 HUMAN OTC DRUG Disney MINNIE Antibacterial HAND WIPES BENZALKONIUM CHLORIDE PATCH TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-059_9a56727b-7ce4-4529-b79b-5b1f84c011e2 57469-059 HUMAN OTC DRUG Disney FAIRIES Antibacterial Hand Wipes BENZALKONIUM CHLORIDE PATCH TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-060_31419186-bdbc-4301-845e-622d1339d6c8 57469-060 HUMAN OTC DRUG Disney FROZEN ANTIBACTERIAL HAND WIPES BENZALKONIUM CHLORIDE PATCH TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-061_42bcafd5-a257-453f-ae6a-de3a1ef85d30 57469-061 HUMAN OTC DRUG MARVEL ULTIMATE SPIDER-MAN ANTIBACTERIAL HAND WIPES BENZALKONIUM CHLORIDE PATCH TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-062_05c438b6-4c7e-41e9-8407-5f27b9a013f2 57469-062 HUMAN OTC DRUG Disney PLANES FIRE and RESCUE ANTIBACTERIAL HAND WIPES BENZALKONIUM CHLORIDE PATCH TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57469-063_aa8c283d-243b-4ce9-a7e5-e8ef6058602b 57469-063 HUMAN OTC DRUG Disney PIXAR Cars Antibacterial Hand Wipes BENZALKONIUM CHLORIDE PATCH TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g 57471-3061_5d48ea4c-f49e-4ce3-b126-589bece4170a 57471-3061 HUMAN OTC DRUG Bryonia Alba Bryonia Alba PELLET ORAL 19880701 UNAPPROVED HOMEOPATHIC Celletech Ltd. BRYONIA ALBA ROOT 30 [hp_C]/1 57472-001_2f95294f-4a96-48c1-b62a-3abf4e6be739 57472-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS AIRGAS NOR PAC INC OXYGEN 995 mL/L 57472-002_5bf03867-b1da-4bce-95fa-c63c871a255c 57472-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS AIRGAS NOR PAC INC NITROGEN 995 mL/L 57472-003_7881d7c9-ebea-4092-8b21-38d2b823ad17 57472-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS AIRGAS NOR PAC INC NITROUS OXIDE 992 mL/L 57472-004_6fdd4b14-a689-45c7-9c68-848483abc227 57472-004 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS AIRGAS NOR PAC INC CARBON DIOXIDE 992 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 57472-005_8852cad5-9e11-4bf0-8986-037792f57539 57472-005 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mix Carbon Dioxide Oxygen Mix GAS RESPIRATORY (INHALATION) 19820101 UNAPPROVED MEDICAL GAS AIRGAS-NORPAC INC. CARBON DIOXIDE; OXYGEN 200; 800 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 57472-006_903f6c44-2f78-42ad-a79f-230bb3b578b6 57472-006 HUMAN PRESCRIPTION DRUG AIR AIR GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS AIRGAS-NORPAC INC. AIR 1000 mL/L 57472-007_7a83fc9c-ae0c-430a-bdf6-443d1370df88 57472-007 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS AIRGAS-NORPAC INC. HELIUM 995 mL/L 57479-101_65756674-3eae-45a7-bc61-d0694015aeb3 57479-101 HUMAN OTC DRUG POISON OAK HYDROCORTISONE, PHENOL GEL TOPICAL 20121129 OTC MONOGRAPH NOT FINAL part348 DeMartini Spring Hill Pharmacy, Inc. HYDROCORTISONE; PHENOL 1; .5 g/100g; g/100g 57483-001_49517d2c-a3f5-4d18-bccf-9582cd656559 57483-001 HUMAN OTC DRUG Apeaz Ultra camphor, menthol, methyl salicylate cream CREAM TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part348 Innovus Pharmaceuticals, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g 57483-003_8ed5ea44-59d6-4851-8fa6-e8babc69206a 57483-003 HUMAN OTC DRUG EJECTDELAY Gel Benzocaine 7.5% GEL TOPICAL 20130715 OTC MONOGRAPH FINAL part333B Innovus Pharmaceuticals, Inc. BENZOCAINE 7.5 g/100g 57483-003_d4d19065-51a3-4c21-a615-060a82546328 57483-003 HUMAN OTC DRUG EJECTDELAY Gel Benzocaine 7.5% GEL TOPICAL 20130715 OTC MONOGRAPH FINAL part333B Innovus Pharmaceuticals, Inc. BENZOCAINE 7.5 g/100g 57501-865_10d2838b-1bb2-47ef-a726-1ae087ce63c8 57501-865 HUMAN OTC DRUG Mata Piojos A Pediculicide Low Foaming Pyrethrum Extract, Piperonyl Butoxide SHAMPOO TOPICAL 20100423 OTC MONOGRAPH FINAL part358G Apex International Mfg PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 2.4; .12 g/60g; g/60g 57501-953_5533c604-c92e-4002-87ce-c163df9a4cb1 57501-953 HUMAN OTC DRUG Oil Free Acne Scrub Salicylic Acid Acne Treatment Salicylic Acid LIQUID TOPICAL 20100708 OTC MONOGRAPH FINAL part333D Apex International Mfg SALICYLIC ACID 2.5 g/125g 57520-0001_18a805a3-dab5-4a5d-a070-2488ad11cdf4 57520-0001 HUMAN OTC DRUG Additox Phytolacca decandra, Trifolium pratense, Xanthoxylum fraxineum, Arsenicum album, LIQUID ORAL 20100128 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ASPARTAME; ATROPA BELLADONNA; BENZALKONIUM CHLORIDE; CHELIDONIUM MAJUS; FORMALDEHYDE; LYCOPODIUM CLAVATUM SPORE; METHYLENE CHLORIDE; METHYLPARABEN; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PROPYLPARABEN; RED CLOVER; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZANTHOXYLUM AMERICANUM BARK; ZINC OXIDE 12; 30; 12; 30; 12; 30; 12; 30; 30; 12; 3; 30; 3; 30; 30; 30; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0002_7b47c776-97e6-4474-94b1-72f2028930f3 57520-0002 HUMAN OTC DRUG ASTH HP Arsenicum album, Belladonna, Ipecacuanha, Kali carbonicum LIQUID ORAL 20100201 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ATROPA BELLADONNA; IPECAC; LOBELIA INFLATA; POTASSIUM CARBONATE; SILICON DIOXIDE; SODIUM SULFATE 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0003_e0aaa45b-915e-4a7f-ac0b-599efdce054a 57520-0003 HUMAN OTC DRUG Bio Wild Oat Wild oat, LIQUID ORAL 20100204 UNAPPROVED HOMEOPATHIC Apotheca Company BROMUS RAMOSUS FLOWER 200 [hp_C]/mL 57520-0004_48a57590-5e88-44eb-bd9f-44bbbeeaa027 57520-0004 HUMAN OTC DRUG ASP Echinacea angustifolia, Hydrastis canadensis, Tabebuia impetiginosa, Glandula suprarenalis, Thymus, Thyroidinum, Arsenicum album, Bryonia alba, Cocculus indicus, Colchicum autumnale, LIQUID ORAL 20100202 UNAPPROVED HOMEOPATHIC Apotheca Company ANAMIRTA COCCULUS SEED; ARSENIC TRIOXIDE; ASPERGILLUS FLAVUS; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LEDUM PALUSTRE TWIG; MERCURIC CYANIDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; TABEBUIA IMPETIGINOSA BARK; THYMUS; THYROID 12; 12; 200; 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 8; 3; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0005_f51c856b-3152-426d-9f97-f673793b99e5 57520-0005 HUMAN OTC DRUG Bio White Chestnut White chestnut, LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company AESCULUS HIPPOCASTANUM FLOWER 200 [hp_C]/mL 57520-0006_171d2314-3d6a-4bbb-9eff-2d073d511980 57520-0006 HUMAN OTC DRUG Bio Impatiens Impatiens, LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company IMPATIENS GLANDULIFERA FLOWER 200 [hp_C]/mL 57520-0007_2b080b4f-8594-4865-a35d-86e212ca70f7 57520-0007 HUMAN OTC DRUG Bio Iodine Colloidal iodine, LIQUID ORAL 20100204 UNAPPROVED HOMEOPATHIC Apotheca Company IODINE 6 [hp_X]/mL 57520-0008_60ad8f78-ebae-4cb1-9c28-acb3d9fc0bbe 57520-0008 HUMAN OTC DRUG Bio Water Violet Water violet, LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company HOTTONIA PALUSTRIS FLOWER 200 [hp_C]/mL 57520-0009_2cada499-0223-4a5d-ad74-8308f4bc141a 57520-0009 HUMAN OTC DRUG Bio Clematis Clematis LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company CLEMATIS VITALBA FLOWER 200 [hp_C]/mL 57520-0010_20d0bbe4-1d91-471b-b24c-dd8e635d6086 57520-0010 HUMAN OTC DRUG Bio Cerato Cerato LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company CERATOSTIGMA WILLMOTTIANUM FLOWER 200 [hp_C]/mL 57520-0011_45827f44-bae0-4266-8d64-53e9a13ba01f 57520-0011 HUMAN OTC DRUG Bio Gorse Gorse LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company ULEX EUROPAEUS 200 [hp_C]/mL 57520-0012_2ab78f0e-28a6-4340-bb10-40431e47e6e5 57520-0012 HUMAN OTC DRUG Bio Electrolyte Boricum gluconicum, Calcarea gluconica, Chromium gluconicum, Cobaltum gluconicum, Cuprum gluconicum, Ferrum gluconicum, Kali gluconicum, LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company BORON GLUCONATE; CALCIUM GLUCONATE; CHROMIUM GLUCONATE; COBALTOUS GLUCONATE; COPPER GLUCONATE; FERROUS GLUCONATE; MAGNESIUM GLUCONATE; MANGANESE GLUCONATE; NICKEL GLUCONATE; POTASSIUM GLUCONATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM DIOXIDE; SODIUM GLUCONATE; TRIBASIC CALCIUM PHOSPHATE; VANADIUM; ZINC GLUCONATE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 6; 6; 9; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0014_dae94ca6-eb8e-4c9e-b62b-6fe048b0750b 57520-0014 HUMAN OTC DRUG Allergen II Kali gluconicum, Adrenalinum, Hepar bovinum, Arsenicum album, Phosphorus, Pulsatilla, Sulphur, Histaminum hydrochloricum, LIQUID ORAL 20100129 UNAPPROVED HOMEOPATHIC Apotheca Company ACER NEGUNDO POLLEN; AGROSTIS GIGANTEA TOP; ALFALFA; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA; AMBROSIA PSILOSTACHYA POLLEN; ARSENIC TRIOXIDE; BEEF LIVER; BETULA OCCIDENTALIS POLLEN; CARYA CORDIFORMIS POLLEN; DACTYLIS GLOMERATA TOP; EPINEPHRINE; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; HISTAMINE DIHYDROCHLORIDE; JUGLANS NIGRA POLLEN; PHLEUM PRATENSE POLLEN; PHOSPHORUS; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; POTASSIUM GLUCONATE; PULSATILLA VULGARIS; QUERCUS RUBRA POLLEN; RED CLOVER; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SOLIDAGO VIRGAUREA POLLEN; SULFUR; ULMUS AMERICANA POLLEN 30; 30; 30; 30; 30; 30; 12; 8; 30; 30; 30; 8; 30; 30; 30; 30; 30; 12; 30; 30; 30; 6; 12; 30; 30; 30; 30; 30; 30; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0015_f9bfc344-5214-4af2-96e3-a09952346307 57520-0015 HUMAN OTC DRUG Adrenal Tonic Aralia quinquefolia, Glycyrrhiza, Sarsaparilla, Avena sativa, Glandula suprarenalis bovinum, Adrenalinum, LIQUID ORAL 20100128 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BOS TAURUS ADRENAL GLAND; EPINEPHRINE; GLYCYRRHIZA GLABRA; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SARSAPARILLA ROOT; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 1; 12; 3; 8; 30; 1; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0017_815f6b6d-1f2e-4e5f-ac96-840bf1989c12 57520-0017 HUMAN OTC DRUG Acne Carbo animalis, Carbo vegetabilis, Kali bichromicum LIQUID ORAL 20100128 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; CARBO ANIMALIS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CHLORIDE; SULFUR; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0018_e84d8665-9aa3-4836-b913-7c5961f32d99 57520-0018 HUMAN OTC DRUG Adrenoplex Chelidonium majus, Echinacea angustifolia LIQUID ORAL 20100128 UNAPPROVED HOMEOPATHIC Apotheca Company BOS TAURUS ADRENAL GLAND; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SILYBUM MARIANUM SEED; SODIUM CHLORIDE; SUS SCROFA SPLEEN 8; 3; 3; 12; 12; 12; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0020_64aa5d52-d164-48b5-9cfb-6ce448cba59f 57520-0020 HUMAN OTC DRUG Bio Aspen Aspen LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company POPULUS TREMULA FLOWERING TOP 200 [hp_C]/mL 57520-0021_cb796b47-2f58-4801-b1a7-9d080a6fd841 57520-0021 HUMAN OTC DRUG BAC HP Apis mellifica, Arsenicum album, Belladonna, Chamomilla, Lachesis mutus, Mercurius solubilis, Pulsatilla, Rhus toxicodendron, Silicea, LIQUID ORAL 20100202 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0022_082fc0bb-037e-48be-b4c1-811449c4209b 57520-0022 HUMAN OTC DRUG Allerpoll HP Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Euphrasia officinalis, Nux vimica, Phosphorus, Pulsatilla, Solidago virgaurea, Sulphur, LIQUID ORAL 20100201 UNAPPROVED HOMEOPATHIC Apotheca Company AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0023_955796ad-d8f6-4203-ad44-3a4e2cad46fb 57520-0023 HUMAN OTC DRUG Androbalance Androstenedione, Dehydroepiandrosterone, Pregenolone, Progesterone, Testosterone SPRAY ORAL 20100201 UNAPPROVED HOMEOPATHIC Apotheca Company ANDROSTENEDIONE; PRASTERONE; PREGNENOLONE; PROGESTERONE; TESTOSTERONE 6; 6; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0024_6feb738c-16fa-49f8-9b00-7377c1bdea4f 57520-0024 HUMAN OTC DRUG Amoebatox Triticum aestivum, Baptisia tinctoria Capsicum anuum, Columbo, Fragaria vesca, Hamamelis virginiana, Hydrastis canadensis, Quassia amara, Senna, Liver, Pancreas, Spleen, Belladonna, Cinchona officinal LIQUID ORAL 20100201 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; CAPSICUM; CINCHONA OFFICINALIS BARK; ENTAMOEBA HISTOLYTICA; FRAGARIA VESCA FRUIT; GIARDIA LAMBLIA; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; JATEORHIZA CALUMBA ROOT; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PORK LIVER; QUASSIA AMARA WOOD; SENNA LEAF; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; TRITICUM AESTIVUM POLLEN 12; 3; 3; 12; 200; 3; 200; 3; 3; 3; 12; 12; 8; 3; 3; 12; 8; 8; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0025_f31eefe9-428e-4ad9-806a-508b136b566f 57520-0025 HUMAN OTC DRUG Allerforce Chondrus crispus, Glycyrrhiza glabra, Sarsaparilla, Zingiber officinale, Adrenalinum, Allium cepa, Aralia racemosa, Arsenicum album, Calcarea carbonica, Cantharis, Iodium, Natrum carbonicum, Rhus toxi LIQUID ORAL 20100201 UNAPPROVED HOMEOPATHIC Apotheca Company ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; CHONDRUS; EPINEPHRINE; GINGER; GLYCYRRHIZA GLABRA; IODINE; LYTTA VESICATORIA; ONION; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SARSAPARILLA; SODIUM CARBONATE; TOXICODENDRON PUBESCENS LEAF 12; 12; 3; 8; 3; 3; 12; 12; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0026_6ed9809a-a0da-4e65-b921-1f61c85949d0 57520-0026 HUMAN OTC DRUG ACNEFORCE Berberis vulgaris, Cimicifuga racemosa, Hydrocotyle asiatica, Lappa major, Belladonna, Calcarea carbonica, Causticum, Eugenia jambosa, LIQUID ORAL 20100128 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTIUM LAPPA ROOT; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CAUSTICUM; CENTELLA ASIATICA; EUGENIA JAMBOS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PALLADIUM; POTASSIUM BROMIDE; SEPIA OFFICINALIS JUICE; VIOLA TRICOLOR 3; 12; 3; 3; 12; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0027_b0ac35e3-8ef1-48af-b4e5-76c696c552e5 57520-0027 HUMAN OTC DRUG Acetaldehyde Acetaldehyde LIQUID ORAL 20100127 UNAPPROVED HOMEOPATHIC Apotheca Company ACETALDEHYDE 30 [hp_C]/mL 57520-0028_e04d4a94-4a91-4f99-9273-cd6a43dfa30a 57520-0028 HUMAN OTC DRUG Adaptagen Aralia quinquefolia, Avena sativa, Capsicum annuum, Ginkgo biloba, Glycyrrhiza glabra, Hydrocotyle asiatica, Thiaminum hydrochloricum, LIQUID ORAL 20100128 UNAPPROVED HOMEOPATHIC Apotheca Company ADENOSINE TRIPHOSPHATE; AMERICAN GINSENG; ASCORBIC ACID; AVENA SATIVA FLOWERING TOP; BOS TAURUS ADRENAL GLAND; CENTELLA ASIATICA; CHILI PEPPER; COPPER GLUCONATE; GINKGO; GLYCYRRHIZA GLABRA; IODINE; LEDUM PALUSTRE TWIG; MOLYBDENUM; PHOSPHORIC ACID; RIBOFLAVIN; SELENIUM; SEPIA OFFICINALIS JUICE; SODIUM CARBONATE; SUS SCROFA SPLEEN; THIAMINE HYDROCHLORIDE; THYROID; TRINITROPHENOL; VANADIUM 30; 3; 6; 3; 8; 3; 3; 12; 3; 3; 12; 12; 12; 12; 6; 12; 12; 12; 8; 4; 8; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0029_ac9fa519-941a-4432-848e-4a3406cb338d 57520-0029 HUMAN OTC DRUG Bio Elm Elm, LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company ULMUS AMERICANA POLLEN 200 [hp_C]/mL 57520-0030_f56a68f1-5b95-4082-b522-fbb3131ddfd6 57520-0030 HUMAN OTC DRUG Bio Olive Olive LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company OLEA EUROPAEA FLOWER 200 [hp_C]/mL 57520-0031_966f2217-ccbc-4251-b93e-6614b4d88d03 57520-0031 HUMAN OTC DRUG Bio Sweet Chestnut Sweet chestnut. LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company CASTANEA SATIVA FLOWER 200 [hp_C]/mL 57520-0032_e56cc7d9-6609-45df-ada6-8a012a10056f 57520-0032 HUMAN OTC DRUG Bio Walnut Walnut LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company JUGLANS REGIA FLOWERING TOP 200 [hp_C]/mL 57520-0033_dfa95519-e07a-4531-afcb-ac73c3160d75 57520-0033 HUMAN OTC DRUG Bronci HP Carbo vegetabilis, Cuprum metallicum, Drosera rotundifolia, Ipecacuanha, Lachesis mutus, Lobelia inflata, Phosphorus, Pulsatilla, Rumex crispus, Spongia tosta, LIQUID ORAL 20100204 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; COPPER; DROSERA ROTUNDIFOLIA; IPECAC; LACHESIS MUTA VENOM; LOBELIA INFLATA; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0034_48d1425a-3f8e-412c-9fd7-436467e1b9fe 57520-0034 HUMAN OTC DRUG Bronchiforce Althaea officinalis, Lobelia inflata, Rheum officinale, Verbascum thapsus, Belladonna, Cuprum aceticum, LIQUID ORAL 20100204 UNAPPROVED HOMEOPATHIC Apotheca Company ALTHAEA OFFICINALIS ROOT; ATROPA BELLADONNA; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPECAC; LOBARIA PULMONARIA; LOBELIA INFLATA; RHEUM OFFICINALE ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; VERBASCUM THAPSUS 3; 12; 12; 12; 12; 12; 3; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0035_a8d5340d-cb24-4114-be5c-bdbca7abf41c 57520-0035 HUMAN OTC DRUG Asthmaforce Arnica montana, Asclepias tuberosa, Eriodictyon californicum, Eucalyptus globulus, Lobelia inflata, Plantago major, LIQUID ORAL 20100201 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; ARNICA MONTANA; ARSENIC TRIOXIDE; ASCLEPIAS TUBEROSA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; ERIODICTYON CALIFORNICUM LEAF; EUCALYPTUS GLOBULUS LEAF; GRINDELIA CAMPORUM TOP; LOBELIA INFLATA; PLANTAGO MAJOR; POTASSIUM CARBONATE; PULSATILLA VULGARIS; RED CLOVER; SODIUM SULFATE 12; 3; 12; 3; 12; 12; 3; 3; 12; 3; 3; 12; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0036_5cf371ad-5633-4d12-9342-5e58f8686d79 57520-0036 HUMAN OTC DRUG BAC Echinacea angustifolia, Hydrastis canadensis, lomatium, Myrrha, Nasturtium aquaticum, Tabebuia impetiginosa, Propolis, LIQUID ORAL 20100202 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ATROPA BELLADONNA; BOTULINUM TOXIN TYPE A; CLOSTRIDIUM PERFRINGENS; ECHINACEA ANGUSTIFOLIA; ESCHERICHIA COLI; GOLDENSEAL; HYPERICUM PERFORATUM; LOMATIUM DISSECTUM ROOT; MYRRH; PHOSPHORUS; PROPOLIS WAX; PROTEUS MIRABILIS; PSEUDOMONAS AERUGINOSA; RORIPPA NASTURTIUM-AQUATICUM; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; TABEBUIA IMPETIGINOSA BARK; THYMUS; THYROID; YERSINIA ENTEROCOLITICA 12; 12; 60; 60; 3; 60; 3; 12; 3; 3; 12; 6; 60; 60; 3; 60; 8; 8; 8; 3; 8; 8; 60 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0037_8f1eb38d-3b59-4f7a-ae45-217021e0bcb3 57520-0037 HUMAN OTC DRUG BAC (GD) Echinacea Angustifolia, Hydrastis canadensis, Lomatium Myrrha, Nasturtium aquaticum, Propolis, LIQUID ORAL 20100202 20150708 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ATROPA BELLADONNA; BOTULINUM TOXIN TYPE A; CLOSTRIDIUM PERFRINGENS; ECHINACEA ANGUSTIFOLIA; ESCHERICHIA COLI; GOLDENSEAL; HYPERICUM PERFORATUM; LOMATIUM DISSECTUM ROOT; MYRRH; PHOSPHORUS; PROPOLIS WAX; PROTEUS MIRABILIS; PSEUDOMONAS AERUGINOSA; RORIPPA NASTURTIUM-AQUATICUM; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; TABEBUIA IMPETIGINOSA BARK; THYMUS; THYROID 12; 12; 60; 60; 3; 60; 3; 12; 3; 3; 12; 6; 60; 60; 3; 60; 8; 8; 8; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [iU]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0038_1189c87f-054d-48cc-adc5-519a48ebfba6 57520-0038 HUMAN OTC DRUG Bio Mustard Mustard LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company BRASSICA RAPA POLLEN 200 [hp_C]/mL 57520-0039_99a22c57-7c98-49c9-be30-6e41e2fa3b24 57520-0039 HUMAN OTC DRUG Bio Myelin Protein Brain, SPRAY ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company PORK BRAIN 12 [hp_X]/mL 57520-0040_c579fca8-76e0-439d-9cd7-9fb7f3ef6a10 57520-0040 HUMAN OTC DRUG Bio Oak Oak, LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company QUERCUS ROBUR FLOWER 200 [hp_C]/mL 57520-0041_cd98c740-0663-4c60-af17-95d7d7d16500 57520-0041 HUMAN OTC DRUG Bio Res Q Star of Bethlehem, Rock rose, Impatiens, Cherry plum, Clematis, LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER 200; 200; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0042_ea97ac6f-eedb-4f07-87d8-7ff7003bbfbe 57520-0042 HUMAN OTC DRUG Bio Willow Willow, LIQUID ORAL 20100204 UNAPPROVED HOMEOPATHIC Apotheca Company SALIX ALBA FLOWERING TOP 200 [hp_C]/mL 57520-0043_45f6abee-22d8-47c8-a3d1-5841cbfcf145 57520-0043 HUMAN OTC DRUG Bone Repair HP Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Fluoricum acidum, Hekla lava, Rhus toxicodendron, Silicea, Symphytum officinale LIQUID ORAL 20100204 UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM FLUORIDE; COMFREY ROOT; HEKLA LAVA; HYDROFLUORIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0044_0c12bc1d-c24b-4812-bdb4-4fc98789d48c 57520-0044 HUMAN OTC DRUG Calciforce Arnica montana, Chamomilla, Echinacea angustifolia, Symphytum officinale, Boron gluconate, LIQUID ORAL 20100205 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BORON GLUCONATE; CALCIUM FLUORIDE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; HEKLA LAVA; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE 3; 6; 12; 3; 3; 12; 12; 3; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0045_b50b0878-8571-4905-bcbb-96fa30144ab0 57520-0045 HUMAN OTC DRUG Venoforce II Hamamelis virginiana. Collinsonia canadensis, Aesculus hippocastanum, Belladonna, Calcarea fluorica, Carduus marianus, LIQUID ORAL 20100820 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; CALCIUM FLUORIDE; CLAVICEPS PURPUREA SCLEROTIUM; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; PULSATILLA VULGARIS; SILYBUM MARIANUM SEED; VIPERA BERUS VENOM 12; 12; 12; 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0046_7b25271f-bb96-4e5e-b37c-0f622753fb39 57520-0046 HUMAN OTC DRUG Candida Alb Candida albicans LIQUID ORAL 20100205 UNAPPROVED HOMEOPATHIC Apotheca Company CANDIDA ALBICANS 200 [hp_X]/mL 57520-0047_631ca6a1-27ff-4f40-9fc5-a79342cb93ce 57520-0047 HUMAN OTC DRUG Candida Combo Candida albicans, LIQUID ORAL 20100205 UNAPPROVED HOMEOPATHIC Apotheca Company CANDIDA ALBICANS 500 [hp_X]/mL 57520-0048_759cd4b0-65e0-483f-8957-7ade99b20ac5 57520-0048 HUMAN OTC DRUG Cardio Tonic Kali muriaticum, Kali phosphoricum, Plantago major, Cactus grandiflorus, Digitalis purpurea, LIQUID ORAL 20100208 UNAPPROVED HOMEOPATHIC Apotheca Company ARTEMISIA ABROTANUM FLOWERING TOP; DIGITALIS; EGG PHOSPHOLIPIDS; IODINE; LEVOCARNITINE; PLANTAGO MAJOR; PORK HEART; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA; THYROID; VALINE 12; 6; 12; 12; 6; 3; 6; 3; 3; 5; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [iU]/mL; [hp_X]/mL; [hp_X]/mL 57520-0049_1c81e730-e359-41cc-83dd-1dacc7736178 57520-0049 HUMAN OTC DRUG Cardioforce II Cardioforce II LIQUID ORAL 20100208 UNAPPROVED HOMEOPATHIC Apotheca Company ARTEMISIA ABROTANUM FLOWERING TOP; BLACK COHOSH; CHELIDONIUM MAJUS; CONVALLARIA MAJALIS; MAGNESIUM SULFATE HEPTAHYDRATE; NERIUM OLEANDER LEAF; PEUMUS BOLDUS LEAF; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; TARAXACUM OFFICINALE 3; 3; 3; 3; 5; 8; 3; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0050_bfd9db01-6e63-4b35-b753-1466fc227406 57520-0050 HUMAN OTC DRUG Cardiotone Adonis vernalis, Strophanthus hispidus, ATP, Cactus grandiflorus, Convallaria majalis, Cor suis, LIQUID ORAL 20100208 UNAPPROVED HOMEOPATHIC Apotheca Company ADENOSINE TRIPHOSPHATE; ADONIS VERNALIS; BIS(CARBOXYETHYL)GERMANIUM SESQUIOXIDE; CONVALLARIA MAJALIS; DIGITALIS; MAGNESIUM; PORK HEART; POTASSIUM GLUCONATE; SELENICEREUS GRANDIFLORUS STEM; STROPHANTHUS HISPIDUS SEED; THYROID; UBIDECARENONE 6; 3; 8; 6; 12; 6; 6; 6; 6; 3; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0051_9c421eb5-f330-4880-9fa5-156f542dcdce 57520-0051 HUMAN OTC DRUG Quiet Calm Quiet Calm LIQUID ORAL 20100127 UNAPPROVED HOMEOPATHIC Apotheca Company AMMONIUM BROMIDE; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA RECUTITA; PHOSPHORIC ACID; TRYPTOPHAN; VALERIAN 3; 6; 1; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0052_92a880e5-ff0f-4618-8a33-e776e3b3e53f 57520-0052 HUMAN OTC DRUG Stomach Relief Stomach Relief LIQUID ORAL 20100127 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; ROBINIA PSEUDOACACIA BARK; STRYCHNOS NUX-VOMICA SEED 30; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 57520-0053_b828dd0e-67a8-4ed3-bb59-1c17a96bbd1d 57520-0053 HUMAN OTC DRUG Nighty Nite Grindelia, Melatonin, Passiflora incarnata, LIQUID ORAL 20100126 UNAPPROVED HOMEOPATHIC Apotheca Company GRINDELIA CAMPORUM TOP; MELATONIN; PASSIFLORA INCARNATA TOP 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0054_45d6a022-6594-46c9-946a-01888893281d 57520-0054 HUMAN OTC DRUG Male Energy Dehydroepiandrosterone, Sabal serrulata, Serotonin, Orichitinum, Pituitarum posterium, LIQUID ORAL 20100127 UNAPPROVED HOMEOPATHIC Apotheca Company CONIUM MACULATUM FLOWERING TOP; PRASTERONE; SAW PALMETTO; SEROTONIN; SUS SCROFA PITUITARY GLAND; SUS SCROFA TESTICLE; TESTOSTERONE; THYROID 12; 6; 6; 30; 8; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 57520-0055_22247ebe-2603-42f2-907a-09bab93e3aaa 57520-0055 HUMAN OTC DRUG Ticked Calendula officinalis, Phytolacca decandra, Borrelia burgdorferi, Adrenalinum, Ledum palustre, Aconitum napellus, Arnica montana, LIQUID ORAL 20100127 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARNICA MONTANA; BORRELIA BURGDORFERI; CALENDULA OFFICINALIS FLOWERING TOP; EPINEPHRINE; LEDUM PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT 30; 30; 200; 3; 8; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0056_01d54a70-307f-4d9d-ab00-fd28bf1ac66c 57520-0056 HUMAN OTC DRUG High Potency Heal Grief Ignatia amara, Natrum muriaticum, Staphysagria LIQUID ORAL 20100126 UNAPPROVED HOMEOPATHIC Apotheca Company DELPHINIUM STAPHISAGRIA SEED; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 200; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0057_68fee4fb-8689-4707-830c-e492e79496a9 57520-0057 HUMAN OTC DRUG Heal Grief Heal Grief LIQUID ORAL 20100126 UNAPPROVED HOMEOPATHIC Apotheca Company DELPHINIUM STAPHISAGRIA SEED; PHOSPHORIC ACID; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 12; 30; 12; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0058_86e495bb-fd3a-4e6f-ae87-1521dbf60215 57520-0058 HUMAN PRESCRIPTION DRUG Energize Energize LIQUID ORAL 20100125 UNAPPROVED HOMEOPATHIC Apothica Company AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; GINGER; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; TRINITROPHENOL 6; 3; 3; 6; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 57520-0059_18cb2cf7-5b2c-49d4-9b0b-649b130719a0 57520-0059 HUMAN OTC DRUG Flexible Rhododendron chrysanthum, Ruta graveolens, Arnica montana, Colchicum autumnale, Phytolacca decandra, Urtica urens, LIQUID ORAL 20100125 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; CAUSTICUM; COLCHICUM AUTUMNALE BULB; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; URTICA URENS; ZINC 6; 12; 6; 30; 12; 6; 6; 6; 12; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0060_d5e1e230-d42b-4b04-8139-4cbd9daa43eb 57520-0060 HUMAN OTC DRUG Happy Heart Cactus grandiflorus, Glonoinum, Kali carbonicum, Spigelia anthelmia, Gelsemium sempervirens, LIQUID ORAL 20100125 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARNICA MONTANA; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; POTASSIUM CARBONATE; RANUNCULUS BULBOSUS; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA; SULFUR 30; 30; 10; 6; 6; 10; 4; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0061_04454b6b-ced7-418e-b80b-4e3b281418c5 57520-0061 HUMAN OTC DRUG Bye, Bye Ver Artemisia vulgaris, Filix mas, Tanacetum vulgare, Teucrium marum, Absinthium, Cina, Chenopodium anthelminticum, LIQUID ORAL 20100205 UNAPPROVED HOMEOPATHIC Apotheca Company ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA CINA FLOWER; ARTEMISIA VULGARIS ROOT; ASCARIS LUMBRICOIDES; CHENOPODIUM AMBROSIOIDES; DRYOPTERIS FILIX-MAS ROOT; ECHINOCOCCUS GRANULOSUS; ENTEROBIUS VERMICULARIS; GRAPHITE; MERCURIC CHLORIDE; SPIGELIA ANTHELMIA; TAENIA SAGINATA; TAENIA SOLIUM; TANACETUM VULGARE TOP; TEUCRIUM MARUM; TURPENTINE 4; 4; 1; 12; 6; 3; 12; 30; 12; 6; 12; 12; 12; 3; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0062_054e5f47-9052-4f59-b35e-9dca6170ce7f 57520-0062 HUMAN OTC DRUG Adrenal Energy Berberis vulgarius, Agaricus muscarius, Urtica urens, Glandula suprarenalis, Spleen, Echinacea angustifolia, Atropinum sulphuricum, Ceanothus americanus, LIQUID ORAL 20100122 UNAPPROVED HOMEOPATHIC Apotheca Company AMANITA MUSCARIA VAR. MUSCARIA; ATROPINE SULFATE; BERBERIS VULGARIS ROOT BARK; CEANOTHUS AMERICANUS LEAF; ECHINACEA ANGUSTIFOLIA; SUS SCROFA ADRENAL GLAND; SUS SCROFA SPLEEN; URTICA URENS 30; 30; 3; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0063_78221b69-4418-48f7-98c8-014c18f821b1 57520-0063 HUMAN OTC DRUG Cold and Flu Solution Cold and Flu Solution LIQUID ORAL 20100205 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ATROPA BELLADONNA; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT 3; 3; 200; 3; 3; 4; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0064_df43a058-a90c-4f15-8e83-e37d0dd0026f 57520-0064 HUMAN OTC DRUG Cerebraplex Avena sativa, Capsicum annuum, Hydrocotyle asiatica, Fo-ti, Ginkgo biloba, Rosmarinus officinalis, Vinca minor, Brain, Baryta carbonica, LIQUID ORAL 20100208 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; CENTELLA ASIATICA; CHILI PEPPER; DATURA STRAMONIUM; FALLOPIA MULTIFLORA ROOT; GERMANIUM SESQUIOXIDE; GINKGO; PORK BRAIN; POTASSIUM PHOSPHATE, DIBASIC; ROSEMARY; VINCA MINOR 12; 3; 12; 3; 3; 12; 3; 12; 3; 6; 12; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0065_c55b60c7-9b20-45ce-a315-e1a19d44b503 57520-0065 HUMAN OTC DRUG Cerebroforce Cerebroforce LIQUID ORAL 20100208 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; CHILI PEPPER; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC 30; 3; 12; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0066_25306a12-637b-4cdc-9d0e-2eb8680083c5 57520-0066 HUMAN OTC DRUG Chemtox Triticum aestivum, Berberis vulgaris, Glycyrrhiza glabra, Lappa major, Phytolacca decandra, Rhamnus frangula, LIQUID ORAL 20100209 UNAPPROVED HOMEOPATHIC Apotheca Company ACETIC ACID; ARCTIUM LAPPA ROOT; ASPIRIN; ATROPA BELLADONNA; BEEF LIVER; BENZOIC ACID; BENZYL ALCOHOL; BERBERIS VULGARIS ROOT BARK; BORIC ACID; CHLORINE; CORTICOTROPIN; CORTISONE ACETATE; ESTRONE; EUGENOL; FRANGULA ALNUS BARK; FRANGULA ALNUS BARK; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LEAD; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PETROLATUM; PHENYLBUTAZONE; PHOSPHORIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM SORBATE; RED CLOVER; RESORCINOL; SORBITOL; STEARYL ALCOHOL; STILLINGIA; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; THYROID; TRITICUM AESTIVUM POLLEN; XYLITOL; ZANTHOXYLUM AMERICANUM BARK 200; 3; 200; 12; 8; 200; 200; 3; 200; 200; 200; 200; 200; 200; 3; 3; 3; 3; 200; 200; 200; 12; 12; 200; 200; 12; 12; 3; 200; 3; 200; 200; 200; 3; 12; 8; 8; 8; 1; 200; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0067_2524f404-07b4-49e3-97d7-47bd815080d6 57520-0067 HUMAN OTC DRUG Circulatone Fagopyrum esculentum, Magnesia muriatica LIQUID ORAL 20100209 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; ARSENIC TRIIODIDE; BARIUM CHLORIDE DIHYDRATE; BEEF HEART; CALCIUM IODIDE; CHOLESTEROL; CITRUS BIOFLAVONOIDS; CONIUM MACULATUM FLOWERING TOP; FAGOPYRUM ESCULENTUM; GOLD TRICHLORIDE; LEAD; MAGNESIUM CHLORIDE; PHOSPHORUS; POTASSIUM IODIDE; THYROID 30; 12; 12; 8; 12; 12; 8; 12; 3; 12; 12; 3; 30; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0069_5275983b-97db-46af-9a3c-dd399b141d48 57520-0069 HUMAN OTC DRUG Contact Allergy Rhus toxicodendron, Rhus diversiloba, Rhus venenate, Uritica dioica, Anacardium orientale, Graphites, LIQUID ORAL 20100209 UNAPPROVED HOMEOPATHIC Apotheca Company DAPHNE MEZEREUM BARK; GRAPHITE; SEMECARPUS ANACARDIUM JUICE; TOXICODENDRON DIVERSILOBUM LEAF; TOXICODENDRON PUBESCENS LEAF; TOXICODENDRON VERNIX LEAFY TWIG; URTICA DIOICA; XEROPHYLLUM ASPHODELOIDES 12; 12; 12; 30; 30; 30; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0070_bab18474-03a1-40aa-b33f-dcbce4521fbe 57520-0070 HUMAN OTC DRUG Convoforce Belladonna, Bufo vulgaris, Cicuta virosa, Cina, Cuprum metallicum, Hyoscyamus niger, Muschus, Stramonium, LIQUID ORAL 20100209 UNAPPROVED HOMEOPATHIC Apotheca Company ARTEMISIA CINA FLOWER; ATROPA BELLADONNA; BUFO BUFO CUTANEOUS GLAND; CICUTA VIROSA ROOT; COPPER; DATURA STRAMONIUM; HYOSCYAMUS NIGER; MOSCHUS MOSCHIFERUS MUSK SAC RESIN 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0071_128989f0-8ade-4b30-966a-41f376739879 57520-0071 HUMAN OTC DRUG Cough-HP Cough-HP LIQUID ORAL 20100209 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPECAC; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0075_80238f18-057d-4608-9bf0-8e6cd2755a3e 57520-0075 HUMAN OTC DRUG CV HP Lycopus virginicus, Valeriana officinalis, Aurum metallicum, Cactus grandiflorus, Cuprum aceticum, LIQUID ORAL 20100210 UNAPPROVED HOMEOPATHIC Apotheca Company CUPRIC ACETATE; DIGITALIS; GOLD; LYCOPUS; PHOSPHORUS; PULSATILLA VULGARIS; SELENICEREUS GRANDIFLORUS STEM; SODIUM CHLORIDE; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 57520-0076_a1745a97-beb6-4b8b-ab48-e8b2626a6736 57520-0076 HUMAN OTC DRUG Cystoforce Cystoforce LIQUID ORAL 20100210 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ARCTOSTAPHYLOS UVA-URSI LEAF; ARSENIC TRIOXIDE; CALCIUM SULFIDE; LYTTA VESICATORIA; SARSAPARILLA; SOLIDAGO VIRGAUREA FLOWERING TOP 12; 3; 12; 12; 12; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0077_129dde64-7be3-4373-8be6-8a6fab02b86a 57520-0077 HUMAN OTC DRUG Cystoges Berberis vulgaris, Cantharis, Clematis erecta LIQUID ORAL 20100210 UNAPPROVED HOMEOPATHIC Apotheca Company BERBERIS VULGARIS FRUIT; CANIS LUPUS FAMILIARIS MILK; CLEMATIS RECTA FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PULSATILLA VULGARIS; SARSAPARILLA; SEPIA OFFICINALIS JUICE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0079_f4f66c52-3aa7-4153-a696-98a5b68aae08 57520-0079 HUMAN OTC DRUG Dentox Berberis vulgaris, Glycyrrhiza glabra, Lappa major, Phytolacca decandra, Stillingia sylvatica, Trifolium pratense, Lymph (suis), Medulla ossis (suis), Thymus (suis), LIQUID ORAL 20100210 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTIUM LAPPA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM FLUORIDE; COPPER; EUGENOL; FORMALDEHYDE; GLYCYRRHIZA GLABRA; GOLD; LIDOCAINE; MERCURIUS SOLUBILIS; MOLYBDENUM; NICKEL; PALLADIUM; PHYTOLACCA AMERICANA ROOT; SILVER; SODIUM FLUORIDE; STILLINGIA SYLVATICA ROOT; SUS SCROFA BONE MARROW; SUS SCROFA LYMPH; SUS SCROFA THYMUS; THYROID, PORCINE; TIN; TITANIUM; TRIFOLIUM PRATENSE FLOWER; ZINC 3; 3; 12; 12; 12; 12; 3; 200; 12; 12; 12; 12; 12; 3; 12; 12; 3; 8; 8; 8; 8; 12; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0080_3dd132e1-cb3b-4df3-97d3-8a49848e89fe 57520-0080 HUMAN OTC DRUG Depressoforce Depressoforce LIQUID ORAL 20100210 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; GOLD; NITRIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; TRINITROPHENOL 30; 30; 30; 30; 30; 30; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0081_b5372a70-02e6-4dfa-9d12-2d313eea52bb 57520-0081 HUMAN OTC DRUG Drainage Drainage LIQUID ORAL 20100211 UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM IODIDE; ECHINACEA ANGUSTIFOLIA; NITRIC ACID; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; POTASSIUM CHLORIDE; RED CLOVER; SULFUR IODIDE 12; 3; 12; 12; 3; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; kg/mL; [hp_X]/mL; [hp_X]/mL 57520-0083_13eb520c-85f6-489a-a505-c8940d3a34b6 57520-0083 HUMAN OTC DRUG Diabenex HP Colchicum autumnale, Lacticum acidum, Lycopodium clavatum, Phosphoricum acidum, Phosphorus, Syzygium jambolanum, Uranium Nitricum, LIQUID ORAL 20100211 UNAPPROVED HOMEOPATHIC Apotheca Company COLCHICUM AUTUMNALE BULB; LACTIC ACID, DL-; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0085_047a4491-0e18-4f80-a6ed-2754ca6d4ae4 57520-0085 HUMAN OTC DRUG Diathesis Pancreas, Spleen, Stomach, Ginkgo biloba, Germanium sesquioxide, Cuprum metallicum LIQUID ORAL 20100212 UNAPPROVED HOMEOPATHIC Apotheca Company .ALPHA.-KETOGLUTARIC ACID; BIS(CARBOXYETHYL)GERMANIUM SESQUIOXIDE; COPPER; CYSTEINE; FUMARIC ACID; GINKGO; MANGANESE GLUCONATE; SODIUM DIETHYL OXALACETATE; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA STOMACH; ZINC 12; 8; 9; 9; 12; 6; 10; 12; 30; 30; 30; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0088_91d78c17-bd3f-4a63-a69d-9b5a46f604fa 57520-0088 HUMAN OTC DRUG Ear Ear LIQUID ORAL 20100215 UNAPPROVED HOMEOPATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; CHILI PEPPER; ECHINACEA; FERRUM PHOSPHORICUM; GOLDENSEAL; MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; POTASSIUM CHLORIDE; PULSATILLA VULGARIS 3; 12; 3; 12; 3; 12; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0089_a7d61d17-d2af-47bb-88ba-673ace756af2 57520-0089 HUMAN OTC DRUG Eczema Arsenicum album, Calcarea carbonica, Graphites LIQUID ORAL 20100215 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; DAPHNE MEZEREUM BARK; GRAPHITE; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE; SULFUR; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0090_f0ae81c6-393e-4fdd-b33b-87c17f0edbbc 57520-0090 HUMAN OTC DRUG Eczemaforce Lappa major, Phytolacca decandra, Trifolium pratense LIQUID ORAL 20100215 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; CENTELLA ASIATICA; DAPHNE MEZEREUM BARK; GRAPHITE; PHYTOLACCA AMERICANA ROOT; RED CLOVER 3; 12; 6; 12; 12; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0091_dc083c3b-7f12-4c7c-85be-84cd7b2b6a05 57520-0091 HUMAN OTC DRUG Edema-HP Edema-HP LIQUID ORAL 20100215 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ARSENIC TRIOXIDE; DIGITALIS; IRON; LYCOPODIUM CLAVATUM SPORE; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0092_3e601df3-668a-453b-b23c-6ba10bfacd57 57520-0092 HUMAN OTC DRUG Endocrine Balancer Endocrine Balancer LIQUID ORAL 20100215 UNAPPROVED HOMEOPATHIC Apotheca Company FUCUS VESICULOSUS; GLYCYRRHIZA GLABRA; IODINE; PINUS SYLVESTRIS TOP; SARSAPARILLA; SUS SCROFA ADRENAL GLAND; THYROID 3; 3; 12; 6; 3; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0094_41eb24a4-37a4-4826-a595-540a4cf7d562 57520-0094 HUMAN OTC DRUG Estrogen Folliculinum, Oophorinum, LIQUID ORAL 20100216 UNAPPROVED HOMEOPATHIC Apotheca Company ESTRONE; SUS SCROFA OVARY 30; 30 [hp_C]/mL; [hp_C]/mL 57520-0095_dfd902c7-7bdc-467e-959d-02122ed60c15 57520-0095 HUMAN OTC DRUG Evtox Cochlearia officinalis, Echinacea angustifolia, Hydrastis canadensis, Lomatium, Tabebuia impetiginosa, Propolis, Glandula suprarenalis, Thymus, Aranea diadema, LIQUID ORAL 20100217 UNAPPROVED HOMEOPATHIC Apotheca Company ARANEUS DIADEMATUS; COCHLEARIA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 4; HYDROCHLORIC ACID; IPECAC; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PROPOLIS WAX; SILICON DIOXIDE; SUS SCROFA ADRENAL GLAND; TABEBUIA IMPETIGINOSA BARK; THYMUS; TOXICODENDRON PUBESCENS LEAF 12; 3; 3; 3; 200; 30; 60; 12; 12; 3; 12; 12; 6; 12; 8; 3; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0096_803e6900-89af-43cd-90e3-4f8e81681589 57520-0096 HUMAN OTC DRUG Female Balance Female Balance SPRAY ORAL 20100217 UNAPPROVED HOMEOPATHIC Apotheca Company ESTRONE; PROGESTERONE 6; 6 [iU]/mL; [hp_X]/mL 57520-0097_7e53539e-a4fc-4faf-9bb6-27e703274439 57520-0097 HUMAN OTC DRUG Flu Tonic Echinacea angustifolia, Uva-ursi, Baptisia tinctoria, Convallaria majalis, Kali muriaticum, Pinus sylvestris, Thuja occidentalis, Bryonia alba, LIQUID ORAL 20100217 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GINKGO; LACHESIS MUTA VENOM; MARSDENIA CONDURANGO BARK; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM CHLORIDE; SELENIUM; TABEBUIA IMPETIGINOSA BARK; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUIT 1; 3; 12; 6; 12; 1; 12; 12; 12; 6; 6; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0098_fa005acf-20d5-40a7-b631-72611324d9cd 57520-0098 HUMAN OTC DRUG FNG I Echinacea angustifolia, Hydrastis canadensis, Lapachoplex, Lomatium, Nasturtium aquaticum, Propoloplex, Tabebuia impetiginosa, LIQUID ORAL 20100217 UNAPPROVED HOMEOPATHIC Apotheca Company ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; ASTRAGALUS PROPINQUUS ROOT; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA ANGUSTIFOLIA; GINKGO; GOLDENSEAL; LIGUSTICUM PORTERI ROOT; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MARSDENIA CONDURANGO BARK; MUCOR RACEMOSUS; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PROPOLIS WAX; RHIZOPUS STOLONIFER; RORIPPA NASTURTIUM-AQUATICUM; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK 200; 200; 3; 200; 200; 200; 3; 3; 3; 3; 3; 12; 3; 200; 12; 12; 3; 200; 3; 200; 12; 12; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0099_ea9ae9cb-e8f8-4423-89b4-6f1abb867000 57520-0099 HUMAN OTC DRUG FNG II Echinacea angustifolia, Hydrastis canadensis, Lomatium, Nasturtium aquaticum, Tabebuia impetiginosa, Iodium, Adrenalinum, Argentum metallicum LIQUID ORAL 20100217 UNAPPROVED HOMEOPATHIC Apotheca Company CANDIDA ALBICANS; ECHINACEA ANGUSTIFOLIA; EPINEPHRINE; GOLDENSEAL; IODINE; LOMATIUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PULSATILLA VULGARIS; RORIPPA NASTURTIUM-AQUATICUM; SEPIA OFFICINALIS JUICE; SILVER; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; THYROID 30; 3; 8; 3; 6; 3; 30; 12; 30; 3; 30; 8; 8; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0100_803494cd-cde6-4710-a4e0-df6b3430c76a 57520-0100 HUMAN OTC DRUG GABA Gaba, LIQUID ORAL 20100217 UNAPPROVED HOMEOPATHIC Apotheca Company .GAMMA.-AMINOBUTYRIC ACID 30 [hp_C]/mL 57520-0102_b7fd9416-b905-455d-b422-b2448c888335 57520-0102 HUMAN OTC DRUG Grippe-HP Grippe-HP LIQUID ORAL 20100218 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0103_58a3cc7b-c517-4fea-997c-bdf8cc4e90f4 57520-0103 HUMAN OTC DRUG Gynetox Angelica archangelica, Cimicifuga racemosa, Zincum gluconicum, Funiculus umbilicalis suis, Lymph node, Oophorinum, Uterus, Glandula suprarenalis, Thyroidinum, LIQUID ORAL 20100218 UNAPPROVED HOMEOPATHIC Apotheca Company ANGELICA ARCHANGELICA ROOT; BLACK COHOSH; BORIC ACID; CANDIDA ALBICANS; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN PAPILLOMAVIRUS; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SAVIN; SEPIA OFFICINALIS JUICE; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA OVARY; SUS SCROFA UMBILICAL CORD; SUS SCROFA UTERUS; THYROID; WOOD CREOSOTE; ZINC GLUCONATE 3; 3; 12; 60; 60; 60; 60; 12; 30; 30; 12; 30; 12; 9; 8; 8; 8; 8; 9; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0104_e4aac6c6-7441-4995-bbd7-d076073eb31d 57520-0104 HUMAN OTC DRUG Gynobalance Gynobalance SPRAY ORAL 20100218 UNAPPROVED HOMEOPATHIC Apotheca Company ESTRADIOL; PRASTERONE; PREGNENOLONE; PROGESTERONE; TESTOSTERONE 8; 6; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0105_7a6ab07a-8069-41b0-a166-07acdb39cc0a 57520-0105 HUMAN OTC DRUG HA HP Belladonna, Bryonia alba, Gelsemium sempervirens, Glonoinum, Melilotus officinalis, LIQUID ORAL 20100218 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; MELILOTUS OFFICINALIS POLLEN; NITROGLYCERIN; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0106_7baecb66-b21c-42a1-ae8b-4c45820cc689 57520-0106 HUMAN OTC DRUG Flu-Cold Flu-Cold LIQUID ORAL 20100218 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 12; 12; 3; 12; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; kg/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0107_136ff027-de7c-4bb1-8b04-0ffee6f80bb3 57520-0107 HUMAN OTC DRUG Hayfever Tonic Echinacea purpurea, Hydrastis canadensis, Eupatorium perfoliatum, Verbascum thapsus, Ailanthus glandulosus, Allium cepa, Ambrosia artemisiaefolia, Aurum muriaticum, LIQUID ORAL 20100218 UNAPPROVED HOMEOPATHIC Apotheca Company ACER NEGUNDO POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA FLOWERING TWIG; ALFALFA; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA OCCIDENTALIS POLLEN; CAMPHOR (NATURAL); CARYA TOMENTOSA POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA PURPUREA; ELM; EUPATORIUM PERFOLIATUM FLOWERING TOP; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; GOLD TRICHLORIDE; GOLDENSEAL; IPECAC; JUGLANS NIGRA POLLEN; ONION; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; POTASSIUM DICHROMATE; QUERCUS RUBRA POLLEN; RED CLOVER; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS TOP; SALIX NIGRA POLLEN; SOLIDAGO VIRGAUREA FLOWERING TOP; SOLIDAGO VIRGAUREA POLLEN; VERBASCUM THAPSUS 30; 30; 12; 30; 30; 12; 30; 30; 30; 12; 30; 30; 3; 30; 12; 30; 30; 12; 3; 12; 30; 12; 30; 30; 30; 30; 12; 30; 30; 30; 30; 30; 12; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [iU]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0108_e0bc2d56-7e9a-4a95-b247-3210f82f4c47 57520-0108 HUMAN OTC DRUG Hemoforce Urtica urens, Ferrum muriaticum, Aranea diadema, Aurum metallicum, Cinchona officinalis, Cobaltum gluconate, Phosphorus, LIQUID ORAL 20100219 UNAPPROVED HOMEOPATHIC Apotheca Company ARANEUS DIADEMATUS; CINCHONA OFFICINALIS BARK; COBALTOUS GLUCONATE; FERRIC CHLORIDE HEXAHYDRATE; GOLD; PHOSPHORUS; URTICA URENS 12; 12; 12; 6; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0109_68df356d-b78e-464a-9c6c-bed347646d17 57520-0109 HUMAN OTC DRUG Hepataforce Carduus marianus, Chelidonium majus, Taraxacum officinale, Lycopodium clavatum, Magnesia phosphorica, Natrum sulphuricum, LIQUID ORAL 20100219 UNAPPROVED HOMEOPATHIC Apotheca Company CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILYBUM MARIANUM SEED; SODIUM SULFATE; TARAXACUM OFFICINALE 3; 12; 12; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0110_0d387ed4-d6ed-4c09-90c9-e1d750ef99ba 57520-0110 HUMAN OTC DRUG Hepataplex Hepataplex LIQUID ORAL 20100219 UNAPPROVED HOMEOPATHIC Apotheca Company BETA VULGARIS; CHELIDONIUM MAJUS; GLUTATHIONE; LYCOPODIUM CLAVATUM SPORE; PETROSELINUM CRISPUM; PEUMUS BOLDUS LEAF; PHOSPHORUS; PORK LIVER; SILYBUM MARIANUM SEED; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 3; 3; 6; 12; 3; 3; 12; 6; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [iU]/mL; [hp_X]/mL; [hp_X]/mL 57520-0111_7d0e258f-0f4c-4c0f-84c5-fddd13c91597 57520-0111 HUMAN OTC DRUG Hepatatox Triticum aestivum, Chelidonium majus, Taraxacum officinale, Glutathione, Hepar bovinum, LIQUID ORAL 20100219 UNAPPROVED HOMEOPATHIC Apotheca Company ACETIC ACID; BEEF LIVER; BENZOIC ACID; BENZYL ALCOHOL; BORIC ACID; CHELIDONIUM MAJUS; CHLORINE; CORTICOTROPIN; CORTISONE ACETATE; ESTRONE; EUGENOL; GLUTATHIONE; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LEAD; LYCOPODIUM CLAVATUM SPORE; PETROLATUM; PHENYLBUTAZONE; PHOSPHORIC ACID; POTASSIUM SORBATE; RESORCINOL; SALICYLIC ACID; SORBITOL; STEARYL ALCOHOL; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; THYROID; TRITICUM AESTIVUM POLLEN; XYLITOL 200; 8; 200; 200; 200; 3; 200; 200; 200; 200; 200; 6; 200; 200; 200; 12; 200; 200; 12; 200; 200; 200; 200; 200; 12; 3; 8; 1; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [iU]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0112_77bceb5a-7023-44ec-b751-f67ddc218bc4 57520-0112 HUMAN OTC DRUG Histamine Histaminum hydrochloricum LIQUID ORAL 20100219 UNAPPROVED HOMEOPATHIC Apotheca Company HISTAMINE DIHYDROCHLORIDE 30 [hp_C]/mL 57520-0114_7a0330cd-97f2-4eb3-ae14-06350a86ab43 57520-0114 HUMAN OTC DRUG Hydrate I Coffea tosta, Ginkgo biloba, Germanium sesquioxide, Silicea, LIQUID ORAL 20100222 UNAPPROVED HOMEOPATHIC Apotheca Company COFFEE BEAN; GERMANIUM SESQUIOXIDE; GINKGO; SILICON DIOXIDE 1; 8; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0115_46fc331a-bdef-4dbb-a6a7-97ee81717dfb 57520-0115 HUMAN OTC DRUG Hydrate II Coffea tosta, Avena sativa, Equisetum hyemale, Hypericum perforatum, Ginkgo biloba, Germanium sesquioxide, Silicea, LIQUID ORAL 20100222 UNAPPROVED HOMEOPATHIC Apotheca Company AVENA SATIVA FLOWERING TOP; COFFEE BEAN; EQUISETUM HYEMALE; GERMANIUM SESQUIOXIDE; GINKGO; HYPERICUM PERFORATUM; SILICON DIOXIDE 3; 1; 3; 8; 6; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0117_61ac297c-4a70-4b84-9a57-eefd6bc3bfcf 57520-0117 HUMAN OTC DRUG Hypopituitaryplex Aralia quinquefolia, Hydrocotyle asiatica, Polygonum multiflorum, Hypothalamus, Pituitarum posterium, Germanium sesquioxide, Pineal, LIQUID ORAL 20100222 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; CENTELLA ASIATICA; FALLOPIA MULTIFLORA ROOT; GERMANIUM SESQUIOXIDE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND 3; 3; 3; 12; 8; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0119_845b8959-4553-4e54-939f-e27a228c7075 57520-0119 HUMAN OTC DRUG HZ Formula Baptisia tinctoria, Echinacea angustifolia, Lomatium, Tabebuia impetiginosa, Propolis, Spleen, Thymus, Thyrodinum, LIQUID ORAL 20100222 UNAPPROVED HOMEOPATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; CANDIDA ALBICANS; CHLAMYDIA TRACHOMATIS; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN PAPILLOMAVIRUS; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; PROPOLIS WAX; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA SPLEEN; TABEBUIA IMPETIGINOSA BARK; THYMUS; THYROID; TRICHINELLA SPIRALIS 3; 200; 200; 3; 12; 200; 200; 200; 3; 12; 6; 12; 6; 3; 6; 6; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0120_ab616edf-5203-4e4a-b2c6-4ce329c35f69 57520-0120 HUMAN OTC DRUG Immune Forte Dehydro-epi-androsterone(DHEA), Estradiol, Pituitarum posterium, Pregnenolone, Progesterone, Spleen, Testosterone, SPRAY ORAL 20100222 UNAPPROVED HOMEOPATHIC Apotheca Company ESTRADIOL; PRASTERONE; PREGNENOLONE; PROGESTERONE; SUS SCROFA PITUITARY GLAND; SUS SCROFA SPLEEN; TESTOSTERONE; THYMUS; THYROID 8; 8; 8; 8; 8; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0123_a927b613-1661-4f28-afc4-846b9a44b539 57520-0123 HUMAN OTC DRUG Inflammation II Astragalus membranaceus, Echinacea angustifolia LIQUID ORAL 20100223 UNAPPROVED HOMEOPATHIC Apotheca Company ASTRAGALUS PROPINQUUS ROOT; CARBO ANIMALIS; CAUSTICUM; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; GOLD; GOLDENSEAL; PHOSPHORUS; SARSAPARILLA; SODIUM SULFATE; SULFUR; TABEBUIA IMPETIGINOSA BARK; THUJA OCCIDENTALIS TWIG; THYROID 3; 12; 12; 3; 30; 12; 3; 30; 3; 30; 30; 3; 30; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0128_0daf352e-d341-48a8-9bd8-3f1d9747e5e7 57520-0128 HUMAN OTC DRUG Intestaforce Intestaforce LIQUID ORAL 20100323 UNAPPROVED HOMEOPATHIC Apotheca Company ALTHAEA OFFICINALIS ROOT; CHILI PEPPER; COMFREY ROOT; FENNEL SEED; FERRUM PHOSPHORICUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS; SILVER NITRATE 3; 3; 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0129_bbb69317-09c5-4744-8358-2c03ceab0ae1 57520-0129 HUMAN OTC DRUG Teething Arnica Montana, Trifolium pratense, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Chamomilla, Kreosotum, Silicea, LIQUID ORAL 20100305 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; CALCIUM FLUORIDE; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; RED CLOVER; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE; WOOD CREOSOTE 3; 12; 12; 12; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0130_65e6129f-68f4-4b39-b8fa-4d22736ad970 57520-0130 HUMAN OTC DRUG Bio Rock Rose Rock rose, LIQUID ORAL 20100305 UNAPPROVED HOMEOPATHIC Apotheca Company HELIANTHEMUM NUMMULARIUM FLOWER 200 [hp_C]/mL 57520-0131_f62cc8bc-10b9-4c63-8831-6ae27211befb 57520-0131 HUMAN OTC DRUG Pneumo HP Ammonium muriaticum, Antimonium tartaricum, Arsenicum album, Calcarea Carbonica, Lobelia inflata, Natrum sulphuricum, Spongia tosta, Phosphorus, LIQUID ORAL 20100304 UNAPPROVED HOMEOPATHIC Apotheca Company AMMONIUM CHLORIDE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; LOBELIA INFLATA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 57520-0133_c0e34435-7ef4-409a-897a-076f81d44240 57520-0133 HUMAN OTC DRUG Sinus Clear Hepar sulphuris calcareum, Kali bichromicum, Pulsatilla, Silicea, CAPSULE ORAL 20101108 UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM SULFIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57520-0134_67f2d48b-e402-4b46-83b0-9b17574f7478 57520-0134 HUMAN OTC DRUG Sinus Clear Hepar sulphuris calcareum, Kali bichromicum, Pulsatilla, Silicea, CAPSULE ORAL 20101104 UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM SULFIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57520-0136_713ba513-6b9e-47ad-99d4-938ca90edccc 57520-0136 HUMAN OTC DRUG LGB HP Chelidonium majus, Lycopodium clavatum, Nux vomica, Phosphorus, Natrum sulphuricum, colocynthis, veratrum album, LIQUID ORAL 20100721 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0137_17964fbb-a157-45ba-96f0-15f7b7b5af6a 57520-0137 HUMAN OTC DRUG Healing Support Betula pendula cortex, Caltha palustris, Galium aparine, Sedum acre, Thuja occidentalis, Urtica urens, LIQUID ORAL 20100315 20160207 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; BETULA PENDULA BARK; CALCIUM FLUORIDE; CALTHA PALUSTRIS; CLEMATIS RECTA FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; HEDERA HELIX FLOWERING TWIG; JUNIPER; NITRIC ACID; ONONIS CAMPESTRIS; PHOSPHORUS; QUILLAJA SAPONARIA BARK; RANCID BEEF; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; SILVER; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 12; 2; 8; 3; 4; 5; 3; 4; 4; 6; 4; 8; 4; 12; 3; 4; 8; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0138_d92c3601-1c0d-44d8-ac1e-0bac54c5a579 57520-0138 HUMAN OTC DRUG Optimal HCG Fucus vesiculosus, Cyanocobalamin, Glandula suprarenalis suis, Hepar suis, L-carnitine, Ornithine, Antimonium crudum, LIQUID ORAL 20100819 UNAPPROVED HOMEOPATHIC Apotheca Company ANTIMONY TRISULFIDE; CYANOCOBALAMIN; FUCUS VESICULOSUS; HUMAN CHORIONIC GONADOTROPIN; LEVOCARNITINE; ORNITHINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PANCRELIPASE; PORK LIVER; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA THYROID 8; 6; 2; 60; 30; 30; 12; 12; 6; 10; 6; 18; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0139_26b7a34d-bbaa-4938-8737-c7bab1b3de6f 57520-0139 HUMAN OTC DRUG Arthritis HP Apis mellifica, Bryonia alba, Causticum, Colchicum autumnale, Kalmia latifolia, Ledum palustre LIQUID ORAL 20100805 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; BRYONIA ALBA ROOT; CAUSTICUM; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0140_417028ec-c6d9-4b96-a1d1-228c99671afc 57520-0140 HUMAN OTC DRUG Total Body Detox Citrus limonum, Taraxacum officinale, Uva-ursi, Berberis vulgaris, Capsicum annuum, Galium aparine, Lobelia inflata, Nux vomica, Schisandra, Tylophora, Brain, Cor suis, Glandula suprarenalis suis, LIQUID ORAL 20100311 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS FRUIT; CALCIUM SULFIDE; CAPSICUM; GALIUM APARINE; LACTIC ACID, DL-; LEMON JUICE; LOBELIA INFLATA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PORK BRAIN; PORK HEART; PORK INTESTINE; PORK KIDNEY; PORK LIVER; SCHISANDRA CHINENSIS FRUIT; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA LUNG; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; TARAXACUM OFFICINALE; THYROID; TYLOPHORA INDICA ROOT 2; 3; 8; 3; 3; 8; 1; 3; 8; 8; 8; 8; 8; 8; 6; 3; 8; 8; 8; 8; 2; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0141_cc043629-0e88-4df1-b0d5-365649b43ace 57520-0141 HUMAN OTC DRUG Thyro T3 Rescue Spongia tosta, Iodium Fucus vesiculosus, Belladonna, Adenosine triphosphate, Parathyroid, LIQUID ORAL 20100312 UNAPPROVED HOMEOPATHIC Apotheca Company ADENOSINE TRIPHOSPHATE; ATROPA BELLADONNA; BEEF LIVER; FUCUS VESICULOSUS; IODINE; LEVOTHYROXINE; LIOTHYRONINE; PORK KIDNEY; SELENIUM; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PARATHYROID GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID 3; 200; 30; 1; 1; 3; 3; 30; 8; 6; 30; 8; 30; 30; 1 [hp_Q]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL 57520-0143_02d86a85-bd06-4f30-b0f4-76b3f68f5af2 57520-0143 HUMAN OTC DRUG Endopure Testos-Male DNA, RNA, Cortisol, Glandula suprarenalis, Hypothalamus, Pitrutary, Prostate, Testosterone, LIQUID ORAL 20100402 UNAPPROVED HOMEOPATHIC Apotheca Company CHELIDONIUM MAJUS; HERRING SPERM DNA; HYDROCORTISONE; SACCHAROMYCES CEREVISIAE RNA; SAW PALMETTO; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; TESTOSTERONE; THUJA OCCIDENTALIS LEAFY TWIG 12; 6; 6; 6; 12; 6; 6; 6; 6; 12; 30 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0144_93793271-55d2-48b4-a921-83f1759236ce 57520-0144 HUMAN OTC DRUG Neuro Balance Pro Adrenocorticotrophin, Gaba, Glutamic acid, Norepinephrine, Acetylcholine chloride, Adrenalinum SPRAY ORAL 20100407 UNAPPROVED HOMEOPATHIC ApothecaCompany .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; BARIUM CARBONATE; CORTICOTROPIN; DATURA STRAMONIUM; EPINEPHRINE; GLUTAMIC ACID; LEVODOPA; NOREPINEPHRINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEMECARPUS ANACARDIUM JUICE; SEROTONIN; THYROID 3; 1; 200; 30; 1; 1; 3; 1; 30; 200; 200; 1; 12 [hp_C]/mL; [hp_M]/mL; [hp_C]/mL; [hp_X]/mL; [hp_M]/mL; [hp_M]/mL; [hp_C]/mL; [hp_M]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_M]/mL; [hp_C]/mL 57520-0148_e5a18936-eb3d-409f-b00d-1a22396bbe47 57520-0148 HUMAN OTC DRUG Inflammation I Inflammation I LIQUID ORAL 20100309 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; FERRUM PHOSPHORICUM; GOLDENSEAL; NERIUM OLEANDER LEAF; NITRIC ACID; PHYTOLACCA AMERICANA ROOT; RORIPPA NASTURTIUM-AQUATICUM; SILICON DIOXIDE 12; 12; 3; 12; 3; 12; 12; 3; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0149_fcd79216-363c-4e46-941a-1860644fb493 57520-0149 HUMAN OTC DRUG L-Dopa L-dopa LIQUID ORAL 20100317 UNAPPROVED HOMEOPATHIC Apotheca Company LEVODOPA 30 [hp_C]/mL 57520-0150_8a841ae0-2af9-450c-89b6-8e747d7f358f 57520-0150 HUMAN OTC DRUG Liver Tonic II Boldo, Carduus marianus, Curcuma, Echinacea angustifolia, Taraxacum officinale, Magnesia phosphorica, Gallbladder, LIQUID ORAL 20100308 UNAPPROVED HOMEOPATHIC Apotheca Company AMMI VISNAGA FRUIT; ATROPINE SULFATE; BEEF LIVER; CHELIDONIUM MAJUS; CULVER'S ROOT; ECHINACEA ANGUSTIFOLIA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PEUMUS BOLDUS LEAF; PODOPHYLLUM PELTATUM ROOT; SILYBUM MARIANUM SEED; SUS SCROFA GALLBLADDER; TARAXACUM OFFICINALE; TURMERIC; TURMERIC 12; 12; 200; 12; 12; 1; 8; 1; 12; 1; 200; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0151_85807442-9511-4e8b-9382-72d592027786 57520-0151 HUMAN OTC DRUG Lymphoplex Myrrha, Trigonella foenum-graecum, Pinus sylvestris, Lymph, Spleen, Conium maculatum, Echinacea Angustifolia, Hepar sulphuris calcareum, Hydrangea arborescens, Phytolacca decandra, Silicea, LIQUID ORAL 20100315 UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; FENUGREEK SEED; HYDRANGEA; MYRRH; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS TOP; SILICON DIOXIDE; SUS SCROFA LYMPH; SUS SCROFA SPLEEN 12; 12; 12; 3; 12; 3; 12; 6; 12; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0152_9132903b-d692-402f-b41d-f2c96d031744 57520-0152 HUMAN OTC DRUG Apizelen Alfalfa, Avena sativia, Chelidonium majus, Aralia quinquefolia, Beta vulgaris, Calendula officinalis, Cuprum aceticum, LIQUID ORAL 20100317 UNAPPROVED HOMEOPATHIC Apotheca Company ALFALFA; AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; BETA VULGARIS; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; COBALT; COBALTOUS GLUCONATE; COPPER GLUCONATE; CUPRIC ACETATE; ECHINACEA; GERMANIUM; GLUTATHIONE; LING; MAGNESIUM GLUCONATE; OXALIS ACETOSELLA; PHYTOLACCA AMERICANA ROOT; RED CLOVER; SILVER; SODIUM CHLORIDE; UBIDECARENONE; URTICA DIOICA; VISCUM ALBUM FRUITING TOP 1; 2; 1; 2; 2; 1; 3; 3; 3; 2; 2; 6; 3; 4; 3; 2; 2; 2; 6; 2; 3; 2; 2 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0153_c8719688-b3b7-40ea-b89b-5c7d9a884426 57520-0153 HUMAN OTC DRUG Testosterone Testosterone, TABLET ORAL 20100510 20151110 UNAPPROVED HOMEOPATHIC Apothecca Company TESTOSTERONE 30 [hp_X]/5mg 57520-0154_cccabf04-6888-4c58-98dd-168cbbc0549e 57520-0154 HUMAN OTC DRUG Iodine Plus Capsule Thyroidinum, Thyroxine, Trilodothyronine, CAPSULE ORAL 20100713 UNAPPROVED HOMEOPATHIC Apotheca Company LEVOTHYROXINE; LIOTHYRONINE; THYROID 30; 200; 30 [hp_X]/mg; [hp_C]/mg; [hp_X]/mg 57520-0156_88f3e94a-050b-4897-9a32-8d47d19ccf0e 57520-0156 HUMAN OTC DRUG Pre Post Surgery HP Arnica montana, Bellis perennis, Bryonia, Calendula officinalis, Hypericum perforatum, Ledum palustre, Phosphorus, Pyrogenium, Rhus toxicodendron, LIQUID ORAL 20101001 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; RANCID BEEF; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 3; 12; 12; 12; 12; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0157_c8b67091-950b-477e-9a6a-268704b521d3 57520-0157 HUMAN OTC DRUG Sore Throat Echinacea purpurea, Plantago major, Baptisia tinctoria SPRAY ORAL 20100625 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; ECHINACEA PURPUREA; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR 12; 12; 3; 15; 2; 12; 12; 3; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0158_e516926d-01d3-45cc-9977-d031cf4c2279 57520-0158 HUMAN OTC DRUG Shark Cartilage Shark cartilage LIQUID ORAL 20100714 UNAPPROVED HOMEOPATHIC Apotheca Company SHARK 12 [hp_X]/mL 57520-0160_db7177c2-aa07-45da-9f7f-208d078d6397 57520-0160 HUMAN OTC DRUG Inflammation Mangosteen, Acai, Aronia, Olibanum,, Aconitum napellus, Bryonia, Humulus lupulus, SPRAY ORAL 20100813 UNAPPROVED HOMEOPATHIC Apotheca Company ACAI; ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; BRYONIA ALBA ROOT; FRANKINCENSE; GOLDENSEAL; HOPS; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 3; 6; 200; 200; 6; 3; 6; 6; 200; 8; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 57520-0161_ecc48202-a2b1-421b-9de3-92f1b65dfb8c 57520-0161 HUMAN OTC DRUG homeopathic HCG Cyanocobalamin, L-carnitine, Ornithine, Human chorionic gonadotropin, SPRAY ORAL 20100902 UNAPPROVED HOMEOPATHIC Apotheca Company CYANOCOBALAMIN; HUMAN CHORIONIC GONADOTROPIN; LEVOCARNITINE; ORNITHINE 6; 60; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0164_dc25b5ef-d8df-4919-a7d6-e1aa799185e1 57520-0164 HUMAN OTC DRUG Candida Alb Candida albicans, LIQUID ORAL 20101008 UNAPPROVED HOMEOPATHIC Apotheca Company CANDIDA ALBICANS 60 [hp_X]/mL 57520-0166_7686299f-f0fe-4380-9e60-6db57382e74c 57520-0166 HUMAN OTC DRUG Epstein Barr Virus Remedy Epstein Barr Virus Remedy 200X LIQUID NOT APPLICABLE 20100319 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN HERPESVIRUS 4 200 [hp_X]/mL 57520-0167_3aa0436a-15ca-4667-a5b2-64f9d7d54924 57520-0167 HUMAN OTC DRUG Epstein Barr Virus Remedy Epstein Barr Virus Remedy 100X LIQUID NOT APPLICABLE 20100319 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN HERPESVIRUS 4 100 [hp_X]/mL 57520-0168_e64bdacf-5b8a-4676-b489-b0d3e65970aa 57520-0168 HUMAN OTC DRUG Epstein Barr Virus Remedy Epstein-barr virus LIQUID ORAL 20100319 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN HERPESVIRUS 4 60 [hp_X]/mL 57520-0169_ab7b718b-e740-40e9-9ed9-1330d34c0bee 57520-0169 HUMAN OTC DRUG Epstein Barr Virus Remedy Epstein Barr Virus Remedy 30X LIQUID NOT APPLICABLE 20100319 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN HERPESVIRUS 4 30 [hp_X]/mL 57520-0170_37c9cbfa-2bec-43cf-a66b-4045c2f0fc91 57520-0170 HUMAN OTC DRUG Epstein Barr Virus Remedy Epstein-barr virus LIQUID ORAL 20100319 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN HERPESVIRUS 4 15 [hp_X]/mL 57520-0171_dce9b120-a707-4698-9937-f062f735ed89 57520-0171 HUMAN OTC DRUG Epstein Barr Virus Remedy Epstein Barr Virus Remedy 12X LIQUID NOT APPLICABLE 20100319 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN HERPESVIRUS 4 12 [hp_X]/mL 57520-0174_5d2481d6-62d3-4064-b1b5-e7c431e9f859 57520-0174 HUMAN OTC DRUG Epstein Barr Virus Remedy Spstein Barr Virus Remedy 6X LIQUID NOT APPLICABLE 20100318 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN HERPESVIRUS 4 6 [hp_X]/mL 57520-0175_2d02e16b-07b4-451d-b672-c85ed2a9d3a5 57520-0175 HUMAN OTC DRUG Virotox Echinacea angustifolia, Hydrastis canadensis, Lomatium, Myrrha, Nasturtium aquaticum, Tabebuia impetiginosa, Glandula suprarenalis, Thmus, LIQUID ORAL 20100903 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LOMATIUM; LYCOPODIUM CLAVATUM SPORE; MYRRH; RANCID BEEF; RORIPPA NASTURTIUM-AQUATICUM; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK 12; 3; 12; 3; 3; 12; 3; 200; 3; 12; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0176_b082f269-441e-438c-8323-2539f25301f9 57520-0176 HUMAN OTC DRUG Dr Wises Formula II Intestinal Calm Lycopodium clavatum, Pulsatilla, CAPSULE ORAL 20101028 UNAPPROVED HOMEOPATHIC Apotheca Company LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS 12; 12 [hp_X]/1; [hp_X]/1 57520-0177_06d2a31a-197f-45c4-b81e-1d72eece0c05 57520-0177 HUMAN OTC DRUG Happy Bones Urtica dioica, Calcarea hypophosphorosa, Mezereum, Natrum phosphoricum, Symphytum officinale, Calcarea phosphorica, Calcarea fluorica, Boron, Hekla lava, Vanadium metallicum, Silicea, Calcarea carboni LIQUID ORAL 20101025 UNAPPROVED HOMEOPATHIC Apotheca Company BORON; CALCIUM FLUORIDE; CALCIUM HYPOPHOSPHITE; COMFREY ROOT; DAPHNE MEZEREUM BARK; HEKLA LAVA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; SODIUM PHOSPHATE, DIBASIC ANHYDROUS; TRIBASIC CALCIUM PHOSPHATE; URTICA DIOICA; VANADIUM 12; 30; 6; 30; 6; 12; 30; 30; 6; 8; 4; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0178_5b42dc2f-1b21-4170-8238-d72eb9839a3b 57520-0178 HUMAN OTC DRUG Dr Wises Formula Intestinal Calm Lycopodium clavatum, Pulsatilla, CAPSULE ORAL 20101022 UNAPPROVED HOMEOPATHIC Apotheca Company LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS 12; 12 [hp_X]/1; [hp_X]/1 57520-0179_acedc885-0e35-42e7-b466-2a5b177604ab 57520-0179 HUMAN OTC DRUG Bac HP Apis mellifica, Arsenicum album, Belladonna, Chamomilla, Echinacea, Lachesis mutus, Mercurius Solubilis, LIQUID ORAL 20100915 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CHAMOMILE; ECHINACEA; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0181_6c6c255d-ec9c-4376-bc7e-5758004170cf 57520-0181 HUMAN OTC DRUG HCG Formula Foeniculum vulgare, Fucus vesiculosus, Lecithin, Ammonium carbonicum, Caulophyllum thalictroides, Galium aparine, Lac defloratum, Phosphorus, Phytolacca decandra, Rubus idaeus, Abrotanum, SPRAY ORAL 20101230 UNAPPROVED HOMEOPATHIC Apotheca Company AMMONIUM BROMIDE; AMMONIUM CARBONATE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CHLORIDE DIHYDRATE; CALCIUM ARSENATE; CAULOPHYLLUM THALICTROIDES ROOT; CLAVICEPS PURPUREA SCLEROTIUM; FENNEL SEED; FUCUS VESICULOSUS; GALIUM APARINE; HELLEBORUS NIGER ROOT; HUMAN CHORIONIC GONADOTROPIN; LECITHIN, SOYBEAN; LYCOPODIUM CLAVATUM SPORE; MANGANESE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; RUBUS IDAEUS LEAF; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SKIM MILK; STRYCHNOS IGNATII SEED; SUS SCROFA THYMUS; SUS SCROFA THYROID; TRIBASIC CALCIUM PHOSPHATE 8; 6; 8; 30; 30; 30; 8; 6; 30; 2; 3; 6; 30; 60; 3; 30; 8; 30; 30; 6; 6; 6; 30; 30; 6; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0182_ae784fde-ad2b-4330-9203-81c0cda21880 57520-0182 HUMAN OTC DRUG Extreme HCG Fucus vesiculosus, Cyanocobalamin, Glandula suprarenalis suis, Hepar suis, L-carnitine, Ornithine, Antimonium crudum, hCG, Throidinum, LIQUID ORAL 20101026 UNAPPROVED HOMEOPATHIC Apotheca Company ANTIMONY TRISULFIDE; CYANOCOBALAMIN; FUCUS VESICULOSUS; HUMAN CHORIONIC GONADOTROPIN; LEVOCARNITINE; ORNITHINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PANCRELIPASE; PORK LIVER; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA THYROID 8; 6; 2; 60; 30; 30; 12; 12; 6; 10; 6; 18; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0183_dd5c51b7-b8aa-49ec-a38c-14d09d98bcc6 57520-0183 HUMAN OTC DRUG Smart HCG Human chorionic gonadotropin, LIQUID ORAL 20101005 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN CHORIONIC GONADOTROPIN 60 [hp_X]/mL 57520-0186_6ffa93fa-d04c-4d10-8677-d00374e0558e 57520-0186 HUMAN OTC DRUG Bio Scleranthus Scleranthus, LIQUID ORAL 20100317 UNAPPROVED HOMEOPATHIC Apotheca Company SCLERANTHUS ANNUUS FLOWERING TOP 200 [hp_C]/mL 57520-0190_2cda9d1f-61be-45c8-acf1-87e0d436cfdd 57520-0190 HUMAN OTC DRUG StaLean L-carnitine tartrate, L-isoleucine, L-leucine, L-valine, Magnesia phosphorica, Pyridoxine, SPRAY ORAL 20100312 UNAPPROVED HOMEOPATHIC Apotheca Company DOPAMINE; ISOLEUCINE; LEUCINE; LEVOCARNITINE TARTRATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS; NERIUM OLEANDER LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PYRIDOXINE; SCHOENOCAULON OFFICINALE SEED; SEROTONIN; SILVER; SODIUM SULFATE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; VALINE 200; 60; 60; 60; 60; 200; 200; 200; 60; 200; 200; 200; 200; 100; 200; 200; 60 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 57520-0191_97f8d1d1-7719-4147-8b61-e4d2c7d5ee73 57520-0191 HUMAN OTC DRUG Liquid Detox Citrus limonum, Taraxacum officinale, Uva-ursi, Berberis vulgaris, Capsicum annuum, Galium aparine, Lobelia inflata, Nux vomica, Schisandra, Tylophora asthmatica, Brain, Cor, Glandula suprarenalis sui LIQUID ORAL 20100312 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CAPSICUM; GALIUM APARINE; LACTIC ACID, DL-; LEMON JUICE; LOBELIA INFLATA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PORK BRAIN; PORK HEART; PORK INTESTINE; PORK KIDNEY; PORK LIVER; SCHISANDRA CHINENSIS FRUIT; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA LUNG; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYROID; TARAXACUM OFFICINALE; TYLOPHORA INDICA ROOT 2; 3; 8; 3; 3; 8; 1; 3; 8; 8; 8; 8; 8; 8; 3; 3; 8; 8; 8; 8; 8; 2; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0197_e40940e8-b6c7-4e6b-a89a-41b198a5796e 57520-0197 HUMAN OTC DRUG Formula 4 Calendula officinalis, Bellis Perennis, Ledum Palustre, Arnica Montana, Phosphorus LIQUID ORAL 20100329 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; LEDUM PALUSTRE TWIG; PHOSPHORUS 30; 12; 6; 12; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0201_41b0cc6a-21e5-4be6-9dec-02aa6a6c5ce2 57520-0201 HUMAN OTC DRUG Formula 8 Arnica montana, Bellis perennis, Hypericum perforatum LIQUID ORAL 20100329 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 6; 6; 12; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0203_efb7e1df-1b3f-4acc-9769-553d433c344c 57520-0203 HUMAN OTC DRUG Formula 10 Arnica montana, Bellis perennis, Phosphorus, LIQUID ORAL 20100329 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BELLIS PERENNIS; DELPHINIUM STAPHISAGRIA SEED; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0204_f3f7373b-aecc-4529-a9fb-508f9409bddd 57520-0204 HUMAN OTC DRUG MBM 1 Bladder Irritated Berberis vulgaris, Bladder, Thuja occidentalis, Bryonia, Hepar sulphuris calcareum, LIQUID ORAL 20100426 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; BARIUM CARBONATE; BERBERIS VULGARIS FRUIT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; DELPHINIUM STAPHISAGRIA SEED; PULSATILLA VULGARIS; SUS SCROFA URINARY BLADDER; THUJA OCCIDENTALIS LEAFY TWIG 144; 144; 3; 89; 89; 89; 89; 3; 34 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0205_675906ae-4cf1-4a3e-92ac-230ca611b054 57520-0205 HUMAN OTC DRUG MBM 2 Gallbladder Fel tauri, Chionanthus virginica, Nux vomica, Arsenicum album, Platinum metallicum, LIQUID ORAL 20100422 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BOS TAURUS BILE; CHIONANTHUS VIRGINICUS BARK; PLATINUM; STRYCHNOS NUX-VOMICA SEED 233; 3; 34; 233; 34 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0206_d4df3d85-618d-46ec-9336-170b1e192b35 57520-0206 HUMAN OTC DRUG MBM 3 Heart Shock Phytolacca decandra, Spongia tosta, Crocus sativus, Coffea cruda, Aurum metallicum, LIQUID ORAL 20100420 UNAPPROVED HOMEOPATHIC Apotheca Company ARABICA COFFEE BEAN; GOLD; PHYTOLACCA AMERICANA ROOT; SAFFRON; SPONGIA OFFICINALIS SKELETON, ROASTED 89; 144; 3; 34; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0209_db719c57-f2a5-40a7-835e-97ef7f6d2c02 57520-0209 HUMAN OTC DRUG MBM 6 Liver Chelidonium majus, Liver, Cholesterinum, Lycopodium clavatum, Tarentula hispana, Arsenicum album, Belladonna, LIQUID ORAL 20100427 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ATROPA BELLADONNA; CHELIDONIUM MAJUS; CHOLESTEROL; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; PORK LIVER 233; 233; 3; 34; 144; 233; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0210_8beba2b1-0e6f-47b4-aa69-1bdff7e5be07 57520-0210 HUMAN OTC DRUG MBM 7 Lung Grief Coccus cacti, Lung, Ignatia amara, Causticum, Natrum muriaticum, LIQUID ORAL 20100426 UNAPPROVED HOMEOPATHIC Apotheca Company CAUSTICUM; PROTORTONIA CACTI; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; SUS SCROFA LUNG 233; 3; 233; 89; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0211_63aa6cef-c8ba-4dfb-a840-6c0f91b32b29 57520-0211 HUMAN OTC DRUG MBM Small Intestine Condurango, Intestine, Phytolacca decandra, Aconitum napellus, Aurum metallicum, Sulphur, LIQUID ORAL 20100503 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; GOLD; GOLDENSEAL; GRAPHITE; MARSDENIA CONDURANGO BARK; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; PORK INTESTINE; PULSATILLA VULGARIS; SULFUR; SULFUR 55; 55; 89; 233; 3; 144; 3; 3; 233; 55; 89 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0212_3e14e9d3-0c6a-422f-9784-5eac9220be8c 57520-0212 HUMAN OTC DRUG MBM 9 Spleen Pancreas Ceanothus americanus, Senna, Pancreas, Spleen, Chioanthus virginica, Cinchona officinalis, Sepia, LIQUID ORAL 20100422 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; CEANOTHUS AMERICANUS LEAF; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; SENNA LEAF; SEPIA OFFICINALIS JUICE; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN 233; 3; 34; 144; 233; 3; 144; 5; 5 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0213_bbde3db1-f78b-43a8-ae99-25063219ce35 57520-0213 HUMAN OTC DRUG MBM 10 Stomach Condurango, Stomach, Nux vomica, Aurum metallicum, Antimonium crudum, Hyoscyamus niger, Sulphur, LIQUID ORAL 20100422 UNAPPROVED HOMEOPATHIC Apotheca Company ANTIMONY TRISULFIDE; GOLD; HYOSCYAMUS NIGER; MARSDENIA CONDURANGO BARK; STRYCHNOS NUX-VOMICA SEED; SULFUR; SUS SCROFA STOMACH 233; 144; 233; 3; 89; 233; 5 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0214_8d385528-9ae6-4742-a18e-8217d672ecbf 57520-0214 HUMAN OTC DRUG MBM 11 Thyroid Adrenal Iodium, Phytolacca decandra, Adrenalinum, Adrenocorticotrophin, Thyroidinum, Belladonna, Phosphorus, Calcarea carbonica, Natrum muriaticum, Nux moschata, Stramonium, Argentum nitricum, LIQUID ORAL 20100422 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; CORTICOTROPIN; DATURA STRAMONIUM; EPINEPHRINE; IODINE; NUTMEG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SILVER NITRATE; SODIUM CHLORIDE; THYROID 34; 34; 89; 8; 3; 89; 89; 55; 3; 233; 89; 34 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0215_6ff9a84c-90f1-4ad0-86c8-32a69067b95d 57520-0215 HUMAN OTC DRUG MBM 12 Male Unresponsive Chimaphila umbellata, Pituitarinum gland, Uva-ursi, Orchitinum, Prostate, Sarsaparilla, LIQUID ORAL 20100709 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; CHIMAPHILA UMBELLATA; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SARSAPARILLA ROOT; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; SUS SCROFA TESTICLE; ZINC 5; 3; 34; 233; 144; 55; 3; 8; 8; 55 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0216_931cd89e-5ecf-4cee-adf5-f5c3d0931ab7 57520-0216 HUMAN OTC DRUG MBM 13 Female Phytolacca decandra, Pituitarinum gland, Scrophularia nodosa, Hypothalamus gland, Calcarea carbonica, Cimicifuga racemosa, LIQUID ORAL 20100504 UNAPPROVED HOMEOPATHIC Apotheca Company BLACK COHOSH; CAUSTICUM; GRAPHITE; LILIUM TIGRINUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM PHOSPHATE, DIBASIC; SCROPHULARIA NODOSA; SULFUR; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND 89; 144; 144; 89; 89; 3; 233; 3; 89; 5; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0217_10514191-5382-4ba8-9694-40ccf8e16760 57520-0217 HUMAN OTC DRUG Krebs Stimulator Plus Tabebuia impetiginosa, Uncaria tomentosa, Hypothalamus, Pituitary, Glandula suprarenalis, Nadidum, Lacticum acidum, LIQUID ORAL 20100325 UNAPPROVED HOMEOPATHIC Apotheca Company ADENOSINE TRIPHOSPHATE; BIS(CARBOXYETHYL)GERMANIUM SESQUIOXIDE; CAT'S CLAW; COENZYME A; LACTIC ACID, DL-; LACTIC ACID, L-; NADIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; TABEBUIA IMPETIGINOSA BARK; UBIDECARENONE 30; 8; 3; 30; 30; 30; 12; 60; 6; 200; 3; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0218_60e44ce6-90ad-4c8e-ac13-de404a08cb08 57520-0218 HUMAN OTC DRUG Allergy Composition Chondrus crispus, Glycyrrhiza glabra, Zingiber officinale, Amrposia artemisiaefolia, LIQUID ORAL 20100412 UNAPPROVED HOMEOPATHIC Apotheca Company AMBROSIA ARTEMISIIFOLIA; CHONDRUS; GINGER; GLYCYRRHIZA GLABRA; HISTAMINE DIHYDROCHLORIDE; IODINE; LEVODOPA; SCHOENOCAULON OFFICINALE SEED; SODIUM CARBONATE; TAURINE 6; 3; 3; 3; 4; 12; 6; 6; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0219_29d1a0b3-4c84-41f3-b1a9-63d645481f2e 57520-0219 HUMAN OTC DRUG Amoebasode Triticum aestivum, Cajuputum, Baptisia tinctoria, Capsicum annuum, Columbo, Fragaria vesca, Quassia amara, LIQUID ORAL 20100412 UNAPPROVED HOMEOPATHIC Apotheca Company AMOEBA PROTEUS; BAPTISIA TINCTORIA ROOT; BEEF LIVER; BOS TAURUS ADRENAL GLAND; CAJUPUT OIL; CAPSICUM; CINCHONA OFFICINALIS BARK; FRAGARIA VESCA FRUIT; GIARDIA LAMBLIA; JATEORHIZA CALUMBA ROOT; LYCOPODIUM CLAVATUM SPORE; QUASSIA AMARA WOOD; SENNA LEAF; SUS SCROFA SPLEEN; WHEAT; WORMWOOD 30; 3; 24; 30; 1; 3; 12; 3; 30; 3; 12; 3; 3; 24; 1; 6 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0220_de5f747c-5ac9-4ddc-aa30-88fd4f07390d 57520-0220 HUMAN OTC DRUG 1 Bladder Berberis vulgaris, Thuja occidentalis, Apis mellifica, Pulsatilla, Staphysagria, Baryta carbonica, Bryonia, Hepar sulphuris calcareum LIQUID ORAL 20100512 UNAPPROVED HOMEOPATHIC Apotheca, Company APIS MELLIFERA; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALCIUM SULFIDE; DELPHINIUM STAPHISAGRIA SEED; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG 200; 1; 3; 1; 1; 200; 200; 30 [hp_C]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_M]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0221_5027b20e-feb9-4c81-a791-ef42a3a52b2e 57520-0221 HUMAN OTC DRUG Nephroplex Berberis vulgaris, Hydrangea arborescens, Petroselinum sativum, Solidago virguarea, Uva-ursi, Rubia tinctorum. LIQUID ORAL 20100323 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; EUPATORIUM PURPUREUM ROOT; GLUTATHIONE; HYDRANGEA; MERCURIC CHLORIDE; PETROSELINUM CRISPUM; PORK KIDNEY; RUBIA TINCTORUM ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 3; 3; 12; 12; 6; 3; 12; 3; 6; 5; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0222_c249061a-1ec6-4329-b721-70d1af23c782 57520-0222 HUMAN OTC DRUG OB Metab Fucus vesiculosus, Capsicum annuum, Nicotinamidum, Spongia Tosta, Arginine, Croton oil, Ornithine Pituitary, Thyroidinum, Tyrosine, Calcarea carbonica, Graphites, Kali carbonicum LIQUID ORAL 20100330 UNAPPROVED HOMEOPATHIC Apotheca Company ARGININE; CHILI PEPPER; CROTON OIL; FUCUS VESICULOSUS; GRAPHITE; NIACINAMIDE; ORNITHINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITARY GLAND; THYROID; TYROSINE 6; 3; 6; 2; 12; 5; 6; 12; 12; 5; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0223_b969e9ff-3c48-494d-bf28-021e36ffcf76 57520-0223 HUMAN OTC DRUG Pure Oral hCG hCG, LIQUID ORAL 20100810 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN CHORIONIC GONADOTROPIN 200 [hp_C]/mL 57520-0224_ceb09115-7968-4595-bc80-787707e656a2 57520-0224 HUMAN OTC DRUG Melatonin Forte Niacin, Melatonin, Nadidum, Pyridoxinum hydrochloricum, Zincum sulphuricum, Hypothalamus, Lithium carbonicum, Magnesia carbonica, Pineal, Pituitary, SPRAY ORAL 20101007 20151108 UNAPPROVED HOMEOPATHIC Apotheca Company LITHIUM CARBONATE; MAGNESIUM CARBONATE; MELATONIN; NADIDE; NIACIN; PYRIDOXINE HYDROCHLORIDE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; ZINC SULFATE HEPTAHYDRATE 8; 8; 6; 6; 3; 6; 8; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0226_3a7c31f1-3553-4b1d-88fd-3afc53468ef0 57520-0226 HUMAN OTC DRUG Serotonin Serotonin LIQUID ORAL 20100721 UNAPPROVED HOMEOPATHIC Apotheca Company SEROTONIN 30 [hp_C]/mL 57520-0227_41ba4bee-2d70-41e1-936d-fa968335fe99 57520-0227 HUMAN OTC DRUG Systemic Detox Berberis vulgaris, Boldo, Chelidonium majus, Hydrastis canadensis, Lappa major, Taraxacum officinale, Trifolium pratense, LIQUID ORAL 20100720 UNAPPROVED HOMEOPATHIC Apotheca Company ALOE; ARCTIUM LAPPA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; ECHINACEA; GINKGO; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MARSDENIA CONDURANGO BARK; PEUMUS BOLDUS LEAF; SARSAPARILLA ROOT; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TABEBUIA IMPETIGINOSA BARK; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TRIFOLIUM PRATENSE POLLEN 30; 3; 3; 12; 3; 12; 30; 6; 3; 12; 6; 3; 12; 30; 30; 6; 3; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0228_5ec5cdae-59cf-4784-98d8-af0bd086d05f 57520-0228 HUMAN OTC DRUG Slim Lycopodium clavatum, Phytolacca decandra, Abies canadensis, Ammonium bromatum, Ammonium muriaticum, Pulsatilla, Kali bichromicum, Ammonium carbonicum, Fucus vesiculosus, LIQUID ORAL 20101001 UNAPPROVED HOMEOPATHIC Apotheca Company AMMONIUM BROMIDE; AMMONIUM CARBONATE; AMMONIUM CHLORIDE; ANTIMONY TRISULFIDE; BOS TAURUS ADRENAL GLAND; CALCIUM ARSENATE; CAPSICUM; FUCUS VESICULOSUS; GRAPHITE; IODINE; IRON; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SILVER NITRATE; SUS SCROFA THYROID; TSUGA CANADENSIS BARK 6; 6; 200; 4; 200; 200; 200; 200; 1; 4; 200; 3; 1; 3; 200; 200; 30; 4; 8; 30; 5; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 57520-0229_83d577ff-9b8d-4825-acd6-47158294b2f8 57520-0229 HUMAN OTC DRUG Pericardium Triple Warmer Meridian Opener Pericardium Triple Warmer Meridian Opener LIQUID ORAL 20100330 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BARIUM CARBONATE; GOLD; IODINE; LACHESIS MUTA VENOM; LITHIUM CARBONATE; LOBELIA INFLATA; MERCURIUS SOLUBILIS; NAJA NAJA VENOM; NITROGLYCERIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM IODIDE; SEPIA OFFICINALIS JUICE; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0231_3cb7a1c4-a44e-4f06-b80c-20e2632da6df 57520-0231 HUMAN OTC DRUG Headache Belladonna, Cimicifuga racemosa, Glonoinum, Lachesis mutus, Zingiber officinale, LIQUID ORAL 20100803 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; BLACK COHOSH; GINGER; LACHESIS MUTA VENOM; NITROGLYCERIN 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0232_d9a330cb-78c2-4b5b-bcea-08a14753713d 57520-0232 HUMAN OTC DRUG Cardioforce I Arnica montana, Cactus grandiflorus, Capsicum annuum, Spigelia anthelmia, Digitalis purpurea, Kali phosphoricum, Laurocerasus, Tabacum, LIQUID ORAL 20100402 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA; ARNICA MONTANA; CHILI PEPPER; DIGITALIS; GOLD TRICHLORIDE; KALMIA LATIFOLIA LEAF; LATRODECTUS MACTANS VENOM; NITROGLYCERIN; POTASSIUM PHOSPHATE, DIBASIC; PRUNUS LAUROCERASUS LEAF; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA; STRYCHNOS IGNATII SEED; TOBACCO LEAF; VALERIAN 12; 12; 3; 3; 6; 12; 12; 12; 12; 6; 6; 3; 3; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0233_7c6284ad-4bc0-4612-ae4b-33fdbc704437 57520-0233 HUMAN OTC DRUG Mammaryplex Echinacea angustifolia, Hydrastis canadensis, Myrrha, Phytolacca decandra, Trigonella foenum-graecum, Lymph, Spleen, Bryonia alba, Bufo rana, Conium maculatum, LIQUID ORAL 20101007 UNAPPROVED HOMEOPATHIC Apotheca Company BRYONIA ALBA ROOT; BUFO BUFO CUTANEOUS GLAND; CANIS LUPUS FAMILIARIS MILK; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; FENUGREEK SEED; GOLDENSEAL; LACHESIS MUTA VENOM; MYRRH; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; SUS SCROFA LYMPH; SUS SCROFA MAMMA; SUS SCROFA SPLEEN 12; 12; 12; 12; 3; 3; 3; 12; 3; 3; 12; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 57520-0234_25623427-1abb-437c-a673-bd9b2b7cd5f2 57520-0234 HUMAN OTC DRUG Thyrotox Chondrus crispus, Fucus vesiculosus, Thyroidinum, Belladonna, Calcarea carbonica, Conium maculatum, Iodium, Kali carbonicum. Phosphorus, Pulsatilla, Silicea, LIQUID ORAL 20101008 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; CHONDRUS CRISPUS; CONIUM MACULATUM FLOWERING TOP; FUCUS VESICULOSUS; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SUS SCROFA THYROID 12; 3; 12; 3; 12; 12; 12; 12; 12; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL 57520-0235_78099676-cf2f-45e5-8f9e-17627dc75978 57520-0235 HUMAN OTC DRUG Candida Alb Candida albicans LIQUID ORAL 20100617 UNAPPROVED HOMEOPATHIC Apotheca Company CANDIDA ALBICANS 30 [hp_X]/mL 57520-0236_bb18d011-7b72-4cc7-96e2-93d7c2e59630 57520-0236 HUMAN OTC DRUG Candida Alb Candida albicans LIQUID ORAL 20100402 UNAPPROVED HOMEOPATHIC Apotheca Company CANDIDA ALBICANS 100 [hp_X]/mL 57520-0237_4d2ad7c9-e83a-4c2c-8f38-cb039a169a24 57520-0237 HUMAN OTC DRUG Bio Vervain Vervain, LIQUID ORAL 20100402 UNAPPROVED HOMEOPATHIC Apotheca Company VERBENA 200 [hp_C]/mL 57520-0238_1ac987bd-7148-4f10-9dcf-ba8704a98fa7 57520-0238 HUMAN OTC DRUG Res Balancer Spleen, Thymus SPRAY ORAL 20100405 UNAPPROVED HOMEOPATHIC Apotheca Company SUS SCROFA SPLEEN; THYMUS 8; 8 [hp_X]/mL; [hp_X]/mL 57520-0239_ded4c506-15fe-4999-bc66-767b269e2c0a 57520-0239 HUMAN OTC DRUG 2 Gallbladder Fel tauri, Chionanthus virginica, Arsenicum album, Nux vomica, Platinum metallicum, LIQUID ORAL 20100802 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BOS TAURUS BILE; CHIONANTHUS VIRGINICUS BARK; PLATINUM; STRYCHNOS NUX-VOMICA SEED 1; 3; 30; 1; 1 [hp_M]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL 57520-0241_88a97dee-8ca0-45d6-87a5-ee7165e29104 57520-0241 HUMAN OTC DRUG Dr L Advanced HCG Formula Chromium GTF, Hypothalamus, HCG, Garcinia cambogia, LIQUID ORAL 20101028 UNAPPROVED HOMEOPATHIC Apotheca Company CHROMIUM PICOLINATE; HUMAN CHORIONIC GONADOTROPIN; HYDROXYCITRIC ACID; SUS SCROFA HYPOTHALAMUS 13; 34; 34; 13 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0242_232e7157-bf42-4334-a548-4f7a3ea95426 57520-0242 HUMAN OTC DRUG 4 Kidney Argentum nitricum, Arnica montana, Aconitum napellus, Nitricum acidum, Berberis vulgaris, Solidago virgaurea, LIQUID ORAL 20100820 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; NITRIC ACID; SILVER NITRATE; SOLIDAGO VIRGAUREA FLOWERING TOP 1; 1; 30; 1; 1; 30 [hp_M]/mL; [hp_M]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_C]/mL 57520-0243_5029a4cb-4017-47e6-af6e-e2d469e1fe72 57520-0243 HUMAN OTC DRUG 5 Large Intestine Hyddrastis canadensis, Senna, Agaricus muscarius, Arnica montana, Baptisia tinctoria, Cuprum metallicum, Nitricum acidum, LIQUID ORAL 20100802 UNAPPROVED HOMEOPATHIC Apotheca Company AMANITA MUSCARIA VAR. MUSCARIA; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; COPPER; GOLDENSEAL; NITRIC ACID; SENNA LEAF 1; 1; 1; 1; 3; 1; 3 [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL 57520-0244_b9f12fe9-e976-4335-b23d-9dc5aacc5c15 57520-0244 HUMAN OTC DRUG 6 Liver Chelidonium majus, Cholesterinum, Arsenicum album, Belladonna, Lycopodium clavatum, Tarentula hispana, LIQUID ORAL 20100921 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ATROPA BELLADONNA; CHELIDONIUM MAJUS; CHOLESTEROL; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA 1; 1; 3; 30; 1; 10 [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL 57520-0245_9a12fa87-6629-4079-8ffb-13799046eb0e 57520-0245 HUMAN OTC DRUG 7 Lung Causticum, Natrum muriaticum, Ignatia amara, Coccus cacti, LIQUID ORAL 20100810 UNAPPROVED HOMEOPATHIC Apotheca Company CAUSTICUM; PROTORTONIA CACTI; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 1; 3; 5; 600 [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL 57520-0246_5f8456fe-9207-4409-ba09-fb1384b57a17 57520-0246 HUMAN OTC DRUG 8 Small Intestine Condurango, Phytolacca decandra, Aconitum napellus, Aurum metallicum, Graphites, Hydrastis canadensis, Mercurius vivus, Sulphur, Pulsatilla, LIQUID ORAL 20100802 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; GOLD; GOLDENSEAL; GRAPHITE; MARSDENIA CONDURANGO BARK; MERCURY; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SULFUR 1; 1; 1; 1; 3; 1; 3; 10; 5 [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_M]/mL 57520-0248_546e2f66-74c5-4808-86c7-0b4adff97d22 57520-0248 HUMAN OTC DRUG 9 Spleen Pancreas Ceanothus americanus, Senna, Chionanthus virginica, Arsenicum album, Lycopodium clavatum, Sepia, LIQUID ORAL 20100802 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; CEANOTHUS AMERICANUS LEAF; CHIONANTHUS VIRGINICUS BARK; LYCOPODIUM CLAVATUM SPORE; SENNA LEAF; SEPIA OFFICINALIS JUICE 1; 3; 30; 1; 3; 1 [hp_M]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL 57520-0249_9805cbbb-63d8-475c-846b-0b59f9db0e84 57520-0249 HUMAN OTC DRUG 10 Stomach Condurango, Antimonium crudum, Aurum metallicum, Hyoscyamus niger, Nux vomica, Sulphur, LIQUID ORAL 20100803 UNAPPROVED HOMEOPATHIC Apotheca Company ANTIMONY TRISULFIDE; GOLD; HYOSCYAMUS NIGER; MARSDENIA CONDURANGO BARK; STRYCHNOS NUX-VOMICA SEED; SULFUR 1; 1; 1; 3; 1; 1 [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_M]/mL 57520-0250_e95de5c6-2642-4a08-9208-aae58e3801f2 57520-0250 HUMAN OTC DRUG Inflammation II Asafoetida, Kalmia latifolia, Causticum, Coldhicum autumnale, Ferrum metallicum, Gnaphalium polycephalum, Lithium benzoicum LIQUID ORAL 20100409 UNAPPROVED HOMEOPATHIC Apotheca Company ASAFETIDA; CAUSTICUM; COLCHICUM AUTUMNALE BULB; FILIPENDULA ULMARIA ROOT; IRON; KALMIA LATIFOLIA LEAF; LITHIUM BENZOATE; MERCURIC OXIDE, YELLOW; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF 8; 10; 10; 10; 10; 8; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0251_aa37ab13-8a75-4e6f-90bc-2a84a83901c4 57520-0251 HUMAN OTC DRUG 11 Thyroid Adrenal Iodium, Phytolacca decandra, Adrenalinum, Adrenocorticotrophin, Belladonna, Thyroidinum, Natrum muriaticum, LIPSTICK ORAL 20100803 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; CORTICOTROPIN; EPINEPHRINE; IODINE; NUTMEG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SILVER NITRATE; SODIUM CHLORIDE; THYROID 30; 6; 6; 3; 1; 1; 1; 3; 1; 200; 30 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_C]/mL; [hp_C]/mL 57520-0252_9519d3f4-4833-4aa2-b320-959e826ab3b9 57520-0252 HUMAN OTC DRUG 13 Female Phytolacca decandra, Scrophularia nodosa, Cimicifuga racemosa, Lilium tigrinum, Sulphur, Graphites, LIQUID ORAL 20100804 UNAPPROVED HOMEOPATHIC Apotheca Company BLACK COHOSH; CAUSTICUM; GRAPHITE; LILIUM TIGRINUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM PHOSPHATE, DIBASIC; SCROPHULARIA NODOSA; SULFUR 200; 1; 1; 1; 1; 3; 1; 3; 1 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL 57520-0254_c6e691fc-5ee3-483c-866d-dbe6af1bd2cd 57520-0254 HUMAN OTC DRUG Adrenapar Aralia quinquefolia, Avena sativa Glandula suprarenalis, Arsenicum iodatum, Ignatia amara, Lycopodium clavatum, Nux vomica, LIQUID ORAL 20101005 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; ARSENIC TRIIODIDE; AVENA SATIVA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; ZINC 3; 12; 3; 12; 12; 12; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0256_e67d500d-50aa-4be7-995d-7ae6def04a65 57520-0256 HUMAN OTC DRUG Phytolacca Phytolacca decandra LIQUID ORAL 20100504 20150520 UNAPPROVED HOMEOPATHIC Apotheca Company PHYTOLACCA AMERICANA ROOT 200 [hp_C]/mL 57520-0258_c3df9717-a817-41e6-b507-5cf3370a5857 57520-0258 HUMAN OTC DRUG Candida Alb Candida albicans LIQUID ORAL 20100331 UNAPPROVED HOMEOPATHIC Apotheca, Company CANDIDA ALBICANS 500 [hp_X]/mL 57520-0259_b4617c9e-15dd-4426-a993-de401d1626c5 57520-0259 HUMAN OTC DRUG Stress Mints Avena sativa, Agrimonia eupatoria, Aconitum napellus, Arnica montana, Ignatia amara, Chamomilla, Nux vomica, Pulsatilla, LOZENGE ORAL 20100930 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; AGRIMONIA EUPATORIA; ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; CHAMOMILE; PULSATILLA VULGARIS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED 12; 3; 12; 1; 30; 30; 12; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57520-0260_af163716-c8be-47b1-8c8e-e30df1b5b55f 57520-0260 HUMAN OTC DRUG Calm Drops Aconitum napellus, Arsenicum album, Calcarea carbonica, Chamomilla, Ignatia amara, Kali carbonicum, Lachesis mutus, Natrum muriaticum, Nux vomica, Phosphoricum acidum, Pulsatilla, Sepia, LOZENGE ORAL 20110415 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; CHAMOMILE; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED 6; 30; 12; 12; 30; 3; 30; 12; 30; 12; 30; 30 [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 57520-0261_145cfaa9-048f-4d51-8409-9700552ab4a2 57520-0261 HUMAN OTC DRUG Moon Drops Chamomilla, Coffea cruda, Arsenicum album, Ignatia amara, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Gelsemium sempervirens, Valeriana officinalis, LOZENGE ORAL 20101012 UNAPPROVED HOMEOPATHIC Apotheca Company ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; CHAMOMILE; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; VALERIAN 12; 30; 6; 12; 30; 30; 30; 30; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 57520-0262_5e7fe540-da3b-4422-b888-e30f4d42a8ba 57520-0262 HUMAN OTC DRUG Dentaforce Antimonium crudum, Belladonna, Calcarea carbonica, LIQUID ORAL 20100210 UNAPPROVED HOMEOPATHIC Apotheca Company ANTIMONY TRISULFIDE; ATROPA BELLADONNA; CALCIUM FLUORIDE; HEKLA LAVA; HYDROFLUORIC ACID; LEAD; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0263_13e17f95-8a0c-47be-952a-fbadeba088d4 57520-0263 HUMAN OTC DRUG Rhustoxoforce Apis mellifica, Cantharis, Graphites, Natrun muriaticum, Rhus glabra, Rhus toxicodendron, Thus venenata, Urtica dioica, LIQUID ORAL 20100401 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; GRAPHITE; LYTTA VESICATORIA; RHUS GLABRA TOP; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF; TOXICODENDRON VERNIX LEAFY TWIG; URTICA DIOICA 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0264_3d25ae5c-7c89-4687-9d18-7fb3ff59f32d 57520-0264 HUMAN OTC DRUG Taurine Taurine, LIQUID ORAL 20101025 UNAPPROVED HOMEOPATHIC Apotheca Company TAURINE 30 [hp_C]/mL 57520-0265_d03e1bc2-1ddf-46b1-a40e-7eb19e1440fb 57520-0265 HUMAN OTC DRUG Trauma Free Symphytum officinale, Bellis perennis, Hypericum perforatum,, Magnesia phosphorica, Ruta graveolens, Arnica montana, LIQUID ORAL 20100729 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BELLIS PERENNIS; COMFREY ROOT; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RUTA GRAVEOLENS FLOWERING TOP 200; 12; 3; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0266_b5925bc7-0841-4d6b-8a0b-738a08f3e04a 57520-0266 HUMAN OTC DRUG V HP Arsenicum album, Belladonna, Echinacea angustifolia, Eupatorium perfoliatum, Gelsemium sempervirens, Lycopodium clavatum, Phosphoricum acidum, Phosphorus, Pyrogenium, Rhus toxicodendron, LIQUID ORAL 20101026 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0268_de2c1c2f-6621-4027-97bd-f5ad10374f85 57520-0268 HUMAN OTC DRUG Injury Arnica montana, Calendula officinalis, Symphytum officinale, Hypericum perforatum, Belladonna, Bellis perennis, Carbo vegetabilis, LIQUID ORAL 20100813 UNAPPROVED HOMEOPATHIC Apotheca Company ACHILLEA MILLEFOLIUM; ACTIVATED CHARCOAL; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 12; 12; 3; 12; 12; 3; 3; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0271_96883a55-8231-4331-8a76-b92e824fef6e 57520-0271 HUMAN OTC DRUG Glutathione Glutathione, LIQUID ORAL 20100729 UNAPPROVED HOMEOPATHIC Apotheca Company GLUTATHIONE 6 [hp_X]/mL 57520-0272_e1b840f7-a357-448e-bef7-d4ed2b3a43c4 57520-0272 HUMAN OTC DRUG Fibro Relief Ferrum metallicum, Guaiacum, Lithium carbonicum, Lycopersicum esculentum, Magnesia phosphorica CAPSULE ORAL 20101217 UNAPPROVED HOMEOPATHIC Apotheca Company GUAIACUM OFFICINALE RESIN; IRON; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOMATO 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 57520-0273_76938ffd-dcec-4986-933d-680abeeecfcc 57520-0273 HUMAN OTC DRUG UR-IN-Control Belladonna, Apis mellifica, Argetnum nitricum, Cantharis, Equisetum arvense, Pulsatilla, Sarsaparilla, Terebinthina, Causticum, Petroselinum sativum, LIQUID ORAL 20101026 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ATROPA BELLADONNA; CAUSTICUM; EQUISETUM ARVENSE TOP; LYTTA VESICATORIA; PETROSELINUM CRISPUM; PULSATILLA VULGARIS; SARSAPARILLA ROOT; SILVER NITRATE; TURPENTINE 6; 4; 8; 6; 6; 8; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0283_d4c9f68b-0683-4de3-9507-bfb223d441b5 57520-0283 HUMAN OTC DRUG Candida Candida albicans LIQUID ORAL 20100408 UNAPPROVED HOMEOPATHIC Apotheca Company CANDIDA ALBICANS 200 [hp_C]/mL 57520-0284_63b42a73-6f1e-4dc2-ba8f-4b6167fa6d15 57520-0284 HUMAN OTC DRUG Candida-Ease Borax, Arsenicum album, Conium maculatum, Kreosotum, Lycopodium clavatum, Phosphorus, Pulsatilla, Sepia, Sulphur, LIQUID ORAL 20101102 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; CANDIDA TORRESII; CANDIDA TROPICALIS; CONIUM MACULATUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; MUCOR RACEMOSUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM BORATE; SULFUR; WOOD CREOSOTE 200; 200; 6; 6; 200; 200; 200; 200; 200; 200; 200; 200; 200; 3; 200; 200 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0285_e428ae4c-48c3-4058-b8f3-21b2756cb70f 57520-0285 HUMAN OTC DRUG Gallbladder Liver MO Arsenicum album, Berberis vulgaris, Bryonia alba, Calcarea carbonica, Carduus marianus, Cinchona officinalis, Kali Carbonicum, Lycopodium clavatum, Natrum sulphuricum, Nux vomica, Phosphorus, LIQUID ORAL 20100408 20150922 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0287_bd147e42-5527-41c3-b753-daa20755ebcd 57520-0287 HUMAN OTC DRUG Muscle Cramp and Spasm Relief Causticum, Colocynthis, Cuprum metallicum, Magnesia phosphorica, Phytolacca decandra, Rhus toxicodendron, Stannum metallicum, Veratrum album, TABLET ORAL 20101027 20151230 UNAPPROVED HOMEOPATHIC Apotheca Company CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; TIN; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57520-0288_16629aa4-0a24-4733-a6a5-fb88ed6aa918 57520-0288 HUMAN OTC DRUG Hypothalmus Tincture Aralia quinquefolia, Hydrocotyle asiatica, Polygonum multiflorum, Hypothalamus, Pituitarum posterium, Germanium sesquioxide, Pineal, LIQUID ORAL 20101028 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; CENTELLA ASIATICA; FALLOPIA MULTIFLORA ROOT; GERMANIUM SESQUIOXIDE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND 3; 3; 3; 12; 8; 14; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0289_15ffd03f-6140-4dfe-8db3-3202e0d539fe 57520-0289 HUMAN OTC DRUG Happy Happy Aurum metallicum, Lithium carbonicum, Serotonin, LIQUID ORAL 20100408 UNAPPROVED HOMEOPATHIC Apotheca Company GOLD; LITHIUM CARBONATE; SEROTONIN 30; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 57520-0290_766836d8-d3c3-405a-9070-85cfe95c204c 57520-0290 HUMAN OTC DRUG Viral Plus Arsenicum album, Belladonna, Echinacea, Eupatorium perfoliatum, Gelsemium sempervirens, Lycopodium clavatum, Phosphoricum acidum, Phosphorus, Pyrogenium, Rhus Toxicodendron, LIQUID ORAL 20101028 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0292_de56ee5e-a350-49b3-85ad-021b5fd4dc44 57520-0292 HUMAN OTC DRUG Sinusitis Sinusitis LIQUID ORAL 20100414 UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM SULFIDE; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILVER NITRATE; SINUSITISINUM; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA 10; 4; 6; 8; 12; 3; 2; 10; 12; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0293_73330513-c9ec-4f60-a575-80f0cc5504af 57520-0293 HUMAN OTC DRUG Spleen Spleen, SPRAY ORAL 20101028 UNAPPROVED HOMEOPATHIC Apotheca Company SUS SCROFA SPLEEN 6 [hp_X]/mL 57520-0294_6a3f6293-ea49-4eac-b9e8-03497b5e5cf1 57520-0294 HUMAN OTC DRUG Throat Formula Baptisia Tinctoria, Phytolacca decandra, Apis mellifica, Belladonna, Lachesis mutus, Mercurius solubilis, Hepar sulphuris calcareum, SPRAY ORAL 20101027 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT 12; 12; 3; 15; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0295_0a66ee3e-50b1-4069-bc31-3132b93669c8 57520-0295 HUMAN OTC DRUG Sinutone Echinacea, Hydrastis canadensis, Allium cepa, Ambrosia artemesiaefolia, Arsenicum album, Kali bichromicum, Nux moschata, Pulsatilla, Sepia, Solidago virgaurea, LIQUID ORAL 20101110 UNAPPROVED HOMEOPATHIC Apotheca Company AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; ECHINACEA; GOLDENSEAL; NUTMEG; ONION; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SOLIDAGO VIRGAUREA FLOWERING TOP 12; 12; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0297_dbd01e76-e98b-4814-9510-8113721d7434 57520-0297 HUMAN OTC DRUG Allerstat II Baptisia tinctoria, Echinacea, Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, LIQUID ORAL 20100412 UNAPPROVED HOMEOPATHIC Apotheca Company AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ECHINACEA; EUPHRASIA STRICTA; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0298_576bf341-ffa7-43c7-9486-302d970bb92c 57520-0298 HUMAN OTC DRUG Venoforce I Aesculus hippocastanum, Collinsonia canadensis, Echinacea angustifolia, Hamamelis virginiana, Pulsatilla, Arnica montana, Carbo vegetabilis, LIQUID ORAL 20100715 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; ARNICA MONTANA; COLLINSONIA CANADENSIS ROOT; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROFLUORIC ACID; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PAEONIA OFFICINALIS ROOT; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED 12; 12; 3; 3; 12; 3; 3; 12; 12; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0299_a4846c95-da72-406b-819f-165016a18ccb 57520-0299 HUMAN OTC DRUG Relaxoforce Humulus lupulus, Passiflora incarnata, Valeriana officinalis, Calcarea carbonica, Coffea tosta, Ignatia amara, Kali phosphoricum, Moschus, Nux vomica, Phosphorus, Pulsatilla, LIQUID ORAL 20100930 UNAPPROVED HOMEOPATHIC Apotheca Company COFFEE BEAN; HOPS; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA TOP; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; VALERIAN 12; 3; 12; 12; 3; 12; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0300_39cf5c1f-e3b5-443a-a4c4-da068c1d9ae0 57520-0300 HUMAN OTC DRUG Viscumforce Passiflora incarnata, Valeriana officinalis, Aurum metallicum, Bartya carbonica, Glonoinum, Phosphorus, Plumbum metallicum, Viscum album, LIQUID ORAL 20100929 UNAPPROVED HOMEOPATHIC Apotheca Company BARIUM CARBONATE; GOLD; LEAD; NITROGLYCERIN; PASSIFLORA INCARNATA TOP; PHOSPHORUS; VALERIAN; VISCUM ALBUM FRUITING TOP 12; 12; 12; 12; 3; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0301_d8728f43-6763-4920-a906-716b1d56622f 57520-0301 HUMAN OTC DRUG Progesterone Progesterone, LIQUID ORAL 20101008 UNAPPROVED HOMEOPATHIC Apotheca Company PROGESTERONE 30 [hp_C]/mL 57520-0302_e0cb67bb-dc44-4bb5-ad26-c1eec875ae1f 57520-0302 HUMAN OTC DRUG Serotonin Serotonin LIQUID ORAL 20101008 UNAPPROVED HOMEOPATHIC Apotheca Company SEROTONIN 30 [hp_C]/mL 57520-0303_c57ff82d-1dfd-454e-98fc-4f20fa4727e2 57520-0303 HUMAN OTC DRUG Renaforce Berberis vulgaris, Echinacea angustifolia, Coccus cacti, Kali muriaticum, Lycopodium clavatum, Nitricum acidum, LIQUID ORAL 20101102 UNAPPROVED HOMEOPATHIC Apotheca Company BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; POTASSIUM CHLORIDE; PROTORTONIA CACTI 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0304_3a7e9963-24ca-4102-be56-4995c1167071 57520-0304 HUMAN OTC DRUG Relaxatone Passiflora incarnata, Scutellaria lateriflora, Valeriana officinalis, Arsenicum album, Calcarea carbonica, Coffea cruda, Ignatia amara, Kali phosphoricum Lycopus virginicus, Staphysagria LIQUID ORAL 20101111 UNAPPROVED HOMEOPATHIC Apotheca Company ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; DELPHINIUM STAPHISAGRIA SEED; LYCOPUS VIRGINICUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA TOP; POTASSIUM PHOSPHATE, DIBASIC; SCUTELLARIA LATERIFLORA; STRYCHNOS IGNATII SEED; VALERIAN 12; 12; 12; 12; 12; 3; 12; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0305_d4903c91-e50f-493d-ad3f-0fd0cb4c2147 57520-0305 HUMAN OTC DRUG Headache HP Belladonna, Bryonia, Gelsemium sempervirens, Glonionum, Melilotus officinalis, Natrum muriaticum, Nitricum acidum, Nux vomica, Silicea Spigelia anthelmia LIQUID ORAL 20100412 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; MELILOTUS OFFICINALIS POLLEN; NITRIC ACID; NITROGLYCERIN; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0306_30ec071d-41d5-47a5-bdd0-18c3b7ccc95d 57520-0306 HUMAN OTC DRUG Tinnitus HP Ginkgo biloba, Chininum sulphuricum, Cinchona officinalis, Graphites, Natrum salicylicum, Plumbum metallicum, LIQUID ORAL 20100412 UNAPPROVED HOMEOPATHIC Apotheca Company ALLYLTHIOUREA; ASPIRIN; CINCHONA OFFICINALIS BARK; GINKGO; GRAPHITE; LEAD; QUININE SULFATE; SODIUM SALICYLATE; SPIGELIA 30; 30; 30; 6; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0307_407629b0-4a19-4eba-b1f0-3efdbf6ded73 57520-0307 HUMAN OTC DRUG Thyropar Fucus vesiculosus, Spongia tosta, Glandula suprarenalis LIQUID ORAL 20100413 UNAPPROVED HOMEOPATHIC Apotheca Company BROMINE; FUCUS VESICULOSUS; IODINE; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THYROID 12; 3; 12; 12; 12; 12; 3; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0308_aeda3c9c-17c8-43c0-a451-0d0c5bef4468 57520-0308 HUMAN OTC DRUG Candida Alb Candida albicans, LIQUID ORAL 20100716 UNAPPROVED HOMEOPATHIC Apotheca Company CANDIDA ALBICANS 12 [hp_X]/mL 57520-0309_1fb04c98-cf03-41e7-931a-885a2467fca3 57520-0309 HUMAN OTC DRUG Arnica Plus Arnica montana, Hamamelis virginiana, Rhus toxicodendron, GEL TOPICAL 20110315 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0310_6a532fad-5d7a-4fb2-be8d-7073377c0544 57520-0310 HUMAN OTC DRUG Recovatone Glycyrrhiza glabra, Kali muriaticum Magnesia muriatica, Tribulus terrestris, Zincum gluconicum, Kali phosphoricum, Natrum muriaticum, Iodium, Phosphorus, Adrenalinum, Adrenocorticotrophin, Ascorbicum LIQUID ORAL 20110802 UNAPPROVED HOMEOPATHIC Apotheca Company ARGININE; ASCORBIC ACID; BORON; CALCIUM GLUCONATE; CHROMIUM; COBALTOUS GLUCONATE; COPPER GLUCONATE; CORTICOTROPIN; CREATINE; EPINEPHRINE; FERROUS GLUCONATE; GLUTAMINE; GLYCYRRHIZA GLABRA; IODINE; LEUCINE; LEVOCARNITINE; MAGNESIUM CHLORIDE; MAGNESIUM GLUCONATE; MANGANESE GLUCONATE; MOLYBDENUM; NICKEL; ORNITHINE; PHOSPHORUS; POTASSIUM CHLORIDE; POTASSIUM GLUCONATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; SELENIUM DIOXIDE; SODIUM CHLORIDE; STRONTIUM CARBONATE; TRIBASIC CALCIUM PHOSPHATE; TRIBULUS TERRESTRIS FRUIT; VALINE; VANADIUM; ZINC GLUCONATE 6; 6; 12; 6; 8; 6; 6; 6; 6; 6; 6; 6; 1; 4; 6; 6; 2; 6; 6; 8; 8; 6; 5; 2; 6; 3; 8; 8; 3; 8; 9; 2; 6; 8; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0311_89716561-04ff-46b6-abe2-af32767bd50e 57520-0311 HUMAN OTC DRUG Joint Rescue Symphytum officinale, Capsicum annuum, Ledum palustre, Colchicum autumnale, Rhododendron chrysanthum, Ruta graveolens, GEL TOPICAL 20110311 UNAPPROVED HOMEOPATHIC Apotheca Company CAPSICUM; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 6; 12; 3; 6; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0313_8ae865b6-392b-4dad-a2a6-dd5e4728a35a 57520-0313 HUMAN OTC DRUG Tendon Rescue Bryonia, Ruta graveolens, Bellis perennis, Argentum metallicum, GEL TOPICAL 20110315 UNAPPROVED HOMEOPATHIC Apotheca Company BELLIS PERENNIS; BRYONIA ALBA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILVER 6; 12; 12; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0316_061c4e71-a247-4b61-81fa-44c63b60a338 57520-0316 HUMAN OTC DRUG Muscle Rescue Arnica montana, Rhus toxicodendron, Phytolacca decandra, Pulsatilla, Ruta graveolens, GEL TOPICAL 20110316 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 3; 12; 12; 12; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0318_6ff12212-9233-490c-b2d1-1eb843bc1b0c 57520-0318 HUMAN OTC DRUG Natural Progesterone Natural Progesterone SPRAY ORAL 20100415 UNAPPROVED HOMEOPATHIC Apotheca Company PROGESTERONE 8 [hp_X]/mL 57520-0319_2a882aa6-7e4d-4b90-876c-1c0268fcc2f1 57520-0319 HUMAN OTC DRUG Natural Testosterone Avena sativa, Epimedium, Lycopodium clavatum, Androstenedione, Damiana, Testosterone, Agnus castus, SPRAY ORAL 20100420 UNAPPROVED HOMEOPATHIC Apotheca Company ANDROSTENEDIONE; AVENA SATIVA FLOWERING TOP; CHASTE TREE; EPIMEDIUM GRANDIFLORUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; TURNERA DIFFUSA LEAFY TWIG 6; 3; 12; 3; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0320_dd0611da-b165-414e-bac5-e7a113e5f6bd 57520-0320 HUMAN OTC DRUG Calcium Composition Arnica montana, Echinacea, Boron Gluconate, Symphytum officinale, Hekla lava, Calcarea carbonica, Calcarea fluorica, LIQUID ORAL 20100426 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BORON GLUCONATE; CALCIUM FLUORIDE; COMFREY ROOT; ECHINACEA; HEKLA LAVA; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE 3; 12; 30; 30; 3; 30; 30; 30; 200; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0321_7744e663-bb51-49d0-8a5c-f770729bf8cc 57520-0321 HUMAN OTC DRUG Cerebral Composition Cholinum. Capsicum annuum, Ginkgo biloba, Arnica montana, Gelsemium sempervirens, Kali Phosphoricum, Anacardium orientale, Baryta Carbonica, Phosphorus, Serotonin, LIQUID ORAL 20100426 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BARIUM CARBONATE; CHILI PEPPER; CHOLINE HYDROXIDE; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; SEMECARPUS ANACARDIUM JUICE; SEROTONIN 6; 12; 3; 3; 6; 3; 12; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0322_4fed67f6-23fe-4bd9-8cba-e789a7a340c2 57520-0322 HUMAN OTC DRUG Colloidal Silver Colloidal silver, LIQUID ORAL 20100419 UNAPPROVED HOMEOPATHIC Apotheca Company SILVER 12 [hp_X]/mL 57520-0323_d05ba894-7dbf-4d2d-b0d6-cf41f645c6aa 57520-0323 HUMAN OTC DRUG Bowel Nosode B Faecalis Bowel Nosode B Faecalis LIQUID ORAL 20100512 UNAPPROVED HOMEOPATHIC Apotheca Company ALCALIGENES FAECALIS; SEPIA OFFICINALIS JUICE 30; 3 [hp_C]/mL; [hp_X]/mL 57520-0324_ac21ada6-dce8-4f35-a1f2-8d263c26b599 57520-0324 HUMAN OTC DRUG Lymph Detox Plus Apis mellifica, Arnica montana, Berberis vulgaris, Gelsemium sempervirens, Hydrastis canadensis, Phytolacca decandra, LIQUID ORAL 20100512 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; PHYTOLACCA AMERICANA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 6; 3; 3; 12; 3; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0326_dff7af9f-4395-4ae0-bfde-194f59f30edc 57520-0326 HUMAN OTC DRUG Stomaplex Carduus marianus, Gentiana lutea, Sambucus nigra LIQUID ORAL 20100427 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; ATROPINE SULFATE; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP; SENNA LEAF; SILYBUM MARIANUM SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA STOMACH 12; 12; 12; 3; 12; 12; 3; 3; 3; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0327_d314037f-af7d-4a49-a4ef-39e211f33ce0 57520-0327 HUMAN OTC DRUG Tobaccotox Avena sativa, Kali phosphoricum, Cactus grandiflorus, Daphne indica, Eucalyptol, Lobelia inflata, Mentholum, Ignatia amara, Nux vomica, Staphysagria, Tabacum, Benzinum, Naphtalinum, LIQUID ORAL 20100511 UNAPPROVED HOMEOPATHIC Apotheca Company AVENA SATIVA FLOWERING TOP; BENZENE; DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; EUCALYPTOL; LOBELIA INFLATA; MENTHOL; NAPHTHALENE; POTASSIUM PHOSPHATE, DIBASIC; SELENICEREUS GRANDIFLORUS STEM; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 1; 30; 3; 12; 3; 3; 3; 30; 2; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0328_1f31021c-e7ac-430e-9053-199631916b98 57520-0328 HUMAN OTC DRUG Thyroplex Fucus vesiculosus, Spongia tosta, Iodium, Liothyronine sodium, Pulsatilla, Glandula suprarenalis bovinum, LIQUID ORAL 20100511 UNAPPROVED HOMEOPATHIC Apotheca Company BOS TAURUS ADRENAL GLAND; FERROUS IODIDE; FUCUS VESICULOSUS; IODINE; LIOTHYRONINE SODIUM; LYCOPUS VIRGINICUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; POTASSIUM IODIDE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITARY GLAND; THYROID 8; 12; 3; 6; 6; 12; 12; 12; 12; 30; 3; 8; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0329_3dc12606-c5ba-4f4d-9937-862c3fd5a8a4 57520-0329 HUMAN OTC DRUG Edemaforce Cactus grandiflorus, Calendula officinalis, Convallaria majalis, Dulcamara, Leptandra virginica, Solidago virgaurea, Apis mellifica, Arnica montana, LIQUID ORAL 20100426 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; CONVALLARIA MAJALIS; CULVER'S ROOT; LEAD; LYCOPODIUM CLAVATUM SPORE; SAMBUCUS NIGRA FLOWERING TOP; SELENICEREUS GRANDIFLORUS STEM; SOLANUM DULCAMARA TOP; SOLIDAGO VIRGAUREA FLOWERING TOP 12; 12; 12; 12; 3; 12; 3; 3; 12; 12; 12; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0330_246e3d46-e52e-48a2-902b-ba90a91e34f6 57520-0330 HUMAN OTC DRUG Serotonin Seotonin LIQUID ORAL 20100511 UNAPPROVED HOMEOPATHIC Apotheca Company SEROTONIN 6 [hp_X]/mL 57520-0331_257046b7-f5de-491b-a8e8-bd57947d7bf9 57520-0331 HUMAN OTC DRUG Insomnia HP Arsenicum album, Coffea cruda, Kali carbonicum, Magnesia carbonica, Nux vomica, Passiflora incarnata, Sepia, Valeriana officinalis, LIQUID ORAL 20100426 UNAPPROVED HOMEOPATHIC Apotheca Company ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; MAGNESIUM CARBONATE; PASSIFLORA INCARNATA TOP; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0332_0d7a17cf-00fe-4d96-95aa-7b9748e290eb 57520-0332 HUMAN OTC DRUG Back and Neck Rescue Hypericum perforatum, Phytolacca decandra, Guaiacum, Ledum palustre, Conium maculatum, GEL TOPICAL 20110520 UNAPPROVED HOMEOPATHIC Apotheca Company CONIUM MACULATUM FLOWERING TOP; GUAIACUM OFFICINALE RESIN; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT 30; 6; 3; 6; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0333_fda75863-412b-4b6c-9d64-e184ecbd9290 57520-0333 HUMAN OTC DRUG HCG with Slimming Herbs Fucus vesiculosus, Cyanocobalamin, Glandula suprarenalis suis, Hepar suis, L-carnitine, Ornithine, Antimonium crudum, Human chorionic gonadotropin, LIQUID ORAL 20100913 UNAPPROVED HOMEOPATHIC Apotheca Company ANTIMONY TRISULFIDE; CYANOCOBALAMIN; FUCUS VESICULOSUS; HUMAN CHORIONIC GONADOTROPIN; LEVOCARNITINE; ORNITHINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PANCRELIPASE; PORK LIVER; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA THYROID 8; 6; 2; 60; 30; 30; 12; 12; 6; 10; 6; 18; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0334_507106fb-525c-4a3e-b773-3676889123e9 57520-0334 HUMAN OTC DRUG Joint Rescue Symphytum officinale, Capsicum annuum, Ledum palustre, Colchicum autumnale, Rhododendron chrysanthum, Ruta graveolens, GEL TOPICAL 20111012 UNAPPROVED HOMEOPATHIC Apotheca Company CAPSICUM; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 6; 12; 3; 6; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0336_f1e42df4-9106-4ba1-a695-c1e0970bda96 57520-0336 HUMAN OTC DRUG Muscle Ice Phytolacca deccandra, Symphytum officinale, Bellis perennis, Ledum palustre, Ruta graveolens, Magnesia phosphorica, Silicea, GEL TOPICAL 20110131 UNAPPROVED HOMEOPATHIC Apotheca Company BELLIS PERENNIS; COMFREY ROOT; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE 6; 3; 6; 9; 1; 6; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0337_ae27e487-5e54-4536-a981-a03d1bd447ff 57520-0337 HUMAN OTC DRUG Smart HCG Human chorionic gonadortopin, LIQUID ORAL 20101110 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN CHORIONIC GONADOTROPIN 60 [hp_X]/mL 57520-0340_831c05ad-762b-46ae-9ad1-6ea14ef64ccc 57520-0340 HUMAN OTC DRUG HCG Cord HCG (Human chorionic gonadotropin) LIQUID ORAL 20100430 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN CHORIONIC GONADOTROPIN 200 [hp_C]/mL 57520-0341_43c2aa9a-e1cd-41b9-bf7e-cc02880167a7 57520-0341 HUMAN OTC DRUG HCG Cord HCG (Human chorionic gonadotropin) SPRAY ORAL 20100429 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN CHORIONIC GONADOTROPIN 34 [hp_C]/mL 57520-0342_9da945c6-f8ee-4410-8106-fffb0c872d98 57520-0342 HUMAN OTC DRUG Norepinephrine Norepinephrine LIQUID ORAL 20100426 UNAPPROVED HOMEOPATHIC Apotheca Company NOREPINEPHRINE 30 [hp_C]/mL 57520-0343_559f2e7f-7372-4766-b130-f86d4701136d 57520-0343 HUMAN OTC DRUG Mold Mix Antigens Arsenicum album, Phosphorus, Pulsatilla, Sepia, Alternaria tenuis, Aspergillus niger, Rhizopus nigricans, LIQUID ORAL 20100511 UNAPPROVED HOMEOPATHIC Apotheca Company ALTERNARIA ALTERNATA; ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; PHOSPHORUS; PULSATILLA VULGARIS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE 200; 12; 200; 200; 200; 200; 200; 12; 12; 200; 200; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0345_164f2e8b-a58d-4fb7-8c14-f97a63f9ffd4 57520-0345 HUMAN OTC DRUG Sinuchron Arsenicum album, Hepar sulphuris calcareum, Hydrastis canadensis, Kali bichromicum, Lycopodium clavatum, Mercurius solubilis, Natrum muriaticum LIQUID ORAL 20100427 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; CALCIUM SULFIDE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; THUJA OCCIDENTALIS TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0346_5176bd87-c35a-43df-8e1f-33a7bcfa0775 57520-0346 HUMAN OTC DRUG Endopar M Aralia racemosa, Sabal serrulata, Glandula suprarenalis, Orchitinum, Pituitaria Glandula, Prostate, Agnus castus, LIQUID ORAL 20100504 UNAPPROVED HOMEOPATHIC Apotheca Company ARALIA RACEMOSA ROOT; CHASTE TREE; CLEMATIS RECTA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SAW PALMETTO; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; SUS SCROFA TESTICLE; THUJA OCCIDENTALIS LEAFY TWIG 3; 12; 12; 12; 12; 3; 6; 6; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0347_b9bd68a6-86f9-4e36-8981-b77627635d70 57520-0347 HUMAN OTC DRUG Bronchi HP Carbo vegetabilis, Cuprum metallicum, Drosera Rotundifolia LIQUID ORAL 20100504 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; CALCIUM SULFIDE; COPPER; DROSERA ROTUNDIFOLIA; IPECAC; LACHESIS MUTA VENOM; LOBELIA INFLATA; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0348_4cc5bae8-d9f5-43f6-ab2a-72a8d7caea0d 57520-0348 HUMAN OTC DRUG Thymupar Baptisia tinctoria, Echinacea, Hydrastis canadensis LIQUID ORAL 20100504 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; ECHINACEA; GOLDENSEAL; IRIDIUM; LACHESIS MUTA VENOM; THYMUS 12; 12; 3; 12; 3; 3; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0349_5e209dde-2290-48bd-b3a0-25726d3a89bb 57520-0349 HUMAN OTC DRUG Colosode Taraxacum officinale, Berberis vulgaris, Rhamnus purshiana, Rheum, Cina, Arsenicum album, Aloe socotrina, Colostrum, Gallbladder, Hepar bovinum, LIQUID ORAL 20100929 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; ALOE; ARANEUS DIADEMATUS; ARSENIC TRIOXIDE; ARTEMISIA CINA FLOWER; BEEF LIVER; BERBERIS VULGARIS ROOT BARK; BOTULINUM TOXIN TYPE A; CARBO ANIMALIS; CLOSTRIDIUM PERFRINGENS; COLOSTRUM HUMAN; ENTEROCOCCUS FAECALIS; ESCHERICHIA COLI; FRANGULA PURSHIANA BARK; GIARDIA LAMBLIA; INDOLE; LACTOBACILLUS ACIDOPHILUS; MANDRAGORA OFFICINARUM ROOT; MERCURIUS SOLUBILIS; PORK INTESTINE; PROTEUS MIRABILIS; PSEUDOMONAS AERUGINOSA; RHEUM OFFICINALE ROOT; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SELENIUM; SUS SCROFA GALLBLADDER; SUS SCROFA GALLBLADDER; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOT; YERSINIA ENTEROCOLITICA 30; 30; 12; 6; 12; 12; 3; 60; 12; 60; 8; 12; 32; 3; 200; 200; 15; 12; 12; 30; 60; 60; 3; 60; 12; 12; 12; 1; 12; 60 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0350_053cbe6f-b5f9-4b60-a683-fc24cf7285f3 57520-0350 HUMAN OTC DRUG Gold L-carnitine, L-glutamine, L-ornithine, L-tryptophan, L-tryosine, Human chorionic gonadotropin, LIQUID ORAL 20100930 UNAPPROVED HOMEOPATHIC Apotheca Company GLUTAMINE; HUMAN CHORIONIC GONADOTROPIN; LEVOCARNITINE; ORNITHINE; TRYPTOPHAN; TYROSINE 6; 60; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0351_d0bb8ac9-720d-4b67-9337-f507693656d5 57520-0351 HUMAN OTC DRUG Platinum For Women Cyanocobalamin, Glandula suprarenalis suis, Kali carbonicum, L-carnitine, L-glutamine, L-ornithine, L-tryptophan, L-tryosine, Oophorinum, LIQUID ORAL 20101001 UNAPPROVED HOMEOPATHIC Apotheca Company CYANOCOBALAMIN; GLUTAMINE; HUMAN CHORIONIC GONADOTROPIN; LEVOCARNITINE; ORNITHINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; SUS SCROFA THYROID; TRYPTOPHAN; TYROSINE 6; 6; 60; 6; 6; 12; 6; 6; 6; 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0352_348e14a2-cc38-4038-8c5a-82da9a3f6bcf 57520-0352 HUMAN OTC DRUG Lyme HP Baptisia tinctoria, Echinacea, Hydrastis canadensis, Arsenicum album, Bryonia, Chelidonium majus, Colchicum autumnale Kalmia latifolia, LIQUID ORAL 20100921 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BORRELIA BURGDORFERI; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; ECHINACEA; GOLDENSEAL; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 30; 3; 200; 30; 30; 30; 3; 3; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0353_96c50b73-d188-4152-9723-bf04e8cb2062 57520-0353 HUMAN OTC DRUG Psoriasis HP Arsenicum album, Borax, Graphites, Natrum muriaticum, Sepia, Sulphur, LIQUID ORAL 20101110 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; GRAPHITE; SEPIA OFFICINALIS JUICE; SODIUM BORATE; SODIUM CHLORIDE; SULFUR 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0355_da12de21-eba2-4347-baf2-d7a776759af8 57520-0355 HUMAN OTC DRUG Gastrotone Gentiana lutea, Sambucus nigra, Arsenicum album, Kali bichromicum, Lycopodium clavatum, Phosphorus, Pulsatilla Bismuthum carbonicum, LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BISMUTH SUBCARBONATE; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SAMBUCUS NIGRA FLOWERING TOP 12; 15; 3; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0356_f98cb631-685a-489b-ae97-225cda2e01e9 57520-0356 HUMAN OTC DRUG ADD HP Gamma-aminobutyric acid, L-dopa, Norepinephrine, Serotonin, Adrenocorticotropin, Anacardium orientale, Arsenicum album, Baryta carbonica, Calcarea carbonica, Calcarea phosphorica, Hyoscyamus niger, Ly LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Apotheca Company .GAMMA.-AMINOBUTYRIC ACID; ARSENIC TRIOXIDE; BARIUM CARBONATE; CORTICOTROPIN; DATURA STRAMONIUM; HYOSCYAMUS NIGER; LEVODOPA; LYCOPODIUM CLAVATUM SPORE; NOREPINEPHRINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEMECARPUS ANACARDIUM JUICE; SEROTONIN; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0357_9affe0a1-3f3a-4e5a-8256-2682ab3d63ab 57520-0357 HUMAN OTC DRUG Fungustat I Echinacea, Tabebuia impetiginosa, Abies nigra, Lycopodium clavatum, Nux vomica, Phosphorus, Pulsatilla, LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Apotheca Company CANDIDA ALBICANS; ECHINACEA; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PICEA MARIANA RESIN; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SKATOLE; STRYCHNOS NUX-VOMICA SEED; TABEBUIA IMPETIGINOSA BARK 30; 3; 12; 12; 12; 12; 12; 15; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0360_e34eafbf-81a9-438a-9425-230e98671e17 57520-0360 HUMAN OTC DRUG Anas Barbariae Anas Barbariae LIQUID ORAL 20100430 UNAPPROVED HOMEOPATHIC Apotheca Company CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/mL 57520-0362_57075482-7194-4ff6-b029-768bb3ff7948 57520-0362 HUMAN OTC DRUG Salmonella Salmonella LIQUID ORAL 20100503 UNAPPROVED HOMEOPATHIC Apotheca Company SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 30 [hp_X]/mL 57520-0363_a2b4738b-db33-4f58-80b6-e5fc163f3043 57520-0363 HUMAN OTC DRUG Tinnitus DX Calcarea carbonica, Carbo vegetabilis, Chininum sulphuricum, Cimicifuga racemosa, Cinchona officinalis, Coffea cruda, Graphites, Kali carbonicum, CAPSULE ORAL 20101112 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; ARABICA COFFEE BEAN; BLACK COHOSH; CINCHONA OFFICINALIS BARK; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; QUININE SULFATE; SALICYLIC ACID; SODIUM SALICYLATE 30; 12; 30; 30; 30; 30; 30; 30; 30; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57520-0364_373a0ca9-8490-405f-8d6c-a188c44751e4 57520-0364 HUMAN OTC DRUG Cherry Plum Cherry plum LIQUID ORAL 20100430 UNAPPROVED HOMEOPATHIC Apotheca Company PRUNUS CERASIFERA FLOWER 30 [hp_C]/mL 57520-0365_7794dfb9-effe-4609-b3bd-24c7ed16f527 57520-0365 HUMAN OTC DRUG Oak Oak, LIQUID ORAL 20100503 UNAPPROVED HOMEOPATHIC Apotheca Company QUERCUS ROBUR FLOWER 30 [hp_C]/mL 57520-0366_e03cff3f-c468-42aa-a5f7-76ab697bf2dc 57520-0366 HUMAN OTC DRUG Rock Water Rock water LIQUID ORAL 20100503 UNAPPROVED HOMEOPATHIC Apotheca Company WATER 30 [hp_C]/mL 57520-0367_90e83056-3284-4769-b2cd-6a7c4a4918ea 57520-0367 HUMAN OTC DRUG Ferrum Phos Ferrum phosphoricum LIQUID ORAL 20100503 UNAPPROVED HOMEOPATHIC Apotheca Company FERRUM PHOSPHORICUM 30 [hp_C]/mL 57520-0368_8689b716-9652-4f60-b0cf-41da342c6f17 57520-0368 HUMAN OTC DRUG Sepia Sepia LIQUID ORAL 20100503 UNAPPROVED HOMEOPATHIC Apotheca Company SEPIA OFFICINALIS JUICE 30 [hp_C]/mL 57520-0369_fbad7b62-a9b9-4495-94eb-4285e15c80c3 57520-0369 HUMAN OTC DRUG Thyroid Baryta carbonica, Calcarea carbonica, Calcarea iodata LIQUID ORAL 20100504 UNAPPROVED HOMEOPATHIC Apotheca Company BARIUM CARBONATE; CALCIUM IODIDE; FUCUS VESICULOSUS; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0370_9fc1f686-5f06-445b-9b62-9a76bac7598b 57520-0370 HUMAN OTC DRUG Liver Gallbladder Belladonna, Carduus marianus, Chelidonium majus, Colocynthis, Lycopodium clavatum, Natrum sulphuricum, Nux vomica, Phosphorus, Pulsatilla, Veratrum album LIQUID ORAL 20100430 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0371_dbf289ad-3ff4-458f-aeaa-57e6987590e0 57520-0371 HUMAN OTC DRUG Otoflam HP Belladonna , Conium maculatum, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali bichromicum, mercurius solubilis, Pulsatilla, Silicea, Chamonilla LIQUID ORAL 20100608 UNAPPROVED HOMEOPATHIC Apotheca, Company ATROPA BELLADONNA; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; FERRUM PHOSPHORICUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SOLANUM DULCAMARA TOP 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0372_06d4c68f-b5a8-4686-abe9-4e8b920929b4 57520-0372 HUMAN OTC DRUG L Dopa Phenolic L-dopa LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Apotheca Company LEVODOPA 30 [hp_C]/mL 57520-0373_ba24ceb4-e6ed-4c3e-a1fa-fd9de166d65a 57520-0373 HUMAN OTC DRUG Mold Antigens Arsenicum album, Phosphorus, Pulsatilla, Sepia, Alternaria tenuis, Aspergillus niger, Rhizopus nigricans, Mucor racemosus, Pullularia pullulans, Candida albicans, Candida parapsilosis, Torula cerevisi LIQUID ORAL 20100928 UNAPPROVED HOMEOPATHIC Apotheca Company ALTERNARIA ALTERNATA; ARSENIC TRIOXIDE; ASPERGILLUS NIGER VAR. NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; PHOSPHORUS; PULSATILLA VULGARIS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE RNA; SEPIA OFFICINALIS JUICE 200; 30; 200; 200; 200; 200; 200; 30; 30; 200; 200; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0374_6fc4776f-36a3-440f-9abf-8da18314477e 57520-0374 HUMAN OTC DRUG Anxiety Arsenicum album, Calcarea carbonica, Ignatia amara, Kali carbonicum, Lachesis mutus, Natrum muriaticum, Phosphorus, Pulsatilla, Staphysagria LIQUID ORAL 20100430 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; DELPHINIUM STAPHISAGRIA SEED; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0375_c0af72aa-bfd6-4e9e-b206-eee04b27fd1e 57520-0375 HUMAN OTC DRUG Bone Repair HP Calcarea carbonica, Calcarea Fluorica, Calcarea phosphorica, Hekla lava, Hydrofluoricum acidum, Magnesia phosphorica Rhus toxicodendron, Ruta graveolens, Silicea, Symphytum officinale LIQUID ORAL 20100430 UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM FLUORIDE; COMFREY ROOT; HEKLA LAVA; HYDROFLUORIC ACID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0376_db355a8f-887d-4206-89e9-fb9012d0be04 57520-0376 HUMAN OTC DRUG Cold Aconitum napellus, Allium cepa, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Kali bichromicum, Nercurius solubilis, Nux vomica, Pulsatilla LIQUID ORAL 20100430 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; MERCURIUS SOLUBILIS; ONION; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0377_ee09401b-0b40-493e-bb6e-6656842c1496 57520-0377 HUMAN OTC DRUG Allerpoll Allium cepa, Ambrosia artemisiaefolia, Apis mellifica LIQUID ORAL 20100504 UNAPPROVED HOMEOPATHIC Apotheca Company AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0378_732b1bcb-def6-4eb1-99d0-b2fb3bb6886d 57520-0378 HUMAN OTC DRUG Gaba Phenolic Gamma-aminobutyric acid LIQUID ORAL 20100503 UNAPPROVED HOMEOPATHIC Apotheca Company .GAMMA.-AMINOBUTYRIC ACID 30 [hp_C]/mL 57520-0381_06b15025-3a37-4268-8714-26ae933cf851 57520-0381 HUMAN OTC DRUG Pancreapar Hydrastis canadensis, Syzgium jambolanum, Glandula suprarenalis, Pancreas, Pituitaris glandula Phaseolus, LIQUID ORAL 20100507 UNAPPROVED HOMEOPATHIC Apotheca Company ACETIC ACID; GOLDENSEAL; KIDNEY BEAN; LACTIC ACID, DL-; PHOSPHORIC ACID; PHOSPHORUS; SUS SCROFA ADRENAL GLAND; SUS SCROFA PANCREAS; SUS SCROFA PITUITARY GLAND; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 12; 3; 9; 12; 12; 12; 6; 6; 6; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0382_e0719005-fdad-486f-bdba-13fc23fb6bfd 57520-0382 HUMAN OTC DRUG HCG Select Female Vitality Formula Fucus vesiculosus, Cyanocobalamin, Glandula suprarenalis suis, Hepar suis, Oophorinum, Human chorionic gonadotropin, LIQUID ORAL 20100901 UNAPPROVED HOMEOPATHIC Apotheca Company CYANOCOBALAMIN; FUCUS VESICULOSUS; GRAPHITE; HUMAN CHORIONIC GONADOTROPIN; PANCRELIPASE; PORK LIVER; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA THYROID; THUJA OCCIDENTALIS LEAFY TWIG 6; 2; 12; 60; 12; 6; 6; 18; 6; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0383_960ede38-d8a1-434f-9d81-00e3d1718cf8 57520-0383 HUMAN OTC DRUG Passion Drops Agnus castus, Lachesis mutus, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Phosphoricum acidum, Phosphorus, Pulsatilla, Sepia, LOZENGE ORAL 20110415 UNAPPROVED HOMEOPATHIC Apotheca Company CHASTE TREE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 9; 9; 9; 9; 9; 9; 9; 9; 9 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 57520-0384_c54bb312-aa8b-4e6e-9d15-4b620db78a6f 57520-0384 HUMAN OTC DRUG Bio Star of Bethlehem Star of bethlehem, LIQUID ORAL 20101111 UNAPPROVED HOMEOPATHIC Apotheca Company ORNITHOGALUM UMBELLATUM 200 [hp_C]/mL 57520-0385_a0a168d2-adb3-4de7-9f40-d9bfa591214f 57520-0385 HUMAN OTC DRUG Relax Histaminum hydrochloricum, Dopamine, Kidney, L-theanine, Penylethylamine hydrochloricum, SPRAY ORAL 20101230 UNAPPROVED HOMEOPATHIC Apotheca Company DOPAMINE; HISTAMINE DIHYDROCHLORIDE; PHENETHYLAMINE HYDROCHLORIDE; PORK KIDNEY; THEANINE 12; 6; 24; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0386_9cc82786-d11e-4404-b80c-50ffecbee270 57520-0386 HUMAN OTC DRUG Emotional Balance Rauwolfia serpentina, SPRAY ORAL 20101230 UNAPPROVED HOMEOPATHIC Apotheca Company RAUWOLFIA SERPENTINA 24 [hp_C]/mL 57520-0387_8037ebe4-249d-4d7a-b19d-9706bed2650b 57520-0387 HUMAN OTC DRUG hCG Detox Human chorionic gonadotropin (hCG), LIQUID ORAL 20101210 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN CHORIONIC GONADOTROPIN 60 [hp_X]/mL 57520-0388_e21b31df-a2fc-4040-8d05-e6f8d189769c 57520-0388 HUMAN OTC DRUG Arnica Drops Arnica montana, LOZENGE ORAL 20110415 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA 30 [hp_X]/1 57520-0389_8930fb91-6a13-4f83-bf11-51ce9737958a 57520-0389 HUMAN OTC DRUG Ligatone Arnica montana, Bryonia alba, Causticum, Calcarea phosphorica, Kali carbonicum, Manganese gluconate, Mezereum, Rhus toxidocendron, LIQUID ORAL 20100729 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; DAPHNE MEZEREUM BARK; MANGANESE GLUCONATE; POTASSIUM CARBONATE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SUS SCROFA TENDON; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE 12; 12; 12; 12; 12; 12; 12; 12; 8; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 57520-0390_a29600c8-b806-4f51-b664-da8b49f7e91a 57520-0390 HUMAN OTC DRUG Night Shade Antigen Chili pepper, Green pepper, Potato, Tobacco, Tomato, Eggplant, Nux vomica, Pulsatilla, LIQUID ORAL 20100804 UNAPPROVED HOMEOPATHIC Apotheca Company ALUMINUM; ARSENIC TRIOXIDE; CAPSICUM; EGGPLANT; GREEN BELL PEPPER; PHOSPHORUS; POTATO; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; TOMATO 12; 12; 30; 30; 30; 12; 30; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0391_08268a0b-dc44-4ba0-abbf-e73af0f80de6 57520-0391 HUMAN OTC DRUG Muscle Matrix Arginine, L-carnitine, Ornithine, LIQUID ORAL 20101209 UNAPPROVED HOMEOPATHIC Apotheca Company ARGININE; LEVOCARNITINE; ORNITHINE 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0392_cf76db10-20e5-4a5f-805f-faf52daa2dd5 57520-0392 HUMAN OTC DRUG Arnica Plus Arnia montana, Hamamelis virginiana, Rhus toxicodendron, GEL TOPICAL 20110308 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0393_32b9ad34-c7f2-4f30-b2f2-29f3e1b2647e 57520-0393 HUMAN OTC DRUG Back and Neck Rescue Hypericum perforatum, Phytolacca decandra, Guaiacum, Ledum palustre, Conium maculatum, GEL TOPICAL 20110307 UNAPPROVED HOMEOPATHIC Apotheca Company CONIUM MACULATUM FLOWERING TOP; GUAIACUM OFFICINALE RESIN; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT 30; 6; 3; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0394_230817dc-8771-4a34-a531-42ea0f91e899 57520-0394 HUMAN OTC DRUG Joint Rescue Symphytum officinale, Capsicum annuum, Ledum palustre, Colchicum autumnale, Rhododendron chrysanthum, Ruta graveolens, GEL TOPICAL 20110308 UNAPPROVED HOMEOPATHIC Apotheca Company CAPSICUM; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 6; 12; 3; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0395_3ddf4db9-92ee-4691-8eda-3453ac23049e 57520-0395 HUMAN OTC DRUG Muscle Ice Phytolacca decandra, Symphytum officinale, Bellis perennis, Ledum palustre, Ruta graveolens, Magnesia phosphorica, Silicea, GEL TOPICAL 20110311 UNAPPROVED HOMEOPATHIC Apotheca Company BELLIS PERENNIS; COMFREY ROOT; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE 6; 3; 6; 9; 1; 6; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0396_528b4ced-69f9-4c42-a257-dc4a0a0e01df 57520-0396 HUMAN OTC DRUG Muscle Rescue Arnica montana, Rhus Toxicodendron, Phytolacca decandra, Pulsatilla, Ruta graveolens, GEL TOPICAL 20110520 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 3; 12; 12; 12; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0398_c3e70690-16e5-4dad-8f29-16b6a6f82e81 57520-0398 HUMAN OTC DRUG Zyvestra Cocculus indicus, Ferrum metallicum, Gelsemium sempervirens, Phytolacca decandra, Pulsatilla, Silicea, TABLET ORAL 20101203 UNAPPROVED HOMEOPATHIC Apotheca Company ANAMIRTA COCCULUS SEED; GELSEMIUM SEMPERVIRENS ROOT; IRON; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE 55; 55; 55; 55; 55 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57520-0399_439c006f-c5d3-4143-b611-ec6e719ca0e4 57520-0399 HUMAN OTC DRUG Tendon Rescue Bryonia, Ruta graveolens, Bellis perennis, Argentum metallicum, GEL TOPICAL 20110224 UNAPPROVED HOMEOPATHIC Apotheca Company BELLIS PERENNIS; BRYONIA ALBA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILVER 6; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0401_5a5d4db8-421a-4837-aedd-920257b2754b 57520-0401 HUMAN OTC DRUG Acetylcholine Chloride Phenolic Acetylcholine chloride, LIQUID ORAL 20100507 UNAPPROVED HOMEOPATHIC Apotheca Company ACETYLCHOLINE CHLORIDE 30 [hp_C]/mL 57520-0402_264ff3cb-5231-4cc2-96bf-0ed4f1f2e152 57520-0402 HUMAN OTC DRUG Nausea Vomiting HP Aethusa cynapium, Arsenicum album, Cocculus indicus, Ipecacuanha, Kreosotum, Petroleum, Pulsatilla, Sanguinaria canadensis, Tabacum, LIQUID ORAL 20100507 UNAPPROVED HOMEOPATHIC Apotheca Company AETHUSA CYNAPIUM; ANAMIRTA COCCULUS SEED; ARSENIC TRIOXIDE; IPECAC; KEROSENE; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; TOBACCO LEAF; WOOD CREOSOTE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0403_f8ef92e3-30a6-41a1-a67f-11c41bd765d9 57520-0403 HUMAN OTC DRUG Quercetin Phenolic Quercetin, LIQUID ORAL 20100510 UNAPPROVED HOMEOPATHIC Apotheca Company QUERCETIN 30 [hp_C]/mL 57520-0404_eb3d9ff6-7f4c-4068-aabe-406e6ced5ffa 57520-0404 HUMAN OTC DRUG Progesterone Phenolic Progesterone, LIQUID ORAL 20100510 UNAPPROVED HOMEOPATHIC Apotheca Company PROGESTERONE 30 [hp_C]/mL 57520-0405_557342b8-9ec9-49d5-9565-3466c0e697bd 57520-0405 HUMAN OTC DRUG Artalgia Carduus marianus, Arnica montana, Agaricus muscarius, Baryta carbonica, Bellis perennis, Glonoinum, Hamamelis virginiana, Mercurius solubilis, Plumbum metallicum, Secale cornutum, Vanadium metallicum, LIQUID ORAL 20100506 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; AMANITA MUSCARIA VAR. MUSCARIA; ARNICA MONTANA; ARNICA MONTANA; BARIUM CARBONATE; BELLIS PERENNIS; CLAVICEPS PURPUREA SCLEROTIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEAD; MERCURIUS SOLUBILIS; NITROGLYCERIN; PHOSPHORUS; PULSATILLA VULGARIS; SILYBUM MARIANUM SEED; TOXICODENDRON PUBESCENS LEAF; VANADIUM 30; 12; 12; 3; 12; 12; 12; 12; 30; 12; 12; 12; 30; 30; 3; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0406_e27b57de-957d-4b21-82a5-6b5a45232669 57520-0406 HUMAN OTC DRUG Star of Bethlehem Star-of-Bethlehem LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC Apotheca Company ORNITHOGALUM UMBELLATUM 30 [hp_C]/mL 57520-0407_384a3edd-b7ce-4337-b930-5cfb2a94e72b 57520-0407 HUMAN OTC DRUG PMS Tone Angelica archangelica, Cimicifuga racemosa, LIQUID ORAL 20100517 UNAPPROVED HOMEOPATHIC Apotheca Company ANGELICA ARCHANGELICA ROOT; BLACK COHOSH; CANIS LUPUS FAMILIARIS MILK; COPPER; FUCUS VESICULOSUS; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE 3; 3; 12; 12; 3; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0409_fc0ff145-1ec5-409e-babf-7fdd080e6dbc 57520-0409 HUMAN OTC DRUG Anxiety Aconitum napellus, Arsenicum album, Belladonna, Calcarea carbonica, Carcinosin, Causticum, Gelsemium sempervirens, Lachesis mutus, SPRAY ORAL 20100909 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CAUSTICUM; GELSEMIUM SEMPERVIRENS ROOT; HUMAN BREAST TUMOR CELL; HUMAN BREAST TUMOR CELL; LACHESIS MUTA VENOM; MERCURY; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0410_c3309fcb-e48c-4357-a781-9439c6f20d1d 57520-0410 HUMAN OTC DRUG Thyrostat Fucus vesiculosus, Spongia tosta, Pituitaria glandula, Thyroidinum, Arsenicum iodatum, LIQUID ORAL 20100517 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIIODIDE; BARIUM CARBONATE; FUCUS VESICULOSUS; IODINE; LYCOPUS VIRGINICUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITARY GLAND; THYROID 12; 12; 3; 12; 12; 12; 12; 3; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0411_80aeca4f-f7b8-427f-8bf2-75f6a9fe800f 57520-0411 HUMAN OTC DRUG Bronchitone Echinacea, Lobelia inflata, Antimonium tartaricum, Aralia racemosa, Drosera, Ipecacuanha, Kali Carbonicum, Phosphorus, Spongia tosta LIQUID ORAL 20100517 UNAPPROVED HOMEOPATHIC Apotheca Company ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; DROSERA ROTUNDIFOLIA; ECHINACEA; IPECAC; LOBELIA INFLATA; PHOSPHORUS; POTASSIUM CARBONATE; SPONGIA OFFICINALIS SKELETON, ROASTED 12; 12; 12; 3; 12; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0412_259286e6-d7e0-49c3-8027-c12f3b492cc7 57520-0412 HUMAN OTC DRUG HZ HP Lycopodium clavatum, Mezereum, Natrum acidum, Ranunculus bulbosus, Rhus Toxicodendron, Sepia, Thuja occidentalis LIQUID ORAL 20100517 UNAPPROVED HOMEOPATHIC Apotheca Company DAPHNE MEZEREUM BARK; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; THUJA OCCIDENTALIS TWIG; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0413_bf47ad4a-c1a8-4ff8-a1f7-5ff5308c5018 57520-0413 HUMAN OTC DRUG Hepapar Carduus marianus, Chelidonium majus, Taraxacum officinale LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC Apotheca Company CHELIDONIUM MAJUS; CHENOPODIUM AMBROSIOIDES; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHOSPHORUS; PORK LIVER; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 3; 6; 12; 12; 12; 6; 3; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0414_89486a2b-24b3-4439-83de-9df84c0a312c 57520-0414 HUMAN OTC DRUG ALZ HP Anacardium orientale, Belladonna, Hyoscyamus LIQUID ORAL 20100625 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; BARIUM CARBONATE; DATURA STRAMONIUM; HYOSCYAMUS NIGER; LACHESIS MUTA VENOM; PHOSPHORUS; POTASSIUM BROMIDE; SEMECARPUS ANACARDIUM JUICE; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0415_a7f7f45f-7ebd-4634-bbf8-ec5a50dbbd04 57520-0415 HUMAN OTC DRUG Gastropanpar Pancreas, Stomach, Arsenicum album, Graphites, Lycopodium clavatum, Nux vomica, Phosphorus, Syzygium jambolanum, LIQUID ORAL 20100528 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; SYZYGIUM CUMINI SEED 12; 12; 12; 12; 12; 30; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0416_163628d9-5349-44ed-9890-c8d0df625d66 57520-0416 HUMAN OTC DRUG Asthma HP Arsenicum album, Belladonna, Blatta orientalis, Ipecacuanha, Kali carbonicum, Lobelia inflata, Natrum sulphuricum, Silicea LIQUID ORAL 20100517 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLATTA ORIENTALIS; IPECAC; LOBELIA INFLATA; POTASSIUM CARBONATE; SILICON DIOXIDE; SODIUM SULFATE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0417_30ba16dc-4dc2-4568-8d4b-028f846e2e99 57520-0417 HUMAN OTC DRUG Cystotone Sarsaparilla, Uva-ursi, Arsenicum album, Cantharis, Pareira brava, Pulsatilla, Sepia, Terebinthina, Populus tremuloides LIQUID ORAL 20100517 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; ARSENIC TRIOXIDE; CHONDRODENDRON TOMENTOSUM ROOT; LYTTA VESICATORIA; POPULUS TREMULOIDES LEAF; PULSATILLA VULGARIS; SARSAPARILLA; SEPIA OFFICINALIS JUICE; TURPENTINE 3; 12; 12; 12; 15; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0418_9da142fc-8c52-4410-8cfd-b496ebe3a11d 57520-0418 HUMAN OTC DRUG Allerstat I Chelidonium majus, Echinacea, Gentiana lutea, Arsenicum album, Carbo vegetabilis, Lycopodium clavatum, Nux vomica, Phosphorus, Pulsatilla LIQUID ORAL 20100517 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; CHELIDONIUM MAJUS; ECHINACEA; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED 12; 12; 3; 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0419_439dfa56-a1e1-48d8-88d1-80491d221d7c 57520-0419 HUMAN OTC DRUG Musco MXT Eleuthero, Epiphegus virginiana, Lacticum acidum, Tecoma pentaphylla, Hydrocotyle asiatica, Hydrocyanicum acidum, LIQUID ORAL 20100614 UNAPPROVED HOMEOPATHIC Apotheca Company CENTELLA ASIATICA; ELEUTHERO; EPIFAGUS VIRGINIANA; HYDROGEN CYANIDE; LACTIC ACID, DL-; TABEBUIA HETEROPHYLLA BARK 100; 15; 15; 100; 15; 15 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0421_fe56a0e4-7fea-4f91-83be-dd1a6d6c3b5e 57520-0421 HUMAN OTC DRUG Rehydrate Avena sativa, Equisetum hyemale, Hypericum perforatum, Ulmus fulva, Glycyrrha glabra, Pueraria lobata, LIQUID ORAL 20100614 UNAPPROVED HOMEOPATHIC Apotheca Company ADENOSINE TRIPHOSPHATE; AVENA SATIVA FLOWERING TOP; EQUISETUM HYEMALE; GERMANIUM SESQUIOXIDE; GLYCYRRHIZA GLABRA; HYDROGEN; HYPERICUM PERFORATUM; OXYGEN; PUERARIA MONTANA VAR. LOBATA ROOT; ULMUS RUBRA BARK; WATER 30; 3; 4; 30; 12; 30; 6; 30; 12; 6; 30 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 57520-0422_ab27b164-3e7c-4757-973d-a05f5d9b1e51 57520-0422 HUMAN OTC DRUG AsthmaClear Ambrosia artemisiaefolia, Antimonium tartaricum, Carbo vegetabilis, Ipecacuanha, Kali carbonicum, Lobelia inflata, Oxygenium, CAPSULE ORAL 20100602 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; AMBROSIA ARTEMISIIFOLIA; ANTIMONY POTASSIUM TARTRATE; IPECAC; LOBELIA INFLATA; OXYGEN; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SAMBUCUS NIGRA SUBSP. CANADENSIS FLOWERING TOP; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 57520-0423_f15a4fae-b01a-4016-8fe2-f99517e61ff5 57520-0423 HUMAN OTC DRUG Migraine Relief Belladonna, Bryonia, Cyclamen europaeum, Gelsemium sempervirens, Sanguianaria canadensis, Spigelia anthelmia CAPSULE ORAL 20101006 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; BRYONIA ALBA ROOT; CYCLAMEN PURPURASCENS TUBER; GELSEMIUM SEMPERVIRENS ROOT; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA 10; 10; 8; 6; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57520-0424_a434d123-4144-40a0-8914-0cdbf3eeea31 57520-0424 HUMAN OTC DRUG Restless Legs Relief Gnaphalium polycephalum, Viscum album, Aconitum napellus, Ledum palustre, Magnesia phosphorica, Rhus toxicodendron, TABLET ORAL 20101116 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP 6; 6; 6; 4; 6; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57520-0425_3b5b4bdf-9afa-4663-a9b4-492df3bf0ded 57520-0425 HUMAN OTC DRUG Type 3 Sinus Regular Silicea, Hydrastis canadensis, Kali bichromicum, Calcarea carbonica, TABLET ORAL 20100603 UNAPPROVED HOMEOPATHIC Apotheca Company GOLDENSEAL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; SILICON DIOXIDE 6; 12; 6; 2 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 57520-0426_0dafd9c3-c46a-4cbf-a713-3e2ea4d5875c 57520-0426 HUMAN OTC DRUG Type 3 Sinus Max Calcarea carbonica, Hydrastis canadensis, Kali bichromicum, Silicea, TABLET ORAL 20100714 UNAPPROVED HOMEOPATHIC Apotheca Company GOLDENSEAL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; SILICON DIOXIDE 200; 200; 200; 200 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg 57520-0427_8a97bdae-acc6-447c-88d6-d43b3a952e8d 57520-0427 HUMAN OTC DRUG Type 4 Noise Regular Causticum, Chininum sulphuricum, Cinchona officinalis, Pulsatilla, Thiosinaminum, TABLET ORAL 20100715 UNAPPROVED HOMEOPATHIC Apotheca Company ALLYLTHIOUREA; CAUSTICUM; CINCHONA OFFICINALIS BARK; PULSATILLA VULGARIS; QUININE SULFATE 6; 3; 6; 6; 3 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 57520-0428_3f06b0ee-59c2-4a90-a680-f863b12b40cb 57520-0428 HUMAN OTC DRUG Type 4 Noise Max Causticum, Chininum sulphuricum, Cinchona officinalis Pulsatilla, Thiosinaminum, TABLET ORAL 20100714 UNAPPROVED HOMEOPATHIC Apotheca Company ALLYLTHIOUREA; CAUSTICUM; CINCHONA OFFICINALIS BARK; PULSATILLA VULGARIS; QUININE SULFATE 200; 200; 200; 200; 200 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg 57520-0429_4c24e149-8f3e-498d-8139-5c2bc8c26ed2 57520-0429 HUMAN OTC DRUG Type 7 Stress Anxiety Regular Kali phosphoricum, Phosphoricum acidum, Sepia, Sulphus Calcarea carbonica, Silicea, TABLET ORAL 20100714 UNAPPROVED HOMEOPATHIC Apotheca Company OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR 12; 6; 3; 6; 12; 6 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 57520-0430_1c6dbf78-6b9e-48b8-826d-5a2ede6d652a 57520-0430 HUMAN OTC DRUG Type 7 Stress Anxiety Max Calcarea carbonica, Kali phosphoricum, Phosphoricum acidum, Sepia, Silicea, Sulphur, TABLET ORAL 20100715 UNAPPROVED HOMEOPATHIC Apotheca Company OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SEPIA OFFICINALIS JUICE; SULFUR 200; 200; 200; 200; 200 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg 57520-0431_a5500e1f-9d32-46c3-8f61-adfb785108ff 57520-0431 HUMAN OTC DRUG Type 11 Dizziness Regular Belladonna, Phosphorus, Pulsatilla, Calcarea carbonica, Silicea, TABLET ORAL 20100715 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE 6; 12; 6; 6; 12 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 57520-0432_58cf025e-cbd8-47e9-b5d6-3fa3e608d040 57520-0432 HUMAN OTC DRUG Type 11 Dizziness Max Belladonna, Calcarea carbonica, Phosphorus, Pulsatilla, Silicea, TABLET ORAL 20100715 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE 200; 200; 200; 200; 200 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg 57520-0434_65dbd6d0-d7d5-4ffb-ba2b-7a5b01673a1b 57520-0434 HUMAN OTC DRUG Hypothalmupar Aralia quinquefolia, Ginkgo biloba, Hydrocotyle asiatica LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; CENTELLA ASIATICA; GINKGO; PHOSPHORUS; PORK BRAIN; SILICON DIOXIDE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND 3; 3; 3; 12; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0435_206a8520-8253-41d5-9400-88ae5f0f13c1 57520-0435 HUMAN OTC DRUG Dentastat Allium sativum, Berberis vulgaris, Fucus vesiculosus, Phytolacca decandra, Argentum metallicum, Aurum metallicum, Calcarea fluorica, Calcarea phosphorica, Iodium, Mercurius solubilis, Niccolum metalli LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC Apotheca Company BERBERIS VULGARIS ROOT BARK; CALCIUM FLUORIDE; FUCUS VESICULOSUS; GARLIC; GOLD; IODINE; MERCURIUS SOLUBILIS; NICKEL; PHYTOLACCA AMERICANA ROOT; PLATINUM; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; ZINC 3; 12; 3; 3; 12; 12; 12; 12; 3; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0436_6b9689b3-182e-4007-a173-4fbb27fa8747 57520-0436 HUMAN OTC DRUG Diabenex HP Aceticum acidum, Colchicum autumnale, Lacticum acidum, Lycopodium clavatum, Phosphoricum acidum, Phosphorus, Syzgium jambolanum, Uranium nitricum LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC Apotheca Company ACETIC ACID; COLCHICUM AUTUMNALE BULB; LACTIC ACID, DL-; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0438_8097549e-729a-43dd-ad26-0edfbf299a55 57520-0438 HUMAN OTC DRUG Adrenapar Aralia quinquefolia, Avena sativa, Glandula suprarenalis LIQUID ORAL 20100525 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; ARSENIC TRIIODIDE; AVENA SATIVA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; ZINC 3; 12; 3; 12; 12; 12; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0439_32ef0907-e0bf-4161-8a91-f5784055b191 57520-0439 HUMAN OTC DRUG Bactestat Baptisia tinctoria, Echinacea, Phytolacca decandra, Aconitum napellus, Arsenicum album, Belladonna, Ferrum phosphoricum, Lachesis mutus, Phosphorus LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; ECHINACEA; FERRUM PHOSPHORICUM; LACHESIS MUTA VENOM; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT 12; 12; 12; 3; 3; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0440_f03a7c97-9d7d-4c7a-89b3-3be11f67cf4b 57520-0440 HUMAN OTC DRUG Arnica Arnica montana LIQUID ORAL 20100525 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA 3 [hp_X]/mL 57520-0441_3f57d9aa-65ad-4946-9225-8581f75c1367 57520-0441 HUMAN OTC DRUG Pancreaplex Chelidonium majus, Glycyrrhiza glabra, Hydrastis canadensis, Nux muschata LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC Apotheca Company BEEF LIVER; BOS TAURUS PANCREAS; CHELIDONIUM MAJUS; GINGER; GLYCYRRHIZA GLABRA; GOLDENSEAL; KIDNEY BEAN; NUTMEG; PHOSPHORIC ACID; PHOSPHORUS; RHEUM OFFICINALE ROOT; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SYZYGIUM CUMINI SEED; TARAXACUM OFFICINALE; THYROID 6; 6; 3; 3; 3; 3; 12; 3; 12; 12; 3; 6; 6; 3; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0442_382bf7fb-7d82-486d-8274-9b0006175ee1 57520-0442 HUMAN OTC DRUG Arrythmiaforce Convallaria majalis, Juglans nigra, Leonurus cardiaca, Adonis vernalis, Magnesia sulphurica, LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC Apotheca Company ADONIS VERNALIS; BLACK WALNUT LEAVES; CONVALLARIA MAJALIS; DIGITALIS; IBERIS AMARA SEED; LEONURUS CARDIACA; LYCOPUS VIRGINICUS; MAGNESIUM SULFATE HEPTAHYDRATE; PHOSPHORUS; POTASSIUM CHLORATE 4; 3; 3; 12; 6; 3; 12; 4; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0443_6c760728-d25e-4c5d-be1b-9f546f2ce729 57520-0443 HUMAN OTC DRUG Dopamine Dopamine LIQUID ORAL 20100520 UNAPPROVED HOMEOPATHIC Apotheca Company DOPAMINE 6 [hp_X]/mL 57520-0444_e231affd-35ad-4a5c-8a90-877289c30c4e 57520-0444 HUMAN OTC DRUG Tryptophan Tryptophan, LIQUID ORAL 20100603 UNAPPROVED HOMEOPATHIC Apotheca Company TRYPTOPHAN 30 [hp_C]/mL 57520-0445_34fa089d-8d0b-4891-9cd1-99c25eabb54d 57520-0445 HUMAN OTC DRUG Kidney Tonic I Echinacea angustifolia, Petroselinum sativum, Solidago vigraurea, Uva-ursi, Pareira brava, Gluthathione, Kidney, Cantharis, Lycopodium clavatum, LIQUID ORAL 20101008 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; CHONDRODENDRON TOMENTOSUM ROOT; ECHINACEA ANGUSTIFOLIA; GLUTATHIONE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PETROSELINUM CRISPUM; PORK KIDNEY; SOLIDAGO VIRGAUREA FLOWERING TOP 1; 3; 1; 6; 12; 12; 1; 200; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0447_066e4813-26ce-4a31-a515-96f240edc059 57520-0447 HUMAN OTC DRUG Menopause Angelica archangelica, Aralia quinquefolia, Cimicifuga racemosa, Hydrastis canadensis, Pulsatilla, Sabina, Sepia, Sulphuricum acidum, Lachesis mutus, LIQUID ORAL 20100520 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; ANGELICA ARCHANGELICA ROOT; BLACK COHOSH; GOLDENSEAL; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SAVIN; SEPIA OFFICINALIS JUICE; SULFURIC ACID 3; 3; 3; 3; 15; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0450_fcd3a5f2-afbd-4f7f-9c92-9a77a0de1e4d 57520-0450 HUMAN OTC DRUG Restless Legs Relief Aconitum napellus, Gnaphalium polycephalum, Ledum palustre, Magnesia phosphorica, Rhus Toxicodendron, Viscum album TABLET ORAL 20101111 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP 6; 6; 6; 4; 6; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57520-0451_bdc5679c-3006-4256-a527-f933447f0ea2 57520-0451 HUMAN OTC DRUG Bio Beech Beech LIQUID ORAL 20101123 UNAPPROVED HOMEOPATHIC Apotheca Company FAGUS SYLVATICA FLOWER 200 [hp_C]/mL 57520-0452_18d8428f-3a71-4494-af48-61a4a78ea383 57520-0452 HUMAN OTC DRUG Prostoforce Aralia quinquefolia, Damiana, Hydrocotyle asiatica, Juniperus virginiana, Pareira brava, Sabal serrulata, Thuja occidentalis, Clematis erecta, Conium maculatum, Pulsatilla, LIQUID ORAL 20101115 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; CENTELLA ASIATICA; CHONDRODENDRON TOMENTOSUM ROOT; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; JUNIPERUS VIRGINIANA TWIG; PULSATILLA VULGARIS; SAW PALMETTO; THUJA OCCIDENTALIS LEAFY TWIG; TURNERA DIFFUSA LEAFY TWIG 3; 3; 3; 12; 12; 3; 12; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0453_988a56bb-dde6-4129-a34a-02f008af2b6c 57520-0453 HUMAN OTC DRUG hcgPLUS Coenzyme Q-10, Cyanocobalamin, Folic acid, L-carnitine, Taurine, Biotin, Proline, LIQUID ORAL 20100802 UNAPPROVED HOMEOPATHIC Apotheca Company BIOTIN; CYANOCOBALAMIN; FOLIC ACID; LEVOCARNITINE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PROLINE; SOMATROPIN; TAURINE; UBIDECARENONE 8; 6; 6; 6; 30; 30; 8; 34; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 57520-0455_3eb9b1e5-5e8a-4cc5-8889-18ddb891cd2e 57520-0455 HUMAN OTC DRUG Hot Flash Rescue Capsicum annuum, Pulsatilla, Sanguinaria canadensis, LOTION TOPICAL 20110621 UNAPPROVED HOMEOPATHIC Apotheca Company CAPSICUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0457_0f1b590c-1669-4665-b1b3-2196ca43e0cd 57520-0457 HUMAN OTC DRUG Food Additives Berberis vulgaris, Chelidonium majus, Trifolium pratense, Glycyrrhiza glabra, Lappa major, Phytolacca decandra, Rhamnus frangula, LIQUID ORAL 20100604 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; FRANGULA ALNUS BARK; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; RED CLOVER; SODIUM SULFATE; STILLINGIA; ZANTHOXYLUM AMERICANUM BARK 4; 12; 12; 3; 3; 4; 4; 4; 12; 12; 4; 3; 12; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0459_098d07a6-c2c5-4c14-97ab-1fef4f04d58a 57520-0459 HUMAN OTC DRUG Albuminuriaforce Equisetum hyemale, Solidago virgaurea, Apis mellifica, Mercurius corrosivus, Nux moschata, Phosphorus, Terebinthina, LIQUID ORAL 20100603 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; EQUISETUM HYEMALE; MERCURIC CHLORIDE; NUTMEG; PHOSPHORUS; SOLIDAGO VIRGAUREA FLOWERING TOP; TURPENTINE 12; 3; 12; 12; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0460_ef4def8d-12f6-4f54-b70e-ad5630793e8a 57520-0460 HUMAN OTC DRUG Melatonin Melatonin, LIQUID ORAL 20100603 UNAPPROVED HOMEOPATHIC Apotheca Company MELATONIN 30 [hp_C]/mL 57520-0461_1fbdb6ba-5cce-4745-a663-a4b4e41fec75 57520-0461 HUMAN OTC DRUG Bio Gentian Gentian, LIQUID ORAL 20100603 UNAPPROVED HOMEOPATHIC Apotheca Company GENTIANA LUTEA ROOT 200 [hp_C]/mL 57520-0462_90956e1b-14fe-47a0-99ee-e10599cc0358 57520-0462 HUMAN OTC DRUG Bio Red Chestnut Red chestnut LIQUID ORAL 20100603 UNAPPROVED HOMEOPATHIC Apotheca Company AESCULUS CARNEA FLOWER 200 [hp_C]/mL 57520-0463_fce97825-532b-4e4d-b1b7-dc01bcd3a8b9 57520-0463 HUMAN OTC DRUG Fungustat I Ecninacea, Tabebuia impetiginosa, Abies nigra, Lycopodium clavatum, Nux vomica, Phosphorus, Pulsatilla, LIQUID ORAL 20100602 UNAPPROVED HOMEOPATHIC Apotheca Company CANDIDA ALBICANS; ECHINACEA; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PICEA MARIANA RESIN; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SKATOLE; STRYCHNOS NUX-VOMICA SEED; TABEBUIA IMPETIGINOSA BARK 30; 3; 12; 12; 12; 12; 12; 15; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0464_773ea16a-07da-46d9-b4e1-3ade3b41c9dc 57520-0464 HUMAN OTC DRUG Bac HP Apis mellifica, Arsenicum album, Belladonna, Chamomilla, Ecinacea, Lachesis mutus, Mercurius solubilis, LIQUID ORAL 20100602 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0466_f8bda96c-faf9-4d5d-9887-91946739e432 57520-0466 HUMAN OTC DRUG Lym D Chelidonium majus, Echinacea angustifolia, Hydrastis canadensis, Nasturtium aquaticum, Taraxacum officinale, Trifolium pratense, Urtica dioica, LIQUID ORAL 20100527 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BORRELIA BURGDORFERI; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PROTORTONIA CACTI; RED CLOVER; RORIPPA NASTURTIUM-AQUATICUM; SUS SCROFA THYMUS; TARAXACUM OFFICINALE; THYROID; TOXICODENDRON PUBESCENS LEAF; URTICA DIOICA 12; 200; 3; 3; 3; 200; 12; 12; 12; 3; 3; 8; 3; 8; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0467_0a756b33-b0ae-49a6-8d9c-8bd22e367b48 57520-0467 HUMAN OTC DRUG Metalogin Allium sativum, Berberis vulgaris, Glycyrrhiza glabra, Lappa major, Phytolacca Decandra, Rahmnus frangula, Stillingia sylvatica, LIQUID ORAL 20100527 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; ALUMINUM; ARCTIUM LAPPA ROOT; ARSENIC; BARIUM; BERBERIS VULGARIS ROOT BARK; BERYLLIUM; BORON; BROMINE; CADMIUM; CERIUM; CESIUM; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; FLUORINE; FRANGULA ALNUS BARK; GADOLINIUM; GALLIUM; GARLIC; GERMANIUM; GLYCYRRHIZA GLABRA; HOLMIUM; HYDROGEN; INDIUM; IODINE; IRON; LANTHANUM; LEAD; LITHIUM; LYCOPODIUM CLAVATUM SPORE; MANGANESE; MERCURY; METHIONINE; MOLYBDENUM; NEODYMIUM; NICKEL; NIOBIUM; NITROGEN; OXYGEN; PHYTOLACCA AMERICANA ROOT; PRASEODYMIUM; RED CLOVER; RUBIDIUM; SAMARIUM; SCANDIUM; SELENIUM; SELENIUM DIOXIDE; SILICON; SILVER; STILLINGIA SYLVATICA ROOT; STRONTIUM; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA THYROID; TANTALUM; TERBIUM; THULIUM; TIN; TITANIUM; YTTERBIUM; ZINC 30; 30; 3; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 3; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 12; 30; 30; 6; 30; 30; 30; 30; 30; 30; 3; 30; 3; 30; 30; 30; 30; 8; 30; 30; 3; 30; 12; 6; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0468_d9cefcef-4048-49a9-9d0c-0379c136ff3f 57520-0468 HUMAN OTC DRUG Thyro Tonic Chelidonium majus, Spongia tosta, Lac defloratum, Fucus vesiculosus, Hepar, Pituitary, Thyroidinum, Iodium, LIQUID ORAL 20100527 UNAPPROVED HOMEOPATHIC Apotheca Company CHELIDONIUM MAJUS; FERROUS IODIDE; FUCUS VESICULOSUS; IODINE; MOLYBDENUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK LIVER; POTASSIUM IODIDE; PULSATILLA VULGARIS; SKIM MILK; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITARY GLAND; THYROID 3; 12; 30; 12; 12; 12; 8; 12; 12; 8; 3; 100; 100 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0470_4e6f48a4-f792-4bae-9c9c-adea946215c9 57520-0470 HUMAN OTC DRUG Sciatic Rescue Phytolacca decandra, Gnaphalium polycephalum, Colocynthis, Gelsemium sempervirens, GEL TOPICAL 20110620 UNAPPROVED HOMEOPATHIC Apotheca Company CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT; PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM 6; 6; 1; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0472_dd0167ce-c3fc-4012-b598-367f439472ec 57520-0472 HUMAN OTC DRUG Sciatic Rescue Phytolacca decandra, Gnaphalium polycephalum, Colocynthis, Gelsemium sempervirens, GEL TOPICAL 20111121 UNAPPROVED HOMEOPATHIC Apotheca Company CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT; PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM 6; 6; 1; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0473_31b1d7cb-7c65-4615-87a8-94794e515c4c 57520-0473 HUMAN OTC DRUG HCGDelivery com Cyanocobalamin(B-12), Glandula suprarenalis suis(adrenal), Hepar suis(liver), Thyroidinum, Magnesia phosphorica, Natrum phosphoricum, Human chorionic gonadotropin(HCG), LIQUID ORAL 20101210 UNAPPROVED HOMEOPATHIC Apotheca Company CYANOCOBALAMIN; HUMAN CHORIONIC GONADOTROPIN; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PORK LIVER; SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYROID 60; 34; 60; 60; 60; 60; 60 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0474_2078d157-5fc6-480a-a424-81f60a9fdb51 57520-0474 HUMAN OTC DRUG Platinum for Men Cyanocobalamin, Glandula suprarenalis suis, Kali carbonicum, L-carnitine, L-glutamine, L-ornithine, L-tryptophan, L-tyrosine, LIQUID ORAL 20101123 UNAPPROVED HOMEOPATHIC Apotheca Company CYANOCOBALAMIN; GLUTAMINE; HUMAN CHORIONIC GONADOTROPIN; LEVOCARNITINE; ORNITHINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; SUS SCROFA THYROID; TRYPTOPHAN; TYROSINE 6; 6; 60; 6; 6; 12; 6; 6; 6; 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0477_be9d7935-5338-46c5-b137-4027fab553d7 57520-0477 HUMAN OTC DRUG Estrogen Folliculinum, Oophorinum, LIQUID ORAL 20100716 UNAPPROVED HOMEOPATHIC Apotheca Company ESTRONE; SUS SCROFA OVARY 6; 6 [hp_X]/mL; [hp_X]/mL 57520-0479_37d28834-1b1b-4550-8512-3b2f92c9f5b8 57520-0479 HUMAN OTC DRUG Hepastat Beta vulgaris, Carduus marianus, Taraxacum officinale, Cholesterinum, Fel tauri, Chelidonium majus, Lycopodium clavatum, LIQUID ORAL 20100604 UNAPPROVED HOMEOPATHIC Apotheca Company BETA VULGARIS; BOS TAURUS BILE; CHELIDONIUM MAJUS; CHOLESTEROL; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 3; 6; 12; 6; 12; 12; 3; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0480_d76778e0-9fc4-4382-9569-3f0fc4e06624 57520-0480 HUMAN OTC DRUG Envirostat Berberis vulgaris, Chelidonium majus, Lappa major, Phytolacca Decandra, Calcarea fluorica, Carbo animalis, Nux vomica, LIQUID ORAL 20100604 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTIUM LAPPA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM FLUORIDE; CARBO ANIMALIS; CHELIDONIUM MAJUS; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 12; 12; 3; 12; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0481_8bf94eaf-01fc-45d7-b331-3c4395c3fa49 57520-0481 HUMAN OTC DRUG Arnica Plus Arnica montana, Hamamelis virginiana, Rhus toxicodendron, GEL TOPICAL 20110113 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0482_f18cd6c8-c862-451f-8b34-53ba8479f1ae 57520-0482 HUMAN OTC DRUG Back and Neck Rescue Hypericum perforatum, Phytolacca decandra, Guaiacum, Ledum palustre, Conium maculatum, GEL TOPICAL 20110113 UNAPPROVED HOMEOPATHIC Apotheca Company CONIUM MACULATUM FLOWERING TOP; GUAIACUM OFFICINALE RESIN; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT 30; 6; 3; 6; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0484_19cc1248-4668-41db-be1f-2fc083050a74 57520-0484 HUMAN OTC DRUG Muscle Ice Phytolacca decandra, Symphytum officinale, Bellis perennis, Ledum palustre, Ruta graveolens, Magnesia phosphorica, Silicea, GEL TOPICAL 20110119 UNAPPROVED HOMEOPATHIC Apotheca Company BELLIS PERENNIS; COMFREY LEAF; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE 6; 3; 6; 9; 1; 6; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0489_7626465a-158f-408e-abf4-867824e42aac 57520-0489 HUMAN OTC DRUG Lung Large Intestine Aloe socotrina, Alumina, Apis mellifica LIQUID ORAL 20100611 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; ALOE; ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; LEAD; MATRICARIA RECUTITA; PHOSPHORUS; POTASSIUM DICHROMATE; RANCID BEEF; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0490_1229fc47-0176-4c06-a4db-22163b1fe4be 57520-0490 HUMAN OTC DRUG Progesterone Progesterone, LIQUID ORAL 20101207 UNAPPROVED HOMEOPATHIC Apotheca Company PROGESTERONE 6 [hp_X]/mL 57520-0491_40fa9780-5402-4075-a4fd-8d17511d0c11 57520-0491 HUMAN OTC DRUG Strength F Isoleucine, Arginine, Carnitine, Alpha keto glutaricum acid, Leucine, Ornithine, Valine, Estrogen, Progesterone, Testosterone, LIQUID ORAL 20101209 UNAPPROVED HOMEOPATHIC Apotheca Company .ALPHA.-KETOGLUTARIC ACID; ARGININE; CARNITINE; ESTRADIOL; ESTRIOL; ESTRONE; ISOLEUCINE; LEUCINE; ORNITHINE; PROGESTERONE; TESTOSTERONE; VALINE 6; 6; 6; 200; 200; 200; 6; 6; 6; 200; 200; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0493_c51c5d5d-792b-4534-83d6-4b0e76d38760 57520-0493 HUMAN OTC DRUG 3 Heart Phytolacca decandra, Spongia tosta, Aurum metallicum, Coffea cruda Crocus sativus, LIQUID ORAL 20100623 UNAPPROVED HOMEOPATHIC Apotheca Company ARABICA COFFEE BEAN; GOLD; PHYTOLACCA AMERICANA ROOT; SAFFRON; SPONGIA OFFICINALIS SKELETON, ROASTED 1; 1; 3; 1; 3 [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL 57520-0494_b0489ac0-01f8-40f2-ab76-9e22af921bb2 57520-0494 HUMAN OTC DRUG 12 Male Reproductive Chimaphila umbellata, Pituitary, Sabal serrulata, Uva-ursi, Gelsemium sempervirens, Sarsaparilla, Kali phosphoricum, Phosphoricum acidum, Zincum metallicum LIQUID ORAL 20100618 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; CHIMAPHILA UMBELLATA; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SARSAPARILLA; SAW PALMETTO; SUS SCROFA PITUITARY GLAND; ZINC 6; 3; 30; 1; 1; 30; 6; 3; 1 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_M]/mL 57520-0495_a2ca7ad9-b791-433c-b56f-021fc11cd260 57520-0495 HUMAN OTC DRUG Virustat Echinacea, Hydrastis canadensis, Lomatium, Acontium Napellus LIQUID ORAL 20100622 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; LOMATIUM; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3; 12; 3; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0497_6f501b18-c7cb-4410-90ad-40e5cd4713d1 57520-0497 HUMAN OTC DRUG Allerstat II Baptisia tinctoria, Echinacea, Allium cepa LIQUID ORAL 20100607 UNAPPROVED HOMEOPATHIC Apotheca Company AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ECHINACEA; EUPHRASIA STRICTA; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0498_c1730749-f8c4-4490-bb7d-117911de4db9 57520-0498 HUMAN OTC DRUG Parastat Artemisia vulgaris, Cina, Filix mas, Sabadilla, Spigelia anthelmia, LIQUID ORAL 20100622 UNAPPROVED HOMEOPATHIC Apotheca Company ARTEMISIA CINA FLOWER; ARTEMISIA VULGARIS ROOT; BARIUM CARBONATE; DRYOPTERIS FILIX-MAS ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SCHOENOCAULON OFFICINALE SEED; SPIGELIA; SULFUR; TURPENTINE 3; 3; 12; 3; 12; 3; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0499_5980342d-9cc9-4789-a930-88df0b6a14ad 57520-0499 HUMAN OTC DRUG Headache Tonic Cardsuus marianus, Pyrethrum parthenium, Secale cornutum, Aconitum napellus, Belladonna, Bryonia, LIQUID ORAL 20100621 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CLAVICEPS PURPUREA SCLEROTIUM; GELSEMIUM SEMPERVIRENS ROOT; MELILOTUS OFFICINALIS POLLEN; NITROGLYCERIN; SEPIA OFFICINALIS JUICE; SILYBUM MARIANUM SEED; SPIGELIA; STRYCHNOS NUX-VOMICA SEED; TANACETUM PARTHENIUM 12; 12; 12; 6; 12; 12; 12; 12; 1; 12; 12; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0500_8efa347a-b2da-4990-b2d0-59ec2f9373e1 57520-0500 HUMAN OTC DRUG Pneumoplex Plantago major, Arsenicum album, Lung, Symphytum officinale, Silicea, Phellandrium aquaticum, Phosphorus, Sulphur LIQUID ORAL 20100618 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; COMFREY ROOT; OENANTHE AQUATICA FRUIT; PHOSPHORUS; PLANTAGO MAJOR; SILICON DIOXIDE; SULFUR; SUS SCROFA LUNG 6; 6; 12; 12; 3; 8; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0501_be442d33-a554-45ff-beb3-2cbe81b281b9 57520-0501 HUMAN OTC DRUG Bactestat Baptisia tinctoria, Echinacea, Phytolacca decandra LIQUID ORAL 20100614 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; ECHINACEA; FERRUM PHOSPHORICUM; LACHESIS MUTA VENOM; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT 12; 12; 12; 3; 3; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0502_5011a034-d9c5-48ab-b8e1-786273963a15 57520-0502 HUMAN OTC DRUG HCG Cleanse Abrotanum, Anacardium orientale, Arsenicum album, Baryta muriatica, Helleborus niger, Ignatia amara, Lycopodium clavatum, SPRAY ORAL 20100811 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CHLORIDE DIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; HELLEBORUS NIGER ROOT; HUMAN CHORIONIC GONADOTROPIN; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; STRYCHNOS IGNATII SEED; SUS SCROFA THYMUS; SUS SCROFA THYROID; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0503_acaf0551-6fdf-4a5e-b215-947adc55f375 57520-0503 HUMAN OTC DRUG Dr. L Advanced HCG Formula Chromium GTF, Hypothalamus, HCG, Garcina cambogia, LIQUID ORAL 20100714 UNAPPROVED HOMEOPATHIC Apotheca Company BOS TAURUS HYPOTHALAMUS; CHORIOGONADOTROPIN ALFA; CHROMIUM PICOLINATE; HYDROXYCITRIC ACID 13; 34; 13; 34 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0504_158c3581-a313-48a6-9482-0ac6c9b608d0 57520-0504 HUMAN OTC DRUG MP Achyrocline satureioides, Arctostaphylos uva-ursi, Cassia occidentalis, Mirailis jalapa, Petiveria alliacea, Physalis angulata, Schinus molle, LIQUID ORAL 20101027 UNAPPROVED HOMEOPATHIC Apotheca Company ACHYROCLINE SATUREIOIDES; ARCTOSTAPHYLOS UVA-URSI LEAF; MIRABILIS JALAPA TOP; PETIVERIA ALLIACEA ROOT; PHYSALIS ANGULATA; SCHINUS MOLLE BARK; SENNA OCCIDENTALIS 32; 32; 32; 32; 32; 32; 32 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0505_09e2c99b-6201-44ae-90d7-65c93417b896 57520-0505 HUMAN OTC DRUG Parasite Detox Filix mas, Granatum, Juglans regia, Rhamnus purshiana, Absinthium, Aesculus hippocastanum, Arsenicum album, Baptisia tinctoria, LIQUID ORAL 20100623 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ARTEMISIA CINA FLOWER; BAPTISIA TINCTORIA ROOT; COPPER; DRYOPTERIS FILIX-MAS ROOT; FRANGULA PURSHIANA BARK; HORSE CHESTNUT; IPECAC; JUGLANS REGIA LEAF; KRAMERIA LAPPACEA ROOT; LYCOPODIUM CLAVATUM SPORE; MERCURY; PULSATILLA VULGARIS; PUNICA GRANATUM ROOT BARK; SANTONIN; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM; TOXICODENDRON PUBESCENS LEAF; WORMWOOD 15; 15; 15; 15; 3; 3; 15; 15; 3; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0509_21e8289c-a33e-47a5-afe9-76e06b071556 57520-0509 HUMAN OTC DRUG Vermex Artemisia vulgaris, Cina, Filix mas, Spigelia anthelmia, Teucrium marum, Calcarea carbonica, Graphites, LIQUID ORAL 20100622 UNAPPROVED HOMEOPATHIC Apotheca Company ARTEMISIA CINA FLOWER; ARTEMISIA VULGARIS ROOT; ASCARIS LUMBRICOIDES; DRYOPTERIS FILIX-MAS ROOT; GRAPHITE; MERCURIC CHLORIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA; TAENIA SOLIUM; TANACETUM VULGARE TOP; TEUCRIUM MARUM 3; 3; 200; 3; 12; 12; 12; 12; 12; 3; 200; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0510_e8e39779-dbcf-4cb9-a56e-21acb6b81f3c 57520-0510 HUMAN OTC DRUG Arterioforce II Baptisia tinctoria, Echinacea, Hydrastis canadensis LIQUID ORAL 20100624 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; ECHINACEA; FENUGREEK SEED; GOLDENSEAL; MYRRH; PHYTOLACCA AMERICANA ROOT; POTASSIUM IODIDE; PROPOLIS WAX; RORIPPA NASTURTIUM-AQUATICUM; SELENICEREUS GRANDIFLORUS STEM 6; 3; 12; 12; 12; 3; 4; 3; 4; 3; 5; 6; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0511_81db60ba-a6f4-4a9a-86a2-7df8dbc8b2ba 57520-0511 HUMAN OTC DRUG Enuresis Equisetum hyemale, Solidago virgaurea, Uva-ursi, Argentum metallicum, Causticum LIQUID ORAL 20100615 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; CAUSTICUM; EQUISETUM HYEMALE; NITRIC ACID; SEPIA OFFICINALIS JUICE; SILVER; SOLIDAGO VIRGAUREA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; WOOD CREOSOTE 3; 12; 3; 12; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0512_44463740-2eb6-4695-8a79-9778fbca357d 57520-0512 HUMAN OTC DRUG Pre/Post Surgery Hypericum perforatum, Symphytum officinale, Arnica montana LIQUID ORAL 20100618 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; COMFREY ROOT; HYPERICUM PERFORATUM 200; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0513_77438252-09db-4e44-978d-560dac98409f 57520-0513 HUMAN OTC DRUG Sinuforce Echinacea, Hydrastis canadensis, Nux moschata, Trigonalla foenum graecum, Arsenicum album, Kali bichromicum, Mercurius sulphuratus ruber, Pulsatilla, Sepia, Mercurius solubilis LIQUID ORAL 20100618 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ECHINACEA; FENUGREEK SEED; GOLDENSEAL; MERCURIC SULFIDE; MERCURIUS SOLUBILIS; NUTMEG; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 12; 3; 3; 3; 12; 30; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0514_1f275616-395a-4a30-9a92-3bb4583c1b69 57520-0514 HUMAN OTC DRUG Skin Relief Plus Aloe socotrina, Phosphorus, Silicea, Sulphur, LIQUID ORAL 20100722 UNAPPROVED HOMEOPATHIC Apotheca Company ALOE; PHOSPHORUS; SILICON DIOXIDE; SULFUR 200; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0515_a5b1bb8b-ae6e-41ad-b263-71b6a530a418 57520-0515 HUMAN OTC DRUG Menadione Menadione, LIQUID ORAL 20100616 UNAPPROVED HOMEOPATHIC Apotheca Company MENADIONE 30 [hp_C]/mL 57520-0516_f42417ba-96dc-44b7-95b1-5d1b4f1be522 57520-0516 HUMAN OTC DRUG Bio Chestnut Bud Chestnut bud LIQUID ORAL 20100714 UNAPPROVED HOMEOPATHIC Apotheca Company AESCULUS HIPPOCASTANUM FLOWER 200 [hp_C]/mL 57520-0517_faee4ef4-eb03-423f-91f0-3b7d5debbdb3 57520-0517 HUMAN OTC DRUG Bio Holly Holly, LIQUID ORAL 20100616 UNAPPROVED HOMEOPATHIC Apotheca Company ILEX AQUIFOLIUM FLOWERING TOP 200 [hp_C]/mL 57520-0518_32bee6c5-0e7c-4b91-bd84-282c64a149a3 57520-0518 HUMAN OTC DRUG Lym D HP Arsenicum album, Chelidonium majus, Coccus cacti, Echinacea angustifolia, Hydrastis canadensis, Lycopodium clavatum, LIQUID ORAL 20100715 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BORRELIA BURGDORFERI; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PROTORTONIA CACTI; RORIPPA NASTURTIUM-AQUATICUM; TARAXACUM OFFICINALE; THYMUS; THYROID; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE POLLEN; URTICA DIOICA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0519_eefc36b3-d640-41fb-9109-ada6ddfc5d8e 57520-0519 HUMAN OTC DRUG Grain and Seed Antigen Barley, Oats, Wheat, Rice, Rye, Millet, Soybean, Corn, Milo, Bamboo, Cotton seed, Flax seed, LIQUID ORAL 20100721 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BAMBUSA VULGARIS TOP; BARLEY; CORN; COTTON SEED; FLAX SEED; HELIANTHUS ANNUUS; LYCOPODIUM CLAVATUM SPORE; MILLET; OAT; POPPY SEED; RICE; RYE; SAFFLOWER; SESAME; SODIUM CHLORIDE; SORGHUM BICOLOR SSP. BICOLOR POLLEN; SOYBEAN; SUGARCANE; SULFUR; WHEAT 12; 30; 30; 30; 30; 30; 30; 12; 30; 30; 30; 30; 30; 30; 30; 12; 30; 30; 30; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0520_d554a2f1-2f22-48a3-93cc-dadf60d91eb8 57520-0520 HUMAN OTC DRUG Nux Vomica Nux vomica, PELLET ORAL 20110616 UNAPPROVED HOMEOPATHIC Apotheca Company STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/g 57520-0521_fc668c11-b2c5-40a0-90cc-8cc5a9f7cdac 57520-0521 HUMAN OTC DRUG Ear Inflammation Plus Belladonna, Conium maculatum, Dulcamara, LIQUID ORAL 20100624 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SOLANUM DULCAMARA TOP 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0522_a1565ba4-68aa-47e0-bcba-b8f9f8d934e7 57520-0522 HUMAN OTC DRUG Allersode II Allium cepa, Ambrosia artemisiaefolia, Euphrasia officinalis LIQUID ORAL 20100625 UNAPPROVED HOMEOPATHIC Apotheca Company ACER NEGUNDO POLLEN; AGROSTIS GIGANTEA; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ARSENIC TRIOXIDE; BETULA OCCIDENTALIS POLLEN; CARYA OVATA POLLEN; DACTYLIS GLOMERATA; EUPHRASIA STRICTA; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; HISTAMINE DIHYDROCHLORIDE; JUGLANS NIGRA POLLEN; ONION; PHLEUM PRATENSE; PHOSPHORUS; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS; POPULUS DELTOIDES POLLEN; PORK LIVER; PULSATILLA VULGARIS; QUERCUS RUBRA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SCHOENOCAULON OFFICINALE SEED; SULFUR; SUS SCROFA ADRENAL GLAND; ULMUS AMERICANA POLLEN 26; 26; 26; 3; 26; 26; 26; 12; 26; 26; 26; 3; 26; 26; 30; 26; 3; 26; 12; 26; 26; 26; 24; 12; 26; 26; 26; 26; 6; 12; 24; 26 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0523_a94cdc15-3ba4-4816-b57f-be354878b5c7 57520-0523 HUMAN OTC DRUG GABA Gaba LIQUID ORAL 20100714 UNAPPROVED HOMEOPATHIC Apotheca Company .GAMMA.-AMINOBUTYRIC ACID 6 [hp_X]/mL 57520-0524_dad96e2f-1be4-43fa-a53e-52c5b1273c7a 57520-0524 HUMAN OTC DRUG Joint Pain Arnica montana, Bryonia alba, Causticum, Rhus toxicodendron, Ferrum phosphoricum LIQUID ORAL 20100618 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; FERRUM PHOSPHORICUM; TOXICODENDRON PUBESCENS LEAF 4; 4; 4; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0525_7677d3a0-664e-4dcf-8d8e-c03b443f2e5b 57520-0525 HUMAN OTC DRUG Diathesis IV Fel tauri, Ginkgo biloba, Kidney, Germanium sesquioxide, Argentum metallicum, Cuprum metallicum, Cysteinum, Aurum metallicum, Manganum gluconicum, LIQUID ORAL 20110215 UNAPPROVED HOMEOPATHIC Apotheca Company .ALPHA.-KETOGLUTARIC ACID; BOS TAURUS BILE; COPPER; CYSTEINE; FUMARIC ACID; GERMANIUM SESQUIOXIDE; GINKGO; GOLD; MANGANESE GLUCONATE; MERCURIUS SOLUBILIS; PHOSPHORIC ACID; PORK KIDNEY; SILVER; SODIUM OXALATE; STRYCHNOS NUX-VOMICA SEED 12; 30; 9; 9; 12; 8; 6; 12; 10; 12; 12; 30; 9; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0526_0d561306-63fd-47c7-9324-f2b5732da8c4 57520-0526 HUMAN OTC DRUG Anti Hive Ammonium carbonicum, Apis mellifica, Argentum metallicum, Arsenicum album, Dulcamara, Mezereum, Ehus toxicodendron, Urtica urens, LIQUID ORAL 20110211 UNAPPROVED HOMEOPATHIC Apotheca Company AMMONIUM CARBONATE; APIS MELLIFERA; ARSENIC TRIOXIDE; DAPHNE MEZEREUM BARK; SILVER; SOLANUM DULCAMARA TOP; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0527_faaff7dd-1fa2-468b-8491-fa4269c77824 57520-0527 HUMAN OTC DRUG Endo Pure Testos (for Women) DNA, RNA, Sabal serrulata, Cortisol (hydrocortisone), Glandula suprarenalis, Hypothalamus, Pituitary, Testosterone, Chelidonium majus, Thuja occidentalis, LIQUID ORAL 20101210 UNAPPROVED HOMEOPATHIC Apotheca Company CHELIDONIUM MAJUS; HERRING SPERM DNA; HYDROCORTISONE; SACCHAROMYCES CEREVISIAE RNA; SAW PALMETTO; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; TESTOSTERONE; THUJA OCCIDENTALIS LEAFY TWIG 12; 6; 6; 6; 6; 6; 6; 6; 6; 12 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0528_02350e1d-ab21-4936-ada5-70235f810391 57520-0528 HUMAN OTC DRUG Infectistat Baptisia tinctoria, Echinacea, Hydrastis canadensis, Lobelia inflata, Lomatium, Phytolacca decandra, Symphytum officinale, Lung, Aconitum napellus, Arsenicum album, Belladonna, Bryonia, Causticum, LIQUID ORAL 20101210 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAUSTICUM; COMFREY ROOT; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; SODIUM SULFATE; SULFUR; SUS SCROFA LUNG; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3; 3; 12; 12; 12; 3; 12; 12; 3; 3; 12; 3; 12; 12; 30; 12; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0529_c2f7f84e-5c5b-4869-978b-c3f5884d9779 57520-0529 HUMAN OTC DRUG Virotox WN Echinacea angustifolia, Hydrastis canadensis, Lomatium, Myrrha, Nasturtium aquaticum, Tabebuia impetiginosa, Glandula suprarenalis, Thymus LIQUID ORAL 20101207 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MYRRH; RANCID BEEF; RORIPPA NASTURTIUM-AQUATICUM; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; WEST NILE VIRUS 12; 3; 12; 3; 3; 12; 3; 200; 3; 12; 8; 8; 3; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0530_82be2c63-8e3c-49c6-83e0-960fa8232a85 57520-0530 HUMAN OTC DRUG Anxiety II HP Aconitum napellus, Arsenicum album, Belladonna, Calcarea carbonica, Carcinosin, Causticum, Gelsemium sempervirens, Lachesis mutus, SPRAY ORAL 20101207 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CAUSTICUM; GELSEMIUM SEMPERVIRENS ROOT; HUMAN BREAST TUMOR CELL; LACHESIS MUTA VENOM; MERCURY; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0531_0e68f85c-172c-4e64-873a-cce1d38f0f9e 57520-0531 HUMAN OTC DRUG Thymus Thymus, SPRAY ORAL 20101207 UNAPPROVED HOMEOPATHIC Apotheca Company SUS SCROFA THYMUS 8 [hp_X]/mL 57520-0532_75e36dd0-fdd7-435c-b579-fd78ef25522c 57520-0532 HUMAN OTC DRUG Vertiforce Leonurus cardiaca, Agaricus muscarius, Arsenicum album, Cocculus indicus, Conium maculatum, Petroleum, Phosphorus, Pulsatilla, Tabacum, Theridion, LIQUID ORAL 20101207 UNAPPROVED HOMEOPATHIC Apotheca Company AMANITA MUSCARIA VAR. MUSCARIA; ANAMIRTA COCCULUS SEED; ARSENIC TRIOXIDE; CONIUM MACULATUM FLOWERING TOP; KEROSENE; LEONURUS CARDIACA; PHOSPHORUS; PULSATILLA VULGARIS; THERIDION CURASSAVICUM; TOBACCO LEAF 12; 12; 12; 12; 12; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0535_55b09121-0798-4700-b235-eb213dcebce4 57520-0535 HUMAN OTC DRUG Liver Tonic I Carduus marianus, Chelidonium majus, Taraxacum officinale, Chionanthus virginica, Quassia amara, Hepar bovinum, LIQUID ORAL 20100714 UNAPPROVED HOMEOPATHIC Apotheca Company BEEF LIVER; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CULVER'S ROOT; PHOSPHORUS; QUASSIA AMARA WOOD; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TEUCRIUM MARUM 200; 12; 1; 3; 12; 12; 12; 3; 1; 12; 12; 1; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0539_34fd3857-e3c4-4228-a2a7-a3dcdb229a40 57520-0539 HUMAN OTC DRUG Neuralgia HP Agaricus muscarius, Arnica montana, Hypericum perforatum, phosphorus, Plumbum metallicum, Mercurius solubilis, Allium cepa, Lycopodium clavatum, LIQUID ORAL 20100716 UNAPPROVED HOMEOPATHIC Apotheca Company AMANITA MUSCARIA VAR. MUSCARIA; ARNICA MONTANA; HYPERICUM PERFORATUM; LEAD; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; ONION; PHOSPHORUS 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0542_c47df08e-9f63-4917-b1c1-2d015dc7ac0f 57520-0542 HUMAN OTC DRUG Quercetin Quercetin, LIQUID ORAL 20101208 UNAPPROVED HOMEOPATHIC Apotheca Company QUERCETIN 30 [hp_C]/mL 57520-0544_04e17358-a418-4fdc-bf49-4519c221a896 57520-0544 HUMAN OTC DRUG Sciatica HP Aconitum napellus, Aesculus hippocastanum, Colchicum autumnale, Hypericum perforatum, Magnesia phosphorica, Plumbum metallicum, Rhus toxicodendron, Arnica Montana, LIQUID ORAL 20101210 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARNICA MONTANA; COLCHICUM AUTUMNALE BULB; HORSE CHESTNUT; HYPERICUM PERFORATUM; LEAD; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0545_95e55a0d-8b14-4fe0-8396-012b5e9710b3 57520-0545 HUMAN OTC DRUG Hot Flash Rescue Capsicum annuum, Pulsatilla, Sanguinaria canadensis, SPRAY TOPICAL 20110607 UNAPPROVED HOMEOPATHIC Apotheca Company PAPRIKA; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0546_65ae67dd-a629-40b1-a1be-0b5f5000f5f7 57520-0546 HUMAN OTC DRUG Ovaplex Angelica archangelica, Caulophyllum thalictroides, Dioscorea villosa, Oophorinum, Pituitary, Thyroidinum, Uterus, Zincum gluconicum, Apis mellifica, LIQUID ORAL 20101214 UNAPPROVED HOMEOPATHIC Apotheca Company ANGELICA ARCHANGELICA ROOT; APIS MELLIFERA; ATROPA BELLADONNA; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; DIOSCOREA VILLOSA ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEPIA OFFICINALIS JUICE; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; SUS SCROFA UTERUS; ZINC GLUCONATE 3; 12; 12; 12; 3; 3; 12; 12; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0547_f4edc561-c578-4b23-a17d-5151f1878f0f 57520-0547 HUMAN OTC DRUG Injury Topical Arnica montana, Calendula officinalis, Hypericum perforatum, Symphytum officinale, Bellis perennis, Carbo vegetabilis, GEL TOPICAL 20100726 UNAPPROVED HOMEOPATHIC Apotheca Company ACHILLEA MILLEFOLIUM; ACTIVATED CHARCOAL; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 12; 12; 3; 12; 1; 3; 12; 12; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0548_c28591f3-0488-4e74-814a-5f2486f68e27 57520-0548 HUMAN OTC DRUG NADH Plus Nadidum, Adenosinum cyclophosphoricum, Calcium D - pantothenate,Cholinum, Riboflavinum, Ubiquinone, Dimethyl glycine, SPRAY ORAL 20101007 UNAPPROVED HOMEOPATHIC Apotheca Company ADENOSINE CYCLIC 3',5'-PHOSPHATE; CALCIUM PANTOTHENATE; CHOLINE HYDROXIDE; GLYCINE; NADIDE; RIBOFLAVIN; UBIDECARENONE 6; 6; 6; 7; 4; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0549_370c33af-ffc9-40cb-93ed-7a299f21cccb 57520-0549 HUMAN OTC DRUG Tri Estrogen Folliculinum, Oophorinum, LIQUID ORAL 20101011 UNAPPROVED HOMEOPATHIC Apotheca Company ESTRONE; SUS SCROFA OVARY 6; 6 [hp_X]/mL; [hp_X]/mL 57520-0550_41186316-30fc-414e-ac91-32b84c1fa946 57520-0550 HUMAN OTC DRUG Thyroid HP Baryta carbonica, Calcarea carbonica, Fucus vesiculosus, Iodium, Natrum muriaticum, Pulsatilla, Spongia tosta, Thyroidinum, LIQUID ORAL 20101008 UNAPPROVED HOMEOPATHIC Apotheca Company BARIUM CARBONATE; FUCUS VESICULOSUS; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0551_e64930cc-8aba-4d00-9501-859fac705a2f 57520-0551 HUMAN OTC DRUG Prostatone Echinacea, Hydrastis canadensis, Phytolacca decandra, Sabal serrulata, Sarsaparilla, Solidago virgaurea, Zincum sulphuricum, LIQUID ORAL 20100716 UNAPPROVED HOMEOPATHIC Apotheca Company CLEMATIS RECTA FLOWERING TOP; ECHINACEA; GOLDENSEAL; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SARSAPARILLA ROOT; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA PROSTATE; SUS SCROFA TESTICLE; ZINC SULFATE HEPTAHYDRATE 12; 3; 3; 12; 3; 12; 3; 3; 3; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0552_8cfbee0c-af38-4321-8210-6dfc99496b15 57520-0552 HUMAN OTC DRUG Gastrotone Capsicum annuum, Foeniculum vulgare, Symphytum officinale, Argentum nitricum, Arsenicum album, Magnesia phosphorica, Pulsatilla, LIQUID ORAL 20100721 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; CAPSICUM; COMFREY ROOT; FENNEL SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PULSATILLA VULGARIS; SILVER NITRATE 12; 3; 3; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0554_b57733ff-2d8f-4f11-9f6f-53b7fa684859 57520-0554 HUMAN OTC DRUG Chemsode Triticum aestivum, Glycyrrhiza glabra, Lappa major, Phytolacca decandra, Rhamnus purshiana, Trifolium pratense, Nitricum acidum, LIQUID ORAL 20100716 UNAPPROVED HOMEOPATHIC Apotheca Company ACETIC ACID; ARCTIUM LAPPA ROOT; ATROPA BELLADONNA; BEEF LIVER; BENZOIC ACID; BENZYL ALCOHOL; BORIC ACID; BOS TAURUS ADRENAL GLAND; CHLORINE; CORTICOTROPIN; CORTISONE ACETATE; ESTRONE; EUGENOL; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LEAD; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PETROLATUM; PHENYLBUTAZONE; PHOSPHORIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PORK KIDNEY; POTASSIUM SORBATE; RED CLOVER; RESORCINOL; SALICYLIC ACID; SORBITOL; STEARYL ALCOHOL; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA LYMPH; WHEAT; XYLITOL 200; 3; 12; 8; 200; 200; 200; 8; 200; 200; 200; 200; 200; 3; 3; 200; 200; 200; 12; 12; 200; 200; 12; 12; 3; 8; 200; 3; 200; 200; 200; 200; 12; 8; 1; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0555_02b09574-b118-48d6-8900-f48641731e3d 57520-0555 HUMAN OTC DRUG Homeopathic HCG L-arginine, L-carnitine, L-ornithine, L-tyrosine, HCG(Human chorionic conadotropin, LIQUID ORAL 20100809 UNAPPROVED HOMEOPATHIC Apotheca Company ARGININE; HUMAN CHORIONIC GONADOTROPIN; LEVOCARNITINE HYDROCHLORIDE; ORNITHINE; TYROSINE 6; 34; 6; 6; 6 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; mL/mL; [hp_X]/mL 57520-0556_8d2e5d3f-acba-45de-a296-d6fa7d157906 57520-0556 HUMAN OTC DRUG Compre Tox Eriodictyon californicum, Hamamelis virginiana, Nymphaea odorata, Plantago major, Xanthoxylum fraxineum, Xerophyllum asphodeloides, LIQUID ORAL 20101025 UNAPPROVED HOMEOPATHIC Apotheca Company ERIODICTYON CALIFORNICUM LEAF; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; NYMPHAEA ODORATA ROOT; PLANTAGO MAJOR; XEROPHYLLUM ASPHODELOIDES; YUCCA FILAMENTOSA; ZANTHOXYLUM AMERICANUM BARK 3; 3; 3; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0557_a05f627a-bff9-4d66-ad94-ba2e802c9d6a 57520-0557 HUMAN OTC DRUG ANX HP Arsenicum album, Calcarea carbonica, Ignatia amara Kali carbonicum, Lachesis mutus, Natrum muriaticum, LIQUID ORAL 20100721 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0559_b34b64a5-e3be-4c56-a41c-5013d34f80db 57520-0559 HUMAN OTC DRUG Aconite Aconitum napellus, PELLET ORAL 20100922 20150813 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS 12 [hp_X]/mL 57520-0560_0ecae910-adc6-48aa-a5b4-bb6f9a398d4b 57520-0560 HUMAN OTC DRUG Arnica Arnica montana PELLET ORAL 20101012 20150813 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA 12 [hp_X]/mL 57520-0561_3d0fa488-ec25-4846-85e0-d33a1a0effc3 57520-0561 HUMAN OTC DRUG Rhus Tox Rhus toxicodendron, PELLETS, COATED, EXTENDED RELEASE ORAL 20100927 20150813 UNAPPROVED HOMEOPATHIC Apotheca Company TOXICODENDRON PUBESCENS LEAF 12 [hp_X]/mL 57520-0563_aae392d0-2cae-4080-918b-1a00324cc605 57520-0563 HUMAN OTC DRUG Traumatone Calendula officinalis, Symphytum officinale, Staphysagria, Rhus Toxicodendron, Ruta Graveolens, Bellis perennis, LIQUID ORAL 20100722 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; STRONTIUM CARBONATE; TOXICODENDRON PUBESCENS LEAF 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0565_99854984-cdf9-429f-8131-058f952a3418 57520-0565 HUMAN OTC DRUG Sinuchron HP Arsenicum album, Hepar sulphuris calcareum, Kali bichromicum, Lycopodium clavatum, Mercurius solubilis, Natrum muriaticum, Phosphorus, Pulsatilla, Sepia, LIQUID ORAL 20101214 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; CALCIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0566_60a5a469-47a1-4f0c-8422-63793c651069 57520-0566 HUMAN OTC DRUG Ginkgo Tonic Aralia quinquefolia, Ginkgo biloba, Hydrocotyle asiatica, Polygonum multiflorum, Aronia melanocarpa, Vaccinium myrtillus, Germanium sesquioxide, Aurum metallicum Baryta muriatica, LIQUID ORAL 20101220 UNAPPROVED HOMEOPATHIC Apotheca Company ADENOSINE TRIPHOSPHATE; AMERICAN GINSENG; ARONIA MELANOCARPA FRUIT; BARIUM CHLORIDE DIHYDRATE; BILBERRY; CENTELLA ASIATICA; CLAVICEPS PURPUREA SCLEROTIUM; FALLOPIA MULTIFLORA ROOT; GERMANIUM SESQUIOXIDE; GINKGO; GOLD; LEAD; POTASSIUM PHOSPHATE, DIBASIC; TOBACCO LEAF; UBIDECARENONE; VISCUM ALBUM FRUITING TOP 30; 1; 3; 12; 3; 1; 12; 1; 12; 1; 12; 12; 12; 12; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0568_8d488ac3-b059-49a3-9967-80c2eef073b0 57520-0568 HUMAN OTC DRUG Bio Chicory Chicory LIQUID ORAL 20101229 UNAPPROVED HOMEOPATHIC Apotheca Company CICHORIUM INTYBUS FLOWER 200 [hp_C]/mL 57520-0569_1e27b843-12a4-4a6d-a488-a17b3f693770 57520-0569 HUMAN OTC DRUG Free Radical Triticum aestivum, Alfalfa, Fucus vesiculosus, Laminaria digitata, Nasturtium aquaticum, Oryza sativa, Raphanus sativus, Symphytum officinale, Hordeum vulgare, Asparagus officinalis, Manganum gluconat LIQUID ORAL 20101227 UNAPPROVED HOMEOPATHIC Apotheca Company .ALPHA.-KETOGLUTARIC ACID; ALFALFA; ALUMINUM; ARNICA MONTANA; ARSENIC; ASPARAGUS; BARIUM CARBONATE; BERYLLIUM; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; COBALT; COMFREY ROOT; COPPER; COPPER; D&C BLACK NO. 2; DYSPROSIUM; ERBIUM; EUROPIUM; FERRUM PHOSPHORICUM; FUCUS VESICULOSUS; GADOLINIUM; GERMANIUM SESQUIOXIDE; GLYOXAL; HOLMIUM; HORDEUM VULGARE TOP; HYDROGEN; INDIUM; IODINE; IRON; LAMINARIA DIGITATA; LANTHANUM; LEAD; LITHIUM; MANGANESE; MANGANESE GLUCONATE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM; NICKEL; NIOBIUM; NITROGEN; OXYGEN; PRASEODYMIUM; RADISH; RICE; RORIPPA NASTURTIUM-AQUATICUM; RUBIDIUM; SAMARIUM; SCANDIUM; SELENIUM; SILICON DIOXIDE; SILVER; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; TIN; TITANIUM; UBIDECARENONE; WHEAT; YTTERBIUM; ZINC 30; 3; 30; 12; 30; 6; 30; 30; 30; 30; 30; 30; 30; 30; 3; 12; 30; 30; 30; 30; 30; 8; 3; 30; 30; 30; 30; 6; 30; 30; 30; 30; 3; 30; 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 30; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 12; 1; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0570_b383c68a-73dc-480b-9841-86e4b01bb0c9 57520-0570 HUMAN OTC DRUG Rescue Cherry plum, Clematis, Impatiens, Rock Rose, Star of bethlehem, LIQUID ORAL 20110103 UNAPPROVED HOMEOPATHIC Apotheca Company CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER 200; 200; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_M]/mL 57520-0571_2ac8ed04-3819-43c4-a911-d81b57d5713c 57520-0571 HUMAN OTC DRUG Fngsode Ceanothus americanus, Condurango, Echinacea angustifolia, Hydrastis canadensis, Ligusticum porteri, Lomatium, Nasturtium aquaticum, Tabebuia impetiginosa, Astragalus membranaceus, LIQUID ORAL 20101221 UNAPPROVED HOMEOPATHIC Apotheca Company ASTRAGALUS PROPINQUUS ROOT; CANDIDA ALBICANS; CEANOTHUS AMERICANUS LEAF; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LIGUSTICUM PORTERI ROOT; LOMATIUM DISSECTUM ROOT; MARSDENIA CONDURANGO BARK; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PORK KIDNEY; PROPOLIS WAX; RORIPPA NASTURTIUM-AQUATICUM; SEPIA OFFICINALIS JUICE; SODIUM BORATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK 6; 100; 1; 3; 3; 3; 3; 3; 12; 12; 60; 6; 3; 12; 12; 60; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0572_4debf365-33de-46eb-9bac-c417d88e5e5c 57520-0572 HUMAN OTC DRUG Adrenal Tincture Chelidonium majus, Echinacea, Glandula suprarenalis bovinum, Spleen, Carduus marianus, Natrum mutiaticum, Phosphoricum acidum, LIQUID ORAL 20101229 UNAPPROVED HOMEOPATHIC Apotheca Company BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; CHELIDONIUM MAJUS; ECHINACEA; PHOSPHORIC ACID; SILYBUM MARIANUM SEED; SODIUM CHLORIDE 24; 24; 3; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0574_af799f49-f4a0-47c3-bdf6-316c02926ae1 57520-0574 HUMAN OTC DRUG Bio Chem Detox Berberis vulgaris, Glycyrrhiza glabra, Lappa major, Phytolacca decandra, Rhamnus purshiana, Stillingia sylvatica, Trifolium pratense, Triticum aestivum, Xanthoxylum fraxineum, Glandula suprarenalis, H SPRAY ORAL 20101229 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ACTIVATED CHARCOAL; AMANITA MUSCARIA VAR. MUSCARIA; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; CHONDRODENDRON TOMENTOSUM ROOT; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; NITRIC ACID; PHOSPHORIC ACID; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED; PHYTOLACCA AMERICANA ROOT; PORK LIVER; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA THYROID; TOBACCO LEAF; TRIFOLIUM PRATENSE FLOWER; WHEAT; ZANTHOXYLUM AMERICANUM BARK 30; 30; 30; 3; 30; 30; 3; 200; 30; 30; 3; 3; 30; 12; 30; 30; 12; 30; 30; 3; 6; 3; 12; 30; 6; 6; 6; 30; 3; 3; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0575_0d249ea2-c346-464e-8444-a90724829c05 57520-0575 HUMAN OTC DRUG Sinus Tonic Echinacea, Baptisia tinctoria, Hydrastis canadensis, Thiaminum hydrochloricum, Pantothenic acid, Pyridoxinum hydrochloricum, Spongia tosta, Apis mellifica, Ascorbic acid, Hepar sulphuris calcareum LIQUID ORAL 20101217 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ASCORBIC ACID; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; ECHINACEA; GOLDENSEAL; LACHESIS MUTA VENOM; MERCURIC IODIDE; MERCURIC SULFIDE; PANTOTHENIC ACID; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; SILICON DIOXIDE; SINUSITISINUM; SPONGIA OFFICINALIS SKELETON, ROASTED; THIAMINE HYDROCHLORIDE 12; 12; 3; 12; 2; 3; 12; 12; 12; 6; 12; 12; 6; 12; 200; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0576_35870313-82bc-4e30-9fb1-32e79281e216 57520-0576 HUMAN OTC DRUG Dr L Advanced HCG Formula Chromium GTF, Hypothalamus, Human chorionic gonadotropin, Garcinia cambogia, LIQUID ORAL 20110215 UNAPPROVED HOMEOPATHIC Apotheca Company CHROMIUM PICOLINATE; GARCINIA CAMBOGIA FRUIT; HUMAN CHORIONIC GONADOTROPIN; SUS SCROFA HYPOTHALAMUS 13; 34; 34; 13 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0581_d859bf73-bf70-44d6-90c6-457cd7d6b317 57520-0581 HUMAN OTC DRUG Sciatica Relief Capsicum annuum, Colocynthis, Gnaphalium polycephalum, Magnesia phosphorica, TABLET ORAL 20110317 UNAPPROVED HOMEOPATHIC Apotheca Company CAPSICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57520-0582_4a3b8e30-239b-4bea-9166-ac421a6f4f26 57520-0582 HUMAN OTC DRUG Fibromyalgia Relief Aconitum napellus, Arsenicum album, Belladonna, Coniinum, Gelsemium sempervirens, Hypericum perforatum, Kali bichromicum, Lacticum acidum, Phosphoricum acidum, Rhus toxicodendrom, Uricum acidum, TABLET ORAL 20110607 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CONIINE; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; LACTIC ACID, DL-; PHOSPHORIC ACID; POTASSIUM DICHROMATE; TOXICODENDRON PUBESCENS LEAF; URIC ACID 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 57520-0584_82bb6e5a-f784-4e2d-9a46-37838b48fb20 57520-0584 HUMAN OTC DRUG Back and Neck Rescue Hypericum perforatum, Phytolacca decandra, Guaiacum, Ledum palustre, Conium maculatum, GEL TOPICAL 20110608 UNAPPROVED HOMEOPATHIC Apotheca Company CONIUM MACULATUM FLOWERING TOP; GUAIACUM OFFICINALE RESIN; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT 30; 6; 3; 6; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0585_c0fcd3ca-4f33-4abe-9b90-536d78844e09 57520-0585 HUMAN OTC DRUG Bio Larch Larch, LIQUID ORAL 20110113 UNAPPROVED HOMEOPATHIC Apotheca Company LARIX DECIDUA FLOWERING TOP 200 [hp_C]/mL 57520-0586_ef9d48f3-3a03-454b-89db-3830c3980377 57520-0586 HUMAN OTC DRUG Cough Drosera rotundifolia, Coccus cacti, Spongia tosta, Belladonna, Cuprum aceticum, Kali carbonicum, Mentha piperita, Phosphorus, SYRUP ORAL 20110111 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; MENTHA PIPERITA; PHOSPHORUS; POTASSIUM CARBONATE; PROTORTONIA CACTI; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 12; 3; 12; 12; 12; 5; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0587_640f4a78-b3fd-4bc2-ae93-22104d92c227 57520-0587 HUMAN OTC DRUG Endoplex F Cimicifuga racemosa , Fucus vesiculosus, Glycyrrhiza glabra, Xanthoxylum fraxineum, Adrenalinum, Brain, Hypothalamus, Oophorinum, Pineal, Pituitarum posterium, Thyroidinum, Pulsatilla, Sepia, LIQUID ORAL 20110120 UNAPPROVED HOMEOPATHIC Apotheca Company BLACK COHOSH; EPINEPHRINE; FUCUS VESICULOSUS; GLYCYRRHIZA GLABRA; PORK BRAIN; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; ZANTHOXYLUM AMERICANUM BARK 3; 8; 3; 3; 8; 12; 12; 8; 8; 8; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0588_097ebc61-1044-4501-a7e6-dd61ad7ec293 57520-0588 HUMAN OTC DRUG Strength M Aralia quinquefolia, Avena sativa, Damiana, Androstenedione, Arginine, Epimedium, Glutathione, Leucine, Ornithine, Valine, Testosterone, Sabal serrulata, Sepia, LIQUID ORAL 20110106 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; ANDROSTENEDIONE; ARGININE; AVENA SATIVA FLOWERING TOP; EPIMEDIUM GRANDIFLORUM FLOWERING TOP; GLUTATHIONE; LEUCINE; ORNITHINE; SAW PALMETTO; SEPIA OFFICINALIS JUICE; TESTOSTERONE; TURNERA DIFFUSA LEAFY TWIG; VALINE 3; 6; 6; 3; 6; 6; 6; 6; 24; 30; 12; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0589_28c4e5cb-a852-4b27-9e15-94e7c565f763 57520-0589 HUMAN OTC DRUG Menopause HP Belladonna, Lachesis mutus, Nux vomica, Pulsatilla, Secale cornutum, Sepia, Ustilago maidis, LIQUID ORAL 20110113 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; CLAVICEPS PURPUREA SCLEROTIUM; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; USTILAGO MAYDIS 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0590_a696c848-f2b5-402c-a2c6-1822a97dae81 57520-0590 HUMAN OTC DRUG Prostatone HP Clematis erecta, Conium maculatum, Lycopodium clavatum, Mercurius corrosivus, Pulsatilla, Sabal serrulata, Selenium metallicum, Sepia, Staphysagria, Thuja occidentalis, LIQUID ORAL 20110120 UNAPPROVED HOMEOPATHIC Apotheca Company CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; PULSATILLA VULGARIS; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0595_d3471a2c-00f3-40a1-9109-d01c83d1ab6b 57520-0595 HUMAN OTC DRUG Water X Betula pendula, cortex, Lappa major, Plantago major, Taraxacum officinale, CAPSULE ORAL 20110125 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTIUM LAPPA ROOT; BETULA PENDULA BARK; PLANTAGO MAJOR; TARAXACUM OFFICINALE 4; 4; 4; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0596_90e5f238-3926-4ea7-b8fd-b89a3a81fe80 57520-0596 HUMAN OTC DRUG Lymphdrainex Geranium robertianum, Nasturtium aquaticum, Aloe socotrina, Juglans regia, Myosotis arvensis, Scrophularia nodosa, Teucrium scorodonia, Apis mellifica, Equisetum hyemale, LIQUID ORAL 20110131 UNAPPROVED HOMEOPATHIC Apotheca Company ALOE; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; CALCIUM SULFIDE; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FLOWERING TOP; MERCURIC CYANIDE; MYOSOTIS ARVENSIS; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; RORIPPA NASTURTIUM-AQUATICUM; SARSAPARILLA ROOT; SCROPHULARIA NODOSA; SODIUM SULFATE; SUS SCROFA PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; SUS SCROFA THYMUS; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 12; 4; 12; 8; 8; 4; 12; 4; 5; 4; 6; 8; 6; 4; 4; 4; 6; 6; 4; 12; 12; 12; 12; 6; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0597_7b959a05-514f-43b3-aa9a-4d145837d3d2 57520-0597 HUMAN OTC DRUG Lymphdrainex Geranium robertianum, Nasturtium aquaticum, Aloe socotrina, Juglans regia, Myosotis arvensis, Scrophularia nodosa, Teucrium scorodonia, Apis mellifica, Equisetum hyemale, Fumaria officinalis, Natrum s LIQUID ORAL 20110131 UNAPPROVED HOMEOPATHIC Apotheca Company ALOE; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; CALCIUM SULFIDE; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FLOWERING TOP; MERCURIC CYANIDE; MYOSOTIS ARVENSIS; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; RORIPPA NASTURTIUM-AQUATICUM; SARSAPARILLA ROOT; SCROPHULARIA NODOSA; SODIUM SULFATE; SUS SCROFA PARATHYROID GLAND; SUS SCROFA THYMUS; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 12; 4; 12; 8; 8; 4; 12; 4; 5; 4; 6; 8; 6; 4; 4; 4; 6; 6; 4; 12; 12; 12; 6; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0598_cce09d45-8564-4996-b701-c5d282a8873b 57520-0598 HUMAN OTC DRUG VestalCare Spot Free Psoriasis Calcarea silicata, Lithium carbonicum, Natrum muriaticum, Phytolacca decandra, Sarsaparilla, Sulphur iodatum, Thyroidinum, TABLET ORAL 20110225 UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM SILICATE; LITHIUM CARBONATE; PHYTOLACCA AMERICANA ROOT; SARSAPARILLA ROOT; SODIUM CHLORIDE; SULFUR IODIDE; THYROID 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57520-0599_485eb959-3ca6-4ced-83ad-065fd8929611 57520-0599 HUMAN OTC DRUG Bio Minulus Mimulus, LIQUID ORAL 20110131 UNAPPROVED HOMEOPATHIC Apotheca Company MIMULUS GUTTATUS FLOWERING TOP 200 [hp_C]/mL 57520-0600_5b8e0e3b-bb6a-4cbb-9d15-58e33049eaca 57520-0600 HUMAN OTC DRUG RheumatismHP Bryonia, Colchicum autumnale, Kalmia latifolia, Ledum palustre, Lycopodium clavatum, Rhododendron chrysanthum, Rhus toxicodendron, LIQUID ORAL 20110131 UNAPPROVED HOMEOPATHIC Apotheca Company BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0603_ff7fae0c-1a0f-4798-9fc9-4e132e771936 57520-0603 HUMAN OTC DRUG Colic Beta vulgaris, Carduus marianus, Lappa major, Aluminium metallicum, Arsenicum album, Chelidonium majus, Hydrastis canadensis, Lycopodium clavatum, Natrum sulphuricum, Nux vomica, Phosphorus, LIQUID ORAL 20110128 UNAPPROVED HOMEOPATHIC Apotheca Company ALUMINUM; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; BETA VULGARIS; CHELIDONIUM MAJUS; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED 12; 3; 12; 3; 12; 12; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0604_8daf924a-3671-4cfa-b445-566946429aa9 57520-0604 HUMAN OTC DRUG HGH Hepar, Human growth hormone, Pituitarum, LIQUID ORAL 20110217 UNAPPROVED HOMEOPATHIC Apotheca Company PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0605_d387ab15-19e3-49c7-ba5e-ac2d575973cf 57520-0605 HUMAN OTC DRUG Pancreaforce Juniperus virginiana, Lappa major, Rhamnus purshiana, Syzygium jambolanum, Chelidonium majus, Lycopodium clavatum, Myrtus communis, Natrum sulphuricum, Phosphoricum acidum, Phosphorus, Tarentula cuben LIQUID ORAL 20110126 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTIUM LAPPA ROOT; CHELIDONIUM MAJUS; CITHARACANTHUS SPINICRUS; FRANGULA PURSHIANA BARK; JUNIPERUS VIRGINIANA TWIG; LYCOPODIUM CLAVATUM SPORE; MYRTUS COMMUNIS TOP; PHOSPHORIC ACID; PHOSPHORUS; SODIUM SULFATE; SYZYGIUM CUMINI SEED 3; 12; 12; 3; 3; 12; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0606_02325dea-fa0d-45e3-8e44-705f7244cf1f 57520-0606 HUMAN OTC DRUG Bio Rock Water Rock Water, LIQUID ORAL 20110204 UNAPPROVED HOMEOPATHIC Apotheca Company HELIANTHEMUM NUMMULARIUM FLOWER 200 [hp_C]/mL 57520-0607_ae27a933-c19a-407d-8951-947a3999c39f 57520-0607 HUMAN OTC DRUG Headache Melilotus officinalis, Spigelia anthelmia, Allium cepa, Belladonna, Bryonia, Cimicifuga racemosa, Gelsemium sempervirens, Glonoinum, Magnesia phosphorica, Nux vomica, LIQUID ORAL 20110203 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; CITHARACANTHUS SPINICRUS; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MELILOTUS OFFICINALIS TOP; NITROGLYCERIN; ONION; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0608_3219ad04-cd61-4407-8c0e-6fb22b7fbe5b 57520-0608 HUMAN OTC DRUG Homeopathic HCG Formula Cyanocobalamin, L-carnitine, Ornithine, Human chorionic gonadotropin, LIQUID ORAL 20110217 UNAPPROVED HOMEOPATHIC Apotheca Company CYANOCOBALAMIN; HUMAN CHORIONIC GONADOTROPIN; LEVOCARNITINE; ORNITHINE 6; 60; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0609_d3d6a880-92a5-4ee4-84f7-0f177e2b9873 57520-0609 HUMAN OTC DRUG hCG Formula Foeniculum vulgare, Fucus vesiculosus, Lecithin, Ammonium carbonicum, Caulophyllum thalictroides, Galium aparine, Lac defloratum, Phosphorus, Phytolacca decandra, Rubus idaeus, SPRAY ORAL 20110208 UNAPPROVED HOMEOPATHIC Apotheca Company AMMONIUM BROMIDE; AMMONIUM CARBONATE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CHLORIDE DIHYDRATE; CALCIUM ARSENATE; CAULOPHYLLUM THALICTROIDES ROOT; CLAVICEPS PURPUREA SCLEROTIUM; FENNEL SEED; FUCUS VESICULOSUS; GALIUM APARINE; HELLEBORUS NIGER ROOT; HUMAN CHORIONIC GONADOTROPIN; LECITHIN, SOYBEAN; LYCOPODIUM CLAVATUM SPORE; MANGANESE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; RUBUS IDAEUS LEAF; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SKIM MILK; STRYCHNOS IGNATII SEED; SUS SCROFA THYMUS; SUS SCROFA THYROID; TRIBASIC CALCIUM PHOSPHATE 8; 6; 8; 30; 30; 30; 8; 6; 30; 2; 3; 6; 30; 60; 3; 30; 8; 30; 30; 6; 6; 6; 30; 30; 6; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0610_cf562505-3afe-4c59-8775-2d9c347167fc 57520-0610 HUMAN OTC DRUG Leg Cramp Relief Magnesia phosphorica, Cuprum metallicum, Colocynthis, Phytolacca decandra, Veratrum album, Causticum, Stannum metallicum, Rhus toxicodendron, TABLET ORAL 20110223 UNAPPROVED HOMEOPATHIC Apotheca Company CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; TIN; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57520-0611_627969d3-a40e-4e97-8fbe-5f03cb3fba83 57520-0611 HUMAN OTC DRUG Insomnia Plus Arsenicum album, Coffea cruda, Kali carbonicum, Magnesia carbonica, Nux vomica, Passiflora incarnata, Sepia, Valeriana officinalis, LIQUID ORAL 20110610 UNAPPROVED HOMEOPATHIC Apotheca Company ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; MAGNESIUM CARBONATE; PASSIFLORA INCARNATA TOP; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0612_ec231637-a608-48b5-9aef-8f8ca4d667e7 57520-0612 HUMAN OTC DRUG Scrofularoforce Juniperus virginiana, Rumex crispus, Scrophularia nodosa, Xanthoxylum fraxineum, Lymph node, Baryta carbonica, Baryta muriatica, Belladonna, Calcarea carbonica, LIQUID ORAL 20110214 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CONIUM MACULATUM FLOWERING TOP; HELLEBORUS NIGER ROOT; IODINE; JUNIPERUS VIRGINIANA TWIG; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM PHOSPHATE, DIBASIC; RUMEX CRISPUS ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE; SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SUS SCROFA LYMPH; ZANTHOXYLUM AMERICANUM BARK 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 3; 3; 12; 12; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0613_98777dfe-1808-4c4e-88ce-a625fc645659 57520-0613 HUMAN OTC DRUG Metabolism Berberis vulgaris, Glycyrrhiza glabra, Lappa major, Rhamnus purshiana, Trifolium pratense, Xanthoxylum fraxineum, Ascorbic acid, Cyanocobalamin, Riboflavinum, Thiaminum hydrochloricum, German sesquiox LIQUID ORAL 20110610 UNAPPROVED HOMEOPATHIC Apotheca Company .ALPHA.-KETOGLUTARIC ACID; ADENOSINE TRIPHOSPHATE; ARCTIUM LAPPA ROOT; ASCORBIC ACID; BERBERIS VULGARIS FRUIT; CALCIUM SULFIDE; CYANOCOBALAMIN; CYSTEINE; FRANGULA PURSHIANA BARK; FUMARIC ACID; GERMANIUM SESQUIOXIDE; GLYCYRRHIZA GLABRA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE GLUCONATE; PULSATILLA VULGARIS; PYRUVIC ACID; RIBOFLAVIN; SODIUM DIETHYL OXALACETATE; THIAMINE HYDROCHLORIDE; TRIFOLIUM PRATENSE FLOWER; UBIDECARENONE; ZANTHOXYLUM AMERICANUM BARK 12; 12; 3; 6; 3; 30; 6; 9; 3; 12; 8; 3; 12; 10; 12; 12; 6; 12; 6; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0614_1f829e1b-1def-47a7-93bf-1e49f29dd0d8 57520-0614 HUMAN OTC DRUG Mag Phos Magnesia phosphorica, PELLET ORAL 20110623 UNAPPROVED HOMEOPATHIC Apotheca Company MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X]/g 57520-0615_ef9158a2-df6c-4c03-9909-b524a0bdc12b 57520-0615 HUMAN OTC DRUG Nicotinum Nicotinum, LIQUID ORAL 20110317 UNAPPROVED HOMEOPATHIC Apotheca Company NICOTINE 6 [hp_X]/mL 57520-0618_62c3e794-4421-4bc1-8b72-3ad9eefa26c8 57520-0618 HUMAN OTC DRUG Back and Neck Rescue Hypericum perforatum, Phytolacca decandra, Guaiacum, Ledum palustre, Conium maculatum, GEL TOPICAL 20111021 UNAPPROVED HOMEOPATHIC Apotheca Company CONIUM MACULATUM FLOWERING TOP; GUAIACUM OFFICINALE RESIN; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT 30; 6; 3; 6; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0620_2e4690dd-2e09-4765-8f3b-6ef237b7e336 57520-0620 HUMAN OTC DRUG Belladonna Belladonna, PELLET ORAL 20110623 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA 12 [hp_X]/g 57520-0621_49621ee7-1b8f-421d-9ac2-423f9bcabda6 57520-0621 HUMAN OTC DRUG Tendon Rescue Bryonia , Ruta graveolens, Bellis perennis, Argentum metallicum, GEL TOPICAL 20111024 UNAPPROVED HOMEOPATHIC Apotheca Company BELLIS PERENNIS; BRYONIA ALBA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILVER 6; 3; 3; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0623_236b803d-bb04-4c52-99ba-237a7a566ae0 57520-0623 HUMAN OTC DRUG Chamomilla Chamomilla, PELLET ORAL 20110621 UNAPPROVED HOMEOPATHIC Apotheca Company CHAMOMILE 12 [hp_X]/g 57520-0624_ce6cb639-d12e-4880-a19b-ad2f75d8202a 57520-0624 HUMAN OTC DRUG Gelsemium Gelsemium sempervirens, PELLET ORAL 20110623 UNAPPROVED HOMEOPATHIC Apotheca Company GELSEMIUM SEMPERVIRENS ROOT 12 [hp_X]/g 57520-0625_d8ec7d5d-a1e9-4c9f-b978-851688ec1b33 57520-0625 HUMAN OTC DRUG Ignatia Emotional Stress Ignatia amara, PELLET ORAL 20110623 UNAPPROVED HOMEOPATHIC Apotheca Company STRYCHNOS IGNATII SEED 12 [hp_X]/g 57520-0626_b6619b24-f973-4c1e-a529-3b03be199b97 57520-0626 HUMAN OTC DRUG Ipecac Ipecacuanha, PELLET ORAL 20110621 UNAPPROVED HOMEOPATHIC Apotheca Company IPECAC 12 [hp_X]/g 57520-0628_e311bbb1-0dde-4d27-9c34-0403e00ed085 57520-0628 HUMAN OTC DRUG Muscle Ice Phytolacca decandra, Symphytum officinale, Bellis perennis, Ledum palustre, Ruta graveolens, Magnesia phosphorica, Silicea, GEL TOPICAL 20111024 UNAPPROVED HOMEOPATHIC Apotheca Company BELLIS PERENNIS; COMFREY ROOT; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE 6; 3; 6; 9; 1; 6; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0629_b7735057-75ab-4ef6-a443-9f94adfdd285 57520-0629 HUMAN OTC DRUG Pulsatilla Pulsatilla, PELLET ORAL 20110623 UNAPPROVED HOMEOPATHIC Apotheca Company PULSATILLA VULGARIS 12 [hp_X]/g 57520-0630_01c74b2c-525e-44aa-bbd3-68a0ce135c64 57520-0630 HUMAN OTC DRUG Arnica Plus Arnica montana, Hamamelis virginiana, Rhus toxicodendron, GEL TOPICAL 20111020 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0632_a93042a6-ba5a-4c6e-8ac9-c1f6f9e16c13 57520-0632 HUMAN OTC DRUG Candida Candida albicans, LIQUID ORAL 20110211 UNAPPROVED HOMEOPATHIC Apotheca Company CANDIDA ALBICANS 30 [hp_C]/mL 57520-0633_b6acb030-5212-4aec-a9d4-088d1cd78270 57520-0633 HUMAN OTC DRUG HZ HP Lycopodium clavatum, Natrum muriaticum, Nitricum acidum, Ranunculus bulbosus, Rhus toxicodendron, Sepia, Thuja occidenalis, LIQUID ORAL 20110211 UNAPPROVED HOMEOPATHIC Apotheca Company LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0634_88c61bae-4915-4af0-bfe5-2f435998481a 57520-0634 HUMAN OTC DRUG Colloidal Silver Colloidal silver, LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Apotheca Company SILVER 12 [hp_X]/mL 57520-0635_30989d1c-fcdc-4e59-a243-e48886c6ecd2 57520-0635 HUMAN OTC DRUG Leg Cramp Relief Causticum, Colocynthis, Cuprum metallicum, Magnesia phosphorica, Phytolacca decandra, Rhus toxicodendron, Stannum metallicum, Veratrum album, TABLET ORAL 20110606 UNAPPROVED HOMEOPATHIC Apotheca Company CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; TIN; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57520-0636_92a7ba30-b54c-4446-88c9-f0c946a5e85d 57520-0636 HUMAN OTC DRUG Bio Pine Pine, LIQUID ORAL 20110225 UNAPPROVED HOMEOPATHIC Apotheca Company PINUS SYLVESTRIS FLOWERING TOP 200 [hp_C]/mL 57520-0637_da8e0b11-fa2d-4a48-a916-e92ca61aea26 57520-0637 HUMAN OTC DRUG Endopure Testos for Men DNA, RNA, Cortisol, Glandula suprarenalis, Hypothalamus, Pituitary, Prostate, Testosterone, Chelidonium majus, Sabal serrulata, Thuja occidentalis, LIQUID ORAL 20110316 UNAPPROVED HOMEOPATHIC Apotheca Company CHELIDONIUM MAJUS; HERRING SPERM DNA; HYDROCORTISONE; SACCHAROMYCES CEREVISIAE RNA; SAW PALMETTO; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; TESTOSTERONE; THUJA OCCIDENTALIS LEAFY TWIG 12; 6; 6; 6; 12; 6; 6; 6; 6; 12; 30 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0638_d23d7d2c-5a16-43b6-afd6-985b54cbc3f0 57520-0638 HUMAN OTC DRUG Testosterone Testosterone, TABLET ORAL 20110607 UNAPPROVED HOMEOPATHIC Apotheca Company TESTOSTERONE 30 [hp_X]/1 57520-0639_14864dd4-c0a1-4ab8-a9b2-348d36fd5309 57520-0639 HUMAN OTC DRUG Dr Cs Weight Maintenance Chelidonium majus, Fucus vesiculosus, Cyanocobalamin, Spongia tosta, Thea sinensis, Calcarea phosphorica, Calcarea fluorica, Kali phosphoricum, Natrum sulphuricum, Pulsatilla, Lycopodium clavatum, Cal LIQUID ORAL 20110715 UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM FLUORIDE; CHELIDONIUM MAJUS; CYANOCOBALAMIN; FUCUS VESICULOSUS; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; SULFUR; TEA LEAF OIL; TRIBASIC CALCIUM PHOSPHATE 12; 6; 6; 6; 30; 30; 30; 12; 12; 12; 6; 30; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0640_c00718cc-3010-4db6-b75f-0da4e88c1b83 57520-0640 HUMAN OTC DRUG Melatonin Forte Melatonin, Nadidum, Niacin, Pyridoxinum hydrochloricum, Zincum sulphuricum, Hypothalamus, Lithium carbonicum, Magnesia carbonica, Pineal, Pituitary, SPRAY ORAL 20110818 UNAPPROVED HOMEOPATHIC Apotheca Company BOS TAURUS HYPOTHALAMUS; LITHIUM CARBONATE; MAGNESIUM CARBONATE; MELATONIN; NADIDE; NIACIN; PYRIDOXINE HYDROCHLORIDE; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; ZINC SULFATE HEPTAHYDRATE 8; 8; 8; 6; 6; 6; 6; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0642_4d68681b-9688-45b2-acdd-e1656ad685e6 57520-0642 HUMAN OTC DRUG Multi Flower Agrimony, Aspen, Beech, Centaury, Cerato, Cherry Plum, Chestnut bud, Chicory, Clematis, Crab apple, Elm, Gentian, Gorse, Heather, Holly, LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Apotheca Company AESCULUS CARNEA FLOWER; AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWERING TOP; BROMUS RAMOSUS FLOWER; CALLUNA VULGARIS FLOWERING TOP; CARPINUS BETULUS FLOWER; CASTANEA SATIVA FLOWER; CENTAURIUM ERYTHRAEA FLOWER; CERATOSTIGMA WILLMOTTIANUM FLOWER; CICHORIUM INTYBUS FLOWER; CLEMATIS VITALBA FLOWER; FAGUS SYLVATICA FLOWERING TOP; GENTIANELLA AMARELLA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; IMPATIENS GLANDULIFERA FLOWER; LARIX DECIDUA FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWER; MALUS SYLVESTRIS FLOWER; MIMULUS GUTTATUS FLOWERING TOP; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM; PINUS SYLVESTRIS FLOWERING TOP; POPULUS TREMULA FLOWERING TOP; PRUNUS CERASIFERA FLOWER; QUERCUS ROBUR FLOWER; ROSA CANINA FLOWER; SALIX ALBA FLOWERING TOP; SCLERANTHUS ANNUUS FLOWERING TOP; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; ULEX EUROPAEUS FLOWER; ULMUS PROCERA FLOWERING TWIG; VERBENA OFFICINALIS FLOWERING TOP; VITIS VINIFERA FLOWERING TOP; WATER 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0643_3cb092b0-440a-43bb-ac0c-9aa272b8540f 57520-0643 HUMAN OTC DRUG Rescue 5 Cherry plum, Clematis, Impatiens, Rock rose, Star of bethlehem, LIQUID ORAL 20110302 UNAPPROVED HOMEOPATHIC Apotheca Company CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER 30; 30; 30; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0644_d8e0ad5f-2735-4737-8b8d-4386fc3eeda9 57520-0644 HUMAN OTC DRUG Renstat Berberis vulgaris, Uva ursi, Sabal serrulata, Petroselinum sativum, Cantharis, Mercurius corrosivus, Solidago virgaurea, Sarsaparilla, Lithium carbonicum, Pareire brava, LIQUID ORAL 20110302 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; CHONDRODENDRON TOMENTOSUM ROOT; LITHIUM CARBONATE; LYTTA VESICATORIA; MERCURIC CHLORIDE; PETROSELINUM CRISPUM; SARSAPARILLA ROOT; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP 3; 3; 12; 12; 12; 12; 3; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0645_eaac4da6-2987-4d11-92e7-b37f578b0797 57520-0645 HUMAN OTC DRUG Platinum for Men Cyanocobalamin, Glandula suprarenalis suis, Kali carbonicum, L-carnitine, L-glutamine, L-ornithine, L-tryptophan, L-tyrosine, Orchitinum. LIQUID ORAL 20110303 UNAPPROVED HOMEOPATHIC Apotheca Company CARNITINE; CYANOCOBALAMIN; GLUTAMINE; HUMAN CHORIONIC GONADOTROPIN; LYCOPODIUM CLAVATUM SPORE; ORNITHINE; POTASSIUM CARBONATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA TESTICLE; SUS SCROFA THYROID; TRYPTOPHAN; TYROSINE 6; 6; 6; 60; 10; 6; 6; 6; 6; 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0646_d5abf2e7-2d35-405c-8e6a-f20fe1c5a867 57520-0646 HUMAN OTC DRUG Gold L-carnitine, L-glutamine, L-ornithine, L-tryptophan, L-tyrosine, Human chorionic gonadotropin, LIQUID ORAL 20110303 UNAPPROVED HOMEOPATHIC Apotheca Company CARNITINE; GLUTAMINE; HUMAN CHORIONIC GONADOTROPIN; ORNITHINE; TRYPTOPHAN; TYROSINE 6; 6; 60; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0647_cff86752-795b-479e-bb47-212a2e09654a 57520-0647 HUMAN OTC DRUG Platinum for Women Cyanocobalamin, Glandula suprarenalis suis, Kali carbonicum, L-carnitine, L-glutamine, L -ornithine, L-tryptophan, L-tyrosine, LIQUID ORAL 20110307 UNAPPROVED HOMEOPATHIC Apotheca Company CYANOCOBALAMIN; GLUTAMINE; HUMAN CHORIONIC GONADOTROPIN; LEVOCARNITINE; ORNITHINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; SUS SCROFA THYROID; TRYPTOPHAN; TYROSINE 6; 6; 60; 6; 6; 12; 6; 6; 6; 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0648_9da92979-e839-4eee-a1f6-5038bde81461 57520-0648 HUMAN OTC DRUG Triple Potency HGH Hepar, Human growth hormone, Pituitarum, SPRAY ORAL 20110329 UNAPPROVED HOMEOPATHIC Apotheca Company PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0651_f60c267a-5ed2-445d-a920-53d9a133204f 57520-0651 HUMAN OTC DRUG Allergy Rescue 1 Allium cepa, Ambrosia artemisiaefolia, Apis mellifica, Arsenicum album, Euphrasia officinalis, Nux vomica, Phosphorus, Pulsatilla, Solidago virgaurea, Sulphur, LIQUID ORAL 20110407 UNAPPROVED HOMEOPATHIC Apotheca Company AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0652_ad3559fd-b3d6-4ecb-a88e-5bf112abbe50 57520-0652 HUMAN OTC DRUG Allergy Rescue 2 Chelidonium majus, Echinacea, Gentiana lutea, Arsenicum album, Carbo vegetalilis, Lycopodium clavatum, Nux vomica, Phosphorus, Pulsatilla, LIQUID ORAL 20110330 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; CHELIDONIUM MAJUS; ECHINACEA; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED 12; 12; 3; 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0653_71f8568e-8431-4cea-9a60-fe32f5d458fa 57520-0653 HUMAN OTC DRUG Allergy Rescue 3 Baptisia tinctoria, Echinacea, Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Euphrasia officinalis, Natrum sulphuricum, Nux vomica, Phosphorus, Pulsatilla, Solidago virgaurea, Sulphur, LIQUID ORAL 20110331 UNAPPROVED HOMEOPATHIC Apotheca Company AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ECHINACEA; EUPHRASIA STRICTA; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0654_782a5fd1-1b9d-462e-9317-0a793ee77128 57520-0654 HUMAN OTC DRUG Sinus Rescue 1 Arsenicum album, Hepar sulphuris calcareum, Hydrastis canadensis, Kali bichromicum, Lycopodium clavatum, Mercurius solubilis, Natrum muriaticum, Phosphorus, Pulsatilla, Sepia, Thuja occidentalis, LIQUID ORAL 20110331 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; CALCIUM SULFIDE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0655_0e0802ba-ab8e-4349-a180-95461c427ade 57520-0655 HUMAN OTC DRUG Sinus Rescue 2 Echinacea, Hydrastis canadensis, Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Kali bichromicum, Nux moschata, Pulsatilla, Sepia, Solidago virgaurea, LIQUID ORAL 20110330 UNAPPROVED HOMEOPATHIC Apotheca Company AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; ECHINACEA; GOLDENSEAL; NUTMEG; ONION; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SOLIDAGO VIRGAUREA FLOWERING TOP 12; 12; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0656_06ba3f44-3685-40aa-b49d-a9164613e832 57520-0656 HUMAN OTC DRUG Bacteriostat Baptisia tinctoria, Echinacea, Phytolacca decandra, Aconitum napellus, Arsenicum album, Belladonna, Ferrum phosphoricum, Lachesis mutus, Phosphorus, LIQUID ORAL 20110330 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; ECHINACEA; FERRUM PHOSPHORICUM; LACHESIS MUTA VENOM; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT 12; 12; 12; 3; 3; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0657_a9a21507-d564-4f36-8745-63e77f473978 57520-0657 HUMAN OTC DRUG Virostat Echinacea, Hydrastis canadensis, Lomatium, Aconitum napellus, Arsenicum album, Belladonna, Eupatorium perfoliatum, Gelsemium sempervirens, Lachesis mutus, Rhus toxicodendron, Pyrogenium, LIQUID ORAL 20110330 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; LOMATIUM DISSECTUM ROOT; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3; 12; 3; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0659_f7082951-8818-47f2-ab7e-c88844135757 57520-0659 HUMAN OTC DRUG Bio Cherry Plum Cherry plum, LIQUID ORAL 20110316 UNAPPROVED HOMEOPATHIC Apotheca Company PRUNUS CERASIFERA FLOWER 200 [hp_C]/mL 57520-0660_3c540ecc-eb30-43b7-bfac-2f43ee5d1544 57520-0660 HUMAN OTC DRUG Optimal Diet Plan Fucus vesiculosus, Cyanocobalamin, Glandula suprarenalis, Hepar suis, L-carnitine, L-ornithine, Antimonium crudum, Thyroidinum, Natrum sulphuricum, Pancreatinum, Hypothalamus, LIQUID ORAL 20110513 20160411 UNAPPROVED HOMEOPATHIC Apotheca Company ANTIMONY TRISULFIDE; BOS TAURUS HYPOTHALAMUS; CARNITINE; CYANOCOBALAMIN; FUCUS VESICULOSUS; ORNITHINE; PANCRELIPASE; PORK LIVER; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; THYROID 8; 18; 30; 6; 2; 30; 12; 6; 10; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0661_e1f6cec1-6bf3-40e0-8f60-21b370b10dce 57520-0661 HUMAN OTC DRUG Flu Rescue Baptisia tinctoria, Echinacea, Hydrastis canadensis, Phytolacca decandra, Arsenicum album, Bryonia, Eupatorium perfoliatum, Ferrum phosphoricum, LIQUID ORAL 20110405 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; IPECAC; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF 12; 3; 12; 3; 12; 12; 12; 3; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0662_3f451e6f-56ce-49fa-bd5f-f415d8970608 57520-0662 HUMAN OTC DRUG Infect Rescue Aconitum napellus, Arsenicum album, Baptisia tinctoria, Belladonna, Bryonia, Causticum, Echinacea, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Hydrastis canadensis, LIQUID ORAL 20110401 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAUSTICUM; COMFREY ROOT; DEFIBROTIDE (BOVINE LUNG); ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; SODIUM SULFATE; SULFUR; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0663_401b45b7-2f40-43fe-970d-96c5842f4f43 57520-0663 HUMAN OTC DRUG Flutone Baptisia tinctoria, Echinacea, Hydrastis canadensis, Phytolacca decandra, Arsenicum album, Bryonia, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Ipecacuanha, Rhus toxicodendron LIQUID ORAL 20110318 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; IPECAC; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF 12; 3; 12; 3; 12; 12; 12; 3; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0667_626c0d6b-c4f5-4317-af86-d4e1a454c22c 57520-0667 HUMAN OTC DRUG DV HP Calcarea carbonica, Chenopodium anthelminticum, Cocculus indicus, Conium maculatum, Nux Vomica, Phosphorus, Pulsatilla, Silicea, LIQUID ORAL 20110411 UNAPPROVED HOMEOPATHIC Apotheca Company ANAMIRTA COCCULUS SEED; CHENOPODIUM AMBROSIOIDES; CONIUM MACULATUM FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0669_55073774-dde9-490f-83eb-03a3decfda2f 57520-0669 HUMAN OTC DRUG Bio Centaury Centaury, LIQUID ORAL 20110412 UNAPPROVED HOMEOPATHIC Apotheca Company CENTAURIUM ERYTHRAEA FLOWER 200 [hp_C]/mL 57520-0670_23bc0b01-4b43-4b88-9d47-937393ba719a 57520-0670 HUMAN OTC DRUG Bio Hornbeam Hornbeam LIQUID ORAL 20110407 UNAPPROVED HOMEOPATHIC Apotheca Company CARPINUS BETULUS FLOWER 200 [hp_C]/mL 57520-0672_4272dbf4-00c8-4fa0-8b6d-3b41501f8a86 57520-0672 HUMAN OTC DRUG Bio Electrolyte Boricum gluconicum, Calcarea gluconica, Chromium gluconicum, Cobaltum gluconicum, Cuprum gluconicum, Ferrum gluconicum, Kali gluconicum, Magnesia gluconica, Manganum gluconicum, Natrum gluconicum, Nic LIQUID ORAL 20110420 UNAPPROVED HOMEOPATHIC Apotheca Company BORON GLUCONATE; CALCIUM GLUCONATE; CHROMIUM GLUCONATE; COBALTOUS GLUCONATE; COPPER GLUCONATE; FERROUS GLUCONATE; MAGNESIUM GLUCONATE; MANGANESE GLUCONATE; NICKEL GLUCONATE; POTASSIUM GLUCONATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM DIOXIDE; SODIUM GLUCONATE; TRIBASIC CALCIUM PHOSPHATE; VANADIUM; ZINC GLUCONATE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 6; 6; 9; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0675_85627e48-e2ff-4a16-a5a5-44320a259b40 57520-0675 HUMAN OTC DRUG Virustat Echinacea, Hydrastit canadensis, Lomatium, Aconitum napellus, Arsenicum album, Belladonna, Eupatorium perfoliatum, Gelsemium sempervirens, Lachesis mutus, Rhus toxicodendron, Pyrogenium, LIQUID ORAL 20110413 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; LOMATIUM DISSECTUM ROOT; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3; 12; 3; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0676_ad79bd54-bfdf-4856-9c26-c0ae1987f29a 57520-0676 HUMAN OTC DRUG Fucus Vesiculosus Fucus vesiculosus, LIQUID ORAL 20110411 UNAPPROVED HOMEOPATHIC Apotheca Company FUCUS VESICULOSUS 30 [hp_C]/mL 57520-0677_90582206-0a8e-421e-9c1c-364461540168 57520-0677 HUMAN OTC DRUG Cesium Chloride Cesium chloride LIQUID ORAL 20110414 UNAPPROVED HOMEOPATHIC Apotheca Company CESIUM CHLORIDE 6 [hp_X]/mL 57520-0684_c23d41be-892e-4002-90e2-2d65798b8c7f 57520-0684 HUMAN OTC DRUG Grippe HP Aconitum napellus, Arsenicum album, Baptisia tinctoris, Belladonna, Bryonia, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, LIQUID ORAL 20110428 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0685_faad6f8c-738c-4423-91d8-7236eaea1168 57520-0685 HUMAN OTC DRUG Bio Honeysuckle Honeysuckle, LIQUID ORAL 20110428 UNAPPROVED HOMEOPATHIC Apotheca Company LONICERA CAPRIFOLIUM FLOWER 200 [hp_C]/mL 57520-0686_5cc8d822-da65-49fb-ba90-915b7a11eebc 57520-0686 HUMAN OTC DRUG Bio Vine Vine, LIQUID ORAL 20110428 UNAPPROVED HOMEOPATHIC Apotheca Company VITIS VINIFERA FLOWERING TOP 200 [hp_C]/mL 57520-0691_8aeaaaa4-fb4c-4006-8a9f-eeadc4848210 57520-0691 HUMAN OTC DRUG Optimal HCG Diet Plan Fucus vesiculosus, Cyanocobalamin, Glandula suprarenalis suis, Hepar suis, L-carnitine, L-ornithine, Antimonium crudum, Thyroidinum suis, LIQUID ORAL 20130326 20160726 UNAPPROVED HOMEOPATHIC Apotheca Company ANTIMONY TRISULFIDE; CYANOCOBALAMIN; FUCUS VESICULOSUS; LEVOCARNITINE; ORNITHINE; PANCRELIPASE; PORK LIVER; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA THYROID 8; 6; 2; 30; 30; 12; 6; 10; 6; 18; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0695_30fd886c-f605-4121-8d58-f8ccc933691b 57520-0695 HUMAN OTC DRUG Neuroforce Echinacea, Hypericum perforatum, Symphytum officinale, Arnica montana, Agaricus muscarius, Arsenicum album, Gelsemium sempervirens, Plumbum metallicum, Rhus toxicodendron, LIQUID ORAL 20110519 UNAPPROVED HOMEOPATHIC Apotheca Company AMANITA MUSCARIA VAR. MUSCARIA; ARNICA MONTANA; ARSENIC TRIOXIDE; COMFREY ROOT; ECHINACEA; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; LEAD; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 3; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0696_fc4e521a-e12b-4f57-b321-eb60f93f3fb3 57520-0696 HUMAN OTC DRUG Pollen Mix Goldenrod, Red clover, Alfalfa, Sheep sorrel, Yellow dock, Kentucky bluegrass, Orchard grass, Redtop grass, Timothy grass, Giant ragweed, False ragweed, Short ragweed, LIQUID ORAL 20110613 UNAPPROVED HOMEOPATHIC Apotheca Company ACER NEGUNDO POLLEN; AGROSTIS GIGANTEA POLLEN; ALFALFA; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; BETULA OCCIDENTALIS POLLEN; CARYA OVATA POLLEN; DACTYLIS GLOMERATA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS VELUTINA POLLEN; JUGLANS NIGRA POLLEN; PHLEUM PRATENSE POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS RUBRA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SOLIDAGO CANADENSIS POLLEN; TRIFOLIUM PRATENSE POLLEN; ULMUS AMERICANA POLLEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0700_6d184d71-8486-4f20-8f27-5508b1baef9f 57520-0700 HUMAN OTC DRUG Arterioforce I Arnica montana, Lilium tigrinum, Aurum muriaticum, Cactus grandiflorus, Digitalis purpurea, Glonoinum, Nux vomica, Veratrum album, LIQUID ORAL 20110511 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; DIGITALIS; GOLD TRICHLORIDE; LILIUM LANCIFOLIUM BULB; NITROGLYCERIN; SELENICEREUS GRANDIFLORUS STEM; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 3; 12; 12; 4; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0701_e148766d-e40d-4464-b0a1-af4e544189f7 57520-0701 HUMAN OTC DRUG Acetylcholine chloride Acetylcholine chloride, LIQUID ORAL 20110518 UNAPPROVED HOMEOPATHIC Apotheca Company ACETYLCHOLINE CHLORIDE 30 [hp_C]/mL 57520-0702_f156f510-b1e8-4be5-b135-e5573fbe86f0 57520-0702 HUMAN OTC DRUG Trauma Free Symphytum officinale, Bellis perennis, Hypericum perforatum, Magnesia phosphorica, Ruta graveolens, Arnica montana, LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BELLIS PERENNIS; COMFREY ROOT; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RUTA GRAVEOLENS FLOWERING TOP 200; 12; 3; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0703_187b89d7-b6fb-4138-8ed0-995c6f0e1c92 57520-0703 HUMAN OTC DRUG NAJA Forte X Naja tripudians, LIQUID ORAL 20110602 UNAPPROVED HOMEOPATHIC Apotheca Company NAJA NAJA VENOM 30 [hp_X]/mL 57520-0704_637717bc-6d10-4524-baff-324f3f0f32ef 57520-0704 HUMAN OTC DRUG Rheumaforce Chondrus crispus, Cimicifuga racemosa, Spiraea ulmaria, Symphytum officinale, Trifolium pratense, Urtica urens, Xanthoxylum fraxineum, Colchicum autumnale, Ferrum phosphoricum, Formica rufa, LIQUID ORAL 20110524 UNAPPROVED HOMEOPATHIC Apotheca Company BLACK COHOSH; CHONDRUS CRISPUS; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; FERRUM PHOSPHORICUM; FILIPENDULA ULMARIA ROOT; FORMICA RUFA; LITHIUM CARBONATE; RHODODENDRON AUREUM LEAF; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; URTICA URENS; ZANTHOXYLUM AMERICANUM BARK 3; 3; 12; 3; 12; 3; 12; 12; 12; 12; 12; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0705_b9df1e34-aee7-4406-9da3-ecb9d28bd937 57520-0705 HUMAN OTC DRUG Sycosis Complex Zincum metallicum, Silicea, Sulphur, Thuja occidentalis, LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Apotheca Company SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 30; 30; 30; 12 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 57520-0708_d39b41e9-a507-4e2f-a339-1ced2a8494c7 57520-0708 HUMAN OTC DRUG Pneumoforce Althaea officinalis, Natrum carbonicum, Rheum officinals, Verbascum thapsus, Zingiber officinale, Aconitum napellus, Drosera rotundifolia, Kali bichromicum, Lobelia inflata, Phosphorus, LIQUID ORAL 20110525 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ALTHAEA OFFICINALIS ROOT; DROSERA ROTUNDIFOLIA; GINGER; LOBELIA INFLATA; PHOSPHORUS; POTASSIUM DICHROMATE; RHEUM OFFICINALE ROOT; SODIUM CARBONATE; VERBASCUM THAPSUS 12; 3; 12; 3; 12; 12; 12; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0710_51a649b9-ef27-4816-a50a-982233340909 57520-0710 HUMAN OTC DRUG Acne Kali bromatum, Natrum bromatum, Niccolum sulphuricum, Sulphur, Hepar suphuris calcareum, TABLET ORAL 20110715 UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM SULFIDE; NICKEL SULFATE HEXAHYDRATE; POTASSIUM BROMIDE; SODIUM BROMIDE; SULFUR 9; 6; 1; 2; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57520-0711_eda9f5bc-1a20-4591-b1c1-3b015952c8db 57520-0711 HUMAN OTC DRUG Acne Kali bromatum, Natrum bromatum, Niccolum sulphuricum, Sulphur, Hepar sulphurs calcareum, TABLET ORAL 20110629 UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM SULFIDE; NICKEL SULFATE HEXAHYDRATE; POTASSIUM BROMIDE; SODIUM BROMIDE; SULFUR 9; 6; 1; 2; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57520-0712_4cefb645-9980-44f7-8e11-794448d38366 57520-0712 HUMAN OTC DRUG Loma Lux Psoriasis Kali bromatum, Natrum sulphuricum, Niccolum Sulphuricum, Kali sulphuricum, Zincum bromatum, LIQUID ORAL 20110705 UNAPPROVED HOMEOPATHIC Apotheca Company NICKEL SULFATE HEXAHYDRATE; POTASSIUM BROMIDE; POTASSIUM SULFATE; SODIUM BROMIDE; ZINC BROMIDE 3; 1; 4; 2; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0713_a4b3c89c-c5f6-4ca7-ad45-72942c86e512 57520-0713 HUMAN OTC DRUG Loma Lux Psoriasis Kali bromatum, Natrum bromatum, Niccolum sulphuricum, Kali sulphuricum, Zincum bromatum, LIQUID ORAL 20110707 UNAPPROVED HOMEOPATHIC Apotheca Company NICKEL SULFATE HEXAHYDRATE; POTASSIUM BROMIDE; POTASSIUM SULFATE; SODIUM BROMIDE; ZINC BROMIDE 3; 1; 4; 2; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0719_24fd40f1-cff3-49b4-a91c-594515b00dfe 57520-0719 HUMAN OTC DRUG Dr Wises Gluten Relief Lycopodium clavatum, Pulsatilla, CAPSULE ORAL 20110614 UNAPPROVED HOMEOPATHIC Apotheca Company LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS 12; 12 [hp_X]/1; [hp_X]/1 57520-0725_f17551b4-fe82-4f07-9af9-b28905b394e4 57520-0725 HUMAN OTC DRUG Epinephrine Adrenalinum, LIQUID ORAL 20110707 UNAPPROVED HOMEOPATHIC Apotheca Company EPINEPHRINE 200 [hp_C]/mL 57520-0726_adfd6a4d-79b0-4264-aeec-8782ca97f4c0 57520-0726 HUMAN OTC DRUG Ileocecal Valve Support Iodium, Pituitarium posterium, Thyroidinum, Glandula suprarenalis suis, Fel tauri, Taraxacum officinale, Bryonia, Carbo vegetabilis, Colocynthis, Indolum, Lycopodium clavatum, Mercurius corrosivus, Nux vomica, Phosphorus, Pulsatilla, LIQUID ORAL 20110706 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; BOS TAURUS BILE; BRYONIA ALBA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; INDOLE; IODINE; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; TARAXACUM OFFICINALE; THYROID, PORCINE 30; 12; 30; 30; 30; 6; 30; 30; 30; 30; 30; 10; 8; 12; 8 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0727_1680744b-22c6-47bf-8e3b-28aa9e483f1d 57520-0727 HUMAN OTC DRUG Bryonia Bryonia, PELLET ORAL 20110623 UNAPPROVED HOMEOPATHIC Apotheca Company BRYONIA ALBA ROOT 12 [hp_X]/g 57520-0729_6f1a558c-d67c-431a-81aa-cdcaa4770f59 57520-0729 HUMAN OTC DRUG Melatonin Melatonin, LIQUID ORAL 20110715 UNAPPROVED HOMEOPATHIC Apotheca Company MELATONIN 200 [hp_C]/mL 57520-0731_f16c19e4-786d-4a9a-b089-73d91e0cfe63 57520-0731 HUMAN OTC DRUG Septaforce Baptisia tinctoria, Echinacea, Arsenicum album, Chininum sulphuricum, Crotalus horridus, Lachesis mutus, Loxosceles reclusa, Secale cornutum, Tarentula cubensis, Latrodectus mactans, Anthracinum, LIQUID ORAL 20110706 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; CITHARACANTHUS SPINICRUS; CLAVICEPS PURPUREA SCLEROTIUM; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; LATRODECTUS MACTANS VENOM; LOXOSCELES RECLUSA; QUININE SULFATE 12; 33; 3; 12; 12; 12; 3; 12; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0735_5bbd0bcc-ced6-4aaa-bf18-1baeba88477e 57520-0735 HUMAN OTC DRUG Gallbladder Liver Meridian Opener Arsenicum album, Berberis vulgaris, Bryonia, Calcarea carbonica, Carduus marianus, Cinchona officinalis, Kali carbonicum, Lycopodium clavatum, Natrum sulphuricum, Nux vomica, Phosphorus, LIQUID ORAL 20110711 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0736_5f0e0566-2539-4880-885d-c945da3b1a7f 57520-0736 HUMAN OTC DRUG Gallic Acid Gallicum acidum, LIQUID ORAL 20110715 UNAPPROVED HOMEOPATHIC Apotheca Company GALLIC ACID MONOHYDRATE 200 [hp_C]/mL 57520-0739_8335259d-1c94-4372-a5a6-36c49ad6adbf 57520-0739 HUMAN OTC DRUG Tyramine Tyramine, LIQUID ORAL 20110728 UNAPPROVED HOMEOPATHIC Apotheca Company TYRAMINE 200 [hp_C]/mL 57520-0740_ff8259f7-2cc1-4467-8f9b-57af2da0b69b 57520-0740 HUMAN OTC DRUG DNA DNA, LIQUID ORAL 20110801 UNAPPROVED HOMEOPATHIC Apotheca Company HERRING SPERM DNA 12 [hp_X]/mL 57520-0755_571b1382-1a64-4460-b29f-2d7df5a6054d 57520-0755 HUMAN OTC DRUG Serotonin Serotonin LIQUID ORAL 20110728 UNAPPROVED HOMEOPATHIC Apotheca Company SEROTONIN 200 [hp_C]/mL 57520-0756_edc177e9-3590-47c0-b26c-43b996579469 57520-0756 HUMAN OTC DRUG Sinusitis Pulsatilla, Plantago major, Euphorbium officinarum, Luffa operculata, Mercurius iodatus ruber, Mucosa nasalis suis, Argentum nitricum, Hepar sulphuris calcareum, Calcarea carbonica, Natrum muriaticum, LIQUID ORAL 20110727 UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM SULFIDE; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILVER NITRATE; SINUSITISINUM; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA 10; 4; 6; 8; 12; 3; 2; 10; 18; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0757_84e65868-3a28-446a-9caf-dc8c781a4d39 57520-0757 HUMAN OTC DRUG Lymph Rx Ceanothus Americanus, Euphrasia Officinalis, Germanium Robertianum, LIQUID ORAL 20110912 UNAPPROVED HOMEOPATHIC Apotheca Company ALTHAEA OFFICINALIS ROOT; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; CEANOTHUS AMERICANUS LEAF; ECHINACEA, UNSPECIFIED; EQUISETUM HYEMALE; EUPHRASIA STRICTA; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FLOWERING TOP; MERCURIC CYANIDE; MYOSOTIS ARVENSIS; PEUMUS BOLDUS LEAF; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM IODIDE; RORIPPA NASTURTIUM-AQUATICUM; SCROPHULARIA NODOSA; SMILAX REGELII ROOT; SODIUM SULFATE; SUS SCROFA PARATHYROID GLAND; SUS SCROFA THYMUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, PORCINE; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP; VISCUM ALBUM FRUITING TOP 1; 4; 12; 8; 8; 1; 3; 1; 1; 4; 1; 8; 1; 1; 1; 1; 8; 1; 1; 3; 1; 1; 3; 1; 1; 4; 12; 12; 1; 1; 12; 8; 4; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0758_48379cba-deac-4a16-aee7-47c91edde5c2 57520-0758 HUMAN OTC DRUG Weed Grass Antigens Allium cepa, Arsenicum album, Nux vomica, Pulsatilla, Alfalfa, Amaranthus, Bamboo, Cocklebur, Dandelion, Goldenrod, Kentucky blue, Lambs quarters, LIQUID ORAL 20110817 UNAPPROVED HOMEOPATHIC Apotheca Company AGRIMONIA EUPATORIA FLOWERING TOP; AGROSTIS GIGANTEA POLLEN; ALFALFA; ALLIUM CEPA WHOLE; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARSENIC TRIOXIDE; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN; BAMBUSA VULGARIS LEAF; CHENOPODIUM ALBUM POLLEN; DACTYLIS GLOMERATA POLLEN; FESTUCA PRATENSIS POLLEN; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; LOLIUM PERENNE POLLEN; OXALIS MONTANA LEAF; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; PULSATILLA VULGARIS; RED CLOVER; RUMEX CRISPUS POLLEN; SOLIDAGO CANADENSIS FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TRIFOLIUM REPENS FLOWER 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0763_44a89ef2-15b3-4b18-9cf8-13cdfba07fb7 57520-0763 HUMAN OTC DRUG Chemtox Berberis vulgaris, Glycyrrhiza glabra, Lappa major, Phytolacca decandra, Stillingia sylvatica, Trifolium pratense, Glandula suprarenalis suis, Hepar suis, Lymph suis, Thyroidinum suis, Belladonna, Iri LIQUID ORAL 20110728 UNAPPROVED HOMEOPATHIC Apotheca Company ACETIC ACID; ARCTIUM LAPPA ROOT; ATROPA BELLADONNA; BENZOIC ACID; BENZYL ALCOHOL; BERBERIS VULGARIS ROOT BARK; BORIC ACID; CHLORINE; CORTICOTROPIN; CORTISONE ACETATE; ESTRONE; EUGENOL; GLYCYRRHIZA GLABRA; IRIDIUM; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LEAD; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PETROLATUM; PHENYLBUTAZONE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PORK LIVER; POTASSIUM SORBATE; RESORCINOL; SALICYLIC ACID; SELENIUM; SORBITOL; STEARYL ALCOHOL; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA THYROID; TRIFOLIUM PRATENSE FLOWER; XYLITOL 200; 3; 12; 200; 200; 3; 200; 200; 200; 200; 200; 200; 3; 12; 200; 200; 200; 12; 12; 200; 200; 12; 3; 8; 200; 200; 200; 12; 200; 200; 3; 12; 8; 8; 8; 3; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0764_60bb8396-c03c-4e68-a189-eab00e7d5a38 57520-0764 HUMAN OTC DRUG Rheumatic Tonic Ginkgo biloba, Dioscorea villosa, Glycyrrhiza glabra, Viscum album, Pinus sylvestris, Apis mellifica, Dulcamara, Kalmia latifolia, Lycopodium clavatum, Sulphur, LIQUID ORAL 20110819 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; DIOSCOREA VILLOSA ROOT; GINKGO; GLYCYRRHIZA GLABRA; KALMIA LATIFOLIA LEAF; LYCOPODIUM CLAVATUM SPORE; PINUS SYLVESTRIS FLOWERING TOP; SOLANUM DULCAMARA FLOWER; SULFUR; VISCUM ALBUM FRUITING TOP 12; 1; 1; 3; 12; 12; 6; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0769_56e87e84-a610-4895-8286-13419a3345cf 57520-0769 HUMAN OTC DRUG Appetite Control Thyroidinum, Cortisone aceticum, Anacardium orientale, Antimonium crudum, Ignatia amara, Natrum muriaticum, Staphysagria, Cortisol, LIQUID ORAL 20110808 UNAPPROVED HOMEOPATHIC Apotheca Company ANTIMONY TRISULFIDE; CORTISONE ACETATE; DELPHINIUM STAPHISAGRIA SEED; HYDROCORTISONE; SEMECARPUS ANACARDIUM JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THYROID 15; 15; 18; 30; 15; 15; 15; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0770_e8b212c4-ea62-4c70-b5e0-0d1bec988623 57520-0770 HUMAN OTC DRUG Dopamine Dopamine, LIQUID ORAL 20110808 UNAPPROVED HOMEOPATHIC Apotheca Company DOPAMINE 200 [hp_C]/mL 57520-0774_65227c4a-c9c9-407b-bfdc-87e1f4b76957 57520-0774 HUMAN OTC DRUG Borrelia Remedy Borrelia burgdorferi, LIQUID ORAL 20110816 20170208 UNAPPROVED HOMEOPATHIC Apotheca Company BORRELIA BURGDORFERI 1000 [hp_X]/mL 57520-0775_0b39058c-1682-4681-bb2d-0c3ab8793c4f 57520-0775 HUMAN OTC DRUG Adrenal Support Aralia quinquefolia , Humulus lupulus, Adrenalinum, Cortisone aceticum, Thyroidinum suis, Selenium metallicum, Arsenicum album, Calcarea carbonica, Convallaria majalis, Crotalus horridus, LIQUID ORAL 20110809 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; ARSENIC TRIOXIDE; CONVALLARIA MAJALIS; CORTISONE ACETATE; CROTALUS HORRIDUS HORRIDUS VENOM; EPINEPHRINE; HOPS; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA THYROID 3; 12; 12; 6; 12; 6; 3; 12; 12; 30; 12; 8; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0776_ac497c5c-cd51-4ad6-a587-c73b046715d9 57520-0776 HUMAN OTC DRUG Arthritis Care Colchicum autumnale, Propolis, Kalmia latifolia, Bryonia, Causticum, Kali carbonicum, Ledum palustre, Rhododendron chrysanthum, Rhus toxicodendron, Thuja occidentalis, GEL TOPICAL 20110926 UNAPPROVED HOMEOPATHIC Apotheca Company BRYONIA ALBA ROOT; CAUSTICUM; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; POTASSIUM CARBONATE; PROPOLIS WAX; RHODODENDRON AUREUM LEAF; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 12; 12; 6; 6; 12; 12; 6; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0777_fb927e05-fec0-4e00-878f-a3f8a215deaf 57520-0777 HUMAN OTC DRUG Itchy Gone Apis mellifica, Belladonna, Calcarea carbonica, Medusa, Mezereum, Rhus toxicodendron, Astacus fluviatilis, Chloralum, GEL TOPICAL 20110928 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ASTACUS ASTACUS; ATROPA BELLADONNA; CHLORAL HYDRATE; DAPHNE MEZEREUM BARK; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYSALIA PHYSALIS; TOXICODENDRON PUBESCENS LEAF 12; 15; 12; 15; 12; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0778_cec776b6-2985-4543-85f3-df3abb402851 57520-0778 HUMAN OTC DRUG Hemorrhoid Care Hamamelis virginiana, Aesculus hippocastanum, Aloe socotrina, Paeonia officinalis, Ignatia amara, Lycopodium clavatum, Nitricum acidum, Nux vomica, Phosphorus, Podophyllum peltatum, Pulsatilla, Sulphu GEL TOPICAL 20111108 UNAPPROVED HOMEOPATHIC Apotheca Company ALOE; CHELIDONIUM MAJUS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; KRAMERIA LAPPACEA ROOT; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PAEONIA OFFICINALIS ROOT; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR 6; 30; 1; 1; 12; 12; 12; 6; 12; 12; 12; 12; 12; 12 [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57520-0781_e7e21c86-8c41-4ddd-b05b-c6f355cf1f71 57520-0781 HUMAN OTC DRUG Bruises Gone Calendula officinalis, Arnica montana, Hypericum perforatum, Symphytum officinale, Bellis perennis, Ledum palustre, Sulphuricum acidum, Calcarea fluorica, Ferrum phosphoricum, Rhus toxicodendron, Ruta GEL TOPICAL 20110927 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE; SULFURIC ACID; TOXICODENDRON PUBESCENS LEAF 1; 12; 30; 1; 3; 30; 1; 12; 30; 30; 12; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g 57520-0787_205cd186-8a66-457d-86a1-10061666b427 57520-0787 HUMAN OTC DRUG Biological Complex II Anthracinum, LIQUID ORAL 20110826 UNAPPROVED HOMEOPATHIC Apotheca Company BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 30 [hp_C]/mL 57520-0788_1b5364bf-6c67-4630-b24e-c650feabc014 57520-0788 HUMAN OTC DRUG Headache Cimicifuga racemosa, Gelsemium sempervirens, Rhus toxicodendron, LIQUID ORAL 20110817 UNAPPROVED HOMEOPATHIC Apotheca Company BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON PUBESCENS LEAF 2; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0789_e076a2bb-6ba9-44da-9a31-ead3d3236c3f 57520-0789 HUMAN OTC DRUG Liver Drainage Berberis vulgaris, Chelidonium majus, Carduus marianus, Schisandra chinensis, Taraxacum officinale, Picrorhiza scrophulariiflora, Raphanus sativus, Viscum album Chromium gluconate, Cobaltum gluconate, LIQUID ORAL 20110825 UNAPPROVED HOMEOPATHIC Apotheca Company BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; CHROMIUM GLUCONATE; CICHORIUM INTYBUS FLOWER; COBALTOUS GLUCONATE; COPPER GLUCONATE; LACTIC ACID, L-; MAGNESIUM GLUCONATE; NEOPICRORHIZA SCROPHULARIIFLORA ROOT; PHENOL; PORK LIVER; PTELEA TRIFOLIATA BARK; RADISH; SCHISANDRA CHINENSIS FRUIT; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SULFUR IODIDE; SUS SCROFA GALLBLADDER; SUS SCROFA PANCREAS; TARAXACUM OFFICINALE; VANADIUM; VERBENA OFFICINALIS FLOWERING TOP; VISCUM ALBUM FRUITING TOP 1; 1; 6; 8; 6; 6; 6; 6; 3; 8; 8; 6; 3; 2; 2; 6; 8; 6; 8; 8; 2; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0790_3239be08-9091-44c6-9a49-c45deb8abd1a 57520-0790 HUMAN OTC DRUG Tryptophan Tryptophan, LIQUID ORAL 20110817 UNAPPROVED HOMEOPATHIC Apotheca Company TRYPTOPHAN 6 [hp_X]/mL 57520-0795_4c23d753-9e06-4ffb-ac49-6acf5d90eea7 57520-0795 HUMAN OTC DRUG Caffeic Acid Caffeic acid, LIQUID ORAL 20110829 UNAPPROVED HOMEOPATHIC Apotheca Company CAFFEIC ACID 6 [hp_X]/mL 57520-0797_81766789-b681-40a3-a198-04170ebace55 57520-0797 HUMAN OTC DRUG Coniferyl Alcohol Coniferyl alcohol, LIQUID ORAL 20110824 UNAPPROVED HOMEOPATHIC Apotheca Company CONIFERYL ALCOHOL 6 [hp_X]/mL 57520-0801_21df286b-cb44-47d4-a788-b38439183566 57520-0801 HUMAN OTC DRUG FNG Berberis vulgaris, Cochlearia armoracia, Echinacea, Hydrastis canadensis, Lomatium dissectum, Myrrha, Tabebuia impetiginosa, Propolis, Glandula suprarenalis suis, Thymus suis, Ferrum metallicum, LIQUID ORAL 20110831 UNAPPROVED HOMEOPATHIC Apotheca Company ALTERNARIA ALTERNATA; ASPERGILLUS NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BERBERIS VULGARIS ROOT BARK; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA; GOLDENSEAL; HORSERADISH; IRIDIUM; IRON; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MUCOR RACEMOSUS; MYRRH; PHOSPHORIC ACID; PROPOLIS WAX; PULSATILLA VULGARIS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; SELENIUM; STACHYBOTRYS CHARTARUM; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; ZINC 12; 12; 12; 3; 12; 12; 3; 3; 3; 12; 12; 3; 12; 12; 3; 12; 6; 12; 12; 12; 12; 12; 8; 8; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0802_e57c0bfa-a754-4889-ab04-1d78d00ac2c3 57520-0802 HUMAN OTC DRUG Formaldehyde Formalinum, LIQUID ORAL 20110822 UNAPPROVED HOMEOPATHIC Apotheca Company FORMALDEHYDE 6 [hp_X]/mL 57520-0804_7949200b-8690-4a22-9308-f72e47419a61 57520-0804 HUMAN OTC DRUG Norepinephrine Norepinephrine, LIQUID ORAL 20110822 UNAPPROVED HOMEOPATHIC Apotheca Company NOREPINEPHRINE 6 [hp_X]/mL 57520-0805_2df7d6c8-cf6f-4389-ab98-26715ac02a69 57520-0805 HUMAN OTC DRUG Upper Respiratory Staph Strep Combo Staphylococcus aureus, Klebsiella pneumoniae, Haemophilus influenzae, LIQUID ORAL 20110829 UNAPPROVED HOMEOPATHIC Apotheca Company HAEMOPHILUS INFLUENZAE; KLEBSIELLA PNEUMONIAE; STAPHYLOCOCCUS AUREUS 12; 15; 15 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 57520-0833_d3c13cee-444f-47d9-99f2-4352ee817120 57520-0833 HUMAN OTC DRUG Perfect Sleep Adenosine triphosphate, Coenzyme A, Coenzyme Q10, Pineal Gland Suis, Sarcolacticum acidum, Melatonin, Pyrrole, Tryptophan, Arsenicum album, Avena sativa, LIQUID ORAL 20110826 UNAPPROVED HOMEOPATHIC Apotheca Company ADENOSINE TRIPHOSPHATE; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; COENZYME A; LACTIC ACID, L-; MATRICARIA RECUTITA; MELATONIN; MERCURIC CHLORIDE; PASSIFLORA INCARNATA FLOWER; PYRROLE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE; SILICON DIOXIDE; SUS SCROFA PINEAL GLAND; TRYPTOPHAN; UBIDECARENONE; ZINC VALERATE DIHYDRATE 8; 10; 10; 10; 8; 8; 10; 8; 10; 10; 8; 30; 30; 10; 8; 8; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0835_78aae604-0cd6-4554-bcd9-0b3af9905696 57520-0835 HUMAN OTC DRUG Acetylcholine Chloride Acetylcholine chloride LIQUID ORAL 20110909 UNAPPROVED HOMEOPATHIC Apotheca Company ACETYLCHOLINE CHLORIDE 6 [hp_X]/mL 57520-0836_51ed9468-45d9-4606-86ab-0b39d8fa5b31 57520-0836 HUMAN OTC DRUG Aspartame MSG Detox Chelidonium majus, Phytolacca decandra, Arnica Montana, Nitricum acidum, Nux vomica, Phosphoricum acidum, Aspartic acid, Diketopiperazine, Dopamine, Formalinum, LIQUID ORAL 20110824 UNAPPROVED HOMEOPATHIC Apotheca Company 2,5-PIPERAZINEDIONE; ARNICA MONTANA; ASPARTIC ACID; CHELIDONIUM MAJUS; DOPAMINE; FORMALDEHYDE; FORMIC ACID; METHYL ALCOHOL; MONOSODIUM GLUTAMATE; NITRIC ACID; PHENYLALANINE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; STRYCHNOS NUX-VOMICA SEED 30; 6; 30; 3; 30; 30; 30; 30; 30; 12; 30; 12; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0838_bc36e5be-ec18-4bc5-b51f-afbb3ce70401 57520-0838 HUMAN OTC DRUG Sulphur Remedy Sulphur, Asclepias tuberosa, Bryonia, Dulcamara, LIQUID ORAL 20110822 UNAPPROVED HOMEOPATHIC Apotheca Company ASCLEPIAS TUBEROSA FLOWERING TOP; BRYONIA ALBA ROOT; SOLANUM DULCAMARA FLOWER; SULFUR 6; 10; 10; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0840_f463affd-1363-4fe2-b2ab-c69397dcb150 57520-0840 HUMAN OTC DRUG Ver Artemisia Vulgaris, Filix Mas, Cina, Melilotus Officinalis, LIQUID ORAL 20110912 UNAPPROVED HOMEOPATHIC Apotheca Company ARTEMISIA CINA FLOWER; ARTEMISIA VULGARIS ROOT; ASCARIS LUMBRICOIDES; BRUGIA MALAYI; CRYPTOSPORIDIUM PARVUM; DRYOPTERIS FILIX-MAS ROOT; ENTEROBIUS VERMICULARIS; GIARDIA LAMBLIA; GRAPHITE; IODINE; MELILOTUS OFFICINALIS POLLEN; MERCURIC CHLORIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; QUASSIA AMARA WOOD; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA; TAENIA SAGINATA; TAENIA SOLIUM; TEUCRIUM MARUM; THYMUS SERPYLLUM; TRICHINELLA SPIRALIS; TRICHOMONAS VAGINALIS 3; 2; 15; 39; 20; 2; 33; 18; 12; 12; 3; 12; 12; 3; 12; 8; 3; 20; 12; 3; 3; 15; 13 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 57520-0846_8ba6863a-3c60-4b4a-ac63-c54c519bf49b 57520-0846 HUMAN OTC DRUG Bio Wild Rose Wild rose, LIQUID ORAL 20111104 UNAPPROVED HOMEOPATHIC Apotheca Company ROSA CANINA FLOWER 6 [hp_X]/mL 57520-0870_482ee5fb-cdfb-46c7-b431-a1e1e58d21f0 57520-0870 HUMAN OTC DRUG Infectistat Baptisia tinctoria, Echinacea, Hydrastis canadensis, LIQUID ORAL 20110926 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAUSTICUM; COMFREY ROOT; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; SODIUM SULFATE; SULFUR; SUS SCROFA LUNG; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3; 3; 12; 12; 12; 3; 12; 12; 3; 3; 12; 3; 12; 12; 30; 12; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0888_fcda645f-c763-4326-8dff-3bfc3603f22d 57520-0888 HUMAN OTC DRUG Enviroforce Hydrastis canadensis, Phytolacca decandra, Sarsaparilla, Xanthoxylum fraxineum, Aurum metallicum, Carbo animalis, Causticum, Iodium Sulphur, Thuja occidentalis, LIQUID ORAL 20111108 UNAPPROVED HOMEOPATHIC Apotheca Company CARBO ANIMALIS; CAUSTICUM; GOLD; GOLDENSEAL; IODINE; PHYTOLACCA AMERICANA ROOT; SMILAX REGELII ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ZANTHOXYLUM AMERICANUM BARK 12; 12; 12; 3; 12; 3; 3; 30; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0900_4c548e3c-f209-44dd-82e9-f25ee6b20dd9 57520-0900 HUMAN OTC DRUG Biting Insects Antigens Apis mellifica, Hypericum perforatum, Ledum palustre, Cimex lectularius, Formica rufa, Pulex irritans, Vespa crabo, LIQUID ORAL 20111101 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; CIMEX LECTULARIUS; FORMICA RUFA; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PULEX IRRITANS; VESPA CRABRO 12; 15; 15; 12; 12; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0908_9a735933-1eaa-4a78-81f8-22f4fcac3c37 57520-0908 HUMAN OTC DRUG Detox II Solidago virgaurea, Baptisia tinctoria, Berberis vulgaris, Equisetum hyemale, Argentum nitricum, Cantharis, Capsicum annuum, Cuprum sulphuricum, Orthosiphon stamineus, Pareira brava, Sarsaparilla, Ter LIQUID ORAL 20111004 UNAPPROVED HOMEOPATHIC Apotheca Company AGATHOSMA BETULINA LEAF; APIS MELLIFERA VENOM; BAPTISIA TINCTORIA; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; CAPSICUM; CHONDRODENDRON TOMENTOSUM ROOT; CLERODENDRANTHUS SPICATUS LEAF; CUPRIC SULFATE; EQUISETUM HYEMALE; ESCHERICHIA COLI; GLYOXAL TRIMER DIHYDRATE; LYTTA VESICATORIA; MERCURIC CHLORIDE; QUERCETIN; SHIGELLA DYSENTERIAE; SILVER NITRATE; SMILAX REGELII ROOT; SODIUM PYRUVATE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA URETHRA; SUS SCROFA URINARY BLADDER; TURPENTINE 8; 8; 4; 4; 10; 6; 6; 6; 6; 4; 15; 10; 6; 8; 10; 30; 6; 6; 10; 3; 8; 8; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0912_b0cd4eeb-e54c-460d-8966-a56626fb5754 57520-0912 HUMAN OTC DRUG Lymph Drainage Citrus limonum, Echinacea, Scrophularia nodosa, Teucrium Scorodonia, Baptisia tinctoria, Lobelia inflata, Phytolacca decandra, Pinus sylvestris, Zincum gluconicum, Thuja occidentalis, Capsicum annuum, LIQUID ORAL 20110929 UNAPPROVED HOMEOPATHIC Apothecfa Company ARANEUS DIADEMATUS; ARSENIC TRIIODIDE; BAPTISIA TINCTORIA ROOT; CAPSICUM; CARPINUS BETULUS FLOWERING TOP; CENTAURIUM ERYTHRAEA FLOWER; COPPER GLUCONATE; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; LARIX DECIDUA FLOWERING TOP; LEMON JUICE; LOBELIA INFLATA; MANGANESE GLUCONATE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS FLOWERING TOP; SCROPHULARIA NODOSA; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; ZINC GLUCONATE 8; 8; 1; 6; 8; 8; 6; 1; 12; 8; 1; 3; 6; 3; 3; 1; 8; 8; 8; 1; 4; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0917_0bd4934a-4d0f-4a15-bf2a-c6273fe24294 57520-0917 HUMAN OTC DRUG Stay Well Echinacea purpurea, Argentum nitricum, Baptisia tinctoria, Galium aparine, Pulsatilla, Thuja occidentalis, Phosphorus, Thymus serpyllum, Echinacea, Sulphur, LIQUID ORAL 20111114 UNAPPROVED HOMEOPATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; GALIUM APARINE; PHOSPHORUS; PULSATILLA VULGARIS; SILVER NITRATE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; THYMUS SERPYLLUM 6; 3; 6; 6; 6; 6; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0918_8d6d09a2-7d0f-465a-b394-58ebe01f0df2 57520-0918 HUMAN OTC DRUG Trauma Drama Belladonna, Calendula officinalis, Bellis perennis, Hypericum perforatum, Arnica montana, Mercuris solubilis, Symphytum officinale, Rhus toxicodendron, Ruta graveolens LIQUID ORAL 20111111 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 30; 6; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 57520-0919_fd970425-7e31-4428-a428-9456d47f3675 57520-0919 HUMAN OTC DRUG Thyroid Rhythm Adrenalinum, Calcarea iodata, Kali iodatum, Pituitary bovine, Spleen bovine, Thymus bovine, Thyrodinum, Spongia tosta, Fucus vesiculosus, Calcarea fluorica, Ferrum iodatum, Iodium Calcarea carbonica, LIQUID ORAL 20111111 UNAPPROVED HOMEOPATHIC Apotheca Company BOS TAURUS PITUITARY GLAND; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM FLUORIDE; CALCIUM IODIDE; EPINEPHRINE; FERROUS IODIDE; FUCUS VESICULOSUS; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM IODIDE; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID, BOVINE 6; 6; 6; 8; 6; 6; 8; 6; 9; 30; 6; 30; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0920_d9f9a9c8-0aa1-4a37-b3f9-fc6474ec120f 57520-0920 HUMAN OTC DRUG Influenza Remedy Eucalyptus globulus, Ipecacuanha, Aconitum napellus, LIQUID ORAL 20111025 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; EUCALYPTUS GLOBULUS LEAF; IPECAC 3; 2; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0922_fd54ae81-aedb-43bf-9341-1f1a944084a8 57520-0922 HUMAN OTC DRUG Phloridzin Phloridzinum, LIQUID ORAL 20110929 UNAPPROVED HOMEOPATHIC Apotheca Company PHLORIZIN 6 [hp_X]/mL 57520-0923_e4adbd51-6b8c-4405-9eb2-8c7d6305071b 57520-0923 HUMAN OTC DRUG Stomach Spleen Meridian Opener Arsenicum album, Calcarea carbonica, Carduus marianus, Ceanothus americanus, Cinchona officinalis, Digitalis purpurea, Ignatia amara, Kali bichromicum, Lycopodium clavatum, LIQUID ORAL 20110930 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; CEANOTHUS AMERICANUS LEAF; CINCHONA OFFICINALIS BARK; DIGITALIS; LEAD; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; SILYBUM MARIANUM SEED; STRYCHNOS IGNATII SEED; VERATRUM VIRIDE ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0925_825c6ade-d54a-494e-a305-5f32a7b791e4 57520-0925 HUMAN OTC DRUG Arthritis Joints Gnaphalium polycephalum, Berberis vulgaris, Cimicifuga racemosa, Cinchona officinalis, Colocynthis, Ledum palustre, Ranunculus bulbosus, Aesculus hippocastanum, Borax, Cuprum aceticum, Kali carbonicum LIQUID ORAL 20111024 UNAPPROVED HOMEOPATHIC Apotheca Company AMMONIUM CHLORIDE; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CLAVICEPS PURPUREA SCLEROTIUM; CUPRIC ACETATE; HORSE CHESTNUT; LEDUM PALUSTRE TWIG; MERCURIC OXIDE, YELLOW; PALLADIUM; POTASSIUM CARBONATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER; SODIUM BORATE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; TRIBASIC CALCIUM PHOSPHATE; TRINITROPHENOL; ZINC 8; 4; 4; 4; 4; 6; 6; 6; 4; 10; 12; 6; 3; 6; 4; 10; 8; 10; 6; 30; 10; 12; 12; 12; 10; 12; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0927_bfeb9d83-2816-4d51-a0f4-ad09ab4e6e58 57520-0927 HUMAN OTC DRUG Eye Sarcode Eye suis, LIQUID ORAL 20111024 UNAPPROVED HOMEOPATHIC Apotheca Company SUS SCROFA EYE 30 [hp_C]/mL 57520-0929_edd187ce-ee6f-4600-b44d-73eeb605a14e 57520-0929 HUMAN OTC DRUG Pre-Dental Visit Juglans regia, Myosotis arvensis, Scrophularia nodosa, Teucrium scroodonia, Veronica officinalis, Equisetum arvense, Fumaria officinalis, Geranium robertianum, Nasturtium aquaticum, Natrum sulphuricum LIQUID ORAL 20111109 UNAPPROVED HOMEOPATHIC Apotheca Company ARANEUS DIADEMATUS; CLEMATIS VITALBA PRE-FLOWERING TOP; EQUISETUM ARVENSE TOP; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; JUGLANS REGIA LEAF; MYOSOTIS ARVENSIS; ORNITHOGALUM UMBELLATUM; PINUS SYLVESTRIS FLOWERING TOP; PRUNUS CERASIFERA FLOWER; RORIPPA NASTURTIUM-AQUATICUM; SCROPHULARIA NODOSA; SMILAX REGELII ROOT; SODIUM SULFATE; SUS SCROFA LYMPH; TEUCRIUM SCORODONIA FLOWERING TOP; THYROID, PORCINE; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 12; 8; 4; 12; 4; 5; 4; 8; 8; 3; 3; 8; 4; 8; 4; 3; 6; 4; 12; 3; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0931_e66804bd-f3c6-49cf-8f44-d345b2b98260 57520-0931 HUMAN OTC DRUG Addiclenz Beta vulgaris, Boldo, Chelidonium majus, Petroselinum sativum, Taraxacum officinale, Arsenicum album, Belladonna, Cobaltum metallicum, Cuprum metallicum, Iodium, Lycopodium clavatum, Phosphoricum acidum, Selenium metallicum, Zincum metallicum, LIQUID ORAL 20111104 20170419 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ASPARTAME; ATROPA BELLADONNA; BENZALKONIUM CHLORIDE; BETA VULGARIS; CHELIDONIUM MAJUS; COBALT; COPPER; FORMALDEHYDE; IODINE; LYCOPODIUM CLAVATUM SPORE; METHYLENE CHLORIDE; METHYLPARABEN; PETROSELINUM CRISPUM; PEUMUS BOLDUS LEAF; PHOSPHORIC ACID; PROPYLPARABEN; SELENIUM; SODIUM BENZOATE; SODIUM CITRATE; TARAXACUM OFFICINALE; TITANIUM DIOXIDE; ZINC; ZINC OXIDE 12; 30; 12; 30; 3; 3; 12; 12; 30; 12; 12; 30; 30; 3; 3; 12; 30; 12; 30; 30; 3; 30; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0932_9f87e452-2cff-4336-a291-ae7f533fde14 57520-0932 HUMAN OTC DRUG Bronchial Cough Coccus cacti, Drosera, Scilla maritima, Arsenicum iodatum, Causticum, Cuprum aceticum, Carbo vegetabilis, Kali Carbonicum, Lachesis mutus, LIQUID ORAL 20111028 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; ARSENIC TRIIODIDE; CAUSTICUM; CUPRIC ACETATE; DRIMIA MARITIMA BULB; DROSERA ROTUNDIFOLIA; LACHESIS MUTA VENOM; POTASSIUM CARBONATE; PROTORTONIA CACTI 12; 6; 6; 6; 4; 4; 12; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0934_44d92995-4a29-4eef-8817-f04cf56454a9 57520-0934 HUMAN OTC DRUG Joint Pain Arnica montana, Bryonia, Causticum, Rhus toxicodendron, Ferrum phosphoricum, LIQUID ORAL 20111102 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; FERRUM PHOSPHORICUM; TOXICODENDRON PUBESCENS LEAF 4; 4; 4; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0936_314ac7f9-9f44-41e7-a8a2-0b3722f032ea 57520-0936 HUMAN OTC DRUG Taurine Taurine, LIQUID ORAL 20111102 UNAPPROVED HOMEOPATHIC Apotheca Company TAURINE 6 [hp_X]/mL 57520-0937_3eaaa5f3-040d-46e8-8823-fd2f76ddeef9 57520-0937 HUMAN OTC DRUG Bio Crab Apple Crab Apple LIQUID ORAL 20111104 UNAPPROVED HOMEOPATHIC Apotheca Company MALUS SYLVESTRIS FLOWER 6 [hp_X]/mL 57520-0938_730e416d-40d2-4327-8424-8a1ff8ea6506 57520-0938 HUMAN OTC DRUG Bladder Kidney Meridian Opener Apis mellifica, Argentum nitricum, Berberis vulgaris, Cantharis, Equisetum arvense, Kali bichromicum, Lycopodium clavatum, Mercurius solubilis, Natrum muriaticum, Phosphorus, Rhus toxicodendron, Sepia LIQUID ORAL 20111116 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; EQUISETUM ARVENSE TOP; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MERCURIUS SOLUBILIS; PHOSPHORUS; POTASSIUM DICHROMATE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; TURPENTINE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0939_69590a5a-5dfc-4dac-912c-f341fc73f2e3 57520-0939 HUMAN OTC DRUG Focus RxS Alpha-ketoglutaricum acidum, ATP, Formicum acidum, Malicum acidum, Sarcolacticum acidum, Dulcamara, Hyoscyamus niger, Phosphorus, Sabina, Acetylcholine chlorice, Adrrenalinum, Dopamine, Gaba, Norepine LIQUID ORAL 20111107 UNAPPROVED HOMEOPATHIC Apotheca Company .ALPHA.-KETOGLUTARIC ACID; .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; ADENOSINE CYCLIC 3',5'-PHOSPHATE; ADENOSINE TRIPHOSPHATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; DOPAMINE; EPINEPHRINE; FORMIC ACID; HYOSCYAMUS NIGER; JUNIPERUS SABINA LEAFY TWIG; LACTIC ACID, L-; LYCOSA TARANTULA; MALIC ACID; NOREPINEPHRINE; OCTOPAMINE; PHENETHYLAMINE; PHOSPHORUS; PORK BRAIN; SEROTONIN; SHIGELLA DYSENTERIAE; SILICON DIOXIDE; SOLANUM DULCAMARA FLOWER; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA BRAINSTEM; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; TAURINE; TYRAMINE; VALERIAN; VERATRUM ALBUM ROOT 6; 6; 6; 8; 6; 30; 30; 6; 6; 6; 6; 6; 6; 30; 6; 6; 6; 6; 6; 8; 6; 30; 8; 6; 30; 8; 8; 8; 8; 8; 6; 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL 57520-0940_4d57343c-7d19-4ed3-8cdc-78ccf1081ec2 57520-0940 HUMAN OTC DRUG Healing Support Betula pendula, cortex, Caltha palustris, Galium aparine, Sedum acre, Thuja occidentalis, Urtica urens, Clematis erecta, Hedera helix, Juniperus communis, Ononis spinosa, Quillaja saponaria, Semperviv LIQUID ORAL 20111110 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; BETULA PENDULA BARK; CALCIUM FLUORIDE; CALTHA PALUSTRIS; CLEMATIS RECTA FLOWERING TOP; ECHINACEA, UNSPECIFIED; GALIUM APARINE; HEDERA HELIX FLOWERING TWIG; JUNIPER; NITRIC ACID; ONONIS REPENS WHOLE; PHOSPHORUS; QUILLAJA SAPONARIA BARK; RANCID BEEF; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; SILVER; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 12; 2; 8; 3; 4; 5; 3; 4; 4; 6; 4; 8; 4; 12; 3; 4; 8; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0942_58dd0037-1bc9-4420-941b-95d9c544d5c8 57520-0942 HUMAN OTC DRUG Petrochemical Detox Chelidonium majus, Symphytum officinale, Taraxacum officinale, Trifolium pratense, Acetone, Sodium triphosphate, Propylene glycol, Sodium benzene sulfonate, Ammonium muriaticum, Sodium lauryl sulfate, LIQUID ORAL 20111111 UNAPPROVED HOMEOPATHIC Apotheca Company ACETONE; AMMONIUM CHLORIDE; ARSENIC TRIOXIDE; BENZENESULFONIC ACID; CADMIUM SULFIDE; CHELIDONIUM MAJUS; COMFREY ROOT; GELSEMIUM SEMPERVIRENS ROOT; IRIDIUM; KEROSENE; LATRODECTUS MACTANS; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NITRIC ACID; PHOSPHORIC ACID; PLATINUM; PROPYLENE GLYCOL; SODIUM LAURYL SULFATE; SODIUM TRIPOLYPHOSPHATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; TURPENTINE 9; 9; 12; 9; 12; 3; 3; 12; 12; 12; 15; 12; 12; 12; 12; 12; 9; 9; 9; 12; 3; 3; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0949_b5cde4ba-64f4-4284-b14b-028d6fe792ee 57520-0949 HUMAN OTC DRUG Varico HP Calcarea Fluorica, Carbo Vegetabilis, Hamamelis Virginiana, Lachesis Mutus, Lycopodium Clavatum, Pulsatilla, Secale Cornutum, Staphysagria, Zincum Metallicum LIQUID ORAL 20111107 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; CALCIUM FLUORIDE; CLAVICEPS PURPUREA SCLEROTIUM; DELPHINIUM STAPHISAGRIA SEED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0951_4a3c0be7-b711-44d3-ae8e-6d936fa51e45 57520-0951 HUMAN OTC DRUG Gyno Complex Viburnum opulus, Magnesia phosphorica, Folliculinum, Pulsatilla, Borax, Mercurius solubilis, Nitricum acidum, Silicea, Thuja occidentalis, LIQUID ORAL 20111116 UNAPPROVED HOMEOPATHIC Apotheca Company ESTRONE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS; NITRIC ACID; PULSATILLA VULGARIS; SILICON DIOXIDE; SODIUM BORATE; THUJA OCCIDENTALIS LEAFY TWIG; VIBURNUM OPULUS BARK 12; 8; 30; 30; 12; 30; 30; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0954_7dd4de79-5475-440b-b78e-4514f95e7a27 57520-0954 HUMAN OTC DRUG Seafood Antigens Codfish, Flounder, Halibut, Mackerel, Tuna, Clam, Crab, Oyster, Scallops, Shrimp, Belladonna, Carbo animalis, Colocynthis, Kali Carbonicum, Lycopodium clavatum, Pulsatilla, LIQUID ORAL 20111117 UNAPPROVED HOMEOPATHIC Apotheca Company ATLANTIC HALIBUT; ATROPA BELLADONNA; BLUE CRAB; CARBO ANIMALIS; CITRULLUS COLOCYNTHIS FRUIT PULP; COD, UNSPECIFIED; EDIBLE OYSTER; EUROPEAN FLOUNDER; LYCOPODIUM CLAVATUM SPORE; POTASSIUM CARBONATE; PULSATILLA VULGARIS; QUAHOG, UNSPECIFIED; SCOMBEROMORUS CAVALLA WHOLE; SEA SCALLOP; SHRIMP, UNSPECIFIED; TUNA, UNSPECIFIED 9; 12; 9; 12; 12; 9; 9; 9; 12; 12; 12; 9; 9; 9; 9; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0955_a9321767-d9f4-4625-88a8-fd9dcf8b04ee 57520-0955 HUMAN OTC DRUG Bio Heather Heather, LIQUID ORAL 20111114 UNAPPROVED HOMEOPATHIC Apotheca Company CALLUNA VULGARIS FLOWERING TOP 6 [hp_X]/mL 57520-0957_60c0e38b-269d-431d-b706-9dd0a70cba91 57520-0957 HUMAN OTC DRUG Psoriaforce Baptisia tinctoria, Berberis vulgaris, Echinacea, Glycyrrhiza glabra, Hydrastis canadensis, Lappa major, Phytolacca decandra, Rhamnus frangula Lappa major, Phytolacca decandra, Rhamnus frangula, Rhamn LIQUID ORAL 20111114 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTIUM LAPPA ROOT; ARSENIC TRIIODIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; CLEMATIS RECTA FLOWERING TOP; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; FRANGULA ALNUS BARK; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; GOLDENSEAL; GRAPHITE; KEROSENE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SEPIA OFFICINALIS JUICE; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK 3; 12; 3; 3; 12; 12; 3; 3; 3; 3; 3; 12; 12; 12; 3; 12; 12; 12; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0958_2d79d577-6bbc-40c0-b4fe-783dfc9399ba 57520-0958 HUMAN OTC DRUG Kidney Tonic I Echinacea, Petroselinum sativum, Solidago virgaurea, Uva-ursi, Pareira brava, Glutathione, Kidney, Cantharis, Lycopodium clavatum, LIQUID ORAL 20111111 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; CHONDRODENDRON TOMENTOSUM ROOT; ECHINACEA, UNSPECIFIED; GLUTATHIONE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PETROSELINUM CRISPUM; PORK KIDNEY; SOLIDAGO VIRGAUREA FLOWERING TOP 1; 3; 1; 6; 12; 12; 1; 8; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0963_2ae98ffc-bb42-41c5-a155-6fe3b866b264 57520-0963 HUMAN OTC DRUG Lung Large Intestine Meridian Opener Aloe socotrina, Alumina, Apis mellifica, Arsenicum album, Baryta carbonica, Bryonia, Carbo vegetabilis, Chamomilla, Kali bichromicum, Phosphorus, Plumbum metallicum, Pyrogenium, Sulphur, LIQUID ORAL 20111118 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; ALOE; ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; LEAD; MATRICARIA RECUTITA; PHOSPHORUS; POTASSIUM DICHROMATE; RANCID BEEF; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-0964_4ac1767c-9e35-4343-a632-320ffbd195ed 57520-0964 HUMAN OTC DRUG Metab Ascorbicum acidum, Cysteinum, Manganum gluconate, Alpha-ketoglutaricum acidum, Fumaricum acidum, Germanium sesquioxide, Iodium, Magnesium metallicum, Natrum oxalaceticum, Pulsatilla, Thyroidinum suis, LIQUID ORAL 20111116 UNAPPROVED HOMEOPATHIC Apotheca Company .ALPHA.-KETOGLUTARIC ACID; ASCORBIC ACID; CYSTEINE; FUMARIC ACID; GERMANIUM SESQUIOXIDE; IODINE; MAGNESIUM; MANGANESE GLUCONATE; PULSATILLA VULGARIS; SODIUM DIETHYL OXALACETATE; THYROID, PORCINE; VANADIUM 12; 6; 9; 12; 12; 12; 12; 10; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0966_9f27d903-fc2d-4767-96ad-9864be7279f7 57520-0966 HUMAN OTC DRUG Cytomegalovirus Remedy Cytomegalovirus LIQUID ORAL 20111122 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN HERPESVIRUS 5 18 [hp_X]/mL 57520-0968_9de0e652-63cc-4131-958b-cf6f232d0e99 57520-0968 HUMAN OTC DRUG Thyropar Fucus vesiculosus, Spongia tosta, Glandula suprarenalis suis, Pituitaria glandula suis, Thyroidinum suis, Bromium, Calcarea carbonica, Iodium, Lachesis mutus, Pulsatilla, LIQUID ORAL 20111121 UNAPPROVED HOMEOPATHIC Apotheca Company BROMINE; FUCUS VESICULOSUS; IODINE; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE 12; 3; 12; 12; 12; 12; 3; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0969_e564cf7e-22c4-4642-a9f7-93ff250a7696 57520-0969 HUMAN OTC DRUG E.O.L. Cholesterinum, Stillingia sylvatica, Zincum gluconicum, Thiaminum hydrochloricum, 5-hydroxytryptophan, Betain HCL, Biotin, Cholinum CoQ10, Dl-methionine, L-alanine, L-cysteine, L-cystine, L-glutamic a LIQUID ORAL 20111229 UNAPPROVED HOMEOPATHIC Apotheca Company AESCULUS HIPPOCASTANUM FLOWER; ALANINE; AMINOBENZOIC ACID; BETAINE HYDROCHLORIDE; BIOTIN; CHOLECALCIFEROL; CHOLESTEROL; CHOLINE HYDROXIDE; COPPER; CYSTEINE; CYSTINE; GLUTAMIC ACID; ILEX AQUIFOLIUM FLOWERING TOP; LYSINE; MALUS SYLVESTRIS FLOWER; METHIONINE; OXITRIPTAN; POTASSIUM GLUCONATE; RACEMETHIONINE; SELENIUM; SELENIUM DIOXIDE; SERINE; STILLINGIA SYLVATICA ROOT; SUS SCROFA THYMUS; THIAMINE HYDROCHLORIDE; THYROID, PORCINE; UBIDECARENONE; ZINC GLUCONATE 30; 6; 6; 6; 6; 6; 3; 6; 8; 6; 6; 6; 30; 6; 30; 6; 6; 6; 6; 8; 8; 6; 3; 6; 4; 6; 6; 3 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0983_ed45964f-b77e-4436-9b8b-b178660906b0 57520-0983 HUMAN OTC DRUG Animal Antigens Arsenicum album, Nux vomica, Phosphorus, Canary feathers, Cat hair, Cattle epithelia, Chicken feathers, Dog epithelia, Duck feathers, Gerbil epithelia, Goat epithelia, Goose feathers, LIQUID ORAL 20111129 UNAPPROVED HOMEOPATHIC Apotheca Company ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ARSENIC TRIOXIDE; BOS TAURUS SKIN; CANIS LUPUS FAMILIARIS SKIN; CAPRA HIRCUS SKIN; CAVIA PORCELLUS SKIN; EQUUS CABALLUS SKIN; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; MELOPSITTACUS UNDULATUS FEATHER; MERIONES UNGUICULATUS SKIN; MESOCRICETUS AURATUS SKIN; MUS MUSCULUS SKIN; ORYCTOLAGUS CUNICULUS SKIN; PHOSPHORUS; RATTUS NORVEGICUS SKIN; SERINUS CANARIA FEATHER; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA SKIN 9; 9; 12; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 9; 9; 12; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0985_438193f3-a608-4152-ab85-645fe58047de 57520-0985 HUMAN OTC DRUG Thyropar Fucus vesiculosus, Spongia tosta, Glandula suprarenalis suis, Pituitaria glandula suis, Thyroidinum suis, Bromium, Calcarea carbonica, Iodium, Lachesis mutus, Pulsatilla, LIQUID ORAL 20111122 UNAPPROVED HOMEOPATHIC Apotheca Company BROMINE; FUCUS VESICULOSUS; IODINE; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE 12; 3; 12; 12; 12; 12; 3; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0990_9b79826d-63b2-40b3-9b99-6677acac8eb0 57520-0990 HUMAN OTC DRUG Venoforce I Aesculus hippocastanum, Collinsonia canadensis, Echinacea, Hamamelis virginiana, Pulsatilla, Arnica Montana, Carbo vegetabilis, Graphites,Hydrofluoricum acidum, Lycopodium clavatum, Nitricum acidum, N LIQUID ORAL 20111117 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; ARNICA MONTANA; COLLINSONIA CANADENSIS ROOT; ECHINACEA, UNSPECIFIED; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROFLUORIC ACID; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PAEONIA OFFICINALIS ROOT; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED 12; 12; 3; 3; 12; 3; 3; 12; 12; 12; 12; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0994_f4805ff4-1849-4036-921b-a5296aabe446 57520-0994 HUMAN OTC DRUG Hypothalmu Stim Aralia quinquefolia, Ginkgo biloba, Hydrocotyle asiatica, Brain, Hypothalamus, Pituitaria glandula, Phosphorus, Silicea, LIQUID ORAL 20111202 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; CENTELLA ASIATICA; GINKGO; PHOSPHORUS; PORK BRAIN; SILICON DIOXIDE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND 3; 3; 3; 12; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-0998_1872216c-6977-4246-b8e3-13d9a77b70af 57520-0998 HUMAN OTC DRUG Anpitua Stim Adrenocorticotrophin, Agnus castus, Baryta carbonica, Calcarea carbonica, Iodium, Lac caninum, Natrum muriaticum, Phosphoricum acidum, Sepia, Thyroidinum suis, LIQUID ORAL 20111205 UNAPPROVED HOMEOPATHIC Apotheca Company BARIUM CARBONATE; CANIS LUPUS FAMILIARIS MILK; CHASTE TREE; CORTICOTROPIN; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; THYROID, PORCINE 12; 12; 12; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1001_15438445-fcd3-4ce7-a6ad-f88d9102bda8 57520-1001 HUMAN OTC DRUG Coumarin Coumarinum, LIQUID ORAL 20111215 UNAPPROVED HOMEOPATHIC Apotheca Company COUMARIN 6 [hp_X]/mL 57520-1002_14c1a052-2969-4337-b161-0115860db155 57520-1002 HUMAN OTC DRUG Piperine Piperine, LIQUID ORAL 20111215 UNAPPROVED HOMEOPATHIC Apotheca Company PIPERINE 6 [hp_X]/mL 57520-1003_44d3e789-8dd8-4679-9dc4-9f3371c7e1a0 57520-1003 HUMAN OTC DRUG Quercetin Quercetin, LIQUID ORAL 20111216 UNAPPROVED HOMEOPATHIC Apotheca Company QUERCETIN 6 [hp_X]/mL 57520-1004_8c30f5d4-01a5-400c-a10d-22dd3f365ecc 57520-1004 HUMAN OTC DRUG Orchiforce Avena sativa, Damiana, Agnus castus, Caladium seguinum, Conium maculatum, Phosphoricum acidum, Phosphorus, Picricum acidum, LIQUID ORAL 20111205 UNAPPROVED HOMEOPATHIC Apotheca Company AVENA SATIVA FLOWERING TOP; CHASTE TREE; CONIUM MACULATUM FLOWERING TOP; DIEFFENBACHIA SEGUINE; PHOSPHORIC ACID; PHOSPHORUS; TRINITROPHENOL; TURNERA DIFFUSA LEAFY TWIG 3; 12; 12; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1005_fce5f90b-87ed-4531-ab66-0bdb9010228b 57520-1005 HUMAN OTC DRUG Hepataplex Beta vulgaris, Boldo, Carduus marianus, Chelidonium majus, Petroselinum sativum, Taraxacum officinale, Glutathione, Hepar suis, Lycopodium clavatum, Nux vomica, Phosphorus, LIQUID ORAL 20111221 UNAPPROVED HOMEOPATHIC Apotheca Company BETA VULGARIS; CHELIDONIUM MAJUS; GLUTATHIONE; LYCOPODIUM CLAVATUM SPORE; PETROSELINUM CRISPUM; PEUMUS BOLDUS LEAF; PHOSPHORUS; PORK LIVER; SILYBUM MARIANUM SEED; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 3; 3; 6; 12; 3; 3; 12; 6; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1018_6b377da5-4000-4d9b-9948-7314b51d3c79 57520-1018 HUMAN OTC DRUG Chemtox Triticum aestivum, Berberis vulgaris, Glycyrrhiza glabra, Lappa major, Phytolacca decandra, Rhamnus frangula, Rhamnus purshiana, Stillingia sylvatica, Trifolium pratense, Xanthoxylum fraxineum, Glandu LIQUID ORAL 20111221 UNAPPROVED HOMEOPATHIC Apotheca Company ACETIC ACID; ARCTIUM LAPPA ROOT; ATROPA BELLADONNA; BENZOIC ACID; BENZYL ALCOHOL; BERBERIS VULGARIS ROOT BARK; BORIC ACID; CHLORINE; CORTICOTROPIN; CORTISONE ACETATE; ESTRONE; EUGENOL; FRANGULA ALNUS BARK; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LEAD; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PETROLATUM; PHENYLBUTAZONE; PHOSPHORIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PORK LIVER; POTASSIUM SORBATE; RESORCINOL; SALICYLIC ACID; SORBITOL; STEARYL ALCOHOL; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; THYROID, PORCINE; TRIFOLIUM PRATENSE FLOWER; TRITICUM AESTIVUM WHOLE; XYLITOL; ZANTHOXYLUM AMERICANUM BARK 30; 3; 12; 30; 30; 3; 30; 30; 30; 30; 30; 30; 3; 3; 3; 30; 30; 30; 12; 12; 30; 30; 12; 12; 3; 8; 30; 30; 30; 30; 30; 3; 12; 8; 8; 8; 3; 1; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1019_eb9a55a2-1816-4bfb-9cb7-0c3368fb7b29 57520-1019 HUMAN OTC DRUG Cough HP Arsenicum album, Bryonia, Cuprum aceticum, Drosera, Ipecacuanha, Kali Carbonicum, Phosphorus, Pulsatilla, Spongia tosta, LIQUID ORAL 20111221 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPECAC; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1021_0cafdd55-113c-4e74-a2d9-025a12bbf555 57520-1021 HUMAN OTC DRUG Apiol Apiolum, LIQUID ORAL 20111213 UNAPPROVED HOMEOPATHIC Apotheca Company APIOLE (PARSLEY) 6 [hp_X]/mL 57520-1023_8e900056-ae2e-45f6-90a8-c06080ae8ff8 57520-1023 HUMAN OTC DRUG ASP Echinacea, Hydrastis canadensis, Tabebuia impetiginosa, Glandula suprarenalis suis, Thymus, Thyroidinum, Arsenicum album, Bryonia, Cocculus indicus, Colchicum autumnale, Ledum palustre, LIQUID ORAL 20111220 UNAPPROVED HOMEOPATHIC Apotheca Company ANAMIRTA COCCULUS SEED; ARSENIC TRIOXIDE; ASPERGILLUS FLAVUS; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; ECHINACEA, UNSPECIFIED; GOLDENSEAL; LEDUM PALUSTRE TWIG; MERCURIC CYANIDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; THYROID, PORCINE 12; 12; 30; 12; 12; 3; 3; 12; 12; 12; 12; 12; 12; 8; 8; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1024_599c92c5-63f0-4d92-883f-4bec3ee8f5de 57520-1024 HUMAN OTC DRUG Lym D Chelidonium majus, Echinacea, Hydrastis canadensis, Nasturtium aquaticum, Taraxacum officinale, Trifolium pratense, Urtica dioica, Thymus, Thyroidinum, Arsenicum album, Coccus cacti, LIQUID ORAL 20111219 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; BORRELIA BURGDORFERI; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PROTORTONIA CACTI; RORIPPA NASTURTIUM-AQUATICUM; SUS SCROFA THYMUS; TARAXACUM OFFICINALE; THYROID, PORCINE; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA 12; 12; 3; 3; 3; 200; 12; 12; 12; 3; 8; 3; 8; 12; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1028_b061e070-5435-4498-ae17-c6826ebdeec8 57520-1028 HUMAN OTC DRUG Drainage Echinacea, Phytolacca decandra, Trifolium pratense, Calcarea iodata, Kali muriaticum, Nitricum acidum, Phosphoricum acidum, Sulphur iodatum, LIQUID ORAL 20120118 UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM IODIDE; ECHINACEA, UNSPECIFIED; NITRIC ACID; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; POTASSIUM CHLORIDE; SULFUR IODIDE; TRIFOLIUM PRATENSE FLOWER 12; 3; 12; 12; 3; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1029_aaa7a7f7-a0a4-4bc6-98bf-b6e50b10dcf2 57520-1029 HUMAN OTC DRUG FNG I Echinacea, Hydrastis canadensis, Lomatium dissectum, Nasturtium aquaticum, Tabebuia impetiginosa, Condurango, Ginkgo biloba, Ligusticum porteri, Astragalus membranaceus, Propolis, Thymus, Lycopodium c LIQUID ORAL 20120106 UNAPPROVED HOMEOPATHIC Apotheca Company ALTERNARIA ALTERNATA; ASPERGILLUS NIGER; ASTRAGALUS PROPINQUUS ROOT; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BOS TAURUS ADRENAL GLAND; BOS TAURUS THYMUS; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA, UNSPECIFIED; GINKGO; GOLDENSEAL; LIGUSTICUM PORTERI ROOT; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MARSDENIA CONDURANGO BARK; MUCOR RACEMOSUS; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PROPOLIS WAX; RHIZOPUS STOLONIFER; RORIPPA NASTURTIUM-AQUATICUM; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; TABEBUIA IMPETIGINOSA BARK 12; 12; 6; 12; 8; 8; 12; 12; 3; 4; 3; 4; 3; 12; 4; 12; 12; 12; 6; 12; 3; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1030_1114f327-6b49-4ec5-812e-3659bbab4b57 57520-1030 HUMAN OTC DRUG FNG II Echinacea, Hydrastis canadensis, Lomatium dissectum, Nasturtium aquaticum, Tabebuia impetiginosa, Iodium, Adrenalinum, Argentum metallicum, Thymus, Thyroidinum, Phosphoricum acidum, Candida albicans, LIQUID ORAL 20120109 UNAPPROVED HOMEOPATHIC Apotheca Company CANDIDA ALBICANS; ECHINACEA, UNSPECIFIED; EPINEPHRINE; GOLDENSEAL; IODINE; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PULSATILLA VULGARIS; RORIPPA NASTURTIUM-AQUATICUM; SEPIA OFFICINALIS JUICE; SILVER; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; THYROID, PORCINE 12; 3; 8; 3; 6; 3; 30; 12; 30; 3; 30; 8; 8; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1031_c7545f0a-8f14-4883-b518-0093311cd240 57520-1031 HUMAN OTC DRUG Thyro Tonic Chelidonium majus, Spongia tosta, Lac defloratum, Fucus vesiculosus, Hepar suis, Pituitary (suis), Thyroidinum (suis), Calcarea carbonica, Ferrum iodatum Iodium, Kali iodatum, Molybdenum metallicum, P LIQUID ORAL 20111229 UNAPPROVED HOMEOPATHIC Apotheca Company CHELIDONIUM MAJUS; FERROUS IODIDE; FUCUS VESICULOSUS; IODINE; MOLYBDENUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK LIVER; POTASSIUM IODIDE; PULSATILLA VULGARIS; SKIM MILK; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE 3; 12; 6; 12; 12; 12; 8; 12; 12; 4; 3; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1032_547a701c-afe6-45b0-90ec-1641846e2a26 57520-1032 HUMAN OTC DRUG Hepatatox Triticum aestivum, Chelidonium majus, Taraxacum officinale, Glutathione, Hepar suis, Thyroidinum (suis), Lycopodium clavatum, Nux vomica, Phosphoricum acidum, LIQUID ORAL 20120131 UNAPPROVED HOMEOPATHIC Apotheca Company ACETIC ACID; BENZOIC ACID; BENZYL ALCOHOL; BORIC ACID; CHELIDONIUM MAJUS; CHLORINE; CORTICOTROPIN; CORTISONE ACETATE; ESTRONE; EUGENOL; GLUTATHIONE; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LEAD; LYCOPODIUM CLAVATUM SPORE; PETROLATUM; PHENYLBUTAZONE; PHOSPHORIC ACID; PORK LIVER; POTASSIUM SORBATE; RESORCINOL; SALICYLIC ACID; SORBITOL; STEARYL ALCOHOL; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; THYROID, PORCINE; WHEAT; XYLITOL 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 6; 30; 30; 30; 12; 30; 30; 12; 8; 30; 30; 30; 30; 30; 12; 3; 8; 1; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1034_f40f5154-99aa-4020-b57f-49468c3672ec 57520-1034 HUMAN OTC DRUG Flu Tonic Echinacea, Uva-ursi, Baptisia tinctoria, Convallaria majalis, Kali muriaticum, Pinus sylvestris, Thuja occidentalis, Bryonia, Condurango, Crotalus horridus, Ginkgo biloba, Lachesis mutus, Selenium met LIQUID ORAL 20111229 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA, UNSPECIFIED; GINKGO; LACHESIS MUTA VENOM; MARSDENIA CONDURANGO BARK; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM CHLORIDE; SELENIUM; TABEBUIA IMPETIGINOSA BARK; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP 1; 3; 12; 6; 12; 1; 12; 12; 12; 6; 6; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1035_b5d8178c-bc87-4d2d-91aa-e3ac98a3df43 57520-1035 HUMAN OTC DRUG Lymph II Echinacea, Phytolacca decandra, Collnsonia canadensis, Kali iodatum, Pinus sylvestris, Pix liquida, Ferrum phosphoricum, Aesculus hippocastanum, Baryta carbonica, Berberis vulgaris, Bufo rana, Calcare LIQUID ORAL 20120109 UNAPPROVED HOMEOPATHIC Apotheca Company BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BUFO BUFO CUTANEOUS GLAND; CALCIUM SULFIDE; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; ECHINACEA, UNSPECIFIED; FERRUM PHOSPHORICUM; HORSE CHESTNUT; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PINE TAR; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM IODIDE; PULSATILLA VULGARIS; SILICON DIOXIDE; SODIUM CHLORIDE; STELLARIA MEDIA; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TRIBASIC CALCIUM PHOSPHATE; TURPENTINE; WOOD CREOSOTE 12; 12; 12; 12; 12; 3; 3; 8; 12; 12; 12; 12; 12; 12; 3; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1036_7cd5c595-3a76-4695-bf12-8d379f169458 57520-1036 HUMAN OTC DRUG Female Stimulant Aquilegia vulgaris, Hydrastis canadensis, Lilium tigrinum, Bovista, Cypripedium pubescens, Apiolum, Apis venenum purum, Cor (suis), Funiculus umbilicalis suis, Glandula suprarenalis suis, Kreosotum, O LIQUID ORAL 20120123 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITIC ACID, (Z)-; ALCALIGENES FAECALIS; APIOLE (PARSLEY); APIS MELLIFERA VENOM; AQUILEGIA VULGARIS; CYPRIPEDIUM PARVIFOLUM ROOT; ESCHERICHIA COLI; ESTRADIOL; ESTRONE; GIANT PUFFBALL; GOLDENSEAL; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM FLOWERING TOP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS; PORK HEART; PROGESTERONE; SEPIA OFFICINALIS JUICE; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; SUS SCROFA UTERUS; TESTOSTERONE; WOOD CREOSOTE 10; 30; 6; 8; 4; 6; 30; 30; 8; 6; 4; 10; 4; 10; 10; 8; 30; 10; 8; 8; 12; 13; 6; 8; 8; 30; 8 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1038_9b81bf47-67ca-41a0-b699-31c5243723e3 57520-1038 HUMAN OTC DRUG Neuro II Hydrastis canadensis, Taraxacum officinale, Acetylcholine chloride, Adrenalinum, Gaba, Histaminum hydrochloricum, Norepinephrine, Tyramine, LIQUID ORAL 20120116 UNAPPROVED HOMEOPATHIC Apotheca Company .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; EPINEPHRINE; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; NOREPINEPHRINE; TARAXACUM OFFICINALE; TYRAMINE 6; 6; 6; 3; 6; 6; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1039_61736877-7215-416c-bca1-67bbedb38539 57520-1039 HUMAN OTC DRUG Phenylalanine Phenylalanine, LIQUID ORAL 20100130 UNAPPROVED HOMEOPATHIC Apotheca Company PHENYLALANINE 6 [hp_X]/mL 57520-1040_78b1ab82-00ef-4b5a-94ae-ecc5cc94db39 57520-1040 HUMAN OTC DRUG Pyrrole Pyrrole, LIQUID ORAL 20120116 UNAPPROVED HOMEOPATHIC Apotheca Company PYRROLE 6 [hp_X]/mL 57520-1041_af5e0622-2e07-49fc-aaca-801ee8c30110 57520-1041 HUMAN OTC DRUG Sore Throat Juglans regia, Myosotis arvensis, Scrophularia nodosa, Teucrium scorodonia, Veronica officinalis, Equisetum hyemale, Fumaria officinalis, Geranium robertianum, Nasturtium aquaticum, Natrum sulphuricum LIQUID ORAL 20120118 UNAPPROVED HOMEOPATHIC Apotheca Company ARANEUS DIADEMATUS; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FLOWERING TOP; MYOSOTIS ARVENSIS; PINUS SYLVESTRIS LEAFY TWIG; RORIPPA NASTURTIUM-AQUATICUM; SCROPHULARIA NODOSA; SMILAX REGELII ROOT; SUS SCROFA LYMPH; TEUCRIUM SCORODONIA FLOWERING TOP; THYROID, PORCINE; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP 6; 4; 12; 4; 5; 4; 3; 3; 4; 4; 3; 6; 12; 3; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1042_c5e4eaaa-046d-4317-bc13-ae2cff91dd96 57520-1042 HUMAN OTC DRUG Bacto Plus Baptisia tinctoria, Echinacea, Phytolacca decandra, Aconitum napellus, Arsenicum album, Belladonna, Ferrum phosphoricum, Lachesis mutus, Phosphorus, LIQUID ORAL 20111230 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; FERRUM PHOSPHORICUM; LACHESIS MUTA VENOM; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT 12; 12; 12; 3; 3; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1043_5f5183c1-998a-436a-bee3-953d3485a218 57520-1043 HUMAN OTC DRUG Bacto Plus HP Apis mellifica, Arsenicum album, Belladonna, Chamomilla, Echinacea, Lachesis mutus, Mercurius solubilis, Pulsatilla, Pyrogenium, Rhus toxicodendron, Silicea, LIQUID ORAL 20111230 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1044_5573ccc3-d2ff-42bc-aa44-dc8232242ce5 57520-1044 HUMAN OTC DRUG Viro Plus Echinacea, Hydrastis canadensis, Lomatium, Aconitum napellus, Arsenicum album, Belladonna, Eupatorium perfoliatum, Gelsemium sempervirens, Lachesis mutus, Rhus toxicodendron, Pyrogenium, LIQUID ORAL 20120105 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; LOMATIUM DISSECTUM ROOT; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 12; 12; 3; 12; 3; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1045_041df92b-2f51-47d4-8e1c-2e1e31dc8461 57520-1045 HUMAN OTC DRUG Fungal Plus Candida albicans, LIQUID ORAL 20111230 UNAPPROVED HOMEOPATHIC Apotheca Company CANDIDA ALBICANS 6 [hp_X]/mL 57520-1046_3bb65ce2-d1ec-4fb8-962d-cbbee117ae89 57520-1046 HUMAN OTC DRUG Lymph Plus Geranium robertianum, Nasturtium aquaticum, Aloe socotrina, Juglans regia, Myosotis, arvensis, Scrophularia nodosa, Teucrium scordonia, Apis mellifica, Equisetum hyemale, Fumaria officinalis, Natrum s LIQUID ORAL 20120104 UNAPPROVED HOMEOPATHIC Apotheca Company ALOE; APIS MELLIFERA; BARIUM CARBONATE; CALCIUM SULFIDE; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FLOWERING TOP; MYOSOTIS ARVENSIS; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS FLOWERING TOP; RORIPPA NASTURTIUM-AQUATICUM; SCROPHULARIA NODOSA; SMILAX REGELII ROOT; SODIUM SULFATE; SUS SCROFA PARATHYROID GLAND; SUS SCROFA THYMUS; TEUCRIUM SCORODONIA FLOWERING TOP; THYROID, PORCINE; VERONICA OFFICINALIS FLOWERING TOP 3; 4; 8; 8; 4; 4; 5; 3; 3; 3; 4; 4; 3; 3; 6; 4; 12; 12; 3; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1047_00b153a6-4f36-464d-b9eb-9cf0a07829f4 57520-1047 HUMAN OTC DRUG Dr. Pearsalls 500 Calorie Diet Protocol Drops Fucus vesiculosus, Cyanocobalamin, Glandula suprarenalis suis, Hepar suis, L-carnitine, L-ornithine, Antimonium crudum, Thyroidinum suis, Natrum sulphuricum, Pancreatinum, Hypothalamus (suis), LIQUID ORAL 20120202 UNAPPROVED HOMEOPATHIC Apotheca Company ANTIMONY TRISULFIDE; CYANOCOBALAMIN; FUCUS VESICULOSUS; LEVOCARNITINE; ORNITHINE; PANCRELIPASE; PORK LIVER; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; THYROID, PORCINE 8; 6; 2; 6; 6; 12; 6; 10; 6; 18; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1049_5e2a7e57-649e-46cf-897e-72e0a2e43894 57520-1049 HUMAN OTC DRUG Human Parvovirus Remedy Parvovirus LIQUID ORAL 20120208 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN PARVOVIRUS B19 15 [hp_X]/mL 57520-1051_d00da8fd-14d0-40fb-9c3a-69e2643df745 57520-1051 HUMAN OTC DRUG Evtox Cochlearia officinalis, Echinacea, Hydrastis canadensis, Lomatium dissectum, Tabebuia impetiginosa, Propolis, Glandula suprarenalis suis, Thymus (suis), Aranea diadema, Ipecacuanha, LIQUID ORAL 20120126 UNAPPROVED HOMEOPATHIC Apotheca Company ARANEUS DIADEMATUS; COCHLEARIA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; GOLDENSEAL; HUMAN HERPESVIRUS 4; HYDROCHLORIC ACID; IPECAC; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PROPOLIS WAX; SILICON DIOXIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; TOXICODENDRON PUBESCENS LEAF 12; 3; 3; 3; 30; 12; 12; 3; 12; 12; 6; 12; 8; 8; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1052_b7637a5d-54cf-4352-bdad-9e3df29623f6 57520-1052 HUMAN OTC DRUG Nephroplex Berberis vulgaris, Hydrangea arborescens, Petroselinum sativum, Solidago virgaurea, Uva-ursi, Rubia tinctorum, Glutathiona, Kidney (suis), Bryonia, Eupatorium purpureum, Mercurius corrosivus, LIQUID ORAL 20120120 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; EUTROCHIUM PURPUREUM ROOT; GLUTATHIONE; HYDRANGEA ARBORESCENS ROOT; MERCURIC CHLORIDE; PETROSELINUM CRISPUM; PORK KIDNEY; RUBIA TINCTORUM ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 3; 3; 12; 12; 6; 3; 12; 3; 6; 5; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1053_816fd2a4-d679-4476-ae7a-7b7cfa2486bd 57520-1053 HUMAN OTC DRUG Pancreaplex Chelidonium majus, Glycyrrhiza glabra, Hydrastis canadensis, Nux moschata, Rheum officinale, Syzygium jambolanum, Taraxacum officinale, Zingiber officinale, Glandula suprarenalis suis, Hepar suis, Pan LIQUID ORAL 20120127 UNAPPROVED HOMEOPATHIC Apotheca Company CHELIDONIUM MAJUS; GINGER; GLYCYRRHIZA GLABRA; GOLDENSEAL; KIDNEY BEAN; NUTMEG; PHOSPHORIC ACID; PHOSPHORUS; PORK LIVER; RHEUM OFFICINALE ROOT; SUS SCROFA ADRENAL GLAND; SUS SCROFA PANCREAS; SUS SCROFA PITUITARY GLAND; SYZYGIUM CUMINI SEED; TARAXACUM OFFICINALE; THYROID, PORCINE 3; 3; 3; 3; 12; 3; 12; 12; 6; 3; 6; 6; 6; 3; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1056_3a74036c-c863-4d01-937a-0b7894b306ce 57520-1056 HUMAN OTC DRUG Mentox HP Baryta carbonica, Calcarea carbonica, Lachesis mutus, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Phosphorus, LIQUID ORAL 20120120 UNAPPROVED HOMEOPATHIC Apotheca Company BARIUM CARBONATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1111_0a0329cb-24eb-4618-884a-efee16a5b1b5 57520-1111 HUMAN OTC DRUG H Acne Formula Calendula officinalis, Nux vomica, Silicea, OIL TOPICAL 20120313 UNAPPROVED HOMEOPATHIC Apotheca Company CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED 12; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 57520-1147_c6cf79b2-d44f-4a86-b79e-ce7972049a6d 57520-1147 HUMAN OTC DRUG HZ Formula Baptisia tinctoria, Echinacea, Lomatium dissectum, Tabebuia impetiginosa, Propolis, Spleen (suis), Thymus (suis), Thyroidinum (suis), Gelsemium sempervirens, Lycopodium clavatum, Nux vomica, LIQUID ORAL 20120306 UNAPPROVED HOMEOPATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; CANDIDA ALBICANS; CHLAMYDIA TRACHOMATIS; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN PAPILLOMAVIRUS; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; PROPOLIS WAX; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TABEBUIA IMPETIGINOSA BARK; THYROID, PORCINE; TRICHINELLA BRIVOTI 3; 30; 30; 3; 12; 30; 30; 30; 3; 12; 6; 12; 6; 6; 3; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57520-1251_9f627670-07a7-409f-b440-1595e21550a9 57520-1251 HUMAN OTC DRUG Cough and Cold Relief Allium Cepa, Arsenicum Album, Ferrum Phosphoricum, Lac Caninum, Natrum Muriaticum, Nux Vomica TABLET ORAL 20130830 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; CANIS LUPUS FAMILIARIS MILK; FERROSOFERRIC PHOSPHATE; ONION; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 57524-013_47dba2cd-a67e-468e-a073-b31ab7057f6e 57524-013 HUMAN OTC DRUG epHiderm Spot Treatment Salicylic Acid LOTION TOPICAL 20130110 OTC MONOGRAPH FINAL part358B KANTIAN SKINCARE, LLC SALICYLIC ACID 1 mg/g 57524-014_617841d6-9c6d-4dbf-ba9b-2c652b8d6b82 57524-014 HUMAN OTC DRUG Neutralyze Spot Treatment Salicylic Acid GEL TOPICAL 20141103 OTC MONOGRAPH FINAL part358B KANTIAN SKINCARE, LLC SALICYLIC ACID 1 mg/g 57525-000_1381108d-7aca-4690-ab51-63b59d2f9d81 57525-000 HUMAN OTC DRUG RITUALS Essential Anti-Aging Day SPF 15 sunscreen broad spectrum normal to dry skin AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20130320 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 25; 60; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL 57525-001_92a37eaf-3dc3-4976-9c85-733e18ab9f75 57525-001 HUMAN OTC DRUG RITUALS Active Firming Day sunscreen broad spectrum SPF 15 dry skin AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20130318 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 25; 60; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL 57525-002_774a8597-6e0d-4cb1-958e-9d7593bf700a 57525-002 HUMAN OTC DRUG RITUALS broad spectrum SPF 15 sunscreen Sensitive Skin Day AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20130320 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 25; 60; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL 57525-003_a311d2d9-b123-4a97-8521-bd0c69385390 57525-003 HUMAN OTC DRUG RITUALS SMOOTH OPERATOR caring lip balm broad spectrum SPF15 sunscreen 4.8g AVOBENZONE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20140929 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 30; 60; 60 mg/g; mg/g; mg/g 57525-011_eb9a0a98-bdd1-4ed9-8a8d-5fe3e6856794 57525-011 HUMAN OTC DRUG RITUALS precious mineral foundation broad spectrum SPF 15 sunscreen SHADE 11 TITANIUM DIOXIDE CREAM TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. TITANIUM DIOXIDE 61.6 mg/mL 57525-012_b861c95a-b08e-4782-83a4-0371392f6fe2 57525-012 HUMAN OTC DRUG RITUALS precious mineral foundation broad spectrum SPF 15 sunscreen SHADE 12 TITANIUM DIOXIDE CREAM TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. TITANIUM DIOXIDE 61.6 mg/mL 57525-013_23ad998e-82c0-4daf-9a06-d6b58276d4cd 57525-013 HUMAN OTC DRUG RITUALS precious mineral foundation broad spectrum SPF 15 sunscreen SHADE 13 TITANIUM DIOXIDE CREAM TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. TITANIUM DIOXIDE 61.6 mg/mL 57525-014_12a772e6-e57c-4ac2-8b46-04c40695332f 57525-014 HUMAN OTC DRUG RITUALS precious mineral foundation broad spectrum SPF 15 sunscreen SHADE 14 TITANIUM DIOXIDE CREAM TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. TITANIUM DIOXIDE 61.6 mg/mL 57525-015_246b36c3-17db-49ef-8a0c-ab5f2752946c 57525-015 HUMAN OTC DRUG RITUALS precious mineral foundation broad spectrum SPF 15 sunscreen SHADE 15 TITANIUM DIOXIDE CREAM TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. TITANIUM DIOXIDE 61.6 mg/mL 57525-016_fd3e82b1-7740-4787-b3e5-ff6fcb37f2dd 57525-016 HUMAN OTC DRUG RITUALS precious mineral foundation broad spectrum SPF 15 sunscreen SHADE 16 TITANIUM DIOXIDE CREAM TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. TITANIUM DIOXIDE 61.6 mg/mL 57525-021_e5f387ae-91aa-469f-b5e2-3d243277f086 57525-021 HUMAN OTC DRUG RITUALS broad spectrum SPF 15 sunscreen matt finish foundation SHADE 11 TITANIUM DIOXIDE CREAM TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. TITANIUM DIOXIDE 52.8 mg/mL 57525-022_5ab30573-7554-4879-98cb-6f61afc120b0 57525-022 HUMAN OTC DRUG RITUALS broad spectrum SPF 15 sunscreen matt finish foundation SHADE 12 TITANIUM DIOXIDE CREAM TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. TITANIUM DIOXIDE 52.8 mg/mL 57525-023_f4a432ce-41f0-46e9-be47-715585f8a888 57525-023 HUMAN OTC DRUG RITUALS broad spectrum SPF 15 sunscreen matt finish foundation SHADE 13 TITANIUM DIOXIDE CREAM TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. TITANIUM DIOXIDE 52.8 mg/mL 57525-024_3d234e60-953a-471f-badb-b6faabf2b484 57525-024 HUMAN OTC DRUG RITUALS broad spectrum SPF 15 sunscreen matt finish foundation SHADE 14 TITANIUM DIOXIDE CREAM TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. TITANIUM DIOXIDE 52.8 mg/mL 57539-0221_460ea4ed-64ab-4fe2-aac2-6dca496a204d 57539-0221 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20111001 ANDA ANDA040911 Novocol Inc. LIDOCAINE 5 g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 57541-000_8e7480a9-2466-4a03-9bba-bdc56a8535f9 57541-000 HUMAN OTC DRUG Dr. OH PATCH CAMPHOR (NATURAL), MENTHOL SOLUTION TOPICAL 20130725 OTC MONOGRAPH NOT FINAL part348 Dr. Oh Patch Inc. CAMPHOR (NATURAL); MENTHOL 1.42; .8 mg/100mg; mg/100mg 57544-180_7328bb5e-057f-47bb-bdf3-6684bb59fcac 57544-180 HUMAN OTC DRUG ProCure Hand Sanitizing ALCOHOL SWAB TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part333E TwinMed, LLC ALCOHOL 65.9 g/100g 57554-110_2d49daa7-aa02-4219-880b-e1697bde8a7e 57554-110 HUMAN OTC DRUG DermaWound Wound Care povidone-iodine OINTMENT TOPICAL 20130408 OTC MONOGRAPH NOT FINAL part333A Wound Care USA, LLC POVIDONE-IODINE 10 g/100g 57554-120_6221ba86-8b7f-48c8-8284-6950f9fc36b1 57554-120 HUMAN OTC DRUG DermaWound Wound Care Venous Stasis benzocaine hydrochloride OINTMENT TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part348 Wound Care USA, LLC BENZOCAINE 1.27 g/100g 57554-210_75843d3f-3297-4658-a790-9715ed016cc0 57554-210 HUMAN OTC DRUG Mend19 Wound Care povidone-iodine OINTMENT TOPICAL 20130408 OTC MONOGRAPH NOT FINAL part333A Wound Care USA, LLC POVIDONE-IODINE 10 g/100g 57554-220_5dea01fd-594b-4768-9308-057e8ae27660 57554-220 HUMAN OTC DRUG Mend19 Wound Care Venous Stasis benzocaine hydrochloride OINTMENT TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part348 Wound Care USA, LLC BENZOCAINE 1.27 g/100g 57557-100_28af1500-9e59-4101-bc90-d6a7e4bb184e 57557-100 HUMAN OTC DRUG Othree 50 Whitening Titanium Dioxide, Zinc Oxide, Octinoxate, Octocrylene CREAM TOPICAL 20130403 OTC MONOGRAPH NOT FINAL part352 Cellab Co., Ltd. OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 6; 4.8; 3.936; 4 g/80g; g/80g; g/80g; g/80g 57597-043_269671c0-9cfb-4125-9da6-03617d6f3cb0 57597-043 HUMAN OTC DRUG Wong To Yick External Analgesic Camphor Menthol Methyl Salicylate OIL TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part348 Wong To Yick Wood Lock Ointment Ltd CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 1; 1.6; 5 mL/10mL; mL/10mL; mL/10mL 57598-888_7a445838-8ad4-45f5-84d8-095ba08c4211 57598-888 HUMAN OTC DRUG Ultra Balm Menthol and Methyl Salicylate OINTMENT TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part348 Ling Nam Medicine Factory (H.K.) Ltd. MENTHOL; METHYL SALICYLATE 140; 232 mg/g; mg/g 57605-0001_ccded185-9744-4820-8a22-264c1a4a4856 57605-0001 HUMAN OTC DRUG HGH Hepar Suis, Oleum Animale, Human Growth Hormone, Pituitaria Glandula LIQUID ORAL 20131017 UNAPPROVED HOMEOPATHIC Pros, Inc. CERVUS ELAPHUS HORN OIL; PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 8; 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57605-0002_bd90d8a1-f133-4237-89d5-f9feb652d746 57605-0002 HUMAN OTC DRUG HGH (Original Formula) Hepar Suis, Human Growth Hormone, Pituitaria Glandula (suis) LIQUID ORAL 20140709 UNAPPROVED HOMEOPATHIC Pros, Inc. PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57605-0003_5e1075d1-1ee0-4f8d-9637-4473c3799576 57605-0003 HUMAN OTC DRUG HGH Hepar suis, Oleum animale, Human growth hormone, Pituitaria glandula (suis), SPRAY ORAL 20140416 UNAPPROVED HOMEOPATHIC Pros, Inc. CERVUS ELAPHUS HORN OIL; PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 8; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57607-001_1e78fa3e-a23d-47da-9fe7-ee0533fe66d5 57607-001 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20130101 OTC MONOGRAPH FINAL part344 Professional Hospital Supply, Inc. ISOPROPYL ALCOHOL .7 L/L 57613-006_b1dede96-fac9-4c60-98cf-4367974316f2 57613-006 HUMAN OTC DRUG Scrub Care Parachlorometaxylenol SOLUTION TOPICAL 19881201 OTC MONOGRAPH NOT FINAL part333A Productos Urologos de Mexico, S.A. de C.V. CHLOROXYLENOL 33 mg/mL 57613-007_b86fb8ae-0760-4740-8f0b-b1fc7be59b5f 57613-007 HUMAN OTC DRUG Scrub Care Chlorhexidine Gluconate SOLUTION TOPICAL 19981201 NDA NDA019793 Productos Urologos de Mexico, S.A. de C.V. CHLORHEXIDINE GLUCONATE 4 mg/100mL 57613-008_0398dad8-568e-4218-a873-b9d37764d52b 57613-008 HUMAN OTC DRUG Prevail One Step povidone-iodine and alcohol GEL TOPICAL 19970601 OTC MONOGRAPH NOT FINAL part333A Productos Urologos de Mexico, S.A. de C.V. ALCOHOL; POVIDONE-IODINE .62; 5 mL/mL; mg/mL 57613-009_48bac66d-8ae9-4f8a-9008-5394498f7874 57613-009 HUMAN OTC DRUG Prevail-FX One Step povidone-iodine and isopropyl alcohol SOLUTION TOPICAL 19980601 OTC MONOGRAPH NOT FINAL part333A Productos Urologos de Mexico, S.A. de C.V. ISOPROPYL ALCOHOL; POVIDONE-IODINE 725; 83 mg/mL; mg/mL 57619-300_b0ecc05d-727a-466b-8d09-20cce7d149e8 57619-300 HUMAN OTC DRUG Nazil Ofteno Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20100412 OTC MONOGRAPH FINAL part349 LABORATORIOS SOPHIA, S.A. DE C.V. NAPHAZOLINE HYDROCHLORIDE .2 mg/mL 57619-400_0979c31b-182d-4059-ae27-39113053d1dd 57619-400 HUMAN OTC DRUG ManzanillaSophia Sophia Chamomile (Matricaria Chamomilla L.) SOLUTION/ DROPS OPHTHALMIC 20100412 UNAPPROVED HOMEOPATHIC LABORATORIOS SOPHIA, S.A. DE C.V. MATRICARIA RECUTITA 3 [hp_X]/mL 57624-601_993d22e0-2d01-4c91-baef-fb4f0eded888 57624-601 HUMAN OTC DRUG Fresh N Up Benzalkonium chloride SOLUTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333A Rockline Industries, Inc BENZALKONIUM CHLORIDE .115 mL/100mL 57627-100_0264df5c-e5b8-41e4-8629-29e2998a254e 57627-100 HUMAN OTC DRUG Clear Complexion Spot Treatment Merle Norman SALICYLIC ACID GEL TOPICAL 20110418 OTC MONOGRAPH FINAL part358H Merle Norman Cosmetics, Inc SALICYLIC ACID 1 g/100g 57627-101_0cd30726-30c0-4a4b-932a-befca0ae7c2b 57627-101 HUMAN OTC DRUG Clear Complexion Moisturizer Merle Norman salicylic Acid LOTION TOPICAL 20110418 OTC MONOGRAPH FINAL part358H Merle Norman Cosmetics, Inc SALICYLIC ACID 2 g/100g 57627-102_d34e2a16-1384-403a-b4d2-bb454090a34f 57627-102 HUMAN OTC DRUG Clear Complexion Toner Merle Norman SALICYLIC ACID LOTION TOPICAL 20110418 OTC MONOGRAPH FINAL part358H Merle Norman Cosmetics, Inc SALICYLIC ACID .5 g/100mL 57627-103_4d6b51da-7775-4e5a-a841-63fdd35fb2b6 57627-103 HUMAN OTC DRUG Clear Complexion Cleanser Merle Norman Salicylic Acid GEL TOPICAL 20110419 OTC MONOGRAPH FINAL part333D Merle Norman SALICYLIC ACID 2 mg/100g 57627-107_908eb4f5-cd29-45eb-a00b-bbf92bedcd6c 57627-107 HUMAN OTC DRUG Lip Conditioner SPF 15 Merle Norman OCTINOXATE,OCTISALATE JELLY TOPICAL 20110421 OTC MONOGRAPH NOT FINAL part352 Merle Norman OCTINOXATE; OCTISALATE .278; .185 g/3.7g; g/3.7g 57627-108_538bda40-4adb-42db-a0b9-e1c643e1d14e 57627-108 HUMAN OTC DRUG Foundation Primer Plus SPF 15 Merle Norman OCTINOXATE, OCTISALATE CREAM TOPICAL 20110422 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; OCTISALATE 2.63; 1.75 g/35g; g/35g 57627-109_4b05dcff-2e77-4e3f-8533-c56f3f1edec0 57627-109 HUMAN OTC DRUG Preventage Hand Treatment Merle Norman OCTINOXATE,OXYBENZONE LOTION TOPICAL 20110423 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; OXYBENZONE 4; 2 g/100g; g/100g 57627-110_4195c24a-42de-41d0-88db-6fa65fea48a1 57627-110 HUMAN OTC DRUG Lasting Foundation SPF 12 Merle Norman TITANIUM DIOXIDE CREAM TOPICAL 20110422 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc TITANIUM DIOXIDE 2.4 g/30g 57627-112_ebdce9d0-fb5e-415c-aebe-8e5571453af6 57627-112 HUMAN OTC DRUG Liquid Makeup SPF 16 Merle Norman OCTINOXATE, OXYBENZONE LIQUID TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part352 Merle Norman OCTINOXATE; OXYBENZONE 2.25; .6 g/30mL; g/30mL 57627-113_2f19b0cb-3fcd-49c0-8f75-d55fa2505ec3 57627-113 HUMAN OTC DRUG Flawless Effect Liquid Foundation SPF 15 Merle Norman OCTINOXATE, OXYBENZONE LIQUID TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part352 Merle Norman OCTINOXATE; OXYBENZONE 2.25; .9 g/30g; g/30g 57627-115_bea3e534-37cb-4b0a-8ffa-f59a738f6974 57627-115 HUMAN OTC DRUG Timeless Age Defying SPF 20 Merle Norman OCTINOXATE, OXYBENZONE CREAM TOPICAL 20110505 OTC MONOGRAPH NOT FINAL part352 Merle Norman OCTINOXATE; OXYBENZONE 2.25; .6 g/30mL; g/30mL 57627-117_a49bef9e-65b7-48ab-b1e6-1416f83f087e 57627-117 HUMAN OTC DRUG Ultra Light Sunscreen Broad Spectrum SPF 50 Merle Norman Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20130329 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.39; 11.3; 5.65; 3.11; 6.78 g/113g; g/113g; g/113g; g/113g; g/113g 57627-119_32b12b3e-a65c-4d10-b5a0-f26528bcc5b0 57627-119 HUMAN OTC DRUG Preventage Firming Defense Normal/Oily Broad Spectrum SPF 15 Merle Norman Avobenzone, Octocrylene CREAM TOPICAL 20120815 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc AVOBENZONE; OCTOCRYLENE 1.064; 5.264 g/56g; g/56g 57627-120_4b484895-9c36-441c-8b3f-6228d8d718b2 57627-120 HUMAN PRESCRIPTION DRUG Merle Norman Preventage Firming Defense Normal/Oily Broad Spectrum SPF 15 Avobenzone, Octocrylene CREAM TOPICAL 20120815 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc AVOBENZONE; OCTOCRYLENE 1.064; 5.264 g/56g; g/56g 57627-121_46d55af3-116b-4bf1-a3df-d43897aae60d 57627-121 HUMAN OTC DRUG Preventage Firming Defense Creme Normal/Dry Merle Norman Avobenzone, Octocrylene CREAM TOPICAL 20120817 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc AVOBENZONE; OCTOCRYLENE 1.064; 5.264 g/56g; g/56g 57627-122_70ef2da9-5ec5-4151-a782-6b795a0cd609 57627-122 HUMAN PRESCRIPTION DRUG Merle Norman Preventage Hand Treatment SPF 15 Avobenzone, Octocrylene CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.147; 10.622 g/113g; g/113g 57627-123_ebedbe78-59cb-44f4-93e6-de6ae6afe172 57627-123 HUMAN OTC DRUG Bare Perfecting Makeup Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL 57627-124_869b56a7-9c4b-47ac-bdeb-4996c3a3ea92 57627-124 HUMAN OTC DRUG Vanilla Perfecting Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL 57627-125_8aca11b3-8e42-4eb2-ae3c-4e98e3f84d3e 57627-125 HUMAN OTC DRUG Ivory Perfecting Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL 57627-126_972ca5da-3509-46da-b115-301187683f60 57627-126 HUMAN OTC DRUG Alabaster Perfecting Makeup SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120907 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL 57627-127_574a9f01-99ae-4a44-b9ea-1a0b2acfbb33 57627-127 HUMAN OTC DRUG Merle Norman Alabaster Beige Perfecting Makeup SPF 25 octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL 57627-128_ccc1243f-ee89-4bd7-a03a-812a4d80d55b 57627-128 HUMAN OTC DRUG Creamy Beige Perfecting Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL 57627-129_f54a86bc-b35f-4771-b4f3-c1c737c2c21f 57627-129 HUMAN OTC DRUG Simply Beige Perfecting makeup SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 30; 30 g/30mL; g/30mL 57627-130_1aa36db3-0201-4f26-a2dc-ac55aae970e3 57627-130 HUMAN OTC DRUG Soft Bisque Perfecting Makeup SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120826 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL 57627-131_f9db5092-6e67-490d-9482-b9df938f1cb7 57627-131 HUMAN OTC DRUG Desert Beige Perfecting Makeup SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL 57627-132_cd6ea87e-d4f2-468f-827d-55b9a83cc97a 57627-132 HUMAN OTC DRUG Medium Deep Warm Perfecting Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 7.5; 7.1 g/100mL; g/100mL 57627-133_57212af1-c6af-4786-be40-4b5f64d9bab1 57627-133 HUMAN OTC DRUG Delicate Beige Perfecting Makeup SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL 57627-134_175ff96d-2a5e-4a7d-8bec-2d5b18fb5bd6 57627-134 HUMAN OTC DRUG Rich Almond Perfecting Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate,Titanium dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL 57627-135_cefc7d50-9d81-46ee-ba7f-2d840cdb5723 57627-135 HUMAN OTC DRUG Warm Honey Perfecting Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL 57627-136_1ac61037-0d20-4674-8199-43b6fc247de6 57627-136 HUMAN OTC DRUG Sun Beige Perfecting Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL 57627-137_26252ef0-8ca5-4860-8c3e-f765d52ebf23 57627-137 HUMAN OTC DRUG Deep Tan Perfecting Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 75; 71 mg/mL; mg/mL 57627-149_7fe3964c-3ed1-4a96-8ab2-72b94570bb65 57627-149 HUMAN OTC DRUG Anti-Aging Complex SPF 30 Merle Norman Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone EMULSION TOPICAL 20121108 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .93; 2.48; 1.24; .729; 1.55 g/31g; g/31g; g/31g; g/31g; g/31g 57627-150_532869f2-c1ae-4f64-9be0-af9f1a6e1be9 57627-150 HUMAN OTC DRUG Anti-Aging Complex Eye Treatment Merle Norman Octinoxate, Zinc Oxide LOTION TOPICAL 20121109 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics OCTINOXATE; ZINC OXIDE 1.18; 1.04 g/16g; g/16g 57627-151_5a9bedfe-af3f-4b17-91ee-96ceb0ab16a7 57627-151 HUMAN OTC DRUG Sheer Defense Tinted Moisturizer SPF 15 L10 Merle Norman Octinoxate, Titanium Dioxide LIQUID TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc. OCTINOXATE; TITANIUM DIOXIDE 7.5; 5.12 g/100g; g/100g 57627-152_d4218f95-6c12-489f-b355-c2b492d936a5 57627-152 HUMAN OTC DRUG Sheer Defense Tinted Moisturizer SPF15 L20 Merle Norman Octinoxate, Titanium Dioxide LIQUID TOPICAL 20121207 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc. OCTINOXATE; TITANIUM DIOXIDE 7.5; 5.02 g/100g; g/100g 57627-153_c8b6441e-5ad7-4b14-96b7-224b26ed6490 57627-153 HUMAN OTC DRUG Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15 M50 Merle Norman Octinoxate, Titanium Dioxide LIQUID TOPICAL 20121210 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc. OCTINOXATE; TITANIUM DIOXIDE 7.5; 4.19 g/100g; g/100g 57627-154_ad248ece-96cf-44a8-9bb6-f9b17fa36104 57627-154 HUMAN OTC DRUG Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15 MD 70 Merle Norman Octinoxate, Titanium Dioxide LIQUID TOPICAL 20121210 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc. OCTINOXATE; TITANIUM DIOXIDE 7.5; 3.67 g/100g; g/100g 57627-155_ea160008-f4dd-448c-82ff-dea6fd5545ca 57627-155 HUMAN OTC DRUG Sheer Defense Tinted Moisturizer SPF 15 ML 30 Merle Norman Octinoxate, Titanium Dioxide LIQUID TOPICAL 20121211 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc. OCTINOXATE; TITANIUM DIOXIDE 7.5; 4.79 g/100g; g/100g 57627-156_cef0ff82-5f5c-4787-aef5-88dd6fc0d8bd 57627-156 HUMAN OTC DRUG Sheer Defense Tinted Moisturizer SPF 15 ML 40 Merle Norman Octinoxate, Titanium Dioxide LIQUID TOPICAL 20121212 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc. OCTINOXATE; TITANIUM DIOXIDE 2.6; 15.3 g/35g; g/35g 57627-157_4c53a797-9e18-4afc-a6c1-13b32c8007de 57627-157 HUMAN OTC DRUG Bare Expert Finish Makeup Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g 57627-158_bfb6f8ac-08ba-4d3d-ac50-e4d30efeb6ff 57627-158 HUMAN OTC DRUG Preventage Hand Treatment Broad Spectrum SPF 15 Merle Norman Avobenzone, Octocrylene CREAM TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part352 Merle Norman AVOBENZONE; OCTOCRYLENE 1.9; 9.4 g/100g; g/100g 57627-159_4c53a797-9e18-4afc-a6c1-13b32c8007de 57627-159 HUMAN OTC DRUG Porcelain Expert Finish Makeup Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g 57627-160_4c53a797-9e18-4afc-a6c1-13b32c8007de 57627-160 HUMAN OTC DRUG Alabaster Beige Expert Finish Makeup Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g 57627-161_4c53a797-9e18-4afc-a6c1-13b32c8007de 57627-161 HUMAN OTC DRUG Creamy Beige Expert Finish Makeup Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g 57627-162_4c53a797-9e18-4afc-a6c1-13b32c8007de 57627-162 HUMAN OTC DRUG Simply Beige Expert Finish Makeup Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g 57627-163_4c53a797-9e18-4afc-a6c1-13b32c8007de 57627-163 HUMAN OTC DRUG Soft Bisque Expert Finish Makeup Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g 57627-164_4c53a797-9e18-4afc-a6c1-13b32c8007de 57627-164 HUMAN OTC DRUG Sand Expert Finish Makeup Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g 57627-165_4c53a797-9e18-4afc-a6c1-13b32c8007de 57627-165 HUMAN OTC DRUG Medium Expert Finish Makeup Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g 57627-166_4c53a797-9e18-4afc-a6c1-13b32c8007de 57627-166 HUMAN OTC DRUG Sandy Beige Expert Finish Makeup Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g 57627-167_4c53a797-9e18-4afc-a6c1-13b32c8007de 57627-167 HUMAN OTC DRUG Delicate Beige Expert Finish Makeup Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g 57627-168_4c53a797-9e18-4afc-a6c1-13b32c8007de 57627-168 HUMAN OTC DRUG Tan Expert Finish Makeup Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g 57627-169_4c53a797-9e18-4afc-a6c1-13b32c8007de 57627-169 HUMAN OTC DRUG Ivory Expert Finish Makeup Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g 57627-170_4cfb1305-f6da-418c-bc06-6cb55204dcfc 57627-170 HUMAN OTC DRUG CC Cream Broad Spectrum SPF 30 Merle Norman Homosalate, Octinoxate, Oxybenzone, Titanium Dioxide CREAM TOPICAL 20140619 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics HOMOSALATE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7; 2.5; 2; 4.1 g/100g; g/100g; g/100g; g/100g 57627-171_768fa6be-77a5-4be0-a1b1-c976a6e7aea6 57627-171 HUMAN OTC DRUG Anti-Blemish Foundation Primer Acne Treatment Gel Merle Norman Salicylic Acid GEL TOPICAL 20140630 OTC MONOGRAPH FINAL part358H Merle Norman Cosmetics, Inc SALICYLIC ACID 2 g/100g 57650-159_c493b3e3-c56d-4cf8-bd55-2a2c98b083db 57650-159 HUMAN OTC DRUG Samhealthyskin B.B. SUNSCREEN BROAD SPECTRUM SPF 40 TITANIUM DIOXIDE CREAM TOPICAL 20130425 OTC MONOGRAPH NOT FINAL part352 Samhealthyskin.COM LLC TITANIUM DIOXIDE 100 mg/mL 57660-000_85ed6eee-cf04-4dd1-8e06-6e87e1cc77e0 57660-000 HUMAN OTC DRUG PLAQUE HD ANTICAVITY FRESH MINT FLAVOR Professional Plaque-Identifying SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130610 OTC MONOGRAPH FINAL part355 TJA Health LLC SODIUM FLUORIDE .14 g/100g 57660-001_53de6235-c81b-4205-92bf-dd31bb56faa3 57660-001 HUMAN OTC DRUG PLAQUE HD ANTICAVITY BERRY BUBBLE GUM FLAVOR Professional Plaque-Identifying SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20140319 OTC MONOGRAPH FINAL part355 TJA Health LLC SODIUM FLUORIDE .14 g/100g 57664-001_94d53d15-5d4f-4b85-888b-adae1255c3af 57664-001 HUMAN PRESCRIPTION DRUG Pramipexole Pramipexole TABLET ORAL 20130523 ANDA ANDA091683 Caraco Pharmaceutical Laboratories, Ltd. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 57664-002_94d53d15-5d4f-4b85-888b-adae1255c3af 57664-002 HUMAN PRESCRIPTION DRUG Pramipexole Pramipexole TABLET ORAL 20130523 ANDA ANDA091683 Caraco Pharmaceutical Laboratories, Ltd. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 57664-003_94d53d15-5d4f-4b85-888b-adae1255c3af 57664-003 HUMAN PRESCRIPTION DRUG Pramipexole Pramipexole TABLET ORAL 20130523 ANDA ANDA091683 Caraco Pharmaceutical Laboratories, Ltd. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 57664-004_94d53d15-5d4f-4b85-888b-adae1255c3af 57664-004 HUMAN PRESCRIPTION DRUG Pramipexole Pramipexole TABLET ORAL 20130523 ANDA ANDA091683 Caraco Pharmaceutical Laboratories, Ltd. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 57664-005_94d53d15-5d4f-4b85-888b-adae1255c3af 57664-005 HUMAN PRESCRIPTION DRUG Pramipexole Pramipexole TABLET ORAL 20130523 ANDA ANDA091683 Caraco Pharmaceutical Laboratories, Ltd. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 57664-055_8858588a-91db-42f1-89fe-9a70b1bc369d 57664-055 HUMAN PRESCRIPTION DRUG Amlodipine Besylate AMLODIPINE BESYLATE TABLET ORAL 20121019 ANDA ANDA078552 Caraco Pharmaceutical Laboratories, Ltd. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 57664-056_8858588a-91db-42f1-89fe-9a70b1bc369d 57664-056 HUMAN PRESCRIPTION DRUG Amlodipine Besylate AMLODIPINE BESYLATE TABLET ORAL 20121019 ANDA ANDA078552 Caraco Pharmaceutical Laboratories, Ltd. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 57664-057_8858588a-91db-42f1-89fe-9a70b1bc369d 57664-057 HUMAN PRESCRIPTION DRUG Amlodipine Besylate AMLODIPINE BESYLATE TABLET ORAL 20121019 ANDA ANDA078552 Caraco Pharmaceutical Laboratories, Ltd. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 57664-070_bca6e06f-e9ea-4957-af87-453044fbf10b 57664-070 HUMAN OTC DRUG Ferrous Sulfate Ferrous Sulfate TABLET, FILM COATED ORAL 20140701 UNAPPROVED DRUG OTHER Sun Pharmaceutical Industries, Inc. FERROUS SULFATE 325 mg/1 57664-071_bca6e06f-e9ea-4957-af87-453044fbf10b 57664-071 HUMAN OTC DRUG Ferrous Sulfate Ferrous Sulfate TABLET, FILM COATED ORAL 20140701 UNAPPROVED DRUG OTHER Sun Pharmaceutical Industries, Inc. FERROUS SULFATE 325 mg/1 57664-102_e317c94f-a672-4c23-a0d2-608fb8a9af3b 57664-102 HUMAN PRESCRIPTION DRUG Hydrocodone bitartrate and ibuprofen Hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20130701 ANDA ANDA091633 Sun Pharmaceutical Industries, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 57664-103_90813662-c27e-4541-86a5-70b435533b69 57664-103 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 19950401 UNAPPROVED DRUG OTHER Caraco Pharmaceutical Laboratories, Ltd. SALSALATE 500 mg/1 57664-104_93cf9de2-9782-49bd-91cd-900c46a8176d 57664-104 HUMAN PRESCRIPTION DRUG bethanechol chloride bethanechol chloride TABLET ORAL 20090430 ANDA ANDA040897 Caraco Pharmaceutical Laboratories, Ltd. BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 57664-105_90813662-c27e-4541-86a5-70b435533b69 57664-105 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 19950401 UNAPPROVED DRUG OTHER Caraco Pharmaceutical Laboratories, Ltd. SALSALATE 750 mg/1 57664-106_93cf9de2-9782-49bd-91cd-900c46a8176d 57664-106 HUMAN PRESCRIPTION DRUG bethanechol chloride bethanechol chloride TABLET ORAL 20090430 ANDA ANDA040897 Caraco Pharmaceutical Laboratories, Ltd. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 57664-107_6928d9ab-4382-4b26-9cb6-709a11d3b02c 57664-107 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20090127 ANDA ANDA040863 Caraco Pharmaceutical Laboratories, Ltd. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 57664-108_6928d9ab-4382-4b26-9cb6-709a11d3b02c 57664-108 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20090127 ANDA ANDA040863 Caraco Pharmaceutical Laboratories, Ltd. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 57664-109_6928d9ab-4382-4b26-9cb6-709a11d3b02c 57664-109 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20090127 ANDA ANDA040863 Caraco Pharmaceutical Laboratories, Ltd. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 57664-112_f5bf497c-a72c-44b0-902b-44d11bbbad1c 57664-112 HUMAN PRESCRIPTION DRUG HydrOXYzine hydrochloride HydrOXYzine hydrochloride TABLET ORAL 20090331 ANDA ANDA040899 Caraco Pharmaceutical Laboratories, Ltd. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 57664-113_f5bf497c-a72c-44b0-902b-44d11bbbad1c 57664-113 HUMAN PRESCRIPTION DRUG HydrOXYzine hydrochloride HydrOXYzine hydrochloride TABLET ORAL 20090331 ANDA ANDA040899 Caraco Pharmaceutical Laboratories, Ltd. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 57664-114_f5bf497c-a72c-44b0-902b-44d11bbbad1c 57664-114 HUMAN PRESCRIPTION DRUG HydrOXYzine hydrochloride HydrOXYzine hydrochloride TABLET ORAL 20090331 ANDA ANDA040899 Caraco Pharmaceutical Laboratories, Ltd. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 57664-115_a818aeed-253b-44e7-b728-81837d284a53 57664-115 HUMAN PRESCRIPTION DRUG GEMFIBROZIL GEMFIBROZIL TABLET, FILM COATED ORAL 20090701 ANDA ANDA079239 Caraco Pharmaceutical Laboratories, Ltd. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 57664-116_e90d8111-03a7-42c8-9032-e1d834f3d4f7 57664-116 HUMAN PRESCRIPTION DRUG VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20120101 ANDA ANDA090529 Caraco Pharmaceutical Laboratories, Ltd. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 57664-117_e90d8111-03a7-42c8-9032-e1d834f3d4f7 57664-117 HUMAN PRESCRIPTION DRUG VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20120101 ANDA ANDA090529 Caraco Pharmaceutical Laboratories, Ltd. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 57664-118_e90d8111-03a7-42c8-9032-e1d834f3d4f7 57664-118 HUMAN PRESCRIPTION DRUG VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20120101 ANDA ANDA090529 Caraco Pharmaceutical Laboratories, Ltd. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 57664-119_45ad5425-58bc-46b3-8f6e-c01f4dd1d1e7 57664-119 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20130516 ANDA ANDA091401 Caraco Pharmaceutical Laboratories, Ltd. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 57664-120_45ad5425-58bc-46b3-8f6e-c01f4dd1d1e7 57664-120 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20130516 ANDA ANDA091401 Caraco Pharmaceutical Laboratories, Ltd. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 57664-124_98b9c198-0ac9-4b96-9cce-d042640610bb 57664-124 HUMAN PRESCRIPTION DRUG VALPROIC ACID Valproic Acid SOLUTION ORAL 20120418 ANDA ANDA090517 Caraco Pharmaceutical Laboratories, Ltd. VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 57664-126_07d35046-a1fc-4998-a7a6-1a4cb1ec2997 57664-126 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Sun Pharmaceutical Industries, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 57664-133_6e236450-8d76-4758-997c-71ad028da9e1 57664-133 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE CAPSULE ORAL 20080407 ANDA ANDA040587 Caraco Pharmaceutical Laboratories, Ltd. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 57664-134_6e236450-8d76-4758-997c-71ad028da9e1 57664-134 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE CAPSULE ORAL 20080407 ANDA ANDA040587 Caraco Pharmaceutical Laboratories, Ltd. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 57664-135_b9f244e4-bf34-4f84-9507-4a56e21b8d8e 57664-135 HUMAN PRESCRIPTION DRUG Nimodipine Nimodipine CAPSULE ORAL 20070628 ANDA ANDA077067 Caraco Pharmaceutical Laboratories, Ltd. NIMODIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 57664-136_6407174d-af30-4a16-bae6-010d0445252d 57664-136 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20100315 ANDA ANDA040865 Caraco Pharmaceutical Laboratories, Ltd. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 57664-137_93cf9de2-9782-49bd-91cd-900c46a8176d 57664-137 HUMAN PRESCRIPTION DRUG bethanechol chloride bethanechol chloride TABLET ORAL 20090430 ANDA ANDA040897 Caraco Pharmaceutical Laboratories, Ltd. BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 57664-138_93cf9de2-9782-49bd-91cd-900c46a8176d 57664-138 HUMAN PRESCRIPTION DRUG bethanechol chloride bethanechol chloride TABLET ORAL 20090430 ANDA ANDA040897 Caraco Pharmaceutical Laboratories, Ltd. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 57664-141_43ff115b-d54c-42f8-89b2-01b888b01a56 57664-141 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE SYRUP ORAL 20111003 ANDA ANDA091091 Sun Pharmaceutical Industries, Inc. RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 57664-146_8d298744-a4ce-4fed-9aca-4a83a3df88f2 57664-146 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SOLUTION ORAL 20090313 ANDA ANDA040891 Caraco Pharmaceutical Laboratories, Ltd. PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 57664-154_1f453684-204f-49e9-840b-2c7832e81f8f 57664-154 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131226 ANDA ANDA090535 Caraco Pharmaceutical Laboratories, Ltd. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 2.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57664-155_1f453684-204f-49e9-840b-2c7832e81f8f 57664-155 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131226 ANDA ANDA090535 Caraco Pharmaceutical Laboratories, Ltd. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57664-156_1f453684-204f-49e9-840b-2c7832e81f8f 57664-156 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131226 ANDA ANDA090535 Caraco Pharmaceutical Laboratories, Ltd. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57664-160_1f453684-204f-49e9-840b-2c7832e81f8f 57664-160 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131226 ANDA ANDA090535 Caraco Pharmaceutical Laboratories, Ltd. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57664-162_9a2a7fa7-3bde-4095-b10d-3e7192e1048a 57664-162 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Caraco Pharmaceutical Laboratories, Ltd. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 57664-166_9a2a7fa7-3bde-4095-b10d-3e7192e1048a 57664-166 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Caraco Pharmaceutical Laboratories, Ltd. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 57664-167_9a2a7fa7-3bde-4095-b10d-3e7192e1048a 57664-167 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Caraco Pharmaceutical Laboratories, Ltd. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 57664-170_07d35046-a1fc-4998-a7a6-1a4cb1ec2997 57664-170 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Sun Pharmaceutical Industries, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 57664-175_6e07664e-1e21-4551-9b4b-868f344dd972 57664-175 HUMAN PRESCRIPTION DRUG Paromomycin Sulfate Paromomycin Sulfate CAPSULE ORAL 19971001 ANDA ANDA064171 Caraco Pharmaceutical Laboratories, Ltd. PAROMOMYCIN SULFATE 250 mg/1 Antiprotozoal [EPC] 57664-176_07d35046-a1fc-4998-a7a6-1a4cb1ec2997 57664-176 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Sun Pharmaceutical Industries, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 57664-181_a0fe22f2-9063-49d4-831f-2271643b7d0a 57664-181 HUMAN PRESCRIPTION DRUG cetirizine hydrochloride cetirizine hydrochloride SYRUP ORAL 20091116 ANDA ANDA090191 Caraco Pharmaceutical Laboratories, Ltd. CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 57664-185_e40d5a91-630a-4583-842d-6d952892deff 57664-185 HUMAN PRESCRIPTION DRUG promethazine hydrochloride and codeine phosphate promethazine hydrochloride and codeine phosphate SYRUP ORAL 20100317 ANDA ANDA090180 Caraco Pharmaceutical Laboratories, Ltd. CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 57664-187_f6faac2f-b6d8-4055-9cbf-3c5de77cdd7b 57664-187 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20090512 ANDA ANDA090659 Caraco Pharmaceutical Laboratories, Ltd. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57664-195_1676ef78-7ed3-4481-82ce-3c7ff2d9db9e 57664-195 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20140417 ANDA ANDA090651 Caraco Pharmaceutical Laboratories, Ltd. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 57664-203_e317c94f-a672-4c23-a0d2-608fb8a9af3b 57664-203 HUMAN PRESCRIPTION DRUG Hydrocodone bitartrate and ibuprofen Hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20130701 ANDA ANDA091633 Sun Pharmaceutical Industries, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 57664-210_94d53d15-5d4f-4b85-888b-adae1255c3af 57664-210 HUMAN PRESCRIPTION DRUG Pramipexole Pramipexole TABLET ORAL 20130523 ANDA ANDA091683 Caraco Pharmaceutical Laboratories, Ltd. PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 57664-212_684857ab-1155-450b-aedb-6da9af04301f 57664-212 HUMAN PRESCRIPTION DRUG RISPERIDONE risperidone TABLET ORAL 20140310 ANDA ANDA078036 Caraco Pharmaceutical Laboratories, Ltd. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 57664-213_684857ab-1155-450b-aedb-6da9af04301f 57664-213 HUMAN PRESCRIPTION DRUG RISPERIDONE risperidone TABLET ORAL 20140310 ANDA ANDA078036 Caraco Pharmaceutical Laboratories, Ltd. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 57664-214_684857ab-1155-450b-aedb-6da9af04301f 57664-214 HUMAN PRESCRIPTION DRUG RISPERIDONE risperidone TABLET ORAL 20140310 ANDA ANDA078036 Caraco Pharmaceutical Laboratories, Ltd. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 57664-215_684857ab-1155-450b-aedb-6da9af04301f 57664-215 HUMAN PRESCRIPTION DRUG RISPERIDONE risperidone TABLET ORAL 20140310 ANDA ANDA078036 Caraco Pharmaceutical Laboratories, Ltd. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 57664-216_684857ab-1155-450b-aedb-6da9af04301f 57664-216 HUMAN PRESCRIPTION DRUG RISPERIDONE risperidone TABLET ORAL 20140310 ANDA ANDA078036 Caraco Pharmaceutical Laboratories, Ltd. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 57664-217_684857ab-1155-450b-aedb-6da9af04301f 57664-217 HUMAN PRESCRIPTION DRUG RISPERIDONE risperidone TABLET ORAL 20140310 ANDA ANDA078036 Caraco Pharmaceutical Laboratories, Ltd. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 57664-223_f6faac2f-b6d8-4055-9cbf-3c5de77cdd7b 57664-223 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20090512 ANDA ANDA090659 Caraco Pharmaceutical Laboratories, Ltd. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57664-224_f6faac2f-b6d8-4055-9cbf-3c5de77cdd7b 57664-224 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20090512 ANDA ANDA090659 Caraco Pharmaceutical Laboratories, Ltd. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57664-228_140e73da-c616-46af-9f13-f09ab54a324a 57664-228 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET ORAL 20130816 ANDA ANDA090710 Sun Pharmaceutical Industries, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57664-229_140e73da-c616-46af-9f13-f09ab54a324a 57664-229 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET ORAL 20130816 ANDA ANDA090710 Sun Pharmaceutical Industries, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57664-230_140e73da-c616-46af-9f13-f09ab54a324a 57664-230 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET ORAL 20130816 ANDA ANDA090710 Sun Pharmaceutical Industries, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57664-239_69bb7ebd-27a9-42a4-9757-a05a410ec2fd 57664-239 HUMAN PRESCRIPTION DRUG NITROFURANTOIN NITROFURANTOIN SUSPENSION ORAL 20120304 ANDA ANDA201355 Caraco Pharmaceutical Laboratories, Ltd. NITROFURANTOIN 25 mg/5mL Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 57664-241_0f04d6b0-8d56-4097-ace7-418d0d99f665 57664-241 HUMAN PRESCRIPTION DRUG CLOZAPINE CLOZAPINE TABLET ORAL 20050819 ANDA ANDA075713 Sun Pharmaceutical Industries, Inc. CLOZAPINE 50 mg/1 Atypical Antipsychotic [EPC] 57664-242_f7d21129-cd79-4e87-a632-ef29f7eb30c1 57664-242 HUMAN PRESCRIPTION DRUG carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077346 Caraco Pharmaceutical Laboratories, Ltd. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 57664-244_f7d21129-cd79-4e87-a632-ef29f7eb30c1 57664-244 HUMAN PRESCRIPTION DRUG carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077346 Caraco Pharmaceutical Laboratories, Ltd. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 57664-245_f7d21129-cd79-4e87-a632-ef29f7eb30c1 57664-245 HUMAN PRESCRIPTION DRUG carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077346 Caraco Pharmaceutical Laboratories, Ltd. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 57664-246_328285dd-127a-4515-8898-dfde4ac20251 57664-246 HUMAN OTC DRUG Cetirizine Hydrochloride HIVES Cetirizine Hydrochloride SOLUTION ORAL 20111201 ANDA ANDA091327 Caraco Pharmaceutical Laboratories, Ltd CETIRIZINE HYDROCHLORIDE 1 mg/mL 57664-247_f7d21129-cd79-4e87-a632-ef29f7eb30c1 57664-247 HUMAN PRESCRIPTION DRUG carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077346 Caraco Pharmaceutical Laboratories, Ltd. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 57664-263_60c4d8e0-3578-4ad3-aaad-272d1c1b5afd 57664-263 HUMAN OTC DRUG CETIRIZINE HYDROLORIDE Allergy CETIRIZINE HYDROLORIDE SOLUTION ORAL 20111201 ANDA ANDA091327 Caraco Pharmaceutical Laboratories, Ltd CETIRIZINE HYDROCHLORIDE 1 mg/mL 57664-273_695b921a-28dc-4945-9a91-b04727509529 57664-273 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20010831 ANDA ANDA075423 Caraco Pharmaceutical Laboratories, Ltd. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 57664-274_695b921a-28dc-4945-9a91-b04727509529 57664-274 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20010831 ANDA ANDA075423 Caraco Pharmaceutical Laboratories, Ltd. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 57664-275_695b921a-28dc-4945-9a91-b04727509529 57664-275 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20010831 ANDA ANDA075423 Caraco Pharmaceutical Laboratories, Ltd. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 57664-280_e317c94f-a672-4c23-a0d2-608fb8a9af3b 57664-280 HUMAN PRESCRIPTION DRUG Hydrocodone bitartrate and ibuprofen Hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20130701 ANDA ANDA091633 Sun Pharmaceutical Industries, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 10; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 57664-281_e317c94f-a672-4c23-a0d2-608fb8a9af3b 57664-281 HUMAN PRESCRIPTION DRUG Hydrocodone bitartrate and ibuprofen Hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20130701 ANDA ANDA091633 Sun Pharmaceutical Industries, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 2.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 57664-327_aa3b8a6e-c60c-47e3-8ccf-54d73c7e42aa 57664-327 HUMAN PRESCRIPTION DRUG Ticlopidine Hydrochloride Ticlopidine Hydrochloride TABLET, FILM COATED ORAL 20020926 ANDA ANDA075526 Caraco Pharmaceutical Laboratories, Ltd. TICLOPIDINE HYDROCHLORIDE 250 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 57664-345_0f04d6b0-8d56-4097-ace7-418d0d99f665 57664-345 HUMAN PRESCRIPTION DRUG CLOZAPINE CLOZAPINE TABLET ORAL 20021115 ANDA ANDA075713 Sun Pharmaceutical Industries, Inc. CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] 57664-347_0f04d6b0-8d56-4097-ace7-418d0d99f665 57664-347 HUMAN PRESCRIPTION DRUG CLOZAPINE CLOZAPINE TABLET ORAL 20021115 ANDA ANDA075713 Sun Pharmaceutical Industries, Inc. CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] 57664-357_4dec9bd6-6451-422d-aee2-dfbc55e0ca6e 57664-357 HUMAN PRESCRIPTION DRUG FLUVOXAMINE MALEATE fluvoxamine maleate TABLET ORAL 20060223 ANDA ANDA075900 Caraco Pharmaceutical Laboratories, Ltd. FLUVOXAMINE MALEATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57664-358_25c38dab-ec85-4762-bcf8-f3cbdedb0601 57664-358 HUMAN PRESCRIPTION DRUG Morphine Sulfate Oral Solution Morphine Sulfate Oral Solution SOLUTION ORAL 20120131 ANDA ANDA201011 Caraco Pharmaceutical Laboratories, Ltd. MORPHINE SULFATE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57664-359_25c38dab-ec85-4762-bcf8-f3cbdedb0601 57664-359 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20120131 ANDA ANDA201011 Caraco Pharmaceutical Laboratories, Ltd. MORPHINE SULFATE 20 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57664-361_4dec9bd6-6451-422d-aee2-dfbc55e0ca6e 57664-361 HUMAN PRESCRIPTION DRUG FLUVOXAMINE MALEATE fluvoxamine maleate TABLET ORAL 20060223 ANDA ANDA075900 Caraco Pharmaceutical Laboratories, Ltd. FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57664-362_4dec9bd6-6451-422d-aee2-dfbc55e0ca6e 57664-362 HUMAN PRESCRIPTION DRUG FLUVOXAMINE MALEATE fluvoxamine maleate TABLET ORAL 20060223 ANDA ANDA075900 Caraco Pharmaceutical Laboratories, Ltd. FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57664-368_8805a55e-c881-4dec-9e4c-b359f6292719 57664-368 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride SOLUTION ORAL 20120301 ANDA ANDA201466 Caraco Pharmaceutical Laboratories, Ltd. METHYLPHENIDATE HYDROCHLORIDE 10 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57664-369_8805a55e-c881-4dec-9e4c-b359f6292719 57664-369 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride SOLUTION ORAL 20120301 ANDA ANDA201466 Caraco Pharmaceutical Laboratories, Ltd. METHYLPHENIDATE HYDROCHLORIDE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57664-370_f6faac2f-b6d8-4055-9cbf-3c5de77cdd7b 57664-370 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20121119 ANDA ANDA090659 Caraco Pharmaceutical Laboratories, Ltd. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57664-371_f6faac2f-b6d8-4055-9cbf-3c5de77cdd7b 57664-371 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20121119 ANDA ANDA090659 Caraco Pharmaceutical Laboratories, Ltd. OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57664-377_296b7efa-cfda-4b62-915e-35da2e81cffe 57664-377 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 Sun Pharmaceutical Industries, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 57664-391_42a465c9-3cca-49aa-95bf-2658b3437218 57664-391 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET ORAL 20020103 ANDA ANDA075844 Caraco Pharmaceutical Laboratories, Ltd. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 57664-392_f7848d2b-c5f1-4e5a-91ed-c8d692efc969 57664-392 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA078627 Sun Pharmaceutical Industries, Inc. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57664-393_f7848d2b-c5f1-4e5a-91ed-c8d692efc969 57664-393 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA078627 Sun Pharmaceutical Industries, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57664-394_f7848d2b-c5f1-4e5a-91ed-c8d692efc969 57664-394 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA078627 Sun Pharmaceutical Industries, Inc. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57664-395_f7848d2b-c5f1-4e5a-91ed-c8d692efc969 57664-395 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA078627 Sun Pharmaceutical Industries, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57664-396_f7848d2b-c5f1-4e5a-91ed-c8d692efc969 57664-396 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA078627 Sun Pharmaceutical Industries, Inc. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57664-397_23dc39d0-d0db-445f-a2cc-c667444121ab 57664-397 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Caraco Pharmaceutical Laboratories, Ltd METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 57664-398_6422b9c6-fa4b-4c80-8115-6c91e20f0b13 57664-398 HUMAN PRESCRIPTION DRUG glipizide glipizide TABLET ORAL 20060807 ANDA ANDA077820 Caraco Pharmaceutical Laboratories, Ltd. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 57664-399_6422b9c6-fa4b-4c80-8115-6c91e20f0b13 57664-399 HUMAN PRESCRIPTION DRUG glipizide glipizide TABLET ORAL 20060807 ANDA ANDA077820 Caraco Pharmaceutical Laboratories, Ltd. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 57664-419_6f20cd49-8c5a-4349-9611-105bed7537a9 57664-419 HUMAN PRESCRIPTION DRUG Aspirin, Caffeine, and Dihydrocodeine Bitartrate Aspirin, Caffeine, and Dihydrocodeine Bitartrate CAPSULE ORAL 20121001 NDA AUTHORIZED GENERIC NDA011483 Caraco Pharmaceutical Laboratories, Ltd ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE 356.4; 30; 16 mg/1; mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 57664-421_752dc505-d074-4252-8508-da60cf4c2e23 57664-421 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET ORAL 20070629 ANDA ANDA078194 Caraco Pharmaceutical Laboratories, Ltd. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57664-422_752dc505-d074-4252-8508-da60cf4c2e23 57664-422 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET ORAL 20070629 ANDA ANDA078194 Caraco Pharmaceutical Laboratories, Ltd. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57664-424_752dc505-d074-4252-8508-da60cf4c2e23 57664-424 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET ORAL 20070629 ANDA ANDA078194 Caraco Pharmaceutical Laboratories, Ltd. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57664-425_752dc505-d074-4252-8508-da60cf4c2e23 57664-425 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET ORAL 20070629 ANDA ANDA078194 Caraco Pharmaceutical Laboratories, Ltd. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57664-435_23dc39d0-d0db-445f-a2cc-c667444121ab 57664-435 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Caraco Pharmaceutical Laboratories, Ltd METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 57664-437_df1ac310-9190-4b14-a4be-351931bac267 57664-437 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20030731 ANDA ANDA076363 Caraco Pharmaceutical Laboratories, Ltd. DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 57664-441_df1ac310-9190-4b14-a4be-351931bac267 57664-441 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20030731 ANDA ANDA076363 Caraco Pharmaceutical Laboratories, Ltd. DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 57664-467_4e5fe10f-cca0-4975-88a5-8f7df43ad93d 57664-467 HUMAN PRESCRIPTION DRUG meperidine hydrochloride meperidine hydrochloride TABLET ORAL 20070104 ANDA ANDA040446 Caraco Pharmaceutical Laboratories, Ltd. MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57664-471_4e5fe10f-cca0-4975-88a5-8f7df43ad93d 57664-471 HUMAN PRESCRIPTION DRUG meperidine hydrochloride meperidine hydrochloride TABLET ORAL 20070104 ANDA ANDA040446 Caraco Pharmaceutical Laboratories, Ltd. MEPERIDINE HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57664-474_23dc39d0-d0db-445f-a2cc-c667444121ab 57664-474 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Caraco Pharmaceutical Laboratories, Ltd METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 57664-477_9a2a7fa7-3bde-4095-b10d-3e7192e1048a 57664-477 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Caraco Pharmaceutical Laboratories, Ltd. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 57664-502_ddbc18ce-567c-4d74-8594-3a3194244ee2 57664-502 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20031211 ANDA ANDA076416 Sun Pharmaceutical Industries, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 57664-503_ddbc18ce-567c-4d74-8594-3a3194244ee2 57664-503 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20031211 ANDA ANDA076416 Sun Pharmaceutical Industries, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 57664-506_0f04bae5-9a58-4ec4-9366-3ed6f4577b46 57664-506 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20040115 ANDA ANDA076670 Caraco Pharmaceutical Laboratories, Ltd. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 57664-507_d0df556c-8961-412a-a424-fbdfa7a789c8 57664-507 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20041112 ANDA ANDA077032 Caraco Pharmaceutical Laboratories, Ltd. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57664-508_d0df556c-8961-412a-a424-fbdfa7a789c8 57664-508 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20041112 ANDA ANDA077032 Caraco Pharmaceutical Laboratories, Ltd. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57664-509_d0df556c-8961-412a-a424-fbdfa7a789c8 57664-509 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20041112 ANDA ANDA077032 Caraco Pharmaceutical Laboratories, Ltd. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 57664-537_446ba6b3-bea3-49c7-a17d-ca7b556788f6 57664-537 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED ORAL 20051216 ANDA ANDA077184 Sun Pharmaceutical Industries, Inc. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 57664-540_5386c311-f7be-4e91-a8ab-a569105b165f 57664-540 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20071227 ANDA ANDA077499 Caraco Pharmaceutical Laboratories, Ltd. CETIRIZINE HYDROCHLORIDE 5 mg/1 57664-541_5386c311-f7be-4e91-a8ab-a569105b165f 57664-541 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20071227 ANDA ANDA077499 Caraco Pharmaceutical Laboratories, Ltd. CETIRIZINE HYDROCHLORIDE 10 mg/1 57664-600_2475fda7-fd3b-472b-9c78-54749ba8e141 57664-600 HUMAN PRESCRIPTION DRUG ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE ORAL 20090922 ANDA ANDA040009 Caraco Pharmaceutical Laboratories Ltd. ISOSORBIDE DINITRATE 40 mg/1 57664-633_678d3921-cf6e-49a3-911f-e156be7563c0 57664-633 HUMAN PRESCRIPTION DRUG MIDAZOLAM MIDAZOLAM HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20120808 ANDA ANDA090696 Caraco Pharmaceutical Laboratories, Ltd. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 57664-634_76fa9e54-1e0d-45b6-8549-2a13e9addd10 57664-634 HUMAN PRESCRIPTION DRUG MIDAZOLAM MIDAZOLAM HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20120808 ANDA ANDA090850 Caraco Pharmaceutical Laboratories, Ltd. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 57664-641_ceeea3f6-bf3f-4863-8c45-ffa6305e84db 57664-641 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate TABLET ORAL 20030909 ANDA ANDA040480 Caraco Pharmaceutical Laboratories, Ltd. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57664-642_ceeea3f6-bf3f-4863-8c45-ffa6305e84db 57664-642 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate TABLET ORAL 20030909 ANDA ANDA040480 Caraco Pharmaceutical Laboratories, Ltd. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57664-643_ceeea3f6-bf3f-4863-8c45-ffa6305e84db 57664-643 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate TABLET ORAL 20030909 ANDA ANDA040480 Caraco Pharmaceutical Laboratories, Ltd. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57664-644_ceeea3f6-bf3f-4863-8c45-ffa6305e84db 57664-644 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate TABLET ORAL 20030909 ANDA ANDA040480 Caraco Pharmaceutical Laboratories, Ltd. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57664-645_ceeea3f6-bf3f-4863-8c45-ffa6305e84db 57664-645 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate TABLET ORAL 20030909 ANDA ANDA040480 Caraco Pharmaceutical Laboratories, Ltd. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57664-646_ceeea3f6-bf3f-4863-8c45-ffa6305e84db 57664-646 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate TABLET ORAL 20030909 ANDA ANDA040480 Caraco Pharmaceutical Laboratories, Ltd. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57664-647_ceeea3f6-bf3f-4863-8c45-ffa6305e84db 57664-647 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate TABLET ORAL 20030909 ANDA ANDA040480 Caraco Pharmaceutical Laboratories, Ltd. AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57664-650_bea768de-b1a6-4fbe-8555-6d1ac6019f16 57664-650 HUMAN PRESCRIPTION DRUG Labetalol Labetalol TABLET, FILM COATED ORAL 19990729 ANDA ANDA075215 Sun Pharmaceutical Industries, Inc. LABETALOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 57664-651_bea768de-b1a6-4fbe-8555-6d1ac6019f16 57664-651 HUMAN PRESCRIPTION DRUG Labetalol Labetalol TABLET, FILM COATED ORAL 19990729 ANDA ANDA075215 Sun Pharmaceutical Industries, Inc. LABETALOL 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 57664-652_bea768de-b1a6-4fbe-8555-6d1ac6019f16 57664-652 HUMAN PRESCRIPTION DRUG Labetalol Labetalol TABLET, FILM COATED ORAL 19990729 ANDA ANDA075215 Sun Pharmaceutical Industries, Inc. LABETALOL 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 57664-655_e852b1f9-80d8-4039-8965-a7ad470b7670 57664-655 HUMAN PRESCRIPTION DRUG Pindolol Pindolol TABLET ORAL 19940127 ANDA ANDA074063 Sun Pharmaceutical Industries, Inc. PINDOLOL 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 57664-656_e852b1f9-80d8-4039-8965-a7ad470b7670 57664-656 HUMAN PRESCRIPTION DRUG Pindolol Pindolol TABLET ORAL 19940127 ANDA ANDA074063 Sun Pharmaceutical Industries, Inc. PINDOLOL 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 57664-745_71d25795-130e-47c5-9ea0-05031ed235e5 57664-745 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20130711 ANDA ANDA077571 Sun Pharmaceutical Industries, Inc. REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 57664-747_71d25795-130e-47c5-9ea0-05031ed235e5 57664-747 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20130711 ANDA ANDA077571 Sun Pharmaceutical Industries, Inc. REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 57664-851_f33f7090-40e1-41ec-9ebd-a8f7f251bd1c 57664-851 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20130513 ANDA ANDA090867 Caraco Pharmaceutical Laboratories, Ltd. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 57664-852_f33f7090-40e1-41ec-9ebd-a8f7f251bd1c 57664-852 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20130513 ANDA ANDA090867 Caraco Pharmaceutical Laboratories, Ltd. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 57664-853_f33f7090-40e1-41ec-9ebd-a8f7f251bd1c 57664-853 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20130513 ANDA ANDA090867 Caraco Pharmaceutical Laboratories, Ltd. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 57665-001_cf871fdf-06a3-4f26-b80b-d3d9b7846072 57665-001 HUMAN PRESCRIPTION DRUG Adagen pegademase bovine INJECTION, SOLUTION INTRAMUSCULAR 20101018 NDA NDA019818 Sigma-Tau Pharmaceuticals, Inc. PEGADEMASE BOVINE 250 [iU]/mL Adenosine Deaminase [Chemical/Ingredient],Bovine Intestinal Adenosine Deaminase [EPC] 57665-101_0b5d86f9-c7c1-483d-913d-8a5865d8fc72 57665-101 HUMAN PRESCRIPTION DRUG ABELCET amphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl- INJECTION INTRAVENOUS 20101018 NDA NDA050724 Sigma-Tau Pharmaceuticals, Inc. AMPHOTERICIN B; DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-; DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- 5; 3.4; 1.5 mg/mL; mg/mL; mg/mL Lipid-based Polyene Antifungal [EPC],Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 57665-331_caae473a-b13f-11e0-a00b-0800200c9a66 57665-331 HUMAN PRESCRIPTION DRUG DepoCyt Cytarabine INJECTION, LIPID COMPLEX INTRATHECAL 20101022 NDA NDA021041 Sigma-Tau Pharmaceuticals, Inc. CYTARABINE 50 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 57670-000_e4b81e7b-6002-4c4d-b083-dab66f0751c2 57670-000 HUMAN OTC DRUG restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex ZINC OXIDE LOTION TOPICAL 20121224 OTC MONOGRAPH NOT FINAL part352 RESTORSEA INC ZINC OXIDE 20 g/100g 57677-005_08b34822-5067-4a70-90ee-337b990e5977 57677-005 HUMAN OTC DRUG Aveda Active Composition Menthol, Methyl Salicylate LIQUID TOPICAL 20110308 OTC MONOGRAPH FINAL part348 Aveda Corporation MENTHOL; METHYL SALICYLATE 1.25; 12.45 mL/50mL; mL/50mL 57677-057_21172e1e-744d-4a12-82ee-079291e3b55d 57677-057 HUMAN OTC DRUG MINERAL TINTED MOISTURIZER SPF 15 TITANIUM DIOXIDE LOTION TOPICAL 20031101 OTC MONOGRAPH NOT FINAL part352 Aveda Corporation TITANIUM DIOXIDE 4.3 mL/100mL 57677-059_b9855c21-da7e-4df5-a6a9-974efc254e03 57677-059 HUMAN OTC DRUG MINERAL TINTED MOISTURE BROAD SPECTRUM SPF 15 OIL FREE TITANIUM DIOXIDE LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 AVEDA COPORATION TITANIUM DIOXIDE .04601 g/mL 57685-7110_02a4201d-2574-4dcd-9208-d56f45b58016 57685-7110 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20130327 OTC MONOGRAPH NOT FINAL part333E APEX Sanitation, LLC ALCOHOL 540.26 g/L 57687-238_6d6aff8f-1580-40c1-8dfe-cdfbe0e6660e 57687-238 HUMAN OTC DRUG Rescue Remedy Kids HELIANTHEMUM NUMMULARIUM FLOWER, CLEMATIS VITALBA FLOWER, IMPATIENS GLANDULIFERA FLOWER, PRUNUS CERASIFERA FLOWER, and ORNITHOGALUM UMBELLATUM SOLUTION ORAL 20080301 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER 5; 5; 5; 5; 5 [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL 57687-239_495cb1cc-1128-43a3-b48f-10f3838a3c65 57687-239 HUMAN OTC DRUG Rescue Remedy HELIANTHEMUM NUMMULARIUM FLOWER, CLEMATIS VITALBA FLOWER, IMPATIENS GLANDULIFERA FLOWER, PRUNUS CERASIFERA FLOWER, and ORNITHOGALUM UMBELLATUM SOLUTION ORAL 19930809 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER 5; 5; 5; 5; 5 [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL 57687-240_96a41425-88d7-4593-821e-9cbbdfb6b0fc 57687-240 HUMAN OTC DRUG Rescue Helianthemum nummularium flower, Clematis vitalba flower, Impatiens glandulifera flower, Prunus cerasifera flower, Ornithogalum umbellatum, and Malus domestica flower CREAM TOPICAL 20091001 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; MALUS DOMESTICA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER 5; 5; 5; 5; 5; 5 [hp_X]/.5g; [hp_X]/.5g; [hp_X]/.5g; [hp_X]/.5g; [hp_X]/.5g; [hp_X]/.5g 57687-241_3f130e62-26a3-4416-ab52-8dc115059b00 57687-241 HUMAN OTC DRUG Rescue Remedy HELIANTHEMUM NUMMULARIUM FLOWER, CLEMATIS VITALBA FLOWER, IMPATIENS GLANDULIFERA FLOWER, PRUNUS CERASIFERA FLOWER, and ORNITHOGALUM UMBELLATUM SOLUTION ORAL 20050712 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER 5; 5; 5; 5; 5 [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL 57687-242_1198c697-e0f8-44c7-b7f8-03f4ad28c2b1 57687-242 HUMAN OTC DRUG Rescue Sleep HELIANTHEMUM NUMMULARIUM FLOWER, CLEMATIS VITALBA FLOWER, IMPATIENS GLANDULIFERA FLOWER, PRUNUS CERASIFERA FLOWER, ORNITHOGALUM UMBELLATUM, and AESCULUS HIPPOCASTANUM FLOWER SOLUTION ORAL 20060421 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. AESCULUS HIPPOCASTANUM FLOWER; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER 5; 5; 5; 5; 5; 5 [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL 57687-290_ffc4f904-ae8a-4da4-bafb-e2e8a84f665f 57687-290 HUMAN OTC DRUG Rescue Remedy Helianthemum nummularium flower, Clematis vitalba flower, Impatiens glandulifera flower, Prunus cerasifera flower, and Ornithogalum umbellatum GUM, CHEWING ORAL 20101101 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER 5; 5; 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57687-291_bacff1b9-f869-43df-a4c6-161a61c217d5 57687-291 HUMAN OTC DRUG Rescue Sleep Helianthemum nummularium flower, Clematis vitalba flower, Impatiens glandulifera flower, Prunus cerasifera flower, Ornithogalum umbellatum, and Aesculus hippocastanum flower CAPSULE, LIQUID FILLED ORAL 20100601 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. AESCULUS HIPPOCASTANUM FLOWER; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER 5; 5; 5; 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57687-301_097ffcfd-576f-4a6d-90ef-c61b97390b43 57687-301 HUMAN OTC DRUG Rescue Pearls HELIANTHEMUM NUMMULARIUM FLOWER, CLEMATIS VITALBA FLOWER, IMPATIENS GLANDULIFERA FLOWER, PRUNUS CERASIFERA FLOWER, AND ORNITHOGALUM UMBELLATUM CAPSULE, LIQUID FILLED ORAL 20120901 UNAPPROVED HOMEOPATHIC Nelson Bach USA Ltd CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER 5; 5; 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57687-303_3c1a04a1-ddcc-440e-a425-5dfef06ae9f2 57687-303 HUMAN OTC DRUG Rescue Pastille Lemon HELIANTHEMUM NUMMULARIUM FLOWER, CLEMATIS VITALBA TOP, IMPATIENS GLANDULIFERA FLOWER, PRUNUS CERASIFERA FLOWER, and ORNITHOGALUM UMBELLATUM LOZENGE ORAL 20140130 UNAPPROVED HOMEOPATHIC Nelson Bach USA Ltd CLEMATIS VITALBA TOP; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER 5; 5; 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57687-304_2a0cd070-0788-497a-8fc2-e092b76db68e 57687-304 HUMAN OTC DRUG Rescue Gum Spearmint Helianthemum nummularium flower, Clematis Vitalba Top, Impatiens glandulifera flower, Prunus cerasifera flower, and Ornithogalum umbellatum GUM, CHEWING ORAL 20140801 UNAPPROVED HOMEOPATHIC Nelson Bach USA Ltd CLEMATIS VITALBA TOP; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER 5; 5; 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 57687-510_cd970195-e567-4f6a-b2f6-9925f5b0a2d4 57687-510 HUMAN OTC DRUG Pure and Clear Exfoliating Wash Arnica montana, Calendula officinalis Flowering Top, and Hypericum perforatum SOLUTION TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM 6.25; 6.25; 6.25 [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL 57687-901_265c1f0b-ce44-4ad1-80b1-54c9886d72ba 57687-901 HUMAN OTC DRUG Calendula Calendula Officinalis Flowering Top CREAM TOPICAL 19920331 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/.5g 57687-906_e99fbf59-0fd6-42e8-a40e-8951ce1f13e1 57687-906 HUMAN OTC DRUG Cuts and Scrapes CALENDULA OFFICINALIS FLOWERING TOP and HYPERICUM PERFORATUM CREAM TOPICAL 19960914 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM 1; 1 [hp_X]/.25g; [hp_X]/.25g 57687-910_a32dab99-ad61-4944-bf1d-eba33b98052a 57687-910 HUMAN OTC DRUG Pure and Clear Acne Treatment ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, HYPERICUM PERFORATUM, and SULFUR GEL TOPICAL 19980211 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; SULFUR 1; 1; 1; 6 [hp_X]/.25g; [hp_X]/.25g; [hp_X]/.25g; [hp_X]/.25g 57687-919_1abceb7a-8f0e-4cf7-830e-f1669b37ed77 57687-919 HUMAN OTC DRUG H Plus Care Medicated Wipes Horse Chestnut, Calendula Officinalis Flowering Top, Collinsonia Canadensis Root, Hamamelis Virginiana Root Bark/Stem Bark, and Paeonia Officinalis Root CLOTH TOPICAL 20130401 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. CALENDULA OFFICINALIS FLOWERING TOP; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; PAEONIA OFFICINALIS ROOT 6; 6; 6; 6; 6 [hp_C]/.18mL; [hp_X]/.18mL; [hp_X]/.18mL; [hp_C]/.18mL; [hp_X]/.18mL 57687-920_5aa6b995-971d-433a-8aec-1a396dde524d 57687-920 HUMAN OTC DRUG H plus Care Hemorrhoid Horse Chestnut, Calendula Officinalis Flowering Top, Collinsonia Canadensis Root, Hamamelis Virginiana Root Bark/Stem Bark, and Paeonia Officinalis Root CREAM TOPICAL 20130401 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. CALENDULA OFFICINALIS FLOWERING TOP; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; PAEONIA OFFICINALIS ROOT 1; 1; 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57691-001_61132456-e410-41c3-b68d-0977649bdda1 57691-001 HUMAN OTC DRUG Mens Maca Root Energising Face Protector SPF15 Octinoxate Avobenzone Octisalate LOTION TOPICAL 20080301 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest AVOBENZONE; OCTINOXATE; OCTISALATE 3; 5; 3 g/100mL; g/100mL; g/100mL 57691-093_fe7d6480-7c3f-47e6-a0a2-d2943d13668b 57691-093 HUMAN OTC DRUG Seaweed Moisturizer SPF15 Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20060701 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100mL; g/100mL; g/100mL 57691-096_39dedad0-4d9c-41bb-a2f3-e81fdc9e8279 57691-096 HUMAN OTC DRUG Aloe Soothing Moisture SPF 15 Octinoxate, Octocrylene, Avobenzone LOTION TOPICAL 20061001 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest AVOBENZONE; OCTINOXATE; OCTOCRYLENE 3; 7; 6 g/100mL; g/100mL; g/100mL 57691-098_73e36415-4b7d-44e9-8742-b5fca9c42075 57691-098 HUMAN OTC DRUG Vitamin E Moisture SPF 15 Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forrest AVOBENZONE; OCTINOXATE; OCTISALATE 3; 6; 4 g/100mL; g/100mL; g/100mL 57691-107_369e0775-d4c4-404b-bd5a-66c44073b901 57691-107 HUMAN OTC DRUG 02 Moisture Foundation SPF 15 Octinoxate and Zinc Oxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; ZINC OXIDE 3.75; 3.9 mg/.5mL; mg/.5mL 57691-108_369e0775-d4c4-404b-bd5a-66c44073b901 57691-108 HUMAN OTC DRUG 03 Moisture Foundation SPF 15 Octinoxate and Zinc Oxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; ZINC OXIDE 3.75; 3.9 mg/.5mL; mg/.5mL 57691-109_369e0775-d4c4-404b-bd5a-66c44073b901 57691-109 HUMAN OTC DRUG 04 Moisture Foundation SPF 15 Octinoxate and Zinc Oxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; ZINC OXIDE 3.75; 3.9 mg/.5mL; mg/.5mL 57691-110_369e0775-d4c4-404b-bd5a-66c44073b901 57691-110 HUMAN OTC DRUG 05 Moisture Foundation SPF 15 Octinoxate and Zinc Oxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; ZINC OXIDE 3.75; 3.9 mg/.5mL; mg/.5mL 57691-112_369e0775-d4c4-404b-bd5a-66c44073b901 57691-112 HUMAN OTC DRUG 06 Moisture Foundation SPF 15 Octinoxate and Zinc Oxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; ZINC OXIDE 3.75; 3.9 mg/.5mL; mg/.5mL 57691-113_369e0775-d4c4-404b-bd5a-66c44073b901 57691-113 HUMAN OTC DRUG 07 Moisture Foundation SPF 15 Octinoxate and Zinc Oxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; ZINC OXIDE 3.75; 3.9 mg/.5mL; mg/.5mL 57691-114_1838d234-26b6-4d54-9c2e-b5d8e2ac480c 57691-114 HUMAN OTC DRUG 01 Balancing Foundation SPF 15 Octinoxate, Octisalate, and Titanium Dioxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.75; 2.5; 1.45 mg/.5mL; mg/.5mL; mg/.5mL 57691-115_1838d234-26b6-4d54-9c2e-b5d8e2ac480c 57691-115 HUMAN OTC DRUG 02 Balancing Foundation SPF 15 Octinoxate, Octisalate, and Titanium Dioxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.75; 2.5; 1.45 mg/.5mL; mg/.5mL; mg/.5mL 57691-116_1838d234-26b6-4d54-9c2e-b5d8e2ac480c 57691-116 HUMAN OTC DRUG 03 Balancing Foundation SPF 15 Octinoxate, Octisalate, and Titanium Dioxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.75; 2.5; 1.45 mg/.5mL; mg/.5mL; mg/.5mL 57691-117_1838d234-26b6-4d54-9c2e-b5d8e2ac480c 57691-117 HUMAN OTC DRUG 04 Balancing Foundation SPF 15 Octinoxate, Octisalate, and Titanium Dioxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.75; 2.5; 1.45 mg/.5mL; mg/.5mL; mg/.5mL 57691-118_1838d234-26b6-4d54-9c2e-b5d8e2ac480c 57691-118 HUMAN OTC DRUG 05 Balancing Foundation SPF 15 Octinoxate, Octisalate, and Titanium Dioxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.75; 2.5; 1.45 mg/.5mL; mg/.5mL; mg/.5mL 57691-119_1838d234-26b6-4d54-9c2e-b5d8e2ac480c 57691-119 HUMAN OTC DRUG 06 Balancing Foundation SPF 15 Octinoxate, Octisalate, and Titanium Dioxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.75; 2.5; 1.45 mg/.5mL; mg/.5mL; mg/.5mL 57691-120_1838d234-26b6-4d54-9c2e-b5d8e2ac480c 57691-120 HUMAN OTC DRUG 07 Balancing Foundation SPF 15 Octinoxate, Octisalate, and Titanium Dioxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.75; 2.5; 1.45 mg/.5mL; mg/.5mL; mg/.5mL 57691-121_1838d234-26b6-4d54-9c2e-b5d8e2ac480c 57691-121 HUMAN OTC DRUG 08 Balancing Foundation SPF 15 Octinoxate, Octisalate, and Titanium Dioxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.75; 2.5; 1.45 mg/.5mL; mg/.5mL; mg/.5mL 57691-161_369e0775-d4c4-404b-bd5a-66c44073b901 57691-161 HUMAN OTC DRUG 01 Moisture Foundation SPF 15 Octinoxate and Zinc Oxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; ZINC OXIDE 3.75; 3.9 mg/.5mL; mg/.5mL 57691-162_369e0775-d4c4-404b-bd5a-66c44073b901 57691-162 HUMAN OTC DRUG 08 Moisture Foundation SPF 15 Octinoxate and Zinc Oxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; ZINC OXIDE 3.75; 3.9 mg/.5mL; mg/.5mL 57691-170_a78ca063-b4f2-460a-8805-1f147924df69 57691-170 HUMAN OTC DRUG Vitamin C Daily Moisturizer SPF 30 Octinoxate, Octisalate, Avobenzone, Octocrylene LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 7.5; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL 57691-226_61adf106-a7bb-4895-93b0-48f1a800fc9e 57691-226 HUMAN OTC DRUG The Body Shop Pomegranate SPF 15 Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 4 g/100mL; g/100mL; g/100mL 57691-564_d29e026c-3570-4787-84f8-5741c568291a 57691-564 HUMAN OTC DRUG Satsuma Antibacterial Hand Sanitizer Alcohol GEL TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part333E The Body Shop Wake Forest ALCOHOL .734 g/mL 57691-565_33579c0f-c8ee-42ce-8209-f81e72487083 57691-565 HUMAN OTC DRUG Coconut Antibacterial Hand Sanitizer Alcohol GEL TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part333E The Body Shop Wake Forest ALCOHOL .734 g/mL 57691-566_89ea9829-df30-455c-8450-a27204d9f71c 57691-566 HUMAN OTC DRUG Mango Antibacterial Hand Sanitizer Alcohol GEL TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part333E The Body Shop Wake Forest ALCOHOL .734 g/mL 57691-567_bf4db9ab-8223-4ced-8f44-a731b783cf51 57691-567 HUMAN OTC DRUG Sweet Lemon Antibacterial Hand Sanitizer Alcohol GEL TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part333E The Body Shop Wake Forest ALCOHOL .734 g/mL 57691-568_0450d29d-695a-47c2-86c7-04f329abd606 57691-568 HUMAN OTC DRUG Strawberry Antibacterial Hand Sanitizer Alcohol GEL TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part333E The Body Shop Wake Forest ALCOHOL .734 g/mL 57691-569_b375d6bf-9046-4bbf-a223-52dbc887f90b 57691-569 HUMAN OTC DRUG Pink Grapefruit Antibacterial Hand Sanitizer Alcohol GEL TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part333E The Body Shop Wake Forest ALCOHOL .734 g/mL 57691-584_1838d234-26b6-4d54-9c2e-b5d8e2ac480c 57691-584 HUMAN OTC DRUG 09 Balancing Foundation SPF 15 Octinoxate, Octisalate, and Titanium Dioxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.75; 2.5; 1.45 mg/.5mL; mg/.5mL; mg/.5mL 57691-585_1838d234-26b6-4d54-9c2e-b5d8e2ac480c 57691-585 HUMAN OTC DRUG 10 Balancing Foundation SPF 15 Octinoxate, Octisalate, and Titanium Dioxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.75; 2.5; 1.45 mg/.5mL; mg/.5mL; mg/.5mL 57691-825_19e19bb9-9e37-47b0-a274-5268faff6af4 57691-825 HUMAN OTC DRUG Mango Antibacterial Hand Sanitizer Alcohol GEL TOPICAL 20111215 OTC MONOGRAPH NOT FINAL part333E The Body Shop, Wake Forest ALCOHOL .734 g/mL 57691-826_c54eae65-970a-4b81-b086-4e81d6215785 57691-826 HUMAN OTC DRUG Coconut Antibacterial Hand Sanitizer Alcohol GEL TOPICAL 20111215 OTC MONOGRAPH NOT FINAL part333E The Body Shop, Wake Forest ALCOHOL .734 g/mL 57698-100_ac2abb65-6239-40a8-b57b-f2238651965e 57698-100 HUMAN OTC DRUG TopiCool Pain Relief with Cats Claw Menthol GEL TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part348 TENSproducts, Inc. CAMPHOR (NATURAL); MENTHOL .4; 4.5 g/100g; g/100g 57698-100_b2c04c34-d07e-417c-a6a3-6f17bb20b24d 57698-100 HUMAN OTC DRUG TopiCool Pain Relief with Cats Claw Menthol GEL TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part348 TENSproducts, Inc. CAMPHOR (NATURAL); MENTHOL .4; 4.5 g/100g; g/100g 57702-464_14f30d68-789e-40d2-aacd-cb9f8556cc2d 57702-464 HUMAN OTC DRUG Zylast Antiseptic Ethyl Alcohol LIQUID TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333E Bocchi Laboratories Inc. ALCOHOL .76 mL/mL 57702-465_514301b8-470b-47ff-b6ab-8c20e85f36ac 57702-465 HUMAN OTC DRUG Zylast XP Antiseptic Benzethonium Chloride LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333E Bocchi Laboratories Inc. BENZETHONIUM CHLORIDE 2 mg/mL 57702-466_0455f2b3-a83a-41cd-ba1e-941ae2d70b56 57702-466 HUMAN OTC DRUG Zylast Antiseptic Surgical Scrub Ethyl Alcohol LIQUID TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333E Bocchi Laboratories Inc. ALCOHOL .76 mL/mL 57702-487_4d8bdc3d-7ff7-4c87-a8cd-ec1ef25408da 57702-487 HUMAN OTC DRUG Zylast XP Antiseptic Foaming Benzethonium Chloride SOAP TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333E Bocchi Laboratories Inc. BENZETHONIUM CHLORIDE 2 mg/mL 57707-050_b0e7be52-5d3b-4c72-bfeb-3244737afb4b 57707-050 HUMAN OTC DRUG Male Genital Desensitizer Stud 100 Lidocane SPRAY, METERED TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part348 Pound International Corp LIDOCAINE 9.6 mg/100mL 57707-058_dc1a71df-98f8-4fc7-a02c-c004896c76cc 57707-058 HUMAN OTC DRUG Premjact Male Desensitizer Pound International Lidocaine SPRAY, METERED TOPICAL 20130509 OTC MONOGRAPH NOT FINAL part348 Pound International LIDOCAINE 9.6 g/100mL 57708-888_b7674537-bbbf-48e5-bdfd-54dd4f520afd 57708-888 HUMAN OTC DRUG NIN JIOM PEI PA KOA ELM BARK SYRUP ORAL 20060901 OTC MONOGRAPH NOT FINAL part356 NIN JIOM MEDICINE MANUFACTORY (HK) LTD ELM 650 mg/5mL 57716-001_fe105b64-93dd-413b-ab1f-92c7e4077eab 57716-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040401 UNAPPROVED MEDICAL GAS Sky Oxygen OXYGEN 990 mL/L 57718-010_f4f77bb3-e9a2-4995-a2ab-27c8f85fab5c 57718-010 HUMAN OTC DRUG CORRECT ESSENTIAL ACTIVATOR Glycerin, Allantoin CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part347 MIZON CO., LTD. ALLANTOIN; GLYCERIN .6; 20 mg/100mL; mg/100mL 57718-020_3b5dca2e-0d2a-4ad6-a856-ac2f35474114 57718-020 HUMAN OTC DRUG CORRECT COMBO Glycerin CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part347 MIZON CO., LTD. GLYCERIN 7 mg/35mL 57718-030_8cc727f5-ec75-48ae-af9e-394216f98f23 57718-030 HUMAN OTC DRUG UV BOUNCE MIST OCTINOXATE, OCTISALATE SPRAY TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 MIZON CO., LTD. OCTINOXATE; OCTISALATE 3.5; 2 mg/50mL; mg/50mL 57718-040_23847ef7-b815-4e87-bf24-d8d3b28582f7 57718-040 HUMAN OTC DRUG ECO 10 Mineral Sun Pro Puff type Zinc oxide POWDER TOPICAL 20140703 OTC MONOGRAPH FINAL part347 MIZON CO., LTD. ZINC OXIDE 15.004 g/100g 57718-050_5fddac99-a171-4146-be51-fe4d64a13563 57718-050 HUMAN OTC DRUG ECO 10 Mineral Sun Pro Automatic Brush Type Zinc oxide POWDER TOPICAL 20140703 OTC MONOGRAPH FINAL part347 MIZON CO., LTD. ZINC OXIDE 15.004 g/100g 57728-0001_89343176-23ba-468d-9bf0-2a0dd9af19f4 57728-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19910131 UNAPPROVED MEDICAL GAS Atlantic Medical Inc. OXYGEN 99 L/100L 57775-000_54a707c4-7612-42fd-9a41-49c2e7e9706a 57775-000 HUMAN OTC DRUG Run Kang BZK Antiseptic Towelettes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part333A Taizhou Runkang Medical Products Co.,Ltd. BENZALKONIUM CHLORIDE .13 g/100g 57775-001_198b7161-0106-4997-82fd-c8872d47dd0b 57775-001 HUMAN OTC DRUG Run Kang Alcohol Pads - MEDIUM ISOPROPYL ALCOHOL LIQUID TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part333A Taizhou Runkang Medical Products Co.,Ltd. ISOPROPYL ALCOHOL 70 g/100g 57781-1073_0825e656-983c-4a43-b24d-68000552a185 57781-1073 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030205 UNAPPROVED MEDICAL GAS Promptcare Companies Inc. OXYGEN 99 L/100L 57782-397_feb9903f-0958-4e25-ae86-72098a33699c 57782-397 HUMAN OTC DRUG Cromolyn Sodium Cromolyn Sodium SPRAY, METERED NASAL 20010703 ANDA ANDA075702 Bausch & Lomb Incorporated CROMOLYN SODIUM 5.2 mg/mL 57804-1020_64e73ecd-d239-48d2-8430-efeae4495ead 57804-1020 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19900305 UNAPPROVED MEDICAL GAS Medic Rescue Health Care Company OXYGEN 99 L/100L 57815-011_35f33e4a-b409-4edd-8197-5f22b9d40210 57815-011 HUMAN OTC DRUG First Aid Shot Therapy Pain relief Choline Salicylate and Caffeine LIQUID ORAL 20130905 OTC MONOGRAPH NOT FINAL part343 First Aid Beverages, Inc. CAFFEINE; CHOLINE SALICYLATE 65; 500 mg/40mL; mg/40mL 57815-021_7667dca1-8624-46de-ae69-b830dbe4d6bb 57815-021 HUMAN OTC DRUG First Aid Shot Therapy Upset Stomach Relief Calcium Carbonate SOLUTION ORAL 20131101 OTC MONOGRAPH FINAL part331 First Aid Beverages, Inc. CALCIUM CARBONATE 1250 mg/34mL 57817-100_6b29ab21-944d-4229-8146-c6d182984b37 57817-100 HUMAN OTC DRUG antibacterial wet wipes Benzalkonium Chloride SWAB TOPICAL 20130329 OTC MONOGRAPH NOT FINAL part333A Hangzhou Haorun Technology CO.,LTD. BENZALKONIUM CHLORIDE .13 g/100g 57817-200_402aac36-553a-4b77-9019-e6c72786a5f6 57817-200 HUMAN OTC DRUG HAND SANITIZER ALCOHOL GEL TOPICAL 20130330 OTC MONOGRAPH NOT FINAL part333E Hangzhou Haorun Technology CO.,LTD. ALCOHOL 62 mL/100mL 57817-300_3f1e61d0-49ea-4d8d-ae28-7de4c24ae086 57817-300 HUMAN OTC DRUG SPF 30 Sunscreen OCTINOXATE OXYBENZONE Octisalate SPRAY TOPICAL 20130418 OTC MONOGRAPH NOT FINAL part352 Hangzhou Haorun Technology CO.,LTD. OCTINOXATE; OCTISALATE; OXYBENZONE 6; 5; 4 g/100g; g/100g; g/100g 57826-420_a26b2179-e2a4-4c86-a878-b1297c329bb1 57826-420 HUMAN PRESCRIPTION DRUG Haemonetics Anticoagulant Sodium Citrate TRISODIUM CITRATE DIHYDRATE SOLUTION EXTRACORPOREAL 20130110 BLA BLA980123 Haemonetics Corporation TRISODIUM CITRATE DIHYDRATE 40 mg/mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 57826-426_33ef0daa-f931-4b27-8a63-38186403d2f5 57826-426 HUMAN PRESCRIPTION DRUG Haemonetics Anticoagulant Citrate Dextrose Solution ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, DEXTROSE MONOHYDRATE SOLUTION EXTRACORPOREAL 20130110 BLA BLA980728 Haemonetics Corporation ANHYDROUS CITRIC ACID; DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 73; 245; 220 mg/mL; mg/mL; mg/mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 57826-441_9bb6ed6a-d739-4bbf-a519-8f67db3fd12b 57826-441 HUMAN PRESCRIPTION DRUG HAEMONETICS 0.9 % Sodium Chloride SODIUM CHLORIDE SOLUTION EXTRACORPOREAL 20130107 ANDA ANDA076316 Haemonetics Corporation SODIUM CHLORIDE 900 mg/100mL 57826-455_18440bae-b968-4666-b48c-cc57847d5c50 57826-455 HUMAN PRESCRIPTION DRUG Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (CP2D) CITRIC ACID MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, ANHYDROUS DEXTROSE SOLUTION EXTRACORPOREAL 20130110 BLA BLA000127 Haemonetics Corporation ANHYDROUS DEXTROSE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 464; 32.7; 22.2; 263 mg/mL; mg/mL; mg/mL; mg/mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 57826-460_de699507-ad7d-4523-922b-2b681b64edf8 57826-460 HUMAN PRESCRIPTION DRUG Haemonetics Additive Solution Formula 3 (AS-3) CITRIC ACID MONOHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM CHLORIDE, ADENINE, ANHYDROUS DEXTROSE, TRISODIUM CITRATE DIHYDRATE SOLUTION EXTRACORPOREAL 20130110 BLA BLA000127 Haemonetics Corporation ADENINE; ANHYDROUS DEXTROSE; CITRIC ACID MONOHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 3; 100; 4.2; 41; 27.6; 58.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 57826-462_94afc0e6-3b31-4ad3-bfb4-63c7101f514b 57826-462 HUMAN PRESCRIPTION DRUG Haemonetics Additive Solution Formula 3 (AS-3) CITRIC ACID MONOHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM CHLORIDE, ADENINE, ANHYDROUS DEXTROSE, TRISODIUM CITRATE DIHYDRATE SOLUTION EXTRACORPOREAL 20130107 BLA BLA000127 Haemonetics Corporation ADENINE; ANHYDROUS DEXTROSE; CITRIC ACID MONOHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 3; 100; 4.2; 41; 27.6; 58.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 57841-1305_2608fb41-083b-402b-94a0-0629fa484bb7 57841-1305 HUMAN PRESCRIPTION DRUG NOT YET DEFINED Rizatriptan Benzoate Oral Films FILM, SOLUBLE ORAL 20140531 NDA NDA205394 RedHill Biopharma Ltd. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 57841-1310_2608fb41-083b-402b-94a0-0629fa484bb7 57841-1310 HUMAN PRESCRIPTION DRUG NOT YET DEFINED Rizatriptan Benzoate Oral Films FILM, SOLUBLE ORAL 20140531 NDA NDA205394 RedHill Biopharma Ltd. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 57842-7732_ef57b280-cd8b-482d-a03f-8cc33af66e24 57842-7732 HUMAN OTC DRUG DoctorRelief Menthol, Methyl Salicylate GEL TOPICAL 20091204 OTC MONOGRAPH FINAL part348 Biotanico Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 23; 75; 38 mg/g; mg/g; mg/g 57844-009_e941ec20-b605-4e03-9002-052a52a71b12 57844-009 HUMAN PRESCRIPTION DRUG Adipex-P Phentermine Hydrochloride TABLET ORAL 19900930 ANDA ANDA085128 Teva Select Brands PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 57844-019_e941ec20-b605-4e03-9002-052a52a71b12 57844-019 HUMAN PRESCRIPTION DRUG Adipex-P Phentermine Hydrochloride CAPSULE ORAL 19900930 ANDA ANDA088023 Teva Select Brands PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 57844-105_423c6337-8520-4994-a201-8342576219ae 57844-105 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20131218 ANDA ANDA040422 Teva Select Brands AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57844-110_423c6337-8520-4994-a201-8342576219ae 57844-110 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20140203 ANDA ANDA040422 Teva Select Brands AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57844-112_423c6337-8520-4994-a201-8342576219ae 57844-112 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20131218 ANDA ANDA040422 Teva Select Brands AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57844-115_423c6337-8520-4994-a201-8342576219ae 57844-115 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20131218 ANDA ANDA040422 Teva Select Brands AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57844-117_423c6337-8520-4994-a201-8342576219ae 57844-117 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20131218 ANDA ANDA040422 Teva Select Brands AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57844-120_423c6337-8520-4994-a201-8342576219ae 57844-120 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20140211 ANDA ANDA040422 Teva Select Brands AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57844-130_423c6337-8520-4994-a201-8342576219ae 57844-130 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20140206 ANDA ANDA040422 Teva Select Brands AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 57844-151_90c0086a-b62c-4cdd-a6af-2efed69cfd4d 57844-151 HUMAN PRESCRIPTION DRUG ORAP Pimozide TABLET ORAL 20000607 NDA NDA017473 Teva Select Brands PIMOZIDE 1 mg/1 Typical Antipsychotic [EPC] 57844-187_11f4ddb4-5a05-4841-9a24-aaf18c910204 57844-187 HUMAN PRESCRIPTION DRUG ORAP pimozide TABLET ORAL 19900930 20171031 NDA NDA017473 Teva Select Brands PIMOZIDE 2 mg/1 Typical Antipsychotic [EPC] 57844-198_90c0086a-b62c-4cdd-a6af-2efed69cfd4d 57844-198 HUMAN PRESCRIPTION DRUG ORAP Pimozide TABLET ORAL 20141031 NDA NDA017473 Teva Select Brands PIMOZIDE 2 mg/1 Typical Antipsychotic [EPC] 57844-208_1f6a68d6-3594-4836-88f8-98567d1678a5 57844-208 HUMAN PRESCRIPTION DRUG GALZIN Zinc Acetate CAPSULE ORAL 19970128 NDA NDA020458 Gate Pharmaceuticals ZINC ACETATE 50 mg/1 Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 57844-215_1f6a68d6-3594-4836-88f8-98567d1678a5 57844-215 HUMAN PRESCRIPTION DRUG GALZIN Zinc Acetate CAPSULE ORAL 19970128 NDA NDA020458 Gate Pharmaceuticals ZINC ACETATE 25 mg/1 Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 57844-322_1da8d9f2-0cde-4d0b-9171-de6fc1684fe0 57844-322 HUMAN PRESCRIPTION DRUG Lofibra Fenofibrate CAPSULE ORAL 20021011 ANDA ANDA075753 Teva Select Brands FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 57844-323_1da8d9f2-0cde-4d0b-9171-de6fc1684fe0 57844-323 HUMAN PRESCRIPTION DRUG Lofibra Fenofibrate CAPSULE ORAL 20020903 ANDA ANDA075753 Teva Select Brands FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 57844-324_1da8d9f2-0cde-4d0b-9171-de6fc1684fe0 57844-324 HUMAN PRESCRIPTION DRUG Lofibra Fenofibrate CAPSULE ORAL 20020903 ANDA ANDA075753 Teva Select Brands FENOFIBRATE 200 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 57844-510_6383ca2b-10c5-44bd-bab7-439a83fdc577 57844-510 HUMAN PRESCRIPTION DRUG Adasuve loxapine AEROSOL, POWDER RESPIRATORY (INHALATION) 20140122 NDA NDA022549 Teva Select Brands LOXAPINE 10 mg/1 57844-522_94fc4b73-80d8-45f5-b734-6eeefa1b7087 57844-522 HUMAN PRESCRIPTION DRUG Purinethol Mercaptopurine TABLET ORAL 20040730 NDA NDA009053 Gate Pharmaceuticals MERCAPTOPURINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 57844-691_b2575198-b16d-4bdc-8937-d7d8e7877dbc 57844-691 HUMAN PRESCRIPTION DRUG Lofibra Fenofibrate TABLET, FILM COATED ORAL 20051123 ANDA ANDA076433 Teva Select Brands FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 57844-692_b2575198-b16d-4bdc-8937-d7d8e7877dbc 57844-692 HUMAN PRESCRIPTION DRUG Lofibra Fenofibrate TABLET, FILM COATED ORAL 20051123 ANDA ANDA076433 Teva Select Brands FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 57844-713_076304f1-9972-4f01-90db-66ed71156f1c 57844-713 HUMAN PRESCRIPTION DRUG TEV-TROPIN somatropin KIT 19950525 NDA NDA019774 Teva 57844-716_076304f1-9972-4f01-90db-66ed71156f1c 57844-716 HUMAN PRESCRIPTION DRUG TEV-TROPIN somatropin KIT SUBCUTANEOUS 20140901 NDA NDA019774 Teva 57850-0001_51938eb2-9193-4eba-a44c-986cb7195b35 57850-0001 HUMAN OTC DRUG FibroCane CALM Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis LIQUID ORAL 20131031 UNAPPROVED HOMEOPATHIC Premier Bioceuticals LLC. ACONITUM NAPELLUS; AESCULUS HIPPOCASTANUM FLOWER; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; AVENA SATIVA FLOWERING TOP; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; CYPRIPEDIUM PARVIFOLUM ROOT; HYOSCYAMUS NIGER; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA VULGARIS; STRYCHNOS IGNATII SEED; VALERIAN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57850-2000_42c04f05-6d86-4472-a603-7966390a04ea 57850-2000 HUMAN OTC DRUG Fibrocane Relief Symphytum officinale, Capsicum annuum, Ledum palustre, Colchicum autumnale, Rhododendron chrysanthum, Ruta graveolens, GEL TOPICAL 20140617 UNAPPROVED HOMEOPATHIC Premier Bioceuticals LLC CAPSICUM; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 6; 12; 3; 6; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 57881-331_9e5ba60b-985c-4721-8aec-266416b5cc53 57881-331 HUMAN PRESCRIPTION DRUG Abstral fentanyl citrate TABLET SUBLINGUAL 20130808 NDA NDA022510 Galena Biopharma, Inc. FENTANYL CITRATE 100 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57881-332_9e5ba60b-985c-4721-8aec-266416b5cc53 57881-332 HUMAN PRESCRIPTION DRUG Abstral fentanyl citrate TABLET SUBLINGUAL 20130808 NDA NDA022510 Galena Biopharma, Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57881-333_9e5ba60b-985c-4721-8aec-266416b5cc53 57881-333 HUMAN PRESCRIPTION DRUG Abstral fentanyl citrate TABLET SUBLINGUAL 20130808 NDA NDA022510 Galena Biopharma, Inc. FENTANYL CITRATE 300 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57881-334_9e5ba60b-985c-4721-8aec-266416b5cc53 57881-334 HUMAN PRESCRIPTION DRUG Abstral fentanyl citrate TABLET SUBLINGUAL 20130808 NDA NDA022510 Galena Biopharma, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57881-336_9e5ba60b-985c-4721-8aec-266416b5cc53 57881-336 HUMAN PRESCRIPTION DRUG Abstral fentanyl citrate TABLET SUBLINGUAL 20130808 NDA NDA022510 Galena Biopharma, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57881-338_9e5ba60b-985c-4721-8aec-266416b5cc53 57881-338 HUMAN PRESCRIPTION DRUG Abstral fentanyl citrate TABLET SUBLINGUAL 20130808 NDA NDA022510 Galena Biopharma, Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 57881-444_5ce1d8f5-13cc-44b2-a67e-2bf952556f59 57881-444 HUMAN PRESCRIPTION DRUG Zuplenz ondansetron FILM, SOLUBLE ORAL 20141008 NDA NDA022524 Galena Biopharma, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 57881-448_5ce1d8f5-13cc-44b2-a67e-2bf952556f59 57881-448 HUMAN PRESCRIPTION DRUG Zuplenz ondansetron FILM, SOLUBLE ORAL 20141008 NDA NDA022524 Galena Biopharma, Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 57883-401_34b8fc37-9a5e-4556-8675-3c9237ccaf75 57883-401 HUMAN PRESCRIPTION DRUG Keralac UREA CREAM TOPICAL 20110701 UNAPPROVED DRUG OTHER Brava Pharmaceuticals, LLC UREA 470 mg/g 57883-402_7e34ee67-12f2-490f-8ce0-1020d9e1ba02 57883-402 HUMAN PRESCRIPTION DRUG Plexion SULFACETAMIDE SODIUM, SULFUR LIQUID TOPICAL 20050901 UNAPPROVED DRUG OTHER Brava Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 98; 48 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 57883-403_9e195c21-8c0d-445f-8668-1fbaa08341c0 57883-403 HUMAN PRESCRIPTION DRUG Plexion SULFACETAMIDE SODIUM, SULFUR CREAM TOPICAL 20050901 UNAPPROVED DRUG OTHER Brava Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 98; 48 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 57883-404_b3a810e5-8816-4233-9817-c7df8cbfcc72 57883-404 HUMAN PRESCRIPTION DRUG Plexion SULFACETAMIDE SODIUM, SULFUR CLOTH TOPICAL 20050901 UNAPPROVED DRUG OTHER Brava Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 98; 48 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 57883-405_65212f75-df5d-4dac-ae06-469518027570 57883-405 HUMAN PRESCRIPTION DRUG Plexion SULFACETAMIDE SODIUM, SULFUR LOTION TOPICAL 20050901 UNAPPROVED DRUG OTHER Brava Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 98; 48 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 57884-2021_fa3cf0ae-bb48-4a24-98db-fe38ff14e03f 57884-2021 HUMAN PRESCRIPTION DRUG LETROZOLE LETROZOLE TABLET ORAL 20130516 ANDA ANDA202716 Jiangsu Hengrui Medicine Co., Ltd. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 57893-300_10a3482a-ae21-407c-b509-f9ee2e4efbd4 57893-300 HUMAN PRESCRIPTION DRUG SelRx SELENIUM SULFIDE SHAMPOO TOPICAL 20110831 UNAPPROVED DRUG OTHER Artesa Labs, LLC SELENIUM SULFIDE 23 mg/mL 57893-301_dd4a7eb0-1109-4060-986d-4df5d452eae3 57893-301 HUMAN PRESCRIPTION DRUG Utopic UREA CREAM TOPICAL 20110815 UNAPPROVED DRUG OTHER Artesa Labs, LLC UREA 410 mg/g 57893-302_d087f2b6-bf27-454f-97cf-3a9f3726cbee 57893-302 HUMAN PRESCRIPTION DRUG Vytone HYDROCORTISONE ACETATE, IODOQUINOL CREAM TOPICAL 20110729 UNAPPROVED DRUG OTHER Artesa Labs, LLC HYDROCORTISONE ACETATE; IODOQUINOL 19; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 57893-303_13567600-018b-400e-83f8-4bfdb72fd0c2 57893-303 HUMAN OTC DRUG Riax BENZOYL PEROXIDE AEROSOL, FOAM TOPICAL 20110815 OTC MONOGRAPH FINAL part333D Artesa Labs, LLC BENZOYL PEROXIDE 55 mg/g 57893-304_bc5176dc-04d7-4131-8ee2-f4abaae59942 57893-304 HUMAN OTC DRUG Riax BENZOYL PEROXIDE AEROSOL, FOAM TOPICAL 20110815 OTC MONOGRAPH FINAL part333D Artesa Labs, LLC BENZOYL PEROXIDE 95 mg/g 57894-030_14de0479-a781-48cf-b154-cddb682c0347 57894-030 HUMAN PRESCRIPTION DRUG REMICADE infliximab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19980824 BLA BLA103772 Janssen Biotech, Inc. INFLIXIMAB 100 mg/10mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] 57894-060_f566f5e0-b9dd-4d44-b08b-f90c0e9d7413 57894-060 HUMAN PRESCRIPTION DRUG STELARA ustekinumab INJECTION, SOLUTION SUBCUTANEOUS 20090925 BLA BLA125261 Janssen Biotech, Inc. USTEKINUMAB 45 mg/.5mL 57894-061_f566f5e0-b9dd-4d44-b08b-f90c0e9d7413 57894-061 HUMAN PRESCRIPTION DRUG STELARA ustekinumab INJECTION, SOLUTION SUBCUTANEOUS 20090925 BLA BLA125261 Janssen Biotech, Inc. USTEKINUMAB 90 mg/mL 57894-070_52339ceb-4f60-4213-8fcc-0fe22b791bcc 57894-070 HUMAN PRESCRIPTION DRUG Simponi golimumab INJECTION, SOLUTION SUBCUTANEOUS 20090425 BLA BLA125289 Janssen Biotech, Inc. GOLIMUMAB 50 mg/.5mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] 57894-071_52339ceb-4f60-4213-8fcc-0fe22b791bcc 57894-071 HUMAN PRESCRIPTION DRUG Simponi golimumab INJECTION, SOLUTION SUBCUTANEOUS 20130515 BLA BLA125289 Janssen Biotech, Inc. GOLIMUMAB 100 mg/mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] 57894-150_e9942a2f-e1fc-4424-bcfc-104e8c97d262 57894-150 HUMAN PRESCRIPTION DRUG Zytiga abiraterone acetate TABLET ORAL 20110428 NDA NDA202379 Janssen Biotech, Inc. ABIRATERONE ACETATE 250 mg/1 Cytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] 57894-350_bcb8f8d2-f4e2-4860-9a8b-8a9f3c7874d2 57894-350 HUMAN PRESCRIPTION DRUG SIMPONI ARIA golimumab SOLUTION INTRAVENOUS 20130719 BLA BLA125433 Janssen Biotech, Inc. GOLIMUMAB 50 mg/4mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] 57894-420_81252740-d7f5-4227-8bc9-f9525893d2ea 57894-420 HUMAN PRESCRIPTION DRUG SYLVANT siltuximab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140423 BLA BLA125496 Janssen Biotech, Inc. SILTUXIMAB 100 mg/1 57894-421_81252740-d7f5-4227-8bc9-f9525893d2ea 57894-421 HUMAN PRESCRIPTION DRUG SYLVANT siltuximab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140401 BLA BLA125496 Janssen Biotech, Inc. SILTUXIMAB 400 mg/1 57896-101_60798049-87f5-4b50-b1a0-8252970ee8a4 57896-101 HUMAN OTC DRUG Regular Strength Pain Relief Acetaminophen TABLET ORAL 19890101 OTC MONOGRAPH FINAL part343 Geri-Care Pharmaceutical Corp ACETAMINOPHEN 325 mg/1 57896-184_1db6ad73-0ea2-4058-ad30-a3bce050ae1d 57896-184 HUMAN OTC DRUG Gericare Artificial Tears Lubricant Eye Glycerin SOLUTION/ DROPS OPHTHALMIC 20130630 OTC MONOGRAPH FINAL part349 Gericare Pharmaceuticals GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 .002; .002; .01 mg/mg; mg/mg; mg/mg 57896-199_af3dc1f5-93c3-45d7-a514-1f58248d9aa2 57896-199 HUMAN OTC DRUG TOLNAFTATE ANTIFUNGAL TOLNAFTATE POWDER TOPICAL 20110801 OTC MONOGRAPH FINAL part333C Geri-Care Pharmaceuticals, Corp TOLNAFTATE 1 g/100g 57896-201_153c050a-109b-4f54-8f74-af6c2a857392 57896-201 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 19890101 OTC MONOGRAPH FINAL part343 Geri-Care Pharmaceutical Corp ACETAMINOPHEN 500 mg/1 57896-221_af847fe4-0b05-4940-8b41-624c22cbd303 57896-221 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 19890101 OTC MONOGRAPH FINAL part343 Geri-Care Pharmaceutical Corp ACETAMINOPHEN 500 mg/1 57896-224_a09e533c-c2fb-42f6-aea2-f4f06fe65c6c 57896-224 HUMAN OTC DRUG Extra Strength Night Time Pain Medicine Acetaminophen, Diphenhydramine HCl TABLET ORAL 19960101 OTC MONOGRAPH FINAL part341 Geri-Care Pharmaceutical Corp ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 57896-251_a4bddcbd-503d-49b0-972c-87366740263e 57896-251 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen CAPSULE, GELATIN COATED ORAL 20070601 OTC MONOGRAPH NOT FINAL part343 Geri-Care Pharmaceutical Corp ACETAMINOPHEN 500 mg/1 57896-381_cb23bb84-14ae-4cfb-b235-6b70e3a4e1e4 57896-381 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20060101 ANDA ANDA076497 Geri-Care Pharmaceutical Corp LOPERAMIDE HYDROCHLORIDE 2 mg/1 57896-391_c50fbf45-9711-4e9a-8235-0c14cc7fc127 57896-391 HUMAN OTC DRUG GERI-PECTATE VANILLA FLAVOR bismuth subsalicylate LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part335 Geri-Care Pharmaceuticals, Corp BISMUTH SUBSALICYLATE 262 mg/15mL 57896-392_3717cbb6-fba4-4afd-9896-764e7f5b3086 57896-392 HUMAN OTC DRUG PINK BISMUTH bismuth subsalicylate LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part335 Geri-Care Pharmaceuticals, Corp BISMUTH SUBSALICYLATE 262 mg/15mL 57896-396_8bbb137f-415d-421f-9cb4-97e56f506572 57896-396 HUMAN OTC DRUG GERI-PECTATE PEPPERMINT FLAVOR bismuth subsalicylate LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part335 Geri-Care Pharmaceuticals, Corp BISMUTH SUBSALICYLATE 262 mg/15mL 57896-401_12c68280-d3e2-4bd1-b28f-4d74f11a7a35 57896-401 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp DOCUSATE SODIUM 100 mg/1 57896-424_b085d98d-10dd-467a-99b1-25de81cee104 57896-424 HUMAN OTC DRUG Docusate Calcium Stool Softener CAPSULE, LIQUID FILLED ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp DOCUSATE CALCIUM 240 mg/1 57896-435_1bf05b1e-ce9a-449c-85c4-d5c5c293373b 57896-435 HUMAN OTC DRUG SORBITOL sorbitol SOLUTION RECTAL 20000101 OTC MONOGRAPH FINAL part334 Geri-Care Pharmaceuticals, Corp SORBITOL 13.5 g/15mL 57896-441_d3135762-496a-45a2-b8af-beb72f3d168a 57896-441 HUMAN OTC DRUG stimulant laxative enteric coated Bisacodyl TABLET ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp BISACODYL 5 mg/1 57896-449_84f15a32-a52d-450f-a0b3-85cd03faf947 57896-449 HUMAN OTC DRUG Fiber Laxative Calcium Polycarbophil TABLET ORAL 20040101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp CALCIUM POLYCARBOPHIL 625 mg/1 57896-451_cfb203d4-fc8a-4b85-b8fe-283ae80b850e 57896-451 HUMAN OTC DRUG Geri-kot Standardized Senna Concentrate TABLET ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp SENNOSIDES 8.6 mg/1 57896-455_26f45960-e2f7-4585-811c-dedc6f18f8d4 57896-455 HUMAN OTC DRUG Senna Plus Sennosides and Docusate Sodium TABLET ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 57896-461_8043d1a2-6243-4e62-97e8-ed3c2e7597d1 57896-461 HUMAN OTC DRUG Geri Mucil Psyllium POWDER, FOR SOLUTION ORAL 20090622 OTC MONOGRAPH NOT FINAL part334 Gericare Pharmaceuticals PSYLLIUM HUSK 3.4 g/7g 57896-489_dd87f6f3-9fe5-4b55-844b-74f714ac9da5 57896-489 HUMAN OTC DRUG POLYETHYLENE GLYCOL 3350 polyethylene glycol 3350 POWDER, FOR SOLUTION ORAL 20100902 ANDA ANDA090685 Geri-Care Pharmaceutical Corp POLYETHYLENE GLYCOL 3350 17 g/17g 57896-491_485cae8e-c22d-4263-b9bf-358e791c0325 57896-491 HUMAN OTC DRUG Geri mucil Psyllium Husks POWDER, FOR SOLUTION ORAL 20110208 OTC MONOGRAPH NOT FINAL part334 Gericare Pharmaceuticals PSYLLIUM HUSK 3.4 g/5.8g 57896-617_efe2c0eb-aacd-4bff-8f2f-c6a02d9f9b62 57896-617 HUMAN OTC DRUG GAVIS-CARE ANTACID aluminum hydroxide and magnesium carbonate SUSPENSION ORAL 20000101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceuticals, Corp ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 95; 358 mg/15mL; mg/15mL 57896-619_045bb2b0-11f9-495b-b119-33035e1d1f58 57896-619 HUMAN OTC DRUG GERI-LANTA MAXIMUM STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceuticals, Corp ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 57896-624_e68a9d1a-f937-4503-abba-91f577852466 57896-624 HUMAN OTC DRUG GERI-LANTA SUPREME CHERRY calcium carbonate, magnesium hydroxide SUSPENSION ORAL 20000101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceuticals, Corp CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 400; 135 mg/5mL; mg/5mL 57896-629_5be99f06-7367-4289-95a0-793cbab2a16b 57896-629 HUMAN OTC DRUG GERI-LANTA ANTACID ANTIGAS aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceuticals, Corp ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 57896-638_85b6d12c-a007-406b-9672-f6097fd6971b 57896-638 HUMAN OTC DRUG GERI-MOX MAX CHERRY aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20000101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceuticals, Corp ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 57896-639_5f13cf33-debd-4734-a2fd-81fede4e1afb 57896-639 HUMAN OTC DRUG GERI-MOX ANTACID ANTIGAS aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20000101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceuticals, Corp ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 57896-647_23ca07ec-cc82-4db4-a339-e8b864d36e39 57896-647 HUMAN OTC DRUG MILK OF MAGNESIA MINT magnesium hydroxide LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part334 Geri-Care Pharmaceuticals, Corp MAGNESIUM HYDROXIDE 1200 mg/15mL 57896-648_9ef9bb75-0886-4726-8dda-8742e9138c9c 57896-648 HUMAN OTC DRUG MILK OF MAGNESIA CHERRY magnesium hydroxide LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part334 Geri-Care Pharmaceuticals, Corp MAGNESIUM HYDROXIDE 1200 mg/15mL 57896-649_98a42721-9819-40e6-a466-253ecdabb661 57896-649 HUMAN OTC DRUG MILK OF MAGNESIA ORIGINAL magnesium hydroxide LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part334 Geri-Care Pharmaceuticals, Corp MAGNESIUM HYDROXIDE 1200 mg/15mL 57896-681_7ad630ba-49a5-4c5b-bf33-0c6f4554c3a2 57896-681 HUMAN OTC DRUG Geri-Dryl allergy relief Diphenhydramine HCl TABLET, COATED ORAL 20110901 OTC MONOGRAPH FINAL part336 Geri-Care Pharmaceutical Corp DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 57896-756_ea76bf14-dac7-4e9f-819f-fa863dfc96cd 57896-756 HUMAN OTC DRUG Guaiasorb DM Dextromethorphan Hydrobromide and Guaifenesin LIQUID ORAL 19950905 OTC MONOGRAPH FINAL part341 Geri-Care Pharmaceuticals, Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 57896-760_235b5cab-70e0-4e2f-9ce8-47b1381782c4 57896-760 HUMAN OTC DRUG Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080830 NDA NDA022032 Gericare Pharmaceuticals OMEPRAZOLE 20 mg/1 57896-761_89890907-6a1a-adff-000d-d077d4b5a5e4 57896-761 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130425 ANDA ANDA202194 Gericare Pharmaceuticals LANSOPRAZOLE 15 mg/1 57896-763_7067f708-81c1-4122-bc85-0fe1071de265 57896-763 HUMAN OTC DRUG CALCIUM CARBONATE CHEWABLE ANTACID calcium carbonate TABLET, CHEWABLE ORAL 20040101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceutical Corp CALCIUM CARBONATE 500 mg/1 57896-764_cab60283-7579-4c35-a7b0-7cbb48de1e61 57896-764 HUMAN OTC DRUG CALCIUM CARBONATE EXTRA STRENGTH ANTACID calcium carbonate TABLET, CHEWABLE ORAL 20040101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceutical Corp CALCIUM CARBONATE 750 mg/1 57896-778_76d5d73a-bd78-4038-aaf8-0990b2bf98ce 57896-778 HUMAN OTC DRUG Travel-Ease Meclizine HCl TABLET ORAL 20040101 OTC MONOGRAPH FINAL part336 Geri-Care Pharmaceutical Corp MECLIZINE HYDROCHLORIDE 25 mg/1 57896-784_250bc669-b6dc-4b6e-b695-3353b6d84e4e 57896-784 HUMAN OTC DRUG Allergy Relief Chlorpheniramine Maleate TABLET ORAL 20040901 OTC MONOGRAPH FINAL part341 Geri-Care Pharmaceutical Corp CHLORPHENIRAMINE MALEATE 4 mg/1 57896-785_970090a3-20c7-4884-86a3-32698763c799 57896-785 HUMAN OTC DRUG Nighttime Sleep-aid Diphenhydramine HCl TABLET ORAL 20040101 OTC MONOGRAPH FINAL part338 Geri-Care Pharmaceutical Corp DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 57896-788_0daa5b57-2988-4a79-9c1a-7aae82c2cb46 57896-788 HUMAN OTC DRUG Allergy relief Loratadine TABLET ORAL 20080101 ANDA ANDA076471 Geri-Care Pharmaceutical Corp LORATADINE 10 mg/1 57896-791_cc0cf0c5-7bdd-4a52-a40b-5615d5706b72 57896-791 HUMAN OTC DRUG SIMETHICONE Simethicone TABLET, CHEWABLE ORAL 20040101 OTC MONOGRAPH FINAL part332 Geri-Care Pharmaceuticals, Corp DIMETHICONE 80 mg/1 57896-793_a76276e4-68eb-4c4e-8373-032f22e266ae 57896-793 HUMAN OTC DRUG GERI-TUSSIN EXPECTORANT Guaifenesin LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part341 Geri-Care Pharmaceuticals, Corp GUAIFENESIN 100 mg/5mL 57896-794_ae2ef9b1-bf2a-4b2d-b8ca-99913c1da321 57896-794 HUMAN OTC DRUG MUCUS RELIEF Guaifenesin TABLET ORAL 20040101 OTC MONOGRAPH FINAL part341 Geri-Care Pharmaceuticals, Corp GUAIFENESIN 400 mg/1 57896-901_415731ec-887b-4b4a-bfb4-68ff6a2d47fd 57896-901 HUMAN OTC DRUG Aspirin NSAID Aspirin TABLET ORAL 19930804 OTC MONOGRAPH NOT FINAL part343 Geri Care Pharmaceutical ASPIRIN 325 mg/1 57896-904_2d3db263-2c53-4f91-9c50-94c32779588d 57896-904 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 19960210 OTC MONOGRAPH FINAL part343 Geri Care Pharmaceutical ASPIRIN 325 mg/1 57896-911_7bc788a3-0258-4ce5-a9ff-7ca65f33d016 57896-911 HUMAN OTC DRUG Low Strength Chewable Aspirin Aspirin TABLET, CHEWABLE ORAL 19950101 OTC MONOGRAPH NOT FINAL part343 Geri-Care Pharmaceutical Corp ASPIRIN 81 mg/1 57896-921_a66ee68f-1dc7-4ca9-84c8-52290bfed369 57896-921 HUMAN OTC DRUG Regular Strength Enteric coated aspirin Aspirin TABLET, COATED ORAL 20000701 OTC MONOGRAPH FINAL part343 Geri-Care Pharmaceutical Corp ASPIRIN 325 mg/1 57896-941_9c0f858a-2997-4fba-b700-2fb1440efd6e 57896-941 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 20040101 ANDA ANDA075010 Geri-Care Pharmaceutical Corp IBUPROFEN 200 mg/1 57896-981_55273b0f-d485-49a9-8f3b-f5222e75bb86 57896-981 HUMAN OTC DRUG Adult Low Dose Enteric Coated Aspirin Aspirin TABLET, COATED ORAL 20000701 OTC MONOGRAPH FINAL part343 Geri-Care Pharmaceutical Corp ASPIRIN 81 mg/1 57900-001_4c033307-c377-417d-aeb4-8301f6f2360c 57900-001 HUMAN OTC DRUG Assured DL-Camphor L-Menthol Methyl Salicylate PATCH TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 Zhejiang Bangli Medical Products Co., Ltd CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 1.2; 5.7; 6.3 mg/100mg; mg/100mg; mg/100mg 57900-002_9fc97756-8b39-4e37-85f1-bffdc6d3334c 57900-002 HUMAN OTC DRUG cold hot patch Menthol PATCH TOPICAL 20140318 OTC MONOGRAPH NOT FINAL part348 Zhejiang Bangli Medical Products CO.,LTD MENTHOL 5 g/100g 57902-249_3323309f-31a3-49a9-b906-d834874380b3 57902-249 HUMAN PRESCRIPTION DRUG ERWINAZE Asparaginase INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20111118 BLA BLA125359 Jazz Pharmaceuticals, Inc. ASPARAGINASE ERWINIA CHRYSANTHEMI 10000 [iU]/mL Asparaginase [Chemical/Ingredient],Asparagine-specific Enzyme [EPC] 57902-817_b548386e-33b7-450e-b6fe-ff1a83ad927c 57902-817 HUMAN PRESCRIPTION DRUG ProstaScint Kit for the Preparation of Indium In 111 Capromab Pendetide capromab pendetide KIT 19961028 BLA BLA103608 Jazz Pharmaceuticals, Inc. 57902-860_8c2bb4be-91a7-4f05-a59e-0d05f7d18332 57902-860 HUMAN PRESCRIPTION DRUG Quadramet Samarium SM 153 Lexidronam INJECTION, SOLUTION INTRAVENOUS 19970519 NDA NDA020570 Jazz Pharmaceuticals, Inc. SAMARIUM SM-153 LEXIDRONAM PENTASODIUM 50 mCi/mL 57910-100_46faf860-1949-4729-a4d7-3248e9012013 57910-100 HUMAN PRESCRIPTION DRUG Ibuprofen Immediate release Ibuprofen TABLET ORAL 20090205 ANDA ANDA078329 Shasun Pharmaceuticals Limited IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 57910-200_46faf860-1949-4729-a4d7-3248e9012013 57910-200 HUMAN PRESCRIPTION DRUG Ibuprofen Immediate release Ibuprofen TABLET ORAL 20090205 ANDA ANDA078329 Shasun Pharmaceuticals Limited IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 57910-300_46faf860-1949-4729-a4d7-3248e9012013 57910-300 HUMAN PRESCRIPTION DRUG Ibuprofen Immediate release Ibuprofen TABLET ORAL 20090205 ANDA ANDA078329 Shasun Pharmaceuticals Limited IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 57910-400_87234f8f-29b7-493f-8cd3-2e69ef44825c 57910-400 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20110404 ANDA ANDA091355 Shasun Pharmaceuticals Limited IBUPROFEN 200 mg/1 57910-401_ddeff1be-cd83-4536-b29b-3420e29d7812 57910-401 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20110428 ANDA ANDA079129 Shasun Pharmaceuticals Limited IBUPROFEN 200 mg/1 57910-402_052870b8-388e-4d0b-b8d5-ddbd106bfe93 57910-402 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20110404 ANDA ANDA091355 Shasun Pharmaceuticals Limited IBUPROFEN 200 mg/1 57910-403_a3090bcd-9963-4f6a-9c19-37175ddbd53f 57910-403 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20110328 ANDA ANDA079129 Shasun Pharmaceuticals Limited IBUPROFEN 200 mg/1 57910-404_8b783df6-fc22-4128-9cd9-79637a17f97b 57910-404 HUMAN OTC DRUG Ranitidine Ranitidine TABLET ORAL 20110628 ANDA ANDA200536 Shasun Pharmaceuticals Limited RANITIDINE HYDROCHLORIDE 150 mg/1 57910-405_51d82f41-0f1e-4eef-8410-a0e77598f025 57910-405 HUMAN OTC DRUG Ranitidine Ranitidine TABLET ORAL 20120229 ANDA ANDA201745 Shasun Pharmaceuticals Limited RANITIDINE HYDROCHLORIDE 75 mg/1 57913-2525_fe301d66-7a2a-40ff-9f68-be31eefa5c3c 57913-2525 HUMAN OTC DRUG Luminous Intensive Hand Treatment SPF 25 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Erno Laszlo, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 20; 75; 50 mg/mL; mg/mL; mg/mL 57913-2815_949958b9-b17b-48ee-abf3-74cfd85103c9 57913-2815 HUMAN OTC DRUG Luminous Intensive Decollote Treatment SPF 20 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Erno Laszlo, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 20; 75; 50 mg/mL; mg/mL; mg/mL 57913-2832_2e3ca0d0-6d4b-48f1-8bf6-fb492a49a84a 57913-2832 HUMAN OTC DRUG Phelityl Day SPF 15 Avobenzone and Octinoxate LOTION TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Erno Laszlo, Inc. AVOBENZONE; OCTINOXATE 20; 50 mg/mL; mg/mL 57913-2833_fd8d743d-1cf0-4ec1-bca9-d83a323a4ffd 57913-2833 HUMAN OTC DRUG Firmarine Moisturizer SPF 30 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Erno Laszlo, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL 57913-2834_6734af15-1a64-4b4b-a8f3-d707d871511f 57913-2834 HUMAN OTC DRUG R.E.M. Day SPF 30 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Erno Laszlo, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL 57913-2857_5efdf937-f565-433c-a797-ff98d89e8cb9 57913-2857 HUMAN OTC DRUG Oil-Control Day SPF 15 Avobenzone and Octinoxate LOTION TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Erno Laszlo, Inc. AVOBENZONE; OCTINOXATE 30; 75 mg/mL; mg/mL 57913-2869_0ecc295b-a0c9-4bef-946d-8e675d3c2e91 57913-2869 HUMAN OTC DRUG Hydraphel Day SPF15 Avobenzone and Octinoxate CREAM TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Erno Laszlo, Inc. AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL 57913-2900_a711fc5c-534b-400a-bc28-431b4bb59977 57913-2900 HUMAN OTC DRUG Absolute Finish Foundation SPF15 Octinoxate and Titanium Dioxide LOTION TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Erno Laszlo, Inc. OCTINOXATE; TITANIUM DIOXIDE 75; 20 mg/mL; mg/mL 57915-001_4919b9c9-2996-4237-a7ac-dc9ad999898a 57915-001 HUMAN OTC DRUG GERMSTARORIGINAL Isopropyl Alcohol SOLUTION TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333A Soaptronic, LLC ISOPROPYL ALCOHOL 700 g/1000g 57915-002_d128a5da-0e80-4629-b0aa-e2939e3ea565 57915-002 HUMAN OTC DRUG germstarNORO Ethyl Alcohol SOLUTION TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333E Soaptronic, LLC ALCOHOL 630 g/1000g 57915-003_bb55fe56-0711-48e2-9138-368238ef5b8b 57915-003 HUMAN OTC DRUG germstarNORO unscented Ethyl Alcohol SOLUTION TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333E Soaptronic, LLC ALCOHOL 630 g/1000g 57915-004_7cf4b946-b960-432e-a374-d66ba3d74ec4 57915-004 HUMAN OTC DRUG germstar Original unscented Isopropyl Alcohol SOLUTION TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333A Soaptronic, LLC ISOPROPYL ALCOHOL 700 g/1000g 57915-005_f37de94b-9cfc-452e-b255-836431572d15 57915-005 HUMAN OTC DRUG germstarCitrus Ethyl Alcohol SOLUTION TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333E Soaptronic, LLC ALCOHOL 630 g/1000g 57924-001_46e60c21-550e-4eb7-9572-f96fe6219750 57924-001 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 20110103 UNAPPROVED MEDICAL GAS Ross Medical Supply Co. Inc. OXYGEN 991 mL/L 57934-0103_b56662fd-14f8-4e5b-8636-97b66d7a0d1c 57934-0103 HUMAN OTC DRUG Antiperspirant Cedarwood Aluminum Chlorohydrate STICK TOPICAL 20130601 OTC MONOGRAPH FINAL part350 Every man jack ALUMINUM CHLOROHYDRATE 23 g/100g 57934-0104_b56662fd-14f8-4e5b-8636-97b66d7a0d1c 57934-0104 HUMAN OTC DRUG Antiperspirant Sandalwood Aluminum Chlorohydrate STICK TOPICAL 20130601 OTC MONOGRAPH FINAL part350 Every man jack ALUMINUM CHLOROHYDRATE 23 g/100g 57955-0001_138e991e-1005-4ab0-8f26-c4de627ab455 57955-0001 HUMAN OTC DRUG Eating Disorders Antimonium crudum, Cinchona officinalis, Ferrum metallicum, Hyoscyamus niger, Ignatia amara, Natrum muriaticum, Nux vomica, Phosphoricum acidum, Pulsatilla, Staphysagria, Thuja occidentalis, Veratrum album LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc ANTIMONY TRISULFIDE; CINCHONA OFFICINALIS BARK; DELPHINIUM STAPHISAGRIA SEED; HYOSCYAMUS NIGER; IRON; PHOSPHORIC ACID; PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0002_e21e4c7e-70b8-4660-8a29-aae15fefbb18 57955-0002 HUMAN OTC DRUG Birth Ease Aletris farinosa, Apis mellifica, Arnica montana, Belladonna, Caulophyllum thalictroides, Chamomilla, Cimicifuga racemosa, Ferrum metallicum, Kali carbonicum, Sabina, Secale cornutum, Viburnum opulus LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ALETRIS FARINOSA ROOT; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; CLAVICEPS PURPUREA SCLEROTIUM; IRON; JUNIPERUS SABINA LEAFY TWIG; MATRICARIA RECUTITA; POTASSIUM CARBONATE; VIBURNUM OPULUS BARK 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0003_b2acf975-5120-476b-8280-b5b5fdb8d7d3 57955-0003 HUMAN OTC DRUG Breast Cyst and Discomforts Aconitum napellus, Bellis perennis, Bromium, Bryonia, Chamomilla, Conium maculatum, Iodium, Phellandrium aquaticum, Phytolacca decandra, Scrophularia nodosa, Silicea LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; BELLIS PERENNIS; BROMINE; BRYONIA ALBA ROOT; CONIUM MACULATUM FLOWERING TOP; IODINE; MATRICARIA RECUTITA; OENANTHE AQUATICA FRUIT; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0005_db62ba25-39fe-4bec-9a2a-7b31638e8cb0 57955-0005 HUMAN OTC DRUG FertiCare Agnus castus, Apis mellifica, Aurum metallicum, Borax, Conium maculatum, Ferrum metallicum, Iodium, Lilium tigrinum, Lycopodium clavatum, Natrum muriatcum, Palladium metallicum, sepia LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; CHASTE TREE; CONIUM MACULATUM FLOWERING TOP; GOLD; IODINE; IRON; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; PALLADIUM; SEPIA OFFICINALIS JUICE; SODIUM BORATE; SODIUM CHLORIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0010_208c0bcd-519c-485c-8cdf-91c66bd3f584 57955-0010 HUMAN OTC DRUG Male Strengthener Agnus castus, Arnica montana, Baryta carbonica, Caladium seguinum, Kali bromatum, Lycopodium clavatum, nuphar luteum, Nux vomica, Onosmodium virginianum, Phosphoricum acidum, Picnicum acidum, Selenium metallicum LIQUID ORAL 20140421 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; BARIUM CARBONATE; CHASTE TREE; DIEFFENBACHIA SEGUINE; LYCOPODIUM CLAVATUM SPORE; NUPHAR LUTEUM ROOT; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; PICRIC ACID; POTASSIUM BROMIDE; SELENIUM; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0011_3a958480-6e94-4997-bc51-2c12ee354984 57955-0011 HUMAN OTC DRUG Prostate Strengthener Baryta carbonica, Chimaphila umbellata, Clematis erecta, Conium maculatum, Digitalis purpurea, Phosphoricum acidum, Sabal serrulata, Selenium metallicum, Staphysagria, Thuja occidentalis, Zincum metallicum LIQUID ORAL 20140331 UNAPPROVED HOMEOPATHIC King Bio Inc. BARIUM CARBONATE; CHIMAPHILA UMBELLATA; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; DIGITALIS; PHOSPHORIC ACID; SAW PALMETTO; SELENIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0015_99484848-2b08-4bb0-9f53-ffca660ebf38 57955-0015 HUMAN OTC DRUG Attention and Learning Enhancement Baryta carbonica, Calcarea carbonica, Ignatia amara, Lycopodium clavatum, Magnesia carbonica, Natrum carbonicum, Natrum muriaticum, Thuja occidentalis LIQUID ORAL 20140528 UNAPPROVED HOMEOPATHIC King Bio Inc. BARIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0020_625faf31-7d90-4a3a-a673-43a87492b4a9 57955-0020 HUMAN OTC DRUG Diarrhea Relief Aloe socotrina, Chamomilla, Cinchona officinalis, Colocynthis, Croton tigium, Cuprum arsenicosum, Gelsemium sempervirens, Ipecacuanha, Nux vomica, Phosphoricum acidum, Podophyllum peltatum, Veratrum album LIQUID ORAL 20140508 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; MATRICARIA RECUTITA; PHOSPHORIC ACID; PODOPHYLLUM; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0023_d48b2082-0844-46f6-813d-ae2859869113 57955-0023 HUMAN OTC DRUG Hemorrhoid Relief Aesculus hippocastanum, Aloe socotrina, Collinsonia canadensis, Hamamelis virginiana, Muriaticum acidum, Nux vomica, Paeonia officinalis, Ratanhia, Sepia, Sulphur LIQUID ORAL 20140604 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROCHLORIC ACID; KRAMERIA LAPPACEA ROOT; PAEONIA OFFICINALIS ROOT; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0041_9feaa4d6-265a-4414-b288-b105c69870e0 57955-0041 HUMAN OTC DRUG Acne Clear Antimonium tartaricum, Asterias rubens, Ferrum metallicum, Hepar sulphuris calcareum, Kali bromatum, Natrum muriaticum, Sanguinaria canadensis, Selenium metallicum, Sepia, Silica, Sulphur, Thuja occidentalis LIQUID ORAL 20140521 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY POTASSIUM TARTRATE; ASTERIAS RUBENS; CALCIUM SULFIDE; IRON; POTASSIUM BROMIDE; SANGUINARIA CANADENSIS ROOT; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CHLORIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0042_11b88386-dcc9-4c92-86b8-b6c96072b375 57955-0042 HUMAN PRESCRIPTION DRUG Allergies Food Chemicals Allium sativum, Anacardium orientale, Apis mellifica, Gambogia, Mercurius solubilis, Natrum carbonicum, Nitricum acidum, Nux vomica, Phosphorus, Pulsatilla, Sulphur LIQUID ORAL 20130201 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; GAMBOGE; GARLIC; MERCURIUS SOLUBILIS; NITRIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 57955-0052_1e618eca-d988-4da2-ad5c-c5b6d4819d76 57955-0052 HUMAN OTC DRUG Urinary Tract Infections Apis mellifica, Argentum nitricum, Berberis vulgaris, Cantharis, Cuprum arsenicosum, Equisetum hyemale, Lycopodium clavatum, Mercurius corrosivus, Oxalicum acidum, Plumbum metallicum, Sarsaparilla, Terebinthina LIQUID ORAL 20140521 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; CUPRIC ARSENITE; EQUISETUM HYEMALE; LEAD; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MERCURIC CHLORIDE; OXALIC ACID DIHYDRATE; SILVER NITRATE; SMILAX REGELII ROOT; TURPENTINE OIL 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0053_f9cc6254-2dfe-40c9-a8aa-a21e6edc732e 57955-0053 HUMAN OTC DRUG Lungs and Bronchial Relief Ammonium carbonicum, Antimonium arsenicicum, Antimonium tartaricum, Arsenicum album, Bromium, Carbo vegetabilis, Chlorinum, Kali carbonicum, Lobelia inflata, Stannum metallicum, Sulphuricum acidum LIQUID ORAL 20140505 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; AMMONIUM CARBONATE; ANTIMONY ARSENATE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BROMINE; CHLORINE; LOBELIA INFLATA; POTASSIUM CARBONATE; SULFURIC ACID; TIN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0055_71ace0c1-dd3e-4720-9eb8-bd1b030ec962 57955-0055 HUMAN OTC DRUG Nausea and Motion Sickness Argentum nitricum, Bryonia, Cocculus indicus, Glonoinum, Lac defloratum, Petroleum, Staphysagria, Tabacum LIQUID ORAL 20140929 UNAPPROVED HOMEOPATHIC King Bio Inc. ANAMIRTA COCCULUS SEED; BRYONIA ALBA ROOT; DELPHINIUM STAPHISAGRIA SEED; KEROSENE; NITROGLYCERIN; SILVER NITRATE; SKIM MILK; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0064_c0dde618-7891-46dd-aee3-50baf117b269 57955-0064 HUMAN OTC DRUG Artery/Cholesterol/BP Aurum metallicum, Aurum muriaticum natronatum, Baryta carbonica, Baryta muriatica, Calcarea fluorica, Ceanothus americanus, Cholesterinum, Glonoinum, Plumbum iodatum, Strophanthus hispidus LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CALCIUM FLUORIDE; CEANOTHUS AMERICANUS LEAF; CHOLESTEROL; GOLD; LEAD IODIDE; NITROGLYCERIN; SODIUM TETRACHLOROAURATE; STROPHANTHUS HISPIDUS SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0065_10cf2ef3-2b83-4574-8dea-56dea9c8d39b 57955-0065 HUMAN OTC DRUG Heart Regularity Apocynum cannabinum, Baryta carbonica, Cactus grandiflorus, Convallaria majalis, Digitalis purpurea, Gelsemium sempervirens, Glonoinum, Naja tripudians, Phosphorus, Spigelia anthelmia, Spongia tosta LIQUID ORAL 20140513 UNAPPROVED HOMEOPATHIC King Bio Inc. APOCYNUM CANNABINUM ROOT; BARIUM CARBONATE; CONVALLARIA MAJALIS; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0068_075673dd-d7cb-4a26-ba2c-aa3d7122d03d 57955-0068 HUMAN OTC DRUG Gallplex Berberis vulgaris, Bryonia, Carduus marianus, Chelidonium majus, Cholesterinum, Cinchona officinalis, Colocynthis, Dioscorea villosa, Lycopodium clavatum, Natrum sulphuricum LIQUID ORAL 20140718 UNAPPROVED HOMEOPATHIC King Bio Inc. BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; SODIUM SULFATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0070_e37ecaf9-0777-4adc-98ba-40af277f59bd 57955-0070 HUMAN OTC DRUG Bone Strengthener Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Equisetum hyemale, Hekla lava, Phosphorus, silicea LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. CALCIUM FLUORIDE; EQUISETUM HYEMALE; HEKLA LAVA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0076_99db1291-1eaf-4ab9-a191-e86706b4bd97 57955-0076 HUMAN PRESCRIPTION DRUG Yeast Freee Abies nigra, Antimonium crudum, Asafoetida, Baptisia tinctoria, Borax, Candida albicans, Lachesis mutus, Phosphoricum acidum, Phytolacca decandra, Pulsatilla, Sticta Plumonaria, Sulphur, Thuja occidentalis LIQUID ORAL 20130226 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY TRISULFIDE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; CANDIDA ALBICANS; LACHESIS MUTA VENOM; LOBARIA PULMONARIA; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PICEA MARIANA RESIN; PULSATILLA VULGARIS; SODIUM BORATE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 57955-0081_5a4b2f45-0da4-427a-9c60-21a19940d053 57955-0081 HUMAN PRESCRIPTION DRUG Acute Viro Reliever Aconitum napellus, Belladonna, Chininum sulphuricum, Ferrum phosphoricum, Hepar sulphuris calcareum, Mercurius corrosivus, Natrum muriaticum, Nux vomica, Phosphorus, Pulsatilla, Sarcolacticum acidum, Sulphur LIQUID ORAL 20121212 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; CALCIUM SULFIDE; FERROSOFERRIC PHOSPHATE; LACTIC ACID, L-; MERCURIC CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; QUININE SULFATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Antimalarial [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 57955-0088_d225cdf8-6cf9-40f5-bb22-6c2a5880bf05 57955-0088 HUMAN OTC DRUG Chronic Viro Reliever Boletus luridus, Bryonia, Crotalus horridus, Echinacea purpurea, Gelsemium sempervirens, Gentiana lutea, Kali phosphoricum, Lachesis mutus, Mercurius vivus, Muriaticum acidum, Natrum sulphuricum, Nitricum acidum, Phosphoricum acidum, Veratrum album LIQUID ORAL 20140328 UNAPPROVED HOMEOPATHIC King Bio Inc. BOLETUS LURIDUS FRUITING BODY; BRYONIA ALBA ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA PURPUREA; GELSEMIUM SEMPERVIRENS ROOT; GENTIANA LUTEA ROOT; HYDROCHLORIC ACID; LACHESIS MUTA VENOM; MERCURY; NITRIC ACID; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SODIUM SULFATE; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0094_ebae2ebd-7319-449d-b4ac-164687ff4f3a 57955-0094 HUMAN OTC DRUG Bladder Formula Aesculus hippocastanum, apis mellifica, Benzoicum acidum, Causticum, Equisetum hyemale, Lycopodium clavatum, Phosphorus, Plantago major, Rhus aromatica, Sepia LIQUID ORAL 20140430 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; HORSE CHESTNUT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0095_42c413d9-4a30-44df-a39b-586ce7716ca6 57955-0095 HUMAN OTC DRUG PMS Relief Apis mellifica, Chamomilla, Cimicifuga racemosa, Cyclamen europaeum, Helonias dioica, Hypericum perforatum, Hypothalamus, Ignatia amara, Kali carbonicum, Lac caninum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Oophorinum, Platinum metallicum, Sepia LIQUID ORAL 20140611 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; BLACK COHOSH; BOS TAURUS HYPOTHALAMUS; CANIS LUPUS FAMILIARIS MILK; CHAMAELIRIUM LUTEUM ROOT; CYCLAMEN PURPURASCENS TUBER; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PLATINUM; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA OVARY 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0100_e3b51725-728c-4dba-89bc-183b46c4b120 57955-0100 HUMAN OTC DRUG Hydration Aloe socotrina, Apis mellifica, Avena sativa, Carbo vegetabilis, Equisetum hyemale, Gelsemium sempervirens, Pulsatilla, Selenium metallicum, Taraxacum officinale LIQUID ORAL 20140331 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; ALOE; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; EQUISETUM HYEMALE; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA VULGARIS; SELENIUM; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0101_b21a299f-6d0e-4478-bda3-c6ad7d629998 57955-0101 HUMAN OTC DRUG Acute Viro Reliever Aconitum napellus, Belladonna, Chininum sulphuricum, Ferrum phosphoricum, Hepar sulphuris calcareum, Mercurius corrosivus, Natrum muriaticum, Nux vomica, Phosphorus, Pulsatilla, Sarcolacticum acidum, Sulphur LIQUID ORAL 20140402 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; CALCIUM SULFIDE; FERROSOFERRIC PHOSPHATE; LACTIC ACID, L-; MERCURIC CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; QUININE SULFATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0116_b551e41d-8db7-4e70-aa64-b3bbe3298a94 57955-0116 HUMAN OTC DRUG Poison Ivy and Oak Relief Anacardium occidentale, clematis erecta, Croton tiglium, Cypripedium pubescens, Echinacea purpurea, Erechtites hieracifolia, Graphites Grindelia, Histaminum hydrochloricum, Mezereum, Rhus toxicodendron, Urtica urens LIQUID ORAL 20140527 UNAPPROVED HOMEOPATHIC King Bio Inc. ANACARDIUM OCCIDENTALE FRUIT; CLEMATIS RECTA FLOWERING TOP; CROTON TIGLIUM SEED; CYPRIPEDIUM PARVIFOLUM ROOT; DAPHNE MEZEREUM BARK; ECHINACEA PURPUREA; ERECHTITES HIERACIIFOLIUS; GRAPHITE; GRINDELIA HIRSUTULA WHOLE; HISTAMINE DIHYDROCHLORIDE; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0118_03fe8a76-4c0c-4a36-8799-24889125138c 57955-0118 HUMAN OTC DRUG Wounds Recovery Arnica montana, Bellis perennis, Bryonia, Calendula officinalis, Carbo vegetabilis, Hamamelis virginiana, Hepar sulphuris calcareum, Hypericum perforatum, Millefolium, Rhus toxicodendron, Staphysagria, Symphytum officinale, Veratrum album LIQUID ORAL 20140528 UNAPPROVED HOMEOPATHIC King Bio Inc. ACHILLEA MILLEFOLIUM; ACTIVATED CHARCOAL; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0126_b03eecf3-a213-434c-a44f-09b408c6ed2f 57955-0126 HUMAN OTC DRUG Bio Reset/Jet Lag Cocculus indicus, Colchicum autumnale, gelsemium sempervirens, Juniperus communis, Kali carbonicum, Kali phosphoricum, Nux vomica, Passiflora incarnata, Phosphoricum acidum, Phosphorus LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ANAMIRTA COCCULUS SEED; COLCHICUM AUTUMNALE BULB; GELSEMIUM SEMPERVIRENS ROOT; JUNIPER BERRY; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0128_b064216f-0cc3-4b6e-9a6f-644c3baee7ed 57955-0128 HUMAN OTC DRUG Appetite Enhancer Alumina, Antimonium crudum, Arsenicum album, asarum europaeum, Baptisia tinctoria, Carbolicum acidum, Chininum arsenicosum, Cocculus indicus, Lecithin, Picricum acidum, Pulsatilla, Rhus toxicodendron, Silicea, Sulphur LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; ANAMIRTA COCCULUS SEED; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ASARUM EUROPAEUM; BAPTISIA TINCTORIA ROOT; EGG PHOSPHOLIPIDS; PHENOL; PICRIC ACID; PULSATILLA VULGARIS; QUININE ARSENITE; SILICON DIOXIDE; SULFUR; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0134_bebc4362-f7c5-4f84-a35b-1016cfeca32c 57955-0134 HUMAN OTC DRUG Sinus Relief Apis mellifica, Baptisia tinctoria, Colocynthis, Hepar sulphuris calcareum, Histaminum hydrochloricum, Hydrastis canadensis, Ignatia amara, Kali bichromicum, Lemna minor, Mercurius vivus, Pulsatilla, Rhus toxicodendron, Sabadilla, Thuja occidentalis LIQUID ORAL 20131217 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; CITRULLUS COLOCYNTHIS FRUIT PULP; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; LEMNA MINOR; MERCURY; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; STRYCHNOS IGNATII SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0142_152b927b-7f07-4f5a-9027-c299642b520b 57955-0142 HUMAN PRESCRIPTION DRUG Childrens Growth and Development Alfalfa, Avena sativa, Baryta carbonica, Baryta iodata, Baryta muriatica, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Lycopodium clavatum and Thuja occidentalis LIQUID ORAL 20130228 UNAPPROVED HOMEOPATHIC King Bio Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; BARIUM IODIDE; CALCIUM FLUORIDE; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; THUJA OCCIDENTALIS LEAFY TWIG; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 57955-0159_167af674-4640-4c40-b11a-625334598a0d 57955-0159 HUMAN PRESCRIPTION DRUG Childrens Fever Reliever Aceticum acidum, Aconitum napellus, Aesculus hippocastanum, Agaricus muscarius, Baptisia tinctoria, Belladonna, Bryonia, Chamomilla, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Pulsatilla, Rhus toxicodendron, Sambucus nigra, Sulphur, Veratrum Viride LIQUID ORAL 20130301 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETIC ACID; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; HORSE CHESTNUT; MATRICARIA RECUTITA; PULSATILLA VULGARIS; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; TOXICODENDRON PUBESCENS LEAF; VERATRUM VIRIDE ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0161_845e5b05-c820-4e09-9762-f51127f81575 57955-0161 HUMAN OTC DRUG Back, Neck, Muscle and Joint Injuries Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Cimicifuga racemosa, Cabaltum metallicum, Gnaphalium polycephalum, Hypericum perforatum, Kali carbonicum, Kali phosphoricum, Magnesia phosphorica, Oxalicum acidum, Phosphorus, Rhus toxicodendron, Ruta graveolens, Zincum metallicum LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; COBALT; HORSE CHESTNUT; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0162_b33cc5a1-1afc-43c3-9efe-eb89a5bd4010 57955-0162 HUMAN OTC DRUG Arthritis and Joint Relief Actaea spicata, Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Causticum, Cimicifuga racemosa, Formicum acidum, Hypericum perforatum, Ledum palustre, Lithium carbonicum, Magnesia phosphorica, Phytolacca decandra, Pulsatilla, Rhododendron chrysanthum, Rhus toxicodendron, Ruta graveolens, Salicylicum acidum, Sepia, Zincum metallicum LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTAEA SPICATA ROOT; ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAUSTICUM; FORMIC ACID; HORSE CHESTNUT; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0165_3eb144e7-254b-4836-b9e2-fe383e0cb33b 57955-0165 HUMAN OTC DRUG Colds Sores and Herpes Apis mellifica, Arsenicum album, Borax, Capsicum annuum, Graphites, Mentha piperita, Mezereum, Natrum muriaticum, Nux vomica, Petroleum, Ranunculus bulbosus, Rhus toxicodendron LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc APIS MELLIFERA; ARSENIC TRIOXIDE; CAPSICUM; DAPHNE MEZEREUM BARK; GRAPHITE; KEROSENE; MENTHA PIPERITA; RANUNCULUS BULBOSUS; SODIUM BORATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0170_cf2df145-9e8e-42b4-9423-fe51019cc736 57955-0170 HUMAN OTC DRUG Climate Adaptation Cold and Damp Aranea diadema, Calcarea carbonica, Carbo animalis, Dulcamara, Formica rufa, Hypericum perforatum, Hypothalamus, Nux moschata, Oleum morrhuae, Phytolacca decandra, Polygonum punctatum, Sanguinaria canadensis, Thyroidinum, Urtica urens, Veratrum album LIQUID ORAL 20130925 UNAPPROVED HOMEOPATHIC King Bio Inc. ARANEUS DIADEMATUS; BOS TAURUS HYPOTHALAMUS; CARBO ANIMALIS; COD LIVER OIL; FORMICA RUFA; HYPERICUM PERFORATUM; NUTMEG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PERSICARIA PUNCTATA; PHYTOLACCA AMERICANA ROOT; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA TOP; THYROID, UNSPECIFIED; URTICA URENS; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0172_37ae5a4f-d616-40d8-b537-7547f67e9b7c 57955-0172 HUMAN OTC DRUG Climate Adaptation Hot and Dry Antimonium crudum, Baptisia tinctoria, Chamomilla, Fagopyrum esculentum, Glonoinum, Hypothalamus, Natrum carbonicum, Natrum muriaticum, Podophyllinum, Populus candicans, Selenium metallicum, Thyroidinum LIQUID ORAL 20130925 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY TRISULFIDE; BAPTISIA TINCTORIA ROOT; BOS TAURUS HYPOTHALAMUS; FAGOPYRUM ESCULENTUM; MATRICARIA RECUTITA; NITROGLYCERIN; PODOPHYLLUM RESIN; POPULUS BALSAMIFERA LEAF BUD; SELENIUM; SODIUM CARBONATE; SODIUM CHLORIDE; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0173_8bdda7ac-ce6e-4c73-83a9-ff3904bb5740 57955-0173 HUMAN OTC DRUG Climate Adaptation Hot and Humid Aloe socotrina, Bromium, Carboneum sulphuratum, Colchicum autumnale, Elaterium, Gelsemium sempervirens, Hamamelis virginiana, Hypothalamus, Iodium, Ipecacuanha, Natrum sulphuricum, Piper nigrum, Thyroidinum LIQUID ORAL 20131119 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; ALOE; BOS TAURUS HYPOTHALAMUS; BROMINE; CARBON DISULFIDE; COLCHICUM AUTUMNALE BULB; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; GREEN PEPPERCORN; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; IODINE; IPECAC; SODIUM SULFATE; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0212_5eb32b0d-8c37-4a08-9cee-43150bad2429 57955-0212 HUMAN PRESCRIPTION DRUG CS-Brain Arsenicum album, Arsenicum iodatum, Baryta carbonica, Calcarea carbonica, Carbo animalis, Kreosotum, Lachesis mutus, Phosphorus, Silicea LIQUID ORAL 20130301 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; CARBO ANIMALIS; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SILICON DIOXIDE; WOOD CREOSOTE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0216_0150a554-f59d-43d6-8cae-594e7f81f376 57955-0216 HUMAN OTC DRUG CS-Ovary Apis mellifica, Arsenicum album, Aurum iodatum, Baryta muriatica, Colocynthis, Conium maculatum, Iodium, Lachesis mutus, Lycopodium clavatum, Naja tripudians, Oophorinum, Platinum metallicum, Podophyllum peltatum LIQUID ORAL 20140113 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; BARIUM CHLORIDE DIHYDRATE; CITRULLUS COLOCYNTHIS FRUIT PULP; CONIUM MACULATUM FLOWERING TOP; GOLD MONOIODIDE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; NAJA NAJA VENOM; PLATINUM; PODOPHYLLUM; SUS SCROFA OVARY 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0222_272939c4-553a-46f6-a460-2a7cdb0045b8 57955-0222 HUMAN OTC DRUG CS Brain Arsenicum album, Arsenicum iodatum, Baryta carbonica, Calcarea carbonica, Carbo animalis, Kreosotum, Lachesis mutus, Phosphorus, Silicea LIQUID ORAL 20140331 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; CARBO ANIMALIS; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SILICON DIOXIDE; WOOD CREOSOTE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0242_f27c12c4-9752-4ff8-8cbc-a717f29ea02a 57955-0242 HUMAN OTC DRUG Hydration Aloe socotrine, Apis mellifica, Avena sativa, Carbo vegetabilis, Equisetum hyemale, Gelsemium sempervirens, Pulsatilla, Selenium metallicum, Taraxacum officinale LIQUID ORAL 20140227 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; ALOE; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; EQUISETUM HYEMALE; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA VULGARIS; SELENIUM; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0277_bce8f15e-8405-443e-aed5-d1f624b3bf91 57955-0277 HUMAN OTC DRUG M3 Metabolic Mineral Modulator Aqua marina, Calcarea carbonica, Calcarea fluorica, Guaiacum, Hekla lava, Lecithin, Parathormonum, Pyridoxinum hydrochloricum LIQUID ORAL 20130927 UNAPPROVED HOMEOPATHIC King Bio Inc. CALCIUM FLUORIDE; EGG PHOSPHOLIPIDS; GUAIAC; HEKLA LAVA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PARATHYROID HORMONE; PYRIDOXINE HYDROCHLORIDE; SODIUM CHLORIDE 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0288_250577e6-1a73-4e1c-997c-b4e7f76a2a20 57955-0288 HUMAN OTC DRUG Environmental Adaptation Cold and Dry Aconitum napellus, Agaricus muscarius, Asarum europaeum, Aurum metallicum, Bryonia, Camphora, Causticum, Hepar sulphuris calcareum, Hypothalamus, Kali carbonicum, Petroleum, Secale cornutum, Sepia, Thyroidinum LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; ASARUM EUROPAEUM; BOS TAURUS HYPOTHALAMUS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAMPHOR (NATURAL); CAUSTICUM; CLAVICEPS PURPUREA SCLEROTIUM; GOLD; KEROSENE; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0305_ca44f63d-749f-4062-8fc7-ac3158825310 57955-0305 HUMAN OTC DRUG SYC Miasm Aconitum napellus, Cantharis, Gelsemium sempervirens, Natrum sulphuricum, Picricum acidum, Pulsatilla, Sepia, Staphysagria LIQUID ORAL 20140120 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; LYTTA VESICATORIA; PICRIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM SULFATE 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0321_bfea8445-cae3-46be-84c9-8b58456e9bad 57955-0321 HUMAN OTC DRUG Upper GI Restoration Aceticum acidum, Agaricus muscarius, Aloe socotrina, Antimonium crudum, Argentum nitricum, Carbo vegetabilis, Carduus marianus, Chelidonium majus, Chenopodium anthelminticum, Cinchona officinalis, Graphites, Ipecacuanha, Lac defloratum, Mentha piperita, Nux vomica, Secale cornutum, Tanacetum vulgare, Teucrium marum, Zingiber officinale LIQUID ORAL 20131022 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETIC ACID; ACTIVATED CHARCOAL; ALOE; AMANITA MUSCARIA FRUITING BODY; ANTIMONY TRISULFIDE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CLAVICEPS PURPUREA SCLEROTIUM; DYSPHANIA AMBROSIOIDES; GINGER; GRAPHITE; IPECAC; MENTHA PIPERITA; SILVER NITRATE; SILYBUM MARIANUM SEED; SKIM MILK; STRYCHNOS NUX-VOMICA SEED; TANACETUM VULGARE TOP; TEUCRIUM MARUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0420_22b9f571-1f43-40b9-b809-0a0391b3b86a 57955-0420 HUMAN OTC DRUG EMF Detox Adrenalinum, Argentum iodatum, Cadmium sulphuricum, Capsicum Annuum, Fucus vesiculosus, Iodium, Kali iodatum, Ledum palustre, Lycopodium clavatum, Phosphoricum acidum, Phosphorus, Pulsatilla, Radium bromatum Strontium carbonicum, Thyroidinum, Uranium nitricum, X-ray LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ALCOHOL, X-RAY EXPOSED (1000 RAD); CADMIUM SULFATE; CAPSICUM; EPINEPHRINE; FUCUS VESICULOSUS; IODINE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM IODIDE; PULSATILLA VULGARIS; RADIUM BROMIDE; SILVER IODIDE; STRONTIUM CARBONATE; THYROID, UNSPECIFIED; URANYL NITRATE HEXAHYDRATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0722_c207cf06-7c37-4e75-b3f1-000966f1173f 57955-0722 HUMAN OTC DRUG Dairy Intolerances Aethusa cynapium, Anacardium orientale, Apium graveolens, Calcarea carbonica, Gambogia, Histaminum hydrochloricum, Hydrastis canadensis, Lac defloratum, Lac vaccinum, Pulsatilla, Sepia, Sulphur LIQUID ORAL 20131125 UNAPPROVED HOMEOPATHIC King Bio Inc. AETHUSA CYNAPIUM; CELERY SEED; COW MILK; GAMBOGE; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SKIM MILK; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0723_007fc434-6d87-4168-9d32-5e33a1c5f853 57955-0723 HUMAN OTC DRUG Eggs and Meats Intolerances Calcarea carbonica, Causticum, Chloramphenicolum, Colchicum autumnale, Gambogia, Histaminum hydrochloricum, Hydrastis canadensis, Ichthyolum, Lecithin, Ova tosta, Ovi gallinae pellicula, Pulsatilla, Pyrogenium LIQUID ORAL 20131119 UNAPPROVED HOMEOPATHIC King Bio Inc. CAUSTICUM; CHLORAMPHENICOL; COLCHICUM AUTUMNALE BULB; EGG PHOSPHOLIPIDS; EGG SHELL MEMBRANE; EGG SHELL, COOKED; GAMBOGE; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; ICHTHAMMOL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; RANCID BEEF 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0724_d8986a56-8c38-45c4-bc56-cb699259d390 57955-0724 HUMAN OTC DRUG Grains and Gluten Intolerances Arsenicum album, Bryonia, Histaminum hydrochloricum, Hydrastis canadensis, Lycopodium clavatum, Natrum muriaticum, Pulsatilla, Sabadilla, Secale cornutum, Sulphur LIQUID ORAL 20131119 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CLAVICEPS PURPUREA SCLEROTIUM; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0727_b095088b-fcab-4de8-861b-2284abb23c04 57955-0727 HUMAN OTC DRUG Food Intolerances Aethusa cynapium, Calcarea carbonica, Cucurbita pepo, semen, Gambogia, Histaminum hydrochloricum, Hydrastis canadensis, Lycopodium clavatum, Natrum carbonicum, Nitricum acidum, Nux vomica, Ovi gallinae pellicula, Phosphorus, Pulsatilla, Sulphur LIQUID ORAL 20140623 UNAPPROVED HOMEOPATHIC King Bio Inc. AETHUSA CYNAPIUM; EGG SHELL MEMBRANE; GAMBOGE; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; PUMPKIN SEED; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0758_9f07d14a-6dd5-47e3-bf7c-16eb81099bf7 57955-0758 HUMAN OTC DRUG Childrens Ear Relief Aconitum napellus, Allium cepa, Apis mellifica, Belladonna, Calcarea carbonica, Capsicum annuum, Causticum, Chamomilla, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali muriaticum, Mercurius dulcis, Mercurius solubilis, Plantago major, Silicea LIQUID ORAL 20140331 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ATROPA BELLADONNA; CALCIUM SULFIDE; CALOMEL; CAPSICUM; CAUSTICUM; FERROSOFERRIC PHOSPHATE; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; ONION; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PLANTAGO MAJOR; POTASSIUM CHLORIDE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0815_851a8fbb-fe12-4932-8396-97ea35288063 57955-0815 HUMAN OTC DRUG Mole Remover Carbo vegetabilis, Graphites, Lycopodium clavatum, Phytolacca decandra, Thuja occidentalis LIQUID TOPICAL 20140813 UNAPPROVED HOMEOPATHIC King Bio Inc. CARBO ANIMALIS; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL 57955-0816_db4b4dae-519f-4b72-97e9-233613e7474b 57955-0816 HUMAN OTC DRUG Scar Remover Arnica montana, Calcarea fluorica, Calcarea phosphorica, Calendula officinalis, Graphites, Hydrofluoricum acidum, Phytolacca decandra, Sabina, Silicea, Thiosinaminum, Thuja occidentalis LIQUID ORAL 20140318 UNAPPROVED HOMEOPATHIC King Bio Inc. ALLYLTHIOUREA; ARNICA MONTANA; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; GRAPHITE; HYDROFLUORIC ACID; JUNIPERUS SABINA LEAFY TWIG; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL 57955-0817_bb821bc6-eb47-4d9e-a2a1-c24eb82b185e 57955-0817 HUMAN OTC DRUG Cherry Angioma Remover Benzoicum acidum, Calcarea carbonica, Calcarea iodata, Iodium, Phosphoricum acidum, Phosphorus, Sulphuricum acidum LIQUID TOPICAL 20140805 UNAPPROVED HOMEOPATHIC King Bio Inc. BENZOIC ACID; CALCIUM IODIDE; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL 57955-0980_aa4d22dc-f403-43de-9c16-0c423a80a64b 57955-0980 HUMAN OTC DRUG Burnout Alfalfa, Ambra grisea, Anacardium orientale, Argentum nitricum, Aurum metallicum, Avena sativa, Caladium seguinum, Calcarea carbonica, Cocculus indicus, Gelsemium sempervirens, Ignatia amara, Kali phosphoricum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Phosphoricum acidum, Phosphorus, Selenium metallicum, Sepia, Silicea, Sulphur LIQUID ORAL 20131009 UNAPPROVED HOMEOPATHIC King Bio Inc. ALFALFA; AMBERGRIS; ANAMIRTA COCCULUS SEED; AVENA SATIVA FLOWERING TOP; DIEFFENBACHIA SEGUINE; GELSEMIUM SEMPERVIRENS ROOT; GOLD; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-0981_cafd5689-28b7-450d-8d8a-a463a08429e4 57955-0981 HUMAN OTC DRUG Adrenal Burnout Adrenalinum, Aesculus hippocastanum, flos, Alfalfa, Ambra grisea, Anacardium orientale, argentum nitricum, Avena sativa, Calcarea carbonica, Carboneum oxygenisatum, carpinus betulus, flos, Citricum acidum, Gelsemium sempervirens, Hypothalamus, Kali phosphoricum, Lecithin, Natrum muriaticum, Olea europaea, flos, Phosphoricum acidum, Pituitarum posterium, Selenium metallicum, Sepia, Silicea, Thyroidinum LIQUID ORAL 20141210 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS HIPPOCASTANUM FLOWER; ALFALFA; AMBERGRIS; ANHYDROUS CITRIC ACID; AVENA SATIVA FLOWERING TOP; BOS TAURUS HYPOTHALAMUS; CARBON MONOXIDE; CARPINUS BETULUS FLOWERING TOP; EGG PHOSPHOLIPIDS; EPINEPHRINE; GELSEMIUM SEMPERVIRENS ROOT; OLEA EUROPAEA FLOWER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1010_2855bf30-2738-4a3c-9d40-396513a7d3e2 57955-1010 HUMAN PRESCRIPTION DRUG Physical Anger Allium sativum, Belladonna, Calendula officinalis, Cantharis, Cichorium intybus, flos, Cimex Lectularius, Fagus sylvatica, flos, Gallicum acidum, Hepar sulphuris calcareum, Ilex aquifolium, flos, Impatiens glandulifera, flos, Iodium, Moschus, Salix vitellina, flos, Tarentula hispana, Terebinthina, Veratrum album LIQUID ORAL 20130312 UNAPPROVED HOMEOPATHIC King Bio Inc. ATROPA BELLADONNA; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CICHORIUM INTYBUS FLOWER; CIMEX LECTULARIUS; FAGUS SYLVATICA FLOWERING TOP; GALLIC ACID MONOHYDRATE; GARLIC; ILEX AQUIFOLIUM FLOWERING TOP; IMPATIENS GLANDULIFERA FLOWER; IODINE; LYCOSA TARANTULA; LYTTA VESICATORIA; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; SALIX ALBA FLOWERING TOP; TURPENTINE OIL; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 57955-1020_354f8622-ccd2-4079-9c0f-b8321973b970 57955-1020 HUMAN OTC DRUG Easily Angered Aesculus carnea, flos, Aesculus hippocastanum, flos, Agrimonia eupatoria, flos, Antimonium crudum, Avena sativa, Chamomilla, Colocynthis, Crocus sativus, Ferrum metallicum, Impatiens glandulifera, flos, Kali carbonicum, Natrum muriaticum, Populus tremula, flos, Staphysagria, Thyroidinum LIQUID ORAL 20140113 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS CARNEA FLOWER; AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWER; ANTIMONY TRISULFIDE; AVENA SATIVA FLOWERING TOP; CITRULLUS COLOCYNTHIS FRUIT PULP; DELPHINIUM STAPHISAGRIA SEED; IMPATIENS GLANDULIFERA FLOWER; IRON; MATRICARIA RECUTITA; POPULUS TREMULA FLOWERING TOP; POTASSIUM CARBONATE; SAFFRON; SODIUM CHLORIDE; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1021_bbaa768f-c3a8-4770-a1a7-9102f236249b 57955-1021 HUMAN OTC DRUG Easily Angered Aesculus carnea, flos, Aesculus hippocastanum, flos, Agrimonia eupatoria, flos, Antimonium crudum, Avena sativa, Chamomilla, Colocynthis, Crocus sativus, Ferrum metallicum, Impatiens glandulifera, flos, Kali carbonicum, Natrum muriaticum, Populus tremula, flos, Staphysagria, Thyroidinum LIQUID ORAL 20140402 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS CARNEA FLOWER; AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWER; ANTIMONY TRISULFIDE; AVENA SATIVA FLOWERING TOP; CITRULLUS COLOCYNTHIS FRUIT PULP; DELPHINIUM STAPHISAGRIA SEED; IMPATIENS GLANDULIFERA FLOWER; IRON; MATRICARIA RECUTITA; POPULUS TREMULA FLOWERING TOP; POTASSIUM CARBONATE; SAFFRON; SODIUM CHLORIDE; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1041_4efe5c62-cb03-480c-aee1-48c6b61c57e1 57955-1041 HUMAN OTC DRUG Vindictive Absinthium, Aloe socotrina, Arnica montana, Colocynthis, Fagus sylvatica, flos, Hepar sulphuris calcareum, Ilex aquifolium, flos, Ipecacuanha, Malus pumila, flos, Nitricum acidum, Nux vomica, Pinus sylvestris, flos, Platinum metallicum, Salix vitellina, flos, Strychninum, Thea sinensis, Verbascum thapsus LIQUID ORAL 20131217 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; ARNICA MONTANA; CALCIUM SULFIDE; CITRULLUS COLOCYNTHIS FRUIT PULP; FAGUS SYLVATICA FLOWERING TOP; GREEN TEA LEAF; ILEX AQUIFOLIUM FLOWERING TOP; IPECAC; MALUS DOMESTICA FLOWER; NITRIC ACID; PINUS SYLVESTRIS FLOWERING TOP; PLATINUM; SALIX ALBA FLOWERING TOP; STRYCHNINE; STRYCHNOS NUX-VOMICA SEED; VERBASCUM THAPSUS; WORMWOOD 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1070_41ef5ea4-58b8-48ed-8c32-f48f19f5c063 57955-1070 HUMAN OTC DRUG Self Abuse Agaricus muscarius, Aloe socotrina, Aurum metallicum, Carboneum sulphuratum, Chamomilla, Cimicifuga racemosa, Ilex aquifolium, flos, Lilium tigrinum, Malus pumila, flos, Millefolium, Natrum carbonicum, Pinus sylvestris, flos, Stramonium, Tarentula hispana LIQUID ORAL 20130807 UNAPPROVED HOMEOPATHIC King Bio Inc. ACHILLEA MILLEFOLIUM; ALOE; AMANITA MUSCARIA FRUITING BODY; BLACK COHOSH; CARBON DISULFIDE; DATURA STRAMONIUM; GOLD; ILEX AQUIFOLIUM FLOWERING TOP; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOSA TARANTULA; MALUS DOMESTICA FLOWER; MATRICARIA RECUTITA; PINUS SYLVESTRIS FLOWERING TOP; SODIUM CARBONATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1257_2aebb1f7-8d9a-4c4c-a192-9c861b055acb 57955-1257 HUMAN OTC DRUG Expressed Sexual Issues Arnica montana, Avena sativa, Cantharis, Chamomilla, Helianthus annuus, Hyoscyamus niger, Malus pumila, flos, mimulus guttatus, flos, moschus, murex purpurea, ocimum basilicum, ornithogalum umbellatum, flos, Phytolacca decandra, Platinum metallicum, Salix nigra, Stramonium, Tarentula hispana LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; BASIL; DATURA STRAMONIUM; HELIANTHUS ANNUUS FLOWERING TOP; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; HYOSCYAMUS NIGER; LYCOSA TARANTULA; LYTTA VESICATORIA; MALUS DOMESTICA FLOWER; MATRICARIA RECUTITA; MIMULUS GUTTATUS FLOWERING TOP; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; PLATINUM; SALIX NIGRA BARK 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1260_2dd8b990-01be-40b1-8fff-f484fd17295a 57955-1260 HUMAN PRESCRIPTION DRUG Repressed Sexual Issues Agnus castus, Arundo mauritanica, Avena sativa, Conium maculatum, Gelsemium sempervirens, Ilex aquifolium, flos, Moschus, Origanum majorana, Pinus sylvestris, flos, Selenium metallicum, Sepia, Staphysagria LIQUID ORAL 20120312 UNAPPROVED HOMEOPATHIC King Bio Inc. ARUNDO PLINIANA ROOT; AVENA SATIVA FLOWERING TOP; CHASTE TREE; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; ILEX AQUIFOLIUM FLOWERING TOP; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; ORIGANUM MAJORANA WHOLE; PINUS SYLVESTRIS FLOWERING TOP; SELENIUM; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1270_991305ec-bd96-44e6-805f-4a0cec54ff21 57955-1270 HUMAN PRESCRIPTION DRUG Sexual Identity Ammonioum muriaticum, Conium maculatum, Ignatia amara, Juglans regia, flos, Mancinella, Natrum muriaticum, Ocimum basilicum, Phosphorus, Platinum metallicum, Sepia, Staphysagria, Thuja occidentalis LIQUID ORAL 20130312 UNAPPROVED HOMEOPATHIC King Bio Inc. AMMONIUM CHLORIDE; BASIL; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; JUGLANS REGIA FLOWERING TOP; PHOSPHORUS; PLATINUM; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 57955-1271_1be952e4-760b-4fc9-979f-2afef09fc106 57955-1271 HUMAN OTC DRUG Sexual Identity Ammonium muriaticum, Conium maculatum, Ignatia amara, Juglans regia, flos, Mancinella, Natrum muriaticum, Ocimum basilicum, Phosphorus, Platinum metallicum, Sepia, Staphysagria, Thuja occidentalis LIQUID ORAL 20131210 UNAPPROVED HOMEOPATHIC King Bio Inc. AMMONIUM CHLORIDE; BASIL; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; JUGLANS REGIA FLOWERING TOP; PHOSPHORUS; PLATINUM; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1500_cccd09ea-09cf-4d14-90ed-d8d1f1956313 57955-1500 HUMAN OTC DRUG Apathy Adrenalinum, Bromus ramosus, flos, Calcarea iodata, Capsicum annuum, Carduus marianus, Carpinus betulus, flos, Chelidonium majus, Chionanthus virginica, Cinchona officinalis, Cytisus Scoparius, Juglans regia, flos, Mentha piperita, Oxytropis lambertii, Parthenium, Phosphoricum acidum, Picricum acidum, Saponaria officinalis, Scleranthus annuus, flos, Zincum metallicum LIQUID ORAL 20130701 UNAPPROVED HOMEOPATHIC King Bio Inc. BROMUS RAMOSUS FLOWER; CALCIUM IODIDE; CAPSICUM; CARPINUS BETULUS FLOWERING TOP; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CYTISUS SCOPARIUS FLOWERING TOP; EPINEPHRINE; JUGLANS REGIA FLOWERING TOP; MENTHA PIPERITA; OXYTROPIS LAMBERTII TOP; PARTHENIUM HYSTEROPHORUS; PHOSPHORIC ACID; PICRIC ACID; SAPONARIA OFFICINALIS ROOT; SCLERANTHUS ANNUUS FLOWERING TOP; SILYBUM MARIANUM SEED; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1520_a352e56f-7846-434e-b7db-fdc101274d15 57955-1520 HUMAN PRESCRIPTION DRUG Sluggish Mind Adrenalinum, Agnus Castus, Ailanthus glandulosus, Aletris farinosa, Anethum graveolens, Bromus ramosus, flos, Caladium seguinum, Carpinus betulus, flos, Clematis vitalba, flos, Clematis vitalba, flos, Conium maculatum, Helleborus niger, Conium maculatum, Helleborus niger, Hypericum perforatum, Lecithin, Mentha piperita, Natrum carbonicum, Olea europaea, flos, Oleander, Phosphoricum acidum, Plumbum metallicum, Tropaeolum majus, Xerophyllum asphodeloides, Zincum metallicum LIQUID ORAL 20130226 UNAPPROVED HOMEOPATHIC King Bio Inc. AILANTHUS ALTISSIMA FLOWERING TWIG; ALETRIS FARINOSA ROOT; BROMUS RAMOSUS FLOWER; CARPINUS BETULUS FLOWERING TOP; CHASTE TREE; CLEMATIS VITALBA FLOWER; CONIUM MACULATUM FLOWERING TOP; DIEFFENBACHIA SEGUINE; DILL; EGG PHOSPHOLIPIDS; EPINEPHRINE; HELLEBORUS NIGER ROOT; HYPERICUM PERFORATUM; LEAD; MENTHA PIPERITA; NERIUM OLEANDER LEAF; OLEA EUROPAEA FLOWER; PHOSPHORIC ACID; SODIUM CARBONATE; TROPAEOLUM MAJUS; XEROPHYLLUM ASPHODELOIDES; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 57955-1530_bdf86f94-8de0-4c73-b13e-48d69b4c48d4 57955-1530 HUMAN PRESCRIPTION DRUG Restless Mind Aconitum ferox, Adrenalinum, Aesculus hippocastanum, flos, Apis mellifica, Argentum nitricum, Avena sativa, Baptisia tinctoria, Mentha piperita, Myosotis arvensis, Phosphorus, Ranunculus bulbosus, Scleranthus annuus, flos, Scutellaria lateriflora, Sumbul, Thyroidinum, Verbena officinalis, flos, Viola odorata LIQUID ORAL 20130228 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM FEROX ROOT; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; EPINEPHRINE; FERULA SUMBUL ROOT; MENTHA PIPERITA; MYOSOTIS ARVENSIS; PHOSPHORUS; RANUNCULUS BULBOSUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA; SILVER NITRATE; THYROID, UNSPECIFIED; VERBENA OFFICINALIS FLOWERING TOP; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 57955-1531_ae71aa91-09fc-4aa9-b335-08c4b9d58c92 57955-1531 HUMAN OTC DRUG Restless Mind Aconitum ferox, Adrenalinum, Aesculus hippocastanum, flos, Apis mellifica, Argentum nitricum, Avena sativa, Baptisia tinctor, Mentha piperita, Myosotis arvensis, Phosphorus, Ranunculus bulbosus, Scleranthus annuus, flos, Scutellaria lateriflora, Sumbul, Thyroidinum, Verbena officinalis, flos, Viola odorata LIQUID ORAL 20131219 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM FEROX ROOT; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; EPINEPHRINE; FERULA SUMBUL ROOT; MENTHA PIPERITA; MYOSOTIS ARVENSIS; PHOSPHORUS; RANUNCULUS BULBOSUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA; SILVER NITRATE; THYROID, UNSPECIFIED; VERBENA OFFICINALIS FLOWERING TOP; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1541_3f63e59f-87ba-48ff-8cd0-883db9f1afcf 57955-1541 HUMAN OTC DRUG Spaced out Asarum europaeum, Clematis erecta, Clematis vitalba, flos, cocculus indicus, Lathyrus sativus, Lonicera caprifolium, flos, Millefolium, Naja tripudians, Nux moschata, Oleander, Rosa damascena, Rosmarinus officinalis, Stigmata maidis, Sulphur LIQUID ORAL 20140407 UNAPPROVED HOMEOPATHIC King Bio Inc. ACHILLEA MILLEFOLIUM; ANAMIRTA COCCULUS SEED; ASARUM EUROPAEUM; CLEMATIS RECTA FLOWERING TOP; CLEMATIS VITALBA FLOWER; CORN SILK; LATHYRUS SATIVAS SEED; LONICERA CAPRIFOLIUM FLOWERING TOP; NAJA NAJA VENOM; NERIUM OLEANDER LEAF; NUTMEG; ROSA DAMASCENA FLOWERING TOP; ROSMARINUS OFFICINALIS FLOWERING TOP; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1561_b5e10703-f6cb-45a0-9935-07864dd087d5 57955-1561 HUMAN OTC DRUG Mental Alertness For Seniors Agnus castus, Aletris farinosa, Alumina, Avena sativa, Carpinus betulus, flos, Clematis vitalba, flos, Conium maculatum, Lecithin, Mentha piperita, Nux moschata, Olea europaea, flos, Picricum acidum, Plumbum metallicum, Zincum metallicum LIQUID ORAL 20140602 UNAPPROVED HOMEOPATHIC King Bio Inc. ALETRIS FARINOSA ROOT; ALUMINUM OXIDE; AVENA SATIVA FLOWERING TOP; CARPINUS BETULUS FLOWERING TOP; CHASTE TREE; CLEMATIS VITALBA FLOWER; CONIUM MACULATUM FLOWERING TOP; EGG PHOSPHOLIPIDS; LEAD; MENTHA PIPERITA; NUTMEG; OLEA EUROPAEA FLOWER; PICRIC ACID; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1700_5eb1b9b5-da59-4d81-9b9e-5e474f80f783 57955-1700 HUMAN OTC DRUG Allergies Formula Allium cepa, Ambrosia artemisiaefolia, Dulcamara, Euphrasia officinalis, Histaminum hydrochloricum, Kali muriaticum, Naphthalinum, Natrum muriaticum LIQUID ORAL 20140120 UNAPPROVED HOMEOPATHIC King Bio Inc. AMBROSIA ARTEMISIIFOLIA; EUPHRASIA STRICTA; HISTAMINE DIHYDROCHLORIDE; NAPHTHALENE; ONION; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1751_5939f149-7f2b-48bb-9290-388ea569e234 57955-1751 HUMAN OTC DRUG Intense Anxiety Aconitum napellus, Aethusa cynapium, Argentum nitricum, Arsenicum album, Borago officinalis, Bryonia, Castanea sativa, flos, Cytisus scoparius, Digitalis purpurea, Eriodictyon californicum, Jatropha curcas, Laurocerasus, Lolium temulentum, Mancinella, Murex purpurea, Rhus toxicodendron, Sinapis arvensis, flos, Spongia tosta LIQUID ORAL 20140113 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; AETHUSA CYNAPIUM; ARSENIC TRIOXIDE; BORAGE; BRYONIA ALBA ROOT; CASTANEA SATIVA FLOWER; CYTISUS SCOPARIUS FLOWERING TOP; DIGITALIS; ERIODICTYON CALIFORNICUM LEAF; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; JATROPHA CURCAS SEED; LOLIUM TEMULENTUM TOP; PRUNUS LAUROCERASUS LEAF; SILVER NITRATE; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; SPONGIA OFFICINALIS SKELETON, ROASTED; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1770_396da866-fd61-4f45-9491-ad033bbeb03e 57955-1770 HUMAN OTC DRUG First Aid for Mind and Body Aconitum napellus, Apis mellifica, Arnica montana, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Cistus canadensis, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Impatiens glandulifera, flos, ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, sulphur, Symphytum officinale, Trifolium pratense, Veratrum album LIQUID ORAL 20140401 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS VITALBA FLOWER; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; SULFUR; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1791_19e1dd0e-44ea-4294-b7cb-240c7edd2e54 57955-1791 HUMAN OTC DRUG Fear and Phobia Abelmoschus, Aconitum napellus, Allium sativum, Arsenicum album, Calcarea carbonica, Chamomilla, Cocculus indicus, Erodium, Gelsemium sempervirens, Hypericum perforatum, Kali arsenicosum, Lilium tigrinum, Mimulus guttatus, flos, Phosphorus, Populus tremula, flos, Pulsatilla, Stramonium, Symphytum officinale, Ulmus procera, flos LIQUID ORAL 20131210 UNAPPROVED HOMEOPATHIC King Bio Inc. ABELMOSCHUS MOSCHATUS SEED; ACONITUM NAPELLUS; ANAMIRTA COCCULUS SEED; ARSENIC TRIOXIDE; COMFREY ROOT; DATURA STRAMONIUM; ERODIUM CICUTARIUM; GARLIC; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; LILIUM LANCIFOLIUM WHOLE FLOWERING; MATRICARIA RECUTITA; MIMULUS GUTTATUS FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POPULUS TREMULA FLOWERING TOP; POTASSIUM ARSENITE ANHYDROUS; PULSATILLA VULGARIS; ULMUS PROCERA FLOWERING TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1800_64fc245d-e7e1-4c0a-ae08-909dd402024d 57955-1800 HUMAN OTC DRUG Hypochondria Aconitum napellus, Allium sativum, Antimonium tartaricum, Arnica montana, Asafoetida, Cactus grandiflorus, Chamomilla, Erodium, Gratiola officinalis, Hypericum perforatum, Mezereum, Mimulus guttatus, flos, Petroleum, Phosphorus, Populus tremula, flos, Stannum metallicum, Staphysagria, Symphytum officinale, Ulmus procera, flos LIQUID ORAL 20130808 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ASAFETIDA; COMFREY ROOT; DAPHNE MEZEREUM BARK; DELPHINIUM STAPHISAGRIA SEED; ERODIUM CICUTARIUM; GARLIC; GRATIOLA OFFICINALIS; HYPERICUM PERFORATUM; KEROSENE; MATRICARIA RECUTITA; MIMULUS GUTTATUS FLOWERING TOP; PHOSPHORUS; POPULUS TREMULA FLOWERING TOP; SELENICEREUS GRANDIFLORUS STEM; TIN; ULMUS PROCERA FLOWERING TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1801_85e137c5-00cb-40d5-96e6-7a90661bede4 57955-1801 HUMAN OTC DRUG Multi-Strain Flu Relief Anas barbariae, hepatis et cordis extractum, Arsenicum album, Baptisia tinctoria, Bryonia, Causticum, Cinchona officinalis, Echinacea purpurea, Eucalyptus globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Influenzinum, Phytolacca decandra, Rhus toxicodendron, Sarcolacticum acidum, Sulphur, Wyethia helenioides, Zincum aceticum, Zincum muriaticum, Zincum oxydatum LIQUID ORAL 20140822 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; CAUSTICUM; CINCHONA OFFICINALIS BARK; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LACTIC ACID, L-; PHYTOLACCA AMERICANA ROOT; SULFUR; TOXICODENDRON PUBESCENS LEAF; WYETHIA HELENIOIDES ROOT; ZINC ACETATE ANHYDROUS; ZINC CHLORIDE; ZINC OXIDE 10; 10; 10; 35; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1803_2d6a56c6-3d77-478d-a83e-cad3b91adfdd 57955-1803 HUMAN OTC DRUG BronchialCare Soins Des Bronches Aconitum napellus, Adrenalinum, Ammonium carbonicum, Antimonium tartaricum, Aralia racemosa, Bromium, Chlorinum, Eriodictyon californicum, Eucalyptus globulus, Grindelia, Lobelia inflata, Natrum sulphuricum, Phosphorus, Quebracho, Trifolium pratense LIQUID ORAL 20140806 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; AMMONIUM CARBONATE; ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; BROMINE; CHLORINE; EPINEPHRINE; ERIODICTYON CALIFORNICUM LEAF; EUCALYPTUS GLOBULUS LEAF; GRINDELIA HIRSUTULA FLOWERING TOP; LOBELIA INFLATA; PHOSPHORUS; SODIUM SULFATE; TRIFOLIUM PRATENSE FLOWER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1804_ef0ac0d3-b319-4ff8-94d3-825ebdf99a8c 57955-1804 HUMAN OTC DRUG Arthritis Pain and Joint Relief / Soulagement De La Douleur Arthritique Et Articulaire Actaea spicata, Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Causticum, Cimicifuga racemosa, Formicum acidum, Hypericum perforatum, Ledum palustre, Lithium carbonicum, Magnesia phosphorica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhododendron chrysanthum, Rhus toxicodendron, Ruta graveolens, Salicylicum acidum, Sepia, Zincum metallicum LIQUID ORAL 20140806 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTAEA SPICATA ROOT; ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAUSTICUM; FORMIC ACID; HORSE CHESTNUT; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1805_ad734932-5b15-4e10-98cd-bb002a849e8d 57955-1805 HUMAN OTC DRUG Stress Control / Controle Du Stress Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Clematis erecta, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Passiflora incarnata, Phosphorus, Rhus toxicodendron, Sulphur, Symphytum officinale, Veratrum album LIQUID ORAL 20140805 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS RECTA FLOWERING TOP; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; STRYCHNOS IGNATII SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1806_06115262-049f-4b87-899f-5868701b7b72 57955-1806 HUMAN OTC DRUG Respiratory Care / Congestion Pulmonaire Et Bronchique Ammonium carbonicum, Antimonium tartaricum, Carbo vegetabilis, Chlorinum, Kali carbonicum, Lobelia inflata, Phosphorus, silicea, Stannum metallicum LIQUID ORAL 20140825 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; AMMONIUM CARBONATE; ANTIMONY POTASSIUM TARTRATE; CHLORINE; LOBELIA INFLATA; PHOSPHORUS; POTASSIUM CARBONATE; SILICON DIOXIDE; TIN 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1810_94fb6aaa-a0b6-463f-bea0-b2f488a6d468 57955-1810 HUMAN OTC DRUG Fears and Nightmares Aconitum napellus, Aesculus carnea, flos, Allium sativum, Aurum bromatum, Calcarea carbonica, Chamomilla, Cina, Helianthemum nummularium, flos, Ignatia amara, Kali bromatum, Lycopodium clavatum, Mimulus guttatus, flos, Paeonia officinalis, Phosphorus, Populus tremula, flos, Phus toxicodendron, Stramonium, Sulphur, Viola odorata LIQUID ORAL 20130808 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; AESCULUS CARNEA FLOWER; ARTEMISIA CINA PRE-FLOWERING TOP; DATURA STRAMONIUM; GARLIC; GOLD TRIBROMIDE; HELIANTHEMUM NUMMULARIUM FLOWER; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; MIMULUS GUTTATUS FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PAEONIA OFFICINALIS ROOT; PHOSPHORUS; POPULUS TREMULA FLOWERING TOP; POTASSIUM BROMIDE; STRYCHNOS IGNATII SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1821_fa5125aa-3e96-477f-a6da-510dab2ed5d8 57955-1821 HUMAN OTC DRUG Claustrophobia Aconitum napellus, Angelica archangelica, Argentum nitricum, Arnica montana, Calendula officinalis, Cimicifuga racemosa, Cistus canadensis, Clematis vitalba, flos, Hypericum perforatum, Impatiens glandulifera, flos, Nitricum acidum, Ornithogalum umbellatum, Prunus cerasifera, flos, Pulsatilla LIQUID ORAL 20131210 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ANGELICA ARCHANGELICA ROOT; ARNICA MONTANA; BLACK COHOSH; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS VITALBA FLOWER; HELIANTHEMUM CANADENSE; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; NITRIC ACID; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER; PULSATILLA VULGARIS; SILVER NITRATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1830_e8dbefd8-6d4e-4e5e-9c52-dda756bd070d 57955-1830 HUMAN PRESCRIPTION DRUG Obsessions/Compulsions Arsenicum album, Arsenicum iodatum, Calcarea carbonica, Coffea cruda, Cytisus scoparius, Iodium, Mancinella, Mentha poperita, Physostigma venenosum, Silicea, Ulmus procera, flos, Verbascum thapsus LIQUID ORAL 20130225 UNAPPROVED HOMEOPATHIC King Bio Inc. ARABICA COFFEE BEAN; ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; CYTISUS SCOPARIUS FLOWERING TOP; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; IODINE; MENTHA PIPERITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYSOSTIGMA VENENOSUM SEED; SILICON DIOXIDE; ULMUS PROCERA FLOWERING TWIG; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 57955-1831_d405c8e4-9e75-461a-a603-552e3fa9cb62 57955-1831 HUMAN OTC DRUG Obsessions/Compulsions Arsenicum album, Arsenicum iodatum, Calcarea carbonica, Coffea cruda, Cytisus scoparius, Iodium, Mancinella, Mentha piperita, Physostigma venenosum, Silicea, Ulmus procera, flos, Verbascum thapsus LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ARABICA COFFEE BEAN; ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; CYTISUS SCOPARIUS FLOWERING TOP; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; IODINE; MENTHA PIPERITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYSOSTIGMA VENENOSUM SEED; SILICON DIOXIDE; ULMUS PROCERA FLOWERING TWIG; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1840_7229d38d-89a5-42a7-bcb5-b58411a5874d 57955-1840 HUMAN OTC DRUG Perfectionism Aceticum acidum, Borago officinalis, Cereus bonplandii, Cyclamen europaeum, Ignatia amara, Passiflora incarnata, Silicea, Sinapis arvensis, flos, Spiraea ulmaria, Staphysagria, Strontium carbonicum, Tropaeolum majus LIQUID ORAL 20130701 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETIC ACID; BORAGE; CYCLAMEN PURPURASCENS TUBER; DELPHINIUM STAPHISAGRIA SEED; FILIPENDULA ULMARIA ROOT; HARRISIA POMANENSIS STEM; PASSIFLORA INCARNATA FLOWERING TOP; SILICON DIOXIDE; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; STRONTIUM CARBONATE; STRYCHNOS IGNATII SEED; TROPAEOLUM MAJUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1850_85b00476-479d-4ac5-be53-a889d7063301 57955-1850 HUMAN PRESCRIPTION DRUG Stress Control Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Clematis erecta, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Impatiens glandulifera, flos, Ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, sulphur, Symphytum officinale, Veratrum album LIQUID ORAL 20130415 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS RECTA FLOWERING TOP; CLEMATIS VITALBA FLOWER; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; STRYCHNOS IGNATII SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] 57955-1851_2634b232-2f55-42b6-acd4-252250a6a8f8 57955-1851 HUMAN OTC DRUG Stress Control Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Clematis erecta, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Impatiens glandulifera, flos, Ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, Sulphur, Symphytum officinale, Veratrum album LIQUID ORAL 20131217 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS RECTA FLOWERING TOP; CLEMATIS VITALBA FLOWER; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; STRYCHNOS IGNATII SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1903_65ec3e08-bc72-4545-81ec-9185cdf3dc3a 57955-1903 HUMAN OTC DRUG Better Breath Arnica montana, Arsenicum album, Aurum metallicum, Baptisia tinctoria, Calcarea carbonica, Calcarea fluorica, Carbo vegetabilis, Carbolicum acidum, Gambogia, Hekla lava, Iodium, Kali phosphoricum, Kreosotum, Mercurius corrosivus, Mercurius vivus, Nitricum acidum, Petroleum, Quercus robur, Staphysagria, Sulphur LIQUID ORAL 20140505 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CALCIUM FLUORIDE; DELPHINIUM STAPHISAGRIA SEED; GAMBOGE; GOLD; HEKLA LAVA; IODINE; KEROSENE; MERCURIC CHLORIDE; MERCURY; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHENOL; POTASSIUM PHOSPHATE, DIBASIC; QUERCUS ROBUR TWIG BARK; SULFUR; WOOD CREOSOTE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-1904_f82a5db9-c2ef-4a19-9d69-8a1bdc4f467d 57955-1904 HUMAN OTC DRUG Dental Plak Baptisia tinctoria, Calcarea carbonica, Carbo vegetabilis, Kreosotum, Magnesia phosphorica, Mercurius vivus, Phosphorus, Sulphur LIQUID ORAL 20140505 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; BAPTISIA TINCTORIA ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURY; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SULFUR; WOOD CREOSOTE 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; 1/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2010_2c24549c-b54b-44e4-b9e3-ee04910654d8 57955-2010 HUMAN OTC DRUG Melancholic Alfalfa, Ammonium carbonicum, Anethum graveolens, Antimonium crudum, Aurum metallicum, Benzoicum acidum, Berberis aquifolium, Fagus sylvatica, flos, Ilex aquifolium, flos, Lycopodium clavatum, Millefolium, Muriaticum acidum, Psorinum, Salix vitellina, flos LIQUID ORAL 20130820 UNAPPROVED HOMEOPATHIC King Bio Inc. ACHILLEA MILLEFOLIUM; ALFALFA; AMMONIUM CARBONATE; ANTIMONY TRISULFIDE; BENZOIC ACID; DILL; FAGUS SYLVATICA FLOWERING TOP; GOLD; HYDROCHLORIC ACID; ILEX AQUIFOLIUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; MAHONIA AQUIFOLIUM ROOT BARK; SALIX ALBA FLOWERING TOP; SCABIES LESION LYSATE (HUMAN) 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2030_7715ac5b-1e4c-4ed1-a192-521a165dbead 57955-2030 HUMAN OTC DRUG Heart Ache Aloe socotrina, Ambra grisea, Ammonium muriaticum, Antimonium crudum, Aurum metallicum, Borago officinalis, Cichorium intybus, flos, Cimicifuga racemosa, Eriodictyon californicum, Ignatia amara, Ilex aquifolium, flos, Iodium, Natrum muriaticum, Phosphoricum acidum, Rosa damascena, Stannum metallicum, Tilia europaea LIQUID ORAL 20130812 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; AMBERGRIS; AMMONIUM CHLORIDE; ANTIMONY TRISULFIDE; BLACK COHOSH; BORAGE; CICHORIUM INTYBUS FLOWER; ERIODICTYON CALIFORNICUM LEAF; GOLD; ILEX AQUIFOLIUM FLOWERING TOP; IODINE; PHOSPHORIC ACID; ROSA DAMASCENA FLOWERING TOP; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; TILIA X EUROPAEA FLOWER; TIN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2040_d51fa8b4-2d8c-477c-9b1e-3e8db5f483d0 57955-2040 HUMAN PRESCRIPTION DRUG Chagrined Allium sativum, Argentum nitricum, Asafoetida, Calendula officinalis, Capsicum annuum, Ceanothus americanus, Colocynthis, Ignatia amara, Lachesis mutus, Lobelia cardinalis, Nux vomica, Pinus sylvestris, flos, Solidago virgaurea, Taraxacum officinale LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC King Bio Inc. ASAFETIDA; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; CEANOTHUS AMERICANUS LEAF; CITRULLUS COLOCYNTHIS FRUIT PULP; GARLIC; LACHESIS MUTA VENOM; LOBELIA CARDINALIS; PINUS SYLVESTRIS FLOWERING TOP; SILVER NITRATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 57955-2050_bb652043-d781-4c98-b8d9-3b231864009c 57955-2050 HUMAN PRESCRIPTION DRUG Guilt Agrimonia eupatoria, flos, Arsenicum album, Ceratostigma willmottianum, flos, cuprum metallicum, Cyclamen europaeum, Digitalis purpurea, Ignatia amara, Juglans regia, flos, Millefolium, Natrum muriaticum, Phosphoricum acidum, Pinus sylvestris, flos, Thuja occidentalis, Verbascum thapsus LIQUID ORAL 20130516 UNAPPROVED HOMEOPATHIC King Bio Inc. ACHILLEA MILLEFOLIUM; AGRIMONIA EUPATORIA FLOWER; ARSENIC TRIOXIDE; CERATOSTIGMA WILLMOTTIANUM FLOWER; COPPER; CYCLAMEN PURPURASCENS TUBER; DIGITALIS; JUGLANS REGIA FLOWERING TOP; PHOSPHORIC ACID; PINUS SYLVESTRIS FLOWERING TOP; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THUJA OCCIDENTALIS LEAFY TWIG; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 57955-2061_3c1ab9dd-ac96-4f2f-a266-55eb4caf3d04 57955-2061 HUMAN OTC DRUG Grief Ammonium muriaticum, Apis mellifica, Aurum metallicum, Borago officinalis, Causticum, Eriodictyon californicum, Gelsemium sempervirens, Ignatia amara, Natrum muriaticum, Ornithogalum umbellatum, flos, Phosphoricum acidum, Pinus sylvestris, flos, Rosa damascena, Taraxacum officinale LIQUID ORAL 20140718 UNAPPROVED HOMEOPATHIC King Bio Inc. AMMONIUM CHLORIDE; APIS MELLIFERA; BORAGE; CAUSTICUM; ERIODICTYON CALIFORNICUM LEAF; GELSEMIUM SEMPERVIRENS ROOT; GOLD; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PHOSPHORIC ACID; PINUS SYLVESTRIS FLOWERING TOP; ROSA DAMASCENA FLOWERING TOP; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2071_242cc927-0d1e-42db-8b3f-c9c64fe3d8bf 57955-2071 HUMAN OTC DRUG Overly Sensitive Aloe socotrina, Anacardium orientale, Asterias rubens, Aurum metallicum, Carpinus betulus, flos, Chamomilla, Cinchona officinalis, Eriodictyon californicum, Ignatia amara, Lycopodium clavatum, Mentha piperita, Millefolium, Nasturtium aquaticum, Natrum carbonicum, Natrum muriaticum, Palladium metallicum, Petroleum, Ranunculus bulbasus, Sarsaparilla, Sepia, Taraxacum officinale LIQUID ORAL 20131023 UNAPPROVED HOMEOPATHIC King Bio Inc. ACHILLEA MILLEFOLIUM; ALOE; ASTERIAS RUBENS; CARPINUS BETULUS FLOWERING TOP; CINCHONA OFFICINALIS BARK; ERIODICTYON CALIFORNICUM LEAF; GOLD; KEROSENE; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; MENTHA PIPERITA; NASTURTIUM OFFICINALE; PALLADIUM; RANUNCULUS BULBOSUS; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SMILAX REGELII ROOT; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2181_13cb51a8-2237-4a24-89e5-1336a5d2a0be 57955-2181 HUMAN PRESCRIPTION DRUG Appetite and Weight with P.H.A.T. Adrenalinum, Adrenocorticotrophin, Agrimonia eupatoria, flos, Anacardium orientale, Antimonium crudum, Calcarea carbonica, Castanea sativa, flos, Cortisone aceticum, Fucus vesiculosus, Hypothalamus, Kali bichromicum, Oleander, Pituitarum posterium, Sabadilla, Staphysagria, Thyroidinum LIQUID ORAL 20121212 UNAPPROVED HOMEOPATHIC King Bio Inc. AGRIMONIA EUPATORIA FLOWER; ANTIMONY TRISULFIDE; BOS TAURUS HYPOTHALAMUS; CASTANEA SATIVA FLOWER; CORTICOTROPIN; CORTISONE ACETATE; DELPHINIUM STAPHISAGRIA SEED; EPINEPHRINE; FUCUS VESICULOSUS; NERIUM OLEANDER LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; SCHOENOCAULON OFFICINALE SEED; SEMECARPUS ANACARDIUM JUICE; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 57955-2205_1a9809e8-fd60-42b3-95a0-acc28f34a5c8 57955-2205 HUMAN OTC DRUG Allergies Fragrances and Phenolics Acetaldehyde, Arsenicum album, Balsamum peruvianum, Calcarea carbonica, Carbolicum acidum, Conium maculatum, Coumarinum, Crocus sativus, Histaminum hydrochloricum, Lachesis mutus, Lycopodium clavatum, Phosphorus, Sepia LIQUID ORAL 20140324 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETALDEHYDE; ARSENIC TRIOXIDE; BALSAM PERU; CONIUM MACULATUM FLOWERING TOP; COUMARIN; HISTAMINE DIHYDROCHLORIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHENOL; PHOSPHORUS; SAFFRON; SEPIA OFFICINALIS JUICE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2251_419e85d3-42d7-4a32-9989-18765e771cc5 57955-2251 HUMAN OTC DRUG Gossipy Agaricus muscarius, Clematis vitalba, flos, Lachesis mutus, Lathyrus sativus, Lonicera caprifolium, flos, Millefolium, Myristica sebifera, Paris quadrifolia, Pastinaca sativa, Podophyllinum, Pyrogenium, Rosa damascena, Sticta pulmonaria, Stigmata maidis, Stramonium, Veratrum album LIQUID ORAL 20140331 UNAPPROVED HOMEOPATHIC King Bio Inc. ACHILLEA MILLEFOLIUM; AMANITA MUSCARIA FRUITING BODY; CLEMATIS VITALBA FLOWER; CORN SILK; DATURA STRAMONIUM; LACHESIS MUTA VENOM; LATHYRUS SATIVAS SEED; LOBARIA PULMONARIA; LONICERA CAPRIFOLIUM FLOWERING TOP; PARIS QUADRIFOLIA; PARSNIP; PODOPHYLLUM RESIN; RANCID BEEF; ROSA DAMASCENA FLOWERING TOP; VERATRUM ALBUM ROOT; VIROLA SEBIFERA RESIN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2271_8a59b491-cb9e-4418-b7a2-4f0f1166c55f 57955-2271 HUMAN OTC DRUG Deceitful Argentum metallicum, Angelica archangelica, Asafoetida, Berberis aquifolium, Bismuthum oxydatum, Causticum, Ceanothus americanus, Ceratostigma willmottianum, flos, Cuprum metallicum, Drosera, Hypericum perforatum, Ignatia amara, Ilex aquifolium, flos, Lachesis mutus, Lycopodium clavatum, Nux moschata, Thuja occidentalis, Veratrum album, Verbascum thapsus LIQUID ORAL 20140331 UNAPPROVED HOMEOPATHIC King Bio Inc. ANGELICA ARCHANGELICA ROOT; ASAFETIDA; BISMUTH OXIDE; CAUSTICUM; CEANOTHUS AMERICANUS LEAF; CERATOSTIGMA WILLMOTTIANUM FLOWER; COPPER; DROSERA ROTUNDIFOLIA; HYPERICUM PERFORATUM; ILEX AQUIFOLIUM FLOWERING TOP; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAHONIA AQUIFOLIUM ROOT BARK; NUTMEG; SILVER; STRYCHNOS IGNATII SEED; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2281_cfc817d7-50a4-47e9-8333-f79ac862748d 57955-2281 HUMAN OTC DRUG Candida Heavy Metal Detox Aquaflora LIQUID ORAL 20110906 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; CADMIUM SULFIDE; CALOMEL; CHELIDONIUM MAJUS; CHROMIC OXIDE; COD LIVER OIL; COPPER; CYSTEINE; DAPHNE MEZEREUM BARK; GLYCERIN; GLYCYRRHIZA GLABRA; LEAD; LEAD IODIDE; MAGNESIUM SULFATE HEPTAHYDRATE; MERCURIC CHLORIDE; MERCURIC CYANIDE; NICKEL; PHYTOLACCA AMERICANA ROOT; POTASSIUM CHLORIDE; SELENIUM; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; TIN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2282_ea20a8a9-d3b9-4f98-bfb2-0391b254d8be 57955-2282 HUMAN OTC DRUG Reserved Aesculus carnea, flos, Aloe socotrina, Euphorbium officinarum, Fagus sylvatica, flos, Gelsemium sempervirens, Hypericum perforatum, Juglans regia, flos, Kali muriaticum, Magnesia muriatica, Millefolium, Muriaticum acidum, Natrum carbonicum, Phosphoricum acidum, Plumbum metallicum, Sepia, Spongia tosta, Stannum metallicum, Theridion LIQUID ORAL 20140623 UNAPPROVED HOMEOPATHIC King Bio Inc. ACHILLEA MILLEFOLIUM; AESCULUS CARNEA FLOWER; ALOE; EUPHORBIA RESINIFERA RESIN; FAGUS SYLVATICA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HYDROCHLORIC ACID; HYPERICUM PERFORATUM; JUGLANS REGIA FLOWERING TOP; LEAD; MAGNESIUM CHLORIDE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SEPIA OFFICINALIS JUICE; SODIUM CARBONATE; SPONGIA OFFICINALIS SKELETON, ROASTED; THERIDION CURASSAVICUM; TIN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2291_4898bdd4-f51d-4c9b-818b-68cc12f44c8f 57955-2291 HUMAN OTC DRUG Immature Agaricus muscarius, Allium sativum, Anethum graveolens, Antimonium crudum, Baryta carbonica, Berberis aquifolium, Bufo rana, Carboneum sulphuratum, Cicuta virosa, Eriodictyon californicum, Erodium, Impatiens glandulifera, flos, Lachesis mutus, Lobelia cardinalis, Lycopodium clavatum, Mimulus guttatus, flos, Moschus, Natrum carbonicum, Solidago virgaurea, Sulphur, Thyroidinum, Rhus toxicodendron, Viola odorata LIQUID ORAL 20131022 UNAPPROVED HOMEOPATHIC King Bio Inc. AMANITA MUSCARIA FRUITING BODY; ANTIMONY TRISULFIDE; BARIUM CARBONATE; BUFO BUFO CUTANEOUS GLAND; CARBON DISULFIDE; CICUTA VIROSA ROOT; DILL; ERIODICTYON CALIFORNICUM LEAF; ERODIUM CICUTARIUM; GARLIC; IMPATIENS GLANDULIFERA FLOWER; LACHESIS MUTA VENOM; LOBELIA CARDINALIS; LYCOPODIUM CLAVATUM SPORE; MAHONIA AQUIFOLIUM ROOT BARK; MIMULUS GUTTATUS FLOWERING TOP; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; SODIUM CARBONATE; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2300_5ce7e375-ef78-4660-bb5b-31dd3211a131 57955-2300 HUMAN OTC DRUG Complaining Anethum graveolens, Arnica montana, Asafoetida, Berberis aquifolium, Bismuthum metallicum, Calcarea phosphorica, Fagus sylvatica, flos, Ilex aquifolium, Lachesis mutus, Salix vitellina, flos, Sulphur, Zincum metallicum LIQUID ORAL 20130827 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; ASAFETIDA; BISMUTH; DILL; FAGUS SYLVATICA FLOWERING TOP; ILEX AQUIFOLIUM FLOWERING TOP; LACHESIS MUTA VENOM; MAHONIA AQUIFOLIUM ROOT BARK; SALIX ALBA FLOWERING TOP; SULFUR; TRIBASIC CALCIUM PHOSPHATE; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2311_f9003219-824d-41c5-b561-b66fccd49a5f 57955-2311 HUMAN OTC DRUG Calloused Allium sativum, Anacardium orientale, Calendula officinalis, Capsicum annuum, Ceanothus americanus, Chamomilla, Chelidonium majus, Conium maculatum, Kali carbonicum, Lobelia cardinalis, Mancinella, Myristica sebifera, Pinus sylvestris, flos, Stigmata maidis, Sepia, Taraxacum officinale, Thea sinensis LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; CORN SILK; GARLIC; GREEN TEA LEAF; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; LOBELIA CARDINALIS; MATRICARIA RECUTITA; PINUS SYLVESTRIS FLOWERING TOP; POTASSIUM CARBONATE; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE; VIROLA SEBIFERA RESIN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2322_2c12444d-b982-4387-b8c0-9c27fade5edf 57955-2322 HUMAN OTC DRUG Prejudiced Ferrum metallicum, Gratiola officinalis, Hamamelis virginiana, Helianthus annuus, Hottonia palustris, flos, Lachesis mutus, Lilium tigrinum, Lycopodium clavatum, Moschus, Palladium metallicum, Platinum metallicum, Rhus toxicodendron, Staphysagria, Sulphur, Veratrum album, Viola odorata LIQUID ORAL 20131212 UNAPPROVED HOMEOPATHIC King Bio Inc. DELPHINIUM STAPHISAGRIA SEED; GRATIOLA OFFICINALIS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HELIANTHUS ANNUUS FLOWERING TOP; HOTTONIA PALUSTRIS FLOWER; IRON; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; PALLADIUM; PLATINUM; SULFUR; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2331_2a4a7d86-85b4-4067-83f6-a044ae803ed1 57955-2331 HUMAN OTC DRUG Extravagant Agrimonia eupatoria, flos, Belladonna, Ceratostigma willmottianum, flos, Cinchona officinalis, Conium maculatum, Curare, Juglans regia, flos, Lachesis mutus, Lilium tigrinum, Palladium metallicum, Pinus sylvestris, flos, Rheum, Salvia officinalis, Verbascum thapsus LIQUID ORAL 20140422 UNAPPROVED HOMEOPATHIC King Bio Inc. AGRIMONIA EUPATORIA FLOWER; ATROPA BELLADONNA; CERATOSTIGMA WILLMOTTIANUM FLOWER; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; JUGLANS REGIA FLOWERING TOP; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; PALLADIUM; PINUS SYLVESTRIS FLOWERING TOP; RHEUM OFFICINALE ROOT; SAGE; TUBOCURARINE CHLORIDE; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2405_071b7d90-6ed9-4967-9355-1a852fe1fa18 57955-2405 HUMAN OTC DRUG Aller-Detox Food Additives and Preservatives Formicum acidum, Gambogia, Natrum bicarbonicum, Natrum nitricum, Natrum Nitrosum, Natrum sulphuricum, Nux vomica, Phosphoricum acidum, Phytolacca decandra, Rosa canina, Saccharinum LIQUID ORAL 20130820 UNAPPROVED HOMEOPATHIC King Bio Inc. FORMIC ACID; GAMBOGE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; ROSA CANINA FRUIT; SACCHARIN; SODIUM BICARBONATE; SODIUM NITRATE; SODIUM NITRITE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2407_22bbcc97-7276-4936-ad48-9d78fc68e0b6 57955-2407 HUMAN OTC DRUG Aller-Detox Cosmetics and Household Adrenalinum, Anacardium orientale, Blatta orientalis, Formalinum, Fumaria officinalis, Glycerinum, Graphites, Magnesia muriatica, Natrum pyruvicum, Nitricum acidum, Phosphorus, Phytolacca decandra, Pituitarum posterium, Pulsatilla, Sulphur LIQUID ORAL 20131001 UNAPPROVED HOMEOPATHIC King Bio Inc. BLATTA ORIENTALIS; EPINEPHRINE; FORMALDEHYDE; FUMARIA OFFICINALIS FLOWERING TOP; GLYCERIN; GRAPHITE; MAGNESIUM CHLORIDE; NITRIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SODIUM PYRUVATE; SULFUR; SUS SCROFA PITUITARY GLAND 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2408_b696bb18-fd07-4e44-a0f3-e84121c23e0e 57955-2408 HUMAN OTC DRUG Aller-Detox Indoor Pollution Control Acetaldehyde, Ammonium causticum, Carboneum oxygenisatum, Chloroformum, Formalinum, Hydrastis canadensis, Glycyrrhiza glabra, Kali bichromicum, Lycopodium clavatum, Plumbum metallicum, Petroleum, Taraxacum officinale LIQUID ORAL 20140321 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETALDEHYDE; AMMONIA; CARBON MONOXIDE; CHLOROFORM; FORMALDEHYDE; GLYCYRRHIZA GLABRA; GOLDENSEAL; KEROSENE; LEAD; LYCOPODIUM CLAVATUM SPORE; POTASSIUM DICHROMATE; TARAXACUM OFFICINALE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2409_4d4f24f6-ffb4-44de-bc20-a3bf2704fec3 57955-2409 HUMAN OTC DRUG Aller-Detox Caffeine Adrenalinum, Caffeinum, Chamomilla, Coffea cruda, Coffea tosta, Ephedra vulgaris, Ferrum metallicum, Ilex paraguariensis, Kali phosphoricum, Kali phosphoricum, Paullinia sorbilis, Saccharum officinale, Sterculia acuminata, Sulphuricum acidum, Thea sinensis LIQUID ORAL 20140321 UNAPPROVED HOMEOPATHIC King Bio Inc. ARABICA COFFEE BEAN; CAFFEINE; COFFEA ARABICA SEED, ROASTED; COLA ACUMINATA SEED; EPHEDRA DISTACHYA FLOWERING TWIG; EPINEPHRINE; GREEN TEA LEAF; ILEX PARAGUARIENSIS LEAF; IRON; MATRICARIA RECUTITA; PAULLINIA CUPANA SEED; POTASSIUM PHOSPHATE, DIBASIC; SUCROSE; SULFURIC ACID 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2511_92cec070-b2e1-4c75-ac1e-3e89c206003c 57955-2511 HUMAN OTC DRUG Egotistical Ferrum metallicum, Gratiola officinalis, Hamamelis virginiana, Helianthus annuus, Hottonia palustris, flos, Lachesis mutus, Lilium tigrinum, Lycopodium clavatum, Moschus, Palladium metallicum, Platinum metallicum, Staphysagria, Sulphur, Rhus toxicodendron, Veratrum album, Viola odorata LIQUID ORAL 20131024 UNAPPROVED HOMEOPATHIC King Bio Inc. DELPHINIUM STAPHISAGRIA SEED; GRATIOLA OFFICINALIS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HELIANTHUS ANNUUS FLOWERING TOP; HOTTONIA PALUSTRIS FLOWER; IRON; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; PALLADIUM; PLATINUM; SULFUR; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2531_9e6b0af0-a17f-459a-9110-4050877d2af4 57955-2531 HUMAN OTC DRUG Self Pity Aesculus hippocastanum, flos, Aloe socotrina, Arnica montana, Arsenicum album, Borago officinalis, Calcarea carbonica, Carpinus betulus, flos, Chamomilla, Gelsemium sempervirens, Graphites, Ipecacuanha, Kali sulphuricum, Mentha piperita, Nitricum acidum, Olea europaea, flos, Onosmodium virginianum, Palladium metallicum, Pulsatilla, Sepia, Tropaeolum majus, Ulmus procera, flos, Viola tricolor LIQUID ORAL 20131030 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS HIPPOCASTANUM FLOWER; ALOE; ARNICA MONTANA; ARSENIC TRIOXIDE; BORAGE; CARPINUS BETULUS FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; IPECAC; MATRICARIA RECUTITA; MENTHA PIPERITA; NITRIC ACID; OLEA EUROPAEA FLOWER; ONOSMODIUM VIRGINIANUM WHOLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PALLADIUM; POTASSIUM SULFATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; TROPAEOLUM MAJUS; ULMUS PROCERA FLOWERING TWIG; VIOLA TRICOLOR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2561_7c0a1433-eb95-46d3-af9b-df1466b8e502 57955-2561 HUMAN OTC DRUG Insecurity Aesculus hippocastanum, flos, Antimonium crudum, Argentum nitricum, Baryta aceticua, Baryta carbonica, Borago officinalis, Cytisus scoparius, Digitalis purpurea, Graphites, Kali iodatum, Larix decidua, flos, Lycopodium clavatum, Petroleum, Sambucus nigra, Verbascum thapsus LIQUID ORAL 20140109 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS HIPPOCASTANUM FLOWER; ANTIMONY TRISULFIDE; BARIUM ACETATE; BARIUM CARBONATE; BORAGE; CYTISUS SCOPARIUS FLOWERING TOP; DIGITALIS; GRAPHITE; KEROSENE; LARIX DECIDUA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; POTASSIUM IODIDE; SAMBUCUS NIGRA FLOWERING TOP; SILVER NITRATE; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2703_0a8cc3b2-c14e-4a17-85bc-9102dee8c992 57955-2703 HUMAN OTC DRUG Allergies Rocky MTNS. U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Agrimonia eupatoria, Agrostemma githago, Ailanthus glandulosus, Allium cepa, Cortisone aceticum, Cynodon dactylon, Equisetum hyemale, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucasa nasalis suis, Natrum muriaticum, Platanus, Populus candicans, RNA, Sabadilla, Solidago virgaurea LIQUID ORAL 20140701 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; AGRIMONIA EUPATORIA; AGROSTEMMA GITHAGO SEED; AILANTHUS ALTISSIMA FLOWERING TWIG; CORTICOTROPIN; CORTISONE ACETATE; CYNODON DACTYLON; EPINEPHRINE; EQUISETUM HYEMALE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; ONION; PLATANUS OCCIDENTALIS WHOLE; POPULUS BALSAMIFERA LEAF BUD; POTASSIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA NASAL MUCOSA 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2705_ee8fcb31-1b52-45a5-9e00-09cbe5afeba0 57955-2705 HUMAN OTC DRUG Allergies Southwest U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Asarum canadense, Cortisone aceticum, Eupatorium aromaticum, Euphrasia officinalis, Fraxinus americana, Galphimia glauca, Helianthus annuus, Histaminum hydrochloricum, juniperus virginiana, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Plantago major, RNA, Rumex crispus, Sabadilla, Senecio jacobaea LIQUID ORAL 20140513 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; AGERATINA AROMATICA ROOT; ASARUM CANADENSE ROOT; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; FRAXINUS AMERICANA BARK; GALPHIMIA GLAUCA FLOWERING TOP; HELIANTHUS ANNUUS FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JACOBAEA VULGARIS; JUNIPERUS VIRGINIANA TWIG; ONION; PLANTAGO MAJOR; POTASSIUM CHLORIDE; RUMEX CRISPUS ROOT; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2707_9c22c3e6-903f-46b9-834d-9f1e4a9ca518 57955-2707 HUMAN OTC DRUG Allergies Northeast U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, agraphis nutans, Allium cepa, Collinsonia canadensis, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Salvia officinalis, Tanacetum vulgare Trifolium pratense, Vinca minor LIQUID ORAL 20140701 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; COLLINSONIA CANADENSIS ROOT; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; HYACINTHOIDES NON-SCRIPTA; ONION; POTASSIUM CHLORIDE; RUMEX CRISPUS ROOT; SACCHAROMYCES CEREVISIAE RNA; SAGE; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; TANACETUM VULGARE TOP; TRIFOLIUM PRATENSE FLOWER; VINCA MINOR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2708_eb9afce7-53e9-402e-a2fe-37f12c25f1ca 57955-2708 HUMAN OTC DRUG Allergies Great Lakes U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemisiaefolia, Chelidonium majus, Chenopodium vulvaria, Cichorium intybus, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, hedera helix, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Pulsatilla nuttalliana, RNa, Sabadilla, Teucrium scorodonia LIQUID ORAL 20140620 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; AMBROSIA ARTEMISIIFOLIA; ANEMONE PATENS; CHELIDONIUM MAJUS; CHENOPODIUM VULVARIA; CHICORY ROOT; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; ONION; POTASSIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; TEUCRIUM SCORODONIA FLOWERING TOP 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2750_b369b832-70eb-4f6d-a938-d01a0094e71e 57955-2750 HUMAN PRESCRIPTION DRUG Shy Aesculus carnea, flos, allium sativum, Ambra grisea, Baryta carbonica, Ceratostigma willmottianum, flos, Conium maculatum, Graphites, Helianthus annuus, Juglans regia, flos, Kali phosphoricum, Larix decidua, flos, Mancinella, Pulsatilla, Viola odorata, Xanthoxylum fraxineum LIQUID ORAL 20130528 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS CARNEA FLOWER; AMBERGRIS; BARIUM CARBONATE; CERATOSTIGMA WILLMOTTIANUM FLOWER; CONIUM MACULATUM FLOWERING TOP; GARLIC; GRAPHITE; HELIANTHUS ANNUUS FLOWERING TOP; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; JUGLANS REGIA FLOWERING TOP; LARIX DECIDUA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; VIOLA ODORATA; ZANTHOXYLUM AMERICANUM BARK 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 57955-2760_b224558b-b1a2-4a13-b537-2306c36b4d0e 57955-2760 HUMAN OTC DRUG Procrastination Aesculus hippocastanum, flos, Agrimonia eupatoria, flos, Angelica archangelica, Capsicum annuum, Carpinus betulus, flos, Chamomilla, Clematis vitalba, flos, Cocculus indicus, Glonoinum, Hoang-nan, Juglans regia, flos, Larix decidua, flos, Lonicera caprifolium, flos, Mimulus guttatus, flos, Nux vomica, Olea europaea, flos, Oxytropis lambertii, Picricum acidum, Rhus toxicodendron, Scleranthus annuus, flos, Secale cornatum, Stellaria media, Sulphuricum acidum LIQUID ORAL 20130615 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWER; ANAMIRTA COCCULUS SEED; ANGELICA ARCHANGELICA ROOT; CAPSICUM; CARPINUS BETULUS FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM; CLEMATIS VITALBA FLOWER; JUGLANS REGIA FLOWERING TOP; LARIX DECIDUA FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWERING TOP; MATRICARIA RECUTITA; MIMULUS GUTTATUS FLOWERING TOP; NITROGLYCERIN; OLEA EUROPAEA FLOWER; OXYTROPIS LAMBERTII TOP; PICRIC ACID; SCLERANTHUS ANNUUS FLOWERING TOP; STELLARIA MEDIA; STRYCHNOS NUX-VOMICA SEED; STRYCHNOS WALLICHIANA BARK; SULFURIC ACID; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2770_17cdce45-b956-40df-9827-b9bf99bcad7b 57955-2770 HUMAN OTC DRUG Indecision Chamomilla, Clematis vitalba, flos, Croton tiglium, Curare, Dulcamara, Graphites, Ignatia amara, Iodium, Lathyrus sativus, Lonicera caprifolium, flos, Millefolium, Muriaticum acidum, Rosa damascena, Saccharum officinale, Silicea, Stigmata maidis LIQUID ORAL 20130808 UNAPPROVED HOMEOPATHIC King Bio Inc. ACHILLEA MILLEFOLIUM; CLEMATIS VITALBA FLOWER; CORN SILK; CROTON TIGLIUM SEED; GRAPHITE; HYDROCHLORIC ACID; IODINE; LATHYRUS SATIVAS SEED; LONICERA CAPRIFOLIUM FLOWERING TOP; MATRICARIA RECUTITA; ROSA DAMASCENA FLOWERING TOP; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; STRYCHNOS IGNATII SEED; SUCROSE; TUBOCURARINE CHLORIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2771_a93ce4db-bf06-4509-9a66-ff92c5267e59 57955-2771 HUMAN OTC DRUG Indecision Chamomilla, Clematis vitalba, flos, Croton tiglium, Curare, Dulcamara, Graphites, Ignatia amara, Iodium, Lathyrus sativus, Lonicera caprifolium, flos, Millefolium, Muriaticum acidum, Rosa damascena, Saccharum officinale, Silicea, Stigmata maidis LIQUID ORAL 20140604 UNAPPROVED HOMEOPATHIC King Bio Inc. ACHILLEA MILLEFOLIUM; CLEMATIS VITALBA FLOWER; CORN SILK; CROTON TIGLIUM SEED; GRAPHITE; HYDROCHLORIC ACID; IODINE; LATHYRUS SATIVAS SEED; LONICERA CAPRIFOLIUM FLOWERING TOP; MATRICARIA RECUTITA; ROSA DAMASCENA FLOWERING TOP; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; STRYCHNOS IGNATII SEED; SUCROSE; TUBOCURARINE CHLORIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2781_4a1afb8b-312c-479a-b818-402dcc7bec54 57955-2781 HUMAN OTC DRUG Nostalgia Aurum metallicum, Berberis aquifolium, Calcarea carbonica, Capsicum annuum, Carbo animalis, Eupatorium purpureum, Geranium maculatum, Helleborus niger, Juglans regia, flos, Lobelia cardinalis, Lonicera caprifolium, flos, Mancinella, Melilotus officinalis, Mercurius vivus, Millefolium, Pulsatilla, Rhus toxicodendron, Silicea, Stigmata maidis, Viola odorata LIQUID ORAL 20140606 UNAPPROVED HOMEOPATHIC King Bio Inc. ACHILLEA MILLEFOLIUM; CAPSICUM; CARBO ANIMALIS; CORN SILK; EUTROCHIUM PURPUREUM ROOT; GERANIUM MACULATUM ROOT; GOLD; HELLEBORUS NIGER ROOT; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; JUGLANS REGIA FLOWERING TOP; LOBELIA CARDINALIS; LONICERA CAPRIFOLIUM FLOWERING TOP; MAHONIA AQUIFOLIUM ROOT BARK; MELILOTUS OFFICINALIS TOP; MERCURY; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-2790_73fdbc3e-a072-49e1-a60c-7d834d23a9ff 57955-2790 HUMAN OTC DRUG Aversion to Exertion Adrenalinum, Agaricus muscarius, Aloe socotrina, Bovista, Calcarea carbonica, Carpinus betulus, flos, Chelidonium majus, Cocculus indicus, Helonias dioica, Hydrofluoricum acidum, Kali phosphoricum, Mimosa pudica, Rosmarinus officinalis, Sulphur, Tanacetum vulgare, Taraxacum officinale, Tropaeolum majus LIQUID ORAL 20130615 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; AMANITA MUSCARIA FRUITING BODY; ANAMIRTA COCCULUS SEED; CARPINUS BETULUS FLOWERING TOP; CHAMAELIRIUM LUTEUM ROOT; CHELIDONIUM MAJUS; EPINEPHRINE; HYDROFLUORIC ACID; LYCOPERDON UTRIFORME FRUITING BODY; MIMOSA PUDICA LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM PHOSPHATE, DIBASIC; ROSMARINUS OFFICINALIS FLOWERING TOP; SULFUR; TANACETUM VULGARE TOP; TARAXACUM OFFICINALE; TROPAEOLUM MAJUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-3020_6a5825c4-b6f7-4641-987a-581c23a168a1 57955-3020 HUMAN OTC DRUG Alcoholism Aesculus hippocastanum, flos, Agrimonia eupatoria, flos, Apocynum cannabinum, Arsenicum album, Asarum europaeum, Avena sativa, Capsicum annuum, Carboneum sulphuratum, Gelsumium sempervirens, Helianthus annuus, Juglans regia, flos, Lonicera caprifolium, flos, Naja tripudians, Paullinia sorbilis. LIQUID ORAL 20130626 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWER; APOCYNUM CANNABINUM ROOT; ARSENIC TRIOXIDE; ASARUM EUROPAEUM; AVENA SATIVA FLOWERING TOP; CAPSICUM; CARBON DISULFIDE; GELSEMIUM SEMPERVIRENS ROOT; HELIANTHUS ANNUUS FLOWERING TOP; JUGLANS REGIA FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWERING TOP; NAJA NAJA VENOM; PAULLINIA CUPANA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-3021_d653a799-e136-4865-b20b-bd76d5c46149 57955-3021 HUMAN OTC DRUG Alcoholism Aesculus hippocastanum, flos, Agrimonia eupatoria, flos, Apocynum cannabinum, Arsenicum album, Asarum europaeum, Avena sativa, Capsicum annuum, Carboneum sulphuratum, Gelsemium sempervirens, Helianthus annuus, Juglans regia, flos, Lonicera caprifolium, flos, Naja tripudians, Paullinia sorbilis LIQUID ORAL 20131125 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWER; APOCYNUM CANNABINUM ROOT; ARSENIC TRIOXIDE; ASARUM EUROPAEUM; AVENA SATIVA FLOWERING TOP; CAPSICUM; CARBON DISULFIDE; GELSEMIUM SEMPERVIRENS ROOT; HELIANTHUS ANNUUS FLOWERING TOP; JUGLANS REGIA FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWERING TOP; NAJA NAJA VENOM; PAULLINIA CUPANA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-3031_c6168f3b-34da-42cd-9eee-b2fddadafa8f 57955-3031 HUMAN OTC DRUG Smoke Control Aesculus hippocastanum, flos, Agrimonia eupatoria, flos, Caladium seguinum, Capsicum annuum, Daphne indica, Eugenia jambosa, Helianthus annuus, Juglans regia, flos, Kali phosphoricum, Lobelia inflata, Lonicera caprifolium, flos, Nicotinum, Nux vomica, Plantago major, Saccharum officinale, Staphysagria, Tabacum LIQUID ORAL 20140521 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWER; CAPSICUM; DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; HELIANTHUS ANNUUS FLOWERING TOP; JUGLANS REGIA FLOWERING TOP; LOBELIA INFLATA; LONICERA CAPRIFOLIUM FLOWERING TOP; NICOTINE; PLANTAGO MAJOR; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; SUCROSE; SYZYGIUM JAMBOS SEED; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-3320_19186842-adea-4b26-bb96-48f65617c049 57955-3320 HUMAN OTC DRUG Probiotic Restoration Aethusa cynapium, Allium sativum, Baptisia tinctoria, Capsicum annuum, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colcynthis, Condurango, Gambogia, Gratiola officinalis, Lac vaccinum, Lacticum acidum, Natrum carbonicum, Nux vomica, Podophyllum peltatum, Sepia, Silicea LIQUID ORAL 20131001 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; AETHUSA CYNAPIUM; BAPTISIA TINCTORIA ROOT; CAPSICUM; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COLLINSONIA CANADENSIS ROOT; COW MILK; GAMBOGE; GARLIC; GRATIOLA OFFICINALIS; LACTIC ACID, DL-; MARSDENIA CONDURANGO BARK; MATRICARIA RECUTITA; PODOPHYLLUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-4000_18d7a8c6-5e51-4510-a7fd-8be1e50d5a0a 57955-4000 HUMAN OTC DRUG Soothing Advanced Arnica Arnica montana, Arnica montana, radix CREAM TOPICAL 20120718 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; ARNICA MONTANA ROOT 6; 6 [hp_X]/85g; [hp_X]/85g 57955-4001_eaad90db-0f86-4480-a667-5620fe52d38e 57955-4001 HUMAN OTC DRUG Cooling Acute Pain Relief Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Cimicifuga racemosa, Cobaltum metallicum, Gnaphalium polycephalum, Hypericum perforatum, Kali carbonicum, Kali phosphoricum, Magnesia phosphorica, Oxalicum acidum, Phosphorus, Rhus toxicodendron, Ruta graveolens, Zincum metallicum CREAM TOPICAL 20120718 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; COBALT; HORSE CHESTNUT; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g 57955-4020_bfc666ea-c9f7-472e-8aee-0c79615e7871 57955-4020 HUMAN OTC DRUG Irritable BowelCare Aloe socotrina, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colocynthis, Croton tiglium, Gelsemium sempervirens, Gratiola officinalis, Nux vomica,Phosphoricum acidum, Podophyllum peltatum and Veratrum album LIQUID ORAL 20110213 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; ALOE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COLLINSONIA CANADENSIS ROOT; CROTON TIGLIUM SEED; GELSEMIUM SEMPERVIRENS ROOT; GRATIOLA OFFICINALIS; MATRICARIA RECUTITA; PHOSPHORIC ACID; PODOPHYLLUM; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; mL/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-4022_0da2e08d-c16f-46cc-9540-04f66efb1747 57955-4022 HUMAN OTC DRUG HeartburnCare Abies nigra, Condurango, Conium maculatum, Iris versicolor, Magnesia carbonica, Robinia pseudoacacia LIQUID ORAL 20120213 UNAPPROVED HOMEOPATHIC King Bio Inc. CONIUM MACULATUM FLOWERING TOP; IRIS VERSICOLOR ROOT; MAGNESIUM CARBONATE; MARSDENIA CONDURANGO BARK; PICEA MARIANA RESIN; ROBINIA PSEUDOACACIA BARK 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-4043_7a14315d-f8ef-429f-ad05-321d0cf9726e 57955-4043 HUMAN OTC DRUG AllergyCare llium cepa, Ambrosia artemisiaefolia, Arum triphyllum, Arundo mauritanica, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Natrum muriaticum, RNA, Sabadilla and Wyethia helenioides LIQUID ORAL 20120511 UNAPPROVED HOMEOPATHIC King Bio Inc. AMBROSIA ARTEMISIIFOLIA; ARISAEMA TRIPHYLLUM ROOT; ARUNDO PLINIANA ROOT; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; ONION; POTASSIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; WYETHIA HELENIOIDES ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-4044_700e7133-57d9-448d-acea-69b016f368cd 57955-4044 HUMAN OTC DRUG AsthmaCare Safecare LIQUID ORAL 20120214 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; AMMONIUM CARBONATE; ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; BROMINE; CHLORINE; EPINEPHRINE; ERIODICTYON CALIFORNICUM LEAF; EUCALYPTUS GLOBULUS LEAF; GRINDELIA HIRSUTULA FLOWERING TOP; LOBELIA INFLATA; PHOSPHORUS; QUEBRACHO BARK; SODIUM SULFATE; TRIFOLIUM PRATENSE FLOWER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; mL/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-4053_82250b3d-34b4-4eb1-b2d2-fa88a99926a7 57955-4053 HUMAN OTC DRUG RespiratoryCare Ammonium carbonicum, Antimonium tartaricum, Carbo vegetabilis, Chlorinum, Kali carbonicum, Lobelia inflata, Phosphorus, Silicea, and Stannum metallicum LIQUID ORAL 20120301 UNAPPROVED HOMEOPATHIC King Bio Inc ACTIVATED CHARCOAL; AMMONIUM CARBONATE; ANTIMONY POTASSIUM TARTRATE; CHLORINE; LOBELIA INFLATA; PHOSPHORUS; POTASSIUM CARBONATE; SILICON DIOXIDE; TIN 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-4199_1f518348-ce1f-4e65-bc53-2bbcd7730ee9 57955-4199 HUMAN OTC DRUG Multi-Strain FluCare Anas barbariae, hepatis et cordis extractum, Baptisia tinctoria, Bryonia, Cinchona officinalis, Dulcamara, Echinacea purpurea, Eucalyptus globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Influenzinum, Phytolacca decandra, Rhus toxicodendron, Sarcolacticum acidum, Sulphur, Wyethia helenioides, Zincum aceticum, Zincum muriaticum, Zincum oxydatum LIQUID ORAL 20120327 UNAPPROVED HOMEOPATHIC King Bio Inc. BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; CINCHONA OFFICINALIS BARK; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LACTIC ACID, L-; PHYTOLACCA AMERICANA ROOT; SOLANUM DULCAMARA TOP; SULFUR; TOXICODENDRON PUBESCENS LEAF; WYETHIA HELENIOIDES ROOT; ZINC ACETATE ANHYDROUS; ZINC CHLORIDE; ZINC OXIDE 10; 10; 35; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_C]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-4728_86bf8b39-4817-42ca-854b-53f9674c6829 57955-4728 HUMAN OTC DRUG Migraine Relief Gelsemium sempervirens, Iris versicolor, Kali carbonicum, Niccolum metallicum, Nux vomica, Sanguinaria canadensis, Spigelia anthelmia and Sulphur LIQUID ORAL 20130111 UNAPPROVED HOMEOPATHIC King Bio Inc. GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; NICKEL; POTASSIUM CARBONATE; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5002_aeddfde6-372e-45aa-b02e-5f5e750a29c6 57955-5002 HUMAN OTC DRUG Birth Ease Aletris farinosa, Apis mellifica, Arnica montana, Belladonna, Caulophyllum thalictroides, Chamomilla, Cimicifuga racemosa, Ferrum metallicum, Kali carbonicum, Sabina, Secale cornutum, Viburnum opulus LIQUID ORAL 20111028 UNAPPROVED HOMEOPATHIC King Bio, Inc. ALETRIS FARINOSA ROOT; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; CLAVICEPS PURPUREA SCLEROTIUM; IRON; JUNIPERUS SABINA LEAFY TWIG; MATRICARIA RECUTITA; POTASSIUM CARBONATE; VIBURNUM OPULUS BARK 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5003_0acc7098-1632-40a8-8744-2c8751ed18ef 57955-5003 HUMAN OTC DRUG Breast Inflammations and Discomforts Aconitum napellus, Bellis perennis, Bromium, Bryonia, Chamomilla, Conium maculatum, Iodium, Phellandrium aquaticum, Phytolacca decandra, Scrophularia nodosa and Silicea LIQUID ORAL 20120719 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; BELLIS PERENNIS; BROMINE; BRYONIA ALBA ROOT; CONIUM MACULATUM FLOWERING TOP; IODINE; MATRICARIA RECUTITA; OENANTHE AQUATICA FRUIT; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5005_75ae42de-8d9e-4916-8539-e8770ed44da3 57955-5005 HUMAN OTC DRUG FertiPlex Agnus castus, Apis Mellifica, Aurum Metallicum, Borax, Conium maculatum, Ferrum metallicum, Iodium, Lilium tigrinum, Lycopodium clavatum, Natrum muriaticum, Palladium Metallicum and Sepia LIQUID ORAL 20110826 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; CHASTE TREE; CONIUM MACULATUM FLOWERING TOP; GOLD; IODINE; IRON; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; PALLADIUM; SEPIA OFFICINALIS JUICE; SODIUM BORATE; SODIUM CHLORIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5009_c54a5587-f6f9-4033-b84f-8f59e95e149f 57955-5009 HUMAN OTC DRUG PMS Relief Apis mellifica, Chamomilla, Cimicifuga racemosa, Cyclamen europaeum, Helonias dioica, Ignatia amara, Lac caninum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Platinum metallicum, and Sepia LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; BLACK COHOSH; CANIS LUPUS FAMILIARIS MILK; CHAMAELIRIUM LUTEUM ROOT; CYCLAMEN PURPURASCENS TUBER; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; PLATINUM; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5015_55046600-ff63-4c80-9426-e8cc40df5d9e 57955-5015 HUMAN OTC DRUG Attention and Learning Enhancement Baryta carbonica, Calcarea carbonica, Ignatia amara, Lycopodium clavatum, Magnesia carbonica, Natrum carbonicum, Natrum muriaticum and Thuja occidentalis LIQUID ORAL 20111031 UNAPPROVED HOMEOPATHIC King Bio Inc. BARIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5016_1346f078-299d-473c-9297-83bd24e22e32 57955-5016 HUMAN OTC DRUG Paralixer Calcarea carbonica, Chenopodium anthelminticum, Cina, Croton tiglium, Filix mas, Gambogia, Granatum, Lycopodium clavatum, Mercurius corrosivus, Natrum phosphoricum, Santoninum, Senna, Spigelia anthelmia, Stannum metallicum, Tanacetum vulgare, Teucrium marum and Zingiber officinale LIQUID ORAL 20110913 UNAPPROVED HOMEOPATHIC King Bio Inc. ARTEMISIA CINA PRE-FLOWERING TOP; CROTON TIGLIUM SEED; DRYOPTERIS FILIX-MAS ROOT; DYSPHANIA AMBROSIOIDES; GAMBOGE; GINGER; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PUNICA GRANATUM ROOT BARK; SANTONIN; SENNA LEAF; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SPIGELIA ANTHELMIA; TANACETUM VULGARE TOP; TEUCRIUM MARUM; TIN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5018_47c56048-eb60-44eb-b462-f26055a8bbde 57955-5018 HUMAN OTC DRUG Teething Agaricus muscarius, Belladonna, Calcarea carbonica, Calcarea phosphorica, Chamomilla, Ferrum phosphoricum, Kreosotum and Zincum metallicum LIQUID ORAL 20120103 UNAPPROVED HOMEOPATHIC King Bio Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ATROPA BELLADONNA; FERROSOFERRIC PHOSPHATE; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; WOOD CREOSOTE; ZINC 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5019_dd110d56-03ef-4cb7-bc6e-cf462173af76 57955-5019 HUMAN OTC DRUG Constipation Relief Alumina, Bellis perennis, Causticum, Collinsonia canadensis, Hydrastis canadensis, Lac defloratum, Natrum muriaticum, Nux vomica, Plumbum metallicum, Sepia LIQUID ORAL 20131004 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; LEAD; SEPIA OFFICINALIS JUICE; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5024_4e1ef388-6cab-4298-972b-0b848666c24e 57955-5024 HUMAN OTC DRUG Indigestion Relief Antimonium crudum, Argentum nitricum, Carbo vegetabilis, Chelidonium majus, Cinchona officinalis, Graphites, Hydrastis canadensis, Ipecacuanha, Kali carbonicum, Lycopodium clavatum, Nux vomica, Pulsatilla LIQUID ORAL 20140505 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; GOLDENSEAL; GRAPHITE; IPECAC; LYCOPODIUM CLAVATUM SPORE; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5028_cbc2d11c-ab17-46cc-a0dd-03d034e33942 57955-5028 HUMAN OTC DRUG Migraine Relief Natural Medicine LIQUID ORAL 20110628 UNAPPROVED HOMEOPATHIC King Bio Inc. CLAVICEPS PURPUREA SCLEROTIUM; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; NICKEL; NITROGLYCERIN; POTASSIUM CARBONATE; SANGUINARIA CANADENSIS ROOT; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5030_028d6fb8-8e26-4be5-9b77-f21e3771a4f2 57955-5030 HUMAN OTC DRUG Sciatici Freee Natural Medicine LIQUID ORAL 20110613 UNAPPROVED HOMEOPATHIC Kingbio AMMONIUM CHLORIDE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CAPSICUM; CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; HORSE CHESTNUT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; STRYCHNOS IGNATII SEED; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57955-5031_e925b621-712a-4834-bfa3-2d935c0dff68 57955-5031 HUMAN OTC DRUG Sporting Edge Arnica montana, Kali carbonicum, Kali phosphoricum, Lacticum acidum, natrum phosphoricum, Quebracho, Rhus toxicodendron, Sarcolacticum acidum, Zincum oxydatum LIQUID ORAL 20120501 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; LACTIC ACID, DL-; LACTIC ACID, L-; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TOXICODENDRON PUBESCENS LEAF; ZINC OXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5038_cdb60a72-9643-4fad-b709-8c54613d86d8 57955-5038 HUMAN OTC DRUG Grief and Guilt Reliever Aurum metallicum, Cocculus indicus, Colocynthis, Gelsemium sempervirens, Hyoscyamus niger, Ignatia amara, Lachesis mutus, Natrum muriaticum, Phosphoricum acidum, Pulsatilla, Staphysagria LIQUID ORAL 20120301 UNAPPROVED HOMEOPATHIC King Bio Inc. ANAMIRTA COCCULUS SEED; CITRULLUS COLOCYNTHIS FRUIT PULP; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; GOLD; HYOSCYAMUS NIGER; LACHESIS MUTA VENOM; PHOSPHORIC ACID; PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5041_f4e79a19-02c3-4eda-8fce-95151278d767 57955-5041 HUMAN OTC DRUG Acne Clear Natural Medicine LIQUID ORAL 20110921 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY POTASSIUM TARTRATE; ASTERIAS RUBENS; CALCIUM SULFIDE; IRON; POTASSIUM BROMIDE; SANGUINARIA CANADENSIS ROOT; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CHLORIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5042_5601c2f5-69f6-406f-8846-ead13ab78979 57955-5042 HUMAN OTC DRUG Allergy Food andChemical Relief Allium sativum, Anacardium orientale, Apis mellifica, Gambogia, Mercurius solubilis, Natrum carbonicum, Nitricum acidum, Nux vomica, Phosphorus, Pulsatilla and Sulphur LIQUID ORAL 20120504 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; GAMBOGE; GARLIC; MERCURIUS SOLUBILIS; NITRIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5043_e9f34e51-9509-418a-bb3d-67f76c6e56fd 57955-5043 HUMAN OTC DRUG Allergy and Hay Fever Reliever Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Arum triphyllum, Arundo mauritanica, Euphrasia officinalis, Naphthalinum, Natrum muriaticum, Sabadilla and Wyethia helenioides LIQUID ORAL 20120105 UNAPPROVED HOMEOPATHIC King Bio Inc AMBROSIA ARTEMISIIFOLIA; ARISAEMA TRIPHYLLUM ROOT; ARSENIC TRIOXIDE; ARUNDO PLINIANA ROOT; EUPHRASIA STRICTA; NAPHTHALENE; ONION; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; WYETHIA HELENIOIDES ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5045_c059e92b-4246-4acc-b3b5-4236b9f61fa3 57955-5045 HUMAN OTC DRUG Bladder Incontinence Belladonna, Bellis perennis, Benzoicum acidum, Causticum, Equisetum hyemale, Lycopodium clavatum, Phosphorus, Plantago major, Rhus aromatica, Sepia LIQUID ORAL 20120313 UNAPPROVED HOMEOPATHIC King Bio Inc. ATROPA BELLADONNA; BELLIS PERENNIS; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5049_7c01fd7d-5d1e-4b4b-bef4-289f799daa85 57955-5049 HUMAN OTC DRUG Hair and Nails Formula Adrenalinum, Antimonium crudum, Arsenicum album, Natrum muriaticum, Phosphoricum acidum, Phosphorus, Pix liquida, Selenium metallicum, Silicea, Sulphur, Thuja occidentalis LIQUID ORAL 20140717 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; EPINEPHRINE; PHOSPHORIC ACID; PHOSPHORUS; PINE TAR; SELENIUM; SILICON DIOXIDE; SODIUM CHLORIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5053_fb705177-286b-486c-9cc8-21369e6774f2 57955-5053 HUMAN OTC DRUG Lungs and Bronchial Relief Natural Medicine LIQUID ORAL 20111011 UNAPPROVED HOMEOPATHIC King Bio Inc ACTIVATED CHARCOAL; AMMONIUM CARBONATE; ANTIMONY ARSENATE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BROMINE; CHLORINE; LOBELIA INFLATA; POTASSIUM CARBONATE; SULFURIC ACID; TIN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5055_d04fe7db-783e-4d2f-b0d2-0430f68bb6d9 57955-5055 HUMAN OTC DRUG Nausea and Motion Sickness Argentum nitricum, Bryonia, Cocculus indicus, Glonoinum, Lac defloratum, Petroleum, Staphysaria, Tabacum LIQUID ORAL 20120705 UNAPPROVED HOMEOPATHIC King Bio Inc. ANAMIRTA COCCULUS SEED; BRYONIA ALBA ROOT; DELPHINIUM STAPHISAGRIA SEED; KEROSENE; NITROGLYCERIN; SILVER NITRATE; SKIM MILK; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5058_5ae1397a-b983-4100-9754-5b10543b60f9 57955-5058 HUMAN OTC DRUG Sore Throat and Laryngitis Aconitum napellus, Antimonium crudum, Arum triphyllum, Borax, Causticum, Ferrum phosphoricum, Graphites, Hepar sulphuris calcareum, Kali bichromicum, Phosphorus, Selenium metallicum, Spongia tosta LIQUID ORAL 20140627 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARISAEMA TRIPHYLLUM ROOT; CALCIUM SULFIDE; CAUSTICUM; FERROSOFERRIC PHOSPHATE; GRAPHITE; PHOSPHORUS; POTASSIUM DICHROMATE; SELENIUM; SODIUM BORATE; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5059_50eba846-f187-4233-9561-60d8380c800f 57955-5059 HUMAN OTC DRUG Wart Freee Antimonium crudum, Causticum, Dulcamare, Kali muriaticum, Nitricum acidum, Sabina, Staphysagria, Sulphur, Thuja occidentalis LIQUID ORAL 20140120 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY TRISULFIDE; CAUSTICUM; DELPHINIUM STAPHISAGRIA SEED; JUNIPERUS SABINA LEAFY TWIG; NITRIC ACID; POTASSIUM CHLORIDE; SOLANUM DULCAMARA TOP; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5061_b7d735e8-f3db-4b55-9146-99cfa2b3587a 57955-5061 HUMAN OTC DRUG Blood and Kidney Detox Arsenicum album, Baptisia tinctoria, Carbo vegetabilis, Chininum sulphuricum, Cinchona officinalis, Conium maculatum, Echinacea purpurea, Ferrum metallicum, Hydrastis canadensis, Kali chloricum, Mercurius corrosivus and Serum anguillae LIQUID ORAL 20110626 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; ANGUILLA ROSTRATA BLOOD SERUM; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; ECHINACEA PURPUREA; GOLDENSEAL; IRON; MERCURIC CHLORIDE; POTASSIUM CHLORATE; QUININE SULFATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5062_d3640c9f-c3e7-4bf1-9a44-aff3da2b4a7d 57955-5062 HUMAN OTC DRUG Liver Detox Arsenicum album, Baptisia tinctoria, Berberis vulgaris, Bryonia, Carduus marianus, Chelidonium majus, Chionanthus virginica, Cinchona officinalis, Lycopodium clavatum, Manganum muriaticum, Natrum sulphuricum, Nux vomica, Phosphorus, Sulphur, Taraxacum officinale LIQUID ORAL 20120917 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; MANGANESE CHLORIDE; PHOSPHORUS; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5063_671a98eb-f79f-4bb6-aead-8dd3b9f558c1 57955-5063 HUMAN OTC DRUG Lymph Detox Belladonna, Calcarea iodata, Conium maculatum, Echinacea purpurea, Hepar sulphuris calcareum, Kali iodatum, Kali muriaticum, Mercurius vivus, Phytolacca decandra, Pulsatilla, Ricinus communis, Scrophularia nodosa, Solidago virgaurea, and sulphur iodatum LIQUID ORAL 20111031 UNAPPROVED HOMEOPATHIC King Bio Inc. ATROPA BELLADONNA; CALCIUM IODIDE; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; ECHINACEA PURPUREA; MERCURY; PHYTOLACCA AMERICANA ROOT; POTASSIUM CHLORIDE; POTASSIUM IODIDE; PULSATILLA VULGARIS; RICINUS COMMUNIS SEED; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR IODIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5064_7986b37e-0859-46c4-b9f0-4b35882ba14c 57955-5064 HUMAN OTC DRUG Artery Cholesterol and BP Aurum metallicum, Aurum muriaticum natronatum, Baryta carbonica, Baryta muriatica, Calcarea flourica, Ceanothus americanus, Cholesterinum, Glonoinum, Plumbum iodatum, Strophanthus LIQUID ORAL 20120319 UNAPPROVED HOMEOPATHIC King Bio Inc. BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CALCIUM FLUORIDE; CEANOTHUS AMERICANUS LEAF; CHOLESTEROL; GOLD; LEAD IODIDE; NITROGLYCERIN; SODIUM TETRACHLOROAURATE; STROPHANTHUS HISPIDUS SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5065_a6cad210-eab5-42b9-a990-f00d408d367e 57955-5065 HUMAN OTC DRUG Heart Regularity Apocynum cannabinum, Baryta carbonica, Cactus grandiflorus, Convallaria majalis, Cypripedium pubescens, Gelsemium sempervirens, Glonoinum, Naja tripudians, Phosphorus, Spigelia anthelmia and Spongia tosta LIQUID ORAL 20111011 UNAPPROVED HOMEOPATHIC King Bio Inc. APOCYNUM CANNABINUM ROOT; BARIUM CARBONATE; CONVALLARIA MAJALIS; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5070_a2a21b19-0b14-4533-be85-4c8258519414 57955-5070 HUMAN OTC DRUG Bone Strengthener Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Equisetum hyemale, Hekla lava, Phosphorus, and silicea LIQUID ORAL 20120130 UNAPPROVED HOMEOPATHIC King Bio Inc. CALCIUM FLUORIDE; EQUISETUM HYEMALE; HEKLA LAVA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5071_2973136a-4ddb-4a68-9918-f79c743011cb 57955-5071 HUMAN OTC DRUG ChemoClenz Arsenicum album, Cadmium sulphuricum, Ipecacuanha, Nux vomica, Phosphoricum acidum, Phosphorus, Strontium carbonicum, Tabacum, Uranium nitricum. LIQUID ORAL 20111026 UNAPPROVED HOMEOPATHIC King Bio, Inc. ARSENIC TRIOXIDE; CADMIUM SULFATE; IPECAC; PHOSPHORIC ACID; PHOSPHORUS; STRONTIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; URANYL NITRATE HEXAHYDRATE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5077_2ca1e4fc-ec67-46e9-9ebf-222a416f8a9a 57955-5077 HUMAN OTC DRUG Bug Away Natural Medicine LIQUID ORAL 20110805 UNAPPROVED HOMEOPATHIC King Bio Inc. ANHYDROUS CITRIC ACID; APIS MELLIFERA; DAPHNE MEZEREUM BARK; DELPHINIUM STAPHISAGRIA SEED; HELIANTHEMUM CANADENSE; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; POTASSIUM NITRATE; PULEX IRRITANS; PULSATILLA VULGARIS; SULFUR; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5080_0c0bd556-a792-477e-925d-5309fe5324b4 57955-5080 HUMAN OTC DRUG Smoke Control Natural Medicine LIQUID ORAL 20111011 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; LOBELIA INFLATA; NICOTINE; PHENOL; PLANTAGO MAJOR; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; SUCROSE; SYZYGIUM JAMBOS SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5082_17ffb26d-0f8a-4358-bca0-715a7f586853 57955-5082 HUMAN OTC DRUG Vaccinoplex Aconitum napellus, Apis mellifica, Chamomilla, Hypericum perforatum, Ledum palustre, Pulsatilla, Silicea, Thuja occidentalis LIQUID ORAL 20111026 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MATRICARIA RECUTITA; PULSATILLA VULGARIS; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5085_cd04a41c-792e-45d1-885d-5e9e65ad2037 57955-5085 HUMAN OTC DRUG No Sweat Anti Perspirant Antimonium tartaricum, Calcarea carbonica, Cinchona officinalis, Mercurius solubilis, Mercurius vivus, Pilocarpus, Phosphoricum acidum, Sambucus nigra, Silicea and Sulphuricum acidum LIQUID ORAL 20120301 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY POTASSIUM TARTRATE; CINCHONA OFFICINALIS BARK; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PILOCARPUS JABORANDI LEAF; SAMBUCUS NIGRA FLOWERING TOP; SILICON DIOXIDE; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5087_78a5f2fb-e4de-4204-84c3-c274d158e147 57955-5087 HUMAN OTC DRUG Scar Freee Arnica montana, Calcarea fluorica, Calcarea phosphorica, Calendula officinalis, Graphites, Hydrofluoricum acidum, Phytolacca decandra, Sabina, Silicea, Thiosinaminum and Thuja occidentalis LIQUID ORAL 20120217 UNAPPROVED HOMEOPATHIC King Bio Inc. ALLYLTHIOUREA; ARNICA MONTANA; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; GRAPHITE; HYDROFLUORIC ACID; JUNIPERUS SABINA LEAFY TWIG; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5099_4a2d2423-6ccd-40f4-9137-8716c216df23 57955-5099 HUMAN OTC DRUG Fears and Nightmares Aconitum napellus, Aurum bromatum, Calcarea carbonica, Chamomilla, Cina, Ignatia amara, Kali bromatum, Lycopodium clavatum, Paeonia officinalis, Phosphorus, Stramonium, Sulphur LIQUID ORAL 20140401 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ARTEMISIA CINA PRE-FLOWERING TOP; DATURA STRAMONIUM; GOLD TRIBROMIDE; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PAEONIA OFFICINALIS ROOT; PHOSPHORUS; POTASSIUM BROMIDE; STRYCHNOS IGNATII SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5113_7f16b35e-1649-4f23-b66e-6474624a3d88 57955-5113 HUMAN OTC DRUG Hangover Relief Arsenicum album, Asarum europaeum, Avena sativa, Bryonia, Capsicum annuum, Carbo vegetabilis, Carboneum sulphuratum, Cinchona officinalis, Gelsemium sempervirens, Nux vomica, Paullinia sorbilis, Sulphuricum acidum LIQUID ORAL 20140718 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; ASARUM EUROPAEUM; AVENA SATIVA FLOWERING TOP; BRYONIA ALBA ROOT; CAPSICUM; CARBON DISULFIDE; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; PAULLINIA CUPANA SEED; STRYCHNOS NUX-VOMICA SEED; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5114_43d69ea8-6fa0-4107-8d28-09ad35ae3926 57955-5114 HUMAN OTC DRUG Newborn Tonic Aconitum napellus, Bovista, Bryonia, Chamomilla, Cinchona officinalis, Lupulinum, Mercurius vivus, Myrica cerifera, Natrum sulphuricum, Phosphorus, Sepia LIQUID ORAL 20140320 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; HOPS; LYCOPERDON UTRIFORME FRUITING BODY; MATRICARIA RECUTITA; MERCURY; MORELLA CERIFERA ROOT BARK; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SODIUM SULFATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5120_8fa93979-5a05-40f3-85ea-c2cf4e037174 57955-5120 HUMAN OTC DRUG Snore Control Bromium, Chamomilla, Cinchona officinalis, Cuprum metallicum, Helleborus niger, Laurocerasus, Nux vomica, Phosphoricum acidum, Rhus toxicodendron, Silicea. Stramonium, Zincum metallicum LIQUID ORAL 20140630 UNAPPROVED HOMEOPATHIC King Bio Inc. BROMINE; CINCHONA OFFICINALIS BARK; COPPER; DATURA STRAMONIUM; HELLEBORUS NIGER ROOT; MATRICARIA RECUTITA; PHOSPHORIC ACID; PRUNUS LAUROCERASUS LEAF; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5121_740fb39e-aac8-4d62-aa01-1c5d29c529e9 57955-5121 HUMAN OTC DRUG Swollen Glands Relief Astacus fluviatilis, Baryta iodata, Calcarea iodata, Cistus Canadensis, Clematis erecta, Coniinum, Iodium, Lacticum acidum, Mercurius iodatus ruber, Mercurius vivus, Phytolacca decandra, Scrophularia nodosa, Spongia tosta LIQUID ORAL 20120705 UNAPPROVED HOMEOPATHIC King Bio Inc. ASTACUS ASTACUS; BARIUM IODIDE; CALCIUM IODIDE; CLEMATIS RECTA FLOWERING TOP; CONIINE; HELIANTHEMUM CANADENSE; IODINE; LACTIC ACID, DL-; MERCURIC IODIDE; MERCURY; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5126_7d45da22-804b-4186-a037-646e3ca30352 57955-5126 HUMAN OTC DRUG Jet Lag and Shift Change Cocculus indicus, Colchicum autumnale, Gelsemium sempervirens, Juniperus communis, Kali carbonicum, Kali phosphoricum, Nux vomica, Passiflora incarnata, Phosphoricum acidum, Phosphorus LIQUID ORAL 20131008 UNAPPROVED HOMEOPATHIC King Bio Inc. ANAMIRTA COCCULUS SEED; COLCHICUM AUTUMNALE BULB; GELSEMIUM SEMPERVIRENS ROOT; JUNIPER BERRY; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5128_cd16f062-f068-41f1-b7ae-cd02b7aeb72d 57955-5128 HUMAN OTC DRUG Appetite Enhancer Alumina, Antimonium crudum, Arsenicum album, Asarum europaeum, Baptisia tinctoria, Carbolicum acidum, Chininum arsenicicum, Cocculus indicus, Lecithin, Picricum acidum, Pulsatilla, Rhus toxicodendron, Silicea and Sulphur LIQUID ORAL 20121031 UNAPPROVED HOMEOPATHIC King Bio. Inc. ALUMINUM OXIDE; ANAMIRTA COCCULUS SEED; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ASARUM EUROPAEUM; BAPTISIA TINCTORIA ROOT; EGG PHOSPHOLIPIDS; PHENOL; PICRIC ACID; PULSATILLA VULGARIS; QUININE ARSENATE; SILICON DIOXIDE; SULFUR; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5129_d022ae1e-174b-40c1-94a4-52c22130b6a6 57955-5129 HUMAN OTC DRUG Athletes Foot Fighter Anatherum muricatum, Alumina, Apis mellifica, Arsenicum album, Butyricum acidum, Hydrocotyle asiatica, Mezereum, Petroleum, Petroleum, rhus toxicodendron, Sepia, Silicea and Sulphur LIQUID ORAL 20110913 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BUTYRIC ACID; CENTELLA ASIATICA; DAPHNE MEZEREUM BARK; KEROSENE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; TOXICODENDRON PUBESCENS LEAF; VETIVERIA ZIZANIOIDES ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5130_20e9bc60-fd1a-42e6-8c55-01dd737121cf 57955-5130 HUMAN OTC DRUG Odor Freee Baptisia tinctoria, Carbo animalis, Guaiacum, Lycopodium clavatum, Mercurius solubilis, Nitricum acidum, Petroleum, Sepia, Silicea, Sulphur and Thuja occidentalis LIQUID ORAL 20110913 UNAPPROVED HOMEOPATHIC King Bio Inc. BAPTISIA TINCTORIA ROOT; CARBO ANIMALIS; GUAIACUM OFFICINALE RESIN; KEROSENE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NITRIC ACID; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5133_796f9581-e6ea-4dbd-829e-3b1f6f5c069f 57955-5133 HUMAN OTC DRUG Muscle Maximizer Adrenalinum, Alfalfa, Avena sativa, Baryta carbonica, Baryta iodate, Baryta muriatica, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Lycopodium clavatum, Thuja occidentalis LIQUID ORAL 20111028 UNAPPROVED HOMEOPATHIC King Bio Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; BARIUM IODIDE; CALCIUM FLUORIDE; EPINEPHRINE; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; THUJA OCCIDENTALIS LEAFY TWIG; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5134_b30632ee-4f56-47de-9aa2-6b57b056fc89 57955-5134 HUMAN OTC DRUG Sinus Relief Natural Medicine LIQUID ORAL 20110906 UNAPPROVED HOMEOPATHIC King Bio Inc APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; CITRULLUS COLOCYNTHIS FRUIT PULP; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; LEMNA MINOR; MERCURY; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; STRYCHNOS IGNATII SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5142_2b99ea5e-272e-46e3-98e6-b165b1b45962 57955-5142 HUMAN OTC DRUG Childrens Growth and Development Alfalfa, Avena sativa, Baryta carbonica, Baryta Iodata, Baryta muriatica, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Lycopodium clavatum, Thuja occidentalis LIQUID ORAL 20120822 UNAPPROVED HOMEOPATHIC King Bio Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; BARIUM IODIDE; CALCIUM FLUORIDE; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; THUJA OCCIDENTALIS LEAFY TWIG; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5146_c7a8c2cc-bc2a-488d-86cb-89760061defc 57955-5146 HUMAN OTC DRUG Tummy Aches Natural Medicine LIQUID ORAL 20111109 UNAPPROVED HOMEOPATHIC King Bio Inc. ANAMIRTA COCCULUS SEED; BRYONIA ALBA ROOT; DELPHINIUM STAPHISAGRIA SEED; KEROSENE; NITROGLYCERIN; SILVER NITRATE; SKIM MILK; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; mL/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5149_824033ce-024d-4287-9b69-fdc94a21e9f1 57955-5149 HUMAN OTC DRUG Constitutional Enhancer Aconitum napellus, Arsenicum album, Baryta carbonica, Cantharis, Gelsemium sempervirens, Graphites, Hydrastis canadensis, Kali iodatum, Lachesis mutus, Lycopodium clavatum, Mercurius vivus, Natrum muriaticum, Nux vomica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhus toxicodendron, Sepia, Silicea and Sulphur LIQUID ORAL 20120321 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; GRAPHITE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MERCURY; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM IODIDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5150_ffaaa0e2-444a-4856-81ee-063b42c8b958 57955-5150 HUMAN OTC DRUG Good Mood Enhancer Natural Medicine LIQUID ORAL 20110824 UNAPPROVED HOMEOPATHIC King Bio Inc. AVENA SATIVA FLOWERING TOP; BLACK COHOSH; CINCHONA OFFICINALIS BARK; GOLD; HYPERICUM PERFORATUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM BROMIDE; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS IGNATII SEED; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; mL/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5151_3df551ac-2f65-4950-b4e3-4b563fb76ac3 57955-5151 HUMAN OTC DRUG Eye Stress Agaricus muscarius, Argentum nitricum, Calcarea carbonica, Carbo vegetabilis, Gelsemium sempervirens, Graphites, Mephitis mephitica, Natrum muriaticum, Onosmodium virginianum, Phosphorus, Physostigma venenosum, Pilocarpus LIQUID ORAL 20140717 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; AMANITA MUSCARIA FRUITING BODY; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; MEPHITIS MEPHITIS ANAL GLAND FLUID; ONOSMODIUM VIRGINIANUM WHOLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED; PILOCARPUS JABORANDI LEAF; SILVER NITRATE; SODIUM CHLORIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5152_6082dd4c-f6a3-421c-bc8c-f1133691939b 57955-5152 HUMAN OTC DRUG Fears and Phobias Abelmoschus, Aconitum napellus, Argentum nitricum, Arsenicum album, Calcarea carbonica, Cinchona officinalis, Cocculus indicus, Gelsemium sempervirens, Kali arsenicosum, Lilium tigrinum, Lycopodium clavatum, Phosphorus, Pulsatilla and Stramonium LIQUID ORAL 20111011 UNAPPROVED HOMEOPATHIC King Bio Inc. ABELMOSCHUS MOSCHATUS SEED; ACONITUM NAPELLUS; ANAMIRTA COCCULUS SEED; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; DATURA STRAMONIUM; GELSEMIUM SEMPERVIRENS ROOT; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM ARSENITE ANHYDROUS; PULSATILLA VULGARIS; SILVER NITRATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5153_0eaa6e75-6de5-41ca-b252-e6c306121bca 57955-5153 HUMAN OTC DRUG Headache Relief Belladonna, Bryonia, Capsicum annuum, Chininum arsenicosum, Coffea cruda, Gelsemium sempervirens, Glonoinum, Ignatia amara, Kali bichromicum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Sanguinaria canadensis, Spigelia anthelmia, Sulphur. SPRAY ORAL 20120308 UNAPPROVED HOMEOPATHIC King Bio Inc. ARABICA COFFEE BEAN; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAPSICUM; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; NITROGLYCERIN; POTASSIUM DICHROMATE; QUININE ARSENITE; SANGUINARIA CANADENSIS ROOT; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5158_a4e542fa-307a-422c-b70d-63578f304217 57955-5158 HUMAN OTC DRUG Colic Relief Aethusa cynapium, Alumina, Belladonna, Borax, Chamomilla, Colocynthis, Dioscorea villosa, Ipecacuanha, Magnesia phosphorica, Natrum phosphorica, Nux vomica, Pulsatilla, Senna, Silicea, Valeriana officinalis LIQUID ORAL 20120112 UNAPPROVED HOMEOPATHIC King Bio, Inc. AETHUSA CYNAPIUM; ALUMINUM OXIDE; ATROPA BELLADONNA; DIOSCOREA VILLOSA TUBER; IPECAC; LEAD; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; PULSATILLA VULGARIS; SENNA LEAF; SILICON DIOXIDE; SODIUM BORATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED; VALERIAN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5159_a7c67c4d-cb4b-4897-8217-8ca8b693a8e2 57955-5159 HUMAN OTC DRUG Childrens Fever Reliever Aceticum acidum, Aconitum napellus, Aesculus hippocastanum, Agaricus muscarius, Baptisia tinctoria, Belladonna, Bryonia, Chamomilla, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Pulsatilla, Rhus toxicodendron, Sambucus nigra, Sulphur and Veratrum viride. LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETIC ACID; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; HORSE CHESTNUT; MATRICARIA RECUTITA; PULSATILLA VULGARIS; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; TOXICODENDRON PUBESCENS LEAF; VERATRUM VIRIDE ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5160_ddeecfa0-b4da-4d14-8f6c-2ad8a878d083 57955-5160 HUMAN OTC DRUG Fever Reliever Aceticum acidum, Aconitum napellus, Aesculus hippocastanum, Agaricus muscarius, Baptisia tinctoria, Belladonna, Bryonia, Chamomilla, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Pulsatilla, Rhus toxicodendron, Sambucus nigra, Sulphur, Veratrum viride LIQUID ORAL 20110913 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETIC ACID; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; HORSE CHESTNUT; MATRICARIA RECUTITA; PULSATILLA VULGARIS; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; TOXICODENDRON PUBESCENS LEAF; VERATRUM VIRIDE ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5163_a6e8768e-61be-4186-a786-288d8cc9d1cb 57955-5163 HUMAN OTC DRUG Anxiety and Nervousness Natural Medicine LIQUID ORAL 20110711 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ALFALFA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; GOLD; HOPS; HYDROCHLORIC ACID; MATRICARIA RECUTITA; NITROGLYCERIN; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; POTASSIUM ARSENITE ANHYDROUS; POTASSIUM PHOSPHATE, DIBASIC; SILVER NITRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS IGNATII SEED; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5164_4c282179-b231-4582-92b1-665d5e75f4a1 57955-5164 HUMAN OTC DRUG Allergy and Red Eye Relief Aconitum napellus, Allium cepa, Ambrosia artemisiaefolia, Apis mellifica, Arsenicum album, Belladonna, Cactus grandiflorus, Dulcamara, Euphrasia officinalis, Gelsemium sempervirens, Graphites, Hamamelis virginiana, Hepar sulphuris calcareum, Kali iodatum, Mercurius vivus, Natrum muriaticum, Pulsatilla, Rhus toxicodendron, Ruta graveolens,Sabadilla, Sulphur, Thuja occidentalis, Zincum metallicum LIQUID ORAL 20140422 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CALCIUM SULFIDE; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MERCURY; ONION; POTASSIUM IODIDE; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; SELENICEREUS GRANDIFLORUS STEM; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5165_4a0255cd-804a-445e-ba6c-2bd6c839252a 57955-5165 HUMAN OTC DRUG Cold Sores and Herpes Apis mellifica, Arsenicum album, Borax, Capsicum annuum, Graphites, Mentha piperita, Mezereum, Natrum muriaticum, Nux vomica, Petroleum, Ranunculus bulbosus, and Rhus toxicodendron LIQUID ORAL 20120831 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; CAPSICUM; DAPHNE MEZEREUM BARK; GRAPHITE; KEROSENE; MENTHA PIPERITA; RANUNCULUS BULBOSUS; SODIUM BORATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5168_a232f2d7-14ab-4baf-b320-85b5fd5a782f 57955-5168 HUMAN OTC DRUG Skin Irritations and Itch Relief Natural Medicine LIQUID ORAL 20111104 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ANAGALLIS ARVENSIS; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; CAUSTICUM; FAGOPYRUM ESCULENTUM; GIANT PUFFBALL; GRAPHITE; HYDROCHLORIC ACID; KEROSENE; MUCUNA PRURIENS FRUIT TRICHOME; NERIUM OLEANDER LEAF; PINE TAR; POTASSIUM CHLORIDE; RADIUM BROMIDE; SELENIUM; SULFUR; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5181_3a2e16f3-db8b-4c5d-8461-f4ba8c917070 57955-5181 HUMAN OTC DRUG Appetite and Weight with P.H.A.T. Natural Medicine LIQUID ORAL 20110617 UNAPPROVED HOMEOPATHIC King Bio Inc. AGRIMONIA EUPATORIA FLOWER; ANTIMONY TRISULFIDE; BOS TAURUS HYPOTHALAMUS; CASTANEA SATIVA FLOWER; CORTICOTROPIN; CORTISONE ACETATE; DELPHINIUM STAPHISAGRIA SEED; EPINEPHRINE; FUCUS VESICULOSUS; NERIUM OLEANDER LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; SCHOENOCAULON OFFICINALE SEED; SEMECARPUS ANACARDIUM JUICE; SUS SCROFA PITUITARY GLAND; THYROID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57955-5194_292b8133-de74-481d-9625-29928ecfbec6 57955-5194 HUMAN OTC DRUG Multi Strain Flu Relief Natural Medicine LIQUID ORAL 20111107 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; CAUSTICUM; CINCHONA OFFICINALIS BARK; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A/B VIRUS IMMUNOSERUM RABBIT; LACTIC ACID, L-; PHYTOLACCA AMERICANA ROOT; SULFUR; TOXICODENDRON PUBESCENS LEAF; WYETHIA HELENIOIDES ROOT; ZINC ACETATE ANHYDROUS; ZINC CHLORIDE; ZINC OXIDE 10; 10; 10; 35; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5205_acabf1c2-6405-42de-999a-a38260a3f4e3 57955-5205 HUMAN OTC DRUG Nuts and Seeds Intolerances Adrenalinum, Chelidonium majus, Cucurbita pepo, semen, Histaminum hydrochloricum, Hydrastis canadensis, Ricinus communis, Sabadilla LIQUID ORAL 20131125 UNAPPROVED HOMEOPATHIC King Bio Inc. CHELIDONIUM MAJUS; EPINEPHRINE; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; PUMPKIN SEED; RICINUS COMMUNIS SEED; SCHOENOCAULON OFFICINALE SEED 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5275_346d3027-cc47-41a2-a7ff-aadb0b669d0f 57955-5275 HUMAN OTC DRUG Ear Ringing Arnica montana, Calcarea carbonica, Chenopodium anthelminticum, Chininum salicylicum, Cimicifuga racemosa, Coffea tosta, Kali iodatum, Kalmia latifolia, Magnesia carbonica, Manganum aceticum, Manganum carbonicum, Mercurius vivus, Natrum salicylicum, Salicylicum acidum, Thiosinaminum, Thyroidinum LIQUID ORAL 20131008 UNAPPROVED HOMEOPATHIC King Bio Inc. ALLYLTHIOUREA; ARNICA MONTANA; BLACK COHOSH; COFFEA ARABICA SEED, ROASTED; DYSPHANIA AMBROSIOIDES; KALMIA LATIFOLIA LEAF; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; MANGANESE CARBONATE; MERCURY; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM IODIDE; QUININE SALICYLATE; SALICYLIC ACID; SODIUM SALICYLATE; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5283_e22cebc9-1170-47dd-a15e-358af9319daa 57955-5283 HUMAN OTC DRUG Climate Adaptation Cold and Dry Aconitum napellus, Agaricus muscarius, Asarum europaeum, Aurum metallicum, Bryonia, Camphora, Causticum, Hepar sulphuris calcareum, Hypothalamus, Kali carbonicum, Petroleum, Secale cornutum, Sepia, Thyroidinum LIQUID ORAL 20140116 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; ASARUM EUROPAEUM; BOS TAURUS HYPOTHALAMUS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAMPHOR (NATURAL); CAUSTICUM; CLAVICEPS PURPUREA SCLEROTIUM; GOLD; KEROSENE; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5287_38269b85-4592-4d32-b582-009b7498170c 57955-5287 HUMAN OTC DRUG Weather Changes Alumen, Benzoicum acidum, Cadmium sulphuricum, Chelidonium majus, Colchicum autumnale, Dulcamara, Hypothalamus, Manganum aceticum, Mercurius solubilis, Natrum muriaticum, Nitricum acidum, Phosphorus, Ranunculus bulbosus, Rhododendron chrysanthum, Thyroidinum LIQUID ORAL 20130730 UNAPPROVED HOMEOPATHIC King Bio Inc. BENZOIC ACID; BOS TAURUS HYPOTHALAMUS; CADMIUM SULFATE; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; MANGANESE ACETATE TETRAHYDRATE; MERCURIUS SOLUBILIS; NITRIC ACID; PHOSPHORUS; POTASSIUM ALUM; RANUNCULUS BULBOSUS; RHODODENDRON AUREUM LEAF; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5315_67af2571-6b32-4cb6-ac42-23973f94c88f 57955-5315 HUMAN OTC DRUG Childrens Earache Relief Aconitum napellus, Allium capa, Apis mellifica, Belladonna, Calcarea carbonica, Capsicum annuum, Causticum, Chamomilla, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali muriaticum, Mercurius dulcis, Mercurius solubilis, Plantago major, and Silicea LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ATROPA BELLADONNA; CALCIUM SULFIDE; CALOMEL; CAPSICUM; CAUSTICUM; FERROSOFERRIC PHOSPHATE; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; ONION; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PLANTAGO MAJOR; POTASSIUM CHLORIDE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5318_9bc9865d-2d57-49f8-a687-2dcafc9dba14 57955-5318 HUMAN OTC DRUG Childrens Appetite Enhancer Alumina, Antimonium crudum, Arsenicum album, Asarum europaeum, Baptisia Tinctoria, Carbolicum acidum, Chininum arsenicosum, Cocculus indicus, Lecithin, Picricum acidum, Pulsatilla, Rhus toxicodendron, Silicea, and Sulphur LIQUID ORAL 20120904 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; ANAMIRTA COCCULUS SEED; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ASARUM EUROPAEUM; BAPTISIA TINCTORIA ROOT; EGG PHOSPHOLIPIDS; PHENOL; PICRIC ACID; PULSATILLA VULGARIS; QUININE ARSENITE; SILICON DIOXIDE; SULFUR; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; mL/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5319_00674758-a35a-45c4-98b5-46d5e55758e9 57955-5319 HUMAN OTC DRUG Foul Bowel Ammonium carbonicum, Asafoetida, Baptisia tinctoria, Carbo vegetabilis, Carbolicum acidum, Graphites, Kreosotum, Mercurius corrosivus, Oleander, Phosphorus, Rhus toxicodendron and Zincum metallicum LIQUID ORAL 20120227 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; AMMONIUM CARBONATE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; GRAPHITE; MERCURIC CHLORIDE; NERIUM OLEANDER LEAF; PHENOL; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; WOOD CREOSOTE; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5361_d0804a29-1a7c-4f38-9a95-84e8da99d74c 57955-5361 HUMAN OTC DRUG Jet Lag and Shift Change Alumina, Bryonia, Calcarea iodata, Cantharis, Carduus benedictus, Carduus marianus, Chelidonium majus, Cinchona officinalis, Cynara scolymus, Dioscorea villosa, Hepar sulphuris calcareum, Iris versicolor, Juniperus communis, Kali iodatum, Mercurius corrosivus, Mercurius vivus, Natrum carbonicum, Nux vomica, Plumbum metallicum, Ptelea trifoliata, Ricinus communis, Robinia pseudoacacia, Serum anguillae, Solidago virgaurea, Sulphur, Sulphuricum acidum, Taraxacum officinale LIQUID ORAL 20131008 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; ANGUILLA ROSTRATA BLOOD SERUM; BRYONIA ALBA ROOT; CALCIUM IODIDE; CALCIUM SULFIDE; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; DIOSCOREA VILLOSA TUBER; IRIS VERSICOLOR ROOT; JUNIPER BERRY; LEAD; LYTTA VESICATORIA; MERCURIC CHLORIDE; MERCURY; POTASSIUM IODIDE; PTELEA TRIFOLIATA BARK; RICINUS COMMUNIS SEED; ROBINIA PSEUDOACACIA BARK; SILYBUM MARIANUM SEED; SODIUM CARBONATE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR; SULFURIC ACID; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5510_6eaadfc9-05f9-44ba-a466-b68e5ee8429a 57955-5510 HUMAN OTC DRUG Male Libido Natural Medicine LIQUID ORAL 20110614 UNAPPROVED HOMEOPATHIC King Bio Inc ARNICA MONTANA; BARIUM CARBONATE; CHASTE TREE; DIEFFENBACHIA SEGUINE; LYCOPODIUM CLAVATUM SPORE; NUPHAR LUTEUM ROOT; ONOSMODIUM VIRGINIANUM ROOT; PHOSPHORIC ACID; POTASSIUM BROMIDE; SELENIUM; STRYCHNOS NUX-VOMICA SEED; TRINITROPHENOL 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57955-5515_0605baee-c3b1-47ba-91e7-f90f9d731f68 57955-5515 HUMAN OTC DRUG Female Libido Natural Medicine LIQUID ORAL 20111130 UNAPPROVED HOMEOPATHIC King Bio Inc. ALETRIS FARINOSA ROOT; BERBERIS VULGARIS ROOT BARK; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; GRAPHITE; IRON; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; ONOSMODIUM VIRGINIANUM WHOLE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5566_8cea1747-2a73-465d-bde6-71a94a89eb54 57955-5566 HUMAN OTC DRUG Varicose Veins Natural Medicine LIQUID ORAL 20111011 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; ARNICA MONTANA; CALCIUM FLUORIDE; CLAVICEPS PURPUREA SCLEROTIUM; COLLINSONIA CANADENSIS ROOT; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SILYBUM MARIANUM SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5639_37af2092-75dc-4021-9a00-a7b8de308c37 57955-5639 HUMAN OTC DRUG Sleep Aid Aconitum napellus, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis,Aesculus hippocastanum, flos LIQUID ORAL 20110715 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; AESCULUS HIPPOCASTANUM FLOWER; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; AVENA SATIVA FLOWERING TOP; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; CYPRIPEDIUM PARVIFOLUM ROOT; HYOSCYAMUS NIGER; PASSIFLORA INCARNATA FLOWER; PULSATILLA VULGARIS; STRYCHNOS IGNATII SEED; VALERIAN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5851_3bb43abb-c5dc-4423-a77d-57b1800d57eb 57955-5851 HUMAN OTC DRUG 9-1-1 Stress Control Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Clematis erecta, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Passiflora incarnata, Phosphorous, Rhus toxicodendron, Sulphur, Symphytum officinale and Veratrum album,Clematis vitalba, flos, Impatiens glandulfera, flos, Ornithogalum Umbellatum, flos and Prunus cerasifera, flos. LIQUID ORAL 20111003 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS RECTA FLOWERING TOP; CLEMATIS VITALBA FLOWER; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PASSIFLORA INCARNATA FLOWER; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; STRYCHNOS IGNATII SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5930_8c67f8c5-8e9a-408b-94e1-7e4ed2e4700d 57955-5930 HUMAN OTC DRUG Mental Calm Natural Medicine LIQUID ORAL 20111128 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM FEROX ROOT; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; EPINEPHRINE; FERULA SUMBUL ROOT; PHOSPHORUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA; SILVER NITRATE; THYROID, UNSPECIFIED; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5956_4189f7eb-468d-4d02-994f-668b855f1564 57955-5956 HUMAN OTC DRUG Mental Alertness for Seniors Natural Medicine LIQUID ORAL 20111205 UNAPPROVED HOMEOPATHIC King Bio Inc. ALETRIS FARINOSA ROOT; ALUMINUM OXIDE; AVENA SATIVA FLOWERING TOP; CARPINUS BETULUS FLOWERING TOP; CHASTE TREE; CLEMATIS VITALBA FLOWER; CONIUM MACULATUM FLOWERING TOP; EGG PHOSPHOLIPIDS; LEAD; NUTMEG; OLEA EUROPAEA FLOWER; TRINITROPHENOL; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5979_17bf6204-e1bc-4c58-a374-369aea79c839 57955-5979 HUMAN OTC DRUG 9-1-1 Burnout Natural Medicine LIQUID ORAL 20111114 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS HIPPOCASTANUM FLOWER; ALFALFA; AMBERGRIS; ANHYDROUS CITRIC ACID; AVENA SATIVA FLOWERING TOP; BOS TAURUS HYPOTHALAMUS; CARBON MONOXIDE; CARPINUS BETULUS FLOWERING TOP; EGG PHOSPHOLIPIDS; EPINEPHRINE; GELSEMIUM SEMPERVIRENS ROOT; OLEA EUROPAEA FLOWER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-5984_36c9c3f8-490f-4425-8178-559ea487a54b 57955-5984 HUMAN OTC DRUG Advanced Arnica Natural Medicine LIQUID ORAL 20110927 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; ARNICA MONTANA ROOT 6; 6 [hp_X]/59mL; [hp_X]/59mL 57955-6000_fbc76b19-2608-4066-b620-5544315c8554 57955-6000 HUMAN OTC DRUG Advanced First Aid Natural Medicine LIQUID ORAL 20111115 UNAPPROVED HOMEOPATHIC King Bio Inc. ACHILLEA MILLEFOLIUM; ACTIVATED CHARCOAL; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6001_edce6486-afc9-41b1-9b38-f31fd9f73b7c 57955-6001 HUMAN OTC DRUG Indoor Air Pollution Detox Acetaldehyde, Ammonium causticum, Carboneum oxygenisatum, Chloroformum, Formalinum, Glycyrrhiza glabra, Hydrastis canadensis, Kali bichromicum, Lycopodium clavatum, Petroleum, Plumbum metallicum, Taraxacum officinale LIQUID ORAL 20140528 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETALDEHYDE; AMMONIA; CARBON MONOXIDE; CHLOROFORM; FORMALDEHYDE; GLYCYRRHIZA GLABRA; GOLDENSEAL; KEROSENE; LEAD; LYCOPODIUM CLAVATUM SPORE; POTASSIUM DICHROMATE; TARAXACUM OFFICINALE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6006_344b2382-d8af-4b7d-93e8-a2ff11c71207 57955-6006 HUMAN OTC DRUG Menopause Relief Amyl nitrosum, Calcarea carbonica, Caulophyllum thalictroides, Cimicifuga racemosa, Ferrum metallicum, Gelsemium sempervirens, Lachesis mutus, Pulsatilla, Sanguinaria canadensis, Sepia, Sulphur, Sulphuricum acidum SPRAY ORAL 20120307 UNAPPROVED HOMEOPATHIC King Bio Inc AMYL NITRITE; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; GELSEMIUM SEMPERVIRENS ROOT; IRON; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SULFUR; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6008_768b41a6-31db-484f-bbe5-969bae127b88 57955-6008 HUMAN OTC DRUG Morning Sickness Relief Natural Medicine LIQUID ORAL 20111026 UNAPPROVED HOMEOPATHIC King Bio Inc. ALETRIS FARINOSA ROOT; COLCHICUM AUTUMNALE BULB; IPECAC; IRON; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PRUNUS PERSICA FLOWER; PULSATILLA VULGARIS; PUMPKIN SEED; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6011_51f34091-4d79-4b84-b768-415a4505346e 57955-6011 HUMAN OTC DRUG Prostate Symptom Relief Baryta carbonica, Chimaphila umbellata, Clematis erecta, Conium maculatum, Digitalis purpurea, Ferrum picricum, Phosphoricum acidum, Sabal serrulata, Selenium metallicum, Staphysagria, Thuja occidentalis, Zincum metallicum LIQUID ORAL 20111031 UNAPPROVED HOMEOPATHIC King Bio Inc. BARIUM CARBONATE; CHIMAPHILA UMBELLATA; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; DIGITALIS; FERRIC PICRATE; PHOSPHORIC ACID; SAW PALMETTO; SELENIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6012_a067a3a9-2637-4d76-b66b-3dbbbdcbeb2d 57955-6012 HUMAN OTC DRUG Bed Wetting Natural Medicine LIQUID ORAL 20110729 UNAPPROVED HOMEOPATHIC King Bio Inc. ATROPA BELLADONNA; BELLIS PERENNIS; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6017_fd496dcd-d965-450b-9c17-29ab3b0818a6 57955-6017 HUMAN OTC DRUG Childrens Appetite Weight Natural Medicine LIQUID ORAL 20110729 UNAPPROVED HOMEOPATHIC King Bio Inc. AGRIMONIA EUPATORIA FLOWER; ANTIMONY TRISULFIDE; BOS TAURUS HYPOTHALAMUS; CASTANEA SATIVA FLOWER; CORTICOTROPIN; CORTISONE ACETATE; DELPHINIUM STAPHISAGRIA SEED; EPINEPHRINE; FUCUS VESICULOSUS; NERIUM OLEANDER LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; SCHOENOCAULON OFFICINALE SEED; SEMECARPUS ANACARDIUM JUICE; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6021_116793df-8ad4-421e-99f3-0f9483053ea5 57955-6021 HUMAN OTC DRUG Gout Symptom Formula Natural Medicine LIQUID ORAL 20111118 UNAPPROVED HOMEOPATHIC King Bio Inc. AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; FRAXINUS EXCELSIOR LEAF; LEDUM PALUSTRE TWIG; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6025_7cd473a8-b85f-4532-b2dd-76fd3067970a 57955-6025 HUMAN OTC DRUG Chicken Pox Symptom Relief Natural Medicine LIQUID ORAL 20111028 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ATROPA BELLADONNA; CALCIUM SULFIDE; CROTON TIGLIUM SEED; DAPHNE MEZEREUM BARK; ECHINACEA ANGUSTIFOLIA; GRAPHITE; MENTHA PIPERITA; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; SILICON DIOXIDE; SULFUR; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6030_3c806dbe-5051-43c1-b43f-8a4f6a1bbcc6 57955-6030 HUMAN OTC DRUG Sciatic Nerve Formula Aesculus hippocastanum, Ammonium muriaticum, Arsenicum album, Belladonna, Capsicum annuum, Causticum, Colchicum autumnale, Colocynthis, Gnaphalium polycephalum, Ignatia amara, Magnesia phosphoria, Rhus toxicodendron LIQUID ORAL 20131031 UNAPPROVED HOMEOPATHIC King Bio Inc. AMMONIUM CHLORIDE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CAPSICUM; CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; HORSE CHESTNUT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; STRYCHNOS IGNATII SEED; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6044_b55205dc-de78-4cc3-a2bb-7bdf698f30bb 57955-6044 HUMAN OTC DRUG Asthma Symptom Relief Natural Medicine LIQUID ORAL 20110927 UNAPPROVED HOMEOPATHIC King Bio Inc. .BETA.-SITOSTEROL; ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; EPINEPHRINE; ERIODICTYON CALIFORNICUM LEAF; EUCALYPTUS GLOBULUS LEAF; GRINDELIA HIRSUTULA FLOWERING TOP; IPECAC; LOBELIA INFLATA; SODIUM SULFATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6058_249d7977-e03f-4f00-a65f-256573272c37 57955-6058 HUMAN OTC DRUG Gallbladder Formula Barber vulgaris, Bryonia, Carduus marianus, Chelidonium majus, Cholesterinum, Cinchona officinalis, Colocynthis, Dioscorea villosa, Lycopodium clavatum, Natrum sulphuricum LIQUID ORAL 20110824 UNAPPROVED HOMEOPATHIC King Bio Inc. BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; LYCOPODIUM CLAVATUM SPORE; SILYBUM MARIANUM SEED; SODIUM SULFATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6100_30776465-5bf0-436b-9b22-104ed03d1fb6 57955-6100 HUMAN OTC DRUG Water Chemical Detox Natural Medicine LIQUID ORAL 20110822 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; BARIUM CARBONATE; BROMINE; CHIMAPHILA UMBELLATA; CHLORINE; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; HYDROFLUORIC ACID; KAOLIN; LEAD; LEMNA MINOR; NITRIC ACID; STRYCHNINE; TRIBASIC CALCIUM PHOSPHATE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6103_1afc71d4-b8ba-4654-9637-6f89c66bc11e 57955-6103 HUMAN OTC DRUG Cosmetic and Household Detox Natural Medicine LIQUID ORAL 20110822 UNAPPROVED HOMEOPATHIC King Bio Inc. BLATTA ORIENTALIS; EPINEPHRINE; FORMALDEHYDE; FUMARIA OFFICINALIS FLOWERING TOP; GLYCERIN; GRAPHITE; MAGNESIUM CHLORIDE; NITRIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SODIUM PYRUVATE; SULFUR; SUS SCROFA PITUITARY GLAND 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6145_997a74db-8459-4f06-8511-38d49c54e74d 57955-6145 HUMAN OTC DRUG Childrens Cough Relief Natural Medicine LIQUID ORAL 20111201 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; BROMINE; CALCIUM SULFIDE; COPPER; CORALLIUM RUBRUM EXOSKELETON; DROSERA ROTUNDIFOLIA; IODINE; MEPHITIS MEPHITIS ANAL GLAND FLUID; PROTORTONIA CACTI; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6147_9f54dfac-8473-4c44-94ab-156a6cb0f9c4 57955-6147 HUMAN OTC DRUG Anti-Aging and Wrinkles For Women Abrotanum, Adrenalinum, Adrenocorticotrophin, Alpha-ketoglutaricum acidum, Baryta carbonica, Calcarea fluorica, Citricum acidum, Coenzyme A, DNA, Ferrum metallicum, Glandula suprarenalis suis, Hekla lava, Helleborus niger, Hypothalamus, Lycopodium clavatum, oophorinum, RNA, Secale cornutum, Silicea, Thiaminum hydrochloricum LIQUID ORAL 20140421 UNAPPROVED HOMEOPATHIC King Bio Inc. .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ANHYDROUS CITRIC ACID; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CARBONATE; BOS TAURUS HYPOTHALAMUS; CALCIUM FLUORIDE; CLAVICEPS PURPUREA SCLEROTIUM; COENZYME A; CORTICOTROPIN; EPINEPHRINE; HEKLA LAVA; HELLEBORUS NIGER ROOT; HERRING SPERM DNA; IRON; LYCOPODIUM CLAVATUM SPORE; SACCHAROMYCES CEREVISIAE RNA; SILICON DIOXIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; THIAMINE HYDROCHLORIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6161_ad7f3126-9476-44c2-90f9-3453445aa116 57955-6161 HUMAN OTC DRUG Back Muscle and Joint Relief Natural Medicine LIQUID ORAL 20111011 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; COBALT; HORSE CHESTNUT; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6162_5ffce5f0-dec5-403e-ade1-f8ecce901659 57955-6162 HUMAN OTC DRUG Arthritis Pain and Joint Relief Natural Medicine LIQUID ORAL 20111117 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTAEA SPICATA ROOT; ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAUSTICUM; FORMIC ACID; HORSE CHESTNUT; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; mL/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6166_7168eca7-4412-4b83-bcbf-34eefa6fef34 57955-6166 HUMAN OTC DRUG Cough Relief Natural Medicine LIQUID ORAL 20111129 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; BROMINE; CALCIUM SULFIDE; COPPER; CORALLIUM RUBRUM EXOSKELETON; DROSERA ROTUNDIFOLIA; FERROSOFERRIC PHOSPHATE; IODINE; MEPHITIS MEPHITIS ANAL GLAND FLUID; PHOSPHORUS; POTASSIUM DICHROMATE; PROTORTONIA CACTI; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SANGUINARIA CANADENSIS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6205_7d5a865d-261a-4a43-a273-f1b7da106e03 57955-6205 HUMAN OTC DRUG Additive and Preservative Detox Natural Medicine LIQUID ORAL 20110825 UNAPPROVED HOMEOPATHIC King Bio Inc. FORMIC ACID; GAMBOGE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; SACCHARIN; SODIUM BICARBONATE; SODIUM NITRATE; SODIUM NITRITE; SODIUM SULFITE; STRYCHNOS NUX-VOMICA SEED 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; mL/59mL; mL/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6206_074c52b8-1f19-4c9c-9b59-bf5aff709505 57955-6206 HUMAN OTC DRUG Candida Abies canadensis, Allium cepa, Allium sativum, Aloe socotrina, Antimonium crudum, Asafoetida, Borax, Candida albicans, Candida parapsilosis, Carpinus betulus, flos, Ignatia amara, Lachesis mutus, Lycopodium clavatum, Malus pumila, flos, Olea europaea, flos, Phosphoricum acidum, Phytolacca decandra, Pulsatilla, Sabadilla, Sticta pulmonaria, Sulphur, Thuja occidentalis LIQUID ORAL 20130913 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; ANTIMONY TRISULFIDE; ASAFETIDA; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; CARPINUS BETULUS FLOWERING TOP; GARLIC; LACHESIS MUTA VENOM; LOBARIA PULMONARIA; LYCOPODIUM CLAVATUM SPORE; MALUS DOMESTICA FLOWER; OLEA EUROPAEA FLOWER; ONION; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; SODIUM BORATE; STRYCHNOS IGNATII SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TSUGA CANADENSIS FLOWER BUD 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL 57955-6227_1236fdf2-f917-4dc5-8db8-23fdcb94ac4e 57955-6227 HUMAN OTC DRUG Acid Detox Argentum nitricum, Calcarea carbonica, Calcarea silicata, Calcarea sulphurica, Carbo vegetabilis, Natrum carbonicum, Natrum phosphoricum, Nux vomica, Robinia pseudoacacia, Sulphuricum acidum LIQUID ORAL 20130411 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; CALCIUM SILICATE; CALCIUM SULFATE ANHYDROUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ROBINIA PSEUDOACACIA BARK; SILVER NITRATE; SODIUM CARBONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6235_b0336007-c36a-4bd5-8bb8-8db43c9af289 57955-6235 HUMAN OTC DRUG Restless Leg Symptom Relief Natural Medicine LIQUID ORAL 20110914 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; BUFO BUFO CUTANEOUS GLAND; CAUSTICUM; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LYCOSA TARANTULA; MATRICARIA RECUTITA; PULSATILLA VULGARIS; SULFUR; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUIT; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6286_651e46b7-3ba8-445b-9e64-67e4c22f8ead 57955-6286 HUMAN OTC DRUG Shellfish and Seafood Allergy Relief Adrenalinum, Belladonna, Bromium, Carbo animalis, Colchicum autumnale, Colocynthis, Histaminum hydrochloricum, Hydrastis canadensis, Kali carbonicum, Lycopodium clavatum, Mercurius solubilis, Pulsatilla, Urtica urens LIQUID ORAL 20111011 UNAPPROVED HOMEOPATHIC King Bio Inc. ATROPA BELLADONNA; BROMINE; CARBO ANIMALIS; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; EPINEPHRINE; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; URTICA URENS 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6321_e11d4b91-9420-4914-9de3-d91f27df1d43 57955-6321 HUMAN OTC DRUG Lower GI Relief Natural Medicine LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; AETHUSA CYNAPIUM; ALTHAEA OFFICINALIS ROOT; ALUMINUM OXIDE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BISMUTH SUBNITRATE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COLLINSONIA CANADENSIS ROOT; COW MILK; GAMBOGE; GRAPHITE; GRATIOLA OFFICINALIS; JUGLANS CINEREA BRANCH BARK/ROOT BARK; MATRICARIA RECUTITA; PODOPHYLLUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SKIM MILK; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; mL/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6490_834a29bd-32b6-409e-b6aa-e16adbec6eb9 57955-6490 HUMAN OTC DRUG Animal Hair and Dander Allergy Relief Natural Medicine LIQUID ORAL 20111123 UNAPPROVED HOMEOPATHIC King Bio Inc. ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; CERVUS ELAPHUS HORN OIL; HISTAMINE DIHYDROCHLORIDE; PHOSPHORUS; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-6493_8eb707ed-51e9-48ac-bb8a-5ebcff5a19d0 57955-6493 HUMAN OTC DRUG Dairy Allergy Relief Natural Medicine LIQUID ORAL 20111003 UNAPPROVED HOMEOPATHIC King Bio Inc. AETHUSA CYNAPIUM; CELERY SEED; COW MILK; GAMBOGE; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SKIM MILK; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-7019_54d7f696-08f4-4545-806b-676b07162c5b 57955-7019 HUMAN OTC DRUG Constipation Symptom Formula Alumina, Bellis perennis, Causticum, Collinsonia canadensis, Hydrastis canadensis, Lac defloratum, Natrum muriaticum, Nux vomica, Plumbum metallicum, Sepia LIQUID ORAL 20130220 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; LEAD; SEPIA OFFICINALIS JUICE; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-7020_96abc10e-b820-4680-ba38-5a3f535f67c8 57955-7020 HUMAN OTC DRUG Diarrhea Symptom Formula Aloe socotrina, Chamomilla, Cinchona officinalis, Colocynthis, Croton tiglium, Cuprum arsenicosum, Gelsemium sempervirens, Ipecacuanha, Nux vomica, Phosphoricum acidum, Podophyllum peltatum, veratrum album LIQUID ORAL 20130220 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; MATRICARIA RECUTITA; PHOSPHORIC ACID; PODOPHYLLUM; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-7023_3f50bf14-d8ee-45c0-bf28-593b713af3a3 57955-7023 HUMAN OTC DRUG Hemorrhoid Symptom Formula Aesculus hippocastanum, Aloe socotrina, Collinsonia canadensis, Hamamelis virginiana, Muriaticum acidum, Nux vomica, Paeonia officinalis, Ratanhia, Sepia, Sulphur LIQUID ORAL 20130218 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROCHLORIC ACID; KRAMERIA LAPPACEA ROOT; PAEONIA OFFICINALIS ROOT; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-7024_dc2de1ff-51b4-4b95-9806-95dab24ed040 57955-7024 HUMAN OTC DRUG Indigestion Symptom Formula Antimonium crudum, Argentum nitricum, Carbo vegetabilis, Chelidonium majus, Cinchona officinalis, Graphites, Hydrastis canadensis, Ipecacuanha, Kali carbonicum, Lycopodium clavatum, Nux vomica, Pulsatilla LIQUID ORAL 20130215 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; GOLDENSEAL; GRAPHITE; IPECAC; LYCOPODIUM CLAVATUM SPORE; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-7044_44c06d51-15cd-499c-ad1e-a00a442d5065 57955-7044 HUMAN OTC DRUG AsthmaCare Aconitum napellus, Adrenalinum, Ammonium carbonicum, Antimonium tartaricum, Aralia racemosa, Bromium, Chlorinum, Eriodictyon Californicum, Eucalyptus globulus, Grindelia, Lobelia inflata, Natrum sulphuricum, Phosphorus, Quebracho, Trifolium pratense LIQUID ORAL 20140401 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; AMMONIUM CARBONATE; ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; BROMINE; CHLORINE; EPINEPHRINE; ERIODICTYON CALIFORNICUM LEAF; EUCALYPTUS GLOBULUS LEAF; GRINDELIA HIRSUTULA WHOLE; LOBELIA INFLATA; PHOSPHORUS; SODIUM SULFATE; TRIFOLIUM PRATENSE FLOWER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-7145_d5617c61-e771-4a49-ad2e-3703118a154c 57955-7145 HUMAN OTC DRUG Childrens Cough Symptom Formula Aconitum napellus, Bromium, Coccus cacti, Corallium rubrum, Cuprum metallicum, Drosera, Hepar sulphuris calcareum, Iodium, Mephitis mephitica and Spongia tosta LIQUID ORAL 20130211 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; BROMINE; CALCIUM SULFIDE; COPPER; CORALLIUM RUBRUM EXOSKELETON; DROSERA ROTUNDIFOLIA; IODINE; MEPHITIS MEPHITIS ANAL GLAND FLUID; PROTORTONIA CACTI; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-7225_cf46eefd-f25d-4f0d-b8da-8f64cd3f4f41 57955-7225 HUMAN OTC DRUG Stye Symptom Formula Apis mellifica, Calcarea picrata, graphites, Hepar sulphuris calcareum, Juglans regia, Lycopodium clavatum, Pulsatilla, Silicea, Staphysagria, Sulfur, Thuja occidentalis LIQUID ORAL 20131204 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; CALCIUM PICRATE; CALCIUM SULFIDE; DELPHINIUM STAPHISAGRIA SEED; GRAPHITE; JUGLANS REGIA WHOLE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-7295_973ca5db-fc63-4973-b9c4-c64e2add0164 57955-7295 HUMAN OTC DRUG Ear Ringing Symptom Formula Arnica montana, Calcarea carbonica, Chenopodium anthelminticum, Chininum salicylicum, Cimicifuga racemosa, Coffea tosta, Kali iodatum, Kalmia latifolia, Magnesia carbonica, Manganum aceticum, Manganum carbonicum, Mercurius vivus, Natrum salicylicum, Salicylicum acidum, Thiosinaminum, Thyroidinum LIQUID ORAL 20131209 UNAPPROVED HOMEOPATHIC King Bio Inc. ALLYLTHIOUREA; ARNICA MONTANA; BLACK COHOSH; COFFEA ARABICA SEED, ROASTED; DYSPHANIA AMBROSIOIDES; KALMIA LATIFOLIA LEAF; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; MANGANESE CARBONATE; MERCURY; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM IODIDE; QUININE SALICYLATE; SALICYLIC ACID; SODIUM SALICYLATE; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-7301_f06f18f3-e1db-407a-93af-02610b88252c 57955-7301 HUMAN OTC DRUG Soothing Advanced Arnica Arnica montana, Arnica montana, radix CREAM TOPICAL 20140507 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; ARNICA MONTANA ROOT 6; 6 [hp_X]/85g; [hp_X]/85g 57955-7302_fe16318d-f62f-4c36-965d-97522ee8f97c 57955-7302 HUMAN OTC DRUG Cooling Acute Pain Relief Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Cimicifuga racemosa, Cobaltum metallicum, Gnaphalium polycephalum, Hypericum perforatum, Kali carbonicum, Kali phosphoricum, Magnesia phosphorica, Oxalicum acidum, Phosphorus, Rhus toxicodendron, Ruta graveolens, Zincum metallicum CREAM TOPICAL 20140219 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; COBALT; HORSE CHESTNUT; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g 57955-7304_126169a6-267e-4c2e-addf-49b63d447acf 57955-7304 HUMAN OTC DRUG Advanced Arnica Arnica montana, Arnica montana, radix LIQUID ORAL 20131217 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; ARNICA MONTANA ROOT 6; 6 [hp_X]/59mL; [hp_X]/59mL 57955-7800_582ac9b2-83a1-49bb-a6eb-c6cbb81403e2 57955-7800 HUMAN OTC DRUG Skin Tag Remover Thuja occidentalis LIQUID TOPICAL 20130426 UNAPPROVED HOMEOPATHIC King Bio Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/15mL 57955-8020_495b4e9e-13fa-48c0-94e0-d530ce913b8f 57955-8020 HUMAN OTC DRUG Candida High Potency 9 Aquaflora LIQUID ORAL 20110708 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; ANTIMONY TRISULFIDE; ASAFETIDA; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; CARPINUS BETULUS FLOWERING TOP; GARLIC; LACHESIS MUTA VENOM; LOBARIA PULMONARIA; LYCOPODIUM CLAVATUM SPORE; MALUS DOMESTICA FLOWER; OLEA EUROPAEA FLOWER; ONION; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; SODIUM BORATE; STRYCHNOS IGNATII SEED; SULFUR; THUJA OCCIDENTALIS LEAF; TSUGA CANADENSIS FLOWER BUD 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 57955-8058_381e7438-8fd7-4d0d-b122-b3d92cc692fe 57955-8058 HUMAN OTC DRUG Gallbladder Symptom Formula Berberis vulgaris, Bryonia alba, Carduus marianus, Chelidonium majus, Cholesterinum, Cinchona officinalis, Colocynthis, Dioscorea villosa, Lycopodium clavatum and Natrum sulphuricum LIQUID ORAL 20130220 UNAPPROVED HOMEOPATHIC King Bio Inc. BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; LYCOPODIUM CLAVATUM SPORE; SILYBUM MARIANUM SEED; SODIUM SULFATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-8148_014f77d7-a396-4e7d-a3d2-d9a949c08f6c 57955-8148 HUMAN OTC DRUG Anti Aging and Wrinkles For Women Abrotanum, Adrenalinum, Adrenocorticotrophin, Alpha-Ketoglutaricum acidum, Alpha-Lipoicum acidum, Baryta carbonica, Calcarea fluorica, Citricum acidum, Coenzyme A, DNA, Ferrum metallicum, Glandula suprarenalis suis, Hekla lava, Helleborus niger, Hypothalamus, Lycopodium clavatum, Oophorinum, RNA, Secale Cornutum, Silicea, Thiaminum hydrochloricum LIQUID ORAL 20130827 UNAPPROVED HOMEOPATHIC King Bio Inc. .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ANHYDROUS CITRIC ACID; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CARBONATE; BOS TAURUS HYPOTHALAMUS; CALCIUM FLUORIDE; CLAVICEPS PURPUREA SCLEROTIUM; COENZYME A; CORTICOTROPIN; EPINEPHRINE; HEKLA LAVA; HELLEBORUS NIGER ROOT; HERRING SPERM DNA; IRON; LYCOPODIUM CLAVATUM SPORE; SACCHAROMYCES CEREVISIAE RNA; SILICON DIOXIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; THIAMINE HYDROCHLORIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-8150_139f254f-aec9-4bfa-bfd8-90c44efeb4c1 57955-8150 HUMAN OTC DRUG Good Mood Enhancer Agrimonia eupatoria, flos, Anacardium orientale, Aurum metallicum, Avena sativa, Borago officinalis, Calcarea carbonica, Capsicum annuum, Carpinus betulus, flos, Cimicifuga racemosa, Cinchona officinalis, Hypericum perforatum, Ignatia amara, Kali bromatum, Larix decidua, flos, Natrum carbonicum, Natrum sulphuricum, Phosphoricum acidum, Phosphorus, Pulsatilla, Sepia, Sinapis arvensis, flos, Tabacum LIQUID ORAL 20131031 UNAPPROVED HOMEOPATHIC King Bio Inc. AGRIMONIA EUPATORIA FLOWER; AVENA SATIVA FLOWERING TOP; BLACK COHOSH; BORAGE; CAPSICUM; CARPINUS BETULUS FLOWERING TOP; CINCHONA OFFICINALIS BARK; GOLD; HYPERICUM PERFORATUM; LARIX DECIDUA FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM BROMIDE; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS IGNATII SEED; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-8195_e33b89f7-bdeb-41d1-825e-216c8d7544ef 57955-8195 HUMAN OTC DRUG Regional Allergies Desert U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Alfalfa, Allium cepa, Ambrosia artemisiaefolia, Cortisone aceticum, Erechtites hieracifolia, Erigeron canadensis, Euonymus atropurpureus, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Sabadilla, Stramonium and Triticum repens LIQUID ORAL 20130709 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; ALFALFA; AMBROSIA ARTEMISIIFOLIA; CONYZA CANADENSIS; CORTICOTROPIN; CORTISONE ACETATE; DATURA STRAMONIUM; ELYMUS REPENS ROOT; EPINEPHRINE; ERECHTITES HIERACIIFOLIUS; EUONYMUS ATROPURPUREUS BRANCH BARK/ROOT BARK; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; ONION; POTASSIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-8197_73c8e7eb-7d6f-40cf-b36b-73461d5ecca2 57955-8197 HUMAN OTC DRUG Regional Allergies Northeastern US Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Agraphis nutans, Allium cepa, Collinsonia canadensis, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Salvia officinalis, Tanacetum vulgare, Trifolium pratense, Vinca minor LIQUID ORAL 20130709 UNAPPROVED HOMEOPATHIC King Bio Inc, ADENOSINE CYCLIC PHOSPHATE; COLLINSONIA CANADENSIS ROOT; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; HYACINTHOIDES NON-SCRIPTA; ONION; POTASSIUM CHLORIDE; RUMEX CRISPUS ROOT; SACCHAROMYCES CEREVISIAE RNA; SAGE; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; TANACETUM VULGARE TOP; TRIFOLIUM PRATENSE FLOWER; VINCA MINOR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-8199_70cc49df-56e5-4d1f-89da-9d93973fe094 57955-8199 HUMAN OTC DRUG Regional Allergies Plains U.S. Absinthium, Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemisiaefolla, Caulophyllum thalictroides, Conium maculatum, Cortisone aceticum, Euphrasia officinalis, Fagopyrum esculentum, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Melilotus officinalis, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Secale cornutum LIQUID ORAL 20130924 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; AMBROSIA ARTEMISIIFOLIA; CAULOPHYLLUM THALICTROIDES ROOT; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; MELILOTUS OFFICINALIS TOP; ONION; POTASSIUM CHLORIDE; RUMEX CRISPUS ROOT; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; WORMWOOD 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-8200_d90a7be9-0931-4dff-a852-c17f75f92684 57955-8200 HUMAN OTC DRUG Regional Allergies Rocky Mtns. U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Agrimonia eupatoria, Agrostemma githago, Ailanthus glandulosus, Allium cepa, Cortisone aceticum, Cynodon dactylon, Equisetum hyemale, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Platanus, Populus candicans, RNA, Sabadilla, Solidago virgaurea LIQUID ORAL 20130812 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; AGRIMONIA EUPATORIA; AGROSTEMMA GITHAGO SEED; AILANTHUS ALTISSIMA FLOWERING TWIG; CORTICOTROPIN; CORTISONE ACETATE; CYNODON DACTYLON; EPINEPHRINE; EQUISETUM HYEMALE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; ONION; PLATANUS OCCIDENTALIS WHOLE; POPULUS BALSAMIFERA LEAF BUD; POTASSIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA NASAL MUCOSA 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-8201_dc4e2c6d-9b6e-4540-b6ca-288ec6c64bae 57955-8201 HUMAN OTC DRUG Regional Allergies Southern U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Alnus serrulata, Carduus benedictus, Cichorium intybus, Cortisone aceticum, Dolichos pruriens, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, juglans cinerea, Kali muriaticum, Mucosa nasalis suis, Nasturtium aquaticum, Natrum muriaticum, RNA, Rhus toxicodendron, Sabadilla, Sassafras officinale LIQUID ORAL 20130927 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; ALNUS SERRULATA BARK; CENTAUREA BENEDICTA; CHICORY ROOT; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; MUCUNA PRURIENS FRUIT TRICHOME; NASTURTIUM OFFICINALE; ONION; POTASSIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SASSAFRAS ALBIDUM ROOT BARK; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 57955-8300_59a27717-88eb-4b8e-b6de-bc80f14c2a68 57955-8300 HUMAN OTC DRUG Food Intolerances Aethusa cynapium, Calcarea carbonica, Cucurbita pepo, semen, Gambogia, Histaminum hydrochloricum, Hydrastis canadensis, Lycopodium clavatum, Natrum carbonicum, Nitricum acidum, Nux vomica, Ovi gallinae pellicula, Phosphorus, Pulsatilla, Sulphur LIQUID ORAL 20131104 UNAPPROVED HOMEOPATHIC King Bio Inc. AETHUSA CYNAPIUM; EGG SHELL MEMBRANE; GAMBOGE; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; PUMPKIN SEED; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-8310_63a50433-ae89-4dd1-87c7-0140f47858b2 57955-8310 HUMAN OTC DRUG Pet Hair and Dander Allergies Aralia racemosa, Arsenicum album, Histaminum hydrochloricum, Nux vomica, Oleum animale, Phosphorus, Silicea, Sulphur LIQUID ORAL 20131112 UNAPPROVED HOMEOPATHIC King Bio Inc. ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; CERVUS ELAPHUS HORN OIL; HISTAMINE DIHYDROCHLORIDE; PHOSPHORUS; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-8315_0d634610-703e-48c5-9356-8bdefe43ebd7 57955-8315 HUMAN OTC DRUG Midwest Regional Allergies Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemisiaefolia, Cichorium intybus, Conium maculatum, Cortisone aceticum, Euphrasia officinalis, Fagopyrum esculentum, Galphimia glauca, Hedera helix, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Secale cornutum LIQUID ORAL 20131104 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; AMBROSIA ARTEMISIIFOLIA; CHICORY ROOT; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; HISTAMINE DIHYDROCHLORIDE; ONION; POTASSIUM CHLORIDE; RUMEX CRISPUS ROOT; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-8325_6a68ab31-cef2-4779-a9ec-50830766b1e9 57955-8325 HUMAN OTC DRUG Northeast Regional Allergies Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Agraphis nutans, Allium cepa, Collinsonia canadensis, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Salvia officinalis, Tanacetum vulgare, Trifolium pratense, Vinca minor LIQUID ORAL 20131104 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; COLLINSONIA CANADENSIS ROOT; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; HYACINTHOIDES NON-SCRIPTA; ONION; POTASSIUM CHLORIDE; RUMEX CRISPUS ROOT; SACCHAROMYCES CEREVISIAE RNA; SAGE; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; TANACETUM VULGARE TOP; TRIFOLIUM PRATENSE FLOWER; VINCA MINOR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-8330_69496972-6b6f-46d0-9184-f98ac902489c 57955-8330 HUMAN OTC DRUG Pacific Regional Allergies Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Alfalfa, Allium cepa, Bellis perennis, Conium maculatum, Cortisone aceticum, Equisetum hyemale, Euphrasia officinalis, Fagopyrum esculentum, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Millefolium, Mucosa nasalis suis, Natrum muriaticum, Prunus spinosa, RNA, Sabadilla, Solidago virgaurea LIQUID ORAL 20131126 UNAPPROVED HOMEOPATHIC King Bio Inc. ACHILLEA MILLEFOLIUM; ADENOSINE CYCLIC PHOSPHATE; ALFALFA; BELLIS PERENNIS; CONIUM MACULATUM FLOWERING TOP; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EQUISETUM HYEMALE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; ONION; POTASSIUM CHLORIDE; PRUNUS SPINOSA FLOWER BUD; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA NASAL MUCOSA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-8345_bca09038-3e58-4194-8867-6c994b152ce5 57955-8345 HUMAN OTC DRUG Southeast Regional Allergies Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Alnus serrulata, Carduus benedictus, Cichorium intybus, Cortisone aceticum, Dolichos pruriens, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Mucosa nasalis suis, Nasturtium aquaticum, Natrum muriaticum, RNA, Rhus toxicodendron, Sabadilla, Sassafras officinale LIQUID ORAL 20131031 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; ALNUS SERRULATA BARK; CENTAUREA BENEDICTA; CHICORY ROOT; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; MUCUNA PRURIENS FRUIT TRICHOME; NASTURTIUM OFFICINALE; ONION; POTASSIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SASSAFRAS ALBIDUM ROOT BARK; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL 57955-8699_fefda55e-4ca9-4ae0-a9f1-3e36db41e251 57955-8699 HUMAN OTC DRUG Skin Tag Remover Thuja occidentalis LIQUID TOPICAL 20140108 UNAPPROVED HOMEOPATHIC King Bio Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/15mL 57957-0007_8bcf4ae2-a9cf-4e0b-9be2-f52361c956aa 57957-0007 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19760101 UNAPPROVED MEDICAL GAS Bernens Convalescent Pharmacy, Inc OXYGEN 99 L/100L 57962-140_d85e602d-8930-49ae-a49a-1c4959397ba6 57962-140 HUMAN PRESCRIPTION DRUG IMBRUVICA Ibrutinib CAPSULE ORAL 20131107 NDA NDA205552 Pharmacyclics, Inc IBRUTINIB 140 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 57970-100_705cd17c-b9d3-43c7-a961-7298995f1612 57970-100 HUMAN PRESCRIPTION DRUG DALVANCE Dalbavancin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140523 NDA NDA021883 Durata Therapeutics Inc. DALBAVANCIN HYDROCHLORIDE 500 mg/25mL 57993-001_eed677b6-a42f-45c6-acff-5ed5c64d0c9d 57993-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Sanford HealthCare Accessories, LLC OXYGEN 99 L/100L 58004-001_14e0493a-16da-457b-ac2a-9010677ba378 58004-001 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130427 OTC MONOGRAPH NOT FINAL part333A NATIONWIDE PROMOTIONS LLC ALCOHOL 62 mL/100mL 58004-002_b47ccf71-bfd1-4e5d-8ee4-91d996bbd4f7 58004-002 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol SPRAY TOPICAL 20130427 OTC MONOGRAPH NOT FINAL part333A NATIONWIDE PROMOTIONS LLC ALCOHOL 62 mL/100mL 58021-001_b810bbfb-8cce-42e2-bf2d-ce625c580f3a 58021-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100801 UNAPPROVED MEDICAL GAS Kern Medical Inc dba DASCO Home Medical Equipment OXYGEN 990 mL/L 58029-223_8dc6340b-dc85-499c-bc87-a188e1629133 58029-223 HUMAN OTC DRUG zinc oxide zinc oxide OINTMENT TOPICAL 20110201 OTC MONOGRAPH FINAL part347 Gerimedix Incorporated ZINC OXIDE 1.8 g/100g 58029-224_dd02a0d6-354e-405e-a60b-64410c9bd44d 58029-224 HUMAN OTC DRUG GeriGard zinc oxide OINTMENT TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Gerimedix Incorporated ZINC OXIDE 1.8 g/100g 58048-0001_f8774a15-6a12-4025-8487-e062e1396e4e 58048-0001 HUMAN OTC DRUG Lyme and Co-Infection Nosode Angelica Archangelica, Hydrastis Canadensis, Kali Muriaticum, Yucca Filamentosa, Cartilago Suis, Phytolacca Decandra, Rhus Toxicodendron LIQUID ORAL 20131004 UNAPPROVED HOMEOPATHIC BioPure Healing Products, LLC ANGELICA ARCHANGELICA ROOT; ANHYDROUS CITRIC ACID; ARNICA MONTANA; BABESIA MICROTI; BORRELIA BURGDORFERI; CAUSTICUM; CHLAMYDIA TRACHOMATIS; GOLDENSEAL; HUMAN HERPESVIRUS 5; JAPANESE ENCEPHALITIS VIRUS; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE; OXALIC ACID; PHYTOLACCA AMERICANA ROOT; POTASSIUM CHLORIDE; RICKETTSIA RICKETTSII; SUS SCROFA CARTILAGE; TOXICODENDRON PUBESCENS LEAF; YUCCA FILAMENTOSA 2; 6; 8; 12; 12; 6; 12; 3; 6; 12; 12; 30; 8; 8; 8; 3; 3; 8; 3; 6; 3 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 58060-002_39b323b1-0ce6-460f-8204-33eafb74a788 58060-002 HUMAN PRESCRIPTION DRUG Radiogardase Prussian blue insoluble capsules CAPSULE ORAL 20100324 NDA NDA021626 Heyl Chem.-pharm. Fabrik GmbH & Co. KG FERRIC FERROCYANIDE 500 mg/1 58069-010_7b51f02c-9e36-4469-97ac-c6baec73b6fe 58069-010 HUMAN OTC DRUG Version X Scalp Tonic Allantoin LIQUID TOPICAL 20130201 OTC MONOGRAPH FINAL part347 CHRISTLTD ALLANTOIN .625 mg/125mL 58088-001_c31e0961-9d66-45d9-bd5e-2b37d078c8e3 58088-001 HUMAN OTC DRUG Canova Immune Support Canova Immune Support LIQUID ORAL 20130506 UNAPPROVED HOMEOPATHIC MRL Homeopathic USA LLC ACONITUM NAPELLUS; APIS MELLIFERA; ARSENIC TRIOXIDE; ASAFETIDA; BARIUM CARBONATE; BRYONIA ALBA ROOT; CASTOR OIL; CONIUM MACULATUM FLOWERING TOP; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SILICON DIOXIDE; THUJA OCCIDENTALIS ROOT; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 20; 19; 17; 20; 20; 14; 14; 16; 13; 18; 20; 20; 13; 18; 16; 17; 20 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 58092-001_a47683ea-aa14-433c-bb8f-3aa808595645 58092-001 HUMAN OTC DRUG DrxNoze Nosebleed Relief Achillea Millefolium, Marrubium Vulgare, Stachys Betonica, Urtica Dioica SWAB NASAL 20140201 UNAPPROVED HOMEOPATHIC ByzMed, LLC ACHILLEA MILLEFOLIUM; MARRUBIUM VULGARE; STACHYS OFFICINALIS; URTICA DIOICA 1; 1; 1; 1 [hp_X]/1.5mL; [hp_X]/1.5mL; [hp_X]/1.5mL; [hp_X]/1.5mL 58095-0001_69e8c1b6-3577-4870-859c-37d29b39bc52 58095-0001 HUMAN OTC DRUG HGH PLUS Arnica Montana, Deer Antler Velvet, Hepar Bovine, HGH, IGF-1, Pituitaria Glandula Bovine, Thuja Occidentalis LIQUID ORAL 20131004 UNAPPROVED HOMEOPATHIC Solutions 4 Health ARNICA MONTANA; BEEF LIVER; BOS TAURUS PITUITARY GLAND; CERVUS NIPPON VELVET; MECASERMIN; SOMATROPIN; THUJA OCCIDENTALIS LEAF 6; 6; 5; 8; 8; 24; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 58111-105_d86dd15f-e94d-4cb7-ba39-b7e7a8865c15 58111-105 HUMAN OTC DRUG PrimaDerm Anti-dandruff Pyrithione Zinc SHAMPOO TOPICAL 20050801 OTC MONOGRAPH FINAL part358H Derma Sciences PYRITHIONE ZINC 1 mg/100mL 58118-0001_996d21df-00b1-4444-814a-521b57e5e06d 58118-0001 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 Clinical Solutions Wholesale METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 58118-0002_f2b67032-2ad0-4db5-a8b5-f1d3943f65d8 58118-0002 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19970917 ANDA ANDA074880 Clinical Solutions Wholesale ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 58118-0005_9fdc45ac-cdf4-470c-8ede-2fefaa7ad2f1 58118-0005 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Clinical Solutions Wholesale SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 58118-0006_9fdc45ac-cdf4-470c-8ede-2fefaa7ad2f1 58118-0006 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Clinical Solutions Wholesale SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 58118-0007_9fdc45ac-cdf4-470c-8ede-2fefaa7ad2f1 58118-0007 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Clinical Solutions Wholesale SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 58118-0009_64845ba1-a269-4d6d-9b4c-f843a1e615fa 58118-0009 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19961002 NDA NDA050720 Clinical Solutions Wholesale AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 58118-0010_8bcfa211-e988-4721-b5d5-d0ab15059370 58118-0010 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075961 Clinical Solutions Wholesale METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 58118-0011_f8a8c870-1424-49fd-b7c1-0f5694dece4d 58118-0011 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040787 Clinical Solutions Wholesale HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 58118-0012_f8a8c870-1424-49fd-b7c1-0f5694dece4d 58118-0012 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040788 Clinical Solutions Wholesale HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 58118-0013_5ec02768-5f9f-4009-9c5f-741be09209ba 58118-0013 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL 20091105 UNAPPROVED DRUG OTHER Clinical Solutions Wholesale HYOSCYAMINE SULFATE .375 mg/1 58118-0015_0e28741c-6c47-414f-b45c-5e88ced22264 58118-0015 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin POWDER, FOR SUSPENSION ORAL 19990415 NDA NDA050760 Clinical Solutions Wholesale AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 58118-0016_0e28741c-6c47-414f-b45c-5e88ced22264 58118-0016 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin POWDER, FOR SUSPENSION ORAL 19990415 NDA NDA050760 Clinical Solutions Wholesale AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 58118-0017_cd60e48c-c6ce-4b30-8f82-5d9a3e5c0f51 58118-0017 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050575 Clinical Solutions Wholesale AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 58118-0018_1fd52caf-6020-49ab-9555-139dbf5c48e6 58118-0018 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA087342 Clinical Solutions Wholesale PREDNISONE 20 mg/1 58118-0019_8f7c8be1-1f83-4e98-840d-5f1ad54cbab9 58118-0019 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20010622 NDA NDA050755 Clinical Solutions Wholesale AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 58118-0020_2c4b6512-0be3-4e5d-8aa6-1809f8027352 58118-0020 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20101217 ANDA ANDA065246 Clinical Solutions Wholesale AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 58118-0028_266c4331-1450-4f36-be43-db3f4eaa7c57 58118-0028 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20080116 ANDA ANDA077570 Clinical Solutions Wholesale FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 58118-0031_691bf68b-9fc8-41d8-b0b7-a41826a718b3 58118-0031 HUMAN PRESCRIPTION DRUG mometasone furoate Mometasone Furoate CREAM TOPICAL 20051128 ANDA ANDA076679 Clinical Solutions Wholesale MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 58118-0036_627d4440-8b9b-490f-bb05-e3c9daf60476 58118-0036 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 Clinical Solutions Wholesale TRIAMCINOLONE ACETONIDE 1 mg/g 58118-0037_e4a92e7c-6d19-45e7-91f0-685f68383784 58118-0037 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 Clinical Solutions Wholesale ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 58118-0038_f6421848-56d7-43a2-b05a-5155b692be6c 58118-0038 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 Clinical Solutions Wholesale AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 58118-0039_8e504fb4-4de9-431e-b0a5-6d78279ae99e 58118-0039 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin TABLET, FILM COATED ORAL 19780710 NDA NDA050754 Clinical Solutions Wholesale AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 58118-0047_cd60e48c-c6ce-4b30-8f82-5d9a3e5c0f51 58118-0047 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050575 Clinical Solutions Wholesale AMOXICILLIN; CLAVULANATE POTASSIUM 250; 62.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 58118-0057_cd60e48c-c6ce-4b30-8f82-5d9a3e5c0f51 58118-0057 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050575 Clinical Solutions Wholesale AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 58118-0066_31a0c06d-6cc2-4f77-909c-9cfc22ed600b 58118-0066 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080936 Clinical Solutions Wholesale ISONIAZID 100 mg/1 Antimycobacterial [EPC] 58118-0071_31a0c06d-6cc2-4f77-909c-9cfc22ed600b 58118-0071 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080937 Clinical Solutions Wholesale ISONIAZID 300 mg/1 Antimycobacterial [EPC] 58118-0079_2b52d057-2774-439f-962e-79a56d0579aa 58118-0079 HUMAN PRESCRIPTION DRUG Balsalazide Disodium Balsalazide Disodium CAPSULE ORAL 20071228 ANDA ANDA077806 Clinical Solutions Wholesale BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 58118-0101_0a12003c-1972-4606-aa82-ab09ad3992df 58118-0101 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Clinical Solutions Wholesale GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 58118-0102_ac6b1627-c878-47ac-bea8-9437cc4f545f 58118-0102 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Clinical Solutions Wholesale METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 58118-0105_65e31047-c6ac-4d6e-8bbd-a7652f939bc9 58118-0105 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Clinical Solutions Wholesale BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 58118-0106_65e31047-c6ac-4d6e-8bbd-a7652f939bc9 58118-0106 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 Clinical Solutions Wholesale BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 58118-0107_48a05bb4-084a-41d0-8872-9b7ff7ce3a6c 58118-0107 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20090127 ANDA ANDA040863 Clinical Solutions Wholesale PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 58118-0113_1d9036f1-fba4-4d1f-898b-8b06ff7ea5b3 58118-0113 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Clinical Solutions Wholesale LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 58118-0114_1d9036f1-fba4-4d1f-898b-8b06ff7ea5b3 58118-0114 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Clinical Solutions Wholesale LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 58118-0115_322e677f-a6cb-47d6-a22c-888c940433e0 58118-0115 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Clinical Solutions Wholesale LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 58118-0121_465578dc-f4e0-4061-a029-8b2353da771f 58118-0121 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride TABLET ORAL 20100604 ANDA ANDA040659 Clinical Solutions Wholesale MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 58118-0124_976084ce-686e-4a82-b231-4ed0f6d12541 58118-0124 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Clinical Solutions Wholesale MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-0125_976084ce-686e-4a82-b231-4ed0f6d12541 58118-0125 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Clinical Solutions Wholesale MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-0127_6c5ae0bb-3295-4ec0-bed3-f645bd41daaf 58118-0127 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Clinical Solutions Wholesale CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 58118-0128_f7fd2d29-0b72-4801-a91e-ed55c1ac083f 58118-0128 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide TABLET ORAL 20100315 ANDA ANDA090510 Clinical Solutions Wholesale HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 58118-0129_f7fd2d29-0b72-4801-a91e-ed55c1ac083f 58118-0129 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide TABLET ORAL 20100315 ANDA ANDA090510 Clinical Solutions Wholesale HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 58118-0130_f7fd2d29-0b72-4801-a91e-ed55c1ac083f 58118-0130 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20100315 ANDA ANDA090510 Clinical Solutions Wholesale HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 58118-0155_5df2c59c-9ee4-4aed-bc69-026412985ded 58118-0155 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 Clinical Solutions Wholesale PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-0156_5df2c59c-9ee4-4aed-bc69-026412985ded 58118-0156 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 Clinical Solutions Wholesale PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-0157_fef57386-4307-452b-884b-2b4401d042a8 58118-0157 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20100723 ANDA ANDA091004 Clinical Solutions Wholesale ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 58118-0158_87d35119-bc1c-418a-b2e4-7ea4010236e6 58118-0158 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Clinical Solutions Wholesale OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 58118-0159_87d35119-bc1c-418a-b2e4-7ea4010236e6 58118-0159 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Clinical Solutions Wholesale OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 58118-0162_7cb2b7c9-7368-4b65-896f-8d6cb10c79ff 58118-0162 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Clinical Solutions Wholesale CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 58118-0163_7cb2b7c9-7368-4b65-896f-8d6cb10c79ff 58118-0163 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Clinical Solutions Wholesale CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 58118-0164_7cb2b7c9-7368-4b65-896f-8d6cb10c79ff 58118-0164 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Clinical Solutions Wholesale CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 58118-0165_7cb2b7c9-7368-4b65-896f-8d6cb10c79ff 58118-0165 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Clinical Solutions Wholesale CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 58118-0167_a59a4243-8905-4aba-af5f-5530630ce4cd 58118-0167 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Clinical Solutions Wholesale METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 58118-0168_ec1423be-4c6c-4974-993d-106211deb788 58118-0168 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Clinical Solutions Wholesale PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 58118-0169_ec1423be-4c6c-4974-993d-106211deb788 58118-0169 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Clinical Solutions Wholesale PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 58118-0170_8b7ecf6b-adf0-4a3b-9161-87649d7a8e29 58118-0170 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20010131 ANDA ANDA075855 Clinical Solutions Wholesale OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-0178_e88080dd-7cdf-44a8-9f09-8c844cda8c7f 58118-0178 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091202 ANDA ANDA078596 Clinical Solutions Wholesale METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 58118-0179_449b1b6a-fdf5-4e29-b0a3-a962dbcdf843 58118-0179 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Clinical Solutions Wholesale TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 58118-0180_1843fe38-ca84-4165-9d07-1a6d50eb1d46 58118-0180 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride TABLET ORAL 20020627 ANDA ANDA076280 Clinical Solutions Wholesale TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 58118-0189_4773d407-0679-4019-9e24-da1b1cfae8ed 58118-0189 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Clinical Solutions Wholesale NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-0190_4773d407-0679-4019-9e24-da1b1cfae8ed 58118-0190 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Clinical Solutions Wholesale NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-0194_4773d407-0679-4019-9e24-da1b1cfae8ed 58118-0194 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Clinical Solutions Wholesale NAPROXEN 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-0201_813d3b17-543f-48b7-bdcc-b9c6bccda9ce 58118-0201 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20101231 ANDA ANDA090066 Clinical Solutions Wholesale DICLOFENAC SODIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-0202_488d906f-015d-4704-931f-246c24987128 58118-0202 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET, FILM COATED ORAL 20060824 ANDA ANDA077525 Clinical Solutions Wholesale GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 58118-0204_488d906f-015d-4704-931f-246c24987128 58118-0204 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET, FILM COATED ORAL 20060824 ANDA ANDA077525 Clinical Solutions Wholesale GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 58118-0211_31d6d562-7da4-4a6e-8fcb-47f4094d4f14 58118-0211 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20080311 ANDA ANDA065470 Clinical Solutions Wholesale MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 58118-0212_813d3b17-543f-48b7-bdcc-b9c6bccda9ce 58118-0212 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20101231 ANDA ANDA090066 Clinical Solutions Wholesale DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-0213_80729f66-7d69-464f-b2e0-ac7fd93baa48 58118-0213 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Clinical Solutions Wholesale SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-0214_80729f66-7d69-464f-b2e0-ac7fd93baa48 58118-0214 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Clinical Solutions Wholesale SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-0223_1c6371e5-3960-41cb-b884-10757cc52d05 58118-0223 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Clinical Solutions Wholesale GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 58118-0224_1c6371e5-3960-41cb-b884-10757cc52d05 58118-0224 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Clinical Solutions Wholesale GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 58118-0238_770b0df7-e41f-4374-9494-55af0e9c0520 58118-0238 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Clinical Solutions Wholesale AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 58118-0239_770b0df7-e41f-4374-9494-55af0e9c0520 58118-0239 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Clinical Solutions Wholesale AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 58118-0240_6d497b23-a6c5-4a78-9671-403a84d9f0bb 58118-0240 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Clinical Solutions Wholesale ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 58118-0248_42884d6a-ed7c-431a-be91-766dd40bde33 58118-0248 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Clinical Solutions Wholesale RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 58118-0249_d9d9f86b-5afe-4c66-9fbb-c8b9c48a8f78 58118-0249 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Clinical Solutions Wholesale RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 58118-0253_b83496fb-91ef-446b-b7ab-7eb8f8da45a5 58118-0253 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Clinical Solutions Wholesale RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 58118-0260_6db3fe44-8ef5-4742-afdd-7f55e795f51e 58118-0260 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Clinical Solutions Wholesale NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 58118-0261_6db3fe44-8ef5-4742-afdd-7f55e795f51e 58118-0261 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Clinical Solutions Wholesale NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 58118-0262_6db3fe44-8ef5-4742-afdd-7f55e795f51e 58118-0262 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Clinical Solutions Wholesale NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 58118-0268_e36ece79-544b-43b2-8cf9-ca9861b071b5 58118-0268 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20091023 ANDA ANDA077272 Clinical Solutions Wholesale CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 58118-0277_963792a9-4029-4e7b-9759-9ad52e1b0962 58118-0277 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20061016 NDA NDA021995 Clinical Solutions Wholesale SITAGLIPTIN PHOSPHATE 100 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] 58118-0293_2e6a5a7b-2045-45f4-955f-12531d9d65bc 58118-0293 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA090700 Clinical Solutions Wholesale VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 58118-0301_2f7d7199-e3f9-489b-9255-782d99d77e9f 58118-0301 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084112 Clinical Solutions Wholesale CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 58118-0302_2f7d7199-e3f9-489b-9255-782d99d77e9f 58118-0302 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084113 Clinical Solutions Wholesale CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 58118-0303_ced4d70a-0548-4ee3-a80a-374d0c4b87d8 58118-0303 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 Clinical Solutions Wholesale NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 58118-0304_2f7d7199-e3f9-489b-9255-782d99d77e9f 58118-0304 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084115 Clinical Solutions Wholesale CHLORPROMAZINE HYDROCHLORIDE 200 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 58118-0311_360931e0-7ffe-4f8c-972d-43d188041a85 58118-0311 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA073192 Clinical Solutions Wholesale LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 58118-0314_272e9b1e-5a31-489c-99a0-ae76fac14aae 58118-0314 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 19980617 ANDA ANDA074754 Clinical Solutions Wholesale KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-0321_f0e8fb88-93a1-4994-8b6b-0336bb11b36d 58118-0321 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Clinical Solutions Wholesale GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 58118-0322_f0e8fb88-93a1-4994-8b6b-0336bb11b36d 58118-0322 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Clinical Solutions Wholesale GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 58118-0341_4099f945-94ad-40c6-beff-45cd02d96bb0 58118-0341 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Clinical Solutions Wholesale HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 58118-0342_4099f945-94ad-40c6-beff-45cd02d96bb0 58118-0342 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Clinical Solutions Wholesale HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 58118-0343_4099f945-94ad-40c6-beff-45cd02d96bb0 58118-0343 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Clinical Solutions Wholesale HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 58118-0344_4099f945-94ad-40c6-beff-45cd02d96bb0 58118-0344 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Clinical Solutions Wholesale HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 58118-0345_89dcb53f-080c-409a-ba85-ec0271be7653 58118-0345 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070994 Clinical Solutions Wholesale VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 58118-0351_7c4a95b7-1ed1-42c0-a1d6-e2f26807c327 58118-0351 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Clinical Solutions Wholesale SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-0352_22ce8faf-6b90-4285-abf5-3358bb7fe21b 58118-0352 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Clinical Solutions Wholesale SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-0353_22ce8faf-6b90-4285-abf5-3358bb7fe21b 58118-0353 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Clinical Solutions Wholesale SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-0356_6d497b23-a6c5-4a78-9671-403a84d9f0bb 58118-0356 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Clinical Solutions Wholesale ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 58118-0357_7c96b52e-99c9-4b70-b467-3d00bbc58acf 58118-0357 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA090540 Clinical Solutions Wholesale CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 58118-0358_b2ab77f7-4637-4977-8b4b-02ea01fee183 58118-0358 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20110613 ANDA ANDA091083 Clinical Solutions Wholesale NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-0369_42f33d10-2c5f-4c73-b964-ef3c09d627ae 58118-0369 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 19880615 ANDA ANDA072204 Clinical Solutions Wholesale LOXAPINE SUCCINATE 5 mg/1 58118-0370_42f33d10-2c5f-4c73-b964-ef3c09d627ae 58118-0370 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 19880615 ANDA ANDA072205 Clinical Solutions Wholesale LOXAPINE SUCCINATE 10 mg/1 58118-0371_42f33d10-2c5f-4c73-b964-ef3c09d627ae 58118-0371 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 19880615 ANDA ANDA072206 Clinical Solutions Wholesale LOXAPINE SUCCINATE 25 mg/1 58118-0372_42f33d10-2c5f-4c73-b964-ef3c09d627ae 58118-0372 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 19880615 ANDA ANDA072062 Clinical Solutions Wholesale LOXAPINE SUCCINATE 50 mg/1 58118-0387_9b0610d1-518e-4682-b645-e16d4ebada7a 58118-0387 HUMAN OTC DRUG aspirin low dose enteric coated aspirin TABLET, COATED ORAL 20100628 OTC MONOGRAPH FINAL part343 Clinical Solutions Wholesale ASPIRIN 81 mg/1 58118-0402_a102cc90-d46b-48a1-9bd6-4a90477bfc07 58118-0402 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Clinical Solutions Wholesale CETIRIZINE HYDROCHLORIDE 10 mg/1 58118-0404_6a1e66af-d922-4aa1-bd4c-08168bb26563 58118-0404 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20110818 ANDA ANDA091211 Clinical Solutions Wholesale ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 58118-0405_ee7fa59c-1c07-4b89-92f0-cd7f2a765c5b 58118-0405 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20070802 NDA AUTHORIZED GENERIC NDA019962 Clinical Solutions Wholesale METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 58118-0409_322e677f-a6cb-47d6-a22c-888c940433e0 58118-0409 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Clinical Solutions Wholesale LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 58118-0411_3810fd72-3563-4967-b432-49d7e6f5330d 58118-0411 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Clinical Solutions Wholesale CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 58118-0420_2883642b-a1d6-474a-9750-f699694bb010 58118-0420 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Clinical Solutions Wholesale SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 58118-0433_6d783fcf-6010-4c3f-bca5-1b33ea945d77 58118-0433 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 Clinical Solutions Wholesale TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 58118-0434_6d783fcf-6010-4c3f-bca5-1b33ea945d77 58118-0434 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071524 Clinical Solutions Wholesale TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 58118-0435_d9f97275-a046-4af3-83d0-a7a18acc97f2 58118-0435 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 Clinical Solutions Wholesale METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 58118-0441_6d783fcf-6010-4c3f-bca5-1b33ea945d77 58118-0441 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071525 Clinical Solutions Wholesale TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 58118-0458_a3a31433-1edf-42b6-8617-f6b235172065 58118-0458 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Clinical Solutions Wholesale ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 58118-0459_292f2650-c9fc-4490-a734-6ef76598ff8c 58118-0459 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19900930 ANDA ANDA089763 Clinical Solutions Wholesale THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 58118-0461_6f2f77a7-f719-477f-8b66-34e728198182 58118-0461 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Clinical Solutions Wholesale GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 58118-0464_ac8d5dad-9921-4ed0-9098-c8cbc663b32a 58118-0464 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Clinical Solutions Wholesale IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-0465_ac8d5dad-9921-4ed0-9098-c8cbc663b32a 58118-0465 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Clinical Solutions Wholesale IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-0466_6fc2cc90-31a8-4d5b-ad8c-632b961d3a16 58118-0466 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Clinical Solutions Wholesale IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-0477_a59a4243-8905-4aba-af5f-5530630ce4cd 58118-0477 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Clinical Solutions Wholesale METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 58118-0478_c26fdd46-7553-4545-9db3-60b18540e72e 58118-0478 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20070601 ANDA ANDA078103 Clinical Solutions Wholesale SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 58118-0480_a206886a-907c-4ba1-a153-521730049466 58118-0480 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Clinical Solutions Wholesale ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 58118-0506_a59a4243-8905-4aba-af5f-5530630ce4cd 58118-0506 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Clinical Solutions Wholesale METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 58118-0507_802f6858-55a7-41eb-ab2f-4a03a6d00c03 58118-0507 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20041112 ANDA ANDA077032 Clinical Solutions Wholesale CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-0508_802f6858-55a7-41eb-ab2f-4a03a6d00c03 58118-0508 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20041112 ANDA ANDA077032 Clinical Solutions Wholesale CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-0512_3c5306df-bb73-4b5f-8876-c34cb35e8479 58118-0512 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Clinical Solutions Wholesale LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 58118-0513_3c5306df-bb73-4b5f-8876-c34cb35e8479 58118-0513 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Clinical Solutions Wholesale LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 58118-0514_3c5306df-bb73-4b5f-8876-c34cb35e8479 58118-0514 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Clinical Solutions Wholesale LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 58118-0515_3c5306df-bb73-4b5f-8876-c34cb35e8479 58118-0515 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Clinical Solutions Wholesale LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 58118-0516_128edbc7-d016-4b3e-b00d-9b20e3ce9400 58118-0516 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20101007 ANDA ANDA078938 Clinical Solutions Wholesale TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 58118-0517_3c5306df-bb73-4b5f-8876-c34cb35e8479 58118-0517 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Clinical Solutions Wholesale LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 58118-0518_4b2a365a-fe5b-4549-9940-aaf43f6ab9d3 58118-0518 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Clinical Solutions Wholesale PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 58118-0519_00c3be4a-c9a4-4ad8-8b0b-431098943256 58118-0519 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060410 ANDA ANDA077912 Clinical Solutions Wholesale HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 58118-0520_585027af-779a-440d-9b87-09dec474a792 58118-0520 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Clinical Solutions Wholesale PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 58118-0526_e1420f6f-8c08-4c4d-b44d-2d01f96ee123 58118-0526 HUMAN PRESCRIPTION DRUG Loratadine Allergy Relief Loratadine TABLET ORAL 20030828 ANDA ANDA076134 Clinical Solutions Wholesale LORATADINE 10 mg/1 58118-0541_e496ff89-97f6-4088-8ade-02159b4d97bb 58118-0541 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100218 ANDA ANDA078218 Clinical Solutions Wholesale CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 58118-0545_3ec62ecc-677d-4f61-88a3-1bd9d9108fd5 58118-0545 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 Clinical Solutions Wholesale LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 58118-0553_3877b27f-43c4-4258-a6a5-8edcc10219c3 58118-0553 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20130531 ANDA ANDA203399 Clinical Solutions Wholesale METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 58118-0570_83436456-d234-417b-b500-a8756ce51cc1 58118-0570 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110208 ANDA ANDA090797 Clinical Solutions Wholesale PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 58118-0571_62cdab2a-21ee-4330-8cb4-f5d9e3247d22 58118-0571 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110422 ANDA ANDA076447 Clinical Solutions Wholesale FEXOFENADINE HYDROCHLORIDE 180 mg/1 58118-0613_e3db41a6-b00e-4406-9e91-d840dd23c93c 58118-0613 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA087479 Clinical Solutions Wholsesale HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 58118-0615_e3db41a6-b00e-4406-9e91-d840dd23c93c 58118-0615 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA086183 Clinical Solutions Wholsesale HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 58118-0621_d2e861e8-c920-4e43-990c-5f7171972a82 58118-0621 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Clinical Solutions Wholesale ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 58118-0622_d2e861e8-c920-4e43-990c-5f7171972a82 58118-0622 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Clinical Solutions Wholesale ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 58118-0623_d2e861e8-c920-4e43-990c-5f7171972a82 58118-0623 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Clinical Solutions Wholesale ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 58118-0632_639a8253-1a97-445a-b1a7-8c2ca3434e70 58118-0632 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine CAPSULE ORAL 20050720 ANDA ANDA076990 Clinical Solutions Wholesale FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-0647_ecebc51e-c2ef-4210-83e8-cf26f42319ba 58118-0647 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Clinical Solutions Wholesale FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-0648_ecebc51e-c2ef-4210-83e8-cf26f42319ba 58118-0648 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Clinical Solutions Wholesale FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-0651_5072d6d2-2fc1-4d53-92e7-23f588ef5b33 58118-0651 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 20100129 NDA NDA006188 Clinical Solutions Wholesale PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 58118-0657_721f96e2-5def-499a-833c-51162854252f 58118-0657 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Clinical Solutions Wholesale BUSPIRONE HYDROCHLORIDE 10 mg/1 58118-0658_721f96e2-5def-499a-833c-51162854252f 58118-0658 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Clinical Solutions Wholesale BUSPIRONE HYDROCHLORIDE 5 mg/1 58118-0684_2280a305-34bd-4f9c-8f31-d6bb6fad90d5 58118-0684 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20071017 NDA NDA022122 Clinical Solutions Wholesale DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-0692_6cbe82a1-615e-42ff-b298-817476cdb151 58118-0692 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Clinical Solutions Wholesale CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 58118-0693_6cbe82a1-615e-42ff-b298-817476cdb151 58118-0693 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Clinical Solutions Wholesale CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 58118-0707_e8f46fff-a66d-4f29-bad4-b84ca1854f24 58118-0707 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Clinical Solutions Wholesale TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 58118-0710_e8f46fff-a66d-4f29-bad4-b84ca1854f24 58118-0710 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Clinical Solutions Wholesale TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 58118-0711_e8f46fff-a66d-4f29-bad4-b84ca1854f24 58118-0711 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Clinical Solutions Wholesale TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 58118-0712_e8f46fff-a66d-4f29-bad4-b84ca1854f24 58118-0712 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Clinical Solutions Wholesale TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 58118-0734_49f9eaf7-f737-4f6e-b55a-5579764312d7 58118-0734 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Clinical Solutions Wholesale METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 58118-0736_49f9eaf7-f737-4f6e-b55a-5579764312d7 58118-0736 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Clinical Solutions Wholesale METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 58118-0795_722618c7-c65c-47ec-8f1c-16863820ee61 58118-0795 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19860730 ANDA ANDA085223 Clinical Solutions Wholesale DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 58118-0797_2ca16cbf-cb95-409d-9e56-8034f9400f09 58118-0797 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 Clinical Solutions Wholesale DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 58118-0798_2ca16cbf-cb95-409d-9e56-8034f9400f09 58118-0798 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 Clinical Solutions Wholesale DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 58118-0810_1b2004cc-a5d0-4220-b0ae-0ef9e0fc8047 58118-0810 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Clinical Solutions Wholesale NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 58118-0811_1b2004cc-a5d0-4220-b0ae-0ef9e0fc8047 58118-0811 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950406 ANDA ANDA074132 Clinical Solutions Wholesale NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 58118-0813_c44bf87d-c175-46b9-a601-a608ca6bfc9b 58118-0813 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Clinical Solutions Wholesale NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 58118-0902_56eaafad-52a5-4295-85fc-b59d63819ca3 58118-0902 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Clinical Solutions Wholesale QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 58118-0903_56eaafad-52a5-4295-85fc-b59d63819ca3 58118-0903 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Clinical Solutions Wholesale QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 58118-0905_56eaafad-52a5-4295-85fc-b59d63819ca3 58118-0905 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Clinical Solutions Wholesale QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 58118-0906_56eaafad-52a5-4295-85fc-b59d63819ca3 58118-0906 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Clinical Solutions Wholesale QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 58118-0907_56eaafad-52a5-4295-85fc-b59d63819ca3 58118-0907 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Clinical Solutions Wholesale QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 58118-0921_6ec17924-9107-4ef9-bfbd-b865e3091ed9 58118-0921 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 Clinical Solutions Wholesale CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 58118-0922_6ec17924-9107-4ef9-bfbd-b865e3091ed9 58118-0922 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 Clinical Solutions Wholesale CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 58118-0999_1372953d-67e8-477d-a2f2-087a4122f061 58118-0999 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20040818 ANDA ANDA076368 Clinical Solutions Wholesale POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 58118-1024_ec18297f-a9c2-4d11-b27c-e1b658f6da5b 58118-1024 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20101020 ANDA ANDA074584 Clinical Solutions Wholesale BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 58118-1025_ec18297f-a9c2-4d11-b27c-e1b658f6da5b 58118-1025 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20101020 ANDA ANDA074584 Clinical Solutions Wholesale BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 58118-1045_f2a67587-08a8-498b-b0e7-36aaf40dd508 58118-1045 HUMAN PRESCRIPTION DRUG PNV Prenatal Plus Multivitamin VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, and CUPRIC OXIDE TABLET ORAL 20130401 UNAPPROVED DRUG OTHER Clinical Solutions Wholesale .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE 22; 2000; 120; 200; 400; 2; 12; 27; 1; 20; 10; 3; 1.84; 2000; 25 mg/1; [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 58118-1053_88f980a1-a2a2-4e8c-8208-70a17671bf21 58118-1053 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Clinical Solutions Wholesale BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 58118-1064_88f980a1-a2a2-4e8c-8208-70a17671bf21 58118-1064 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Clinical Solutions Wholesale BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 58118-1115_1d9036f1-fba4-4d1f-898b-8b06ff7ea5b3 58118-1115 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA090025 Clinical Solutions Wholesale LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 58118-1116_d6a1f8a0-e61a-465b-a890-7cb6dece39cc 58118-1116 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20090101 ANDA ANDA077031 Clinical Solutions Wholesale CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-1117_0c60eb51-784b-4ad1-8576-0fafbdd31ae4 58118-1117 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076312 Clinical Solutions Wholesale MIRTAZAPINE 15 mg/1 58118-1157_5df2c59c-9ee4-4aed-bc69-026412985ded 58118-1157 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 Clinical Solutions Wholesale PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-1170_ec1423be-4c6c-4974-993d-106211deb788 58118-1170 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Clinical Solutions Wholesale PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 58118-1248_93face50-9365-4db9-a29d-fef972d57cfb 58118-1248 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Clinical Solutions Wholesale MIRTAZAPINE 30 mg/1 58118-1249_93face50-9365-4db9-a29d-fef972d57cfb 58118-1249 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Clinical Solutions Wholesale MIRTAZAPINE 45 mg/1 58118-1254_f5b58cba-368b-4d32-8aa3-fabed2b26072 58118-1254 HUMAN OTC DRUG ED A-HIST CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20111008 OTC MONOGRAPH FINAL part341 Clinical Solutions Wholesale CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 58118-1260_2e6a5a7b-2045-45f4-955f-12531d9d65bc 58118-1260 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090917 ANDA ANDA078906 Clinical Solutions Wholesale VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 58118-1271_e36ece79-544b-43b2-8cf9-ca9861b071b5 58118-1271 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET, CHEWABLE ORAL 20090826 ANDA ANDA075712 Clinical Solutions Wholesale CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 58118-1290_56bb5a6e-d56e-4be6-b834-42f7f03b8525 58118-1290 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Clinical Solutions Wholesale METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 58118-1303_2f7d7199-e3f9-489b-9255-782d99d77e9f 58118-1303 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084114 Clinical Solutions Wholesale CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 58118-1323_ec1423be-4c6c-4974-993d-106211deb788 58118-1323 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Clinical Solutions Wholesale PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 58118-1341_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1341 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 58118-1342_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1342 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 58118-1343_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1343 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 58118-1344_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1344 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 58118-1345_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1345 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 58118-1346_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1346 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 58118-1347_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1347 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 58118-1349_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1349 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 58118-1351_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1351 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 58118-1391_3eff4808-7395-4265-93f0-576ac0bb9658 58118-1391 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071206 Clinical Solutions Wholesale HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] 58118-1392_3eff4808-7395-4265-93f0-576ac0bb9658 58118-1392 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071207 Clinical Solutions Wholesale HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] 58118-1393_3eff4808-7395-4265-93f0-576ac0bb9658 58118-1393 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071208 Clinical Solutions Wholesale HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] 58118-1396_3eff4808-7395-4265-93f0-576ac0bb9658 58118-1396 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071209 Clinical Solutions Wholesale HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 58118-1397_3eff4808-7395-4265-93f0-576ac0bb9658 58118-1397 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19880311 ANDA ANDA071210 Clinical Solutions Wholesale HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] 58118-1402_ba9b5739-39f8-4327-9316-fb239f784f44 58118-1402 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20061212 ANDA ANDA040621 Clinical Solutions Wholesale PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 58118-1404_89dcb53f-080c-409a-ba85-ec0271be7653 58118-1404 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19930629 ANDA ANDA072924 Clinical Solutions Wholesale VERAPAMIL HYDROCHLORIDE 40 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 58118-1436_bd9c7abe-ad50-4409-b841-e60b1ee5e915 58118-1436 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19871016 ANDA ANDA089586 Clinical Solutions Wholesale FLUPHENAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 58118-1437_bd9c7abe-ad50-4409-b841-e60b1ee5e915 58118-1437 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19871016 ANDA ANDA089586 Clinical Solutions Wholesale FLUPHENAZINE HYDROCHLORIDE 2.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 58118-1438_bd9c7abe-ad50-4409-b841-e60b1ee5e915 58118-1438 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19871016 ANDA ANDA089586 Clinical Solutions Wholesale FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 58118-1439_bd9c7abe-ad50-4409-b841-e60b1ee5e915 58118-1439 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19871016 ANDA ANDA089586 Clinical Solutions Wholesale FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 58118-1452_da64fdf6-7f9f-46f9-817b-dee8bfccdfc4 58118-1452 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Clinical Solutions Wholesale GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 58118-1459_a3a31433-1edf-42b6-8617-f6b235172065 58118-1459 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Clinical Solutions Wholesale ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 58118-1512_3476ec4d-4ac3-426f-8259-aa33c353afeb 58118-1512 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20100924 UNAPPROVED DRUG OTHER Clinical Solutions Wholesale SALSALATE 500 mg/1 58118-1513_3476ec4d-4ac3-426f-8259-aa33c353afeb 58118-1513 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20100924 UNAPPROVED DRUG OTHER Clinical Solutions Wholesale SALSALATE 750 mg/1 58118-1516_850b5b94-05a7-468c-8b90-77a1d45cd5c1 58118-1516 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Clinical Solutions Wholesale POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 58118-1518_00c3be4a-c9a4-4ad8-8b0b-431098943256 58118-1518 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060410 ANDA ANDA077912 Clinical Solutions Wholesale HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 58118-1520_00c3be4a-c9a4-4ad8-8b0b-431098943256 58118-1520 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060410 ANDA ANDA077912 Clinical Solutions Wholesale HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 58118-1525_fc274ebf-cce1-46d0-9137-1e579f5cb4c6 58118-1525 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 19981002 NDA NDA020998 Clinical Solutions Wholesale CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-1526_850b5b94-05a7-468c-8b90-77a1d45cd5c1 58118-1526 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Clinical Solutions Wholesale POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 58118-1638_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1638 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 58118-1812_c44bf87d-c175-46b9-a601-a608ca6bfc9b 58118-1812 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Clinical Solutions Wholesale NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 58118-1893_c24e6044-2509-4230-a6ef-53e9239831c6 58118-1893 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20090909 ANDA ANDA075009 Clinical Solutions Wholesale ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-1904_56eaafad-52a5-4295-85fc-b59d63819ca3 58118-1904 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Clinical Solutions Wholesale QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 58118-1962_449f3055-e47c-4305-aaf4-6b34aa74cc7c 58118-1962 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20050825 ANDA ANDA065136 Clinical Solutions Wholesale CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 58118-2013_2485d58a-33c9-4c0b-9d89-a96bbdab664d 58118-2013 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH FINAL part343 Clinical Solutions Wholesale ASPIRIN 325 mg/1 58118-2081_27f3f18d-375c-438b-9a24-15792975f261 58118-2081 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20120314 NDA AUTHORIZED GENERIC NDA021160 Clinical Solutions Wholesale CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 58118-2108_eacca660-72a6-4a47-b282-a50d9fcc521a 58118-2108 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Clinical Solutions Wholesale AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 58118-2115_cbf0ac4e-44be-40ae-a46a-935db8a24d57 58118-2115 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Clinical Solutions Wholesale ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 58118-2116_cbf0ac4e-44be-40ae-a46a-935db8a24d57 58118-2116 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Clinical Solutions Wholesale ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 58118-2212_7c41268a-8f57-4a8c-bae5-76ce29dee818 58118-2212 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Clinical Solutions Wholesale AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 58118-2213_7c41268a-8f57-4a8c-bae5-76ce29dee818 58118-2213 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Clinical Solutions Wholesale AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 58118-2214_a8a336a9-d226-40b8-96bc-41e74385e77a 58118-2214 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Clinical Solutions Wholesale AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 58118-2271_01f33db2-3be3-4765-963a-362da17c1d77 58118-2271 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Clinical Solutions Wholesale AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 58118-2272_01f33db2-3be3-4765-963a-362da17c1d77 58118-2272 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Clinical Solutions Wholesale AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 58118-2273_01f33db2-3be3-4765-963a-362da17c1d77 58118-2273 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Clinical Solutions Wholesale AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 58118-2274_01f33db2-3be3-4765-963a-362da17c1d77 58118-2274 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Clinical Solutions Wholesale AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 58118-2277_01f33db2-3be3-4765-963a-362da17c1d77 58118-2277 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Clinical Solutions Wholesale AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 58118-2279_01f33db2-3be3-4765-963a-362da17c1d77 58118-2279 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Clinical Solutions Wholesale AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 58118-2331_1ee59e1b-3d6f-4c36-b7a4-a03d80d248aa 58118-2331 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Clinical Solutions Wholesale GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 58118-2332_1ee59e1b-3d6f-4c36-b7a4-a03d80d248aa 58118-2332 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Clinical Solutions Wholesale GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 58118-2343_89dcb53f-080c-409a-ba85-ec0271be7653 58118-2343 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070995 Clinical Solutions Wholesale VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 58118-2433_e20b6595-6316-41a0-8425-44149925f892 58118-2433 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040738 Clinical Solutions Wholesale BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 58118-2434_e20b6595-6316-41a0-8425-44149925f892 58118-2434 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040742 Clinical Solutions Wholesale BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 58118-2435_e20b6595-6316-41a0-8425-44149925f892 58118-2435 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040715 Clinical Solutions Wholesale BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 58118-2520_76633798-2f6c-4ca8-b45b-87ee2cd2075d 58118-2520 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822 ANDA ANDA089859 Clinical Solutions Wholesale CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 58118-2521_cde877d0-1afb-435d-9dc9-d1332dc5ed39 58118-2521 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110822 ANDA ANDA070035 Clinical Solutions Wholesale METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 58118-2522_cde877d0-1afb-435d-9dc9-d1332dc5ed39 58118-2522 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110822 ANDA ANDA070044 Clinical Solutions Wholesale METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 58118-2528_37d443cc-385c-44a3-aca2-6053b50ad5e9 58118-2528 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Clinical Solutions Wholesale ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 58118-2529_37d443cc-385c-44a3-aca2-6053b50ad5e9 58118-2529 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Clinical Solutions Wholesale ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 58118-2530_37d443cc-385c-44a3-aca2-6053b50ad5e9 58118-2530 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Clinical Solutions Wholesale ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 58118-2531_37d443cc-385c-44a3-aca2-6053b50ad5e9 58118-2531 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Clinical Solutions Wholesale ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 58118-2788_19b69b3c-bcc3-4e99-af99-aeb1cbe337b6 58118-2788 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 NDA NDA021447 Clinical Solutions Wholesale TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 58118-2957_0363ce0f-1700-4495-ac93-49a71b9866f7 58118-2957 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Clinical Solutions Wholesale CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 58118-2958_0363ce0f-1700-4495-ac93-49a71b9866f7 58118-2958 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Clinical Solutions Wholesale CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 58118-2959_0363ce0f-1700-4495-ac93-49a71b9866f7 58118-2959 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Clinical Solutions Wholesale CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 58118-3078_b90564b6-17aa-46bd-a06d-70217dd58a30 58118-3078 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 Clinical Solutions Wholesale CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 58118-3142_179509de-4762-441e-88dd-ead9a2969a70 58118-3142 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840507 ANDA ANDA062396 Clinical Solutions Wholesale DOXYCYCLINE HYCLATE 100 mg/1 58118-3162_3a4093e8-25fa-4a5f-bc19-134d54d15c4d 58118-3162 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20100604 ANDA ANDA040756 Clinical Solutions Wholesale FOLIC ACID 1 mg/1 58118-3268_5c119bb6-15a7-424a-837f-9458b17c53f2 58118-3268 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100429 NDA NDA022104 Clinical Solutions Wholesale VENLAFAXINE HYDROCHLORIDE 225 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-3270_319a4ab5-8e8f-4eb3-a250-f1b09f4d78b8 58118-3270 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20100115 NDA NDA021427 Clinical Solutions Wholesale DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-3339_25e337a9-eb0e-4464-870d-c9f3ed0a151f 58118-3339 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 Clinical Solutions Wholesale DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 58118-3340_b73073c5-02ca-4b45-a780-93d03f12a391 58118-3340 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 Clinical Solutions Wholesale DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 58118-3467_71a0dc71-0357-4172-952b-3267c0b8d6a3 58118-3467 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET ORAL 20000530 OTC MONOGRAPH FINAL part341 Clinical Solutions Wholesale CHLORPHENIRAMINE MALEATE 4 mg/1 58118-3525_5d787eec-327a-46a5-8913-b957818f0921 58118-3525 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine PATCH CUTANEOUS 20130915 ANDA ANDA200675 Clinical Solutions Wholesale LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 58118-3541_da0b194b-13ba-4437-9409-7c4aae80067e 58118-3541 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 Clinical Solutions Wholesale BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 58118-3670_cb2e1f40-acec-475c-bd74-5f9c32e55d6d 58118-3670 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20110613 ANDA ANDA091083 Clinical Solutions Wholesale NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-3741_f0b91a16-b960-4cbb-aec4-269209a414f5 58118-3741 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 Clinical Solutions Wholesale FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 58118-3750_fc10b6de-3dbd-4f8a-8049-def272d0a2f1 58118-3750 HUMAN PRESCRIPTION DRUG Phenytek phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20011210 ANDA ANDA040298 Clinical Solutions Wholesale PHENYTOIN SODIUM 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 58118-3780_cd685044-32b2-4e41-a072-c52d920a69dc 58118-3780 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 NDA AUTHORIZED GENERIC NDA020699 Clinical Solutions Wholesale VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-4012_9b3648d0-2a79-42ee-8310-779d73fbdf24 58118-4012 HUMAN PRESCRIPTION DRUG Valproic Valproic Acid CAPSULE, LIQUID FILLED ORAL 20090908 ANDA ANDA073229 Clinical Solutions Wholesale VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 58118-4018_0b14c8c1-0212-4afe-9ec1-feabfd75fcde 58118-4018 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980311 ANDA ANDA075074 Clinical Solutions Wholesale ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-4027_339ad563-c48b-404f-96a0-94d5913d3a60 58118-4027 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Clinical Solutions Wholesale WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 58118-4028_6ae27b47-2740-40b9-bb38-63732d4552f4 58118-4028 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Clinical Solutions Wholesale WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 58118-4029_339ad563-c48b-404f-96a0-94d5913d3a60 58118-4029 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Clinical Solutions Wholesale WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 58118-4030_339ad563-c48b-404f-96a0-94d5913d3a60 58118-4030 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Clinical Solutions Wholesale WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 58118-4031_339ad563-c48b-404f-96a0-94d5913d3a60 58118-4031 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Clinical Solutions Wholesale WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 58118-4032_6ae27b47-2740-40b9-bb38-63732d4552f4 58118-4032 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Clinical Solutions Wholesale WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 58118-4033_339ad563-c48b-404f-96a0-94d5913d3a60 58118-4033 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Clinical Solutions Wholesale WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 58118-4034_339ad563-c48b-404f-96a0-94d5913d3a60 58118-4034 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Clinical Solutions Wholesale WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 58118-4035_339ad563-c48b-404f-96a0-94d5913d3a60 58118-4035 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Clinical Solutions Wholesale WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 58118-4129_319c7e12-bcbf-447b-9861-92d367a20182 58118-4129 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20071214 ANDA ANDA070719 Clinical Solutions Wholesale INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-4130_319c7e12-bcbf-447b-9861-92d367a20182 58118-4130 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20071214 ANDA ANDA070756 Clinical Solutions Wholesale INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-4132_e4629a6b-9d62-4cd8-a267-fd0449528b67 58118-4132 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078525 Clinical Solutions Wholesale LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 58118-4297_2b43670e-8e3e-409c-910e-d08312a70b17 58118-4297 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 Clinical Solutions Wholesale FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 58118-4299_2b43670e-8e3e-409c-910e-d08312a70b17 58118-4299 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 Clinical Solutions Wholesale FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 58118-4486_ddea431a-9b62-475b-84ff-58ce4ae74ce2 58118-4486 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Clinical Solutions Wholesale METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 58118-4725_ff3ca7c8-d501-42b0-835b-9d2cb0444843 58118-4725 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20121203 ANDA ANDA076688 Clinical Solutions Wholesale BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 58118-4728_1fd52caf-6020-49ab-9555-139dbf5c48e6 58118-4728 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 Clinical Solutions Wholesale PREDNISONE 5 mg/1 58118-4742_41b9ae5f-eb66-47c9-b17e-7e9baea64b83 58118-4742 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20071108 ANDA ANDA077048 Clinical Solutions Wholesale CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-4745_ff3ca7c8-d501-42b0-835b-9d2cb0444843 58118-4745 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20121203 ANDA ANDA076688 Clinical Solutions Wholesale BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 58118-4775_ff3ca7c8-d501-42b0-835b-9d2cb0444843 58118-4775 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20121203 ANDA ANDA076688 Clinical Solutions Wholesale BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 58118-5008_c96b4e16-3f5d-4792-86d3-ed9b0dbf65e4 58118-5008 HUMAN PRESCRIPTION DRUG misoprostol MISOPROSTOL TABLET ORAL 20091227 NDA AUTHORIZED GENERIC NDA019268 Clinical Solutions Wholesale MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 58118-5016_2708d896-af84-4cd5-bb25-96ef2625992b 58118-5016 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 19900129 NDA AUTHORIZED GENERIC NDA019949 Clinical Solutions Wholesale FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 58118-5017_a99ebebb-fde6-4ab9-911a-3d655345f579 58118-5017 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19981120 ANDA ANDA075229 Clinical Solutions Wholesale DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58118-5018_2708d896-af84-4cd5-bb25-96ef2625992b 58118-5018 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 19900129 NDA AUTHORIZED GENERIC NDA019949 Clinical Solutions Wholesale FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 58118-5027_be5faf00-77d0-4b85-b1ea-fb2392bb837e 58118-5027 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 Clinical Solutions Wholesale FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 58118-5040_0a4e27bd-151c-462f-ac47-4d0a1105aa9d 58118-5040 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010319 NDA NDA021153 Clinical Solutions Wholesale ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 58118-5060_20c06f4c-639a-4de3-846f-7754537dc935 58118-5060 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Clinical Solutions Wholesale PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 58118-5061_20c06f4c-639a-4de3-846f-7754537dc935 58118-5061 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Clinical Solutions Wholesale PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 58118-5062_20c06f4c-639a-4de3-846f-7754537dc935 58118-5062 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Clinical Solutions Wholesale PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 58118-5063_20c06f4c-639a-4de3-846f-7754537dc935 58118-5063 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Clinical Solutions Wholesale PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 58118-5105_0e8b4fbd-84c6-47a3-8e90-99e2a3b2abc9 58118-5105 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076133 Clinical Solutions Wholesale OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 58118-5135_17079b90-ccb2-4f35-8641-fdf3613d834f 58118-5135 HUMAN OTC DRUG Pain Reliever Plus Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Clinical Solutions Wholesale ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 58118-5209_e24487fe-d26a-464f-b8eb-952fc661af78 58118-5209 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET ORAL 20100524 ANDA ANDA077478 Clinical Solutions Wholesale VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 58118-5229_2826f0b7-6b22-4721-9e0c-7a5d3cdee65f 58118-5229 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET ORAL 19970109 ANDA ANDA074661 Clinical Solutions Wholesale NAPROXEN SODIUM 220 mg/1 58118-5307_0fb3e901-cbdc-4c4b-86a2-3ddae1ed9d36 58118-5307 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19730919 ANDA ANDA083426 Clinical Solutions Wholesale PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 58118-5338_615999fd-5d15-45fb-b04f-bd6df2b40e31 58118-5338 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Clinical Solutions Wholesale PREDNISONE 10 mg/1 58118-5420_6c6f14bb-c964-42a6-93a6-192204ae1b99 58118-5420 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20130301 ANDA ANDA078670 Clinical Solutions Wholesale PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 58118-5483_10509570-dac0-4042-8afa-d19db552195e 58118-5483 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070218 Clinical Solutions Wholesale PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 58118-5522_21c80507-9f7c-4325-bf0b-63b9feb4558e 58118-5522 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20100201 ANDA ANDA076509 Clinical Solutions Wholesale FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 58118-5560_b81beb8c-e93d-4e09-8fd2-ea6f543e894c 58118-5560 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET, FILM COATED ORAL 20120803 ANDA ANDA200889 Clinical Solutions Wholesale MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 58118-5683_ea895ba9-8094-4fc5-b604-7098b2682a65 58118-5683 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Clinical Solutions Wholesale RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 58118-5684_ea895ba9-8094-4fc5-b604-7098b2682a65 58118-5684 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Clinical Solutions Wholesale RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 58118-5685_ea895ba9-8094-4fc5-b604-7098b2682a65 58118-5685 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Clinical Solutions Wholesale RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 58118-5686_ea895ba9-8094-4fc5-b604-7098b2682a65 58118-5686 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Clinical Solutions Wholesale RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 58118-5688_ea895ba9-8094-4fc5-b604-7098b2682a65 58118-5688 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Clinical Solutions Wholesale RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 58118-5689_ea895ba9-8094-4fc5-b604-7098b2682a65 58118-5689 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Clinical Solutions Wholesale RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 58118-5767_e5faab3f-faf5-4144-934d-433b03c3e588 58118-5767 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Clinical Solutions Wholesale OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 58118-5768_e5faab3f-faf5-4144-934d-433b03c3e588 58118-5768 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Clinical Solutions Wholesale OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 58118-5770_e5faab3f-faf5-4144-934d-433b03c3e588 58118-5770 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Clinical Solutions Wholesale OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 58118-5771_e5faab3f-faf5-4144-934d-433b03c3e588 58118-5771 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Clinical Solutions Wholesale OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 58118-5791_bc76d855-d0f5-4152-9348-e7aa81913688 58118-5791 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Clinical Solutions Wholesale LEVOFLOXACIN 500 mg/1 58118-6149_7d3851d0-28ac-4885-8acd-1703a7b73882 58118-6149 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20100804 ANDA ANDA090027 Clinical Solutions Wholesale VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-6150_7d3851d0-28ac-4885-8acd-1703a7b73882 58118-6150 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20100804 ANDA ANDA090027 Clinical Solutions Wholesale VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-6151_7d3851d0-28ac-4885-8acd-1703a7b73882 58118-6151 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20100804 ANDA ANDA090027 Clinical Solutions Wholesale VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-6156_7d3851d0-28ac-4885-8acd-1703a7b73882 58118-6156 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20100804 ANDA ANDA090027 Clinical Solutions Wholesale VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-6157_7d3851d0-28ac-4885-8acd-1703a7b73882 58118-6157 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20100804 ANDA ANDA090027 Clinical Solutions Wholesale VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58118-6240_d7ae8170-640c-40ad-94f5-a5145f77aad9 58118-6240 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 19981224 ANDA ANDA040254 Clinical Solutions Wholesale TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 58118-6241_d7ae8170-640c-40ad-94f5-a5145f77aad9 58118-6241 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 19981224 ANDA ANDA040254 Clinical Solutions Wholesale TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 58118-6666_28e95ab0-1a7f-40dd-af0e-e54378ca06f6 58118-6666 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA078050 Clinical Solutions Wholesale ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 58118-7147_6f4e9c9e-fdab-45ca-be21-9ff6fd39e21e 58118-7147 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065150 Clinical Solutions Wholesale AZITHROMYCIN MONOHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 58118-7169_8b3648cb-b128-431d-890c-ae83d9e62e67 58118-7169 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065193 Clinical Solutions Wholesale AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 58118-7212_120a0a68-fc51-4dce-957d-a30d9bbc4942 58118-7212 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20050413 ANDA ANDA076864 Clinical Solutions Wholesale METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 58118-7355_69c41981-270d-4d16-9b28-035093bad53b 58118-7355 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20061215 ANDA ANDA076511 Clinical Solutions Wholesale FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 58118-7366_5a94fb1c-5069-4a84-963c-60e18c36cbc3 58118-7366 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Clinical Solutions Wholesale LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 58118-7889_ab54f017-dc91-4777-9e3a-e765ec375b71 58118-7889 HUMAN OTC DRUG MAJOR DOK Docusate Sodium DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100423 OTC MONOGRAPH NOT FINAL part334 Clinical Solutions Wholesale DOCUSATE SODIUM 100 mg/1 58118-7915_85ab4804-1090-4bc8-9fb9-dd77f2584ffd 58118-7915 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 OTC MONOGRAPH NOT FINAL part343 Clinical Solutions Wholesale IBUPROFEN 200 mg/1 58118-7927_f97e277d-2fb1-4fad-845a-a1d5541dad73 58118-7927 HUMAN OTC DRUG Bisacodyl Enteric Coated Bisacodyl TABLET, COATED ORAL 20081024 OTC MONOGRAPH NOT FINAL part334 Clinical Solutions Wholesale BISACODYL 5 mg/1 58118-8343_58311885-ab81-4c8d-b207-bac169f722a0 58118-8343 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Clinical Solutions Wholesale GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 58118-8344_7fc8569f-21a8-449f-87be-e410ea530c4e 58118-8344 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Clinical Solutions Wholesale GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 58118-8943_296069b8-5817-4f6f-970d-fd93daf6cf63 58118-8943 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970423 ANDA ANDA074556 Clinical Solutions Wholesale ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 58118-8947_296069b8-5817-4f6f-970d-fd93daf6cf63 58118-8947 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970430 ANDA ANDA074556 Clinical Solutions Wholesale ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 58118-9130_951b414d-6e87-45f3-a5a4-3241317d941c 58118-9130 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20110101 ANDA ANDA077836 Clinical Solutions Wholesale GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 58118-9738_530037d8-a9b8-4df0-8dcb-80022cb87ef8 58118-9738 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 Clinical Solutions Wholesale PREDNISONE 20 mg/1 58118-9825_1c4db12f-285b-4714-9b1c-26bcdc39cebf 58118-9825 HUMAN PRESCRIPTION DRUG CIPRODEX ciprofloxacin and dexamethasone SUSPENSION AURICULAR (OTIC) 20030815 NDA NDA021537 Clinical Solutions Wholesale CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE 3; 1 mg/mL; mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 58118-9827_b61d1ed9-1af8-4134-8086-6b6d89dceb6f 58118-9827 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC) 20080317 ANDA ANDA076128 Clinical Solutions Wholesale OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 58118-9839_616824aa-5865-4d68-9e3a-9ff8aa4fb05e 58118-9839 HUMAN PRESCRIPTION DRUG Prednisolone Acetate Prednisolone Acetate SUSPENSION OPHTHALMIC 19941215 NDA AUTHORIZED GENERIC NDA017469 Clinical Solutions Wholesale PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 58118-9842_0d026350-1c4e-4377-b24e-b586cbc794e5 58118-9842 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 19971020 ANDA ANDA074612 Clinical Solutions Wholesale NICOTINE 21 mg/24h 58118-9854_6f62bc79-0b52-44ce-8be0-3c4fdce667a2 58118-9854 HUMAN OTC DRUG New Terocin Methyl Salicylate, Capsaicin, and Menthol LOTION TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part348 Clinical Solutions Wholesale CAPSAICIN; MENTHOL; METHYL SALICYLATE .025; 10; 25 g/100mL; g/100mL; g/100mL 58118-9893_e1256852-fbe7-441e-8d39-1c78c9805ddb 58118-9893 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 19940511 ANDA ANDA064048 Clinical Solutions Wholesale GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 58118-9894_3c582ede-e690-4c38-a949-c1ff3a566416 58118-9894 HUMAN OTC DRUG Major Clotrimazole CLOTRIMAZOLE CREAM TOPICAL 20041004 OTC MONOGRAPH FINAL part333C Clinical Solutions Wholesale CLOTRIMAZOLE 10 mg/g 58118-9895_80abe660-b39b-4f59-9d30-192670706490 58118-9895 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin CREAM TOPICAL 19981224 ANDA ANDA075265 Clinical Solutions Wholesale TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 58118-9896_73f68f97-ad3a-492b-a96d-304b464ffd03 58118-9896 HUMAN OTC DRUG MUCUS RELIEF GUAIFENESIN TABLET ORAL 20120723 OTC MONOGRAPH FINAL part341 Clinical Solutions Wholesale GUAIFENESIN 400 mg/1 58118-9918_ae8bd80f-0a15-42cb-855e-3bcc0b3626c6 58118-9918 HUMAN PRESCRIPTION DRUG PrednisoLONE Prednisolone SYRUP ORAL 20070921 ANDA ANDA040775 Clinical Solutions Wholesale PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 58118-9923_c1662a69-233d-43ca-a6e6-cfd2dc0b766e 58118-9923 HUMAN PRESCRIPTION DRUG POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate SOLUTION/ DROPS OPHTHALMIC 19970429 NDA AUTHORIZED GENERIC NDA050567 Clinical Solutions Wholesale POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 58118-9924_4b25a7ef-8829-4680-a19b-916ee71b40e6 58118-9924 HUMAN PRESCRIPTION DRUG PATANASE olopatadine hydrochloride SPRAY, METERED NASAL 20080428 NDA NDA021861 Clinical Solutions Wholesale OLOPATADINE HYDROCHLORIDE 665 ug/1 Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 58118-9928_f92bfa69-8a36-4f65-8fac-489f50ae48e8 58118-9928 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20040514 ANDA ANDA076622 Clinical Solutions Wholesale OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 58118-9931_5cc96e4f-81d1-4ce0-a6ea-c201f39f71c2 58118-9931 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19960828 ANDA ANDA064065 Clinical Solutions Wholesale HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 58118-9932_15017193-2692-4285-8d08-0fa65d649fac 58118-9932 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20050923 ANDA ANDA065170 Clinical Solutions Wholesale MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 58118-9938_08785c8f-3404-443a-a739-42659604f569 58118-9938 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION OROPHARYNGEAL 20070227 ANDA ANDA040708 Clinical Solutions Wholesale LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 58118-9969_506d370a-53ef-4234-87c4-9c1324df3db7 58118-9969 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20050121 ANDA ANDA076673 Clinical Solutions Wholesale CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 58118-9974_ee96536a-cd94-45aa-a5bb-60425b557be7 58118-9974 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20071214 ANDA ANDA065473 Clinical Solutions Wholesale CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 58118-9978_7e018414-ac11-4a0d-9e72-415715724822 58118-9978 HUMAN PRESCRIPTION DRUG Bromfed DM Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide SYRUP ORAL 20090821 ANDA ANDA088811 Clinical Solutions Wholesale BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 10; 30 mg/5mL; mg/5mL; mg/5mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] 58120-001_12f5a913-ffd6-49a1-a344-f6806044d68d 58120-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19800101 UNAPPROVED MEDICAL GAS Home Care Medical, Inc OXYGEN 990 mL/L 58125-0001_61ddf592-1b37-4c28-b753-65f8a958d534 58125-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19940526 UNAPPROVED MEDICAL GAS Resp-I-Care, Inc. OXYGEN 99 L/100L 58128-0001_cbb67ed3-0e26-491c-8e69-210d04b73380 58128-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19900504 UNAPPROVED MEDICAL GAS Family Medical Supply Inc. OXYGEN 99 L/100L 58132-3331_c2b362c3-36dc-40ef-91be-242d45a09b47 58132-3331 HUMAN OTC DRUG Alcis Daily Relief Pain Relief Trolamine Salicylate CREAM TOPICAL 20090309 OTC MONOGRAPH NOT FINAL part348 Alcis Topical, Inc. TROLAMINE SALICYLATE 10 g/100mL 58133-001_2f35d74d-d185-43b3-841e-6eaeef127ff9 58133-001 HUMAN OTC DRUG Marathon Pain Relief Topical Analgesic Menthol 3.0% LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part348 Cosmetic Specialty labs, Inc. MENTHOL 3 g/100g 58133-049_20453893-3b4e-4eb5-9d1b-e2afef350940 58133-049 HUMAN OTC DRUG Miracle Pain Cream Menthol CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part348 Cosmetic Specialty labs, Inc. MENTHOL 3 g/100g 58133-051_78409d57-bdc7-41b6-a531-ed2a341a760b 58133-051 HUMAN OTC DRUG White Real Time Pain Relief Topical Analgesic Menthol 1% LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part348 Cosmetic Specialty labs, Inc. MENTHOL 1 g/100mL 58133-052_3d4dd63b-b02e-464d-aa9e-6a0b3471aa26 58133-052 HUMAN OTC DRUG Real Time Pain Relief Topical Analgesic Menthol 1% LOTION TOPICAL 20130130 OTC MONOGRAPH NOT FINAL part348 Cosmetic Specialty labs, Inc. MENTHOL 1 g/100mL 58133-055_1d8d9dbb-4554-49ea-98ea-d63e508f34fd 58133-055 HUMAN OTC DRUG BerbereX Wound Cleanser Allantoin, Benzethonium Chloride SOLUTION TOPICAL 20130915 OTC MONOGRAPH NOT FINAL part333A Cosmetic Specialty Labs, Inc. ALLANTOIN; BENZETHONIUM CHLORIDE 5; 1 g/1000mL; g/1000mL 58133-062_ff70bbb4-b434-483f-a510-3b811a1b331b 58133-062 HUMAN OTC DRUG LEROSETT High-Content Organic Acne Treatment Botanically Based Salicylic Acid GEL TOPICAL 20130101 OTC MONOGRAPH FINAL part333D Cosmetic Specialty labs, Inc. SALICYLIC ACID 2 g/100mL 58133-075_5ef26b5b-5f72-4f45-8d89-8d40b704a38a 58133-075 HUMAN OTC DRUG Red Lion Relief Menthol CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part348 Cosmetic Specialty labs, Inc. MENTHOL 3 g/100g 58142-7115_f19fc070-34cd-4406-8a5c-ef569b40f580 58142-7115 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS St. John's Medical Supply OXYGEN 99 L/100L 58154-100_97e6afc8-b5b0-452c-ba0c-3f64d167e216 58154-100 HUMAN OTC DRUG healthy mama SHAKE THAT ACHE ACETAMINOPHEN TABLET ORAL 20130418 OTC MONOGRAPH NOT FINAL part343 MATERNAL SCIENCE, LLC ACETAMINOPHEN 500 mg/1 58154-101_7ccb92e7-2d83-4019-a1f2-2c1e8dbf368d 58154-101 HUMAN OTC DRUG healthy mama MOVE IT ALONG DOCUSATE SODIUM TABLET, FILM COATED ORAL 20130423 OTC MONOGRAPH NOT FINAL part334 MATERNAL SCIENCE, LLC DOCUSATE SODIUM 100 mg/1 58154-103_a8d94f7e-d26d-4d69-a627-fe13cce0a295 58154-103 HUMAN OTC DRUG healthy mama TAME THE FLAME CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20130531 OTC MONOGRAPH FINAL part331 MATERNAL SCIENCE, LLC CALCIUM CARBONATE 500 mg/1 58154-104_cc2e8b60-ef3f-4c01-995f-5bc16d065432 58154-104 HUMAN OTC DRUG healthy mama eaZZZe THE PAIN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130429 OTC MONOGRAPH NOT FINAL part343 MATERNAL SCIENCE, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 58154-107_88b9de99-b1a3-41ae-b06c-65c819fa94bb 58154-107 HUMAN PRESCRIPTION DRUG healthy mamaBE WELL ROUNDED BE WELL ROUNDED .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS BISGLYCINATE, ZINC OXIDE, COPPER, CALCIUM PANTOTHENATE,MAGNESIUM OXIDE TABLET, FILM COATED ORAL 20130709 UNAPPROVED DRUG OTHER MATERNAL SCIENCE, LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; COPPER; FERROUS BISGLYCINATE; FOLIC ACID; MAGNESIUM OXIDE; METHYLCOBALAMIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE; ZINC OXIDE 30; 4000; 120; 30; 200; 10; 400; 2; 28; 800; 30; 8; 20; 2.6; 1.7; 1.8; 25 [iU]/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 58155-131_fbb6b0a8-4f9f-4dc4-a748-46943aa02807 58155-131 HUMAN OTC DRUG MoistureWorx White Petrolatum SPRAY TOPICAL 20130626 OTC MONOGRAPH FINAL part347 Juventio LLC PETROLATUM 36 g/120mL 58160-806_62cc26ba-c585-441b-a6cf-dea7c4495922 58160-806 VACCINE HIBERIX Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20090824 BLA BLA125347 GlaxoSmithKline Biologicals SA HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN 10 ug/.5mL Inactivated Haemophilus Influenzae B Vaccine [EPC],Actively Acquired Immunity [PE],Haemophilus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 58160-809_797266bb-89bd-4b2a-a052-8fd518f2471d 58160-809 VACCINE MENHIBRIX Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20130903 BLA BLA125363 GlaxoSmithKline Biologicals SA HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE ANTIGEN; NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE ANTIGEN 2.5; 5; 5 ug/.5mL; ug/.5mL; ug/.5mL Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Haemophilus Influenzae B Vaccine [EPC],Actively Acquired Immunity [PE],Haemophilus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 58160-810_86d89a2e-32b2-4f06-80d8-d4a7a6445481 58160-810 VACCINE INFANRIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed SUSPENSION INTRAMUSCULAR 20090724 BLA BLA103647 GlaxoSmithKline Biologicals SA BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 25; 8; 25; 10; 25 ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient] 58160-811_18e1867d-7ffd-4efe-b2cd-add368b49883 58160-811 VACCINE PEDIARIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined INJECTION, SUSPENSION INTRAMUSCULAR 20090724 BLA BLA103907 GlaxoSmithKline Biologicals SA BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 25; 8; 25; 10; 25; 10; 40; 8; 32 ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 58160-812_2ed00458-539f-45eb-bd99-2f7da2561344 58160-812 VACCINE KINRIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20080709 BLA BLA125260 GlaxoSmithKline Biologicals SA BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 25; 8; 25; 10; 25; 40; 8; 32 [iU]/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 58160-815_520d0414-e06f-4434-bcaf-bd2cad39cbe3 58160-815 VACCINE TWINRIX Hepatitis A and Hepatitis B (Recombinant) Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20070607 BLA BLA103850 GlaxoSmithKline Biologicals SA HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 720; 20 [iU]/mL; ug/mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 58160-820_b1b9a5ca-727b-4154-8c98-3e7c5a720983 58160-820 VACCINE ENGERIX-B Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR 20070425 BLA BLA103239 GlaxoSmithKline Biologicals SA HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 10 ug/.5mL 58160-821_b1b9a5ca-727b-4154-8c98-3e7c5a720983 58160-821 VACCINE ENGERIX-B Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR 20070328 BLA BLA103239 GlaxoSmithKline Biologicals SA HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 20 ug/mL 58160-825_a993d98a-a8d7-422b-8aa9-9cc57a876f22 58160-825 VACCINE HAVRIX Hepatitis A Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20070216 BLA BLA103475 GlaxoSmithKline Biologicals SA HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 720 [iU]/.5mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 58160-826_a993d98a-a8d7-422b-8aa9-9cc57a876f22 58160-826 VACCINE HAVRIX Hepatitis A Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20070413 BLA BLA103475 GlaxoSmithKline Biologicals SA HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 1440 [iU]/mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 58160-830_91f5aed6-9487-4c54-ac8b-a2e5ccee6aa0 58160-830 VACCINE CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant INJECTION, SUSPENSION INTRAMUSCULAR 20091016 BLA BLA125259 GlaxoSmithKline Biologicals SA HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN RESIDUES 2-471 ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN RESIDUES 2-472 ANTIGEN 20; 20 ug/.5mL; ug/.5mL 58160-842_373ab4b8-4337-4b0a-94d4-03ea8829cbab 58160-842 VACCINE BOOSTRIX Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed SUSPENSION INTRAMUSCULAR 20090724 BLA BLA125106 GlaxoSmithKline Biologicals SA BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 8; 2.5; 8; 5; 2.5 ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient] 58160-854_f0a81c45-85e5-44b5-a0e7-d22c922632b2 58160-854 VACCINE ROTARIX Rotavirus Vaccine, Live, Oral KIT 20110113 BLA BLA125265 GlaxoSmithKline Biologicals SA 58160-881_08d6d6b3-5257-4c6b-b5bf-57b41609cc62 58160-881 VACCINE FLUARIX 2014/2015 influenza virus vaccine SUSPENSION INTRAMUSCULAR 20140627 BLA BLA125127 GlaxoSmithKline Biologicals SA INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL 58160-901_8dd12623-6a3d-48e6-92b9-89112e25f848 58160-901 VACCINE FLUARIX QUADRIVALENT 2014/2015 influenza virus vaccine SUSPENSION INTRAMUSCULAR 20140701 BLA BLA125127 GlaxoSmithKline Biologicals SA INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED) 15; 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL 58161-155_5087f840-3789-4245-83cf-62aac3c7bf6d 58161-155 HUMAN OTC DRUG Dr.Phi Instant Hand Sanitizer Dr.Phi Instant Hand Sanitizer GEL TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part333A MAMIBA ALCOHOL .7 mL/mL 58162-100_5b805bf0-8293-4837-9896-effc251fd108 58162-100 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20130401 UNAPPROVED MEDICAL GAS Vagabond Welding Supply OXYGEN 99 L/100L 58162-200_9210715d-21c1-433a-8582-765be4dd0d27 58162-200 HUMAN PRESCRIPTION DRUG AIR COMPRESSED MEDICAL AIR OXYGEN, NITROGEN GAS RESPIRATORY (INHALATION) 20130401 UNAPPROVED MEDICAL GAS Vagabond Welding Supply OXYGEN 21 L/100L 58165-028_45bc21f6-150d-e5e0-4d8d-a00d890a161e 58165-028 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, COATED ORAL 20100608 ANDA ANDA077784 Ratiopharm Inc RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 58165-029_45bc21f6-150d-e5e0-4d8d-a00d890a161e 58165-029 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, COATED ORAL 20100608 ANDA ANDA077784 Ratiopharm Inc RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 58165-030_45bc21f6-150d-e5e0-4d8d-a00d890a161e 58165-030 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, COATED ORAL 20100608 ANDA ANDA077784 Ratiopharm Inc RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 58165-031_45bc21f6-150d-e5e0-4d8d-a00d890a161e 58165-031 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, COATED ORAL 20100608 ANDA ANDA077784 Ratiopharm Inc RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 58165-032_45bc21f6-150d-e5e0-4d8d-a00d890a161e 58165-032 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, COATED ORAL 20100608 ANDA ANDA077784 Ratiopharm Inc RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 58165-033_45bc21f6-150d-e5e0-4d8d-a00d890a161e 58165-033 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, COATED ORAL 20100608 ANDA ANDA077784 Ratiopharm Inc RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 58166-001_8a139a1c-8df1-4ceb-93c8-26480833b118 58166-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20130401 UNAPPROVED MEDICAL GAS Lynarc Welding Supplies & Material Inc. OXYGEN 99 L/100L 58167-112_635414da-adef-4eac-be68-daf3f35f892e 58167-112 HUMAN OTC DRUG Mata Balm Camphor, Menthol OINTMENT TOPICAL 20130427 OTC MONOGRAPH NOT FINAL part348 Amata LLC CAMPHOR (NATURAL); MENTHOL 45; 367 mg/g; mg/g 58177-293_68235c8d-a5fa-49c8-aebd-214e6c47e410 58177-293 HUMAN PRESCRIPTION DRUG metoprolol succinate extended-release metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091101 ANDA ANDA077176 Ethex Corporation METOPROLOL SUCCINATE 23.75 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 58177-310_44b9cb00-c457-4cc3-99e3-0db1be101fcd 58177-310 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091203 ANDA ANDA076733 ETHEX Corporation MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 58177-311_1969d6f2-3f37-4317-a73b-09158f83e59c 58177-311 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate TABLET ORAL 20091101 ANDA ANDA040365 Ethex Corporation DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 58177-312_1969d6f2-3f37-4317-a73b-09158f83e59c 58177-312 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate TABLET ORAL 20091101 ANDA ANDA040367 Ethex Corporation DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 58177-320_44b9cb00-c457-4cc3-99e3-0db1be101fcd 58177-320 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100422 ANDA ANDA076720 ETHEX Corporation MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 58177-330_44b9cb00-c457-4cc3-99e3-0db1be101fcd 58177-330 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100422 ANDA ANDA076720 ETHEX Corporation MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 58177-340_44b9cb00-c457-4cc3-99e3-0db1be101fcd 58177-340 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090101 ANDA ANDA077855 ETHEX Corporation MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 58177-358_61be400f-687b-4db4-8d15-8a7c1f8318cf 58177-358 HUMAN PRESCRIPTION DRUG metoprolol succinate extended-release metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091101 ANDA ANDA076640 Ethex Corporation METOPROLOL SUCCINATE 190 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 58177-368_61be400f-687b-4db4-8d15-8a7c1f8318cf 58177-368 HUMAN PRESCRIPTION DRUG metoprolol succinate extended-release metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091101 ANDA ANDA076640 Ethex Corporation METOPROLOL SUCCINATE 90 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 58177-369_274e757d-643f-4964-bd47-18016789a4ea 58177-369 HUMAN PRESCRIPTION DRUG metoprolol succinate extended-release metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091101 ANDA ANDA077176 Ethex Corporation METOPROLOL SUCCINATE 47.5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 58177-380_44b9cb00-c457-4cc3-99e3-0db1be101fcd 58177-380 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090101 ANDA ANDA077855 ETHEX Corporation MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 58177-677_b09b8a7e-4a56-4b4e-b03b-2769a9ce8c62 58177-677 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride controlled-release oxycodone hydrochloride TABLET, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020553 Ethex Corporation OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 58177-679_b09b8a7e-4a56-4b4e-b03b-2769a9ce8c62 58177-679 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride controlled-release oxycodone hydrochloride TABLET, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020553 Ethex Corporation OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 58177-681_b09b8a7e-4a56-4b4e-b03b-2769a9ce8c62 58177-681 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride controlled-release oxycodone hydrochloride TABLET, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020553 Ethex Corporation OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 58177-683_b09b8a7e-4a56-4b4e-b03b-2769a9ce8c62 58177-683 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride controlled-release oxycodone hydrochloride TABLET, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020553 Ethex Corporation OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 58177-910_75b15fab-4e46-4382-8754-8a54d5fa676b 58177-910 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SYRUP ORAL 20040510 ANDA ANDA040364 ETHEX Corporation PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 58180-104_3cfa7ca6-a33b-45bd-b729-448dfb2fb863 58180-104 HUMAN OTC DRUG Angel of mine Diaper Rash Zinc Oxide OINTMENT TOPICAL 20141118 OTC MONOGRAPH FINAL part347 Bicooya Cosmetics Limited ZINC OXIDE 160 mg/g 58180-105_3e6ecd28-285c-4150-af64-0b636e0088b1 58180-105 HUMAN OTC DRUG Anti-Blemish Cleanser Salicylic Acid CREAM TOPICAL 20141216 OTC MONOGRAPH FINAL part358H Bicooya Cosmetics Limited SALICYLIC ACID 14 g/100g 58180-201_46bbfa7f-4f41-450a-b91a-206d7ce3dbef 58180-201 HUMAN OTC DRUG Assured T And Plus Coal Tar SHAMPOO TOPICAL 20140121 OTC MONOGRAPH FINAL part358H Bicooya Cosmetics Limited COAL TAR 5 mg/mL 58180-210_d7d08a8a-5c5e-40a2-a2de-cae21477127d 58180-210 HUMAN OTC DRUG Clean hand sanitizer Ethyl Alcohol SPRAY TOPICAL 20141209 OTC MONOGRAPH NOT FINAL part333A Bicooya Cosmetics Limited ALCOHOL 62 mL/100mL 58181-3030_bf4e02df-851e-4013-80d8-ae16ffcd9c12 58181-3030 HUMAN PRESCRIPTION DRUG Lomustine lomustine CAPSULE, GELATIN COATED ORAL 20140729 NDA NDA017588 NextSource Biotechnology, LLC LOMUSTINE 10 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 58181-3031_bf4e02df-851e-4013-80d8-ae16ffcd9c12 58181-3031 HUMAN PRESCRIPTION DRUG Lomustine lomustine CAPSULE, GELATIN COATED ORAL 20140729 NDA NDA017588 NextSource Biotechnology, LLC LOMUSTINE 40 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 58181-3032_bf4e02df-851e-4013-80d8-ae16ffcd9c12 58181-3032 HUMAN PRESCRIPTION DRUG Lomustine lomustine CAPSULE, GELATIN COATED ORAL 20140729 NDA NDA017588 NextSource Biotechnology, LLC LOMUSTINE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 58181-3040_6bec3b5f-961e-44e8-aa23-8e61a9fcff45 58181-3040 HUMAN PRESCRIPTION DRUG Gleostine lomustine CAPSULE, GELATIN COATED ORAL 20140818 NDA NDA017588 NextSource Biotechnology, LLC LOMUSTINE 10 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 58181-3041_6bec3b5f-961e-44e8-aa23-8e61a9fcff45 58181-3041 HUMAN PRESCRIPTION DRUG Gleostine lomustine CAPSULE, GELATIN COATED ORAL 20140818 NDA NDA017588 NextSource Biotechnology, LLC LOMUSTINE 40 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 58181-3042_6bec3b5f-961e-44e8-aa23-8e61a9fcff45 58181-3042 HUMAN PRESCRIPTION DRUG Gleostine lomustine CAPSULE, GELATIN COATED ORAL 20140818 NDA NDA017588 NextSource Biotechnology, LLC LOMUSTINE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 58194-001_2a11e608-3d1c-4fb4-a434-1a10fa697cff 58194-001 HUMAN OTC DRUG Modesa anti-bacterial hand gel Ethyl Alcohol GEL TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL 58194-002_40850807-7d60-46c8-a030-019bd469dd12 58194-002 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 68 mL/100mL 58194-003_59376a6c-e672-4282-827f-958d58e6e665 58194-003 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 68 mL/100mL 58194-004_28256b1f-829d-4b87-b172-4b752337ec86 58194-004 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 68 mL/100mL 58194-005_072b9a9c-dbeb-4e06-8cbe-15e262d6cef0 58194-005 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 68 mL/100mL 58194-006_84c590e8-6f91-47c2-b865-d13644a44132 58194-006 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 68 mL/100mL 58194-007_456455cf-7860-4163-8a98-33c655e863ac 58194-007 HUMAN OTC DRUG Ocean Breeze Ethyl Alcohol GEL TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 68 mL/100mL 58194-009_4f4b7ce8-cde7-41f5-8f0d-393575868e32 58194-009 HUMAN OTC DRUG Ocean Breeze Ethyl Alcohol GEL TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL 58194-010_48d40991-9f76-426c-aea7-fed6013da07d 58194-010 HUMAN OTC DRUG marshmallow ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL 58194-011_29782872-781c-410c-a26f-37bda9e1a215 58194-011 HUMAN OTC DRUG bubble gum ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL 58194-012_467a7139-66fa-4620-985b-ab8c3a7511fa 58194-012 HUMAN OTC DRUG Candy Apple ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL 58194-013_834d0fd6-9364-4913-b009-ff5ea84c5b3e 58194-013 HUMAN OTC DRUG Cotton Candy ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL 58194-014_437960aa-8aea-4e3e-bbf5-67d05590a2a9 58194-014 HUMAN OTC DRUG Cupcake ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL 58194-015_6f095668-8182-4ee9-a549-e9dd2183244d 58194-015 HUMAN OTC DRUG Lollipop ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL 58194-016_6bf48bf9-dd1c-454a-b467-a90c719623d2 58194-016 HUMAN OTC DRUG Sweet Pea ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL 58194-017_8e6cd599-5644-4633-8cb1-a582734e83f8 58194-017 HUMAN OTC DRUG Unscented ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL 58194-018_4c6995b8-d3cf-42f5-9aa2-01d93d06258c 58194-018 HUMAN OTC DRUG Vanilla ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL 58194-019_44fdbbb2-43c6-47f3-a54c-c1add795b4d2 58194-019 HUMAN OTC DRUG Zesty Lemon ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL 58194-020_87f9037d-6db1-41f4-ad26-d4aef9e69528 58194-020 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL 58214-100_1dea5f49-ef1a-465f-9757-a50a0ed237c6 58214-100 HUMAN OTC DRUG beyond nicotine kit CALADIUM SEGUINUM, KALI SULPH, PLANTAGO MAJOR, NICOTIANA TABACUM, CALCIUM SULFATE ANHYDROUS, LOBELIA INFLATA, SAMBUCUS NIGRA FLOWERING TOP, DELPHINIUM STAPHISAGRIA SEED KIT ORAL; ORAL 20130417 UNAPPROVED HOMEOPATHIC JMSP USA LLC 58223-517_d0113e34-5ad7-ea20-42fc-4743b7ce0fe9 58223-517 HUMAN PRESCRIPTION DRUG FLURA-DROPS SODIUM FLUORIDE LIQUID ORAL 20140501 UNAPPROVED DRUG OTHER KIRKMAN GROUP, INC. SODIUM FLUORIDE 2.21 mg/.2mL 58223-678_4a15aadd-fee8-4ce3-24ad-a8e432f95625 58223-678 HUMAN PRESCRIPTION DRUG SODIUM FLUORIDE CHERRY SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20111001 UNAPPROVED DRUG OTHER KIRKMAN GROUP, INC. SODIUM FLUORIDE .5 mg/1 58223-679_f7008125-6c85-f35a-6972-2464381ceb05 58223-679 HUMAN PRESCRIPTION DRUG SODIUM FLUORIDE CHERRY SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20111001 UNAPPROVED DRUG OTHER KIRKMAN GROUP, INC. SODIUM FLUORIDE 1 mg/1 58228-0102_8af1b91c-d74f-4ba4-9543-2a176ed3631a 58228-0102 HUMAN OTC DRUG ProStat Protective Coating Bandage First Aid benzethonium chloride and benzocaine AEROSOL, SPRAY TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333A ProStat First Aid BENZETHONIUM CHLORIDE; BENZOCAINE 170; 2720 mg/85g; mg/85g 58228-0103_0cde8593-950a-43ce-be26-3c6f39291cd0 58228-0103 HUMAN OTC DRUG ProStat Blood Clotting First Aid benzethonium chloride and lidocaine AEROSOL, SPRAY TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part348 ProStat First Aid BENZETHONIUM CHLORIDE; LIDOCAINE 170; 3400 mg/85g; mg/85g 58228-0104_76ed0b78-ff53-4140-82d1-3d1fa32f8c63 58228-0104 HUMAN OTC DRUG ProStat Antiseptic First Aid benzocaine and benzethonium chloride AEROSOL, SPRAY TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part348 ProStat First Aid BENZETHONIUM CHLORIDE; BENZOCAINE 170; 8500 mg/85g; mg/85g 58228-0105_7518092e-2c65-42be-bf2e-8a665defe6c1 58228-0105 HUMAN OTC DRUG ProStat Burn First Aid benzethonium chloride, benzocaine, and menthol AEROSOL, SPRAY TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part348 ProStat First Aid BENZETHONIUM CHLORIDE; BENZOCAINE; MENTHOL 170; 8500; 281 mg/85g; mg/85g; mg/85g 58228-5600_fb769e20-f961-411c-a90f-6f064f5fdb7b 58228-5600 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20130920 OTC MONOGRAPH FINAL part333B ProStat First Aid BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 58231-001_4d01bfba-2dd9-4951-a761-8aa6f4f697bc 58231-001 HUMAN OTC DRUG Snowberry Zinc Oxide CREAM TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Snowberry New Zealand Ltd ETHYL FERULATE; KAEMPFERIA GALANGA ROOT; LARIX SIBIRICA WOOD; ZINC OXIDE .7; .7; .3; 1.6 g/10g; g/10g; g/10g; g/10g 58231-002_4de0e878-6b0f-40c5-ad03-c3c2ba54b9af 58231-002 HUMAN OTC DRUG Snowberry Zinc Oxide CREAM TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Snowberry New Zealand Ltd ETHYL FERULATE; KAEMPFERIA GALANGA ROOT; LARIX SIBIRICA WOOD; ZINC OXIDE .6; .7; .3; 2.2 g/10g; g/10g; g/10g; g/10g 58232-0001_92345e00-4980-4735-a27c-9badcc57887e 58232-0001 HUMAN OTC DRUG Aveeno Positively Radiant CC Broad Spectrum SPF30 - Medium Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20140428 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL 58232-0002_afe7edbc-0b4f-48c9-9fc4-f4e2b76b7dce 58232-0002 HUMAN OTC DRUG Aveeno Positively Radiant CC Broad Spectrum SPF30 - Fair to Light Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20140428 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL 58232-0006_70a2a18d-e079-4edc-a527-755500ac28a9 58232-0006 HUMAN OTC DRUG Clean and Clear Advantage 3 in 1 Exfoliating Benzoyl Peroxide CREAM TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BENZOYL PEROXIDE 50 mg/g 58232-0016_73389c24-ed0a-4b81-a7c8-34a52f1210b0 58232-0016 HUMAN OTC DRUG Band-Aid Brand Hurt-Free Antiseptic Wash Benzalkonium Chloride and Lidocaine Hydrochloride LIQUID TOPICAL 20111214 OTC MONOGRAPH NOT FINAL part333A Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 20 mg/mL; mg/mL 58232-0018_97a1e25e-3cc9-4766-a06c-857625024943 58232-0018 HUMAN OTC DRUG Aveeno Baby Eczema Therapy Soothing Bath Treatment Oatmeal POWDER TOPICAL 20111128 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. OATMEAL 430 mg/g 58232-0019_30af97c7-6404-4f35-a8ef-4d0a19e70a01 58232-0019 HUMAN OTC DRUG Aveeno Soothing Bath Treatment Oatmeal POWDER TOPICAL 20130620 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. OATMEAL 1000 mg/g 58232-0020_3da669e5-1670-4b14-9cb8-7306571c451b 58232-0020 HUMAN OTC DRUG Aveeno Baby Natural Protection MineralBlock Sunblock SPF 30 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. TITANIUM DIOXIDE; ZINC OXIDE 41.4; 28.8 mg/g; mg/g 58232-0021_d97f38a0-5690-4a1b-8451-4a6b20f1f11d 58232-0021 HUMAN OTC DRUG Aveeno Baby Natural Protection MineralBlock SPF 50plus Face Titanium Dioxide and Zinc Oxide STICK TOPICAL 20101201 20151018 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. TITANIUM DIOXIDE; ZINC OXIDE 83.8; 70.5 mg/g; mg/g 58232-0022_d5fbd872-1de1-4f5a-b491-174f86c19cc0 58232-0022 HUMAN OTC DRUG Aveeno Active Naturals Natural Protection MineralBlock SPF 30 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20101201 20171201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. TITANIUM DIOXIDE; ZINC OXIDE 41.4; 28.8 mg/g; mg/g 58232-0023_d90606b4-2a63-4e60-ab3b-543100dde1fa 58232-0023 HUMAN OTC DRUG Aveeno Active Naturals Hydrosport Sunblock SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20101015 20170301 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 33.5; 111.6; 55.8; 111.6; 55.8 mg/g; mg/g; mg/g; mg/g; mg/g 58232-0024_0b134905-bae6-4105-b332-f7311394672d 58232-0024 HUMAN OTC DRUG Aveeno Active Naturals Hydrosport Sunblock SPF 85 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20101015 20161201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 32.7; 163.5; 54.5; 109; 65.4 mg/g; mg/g; mg/g; mg/g; mg/g 58232-0025_996074c3-1b5b-43a1-a78a-dc3ba1f686d9 58232-0025 HUMAN OTC DRUG Aveeno Active Naturals Hydrosport Sunblock SPF 85 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20101015 20161201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28.8; 67.3; 48.1; 96.2; 57.7 mg/g; mg/g; mg/g; mg/g; mg/g 58232-0026_316de8dc-e22b-47dc-81d5-d79fc12c9ca2 58232-0026 HUMAN OTC DRUG Aveeno Active Naturals Smart Essentials Daily Nourishing Moisturizer SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20101201 20150601 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.4; 118; 49; 16.7; 29.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58232-0027_182268a4-5d74-41eb-9a4c-822ee144e877 58232-0027 HUMAN OTC DRUG Aveeno Active Naturals Positively Ageless Youth Perfecting Moisturizer SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100115 20150524 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.3; 121.2; 50.5; 17.2; 30.3 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58232-0029_f20c0c41-488e-46dd-ac8c-381e5b3d4c12 58232-0029 HUMAN OTC DRUG Aveeno Active Naturals Positively Ageless Daily Antioxidant Defense Moisturizer SPF 42 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20101101 20150701 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.8; 119.3; 49.7; 23.9; 59.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58232-0030_6001d093-b43c-4b49-9387-bd680670f46b 58232-0030 HUMAN OTC DRUG Clean and Clear Finishes Mattifying Moisturizer SPF 15 Octinoxate and Titanium Dioxide LOTION TOPICAL 20101201 20170101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. OCTINOXATE; TITANIUM DIOXIDE 80; 30 mg/g; mg/g 58232-0032_57fb1b45-68b6-4962-bf1b-5b9f2d9496d3 58232-0032 HUMAN OTC DRUG Clean and Clear Advantage Popped Pimple Relief Salicylic Acid PASTE TOPICAL 20101201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 5 mg/g 58232-0033_a9ec40da-ad05-408c-bc77-3783bf21e055 58232-0033 HUMAN OTC DRUG Clean and Clear Advantage Popped Pimple Relief Pen Salicylic Acid GEL TOPICAL 20110817 20170601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/g 58232-0034_215dbb3c-1853-4348-9749-87122ee820ab 58232-0034 HUMAN OTC DRUG Aveeno Active Naturals Skin Relief Calming Dimethicone CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIMETHICONE 12.5 mg/g 58232-0035_d1f3980e-f7bf-4ca9-845e-21253aee659e 58232-0035 HUMAN OTC DRUG Desitin Soothing Rash Bath Treatment Oatmeal POWDER TOPICAL 20110501 20150701 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. OATMEAL 43 mg/g 58232-0036_a2ca498c-76f9-4ccf-bcc0-59497dcc833a 58232-0036 HUMAN OTC DRUG Aveeno Active Naturals Skin Relief Medicated Anti Itch Treatment Pramoxine Hydrochloride CREAM TOPICAL 20110907 20170701 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. PRAMOXINE HYDROCHLORIDE 5 mg/g 58232-0037_0f5f6cf2-2d30-40c1-9338-f1fb2663d2eb 58232-0037 HUMAN OTC DRUG Aveeno Active Naturals Hydrosport Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20120524 20150601 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 40; 80; 50 mg/g; mg/g; mg/g; mg/g; mg/g 58232-0038_bac5665f-ca69-4e1d-9bd1-5a01fef26bc0 58232-0038 HUMAN OTC DRUG Aveeno Active Naturals Skin Relief Moisturizing Dimethicone LOTION TOPICAL 20110920 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIMETHICONE 13 mg/mL 58232-0039_a7210f1b-7e9b-4701-89ad-519e096f19b2 58232-0039 HUMAN OTC DRUG Aveeno Active Naturals Skin Relief Overnight Dimethicone CREAM TOPICAL 20110922 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIMETHICONE 13 mg/g 58232-0040_eb91a605-b2db-4287-b1a6-81eed66012d7 58232-0040 HUMAN OTC DRUG Aveeno Active Naturals Natural Protection Broad Spectrum SPF30 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120110 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. TITANIUM DIOXIDE; ZINC OXIDE 43; 30 mg/g; mg/g 58232-0041_9b29017a-1892-48f4-8d09-8a96e3de0e80 58232-0041 HUMAN OTC DRUG Korres Wild Rose Mineral Foundation SPF 30 - Fair Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20110501 20170801 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. TITANIUM DIOXIDE; ZINC OXIDE 16; 15 mg/g; mg/g 58232-0042_6bb961c8-4863-4a82-8ae3-1a3643a291bb 58232-0042 HUMAN OTC DRUG Korres Wild Rose Mineral Foundation SPF 30 - Fairly Light Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20110501 20170801 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. TITANIUM DIOXIDE; ZINC OXIDE 16; 15 mg/g; mg/g 58232-0043_66412d6b-1901-439d-860f-f5b768928a93 58232-0043 HUMAN OTC DRUG Korres Wild Rose Mineral Foundation SPF 30 - Medium Beige Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20110501 20170801 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. TITANIUM DIOXIDE; ZINC OXIDE 16; 15 mg/g; mg/g 58232-0044_a1a4c11a-5356-451e-bcd4-f2c261af8ca1 58232-0044 HUMAN OTC DRUG Korres Wild Rose Mineral Foundation SPF 30 - Medium Tan Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20110501 20170801 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. TITANIUM DIOXIDE; ZINC OXIDE 16; 15 mg/g; mg/g 58232-0048_37ec2edc-4dad-43f6-8b01-3d60d3b67d20 58232-0048 HUMAN OTC DRUG Aveeno Active Naturals Eczema Therapy Hand Oatmeal CREAM TOPICAL 20140501 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. OATMEAL 10 mg/g 58232-0049_a8009e7a-a8c8-4341-97f2-88f545e98bfa 58232-0049 HUMAN OTC DRUG Neosporin Eczema Essentials Daily Moisturizing Oatmeal CREAM TOPICAL 20111115 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. OATMEAL 10 mg/g 58232-0050_2a26b836-8313-472b-9af2-165b69fa9f65 58232-0050 HUMAN OTC DRUG Aveeno Active Naturals Positively Ageless Correcting Tinted Moisturizer Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20120909 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; meq/mL; mg/mL 58232-0051_9e75c6d8-c63f-46da-a00d-91f871bea147 58232-0051 HUMAN OTC DRUG Clean and Clear Advantage Daily Soothing Acne Wash Salicylic Acid LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/mL 58232-0054_ee31f831-7dd5-4c2a-bf33-f237e08aceac 58232-0054 HUMAN OTC DRUG Clean and Clear Advantage Acne Cleanser Salicylic Acid LIQUID TOPICAL 20120206 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/mL 58232-0056_e5f99c09-e2c5-4726-8ed2-6d35b3eeada5 58232-0056 HUMAN OTC DRUG Aveeno Active Naturals Positively Ageless Correcting Tinted Moisturizer SPF30 Light to Medium Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20110929 20160901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL 58232-0059_2689ce83-5264-4314-8108-a8d58a3f8940 58232-0059 HUMAN OTC DRUG Clean and Clear Essentials Dual Action Moisturizer Salicylic Acid LOTION TOPICAL 20130624 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 5 mg/mL 58232-0062_60208b99-5979-4352-b5b6-ed6e37b4d67e 58232-0062 HUMAN OTC DRUG Clean and Clear Advantage Daily Soothing Acne Scrub Salicylic Acid CREAM TOPICAL 20120919 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/g 58232-0063_17d41a1d-f32c-4df8-b378-361f847afbda 58232-0063 HUMAN OTC DRUG Clean and Clear Advantage Acne Control 3 in 1 Foaming Wash Salicylic Acid LIQUID TOPICAL 20131013 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/mL 58232-0065_6446d359-b7cf-4f34-b44a-2d27a46a8305 58232-0065 HUMAN OTC DRUG Aveeno Baby Organic Harvest Diaper Rash Zinc Oxide CREAM TOPICAL 20110929 20170901 OTC MONOGRAPH NOT FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. ZINC OXIDE 130 mg/g 58232-0066_804659b5-dd55-43ea-a759-db5e567b38b7 58232-0066 HUMAN OTC DRUG Aveeno Active Naturals Nourish Plus Dandruff Control Anti Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20121010 OTC MONOGRAPH FINAL part358H Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. PYRITHIONE ZINC 10.2 mg/mL 58232-0067_37020e23-4d97-42ee-a9ec-a7474d60e8fb 58232-0067 HUMAN OTC DRUG Aveeno Active Naturals Nourish Plus Dandruff Control Anti Dandruff 2 in 1 Shampoo and Conditioner Pyrithione Zinc LIQUID TOPICAL 20121010 OTC MONOGRAPH FINAL part358H Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. PYRITHIONE ZINC 10.2 mg/mL 58232-0069_d7b4a086-f966-4e71-9310-75d61b4ecd42 58232-0069 HUMAN OTC DRUG Aveeno Active Naturals Nourish Plus Dandruff Control Anti Dandruff Conditioner Pyrithione Zinc LIQUID TOPICAL 20121010 OTC MONOGRAPH FINAL part358H Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. PYRITHIONE ZINC 4.9 mg/mL 58232-0104_d3ef88b5-8f1e-45bd-be70-74b8930e0dec 58232-0104 HUMAN OTC DRUG Aveeno Baby Daily Moisture Dimethicone LOTION TOPICAL 20101201 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIMETHICONE 12 mg/mL 58232-0205_fbb4ba30-ed34-4915-81d1-5fdc4c900fa4 58232-0205 HUMAN OTC DRUG Aveeno Active Naturals Positively Radiant Daily Moisturizer SPF 15 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20110310 20160715 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 29.7; 75.6; 20.2 mg/mL; mg/mL; mg/mL 58232-0208_4d075cd6-c567-403b-a138-740204bb9ddc 58232-0208 HUMAN OTC DRUG Aveeno Clear Complexion Daily Moisturizer Salicylic Acid LOTION TOPICAL 20110707 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 5 mg/mL 58232-0210_b6d96d20-9eb6-4b1f-a1e1-55f31e8cb60d 58232-0210 HUMAN OTC DRUG Aveeno Clear Complexion Foaming Cleanser Salicylic Acid LIQUID TOPICAL 20110823 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 5 mg/mL 58232-0211_ce10b627-5a24-4f1a-afba-8f2792f6de96 58232-0211 HUMAN OTC DRUG Aveeno Baby Calming Comfort Dimethicone LOTION TOPICAL 20110809 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIMETHICONE 12 mg/mL 58232-0212_fe32e7c1-3348-4453-ad49-25d27143c386 58232-0212 HUMAN OTC DRUG Johnsons No More Rash Diaper Rash 3 in 1 Formula Zinc Oxide CREAM TOPICAL 20120427 OTC MONOGRAPH NOT FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. ZINC OXIDE 130 mg/g 58232-0218_8aeaa480-7d5b-468a-8120-40842a1a61fb 58232-0218 HUMAN OTC DRUG Clean and Clear Continuous Control Acne Cleanser Benzoyl Peroxide CREAM TOPICAL 20100120 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BENZOYL PEROXIDE 100 mg/g 58232-0225_f2b2bdeb-d13f-4e6b-881d-31fee7eb9a37 58232-0225 HUMAN OTC DRUG RoC Brilliance Day Rejuvenating SPF20 Avobenzone, Homosalate, and Octocrylene LOTION TOPICAL 20100305 20170101 OTC MONOGRAPH FINAL part352 Johnson & Johnson Consumer Products Co., Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTOCRYLENE 25; 80; 25 mg/mL; mg/mL; mg/mL 58232-0303_645f987a-822a-407c-a3f7-a3ecdc2a9542 58232-0303 HUMAN OTC DRUG Aveeno Clear Complexion Cleansing Bar Salicylic Acid SOAP TOPICAL 20130612 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 5 mg/g 58232-0316_1e1bcb1a-566d-4586-8fe5-9bac883e26e2 58232-0316 HUMAN OTC DRUG Clean and Clear Advantage Acne Spot Treatment Salicylic Acid LOTION TOPICAL 20120504 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/mL 58232-0317_3ab84570-a801-4446-9991-946561bd7b21 58232-0317 HUMAN OTC DRUG Clean and Clear Morning Glow Moisturizer Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20121004 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL 58232-0318_e4731a80-d4cc-44e6-b097-007da257488f 58232-0318 HUMAN OTC DRUG Clean and Clear Advantage 3-in-1 Exfoliating Cleanser Benzoyl Peroxide LIQUID TOPICAL 20100301 20160201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Conosumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BENZOYL PEROXIDE 5.57 mg/g 58232-0327_0e214588-029d-4cee-acda-df5ccce042cc 58232-0327 HUMAN OTC DRUG Clean and Clear Advantage Mark Treatment Salicylic Acid LOTION TOPICAL 20131023 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/mL 58232-0329_c75e4eb1-8856-4f1e-801a-57e8f7d92360 58232-0329 HUMAN OTC DRUG Clean and Clear Blackhead Eraser Cleansing Mask Salicylic Acid CREAM TOPICAL 20110623 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 5 mg/g 58232-0333_8a8abf78-6e5f-4db1-b8ec-3d0877ed09e0 58232-0333 HUMAN OTC DRUG Clean and Clear Finishes Pore Perfecting Moisturizer Avobenzone, Octisalate, Oxybenzone and Octocrylene LOTION TOPICAL 20091115 20161101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Co., Division of Johnson & Johnson Consumer Companies, inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 50; 17; 30 mg/g; mg/g; mg/g; mg/g 58232-0406_d985191b-930f-4a5b-b260-a9c195db5dd7 58232-0406 HUMAN OTC DRUG Cortaid Maximum Strength Hydrocortisone Acetate OINTMENT TOPICAL 20091030 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson consumer Companies, Inc. HYDROCORTISONE ACETATE 1 g/100g 58232-0410_7499a22f-7fad-4d45-b30b-03e74360d646 58232-0410 HUMAN OTC DRUG Aveeno Clear Complexion Daily Cleansing Salicylic Acid CLOTH TOPICAL 20130519 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 5 mg/1 58232-0411_f186056d-9335-49d6-99dd-d892c5a59836 58232-0411 HUMAN OTC DRUG Clean and Clear Sensitive Skin Salicylic Acid LIQUID TOPICAL 20110707 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 5 mg/mL 58232-0412_d4c485f6-f0d5-4802-9988-2e87fab81d49 58232-0412 HUMAN OTC DRUG Clean and Clear Deep Cleaning Salicylic Acid LIQUID TOPICAL 20110627 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/mL 58232-0423_cbc686cb-c114-4fc2-991e-6622b8681beb 58232-0423 HUMAN OTC DRUG Neosporin Original Bacitracin, Neomycin, Polymyxin B KIT 20110804 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. 58232-0424_049ba971-6efb-428a-a671-466b151a6a44 58232-0424 HUMAN OTC DRUG Neosporin Original Bacitracin, Neomycin, Polymyxin B KIT 20110829 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. 58232-0501_9998c7f0-5636-4250-a926-b570e5a5c3f7 58232-0501 HUMAN OTC DRUG Aveeno Active Naturals Essential Moisture Lip Conditioner Dimethicone STICK TOPICAL 20120727 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIMETHICONE 10 mg/g 58232-0504_f8b04f0a-39f9-4e0d-a2bf-2cd6b0500fcf 58232-0504 HUMAN OTC DRUG Ambi Essentials Avobenzone, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20100128 20150131 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Co., Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 50; 17; 30 mg/59mL; mg/59mL; mg/59mL; mg/59mL 58232-0512_edbf98d1-cfa7-49f1-8190-c87daa14ecfe 58232-0512 HUMAN OTC DRUG Aveeno Ultra-Calming Daily Moisturizer SPF 30 Homosalate, Octinoxate, Octisalate and Titanium Dioxide LOTION TOPICAL 20090825 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 51.3; 76.9; 51.3; 24.6 mg/mL; mg/mL; mg/mL; mg/mL 58232-0514_ef5ba227-ba5c-48de-92c1-e03981099ffc 58232-0514 HUMAN OTC DRUG Aveeno Ultra-Calming Daily Moisturizer SPF15 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20110809 20150601 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL 58232-0517_328223fc-a0c4-4d6b-8ce8-8f12b8b93582 58232-0517 HUMAN OTC DRUG Aveeno Continuous Protection SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20110822 20171201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 24; 50 mg/g; mg/g; mg/g; mg/g; ug/g 58232-0524_f84a8ab8-a95d-455b-9786-b7a4cd181263 58232-0524 HUMAN OTC DRUG Aveeno Active Naturals Skin Relief Moisturizing Fragrance Free Dimethicone LOTION TOPICAL 20110808 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIMETHICONE 13 mg/mL 58232-0526_e5243e58-138b-49f2-b221-f92252d03537 58232-0526 HUMAN OTC DRUG Aveeno Eczema Therapy Bath Treatment Oatmeal POWDER TOPICAL 20120222 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. OATMEAL 1000 mg/g 58232-0527_6aa2b816-1978-4db9-b4af-3edaa82ec410 58232-0527 HUMAN OTC DRUG Aveeno Active Naturals Eczema Therapy Care oatmeal KIT 20120222 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. 58232-0528_4d99bb1b-f6d4-4a65-9d0d-974b69fc7917 58232-0528 HUMAN OTC DRUG Aveeno Eczema Therapy Moisturizing Oatmeal CREAM TOPICAL 20120222 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. OATMEAL 10 mg/g 58232-0529_689ad8c9-8532-4dae-b963-6d40cacdfa90 58232-0529 HUMAN OTC DRUG Aveeno Active Naturals Positively Radiant Daily Moisturizer Sunscreen Broad Spectrum SPF15 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20120709 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL 58232-0531_0308563a-df01-4fc2-a1f3-d0cea1379579 58232-0531 HUMAN OTC DRUG Aveeno Baby Natural Protection Face Sunscreen Broad Spectrum SPF50 Titanium Dioxide and Zinc Oxide STICK TOPICAL 20121018 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. TITANIUM DIOXIDE; ZINC OXIDE 80.9; 68 mg/g; mg/g 58232-0532_1be3b054-36a0-40e2-b10f-07a08ab095da 58232-0532 HUMAN OTC DRUG Aveeno Positively Ageless Complete Anti Aging System Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone KIT 20121129 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. 58232-0533_bd08c651-a683-43f4-9e9f-4dc0f5c56d5a 58232-0533 HUMAN OTC DRUG Aveeno Skin Relief 24hr Moisturizing Fragrance Free Dimethicone LOTION TOPICAL 20140313 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIMETHICONE 12 mg/mL 58232-0603_33af021b-7c86-48b1-89fa-de01aa634a2d 58232-0603 HUMAN OTC DRUG Aveeno Active Naturals Positively Radiant Daily Moisturizer Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120824 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58232-0606_ab750c0f-b2cd-4e1d-9b52-b277ed096626 58232-0606 HUMAN OTC DRUG Ambi Even and Clear Daily Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120724 20151003 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58232-0626_eb62c63f-85b4-4f2e-8c96-974668b8045c 58232-0626 HUMAN OTC DRUG Aveeno Baby Continuous Protection Sunscreen Broad Spectrum SPF55 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120628 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58232-0631_36ad334d-eb8b-49d6-a110-1e222bda74d9 58232-0631 HUMAN OTC DRUG Aveeno Baby Soothing Relief Diaper Rash Fragrance Free Zinc Oxide CREAM TOPICAL 20110817 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. ZINC OXIDE 130 mg/g 58232-0632_705945fb-e217-456d-996e-d8dddd88fe8a 58232-0632 HUMAN OTC DRUG Clean and Clear Advantage Acne Control Moisturizer Salicylic Acid LOTION TOPICAL 20110804 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 5 mg/mL 58232-0633_e9e6bf61-c5df-4d3e-a9a4-bc28120bd62a 58232-0633 HUMAN OTC DRUG Clean and Clear Advantage Acne Control Benzoyl Peroxide, Salicylic Acid KIT 20120509 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. 58232-0635_eb27e9f8-81b5-4b18-af65-6c464f3796dd 58232-0635 HUMAN OTC DRUG Aveeno Positively Ageless SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100104 20150401 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 28; 60 mg/g; mg/g; mg/g; mg/g; mg/g 58232-0636_378e9f7a-2768-48d0-ba75-276231f4affd 58232-0636 HUMAN OTC DRUG Aveeno Active Naturals Clear Complexion BB Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL 58232-0637_0f5f6cf2-2d30-40c1-9338-f1fb2663d2eb 58232-0637 HUMAN OTC DRUG Aveeno Active Naturals Hydrosport Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20120524 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 40; 80; 50 mg/g; mg/g; mg/g; mg/g; mg/g 58232-0638_7b6087d1-5ea3-4e07-8c91-8b1f8f5d3cd1 58232-0638 HUMAN OTC DRUG Aveeno Active Naturals Ultra Calming Daily Moisturizer Sunscreen Broad Spectrum SPF15 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20120531 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL 58232-0639_eaf73651-ab45-4b3c-8033-4c89d20a218e 58232-0639 HUMAN OTC DRUG Aveeno Active Naturals Positively Radiant Tinted Moisturizer - Fair to Light Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20121004 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL 58232-0640_cf60c4a8-6a60-45af-a8ee-8a8c67566324 58232-0640 HUMAN OTC DRUG Aveeno Active Naturals Positively Radiant Tinted Moisturizer - Medium Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20121004 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL 58232-0641_02a99c2a-c97f-4857-8ae2-15bc14cba795 58232-0641 HUMAN OTC DRUG Aveeno Active Naturals Clear Complexion BB Broad Spectrum SPF30 - Medium Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL 58232-0645_473261b9-c592-4116-b8cc-81693296f85f 58232-0645 HUMAN OTC DRUG Aveeno Continuous Protection SPF85 Avobenzone, Homosalate, Octocrylene, Oxybenzone and Octisalate LOTION TOPICAL 20100104 20161201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 58232-0646_a0eab788-04d4-429e-b880-3f1f53bbc26c 58232-0646 HUMAN OTC DRUG Aveeno Continuous Protection Face SPF100 Plus Avobenzone, Homosalate, Octocrylene, Oxybenzone and Octisalate LOTION TOPICAL 20100104 20161201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 58232-0649_a16112c4-9b69-4710-a995-13a6bb92e84e 58232-0649 HUMAN OTC DRUG Aveeno Positively Ageless SPF55 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100104 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 28; 60 mg/g; mg/g; mg/g; mg/g; mg/g 58232-0653_4e3890b5-6d98-4787-9e7b-0c1dfa59ad1a 58232-0653 HUMAN OTC DRUG Aveeno Active Naturals Positively Radiant Tinted Moisturizer SPF 30 Fair/Light Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20100315 20151004 OTC MONOGRAPH FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL 58232-0654_73a0b172-6c09-4706-8516-0c823b179b82 58232-0654 HUMAN OTC DRUG Aveeno Positively Ageless Face SPF90 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100104 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 58232-0702_b060a39f-c9d7-4097-ab74-af40adafa7c7 58232-0702 HUMAN OTC DRUG Aveeno Clear Complexion Cleanser Salicylic Acid CREAM TOPICAL 20130620 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/g 58232-0711_d7bbe477-d105-4092-959d-8e528fb7f0c2 58232-0711 HUMAN OTC DRUG Neosporin Plus Pain Relief Neo To Go First Aid Antiseptic Pain Relieving BENZALKONIUM CHLORIDE AND PRAMOXINE HYDROCHLORIDE SPRAY TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BENZALKONIUM CHLORIDE; PRAMOXINE HYDROCHLORIDE 1.3; 10 mg/mL; mg/mL 58232-0716_551dd220-5e09-49f5-acc2-707aa9f2d514 58232-0716 HUMAN OTC DRUG Aveeno Daily Moisturizing SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20110812 20150401 OTC MONOGRAPH FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL 58232-0718_de9d9c0f-1f8a-4661-a829-052889dd8894 58232-0718 HUMAN OTC DRUG Lubriderm Daily Moisturizer with Sunscreen SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100601 20150601 OTC MONOGRAPH FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 40; 30; 22 mg/mL; mg/mL; mg/mL; mg/mL 58232-0720_b3291d42-9393-43cd-a20d-bbc0883568ff 58232-0720 HUMAN OTC DRUG Desitin Rapid Relief Creamy Diaper Rash Zinc Oxide CREAM TOPICAL 20110515 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. ZINC OXIDE 130 mg/g 58232-0721_cf71448c-1af8-4194-bd34-a7747f20c0f8 58232-0721 HUMAN OTC DRUG Desitin Maximum Strength Original Zinc Oxide OINTMENT TOPICAL 20110908 OTC MONOGRAPH NOT FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. ZINC OXIDE 400 mg/g 58232-0722_444ff909-43b6-4514-bc02-213d1a7a6d70 58232-0722 HUMAN OTC DRUG Desitin Multi-Purpose Fragrance Free Petrolatum OINTMENT TOPICAL 20101101 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. PETROLATUM 703.2 mg/g 58232-0723_0a994885-a084-444d-b9d8-1b65c9e0863a 58232-0723 HUMAN OTC DRUG Desitin Rapid Relief Creamy Fragrance Free Zinc Oxide CREAM TOPICAL 20130715 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. ZINC OXIDE 130 mg/g 58232-0730_eb8af3db-7ebc-48de-aa00-1caabf0df5ac 58232-0730 HUMAN OTC DRUG Caladryl Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride LOTION TOPICAL 20120217 20150601 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 1.36; 10; 78.65 mg/mL; mg/mL; mg/mL 58232-0731_b4b4017d-e6d1-4c3d-bcc5-b0292365d4b5 58232-0731 HUMAN OTC DRUG Caladryl Clear PRAMOXINE HYDROCHLORIDE and ZINC ACETATE LOTION TOPICAL 20120217 20150501 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL 58232-0740_b38a5e58-ed73-47e8-bbb1-176de84d2098 58232-0740 HUMAN OTC DRUG Benadryl Original Strength Itch Stopping Diphenhydramine Hydrochloride and Zinc Acetate CREAM TOPICAL 20121015 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/g; mg/g 58232-0741_4f60bcab-6105-43e5-bfe1-b8db426f06a8 58232-0741 HUMAN OTC DRUG Benadryl Extra Strength Itch Stopping Diphenhydramine Hydrochloride and Zinc Acetate CREAM TOPICAL 20121015 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; 1 mg/g; mg/g 58232-0742_52cc33f1-de57-44db-a30a-1711eefd6e5d 58232-0742 HUMAN OTC DRUG Benadryl Extra Strength Itch Relief Diphenhydramine Hydrochloride and Zinc Acetate SOLUTION TOPICAL 20130612 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/mL; mg/mL 58232-0744_e39a3532-5146-4b44-98f1-e28c6d1cc0ad 58232-0744 HUMAN OTC DRUG Benadryl Extra Strength Itch Stopping Diphenhydramine Hydrochloride GEL TOPICAL 20130213 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/mL 58232-0745_b75db2dd-6b67-4bca-a894-ffb225664e67 58232-0745 HUMAN OTC DRUG Benadryl ReadyMist Itch Stopping Diphenhydramine Hydrochloride and Zinc Acetate SPRAY TOPICAL 20141006 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/mL; mg/mL 58232-0747_f7a80ad2-3bd6-4c4d-a456-0901602958e2 58232-0747 HUMAN OTC DRUG Childrens Benadryl Itch Cooling CAMPHOR (SYNTHETIC) GEL TOPICAL 20120427 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. CAMPHOR (SYNTHETIC) 4.5 mg/g 58232-0748_c06fdde9-9a90-489a-b32d-9fbcb0d599a0 58232-0748 HUMAN OTC DRUG LUBRIDERM Avobenzone, Homosalate, Octisalate, Oxybenzone and Octocrylene LOTION TOPICAL 20100330 20160701 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 60; 50; 35.5; 50 mg/g; mg/g; mg/g; mg/g; mg/g 58232-0749_19ff56f0-eb2f-49a3-9494-919efecee639 58232-0749 HUMAN OTC DRUG Lubriderm Intense Skin Repair Glycerin OINTMENT TOPICAL 20110131 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. GLYCERIN 40 mg/g 58232-0750_eb6ead4f-1f24-46d6-8464-6de1ea7bef1b 58232-0750 HUMAN OTC DRUG BENADRYL Extra Strength Itch Cooling Diphenhydramine Hydrochloride and Zinc Acetate SPRAY TOPICAL 20120322 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/mL; mg/mL 58232-0751_04685bd7-783b-4b01-aed2-e4e075fc7767 58232-0751 HUMAN OTC DRUG Childrens Benadryl Itch Cooling CAMPHOR (SYNTHETIC) GEL TOPICAL 20120427 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. CAMPHOR (SYNTHETIC) 4.5 mg/g 58232-0752_9c5fbdb5-0f1a-47ec-bdbc-c689a229b32b 58232-0752 HUMAN OTC DRUG Aveeno Active Naturals Daily Moisturizing Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120503 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL 58232-0753_2642d7fb-a258-49ec-a6ec-c750e76d25d9 58232-0753 HUMAN OTC DRUG Lubriderm Daily Moisture Sunscreen Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120531 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 40; 30; 22 mg/mL; mg/mL; mg/mL; mg/mL 58232-0754_714e34e3-a4da-4cb7-bd7f-ea40322ca55f 58232-0754 HUMAN OTC DRUG Clean and Clear Blackhead Eraser Scrub Salicylic Acid CREAM TOPICAL 20120531 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/g 58232-0755_8b11972d-9831-4035-9b63-47f9e7129029 58232-0755 HUMAN OTC DRUG Aveeno Active Naturals Smart Essentials Daily Nourishing Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58232-0801_4253a5ba-c13e-4b61-8ab5-ba400473f291 58232-0801 HUMAN OTC DRUG Clean and Clear Advantage Oil Absorbing Cleanser Salicylic Acid CREAM TOPICAL 20120412 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 5 mg/g 58232-0802_73e93551-a91f-47bd-9731-8f1607e25c8e 58232-0802 HUMAN OTC DRUG Clean and Clear Advantage Oil Absorbing Treatment Salicylic Acid LOTION TOPICAL 20120412 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/mL 58232-0803_889c5051-d8a6-4958-be6d-4066ea1efdcc 58232-0803 HUMAN OTC DRUG Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20120412 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g 58232-0804_96d429bb-17db-46e3-9677-d43650712add 58232-0804 HUMAN OTC DRUG Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20120413 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 40; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g 58232-0805_c263b5dc-3a69-4f20-b503-58ae0ea86981 58232-0805 HUMAN OTC DRUG Aveeno Baby Natural Protection Sunscreen Broad Spectrum SPF 50 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120413 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/g; mg/g 58232-0806_b2899046-2e0f-469c-afba-b49306cb7718 58232-0806 HUMAN OTC DRUG Aveeno Natural Protection Sunscreen Broad Spectrum SPF 50 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120413 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/g; mg/g 58232-0807_f83af5b5-9a5f-4cf0-a21f-f153692091b6 58232-0807 HUMAN OTC DRUG Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum SPF50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20120412 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 60; 50 mg/g; mg/g; mg/g; mg/g; mg/g 58232-0809_3fdb8399-6b11-40ae-a14e-495983959805 58232-0809 HUMAN OTC DRUG Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum SPF50 For Face Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20140318 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 60; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58232-1402_d79a9079-43e7-4af0-9cdb-8c3e02071d01 58232-1402 HUMAN OTC DRUG Aveeno Hydrocortisone Anti Itch Hydrocortisone CREAM TOPICAL 20121008 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. HYDROCORTISONE 10 mg/g 58232-1403_ea13a83a-ea85-49dd-a94b-e5611b8e2a99 58232-1403 HUMAN OTC DRUG Aveeno Eczema Therapy Moisturizing Oatmeal CREAM TOPICAL 20110629 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. OATMEAL 10 mg/g 58232-1404_b2d41ad7-7b7f-4e52-b557-11400413fd50 58232-1404 HUMAN OTC DRUG Aveeno Baby Eczema Therapy Moisturizing Oatmeal CREAM TOPICAL 20110629 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. OATMEAL 10.3 mg/g 58232-1405_2efa45ee-9bd7-4315-9d5a-a5f2d0edd7fb 58232-1405 HUMAN OTC DRUG Aveeno Baby Eczema Therapy Oatmeal CREAM TOPICAL 20100818 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. OATMEAL 10.3 mg/g 58232-1406_522133d9-dd73-4dba-9021-4c1a9e9ae997 58232-1406 HUMAN OTC DRUG Bengay Greaseless Pain Relieving Menthol and Methyl Salicylate CREAM TOPICAL 20131215 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. MENTHOL; METHYL SALICYLATE 10; 15 mg/g; mg/g 58232-4001_fc8382e0-bb17-4469-9ab5-f98b71e2ae63 58232-4001 HUMAN OTC DRUG Neosporin Plus Pain Relief First Aid Antibiotic/Pain Relieving Neomycin, Polymyxin B, and Pramoxine Hydrochloride CREAM TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. NEOMYCIN; POLYMYXIN B; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 58232-4002_e2c130fd-fa40-41ba-bd99-2eac2656315c 58232-4002 HUMAN OTC DRUG Neosporin Original Bacitracin, Neomycin, and Polymyxin B OINTMENT TOPICAL 20110803 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BACITRACIN; NEOMYCIN; POLYMYXIN B 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 58232-4003_39f0bf68-234f-4ce3-bb8f-26068c60a1c5 58232-4003 HUMAN OTC DRUG Neosporin Plus Pain Relief Maximum Strength First Aid Antibiotic Pain Relieving Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20130714 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 58232-4009_457c6b60-6894-485b-90c1-b06567bf6433 58232-4009 HUMAN OTC DRUG Neosporin Plus Pain Relief Neo To Go First Aid Antiseptic Pain Relieving For Kids Benzalkonium Chloride and Pramoxine Hydrochloride SPRAY TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BENZALKONIUM CHLORIDE; PRAMOXINE HYDROCHLORIDE 1.3; 10 mg/mL; mg/mL 58232-4010_477e2e9a-d6c4-4e0d-9799-41b3a54af2b9 58232-4010 HUMAN OTC DRUG Neosporin Eczema Essentials Anti Itch Hydrocortisone CREAM TOPICAL 20110930 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. HYDROCORTISONE 10 mg/g 58232-4011_7d8ea921-8c8d-4f2e-b553-9a6bfd53d394 58232-4011 HUMAN OTC DRUG Neosporin Essentials Trial Pack Colloidal Oatmeal and Hydrocortisone KIT 20111024 NDA NDA017450 Johnson & Johnson Consumer Products company, Division of Johnson & Johnson Consumer Companies, Inc. 58232-4013_78109033-1ce5-45c6-be2a-1a59c048505a 58232-4013 HUMAN OTC DRUG Neosporin Plus Pain Relief First Aid Antibiotic Pain Relieving For Kids Neomycin, Polymyxin B, and Pramoxine Hydrochloride CREAM TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. NEOMYCIN; POLYMYXIN B; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 58232-4015_2d4a3cde-dd3f-4a1c-a870-ca39fb18b3cb 58232-4015 HUMAN OTC DRUG BENGAY Pain Relief and Massage Menthol GEL TOPICAL 20091231 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson Consumer Companies, Inc. MENTHOL 2.5 g/100g 58232-4016_6ad4a469-868f-4a98-b6d6-8381bac481ce 58232-4016 HUMAN OTC DRUG BenGay Vanishing Scent Menthol GEL TOPICAL 20091130 OTC MONOGRAPH FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. MENTHOL 2.5 g/100g 58232-4018_4f12deb5-b427-4348-9430-62bb27f3badf 58232-4018 HUMAN OTC DRUG Neosporin Wound Cleanser Benzalkonium Chloride LIQUID TOPICAL 20110622 OTC MONOGRAPH NOT FINAL part333A Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL 58232-4020_e0f67873-e7de-4756-9a95-9ddecac02eeb 58232-4020 HUMAN OTC DRUG Bengay Arthritis Pain Relieving Menthol and Methyl Salicylate CREAM TOPICAL 20120523 20170801 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. MENTHOL; METHYL SALICYLATE 80; 300 mg/g; mg/g 58232-4021_76cace77-e1df-4a65-b179-de58e3a25485 58232-4021 HUMAN OTC DRUG Bengay Pain Relieving Greaseless Menthol and Methyl Salicylate CREAM TOPICAL 20110707 20160101 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. MENTHOL; METHYL SALICYLATE 100; 150 mg/g; mg/g 58232-4024_a733231d-e0b5-4163-a811-5091f8627848 58232-4024 HUMAN OTC DRUG Bengay Ultra Strength Pain Relieving Camphor (Synthetic), Menthol, and Methyl Salicylate CREAM TOPICAL 20120807 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g 58232-4025_7bb9e97d-efa7-49ae-85f3-56ad6c6a2854 58232-4025 HUMAN OTC DRUG Bengay Ultra Strength Pain Relieving Large Size Menthol PATCH TOPICAL 20110922 20160901 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. MENTHOL 50 mg/1 58232-4026_56eba23a-0261-4eb9-821c-2ec661f0caca 58232-4026 HUMAN OTC DRUG Bengay Ultra Strength Pain Relieving Regular Size Menthol PATCH TOPICAL 20110922 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. MENTHOL 50 mg/1 58232-4029_0d3142d1-e55b-41c2-8701-1913f287ba4f 58232-4029 HUMAN OTC DRUG Bengay Cold Therapy With PRO-COOL technology Menthol GEL TOPICAL 20101025 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products company, Division of Johnson & Johnson Consumer Companies, Inc. MENTHOL 50 mg/g 58232-4033_20f2bbe4-38a2-48f5-a211-abbc2c9176fa 58232-4033 HUMAN OTC DRUG Polysporin Polymyxin B Sulfate and Bacitracin Zinc POWDER TOPICAL 20100614 OTC MONOGRAPH FINAL part333 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g 58232-4034_c62272c6-070f-4742-ac90-63bba66b3826 58232-4034 HUMAN OTC DRUG Polysporin First Aid Antibiotic Bacitracin and polymyxin B sulfate OINTMENT TOPICAL 20130709 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BACITRACIN; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g 58232-4035_1f582558-3fd2-4ef3-ab39-b8a3f08d8fc7 58232-4035 HUMAN OTC DRUG Neosporin Lip Health Overnight Renewal Therapy Petrolatum OINTMENT TOPICAL 20110603 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. PETROLATUM 774 mg/g 58232-4036_0900d53d-cab6-4b49-b58a-59675a69a824 58232-4036 HUMAN OTC DRUG Bengay Zero Degrees Menthol Pain Relieving Menthol CREAM TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. MENTHOL 50 mg/g 58232-5511_abaee20e-f84d-43b9-93d2-0323c9aaa2a9 58232-5511 HUMAN OTC DRUG Aveeno Active Naturals Positively Ageless Multidefense Daily Moisturizer SPF 42 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100820 20150701 OTC MONOGRAPH FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 23.5; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58232-6000_b6c7b8e7-6bc9-45ef-adfe-28f81e7e9354 58232-6000 HUMAN OTC DRUG Bengay Ultra Strength Regular Size Menthol PATCH TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. MENTHOL 50 mg/1 58232-6001_f1b8acc8-71f3-47b4-a864-605fc2254e09 58232-6001 HUMAN OTC DRUG Bengay Ultra Strength Large Size Menthol PATCH TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part348 JJohnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. MENTHOL 50 mg/1 58232-6002_de19e691-e1ee-4d01-9a21-c4f7ccf4ae6b 58232-6002 HUMAN OTC DRUG Aveeno Active Naturals Skin Relief Healing Advanced Therapy Petrolatum OINTMENT TOPICAL 20120430 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. PETROLATUM 540 mg/g 58232-6003_50ef86e5-7e72-40a7-94fc-5aa292334534 58232-6003 HUMAN OTC DRUG Clean and Clear Essentials Deep Cleaning Toner Sensitive Skin Salicylic Acid LIQUID TOPICAL 20120427 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 5 mg/mL 58232-6004_c4f7412b-2cf5-404f-bebf-5563ff2bae8e 58232-6004 HUMAN OTC DRUG Clean and Clear Essentials Deep Cleaning Astringent Salicylic Acid LIQUID TOPICAL 20120430 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/mL 58232-6036_94e09786-1a33-4311-9f57-7bca59b8c0e2 58232-6036 HUMAN OTC DRUG Aveeno Active Naturals Positively Ageless Youth Perfecting Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120524 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58232-9201_09e398e8-2508-45ba-a2ec-cce36be180e8 58232-9201 HUMAN OTC DRUG Johnsons Baby Pure Cornstarch Medicated Zinc Oxide POWDER TOPICAL 20140204 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. ZINC OXIDE 100 mg/g 58232-9202_cb9415d4-48e3-4170-8ccb-7153f5e1ae7a 58232-9202 HUMAN OTC DRUG Johnsons Baby Intense Moisture Dimethicone CREAM TOPICAL 20130103 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIMETHICONE 20 mg/g 58232-9204_e2601fce-6769-4e85-a1bb-40f8e1d59759 58232-9204 HUMAN OTC DRUG Baby Daily Face and Body Titanium dioxide and Zinc Oxide LOTION TOPICAL 20091115 20150901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Co., Division of Johnson & Johnson Consumer Companies, inc. TITANIUM DIOXIDE; ZINC OXIDE 121.7; 50 mg/mL; mg/mL 58232-9612_612f95b7-45f7-4f6c-b914-715ffaaa7602 58232-9612 HUMAN OTC DRUG Neosporin Plus Pain Relief Neo to Go Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20110201 20181001 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g 58232-9809_993483e4-b39b-4886-9e03-d11ad84bebfd 58232-9809 HUMAN OTC DRUG Purpose Octinoxate, Octisalate and Oxybenzone LOTION TOPICAL 20091101 20160801 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 76; 50; 30 mg/mL; mg/mL; mg/mL 58232-9814_640bf9c7-d9da-48c0-a1eb-e1aba78c92e6 58232-9814 HUMAN OTC DRUG Clean and Clear Persa-Gel 10 Benzoyl Peroxide GEL TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BENZOYL PEROXIDE 28 mg/mL 58232-9907_d61d7086-1180-4d49-8dd4-65ce6c4519cb 58232-9907 HUMAN OTC DRUG Aveeno Daily Moisturizing Dimethicone LOTION TOPICAL 20100901 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIMETHICONE 12 mg/g 58232-9910_26f2aa3f-cf2a-45c3-8786-acf94d297383 58232-9910 HUMAN OTC DRUG Aveeno Anti Itch Concentrated Zinc Oxide, Ferric Oxide Red, and Pramoxine Hydrochloride LOTION TOPICAL 20121107 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE .6; 10; 29.4 mg/mL; mg/mL; mg/mL 58232-9911_62890a4c-5dea-41de-9732-673882b3aa59 58232-9911 HUMAN OTC DRUG Aveeno Calamine and Pramoxine Hydrochloride Anti Itch Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride CREAM TOPICAL 20130620 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE .6; 10; 29.4 mg/g; mg/g; mg/g 58232-9912_9f03efe5-1e7d-4d79-bd5c-eeed99673d06 58232-9912 HUMAN OTC DRUG Aveeno Baby Essential Daily Care Baby and Mommy Gift Set Dimethicone, Avobenzone, Octinoxate, and Octisalate KIT 20121204 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. 58232-9913_991e2b8d-1a03-4880-8c32-b4826d8fac12 58232-9913 HUMAN OTC DRUG RoC Multi Correxion 5 in 1 Perfecting Sunscreen Broad Spectrum SPF 25 Octinoxate, Octisalate, and Titanium Dioxide LOTION TOPICAL 20131203 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 70; 30; 66 mg/mL; mg/mL; mg/mL 58232-9914_99f143dd-b122-4bf6-a8a3-d48300ae0270 58232-9914 HUMAN OTC DRUG Aveeno Baby Mommy and Me Gift Set Zinc Oxide and Dimethicone KIT 20130510 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. 58232-9916_962a76ac-698d-4a44-9d3e-f08cb675e814 58232-9916 HUMAN OTC DRUG Neosporin Plus Pain Relief Neo To Go First Aid Antibiotic Pain Relieving Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20130714 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 58232-9917_415bfbef-16ec-441a-a87a-25cdff65c607 58232-9917 HUMAN OTC DRUG Aveeno Baby Bathtime Baby and Mommy Gift Set Dimethicone KIT 20141112 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. 58238-225_0bda4b78-2647-41f7-8b80-71677fa523af 58238-225 HUMAN OTC DRUG DELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20140227 OTC MONOGRAPH FINAL part341 Deliz Pharmaceutical Corp DEXCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 15; 30 mg/5mL; mg/5mL; mg/5mL 58238-226_7fb89b8c-8879-48ec-98c8-0d7cd56fa7b5 58238-226 HUMAN OTC DRUG DELTUSS DP Nasal Decongestant Antihistamine CHERRY Flavor DEXCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20140227 OTC MONOGRAPH FINAL part341 Deliz Pharmaceutical Corp DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 30 mg/5mL; mg/5mL 58238-227_8ac2aeff-d019-441a-9346-495b5d84734c 58238-227 HUMAN OTC DRUG TRISPEC DMX Cough Suppressant Expectorant CHERRY RASPBERRY Flavor DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20140321 OTC MONOGRAPH FINAL part341 Deliz Pharmaceutical Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 187 mg/5mL; mg/5mL 58238-228_a24cb55d-d62e-47c8-bb4e-6de347c5ef85 58238-228 HUMAN OTC DRUG TRISPEC PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20140321 OTC MONOGRAPH FINAL part341 Deliz Pharmaceutical Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 187; 30 mg/5mL; mg/5mL; mg/5mL 58238-229_3bb010da-0eb9-4a17-9280-2c14fc3bcef2 58238-229 HUMAN OTC DRUG TRISPEC DMX Pediatric Drops Cough Suppressant Expectorant CHERRY RASPBERRY Flavor DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20140227 OTC MONOGRAPH FINAL part341 Deliz Pharmaceutical Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 187 mg/5mL; mg/5mL 58238-230_3d189a42-2f9b-48ad-a07d-70dd517d4a3d 58238-230 HUMAN OTC DRUG TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20140227 OTC MONOGRAPH FINAL part341 Deliz Pharmaceutical Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 187; 30 mg/5mL; mg/5mL; mg/5mL 58247-001_adfcb533-e96f-4b1d-b10e-950cee44127c 58247-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19810101 UNAPPROVED MEDICAL GAS Respitek Inc OXYGEN 99 L/100L 58265-001_7a727f61-6c51-44a0-b30f-6d1a550fcdc1 58265-001 HUMAN OTC DRUG O24 Pain Neutralizer Camphor SPRAY TOPICAL 20071203 OTC MONOGRAPH NOT FINAL part348 O24 Naturals LLC CAMPHOR (NATURAL) 3.1 g/100mL 58265-002_3f68c73c-a187-4825-ab9c-1f33bf67c585 58265-002 HUMAN OTC DRUG SierraSil Pain Relief Camphor SPRAY TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part348 O24 Naturals, LLC CAMPHOR (NATURAL) 3.1 g/100mL 58268-013_7c7427a7-aa33-4103-b8d6-d79a6e70c58c 58268-013 HUMAN OTC DRUG Acnezzol Base Salicylic Acid LOTION TOPICAL 20130110 OTC MONOGRAPH FINAL part333D SOLUTION INTERNATIONAL INC SALICYLIC ACID 1 mg/mL 58274-006_723a366d-c2d7-4d8d-a9b2-2319df8ca4d2 58274-006 HUMAN OTC DRUG Brush on Block Mineral Sunscreen Broad Spectrum SPF 30 Titanium Dioxide 15%, Zinc Oxide 12% CREAM TOPICAL 20130419 OTC MONOGRAPH NOT FINAL part352 SPF Ventures, LLC TITANIUM DIOXIDE; ZINC OXIDE 15; 12 g/100g; g/100g 58276-015_546e67df-7709-4082-a917-3b044293a7b5 58276-015 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19820101 UNAPPROVED MEDICAL GAS McKnight Inc. dba McKnight Medical OXYGEN 99 L/100L 58281-560_4d6083f5-12d9-4c41-ae9e-78f0ba42b17e 58281-560 HUMAN PRESCRIPTION DRUG Lioresal baclofen INJECTION INTRATHECAL 19920617 NDA NDA020075 Medtronic Neuromodulation BACLOFEN .5 mg/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 58281-561_4d6083f5-12d9-4c41-ae9e-78f0ba42b17e 58281-561 HUMAN PRESCRIPTION DRUG Lioresal baclofen INJECTION INTRATHECAL 19920617 NDA NDA020075 Medtronic Neuromodulation BACLOFEN 2 mg/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 58281-562_4d6083f5-12d9-4c41-ae9e-78f0ba42b17e 58281-562 HUMAN PRESCRIPTION DRUG Lioresal baclofen INJECTION INTRATHECAL 19961107 NDA NDA020075 Medtronic Neuromodulation BACLOFEN .05 mg/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 58281-563_4d6083f5-12d9-4c41-ae9e-78f0ba42b17e 58281-563 HUMAN PRESCRIPTION DRUG Lioresal baclofen INJECTION INTRATHECAL 20030508 NDA NDA020075 Medtronic Neuromodulation BACLOFEN 2 mg/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 58291-0001_bdf47d89-486c-48bc-b9d9-e41c62ea9b38 58291-0001 HUMAN OTC DRUG DERM-APPLY GLYCERIN LIQUID TOPICAL 19890101 OTC MONOGRAPH FINAL part334 Snuva, Inc. GLYCERIN 30.78 mL/100mL 58291-0011_bcd68150-02bd-4cc2-9dde-5b3f7962ba00 58291-0011 HUMAN OTC DRUG NA-ZONE SODIUM CHLORIDE LOTION TOPICAL 19890101 OTC MONOGRAPH FINAL part349 Snuva, Inc. SODIUM CHLORIDE .65 mL/100mL 58292-010_39c1b305-bbea-40d8-b1a8-59d04f7c3e5a 58292-010 HUMAN OTC DRUG NARAMIN DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 20140528 OTC MONOGRAPH FINAL part341 National Pharma Industries Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 58301-010_d4115142-a2a6-45c8-b305-b5561dd7e326 58301-010 HUMAN OTC DRUG Colloidal Silver 30 PPM Argentum Met LIQUID ORAL 20090519 UNAPPROVED HOMEOPATHIC MBI Distributing Inc. SILVER 5 [hp_X]/240mL 58301-020_9f72c0fc-d306-4453-a6e2-fc9b94cddc46 58301-020 HUMAN OTC DRUG Silver-Zinc Throat Acontium Nap, Aloe Vera, Argentum Met, Arnica, Arsenicum Alb, Belladonna, Calendula Officinalis, Cinnabaris, Hydrastis, Mentha Pip, Phosphorus, Zincum Sulf SPRAY ORAL 20090519 UNAPPROVED HOMEOPATHIC MBI Distributing Inc. ACONITUM NAPELLUS; ALOE VERA LEAF; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; GOLDENSEAL; MENTHA PIPERITA; MERCURIC SULFIDE; PHOSPHORUS; SILVER; ZINC SULFATE HEPTAHYDRATE 12; 4; 4; 8; 12; 4; 4; 4; 12; 12; 5; 4 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL 58301-181_ca25ffb3-f69c-4d2c-aa94-525ef518df91 58301-181 HUMAN OTC DRUG Burn Aesculus hippocastanum, Aloe socotrina, Arnica montana, Berberis vulgaris, Calendula officinalis, Salicylicum acidum, Zincum metallicum SPRAY TOPICAL 20100901 UNAPPROVED HOMEOPATHIC MBI Distributing Inc. AESCULUS HIPPOCASTANUM FLOWER; ALOE; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; SALICYLIC ACID; ZINC SULFATE HEPTAHYDRATE 4; 4; 4; 4; 4; 2; 3 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL 58310-001_e87b6186-7803-4739-b3f3-5abac6201078 58310-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140211 UNAPPROVED MEDICAL GAS Keeler's Medical Supply, Inc. OXYGEN 99 L/100L 58311-2222_8d69959c-a090-4eeb-9c08-34be8ac57705 58311-2222 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Young Welding Supply, Inc OXYGEN 99 L/100L 58311-4444_c17a0a01-f13d-4595-8e6a-afab73215823 58311-4444 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Young Welding Supply, Inc NITROGEN 99 L/100L 58318-001_f24f73e7-0201-435b-b6c3-c6719826b26e 58318-001 HUMAN OTC DRUG Better Braids Medicated Salicylic Acid SHAMPOO TOPICAL 19930801 OTC MONOGRAPH FINAL part358H Keystone Laboratories SALICYLIC ACID .24 mg/355mL 58318-002_3a988b2a-78e4-4250-bb4a-670403b086e1 58318-002 HUMAN OTC DRUG Ultra Glow Fade with Aloe Vera Hydroquinone, Padimate O CREAM TOPICAL 19640407 OTC MONOGRAPH NOT FINAL part358A Keystone Laboratories HYDROQUINONE; PADIMATE O 1; 1 g/57g; g/57g 58318-003_a1ff198f-2caf-4435-b0cd-ae6f66f83e1e 58318-003 HUMAN OTC DRUG Ultra Glow Fade Hydroquinone CREAM TOPICAL 19640407 OTC MONOGRAPH NOT FINAL part358A Keystone Laboratories HYDROQUINONE 1 g/51g 58331-030_3338719c-6c2d-47bd-b2c5-f5826f68990d 58331-030 HUMAN OTC DRUG Croc Bloc Broad Spectrum SPF 30 FPS Ecran Solaire HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, and Avobenzone LOTION TOPICAL 20130515 OTC MONOGRAPH NOT FINAL part352 Degil Safety Products (1989) Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10.5; 5; 2; 2 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 58331-050_5de648c2-c35f-462c-84e4-27eeba952477 58331-050 HUMAN OTC DRUG Croc Bloc Broad Spectrum SPF 50 FPS Ecran Solaire HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE LOTION TOPICAL 20130515 OTC MONOGRAPH NOT FINAL part352 Degil Safety Products (1989) Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 58350-000_9777bbcb-7ad0-4cf6-9864-026ea343b125 58350-000 HUMAN OTC DRUG Superior Analgesic Superior Analgesic LINIMENT TRANSDERMAL 20091228 OTC MONOGRAPH FINAL part346 Superior Trading Company MENTHOL 3.5 mg/100mL 58356-001_af7ef59b-255e-450a-9cd6-d003054edeac 58356-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Lampton Welding Supply Company, Inc OXYGEN 99 L/100L 58356-002_2db2b86a-eae8-4173-a557-4565cef26186 58356-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Lampton Welding Supply Company, Inc NITROGEN 99 L/100L 58368-001_2ab97b8c-6085-4230-a25e-9219eeab6e04 58368-001 HUMAN OTC DRUG NeoRelief Actaea Spicata Root, Horse Chestnut, ALTHAEA OFFICINALIS ROOT, ARNICA MONTANA, ATROPA BELLADONNA ROOT, BELLIS PERENNIS, BRYONIA ALBA ROOT, CALENDULA OFFICINALIS FLOWERING TOP, CAULOPHYLLUM THALICTROIDES ROOT, CAUSTICUM, BLACK COHOSH, GUAIACUM OFFICINALE RESIN, HYPERICUM PERFORATUM, POTASSIUM CARBONATE, LEDUM PALUSTRE TWIG, LITHIUM CARBONATE, FRANGULA CALIFORNICA BARK, RHODODENDRON AUREUM LEAF, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, SALICYLIC ACID, and STELLARIA MEDIA GEL TOPICAL 20131101 UNAPPROVED HOMEOPATHIC Biolyte Laboratories, LLC ACTAEA SPICATA ROOT; ALTHAEA OFFICINALIS ROOT; ARNICA MONTANA; ATROPA BELLADONNA ROOT; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CAULOPHYLLUM THALICTROIDES ROOT; CAUSTICUM; FRANGULA CALIFORNICA BARK; GUAIACUM OFFICINALE RESIN; HORSE CHESTNUT; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; POTASSIUM CARBONATE; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; STELLARIA MEDIA; TOXICODENDRON PUBESCENS LEAF 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 58370-1001_cd5177f9-bbce-46de-a285-72a3a96cb3a4 58370-1001 HUMAN OTC DRUG SOMA Anti-Cancergen ASIAN GINSENG POWDER ORAL 20130306 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd ASIAN GINSENG 5.67 g/100g 58370-1010_c1f7eaa0-af93-4bbc-a39f-63dc5fd9d4ac 58370-1010 HUMAN OTC DRUG SOMA Circum CLOVE PILL ORAL 20130506 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd CLOVE .0275 g/g 58370-1011_e075a7c8-14e3-4265-8e0f-906f1bde2bcd 58370-1011 HUMAN OTC DRUG SOMA Prouri CLOVE PILL ORAL 20130506 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd CLOVE .0275 g/g 58370-1012_c45c6f94-84ad-417d-bb51-810c5e06282e 58370-1012 HUMAN OTC DRUG SOMA Croim CLOVE PILL ORAL 20130506 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd CLOVE .0275 g/g 58370-1013_f2ad0f05-9980-4d3d-8f43-24fd01d69e6d 58370-1013 HUMAN OTC DRUG SOMA Hyulgihwan Gold CLOVE PILL ORAL 20131114 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd ASIAN GINSENG .0567 g/g 58370-2001_0ca43fcf-b0e0-499a-adc2-4ee56c0e80ac 58370-2001 HUMAN OTC DRUG SOMA Hyulgihwan ASIAN GINSENG POWDER ORAL 20130429 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd ASIAN GINSENG 5.67 g/100g 58370-3001_ed857f19-7804-4cd3-9cd1-ce2ad2b70f7f 58370-3001 HUMAN OTC DRUG SOMA Pet-circle ASIAN GINSENG POWDER ORAL 20130429 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd ASIAN GINSENG 5.67 g/100g 58370-4001_12ec6b49-500b-46be-9388-dfd139bda24a 58370-4001 HUMAN OTC DRUG SOMA Disordergen ASIAN GINSENG PILL ORAL 20130502 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd TRAMETES VERSICOLOR FRUITING BODY .05 g/g 58370-5001_7d3c5669-f009-4135-af1e-6e5c90c58230 58370-5001 HUMAN OTC DRUG SOMA Diat TRAMETES VERSICOLOR FRUITING BODY PILL ORAL 20130505 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd TRAMETES VERSICOLOR FRUITING BODY .05 g/g 58370-6001_44e3331e-5454-4c2f-9a04-81a3da3e216f 58370-6001 HUMAN OTC DRUG SOMA Heart-Q TRAMETES VERSICOLOR FRUITING BODY PILL ORAL 20130505 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd TRAMETES VERSICOLOR FRUITING BODY .05 g/g 58370-7001_821ff8bc-fb42-406c-8e92-9b44121b201b 58370-7001 HUMAN OTC DRUG SOMA Atocell TRAMETES VERSICOLOR FRUITING BODY PILL ORAL 20130505 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd TRAMETES VERSICOLOR FRUITING BODY .05 g/g 58370-8001_7adef91f-9fc8-48d8-9fc2-800bc10eacac 58370-8001 HUMAN OTC DRUG SOMA Arthrit TRAMETES VERSICOLOR FRUITING BODY PILL ORAL 20130506 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd TRAMETES VERSICOLOR FRUITING BODY .05 g/g 58370-9001_b8d0edab-8734-40f7-8083-e92e75222b2b 58370-9001 HUMAN OTC DRUG SOMA Hepati TRAMETES VERSICOLOR FRUITING BODY PILL ORAL 20130506 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd TRAMETES VERSICOLOR FRUITING BODY .05 g/g 58381-001_2eb48695-059b-452d-87fc-25e757f4f433 58381-001 HUMAN PRESCRIPTION DRUG Oxygen, Compressed OXYGEN GAS RESPIRATORY (INHALATION) 20130606 UNAPPROVED MEDICAL GAS Pacific BioMedical Supply Inc OXYGEN 1 L/L 58394-001_fd9c4b3e-6ff2-4dfd-ba4b-4344852e654c 58394-001 PLASMA DERIVATIVE BeneFIX coagulation factor ix (recombinant) KIT 19970201 BLA BLA103677 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-002_fd9c4b3e-6ff2-4dfd-ba4b-4344852e654c 58394-002 PLASMA DERIVATIVE BeneFIX coagulation factor ix (recombinant) KIT 19970201 BLA BLA103677 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-003_fd9c4b3e-6ff2-4dfd-ba4b-4344852e654c 58394-003 PLASMA DERIVATIVE BeneFIX coagulation factor ix (recombinant) KIT 19970201 BLA BLA103677 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-004_b01bfce1-a45f-44b5-9672-e4db2287c9df 58394-004 HUMAN PRESCRIPTION DRUG Neumega oprelvekin KIT 19971101 BLA BLA103694 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-008_fd9c4b3e-6ff2-4dfd-ba4b-4344852e654c 58394-008 PLASMA DERIVATIVE BeneFIX coagulation factor ix (recombinant) KIT 19970201 BLA BLA103677 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-012_2e9289a3-fd30-483f-9a7f-be6b29d0fdad 58394-012 PLASMA DERIVATIVE Xyntha Plasma/Albumin-Free antihemophilic factor (Recombinant, Plasma/Albumin-Free) KIT 20080801 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-013_2e9289a3-fd30-483f-9a7f-be6b29d0fdad 58394-013 PLASMA DERIVATIVE Xyntha Plasma/Albumin-Free antihemophilic factor (Recombinant, Plasma/Albumin-Free) KIT 20080801 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-014_2e9289a3-fd30-483f-9a7f-be6b29d0fdad 58394-014 PLASMA DERIVATIVE Xyntha Plasma/Albumin-Free antihemophilic factor (Recombinant, Plasma/Albumin-Free) KIT 20080801 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-015_2e9289a3-fd30-483f-9a7f-be6b29d0fdad 58394-015 PLASMA DERIVATIVE Xyntha Plasma/Albumin-Free antihemophilic factor (Recombinant, Plasma/Albumin-Free) KIT 20080801 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-016_a07937fc-ca09-43e3-8544-92a3ea26effe 58394-016 PLASMA DERIVATIVE Xyntha antihemophilic factor (Recombinant, Plasma/Albumin-Free) KIT 20100813 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-022_a07937fc-ca09-43e3-8544-92a3ea26effe 58394-022 PLASMA DERIVATIVE Xyntha antihemophilic factor (Recombinant, Plasma/Albumin-Free) KIT 20111201 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-023_a07937fc-ca09-43e3-8544-92a3ea26effe 58394-023 PLASMA DERIVATIVE Xyntha antihemophilic factor (Recombinant, Plasma/Albumin-Free) KIT 20111201 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-024_a07937fc-ca09-43e3-8544-92a3ea26effe 58394-024 PLASMA DERIVATIVE Xyntha antihemophilic factor (Recombinant, Plasma/Albumin-Free) KIT 20110801 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-025_a07937fc-ca09-43e3-8544-92a3ea26effe 58394-025 PLASMA DERIVATIVE Xyntha antihemophilic factor (Recombinant, Plasma/Albumin-Free) KIT 20110801 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-633_fd9c4b3e-6ff2-4dfd-ba4b-4344852e654c 58394-633 PLASMA DERIVATIVE BeneFIX coagulation factor ix (recombinant) KIT 19970201 BLA BLA103677 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-634_fd9c4b3e-6ff2-4dfd-ba4b-4344852e654c 58394-634 PLASMA DERIVATIVE BeneFIX coagulation factor ix (recombinant) KIT 19970201 BLA BLA103677 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-635_fd9c4b3e-6ff2-4dfd-ba4b-4344852e654c 58394-635 PLASMA DERIVATIVE BeneFIX coagulation factor ix (recombinant) KIT 19970201 BLA BLA103677 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-636_fd9c4b3e-6ff2-4dfd-ba4b-4344852e654c 58394-636 PLASMA DERIVATIVE BeneFIX coagulation factor ix (recombinant) KIT 19970201 BLA BLA103677 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58394-637_fd9c4b3e-6ff2-4dfd-ba4b-4344852e654c 58394-637 PLASMA DERIVATIVE BeneFIX coagulation factor ix (recombinant) KIT 20120201 BLA BLA103677 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 58399-1001_2fd4e561-efc9-4704-81a6-3f98069e7f45 58399-1001 HUMAN OTC DRUG Aquapick Whitening Bubblepick SODIUM FLUORIDE LIQUID DENTAL 20130502 OTC MONOGRAPH FINAL part355 Aquapick Co., Ltd SODIUM FLUORIDE .001 mg/mL 58401-102_cb79d48a-3742-463d-b9ba-a35224f5d72e 58401-102 HUMAN OTC DRUG PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY RECTAL 20140903 OTC MONOGRAPH FINAL part346 Aditya Labs Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 85.5; .25 g/100g; g/100g 58404-001_65a2e84a-bb57-418f-8b84-c8e74ad18bc0 58404-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130501 UNAPPROVED MEDICAL GAS Industrial Welding & Tool Supply, Ltd. OXYGEN 995 mL/L 58404-002_21918521-1211-43ef-9009-7f9d9fc4eb13 58404-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20130501 UNAPPROVED MEDICAL GAS Industrial Welding & Tool Supply, Ltd. NITROGEN 995 mL/L 58406-425_491e2358-832f-46a6-aae4-0bc35490ff48 58406-425 HUMAN PRESCRIPTION DRUG ENBREL etanercept KIT 20030102 BLA BLA103795 Immunex Corporation 58406-435_491e2358-832f-46a6-aae4-0bc35490ff48 58406-435 HUMAN PRESCRIPTION DRUG ENBREL etanercept SOLUTION SUBCUTANEOUS 20051006 BLA BLA103795 Immunex Corporation ETANERCEPT 50 mg/mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] 58406-445_491e2358-832f-46a6-aae4-0bc35490ff48 58406-445 HUMAN PRESCRIPTION DRUG ENBREL etanercept SOLUTION SUBCUTANEOUS 20051110 BLA BLA103795 Immunex Corporation ETANERCEPT 50 mg/mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] 58406-455_491e2358-832f-46a6-aae4-0bc35490ff48 58406-455 HUMAN PRESCRIPTION DRUG ENBREL etanercept SOLUTION SUBCUTANEOUS 20051110 BLA BLA103795 Immunex Corporation ETANERCEPT 25 mg/.5mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] 58407-025_6eb82a3c-0754-4e85-ac57-9e0064dfd5d4 58407-025 HUMAN OTC DRUG AHIST CHLORCYCLIZINE HYDROCHLORIDE TABLET ORAL 20130115 OTC MONOGRAPH NOT FINAL part341 Magna Pharmaceutcals, Inc. CHLORCYCLIZINE HYDROCHLORIDE 25 mg/1 58407-091_1fa764ce-8465-4d42-a2b6-0ebafebf79d2 58407-091 HUMAN PRESCRIPTION DRUG Stagesic hydrocodone bitartrate and acetaminophen CAPSULE ORAL 19990607 ANDA ANDA089008 Magna Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 58407-125_7b40823d-e425-4dd5-8000-9d4bfc9cf8fd 58407-125 HUMAN OTC DRUG STATUSS GREEN CHLORCYCLIZINE HYDROCHLORIDE, CODEINE PHOSPHATE, and PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20111220 OTC MONOGRAPH FINAL part341 Magna Pharmaceuticals, Inc. CHLORCYCLIZINE HYDROCHLORIDE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 12.5; 9; 30 mg/5mL; mg/5mL; mg/5mL CV 58407-225_4333db63-7fbc-452f-9134-75af11390cf9 58407-225 HUMAN OTC DRUG STAFLEX ACETAMINOPHEN and BROMPHENIRAMINE MALEATE TABLET ORAL 20141124 OTC MONOGRAPH FINAL part341 Magna Pharmaceuticals, Inc. ACETAMINOPHEN; BROMPHENIRAMINE MALEATE 250; 2 mg/1; mg/1 58407-239_309146ae-34be-4dac-945f-7ba8f8732513 58407-239 HUMAN OTC DRUG Z-TUSS E Codeine Phosphate/Guaifenesin/Pseudoephedrine Hydrochloride LIQUID ORAL 20111012 OTC MONOGRAPH FINAL part341 Magna Pharmaceuticals, Inc. CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 9; 200; 30 mg/5mL; mg/5mL; mg/5mL CV 58407-534_dbc16215-67e8-498d-99c6-340c70aafb69 58407-534 HUMAN PRESCRIPTION DRUG Capacet butalbital, acetaminophen and caffeine CAPSULE ORAL 20110502 ANDA ANDA089007 Magna Pharmaceuticals ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 58407-624_eb16e7b6-485d-47d1-ab04-90b65677fa48 58407-624 HUMAN OTC DRUG Stahist AD Chlorcyclizine Hydrochloride and Pseudoephedrine Hydrochloride LIQUID ORAL 20120401 OTC MONOGRAPH FINAL part341 MAGNA Pharmaceuticals, Inc. CHLORCYCLIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 25; 60 mg/5mL; mg/5mL 58407-625_88837b25-44c9-47ec-9e8b-a26ee3cb2419 58407-625 HUMAN OTC DRUG STAHIST AD CHLORCYCLIZINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE TABLET ORAL 20111220 OTC MONOGRAPH FINAL part341 Magna Pharmaceuticals, Inc. CHLORCYCLIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 25; 60 mg/1; mg/1 58407-920_3bd79511-0084-4b97-ac88-b0bf07462692 58407-920 HUMAN OTC DRUG Z-TUSS AC Chlorpheniramine Maleate, Codeine Phosphate LIQUID ORAL 20110111 OTC MONOGRAPH FINAL part341 Magna Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 2; 9 mg/5mL; mg/5mL CV 58411-101_538734fc-a5ff-49dc-a2c6-923bdb1a00a7 58411-101 HUMAN OTC DRUG SHISEIDO IBUKI PROTECTIVE MOISTURIZER AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 1903; 5633; 1522; 761 mg/76.12g; mg/76.12g; mg/76.12g; mg/76.12g 58411-102_f92d4ece-9030-45da-aa54-97557cac8bd1 58411-102 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL PROTECTIVE AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1255; 3715; 1004 mg/50.2g; mg/50.2g; mg/50.2g 58411-103_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-103 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION I00 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-104_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-104 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION I20 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-105_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-105 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION I40 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-106_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-106 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION I60 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-107_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-107 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION I100 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-108_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-108 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION B00 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-109_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-109 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION B20 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-110_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-110 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION B40 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-111_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-111 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION B60 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-112_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-112 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION B100 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-113_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-113 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION O00 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-114_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-114 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION O20 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-115_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-115 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION O40 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-116_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-116 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION O60 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-117_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-117 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION O80 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-118_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-118 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION D10 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-119_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-119 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION D20 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-120_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-120 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION D30 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g 58411-121_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-121 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORY OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g 58411-122_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-122 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT BEIGE OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g 58411-123_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-123 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT IVORY OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g 58411-124_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-124 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT OCHRE OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g 58411-125_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-125 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM BEIGE OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g 58411-126_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-126 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM IVORY OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g 58411-127_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-127 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM OCHRE OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g 58411-128_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-128 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) DARK BEIGE OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g 58411-129_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-129 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) DARK IVORY OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g 58411-130_d70c8374-1f1e-4e3d-8709-4b36462dc33c 58411-130 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION LIGHT BEIGE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 644; 2814 mg/33.9g; mg/33.9g 58411-131_d70c8374-1f1e-4e3d-8709-4b36462dc33c 58411-131 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION LIGHT IVORY OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 644; 2814 mg/33.9g; mg/33.9g 58411-132_d70c8374-1f1e-4e3d-8709-4b36462dc33c 58411-132 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION LIGHT OCHRE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 644; 2814 mg/33.9g; mg/33.9g 58411-133_d70c8374-1f1e-4e3d-8709-4b36462dc33c 58411-133 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION MEDIUM BEIGE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 644; 2814 mg/33.9g; mg/33.9g 58411-134_d70c8374-1f1e-4e3d-8709-4b36462dc33c 58411-134 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION MEDIUM IVORY OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 644; 2814 mg/33.9g; mg/33.9g 58411-135_d70c8374-1f1e-4e3d-8709-4b36462dc33c 58411-135 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION DARK BEIGE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 644; 2814 mg/33.9g; mg/33.9g 58411-136_d70c8374-1f1e-4e3d-8709-4b36462dc33c 58411-136 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION DARK IVORY OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 644; 2814 mg/33.9g; mg/33.9g 58411-137_631e4cce-435e-4916-82c8-eb44d919e165 58411-137 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORY OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 261; 648 mg/9g; mg/9g 58411-138_631e4cce-435e-4916-82c8-eb44d919e165 58411-138 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION FAIR OCHRE OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 261; 648 mg/9g; mg/9g 58411-139_631e4cce-435e-4916-82c8-eb44d919e165 58411-139 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION BEIGE OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 261; 648 mg/9g; mg/9g 58411-140_631e4cce-435e-4916-82c8-eb44d919e165 58411-140 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION OCHRE OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 261; 648 mg/9g; mg/9g 58411-141_eb7b9e3d-9e11-4aae-bb1a-126eb197c71c 58411-141 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL PROTECTIVE AVOBENZONE, OCTINOXATE, and OCTOCRYLENE EMULSION TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1896; 5611; 1517 mg/75.83g; mg/75.83g; mg/75.83g 58411-142_9a3ba2c0-0122-4a43-bfce-4ec530a2fee4 58411-142 HUMAN OTC DRUG SHISEIDO ULTIMATE SUN PROTECTION AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE SPRAY TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.98; 19.89; 6.63; 3.32; 6.63 mg/132.6g; mg/132.6g; mg/132.6g; mg/132.6g; mg/132.6g 58411-143_bf72a6f6-ead7-404c-8f8e-130cbac8c7d6 58411-143 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFRESHING PROTECTIVE I AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE EMULSION TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3163; 9361; 2530; 1265 mg/126.5g; mg/126.5g; mg/126.5g; mg/126.5g 58411-144_ed796daa-6bc5-4691-a17b-8a7bf67d9829 58411-144 HUMAN OTC DRUG CLE DE PEAU BEAUTE GENTLE PROTECTIVE I AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE EMULSION TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3163; 9361; 2530; 1265 mg/126.5g; mg/126.5g; mg/126.5g; mg/126.5g 58411-145_ebadc1fb-8c38-4ac6-b082-f09803fa43c7 58411-145 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION L BF20 Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 656 mg/31.25g 58411-146_ebadc1fb-8c38-4ac6-b082-f09803fa43c7 58411-146 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION L I10 Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 656 mg/31.25g 58411-147_ebadc1fb-8c38-4ac6-b082-f09803fa43c7 58411-147 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION L O10 Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 656 mg/31.25g 58411-148_ebadc1fb-8c38-4ac6-b082-f09803fa43c7 58411-148 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION L O20 Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 656 mg/31.25g 58411-149_ebadc1fb-8c38-4ac6-b082-f09803fa43c7 58411-149 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION L O30 Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 656 mg/31.25g 58411-150_ebadc1fb-8c38-4ac6-b082-f09803fa43c7 58411-150 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION L B10 Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 656 mg/31.25g 58411-151_ebadc1fb-8c38-4ac6-b082-f09803fa43c7 58411-151 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION L B20 Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 656 mg/31.25g 58411-152_ebadc1fb-8c38-4ac6-b082-f09803fa43c7 58411-152 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION L B30 Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 656 mg/31.25g 58411-153_d3f4b615-9ab7-42b9-b768-ef332057b0a6 58411-153 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I BF20 Octinoxate and Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 539; 1.16 mg/28.35g; g/28.35g 58411-154_d3f4b615-9ab7-42b9-b768-ef332057b0a6 58411-154 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I I10 Octinoxate and Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 539; 1.16 mg/28.35g; g/28.35g 58411-155_d3f4b615-9ab7-42b9-b768-ef332057b0a6 58411-155 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I O10 Octinoxate and Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 539; 1.16 mg/28.35g; g/28.35g 58411-156_d3f4b615-9ab7-42b9-b768-ef332057b0a6 58411-156 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I O20 Octinoxate and Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 539; 1.16 mg/28.35g; g/28.35g 58411-157_d3f4b615-9ab7-42b9-b768-ef332057b0a6 58411-157 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I O30 Octinoxate and Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 539; 1.16 mg/28.35g; g/28.35g 58411-158_d3f4b615-9ab7-42b9-b768-ef332057b0a6 58411-158 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I B10 Octinoxate and Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 539; 1.16 mg/28.35g; g/28.35g 58411-159_d3f4b615-9ab7-42b9-b768-ef332057b0a6 58411-159 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I B20 Octinoxate and Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 539; 1.16 mg/28.35g; g/28.35g 58411-160_d3f4b615-9ab7-42b9-b768-ef332057b0a6 58411-160 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I B30 Octinoxate and Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 539; 1.16 mg/28.35g; g/28.35g 58411-161_d78a1818-e592-454c-9cc0-f8d3c4d0314c 58411-161 HUMAN OTC DRUG SHISEIDO SUN PROTECTION OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 441; 828 mg/9g; mg/9g 58411-162_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-162 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I00 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-163_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-163 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I20 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-164_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-164 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I40 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-165_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-165 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I60 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-166_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-166 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B20 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-167_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-167 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B40 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-168_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-168 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B60 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-169_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-169 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O20 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-170_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-170 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O40 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-171_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-171 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O60 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-172_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-172 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O80 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-173_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-173 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O00 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-174_deb54724-c0bb-4d9c-9d39-d3daf1aa4df4 58411-174 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B00 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-175_deb54724-c0bb-4d9c-9d39-d3daf1aa4df4 58411-175 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B100 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-176_deb54724-c0bb-4d9c-9d39-d3daf1aa4df4 58411-176 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I100 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-177_deb54724-c0bb-4d9c-9d39-d3daf1aa4df4 58411-177 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) WB40 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-178_deb54724-c0bb-4d9c-9d39-d3daf1aa4df4 58411-178 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) WB60 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g 58411-179_5cb5d807-a8ef-4e40-9013-26f8b2dea937 58411-179 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) D10 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 864 mg/12g 58411-180_5cb5d807-a8ef-4e40-9013-26f8b2dea937 58411-180 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) D20 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 864 mg/12g 58411-181_5cb5d807-a8ef-4e40-9013-26f8b2dea937 58411-181 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) D30 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 864 mg/12g 58411-182_c987ab6d-007b-48f1-a590-fae85b97c372 58411-182 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION I00 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g 58411-183_c987ab6d-007b-48f1-a590-fae85b97c372 58411-183 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION I20 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g 58411-184_c987ab6d-007b-48f1-a590-fae85b97c372 58411-184 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION I40 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g 58411-185_c987ab6d-007b-48f1-a590-fae85b97c372 58411-185 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION I60 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g 58411-186_c987ab6d-007b-48f1-a590-fae85b97c372 58411-186 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION B20 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g 58411-187_c987ab6d-007b-48f1-a590-fae85b97c372 58411-187 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION B40 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g 58411-188_c987ab6d-007b-48f1-a590-fae85b97c372 58411-188 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION B60 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g 58411-189_c987ab6d-007b-48f1-a590-fae85b97c372 58411-189 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION O20 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g 58411-190_c987ab6d-007b-48f1-a590-fae85b97c372 58411-190 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION O40 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g 58411-191_c987ab6d-007b-48f1-a590-fae85b97c372 58411-191 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION O60 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g 58411-192_443524d5-652f-454d-8a7c-57ff1aec892d 58411-192 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION Control Color Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 250 mg/10g 58411-193_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-193 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION I10 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL 58411-194_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-194 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O10 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL 58411-195_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-195 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL 58411-196_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-196 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O30 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL 58411-197_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-197 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL 58411-198_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-198 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O50 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL 58411-199_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-199 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL 58411-200_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-200 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B10 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL 58411-201_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-201 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL 58411-202_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-202 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B30 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL 58411-203_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-203 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL 58411-204_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-204 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION WB20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL 58411-205_86a26d44-1211-48ea-9e37-f85a1180db1d 58411-205 HUMAN OTC DRUG CLE DE PEAU BEAUTE CORRECTING VEIL ENSULIZOLE, OCTINOXATE, and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 397; 1153; 954 mg/36mL; mg/36mL; mg/36mL 58411-206_d44e2791-ad0e-43ca-b013-3f9ab0132fea 58411-206 HUMAN OTC DRUG CLE DE PEAU BEAUTE SHEER FLUID VEIL AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE 771; 2282; 617 mg/30mL; mg/30mL; mg/30mL 58411-207_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-207 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) I00 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-208_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-208 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) I20 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-209_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-209 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) I40 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-210_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-210 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) I60 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-211_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-211 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) I100 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-212_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-212 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) B00 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-213_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-213 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) B20 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-214_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-214 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) B40 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-215_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-215 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) B60 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-216_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-216 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) B100 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-217_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-217 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) O00 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-218_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-218 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) O20 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-219_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-219 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) O40 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-220_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-220 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) O60 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-221_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-221 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) O80 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-222_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-222 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) D10 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-223_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-223 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) D20 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-224_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-224 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) D30 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g 58411-225_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-225 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION I00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL 58411-226_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-226 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION I20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL 58411-227_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-227 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION I40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL 58411-228_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-228 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION I60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL 58411-229_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-229 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION B20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL 58411-230_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-230 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION B40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL 58411-231_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-231 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION B60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL 58411-232_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-232 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION O00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL 58411-233_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-233 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION O20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL 58411-234_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-234 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION O40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL 58411-235_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-235 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION O60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL 58411-236_7fa8e782-cd79-4c07-b179-4eb3a28fab31 58411-236 HUMAN OTC DRUG CLE DE PEAU BEAUTE HAND AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1191; 5656; 1529 mg/75mL; mg/75mL; mg/75mL 58411-237_175aab9c-07ac-45a4-8371-0f1c53da6f6e 58411-237 HUMAN OTC DRUG CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER n AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE 518; 1532; 414 mg/20mL; mg/20mL; mg/20mL 58414-2020_a1b984bc-50cd-4cad-b3bc-dca95b764546 58414-2020 HUMAN OTC DRUG Exuviance Clear and Smooth Daily Exfoliating Anti- Blemish Pads SALICYLIC ACID LIQUID TOPICAL 20130715 20150228 OTC MONOGRAPH FINAL part333D NeoStrata Company Inc. SALICYLIC ACID 20 mg/mL 58414-2040_67969e64-5ce5-4cc7-aed4-21ddb3cc127f 58414-2040 HUMAN OTC DRUG Exuviance Age Reverse Day Repair SPF 30 AVOBENZONE, OCTINOXATE, and OCTISALATE CREAM TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/g; mg/g; mg/g 58414-2046_41083c54-b919-4cf9-9068-618644646e40 58414-2046 HUMAN OTC DRUG Exuviance Essential Daily Defense SPF 30 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 40 mg/g; mg/g 58414-2047_9bec5055-0984-4fab-b4f4-128f8e03ba97 58414-2047 HUMAN OTC DRUG Exuviance Sheer Refining Fluid SPF 35 OCTINOXATE, OCTISALATE, and AVOBENZONE LOTION TOPICAL 20130702 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL 58414-2048_4f3c4518-7bac-4fbc-a856-4daa767b4b61 58414-2048 HUMAN OTC DRUG Exuviance Multi Protective Day SPF 20 Octinoxate and Titanium Dioxide CREAM TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 40 mg/g; mg/g 58414-3042_8b17e3fa-e4f6-4329-93cf-dbe9f2e748c5 58414-3042 HUMAN OTC DRUG NeoStrata Skin Active Matrix Support SPF 30 AVOBENZONE, OCTINOXATE, and OCTISALATE CREAM TOPICAL 20130718 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/g; mg/g; mg/g 58414-3046_5afbdaad-39a8-47dd-9cd1-ec7953e5e891 58414-3046 HUMAN OTC DRUG NeoStrata Ultra Daytime Smoothing SPF 20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20130718 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 40 mg/g; mg/g 58414-3047_7a221941-74b8-4946-a1e6-c75aadf7c301 58414-3047 HUMAN OTC DRUG NeoStrata Sheer Hydration SPF 35 OCTINOXATE, OCTISALATE, and AVOBENZONE LOTION TOPICAL 20130730 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 ug/mL; mg/mL; mg/mL 58414-3048_8cca94a8-ec74-4d7a-9106-ae3b77c89341 58414-3048 HUMAN OTC DRUG NeoStrata Daytime Protection SPF 23 Octinoxate and Titanium Dioxide CREAM TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 40 mg/g; mg/g 58414-3501_bd1a817b-1eb7-4d2e-b7d9-f374cf85e387 58414-3501 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Bisque TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 159.7; 20.9 mg/g; mg/g 58414-3502_e44a5e2f-b3fe-46f0-8314-60cf6dc17a29 58414-3502 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Classic Beige TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 152.9; 20.9 mg/g; mg/g 58414-3503_7b9626ca-c8dc-43d0-bea3-f0be85ff1bf0 58414-3503 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Warm Beige TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 153.4; 20.9 mg/g; mg/g 58414-3504_d1119860-0f25-45d2-84e7-5802098bbb22 58414-3504 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Neutral Sand TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 152.9; 20.9 mg/g; mg/g 58414-3505_fc59dc5a-3bd5-441a-8e08-c5eedd85e374 58414-3505 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 True Beige TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 148; 20.9 mg/g; mg/g 58414-3506_ba4bffed-a5bc-4066-ad28-f3c15b744ff5 58414-3506 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Golden Beige TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 143; 20.9 mg/g; mg/g 58414-3507_818d717d-8453-4cc2-963a-9cc8d2a7bdb8 58414-3507 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Toasted Almond TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 137.1; 20.9 mg/g; mg/g 58414-3508_850113ac-7587-480b-9f6f-d443ca4180af 58414-3508 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Honey Sand TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 143.6; 20.9 mg/g; mg/g 58414-3509_50caa416-6462-4a05-93fe-33429741a203 58414-3509 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Desert Sand TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 131.1; 20.9 mg/g; mg/g 58414-3510_116468ef-9aa3-4ecc-bf74-614f09e9a323 58414-3510 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Terracotta Sand TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 120.9; 20.9 mg/g; mg/g 58414-3511_ccf1efaa-2254-496b-90ce-fc0c7e678f95 58414-3511 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Caramel TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 103; 20.9 mg/g; mg/g 58414-3512_e04ebaac-9378-404e-8594-fbdabbb547a0 58414-3512 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Mocha TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 85.8; 20.9 mg/g; mg/g 58414-8321_fde8c45a-5e67-4a8f-8f79-da5311355db3 58414-8321 HUMAN OTC DRUG NeoStrata Antibacterial Facial Cleanser TRICLOSAN LIQUID TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part333E NeoStrata Company Inc TRICLOSAN 3 mg/mL 58414-8712_aeb13914-ca1d-4c5e-b322-4e6d3e2b03cf 58414-8712 HUMAN OTC DRUG Blemish Treatment Salicylic Acid GEL TOPICAL 20101030 OTC MONOGRAPH FINAL part333D NeoStrata Company Inc SALICYLIC ACID .02 g/g 58414-8723_8d74cfff-7c90-49c2-85d9-4a802492b8a5 58414-8723 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 15 Ivory TITANIUM DIOXIDE LIQUID TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE 97 mg/mL 58414-8724_8d74cfff-7c90-49c2-85d9-4a802492b8a5 58414-8724 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 15 Bisque TITANIUM DIOXIDE LIQUID TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE 97 mg/mL 58414-8725_8d74cfff-7c90-49c2-85d9-4a802492b8a5 58414-8725 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 15 Blush Beige TITANIUM DIOXIDE LIQUID TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE 97 mg/mL 58414-8726_8d74cfff-7c90-49c2-85d9-4a802492b8a5 58414-8726 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 15 True Beige TITANIUM DIOXIDE LIQUID TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE 97 mg/mL 58414-8727_8d74cfff-7c90-49c2-85d9-4a802492b8a5 58414-8727 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 15 Neutral Beige TITANIUM DIOXIDE LIQUID TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE 97 mg/mL 58414-8728_8d74cfff-7c90-49c2-85d9-4a802492b8a5 58414-8728 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 15 Warm Beige TITANIUM DIOXIDE LIQUID TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE 97 mg/mL 58414-8729_8d74cfff-7c90-49c2-85d9-4a802492b8a5 58414-8729 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 15 Honey Sand TITANIUM DIOXIDE LIQUID TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE 97 mg/mL 58414-8730_876b9e84-059d-4d60-8eed-652faf902973 58414-8730 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 15 Neutral Sand TITANIUM DIOXIDE LIQUID TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE 83 mg/mL 58414-8731_876b9e84-059d-4d60-8eed-652faf902973 58414-8731 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 15 Desert Sand TITANIUM DIOXIDE LIQUID TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE 83 mg/mL 58414-8732_876b9e84-059d-4d60-8eed-652faf902973 58414-8732 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 15 Terracotta Sand TITANIUM DIOXIDE LIQUID TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE 83 mg/mL 58414-8735_3cc9a913-1c38-4eb8-9b44-7929e0be134c 58414-8735 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 15 True Mahogany TITANIUM DIOXIDE LIQUID TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE 84 mg/mL 58414-8748_4b9698f8-79bc-43fc-85a0-b32f0db4b2dc 58414-8748 HUMAN OTC DRUG Exuviance Moisturizing Antibacterial Facial Cleanser TRICLOSAN LIQUID TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part333E NeoStrata Company Inc TRICLOSAN 3 mg/mL 58414-8750_f80f9727-4e3c-45ca-97e7-4ea22ca60efc 58414-8750 HUMAN OTC DRUG Exuviance Intense Lightening Complex HYDROQUINONE GEL TOPICAL 20110222 OTC MONOGRAPH NOT FINAL part358A NeoStrata Company Inc HYDROQUINONE .02 g/g 58414-8808_2d19bb72-550d-429e-821f-10ebaa3ba506 58414-8808 HUMAN OTC DRUG NeoStrata HQ Skin Lightening HYDROQUINONE GEL TOPICAL 20110222 OTC MONOGRAPH NOT FINAL part358A NeoStrata Company Inc HYDROQUINONE .02 g/g 58414-8960_e5c287f6-4944-4d21-b572-8349c367040e 58414-8960 HUMAN OTC DRUG Psorent COAL TAR SOLUTION TOPICAL 20130717 OTC MONOGRAPH FINAL part358H NeoStrata Company Inc. COAL TAR 23 mg/mL 58416-001_5a36a041-c43f-439e-8581-e3afe90aff4c 58416-001 HUMAN OTC DRUG Nelly de Vuyst SPF 30 Broad Spectrum Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20141023 OTC MONOGRAPH NOT FINAL part352 Derme.ca AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; .1; 50; 20; 25 mg/g; g/g; mg/g; mg/g; mg/g 58420-001_6d5083ee-2a43-4388-afb0-ae7bc37ef146 58420-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19750101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc OXYGEN 992 mL/L 58420-002_5d1f77ff-b355-4463-9f8b-a75bdb6b4d93 58420-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19750101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc NITROGEN 992 mL/L 58420-003_275e87da-a1ba-4e2f-8dd7-0cf598db21ee 58420-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc NITROUS OXIDE 992 mL/L 58420-004_17eaf086-da43-45a9-96f7-4963599d8041 58420-004 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc HELIUM 992 mL/L 58420-005_eb13cea1-3db6-4606-80ee-bbbea7f570dd 58420-005 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19580101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc AIR 1000 mL/L 58420-006_831a4542-6a79-419b-b286-2d8362e52d46 58420-006 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc CARBON DIOXIDE 992 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 58420-007_3d051449-4685-42c2-b8d1-fa928c82d55c 58420-007 HUMAN PRESCRIPTION DRUG Helium Oxygen Mixture Helium Oxygen Mixture GAS RESPIRATORY (INHALATION) 19980101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc HELIUM; OXYGEN 800; 200 mL/L; mL/L 58420-009_6ebe9ecb-fa0c-44ef-847d-11365dc23c26 58420-009 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mixture Carbon Dioxide Oxygen Mixture GAS RESPIRATORY (INHALATION) 19980101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc CARBON DIOXIDE; OXYGEN 300; 700 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 58443-0015_a75d6a30-96e6-4c95-8440-4136733bccc0 58443-0015 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 8 Avobenzone, Octocrylene, and Oxybenzone LOTION TOPICAL 20120420 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 10; 27.5; 10 mg/mL; mg/mL; mg/mL 58443-0016_c76f75fa-464b-4c95-a507-16fe3ef41f84 58443-0016 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120420 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.9; 49.9; 27.5; 4.9 mg/mL; mg/mL; mg/mL; mg/mL 58443-0017_00c73d53-cc3a-41a2-9359-fea160d61fc0 58443-0017 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120619 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 75.1; 50.1; 27.5; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58443-0018_f3860591-f938-4068-831d-5d8511bddf60 58443-0018 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120619 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 75.1; 50.1; 27.5; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58443-0019_4eaa73c1-bb87-48c5-9a30-c6bf61099549 58443-0019 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120619 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 75.1; 50.1; 27.5; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58443-0020_0047124a-c2f2-402a-9cd6-885d8033fd66 58443-0020 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120321 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.7; 102.3; 51.2; 28.1; 40.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58443-0021_276758c8-c469-441e-90d4-7ed37a5e0232 58443-0021 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 4 Avobenzone, Octocrylene, and Oxybenzone OIL TOPICAL 20121113 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 4.46; 8.92; 4.46 mg/mL; mg/mL; mg/mL 58443-0022_4fe46cdf-e909-4331-9516-b926d5d8d3d1 58443-0022 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 4 Avobenzone, Octocrylene, and Oxybenzone LOTION TOPICAL 20120409 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 4.9; 9.8; 4.9 mg/mL; mg/mL; mg/mL 58443-0023_cf49327e-c9e9-49ff-ab6f-4850442c96b6 58443-0023 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 8 Avobenzone, Octocrylene, and Oxybenzone LOTION TOPICAL 20120416 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 9.7; 26.8; 9.7 mg/mL; mg/mL; mg/mL 58443-0024_c47045b1-330f-4919-b700-5fdc776ec754 58443-0024 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20111213 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.7; 49.4; 27.1; 4.9 mg/mL; mg/mL; mg/mL; mg/mL 58443-0025_5d7d39df-f05e-4b3e-8e16-0b4b12c72d5c 58443-0025 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20111229 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.6; 73.4; 48.9; 26.9; 19.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58443-0026_ebdacfd1-cb2e-4be1-bfbb-e9a478aebeaf 58443-0026 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 8 Avobenzone, Octocrylene, and Oxybenzone LOTION TOPICAL 20120702 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 9.5; 26.2; 9.5 mg/mL; mg/mL; mg/mL 58443-0027_f80ec605-7ff0-4137-8b78-8bab19ddbe8f 58443-0027 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120328 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.7; 49; 26.9; 4.9 mg/mL; mg/mL; mg/mL; mg/mL 58443-0028_08b0ea7b-778a-4ab4-93ba-3bee9b5a200d 58443-0028 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120326 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.5; 73.1; 48.8; 26.8; 19.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58443-0029_a3846dc3-e122-4768-90a6-a7ddd4f82449 58443-0029 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 8 Avobenzone, Octocrylene, and Oxybenzone LOTION TOPICAL 20131118 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 4.9; 19.4; 14.6 mg/mL; mg/mL; mg/mL 58443-0030_ebbc35c6-19a3-48ba-9048-847c88814f98 58443-0030 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20131025 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 19.5; 48.7; 26.8 mg/mL; mg/mL; mg/mL 58443-0031_6b801bd1-c0c5-4ebb-bc93-59ace5990de2 58443-0031 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130729 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.8; 74; 49.4; 27.1; 19.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58443-0032_84234bb2-781f-41cf-a5c6-a3c9cb652b17 58443-0032 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 45 Avobenzone,Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20130125 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 28.9; 144.3; 48.1; 26.5 mg/mL; mg/mL; mg/mL; mg/mL 58443-0033_258384b5-d3da-4f2e-a551-ed5a14ca0817 58443-0033 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 45 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130204 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.6; 102; 51; 28.1; 20.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58443-0034_fe70a6a5-3401-42f7-aff3-2b9bc1a02a8c 58443-0034 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 4 Avobenzone, Octocrylene, and Oxybenzone LOTION TOPICAL 20131019 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 9.8; 8.3; 4.9 mg/mL; mg/mL; mg/mL 58443-0035_d328b72b-e3d4-408c-bdd9-f40fedd6289c 58443-0035 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 8 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131014 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 9.9; 29.7; 8.4; 9.9 mg/mL; mg/mL; mg/mL; mg/mL 58443-0037_a3710a41-b2d4-4aa7-ba45-efa292b06a88 58443-0037 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131015 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.7; 49.3; 18.2; 4.9 mg/mL; mg/mL; mg/mL; mg/mL 58443-0040_278de50d-919e-4663-98e9-4d05b29701a1 58443-0040 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131215 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.5; 76.1; 50.8; 27.5; 20.3 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58443-0042_22b0c855-d213-46a8-8b7a-1c051b47d4df 58443-0042 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131215 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.5; 76.1; 50.8; 27.5; 20.3 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58448-001_6478fa96-04cf-441a-b8a0-5fdf058b5620 58448-001 HUMAN OTC DRUG Turf Screen Crew Broad Spectrum Sunscreen AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20130503 OTC MONOGRAPH NOT FINAL part352 Turf Max, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 100; 75; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58463-002_57ea4662-47c1-4225-9dcc-545e4882664b 58463-002 HUMAN PRESCRIPTION DRUG MOXATAG amoxicillin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140728 NDA NDA050813 Pragma Pharmaceuticals, LLC AMOXICILLIN 775 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 58466-013_973252f0-e9cc-4256-abb2-50b70b35dd9e 58466-013 HUMAN OTC DRUG nanocare Dimethicone LOTION TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part332 Dermazone Solutions, Inc. DIMETHICONE 10 mg/mL 58466-016_7cbbf0c6-3339-4d2e-9111-02104a7f1ead 58466-016 HUMAN OTC DRUG Celazome Fade Shades Lightening Cream w/ Glycolic Acid Hydroquinone LOTION TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part358A Dermazone Solutions, LLC HYDROQUINONE 2 g/14.25g 58466-023_f40e76f0-bb3e-41ad-9587-b8afe6f2ac8f 58466-023 HUMAN OTC DRUG Celazome Botanical Mositurizer with SPF 15 Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20040101 OTC MONOGRAPH FINAL part352 Dermazone Solutions, LLC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 3; 5 g/59mL; g/59mL; g/59mL 58466-024_0f895e98-07ff-42c9-9e2a-17f6e328dae5 58466-024 HUMAN OTC DRUG nanocare Dimethicone CREAM TOPICAL 20121015 OTC MONOGRAPH NOT FINAL part332 Deramzone Solutions, Inc. DIMETHICONE 10 mg/mL 58466-027_17a39a1a-4877-47ca-a2a1-1dbe91abbdd3 58466-027 HUMAN OTC DRUG Celazome O-Plex Control Salicylic Acid LOTION TOPICAL 20040101 OTC MONOGRAPH FINAL part358 Dermazone Solutions, LLC SALICYLIC ACID .5 g/59g 58466-033_4d7b98e6-4b6a-461b-8735-7d889c233685 58466-033 HUMAN OTC DRUG nanocare Moisturizing Sunscreen SPF 50 Benzophenone, Avobenzone, Octisalate, Homosalate, and Octocrylene LOTION TOPICAL 20121015 OTC MONOGRAPH FINAL part352 Deramzone Solutions, Inc. AVOBENZONE; BENZOPHENONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 60; 100; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58466-101_2eedb48d-5d59-4090-b86c-d274b74ede07 58466-101 HUMAN OTC DRUG Celazome Moisturizing Sunscreen with SPF 30 Oxybenzone, Octinoxate, Octisalate, and Homosalate LOTION TOPICAL 20040101 OTC MONOGRAPH FINAL part352 Dermazone Solutions, LLC HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 5.9; 8.9; 5.9; 8.9 g/118mL; g/118mL; g/118mL; g/118mL 58466-104_902c1ff7-8a54-429a-8039-4302601e682e 58466-104 HUMAN OTC DRUG Celazome Mositurizing Sunscreen with SPF 29 Oxybenzone, Octinoxate, Octisalate, Homosalate, and Avobenzone LOTION TOPICAL 20040101 OTC MONOGRAPH FINAL part352 Dermazone Solutions, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.4; 5.9; 8.9; 5.9; 5.9 g/118mL; g/118mL; g/118mL; g/118mL; g/118mL 58468-0020_c4f2b7c1-79ca-446c-8a20-fa002334f1c3 58468-0020 HUMAN PRESCRIPTION DRUG Renagel Renagel TABLET ORAL 20080606 NDA NDA021179 Genzyme Corporation SEVELAMER HYDROCHLORIDE 400 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 58468-0021_c4f2b7c1-79ca-446c-8a20-fa002334f1c3 58468-0021 HUMAN PRESCRIPTION DRUG Renagel Renagel TABLET ORAL 20080606 NDA NDA021179 Genzyme Corporation SEVELAMER HYDROCHLORIDE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 58468-0030_b9da8016-40ba-4e81-85c8-911862339cee 58468-0030 HUMAN PRESCRIPTION DRUG Thyrogen THYROTROPIN ALFA INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 19981130 NDA NDA020898 Genzyme Corporation THYROTROPIN ALFA .9 mg/mL Thyroid Stimulating Hormone [EPC],Thyrotropin [Chemical/Ingredient] 58468-0040_1062d32d-80a0-43eb-b5fa-78c3ea27504e 58468-0040 HUMAN PRESCRIPTION DRUG Fabrazyme AGALSIDASE BETA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081217 BLA BLA103979 Genzyme Corporation AGALSIDASE BETA 5 mg/mL alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC] 58468-0041_1062d32d-80a0-43eb-b5fa-78c3ea27504e 58468-0041 HUMAN PRESCRIPTION DRUG Fabrazyme AGALSIDASE BETA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081217 BLA BLA103979 Genzyme Corporation AGALSIDASE BETA 5 mg/mL alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC] 58468-0070_df4c73fa-a96d-478e-8b2d-d63bbba6eb25 58468-0070 HUMAN PRESCRIPTION DRUG ALDURAZYME laronidase INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20030430 BLA BLA125058 Genzyme Corporation LARONIDASE 2.9 mg/5mL alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC] 58468-0080_e4060f6a-76db-4deb-9f5a-ef622532e479 58468-0080 HUMAN PRESCRIPTION DRUG Thymoglobulin Anti-thymocyte Globulin (Rabbit) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19981230 BLA BLA103869 Genzyme Corporation LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN 5 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 58468-0100_e3f5bdd9-455f-4b62-94c0-4565d3121c55 58468-0100 HUMAN PRESCRIPTION DRUG Clolar clofarabine INJECTION INTRAVENOUS 20041228 NDA NDA021673 Genzyme Corporation CLOFARABINE 1 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 58468-0120_5dd79673-1791-4567-90bf-a31807e2f4e7 58468-0120 HUMAN PRESCRIPTION DRUG Hectorol doxercalciferol CAPSULE, LIQUID FILLED ORAL 20090803 NDA NDA020862 Genzyme Corporation DOXERCALCIFEROL .5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] 58468-0121_5dd79673-1791-4567-90bf-a31807e2f4e7 58468-0121 HUMAN PRESCRIPTION DRUG Hectorol doxercalciferol CAPSULE, LIQUID FILLED ORAL 20090803 NDA NDA020862 Genzyme Corporation DOXERCALCIFEROL 2.5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] 58468-0123_123706d5-6795-4a11-a6aa-83ffdee602d6 58468-0123 HUMAN PRESCRIPTION DRUG Hectorol DOXERCALCIFEROL INJECTION, SOLUTION INTRAVENOUS 20081208 NDA NDA021027 Genzyme Corporation DOXERCALCIFEROL 4 ug/2mL Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] 58468-0124_5dd79673-1791-4567-90bf-a31807e2f4e7 58468-0124 HUMAN PRESCRIPTION DRUG Hectorol DOXERCALCIFEROL CAPSULE, LIQUID FILLED ORAL 20090803 NDA NDA020862 Genzyme Corporation DOXERCALCIFEROL 1 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] 58468-0126_123706d5-6795-4a11-a6aa-83ffdee602d6 58468-0126 HUMAN PRESCRIPTION DRUG Hectorol DOXERCALCIFEROL INJECTION, SOLUTION INTRAVENOUS 20081208 NDA NDA021027 Genzyme Corporation DOXERCALCIFEROL 2 ug/mL Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] 58468-0127_123706d5-6795-4a11-a6aa-83ffdee602d6 58468-0127 HUMAN PRESCRIPTION DRUG Hectorol DOXERCALCIFEROL INJECTION, SOLUTION INTRAVENOUS 20081208 NDA NDA021027 Genzyme Corporation DOXERCALCIFEROL 4 ug/2mL Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] 58468-0130_a9d308cb-f1e5-4f2a-a5d5-6ce1ec0ee55b 58468-0130 HUMAN PRESCRIPTION DRUG Renvela SEVELAMER CARBONATE TABLET, FILM COATED ORAL 20090812 NDA NDA022127 Genzyme Corporation SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 58468-0131_a9d308cb-f1e5-4f2a-a5d5-6ce1ec0ee55b 58468-0131 HUMAN PRESCRIPTION DRUG Renvela SEVELAMER CARBONATE POWDER, FOR SUSPENSION ORAL 20090812 NDA NDA022318 Genzyme Corporation SEVELAMER CARBONATE 2400 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 58468-0132_a9d308cb-f1e5-4f2a-a5d5-6ce1ec0ee55b 58468-0132 HUMAN PRESCRIPTION DRUG Renvela SEVELAMER CARBONATE POWDER, FOR SUSPENSION ORAL 20090812 NDA NDA022318 Genzyme Corporation SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 58468-0140_2b6cc6a4-9e7b-4066-9936-e23a753b7547 58468-0140 HUMAN PRESCRIPTION DRUG Mozobil PLERIXAFOR SOLUTION SUBCUTANEOUS 20081215 NDA NDA022311 Genzyme Corporation PLERIXAFOR 24 mg/1.2mL Hematopoietic Stem Cell Mobilizer [EPC],Increased Hematopoietic Stem Cell Mobilization [PE] 58468-0150_d5c4c7bc-6ea9-43e9-83d4-09f842bb15e0 58468-0150 HUMAN PRESCRIPTION DRUG Myozyme ALGLUCOSIDASE ALFA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100619 BLA BLA125141 Genzyme Corporation ALGLUCOSIDASE ALFA 5 mg/mL alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC] 58468-0160_8720fd3f-9272-41a9-89ee-e452fa74187b 58468-0160 HUMAN PRESCRIPTION DRUG Lumizyme ALGLUCOSIDASE ALFA INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100524 BLA BLA125291 Genzyme Corporation ALGLUCOSIDASE ALFA 5 mg/mL alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC] 58468-0180_4c805287-5661-452a-91c6-da688bebc400 58468-0180 HUMAN PRESCRIPTION DRUG Leukine sargramostim INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100315 20160630 BLA BLA103362 Genzyme Corporation SARGRAMOSTIM 250 ug/mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] 58468-0190_f90158c9-a0f7-4ffa-94d5-83bfdc315f7c 58468-0190 HUMAN PRESCRIPTION DRUG Kynamro MIPOMERSEN SODIUM INJECTION, SOLUTION SUBCUTANEOUS 20130129 NDA NDA203568 Genzyme Corporation MIPOMERSEN SODIUM 200 mg/mL 58468-0191_f90158c9-a0f7-4ffa-94d5-83bfdc315f7c 58468-0191 HUMAN PRESCRIPTION DRUG Kynamro MIPOMERSEN SODIUM INJECTION, SOLUTION SUBCUTANEOUS 20130129 NDA NDA203568 Genzyme Corporation MIPOMERSEN SODIUM 200 mg/mL 58468-0200_26ec6adb-b2a1-4480-80f6-2d81311ddb5f 58468-0200 HUMAN PRESCRIPTION DRUG LEMTRADA ALEMTUZUMAB INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20141118 BLA BLA103948 Genzyme Corporation ALEMTUZUMAB 12 mg/1.2mL CD52-directed Antibody Interactions [MoA],CD52-directed Cytolytic Antibody [EPC] 58468-0210_5e60844f-4df2-485a-a71c-135021def5cc 58468-0210 HUMAN PRESCRIPTION DRUG Aubagio teriflunomide TABLET, FILM COATED ORAL 20130501 20541231 NDA NDA202992 Genzyme Corp. TERIFLUNOMIDE 14 mg/1 Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA] 58468-0211_5e60844f-4df2-485a-a71c-135021def5cc 58468-0211 HUMAN PRESCRIPTION DRUG Aubagio teriflunomide TABLET, FILM COATED ORAL 20130501 20541231 NDA NDA202992 Genzyme Corp. TERIFLUNOMIDE 7 mg/1 Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA] 58468-0220_7887c191-03db-4a18-9dea-b3907d0e9856 58468-0220 HUMAN PRESCRIPTION DRUG Cerdelga eliglustat CAPSULE ORAL 20140903 NDA NDA205494 Genzyme Corporation ELIGLUSTAT 84 mg/1 58468-0357_d986d7b0-b2f5-48d7-af39-f01669bc674f 58468-0357 HUMAN PRESCRIPTION DRUG Campath ALEMTUZUMAB INJECTION INTRAVENOUS 20091130 BLA BLA103948 Genzyme Corporation ALEMTUZUMAB 30 mg/mL CD52-directed Antibody Interactions [MoA],CD52-directed Cytolytic Antibody [EPC] 58468-1025_4e992833-70ee-4307-9d51-5a351ed92e9d 58468-1025 CELLULAR THERAPY Carticel autologous cultured chondrocytes IMPLANT INTRA-ARTICULAR 19970822 BLA BLA103661 Genzyme Corporation AUTOLOGOUS CULTURED CHONDROCYTES 12000000 1/1 Autologous Cultured Cell [EPC],Cells, Cultured, Autologous [Chemical/Ingredient],Chondrocytes [Chemical/Ingredient] 58468-1849_b9da8016-40ba-4e81-85c8-911862339cee 58468-1849 HUMAN PRESCRIPTION DRUG Thyrogen THYROTROPIN ALFA KIT 19981130 NDA NDA020898 Genzyme Corporation 58468-1983_c07ea20e-36bc-4f7b-a218-d79927f7c77e 58468-1983 HUMAN PRESCRIPTION DRUG Cerezyme IMIGLUCERASE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19940523 NDA NDA020367 Genzyme Corporation IMIGLUCERASE 40 U/mL Glucosylceramidase [Chemical/Ingredient],Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC] 58468-4663_c07ea20e-36bc-4f7b-a218-d79927f7c77e 58468-4663 HUMAN PRESCRIPTION DRUG Cerezyme IMIGLUCERASE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19940523 NDA NDA020367 Genzyme Corporation IMIGLUCERASE 40 U/mL Glucosylceramidase [Chemical/Ingredient],Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC] 58474-010_b833d43f-8157-4dac-b1a1-7df839da87f2 58474-010 HUMAN OTC DRUG PURE HYDROGEL MASK PACK Glycerin PATCH TOPICAL 20130301 OTC MONOGRAPH FINAL part347 WOOIL C&TECH.CORP GLYCERIN 7.5 g/30g 58474-020_7ea58976-00d5-4005-9f8e-676a2c65c869 58474-020 HUMAN OTC DRUG PURE HYDROGEL APPLE ZONE Glycerin PATCH TOPICAL 20130301 OTC MONOGRAPH FINAL part347 WOOIL C&TECH.CORP GLYCERIN 7.5 g/30g 58479-000_f2b8a3b4-163f-49b4-b27e-14c05f7bd98d 58479-000 HUMAN OTC DRUG GODDESS GARDEN ORGANICS Grapefruit Bergamot DAILY BROAD SPECTRUM SPF 15 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 37; 30 mg/mL; mg/mL 58479-001_a5b16812-2bea-4a9b-8b35-ab6651944b79 58479-001 HUMAN OTC DRUG GODDESS GARDEN ORGANICS Lavender Mint DAILY BROAD SPECTRUM SPF 15 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 37; 30 mg/mL; mg/mL 58479-002_8aa2e507-2e57-4a99-a414-29a7db5ee027 58479-002 HUMAN OTC DRUG GODDESS GARDEN ORGANICS Tangerine Lavender DAILY BROAD SPECTRUM SPF 15 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 37; 30 mg/mL; mg/mL 58479-003_339c2f26-7b92-4bc1-9082-b84846957d58 58479-003 HUMAN OTC DRUG GODDESS GARDEN ORGANICS Sunny Baby NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT ZINC OXIDE LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden ZINC OXIDE 190 mg/mL 58479-004_46ccb677-c2a3-4e37-a0f2-97443689ec1b 58479-004 HUMAN OTC DRUG GODDESS GARDEN ORGANICS Sunny Face NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 64; 60 mg/mL; mg/mL 58479-005_f1843b9e-e877-42c5-bb3c-afd4af0199f8 58479-005 HUMAN OTC DRUG GODDESS GARDEN ORGANICS Sunny Body NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 64; 60 mg/mL; mg/mL 58479-006_c863bb70-5bd2-48ea-b35c-3303add1420e 58479-006 HUMAN OTC DRUG GODDESS GARDEN ORGANICS Sunny Body NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 64; 60 mg/mL; mg/mL 58479-007_0eb34767-7cd5-44da-be65-a77108baa70a 58479-007 HUMAN OTC DRUG GODDESS GARDEN ORGANICS Sunny Kids NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 64; 60 mg/mL; mg/mL 58479-008_ab60f66c-2370-4bf4-be47-e11845e6fb3f 58479-008 HUMAN OTC DRUG GODDESS GARDEN ORGANICS Sunny Kids NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 64; 60 mg/mL; mg/mL 58479-009_ab66f064-15fa-445a-9cf6-c8821ca71c5d 58479-009 HUMAN OTC DRUG Goddess Garden Organics Everyday Natural Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SPRAY TOPICAL 20141212 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 64; 60 mg/mL; mg/mL 58479-010_ca8ab0bd-4306-42fb-8e66-e012870bde23 58479-010 HUMAN OTC DRUG Goddess Garden Organics Everyday Natural Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20141212 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 64; 60 mg/mL; mg/mL 58479-011_15dfb278-f5e9-4c82-b9d1-4f492ed2a4ec 58479-011 HUMAN OTC DRUG Goddess Garden Organics Kids Natural Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SPRAY TOPICAL 20141212 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 64; 60 mg/mL; mg/mL 58479-012_94628045-3a2a-426a-b1bc-a94501ad1877 58479-012 HUMAN OTC DRUG Goddess Garden Organics Kids Natural Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20141212 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 64; 60 mg/mL; mg/mL 58481-000_660a6fc7-44c5-45f6-b11b-9e9cee3884dc 58481-000 HUMAN OTC DRUG SESSION SAVERS SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130624 OTC MONOGRAPH NOT FINAL part352 Session Savers Sunscreen LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL 58484-100_e912b891-a457-4224-8a5b-7b7cb2b9a268 58484-100 HUMAN OTC DRUG Mr Dudleys Topical Pain Relief Menthol CREAM TOPICAL 20130513 OTC MONOGRAPH NOT FINAL part348 DUDLEY WELLNESS COMPANY INC MENTHOL 2.5 g/100g 58484-200_2b2b2e5d-ad74-4d36-ac5a-615a027bc5cc 58484-200 HUMAN OTC DRUG Mr Dudleys Topical Cycle Relief with Nutmeg Menthol CREAM TOPICAL 20131024 OTC MONOGRAPH NOT FINAL part348 Dudley Wellness Company Inc MENTHOL 2.5 g/100g 58488-001_cc7a8cf6-b04a-43d7-8c34-58f6cb9f6628 58488-001 HUMAN OTC DRUG Benzalkonium Chloride Antiseptic benzalkonium chloride SWAB TOPICAL 20130520 OTC MONOGRAPH NOT FINAL part333A Tongzhou Ruihong Medical Products Factory BENZALKONIUM CHLORIDE .0013 mg/1 58488-002_983f5871-26af-43fc-874d-413a300b5e60 58488-002 HUMAN OTC DRUG STING RELIEF MEDICATED PAD Benzocaine SWAB TOPICAL 20130520 OTC MONOGRAPH FINAL part333B Tongzhou Ruihong Medical Products Factory BENZOCAINE .06 mg/1 58488-003_b8a6302d-5125-43ff-8df6-e168fc0f8681 58488-003 HUMAN OTC DRUG Povidone-Iodine Prep Pad Povidone-Iodine SWAB PERCUTANEOUS 20130520 OTC MONOGRAPH FINAL part333C Tongzhou Ruihong Medical Products Factory POVIDONE-IODINE 10 mg/1 58488-004_eec0f085-69b7-4a62-b020-e53ee5ad50de 58488-004 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20130520 OTC MONOGRAPH NOT FINAL part333A Tongzhou Ruihong Medical Products Factory ISOPROPYL ALCOHOL .7 mL/1 58488-005_4d498475-be49-4480-9303-5d1cdcc31a61 58488-005 HUMAN OTC DRUG Cleansing Towelette benzalkonium chloride SWAB TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part333A Tongzhou Ruihong Medical Products Factory BENZALKONIUM CHLORIDE .13 mg/1 58488-006_9ef84712-e6fc-4a27-b9d8-b4e926b8256e 58488-006 HUMAN OTC DRUG Povidone-Iodine Solution Povidone-Iodine SOLUTION PERCUTANEOUS 20140520 OTC MONOGRAPH FINAL part333C Tongzhou Ruihong Medical Products Factory POVIDONE-IODINE .01 mg/g 58494-001_98fd8047-81b1-4f0e-9a68-750b12ee5f24 58494-001 HUMAN OTC DRUG Face Stockholm BB Natural Beauty Balm SPF 30 Shade NR 1 OCTINOXATE, TITANIUM DIOXIDE, ZINC DIOXIDE CREAM TOPICAL 20130515 OTC MONOGRAPH NOT FINAL part352 Face Stockholm OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 20; 128; 49 mg/mL; mg/mL; mg/mL 58494-002_88fa4a71-8d76-4d4e-affc-645783ed4e30 58494-002 HUMAN OTC DRUG Face Stockholm BB Natural Beauty Balm SPF 30 Shade NR 2 OCTINOXATE, TITANIUM DIOXIDE, ZINC DIOXIDE CREAM TOPICAL 20130515 OTC MONOGRAPH NOT FINAL part352 Face Stockholm OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 20; 128; 49 mg/mL; mg/mL; mg/mL 58496-600_17c51ed1-e9c0-40f4-b0e8-f2928277e9e5 58496-600 HUMAN OTC DRUG Instant Hand Sanitizer Convenience Pack ALCOHOL KIT 20130606 OTC MONOGRAPH NOT FINAL part333A Harmon Stores Inc 58496-601_b6a95592-4290-4497-8fd9-b59ce978fd24 58496-601 HUMAN OTC DRUG Instant Hand Sanitizer ALCOHOL GEL TOPICAL 20130606 OTC MONOGRAPH NOT FINAL part333A Harmon Stores Inc ALCOHOL 620 mg/mL 58503-005_9a845e13-c296-4b88-9be4-d271dc5f81b8 58503-005 HUMAN OTC DRUG Hand Sanitizer with Moisturizers Ethyl Alcohol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 147 mL/237mL 58503-006_2af683f1-8bb5-446f-8238-c4a253f43ff7 58503-006 HUMAN OTC DRUG Hand Sanitizer with Moisturizers Vitamin E and Aloe Ethyl Alcohol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 147 mL/237mL 58503-007_1e8a6da6-bd29-4ce0-8054-875f94dd4dcb 58503-007 HUMAN OTC DRUG Ice Cold Topical Analgesic Gel Menthol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part348 China Ningbo Shangge Cosmetic Technology Corp. MENTHOL 2.84 mg/227mg 58503-008_51566386-0205-44cc-9562-59629e75951b 58503-008 HUMAN OTC DRUG Hand Cleanse Refill Triclosan GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 7.5 mg/500mg 58503-009_3156b981-0261-4753-93ff-19e966d26c65 58503-009 HUMAN OTC DRUG Hand Cleanse Triclosan GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 7.5 mg/500mg 58503-012_8c5a97d5-7776-4dc6-b726-a2c0e4b0efd4 58503-012 HUMAN OTC DRUG Instant Hand Sanitizer Aloe Vera Ethyl Alcohol GEL TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 146 mL/236mL 58503-013_79cf4c1d-076c-42a6-9ea5-d63132d2c09a 58503-013 HUMAN OTC DRUG Instant Hand Sanitizer - Ice Clear Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 37 mL/60mL 58503-014_0c487774-e999-4991-9eb8-2ab1aa456eaf 58503-014 HUMAN OTC DRUG Instant Hand Sanitizer - Clear Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 147 mL/237mL 58503-015_8f397343-492b-40f9-8cee-a0624f10eb40 58503-015 HUMAN OTC DRUG Instant Hand Sanitizer - Cocoa Butter Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 147 mL/237mL 58503-016_2164da49-7fa0-4c7c-9b52-d3ecd74e20ef 58503-016 HUMAN OTC DRUG Liquid Hand Cleanse Triclosan GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 10 mg/500mg 58503-017_654a9d26-02fb-43b7-b587-e120391fc370 58503-017 HUMAN OTC DRUG Instant Hand Sanitizer - Original Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 33 mL/53mL 58503-018_b82e2808-963b-4699-b2b9-232c8d2718f2 58503-018 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 6 mL/10mL 58503-019_cdfdaa56-6396-4e63-97f3-057301b82ee7 58503-019 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Fresh Citrus Triclosan SOAP TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 3.3 mg/221mL 58503-020_9e19996c-f78a-4e55-873e-3c0d0f3ab389 58503-020 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Mountain Spring Triclosan SOAP TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 3.3 mg/221mL 58503-021_b1bc20ff-e574-4ea7-97af-7e1a88e214cb 58503-021 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Original Triclosan SOAP TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 3.3 mg/221mL 58503-022_0fce83f9-452d-42e6-b4b1-917edd6452e7 58503-022 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Original Triclosan SOAP TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 6.6 1/443mL 58503-023_4a73639f-41d4-4377-b728-33f3de37da86 58503-023 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Strawberry Pomegranate Triclosan SOAP TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 3.3 mg/221mL 58503-024_e399908f-2858-4103-9f47-45023c3d1a8b 58503-024 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse Cocoa and Shea Butter PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. PYRITHIONE ZINC 20 mg/400mg 58503-025_7a2e7d33-7601-43de-90c6-5a5102d9e470 58503-025 HUMAN OTC DRUG XtraCare Anti-Dandruff Conditioner Coconut and Shea Butter PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. PYRITHIONE ZINC 20 mg/400mg 58503-026_b181d3be-f6e2-430f-8417-ff71c3451244 58503-026 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse mint and eucalyptus PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. PYRITHIONE ZINC 20 mg/400mg 58503-027_1d84d629-5310-437b-8148-43e529f4c36d 58503-027 HUMAN OTC DRUG XtraCare Anti-Dandruff Conditioner mint and eucalyptus PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. PYRITHIONE ZINC 20 mg/400mg 58503-028_08d0b7c5-e198-4252-b711-ca25fbf3e816 58503-028 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse for normal hair PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. PYRITHIONE ZINC 20 mg/400mg 58503-029_f84a96eb-1f77-4db4-8ad7-eef08c9822bf 58503-029 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse for sensitive hair PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. PYRITHIONE ZINC 20 mg/400mg 58503-030_c356c30e-4f24-4d38-97e0-42215f600d22 58503-030 HUMAN OTC DRUG Acne Body Wash Salicylic Acid GEL TOPICAL 20131118 OTC MONOGRAPH FINAL part333D China Ningbo Shangge Cosmetic Technology Corp. SALICYLIC ACID 7 mg/354mg 58503-031_cc33e442-6ffb-41e6-b7be-7f7e1670b3db 58503-031 HUMAN OTC DRUG Oil-Free Foaming Acne Wash Salicylic Acid GEL TOPICAL 20131118 OTC MONOGRAPH FINAL part333D China Ningbo Shangge Cosmetic Technology Corp, SALICYLIC ACID 3 g/150g 58503-032_10a10256-c219-448b-9cbe-195ef980b2ff 58503-032 HUMAN OTC DRUG Oil-Free Foaming Acne Wash Tea Tree Oil Salicylic Acid GEL TOPICAL 20131120 OTC MONOGRAPH FINAL part333D China Ningbo Shangge Cosmetic Technology Corp. SALICYLIC ACID 3 g/150g 58503-033_033ad923-de3b-44e1-a13f-7a7667fc49b1 58503-033 HUMAN OTC DRUG Oil-Free Foaming Acne Wash Facial Cleanser Grapefruit Salicylic Acid GEL TOPICAL 20131121 OTC MONOGRAPH FINAL part333D China Ningbo Shangge Cosmetic Technology Corp. SALICYLIC ACID 4 mg/177mg 58503-034_4636591a-8a1e-46d4-b6c6-ecd58aa8349b 58503-034 HUMAN OTC DRUG Oil-Free Foaming Acne Wash Facial Cleanser Tea Tree Oil Salicylic Acid GEL TOPICAL 20131121 OTC MONOGRAPH FINAL part333D China Ningbo Shangge Cosmetic Technology Corp. SALICYLIC ACID 4 mg/177mg 58503-036_01d43cbc-c9ef-4ed9-bba0-217bc0b34e32 58503-036 HUMAN OTC DRUG XtraCare Foaming Facial Cleanser Triclosan GEL TOPICAL 20131126 OTC MONOGRAPH NOT FINAL part333A China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 1 mg/237mg 58503-037_8ad50949-ea26-4952-94ab-ce0d11483c26 58503-037 HUMAN OTC DRUG XtraCare Skin Relief Oatmeal Daily Moisturizing Dimethicone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp. DIMETHICONE 5 mg/354mg 58503-038_6669ea40-565f-4bb6-babd-3cd28d2de0be 58503-038 HUMAN OTC DRUG XtraCare with cooling action Oatmeal Skin Relief Calmin Dimethicone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp. DIMETHICONE 5 mg/354mg 58503-039_4ad70d1d-4125-4e3e-bba1-038f6e11099f 58503-039 HUMAN OTC DRUG XtraCare Creamy Petroleum Jelly Cocoa Butter Enriched Petroleum CREAM TOPICAL 20140124 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp. PETROLATUM 59 g/198g 58503-040_a289768b-3a13-43d1-b6c3-1d7f69e0818a 58503-040 HUMAN OTC DRUG XtraCare Creamy Petroleum Jelly Vitamin E enriched Petrolatum CREAM TOPICAL 20140124 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp PETROLATUM 59 g/198g 58503-041_709ccbe3-7379-4524-bcc5-3df74b631364 58503-041 HUMAN OTC DRUG XtraCare Dry Fresh Invisible Solid Aluminum Chlorohydrate CREAM TOPICAL 20140124 OTC MONOGRAPH FINAL part350 China Ningbo Shangge Cosmetic Technology Corp. ALUMINUM CHLOROHYDRATE 11 g/57g 58503-042_204eee9f-577c-4f4f-a5ad-f99e67c77bd1 58503-042 HUMAN OTC DRUG XtraCare Invisible Solid Lady Stick Powder Fresh Aluminum Chlorohydrate CREAM TOPICAL 20140124 OTC MONOGRAPH FINAL part350 China Ningbo Shangge Cosmetic Technology Corp. ALUMINUM CHLOROHYDRATE 11 g/57g 58503-043_805e382b-d193-4a06-bb93-91fcd9cc947f 58503-043 HUMAN OTC DRUG XtraCare Hand Sanitizer Moisturize with Vitamin E Ethyl Alcohol GEL TOPICAL 20140124 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp ALCOHOL 146 g/236g 58503-044_466186bb-badf-4f5b-b679-bdf64d0b4988 58503-044 HUMAN OTC DRUG XtraCare Hand Sanitizer Moisurize with Vitamin E and Aloe Ethyl Alcohol GEL TOPICAL 20140124 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp ALCOHOL 146 g/236g 58503-045_2e6b0a1b-c1fa-4680-8fca-b00d95c0954e 58503-045 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower Benzalkonium Chloride LIQUID TOPICAL 20140124 OTC MONOGRAPH NOT FINAL part333A China Ningbo Shangge Cosmetic Technology Corp BENZALKONIUM CHLORIDE .5 g/444g 58503-046_9dafa31b-f982-492c-bf4c-b2b330136034 58503-046 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Refill Wild Berry Blast Benzalkonium Chloride SOAP TOPICAL 20140128 OTC MONOGRAPH NOT FINAL part333A China Ningbo Shangge Cosmetic Technology Corp. BENZALKONIUM CHLORIDE .5 g/444g 58503-047_b0b1bca9-95f2-45b4-ae0f-7b6bdc782347 58503-047 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower Benzalkonium Chloride SOAP TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A China Ningbo Shangge Cosmetic Technology Corp, BENZALKONIUM CHLORIDE .2 g/221g 58503-048_cd9699ae-5087-4da2-8f5c-6303848b2be7 58503-048 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Wild Berry Blast Benzalkonium Chloride SOAP TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A China Ningbo Shangge Cosmetic Technology Corp BENZALKONIUM CHLORIDE .2 g/221g 58503-049_34aaf9ec-69f0-49a9-a300-987a6dbfea7d 58503-049 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Pink Cherry Blossom Benzalkonium Chloride SOAP TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A China Ningbo Shangge Cosmetic Technology Corp. BENZALKONIUM CHLORIDE .2 g/221g 58503-050_66d5a935-a9ef-4bca-91f1-f7a73d447154 58503-050 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry Blossom Benzalkonium Chloride SOAP TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A China Ningbo Shangge Cosmetic Technology Corp. BENZALKONIUM CHLORIDE .5 g/444g 58503-051_c50914e0-6ede-47c2-a522-92fb3ddd2ed4 58503-051 HUMAN OTC DRUG XtraCare Vaporizing Chest Rub Camphor, Menthol GEL TOPICAL 20140130 OTC MONOGRAPH FINAL part341 China Ningbo Shangge Cosmetic Technology Corp. CAMPHOR (NATURAL); MENTHOL 5; 1 g/113g; g/113g 58503-052_11c0101a-919d-41cc-b759-be3fc358a00f 58503-052 HUMAN OTC DRUG XtraCare Ice Cold Topical Analgesic Gel Menthol GEL TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part348 China Ningbo Shangge Cosmetic Technology Corp MENTHOL 3 g/227g 58503-053_6bd8be29-7da4-46f1-b051-7b18c73a74d3 58503-053 HUMAN OTC DRUG XtraCare Dandruff Hair Wash Salicylic Acid SHAMPOO TOPICAL 20140205 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. SALICYLIC ACID 10 g/325g 58503-054_35307038-2556-4c80-ae62-89279b6636bd 58503-054 HUMAN OTC DRUG XtraCare Skin Relief Oatmeal Daily Moisturizing Dimethicone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp. DIMETHICONE 3 g/227g 58503-055_99e4bae5-f58a-4b92-8608-dd7685368d45 58503-055 HUMAN OTC DRUG XtraCare with cooling action Oatmeal Skin Relief Calmin Dimethicone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp. DIMETHICONE 3 g/227g 58503-057_b374d394-31c9-4787-8ccf-794f06b24715 58503-057 HUMAN OTC DRUG XtraCare Foaming Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp BENZALKONIUM CHLORIDE 3 g/207g 58503-058_3f446e4c-a8da-46bd-b1b0-880ed0869bfa 58503-058 HUMAN OTC DRUG XtraCare Instant Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp ALCOHOL 37 g/60g 58503-059_4123fca9-f2b2-4b5e-8daa-d53b9fcdf7b4 58503-059 HUMAN OTC DRUG XtraCare Instant Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp ALCOHOL 37 g/60g 58503-060_0d13ae94-09c2-49ed-ac1b-cdcb44957062 58503-060 HUMAN OTC DRUG XtraCare Creamy Petroleum Jelly Petrolatum JELLY TOPICAL 20140218 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp PETROLATUM 38 g/127g 58503-061_065d5b9d-394f-4226-8201-e116a05cd181 58503-061 HUMAN OTC DRUG XtraCare Creamy Petroleum Jelly Petrolatum JELLY TOPICAL 20140218 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp PETROLATUM 38 g/127g 58503-062_81f5a20b-dc4d-44e0-84b5-a5d9b3643493 58503-062 HUMAN OTC DRUG XtraCare Wet Wipes Benzethonium Chloride SWAB TOPICAL 20140313 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp BENZETHONIUM CHLORIDE 3 mg/100mg 58503-063_87a77252-333a-4bb4-9938-b177935674d1 58503-063 HUMAN OTC DRUG Creamy Petroleum Jelly Petrolatum JELLY TOPICAL 20140819 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp. PETROLATUM 30 g/100g 58503-064_f5a1b140-8724-48f6-b8a7-e6750fdaad9e 58503-064 HUMAN OTC DRUG XtraCare 2 in 1 Hair Cleanse and Condition Coconut Water Pyrithione Zinc SHAMPOO TOPICAL 20140827 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. PYRITHIONE ZINC 2 g/100g 58503-065_386c807c-8de1-42e2-b843-bb6a2bb1ad45 58503-065 HUMAN OTC DRUG XtraCare 2 in 1 Hair Cleanse and Condition Green Apple Pyrithione Zinc SHAMPOO TOPICAL 20140827 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. PYRITHIONE ZINC 2 g/100g 58503-066_aaf901be-f1c3-4109-a1e7-511589af1483 58503-066 HUMAN OTC DRUG Wet Wipes benzethonium chloride CLOTH TOPICAL 20141208 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp BENZETHONIUM CHLORIDE .3 g/1 58503-067_ffd86e98-ea02-4963-ab07-8dbaa89ac03c 58503-067 HUMAN OTC DRUG Wet Wipes benzethonium chloride CLOTH TOPICAL 20141208 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp BENZETHONIUM CHLORIDE .3 g/1 58503-068_58bb9347-c56e-414a-b446-e57de22063a6 58503-068 HUMAN OTC DRUG Wet Wipes benzethonium chloride CLOTH TOPICAL 20141208 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp BENZETHONIUM CHLORIDE .3 g/1 58517-001_e8f80f38-13c2-4688-85d9-f99510e08d92 58517-001 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130825 ANDA ANDA090548 New Horizon Rx Group, LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 58517-020_f7e2081e-f97e-449a-a5e2-768ffcb931b4 58517-020 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE ORAL 20131231 ANDA ANDA076048 New Horizon Rx Group, LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 58517-040_462c8531-be91-4189-8471-e796777087a0 58517-040 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20130825 ANDA ANDA090564 New Horizon Rx Group, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 58517-060_01e45240-dc37-486b-8451-2b5e5a12cfdd 58517-060 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20130825 ANDA ANDA078787 New Horizon Rx Group, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 58517-080_e8799c4d-1d81-4e78-a29e-01b54c576d09 58517-080 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20130825 ANDA ANDA078218 New Horizon Rx Group, LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 58517-100_308c2e2e-f9ef-47e3-bacb-5e0f4fea5814 58517-100 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20130825 ANDA ANDA077534 New Horizon Rx Group, LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58517-120_57ff62d2-0f5d-4756-9d43-147efc7d6942 58517-120 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20130825 ANDA ANDA078477 New Horizon Rx Group, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 58517-140_c3e59ee7-b196-4088-8662-2f047c6e1216 58517-140 HUMAN PRESCRIPTION DRUG SULFAMETHOXAZOLE AND TRIMETHOPRIM double strength SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET ORAL 20130825 ANDA ANDA076899 New Horizon Rx Group, LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 58517-160_113e0540-bfcd-4d68-b128-c5cfc1ce938e 58517-160 HUMAN PRESCRIPTION DRUG paroxetine hydrochloride paroxetine hydrochloride TABLET ORAL 20130825 ANDA ANDA078902 New Horizon Rx Group, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 58517-200_17f863dd-1b47-4f2c-8893-fb06e09250ca 58517-200 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20130813 ANDA ANDA090121 New Horizon Rx Group, LLC FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 58517-220_a13d2414-c7fe-4202-9cb4-a78984cb1fba 58517-220 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET ORAL 20130825 ANDA ANDA090722 New Horizon Rx Group, LLC LEVOFLOXACIN 500 mg/1 58517-240_3457501e-f3b7-48df-a874-ab25db0a4797 58517-240 HUMAN PRESCRIPTION DRUG Losartan Potatssium Losartan Potatssium TABLET ORAL 20130825 ANDA ANDA078243 New Horizon Rx Group, LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 58517-260_5fb6a9a3-f4d5-4ad2-9457-4651aea4a82a 58517-260 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20130825 ANDA ANDA077927 New Horizon Rx Group, LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58517-300_75e40f0f-246e-457d-a4f4-8984a620feef 58517-300 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20130825 ANDA ANDA078432 New Horizon Rx Group, LLC NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 58517-320_982fdb28-f826-4203-81c6-958cb73083e9 58517-320 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET, FILM COATED ORAL 20130825 ANDA ANDA076704 New Horizon Rx Group, LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 58517-340_5cbda603-31ef-43b8-a650-015822a1e2aa 58517-340 HUMAN PRESCRIPTION DRUG BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET ORAL 20130825 ANDA ANDA074253 New Horizon Rx Group, LLC BUSPIRONE HYDROCHLORIDE 10 mg/1 58517-360_f7a32c82-ba7f-4c77-b3b2-f080afee9c6e 58517-360 HUMAN PRESCRIPTION DRUG warfarin sodium warfarin sodium TABLET ORAL 20130825 ANDA ANDA040663 New Horizon Rx Group, LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 58517-380_4ed0bea5-7cc0-4c59-9517-6628c53a27b4 58517-380 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20130825 ANDA ANDA076416 New Horizon Rx Group, LLC TIZANIDINE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 58517-400_fa87df49-449e-4062-be6e-6b85da718a1b 58517-400 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20130825 ANDA ANDA078010 New Horizon Rx Group, LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 58517-420_3488e3d7-1285-4002-b351-15f59623a2eb 58517-420 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM Delayed Release PANTOPRAZOLE SODIUM TABLET ORAL 20130825 ANDA ANDA077058 New Horizon Rx Group, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 58517-440_165688ef-8ccc-47c2-ae3e-4c6bf2dcb048 58517-440 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20130825 ANDA ANDA077068 New Horizon Rx Group, LLC BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 58518-010_04e26667-d23f-4fad-9fcb-04214015c78c 58518-010 HUMAN OTC DRUG ENVIRONMENTAL DEFENSE ZINC OXIDE CREAM TOPICAL 20130718 OTC MONOGRAPH NOT FINAL part352 Avasol ZINC OXIDE 225 mg/100mL 58518-020_a3bd6294-10df-4782-a64e-624abf171497 58518-020 HUMAN OTC DRUG SURFERS BARRIER ZINC OXIDE STICK TOPICAL 20130718 OTC MONOGRAPH NOT FINAL part352 Avasol ZINC OXIDE 24.5 g/100g 58543-1001_7dfe8436-37a1-4f35-929d-5ed6d692b1af 58543-1001 HUMAN OTC DRUG ENA Actimineral A CALCIUM LIQUID ORAL 20130628 UNAPPROVED DRUG OTHER Jinju Bio Food CALCIUM 803.8 mg/1000mL 58552-121_5529ff63-6458-4c4e-8145-74ad6b4666a8 58552-121 HUMAN OTC DRUG GILTUSS PEDIATRIC dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride SOLUTION/ DROPS ORAL 20091019 OTC MONOGRAPH FINAL part341 Gil Pharmaceutical Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 7.5; 88; 2.5 mg/mL; mg/mL; mg/mL 58552-122_f8f87c2a-bf82-4211-9969-92f77a3389ca 58552-122 HUMAN OTC DRUG Giltuss Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride SYRUP ORAL 20091019 OTC MONOGRAPH FINAL part341 Gil Pharmaceutical Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 28; 388; 10 mg/5mL; mg/5mL; mg/5mL 58552-127_d13554c2-8d41-43e5-80be-bf48d6dc0bce 58552-127 HUMAN OTC DRUG Carbaphen CH chlophedianol HCl, chlorpheniramine maleate, and phenylephrine SUSPENSION ORAL 20111229 OTC MONOGRAPH FINAL part341 Gil Pharmaceutical Corp CHLOPHEDIANOL HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 24; 4; 10 mg/5mL; mg/5mL; mg/5mL 58552-128_e01afa69-3911-4041-8256-71ac3e807a9c 58552-128 HUMAN OTC DRUG Carbaphen Ped CH Chlophedianol HCL, Chlorpheniramine Maleate and Phenylephrine HCl SUSPENSION ORAL 20120329 OTC MONOGRAPH FINAL part341 Gil Pharmaceutical Corp CHLOPHEDIANOL HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 8; 1.25; 2.5 mg/mL; mg/mL; mg/mL 58552-313_cd8c6362-a8dc-4c3b-bee9-cfe31b29437c 58552-313 HUMAN OTC DRUG Gilphex TR Guaifenesin and Phenylephrine HCl TABLET ORAL 20080212 OTC MONOGRAPH FINAL part341 Gil Pharmaceutical Corp GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 388; 10 mg/1; mg/1 58552-317_683e0694-a1e5-49f9-ba36-bcd67917be00 58552-317 HUMAN OTC DRUG GILTUSS TOTAL RELEASE Guaifenesin, Dextromethorphan HBr, and Phenylephrine HCl TABLET ORAL 20091019 OTC MONOGRAPH FINAL part341 Gil Pharmaceutical Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 28; 388; 10 mg/1; mg/1; mg/1 58554-0002_90c06bdc-5dc1-4555-88e4-fbc8fcc1c26a 58554-0002 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 19910101 UNAPPROVED MEDICAL GAS Memorial Home Care OXYGEN 210 mL/L 58559-001_1f9feebc-001c-43cc-84ee-3587dc35c749 58559-001 HUMAN OTC DRUG Relief Pain Relieving Cream MENTHOL CREAM TOPICAL 20040522 OTC MONOGRAPH NOT FINAL part348 Corganics, LP MENTHOL 2.5 g/100g 58575-130_97f98819-9341-4680-b7c3-5065d68d3d8c 58575-130 HUMAN OTC DRUG DermaGel HAND SANITIZING ALCOHOL GEL TOPICAL 19900901 OTC MONOGRAPH NOT FINAL part333E Inopak. Ltd ALCOHOL 70 mL/100mL 58575-150_27fcd8d9-4c3a-4194-b7ef-580a56b6b909 58575-150 HUMAN OTC DRUG SaniGuard-SF ALCOHOL LIQUID TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333E Inopak. Ltd ALCOHOL 70 mL/100mL 58575-170_548d78dd-a2d8-435f-8d06-fbd7845fef1d 58575-170 HUMAN OTC DRUG AQUACIL BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333E Inopak, Ltd BENZALKONIUM CHLORIDE 100 mg/100mL 58578-0729_d96580fd-1958-4357-adc9-8f24ba0e83c0 58578-0729 HUMAN OTC DRUG CloSYS Sodium Fluoride PASTE, DENTIFRICE DENTAL; ORAL 20110315 OTC MONOGRAPH FINAL part355 Rowpar Pharmaceuticals, Inc. SODIUM FLUORIDE 1.1 mg/g 58590-001_0eef098b-3bd2-4641-afea-0f85fa2cdb00 58590-001 HUMAN OTC DRUG Hand Armor Benzalkonium Chloride LIQUID TOPICAL 20130904 OTC MONOGRAPH NOT FINAL part333E HyGenesis BENZALKONIUM CHLORIDE 1.3 mg/g 58593-225_15703e30-a6a5-4da1-b14f-1eafaa9507dd 58593-225 HUMAN OTC DRUG Rompe Pecho SF FLU Dextromethorphan, Brompheniramine Maleate, Phenylephrine Hydrochloride LIQUID ORAL 20071001 OTC MONOGRAPH FINAL part341 Efficient Laboratories Inc BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 10; 10; 10 mg/5mL; mg/5mL; mg/5mL 58593-235_91b4d4b9-9820-4731-bc15-331ca41f20e8 58593-235 HUMAN OTC DRUG Rompe Pecho CF Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL LIQUID ORAL 20071001 OTC MONOGRAPH FINAL part341 Efficient Laboratories Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 58593-245_ad13fb63-48f9-4342-9605-54dfe7dcff6c 58593-245 HUMAN OTC DRUG Rompe Pecho Guaifenesin LIQUID ORAL 19980101 OTC MONOGRAPH FINAL part341 Efficient Laboratories Inc GUAIFENESIN 100 mg/5mL 58593-255_cd0780bd-3de8-4037-b7ce-195150df8a87 58593-255 HUMAN OTC DRUG Cough Out Guaifenesin LIQUID ORAL 19970701 OTC MONOGRAPH FINAL part341 Efficient Laboratories Inc. GUAIFENESIN 100 mg/5mL 58593-265_ba6c53d1-e0d8-426f-a6a1-3ae96a05cf76 58593-265 HUMAN OTC DRUG Rompe Pecho SF Guaifenesin LIQUID ORAL 19990301 OTC MONOGRAPH FINAL part341 Efficient Laboratories, Inc. GUAIFENESIN 100 mg/5mL 58593-275_3719c16e-283f-4230-9a26-b4ebab59ebc8 58593-275 HUMAN OTC DRUG Rompe Pecho DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20011001 OTC MONOGRAPH FINAL part341 Efficient Laboratories Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 58593-285_b68ce0dd-01f4-4664-ae8c-fe235991675b 58593-285 HUMAN OTC DRUG Hongo Killer Tolnaftate AEROSOL, POWDER TOPICAL 20020301 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc TOLNAFTATE .1 g/10g 58593-286_1f233e04-ecb2-4c9f-9b24-b471c43a875d 58593-286 HUMAN OTC DRUG Hongo Killer Antifungal Tolnaftate CREAM TOPICAL 20000101 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc TOLNAFTATE .1 g/10g 58593-287_70544c7a-fc66-49e6-b35b-98258474f91a 58593-287 HUMAN OTC DRUG Hongo Killer Antifungal Tolnaftate CREAM TOPICAL 20000101 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc TOLNAFTATE .1 g/10g 58593-288_d49fcfcb-60ce-4f82-85f5-0d9c5cb0317c 58593-288 HUMAN OTC DRUG Hongo Killer Tolnaftate POWDER TOPICAL 20000101 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc TOLNAFTATE .1 g/10g 58593-295_34fb6db7-ddfc-48f2-9b57-0402834e98b0 58593-295 HUMAN OTC DRUG Mielim y mas Dextromethorphan LIQUID ORAL 19970201 OTC MONOGRAPH FINAL part341 Efficient Laboratories Inc. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 58593-600_987f5b6f-5b1a-4ffe-8316-f2e84c2bb982 58593-600 HUMAN OTC DRUG Hongo Killer Undecylenic Acid LIQUID TOPICAL 19910101 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc UNDECYLENIC ACID 1.1 mL/10mL 58593-601_8d116fe8-94c1-47bb-951d-b0959abf8872 58593-601 HUMAN OTC DRUG Hongo Killer undecylenic acid SPRAY TOPICAL 20130701 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc UNDECYLENIC ACID 2 mg/10mL 58593-625_a483cdc5-6264-43f5-824d-f9d2f6e6ef14 58593-625 HUMAN OTC DRUG Hongo Killer Tolnaftate AEROSOL, SPRAY TOPICAL 20041001 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc MICONAZOLE NITRATE .2 g/10g 58593-780_a5847ffe-2a7a-4187-86cd-f91f594de375 58593-780 HUMAN OTC DRUG Finafta Ethyl Alcohol, Salicylic Acid, Benzocaine LIQUID ORAL 19911001 OTC MONOGRAPH NOT FINAL part356 Efficient Laboratories Inc. ALCOHOL; BENZOCAINE; SALICYLIC ACID 60; 5; 1 mL/100mL; mg/100mL; mg/100mL 58593-781_10d0269a-5088-47cf-9e15-5d847cccef2d 58593-781 HUMAN OTC DRUG Finafta Baby Benzocaine LIQUID ORAL 20000101 OTC MONOGRAPH NOT FINAL part356 Efficient Laboratories Inc. BENZOCAINE 7.5 mg/100mg 58593-782_e1b58b61-f9f8-487b-b20d-012c6b781345 58593-782 HUMAN OTC DRUG Finafta MultiOral Benzocaine LIQUID ORAL 20040901 OTC MONOGRAPH FINAL part356 Efficient Laboratories Inc. BENZOCAINE 7.5 mL/100mL 58593-800_3d3a6ff2-112b-481f-bdd4-034930f539b3 58593-800 HUMAN OTC DRUG Ongo - Fin TOLNAFTATE LIQUID TOPICAL 20040201 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc. TOLNAFTATE 1 mL/100mL 58593-825_20bd3beb-5f46-492c-9624-3e5222163ad2 58593-825 HUMAN OTC DRUG Hongo Killer Undecylenic Acid SOLUTION TOPICAL 19910101 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc UNDECYLENIC ACID 1.1 mL/10mL 58593-826_e92d1f9e-2819-43a2-8904-019b287bbf93 58593-826 HUMAN OTC DRUG Hongo Killer Undecylenic Acid LIQUID TOPICAL 20120701 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc UNDECYLENIC ACID 25 mL/100mL 58593-827_6b482c26-99fe-4ead-964a-987171a0159e 58593-827 HUMAN OTC DRUG Zero Allergy Cetirizine Hydrochloride TABLET ORAL 20130401 ANDA ANDA077498 Efficient Laboratories Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 58596-001_8c27e165-93f9-43f2-9ec3-9e9a5e644cff 58596-001 HUMAN OTC DRUG Cough and Cold XL3 Xtra Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140731 OTC MONOGRAPH FINAL part341 Selgel Mexico, S.A. de C.V. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 250; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 58599-003_0c90365e-c06d-4368-b627-aac3c415ddd2 58599-003 HUMAN OTC DRUG DIPHENHYDRAMINE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20140731 OTC MONOGRAPH FINAL part341 PURINEPHARMA LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 58599-004_4924194e-5c66-4af3-b83a-5367a10248a2 58599-004 HUMAN OTC DRUG DIPHENHYDRAMINE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20140731 OTC MONOGRAPH FINAL part341 PURINEPHARMA LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 58602-023_9a855ca2-7613-49a8-bfe2-0a4012851890 58602-023 HUMAN OTC DRUG Aurodryl Childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 20140910 OTC MONOGRAPH FINAL part341 Aurohealth LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 58602-204_28884042-9fcc-4fb4-8ef0-9add2bd02a39 58602-204 HUMAN OTC DRUG Aurophen Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20140910 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/5mL 58602-422_52dc28ac-4059-4b6c-8bbc-22aa479a549a 58602-422 HUMAN OTC DRUG Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20100202 ANDA ANDA090750 Aurohealth LLC CETIRIZINE HYDROCHLORIDE 1 mg/mL 58605-150_79c81ee6-bae5-45b4-93c8-7b896a0975e3 58605-150 HUMAN OTC DRUG BroveX PSB Pseudoephedrine Hydrochloride and Brompheniramine Maleate LIQUID ORAL 20071130 OTC MONOGRAPH FINAL part341 MCR American Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 20 mg/5mL; mg/5mL 58605-151_b652e5a8-f339-4e39-b410-9e0857ffba3a 58605-151 HUMAN OTC DRUG BroveX PSB DM Pseudoephedrine Hydrochloride, Brompheniramine Maleate, and Dextromethorphan Hydrobromide LIQUID ORAL 20071130 OTC MONOGRAPH FINAL part341 MCR American Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 20; 20 mg/5mL; mg/5mL; mg/5mL 58605-152_004dd25b-e97b-4264-b664-b3fee1ec4022 58605-152 HUMAN OTC DRUG BroveX PEB Brompheniramine Maleate and Phenylephrine Hydrochloride LIQUID ORAL 20071130 OTC MONOGRAPH FINAL part341 MCR American Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/5mL; mg/5mL 58605-153_6c2d7ce5-af0f-4a67-af49-ebe16e165dd4 58605-153 HUMAN OTC DRUG BroveX PEB DM Brompheniramine Maleate, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide LIQUID ORAL 20071130 OTC MONOGRAPH FINAL part341 MCR American Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 20; 10 mg/5mL; mg/5mL; mg/5mL 58605-401_f8c0fb86-2639-485f-9eaf-769dc32e49ea 58605-401 HUMAN OTC DRUG Allfen DM GUAIFENESIN and Dextromethorphan Hydrobromide TABLET ORAL 20080331 OTC MONOGRAPH FINAL part341 MCR American Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 58605-422_688d38bc-8d53-4103-8041-9da8184b73b6 58605-422 HUMAN OTC DRUG Maxiphen GUAIFENESIN and Phenylephrine Hydrochloride TABLET ORAL 20080331 OTC MONOGRAPH FINAL part341 MCR American Pharmaceuticals, Inc. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 58605-423_1a720629-daee-4f54-b8ed-6d0d69c9d1cd 58605-423 HUMAN OTC DRUG Maxiphen DM Guaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide TABLET ORAL 20080331 OTC MONOGRAPH FINAL part341 MCR American Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/1; mg/1; mg/1 58607-111_4f445831-63ec-4b5f-9135-a3074f518fcc 58607-111 HUMAN OTC DRUG Myferon 150 IRON SUCROSE CAPSULE ORAL 19961201 UNAPPROVED DRUG OTHER MARTIN EKWEALOR PHARMACEUTICALS, INC. IRON SUCROSE 150 mg/1 58607-112_24af9e28-be37-44a7-89c9-629f29b621e9 58607-112 HUMAN PRESCRIPTION DRUG Myferon 150 Forte IRON SUCROSE, FOLIC ACID, CYANOCOBALAMIN CAPSULE ORAL 19961201 UNAPPROVED DRUG OTHER MARTIN EKWEALOR PHARMACEUTICALS, INC. CYANOCOBALAMIN; FOLIC ACID; IRON SUCROSE 25; 1; 150 ug/1; mg/1; mg/1 Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 58607-113_07283557-cfb0-4689-8e9e-a0dd5c061fda 58607-113 HUMAN OTC DRUG FERROUS SULFATE FERROUS SULFATE TABLET ORAL 20140901 UNAPPROVED DRUG OTHER MARTIN EKWEALOR PHARMACEUTICALS, INC. CALCIUM; FERROUS SULFATE 20; 65 mg/1; mg/1 58607-186_2e082773-b3e5-4e5c-a1ca-058bcc4ae0e7 58607-186 HUMAN PRESCRIPTION DRUG MYNEPHROCAPS DIALYSIS/STRESS Vitamin Supplement ASCORBIC ACID, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CALCIUM PANTOTHENATE, THIAMINE MONONITRATE, FOLIC ACID, BIOTIN, CYANOCOBALAMIN CAPSULE ORAL 20131216 UNAPPROVED DRUG OTHER MARTIN EKWEALOR PHARMACEUTICALS, INC. ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE 100; 150; 5; 6; 1; 20; 10; 1.7; 1.5 mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 58607-700_7622102b-138b-4991-91dd-72eeeb58f2b8 58607-700 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 NF PEGyLAX POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20131216 UNAPPROVED DRUG OTHER MARTIN EKWEALOR PHARMACEUTICALS, INC. POLYETHYLENE GLYCOL 3350 17 g/17g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 58611-032_d7f5f9f3-3c8f-4e48-ba98-3928d754019a 58611-032 HUMAN OTC DRUG Phoenix KinetiCream Anti-inflammatory and Pain Relief MENTHOL CREAM TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part348 Phoenix Bioperformance Products, LLC MENTHOL 20 mg/mL 58633-223_264ee8f1-7679-4e47-8d49-4d43d54e18dd 58633-223 HUMAN OTC DRUG Correct and Perfect Spot Treatment Sulfur CREAM TOPICAL 20060905 OTC MONOGRAPH FINAL part333D Dr. Dennis Gross Skincare, LLC SULFUR 32.5 mg/g 58633-231_dce8bb6d-1d82-44d8-8d63-a7740a6fce83 58633-231 HUMAN OTC DRUG CC SPF 18 Fair avobenzone, octinoxate CREAM TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part352 Dr. Dennis Gross Skincare, LLC AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL 58633-232_dce8bb6d-1d82-44d8-8d63-a7740a6fce83 58633-232 HUMAN OTC DRUG CC SPF 18 Light to Medium avobenzone, octinoxate CREAM TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part352 Dr. Dennis Gross Skincare, LLC AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL 58633-233_dce8bb6d-1d82-44d8-8d63-a7740a6fce83 58633-233 HUMAN OTC DRUG CC SPF 18 Medium avobenzone, octinoxate CREAM TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part352 Dr. Dennis Gross Skincare, LLC AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL 58633-234_dce8bb6d-1d82-44d8-8d63-a7740a6fce83 58633-234 HUMAN OTC DRUG CC SPF 18 Medium to Dark avobenzone, octinoxate CREAM TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part352 Dr. Dennis Gross Skincare, LLC AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL 58633-269_4036d87e-e4a0-455e-9368-241fcffa1117 58633-269 HUMAN OTC DRUG Clarifying Colloidal Sulfur Mask sulfur CREAM TOPICAL 20120801 OTC MONOGRAPH FINAL part333D Dr. Dennis Gross Skincare, LLC SULFUR 50 mg/g 58657-100_0cccf426-6a68-44a4-a9ea-f0234908f334 58657-100 HUMAN PRESCRIPTION DRUG PreFol-DHA Folic Acid, Ascorbic Acid, Calcium, Iron, Cholecalciferol, .Alpha.-Tocopherol, D-, Pyridoxine Hydrochloride, Doconexent, Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20131001 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC .ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CALCIUM; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON; PYRIDOXINE HYDROCHLORIDE 30; 28; 160; 400; 300; 55; 1.2; 26; 25 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 58657-105_dca8f6e0-a2a9-4139-a043-bb1cfd24c073 58657-105 HUMAN PRESCRIPTION DRUG Focalgin B Pyridoxine Hydrochloride, Folic Acid, Calcium, and Ginger TABLET, FILM COATED ORAL 20131101 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC CALCIUM; FOLIC ACID; GINGER; PYRIDOXINE HYDROCHLORIDE 124.23; 1.22; 100; 42 mg/1; mg/1; mg/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 58657-401_6b2935b1-1267-4865-adb8-9726ffb66780 58657-401 HUMAN PRESCRIPTION DRUG Isometheptene-Dichloral-APAP Oral Isometheptene Mucate, Dichloralphenazone, and Acetaminophen CAPSULE ORAL 20140904 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC ACETAMINOPHEN; DICHLORALPHENAZONE; ISOMETHEPTENE MUCATE 325; 100; 65 mg/1; mg/1; mg/1 CIV 58657-410_65591f29-0b17-46b6-9600-0654a8a72bdc 58657-410 HUMAN PRESCRIPTION DRUG Sodium Citrate-Citric Acid Trisodium Citrate Dihydrate and Citric Acid Monohydrate SOLUTION ORAL 20141020 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 334; 500 mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 58657-411_8765cac3-b50c-4fd8-b744-7b9b01b4b637 58657-411 HUMAN PRESCRIPTION DRUG Potassium Citrate-Sodium Citrate-Citric Acid Potassium Citrate, Trisodium Citrate Dihydrate and Citric Acid Monohydrate SOLUTION ORAL 20141020 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC CITRIC ACID MONOHYDRATE; POTASSIUM CITRATE; TRISODIUM CITRATE DIHYDRATE 334; 550; 500 mg/5mL; mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 58657-412_6167bf45-3d21-4400-9861-5b1d1ea199ee 58657-412 HUMAN PRESCRIPTION DRUG Potassium Citrate-Citric Acid Potassium Citrate and Citric Acid Monohydrate SOLUTION ORAL 20141020 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC CITRIC ACID MONOHYDRATE; POTASSIUM CITRATE 334; 1100 mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 58657-420_24546cf1-a567-4148-8b72-f59746e90da6 58657-420 HUMAN PRESCRIPTION DRUG Me-PB-Hyos Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide ELIXIR ORAL 20140601 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] CIV 58657-421_d74273b6-ebea-41e6-8976-6115719023d5 58657-421 HUMAN PRESCRIPTION DRUG Me-PB-Hyos Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide TABLET ORAL 20140601 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 58657-425_7cc4baa9-ff2d-46b9-b5a7-959c7521211d 58657-425 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate ELIXIR ORAL 20141101 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC HYOSCYAMINE SULFATE .125 mg/5mL 58657-426_ea10be9d-60a1-48ae-a9f9-f56a4ee3f9b0 58657-426 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate SOLUTION ORAL 20141201 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC HYOSCYAMINE SULFATE .125 mg/mL 58657-450_2402991a-4884-4c03-ae0d-9108bf7b50e3 58657-450 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl 100mg Phenazopyridine Hydrochloride TABLET ORAL 20141020 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 58657-451_371b2eff-5e00-4896-bd72-9c983fe5bcd9 58657-451 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl 200mg Phenazopyridine Hydrochloride TABLET ORAL 20141020 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 58657-455_26112ef0-2f72-463c-804e-4f214076c0f3 58657-455 HUMAN PRESCRIPTION DRUG Uro-BLUE Methenamine, Sodium Phosphate, Monobasic, Methylene Blue and Hyoscyamine Sulfate TABLET ORAL 20141201 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; SODIUM PHOSPHATE, MONOBASIC .12; 81.6; 10.8; 40.8 mg/1; mg/1; mg/1; mg/1 58657-456_83902306-9968-4e65-8065-607aa1008e5b 58657-456 HUMAN PRESCRIPTION DRUG Uro-MP Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate CAPSULE ORAL 20141201 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS .12; 118; 10; 36; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1 58657-457_103b8f01-22a0-4c0c-b547-4fa2ed93e4da 58657-457 HUMAN PRESCRIPTION DRUG Uro-L Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate TABLET ORAL 20141201 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS .12; 81; 10.8; 32.4; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1 58657-480_06280831-24bd-4044-8507-531b2f34ef84 58657-480 HUMAN PRESCRIPTION DRUG Antipyrine and Benzocaine Otic Antipyrine and Benzocaine SOLUTION AURICULAR (OTIC) 20141201 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC ANTIPYRINE; BENZOCAINE 55; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 58657-500_c02dcf14-b878-4f97-89a0-ec9f8a6617e6 58657-500 HUMAN OTC DRUG Codeine-Guaifenesin Codeine Phosphate and Guaifenesin SOLUTION ORAL 20140401 OTC MONOGRAPH FINAL part341 Method Pharmaceuticals, LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 58662-0001_87e82d98-5eb8-468e-80dc-848d793f3716 58662-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20140804 NDA NDA205840 Home Medical Products & Services, LLC OXYGEN 1 L/L 58665-001_b5fc2894-982e-4360-b0d6-d2e2b6661e55 58665-001 HUMAN OTC DRUG freshnails the undernail sanitizer Isopropyl Alcohol LIQUID TOPICAL 20131119 OTC MONOGRAPH NOT FINAL part333A TWB Strategic Investments Inc. ISOPROPYL ALCOHOL .7 mL/mL 58666-3121_412e9df6-f046-4d33-894b-dc77a62ce893 58666-3121 HUMAN OTC DRUG Inflammation Therapy CALENDULA OFFICINALIS FLOWERING TOP SOAP TOPICAL 20130601 UNAPPROVED HOMEOPATHIC Sundial Group LLC CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g 58666-3122_62adc9c2-9915-4de3-9713-2c13b1b6fecc 58666-3122 HUMAN OTC DRUG Eczema and Psoriasis Therapy FUCUS VESICULOSUS, CENTELLA ASIATICA, MELISSA OFFICINALIS, ALOE SOAP TOPICAL 20130601 UNAPPROVED HOMEOPATHIC Sundial Group LLC ALOE; CENTELLA ASIATICA; FUCUS VESICULOSUS; MELISSA OFFICINALIS 1; 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 58668-0100_f28edb77-0bc5-44c1-839b-5f9e70b5be5e 58668-0100 HUMAN OTC DRUG UV PLUS HP ECRAN MULTI-PROTECTION BROAD SPECTRUM SPF 40 Titanium Dioxide - MULTI-PROTECTION (S2033B) TITANIUM DIOXIDE LOTION TOPICAL 20141112 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 81 mg/mL 58668-0105_65a79016-0f79-4de2-b358-7511e1548997 58668-0105 HUMAN OTC DRUG BB SKIN PERFECTING BROAD SPECTRUM SPF 25 Titanium Dioxide - Sunscreen - Shade Light 01 TITANIUM DIOXIDE CREAM TOPICAL 20141118 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 47 mg/mL 58668-0106_c4e47c7f-383c-4f03-8733-12fa80b19ae3 58668-0106 HUMAN OTC DRUG BB SKIN PERFECTING BROAD SPECTRUM SPF 25 Titanium Dioxide - Sunscreen - Shade Medium 02 TITANIUM DIOXIDE CREAM TOPICAL 20141118 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 47 mg/mL 58668-0107_73514f7d-988f-4e94-9605-9d0b2c2fab3e 58668-0107 HUMAN OTC DRUG BB SKIN PERFECTING BROAD SPECTRUM SPF 25 Titanium Dioxide - Sunscreen - Shade Dark 03 TITANIUM DIOXIDE CREAM TOPICAL 20141118 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 47 mg/mL 58668-0191_271db5e4-48d4-4a6b-aa03-6197019c346a 58668-0191 HUMAN OTC DRUG Thierry Mugler Womanity Antiperspirant Roll-On Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20110401 OTC MONOGRAPH FINAL part350 Laboratoires Clarins S.A. ALUMINUM CHLOROHYDRATE 20 mL/100mL 58668-0351_4dd8150f-d151-4e3a-a963-2948fb86007f 58668-0351 HUMAN OTC DRUG CLARINS MEN UV Protection SPF 40 TITANIUM DIOXIDE LIQUID TOPICAL 20111005 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 9.45 mL/100mL 58668-0581_0c7e48d5-36af-44e2-85d4-a6b3b249b8fe 58668-0581 HUMAN OTC DRUG Clarins Advanced Extra-Firming Day OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20100721 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2.5; 7.5; 5; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 58668-0679_244a4ccb-bde0-4489-9dbb-7b13f4ac3348 58668-0679 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Titanium Dioxide-Sunscreen Extra-Firming Foundation Tint 105 TITANIUM DIOXIDE LIQUID TOPICAL 20140916 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL 58668-0681_daa27211-89a5-4ea1-97c5-6dd8060b41ca 58668-0681 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra Firming Day Wrinkle Lifting AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130220 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 27 mg/mL; mg/mL; mg/mL; mg/mL 58668-0701_017a0043-f990-43a4-843b-444e2a9652c5 58668-0701 HUMAN OTC DRUG Clarins Super Restorative Day OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, OXYBENZONE, ENSULIZOLE CREAM TOPICAL 20100723 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 1; 1; 1; 1; 1 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 58668-0731_d154dea6-ae57-46cd-a9ff-6e3ad7140bf9 58668-0731 HUMAN OTC DRUG Super Restorative Tinted SPF 20 Tint 1 TITANIUM DIOXIDE CREAM TOPICAL 20110108 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 7.4 mL/100mL 58668-0741_0f5ff1e2-8598-447c-91a9-66946f368d42 58668-0741 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 20 Super Restorative Tinted Tint 02 TITANIUM DIOXIDE CREAM TOPICAL 20130219 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 70 mg/mL 58668-0751_798aba46-b10b-4605-86b0-258b0c7472e9 58668-0751 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 20 Super Restorative Tinted Tint 03 TITANIUM DIOXIDE CREAM TOPICAL 20130219 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 70 mg/mL 58668-0761_d14f06f6-c6cd-4ebe-abd4-2c2a77552b17 58668-0761 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 20 Super Restorative Tinted Tint 04 TITANIUM DIOXIDE CREAM TOPICAL 20130219 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 68 mg/mL 58668-0771_a7b6d768-cc4c-44c6-889b-71666839e38c 58668-0771 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 20 Super Restorative Tinted Tint 05 TITANIUM DIOXIDE CREAM TOPICAL 20130219 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 63 mg/mL 58668-0961_62b25c7e-0c36-4d66-9f22-3ea5a95a3ab9 58668-0961 HUMAN OTC DRUG CLARINS Super Restorative Day Illuminating lifting replenishing BROAD SPECTRUM - SPF 20 - Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE CREAM TOPICAL 20130729 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTOCRYLENE 30; 100; 27 mg/mL; mg/mL; mg/mL 58668-1031_31da3082-d971-4db8-a0c8-e631d869b842 58668-1031 HUMAN OTC DRUG Multi-Active Day Early Wrinkle Correcting SPF 15 OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20110402 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2.5; 7.5; 5; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 58668-1070_e173e3d9-d94c-47c2-9267-5968c5c7716a 58668-1070 HUMAN OTC DRUG CLARINS SUPER RESTORATIVE DAY BROAD SPECTRUM SPF 20 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTOCRYLENE CREAM TOPICAL 20130418 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTOCRYLENE 30; 100; 27 mg/mL; mg/mL; mg/mL 58668-1103_95f22d9f-9670-4ced-9a8f-81f49bdc12d6 58668-1103 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 15 - Sunscreen Multi-Active Day Early wrinkle correcting AVOBENZONE, HOMOSALATE, OCTOCRYLENE LOTION TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTOCRYLENE 30; 50; 27 mg/mL; mg/mL; mg/mL 58668-1139_e8773b8e-6b91-4854-8f03-8d25a5b18996 58668-1139 HUMAN OTC DRUG CLARINS HydraQuench Normal to Dry Skin Broad Spectrum SPF 15 Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE CREAM TOPICAL 20101001 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A AVOBENZONE; HOMOSALATE; OCTOCRYLENE 3; 5; 2.7 mL/100mL; mL/100mL; mL/100mL 58668-1140_e5ac17fb-9d24-4f71-a82b-24aa3a85d5ff 58668-1140 HUMAN OTC DRUG CLARINS HydraQuench Normal to Combination Skin Broad Spectrum SPF 15 Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE LOTION TOPICAL 20121003 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A AVOBENZONE; HOMOSALATE; OCTOCRYLENE 3; 5; 2.7 mL/100mL; mL/100mL; mL/100mL 58668-1211_72cfc8f8-787a-48e8-86e3-07093ad6a5a9 58668-1211 HUMAN OTC DRUG Fluide Fondant Desalterant SPF 15 Hydra Quench - Formula B OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20100716 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2.5; 7.5; 5; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 58668-1218_61d72e64-167a-43b0-aa7a-02fc31b3f59e 58668-1218 HUMAN OTC DRUG CLARINS Bright Plus HP SPF 20 Brightening Hydrating Day OCTINOXATE, ENSULIZOLE, OCTISALATE, AVOBENZONE LOTION TOPICAL 20100302 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; ENSULIZOLE; OCTINOXATE; OCTISALATE 2; 2.8; 7.5; 2.5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 58668-1261_71beb601-37d1-4b48-8f91-2d9680dd8d2b 58668-1261 HUMAN OTC DRUG Clarins HydraQuench SPF 15 OCTINOXATE, OCTISALATE CREAM TOPICAL 20110402 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. OCTINOXATE; OCTISALATE 7.5; 5 mL/50mL; mL/100mL 58668-1321_13fe39a3-344b-40d3-b10a-221ab2a481aa 58668-1321 HUMAN OTC DRUG Super Restorative Foundation True Lift SPF 15 Tint 2.5 TITANIUM DIOXIDE CREAM TOPICAL 20110417 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 2.5 mL/100mL 58668-1331_a2f2c8f2-8ecc-4929-b2db-1672bc66284c 58668-1331 HUMAN OTC DRUG Super Restorative Foundation True Lift SPF 15 Tint 03 TITANIUM DIOXIDE CREAM TOPICAL 20110417 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 2.5 mL/100mL 58668-1351_305741a1-976f-43f2-b96c-f8ea1bf69cec 58668-1351 HUMAN OTC DRUG Super Restorative Foundation True Lift SPF 15 Tint 06 TITANIUM DIOXIDE CREAM TOPICAL 20110417 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 2.5 mL/100mL 58668-1361_72534107-5688-494b-bf97-3849b3fa8eb1 58668-1361 HUMAN OTC DRUG Super Restorative Foundation True Lift SPF 15 Tint 6.5 TITANIUM DIOXIDE CREAM TOPICAL 20110417 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 2.5 mL/100mL 58668-1371_56083bf1-5b0e-45c5-a3a9-080c6abe8837 58668-1371 HUMAN OTC DRUG Super Restorative Foundation True Lift SPF 15 Tint 07 TITANIUM DIOXIDE CREAM TOPICAL 20110417 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 2.5 mL/100mL 58668-1381_fb517bd2-9405-4a39-b749-0ef0f5cb9c86 58668-1381 HUMAN OTC DRUG Super Restorative Foundation True Lift SPF 15 Tint 7.5 TITANIUM DIOXIDE CREAM TOPICAL 20110417 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 2.5 mL/100mL 58668-1391_84eeb902-3214-4f7d-a069-f8d34c677bea 58668-1391 HUMAN OTC DRUG Super Restorative Foundation True Lift SPF 15 Tint 08 TITANIUM DIOXIDE CREAM TOPICAL 20110417 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 2.5 mL/100mL 58668-1401_b2da8846-c649-48bb-a0a8-6e23251d52e2 58668-1401 HUMAN OTC DRUG Super Restorative Foundation True Lift SPF 15 Tint 09 TITANIUM DIOXIDE CREAM TOPICAL 20110417 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 2.5 mL/100mL 58668-1409_2ab1feca-52a4-43f6-b8e8-d5babb5e82c3 58668-1409 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 30 Sunscreen Care AVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENE,OXYBENZONE CREAM TOPICAL 20131217 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 27; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58668-1501_b2f62639-5cbb-44f5-a1e1-d51ee0e21819 58668-1501 HUMAN OTC DRUG CLARINS HydraQuench Tinted Moisturizer Broad Spectrum SPF 6 01 NATUREL TITANIUM DIOXIDE EMULSION TOPICAL 20121025 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 30 mg/mL 58668-1511_fa8afa64-9047-40c8-9d9d-2947aa8a2820 58668-1511 HUMAN OTC DRUG CLARINS HydraQuench Tinted Moisturizer Broad Spectrum SPF 6 02 BEIGE TITANIUM DIOXIDE EMULSION TOPICAL 20121025 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 30 mg/mL 58668-1521_66428369-8224-46ec-ba81-88f114f2c107 58668-1521 HUMAN OTC DRUG CLARINS HydraQuench Tinted CLARINS HydraQuench Tinted Moisturizer Broad Spectrum SPF 6 03 PEACH TITANIUM DIOXIDE EMULSION TOPICAL 20121025 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 30 mg/mL 58668-1641_85872959-3d65-40b4-aa2e-2a377ec11c5a 58668-1641 HUMAN OTC DRUG Clarins Vital Light Day SPF 15 HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20100930 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 2.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 58668-1931_37501fc2-b4b8-422d-b58f-9d499d1fb965 58668-1931 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Titanium Dioxide-Sunscreen Extra-Firming Foundation Tint 103 TITANIUM DIOXIDE LIQUID TOPICAL 20140916 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL 58668-1941_392f4179-6736-4e3c-af69-c1aa287360a1 58668-1941 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 104 TITANIUM DIOXIDE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL 58668-1971_a5f22042-83b1-4842-8afc-6c88efbe26fc 58668-1971 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 107 TITANIUM DIOXIDE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL 58668-1981_33190611-2409-4dc1-94c7-a865d508b0a4 58668-1981 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 108 TITANIUM DIOXIDE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL 58668-1991_202351f1-edda-4864-b647-e4925b6a48b1 58668-1991 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 109 TITANIUM DIOXIDE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL 58668-2001_a0a3ab60-01f4-4fbf-9380-526a09a71523 58668-2001 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 110 TITANIUM DIOXIDE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL 58668-2011_20899840-d7d2-4961-abe0-b22a013a2eb9 58668-2011 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 111 TITANIUM DIOXIDE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL 58668-2021_9f5723b1-2959-40f7-884b-60749175555e 58668-2021 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 112 TITANIUM DIOXIDE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL 58668-2031_02fb4863-976c-4e2c-838c-7f9bd2eeff6d 58668-2031 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 113 TITANIUM DIOXIDE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL 58668-2041_613a1e17-1210-44ca-9f99-145a2e2b1deb 58668-2041 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 114 TITANIUM DIOXIDE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL 58668-2131_ddc1f9a5-652e-4842-8162-9dcd72f2d5d7 58668-2131 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 103 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL 58668-2141_9bea57ff-0eb9-46d6-b52e-30acbd7e85a3 58668-2141 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 104 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL 58668-2151_35afa24b-8b70-45de-bb6f-3975ba7b216f 58668-2151 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 105 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL 58668-2171_39d517b8-7f5b-4e2f-aafd-9b06420efb0d 58668-2171 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 107 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL 58668-2181_9115b7b3-eda4-4607-ae9b-d3654fb00f4f 58668-2181 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 108 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL 58668-2191_95571c8e-af52-42a9-aa3b-2cadc62df4a3 58668-2191 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 109 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL 58668-2201_249cd57a-8949-436f-853a-790951e41532 58668-2201 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 110 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL 58668-2211_ed8d4fdc-331b-4687-b2d6-7c5095b9eff9 58668-2211 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 111 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL 58668-2221_2a71bf46-bce5-4267-b8f9-6191c4df34aa 58668-2221 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 112 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL 58668-2231_60994c74-ebf2-4bc3-af05-a14b018c5af0 58668-2231 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 113 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL 58668-2241_bc8762d2-1f93-4bb2-b113-70636816d0e5 58668-2241 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 114 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL 58668-2261_3b918e28-6f53-48df-982a-464a897dcbec 58668-2261 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 116 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL 58668-2271_456e2bec-21dc-4328-ab76-5215a2a988a7 58668-2271 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 117 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL 58668-2281_016c86e8-6a1c-4520-88f9-992f579f3b96 58668-2281 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 118 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL 58668-2511_6e6fc043-8f36-481c-8819-f64766f11369 58668-2511 HUMAN OTC DRUG Clarins Rouge Hydra Nude - 01 Nude Rose OCTINOXATE LIPSTICK TOPICAL 20100709 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. OCTINOXATE 5 g/100g 58668-2521_51450d93-54a2-4daa-a076-42b151b728ae 58668-2521 HUMAN OTC DRUG Clarins Rouge Hydra Nude - 02 Nude Coral OCTINOXATE LIPSTICK TOPICAL 20100709 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. OCTINOXATE 5 g/100g 58668-2531_0da34c7d-7b48-43b7-a560-500a32f5bea7 58668-2531 HUMAN OTC DRUG Clarins Rouge Hydra Nude - 03 Nude Beige OCTINOXATE LIPSTICK TOPICAL 20100709 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. OCTINOXATE 5 g/100g 58668-2541_0a66151e-0110-4e11-a7c6-72edfbd5cda3 58668-2541 HUMAN OTC DRUG Clarins Rouge Hydra Nude - 04 Nude Caramel OCTINOXATE LIPSTICK TOPICAL 20100709 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. OCTINOXATE 5 g/100g 58668-2561_f3242ed7-0cd2-4155-aeae-f66b8e671cec 58668-2561 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 112.5 TITANIUM DIOXIDE LIQUID TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL 58668-2571_c376e1fc-b8d0-45cb-bf2a-685796235dd0 58668-2571 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 115 TITANIUM DIOXIDE LIQUID TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL 58668-2581_c3ba3dce-96b8-4dc7-9d15-3933a1db5b66 58668-2581 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 116.5 TITANIUM DIOXIDE LIQUID TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL 58668-2591_f5dba5c5-ced3-43ec-b8f7-7900a7e8aa82 58668-2591 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 117 TITANIUM DIOXIDE LIQUID TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL 58668-2601_931721b8-2faf-4664-a8c7-69a268f357f3 58668-2601 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 118 TITANIUM DIOXIDE LIQUID TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL 58668-2631_fbf93966-cc80-4edc-8bfe-c03c3e710a45 58668-2631 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 103 TITANIUM DIOXIDE LIQUID TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL 58668-2641_959f1ab5-3e5f-4fcc-b613-5dac2274d7c2 58668-2641 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 104 TITANIUM DIOXIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL 58668-2651_d31f8557-0630-47ee-8e77-ef07abc5795d 58668-2651 HUMAN OTC DRUG CLARINS SKIN ILLUSION Mineral and Plant Extracts SPF 10 Titanium Dioxide- Sunscreen - Natural Radiance Foundation Tint 105 TITANIUM DIOXIDE LIQUID TOPICAL 20140916 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL 58668-2671_335d57d5-109b-4070-a87e-cf181ae1e157 58668-2671 HUMAN OTC DRUG Clarins Paris Skin Illusion - 107 Beige TITANIUM DIOXIDE LIQUID TOPICAL 20100624 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 1.89 mL/100mL 58668-2671_ba01ed5c-5b98-417c-ae6a-cb68208ac2a6 58668-2671 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 107 TITANIUM DIOXIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL 58668-2681_c0a215e4-5588-4b87-8c08-e53a5e175791 58668-2681 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 108 TITANIUM DIOXIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL 58668-2691_3141adc7-9e0a-462c-9c35-4aa8decabe30 58668-2691 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 109 TITANIUM DIOXIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL 58668-2701_e009b562-f02e-4e25-916b-112e3b822fc2 58668-2701 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 110 TITANIUM DIOXIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL 58668-2711_ef541d67-e750-4baa-b8cc-6d2e4058b222 58668-2711 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 111 TITANIUM DIOXIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL 58668-2721_1e3ee963-91e2-4645-ba25-db89accd3d65 58668-2721 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 112 TITANIUM DIOXIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL 58668-2731_e4819a72-6440-443e-b6d4-e0c885cce51a 58668-2731 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 113 TITANIUM DIOXIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL 58668-2741_60387db3-bc0e-4ee0-b3c8-092f72ffda1d 58668-2741 HUMAN OTC DRUG Clarins Paris Skin Illusion - 114 cappuccino TITANIUM DIOXIDE LIQUID TOPICAL 20100624 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 1.89 mL/100mL 58668-2741_d108b7ca-c60d-43a0-a6d8-ca7bcc289218 58668-2741 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 114 TITANIUM DIOXIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL 58668-2771_9c6b1b16-a5d0-47f2-9ffd-8c0c8633f1fb 58668-2771 HUMAN OTC DRUG CLARINS Ever Matte SPF 15 - 103 Ivory TITANIUM DIOXIDE CREAM TOPICAL 20111031 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 2.3 mL/100mL 58668-2781_75b38f2c-4121-4d7c-99ff-bff08ee9555b 58668-2781 HUMAN OTC DRUG CLARINS Ever Matte Broad Spectrum SPF 15 Tint 104 TITANIUM DIOXIDE CREAM TOPICAL 20121011 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 23 mg/mL 58668-2791_b30bbd80-ed5d-484a-a2b4-7f404e52dad6 58668-2791 HUMAN OTC DRUG CLARINS Ever Matte SPF 15 - 105 Nude TITANIUM DIOXIDE CREAM TOPICAL 20111031 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 2.3 mL/100mL 58668-2811_89c8d313-25ff-42ec-877f-1d35dfd6ec38 58668-2811 HUMAN OTC DRUG CLARINS Ever Matte Broad Spectrum SPF 15 Tint 107 TITANIUM DIOXIDE CREAM TOPICAL 20121011 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 23 mg/mL 58668-2821_92e093d4-e634-4950-91d4-8a801a944041 58668-2821 HUMAN OTC DRUG CLARINS Ever Matte Broad Spectrum SPF 15 Tint 108 TITANIUM DIOXIDE CREAM TOPICAL 20121011 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 23 mg/mL 58668-2831_ed0f9c35-1a1f-4245-969a-4dd909f24ca1 58668-2831 HUMAN OTC DRUG CLARINS Ever Matte Broad Spectrum SPF 15 Tint 109 TITANIUM DIOXIDE CREAM TOPICAL 20121011 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 23 mg/mL 58668-2832_eba2228b-d207-4161-8b96-6d9b5fe38b31 58668-2832 HUMAN OTC DRUG UV PLUS HP DAY SCREEN HIGH PROTECTION TITANIUM DIOXIDE EMULSION TOPICAL 20100319 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 8.1 mL/100mL 58668-2841_e80d0409-7899-42cd-b0ed-d4b6bb6d7b7f 58668-2841 HUMAN OTC DRUG CLARINS Ever Matte Broad Spectrum SPF 15 Tint 110 TITANIUM DIOXIDE CREAM TOPICAL 20121011 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 23 mg/mL 58668-2851_cc7df7a1-42d3-482a-84bf-63f54db28c94 58668-2851 HUMAN OTC DRUG CLARINS Ever Matte Broad Spectrum SPF 15 Tint 111 TITANIUM DIOXIDE CREAM TOPICAL 20121011 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 23 mg/mL 58668-2861_b7bd52fb-1dc0-49ec-aac6-6e53260cf269 58668-2861 HUMAN OTC DRUG CLARINS Ever Matte Broad Spectrum SPF 15 Tint 112 TITANIUM DIOXIDE CREAM TOPICAL 20121011 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 23 mg/mL 58668-2871_28e93af0-be3b-46e5-8e67-fa4e507ea268 58668-2871 HUMAN OTC DRUG CLARINS Ever Matte Broad Spectrum SPF 15 Tint 113 TITANIUM DIOXIDE CREAM TOPICAL 20121011 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 23 mg/mL 58668-2872_59379cff-a888-4862-a1d2-82843d7490bd 58668-2872 HUMAN OTC DRUG Clarins UV Plus HP SPF 40 Day Screen High Protection TITANIUM DIOXIDE LIQUID TOPICAL 20100930 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 8.1 mL/100mL 58668-2881_92d1d7cb-d27b-4bdd-8728-941acfbe7ca8 58668-2881 HUMAN OTC DRUG CLARINS Ever Matte Broad Spectrum SPF 15 Tint 114 TITANIUM DIOXIDE CREAM TOPICAL 20121011 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 23 mg/mL 58668-2901_0c89def7-5872-4992-adc9-a8cbf2aefcbb 58668-2901 HUMAN OTC DRUG CLARINS UV PLUS HP Broad Spectrum SPF 40 Sunscreen Multi-Protection Tint LIGHT TITANIUM DIOXIDE LIQUID TOPICAL 20121025 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 70 mg/mL 58668-2911_83978f14-fd36-42f5-8131-e70231869f4e 58668-2911 HUMAN OTC DRUG CLARINS UV PLUS HP Broad Spectrum SPF 40 Sunscreen Multi-Protection Tint MEDIUM TITANIUM DIOXIDE LIQUID TOPICAL 20121025 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 70 mg/mL 58668-2921_7c14131a-cd72-4ff1-bf5d-24bdb842bda4 58668-2921 HUMAN OTC DRUG CLARINS UV PLUS HP Broad Spectrum SPF 40 Sunscreen Multi-Protection Tint DEEP TITANIUM DIOXIDE LIQUID TOPICAL 20121025 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 81 mg/mL 58668-2951_5a8aef01-3289-45f1-9aa7-7f8488b45eda 58668-2951 HUMAN OTC DRUG CLARINS UV PLUS ANTI-POLLUTION BROAD SPECTRUM SPF 50 NON-TINTED Sunscreen Multi-Protection HOMOSALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20140916 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. HOMOSALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 40; 40; 150; 109 mg/mL; mg/mL; mg/mL; mg/mL 58668-3251_806e72fd-a14a-40f0-aecf-ce0f12a3ca7f 58668-3251 HUMAN OTC DRUG CLARINS Daily Energizer SPF 15 OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20110113 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2.5; 7.5; 5; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 58668-4001_65c0ebe4-e7db-4abd-acdf-c32b65a11e4c 58668-4001 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 15 - SUNSCREEN FOR FACE WRINKLE CONTROL AVOBENZONE, HOMOSALATE, OCTOCRYLENE CREAM TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTOCRYLENE 30; 50; 27 mg/mL; mg/mL; mg/mL 58668-4011_4d69ee0f-a9c2-4624-9de8-92974f92687a 58668-4011 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 30 Sunscreen For Face Wrinkle Control AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20130306 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 27; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58668-4021_fb03c290-3c20-4e82-a517-74ebebd610b4 58668-4021 HUMAN OTC DRUG Clarins Broad Spectrum SPF 30 Sunscreen for Sun-Sensitive Areas TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20120927 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE; ZINC OXIDE 9.7; 3.8 g/100g; g/100g 58668-4031_bf8d276f-600b-4a32-a0f8-75ccbf8b5bd8 58668-4031 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 50 Plus - SUNSCREEN FOR FACE WRINKLE CONTROL AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 27; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58668-4061_75842323-d46a-478a-a066-3aadb6a439b4 58668-4061 HUMAN OTC DRUG Clarins Broad Spectrum SPF 15 Sunscreen Care For Outdoor Sports AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SPRAY TOPICAL 20131023 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 27 mg/mL; mg/mL; mg/mL; mg/mL 58668-4071_ed2cfac7-a45b-4a2a-a26b-1e7957c9f683 58668-4071 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 20 - SUNSCREEN CARE MILK AVOBENZONE, HOMOSALATE, OCTOCRYLENE SPRAY TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTOCRYLENE 30; 100; 27 mg/mL; mg/mL; mg/mL 58668-4081_c64489b9-da2b-410a-90f6-6fabaaa202ce 58668-4081 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 20 - SUNSCREEN CARE AVOBENZONE, HOMOSALATE, OCTOCRYLENE CREAM TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTOCRYLENE 30; 100; 27 mg/mL; mg/mL; mg/mL 58668-4091_1283834c-43bd-4f97-9c14-8f12ccabe678 58668-4091 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 30 - SUNSCREEN CARE AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 27; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58668-4101_e3d4c854-65d5-42cb-9e90-fda0122d878a 58668-4101 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 50 Plus - SUNSCREEN CARE MILK AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 27; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58668-4111_d0d4e894-f4db-4323-b16f-cabe5e02abc1 58668-4111 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 50 SUNSCREEN CARE MILK FOR CHILDREN TITANIUM DIOXIDE, ZINC OXIDE LIQUID TOPICAL 20130506 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE; ZINC OXIDE 146; 58 mg/mL; mg/mL 58668-4221_b5bd1f4c-9510-4eab-a44a-b164bf4a92e2 58668-4221 HUMAN OTC DRUG Clarins Sunscreen Wrinkle Control Moderate Protection SPF 15 OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 7; 2.05 mL/100mL; mL/100mL; mL/100mL 58668-4251_08d8e283-df47-44f4-a341-4d5e7e5f1b76 58668-4251 HUMAN OTC DRUG Clarins Sunscreen For Eyes Wrinkle Control SPF 30 UVA/UVB TITANIUM DIOXIDE CREAM TOPICAL 20101019 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mL/100mL 58668-4281_5c5a18d7-4698-494c-9fee-40347f811bc5 58668-4281 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 15 SUNSCREEN DELECTABLE SELF TANNING MOUSSE AVOBENZONE, OCTISALATE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20130506 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 25; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL 58668-4451_03b9ecc6-1254-4c0f-a3fc-364c7e433678 58668-4451 HUMAN OTC DRUG Clarins Sunscreen Smoothing Rapid Tanning SPF10 OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE GEL TOPICAL 20100805 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2.5; 7.5; 5; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 58668-4531_358bd8ff-e1d6-4537-86b6-2869d92dc489 58668-4531 HUMAN OTC DRUG Clarins Sunscreen Care Radiant SPF 6 UVB/UVA OCTINOXATE, AVOBENZONE SPRAY TOPICAL 20101019 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; OCTINOXATE 3; 7.5 mL/100mL; mL/100mL 58668-4541_8d237211-be00-4077-a4fb-61981c55d655 58668-4541 HUMAN OTC DRUG Clarins Sunscreen Care Milk- SPF 50 Plus HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE SPRAY TOPICAL 20101019 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.7; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 58668-4551_8ce9720f-1573-48a6-ab69-398e9f97c966 58668-4551 HUMAN OTC DRUG CLARINS HIGH PROTECTION SUNSCREEN CARE MILK FOR CHILDREN SPF 50 TITANIUM DIOXIDE, ZINC OXIDE LIQUID TOPICAL 20111018 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE; ZINC OXIDE 15.6; 5.8 mL/100mL; mL/100mL 58668-4561_5e73ba32-16ef-4798-b951-8f8cb08b6e07 58668-4561 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 30 SUNSCREEN CARE AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20130711 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 27; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58668-4571_ba9dbc92-3232-4573-8bdc-80a31c5c44ed 58668-4571 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Care For Outdoor Sports AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20130228 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 75; 50; 20; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58668-5061_41abaa7f-9b60-4973-a6f8-0cb5d6958d82 58668-5061 HUMAN OTC DRUG CLARINSMEN Antiperspirant ALL DAY DRY ALCOHOL-FREE ALUMINUM CHLOROHYDRATE STICK TOPICAL 20130506 OTC MONOGRAPH FINAL part350 Laboratoires Clarins S.A. ALUMINUM CHLOROHYDRATE 18 g/100g 58668-5351_221b0c0a-37c4-4adb-bffa-30bc5fc0b409 58668-5351 HUMAN OTC DRUG Bronzing Duo SPF 15 Mineral Compact Tint 01 Light TITANIUM DIOXIDE POWDER TOPICAL 20120424 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 8.4 g/100g 58668-5361_d7594dad-6e82-4464-9c68-6ab0fa0d5d2d 58668-5361 HUMAN OTC DRUG Bronzing Duo SPF 15 Mineral Compact Tint 02 Medium TITANIUM DIOXIDE POWDER TOPICAL 20120424 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 8.4 g/100g 58668-5371_acf873c3-38b0-4a5a-bc85-25e8b94d9d25 58668-5371 HUMAN OTC DRUG Bronzing Duo SPF 15 Mineral Compact Tint 03 Dark TITANIUM DIOXIDE POWDER TOPICAL 20120424 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 8.4 g/100g 58668-5810_ee3bdcd2-a03d-4694-9f9b-36809845f373 58668-5810 HUMAN OTC DRUG CLARINS BB Skin Perfecting Broad Spectrum SPF 25 Sunscreen 01 Light TITANIUM DIOXIDE CREAM TOPICAL 20121220 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 47 mg/mL 58668-5820_88bd62f1-7e70-4d05-baec-7098b4398f99 58668-5820 HUMAN OTC DRUG CLARINS BB Skin Perfecting Broad Spectrum SPF 25 Sunscreen 02 Medium TITANIUM DIOXIDE CREAM TOPICAL 20121220 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 47 mg/mL 58668-5830_77a2de8e-abc0-4596-8bf3-89158e8500a2 58668-5830 HUMAN OTC DRUG CLARINS BB Skin Perfecting Broad Spectrum SPF 25 Sunscreen 03 Dark TITANIUM DIOXIDE CREAM TOPICAL 20121220 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 47 mg/mL 58668-5931_d18e99ce-2326-4bed-b6a7-e5a9f471cfbe 58668-5931 HUMAN OTC DRUG CLARINS Age-Control Hand SPF 15 OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE LOTION TOPICAL 20110324 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 58668-5961_92b03907-34f3-4f90-a9fa-f748b26930ae 58668-5961 HUMAN OTC DRUG CLARINS Roll-On Deodorant Anti-perspirant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130311 OTC MONOGRAPH FINAL part350 Laboratoires Clarins S.A. ALUMINUM CHLOROHYDRATE 180 mg/mL 58668-6100_f5c4ea40-0f70-4fdf-9592-9487accb7bf7 58668-6100 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 103 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-6120_c4c85c33-9bfe-40b4-bd66-ea65a36becb0 58668-6120 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 105 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-6130_1e5ac0f0-12de-4423-abfd-2595455be6b3 58668-6130 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 107 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-6140_d73e957d-df0e-4c32-9a57-b481182d9b8e 58668-6140 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 108 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-6150_78fa4912-07aa-4f20-aa04-0e649fa6d666 58668-6150 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 109 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-6160_2e48bd5a-fc45-4f7b-8fef-0bbc4161fff7 58668-6160 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 110 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-6180_30e8401a-e0ac-490d-8d02-3e8be31ca1ac 58668-6180 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 112 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-6190_17a17e81-1a99-4ab7-95a8-cfde48b1a4d9 58668-6190 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 113 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-6200_9a9fe439-6e3a-4c5f-8370-8579ecbf3755 58668-6200 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 114 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-6800_2cc3c25b-b010-4f73-b96a-3f46623a060e 58668-6800 HUMAN OTC DRUG CLARINS BB Skin Perfecting Cream SPF 25 Tint 00 TITANIUM DIOXIDE LIQUID TOPICAL 20140916 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 47 mg/mL 58668-7110_5c95621f-7512-47b4-9ada-0c05d4c72b88 58668-7110 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 Ivory 103 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-7120_94d8acc2-4753-4a1b-9efe-affb736fe553 58668-7120 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 Nude 105 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-7130_75dfec2f-a646-46d9-88df-b75966f608e7 58668-7130 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 beige 107 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-7140_4418682c-cac1-47d9-b9a6-6f2fe1ffac4c 58668-7140 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 sand 108 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-7150_5e06df9e-03f7-4008-9cbf-16d3fc6804af 58668-7150 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 wheat 109 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-7160_6510a08f-e7db-46cf-aa8e-63b17ccc8ec9 58668-7160 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 honey 110 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-7180_6200f801-ea50-4971-9a70-9aff77ed8bab 58668-7180 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 amber 112 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-7190_f6484daa-e1f7-46f0-b160-25153f82de83 58668-7190 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 caramel 112.5 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-7200_4a13b149-a98c-479a-94a8-01b7ddf634ec 58668-7200 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 chestnut 113 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-7210_06d22c22-5339-4c49-aac3-1e9467e9c515 58668-7210 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 capuccino 114 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-7220_b81b8e4a-54ea-4c2a-b3da-194aef9e684e 58668-7220 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 cognac 115 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-7230_740db57d-c661-447f-a319-1836ee445b4e 58668-7230 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 coffee 116.5 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-7240_6c43a9c0-4c7a-4f02-849e-511373218881 58668-7240 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 hazelnut 117 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-7250_8a1dafe9-d6d6-4da7-b845-0b4a36f28738 58668-7250 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 sienna 118 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL 58668-7251_0b6e2074-f93e-4385-b40d-8859f87a4782 58668-7251 HUMAN OTC DRUG Clarins Self Tanning Milk With Sun Protection Spf 6 OCTINOXATE, AVOBENZONE LIQUID TOPICAL 20120829 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; OCTINOXATE 2; 6 mL/100mL; mL/100mL 58686-013_a12a1bd5-c7b7-400f-a8f3-7c7350b61edd 58686-013 HUMAN OTC DRUG Shunfa Anti-Bacteria Spra Didecyldimethyl Ammonium,Triclosan, Borneol, Benzalkonium Bromide SPRAY TOPICAL 20051030 OTC MONOGRAPH NOT FINAL part333A Chengdu Shunfa Disinfection and Washing Technology Co Ltd BENZALKONIUM BROMIDE; BORNEOL; DIDECYLDIMETHYLAMMONIUM; TRICLOSAN 3; 4; 3; 3 mg/1000mg; mg/1000mg; mg/1000mg; mg/1000mg 58690-1001_36986359-867e-49a7-bbdd-9101edd4366b 58690-1001 HUMAN OTC DRUG ZAREE All Kii Coconut Water Allantoin CREAM TOPICAL 20130527 OTC MONOGRAPH FINAL part347 G & NATURE Co., Ltd. ALLANTOIN .02 mg/mL 58697-539_e4dcd54d-6561-47c7-ba02-b1fb494fdbd9 58697-539 HUMAN OTC DRUG Lurosil Menthol GEL TOPICAL 20130617 OTC MONOGRAPH NOT FINAL part348 Pacific Health Collabroative MENTHOL 2.5 g/100g 58701-001_b778ec0c-1aff-459d-802d-7ddb607a8ebf 58701-001 HUMAN OTC DRUG First Class Kit Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130510 OTC MONOGRAPH FINAL part355 American Airlines, Inc. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 58701-002_e2a092a7-f382-4d5a-a8d2-d4e60eec2697 58701-002 HUMAN OTC DRUG Business Class Kit Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130510 OTC MONOGRAPH FINAL part355 American Airlines, Inc. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 58715-001_86000446-985b-4e71-be2f-227ccc227474 58715-001 HUMAN OTC DRUG US Airways RON Kit Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130510 OTC MONOGRAPH FINAL part355 US Airways, Inc SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 58722-9093_439d3b32-c7ba-4d5a-8184-8b4eb1349982 58722-9093 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19840101 UNAPPROVED MEDICAL GAS Triweld Industries, Inc. OXYGEN 99 L/100L 58722-9094_439d3b32-c7ba-4d5a-8184-8b4eb1349982 58722-9094 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19840101 UNAPPROVED MEDICAL GAS Triweld Industries, Inc. OXYGEN 99 L/100L 58733-001_0b068c4d-08aa-44bd-a538-a2f76aff496e 58733-001 HUMAN OTC DRUG United Airlines Business Class Kit Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130510 OTC MONOGRAPH FINAL part355 United Airlines SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 58737-101_d7ca7f81-ad96-4e71-b4c0-caf1fcedbd5e 58737-101 HUMAN OTC DRUG Berry Scented Hand Sanitizer Cars Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE .06 mg/59mg 58737-102_f5874e47-d1fd-4f0f-875b-2497c879b05e 58737-102 HUMAN OTC DRUG Berry Scented Hand Sanitizer Mickey Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE .06 mg/59mg 58737-103_d824de9d-5ea5-4270-9f25-550b50ce51bc 58737-103 HUMAN OTC DRUG Berry Scented Hand Sanitizer Princesses Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE .06 mg/59mg 58737-104_2fe90756-a800-42e0-9cb9-15ce7f2914d7 58737-104 HUMAN OTC DRUG Berry Scented Hand Sanitizer Minnie Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE .06 mg/59mg 58737-105_6fa3f425-91fe-46bc-b9d3-b453ad680ec9 58737-105 HUMAN OTC DRUG Berry Scented Hand Sanitizer Girl Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE .06 mg/59mg 58737-106_657fc68d-e0bf-48e0-9e76-5f07e53412f8 58737-106 HUMAN OTC DRUG Berry Scented Hand Sanitizer Avengers Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE .06 mg/59mg 58737-107_9f65ef27-923a-40e6-9c8b-7b7654f7fe52 58737-107 HUMAN OTC DRUG Berry Scented Hand Sanitizer Spiderman Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE .06 mg/59mg 58737-108_f7effd5a-1df2-4c0b-b411-7812e54d3521 58737-108 HUMAN OTC DRUG Fruit Punch Scented Hand Sanitizer Frozen Benzalkonium Chloride GEL TOPICAL 20140603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g 58737-109_e5764453-8c95-487e-b3fc-d2380f88bf1d 58737-109 HUMAN OTC DRUG Berry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g 58737-110_28eb5417-4f2d-4a20-9c91-ea32b82fc114 58737-110 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g 58737-111_9155cc8d-2d09-43c5-9ef7-a4fa44587ac7 58737-111 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g 58737-112_c1bd94bb-cf19-47d4-b803-6641797ea9b5 58737-112 HUMAN OTC DRUG Raspberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g 58737-113_cb1ff1c8-4601-40ad-9065-0dcf2e9c4617 58737-113 HUMAN OTC DRUG Mixed Berries Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g 58748-001_8e1662ad-37ac-4216-b2f7-d85d8aebe0e6 58748-001 HUMAN OTC DRUG Cotta Sodium Hyaluronate, Snail Secretion Filtrate, Morus Alba Bark Extract FILM, EXTENDED RELEASE TOPICAL 20130701 UNAPPROVED DRUG OTHER ECO INDUSTRY CO., LTD GARDEN SNAIL MUCIN; HYALURONATE SODIUM; MORUS ALBA ROOT BARK .1; .3; .1 g/100g; g/100g; g/100g 58755-0001_2b4c4f4f-0a87-4af2-a8ac-5c9effc93982 58755-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19950915 UNAPPROVED MEDICAL GAS Browning's Pharmacy and Healthcare Inc. OXYGEN 99 L/100L 58767-722_26e0479b-a751-4e26-b338-c63b01006d26 58767-722 HUMAN OTC DRUG CEDERROTH Emergency Eye Wash WATER LIQUID OPHTHALMIC 20140313 OTC MONOGRAPH FINAL part349 Cederroth AB WATER 99 mL/100mL 58767-725_a5e66c5f-3d0e-4fc2-a6c8-dc42d929164c 58767-725 HUMAN OTC DRUG CEDERROTH Emergency Eye Wash Water LIQUID OPHTHALMIC 20130823 OTC MONOGRAPH FINAL part349 Cederroth AB WATER .99 mL/mL 58789-001_62291510-9dec-4804-ae5b-c94f4cb227f5 58789-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Airgas Northern California and Nevada, Inc. OXYGEN 992 mL/L 58789-002_11bc9e36-54fc-49ed-9474-2cbc639c5628 58789-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Airgas Northern California and Nevada, Inc. NITROGEN 992 mL/L 58789-003_8ff0d4f1-9da8-47ae-8325-d76240146ceb 58789-003 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Airgas Northern California and Nevada, Inc. CARBON DIOXIDE 992 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 58789-005_6869fd3c-cdaa-4626-a9cd-f8427c76011a 58789-005 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Airgas Northern California and Nevada, Inc. HELIUM 999 mL/L 58789-006_ff7d204f-2c35-42b1-a264-4209c27fdcf5 58789-006 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Airgas Northern California and Nevada, Inc. NITROUS OXIDE 992 mL/L 58789-500_9b8e952f-7f55-43c7-944d-581de60cd875 58789-500 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Airgas Northern California and Nevada, Inc. AIR 1000 mL/L 58790-000_7dddff3c-a1cb-4019-887c-6f484c139725 58790-000 HUMAN OTC DRUG TheraTears Lubricant carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 19950101 OTC MONOGRAPH FINAL part349 Advanced Vision Research (Subsidiary of Akorn, Inc.) CARBOXYMETHYLCELLULOSE SODIUM 2.5 mg/mL 58790-001_60c44637-dd61-4d93-a4d9-1fd0d373c00d 58790-001 HUMAN OTC DRUG TheraTears Lubricant carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 19990701 OTC MONOGRAPH FINAL part349 Advanced Vision Research (Subsidiary of Akorn, Inc.) CARBOXYMETHYLCELLULOSE SODIUM 2.5 mg/mL 58790-002_71cf00b4-5437-454a-a827-253383798df9 58790-002 HUMAN OTC DRUG TheraTears carboxymethylcellulose sodium GEL OPHTHALMIC 20021201 OTC MONOGRAPH FINAL part349 Advanced Vision Research (Subsidiary of Akorn, Inc.) CARBOXYMETHYLCELLULOSE SODIUM 10 mg/mL 58790-008_1690a8bc-16a9-49d3-a554-ce976662e36e 58790-008 HUMAN OTC DRUG Ketotifen Fumarate Ketotifen Fumarate SOLUTION OPHTHALMIC 20120315 ANDA ANDA077958 Advanced Vision Research (Subsidiary of Akorn, Inc.) KETOTIFEN FUMARATE .35 mg/mL 58790-301_f5b013f8-7d26-4eb8-bbe8-4b5fd77c8c60 58790-301 HUMAN OTC DRUG Allergy Eye Drops Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20131114 ANDA ANDA077958 Advanced Vision Research (Subsidiary of Akorn, Inc.) KETOTIFEN FUMARATE .35 mg/mL 58805-001_108b7ac2-082d-47d4-a07d-58c50e40bb5c 58805-001 HUMAN OTC DRUG Diphenhydramine Hcl Diphenhydramine Hcl CAPSULE, LIQUID FILLED ORAL 20131015 OTC MONOGRAPH FINAL part341 Agile Pharmachem DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 58805-002_9a0a8cfd-d40c-45f7-b7c8-4a4799128d9b 58805-002 HUMAN OTC DRUG Acetaminophen,Dextromethorphan,Phenylephrine Acetaminophen,Dextromethorphan,Phenylephrine CAPSULE, LIQUID FILLED ORAL 20140501 OTC MONOGRAPH FINAL part341 Agile Pharmachem ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 58805-003_e528f188-a1c7-4c55-803d-6dd5cae912ca 58805-003 HUMAN OTC DRUG Acetaminophen,Dextromethorphan,Doxylamine Acetaminophen,Dextromethorphan,Doxylamine CAPSULE, LIQUID FILLED ORAL 20140501 OTC MONOGRAPH FINAL part341 Agile Pharmachem ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 10; 6.25 mg/1; mg/1; mg/1 58805-004_27b23ef9-8cde-407d-a363-0fbb3ae5a196 58805-004 HUMAN OTC DRUG DAYTIME NIGHTTIME COLD/FLU acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl KIT ORAL 20140801 OTC MONOGRAPH FINAL part341 Agile Pharmachem 58805-006_113c91a5-8ebc-4fbc-967e-1f8ed8a63be4 58805-006 HUMAN OTC DRUG Nightime Sleep Aid Diphenhydramine CAPSULE, LIQUID FILLED ORAL 20140331 OTC MONOGRAPH FINAL part341 Agile Pharmachem DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 58809-287_d4b33779-3772-4c90-b144-0d81376b5eeb 58809-287 HUMAN PRESCRIPTION DRUG Active OB ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, ZINC OXIDE, CUPRIC SULFATE, and DOCONEXENT CAPSULE, LIQUID FILLED ORAL 20131028 UNAPPROVED DRUG OTHER GM Pharmaceuticals, Inc. .ALPHA.-TOCOPHEROL ACETATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; DOCONEXENT; FOLIC ACID; IRON PENTACARBONYL; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 30; 100; 400; 2; 30; 320; 1; 20; 20; 4; 2; 30 [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 58809-333_0f905d99-1b69-42f8-9cb9-b47f6309e253 58809-333 HUMAN PRESCRIPTION DRUG MyOxin Chloroxylenol, Benzocaine, and Hydrocortisone Acetate SOLUTION TOPICAL 20110801 UNAPPROVED DRUG OTHER GM Pharamceuticals, Inc BENZOCAINE; CHLOROXYLENOL; HYDROCORTISONE ACETATE 15; 1; 10 mg/mL; mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 58809-350_828f30bb-6409-4610-b6c6-9c60eb0426c4 58809-350 HUMAN OTC DRUG VANACOF-8 CHLOPHEDIANOL HYDROCHLORIDE and PYRILAMINE MALEATE LIQUID ORAL 20130601 OTC MONOGRAPH FINAL part341 GM PHARMACEUTICALS,INC CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE 25; 50 mg/15mL; mg/15mL 58809-407_a4fbc4cf-d6cb-4fdf-97a8-be23c47a4a13 58809-407 HUMAN OTC DRUG VANATAB DX Chlophedianol Hydrochloride, Guaifenesin, Pseudoephedrine Hydrochloride TABLET ORAL 20110906 20150228 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, Inc. CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 12.5; 200; 30 mg/1; mg/1; mg/1 58809-501_2177b4bb-9c6f-45a8-8cd1-c9ca296bafec 58809-501 HUMAN OTC DRUG VANAHIST PD TRIPROLIDINE HYDROCHLORIDE LIQUID ORAL 20140319 OTC MONOGRAPH FINAL part341 GM PHARMACEUTICALS,INC TRIPROLIDINE HYDROCHLORIDE .625 mg/mL 58809-536_c28eb54a-8b11-4174-afc3-3330dace34a3 58809-536 HUMAN PRESCRIPTION DRUG CARBATUSS Carbetapentane Citrate, Phenylephrine Hydrochloride, Guaifenesin LIQUID ORAL 20001101 UNAPPROVED DRUG OTHER GM Pharmaceuticals, Inc. CARBETAPENTANE CITRATE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 100; 10 mg/5mL; mg/5mL; mg/5mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 58809-555_713587d8-6753-46ba-864e-ae8e362d64b7 58809-555 HUMAN OTC DRUG VANACOF DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20130601 OTC MONOGRAPH FINAL part341 GM PHARMACEUTICALS,INC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 18; 200; 10 mg/15mL; mg/15mL; mg/15mL 58809-578_d6f296c8-49bd-44dc-9d63-bf720372e69e 58809-578 HUMAN OTC DRUG NASOPEN Chlorcyclizine Hydrochloride, Pseudoephedrine Hydrochloride LIQUID ORAL 20110606 20150228 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, Inc. CHLORCYCLIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 9.375; 30 mg/5mL; mg/5mL 58809-725_8fd68a8d-c88f-4f08-b24c-9eac6e622851 58809-725 HUMAN PRESCRIPTION DRUG Active FE .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, MAGNESIUM OXIDE, ZINC OXIDE, and CUPRIC OXIDE TABLET ORAL 20131111 UNAPPROVED DRUG OTHER GM Pharmaceuticals, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FOLIC ACID; IRON PENTACARBONYL; MAGNESIUM OXIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; ZINC OXIDE 40; 2100; 160; 400; 1; 30; 1250; 75; 30; 20; 20; 4; 4; 20 [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 58809-729_44c2c20b-fdd4-41b4-b4f1-50131bb056b2 58809-729 HUMAN OTC DRUG NASOPEN PE Phenylephrine Hydrochloride, Thonzylamine Hydrochloride LIQUID ORAL 20121003 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, Inc PHENYLEPHRINE HYDROCHLORIDE; THONZYLAMINE HYDROCHLORIDE 10; 50 mg/15mL; mg/15mL 58809-829_294e41a8-6432-4edf-abf4-35b2a96eec1e 58809-829 HUMAN PRESCRIPTION DRUG Escavite D .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, HYDROXOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, FERROUS CYSTEINE GLYCINATE, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, and SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20140303 UNAPPROVED DRUG OTHER GM Pharmaceuticals, Inc. .ALPHA.-TOCOPHEROL, DL-; .BETA.-CAROTENE; ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CUPRIC OXIDE; FERROUS CYSTEINE GLYCINATE; FOLIC ACID; HYDROXOCOBALAMIN; MAGNESIUM OXIDE; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; ZINC OXIDE 30; 2500; 100; 45; 10; 600; 2; 6; 400; 6; 60; 20; 2; 1.7; .25; 1.5; 15 [iU]/1; [iU]/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Antidote [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 58809-877_885e0044-cd36-4b6d-8dc1-e910a12a472f 58809-877 HUMAN PRESCRIPTION DRUG ESCAVITE LQ VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, FERRIC PYROPHOSPHATE, FERROUS CYSTEINE GLYCINATE, and SODIUM FLUORIDE LIQUID ORAL 20130820 UNAPPROVED DRUG OTHER GM PHARMACEUTICALS,INC .ALPHA.-TOCOPHEROL ACETATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FERRIC PYROPHOSPHATE; FERROUS CYSTEINE GLYCINATE; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE 7.5; 35; 400; .9; 5; 1; 8; .4; .6; .25; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 58809-888_935bc301-7376-4676-8ba5-085e4463e5a2 58809-888 HUMAN PRESCRIPTION DRUG Escavite Sodium Fluoride, Vitamin A Acetate, Biotin, Magnesium, Zinc, Copper, Calcium Pantothenate, Folic Acid, Iron, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, and CYANOCOBALAMIN TABLET, CHEWABLE ORAL 20120201 UNAPPROVED DRUG OTHER GM Pharmaceuticals, Inc. .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC 30; 100; 45; 10; 400; 1; 9; .4; 7.5; 60; 20; 2; 1.7; .25; 1.5; 1000; 7.4 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 58809-907_6a9d3ac3-60b6-4c9f-981f-0209ff524811 58809-907 HUMAN OTC DRUG VANACOF DX Chlophedianol Hydrochloride, Guaifenesin, and Pseudoephedrine Hydrochloride LIQUID ORAL 20080423 20150430 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 12.5; 100; 30 mg/5mL; mg/5mL; mg/5mL 58809-999_351175ac-226e-46ee-b10d-9be1062ed97d 58809-999 HUMAN OTC DRUG VANACOF Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, and Pseudoephedrine Hydrochloride LIQUID ORAL 20080422 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 12.5; 1; 30 mg/5mL; mg/5mL; mg/5mL 58831-1001_af3ce657-d6c9-4961-89f2-7eb15ecc63fa 58831-1001 HUMAN OTC DRUG EGF UV SHIELD OCTINOXATE CREAM TOPICAL 20130626 OTC MONOGRAPH NOT FINAL part352 Dermaesthetics Inc. AMILOXATE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2; 7.5; 5; 4.15; 4.9 g/60g; g/60g; g/60g; g/60g; g/60g 58836-0972_be0ac0e2-7d33-4ac8-a5f3-0b9e1496de3a 58836-0972 HUMAN OTC DRUG Total Bromine Bromine LIQUID ORAL 20110729 UNAPPROVED HOMEOPATHIC White Manufacturing Incorporated BROMINE 15 [hp_X]/30mL 58836-0973_5efbc82f-40c7-41f8-8ebf-4d69269d2231 58836-0973 HUMAN OTC DRUG Total Chlorine Chlorinum LIQUID ORAL 20110815 UNAPPROVED HOMEOPATHIC White Manufacturing Incorporated CHLORINE 15 [hp_X]/30mL 58852-000_22bb1787-a114-42f3-8689-b44c8922ea0d 58852-000 HUMAN OTC DRUG Mens ComBack HAIR REGROWTH TREATMENT EXTRA STRENGTH UNSCENTED MINOXIDIL LIQUID TOPICAL 20130606 ANDA ANDA076239 Combback International LLC MINOXIDIL 50 mg/mL 58875-101_e0dd7b3f-fd21-4e0d-94a2-8603b38c9442 58875-101 HUMAN OTC DRUG Hard Candy Correction Creme Octinoxate, Octisalate CREAM TOPICAL 20130612 OTC MONOGRAPH NOT FINAL part352 Xtreme Color Inc. OCTINOXATE; OCTISALATE 2.55; 1.7 g/42.5g; g/42.5g 58876-101_25a6216f-6a84-49d8-bd6b-bb2601bd99b0 58876-101 HUMAN OTC DRUG DAILY CLEANSER SALICYLIC ACID ACNE TREATMENT SALICYLIC ACID GEL TOPICAL 20130613 OTC MONOGRAPH FINAL part333D DR LIN SKINCARE SALICYLIC ACID 2 g/100mL 58876-102_a19b116f-e0fa-400a-a708-ac0315856c05 58876-102 HUMAN OTC DRUG ACNE CLEANSING PADS SALICYLIC ACID LIQUID TOPICAL 20130613 OTC MONOGRAPH FINAL part333D DR LIN SKINCARE SALICYLIC ACID .02 g/1 58876-103_5f97983e-e7be-472e-a44b-05796179e59a 58876-103 HUMAN OTC DRUG ACNE SPOT CORRECTOR BENZOYL PEROXIDE CREAM TOPICAL 20130613 OTC MONOGRAPH FINAL part333D DR LIN SKINCARE BENZOYL PEROXIDE 5 g/100mL 58876-104_7cc5962a-40f8-419e-89fa-6503ce5fc044 58876-104 HUMAN OTC DRUG DR. LIN SKINCARE ACNE BENZOYL PEROXIDE LOTION TOPICAL 20130626 OTC MONOGRAPH FINAL part333D DR LIN SKINCARE BENZOYL PEROXIDE 2.5 g/100mL 58876-105_265c782f-bc67-48a4-a2f6-922bcd826913 58876-105 HUMAN OTC DRUG ACNE CLEANSING WIPES SALICYLIC ACID LIQUID TOPICAL 20130613 OTC MONOGRAPH FINAL part333D DR LIN SKINCARE SALICYLIC ACID .02 g/1 58876-106_7dc59181-8f6a-40af-b5f6-5e5bada5d508 58876-106 HUMAN OTC DRUG ACNE SPOT CORRECTOR MAXIMUM STRENGTH BENZOYL PEROXIDE CREAM TOPICAL 20130613 OTC MONOGRAPH FINAL part333D DR LIN SKINCARE BENZOYL PEROXIDE 10 g/100mL 58876-107_8c7e10d0-e160-430e-8ef8-4ef95b7e1c13 58876-107 HUMAN OTC DRUG INTENSIVE FACE AND BODY ACNE TREATMENT BENZOYL PEROXIDE GEL TOPICAL 20140711 OTC MONOGRAPH FINAL part333D DR LIN SKINCARE BENZOYL PEROXIDE 10 g/100mL 58876-108_03bc5e2e-4880-4f53-9493-3fddd0566666 58876-108 HUMAN OTC DRUG MEDICATED ACNE SHOWER SALICYLIC ACID GEL TOPICAL 20130613 OTC MONOGRAPH FINAL part333D DR LIN SKINCARE SALICYLIC ACID 2 g/100mL 58878-0001_4e463c16-09ed-44f0-b9e2-0d7f7d85e8f2 58878-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19901212 UNAPPROVED MEDICAL GAS Shasta Welding Supply, Inc. OXYGEN 99 L/100L 58892-070_ef82223e-f4df-4917-baae-d305ad052fb6 58892-070 HUMAN OTC DRUG Cotz Plus SPF 58 Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 100; 30 mg/g; mg/g 58892-118_c8522483-b25f-4948-8976-a6a67d396454 58892-118 HUMAN OTC DRUG CoTZ SPF 35 Sunscreen Zinc Oxide LOTION TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. ZINC OXIDE 200 mg/g 58892-125_5d4a9076-4a63-4ea3-8776-802e06fba806 58892-125 HUMAN OTC DRUG LipCoTZ Lip Balm/Sunscreen Titanium Dioxide, Zinc Oxide LIPSTICK TOPICAL 20050401 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 40; 55 mg/g; mg/g 58892-126_e51f9ed7-389f-4b5b-b9b3-5a408350a7bb 58892-126 HUMAN OTC DRUG Cotz Lip Balm Lip Balm/Sunscreen Titanium Dioxide, Zinc Oxide LIPSTICK TOPICAL 20040102 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 40; 55 mg/g; mg/g 58892-130_32eebeb8-ed24-42ce-b239-d2d75b30f79a 58892-130 HUMAN OTC DRUG Solar Protection Formula TiZO SheerFoam Sunscreen Titanium Dioxide, Zinc Oxide AEROSOL, FOAM TOPICAL 20120420 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 30; 100 mg/g; mg/g 58892-218_7dd87237-d76f-45d1-a56d-d340efe81719 58892-218 HUMAN OTC DRUG Solar Protection Formula TiZO Body Sunscreen Zinc Oxide CREAM TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. ZINC OXIDE 200 mg/g 58892-240_dbea6f0c-95d1-420f-85ff-b97845ca3018 58892-240 HUMAN OTC DRUG Solar Protection Formula LipTect Lip Balm/Sunscreen Titanium Dioxide, Zinc Oxide LIPSTICK TOPICAL 20040102 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 40; 55 mg/g; mg/g 58892-265_0c5df784-589a-48e8-a719-f8e79609215b 58892-265 HUMAN OTC DRUG Solar Protection Formula SPF 65 Sunscreen Octinoxate, Octocrylene, Oxybenzone, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20040102 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 60; 70; 40; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58892-318_3279ee92-0ab5-498e-8483-3e7ee6a00824 58892-318 HUMAN OTC DRUG Solar Protection Formula TiZO SPF 35 Sunscreen Zinc Oxide LOTION TOPICAL 20120902 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. ZINC OXIDE 200 mg/g 58892-326_2a630d89-3a34-4a56-a494-ba02b7a833ca 58892-326 HUMAN OTC DRUG Solar Protection Formula TiZO3 Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20070521 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 85.4; 40.7 mg/mL; mg/mL 58892-336_5d91737b-e62c-4647-9c70-2acccd9ec497 58892-336 HUMAN OTC DRUG Solar Protection Formula TiZO2 Light Skin Formula Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20090301 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 85.4; 40.7 mg/mL; mg/mL 58892-346_769c18c0-c9d3-4866-99e8-eb2b8680f58b 58892-346 HUMAN OTC DRUG FaceCoTZ (Sunscreen) Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20090301 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 85.4; 40.7 mg/mL; mg/mL 58892-347_31de0954-6db4-427d-8404-3095c0e7c057 58892-347 HUMAN OTC DRUG Cotz Face (For Lighter Skin Tones) SPF 40 Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120719 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 80; 38 mg/g; mg/g 58892-356_307df76d-c5b5-4c22-9507-05fcc5bf6d15 58892-356 HUMAN OTC DRUG Cotz Face (Natural Skin Tone) SPF 40 Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120214 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 80; 38 mg/g; mg/g 58892-418_7956ec06-a9ce-46d4-a721-e5c21ee1d18c 58892-418 HUMAN OTC DRUG Cotz Sensitive SPF 40 Sunscreen Zinc Oxide LOTION TOPICAL 20120330 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. ZINC OXIDE 200 mg/g 58892-518_6d2bf152-c7e9-4e52-9615-dfe0120cab79 58892-518 HUMAN OTC DRUG Cotz Pediatric SPF 40 Sunscreen Zinc Oxide LOTION TOPICAL 20120907 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. ZINC OXIDE 200 mg/g 58892-600_4d32c38b-7b9d-4c85-b279-af8d55c3b9b3 58892-600 HUMAN OTC DRUG Cotz Pure SPF 30 Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120214 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 41; 84 mg/g; mg/g 58892-721_eb1a06d9-31fc-4d5c-b8d7-cafd6a9cf6b7 58892-721 HUMAN OTC DRUG Solar Protection Formula SPF 60 Tinted Concealer - (Beige) Sunscreen Octinoxate, Octocrylene, Oxybenzone, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 19940601 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 69; 81; 46; 115; 39 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58892-722_eb1a06d9-31fc-4d5c-b8d7-cafd6a9cf6b7 58892-722 HUMAN OTC DRUG Solar Protection Formula SPF 60 Tinted Concealer - (Honey) Sunscreen Octinoxate, Octocrylene, Oxybenzone, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 19940601 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 69; 81; 46; 115; 39 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58892-723_eb1a06d9-31fc-4d5c-b8d7-cafd6a9cf6b7 58892-723 HUMAN OTC DRUG Solar Protection Formula SPF 60 Tinted Concealer - (Blush) Sunscreen Octinoxate, Octocrylene, Oxybenzone, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 19940601 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 69; 81; 46; 115; 39 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 58892-910_62bf906c-ca32-4c8f-be85-a6832d1351ff 58892-910 HUMAN OTC DRUG CoTZ SPF 58 Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20040102 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 100; 30 mg/g; mg/g 58892-911_e5ac22f4-f5ae-4fde-9e79-eea783d371b9 58892-911 HUMAN OTC DRUG Solar Protection Formula SPF 58 Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20040102 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 100; 30 mg/g; mg/g 58895-1001_896c4911-af27-4a5e-8015-17c5c83cfdc1 58895-1001 HUMAN OTC DRUG MODLINA PEPTIDE SOOTHING ESSENTIAL HYDROGEL MASK PACK GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 Modlina Cosmetics Co., Ltd GLYCERIN .01 g/g 58895-2001_f7ca6424-a2b7-42d4-851b-a104b0b2c2db 58895-2001 HUMAN OTC DRUG BEAUTIFUL WOMANS HAIR LOVES COLORFUL BUBBLES HAIR DYE 5N NATURAL BROWN P-AMINOPHENOL LIQUID TOPICAL 20130812 UNAPPROVED DRUG OTHER Modlina Cosmetics Co., Ltd P-AMINOPHENOL .01 mg/mL 58895-3001_3b992f86-b32d-421f-b836-5d30a9174299 58895-3001 HUMAN OTC DRUG BEAUTIFUL WOMANS HAIR LOVES COLORFUL BUBBLES HAIR DYE 3N DARK BROWN P-PHENYLENEDIAMINE LIQUID TOPICAL 20130812 UNAPPROVED DRUG OTHER Modlina Cosmetics Co., Ltd P-PHENYLENEDIAMINE .01 mg/mL 58906-1001_e5d14db1-45cf-4ee1-8ffe-c9530ae221b5 58906-1001 HUMAN OTC DRUG BURZANGMURY GOLD GLYCERIN SHAMPOO TOPICAL 20130801 OTC MONOGRAPH FINAL part347 Dae Deok bio Inc GLYCERIN .01 g/mL 58906-2001_6a6181f1-82fc-47c4-b17e-6825f693f7a8 58906-2001 HUMAN OTC DRUG BURZANGMURY GOLD TREATMENT GLYCERIN LIQUID TOPICAL 20130816 OTC MONOGRAPH FINAL part347 Dae Deok bio Inc GLYCERIN .01 g/mL 58912-1001_b5fb11da-e49e-4b90-b7d1-ffd1a4e626f7 58912-1001 HUMAN OTC DRUG Mirapharm-22 PANAX GINSENG WHOLE CAPSULE ORAL 20130725 UNAPPROVED DRUG OTHER Uni Bio-Tech Inc PANAX GINSENG WHOLE .06 mg/.3mg 58912-2001_9994cd61-f81f-48f4-a699-69a033d85a32 58912-2001 HUMAN OTC DRUG Mirapharm-22 PANAX GINSENG WHOLE CAPSULE ORAL 20131116 UNAPPROVED DRUG OTHER Uni Bio-Tech Inc PANAX GINSENG WHOLE .3 g/1 58914-003_e10091e4-71b9-47bd-a6e1-1b53de27430f 58914-003 HUMAN PRESCRIPTION DRUG ULTRESA Pancrelipase CAPSULE, DELAYED RELEASE ORAL 20120301 NDA NDA022222 Aptalis Pharma US, Inc PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 27600; 13800; 27600 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 58914-005_e10091e4-71b9-47bd-a6e1-1b53de27430f 58914-005 HUMAN PRESCRIPTION DRUG ULTRESA Pancrelipase CAPSULE, DELAYED RELEASE ORAL 20120301 NDA NDA022222 Aptalis Pharma US, Inc PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 46000; 23000; 46000 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 58914-012_1429a692-c49b-456c-9202-9a666041c916 58914-012 HUMAN PRESCRIPTION DRUG Bentyl Dicyclomine hydrochloride CAPSULE ORAL 19500511 NDA NDA007409 Aptalis Pharma US, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 58914-013_1429a692-c49b-456c-9202-9a666041c916 58914-013 HUMAN PRESCRIPTION DRUG Bentyl Dicyclomine hydrochloride TABLET ORAL 19500511 NDA NDA007409 Aptalis Pharma US, Inc. DICYCLOMINE HYDROCHLORIDE 20.6 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 58914-019_e10091e4-71b9-47bd-a6e1-1b53de27430f 58914-019 HUMAN PRESCRIPTION DRUG ULTRESA Pancrelipase CAPSULE, DELAYED RELEASE ORAL 20120301 NDA NDA022222 Aptalis Pharma US, Inc PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 41400; 20700; 41400 [USP&apos'U]/1; [USP&apos'U]/1; [USP&apos'U]/1 58914-080_1429a692-c49b-456c-9202-9a666041c916 58914-080 HUMAN PRESCRIPTION DRUG Bentyl Dicyclomine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 19520813 NDA NDA008370 Aptalis Pharma US, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/2mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 58914-112_120dc05b-dfe5-464d-95e0-7c006078f856 58914-112 HUMAN PRESCRIPTION DRUG Viokace Pancrelipase TABLET ORAL 20120301 NDA NDA022542 Aptalis Pharma US, Inc PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 39150; 10440; 39150 [USP'U]/1; [USP'U]/1; [USP'U]/1 58914-117_120dc05b-dfe5-464d-95e0-7c006078f856 58914-117 HUMAN PRESCRIPTION DRUG Viokace Pancrelipase TABLET ORAL 20120301 NDA NDA022542 Aptalis Pharma US, Inc PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 78300; 20880; 78300 [USP'U]/1; [USP'U]/1; [USP'U]/1 58914-170_f47cc79f-d18e-4395-8189-7645bf572741 58914-170 HUMAN PRESCRIPTION DRUG Carafate Sucralfate SUSPENSION ORAL 19931216 NDA NDA019183 Aptalis Pharma Inc. SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 58914-171_96119ecc-c980-45b0-9272-1646042d2a5a 58914-171 HUMAN PRESCRIPTION DRUG Carafate Sucralfate TABLET ORAL 19811030 NDA NDA018333 Aptalis Pharma US, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 58914-301_713d6599-9d1c-46ad-9216-bad512105877 58914-301 HUMAN PRESCRIPTION DRUG Rectiv nitroglycerin OINTMENT RECTAL 20110621 NDA NDA021359 Aptalis Pharma US, Inc. NITROGLYCERIN 4 mg/g Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 58914-501_4fd91f27-1189-4193-828e-2336cc60a729 58914-501 HUMAN PRESCRIPTION DRUG CANASA Mesalamine SUPPOSITORY RECTAL 20010105 NDA NDA021252 Aptalis Pharma US, Inc. MESALAMINE 1000 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 58914-600_937f6e5f-5c9d-4f4f-9a35-caaeb5e3b9c1 58914-600 HUMAN PRESCRIPTION DRUG Pylera Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride CAPSULE ORAL 20070501 20150228 NDA NDA050786 Aptalis Pharma US, Inc. BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE 140; 125; 125 mg/1; mg/1; mg/1 Bismuth [Chemical/Ingredient],Bismuth [EPC],Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient],Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 58914-601_937f6e5f-5c9d-4f4f-9a35-caaeb5e3b9c1 58914-601 HUMAN PRESCRIPTION DRUG Pylera Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride CAPSULE ORAL 20130801 NDA NDA050786 Aptalis Pharma US, Inc. BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE 140; 125; 125 mg/1; mg/1; mg/1 Bismuth [Chemical/Ingredient],Bismuth [EPC],Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient],Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 58914-785_6f988c2c-e19d-41a7-9d13-80252a28873e 58914-785 HUMAN PRESCRIPTION DRUG Urso 250 Ursodiol TABLET, FILM COATED ORAL 19971210 NDA NDA020675 Aptalis Pharma US, Inc. URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 58914-790_6f988c2c-e19d-41a7-9d13-80252a28873e 58914-790 HUMAN PRESCRIPTION DRUG Urso Forte Ursodiol TABLET, FILM COATED ORAL 19971210 NDA NDA020675 Aptalis Pharma US, Inc. URSODIOL 500 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 58929-100_6d0ebb89-86ff-4f7f-97f7-0f8a63c63b6f 58929-100 HUMAN OTC DRUG Genuine Efficascent CAMPHOR, MENTHOL, METHYL SALICYLATE OIL TOPICAL 20100524 OTC MONOGRAPH FINAL part348 International Pharmaceuticals Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 1.45; 18.35 mL/100mL; mL/100mL; mL/100mL 58929-200_610b5adf-ffe2-4015-9467-827ade97f056 58929-200 HUMAN OTC DRUG Omega Pain Relieving CAMPHOR, MENTHOL, METHYL SALICYLATE LINIMENT TOPICAL 20100524 OTC MONOGRAPH FINAL part348 International Pharmaceuticals, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 3.33; 14.775 mL/100mL; 1/100mL; mL/100mL 58929-300_95c31a13-0e33-49fe-85f7-2ec9a04a0346 58929-300 HUMAN OTC DRUG DR. S. WONGS ACNE TREATMENT SULPHUR SULFUR SOAP TOPICAL 20100524 OTC MONOGRAPH FINAL part333 International Pharmaceuticals, Inc. SULFUR 3 g/100g 58930-001_ac62cd6e-a3d8-49fc-9d67-3461f439be0f 58930-001 HUMAN OTC DRUG A.H.C Real Eye For Face Adenosine CREAM TOPICAL 20130621 UNAPPROVED DRUG OTHER Carver Korea Co Ltd ADENOSINE .12 mg/30mL 58930-011_ccb26223-f304-45d0-948a-5300aacbade9 58930-011 HUMAN OTC DRUG A.H.C. C-SERUM Niacinamide CREAM TOPICAL 20130705 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd NIACINAMIDE .6 g/30mL 58930-012_90baa840-63f9-4bc5-a782-9355eb7b9996 58930-012 HUMAN OTC DRUG A.H.C. C-CREAM Niacinamide CREAM TOPICAL 20130705 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd NIACINAMIDE 1 g/50mL 58930-013_97b01aca-8bfd-4f24-96ff-6b61ea6f7308 58930-013 HUMAN OTC DRUG A.H.C. C-TONER Niacinamide LIQUID TOPICAL 20130705 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd NIACINAMIDE 2.4 g/120mL 58930-014_c5bd013a-ec1c-4f15-ad48-59a6e6c75224 58930-014 HUMAN OTC DRUG A.H.C. COMPLETE CHOICE liftox Cream TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd TITANIUM DIOXIDE; ZINC OXIDE 1.435; 686 g/35mL; mg/35mL 58930-015_9be09393-b2ea-4c61-b45a-9e90586c00e5 58930-015 HUMAN OTC DRUG A.H.C. COMPLETE CHOICE Moisture Cream ETHYLHEXYL METHOXYCINNAMATE, TITANUIM DIOXIDE, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHAN CREAM TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd AVOBENZONE; OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE .42; 2.62; .7; 1.085 g/35mL; g/35mL; g/35mL; g/35mL 58930-016_f75af596-5915-4e4e-90a2-c326b2333a9f 58930-016 HUMAN OTC DRUG A.H.C. COMPLETE CHOICE Color Change Cream ETHYLHEXYL METHOXYCINNAMATE, TITANUIM DIOXIDE, ETHYLHEXYL SALICYTLATE, ZINC OXIDE CREAM TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.62; 1.75; 2.14; 1.715 g/35mL; g/35mL; g/35mL; g/35mL 58930-017_ecba909e-62e9-47d5-b40d-be75e6e3f5ca 58930-017 HUMAN OTC DRUG COMPLETE CHOICE Moisture Amploule Adenosine LIQUID TOPICAL 20130705 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE 6 mg/15mL 58930-018_087d7941-9175-484e-add4-d29bbcaca757 58930-018 HUMAN OTC DRUG Supreme Shield Octinoxate, Octocrylene, Zinc Oxide AEROSOL, SPRAY TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 1.68; 1.2; .576 g/80mL; g/80mL; g/80mL 58930-019_7b4e6150-1dc8-4b71-9fd8-c00cf7dd02d8 58930-019 HUMAN OTC DRUG Supreme Shield Octinoxate, Octocrylene, Zinc Oxide AEROSOL, SPRAY TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 1.68; 1.2; .576 g/80mL; g/80mL; g/80mL 58930-020_a0546a7f-8e75-4ada-a290-9c0b6d058a20 58930-020 HUMAN OTC DRUG Supreme Shield Octinoxate, Octocrylene, Zinc Oxide AEROSOL, SPRAY TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 1.68; 1.2; .576 g/80mL; g/80mL; g/80mL 58930-021_7e19c0a8-cafe-4619-88e6-dead8324cf16 58930-021 HUMAN OTC DRUG AHC Intense Contour Balm Titanium Dioxide CREAM TOPICAL 20130730 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd. TITANIUM DIOXIDE 2.46 g/30mL 58930-022_4003ab97-852f-4e0a-a790-31926a06eda1 58930-022 HUMAN OTC DRUG AHC Intense Contour Balm Light Titanium Dioxide CREAM TOPICAL 20130730 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd. TITANIUM DIOXIDE 2.46 g/30mL 58930-023_0529200a-5eac-42c0-906c-fa40da49a88e 58930-023 HUMAN OTC DRUG AHC Intense Contour Balm Moisture Methylhexy Methoxycinnamate CREAM TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd. OCTINOXATE .9 g/30mL 58930-024_e2f583ca-9f1f-4b27-96d5-f5e337822492 58930-024 HUMAN OTC DRUG AHC Revitalizing Special Gen Cream Niacinamide, Adenosine CREAM TOPICAL 20130710 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE; NIACINAMIDE 12; .6 mg/50mL; g/50mL 58930-025_1d522487-2dd0-4258-8bfc-926e2c25f069 58930-025 HUMAN OTC DRUG AHC Revitalizing Special Gen Mask Niacinamide, Adenosine LIQUID TOPICAL 20130710 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE; NIACINAMIDE 12.8; .64 mg/32g; g/32g 58930-026_4f88405a-cec4-484a-a9c4-0109d470ee78 58930-026 HUMAN OTC DRUG AHC Revitalizing Special Gen Solution Niacinamide, Adenosine LIQUID TOPICAL 20130710 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE; NIACINAMIDE 12; .6 mg/30mL; g/30mL 58930-027_20acb8bd-3d1e-4ef7-b163-4410f3ecaf5e 58930-027 HUMAN OTC DRUG AHC Revitalizing Special Gen Solution Niacinamide, Adenosine LIQUID TOPICAL 20130710 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE; NIACINAMIDE 54; 2.7 mg/135mL; g/135mL 58930-028_20ad2f83-5170-4cfc-bde6-58cc0ddaf5e7 58930-028 HUMAN OTC DRUG AHC Hydration Special Gen Cream Adenosine CREAM TOPICAL 20130715 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE 20 mg/50mL 58930-029_6a70bf7a-3ec8-469e-8dd8-ac00a68f3ca6 58930-029 HUMAN OTC DRUG AHC Hydration Special Gen Mask Adenosine LIQUID TOPICAL 20130715 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd. ADENOSINE 12.8 mg/32g 58930-030_2ebb3642-1617-4c05-9962-5d0bdcc69a09 58930-030 HUMAN OTC DRUG AHC Hydration Special Gen Serum Adenosine LIQUID TOPICAL 20130715 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE 12 mg/30mL 58930-031_82ac0e6e-c91b-4b3e-9398-476fc91f6b69 58930-031 HUMAN OTC DRUG AHC Hydration Special Gen Solution Adenosine LIQUID TOPICAL 20130715 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE 54 mg/135mL 58930-032_e5e0b303-5a27-4276-b361-cbe2e66cad03 58930-032 HUMAN OTC DRUG AHC Revitalizing Special Gen Cream Niacinamide CREAM TOPICAL 20130715 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd NIACINAMIDE .6 g/50mL 58930-035_35f1e2ec-dd69-4945-b858-0dbcec0b0559 58930-035 HUMAN OTC DRUG Capture Collagen Ampoule Niacinamide 2%, Adenosine 0.04% LIQUID TOPICAL 20130705 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE; NIACINAMIDE 20; 2 mg/50mL; g/50mL 58930-036_ced690fe-268d-43dc-8ed1-c4652ceaad05 58930-036 HUMAN OTC DRUG Capture C-Brightening Ampoule Niacinamide 2% LIQUID TOPICAL 20130705 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd NIACINAMIDE 2 g/50mL 58930-037_e5c5168e-859d-451c-962e-f58c1fd7c19d 58930-037 HUMAN OTC DRUG Capture Hyaluronic Ampoule Adenosine 0.04% LIQUID TOPICAL 20130705 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE 20 mg/50mL 58930-038_b63f45a6-b8ce-4ee1-90f9-ea0c5ad88045 58930-038 HUMAN OTC DRUG A.H.C. Collagen Cream Adenosine 0.04% CREAM TOPICAL 20130815 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE 20 mg/50mL 58930-039_8a121ba6-966e-4222-b048-f63f92956ed0 58930-039 HUMAN OTC DRUG A.H.C. Collagen Toner Adenosine 0.04% LIQUID TOPICAL 20130815 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE 48 mg/120mL 58930-040_b31638d3-4dd9-4831-bc8f-b51f96c7cd7f 58930-040 HUMAN OTC DRUG AHC Vital Complex C-15 Ampoule Arbutin 2%, Adenosine 0.04% LIQUID TOPICAL 20130815 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE; ARBUTIN 12; .6 mg/30mL; g/30mL 58930-041_8c6bed2b-098c-454b-a71a-1d9e393b334a 58930-041 HUMAN OTC DRUG AHC Phyto Complex Gel Ampoule Arbutin 2% LIQUID TOPICAL 20130815 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ARBUTIN .6 g/30mL 58930-042_fe48f877-02a0-4fdd-9994-a4988a3d7d40 58930-042 HUMAN OTC DRUG AHC Collagen Serum Adenosine 0.04% LIQUID TOPICAL 20130815 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE 12 mg/30mL 58930-043_4c29a92e-f6be-44e2-811f-92f5123ab78d 58930-043 HUMAN OTC DRUG AHC Vital C Complex Mask Niacinamide 2% LIQUID TOPICAL 20130815 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd NIACINAMIDE .6 g/30g 58930-044_a4c0262f-9880-4002-9151-ff8321ce283c 58930-044 HUMAN OTC DRUG AHC Vital C Complex Mask Adenosine 0.04% LIQUID TOPICAL 20130815 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE 12 mg/30g 58930-046_87af165c-e2da-4125-8bc3-91997b328495 58930-046 HUMAN OTC DRUG AHC Complex Choice EGF Booster Adenosine 0.04% CREAM TOPICAL 20130815 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE .4 mg/mL 58930-047_b3353383-5f92-4ebd-b4ee-70a9a4da24e1 58930-047 HUMAN OTC DRUG AHC Complex Choice EGF Booster Adenosine 0.04% CREAM TOPICAL 20130815 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE .4 mg/mL 58930-048_548c015d-10ce-4e0a-9913-f9faba90696f 58930-048 HUMAN OTC DRUG AHC Revitalizing Special Gen Serum Niacinamide, Adenosine LIQUID TOPICAL 20131005 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE; NIACINAMIDE 12; .6 mg/30mL; g/30mL 58930-050_a00ec490-9d1d-48d9-8646-d85a8fc46297 58930-050 HUMAN OTC DRUG AHC Premium Intense Contour Balm Titanium Dioxide, Talc,Ethylhexyl Methoxycinnamate, Arbutin, Zinc Oxide, Methicone, Aluminum Hydroxide, Aluminum Stearate, Adenosine CREAM TOPICAL 20140115 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE; ALUMINUM HYDROXIDE; ALUMINUM STEARATE; ARBUTIN; METHICONE (20 CST); OCTINOXATE; TALC; TITANIUM DIOXIDE; ZINC OXIDE .02; .45; .04; 1; 1.3; 1.5; 2.05; 3.96; .96 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL 58930-051_f08cf8d1-015e-4c69-aad3-af00d0bc6af7 58930-051 HUMAN OTC DRUG AHC Whitening Special Gen Cream Niacinamide CREAM TOPICAL 20130715 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd NIACINAMIDE .6 g/50mL 58930-052_2769b2b9-91f9-49de-9749-049dba23ea6d 58930-052 HUMAN OTC DRUG AHC Whitening Special Gen Serum Adenosine LIQUID TOPICAL 20130715 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd NIACINAMIDE 60 mg/30mL 58930-053_2e4686cf-8cfb-4b58-a885-489891b12a5b 58930-053 HUMAN OTC DRUG AHC Whitening Special Gen Solution Niacinamide LIQUID TOPICAL 20130710 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd NIACINAMIDE 2.4 g/120mL 58930-060_b8b15312-ad3c-47bb-be2d-e76cad5ad5af 58930-060 HUMAN OTC DRUG UV Capture Sebum Control Sun Cream ETHYLHEXYL METHOXYCINNAMATE, Zinc Oxide, Ethylhexy Salicate, TITANUIM DIOXIDE, Bis-ethylhexyloxyphenol methoxyphenyl triazine CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd 2-ETHYLHEXYL BENZOATE; BEMOTRIZINOL; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.25; .25; 3.4; 2.15; 2.5 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL 58930-060_fde0d994-6444-418d-95fe-c0dc773530be 58930-060 HUMAN OTC DRUG UV Capture Sebum Control Sun Cream ETHYLHEXYL METHOXYCINNAMATE, Zinc Oxide, Ethylhexy Salicate, TITANUIM DIOXIDE, Bis-ethylhexyloxyphenol methoxyphenyl triazine CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd 2-ETHYLHEXYL BENZOATE; BEMOTRIZINOL; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.25; .25; 3.4; 2.15; 2.5 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL 58930-061_3f316da8-8301-48e7-804f-81c0c2212fd1 58930-061 HUMAN OTC DRUG UV Capture Vita Sun Gel Ethylhexyl methoxycinnamate, Ethylhexy Salicate, Butyl Methoxydibezoylmethane GEL TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd 2-ETHYLHEXYL BENZOATE; AVOBENZONE; OCTINOXATE 2.25; 1.5; 3.5 g/50mL; g/50mL; g/50mL 58930-061_c6f5c96b-8611-4a74-a9e7-db4bdfe72cae 58930-061 HUMAN OTC DRUG UV Capture Vita Sun Gel Ethylhexyl methoxycinnamate, Ethylhexy Salicate, Butyl Methoxydibezoylmethane GEL TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd 2-ETHYLHEXYL BENZOATE; AVOBENZONE; OCTINOXATE 2.25; 1.5; 3.5 g/50mL; g/50mL; g/50mL 58930-062_27cd19e8-be65-4ce2-81fb-163a13a3d969 58930-062 HUMAN OTC DRUG UV Capture Sun BB Titnium Dioxide, Ethylhexyl Methoxycinnamate, Zinc Oxide CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; 2.37; .57 g/30mL; g/30mL; g/30mL 58930-062_9c6cf4d9-a69d-45d2-a050-3f84d8e58852 58930-062 HUMAN OTC DRUG UV Capture Sun BB Titnium Dioxide, Ethylhexyl Methoxycinnamate, Zinc Oxide CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; 2.37; .57 g/30mL; g/30mL; g/30mL 58930-063_21276566-87ec-4f87-a2c9-ae09f0d15de1 58930-063 HUMAN OTC DRUG UV Capture Water Zero Sunspray Ethylhexyl methoxycinnamate, Zinc Oxide, Titanium Dioxide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine SPRAY TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd BEMOTRIZINOL; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.75; 17.5; 10.25; 12.25 g/250mL; g/250mL; g/250mL; g/250mL 58930-063_48411540-fc74-45da-9057-daf0cc8748e9 58930-063 HUMAN OTC DRUG UV Capture Water Zero Sunspray Ethylhexyl methoxycinnamate, Zinc Oxide, Titanium Dioxide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine SPRAY TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd BEMOTRIZINOL; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.75; 17.5; 10.25; 12.25 g/250mL; g/250mL; g/250mL; g/250mL 58930-064_597a6a8a-2252-459a-8d60-64e980039a99 58930-064 HUMAN OTC DRUG UV Capture Sun Pact Titnium Dioxide, Ethylhexyl Methoxycinnamate, Octocrylene POWDER TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE .3; .09; .8 g/10g; g/10g; g/10g 58930-064_834e650a-15a9-40ac-92a3-b7c43e366b88 58930-064 HUMAN OTC DRUG UV Capture Sun Pact Titnium Dioxide, Ethylhexyl Methoxycinnamate, Octocrylene POWDER TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE .3; .09; .8 g/10g; g/10g; g/10g 58930-065_b9aa6a05-2925-464b-887f-01e4c7d6d027 58930-065 HUMAN OTC DRUG UV Capture Sun Pact Titnium Dioxide, Ethylhexyl Methoxycinnamate, Octocrylene POWDER TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE .3; .09; .8 g/10g; g/10g; g/10g 58933-829_3348bb37-696e-4e6c-bd0c-9c207529e168 58933-829 HUMAN OTC DRUG Crest Complete Multi-Benefit Extra Whitening with Tartar Protection Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufactura, S. de R.L. de C.V. SODIUM FLUORIDE 2.43 mg/g 58948-1001_14870feb-bce3-4fe2-8ebf-19dea7add407 58948-1001 HUMAN OTC DRUG Instant Hand Sanitizer KickPrints ETHYL ALCOHOL GEL TOPICAL 20130618 OTC MONOGRAPH NOT FINAL part333E Empire Stationery Distributors Inc. ALCOHOL 62 mL/100mL 58962-001_37c0bbc8-8785-4181-a636-177c7e4f9eba 58962-001 HUMAN OTC DRUG Tyra Tech Naturals Lice Treatment SODIUM CHLORIDE AEROSOL, FOAM TOPICAL 20130816 UNAPPROVED HOMEOPATHIC Tyra Tech, Inc. SODIUM CHLORIDE 2 [hp_X]/mL 58962-002_6b6fdac3-db92-4a8a-aa0e-35dad75ec19d 58962-002 HUMAN OTC DRUG Vamousse Lice Treatment Sodium Chloride AEROSOL, FOAM TOPICAL 20140224 UNAPPROVED HOMEOPATHIC Tyra Tech, Inc. SODIUM CHLORIDE 2 [hp_X]/mL 58962-003_7c915676-d20d-433c-b046-7f56647fc0e9 58962-003 HUMAN OTC DRUG Vamousse Lice Prevention SODIUM CHLORIDE SHAMPOO TOPICAL 20140116 UNAPPROVED HOMEOPATHIC TyraTech, Inc. SODIUM CHLORIDE 1 [hp_X]/mL 58964-101_6ee504e2-2477-4f12-89e5-77c500e52eb6 58964-101 HUMAN OTC DRUG BEEPROPOLIS Sodium monofluorophosphate PASTE, DENTIFRICE ORAL 20130701 OTC MONOGRAPH FINAL part355 Sinhwa Life Health Co Ltd SODIUM MONOFLUOROPHOSPHATE 100 mg/100g 58968-0001_96736ec5-5c25-4781-a2bf-88ba4fc52caa 58968-0001 HUMAN OTC DRUG VITANYA FREQUENCY DROPS NOT APPLICABLE LIQUID ORAL 20141030 UNAPPROVED HOMEOPATHIC Think Healthy Enterprises, LLC. CALCIUM IODIDE; ECHINACEA ANGUSTIFOLIA; NITRIC ACID; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; POTASSIUM CHLORIDE; SULFUR IODIDE; TRIFOLIUM PRATENSE FLOWER 12; 3; 12; 12; 3; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 58975-022_01043c5c-934e-4074-9540-156ef4324e24 58975-022 HUMAN OTC DRUG YINCHIAO ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE TABLET, FILM COATED ORAL 20110216 OTC MONOGRAPH FINAL part341 TIANJIN ZHONGXIN PHARMACEUTICAL GROUP CORP LTD LONGSHUNRONG PHARMACEUTICAL FACTORY ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 162.5; 1 mg/1; mg/1 58977-001_87c40f6e-fd23-432e-8e61-8d404054c820 58977-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19980101 UNAPPROVED MEDICAL GAS Rice Home Medical LLC OXYGEN 99 L/100L 58980-150_3649268d-3b2c-45a4-a0dc-0be069545ca8 58980-150 HUMAN PRESCRIPTION DRUG Hypercare ALUMINUM CHLORIDE HEXAHYDRATE and Alcohol SOLUTION TOPICAL 20080421 UNAPPROVED DRUG OTHER Stratus Pharamceuticals, Inc ALCOHOL; ALUMINUM CHLORIDE 3.75; 1 g/5mL; g/5mL 58980-200_8056349f-dbbe-4a78-b2e8-35b0c4e14db5 58980-200 HUMAN PRESCRIPTION DRUG Antipyrine and Benzocaine Antipyrine and Benzocaine SOLUTION AURICULAR (OTIC) 20140615 UNAPPROVED DRUG OTHER Stratus Pharmaceuticals ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 58980-330_9b4ff6b6-2976-4054-9aae-234aa726e925 58980-330 HUMAN PRESCRIPTION DRUG Cerisa SULFACETAMIDE SODIUM and SULFUR LOTION TOPICAL 20090406 UNAPPROVED OTHER Stratus Pharamceuticals, Inc SULFACETAMIDE SODIUM; SULFUR 100; 10 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 58980-335_e8ff4475-dba8-4a56-ba31-9e6a4cb27060 58980-335 HUMAN PRESCRIPTION DRUG Claris SULFACETAMIDE SODIUM and SULFUR EMULSION TOPICAL 20090216 UNAPPROVED OTHER Stratus Pharamceuticals, Inc SULFACETAMIDE SODIUM; SULFUR 100; 40 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 58980-336_30619f34-c4db-47b4-85a6-320451403b0d 58980-336 HUMAN PRESCRIPTION DRUG Zencia Wash SULFACETAMIDE SODIUM and SULFUR LOTION TOPICAL 20100810 UNAPPROVED DRUG OTHER Stratus Pharamceuticals, Inc SULFACETAMIDE SODIUM; SULFUR 90; 40 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 58980-340_205e7229-ce3d-4432-a687-cde71bb5614b 58980-340 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 10 Sulfur 5 Cleanser Sulfacetamide Sodium and Sulfur RINSE TOPICAL 20120430 UNAPPROVED DRUG OTHER Stratus Pharmaceuticals SULFACETAMIDE SODIUM; SULFUR 10; 5 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 58980-401_e13a0c9c-f829-4f47-bf48-1fa828f20873 58980-401 HUMAN OTC DRUG Vacuant Docusate Sodium ENEMA RECTAL 20110102 OTC MONOGRAPH NOT FINAL part334 Stratus Pharmaceuticals, Inc DOCUSATE SODIUM 283 mg/5mL 58980-402_582f8faa-f8b6-4e08-9124-8bfe1b6ee27c 58980-402 HUMAN OTC DRUG Vacuant Plus Docusate Sodium and Benzocaine ENEMA RECTAL 20120102 OTC MONOGRAPH NOT FINAL part334 Stratus Pharmaceuticals BENZOCAINE; DOCUSATE SODIUM 20; 283 mg/5mL; mg/5mL 58980-409_b37fb17f-3b60-4fe2-bf67-fc8b6b721fba 58980-409 HUMAN OTC DRUG Stratuscare Glycerin Laxative Pediatric Glycerin SUPPOSITORY RECTAL 20140601 OTC MONOGRAPH NOT FINAL part334 Stratus Pharmaceuticals GLYCERIN 1 g/1 58980-410_8ed41118-4f7c-463e-9060-d668fc9b9174 58980-410 HUMAN OTC DRUG Stratuscare Adult Glycerin Glycerin SUPPOSITORY RECTAL 20140530 OTC MONOGRAPH NOT FINAL part334 Stratus Pharmaceuticals GLYCERIN 2 g/1 58980-415_3b25df6c-a937-4956-9435-5c41b66c3ef9 58980-415 HUMAN OTC DRUG Stratuscare Bisacodyl Bisacodyl SUPPOSITORY RECTAL 20140530 OTC MONOGRAPH NOT FINAL part334 Stratus Pharmaceuticals BISACODYL 10 mg/1 58980-440_46d82013-b0d2-44ce-943a-178d4f9dc043 58980-440 HUMAN OTC DRUG Stratuscare Milk of Magnesia Sugar Free MAGNESIUM HYDROXIDE SUSPENSION ORAL 20140526 OTC MONOGRAPH NOT FINAL part334 Stratus Pharamceuticals MAGNESIUM HYDROXIDE 1200 mg/15mL 58980-441_53bcb3c6-a1e6-4032-b3b6-62a33b677d00 58980-441 HUMAN OTC DRUG Stratuscare Milk of Magnesia MAGNESIUM HYDROXIDE SUSPENSION ORAL 20140526 OTC MONOGRAPH NOT FINAL part334 Stratus Pharamceuticals MAGNESIUM HYDROXIDE 1200 mg/15mL 58980-442_50efe873-3cfb-41b7-917e-52ec1c433778 58980-442 HUMAN OTC DRUG Stratuscare Milk of Magnesia Cherry MAGNESIUM HYDROXIDE SUSPENSION ORAL 20140526 OTC MONOGRAPH NOT FINAL part334 Stratus Pharamceuticals MAGNESIUM HYDROXIDE 1200 mg/15mL 58980-450_b28ee0a2-70a8-4048-9a05-49aa44d9decc 58980-450 HUMAN OTC DRUG Stratuscare Antacid and Antigas ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, and SIMETHICONE SUSPENSION ORAL 20140426 OTC MONOGRAPH FINAL part332 Stratus Pharamceuticals ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 58980-451_28a84df2-ed1e-4171-a1f1-38f77e1518dc 58980-451 HUMAN OTC DRUG Stratuscare Antacid and Antigas Regular Strength DIMETHICONE, ALUMINUM HYDROXIDE, and MAGNESIUM HYDROXIDE SUSPENSION ORAL 20140426 OTC MONOGRAPH FINAL part332 Stratus Pharmaceuticals ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 58980-452_688e7b2c-d492-4838-a338-0c7c4bbc386a 58980-452 HUMAN OTC DRUG Stratuscare Antacid And Antigas DIMETHICONE, ALUMINUM HYDROXIDE, and MAGNESIUM HYDROXIDE SUSPENSION ORAL 20140426 OTC MONOGRAPH FINAL part332 Stratus Pharamceuticals ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 58980-472_031138cf-3596-454c-86ae-cef293d303e1 58980-472 HUMAN PRESCRIPTION DRUG Melquin Hp Hydroquinone CREAM TOPICAL 20020702 UNAPPROVED DRUG OTHER Stratus Pharmaceuticals HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 58980-473_6f584b1f-b61d-4b0c-83cc-371ebd2ace58 58980-473 HUMAN PRESCRIPTION DRUG Melpaque HP Hydroquinone CREAM TOPICAL 20010402 UNAPPROVED DRUG OTHER Stratus Pharmaceuticals HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 58980-475_6685425c-79a1-423e-8302-5630e1811d32 58980-475 HUMAN PRESCRIPTION DRUG Nuquin Hp Hydroquinone, Padimate O, and Dioxybenzone GEL TOPICAL 19990914 UNAPPROVED DRUG OTHER Stratus Pharmaceuticals DIOXYBENZONE; HYDROQUINONE; PADIMATE O 30; 40; 50 mg/g; mg/g; mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 58980-476_1228e67d-3ad2-4e37-b524-dbd4fc600957 58980-476 HUMAN PRESCRIPTION DRUG Melquin 3 Hydroquinone LIQUID TOPICAL 20021002 UNAPPROVED DRUG OTHER Stratus Pharmaceuticals HYDROQUINONE 30 mg/mL Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 58980-501_00d78a5f-46f3-4cf9-af4b-c85d373a9f9f 58980-501 HUMAN PRESCRIPTION DRUG Multi Vitamin Drops with Fluoride Vitamin A, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, and SODIUM FLUORIDE LIQUID ORAL 20140901 UNAPPROVED DRUG OTHER Stratus Pharmaceuticals .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A 5; 35; 400; 2; 8; .4; .6; .25; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 58980-502_a35eae19-cc09-45d3-b46f-7b6a340fd386 58980-502 HUMAN PRESCRIPTION DRUG Multi Vitamin Drops with Fluoride with Iron Vitamin A, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FERROUS SULFATE, and SODIUM FLUORIDE LIQUID ORAL 20140901 UNAPPROVED DRUG OTHER Stratus Pharmaceuticals .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; FERROUS SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A 5; 35; 400; 10; 8; .4; .6; .25; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 58980-503_f7c5b6b3-9c9d-4731-b4ac-56d0fad09525 58980-503 HUMAN PRESCRIPTION DRUG Multi-Vitamin Fluoride Vitamin A, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, and SODIUM FLUORIDE LIQUID ORAL 20140901 UNAPPROVED DRUG OTHER Stratus Pharmaceuticals .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A 5; 35; 400; 2; 8; .4; .6; .5; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 58980-504_c667cd2d-6ca4-4300-9a6d-c273ebe20d1c 58980-504 HUMAN PRESCRIPTION DRUG Triple Vitamin Drops with Fluoride Vitamin A, ASCORBIC ACID, CHOLECALCIFEROL, and SODIUM FLUORIDE LIQUID ORAL 20140901 UNAPPROVED DRUG OTHER Stratus Pharmaceuticals ASCORBIC ACID; CHOLECALCIFEROL; SODIUM FLUORIDE; VITAMIN A 35; 400; .25; 1500 mg/mL; [iU]/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 58980-574_224f7234-78df-4bde-81bd-f7f271856e9b 58980-574 HUMAN PRESCRIPTION DRUG Nuquin Hp Hydroquinone, Padimate O, Dioxybenzone, and Oxybenzone CREAM TOPICAL 20031209 UNAPPROVED DRUG OTHER Stratus Pharmaceuticals DIOXYBENZONE; HYDROQUINONE; OXYBENZONE; PADIMATE O 30; 40; 20; 80 mg/g; mg/g; mg/g; mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 58980-580_3e4a068b-441d-4c81-a108-990a06f80f1c 58980-580 HUMAN PRESCRIPTION DRUG Alphaquin HP Hydroquinone, Octinoxate, and Oxybenzone CREAM TOPICAL 19930101 UNAPPROVED DRUG OTHER Stratus Pharamceuticals HYDROQUINONE; OCTINOXATE; OXYBENZONE 40; 75; 50 mg/g; mg/g; mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 58980-605_4870b185-38b8-47cf-a816-f6a4d661b179 58980-605 HUMAN PRESCRIPTION DRUG Urea Urea CREAM TOPICAL 20100501 UNAPPROVED DRUG OTHER Stratus Pharmaceuticals, Inc UREA 8.5 g/85g 58980-608_b27e4171-7de6-4736-a055-54288ac64d15 58980-608 HUMAN OTC DRUG Urea Urea LOTION TOPICAL 20100520 UNAPPROVED DRUG OTHER Stratus Pharmaceuticals, Inc UREA 1 mL/10mL 58980-610_450898ac-ec56-4cc7-a18f-f65b12e5aa65 58980-610 HUMAN OTC DRUG Urea Urea CREAM TOPICAL 20081031 UNAPPROVED OTHER Stratus Pharamceuticals, Inc UREA 17 g/85g 58980-615_72b4d6f0-fd9f-40b1-b6e2-059dd7ae5d93 58980-615 HUMAN OTC DRUG Arctic Relief Menthol and Camphor (Synthetic) GEL TOPICAL 20091001 OTC MONOGRAPH FINAL part341 Stratus Pharmaceuticals, Inc CAMPHOR (SYNTHETIC); MENTHOL .2268; 3.969 g/113.4g; g/113.4g 58980-623_887f55cf-3d43-49b7-9a58-ad5f64fec37c 58980-623 HUMAN PRESCRIPTION DRUG X Viate Urea LOTION TOPICAL 20090901 UNAPPROVED OTHER Stratus Pharamceuticals, Inc UREA 94.8 mg/237mL 58980-624_e8dc3f0c-b8e6-450f-8cf6-b2f2d487dfcf 58980-624 HUMAN PRESCRIPTION DRUG X-Viate Urea GEL TOPICAL 20060503 UNAPPROVED DRUG OTHER Stratus Pharmaceuticals, Inc UREA 6.726 g/15mL 58980-625_50e267ed-4434-4b28-91bb-cbcd86ed89d2 58980-625 HUMAN PRESCRIPTION DRUG X Viate Urea CREAM TOPICAL 20050411 UNAPPROVED DRUG OTHER Stratus Pharamceuticals, Inc UREA .4 g/g 58980-630_886726ec-1b2a-4ad3-9231-60709bacd958 58980-630 HUMAN PRESCRIPTION DRUG Salacyn Salicylic Acid LOTION TOPICAL 20090323 UNAPPROVED DRUG OTHER Stratus Pharamceuticals, Inc SALICYLIC ACID 24.84 mg/414mL 58980-631_886726ec-1b2a-4ad3-9231-60709bacd958 58980-631 HUMAN PRESCRIPTION DRUG Salacyn Salicylic Acid CREAM TOPICAL 20090323 UNAPPROVED DRUG OTHER Stratus Pharamceuticals, Inc SALICYLIC ACID 24 g/400g 58980-680_f16a44a1-3597-48ff-b818-cad3a42478ef 58980-680 HUMAN PRESCRIPTION DRUG Remeven Urea CREAM TOPICAL 20080618 UNAPPROVED DRUG OTHER Stratus Pharmaceuticals, Inc UREA 71 g/142g 58980-777_2c24a31a-9e0b-40db-815d-95724d5e7137 58980-777 HUMAN PRESCRIPTION DRUG Latrix Urea SUSPENSION TOPICAL 20081014 UNAPPROVED OTHER Stratus Pharmaceuticals, Inc UREA 142 g/284g 58980-780_ae718f2b-8848-4f0c-b556-1561a3524c8f 58980-780 HUMAN PRESCRIPTION DRUG Venelex Castor Oil and Balsam, Peru OINTMENT TOPICAL 20091129 UNAPPROVED DRUG OTHER Stratus Pharamceuticals, Inc BALSAM, PERU; CASTOR OIL 87; 788 mg/g; mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 58980-790_c3a996d9-461b-46cd-8515-bedf2f24f6bc 58980-790 HUMAN PRESCRIPTION DRUG Vasolex Trypsin, Castor Oil, and Balsam Peru OINTMENT TOPICAL 20070207 UNAPPROVED DRUG OTHER Stratus Pharmacuticals BALSAM PERU; CASTOR OIL; TRYPSIN 87; 788; 90 mg/g; mg/g; [USP'U]/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 58980-811_c501f889-b6a1-4af7-8acb-e154e19dfe3c 58980-811 HUMAN PRESCRIPTION DRUG Dermazene hydrocortisone and Iodoquinol CREAM TOPICAL 20010611 UNAPPROVED DRUG OTHER Stratus Pharamceuticals, Inc HYDROCORTISONE; IODOQUINOL 10; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 58980-818_98954136-ca0b-43cd-ac80-f230097a4767 58980-818 HUMAN OTC DRUG Azolen Miconazole Nitrate TINCTURE TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part333C Stratus Pharmaceuticals, Inc. MICONAZOLE NITRATE 20 mg/mL 58980-820_e053c409-97b8-4ad6-9edf-4856c1635ac3 58980-820 HUMAN OTC DRUG Castellani Paint Phenol LIQUID TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Stratus Pharamceuticals PHENOL 15 mg/mL 58980-822_adb7a8f8-57b9-426c-a1e5-6d0285d85f10 58980-822 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride LOTION TOPICAL 20120301 UNAPPROVED DRUG OTHER Stratus Pharamceuticals LIDOCAINE HYDROCHLORIDE 5.31 mL/177mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 58980-890_13fb16ae-e9db-44fb-aa2f-9c818c224307 58980-890 HUMAN OTC DRUG Pazol XS Salicylic Acid, Sulfur, and Coal Tar SHAMPOO TOPICAL 20110701 UNAPPROVED DRUG OTHER Stratus Pharamceuticals, Inc COAL TAR; SALICYLIC ACID; SULFUR .5; 20; 20 mg/mL; mg/mL; mg/mL 58980-915_2a40e72c-b143-4e50-9e8d-90f600845e84 58980-915 HUMAN PRESCRIPTION DRUG Lactic Acid Lactic Acid CREAM TOPICAL 20090116 UNAPPROVED OTHER Stratus Pharamceuticals, Inc LACTIC ACID 11.34 g/113.4g 58980-918_5adf0746-b5c5-487c-b9d9-2d5620d8f87a 58980-918 HUMAN PRESCRIPTION DRUG Lactic Acid Lactic Acid LOTION TOPICAL 20090108 UNAPPROVED OTHER Stratus Pharamceuticals, Inc LACTIC ACID 35.484 mL/354.84mL 58982-010_c98056df-159d-49f7-967e-0f43cd9af8d9 58982-010 HUMAN OTC DRUG OZ TREE HandMade by Dorothy Allantoin SOAP TOPICAL 20130701 OTC MONOGRAPH FINAL part347 OZ SOAP TREE ALLANTOIN .55 g/110g 58986-010_1ee904da-8395-489b-86b1-e1450edf5162 58986-010 HUMAN OTC DRUG FUCOIDAN SKINCURE Allantoin SPRAY TOPICAL 20130601 OTC MONOGRAPH FINAL part347 SAMDAONE ALLANTOIN 1.2 g/100g 58986-020_0a9c143b-eddc-44ed-a7da-452dc470a14b 58986-020 HUMAN OTC DRUG FUCOIDAN ESSENCE Allantoin CREAM TOPICAL 20130601 OTC MONOGRAPH FINAL part347 SAMDAONE ALLANTOIN 1 g/50g 58986-030_8baa8ec9-0d0b-47f3-b74f-ef5788e2eb44 58986-030 HUMAN OTC DRUG FUCOIDAN HAIR TONIC Allantoin SPRAY TOPICAL 20130601 OTC MONOGRAPH FINAL part347 SAMDAONE ALLANTOIN .3 g/60g 58987-001_e7ce6a0d-13d7-4463-b3e2-1081dab99a46 58987-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Enos Home Oxygen Therapy, Inc. OXYGEN 99.5 L/100L 58988-0018_de5b12b7-cb4f-483e-8a0a-baaf8d3c89f6 58988-0018 HUMAN OTC DRUG Redness reliever and Lubricant dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl LIQUID OPHTHALMIC 20131206 OTC MONOGRAPH FINAL part349 Promex, LLC DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL 58988-0019_1fd48759-eb0f-40f6-8298-d88ae84089e5 58988-0019 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part348 Promex, LLC HYDROCORTISONE 1 g/100g 58988-0022_5b99775b-1586-4fd8-9466-0ab91ac5b223 58988-0022 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20131204 OTC MONOGRAPH FINAL part333C Promex, LLC CLOTRIMAZOLE 1 g/100g 58988-0031_f1eac575-6602-4a06-a863-647497d835f0 58988-0031 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20131202 OTC MONOGRAPH FINAL part333B Promex, LLC BACITRACIN ZINC 500 [USP'U]/g 58988-0038_3c0ddae5-1273-482b-8fa8-f8b88a99a956 58988-0038 HUMAN OTC DRUG Antibiotic Neomycin sulfate OINTMENT TOPICAL 20131205 OTC MONOGRAPH FINAL part333B Promex, LLC NEOMYCIN SULFATE 3.5 mg/g 58988-0148_b776833e-2216-4e51-aee0-e80aa0a44ae5 58988-0148 HUMAN OTC DRUG T-RAOJO tetrahydrozoline Hydrochloride LIQUID OPHTHALMIC 20140717 OTC MONOGRAPH FINAL part349 Promex, LLC TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 58988-0184_4315aea0-67db-4a88-b6c6-2908555a997f 58988-0184 HUMAN OTC DRUG Saline Nasal Sodium chloride SPRAY NASAL 20131209 UNAPPROVED DRUG OTHER Promex, LLC SODIUM CHLORIDE 6.5 mg/mL 58988-0193_6b63b9a2-bc68-4472-a3d3-d973e4c28aec 58988-0193 HUMAN OTC DRUG Nasal Decongestant Oxymetazoline HCl SPRAY NASAL 20131209 OTC MONOGRAPH FINAL part341 Promex, LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 58990-000_733391bf-a753-4a09-9e20-a881a7f16368 58990-000 HUMAN OTC DRUG Antiac Acne Clearing Salicylic Acid SPRAY TOPICAL 20130713 OTC MONOGRAPH FINAL part333D Salcura Ltd SALICYLIC ACID 5 mg/mL 59002-112_4a4dc9d6-13e1-4a5a-9916-3882818a7440 59002-112 HUMAN OTC DRUG Nail Active Daytime Anti-fungal Tolnaftate LOTION TOPICAL 20140317 OTC MONOGRAPH FINAL part333C Harvest Trading Group Inc. TOLNAFTATE 100 g/g 59011-255_000853a2-c598-4bc6-9aa8-61c3afa66173 59011-255 HUMAN PRESCRIPTION DRUG Intermezzo zolpidem tartrate TABLET SUBLINGUAL 20120405 NDA NDA022328 Purdue Pharma LP ZOLPIDEM TARTRATE 3.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 59011-256_000853a2-c598-4bc6-9aa8-61c3afa66173 59011-256 HUMAN PRESCRIPTION DRUG Intermezzo zolpidem tartrate TABLET SUBLINGUAL 20120405 NDA NDA022328 Purdue Pharma LP ZOLPIDEM TARTRATE 1.75 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 59011-260_a366231a-a7f3-4761-69d5-1a7cee761b7b 59011-260 HUMAN PRESCRIPTION DRUG MS Contin morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870701 NDA NDA019516 Purdue Pharma LP MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-261_a366231a-a7f3-4761-69d5-1a7cee761b7b 59011-261 HUMAN PRESCRIPTION DRUG MS Contin morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870701 NDA NDA019516 Purdue Pharma LP MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-262_a366231a-a7f3-4761-69d5-1a7cee761b7b 59011-262 HUMAN PRESCRIPTION DRUG MS Contin morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870701 NDA NDA019516 Purdue Pharma LP MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-263_a366231a-a7f3-4761-69d5-1a7cee761b7b 59011-263 HUMAN PRESCRIPTION DRUG MS Contin morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870701 NDA NDA019516 Purdue Pharma LP MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-264_a366231a-a7f3-4761-69d5-1a7cee761b7b 59011-264 HUMAN PRESCRIPTION DRUG MS Contin morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870701 NDA NDA019516 Purdue Pharma LP MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-410_f768f011-8545-f999-0d8f-56ad304547c4 59011-410 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Purdue Pharma LP OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-415_f768f011-8545-f999-0d8f-56ad304547c4 59011-415 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Purdue Pharma LP OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-420_f768f011-8545-f999-0d8f-56ad304547c4 59011-420 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Purdue Pharma LP OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-430_f768f011-8545-f999-0d8f-56ad304547c4 59011-430 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Purdue Pharma LP OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-440_f768f011-8545-f999-0d8f-56ad304547c4 59011-440 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Purdue Pharma LP OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-441_6c32ad1e-9e87-4c9d-818b-75dae01cdbd6 59011-441 HUMAN PRESCRIPTION DRUG Dilaudid hydromorphone hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19260101 NDA NDA019034 Purdue Pharma LP HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-442_6c32ad1e-9e87-4c9d-818b-75dae01cdbd6 59011-442 HUMAN PRESCRIPTION DRUG Dilaudid hydromorphone hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19260101 NDA NDA019034 Purdue Pharma LP HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-444_6c32ad1e-9e87-4c9d-818b-75dae01cdbd6 59011-444 HUMAN PRESCRIPTION DRUG Dilaudid hydromorphone hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19260101 NDA NDA019034 Purdue Pharma LP HYDROMORPHONE HYDROCHLORIDE 4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-445_6c32ad1e-9e87-4c9d-818b-75dae01cdbd6 59011-445 HUMAN PRESCRIPTION DRUG Dilaudid HP hydromorphone hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19840111 NDA NDA019034 Purdue Pharma LP HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-446_6c32ad1e-9e87-4c9d-818b-75dae01cdbd6 59011-446 HUMAN PRESCRIPTION DRUG Dilaudid HP hydromorphone hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19840111 NDA NDA019034 Purdue Pharma LP HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-451_6baf4ef4-d7b0-4420-8d11-c9f24b8af0c2 59011-451 HUMAN PRESCRIPTION DRUG DILAUDID HYDROMORPHONE HYDROCHLORIDE LIQUID ORAL 19560101 NDA NDA019891 Purdue Pharma LP HYDROMORPHONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-452_6baf4ef4-d7b0-4420-8d11-c9f24b8af0c2 59011-452 HUMAN PRESCRIPTION DRUG DILAUDID HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 19560101 NDA NDA019892 Purdue Pharma LP HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-454_6baf4ef4-d7b0-4420-8d11-c9f24b8af0c2 59011-454 HUMAN PRESCRIPTION DRUG DILAUDID HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 19560101 NDA NDA019892 Purdue Pharma LP HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-458_6baf4ef4-d7b0-4420-8d11-c9f24b8af0c2 59011-458 HUMAN PRESCRIPTION DRUG DILAUDID HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 19560101 NDA NDA019892 Purdue Pharma LP HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-460_f768f011-8545-f999-0d8f-56ad304547c4 59011-460 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Purdue Pharma LP OXYCODONE HYDROCHLORIDE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-480_f768f011-8545-f999-0d8f-56ad304547c4 59011-480 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Purdue Pharma LP OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59011-750_c3540bd8-98fd-4bcb-ae9d-9168ad9933b1 59011-750 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20110214 NDA NDA021306 Purdue Pharma LP BUPRENORPHINE 5 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 59011-751_c3540bd8-98fd-4bcb-ae9d-9168ad9933b1 59011-751 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20110214 NDA NDA021306 Purdue Pharma LP BUPRENORPHINE 10 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 59011-752_c3540bd8-98fd-4bcb-ae9d-9168ad9933b1 59011-752 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20110214 NDA NDA021306 Purdue Pharma LP BUPRENORPHINE 20 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 59011-757_c3540bd8-98fd-4bcb-ae9d-9168ad9933b1 59011-757 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20110214 NDA NDA021306 Purdue Pharma LP BUPRENORPHINE 7.5 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 59011-758_c3540bd8-98fd-4bcb-ae9d-9168ad9933b1 59011-758 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20110214 NDA NDA021306 Purdue Pharma LP BUPRENORPHINE 15 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 59021-001_87785124-51ce-40fb-aedd-192bf9c6db9a 59021-001 HUMAN OTC DRUG Candy Apple Anti Bacterial Foaming Hand TRICLOSAN LIQUID TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333E Five Below TRICLOSAN .3 g/100mL 59021-002_bb2303fc-651b-413d-be86-9119e15b5cd5 59021-002 HUMAN OTC DRUG Caribbean Escape Anti Bacterial Foaming Hand TRICLOSAN LIQUID TOPICAL 20130413 OTC MONOGRAPH NOT FINAL part333E Five Below TRICLOSAN .3 g/100mL 59021-003_1a5c07fb-e0a7-445a-97ca-8b1773631147 59021-003 HUMAN OTC DRUG Cotton Candy Anti Bacterial Foaming Hand TRICLOSAN LIQUID TOPICAL 20130413 OTC MONOGRAPH NOT FINAL part333E Five Below TRICLOSAN .3 g/100mL 59021-004_6afdd58b-0249-4c0b-abc2-72161e5b15f0 59021-004 HUMAN OTC DRUG Mango Madness Anti Bacterial Foaming Hand TRICLOSAN LIQUID TOPICAL 20130413 OTC MONOGRAPH NOT FINAL part333E Five Below TRICLOSAN .3 g/100mL 59021-005_4184ed08-d723-4db8-95d5-4b99dfe3ec58 59021-005 HUMAN OTC DRUG Vanilla Cupcake Anti Bacterial Foaming Hand TRICLOSAN LIQUID TOPICAL 20130413 OTC MONOGRAPH NOT FINAL part333E Five Below TRICLOSAN .3 g/100mL 59021-006_273d0ab2-ef18-4d23-a720-f0e82137203a 59021-006 HUMAN OTC DRUG Fresh Picked Strawberries Anti Bacterial Foaming Hand TRICLOSAN LIQUID TOPICAL 20130413 OTC MONOGRAPH NOT FINAL part333E Five Below TRICLOSAN .3 g/100mL 59021-007_acc69bf5-f86d-4999-ba3d-5539017680ab 59021-007 HUMAN OTC DRUG Fresh Picked Strawberries Anti Bacterial Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333E Five Below BENZETHONIUM CHLORIDE .13 g/100mL 59021-008_d193d79d-23bb-4403-8749-3c39d3074688 59021-008 HUMAN OTC DRUG Caribbean Escape Anti Bacterial Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333E Five Below BENZETHONIUM CHLORIDE .13 g/100mL 59021-009_e0ccaa60-e66f-4a7e-a7c2-a3a24352ce6b 59021-009 HUMAN OTC DRUG Cotton Candy Anti Bacterial Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333E Five Below BENZETHONIUM CHLORIDE .13 g/100mL 59021-010_b5938a42-57de-40da-a966-9c89ec3e5b0b 59021-010 HUMAN OTC DRUG Candy Apple Anti Bacterial Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333E Five Below BENZETHONIUM CHLORIDE .13 g/100mL 59021-011_fccd85f9-2905-4474-a560-3a54e674fe22 59021-011 HUMAN OTC DRUG Vanilla Cupcake Anti Bacterial Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333E Five Below BENZETHONIUM CHLORIDE .13 g/100mL 59021-012_f9a7e010-a0fa-4f01-88c6-64fdadf0ccb7 59021-012 HUMAN OTC DRUG Mango Madness Anti Bacterial Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333E Five Below BENZETHONIUM CHLORIDE .13 g/100mL 59039-001_f7e15660-f0d7-49df-9942-59119a6bdf3e 59039-001 HUMAN OTC DRUG Obao Frescura Floral Aluminum Chlorohydrate LIQUID TOPICAL 20130619 OTC MONOGRAPH FINAL part350 Cosbel S.A de C.V. ALUMINUM CHLOROHYDRATE 15 g/100g 59039-002_d2b30f12-5da7-4a24-9f1c-00be11285e06 59039-002 HUMAN OTC DRUG Obao Men Audaz Aluminum Chlorohydrate LIQUID TOPICAL 20130619 OTC MONOGRAPH FINAL part350 Cosbel S.A de C.V. ALUMINUM CHLOROHYDRATE 15 g/100g 59039-003_5f9ae274-6bf4-4d68-bf58-31addc7faa78 59039-003 HUMAN OTC DRUG Obao Men Active Aluminum Chlorohydrate LIQUID TOPICAL 20130619 OTC MONOGRAPH FINAL part350 Cosbel S.A de C.V. ALUMINUM CHLOROHYDRATE 15 g/100g 59039-004_22af212c-1ed2-40fb-8bdf-3e79b0a160b6 59039-004 HUMAN OTC DRUG Obao Piel Delicada Aluminum Chlorohydrate LIQUID TOPICAL 20130619 OTC MONOGRAPH FINAL part350 Cosbel S.A de C.V. ALUMINUM CHLOROHYDRATE 15 g/100g 59039-005_3a668d22-bb56-4f36-8f3e-4c5cbc644eda 59039-005 HUMAN OTC DRUG Obao Frescura Suave Aluminum Chlorohydrate LIQUID TOPICAL 20130619 OTC MONOGRAPH FINAL part350 Cosbel S.A de C.V. ALUMINUM CHLOROHYDRATE 15 g/100g 59039-006_2007b6dd-0c12-4422-8dcf-1c3138166a8c 59039-006 HUMAN OTC DRUG Obao Frescura Intensa Aluminum Chlorohydrate LIQUID TOPICAL 20130619 OTC MONOGRAPH FINAL part350 Cosbel S.A de C.V. ALUMINUM CHLOROHYDRATE 15 g/100g 59045-1001_9a5df0c9-d52a-441e-9b5c-05132d261900 59045-1001 HUMAN OTC DRUG Anti-Bacterial Hand Gel Apple Pie ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL 59045-1002_1f8ebd59-2f13-4739-b5ec-72e6711f1798 59045-1002 HUMAN OTC DRUG Anti-Bacterial Hand Gel Pink Lemonade ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL 59045-1003_d3a76b68-6259-44ec-9847-7c18c98b7f59 59045-1003 HUMAN OTC DRUG Anti-Bacterial Hand Gel Candy Apple ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL 59045-1004_a688a6d1-099a-43db-874f-4a234e659f65 59045-1004 HUMAN OTC DRUG Anti-Bacterial Hand Gel Sweet Pea ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL 59045-1005_28e01cef-4673-456d-944a-78dd656cb085 59045-1005 HUMAN OTC DRUG Anti-Bacterial Hand Gel Fresh Picked Strawberries ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL 59045-1006_213952da-7173-41fa-93ea-85e94f88ad96 59045-1006 HUMAN OTC DRUG Anti-Bacterial Hand Gel Caribbean Escape ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL 59045-1007_e745f5b7-729d-47ff-928a-4c711c7f8226 59045-1007 HUMAN OTC DRUG Anti-Bacterial Hand Gel Vanilla Cupcake ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL 59045-1008_1b78b099-f3f2-46c4-83e9-c52dae89d329 59045-1008 HUMAN OTC DRUG Anti-Bacterial Hand Gel Mango Madness ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL 59045-1009_6f1e71be-ba38-4605-8820-2b1f27c9f422 59045-1009 HUMAN OTC DRUG Anti-Bacterial Hand Gel Cotton Candy ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL 59048-000_6af59a2d-061e-43ab-990b-8c58f280484a 59048-000 HUMAN OTC DRUG ASSURE Antiseptic Hand Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130819 OTC MONOGRAPH NOT FINAL part333E San Jamar, Inc BENZALKONIUM CHLORIDE .12 g/100g 59050-242_7567d0f9-2fa4-49ba-a13e-3ae65b5e348a 59050-242 HUMAN OTC DRUG MK Alcohol Swabstick Sterile ISOPROPYL ALCOHOL LIQUID TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A Changzhou Maokang Medical Products Co., Ltd ISOPROPYL ALCOHOL 70 mL/100mL 59050-244_37ff8dde-6a1b-47e1-9622-1aadd6e8cef4 59050-244 HUMAN OTC DRUG MK Alcohol Swabstick Sterile ISOPROPYL ALCOHOL LIQUID TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A Changzhou Maokang Medical Products Co., Ltd ISOPROPYL ALCOHOL 70 mL/100mL 59050-251_943e5ee9-d169-4656-9154-72373ef0bf20 59050-251 HUMAN OTC DRUG MK Povidone-Iodine Swabstick Non-Sterile POVIDONE-IODINE GEL TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part333E Changzhou Maokang Medical Products Co., Ltd POVIDONE-IODINE 10 mg/mL 59050-251_96c4bb95-2a80-4107-9cb1-94e0266a1815 59050-251 HUMAN OTC DRUG MK Povidone-Iodine Swabstick Sterile POVIDONE-IODINE LIQUID TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333E Changzhou Maokang Medical Products Co., Ltd POVIDONE-IODINE 100 mg/mL 59050-254_5604b541-8315-4f66-a18d-957a1fa7e576 59050-254 HUMAN OTC DRUG MK Povidone-Iodine Swabstick Non-Sterile POVIDONE-IODINE LIQUID TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part333E Changzhou Maokang Medical Products Co., Ltd POVIDONE-IODINE 10 mg/mL 59050-254_981303ac-7241-4f0d-b7db-cce764fec1f8 59050-254 HUMAN OTC DRUG MK Povidone-Iodine Swabstick Sterile POVIDONE-IODINE LIQUID TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333E Changzhou Maokang Medical Products Co., Ltd POVIDONE-IODINE 100 mg/mL 59050-331_d16d97cf-c821-44f4-91cf-bc16a3081c4e 59050-331 HUMAN OTC DRUG MK BZK Antiseptic Towelette Sterile BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333E Changzhou Maokang Medical Products Co., Ltd BENZALKONIUM CHLORIDE 1.3 mg/mL 59050-331_fbda4e53-59b3-446a-9974-08b258052c09 59050-331 HUMAN OTC DRUG MK BZK Antiseptic Towelette Non-Sterile BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part333E Changzhou Maokang Medical Products Co., Ltd BENZALKONIUM CHLORIDE 1.3 mg/mL 59050-414_d3bd3655-dd9f-4869-9b0d-0b1904e2022e 59050-414 HUMAN OTC DRUG MK Sting Relief Pads BENZOCAINE, ISOPROPYL ALCOHOL LIQUID TOPICAL 20140609 OTC MONOGRAPH NOT FINAL part333A Changzhou Maokang Medical Products Co., Ltd BENZOCAINE; ISOPROPYL ALCOHOL 6; 60 mg/mL; mL/mL 59050-434_4e820c7d-dcd1-4388-8db8-2583fa5a9b60 59050-434 HUMAN OTC DRUG MK BZK Swab Sterile BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333E Changzhou Maokang Medical Products Co., Ltd BENZALKONIUM CHLORIDE 1.3 mg/mL 59050-434_90b99635-bc9d-4173-9f33-08c8ae033eb2 59050-434 HUMAN OTC DRUG MK BZK Swab Non-Sterile BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part333E Changzhou Maokang Medical Products Co., Ltd BENZALKONIUM CHLORIDE 1.3 mg/mL 59050-444_35c3cfcb-2b25-4538-be29-1bbae0def269 59050-444 HUMAN OTC DRUG MK Alcohol Prep Pads Medium ISOPROPYL ALCOHOL LIQUID TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A Changzhou Maokang Medical Products Co., Ltd ISOPROPYL ALCOHOL 70 mL/100mL 59050-444_87072da7-86bf-4d1f-8de3-c2cd0116c1fe 59050-444 HUMAN OTC DRUG MK Alcohol Prep Pads Medium ISOPROPYL ALCOHOL LIQUID TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A Changzhou Maokang Medical Products Co., Ltd ISOPROPYL ALCOHOL 70 mL/100mL 59050-448_124daba7-e441-4c21-ad06-998de1ddf6db 59050-448 HUMAN OTC DRUG MK Alcohol Prep Pads Large ISOPROPYL ALCOHOL LIQUID TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A Changzhou Maokang Medical Products Co., Ltd ISOPROPYL ALCOHOL 70 mL/100mL 59050-448_ce80953c-6d6e-459f-8c21-45011916caa9 59050-448 HUMAN OTC DRUG MK Alcohol Prep Pads Large ISOPROPYL ALCOHOL LIQUID TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part333A Changzhou Maokang Medical Products Co., Ltd ISOPROPYL ALCOHOL 70 mL/100mL 59054-000_8025c0e7-fa99-4579-8139-f3201505960c 59054-000 HUMAN OTC DRUG Academy Sports Outdoors SUNSCREEN CONTINUOUS SPORT BROAD SPECTRUM SPF 50 Water-Resistant AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20130514 OTC MONOGRAPH NOT FINAL part352 Academy Ltd AVOBENZONE; OCTOCRYLENE; OXYBENZONE 30; 100; 50 mg/mL; mg/mL; mg/mL 59054-001_501d974d-9209-4b15-b20d-a200425ce525 59054-001 HUMAN OTC DRUG Academy Sports Outdoors SUNSCREEN CONTINUOUS BROAD SPECTRUM SPF 50 Water-Resistant AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20130514 OTC MONOGRAPH NOT FINAL part352 Academy Ltd AVOBENZONE; OCTOCRYLENE; OXYBENZONE 30; 100; 50 mg/mL; mg/mL; mg/mL 59054-110_a56e42d5-8c85-4553-93c5-a0572cebe45d 59054-110 HUMAN OTC DRUG Academy Sport SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130628 OTC MONOGRAPH NOT FINAL part352 ACADEMY, LTD AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g 59054-120_7bbcdb59-052d-4c5f-acc4-71843139511b 59054-120 HUMAN OTC DRUG Academy SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130628 OTC MONOGRAPH NOT FINAL part352 ACADEMY, LTD AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g 59054-140_a9b2e101-4fed-4ed9-9050-ee7f20651612 59054-140 HUMAN OTC DRUG Academy Continuous SPF 50 AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 ACADEMY, LTD AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 10; 5 g/100g; g/100g; g/100g 59054-141_83a51487-6507-4e27-975b-7fc00e0a86fa 59054-141 HUMAN OTC DRUG Academy Continuous Sport SPF 50 AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20130827 OTC MONOGRAPH NOT FINAL part352 ACADEMY, LTD AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 10; 5 g/100g; g/100g; g/100g 59054-370_1e15083c-59ad-4b55-a6d4-f51625e08cb4 59054-370 HUMAN OTC DRUG Academy Sport SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130628 OTC MONOGRAPH NOT FINAL part352 ACADEMY, LTD AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g 59062-1003_71b8b60c-396d-4fd5-8a77-83a1fac0cce5 59062-1003 HUMAN OTC DRUG BabyGanics Alcohol Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333E KAS Direct LLC dba BabyGanics BENZALKONIUM CHLORIDE .1 mg/mL 59062-1005_71b8b60c-396d-4fd5-8a77-83a1fac0cce5 59062-1005 HUMAN OTC DRUG BabyGanics Alcohol Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333E KAS Direct LLC dba BabyGanics BENZALKONIUM CHLORIDE .1 mg/mL 59062-1044_14bc1bd5-84e7-490b-acd1-0a5e7b8251d1 59062-1044 HUMAN OTC DRUG BabyGanics Alcohol Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333E KAS Direct LLC dba BabyGanics BENZALKONIUM CHLORIDE .1 mg/mL 59062-1062_b8e8a4df-1d20-4895-b5b1-f6c0f0d51d29 59062-1062 HUMAN OTC DRUG BabyGanics Alcohol Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333E KAS Direct LLC dba BabyGanics BENZALKONIUM CHLORIDE .1 mg/mL 59062-1068_b8e8a4df-1d20-4895-b5b1-f6c0f0d51d29 59062-1068 HUMAN OTC DRUG BabyGanics Alcohol Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333E KAS Direct LLC dba BabyGanics BENZALKONIUM CHLORIDE .1 mg/mL 59062-1207_ee31f055-bb9e-4a25-b08c-107d3561d728 59062-1207 HUMAN OTC DRUG BabyGanics Sunscreen 50 SPF OCTINOXATE, OCTISALATE, and ZINC OXIDE SPRAY TOPICAL 20130621 OTC MONOGRAPH NOT FINAL part352 KAS Direct LLC dba BabyGanics OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 50; 112 mg/mL; mg/mL; mg/mL 59062-1210_55a69461-6b0b-4876-bae6-9db2d9c1fdb1 59062-1210 HUMAN OTC DRUG BabyGanics Sunscreen 50SPF OCTINOXATE, OCTISALATE, and ZINC OXIDE LOTION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 KAS Direct LLC dba BabyGanics OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 50; 117 mg/mL; mg/mL; mg/mL 59062-1219_29d79097-4097-4a90-8797-763ce3108532 59062-1219 HUMAN OTC DRUG BABYGANICS DIAPER RASH ZINC OXIDE CREAM TOPICAL 20130621 OTC MONOGRAPH FINAL part347 KAS Direct LLC dba BabyGanics ZINC OXIDE 150 mg/g 59062-1227_931af0f3-f269-41a1-8f3a-7d0b06049838 59062-1227 HUMAN OTC DRUG BabyGanics Sunscreen 30SPF TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20130621 OTC MONOGRAPH NOT FINAL part352 KAS Direct LLC dba BabyGanics TITANIUM DIOXIDE; ZINC OXIDE 30; 30 mg/mL; mg/mL 59062-1229_f2eba61e-c8c3-42e7-86e1-da26bc7988e5 59062-1229 HUMAN OTC DRUG BabyGanics Sunscreen 30 SPF ZINC OXIDE, OCTINOXATE, and OCTISALATE SPRAY TOPICAL 20130621 OTC MONOGRAPH NOT FINAL part352 KAS Direct LLC dba BabyGanics OCTINOXATE; OCTISALATE; ZINC OXIDE 50; 40; 112 mg/mL; mg/mL; mg/mL 59062-1238_c18c9c98-c2d0-40ef-918c-e1a7d8bcce49 59062-1238 HUMAN OTC DRUG BabyGanics Sunscreen 50SPF OCTINOXATE, OCTISALATE, and ZINC OXIDE LOTION TOPICAL 20130621 OTC MONOGRAPH NOT FINAL part352 KAS Direct LLC dba BabyGanics OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 50; 117 mg/mL; mg/mL; mg/mL 59062-1247_9089e657-1791-4973-bc50-5db678400ee9 59062-1247 HUMAN OTC DRUG BabyGanics Sunscreen 50SPF OCTINOXATE, OCTISALATE, and ZINC OXIDE LOTION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 KAS Direct LLC dba BabyGanics OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 50; 117 mg/mL; mg/mL; mg/mL 59062-1286_a0785182-cd80-40a7-93b2-86fb39577fc3 59062-1286 HUMAN OTC DRUG BabyGanics Cold Relief Chest Rub MENTHOL STICK TOPICAL 20130815 OTC MONOGRAPH FINAL part341 KAS Direct LLC dba BabyGanics MENTHOL 2.6 mg/g 59062-1303_12de681d-9919-4bee-ad1d-acf4186f72bd 59062-1303 HUMAN OTC DRUG BABYGANICS ECZEMA OATMEAL LOTION TOPICAL 20130621 OTC MONOGRAPH FINAL part347 KAS Direct LLC dba BabyGanics OATMEAL 10 mg/g 59062-1304_6a93b92d-6eeb-4bad-bc16-dcdb81c26fc4 59062-1304 HUMAN OTC DRUG BabyGanics Bye, Bye Dry Eczema OATMEAL LOTION TOPICAL 20130621 OTC MONOGRAPH FINAL part347 KAS Direct LLC dba BabyGanics OATMEAL 10 mg/g 59062-1327_1b8377dc-bdf4-4c7f-b222-61baac583868 59062-1327 HUMAN OTC DRUG BabyGanics Alcohol Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333E KAS Direct LLC dba BabyGanics BENZALKONIUM CHLORIDE .1 mg/mL 59062-1381_3208240a-1faf-4c9f-97f7-8ca94652215f 59062-1381 HUMAN OTC DRUG BabyGanics Alcohol Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333E KAS Direct LLC dba BabyGanics BENZALKONIUM CHLORIDE .1 mg/mL 59063-127_ce4a0985-fac9-4688-9a48-0f2943bf6434 59063-127 HUMAN PRESCRIPTION DRUG Gabapentin gabapentin SOLUTION ORAL 20120501 ANDA ANDA076403 Kiel Laboratories, Inc. GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59067-001_bdf145b2-6dca-4b43-9196-2c4ab597504a 59067-001 HUMAN OTC DRUG Emesyl Nausea Relief Ipecacuanha, Tabacum, Zingiber officinale SPRAY NASAL 20140520 UNAPPROVED HOMEOPATHIC Itonis, Inc. GINGER; IPECAC; TOBACCO LEAF 1; 3; 3 [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL 59075-730_cf8ba887-c1ab-4293-aa7b-009d41b5ab29 59075-730 HUMAN PRESCRIPTION DRUG TYSABRI natalizumab INJECTION INTRAVENOUS 20041123 20160630 BLA BLA125104 Elan Pharmaceuticals, Inc. NATALIZUMAB 300 mg/15mL Integrin Receptor Antagonist [EPC],Integrin Receptor Antagonists [MoA] 59078-001_bc0da773-2816-4b40-a330-fd2358d156a6 59078-001 HUMAN OTC DRUG INTENSE CARE GALACTOMYCES WHITENING Titanium Dioxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE .38 mg/45mL 59078-002_8f928989-9c0a-4058-85df-d24f7902e40f 59078-002 HUMAN OTC DRUG INTENSE CARE GALACTOMYCES WHITENING ESSENCE Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 11.57 mg/50mL 59078-003_cff39e8b-0dd4-4a8f-b12c-6c6d2bb4ec2e 59078-003 HUMAN OTC DRUG INTENSE CARE GALACTOMYCES FIRST ESSENCE Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 31 mg/155mL 59078-004_26651a06-a9d8-48c7-af3e-0c88f560470b 59078-004 HUMAN OTC DRUG G9 Whitening Skin ZINC OXIDE LIQUID TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. ZINC OXIDE .65 mg/130mL 59078-005_667eed57-4c82-462c-af81-4a3e09becba6 59078-005 HUMAN OTC DRUG G9 Whitening DIMETHICONE LOTION TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE 2.4 mg/130mL 59078-006_6a35be34-29f6-4cc2-a98d-9fe384484b64 59078-006 HUMAN OTC DRUG FLORIA WHITENING PETAL TONER Dimethicone LIQUID TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE 3.1 mg/155mL 59078-007_4443c385-93bc-4f5a-85af-bbf6b120626e 59078-007 HUMAN OTC DRUG FLORIA WHITENING DAY SPF15 PA Plus OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 3.5; 1.28 mg/50mL; mg/50mL 59078-008_556f890c-2999-4f03-9d57-a7f57ed612d8 59078-008 HUMAN OTC DRUG FLORIA WHITENING EMULSION Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 26 mg/130mL 59078-009_01a3c85e-cbc3-45f8-9028-d72a9764080c 59078-009 HUMAN OTC DRUG GALACTOMYCES MAN BOOSTER Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 29 mg/145mL 59078-010_4d8d37cd-03e8-41d6-a889-c8ae91522e2d 59078-010 HUMAN OTC DRUG Intense Care Snail Skin Glycerin LIQUID TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 28 mg/140mL 59078-011_055dbfbb-8b29-4a0d-9439-b837fc81f2a3 59078-011 HUMAN OTC DRUG Intense Care Snail Essence Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 7 mg/35mL 59078-012_b43cfdd9-2537-4f16-96f8-d7683ecf39d7 59078-012 HUMAN OTC DRUG Intense Care Snail Anti wrinkle Whitening Nutrition Glycerin LOTION TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 28 mg/140mL 59078-013_a8691c5f-6225-488d-bec6-f221475506e5 59078-013 HUMAN OTC DRUG Intense Care Snail Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 9 mg/45mL 59078-014_26d23e07-2a67-4d17-ad22-dd61c930e19f 59078-014 HUMAN OTC DRUG Intense Care Snail Eye Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 5 mg/25mL 59078-015_f6be680e-c96d-4848-9270-6ea9e2c02a89 59078-015 HUMAN OTC DRUG Intense Care Snail ampoule Glycerin LIQUID TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN .8 mg/81 59078-016_edb20950-ccf8-4a4c-901d-e74bea567944 59078-016 HUMAN OTC DRUG Intense Care Snail Hydro Gel Mask Glycerin PATCH TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 5 g/25g 59078-017_01c811fa-fc51-4841-b7a6-555a32be5a2e 59078-017 HUMAN OTC DRUG The Oriental Gyeol Goun Two Way Pact Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; 2.33; .59 g/20g; g/20g; g/20g 59078-018_eec4a706-68ac-4282-b018-32549c961da4 59078-018 HUMAN OTC DRUG G9 Moisture CC SPF30 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 1; 3.36; .96 g/50g; g/50g; g/50g; g/50g 59078-019_3e0974d9-b70e-4fca-bcdb-4a68abfcce6e 59078-019 HUMAN OTC DRUG Timeless EGF Power Toner Glycerin LIQUID TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 28 mg/140mL 59078-020_ecd3c09e-07b7-4cdc-9388-3e6d8166614a 59078-020 HUMAN OTC DRUG Timeless EGF Power Essence Dimethicone CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE 7 mg/35mL 59078-021_5c8e1d63-9d18-4855-8350-55bbab053d61 59078-021 HUMAN OTC DRUG Timeless EGF Power Emulsion Dimethicone CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE 1.4 mg/140mL 59078-022_185a9e61-9ff0-4717-9ca2-e746562493e5 59078-022 HUMAN OTC DRUG Timeless EGF Power Dimethicone CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE 1.5 mg/50mL 59078-023_5bc159bb-5132-4928-904a-663f4740da17 59078-023 HUMAN OTC DRUG Timeless EGF Power Eye Dimethicone CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE .6 mg/30mL 59078-024_fa4c0881-feb4-4d2a-827e-838e70a2cfc9 59078-024 HUMAN OTC DRUG Timeless Placenta Bound GLYCERIN, DIMETHICONE CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE; GLYCERIN 1.5; 15 mg/50mL; mg/50mL 59078-025_8ec24db6-48a8-4278-88e6-dcc6164afd3d 59078-025 HUMAN OTC DRUG Timeless Placenta Hydrogel Mask Titanium Dioxide PATCH TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE .001 g/30g 59078-026_1f3f124e-fd70-445e-90e6-2b5253879f86 59078-026 HUMAN OTC DRUG Luminous AuraCapsule CC Titanium Dioxide, OCTINOXATE, OCTISALATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 3.75; 2.5; 4.09; 2.45 mg/50mL; mg/50mL; mg/50mL; mg/50mL 59078-027_d6721586-5cd5-49ab-8f05-fd33dce063f6 59078-027 HUMAN OTC DRUG Luminous Pure Aura CC Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.5; 2.6; 2.45 mg/50mL; mg/50mL; mg/50mL 59078-028_b5eb62ca-1c4a-4e63-a660-1cfc6c37e534 59078-028 HUMAN OTC DRUG Luminous Live Aura CC Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.5; 3.61; 2.45 mg/50mL; mg/50mL; mg/50mL 59078-029_dd51fb89-b616-4727-83c5-2badc9825954 59078-029 HUMAN OTC DRUG Luminous Bright Aura CC OCTINOXATE, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.01; .88 mg/30mL; mg/30mL; mg/30mL 59078-030_742d79c5-f721-4f6a-a100-1df8231017ff 59078-030 HUMAN OTC DRUG Luminous Goddess Aura Live Melting Foundation Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; 2.54; .88 g/18g; g/18g; g/18g 59078-031_5d913f88-d6f7-424c-b147-229b3e29e0f8 59078-031 HUMAN OTC DRUG BB fit Perfect 24 BB 01 Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 6.21; .96 g/50g; g/50g; g/50g 59078-032_c8db48dc-f94f-4d25-97d8-f08415ba2246 59078-032 HUMAN OTC DRUG BB fit Perfect 24 BB 02 Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 6.21; .96 g/50g; g/50g; g/50g 59078-033_5e51ad66-9742-49be-a53f-72409d6ce170 59078-033 HUMAN OTC DRUG BB fit Sheer BB Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 4.09; .96 g/50g; g/50g; g/50g 59078-034_79837446-1556-46bc-be6c-0f68ef71d5da 59078-034 HUMAN OTC DRUG Tomatox Magic Massage Pack Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 24 g/80g 59078-035_8dea0867-c09e-4c66-bc18-08b46d94431f 59078-035 HUMAN OTC DRUG Face Mix Make up Base Green OCTINOXATE, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1; .88 g/30g; g/30g; g/30g 59078-036_e9b9fa32-1342-42ec-a006-ccef039d1ddf 59078-036 HUMAN OTC DRUG Tangerin Whitening Hand Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 6 g/30g 59078-037_0e14a326-5593-44a0-83c8-aa703d02127e 59078-037 HUMAN OTC DRUG UV SUNSET Body And Family Sun OCTINOXATE, OCTISALATE, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 2.9; 4.9 mg/100mL; mg/100mL; mg/100mL; mg/100mL 59078-038_f379298a-6349-4a99-b33c-b2fccf694a1d 59078-038 HUMAN OTC DRUG Mini Berry Lip Balm Blueberry OCTINOXATE, Titanium Dioxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .36; .01 g/7.2g; g/7.2g 59078-039_61de4f1f-7d13-4b43-b19c-8d0a150a978e 59078-039 HUMAN OTC DRUG Face Mix Skin Foundation Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; 2.83; .29 g/30g; g/30g; g/30g 59078-040_e35348f1-1437-403e-919e-60727e7e42d5 59078-040 HUMAN OTC DRUG Aqua Aura Moist Finish Pact TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE .97; .1 g/10g; g/10g 59078-041_8decda20-c938-45f1-8c86-d1b706e058a5 59078-041 HUMAN OTC DRUG UV SUNSET Waterproof Sun Block ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.1; 8.06 g/60g; g/60g 59078-042_3ac2d36a-5809-474f-ab1b-cc876a93595b 59078-042 HUMAN OTC DRUG Luminous Goddess Aura BB Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.15; 4.47; 1.32 g/45g; g/45g; g/45g 59078-043_08ea0a64-44f1-4838-80fa-0b9bfc5e665e 59078-043 HUMAN OTC DRUG Mini Berry Lip Balm Cherry OCTINOXATE, Titanium Dioxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .36; .06 g/7.2g; g/7.2g 59078-044_ef7028b7-d70e-4647-b2d4-5e8ef5ef3334 59078-044 HUMAN OTC DRUG Prestige Snail Lip Treatment OCTINOXATE, OCTISALATE STICK TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; OCTISALATE .24; .14 g/3.5g; g/3.5g 59078-045_125afb33-ecb3-4464-acb2-76a756ea3002 59078-045 HUMAN OTC DRUG TONYMOLY INTENSE CARE GOLD 24K SNAIL Dimethicone CREAM TOPICAL 20140501 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE .45 mg/45mL 59078-046_53cc4347-b0da-4dfb-b9ed-e13dd2846ff5 59078-046 HUMAN OTC DRUG TONYMOLY KISS KISS LIP ESSENCE BALM OCTINOXATE CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE .36 g/7.2g 59078-047_286c1ce5-394b-4d36-acdb-83f69225948a 59078-047 HUMAN OTC DRUG TONYMOLY My Sunny Perfecting Sun Block OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 2; 4.25 mg/100mL; mg/100mL; mg/100mL 59078-048_a46e82ff-1372-4a35-89bc-0746eb389694 59078-048 HUMAN OTC DRUG TONYMOLY BCDATION 01 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 5.22; .72 g/50g; g/50g 59078-049_34f429da-538f-4cb8-a02e-8981f7ba2231 59078-049 HUMAN OTC DRUG TONYMOLY BCDATION 02 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 5.22; .72 g/50g; g/50g 59078-050_1cd271ac-1d7f-4ee5-8d30-3dca47d0ff12 59078-050 HUMAN OTC DRUG TONYMOLY FLORIA WHITENING ESSENCE Dimethicone CREAM TOPICAL 20140501 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE .5 mg/50mL 59086-085_ac72eb44-3edb-4119-8ffe-b2a482ab728d 59086-085 HUMAN OTC DRUG MY INSTANT HAND SANITIZER with aloe and vitamin e ETHYL ALCOHOL GEL TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part333E Mapco Express ALCOHOL 620 mg/mL 59088-104_abb6278b-7f67-454d-bc45-70b2feed4289 59088-104 HUMAN PRESCRIPTION DRUG Fluoride Sodium Fluoride TABLET, CHEWABLE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation SODIUM FLUORIDE .25 mg/1 59088-105_db77bcae-d6c7-4ce8-b63d-1f6ad0b8b7bc 59088-105 HUMAN PRESCRIPTION DRUG Fluoride Sodium Fluoride TABLET, CHEWABLE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation SODIUM FLUORIDE .5 mg/1 59088-106_4ff12dfe-6416-438a-955d-fb7fe0515e53 59088-106 HUMAN PRESCRIPTION DRUG Fluoride Sodium Fluoride TABLET, CHEWABLE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation SODIUM FLUORIDE 1 mg/1 59088-107_314c4eba-6a4e-480c-b6da-ae849c15ce07 59088-107 HUMAN PRESCRIPTION DRUG Multivitamin with Fluoride Sodium Fluoride TABLET, CHEWABLE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A 15; 24; 400; 4.5; 300; 13.5; 1.05; 1.2; 36; .25; 1.05; 2500 [iU]/1; mg/1; [iU]/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 59088-108_5fe40b56-0d4b-4ce7-b7b4-762ea4f3115f 59088-108 HUMAN PRESCRIPTION DRUG Multivitamin with Fluoride Sodium Fluoride TABLET, CHEWABLE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A 15; 24; 400; 4.5; 300; 13.5; 1.05; 1.2; 36; .5; 1.05; 2500 [iU]/1; mg/1; [iU]/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 59088-109_a13bdc11-846e-49fe-9196-4c0e8c04ca18 59088-109 HUMAN PRESCRIPTION DRUG Multivitamin with Fluoride Sodium Fluoride TABLET, CHEWABLE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A 15; 24; 400; 4.5; 300; 13.5; 1.05; 1.2; 36; 1; 1.05; 2500 [iU]/1; mg/1; [iU]/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 59088-112_4d17e61e-bc2a-42ca-a019-4f3801ba2108 59088-112 HUMAN PRESCRIPTION DRUG PureVit DualFe Plus Ferrous Fumarate, Polysaccharide Iron Complex CAPSULE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation CALCIUM PANTOTHENATE; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; IRON DEXTRAN; MANGANESE SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE 10; .8; 15; 53; 1; 53; 1.3; 30; 5; 6; 200; 10; 18.2 mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 59088-113_513d5b5f-1f99-42b6-8256-7c9de4b8d1a9 59088-113 HUMAN PRESCRIPTION DRUG PureFe OB Plus Ferrous Fumarate and Polysaccharide Iron Complex CAPSULE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation CALCIUM PANTOTHENATE; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; IRON DEXTRAN; MAGNESIUM SULFATE, UNSPECIFIED; MANGANESE SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE 10; .8; 15; 53; 1; 53; 6.9; 1.3; 30; 5; 6; 200; 10; 18.2 mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 59088-114_d726c3d0-9d1f-43ea-8971-30ecba0e87b7 59088-114 HUMAN PRESCRIPTION DRUG PureFe Plus Ferrous Fumarate CAPSULE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation CALCIUM PANTOTHENATE; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM SULFATE, UNSPECIFIED; MANGANESE SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE 10; .8; 15; 106; 1; 6.9; 1.3; 30; 5; 6; 200; 10; 18.2 mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 59088-115_74e6eada-1f23-4201-90ad-d2756e14820a 59088-115 HUMAN PRESCRIPTION DRUG PNV OB DHA Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium, Docosahexaenoic Acid (DHA) KIT 20110601 UNAPPROVED DRUG OTHER PureTek Corporation 59088-120_3fe54497-e71b-43d8-bb09-ef4b62541e14 59088-120 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20110707 OTC MONOGRAPH FINAL part343 PureTek Corporation ASPIRIN 325 mg/1 59088-543_cc97b2a3-19d0-4e18-a410-1df167aa70e4 59088-543 HUMAN OTC DRUG GenRx All Purpose Cleansing Benzalkonium Chloride SPRAY TOPICAL 20130108 OTC MONOGRAPH NOT FINAL part333E PureTek Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL 59088-644_1158f1d3-d33f-4f63-9323-e35237962fcb 59088-644 HUMAN OTC DRUG GenRx All Purpose Cleansing Dimethicone LOTION TOPICAL 20130108 OTC MONOGRAPH FINAL part347 PureTek Corporation DIMETHICONE 17.5 mg/mL 59088-663_006f721b-ed15-4642-b6ee-2bd870d60538 59088-663 HUMAN OTC DRUG GenRx Ultra Therapeutic Skin Repairing Dimethicone CREAM TOPICAL 20130108 OTC MONOGRAPH FINAL part347 PureTek Corporation DIMETHICONE 50 mg/mL 59088-737_653db302-c39a-47cd-9a1f-575eb5f4965d 59088-737 HUMAN OTC DRUG Dermalogica Oil Control Salicylic Acid LOTION TOPICAL 20031117 OTC MONOGRAPH FINAL part333D PureTek Corporation SALICYLIC ACID 10 uL/mL 59088-740_63030485-b4fb-4759-ba7a-3e94fbe8fcdb 59088-740 HUMAN OTC DRUG Body Essence Raspberry Antibacterial Triclosan LOTION TOPICAL 20091228 OTC MONOGRAPH NOT FINAL part333A PureTek Corporation TRICLOSAN 1.7 uL/mL 59088-746_8f117e1c-6634-4c23-88eb-f13592490b93 59088-746 HUMAN OTC DRUG GenRx Daily Defense Antifungal Miconazole Nitrate CREAM TOPICAL 20130108 OTC MONOGRAPH FINAL part333C PureTek Corporation MICONAZOLE NITRATE 20 mg/mL 59088-771_11797eb7-f6f4-4b78-a6f9-4f35104ca537 59088-771 HUMAN PRESCRIPTION DRUG Lidocaine HCl - Hydrocortisone Acetate Lidocaine HCl and Hydrocortisone Acetate CREAM RECTAL 20110701 UNAPPROVED DRUG OTHER PureTek Corporation HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE 10; 30 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59088-816_a504c83a-356b-4c73-843e-1f95e4bbe8ca 59088-816 HUMAN PRESCRIPTION DRUG Lidocaine HCl - Hydrocortisone Acetate Lidocaine HCl and Hydrocortisone Acetate CREAM RECTAL 20110701 UNAPPROVED DRUG OTHER PureTek Corporation HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE 20; 20 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59088-817_e97e7fef-59af-43c7-b92e-246f62239527 59088-817 HUMAN PRESCRIPTION DRUG Lidocaine HCl - Hydrocortisone Acetate with Aloe Lidocaine HCl and Hydrocortisone Acetate GEL RECTAL 20110701 UNAPPROVED DRUG OTHER PureTek Corporation HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE 5.5; 28 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59088-819_c7a26097-7b99-4ede-9db0-be4501344fcf 59088-819 HUMAN PRESCRIPTION DRUG Lidocaine HCl - Hydrocortisone Acetate Lidocaine HCl and Hydrocortisone Acetate CREAM RECTAL; TOPICAL 20110701 UNAPPROVED DRUG OTHER PureTek Corporation HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE 5; 30 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59088-829_a86e83e1-1d8a-41a2-a452-aa3e5635a04c 59088-829 HUMAN OTC DRUG GenRx Daily Defense Skin Repairing Dimethicone CREAM TOPICAL 20130108 OTC MONOGRAPH FINAL part347 PureTek Corporation DIMETHICONE 17.5 mg/mL 59088-838_ea673c0d-a8a4-419b-84d7-bf77f20753f5 59088-838 HUMAN PRESCRIPTION DRUG Lidocaine HCl - Hydrocortisone Acetate Lidocaine HCl and Hydrocortisone Acetate GEL RECTAL 20110622 UNAPPROVED DRUG OTHER PureTek Corporation HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE 25; 30 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59088-851_b0b80ff7-70de-4525-88e3-8f2a780999c6 59088-851 HUMAN OTC DRUG GenRx Skin Barrier Dimethicone CREAM TOPICAL 20130108 OTC MONOGRAPH FINAL part347 PureTek Corporation DIMETHICONE 15 mg/mL 59088-852_ca3e9b75-b2cb-47c7-8a57-af14be93351d 59088-852 HUMAN OTC DRUG GenRx Cala Zinc Skin Healing Zinc Oxide PASTE TOPICAL 20130108 OTC MONOGRAPH FINAL part347 PureTek Corporation ZINC OXIDE 200 mg/mL 59088-856_b03f7a42-b355-4aaa-934c-0c077e325a44 59088-856 HUMAN OTC DRUG Dynamic Skin Recovery SPF30 Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20090301 OTC MONOGRAPH NOT FINAL part352 PureTek Corporation AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 5; 5 uL/mL; uL/mL; uL/mL; uL/mL 59088-864_3f83b750-9ee9-415e-86a7-c9c3a81b59a9 59088-864 HUMAN PRESCRIPTION DRUG Otic Care Antipyrine and Benzocaine Antipyrine, Benzocaine SOLUTION TOPICAL 20110610 UNAPPROVED DRUG OTHER PureTek Corporation ANTIPYRINE; BENZOCAINE 54; 14 uL/mL; uL/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 59088-924_177cae4b-4ef0-413a-9096-0541d3991678 59088-924 HUMAN OTC DRUG GenRx Daily Defense Antifungal Miconazole Nitrate POWDER TOPICAL 20130108 OTC MONOGRAPH FINAL part333C PureTek Corporation MICONAZOLE NITRATE 20 mg/g 59088-942_9b7bf211-ba2b-4eb9-90aa-424cb523302f 59088-942 HUMAN OTC DRUG Dermectin Sunscreen Broad Spectrum SPF 30 Titanium Dioxide CREAM TOPICAL 20110712 OTC MONOGRAPH NOT FINAL part352 PureTek Corporation TITANIUM DIOXIDE 71 uL/mL 59088-954_eb085e50-92cd-4c95-ac02-f4985d896af7 59088-954 HUMAN OTC DRUG MyoRx Low Dose Pain Relieving Menthol CREAM TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part348 PureTek Corporation MENTHOL 5 uL/mL 59088-962_c0c8f8ac-76e9-4b8f-ac80-204b4fe8c576 59088-962 HUMAN OTC DRUG MyoRx Pain Relieving Menthol CREAM TOPICAL 20100128 OTC MONOGRAPH NOT FINAL part348 PureTek Corporation MENTHOL 20 uL/mL 59088-997_80faac90-35cc-4535-b11e-475f41b7dccf 59088-997 HUMAN PRESCRIPTION DRUG Lidocaine HCl Lidocaine HCl CREAM TOPICAL 20110613 UNAPPROVED DRUG OTHER PureTek Corporation LIDOCAINE HYDROCHLORIDE 30 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 59091-1001_f467ba90-7c3e-41b2-99db-06133a005223 59091-1001 HUMAN OTC DRUG Red Cleo POMEGRANATE LIQUID ORAL 20130702 UNAPPROVED DRUG OTHER Health-Love Co. POMEGRANATE 1 mg/mL 59091-2001_4fe9a8f4-f143-4636-aeb2-09dcbd23cd7f 59091-2001 HUMAN OTC DRUG Dr. Super Khan MILK THISTLE CAPSULE ORAL 20130705 UNAPPROVED DRUG OTHER Health-Love Co. MILK THISTLE 260 mg/1 59092-001_b784f5ff-a1e0-40d4-8367-51936a7b8c66 59092-001 HUMAN OTC DRUG Arthritis Pain Reliever capsaicin CREAM TOPICAL 20140119 OTC MONOGRAPH NOT FINAL part348 HPI Health Products Inc. CAPSAICIN .25 mg/mL 59092-002_d2e78b92-e128-4286-bee9-a3b458ca5f6a 59092-002 HUMAN OTC DRUG Extra Strength Pain Reliever capsaicin and menthol, unspecified form CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part348 HPI Health Products Inc. CAPSAICIN; MENTHOL, UNSPECIFIED FORM .35; 30 mg/mL; mg/mL 59105-001_28039dee-1083-4f3f-9b0e-fb110e100008 59105-001 HUMAN OTC DRUG ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130820 OTC MONOGRAPH NOT FINAL part343 J.P. BUSINESS ENTERPRISE ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 59105-002_ab71fcc6-f102-4f69-9260-6502790cf34e 59105-002 HUMAN OTC DRUG IBUPROFEN IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20130820 ANDA ANDA079205 J.P BUSINESS ENTERPRISE IBUPROFEN 200 mg/1 59105-003_903b78b4-e647-481e-8c57-aeb1cef51804 59105-003 HUMAN OTC DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130820 ANDA ANDA090545 J.P. BUSINESS ENTERPRISE NAPROXEN SODIUM 220 mg/1 59105-004_f5c29029-dfaa-4d46-a2ac-72da0befb060 59105-004 HUMAN OTC DRUG ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE and PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20141201 OTC MONOGRAPH NOT FINAL part343 J.P. BUSINESS ENTERPRISE ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 59105-005_15792cd7-318f-4cd8-8d58-af5900946a01 59105-005 HUMAN OTC DRUG ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE and DOXYLAMINE SUCCINATE ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20141201 OTC MONOGRAPH NOT FINAL part343 J.P. BUSINESS ENTERPRISE ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 59105-006_eaa9c7f8-90c1-45fa-8d2b-d528ba80cdcb 59105-006 HUMAN OTC DRUG DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20141201 OTC MONOGRAPH FINAL part341 J.P. BUSINESS ENTERPRISE DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 59105-007_4f7c90bc-6e4c-4918-8243-7621c910e051 59105-007 HUMAN OTC DRUG DOCUSATE SODIUM DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20141201 OTC MONOGRAPH NOT FINAL part334 J.P. BUSINESS ENTERPRISE DOCUSATE SODIUM 100 mg/1 59110-517_f166ba6a-4d24-4a37-867e-db9023af35be 59110-517 HUMAN OTC DRUG CONTROL CHLOROXYLENOL SOAP TOPICAL 20140123 OTC MONOGRAPH NOT FINAL part333E Standardized Sanitation Systems CHLOROXYLENOL 2.5 g/1000mL 59115-002_30bc5631-2129-45c4-a2bb-fc65bcbe9fe5 59115-002 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 19980218 ANDA ANDA074480 Hikma Pharmaceutical NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 59115-023_cdef2682-e8be-4ecc-af87-6cc311225302 59115-023 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20050125 ANDA ANDA065191 Hikma Pharmaceutical AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 59115-024_cdef2682-e8be-4ecc-af87-6cc311225302 59115-024 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20050125 ANDA ANDA065191 Hikma Pharmaceutical AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 59115-028_a5a5af08-2567-4696-965c-fa2e478cc0b6 59115-028 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Hikma Pharmaceutical CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 59115-029_a5a5af08-2567-4696-965c-fa2e478cc0b6 59115-029 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Hikma Pharmaceutical CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 59115-030_a5a5af08-2567-4696-965c-fa2e478cc0b6 59115-030 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Hikma Pharmaceutical CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 59115-040_c0157442-903b-49a0-a3fc-b8ca73711170 59115-040 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20060329 ANDA ANDA065255 Hikma Pharmaceutical AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 59115-041_369d1ebb-20b3-4b20-a3f5-1ee504b643af 59115-041 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20070205 ANDA ANDA065291 Hikma Pharmaceutical AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 59115-042_369d1ebb-20b3-4b20-a3f5-1ee504b643af 59115-042 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20070205 ANDA ANDA065291 Hikma Pharmaceutical AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 59115-043_43603a64-325c-4c5a-b7c4-4b06d15b8c9b 59115-043 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 Hikma Pharmaceutical AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 59115-044_43603a64-325c-4c5a-b7c4-4b06d15b8c9b 59115-044 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 Hikma Pharmaceutical AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 59115-045_43603a64-325c-4c5a-b7c4-4b06d15b8c9b 59115-045 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 Hikma Pharmaceutical AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 59115-046_43603a64-325c-4c5a-b7c4-4b06d15b8c9b 59115-046 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 Hikma Pharmaceutical AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 59115-047_08911bd9-dcaf-46bf-82a4-98484cea2358 59115-047 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20071001 ANDA ANDA077887 Hikma Pharmaceutical CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 59115-048_08911bd9-dcaf-46bf-82a4-98484cea2358 59115-048 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20071001 ANDA ANDA077887 Hikma Pharmaceutical CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 59115-049_08911bd9-dcaf-46bf-82a4-98484cea2358 59115-049 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20071001 ANDA ANDA077887 Hikma Pharmaceutical CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 59115-050_08911bd9-dcaf-46bf-82a4-98484cea2358 59115-050 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20071001 ANDA ANDA077887 Hikma Pharmaceutical CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 59115-053_4b279cda-394a-40d3-9cd9-dd8c66d0ce4b 59115-053 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090810 ANDA ANDA077864 Hikma Pharmaceutical SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59115-054_4b279cda-394a-40d3-9cd9-dd8c66d0ce4b 59115-054 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090810 ANDA ANDA077864 Hikma Pharmaceutical SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59115-055_4b279cda-394a-40d3-9cd9-dd8c66d0ce4b 59115-055 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090810 ANDA ANDA077864 Hikma Pharmaceutical SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59115-056_1e1780ca-5513-49a7-9ee3-f27be5b2ccce 59115-056 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20110412 ANDA ANDA077771 Hikma Pharmaceutical AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 59115-057_1e1780ca-5513-49a7-9ee3-f27be5b2ccce 59115-057 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20110412 ANDA ANDA077771 Hikma Pharmaceutical AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 59115-058_1e1780ca-5513-49a7-9ee3-f27be5b2ccce 59115-058 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20110412 ANDA ANDA077771 Hikma Pharmaceutical AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 59115-061_50d351a9-b260-4a68-bb21-1bdf4b0b0098 59115-061 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20071109 ANDA ANDA065373 Hikma Pharmaceutical AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 59115-065_5a7d93d6-4858-4ef3-afe7-ea016442df5f 59115-065 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110419 ANDA ANDA078134 Hikma Pharmaceutical LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 59115-066_5a7d93d6-4858-4ef3-afe7-ea016442df5f 59115-066 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110419 ANDA ANDA078134 Hikma Pharmaceutical LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 59115-067_5a7d93d6-4858-4ef3-afe7-ea016442df5f 59115-067 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110419 ANDA ANDA078134 Hikma Pharmaceutical LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 59115-068_5a7d93d6-4858-4ef3-afe7-ea016442df5f 59115-068 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110419 ANDA ANDA078134 Hikma Pharmaceutical LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 59115-069_67cd82f2-e6a0-4db1-8c35-0f5524bc1712 59115-069 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20080404 ANDA ANDA090543 Hikma Pharmaceutical MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 59115-070_67cd82f2-e6a0-4db1-8c35-0f5524bc1712 59115-070 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20080404 ANDA ANDA090543 Hikma Pharmaceutical MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 59115-073_e4d350e8-da9f-41f6-be75-353e33ee8463 59115-073 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 Hikma Pharmaceutical GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59115-074_e4d350e8-da9f-41f6-be75-353e33ee8463 59115-074 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 Hikma Pharmaceutical GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59115-075_e4d350e8-da9f-41f6-be75-353e33ee8463 59115-075 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 Hikma Pharmaceutical GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59115-086_999b9e3d-ca69-462b-b4d0-2515933dedec 59115-086 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20110721 ANDA ANDA078782 Hikma Pharmaceutical GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59115-087_999b9e3d-ca69-462b-b4d0-2515933dedec 59115-087 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20110721 ANDA ANDA078782 Hikma Pharmaceutical GABAPENTIN 600 mg/1001 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59115-088_58f355ed-cb9c-4c8b-9e92-e38036d4d5d5 59115-088 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090601 ANDA ANDA078740 Hikma Pharmaceutical RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 59115-089_58f355ed-cb9c-4c8b-9e92-e38036d4d5d5 59115-089 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090601 ANDA ANDA078740 Hikma Pharmaceutical RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 59115-090_58f355ed-cb9c-4c8b-9e92-e38036d4d5d5 59115-090 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090601 ANDA ANDA078740 Hikma Pharmaceutical RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 59115-091_58f355ed-cb9c-4c8b-9e92-e38036d4d5d5 59115-091 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090601 ANDA ANDA078740 Hikma Pharmaceutical RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 59115-092_58f355ed-cb9c-4c8b-9e92-e38036d4d5d5 59115-092 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090601 ANDA ANDA078740 Hikma Pharmaceutical RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 59115-093_58f355ed-cb9c-4c8b-9e92-e38036d4d5d5 59115-093 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090601 ANDA ANDA078740 Hikma Pharmaceutical RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 59115-094_b12e5223-390a-46b2-a29b-bbc6a704080a 59115-094 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20100816 ANDA ANDA078599 Hikma Pharmaceutical GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 59115-095_9efe5654-c187-4c9a-a702-2317f5600b6d 59115-095 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110621 ANDA ANDA078767 Hikma Pharmaceutical LEVOFLOXACIN 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 59115-096_9efe5654-c187-4c9a-a702-2317f5600b6d 59115-096 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110621 ANDA ANDA078767 Hikma Pharmaceutical LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 59115-097_9efe5654-c187-4c9a-a702-2317f5600b6d 59115-097 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110621 ANDA ANDA078767 Hikma Pharmaceutical LEVOFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 59115-100_3b4a1c2f-5dcc-4530-9243-86657c940c0b 59115-100 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 Hikma Pharmaceutical ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59115-101_3b4a1c2f-5dcc-4530-9243-86657c940c0b 59115-101 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 Hikma Pharmaceutical ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59115-102_3b4a1c2f-5dcc-4530-9243-86657c940c0b 59115-102 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 Hikma Pharmaceutical ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59115-109_cbcb547e-f9ad-498e-ab84-42b17796174e 59115-109 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090247 Hikma Pharmaceutical DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 59115-110_cbcb547e-f9ad-498e-ab84-42b17796174e 59115-110 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090247 Hikma Pharmaceutical DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 59115-122_479115c6-bb13-4266-ba6a-be4f58657c86 59115-122 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Capsules Doxycycline Hyclate CAPSULE ORAL 19900901 ANDA ANDA062396 Hikma Pharmaceutical DOXYCYCLINE HYCLATE 100 mg/1 59115-123_479115c6-bb13-4266-ba6a-be4f58657c86 59115-123 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Capsules Doxycycline Hyclate CAPSULE ORAL 19900901 ANDA ANDA062396 Hikma Pharmaceutical DOXYCYCLINE HYCLATE 50 mg/1 59115-124_9ce8dab4-41eb-4ec6-98d8-29c86c7a343c 59115-124 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20131202 ANDA ANDA091185 Hikma Pharmaceutical TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59115-125_9ce8dab4-41eb-4ec6-98d8-29c86c7a343c 59115-125 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20131202 ANDA ANDA091185 Hikma Pharmaceutical TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59115-126_9ce8dab4-41eb-4ec6-98d8-29c86c7a343c 59115-126 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20131202 ANDA ANDA091185 Hikma Pharmaceutical TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59115-127_9ce8dab4-41eb-4ec6-98d8-29c86c7a343c 59115-127 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20131202 ANDA ANDA091185 Hikma Pharmaceutical TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59115-129_7bd8087a-3345-4959-8e53-588ea1782bda 59115-129 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086066 Hikma Pharmaceutical ISOSORBIDE DINITRATE 10 mg/1 59115-130_7bd8087a-3345-4959-8e53-588ea1782bda 59115-130 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 19830426 ANDA ANDA088088 Hikma Pharmaceutical ISOSORBIDE DINITRATE 20 mg/1 59115-135_31eb6bc4-6f4d-418b-a9f5-081f6140063e 59115-135 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20020627 ANDA ANDA076243 Hikma Pharmaceutical LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 59115-139_b911f5f3-484f-4103-84f4-c12158d9982b 59115-139 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19720522 ANDA ANDA080292 Hikma Pharmaceutical PREDNISONE 5 mg/1 59115-140_b911f5f3-484f-4103-84f4-c12158d9982b 59115-140 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19851204 ANDA ANDA088832 Hikma Pharmaceutical PREDNISONE 10 mg/1 59115-141_b911f5f3-484f-4103-84f4-c12158d9982b 59115-141 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19740226 ANDA ANDA083677 Hikma Pharmaceutical PREDNISONE 20 mg/1 59115-143_7bd8087a-3345-4959-8e53-588ea1782bda 59115-143 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086067 Hikma Pharmaceutical ISOSORBIDE DINITRATE 5 mg/1 59115-144_60b88d16-eb5e-4320-9fbb-036080321725 59115-144 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130822 ANDA ANDA076063 Hikma Pharmaceutical LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 59115-145_60b88d16-eb5e-4320-9fbb-036080321725 59115-145 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130822 ANDA ANDA076063 Hikma Pharmaceutical LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 59115-146_60b88d16-eb5e-4320-9fbb-036080321725 59115-146 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130822 ANDA ANDA076063 Hikma Pharmaceutical LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 59115-147_60b88d16-eb5e-4320-9fbb-036080321725 59115-147 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130822 ANDA ANDA076063 Hikma Pharmaceutical LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 59115-161_2f4560e1-52a1-4734-ad31-951d6135f8f3 59115-161 HUMAN PRESCRIPTION DRUG CORTISONE ACETATE CORTISONE ACETATE TABLET ORAL 20130826 ANDA ANDA080776 Hikma Pharmaceutical CORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59137-505_98e60f32-af64-4bb4-aeda-546f8472c21a 59137-505 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 7.5 mg/.15mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 59137-510_98e60f32-af64-4bb4-aeda-546f8472c21a 59137-510 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 10 mg/.2mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 59137-515_98e60f32-af64-4bb4-aeda-546f8472c21a 59137-515 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 12.5 mg/.25mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 59137-520_98e60f32-af64-4bb4-aeda-546f8472c21a 59137-520 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 15 mg/.3mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 59137-525_98e60f32-af64-4bb4-aeda-546f8472c21a 59137-525 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 17.5 mg/.35mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 59137-530_98e60f32-af64-4bb4-aeda-546f8472c21a 59137-530 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 20 mg/.4mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 59137-535_98e60f32-af64-4bb4-aeda-546f8472c21a 59137-535 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 22.5 mg/.45mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 59137-540_98e60f32-af64-4bb4-aeda-546f8472c21a 59137-540 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 25 mg/.5mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 59137-545_98e60f32-af64-4bb4-aeda-546f8472c21a 59137-545 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 27.5 mg/.55mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 59137-550_98e60f32-af64-4bb4-aeda-546f8472c21a 59137-550 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 30 mg/.6mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 59138-002_82644c85-d81e-4ba8-a00c-c73722f1bafa 59138-002 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19860101 UNAPPROVED MEDICAL GAS Gulf Medical Services, Inc. OXYGEN 99 L/100L 59139-0002_462a59fb-8975-4482-af90-7f2248ce0077 59139-0002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070921 UNAPPROVED MEDICAL GAS Grandview Hospital DBA Grandview Medical Company OXYGEN 99 L/100L 59148-002_87529ee8-61dd-420d-9868-67d49767a9ac 59148-002 HUMAN PRESCRIPTION DRUG PLETAL cilostazol TABLET ORAL 19990115 NDA NDA020863 Otsuka America Pharmaceutical, Inc. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 59148-003_87529ee8-61dd-420d-9868-67d49767a9ac 59148-003 HUMAN PRESCRIPTION DRUG PLETAL cilostazol TABLET ORAL 19990115 NDA NDA020863 Otsuka America Pharmaceutical, Inc. CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 59148-006_5177ecd6-6653-424d-8f1e-ce0ad3cd9a3b 59148-006 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] 59148-007_5177ecd6-6653-424d-8f1e-ce0ad3cd9a3b 59148-007 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] 59148-008_5177ecd6-6653-424d-8f1e-ce0ad3cd9a3b 59148-008 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] 59148-009_5177ecd6-6653-424d-8f1e-ce0ad3cd9a3b 59148-009 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] 59148-010_5177ecd6-6653-424d-8f1e-ce0ad3cd9a3b 59148-010 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] 59148-011_5177ecd6-6653-424d-8f1e-ce0ad3cd9a3b 59148-011 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] 59148-013_5177ecd6-6653-424d-8f1e-ce0ad3cd9a3b 59148-013 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE SOLUTION ORAL 20041210 NDA NDA021713 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 1 mg/mL Atypical Antipsychotic [EPC] 59148-016_5177ecd6-6653-424d-8f1e-ce0ad3cd9a3b 59148-016 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE INJECTION, SOLUTION INTRAMUSCULAR 20060920 NDA NDA021866 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 9.75 mg/1.3mL Atypical Antipsychotic [EPC] 59148-018_2299944f-0cc9-4be1-9aac-ae56dfc6434a 59148-018 HUMAN PRESCRIPTION DRUG ABILIFY MAINTENA aripiprazole KIT 20130228 NDA NDA202971 Otsuka America Pharmaceutical, Inc. 59148-019_2299944f-0cc9-4be1-9aac-ae56dfc6434a 59148-019 HUMAN PRESCRIPTION DRUG ABILIFY MAINTENA aripiprazole KIT 20130228 NDA NDA202971 Otsuka America Pharmaceutical, Inc. 59148-020_85d7ee95-e427-44d3-b535-4e40a58b9444 59148-020 HUMAN PRESCRIPTION DRUG SAMSCA tolvaptan TABLET ORAL 20090519 NDA NDA022275 Otsuka America Pharmaceutical Inc. TOLVAPTAN 15 mg/1 59148-021_85d7ee95-e427-44d3-b535-4e40a58b9444 59148-021 HUMAN PRESCRIPTION DRUG SAMSCA tolvaptan TABLET ORAL 20090519 NDA NDA022275 Otsuka America Pharmaceutical Inc. TOLVAPTAN 30 mg/1 59148-023_6e17a5e4-bc6a-418f-a09d-01b4f789b21e 59148-023 HUMAN PRESCRIPTION DRUG Pranactin-Citric UREA C-13 POWDER, FOR SOLUTION ORAL 20010510 NDA NDA020586 Otsuka America Pharmaceutical UREA C-13 75 mg/3000mg Carbon Radioisotopes [Chemical/Ingredient],Helicobacter pylori Diagnostic [EPC],Radioactive Tracers [Chemical/Ingredient],Urea [Chemical/Ingredient] 59148-045_2299944f-0cc9-4be1-9aac-ae56dfc6434a 59148-045 HUMAN PRESCRIPTION DRUG ABILIFY MAINTENA aripiprazole KIT 20141008 NDA NDA202971 Otsuka America Pharmaceutical, Inc. 59148-070_55352bb9-301a-454a-baa6-f0bb45e49e98 59148-070 HUMAN PRESCRIPTION DRUG BUSULFEX busulfan INJECTION INTRAVENOUS 19990204 NDA NDA020954 Otsuka America Pharmaceutical, Inc. BUSULFAN 6 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] 59148-072_2299944f-0cc9-4be1-9aac-ae56dfc6434a 59148-072 HUMAN PRESCRIPTION DRUG ABILIFY MAINTENA aripiprazole KIT 20141008 NDA NDA202971 Otsuka America Pharmaceutical, Inc. 59148-640_5177ecd6-6653-424d-8f1e-ce0ad3cd9a3b 59148-640 HUMAN PRESCRIPTION DRUG ABILIFY DISCMELT ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING ORAL 20060607 NDA NDA021729 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] 59148-641_5177ecd6-6653-424d-8f1e-ce0ad3cd9a3b 59148-641 HUMAN PRESCRIPTION DRUG ABILIFY DISCMELT ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING ORAL 20060607 NDA NDA021729 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] 59158-719_32388226-7797-4ea0-8d6f-f3aa9c1b3b70 59158-719 HUMAN OTC DRUG ALL YOU NEED CONTINUOUS ACTION 24 HOUR MOISTURE SPF 15 FOR NORMAL SKIN HOMOSALATE, OCTINOXATE, AVOBENZONE LOTION TOPICAL 20071201 OTC MONOGRAPH NOT FINAL part352 PRESCRIPTIVES INC. AVOBENZONE; HOMOSALATE; OCTINOXATE 3; 5; 5 mL/100mL; mL/100mL; mL/100mL 59158-723_2cbffe46-9175-45bd-9e7d-6a7f7c0b4157 59158-723 HUMAN OTC DRUG PRESCRIPTIVES ALL SKINS MINERAL MAKEUP 16 HR. SPF 10 TITANIUM DIOXIDE LIQUID TOPICAL 20090601 OTC MONOGRAPH NOT FINAL part352 PRESCRIPTIVES INC TITANIUM DIOXIDE 4.7 mL/100mL 59158-731_292b6d23-8e51-4a64-964c-cf1b49b45530 59158-731 HUMAN OTC DRUG TRACELESS SKIN RESPONSIVE TINT OCTINOXATE CREAM TOPICAL 20010601 OTC MONOGRAPH NOT FINAL part352 PRESCRIPTIVES INC. OCTINOXATE 2 mL/100mL 59158-759_67ae6048-66ac-4d96-b9dc-883948345126 59158-759 HUMAN OTC DRUG VIRTUAL SKIN SUPER NATURAL FINISH SPF 10 OCTINOXATE LIQUID TOPICAL 19990101 OTC MONOGRAPH NOT FINAL part352 PRESCRIPTIVES INC. OCTINOXATE 5.4 mL/100mL 59158-760_c74dfeac-224f-4b11-9a4d-39d4e386486d 59158-760 HUMAN OTC DRUG FLAWLESS SKIN MAKEUP BROAD SPECTRUM SPF 15 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20041222 OTC MONOGRAPH NOT FINAL part352 PRESCRIPTIVES INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .04551; .01554; .01665 g/mL; g/mL; g/mL 59158-913_32cbe570-53c5-4835-a17c-8cea24909895 59158-913 HUMAN OTC DRUG PRESCRIPTIVES SITE UNSEEN BRIGHTENING CONCEALER BROAD SPECTRUM SPF 15 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20061116 OTC MONOGRAPH NOT FINAL part352 PRESCRIPTIVES INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .04551; .01554; .01665 g/mL; g/mL; g/mL 59158-914_ec997f74-4a04-4f65-b9fa-dc00edba452d 59158-914 HUMAN OTC DRUG FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25 TITANIUM DIOXIDE PASTE TOPICAL 20051101 OTC MONOGRAPH NOT FINAL part352 PRESCRIPTIVES INC TITANIUM DIOXIDE 4.2 g/100g 59158-915_51a85dfa-3a72-43c4-8d2d-a01542b2999c 59158-915 HUMAN OTC DRUG VIRTUAL MATTE OIL CONTROL MAKEUP BROAD SPECTRUM SPF 15 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20030901 OTC MONOGRAPH NOT FINAL part352 PRESCRIPTIVES INC OCTINOXATE; TITANIUM DIOXIDE .02775; .010767 g/mL; g/mL 59194-001_a994ae6c-a94f-4a97-bfbf-d775e9fcdba2 59194-001 HUMAN OTC DRUG BANDAGE benzalkonium chloride SWAB TOPICAL 20130520 OTC MONOGRAPH NOT FINAL part333A Zhejiang Changdi Medical Co., Ltd. BENZALKONIUM CHLORIDE .0012 mg/mg 59194-002_7b237437-e77b-4d7e-a9d6-f1fd7764ca1f 59194-002 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20130702 OTC MONOGRAPH NOT FINAL part333A Zhejiang Changdi Medical Co., Ltd. ALCOHOL 70 mL/100mL 59212-422_ace53cd4-7294-4e47-8fb6-c75798b6a1ba 59212-422 HUMAN PRESCRIPTION DRUG Donnatal phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide ELIXIR ORAL 20091101 UNAPPROVED DRUG OTHER Concordia Pharmaceuticals Inc. ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 59212-423_ace53cd4-7294-4e47-8fb6-c75798b6a1ba 59212-423 HUMAN PRESCRIPTION DRUG Donnatal phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide ELIXIR ORAL 20091101 UNAPPROVED DRUG OTHER Concordia Pharmaceuticals Inc. ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 59212-425_664de240-32f2-4df1-a936-67414b751a96 59212-425 HUMAN PRESCRIPTION DRUG Donnatal PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE TABLET ORAL 20080507 UNAPPROVED DRUG OTHER Concordia Pharmaceuticals Inc. ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 59212-658_4abc7c3a-deae-4774-8f7e-a614da3ea24b 59212-658 HUMAN PRESCRIPTION DRUG Kapvay clonidine hydrochloride TABLET, EXTENDED RELEASE ORAL 20101209 NDA NDA022331 Concordia Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 59212-659_4abc7c3a-deae-4774-8f7e-a614da3ea24b 59212-659 HUMAN PRESCRIPTION DRUG Kapvay clonidine hydrochloride TABLET, EXTENDED RELEASE ORAL 20101209 NDA NDA022331 Concordia Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 59212-660_602771ef-9f4a-4302-9fb9-83119b262d24 59212-660 HUMAN PRESCRIPTION DRUG Clonidine hydrochloride extended-release clonidine hydrochloride TABLET, EXTENDED RELEASE ORAL 20101209 NDA NDA022331 Concordia Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 59212-700_cec0aa50-be6f-42f8-8a54-01cf81c44e9c 59212-700 HUMAN PRESCRIPTION DRUG Orapred ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING ORAL 20060601 NDA NDA021959 Concordia Pharmaceuticals Inc. PREDNISOLONE SODIUM PHOSPHATE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59212-701_cec0aa50-be6f-42f8-8a54-01cf81c44e9c 59212-701 HUMAN PRESCRIPTION DRUG Orapred ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING ORAL 20060601 NDA NDA021959 Concordia Pharmaceuticals Inc. PREDNISOLONE SODIUM PHOSPHATE 15 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59212-702_cec0aa50-be6f-42f8-8a54-01cf81c44e9c 59212-702 HUMAN PRESCRIPTION DRUG Orapred ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING ORAL 20060601 NDA NDA021959 Concordia Pharmaceuticals Inc. PREDNISOLONE SODIUM PHOSPHATE 30 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59212-780_83c434a7-b6aa-4966-8d33-3c1bf676632f 59212-780 HUMAN PRESCRIPTION DRUG Ulesfia benzyl alcohol LOTION TOPICAL 20090526 NDA NDA022129 Concordia Pharmaceuticals Inc. BENZYL ALCOHOL 50 mg/g Pediculicide [EPC] 59215-6143_1eeeff83-0ac6-4823-9e9e-474e7e65d69a 59215-6143 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Lewin Medical Supply OXYGEN 99 L/100L 59220-1001_1a9cb1a8-7647-4fcd-8251-48ff35a2184b 59220-1001 HUMAN OTC DRUG NMC Magma Mineral Pack MAGNESIUM PLASTER TOPICAL 20130708 UNAPPROVED DRUG OTHER NMC (Natural Magma Cosmetics) MAGNESIUM 3 g/100g 59220-2001_a4eb5207-f3c5-42cd-978d-6527f8b556bb 59220-2001 HUMAN OTC DRUG NMC Magic Serum ALLANTOIN LIQUID TOPICAL 20130708 UNAPPROVED DRUG OTHER NMC (Natural Magma Cosmetics) ALLANTOIN 1 mg/30mL 59220-3001_04e82b16-1c6e-45f8-b596-381e5dbcbea5 59220-3001 HUMAN OTC DRUG NMC Magic Serum ADENOSINE LIQUID TOPICAL 20130711 UNAPPROVED DRUG OTHER NMC (Natural Magma Cosmetics) ADENOSINE .04 mg/100mL 59220-4001_927d3dc1-d4f8-41c6-95fe-5fa83588fcff 59220-4001 HUMAN OTC DRUG NMC Staypot double programing cream ADENOSINE LIQUID TOPICAL 20130711 UNAPPROVED DRUG OTHER NMC (Natural Magma Cosmetics) ADENOSINE .04 mg/100mL 59225-0001_1ea1006c-a039-4309-a67a-a360a833dd12 59225-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130417 UNAPPROVED MEDICAL GAS Peachtree Medical OXYGEN 99 L/100L 59228-102_df7740d1-4c72-40ae-ab73-77fd3e3daa6e 59228-102 HUMAN OTC DRUG EAR CARE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part333A EMS Contract Packaging BENZALKONIUM CHLORIDE 1 g/1000mL 59228-103_946aca0d-8602-4fe7-a6ec-d09285a0c34b 59228-103 HUMAN OTC DRUG SINOFRESH NASAL AND SINUS CARE EUCALYPTUS GLOBULUS LEAF, POTASSIUM DICHROMATE LIQUID TOPICAL 20140530 UNAPPROVED HOMEOPATHIC EMS Contract Packaging EUCALYPTUS GLOBULUS LEAF; POTASSIUM DICHROMATE 20; 30 [hp_X]/100mL; [hp_X]/100mL 59229-001_6b558a45-e46b-44cf-9b54-a1525650b73f 59229-001 HUMAN OTC DRUG BANDAGE benzalkonium chloride SWAB TOPICAL 20130706 OTC MONOGRAPH NOT FINAL part333A YUYAO CHENGZE MEDICAL SUPPLIES FACTORY BENZALKONIUM CHLORIDE .0012 mg/mg 59229-002_2c8f6bc4-ef2f-4f1b-9664-ff7f88c5e2d9 59229-002 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20130731 OTC MONOGRAPH NOT FINAL part333A YUYAO CHENGZE MEDICAL SUPPLIES FACTORY ALCOHOL 70 mL/100mL 59229-003_459aaef0-3e56-4bfc-b4d8-52988c1a8a82 59229-003 HUMAN OTC DRUG BANDAGE benzalkonium chloride SWAB TOPICAL 20130706 OTC MONOGRAPH NOT FINAL part333A YUYAO CHENGZE MEDICAL SUPPLIES FACTORY BENZALKONIUM CHLORIDE .0012 mg/mg 59229-004_a24c3c9c-9103-4057-b488-fb08f728f747 59229-004 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20130805 OTC MONOGRAPH NOT FINAL part333A YUYAO CHENGZE MEDICAL SUPPLIES FACTORY ALCOHOL 70 mL/100mL 59229-005_7c841b44-ead6-4503-90f7-e6098ee3c2d9 59229-005 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20130805 OTC MONOGRAPH NOT FINAL part333A YUYAO CHENGZE MEDICAL SUPPLIES FACTORY ALCOHOL 70 mL/100mL 59240-001_6909f7f1-aff9-4bd6-83fc-d6acf4c8a0c0 59240-001 HUMAN OTC DRUG Medicated Body Powder menthol and zinc oxide POWDER TOPICAL 20130718 OTC MONOGRAPH FINAL part347 MAGVERZ INC MENTHOL; ZINC OXIDE .15; 1 g/100g; g/100g 59240-002_fa8835a8-5f7b-487f-bfc6-6d2740f1e412 59240-002 HUMAN OTC DRUG Cold and Hot Menthol SPRAY TOPICAL 20130718 OTC MONOGRAPH NOT FINAL part348 MAGVERZ INC MENTHOL 16 g/100mL 59240-003_23f2cb9b-3189-4389-a0b0-bfeb7c2ce53a 59240-003 HUMAN OTC DRUG Cold and Hot Menthol CREAM TOPICAL 20130718 OTC MONOGRAPH NOT FINAL part348 MAGVERZ INC MENTHOL .075 g/g 59243-100_e3cd2717-4e68-4fa1-9ca9-4d0aee15a933 59243-100 HUMAN OTC DRUG Septicare BENZETHONIUM CHLORIDE SOLUTION TOPICAL 19990626 OTC MONOGRAPH NOT FINAL part333A Sage Pharmaceuticals, Inc. BENZETHONIUM CHLORIDE 2 mg/mL 59243-110_bfc2c082-1a15-491d-84bd-a8ca08f00c68 59243-110 HUMAN OTC DRUG Perifoam BENZETHONIUM CHLORIDE SOLUTION TOPICAL 20001121 OTC MONOGRAPH NOT FINAL part333A Sage Pharmaceuticals, Inc. BENZETHONIUM CHLORIDE 2 mg/mL 59246-0001_f2cd1e05-f678-4d77-9d70-959f321e340f 59246-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130430 UNAPPROVED MEDICAL GAS A-Z HME Inc OXYGEN 99 L/100L 59248-001_16bd17e8-5b8b-4e06-b0c8-5218593d3afb 59248-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19810101 UNAPPROVED MEDICAL GAS Visiting Home Care Services Inc. dba VNA Medical Equipment and Supplies OXYGEN 99 L/100L 59256-001_45127a3b-d7ca-444b-9d39-a3eb115caeb2 59256-001 HUMAN OTC DRUG Audiologists Choice EARWAX REMOVAL SYSTEM Earwax Removal CARBAMIDE PEROXIDE LIQUID TOPICAL 20141128 OTC MONOGRAPH FINAL part344 Oaktree Products Inc. CARBAMIDE PEROXIDE 65 mg/mL 59260-035_24723e60-7340-45e9-96de-a596581b9309 59260-035 HUMAN OTC DRUG Rocky Mountain Sunscreen Octinoxate, octisalate, octocrylene, titanium dioxide CREAM TOPICAL 20100519 OTC MONOGRAPH FINAL part352 Creative Cosmetics Inc. dba CCI OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 5; 10; 1.3 mL/100mL; mL/100mL; mL/100mL; mL/100mL 59260-035_f55942c2-5fe3-4439-8560-6bab2b2a4ffb 59260-035 HUMAN OTC DRUG Rocky Mountain Sunscreen Octinoxate, octisalate, octocrylene, titanium dioxide CREAM TOPICAL 20100519 OTC MONOGRAPH FINAL part352 Creative Cosmetics Inc. dba CCI OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 5; 10; 1.3 L/100L; L/100L; L/100L; L/100L 59260-135_257ab7e9-e1f0-40ca-8275-d99de03f7c72 59260-135 HUMAN OTC DRUG Rocky Mountain Sunscreen Octinoxate, octisalate, octocrylene, titanium dioxide CREAM TOPICAL 20100519 OTC MONOGRAPH FINAL part352 Creative Cosmetics Inc. dba CCI OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 5; 10; 1.3 mL/100mL; mL/100mL; mL/100mL; mL/100mL 59260-135_b29bf84e-28b4-4bbd-be59-ca8d19aab9f4 59260-135 HUMAN OTC DRUG Rocky Mountain Sunscreen Octinoxate, octisalate, octocrylene, titanium dioxide CREAM TOPICAL 20100519 OTC MONOGRAPH FINAL part352 Creative Cosmetics Inc. dba CCI OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 5; 10; 1.3 L/100L; L/100L; L/100L; L/100L 59262-100_fe653f01-aff8-43f5-88e3-3dd4afa55dc1 59262-100 HUMAN OTC DRUG Arnica Active arnica montana, calendula officinalis flowering top, hypericum perforatum and symphytum officinale whole TABLET, ORALLY DISINTEGRATING ORAL 20140327 UNAPPROVED HOMEOPATHIC Similasan Corporation ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; SYMPHYTUM OFFICINALE WHOLE 4; 4; 4; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 59262-101_78d98cbc-3096-4297-beff-56727962a860 59262-101 HUMAN OTC DRUG Arnica Active arnica montana, calendula officinalis flowering top, hypericum perforatum and symphytum officinale whole SPRAY TOPICAL 20140327 UNAPPROVED HOMEOPATHIC Similasan Corporation ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; SYMPHYTUM OFFICINALE WHOLE 4; 4; 4; 6 [hp_X]/90mL; [hp_X]/90mL; [hp_X]/90mL; [hp_X]/90mL 59262-240_0f56aa5a-c5fa-4740-9346-0c9168897d0a 59262-240 HUMAN OTC DRUG Sinus Relief Kali bichromicum, Luffa operculata, Sabadilla SPRAY NASAL 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation LUFFA OPERCULATA FRUIT; POTASSIUM DICHROMATE; SCHOENOCAULON OFFICINALE SEED 6; 6; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL 59262-241_a91f7809-dc85-48e1-8862-26ca1ccdd335 59262-241 HUMAN OTC DRUG Nasal Allergy Relief Cardiospermum 6X, Galphimia glauca 6X, Luffa operculata 6X, Sabadilla 6X SPRAY NASAL 20100515 UNAPPROVED HOMEOPATHIC Similasan Corporation CARDIOSPERMUM HALICACABUM FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED 6; 6; 6; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL 59262-257_c984ba19-59bb-4129-9c27-a9adbbf3ccba 59262-257 HUMAN OTC DRUG Kids Cold and Mucus Relief Expectorant Antimony Pentasulfide and Potassium Iodide and Polygala Senega Root SYRUP ORAL 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ANTIMONY PENTASULFIDE; POLYGALA SENEGA ROOT; POTASSIUM IODIDE 12; 8; 12 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL 59262-259_792618fe-272b-4d44-8c53-74f36ae71782 59262-259 HUMAN OTC DRUG Kids Cough and Fever Relief Atropa belladonna and Drosera rotundifolia and Prunus laurocerasus leaf and Rumex crispus root and Polygala Senega Root and Verbascum thapsus SYRUP ORAL 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; DROSERA ROTUNDIFOLIA; POLYGALA SENEGA ROOT; PRUNUS LAUROCERASUS LEAF; RUMEX CRISPUS ROOT; VERBASCUM THAPSUS 6; 3; 6; 4; 4; 6 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL 59262-260_26b66935-b8de-4e1f-a02f-f76363de8630 59262-260 HUMAN OTC DRUG Cough Relief Atropa Belladonna and Drosera Rotundifolia and Polygala Senega Root and Prunus Laurocerasus Leaf and Rumex Crispus root and Verbascum Thapsus SYRUP ORAL 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; DROSERA ROTUNDIFOLIA; POLYGALA SENEGA ROOT; PRUNUS LAUROCERASUS LEAF; RUMEX CRISPUS ROOT; VERBASCUM THAPSUS 6; 3; 6; 4; 4; 6 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL 59262-261_95f7725c-4402-49fa-87cc-7eeb6c05e799 59262-261 HUMAN OTC DRUG Mucus Relief Antimony Pentasulfide and Polygala Senega Root and Potassium Iodide SYRUP ORAL 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ANTIMONY PENTASULFIDE; POLYGALA SENEGA ROOT; POTASSIUM IODIDE 12; 8; 12 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL 59262-262_a1af27b4-608d-47c1-8479-6d5edfbfb509 59262-262 HUMAN OTC DRUG Cold and Mucus Relief Junior Strength antimony pentasulfide, potassium iodide and polygala senega root TABLET, ORALLY DISINTEGRATING ORAL 20140401 UNAPPROVED HOMEOPATHIC Similasan Corporation ANTIMONY PENTASULFIDE; POLYGALA SENEGA ROOT; POTASSIUM IODIDE 12; 8; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1 59262-263_a10e0e92-a028-421e-8db1-e3d623d51f27 59262-263 HUMAN OTC DRUG Cough and Fever Relief Junior Strength Atropa belladonna, Drosera rotundifolia, Prunus laurocerasus leaf, Rumex crispus root, Polygala Senega Root and Verbascum thapsus TABLET, ORALLY DISINTEGRATING ORAL 20140401 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; DROSERA ROTUNDIFOLIA; POLYGALA SENEGA ROOT; PRUNUS LAUROCERASUS LEAF; RUMEX CRISPUS ROOT; VERBASCUM THAPSUS 6; 4; 6; 4; 4; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 59262-264_212ad01f-7baf-4373-a4c1-e56779ebd272 59262-264 HUMAN OTC DRUG Immune Support Junior Strength Echinacea angustifolia TABLET, ORALLY DISINTEGRATING ORAL 20140401 UNAPPROVED HOMEOPATHIC Similasan Corporation ECHINACEA ANGUSTIFOLIA 33 [hp_X]/1 59262-271_99484791-d020-4de9-899d-e953f8057554 59262-271 HUMAN OTC DRUG Ear Relief Chamomilla and Mercurius Solubilis and Sulphur SOLUTION AURICULAR (OTIC) 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR 10; 15; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 59262-272_29b52fe4-50ee-4b81-a384-db8ef16c3e13 59262-272 HUMAN OTC DRUG Ear Wax Relief Causticum 12X, Graphites 15X, Lachesis 12X, Lycopodium 12X SOLUTION AURICULAR (OTIC) 20030601 UNAPPROVED HOMEOPATHIC Similasan Corporation CAUSTICUM; GRAPHITE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE 12; 15; 12; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 59262-273_49341306-7cca-45d8-9b6a-f77d2c33efae 59262-273 HUMAN OTC DRUG Kids Ear Relief Matricaria recutita, Mercurius Solubilis, Anemone patens and Sulphur SOLUTION AURICULAR (OTIC) 20140215 UNAPPROVED HOMEOPATHIC Similasan Corporation ANEMONE PATENS; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; SULFUR 12; 10; 15; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 59262-274_5afb65f7-c86e-4663-a7e1-238c7648e7c4 59262-274 HUMAN OTC DRUG Childrens Earache Relief Chamomilla 10X, Mercurius solubilis 15X, Pulsatilla 12X, Sulphur 12X SOLUTION AURICULAR (OTIC) 20070101 UNAPPROVED HOMEOPATHIC Similasan Corporation CHAMOMILE; MERCURIUS SOLUBILIS; PULSATILLA PATENS; SULFUR 10; 15; 12; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 59262-345_d84368ac-13ea-428e-94b4-609643fcb3bc 59262-345 HUMAN OTC DRUG Dry Eye Relief Belladonna, Euphrasia, Mercurius sublimatus SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; EUPHRASIA STRICTA; MERCURIC CHLORIDE 6; 6; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 59262-346_96a982f0-c42d-4609-8ec8-e6b5d880533b 59262-346 HUMAN OTC DRUG Allergy Eye Relief Apis 6X, Euphrasia 6X, Sabadilla 6X SOLUTION/ DROPS OPHTHALMIC 19850101 UNAPPROVED HOMEOPATHIC Similasan Corporation APIS MELLIFERA; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED 6; 6; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 59262-347_07f41be0-781e-4023-bf72-506404ebec74 59262-347 HUMAN OTC DRUG Computer Eye Relief Conium maculatum and Natrium muriaticum and Ruta graveolens and Senega officinalis SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation CONIUM MACULATUM FLOWERING TOP; POLYGALA SENEGA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE 6; 6; 6; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 59262-348_f12cdc02-422f-4aaa-9a15-628c712a2d59 59262-348 HUMAN OTC DRUG Irritated Eye Relief Atropa Belladonna, Calcium Sulfide and Euphrasia Stricta SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; CALCIUM SULFIDE; EUPHRASIA STRICTA 6; 12; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 59262-350_f51fba07-144b-493a-9955-56d92dcf59a9 59262-350 HUMAN OTC DRUG Stye Eye Relief Conium maculatum 6X, Graphites 12X, Sulphur 12X SOLUTION/ DROPS OPHTHALMIC 20040101 UNAPPROVED HOMEOPATHIC Similasan Corporation CONIUM MACULATUM FLOWERING TOP; GRAPHITE; SULFUR 6; 12; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 59262-351_2bfd38bc-3832-4198-8cf3-e166d4fae95c 59262-351 HUMAN OTC DRUG Dry Eye Relief Belladonna 6X, Euphrasia 6X, Mercurius sublimatus 6X SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; EUPHRASIA STRICTA; MERCURIC CHLORIDE 6; 6; 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL 59262-352_3e7ad75f-97e1-40d2-8432-d4b8fdf24e68 59262-352 HUMAN OTC DRUG Dry Eye Relief Atropa Belladonna and Euphrasia Stricta and Mercuric Chloride SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; EUPHRASIA STRICTA; MERCURIC CHLORIDE 6; 6; 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL 59262-353_c9d5d5a9-2bf2-4de3-809f-76c3a3774a37 59262-353 HUMAN OTC DRUG Allergy Eye Relief Apis Mellifera and Euphrasia Stricta and Schoenocaulon Officinale Seed SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation APIS MELLIFERA; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED 6; 6; 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL 59262-354_e18cae59-1f2e-4f85-a147-86cbff87f37f 59262-354 HUMAN OTC DRUG Allergy Eye Relief Apis and Euphrasia and Sabadilla SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation APIS MELLIFERA; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED 6; 6; 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL 59262-355_836a4a8d-ee36-46a7-a926-3fbfc144ce25 59262-355 HUMAN OTC DRUG Computer Eye Relief Conium maculatum, Natrium muriaticum, Ruta graveolens, Senega officinalis SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation CONIUM MACULATUM FLOWERING TOP; POLYGALA SENEGA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE 6; 6; 6; 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL 59262-356_c967127a-39cc-4987-b8d2-504794aab3a7 59262-356 HUMAN OTC DRUG Irritated Eye Relief Atropa belladonna, Euphrasia stricta and Calcium sulfide SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; CALCIUM SULFIDE; EUPHRASIA STRICTA 6; 12; 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL 59262-357_7f7dc1d5-a889-4315-9c0d-fd2bc3aeaf78 59262-357 HUMAN OTC DRUG Tired Eye Relief conium maculatum flowering top, sodium chloride, ruta graveolens flowering top and polygala senega root SOLUTION/ DROPS OPHTHALMIC 20140211 UNAPPROVED HOMEOPATHIC Similasan Corporation CONIUM MACULATUM FLOWERING TOP; POLYGALA SENEGA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE 6; 6; 6; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 59262-358_3008640b-4c15-4cfc-b39a-91e841830bf7 59262-358 HUMAN OTC DRUG Complete Eye Relief atropa belladonna, euphrasia stricta and mercuric chloride SOLUTION/ DROPS OPHTHALMIC 20140211 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; EUPHRASIA STRICTA; MERCURIC CHLORIDE 6; 6; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 59262-359_b5b398eb-c6fc-4cc4-9de7-3b955b0768a6 59262-359 HUMAN OTC DRUG Complete Eye Relief Single Use atropa belladonna, euphrasia stricta and mercuric chloride SOLUTION/ DROPS OPHTHALMIC 20140215 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; EUPHRASIA STRICTA; MERCURIC CHLORIDE 6; 6; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 59262-360_b30c07c9-d431-48de-ac2b-5347fecf8ed1 59262-360 HUMAN OTC DRUG Aging Eye Relief jacobaea maritima, sodium chloride and ruta graveolens flowering top SOLUTION/ DROPS OPHTHALMIC 20140401 UNAPPROVED HOMEOPATHIC Similasan Corporation JACOBAEA MARITIMA; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE 6; 6; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 59262-361_dbf9fcf5-c40c-445d-81c9-5391e8b7b941 59262-361 HUMAN OTC DRUG Kids Allergy Eye Relief Apis and Euphrasia and Pulsatilla and Sabadilla SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation APIS MELLIFERA; EUPHRASIA STRICTA; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED 6; 6; 6; 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL 59262-362_5816bb34-0dd7-487a-8f61-7e2735343e9f 59262-362 HUMAN OTC DRUG Kids Irritated Eye Relief Belladonna and Euphrasia and Hepar Sulphuris and Thuja LIQUID OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; CALCIUM SULFIDE; EUPHRASIA STRICTA; PLATYCLADUS ORIENTALIS LEAF 6; 12; 6; 15 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL 59262-400_7d6528f8-8408-4d2b-b8a3-4d73fac8c803 59262-400 HUMAN OTC DRUG Burn Recovery calendula officinalis flowering top, lytta vesicatoria, echinacea, unspecified, urtica urens SPRAY TOPICAL 20141101 UNAPPROVED HOMEOPATHIC Similasan Corporation CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; LYTTA VESICATORIA; URTICA URENS 4; 4; 6; 4 [hp_X]/90mL; [hp_X]/90mL; [hp_X]/90mL; [hp_X]/90mL 59262-401_18791ac0-d4e5-427a-bd3e-0393d67ffabd 59262-401 HUMAN OTC DRUG Itch Relief apis mellifera, lachesis muta venom, ledum palustre twig and urtica urens LIQUID TOPICAL 20141101 UNAPPROVED HOMEOPATHIC Similasan Corporation APIS MELLIFERA; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; URTICA URENS 12; 12; 6; 8 [hp_X]/7.5mL; [hp_X]/7.5mL; [hp_X]/7.5mL; [hp_X]/7.5mL 59262-600_6c6fc30f-6221-42ac-a510-b39ae42ba85a 59262-600 HUMAN OTC DRUG Stress and Tension Relief Asafetida, Crataegus Fruit, Lycopus Virginicus and Passiflora Incarnata Flowering Top GLOBULE ORAL 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ASAFETIDA; CRATAEGUS FRUIT; LYCOPUS VIRGINICUS; PASSIFLORA INCARNATA FLOWERING TOP 4; 4; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 59262-601_088190e0-6a24-4b6c-a72a-00bd79ae7895 59262-601 HUMAN OTC DRUG Sleeplessness Relief Avena sativa and Hepar sulphuris and Pulsatilla and Zincum valerianicum GLOBULE ORAL 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ANEMONE PATENS; AVENA SATIVA FLOWERING TOP; CALCIUM SULFIDE; ZINC VALERATE DIHYDRATE 15; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 59262-602_1681865e-e60f-4da2-8c7c-6248e69c4733 59262-602 HUMAN OTC DRUG Anxiety Relief Argentum nitricum and Strophantus gratus GLOBULE ORAL 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation SILVER NITRATE; STROPHANTHUS GRATUS SEED 15; 12 [hp_X]/1; [hp_X]/1 59275-001_3ce1e06a-37b8-4d15-9ea8-dc45f983ba0b 59275-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19911010 UNAPPROVED MEDICAL GAS United Welding Supply Co., Inc OXYGEN 990 mL/L 59276-209_71cf7fd2-76b4-4d0a-8150-6fb274f8db69 59276-209 HUMAN OTC DRUG A-Med brand First Aid Eye and Skin-Rinse Purified Water SOLUTION CUTANEOUS; OPHTHALMIC; TOPICAL 20131101 OTC MONOGRAPH FINAL part349 1602041 Ontario Limited WATER 98.577 mL/100mL 59279-502_ee375084-8175-479a-88af-1ac675b4fbe3 59279-502 HUMAN OTC DRUG SOLV X salicylic acid SHAMPOO TOPICAL 19940101 OTC MONOGRAPH FINAL part358H Mediceutical Laboratories, LTD SALICYLIC ACID 18 mg/L 59279-505_5481e2f4-08c6-46e2-a36e-d50b07da7b63 59279-505 HUMAN OTC DRUG X FOLATE coal tar SHAMPOO TOPICAL 19930101 OTC MONOGRAPH FINAL part358H Mediceutical Laboratories, LTD COAL TAR 50 mg/mL 59279-507_e60f6e22-ceb0-400b-ba24-3ac3f6a5df6d 59279-507 HUMAN OTC DRUG Mediceuticals X-Derma Dry Scalp and Hair Treatment Salicylic Acid SHAMPOO TOPICAL 20121127 OTC MONOGRAPH FINAL part358H Mediceutical Laboratories, Ltd. SALICYLIC ACID 1.8 g/100mL 59279-514_bb13fe13-32ce-4d7c-988e-1bfff481eee1 59279-514 HUMAN OTC DRUG THERAPEUTIC pyrithione zinc RINSE TOPICAL 20070101 OTC MONOGRAPH FINAL part358H Mediceutical Laboratories, LTD PYRITHIONE ZINC 5 mg/mL 59279-530_c5838590-724c-40c4-8ebf-bf09a6404ca2 59279-530 HUMAN OTC DRUG THERA RX triclosan SOLUTION TOPICAL 19970101 OTC MONOGRAPH NOT FINAL part333E Mediceutical Laboratories, LTD TRICLOSAN 3 mg/mL 59294-000_8adabb57-7de3-4895-9b6d-ef72c1923898 59294-000 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL LIQUID TOPICAL 20130711 OTC MONOGRAPH NOT FINAL part333A Global Healthcare ISOPROPYL ALCOHOL 70 g/100g 59294-001_c6fdb60b-2156-461a-a8e0-f9ff4be432fa 59294-001 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL LIQUID TOPICAL 20130711 OTC MONOGRAPH NOT FINAL part333A Global Healthcare ISOPROPYL ALCOHOL 70 g/100g 59301-001_0d669e84-71d3-4fc2-b297-c7d2e2e86bb2 59301-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Oxygen Support Systems Inc OXYGEN 99 L/100L 59303-1001_9e6a9f44-820d-4499-8e56-5fb09e42865b 59303-1001 HUMAN OTC DRUG Hanip Gargle apple fragrance Sodium Fluoride MOUTHWASH DENTAL 20130713 OTC MONOGRAPH FINAL part355 PISHONANC Co, Ltd SODIUM FLUORIDE 20 mg/100000mL 59303-2001_1bb50883-46aa-49e2-aee3-a2e87e0a62b9 59303-2001 HUMAN OTC DRUG Hanip Gargle pine fragrance Sodium Fluoride MOUTHWASH DENTAL 20130713 OTC MONOGRAPH FINAL part355 PISHONANC Co, Ltd SODIUM FLUORIDE 20 mg/100000mL 59305-028_9d91ffac-cb8b-4b94-8107-57f39732dd7b 59305-028 HUMAN OTC DRUG Senior B Skin Protectant CREAM TOPICAL 20130710 OTC MONOGRAPH FINAL part347 NEAT FEAT PRODUCTS ZINC ACETATE 1.5 g/75g 59305-030_0498ea9c-bc86-4a00-80ae-fa2572977335 59305-030 HUMAN OTC DRUG Cool Foot Antiperspirant SPRAY TOPICAL 20130710 OTC MONOGRAPH FINAL part350 NEAT FEAT PRODUCTS ALUMINUM CHLOROHYDRATE 12 g/125g 59310-175_6e115673-0ad2-4d69-9748-66354e026567 59310-175 HUMAN PRESCRIPTION DRUG QVAR beclomethasone dipropionate AEROSOL, METERED RESPIRATORY (INHALATION) 20001006 20151130 NDA NDA020911 Teva Respiratory, LLC BECLOMETHASONE DIPROPIONATE 40 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59310-202_d36edb9d-8ccd-44d9-bb90-f2ad7523c988 59310-202 HUMAN PRESCRIPTION DRUG QVAR beclomethasone dipropionate AEROSOL, METERED RESPIRATORY (INHALATION) 20110119 NDA NDA020911 Teva Respiratory, LLC BECLOMETHASONE DIPROPIONATE 40 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59310-202_db1ab5c0-99ed-4020-9a89-67a7831a2bd4 59310-202 HUMAN PRESCRIPTION DRUG QVAR beclomethasone dipropionate AEROSOL, METERED RESPIRATORY (INHALATION) 20140915 NDA NDA020911 Teva Respiratory, LLC BECLOMETHASONE DIPROPIONATE 40 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59310-204_d36edb9d-8ccd-44d9-bb90-f2ad7523c988 59310-204 HUMAN PRESCRIPTION DRUG QVAR beclomethasone dipropionate AEROSOL, METERED RESPIRATORY (INHALATION) 20110121 NDA NDA020911 Teva Respiratory, LLC BECLOMETHASONE DIPROPIONATE 80 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59310-204_db1ab5c0-99ed-4020-9a89-67a7831a2bd4 59310-204 HUMAN PRESCRIPTION DRUG QVAR beclomethasone dipropionate AEROSOL, METERED RESPIRATORY (INHALATION) 20140915 NDA NDA020911 Teva Respiratory, LLC BECLOMETHASONE DIPROPIONATE 80 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59310-210_7ddaee68-6f8e-42a3-bed8-375c5833aabe 59310-210 HUMAN PRESCRIPTION DRUG QNASL beclomethasone dipropionate AEROSOL, METERED NASAL 20120416 NDA NDA202813 Teva Respiratory, LLC BECLOMETHASONE DIPROPIONATE 80 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59310-579_bcfbad4e-3bb9-4719-b013-3fb75bf7f3a1 59310-579 HUMAN PRESCRIPTION DRUG PROAIR HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20121203 NDA NDA021457 Teva Respiratory, LLC ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 59316-101_f9cd7654-60ec-4107-9aca-86a8ba3ff701 59316-101 HUMAN OTC DRUG Biofreeze Menthol GEL TOPICAL 20101103 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC. MENTHOL 35 mg/mL 59316-102_e3965c53-99f0-4deb-9f0b-43a6b9c6dfd0 59316-102 HUMAN OTC DRUG BIOFREEZE MENTHOL GEL TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 40 mg/mL 59316-103_6ccd2ab2-e0f6-4d85-959c-f9c19c21f7ab 59316-103 HUMAN OTC DRUG BIOFREEZE COLORLESS MENTHOL GEL TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 40 mg/mL 59316-104_12f49fbc-735d-4c11-a8f0-fb4c0d62c7d6 59316-104 HUMAN OTC DRUG Biofreeze MENTHOL SPRAY TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part348 Performance Health, Inc. MENTHOL 10 mL/100mL 59316-104_9a321f62-5f2f-4870-acc8-c048ec0fe208 59316-104 HUMAN OTC DRUG Biofreeze MENTHOL SPRAY TOPICAL 20110519 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 100 mg/mL 59316-104_cb2ca538-2ad4-4a50-b27d-17ecdfe61815 59316-104 HUMAN OTC DRUG Biofreeze MENTHOL SPRAY TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 100 mg/mL 59316-106_bcc4008e-2828-42e0-bcca-e423f5453d93 59316-106 HUMAN OTC DRUG Perform Menthol GEL TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 31 mg/mL 59316-107_1033e53b-1b8b-4079-8557-d285237b7eab 59316-107 HUMAN OTC DRUG Perform MENTHOL SPRAY TOPICAL 20101117 OTC MONOGRAPH NOT FINAL part348 Performance Health Inc. MENTHOL 10 mL/100mL 59316-107_2fa1f656-615a-498c-bf2f-a921dda437b0 59316-107 HUMAN OTC DRUG Perform MENTHOL SPRAY TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 100 mg/mL 59316-107_54955d5e-0d56-4674-a964-d720932d86b5 59316-107 HUMAN OTC DRUG Perform MENTHOL SPRAY TOPICAL 20110512 OTC MONOGRAPH NOT FINAL part348 Performance Health Inc. MENTHOL 100 mg/mL 59316-107_7398649f-8634-49f7-9541-67e0e5c10a74 59316-107 HUMAN OTC DRUG Perform MENTHOL SPRAY TOPICAL 20101117 OTC MONOGRAPH NOT FINAL part348 Performance Health Inc. MENTHOL 10 mL/100mL 59316-108_53b33134-3411-453b-807b-be0c1571bff5 59316-108 HUMAN OTC DRUG Perform MENTHOL GEL TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 31 mg/mL 59316-109_987d0396-185c-40a0-a234-afdced00e0ec 59316-109 HUMAN OTC DRUG PERFORM MENTHOL SPRAY TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 104 mg/mL 59316-114_7ae58304-b4b3-412c-83b2-30f0dd980576 59316-114 HUMAN OTC DRUG BIOFREEZE MENTHOL SPRAY TOPICAL 20140219 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 105 mg/mL 59316-205_cf204c0d-5c05-4536-b55b-951b82d76fe0 59316-205 HUMAN OTC DRUG Biofreeze Roll-On MENTHOL GEL TOPICAL 20130117 OTC MONOGRAPH FINAL part348 Performance Health Inc. MENTHOL 40 mg/mL 59316-206_4e4e0694-b443-4b1c-8a80-f00c908fb0bc 59316-206 HUMAN OTC DRUG Biofreeze Colorless Roll-On MENTHOL GEL TOPICAL 20130117 OTC MONOGRAPH FINAL part348 Performance Health Inc. MENTHOL 40 mg/mL 59316-301_f1b22772-bfad-42dc-acad-042081d082ef 59316-301 HUMAN OTC DRUG dynaFreeze MENTHOL LIQUID TOPICAL 20100825 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 35 mg/mL 59321-031_a96d3761-c870-4ae7-98d6-3dc9cd54ee04 59321-031 HUMAN OTC DRUG SHU JIN LU CAMPHOR AND MENTHOL SPRAY TOPICAL 20110407 OTC MONOGRAPH NOT FINAL part348 GUANGXI YULIN PHARMACEUTICAL CO LTD CAMPHOR (SYNTHETIC); MENTHOL 5.5; 5.5 g/100mL; g/100mL 59321-032_cee6bf4e-c6e7-40c2-abfe-a3df37fd67c7 59321-032 HUMAN OTC DRUG JIN GU WANG CAMPHOR AND MENTHOL SPRAY TOPICAL 20110407 OTC MONOGRAPH NOT FINAL part348 GUANGXI YULIN PHARMACEUTICAL CO LTD CAMPHOR (SYNTHETIC); MENTHOL 5.5; 5.5 g/100mL; g/100mL 59321-033_15b44819-929a-4388-b350-eb5b49160a57 59321-033 HUMAN OTC DRUG YUN XIANG JING MENTHOL LINIMENT PERCUTANEOUS; TRANSDERMAL 20021008 OTC MONOGRAPH NOT FINAL part348 GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD MENTHOL 3 g/100mL 59321-055_16f9a758-7517-411f-a354-721de259bd36 59321-055 HUMAN OTC DRUG ZHENG GU SHUI CAMPHOR, MENTHOL LINIMENT PERCUTANEOUS; TRANSDERMAL 20001019 OTC MONOGRAPH NOT FINAL part348 GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD CAMPHOR (SYNTHETIC); MENTHOL 5.6; 5.6 g/100mL; g/100mL 59332-001_a25da9ed-2464-435f-be97-c87e26548f79 59332-001 HUMAN OTC DRUG Sprayable Energy caffeinum SPRAY TOPICAL 20130820 UNAPPROVED HOMEOPATHIC Spayable Energy LLC CAFFEINE 1 [hp_X]/8mL 59336-001_0338da5d-96b1-4707-b76b-524fa1c1731a 59336-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20131212 NDA NDA205767 JW Welding Supplies & Tools OXYGEN 99 L/100L 59338-775_e116bb91-6743-11e3-949a-0800200c9a66 59338-775 HUMAN PRESCRIPTION DRUG Feraheme ferumoxytol INJECTION INTRAVENOUS 20090713 NDA NDA022180 AMAG Pharmaceuticals, Inc. FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE 510 mg/17mL Parenteral Iron Replacement [EPC],Iron [Chemical/Ingredient] 59342-5003_c6811495-e336-41f3-ae4d-3d963705cfb2 59342-5003 HUMAN OTC DRUG Olbas Pastilles Menthol PASTILLE ORAL 20100324 OTC MONOGRAPH FINAL part341 G. R. Lane Health Products Limited MENTHOL 10 mg/1 59351-0301_838a06af-d580-4197-9773-8e2932b35111 59351-0301 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Pink Benefit (105) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59351-0302_b3f874e6-1dcd-4182-a8fb-adcf143152eb 59351-0302 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Pink Remedy (110) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59351-0303_d83c1bec-b14e-46a3-a1ad-0bed70ebe183 59351-0303 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Rose Cocoon (115) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59351-0304_cd4c3876-9342-43bc-8aaf-140915b3f3d3 59351-0304 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Hydra Beige (120) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59351-0305_002ae683-265f-4baf-a1d2-daf8b2741a0a 59351-0305 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Mauve Renew (125) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59351-0306_bb14a74d-47c2-4f7d-bdb5-beb04ae80574 59351-0306 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Active Mauve (135) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59351-0307_f243cc0e-70c6-4c7d-98b4-1a74d502757f 59351-0307 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Pink Protect (145) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59351-0308_cb07f5a0-9ef3-4d66-838e-c933f1035c9e 59351-0308 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Berry Bliss (245) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59351-0309_9d6480af-0d10-40b9-b599-b0007df50adf 59351-0309 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Purple Rescue (335) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59351-0310_c80f9eee-4083-4aef-8553-5e25848ec7ce 59351-0310 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Fuscia Theraphy (345) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59351-0311_d607ae15-9903-45b4-8f8d-69c378a40446 59351-0311 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Pink Spa (365) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59351-0312_8cd0164f-71fb-4f4a-9a5a-60ba895a0d99 59351-0312 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - SOS Red (525) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59351-0313_f24fe37a-37e0-4bb2-859e-b0d31f980553 59351-0313 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Red Action (565) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59351-0314_22393892-de11-455d-845b-ba153693d40c 59351-0314 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Cherry Boost (585) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59351-0315_8358ce7f-9bf2-4815-96be-67e9df7e9277 59351-0315 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Ivory (120) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL 59351-0316_5aa1e521-e75f-436d-b1ad-9790ca611d8b 59351-0316 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - True Ivory (130) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL 59351-0317_fe96166f-5cd4-468c-b1c8-102cea027ee0 59351-0317 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Soft Ivory (220) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL 59351-0318_8790d569-f225-481e-92d0-f09a24946f16 59351-0318 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Warm Ivory (230) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL 59351-0319_ba3d0b64-be20-409c-a794-f3091e855a87 59351-0319 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Soft Beige (240) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL 59351-0320_cf649e76-8230-4b17-a49e-aaceeefefb31 59351-0320 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Classic Beige (250) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL 59351-0321_56f21937-42b3-475c-8b6d-1fe6f08b6172 59351-0321 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Natural Ivory (260) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL 59351-0322_66a275fc-e3c3-44d8-b287-c72edb2f7de2 59351-0322 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - True Nude (320) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL 59351-0323_1c03af16-3396-4b59-ae90-72c22011728e 59351-0323 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Sand (330) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL 59351-0324_db985500-6b1b-4f83-b538-7f7d94b5a2d1 59351-0324 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Nude (340) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL 59351-0326_fa1b1d27-b333-4066-b7db-10b0341cd251 59351-0326 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Warm Sand (420) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL 59351-0327_f5308970-8390-452c-9469-c05a3007d1a6 59351-0327 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Soft Honey (430) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL 59351-0328_73ad7bac-ffca-42b8-b596-ce20b3dd970b 59351-0328 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Natural Beige (440) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL 59351-0329_b06292c4-3535-41fa-9f77-827e95e27124 59351-0329 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Natural Caramel (520) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL 59351-0330_40abd583-8eca-4bcc-97ec-686bee7fe559 59351-0330 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Warm Caramel (530) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL 59351-0331_c585fe29-f477-437f-a440-b3e85fb76d98 59351-0331 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Comfortably Nude (116) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59351-0332_62c3d318-0617-4fdb-8a24-ae1bb90b7d08 59351-0332 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Peach Fusion (117) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59351-0333_2658a9fb-e6a2-4cf5-9968-d63133ddb5aa 59351-0333 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Coral Reflection (119) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL 59365-5006_91658000-fc24-4b9f-8b8b-46b72e4169fe 59365-5006 HUMAN PRESCRIPTION DRUG Ferric Subsulfate Ferric Subsulfate SOLUTION TOPICAL 19921001 UNAPPROVED DRUG OTHER CooperSurgical, Inc. FERRIC SUBSULFATE 259 mg/g Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 59365-5030_a0e73a6d-4042-442b-903a-dc27c7b054cf 59365-5030 HUMAN PRESCRIPTION DRUG TRIMO SAN Oxyquinoline Sulfate and Sodium Lauryl Sulfate JELLY VAGINAL 19770401 UNAPPROVED DRUG OTHER CooperSurgical, Inc. OXYQUINOLINE SULFATE; SODIUM LAURYL SULFATE .25; .1 mg/g; mg/g 59365-6064_6311591d-59cd-4f39-86be-3054f0e5d389 59365-6064 HUMAN PRESCRIPTION DRUG Lugols Strong Iodine Iodine and Potassium Iodide SOLUTION TOPICAL 19921001 UNAPPROVED DRUG OTHER CooperSurgical, Inc. IODINE; POTASSIUM IODIDE .05; .105 g/mL; g/mL 59365-6065_9eb6dd79-ecfd-45c8-91b5-47bd70249f2d 59365-6065 HUMAN PRESCRIPTION DRUG Ferric Subsulfate Ferric Subsulfate SOLUTION TOPICAL 19921001 UNAPPROVED DRUG OTHER CooperSurgical, Inc. FERRIC SUBSULFATE 259 mg/g Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 59371-6500_b3f15c3f-63d0-44fd-b80f-edbef8a56230 59371-6500 HUMAN OTC DRUG Hydrating Instant Hand Sanitizer Alcohol GEL TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part333E Micrylium Laboratories ALCOHOL 315 mL/450mL 59371-6510_c0c6a22d-57e5-4689-af24-17a952cc399f 59371-6510 HUMAN OTC DRUG Hydrating Instant Hand Sanitizer Alcohol GEL TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part333E Micrylium Laboratories ALCOHOL 42 mL/60mL 59378-001_9bf72fb1-c7e5-49a4-9d39-e4ca44889ae4 59378-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130701 UNAPPROVED MEDICAL GAS Jayco Industrial Supply Inc OXYGEN 995 mL/L 59385-012_2c415010-bb5c-11e3-a5e2-0800200c9a66 59385-012 HUMAN PRESCRIPTION DRUG BUNAVAIL buprenorphine and naloxone FILM BUCCAL 20140805 NDA NDA205637 BioDelivery Sciences International, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2.1; .3 mg/1; mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA],Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 59385-014_2c415010-bb5c-11e3-a5e2-0800200c9a66 59385-014 HUMAN PRESCRIPTION DRUG BUNAVAIL buprenorphine and naloxone FILM BUCCAL 20140805 NDA NDA205637 BioDelivery Sciences International, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 4.2; .7 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 59385-016_2c415010-bb5c-11e3-a5e2-0800200c9a66 59385-016 HUMAN PRESCRIPTION DRUG BUNAVAIL buprenorphine and naloxone FILM BUCCAL 20140805 NDA NDA205637 BioDelivery Sciences International, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 6.3; 1 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 59387-001_cdf14795-54e6-4ed4-a8f5-7163cb1a1f1d 59387-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19800101 UNAPPROVED MEDICAL GAS A-Welders and Medical Supply, Inc OXYGEN 99 L/100L 59387-002_e3db1d0b-f0d0-41d4-b6d2-2f8235cf8cac 59387-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19800101 UNAPPROVED MEDICAL GAS A-Welders and Medical Supply, Inc NITROGEN 99 L/100L 59390-036_9c9dbeb1-1b8e-4e93-b1a1-d65667a11964 59390-036 HUMAN OTC DRUG 12 Hour Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20010601 OTC MONOGRAPH FINAL part341 Altaire Pharmaceuticals Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 59390-140_1419e0b7-cb1e-48fd-ab83-edfa70ddd693 59390-140 HUMAN PRESCRIPTION DRUG Ofloxacin ophthalmic Ofloxacin SOLUTION OPHTHALMIC 20130531 ANDA ANDA202692 Altaire Pharmaceuticals Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 59390-177_8de55300-9137-4213-bd54-74d93dee9299 59390-177 HUMAN OTC DRUG Naphazoline HCI And Pheniramine Maleate NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE SOLUTION/ DROPS OPHTHALMIC 20101006 ANDA ANDA078208 Altaire Pharmaceuticals Inc. NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .027; .315 mL/100mL; mL/100mL 59390-181_50f34194-b263-4241-a61b-94d4a615a543 59390-181 HUMAN PRESCRIPTION DRUG ALTACAINE Tetracaine Hydrochloride SOLUTION OPHTHALMIC 20020201 UNAPPROVED DRUG OTHER Altaire Pharmaceuticals Inc. TETRACAINE HYDROCHLORIDE 5 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 59390-192_9fe4d614-4a9c-49d9-98b8-79e6218bdb40 59390-192 HUMAN PRESCRIPTION DRUG HOMATROPINE HYDROBROMIDE OPHTHALMIC Homatropine Hydrobromide SOLUTION OPHTHALMIC 20130516 UNAPPROVED DRUG OTHER Altaire Pharmaceuticals Inc. HOMATROPINE HYDROBROMIDE 50 mg/mL Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 59390-205_aad82660-736c-4cbb-9426-c8651dec3718 59390-205 HUMAN PRESCRIPTION DRUG Fluorecein sodium and Proparacaine Hydrochloride Fluorecein sodium and Proparacaine Hydrochloride Opthahalmic Solution SOLUTION/ DROPS OPHTHALMIC 19890330 UNAPPROVED DRUG OTHER Altaire Pharmaceuticals, Inc. FLUORESCEIN SODIUM; PROPARACAINE HYDROCHLORIDE .5; 2.5 mg/mL; mg/mL Diagnostic Dye [EPC],Dyes [MoA],Local Anesthesia [PE],Local Anesthetic [EPC] 59390-206_2f3d7acd-3890-4aff-bf27-539b7ba436f8 59390-206 HUMAN PRESCRIPTION DRUG Fluorescein Sodium and Benoxinate Hydrochloride Fluorescein Sodium and Benoxinate Hydrochloride SOLUTION OPHTHALMIC 20000621 UNAPPROVED DRUG OTHER Altaire Pharmaceuticals Inc. BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM 4; 2.5 mg/mL; mg/mL Diagnostic Dye [EPC],Dyes [MoA] 59397-3310_b0a513a5-1b60-4cfd-9d6f-8c731027edc2 59397-3310 HUMAN OTC DRUG OFFBite and Itch Rel Bite and Itch Relief Benzocaine, Phenol, Camphor LIQUID TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part348 S. C. Johnson & Son, Inc. BENZOCAINE; CAMPHOR (NATURAL); PHENOL .05; .03; .0135 g/g; g/g; g/g 59400-001_a6781cb9-b36d-488c-9689-8bb6be9debd7 59400-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20131029 UNAPPROVED MEDICAL GAS BayCare Home Care, Inc. OXYGEN 210 mL/L 59400-005_a6781cb9-b36d-488c-9689-8bb6be9debd7 59400-005 HUMAN PRESCRIPTION DRUG Oxygen Oxygen LIQUID RESPIRATORY (INHALATION) 20131105 UNAPPROVED MEDICAL GAS BayCare Home Care, Inc. OXYGEN 210 mg/kg 59401-001_571efc8a-9167-4d74-b760-5660f36bb428 59401-001 HUMAN OTC DRUG Manefit Beauty Planner Lavender Wrinkle Lifting Mask Adenosine CREAM TOPICAL 20140717 UNAPPROVED DRUG OTHER Imine Co., Ltd ADENOSINE .08 mg/20mL 59401-002_de7f6d41-d1f4-4eb0-ad29-0fcd257f55f2 59401-002 HUMAN OTC DRUG Manefit Beauty Planner Lily Whitening Brightening Mask Niacinamide CREAM TOPICAL 20140717 UNAPPROVED DRUG OTHER Imine Co., Ltd. NIACINAMIDE 4.6 mg/23mL 59401-003_849456a1-bd9b-4b49-9d9d-9e10c87e1914 59401-003 HUMAN OTC DRUG Manefit Beauty Planner Lily Whitening Eye Patch Niacinamide CREAM TOPICAL 20140718 UNAPPROVED DRUG OTHER Imine Co., Ltd. NIACINAMIDE .06 g/3g 59401-004_15b6e553-ef50-4c64-ac30-0585805357a0 59401-004 HUMAN OTC DRUG Manefit Bling Bling Whitening Platinum Hydrogel Mask Niacinamide CREAM TOPICAL 20140718 UNAPPROVED DRUG OTHER Imine Co., Ltd. NIACINAMIDE .6 g/30g 59401-005_9f61763b-6330-4d42-b4a9-7a6d708fe14c 59401-005 HUMAN OTC DRUG Manefit Bling Bling Wrinkle Gold Hydro Gel Mask Adenosine CREAM TOPICAL 20140718 UNAPPROVED DRUG OTHER Imine Co., Ltd. NIACINAMIDE .012 g/30g 59401-006_823b9d0a-34f1-4eff-8e3e-875fe4aeeca4 59401-006 HUMAN OTC DRUG Sallys Box Loverecipe Peach Mask Allantoin CREAM TOPICAL 20141118 UNAPPROVED DRUG OTHER Imine Co., Ltd ALLANTOIN .004 mg/20mL 59401-007_7b722604-0283-454c-928f-47dddf961053 59401-007 HUMAN OTC DRUG Sallys Box Loverecipe Pomegranate Mask Allantoin CREAM TOPICAL 20141118 UNAPPROVED DRUG OTHER Imine Co., Ltd ALLANTOIN .004 mg/20mL 59401-008_951e28ce-0da0-4262-ab0c-600ba9e8fa05 59401-008 HUMAN OTC DRUG Sallys Box Loverecipe Carrot Mask Allantoin CREAM TOPICAL 20141118 UNAPPROVED DRUG OTHER Imine Co., Ltd ALLANTOIN .004 mg/20mL 59401-009_d3ab743d-370b-4e5f-9a1c-7bbc973e5b9a 59401-009 HUMAN OTC DRUG Sallys Box Loverecipe Paprika Mask Allantoin CREAM TOPICAL 20141118 UNAPPROVED DRUG OTHER Imine Co., Ltd ALLANTOIN .004 mg/20mL 59401-010_112d3ae7-2e1e-48f0-8da3-1725ade0d1bd 59401-010 HUMAN OTC DRUG Sallys Box Secret Garden Lemon Oil Ampoule Mask Niacinamide, Allantoin CREAM TOPICAL 20141119 UNAPPROVED DRUG OTHER Imine Co., Ltd ALLANTOIN; NIACINAMIDE .0042; .105 mg/21mL; mg/21mL 59401-011_431098ef-749e-4e73-9715-20357828c3b3 59401-011 HUMAN OTC DRUG Sallys Box Secret Garden Olive Oil Ampoule Mask Dimethicone CREAM TOPICAL 20141119 UNAPPROVED DRUG OTHER Imine Co., Ltd DIMETHICONE .4988 mg/21mL 59401-012_3cda09cc-1f34-44ce-b9cc-4e3cdb366b72 59401-012 HUMAN OTC DRUG Sallys Box Secret Garden Camellia Oil Ampoule Mask Dimethicone CREAM TOPICAL 20141125 UNAPPROVED DRUG OTHER Imine Co., Ltd DIMETHICONE .42 mg/21mL 59401-013_81619d1a-876a-45de-a54c-6a9e045c23ae 59401-013 HUMAN OTC DRUG Sallys Box Secret Garden Tea Tree Oil Ampoule Mask Allantoin CREAM TOPICAL 20141125 UNAPPROVED DRUG OTHER Imine Co., Ltd ALLANTOIN .0042 mg/21mL 59401-014_3ea05dff-8448-4609-a5dd-a5fee81357a1 59401-014 HUMAN OTC DRUG Sallys Box Secret Garden Sunflower Oil Ampoule Mask Dimethicone CREAM TOPICAL 20141125 UNAPPROVED DRUG OTHER Imine Co., Ltd DIMETHICONE .42 mg/21mL 59401-015_59c4df38-e23a-4271-8420-dffd225dd4c5 59401-015 HUMAN OTC DRUG Sallys Box Delight Collagen Hydrogel Mask Allantoin CREAM TOPICAL 20141202 UNAPPROVED DRUG OTHER Imine Co., Ltd ALLANTOIN .0125 mg/25g 59417-101_1d88d290-e564-4872-9d7d-b14d61ecb2cd 59417-101 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20140827 NDA NDA021977 Shire LLC LISDEXAMFETAMINE DIMESYLATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 59417-102_1d88d290-e564-4872-9d7d-b14d61ecb2cd 59417-102 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20071210 NDA NDA021977 Shire LLC LISDEXAMFETAMINE DIMESYLATE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 59417-103_1d88d290-e564-4872-9d7d-b14d61ecb2cd 59417-103 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20070223 NDA NDA021977 Shire LLC LISDEXAMFETAMINE DIMESYLATE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 59417-104_1d88d290-e564-4872-9d7d-b14d61ecb2cd 59417-104 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20071210 NDA NDA021977 Shire LLC LISDEXAMFETAMINE DIMESYLATE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 59417-105_1d88d290-e564-4872-9d7d-b14d61ecb2cd 59417-105 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20070223 NDA NDA021977 Shire LLC LISDEXAMFETAMINE DIMESYLATE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 59417-106_1d88d290-e564-4872-9d7d-b14d61ecb2cd 59417-106 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20071210 NDA NDA021977 Shire LLC LISDEXAMFETAMINE DIMESYLATE 60 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 59417-107_1d88d290-e564-4872-9d7d-b14d61ecb2cd 59417-107 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20070223 NDA NDA021977 Shire LLC LISDEXAMFETAMINE DIMESYLATE 70 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 59426-001_9afc9895-fd4c-41b3-b20b-360d4b040b47 59426-001 HUMAN OTC DRUG Provodine providone iodine CREAM TOPICAL 20140915 OTC MONOGRAPH NOT FINAL part333E Microdermis Corporation POVIDONE-IODINE 7.5 mg/mL 59427-001_13d96107-e053-472d-aeaf-98cd1e2773ef 59427-001 HUMAN OTC DRUG Origins A PERFECT WORLD AGE DEFENSE TINTED MOISTURIZER SPF 15 octinoxate, octisalate, and avobenzone LIQUID TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. AVOBENZONE; OCTINOXATE; OCTISALATE 2; 7.5; 5 mL/100mL; mL/100mL; mL/100mL 59427-004_775a74fb-7d2a-4e15-a892-4e4a5db04664 59427-004 HUMAN OTC DRUG PLANTSCRIPTION SPF 15 ANTI-AGING FOUNDATION OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. OCTINOXATE; TITANIUM DIOXIDE 3; 1.4 mL/100mL; mL/100mL 59427-005_c953a0ad-7e17-4c66-8d70-973bbae82d96 59427-005 HUMAN OTC DRUG SUPER SPOT REMOVER ACNE TREATMENT SALICYLIC ACID GEL TOPICAL 20120401 OTC MONOGRAPH FINAL part333D ORIGINS NATURAL RESOURCES INC. SALICYLIC ACID 2 mL/100mL 59427-006_1b0d4e1d-1243-45ab-8260-06d43c345a19 59427-006 HUMAN OTC DRUG PLANTSCRIPTION ANTI-AGING BROAD SPECTRUM SPF 25 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE .02; .05; .075; .05; .03 g/mL; g/mL; g/mL; g/mL; g/mL 59427-007_545830bf-5a00-497b-82a0-2a72c5cc413b 59427-007 HUMAN OTC DRUG PLANTSCRIPTION ANTI AGING OIL FREE BROAD SPECTRUM SPF 25 AVOBENZONE, OCTISALATE, and OCTOCRYLENE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. AVOBENZONE; OCTISALATE; OCTOCRYLENE .0303; .0505; .02727 g/mL; g/mL; g/mL 59427-008_84eec122-cf3a-41b0-ac2b-97629942a991 59427-008 HUMAN OTC DRUG BRIGHTER BY NATURE SPF 35 SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM HOMOSALATE, OCTISALATE, AVOBENZONE, and OCTOCRYLENE CREAM TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .02988; .0498; .0498; .02689 g/mL; g/mL; g/mL; g/mL 59427-009_618db662-ea3a-4732-b3b3-d69966feb475 59427-009 HUMAN OTC DRUG BRIGHTER BY NATURE SPF 30 CORRECTING MAKEUP BROAD SPECTRUM OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 1; 3 g/100g; g/100g; g/100g 59427-110_2b3375e9-a9fa-494a-b5c8-3b57e5d13646 59427-110 HUMAN OTC DRUG SPOT REMOVER ACNE TREATMENT PADS SALICYLIC ACID LIQUID TOPICAL 20110401 OTC MONOGRAPH FINAL part333D ORIGINS NATURAL RESOURCES INC. SALICYLIC ACID .009506 g/100mL 59427-111_82cf3063-6514-40d9-a896-5efd90773eaa 59427-111 HUMAN OTC DRUG SMARTY PLANTS CC SKIN COMPLEXION CORRECTOR BROAD SPECTRUM SPF 20 OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. OCTINOXATE; OCTISALATE; OXYBENZONE .079875; .0426; .03621 g/100mL; g/100mL; g/100mL 59427-112_bd1989f1-e4fc-4891-8a96-08f0b5826396 59427-112 HUMAN OTC DRUG Dr. Andrew Weil for Origins MEGA-BRIGHT SPF 30 SKIN TONE CORRECTING OIL FREE MOISTURIZER BROAD SPECTRUM SPF 30 HOMOSALATE, OCTISALATE, AVOBENZONE, and OCTOCRYLENE CREAM TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .02988; .0498; .0498; .02689 g/mL; g/mL; g/mL; g/mL 59427-575_ff21882b-d525-4eeb-a88c-4c8c4d77fde2 59427-575 HUMAN OTC DRUG COVER YOUR MOUTH SPF 8 LIP PROTECTOR TITANIUM DIOXIDE LIPSTICK TOPICAL 19990401 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. TITANIUM DIOXIDE 1.8 g/100g 59427-701_1e451fa0-55d4-4010-9913-ea94e4ea0e68 59427-701 HUMAN OTC DRUG YOUTHTOPIA SKIN FIRMING FOUNDATION SPF 15 ZINC OXIDE, TITANIUM DIOXIDE LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC TITANIUM DIOXIDE; ZINC OXIDE 2.9; 3 mL/100mL; mL/100mL 59427-702_6ca8b040-803b-48ae-b867-f5b18fbb8a58 59427-702 HUMAN OTC DRUG A PERFECT WORLD SPF 25 AGE DEFENSE MOISTURIZER WITH WHITE TEA octisalate, avobenzone, octocrylene LOTION TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 2.7 mL/100mL; mL/100mL; mL/100mL 59427-703_18948dd7-280e-4a00-9ab3-b52777800079 59427-703 HUMAN OTC DRUG BRIGHTER BY NATURE SPF 35 SKIN TONE CORRECTING MOISTURIZER HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 2.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 59427-704_afa6e232-5968-4298-b92d-8b3207e072ad 59427-704 HUMAN OTC DRUG BRIGHTER BY NATURE SPF 30 SKIN TONE CORRECTING MAKEUP OCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENE POWDER TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 1; 3 g/100g; g/100g; g/100g 59427-705_1f0b4411-e82b-49d6-af9c-8f04f9bde37a 59427-705 HUMAN OTC DRUG VITAZING ENERGY BOOSTING MOISTURIZER SPF 15 AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 2.7 mL/100mL; mL/100mL; mL/100mL 59427-706_55df77bb-d733-4a05-bae4-cc25656d5772 59427-706 HUMAN OTC DRUG A PERFECT WORLD SPF 35 UV BROAD SPECTRUM FACE PROTECTOR homosalate, octisalate, avobenzone, octocrylene LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 2.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 59427-728_196e19b5-ae01-44cd-817c-da1c28735d60 59427-728 HUMAN OTC DRUG RAIN AND SHINE LIPTINT WITH SPF 10 SUNSCREEN OCTINOXATE LIPSTICK TOPICAL 20010901 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC OCTINOXATE 3.5 g/100g 59427-761_9f603ab9-c46c-4600-ae58-808fe6d6d6bb 59427-761 HUMAN OTC DRUG NUDE AND IMPROVED BARE FACE MAKEUP SPF 15 TITANIUM DIOXIDE LOTION TOPICAL 20020101 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. TITANIUM DIOXIDE 7.6 mL/100mL 59427-783_92c44776-4b81-4c4f-b5f5-6c3ef790595a 59427-783 HUMAN OTC DRUG HAVE A NICE DAY SUPER CHARGED SPF 15 octinoxate and titanium dioxide CREAM TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. OCTINOXATE; TITANIUM DIOXIDE 7.5; 1 mL/100mL; mL/100mL 59428-000_b84ee356-8337-407a-840f-b7ad3627b4f8 59428-000 HUMAN OTC DRUG Quadrydern Hydrocortisone CREAM TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Productos Zapotol Corp HYDROCORTISONE 10 mg/g 59428-135_063e3d25-58c4-43fa-953e-721ee31a40b8 59428-135 HUMAN OTC DRUG Zapotol Bacitracin Bacitracin CREAM TOPICAL 20140806 OTC MONOGRAPH FINAL part333B Zapatol Corp. BACITRACIN 500 [USP'U]/g 59428-359_9964de23-951e-4037-b81a-f5f03f9d0efe 59428-359 HUMAN OTC DRUG Zapotol Clotrimazole Clotrimazol CREAM TOPICAL 20120807 OTC MONOGRAPH FINAL part333C Zapotol Corp. CLOTRIMAZOLE 10 mg/100g 59428-720_cafa0cca-fe0d-440b-ac28-c0d5c6cb986b 59428-720 HUMAN OTC DRUG Multi-Symptom Relief Cold and Flu Multi-Symptom Relief Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140331 OTC MONOGRAPH FINAL part341 Productos Zapotol Corp. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 59430-101_ddd6f377-f7dd-445f-8604-4adef24f7ebd 59430-101 HUMAN OTC DRUG Nose clove AEROSOL NASAL 20130927 UNAPPROVED DRUG OTHER US EXCY-LINE INC. CLOVE .75 mg/100mL 59434-001_503ef007-a5ac-4abc-90b1-b13bd0a05d08 59434-001 HUMAN OTC DRUG Ala-Septic Salicyclic Acid CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part358H Ala-Septic Pharmaceutical Research LLC SALICYLIC ACID 2 g/100g 59448-100_f7f8898d-88a4-4efd-806e-2ba5f0d692b1 59448-100 HUMAN OTC DRUG NewYork-Presbyterian Amenity Sodium Monofluorophospate KIT 20130701 OTC MONOGRAPH FINAL part355 Anatomy Supply Partners, LLc 59450-034_4eb334a6-f4f8-4a27-9889-5840a523bb54 59450-034 HUMAN OTC DRUG TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sulfate OINTMENT TOPICAL 20030101 OTC MONOGRAPH FINAL part333B The Kroger Co. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 59450-100_68443045-9212-4f30-841e-61906ccec922 59450-100 HUMAN OTC DRUG Kroger Waterless Hand Sanitizer With Aloe With Moisturizers And Vitamin E ALCOHOL GEL TOPICAL 20091210 OTC MONOGRAPH NOT FINAL part333 The Kroger Co. ALCOHOL 62 mL/100mL 59450-200_8f44fece-a368-4a2e-b825-b3d52e991a2f 59450-200 HUMAN OTC DRUG Kroger Waterless Hand Sanitizer Citrus Scent With Moisturizers And Vitamin E ALCOHOL GEL TOPICAL 20091210 OTC MONOGRAPH NOT FINAL part333 The Kroger Co. ALCOHOL 62 mL/100mL 59450-223_3bce4f40-87f4-4f61-b8c9-daac3f956693 59450-223 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH ALOE ETHYL ALCOHOL GEL TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 THE KROGER CO ALCOHOL 62 mL/100mL 59450-231_7ddd1261-83ab-45be-aff9-d7fd5e0e1ae8 59450-231 HUMAN OTC DRUG WATERLESS HAND SANITIZER CITRUS SCENT ETHYL ALCOHOL GEL TOPICAL 20110620 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY ALCOHOL 62 mL/100mL 59450-231_d34ac523-8ce0-4a52-8d71-51edf78c91f1 59450-231 HUMAN OTC DRUG WATERLESS HAND SANITIZER CITRUS SCENT ETHYL ALCOHOL GEL TOPICAL 20110620 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY ALCOHOL 62 mL/100mL 59450-310_c0cc84cb-0d42-48f2-b019-312faec6db6c 59450-310 HUMAN OTC DRUG SKIN CARE LOTION EXTRA STRENGTH DIMETHICONE LOTION TOPICAL 20100625 OTC MONOGRAPH FINAL part347 THE KROGER CO DIMETHICONE 1 mL/100mL 59450-315_764b7c7d-32ed-4115-8aae-589869dea072 59450-315 HUMAN OTC DRUG SKIN CARE EXTRA STRENGTH DIMETHICONE LOTION TOPICAL 20100625 OTC MONOGRAPH FINAL part347 THE KROGER CO DIMETHICONE 1 mL/100mL 59450-823_268d8196-4b85-4382-8f93-cf126debb6a7 59450-823 HUMAN OTC DRUG Triple Antibiotic Plus Maximum Strength bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hcl OINTMENT TOPICAL 20080701 OTC MONOGRAPH FINAL part333B The Kroger Co. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 59460-0001_09f2249e-d76a-4bc3-a0fa-ac5270a24a88 59460-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19950101 UNAPPROVED MEDICAL GAS Detroit Oxygen & Medical Equipment Co. OXYGEN 99 L/100L 59465-210_186aadd3-2cb6-4de4-99b1-2371613e248d 59465-210 HUMAN OTC DRUG ThyroShield Potassium Iodide SOLUTION ORAL 20140901 ANDA ANDA077218 Arco Pharmaceuticals LLC POTASSIUM IODIDE 65 mg/mL 59467-318_8efd6a04-de76-4d32-9f27-db532c920f22 59467-318 HUMAN PRESCRIPTION DRUG MITIGARE Colchicine CAPSULE ORAL 20141001 NDA NDA204820 Hikma Americas, Inc. COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 59469-038_8dcbe3c2-6c93-4ae0-bd21-7dc47fdb53b9 59469-038 HUMAN OTC DRUG Zellulisan horse chestnut, arnica montana, betula pendula leaf, hedera helix flowering twig, ledum palustre twig, melilotus officinalis top, toxicodendron pubescens leaf, and sulfur OINTMENT TOPICAL 20110220 UNAPPROVED HOMEOPATHIC Pekana-Naturheilmittel GmbH ARNICA MONTANA; BETULA PENDULA LEAF; HEDERA HELIX FLOWERING TWIG; HORSE CHESTNUT; LEDUM PALUSTRE TWIG; MELILOTUS OFFICINALIS TOP; SULFUR; TOXICODENDRON PUBESCENS LEAF 8; 8; 6; 4; 3; 4; 15; 8 [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g 59469-170_122461b5-58c2-45eb-89e3-74d64044eb72 59469-170 HUMAN OTC DRUG Inflamyar arnica montana, bellis perennis, bryonia cretica subsp. dioica root, guaiacum officinale resin, ledum palustre twig, toxicodendron pubescens leaf, ruta graveolens flowering top, and viscum album fruit OINTMENT TOPICAL 20101201 UNAPPROVED HOMEOPATHIC Pekana-Naturheilmittel GmbH ARNICA MONTANA; BELLIS PERENNIS; BRYONIA CRETICA SUBSP. DIOICA ROOT; GUAIACUM OFFICINALE RESIN; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUIT 12; 8; 4; 4; 4; 6; 12; 4 [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g 59469-171_3d5ddd4c-e93d-4d55-bfa2-715188607c2f 59469-171 HUMAN OTC DRUG Opsonat nitric acid, sulfuric acid, gratiola officinalis, goldenseal, lachesis muta venom, lytta vesicatoria, bellis perennis, and glechoma hederacea LIQUID ORAL 20101201 UNAPPROVED HOMEOPATHIC Pekana-Naturheilmittel GmbH BELLIS PERENNIS; GLECHOMA HEDERACEA; GOLDENSEAL; GRATIOLA OFFICINALIS; LACHESIS MUTA VENOM; LYTTA VESICATORIA; NITRIC ACID; SULFURIC ACID 1; 1; 4; 4; 7; 4; 4; 4 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 59469-172_687b3037-cd87-493c-8d1a-398c8265c74e 59469-172 HUMAN OTC DRUG Inflamyar ARNICA MONTANA, BELLIS PERENNIS, BRYONIA CRETICA SUBSP. DIOICA ROOT, GUAIACUM OFFICINALE RESIN, LEDUM PALUSTRE TWIG, RUTA GRAVEOLENS WHOLE, TOXICODENDRON PUBESCENS LEAF, and VISCUM ALBUM FRUIT PELLET ORAL 20110901 UNAPPROVED HOMEOPATHIC Pekana-Naturheilmittel GmbH ARNICA MONTANA; BELLIS PERENNIS; BRYONIA CRETICA SUBSP. DIOICA ROOT; GUAIACUM OFFICINALE RESIN; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS WHOLE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUIT 4; 4; 4; 6; 12; 4; 8; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 59470-001_3ad1138f-e6bd-474c-b6f7-097348b0ea35 59470-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130501 UNAPPROVED MEDICAL GAS Steve Gulick, Inc. OXYGEN 990 mL/L 59478-000_4dcf24e6-398d-4e5d-8307-5792c28052f0 59478-000 HUMAN OTC DRUG KeVUENO Pain Relieving CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE OINTMENT TOPICAL 20130925 OTC MONOGRAPH NOT FINAL part348 Prilumar Laboratorios CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 5; 10; 13 g/100g; g/100g; g/100g 59494-1001_e40ce033-d3b5-4db8-989e-f488f0b29416 59494-1001 HUMAN OTC DRUG PAMO Kill Natural GINKGO BILOBA LEAF OIL LIQUID TOPICAL 20130708 UNAPPROVED DRUG OTHER GeoRim Pharmaceutical GINKGO BILOBA LEAF OIL 1 g/100mL 59494-2001_2631a673-772e-4a87-ae03-eb23e017bf26 59494-2001 HUMAN OTC DRUG PAMO Kill Natural TRIPTERYGIUM WILFORDII WHOLE LIQUID TOPICAL 20131007 UNAPPROVED DRUG OTHER GeoRim Pharmaceutical TRIPTERYGIUM WILFORDII WHOLE 28 g/100mL 59503-0544_e25373e9-a6c3-42ed-ab80-daf1c152f81c 59503-0544 HUMAN OTC DRUG Chemseptic CHLOROXYLENOL SOAP TOPICAL 20040330 OTC MONOGRAPH NOT FINAL part333E Rochester Midland Corporation CHLOROXYLENOL 3 mg/mL 59503-2605_321856a7-35ff-4928-a964-6e79651a2414 59503-2605 HUMAN OTC DRUG Hand San ALCOHOL LIQUID TOPICAL 20030503 OTC MONOGRAPH NOT FINAL part333 Rochester Midland Corporation ALCOHOL .7 mL/mL 59503-6576_869a1b7d-b5ee-489a-9286-fc788279fe91 59503-6576 HUMAN OTC DRUG Antibac Foam Wash TRICLOSAN SOAP TOPICAL 20110927 OTC MONOGRAPH NOT FINAL part333E Rochester Midland Corporation TRICLOSAN 3 mg/mL 59503-6585_bf881030-a909-43ca-9656-6a756ccb2e51 59503-6585 HUMAN OTC DRUG Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part333E Rochester Midland Corporation ALCOHOL .62 mL/mL 59528-0317_7231d9fa-3a3f-449a-9b75-81f864fa7504 59528-0317 HUMAN PRESCRIPTION DRUG NephPlex Rx multi vitamin/mineral supplement with ascorbic acid, niacin, pyridoxine, pantothenic acid, folic acid, riboflavin, thiamin, biotin, cobalamin and zinc. TABLET, COATED ORAL 19950701 UNAPPROVED DRUG OTHER Nephro-Tech, Inc. ASCORBIC ACID; BIOTIN; COBALAMIN; FOLIC ACID; NIACINAMIDE; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE; ZINC OXIDE 60; .3; .006; 1; 20; 10; 10; 1.7; 1.5; 12.5 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 59528-0416_333a96c8-e217-48d0-ad35-1a561f8f33e6 59528-0416 HUMAN PRESCRIPTION DRUG MagneBind 400 Rx vitamin/mineral supplement with magnesium carbonate, calcium carbonate and folic acid TABLET, FILM COATED ORAL 19991018 UNAPPROVED DRUG OTHER Nephro-Tech, Inc. CALCIUM CARBONATE; FOLIC ACID; MAGNESIUM CARBONATE 80; 1; 115 mg/1; mg/1; mg/1 59528-1988_c655464c-57e1-4a14-b085-47fe646c3904 59528-1988 HUMAN PRESCRIPTION DRUG Vital-D Rx multi vitamin/mineral supplement containing vitamin C, vitamin D, vitamin E, thiamin, riboflavin, niacin, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, selenium and zinc TABLET, COATED ORAL 20071101 UNAPPROVED DRUG OTHER Nephro-Tech, Inc. ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; COBALAMIN; FOLIC ACID; NIACINAMIDE; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENOMETHIONINE; THIAMINE; TOCOPHEROL; ZINC OXIDE 60; 300; 2000; 6; 1; 20; 10; 10; 1.7; 70; 1.5; 35; 12.5 mg/1; ug/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; [iU]/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 59528-4456_a1d573c0-3355-4eb0-8447-b520052b666c 59528-4456 HUMAN PRESCRIPTION DRUG Nephron FA mineral/vitamin supplement TABLET, COATED ORAL 19921101 UNAPPROVED DRUG OTHER Nephro-Tech, Inc. ASCORBIC ACID; BIOTIN; COBALAMIN; FOLIC ACID; IRON; NIACINAMIDE; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE 40; .3; .006; 1; 66; 20; 10; 10; 1.7; 1.5 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 59532-001_db430c4e-6e61-4bf3-b21d-c6f97236834e 59532-001 HUMAN OTC DRUG SHEZA GUSL FIRMING MASK PACK Niacinamide, Adenosine CREAM TOPICAL 20130809 UNAPPROVED DRUG OTHER PISATAP ADENOSINE; NIACINAMIDE .02; 1 g/50g; g/50g 59533-1001_5473b47b-6f4a-4d25-ab72-107d8388f7dd 59533-1001 HUMAN OTC DRUG CHRIOLOGY Relax Up MENTHOL GEL TOPICAL 20130730 UNAPPROVED DRUG OTHER Chrio Korea Co., Ltd MENTHOL .1 mg/mL 59533-2001_343642a0-ae18-4580-9033-b3b6bdbc11df 59533-2001 HUMAN OTC DRUG CHRIOLOGY Shiatsu Magic Point COTTON FIBER PATCH TOPICAL 20130730 UNAPPROVED DRUG OTHER Chrio Korea Co., Ltd COTTON FIBER 1 g/1 59534-001_283c6115-a140-4111-af4d-fdd7a58d724d 59534-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19920502 UNAPPROVED MEDICAL GAS Richmond Oxygen Company Inc. OXYGEN 99 L/100L 59534-002_42292a6c-92f0-4bed-b756-0aa6659ff425 59534-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19920502 UNAPPROVED MEDICAL GAS Richmond Oxygen Company Inc. NITROGEN 99 L/100L 59535-0011_239ae403-232a-4b4e-9659-48de110187f7 59535-0011 HUMAN OTC DRUG Super Aqua Facial Foam Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .16 g/mL 59535-0101_951e07d1-5c05-4774-b09a-48ed3859134f 59535-0101 HUMAN OTC DRUG PROPOLIS 39 CC ZINC OXIDE CREAM TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .0098 g/g 59535-0111_937168a5-22fb-49f9-a764-f0ad475f15c1 59535-0111 HUMAN OTC DRUG Ultra Nutrition Night Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .06 g/mL 59535-0121_0bce0ed2-4d4a-47a2-bb67-1d78f52ae1be 59535-0121 HUMAN OTC DRUG CLIV RYEOYUN SNOW WHITE Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL 59535-0131_195d5aa9-2773-41ef-8fef-324e632f4e6d 59535-0131 HUMAN OTC DRUG JEJUEN NOURISHING OPUNTIA ICE PACK Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL 59535-0141_a9f693e1-912b-4069-afbb-d103d4314613 59535-0141 HUMAN OTC DRUG DCS PORE TIGHTENING SERUM Glycerin LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 1 g/100mL 59535-0151_9da264dc-3c0f-417e-8bca-5637918e2060 59535-0151 HUMAN OTC DRUG JEJUEN LOTUS PLACENTA EYE GLYCERIN LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 3 g/100mL 59535-0201_6ccb1b45-8fcc-4b1b-b72f-ab1d2798c5ad 59535-0201 HUMAN OTC DRUG ACTIVE RESURGENCE SERUM GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 mg/mL 59535-0301_56cc5a0a-812d-4897-ad87-5b2e53843733 59535-0301 HUMAN OTC DRUG COLLAGEN RESURGENCE STEMCELL BB ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .0686 mg/g 59535-0401_4f80042c-6dcd-4750-a39a-35c0f8fd9fe2 59535-0401 HUMAN OTC DRUG MAX HYALURONIC STEMCELL SLEEPING PACK GLYCERIN CREAM TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .02 g/mL 59535-0601_e173b195-9d36-432a-ac26-482e8714f34c 59535-0601 HUMAN OTC DRUG Vitalizer Laser Aid BB Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/g 59535-0701_13b3cdf9-1da0-4559-95c9-3710c582e750 59535-0701 HUMAN OTC DRUG Blemish Toner Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .02 g/mL 59535-0801_dcd8acb4-7d7e-42a8-8031-0ab055cbb795 59535-0801 HUMAN OTC DRUG Jasmine Eco Mist Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .01 g/mL 59535-0901_0c2ead9e-dffc-449a-9fb5-ec7b1a1135cd 59535-0901 HUMAN OTC DRUG Pore Tightening Serum Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05 g/mL 59535-1001_32549d52-3497-4283-82b2-77f4d7646f1a 59535-1001 HUMAN OTC DRUG GOLD CAVIAR BB Zinc oxide CREAM TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .07 g/g 59535-1011_4f2ef720-be2b-4f6e-abc2-4dfd6d2192d9 59535-1011 HUMAN OTC DRUG Super Aqua Toner Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 g/mL 59535-1021_6b11430e-8f06-485a-a1ef-38f5e7c7e8a5 59535-1021 HUMAN OTC DRUG Super Aqua Ampoule Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .06 g/mL 59535-1031_21e976f5-0d89-41d0-87b1-7980acb81f03 59535-1031 HUMAN OTC DRUG Super Aqua Day Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 g/mL 59535-1041_0db2990d-545c-4d8e-9911-592a0d4f25d3 59535-1041 HUMAN OTC DRUG Super Aqua Night Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .06 g/mL 59535-1051_c1c7abf0-b87d-46a7-86bb-0e4025911c59 59535-1051 HUMAN OTC DRUG Super Aqua Eye Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/mL 59535-1071_2a50c24e-1a3d-4f00-9259-9693b1b8acdb 59535-1071 HUMAN OTC DRUG Ultra Nutrition Toner Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/mL 59535-1081_8277aa7d-adee-493f-b895-3270f8dcff12 59535-1081 HUMAN OTC DRUG Ultra Nutrition Ampoule Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 g/mL 59535-1091_b7d99f12-5848-42bb-b272-4d23bb633a0a 59535-1091 HUMAN OTC DRUG Ultra Nutrition Day Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 g/mL 59535-1101_06f774af-85e5-4195-9db2-2e14eca8eb35 59535-1101 HUMAN OTC DRUG Medskin Cleansing POLYSORBATE 20 OIL TOPICAL 20130801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. POLYSORBATE 20 .21 mg/mL 59535-1111_d45266ad-86ce-4fd9-b1bd-6260d794b591 59535-1111 HUMAN OTC DRUG Ultra Nutrition Eye Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/mL 59535-1131_1ffba80e-2be0-4d95-b83f-8282256f80e5 59535-1131 HUMAN OTC DRUG Intensive Vital Ampoule Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .02 g/mL 59535-1141_683b37f7-e125-4baf-9c78-588d08a082bb 59535-1141 HUMAN OTC DRUG BRTC ANTI BLEMISH COMPLEX Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL 59535-1151_26e23ee2-4aaa-4841-95ea-0288e82184d7 59535-1151 HUMAN OTC DRUG BRTC BLUE PHYTO COMPLEX Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL 59535-1161_00543a73-f374-4a0e-b9db-2d78ab93a170 59535-1161 HUMAN OTC DRUG BRTC PURPLE VIGOR COMPLEX Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL 59535-1171_db439fd0-adb8-4552-9e71-4ba3a9d33f54 59535-1171 HUMAN OTC DRUG BRTC TANNIN PORE COMPLEX Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL 59535-1181_6915bdc5-226c-457f-91a5-b3a3eaa481ff 59535-1181 HUMAN OTC DRUG BRTC WHITE PHYTO COMPLEX Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL 59535-1191_dca8b2e8-9fdb-484f-bf77-5c8052edc70c 59535-1191 HUMAN OTC DRUG CLIV RYEOYUN SNOW WHITE AMPOULE Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL 59535-1201_66aacc1f-141e-478f-9dd7-001b935cb38b 59535-1201 HUMAN OTC DRUG ULTRA HYDRO FACIAL FOAM GLYCERIN LIQUID TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .015 g/mL 59535-1211_bfa71a97-55fd-4aee-bce6-7532730c0391 59535-1211 HUMAN OTC DRUG CLIV RYEOYUN SNOW WHITE Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL 59535-1221_ca7f6e30-33d2-4423-93d0-269310a47ab4 59535-1221 HUMAN OTC DRUG JEJUEN LIGHTENING BLUEBERRY ICE MASK Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 3 g/100g 59535-1231_841cca91-7331-4d2f-b736-25ecbe689d07 59535-1231 HUMAN OTC DRUG JEJUEN CALMING ALOE ICE PACK Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL 59535-1241_cee5bcfe-54a7-4a1b-8e5b-7d1b1bb7a7d1 59535-1241 HUMAN OTC DRUG JEJUEN CALMING ALOE SHEET MASK Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100g 59535-1251_7535ce13-cc37-4d4f-80be-b20a4e73109c 59535-1251 HUMAN OTC DRUG JEJUEN CALMING BROCCOLI ICE MASK Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 3 g/100g 59535-1261_e6706b39-e378-4566-bf7a-1088658c61ed 59535-1261 HUMAN OTC DRUG JEJUEN LIGHTENING HANRABONG ICE PACK Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL 59535-1271_ea93876f-9088-4e6d-8f06-64ec9811728a 59535-1271 HUMAN OTC DRUG JEJUEN LIGHTENING HANRABONG SHEET MASK Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100g 59535-1281_320396e0-cf7f-411e-b900-988bb9657870 59535-1281 HUMAN OTC DRUG JEJUEN NO SEBUM LOTUS ICE MASK Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 3 g/100g 59535-1291_9ae69d22-fcb2-479a-b740-b14baebe2aa6 59535-1291 HUMAN OTC DRUG JEJUEN NOURISHING BEET ICE MASK Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 3 g/100g 59535-1301_7ca5b273-2407-4689-bb7e-fb4f1a696944 59535-1301 HUMAN OTC DRUG REVITALIZING FACIAL FOAM GLYCERIN LIQUID TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .015 g/mL 59535-1311_7ebee479-5283-4c87-989f-9387a093d1fa 59535-1311 HUMAN OTC DRUG JEJUEN NOURISHING OPUNTIA SHEET MASK Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100g 59535-1321_e84006ed-c40e-4121-b4ae-c89ad8dcd8cf 59535-1321 HUMAN OTC DRUG JEJUEN PORE TIGHTENING PEPPERMINT ICE PACK Glycerin CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL 59535-1331_8c093dfb-83af-4a45-be26-84d7c4f5bca3 59535-1331 HUMAN OTC DRUG JEJUEN PORE TIGHTENING PEPPERMINT SHEET MASK Glycerin LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100g 59535-1341_a80d5989-9c38-4c32-bfec-1749c6471085 59535-1341 HUMAN OTC DRUG JEJUEN WATERFUL APPLEMANGO ICE PACK Glycerin CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL 59535-1351_76497a5e-bddf-4f2a-9613-a4f769d48e0c 59535-1351 HUMAN OTC DRUG JEJUEN WATERFUL APPLEMANGO SHEET MASK Glycerin LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100g 59535-1361_da9c6da8-a05a-4457-8019-daf9dcfdd27a 59535-1361 HUMAN OTC DRUG JEJUEN WATERFUL PEANUT ICE MASK Glycerin LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100g 59535-1371_256abffa-0ca3-4260-8dd9-a8eda2530aff 59535-1371 HUMAN OTC DRUG BRTC VITALIZER SLEEPING PACK Glycerin CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 8 g/100mL 59535-1381_9bad9f5c-950c-47b6-9a1d-5b3b5ea49e33 59535-1381 HUMAN OTC DRUG DCS PORE REFINING Glycerin CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 1 g/100mL 59535-1391_01817052-81ab-437e-85ad-b88d5dff6b2a 59535-1391 HUMAN OTC DRUG DSC PORE CLEANSING Glycerin PATCH TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 1 g/100g 59535-1401_eb15dca5-3cfd-4e9f-9085-b7b089bbd017 59535-1401 HUMAN OTC DRUG WHITENING LEMON PEEL CITRIC ACID MONOHYDRATE LIQUID TOPICAL 20130831 OTC MONOGRAPH FINAL part331 AMI Cosmetic Co.,Ltd. CITRIC ACID MONOHYDRATE .007 g/mL 59535-1411_caf12112-3017-4f2c-9496-3566f8e053c0 59535-1411 HUMAN OTC DRUG DCS PORE HEATING CLEANSING Glycerin GEL TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 91.16098 g/100mL 59535-1421_65cbad17-afd4-40a4-a81f-8a1beffd611d 59535-1421 HUMAN OTC DRUG DCS BLEMISH CARE FOAM CLEANSER Glycerin LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 20.009 g/100mL 59535-1431_cdb807f0-2c66-443b-b7bd-3195b77e4f66 59535-1431 HUMAN OTC DRUG DCS BLEMISH CARE Glycerin CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 15.585 g/100mL 59535-1441_a633a6a4-dddd-4d0d-b8ed-53a675458146 59535-1441 HUMAN OTC DRUG DCS BLEMISH CARE AMPOULE Glycerin LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 11.3 g/100mL 59535-1451_67d27474-b194-4d83-a2d7-d1631b5611fa 59535-1451 HUMAN OTC DRUG DCS INTENSIVE VITAL MASK Glycerin LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100g 59535-1461_e50d353d-2a90-471e-8cd7-c26764d52058 59535-1461 HUMAN OTC DRUG DCS INTENSIVE VITAL Glycerin CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 11.0005 g/100mL 59535-1471_a375f4b4-9fd8-429f-97fa-ca43ce65bd08 59535-1471 HUMAN OTC DRUG DCS INTENSIVE VITAL TONER Glycerin LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 10.05 g/100mL 59535-1481_23b201bb-badd-4b24-be01-9bc0dec2d850 59535-1481 HUMAN OTC DRUG JEJUEN LOTUS BUBBLE FOAM CLEANSER Glycerin LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL 59535-1491_eec4260b-9775-42b4-a162-acb7c38280ab 59535-1491 HUMAN OTC DRUG JEJUEN PLACENTA BOOSTING AMPOULE DIMETHICONE LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. DIMETHICONE 1.5 g/100mL 59535-1501_69b75e1d-1774-4a60-a3c7-99c02efbd431 59535-1501 HUMAN OTC DRUG HERBAL STEMCELL AHA PEEL LACTIC ACID LIQUID TOPICAL 20130801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. LACTIC ACID .01 mg/mL 59535-1601_28cccdf1-0d40-48fc-9f50-28681ca00d20 59535-1601 HUMAN OTC DRUG ACTIVE RESURGENCE TONER GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 mg/mL 59535-1701_9dfd3690-d585-4654-858d-1aeffe5d1550 59535-1701 HUMAN OTC DRUG ULTRA HYDRA TONER GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .02 mg/mL 59535-1801_96923229-dc8e-4a76-a77d-fbaa303c2055 59535-1801 HUMAN OTC DRUG REVITALIZING C TONER GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 mg/mL 59535-1901_8390faca-3bcf-448c-bbad-c39f75bed013 59535-1901 HUMAN OTC DRUG ACTIVE RESURGENCE EYE GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .07 mg/mL 59535-2001_1540b958-4006-4529-a4cd-03445faf75fb 59535-2001 HUMAN OTC DRUG JASMINE WATER BB Zinc oxide CREAM TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .0192 g/g 59535-2101_13944a2f-9cee-46f7-b103-63233db871f6 59535-2101 HUMAN OTC DRUG ULTRA HYDRA SERUM GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .1 g/mL 59535-2201_89b25740-e113-48d4-a35b-c1c0e43b5737 59535-2201 HUMAN OTC DRUG REVITALIZING C SERUM GLYCERIN LIQUID TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05 g/mL 59535-2301_537bec62-fa94-4191-80bb-cf371d9dacfd 59535-2301 HUMAN OTC DRUG COLLAGEN RESURGENCE LASER AMPOULE GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 mg/mL 59535-2401_ff9337dc-e6f1-4c02-88cd-794ce57afb58 59535-2401 HUMAN OTC DRUG REVITALIZING C I2PL CORRECTOR AMPOULE GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 mg/mL 59535-2501_c5518bfa-5f70-474d-a72d-ba8018fe6901 59535-2501 HUMAN OTC DRUG SEAWEED MEDICLEAR HEALER AMPOULE GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .018 mg/mL 59535-2601_6cf48362-1a3d-4335-b49b-795a9a9a19b6 59535-2601 HUMAN OTC DRUG ACTIVE RESURGENCE GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 g/g 59535-2701_d1c8cb89-1dd6-40d0-87d1-cb94d0496ad3 59535-2701 HUMAN OTC DRUG ULTRA HYDRA GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .1 g/g 59535-2801_500ac9c3-f77b-4ac8-be85-2e9663cfde2e 59535-2801 HUMAN OTC DRUG REVITALIZING C GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .1 g/g 59535-2901_51c6a2e4-fbf3-4df7-ac2c-f79c3a2de6e8 59535-2901 HUMAN OTC DRUG MAX HYALURONIC UV STEMCELL SUN BLOCK GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .00001 mg/mL 59535-3001_40541278-8e3c-4e97-94fb-c9010077ddb2 59535-3001 HUMAN OTC DRUG JASMINE 3D WATERFUL 3D C.C Zinc oxide CREAM TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .07 g/g 59535-3011_bdb98f1e-ce10-46e0-913c-7c7b67e4ef7a 59535-3011 HUMAN OTC DRUG JASMINE 3D WATERFUL CC Zinc oxide CREAM TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .07 g/g 59535-3101_ca38b6a4-a0b0-4f87-9f7a-e09e1259cc12 59535-3101 HUMAN OTC DRUG REVITALIZING C I2PL STEMCELL BB ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .0686 mg/g 59535-3201_71357bb9-1b25-4997-a03d-1b8aa8e58ea1 59535-3201 HUMAN OTC DRUG SEAWEED MEDICLEAR STEMCELL BB GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .000001 g/g 59535-3301_6bf0a4f6-fdd4-4a63-b7a4-48d834bcab01 59535-3301 HUMAN OTC DRUG MEDICLEAR DUAL SPOT DAY and NIGHT GLYCERIN LIQUID TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05 g/mL 59535-3311_a05fbb7b-4963-4f16-a506-6315b217e01a 59535-3311 HUMAN OTC DRUG MEDICLEAR DUAL SPOT DAY and NIGHT GLYCERIN LIQUID TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05 g/mL 59535-3401_60b2b1ae-3f80-4b4f-b492-d62ce529bca9 59535-3401 HUMAN OTC DRUG GOLDEN BALL HEALER GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 mg/mL 59535-3501_224efa75-6c0e-45c9-8d99-607c4e0cd8e6 59535-3501 HUMAN OTC DRUG SNAIL RECOVER HEALER GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .07 mg/mL 59535-3601_c80cf794-b449-4bff-8071-4e950b7aefaf 59535-3601 HUMAN OTC DRUG BLACK HEAD REMOVER PANTHENOL LIQUID TOPICAL 20130801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. PANTHENOL .002 mg/mL 59535-3701_4d4f182f-20f4-4088-a0fd-bd4cf46c96c2 59535-3701 HUMAN OTC DRUG MULTI ACTION POWER GLYCERIN EMULSION TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .075205 g/mL 59535-3801_87e3c031-0437-4256-8fef-b174a4ce15c5 59535-3801 HUMAN OTC DRUG MULTI ACTION BALANCING TONER GLYCERIN LIQUID TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05205 g/mL 59535-3901_e511ca99-7f90-4499-a136-ff4d10bc31a8 59535-3901 HUMAN OTC DRUG MAX HYALURONIC STEMCELL EYE GLYCERIN CREAM TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .00007 g/mL 59535-4001_d2d214ae-8940-420a-884b-e0da0cd54a83 59535-4001 HUMAN OTC DRUG BRIGHT EYE VITALIZER DIMETHICONE STICK TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. DIMETHICONE .01 g/g 59535-4101_1703580f-3cdf-46f5-b3a3-b8a452926ddc 59535-4101 HUMAN OTC DRUG SUPREME 1ST ESSENCE ALLANTOIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .002 mg/mL 59535-4201_cdfec46a-5e01-4b98-aa45-ab18906455a3 59535-4201 HUMAN OTC DRUG V SHAPING AMPOULE GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .01 mg/mL 59535-4301_c073b801-9a36-4131-aac7-fd66efb52e8d 59535-4301 HUMAN OTC DRUG COLLAGEN RESURGENCE MASK GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .01 g/g 59535-4311_3da48f12-bf12-4461-a34d-c58f477070ca 59535-4311 HUMAN OTC DRUG COLLAGEN RESURGENCE MASK GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 g/g 59535-4401_cdc5f742-16f9-4f70-9d24-7d853d163c9b 59535-4401 HUMAN OTC DRUG MAX HYALURONIC MASK GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .01 g/g 59535-4411_00de3be6-69d4-4be6-99cb-58958c31394a 59535-4411 HUMAN OTC DRUG MAX HYALURONIC MASK GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/g 59535-4501_faf9d1ca-33e6-4268-8f19-2330878b2cd0 59535-4501 HUMAN OTC DRUG REVITALIZING C I2PL MASK GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .01 g/g 59535-4511_9f20ca0f-ec1e-4b65-84b8-fffe2b9306c7 59535-4511 HUMAN OTC DRUG REVITALIZING C I2PL MASK GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .100005 g/g 59535-4601_2204cb8d-26e2-4c96-acef-cb10f34b9394 59535-4601 HUMAN OTC DRUG SEAWEED MEDICLEAR MASK GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .01 g/g 59535-4611_c32865db-3423-4f66-8cf1-7a9ab5919af5 59535-4611 HUMAN OTC DRUG SEAWEED MEDICLEAR MASK GLYCERIN LIQUID TOPICAL 20130907 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/g 59535-4701_f3890438-e7c6-41a4-9c0a-9e2c92d355ac 59535-4701 HUMAN OTC DRUG CLIV Barrier Power Ampoule GLYCERIN LIQUID TOPICAL 20140306 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 g/mL 59535-4801_4f0fe89b-472d-40ba-acdb-de27b38f6481 59535-4801 HUMAN OTC DRUG CLIV Barrier Power GLYCERIN CREAM TOPICAL 20140306 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 g/mL 59535-4911_1467507a-ee16-4445-bca1-be201c16ee0f 59535-4911 HUMAN OTC DRUG CLIV Barrier Power GLYCERIN LOTION TOPICAL 20140306 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .09 g/mL 59535-5001_0496befb-f2f0-431f-b915-6f40142eb96e 59535-5001 HUMAN OTC DRUG OVERNIGHT PORE TIGHTENER DIMETHICONE GEL TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. DIMETHICONE .024 g/mL 59535-5011_350f0e3f-0393-406b-b5fe-014c5a90799c 59535-5011 HUMAN OTC DRUG CLIV Ginseng Berry Premium Ampoule GLYCERIN LIQUID TOPICAL 20140306 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/mL 59535-5101_52cce31a-67b2-46f0-87d4-ad5d4ab6069d 59535-5101 HUMAN OTC DRUG CLIV Ginseng Berry Premium GLYCERIN CREAM TOPICAL 20140306 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .0433 g/mL 59535-5201_42db4e22-f8e5-49d8-b9df-e8f9a1ae284d 59535-5201 HUMAN OTC DRUG CLIV Ginseng Berry Premium Eye GLYCERIN CREAM TOPICAL 20140306 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .0279 g/mL 59535-5301_d47da0f2-c454-4f74-a2e2-8b6ce08f19ff 59535-5301 HUMAN OTC DRUG Gold Caviar Cover Cushion Zinc oxide POWDER TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .02 g/g 59535-5401_2b10274c-4ab0-4a44-94f8-800fb1e3cb7c 59535-5401 HUMAN OTC DRUG The First Ampoule Essence Allantoin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .002 g/g 59535-5501_ed60a2e8-3521-497a-9a33-edcea860eb80 59535-5501 HUMAN OTC DRUG The First Ampoule Essence BB Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 g/g 59535-5601_22db5dcd-0856-4a0f-9114-c337bfa96aeb 59535-5601 HUMAN OTC DRUG Medi Stem Eye Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .10295 g/mL 59535-5701_f4d29336-91b8-46fe-b46c-b82091c1feeb 59535-5701 HUMAN OTC DRUG Medi Stem Collagen Ampoule Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 g/mL 59535-5801_c42f8a05-65cf-4780-8f0e-c40f8d871671 59535-5801 HUMAN OTC DRUG Medi Stem Collagen Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .02 g/mL 59535-5901_a16f28a9-5970-4799-b6ed-60578ffc5ed8 59535-5901 HUMAN OTC DRUG Medi Stem Collagen Toner Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 g/mL 59535-6001_20e6064d-ddb9-484e-8303-ae1e6b2e1ce8 59535-6001 HUMAN OTC DRUG BLEMISH RECOVER BALM DIMETHICONE CREAM TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. DIMETHICONE .015 g/mL 59535-6101_e36dcec6-e421-48ce-bf35-f3251767f85d 59535-6101 HUMAN OTC DRUG Vitalizer Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05 g/mL 59535-6201_4440f8d5-e9f4-4346-88ea-69c6ac5a56bc 59535-6201 HUMAN OTC DRUG Vitalizer Fluid Allantoin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .001 g/mL 59535-6301_4bcee347-7267-48e9-a27a-18a2feec1134 59535-6301 HUMAN OTC DRUG Vitalizer White DEXPANTHENOL LIQUID TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part347 AMI Cosmetic Co.,Ltd. DEXPANTHENOL .0005 g/mL 59535-6401_3c9604ad-5480-4683-8ba0-1169ef0a6f6b 59535-6401 HUMAN OTC DRUG Vitalizer White Glycerin GEL TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .015 g/mL 59535-6501_2e0bcad4-c291-439d-89ce-4a431941f42f 59535-6501 HUMAN OTC DRUG Vitalizer C10 Ampoule Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .001 g/mL 59535-6601_730a9477-21b1-48c7-a95a-6135312fedd4 59535-6601 HUMAN OTC DRUG Bubble Refining Cleanser Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05 g/mL 59535-6701_290d9952-5acf-4ae5-ae68-2905aa337da5 59535-6701 HUMAN OTC DRUG Blemish Serum Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05 g/mL 59535-6801_a0498c6f-8dc3-4ecc-8e68-73f65b20f16d 59535-6801 HUMAN OTC DRUG Blemish Soothing Moisturizer Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 g/mL 59535-6901_007c4576-5b4e-4c8c-9aac-10d6d2af92bf 59535-6901 HUMAN OTC DRUG Blemish Allantoin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .0005 g/mL 59535-7001_08f5eaf7-c280-48b2-95b5-027827f558ee 59535-7001 HUMAN OTC DRUG MAX HYALURONIC FORMULA AMPOULE GLYCERIN LIQUID TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 g/mL 59535-7101_3137afdf-4d20-45b3-a974-26516704f5b1 59535-7101 HUMAN OTC DRUG Blemish Potion Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05 g/mL 59535-7201_d26b16e9-32c4-45a4-acf6-78df7a5c464d 59535-7201 HUMAN OTC DRUG Aqua Rush Serum Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .1 g/mL 59535-7301_6da39c10-134c-4a25-b2fa-f3260c2a1a14 59535-7301 HUMAN OTC DRUG Aqua Rush Water Drop BB TITANIUM DIOXIDE CREAM TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part352 AMI Cosmetic Co.,Ltd. TITANIUM DIOXIDE .0934 g/g 59535-7401_c9b9a0e2-41a7-4e68-8e78-e5de46c6ea74 59535-7401 HUMAN OTC DRUG Aqua Rush Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .084 g/mL 59535-7501_3ad3193d-ee11-418d-bfad-06373d320fb1 59535-7501 HUMAN OTC DRUG Aqua Rush Fluid Allantoin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .001 g/mL 59535-7601_da2d3b69-3632-495f-952b-b674369f0cfd 59535-7601 HUMAN OTC DRUG Aqua Rush Cover Cushion Glycerin POWDER TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .0000167 g/g 59535-7701_7d0bbecc-edc1-4ffa-8fe7-291d4bac6384 59535-7701 HUMAN OTC DRUG Jasmine 3D Moist Glycerin POWDER TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .1 g/g 59535-7801_6acbdcc5-5341-4602-8f04-3a7d18e8da5a 59535-7801 HUMAN OTC DRUG Jasmine 3D Moist Pact Allantoin POWDER TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .002 g/g 59535-7901_3588538e-1c7c-4811-8d42-4187658e5c51 59535-7901 HUMAN OTC DRUG Jasmine 3D Whipping Essence Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .002 g/mL 59535-8001_c5637e58-3393-41a8-8480-d1a337df5b51 59535-8001 HUMAN OTC DRUG MAX HYALURONIC STEMCELL BB ZINC OXIDE CREAM TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .0098 g/g 59535-8101_5ab251f2-f70e-458d-b848-bf3d3f640019 59535-8101 HUMAN OTC DRUG Jasmine Water Cover Cushion Zinc oxide LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .02 g/g 59535-8201_b234b3df-73ee-430a-a45b-021ab82003c8 59535-8201 HUMAN OTC DRUG Ginseng Stemcell Mask Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 g/g 59535-8301_f38aeb8c-e73e-4496-a650-37e717ddc0cb 59535-8301 HUMAN OTC DRUG Power Aqua Balancing Toner Allantoin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .002 g/mL 59535-8401_df53dd9a-e323-455a-93fa-da7c2a025755 59535-8401 HUMAN OTC DRUG Power Defence Smart Allantoin EMULSION TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .002 g/mL 59535-8501_ac5fdfc8-8cda-482c-9450-67521dcb6073 59535-8501 HUMAN OTC DRUG Perfect Calming BB Remover Allantoin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .001 g/mL 59535-8601_849b1f26-1728-4dbf-b92f-4f328fd93347 59535-8601 HUMAN OTC DRUG Perfect Calming Serum Allantoin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .0005 g/mL 59535-8701_d7330022-eb1b-4b2a-8a76-3155a76cb541 59535-8701 HUMAN OTC DRUG Perfect Calming Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 g/mL 59535-8801_04548753-7e03-4e47-9c61-e6e1f76fade6 59535-8801 HUMAN OTC DRUG Perfect Calming Toner Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/mL 59535-8901_8931c7e6-526b-4c2f-b5a0-e3b94d526857 59535-8901 HUMAN OTC DRUG Perfect Pore Clean I DEXPANTHENOL LIQUID TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part347 AMI Cosmetic Co.,Ltd. DEXPANTHENOL .001 g/mL 59535-9001_6e65fb17-4e15-4759-b71b-ca87a1e021e3 59535-9001 HUMAN OTC DRUG PROPOLIS 90 AMPOULE ZINC OXIDE LIQUID TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .0098 g/mL 59535-9101_a9eb61ab-fde6-46a6-a055-a310e308952c 59535-9101 HUMAN OTC DRUG Whitening Repairing BB Allantoin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .0005 g/g 59535-9201_6aea9620-a389-4ec3-8ce5-4f6f139920d8 59535-9201 HUMAN OTC DRUG Whitening Repairing Cover Cushion Allantoin POWDER TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .0001 g/g 59535-9301_65fe35b6-c7ff-4e38-8235-20a0c5104cae 59535-9301 HUMAN OTC DRUG Vitamin A Velvet Mask Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .06 g/g 59535-9401_713fa36d-6493-4ec6-bbbf-18ff6f8576fb 59535-9401 HUMAN OTC DRUG Vitamin B5 Velvet Mask Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .06 g/g 59535-9501_99b21ac7-60c5-4363-b0a4-66ab42592cc5 59535-9501 HUMAN OTC DRUG Vitamin C Velvet Mask Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .06 g/g 59535-9601_5814bfb4-09d7-4969-b7a6-e06f3bfe3632 59535-9601 HUMAN OTC DRUG Vitamin E Velvet Mask Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .06 g/g 59535-9701_3ae3bc63-5a6b-45d2-86dd-65ed03ad1f98 59535-9701 HUMAN OTC DRUG Vitamin F Velvet Mask Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .06 g/g 59535-9801_5311175c-7e6c-4563-b72b-f741989cb7c8 59535-9801 HUMAN OTC DRUG Vitamin H Velvet Mask Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/g 59535-9901_1ae858e1-85c1-49f4-85e8-e8e3f67e22c2 59535-9901 HUMAN OTC DRUG Super Aqua Cleansing Oil Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/mL 59538-001_21bc578d-07c5-4466-8169-e22b76f2728d 59538-001 HUMAN OTC DRUG biokera PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20130801 OTC MONOGRAPH FINAL part358H SALERM COSMETICA PROFESIONAL, S.A. PYRITHIONE ZINC 1 g/10g 59538-002_2a74689f-cb04-4c88-ab07-b3f232692aa0 59538-002 HUMAN OTC DRUG biokera PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20130801 OTC MONOGRAPH FINAL part358H SALERM COSMETICA PROFESIONAL, S.A. PYRITHIONE ZINC .5 g/10g 59538-003_84487bf2-e15d-4b65-bf65-635e62473bf1 59538-003 HUMAN OTC DRUG biokera PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20130801 OTC MONOGRAPH FINAL part358H SALERM COSMETICA PROFESIONAL, S.A. PYRITHIONE ZINC .1 g/10g 59538-004_4db5881e-20b8-4103-89f7-35dca483847f 59538-004 HUMAN OTC DRUG biokera PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H SALERM COSMETICA PROFESIONAL, S.A. PYRITHIONE ZINC 1 g/10g 59543-1001_5cdc4584-d800-44c9-98f5-81d0342ae77d 59543-1001 HUMAN OTC DRUG WeTTrust Gold Glycerin GEL VAGINAL 20130729 OTC MONOGRAPH FINAL part346 WeTTrust Korea Co., Ltd GLYCERIN .17 g/g 59543-2001_22963d1f-6027-41bc-af47-e998fd7c0c0c 59543-2001 HUMAN OTC DRUG Inclear Glycerin GEL VAGINAL 20130729 OTC MONOGRAPH FINAL part346 WeTTrust Korea Co., Ltd GLYCERIN .04 g/g 59543-3001_57738671-4a5a-492f-8204-3733a70e38c2 59543-3001 HUMAN OTC DRUG Inclear Glycerin GEL VAGINAL 20130729 OTC MONOGRAPH FINAL part346 WeTTrust Korea Co., Ltd GLYCERIN .04 g/g 59547-210_045baa49-d22c-4ed8-8dd6-b90565eca017 59547-210 HUMAN PRESCRIPTION DRUG Glycate Glycopyrrolate TABLET ORAL 20120312 ANDA ANDA091522 Nuro Pharma, Inc. GLYCOPYRROLATE 1.5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 59555-401_5a2a436b-c816-44e6-a821-d42c9beeb46e 59555-401 HUMAN OTC DRUG I.C. Hand Sanitizer Benzalkonium Chloride AEROSOL, FOAM TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part333A R&R Lotion, Inc. BENZALKONIUM CHLORIDE 1 mg/mL 59555-601_87ba9574-fefc-42ba-a21a-c297eb721453 59555-601 HUMAN OTC DRUG I.C. Barrier Benzethonium Chloride and Dimethicone LOTION/SHAMPOO TOPICAL 20140917 OTC MONOGRAPH NOT FINAL part333A R&R Lotion, Inc. BENZETHONIUM CHLORIDE; DIMETHICONE 2; 20 mg/mL; mg/mL 59556-007_82d20232-4f22-4220-88da-8f8445d79e30 59556-007 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20130504 ANDA ANDA200770 Strides Pharma Inc HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 59556-008_82d20232-4f22-4220-88da-8f8445d79e30 59556-008 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20130504 ANDA ANDA200770 Strides Pharma Inc HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 59556-009_82d20232-4f22-4220-88da-8f8445d79e30 59556-009 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20130504 ANDA ANDA200770 Strides Pharma Inc HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 59564-251_603b96bf-ab3f-4ac2-966b-8060f1cfe745 59564-251 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20081201 ANDA ANDA076134 Innovative Manufacturing and Distribution Services, Inc. LORATADINE 10 mg/1 59567-001_8679eaaa-9637-4fb5-af98-5af021179636 59567-001 HUMAN OTC DRUG Capent Diaper Rash Zinc Oxide Lanolin OINTMENT TOPICAL 20130301 OTC MONOGRAPH FINAL part347 Laboratorios Columbia S.A. de C.V. LANOLIN; ZINC OXIDE 15.5; 25 g/100g; g/100g 59572-102_af701fa0-7df4-11e3-baa7-0800200c9a66 59572-102 HUMAN PRESCRIPTION DRUG VIDAZA azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20040705 NDA NDA050794 Celgene Corporation AZACITIDINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 59572-205_62e5a320-fb7c-11e3-a3ac-0800200c9a66 59572-205 HUMAN PRESCRIPTION DRUG Thalomid Thalidomide CAPSULE ORAL 20030620 NDA NDA020785 Celgene Corporation THALIDOMIDE 50 mg/1 Decreased Immunologically Active Molecule Activity [PE] 59572-210_62e5a320-fb7c-11e3-a3ac-0800200c9a66 59572-210 HUMAN PRESCRIPTION DRUG Thalomid Thalidomide CAPSULE ORAL 20030620 NDA NDA020785 Celgene Corporation THALIDOMIDE 100 mg/1 Decreased Immunologically Active Molecule Activity [PE] 59572-215_62e5a320-fb7c-11e3-a3ac-0800200c9a66 59572-215 HUMAN PRESCRIPTION DRUG Thalomid Thalidomide CAPSULE ORAL 20070320 NDA NDA020785 Celgene Corporation THALIDOMIDE 150 mg/1 Decreased Immunologically Active Molecule Activity [PE] 59572-220_62e5a320-fb7c-11e3-a3ac-0800200c9a66 59572-220 HUMAN PRESCRIPTION DRUG Thalomid Thalidomide CAPSULE ORAL 20030620 NDA NDA020785 Celgene Corporation THALIDOMIDE 200 mg/1 Decreased Immunologically Active Molecule Activity [PE] 59572-402_2cf4ccfb-425d-11e4-916c-0800200c9a66 59572-402 HUMAN PRESCRIPTION DRUG Revlimid Lenalidomide CAPSULE ORAL 20120416 NDA NDA021880 Celgene Corporation LENALIDOMIDE 2.5 mg/1 Thalidomide Analog [EPC] 59572-405_2cf4ccfb-425d-11e4-916c-0800200c9a66 59572-405 HUMAN PRESCRIPTION DRUG Revlimid Lenalidomide CAPSULE ORAL 20051227 NDA NDA021880 Celgene Corporation LENALIDOMIDE 5 mg/1 Thalidomide Analog [EPC] 59572-410_2cf4ccfb-425d-11e4-916c-0800200c9a66 59572-410 HUMAN PRESCRIPTION DRUG Revlimid Lenalidomide CAPSULE ORAL 20051227 NDA NDA021880 Celgene Corporation LENALIDOMIDE 10 mg/1 Thalidomide Analog [EPC] 59572-415_2cf4ccfb-425d-11e4-916c-0800200c9a66 59572-415 HUMAN PRESCRIPTION DRUG Revlimid Lenalidomide CAPSULE ORAL 20060629 NDA NDA021880 Celgene Corporation LENALIDOMIDE 15 mg/1 Thalidomide Analog [EPC] 59572-420_2cf4ccfb-425d-11e4-916c-0800200c9a66 59572-420 HUMAN PRESCRIPTION DRUG Revlimid Lenalidomide CAPSULE ORAL 20130606 NDA NDA021880 Celgene Corporation LENALIDOMIDE 20 mg/1 Thalidomide Analog [EPC] 59572-425_2cf4ccfb-425d-11e4-916c-0800200c9a66 59572-425 HUMAN PRESCRIPTION DRUG Revlimid Lenalidomide CAPSULE ORAL 20060629 NDA NDA021880 Celgene Corporation LENALIDOMIDE 25 mg/1 Thalidomide Analog [EPC] 59572-501_fc515480-c726-11e3-9c1a-0800200c9a66 59572-501 HUMAN PRESCRIPTION DRUG Pomalyst pomalidomide CAPSULE ORAL 20130218 NDA NDA204026 Celgene Corporation POMALIDOMIDE 1 mg/1 Thalidomide Analog [EPC] 59572-502_fc515480-c726-11e3-9c1a-0800200c9a66 59572-502 HUMAN PRESCRIPTION DRUG Pomalyst pomalidomide CAPSULE ORAL 20130218 NDA NDA204026 Celgene Corporation POMALIDOMIDE 2 mg/1 Thalidomide Analog [EPC] 59572-503_fc515480-c726-11e3-9c1a-0800200c9a66 59572-503 HUMAN PRESCRIPTION DRUG Pomalyst pomalidomide CAPSULE ORAL 20130218 NDA NDA204026 Celgene Corporation POMALIDOMIDE 3 mg/1 Thalidomide Analog [EPC] 59572-504_fc515480-c726-11e3-9c1a-0800200c9a66 59572-504 HUMAN PRESCRIPTION DRUG Pomalyst pomalidomide CAPSULE ORAL 20130218 NDA NDA204026 Celgene Corporation POMALIDOMIDE 4 mg/1 Thalidomide Analog [EPC] 59572-630_c3023960-47f5-11e4-916c-0800200c9a66 59572-630 HUMAN PRESCRIPTION DRUG OTEZLA apremilast KIT ORAL 20140401 NDA NDA205437 Celgene Corporation 59572-631_c3023960-47f5-11e4-916c-0800200c9a66 59572-631 HUMAN PRESCRIPTION DRUG OTEZLA apremilast TABLET, FILM COATED ORAL 20140403 NDA NDA205437 Celgene Corporation APREMILAST 30 mg/1 Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA] 59572-983_55ff9434-a888-4a33-9fef-c15c4ce04411 59572-983 HUMAN PRESCRIPTION DRUG ISTODAX romidepsin KIT 20100104 NDA NDA022393 Celgene Corporation 59575-500_b477f21e-c0cc-48cd-8d9d-f3d1da2f1653 59575-500 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20130730 OTC MONOGRAPH NOT FINAL part333A Hebei Yihoucheng Commodity Co.,Ltd. BENZALKONIUM CHLORIDE .1 g/100g 59575-501_6ecc1ca0-6f7b-4d6d-bb67-841077457c30 59575-501 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20130816 OTC MONOGRAPH NOT FINAL part333A Hebei Yihoucheng Commodity Co.,Ltd. BENZALKONIUM CHLORIDE .115 g/100g 59579-001_22acd6ba-e12c-4a9f-bfeb-2186049a8b20 59579-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20071001 NDA NDA205849 Praxair Distribution, Inc. OXYGEN 990 mL/L 59579-002_19f32835-48a1-45ee-ba93-b85b66f2319f 59579-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Praxair Distribution, Inc. NITROGEN 990 mL/L 59579-003_ed5e677f-9713-4897-9734-826951f4d39d 59579-003 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20080901 UNAPPROVED MEDICAL GAS Praxair Distribution, Inc. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 59579-004_3bc88c01-b246-45f4-9422-5aec39f0f27b 59579-004 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Praxair Distribution, Inc. NITROUS OXIDE 990 mL/L 59579-005_6a6584c8-6ddf-4bac-973f-f99626ecd90a 59579-005 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 20071201 NDA NDA205912 Praxair Distribution, Inc. HELIUM 990 mL/L 59579-006_40ac9cf2-3ae9-41e4-8848-4f6b10dde4ad 59579-006 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20020501 NDA NDA205910 Praxair Distribution, Inc. AIR 1000 mL/L 59579-008_7816b99a-baf0-4540-a91c-55e8dbe90100 59579-008 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mix Carbon Dioxide Oxygen Mix GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Praxair Distribution, Inc CARBON DIOXIDE; OXYGEN 300; 700 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 59579-009_8e01de6f-431f-46c2-805f-bcb8fa478ff6 59579-009 HUMAN PRESCRIPTION DRUG Helium Oxygen mixture Helium Oxygen mixture GAS RESPIRATORY (INHALATION) 20070801 UNAPPROVED MEDICAL GAS Praxair Distribution, Inc. HELIUM; OXYGEN 800; 200 mL/L; mL/L 59579-010_99dcf466-145b-47d4-a9f9-d586f3d5b84d 59579-010 HUMAN PRESCRIPTION DRUG Helium Oxygen Nitrogen mixture Helium Oxygen Nitrogen mixture GAS RESPIRATORY (INHALATION) 20051001 UNAPPROVED MEDICAL GAS Praxair Distribution, Inc. HELIUM; NITROGEN; OXYGEN 200; 300; 500 mL/L; mL/L; mL/L 59582-015_997eab00-8eda-4444-931a-06bfa9094b68 59582-015 HUMAN OTC DRUG Black Rice Platinum Absolute Youth SPF 15 Avobenzone, Ensulizole, Octinoxate, and Octocrylene CREAM TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part352 EBPD LLC AVOBENZONE; ENSULIZOLE; OCTINOXATE; OCTOCRYLENE 30; 20; 20; 50 mg/mL; mg/mL; mg/mL; mg/mL 59584-138_0e160863-0d38-47ef-ac7f-565e076c5ebd 59584-138 STANDARDIZED ALLERGENIC Candin Candida albicans Skin Test Antigen INJECTION, SOLUTION INTRADERMAL 19951201 BLA BLA103257 Nielsen Biosciences, Inc. CANDIDA ALBICANS 1 U/.1mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 59584-140_04f0d499-26c5-1d4c-e054-00144ff88e88 59584-140 HUMAN PRESCRIPTION DRUG Spherusol Coccidioides immitis Spherule-Derived Skin Test Antigen INJECTION, SOLUTION INTRADERMAL 20110729 BLA BLA125354 Nielsen BioSciences, Inc. COCCIDIOIDES IMMITIS SPHERULE 12.7 ug/mL Skin Test Antigen [EPC],Cell-mediated Immunity [PE],Antigens, Fungal [Chemical/Ingredient] 59608-001_608f1492-7d41-43fe-9247-9edf78fab409 59608-001 HUMAN OTC DRUG TENA Protective Cream Zinc Oxide CREAM TOPICAL 20131003 OTC MONOGRAPH FINAL part347 SCA Personal Care Inc. ZINC OXIDE 100 mg/mL 59614-221_10ada59f-faaf-47e7-b15a-b96e5118ebe1 59614-221 HUMAN OTC DRUG Sun Protection Emulsion Face la prairie Avobenzone, Homosalate, octisalate, octocrylene, oxybenzone CREAM TOPICAL 20110214 OTC MONOGRAPH FINAL part352 Juvena GMBH AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 2.5; 2.4; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 59614-298_c98d5239-4a7c-41fa-9e14-5e72d065ac5a 59614-298 HUMAN OTC DRUG Anti-Aging Eye Cream SPF 15 Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20081204 OTC MONOGRAPH FINAL part352 Juvena Produits de Beaute GMBH AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.8; 7.5; 5; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL 59614-301_57da029e-b645-4e14-8bcf-659432050e0d 59614-301 HUMAN OTC DRUG La Prairie Switzerland Cellular Radiance Emulsion Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Juvena Produits de Beaute AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 mL/100mL; mL/100mL; mL/100mL 59614-311_148adfb5-b153-4f3f-b5bc-b040c2f8e63b 59614-311 HUMAN OTC DRUG La Prairie Switzerland Cellular Blemish Control Salicylic Acid CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Juvena Produits de Beaute GMBH SALICYLIC ACID 2 mCi/100mL 59614-347_8c46e5a4-f552-4a5b-bab3-ad2d2bab6959 59614-347 HUMAN PRESCRIPTION DRUG La Prairie Switzerland Anti-Aging Day Cream SPF 30 Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20080101 OTC MONOGRAPH FINAL part352 Juvena Produits de Beaute GMBH AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 7.5; 5; 2.5 mL/100mL; mL/100mL; mL/5mL; mL/100mL 59614-411_6b94b7e6-b3f0-40da-94e8-1c3c906fafb7 59614-411 HUMAN OTC DRUG La Prairie Switzerland Anti-Wrinkle SunScreen SPF 30 Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Juvena Produits de Beaute GMBH AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 2.6; 2.4; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 59614-511_b89511ec-8fc8-4c35-8600-320f915312f6 59614-511 HUMAN OTC DRUG Sun protection body SPF 30 Avobenzone, Homosalate, Octislate, Oxybenzone LOTION TOPICAL 20110214 OTC MONOGRAPH FINAL part352 Juvena Produits de Beaute GMBH AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 7; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 59614-738_afcf314c-3245-4813-95e5-cfd0fa28d496 59614-738 HUMAN OTC DRUG Ultra Protection stick La prarie Switerland Avobenzone, Homosalate, Octisalate, Oxybenzone STICK TOPICAL 20110214 OTC MONOGRAPH FINAL part352 Juvena Produits De Beaute GMBH AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 7; 5; 2 g/100g; g/100g; g/100g; g/100g 59617-0010_a0c86811-3d3b-4231-b6c7-ef44da499d5d 59617-0010 STANDARDIZED ALLERGENIC Oralair 100 IR ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20140430 BLA BLA125471 Stallergenes S.A ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 100; 100; 100; 100; 100 [IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1 Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 59617-0015_a0c86811-3d3b-4231-b6c7-ef44da499d5d 59617-0015 STANDARDIZED ALLERGENIC Oralair 300 IR ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20140430 BLA BLA125471 Stallergenes S.A ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 300; 300; 300; 300; 300 [IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1 Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 59617-0016_a0c86811-3d3b-4231-b6c7-ef44da499d5d 59617-0016 STANDARDIZED ALLERGENIC Oralair 300 IR ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20140430 BLA BLA125471 Stallergenes S.A ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 300; 300; 300; 300; 300 [IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1 Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 59617-0020_a0c86811-3d3b-4231-b6c7-ef44da499d5d 59617-0020 STANDARDIZED ALLERGENIC Oralair ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN KIT 20140430 BLA BLA125471 Stallergenes S.A 59617-0025_a0c86811-3d3b-4231-b6c7-ef44da499d5d 59617-0025 STANDARDIZED ALLERGENIC Oralair ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN KIT 20140430 BLA BLA125471 Stallergenes S.A 59623-001_b2abb503-f766-40ab-8e84-f05e9789d847 59623-001 HUMAN OTC DRUG Seasonal Allergy Formula Hydrastis Canadensis, Kali Muriaticum, Gelsemium Sempervirens, Kali Bichromicum, Sabadilla, Histaminum, House Dust, Grass Mix, Trees Mix, Weeds Mix LIQUID ORAL 20130722 UNAPPROVED HOMEOPATHIC Integrative Healing Institute, LLC ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; ALNUS RUBRA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXANTHUM ODORATUM; ARTEMISIA VULGARIS POLLEN; BARLEY; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA PUBESCENS FLOWER BUD; BROMUS SECALINUS POLLEN; CARYA GLABRA POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; HOUSE DUST; JUGLANS REGIA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MELILOTUS OFFICINALIS TOP; MORUS RUBRA POLLEN; PHLEUM PRATENSE TOP; PINUS NIGRA POLLEN; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; QUERCUS ALBA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS MARILANDICA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS STELLATA POLLEN; RUMEX ACETOSELLA POLLEN; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN; ULMUS RUBRA POLLEN; ZEA MAYS POLLEN 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 12; 4; 30; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 12; 6; 6; 6; 6; 6; 6; 12; 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 59623-002_88fd3695-88b9-4bf7-ad9d-b0d53a001234 59623-002 HUMAN OTC DRUG Soothing Respiratory Rub Chamomilla, Myrrha, Rosmarinus, Ruta, Symphytum, Antimon Tart, RSV. GEL TOPICAL 20131223 UNAPPROVED HOMEOPATHIC Integrative Healing Institute, LLC ANTIMONY POTASSIUM TARTRATE; COMFREY ROOT; MATRICARIA RECUTITA; MYRRH; RESPIRATORY SYNCYTIAL VIRUS IMMUNE GLOBULIN INTRAVENOUS (HUMAN); ROSMARINUS OFFICINALIS FLOWERING TOP; RUTA GRAVEOLENS FLOWERING TOP 6; 6; 3; 3; 30; 3; 5 [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g 59623-003_1b1f65b0-ebda-4b5c-b26e-4ce78338bba6 59623-003 HUMAN OTC DRUG Mold Relief Formula Kali Muriaticum, Gelsemium, Kali Bichromicum, Sabadilla, Histaminum, Mold Mix. LIQUID ORAL 20130923 UNAPPROVED HOMEOPATHIC Integrative Healing Institute, LLC ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BOLETUS SATANAS FRUITING BODY; BOTRYTIS CINEREA; CANDIDA ALBICANS; COCHLIOBOLUS SATIVUS; FUSARIUM OXYSPORUM; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; PASSALORA FULVA; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; RHIZOPUS STOLONIFER; SCHOENOCAULON OFFICINALE SEED; USTILAGO MAYDIS 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 12; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 59623-004_b6097cf8-c538-42c2-8249-f16f2f8c52c4 59623-004 HUMAN OTC DRUG Breathe Easier Formula Cupressus Aus, Eucalyptus, Mentha Pip, Origanum, Pinus Syl, Salvia, Kali Iod, Euphorbium, Galphimia, Hydrastis, Luffa, Pulsatilla, Hepar Suplh Calc, Histaminum, Kali Bic. SPRAY NASAL 20130923 UNAPPROVED HOMEOPATHIC Integrative Healing Institute, LLC CALCIUM SULFIDE; CUPRESSUS SEMPERVIRENS FRUITING LEAFY TWIG; EUCALYPTUS GLOBULUS LEAF; EUPHORBIA RESINIFERA RESIN; GALPHIMIA GLAUCA FLOWERING TOP; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; MENTHA PIPERITA; ORIGANUM MAJORANA WHOLE; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; SAGE 12; 3; 3; 6; 6; 6; 12; 6; 3; 3; 3; 12; 4; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 59623-005_43c5f200-7fe1-48f6-ba0b-3a52a89763ce 59623-005 HUMAN OTC DRUG Cold and Flu Formula Aconitum Napellus, Gelsemium Sempervirens, Ruta Graveolens, Ambra Grisea, Kali Carbonicum, Natrum Muriaticum, Bryonia Alba, Anas Barbariae, Cenchris Contortrix, Influenzinum. LIQUID ORAL 20131104 UNAPPROVED HOMEOPATHIC Integrative Healing Institute, LLC ACONITUM NAPELLUS; AGKISTRODON CONTORTRIX VENOM; AMBERGRIS; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; POTASSIUM CARBONATE; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE 3; 30; 6; 12; 30; 4; 34; 34; 6; 5; 6 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 59623-006_f8723aa9-3720-4701-877c-9c82734e1337 59623-006 HUMAN OTC DRUG Cedar X Formula Olibanum, Thuja Occidentalis, Gelsemium Sempervirens, Allium Cepa, Antimonium Tartaricum, Hepar Sulphuris Calcareum, Juniperus Communis. LIQUID ORAL 20131105 UNAPPROVED HOMEOPATHIC Integrative Healing Institute, LLC ANTIMONY POTASSIUM TARTRATE; CALCIUM SULFIDE; FRANKINCENSE; GELSEMIUM SEMPERVIRENS ROOT; JUNIPER BERRY; ONION; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 3; 4; 30; 6; 3 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 59623-008_f2a87f5c-aee3-40b3-8db3-43a3aa3a2f41 59623-008 HUMAN OTC DRUG Cedar X Children Formula Olibanum, Thuja Occidentalis, Gelsemium Sempervirens, Red Cedar, Allium Cepa, Antimonium Tartaricum, Hepar Sulphuris Calcareum, Juniperus Communis. LIQUID ORAL 20131107 UNAPPROVED HOMEOPATHIC Integrative Healing Institute, LLC ANTIMONY POTASSIUM TARTRATE; CALCIUM SULFIDE; FRANKINCENSE; GELSEMIUM SEMPERVIRENS ROOT; JUNIPER BERRY; JUNIPERUS VIRGINIANA POLLEN; ONION; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 3; 4; 30; 4; 6; 3 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 59623-009_c1aed624-1c82-4cce-bda4-9594a4f73ea9 59623-009 HUMAN OTC DRUG Cedar X Pet Formula Olibanum, Thuja Occidentalis, Gelsemium Sempervirens, Red Cedar, Allium Cepa, Antimonium Tartaricum, Hepar Sulphuris Calcareum, Juniperus Communis. LIQUID ORAL 20131106 UNAPPROVED HOMEOPATHIC Integrative Healing Institute, LLC ANTIMONY POTASSIUM TARTRATE; CALCIUM SULFIDE; FRANKINCENSE; GELSEMIUM SEMPERVIRENS ROOT; JUNIPER BERRY; JUNIPERUS VIRGINIANA POLLEN; ONION; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 3; 4; 30; 4; 6; 3 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 59623-010_5def050f-3d12-4f9c-b775-e5e02afd70bf 59623-010 HUMAN OTC DRUG Seasonal Allergy Pet Formula Hydrastis Canadensis, Kali Muriaticum, Gelsemium Sempervirens, Kali Bichromicum, Sabadilla, Histaminum, House Dust, Grass Mix, Trees Mix, Weeds Mix LIQUID ORAL 20131107 UNAPPROVED HOMEOPATHIC Integrative Healing Institute, LLC ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; ALNUS RUBRA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXANTHUM ODORATUM; ARTEMISIA VULGARIS POLLEN; BARLEY; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA PUBESCENS FLOWER BUD; BROMUS SECALINUS POLLEN; CARYA GLABRA POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CARYA TOMENTOSA POLLEN; CYNODON DACTYLON POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; HOUSE DUST; JUGLANS REGIA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MELILOTUS OFFICINALIS TOP; MORUS RUBRA POLLEN; PHLEUM PRATENSE TOP; PINUS NIGRA POLLEN; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; QUERCUS ALBA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS MARILANDICA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS STELLATA POLLEN; RUMEX ACETOSELLA POLLEN; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN; ULMUS RUBRA POLLEN; ZEA MAYS POLLEN 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 12; 4; 30; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 12; 6; 6; 6; 6; 6; 6; 12; 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 59627-001_4c6158f1-ef8f-417c-b6b3-66ed94fe8f01 59627-001 HUMAN PRESCRIPTION DRUG AVONEX interferon beta-1a INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 19960517 BLA BLA103628 Biogen Idec Inc. INTERFERON BETA-1A 30 ug/mL Interferon-beta [Chemical/Ingredient],Recombinant Human Interferon beta [EPC],Recombinant Proteins [Chemical/Ingredient] 59627-002_4c6158f1-ef8f-417c-b6b3-66ed94fe8f01 59627-002 HUMAN PRESCRIPTION DRUG AVONEX interferon beta-1a INJECTION, SOLUTION INTRAMUSCULAR 20030523 BLA BLA103628 Biogen Idec Inc. INTERFERON BETA-1A 30 ug/.5mL Interferon-beta [Chemical/Ingredient],Recombinant Human Interferon beta [EPC],Recombinant Proteins [Chemical/Ingredient] 59627-003_4c6158f1-ef8f-417c-b6b3-66ed94fe8f01 59627-003 HUMAN PRESCRIPTION DRUG AVONEX PEN interferon beta-1a INJECTION, SOLUTION INTRAMUSCULAR 20030523 BLA BLA103628 Biogen Idec Inc. INTERFERON BETA-1A 30 ug/.5mL Interferon-beta [Chemical/Ingredient],Recombinant Human Interferon beta [EPC],Recombinant Proteins [Chemical/Ingredient] 59627-111_4c6158f1-ef8f-417c-b6b3-66ed94fe8f01 59627-111 HUMAN PRESCRIPTION DRUG AVONEX interferon beta-1a KIT INTRAMUSCULAR 20140829 BLA BLA103628 Biogen Idec Inc. 59627-222_4c6158f1-ef8f-417c-b6b3-66ed94fe8f01 59627-222 HUMAN PRESCRIPTION DRUG AVONEX interferon beta-1a KIT INTRAMUSCULAR 20140829 BLA BLA103628 Biogen Idec Inc. 59627-333_4c6158f1-ef8f-417c-b6b3-66ed94fe8f01 59627-333 HUMAN PRESCRIPTION DRUG AVONEX interferon beta-1a KIT INTRAMUSCULAR 20140829 BLA BLA103628 Biogen Idec Inc. 59630-074_d947e9d1-68fa-4ea7-8ea7-e46ccf04a5df 59630-074 HUMAN PRESCRIPTION DRUG Dolgic Plus butalbital, acetaminophen and caffeine TABLET ORAL 20111010 ANDA ANDA040496 Shionogi Inc ACETAMINOPHEN; BUTALBITAL; CAFFEINE 750; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 59630-112_fa00f77b-f5e4-4df1-9699-8be1d9aabf59 59630-112 HUMAN PRESCRIPTION DRUG Keflex cephalexin CAPSULE ORAL 19710104 NDA NDA050405 Shionogi Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 59630-113_fa00f77b-f5e4-4df1-9699-8be1d9aabf59 59630-113 HUMAN PRESCRIPTION DRUG Keflex cephalexin CAPSULE ORAL 19710104 NDA NDA050405 Shionogi Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 59630-115_fa00f77b-f5e4-4df1-9699-8be1d9aabf59 59630-115 HUMAN PRESCRIPTION DRUG Keflex cephalexin CAPSULE ORAL 19710104 NDA NDA050405 Shionogi Inc. CEPHALEXIN 750 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 59630-142_ed26df73-eb05-45c4-994f-17928dc052d1 59630-142 HUMAN PRESCRIPTION DRUG Moxatag amoxicillin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110826 NDA NDA050813 Shionogi Inc. AMOXICILLIN 775 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 59630-170_ab5defdf-7e18-4579-bdda-5204a0de781e 59630-170 HUMAN PRESCRIPTION DRUG Zebutal Butalbital, acetaminophen and caffeine CAPSULE ORAL 19981028 ANDA ANDA040261 Shionogi Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 59630-200_81777c49-9cf0-4835-b791-1b7776d70af9 59630-200 HUMAN PRESCRIPTION DRUG Robinul Glycopyrrolate TABLET ORAL 19610328 NDA NDA012827 Shionogi Inc. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 59630-205_81777c49-9cf0-4835-b791-1b7776d70af9 59630-205 HUMAN PRESCRIPTION DRUG Robinul Forte Glycopyrrolate TABLET ORAL 19610328 NDA NDA012827 Shionogi Inc. GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 59630-309_c852748b-6d1f-44b6-afff-8403cebfca4f 59630-309 HUMAN PRESCRIPTION DRUG Doribax doripenem POWDER, FOR SOLUTION INTRAVENOUS 20101015 NDA NDA022106 Shionogi Inc. DORIPENEM 250 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 59630-320_c852748b-6d1f-44b6-afff-8403cebfca4f 59630-320 HUMAN PRESCRIPTION DRUG Doribax doripenem POWDER, FOR SOLUTION INTRAVENOUS 20071012 NDA NDA022106 Shionogi Inc. DORIPENEM 500 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 59630-375_00ea44c7-97e5-426f-b0f2-8884e8bfa7dc 59630-375 HUMAN PRESCRIPTION DRUG Naprelan Naproxen Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960401 NDA NDA020353 Shionogi Inc. NAPROXEN SODIUM 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 59630-400_6054a91f-3a44-4acb-b7e7-dbdcb248ab04 59630-400 HUMAN PRESCRIPTION DRUG Ponstel mefenamic acid CAPSULE ORAL 19670328 NDA NDA015034 Shionogi Inc. MEFENAMIC ACID 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 59630-450_49f55e68-c67b-40bf-a908-742c72229711 59630-450 HUMAN PRESCRIPTION DRUG Furadantin nitrofurantoin SUSPENSION ORAL 19531223 NDA NDA009175 Shionogi Inc. NITROFURANTOIN 25 mg/5mL Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 59630-480_05474f9a-e70a-4c94-8a8a-349adcdaba63 59630-480 HUMAN PRESCRIPTION DRUG Triglide fenofibrate TABLET ORAL 20050507 NDA NDA021350 Shionogi Inc. FENOFIBRATE 50 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 59630-485_05474f9a-e70a-4c94-8a8a-349adcdaba63 59630-485 HUMAN PRESCRIPTION DRUG Triglide fenofibrate TABLET ORAL 20050507 NDA NDA021350 Shionogi Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 59630-500_221ce238-0e55-4b2e-9477-35a438b67faf 59630-500 HUMAN PRESCRIPTION DRUG SULAR Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19950202 NDA NDA020356 Shionogi Inc. NISOLDIPINE 8.5 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 59630-501_221ce238-0e55-4b2e-9477-35a438b67faf 59630-501 HUMAN PRESCRIPTION DRUG SULAR Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19950202 NDA NDA020356 Shionogi Inc. NISOLDIPINE 17 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 59630-503_221ce238-0e55-4b2e-9477-35a438b67faf 59630-503 HUMAN PRESCRIPTION DRUG SULAR Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19950202 NDA NDA020356 Shionogi Inc. NISOLDIPINE 34 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 59630-574_4e7981cb-b6b4-4876-804b-97d05d4e9420 59630-574 HUMAN PRESCRIPTION DRUG FORTAMET metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20040427 NDA NDA021574 Shionogi Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 59630-575_4e7981cb-b6b4-4876-804b-97d05d4e9420 59630-575 HUMAN PRESCRIPTION DRUG FORTAMET metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20040427 NDA NDA021574 Shionogi Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 59630-580_ddf76822-234d-4113-b136-46516d9b9838 59630-580 HUMAN PRESCRIPTION DRUG Osphena Ospemifene TABLET, FILM COATED ORAL 20130226 NDA NDA203505 Shionogi Inc. OSPEMIFENE 60 mg/1 59630-628_fb09cd9c-f016-438f-871f-c40a4f1b0dc6 59630-628 HUMAN PRESCRIPTION DRUG Altoprev lovastatin TABLET, EXTENDED RELEASE ORAL 20020626 NDA NDA021316 Shionogi Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59630-629_fb09cd9c-f016-438f-871f-c40a4f1b0dc6 59630-629 HUMAN PRESCRIPTION DRUG Altoprev lovastatin TABLET, EXTENDED RELEASE ORAL 20020626 NDA NDA021316 Shionogi Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59630-630_fb09cd9c-f016-438f-871f-c40a4f1b0dc6 59630-630 HUMAN PRESCRIPTION DRUG Altoprev lovastatin TABLET, EXTENDED RELEASE ORAL 20020626 NDA NDA021316 Shionogi Inc. LOVASTATIN 60 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59630-700_07963f2f-7bb8-4f99-bd1b-738d501019ec 59630-700 HUMAN PRESCRIPTION DRUG Orapred ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING ORAL 20060601 NDA NDA021959 Shionogi Inc. PREDNISOLONE SODIUM PHOSPHATE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59630-701_07963f2f-7bb8-4f99-bd1b-738d501019ec 59630-701 HUMAN PRESCRIPTION DRUG Orapred ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING ORAL 20060601 NDA NDA021959 Shionogi Inc. PREDNISOLONE SODIUM PHOSPHATE 15 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59630-702_07963f2f-7bb8-4f99-bd1b-738d501019ec 59630-702 HUMAN PRESCRIPTION DRUG Orapred ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING ORAL 20060601 NDA NDA021959 Shionogi Inc. PREDNISOLONE SODIUM PHOSPHATE 30 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59630-710_2f979900-06e3-4edd-b67a-c99e308df4d4 59630-710 HUMAN PRESCRIPTION DRUG Orapred prednisolone sodium phosphate SOLUTION ORAL 20001214 ANDA ANDA075117 Shionogi Inc. PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59630-750_20a4cd99-58d9-49a4-b249-38186749c0d4 59630-750 HUMAN PRESCRIPTION DRUG Methylin Methylphenidate Hydrochloride SOLUTION ORAL 20101101 NDA NDA021419 SHIONOGI INC. METHYLPHENIDATE HYDROCHLORIDE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 59630-755_20a4cd99-58d9-49a4-b249-38186749c0d4 59630-755 HUMAN PRESCRIPTION DRUG Methylin Methylphenidate Hydrochloride SOLUTION ORAL 20101101 NDA NDA021419 SHIONOGI INC. METHYLPHENIDATE HYDROCHLORIDE 10 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 59630-760_457b5746-ee91-4bb0-a012-db2486c410d8 59630-760 HUMAN PRESCRIPTION DRUG METHYLIN methylphenidate hydrochloride TABLET, CHEWABLE ORAL 20101101 NDA NDA021475 SHIONOGI INC. METHYLPHENIDATE HYDROCHLORIDE 2.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 59630-761_457b5746-ee91-4bb0-a012-db2486c410d8 59630-761 HUMAN PRESCRIPTION DRUG METHYLIN methylphenidate hydrochloride TABLET, CHEWABLE ORAL 20101101 NDA NDA021475 SHIONOGI INC. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 59630-762_457b5746-ee91-4bb0-a012-db2486c410d8 59630-762 HUMAN PRESCRIPTION DRUG METHYLIN methylphenidate hydrochloride TABLET, CHEWABLE ORAL 20101101 NDA NDA021475 SHIONOGI INC. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 59630-777_00ea44c7-97e5-426f-b0f2-8884e8bfa7dc 59630-777 HUMAN PRESCRIPTION DRUG Naprelan Naproxen Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960401 NDA NDA020353 Shionogi Inc. NAPROXEN SODIUM 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 59630-780_b3728b10-c3e4-4336-9135-b75b56f82d5c 59630-780 HUMAN PRESCRIPTION DRUG Ulesfia benzyl alcohol LOTION TOPICAL 20090526 NDA NDA022129 Shionogi Inc. BENZYL ALCOHOL 50 mg/g Pediculicide [EPC] 59630-820_d1672f05-b1ee-40f9-9b4c-7ba2fad264fc 59630-820 HUMAN PRESCRIPTION DRUG Cedax Ceftibuten dihydrate CAPSULE ORAL 19951220 NDA NDA050685 Sciele Pharma, Inc. CEFTIBUTEN DIHYDRATE 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 59630-821_d1672f05-b1ee-40f9-9b4c-7ba2fad264fc 59630-821 HUMAN PRESCRIPTION DRUG Cedax Ceftibuten dihydrate SUSPENSION ORAL 19951220 NDA NDA050686 Sciele Pharma, Inc. CEFTIBUTEN DIHYDRATE 18 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 59630-825_8c52efa9-9cf1-4827-a512-f74cb960a667 59630-825 HUMAN PRESCRIPTION DRUG Rybix ODT tramadol hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20050505 NDA NDA021693 Shionogi Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 59630-850_00ea44c7-97e5-426f-b0f2-8884e8bfa7dc 59630-850 HUMAN PRESCRIPTION DRUG Naprelan Naproxen Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960401 NDA NDA020353 Shionogi Inc. NAPROXEN SODIUM 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 59630-911_d5f24f49-2348-495d-b0d2-357eb2b564e3 59630-911 HUMAN PRESCRIPTION DRUG Xodol hydrocodone bitartrate and acetaminophen TABLET ORAL 20111010 ANDA ANDA040556 Shionogi Inc ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 59630-912_d5f24f49-2348-495d-b0d2-357eb2b564e3 59630-912 HUMAN PRESCRIPTION DRUG Xodol hydrocodone bitartrate and acetaminophen TABLET ORAL 20111010 ANDA ANDA040658 Shionogi Inc ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 59630-913_d5f24f49-2348-495d-b0d2-357eb2b564e3 59630-913 HUMAN PRESCRIPTION DRUG Xodol hydrocodone bitartrate and acetaminophen TABLET ORAL 20111010 ANDA ANDA040556 Shionogi Inc ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 59630-950_3a65a620-04cb-4575-af51-11cfd5ba7002 59630-950 HUMAN PRESCRIPTION DRUG Fexmid Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20111001 ANDA ANDA071611 Shionogi Inc. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 59630-992_bf58ecb4-29e0-4ebf-9fba-bc940fa304e7 59630-992 HUMAN PRESCRIPTION DRUG Magnacet oxycodone and acetaminophen TABLET ORAL 20111017 ANDA ANDA040687 Shionogi Inc ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 400; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59630-993_bf58ecb4-29e0-4ebf-9fba-bc940fa304e7 59630-993 HUMAN PRESCRIPTION DRUG Magnacet oxycodone and acetaminophen TABLET ORAL 20111017 ANDA ANDA040698 Shionogi Inc ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 400; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59630-994_bf58ecb4-29e0-4ebf-9fba-bc940fa304e7 59630-994 HUMAN PRESCRIPTION DRUG Magnacet oxycodone and acetaminophen TABLET ORAL 20111017 ANDA ANDA040692 Shionogi Inc ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 400; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 59640-016_369a9775-614a-4160-8ac7-d6abbfa9898f 59640-016 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090209 OTC MONOGRAPH FINAL part335 H.E.B BISMUTH SUBSALICYLATE 262 mg/15mL 59640-024_05483ad4-4f8b-40a9-b586-38b7c0da892b 59640-024 HUMAN OTC DRUG Peptic Relief Maximum Strength BISMUTH SUBSALICYLATE SUSPENSION ORAL 20090209 OTC MONOGRAPH FINAL part341 H.E.B BISMUTH SUBSALICYLATE 525 mg/15mL 59640-025_a9997a77-888c-4122-a35c-adf8b47e784f 59640-025 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20100302 OTC MONOGRAPH FINAL part341 H.E.B DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 59640-072_3bd82375-97ec-46b1-b9ad-32f10b6db21b 59640-072 HUMAN OTC DRUG Night Time Cherry DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20090603 OTC MONOGRAPH FINAL part341 H.E.B DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 135 mg/15mL; mg/5mL 59640-072_5a38c25e-21b5-411f-82e0-5821ad4884e9 59640-072 HUMAN OTC DRUG Night Time Cherry DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20090616 OTC MONOGRAPH FINAL part341 H.E.B DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 135 mg/15mL; mg/5mL 59640-098_3f3579f1-e532-4cb2-9c15-508c7e865a15 59640-098 HUMAN OTC DRUG Tussin Cough Long Acting DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20100323 OTC MONOGRAPH FINAL part341 H.E.B DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL 59640-104_ba0aeac6-59f1-440a-9aba-9fb3451a2457 59640-104 HUMAN OTC DRUG Milk of Magnesia Wild Cherry MAGNESIUM HYDROXIDE SUSPENSION ORAL 20100302 OTC MONOGRAPH FINAL part334 H.E.B MAGNESIUM HYDROXIDE 1200 mg/15mL 59640-112_1ec755c8-cb30-4d3f-be05-681c248e8956 59640-112 HUMAN OTC DRUG Night Time Original Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, LIQUID ORAL 20090616 OTC MONOGRAPH FINAL part341 H.E.B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 59640-113_75ca226e-1432-435e-a10d-5ce2915ac787 59640-113 HUMAN OTC DRUG Night Time Cherry Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromidem, Doxylamine Succinate LIQUID ORAL 20090921 OTC MONOGRAPH FINAL part341 H.E.B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 59640-154_915781d5-f4f5-41e2-af66-36253548eac2 59640-154 HUMAN OTC DRUG Flu Relief Therapy Night Time Acetaminophen, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20100302 OTC MONOGRAPH FINAL part341 H.E.B ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL 59640-155_9a677a1a-e591-4a91-8d56-416fce48bd46 59640-155 HUMAN OTC DRUG Flu Relief Therapy Day Time Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20100302 OTC MONOGRAPH FINAL part341 H.E.B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 59640-158_c62c1ecd-ea0f-46e9-8fc3-fdd2eeba2f8d 59640-158 HUMAN OTC DRUG Childrens Mucus Relief Cherry DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20100323 OTC MONOGRAPH FINAL part341 H.E.B. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 59647-243_403f6f18-6d6c-40d0-8273-b8ef3827c0e3 59647-243 HUMAN OTC DRUG MED NAP CLEANSING BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130909 OTC MONOGRAPH NOT FINAL part333E Med-Nap LLC BENZALKONIUM CHLORIDE 1.3 mg/1.7mL 59647-244_646b6686-22c2-4475-a850-9213d5c0a417 59647-244 HUMAN OTC DRUG MED NAP OBSTETRICAL BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130909 OTC MONOGRAPH NOT FINAL part333E Med-Nap LLC BENZALKONIUM CHLORIDE 1.3 mg/1.7mL 59647-245_92bb6bab-63de-493f-81f5-91e73c43fd15 59647-245 HUMAN OTC DRUG MED NAP BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130909 OTC MONOGRAPH NOT FINAL part333E Med-Nap LLC BENZALKONIUM CHLORIDE 1.3 mg/1.7mL 59663-001_887b89ab-92bf-4bfa-b6b3-73539f94255c 59663-001 HUMAN OTC DRUG MOISTURIZING SUNSCREEN SPF15 OXYBENZONE LOTION TOPICAL 19960202 OTC MONOGRAPH NOT FINAL part352 Shine & Pretty (USA), Corp. OCTINOXATE; OXYBENZONE 1; 1 mL/200mL; mL/100mL 59663-100_9cec24b1-f49f-426e-aba4-5c964231b908 59663-100 HUMAN OTC DRUG ROCK SAUCE METHYL SALICYLATE, MENTHOL, CAPSICUM LOTION TOPICAL 20120602 OTC MONOGRAPH NOT FINAL part348 Shine & Pretty (USA), Corp. CAPSICUM; MENTHOL; METHYL SALICYLATE .05; 10; 20 mL/100mL; mL/100mL; mL/100mL 59663-100_f5cf2d9b-ccf4-4ae9-b470-b384e19e8650 59663-100 HUMAN OTC DRUG ROCK SAUCE METHYL SALICYLATE, MENTHOL, CAPSICUM LOTION TOPICAL 20120413 OTC MONOGRAPH NOT FINAL part348 Shine & Pretty (USA), Corp. CAPSICUM; MENTHOL; METHYL SALICYLATE .05; 10; 20 mL/100mL; mL/100mL; mL/100mL 59663-110_37ca5bcc-de29-4713-b17e-2cd0b963056a 59663-110 HUMAN OTC DRUG Solar Defender SPF 30 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 Shine & Pretty (USA), Corp. OCTINOXATE; ZINC OXIDE 75; 100 mg/mL; mg/mL 59663-120_f14a4df5-50ee-4760-ae90-b4c722922586 59663-120 HUMAN OTC DRUG Planet Sun SPF 30 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Shine & Pretty (USA), Corp. OCTINOXATE; ZINC OXIDE 75; 100 mg/mL; mg/mL 59663-130_cd387d64-c499-403f-a819-c7a80983a566 59663-130 HUMAN OTC DRUG Epicuren Discovery SPF 30 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Shine & Pretty (USA), Corp. OCTINOXATE; ZINC OXIDE 75; 100 mg/mL; mg/mL 59663-140_2833baa3-9855-4573-8fc2-239eefa72a52 59663-140 HUMAN OTC DRUG Bella Pelle SPF 30 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Shine & Pretty (USA), Corp. OCTINOXATE; ZINC OXIDE 75; 100 mg/mL; mg/mL 59667-0001_a407937f-320d-4ed4-8582-efe2a4e7f9b7 59667-0001 HUMAN OTC DRUG Abundant Milk Aconite, Agnus Castus, Alfalfa, Asafeotida, Calcarea Carb, Chamomilla, Causticum, Dulcamara, Lac Caninum, Lactuca Virosa, Phosphoricum Acidum, Pulsatilla, Ricinus, Rhus Tox, Silicea, Sulphur, Thyroidinum, Urtica Urens, Zinc SPRAY ORAL 20130801 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ALFALFA; ASAFETIDA; CANIS LUPUS FAMILIARIS MILK; CAUSTICUM; CHASTE TREE; LACTUCA VIROSA; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PULSATILLA VULGARIS; RICINUS COMMUNIS WHOLE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; SULFUR; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF; URTICA URENS; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0002_07da46df-30c7-4944-b2ca-867a60dab300 59667-0002 HUMAN OTC DRUG Thrush Nipples Baptisia, Bryonia, Borax, Candida A, Calendula, Hydrastis, Kali Chloricum, Mercurius Sol, Nat Mur, Nux Moschata, Nux Vomica, Phosphorus, Saccharum Album, Sulphuricum Acidum, Staphysagria, SPRAY ORAL 20130805 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CANDIDA ALBICANS; DELPHINIUM STAPHISAGRIA SEED; GOLDENSEAL; MERCURIUS SOLUBILIS; NUTMEG; PHOSPHORUS; POTASSIUM CHLORATE; SODIUM BORATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SUCROSE; SULFURIC ACID 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0003_5c46cb33-ccab-44a9-8b8e-d0cda5f99bde 59667-0003 HUMAN OTC DRUG Abundant Milk 2 Belladonna, Bryonia, Chelidonium, Cinchona Officionalis, Coffea Cruda, Ignatia, Formalinum, Lac Defloratum, Lac Vaccini Flos, Lecithinum, Phosphorus, Phytolacca, Secale, SPRAY ORAL 20130815 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARABICA COFFEE BEAN; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CLAVICEPS PURPUREA SCLEROTIUM; COW MILK FAT; EGG PHOSPHOLIPIDS; FORMALDEHYDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SKIM MILK; STRYCHNOS IGNATII SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0010_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0010 HUMAN OTC DRUG Tummy Aches and Gas Arsenicum Album, Carbo Veg, Colocynthis, Chamomilla, Dioscorea, Ipecac, Mag. Phos, Sulphur SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACTIVATED CHARCOAL; ARSENIC ACID; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; IPECAC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; SULFUR 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0011_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0011 HUMAN OTC DRUG UTI and Kidney Stones Apis, Berberis Vulgaris, Bryonia, Cantharis, Staphysaria, Sarsaparilla, Urtica Urens SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; DELPHINIUM STAPHISAGRIA SEED; LYTTA VESICATORIA; SARSAPARILLA; URTICA URENS 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0012_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0012 HUMAN OTC DRUG Nausea, Vomiting and Diarrhea Arsenicum Album, Bryonia, Cinchona, Colocynthis, Ipecac, Nux Vomica, Phosphorous, Veratrum Album SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARSENIC ACID; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; PHOSPHORUS; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0013_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0013 HUMAN OTC DRUG Bug Bites and Stings Aconite, Apis, Cantharis, Carbolicum Acidum, Hypericum, Lachesis, Ledum, Staphysagria, Urtica Urens SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; APIS MELLIFERA; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LYTTA VESICATORIA; PHENOL; URTICA URENS 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0014_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0014 HUMAN OTC DRUG Infected Cuts and Punctures Arnica, Apis, Hepar Sulph, Hypericum, Ledum, Silicea SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics APIS MELLIFERA; ARNICA MONTANA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; SILICON DIOXIDE 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0015_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0015 HUMAN OTC DRUG Cuts and Scrapes Aconite, Arnica, Calendula, Hypericum, Silicea SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; SILICON DIOXIDE 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0016_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0016 HUMAN OTC DRUG Burns Arnica, Cantharis, Calendula, Causticum, Hypericum, Urtica Urens SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; HYPERICUM PERFORATUM; LYTTA VESICATORIA; URTICA URENS 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0017_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0017 HUMAN OTC DRUG Blunt Trauma Aconite, Arnica, Calendula, Hypericum, Ledum, Ruta Grav. SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0018_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0018 HUMAN OTC DRUG Head Injury conite, Arnica, Belladonna, Badiaga, Helleborus, Hypericum Nat Sulph SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; HELLEBORUS NIGER ROOT; HYPERICUM PERFORATUM; SODIUM SULFATE; SPONGILLA LACUSTRIS 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0019_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0019 HUMAN OTC DRUG Sprains, Strains and Fractures Aconite, Arnica, Calcarea Carb. Calcarea Phosphorica, Carbolicum Acidum, Hepar Sulph, Hypericum, Rhus Tox, Ruta Graveolens, Symphytum SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARNICA MONTANA; CALCIUM SULFIDE; COMFREY ROOT; HYPERICUM PERFORATUM; PHENOL; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0020_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0020 HUMAN OTC DRUG Mild Earaches and Teething Aconite, Belladonna, Chamomilla, Ferrum Phosphorica, Hepar Sulph, Plantago, Pulsatilla SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ATROPA BELLADONNA; CALCIUM SULFIDE; FERROSOFERRIC PHOSPHATE; MATRICARIA RECUTITA; PLANTAGO MAJOR; PULSATILLA VULGARIS 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0021_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0021 HUMAN OTC DRUG Eye Injuries and Infections Aconite, Arnica, Belladonna, Euphrasia, Gelsemium, Hypericum, Rhus Tox, Symphytum SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; COMFREY ROOT; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0022_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0022 HUMAN OTC DRUG Headaches Arnica, Apis, Bryonia, Belladonna, Gelsemium, Lachesis, Lycopodium, Magnesia Phosphorica, Natrum Muriaticum SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0023_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0023 HUMAN OTC DRUG Toothaches and Abscess Arnica, Belladonna, Calcarea Phosphorica, Chamomilla, Hepar Sulph, Hypericum, Mercurius SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; ATROPA BELLADONNA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURY; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0024_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0024 HUMAN OTC DRUG Migraines Asafeotida 30c, Cannabis Indica 30c, Cannabis Sativa 30c, Coffea Cruda 30c, Helleborus 30c, Ipecac 30c, Iris 30c, Lac Caninum 30c, Mentha Piperita 30c, Natrum Sulph 30c, Oleum Animalis 30c, Opium 30c, Phosphoricum Acidum 30c, Psorinum 30c, Sanguinaria 30c, Senecio 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARABICA COFFEE BEAN; ASAFETIDA; CANIS LUPUS FAMILIARIS MILK; CANNABIS SATIVA SUBSP. INDICA TOP; CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP; CERVUS ELAPHUS HORN OIL; HELLEBORUS FOETIDUS ROOT; IPECAC; IRIS VERSICOLOR ROOT; MENTHA PIPERITA; OPIUM; PHOSPHORIC ACID; SANGUINARIA CANADENSIS ROOT; SCABIES LESION LYSATE (HUMAN); SENECIO VULGARIS; SODIUM SULFATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0025_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0025 HUMAN OTC DRUG Sinus Headaches and Infections Calc Sulph 30c, Dulcamara 30c, Euphrasia 30c, Gelsemium 30c, Graphites 30c, Hepar Sulph 30c, Hydrastis 30c, Kali Bich 30c, Kali Iodatum 30c, Lycopodium 30c, Medorrhinum 30c, Mercurius Sol 30c, Nux Vomica 30c, Pulsatilla 30c, Silicea 30c, Thuja 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics CALCIUM SULFATE; CALCIUM SULFIDE; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; GONORRHEAL URETHRAL SECRETION HUMAN; GRAPHITE; HYDRASTIS CANADENSIS WHOLE; LYCOPODIUM CLAVATUM WHOLE; MERCURIUS SOLUBILIS; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PULSATILLA VULGARIS; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0026_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0026 HUMAN OTC DRUG Fever and Flu Aconite 30c, Arsenicum 30c, Baptisia 30c, Belladonna 30c, Bryonia 30c, Chelidonium 30c, Eupatorium 30c, Ferrum Phos 30c, Gelsemium 30c, Influenzinum 30c, Naja 30c, Nux Vomica 30c, Oscillo 30c, Phosphorous 30c, SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARSENIC ACID; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; NAJA NAJA VENOM; PHOSPHORUS; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0027_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0027 HUMAN OTC DRUG Cough and Cold Aconite 30c, Belladonna 30c, Ferrum Phos 30c, Pulsatilla 30c, Spongia 30c, Rumex Crispus 30c, Mercurius 30c, Wyethia 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ATROPA BELLADONNA; FERRUM PHOSPHORICUM; MERCURY; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; WYETHIA HELENIOIDES ROOT 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0028_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0028 HUMAN OTC DRUG Nagging Cough Carbo Veg 30c, Cuprum Metalicum 30c, Mercurius Sol 30c, Phosphorous 30c, Pulsatilla 30c, Stannum Met 30c, Veratrum Album 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACTIVATED CHARCOAL; COPPER; MERCURIUS SOLUBILIS; PHOSPHORUS; PULSATILLA VULGARIS; TIN; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0029_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0029 HUMAN OTC DRUG Croup Aconite 30c, Antimonium Tart 30c, Belladonna 30c, Bromium 30c, Bryonia 30c, Calc Sulph 30c, Drosera 30c, Dulcmara 30c, Hepar Sulph 30c, Iodium 30c, Kali Bich 30c, Lachesis 30c, Nitricum Acidum 30c, Phosphorous 30c, Phytolacca 30c, Sambucus 30c, Spongia 30c, Stramonium SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BROMINE; BRYONIA ALBA ROOT; CALCIUM SULFATE; CALCIUM SULFIDE; DATURA STRAMONIUM; DROSERA ROTUNDIFOLIA; IODINE; LACHESIS MUTA VENOM; NITRIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; SAMBUCUS CANADENSIS FLOWERING TOP; SOLANUM DULCAMARA TOP; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0030_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0030 HUMAN OTC DRUG Allergic Attack Adrenalinum 30c, Apis 30c, Arsenicum 30c, Cat Hair 30c, Cicuta Virosa 30c, House Dust 30c, House Dust Mites 30c, Human Dandruff 30c, Histuminum 6c, Histaminum 200c, Nat Mur 30c, Mixed Pollens 30c, Rhus Tox 30c, Urtica Urens 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics AGROSTIS CAPILLARIS POLLEN; ALNUS GLUTINOSA POLLEN; ALOPECURUS PRATENSIS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; APIS MELLIFERA VENOM; ARRHENATHERUM ELATIUS POLLEN; ARSENIC ACID; ARTEMISIA VULGARIS POLLEN; BETULA PENDULA POLLEN; BRASSICA NAPUS SUBSP. NAPUS POLLEN; BROMUS COMMUTATUS POLLEN; CALLUNA VULGARIS POLLEN; CHENOPODIUM BONUS-HENRICUS POLLEN; CICUTA VIROSA WHOLE; CORYLUS AVELLANA POLLEN; CYNOSURUS CRISTATUS POLLEN; DACTYLIS GLOMERATA POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; EPINEPHRINE; FAGUS SYLVATICA POLLEN; FELIS CATUS DANDER; FESTUCA PRATENSIS POLLEN; FRAXINUS EXCELSIOR POLLEN; HISTAMINE DIHYDROCHLORIDE; HOLCUS LANATUS POLLEN; HOUSE DUST; HUMAN DANDER; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; PLANTAGO MAJOR POLLEN; PLATANUS X ACERIFOLIA POLLEN; POPULUS TREMULA POLLEN; QUERCUS ROBUR POLLEN; RANUNCULUS BULBOSUS POLLEN; SALIX ALBA POLLEN; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF; URTICA DIOICA POLLEN; URTICA URENS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0031_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0031 HUMAN OTC DRUG Food Sensitivities Apis 30c, Arsenicum 30c, Baptisia 30c, Caseinum 30c, Colocynthis 30c, Corn 30c, Food Dye Additives 30c, Food Preservatives 30c, Histaminum 30c, Hyoscyamus 30c, Mixed Nuts 30c, Modified Corn Starch 30c, MSG 30c, Natrum Mur 30c, Phosphorous 30c, Sacharrin 30c, Soy 30c, Strawberry 30c, Uritca Urens 30c, Wheat Gluten 30c, Whole Egg 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ALMOND; AMARANTH; APIS MELLIFERA VENOM; ARSENIC ACID; BAPTISIA TINCTORIA; CASEIN; CITRULLUS COLOCYNTHIS FRUIT PULP; CORN; D&C YELLOW NO. 11; EGG; ENGLISH WALNUT; FD&C YELLOW NO. 5; FD&C YELLOW NO. 6; HISTAMINE DIHYDROCHLORIDE; HYOSCYAMUS NIGER; METHYLPARABEN; MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE); MONOSODIUM GLUTAMATE; PEANUT; PHOSPHORUS; PROPYLPARABEN; SACCHARIN; SODIUM BENZOATE; SODIUM CHLORIDE; SODIUM NITRITE; SOYBEAN; STRAWBERRY; URTICA URENS; WHEAT GLUTEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0032_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0032 HUMAN OTC DRUG Hay Fever Allium Cepa 30c, Arsenicum Iod. 30c, Euphrasia 30c, Gelsemium 30c, Dulcamara 30c, Kali Bich 30c, Sticta 30c, Sabadilla 30c, Wyethia 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ALLIUM CEPA WHOLE; ARSENIC TRIIODIDE; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; LOBARIA PULMONARIA; POTASSIUM DICHROMATE; SCHOENOCAULON OFFICINALE SEED; SOLANUM DULCAMARA TOP; WYETHIA HELENIOIDES ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0033_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0033 HUMAN OTC DRUG Constipation Aloe 30c, Alumina 30c, Arsenicum 30c, Nux Vomica 30c, Calc Carb 30c, Opium 30c, Plumbum 30c, Podophyllum 30c, Pyrethrum 30c, Silicea 30c, Staphysagria 30c, Rheum 30c, Urtica Urens 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ALOE; ALUMINUM OXIDE; ARSENIC ACID; CALCIUM CARBONATE; DELPHINIUM STAPHISAGRIA SEED; LEAD; OPIUM; PODOPHYLLUM; RHEUM OFFICINALE ROOT; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; TANACETUM PARTHENIUM; URTICA URENS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0034_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0034 HUMAN OTC DRUG Chillax Aconite 30c, Arsenicum 30c, Bambusa 30c, Baryta Carb 30c, Calc Carb 30c, Calc Phos 30c, Hyoscyamus 30c, Ignatia 30c, Lilium Tig 30c, Lycopodium 30c, Mag Mur 30c, Nat Mur 30c,Nat Sulph 30c, Nux Vomica 30c, Phosphorous 30c, Sepia 30c, Silicea 30c, Staphysagria 30c, Stramonium SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARSENIC ACID; BAMBUSA BAMBOS WHOLE; BARIUM CARBONATE; CALCIUM CARBONATE; CALCIUM PHOSPHATE; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; HYOSCYAMUS NIGER; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM SULFATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0035_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0035 HUMAN OTC DRUG Back Strain and Injury Arnica 30c, Berberis Vulgaris 30c, Bryonia 30c, Graphites 30c, Hypericum 30c, Kali Carb 30c, Lycopodium 30c, Nat Sulph 30c, Rhus Tox 30c, Ruta Grav 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; GRAPHITE; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; POTASSIUM CARBONATE; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0036_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0036 HUMAN OTC DRUG Reflux and Heartburn Arsenicum 30c, Bryonia 30c, Carbo Animalis 30c, Carbo Veg 30c, Nat Phos 30c, Nux Vomica 30c, Mag Phos 30c, Pulsatilla 30c, Sepia 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACTIVATED CHARCOAL; ARSENIC ACID; BRYONIA ALBA ROOT; CARBO ANIMALIS; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM PHOSPHATE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0037_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0037 HUMAN OTC DRUG Rashes and Hives Anacardium 30c, Apis 30c, Arsenicum 30c, 30c, Astacus 30c, Calc Carb 30c, Calc Sulph 30c, Carboneum Sulph 30c, Causticum 30c, Chloralum 30c, Copaifera 30c, Cortisonum 30c, Dulcamara 30c, Hepar Sulph 30c, Ledum 30c, Nat Mur 30c, Rhus Tox 30c, Sulphur 30c, Uritca Urens 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ANACARDIUM OCCIDENTALE FRUIT; APIS MELLIFERA VENOM; ARSENIC ACID; ASTACUS ASTACUS; CALCIUM SULFATE ANHYDROUS; CALCIUM SULFIDE; CARBON DISULFIDE; CAUSTICUM; CHLORAL HYDRATE; COPAIFERA OFFICINALIS RESIN; CORTISONE ACETATE; LEDUM PALUSTRE TWIG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP; SULFUR; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0038_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0038 HUMAN OTC DRUG Stiff Joints Arsenicum 30c, Bryonia 30c, Carbo Animalis 30c, Caulophyllum 30c, Causticum 30c, Cocculus 30c, Colchicum 30c, Guaiacum 30c, Ledum 30c, Lycopodium 30c, Petroleum 30c, Rhus Tox 30c, Sepia 30c, Silicea 30c, Sulphur SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ANAMIRTA COCCULUS SEED; ARSENIC ACID; BRYONIA ALBA ROOT; CARBO ANIMALIS; CAULOPHYLLUM THALICTROIDES ROOT; CAUSTICUM; COLCHICUM AUTUMNALE BULB; GUAIACUM OFFICINALE RESIN; KEROSENE; LEDUM PALUSTRE TWIG; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0039_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0039 HUMAN OTC DRUG Joint Pain Anacardium 30c, Argentum Muriaticum 30c, Arnica 30c, Aurum Met 30c, Bryonia 30c, Calc Phos. 30c, Capsicum 30c, Causticum 30c, Euphrasia 30c, Hydrofluoricum Acidum 30c, Nitricum Acidum 30c, Nux Vomica 30c, Plumbum Met. 30c, Rhus Tox 30c, Ruta Grav 30c, Staphysagria 30c, Valeriana 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ANACARDIUM OCCIDENTALE FRUIT; ARNICA MONTANA; BRYONIA ALBA ROOT; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; CAPSICUM; CAUSTICUM; DELPHINIUM STAPHISAGRIA SEED; EUPHRASIA STRICTA; GOLD; HYDROFLUORIC ACID; LEAD; NITRIC ACID; RUTA GRAVEOLENS FLOWERING TOP; SILVER CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0040_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0040 HUMAN OTC DRUG Early Menopause Absinthium 30c, Aurum Met. 30c, Bambusa 30c, Baryta Carb 30c, Baryta Mur 30c, Carboneum Sulph 30c, Conium 30c, Dulcamara 30c, Euphrasia 30c, Ferrum Iodatum 30c, Graphites 30c, Ignatia 30c, Iodium 30c, Kali Carb 30c, Lycopodium 30c, Pulsatilla 30c, Senecio 30c, Sepia 30c, Silicea 30c, Sabal 30c, Sulphur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics BAMBUSA BAMBOS WHOLE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CARBON DISULFIDE; CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; FERROUS IODIDE; GOLD; GRAPHITE; IODINE; LYCOPODIUM CLAVATUM SPORE; PACKERA AUREA; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SAW PALMETTO; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; STRYCHNOS IGNATII SEED; SULFUR; WORMWOOD 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0041_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0041 HUMAN OTC DRUG Healing After Surgery Aceticum Acidum 30c, Aconite 30c, Arnica 30c, Allium Cepa 30c, Belladonna 30c, Calendula 30c, Hepar Sulph 30c, Hypericum 30c, Phosphorous 30c, Pyrogenium 30c, Silicea 30c, Staphysagria SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACETIC ACID; ACONITUM NAPELLUS; ALLIUM CEPA WHOLE; ARNICA MONTANA; ATROPA BELLADONNA; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM; PHOSPHORUS; RANCID BEEF; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0042_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0042 HUMAN OTC DRUG Severe Back Pain Arsenicum 30c, Belladonna 30c, Bryonia 30c, Carbo Animalis 30c, Cinchona 30c, Cina 30c, Colocynthis 30c, Graphites 30c, Ignatia 30c, Lycopodium 30c, Nat Mur 30c, Nitricum Acidum 30c, Rhus Tox SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARSENIC ACID; ARTEMISIA CINA PRE-FLOWERING TOP; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CARBO ANIMALIS; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0043_447b865d-8489-4580-b712-73e016fea921 59667-0043 HUMAN OTC DRUG Nausea and Vomiting aconite 30c, arsenicum album 30c, asarum 30c, conium mac 30c, ipecac 30c, kreosotum 30c, lacticum acidum 30c, medorrhinum 30c, nat mur 30c, nux moschata 30c, nux vomica 30c, phosphorus 30c, pulsatilla 30c, sepia 30c, tobacum 30c, nicotinum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARSENIC ACID; ASARUM CANADENSE ROOT; CONIUM MACULATUM FLOWERING TOP; GONORRHEAL URETHRAL SECRETION HUMAN; IPECAC; LACTIC ACID, DL-; NICOTINE; NUTMEG; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; WOOD CREOSOTE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0044_447b865d-8489-4580-b712-73e016fea921 59667-0044 HUMAN OTC DRUG Water Retention and High BP Apis, Arsenicum, Crotalis Hor 30c, Digitalis 30c, Helonias 30c, Kali Chlor 30c,, Lachesis 30c, Lycopodium 30c, Mercurius Corr. 30c, Nat Mur30c, Phosphorus 30c, Veratrum Vir 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics APIS MELLIFERA VENOM; ARSENIC ACID; CHAMAELIRIUM LUTEUM ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; PHOSPHORUS; POTASSIUM CHLORATE; SODIUM CHLORIDE; VERATRUM VIRIDE ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0045_447b865d-8489-4580-b712-73e016fea921 59667-0045 HUMAN OTC DRUG Breech Baby Ignatia 30c, Nat Mur 30c, Pulsatilla 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0046_447b865d-8489-4580-b712-73e016fea921 59667-0046 HUMAN OTC DRUG Back Labor Cimicifuga 30c, Coffea Cruda 30c, Causticum 30c, Kali Carb 30c, Nux Vomica 30c Petroleum 30c, Sepia 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARABICA COFFEE BEAN; BLACK COHOSH; CAUSTICUM; PETROLATUM; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0047_447b865d-8489-4580-b712-73e016fea921 59667-0047 HUMAN OTC DRUG Labor Exhaustion Arnica 30c, Belladonna 30c, Carbo Veg 30c, Caulophyllum 30c, Cimicifuga 30c, Gelsemium 30c, Kali Carb 30c, Kali Phos 30c , Nat Mur 30c, Opium 30c, Pulsatilla 30c, Secale 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACTIVATED CHARCOAL; ARNICA MONTANA; ATROPA BELLADONNA; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; CLAVICEPS PURPUREA SCLEROTIUM; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; SODIUM CHLORIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0048_447b865d-8489-4580-b712-73e016fea921 59667-0048 HUMAN OTC DRUG PPH Prevention Arnica, Bellis SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; BELLIS PERENNIS 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0049_447b865d-8489-4580-b712-73e016fea921 59667-0049 HUMAN OTC DRUG PPH Cinchona, Cinnamomum SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics CINCHONA OFFICINALIS BARK; CINNAMON 30; 200 [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0050_447b865d-8489-4580-b712-73e016fea921 59667-0050 HUMAN OTC DRUG Baby Respiration Aconite, Antimonium Tart , Arnica , Carbo Veg SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ACTIVATED CHARCOAL; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0051_447b865d-8489-4580-b712-73e016fea921 59667-0051 HUMAN OTC DRUG After Pains and Tears Arnica 30c, Apis 30c, Belladonna 30c, Calendula 30c, Caulophyllum 30c, Chamomilla 30c, Cimicifuga 30c, Ferrum Met. 30c, Kali Carb 30c, Sabina 30c, Secale 30c, Viburnum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics APIS MELLIFERA VENOM; ARNICA MONTANA; ATROPA BELLADONNA; BLACK COHOSH; CALENDULA OFFICINALIS FLOWERING TOP; CAULOPHYLLUM THALICTROIDES ROOT; CLAVICEPS PURPUREA SCLEROTIUM; IRON; JUNIPERUS SABINA LEAFY TWIG; MATRICARIA RECUTITA; POTASSIUM CARBONATE; VIBURNUM OPULUS BARK 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0052_447b865d-8489-4580-b712-73e016fea921 59667-0052 HUMAN OTC DRUG Postpartum Issues Agnus Castus 30c, Cimicifuga 30c, Nat Mur 30c, Platina 30c, Pulsatilla 30c, Sepia 30c, Sulphur 30c, Tarentula 30c Veratrum Vir 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics BLACK COHOSH; CHASTE TREE; LYCOSA TARANTULA; PLATINUM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; SULFUR; VERATRUM VIRIDE ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0053_447b865d-8489-4580-b712-73e016fea921 59667-0053 HUMAN OTC DRUG Infection Arnica 30c, Hepar Sulph 30c, Kali Mur 30c, Silicea SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; CALCIUM SULFIDE; POTASSIUM CHLORIDE; SILICON DIOXIDE 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0054_447b865d-8489-4580-b712-73e016fea921 59667-0054 HUMAN OTC DRUG Low Iron Calcarea Phos. Cinchona, Ferrum Phos, Nat Mur SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ANHYDROUS DIBASIC CALCIUM PHOSPHATE; CINCHONA OFFICINALIS BARK; FERROSOFERRIC PHOSPHATE; SODIUM CHLORIDE 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0055_447b865d-8489-4580-b712-73e016fea921 59667-0055 HUMAN OTC DRUG Loss, Grief and Depression Aurum 30c, Ignatia 30c, Nat Mur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics GOLD; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0056_447b865d-8489-4580-b712-73e016fea921 59667-0056 HUMAN OTC DRUG Boob Ease Belladonna 30c, Bryonia 30c, Calendula 30c, Chamomilla 30c, Colchicum 30c, Graphites 30c, Hepar Sulph 30c, Phytolacca 30c Pulsatilla 30c, Silicea 30c, Urtica Urens SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; COLCHICUM AUTUMNALE SEED; GRAPHITE; MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SILICON DIOXIDE; URTICA URENS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0057_447b865d-8489-4580-b712-73e016fea921 59667-0057 HUMAN OTC DRUG Bfing Aversion Arnica 30c, Aurum Nat Mur 30c, Bambusa 30c, Calc phos, Chamomilla 30c, Kali Bromatum 30c, Lilium Tig 30c, Nitricum Acidum 30c, Secale 30c, Silicea 30c, Sepia 30c, Phosphorous 30c, Platina 30 SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; BAMBUSA BAMBOS WHOLE; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; CLAVICEPS PURPUREA SCLEROTIUM; LILIUM LANCIFOLIUM WHOLE FLOWERING; MATRICARIA RECUTITA; NITRIC ACID; PHOSPHORUS; PLATINUM; POTASSIUM BROMIDE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM TETRACHLOROAURATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0058_447b865d-8489-4580-b712-73e016fea921 59667-0058 HUMAN OTC DRUG Sore Nipples Arnica 30c, Borax 30c Calc Carb 30c, Calendula 30c, Castor Eq 30c, Chamomilla 30c, Croton Tig 30c, Hamamelis 30c, Helonias 30c, Ignatia 30c, Merc Cor 30c, Nux Vomica 30c, Phytolacca 30c, Pulsatilla 30c, Ratanhia 30c, Silicea 30c, Sulphur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; CASTOR OIL; CHAMAELIRIUM LUTEUM ROOT; CROTON TIGLIUM SEED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MATRICARIA RECUTITA; MERCURIC CHLORIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM BORATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0059_447b865d-8489-4580-b712-73e016fea921 59667-0059 HUMAN OTC DRUG Yummy Mummy Milk Aethusa 30c, Antimonium Crudum 30c, Calcarea Carb 30c, Calcarea Phos 30c, Chamomilla 30c, Ferrum Phos 30c, Kali Bich 30c, Natrum Carb 30c, Phosphoricum Acidum 30c, Rheum 30c, Silicea 30c, Valeriana 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; ATROPA BELLADONNA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; MERCURY; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0060_e453932f-7a53-4732-81fd-f053440be1aa 59667-0060 HUMAN OTC DRUG Menstrual Cramps Back Ammonium Carb 30c, Borax 30c, Calcarea Phosphorica 30c, Chamomilla 30c, Cimicifuga 30c, Gelsemium 30c, Helonius 30c, Kali Carb 30c, Nux Vomica 30c Pulsatilla 30c, Senecio 30c, Xanthum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics AMMONIUM CARBONATE; BLACK COHOSH; CHAMAELIRIUM LUTEUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA RECUTITA; PACKERA AUREA; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SODIUM BORATE; STRYCHNOS NUX-VOMICA SEED; TRIBASIC CALCIUM PHOSPHATE; ZANTHOXYLUM AMERICANUM BARK 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0061_e453932f-7a53-4732-81fd-f053440be1aa 59667-0061 HUMAN OTC DRUG Menstrual Cramps Front Ammonium Mur 30c, Belladonna 30c, Cactus 30c, Caladium 30c, Calc Phos 30c, Caulophyllum 30c, Chamomilla 30c, Cocculus 30c, Conium 30c, Gelsemium 30c, Ignatia 30c, Mag Mur 30c, Nux Vomica 30c, Platina 30c, Sepia 30c Tarentula 30c, Viburnum 30c, Ustillago 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics AMMONIUM CHLORIDE; ANAMIRTA COCCULUS SEED; ATROPA BELLADONNA; CAULOPHYLLUM THALICTROIDES ROOT; CONIUM MACULATUM FLOWERING TOP; DIEFFENBACHIA SEGUINE; GELSEMIUM SEMPERVIRENS ROOT; LYCOSA TARANTULA; MAGNESIUM CHLORIDE; MATRICARIA RECUTITA; PLATINUM; SELENICEREUS GRANDIFLORUS STEM; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TRIBASIC CALCIUM PHOSPHATE; USTILAGO MAYDIS; VIBURNUM OPULUS BARK 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0062_e453932f-7a53-4732-81fd-f053440be1aa 59667-0062 HUMAN OTC DRUG Scanty Flow Agnus 30c, Argentum Nitricum 30c, Cinchona 30c, Conium 30c, Dioscorea 30c, Gelsemium 30c, Lycopodium 30c, Phosphoricum Acidum 30c, Nux Vomica 30c, Sabal 30c, Seleninum 30c, Staphysagria 30c, Strychninum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics CHASTE TREE; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; DIOSCOREA VILLOSA TUBER; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SAW PALMETTO; SELENIUM; SILVER NITRATE; STRYCHNINE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0063_e453932f-7a53-4732-81fd-f053440be1aa 59667-0063 HUMAN OTC DRUG Heavy Flow Aletris 30c, Belladonna 30c, Bovista 30c, Cinchona 30c, Colocynthis 30c, Chamomilla 30c, Cinnamomum 30c, Coffea Cruda 30c, Secale 30c, Veratrum Album 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ALETRIS FARINOSA ROOT; ARABICA COFFEE BEAN; ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; CINNAMON; CITRULLUS COLOCYNTHIS FRUIT PULP; CLAVICEPS PURPUREA SCLEROTIUM; GIANT PUFFBALL; MATRICARIA RECUTITA; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0064_e453932f-7a53-4732-81fd-f053440be1aa 59667-0064 HUMAN OTC DRUG PCOS Apis 30c, Aurum Nat Mur 30c, Calc Fluor 30c, Nat Sulph 30c, Palladium 30c, Silicea 30c, Sabal 30c, Thuja 30c, Ustillago 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics APIS MELLIFERA VENOM; CALCIUM FLUORIDE; PALLADIUM; SAW PALMETTO; SILICON DIOXIDE; SODIUM SULFATE; SODIUM TETRACHLOROAURATE; THUJA OCCIDENTALIS LEAFY TWIG; USTILAGO MAYDIS 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0065_e453932f-7a53-4732-81fd-f053440be1aa 59667-0065 HUMAN OTC DRUG Bloating Bovista 30c, Carbo Veg 30c, Cinchona 30c, Cocculus 30c, Graphites 30c, Kali Carb 30c, Lachesis 30c, Lycopodium 3c, Nat Carb 30c, Pulsatilla 30c, Sulphur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACTIVATED CHARCOAL; ANAMIRTA COCCULUS SEED; CINCHONA OFFICINALIS BARK; GIANT PUFFBALL; GRAPHITE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SODIUM CARBONATE; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0066_e453932f-7a53-4732-81fd-f053440be1aa 59667-0066 HUMAN OTC DRUG Hormonal Headaches Belladonna 30c, Cinchona 30c, Ferrum Phos 30c, Gelsemium 30c, Glonoine 30, Lachesis 30c, Nat Mur 30c, Nux Vomica 30c, Sanguinaria 30c, Sepia 30c, Sulphur 30c, Tarentula 30c, Ustillago 30c, Veratrum Album 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; LYCOSA TARANTULA; NITROGLYCERIN; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR; USTILAGO MAYDIS; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0067_e453932f-7a53-4732-81fd-f053440be1aa 59667-0067 HUMAN OTC DRUG Tender Breasts Bryonia 30c, Calc Carb 30c, Conium Mac 30c, Helonius 30c, Iodium 30c, Lac Can 30c, Phytolacca 30c, Pulsatilla 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics BRYONIA ALBA ROOT; CANIS LUPUS FAMILIARIS MILK; CHAMAELIRIUM LUTEUM ROOT; CONIUM MACULATUM FLOWERING TOP; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0068_e453932f-7a53-4732-81fd-f053440be1aa 59667-0068 HUMAN OTC DRUG Mood Swings Aconite 30c, Belladonna 30c, Chamomilla 30c, Cimicifuga 30c, Ignatia 30c, Lachesis 30c, Pulsatilla 30c, Sepia 30c, Nux Vomica 30c Sulphur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS ROOT; ATROPA BELLADONNA; BLACK COHOSH; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0069_e453932f-7a53-4732-81fd-f053440be1aa 59667-0069 HUMAN OTC DRUG Baby Dust Agnus C. 30c, Borax 30c, Condurango 30c, Graphites 30c, Iodium 30c, Medorrhinum 30c, Nat Mur 30c, Platina 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics CHASTE TREE; GONORRHEAL URETHRAL SECRETION HUMAN; GRAPHITE; IODINE; MARSDENIA CONDURANGO BARK; PLATINUM; SODIUM BORATE; SODIUM CHLORIDE 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0070_e453932f-7a53-4732-81fd-f053440be1aa 59667-0070 HUMAN OTC DRUG Sticky Baby Dust Aconite 30c, Arnica 30c, Belladonna 30c, Baptisia 30c, Chamomilla 30c, Caulophylum 30c, Cinnamomum 30c, Eupatorium 30c, Phosphorous30c, Pulsatilla 30c, Sabina 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; CAULOPHYLLUM THALICTROIDES ROOT; CINNAMON; EUPATORIUM PERFOLIATUM FLOWERING TOP; JUNIPERUS SABINA LEAFY TWIG; MATRICARIA RECUTITA; PHOSPHORUS; PULSATILLA VULGARIS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0071_e453932f-7a53-4732-81fd-f053440be1aa 59667-0071 HUMAN OTC DRUG Rainbow Baby Aletris 30c, Calc Carb 30c, Cimicifuga 30c, Caulophyllum 30c, Helonius 30c, Kali Carb. 30c, Sabina 30c, Secale 30c, Viburnum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ALETRIS FARINOSA ROOT; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; CLAVICEPS PURPUREA SCLEROTIUM; JUNIPERUS SABINA LEAFY TWIG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; VIBURNUM OPULUS BARK 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0072_e453932f-7a53-4732-81fd-f053440be1aa 59667-0072 HUMAN OTC DRUG Ovulation Boost Agnus 30c, Aurum Nat Mur. 30c, Aletris 30c, Dioscorea 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ALETRIS FARINOSA ROOT; CHASTE TREE; DIOSCOREA VILLOSA TUBER; SODIUM TETRACHLOROAURATE 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0073_e453932f-7a53-4732-81fd-f053440be1aa 59667-0073 HUMAN OTC DRUG Hot Flashes Belladonna 30c, Calc Phos 30c, Ferrum Phos 30c, Glonoine 30c, Lachesis 30c, Sanguinaria 30c Sepia 30c, Sulphur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ATROPA BELLADONNA; FERROSOFERRIC PHOSPHATE; LACHESIS MUTA VENOM; NITROGLYCERIN; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SULFUR; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0075_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0075 HUMAN OTC DRUG Tantrums and Whining Arsenicum 30c, Belladonna 30c, Calc Phos 30c, Chamomilla 30c, Cina 30c, Ignatia 30c, Pulsatilla 30c, Nat Mur 30c, Nux Vomica 30c, Thuja 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARSENIC ACID; ARTEMISIA CINA PRE-FLOWERING TOP; ATROPA BELLADONNA; MATRICARIA RECUTITA; PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0076_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0076 HUMAN OTC DRUG Kicking and Screaming Apis 30c, Anacardium 30c, Belladonna 30c, Borax 30c, Calc Phos 30c, Chamomilla 30c, Cina 30c, Ipecac 30c, Kali Carb, Lac Can 30c, Stramoniumn 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics APIS MELLIFERA VENOM; ARTEMISIA CINA PRE-FLOWERING TOP; ATROPA BELLADONNA; CANIS LUPUS FAMILIARIS MILK; DATURA STRAMONIUM; IPECAC; MATRICARIA RECUTITA; POTASSIUM CARBONATE; SEMECARPUS ANACARDIUM JUICE; SODIUM BORATE; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0077_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0077 HUMAN OTC DRUG Hair Pulling Arsenicum 30c, Belladonna 30c, Cina 30c, Cuprum 30c, Lillium 30c Tarentula 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARSENIC TRIOXIDE; ARTEMISIA CINA PRE-FLOWERING TOP; ATROPA BELLADONNA; COPPER; LILIUM LANCIFOLIUM FLOWERING TOP; LYCOSA TARANTULA 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0078_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0078 HUMAN OTC DRUG Pinching and Biting Belladonna 30c, Calc Carb 30c, Cantharis 30c, Chamomilla 30c, Coffea Cruda 30c, Cuprum 30c, Lachesis 30c, Hyoscyamus 30c, Phytolacca 30c, Stramonium 30c, Veratrum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARABICA COFFEE BEAN; ATROPA BELLADONNA; COPPER; DATURA STRAMONIUM; HYOSCYAMUS NIGER; LACHESIS MUTA VENOM; LYTTA VESICATORIA; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0079_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0079 HUMAN OTC DRUG Throwing and Hitting Belladonna 30c, Colocynthis 30c Dulcamara 30c, Hyoscyamus 30c, Lillium 30c, Nux Vomica 30c, Staphysagria 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ATROPA BELLADONNA; CITRULLUS COLOCYNTHIS FRUIT PULP; DELPHINIUM STAPHISAGRIA SEED; HYOSCYAMUS NIGER; LILIUM LANCIFOLIUM FLOWERING TOP; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0080_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0080 HUMAN OTC DRUG Attention Span Aconite 30c, Aesculus 30c, Belladonna 30c, Bovista 30c, Hepar Sulph 30c, Hyoscyamus 30c, Ignatia 30c, Silicea 30c, Sticta 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; CALCIUM SULFIDE; GIANT PUFFBALL; HYOSCYAMUS NIGER; LOBARIA PULMONARIA; SILICON DIOXIDE; STRYCHNOS IGNATII SEED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0081_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0081 HUMAN OTC DRUG Sibling Jealousy Arsenicum 30c, Calcarea Carb 30c, Chamomilla 30c, Hyoscyamus 30c, Ignatia 30c, Lachesis 30c, Pulsatilla 30c, Sepia 30c, Nux Vomica 30c, Natrum Mur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARSENIC TRIOXIDE; HYOSCYAMUS NIGER; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0082_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0082 HUMAN OTC DRUG Loud Child Arnica 30c, Belladonna 30c,Hyoscyamus 30c, Lachesis 30c, Nux Moschata 30c, Silicea 30c, Sepia 30c, Stramonium 30c, Sulphur 30c, Veratrum Album 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; ATROPA BELLADONNA; DATURA STRAMONIUM; HYOSCYAMUS NIGER; LACHESIS MUTA VENOM; NUTMEG; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0083_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0083 HUMAN OTC DRUG Speech Therapy Agaricus 30c, Belladonna 30c, Hyoscyamus 30c, Kali Brom 30c, Natrum Mur 30c, Nux Vomica 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics AMANITA MUSCARIA FRUITING BODY; ATROPA BELLADONNA; HYOSCYAMUS NIGER; POTASSIUM BROMIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0084_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0084 HUMAN OTC DRUG Growing Pains Calc Carb 30c, Calc Phos 30c, Eupatorium 30c, Guaicum 30c, Phosphoricum Acidum 30c, Ruta Grav 30c, SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; GUAIAC; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; RUTA GRAVEOLENS FLOWERING TOP 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0085_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0085 HUMAN OTC DRUG Hypersensitivity Aconite 30c, Aurum Nat Mur 30c, Belladonna 30c, Chamomilla 30c, Gelseium 30c, Kali Phos 30c, Phosphorous, Pulsatilla 30c, Staphysagria 30, Teucrium 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ATROPA BELLADONNA; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA RECUTITA; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; SODIUM TETRACHLOROAURATE; TEUCRIUM MARUM 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0086_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0086 HUMAN OTC DRUG Peepsing Argentum 30c, Belladonna 30c, Causticum 30c, Cina 30c, Equisetum 30c, Kreosotum 30c, Lycopodium 30c, Nux Vomica 30c, Sepia 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARTEMISIA CINA PRE-FLOWERING TOP; ATROPA BELLADONNA; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; WOOD CREOSOTE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0087_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0087 HUMAN OTC DRUG Night Terrors Borax 30c, Calc Carb 30c, Capsicum 30c, Chamomilla 30c, Cina 30c, Lac Can 30c, Kali Bromatum 30c, Stramonium 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARTEMISIA CINA PRE-FLOWERING TOP; CANIS LUPUS FAMILIARIS MILK; CAPSICUM; DATURA STRAMONIUM; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM BROMIDE; SODIUM BORATE 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0088_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0088 HUMAN OTC DRUG Nighty Night Argentum 30c, Arsenicum 30c, Belladonna 30c, Calc Phos 30c, Chelidonium 30c, Coffea 30c, Lillium 30c, Podophyllum 30c Pulsatilla 30c, Rhus Tox 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CHELIDONIUM MAJUS; LILIUM LANCIFOLIUM WHOLE FLOWERING; PODOPHYLLUM; PULSATILLA VULGARIS; SILVER NITRATE; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0089_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0089 HUMAN OTC DRUG Asthma Abies Canadensis 30c, Adrenalinum 30c, Ammi Visnaga 30c, Cat Hair 30c, Eriodictyon 30c, Eucalyptus Glob 30c, Human Dandruff 30c, House Dust Mites 30c, Okoubaka 30c, Origanum 30c, Melissa Officionalis 30c Myrtus Communis 30c Mentha Pepperita 30c, Pinus Sylvestris. 30c, SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics AMMI VISNAGA FRUIT; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; EPINEPHRINE; ERIODICTYON CALIFORNICUM LEAF; EUCALYPTUS GLOBULUS LEAF; FELIS CATUS HAIR; HUMAN DANDER; MELISSA OFFICINALIS; MENTHA PIPERITA; MYRTUS COMMUNIS TOP; OKOUBAKA AUBREVILLEI BARK; ORIGANUM MAJORANA WHOLE; PINUS SYLVESTRIS LEAFY TWIG; TSUGA CANADENSIS BARK 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0090_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0090 HUMAN OTC DRUG Whooping Cough 2 Aconite 30c, Ambrosia 30c, Castanea Sativa 30c, Chelidonium 30c, Cuprum Aceticum 30c, Dulcamara 30c, Hepar Sulph 30c, Hydrocyanicum 30c, Hyoscyamus 30c, Kali Bich 30c Kali Mur 30c Lobelia30c, Mag Phos. 30c, Naphtha 30c, Sepia 30c, Trifolium 30c, Justicia 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; AMBROSIA ARTEMISIIFOLIA; CALCIUM SULFIDE; CASTANEA SATIVA FLOWER; CHELIDONIUM MAJUS; CUPRIC ACETATE; HYDROGEN CYANIDE; HYOSCYAMUS NIGER; JUSTICIA ADHATODA LEAF; LOBELIA INFLATA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; NAPHTHALENE; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; SEPIA OFFICINALIS JUICE; SOLANUM DULCAMARA TOP; TRIFOLIUM PRATENSE FLOWER 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0091_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0091 HUMAN OTC DRUG Difficult Expectoration antimonium tart 30c, arsenicum 30c, belladonna 30c, bacillinum 200c, calcarea carb 30c, cactus 30c, causticum 30c, cuprum met. 30c, dulcamara 30c, ipecac 30c, hepar sulph 30c, kali sulph 30c, lycopodium 30c, natrum carb 30c, nux vomica 30c, phosphorus 30c, pulsatilla 30c, sepia 30c, senega 30c, SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CALCIUM SULFIDE; CAUSTICUM; COPPER; ESCHERICHIA COLI; IPECAC; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POLYGALA SENEGA ROOT; POTASSIUM SULFATE; PULSATILLA VULGARIS; SELENICEREUS GRANDIFLORUS STEM; SEPIA OFFICINALIS JUICE; SODIUM CARBONATE; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0092_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0092 HUMAN OTC DRUG Chest Cold Antimonium Tart 30c, Bacillinum 200c, Bryonia 30c, Camphora 30c, Chelidonoium 30c, Grindelia 30c, Kreosotum 30c, Lycopodium 30c, Natrum Sulph 30c, Phosphorous 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); CHELIDONIUM MAJUS; ESCHERICHIA COLI; GRINDELIA HIRSUTULA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SODIUM SULFATE; WOOD CREOSOTE 30; 30; 30; 30; 200; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0093_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0093 HUMAN OTC DRUG Bronchitis Aesculos 30c, Antimonium Tart 30c, Arsenicum 30c, Baryta Mur 30c, Bryonia 30c, Causticum 30c, Dulcamara 30c, Hepar Sulph. 30c, Phosphorous 30c, Sanguinaria 30c , Senicio 30c, Stannum Met 30c, Sulphur 30c, Quebracho 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; BARIUM CHLORIDE DIHYDRATE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAUSTICUM; HORSE CHESTNUT; PHOSPHORUS; SANGUINARIA CANADENSIS ROOT; SENECIO VULGARIS; SOLANUM DULCAMARA TOP; SULFUR; TIN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0094_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0094 HUMAN OTC DRUG Whooping Cough Antimonium Tart 30c, Belladonna 30c, Carbo Veg 30c, Cina 30c, Coccus Cacti 30c, Cuprum Met 30c, Dioscorea 30c, Drosera 30c, Formalinum 30c, Ignatia 30c, Ipecac 30c, Kali Brom 30c, Kali Carb 30c, Kali Sulph 30c, Mephitis 30c, Nux Vomica 30c Pertussinum 30c, Pulsatilla 30c Veratrum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACTIVATED CHARCOAL; ANTIMONY POTASSIUM TARTRATE; ARTEMISIA CINA PRE-FLOWERING TOP; BRYONIA ALBA ROOT; COPPER; DIOSCOREA VILLOSA TUBER; DROSERA ROTUNDIFOLIA; FORMALDEHYDE; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; IPECAC; MEPHITIS MEPHITIS ANAL GLAND FLUID; POTASSIUM BROMIDE; POTASSIUM CARBONATE; POTASSIUM SULFATE; PROTORTONIA CACTI; PULSATILLA VULGARIS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0095_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0095 HUMAN OTC DRUG Wet Weather Asthma Arnica 30c, Belladonna 30c,Hyoscyamus 30c, Lachesis 30c, Nux Moschata 30c, Silicea 30c, Sepia 30c, Stramonium 30c, Sulphur 30c, Veratrum Album 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; ATROPA BELLADONNA; DATURA STRAMONIUM; HYOSCYAMUS NIGER; LACHESIS MUTA VENOM; NUTMEG; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0096_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0096 HUMAN OTC DRUG Asthma Allergies Allium Cepa 30c, Arsenicum 30c, Thuja 30c, Badiaga 30c, Carbo Veg 30c, Dulcamara 30c, Euphrasia 30c, Iodatum 30c, Naja 30c, Nat Sulph 30c, Nux Vomica 30c, Sabadilla 30c, Sinapis Nigra 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; BLACK MUSTARD SEED; EUPHRASIA STRICTA; IODINE; NAJA NAJA VENOM; ONION; SCHOENOCAULON OFFICINALE SEED; SODIUM SULFATE; SOLANUM DULCAMARA TOP; SPONGILLA LACUSTRIS; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0098_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0098 HUMAN OTC DRUG Strep Throat Arum Tri 30c, Belledonna 30c, Carbo Animalis 30c, Causticum 30c, Echinacea30c, Hydrastis 30c, Lachesis 30c, Phosphorous 30c, Phytolacca 30c, Nitricum Acidum 30c, Nux Vomica 30c, Mercurius Sol 30c , streptococcinum 30c, Sabadilla 30c, Spigellia 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARISAEMA TRIPHYLLUM ROOT; ATROPA BELLADONNA; CARBO ANIMALIS; CAUSTICUM; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; NITRIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SCHOENOCAULON OFFICINALE SEED; SPIGELIA ANTHELMIA; STREPTOCOCCUS PYOGENES; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0099_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0099 HUMAN OTC DRUG Lip and Tongue Tie Revision Artemisia30c, Calendula 30c, Carbolicum Acidum 30c, Hypericum 30c, Staphysagria 30c, Sulphuricum Acidum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARTEMISIA ABROTANUM FLOWERING TOP; CALENDULA OFFICINALIS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM; PHENOL; SULFURIC ACID 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0100_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0100 HUMAN OTC DRUG Tonsillitis Alumen 30c, Baryta Carb 30c, Baryta Mur 30c, Belladonna 30c, Ferrum Phos 30c Guiaicum 30c, Hepar Sulph 30c, Lac Caninum 30c, Lachesis 30c, Merc Sol 30c, Merc Dulcies 30c, Nitricum Acidum 30c, Silicea 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ALUM, POTASSIUM; ATROPA BELLADONNA; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CALCIUM SULFIDE; CALOMEL; CANIS LUPUS FAMILIARIS MILK; FERROSOFERRIC PHOSPHATE; GUAIAC; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; NITRIC ACID; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0101_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0101 HUMAN OTC DRUG Hand Foot Mouth Antimonium Crudum 30c, Argentum Nit 30c, Borax 30c, Kali Chloricum 30c, Mercurius Corr 30c, Nat Mur 30c, Nitricum Ac 30c, Sulphuricum Acidum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ANTIMONY TRISULFIDE; MERCURIC CHLORIDE; NITRIC ACID; POTASSIUM CHLORATE; SILVER NITRATE; SODIUM BORATE; SODIUM CHLORIDE; SULFURIC ACID 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0102_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0102 HUMAN OTC DRUG Ingrown Toenails Causticum 30c, Graphites 30c, Hepar Sulph 30c, Mag Phos 30c, Magnetis Polus Australis 30c, Nat Mur 30c, Nitricum Acidum 30c, Phosphoricum Ac 30c, Silicea 30c, sulphur 30c, Thuja 30c, Teucrium 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics CALCIUM SULFATE; CAUSTICUM; GRAPHITE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; NITRIC ACID; PHOSPHORIC ACID; SILICON DIOXIDE; SODIUM CHLORIDE; SULFUR; TEUCRIUM MARUM; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0103_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0103 HUMAN OTC DRUG Diabetes Aceticum Acidum, Alloxanum, Bovista, Carcinocinum, Helonias, Lycopodium, Phosphoricum Acidum, Phosphorus, Plumbum Met, Tarentula. Syzygium ,Terebinthiniae, Uranium Nit. SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACETIC ACID; ALLOXAN; CHAMAELIRIUM LUTEUM ROOT; GIANT PUFFBALL; HUMAN BREAST TUMOR CELL; LEAD; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED; TURPENTINE OIL; URANYL NITRATE HEXAHYDRATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0104_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0104 HUMAN OTC DRUG Cerebral Palsy Arnica 30c, Causticum 30c, Conium Mac 30c, Gelsemium 30c, Helleborus 30c, Ignatia 30c, Lathyrus 30c, Opium 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA FLOWER; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HELLEBORUS NIGER ROOT; LATHYRUS SATIVAS SEED; OPIUM; STRYCHNOS IGNATII SEED 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0105_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0105 HUMAN OTC DRUG Angry Eyebrows Aconite 30c, Anacardium 30c, Arsenicum 30c, Aurum Met. 30c, Bryonia 30c, Chamomilla 30c, Hepar Sulph 30c, Ignatia 30c, Kali Sulph 30c, Lycopodium 30c, Merc Sol 30c, Nat Mur 30c, Nitricum Acidum 30c, Nux Vomica 30c, Petroleum 30c, Sepia 30c, Staphysagria 30c, Sulphur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM SULFIDE; DELPHINIUM STAPHISAGRIA SEED; GOLD; KEROSENE; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; NITRIC ACID; POTASSIUM SULFATE; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0106_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0106 HUMAN OTC DRUG Mellow Out Arsenicum 30c, Chamomilla 30c, Cina 30c, Glononium 30c, Hyoscyamus 30c, Medorrhinum 30c, Stramonium 30c, Tarentula 30c, Veratrum Album 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARSENIC TRIOXIDE; ARTEMISIA CINA PRE-FLOWERING TOP; DATURA STRAMONIUM; GONORRHEAL URETHRAL SECRETION HUMAN; HYOSCYAMUS NIGER; LYCOSA TARANTULA; MATRICARIA RECUTITA; NITROGLYCERIN; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0107_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0107 HUMAN OTC DRUG Absent Minded Androc 30c, Apis 30c, Cannabis Indica 30c, Causticum 30c, Chamomilla 30c, Helleborus 30c, Iridium Met 30c, Lachesis 30c, Mezereum 30c, Nat Mur 30c, Nux Moschata 30c, Platina 30c, Pulsatilla 30c, Sepia 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ANDROCTONUS AUSTRALIS VENOM; APIS MELLIFERA VENOM; CANNABIS SATIVA SUBSP. INDICA TOP; CAUSTICUM; DAPHNE MEZEREUM BARK; HELLEBORUS NIGER ROOT; IRIDIUM; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; NUTMEG; PLATINUM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0108_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0108 HUMAN OTC DRUG Memory Boost Baryta Carb 30c, Carbolicum Acidum 30c, Calc Carb 30c, Calc Phos 30c, Chelidonium 30c, Carboneum Sulph 30c, Hydrastis 30c, Hyoscyamus 30c Lac Can 30c, Nux Moschata 30c, Sulphur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics BARIUM CARBONATE; CANIS LUPUS FAMILIARIS MILK; CARBON DISULFIDE; CHELIDONIUM MAJUS; GOLDENSEAL; HYOSCYAMUS NIGER; NUTMEG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHENOL; SULFUR; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0109_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0109 HUMAN OTC DRUG Stye in the Eye Calc Fluor 30c,, Conium Mac 30c,, Carboneum Sulph 30c, Digitalis 30c, Graphites 30c, Lycopodium 30c, Pulsatilla 30c, Sepia 30c, Silicea 30c, Staphysagria 30c, Sulphur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics CALCIUM FLUORIDE; CARBON DISULFIDE; CONIUM MACULATUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; DIGITALIS; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59667-0110_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0110 HUMAN OTC DRUG Weight Loss Ambra Grisea 30c, Antimonium Crudum 30c, Calc Carb 30c, Capsicum 30c, Ferrum Met 30c, Graphites 30c, Kali Carb 30c, Phytolacca 30c, Sepia SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics AMBERGRIS; ANTIMONY TRISULFIDE; CAPSICUM; GRAPHITE; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; SEPIA OFFICINALIS JUICE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] 59672-0032_aa36b3e2-9cfa-47f0-9559-ed6612e5396d 59672-0032 HUMAN OTC DRUG Arnica Arnica Montana TABLET ORAL 20140307 UNAPPROVED HOMEOPATHIC LC Industries ARNICA MONTANA 30 [hp_C]/1 59672-0116_d9023951-af32-4f16-aced-c101afd6e06c 59672-0116 HUMAN OTC DRUG NO-JET-LAG Lite Arnica Montana, Bellis Perennis, Matricaria Recutita, Ipecac, and Lycopodium Clavatum Spore TABLET ORAL 20110808 UNAPPROVED HOMEOPATHIC Miers Laboratories ARNICA MONTANA; BELLIS PERENNIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 59672-0130_0055b112-9820-4fad-b7e0-58264b97fb60 59672-0130 HUMAN OTC DRUG NO-JET-LAG Arnica Montana, Bellis Perennis, Matricaria Recutita, Ipecac, and Lycopodium Clavatum Spore TABLET ORAL 20110808 UNAPPROVED HOMEOPATHIC LC Industries ARNICA MONTANA; BELLIS PERENNIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 59672-0532_241f2e67-bdc5-4829-8901-2c84929fa5e8 59672-0532 HUMAN OTC DRUG Drink Ease Avena Sativa Flowering Top, Capsicum, Strychnos Nux-Vomica Seed, Veratrum Album Root, and Zinc TABLET ORAL 20120405 UNAPPROVED HOMEOPATHIC LC Industries AVENA SATIVA FLOWERING TOP; CAPSICUM; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT; ZINC 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 59672-0732_977f1de9-3567-4053-ac35-eeb15012f936 59672-0732 HUMAN OTC DRUG TRIP EASE SODIUM BORATE, ANAMIRTA COCCULUS SEED, GELSEMIUM SEMPERVIRENS ROOT, WOOD CREOSOTE, TOXICODENDRON PUBESCENS LEAF, AND TOBACCO LEAF TABLET ORAL 20120504 UNAPPROVED HOMEOPATHIC LC Industries ANAMIRTA COCCULUS SEED; GELSEMIUM SEMPERVIRENS ROOT; SODIUM BORATE; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; WOOD CREOSOTE 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 59672-0916_fa9a0a6f-87e3-4cc5-a0dc-65ceadc10893 59672-0916 HUMAN OTC DRUG NO-WEAK-NAILS GRAPHITE, THUJA OCCIDENTALIS LEAFY TWIG, and SILICON DIOXIDE TABLET ORAL 20140915 UNAPPROVED HOMEOPATHIC LC Industries GRAPHITE; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 59676-101_0993081a-81b0-43c7-a8dc-a21b2f7dcaea 59676-101 HUMAN PRESCRIPTION DRUG OKT3 muromonab-CD3 INJECTION, SOLUTION INTRAVENOUS 19860719 BLA BLA103463 Centocor Ortho Biotech Products, L.P. MUROMONAB-CD3 5 mg/5mL CD3 Blocker Immunosuppressant [EPC],CD3 Receptor Antagonists [MoA],CD3-directed Antibody Interactions [MoA],Decreased Immunologic Activity [PE] 59676-225_e4e3bb61-6c5f-4434-84eb-79d9d6b7ed49 59676-225 HUMAN PRESCRIPTION DRUG OLYSIO simeprevir CAPSULE ORAL 20131122 NDA NDA205123 Janssen Products LP SIMEPREVIR 150 mg/1 Hepatitis C Virus NS3/4A Protease Inhibitor [EPC],HCV NS3/4A Protease Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA] 59676-278_238a88be-004e-4f97-87d8-768c00c918c9 59676-278 HUMAN PRESCRIPTION DRUG EDURANT rilpivirine hydrochloride TABLET, FILM COATED ORAL 20110520 NDA NDA202022 Janssen Products, LP RILPIVIRINE HYDROCHLORIDE 25 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [Chemical/Ingredient] 59676-302_6de66d01-138a-41df-aca5-b2be326de0e2 59676-302 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19890601 BLA BLA103234 Janssen Products, LP ERYTHROPOIETIN 2000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 59676-303_6de66d01-138a-41df-aca5-b2be326de0e2 59676-303 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19890601 BLA BLA103234 Janssen Products, LP ERYTHROPOIETIN 3000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 59676-304_6de66d01-138a-41df-aca5-b2be326de0e2 59676-304 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19890601 BLA BLA103234 Janssen Products, LP ERYTHROPOIETIN 4000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 59676-310_6de66d01-138a-41df-aca5-b2be326de0e2 59676-310 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19890601 BLA BLA103234 Janssen Products, LP ERYTHROPOIETIN 10000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 59676-312_6de66d01-138a-41df-aca5-b2be326de0e2 59676-312 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19890601 BLA BLA103234 Janssen Products, LP ERYTHROPOIETIN 10000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 59676-320_6de66d01-138a-41df-aca5-b2be326de0e2 59676-320 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19890601 BLA BLA103234 Janssen Products, LP ERYTHROPOIETIN 20000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 59676-340_6de66d01-138a-41df-aca5-b2be326de0e2 59676-340 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19890601 BLA BLA103234 Janssen Products, LP ERYTHROPOIETIN 40000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] 59676-562_d4d22972-0dd8-4a95-9a65-9c92891a5638 59676-562 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20080308 NDA NDA021976 Janssen Products LP DARUNAVIR ETHANOLATE 600 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] 59676-563_d4d22972-0dd8-4a95-9a65-9c92891a5638 59676-563 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20090114 NDA NDA021976 Janssen Products LP DARUNAVIR ETHANOLATE 75 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] 59676-564_d4d22972-0dd8-4a95-9a65-9c92891a5638 59676-564 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20090427 NDA NDA021976 Janssen Products LP DARUNAVIR ETHANOLATE 150 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] 59676-565_d4d22972-0dd8-4a95-9a65-9c92891a5638 59676-565 HUMAN PRESCRIPTION DRUG PREZISTA darunavir SUSPENSION ORAL 20111216 NDA NDA202895 Janssen Products LP DARUNAVIR ETHANOLATE 100 mg/mL HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] 59676-566_d4d22972-0dd8-4a95-9a65-9c92891a5638 59676-566 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20121109 NDA NDA021976 Janssen Products LP DARUNAVIR ETHANOLATE 800 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] 59676-570_10c0b502-9857-436d-883f-602b1f684aca 59676-570 HUMAN PRESCRIPTION DRUG Intelence etravirine TABLET ORAL 20080118 NDA NDA022187 Janssen Products LP ETRAVIRINE 100 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] 59676-571_10c0b502-9857-436d-883f-602b1f684aca 59676-571 HUMAN PRESCRIPTION DRUG Intelence etravirine TABLET ORAL 20101222 NDA NDA022187 Janssen Products LP ETRAVIRINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] 59676-572_10c0b502-9857-436d-883f-602b1f684aca 59676-572 HUMAN PRESCRIPTION DRUG Intelence etravirine TABLET ORAL 20120326 NDA NDA022187 Janssen Products LP ETRAVIRINE 25 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] 59676-701_e8194ca3-15e5-4692-b548-d39dc2904397 59676-701 HUMAN PRESCRIPTION DRUG SIRTURO Bedaquiline Fumarate TABLET ORAL 20121228 NDA NDA204384 Janssen Products, LP BEDAQUILINE FUMARATE 100 mg/1 Diarylquinoline Antimycobacterial [EPC],Diarylquinolines [Chemical/Ingredient] 59676-960_d322bcbe-8d07-4cd2-ad48-b2d1953aaa9d 59676-960 HUMAN PRESCRIPTION DRUG DOXIL doxorubicin hydrochloride INJECTION, SUSPENSION, LIPOSOMAL INTRAVENOUS 19951117 NDA NDA050718 Janssen Products, LP DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 59679-001_936b1446-8c27-4689-8164-adcb0005f13a 59679-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130612 UNAPPROVED MEDICAL GAS Helping Hands Medical Supply OXYGEN 99 L/100L 59702-150_9192ed6e-3383-4147-a2bd-796562cd81eb 59702-150 HUMAN PRESCRIPTION DRUG Zonatuss benzonatate CAPSULE ORAL 20100226 ANDA ANDA040851 Atley Pharmaceuticals BENZONATATE 150 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 59702-661_d3c69436-a681-4e00-8db0-8cbfaac9627e 59702-661 HUMAN PRESCRIPTION DRUG ORBIVAN Butalbital, Acetaminophen, and Caffeine CAPSULE ORAL 20100423 ANDA ANDA040885 Atley Pharmaceuticals, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 300; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 59702-674_1ec465dd-6c22-45d4-8ef2-3825d64d3088 59702-674 HUMAN PRESCRIPTION DRUG Zolvit hydrocodone bitartrate and acetaminophen SOLUTION ORAL 20101101 ANDA ANDA040881 Atley Pharmaceuticals ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 10 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 59702-800_9d58e774-94a9-4007-880d-003ef41dfc56 59702-800 HUMAN PRESCRIPTION DRUG Atuss DS Tannate Suspension Tannate Suspension SUSPENSION ORAL 20061121 UNAPPROVED DRUG OTHER Atley Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 30; 30 mg/5mL; mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 59704-0001_823ad790-d12f-42c0-bf13-dc640c987b1b 59704-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS ALA Med dba Pulmonary Care Services OXYGEN 99 L/100L 59713-001_252e4485-ea4a-4942-a585-977984250be2 59713-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RECTAL 19920701 UNAPPROVED MEDICAL GAS Ann Arbor Welding Supply Co., Inc. DBA Arbor Specialty Gases OXYGEN 990 mL/L 59714-101_db07db3e-3bb8-4dc8-b608-8de5bd2a74c5 59714-101 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN LIQUID RESPIRATORY (INHALATION) 19691021 UNAPPROVED MEDICAL GAS AIRWAY OXYGEN INC OXYGEN 99 L/100L 59723-546_8f3f9c0b-8e22-4d58-98da-265e482f0f5c 59723-546 HUMAN OTC DRUG COMPLIANCE DISHWASHING LIQUID CHLOROXYLENOL SOAP TOPICAL 20130926 OTC MONOGRAPH NOT FINAL part333E ROYAL PAPER CORPORATION CHLOROXYLENOL 3 g/1000mL 59726-005_0c5c6711-a27e-458c-805b-2aa7c72cdbb9 59726-005 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20111201 OTC MONOGRAPH NOT FINAL part334 P & L Development of New York Corporation DOCUSATE SODIUM 100 mg/1 59726-016_9b417bb6-ebc3-4ed2-9d8d-9f2b38ffb881 59726-016 HUMAN OTC DRUG pain reliever extra strength Acetaminophen TABLET ORAL 20110815 OTC MONOGRAPH NOT FINAL part343 P and L Development of New York Corporation ACETAMINOPHEN 500 mg/1 59726-019_0d267c20-bea6-4e90-a168-301ce021d57e 59726-019 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130115 ANDA ANDA202727 P and L Development of New York Corporation LANSOPRAZOLE 15 mg/1 59726-020_4a9c606b-2d91-4465-8bfc-8b3d544c8999 59726-020 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130731 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 59726-021_3cda1309-7cf0-4e82-aec0-0fab25daebc6 59726-021 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 P and L Development of New York Corporation (ReadyInCase) ASPIRIN 81 mg/1 59726-022_e4bcce6c-9aaa-4789-a66d-952f9ab53cbf 59726-022 HUMAN OTC DRUG Ibuprofen IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20140731 ANDA ANDA078682 P and L Development of New York Corporation (ReadyInCase) IBUPROFEN 200 mg/1 59726-023_9d20e514-bb75-4943-80c4-9839ce46889b 59726-023 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140630 ANDA ANDA091353 P and L Development of New York Corporation (ReadyInCase) NAPROXEN SODIUM 220 mg/1 59726-024_38a7dec0-ccee-4ffb-904d-5c28b3f54786 59726-024 HUMAN OTC DRUG All Day Allergy Relief Cetirizine HCl TABLET ORAL 20140731 ANDA ANDA078780 P and L Development of New York Corporation (ReadyInCase) CETIRIZINE HYDROCHLORIDE 10 mg/1 59726-025_d8500c41-e539-458a-b7cb-6f670a13e90f 59726-025 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20140731 OTC MONOGRAPH FINAL part347 P and L Development of New York Corporation (ReadyInCase) DIMETHICONE 125 mg/1 59726-026_a9679d86-a116-41fc-962b-e02e6211747c 59726-026 HUMAN OTC DRUG Laxative Maximum Strength Sennosides TABLET ORAL 20140731 OTC MONOGRAPH NOT FINAL part334 P and L Development of New York Corporation (ReadyInCase) SENNOSIDES 25 mg/1 59726-027_74bbd4c1-ec8f-46db-861e-29ee45b30fca 59726-027 HUMAN OTC DRUG Mucus Relief DM Guaifenesin, Dextromethorphan HBr TABLET ORAL 20140731 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 59726-029_c0513830-26c5-401a-b9e7-a7c63636877c 59726-029 HUMAN OTC DRUG Cold and Flu Relief Nighttime Multi Symptom Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20140731 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 59726-100_b6026e9b-6337-42b7-888e-3fe1eb9b3536 59726-100 HUMAN OTC DRUG Daytime Sinus Relief Non Drowsy Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20131007 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 59726-101_933fd611-027d-4d74-9e40-5447979d3479 59726-101 HUMAN OTC DRUG Nighttime Sinus Relief Acetaminophen, Doxylamine succinate and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20121031 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 59726-107_bb60ce70-e8dd-40d3-9778-adec631d695b 59726-107 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20121207 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) GUAIFENESIN 400 mg/1 59726-109_546087f0-3f9a-42ff-885c-b488e75c9e46 59726-109 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan Hydrobromide and Guaifenesin TABLET ORAL 20100106 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 59726-117_1e9cd982-3088-46f3-bd5b-63e74818b838 59726-117 HUMAN OTC DRUG Pain Relief Ibuprofen TABLET, COATED ORAL 20120813 ANDA ANDA079174 P and L Development of New York Corporation IBUPROFEN 200 mg/1 59726-120_330de931-1b61-4b6a-875c-3db541af9151 59726-120 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120517 ANDA ANDA078682 PL Developments IBUPROFEN 200 mg/1 59726-127_8cd23c41-b25b-4a9f-85f1-d72be751f1a7 59726-127 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20130325 ANDA ANDA078653 P and L Development of New York Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 59726-129_95edc8b6-0162-40ad-a088-d7ebf00e1e7f 59726-129 HUMAN OTC DRUG All Day Allergy Relief Cetirizine HCl TABLET ORAL 20100901 ANDA ANDA078780 P and L Development of New York Corporation (ReadyInCase) CETIRIZINE HYDROCHLORIDE 10 mg/1 59726-159_b8dc4dd6-2b66-4b18-b2f7-732a74a92f8a 59726-159 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20140501 OTC MONOGRAPH NOT FINAL part343 P and L Development of New York Corporation (ReadyInCase) ACETAMINOPHEN 500 mg/1 59726-160_d6abd9ef-7589-4e86-a531-a7d7dce815df 59726-160 HUMAN OTC DRUG Senna S docusate sodium and sennosides TABLET ORAL 20120515 OTC MONOGRAPH NOT FINAL part334 P and L Development of New York Corporation DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 59726-161_08258477-5f2e-4343-8ab3-62a5f3181014 59726-161 HUMAN OTC DRUG Pain reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20110415 OTC MONOGRAPH FINAL part338 P and L Development of New York Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 59726-165_b2834fcc-cba7-41a7-9460-14755621b330 59726-165 HUMAN OTC DRUG Ibuprofen and Diphenhydramine HCl IBUPROFEN, DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED ORAL 20110901 ANDA ANDA090397 P and L Development of New York Corporation DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25; 200 mg/1; mg/1 59726-167_0720cdb6-3835-48a2-8530-c6f47a96142a 59726-167 HUMAN OTC DRUG Pain Relief Ibuprofen TABLET, COATED ORAL 20120928 ANDA ANDA072199 P and L Development of New York Corporation IBUPROFEN 200 mg/1 59726-169_45617c97-0ae0-417b-9ccc-8bd66cb1a89b 59726-169 HUMAN OTC DRUG All Day Pain Relief Naproxen sodium TABLET ORAL 20140228 ANDA ANDA079096 P and L Development of New York Corporation (ReadyInCase) NAPROXEN SODIUM 220 mg/1 59726-170_8632dcea-d09e-46be-8cf9-4dfc686f35d7 59726-170 HUMAN OTC DRUG Stool Softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20111201 OTC MONOGRAPH NOT FINAL part334 P & L Development of New York Corporation DOCUSATE CALCIUM 240 mg/1 59726-189_52c0fbc5-e3c4-4cd0-92f3-cbe333fe850f 59726-189 HUMAN OTC DRUG Allergy Relief Fexofenadine HCl TABLET ORAL 20130328 ANDA ANDA079112 P and L Development of New York Corporation FEXOFENADINE HYDROCHLORIDE 180 mg/1 59726-190_49157bb5-7cef-4d47-9308-e4c6c9b14325 59726-190 HUMAN OTC DRUG Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20100901 OTC MONOGRAPH NOT FINAL part334 P and L Development of New York Corporation BISACODYL 5 mg/1 59726-211_f40ae88b-a73d-412a-8392-259469f634fd 59726-211 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20130214 NDA NDA022429 P and L Development of New York Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 59726-213_da19280e-aaa4-421a-896c-d1284291268b 59726-213 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130115 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 59726-220_eb44a8b3-be84-4e0f-8e4a-14b928b347c8 59726-220 HUMAN OTC DRUG All Day Allergy Antihistamine Cetirizine HCl TABLET ORAL 20121205 ANDA ANDA078427 P and L Development of New York Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 59726-224_0c45c799-cac2-449a-ae5e-ce98cd887766 59726-224 HUMAN OTC DRUG EZ Nite Sleep Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH FINAL part338 P and L Development of New York Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59726-225_17d1e2cd-f0f0-40b8-b050-db6ebac0d389 59726-225 HUMAN OTC DRUG SnoozEase Nighttime Sleep-Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130411 OTC MONOGRAPH FINAL part338 P and L Development of New York Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59726-227_3f3b065f-e811-49dc-866b-727e9b6f3fea 59726-227 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET ORAL 20130301 OTC MONOGRAPH NOT FINAL part343 P and L Development of New York Corporation (ReadyInCase) ASPIRIN 81 mg/1 59726-230_a3076a91-b194-475a-952b-df58671d2149 59726-230 HUMAN OTC DRUG Nighttime Sleep Aid Maximum Strength DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20110902 OTC MONOGRAPH FINAL part338 P and L Development of New York Corporation DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 59726-236_4aa91bdf-4228-4670-8620-23bd76cc14f3 59726-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 59726-238_e3ef719f-1880-4aeb-8608-57e7ccd7f9c5 59726-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130730 OTC MONOGRAPH NOT FINAL part334 P and L Development of New York Corporation (ReadyInCase) DOCUSATE SODIUM 100 mg/1 59726-242_f47ab631-af88-4a5c-8ae3-c8c06fbdbb7e 59726-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH FINAL part347 P and L Development of New York Corporation (ReadyInCase) DIMETHICONE 125 mg/1 59726-247_0effb5e5-9134-4dc8-a81a-6bb92f7a22f8 59726-247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140501 OTC MONOGRAPH NOT FINAL part343 P and L Development of New York Corporation (ReadyInCase) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 59726-248_3a11305f-2ffe-4125-8757-51710973fe41 59726-248 HUMAN OTC DRUG Pain Relief Ibuprofen TABLET ORAL 20131130 ANDA ANDA079174 P and L Development of New York Corporation IBUPROFEN 200 mg/1 59726-249_6086a165-4ffb-4cec-bde4-5bf3e43fa0ba 59726-249 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20140228 ANDA ANDA079174 P and L Development of New York Corporation (ReadyInCase) IBUPROFEN 200 mg/1 59726-256_88d638de-1e8f-4f2f-a75a-740ca9dfcdd3 59726-256 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140328 ANDA ANDA091353 P and L Development of New York Corporation (ReadyInCase) NAPROXEN SODIUM 220 mg/1 59726-257_c337838a-0b7d-461a-8443-164565295d05 59726-257 HUMAN OTC DRUG Stool Softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 P and L Development of New York Corporation (ReadyInCase) DOCUSATE CALCIUM 240 mg/1 59726-258_a5a18375-6880-4aff-af61-1cc92bc8c978 59726-258 HUMAN OTC DRUG STOOL SOFTENER Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 P and L Development of New York Corporation (ReadyInCase) DOCUSATE SODIUM 250 mg/1 59726-360_eeec9bd3-d5db-4360-8dd5-4d872cb9ecf0 59726-360 HUMAN OTC DRUG Extra Strength Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20110902 OTC MONOGRAPH NOT FINAL part343 P and L Development of New York Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 59726-400_640bf72c-0836-4060-910b-65ec7d160bae 59726-400 HUMAN OTC DRUG Nighttime Sleep Easy DIPHENHYDRAMINE HCL TABLET ORAL 20121204 OTC MONOGRAPH FINAL part338 P and L Development of New York Corporation (ReadyInCase) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59726-440_e13a8fa8-f0b7-4e2c-903f-3291a361a05a 59726-440 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin TABLET, COATED ORAL 20100901 OTC MONOGRAPH FINAL part343 P and L Development of New York Corporation ASPIRIN 81 mg/1 59726-470_f020df9c-0eda-4d21-9221-461775e7a70b 59726-470 HUMAN OTC DRUG Multi- Symptom Relief DayTime ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED ORAL 20120201 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 59726-480_843d93e6-265d-4092-bbed-2896c35ae67e 59726-480 HUMAN OTC DRUG Multi-Symptom Nitetime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20111010 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 59726-520_04e150ab-3fbc-41d8-9b1a-192277724723 59726-520 HUMAN OTC DRUG Loperamide HCl Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20110830 NDA NDA021855 P and L Development of New York Corporation (ReadyInCase) LOPERAMIDE HYDROCHLORIDE 2 mg/1 59726-530_603b57a1-f10d-4aae-9a96-7f0f304adf6f 59726-530 HUMAN OTC DRUG Ultra Strength Gas Relief SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20110901 OTC MONOGRAPH FINAL part332 P and L Development of New York Corporation (ReadyInCase) DIMETHICONE 180 mg/1 59726-550_8b2fb6c1-3ee3-48a7-b855-7d8c2a8b4ba1 59726-550 HUMAN OTC DRUG Extra Strength Gas Relief SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20110901 OTC MONOGRAPH FINAL part332 P and L Development of New York Corporation DIMETHICONE 125 mg/1 59726-580_0707e67a-18c8-4e66-9b64-5ed69cc97734 59726-580 HUMAN OTC DRUG Ranitidine Ranitidine TABLET ORAL 20130319 ANDA ANDA078884 P and L Development of New York Corporation RANITIDINE HYDROCHLORIDE 75 mg/1 59726-670_5bd11daa-1584-45b3-9841-59444e43293d 59726-670 HUMAN OTC DRUG Nasal Decongestant Maximum Strength Phenylephrine HCl TABLET ORAL 20140228 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 59726-690_345a0270-468a-45ed-b56f-97cd6adb16a8 59726-690 HUMAN OTC DRUG Antihistimine Allergy DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20111208 OTC MONOGRAPH NOT FINAL part348 P and L Development of New York Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59726-691_d1929a92-63d5-4f36-aad5-a03c6475a407 59726-691 HUMAN OTC DRUG Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20130827 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59726-720_17fddc93-b2e9-44dd-b792-f9f7a340bf04 59726-720 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130207 OTC MONOGRAPH FINAL part336 P and L Development of New York Corporation (ReadyInCase) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59726-810_2b1de167-01cb-4083-a835-9e90cbac6f37 59726-810 HUMAN OTC DRUG Sinus and Allergy Releif PE Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20140228 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 59730-4202_b2145184-7093-495f-a36b-8bf1d56b6a09 59730-4202 HUMAN PRESCRIPTION DRUG NABI-HB HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN INJECTION INTRAMUSCULAR 20100310 BLA BLA991442 Biotest Pharmaceuticals Corporation HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 312 [iU]/mL Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] 59730-4203_41d93a91-4ad9-4906-b200-e2854074b516 59730-4203 HUMAN PRESCRIPTION DRUG NABI-HB HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN INJECTION INTRAMUSCULAR 20100312 BLA BLA991442 Biotest Pharmaceuticals Corporation HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 1560 [iU]/5mL Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] 59730-6502_d9436af6-5da9-4907-9006-3b0973af31ed 59730-6502 PLASMA DERIVATIVE BIVIGAM HUMAN IMMUNOGLOBULIN G INJECTION, SOLUTION INTRAVENOUS 20140327 BLA BLA125389 Biotest Pharmaceuticals Corporation HUMAN IMMUNOGLOBULIN G 5 g/50mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 59730-6503_d9436af6-5da9-4907-9006-3b0973af31ed 59730-6503 PLASMA DERIVATIVE BIVIGAM HUMAN IMMUNOGLOBULIN G INJECTION, SOLUTION INTRAVENOUS 20140327 BLA BLA125389 Biotest Pharmaceuticals Corporation HUMAN IMMUNOGLOBULIN G 10 g/100mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 59734-271_2b95fd20-e589-478e-b63c-4b06c18dde80 59734-271 HUMAN OTC DRUG Borba PMS Skin Rescue A.M. SPF 40 plus Treatment TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20110107 OTC MONOGRAPH NOT FINAL part352 Borba, Inc. TITANIUM DIOXIDE; ZINC OXIDE 25; 21 mg/mL; mg/mL 59734-274_92919178-f798-4f5c-825e-90624628980a 59734-274 HUMAN OTC DRUG Borba Age Defying Daily Hydrator SPF 30 Plus AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE LOTION TOPICAL 20110107 OTC MONOGRAPH NOT FINAL part352 Borba, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 50; 27.9; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 59734-275_b66d145c-04b5-40bd-a6e7-9fe35e5d0427 59734-275 HUMAN OTC DRUG Borba Age Defying Super Creme SPF 100 plus AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE LOTION TOPICAL 20110107 OTC MONOGRAPH NOT FINAL part352 Borba, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 50; 27.9; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 59734-276_16212c22-a706-4439-9f8f-387a147e9d7e 59734-276 HUMAN OTC DRUG Borba Age Defying Skin Lightening Spot Treatment HYDROQUINONE LOTION TOPICAL 20110107 OTC MONOGRAPH NOT FINAL part358A Borba, Inc. HYDROQUINONE 20 mg/mL 59735-100_74ebb324-403e-4cfe-8f15-e16e7512c936 59735-100 HUMAN OTC DRUG BO SPF15 Avobenzone, Octinoxate LOTION TOPICAL 20130927 OTC MONOGRAPH NOT FINAL part352 Mana Products AVOBENZONE; OCTINOXATE 3; 7.5 g/100g; g/100g 59735-130_63b32367-3208-4427-bad3-c9c17fe4f1ec 59735-130 HUMAN OTC DRUG Daily Moisturizer Broad-Spectrum SPF 30 Avobenzone, Octinoxate, Octisalate LOTION TOPICAL 20140127 OTC MONOGRAPH NOT FINAL part352 Mana Products AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100g; g/100g; g/100g 59735-300_a892e1d1-fc68-48db-9c42-debd4d555525 59735-300 HUMAN OTC DRUG Cover and Conceal Blemish Concealer Salicylic Acid CREAM TOPICAL 20040720 OTC MONOGRAPH FINAL part333 Biocosmetics research labs SALICYLIC ACID 1 g/100g 59735-302_1b8daa10-04f4-497b-8463-fcb81d685834 59735-302 HUMAN OTC DRUG Acne and Blemish Target Salicylic Acid GEL TOPICAL 20030213 OTC MONOGRAPH FINAL part333 Biocosmetics Research Labs SALICYLIC ACID 2 g/100g 59735-304_61be7ea1-7188-4fd6-9c3a-81b0eb76fff4 59735-304 HUMAN OTC DRUG Body Fade Creme Maximum Strength Hydroquinone CREAM TOPICAL 20091208 OTC MONOGRAPH FINAL part354 Biocosmetic Reasearch Labs HYDROQUINONE 2 g/100g 59735-306_57a46a6a-3434-4dbe-82d6-794c9ad50038 59735-306 HUMAN OTC DRUG Daily Fade SPF15 Sunscreen CREAM TOPICAL 20060306 OTC MONOGRAPH NOT FINAL part352 Biocosetic Research Labs AVOBENZONE; OCTINOXATE 2; 5 g/100g; g/100g 59735-308_e291cf51-0a51-4917-8b14-982ea3d5a322 59735-308 HUMAN OTC DRUG Daily Fade Maximum Strength SPF15 Hydroquinone SPF15 CREAM TOPICAL 20090603 OTC MONOGRAPH NOT FINAL part358 Biocosmetic Research Labs AVOBENZONE; HYDROQUINONE; OCTINOXATE 2; 2; 5 g/100g; g/100g; g/100g 59735-310_fed097e8-f13e-411b-b54c-5a7b0f433c84 59735-310 HUMAN OTC DRUG Advanced Dual Complex Fade Maximum Strength Plus Hydroquinone GEL TOPICAL 20090225 OTC MONOGRAPH NOT FINAL part358 Biocosmetic Research Labs HYDROQUINONE 2 g/100g 59735-312_1d33bb86-a544-4fdc-9f16-c76b848ab303 59735-312 HUMAN OTC DRUG Anti-acne Salicylic Acid LOTION TOPICAL 20080123 OTC MONOGRAPH FINAL part333 Biocosmetics Research Labs SALICYLIC ACID 2 g/100g 59735-314_7ebadcb8-7c7b-4409-8653-900b361ecc54 59735-314 HUMAN OTC DRUG Skin Perfecting Acne and Blemish Wash Salicylic Acid RINSE TOPICAL 20060619 OTC MONOGRAPH FINAL part333 Biocosmetics Research Labs SALICYLIC ACID .5 mL/100mL 59735-318_caf1f5b5-8bef-471c-9775-773a7e5ade71 59735-318 HUMAN OTC DRUG Essential Fade Complex Hydroquinone gel GEL TOPICAL 20110120 OTC MONOGRAPH NOT FINAL part358A Biocosmetics Research Lab HYDROQUINONE 2 g/100g 59741-101_7728b01a-9ee8-4322-9c6c-07058e252799 59741-101 HUMAN OTC DRUG Pain Relief Acetaminophen LIQUID ORAL 20140516 OTC MONOGRAPH NOT FINAL part343 Bio-Pharm, Inc. ACETAMINOPHEN 160 mg/5mL 59741-112_4f181b2f-d869-4831-af2b-8ded00d7f55d 59741-112 HUMAN OTC DRUG Tussin Guaifenesin SOLUTION ORAL 20140408 OTC MONOGRAPH FINAL part341 Bio-Pharm, Inc. GUAIFENESIN 100 mg/5mL 59741-116_bca62c37-a132-4af3-b4da-e2bad1535a6f 59741-116 HUMAN OTC DRUG Tussin DM Guaifenesin and Dextromethorphan Hydrobromide SOLUTION ORAL 20040101 OTC MONOGRAPH FINAL part341 Bio-Pharm, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 59741-119_487518cc-037f-4ba7-9fd0-00505d7b5eee 59741-119 HUMAN OTC DRUG Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 20140516 OTC MONOGRAPH FINAL part336 Bio-Pharm, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 59741-193_7859f14f-c019-4154-a55f-a4bffee3b872 59741-193 HUMAN OTC DRUG Assured Childrens Cold and Cough Brompheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride LIQUID ORAL 20111101 OTC MONOGRAPH FINAL part341 Bio-Pharm, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 59741-201_e16635a2-9911-4b4f-988a-e9a3d916d2d6 59741-201 HUMAN OTC DRUG Assured Day time Cold and Cough Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20111101 OTC MONOGRAPH FINAL part341 Bio-Pharm, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 59741-202_a17de757-a36d-4e40-aca8-ec21fde27583 59741-202 HUMAN OTC DRUG Assured Night time Cold and Cough Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride LIQUID ORAL 20111101 OTC MONOGRAPH FINAL part341 Bio-Pharm, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 59741-224_ae14c13c-13ce-4ad0-9d43-dfe774ebe808 59741-224 HUMAN OTC DRUG Chest Congestion Guaifenesin SOLUTION ORAL 20140516 OTC MONOGRAPH FINAL part341 Bio-Pharm, Inc. GUAIFENESIN 100 mg/5mL 59746-001_978d4f39-86b8-279f-2cff-753bf04c2a20 59746-001 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 JUBILANT CADISTA PHARMACEUTICALS, INC. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59746-002_978d4f39-86b8-279f-2cff-753bf04c2a20 59746-002 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 JUBILANT CADISTA PHARMACEUTICALS, INC. METHYLPREDNISOLONE 8 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59746-003_978d4f39-86b8-279f-2cff-753bf04c2a20 59746-003 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 JUBILANT CADISTA PHARMACEUTICALS, INC. METHYLPREDNISOLONE 16 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59746-010_126dc6ea-876f-b6e5-9bfc-9383cb8473cb 59746-010 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20101201 ANDA ANDA090839 Jubilant Cadista Pharmaceuticals Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 59746-012_605d97ef-867f-4ce3-a359-f789cdf22517 59746-012 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20050614 ANDA ANDA040514 JUBILANT CADISTA PHARMACEUTICALS, INC. FOLIC ACID 1 mg/1 59746-015_978d4f39-86b8-279f-2cff-753bf04c2a20 59746-015 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 JUBILANT CADISTA PHARMACEUTICALS, INC. METHYLPREDNISOLONE 32 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59746-020_126dc6ea-876f-b6e5-9bfc-9383cb8473cb 59746-020 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20101201 ANDA ANDA090839 Jubilant Cadista Pharmaceuticals Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 59746-030_126dc6ea-876f-b6e5-9bfc-9383cb8473cb 59746-030 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20101201 ANDA ANDA090839 Jubilant Cadista Pharmaceuticals Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 59746-040_126dc6ea-876f-b6e5-9bfc-9383cb8473cb 59746-040 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20101201 ANDA ANDA090839 Jubilant Cadista Pharmaceuticals Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 59746-050_126dc6ea-876f-b6e5-9bfc-9383cb8473cb 59746-050 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20101201 ANDA ANDA090839 Jubilant Cadista Pharmaceuticals Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 59746-113_167cf515-d528-fb66-3766-cf96ff536bf6 59746-113 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine Maleate TABLET ORAL 19980301 ANDA ANDA040268 JUBILANT CADISTA PHARMACEUTICALS, INC. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 59746-115_167cf515-d528-fb66-3766-cf96ff536bf6 59746-115 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine maleate TABLET ORAL 19980301 ANDA ANDA040268 JUBILANT CADISTA PHARMACEUTICALS, INC. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 59746-121_ce468d44-8d55-d851-7f93-cc6f392e8f0c 59746-121 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride TABLET ORAL 20100604 ANDA ANDA040659 JUBILANT CADISTA PHARMACEUTICALS, INC. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 59746-122_ce468d44-8d55-d851-7f93-cc6f392e8f0c 59746-122 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride TABLET ORAL 20100604 ANDA ANDA040659 JUBILANT CADISTA PHARMACEUTICALS, INC. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 59746-125_5c20e437-649c-3413-c991-205792d65c79 59746-125 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20071026 ANDA ANDA040809 JUBILANT CADISTA PHARMACEUTICALS, INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 59746-127_5c20e437-649c-3413-c991-205792d65c79 59746-127 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20071026 ANDA ANDA040809 JUBILANT CADISTA PHARMACEUTICALS, INC. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 59746-171_23df070f-e513-f1c3-2bad-d646350868ae 59746-171 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20050606 ANDA ANDA040611 JUBILANT CADISTA PHARMACEUTICALS, INC. PREDNISONE 1 mg/1 59746-172_c011927c-2c32-1f82-5175-2e05ac40686e 59746-172 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 JUBILANT CADISTA PHARMACEUTICALS, INC. PREDNISONE 5 mg/1 59746-173_c011927c-2c32-1f82-5175-2e05ac40686e 59746-173 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 JUBILANT CADISTA PHARMACEUTICALS, INC. PREDNISONE 10 mg/1 59746-175_c011927c-2c32-1f82-5175-2e05ac40686e 59746-175 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 JUBILANT CADISTA PHARMACEUTICALS, INC. PREDNISONE 20 mg/1 59746-177_2b5523bc-05e0-438f-54df-71de875ef394 59746-177 HUMAN PRESCRIPTION DRUG cyclobenzaprine hydrochloride cyclobenzaprine hydrochloride TABLET ORAL 20060406 ANDA ANDA077563 JUBILANT CADISTA PHARMACEUTICALS, INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 59746-211_2b5523bc-05e0-438f-54df-71de875ef394 59746-211 HUMAN PRESCRIPTION DRUG cyclobenzaprine hydrochloride cyclobenzaprine hydrochloride TABLET ORAL 20060404 ANDA ANDA077563 JUBILANT CADISTA PHARMACEUTICALS, INC. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 59746-216_33623629-0adf-2002-ef67-617e5100a28d 59746-216 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20130201 ANDA ANDA203253 Jubilant Cadista Pharmaceuticals Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 59746-217_33623629-0adf-2002-ef67-617e5100a28d 59746-217 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20130201 ANDA ANDA203253 Jubilant Cadista Pharmaceuticals Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 59746-218_33623629-0adf-2002-ef67-617e5100a28d 59746-218 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20130201 ANDA ANDA203253 Jubilant Cadista Pharmaceuticals Inc. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 59746-232_8d8703de-f908-a6a8-5c75-5b9082b4c575 59746-232 HUMAN PRESCRIPTION DRUG Oxcarbazepine oxcarbazepine TABLET, FILM COATED ORAL 20100214 ANDA ANDA090239 JUBILANT CADISTA PHARMACEUTICALS, INC. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59746-233_8d8703de-f908-a6a8-5c75-5b9082b4c575 59746-233 HUMAN PRESCRIPTION DRUG Oxcarbazepine oxcarbazepine TABLET, FILM COATED ORAL 20100214 ANDA ANDA090239 JUBILANT CADISTA PHARMACEUTICALS, INC. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59746-234_8d8703de-f908-a6a8-5c75-5b9082b4c575 59746-234 HUMAN PRESCRIPTION DRUG Oxcarbazepine oxcarbazepine TABLET, FILM COATED ORAL 20100214 ANDA ANDA090239 JUBILANT CADISTA PHARMACEUTICALS, INC. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59746-242_f6e0f518-8fa1-f32b-cb82-a5518ca6d35a 59746-242 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20110701 ANDA ANDA090557 Jubilant Cadista Pharmaceuticals Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 59746-244_f6e0f518-8fa1-f32b-cb82-a5518ca6d35a 59746-244 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20110701 ANDA ANDA090557 Jubilant Cadista Pharmaceuticals Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 59746-245_a7cca178-984b-0da2-1b67-62be0557a5d1 59746-245 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 JUBILANT CADISTA PHARMACEUTICALS, INC. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 59746-246_a7cca178-984b-0da2-1b67-62be0557a5d1 59746-246 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 JUBILANT CADISTA PHARMACEUTICALS, INC. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 59746-247_a7cca178-984b-0da2-1b67-62be0557a5d1 59746-247 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 JUBILANT CADISTA PHARMACEUTICALS, INC. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 59746-248_a7cca178-984b-0da2-1b67-62be0557a5d1 59746-248 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 JUBILANT CADISTA PHARMACEUTICALS, INC. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 59746-267_017a32c7-ecb9-0fcb-52e7-6642e1a4d0bf 59746-267 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20130801 ANDA ANDA090762 JUBILANT CADISTA PHARMACEUTICALS, INC. MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 59746-268_017a32c7-ecb9-0fcb-52e7-6642e1a4d0bf 59746-268 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET, FILM COATED ORAL 20130801 ANDA ANDA090762 JUBILANT CADISTA PHARMACEUTICALS, INC. MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 59746-279_9fe2a13c-2aa1-b7c7-ad0d-b6c4fef45a91 59746-279 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120914 ANDA ANDA202280 Jubilant Cadista Pharmaceuticals Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59746-280_9fe2a13c-2aa1-b7c7-ad0d-b6c4fef45a91 59746-280 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120914 ANDA ANDA202280 Jubilant Cadista Pharmaceuticals Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59746-281_9fe2a13c-2aa1-b7c7-ad0d-b6c4fef45a91 59746-281 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120914 ANDA ANDA202280 Jubilant Cadista Pharmaceuticals Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59746-283_9770b098-f65e-1878-638f-b9ef8be9e783 59746-283 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110901 ANDA ANDA090901 Jubilant Cadista Pharmaceuticals Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 59746-284_9770b098-f65e-1878-638f-b9ef8be9e783 59746-284 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110901 ANDA ANDA090901 Jubilant Cadista Pharmaceuticals Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 59746-306_ca3645d4-9b0d-e1b7-61c6-d56a3944bee5 59746-306 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120913 ANDA ANDA200221 Jubilant Cadista Pharmaceuticals Inc OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 59746-307_ca3645d4-9b0d-e1b7-61c6-d56a3944bee5 59746-307 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120913 ANDA ANDA200221 Jubilant Cadista Pharmaceuticals Inc OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 59746-308_ca3645d4-9b0d-e1b7-61c6-d56a3944bee5 59746-308 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120913 ANDA ANDA200221 Jubilant Cadista Pharmaceuticals Inc OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 59746-309_ca3645d4-9b0d-e1b7-61c6-d56a3944bee5 59746-309 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120913 ANDA ANDA200221 Jubilant Cadista Pharmaceuticals Inc OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 59746-311_900d5b27-2eb8-f9d6-7476-8b88198ba275 59746-311 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20110320 ANDA ANDA200220 Jubilant Cadista Pharmaceuticals Inc. LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 59746-312_900d5b27-2eb8-f9d6-7476-8b88198ba275 59746-312 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20110320 ANDA ANDA200220 Jubilant Cadista Pharmaceuticals Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 59746-313_bfa5ed7a-1b5d-5545-f483-6edb1fe5d8f5 59746-313 HUMAN PRESCRIPTION DRUG bupropion hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120601 ANDA ANDA202775 Jubilant Cadista Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 59746-315_b68f4673-4722-9e7a-e164-47e67f06ca9a 59746-315 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131011 ANDA ANDA202774 Jubilant Cadista Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 59746-316_b68f4673-4722-9e7a-e164-47e67f06ca9a 59746-316 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131011 ANDA ANDA202774 Jubilant Cadista Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 59746-317_b68f4673-4722-9e7a-e164-47e67f06ca9a 59746-317 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131011 ANDA ANDA202774 Jubilant Cadista Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 59746-324_ea003018-25b8-d862-f25e-a7ef7831441d 59746-324 HUMAN PRESCRIPTION DRUG valacyclovir hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20120405 ANDA ANDA201506 Jubilant Cadista Pharmaceuticals Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 59746-325_ea003018-25b8-d862-f25e-a7ef7831441d 59746-325 HUMAN PRESCRIPTION DRUG valacyclovir hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20120405 ANDA ANDA201506 Jubilant Cadista Pharmaceuticals Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 59746-329_accfb8c7-9089-33d9-3bb5-8b2a0a0e1afb 59746-329 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110529 ANDA ANDA090768 Jubilant Cadista Pharmaceuticals Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 59746-330_accfb8c7-9089-33d9-3bb5-8b2a0a0e1afb 59746-330 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110529 ANDA ANDA090768 Jubilant Cadista Pharmaceuticals Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 59746-333_e9bd4031-4d72-c3e3-84b6-28759abd87bd 59746-333 HUMAN PRESCRIPTION DRUG Losartan potassium Tablets, 25 mg losartan potassium TABLET ORAL 20120918 ANDA ANDA201170 Jubilant Cadista Pharmaceuticals Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 59746-334_e9bd4031-4d72-c3e3-84b6-28759abd87bd 59746-334 HUMAN PRESCRIPTION DRUG Losartan potassium Tablets, 50 mg losartan potassium TABLET ORAL 20120918 ANDA ANDA201170 Jubilant Cadista Pharmaceuticals Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 59746-335_e9bd4031-4d72-c3e3-84b6-28759abd87bd 59746-335 HUMAN PRESCRIPTION DRUG Losartan potassium Tablets, 100 mg losartan potassium TABLET ORAL 20120918 ANDA ANDA201170 Jubilant Cadista Pharmaceuticals Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 59746-337_b887fd25-5d60-c61a-c570-3cb5ee624faf 59746-337 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 20121030 ANDA ANDA201845 JUBILANT CADISTA PHARMACEUTICALS, INC. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 59746-338_b887fd25-5d60-c61a-c570-3cb5ee624faf 59746-338 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 20121030 ANDA ANDA201845 JUBILANT CADISTA PHARMACEUTICALS, INC. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 59746-339_b887fd25-5d60-c61a-c570-3cb5ee624faf 59746-339 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 20121030 ANDA ANDA201845 JUBILANT CADISTA PHARMACEUTICALS, INC. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 59746-348_15e418ff-3d05-a2b2-8912-38dc5b454b81 59746-348 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20131127 ANDA ANDA203150 Jubilant Cadista Pharmaceuticals Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 59746-382_d609f268-32f9-db97-2cc0-0143866b6ec9 59746-382 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20080211 ANDA ANDA078391 JUBILANT CADISTA PHARMACEUTICALS, INC. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 59746-383_f10e69a6-bd65-ca89-5a18-8b70c7977b83 59746-383 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Jubilant Cadista Pharmaceuticals Inc. TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 59746-384_f10e69a6-bd65-ca89-5a18-8b70c7977b83 59746-384 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Jubilant Cadista Pharmaceuticals Inc. TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 59746-385_f10e69a6-bd65-ca89-5a18-8b70c7977b83 59746-385 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Jubilant Cadista Pharmaceuticals Inc. TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 59746-386_f10e69a6-bd65-ca89-5a18-8b70c7977b83 59746-386 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041221 ANDA ANDA075317 Jubilant Cadista Pharmaceuticals Inc. TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 59746-432_2687a801-fb6c-c055-1900-99ce5d0497bd 59746-432 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20141120 ANDA ANDA202279 Jubilant Cadista Pharmaceuticals Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 59746-433_2687a801-fb6c-c055-1900-99ce5d0497bd 59746-433 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20141120 ANDA ANDA202279 Jubilant Cadista Pharmaceuticals Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 59752-0124_ea800b91-abb2-471f-b5b3-55b8f74a587f 59752-0124 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20050510 UNAPPROVED MEDICAL GAS Buffalo Wheelchair dba Naples Oxygen OXYGEN 99 L/100L 59754-002_3c2687c5-ce06-4322-8977-eccd3fea3ff4 59754-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20100801 UNAPPROVED MEDICAL GAS Specialty Gases of America LLC NITROGEN 99 L/100L 59756-511_a5db0cca-9cd0-40ac-88f4-3b829e41782e 59756-511 HUMAN OTC DRUG GREAT II LOTIONIZED ANTISEPTIC CHLOROXYLENOL SOAP TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333E MEYER LABORATORY CHLOROXYLENOL 3 g/1000mL 59759-557_9019cfc2-7ca3-41c3-9020-9a5c4a235630 59759-557 HUMAN OTC DRUG SOFT SADDLE CHLOROXYLENOL SOAP TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E BAUMANN PAPER COMPANY CHLOROXYLENOL 2.5 g/1000mL 59760-001_a285c209-f423-43b7-ae11-8854502f2c7e 59760-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20101130 UNAPPROVED MEDICAL GAS Aeroflow, Inc dba Aeroflow Healthcare OXYGEN 99 L/100L 59762-0016_f2f17d47-ca59-4934-91bd-e1eb70f3a62a 59762-0016 HUMAN PRESCRIPTION DRUG clindamycin palmitate hydrochloride clindamycin palmitate hydrochloride SOLUTION ORAL 19710916 ANDA ANDA062644 Greenstone LLC CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 59762-0028_bd522799-f92d-48eb-8f14-a03dcffb8978 59762-0028 HUMAN PRESCRIPTION DRUG Diclofenac sodium and Misoprostol Diclofenac sodium and Misoprostol TABLET, FILM COATED ORAL 20121101 NDA AUTHORIZED GENERIC NDA020607 Greenstone LLC DICLOFENAC SODIUM; MISOPROSTOL 50; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 59762-0029_bd522799-f92d-48eb-8f14-a03dcffb8978 59762-0029 HUMAN PRESCRIPTION DRUG Diclofenac sodium and Misoprostol Diclofenac sodium and Misoprostol TABLET, FILM COATED ORAL 20121101 NDA AUTHORIZED GENERIC NDA020607 Greenstone LLC DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 59762-0033_4adc9f4b-f008-4f64-afc3-7c4c54369be2 59762-0033 HUMAN PRESCRIPTION DRUG Sildenafil sildenafil citrate TABLET, FILM COATED ORAL 20120927 NDA AUTHORIZED GENERIC NDA021845 Greenstone LLC SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 59762-0040_6e58da83-9b6b-4efc-a947-822f64fa27d3 59762-0040 HUMAN PRESCRIPTION DRUG Trifluridine TRIFLURIDINE SOLUTION OPHTHALMIC 19800410 NDA AUTHORIZED GENERIC NDA018299 Greenstone LLC TRIFLURIDINE 1 g/100mL Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 59762-0047_f5e963e0-560a-470d-b6ff-bf19c8faf82a 59762-0047 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Extended Release tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20000222 NDA NDA021228 Greenstone LLC TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 59762-0048_f5e963e0-560a-470d-b6ff-bf19c8faf82a 59762-0048 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Extended Release tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20000222 NDA NDA021228 Greenstone LLC TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 59762-0049_ba5e4b00-8948-4481-bf8d-f9e2461038e7 59762-0049 HUMAN PRESCRIPTION DRUG Methylprednisolone methylprednisolone TABLET ORAL 20130325 NDA AUTHORIZED GENERIC NDA011153 Greenstone LLC METHYLPREDNISOLONE 8 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59762-0050_ba5e4b00-8948-4481-bf8d-f9e2461038e7 59762-0050 HUMAN PRESCRIPTION DRUG Methylprednisolone methylprednisolone TABLET ORAL 20130325 NDA AUTHORIZED GENERIC NDA011153 Greenstone LLC METHYLPREDNISOLONE 16 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59762-0051_ba5e4b00-8948-4481-bf8d-f9e2461038e7 59762-0051 HUMAN PRESCRIPTION DRUG Methylprednisolone methylprednisolone TABLET ORAL 20130325 NDA AUTHORIZED GENERIC NDA011153 Greenstone LLC METHYLPREDNISOLONE 32 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59762-0057_c19643ef-9a51-4d1c-8bb6-d33169cc97ba 59762-0057 HUMAN PRESCRIPTION DRUG Alprazolam XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA AUTHORIZED GENERIC NDA021434 Greenstone LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 59762-0059_c19643ef-9a51-4d1c-8bb6-d33169cc97ba 59762-0059 HUMAN PRESCRIPTION DRUG Alprazolam XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA AUTHORIZED GENERIC NDA021434 Greenstone LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 59762-0066_c19643ef-9a51-4d1c-8bb6-d33169cc97ba 59762-0066 HUMAN PRESCRIPTION DRUG Alprazolam XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA AUTHORIZED GENERIC NDA021434 Greenstone LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 59762-0068_c19643ef-9a51-4d1c-8bb6-d33169cc97ba 59762-0068 HUMAN PRESCRIPTION DRUG Alprazolam XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA AUTHORIZED GENERIC NDA021434 Greenstone LLC ALPRAZOLAM 3 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 59762-0073_697f1058-8f53-4db6-a029-35e8f0f2816d 59762-0073 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20130220 NDA AUTHORIZED GENERIC NDA008697 Greenstone LLC HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59762-0074_697f1058-8f53-4db6-a029-35e8f0f2816d 59762-0074 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20130220 NDA AUTHORIZED GENERIC NDA008697 Greenstone LLC HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59762-0075_697f1058-8f53-4db6-a029-35e8f0f2816d 59762-0075 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20130220 NDA AUTHORIZED GENERIC NDA008697 Greenstone LLC HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59762-0104_8a5a887a-264f-4d89-9a1d-f27b22c8171f 59762-0104 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET, DELAYED RELEASE ORAL 20050505 NDA AUTHORIZED GENERIC NDA007073 Greenstone LLC SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 59762-0119_ce9f36a4-ab8a-4ff3-87fb-496268212dc8 59762-0119 HUMAN PRESCRIPTION DRUG phenelzine sulfate Phenelzine Sulfate TABLET, FILM COATED ORAL 19610609 NDA NDA011909 Greenstone LLC PHENELZINE SULFATE 15 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] 59762-0140_b168eeb1-afae-4fc1-8530-e100819c6838 59762-0140 HUMAN PRESCRIPTION DRUG Piroxicam piroxicam CAPSULE ORAL 20140303 NDA NDA018147 Greenstone LLC PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 59762-0145_b168eeb1-afae-4fc1-8530-e100819c6838 59762-0145 HUMAN PRESCRIPTION DRUG Piroxicam piroxicam CAPSULE ORAL 20140303 NDA NDA018147 Greenstone LLC PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 59762-0155_eeb4c214-83fb-4ce1-a12e-ad81c434b5d3 59762-0155 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130101 NDA AUTHORIZED GENERIC NDA020702 Greenstone LLC ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59762-0156_eeb4c214-83fb-4ce1-a12e-ad81c434b5d3 59762-0156 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Greenstone LLC ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59762-0157_eeb4c214-83fb-4ce1-a12e-ad81c434b5d3 59762-0157 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Greenstone LLC ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59762-0158_eeb4c214-83fb-4ce1-a12e-ad81c434b5d3 59762-0158 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Greenstone LLC ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59762-0170_08a5b4ef-2134-4e06-9837-1318f84868ef 59762-0170 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate TABLET, FILM COATED ORAL 20140121 NDA AUTHORIZED GENERIC NDA020771 Greenstone LLC TOLTERODINE TARTRATE 1 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 59762-0180_ad27c05f-bd7f-42bd-ba3a-c62eb169c7c9 59762-0180 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110602 NDA AUTHORIZED GENERIC NDA020699 Greenstone LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59762-0181_ad27c05f-bd7f-42bd-ba3a-c62eb169c7c9 59762-0181 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110602 NDA AUTHORIZED GENERIC NDA020699 Greenstone LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59762-0182_ad27c05f-bd7f-42bd-ba3a-c62eb169c7c9 59762-0182 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110602 NDA AUTHORIZED GENERIC NDA020699 Greenstone LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59762-0220_0ac824d6-ee37-42f9-a7f6-1f89b147b924 59762-0220 HUMAN PRESCRIPTION DRUG quinapril hydrochloride and hydrochlorothiazide quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 19991228 NDA AUTHORIZED GENERIC NDA020125 Greenstone LLC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 59762-0222_0ac824d6-ee37-42f9-a7f6-1f89b147b924 59762-0222 HUMAN PRESCRIPTION DRUG quinapril hydrochloride and hydrochlorothiazide quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 19991228 NDA AUTHORIZED GENERIC NDA020125 Greenstone LLC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 59762-0223_0ac824d6-ee37-42f9-a7f6-1f89b147b924 59762-0223 HUMAN PRESCRIPTION DRUG quinapril hydrochloride and hydrochlorothiazide quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 19991228 NDA AUTHORIZED GENERIC NDA020125 Greenstone LLC HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 59762-0245_f9bcac55-5b0a-4213-89bd-7d6d30ca76e2 59762-0245 HUMAN PRESCRIPTION DRUG donepezil hydrochloride DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 19961126 NDA NDA020690 Greenstone LLC DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 59762-0246_f9bcac55-5b0a-4213-89bd-7d6d30ca76e2 59762-0246 HUMAN PRESCRIPTION DRUG donepezil hydrochloride DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 19961126 NDA NDA020690 Greenstone LLC DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 59762-0250_f9bcac55-5b0a-4213-89bd-7d6d30ca76e2 59762-0250 HUMAN PRESCRIPTION DRUG donepezil hydrochloride ODT DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING ORAL 20041018 NDA NDA021720 Greenstone LLC DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 59762-0252_f9bcac55-5b0a-4213-89bd-7d6d30ca76e2 59762-0252 HUMAN PRESCRIPTION DRUG donepezil hydrochloride ODT DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING ORAL 20041018 NDA NDA021720 Greenstone LLC DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 59762-0278_f9c3844e-948c-4c7a-8edf-6433fe1c81a2 59762-0278 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 20150228 ANDA ANDA201043 Greenstone LLC LEVOFLOXACIN 250 mg/1 59762-0279_f9c3844e-948c-4c7a-8edf-6433fe1c81a2 59762-0279 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 20150430 ANDA ANDA201043 Greenstone LLC LEVOFLOXACIN 500 mg/1 59762-0280_f9c3844e-948c-4c7a-8edf-6433fe1c81a2 59762-0280 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 20150131 ANDA ANDA201043 Greenstone LLC LEVOFLOXACIN 750 mg/1 59762-0333_37793ac6-7e6e-4331-a05c-367cd1eaf27b 59762-0333 HUMAN PRESCRIPTION DRUG Latanoprost Latanoprost SOLUTION OPHTHALMIC 19950320 NDA AUTHORIZED GENERIC NDA020597 Greenstone LLC LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 59762-0333_e910ed7f-b439-49e9-ba09-faff7aa720b7 59762-0333 HUMAN PRESCRIPTION DRUG Latanoprost Latanoprost SOLUTION OPHTHALMIC 19950320 NDA AUTHORIZED GENERIC NDA020597 Greenstone LLC LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 59762-0450_64d2c90a-a1c4-42b4-9ef4-599fb81f8b18 59762-0450 HUMAN PRESCRIPTION DRUG Colestipol Hydrochloride Colestipol Hydrochloride TABLET ORAL 19940719 NDA AUTHORIZED GENERIC NDA020222 Greenstone LLC COLESTIPOL HYDROCHLORIDE 1 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 59762-0489_70a56cb1-d40d-4134-87b6-767459d263ac 59762-0489 HUMAN PRESCRIPTION DRUG NITROGLYCERIN nitroglycerin TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20030408 NDA AUTHORIZED GENERIC NDA021134 Greenstone LLC NITROGLYCERIN .6 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 59762-0531_3985e032-15f9-441f-9d33-9255716290f1 59762-0531 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20121009 NDA AUTHORIZED GENERIC NDA008762 Greenstone LLC PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59762-0540_164199cd-fc2b-4590-ae53-9b5ed03c9751 59762-0540 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 20130529 NDA AUTHORIZED GENERIC NDA020329 Greenstone LLC GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 59762-0541_164199cd-fc2b-4590-ae53-9b5ed03c9751 59762-0541 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 20130529 NDA AUTHORIZED GENERIC NDA020329 Greenstone LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 59762-0542_164199cd-fc2b-4590-ae53-9b5ed03c9751 59762-0542 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 20130529 NDA AUTHORIZED GENERIC NDA020329 Greenstone LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 59762-0702_9efe0b54-8df2-432c-9451-b00127d63ffe 59762-0702 HUMAN PRESCRIPTION DRUG mycophenolate mofetil mycophenolate mofetil TABLET, FILM COATED ORAL 20100611 ANDA ANDA090456 Greenstone LLC MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 59762-0703_9efe0b54-8df2-432c-9451-b00127d63ffe 59762-0703 HUMAN PRESCRIPTION DRUG mycophenolate mofetil mycophenolate mofetil CAPSULE ORAL 20100611 ANDA ANDA090055 Greenstone LLC MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 59762-0800_08a5b4ef-2134-4e06-9837-1318f84868ef 59762-0800 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate TABLET, FILM COATED ORAL 20140121 NDA AUTHORIZED GENERIC NDA020771 Greenstone LLC TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 59762-0810_6d3c2134-e71a-404b-b2c1-9effff159e63 59762-0810 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 20140428 NDA AUTHORIZED GENERIC NDA018063 Greenstone LLC NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 59762-0811_6d3c2134-e71a-404b-b2c1-9effff159e63 59762-0811 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 20140428 NDA AUTHORIZED GENERIC NDA018063 Greenstone LLC NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 59762-0812_6d3c2134-e71a-404b-b2c1-9effff159e63 59762-0812 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 20140428 NDA AUTHORIZED GENERIC NDA018063 Greenstone LLC NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 59762-0850_f749e03c-c107-461c-8cf2-22a1db23b397 59762-0850 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20071030 20160229 ANDA ANDA078341 Greenstone LLC FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 59762-0925_ac0a2172-37c6-4661-8f5d-1b1ec9f3e947 59762-0925 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20020501 NDA NDA021266 Greenstone LLC VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 59762-0930_ac0a2172-37c6-4661-8f5d-1b1ec9f3e947 59762-0930 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20020501 NDA NDA021266 Greenstone LLC VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 59762-0935_ac0a2172-37c6-4661-8f5d-1b1ec9f3e947 59762-0935 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole POWDER, FOR SUSPENSION ORAL 20131216 NDA NDA021630 Greenstone LLC VORICONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 59762-1001_5bc14980-33b0-4840-a231-b31e1e63258f 59762-1001 HUMAN PRESCRIPTION DRUG Sirolimus SIROLIMUS TABLET, SUGAR COATED ORAL 20140107 NDA AUTHORIZED GENERIC NDA021110 Greenstone LLC SIROLIMUS .5 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA] 59762-1002_5bc14980-33b0-4840-a231-b31e1e63258f 59762-1002 HUMAN PRESCRIPTION DRUG Sirolimus SIROLIMUS TABLET, SUGAR COATED ORAL 20141027 NDA AUTHORIZED GENERIC NDA021110 Greenstone LLC SIROLIMUS 1 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA] 59762-1003_5bc14980-33b0-4840-a231-b31e1e63258f 59762-1003 HUMAN PRESCRIPTION DRUG Sirolimus SIROLIMUS TABLET, SUGAR COATED ORAL 20141027 NDA AUTHORIZED GENERIC NDA021110 Greenstone LLC SIROLIMUS 2 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA] 59762-1004_6c56334f-e186-4dba-aed2-4a638c924fc3 59762-1004 HUMAN PRESCRIPTION DRUG nifedipine nifedipine CAPSULE ORAL 20130325 NDA AUTHORIZED GENERIC NDA018482 Greenstone LLC NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 59762-1005_dafc3382-2af3-4f9b-b555-f368fe08cfff 59762-1005 HUMAN PRESCRIPTION DRUG Cabergoline cabergoline TABLET ORAL 20140922 NDA AUTHORIZED GENERIC NDA020664 Greenstone LLC CABERGOLINE .5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 59762-1020_b25337f8-0098-460e-ae20-57d74b0dc989 59762-1020 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 20150331 ANDA ANDA065271 Greenstone LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 59762-1021_b25337f8-0098-460e-ae20-57d74b0dc989 59762-1021 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 20150430 ANDA ANDA065271 Greenstone LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 59762-1050_3a5966a9-50a2-43a8-ab30-9e8125ca521a 59762-1050 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 20150531 ANDA ANDA065256 Greenstone LLC AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 59762-1061_4722b2fc-2dba-41fc-a447-fede5fdc8807 59762-1061 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate DIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATE TABLET ORAL 20130227 NDA AUTHORIZED GENERIC NDA012462 Greenstone LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 59762-1261_bdedb981-e259-460e-88f9-6c5a048554ee 59762-1261 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol Fumarate TABLET, FILM COATED ORAL 20061227 20150331 ANDA ANDA077910 Greenstone LLC BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 59762-1300_275100bd-9dee-4e67-9717-251ba9163bac 59762-1300 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 20150228 ANDA ANDA077739 Greenstone LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 59762-1301_275100bd-9dee-4e67-9717-251ba9163bac 59762-1301 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 20160331 ANDA ANDA077739 Greenstone LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 59762-1302_275100bd-9dee-4e67-9717-251ba9163bac 59762-1302 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 20151031 ANDA ANDA077739 Greenstone LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 59762-1350_96c6bb92-b209-460f-ad72-09b3fe47b5d9 59762-1350 HUMAN PRESCRIPTION DRUG Rifabutin rifabutin CAPSULE ORAL 20140407 NDA NDA050689 Greenstone LLC RIFABUTIN 150 mg/1 Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient] 59762-1415_b457660b-e0f0-44c0-beed-d5ab1f8e2782 59762-1415 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 20150531 ANDA ANDA076921 Greenstone LLC MIRTAZAPINE 7.5 mg/1 59762-1416_b457660b-e0f0-44c0-beed-d5ab1f8e2782 59762-1416 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 20150228 ANDA ANDA076921 Greenstone LLC MIRTAZAPINE 15 mg/1 59762-1417_b457660b-e0f0-44c0-beed-d5ab1f8e2782 59762-1417 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 20150131 ANDA ANDA076921 Greenstone LLC MIRTAZAPINE 30 mg/1 59762-1418_b457660b-e0f0-44c0-beed-d5ab1f8e2782 59762-1418 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 20150131 ANDA ANDA076921 Greenstone LLC MIRTAZAPINE 45 mg/1 59762-1515_e99fce06-0219-44bd-b359-8c9c0fcc375a 59762-1515 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Greenstone LLC CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 59762-1516_e99fce06-0219-44bd-b359-8c9c0fcc375a 59762-1516 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Greenstone LLC CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 59762-1517_e99fce06-0219-44bd-b359-8c9c0fcc375a 59762-1517 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Greenstone LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 59762-1518_e99fce06-0219-44bd-b359-8c9c0fcc375a 59762-1518 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Greenstone LLC CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 59762-1520_8c56f361-32ca-436c-af5e-fabb7be1c450 59762-1520 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20070323 NDA AUTHORIZED GENERIC NDA019787 Greenstone LLC AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 59762-1530_8c56f361-32ca-436c-af5e-fabb7be1c450 59762-1530 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20070323 NDA AUTHORIZED GENERIC NDA019787 Greenstone LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 59762-1537_6e7eedd0-e783-4c87-b4ff-9164954ef0eb 59762-1537 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 20150131 ANDA ANDA065435 Greenstone LLC PENICILLIN V POTASSIUM 500 mg/1 59762-1540_8c56f361-32ca-436c-af5e-fabb7be1c450 59762-1540 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20070323 NDA AUTHORIZED GENERIC NDA019787 Greenstone LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 59762-1700_fd3a4994-67ea-4a85-a75f-6e450c166fd4 59762-1700 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 20150531 ANDA ANDA078249 Greenstone LLC TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 59762-1701_fd3a4994-67ea-4a85-a75f-6e450c166fd4 59762-1701 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 20150531 ANDA ANDA078249 Greenstone LLC TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 59762-1702_fd3a4994-67ea-4a85-a75f-6e450c166fd4 59762-1702 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 20150630 ANDA ANDA078249 Greenstone LLC TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 59762-1703_fd3a4994-67ea-4a85-a75f-6e450c166fd4 59762-1703 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 20150531 ANDA ANDA078249 Greenstone LLC TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 59762-1710_062490ba-e4e5-4530-bcbc-8d4ae3576c6b 59762-1710 HUMAN PRESCRIPTION DRUG Eplerenone EPLERENONE TABLET, FILM COATED ORAL 20020927 NDA AUTHORIZED GENERIC NDA021437 Greenstone LLC EPLERENONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 59762-1720_062490ba-e4e5-4530-bcbc-8d4ae3576c6b 59762-1720 HUMAN PRESCRIPTION DRUG Eplerenone EPLERENONE TABLET, FILM COATED ORAL 20020927 NDA AUTHORIZED GENERIC NDA021437 Greenstone LLC EPLERENONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 59762-1735_d59c1964-c450-4a89-9a4a-4049e0baf73f 59762-1735 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20070919 20151231 ANDA ANDA078164 Greenstone LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 59762-1808_e453679f-3aed-4d42-b293-77a5b5727f9e 59762-1808 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 20160831 ANDA ANDA078406 Greenstone LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59762-1810_e453679f-3aed-4d42-b293-77a5b5727f9e 59762-1810 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 20161031 ANDA ANDA078406 Greenstone LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59762-1812_e453679f-3aed-4d42-b293-77a5b5727f9e 59762-1812 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 20160831 ANDA ANDA078406 Greenstone LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59762-1815_e453679f-3aed-4d42-b293-77a5b5727f9e 59762-1815 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 20160630 ANDA ANDA078406 Greenstone LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59762-1851_0a0643a4-9e36-4afe-9bc8-72143a08bb6c 59762-1851 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 20151130 ANDA ANDA078327 Greenstone LLC SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 59762-1852_0a0643a4-9e36-4afe-9bc8-72143a08bb6c 59762-1852 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 20151231 ANDA ANDA078327 Greenstone LLC SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 59762-2001_57153f8c-0016-4318-8f67-3d142acd398a 59762-2001 HUMAN PRESCRIPTION DRUG Ziprasidone ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA AUTHORIZED GENERIC NDA020825 Greenstone LLC ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 59762-2002_57153f8c-0016-4318-8f67-3d142acd398a 59762-2002 HUMAN PRESCRIPTION DRUG Ziprasidone ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA AUTHORIZED GENERIC NDA020825 Greenstone LLC ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 59762-2003_57153f8c-0016-4318-8f67-3d142acd398a 59762-2003 HUMAN PRESCRIPTION DRUG Ziprasidone ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA AUTHORIZED GENERIC NDA020825 Greenstone LLC ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 59762-2004_57153f8c-0016-4318-8f67-3d142acd398a 59762-2004 HUMAN PRESCRIPTION DRUG Ziprasidone ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA AUTHORIZED GENERIC NDA020825 Greenstone LLC ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 59762-2310_5a6857f2-96ef-4770-adbb-79aa471ab2a2 59762-2310 HUMAN PRESCRIPTION DRUG Doxazosin mesylate doxazosin mesylate TABLET ORAL 20140707 NDA NDA019668 Greenstone LLC DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 59762-2320_5a6857f2-96ef-4770-adbb-79aa471ab2a2 59762-2320 HUMAN PRESCRIPTION DRUG Doxazosin mesylate doxazosin mesylate TABLET ORAL 20140707 NDA NDA019668 Greenstone LLC DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 59762-2331_b22c6881-8fa5-4dba-b100-abcbeba35d39 59762-2331 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 20151130 ANDA ANDA077870 Greenstone LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 59762-2332_b22c6881-8fa5-4dba-b100-abcbeba35d39 59762-2332 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 20160229 ANDA ANDA077870 Greenstone LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 59762-2340_5a6857f2-96ef-4770-adbb-79aa471ab2a2 59762-2340 HUMAN PRESCRIPTION DRUG Doxazosin mesylate doxazosin mesylate TABLET ORAL 20140707 NDA NDA019668 Greenstone LLC DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 59762-2380_5a6857f2-96ef-4770-adbb-79aa471ab2a2 59762-2380 HUMAN PRESCRIPTION DRUG Doxazosin mesylate doxazosin mesylate TABLET ORAL 20140707 NDA NDA019668 Greenstone LLC DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 59762-2701_36076206-b35f-450f-808b-4becfb884789 59762-2701 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 20150131 ANDA ANDA091114 Greenstone LLC FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 59762-2703_36076206-b35f-450f-808b-4becfb884789 59762-2703 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 20150131 ANDA ANDA091114 Greenstone LLC FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 59762-2858_12a1ad22-dde7-41dc-aa83-bff8d595c173 59762-2858 HUMAN PRESCRIPTION DRUG EXEMESTANE Exemestane TABLET, SUGAR COATED ORAL 20110401 NDA AUTHORIZED GENERIC NDA020753 Greenstone LLC EXEMESTANE 25 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 59762-3051_1bf8152e-ddf3-40d2-a473-3a79de003649 59762-3051 HUMAN PRESCRIPTION DRUG azithromycin AZITHROMYCIN POWDER, FOR SUSPENSION ORAL 19990212 NDA NDA050693 Greenstone LLC AZITHROMYCIN DIHYDRATE 1 g/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 59762-3060_ad906f6e-4d8e-466e-87c8-6dd4a32f3f86 59762-3060 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 19960718 NDA AUTHORIZED GENERIC NDA050711 Greenstone LLC AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 59762-3070_ad906f6e-4d8e-466e-87c8-6dd4a32f3f86 59762-3070 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 20020524 NDA AUTHORIZED GENERIC NDA050784 Greenstone LLC AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 59762-3080_1bf8152e-ddf3-40d2-a473-3a79de003649 59762-3080 HUMAN PRESCRIPTION DRUG azithromycin AZITHROMYCIN TABLET, FILM COATED ORAL 19960612 NDA NDA050730 Greenstone LLC AZITHROMYCIN DIHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 59762-3110_ad906f6e-4d8e-466e-87c8-6dd4a32f3f86 59762-3110 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 19951019 NDA AUTHORIZED GENERIC NDA050710 Greenstone LLC AZITHROMYCIN DIHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 59762-3120_ad906f6e-4d8e-466e-87c8-6dd4a32f3f86 59762-3120 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 19951019 NDA AUTHORIZED GENERIC NDA050710 Greenstone LLC AZITHROMYCIN DIHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 59762-3130_ad906f6e-4d8e-466e-87c8-6dd4a32f3f86 59762-3130 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 19951019 NDA AUTHORIZED GENERIC NDA050710 Greenstone LLC AZITHROMYCIN DIHYDRATE 900 mg/22.5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 59762-3140_ad906f6e-4d8e-466e-87c8-6dd4a32f3f86 59762-3140 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 19951019 NDA AUTHORIZED GENERIC NDA050710 Greenstone LLC AZITHROMYCIN DIHYDRATE 1200 mg/30mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 59762-3304_70a56cb1-d40d-4134-87b6-767459d263ac 59762-3304 HUMAN PRESCRIPTION DRUG NITROGLYCERIN nitroglycerin TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20030408 NDA AUTHORIZED GENERIC NDA021134 Greenstone LLC NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 59762-3328_9c333f4f-1cad-47b8-a8e0-b16ba825c5f6 59762-3328 HUMAN PRESCRIPTION DRUG clindamycin hydrochloride clindamycin hydrochloride CAPSULE ORAL 19700522 NDA AUTHORIZED GENERIC NDA050162 Greenstone LLC CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 59762-3717_37ca456d-8988-4bff-ba38-410d5705933d 59762-3717 HUMAN PRESCRIPTION DRUG Triazolam triazolam TABLET ORAL 19821115 NDA AUTHORIZED GENERIC NDA017892 Greenstone LLC TRIAZOLAM .125 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 59762-3718_37ca456d-8988-4bff-ba38-410d5705933d 59762-3718 HUMAN PRESCRIPTION DRUG Triazolam triazolam TABLET ORAL 19821115 NDA AUTHORIZED GENERIC NDA017892 Greenstone LLC TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 59762-3719_c2a93a74-43f0-4335-b965-eb5b78e8d05c 59762-3719 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Greenstone LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 59762-3720_c2a93a74-43f0-4335-b965-eb5b78e8d05c 59762-3720 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Greenstone LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 59762-3721_c2a93a74-43f0-4335-b965-eb5b78e8d05c 59762-3721 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Greenstone LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 59762-3722_c2a93a74-43f0-4335-b965-eb5b78e8d05c 59762-3722 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Greenstone LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 59762-3728_742e5b26-8882-4cf2-94fa-dc6478d11743 59762-3728 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate SOLUTION TOPICAL 19800620 NDA AUTHORIZED GENERIC NDA050537 Greenstone LLC CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 59762-3740_79ce1a44-13af-4c4f-845a-0f35c6c99708 59762-3740 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE TABLET ORAL 19590603 NDA AUTHORIZED GENERIC NDA011839 Greenstone LLC MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 59762-3741_79ce1a44-13af-4c4f-845a-0f35c6c99708 59762-3741 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE TABLET ORAL 19590603 NDA AUTHORIZED GENERIC NDA011839 Greenstone LLC MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 59762-3742_79ce1a44-13af-4c4f-845a-0f35c6c99708 59762-3742 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE TABLET ORAL 19590603 NDA AUTHORIZED GENERIC NDA011839 Greenstone LLC MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 59762-3743_742e5b26-8882-4cf2-94fa-dc6478d11743 59762-3743 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate GEL TOPICAL 19870107 NDA AUTHORIZED GENERIC NDA050615 Greenstone LLC CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 59762-3744_742e5b26-8882-4cf2-94fa-dc6478d11743 59762-3744 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate LOTION TOPICAL 19890531 NDA AUTHORIZED GENERIC NDA050600 Greenstone LLC CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 59762-4320_a6ae8452-8ad5-4ed5-9e24-5eab016ab707 59762-4320 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 20151130 ANDA ANDA077095 Greenstone LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 59762-4321_a6ae8452-8ad5-4ed5-9e24-5eab016ab707 59762-4321 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 20151130 ANDA ANDA077095 Greenstone LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 59762-4322_a6ae8452-8ad5-4ed5-9e24-5eab016ab707 59762-4322 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 20151130 ANDA ANDA077095 Greenstone LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 59762-4440_ba5e4b00-8948-4481-bf8d-f9e2461038e7 59762-4440 HUMAN PRESCRIPTION DRUG Methylprednisolone methylprednisolone TABLET ORAL 20111011 NDA AUTHORIZED GENERIC NDA011153 Greenstone LLC METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 59762-4537_6f99d6aa-d70d-4f24-a813-bbf2a8756906 59762-4537 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19921029 NDA AUTHORIZED GENERIC NDA020246 Greenstone LLC MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 59762-4538_6f99d6aa-d70d-4f24-a813-bbf2a8756906 59762-4538 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19921029 NDA AUTHORIZED GENERIC NDA020246 Greenstone LLC MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 59762-4900_4ef5ae6d-5d37-4c84-a343-7e69de314a2a 59762-4900 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19920211 NDA AUTHORIZED GENERIC NDA019839 Greenstone LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59762-4910_4ef5ae6d-5d37-4c84-a343-7e69de314a2a 59762-4910 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19920211 NDA AUTHORIZED GENERIC NDA019839 Greenstone LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59762-4921_70a56cb1-d40d-4134-87b6-767459d263ac 59762-4921 HUMAN PRESCRIPTION DRUG NITROGLYCERIN nitroglycerin TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20030408 NDA AUTHORIZED GENERIC NDA021134 Greenstone LLC NITROGLYCERIN .3 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 59762-4940_4ef5ae6d-5d37-4c84-a343-7e69de314a2a 59762-4940 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE ORAL 19920211 NDA AUTHORIZED GENERIC NDA020990 Greenstone LLC SERTRALINE HYDROCHLORIDE 20 mg/mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59762-4960_4ef5ae6d-5d37-4c84-a343-7e69de314a2a 59762-4960 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19920211 NDA AUTHORIZED GENERIC NDA019839 Greenstone LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 59762-5000_5705824b-969f-42a0-9819-7b0fe8f62a00 59762-5000 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20030701 NDA AUTHORIZED GENERIC NDA007073 Greenstone LLC SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 59762-5007_304f7036-6da3-407d-9a82-3137f1ae5bd7 59762-5007 HUMAN PRESCRIPTION DRUG misoprostol MISOPROSTOL TABLET ORAL 20091227 NDA AUTHORIZED GENERIC NDA019268 Greenstone LLC MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 59762-5008_304f7036-6da3-407d-9a82-3137f1ae5bd7 59762-5008 HUMAN PRESCRIPTION DRUG misoprostol MISOPROSTOL TABLET ORAL 20091227 NDA AUTHORIZED GENERIC NDA019268 Greenstone LLC MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 59762-5009_f9b81df1-2287-46a8-ab01-4d8d0f22c999 59762-5009 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate CREAM VAGINAL 19920811 NDA AUTHORIZED GENERIC NDA050680 Greenstone LLC CLINDAMYCIN PHOSPHATE 20 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 59762-5010_9c333f4f-1cad-47b8-a8e0-b16ba825c5f6 59762-5010 HUMAN PRESCRIPTION DRUG clindamycin hydrochloride clindamycin hydrochloride CAPSULE ORAL 19700522 NDA AUTHORIZED GENERIC NDA050162 Greenstone LLC CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 59762-5011_0fd3c720-c5eb-4420-b1ec-58166e56e053 59762-5011 HUMAN PRESCRIPTION DRUG spironolactone SPIRONOLACTONE TABLET, FILM COATED ORAL 19600121 NDA AUTHORIZED GENERIC NDA012151 Greenstone LLC SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 59762-5012_0fd3c720-c5eb-4420-b1ec-58166e56e053 59762-5012 HUMAN PRESCRIPTION DRUG spironolactone SPIRONOLACTONE TABLET, FILM COATED ORAL 19600121 NDA AUTHORIZED GENERIC NDA012151 Greenstone LLC SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 59762-5013_0fd3c720-c5eb-4420-b1ec-58166e56e053 59762-5013 HUMAN PRESCRIPTION DRUG spironolactone SPIRONOLACTONE TABLET, FILM COATED ORAL 19600121 NDA AUTHORIZED GENERIC NDA012151 Greenstone LLC SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 59762-5014_38603d06-fc19-47c8-97dc-4a2c74c5e6c7 59762-5014 HUMAN PRESCRIPTION DRUG Spironolactone and Hydrochlorothiazide spironolactone and hydrochlorothiazide TABLET, FILM COATED ORAL 19780101 NDA AUTHORIZED GENERIC NDA012616 Greenstone LLC HYDROCHLOROTHIAZIDE; SPIRONOLACTONE 25; 25 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 59762-5015_58f31109-a89d-417e-ab2c-8af569a85b6e 59762-5015 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 19900129 NDA AUTHORIZED GENERIC NDA019949 Greenstone LLC FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 59762-5016_58f31109-a89d-417e-ab2c-8af569a85b6e 59762-5016 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 19900129 NDA AUTHORIZED GENERIC NDA019949 Greenstone LLC FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 59762-5017_58f31109-a89d-417e-ab2c-8af569a85b6e 59762-5017 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 19900129 NDA AUTHORIZED GENERIC NDA019949 Greenstone LLC FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 59762-5018_58f31109-a89d-417e-ab2c-8af569a85b6e 59762-5018 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 19900129 NDA AUTHORIZED GENERIC NDA019949 Greenstone LLC FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 59762-5019_c57145c1-4ec2-4142-88df-70befe61af6f 59762-5019 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA AUTHORIZED GENERIC NDA019885 Greenstone LLC QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 59762-5020_c57145c1-4ec2-4142-88df-70befe61af6f 59762-5020 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA AUTHORIZED GENERIC NDA019885 Greenstone LLC QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 59762-5021_c57145c1-4ec2-4142-88df-70befe61af6f 59762-5021 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA AUTHORIZED GENERIC NDA019885 Greenstone LLC QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 59762-5022_c57145c1-4ec2-4142-88df-70befe61af6f 59762-5022 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA AUTHORIZED GENERIC NDA019885 Greenstone LLC QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 59762-5023_2a08fd33-2a88-4366-b490-0bde139bce01 59762-5023 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin TABLET, FILM COATED ORAL 19981009 NDA AUTHORIZED GENERIC NDA020882 Greenstone LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59762-5024_2a08fd33-2a88-4366-b490-0bde139bce01 59762-5024 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin TABLET, FILM COATED ORAL 19981009 NDA AUTHORIZED GENERIC NDA020882 Greenstone LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59762-5025_2a08fd33-2a88-4366-b490-0bde139bce01 59762-5025 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin SUSPENSION ORAL 20110329 NDA AUTHORIZED GENERIC NDA021129 Greenstone LLC GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59762-5026_2a08fd33-2a88-4366-b490-0bde139bce01 59762-5026 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin CAPSULE ORAL 19931230 NDA AUTHORIZED GENERIC NDA020235 Greenstone LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59762-5027_2a08fd33-2a88-4366-b490-0bde139bce01 59762-5027 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin CAPSULE ORAL 19931230 NDA AUTHORIZED GENERIC NDA020235 Greenstone LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59762-5028_2a08fd33-2a88-4366-b490-0bde139bce01 59762-5028 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin CAPSULE ORAL 19931230 NDA AUTHORIZED GENERIC NDA020235 Greenstone LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59762-5029_58f31109-a89d-417e-ab2c-8af569a85b6e 59762-5029 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole POWDER, FOR SUSPENSION ORAL 19931223 NDA AUTHORIZED GENERIC NDA020090 Greenstone LLC FLUCONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 59762-5030_58f31109-a89d-417e-ab2c-8af569a85b6e 59762-5030 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole POWDER, FOR SUSPENSION ORAL 19931223 NDA AUTHORIZED GENERIC NDA020090 Greenstone LLC FLUCONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 59762-5032_164199cd-fc2b-4590-ae53-9b5ed03c9751 59762-5032 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 20040611 20170331 NDA AUTHORIZED GENERIC NDA020329 Greenstone LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 59762-5033_164199cd-fc2b-4590-ae53-9b5ed03c9751 59762-5033 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 20040611 NDA AUTHORIZED GENERIC NDA020329 Greenstone LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 59762-5091_3d69a668-3124-4002-9822-84e52314c573 59762-5091 HUMAN PRESCRIPTION DRUG epirubicin hydrochloride epirubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 19990915 NDA AUTHORIZED GENERIC NDA050778 Greenstone, LLC EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 59762-5093_3d69a668-3124-4002-9822-84e52314c573 59762-5093 HUMAN PRESCRIPTION DRUG epirubicin hydrochloride epirubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 19990915 NDA AUTHORIZED GENERIC NDA050778 Greenstone, LLC EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 59762-5210_be8724f5-1516-4911-9481-b52c14bc6916 59762-5210 HUMAN PRESCRIPTION DRUG Phenytoin Infatabs Phenytoin TABLET, CHEWABLE ORAL 20121227 ANDA ANDA084427 Greenstone LLC PHENYTOIN 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 59762-6002_9a04b34b-9e11-49dd-8097-6bf9fe9e4a7c 59762-6002 HUMAN PRESCRIPTION DRUG oxaprozin OXAPROZIN TABLET, FILM COATED ORAL 20130328 NDA AUTHORIZED GENERIC NDA018841 Greenstone LLC OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 59762-6690_2134f93f-cbfd-40aa-819d-54ade221136c 59762-6690 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100331 NDA AUTHORIZED GENERIC NDA019684 Greenstone LLC NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 59762-6691_2134f93f-cbfd-40aa-819d-54ade221136c 59762-6691 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100331 NDA AUTHORIZED GENERIC NDA019684 Greenstone LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 59762-6692_2134f93f-cbfd-40aa-819d-54ade221136c 59762-6692 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100331 NDA AUTHORIZED GENERIC NDA019684 Greenstone LLC NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 59762-6710_88b9b5da-5dec-42b4-9146-466b7e880668 59762-6710 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59762-6711_88b9b5da-5dec-42b4-9146-466b7e880668 59762-6711 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59762-6712_88b9b5da-5dec-42b4-9146-466b7e880668 59762-6712 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59762-6720_88b9b5da-5dec-42b4-9146-466b7e880668 59762-6720 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59762-6721_88b9b5da-5dec-42b4-9146-466b7e880668 59762-6721 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59762-6722_88b9b5da-5dec-42b4-9146-466b7e880668 59762-6722 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59762-6723_88b9b5da-5dec-42b4-9146-466b7e880668 59762-6723 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59762-6730_88b9b5da-5dec-42b4-9146-466b7e880668 59762-6730 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59762-6731_88b9b5da-5dec-42b4-9146-466b7e880668 59762-6731 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59762-6732_88b9b5da-5dec-42b4-9146-466b7e880668 59762-6732 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59762-6733_88b9b5da-5dec-42b4-9146-466b7e880668 59762-6733 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 59764-522_2eb8e2af-3d59-417f-b83d-8a0e8f19688a 59764-522 HUMAN OTC DRUG NovaClenz Instant Hand Sanitizer ALCOHOL SOAP TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333E Micronova ALCOHOL .62 mL/mL 59767-004_bbaaec47-a06a-4827-aa33-259e99639739 59767-004 HUMAN PRESCRIPTION DRUG PERTZYE pancrelipase CAPSULE, DELAYED RELEASE ORAL 20120517 NDA NDA022175 Digestive Care, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 15125; 4000; 14375 [USP'U]/1; [USP'U]/1; [USP'U]/1 59767-008_bbaaec47-a06a-4827-aa33-259e99639739 59767-008 HUMAN PRESCRIPTION DRUG PERTZYE pancrelipase CAPSULE, DELAYED RELEASE ORAL 20120517 NDA NDA022175 Digestive Care, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 30250; 8000; 28750 [USP'U]/1; [USP'U]/1; [USP'U]/1 59767-016_bbaaec47-a06a-4827-aa33-259e99639739 59767-016 HUMAN PRESCRIPTION DRUG PERTZYE pancrelipase CAPSULE, DELAYED RELEASE ORAL 20120517 NDA NDA022175 Digestive Care, Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 60500; 16000; 57500 [USP'U]/1; [USP'U]/1; [USP'U]/1 59779-000_349db38d-ecdb-4cde-a609-c34bafb851a4 59779-000 HUMAN OTC DRUG CVS SPF 8 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20121211 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTINOXATE; OXYBENZONE 5; 2 g/100g; g/100g 59779-001_6d7054d9-955c-4d54-b00d-a80a6bd5298b 59779-001 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20040507 ANDA ANDA076359 CVS Pharmacy IBUPROFEN 100 mg/1 59779-002_a02a38bd-4775-4370-b0e1-040feab2c18f 59779-002 HUMAN OTC DRUG enema Saline ENEMA RECTAL 20091125 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 59779-003_bbabd079-49bb-42bb-9e31-44e6a68674c1 59779-003 HUMAN OTC DRUG Poly Bacitracin bacitracin zinc, polymyxin B sulfate OINTMENT TOPICAL 20050103 OTC MONOGRAPH FINAL part333B CVS Pharmacy BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [iU]/g; [iU]/g 59779-004_4faa45f8-0b82-41a7-9bc7-494bee362170 59779-004 HUMAN OTC DRUG Anticavity Fluoride Rinse Anticavity Rinse MOUTHWASH ORAL 20040408 OTC MONOGRAPH FINAL part355 CVS Pharmacy, Inc SODIUM FLUORIDE .02 kg/100L 59779-005_8d108556-3005-4a17-aa5c-8620db6d7467 59779-005 HUMAN OTC DRUG CVS Triple-Thick Antibacterial Washcloths Benzalkonium Chloride CLOTH TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE .12 g/100mL 59779-006_f7285833-3e35-4711-9ec6-8608d395d276 59779-006 HUMAN OTC DRUG CVS Pharmacy Childrens GLYCERIN SUPPOSITORIES LAXATIVE Glycerin LIQUID RECTAL 20020603 OTC MONOGRAPH NOT FINAL part334 CVS PHARMACY, INC. GLYCERIN 2.8 g/1 59779-007_b0970abe-8acc-4b41-93e6-aa28d761ae3a 59779-007 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090209 OTC MONOGRAPH FINAL part333 CVS ISOPROPYL ALCOHOL 70 mL/100mL 59779-008_00708ca5-d42d-48af-89fc-43534b318d9c 59779-008 HUMAN OTC DRUG infants pain relief concentrated Acetaminophen SUSPENSION/ DROPS ORAL 19960805 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 80 mg/.8mL 59779-009_643ddd8f-aada-4c4e-a690-0257d7c05929 59779-009 HUMAN OTC DRUG CVS Pharmacy GLYCERIN SUPPOSITORIES LAXATIVE Glycerin LIQUID RECTAL 20020603 OTC MONOGRAPH NOT FINAL part334 CVS PHARMACY, INC. GLYCERIN 5.4 g/1 59779-010_733c947e-5a6f-42cc-8cfc-2d3e3445a9df 59779-010 HUMAN OTC DRUG Antacid Anti-Gas Aluminum Hydroxide, Magnesium Hydroxide, Demithicone SUSPENSION ORAL 20090429 OTC MONOGRAPH FINAL part331 CVS ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 59779-011_fcc0b98b-c2ba-4e7d-b7b8-2bd15d150dfd 59779-011 HUMAN OTC DRUG Antacid Liquid Mint Aluminum Hydroxide, Magnesium Hydroxide, Demithicone SUSPENSION ORAL 20090210 OTC MONOGRAPH FINAL part331 CVS ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 59779-012_62255f6a-d9d9-4eaa-8bec-2607f3086710 59779-012 HUMAN OTC DRUG Antacid Antigas Maximum Strength ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE SUSPENSION ORAL 20090210 OTC MONOGRAPH FINAL part331 CVS ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 59779-013_bba10b79-1947-410c-b842-2a2908423bb9 59779-013 HUMAN OTC DRUG Allergy Relief d 12 Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120125 ANDA ANDA076050 CVS Pharmacy LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 59779-014_e0e87346-f1e2-46c6-9ec8-f9f943ea7380 59779-014 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20091022 OTC MONOGRAPH NOT FINAL part356 CVS HYDROGEN PEROXIDE 2.65 mL/100mL 59779-015_2db13ae5-c854-4d72-9c9c-e29003d269e9 59779-015 HUMAN OTC DRUG Antacid Supreme ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE SUSPENSION ORAL 20090107 OTC MONOGRAPH FINAL part331 CVS ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE 400; 135 mg/5mL; mg/5mL 59779-016_be94846c-698a-4c0f-8ef6-413d8da12a37 59779-016 HUMAN OTC DRUG PYRITHIONE ZINC PYRITHIONE ZINC LIQUID TOPICAL 20100716 OTC MONOGRAPH FINAL part358H CVS Pharmacy PYRITHIONE ZINC 29 mg/mL 59779-017_728fce0a-459f-43a1-b0f9-1fea8917051b 59779-017 HUMAN OTC DRUG CVS Pharmacy Sport SPF 50 AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121218 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 8; 4 g/100g; g/100g; g/100g 59779-018_1a57bebb-1d8c-48d1-9cb0-f790386479e0 59779-018 HUMAN OTC DRUG Milk of Magnesia Original MAGNESIUM HYDROXIDE SUSPENSION ORAL 20090528 OTC MONOGRAPH FINAL part334 CVS MAGNESIUM HYDROXIDE 1200 mg/15mL 59779-019_09e1e6e6-87bd-4912-b190-a447511af0c0 59779-019 HUMAN OTC DRUG ALLERGY Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part336 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59779-020_fde79288-fa83-4347-8a12-0d6c4189ddba 59779-020 HUMAN OTC DRUG CVS Pharmacy Sunscreen SPF 45 OCTINOXATE, OCTOCRLYENE, ZINC OXIDE LOTION TOPICAL 20121217 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 7.5; 8; 6.8 g/100g; g/100g; g/100g 59779-021_b49ee8e9-5675-4572-bdec-3409ae599ebe 59779-021 HUMAN OTC DRUG CVS Pharmacy Oil Free SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g 59779-022_464b1dec-3220-471c-b067-a06a87fb8cae 59779-022 HUMAN OTC DRUG heartburn relief Cimetidine TABLET ORAL 20000114 ANDA ANDA075285 CVS Pharmacy CIMETIDINE 200 mg/1 59779-023_b6d9fbc6-7121-4f20-b78b-10a3a9682788 59779-023 HUMAN OTC DRUG CVS Pharmacy Oil Free Faces SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121213 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 8; 5; 5; 4 g/100g; g/100g; g/100g; g/100g; g/100g 59779-024_cbb61bf0-ab8a-41d7-a115-8f37403c74cb 59779-024 HUMAN OTC DRUG CVS Pharmacy SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g 59779-025_ece748cd-567e-4dd4-9b6b-5286f99eda99 59779-025 HUMAN OTC DRUG CVS Pharmacy SPF 15 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTINOXATE; OXYBENZONE 7.5; 4.5 g/100g; g/100g 59779-026_49ded20b-c0c4-48d7-811b-d96e9df848d5 59779-026 HUMAN OTC DRUG CVS Clear Zinc SPF 50 OCTOCRYLENE, ZINC OXIDE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTOCRYLENE; ZINC OXIDE 4; 5 g/100g; g/100g 59779-027_60766d35-9930-43f4-ae52-a5675cd60837 59779-027 HUMAN OTC DRUG allergy eye Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20110107 ANDA ANDA077958 CVS Pharmacy KETOTIFEN FUMARATE .25 mg/mL 59779-028_be163877-e24b-49df-8431-209ce30643fb 59779-028 HUMAN OTC DRUG CVS Pharmacy Oil Free SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g 59779-029_b12ac75a-2ebf-437c-ae97-43fd170508c5 59779-029 HUMAN OTC DRUG nicotine stop smoking aid Nicotine Polacrilex GUM, CHEWING ORAL 20050707 ANDA ANDA076775 CVS Pharmacy NICOTINE 2 mg/1 59779-030_7b3f26c4-3d57-4717-a860-b66b5982b661 59779-030 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090923 OTC MONOGRAPH FINAL part356 CVS HYDROGEN PEROXIDE 2.65 mL/100mL 59779-031_01429ab7-896c-415e-a9d5-a19627936740 59779-031 HUMAN OTC DRUG daytime cough nighttime cough dextromethorphan HBr, doxylamine succinate KIT 20120807 OTC MONOGRAPH FINAL part341 CVS Pharmacy 59779-032_208c8aa2-ee83-4ddb-a6e6-f5eaaee7a58f 59779-032 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20101214 OTC MONOGRAPH FINAL part333D CVS Pharmacy, Inc SALICYLIC ACID 19.8 mg/g 59779-033_fdbae905-cbe0-43a2-91bc-c9e63a37896a 59779-033 HUMAN OTC DRUG Cortisone Maximum Strength with Aloe Hydrocortisone CREAM TOPICAL 20060510 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy HYDROCORTISONE 1 g/100g 59779-034_f094a7a9-abd2-4063-8580-e2f2c640e450 59779-034 HUMAN OTC DRUG Cortisone Maximum Strength Hydrocortisone OINTMENT TOPICAL 20060425 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy HYDROCORTISONE 1 g/100g 59779-035_d585964d-4576-42d8-aa81-ca6fdd24a96b 59779-035 HUMAN OTC DRUG Minoxidil Minoxidil AEROSOL, FOAM TOPICAL 20140429 ANDA ANDA091344 CVS Pharmacy MINOXIDIL 5 g/100g 59779-036_0b9a0867-5d7a-4e04-a95f-0ea31bf05702 59779-036 HUMAN OTC DRUG CVS pharmacy Clinical Strength Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20111020 OTC MONOGRAPH FINAL part350 CVS pharmacy ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g 59779-037_415426b8-6bc4-4c2f-8be5-95010c462614 59779-037 HUMAN OTC DRUG CVS pharmacy Clinical Strength Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130801 OTC MONOGRAPH FINAL part350 CVS pharmacy ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g 59779-038_2fcec747-b9b4-45a3-81ea-305ae14e0981 59779-038 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130730 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM 100 mg/1 59779-039_f11dfc3e-27ed-43b5-981e-9617e4ed0ef1 59779-039 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM 100 mg/1 59779-040_2545603d-4d5e-414c-a840-bcbdfd6b6443 59779-040 HUMAN OTC DRUG Night Time Cherry DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20090819 OTC MONOGRAPH FINAL part341 CVS DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 135 mg/15mL; mg/5mL 59779-041_e90fb7b3-994b-48a9-a115-a88af61ab3ef 59779-041 HUMAN OTC DRUG CVS Nighttime Cold/Flu Relief acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090709 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 59779-042_35a6bb06-efa2-4482-938b-66b6d41ab823 59779-042 HUMAN OTC DRUG Eye Allergy Relief Pheniramine Maleate and Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20100831 NDA NDA020065 CVS Pharmacy NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL 59779-043_f4140cf5-c2ba-435d-bd42-c757cad81276 59779-043 HUMAN OTC DRUG Motion Sickness II Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED MECLIZINE HYDROCHLORIDE 25 mg/1 59779-044_e336231b-36c0-475c-b636-6e66af50cf05 59779-044 HUMAN OTC DRUG CVS Pharmacy Pre-measured spoon Childrens ALLERGY MEDICATION Diphenhydramine Hydrochloride LIQUID ORAL 20110825 OTC MONOGRAPH FINAL part341 CVS PHARMACY, INC. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 59779-045_b73cf187-2f59-4da2-8b01-23d3f95a2ab4 59779-045 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 20110404 OTC MONOGRAPH FINAL part346 CVS Pharmacy WITCH HAZEL 979 mg/mL 59779-046_97e70c0b-2a96-4659-b36f-f73d94b92c5a 59779-046 HUMAN OTC DRUG Cold and Flu HBP Acetaminophen and Chlorpheniramine Maleate TABLET, COATED ORAL 20050531 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 325; 2 mg/1; mg/1 59779-047_6d140eec-69cc-412b-9735-17770f7deaea 59779-047 HUMAN OTC DRUG Tussin CF Maximum Strength dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20140531 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL 59779-048_e6a992c0-58b2-4ac5-9216-88fa5d817f75 59779-048 HUMAN OTC DRUG CVS Maximum Strength Itch Relief DIPHENHYDRAMINE HYDROCHLORIDE GEL TOPICAL 20110810 OTC MONOGRAPH FINAL part336 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 20.5 mg/mL 59779-049_e1a5e2db-9623-49e1-9182-55f545ce7363 59779-049 HUMAN OTC DRUG Muscle Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20050613 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g 59779-050_07fe08cb-cfa1-482a-a172-a4f8897e3a31 59779-050 HUMAN OTC DRUG ibuprofen pm diphenhydramine citrate and ibuprofen TABLET, COATED ORAL 20090217 ANDA ANDA079113 CVS Pharmacy DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 59779-051_d8f0f29b-38db-470e-8960-f8a59a532f70 59779-051 HUMAN OTC DRUG CVS Soothing Itch Relief MENTHOL LOTION TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy MENTHOL 1 mg/mL 59779-052_c190935b-2f94-4c11-b531-f5726ea0904e 59779-052 HUMAN OTC DRUG CVS Fragrance Free Anti-Itch PRAMOXINE HYDROCHLORIDE LOTION TOPICAL 20100708 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy PRAMOXINE HYDROCHLORIDE 10 mg/mL 59779-053_06fe2623-5c94-44f5-be30-57ec400e8a34 59779-053 HUMAN OTC DRUG CVS Extra Strength Itch Relief DIPHENHYDRAMINE HYDROCHLORIDE and ZINC ACETATE OINTMENT TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 12 mg/g; mg/g 59779-054_3d2cbee9-67ca-4d56-b082-53a3b7129af4 59779-054 HUMAN OTC DRUG CVS Vanishing Scent Muscle Rub MENTHOL GEL TOPICAL 20110314 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy MENTHOL 27.5 mg/g 59779-055_04d696fc-a872-4988-bd20-2ae3d7ffd55b 59779-055 HUMAN OTC DRUG CVS Acne Spot Treatment SALICYLIC ACID GEL TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part333D CVS Pharmacy SALICYLIC ACID 20 mg/mL 59779-056_3279cb81-6ab0-4c53-866c-da71484c4eea 59779-056 HUMAN OTC DRUG CVS Therapeutic Menthol Pain Reliever MENTHOL GEL TOPICAL 20100710 OTC MONOGRAPH FINAL part348 CVS Pharmacy MENTHOL 20 mg/g 59779-057_88ba2bcb-3df2-4411-8410-f03897589923 59779-057 HUMAN OTC DRUG CVS Chest Rub CAMPHOR, EUCALYPTUS OIL and MENTHOL OINTMENT TOPICAL 20110114 OTC MONOGRAPH FINAL part341 CVS Pharmacy CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 48; 12; 26 mg/g; mg/g; mg/g 59779-058_9100c792-70b6-43fe-b8a4-a49a61de6d87 59779-058 HUMAN OTC DRUG CAMPHOR CAMPHOR LIQUID RESPIRATORY (INHALATION) 20090519 OTC MONOGRAPH NOT FINAL part348 CVS CAMPHOR (SYNTHETIC) 155 mg/mL 59779-059_6bdb9d8f-7175-431f-a339-8af332f7afac 59779-059 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc ALCOHOL 70 mL/100mL 59779-060_f4365276-0f29-4e0f-9f0d-478c5a6cd4b6 59779-060 HUMAN OTC DRUG Witch Hazel Witch Hazel OIL ORAL; TOPICAL 20090714 OTC MONOGRAPH FINAL part346 CVS WITCH HAZEL 86 mL/100mL 59779-061_3df94466-840f-4bd0-84f8-4cdb044aa46d 59779-061 HUMAN OTC DRUG all day pain relief Naproxen sodium TABLET, FILM COATED ORAL 20050926 ANDA ANDA074661 CVS Pharmacy NAPROXEN SODIUM 220 mg/1 59779-062_0429b28f-c5f3-49e0-9b7d-f41f836f17b5 59779-062 HUMAN OTC DRUG CVS Pharmacy Clotrimazole 3 Clotrimazole CREAM VAGINAL 20000412 NDA NDA021143 CVS Pharmacy CLOTRIMAZOLE 2 g/100g 59779-063_20261826-4c12-4497-bc95-3a2511f61f5c 59779-063 HUMAN OTC DRUG CVS Advanced Deep Set Wrinkle Therapy w/SPF15 ENSULIZOLE AND OCTINOXATE LOTION TOPICAL 20110719 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy ENSULIZOLE; OCTINOXATE 18; 75 mg/mL; mg/mL 59779-064_5578f6cf-3b09-45eb-a98e-f5d8bc65e95e 59779-064 HUMAN OTC DRUG CVS Pharmacy Cough Relief Honey Lemon Flavor DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL LOZENGE ORAL 20140519 OTC MONOGRAPH FINAL part341 CVS Pharmacy, Inc. DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL 5; 5 mg/1; mg/1 59779-065_e71815e7-05ca-4698-9f09-72d711ae9b22 59779-065 HUMAN OTC DRUG nasal Oxymetazoline HCl SPRAY NASAL 19940701 OTC MONOGRAPH FINAL part341 CVS Pharmacy OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 59779-066_7bad3e08-2b85-4603-ad1d-48635d488a0e 59779-066 HUMAN OTC DRUG Minoxidil for Women Minoxidil SOLUTION TOPICAL 20030101 ANDA ANDA074588 CVS MINOXIDIL 2 g/100mL 59779-067_808a454c-4394-4225-8cb9-b5312afe5288 59779-067 HUMAN OTC DRUG ANTIBIOTIC ORIGINAL STRENGTH bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20050608 OTC MONOGRAPH FINAL part333B CVS Pharmacy BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 59779-068_8129e947-b93c-4c38-aa55-5a83d3798436 59779-068 HUMAN OTC DRUG PETROLATUM, LANOLIN PETROLATUM, LANOLIN OINTMENT TOPICAL 20090519 OTC MONOGRAPH FINAL part347 CVS LANOLIN; PETROLATUM .155; .534 g/g; g/g 59779-069_f4feb9f1-8dbf-4bd6-9a3e-af07575512eb 59779-069 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 19920715 OTC MONOGRAPH FINAL part347 CVS Pharmacy PETROLATUM 1 g/g 59779-070_ba5a7bd9-4ade-47a4-9ffc-25949103b2c2 59779-070 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20131018 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc ALCOHOL 700 mg/mL 59779-071_5a985361-a546-4e7b-9870-af718929b25a 59779-071 HUMAN OTC DRUG MENTHOL AND METHYL SALICYLATE MENTHOL AND METHYL SALICYLATE OINTMENT TOPICAL 20110214 OTC MONOGRAPH FINAL part356 CVS MENTHOL; METHYL SALICYLATE 100; 28 mg/g; mg/g 59779-072_4ff63538-12be-4ee2-9e12-7d5c0f61ecaa 59779-072 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol MOUTHWASH ORAL 19950809 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 59779-073_0b258b2c-0f08-40df-8a4d-28d4f50db131 59779-073 HUMAN OTC DRUG CVS Clarifying Body Wash SALICYLIC ACID SOAP TOPICAL 20100710 OTC MONOGRAPH FINAL part333D CVS Pharmacy SALICYLIC ACID 20 mg/mL 59779-074_116e13c1-ac50-400f-880f-5779f0155b96 59779-074 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 20060217 ANDA ANDA077349 CVS Pharmacy IBUPROFEN 200 mg/1 59779-075_74a45491-238b-48bf-8b14-569e1df61fef 59779-075 HUMAN OTC DRUG Cromolyn Sodium Cromolyn Sodium SPRAY, METERED NASAL 20010703 ANDA ANDA075702 CVS Pharmacy CROMOLYN SODIUM 5.2 mg/mL 59779-076_d5f7a507-afb8-432b-8508-920d2de48415 59779-076 HUMAN OTC DRUG CVS Fast Clearing Medicated Pads SALICYLIC ACID SWAB TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333D CVS PHARMACY SALICYLIC ACID 21 mg/1 59779-077_3032b9b8-012e-4148-be34-a0e52d4809db 59779-077 HUMAN OTC DRUG CVS Daily Pore Clearing Pads SALICYLIC ACID SWAB TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333D CVS PHARMACY SALICYLIC ACID 21 mg/1 59779-078_133e11e4-2ec4-4e9c-9d95-ac8d386d90d2 59779-078 HUMAN OTC DRUG SALICYLIC ACID SALICYLIC ACID LIQUID TOPICAL 20090519 OTC MONOGRAPH FINAL part333D CVS SALICYLIC ACID 5 mg/mL 59779-079_ead5a604-b4d4-459d-b01f-f166f10df07d 59779-079 HUMAN OTC DRUG Clean Apple Pyrithione zinc SHAMPOO TOPICAL 20131206 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc PYRITHIONE ZINC 1 g/mL 59779-080_9587898c-9e79-491d-b88d-fe97044b7778 59779-080 HUMAN OTC DRUG CVS Pharmacy Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 CVS Pharmacy TERBINAFINE HYDROCHLORIDE 1 g/100g 59779-081_4806c610-7f72-49cc-9419-7b6bd264d171 59779-081 HUMAN OTC DRUG TRICLOSAN TRICLOSAN LIQUID TOPICAL 20080601 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy TRICLOSAN 29 mg/mL 59779-082_1d59fe5c-0280-435a-acb2-08bf20162755 59779-082 HUMAN OTC DRUG DIMETHICONE and ZINC OXIDE DIMETHICONE and ZINC OXIDE OINTMENT TOPICAL 20090601 OTC MONOGRAPH FINAL part347 CVS DIMETHICONE; ZINC OXIDE 10; 100 mg/g; mg/g 59779-083_bcd1940d-100a-4572-be93-6cbb381b5105 59779-083 HUMAN OTC DRUG ZINC OXIDE ZINC OXIDE OINTMENT TOPICAL 20090519 OTC MONOGRAPH FINAL part347 CVS ZINC OXIDE 160 mg/g 59779-084_3b795a50-bb86-4233-a22d-f6ec7f374b4c 59779-084 HUMAN OTC DRUG CVS PHARMACY ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131002 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL 59779-084_443a0806-9a2c-40f8-8ac6-16a701db0173 59779-084 HUMAN OTC DRUG CVS PHARMACY ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131009 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL 59779-084_61f073dc-e1bf-4e0b-bda7-a13060716595 59779-084 HUMAN OTC DRUG CVS PHARMACY ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131208 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL 59779-084_db122365-4943-4c4e-8528-3d17dc00fb30 59779-084 HUMAN OTC DRUG CVS PHARMACY ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131126 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL 59779-085_e77febb7-201f-4252-85f3-c7d6908373fe 59779-085 HUMAN OTC DRUG POVIDONE IODINE POVIONE IODINE OINTMENT TOPICAL 20080730 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy POVIDONE-IODINE 1 g/10g 59779-086_824735a9-5e98-410d-b92e-8a2c2c86d365 59779-086 HUMAN OTC DRUG Advanced Healing Petrolatum OINTMENT TOPICAL 20090105 OTC MONOGRAPH FINAL part347 CVS Pharamacy, Inc PETROLATUM 340 mg/100g 59779-087_e988d5c9-01cb-4144-be25-16461399a2b6 59779-087 HUMAN OTC DRUG nicotine polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20050708 ANDA ANDA078326 CVS Pharmacy NICOTINE 4 mg/1 59779-088_4c3f3bbf-4bc8-4637-afdb-338d3817e878 59779-088 HUMAN OTC DRUG CAMPHOR (SYNTHETIC) and PHENOL CAMPHOR (SYNTHETIC) and PHENOL GEL TOPICAL 20090519 OTC MONOGRAPH FINAL part348 CVS CAMPHOR (SYNTHETIC); PHENOL 108; 47 mg/g; mg/g 59779-089_41c54c5d-f9b6-4571-bc43-f8e313396197 59779-089 HUMAN OTC DRUG Miconazole Nitrate Antifungal Powder Miconazole Nitrate POWDER TOPICAL 20140101 OTC MONOGRAPH FINAL part333C CVS Pharmacy MICONAZOLE NITRATE 1.42 g/71g 59779-090_894c0ee5-0e1a-4c71-963b-98de24fb74b5 59779-090 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090603 OTC MONOGRAPH FINAL part333 CVS ISOPROPYL ALCOHOL 70 mL/100mL 59779-091_4daba76f-9794-4dad-9f32-ebca1d8d9c7b 59779-091 HUMAN OTC DRUG All Day Moisture Octinoxate LOTION TOPICAL 20060228 OTC MONOGRAPH FINAL part352 CVS Pharmacy, Inc OCTINOXATE; ZINC OXIDE 60; 30 mg/mL; mg/mL 59779-092_4e851a7f-1513-42f4-83e8-3ba88ada24a6 59779-092 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090603 OTC MONOGRAPH FINAL part333 CVS ISOPROPYL ALCOHOL 70 mL/100mL 59779-093_a4f6ef22-a56f-4fae-a0f0-f504993c7070 59779-093 HUMAN OTC DRUG Childrens Allergy Relief Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 CVS Pharmacy LORATADINE 5 mg/5mL 59779-094_fdb5268a-ff1b-4eb9-9e04-bd7623a119d9 59779-094 HUMAN OTC DRUG nasal decongestant pe non drowsy Phenylephrine Hydrochloride TABLET ORAL 20050217 OTC MONOGRAPH FINAL part341 CVS Pharmacy PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 59779-095_d56ea12b-9534-47c1-8ef2-c0b9174c95af 59779-095 HUMAN OTC DRUG TUSSIN CF NIGHTTIME COUGH and COLD acetaminophen, diphenhydramine HCl, phenylephrine HCl LIQUID ORAL 20140731 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 640; 25; 10 mg/20mL; mg/20mL; mg/20mL 59779-096_e39ce501-4ff3-447d-b092-288fb1a390e1 59779-096 HUMAN OTC DRUG Flu and Severe Cold and Cough daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20120117 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 59779-097_5bd31dd5-13c7-4262-ad34-c4a25a01fd33 59779-097 HUMAN OTC DRUG Miconazole Nitrate Athletes Foot Spray AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH FINAL part333C CVS Pharmacy MICONAZOLE NITRATE 3 g/150g 59779-098_eea14fa9-9c3c-4b8a-b8d0-3bdd468dd7ff 59779-098 HUMAN OTC DRUG PETROLATUM and LANOLIN PETROLATUM and LANOLIN OINTMENT TOPICAL 20090519 OTC MONOGRAPH FINAL part347 CVS LANOLIN; PETROLATUM 155; 534 mg/g; mg/g 59779-099_cbfabacb-882f-4911-b804-79006e056afe 59779-099 HUMAN OTC DRUG CVS Cortisone Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy HYDROCORTISONE 1 g/100g 59779-100_d94fdf70-1f2f-4004-a735-5b9a8800a810 59779-100 HUMAN OTC DRUG CVS Pharmacy Instant Hand Sanitizer With Moisturizers And Vitamin E ALCOHOL GEL TOPICAL 20091210 OTC MONOGRAPH NOT FINAL part333 CVS Pharmacy ALCOHOL 65 mL/100mL 59779-101_1b824bd2-f314-405d-bd0a-3c5c52cde29d 59779-101 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen TABLET ORAL 19930121 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN 500 mg/1 59779-102_ed7b2cd3-a25d-444a-a9df-41b52e12b161 59779-102 HUMAN OTC DRUG Infants Relief Non-Staining Formula Dimethicone 410 LIQUID ORAL 20120203 OTC MONOGRAPH FINAL part332 CVS DIMETHICONE 410 20 mg/.3mL 59779-103_6015335e-9d6e-4f22-af49-5c299ae4ed5a 59779-103 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20090707 OTC MONOGRAPH FINAL part341 CVS ACETAMINOPHEN 160 mg/5mL 59779-104_861c49de-0857-4b2f-943a-baf13656a9db 59779-104 HUMAN OTC DRUG Regular Strength Pain Relief Acetaminophen TABLET ORAL 19900713 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN 325 mg/1 59779-105_2f75441b-0252-4f98-a313-4a36307ba34b 59779-105 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 19960116 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL 59779-106_8f3d3891-d894-4808-86c8-b4a08bcf2ddc 59779-106 HUMAN OTC DRUG CVS Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 5 mg/5mL 59779-107_54539040-666c-4f6c-bfd2-1201b55f495c 59779-107 HUMAN OTC DRUG CVS Gentle Laxative Bisacodyl Suppository SUPPOSITORY RECTAL 20140918 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy BISACODYL 10 mg/2000mg 59779-107_7a9c1891-97db-46a4-b720-dbd26f031ed0 59779-107 HUMAN OTC DRUG CVS Gentle Laxative Bisacodyl Suppository SUPPOSITORY RECTAL 20140918 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy BISACODYL 10 mg/2000mg 59779-108_fa96b38a-aae5-4d87-a55b-df334f1bf722 59779-108 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20140731 ANDA ANDA078682 CVS Pharmacy IBUPROFEN 200 mg/1 59779-109_c64569c2-3c60-48e7-9cf3-118a6c7e7d39 59779-109 HUMAN OTC DRUG CVS Pharmacy Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20140918 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy GLYCERIN 83 g/100g 59779-109_ed48d215-946e-42db-b268-c160e7bcdbdc 59779-109 HUMAN OTC DRUG CVS Pharmacy Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20140918 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy GLYCERIN 83 g/100g 59779-109_f27ceb05-72ef-423e-8035-6e53a8aa64f9 59779-109 HUMAN OTC DRUG CVS Pharmacy Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20140918 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy GLYCERIN 83 g/100g 59779-110_458114da-3557-4872-8b06-df7b0dc213b1 59779-110 HUMAN OTC DRUG disposable Povidone-iodine KIT 20091124 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy 59779-111_08a9b6de-4d9d-4d08-8527-6e6105c27daf 59779-111 HUMAN OTC DRUG Oral Saline Laxative Ginger Lemon dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20120831 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 2.7; 7.2 g/15mL; g/15mL 59779-112_9bb6eb81-1c3c-4e25-993b-92e6e31cb4a9 59779-112 HUMAN OTC DRUG Non-Drowsy Nasal Decongestant Pseudoephedrine HCl TABLET ORAL 19810825 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 59779-113_7b9a97be-bde5-497f-9933-0fbaf4be3559 59779-113 HUMAN OTC DRUG CVS PHARMACY JUICY PEAR BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140120 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL 59779-114_548e8cdf-28a5-4474-8439-b300e15c2e4f 59779-114 HUMAN OTC DRUG CVS PHARMACY FRESH WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL 59779-114_e7853a15-8990-459a-8d00-3f9b4a9177a7 59779-114 HUMAN OTC DRUG CVS PHARMACY FRESH WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL 59779-115_4c041c55-821c-426d-b834-637d966ed15e 59779-115 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part358F CVS Pharmacy SALICYLIC ACID 40 mg/91 59779-116_c73c1328-6ca1-467f-b76a-75653f95f8ed 59779-116 HUMAN OTC DRUG Salicylic acid Medicated Callus Removers Extra Thick PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part358F CVS Pharmacy SALICYLIC ACID 40 mg/41 59779-117_57a6227b-ce5b-47a6-9f01-c4bd1489488a 59779-117 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 CVS Pharmacy LANSOPRAZOLE 15 mg/1 59779-118_56479709-fd60-4c47-8fdc-53a18376b517 59779-118 HUMAN OTC DRUG CVS Therapeutic Menthol Gel Menthol GEL TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy MENTHOL 2 g/100g 59779-119_9dff36a0-4f83-433e-8b8b-6b8442845b85 59779-119 HUMAN OTC DRUG Salicylic acid One Step Wart Remover Strips PLASTER TOPICAL 20140104 OTC MONOGRAPH FINAL part358B CVS Pharmacy SALICYLIC ACID .4 g/1411 59779-120_84aadc71-65b1-40d4-83f7-0c5d5c936822 59779-120 HUMAN OTC DRUG C Lax Laxative Bisacodyl TABLET, COATED ORAL 20131230 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy BISACODYL 5 mg/1 59779-121_a7ed284f-1ce8-4769-9700-b7f5cf8c7b9e 59779-121 HUMAN OTC DRUG CVS Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 59779-122_e5b3f159-921b-4633-a15e-64d26cf83c94 59779-122 HUMAN OTC DRUG CVS Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 59779-123_88f06fd2-73c3-443f-9e22-26c7c8aef2a8 59779-123 HUMAN OTC DRUG CVS Maximum Strength Benzocaine PASTE, DENTIFRICE TOPICAL 20110120 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 20 g/100g 59779-124_2ca7d9ee-d9eb-4778-af16-7d9a9cc0124c 59779-124 HUMAN OTC DRUG nicotine Nicotine polacrilex LOZENGE ORAL 20091001 ANDA ANDA090711 CVS Pharmacy NICOTINE 2 mg/1 59779-125_77726185-c942-4376-b138-4df244c7889a 59779-125 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20140515 OTC MONOGRAPH FINAL part332 CVS Pharmacy DIMETHICONE 180 mg/1 59779-126_832acd72-1dda-4490-978f-5f31748942df 59779-126 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20140124 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL 59779-127_cb8a1d60-9a7a-4b7d-8114-9af891f92dd9 59779-127 HUMAN OTC DRUG Colloidal oatmeal Eczema Relief Continuous Spray AEROSOL, SPRAY TOPICAL 20141003 OTC MONOGRAPH FINAL part347 CVS Pharmacy OATMEAL 1.13 g/113g 59779-128_bd8c75e5-1723-4db4-8111-09e9b47dcc4c 59779-128 HUMAN OTC DRUG CVS Enamel Guard Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy POTASSIUM NITRATE; SODIUM FLUORIDE 5; 1.5 g/g; g/g 59779-129_45f56b56-8483-4d83-8cef-8234947b68a4 59779-129 HUMAN OTC DRUG CVS Pharmacy Premium Wash DIMETHICONE CLOTH TOPICAL 20110418 OTC MONOGRAPH FINAL part347 CVS Pharmacy DIMETHICONE 3 g/100g 59779-130_fcf63468-b494-41a5-ad4f-af59b647c1af 59779-130 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 19910615 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL 59779-131_d5503749-81c6-479d-9f2f-b607b20021b7 59779-131 HUMAN OTC DRUG CVS Pharmacy Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20091204 ANDA ANDA079205 CVS Pharmacy IBUPROFEN 200 mg/1 59779-132_003de20a-3ba2-442a-a56f-c79b9f723b9e 59779-132 HUMAN OTC DRUG UNDECYLENIC ACID UNDECYLENIC ACID LIQUID TOPICAL 20080601 OTC MONOGRAPH FINAL part333C CVS Pharmacy UNDECYLENIC ACID 288 mg/mL 59779-133_3362b2fd-fc18-463a-b6c2-a8c6ea5ef85b 59779-133 HUMAN OTC DRUG flu and sore throat soothing warm relief acetaminophen,pheniramine maleate, phenylephrine hydrochloride POWDER, FOR SUSPENSION ORAL 20100707 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/15000mg; mg/15000mg; mg/15000mg 59779-134_c8c09820-db77-4c18-9aa5-dfbf1c2fd7ae 59779-134 HUMAN OTC DRUG Stool Softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE CALCIUM 240 mg/1 59779-135_c6d91452-bccf-469e-9289-696b0fb4cedf 59779-135 HUMAN OTC DRUG CVS PSORIASIS MEDICATED Salicylic Acid LIQUID TOPICAL 20140901 OTC MONOGRAPH FINAL part358H CVS Pharmacy SALICYLIC ACID 3 g/100mL 59779-136_865a26e7-12a5-4196-8246-d966103afb64 59779-136 HUMAN OTC DRUG Salicylic Acid Wart Remover Medicated Discs PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part358B CVS Pharmacy SALICYLIC ACID 40 mg/181 59779-137_907609ed-048e-416a-bdcd-14d17d38e3f9 59779-137 HUMAN OTC DRUG Aspirin Safety Coated Aspirin TABLET, COATED ORAL 20140630 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 325 mg/1 59779-138_a3af3fbf-043d-4b11-8090-19e45a424f42 59779-138 HUMAN OTC DRUG Salicylic Acid Medicated Plantar Wart Remover PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part358B CVS Pharmacy SALICYLIC ACID 40 mg/241 59779-139_7d160649-aeaa-400b-8a5e-49ea2f9975a3 59779-139 HUMAN OTC DRUG Salicylic Acid Corn and Callus Remover Kit LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part358F CVS Pharmacy SALICYLIC ACID .17 mg/151mL 59779-140_c99c21a3-6002-46b6-a220-11226afc9053 59779-140 HUMAN OTC DRUG Night Time Cherry Pseudo-Free Doxylamine Succinate, Acetaminophen, Dextromethorphan Hydrobromide LIQUID ORAL 20090914 OTC MONOGRAPH FINAL part341 CVS ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 59779-141_c7cb4e19-3442-45d2-b60a-87d4beea862a 59779-141 HUMAN OTC DRUG acid controller original strength Famotidine TABLET ORAL 20091017 ANDA ANDA075400 CVS Pharmacy FAMOTIDINE 10 mg/1 59779-142_7525e273-51ea-4676-bcb8-1a32e66c3f42 59779-142 HUMAN OTC DRUG CVS Simple Care Protective Rash Dimethicone SPRAY TOPICAL 20140601 OTC MONOGRAPH FINAL part347 CVS Pharmacy DIMETHICONE 1 g/100mL 59779-143_a89f2f86-39e0-47b9-b4cf-6bd778512d2c 59779-143 HUMAN OTC DRUG Extra Strength Back and Body Aspirin, Caffeine TABLET, COATED ORAL 20040412 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ASPIRIN; CAFFEINE 500; 32.5 mg/1; mg/1 59779-144_8366cc78-8ca6-432e-89a6-d55bda5bb98c 59779-144 HUMAN OTC DRUG Childrens Plus Flu with PE ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE SUSPENSION ORAL 20090914 OTC MONOGRAPH FINAL part341 CVS ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 59779-145_cfd5a9ee-56b8-4ef6-a34e-03e0fa14ec77 59779-145 HUMAN OTC DRUG Tussin DM Maximum Strength Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20140531 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/10mL; mg/10mL 59779-146_505850fa-431c-44aa-a867-f708f203d034 59779-146 HUMAN OTC DRUG Childrens Plus Cold Grape ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE SUSPENSION ORAL 20090813 OTC MONOGRAPH FINAL part341 CVS ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 2.5 mg/5mL; mg/5mL; mg/5mL 59779-147_c008cd4d-4046-4710-9f70-f1633f3e3a9d 59779-147 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM 100 mg/1 59779-148_42c804c8-dcab-4f72-8b93-be5728602a18 59779-148 HUMAN OTC DRUG PETROLATUM PETROLATUM OINTMENT TOPICAL 20090519 OTC MONOGRAPH FINAL part347 CVS PETROLATUM 600 mg/g 59779-149_3d2076eb-b5b6-4695-bf5d-b08f3b6afb63 59779-149 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20120830 OTC MONOGRAPH FINAL part333B CVS Pharmacy BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 59779-150_7fbf0241-3719-4890-b7e1-fbf3ad297906 59779-150 HUMAN OTC DRUG CVS Moisturizing Lubricating Eye Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20130903 OTC MONOGRAPH FINAL part349 CVS Pharmacy CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/100mg; mg/100mg 59779-151_c5122649-b40b-4876-8eed-7ba624765226 59779-151 HUMAN OTC DRUG CVS Long Lasting Lubricant Eye Polyethylene Glycol 400 SOLUTION/ DROPS OPHTHALMIC 20130917 OTC MONOGRAPH FINAL part349 CVS Pharmacy, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mg/mg; mg/mg 59779-152_77a2498b-ef4b-49a6-a5bf-0fed8e9b3a0d 59779-152 HUMAN OTC DRUG CVS PHARMACY CLEAR SKIN DAILY MOISTURIZER SALICYLIC ACID LIQUID TOPICAL 20141130 OTC MONOGRAPH FINAL part333D CVS PHARMACY SALICYLIC ACID 5 mg/mL 59779-153_2d2214e1-4883-490a-8c00-422ad2057de9 59779-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc PYRITHIONE ZINC 10 mg/mL 59779-154_68829cc4-c08f-4c24-a37b-7735bca8ef58 59779-154 HUMAN OTC DRUG Flu Relief Therapy Night Time Theraflu Nighttime LIQUID ORAL 20090101 OTC MONOGRAPH FINAL part341 CVS ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL 59779-155_8bd22188-ae51-46d0-8d4e-15d6c083bf15 59779-155 HUMAN OTC DRUG Total Home Antibacterial Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE .115 g/1 59779-157_119b46d2-81b3-4454-af41-8bbc308fb4d8 59779-157 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20060210 OTC MONOGRAPH FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ASPIRIN 325 mg/1 59779-158_271614fe-617b-4152-82d2-902c76e7db59 59779-158 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20140430 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 59779-159_9a990f40-6622-4303-bb43-b3537e71ae61 59779-159 HUMAN OTC DRUG Cough Relief Grape Delsym Grape LIQUID ORAL 20090914 OTC MONOGRAPH FINAL part341 CVS DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 59779-160_98ffe67e-25a4-420b-94b9-0110ef0b1d97 59779-160 HUMAN OTC DRUG CVS Antibacterial Foaming Kitchen Triclosan SOAP TOPICAL 20101004 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy TRICLOSAN .46 mL/100mL 59779-161_87f2ec74-d507-4267-9a47-209d85b6e095 59779-161 HUMAN OTC DRUG infants pain and fever Acetaminophen LIQUID ORAL 20111013 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL 59779-162_46627cda-f42c-421d-a104-70b4be53b8e1 59779-162 HUMAN OTC DRUG Senna Plus docusate sodium and sennosides TABLET ORAL 20100726 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 59779-163_00d46594-cc41-49c8-96f7-321b8debb269 59779-163 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20080915 OTC MONOGRAPH FINAL part355 CVS Pharmacy, Inc SODIUM FLUORIDE .1 mg/mL 59779-164_cba0453a-58f3-4dfb-a00b-bbca751def42 59779-164 HUMAN OTC DRUG Regular Strength Aspirin Aspirin and Caffeine TABLET, FILM COATED ORAL 20110101 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ASPIRIN; CAFFEINE 400; 32 mg/1; mg/1 59779-165_13dae5c5-1963-4485-a240-c056a8c39ac9 59779-165 HUMAN OTC DRUG Miconazole Nitrate Anti-fungal Powder Miconazole Nitrate POWDER TOPICAL 20140101 OTC MONOGRAPH FINAL part333C CVS Pharmacy MICONAZOLE NITRATE 1.42 g/71g 59779-166_218c45e5-1c53-4e84-ae57-3b7ce86f43cb 59779-166 HUMAN OTC DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20020827 ANDA ANDA074937 CVS Pharmacy IBUPROFEN 100 mg/5mL 59779-168_e2208773-2d25-4a77-b5b0-753c61c6373d 59779-168 HUMAN OTC DRUG ANTIBACTERIAL FOAMING REFILL TRICLOSAN LIQUID TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .6 mL/100mL 59779-169_8e3a3825-f95f-4259-a1c4-8c61123d219f 59779-169 HUMAN OTC DRUG ANTIBACTERIAL FOAMING HAND SP CLEAN AND MILD TRICLOSAN LIQUID TOPICAL 20110203 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .6 mL/100mL 59779-170_376094cb-233f-4043-8683-9a95b6dce1a9 59779-170 HUMAN OTC DRUG nicotine polacrilex stop smoking aid Nicotine Polacrilex GUM, CHEWING ORAL 20050707 ANDA ANDA076789 CVS Pharmacy NICOTINE 4 mg/1 59779-171_1dbdb99a-344d-4613-9023-bea0a7043e10 59779-171 HUMAN OTC DRUG stool softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20131001 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE CALCIUM 240 mg/1 59779-172_e82a952d-1cc1-4036-8692-d4107ef0d7d3 59779-172 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140430 ANDA ANDA079096 CVS Pharmacy NAPROXEN SODIUM 220 mg/1 59779-173_6ddce52c-0535-4108-a40d-242dffd580f1 59779-173 HUMAN OTC DRUG lice kit Piperonyl Butoxide, Pyrethrum Extract KIT 20070915 OTC MONOGRAPH FINAL part358G CVS Pharmacy 59779-173_beaad131-f46c-462b-8c8c-aabd476d78dc 59779-173 HUMAN OTC DRUG lice kit piperonyl butoxide, pyrethrum extract KIT 20070915 OTC MONOGRAPH FINAL part358G CVS Pharmacy 59779-174_c5490974-f198-4114-85f8-5c5c594846c2 59779-174 HUMAN OTC DRUG Calamine Plus Pramoxine HCl Calamine Plus Spray AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE .345; 2.72; 24.16 mg/116g; mg/116g; mg/116g 59779-175_33420d42-4d2a-49e8-abf3-61c438e18455 59779-175 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 19931022 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL 59779-176_07253a71-461f-4746-8a3e-a9b6719b89b2 59779-176 HUMAN OTC DRUG Allergy Relief D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080410 ANDA ANDA077170 CVS Pharmacy CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 59779-177_23934d52-72d7-4f51-aa3c-55142631b245 59779-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110706 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .46 mL/100mL 59779-178_ab918faa-824b-4e49-97de-7230e59afa6e 59779-178 HUMAN OTC DRUG Undecylenic Acid Liquid Anti-Fungal Liquid Maximum Strength LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part333C CVS Pharmacy UNDECYLENIC ACID 7.5 g/30g 59779-179_0153ca1e-5be7-4ddf-8993-44fb3c9bb65b 59779-179 HUMAN OTC DRUG CVS PHARMACY CLEAN ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120705 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .46 mg/100mL 59779-179_80c68bd4-1d49-431b-a814-16098e9448b3 59779-179 HUMAN OTC DRUG CVS PHARMACY CLEAN ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .46 mg/100mL 59779-180_3a667c4c-b67a-4db7-a5dc-0a6199b435c7 59779-180 HUMAN OTC DRUG ibuprofen cold relief childrens Ibuprofen, Pseudoephedrine HCl SUSPENSION ORAL 20040212 ANDA ANDA076478 CVS Pharmacy IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100; 15 mg/5mL; mg/5mL 59779-181_a251d372-901d-4b85-9bd4-96de0803fd3b 59779-181 HUMAN OTC DRUG purelax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20100302 ANDA ANDA090685 CVS Pharmacy POLYETHYLENE GLYCOL 3350 17 g/17g 59779-182_89e6b00f-8158-40cd-927d-31708401bf43 59779-182 HUMAN OTC DRUG Senna laxative Natural vegetable laxative SENNOSIDES TABLET ORAL 20100729 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy SENNOSIDES 8.6 mg/1 59779-183_7b22a31c-e50b-4c5f-865b-9bc9341c9c10 59779-183 HUMAN OTC DRUG Regular Strength Buffered Aspirin Aspirin TABLET, FILM COATED ORAL 19900330 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ASPIRIN 325 mg/1 59779-185_e7ef0cc9-d140-4374-b54f-ff2fa8a909d8 59779-185 HUMAN OTC DRUG Salicylic Acid Wart Remover Gel Pen GEL TOPICAL 20141001 OTC MONOGRAPH FINAL part358B CVS Pharmacy SALICYLIC ACID .21 g/1.25g 59779-186_34480b2a-2095-4581-874c-d8fd71c4f47e 59779-186 HUMAN OTC DRUG CVS Oral Anesthetic BENZOCAINE LIQUID ORAL 20100708 OTC MONOGRAPH FINAL part356 CVS Pharmacy BENZOCAINE 200 mg/mL 59779-187_618e18ea-74c1-49c8-abf1-f09d5fe55784 59779-187 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET, COATED ORAL 19941207 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 59779-188_a9f154d3-621f-4f6a-bdba-c5bf10f42d22 59779-188 HUMAN OTC DRUG CVS PHARMACY PEAR WHITE TEA TRICLOSAN LIQUID TOPICAL 20120130 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .46 mL/100mL 59779-188_c88db58a-5011-46e4-930f-40db16cc6d4c 59779-188 HUMAN OTC DRUG CVS PHARMACY PEAR WHITE TEA TRICLOSAN LIQUID TOPICAL 20120130 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .46 mL/100mL 59779-189_c1f95d5d-50d4-47f2-b426-2028cd55ea16 59779-189 HUMAN OTC DRUG CVS PHARMACY MANDARIN CITRUS TRICLOSAN LIQUID TOPICAL 20120127 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .46 mL/100mL 59779-190_afa9b2aa-eb32-4a4f-9537-3060c57982b6 59779-190 HUMAN OTC DRUG nicotine Nicotine polacrilex LOZENGE ORAL 20091001 ANDA ANDA090711 CVS Pharmacy NICOTINE 4 mg/1 59779-191_ed2837f3-6cff-43ea-a007-ab7a07ebfaf7 59779-191 HUMAN OTC DRUG KIDS PAIN RELIEF WITH ARNICA ARNICA MONTANA, HYPERICUM PERFORATUM CREAM TOPICAL 20121207 UNAPPROVED HOMEOPATHIC CVS PHARMACY ARNICA MONTANA; HYPERICUM PERFORATUM 1; 1 [hp_X]/50g; [hp_X]/50g 59779-192_54fe52c7-6f62-43ca-a65c-86e8148c3f16 59779-192 HUMAN OTC DRUG KIDS FIRST AID WITH CALENDULA CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, HYPERICUM PERFORATUM, PHYTOLACCA DECANDRA, CANTHARIS, SULPHUR CREAM TOPICAL 20121207 UNAPPROVED HOMEOPATHIC CVS PHARMACY CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; LYTTA VESICATORIA; PHYTOLACCA AMERICANA ROOT; SULFUR 1; 1; 3; 3; 3; 3 [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g 59779-193_def46ccd-27e5-4f76-a950-6f275071b633 59779-193 HUMAN OTC DRUG CVS Pharmacy Brilliant White Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy SODIUM FLUORIDE .243 g/100g 59779-194_1531aa51-02e9-45ed-99aa-53b21732dd2e 59779-194 HUMAN OTC DRUG acid controller Famotidine TABLET ORAL 20060928 ANDA ANDA077351 CVS Pharmacy FAMOTIDINE 20 mg/1 59779-196_52e2f30a-bdbc-437f-acac-cae0cef6f3f9 59779-196 HUMAN OTC DRUG cough and sore throat childrens Acetaminophen, Dextromethorphan HBr SUSPENSION ORAL 20090715 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 5 mg/5mL; mg/5mL 59779-197_2ecfcd0b-c27c-4ee2-bd72-31bdd4c42e14 59779-197 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120924 ANDA ANDA078682 CVS Pharmacy IBUPROFEN 200 mg/1 59779-198_587f208f-cd81-430b-af5e-1ef56c1a8459 59779-198 HUMAN OTC DRUG Motion Sickness Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DIMENHYDRINATE 50 mg/1 59779-199_15aba636-cc89-41a0-b498-c13dc0f97ffa 59779-199 HUMAN OTC DRUG miconazole 1 yeast infection relief Miconazole nitrate KIT 20100608 ANDA ANDA079114 CVS Pharmacy 59779-200_2a0a8b20-2894-4ee2-ab9a-95004e0796af 59779-200 HUMAN OTC DRUG CVS Pharmacy Instant Hand Sanitizer With Aloe And Vitamin E ALCOHOL GEL TOPICAL 20091210 OTC MONOGRAPH NOT FINAL part333 CVS Pharmacy ALCOHOL 65 mL/100mL 59779-201_ab1407e3-9092-438c-b684-8194e4ee71af 59779-201 HUMAN OTC DRUG nicotine Nicotine Polacrilex LOZENGE ORAL 20100512 ANDA ANDA090821 CVS Pharmacy NICOTINE 2 mg/1 59779-202_4334094b-7158-416a-8d8a-d315c5b16671 59779-202 HUMAN OTC DRUG hair regrowth treatment for women minoxidil SOLUTION TOPICAL 19900415 ANDA ANDA075357 CVS Pharmacy MINOXIDIL 2 g/100mL 59779-203_19ecb660-134e-4f89-8a3b-f64417c24673 59779-203 HUMAN OTC DRUG CVS pharmacy Clinical Strength Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20111024 OTC MONOGRAPH FINAL part350 CVS pharmacy ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g 59779-204_73773dd0-d184-4b5d-8798-c5ba6c7d762e 59779-204 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 CVS Pharmacy PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 59779-205_3ded2ae2-c835-4e81-9c92-9b6849d4a8a9 59779-205 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE ORAL 20100716 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM 100 mg/1 59779-206_90adcd55-2d49-4f65-899c-8b5efe2e261b 59779-206 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050708 ANDA ANDA078325 CVS Pharmacy NICOTINE 2 mg/1 59779-207_346e5ace-874f-4dfe-bd6a-3b1b40c00d7b 59779-207 HUMAN OTC DRUG Wintergreen Isopropyl Alcohol Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20090403 OTC MONOGRAPH FINAL part333 CVS ISOPROPYL ALCOHOL 70 mL/100mL 59779-208_98c887dd-8471-4af7-b83f-714a1c018287 59779-208 HUMAN OTC DRUG EARACHE KIDS RELIEF FERRUM PHOSPHORICUM, CAPSICUM ANNUUM, PYROGENIUM, ARSENICUM ALBUM, BELLADONNA LIQUID ORAL 20121207 UNAPPROVED HOMEOPATHIC CVS PHARMACY ARSENIC TRIOXIDE; ATROPA BELLADONNA; FERRUM PHOSPHORICUM; RANCID BEEF; RED PEPPER 30; 30; 30; 30; 30 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL 59779-209_d6cd514c-150e-40bb-a558-b569fd6cfadd 59779-209 HUMAN OTC DRUG TEETHING CHAMOMILLA, ARNICA MONTANA, BORAX, HYPERICUM PERFORATUM TABLET, CHEWABLE ORAL 20130501 UNAPPROVED HOMEOPATHIC CVS PHARMACY ARNICA MONTANA; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; SODIUM BORATE 5; 5; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 59779-210_181a4539-7f36-47b6-a14d-e512dbd98f31 59779-210 HUMAN OTC DRUG CVS Pharmacy Instant Hand Sanitizer With Aloe And Vitamin E ALCOHOL GEL TOPICAL 20100129 OTC MONOGRAPH NOT FINAL part333 CVS Pharmacy ALCOHOL 65 mL/100mL 59779-211_df6f29c2-3133-462d-8b1c-91dc514fdd8c 59779-211 HUMAN OTC DRUG CVS PHARMACY ANTIBACTERIAL TRICLOSAN SOAP TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .15 mL/100mL 59779-212_4ce0319e-1067-4a3b-b1fe-7a5e22e64f47 59779-212 HUMAN OTC DRUG Antacid Liquid Max Strength Cherry ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE SUSPENSION ORAL 20090210 OTC MONOGRAPH FINAL part331 CVS ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 59779-213_a73a476e-8faf-4a7f-b670-855383d53c68 59779-213 HUMAN OTC DRUG Anticavity Fluoride Sodium Fluoride RINSE ORAL 20010619 OTC MONOGRAPH FINAL part355 CVS Pharmacy, Inc SODIUM FLUORIDE .05 kg/100L 59779-214_4a29fc0c-692e-48dc-8378-9242e518af6b 59779-214 HUMAN OTC DRUG miconazole 7 Miconazole nitrate CREAM VAGINAL 19990902 ANDA ANDA074760 CVS Pharmacy MICONAZOLE NITRATE 2 g/100g 59779-215_df976eb1-94dd-4285-820b-e7a4e0c25013 59779-215 HUMAN OTC DRUG daytime non drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20081029 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 59779-216_53769624-5c8d-44ef-9671-3c4d9fea5a77 59779-216 HUMAN OTC DRUG Antibacterial Hand Triclosan SOAP TOPICAL 20100706 OTC MONOGRAPH NOT FINAL part333 CVS Pharmacy TRICLOSAN .15 mL/100mL 59779-216_d9a07d4a-43a3-4e42-a548-2df3c1de4dc2 59779-216 HUMAN OTC DRUG Antibacterial Hand Triclosan SOAP TOPICAL 20100706 OTC MONOGRAPH NOT FINAL part333 CVS Pharmacy TRICLOSAN .15 mL/100mL 59779-217_9bdff4b6-57af-4cf2-aa4c-3e35bf3dd202 59779-217 HUMAN OTC DRUG 8 hour pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080827 ANDA ANDA075077 CVS Pharmacy ACETAMINOPHEN 650 mg/1 59779-218_0a070976-53e9-4463-8257-8647f1f320bb 59779-218 HUMAN OTC DRUG Chewable Aspirin Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ASPIRIN 81 mg/1 59779-219_26b478b1-024e-4683-80d4-a268fed0ce63 59779-219 HUMAN OTC DRUG Redness Relief Original Naphazoline Hydrochloride and Polyethylene glycol 300 SOLUTION/ DROPS OPHTHALMIC 20100913 20170228 OTC MONOGRAPH FINAL part349 CVS Pharmacy NAPHAZOLINE HYDROCHLORIDE; POLYETHYLENE GLYCOL 300 .1; 2 mg/mL; mg/mL 59779-220_0dbd9bc2-c27f-4ed8-99e6-b98798ed0a8f 59779-220 HUMAN OTC DRUG CVS Pharmacy Daytime Severe Cough and Cold Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20130401 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 59779-221_c73f9aba-85ae-4825-9fd4-572d4f28bc89 59779-221 HUMAN OTC DRUG CVS Pharmacy Nighttime Severe Cough and Cold honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20130325 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 59779-222_6091416e-3d90-4183-833d-1b80d296e87e 59779-222 HUMAN OTC DRUG Antacid Antigas Maximum Strength Mint ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part331 CVS ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 59779-223_d9cab0d1-57f4-4e66-aab6-1b3b4aa8df1e 59779-223 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH ALOE ETHYL ALCOHOL GEL TOPICAL 20110318 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 62 mL/100mL 59779-224_a79ca6dd-0028-44c9-bcef-b13cab3b64a0 59779-224 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH SHEA BUTTER ETHYL ALCOHOL GEL TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 62 mL/100mL 59779-224_c99204a5-ceb2-4e2a-88b2-1de8cf3fe5a6 59779-224 HUMAN OTC DRUG Instant Hand Sanitizer With Shea Butter Ethyl Alcohol GEL TOPICAL 20100726 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy ALCOHOL 62 mL/100mL 59779-224_f243e3e9-ccb3-411d-890f-813fb21320ee 59779-224 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH SHEA BUTTER ETHYL ALCOHOL GEL TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 62 mL/100mL 59779-226_5529cc80-bc5e-4d2b-a0ec-7291c0a0df54 59779-226 HUMAN OTC DRUG Caffeine Caffeine TABLET ORAL 19921121 OTC MONOGRAPH FINAL part340 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED CAFFEINE 200 mg/1 59779-227_f36df286-f0e2-4d25-9682-aa093d28134f 59779-227 HUMAN OTC DRUG Aspirin Enteric Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ASPIRIN 325 mg/1 59779-228_067495f0-9eed-4860-a506-dc21ea139bc7 59779-228 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20120919 OTC MONOGRAPH FINAL part338 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 59779-229_af7f1080-32ce-4a27-acf8-0dd622bec24c 59779-229 HUMAN OTC DRUG poly bacitracin Bacitracin, Polymyxin B OINTMENT TOPICAL 20050608 OTC MONOGRAPH FINAL part333B CVS Pharmacy BACITRACIN; POLYMYXIN B 500; 10000 [USP'U]/g; [USP'U]/g 59779-231_aa9a7cd2-3e6e-421b-b79f-827a17bfb0bc 59779-231 HUMAN OTC DRUG CVS Athletes Foot Cream .5oz Tolnaftate CREAM TOPICAL 20141013 OTC MONOGRAPH FINAL part333C CVS Pharmacy, Inc. TOLNAFTATE 10 mg/g 59779-232_4c178cb1-7545-46ce-bf22-c465f4e98e58 59779-232 HUMAN OTC DRUG CVS Phramacy Antibacterial Melon Triclosan SOAP TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy TRICLOSAN .115 mL/100mL 59779-235_0ed230c7-0987-49bf-b123-f66ef2484dae 59779-235 HUMAN OTC DRUG Extra Strength Pain Relief PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 59779-236_702b3852-c504-4f72-aa66-d9c1dd14974f 59779-236 HUMAN OTC DRUG Nighttime Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 59779-238_69ebd922-0cca-48bd-bfe3-2b140d7d3712 59779-238 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19950829 OTC MONOGRAPH FINAL part334 CVS Pharmacy, Inc MAGNESIUM CITRATE 1.745 g/29.6mL 59779-241_0445bb09-e6a9-4669-bc6e-308eed980df0 59779-241 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100716 OTC MONOGRAPH FINAL part347 CVS Pharmacy DIMETHICONE 125 mg/1 59779-242_3dcb6ffa-a61c-45aa-9569-79ff9fcbb7f2 59779-242 HUMAN OTC DRUG Childrens Plus Cough and Runny Nose ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE SUSPENSION ORAL 20090914 OTC MONOGRAPH FINAL part341 CVS ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL 59779-244_04764684-301b-40f9-a5ed-ef413685d780 59779-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131015 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM 100 mg/1 59779-245_5e67f1e0-eb94-4a3d-999c-07efb2329578 59779-245 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy SENNOSIDES 25 mg/1 59779-246_e3c31023-06eb-4cba-9b74-0fac6b3a394f 59779-246 HUMAN OTC DRUG Childrens Plus Cold Grape ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE SUSPENSION ORAL 20090827 OTC MONOGRAPH FINAL part341 CVS ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 2.5 mg/5mL; mg/5mL; mg/5mL 59779-247_7350bd03-d7d0-4044-add9-64744a420bd8 59779-247 HUMAN OTC DRUG CVS Medicated Pads WITCH HAZEL SWAB TOPICAL 20111113 OTC MONOGRAPH FINAL part346 CVS PHARMACY WITCH HAZEL 1 g/1 59779-248_4ce135fa-5afd-4639-bb93-90b7e58859fe 59779-248 HUMAN OTC DRUG CVS Extra Strength Itch Relief DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE SPRAY TOPICAL 20110810 OTC MONOGRAPH FINAL part336 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/mL; mg/mL 59779-249_1cadaed1-3558-44bf-a190-73eede6267f0 59779-249 HUMAN OTC DRUG Uncoated Aspirin Aspirin TABLET ORAL 19930804 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ASPIRIN 325 mg/1 59779-250_664c5da7-0f64-4f93-b7cc-f81958dc40e0 59779-250 HUMAN OTC DRUG CVS Daily Acne Clearing Scrub SALICYLIC ACID SOAP TOPICAL 20111113 OTC MONOGRAPH FINAL part333D CVS Pharmacy SALICYLIC ACID 20 mg/mL 59779-251_5c3315ea-87be-4066-83ce-943d17f36d6b 59779-251 HUMAN OTC DRUG ANTI-AGING HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110318 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 62 mL/100mL 59779-252_13abf865-abaa-4e42-a301-39450946020e 59779-252 HUMAN OTC DRUG INSTANT FOAM HAND SANITIZER ALOE BENZALKONIUM CHLORIDE GEL TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE .1 mL/100mL 59779-253_1b6f78c3-2eee-409d-8068-4bf8ce4e9cd9 59779-253 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20110124 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 65 mL/100mL 59779-253_6755eb01-4c0e-4ce2-880e-e82392e939d8 59779-253 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20110124 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 65 mL/100mL 59779-254_87648b12-99a8-4ef6-bc29-d9beb014a85c 59779-254 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110623 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 65 mL/100mL 59779-254_a53d8ffe-ad8f-4f34-bd9d-de10f6382d03 59779-254 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110623 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 65 mL/100mL 59779-254_c8390466-507b-4338-a810-e572dfe05ea1 59779-254 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 65 mL/100mL 59779-254_fd11cf87-d8fd-4af6-b054-afad61272725 59779-254 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110623 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 65 mL/100mL 59779-255_c6e6e4ca-5c8f-494f-9499-e791571b82de 59779-255 HUMAN OTC DRUG BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE LIQUID TOPICAL 20100708 OTC MONOGRAPH FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 26; 25 mg/mL; mg/mL 59779-256_c052e919-8825-4e92-b698-d3e745b61038 59779-256 HUMAN OTC DRUG CVS Antiseptic Wash BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE LIQUID TOPICAL 20100708 OTC MONOGRAPH FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 20 mg/mL; mg/mL 59779-257_7334f45e-5f8f-4072-93e7-2f907db8d2d5 59779-257 HUMAN OTC DRUG CVS Earwax Removal Aid CARBAMIDE PEROXIDE LIQUID TOPICAL 20110425 OTC MONOGRAPH FINAL part344 CVS Pharmacy CARBAMIDE PEROXIDE 65 mg/mL 59779-258_8f767897-e9c3-4078-9509-8ee5e0bc3ccf 59779-258 HUMAN OTC DRUG Antibacterial Hand Sanitizer Citrus Coconut Alcohol GEL TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy Inc ALCOHOL 62 mL/100mL 59779-258_c7156fa1-7a30-4a30-b832-93dd6c9cf6f9 59779-258 HUMAN OTC DRUG Antibacterial Hand Sanitizer Citrus Coconut Alcohol GEL TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy Inc ALCOHOL 62 mL/100mL 59779-259_0bdc89f7-4080-4329-a4dc-4d42458da5a6 59779-259 HUMAN OTC DRUG Antibacterial Hand Sanitizer Passion Flower Alcohol GEL TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy Inc ALCOHOL 62 mL/100mL 59779-259_c1ab44de-0487-4d69-9c95-5f040f003181 59779-259 HUMAN OTC DRUG Antibacterial Hand Sanitizer Passion Flower Alcohol GEL TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy Inc ALCOHOL 62 mL/100mL 59779-260_7fc9afb2-ea16-42b5-acb5-ba9f22790088 59779-260 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20090707 OTC MONOGRAPH NOT FINAL part334 CVS MINERAL OIL 15 mL/15mL 59779-261_66244b08-bfc2-4e8c-b0c3-8c4dd9d6f262 59779-261 HUMAN OTC DRUG Antibacterial Hand Sanitizer Sunblossom Alcohol GEL TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy Inc ALCOHOL 62 mL/100mL 59779-261_b01940dc-a0a4-4ff2-8803-58bebb68cf3e 59779-261 HUMAN OTC DRUG Antibacterial Hand Sanitizer Sunblossom Alcohol GEL TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy Inc ALCOHOL 62 mL/100mL 59779-262_099b31b6-7b68-45f4-850a-69980998508e 59779-262 HUMAN OTC DRUG Antibacterial Hand Sanitizer Pamegranate Apple Alcohol GEL TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy Inc ALCOHOL 62 mL/100mL 59779-262_2fd52006-947d-4ab9-bb4b-58ee7c4412a6 59779-262 HUMAN OTC DRUG Antibacterial Hand Sanitizer Pamegranate Apple Alcohol GEL TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy Inc ALCOHOL 62 mL/100mL 59779-263_caa9d16b-c4c5-4b87-a734-bd6091c89949 59779-263 HUMAN OTC DRUG childrens pain and fever Acetaminophen SUSPENSION ORAL 19910615 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL 59779-264_f01fe206-9289-48a2-935a-4051292a25d5 59779-264 HUMAN OTC DRUG CVS Revitalift Complete with SPF-15 ENSULIZOLE AND OCTINOXATE LOTION TOPICAL 20100719 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy ENSULIZOLE; OCTINOXATE 17; 75 mg/g; mg/g 59779-265_a4d0d0be-1cb7-47a2-a6aa-75d93dea7545 59779-265 HUMAN OTC DRUG CVS HEMORRHOIDAL COOLING WITCH HAZEL, PHENYLEPHRINE HYDROCHLORIDE GEL TOPICAL 20101118 OTC MONOGRAPH FINAL part346 CVS Pharmacy PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL 2.5; 500 mg/g; mg/g 59779-267_43b58db2-ba99-416d-a288-6c959795ae8e 59779-267 HUMAN OTC DRUG CVS PHARMACY WITH VITAMIN E ETHYL ALCOHOL LIQUID TOPICAL 20131002 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL 59779-272_582e4be6-2c23-486f-a035-cd20e52b9f1d 59779-272 HUMAN OTC DRUG CVS WHITE TEA BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140422 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL 59779-273_2f6fa26f-81ea-490c-94d7-f5d08767db4f 59779-273 HUMAN OTC DRUG CVS WHITE TEA BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140422 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL 59779-274_734b27dc-26b6-4447-bf21-05aa07c01317 59779-274 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 19970220 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 81 mg/1 59779-276_2a3826ee-9df2-4902-a537-9152dada2da7 59779-276 HUMAN OTC DRUG CVS Pharmacy Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 5 mg/5mL 59779-277_810218de-875d-4230-9668-ae72a4cc19e7 59779-277 HUMAN OTC DRUG CVS HYDROCORTISONE WITH ALOE HYDROCORTISONE CREAM TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part348 CVS PHARMACY HYDROCORTISONE .5 g/100g 59779-279_e8a8431b-7851-4da0-a4fa-e242cf3daf2e 59779-279 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140911 OTC MONOGRAPH FINAL part346 CVS Pharmacy COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 59779-280_aed0fa5e-7b6c-4dd8-b80a-ad87998b4df7 59779-280 HUMAN OTC DRUG Miconazole Nitrate Athlete s Foot Spray AEROSOL, POWDER TOPICAL 20140101 OTC MONOGRAPH FINAL part333C CVS Pharmacy MICONAZOLE NITRATE 2.6 g/130g 59779-281_6e325f31-71db-4a83-96c2-e3707522f8dd 59779-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20020315 OTC MONOGRAPH FINAL part358H CVS Pharmacy PYRITHIONE ZINC 1 kg/100L 59779-282_116c5d15-71ca-44d0-9457-b34cce02c64b 59779-282 HUMAN OTC DRUG Allergy Relief Clemastine fumarate TABLET ORAL 19960828 ANDA ANDA074512 CVS Pharmacy CLEMASTINE FUMARATE 1.34 mg/1 59779-284_7fcc142e-92c6-4b88-af2c-55052c72b53c 59779-284 HUMAN OTC DRUG Antibacterial SUNBLOSSOM Triclosan SOAP TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy TRICLOSAN .3 mL/100mL 59779-285_8a4c07fd-3733-4ca2-b5c3-30af9999a5f4 59779-285 HUMAN OTC DRUG Antibacterial Passion Flower Triclosan SOAP TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy TRICLOSAN .3 mL/100mL 59779-286_2897159d-bd19-4180-a67e-8269ed4a5afe 59779-286 HUMAN OTC DRUG Antibacterial Pamegranate Apple Triclosan SOAP TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy TRICLOSAN .3 mL/100mL 59779-287_241f7db9-afcf-4105-ba0c-662097661752 59779-287 HUMAN OTC DRUG Antibacterial Citrus Coconut Triclosan SOAP TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy TRICLOSAN .3 mL/100mL 59779-288_d450289e-b2c1-4dfb-8756-1ac6c310efaf 59779-288 HUMAN OTC DRUG chest congestion childrens Guaifenesin LIQUID ORAL 20090311 OTC MONOGRAPH FINAL part341 CVS Pharmacy GUAIFENESIN 100 mg/5mL 59779-289_46eb553e-29e7-4614-bce3-d148dfa34bf4 59779-289 HUMAN OTC DRUG Infants pain relief Concentrated Acetaminophen SUSPENSION/ DROPS ORAL 19931130 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 80 mg/.8mL 59779-291_8490971d-b4c8-47c2-b86d-9fd91a406fb4 59779-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED IBUPROFEN 200 mg/1 59779-292_d2ca410c-3dd1-4c12-a41b-65b824f54d08 59779-292 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 19880524 ANDA ANDA075010 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED IBUPROFEN 200 mg/1 59779-293_19303455-779f-41c6-9957-0e47144e77e4 59779-293 HUMAN OTC DRUG cold and cough nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20070728 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 59779-294_58374036-e6e2-42da-82dc-1e30a7b0a21a 59779-294 HUMAN OTC DRUG hair regrowth treatment for men Minoxidil AEROSOL, FOAM TOPICAL 20120302 ANDA ANDA091344 CVS Pharmacy MINOXIDIL 5 g/100g 59779-296_8efe4389-8961-4a23-8b3d-5380ee59d106 59779-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20090512 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc PYRITHIONE ZINC 10 mg/mL 59779-298_a12e841a-3546-4e2c-890e-fff3a817ca41 59779-298 HUMAN OTC DRUG Senna Laxative Sennosides TABLET ORAL 19950127 OTC MONOGRAPH NOT FINAL part334 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED SENNOSIDES 8.6 mg/1 59779-299_fc620f45-3627-4abb-8596-812f2c0124c3 59779-299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 20070501 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL 59779-300_b602f161-50d5-4f0e-a324-ef87e2d52dbb 59779-300 HUMAN OTC DRUG Tussin Cough Long Acting DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20090708 OTC MONOGRAPH FINAL part341 CVS DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL 59779-301_16c5d17c-4ff4-445a-9472-d236e3fdc648 59779-301 HUMAN OTC DRUG age renewal firming and hydrating moisturizer Octinoxate, Octisalate, Oxybenzone, Zinc Oxide CREAM TOPICAL 20091222 OTC MONOGRAPH FINAL part352 Woonsocket Prescription Center, Incorporated OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .075; .05; .04; .02 g/g; g/g; g/g; g/g 59779-302_43f74d32-479f-4307-a95b-e6b15d1c96b3 59779-302 HUMAN OTC DRUG Magnesium Citrate MAGNESIUM CITRATE LIQUID ORAL 20090707 OTC MONOGRAPH NOT FINAL part334 CVS MAGNESIUM CITRATE 2.65 mL/100mL 59779-303_90518a76-e318-4eae-92e8-3efda3d105ed 59779-303 HUMAN OTC DRUG Sodium Chloride Sodium Chloride OINTMENT OPHTHALMIC 20130221 OTC MONOGRAPH FINAL part349 CVS Pharmacy SODIUM CHLORIDE 50 mg/g 59779-304_e0798074-2139-4774-9214-9abb9a87102f 59779-304 HUMAN OTC DRUG nasal original oxymetazoline hydrochloride SPRAY NASAL 19910918 OTC MONOGRAPH FINAL part341 CVS Pharmacy OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 59779-305_f0144e47-b5d2-4bec-9a28-fb4f28e65b48 59779-305 HUMAN OTC DRUG Clotrimazole 1% Athletes Foot Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C CVS Pharmacy CLOTRIMAZOLE 10 mg/g 59779-306_4bde319a-1b92-4fad-8ddd-a10c350c716b 59779-306 HUMAN OTC DRUG purelax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 CVS Pharmacy POLYETHYLENE GLYCOL 3350 17 g/17g 59779-307_b01c720f-0d24-4a3b-8591-f005c0272d94 59779-307 HUMAN OTC DRUG CVS Pharmacy Anti-itch Hydrocortisone CREAM TOPICAL 20131013 OTC MONOGRAPH NOT FINAL part348 CVS HYDROCORTISONE 1 g/100g 59779-308_2273d3f2-8f3b-4f1a-a8ca-2f8899601ba4 59779-308 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20140228 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL 59779-310_e5a07737-d661-4535-8d4d-e3800d32f601 59779-310 HUMAN OTC DRUG Tussin Original GUAIFENESIN LIQUID ORAL 20090716 OTC MONOGRAPH FINAL part341 CVS GUAIFENESIN 100 mg/5mL 59779-311_db8965c9-0ca7-469f-b4a5-c6041303ade7 59779-311 HUMAN OTC DRUG Everyday Clean Pyrithione Zinc SHAMPOO TOPICAL 20060210 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc PYRITHIONE ZINC 1 g/100mL 59779-313_4be1844f-49bd-4f1b-9421-0a241779417e 59779-313 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20040507 ANDA ANDA075217 CVS Pharmacy IBUPROFEN 50 mg/1.25mL 59779-314_9f5786d3-ab17-4cd7-8344-d40d638b92b9 59779-314 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090209 OTC MONOGRAPH NOT FINAL part356 CVS HYDROGEN PEROXIDE 2.65 mL/100mL 59779-316_5d20049e-d3bd-4543-a14a-389257ff6d0a 59779-316 HUMAN OTC DRUG CVS Psoriasis Medicated SALICYLIC ACID SHAMPOO TOPICAL 20100716 OTC MONOGRAPH FINAL part358H CVS Pharmacy SALICYLIC ACID 30 mg/mL 59779-317_9e42e976-631f-4836-840c-de9bd5bde4e3 59779-317 HUMAN OTC DRUG CVS DRY SKIN THERAPY WITH SPF 15 ENSULIZOLE, OCTISALATE AND OCTOCRYLENE LOTION TOPICAL 20100719 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy ENSULIZOLE; OCTISALATE; OCTOCRYLENE 10; 40; 10 mg/mL; mg/mL; mg/mL 59779-318_a4afd246-11e9-4aef-9a22-ec9d38142e7a 59779-318 HUMAN OTC DRUG HYDROCORTISONE HYDROCORTISONE LIQUID TOPICAL 20100716 OTC MONOGRAPH FINAL part348 CVS Pharmacy HYDROCORTISONE 10 mg/mL 59779-319_ce3b4150-b828-44f0-9a69-2c312a8245e7 59779-319 HUMAN OTC DRUG Cortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20120222 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy HYDROCORTISONE 1 g/100g 59779-320_2b5d0665-a2a0-4b02-ab92-995d3074a814 59779-320 HUMAN OTC DRUG DAILY MOISTURIZING WITH NATURAL COLLOIDAL OATMEAL DIMETHICONE LOTION TOPICAL 20100625 OTC MONOGRAPH FINAL part347 CVS PHARMACY INC DIMETHICONE 1.25 mL/100mL 59779-321_ef9e122e-e550-495d-b5d7-1e83521840c7 59779-321 HUMAN OTC DRUG SKIN RELIEF MOISTURE LOT WITH SOOTHING OAT EXTRACTS DIMETHICONE LIQUID TOPICAL 20110117 OTC MONOGRAPH FINAL part347 CVS PHARMACY DIMETHICONE 1.3 mL/100mL 59779-322_8eed5c4e-8e20-43f6-88b2-a04be7c50a6f 59779-322 HUMAN OTC DRUG HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 20090519 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy HYDROCORTISONE 10 mg/g 59779-323_175de196-6021-4a01-901e-d3a6a8dc2182 59779-323 HUMAN OTC DRUG CVS daily moisturizing with natural colloidal oatmeal Dimethicone LOTION TOPICAL 20101013 OTC MONOGRAPH FINAL part347 CVS Pharmacy Inc DIMETHICONE 1.3 mL/100mL 59779-323_b0626b8f-3921-4627-836a-b2ec0ed8c4e5 59779-323 HUMAN OTC DRUG CVS daily moisturizing with natural colloidal oatmeal Dimethicone LOTION TOPICAL 20101013 OTC MONOGRAPH FINAL part347 CVS Pharmacy Inc DIMETHICONE 1.3 mL/100mL 59779-323_fdc0da77-0c37-4608-9bd5-c16d48d89c9c 59779-323 HUMAN OTC DRUG CVS daily moisturizing with natural colloidal oatmeal Dimethicone LOTION TOPICAL 20110921 OTC MONOGRAPH FINAL part347 CVS Pharmacy Inc DIMETHICONE 1.3 mL/100mL 59779-324_5ca340b7-8cb9-4a04-9a67-10fee4b3aa52 59779-324 HUMAN OTC DRUG DAILY MOISTURIZING DIMETHICONE LOTION TOPICAL 20111103 OTC MONOGRAPH FINAL part347 CVS PHARMACY DIMETHICONE 1.3 g/100g 59779-326_81bfb623-57f7-4a15-877f-5b2184a2e871 59779-326 HUMAN OTC DRUG ILLUMINATING DAILY MOISTURIZER SPF 30 HOMOSALATE LOTION TOPICAL 20100804 OTC MONOGRAPH FINAL part352 CVS PHARMACY INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 12; 5; 1.7; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 59779-327_b95209ae-6869-4bd2-9cb1-fcac811399a3 59779-327 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED BISACODYL 5 mg/1 59779-328_6cb0dbc9-8a00-4e02-93f5-713ed8db26b8 59779-328 HUMAN OTC DRUG sore throat spray Phenol SPRAY ORAL 20050606 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy PHENOL 10.268 mg/100mL 59779-329_c953b1c1-ba80-4d9b-a31d-49353d41b428 59779-329 HUMAN OTC DRUG nasal original Oxymetazoline HCl SPRAY NASAL 19890915 OTC MONOGRAPH FINAL part341 CVS Pharmacy OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 59779-330_0ce1f17b-1ae8-43b8-b65e-1389eb0e7088 59779-330 HUMAN OTC DRUG Ketotifen Fumarate Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20130221 ANDA ANDA077958 CVS Pharmacy KETOTIFEN FUMARATE .35 mg/mL 59779-330_fdc7d2a2-efe6-43e3-8f1d-27b706d262af 59779-330 HUMAN OTC DRUG Ketotifen Fumarate Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20131011 ANDA ANDA077958 CVS Pharmacy KETOTIFEN FUMARATE .35 mg/mL 59779-331_f6246c49-af1b-4eb0-b4f7-0b147fac8ecf 59779-331 HUMAN OTC DRUG MOISTURIZING HAND CITRUS COCONUT BENZALKONIUM CHLORIDE LOTION TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE .1 mL/100mL 59779-332_00efa226-24b1-4852-b31d-9bbf91adcb23 59779-332 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide LIQUID ORAL 19920810 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy MAGNESIUM HYDROXIDE 1200 mg/15mL 59779-333_04f56ae2-1709-436a-b5ef-ce6d0726209a 59779-333 HUMAN OTC DRUG enema mineral oil disposable Mineral Oil LIQUID RECTAL 20091202 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy MINERAL OIL 100 mL/100mL 59779-334_727e7651-8a9f-40f4-bbfd-a9d7d40d2524 59779-334 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin and Caffeine TABLET, FILM COATED ORAL 20080313 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 59779-335_2f314477-caf8-4abb-ab10-62562bd65c21 59779-335 HUMAN OTC DRUG Nighttime Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110816 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 59779-336_59d0f3f6-06f2-43f1-b220-4eedeb32e663 59779-336 HUMAN OTC DRUG Acetaminophen 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 CVS Pharmacy ACETAMINOPHEN 650 mg/1 59779-337_f74e08f2-e181-43de-86ee-a2fa25252894 59779-337 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20100831 OTC MONOGRAPH FINAL part349 CVS Pharmacy WATER 99.05 mL/100mL 59779-338_2c9d9699-9fd1-4f7f-8ee2-6033b159cc45 59779-338 HUMAN OTC DRUG Backache Relief Magnesium Salicylate TABLET, FILM COATED ORAL 19981107 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED MAGNESIUM SALICYLATE 580 mg/1 59779-339_3b5c7643-2484-4a25-bb1f-a3d1065068a8 59779-339 HUMAN OTC DRUG ANTIBACTERIAL MOISTURIZING HAND LOTION SUN BLOSSOM BENZALKONIUM CHLORIDE LOTION TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE .1 mL/100mL 59779-340_6d59e492-cf61-43aa-af10-4e0bfc2e38b4 59779-340 HUMAN OTC DRUG ARTHRITIS PAIN RELIEF Acetaminophen TABLET, EXTENDED RELEASE ORAL 20140214 ANDA ANDA078569 CVS PHARMACY ACETAMINOPHEN 650 mg/1 59779-340_b57e5a38-ff6a-4e72-b5e3-3952d785f825 59779-340 HUMAN OTC DRUG ARTHRITIS PAIN RELIEF Acetaminophen TABLET, EXTENDED RELEASE ORAL 20140214 ANDA ANDA078569 CVS PHARMACY ACETAMINOPHEN 650 mg/1 59779-341_79a73ca1-f3c8-42ac-9833-20f1e5606993 59779-341 HUMAN OTC DRUG Athletes Foot Spray Miconazole Nitrate SPRAY TOPICAL 20060302 OTC MONOGRAPH FINAL part333 CVS Pharmacy MICONAZOLE NITRATE 2 g/100g 59779-344_e3a06727-8f72-44a7-b18b-c4d6214d9950 59779-344 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20060222 ANDA ANDA077007 CVS Pharmacy NICOTINE 2 mg/1 59779-345_09e24438-e0c7-4154-bc5a-127b6763e08e 59779-345 HUMAN OTC DRUG Maximum Strength Caffeine Caffeine TABLET ORAL 19980414 OTC MONOGRAPH FINAL part340 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED CAFFEINE 200 mg/1 59779-346_d3429cd4-d609-4e7e-9c59-418b06f5fc4b 59779-346 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20090813 OTC MONOGRAPH FINAL part341 CVS ACETAMINOPHEN 160 mg/5mL 59779-347_97752881-dbbb-42db-804f-8c0529683ac7 59779-347 HUMAN OTC DRUG INFANTS COUGH SYRUP DROSERA ROTUNDIFOLIA, BRYONIA ALBA, IPECACUANHA, SPONGIA TOSTA, CAUSTICUM, PHOSPHORUS, RUMEX CRISPUS SYRUP ORAL 20140221 UNAPPROVED HOMEOPATHIC CVS PHARMACY BRYONIA ALBA ROOT; CAUSTICUM; DROSERA ROTUNDIFOLIA; IPECAC; PHOSPHORUS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 6; 6; 6; 12; 6; 6 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 59779-348_afa3867d-e320-4fa5-95ad-4807af6ac7ab 59779-348 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20030104 OTC MONOGRAPH NOT FINAL part334 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED SENNOSIDES A AND B 25 mg/1 59779-349_67b3c625-2aa5-44eb-88a9-21d2eaf7af1e 59779-349 HUMAN OTC DRUG Intense CVS Intense Toothache Benzocaine PASTE, DENTIFRICE TOPICAL 20110120 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 20 g/100g 59779-350_fcd17069-6b5c-46cc-aed9-0d735da363ba 59779-350 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 CVS Pharmacy ACETAMINOPHEN 650 mg/1 59779-351_10abea2c-ca51-446f-8a6e-903acb1de063 59779-351 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 19950921 OTC MONOGRAPH NOT FINAL part334 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DOCUSATE SODIUM 100 mg/1 59779-352_07afa317-874b-4da6-bf3b-23a042e82340 59779-352 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070915 ANDA ANDA078547 CVS Pharmacy NICOTINE 2 mg/1 59779-354_995f33ab-158c-47f0-9c00-9bee7644c183 59779-354 HUMAN OTC DRUG ACID REDUCER Ranitidine TABLET ORAL 20120821 ANDA ANDA200536 CVS Pharmacy RANITIDINE HYDROCHLORIDE 150 mg/1 59779-355_8e05c8f0-97bd-4ba7-9054-bad9cdaa0f1e 59779-355 HUMAN OTC DRUG ECZEMA CARE COLLOIDAL OATMEAL LOTION TOPICAL 20121203 OTC MONOGRAPH FINAL part347 CVS PHARMACY OATMEAL 10 mg/mL 59779-356_f1bdb38f-d139-442c-ba58-6fb3bcd0a4b8 59779-356 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130919 ANDA ANDA201745 CVS Pharmacy, Inc RANITIDINE HYDROCHLORIDE 75 mg/1 59779-357_09d23d78-a581-4bd7-9b64-85be403bd8bb 59779-357 HUMAN OTC DRUG Antacid Regular Strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19900515 OTC MONOGRAPH FINAL part331 CVS Pharmacy ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 59779-358_7b79f57b-54a8-4188-9d32-2ad0180c168f 59779-358 HUMAN OTC DRUG CVS PHARMACY BABY MOISTURIZING DIMETHICONE LIQUID TOPICAL 20140623 OTC MONOGRAPH FINAL part347 CVS PHARMACY DIMETHICONE 12 mg/mL 59779-359_96dc923e-bb9c-4ffe-8832-a28c41c47ee1 59779-359 HUMAN OTC DRUG Tussin DM Adult cough and chest congestion Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 19910924 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 59779-360_902199d4-b806-4727-9953-a86466df4b30 59779-360 HUMAN OTC DRUG PAIN RELIEF PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20100708 OTC MONOGRAPH FINAL part338 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 59779-363_3cbef359-4184-4ab4-8a84-e6fb6d843792 59779-363 HUMAN OTC DRUG Cold and Cough childrens Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20060817 OTC MONOGRAPH FINAL part341 CVS Pharmacy BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 59779-365_df06ca1b-518c-4796-9f43-5b2c3523c63d 59779-365 HUMAN OTC DRUG Naphazoline Hydrochloride and Pheniramine Maleate Naphazoline hydrochloride and Pheniramine Maleate SOLUTION/ DROPS OPHTHALMIC 20130125 ANDA ANDA202795 CVS Pharmacy NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .25; 3 mg/mL; mg/mL 59779-366_3394c53a-8c0e-4ebd-b685-ee46c307e179 59779-366 HUMAN OTC DRUG ALLERGY EYE DROPS Naphazoline hydrochloride and Pheniramine Maleate SOLUTION/ DROPS OPHTHALMIC 20130125 ANDA ANDA202795 CVS Pharmacy NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .25; 3 mg/mL; mg/mL 59779-367_ca2f4fd5-6eda-412f-bb10-6a19c893045f 59779-367 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59779-368_53d088d5-7c51-470f-b943-34ba3d80e7fc 59779-368 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 19970123 ANDA ANDA074661 CVS Pharmacy NAPROXEN SODIUM 220 mg/1 59779-369_8a053d7e-f85c-4f73-8fa1-461b21f09ce6 59779-369 HUMAN OTC DRUG cortisone maximum strength Hydrocortisone CREAM TOPICAL 20100105 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy HYDROCORTISONE 1 g/100g 59779-370_1e7043dc-d5e0-41c7-843b-39ca81f272b4 59779-370 HUMAN OTC DRUG BABY COUGH SYRUP DROSERA ROTUNDIFOLIA, BRYONIA ALBA, IPECACUANHA, SPONGIA TOSTA, CAUSTICUM, PHOSPHORUS, RUMEX CRISPUS SYRUP ORAL 20140106 UNAPPROVED HOMEOPATHIC CVS PHARMACY BRYONIA ALBA ROOT; CAUSTICUM; DROSERA ROTUNDIFOLIA; IPECAC; PHOSPHORUS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 6; 6; 6; 12; 6; 6 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 59779-371_0e7d7530-400a-4b48-ac51-ee4ad705d680 59779-371 HUMAN OTC DRUG BABY TINY COLD EUPHRASIA OFFICINALIS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, KALI IODATUM TABLET, ORALLY DISINTEGRATING ORAL 20140106 UNAPPROVED HOMEOPATHIC CVS PHARMACY EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 6; 6; 6; 6 [hp_X]/1251; [hp_X]/1251; [hp_X]/1251; [hp_X]/1251 59779-372_e0a49252-972b-4838-b115-73d67dfdb782 59779-372 HUMAN OTC DRUG BABY TEETHING CHAMOMILLA, CALCAREA PHOSPHORICA, COFFEA CRUDA, BELLADONNA TABLET, ORALLY DISINTEGRATING ORAL 20140106 UNAPPROVED HOMEOPATHIC CVS PHARMACY ATROPA BELLADONNA WHOLE; CALCIUM PHOSPHATE; CHAMOMILE; COFFEA ARABICA FRUIT 12; 6; 6; 6 [hp_X]/1351; [hp_X]/1351; [hp_X]/1351; [hp_X]/1351 59779-373_304eb254-d0cd-4573-8303-4f44b2a20548 59779-373 HUMAN OTC DRUG Pain Relief PM Acetaminophen and Diphenhydramine Citrate TABLET ORAL 20040607 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 59779-374_9221fe79-93a0-4ad5-9ff3-f429164a759a 59779-374 HUMAN OTC DRUG migraine relief acetaminophen, aspirin, caffeine TABLET ORAL 20020827 ANDA ANDA075794 CVS Pharmacy ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 59779-375_5eb97dee-4c71-451b-9405-2dd6c59c6e5f 59779-375 HUMAN OTC DRUG Anti-Diarrheal Loperamides TABLET ORAL 20050503 ANDA ANDA076497 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED LOPERAMIDE HYDROCHLORIDE 2 mg/1 59779-376_5b207872-124b-4e35-a9d6-d4854d5fcf4e 59779-376 HUMAN OTC DRUG CVS VANISHING SCENT MUSCLE RUB MENTHOL GEL TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part348 CVS PHARMACY MENTHOL 2.5 g/100g 59779-377_43c4571d-1a08-411f-b555-0e0e267d708c 59779-377 HUMAN OTC DRUG INFANT COLD EUPHRASIA OFFICINALIS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, KALI IODATUM TABLET, ORALLY DISINTEGRATING ORAL 20140207 UNAPPROVED HOMEOPATHIC CVS PHARMACY EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 6; 6; 6; 6 [hp_X]/1251; [hp_X]/1251; [hp_X]/1251; [hp_X]/1251 59779-378_24e9847f-c8a8-4d12-b823-ba6f38ce97c8 59779-378 HUMAN OTC DRUG ANTI-WRINKLE AND FIRMING BROAD SPECTRUM SPF18 SUNSCREEN Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 5 g/100g; g/100g; g/100g 59779-379_348eef47-345c-44a2-b5ed-85ed8a0742f5 59779-379 HUMAN OTC DRUG Allergy Childrens Diphenhydramine Hydrochloride LIQUID ORAL 19870715 OTC MONOGRAPH FINAL part341 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 59779-380_7ce9bdb8-b5ad-4bc4-bcfc-1007972840f4 59779-380 HUMAN OTC DRUG hair regrowth treatment for men Minoxidil SOLUTION TOPICAL 20050718 ANDA ANDA075598 CVS Pharmacy MINOXIDIL 5 g/100mL 59779-381_61366ebb-6bd7-4d25-b081-ae652e1dbc14 59779-381 HUMAN OTC DRUG CVS CAPSAICIN CAPSAICIN CREAM TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part348 CVS PHARMACY CAPSAICIN .1 g/100g 59779-382_f948abe5-f5c1-4677-a1e9-bfe0c992bcf1 59779-382 HUMAN OTC DRUG Sodium Chloride Sodium Chloride SOLUTION/ DROPS OPHTHALMIC 20130614 OTC MONOGRAPH FINAL part349 CVS Pharmacy SODIUM CHLORIDE 50 mg/mL 59779-384_fd747567-b80f-402f-8b90-438dbbc13663 59779-384 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120828 ANDA ANDA091135 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 59779-386_4f566964-8873-4aee-93c4-7e40d5c240f8 59779-386 HUMAN OTC DRUG Extra Strength Medicated Body Dimethicone LOTION TOPICAL 19921001 OTC MONOGRAPH FINAL part347 CVS Pharmacy, Inc DIMETHICONE; MENTHOL 5; .5 kg/100kg; kg/100kg 59779-388_b71c557a-eb93-40d1-87c4-847f5468fc1e 59779-388 HUMAN OTC DRUG nasal mist Oxymetazoline HCl SPRAY NASAL 20020904 OTC MONOGRAPH FINAL part341 CVS Pharmacy OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 59779-389_3aef91e8-3f25-4871-9ce9-d6268aa8facb 59779-389 HUMAN OTC DRUG Genuine Aspirin Aspirin TABLET ORAL 20010517 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ASPIRIN 325 mg/1 59779-390_521e1440-6dbd-4279-ad1e-94e029a52303 59779-390 HUMAN OTC DRUG nose Phenylephrine hydrochloride LIQUID NASAL 19910918 OTC MONOGRAPH FINAL part341 CVS Pharmacy PHENYLEPHRINE HYDROCHLORIDE 1 mL/100mL 59779-391_73507931-b33e-4616-8a8f-550e8a09bbee 59779-391 HUMAN OTC DRUG Menstrual Relief Acetaminophen, Caffeine, Pyrilamine maleate CAPSULE, LIQUID FILLED ORAL 20010614 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 59779-392_4227f345-9622-43cc-b0e3-fd51922a67f5 59779-392 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990302 ANDA ANDA075139 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED IBUPROFEN 200 mg/1 59779-393_952a611d-70b1-4046-b9e5-236a4280bafb 59779-393 HUMAN OTC DRUG Ibuprofen IB Ibuprofen TABLET, COATED ORAL 20020408 ANDA ANDA075139 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED IBUPROFEN 200 mg/1 59779-394_93e9578d-ed75-4dc8-a565-ac2d117e4bf5 59779-394 HUMAN OTC DRUG Hemorrhoidal Cocoa butter, Phenylephrine HCl, Shark liver oil SUPPOSITORY RECTAL 20050609 OTC MONOGRAPH FINAL part346 CVS Pharmacy COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2137.5; 75; 6.375 mg/1; mg/1; mg/1 59779-395_221a6437-5661-4c92-bba4-0e5296dd9572 59779-395 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate Magnesium sulfate GRANULE ORAL; TOPICAL 20141231 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy MAGNESIUM SULFATE 1 g/g 59779-396_7d64f007-dbe0-48cf-9f9e-176d1c4e15aa 59779-396 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide LIQUID ORAL 19920807 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy MAGNESIUM HYDROXIDE 1200 mg/15mL 59779-397_b3980498-9de5-4948-b799-63fd1f7e85ed 59779-397 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 19980623 ANDA ANDA090711 CVS Pharmacy NICOTINE 2 mg/1 59779-398_d7142db6-14d7-43ab-b0dd-64459a2be200 59779-398 HUMAN OTC DRUG DIBUCAINE DIBUCAINE CREAM TOPICAL 20100716 OTC MONOGRAPH FINAL part346 CVS Pharmacy DIBUCAINE 10 mg/g 59779-399_de6ea099-3261-4190-9166-b98319cbbdc3 59779-399 HUMAN OTC DRUG MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM TOPICAL 20100716 OTC MONOGRAPH FINAL part346 CVS Pharmacy MINERAL OIL; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 466; 10; 125 mg/g; mg/g; mg/g 59779-400_23a1e49f-9e75-49a9-9b54-61bb9d9c2d93 59779-400 HUMAN OTC DRUG Hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 20070605 OTC MONOGRAPH FINAL part346 CVS Pharmacy MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g 59779-401_01e14dd4-f3d2-4aee-89d5-c1df553f1ffd 59779-401 HUMAN OTC DRUG COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY RECTAL 20110701 OTC MONOGRAPH FINAL part346 CVS COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE .855; .0025 g/g; g/g 59779-402_7cc04444-96d2-4a70-9c29-668987757086 59779-402 HUMAN OTC DRUG Cold Relief Head Congestion Daytime Non-Drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20090612 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 59779-403_781a477f-015c-47a0-9706-162cd1b60e82 59779-403 HUMAN OTC DRUG CVS Hemorrhoidal PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM CREAM TOPICAL 20101215 OTC MONOGRAPH FINAL part346 CVS Pharmacy GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 144; 150; 2.5; 10 mg/g; mg/g; mg/g; mg/g 59779-404_a52352f0-bfe5-4dd5-a4d3-952c466ba412 59779-404 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET, CHEWABLE ORAL 20020529 OTC MONOGRAPH FINAL part336 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED MECLIZINE HYDROCHLORIDE 25 mg/1 59779-405_4932d326-3c72-41f2-95ea-5372c9226c0c 59779-405 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET ORAL 19910615 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 59779-406_2a3fa9bd-1ca9-4212-992e-c793a6c8cfe0 59779-406 HUMAN OTC DRUG CVS Cold Sore Treatment Benzalkonium Chloride CREAM TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE 1.3 mg/g 59779-407_6eed2be4-5f6e-479c-a1b9-f4972bd7da6b 59779-407 HUMAN OTC DRUG nausea relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 19960530 UNAPPROVED DRUG OTHER CVS Pharmacy DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 59779-408_facb509e-3b9c-4634-bf77-5af699b80fcd 59779-408 HUMAN OTC DRUG Refill Saline Packets SODIUM BICARBONATE, SODIUM CHLORIDE POWDER, FOR SOLUTION NASAL 20130401 UNAPPROVED DRUG OTHER CVS Pharmacy SODIUM BICARBONATE; SODIUM CHLORIDE 2300; 700 mg/1; mg/1 59779-409_e64ad72a-ce8c-46e3-8fba-9e8a409f6779 59779-409 HUMAN OTC DRUG Sleep Aid Nighttime Diphenhydramine HCl TABLET ORAL 20130815 OTC MONOGRAPH FINAL part338 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59779-410_8855d505-cae6-43f2-8992-80fde5a6483e 59779-410 HUMAN OTC DRUG CVS Pharmacy Cold and Sore Throat Lemon Flavor Acetaminophen, Pheniramine Maleate, Phenylephrine HCl GRANULE, FOR SOLUTION ORAL 20130401 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 20; 10 mg/1; mg/1; mg/1 59779-411_28cfdecc-c47b-45fb-9add-44a2c2b32a04 59779-411 HUMAN OTC DRUG Cough and Cold Chlorpheniramine maleate and Dextromethorphan HBr TABLET ORAL 20030503 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 59779-412_0550397d-2804-4005-9d85-f83d78297e6d 59779-412 HUMAN OTC DRUG Tussin CF Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL 59779-413_d365e383-cb20-4bb9-8c51-70528a9653a4 59779-413 HUMAN OTC DRUG ibuprofen pm Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20100302 ANDA ANDA079113 CVS Pharmacy DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 59779-414_5dd1aecb-0841-448d-876f-e26b9a1554bd 59779-414 HUMAN OTC DRUG Adult Low Strength Aspirin Aspirin TABLET, COATED ORAL 20040114 20151120 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ASPIRIN 81 mg/1 59779-415_6645108a-3657-46eb-9c59-1d2ef8d13cc7 59779-415 HUMAN OTC DRUG Indoor/Outdoor ALLERGY RELIEF Softgels Cetirizine Hydrochloride CAPSULE ORAL 20130301 NDA NDA022429 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 10 mg/1 59779-416_797fed9a-b9d4-4133-a908-e032db34d127 59779-416 HUMAN OTC DRUG Aspirin Regular Strength Aspirin TABLET ORAL 19910615 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 325 mg/1 59779-417_48ab6f9f-fc15-4a7b-85e9-a87639396f80 59779-417 HUMAN OTC DRUG Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130815 ANDA ANDA076518 CVS Pharmacy NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 59779-419_24190006-4f8e-40e7-b8c8-6a697ecfa6e3 59779-419 HUMAN OTC DRUG chest congestion childrens plus cough Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20090311 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 59779-420_34320e65-e147-4166-b3cf-b595cf45bfc8 59779-420 HUMAN OTC DRUG Hair Regrowth Treatment for Men Minoxidil SOLUTION TOPICAL 19910904 ANDA ANDA075357 CVS Pharmacy MINOXIDIL 2 g/100mL 59779-421_1347ce59-5b40-4176-b104-03730d063342 59779-421 HUMAN OTC DRUG FRUITOPIA PYRITHIONE ZINC LIQUID TOPICAL 20120217 OTC MONOGRAPH FINAL part358H CVS PHARMACY PYRITHIONE ZINC 1 mL/100mL 59779-422_af0fba1d-8dc3-4f1e-89e3-db97c30d25d1 59779-422 HUMAN OTC DRUG BLADE HOWL ANTI-DANDRUFF PYRITHIONE ZINC SHAMPOO TOPICAL 20101103 OTC MONOGRAPH FINAL part358H CVS PHARMACY INC PYRITHIONE ZINC 1 mL/100mL 59779-424_cb9189d6-0593-426d-8ff5-357a4c9180f6 59779-424 HUMAN OTC DRUG nicotine Nicotine polacrilex LOZENGE ORAL 20100512 ANDA ANDA090821 CVS Pharmacy NICOTINE 4 mg/1 59779-425_09cd4e81-28df-40e8-b22d-a2be2b07fc23 59779-425 HUMAN OTC DRUG Allergy relief Fexofenadine HCl TABLET, FILM COATED ORAL 20110831 ANDA ANDA076447 CVS Pharmacy FEXOFENADINE HYDROCHLORIDE 60 mg/1 59779-426_63b7fdba-8cc4-4a4b-b1f2-587ddc1305b6 59779-426 HUMAN OTC DRUG CVS Extra Strength Cold and Hot Medicated Patch Menthol PATCH TOPICAL 20140407 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. MENTHOL 750 mg/1 59779-427_d36c6041-cdb2-491f-b74b-c28ad692ec0b 59779-427 HUMAN OTC DRUG Oil Free Acne Cleansing Towelette Salicylic acid CLOTH TOPICAL 20130722 OTC MONOGRAPH FINAL part333D CVS Pharmacy SALICYLIC ACID 20.5 mg/mL 59779-428_53863b72-f93a-4076-816a-f0b411b0ca88 59779-428 HUMAN OTC DRUG CVS PHARMACY DANDRUFF PYRITHIONE ZINC LIQUID TOPICAL 20131205 OTC MONOGRAPH FINAL part358H CVS PHARMACY PYRITHIONE ZINC 10 mg/mL 59779-429_dad9a940-f16a-4695-929e-1d6b9449757e 59779-429 HUMAN OTC DRUG Infants Pain and Fever acetaminophen suspension SUSPENSION ORAL 20140117 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL 59779-430_ba5cb472-6757-43b8-88e0-861a3b8207dc 59779-430 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011011 ANDA ANDA074567 CVS Pharmacy IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 59779-431_584ca686-2085-448c-a370-fda370d379d2 59779-431 HUMAN OTC DRUG sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20001003 OTC MONOGRAPH FINAL part338 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59779-432_17965318-3c59-4dc4-882c-fc3e0efe96bb 59779-432 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 19870715 OTC MONOGRAPH FINAL part341 CVS Pharmacy PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 59779-433_d8a0fa00-04fd-4ae7-9331-902615dca7c1 59779-433 HUMAN OTC DRUG tussin Dextromethorphan Hydrobromide SOLUTION ORAL 19920513 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL 59779-434_729c3158-352a-4b66-b78a-8557a52d8d0b 59779-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20140501 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 59779-438_a127fc17-80ae-46ab-904d-68d1328a1103 59779-438 HUMAN OTC DRUG Dye Free Ibuprofen Ibuprofen TABLET ORAL 20040311 ANDA ANDA075139 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED IBUPROFEN 200 mg/1 59779-439_f1811c03-3208-45e7-bce2-e5b59a42011e 59779-439 HUMAN OTC DRUG Enteric Aspirin Aspirin TABLET, COATED ORAL 20040414 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ASPIRIN 81 mg/1 59779-440_2c6037bb-e4c8-427b-9ab0-69b1456d6fbb 59779-440 HUMAN OTC DRUG CVS OIL FREE SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140620 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100g; g/100g; g/100g; g/100g 59779-441_05050b61-2417-48f0-9478-c39d6a341026 59779-441 HUMAN OTC DRUG NIGHTTIME SLEEP AID Doxylamine succinate TABLET ORAL 19970723 ANDA ANDA040167 CVS Pharmacy DOXYLAMINE SUCCINATE 25 mg/1 59779-442_8e6754eb-8df3-4404-81ad-f1431a4d5f62 59779-442 HUMAN OTC DRUG Long Acting Tussin Cough Gels Dextromethorphan HBr CAPSULE, GELATIN COATED ORAL 20060424 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 59779-444_660f28e6-f6c7-4932-b58a-851cf137b401 59779-444 HUMAN OTC DRUG CVS Maximum Strength Boil Relief Benzocaine OINTMENT TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. BENZOCAINE 20 g/100g 59779-446_f81ba803-d700-4c37-849b-91f007232830 59779-446 HUMAN OTC DRUG Childrens Allergy Relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 CVS Pharmacy LORATADINE 5 mg/5mL 59779-447_23aa5dea-ef6c-47f9-84ce-2277feffadac 59779-447 HUMAN OTC DRUG Childrens Pain Relief Bubblegum Acetaminophen TABLET, CHEWABLE ORAL 20050203 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN 80 mg/1 59779-449_62afce5a-0eab-43fc-9b13-72dcba0ba9bf 59779-449 HUMAN OTC DRUG Junior Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN 160 mg/1 59779-450_1932e18e-fc26-44a6-8d95-ba75c8f54131 59779-450 HUMAN OTC DRUG Junior Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN 160 mg/1 59779-452_49941e52-a13e-480e-a319-f80f37bb4ab8 59779-452 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20041206 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN 80 mg/1 59779-453_5d40122c-9364-41b0-a609-d2a7b3269f2b 59779-453 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 59779-455_637cee87-1362-4d24-a50d-155fb51711ce 59779-455 HUMAN OTC DRUG SINUS PAIN AND CONGESTION NIGHTTIME Acetaminophen, Chlorpheniramine Maleate and Phenylephrine HCl TABLET ORAL 20050628 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 59779-456_9ccb0bf3-d54f-44ef-a4dd-8c88f9f4e0ab 59779-456 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061026 ANDA ANDA076777 CVS Pharmacy NICOTINE 2 mg/1 59779-458_5105316d-c7cd-441f-931e-90fc85d1c891 59779-458 HUMAN OTC DRUG Allergy Relief Indoor and Outdoor Allergies Cetirizine Hydrochloride TABLET ORAL 20090114 ANDA ANDA078336 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 10 mg/1 59779-459_b6f5c17e-a4cb-438f-9bbb-24d067b73e4e 59779-459 HUMAN OTC DRUG nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110812 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 59779-460_7cc96cb8-c3d3-4f86-a3eb-3b3e4d439ea5 59779-460 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20090707 OTC MONOGRAPH NOT FINAL part334 CVS MINERAL OIL 15 mL/15mL 59779-461_eac46790-237e-479d-8cb6-cab3fed78ac6 59779-461 HUMAN OTC DRUG Flu Relief BP Acetaminophen, Dextromethorphan HBr, Chlorpheniramine maleate TABLET, FILM COATED ORAL 20050601 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 500; 2; 15 mg/1; mg/1; mg/1 59779-462_e047edf1-5ac7-46bf-80db-084f9c022602 59779-462 HUMAN OTC DRUG Allergy diphenhydramine hydrochloride CAPSULE ORAL 19871215 OTC MONOGRAPH FINAL part341 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59779-463_be121beb-872d-4b7b-9195-2be2187624aa 59779-463 HUMAN OTC DRUG allergy relief Chlorpheniramine Maleate TABLET ORAL 19870715 OTC MONOGRAPH FINAL part341 CVS Pharmacy CHLORPHENIRAMINE MALEATE 4 mg/1 59779-464_f6056034-dc9a-e617-fd3f-1eb3d7dbd43a 59779-464 HUMAN OTC DRUG Allergy and Sinus Headache Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET ORAL 20050615 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER, INCORPORATED ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 59779-465_2f173fc2-9649-4024-b52f-8ebc4a065b5a 59779-465 HUMAN OTC DRUG Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130603 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 59779-466_e42ef687-37c6-4a0a-ae4b-9dddbad6d102 59779-466 HUMAN OTC DRUG SINUS PAIN AND CONGESTION Acetaminophen and Phenylephrine HCl TABLET ORAL 20050726 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 59779-467_9bbd86af-926e-48d0-9109-151a9ac62b09 59779-467 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 19920825 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 81 mg/1 59779-468_37e30616-56c4-4d3c-9436-d03f249ff280 59779-468 HUMAN OTC DRUG ESSENCE OF BEAUTY JAPANESE GARDEN ANTIBACTERIAL ETHYL ALCOHOL LIQUID TOPICAL 20120611 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 62 mL/100mL 59779-469_92b7fa57-bd3a-4211-a430-8675447a8ad8 59779-469 HUMAN OTC DRUG CVS Extra Strength Cold and Hot Pain Relieving Menthol CREAM TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part348 CVS MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g 59779-470_bddddfc8-2fdf-7e68-7422-1c1656705a87 59779-470 HUMAN OTC DRUG Head Congestion Cold Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET, FILM COATED ORAL 20060611 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER, INCORPORATED ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 59779-471_cb356816-b415-469b-acc3-4e10a3f7a20f 59779-471 HUMAN OTC DRUG cortisone hydrocortisone OINTMENT TOPICAL 20050610 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy HYDROCORTISONE 1 g/100g 59779-472_0bca9120-e7f2-482b-b2e4-94366b296b2a 59779-472 HUMAN OTC DRUG Daytime Cold Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130531 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 59779-473_6012a1ca-ed31-f73c-c431-5bef413041e5 59779-473 HUMAN OTC DRUG Head Congestion Cold Relief Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl TABLET, FILM COATED ORAL 20050721 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER, INCORPORATED ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 59779-474_80dc31f9-9c4c-477e-89b9-a827efb40391 59779-474 HUMAN OTC DRUG ESSENCE OF BEAUTY LILIES AND FREESIA ETHYL ALCOHOL LIQUID TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 620 mg/mL 59779-475_b7cd042b-fc3b-4102-ac69-b8defccf1da3 59779-475 HUMAN OTC DRUG CVS Extra Strength Cold and Hot Medicated Menthol PATCH TOPICAL 20130920 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. MENTHOL 750 mg/1 59779-476_20c8b208-52ee-408c-84ef-c82afd4014bb 59779-476 HUMAN OTC DRUG CVS Ultra Strength Pain Relieving Menthol PATCH TOPICAL 20130920 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. MENTHOL 750 mg/1 59779-479_eae23b64-c07b-48c5-b563-72eeb208fa9f 59779-479 HUMAN OTC DRUG allergy Diphenhydramine Hydrochloride TABLET ORAL 19910814 OTC MONOGRAPH FINAL part341 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59779-480_0ab313a5-ba94-4917-b75d-f6cef4e20af6 59779-480 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090326 OTC MONOGRAPH FINAL part333 CVS ISOPROPYL ALCOHOL 91 mL/100mL 59779-481_cf0f12c7-323f-41b6-8ed9-a38b8266c188 59779-481 HUMAN OTC DRUG ESSENCE OF BEAUTY CITRUS COCONUTI ETHYL ALCOHOL LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 620 mg/mL 59779-482_825c3b97-9986-417b-9063-5b5273098bbd 59779-482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20120203 OTC MONOGRAPH FINAL part355 CVS Pharmacy, Inc SODIUM FLUORIDE .1 mg/mL 59779-483_376eefed-ee1c-46b3-bd83-c1e208993986 59779-483 HUMAN OTC DRUG ESSENCE OF BEAUTY WIND KISSED ETHYL ALCOHOL LIQUID TOPICAL 20130702 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 620 mg/mL 59779-484_dfa607de-12cc-41ed-a58a-cdbed862bf9d 59779-484 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET ORAL 19910715 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 59779-485_ffd0ee4b-0e64-47c3-861a-0fa9ab27a18f 59779-485 HUMAN OTC DRUG ESSENCE OF BEAUTY VANILLA WISHES ETHYL ALCOHOL LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL 59779-488_9ce9f574-6925-4001-8819-b367acc050c1 59779-488 HUMAN OTC DRUG ESSENCE OF BEAUTY LILIES AND FREESIA ETHYL ALCOHOL LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 620 mg/mL 59779-489_58211d72-d593-4a71-8656-ce40df8df6f2 59779-489 HUMAN OTC DRUG ESSENCE OF BEAUTY SUGAR FROSTED MINT ETHYL ALCOHOL LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL 59779-490_f9fa31f2-5c7c-4b4c-b7a6-a9c085a179b3 59779-490 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 19970123 ANDA ANDA074661 CVS Pharmacy NAPROXEN SODIUM 220 mg/1 59779-491_acaa4610-c82a-4d0a-8fdf-fa30e3fdcf49 59779-491 HUMAN OTC DRUG Daytime Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130531 OTC MONOGRAPH FINAL part341 CVS Pharmacy 59779-493_3967c683-70db-418d-865c-5bfa51f84c33 59779-493 HUMAN OTC DRUG ESSENCE OF BEAUTY JAPANESE GARDEN ETHYL ALCOHOL LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 620 mg/mL 59779-494_18daa05c-d3cf-4b98-b44e-fe12f166dcf7 59779-494 HUMAN OTC DRUG ESSENCE OF BEAUTY SNOWY APPLE ETHYL ALCOHOL LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL 59779-495_dc31c80d-b551-4eaa-aded-3ab189ca3b5d 59779-495 HUMAN OTC DRUG CVS Moisturizing Lubricating Eye Twin Pack Carboxymethylcellulose Sodium Glycerin SOLUTION/ DROPS OPHTHALMIC 20140710 OTC MONOGRAPH FINAL part349 CVS Pharmacy, Inc. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL 59779-496_d05ff791-57fd-46f5-93b5-a6f796be7d37 59779-496 HUMAN OTC DRUG CVS Long Lasting Lubricant Eye Twin Pack Polyethylene Glycol 400 Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20140710 OTC MONOGRAPH FINAL part349 CVS Pharmacy, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL 59779-497_e2a17059-a2d2-44ec-b022-c53d6170f36e 59779-497 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20090505 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc COAL TAR 10.2 mg/mL 59779-498_c7e3c5d0-6e73-437f-8b87-0d59fac66da8 59779-498 HUMAN OTC DRUG mucus extended release Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130319 ANDA ANDA078912 CVS Pharmacy GUAIFENESIN 600 mg/1 59779-500_bef4b6e0-0745-4ded-94d0-f1e217fb56e6 59779-500 HUMAN OTC DRUG Salicylic Acid Wart Remover Liquid LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part358B CVS Pharmacy SALICYLIC ACID .17 mg/15mL 59779-501_6bddedb4-10f6-4c86-a327-55c7cea83c10 59779-501 HUMAN OTC DRUG First Aid Antibiotic bacitracin zinc OINTMENT TOPICAL 20060425 OTC MONOGRAPH FINAL part333B CVS Pharmacy BACITRACIN ZINC 500 [USP'U]/g 59779-502_549c9da2-2e9e-477d-b5f8-0354a3f11c3d 59779-502 HUMAN OTC DRUG Sinus Pressure Acetaminophen and Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 59779-503_00e3a2ab-fb43-46ec-8045-7bcc1465acd9 59779-503 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080229 NDA NDA022032 CVS Pharmacy OMEPRAZOLE 20 mg/1 59779-504_804da9e6-05eb-4fb3-a138-b77801361b2c 59779-504 HUMAN OTC DRUG Sinus Wash SODIUM BICARBONATE, SODIUM CHLORIDE POWDER, FOR SOLUTION NASAL 20130401 UNAPPROVED DRUG OTHER CVS Pharmacy SODIUM BICARBONATE; SODIUM CHLORIDE 2300; 700 mg/1; mg/1 59779-505_74ed2f85-4eef-467e-b4a8-9afdf5d6df23 59779-505 HUMAN OTC DRUG NUANCE SALMA HAYAK Color and Correct CC Cream Broad Spectrum SPF 20 Sunscreen TITANIUM DIOXIDE CREAM TOPICAL 20141028 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy TITANIUM DIOXIDE 77 mg/mL 59779-510_2027129b-77d7-4b99-902d-b93c49909bc4 59779-510 HUMAN OTC DRUG CVS Pharmacy ITCH RELIEF ANTIFUNGAL Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C CVS Pharmacy CLOTRIMAZOLE 10 mg/g 59779-511_f67824aa-cccc-482b-904a-beb32b927a41 59779-511 HUMAN OTC DRUG Tolnafate Foot and Sneaker Spray AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH FINAL part333C CVS Pharmacy TOLNAFTATE 1.3 g/113g 59779-513_fcc2a617-8703-45c6-9f5e-fcd8b73a8444 59779-513 HUMAN OTC DRUG Miconazole Nitrate Jock Itch Spray AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH FINAL part333C CVS Pharmacy MICONAZOLE NITRATE 1.3 g/131g 59779-514_816a6ca0-8474-4859-9987-bd63c0f6f007 59779-514 HUMAN OTC DRUG CVS Antifungal Ringworm Clotrimazole CREAM TOPICAL 19950601 OTC MONOGRAPH FINAL part333C CVS Pharmacy CLOTRIMAZOLE 1 g/100g 59779-516_c4349190-21e6-4069-a065-6618876b6938 59779-516 HUMAN OTC DRUG Tussin CF Adult Cough and Cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20060721 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 59779-517_93f8101c-1cf7-4cb0-9c00-c57c9f9023c8 59779-517 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060427 ANDA ANDA077349 CVS Pharmacy IBUPROFEN 200 mg/1 59779-519_708d5b46-224c-404b-83b6-e72bbce2019e 59779-519 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN 500 mg/1 59779-520_9172603c-3c9c-4ad4-8db8-46b26dbba781 59779-520 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100708 NDA NDA021855 CVS Pharmacy LOPERAMIDE HYDROCHLORIDE 2 mg/1 59779-521_d3b132ad-5794-4aea-bb20-6e6a9195c6b2 59779-521 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 19911105 ANDA ANDA076359 CVS Pharmacy IBUPROFEN 100 mg/1 59779-522_4b66f3c0-3cc3-40c3-a146-0f24b1853dc4 59779-522 HUMAN OTC DRUG CVS ATHLETES FOOT TOLNAFTATE TOLNAFTATE CREAM TOPICAL 20141010 OTC MONOGRAPH FINAL part333C CVS PHARMACY TOLNAFTATE 10 mg/g 59779-524_4edf8390-d1ed-4f54-8fc4-54d519c23e17 59779-524 HUMAN OTC DRUG Lice Treatment permethrin LOTION TOPICAL 20000401 ANDA ANDA075014 CVS Pharmacy PERMETHRIN 1 mg/100mL 59779-525_a01efbaa-5118-41e6-8384-f31b6c4832ce 59779-525 HUMAN OTC DRUG Cold and Allergy Relief Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20020722 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 59779-526_ac825d18-735f-6052-46fa-14a834979c8c 59779-526 HUMAN OTC DRUG Severe Cold Relief PE Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET, FILM COATED ORAL 20050621 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER, INCORPORATED ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 59779-527_3430eb66-404c-4df7-9eb2-4e37e739df0c 59779-527 HUMAN OTC DRUG Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070927 ANDA ANDA077153 CVS Pharmacy LORATADINE 10 mg/1 59779-528_5d31eb99-1e69-455f-aef2-8c644da326ad 59779-528 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20100108 ANDA ANDA076134 CVS Pharmacy LORATADINE 10 mg/1 59779-529_ffc28420-dc92-46ca-8622-8d98d18443cf 59779-529 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20130822 OTC MONOGRAPH FINAL part332 CVS Pharmacy DIMETHICONE 180 mg/1 59779-530_0590f70a-6ac7-4ae6-96d0-fe375d488349 59779-530 HUMAN OTC DRUG Multi-Symptom Cold Relief Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCl KIT ORAL 20050715 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED 59779-531_d838849c-915a-4f1d-b32a-211cc045cd60 59779-531 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN 500 mg/1 59779-532_c4a6ae2b-b456-4bab-8ad9-1693082732ac 59779-532 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061026 ANDA ANDA076779 CVS Pharmacy NICOTINE 4 mg/1 59779-533_6fea11b5-7bae-4034-9f14-35873ff17f45 59779-533 HUMAN OTC DRUG Athletes Foot Tolnaftate CREAM TOPICAL 20050609 OTC MONOGRAPH FINAL part333C CVS Pharmacy TOLNAFTATE 1 g/100g 59779-535_280eafc2-bfdf-4bce-a24c-c55b07ff9d87 59779-535 HUMAN OTC DRUG CVS Natural Fiber Effervescent Psyllium Husk POWDER ORAL 20140228 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy PSYLLIUM HUSK 3.4 g/5.8g 59779-536_15ea4415-943a-4d0a-ac23-5f37cd2cf206 59779-536 HUMAN OTC DRUG BACITRACIN Bacitracin OINTMENT TOPICAL 20050608 OTC MONOGRAPH FINAL part333 CVS Pharmacy BACITRACIN 500 [USP'U]/g 59779-537_9b1ade7e-a9df-46c0-a84f-9be8bef189ec 59779-537 HUMAN OTC DRUG CVS Bacitracin with Pain Relief BACITRACIN and LIDOCIANE OINTMENT TOPICAL 20100708 OTC MONOGRAPH FINAL part333B CVS Pharmacy BACITRACIN; LIDOCAINE 600; 40 [USP'U]/g; mg/g 59779-543_7d53f690-55cf-4ba7-846a-17f78d085035 59779-543 HUMAN OTC DRUG Severe Allergy And Sinus Headache Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET ORAL 20070627 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 59779-544_43f158ca-1e86-42d2-b08e-ab2831f55a2d 59779-544 HUMAN OTC DRUG arthritis pain relief temporary minor Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000531 ANDA ANDA075077 CVS Pharmacy ACETAMINOPHEN 650 mg/1 59779-546_fc1728ba-98f5-4487-a903-9c06a7232e42 59779-546 HUMAN OTC DRUG complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080826 ANDA ANDA077355 CVS Pharmacy CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 59779-548_6afbdbd5-bb5b-4a4f-9046-230323dca3e5 59779-548 HUMAN OTC DRUG Non-Drying Sinus PE Guaifenesin, Phenylephrine HCl CAPSULE ORAL 20030917 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 200; 5 mg/1; mg/1 59779-549_defb52fb-f92d-4869-aaaf-b44089cb28ae 59779-549 HUMAN OTC DRUG Minoxidil Minoxidil SOLUTION TOPICAL 20141007 ANDA ANDA075598 CVS Pharmacy MINOXIDIL 3 g/60mL 59779-550_d313c9f7-af11-4c2c-a374-cba1e1b2e842 59779-550 HUMAN OTC DRUG Extra Strength Acetaminohpen Adult Rapid Burst Cherry Acetaminophen LIQUID ORAL 20090702 OTC MONOGRAPH FINAL part341 CVS ACETAMINOPHEN 500 mg/5mL 59779-551_dca19daa-aa26-46ed-96d1-012b7c3848b2 59779-551 HUMAN OTC DRUG CVS Medicated Pain-Relieving Camphor, Menthol, Menthyl Salicylate PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. CAMPHOR (SYNTHETIC); MENTHOL; MENTHYL SALICYLATE .012; .057; .063 g/1; g/1; g/1 59779-556_92e1c067-6ef7-485e-8ea9-f9680d9abe63 59779-556 HUMAN OTC DRUG Pain Relief PM Acetaminophen, Diphenhydramin HCl CAPSULE, GELATIN COATED ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 59779-557_7e8c53aa-ab73-4112-bb1c-62a06d107c88 59779-557 HUMAN OTC DRUG Tussin DM Dextromethorphan HBr, Guaifenesin SUSPENSION ORAL 20100728 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 59779-558_b12c7d25-54e3-4dac-9c27-e195af5f84b0 59779-558 HUMAN OTC DRUG SINUS PAIN AND CONGESTION DAYTIME Acetaminophen and Phenylephrine HCl TABLET ORAL 20080317 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 59779-559_9c926561-2cf8-40b9-a753-4aecd75b73bc 59779-559 HUMAN OTC DRUG Allergy Relief Acetaminophen, Phenylephrine HCl, Chlorpheniramine maleate CAPSULE, GELATIN COATED ORAL 20080317 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 59779-560_d115278f-ce1e-4be2-851b-2a63a55fd59b 59779-560 HUMAN OTC DRUG Cold Relief Daytime Multi-Symptom Acetaminophen, Phenylephrine HCl and Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20080329 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 59779-561_8ec27fc7-eef6-4bc7-a06b-f5a369e89513 59779-561 HUMAN OTC DRUG Ear Wax Removal System CARBAMIDE PEROXIDE LIQUID AURICULAR (OTIC) 20050608 OTC MONOGRAPH FINAL part344 CVS Pharmacy CARBAMIDE PEROXIDE 6.5 g/100mL 59779-563_500382c3-c0bb-47a3-8cd5-46183c5f2be9 59779-563 HUMAN OTC DRUG muscle rub Menthol, Methyl salicylate CREAM TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g 59779-566_f2580b2e-f4e6-4279-936e-6ab86ae500d9 59779-566 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20090105 OTC MONOGRAPH FINAL part347 CVS Pharmacy PETROLATUM 1 g/g 59779-567_27f36757-55c4-45b8-8350-5f98a2b78981 59779-567 HUMAN OTC DRUG daytime nighttime multi symptom cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120727 OTC MONOGRAPH FINAL part341 CVS Pharmacy 59779-569_0fd5fbd4-ac34-4a50-bfd6-cedebd352351 59779-569 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part358F CVS Pharmacy SALICYLIC ACID 40 mg/41 59779-570_3ab6367b-091e-42e0-a769-fb424a0cab0c 59779-570 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part358F CVS Pharmacy SALICYLIC ACID 40 mg/91 59779-571_85de4f2a-9d9e-479f-b4c6-9586339760de 59779-571 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin, Caffeine CAPSULE, GELATIN COATED ORAL 20090109 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 59779-572_28e26a4b-6a16-4ed0-8058-91d89b9603d9 59779-572 HUMAN OTC DRUG Tolnaftate Antifungal Continuous Liquid Spray AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH FINAL part333C CVS Pharmacy TOLNAFTATE 1.5 g/150g 59779-574_57149095-3257-4055-9e48-bf72ec90303a 59779-574 HUMAN OTC DRUG Severe Sinus Congestion Acetaminophen TABLET ORAL 20080609 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 325; 200; 30 mg/1; mg/1; mg/1 59779-576_b45c8bd5-1534-4e76-a5de-6c332e8a4cbf 59779-576 HUMAN OTC DRUG Oral Antivavity Sodium fluoride MOUTHWASH ORAL 20130208 OTC MONOGRAPH FINAL part355 CVS Pharmacy SODIUM FLUORIDE 10.41 mg/mL 59779-578_d2191a7a-9a80-4ba6-ba1e-468613ed384d 59779-578 HUMAN OTC DRUG Tussin Sugar Free Cough Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20080924 OTC MONOGRAPH FINAL part341 CVS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 59779-579_9d89544f-3a66-4f23-b609-381d027e0c95 59779-579 HUMAN OTC DRUG fever reducing childrens Acetaminophen SUPPOSITORY RECTAL 20100121 ANDA ANDA070607 CVS Pharmacy ACETAMINOPHEN 120 mg/1 59779-582_54f4c061-d10c-480f-a458-8aabb05642e4 59779-582 HUMAN OTC DRUG CVS Pharmacy Maximum Strength Benzocaine GEL, DENTIFRICE ORAL 20110120 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 20 g/100g 59779-583_eb153f3a-5618-4574-94d8-51b5bbbe5ac9 59779-583 HUMAN OTC DRUG Allergy and Cold Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl CAPSULE, GELATIN COATED ORAL 20090710 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 59779-585_80fa4cbc-63e1-4ee2-bea4-f4695006aa0e 59779-585 HUMAN OTC DRUG Childrens Allergy Antihistamine CVS 44-585 TABLET, ORALLY DISINTEGRATING ORAL 20090320 OTC MONOGRAPH NOT FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 59779-589_5018e832-8d35-454c-839c-fa44d22a1db5 59779-589 HUMAN OTC DRUG Dandruff Selenium sulfide SHAMPOO TOPICAL 20121209 OTC MONOGRAPH FINAL part358H CVS SELENIUM SULFIDE 10 mg/mL 59779-590_d435beaf-fb85-4a4f-bc98-d297ebe0c4f6 59779-590 HUMAN OTC DRUG infants pain and fever acetaminophen LIQUID ORAL 19930430 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL 59779-591_131aec52-5d04-4741-ae75-69ba9163197c 59779-591 HUMAN OTC DRUG Multi-Symptom Cold Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Chlorpheniramine Maleate CAPSULE, LIQUID FILLED ORAL 20080329 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 59779-597_1ec3fc79-4f38-439f-99be-646b82231aa5 59779-597 HUMAN OTC DRUG Severe Nighttime Severe Daytime acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20131227 OTC MONOGRAPH FINAL part341 CVS Pharmacy 59779-600_3d97eb59-76ca-4db5-abef-b9cff0a42a8c 59779-600 HUMAN OTC DRUG Enteric Coated Aspirin Aspirin TABLET ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ASPIRIN 81 mg/1 59779-601_14252d4b-9165-418b-b14d-3c179acbaa48 59779-601 HUMAN OTC DRUG ILLUMINATING DAILY MOISTURIZER SPF 15 AVOBENZONE LOTION TOPICAL 20100804 OTC MONOGRAPH FINAL part352 CVS PHARMACY INC AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 2 mL/100mL; mL/100mL; mL/100mL 59779-602_2e5229b5-cad5-4bb6-8790-923d77b639fd 59779-602 HUMAN OTC DRUG CVS PHARMACY ILLUMINATING AVOBENZONE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20130610 OTC MONOGRAPH FINAL part352 CVS PHARMACY AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL 59779-603_2b3a1997-f382-4843-a44b-d80d1ad21a90 59779-603 HUMAN OTC DRUG Severe Daytime acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20131227 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 59779-604_6067ee29-8aa0-4ca4-8b85-166dec9d3729 59779-604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET ORAL 20010710 ANDA ANDA072096 CVS Pharmacy IBUPROFEN 200 mg/1 59779-606_e41349c2-3144-478e-9cdf-b38ea54c22b6 59779-606 HUMAN OTC DRUG Medicated Pain dl-camphor, l-menthol, methyl salicylate PATCH TOPICAL 20011102 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 5; 4; 8 mg/1; mg/1; mg/1 59779-607_2645d291-a694-4f25-afe1-1ebec8f7d971 59779-607 HUMAN OTC DRUG Medicated Wipes Hemorrhoidal Wipes with Witch Hazel Witch Hazel CLOTH TOPICAL 20100101 OTC MONOGRAPH FINAL part346 CVS Pharmacy WITCH HAZEL .25 g/g 59779-608_4026e7b1-99ad-4de2-a65d-21e6cd8cf532 59779-608 HUMAN OTC DRUG Antibacterial Moist Wipes Benzalkonium Chloride CLOTH TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE .13 mg/mL 59779-609_5449b57f-53c9-4028-87a7-cd70c9ba88a3 59779-609 HUMAN OTC DRUG Antibacterial Moist Wipes Benzalkonium Chloride CLOTH TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE .24 mg/mL 59779-610_710a6dff-4a6b-4ff5-8bae-790c49102776 59779-610 HUMAN OTC DRUG ANTIDANDRUFF MEDICATED SELENIUM SULFIDE SHAMPOO TOPICAL 20100706 OTC MONOGRAPH FINAL part358 CVS PHARMACY INC SELENIUM SULFIDE 1 mL/100mL 59779-611_4be32790-db32-4a5f-a90b-004923f4757b 59779-611 HUMAN OTC DRUG CVS Pharmacy Dandruff Moisturizing with Aloe Selenium Sulfide SHAMPOO TOPICAL 20101015 OTC MONOGRAPH FINAL part358H CVS Pharmacy Inc SELENIUM SULFIDE 1 mL/100mL 59779-612_4ea1b167-2661-4af7-b12a-f357160f9d0e 59779-612 HUMAN OTC DRUG allergy relief Loratadine TABLET ORAL 20050104 ANDA ANDA076301 CVS Pharmacy LORATADINE 10 mg/1 59779-613_eda9987b-6e24-4b82-8189-02258e3a179c 59779-613 HUMAN OTC DRUG CVS Medicated Chest Rub Roll-On Camphor, Eucalyptus Oil, Menthol GEL TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 g/100mL; g/100mL; g/100mL 59779-614_0bbe5e2e-ca7a-4984-a3cf-51a1e6364cb3 59779-614 HUMAN OTC DRUG Dye-Free Allergy Diphenhydramine HCl TABLET ORAL 20130207 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59779-615_c44745ca-e39c-4350-ba87-c989a300e08a 59779-615 HUMAN OTC DRUG antihistamine eye Ketotifen SOLUTION OPHTHALMIC 20101019 ANDA ANDA077958 CVS Pharmacy KETOTIFEN FUMARATE .25 mg/mL 59779-616_23b9990c-18fe-4ed3-90e6-39bc0ed5821e 59779-616 HUMAN OTC DRUG stomach relief original Bismuth subsalicylate SUSPENSION ORAL 19920616 OTC MONOGRAPH FINAL part335 CVS Pharmacy BISMUTH SUBSALICYLATE 525 mg/30mL 59779-617_3044a160-2989-4311-8677-0712597fdd4b 59779-617 HUMAN OTC DRUG CVS pharmacy Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy ALCOHOL .659 mL/mL 59779-618_0debf48b-49c6-4f4d-bce8-3cb2075e63bf 59779-618 HUMAN OTC DRUG Nighttime Sleep-Aid Diphenhydramine HCl TABLET ORAL 20130507 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59779-619_9eb3d710-f1bb-443a-b3bd-5ea22990e390 59779-619 HUMAN OTC DRUG CVS PHARMACY MEDICATED SELENIUM SULFIDE LIQUID TOPICAL 20130708 OTC MONOGRAPH FINAL part358H CVS PHARMACY SELENIUM SULFIDE 10 mg/mL 59779-620_8dca210f-2446-4e8c-9071-9e9d909ee089 59779-620 HUMAN OTC DRUG CVS Extra Strength Pain Relief MENTHOL, METHYL SALICYLATE GEL TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy MENTHOL; METHYL SALICYLATE 76; 290 mg/g; mg/g 59779-621_c3d98a66-fe5d-4989-801b-31e58c563095 59779-621 HUMAN OTC DRUG CVS Medicated Anti-Itch MENTHOL, PRAMOXINE HYDROCHLORIDE CREAM TOPICAL 20100708 OTC MONOGRAPH FINAL part347 CVS Pharmacy MENTHOL; PRAMOXINE HYDROCHLORIDE 10; 10 mg/g; mg/g 59779-622_fb869713-a2be-4644-bbf2-6e894ea30fef 59779-622 HUMAN OTC DRUG CVS Capsaicin CAPSAICIN CREAM ORAL 20100708 OTC MONOGRAPH FINAL part348 CVS Pharmacy CAPSAICIN 75 mg/g 59779-623_388b1a39-daa4-425f-96e1-1c96896c8d5f 59779-623 HUMAN OTC DRUG Motion Sickness II Meclizine HCl TABLET ORAL 20131230 OTC MONOGRAPH FINAL part336 CVS Pharmacy MECLIZINE HYDROCHLORIDE 25 mg/1 59779-624_6d373e47-f918-444a-b3bb-bce99b42d502 59779-624 HUMAN OTC DRUG Kids Disappearing Color SPF50 Broad Spectrum Suncreen Pink Strawberry Scented Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20140120 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 10; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 59779-626_db104a50-6dc3-4341-82f0-d36e5a2b7f08 59779-626 HUMAN OTC DRUG Stool Softener Docusate sodium CAPSULE, GELATIN COATED ORAL 20130422 OTC MONOGRAPH NOT FINAL part334 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DOCUSATE SODIUM 100 mg/1 59779-627_9bfc8495-975d-4332-ab9f-4798dd278ea1 59779-627 HUMAN OTC DRUG Ketotifen Fumarate Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20131108 ANDA ANDA077958 CVS Pharmacy KETOTIFEN FUMARATE .35 mg/mL 59779-629_dbbd69e5-c508-4140-9b5c-4d831d082f77 59779-629 HUMAN OTC DRUG Motion Sickness Original Formula Dimenhydrinate TABLET ORAL 20140415 OTC MONOGRAPH FINAL part336 CVS Pharmacy DIMENHYDRINATE 50 mg/1 59779-630_92587e9b-8e2e-494d-8baf-0e6b44ad6b39 59779-630 HUMAN OTC DRUG CVS Pharmacy Maximum Strength Benzocaine GEL, DENTIFRICE ORAL 20130701 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 20 g/100g 59779-631_672a1f93-8b4e-4168-bc17-ea4e92e4021a 59779-631 HUMAN OTC DRUG Severe Daytime acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20131227 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 59779-632_ec3a18bc-e10d-4d4b-aea4-3da2c969ef1f 59779-632 HUMAN OTC DRUG C-Lax Laxative Bisacodyl TABLET, COATED ORAL 20050212 OTC MONOGRAPH NOT FINAL part334 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED BISACODYL 5 mg/1 59779-637_49c86b5f-7b7d-4825-8138-1d8ce4cd1d6b 59779-637 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20140718 ANDA ANDA091349 CVS Pharmacy NICOTINE 2 mg/1 59779-640_bfea1aa9-876c-4481-adc5-577931a65ab3 59779-640 HUMAN OTC DRUG Laxative Bisacodyl SUPPOSITORY RECTAL 20050608 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy BISACODYL 10 mg/1 59779-642_929b711c-2a6d-4c1f-976d-a315a01e4266 59779-642 HUMAN OTC DRUG INFANTS TEETHING LIQUID CHAMOMILLA, ARNICA MONTANA, BORAX, HYPERICUM PERFORATUM LIQUID ORAL 20140225 UNAPPROVED HOMEOPATHIC CVS PHARMACY ARNICA MONTANA; CHAMOMILE; HYPERICUM PERFORATUM; SODIUM BORATE 5; 5; 5; 5 [hp_C]/25mL; [hp_C]/25mL; [hp_C]/25mL; [hp_C]/25mL 59779-643_a120359d-4798-41c8-97c1-e7e4739882cf 59779-643 HUMAN OTC DRUG INFANTS GAS AND COLIC RELIEF COLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSA LIQUID ORAL 20140219 UNAPPROVED HOMEOPATHIC CVS PHARMACY CHAMOMILE; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA ROOT; MAGNESIUM PHOSPHATE, DIBASIC 6; 6; 6; 6 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL 59779-645_d8864e15-c85e-436d-8305-273a012c0d8f 59779-645 HUMAN OTC DRUG loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120228 ANDA ANDA091292 CVS Pharmacy LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 59779-647_e655bd64-dd82-46d8-87cc-2674beaffe20 59779-647 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 20010731 ANDA ANDA072096 CVS Pharmacy IBUPROFEN 200 mg/1 59779-648_daf3779a-0a08-4176-99c4-f7b6af8291b9 59779-648 HUMAN OTC DRUG Severe Congestion and Cough Multi-Symptom Maximum Strength Dextromethorphan, Guaifenesin, Phenylephrine TABLET ORAL 20140101 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/1; mg/1; mg/1 59779-649_770201f8-0e29-4771-bc3c-f9bb0438cba0 59779-649 HUMAN OTC DRUG CVS Sore Throat Mixed Berry Flavor BENZOCAINE, DEXTROMETHORPHAN HYDROBROMIDE LOZENGE ORAL 20140422 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc. BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 59779-650_634e9587-59e3-40ec-b1e9-bd15271c4806 59779-650 HUMAN OTC DRUG tussin adult chest congestion Guaifenesin SYRUP ORAL 19870715 OTC MONOGRAPH FINAL part341 CVS Pharmacy GUAIFENESIN 200 mg/10mL 59779-651_260b488a-b74d-41e7-8a39-cf2970360371 59779-651 HUMAN OTC DRUG Cold and Sinus Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET ORAL 20130407 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 59779-652_309b76c2-842d-4f36-af61-7cb18c64071e 59779-652 HUMAN OTC DRUG Severe Cold Relief PE Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET, FILM COATED ORAL 20050621 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 59779-656_e9401d27-7e30-4de3-b8dd-fe9f89d3e9fd 59779-656 HUMAN OTC DRUG Daytime acetaminophen, dextromethorphan hbr, phenylephrine hcl LIQUID ORAL 20060609 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 59779-660_e754d750-425d-48a7-851a-ad4e15998bb3 59779-660 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 20020904 ANDA ANDA074937 CVS Pharmacy IBUPROFEN 100 mg/5mL 59779-661_41524cba-b79a-4f94-81e5-0ad3bb843918 59779-661 HUMAN OTC DRUG CVS Pharmacy Daytime Nighttime Severe Cold and Cough Kit Acetaminophen, Diphenhydramine HCL, Phenylephrine HCL and Dextromethorphan HBr KIT 20130619 OTC MONOGRAPH FINAL part341 CVS Pharmacy 59779-664_2f975255-01b9-47b8-9059-3591d0258350 59779-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19920915 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 59779-666_f28da576-7257-4c15-b5d1-1370f96e1499 59779-666 HUMAN OTC DRUG Night Time Cough and Sore Throat Cool Blast Tylenol Cough and Sore Throat SYRUP ORAL 20090708 OTC MONOGRAPH FINAL part341 CVS ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 1000; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 59779-667_a424b3f6-ad6e-46c0-bea1-a888e02af129 59779-667 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19890715 OTC MONOGRAPH FINAL part334 CVS Pharmacy MAGNESIUM CITRATE 1.745 g/29.6mL 59779-668_846f2600-b87d-423b-b274-05870c54e06a 59779-668 HUMAN OTC DRUG nighttime cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20020923 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 59779-669_331c67d4-aab1-4b9b-a476-5f75c4393d3b 59779-669 HUMAN OTC DRUG Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140227 OTC MONOGRAPH FINAL part346 CVS Pharmacy MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g 59779-673_895cbd07-ff79-416f-a889-c881e52d39c2 59779-673 HUMAN OTC DRUG Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080805 ANDA ANDA077355 CVS Pharmacy CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 59779-678_4831166c-6863-4677-9559-b10af74b1741 59779-678 HUMAN OTC DRUG hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20121113 OTC MONOGRAPH FINAL part346 CVS Pharmacy MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/100g; mg/100g; mg/100g 59779-679_ae2f6bcc-42d1-4686-a856-5ebde2a879f9 59779-679 HUMAN OTC DRUG antibiotic and pain relief maximum strength Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20050608 OTC MONOGRAPH FINAL part333 CVS Pharmacy BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 59779-685_ddbb5104-c931-432c-bfd1-22886667b2af 59779-685 HUMAN OTC DRUG Ibuprofen Ibuprofen LIQUID ORAL 20090630 ANDA ANDA074937 CVS Pharmacy IBUPROFEN 100 mg/5mL 59779-687_f506b7cf-2fd4-44ae-ba4b-5d151582a207 59779-687 HUMAN OTC DRUG KIDS EAR RELIEF FERRUM PHOSPHORICUM, CAPSICUM ANNUUM, PYROGENIUM, ARSENICUM ALBUM, BELLADONNA LIQUID ORAL 20140130 UNAPPROVED HOMEOPATHIC CVS PHARMACY ARSENIC TRIOXIDE; ATROPA BELLADONNA; CAPSICUM ANNUUM WHOLE; FERRUM PHOSPHORICUM; RANCID BEEF 30; 30; 30; 30; 30 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL 59779-692_a5419396-9e57-4617-9bb0-9a7e557498b2 59779-692 HUMAN OTC DRUG pain relief Menthol, Methyl salicylate CREAM TOPICAL 20050608 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g 59779-698_3fac06f8-79cd-4868-a00d-74bc271f5836 59779-698 HUMAN OTC DRUG Childrens Cold and Allergy phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20060824 OTC MONOGRAPH FINAL part341 CVS Pharmacy BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 59779-699_b75cce05-76b0-4138-9dc3-18ed603fb12e 59779-699 HUMAN OTC DRUG stomach relief Bismuth subsalicylate LIQUID ORAL 19920624 OTC MONOGRAPH FINAL part335 CVS Pharmacy BISMUTH SUBSALICYLATE 1050 mg/30mL 59779-700_5f41699e-bf81-4a3b-8c34-01bea763081a 59779-700 HUMAN OTC DRUG anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030224 ANDA ANDA075232 CVS Pharmacy LOPERAMIDE HYDROCHLORIDE 2 mg/1 59779-701_515304f7-b849-4c1a-8384-ad48f9199777 59779-701 HUMAN OTC DRUG Infants Gas Relief Original Formula Dimethicone LIQUID ORAL 20130105 OTC MONOGRAPH FINAL part332 CVS DIMETHICONE 20 mg/.3mL 59779-702_1c9b339f-d6c7-4d5e-82bd-cc21b2b0779e 59779-702 HUMAN OTC DRUG Sinus and Allergy PE Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20050609 20150901 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 59779-703_468d9da4-2687-4a6f-9acd-be0caefaf441 59779-703 HUMAN OTC DRUG 12 Hour Nasal Decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19991201 ANDA ANDA075153 CVS Pharmacy PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 59779-704_c8b9d608-22a8-48f5-a20b-e330317d0c06 59779-704 HUMAN OTC DRUG Infants Gas Relief Non-Staining Formula DIMETHICONE LIQUID ORAL 20130203 OTC MONOGRAPH FINAL part332 CVS DIMETHICONE 20 mg/.3mL 59779-705_f200ea21-1527-4bed-9f12-d746a5b21927 59779-705 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140207 ANDA ANDA077958 CVS Pharmacy KETOTIFEN FUMARATE .35 mg/mL 59779-706_adc0cab4-b2dc-4ba1-a0e3-f7482c17d73e 59779-706 HUMAN OTC DRUG Womens Gentle Laxative Bisacodyl TABLET, COATED ORAL 20130401 OTC MONOGRAPH NOT FINAL part334 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED BISACODYL 5 mg/1 59779-707_9437f4c3-f9ff-4e06-ad99-c3dbbe769afb 59779-707 HUMAN OTC DRUG arthritis Trolamine Salicylate CREAM TOPICAL 19900315 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy TROLAMINE SALICYLATE 10 g/100g 59779-708_4870b2db-d349-419d-8dc3-45b8a3306c88 59779-708 HUMAN OTC DRUG Itch Relief Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20050608 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 59779-711_69bb495e-faa6-463b-bbee-5871ae997fc7 59779-711 HUMAN OTC DRUG ARNICA ARNICA MONTANA GEL TOPICAL 20140122 UNAPPROVED HOMEOPATHIC CVS PHARMACY ARNICA MONTANA 1 [hp_X]/g 59779-713_5b45fde7-ad88-4315-84db-88f27253fbe7 59779-713 HUMAN OTC DRUG CVS ANTI ITCH CAMPHOR, and MENTHOL LOTION RESPIRATORY (INHALATION) 20100708 OTC MONOGRAPH NOT FINAL part348 CVS CAMPHOR (SYNTHETIC); MENTHOL 5; 5 mg/mL; mg/mL 59779-714_391846a8-86c5-4af5-a05c-f8b7cf902352 59779-714 HUMAN OTC DRUG CVS Medicated Chest Rub Lemon Scent Cough Suppressant Topical Analgesic OINTMENT TOPICAL 20100101 OTC MONOGRAPH FINAL part341 CVS Pharmacy CAMPHOR; EUCALYPTUS OIL; MENTHOL 48; 12; 26 mg/g; mg/g; mg/g 59779-715_000e75d2-909f-48e4-a491-beefdd60594d 59779-715 HUMAN OTC DRUG CVS Medicated Chest Rub Lavender scent Cough suppressant topical analgesic OINTMENT TOPICAL 20100101 OTC MONOGRAPH FINAL part341 CVS Pharmacy Inc CAMPHOR; EUCALYPTUS OIL; MENTHOL 48; 12; 26 mg/g; mg/g; mg/g 59779-716_23c32084-4312-4494-8e64-f7f210126463 59779-716 HUMAN OTC DRUG CVS Medicated Chest Rub Cherry Scent cough suppressant topical analgesic OINTMENT TOPICAL 20100101 OTC MONOGRAPH FINAL part341 CVS Pharmacy Inc CAMPHOR; EUCALYPTUS OIL; MENTHOL 48; 12; 26 mg/g; mg/g; mg/g 59779-717_e3aac781-4648-4350-b0d5-33309d6519cb 59779-717 HUMAN OTC DRUG CAMPHOR, EUCALYPTUS OIL and MENTHOL CAMPHOR, EUCALYPTUS OIL and MENTHOL OINTMENT RESPIRATORY (INHALATION) 20090519 OTC MONOGRAPH NOT FINAL part348 CVS CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 52; 12; 28 mg/mL; mg/mL; mg/mL 59779-719_6303d97d-d604-492d-9b88-bb9dea03a1fd 59779-719 HUMAN OTC DRUG CVS PHARMACY MAXIMUM STRENGTH DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20141117 OTC MONOGRAPH FINAL part358H CVS PHARMACY SELENIUM SULFIDE 10 mg/mL 59779-720_7f008029-0e77-480e-967f-dbd03bf4b74b 59779-720 HUMAN OTC DRUG ANTIBACTERIAL HSOAP FRESH AND LIGHT SCENT - REFILL TRICLOSAN LIQUID TOPICAL 20110318 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .115 L/100L 59779-720_ddcc7676-95fa-4a00-b13d-2b337737f88f 59779-720 HUMAN OTC DRUG ANTIBACTERIAL HSOAP FRESH AND LIGHT SCENT - REFILL TRICLOSAN LIQUID TOPICAL 20110203 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .115 L/100L 59779-723_a489694d-4e2e-4474-8ae8-c57b94805d1c 59779-723 HUMAN OTC DRUG CVS PHARMACY FRESH WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL 59779-723_ac349e8c-fc33-4637-90bc-15487e3650d2 59779-723 HUMAN OTC DRUG CVS PHARMACY FRESH WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140507 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL 59779-724_811ec036-7823-4e50-8f15-3e4c0261b8f0 59779-724 HUMAN OTC DRUG CVS PHARMACY CITRUS FRESH BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131231 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL 59779-725_1ca2c406-0c2d-416e-aada-d48e091ba985 59779-725 HUMAN OTC DRUG CVS PHARMACY CITRUS FRESH BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140113 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL 59779-726_143a8778-4029-48d9-82fb-8d70e2a4efe4 59779-726 HUMAN OTC DRUG ALLERGY RELIEF-D Loratadine and Pseudoephedrine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140207 ANDA ANDA076557 CVS Pharmacy LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 59779-729_9da64de1-e78b-4537-b7bb-84d1030409fa 59779-729 HUMAN OTC DRUG CVS Cools Itch Fast Hydrocortisone GEL TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. HYDROCORTISONE 1 mg/g 59779-730_98ff42e7-f2fb-45d3-b7d8-5d85d8cdb6c4 59779-730 HUMAN OTC DRUG Miconazole 7 Miconazole nitrate CREAM VAGINAL 20090915 ANDA ANDA074164 CVS MICONAZOLE NITRATE 2 g/100g 59779-731_5ac22bb2-4720-4d6e-a8c9-51878fbdaab8 59779-731 HUMAN OTC DRUG CVS Redness Relief Maximum Dextran 70 Polyethylene glycol 400 Povidone Tetrahydrozoline HCI SOLUTION/ DROPS OPHTHALMIC 20140306 OTC MONOGRAPH FINAL part349 CVS Pharmacy, Inc. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .001; .01; .01; .0005 mg/mL; mg/mL; mg/mL; mg/mL 59779-734_286b7d57-9451-49c0-a3f8-abcebdd03d79 59779-734 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20130213 ANDA ANDA203690 CVS Pharmacy NICOTINE 2 mg/1 59779-736_96d9d811-f7f3-46b5-92d6-8f0aa2de6454 59779-736 HUMAN OTC DRUG pain relief Acetaminophen CAPSULE, COATED ORAL 20110507 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 59779-737_f95a339c-88ed-4686-b552-03a32206083b 59779-737 HUMAN OTC DRUG Miconazole 1 Miconazole nitrate KIT 20100608 ANDA ANDA079114 CVS Pharmacy 59779-741_b2d0e9a8-89bc-470f-a343-480b1dc637ef 59779-741 HUMAN OTC DRUG CVS Redness Relief Original Tetrahydrozoline hydrochloride SOLUTION/ DROPS OPHTHALMIC 20140306 OTC MONOGRAPH FINAL part349 CVS Pharmacy, Inc. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 59779-742_e2f919be-49b9-48ae-bcee-d914fbe3e651 59779-742 HUMAN OTC DRUG naproxen sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20101123 NDA NDA021920 CVS Pharmacy NAPROXEN SODIUM 220 mg/1 59779-744_6f7ded3a-2cde-4b27-aa28-b33777dcdbb9 59779-744 HUMAN OTC DRUG CVS PHARMACY HAND SANITIZER ALOE ETHYL ALCOHOL LIQUID TOPICAL 20141117 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL 59779-744_e4657641-e67d-48df-a3f5-b0ce79553f23 59779-744 HUMAN OTC DRUG CVS PHARMACY HAND SANITIZER ALOE ETHYL ALCOHOL LIQUID TOPICAL 20141117 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL 59779-750_076dec99-8338-414f-b4c3-5f3783565248 59779-750 HUMAN OTC DRUG Tolnaftate Antifungal Powder Spray AEROSOL, POWDER TOPICAL 20140104 OTC MONOGRAPH FINAL part333C CVS Pharmacy TOLNAFTATE 1.3 g/130g 59779-751_6e7ea0f7-1382-4097-9777-d71e60162fb0 59779-751 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN 500 mg/1 59779-752_ea235d7c-40cc-47ce-8e92-3f1acb0e4d03 59779-752 HUMAN OTC DRUG CVS Hemorrhoidal Glycerin Phenylephrine HCI Pramoxine HCI White Petrolatum CREAM TOPICAL 20140117 OTC MONOGRAPH FINAL part346 CVS Pharmacy, Inc. GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g 59779-754_457552b5-8943-45d1-911c-5f07b823cff6 59779-754 HUMAN OTC DRUG childrens pain and fever Acetaminophen SUSPENSION ORAL 20090715 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL 59779-758_1c0f455a-a52e-4762-baf7-a3ac741e08f9 59779-758 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride SUSPENSION ORAL 20140204 ANDA ANDA091292 CVS Pharmacy LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 59779-759_d52a2585-eb05-452b-9ca1-6c315d8ef9fc 59779-759 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen SUSPENSION ORAL 20090715 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL 59779-761_93e8184a-6a11-491b-9901-d5c1cde1520c 59779-761 HUMAN OTC DRUG Severe Cold and Congestion Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET ORAL 20130407 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 59779-763_d40d6fd1-3f84-40ae-ab7e-04569eb41617 59779-763 HUMAN OTC DRUG Severe Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl LIQUID ORAL 20131227 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 59779-766_868a5450-d51b-4871-b56d-b1964d502f53 59779-766 HUMAN OTC DRUG pain relief Acetaminophen TABLET ORAL 19910615 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 325 mg/1 59779-770_c34dee09-f23a-46bf-8b7a-68c22103aaaa 59779-770 HUMAN OTC DRUG CVS Medicated Heat 1 ct Capsaicin PATCH TOPICAL 20140916 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. CAPSAICIN .025 g/g 59779-779_33693865-d51c-4b76-aa90-d16928168b72 59779-779 HUMAN OTC DRUG SINUS PAIN AND CONGESTION Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20050726 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED 59779-794_e86ecdc8-689d-4fc8-b63a-eebbedcc579b 59779-794 HUMAN OTC DRUG CHILDRENS ALLERGY RELIEF Fexofenadine Hydrochloride SUSPENSION ORAL 20141219 ANDA ANDA203330 CVS Pharmacy FEXOFENADINE HYDROCHLORIDE 30 mg/5mL 59779-796_bef4f237-ccb8-4d28-bfc2-41c511a17d7f 59779-796 HUMAN OTC DRUG No Drip Nasal Mist Original oxymetazoline hydrochloride SPRAY NASAL 20120901 OTC MONOGRAPH FINAL part341 CVS Pharmacy OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 59779-798_8a80e784-3ebc-4fe0-a635-478aa1c959b4 59779-798 HUMAN OTC DRUG Hair regrowth treatment for men Minoxidil SOLUTION TOPICAL 20100105 ANDA ANDA075598 CVS Pharmacy MINOXIDIL 3 g/60mL 59779-799_7984e5e8-33f6-4ea1-9937-5a85320c2221 59779-799 HUMAN OTC DRUG Non Drowsy Cold and Cough PE Acetaminophen, Dextromathorphan HBr, Gauifenesin, Phenylephrine HCl CAPSULE, COATED ORAL 20070222 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 59779-800_54e612a6-1f0e-418f-bf1c-4de8ba0f931a 59779-800 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20130725 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 59779-801_3e903155-ab86-439a-8c32-9d44238c9e2c 59779-801 HUMAN OTC DRUG CVS PHARMACY TRICLOSAN LIQUID TOPICAL 20130404 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN 1.5 mg/mL 59779-803_cc865016-4954-47e9-ba51-071c8e804116 59779-803 HUMAN OTC DRUG nighttime cold flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140221 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 59779-804_050b41b2-3061-4dd7-b6a4-f751155b34b1 59779-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19920715 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc ISOPROPYL ALCOHOL .91 mg/mL 59779-805_9b5ba347-49e9-42c1-8f83-d171cb1b6f6d 59779-805 HUMAN OTC DRUG Antibacterial Body Wash Triclosan LIQUID TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy TRICLOSAN .15 mL/100mL 59779-806_ed2229b7-5bcf-49e2-8be9-ae7299139371 59779-806 HUMAN OTC DRUG VIPER ACNE BODY WASH SALICYLIC ACID LIQUID TOPICAL 20110318 OTC MONOGRAPH FINAL part333D CVS PHARMACY SALICYLIC ACID 2 mL/100mL 59779-807_48732d5b-70ac-41cd-86b4-ea45d7ec9c54 59779-807 HUMAN OTC DRUG CVS Triple Action Astringent SALICYLIC ACID LIQUID TOPICAL 20100708 OTC MONOGRAPH FINAL part333D CVS Pharmacy SALICYLIC ACID 20.5 mg/mL 59779-807_ba9d81bd-e62c-4863-a424-33f26e96319d 59779-807 HUMAN OTC DRUG CVS Triple Action Astringent SALICYLIC ACID LIQUID TOPICAL 20100708 OTC MONOGRAPH FINAL part333D CVS Pharmacy SALICYLIC ACID 20.5 mg/mL 59779-808_5dfd80ed-b2d1-4a16-a11c-a72bde930168 59779-808 HUMAN OTC DRUG CVS Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy ISOPROPYL ALCOHOL 70 mL/100mL 59779-809_78d8affe-873a-4d8f-8309-c093ed533d86 59779-809 HUMAN OTC DRUG Antibiotic and pain relief maximum strength Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20050608 OTC MONOGRAPH FINAL part333B CVS Pharmacy NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 59779-810_fa434f3c-a4ea-4745-8206-abaeff14054d 59779-810 HUMAN OTC DRUG BENZOCAINE and RESORCINOL BENZOCAINE and RESORCINOL CREAM TOPICAL 20090519 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy BENZOCAINE; RESORCINOL 200; 20 mg/g; mg/g 59779-811_c1066802-f7b3-4ed4-8669-7ce60d90838a 59779-811 HUMAN OTC DRUG CVS Deep Cleansing Astringent SALICYLIC ACID LIQUID TOPICAL 20100708 OTC MONOGRAPH FINAL part333D CVS Pharmacy SALICYLIC ACID 5 mg/mL 59779-812_3564ecc2-9d0b-45a3-8840-811950047255 59779-812 HUMAN OTC DRUG CVS Pore Unclogging Scrub SALICYLIC ACID SOAP TOPICAL 20100708 OTC MONOGRAPH FINAL part333D CVS Pharmacy SALICYLIC ACID 20 mg/g 59779-813_309dfa96-35c0-4c59-ae92-ba543c3dd666 59779-813 HUMAN OTC DRUG CVS ACNE TREATMENT RESORCINOL, SULFUR CREAM TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part333D CVS Pharmacy RESORCINOL; SULFUR 20; 80 mg/g; mg/g 59779-814_4ba4ccf6-fc46-4053-a060-fe18b5fbe228 59779-814 HUMAN OTC DRUG Sensitive Whitening Enamel Guard Fluoride and Potassium Nitrate GEL DENTAL 20111213 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy POTASSIUM NITRATE; SODIUM FLUORIDE 5; .15 g/100g; g/100g 59779-815_dcd32a69-20e3-4016-ba99-50ed18b15de5 59779-815 HUMAN OTC DRUG CVS Pharmacy Enamel Guard Fluoride PASTE, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part355 CVS Pharmacy POTASSIUM NITRITE; SODIUM FLUORIDE 5; .15 g/100g; g/100g 59779-816_247bcabe-a146-4a58-9251-7ee703dceb27 59779-816 HUMAN OTC DRUG Sensitive Tooth Paste Whitening Fluoride GEL DENTAL 20111213 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy POTASSIUM NITRATE; SODIUM FLUORIDE 5; .15 g/100g; g/100g 59779-817_16898559-ee2a-47cb-858b-01e571bcf90c 59779-817 HUMAN OTC DRUG nasal sinus oxymetazoline hydrochloride SPRAY NASAL 19991005 OTC MONOGRAPH FINAL part341 CVS Pharmacy OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 59779-818_e58a4bfe-2c71-4655-b026-08b9dfe724ee 59779-818 HUMAN OTC DRUG CVS Scalp Relief Salicylic Acid LIQUID TOPICAL 20140601 OTC MONOGRAPH FINAL part358H CVS Pharmacy SALICYLIC ACID 3 g/100mL 59779-819_1029facf-4f3e-4089-b384-0edcccbefb71 59779-819 HUMAN OTC DRUG Sensitive Tooth Paste Multi Action Fluoride GEL DENTAL 20111213 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy POTASSIUM NITRATE; SODIUM FLUORIDE 5; .15 g/100g; g/100g 59779-820_f3d0f9e6-fa23-4944-aef0-43dfcacfc1b0 59779-820 HUMAN OTC DRUG Severe Oral Pain Reliever Benzocaine LIQUID ORAL 20111227 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 20 g/100g 59779-821_654e7ef3-27f3-42d5-831e-e88d32996368 59779-821 HUMAN OTC DRUG CVS Cold Hot Medicated Menthol PATCH TOPICAL 20131014 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy Inc. MENTHOL .05 g/g 59779-822_76240585-3e85-4a17-acfd-f2c1cc7ffb66 59779-822 HUMAN OTC DRUG Antibiotic and Pain Relief Maximum Strength Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part347 CVS Pharmacy NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g 59779-823_f8c77e87-54f5-41c8-bc0a-54b2254669d0 59779-823 HUMAN OTC DRUG Triple Antibiotic and Pain Relief Maximum Strength bacitracin zinc, neomycin sulfate, polymyxin b sulfate and pramoxine hydrochloride OINTMENT TOPICAL 20050103 OTC MONOGRAPH FINAL part333B CVS Pharmacy BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 59779-824_79669d9b-6a2a-4789-84e6-d5d6ede280f2 59779-824 HUMAN OTC DRUG Aspirin-Free Tension Headache Acetaminophen, Caffeine CAPSULE ORAL 20070117 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 59779-826_779648c8-ab59-4dd6-b317-b5f69e6657ff 59779-826 HUMAN OTC DRUG Therapeutic Plus Coal Tar SHAMPOO TOPICAL 20020524 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc COAL TAR 25 mg/mL 59779-827_a40da787-5a56-4ae5-8a62-f2091a89a38f 59779-827 HUMAN OTC DRUG Diaper Rash Dimethicone, Zinc Oxide CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 CVS Pharmacy DIMETHICONE; ZINC OXIDE 1; 10 g/100g; g/100g 59779-828_5e87f48c-4f08-4b81-af36-e482946b1b71 59779-828 HUMAN OTC DRUG congestion relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20140919 ANDA ANDA203200 CVS Pharmacy IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 59779-829_4b601522-3099-4501-90aa-093c4645c25a 59779-829 HUMAN OTC DRUG CVS Fast Acting Baby Teething BENZOCAINE GEL ORAL 20100708 OTC MONOGRAPH FINAL part346 CVS Pharmacy BENZOCAINE 75 mg/g 59779-829_e0ba65c6-5dc4-4b1c-95f4-a3b815fc5c14 59779-829 HUMAN OTC DRUG CVS Fast Acting Baby Teething BENZOCAINE GEL ORAL 20100708 OTC MONOGRAPH FINAL part346 CVS Pharmacy BENZOCAINE 75 mg/g 59779-830_b8178aba-50dd-4fbb-8352-bdb6ea2980ef 59779-830 HUMAN OTC DRUG Mouth Sore Relief Professional Strength Benzocaine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 200 mg/g 59779-831_f259b98b-c4bc-4ba9-bbbf-131ce491b81b 59779-831 HUMAN OTC DRUG Instant Toothache Pain Relief Benzocaine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 20 g/100g 59779-832_f5b5ac73-4a30-467f-b208-76f4dad9a6af 59779-832 HUMAN OTC DRUG CVS Pharmacy Restore and Defend Fluoride PASTE, DENTIFRICE DENTAL 20140701 OTC MONOGRAPH FINAL part355 CVS Pharmacy STANNOUS FLUORIDE .15 g/100g 59779-833_1eaadd8b-b6c6-4625-858c-6304265fcdee 59779-833 HUMAN OTC DRUG CVS Pharmacy Nighttime Oral Pain Relief Benzocaine GEL, DENTIFRICE DENTAL 20130801 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 10 g/100g 59779-836_4a8a7abe-4036-45dd-8486-25be34527937 59779-836 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20131206 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc PYRITHIONE ZINC 10.3 mg/mL 59779-839_a0106a23-ad5f-4084-aea6-16e2700bec51 59779-839 HUMAN OTC DRUG Miconazole 3 Miconazole nitrate KIT 20140228 ANDA ANDA076357 CVS Pharmacy 59779-840_f970dadf-5c83-4857-bd03-e4427ff26600 59779-840 HUMAN OTC DRUG CVS Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 59779-842_065e258f-dc10-4b53-a078-9ac6eaaf30c3 59779-842 HUMAN OTC DRUG CVS PHARMACY COCONUT WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140120 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL 59779-842_36a44418-1c8d-4b42-a176-2b374fdc9000 59779-842 HUMAN OTC DRUG CVS PHARMACY COCONUT WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140126 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL 59779-843_96ad69be-a2f4-41b1-a7ce-96585c785b76 59779-843 HUMAN OTC DRUG cooling hemorrhoidal Phenylephrine HCl, Witch hazel GEL TOPICAL 20050609 OTC MONOGRAPH FINAL part346 CVS Pharmacy PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/100g; g/100g 59779-844_dc536fd6-9a9e-4e23-b7b3-e302a8634301 59779-844 HUMAN OTC DRUG CVS Anti-Itch Hydrocortisone Hydrocortisone CREAM TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. HYDROCORTISONE 1 mg/g 59779-846_8d2c838d-23ec-4429-8311-f4d71ea8f9d3 59779-846 HUMAN OTC DRUG DIARRHEA CINCHONA OFFICINALIS, BRYONIA, CHAMOMILLA, COLOCYNTHIS, IPECACUANHA, BELLADONNA TABLET, CHEWABLE ORAL 20140429 UNAPPROVED HOMEOPATHIC CVS PHARMACY ATROPA BELLADONNA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; MATRICARIA RECUTITA 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 59779-847_ec082769-c688-4aca-9685-5c521a0a5856 59779-847 HUMAN OTC DRUG INDIGESTION LYCOPODIUM CLAVATUM, CARDUUS MARIANUS, CHELIDONIUM MAJUS, BOLDO, NUX VOMICA TABLET, CHEWABLE ORAL 20140522 UNAPPROVED HOMEOPATHIC CVS PHARMACY CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; PEUMUS BOLDUS LEAF; SILYBUM MARIANUM SEED; STRYCHNOS NUX-VOMICA SEED 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 59779-851_b306162f-7555-488c-8416-56ad7f5ab387 59779-851 HUMAN OTC DRUG antacid liquid regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20021209 OTC MONOGRAPH FINAL part332 CVS Pharmacy ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 59779-854_f1feac96-2f36-4826-9ecc-c04ec8bf6155 59779-854 HUMAN OTC DRUG nicotine Nicotine polacrilex GUM, CHEWING ORAL 20070915 ANDA ANDA078546 CVS Pharmacy NICOTINE 4 mg/1 59779-855_a006b800-f262-4fd9-8b1a-48512c57e263 59779-855 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130105 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 59779-856_648d0673-9df6-4867-984f-103ba2ed51c6 59779-856 HUMAN OTC DRUG HAIR REGROWTH TREATMENT FOR WOMEN Minoxidil SOLUTION TOPICAL 20060908 ANDA ANDA075357 CVS Pharmacy MINOXIDIL 2 g/100mL 59779-857_ff812bb6-e48b-46bc-9477-f8b691198a3a 59779-857 HUMAN OTC DRUG Constipation Relief Alumina, Bryonia, Graphites, Natrum Muriaticum, Silicea LIQUID ORAL 20141030 UNAPPROVED HOMEOPATHIC WOONSOCKET PRESCR CTR INC ALUMINUM OXIDE; BRYONIA ALBA ROOT; GRAPHITE; SILICON DIOXIDE; SODIUM CHLORIDE 8; 8; 8; 8; 8 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 59779-858_06f026c2-80db-4716-8420-670933b0c8b3 59779-858 HUMAN OTC DRUG Gallbladder Relief Belladonna, Carduus Marianus, Chelidonium Majus, Colocynthis, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vornica, Phosphorus, Pulsatilla, Veratrum Album TABLET ORAL 20141111 UNAPPROVED HOMEOPATHIC WOONSOCKET PRESCR CTR INC ATROPA BELLADONNA; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; PHOSPHORUS; PULSATILLA VULGARIS; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601 59779-860_fb2fef3e-1ef9-46e2-a83a-c043a625405c 59779-860 HUMAN OTC DRUG INFANTS TEETHING CHAMOMILLA, CALCAREA PHOSPHORICA, COFFEA CRUDA, BELLADONNA TABLET, ORALLY DISINTEGRATING ORAL 20140214 UNAPPROVED HOMEOPATHIC CVS PHARMACY ATROPA BELLADONNA WHOLE; CALCIUM PHOSPHATE; CHAMOMILE; COFFEA ARABICA FRUIT 12; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 59779-863_5afc936e-6def-4a53-aae8-b8a2022fc4e4 59779-863 HUMAN OTC DRUG Nighttime Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DOXYLAMINE SUCCINATE 25 mg/1 59779-866_bd7f2daf-23e3-4209-bdd7-89782306f269 59779-866 HUMAN OTC DRUG lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070713 OTC MONOGRAPH NOT FINAL part358G CVS Pharmacy PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL 59779-871_d4697d27-6458-4bd6-a78d-3341c80b34b7 59779-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 19920715 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc HYDROGEN PEROXIDE 30 mg/mL 59779-873_cb41bbc8-6475-47ca-b10d-17f043e34dab 59779-873 HUMAN OTC DRUG nicotine Nicotine polacrilex LOZENGE ORAL 20060222 ANDA ANDA077007 CVS Pharmacy NICOTINE 4 mg/1 59779-878_c766deac-d993-4e48-a5c3-4cfde7338dff 59779-878 HUMAN OTC DRUG cortisone Hydrocortisone LOTION TOPICAL 20120410 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy HYDROCORTISONE 1 g/100g 59779-882_7dc50a2b-2bd3-4c4e-8306-f172d11b4add 59779-882 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20140209 ANDA ANDA074937 CVS Pharmacy IBUPROFEN 100 mg/5mL 59779-884_5712e1d7-1565-4866-beef-298703b359bf 59779-884 HUMAN OTC DRUG Allergy Relief Childrens cetirizine Hydrochloride LIQUID ORAL 20100818 ANDA ANDA090254 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 5 mg/5mL 59779-885_1252e0a2-acad-4eb2-9f9d-9190179d5192 59779-885 HUMAN OTC DRUG Cortisone maximum strength Hydrocortisone GEL TOPICAL 20091222 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy HYDROCORTISONE 1 g/100g 59779-887_763af79d-f6bb-4879-8722-4e213b1cedf1 59779-887 HUMAN OTC DRUG clear laxative Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20100302 ANDA ANDA090685 CVS Pharmacy POLYETHYLENE GLYCOL 3350 17 g/17g 59779-888_df5d4487-9d47-4636-971f-3fa1c5376dcf 59779-888 HUMAN OTC DRUG CVS PHARMACY JUICY PEAR BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140126 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL 59779-889_7fbf01c6-01e3-4ae5-b9db-934e2e289e84 59779-889 HUMAN OTC DRUG SEVERE COLD AND FLU RELIEF Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guiafenesin TABLET, FILM COATED ORAL 20050804 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 59779-891_4af066f8-4f1d-4105-a782-b19653a3fbcc 59779-891 HUMAN OTC DRUG cold and sinus relief Ibuprofen, Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011009 ANDA ANDA074567 CVS Pharmacy IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 59779-897_cdfee742-5549-4d87-828f-389db6290fc6 59779-897 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990107 ANDA ANDA074937 CVS Pharmacy IBUPROFEN 100 mg/5mL 59779-899_dd82a811-9d34-4e8f-8564-19546fa05e0e 59779-899 HUMAN OTC DRUG CVS Pharmacy Reflective White Fluoride PASTE, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part355 CVS Pharmacy SODIUM MONOFLUOROPHOSPHATE .76 g/100g 59779-900_805c7ea8-7448-43ff-9feb-1ce985d469dc 59779-900 HUMAN OTC DRUG Ear Pain Relief Ear Drops Chamomilla and Mercurius solubilis and Sulphur SOLUTION AURICULAR (OTIC) 20071001 UNAPPROVED HOMEOPATHIC Woonsocket Prescription Center (CVS) CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR 10; 15; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 59779-901_73605039-fd7c-4a23-9a93-1c1b9e12507e 59779-901 HUMAN OTC DRUG Pink Eye Relief Belladonna and Euphrasia and Hepar sulphuris SOLUTION/ DROPS OPHTHALMIC 20071001 UNAPPROVED HOMEOPATHIC Woonsocket Prescription Center (CVS) ATROPA BELLADONNA; CALCIUM SULFIDE; EUPHRASIA STRICTA 6; 12; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 59779-902_34b396bd-bb72-44e9-bb54-d4880c8f522f 59779-902 HUMAN OTC DRUG pure petroleum White petrolatum JELLY TOPICAL 20050614 OTC MONOGRAPH FINAL part347 CVS Pharmacy PETROLATUM 100 g/100g 59779-903_bf732f63-a561-4e18-8a9c-d99553b92354 59779-903 HUMAN OTC DRUG multi symptom cold relief childrens Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20090311 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 59779-904_e076a12b-0aea-47fd-9d91-9bfdeeea4533 59779-904 HUMAN OTC DRUG CVS Advanced Healing Petrolatum OINTMENT TOPICAL 20110212 OTC MONOGRAPH FINAL part347 CVS PETROLATUM 410 mg/g 59779-906_afc534ca-1e2a-475d-8fad-e494ab051e15 59779-906 HUMAN OTC DRUG DiBromm with PE Dimetapp LIQUID ORAL 20090716 OTC MONOGRAPH FINAL part341 CVS BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 59779-908_3a1437ef-3a9e-4c90-8504-098fa768f8e3 59779-908 HUMAN OTC DRUG NIGHTTIME Multi Symptom acetaminophen, dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20060609 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 59779-909_c97d0581-491b-4b94-b45b-0fa6aafbad6c 59779-909 HUMAN OTC DRUG All Day Moisture Octinoxate, Zinc Oxide LOTION TOPICAL 20050715 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTINOXATE; ZINC OXIDE 61.2; 30.6 mg/mL; mg/mL 59779-912_bccc4417-58a8-40e8-88c6-cfb36425f504 59779-912 HUMAN OTC DRUG Daytime Nighttime Multi Symptom Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20060802 OTC MONOGRAPH FINAL part341 CVS Pharmacy 59779-912_ef95ae5c-d190-4884-95b7-c22d5ec2cdd2 59779-912 HUMAN OTC DRUG Daytime Nighttime Multi Symptom Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20060802 OTC MONOGRAPH FINAL part341 CVS Pharmacy 59779-913_de38b65d-5091-47e8-b160-76b398f9998f 59779-913 HUMAN OTC DRUG CVS Pharmacy Mouth Sore Gel Benzocaine GEL, DENTIFRICE ORAL 20121001 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZALKONIUM CHLORIDE; BENZOCAINE; ZINC CHLORIDE .02; 20; .1 g/100g; g/100g; g/100g 59779-915_fbfb723d-1ab0-478b-9e68-e66d9b8234cd 59779-915 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 59779-917_15b56a8c-1cf5-4505-b7a5-d008cdbdce13 59779-917 HUMAN OTC DRUG pain relief extra strength Acetaminophen CAPSULE, COATED ORAL 20110317 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 59779-918_c85fe450-3daa-4d93-8797-47122607de87 59779-918 HUMAN OTC DRUG Nicotine Polacrilex Nicotine polacrilex GUM, CHEWING ORAL 20140718 ANDA ANDA091354 CVS Pharmacy NICOTINE 4 mg/1 59779-919_5bdc3f30-9b47-45ad-a126-b61c1a3bf138 59779-919 HUMAN OTC DRUG tussin dm Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19941207 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 59779-920_bea31fa2-14a4-4ec1-993f-e8ab377956d6 59779-920 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140207 ANDA ANDA077958 CVS Pharmacy KETOTIFEN FUMARATE .35 mg/mL 59779-922_7abc66f2-faf6-421c-9c3c-b69f5a587246 59779-922 HUMAN OTC DRUG CVS Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20131016 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy ISOPROPYL ALCOHOL 70 mL/100mL 59779-923_d42a7149-f767-4b68-9547-4bc735b98ba4 59779-923 HUMAN OTC DRUG Allergy Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59779-930_4ea4b4ef-b539-44ae-a6f0-743dc905be62 59779-930 HUMAN OTC DRUG Menstrual Relief Acetaminophen caffeine pyrilamine maleate CAPSULE ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 59779-931_c21acb63-ef79-4eef-8695-8a476611f54d 59779-931 HUMAN OTC DRUG CVS Pharmacy Instant Toothache Benzocaine GEL, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 20 g/100g 59779-932_bc50832e-f9ea-4a25-b7cf-7b4b83851122 59779-932 HUMAN OTC DRUG BestHealth Menthol MENTHOL LOZENGE ORAL 20130115 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 7 mg/1 59779-936_3f2b8ec0-2a19-4e09-acca-27aa81fe3a58 59779-936 HUMAN OTC DRUG Maximum Strength PMS Formula Acetaminophen, Pamabrom and Pyrilamine maleate CAPSULE, COATED ORAL 20000620 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 59779-939_a4eac37b-e135-4bd8-aa49-998f87caec64 59779-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 10 mg/1 59779-940_caa42f4d-998c-45da-9e5c-11f00f45ff67 59779-940 HUMAN OTC DRUG Mens Hair Regrowth Treatment extra strength Minoxidil SOLUTION TOPICAL 20000801 ANDA ANDA075518 CVS Pharmacy MINOXIDIL 50 mg/mL 59779-942_7c2f8c52-1673-48c1-aa83-da5755b35deb 59779-942 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130913 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 59779-943_5b177115-9f0c-48a4-9fea-1f547436a2c9 59779-943 HUMAN OTC DRUG Kids Disappearing Color SPF50 Broad Spectrum Suncreen Green Apple Scented Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20140120 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; 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GUAIFENESIN 10; 200 mg/5mL; mg/5mL 59779-969_47ffb719-ad13-4530-b1a0-c419c801913a 59779-969 HUMAN OTC DRUG CVS Pharmacy Saline Laxative ENEMA RECTAL 20140520 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 3.5; 9.5 g/59mL; g/59mL 59779-970_f1ba6fa0-9369-4137-a2f0-d5a207ec8257 59779-970 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20040408 OTC MONOGRAPH FINAL part336 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 59779-971_f564d239-f394-4607-8e55-895bb8e3ce09 59779-971 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20140129 ANDA ANDA074937 CVS Pharmacy IBUPROFEN 100 mg/5mL 59779-974_d3733bfc-5ccb-4fb4-9497-bc49e7174005 59779-974 HUMAN OTC DRUG Childrens Allergy Relief cetirizine hydrochloride LIQUID ORAL 20090715 ANDA ANDA090254 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 5 mg/5mL 59779-975_9c90c612-e237-4e94-928b-6b730a1d7246 59779-975 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET ORAL 19930806 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 59779-976_f6524c77-db5c-4fe0-89b8-436eafdb4c95 59779-976 HUMAN OTC DRUG allergy relief Diphenhydramine hydrochloride TABLET, FILM COATED ORAL 20141121 OTC MONOGRAPH FINAL part341 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59779-977_76e69c94-b9fa-45c3-a7f4-6bbef0091191 59779-977 HUMAN OTC DRUG Nighttime multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20060601 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 59779-980_c0c96821-97e3-4d34-87f5-cb3dca80ab21 59779-980 HUMAN OTC DRUG Pain Relief infants Acetaminophen SUSPENSION/ DROPS ORAL 20100825 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 80 mg/.8mL 59779-981_86a525ae-1d37-4ccb-a474-771dedc6c411 59779-981 HUMAN OTC DRUG CVS COLD AND HOT MEDICATED XL MENTHOL PATCH TOPICAL 20101111 OTC MONOGRAPH NOT FINAL part348 CVS PHARMACY, INC. MENTHOL 750 mg/1 59779-982_5551bfea-ac81-4745-a2a3-3bc99347aeb1 59779-982 HUMAN OTC DRUG eye itch relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20100914 ANDA ANDA077958 CVS Pharmacy KETOTIFEN FUMARATE .25 g/mL 59779-983_549a0c17-87e5-411c-8664-0b705b22776c 59779-983 HUMAN OTC DRUG CVS Homeopathic SKIN TAG REMOVER THUJA OCCIDENTALIS LEAFY TWIG LIQUID TOPICAL 20140625 UNAPPROVED HOMEOPATHIC CVS Pharmacy, Inc THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/10mL 59779-987_75926ad0-9a1b-421e-b886-faf8cb2e11c9 59779-987 HUMAN OTC DRUG DiBromm DM BROMPHENIRAMINE MALEATE , PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, LIQUID ORAL 20090716 OTC MONOGRAPH FINAL part341 Aaron Industries, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 59779-988_cf89e4cf-a94f-4d4b-b109-b1dc9a5138b1 59779-988 HUMAN OTC DRUG CVS Pharmacy Rash Cream Zinc oxide, Petrolatum CREAM TOPICAL 20140520 OTC MONOGRAPH FINAL part346 CVS Pharmacy PETROLATUM; ZINC OXIDE 67; 13 mg/mL; mg/mL 59779-989_bb9b0056-dd3e-453d-9eb3-2bd870ea1469 59779-989 HUMAN OTC DRUG CVS Pharmacy Intensive Moisturizing Cream Dimethicone CREAM TOPICAL 20140520 OTC MONOGRAPH FINAL part347 CVS Pharmacy DIMETHICONE 12.5 mg/mL 59779-990_ff03992a-4a49-4361-a481-fd0f5184c425 59779-990 HUMAN OTC DRUG Bisacody Enteric Coated Bisacodyl TABLET, COATED ORAL 20130110 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy BISACODYL 5 mg/1 59779-991_bcbfe1f1-6e96-4f45-bd96-79a84b94e193 59779-991 HUMAN OTC DRUG PAIN RELIEVING PATCH ULTRA STRENGTH ULTRA STRENGTH MENTHOL PATCH TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part348 CVS PHARMACY, INC. MENTHOL 50 mg/g 59779-992_03850618-92e2-47f6-9c93-08561e178bfe 59779-992 HUMAN OTC DRUG Dye-Free Wal-Dryl Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20010913 OTC MONOGRAPH FINAL part336 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59779-993_dd00c96d-5987-4680-a49b-d12919dfd009 59779-993 HUMAN OTC DRUG CVS Pharmacy Maximum Strength Feminine Wipes Pramoxine Hydrochloride CLOTH TOPICAL 20130321 OTC MONOGRAPH FINAL part346 CVS Pharmacy PRAMOXINE HYDROCHLORIDE 10 mg/g 59779-994_cf02bfab-49ed-49f1-83d3-aff0317ca924 59779-994 HUMAN OTC DRUG daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20060609 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 59779-995_fc06a689-bb56-48c8-84d8-c8df70a4ad5b 59779-995 HUMAN OTC DRUG infants ibuprofen ibuprofen SUSPENSION ORAL 19991108 ANDA ANDA075217 CVS Pharmacy IBUPROFEN 50 mg/1.25mL 59779-996_3358663e-728e-4a6f-9443-14684c6db5dc 59779-996 HUMAN OTC DRUG Mineral Oil Lubricant Laxative mineral oil ENEMA RECTAL 20120716 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy MINERAL OIL 118 mL/118mL 59779-997_f15f7e40-b282-489a-aef3-27f29d3722bd 59779-997 HUMAN OTC DRUG CVS Hemorrhoidal Topical Analgesic Dibucaine OINTMENT TOPICAL 20140117 OTC MONOGRAPH FINAL part346 CVS Pharmacy, Inc. DIBUCAINE 10 mg/g 59779-998_6688e262-6ac8-4641-93d4-7086386079d2 59779-998 HUMAN OTC DRUG hydrocortisone 1 anti itch Hydrocortisone Acetate OINTMENT TOPICAL 20050609 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy HYDROCORTISONE ACETATE 1.12 g/100g 59779-999_c6786f82-9d96-4c13-907e-9d4719bd96cb 59779-999 HUMAN OTC DRUG Regular Strength Sleep-Aid Diphenhydramine HCl TABLET ORAL 19921225 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59788-001_ed740912-5603-4e7e-830b-a002a9ca67fb 59788-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19860501 UNAPPROVED MEDICAL GAS Arcet Equipment Company OXYGEN 995 mL/L 59788-002_6a6f02fd-14a8-42c9-b7b2-664fa5b099ee 59788-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20070115 UNAPPROVED MEDICAL GAS Arcet Equipment Company NITROGEN 990 mL/L 59800-0107_35b24f49-2cab-42c2-bf25-01259a21fc51 59800-0107 HUMAN OTC DRUG DERMAKLEAR AKNE TREATMENT WITH SULFUR SULFUR SOAP TOPICAL 20040701 OTC MONOGRAPH FINAL part358H Enzymatic Therapy, LLC SULFUR 5 g/85g 59800-0232_c6e443c1-dca4-4d69-aaf3-6c35671b3c74 59800-0232 HUMAN OTC DRUG Air Power GUAIFENESIN TABLET ORAL 20030519 OTC MONOGRAPH FINAL part341 Enzymatic Therapy, LLC GUAIFENESIN 200 mg/1 59800-0974_22dc4b0f-9ce3-433b-9de8-434e9bf1c762 59800-0974 HUMAN OTC DRUG Cold Sore Relief allantoin CREAM TOPICAL 19940619 OTC MONOGRAPH FINAL part347 Enzymatic Therapy, Inc. ALLANTOIN 50 mg/5g 59800-7232_26ee7aa5-e267-4310-b449-be68db7a9955 59800-7232 HUMAN OTC DRUG MucaPlex GUAIFENESIN TABLET ORAL 20051001 OTC MONOGRAPH FINAL part341 Enzymatic Therapy, LLC GUAIFENESIN 200 mg/1 59800-8001_b5e440cb-23ae-4d10-9b41-8f4da7a8ed36 59800-8001 HUMAN OTC DRUG ViraClear EPs 7630 Original Pelargonium sidoides LIQUID ORAL 20090824 UNAPPROVED HOMEOPATHIC Enzymatic Therapy, LLC PELARGONIUM SIDOIDES ROOT 1 [hp_X]/30mL 59800-8002_2e3f42a2-78b3-4723-a3f0-4519db6cbafc 59800-8002 HUMAN OTC DRUG ViraClear EPs 7630 Cherry Flavor Pelargonium sidoides LIQUID ORAL 20090824 UNAPPROVED HOMEOPATHIC Enzymatic Therapy, Inc. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/120mL 59824-0008_2b9727ef-da2c-4d81-8091-7fc541c4a21a 59824-0008 HUMAN OTC DRUG PainMed Homeopathic Pain Relieving External ACONITUM NAPELLUS, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA ALBA ROOT, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, and RUTA GRAVEOLENS FLOWERING TOP GEL TOPICAL 20030801 UNAPPROVED HOMEOPATHIC G M International, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP 3; 6; 1; 12; 1; 2; 2; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 59834-202_d44b632d-0f53-4063-9479-27b5f9a92727 59834-202 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20110901 ANDA ANDA065326 OrchidPharma Inc CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 59834-203_d44b632d-0f53-4063-9479-27b5f9a92727 59834-203 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20110901 ANDA ANDA065326 OrchidPharma Inc CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 59842-012_f4006023-6212-43c8-9f08-e3b1ab89086e 59842-012 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20010402 UNAPPROVED MEDICAL GAS Fitzsimmons Surgical Supply, Inc OXYGEN 99 L/100L 59846-681_7dde6af8-4006-44c4-8d12-ff3998a8edfb 59846-681 HUMAN OTC DRUG PRO-SOURCE ANTIMICROBIAL HAND CLEANING WIPES BENZALKONIUM CHLORIDE CLOTH TOPICAL 20131017 OTC MONOGRAPH NOT FINAL part333E MSC Industrial Supply BENZALKONIUM CHLORIDE .01417 g/1 59854-299_981196fc-65d7-4163-8e0a-b8c78d03b3df 59854-299 HUMAN OTC DRUG Bacti-Free tm Hand Sanitizer ALCOHOL LIQUID TOPICAL 20080301 OTC MONOGRAPH NOT FINAL part333E Johnson Labs, Inc. ALCOHOL .29326 L/.473L 59854-300_5c858de3-d3f8-434a-a651-d2ba9a5ff78f 59854-300 HUMAN OTC DRUG Bacti-Free tm Antibacterial Hand TRICLOSAN LIQUID TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333A Johnson Labs, Inc. TRICLOSAN .0189 L/3.78L 59854-301_d76f4f10-eba1-455e-8568-2291e6fad7ad 59854-301 HUMAN OTC DRUG DELUXE ALL-PURPOSE TRICLOSAN LIQUID TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333A Johnson Labs, Inc. TRICLOSAN 7.57 mL/3.78L 59860-519_1d5d7de1-7c91-4713-aaee-bac2ad0073cb 59860-519 HUMAN OTC DRUG IRIS ANTIMICROBIAL HAND SANITIZER ALCOHOL SOAP TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333E Smart and Final Stores ALCOHOL .62 mL/mL 59860-545_50ded083-b0da-4abb-9374-3cfa3ec769a4 59860-545 HUMAN OTC DRUG IRIS ANTIMICROBIAL HAND CHLOROXYLENOL SOAP TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333E SMART AND FINAL STORES CHLOROXYLENOL 3 g/1000mL 59863-325_0b56ab35-71e8-4a91-b00e-61369250e193 59863-325 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990104 UNAPPROVED MEDICAL GAS Banner Home Care of Arizona OXYGEN 99 L/100L 59875-1005_21f8e5e3-59bb-41b5-8d95-ae7900994a4a 59875-1005 HUMAN OTC DRUG Lab1796 Cold and Flu Armor Aconitum napellus, Onion, Arnica montana, Antropa Belladonna, Solanum Dulcamara Top, Eupatorium Cannabinum Whole Flowering, Gelsemium Sempervirens Root PELLET ORAL 20110101 UNAPPROVED HOMEOPATHIC HomeopathyStore.com ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; EUPATORIUM CANNABINUM WHOLE FLOWERING; GELSEMIUM SEMPERVIRENS ROOT; ONION; SOLANUM DULCAMARA TOP 14; 8; 8; 8; 18; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 59875-1010_848732bf-c7c5-4f2c-8f80-176ef65be280 59875-1010 HUMAN OTC DRUG Lab1796 Sinus Appeaser Asafetida, Echinacea angustifolia, Calcium sulfide, Potassium dichromate, Luffa operculata fruit, Silicon dioxide, Sinusitisinum PELLET ORAL 20110115 UNAPPROVED HOMEOPATHIC HomeopathyStore.com ASAFETIDA; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA; LUFFA OPERCULATA FRUIT; POTASSIUM DICHROMATE; SILICON DIOXIDE; SINUSITISINUM 8; 8; 12; 9; 18; 10; 18 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 59875-1015_8d8f2b97-8138-49b0-87e3-c84801f2dc6c 59875-1015 HUMAN OTC DRUG Lab1796 Sore Throat Soothe Aconitum napellus, Apis mellifera, Atropa belladonna, Solanum dulcamara top, Mercurius solubilis, Phytolacca americana root PELLET ORAL 20110101 UNAPPROVED HOMEOPATHIC HomeopathyStore.com ACONITUM NAPELLUS; APIS MELLIFERA; ATROPA BELLADONNA; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; SOLANUM DULCAMARA TOP 10; 10; 10; 10; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 59875-1020_f571a1b5-9535-45ea-bbab-148e60a283ad 59875-1020 HUMAN OTC DRUG Lab1796 Allergy Escape Onion, Apis mellifera, Drosera rotundifolia, Euphrasia stricta, Histamine dihydrochloride, Urtica urens SPRAY ORAL 20111001 UNAPPROVED HOMEOPATHIC HomeopathyStore.com APIS MELLIFERA; DROSERA ROTUNDIFOLIA; EUPHRASIA STRICTA; HISTAMINE DIHYDROCHLORIDE; ONION; URTICA URENS 8; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 59875-2005_55eb29b4-2540-4698-879e-298b38d56705 59875-2005 HUMAN OTC DRUG Lab1796 Stress Absorber Strychnos nux-vomica seed, Silver nitrate, Datura stramonium, Strychnos ignatii seed, Phosphoric acid, Matricaria recutita, Coffee bean PELLET ORAL 20110115 UNAPPROVED HOMEOPATHIC HomeopathyStore.com COFFEE BEAN; DATURA STRAMONIUM; MATRICARIA RECUTITA; PHOSPHORIC ACID; SILVER NITRATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED 8; 10; 8; 8; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 59875-2010_7c96fc52-32cd-4f4c-995e-ef3ea27acef7 59875-2010 HUMAN OTC DRUG Lab1796 Anxiety Shield Aconitum napellus, Silver nitrate, Arsenic trioxide, Matricaria recutita, Coffee Bean, Gelsemium sempervirens root, Strychnos ignatii seed PELLET ORAL 20110115 UNAPPROVED HOMEOPATHIC HomeopathyStore.com ACONITUM NAPELLUS; ARSENIC TRIOXIDE; COFFEE BEAN; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA RECUTITA; SILVER NITRATE; STRYCHNOS IGNATII SEED 30; 30; 9; 9; 12; 12; 9 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 59875-3005_ed9167d8-289e-478d-9bfd-f89364f4afb5 59875-3005 HUMAN OTC DRUG Lab1796 High Blood Pressure Guard Barium carbonate, Atropa belladonna, Nitroglycerin, Lycopus virginicus, Strychnos nux-vomica seed, Lead PELLET ORAL 20110115 UNAPPROVED HOMEOPATHIC HomeopathyStore.com ATROPA BELLADONNA; BARIUM CARBONATE; LEAD; LYCOPUS VIRGINICUS; NITROGLYCERIN; STRYCHNOS NUX-VOMICA SEED 4; 4; 4; 6; 4; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 59875-3010_7ef48de9-ef85-4f4e-9999-bb5c20fca4b3 59875-3010 HUMAN OTC DRUG Lab1796 Cholsterol Watch Arctium lappa root, Berberis vulgaris root bark, Silybum marianum seed, Chelidonium majus, Cholesterol, Chrysanthellum indicum subsp. afroamericanum, Solidago virgaurea flowering top, Taraxacum offici PELLET ORAL 20110115 UNAPPROVED HOMEOPATHIC HomeopathyStore.com ARCTIUM LAPPA ROOT; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; CHOLESTEROL; CHRYSANTHELLUM INDICUM SUBSP. AFROAMERICANUM; SILYBUM MARIANUM SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE 4; 4; 4; 9; 4; 4; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 59875-4005_27c8c1b9-1bb8-4385-9f7d-af595d6d09f9 59875-4005 HUMAN OTC DRUG Lab1796 Headache Ease Atropa Belladonna, Cyclamen purpurascens tuber, Coffee Bean, Iris versicolor root, Strychnos nux-vomica seed, Sanguinaria canadensis root, Spigelia marilandica root, Viburnum opulus bark PELLET ORAL 20110801 UNAPPROVED HOMEOPATHIC HomeopathyStore.com ATROPA BELLADONNA; COFFEE BEAN; CYCLAMEN PURPURASCENS TUBER; IRIS VERSICOLOR ROOT; SANGUINARIA CANADENSIS ROOT; SPIGELIA MARILANDICA ROOT; STRYCHNOS NUX-VOMICA SEED; VIBURNUM OPULUS BARK 8; 4; 8; 8; 8; 8; 9; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 59875-9001_6aa603d0-c957-4a68-82ca-5eb803b6d5b3 59875-9001 HUMAN OTC DRUG Lab1796 Detox Escort Horse chestnut,Antimony trisulfide,Silver nitrate,Arnica montana,Berberis vulgaris root bark,Activated charcoal,Ceanothus americanus leaf,Cholesterol,Cinchona officinalis bark,Artichoke,Equisetum arve SOLUTION/ DROPS ORAL 20110115 UNAPPROVED HOMEOPATHIC HomeopathyStore.com ACTIVATED CHARCOAL; ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARNICA MONTANA; ARTICHOKE; BERBERIS VULGARIS ROOT BARK; CEANOTHUS AMERICANUS LEAF; CHAMAELIRIUM LUTEUM ROOT; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CONYZA CANADENSIS; DAIKON; EQUISETUM ARVENSE TOP; FUCUS VESICULOSUS; GINKGO; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; LESPEDEZA CAPITATA FLOWERING TOP; RANUNCULUS BULBOSUS; ROBINIA PSEUDOACACIA BARK; SILVER NITRATE; TARAXACUM OFFICINALE; VIBURNUM PRUNIFOLIUM BARK; WINE GRAPE 9; 6; 6; 6; 6; 6; 6; 6; 10; 8; 6; 6; 6; 6; 10; 6; 6; 6; 6; 4; 10; 10; 6; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 59877-0001_bcf1c0b1-808b-4ba1-b290-075d201e5930 59877-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850801 UNAPPROVED MEDICAL GAS Link Medical, Inc. OXYGEN 99 L/100L 59883-166_3ee5dfad-b16e-4a03-8029-e7dcd10e6287 59883-166 HUMAN OTC DRUG Pro-Den Rx Sodium Fluoride GEL ORAL 20081121 OTC MONOGRAPH FINAL part352 Zila Therapeutics, Inc. SODIUM FLUORIDE .044 mL/mL 59883-168_7f549575-e740-4963-b105-ef4b4f850a2d 59883-168 HUMAN OTC DRUG Pro-Den Rx Sodium Fluoride GEL ORAL 20081121 OTC MONOGRAPH FINAL part352 Zila Therapeutics, Inc. SODIUM FLUORIDE .044 mL/mL 59883-175_4bd2415b-5569-4f4e-886f-6d4b95acbf15 59883-175 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20090618 ANDA ANDA077789 Zila, Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] 59883-648_714b5124-ac4f-4a16-8961-4a6b9e16811b 59883-648 HUMAN OTC DRUG Pro-Den Rx Stannous Fluoride GEL ORAL 20081013 OTC MONOGRAPH FINAL part355 Zila Therapeutics, Inc. STANNOUS FLUORIDE 1.3 mg/mL 59883-720_089cae97-fcd1-4edb-857f-58b694e63284 59883-720 HUMAN OTC DRUG Pro-Den Rx Sodium Fluoride GEL ORAL 20081031 OTC MONOGRAPH FINAL part355 Zila Therapeutics, Inc. STANNOUS FLUORIDE 1.8 g/g 59883-820_beb13947-14f8-4eef-9082-690f7cd521e8 59883-820 HUMAN OTC DRUG Pro-Den Rx Sodium Fluoride GEL ORAL 20081031 OTC MONOGRAPH FINAL part355 Zila Therapeutics, Inc. SODIUM FLUORIDE 4.3 g/g 59883-821_1e7e7d6a-d14d-4542-9e0b-7f122d75e9ae 59883-821 HUMAN OTC DRUG Pro-Den Rx Sodium Fluoride GEL ORAL 20081121 OTC MONOGRAPH FINAL part352 Zila Therapeutics, Inc. SODIUM FLUORIDE 4.3 g/g 59883-824_136b148c-5e9c-4d24-8dd9-97a655daaf83 59883-824 HUMAN OTC DRUG Pro-Den Rx Sodium Fluoride GEL ORAL 20090120 OTC MONOGRAPH FINAL part355 Zila Therapeutics, Inc. SODIUM FLUORIDE 4.3 g/g 59883-826_66a11743-d0f6-4a96-bb61-46b58941dca1 59883-826 HUMAN OTC DRUG Pro-Den Rx Sodium Fluoride GEL ORAL 20090120 OTC MONOGRAPH FINAL part355 Zila Therapeutics, Inc. SODIUM FLUORIDE 4.3 g/g 59883-920_11f588d2-a2fa-48fa-b8bd-5b58710179ee 59883-920 HUMAN OTC DRUG Pro-Den Rx Sodium Fluoride RINSE ORAL 20081001 OTC MONOGRAPH FINAL part355 Zila Therapeutics, Inc. SODIUM FLUORIDE .9 mg/mL 59883-922_11f588d2-a2fa-48fa-b8bd-5b58710179ee 59883-922 HUMAN OTC DRUG Pro-Den Rx Sodium Fluoride RINSE ORAL 20081001 OTC MONOGRAPH FINAL part355 Zila Therapeutics, Inc. SODIUM FLUORIDE .9 mg/mL 59886-304_02d8f0fb-f916-4a68-9c13-549489df62be 59886-304 HUMAN OTC DRUG ULTRASOL nature BABY Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd TITANIUM DIOXIDE; ZINC OXIDE 15; 8 g/100g; g/100g 59886-308_b0d3f0b1-41ec-45b8-8d70-60fae969f660 59886-308 HUMAN OTC DRUG UltrasolSunscreen KIDS Sunscreen Lotion SPF 34 Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 3; 3 g/100g; g/100g; g/100g; g/100g 59886-309_72bcd16f-9353-4677-ac76-8d60fc705466 59886-309 HUMAN OTC DRUG UltrasolSunscreen KIDS Sunscreen Lotion Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g 59886-315_e9cb9def-999e-4e0e-8db2-72e2203e8663 59886-315 HUMAN OTC DRUG UltrasolSunscreen KIDS Sunscreen Spray Lotion SPF 30 Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 7.5; 5; 7.5; 4 g/100g; g/100g; g/100g; g/100g; g/100g 59886-316_52182e84-280a-41db-b234-fc974b30a8f3 59886-316 HUMAN OTC DRUG UltrasolSunscreen KIDS Sunscreen Mousse Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, FOAM TOPICAL 20100410 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 7.5; 5; 9; 4 g/100g; g/100g; g/100g; g/100g; g/100g 59886-318_e07969eb-b3a6-49f3-8463-bee2af800bdf 59886-318 HUMAN OTC DRUG UltrasolSunscreen Sunscreen Lotion SPF 15 Avobenzone, Octisalate, Octocrylene LOTION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 7 g/100g; g/100g; g/100g 59886-319_281820aa-02d6-4549-8ca2-c0e6a94e308e 59886-319 HUMAN OTC DRUG UltrasolSunscreen Sunscreen Lotion SPF 34 Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 3; 3 g/100g; g/100g; g/100g; g/100g 59886-320_91453fc8-b945-4cdc-a3fd-5540b8158873 59886-320 HUMAN OTC DRUG UltrasolSunscreen Sunscreen Lotion SPF 34 Avobenzone , Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 3; 3 g/100g; g/100g; g/100g; g/100g 59886-322_dc7380b8-5a08-450d-91fd-c863d62f69f6 59886-322 HUMAN OTC DRUG UltrasolSunscreen Sunscreen Lotion SPF45 Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g 59886-326_bf0fa058-ac30-4641-8233-31441b298770 59886-326 HUMAN OTC DRUG UltrasolSunscreen Sunscreen Face Cream SPF 34 Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 3; 3 g/100g; g/100g; g/100g; g/100g 59886-327_3ff7c8ee-af7b-4376-aff3-e2719fcaa027 59886-327 HUMAN OTC DRUG Ultrasol KIDS Sunscreen Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g 59886-330_2b1ca574-2c21-4aba-8b89-0c24d34385f1 59886-330 HUMAN OTC DRUG UltrasolSunscreen Sunscreen Spray Lotion SPF 15 Avobenzone, Octinoxate, Oxybenzone SPRAY TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer pharmaceuticals Ltd. AVOBENZONE; OCTINOXATE; OXYBENZONE 2; 7.5; 4 g/100g; g/100g; g/100g 59886-336_c9fec2fe-1d6a-4006-b0ad-af98813d369f 59886-336 HUMAN OTC DRUG Ultrasol nature BABY Sunscreen Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g 59886-337_1816044f-baee-4357-b24b-b2cf57b282a3 59886-337 HUMAN OTC DRUG UltrasolSunscreen nature BABY Sunscreen Face Cream SPF 45 Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g 59886-338_b3178a66-5580-44fc-a0a4-71171c9af76a 59886-338 HUMAN OTC DRUG Ultrasol OIL-FREE Sunscreen Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g 59886-339_b598d15e-72c4-4598-80a3-ff052b6fb494 59886-339 HUMAN OTC DRUG Ultrasol Sport Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g 59886-340_b25ee570-a66f-4b6d-94fb-60d498536e77 59886-340 HUMAN OTC DRUG UltrasolSunscreen Sport Sunscreen Lotion CONTINUOUS SPRAY SPF 45 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.5; 5; 7.5; 5; 9; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 59886-343_8fd7e133-7190-467f-bd4a-7dd198b7695a 59886-343 HUMAN OTC DRUG UltrasolSunscreen Sunscreen Lotion Continuous Spray SPF 45 Avobenzone, Homosalate, Octinoxate , Octisalate , Octocrylene , Oxybenzone AEROSOL, SPRAY TOPICAL 20100430 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.5; 5; 7.5; 5; 9; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 59886-344_a6b8794d-3375-4323-9436-b16cb66579a3 59886-344 HUMAN OTC DRUG UltrasolSunscreen KIDS Sunscreen Lotion Continuous Spray SPF 45 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene , Oxybenzone AEROSOL, SPRAY TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.5; 5; 7.5; 5; 9; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 59886-346_6e5889d6-7bb8-45d0-b4e9-f58169edb683 59886-346 HUMAN OTC DRUG UltrasolSunscreen Clear CONTINUOUS SPRAY SPF43 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20100410 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 7.5; 5; 6; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 59886-347_85f61e37-0741-4fd6-814b-09ecbba1fa02 59886-347 HUMAN OTC DRUG UltrasolSunscreen KIDS Clear CONTINUOUS SPRAY Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20100410 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 7.5; 5; 6; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 59886-348_02939687-39e7-4d7b-b90a-bea57cc6332a 59886-348 HUMAN OTC DRUG UltrasolSunscreen Sport Clear CONTINUOUS SPRAY Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20100410 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 7.5; 5; 6; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 59886-349_e4af34be-9c7f-4d8c-8d33-cb7581e497c7 59886-349 HUMAN OTC DRUG ULTRASOL nature BABY Sunscreen Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd TITANIUM DIOXIDE; ZINC OXIDE 15; 8 g/100g; g/100g 59886-350_53985bf1-f1dc-4a0f-95cf-447040ff2bc6 59886-350 HUMAN OTC DRUG ULTRASOL Sport Sunscreen Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.5; 5; 7.5; 5; 9; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 59886-351_d7733ee0-7848-457c-a4e9-de015feeb87d 59886-351 HUMAN OTC DRUG ULTRASOL Sunscreen Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.5; 5; 7.5; 5; 9; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 59886-352_27f9ee8c-31fd-4c97-8209-c521eb2e4d1e 59886-352 HUMAN OTC DRUG ULTRASOL Sunscreen SPF45 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.5; 5; 7.5; 5; 9; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 59886-353_1a362e48-3a54-4443-97eb-5e996e920223 59886-353 HUMAN OTC DRUG ULTRASOL KIDS Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, FOAM TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 7.5; 5; 9; 4 g/100g; g/100g; g/100g; g/100g; g/100g 59886-354_e48d3a18-7ad3-4aa9-96de-2a8739db0505 59886-354 HUMAN OTC DRUG Ultrasol Sport Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100625 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g 59886-355_5426e82e-6214-4e8e-a36f-7f83796a1836 59886-355 HUMAN OTC DRUG ULTRASOL Sunscreen Lotion SPF 45 Avobenzone, Octinoxate, Octisalate, Oxyybenzone LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g 59886-410_c9bcd009-a78c-494f-a0ac-fb13d9c90e60 59886-410 HUMAN OTC DRUG Asepxia Facial cleansing SALICYLIC ACID CLOTH TOPICAL 20110130 OTC MONOGRAPH FINAL part333D Fischer Pharmaceuticals Ltd. SALICYLIC ACID .5 g/100g 59886-413_c0130cb8-503c-4e55-b897-4c3a84e4ba1f 59886-413 HUMAN OTC DRUG Olivene Diaper Rash Zinc Oxide OINTMENT TOPICAL 20130111 OTC MONOGRAPH FINAL part347 Fischer Pharmaceuticlas Ltd. ZINC OXIDE 400 mg/g 59896-520_7d8c729d-508a-4832-9254-600af3de1294 59896-520 HUMAN OTC DRUG MAYFAIR ANTI-BACTERIAL HAND SANITIZER ALCOHOL SOAP TOPICAL 20131016 OTC MONOGRAPH NOT FINAL part333E Sellars Absorbent Materials ALCOHOL .62 mL/mL 59896-682_2319b06e-741d-49fb-8a5a-c3afb6ac0b75 59896-682 HUMAN OTC DRUG MAYFAIR HAND SANITIZING WIPES WITH ALOE BENZALKONIUM CHLORIDE CLOTH TOPICAL 20131016 OTC MONOGRAPH NOT FINAL part333E Sellars Absorbent Materials BENZALKONIUM CHLORIDE .0067275 g/1 59898-120_bfe60e4a-9e90-437e-b378-823ca9c95899 59898-120 HUMAN OTC DRUG R2 Avobenzone, Homosalate, Octinoxate, Octocrylene LOTION TOPICAL 20100814 OTC MONOGRAPH NOT FINAL part352 Water-Jel Technologies AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3; 7.5; 5; 2.7 g/100mL; g/100mL; g/100mL; g/100mL 59898-121_a76faa2d-6b9d-4359-8eb5-33d47e5ae25b 59898-121 HUMAN OTC DRUG R2 Skin Protectant Dimethicone LOTION TOPICAL 20140201 OTC MONOGRAPH FINAL part332 Water-Jel Technologies DIMETHICONE 2 g/100g 59898-122_fc2b9406-5f46-4634-8c87-f073ace97f8a 59898-122 HUMAN OTC DRUG Radiaderm System Kit Dimethicone LOTION TOPICAL 20140201 OTC MONOGRAPH FINAL part332 Water-Jel Technologies DIMETHICONE 2 g/100g 59898-123_e8055f92-176a-472a-98c2-13b53a8df696 59898-123 HUMAN OTC DRUG Radiaderm Starter Kit Dimethicone LOTION TOPICAL 20140201 OTC MONOGRAPH FINAL part332 Water-Jel Technologies DIMETHICONE 2 g/100g 59898-130_7ba183e4-d4dc-42ca-bc2a-c8d7ae7b1bd9 59898-130 HUMAN OTC DRUG R2 System Avobenzone, Homosalate, Octinoxate, Octocrylene LOTION TOPICAL 20100814 OTC MONOGRAPH NOT FINAL part352 Water-Jel Technologies AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3; 7.5; 5; 2.7 g/100mL; g/100mL; g/100mL; g/100mL 59898-140_c8a460a0-4194-4fcd-9f00-070021c4f2e6 59898-140 HUMAN OTC DRUG EBSL-5 Lidocaine Hydrochloride KIT 20140611 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies 59898-160_3cf8e94e-bc74-430f-83c7-4e150e0b3452 59898-160 HUMAN OTC DRUG EBSS-5 Lidocaine Hydrochloride KIT 20140611 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies 59898-170_4507adef-f760-45bf-9560-a2ec418ffd46 59898-170 HUMAN OTC DRUG FSK-5 Lidocaine Hydrochloride KIT 20140611 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies 59898-180_8029f983-c83d-414e-8c3b-b78e5d249eb8 59898-180 HUMAN OTC DRUG IWK-5 Lidocaine Hydrochloride KIT 20140612 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies 59898-200_979ba421-bdc3-4fd0-b84d-d065cd057e9e 59898-200 HUMAN OTC DRUG Burn Jel Gel for Burns GEL TOPICAL 20100417 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies LIDOCAINE HYDROCHLORIDE 2 g/100mL 59898-201_1c1ece31-8529-43e5-b805-c5d0dd3c1b81 59898-201 HUMAN OTC DRUG Burn Mist Lidocaine Hydrochloride SPRAY TOPICAL 20100517 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies LIDOCAINE HYDROCHLORIDE 2 g/100mL 59898-205_16f671ef-268c-4e20-93bf-0376885e3b16 59898-205 HUMAN OTC DRUG Burn Jel Plus Gel for Burns GEL TOPICAL 20100410 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies LIDOCAINE HYDROCHLORIDE 2.5 g/100mL 59898-401_822566dd-3d55-4142-a59b-b0f5a93cd1ba 59898-401 HUMAN OTC DRUG First Aid Antiseptic Benzalkonium chloride SPRAY TOPICAL 20100522 OTC MONOGRAPH NOT FINAL part333 Water-Jel Technologies BENZALKONIUM CHLORIDE .13 g/100mL 59898-402_636358b4-e9a8-4d84-8c9f-99494e79a9d2 59898-402 HUMAN OTC DRUG Isopro First Aid Isopropyl Alcohol SPRAY TOPICAL 20100523 OTC MONOGRAPH NOT FINAL part333 Water-Jel Technologies ISOPROPYL ALCOHOL 70 mL/100mL 59898-403_8e911b60-094b-4ef7-bf2d-f6735a51547e 59898-403 HUMAN OTC DRUG Water Jel Hydrogen Peroxide Hydrogen Peroxide SPRAY TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333A Water-Jel Technologies HYDROGEN PEROXIDE 3 mL/100mL 59898-420_dbc1e66a-fc17-4cb4-9eac-134add516735 59898-420 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20100415 OTC MONOGRAPH NOT FINAL part333E Water-Jel Technologies ALCOHOL 62 mL/100mL 59898-500_ed2a2e64-ccfe-48b3-9980-2902c09a48c9 59898-500 HUMAN OTC DRUG Unburn Lidocaine hydrochloride GEL TOPICAL 20130317 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies LIDOCAINE HYDROCHLORIDE 2.5 g/100mL 59898-510_eb94c82d-eb56-45fa-a437-281eddb961a1 59898-510 HUMAN OTC DRUG Unburn Lidocaine hydrochloride SPRAY TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies LIDOCAINE HYDROCHLORIDE 2.5 g/100mL 59898-721_4b26e738-311f-41e4-8745-49d3042a8ad0 59898-721 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20101107 OTC MONOGRAPH FINAL part333B Water-Jel Technologies BACITRACIN ZINC 500 [iU]/g 59898-730_2396a481-9327-4a88-8bf0-8045ac24aafb 59898-730 HUMAN OTC DRUG Water-Jel Neomycin Antibiotic First Aid Ointment OINTMENT TOPICAL 20100331 OTC MONOGRAPH FINAL part333 Water-Jel Technologies NEOMYCIN SULFATE 3.5 mg/g 59898-740_459fc89d-64a2-455b-b0c4-7906d1adc89e 59898-740 HUMAN OTC DRUG Water-Jel 3-in-1 Antibiotic Bacitracin zinc, Polymyxin B Sulfate, Neomycin Sulfate OINTMENT TOPICAL 20100330 OTC MONOGRAPH FINAL part333B Water-Jel Technologies BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 417.8; 3.5; 5322.8 [iU]/g; mg/g; [iU]/g 59898-800_44191dd1-6b56-456d-b503-3e996e0a2d5f 59898-800 HUMAN OTC DRUG HYDROCORTISONE Anti-itch cream OINTMENT TOPICAL 20100430 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies HYDROCORTISONE ACETATE 1 g/100g 59898-805_973feabd-0342-4e95-b02c-909ce7265da1 59898-805 HUMAN OTC DRUG MUSCLE Menthol GEL TOPICAL 20100419 OTC MONOGRAPH NOT FINAL part348 WATER-JEL TECHNOLOGIES MENTHOL 3.5 g/100mL 59898-810_a465d4a9-e5a8-4039-acf1-70576b49980f 59898-810 HUMAN OTC DRUG Itch Relief Diphenhydramine Hydrochloride SPRAY TOPICAL 20100925 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies DIPHENHYDRAMINE HYDROCHLORIDE 2 g/100mL 59898-902_474bd25c-15fb-4de8-b6c3-d9903f606408 59898-902 HUMAN OTC DRUG First Aid Burn Benzalkonium Chloride, Lidocaine Hydrochloride CREAM TOPICAL 20100420 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .13; .5 g/100g; g/100g 59899-001_fe897694-4057-4bf5-9f0f-6fe13451e8de 59899-001 HUMAN OTC DRUG Enfuselle Time Repair A.M. SPF15 HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20130807 OTC MONOGRAPH FINAL part352 Shaklee Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 35 mg/mL; mg/mL; mg/mL; mg/mL 59899-002_13897f90-63df-4734-a6b3-6df26ffc8cf8 59899-002 HUMAN OTC DRUG enfuselle Acne Clarifying SALICYLIC ACID CREAM TOPICAL 20130808 OTC MONOGRAPH FINAL part333D Shaklee Corporation SALICYLIC ACID 5 mg/mL 59899-003_0685c945-6862-45b6-8462-11d8bbe23c7a 59899-003 HUMAN OTC DRUG Antiperspirant Aluminum Chlorohydrate CREAM TOPICAL 20130808 OTC MONOGRAPH FINAL part350 SHAKLEE CORPORATION ALUMINUM CHLOROHYDRATE 20 g/100g 59899-004_36da92f0-71cb-4ac3-bb5e-713077c6ff36 59899-004 HUMAN OTC DRUG Roll-On Antiperspirant Aluminum Chlorohydrate CREAM TOPICAL 20130808 OTC MONOGRAPH FINAL part350 SHAKLEE CORPORATION ALUMINUM CHLOROHYDRATE 200 mg/mL 59899-005_0bae42b9-7350-46a5-931a-8b9a62713346 59899-005 HUMAN OTC DRUG Joint and Muscle Pain Menthol CREAM TOPICAL 20130808 OTC MONOGRAPH NOT FINAL part348 Shaklee Corporation MENTHOL 5 g/100g 59899-006_51b0d7c1-3cbf-4eaf-96e3-721062f74a13 59899-006 HUMAN OTC DRUG Enfuselle Lip Treatment SPF 15 Broad Spectrum OCTISALATE, AVOBENZONE, and OCTOCRYLENE STICK TOPICAL 20131111 OTC MONOGRAPH FINAL part352 Shaklee Corporation AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 5 g/g; g/g; g/g 59899-007_0fba8c74-baf9-47b2-b042-c58ea75747c8 59899-007 HUMAN OTC DRUG enfuselle BODY SUNSCREEN BROAD SPECTRUM SPF 30 HOMOSALATE, OCTISALATE, AVOBENZONE, and OCTOCRYLENE LOTION TOPICAL 20131111 OTC MONOGRAPH FINAL part352 Shaklee Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL 59899-008_3df1e6a5-dafe-4317-a7d2-5051030d30b8 59899-008 HUMAN OTC DRUG Joint and Muscle Pain Menthol CREAM TOPICAL 20131111 OTC MONOGRAPH NOT FINAL part348 Shaklee Corporation MENTHOL 5 g/100g 59900-102_17c8f928-259f-4e8c-a682-ba263f3f8378 59900-102 HUMAN OTC DRUG Smart San Healthcare Personnel Handwash Ethanol LIQUID TOPICAL 20000601 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc ETHANOL 710 g/1000mL 59900-107_f3381727-30d0-4e87-b5c2-a0a19f727a8f 59900-107 HUMAN OTC DRUG Alpet E3 Hand Sanitizer Spray Isopropyl Alcohol LIQUID TOPICAL 19950101 OTC MONOGRAPH NOT FINAL part352 Best Sanitizer, Inc. ISOPROPYL ALCOHOL 760 g/1000mL 59900-110_7d4b3f7f-716f-4e42-9630-ecde825b3d53 59900-110 HUMAN OTC DRUG Alpet E3 Plus Hand Sanitizer Spray Ethanol LIQUID TOPICAL 19990401 OTC MONOGRAPH NOT FINAL part352 Best Sanitizer, Inc. ETHANOL 710 g/1000mL 59900-111_7c2c757b-1280-4f42-a2af-49794269ff18 59900-111 HUMAN OTC DRUG Smart San Hand Sanitizer Spray Ethanol LIQUID TOPICAL 20040701 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc ETHANOL 710 g/1000mL 59900-112_8d3682da-2120-4abf-8f83-76414f796a5f 59900-112 HUMAN OTC DRUG Smart San Hand Sanitizer Spray Fragrenace-Free Ethanol LIQUID TOPICAL 20040701 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc ETHANOL 710 g/1000mL 59900-114_ec24daaf-5db7-41eb-beb8-970c075b99df 59900-114 HUMAN OTC DRUG Smart San ES Hand Sanitizer Spray Ethanol LIQUID TOPICAL 20040701 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc ETHANOL 652.2 g/1000mL 59900-116_67eb6c79-c6a0-486d-ae41-2efdac98ccbb 59900-116 HUMAN OTC DRUG Smart San Hand Sanitizer Ethanol LIQUID TOPICAL 20010401 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc ETHANOL 693 g/1000mL 59900-117_c324e7db-5a74-4402-b9a8-42fa8c2700fe 59900-117 HUMAN OTC DRUG Smart San Hand Sanitizer Ethanol LIQUID TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc ETHANOL 672 g/1000mL 59900-118_6b256eac-d382-45c1-bcfa-e24be36f2f35 59900-118 HUMAN OTC DRUG Smart San Alcohol Free Hand Sanitizer Foam Benzalkonium Chloride LIQUID TOPICAL 20090715 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc BENZALKONIUM CHLORIDE 10 g/1000mL 59900-120_6225a531-1741-497e-861e-dbbb1ef9d02c 59900-120 HUMAN OTC DRUG All Fresh by Alsco Instant Mist Hand Sanitizer Ethanol LIQUID TOPICAL 20050301 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc ETHANOL 710 g/1000mL 59900-130_dd1049db-713c-44f5-a4ba-473eb815e34a 59900-130 HUMAN OTC DRUG Alpet Q E2 Benzalkonium Chloride LIQUID TOPICAL 20090715 OTC MONOGRAPH NOT FINAL part333E Best Sanitizers, Inc BENZALKONIUM CHLORIDE 1.2 g/1000mL 59900-208_9a4581bf-af43-4f27-b19a-da3fe44fb143 59900-208 HUMAN OTC DRUG Alpet E2 Sanitizing Foam Soap Chloroxylenol SOAP TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 Best Sanitizer, Inc. CHLOROXYLENOL 250 g/1000mL 59900-211_d69a0eeb-a55e-4560-80e9-120ccfecf207 59900-211 HUMAN OTC DRUG Soften Sure Foam Soap Antimicrobial Chloroxylenol LIQUID TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc CHLOROXYLENOL 189 g/1000mL 59900-510_243da975-37ea-4fa5-8d65-aeba9f0ce5b6 59900-510 HUMAN OTC DRUG HACCP Flat Top E-2 chloroxylenol LIQUID TOPICAL 19981028 OTC MONOGRAPH NOT FINAL part333E Best Sanitizers Inc. CHLOROXYLENOL 15.75 g/1000mL 59900-718_42390fed-6bd8-4840-a0cd-e4f2a6f51184 59900-718 HUMAN OTC DRUG HACCP QE2 Benzalkonium Chloride LIQUID TOPICAL 20140716 OTC MONOGRAPH NOT FINAL part333E Best Sanitizers, Inc BENZALKONIUM CHLORIDE 1200 ug/mL 59910-0001_23c28f55-fcde-4489-a3d1-a596046d4e40 59910-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19760101 UNAPPROVED MEDICAL GAS McDonald Welding Supply, Inc OXYGEN 99 L/100L 59915-1001_ebf42107-3f8a-4d91-91be-f346ce1961d0 59915-1001 HUMAN OTC DRUG Conju Princess BB arbutin CREAM TOPICAL 20110124 UNAPPROVED DRUG OTHER Conju Inc ADENOSINE; ARBUTIN; TITANIUM DIOXIDE .04; 2; 10.15 mL/100mL; mL/100mL; mL/100mL 59915-2001_2b7eb435-cd7d-4c7d-af88-0759ba83b017 59915-2001 HUMAN OTC DRUG Conju Princess UV Sun Block ETHYLHEXYL METHOXYCINNAMATE CREAM TOPICAL 20101218 UNAPPROVED DRUG OTHER Conju Inc AVOBENZONE; ENZACAMENE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .05; .075; .0249; .01 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 59915-3001_d98f97f2-0ec2-426f-aa41-9d7337678d87 59915-3001 HUMAN OTC DRUG Conju Princess BB arbutin CREAM TOPICAL 20101230 UNAPPROVED DRUG OTHER Conju Inc ADENOSINE; ARBUTIN; TITANIUM DIOXIDE .04; 2; 10.15 mL/100mL; mL/100mL; mL/100mL 59915-4001_5c562987-f5a5-4c7a-a02a-ba93309f5633 59915-4001 HUMAN OTC DRUG Conju Princess UV Sun Block ETHYLHEXYL METHOXYCINNAMATE CREAM TOPICAL 20101218 UNAPPROVED DRUG OTHER Conju Inc AVOBENZONE; ENZACAMENE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .05; .075; .0249; .01 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 59922-631_e6c69266-2ef1-457f-9a93-63653162351a 59922-631 HUMAN PRESCRIPTION DRUG Auryxia ferric citrate TABLET, COATED ORAL 20140917 NDA NDA205874 Keryx Biopharmaceuticals, Inc. TETRAFERRIC TRICITRATE DECAHYDRATE 210 mg/1 Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 59923-601_dce13f87-2c75-75f3-606f-acd7fe2e93cf 59923-601 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130806 ANDA ANDA077433 Areva Pharmaceuticals Inc. PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 59923-602_dce13f87-2c75-75f3-606f-acd7fe2e93cf 59923-602 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130806 ANDA ANDA077433 Areva Pharmaceuticals Inc. PAMIDRONATE DISODIUM 6 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 59923-603_dce13f87-2c75-75f3-606f-acd7fe2e93cf 59923-603 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130806 ANDA ANDA077433 Areva Pharmaceuticals Inc. PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 59923-701_58e873dd-811e-43dd-8c4b-d39848ba2df0 59923-701 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride Epirubicin Hydrochloride INJECTION INTRAVENOUS 20120716 ANDA ANDA065361 Areva Pharmaceuticals,Inc. EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 59923-702_8232464d-4799-47fa-b6c5-ceaff1924b3c 59923-702 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan INJECTION INTRAVENOUS 20120716 ANDA ANDA077219 Areva Pharmaceuticals,Inc. IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 59924-001_71d87028-0f44-430d-995f-0dc9ece860d9 59924-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19460101 UNAPPROVED MEDICAL GAS Plains Welding Supply, Inc OXYGEN 992 mL/L 59940-001_35aa8a10-6e71-47a5-8018-a66fffc12c34 59940-001 HUMAN OTC DRUG Panitrol XR Menthol CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part348 Enzyme Labs MENTHOL 4.25 g/85g 59958-100_0beb6e6e-35df-45d5-b70c-fbb13f131f40 59958-100 HUMAN OTC DRUG Naturally Nova Scotia Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20091210 OTC MONOGRAPH FINAL part333 Owen Biosciences, Inc. ALCOHOL 62 g/100g 59958-200_32c111d4-a9c1-4680-9e90-5599747bd1ff 59958-200 HUMAN OTC DRUG Anhydrous SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Owen Biosciences, Inc. TITANIUM DIOXIDE; ZINC OXIDE 10.2; 3.7 g/100g; g/100g 59958-200_54a0c38e-0c01-49bb-87e5-983d5aa2790e 59958-200 HUMAN OTC DRUG Anhydrous SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20090901 OTC MONOGRAPH FINAL part352 Owen Biosciences, Inc. TITANIUM DIOXIDE; ZINC OXIDE 10.2; 3.7 g/100g; g/100g 59958-200_b8a30ed7-e1b9-4e72-b961-ae00b9502780 59958-200 HUMAN OTC DRUG Anhydrous SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Owen Biosciences, Inc. TITANIUM DIOXIDE; ZINC OXIDE 10.2; 3.7 g/100g; g/100g 59958-201_aa382266-b329-415a-8bcc-7d140af6f0ad 59958-201 HUMAN OTC DRUG Dermaroller Anhydrous Sunscreen SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Owen Biosciences, Inc. TITANIUM DIOXIDE; ZINC OXIDE 10.2; 3.7 g/100g; g/100g 59958-202_9c3d6f3a-6650-443e-9f6d-e847d3099f7f 59958-202 HUMAN OTC DRUG SFL Sunscreen - SOL Defense SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120911 OTC MONOGRAPH NOT FINAL part352 Owen Biosciences, Inc. TITANIUM DIOXIDE; ZINC OXIDE 10.2; 3.7 g/100g; g/100g 59961-123_9377d7c1-23da-404a-9676-f50e148d9521 59961-123 HUMAN OTC DRUG SEA-CALM Meclizine HCl 25mg Chewable Tablets TABLET, CHEWABLE ORAL 20090316 OTC MONOGRAPH FINAL part336 Bellegrove MECLIZINE HYDROCHLORIDE 25 mg/1 59970-040_b93ed0aa-2efa-414c-ad54-64c1a147f53b 59970-040 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20120801 OTC MONOGRAPH FINAL part333B Navarro Discount Pharmacies,LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 59970-041_ecd98043-4c42-4e40-b218-1b53e768ee0b 59970-041 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part348 Navarro Discount Pharmacies,LLC HYDROCORTISONE 1 g/100g 59970-042_9760516b-d14e-4b18-abdd-3cfb3acf18d1 59970-042 HUMAN OTC DRUG Tolnaftate Tolnaftate CREAM TOPICAL 20120801 OTC MONOGRAPH FINAL part333C Navarro Discount Pharmacies,LLC TOLNAFTATE 1 g/100g 59970-043_6acf7e82-8f5c-4747-8fe3-6792b5a51816 59970-043 HUMAN OTC DRUG Muscle and Joint Menthol GEL TOPICAL 20121218 OTC MONOGRAPH NOT FINAL part348 Navarro Discount Pharmacies,LLC MENTHOL 2.5 g/100g 59970-044_3fe86fd2-a670-48b0-aa77-568be6234120 59970-044 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B OINTMENT TOPICAL 20120801 OTC MONOGRAPH FINAL part333B Navarro Discount Pharmacies,LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 59970-045_3c00b93e-8eb0-4ec2-98d4-eb10ccc2a792 59970-045 HUMAN OTC DRUG Diaper Rash Zinc Oxide CREAM TOPICAL 20120713 OTC MONOGRAPH FINAL part347 Navarro Discount Pharmacies,LLC ZINC OXIDE .4 g/g 59970-046_bcf6059e-1387-48b8-9776-39cb1e3480d1 59970-046 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20120801 OTC MONOGRAPH FINAL part333C Navarro Discount Pharmacies, LLC CLOTRIMAZOLE 1 g/100g 59970-048_8df2a8f3-9b55-403e-b1f7-e388e6532dc0 59970-048 HUMAN OTC DRUG Vaporizing Chest Rub Camphor, Eucalyptus Oil, Menthol GEL TOPICAL 20120815 OTC MONOGRAPH FINAL part341 Narvarro Discount Pharmarcies,LLC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 2.6; 1.2 g/100g; g/100g; g/100g 59970-049_1dba961c-c76d-4a7f-8e2d-33f791537982 59970-049 HUMAN OTC DRUG Hemorrhoidal MINERAL OIL,PETROLATUM,PHENYLEPHRINE OINTMENT TOPICAL 20120813 OTC MONOGRAPH FINAL part346 Navarro Discount Pharmacies,LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 71.9; .25 g/100g; g/100g; g/100g 59970-050_9e7416f6-23af-4ebb-8788-c1b62db35a3b 59970-050 HUMAN OTC DRUG Redness reliever tetrahydrozoline HCl LIQUID OPHTHALMIC 20120802 OTC MONOGRAPH FINAL part349 Navarro Discount Pharmacies,LLC TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 59970-051_092ea4ba-d369-4bac-ad2d-62dc5507e3ce 59970-051 HUMAN OTC DRUG Tears lubricant glycerin, hypromellose, polyethylene glycol 400 LIQUID OPHTHALMIC 20120813 OTC MONOGRAPH FINAL part349 Navarro Discount Pharmacies,LLC GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2; 2; 10 mg/mL; mg/mL; mg/mL 59970-052_e3e0787a-78ad-4215-943c-bee9048dd7e3 59970-052 HUMAN OTC DRUG Nasal Decongestant Oxymetazoline HCl SPRAY NASAL 20121026 OTC MONOGRAPH FINAL part341 Navarro Discount Pharmacies,LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 59970-053_b6158514-9d6b-4d9e-942e-736902f20509 59970-053 HUMAN OTC DRUG Saline Nasal Sodium chloride SPRAY NASAL 20110207 UNAPPROVED DRUG OTHER Navarro Discount Pharmacies, LLC SODIUM CHLORIDE 6.5 mg/mL 59970-054_2305ac99-03da-4b70-a09e-0982da1533ac 59970-054 HUMAN OTC DRUG Cold and Hot Pain Relief Menthol PATCH TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part348 Navarro Discount Pharmacies,LLC MENTHOL 400 mg/1 59970-073_9ee4cee1-85fe-4917-90ce-cb5924f8597b 59970-073 HUMAN OTC DRUG Blue Ice Pain Relieving Menthol GEL TOPICAL 20121002 OTC MONOGRAPH NOT FINAL part348 Navarro Discount Pharmacies,LLC MENTHOL .02 g/g 59970-074_4bd5270e-9e3a-45a0-9ebb-2953ac12f265 59970-074 HUMAN OTC DRUG Face and Body Sunscreen Octinoxate and Titanium dioxide LOTION TOPICAL 20130124 OTC MONOGRAPH NOT FINAL part352 Navarro Discount Pharmacies,LLC OCTINOXATE; TITANIUM DIOXIDE 7; 2.8 mg/100mg; mg/100mg 59970-075_31cda82e-11b2-4537-9f32-f54b01141bb8 59970-075 HUMAN OTC DRUG Calamine zinc oxide, ferric oxide red, pramozine HCl LOTION TOPICAL 20130603 OTC MONOGRAPH FINAL part347 Navarro Discount Pharmacies, LLC FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 80; 10; 80 mg/mL; mg/mL; mg/mL 59970-076_1ba70839-f441-46ed-90e6-007a5d1606d3 59970-076 HUMAN OTC DRUG Anti-Itch Diphenhydramine HCl GEL TOPICAL 20130118 OTC MONOGRAPH FINAL part336 Navarro Discount Pharmacies,LLC DIPHENHYDRAMINE HYDROCHLORIDE 2 g/100g 59970-077_890ed1e7-d20f-4179-97c7-9aea468f623f 59970-077 HUMAN OTC DRUG Day Time Gelcap Acetaminophen, Dextromethorphan, Phenylephrine CAPSULE, LIQUID FILLED ORAL 20130118 OTC MONOGRAPH FINAL part341 Navarro Discount Pharmacies,LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 59970-078_f9c0247e-48e0-40c8-8c96-26b081ade220 59970-078 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20130121 OTC MONOGRAPH FINAL part332 Navarro Discount Pharmacies,LLC DIMETHICONE 125 mg/1 59970-079_6511a44e-9951-42f4-8ef7-8539430a344c 59970-079 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl TABLET ORAL 20130201 OTC MONOGRAPH FINAL part338 Navarro Discount Pharmacies,LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59970-080_fee95a7c-9b47-444d-b232-82d4c4a14f52 59970-080 HUMAN OTC DRUG Cold and Hot Pain Relief Menthol PATCH TOPICAL 20120815 OTC MONOGRAPH NOT FINAL part348 Navarro Discount Pharmacies,LLC MENTHOL 400 mg/1 59970-082_8cc0bed0-b8e4-4124-a592-74d3c104f675 59970-082 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET ORAL 20130101 OTC MONOGRAPH FINAL part341 Navarro Discount Pharmacies,LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 59970-167_a5d950d3-d3e5-4127-8ab9-50d901e5f705 59970-167 HUMAN OTC DRUG Vida Mia Hand Sanitizer Aloe Vera (62%) ALCOHOL GEL TOPICAL 20140120 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 62 mL/100mL 59970-168_9756ae95-0ebc-4853-9448-1686f4062f17 59970-168 HUMAN OTC DRUG Vida Mia Hand Sanitizer Aloe Vera (62%) ALCOHOL GEL TOPICAL 20140120 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 62 mL/100mL 59970-169_49f11c4e-c0b7-4c0d-af37-490f8c2bbd34 59970-169 HUMAN OTC DRUG Vida Mia Hand Sanitizer Aloe Vera (62%) ALCOHOL GEL TOPICAL 20140120 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 62 mL/100mL 59970-170_6e5deda4-974d-4892-b71b-1022495edee0 59970-170 HUMAN OTC DRUG Vida Mia Hand Sanitizer (62%) ALCOHOL GEL TOPICAL 20140120 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 62 mL/100mL 59970-171_4f3bcfd9-0900-422e-a1c2-4d66cf103efa 59970-171 HUMAN OTC DRUG Vida Mia Hand Sanitizer ALCOHOL GEL TOPICAL 20140626 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 62 mL/100mL 59970-172_b4817e3b-51c1-45b1-b42a-4bc2aa71bd43 59970-172 HUMAN OTC DRUG Vida Mia Hand Sanitizer (62%) ALCOHOL GEL TOPICAL 20140625 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 62 mL/100mL 59970-173_addb1457-1927-4313-a600-52ea778e6008 59970-173 HUMAN OTC DRUG Vida Mia Hand Sanitizer Aloe Vera (70% v/v) ALCOHOL GEL TOPICAL 20131004 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 70 mL/100mL 59970-174_bf272411-912a-43f8-a9ed-5246001fb0c5 59970-174 HUMAN OTC DRUG Vida Mia Hand Sanitizer Aloe Vera (70% v/v) ALCOHOL GEL TOPICAL 20131010 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 70 mL/100mL 59970-175_6d71a63b-6fb7-4774-ae7d-195bc22ea226 59970-175 HUMAN OTC DRUG Vida Mia Hand Sanitizer Aloe Vera (70% v/v) ALCOHOL GEL TOPICAL 20131014 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 70 mL/100mL 59970-176_5afd5507-cd80-436c-b93c-480849097c1f 59970-176 HUMAN OTC DRUG Vida Mia Hand Sanitizer (70% v/v) ALCOHOL GEL TOPICAL 20131014 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 70 mL/100mL 59970-177_b1a9dc12-8e3a-4822-bc6d-e60654349f9b 59970-177 HUMAN OTC DRUG Vida Mia Hand Sanitizer (70% v/v) ALCOHOL GEL TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 70 mL/100mL 59970-178_e06e52c3-298c-4652-826a-722b1b5bfa27 59970-178 HUMAN OTC DRUG Vida Mia Hand Sanitizer (70% v/v) ALCOHOL GEL TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 70 mL/100mL 59970-205_4bf467b5-489b-41b7-8284-291c0cf237ce 59970-205 HUMAN OTC DRUG Vida Mia Pain Relief Aspirin, Citric Acid Monohydrate, and Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20120813 OTC MONOGRAPH FINAL part343 Navarro Discount Pharmacies, LLC ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 59972-0106_5dd99a6e-ba14-4a36-81da-a8b7aac00273 59972-0106 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19921211 UNAPPROVED MEDICAL GAS Hill Country Medical OXYGEN 99 L/100L 59973-001_8d1e32c4-dbee-48e9-bc34-4c9934d9f998 59973-001 HUMAN OTC DRUG Nurture Barrier Dimethicone CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part347 Rise Global Products DIMETHICONE 50 mg/mL 59973-002_6383b00f-5daa-4c8a-bcc3-78b4fa3a02b7 59973-002 HUMAN OTC DRUG Nurture Skin Protectant Dimethicone CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part347 Rise Global Products DIMETHICONE 10 mg/mL 59973-003_6373ace6-8939-47c3-b745-912322bcc3bd 59973-003 HUMAN OTC DRUG Nurture Skin Repair Dimethicone CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part347 Rise Global Products DIMETHICONE 1.7 mg/118mg 59983-001_27f46281-f003-4a2b-a3b9-4c7f1f7a2f2e 59983-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19790101 UNAPPROVED MEDICAL GAS Leeper Brothers, Inc. OXYGEN 99 L/100L 59985-101_ff2feb54-1609-4504-b536-903748fbc37e 59985-101 HUMAN OTC DRUG Turbo Arnica Cream Arnica montana HPUS CREAM TOPICAL 20141001 UNAPPROVED HOMEOPATHIC Homeopath Ellen's ARNICA MONTANA 30 [hp_C]/28.35g 59985-217_562c12bf-6055-46da-bff2-5e2f8e7ba7d6 59985-217 HUMAN OTC DRUG Turbo Travel Sickness Relief Tabacum, HPUS,Cocculus, HPUS,Ipecacuanha, HPUS PELLET ORAL 20140110 UNAPPROVED HOMEOPATHIC Homeopath Ellen's IPECAC; JATEORHIZA CALUMBA ROOT; TOBACCO LEAF 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 59995-001_2d55f136-c223-419d-b133-77c75978416e 59995-001 HUMAN OTC DRUG NightTime Cold and Flu ACETAMINOPHEN, DOXYLAMINE SUCCINATE HCL, DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20130319 OTC MONOGRAPH FINAL part341 Robinson Pharma, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 59995-002_954bc251-6c31-4169-b280-c28149e67d5d 59995-002 HUMAN OTC DRUG Non-Drowsy DayTime Cold and Flu Multi-Symptom Relief ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBr CAPSULE, LIQUID FILLED ORAL 20130319 OTC MONOGRAPH FINAL part341 Robinson Pharma, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 59995-003_d61af622-355a-44c3-9b74-52a2b6d76e4c 59995-003 HUMAN OTC DRUG Docusate Sodium Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130530 OTC MONOGRAPH NOT FINAL part334 Robinson Pharma, Inc. DOCUSATE SODIUM 50 mg/1 59995-004_8ca2bcf7-3d2c-4e5c-8aa0-5e0524a5f559 59995-004 HUMAN OTC DRUG Docusate Sodium Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130530 OTC MONOGRAPH NOT FINAL part334 Robinson Pharma, Inc. DOCUSATE SODIUM 100 mg/1 59995-005_3d9ae856-5842-45d3-b1ee-8444937dc605 59995-005 HUMAN OTC DRUG Docusate Sodium Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130530 OTC MONOGRAPH NOT FINAL part334 Robinson Pharma, Inc. DOCUSATE SODIUM 100 mg/1 59995-006_fa21eb48-b818-4126-9170-d3c7a4c8c28f 59995-006 HUMAN OTC DRUG DayTime Sinus Relief ACETAMINOPHEN, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED ORAL 20130612 OTC MONOGRAPH FINAL part341 Robinson Pharma, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 59995-007_3ef8a1c3-b776-4cb4-a0e7-dac61b13f1e0 59995-007 HUMAN OTC DRUG NightTime Sinus Relief ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED ORAL 20130612 OTC MONOGRAPH FINAL part341 Robinson Pharma, Inc. ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 59998-101_85328e0d-8944-40c2-ba19-5ca48d45f9f3 59998-101 HUMAN OTC DRUG BIOCENCE EUCALYPTOL THYMOL LOTION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part356 Bio-Germ Protection LLC EUCALYPTOL; THYMOL .091; .063 g/100mL; g/100mL 59998-102_4d00dd82-dd9c-4a59-bbf6-4cc31885ecde 59998-102 HUMAN OTC DRUG BIOCENCE EUCALYPTOL THYMOL SPRAY TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part356 Bio-Germ Protection LLC EUCALYPTOL; THYMOL .091; .063 g/100mL; g/100mL 59999-001_a7b341ca-a8f5-4539-b5f5-6bfc1b935699 59999-001 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20130923 OTC MONOGRAPH NOT FINAL part343 R3 Pharmaceuticals, LLC ACETAMINOPHEN 160 mg/5mL 60000-055_f6577c5b-b4e9-4320-b949-ffe5022153ba 60000-055 HUMAN OTC DRUG Moist Hand Wipes FRESH SCENT Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Ahold U.S.A., Inc. BENZALKONIUM CHLORIDE .115 g/1 60000-491_be13fb92-e29c-4b0d-8b06-e546ddb6230b 60000-491 HUMAN OTC DRUG Pure Baking Soda Baking Soda POWDER, FOR SOLUTION ORAL 20100601 20150115 OTC MONOGRAPH FINAL part331 Ahold U.S.A., Inc. SODIUM BICARBONATE 1 g/g 60055-018_b6ca0c81-8b3e-4a2d-812e-92f3016f9888 60055-018 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 Sodium Fluoride F-18 INJECTION, SOLUTION INTRAVENOUS 20101120 UNAPPROVED DRUG OTHER Triad Isotopes, Inc. SODIUM FLUORIDE F-18 475 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 60055-647_14fecfd9-fb53-4858-ba8e-62985392528c 60055-647 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F-18 INJECTION, SOLUTION INTRAVENOUS 20101120 UNAPPROVED DRUG OTHER Triad Isotopes, Inc. FLUDEOXYGLUCOSE F-18 475 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 60112-010_4e9aef16-953c-4cc0-b8a5-969aa10550af 60112-010 HUMAN OTC DRUG Inverness EAR CARE ANTISEPTIC BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333A Inverness Corp BENZALKONIUM CHLORIDE 1.2 mg/mL 60193-100_a9d424e9-4891-4035-b3f7-86caffccbf0a 60193-100 HUMAN OTC DRUG Woodwards Mycocide Clinical NS TOLNAFTATE LIQUID TOPICAL 20130424 OTC MONOGRAPH FINAL part333C Pacific World Corporation TOLNAFTATE 10 mg/mL 60193-101_dde8e58a-8b52-4404-8238-8c22a21c9daf 60193-101 HUMAN OTC DRUG Dr. Gs Clear Nail TOLNAFTATE LIQUID TOPICAL 20130424 OTC MONOGRAPH FINAL part333C Pacific World Corporation TOLNAFTATE 10 mg/mL 60193-102_e078e140-0b97-46e9-99c8-de9c5593a5bb 60193-102 HUMAN OTC DRUG Nailene Antifungal Treatment TOLNAFTATE LIQUID TOPICAL 20130424 OTC MONOGRAPH FINAL part333C Pacific World Corporation TOLNAFTATE 10 mg/mL 60193-200_18d11631-4861-4cca-857f-fecfcb9b1a90 60193-200 HUMAN OTC DRUG Woodwards HandClens Foaming Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130603 OTC MONOGRAPH NOT FINAL part333A Pacific World Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL 60193-201_42f6ae9c-7567-464a-846b-7c012fcb1a7c 60193-201 HUMAN OTC DRUG Woodwards HandClens Foaming Sanitizer Color and Fragrance Free BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130603 OTC MONOGRAPH NOT FINAL part333A Pacific World Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL 60193-202_e11b5c42-e2dc-49bc-b39d-4b8122f8e1ae 60193-202 HUMAN OTC DRUG Woodwards HandClens Foaming Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part333A Pacific World Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL 60193-203_338d52ce-d68b-4166-a155-a4c3c4c10a86 60193-203 HUMAN OTC DRUG WOODWARDS HANDCLENS FOAMING SANITIZER COLOR AND FRAGRANCE FREE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part333A Pacific World Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL 60193-400_0d3afc45-2982-40b5-ac28-4f616a6cddae 60193-400 HUMAN OTC DRUG Ped X Callus Removers, Medicated Salicylic acid PATCH TOPICAL 20070901 OTC MONOGRAPH FINAL part358F Pacific World Corporation SALICYLIC ACID 4 mg/1 60193-401_0d3afc45-2982-40b5-ac28-4f616a6cddae 60193-401 HUMAN OTC DRUG Ped X Callus Removers, Extra Thick Medicated Salicylic acid PATCH TOPICAL 20070901 OTC MONOGRAPH FINAL part358F Pacific World Corporation SALICYLIC ACID 4 mg/1 60193-402_aae0d494-17f3-45a5-b6e6-01531fd25ade 60193-402 HUMAN OTC DRUG Ped X Corn Removers, Medicated Salicylic acid PATCH TOPICAL 20070901 OTC MONOGRAPH FINAL part358F Pacific World Corporation SALICYLIC ACID 4 mg/1 60193-500_c6fe91e3-7877-4b1e-877c-607decd2da59 60193-500 HUMAN OTC DRUG Trim Men Styptic Pencil Aluminum sulfate STICK TOPICAL 20021101 OTC MONOGRAPH FINAL part347 Pacific World Corporation ALUMINUM SULFATE 5.6 g/10g 60193-501_89d1af23-7c8a-4c3d-b009-9715d270e1d1 60193-501 HUMAN OTC DRUG HIS Styptic Pencil Aluminum sulfate STICK TOPICAL 20021101 OTC MONOGRAPH FINAL part347 Pacific World Corporation ALUMINUM SULFATE 5.6 g/10g 60207-001_c89ffcbb-ad69-42a5-87c7-eec980be394b 60207-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Apple Homecare Associates, Inc. OXYGEN 99 L/100L 60215-411_c90299c9-645e-4784-bae6-b67271969c9e 60215-411 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F18 INJECTION INTRAVENOUS 20111206 ANDA ANDA203246 The University of Texas MD Anderson Cancer Center FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 60215-412_92a84cef-4ac7-45a3-9ea6-ad9b6406ecbc 60215-412 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F-18 INJECTION INTRAVENOUS 20111216 ANDA ANDA203247 University of Texas MD Anderson Cancer Center SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 60232-2282_f10706a0-bfa2-434e-9b72-00d3e8c94f9b 60232-2282 HUMAN OTC DRUG EltaMD UV Shield SPF 45 Zinc Oxide, Octinoxate LOTION TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products OCTINOXATE; ZINC OXIDE 75; 90 g/1000g; g/1000g 60232-2283_18401edf-1650-4def-a424-cc1471ad37f6 60232-2283 HUMAN OTC DRUG EltaMD UV Facial SPF 30 Zinc Oxide, Octinoxate LOTION TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products OCTINOXATE; ZINC OXIDE 75; 70 g/1000g; g/1000g 60232-2286_a0a4b0b2-8179-4781-a248-4665f8ce2288 60232-2286 HUMAN OTC DRUG EltaMD UV SPF 30 Zinc Oxide, Octinoxate LOTION TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products OCTINOXATE; ZINC OXIDE 75; 70 g/1000g; g/1000g 60232-2289_f95b6205-2e4a-4d52-b2e7-95b6cc238e5a 60232-2289 HUMAN OTC DRUG EltaMD UV Daily SPF 40 Zinc Oxide, Octinoxate LOTION TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products OCTINOXATE; ZINC OXIDE 75; 90 g/1000g; g/1000g 60232-2290_3cac5881-5e17-47f2-a7f1-439c12e3dab0 60232-2290 HUMAN OTC DRUG EltaMD UV Sport SPF 50 Zinc Oxide, Octinoxate, Octisalate LOTION TOPICAL 20090629 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 50; 90 g/1000g; g/1000g; g/1000g 60232-2500_f4b677db-2717-4446-a0f6-4dbcb8e22a6d 60232-2500 HUMAN OTC DRUG Elta MD UV Clear SPF46 zinc oxide and octinoxate lotion LOTION TOPICAL 20090701 OTC MONOGRAPH NOT FINAL part352 Swiss American Products,Inc. OCTINOXATE; ZINC OXIDE 75; 90 g/1000g; g/1000g 60232-2510_e874cc96-da2c-4a9a-978e-52ddd9699bc9 60232-2510 HUMAN OTC DRUG EltaMD UV Lip Balm Lip Balm with Sunscreen CREAM TOPICAL 20121127 OTC MONOGRAPH FINAL part352 Swiss American Products OCTINOXATE; ZINC OXIDE 75; 50 g/1000g; g/1000g 60232-2578_8d61cd67-ec0f-4d7c-958b-8e6bd7d138de 60232-2578 HUMAN OTC DRUG EltaMD UV PhysicalSPF 41 SPF 41 EltaMD UV Physical SPF 41 LOTION TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products TITANIUM DIOXIDE; ZINC OXIDE 70; 90 g/1000g; g/1000g 60232-2582_9c347a1a-f20c-4a0a-bf70-596614b4bd43 60232-2582 HUMAN OTC DRUG Elta MD UV Pure SPF47 titanium dioxide and zinc oxide lotion LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 Swiss American Products, Inc. TITANIUM DIOXIDE; ZINC OXIDE 55; 100 g/1000g; g/1000g 60232-2585_79af99c3-2738-494f-9d92-04c8aa606a91 60232-2585 HUMAN OTC DRUG Elta MD UV SPF46 SPF46 zinc oxide and octinoxate sunscreen SPRAY TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 Swiss American Products, Inc. OCTINOXATE; ZINC OXIDE 75; 93 g/1000g; g/1000g 60232-2587_a82f310d-4a9d-469f-b5ae-65c8ea0c191c 60232-2587 HUMAN OTC DRUG Elta MD UV Aero SPF45 zinc oxide and octinoxate aerosol AEROSOL, SPRAY TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 Swiss American Products, Inc. OCTINOXATE; ZINC OXIDE 75; 93 g/1000g; g/1000g 60232-3400_d3a932f5-339c-442e-b3be-447ec0e89375 60232-3400 HUMAN OTC DRUG Elta Tar Coal Tar CREAM TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part358H Swiss-American Products COAL TAR 20 g/1000g 60232-6200_ac940d75-2d95-4235-8746-d75ead219afb 60232-6200 HUMAN OTC DRUG Elta Block SPF 32 Zinc Oxide, Octinoxate, Octisalate LOTION TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products OCTINOXATE; ZINC OXIDE 75; 70 g/1000g; g/1000g 60232-6500_7879ca15-daf4-4b64-a43e-6ba3e73847ad 60232-6500 HUMAN OTC DRUG Elta Block SPF 30 Waterproof Zinc Oxide, Octinoxate, Octisalate LOTION TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 50; 45 g/1000g; g/1000g; g/1000g 60232-7600_37872aa3-c1a7-4b00-a27a-1b4e5ae5df36 60232-7600 HUMAN OTC DRUG Elta Lite Tar Coal Tar LOTION TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part358H Swiss-American Products COAL TAR 20 g/1000g 60232-8200_41596b93-d71b-4d9b-b72a-f99d09a47418 60232-8200 HUMAN OTC DRUG Elta Seal Zinc Oxide Skin Protectant CREAM TOPICAL 20121201 OTC MONOGRAPH FINAL part347 Swiss American Products ZINC OXIDE 60 g/1000g 60232-8577_79102cf1-4999-44a4-b1c8-5acb104f0677 60232-8577 HUMAN OTC DRUG Elta Trivase Miconazole Nitrate CREAM TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part333C Swiss-American Products MICONAZOLE NITRATE 20 g/1000g 60232-8581_fadc8e53-03c8-41c0-bc0a-b9549a8b8719 60232-8581 HUMAN OTC DRUG Elta Dermavase Zinc Oxide CREAM TOPICAL 20090630 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products ZINC OXIDE 75 g/1000g 60258-001_837576d9-13aa-44b1-96b9-412dd1d2c749 60258-001 HUMAN PRESCRIPTION DRUG Cytra-2 Sodium Citrate and Citric Acid LIQUID ORAL 20081001 UNAPPROVED DRUG OTHER Cypress Pharmaceutical, Inc. CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 334; 500 mg/5mL; mg/5mL 60258-002_fef881b8-af75-4c8c-9acd-2b2d10a5e385 60258-002 HUMAN PRESCRIPTION DRUG CYTRA 3 Potassium Citrate Monohydrate, Sodium Citrate Dihydrate, Citric Acid Monohydrate SYRUP ORAL 20080729 UNAPPROVED DRUG OTHER Cypress Pharmaceuticals, Inc CITRIC ACID MONOHYDRATE; POTASSIUM CITRATE; SODIUM CITRATE 334; 550; 500 mg/5mL; mg/5mL; mg/5mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 60258-003_64da7134-9616-426f-90d5-27eab250cb9e 60258-003 HUMAN PRESCRIPTION DRUG Cytra-K Potassium Citrate and Citric Acid LIQUID ORAL 20080930 UNAPPROVED DRUG OTHER Cypress Pharmaceutical, Inc. CITRIC ACID MONOHYDRATE; POTASSIUM CITRATE 334; 1100 mg/5mL; mg/5mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 60258-005_8dfd75b8-c395-4f31-99b3-c6a3ee700254 60258-005 HUMAN PRESCRIPTION DRUG Cytra-K Cystrals Potassium Citrate and Citric Acid GRANULE, FOR SOLUTION ORAL 20030501 UNAPPROVED DRUG OTHER Cypress Pharmaceutical, Inc. CITRIC ACID MONOHYDRATE; POTASSIUM CITRATE 1.002; 3.3 g/1; g/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 60258-050_8c08e86b-b17f-42e1-9e83-9aa8302c0724 60258-050 HUMAN OTC DRUG APAP 500 Acetaminophen Oral Solution LIQUID ORAL 19950615 OTC MONOGRAPH NOT FINAL part343 Cypress Pharmaceutical, Inc. ACETAMINOPHEN 500 mg/5mL 60258-150_0db352d2-2ce7-4788-9fdb-e9082df92130 60258-150 HUMAN PRESCRIPTION DRUG SF 5000 Plus 1.1% Sodium Fluoride Prescription Dental Cream CREAM DENTAL 19991112 UNAPPROVED DRUG OTHER Cypress Pharmaceutical, Inc. SODIUM FLUORIDE 11 mg/g 60258-151_8eb69581-d64e-4a3b-b9c1-c95e34e3d98f 60258-151 HUMAN PRESCRIPTION DRUG SF 1.1% Sodium Fluoride GEL DENTAL 19991201 UNAPPROVED DRUG OTHER Cypress Pharmaceutical, Inc. SODIUM FLUORIDE 11 mg/g 60258-158_d5574e51-a31c-48c0-869b-af3a06274a9c 60258-158 HUMAN PRESCRIPTION DRUG Neutral Sodium Fluoride 0.2% Dental Rinse sodium fluoride RINSE ORAL 20060801 UNAPPROVED OTHER Cypress Pharmaceutical, Inc. SODIUM FLUORIDE 9 mg/10mL 60258-159_b00dca4f-9c0c-4531-95fa-89fa0992247c 60258-159 HUMAN PRESCRIPTION DRUG Stannous Fluoride 0.63% Stannous Fluoride RINSE ORAL 20000316 UNAPPROVED DRUG OTHER Cypress Pharmaceutical, Inc. STANNOUS FLUORIDE 6.3 mg/g 60258-162_30e18528-9922-4db5-bd20-f31d9691c2e9 60258-162 HUMAN PRESCRIPTION DRUG Renal Caps Dialysis/Stress Vitamin Supplement ASCORBIC ACID, THIAMINE MONONITRATE,RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CAPSULE, LIQUID FILLED ORAL 20021031 UNAPPROVED OTHER Cypress Pharmaceutical, Inc. ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE 100; 150000; 5; 6000; 1; 20; 10; 1.7; 1.5 mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 60258-189_6e6695f1-29e6-436b-9994-42dd35bc8dc5 60258-189 HUMAN PRESCRIPTION DRUG FerroGels Forte Ascorbic acid, folic acid, cyanocobalamin, and ferrous fumarate CAPSULE, LIQUID FILLED ORAL 20020801 UNAPPROVED OTHER Cypress Pharmaceutical, Inc. ASCORBIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID 60; 10000; 151; 1 mg/1; ng/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 60258-190_488af820-9137-4240-b3b0-432a6adc95ab 60258-190 HUMAN PRESCRIPTION DRUG Prenatabs FA Beta carotene, cholecalciferol, dl-alpha tocopheryl acetate, ascorbic acid, folic acid, thiamin mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, calcium carbonate, potas TABLET, FILM COATED ORAL 19990723 UNAPPROVED OTHER Cypress Pharmaceutical, Inc. ASCORBIC ACID; BETA CAROTENE; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC 120; 4000; 200; 400; 8; 29; 1; 20; 150; 3; 3; 3; 15 mg/1; [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 60258-201_9eb64a04-92f5-48e5-ae05-8dc3d1225784 60258-201 HUMAN OTC DRUG Hist-PSE Pseudoephedrine Hydrochloride and Triprolidine Hydrochloride LIQUID ORAL 20100416 OTC MONOGRAPH FINAL part341 Cypress Pharmaceutical, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 10; .938 mg/mL; mg/mL 60258-520_9f0e4125-17d1-47d0-8c89-fc02645310dc 60258-520 HUMAN OTC DRUG CORFEN DM Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20110608 OTC MONOGRAPH FINAL part341 Cypress Pharmaceutical, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 15; 10 mg/5mL; mg/5mL; mg/5mL 60258-521_8deace9b-033d-4caf-8c6e-8a9cf510e0a4 60258-521 HUMAN OTC DRUG De-Chlor DM Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Chlorpheniramine Maleate LIQUID ORAL 20110709 OTC MONOGRAPH FINAL part341 Cypress Pharmaceutical, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 15; 10 mg/5mL; mg/5mL; mg/5mL 60258-525_1c55f0ab-6120-4f21-a071-0a9983e9328f 60258-525 HUMAN OTC DRUG Neutrahist Pediatric Chlorpheniramine Maleate, Pseudoephedrine Hydrochloride LIQUID ORAL 20110613 OTC MONOGRAPH FINAL part341 Cypress Pharmaceutical, Inc. CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE .8; 9 mg/mL; mg/mL 60258-526_514fdc1a-9981-4ed3-96aa-a9c79bf849ea 60258-526 HUMAN OTC DRUG Neutrahist PDX Drops Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride LIQUID ORAL 20110906 OTC MONOGRAPH FINAL part341 Cypress Pharmaceutical, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE .8; 3; 9 mg/mL; mg/mL; mg/mL 60258-530_814a61a2-90f7-4656-a01b-3ae8c1fe488d 60258-530 HUMAN OTC DRUG Dex-Tuss Codeine Phosphate, Guaifenesin LIQUID ORAL 20110728 OTC MONOGRAPH FINAL part341 Cypress Pharmaceutical, Inc. CODEINE PHOSPHATE; GUAIFENESIN 10; 300 mg/5mL; mg/5mL CV 60258-801_1b369677-db8a-4a89-8d7b-8e32ca34ac1e 60258-801 HUMAN PRESCRIPTION DRUG HYOSCYAMINE SULFATE Hyoscyamine Sulfate ELIXIR ORAL 20081121 UNAPPROVED DRUG OTHER Cypress Pharmaceutical, Inc. HYOSCYAMINE SULFATE .125 mg/5mL 60258-802_56517932-dafa-4c44-a502-8b805e8cd571 60258-802 HUMAN PRESCRIPTION DRUG HYOSCYAMINE SULFATE Hyoscyamine Sulfate SOLUTION/ DROPS ORAL 20081230 UNAPPROVED DRUG OTHER Cypress Pharmaceutical, Inc. HYOSCYAMINE SULFATE .125 mg/mL 60258-850_2e6bac74-cd4f-4429-a8d3-564eefbf9148 60258-850 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20100615 ANDA ANDA040644 Cypress Pharmaceutical, Inc. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 60258-858_e037c560-f0f0-421b-bb58-a064c5b241f3 60258-858 HUMAN PRESCRIPTION DRUG Epinastine HCl epinastine hydrochloride SOLUTION OPHTHALMIC 20110502 ANDA ANDA090870 Cypress Pharmaceutical, Inc. EPINASTINE HYDROCHLORIDE .5 mg/mL Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 60258-860_e25f4b3f-3f98-4346-b880-b50757c61eab 60258-860 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SYRUP ORAL 20081006 ANDA ANDA078488 Cypress Pharmaceutical, Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 60258-865_b99e3cbf-6e8e-45f7-9ccb-8183c4cb5d84 60258-865 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090116 ANDA ANDA079120 Cypress Pharmaceutical, Inc. LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60258-866_1374f5ee-837e-4b4b-afe8-b236bca7b2ec 60258-866 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, COATED ORAL 20100628 ANDA ANDA078944 Cypress Pharmaceutical, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 60258-870_8ae36e5e-f004-4c01-a2b7-d5cbd755ec54 60258-870 HUMAN PRESCRIPTION DRUG Carbinoxamine Maleate Carbinoxamine Maleate TABLET ORAL 20100823 ANDA ANDA090417 Cypress Pharmaceutical, Inc. CARBINOXAMINE MALEATE 4 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 60258-876_23dc5184-97af-43ab-a7d5-39b9f4ac3b93 60258-876 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine HCl hydrocodone bitartrate, chlorpheniramine maleate, pseudoephedrine hydrochloride SOLUTION ORAL 20140109 NDA NDA022439 Cypress Pharmaceutical, Inc. CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 5; 60 mg/5mL; mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII 60258-890_cb0460b9-a3f2-4228-8120-caa3447ab196 60258-890 HUMAN PRESCRIPTION DRUG Mefenamic Acid Mefenamic Acid CAPSULE ORAL 20130603 ANDA ANDA090359 Cypress Pharmaceutical, Inc. MEFENAMIC ACID 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60258-955_32269fb0-69dd-42f9-bad6-5aabd6921e93 60258-955 HUMAN OTC DRUG DOCUSATE SODIUM Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000801 OTC MONOGRAPH NOT FINAL part334 Cypress Pharmaceuticals, Inc. DOCUSATE SODIUM 100 mg/1 60267-311_1cfdd158-25f4-45e0-9188-4cf4f345667e 60267-311 HUMAN PRESCRIPTION DRUG Sodium Nitrite Sodium Nitrite INJECTION, SOLUTION INTRAVENOUS 20120214 NDA NDA203922 Hope Pharmaceuticals SODIUM NITRITE 30 mg/mL 60267-705_f9a0cd17-ebd9-4c85-a130-8a7dafdb1255 60267-705 HUMAN PRESCRIPTION DRUG Sodium Thiosulfate Sodium Thiosulfate INJECTION, SOLUTION INTRAVENOUS 20120214 NDA NDA203923 Hope Pharmaceuticals SODIUM THIOSULFATE 250 mg/mL 60267-812_d8dff852-99cb-47e2-9c48-b7c81e90ec6e 60267-812 HUMAN PRESCRIPTION DRUG NITHIODOTE Sodium Nitrite and Sodium Thiosulfate KIT 20110114 NDA NDA201444 Hope Pharmaceuticals 60268-0001_cf5df580-de27-4b55-b881-40d2ae223978 60268-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990601 UNAPPROVED MEDICAL GAS Gammie Home Care, Inc. OXYGEN 99 L/100L 60289-015_65180c92-644f-4bbc-b2cc-d790c84410f9 60289-015 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS Mineral Suncare spf 15 OCTOCRYLENE SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 AHAVA - Dead Sea Laboratories Ltd. AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 6.25; 2.5; 7.5; 20; 3.14 mL/250mL; mL/250mL; mL/250mL; mL/250mL; mL/250mL 60289-030_5793e66f-b21b-45ac-ba77-43d1ddb45acf 60289-030 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS Mineral Suncare spf 30 OCTOCRYLENE SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 AHAVA - Dead Sea Laboratories Ltd. AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 2.5; 5; 25; 3.8 mL/250mL; mL/250mL; mL/250mL; mL/250mL; mL/250mL 60289-031_826a5dcf-25d7-4bc0-8565-d90f97805be4 60289-031 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS Mineral Suncare spf 30 OCTOCRYLENE CREAM TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 AHAVA - Dead Sea Laboratories Ltd. AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 2.5; 5; 25; 3.8 mL/250mL; mL/250mL; mL/250mL; mL/250mL; mL/250mL 60289-050_dd4b7f02-04d9-47da-8145-b41440ca0978 60289-050 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS Mineral Suncare spf 50 OCTOCRYLENE CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 AHAVA - Dead Sea Laboratories Ltd. AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 2.5; 12.5; 25; 12.5 mL/250mL; mL/250mL; mL/250mL; mL/250mL; mL/250mL 60289-051_450aeec9-2408-42fc-8929-05ae5825e066 60289-051 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS Mineral Suncare spf 50 face OCTOCRYLENE CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 AHAVA - Dead Sea Laboratories Ltd. AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 1.8; .6; 3; 6; 3 mL/60mL; mL/60mL; mL/60mL; mL/60mL; mL/60mL 60289-236_d2430dc8-4588-4f6b-825f-acc071827f01 60289-236 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS TIME TO HYDRATE ESSENTIAL MOISTURIZING BROAD SPECTRUM SPF15 Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20130201 OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 2.5; 1.355 g/50mL; g/50mL; g/50mL 60289-238_cabe05ad-aba3-417c-b3fc-59fbe788f907 60289-238 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS TIME TO HYDRATE ESSENTIAL LIP BALM BROAD SPECTRUM SPF15 Avobenzone, Octisalate, and Octocrylene CREAM TOPICAL 20130808 OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE .45; .75; .411 g/15mL; g/15mL; g/15mL 60289-247_70686933-1631-4e9d-b879-85a5d49b9dd1 60289-247 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS AGE CONTROL EVEN TONE MOISTURIZER BROAD SPECTRUM SPF20 Avobenzone, Octisalate, Homosalate, and Octocrylene CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.5; 2.5; 2.5; 1.35 g/50mL; g/50mL; g/50mL; g/50mL 60289-280_59891430-d832-479d-879e-2d9fb932cb7d 60289-280 HUMAN OTC DRUG AHAVA AGE PERFECTING BROAD SPECTRUM SPF15 Avobenzone, Octisalate, and Octocrylene CREAM TOPICAL 20131115 OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 2.25; 3.75; 2.05 g/75mL; g/75mL; g/75mL 60289-281_643d2289-d701-4710-bbc4-f39a13a92c85 60289-281 HUMAN OTC DRUG AHAVA AGE PERFECTING BROAD SPECTRUM SPF15 Avobenzone, Octisalate, and Octocrylene CREAM TOPICAL 20131115 OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 2.25; 3.75; 2.05 g/75mL; g/75mL; g/75mL 60289-282_3185c69d-9b09-42b8-9dcc-57206a8cbc1d 60289-282 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS TIME TO ENERGIZE AGE CONTROL MOISTURIZING BROAD SPECTRUM SPF15 Avobenzone, Octisalate, and Octocrylene CREAM TOPICAL 20130725 OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 27 mg/mL; mg/mL; mg/mL 60306-115_390a5e15-64db-4873-b109-bc584f243923 60306-115 HUMAN OTC DRUG Brace Relief Benzocaine GEL ORAL 20050103 OTC MONOGRAPH FINAL part333B InfaLab,Inc BENZOCAINE 9 mg/mL 60314-1001_e21b68b7-9644-4c60-ae03-5171422215b4 60314-1001 HUMAN OTC DRUG Slim 2 CIANIDANOL POWDER ORAL 20110915 UNAPPROVED DRUG OTHER Bionutrigen Co., Ltd. CIANIDANOL .45 g/100g 60314-2001_33a79df4-2309-4dc2-bee5-f12d8b9d3d38 60314-2001 HUMAN OTC DRUG Liver supplement PHENOL POWDER ORAL 20110915 UNAPPROVED DRUG OTHER Bionutrigen Co., Ltd. PHENOL .8 g/100g 60317-123_6bd7c19e-73cc-7905-3fc8-cac5a42c8fec 60317-123 HUMAN PRESCRIPTION DRUG Liquid Oxygen Liquid Oxygen GAS RESPIRATORY (INHALATION) 19900810 UNAPPROVED MEDICAL GAS Pedi Stat Inc. OXYGEN 995 mL/L 60319-1001_95ed2181-d9d7-42cc-9658-660ff7a91d19 60319-1001 HUMAN OTC DRUG Premium Whitening HYDROGEN PEROXIDE GEL, DENTIFRICE DENTAL 20110913 UNAPPROVED DRUG OTHER Hankuk Bowonbio Co., Ltd HYDROGEN PEROXIDE 35 mL/100mL 60319-2001_0c6bafe0-d8b1-4266-9d0a-51a4f48944dc 60319-2001 HUMAN OTC DRUG Noble S Plus SILVER PASTE, DENTIFRICE DENTAL 20110919 UNAPPROVED DRUG OTHER Hankuk Bowonbio Co., Ltd SILVER .7 g/100g 60319-3001_54d953fc-a218-4108-8119-5fc5a18aa5f9 60319-3001 HUMAN OTC DRUG Noble G Plus XYLITOL PASTE, DENTIFRICE DENTAL 20121130 UNAPPROVED DRUG OTHER Hankuk Bowonbio Co., Ltd XYLITOL .7 g/100g 60319-4001_249601f7-e1e1-48dd-9ce4-6d9f1310151b 60319-4001 HUMAN OTC DRUG Noble 1 Plus XYLITOL POWDER, DENTIFRICE DENTAL 20121130 UNAPPROVED DRUG OTHER Hankuk Bowonbio Co., Ltd XYLITOL .7 g/100g 60344-1001_a37f95b0-a39d-423b-9fdd-e4f41892bd0f 60344-1001 HUMAN OTC DRUG TAMNAMO ESSENTIAL HAIR GLYCERIN SHAMPOO TOPICAL 20130826 OTC MONOGRAPH FINAL part347 Tamnamo Co., Ltd GLYCERIN .04 g/mL 60344-2001_7b8786b3-ddb7-4f0b-9939-2f10fb323844 60344-2001 HUMAN OTC DRUG TAMNAMO PLUS VITAL HAIR GLYCERIN SHAMPOO TOPICAL 20130826 OTC MONOGRAPH FINAL part347 Tamnamo Co., Ltd GLYCERIN .01 g/mL 60344-3001_3d1f1e51-fa18-40de-a890-9aa093d104f0 60344-3001 HUMAN OTC DRUG TAMNAMO ESSENTIAL HAIR TONIC ASIAN GINSENG LIQUID TOPICAL 20130812 UNAPPROVED DRUG OTHER Tamnamo Co., Ltd ASIAN GINSENG .03 mg/mL 60344-4001_edf62bec-8450-44cc-a21d-f3bf7d41da86 60344-4001 HUMAN OTC DRUG TAMNAMO PLUS VITAL HAIR ASIAN GINSENG SOLUTION TOPICAL 20130812 UNAPPROVED DRUG OTHER Tamnamo Co., Ltd ASIAN GINSENG .03 mg/mL 60344-5001_b6f3309b-49e0-474d-86ef-2be8cbd341ea 60344-5001 HUMAN OTC DRUG Queen Perfume Hair GLYCERIN SHAMPOO TOPICAL 20140130 OTC MONOGRAPH FINAL part347 Tamnamo Co., Ltd GLYCERIN .02 mg/mL 60344-6001_ca52cb6a-4b3f-4b34-965d-36e7b3efd12d 60344-6001 HUMAN OTC DRUG Queen Perfume Hair Conditioner ALLANTOIN LIQUID TOPICAL 20140130 OTC MONOGRAPH FINAL part347 Tamnamo Co., Ltd ALLANTOIN .02 mg/mL 60344-7001_606fe294-7d5c-4cce-965e-7cbbda19fae9 60344-7001 HUMAN OTC DRUG Tamnamo Vital Hair Treatment ALLANTOIN LIQUID TOPICAL 20140130 OTC MONOGRAPH FINAL part347 Tamnamo Co., Ltd ALLANTOIN .002 g/mL 60367-001_c49ffe21-92e7-4fad-ab14-f562eb18ed76 60367-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19750101 UNAPPROVED MEDICAL GAS County Welding Supply Co. OXYGEN 998 mL/L 60367-002_1aa9dbee-5ea0-49c3-aa63-41a599a19f26 60367-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19750101 UNAPPROVED MEDICAL GAS County Welding Supply Co. OXYGEN 998 mL/L 60371-339_94f4ab8d-8b5b-47da-8457-b0c2e7206489 60371-339 HUMAN OTC DRUG SafetyMAXX Mint Flavor SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20111115 OTC MONOGRAPH FINAL part355 FSi, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 60371-344_11fc8a8a-b455-4c65-978a-914282ee1993 60371-344 HUMAN OTC DRUG SafetyMAXX Mint Flavor SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20111115 OTC MONOGRAPH FINAL part355 FSi, Inc. SODIUM FLUORIDE .22 g/100g 60379-100_089e94ff-b9b9-5fa5-e054-00144ff88e88 60379-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070601 UNAPPROVED MEDICAL GAS Providence Home Medical Equipment OXYGEN 1 L/L 60429-012_6b622287-7e28-4a21-9ace-4bbd7a5596b4 60429-012 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20120920 ANDA ANDA075677 Golden State Medical Supply, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 60429-015_105133d9-2991-4dd2-8d99-beb81aed8aad 60429-015 HUMAN PRESCRIPTION DRUG Cortisone Acetate Cortisone Acetate TABLET ORAL 19720613 ANDA ANDA080776 Golden State Medical Supply, Inc. CORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60429-016_3a0a6ef4-fb2c-47be-82d7-d2675059c45b 60429-016 HUMAN PRESCRIPTION DRUG Mycophenolic Acid Mycophenolic Acid TABLET, DELAYED RELEASE ORAL 20141013 ANDA ANDA091558 Golden State Medical Supply, Inc. MYCOPHENOLATE SODIUM 180 mg/1 Antimetabolite Immunosuppressant [EPC] 60429-017_3a0a6ef4-fb2c-47be-82d7-d2675059c45b 60429-017 HUMAN PRESCRIPTION DRUG Mycophenolic Acid Mycophenolic Acid TABLET, DELAYED RELEASE ORAL 20141013 ANDA ANDA091558 Golden State Medical Supply, Inc. MYCOPHENOLATE SODIUM 360 mg/1 Antimetabolite Immunosuppressant [EPC] 60429-018_08c7b4e2-6f7a-4734-9f42-246122fec449 60429-018 HUMAN PRESCRIPTION DRUG Benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Golden State Medical Supply, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 60429-019_70f4be03-3b4d-49d8-8be7-a04e2b615c93 60429-019 HUMAN PRESCRIPTION DRUG SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE CAPSULE ORAL 20061104 ANDA ANDA075352 Golden State Medical Supply, Inc. SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] 60429-020_a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b7 60429-020 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 20090520 ANDA ANDA075319 Golden State Medical Supply, Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 60429-021_401b325f-f844-42b1-af8b-d260af12328d 60429-021 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20090715 ANDA ANDA062884 Golden State Medical Supply, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 60429-022_401b325f-f844-42b1-af8b-d260af12328d 60429-022 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20090715 ANDA ANDA062881 Golden State Medical Supply, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 60429-023_20491908-3ede-4858-b3f9-aa0f737b7efc 60429-023 HUMAN PRESCRIPTION DRUG Ampicillin Trihydrate Ampicillin Trihydrate CAPSULE ORAL 19880225 ANDA ANDA062883 Golden State Medical Supply, Inc. AMPICILLIN TRIHYDRATE 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 60429-024_20491908-3ede-4858-b3f9-aa0f737b7efc 60429-024 HUMAN PRESCRIPTION DRUG Ampicillin Trihydrate Ampicillin Trihydrate CAPSULE ORAL 19880225 ANDA ANDA062882 Golden State Medical Supply, Inc. AMPICILLIN TRIHYDRATE 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 60429-025_f4f06c00-9024-4e04-a882-0da2b24d8ff7 60429-025 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20140220 ANDA ANDA073457 Golden State Medical Supply, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60429-026_f4f06c00-9024-4e04-a882-0da2b24d8ff7 60429-026 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20140220 ANDA ANDA073457 Golden State Medical Supply, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60429-027_f4f06c00-9024-4e04-a882-0da2b24d8ff7 60429-027 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20140220 ANDA ANDA073457 Golden State Medical Supply, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60429-028_08c7b4e2-6f7a-4734-9f42-246122fec449 60429-028 HUMAN PRESCRIPTION DRUG Benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 Golden State Medical Supply, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 60429-029_064441bf-9088-4a07-b4ff-ac0e00147690 60429-029 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 20170330 ANDA ANDA074505 Golden State Medical Supply, Inc. CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60429-030_064441bf-9088-4a07-b4ff-ac0e00147690 60429-030 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Golden State Medical Supply, Inc. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60429-031_064441bf-9088-4a07-b4ff-ac0e00147690 60429-031 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Golden State Medical Supply, Inc. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60429-032_9fca7d59-dd9e-4fd8-bf34-e2f7e5a36801 60429-032 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20140307 ANDA ANDA075948 Golden State Medical Supply, Inc. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 60429-033_12b35b09-5630-4720-a28a-eb8a395ee013 60429-033 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE AcetaZOLAMIDE TABLET ORAL 19970528 ANDA ANDA040195 Golden State Medical Supply, Inc. ACETAZOLAMIDE 125 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 60429-034_12b35b09-5630-4720-a28a-eb8a395ee013 60429-034 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE AcetaZOLAMIDE TABLET ORAL 19970528 ANDA ANDA040195 Golden State Medical Supply, Inc. ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 60429-035_807ddef4-a288-45bf-8757-d17f1746fa96 60429-035 HUMAN PRESCRIPTION DRUG PRIMAQUINE PHOSPHATE PRIMAQUINE TABLET, FILM COATED ORAL 20140508 ANDA ANDA204476 Golden State Medical Supply, Inc. PRIMAQUINE PHOSPHATE 15 mg/1 Antimalarial [EPC] 60429-036_e2447895-d026-4829-a942-50c670d55cb2 60429-036 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110128 ANDA ANDA062702 Golden State Medical Supply, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60429-037_e2447895-d026-4829-a942-50c670d55cb2 60429-037 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110128 ANDA ANDA062702 Golden State Medical Supply, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60429-038_2f528bdb-66c3-45d4-9d37-63c093bfd5b5 60429-038 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA078745 Golden State Medical Supply, Inc. RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60429-039_2f528bdb-66c3-45d4-9d37-63c093bfd5b5 60429-039 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA078745 Golden State Medical Supply, Inc. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60429-040_2f528bdb-66c3-45d4-9d37-63c093bfd5b5 60429-040 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA078745 Golden State Medical Supply, Inc. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60429-041_2f528bdb-66c3-45d4-9d37-63c093bfd5b5 60429-041 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA078745 Golden State Medical Supply, Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60429-044_f058b884-c726-4e19-b019-f9f885a028ab 60429-044 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 Golden State Medical Supply, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60429-045_f058b884-c726-4e19-b019-f9f885a028ab 60429-045 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 Golden State Medical Supply, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60429-046_f058b884-c726-4e19-b019-f9f885a028ab 60429-046 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 Golden State Medical Supply, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60429-052_642f3822-68a2-456e-8fb5-b5fe41fe8c50 60429-052 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20060203 ANDA ANDA071611 Golden State Medical Supply, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 60429-057_7a7e69c1-6eea-4f27-b2ed-3e5fb176fdae 60429-057 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20140812 ANDA ANDA075185 Golden State Medical Supply, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-058_7a7e69c1-6eea-4f27-b2ed-3e5fb176fdae 60429-058 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20140812 ANDA ANDA075185 Golden State Medical Supply, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-061_7f7e72b0-13ab-49cf-9ee5-11085e801651 60429-061 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20130411 ANDA ANDA078069 Golden State Medical Supply OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-062_7f7e72b0-13ab-49cf-9ee5-11085e801651 60429-062 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20130411 ANDA ANDA078069 Golden State Medical Supply OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-063_7f7e72b0-13ab-49cf-9ee5-11085e801651 60429-063 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20130411 ANDA ANDA078069 Golden State Medical Supply OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-064_f09ab4cf-ec4c-4ae4-b0bb-38847c766899 60429-064 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20081215 ANDA ANDA090255 Golden State Medical Supply, Inc. HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 60429-065_f09ab4cf-ec4c-4ae4-b0bb-38847c766899 60429-065 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20081215 ANDA ANDA090255 Golden State Medical Supply, Inc. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 60429-066_f09ab4cf-ec4c-4ae4-b0bb-38847c766899 60429-066 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20081215 ANDA ANDA090255 Golden State Medical Supply, Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 60429-067_f09ab4cf-ec4c-4ae4-b0bb-38847c766899 60429-067 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20081215 ANDA ANDA090255 Golden State Medical Supply, Inc. HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 60429-068_39c135ec-0191-483c-bc9c-42000d3452d9 60429-068 HUMAN PRESCRIPTION DRUG Doxycyclate Hyclate Doxycycline Hyclate CAPSULE ORAL 20021209 20160222 ANDA ANDA062396 Golden State Medical Supply, Inc. DOXYCYCLINE HYCLATE 100 mg/1 60429-069_59cfe828-4295-4a34-9d70-7f8768aec701 60429-069 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20030702 20160222 ANDA ANDA065095 Golden State Medical Supply, Inc. DOXYCYCLINE HYCLATE 100 mg/1 60429-071_0e2f77de-769a-40fe-a148-e8641a78e396 60429-071 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20110512 ANDA ANDA075657 Golden State Medical Supply, Inc. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60429-072_0e2f77de-769a-40fe-a148-e8641a78e396 60429-072 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20110512 ANDA ANDA075657 Golden State Medical Supply, Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60429-073_0e2f77de-769a-40fe-a148-e8641a78e396 60429-073 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20110512 ANDA ANDA075657 Golden State Medical Supply, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60429-074_0e2f77de-769a-40fe-a148-e8641a78e396 60429-074 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20110512 ANDA ANDA075657 Golden State Medical Supply, Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60429-076_cb4f4415-a614-476a-b897-a14842e69bd8 60429-076 HUMAN PRESCRIPTION DRUG Chloroquine Chloroquine Phosphate TABLET ORAL 19750709 ANDA ANDA083082 Golden State Medical Supply, Inc. CHLOROQUINE PHOSPHATE 250 mg/1 Antimalarial [EPC] 60429-077_cb4f4415-a614-476a-b897-a14842e69bd8 60429-077 HUMAN PRESCRIPTION DRUG Chloroquine Chloroquine Phosphate TABLET, COATED ORAL 19990917 ANDA ANDA083082 Golden State Medical Supply, Inc. CHLOROQUINE PHOSPHATE 500 mg/1 Antimalarial [EPC] 60429-078_8ea3c966-fe36-4e4d-ac92-f2405437a513 60429-078 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20140423 ANDA ANDA202539 Golden State Medical Supply, Inc. PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 60429-079_8ea3c966-fe36-4e4d-ac92-f2405437a513 60429-079 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20140423 ANDA ANDA202539 Golden State Medical Supply, Inc. PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 60429-080_8ea3c966-fe36-4e4d-ac92-f2405437a513 60429-080 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20140327 ANDA ANDA202539 Golden State Medical Supply, Inc. PARICALCITOL 4 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 60429-081_ae8a6c8f-c1f7-47bb-b1ed-497ab7ed0e57 60429-081 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19930927 ANDA ANDA074270 Golden State Medical Supply, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 60429-082_9ff0a057-de02-44c0-bd63-c78ab59f4430 60429-082 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20120920 ANDA ANDA075795 Golden State Medical Supply Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 60429-083_9ff0a057-de02-44c0-bd63-c78ab59f4430 60429-083 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20120920 ANDA ANDA075795 Golden State Medical Supply Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 60429-084_0369e77d-94da-488f-bc9b-e9a68bc13da3 60429-084 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid TABLET ORAL 20140820 ANDA ANDA202286 Golden State Medical Supply, Inc. TRANEXAMIC ACID 650 1/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 60429-091_9aa8023c-4905-4d63-86b5-259d20cba579 60429-091 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090210 ANDA ANDA078774 Golden State Medical Supply, Inc. LEVETIRACETAM 100 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-092_637c272d-2adc-4f9e-aed2-2a0845a25a14 60429-092 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Golden State Medical Supply, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-093_637c272d-2adc-4f9e-aed2-2a0845a25a14 60429-093 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Golden State Medical Supply, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-094_637c272d-2adc-4f9e-aed2-2a0845a25a14 60429-094 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Golden State Medical Supply, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-095_627e6f8b-6056-42de-a279-98cc045bec96 60429-095 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19990827 ANDA ANDA088292 Golden State Medical Supply, Inc. IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 60429-096_627e6f8b-6056-42de-a279-98cc045bec96 60429-096 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19990827 ANDA ANDA088262 Golden State Medical Supply, Inc. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 60429-097_627e6f8b-6056-42de-a279-98cc045bec96 60429-097 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19990827 ANDA ANDA088276 Golden State Medical Supply, Inc. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 60429-098_8e5e2b3a-467b-4312-9778-8ff2ce938838 60429-098 HUMAN PRESCRIPTION DRUG Trospium Chloride Trospium Chloride CAPSULE, EXTENDED RELEASE ORAL 20140718 ANDA ANDA091289 Golden State Medical Supply, Inc. TROSPIUM CHLORIDE 60 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 60429-099_8ab3f0f4-2e43-41c9-bfbc-fec3ebc0a655 60429-099 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 Golden State Medical Supply, Inc. DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 60429-100_8ab3f0f4-2e43-41c9-bfbc-fec3ebc0a655 60429-100 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 Golden State Medical Supply, Inc. DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 60429-101_8020edd0-b9e6-428c-a534-fb8f780fbdf1 60429-101 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 19871026 ANDA ANDA086066 Golden State Medical Supply, Inc. ISOSORBIDE DINITRATE 10 mg/1 60429-102_8020edd0-b9e6-428c-a534-fb8f780fbdf1 60429-102 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 19871102 ANDA ANDA088088 Golden State Medical Supply, Inc. ISOSORBIDE DINITRATE 20 mg/1 60429-103_0ac65eae-b3dd-4cda-aec2-ff1e954a93a4 60429-103 HUMAN PRESCRIPTION DRUG TROSPIUM CHLORIDE TROSPIUM CHLORIDE TABLET ORAL 20130208 ANDA ANDA091513 Golden State Medical Supply, Inc. TROSPIUM CHLORIDE 20 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 60429-104_8020edd0-b9e6-428c-a534-fb8f780fbdf1 60429-104 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 19871026 ANDA ANDA086067 Golden State Medical Supply, Inc. ISOSORBIDE DINITRATE 5 mg/1 60429-105_a6e62b96-554b-4bb9-a172-2640f7f98905 60429-105 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20130208 ANDA ANDA077706 Golden State Medical Supply, Inc. POLYETHYLENE GLYCOL 3350 17 g/17g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 60429-106_1a8003d3-b990-4462-a787-ab93ca72f7b7 60429-106 HUMAN PRESCRIPTION DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride CAPSULE ORAL 20130315 ANDA ANDA078801 Golden State Medical Supply, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60429-107_8020edd0-b9e6-428c-a534-fb8f780fbdf1 60429-107 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 20070110 ANDA ANDA040591 Golden State Medical Supply, Inc. ISOSORBIDE DINITRATE 30 mg/1 60429-108_8020edd0-b9e6-428c-a534-fb8f780fbdf1 60429-108 HUMAN PRESCRIPTION DRUG Isosorbide Sublingual Isosorbide Dinitrate TABLET SUBLINGUAL 19781201 ANDA ANDA086054 Golden State Medical Supply, Inc. ISOSORBIDE DINITRATE 2.5 mg/1 60429-109_8020edd0-b9e6-428c-a534-fb8f780fbdf1 60429-109 HUMAN PRESCRIPTION DRUG Isosorbide Sublingual Isosorbide Dinitrate TABLET SUBLINGUAL 19871102 ANDA ANDA086055 Golden State Medical Supply, Inc. ISOSORBIDE DINITRATE 5 mg/1 60429-111_aa7a5142-2bf7-4174-aca9-1f6905879255 60429-111 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130911 ANDA ANDA203769 Golden State Medical Supply, Inc METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 60429-112_aa7a5142-2bf7-4174-aca9-1f6905879255 60429-112 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130911 ANDA ANDA203769 Golden State Medical Supply, Inc METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 60429-113_aa7a5142-2bf7-4174-aca9-1f6905879255 60429-113 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130911 ANDA ANDA203769 Golden State Medical Supply, Inc METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 60429-116_bcc8c397-a0b7-4211-8f89-fe7439a28d51 60429-116 HUMAN PRESCRIPTION DRUG Chlorothiazide Chlorothiazide TABLET ORAL 20050830 ANDA ANDA086028 Golden State Medical Supply, Inc. CHLOROTHIAZIDE 250 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60429-117_bcc8c397-a0b7-4211-8f89-fe7439a28d51 60429-117 HUMAN PRESCRIPTION DRUG Chlorothiazide Chlorothiazide TABLET ORAL 20050830 ANDA ANDA087736 Golden State Medical Supply, Inc. CHLOROTHIAZIDE 500 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60429-118_0ad25b14-51ab-45f4-a488-69b2e93de5b1 60429-118 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET, FILM COATED ORAL 20140220 ANDA ANDA200958 Golden State Medical Supply, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 60429-119_0ad25b14-51ab-45f4-a488-69b2e93de5b1 60429-119 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET, FILM COATED ORAL 20140220 ANDA ANDA200958 Golden State Medical Supply, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 60429-120_536811ab-308b-4866-9185-9e4149483512 60429-120 HUMAN PRESCRIPTION DRUG Carbamazepine carbamazepine SUSPENSION ORAL 20040920 ANDA ANDA076729 Golden State Medical Supply, Inc. CARBAMAZEPINE 100 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 60429-121_c8d227ff-296e-4485-b4d5-3cb3c1903062 60429-121 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130612 ANDA ANDA090174 Golden State Medical Supply, Inc VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60429-122_c8d227ff-296e-4485-b4d5-3cb3c1903062 60429-122 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130612 ANDA ANDA090174 Golden State Medical Supply, Inc VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60429-123_c8d227ff-296e-4485-b4d5-3cb3c1903062 60429-123 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130612 ANDA ANDA090174 Golden State Medical Supply, Inc VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60429-124_86ae4a58-beb1-4b4c-86ea-e65238766c1f 60429-124 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 20140422 ANDA ANDA074673 Golden State Medical Supply, Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 60429-125_86ae4a58-beb1-4b4c-86ea-e65238766c1f 60429-125 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 20140422 ANDA ANDA074673 Golden State Medical Supply, Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 60429-126_eeae39f6-9cea-4044-944c-8afe6713c0f2 60429-126 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140715 ANDA ANDA078494 Golden State Medical Supply, Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60429-127_eeae39f6-9cea-4044-944c-8afe6713c0f2 60429-127 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140715 ANDA ANDA078494 Golden State Medical Supply, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60429-128_eeae39f6-9cea-4044-944c-8afe6713c0f2 60429-128 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140715 ANDA ANDA078494 Golden State Medical Supply, Inc. PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60429-129_eeae39f6-9cea-4044-944c-8afe6713c0f2 60429-129 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140715 ANDA ANDA078494 Golden State Medical Supply, Inc. PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60429-130_0dd606ff-3628-4d3d-9f41-ec323fd9ed54 60429-130 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA080292 Golden State Medical Supply, Inc. PREDNISONE 5 mg/1 60429-131_0dd606ff-3628-4d3d-9f41-ec323fd9ed54 60429-131 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA088832 Golden State Medical Supply, Inc. PREDNISONE 10 mg/1 60429-132_0dd606ff-3628-4d3d-9f41-ec323fd9ed54 60429-132 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 Golden State Medical Supply, Inc. PREDNISONE 20 mg/1 60429-135_15333076-e7eb-4daa-bef3-c36f4953d910 60429-135 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Golden State Medical Supply, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-138_955df8fb-3341-4a1e-bbdd-152d5c06f1d6 60429-138 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20100716 ANDA ANDA075517 Golden State Medical Supply, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 60429-139_d74c1d6c-f144-44a7-99b8-7cfe87e5473a 60429-139 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20130322 ANDA ANDA077118 Golden State Medical Supply, Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60429-140_d74c1d6c-f144-44a7-99b8-7cfe87e5473a 60429-140 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20130322 ANDA ANDA076862 Golden State Medical Supply, Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60429-141_5e4bf7e0-dbc6-4b7e-bbac-fb536ed71989 60429-141 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20100415 ANDA ANDA077298 Golden State Medical Supply, Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60429-142_5e4bf7e0-dbc6-4b7e-bbac-fb536ed71989 60429-142 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20100415 ANDA ANDA077298 Golden State Medical Supply, Inc. METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60429-143_f3357a72-a68f-4ee5-be56-03f1dd8bef83 60429-143 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110425 ANDA ANDA078552 Golden State Medical Supply, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 60429-144_f3357a72-a68f-4ee5-be56-03f1dd8bef83 60429-144 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110425 ANDA ANDA078552 Golden State Medical Supply, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 60429-145_f3357a72-a68f-4ee5-be56-03f1dd8bef83 60429-145 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110425 ANDA ANDA078552 Golden State Medical Supply, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 60429-146_d1035cf9-d687-48df-ac03-aa00ef06618c 60429-146 HUMAN PRESCRIPTION DRUG Nimodipine Nimodipine CAPSULE, LIQUID FILLED ORAL 20080321 ANDA ANDA076740 Golden State Medical Supply, Inc. NIMODIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 60429-147_0af23fae-6ebd-43b8-aaf4-a4455f05d877 60429-147 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 19960709 ANDA ANDA062936 Golden State Medical Supply, Inc. PENICILLIN V POTASSIUM 250 mg/1 60429-148_0af23fae-6ebd-43b8-aaf4-a4455f05d877 60429-148 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 19960709 ANDA ANDA062935 Golden State Medical Supply, Inc. PENICILLIN V POTASSIUM 500 mg/1 60429-149_06c6c1b5-9b46-4400-a2d8-19678f18668f 60429-149 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20060731 ANDA ANDA040712 Golden State Medical Supply, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 60429-150_06c6c1b5-9b46-4400-a2d8-19678f18668f 60429-150 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20060731 ANDA ANDA040712 Golden State Medical Supply, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 60429-151_06c6c1b5-9b46-4400-a2d8-19678f18668f 60429-151 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20060731 ANDA ANDA040713 Golden State Medical Supply, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 60429-152_f1d6c0c3-6bff-4ea2-bcf8-0d679b5ccc6d 60429-152 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20130315 ANDA ANDA074260 Golden State Medical Supply, Inc. CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 60429-153_f1d6c0c3-6bff-4ea2-bcf8-0d679b5ccc6d 60429-153 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20130315 ANDA ANDA074260 Golden State Medical Supply, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 60429-154_f1d6c0c3-6bff-4ea2-bcf8-0d679b5ccc6d 60429-154 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20130315 ANDA ANDA074260 Golden State Medical Supply, Inc. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 60429-155_21408a33-8c32-48bf-b2cf-73c830abfe9a 60429-155 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride CAPSULE ORAL 19961001 ANDA ANDA040161 Golden State Medical Supply, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 60429-156_21408a33-8c32-48bf-b2cf-73c830abfe9a 60429-156 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 Golden State Medical Supply, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 60429-162_e3ccebb4-a76e-4405-9ea2-cf66505b3336 60429-162 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20140212 ANDA ANDA062505 Golden State Medical Supply, Inc. DOXYCYCLINE HYCLATE 100 mg/1 60429-163_2d934d80-6d28-415d-8963-bf8d1e4b038c 60429-163 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE ORAL 20090811 ANDA ANDA072781 Golden State Medical Supply, Inc. NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 60429-164_f535fcd2-a50a-4423-85d9-705fd2d9a470 60429-164 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Golden State Medical Supply, Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60429-165_f535fcd2-a50a-4423-85d9-705fd2d9a470 60429-165 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Golden State Medical Supply, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60429-166_f535fcd2-a50a-4423-85d9-705fd2d9a470 60429-166 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Golden State Medical Supply, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60429-167_89866dbd-30ec-4095-a46a-6ac079be3943 60429-167 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20140828 ANDA ANDA200295 Golden State Medical Supply, Inc. LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 60429-168_89866dbd-30ec-4095-a46a-6ac079be3943 60429-168 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20140828 ANDA ANDA200295 Golden State Medical Supply, Inc. LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 60429-169_89866dbd-30ec-4095-a46a-6ac079be3943 60429-169 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20140828 ANDA ANDA200295 Golden State Medical Supply, Inc. LIOTHYRONINE SODIUM 50 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 60429-170_8fa9225f-dd1a-4225-a2b3-34535451b473 60429-170 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Golden State Medical Supply, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 60429-171_19dde540-3d29-4db4-9570-6ca15f09e0fe 60429-171 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20100125 ANDA ANDA072710 Golden State Medical Supply, Inc. SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-172_19dde540-3d29-4db4-9570-6ca15f09e0fe 60429-172 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20100125 ANDA ANDA072711 Golden State Medical Supply, Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-173_f3a26d92-b662-4896-82eb-261948042408 60429-173 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110520 ANDA ANDA077045 Golden State Medical Supply, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60429-174_f3a26d92-b662-4896-82eb-261948042408 60429-174 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110520 ANDA ANDA077045 Golden State Medical Supply, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60429-175_f3a26d92-b662-4896-82eb-261948042408 60429-175 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110520 ANDA ANDA077045 Golden State Medical Supply, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60429-176_418bcf35-85a7-4ec6-bcd9-6adb5b4890cd 60429-176 HUMAN PRESCRIPTION DRUG Selegiline Hydrochloride Selegiline Hydrochloride TABLET ORAL 20130402 ANDA ANDA074871 Golden State Medical Supply, Inc. SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] 60429-177_7c9a8877-7364-4a3c-9345-78279fa282eb 60429-177 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20140508 ANDA ANDA078917 Golden State Medical Supply, Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 60429-183_0a12343f-5733-40cc-93b4-a02f5147fb91 60429-183 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20131104 ANDA ANDA075657 Golden State Medical Supply, Inc. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60429-184_0a12343f-5733-40cc-93b4-a02f5147fb91 60429-184 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20131104 ANDA ANDA075657 Golden State Medical Supply, Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60429-185_0a12343f-5733-40cc-93b4-a02f5147fb91 60429-185 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20131104 ANDA ANDA075657 Golden State Medical Supply, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60429-186_0a12343f-5733-40cc-93b4-a02f5147fb91 60429-186 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20131104 ANDA ANDA075657 Golden State Medical Supply, Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60429-187_2d082996-ff62-4e65-a4b1-191520238c6a 60429-187 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071258 Golden State Medical Supply, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 60429-188_2d082996-ff62-4e65-a4b1-191520238c6a 60429-188 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071196 Golden State Medical Supply, Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 60429-189_5c9ed271-5edf-4191-8b85-c64ab091488b 60429-189 HUMAN PRESCRIPTION DRUG CHLORDIAZEPOXIDE HYDROCHLORIDE and CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE and CLIDINIUM BROMIDE CAPSULE ORAL 20100122 20170315 UNAPPROVED DRUG OTHER Golden State Medical Supply, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] CIV 60429-195_6627aaac-48b7-4f3b-bd57-5a16c39f14c3 60429-195 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20110602 ANDA ANDA077538 Golden State Medical Supply, Inc. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60429-196_d3832a1a-a140-49c1-a7df-134fa81341e3 60429-196 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20130911 ANDA ANDA091681 Golden State Medical Supply, Inc. DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] 60429-201_a3f250f0-d993-48cd-b68d-e8b5de89b796 60429-201 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20140721 ANDA ANDA076113 Golden State Medical Supply, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60429-202_a3f250f0-d993-48cd-b68d-e8b5de89b796 60429-202 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20140721 ANDA ANDA076113 Golden State Medical Supply, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60429-203_a3f250f0-d993-48cd-b68d-e8b5de89b796 60429-203 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20140721 ANDA ANDA076113 Golden State Medical Supply, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60429-204_0751a05b-569f-4602-ba5e-f9f0079a4472 60429-204 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19981005 ANDA ANDA087127 Golden State Medical Supply, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 60429-205_0751a05b-569f-4602-ba5e-f9f0079a4472 60429-205 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087128 Golden State Medical Supply, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 60429-210_cd45db80-3cf3-4714-989b-de11f249bdfb 60429-210 HUMAN PRESCRIPTION DRUG Tranylcypromine Sulfate tranylcypromine sulfate TABLET ORAL 20120210 ANDA ANDA040640 Golden State Medical Supply, Inc. TRANYLCYPROMINE SULFATE 10 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] 60429-214_f8984e80-059c-4b5f-8fb8-9a239dd75464 60429-214 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20140723 ANDA ANDA203018 Golden State Medical Supply, Inc HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60429-215_f8984e80-059c-4b5f-8fb8-9a239dd75464 60429-215 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20140723 ANDA ANDA203018 Golden State Medical Supply, Inc HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60429-219_cc2eeea1-14a8-43df-bd32-26658997fd79 60429-219 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20140422 ANDA ANDA075682 Golden State Medical Supply, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-220_cc2eeea1-14a8-43df-bd32-26658997fd79 60429-220 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20140422 ANDA ANDA075682 Golden State Medical Supply, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-221_cc2eeea1-14a8-43df-bd32-26658997fd79 60429-221 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20140422 ANDA ANDA075682 Golden State Medical Supply, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-222_b43e4644-024c-4aa6-b403-19152c785802 60429-222 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20101227 ANDA ANDA077714 Golden State Medical Supply, Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 60429-223_87b0f45c-b80f-4596-831e-48206d19884b 60429-223 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20080924 ANDA ANDA040808 Golden State Medical Supply, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 60429-224_87b0f45c-b80f-4596-831e-48206d19884b 60429-224 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20120822 ANDA ANDA040808 Golden State Medical Supply, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 60429-225_87b0f45c-b80f-4596-831e-48206d19884b 60429-225 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20080924 ANDA ANDA040808 Golden State Medical Supply, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 60429-226_abaf380b-7434-426a-934b-73f6f094c82e 60429-226 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20101116 ANDA ANDA077973 Golden State Medical Supply, Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 60429-230_2d082996-ff62-4e65-a4b1-191520238c6a 60429-230 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071196 Golden State Medical Supply, Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 60429-231_e40f0efb-67ce-451b-8834-06e268c588f9 60429-231 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20001114 ANDA ANDA040337 Golden State Medical Supply, Inc. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 60429-234_6378779f-e2df-44e3-a2c6-fcfe2c719a11 60429-234 HUMAN PRESCRIPTION DRUG FOSINOPRIL SODIUM FOSINOPRIL SODIUM TABLET ORAL 20111227 ANDA ANDA076906 Golden State Medical Supply FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60429-235_6378779f-e2df-44e3-a2c6-fcfe2c719a11 60429-235 HUMAN PRESCRIPTION DRUG FOSINOPRIL SODIUM FOSINOPRIL SODIUM TABLET ORAL 20111227 ANDA ANDA076906 Golden State Medical Supply FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60429-236_6378779f-e2df-44e3-a2c6-fcfe2c719a11 60429-236 HUMAN PRESCRIPTION DRUG FOSINOPRIL SODIUM FOSINOPRIL SODIUM TABLET ORAL 20111227 ANDA ANDA076906 Golden State Medical Supply FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60429-239_1554b8d1-637e-4059-8366-18a544610dd6 60429-239 HUMAN PRESCRIPTION DRUG NEOMYCIN SULFATE NEOMYCIN SULFATE TABLET ORAL 20110103 ANDA ANDA065468 Golden State Medical Supply, Inc. NEOMYCIN SULFATE 500 mg/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 60429-241_953db236-b848-484f-83b7-436c3a274c88 60429-241 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 Golden State Medical Supply, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 60429-242_953db236-b848-484f-83b7-436c3a274c88 60429-242 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 Golden State Medical Supply, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 60429-243_4934f1b8-ca20-4ed9-9682-9203974ceced 60429-243 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980405 ANDA ANDA075078 Golden State Medical Supply, Inc. ETODOLAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-244_4934f1b8-ca20-4ed9-9682-9203974ceced 60429-244 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980405 ANDA ANDA075078 Golden State Medical Supply, Inc. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-245_d5b2efc5-ce8c-4ae7-bbcc-1db4da777f2a 60429-245 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20090817 ANDA ANDA040833 Golden State Medical Supply, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 60429-247_7551b0a2-bfbd-4a9e-9348-654724c13a29 60429-247 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride amiodarone hydrochloride TABLET ORAL 20010330 ANDA ANDA075424 Golden State Medical Supply, Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 60429-248_b0ef9f29-1057-49bf-a097-b9dde090293d 60429-248 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Golden State Medical Supply, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60429-249_b0ef9f29-1057-49bf-a097-b9dde090293d 60429-249 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Golden State Medical Supply, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60429-250_b0ef9f29-1057-49bf-a097-b9dde090293d 60429-250 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Golden State Medical Supply, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60429-251_46e661aa-b1bd-465e-a800-03bd3455d7d1 60429-251 HUMAN PRESCRIPTION DRUG Methscopolamine Methscopolamine Bromide TABLET ORAL 20061228 ANDA ANDA040624 Golden State Medical Supply, Inc. METHSCOPOLAMINE BROMIDE 5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 60429-252_0ea5d62d-a469-470b-98dc-9fb97dd15478 60429-252 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 19950612 ANDA ANDA089718 Golden State Medical Supply, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 60429-253_0ea5d62d-a469-470b-98dc-9fb97dd15478 60429-253 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 19980818 ANDA ANDA040336 Golden State Medical Supply, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 60429-254_9de2e32b-2835-42a2-830d-297852e3e72a 60429-254 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20110520 ANDA ANDA076697 Golden State Medical Supply, Inc. CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 60429-255_9de2e32b-2835-42a2-830d-297852e3e72a 60429-255 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20110520 ANDA ANDA076697 Golden State Medical Supply, Inc. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 60429-256_9de2e32b-2835-42a2-830d-297852e3e72a 60429-256 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20110520 ANDA ANDA076697 Golden State Medical Supply, Inc. CARBAMAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 60429-257_064441bf-9088-4a07-b4ff-ac0e00147690 60429-257 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Golden State Medical Supply, Inc. CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60429-260_39c135ec-0191-483c-bc9c-42000d3452d9 60429-260 HUMAN PRESCRIPTION DRUG Doxycyclate Hyclate Doxycycline Hyclate CAPSULE ORAL 20021209 20160222 ANDA ANDA062396 Golden State Medical Supply, Inc. DOXYCYCLINE HYCLATE 50 mg/1 60429-262_006f20d3-e724-4c55-be41-a5b23d6b638d 60429-262 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 19730618 ANDA ANDA083365 Golden State Medical Supply, Inc. HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60429-265_0a5c7030-5fac-4708-b309-f9d07103285a 60429-265 HUMAN PRESCRIPTION DRUG Hydroxyurea Hydroxyurea CAPSULE ORAL 19990224 ANDA ANDA075340 Golden State Medical Supply, Inc. HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] 60429-267_d8dc4835-11d0-439b-b0d0-26676602e7c9 60429-267 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20030617 20150330 ANDA ANDA076490 Golden State Medical Supply, Inc. LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] 60429-270_a6830f75-95ef-43c8-bff7-546f6a353410 60429-270 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20130322 ANDA ANDA075876 Golden State Medical Supply OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 60429-271_a6830f75-95ef-43c8-bff7-546f6a353410 60429-271 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20130322 ANDA ANDA075876 Golden State Medical Supply OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 60429-272_82bb75cc-0d36-44ab-9ea6-2bd26998ce0f 60429-272 HUMAN PRESCRIPTION DRUG Flutamide Flutamide CAPSULE ORAL 20010918 ANDA ANDA075298 Golden State Medical Supply, Inc. FLUTAMIDE 125 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 60429-273_15653c41-077f-4ec8-88eb-9262ea5150aa 60429-273 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20060701 20150830 ANDA ANDA040667 Golden State Medical Supply, Inc. PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-276_e40f0efb-67ce-451b-8834-06e268c588f9 60429-276 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20001114 ANDA ANDA040337 Golden State Medical Supply, Inc. TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 60429-277_66be31a1-0a7a-4dc5-badd-0b34b7ecab35 60429-277 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20130416 ANDA ANDA075133 Golden State Medical Supply, Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60429-278_66be31a1-0a7a-4dc5-badd-0b34b7ecab35 60429-278 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20130416 ANDA ANDA075133 Golden State Medical Supply, Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60429-279_66be31a1-0a7a-4dc5-badd-0b34b7ecab35 60429-279 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20130416 ANDA ANDA075133 Golden State Medical Supply, Inc. LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60429-280_5763cc1a-7def-4b1b-9831-a23f0ee63d9f 60429-280 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride ER Metformin Hydrochloride ER TABLET, FILM COATED ORAL 20060412 ANDA ANDA076869 Golden State Medical Supply, Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 60429-281_bfdf0e74-5f8e-4ae8-b766-5037b04370bd 60429-281 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20140423 ANDA ANDA200900 Golden State Medical Supply, Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 60429-282_bfdf0e74-5f8e-4ae8-b766-5037b04370bd 60429-282 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20140423 ANDA ANDA200900 Golden State Medical Supply, Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 60429-286_86bc1658-398a-4e87-8c6f-a4202255de82 60429-286 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, FILM COATED ORAL 20120531 ANDA ANDA200654 Golden State Medical Supply, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 60429-287_152d32ce-5e67-42cb-9003-b89e86f8487d 60429-287 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Golden State Medical Supply, Inc. CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 60429-288_152d32ce-5e67-42cb-9003-b89e86f8487d 60429-288 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Golden State Medical Supply, Inc. CLOMIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 60429-289_5af7ec26-5666-41a9-a0a9-1c3b09f6638e 60429-289 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Golden State Medical Supply, Inc. CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 60429-290_22a99f74-2718-48b3-b686-caf102d3071c 60429-290 HUMAN PRESCRIPTION DRUG Flavoxate Hydrochloride Flavoxate Hydrochloride TABLET ORAL 20110221 ANDA ANDA076835 Golden State Medical Supply, Inc. FLAVOXATE HYDROCHLORIDE 100 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 60429-294_8d4040f1-9ddb-448d-8aaa-b3961d7d2f1b 60429-294 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20140520 ANDA ANDA201507 Golden State Medical Supply, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 60429-295_8d4040f1-9ddb-448d-8aaa-b3961d7d2f1b 60429-295 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20140520 ANDA ANDA201507 Golden State Medical Supply, Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 60429-297_c0320d58-a947-451e-96fb-7c9d5ef92bf4 60429-297 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20090701 ANDA ANDA074415 Golden State Medical Supply, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 60429-298_b00d2319-fe43-47cf-9169-86e2d984e1eb 60429-298 HUMAN PRESCRIPTION DRUG Nevirapine nevirapine TABLET ORAL 20120522 ANDA ANDA203176 Golden State Medical Supply, Inc. NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 60429-299_6c59bda9-a496-4da0-8655-1dff729d3991 60429-299 HUMAN PRESCRIPTION DRUG Piroxicam piroxicam CAPSULE ORAL 20100105 ANDA ANDA074116 Golden State Medical Supply, Inc. PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-300_6c59bda9-a496-4da0-8655-1dff729d3991 60429-300 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20100105 ANDA ANDA074118 Golden State Medical Supply, Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-301_c7fa330d-d8f1-487e-a730-bafae123e9a8 60429-301 HUMAN PRESCRIPTION DRUG clopidogrel bisulfate clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA076274 Golden State Medical Supply, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 60429-304_b4219281-d79f-45ac-86dd-82c399415032 60429-304 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111212 ANDA ANDA091459 Golden State Medical Supply, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 60429-305_b4219281-d79f-45ac-86dd-82c399415032 60429-305 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111212 ANDA ANDA091459 Golden State Medical Supply, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 60429-306_b4219281-d79f-45ac-86dd-82c399415032 60429-306 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111212 ANDA ANDA091459 Golden State Medical Supply, Inc. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 60429-307_9720518e-9f70-4811-84ca-69a526d8a904 60429-307 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081125 ANDA ANDA077284 Golden State Medical Supply, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 60429-308_9720518e-9f70-4811-84ca-69a526d8a904 60429-308 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070612 ANDA ANDA077284 Golden State Medical Supply, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 60429-309_b28df0b4-d9eb-4932-a836-86f2eb22a1d7 60429-309 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 20120921 ANDA ANDA077309 Golden State Medical Supply, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 60429-310_b28df0b4-d9eb-4932-a836-86f2eb22a1d7 60429-310 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 20120921 ANDA ANDA077309 Golden State Medical Supply, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 60429-311_4934f1b8-ca20-4ed9-9682-9203974ceced 60429-311 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980311 ANDA ANDA075074 Golden State Medical Supply, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-312_4934f1b8-ca20-4ed9-9682-9203974ceced 60429-312 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980312 ANDA ANDA075074 Golden State Medical Supply, Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-313_4934f1b8-ca20-4ed9-9682-9203974ceced 60429-313 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 Golden State Medical Supply, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-314_4934f1b8-ca20-4ed9-9682-9203974ceced 60429-314 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 Golden State Medical Supply, Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-315_4934f1b8-ca20-4ed9-9682-9203974ceced 60429-315 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 Golden State Medical Supply, Inc. ETODOLAC 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60429-316_2ebd1e08-2500-463a-902c-7fd18ecc2d82 60429-316 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20110222 ANDA ANDA091129 Golden State Medical Supply, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60429-317_2ebd1e08-2500-463a-902c-7fd18ecc2d82 60429-317 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20110222 ANDA ANDA091129 Golden State Medical Supply, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60429-318_2ebd1e08-2500-463a-902c-7fd18ecc2d82 60429-318 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20110222 ANDA ANDA091129 Golden State Medical Supply, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60429-319_504d0066-a070-41b0-95b7-09994e4ff03e 60429-319 HUMAN PRESCRIPTION DRUG LEFLUNOMIDE LEFLUNOMIDE TABLET ORAL 20050913 ANDA ANDA077090 Golden State Medical Supply, Inc. LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] 60429-320_504d0066-a070-41b0-95b7-09994e4ff03e 60429-320 HUMAN PRESCRIPTION DRUG LEFLUNOMIDE LEFLUNOMIDE TABLET ORAL 20050913 ANDA ANDA077090 Golden State Medical Supply, Inc. LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] 60429-323_42571de8-acc9-42ef-89b7-08b9a91e3fbd 60429-323 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Golden State Medical Supply, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60429-324_42571de8-acc9-42ef-89b7-08b9a91e3fbd 60429-324 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Golden State Medical Supply, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60429-325_42571de8-acc9-42ef-89b7-08b9a91e3fbd 60429-325 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Golden State Medical Supply, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60429-326_42571de8-acc9-42ef-89b7-08b9a91e3fbd 60429-326 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Golden State Medical Supply, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60429-330_db790f58-3c27-49c3-b7f6-58344a14400e 60429-330 HUMAN PRESCRIPTION DRUG pioglitazone hydrochloride pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA078472 Golden State Medical Supply PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 60429-331_db790f58-3c27-49c3-b7f6-58344a14400e 60429-331 HUMAN PRESCRIPTION DRUG pioglitazone hydrochloride pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA078472 Golden State Medical Supply PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 60429-332_db790f58-3c27-49c3-b7f6-58344a14400e 60429-332 HUMAN PRESCRIPTION DRUG pioglitazone hydrochloride pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA078472 Golden State Medical Supply PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 60429-340_11081d31-cc92-48fe-ac65-bd465ba1218d 60429-340 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20100824 ANDA ANDA091256 Golden State Medical Supply, Inc. BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 60429-341_11081d31-cc92-48fe-ac65-bd465ba1218d 60429-341 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20100406 ANDA ANDA091256 Golden State Medical Supply, Inc. BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 60429-342_11081d31-cc92-48fe-ac65-bd465ba1218d 60429-342 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20100406 ANDA ANDA091256 Golden State Medical Supply, Inc. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 60429-343_11081d31-cc92-48fe-ac65-bd465ba1218d 60429-343 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20100406 ANDA ANDA091256 Golden State Medical Supply, Inc. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 60429-347_459c03fe-6682-47af-800d-e7790cbb94cc 60429-347 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110718 ANDA ANDA079013 Golden State Medical Supply, Inc. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60429-348_afd48e96-a64e-4e5a-ba21-504a53855397 60429-348 HUMAN PRESCRIPTION DRUG Phenelzine Sulfate Phenelzine Sulfate TABLET ORAL 20101214 ANDA ANDA200181 Golden State Medical Supply, Inc. PHENELZINE SULFATE 15 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] 60429-349_49d44b00-a624-47ce-802b-bdc40439a3c4 60429-349 HUMAN PRESCRIPTION DRUG Levetiracetam Extended-Release levetiracetam TABLET, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091261 Golden State Medical Supply, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-350_49d44b00-a624-47ce-802b-bdc40439a3c4 60429-350 HUMAN PRESCRIPTION DRUG Levetiracetam Extended-Release levetiracetam TABLET, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091261 Golden State Medical Supply, Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-353_f3637209-303e-4232-ae79-07315a990973 60429-353 HUMAN PRESCRIPTION DRUG LAMIVUDINE lamivudine TABLET, FILM COATED ORAL 20111202 ANDA ANDA091606 Golden State Medical Supply, Inc. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 60429-354_f3637209-303e-4232-ae79-07315a990973 60429-354 HUMAN PRESCRIPTION DRUG LAMIVUDINE lamivudine TABLET, FILM COATED ORAL 20111202 ANDA ANDA091606 Golden State Medical Supply, Inc. LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 60429-355_291701d5-1c9e-4629-a98f-26e035579a28 60429-355 HUMAN PRESCRIPTION DRUG CHOLESTYRAMINE cholestyramine POWDER, FOR SUSPENSION ORAL 20050915 ANDA ANDA077203 Golden State Medical Supply, Inc. CHOLESTYRAMINE 4 g/9g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 60429-356_291701d5-1c9e-4629-a98f-26e035579a28 60429-356 HUMAN PRESCRIPTION DRUG CHOLESTYRAMINE LIGHT cholestyramine light POWDER, FOR SUSPENSION ORAL 20050915 ANDA ANDA077204 Golden State Medical Supply, Inc. CHOLESTYRAMINE 4 g/5g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 60429-359_5c133dfe-3cb5-426b-ac30-daf814e12c47 60429-359 HUMAN PRESCRIPTION DRUG FAMCICLOVIR FAMCICLOVIR TABLET, FILM COATED ORAL 20111220 ANDA ANDA091480 Golden State Medical Supply, Inc. FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 60429-360_5c133dfe-3cb5-426b-ac30-daf814e12c47 60429-360 HUMAN PRESCRIPTION DRUG FAMCICLOVIR FAMCICLOVIR TABLET, FILM COATED ORAL 20111220 ANDA ANDA091480 Golden State Medical Supply, Inc. FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 60429-361_5c133dfe-3cb5-426b-ac30-daf814e12c47 60429-361 HUMAN PRESCRIPTION DRUG FAMCICLOVIR FAMCICLOVIR TABLET, FILM COATED ORAL 20111220 ANDA ANDA091480 Golden State Medical Supply, Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 60429-362_d801230d-0344-4cea-bb04-5818e931bb66 60429-362 HUMAN PRESCRIPTION DRUG Cilostazol cilostazol TABLET ORAL 20111018 ANDA ANDA077030 Golden State Medical Supply, Inc. CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 60429-363_d801230d-0344-4cea-bb04-5818e931bb66 60429-363 HUMAN PRESCRIPTION DRUG Cilostazol cilostazol TABLET ORAL 20111018 ANDA ANDA077030 Golden State Medical Supply, Inc. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 60429-364_9dcbdfb5-0ee4-45b2-8351-001ed2e1a1f5 60429-364 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20080409 ANDA ANDA077747 Golden State Medical Supply, Inc. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-365_9dcbdfb5-0ee4-45b2-8351-001ed2e1a1f5 60429-365 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20080409 ANDA ANDA077747 Golden State Medical Supply, Inc. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-366_9dcbdfb5-0ee4-45b2-8351-001ed2e1a1f5 60429-366 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20080409 ANDA ANDA077747 Golden State Medical Supply, Inc. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-367_c2942918-300c-4c1b-85d6-cde62c7bf67a 60429-367 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20110718 ANDA ANDA076341 Golden State Medical Supply PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60429-368_c2942918-300c-4c1b-85d6-cde62c7bf67a 60429-368 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20110718 ANDA ANDA076341 Golden State Medical Supply PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60429-369_c2942918-300c-4c1b-85d6-cde62c7bf67a 60429-369 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20110718 ANDA ANDA076341 Golden State Medical Supply PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60429-370_c2942918-300c-4c1b-85d6-cde62c7bf67a 60429-370 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20110718 ANDA ANDA076341 Golden State Medical Supply PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60429-371_03325ca1-4f51-41a1-92f3-ff7f96e01cc8 60429-371 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Golden State Medical Supply, Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 60429-372_03325ca1-4f51-41a1-92f3-ff7f96e01cc8 60429-372 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Golden State Medical Supply, Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 60429-373_03325ca1-4f51-41a1-92f3-ff7f96e01cc8 60429-373 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Golden State Medical Supply, Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 60429-374_03325ca1-4f51-41a1-92f3-ff7f96e01cc8 60429-374 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Golden State Medical Supply, Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 60429-375_03325ca1-4f51-41a1-92f3-ff7f96e01cc8 60429-375 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Golden State Medical Supply, Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 60429-376_03325ca1-4f51-41a1-92f3-ff7f96e01cc8 60429-376 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Golden State Medical Supply, Inc. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 60429-380_871f8356-809f-4a46-af62-bcc7839a361b 60429-380 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20130108 ANDA ANDA040734 Golden State Medical Supply Inc. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 60429-381_871f8356-809f-4a46-af62-bcc7839a361b 60429-381 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20130108 ANDA ANDA040734 Golden State Medical Supply Inc. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 60429-382_cfeb2b37-c295-46d0-be1e-68334c0a7f90 60429-382 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20130308 ANDA ANDA075350 Golden State Medical Supply, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-383_cfeb2b37-c295-46d0-be1e-68334c0a7f90 60429-383 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20130308 ANDA ANDA075350 Golden State Medical Supply, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-384_cfeb2b37-c295-46d0-be1e-68334c0a7f90 60429-384 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20130308 ANDA ANDA075350 Golden State Medical Supply, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-388_5ba85881-dba1-4932-a8dc-c1afdb980e98 60429-388 HUMAN OTC DRUG Fexofenadine Hydrochloride fexofenadine TABLET, FILM COATED ORAL 20140320 ANDA ANDA077081 Golden State Medical Supply, Inc. FEXOFENADINE HYDROCHLORIDE 60 mg/1 60429-389_5ba85881-dba1-4932-a8dc-c1afdb980e98 60429-389 HUMAN OTC DRUG Fexofenadine Hydrochloride fexofenadine TABLET, FILM COATED ORAL 20140320 ANDA ANDA077081 Golden State Medical Supply, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 60429-390_56d4a4ad-fbfc-4098-9a7d-1348a250b212 60429-390 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride sotalol hydrochloride TABLET ORAL 20030909 ANDA ANDA076214 Golden State Medical Supply, Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 60429-391_56d4a4ad-fbfc-4098-9a7d-1348a250b212 60429-391 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride sotalol hydrochloride TABLET ORAL 20030909 ANDA ANDA076214 Golden State Medical Supply, Inc. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC] 60429-392_56d4a4ad-fbfc-4098-9a7d-1348a250b212 60429-392 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride sotalol hydrochloride TABLET ORAL 20030909 ANDA ANDA076214 Golden State Medical Supply, Inc. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC] 60429-400_b2be10db-0512-49c8-9917-eae1ebc75470 60429-400 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140624 ANDA ANDA075828 Golden State Medical Supply, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60429-401_b2be10db-0512-49c8-9917-eae1ebc75470 60429-401 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140624 ANDA ANDA075828 Golden State Medical Supply, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60429-402_b2be10db-0512-49c8-9917-eae1ebc75470 60429-402 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140624 ANDA ANDA075828 Golden State Medical Supply, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60429-502_fc4262ca-f03c-4136-ad2f-906beba582ed 60429-502 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19931019 ANDA ANDA074174 Golden State Medical Supply, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60429-503_fc4262ca-f03c-4136-ad2f-906beba582ed 60429-503 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19931019 ANDA ANDA074174 Golden State Medical Supply, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60429-504_fc4262ca-f03c-4136-ad2f-906beba582ed 60429-504 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19931019 ANDA ANDA074174 Golden State Medical Supply, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60429-505_fc4262ca-f03c-4136-ad2f-906beba582ed 60429-505 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19931019 ANDA ANDA074174 Golden State Medical Supply, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60429-506_abdeee37-d0d8-4f22-a977-f8ea37c51f03 60429-506 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20140110 ANDA ANDA071638 Golden State Medical Supply, Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60429-507_abdeee37-d0d8-4f22-a977-f8ea37c51f03 60429-507 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20140110 ANDA ANDA071620 Golden State Medical Supply, Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60429-508_3f7f2fda-42ed-427a-bc9c-c24a1f20419f 60429-508 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20140220 ANDA ANDA203374 Golden State Medical Supply, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 60429-524_99afce68-e23f-400d-b652-69e7793fb7b7 60429-524 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20131018 ANDA ANDA074869 Golden State Medical Supply, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60429-525_99afce68-e23f-400d-b652-69e7793fb7b7 60429-525 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20131018 ANDA ANDA074869 Golden State Medical Supply, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60429-526_99afce68-e23f-400d-b652-69e7793fb7b7 60429-526 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20131018 ANDA ANDA074869 Golden State Medical Supply, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60429-536_66bec92c-3582-4aeb-97fe-6b78f83d95d6 60429-536 HUMAN PRESCRIPTION DRUG Methylin Methylphenidate Hydrochloride TABLET ORAL 20100520 20150630 ANDA ANDA040300 Golden State Medical Supply METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 60429-537_66bec92c-3582-4aeb-97fe-6b78f83d95d6 60429-537 HUMAN PRESCRIPTION DRUG Methylin Methylphenidate Hydrochloride TABLET ORAL 20100520 20150630 ANDA ANDA040300 Golden State Medical Supply METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 60429-538_66bec92c-3582-4aeb-97fe-6b78f83d95d6 60429-538 HUMAN PRESCRIPTION DRUG Methylin Methylphenidate Hydrochloride TABLET ORAL 20100520 20150630 ANDA ANDA040300 Golden State Medical Supply METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 60429-539_66bec92c-3582-4aeb-97fe-6b78f83d95d6 60429-539 HUMAN PRESCRIPTION DRUG Methylin ER Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100520 20150630 ANDA ANDA075629 Golden State Medical Supply METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 60429-540_66bec92c-3582-4aeb-97fe-6b78f83d95d6 60429-540 HUMAN PRESCRIPTION DRUG Methylin ER Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100520 20150630 ANDA ANDA075629 Golden State Medical Supply METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 60429-542_d528d12f-ce31-401b-8406-7d649050198a 60429-542 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 19861208 ANDA ANDA077107 Golden State Medical Supply, Inc. FLURAZEPAM HYDROCHLORIDE 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60429-543_d528d12f-ce31-401b-8406-7d649050198a 60429-543 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 19861208 ANDA ANDA071108 Golden State Medical Supply, Inc. FLURAZEPAM HYDROCHLORIDE 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60429-554_3c3e7d01-ce33-4628-bc73-58cdd07bbf29 60429-554 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20100515 ANDA ANDA085461 Golden State Medical Supply, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60429-555_3c3e7d01-ce33-4628-bc73-58cdd07bbf29 60429-555 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20100515 ANDA ANDA085472 Golden State Medical Supply, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60429-556_3c3e7d01-ce33-4628-bc73-58cdd07bbf29 60429-556 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20100515 ANDA ANDA085475 Golden State Medical Supply, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60429-566_2fb7763f-6ce4-43b9-b3be-90a66315828b 60429-566 HUMAN PRESCRIPTION DRUG Estazolam Estazolam TABLET ORAL 19970819 ANDA ANDA074818 Golden State Medical Supply, Inc. ESTAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60429-567_2fb7763f-6ce4-43b9-b3be-90a66315828b 60429-567 HUMAN PRESCRIPTION DRUG Estazolam Estazolam TABLET ORAL 19970819 ANDA ANDA074818 Golden State Medical Supply, Inc. ESTAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60429-570_679372cf-0f50-4c94-9370-77ea7649aa50 60429-570 HUMAN PRESCRIPTION DRUG Pentazocine and Naloxone Pentazocine hydrochloride and naloxone hydrochloride TABLET ORAL 20000324 ANDA ANDA074736 Golden State Medical Supply, Inc. NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE .5; 50 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIV 60429-576_cc0b862e-1c28-4adb-b9b7-e83ef5152cb6 60429-576 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20100520 ANDA ANDA040300 Golden State Medical Supply, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 60429-577_cc0b862e-1c28-4adb-b9b7-e83ef5152cb6 60429-577 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20100520 ANDA ANDA040300 Golden State Medical Supply, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 60429-578_cc0b862e-1c28-4adb-b9b7-e83ef5152cb6 60429-578 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20100520 ANDA ANDA040300 Golden State Medical Supply, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 60429-579_cc0b862e-1c28-4adb-b9b7-e83ef5152cb6 60429-579 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride ER Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100520 ANDA ANDA075629 Golden State Medical Supply, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 60429-580_cc0b862e-1c28-4adb-b9b7-e83ef5152cb6 60429-580 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride ER Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100520 ANDA ANDA075629 Golden State Medical Supply, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 60429-581_120cd2f0-7021-4036-a4c3-2e06f0252d74 60429-581 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20140203 ANDA ANDA077667 Golden State Medical Supply, Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 60429-582_120cd2f0-7021-4036-a4c3-2e06f0252d74 60429-582 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20140203 ANDA ANDA077667 Golden State Medical Supply, Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 60429-616_266e54ce-b327-4dcf-8fc7-b61aa7cc8df6 60429-616 HUMAN PRESCRIPTION DRUG Multi-Vitamin With Fluoride Vitamin A, Vitamin D, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Fluoride Ion, Ascorbic Acid, .Alpha.-Tocopherol-Acetate-DL, Cyanocobalamin TABLET, CHEWABLE ORAL 20101217 UNAPPROVED DRUG OTHER Golden State Medical Supply, Inc. ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; CYANOCOBALAMIN; FLUORIDE ION; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D 15; 60; 4.5; .25; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 60429-617_266e54ce-b327-4dcf-8fc7-b61aa7cc8df6 60429-617 HUMAN PRESCRIPTION DRUG Multi-Vitamin With Fluoride Vitamin A, Vitamin D, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Fluoride Ion, Ascorbic Acid, .Alpha.-Tocopherol-Acetate-DL, Cyanocobalamin TABLET, CHEWABLE ORAL 20101229 UNAPPROVED DRUG OTHER Golden State Medical Supply, Inc. ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; CYANOCOBALAMIN; FLUORIDE ION; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D 15; 60; 4.5; .5; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 60429-618_266e54ce-b327-4dcf-8fc7-b61aa7cc8df6 60429-618 HUMAN PRESCRIPTION DRUG Multi-Vitamin With Fluoride Vitamin A, Vitamin D, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Fluoride Ion, Ascorbic Acid, .Alpha.-Tocopherol-Acetate-DL, Cyanocobalamin TABLET, CHEWABLE ORAL 20101217 UNAPPROVED DRUG OTHER Golden State Medical Supply, Inc. ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; CYANOCOBALAMIN; FLUORIDE ION; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D 15; 60; 4.5; 1; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 60429-619_16521754-b181-4e9c-ad90-310f1a3d83d6 60429-619 HUMAN PRESCRIPTION DRUG Antipyrine and Benzocaine Antipyrine and Benzocaine SOLUTION AURICULAR (OTIC) 20090430 UNAPPROVED DRUG OTHER Golden State Medical Supply, Inc. ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 60429-620_a1dfb4e7-4143-4422-b7a7-292e4fd75044 60429-620 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Golden State Medical Supply, Inc. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 60429-621_a1dfb4e7-4143-4422-b7a7-292e4fd75044 60429-621 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Golden State Medical Supply, Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 60429-622_a1dfb4e7-4143-4422-b7a7-292e4fd75044 60429-622 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Golden State Medical Supply, Inc. OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 60429-623_a1dfb4e7-4143-4422-b7a7-292e4fd75044 60429-623 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Golden State Medical Supply, Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 60429-624_a1dfb4e7-4143-4422-b7a7-292e4fd75044 60429-624 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Golden State Medical Supply, Inc. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 60429-625_a1dfb4e7-4143-4422-b7a7-292e4fd75044 60429-625 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Golden State Medical Supply, Inc. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 60429-700_91a290bc-b91f-461e-a6e4-3fc54c1a00fe 60429-700 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20070815 ANDA ANDA040760 Golden State Medical Supply, Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 60429-703_b218b02c-e6a1-410c-95fa-f798260c51ab 60429-703 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 20010618 ANDA ANDA075191 Golden State Medical Supply, Inc. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 60429-711_ac462791-697e-4b4a-baa1-8ca229d2fe94 60429-711 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 19970422 ANDA ANDA074833 Golden State Medical Supply, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 60429-712_9726da3b-d412-4c66-8dda-536fbacd52e7 60429-712 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19990305 ANDA ANDA075382 Golden State Medical Supply, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 60429-713_9726da3b-d412-4c66-8dda-536fbacd52e7 60429-713 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19990305 ANDA ANDA075382 Golden State Medical Supply, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 60429-715_f1843e43-2bb2-400a-b10b-c78397386338 60429-715 HUMAN PRESCRIPTION DRUG Methenamine Hippurate Methenamine Hippurate TABLET ORAL 20030701 ANDA ANDA076411 Golden State Medical Supply, Inc. METHENAMINE HIPPURATE 1 g/1 60429-720_a526ee23-eb4b-4bf4-a815-61ae171d182b 60429-720 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Golden State Medical Supply, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 60429-721_a526ee23-eb4b-4bf4-a815-61ae171d182b 60429-721 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Golden State Medical Supply, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 60429-725_e3d7e34f-442b-471d-af12-0647af973f86 60429-725 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060829 ANDA ANDA076172 Golden State Medical Supply, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 60429-734_74458363-9346-4f6d-ab4f-af97d5fcd634 60429-734 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Golden State Medical Supply, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60429-735_74458363-9346-4f6d-ab4f-af97d5fcd634 60429-735 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Golden State Medical Supply, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60429-736_74458363-9346-4f6d-ab4f-af97d5fcd634 60429-736 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Golden State Medical Supply, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60429-737_74458363-9346-4f6d-ab4f-af97d5fcd634 60429-737 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Golden State Medical Supply, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60429-738_e09e0cd6-cad5-4792-93c7-56dec5383e05 60429-738 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Golden State Medical Supply, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-739_e09e0cd6-cad5-4792-93c7-56dec5383e05 60429-739 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Golden State Medical Supply, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-740_e09e0cd6-cad5-4792-93c7-56dec5383e05 60429-740 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Golden State Medical Supply, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-742_75f64190-5b00-4465-8db2-0a855452ff06 60429-742 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 20150830 ANDA ANDA076794 Golden State Medical Supply, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 60429-743_75f64190-5b00-4465-8db2-0a855452ff06 60429-743 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 20150830 ANDA ANDA076794 Golden State Medical Supply, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 60429-748_6674d53a-7137-4822-8841-4982f702a1b8 60429-748 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Golden State Medical Supply, Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 60429-749_6674d53a-7137-4822-8841-4982f702a1b8 60429-749 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Golden State Medical Supply, Inc. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC] 60429-750_6674d53a-7137-4822-8841-4982f702a1b8 60429-750 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Golden State Medical Supply, Inc. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC] 60429-751_6674d53a-7137-4822-8841-4982f702a1b8 60429-751 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Golden State Medical Supply, Inc. SOTALOL HYDROCHLORIDE 240 mg/1 Antiarrhythmic [EPC] 60429-753_9a58c45d-4b14-44d7-86ed-2997ac6942dd 60429-753 HUMAN PRESCRIPTION DRUG Betaxolol Betaxolol TABLET, FILM COATED ORAL 20080627 ANDA ANDA078962 Golden State Medical Supply, Inc. BETAXOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60429-754_9a58c45d-4b14-44d7-86ed-2997ac6942dd 60429-754 HUMAN PRESCRIPTION DRUG Betaxolol Betaxolol TABLET, FILM COATED ORAL 20080627 ANDA ANDA078962 Golden State Medical Supply, Inc. BETAXOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60429-758_4b1e7c09-c393-4f1e-be68-8a662ceda185 60429-758 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET ORAL 20010507 ANDA ANDA075902 Golden State Medical Supply, Inc. FLUVOXAMINE MALEATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60429-759_4b1e7c09-c393-4f1e-be68-8a662ceda185 60429-759 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET ORAL 20010507 ANDA ANDA075902 Golden State Medical Supply, Inc. FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60429-760_4b1e7c09-c393-4f1e-be68-8a662ceda185 60429-760 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET ORAL 20010507 ANDA ANDA075902 Golden State Medical Supply, Inc. FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60429-762_b4509afc-539b-4d7f-97d4-5e9c98c2f65a 60429-762 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20060906 ANDA ANDA077150 Golden State Medical Supply, Inc. CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 60429-763_b4509afc-539b-4d7f-97d4-5e9c98c2f65a 60429-763 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20060906 ANDA ANDA077022 Golden State Medical Supply, Inc. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 60429-765_f5c1a389-a4ac-40fb-b553-0ac5f1335310 60429-765 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Golden State Medical Supply, Inc. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 60429-766_f5c1a389-a4ac-40fb-b553-0ac5f1335310 60429-766 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Golden State Medical Supply, Inc. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 60429-767_f5c1a389-a4ac-40fb-b553-0ac5f1335310 60429-767 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Golden State Medical Supply, Inc. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 60429-768_f5c1a389-a4ac-40fb-b553-0ac5f1335310 60429-768 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Golden State Medical Supply, Inc. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 60429-769_333c0fec-d9a2-4960-89ce-36af804ece46 60429-769 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET ORAL 20090327 ANDA ANDA079162 Golden State Medical Supply, Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-770_333c0fec-d9a2-4960-89ce-36af804ece46 60429-770 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET ORAL 20090327 ANDA ANDA079162 Golden State Medical Supply, Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-771_333c0fec-d9a2-4960-89ce-36af804ece46 60429-771 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET ORAL 20090327 ANDA ANDA079162 Golden State Medical Supply, Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-772_333c0fec-d9a2-4960-89ce-36af804ece46 60429-772 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET ORAL 20090327 ANDA ANDA079162 Golden State Medical Supply, Inc. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-782_0fe4d459-028b-41b2-96a0-93f47f387b92 60429-782 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20060915 ANDA ANDA077661 Golden State Medical Supply, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-783_0fe4d459-028b-41b2-96a0-93f47f387b92 60429-783 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20060915 ANDA ANDA077661 Golden State Medical Supply, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60429-784_a2ea33ae-0527-4f08-810d-89d36b514b55 60429-784 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Golden State Medical Supply, Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 60429-785_a2ea33ae-0527-4f08-810d-89d36b514b55 60429-785 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Golden State Medical Supply, Inc. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 60429-786_a2ea33ae-0527-4f08-810d-89d36b514b55 60429-786 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Golden State Medical Supply, Inc. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 60429-787_a2ea33ae-0527-4f08-810d-89d36b514b55 60429-787 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Golden State Medical Supply, Inc. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 60429-788_a2ea33ae-0527-4f08-810d-89d36b514b55 60429-788 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Golden State Medical Supply, Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 60429-789_a2ea33ae-0527-4f08-810d-89d36b514b55 60429-789 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Golden State Medical Supply, Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 60429-790_a2ea33ae-0527-4f08-810d-89d36b514b55 60429-790 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Golden State Medical Supply, Inc. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 60429-791_a2ea33ae-0527-4f08-810d-89d36b514b55 60429-791 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Golden State Medical Supply, Inc. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 60429-792_a2ea33ae-0527-4f08-810d-89d36b514b55 60429-792 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Golden State Medical Supply, Inc. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 60429-901_29bcca9f-59bc-4c12-afc6-08b03784a9e5 60429-901 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate OINTMENT TOPICAL 19960712 ANDA ANDA074248 Golden State Medical Supply, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60429-902_6fa88705-9405-41a4-abed-6d0892f42e7d 60429-902 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 19960712 ANDA ANDA074249 Golden State Medical Supply, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60429-904_3d3ba937-2108-4ace-b2e3-d881f5201461 60429-904 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19840626 NDA NDA019117 Golden State Medical Supply, Inc. FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60429-907_3d3ba937-2108-4ace-b2e3-d881f5201461 60429-907 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide OINTMENT TOPICAL 19970729 ANDA ANDA074935 Golden State Medical Supply, Inc. FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60429-908_3d3ba937-2108-4ace-b2e3-d881f5201461 60429-908 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide SOLUTION TOPICAL 19961231 ANDA ANDA074799 Golden State Medical Supply, Inc. FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60429-911_1dd310b2-9697-464d-8fee-20d909c367ac 60429-911 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 19990126 ANDA ANDA075090 Golden State Medical Supply, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 60429-932_536811ab-308b-4866-9185-9e4149483512 60429-932 HUMAN PRESCRIPTION DRUG Carbamazepine carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 Golden State Medical Supply, Inc. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 60429-934_536811ab-308b-4866-9185-9e4149483512 60429-934 HUMAN PRESCRIPTION DRUG Carbamazepine carbamazepine TABLET, CHEWABLE ORAL 20001024 ANDA ANDA075687 Golden State Medical Supply, Inc. CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 60429-936_309584ff-4353-44bf-bdaf-851ceb0ca7c3 60429-936 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20050224 ANDA ANDA065152 Golden State Medical Supply, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60429-939_309584ff-4353-44bf-bdaf-851ceb0ca7c3 60429-939 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20050224 ANDA ANDA065152 Golden State Medical Supply, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60429-946_1a6fba4e-ebcd-4b64-98db-47d5a9a54e0d 60429-946 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100201 ANDA ANDA075491 Golden State Medical Supply, Inc BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 60429-947_1a6fba4e-ebcd-4b64-98db-47d5a9a54e0d 60429-947 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100201 ANDA ANDA075491 Golden State Medical Supply, Inc BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 60429-953_feea8d72-5781-46d5-831d-855f478c704d 60429-953 HUMAN PRESCRIPTION DRUG Doxazosin mesylate doxazosin mesylate TABLET ORAL 20040610 ANDA ANDA076161 Golden State Medical Supply, Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60429-954_feea8d72-5781-46d5-831d-855f478c704d 60429-954 HUMAN PRESCRIPTION DRUG Doxazosin mesylate doxazosin mesylate TABLET ORAL 20040610 ANDA ANDA076161 Golden State Medical Supply, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60429-955_feea8d72-5781-46d5-831d-855f478c704d 60429-955 HUMAN PRESCRIPTION DRUG Doxazosin mesylate doxazosin mesylate TABLET ORAL 20040610 ANDA ANDA076161 Golden State Medical Supply, Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60429-956_feea8d72-5781-46d5-831d-855f478c704d 60429-956 HUMAN PRESCRIPTION DRUG Doxazosin mesylate doxazosin mesylate TABLET ORAL 20040610 ANDA ANDA076161 Golden State Medical Supply, Inc. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60429-981_895335b4-1621-426c-ac43-fc75263580f7 60429-981 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20060726 ANDA ANDA077836 Golden State Medical Supply, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 60432-007_f3342bb4-b409-430f-984a-4c6b826858d3 60432-007 HUMAN PRESCRIPTION DRUG Cimetidine Hydrochloride Cimetidine Hydrochloride SOLUTION ORAL 19970312 ANDA ANDA074757 Morton Grove Pharmaceuticals, Inc. CIMETIDINE HYDROCHLORIDE 300 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 60432-037_b3ab88fd-e852-487c-8c75-0d85a88ac33c 60432-037 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL 19961114 ANDA ANDA074602 Morton Grove Pharmaceuticals, Inc. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 60432-038_23a74a75-3a8b-4363-8e6d-6665ad5e4221 60432-038 HUMAN PRESCRIPTION DRUG Generlac Lactulose SOLUTION ORAL 19961031 ANDA ANDA074603 Morton Grove Pharmaceuticals, Inc. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 60432-065_5bfbe66e-28f4-4b1c-8369-af5e6b409afa 60432-065 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20090701 ANDA ANDA065431 Morton Grove Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 250; 62.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 60432-070_4418ed1a-a375-4af8-84e7-55593f47a28d 60432-070 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20131202 ANDA ANDA065420 Morton Grove Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 600; 600 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 60432-092_da22ff0d-ab08-432a-8cf0-3cb9d0b251b9 60432-092 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride SYRUP ORAL 19970212 ANDA ANDA074868 Morton Grove Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 5 mg/5mL Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 60432-093_e85e665f-98ed-4405-b9d8-6773354e66d2 60432-093 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride AMANTADINE HYDROCHLORIDE SOLUTION ORAL 19981224 ANDA ANDA075060 Morton Grove Pharmaceuticals, Inc. AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 60432-126_1d070f34-a9e8-4243-b140-b8c19dfa0169 60432-126 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20050209 ANDA ANDA076721 Morton Grove Pharmaceuticals, Inc. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 60432-129_356d8b31-8995-4fe1-8fa6-67e621cbc248 60432-129 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine SUSPENSION ORAL 20020605 ANDA ANDA075714 Morton Grove Pharmaceuticals, Inc. CARBAMAZEPINE 100 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 60432-131_fc5f5789-51d9-4d9a-82a9-f697d790deaa 60432-131 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20020624 ANDA ANDA040420 Morton Grove Pharmaceuticals, Inc. PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60432-133_ef205af0-967e-40f1-b83e-2cd5e1a52dca 60432-133 HUMAN PRESCRIPTION DRUG Clobetasol Propionate CLOBETASOL PROPIONATE SOLUTION TOPICAL 19981113 ANDA ANDA075205 Morton Grove Pharmaceuticals, Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60432-140_4e33a7bf-17b9-4a58-8a92-1efd3d3b59ac 60432-140 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine SOLUTION ORAL 20050209 ANDA ANDA065133 Morton Grove Pharmaceuticals, Inc. CYCLOSPORINE 100 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 60432-150_5a22b82f-ae45-4340-be59-1a089804ec4a 60432-150 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride SYRUP ORAL 19950309 ANDA ANDA087294 Morton Grove Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 60432-162_8fe1bf3d-6cf3-4209-88d5-466fe139543a 60432-162 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride SOLUTION ORAL 20020829 ANDA ANDA075514 Morton Grove Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60432-212_77f47006-eaee-4152-9095-de097e4aedc1 60432-212 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate PREDNISOLONE SODIUM PHOSPHATE SOLUTION ORAL 20041004 ANDA ANDA076895 Morton Grove Pharmaceuticals, Inc. PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60432-245_b8d4b86e-f34e-49ca-aef0-c1ae99ca95c0 60432-245 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE Acetaminophen and Codeine Phosphate SOLUTION ORAL 19810722 ANDA ANDA087006 Morton Grove Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 60432-264_9b48c448-5f5d-49a9-83e1-4f63e0aefbc3 60432-264 HUMAN PRESCRIPTION DRUG Fluticasone Fluticasone Propionate SPRAY, METERED NASAL 20120109 ANDA ANDA078492 Morton Grove Pharmaceuticals, Inc. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60432-275_11f3ac34-b349-40e4-b390-66cb412be0ce 60432-275 HUMAN PRESCRIPTION DRUG Brompheniramine Maleate, Pseudoephedrine Hydrochloride and DextromethorphanHydrobromide Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide SYRUP ORAL 20100615 ANDA ANDA088811 Morton Grove Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 10; 30 mg/5mL; mg/5mL; mg/5mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] 60432-455_95b344de-7598-4693-afe8-8658ce4579d2 60432-455 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide SYRUP ORAL 19830303 ANDA ANDA088008 Morton Grove Pharmaceuticals, Inc. HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5; 5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII 60432-464_d05d1b9c-ba1d-449d-bced-32b065c1b2dc 60432-464 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION TOPICAL 19821118 ANDA ANDA087872 Morton Grove Pharmaceuticals, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 60432-465_d024d0a7-7068-4851-b9d8-377445ee890c 60432-465 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION TOPICAL 19821118 ANDA ANDA087881 Morton Grove Pharmaceuticals, Inc. LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 60432-466_e8202cfa-3622-4d7c-a999-162ba3139af9 60432-466 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone ELIXIR ORAL 19830727 ANDA ANDA088254 Morton Grove Pharmaceuticals, Inc. DEXAMETHASONE .5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60432-528_4d6ce523-559e-4f79-a007-8be16b405423 60432-528 HUMAN PRESCRIPTION DRUG Selenium Sulfide Selenium Sulfide LOTION TOPICAL 19830901 ANDA ANDA088228 Morton Grove Pharmaceuticals, Inc. SELENIUM SULFIDE 25 mg/mL 60432-537_e7a77b34-4524-4b0b-b014-fa66271042f6 60432-537 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 19950415 ANDA ANDA062512 Morton Grove Pharmaceuticals, Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 60432-539_0b160ef8-3c4f-4985-9c85-b6b9a7731dd8 60432-539 HUMAN PRESCRIPTION DRUG Dexchlorpheniramine Maleate Dexchlorpheniramine Maleate SOLUTION ORAL 19840323 ANDA ANDA088251 Morton Grove Pharmaceuticals, Inc. DEXCHLORPHENIRAMINE MALEATE 2 mg/5mL 60432-560_47121b80-2218-41c2-bd76-70e945fb8d9b 60432-560 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE LOTION TOPICAL 19850401 ANDA ANDA088450 Morton Grove Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE .25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60432-561_44e205df-1296-452a-a985-e01b40343af8 60432-561 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide LOTION TOPICAL 19850403 ANDA ANDA088451 Morton Grove Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60432-604_ed253dc3-b916-4955-8972-8b032297e906 60432-604 HUMAN PRESCRIPTION DRUG Dextromethorphan Hydrobromide and Promethazine Hydrochloride Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL 19850104 ANDA ANDA088864 Morton Grove Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 60432-606_000ad93c-7e83-439b-b9c6-8e8d5942c716 60432-606 HUMAN PRESCRIPTION DRUG Promethazine With Codeine Cough Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 19841217 ANDA ANDA088875 Morton Grove Pharmaceuticals, Inc. CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 60432-608_cc73c388-a23a-407e-a9cc-3d72f5e46f2c 60432-608 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SYRUP ORAL 19821115 ANDA ANDA087953 Morton Grove Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 60432-613_79629566-5f58-4dc7-8b78-3692ac009c04 60432-613 HUMAN PRESCRIPTION DRUG Furosemide Furosemide SOLUTION ORAL 19871002 ANDA ANDA070655 Morton Grove Pharmaceuticals, Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 60432-616_e7efca5c-bbbd-47de-8a86-15656bb661c7 60432-616 HUMAN PRESCRIPTION DRUG Lithium Hydroxide Monohydrate Lithium Hydroxide Monohydrate SOLUTION ORAL 19860521 ANDA ANDA070755 Morton Grove Pharmaceuticals, Inc. LITHIUM HYDROXIDE MONOHYDRATE 8 meq/5mL Mood Stabilizer [EPC] 60432-621_6479c15d-58b4-4769-b11f-1fec90df90b6 60432-621 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid SOLUTION ORAL 19950405 ANDA ANDA070868 Morton Grove Pharmaceuticals, Inc. VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 60432-622_bc573100-6a92-428d-8bec-a3cc167d304d 60432-622 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride SOLUTION ORAL 19971031 ANDA ANDA074703 Morton Grove Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 60432-651_16ccdc71-955e-41a7-bd5e-12cd042c853b 60432-651 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride SOLUTION ORAL 19950209 ANDA ANDA071918 Morton Grove Pharmaceuticals, Inc. DOXEPIN HYDROCHLORIDE 10 mg/mL Tricyclic Antidepressant [EPC] 60432-671_ea1803d1-a0ae-486e-8077-478586fdcf62 60432-671 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN ERYTHROMYCIN SOLUTION TOPICAL 19871023 ANDA ANDA062825 Morton Grove Pharmaceuticals, Inc. ERYTHROMYCIN 20 mg/mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 60432-741_f6e8430c-ef66-488b-adf3-e0a99faa6bc2 60432-741 HUMAN PRESCRIPTION DRUG Acetic Acid ACETIC ACID SOLUTION AURICULAR (OTIC) 19960726 ANDA ANDA040166 Morton Grove Pharmaceuticals, Inc. ACETIC ACID 25 mg/mL 60432-830_4dbf68df-8732-4df7-860a-18b285e23d82 60432-830 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20070618 ANDA ANDA065319 Morton Grove Pharmaceuticals, Inc. AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 60432-831_c4e53048-fc51-47a6-8699-f9914f73d79a 60432-831 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20100318 ANDA ANDA090028 Morton Grove Pharmaceuticals, Inc. LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60432-833_fb487331-c8a4-48c9-a15b-849ac247c0e3 60432-833 HUMAN PRESCRIPTION DRUG Lindane Lindane LOTION TOPICAL 19840816 ANDA ANDA088190 Morton Grove Pharmaceuticals, Inc. LINDANE 10 mg/mL 60432-834_3de32784-ce56-4a8e-8db8-c479aceb6c19 60432-834 HUMAN PRESCRIPTION DRUG Lindane Lindane SHAMPOO TOPICAL 19941212 ANDA ANDA088191 Morton Grove Pharmaceuticals, Inc. LINDANE 10 mg/mL 60432-837_179f9b52-21fe-44c0-88eb-681f75d32201 60432-837 HUMAN PRESCRIPTION DRUG Bromfed DM Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide SYRUP ORAL 20100615 ANDA ANDA088811 Morton Grove Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 10; 30 mg/5mL; mg/5mL; mg/5mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] 60456-576_6ddbe8e7-e68f-463f-94e5-2b0616de5496 60456-576 HUMAN OTC DRUG Antibacterial Foamy Mango TRICLOSAN SOAP TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part333E Carpet Rentals, Inc. TRICLOSAN 3 mg/mL 60505-0003_5d8a3272-ca8b-4fea-6abd-50d0b8be8f3d 60505-0003 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20051207 ANDA ANDA074737 Apotex Corp. CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-0004_5d8a3272-ca8b-4fea-6abd-50d0b8be8f3d 60505-0004 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20051207 ANDA ANDA074737 Apotex Corp. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-0005_5d8a3272-ca8b-4fea-6abd-50d0b8be8f3d 60505-0005 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20051207 ANDA ANDA074737 Apotex Corp. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-0006_5d8a3272-ca8b-4fea-6abd-50d0b8be8f3d 60505-0006 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20051207 ANDA ANDA074737 Apotex Corp. CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-0007_b4853ad8-f70d-cb67-deea-1135f6e7f0e8 60505-0007 HUMAN PRESCRIPTION DRUG DILT-CD diltiazem hydrochloride CAPSULE ORAL 20060830 ANDA ANDA076151 Apotex Corp. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60505-0008_b4853ad8-f70d-cb67-deea-1135f6e7f0e8 60505-0008 HUMAN PRESCRIPTION DRUG DILT-CD diltiazem hydrochloride CAPSULE ORAL 20060830 ANDA ANDA076151 Apotex Corp. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60505-0009_b4853ad8-f70d-cb67-deea-1135f6e7f0e8 60505-0009 HUMAN PRESCRIPTION DRUG DILT-CD diltiazem hydrochloride CAPSULE ORAL 20060830 ANDA ANDA076151 Apotex Corp. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60505-0010_b4853ad8-f70d-cb67-deea-1135f6e7f0e8 60505-0010 HUMAN PRESCRIPTION DRUG DILT-CD diltiazem hydrochloride CAPSULE ORAL 20060830 ANDA ANDA076151 Apotex Corp. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60505-0014_adf5ffa1-f1ea-060a-1e97-044cf833394e 60505-0014 HUMAN PRESCRIPTION DRUG DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20010730 ANDA ANDA074943 Apotex Corp. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60505-0015_adf5ffa1-f1ea-060a-1e97-044cf833394e 60505-0015 HUMAN PRESCRIPTION DRUG DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20010730 ANDA ANDA074943 Apotex Corp. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60505-0016_adf5ffa1-f1ea-060a-1e97-044cf833394e 60505-0016 HUMAN PRESCRIPTION DRUG DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20010730 ANDA ANDA074943 Apotex Corp. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60505-0025_4501ec41-0a9f-b4bf-43cb-40916ce796bf 60505-0025 HUMAN PRESCRIPTION DRUG Ranitidine ranitidine hydrochloride TABLET, FILM COATED ORAL 19970913 ANDA ANDA074680 Apotex Corp RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 60505-0026_4501ec41-0a9f-b4bf-43cb-40916ce796bf 60505-0026 HUMAN PRESCRIPTION DRUG Ranitidine ranitidine hydrochloride TABLET, FILM COATED ORAL 19970913 ANDA ANDA074680 Apotex Corp RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 60505-0027_f7cb5bce-0085-e704-8cfb-74f1f69777b2 60505-0027 HUMAN PRESCRIPTION DRUG Ticlopidine hydrochloride Ticlopidine hydrochloride TABLET, FILM COATED ORAL 19990701 ANDA ANDA075089 Apotex Corp. TICLOPIDINE HYDROCHLORIDE 250 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 60505-0033_7077d31e-7711-8e08-68fd-6feb27db5468 60505-0033 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 19990610 ANDA ANDA075191 Apotex Corp. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 60505-0034_93c32552-ce58-f119-2206-e4f231ee0fa1 60505-0034 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19981001 ANDA ANDA075034 Apotex Corp. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 60505-0039_591918b9-6593-39fb-73dc-2ddace842523 60505-0039 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20030501 ANDA ANDA075419 Apotex Corp. ETODOLAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60505-0040_591918b9-6593-39fb-73dc-2ddace842523 60505-0040 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20030501 ANDA ANDA075419 Apotex Corp. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60505-0041_bcf04cf9-42a0-5628-54d5-08a6ba6eed20 60505-0041 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20030501 ANDA ANDA076004 Apotex Corp. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60505-0042_1ed687b5-28d0-a204-088d-bec9cb9b309d 60505-0042 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20060320 ANDA ANDA075677 Apotex Corp. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 60505-0055_76737f47-6b8b-3297-48c3-282d7acfb1eb 60505-0055 HUMAN PRESCRIPTION DRUG SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE CAPSULE ORAL 19970715 ANDA ANDA075321 Apotex Corp. SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] 60505-0065_6858f7ae-8277-7dde-2f5a-1c426b942782 60505-0065 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 Apotex Corp OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 60505-0080_fad9271e-3d34-a358-759d-312d54435b4c 60505-0080 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Apotex Corp. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 60505-0081_fad9271e-3d34-a358-759d-312d54435b4c 60505-0081 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Apotex Corp. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC] 60505-0082_fad9271e-3d34-a358-759d-312d54435b4c 60505-0082 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Apotex Corp. SOTALOL HYDROCHLORIDE 240 mg/1 Antiarrhythmic [EPC] 60505-0083_5272f0d1-25e3-df90-2d80-88f6c0fa49a3 60505-0083 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Apotex Corp. PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-0084_5272f0d1-25e3-df90-2d80-88f6c0fa49a3 60505-0084 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Apotex Corp. PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-0093_e05d83de-d6f3-c70e-4b27-3a9fa9526d32 60505-0093 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Apotex Corp. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60505-0094_e05d83de-d6f3-c70e-4b27-3a9fa9526d32 60505-0094 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Apotex Corp. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60505-0095_e05d83de-d6f3-c70e-4b27-3a9fa9526d32 60505-0095 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Apotex Corp. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60505-0096_e05d83de-d6f3-c70e-4b27-3a9fa9526d32 60505-0096 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Apotex Corp. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60505-0097_5272f0d1-25e3-df90-2d80-88f6c0fa49a3 60505-0097 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Apotex Corp. PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-0101_5272f0d1-25e3-df90-2d80-88f6c0fa49a3 60505-0101 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Apotex Corp. PAROXETINE HYDROCHLORIDE ANHYDROUS 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-0102_bcf04cf9-42a0-5628-54d5-08a6ba6eed20 60505-0102 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20030501 ANDA ANDA076004 Apotex Corp. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60505-0112_1e0c755a-d3f1-671b-9e5d-61234fdf6c94 60505-0112 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Apotex Corp. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-0113_1e0c755a-d3f1-671b-9e5d-61234fdf6c94 60505-0113 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Apotex Corp. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-0114_1e0c755a-d3f1-671b-9e5d-61234fdf6c94 60505-0114 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Apotex Corp. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-0115_121ff962-1f7c-db33-f6e5-f8e539c3d526 60505-0115 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20010412 ANDA ANDA075498 Apotex Corp. TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60505-0116_121ff962-1f7c-db33-f6e5-f8e539c3d526 60505-0116 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20010412 ANDA ANDA075498 Apotex Corp. TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60505-0117_121ff962-1f7c-db33-f6e5-f8e539c3d526 60505-0117 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20010412 ANDA ANDA075498 Apotex Corp. TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60505-0118_121ff962-1f7c-db33-f6e5-f8e539c3d526 60505-0118 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20010412 ANDA ANDA075498 Apotex Corp. TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60505-0128_1ab5d9f1-9bbe-315d-6d1d-7d70244efbf1 60505-0128 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20081009 ANDA ANDA077120 Apotex Corp. CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 60505-0129_1ab5d9f1-9bbe-315d-6d1d-7d70244efbf1 60505-0129 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20081009 ANDA ANDA077120 Apotex Corp. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 60505-0130_1ab5d9f1-9bbe-315d-6d1d-7d70244efbf1 60505-0130 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20081009 ANDA ANDA077120 Apotex Corp. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 60505-0131_64972eea-4765-b1aa-fdab-a4d46e45b007 60505-0131 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20040616 ANDA ANDA076212 Apotex Corp. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 60505-0132_64972eea-4765-b1aa-fdab-a4d46e45b007 60505-0132 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20040616 ANDA ANDA076212 Apotex Corp. CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 60505-0133_a82d1ce4-3c34-ffe8-3349-a53e3a12081e 60505-0133 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED ORAL 20020529 ANDA ANDA065040 Apotex Corp. CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 60505-0134_a82d1ce4-3c34-ffe8-3349-a53e3a12081e 60505-0134 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED ORAL 20020529 ANDA ANDA065040 Apotex Corp. CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 60505-0135_26427b94-217b-9e3e-aaea-afa54f1bfe0d 60505-0135 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 20060320 ANDA ANDA076561 Apotex Corp DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60505-0141_ff50cc7e-c33d-a0b3-a857-d7f422486ca6 60505-0141 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 Apotex Corp. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 60505-0142_ff50cc7e-c33d-a0b3-a857-d7f422486ca6 60505-0142 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 Apotex Corp. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 60505-0145_6858f7ae-8277-7dde-2f5a-1c426b942782 60505-0145 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 Apotex Corp OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 60505-0146_6858f7ae-8277-7dde-2f5a-1c426b942782 60505-0146 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA076048 Apotex Corp OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 60505-0147_b91700ac-cb4f-f19d-53ad-505fa5634309 60505-0147 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20050124 ANDA ANDA076471 Apotex Corp. LORATADINE 10 mg/1 60505-0157_c54a0d33-068b-9206-2488-2b434ea0a008 60505-0157 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20060117 ANDA ANDA076143 Apotex Corp BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 60505-0158_c54a0d33-068b-9206-2488-2b434ea0a008 60505-0158 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20060117 ANDA ANDA076143 Apotex Corp BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 60505-0159_fad9271e-3d34-a358-759d-312d54435b4c 60505-0159 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Apotex Corp. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC] 60505-0164_c66a300d-a607-280b-1a0f-eecdc18dce72 60505-0164 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET ORAL 20010710 ANDA ANDA075902 Apotex Corp FLUVOXAMINE MALEATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-0165_c66a300d-a607-280b-1a0f-eecdc18dce72 60505-0165 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET ORAL 20010710 ANDA ANDA075902 Apotex Corp FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-0166_c66a300d-a607-280b-1a0f-eecdc18dce72 60505-0166 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET ORAL 20010710 ANDA ANDA075902 Apotex Corp FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-0168_2ad4c6a8-9113-7871-413f-411585a95aca 60505-0168 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Apotex Corp. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60505-0169_2ad4c6a8-9113-7871-413f-411585a95aca 60505-0169 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Apotex Corp. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60505-0170_2ad4c6a8-9113-7871-413f-411585a95aca 60505-0170 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Apotex Corp. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60505-0171_8b6db104-528b-016b-46bf-6cbf48e37c14 60505-0171 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, COATED ORAL 20020710 ANDA ANDA075981 Apotex Corp. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 60505-0176_e23b8684-5fcd-658d-459d-e4e1e34ccb4a 60505-0176 HUMAN PRESCRIPTION DRUG oxaprozin oxaprozin TABLET, FILM COATED ORAL 20040903 ANDA ANDA075987 Apotex Corp. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60505-0180_d0b10093-cdc8-2c6c-09c5-aee0500c49fe 60505-0180 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA076882 Apotex Corp SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-0181_d0b10093-cdc8-2c6c-09c5-aee0500c49fe 60505-0181 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA076882 Apotex Corp SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-0182_d0b10093-cdc8-2c6c-09c5-aee0500c49fe 60505-0182 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA076882 Apotex Corp SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-0183_f8b4576c-3ca2-97cc-34e6-db4cdbecab31 60505-0183 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20020901 ANDA ANDA075948 Apotex Corp. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 60505-0184_4b793982-b866-7f05-06f3-ffceedef6218 60505-0184 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20080626 ANDA ANDA076102 Apotex Corp. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-0185_4b793982-b866-7f05-06f3-ffceedef6218 60505-0185 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20080218 ANDA ANDA076102 Apotex Corp. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-0186_4b793982-b866-7f05-06f3-ffceedef6218 60505-0186 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20080417 ANDA ANDA076102 Apotex Corp. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-0187_4b793982-b866-7f05-06f3-ffceedef6218 60505-0187 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20080625 ANDA ANDA076102 Apotex Corp. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-0188_4b793982-b866-7f05-06f3-ffceedef6218 60505-0188 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20021009 ANDA ANDA076102 Apotex Corp. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-0189_4b793982-b866-7f05-06f3-ffceedef6218 60505-0189 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20080122 ANDA ANDA076102 Apotex Corp. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-0190_19c3ceb3-f5d8-4480-bec4-7500411a047e 60505-0190 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20111207 ANDA ANDA090666 Apotex Corp. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 60505-0191_19c3ceb3-f5d8-4480-bec4-7500411a047e 60505-0191 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20111207 ANDA ANDA090666 Apotex Corp. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 60505-0192_19c3ceb3-f5d8-4480-bec4-7500411a047e 60505-0192 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20111207 ANDA ANDA090666 Apotex Corp. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 60505-0193_63959fdd-dd47-8779-8404-c5eb48b03ff9 60505-0193 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070524 ANDA ANDA076719 Apotex Corp. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 60505-0194_63959fdd-dd47-8779-8404-c5eb48b03ff9 60505-0194 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070524 ANDA ANDA076719 Apotex Corp. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 60505-0195_63959fdd-dd47-8779-8404-c5eb48b03ff9 60505-0195 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070524 ANDA ANDA076719 Apotex Corp. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 60505-0205_fe6f1b68-41bd-df79-4873-af505ded2e02 60505-0205 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20080718 ANDA ANDA076674 Apotex Corp. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-0206_fe6f1b68-41bd-df79-4873-af505ded2e02 60505-0206 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20080724 ANDA ANDA076674 Apotex Corp. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-0207_fe6f1b68-41bd-df79-4873-af505ded2e02 60505-0207 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20080724 ANDA ANDA076674 Apotex Corp. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-0208_fb11d0ea-f840-2d73-92ae-bfea5544fbde 60505-0208 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril maleate and hydrochlorothiazide TABLET ORAL 20070619 ANDA ANDA076486 Apotex Corp. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 5; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-0209_fb11d0ea-f840-2d73-92ae-bfea5544fbde 60505-0209 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril maleate and hydrochlorothiazide TABLET ORAL 20070619 ANDA ANDA076486 Apotex Corp. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-0210_c7358515-6ae6-8f89-6958-72dd9786d5cb 60505-0210 HUMAN PRESCRIPTION DRUG DILTZAC Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090203 ANDA ANDA076395 Apotex Corp. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60505-0211_c7358515-6ae6-8f89-6958-72dd9786d5cb 60505-0211 HUMAN PRESCRIPTION DRUG DILTZAC Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090203 ANDA ANDA076395 Apotex Corp. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60505-0212_c7358515-6ae6-8f89-6958-72dd9786d5cb 60505-0212 HUMAN PRESCRIPTION DRUG DILTZAC Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090203 ANDA ANDA076395 Apotex Corp. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60505-0213_c7358515-6ae6-8f89-6958-72dd9786d5cb 60505-0213 HUMAN PRESCRIPTION DRUG DILTZAC Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090203 ANDA ANDA076395 Apotex Corp. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60505-0214_c7358515-6ae6-8f89-6958-72dd9786d5cb 60505-0214 HUMAN PRESCRIPTION DRUG DILTZAC Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090203 ANDA ANDA076395 Apotex Corp. DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60505-0222_0a632e54-1125-6600-1b7a-da9c83853440 60505-0222 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030909 ANDA ANDA076214 Apotex Corp. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 60505-0223_0a632e54-1125-6600-1b7a-da9c83853440 60505-0223 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030909 ANDA ANDA076214 Apotex Corp. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC] 60505-0224_0a632e54-1125-6600-1b7a-da9c83853440 60505-0224 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030909 ANDA ANDA076214 Apotex Corp. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC] 60505-0232_1decd030-d17c-71b3-d349-09faa0a56646 60505-0232 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20050606 ANDA ANDA076894 Apotex Corp. TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 60505-0233_1decd030-d17c-71b3-d349-09faa0a56646 60505-0233 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20050606 ANDA ANDA076894 Apotex Corp. TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 60505-0234_1decd030-d17c-71b3-d349-09faa0a56646 60505-0234 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20050606 ANDA ANDA076894 Apotex Corp. TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 60505-0235_1decd030-d17c-71b3-d349-09faa0a56646 60505-0235 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20050606 ANDA ANDA076894 Apotex Corp. TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 60505-0247_7826636a-642f-38d9-0394-6e789f49dba7 60505-0247 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Apotex Corp. MIRTAZAPINE 15 mg/1 60505-0248_7826636a-642f-38d9-0394-6e789f49dba7 60505-0248 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Apotex Corp. MIRTAZAPINE 30 mg/1 60505-0249_7826636a-642f-38d9-0394-6e789f49dba7 60505-0249 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Apotex Corp. MIRTAZAPINE 45 mg/1 60505-0251_64087f97-084b-61d8-34cb-2f5a599b6fa3 60505-0251 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 Apotex Corp. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 60505-0252_64087f97-084b-61d8-34cb-2f5a599b6fa3 60505-0252 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 Apotex Corp. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 60505-0253_f283497c-525b-d6eb-bd01-f6ebd5b8f226 60505-0253 HUMAN PRESCRIPTION DRUG Clopidogrel clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA076274 Apotex Corp. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 60505-0257_59ba7fff-787d-4ba7-4078-b335868ed697 60505-0257 HUMAN PRESCRIPTION DRUG Desmopressin Acetate desmopressin acetate TABLET ORAL 20060307 ANDA ANDA077414 Apotex Corp. DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 60505-0258_59ba7fff-787d-4ba7-4078-b335868ed697 60505-0258 HUMAN PRESCRIPTION DRUG Desmopressin Acetate desmopressin acetate TABLET ORAL 20060307 ANDA ANDA077414 Apotex Corp. DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 60505-0260_19c3ceb3-f5d8-4480-bec4-7500411a047e 60505-0260 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20041216 ANDA ANDA076706 Apotex Corp. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 60505-0261_0d4f90e0-fcee-1f05-bb6c-727310341863 60505-0261 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20140821 ANDA ANDA078794 Apotex Corp. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-0262_0d4f90e0-fcee-1f05-bb6c-727310341863 60505-0262 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20140821 ANDA ANDA078794 Apotex Corp. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-0263_0d4f90e0-fcee-1f05-bb6c-727310341863 60505-0263 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20140821 ANDA ANDA078794 Apotex Corp. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-0264_0d4f90e0-fcee-1f05-bb6c-727310341863 60505-0264 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20140821 ANDA ANDA078794 Apotex Corp. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-0265_4bd910c6-9db6-985a-33a0-6e17eba171ff 60505-0265 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20060416 ANDA ANDA077128 Apotex Corp BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60505-0266_4bd910c6-9db6-985a-33a0-6e17eba171ff 60505-0266 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20060416 ANDA ANDA077128 Apotex Corp BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60505-0267_4bd910c6-9db6-985a-33a0-6e17eba171ff 60505-0267 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20060421 ANDA ANDA077128 Apotex Corp BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60505-0268_4bd910c6-9db6-985a-33a0-6e17eba171ff 60505-0268 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20060421 ANDA ANDA077128 Apotex Corp BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60505-0271_2e7de2ba-031e-5d77-ef87-a2503c5934d0 60505-0271 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET ORAL 20080609 ANDA ANDA078454 Apotex Corp. MOEXIPRIL HYDROCHLORIDE 7.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-0272_2e7de2ba-031e-5d77-ef87-a2503c5934d0 60505-0272 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET ORAL 20080609 ANDA ANDA078454 Apotex Corp. MOEXIPRIL HYDROCHLORIDE 15 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-0363_7bc4742b-6f34-2c2d-95b9-d70f8358e55f 60505-0363 HUMAN PRESCRIPTION DRUG Ofloxacin Otic Ofloxacin SOLUTION AURICULAR (OTIC) 20040514 ANDA ANDA076527 Apotex Corp. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 60505-0380_40648939-c609-2ccd-cb80-b98f47e3364f 60505-0380 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20090729 ANDA ANDA077719 Apotex Corp. RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] 60505-0381_55936b58-8d5d-6e20-4e76-c1c3b0737785 60505-0381 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron hydrochloride SOLUTION ORAL 20080313 ANDA ANDA078127 Apotex Corp ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 60505-0399_830560a1-630a-beda-04a8-e770a6e461bd 60505-0399 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION TOPICAL 20140528 ANDA ANDA202027 Apotex Corp. DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60505-0402_b06b2299-84a6-c7f8-7ec2-c89c3b359892 60505-0402 HUMAN PRESCRIPTION DRUG PAXIL paroxetine hydrochloride SUSPENSION ORAL 20110101 NDA NDA020710 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-0501_885c8419-6bf4-96b4-4bcb-67f7f6446218 60505-0501 HUMAN PRESCRIPTION DRUG Imiquimod imiquimod CREAM TOPICAL 20120914 ANDA ANDA091308 Apotex Corp. IMIQUIMOD 50 mg/1000mg Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 60505-0560_4ebe9909-6509-ab0a-931c-e70bd210125f 60505-0560 HUMAN PRESCRIPTION DRUG Ofloxacin Ophthalmic ofloxacin SOLUTION OPHTHALMIC 20040514 ANDA ANDA076513 Apotex Corp. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 60505-0562_261a59a6-2e07-0fc8-2566-434735234432 60505-0562 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL; RECTAL 20050126 ANDA ANDA076645 Apotex Corp. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 60505-0565_55eddb0c-25d2-7825-5f6c-0e8bd671ca1e 60505-0565 HUMAN PRESCRIPTION DRUG Latanoprost Latanoprost SOLUTION OPHTHALMIC 20110322 ANDA ANDA077697 Apotex Corp. LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 60505-0570_8e296920-686c-ec04-a044-632974bbbc80 60505-0570 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION OPHTHALMIC 20091207 ANDA ANDA077308 Apotex Corp. KETOROLAC TROMETHAMINE 4 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60505-0578_da5f9289-b3c9-ff97-4c98-7967866fd0e6 60505-0578 HUMAN PRESCRIPTION DRUG AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS INTRAOCULAR 20091201 ANDA ANDA078621 Apotex Corp. AZELASTINE HYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 60505-0584_eed9aa31-2d42-7087-271c-b6aff283d09b 60505-0584 HUMAN PRESCRIPTION DRUG Epinastine Hydrochloride Epinastine Hydrochloride SOLUTION OPHTHALMIC 20111031 ANDA ANDA090919 Apotex Corp. EPINASTINE HYDROCHLORIDE .5 mg/mL Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 60505-0595_4434b87d-0afe-fd68-32c1-73bd201a32ca 60505-0595 HUMAN PRESCRIPTION DRUG Bromfenac Ophthalmic Solution, 0.09% Bromfenac Ophthalmic Solution, 0.09% SOLUTION/ DROPS OPHTHALMIC 20140623 ANDA ANDA202620 Apotex Corp. BROMFENAC SODIUM 1.035 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60505-0596_b4eb0f62-5919-1b2a-7af7-d641759f0ac7 60505-0596 HUMAN PRESCRIPTION DRUG Bromfenac bromfenac SOLUTION/ DROPS OPHTHALMIC 20140619 ANDA ANDA202435 Apotex Corp BROMFENAC SODIUM .9 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60505-0597_45c57114-5f79-4d70-9423-7b87fb554971 60505-0597 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20110715 ANDA ANDA077259 Apotex Corp. TIMOLOL MALEATE 2.5 mg/mL 60505-0598_45c57114-5f79-4d70-9423-7b87fb554971 60505-0598 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20110715 ANDA ANDA077259 Apotex Corp. TIMOLOL MALEATE 5 mg/mL 60505-0679_f55a5377-bebd-4087-b131-dcee7562cdb2 60505-0679 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050802 ANDA ANDA065232 Apotex Corporation CEFTRIAXONE SODIUM 100 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-0681_0ade324c-f975-41df-8806-2ce04e11371f 60505-0681 HUMAN PRESCRIPTION DRUG Cefepime CEFEPIME INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20070618 ANDA ANDA065369 Apotex Corporation CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-0686_e3a10436-2986-4663-8eee-fe9e94904ccb 60505-0686 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN and TAZOBACTAM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20090921 ANDA ANDA065386 Apotex Corporation PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 60505-0687_e3a10436-2986-4663-8eee-fe9e94904ccb 60505-0687 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN and TAZOBACTAM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20090921 ANDA ANDA065386 Apotex Corporation PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 60505-0688_e3a10436-2986-4663-8eee-fe9e94904ccb 60505-0688 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN and TAZOBACTAM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20090921 ANDA ANDA065386 Apotex Corporation PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 60505-0748_6d2fe6ec-eb91-49d3-893e-796f83656ac0 60505-0748 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051007 ANDA ANDA065226 Apotex Corp CEFAZOLIN SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-0749_6d2fe6ec-eb91-49d3-893e-796f83656ac0 60505-0749 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051007 ANDA ANDA065226 Apotex Corp CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-0750_ac6a7877-d725-4613-9e41-dd7331c93243 60505-0750 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 Apotex Corporation CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-0751_ac6a7877-d725-4613-9e41-dd7331c93243 60505-0751 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 Apotex Corporation CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-0752_ac6a7877-d725-4613-9e41-dd7331c93243 60505-0752 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 Apotex Corporation CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-0753_ac6a7877-d725-4613-9e41-dd7331c93243 60505-0753 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 Apotex Corporation CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-0759_a6602b25-55b4-433e-b602-0bfc1e772aa3 60505-0759 HUMAN PRESCRIPTION DRUG Cefoxitin CEFOXITIN INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060213 ANDA ANDA065313 Apotex Corporation CEFOXITIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-0760_a6602b25-55b4-433e-b602-0bfc1e772aa3 60505-0760 HUMAN PRESCRIPTION DRUG Cefoxitin CEFOXITIN INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060213 ANDA ANDA065313 Apotex Corporation CEFOXITIN SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-0761_69dd10a7-c802-412d-8977-0eb4e8238437 60505-0761 HUMAN PRESCRIPTION DRUG Cefoxitin CEFOXITIN INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060213 ANDA ANDA065312 Apotex Corporation CEFOXITIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-0769_253af1f8-6a2f-4f81-bb9b-56dde756afe4 60505-0769 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060613 ANDA ANDA065247 Apotex Corp CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-0773_8f78d498-49f0-485a-b07b-678ff9aa888f 60505-0773 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN and TAZOBACTAM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091005 ANDA ANDA065446 Apotex Corporation PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 36; 4.5 g/152mL; g/152mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 60505-0813_fd1083f2-df15-141b-1d53-42a2f39ef317 60505-0813 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate Butorphanol Tartrate SOLUTION NASAL 20021204 ANDA ANDA075499 Apotex Corp. BUTORPHANOL TARTRATE 10 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV 60505-0815_02785654-305c-82ab-08db-8ce8b0e42440 60505-0815 HUMAN PRESCRIPTION DRUG DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE SPRAY NASAL 20050127 ANDA ANDA076703 Apotex Corp. DESMOPRESSIN ACETATE 10 ug/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 60505-0820_9db90eb8-7c60-e73a-a8e2-12d304550c45 60505-0820 HUMAN PRESCRIPTION DRUG BUDESONIDE BUDESONIDE SUSPENSION RESPIRATORY (INHALATION) 20090330 ANDA ANDA078202 Apotex Corp. BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60505-0821_9db90eb8-7c60-e73a-a8e2-12d304550c45 60505-0821 HUMAN PRESCRIPTION DRUG BUDESONIDE BUDESONIDE SUSPENSION RESPIRATORY (INHALATION) 20090330 ANDA ANDA078202 Apotex Corp. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60505-0823_af648eda-ff07-596c-b25a-d1d3d57a4890 60505-0823 HUMAN PRESCRIPTION DRUG Calcitonin Salmon Calcitonin Salmon SPRAY, METERED NASAL 20081209 ANDA ANDA076396 Apotex Corp. CALCITONIN SALMON 200 [iU]/1 Calcitonin [Chemical/Ingredient],Calcitonin [EPC] 60505-0829_34f3376d-16fa-e5a9-fcc2-1a74bf9fb289 60505-0829 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20070919 ANDA ANDA077538 Apotex Corp. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60505-0833_5396e6ff-7f50-9762-d952-5b7e76df5f2f 60505-0833 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride azelastine hydrochloride SPRAY, METERED NASAL 20100301 ANDA ANDA077954 Apotex Corp. AZELASTINE HYDROCHLORIDE 137 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 60505-0834_0ade324c-f975-41df-8806-2ce04e11371f 60505-0834 HUMAN PRESCRIPTION DRUG Cefepime CEFEPIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070618 ANDA ANDA065369 Apotex Corporation CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-0839_d98ba7b4-65f6-e280-4081-9da5398f8fb5 60505-0839 HUMAN PRESCRIPTION DRUG Budesonide Nasal Budesonide SPRAY, METERED NASAL 20140512 ANDA ANDA078949 Apotex Corp. BUDESONIDE 32 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60505-0845_6075ec0c-f3b8-4f59-009e-d34ad76d1717 60505-0845 HUMAN PRESCRIPTION DRUG Olopatadine Hydrochloride olopatadine hydrochloride SPRAY, METERED NASAL 20141027 ANDA ANDA091572 Apotex Corp. OLOPATADINE HYDROCHLORIDE 665 ug/1 Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 60505-0847_47744897-88e2-d6a8-766d-904a5be5c6da 60505-0847 HUMAN PRESCRIPTION DRUG Fluticasone Propionate fluticasone propionate SPRAY, METERED NASAL 20091209 ANDA ANDA077538 Apotex Corp. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60505-0848_bb4d282f-234c-9ee0-f229-ebcbb08f0c7b 60505-0848 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride Azelastine Hydrochloride SPRAY, METERED NASAL 20140707 ANDA ANDA201846 Apotex Corp. AZELASTINE HYDROCHLORIDE 205.5 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 60505-1003_2ccf65f3-660f-5a79-848f-b1ba6ea74d03 60505-1003 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION/ DROPS OPHTHALMIC 20091207 ANDA ANDA076109 Apotex Corp. KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60505-1201_cdeeec9b-bf2a-f606-e4f0-3589fcb45968 60505-1201 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20021002 ANDA ANDA065069 Apotex Corp. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-1202_cdeeec9b-bf2a-f606-e4f0-3589fcb45968 60505-1202 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20021002 ANDA ANDA065069 Apotex Corp. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-1308_86b20dfa-287d-b8c7-dd32-4e5c607caef0 60505-1308 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20050419 ANDA ANDA076896 Apotex Corp CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 60505-1309_86b20dfa-287d-b8c7-dd32-4e5c607caef0 60505-1309 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20050419 ANDA ANDA076896 Apotex Corp CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 60505-1310_86b20dfa-287d-b8c7-dd32-4e5c607caef0 60505-1310 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20080313 ANDA ANDA076896 Apotex Corp CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 60505-1320_da7b8522-674f-6a8e-397d-4aa77da100f3 60505-1320 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20060912 ANDA ANDA077746 Apotex Corp MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 60505-1321_da7b8522-674f-6a8e-397d-4aa77da100f3 60505-1321 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20060912 ANDA ANDA077746 Apotex Corp MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 60505-1323_2ad4c6a8-9113-7871-413f-411585a95aca 60505-1323 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Apotex Corp. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60505-1325_da7b8522-674f-6a8e-397d-4aa77da100f3 60505-1325 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20060912 ANDA ANDA077746 Apotex Corp MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 60505-1329_19c3ceb3-f5d8-4480-bec4-7500411a047e 60505-1329 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20051229 ANDA ANDA076706 Apotex Corp. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 60505-2502_fe1ea007-6d6e-1d29-5bd0-6ac7174b6136 60505-2502 HUMAN PRESCRIPTION DRUG LEFLUNOMIDE LEFLUNOMIDE TABLET ORAL 20050913 ANDA ANDA077090 Apotex Corp. LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] 60505-2503_fe1ea007-6d6e-1d29-5bd0-6ac7174b6136 60505-2503 HUMAN PRESCRIPTION DRUG LEFLUNOMIDE LEFLUNOMIDE TABLET ORAL 20050913 ANDA ANDA077090 Apotex Corp. LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] 60505-2504_5f11e599-552d-6094-320b-bce90e234a52 60505-2504 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20041129 ANDA ANDA076795 Apotex Corp LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 60505-2510_91de48b6-a7cc-438b-89ad-50ae3cb5ee67 60505-2510 HUMAN PRESCRIPTION DRUG FOSINOPRIL Na FOSINOPRIL Sodium TABLET ORAL 20050518 ANDA ANDA076906 Apotex Corp. FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-2511_91de48b6-a7cc-438b-89ad-50ae3cb5ee67 60505-2511 HUMAN PRESCRIPTION DRUG FOSINOPRIL Na FOSINOPRIL Sodium TABLET ORAL 20050518 ANDA ANDA076906 Apotex Corp. FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-2512_91de48b6-a7cc-438b-89ad-50ae3cb5ee67 60505-2512 HUMAN PRESCRIPTION DRUG FOSINOPRIL Na FOSINOPRIL Sodium TABLET ORAL 20050518 ANDA ANDA076906 Apotex Corp. FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-2518_e8d2ece1-7be8-2124-62a5-7ab01b5f92f4 60505-2518 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20110801 ANDA ANDA077046 Apotex Corp. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-2519_e8d2ece1-7be8-2124-62a5-7ab01b5f92f4 60505-2519 HUMAN PRESCRIPTION DRUG Citalopram citalopram hydrobromide TABLET, FILM COATED ORAL 20110801 ANDA ANDA077046 Apotex Corp. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-2520_e8d2ece1-7be8-2124-62a5-7ab01b5f92f4 60505-2520 HUMAN PRESCRIPTION DRUG Citalopram citalopram hydrobromide TABLET, FILM COATED ORAL 20110801 ANDA ANDA077046 Apotex Corp. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-2521_ae576c70-5b30-f19a-8d00-8561a8a93c32 60505-2521 HUMAN PRESCRIPTION DRUG cilostazol cilostazol TABLET ORAL 20111018 ANDA ANDA077030 Apotex Corp. CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 60505-2522_ae576c70-5b30-f19a-8d00-8561a8a93c32 60505-2522 HUMAN PRESCRIPTION DRUG cilostazol cilostazol TABLET ORAL 20111018 ANDA ANDA077030 Apotex Corp. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 60505-2526_5e67c55c-985d-bac1-788d-a23eebf6c907 60505-2526 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20140203 ANDA ANDA077667 Apotex Corp. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 60505-2527_5e67c55c-985d-bac1-788d-a23eebf6c907 60505-2527 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20140203 ANDA ANDA077667 Apotex Corp. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 60505-2528_c0ad8ab7-15fe-5068-d8c0-d45a0bb576d5 60505-2528 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Apotex Corp. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 60505-2529_c0ad8ab7-15fe-5068-d8c0-d45a0bb576d5 60505-2529 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Apotex Corp. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 60505-2530_c0ad8ab7-15fe-5068-d8c0-d45a0bb576d5 60505-2530 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Apotex Corp. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 60505-2531_c0ad8ab7-15fe-5068-d8c0-d45a0bb576d5 60505-2531 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Apotex Corp. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 60505-2532_2a094b16-3416-f9a3-1935-0c6361c4ae57 60505-2532 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20080509 ANDA ANDA065327 Apotex Corp CEFPROZIL 250 mg/1 60505-2533_2a094b16-3416-f9a3-1935-0c6361c4ae57 60505-2533 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20080509 ANDA ANDA065327 Apotex Corp CEFPROZIL 500 mg/1 60505-2534_a875d118-8479-89d7-8ae3-0599f57ddf07 60505-2534 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20080409 ANDA ANDA077747 Apotex Corp. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-2535_a875d118-8479-89d7-8ae3-0599f57ddf07 60505-2535 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20080409 ANDA ANDA077747 Apotex Corp. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-2536_a875d118-8479-89d7-8ae3-0599f57ddf07 60505-2536 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20080409 ANDA ANDA077747 Apotex Corp. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-2539_e32e7e79-c330-0f35-b6dc-bed9743dbfa2 60505-2539 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET ORAL 20090706 ANDA ANDA065333 Apotex Corp. AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 60505-2540_e32e7e79-c330-0f35-b6dc-bed9743dbfa2 60505-2540 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET ORAL 20090706 ANDA ANDA065333 Apotex Corp. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 60505-2541_e32e7e79-c330-0f35-b6dc-bed9743dbfa2 60505-2541 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET ORAL 20090706 ANDA ANDA065317 Apotex Corp. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 60505-2542_52b7eaa1-8ade-dd85-5648-ed6d8d31f021 60505-2542 HUMAN PRESCRIPTION DRUG Galantamine galantamine hydrobromide TABLET, FILM COATED ORAL 20121105 ANDA ANDA077781 Apotex Corp. GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 60505-2543_52b7eaa1-8ade-dd85-5648-ed6d8d31f021 60505-2543 HUMAN PRESCRIPTION DRUG Galantamine galantamine hydrobromide TABLET, FILM COATED ORAL 20121105 ANDA ANDA077781 Apotex Corp. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 60505-2544_52b7eaa1-8ade-dd85-5648-ed6d8d31f021 60505-2544 HUMAN PRESCRIPTION DRUG Galantamine galantamine hydrobromide TABLET, FILM COATED ORAL 20121105 ANDA ANDA077781 Apotex Corp. GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 60505-2545_026ed15d-c1ff-cbc9-6d3c-2ce9acf5c66f 60505-2545 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077642 Apotex Corp. ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-2546_026ed15d-c1ff-cbc9-6d3c-2ce9acf5c66f 60505-2546 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077642 Apotex Corp. ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-2547_026ed15d-c1ff-cbc9-6d3c-2ce9acf5c66f 60505-2547 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077642 Apotex Corp. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-2551_c5d2a3ad-2e5e-14f3-44a4-bee0b7a76b86 60505-2551 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20060915 ANDA ANDA077661 Apotex Corp. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-2552_c5d2a3ad-2e5e-14f3-44a4-bee0b7a76b86 60505-2552 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20060915 ANDA ANDA077661 Apotex Corp. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-2553_2c67b478-e382-15a5-f7d1-46b80cd6a6de 60505-2553 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060728 ANDA ANDA077882 Apotex Corp. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60505-2554_2c67b478-e382-15a5-f7d1-46b80cd6a6de 60505-2554 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060728 ANDA ANDA077882 Apotex Corp. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60505-2575_fed795ea-8d30-3839-6861-d6636f4c9e69 60505-2575 HUMAN PRESCRIPTION DRUG Balsalazide Disodium Balsalazide Disodium CAPSULE ORAL 20071228 ANDA ANDA077883 Apotex Corp. BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 60505-2578_7699e0c0-9dbc-12d5-207e-6c7fede52d3a 60505-2578 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Apotex Corp. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60505-2579_7699e0c0-9dbc-12d5-207e-6c7fede52d3a 60505-2579 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Apotex Corp. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60505-2580_7699e0c0-9dbc-12d5-207e-6c7fede52d3a 60505-2580 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Apotex Corp. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60505-2581_6cf5afc8-4ec1-e088-2a7f-2d0b9bcc1d64 60505-2581 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20110718 ANDA ANDA065507 Apotex Corp. AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 60505-2582_6cf5afc8-4ec1-e088-2a7f-2d0b9bcc1d64 60505-2582 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20110718 ANDA ANDA065509 Apotex Corp. AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 60505-2583_15e0d657-59c7-dc7a-dca5-7093017dd0d2 60505-2583 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20110713 ANDA ANDA065508 Apotex Corp. AZITHROMYCIN DIHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 60505-2584_145e2cd1-e5d3-d27a-3d6c-a8d531caa37b 60505-2584 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20080922 ANDA ANDA077953 Apotex Corp RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 60505-2585_145e2cd1-e5d3-d27a-3d6c-a8d531caa37b 60505-2585 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20080922 ANDA ANDA077953 Apotex Corp RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 60505-2586_145e2cd1-e5d3-d27a-3d6c-a8d531caa37b 60505-2586 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20080922 ANDA ANDA077953 Apotex Corp RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 60505-2587_145e2cd1-e5d3-d27a-3d6c-a8d531caa37b 60505-2587 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20080922 ANDA ANDA077953 Apotex Corp RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 60505-2588_145e2cd1-e5d3-d27a-3d6c-a8d531caa37b 60505-2588 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20080922 ANDA ANDA077953 Apotex Corp RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 60505-2589_145e2cd1-e5d3-d27a-3d6c-a8d531caa37b 60505-2589 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20080922 ANDA ANDA077953 Apotex Corp RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 60505-2592_93655dd1-1a4c-6697-e899-5211039379ca 60505-2592 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA077982 Apotex Corp. ALENDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 60505-2593_93655dd1-1a4c-6697-e899-5211039379ca 60505-2593 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA077982 Apotex Corp. ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 60505-2594_93655dd1-1a4c-6697-e899-5211039379ca 60505-2594 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA077982 Apotex Corp. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 60505-2596_93655dd1-1a4c-6697-e899-5211039379ca 60505-2596 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA077982 Apotex Corp. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 60505-2597_9b2235c6-0453-bf8c-9ffd-0010ccee94f1 60505-2597 HUMAN PRESCRIPTION DRUG CABERGOLINE CABERGOLINE TABLET ORAL 20130308 ANDA ANDA201503 Apotex Corp. CABERGOLINE .5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 60505-2604_deb41b6c-93c2-0d01-c78a-9331b64e75ab 60505-2604 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA077884 Apotex Corp. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 60505-2605_deb41b6c-93c2-0d01-c78a-9331b64e75ab 60505-2605 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA077884 Apotex Corp. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 60505-2606_00d934fc-3959-1b5b-3471-33fde154e00a 60505-2606 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078165 Apotex Corp. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 60505-2607_00d934fc-3959-1b5b-3471-33fde154e00a 60505-2607 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078165 Apotex Corp. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 60505-2608_00d934fc-3959-1b5b-3471-33fde154e00a 60505-2608 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078165 Apotex Corp. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 60505-2609_00d934fc-3959-1b5b-3471-33fde154e00a 60505-2609 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078165 Apotex Corp. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 60505-2615_f4d07266-a42c-3db9-d189-252297d0c2d6 60505-2615 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20070913 ANDA ANDA065384 Apotex Corp CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 60505-2616_f4d07266-a42c-3db9-d189-252297d0c2d6 60505-2616 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20070913 ANDA ANDA065384 Apotex Corp CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 60505-2633_49c67999-d4cc-282b-b8af-e681aee5c330 60505-2633 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20071227 ANDA ANDA078317 Apotex Corp. CETIRIZINE HYDROCHLORIDE 10 mg/1 60505-2634_863b9832-c2b6-f0ce-6f93-fef40fa756a2 60505-2634 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20081112 ANDA ANDA078449 Apotex Corp ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60505-2635_863b9832-c2b6-f0ce-6f93-fef40fa756a2 60505-2635 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20081112 ANDA ANDA078449 Apotex Corp ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60505-2636_863b9832-c2b6-f0ce-6f93-fef40fa756a2 60505-2636 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20081112 ANDA ANDA078449 Apotex Corp ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60505-2637_863b9832-c2b6-f0ce-6f93-fef40fa756a2 60505-2637 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20081112 ANDA ANDA078449 Apotex Corp ALPRAZOLAM 3 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60505-2638_6a85395c-448a-071d-2c18-aef6319cf95a 60505-2638 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20080516 ANDA ANDA078389 Apotex Corp. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-2639_6a85395c-448a-071d-2c18-aef6319cf95a 60505-2639 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20080516 ANDA ANDA078389 Apotex Corp. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-2640_fb9b1500-f899-16a2-55f6-9c30938759a6 60505-2640 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20080129 ANDA ANDA040774 Apotex Corp. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-2641_fb9b1500-f899-16a2-55f6-9c30938759a6 60505-2641 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20080129 ANDA ANDA040774 Apotex Corp. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-2642_7cd5fd99-ea7f-432d-aa05-8c0ab4fffb75 60505-2642 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET ORAL 20090706 ANDA ANDA078917 Apotex Corp. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 60505-2644_e5807cf2-9c18-5218-0ede-d80112eea098 60505-2644 HUMAN PRESCRIPTION DRUG Tramadol hydrochloride and acetaminophen Tramadol hydrochloride and acetaminophen TABLET ORAL 20140830 ANDA ANDA078778 Apotex Corp. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 60505-2648_d283d59f-c580-e069-6426-420de5fb633c 60505-2648 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 ANDA ANDA078868 Apotex Corp. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 60505-2649_d283d59f-c580-e069-6426-420de5fb633c 60505-2649 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 ANDA ANDA078868 Apotex Corp. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 60505-2650_d283d59f-c580-e069-6426-420de5fb633c 60505-2650 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 ANDA ANDA078868 Apotex Corp. TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 60505-2651_fa28891f-11ab-179b-e2d1-f9afab3ac4f1 60505-2651 HUMAN PRESCRIPTION DRUG Eplerenone Eplerenone TABLET ORAL 20080730 ANDA ANDA078482 Apotex Corp EPLERENONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 60505-2652_fa28891f-11ab-179b-e2d1-f9afab3ac4f1 60505-2652 HUMAN PRESCRIPTION DRUG Eplerenone Eplerenone TABLET ORAL 20080730 ANDA ANDA078482 Apotex Corp EPLERENONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 60505-2653_3f95cf97-2c6e-b600-c438-abc541609e88 60505-2653 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071258 Apotex Corp TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 60505-2654_3f95cf97-2c6e-b600-c438-abc541609e88 60505-2654 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071196 Apotex Corp TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 60505-2655_3f95cf97-2c6e-b600-c438-abc541609e88 60505-2655 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071196 Apotex Corp TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 60505-2656_ff4ecb50-9714-6f6b-3059-3ae7de33f204 60505-2656 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20090921 ANDA ANDA071251 Apotex Corp. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-2657_ff4ecb50-9714-6f6b-3059-3ae7de33f204 60505-2657 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20090921 ANDA ANDA071251 Apotex Corp. HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-2658_52a67b3d-1a48-5258-9113-c64972d0cee5 60505-2658 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20081106 ANDA ANDA078578 APOTEX Corp AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 60505-2659_3f95cf97-2c6e-b600-c438-abc541609e88 60505-2659 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20090105 ANDA ANDA071196 Apotex Corp TRAZODONE HYDROCHLORIDE 300 mg/1 Serotonin Reuptake Inhibitor [EPC] 60505-2660_07ec7d47-fe3d-3207-6da5-b23c8dd670a5 60505-2660 HUMAN PRESCRIPTION DRUG Flecainide Acetate flecainide acetate TABLET ORAL 20090709 ANDA ANDA079164 Apotex Corp. FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] 60505-2661_07ec7d47-fe3d-3207-6da5-b23c8dd670a5 60505-2661 HUMAN PRESCRIPTION DRUG Flecainide Acetate flecainide acetate TABLET ORAL 20090709 ANDA ANDA079164 Apotex Corp. FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] 60505-2662_07ec7d47-fe3d-3207-6da5-b23c8dd670a5 60505-2662 HUMAN PRESCRIPTION DRUG Flecainide Acetate flecainide acetate TABLET ORAL 20090709 ANDA ANDA079164 Apotex Corp. FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] 60505-2663_0a9c5e7b-1db5-a708-78a1-f1bc7fc00834 60505-2663 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078625 Apotex Corp LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 60505-2664_0a9c5e7b-1db5-a708-78a1-f1bc7fc00834 60505-2664 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078625 Apotex Corp LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 60505-2665_0a9c5e7b-1db5-a708-78a1-f1bc7fc00834 60505-2665 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078625 Apotex Corp LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 60505-2671_7699e0c0-9dbc-12d5-207e-6c7fede52d3a 60505-2671 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Apotex Corp. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60505-2680_0a9c5e7b-1db5-a708-78a1-f1bc7fc00834 60505-2680 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078625 Apotex Corp LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 60505-2740_a542ca0c-8633-f5cb-9ff3-ee39fc3abc9f 60505-2740 HUMAN PRESCRIPTION DRUG Verapamil Verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121119 ANDA ANDA200878 Apotex Corp. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60505-2741_a542ca0c-8633-f5cb-9ff3-ee39fc3abc9f 60505-2741 HUMAN PRESCRIPTION DRUG Verapamil Verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121119 ANDA ANDA200878 Apotex Corp. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60505-2742_a542ca0c-8633-f5cb-9ff3-ee39fc3abc9f 60505-2742 HUMAN PRESCRIPTION DRUG Verapamil Verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121119 ANDA ANDA200878 Apotex Corp. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60505-2760_ef9d6bea-dc44-07ae-9d38-115ebee762cc 60505-2760 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077733 Apotex Corp TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-2761_ef9d6bea-dc44-07ae-9d38-115ebee762cc 60505-2761 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077733 Apotex Corp TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-2762_ef9d6bea-dc44-07ae-9d38-115ebee762cc 60505-2762 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077733 Apotex Corp TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-2763_ef9d6bea-dc44-07ae-9d38-115ebee762cc 60505-2763 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077733 Apotex Corp TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-2780_5ae0a445-55aa-2a65-0f93-0a9d2e520704 60505-2780 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA078777 Apotex Corp. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-2781_5ae0a445-55aa-2a65-0f93-0a9d2e520704 60505-2781 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA078777 Apotex Corp. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-2782_5ae0a445-55aa-2a65-0f93-0a9d2e520704 60505-2782 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA078777 Apotex Corp. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-2795_eb64eea6-c2ec-c183-3ebb-29d35b70c390 60505-2795 HUMAN PRESCRIPTION DRUG IBANDRONATE SODIUM IBANDRONATE SODIUM TABLET, FILM COATED ORAL 20120319 ANDA ANDA078948 Apotex Corp IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 60505-2805_ec92637d-8ed7-a795-4556-c069bb36e71f 60505-2805 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20120323 ANDA ANDA078986 Apotex Corp. CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 60505-2806_ec92637d-8ed7-a795-4556-c069bb36e71f 60505-2806 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20120323 ANDA ANDA078986 Apotex Corp. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 60505-2807_ec92637d-8ed7-a795-4556-c069bb36e71f 60505-2807 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20120323 ANDA ANDA078986 Apotex Corp. CARBAMAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 60505-2850_252ba55f-c24b-d4a3-27ae-ed0ebf29d7a3 60505-2850 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110718 ANDA ANDA079013 Apotex Corp. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60505-2865_069ad836-6c1c-91ae-3e47-2f2f0b444439 60505-2865 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED ORAL 20130329 ANDA ANDA079165 Apotex Corp. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 60505-2866_069ad836-6c1c-91ae-3e47-2f2f0b444439 60505-2866 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED ORAL 20130329 ANDA ANDA079165 Apotex Corp. ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 60505-2867_069ad836-6c1c-91ae-3e47-2f2f0b444439 60505-2867 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED ORAL 20130329 ANDA ANDA079165 Apotex Corp. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 60505-2868_069ad836-6c1c-91ae-3e47-2f2f0b444439 60505-2868 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED ORAL 20130329 ANDA ANDA079165 Apotex Corp. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 60505-2869_069ad836-6c1c-91ae-3e47-2f2f0b444439 60505-2869 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED ORAL 20130329 ANDA ANDA079165 Apotex Corp. ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 60505-2870_069ad836-6c1c-91ae-3e47-2f2f0b444439 60505-2870 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED ORAL 20130329 ANDA ANDA079165 Apotex Corp. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 60505-2871_069ad836-6c1c-91ae-3e47-2f2f0b444439 60505-2871 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED ORAL 20130329 ANDA ANDA079165 Apotex Corp. ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 60505-2875_175fc12a-823f-4a32-8108-e6121af0f275 60505-2875 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080620 ANDA ANDA079116 Apotex Corp. RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-2876_175fc12a-823f-4a32-8108-e6121af0f275 60505-2876 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080620 ANDA ANDA079116 Apotex Corp. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-2877_175fc12a-823f-4a32-8108-e6121af0f275 60505-2877 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080620 ANDA ANDA079116 Apotex Corp. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-2878_175fc12a-823f-4a32-8108-e6121af0f275 60505-2878 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080620 ANDA ANDA079116 Apotex Corp. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60505-2880_aa1e15d9-730b-089b-fd92-fe8d6f4abbc2 60505-2880 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20130715 ANDA ANDA200172 Apotex Corp. RANITIDINE HYDROCHLORIDE 150 mg/1 60505-2881_75f051d3-142c-9892-e6ed-832409de096f 60505-2881 HUMAN OTC DRUG Ranitidine Ranitidine hydrochloride TABLET, FILM COATED ORAL 20050124 ANDA ANDA075167 Apotex Corp. RANITIDINE HYDROCHLORIDE 75 mg/1 60505-2915_f00e51e7-57fe-42e5-0672-512097ce6a7a 60505-2915 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA090150 Apotex Corp. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-2916_f00e51e7-57fe-42e5-0672-512097ce6a7a 60505-2916 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA090150 Apotex Corp. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-2917_f00e51e7-57fe-42e5-0672-512097ce6a7a 60505-2917 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA090150 Apotex Corp. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-2965_37681df9-82c7-77bd-5197-3898e8a664e6 60505-2965 HUMAN PRESCRIPTION DRUG Mycophenolic Acid Mycophenolic Acid TABLET, DELAYED RELEASE ORAL 20120821 ANDA ANDA091558 Apotex Corp MYCOPHENOLATE SODIUM 180 mg/1 Antimetabolite Immunosuppressant [EPC] 60505-2966_37681df9-82c7-77bd-5197-3898e8a664e6 60505-2966 HUMAN PRESCRIPTION DRUG Mycophenolic Acid Mycophenolic Acid TABLET, DELAYED RELEASE ORAL 20140819 ANDA ANDA091558 Apotex Corp MYCOPHENOLATE SODIUM 360 mg/1 Antimetabolite Immunosuppressant [EPC] 60505-2967_00e70f0e-ee2b-2b68-83b3-bda00be98283 60505-2967 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET, COATED ORAL 20090504 ANDA ANDA090499 Apotex Corp MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 60505-2968_00e70f0e-ee2b-2b68-83b3-bda00be98283 60505-2968 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20090504 ANDA ANDA090419 Apotex Corp MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 60505-2985_90606112-256a-d8c4-ef28-e88950863031 60505-2985 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, FILM COATED ORAL 20120531 ANDA ANDA200654 Apotex Corp. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 60505-2995_7e4a3bc1-82a7-c910-c380-2e2404d2135f 60505-2995 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Apotex Corp. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-2996_7e4a3bc1-82a7-c910-c380-2e2404d2135f 60505-2996 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Apotex Corp. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-2997_7e4a3bc1-82a7-c910-c380-2e2404d2135f 60505-2997 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Apotex Corp. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-2998_7e4a3bc1-82a7-c910-c380-2e2404d2135f 60505-2998 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Apotex Corp. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-3096_80396f51-7e78-f6c2-5234-3191a294f9ce 60505-3096 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, FILM COATED ORAL 20140611 ANDA ANDA090877 Apotex Corp. RISEDRONATE SODIUM ANHYDROUS 75 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 60505-3097_80396f51-7e78-f6c2-5234-3191a294f9ce 60505-3097 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, FILM COATED ORAL 20140611 ANDA ANDA090877 Apotex Corp. RISEDRONATE SODIUM ANHYDROUS 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 60505-3110_a5e8111e-2e15-4f34-cdd5-225afc99c04a 60505-3110 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Apotex Corp. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 60505-3111_a5e8111e-2e15-4f34-cdd5-225afc99c04a 60505-3111 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Apotex Corp. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 60505-3112_a5e8111e-2e15-4f34-cdd5-225afc99c04a 60505-3112 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Apotex Corp. OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 60505-3113_a5e8111e-2e15-4f34-cdd5-225afc99c04a 60505-3113 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Apotex Corp. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 60505-3114_a5e8111e-2e15-4f34-cdd5-225afc99c04a 60505-3114 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Apotex Corp. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 60505-3120_21d432da-766a-155a-f3f0-eccb537a7586 60505-3120 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20130726 ANDA ANDA202252 Apotex Corp. FENOFIBRATE 43 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 60505-3121_21d432da-766a-155a-f3f0-eccb537a7586 60505-3121 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20130726 ANDA ANDA202252 Apotex Corp. FENOFIBRATE 130 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 60505-3130_fe59446a-488f-93ca-f9bf-6c43ab3a7276 60505-3130 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 60505-3131_fe59446a-488f-93ca-f9bf-6c43ab3a7276 60505-3131 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 60505-3132_fe59446a-488f-93ca-f9bf-6c43ab3a7276 60505-3132 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 60505-3133_fe59446a-488f-93ca-f9bf-6c43ab3a7276 60505-3133 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 60505-3134_fe59446a-488f-93ca-f9bf-6c43ab3a7276 60505-3134 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 60505-3135_fe59446a-488f-93ca-f9bf-6c43ab3a7276 60505-3135 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 60505-3136_fe59446a-488f-93ca-f9bf-6c43ab3a7276 60505-3136 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 60505-3137_fe59446a-488f-93ca-f9bf-6c43ab3a7276 60505-3137 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 60505-3138_fe59446a-488f-93ca-f9bf-6c43ab3a7276 60505-3138 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 60505-3139_fe59446a-488f-93ca-f9bf-6c43ab3a7276 60505-3139 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 60505-3140_a5e8111e-2e15-4f34-cdd5-225afc99c04a 60505-3140 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Apotex Corp. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 60505-3145_2d3a7982-39c4-f623-294c-3d629f16eadb 60505-3145 HUMAN PRESCRIPTION DRUG Cevimeline Hydrochloride cevimeline hydrochloride CAPSULE ORAL 20121008 ANDA ANDA091260 Apotex Corp. CEVIMELINE HYDROCHLORIDE 30 mg/1 Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 60505-3160_7a6e244e-e8bc-554f-3fb5-f923a20cc72d 60505-3160 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090790 Apotex Corp LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60505-3161_7a6e244e-e8bc-554f-3fb5-f923a20cc72d 60505-3161 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090790 Apotex Corp LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60505-3162_7a6e244e-e8bc-554f-3fb5-f923a20cc72d 60505-3162 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090790 Apotex Corp LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60505-3220_86dc9e23-c5a2-8361-4b5d-80b0d6109c98 60505-3220 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20130220 ANDA ANDA091072 Apotex Corp. RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 60505-3221_86dc9e23-c5a2-8361-4b5d-80b0d6109c98 60505-3221 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20130220 ANDA ANDA091072 Apotex Corp. RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 60505-3222_86dc9e23-c5a2-8361-4b5d-80b0d6109c98 60505-3222 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20130220 ANDA ANDA091072 Apotex Corp. RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 60505-3223_86dc9e23-c5a2-8361-4b5d-80b0d6109c98 60505-3223 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20130220 ANDA ANDA091072 Apotex Corp. RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 60505-3245_106f8caf-2c44-36a3-53ef-f7929499316c 60505-3245 HUMAN PRESCRIPTION DRUG FAMCICLOVIR FAMCICLOVIR TABLET, FILM COATED ORAL 20111220 ANDA ANDA091480 Apotex Corp. FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 60505-3246_106f8caf-2c44-36a3-53ef-f7929499316c 60505-3246 HUMAN PRESCRIPTION DRUG FAMCICLOVIR FAMCICLOVIR TABLET, FILM COATED ORAL 20111220 ANDA ANDA091480 Apotex Corp. FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 60505-3247_106f8caf-2c44-36a3-53ef-f7929499316c 60505-3247 HUMAN PRESCRIPTION DRUG FAMCICLOVIR FAMCICLOVIR TABLET, FILM COATED ORAL 20111220 ANDA ANDA091480 Apotex Corp. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 60505-3250_f0758d18-70f7-0681-0f67-b2a0dbb955f8 60505-3250 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20140103 ANDA ANDA202941 Apotex Corp. LAMIVUDINE 100 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 60505-3251_c4fb4148-5693-f27c-ff69-adc021f93091 60505-3251 HUMAN PRESCRIPTION DRUG LAMIVUDINE lamivudine TABLET, FILM COATED ORAL 20111202 ANDA ANDA091606 Apotex Corp. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 60505-3252_c4fb4148-5693-f27c-ff69-adc021f93091 60505-3252 HUMAN PRESCRIPTION DRUG LAMIVUDINE lamivudine TABLET, FILM COATED ORAL 20111202 ANDA ANDA091606 Apotex Corp. LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 60505-3255_5d4c6d2c-0b68-3c2c-ac42-1131070308bc 60505-3255 HUMAN PRESCRIPTION DRUG Letrozole Letrozole TABLET, FILM COATED ORAL 20120531 ANDA ANDA091303 Apotex Corp. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 60505-3275_cf4cacb9-b587-2fa1-e8fb-f03382b08bc8 60505-3275 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA091265 Apotex Corp. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 60505-3276_cf4cacb9-b587-2fa1-e8fb-f03382b08bc8 60505-3276 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA091265 Apotex Corp. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 60505-3277_cf4cacb9-b587-2fa1-e8fb-f03382b08bc8 60505-3277 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA091265 Apotex Corp. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 60505-3278_cf4cacb9-b587-2fa1-e8fb-f03382b08bc8 60505-3278 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA091265 Apotex Corp. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 60505-3280_f60b9b5f-f7d9-cb82-896f-0e91467344ee 60505-3280 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091261 Apotex Corp. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-3285_f02b47a7-bb71-9987-8d2c-49026f6956c7 60505-3285 HUMAN PRESCRIPTION DRUG RILUZOLE RILUZOLE TABLET, FILM COATED ORAL 20130618 ANDA ANDA091300 Apotex Corp RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] 60505-3404_a2ad6796-79e2-69a7-4d39-052bc821d757 60505-3404 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20121106 ANDA ANDA091379 Apotex Corp. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 60505-3409_bdb49a77-d769-248d-fdb3-90d38b2f0531 60505-3409 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130312 ANDA ANDA091524 Apotex Corp HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-3410_bdb49a77-d769-248d-fdb3-90d38b2f0531 60505-3410 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130312 ANDA ANDA091524 Apotex Corp HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-3411_bdb49a77-d769-248d-fdb3-90d38b2f0531 60505-3411 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130312 ANDA ANDA091524 Apotex Corp HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-3438_3b64b370-6c29-8d83-7647-22dd8ecb863f 60505-3438 HUMAN PRESCRIPTION DRUG Selegiline Hydrochloride Selegiline Hydrochloride TABLET ORAL 19970706 ANDA ANDA074871 Apotex Corp. SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] 60505-3454_3fbba8ec-742b-d899-b0b4-03223e4a918a 60505-3454 HUMAN PRESCRIPTION DRUG TROSPIUM CHLORIDE TROSPIUM CHLORIDE TABLET ORAL 20121015 ANDA ANDA091513 Apotex Corp. TROSPIUM CHLORIDE 20 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 60505-3517_f60b9b5f-f7d9-cb82-896f-0e91467344ee 60505-3517 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091261 Apotex Corp. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60505-3527_73fbd878-eca5-f707-511e-5afa2fac0b20 60505-3527 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate TABLET, FILM COATED ORAL 20120925 ANDA ANDA200164 Apotex Corp. TOLTERODINE TARTRATE 1 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 60505-3528_73fbd878-eca5-f707-511e-5afa2fac0b20 60505-3528 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate TABLET, FILM COATED ORAL 20120925 ANDA ANDA200164 Apotex Corp. TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 60505-3532_f283497c-525b-d6eb-bd01-f6ebd5b8f226 60505-3532 HUMAN PRESCRIPTION DRUG Clopidogrel clopidogrel bisulfate TABLET, FILM COATED ORAL 20140304 ANDA ANDA076274 Apotex Corp. CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 60505-3547_6fb95a13-3249-c5d5-5e95-b7dfcc9e81e8 60505-3547 HUMAN PRESCRIPTION DRUG IRBESARTAN IRBESARTAN TABLET, FILM COATED ORAL 20121016 ANDA ANDA200832 Apotex Corp. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60505-3548_6fb95a13-3249-c5d5-5e95-b7dfcc9e81e8 60505-3548 HUMAN PRESCRIPTION DRUG IRBESARTAN IRBESARTAN TABLET, FILM COATED ORAL 20121016 ANDA ANDA200832 Apotex Corp. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60505-3549_6fb95a13-3249-c5d5-5e95-b7dfcc9e81e8 60505-3549 HUMAN PRESCRIPTION DRUG IRBESARTAN IRBESARTAN TABLET, FILM COATED ORAL 20121016 ANDA ANDA200832 Apotex Corp. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60505-3562_29b0cb8d-e21a-5b11-0d7d-1750fc84eb17 60505-3562 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA201294 Apotex Corp MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 60505-3573_29b0cb8d-e21a-5b11-0d7d-1750fc84eb17 60505-3573 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA201508 Apotex Corp MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 60505-3574_29b0cb8d-e21a-5b11-0d7d-1750fc84eb17 60505-3574 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA201508 Apotex Corp MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 60505-3578_c3895624-6196-1b2c-1230-fbf8f03226d6 60505-3578 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100514 ANDA ANDA077928 Apotex Corp MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60505-3579_c3895624-6196-1b2c-1230-fbf8f03226d6 60505-3579 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100514 ANDA ANDA077928 Apotex Corp MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60505-3583_72fdf672-e58a-0cb6-53a1-c46ef18f1c45 60505-3583 HUMAN PRESCRIPTION DRUG Abacavir Sulfate Abacavir Sulfate TABLET, FILM COATED ORAL 20121217 ANDA ANDA201570 Apotex Corp ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 60505-3603_e6becbd0-cabe-825d-ba18-54852cab67a6 60505-3603 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20121016 ANDA ANDA201505 Apotex Corp. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-3604_e6becbd0-cabe-825d-ba18-54852cab67a6 60505-3604 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20121016 ANDA ANDA201505 Apotex Corp. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-3618_432f7675-1f8c-906d-ceb3-a15c9ccb460c 60505-3618 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil Candesartan cilexetil TABLET ORAL 20140113 ANDA ANDA202079 Apotex Corp CANDESARTAN CILEXETIL 4 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60505-3619_432f7675-1f8c-906d-ceb3-a15c9ccb460c 60505-3619 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil Candesartan Cilexetil TABLET ORAL 20140113 ANDA ANDA202079 Apotex Corp CANDESARTAN CILEXETIL 8 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60505-3620_432f7675-1f8c-906d-ceb3-a15c9ccb460c 60505-3620 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil Candesartan Cilexetil TABLET ORAL 20140113 ANDA ANDA202079 Apotex Corp CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60505-3621_432f7675-1f8c-906d-ceb3-a15c9ccb460c 60505-3621 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil Candesartan Cilexetil TABLET ORAL 20140113 ANDA ANDA202079 Apotex Corp CANDESARTAN CILEXETIL 32 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60505-3638_4e51f884-e586-b989-728a-6c67eeab53e4 60505-3638 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid TABLET ORAL 20140127 ANDA ANDA202286 Apotex Corp. TRANEXAMIC ACID 650 1/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 60505-3663_b06b2299-84a6-c7f8-7ec2-c89c3b359892 60505-3663 HUMAN PRESCRIPTION DRUG PAXIL paroxetine hydrochloride TABLET, FILM COATED ORAL 20110101 NDA NDA020031 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-3664_b06b2299-84a6-c7f8-7ec2-c89c3b359892 60505-3664 HUMAN PRESCRIPTION DRUG PAXIL paroxetine hydrochloride TABLET, FILM COATED ORAL 20110101 NDA NDA020031 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-3665_b06b2299-84a6-c7f8-7ec2-c89c3b359892 60505-3665 HUMAN PRESCRIPTION DRUG PAXIL paroxetine hydrochloride TABLET, FILM COATED ORAL 20110101 NDA NDA020031 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-3666_b06b2299-84a6-c7f8-7ec2-c89c3b359892 60505-3666 HUMAN PRESCRIPTION DRUG PAXIL paroxetine hydrochloride TABLET, FILM COATED ORAL 20110101 NDA NDA020031 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-3668_cf9d7915-97a7-dfc9-a11c-e941e09b1837 60505-3668 HUMAN PRESCRIPTION DRUG PAXIL CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110101 NDA NDA020936 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-3669_cf9d7915-97a7-dfc9-a11c-e941e09b1837 60505-3669 HUMAN PRESCRIPTION DRUG PAXIL CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110101 NDA NDA020936 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-3670_cf9d7915-97a7-dfc9-a11c-e941e09b1837 60505-3670 HUMAN PRESCRIPTION DRUG PAXIL CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110101 NDA NDA020936 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 37.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-3673_8ef51a3b-8d22-4171-acb2-0294b6a27bc3 60505-3673 HUMAN PRESCRIPTION DRUG PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100913 NDA NDA020936 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-3674_8ef51a3b-8d22-4171-acb2-0294b6a27bc3 60505-3674 HUMAN PRESCRIPTION DRUG PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100913 NDA NDA020936 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-3675_8ef51a3b-8d22-4171-acb2-0294b6a27bc3 60505-3675 HUMAN PRESCRIPTION DRUG PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100913 NDA NDA020936 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 37.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-3693_95f50fbe-3819-fe56-6cdf-41c28e7be011 60505-3693 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20130514 ANDA ANDA202078 Apotex Corp ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 60505-3694_95f50fbe-3819-fe56-6cdf-41c28e7be011 60505-3694 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20130514 ANDA ANDA202078 Apotex Corp ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 60505-3698_6edd692d-f695-3b93-1661-5046bf2636d4 60505-3698 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20121229 ANDA ANDA202244 Apotex Corp RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 60505-3699_6edd692d-f695-3b93-1661-5046bf2636d4 60505-3699 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20121229 ANDA ANDA202244 Apotex Corp RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 60505-3718_95f50fbe-3819-fe56-6cdf-41c28e7be011 60505-3718 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130514 ANDA ANDA202476 Apotex Corp ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 60505-3719_95f50fbe-3819-fe56-6cdf-41c28e7be011 60505-3719 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130514 ANDA ANDA202476 Apotex Corp ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 60505-3723_f80652f3-cc59-40cd-5073-bfc083934c8a 60505-3723 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA202477 Apotex Corp RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 60505-3724_f80652f3-cc59-40cd-5073-bfc083934c8a 60505-3724 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA202477 Apotex Corp RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 60505-3758_b0744b28-b68c-c6c2-21ac-bd0449735ec8 60505-3758 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil and Hydrochlorothiazide Candesartan Cilexetil and Hydrochlorothiazide TABLET ORAL 20121204 ANDA ANDA202884 Apotex Corp. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 16; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-3759_b0744b28-b68c-c6c2-21ac-bd0449735ec8 60505-3759 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil and Hydrochlorothiazide Candesartan Cilexetil and Hydrochlorothiazide TABLET ORAL 20121204 ANDA ANDA202884 Apotex Corp. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-3760_b0744b28-b68c-c6c2-21ac-bd0449735ec8 60505-3760 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil and Hydrochlorothiazide Candesartan Cilexetil and Hydrochlorothiazide TABLET ORAL 20130603 ANDA ANDA202884 Apotex Corp. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-3778_71686e67-0e75-4932-b6b1-71da444ef283 60505-3778 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 NDA AUTHORIZED GENERIC NDA020699 Apotex Corp. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-3779_71686e67-0e75-4932-b6b1-71da444ef283 60505-3779 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 NDA AUTHORIZED GENERIC NDA020699 Apotex Corp. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-3780_71686e67-0e75-4932-b6b1-71da444ef283 60505-3780 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 NDA AUTHORIZED GENERIC NDA020699 Apotex Corp. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60505-3788_4143ae49-f8ca-0482-2ee1-ccd86a3590a5 60505-3788 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET ORAL 20120522 ANDA ANDA203021 Apotex Corp NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 60505-3806_4702640b-5d3e-59e5-dd5e-da6155a6281a 60505-3806 HUMAN PRESCRIPTION DRUG valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA203026 Apotex Corp. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-3807_4702640b-5d3e-59e5-dd5e-da6155a6281a 60505-3807 HUMAN PRESCRIPTION DRUG valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA203026 Apotex Corp. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-3808_4702640b-5d3e-59e5-dd5e-da6155a6281a 60505-3808 HUMAN PRESCRIPTION DRUG valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA203026 Apotex Corp. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-3809_4702640b-5d3e-59e5-dd5e-da6155a6281a 60505-3809 HUMAN PRESCRIPTION DRUG valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA203026 Apotex Corp. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-3810_4702640b-5d3e-59e5-dd5e-da6155a6281a 60505-3810 HUMAN PRESCRIPTION DRUG valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA203026 Apotex Corp. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60505-3952_6858f7ae-8277-7dde-2f5a-1c426b942782 60505-3952 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 Apotex Corp OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 60505-3992_f283497c-525b-d6eb-bd01-f6ebd5b8f226 60505-3992 HUMAN PRESCRIPTION DRUG Clopidogrel clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA076274 Apotex Corp. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 60505-4058_6309c01e-9dac-2896-b90d-1b1837f3d3a7 60505-4058 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET, EXTENDED RELEASE ORAL 20140415 ANDA ANDA205258 Apotex Corp NEVIRAPINE 400 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 60505-5306_1a7055b7-8c7e-68e5-4010-5c4d3e5b49cb 60505-5306 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20070609 ANDA ANDA077309 Apotex Corp. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 60505-5307_1a7055b7-8c7e-68e5-4010-5c4d3e5b49cb 60505-5307 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20060313 ANDA ANDA077309 Apotex Corp. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 60505-6025_1e1581d7-d084-42ec-a3e7-541c5dbf0892 60505-6025 HUMAN PRESCRIPTION DRUG Cefoxitin CEFOXITIN INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080227 ANDA ANDA065313 Apotex Corporation CEFOXITIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-6026_1e1581d7-d084-42ec-a3e7-541c5dbf0892 60505-6026 HUMAN PRESCRIPTION DRUG Cefoxitin CEFOXITIN INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080227 ANDA ANDA065313 Apotex Corporation CEFOXITIN SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-6030_d6d30d0f-b3c7-40c3-a527-9b237ce38d2a 60505-6030 HUMAN PRESCRIPTION DRUG Cefepime CEFEPIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070618 ANDA ANDA065369 Apotex Corporation CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-6031_d6d30d0f-b3c7-40c3-a527-9b237ce38d2a 60505-6031 HUMAN PRESCRIPTION DRUG Cefepime CEFEPIME INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20070618 ANDA ANDA065369 Apotex Corporation CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-6076_04f83cbb-e4c0-e1fa-ccdc-90d6917f97e3 60505-6076 HUMAN PRESCRIPTION DRUG Azithromycin azithromycin for injection injection, powder, lyophilized, for solution INJECTION INTRAVENOUS 20100425 ANDA ANDA065501 APOTEX CORP. AZITHROMYCIN MONOHYDRATE 500 mg/10mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 60505-6078_f423f9fe-8f02-4ca9-b2a7-37ecc89e7f65 60505-6078 HUMAN PRESCRIPTION DRUG FONDAPARINUX SODIUM fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20110718 NDA NDA021345 Apotex Corp. FONDAPARINUX SODIUM 2.5 mg/.5mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 60505-6079_f423f9fe-8f02-4ca9-b2a7-37ecc89e7f65 60505-6079 HUMAN PRESCRIPTION DRUG FONDAPARINUX SODIUM fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20110718 NDA NDA021345 Apotex Corp. FONDAPARINUX SODIUM 5 mg/.4mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 60505-6080_f423f9fe-8f02-4ca9-b2a7-37ecc89e7f65 60505-6080 HUMAN PRESCRIPTION DRUG FONDAPARINUX SODIUM fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20110718 NDA NDA021345 Apotex Corp. FONDAPARINUX SODIUM 7.5 mg/.6mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 60505-6081_f423f9fe-8f02-4ca9-b2a7-37ecc89e7f65 60505-6081 HUMAN PRESCRIPTION DRUG FONDAPARINUX SODIUM fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20110718 NDA NDA021345 Apotex Corp. FONDAPARINUX SODIUM 10 mg/.8mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 60505-6087_6167e1ca-d283-4dbf-80a5-9bfe45df60b3 60505-6087 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050802 ANDA ANDA065231 Apotex Corp. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-6088_6167e1ca-d283-4dbf-80a5-9bfe45df60b3 60505-6088 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050802 ANDA ANDA065231 Apotex Corp. CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-6093_6d2fe6ec-eb91-49d3-893e-796f83656ac0 60505-6093 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120420 ANDA ANDA065226 Apotex Corp CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-6094_253af1f8-6a2f-4f81-bb9b-56dde756afe4 60505-6094 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120420 ANDA ANDA065247 Apotex Corp CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-6102_ac6a7877-d725-4613-9e41-dd7331c93243 60505-6102 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 Apotex Corporation CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-6103_f55a5377-bebd-4087-b131-dcee7562cdb2 60505-6103 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050802 ANDA ANDA065232 Apotex Corporation CEFTRIAXONE SODIUM 100 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-6104_ac6a7877-d725-4613-9e41-dd7331c93243 60505-6104 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 Apotex Corporation CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 60505-6110_4d511336-3f94-4694-8f8b-088cb3bdcda0 60505-6110 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130920 ANDA ANDA202930 Apotex Corp ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 60505-7001_2799dc9e-fbb6-d205-ae23-5ad3f91193f7 60505-7001 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 Apotex Corp. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60505-7002_2799dc9e-fbb6-d205-ae23-5ad3f91193f7 60505-7002 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 Apotex Corp. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60505-7003_2799dc9e-fbb6-d205-ae23-5ad3f91193f7 60505-7003 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 Apotex Corp. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60505-7004_2799dc9e-fbb6-d205-ae23-5ad3f91193f7 60505-7004 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 Apotex Corp. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60505-7006_cff62a95-1aef-37e6-233f-013c4083b1d3 60505-7006 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Apotex Corp. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60505-7007_cff62a95-1aef-37e6-233f-013c4083b1d3 60505-7007 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Apotex Corp. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60505-7008_cff62a95-1aef-37e6-233f-013c4083b1d3 60505-7008 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Apotex Corp. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60505-7009_cff62a95-1aef-37e6-233f-013c4083b1d3 60505-7009 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Apotex Corp. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60512-0001_507d1e18-5d55-463f-ae7d-1ab5b4c5f00b 60512-0001 HUMAN OTC DRUG PMS RELIEF CIMICIFUGA RACEMOSA, MERCURIUS CORROSIVUS, SABINA, HYDRASTIS CANADENSIS, SECALE CORNUTUM, AURUM METALLICUM, HYOSCYAMUS NIGER, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACTAEA CIMICIFUGA ROOT; CLAVICEPS PURPUREA SCLEROTIUM; GOLD; HYDRASTIS CANADENSIS WHOLE; HYOSCYAMUS NIGER WHOLE; JUNIPERUS SABINA LEAFY TWIG; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; NITRIC ACID 4; 3; 9; 4; 3; 8; 4; 9; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-0002_29759bb3-63e9-4554-8d7f-253c753be95d 60512-0002 HUMAN OTC DRUG ECZEMA RELIEF NATRUM MURIATICUM, AGARICUS MUSCARIUS, PETROLEUM, SEPIA, KALI ARSENICOSUM, ALUMINA PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALUMINUM OXIDE; AMANITA MUSCARIA WHOLE; KEROSENE; POTASSIUM ARSENITE ANHYDROUS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE 6; 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 60512-0004_d41a82b6-34a5-4bd3-a343-299c37eee30a 60512-0004 HUMAN OTC DRUG ALLERGY RELIEF ALLIUM CEPA, ARSENICUM ALBUM, NUX VOMICA, SABADILLA, STICTA PULMONARIA, CUPRUM METALLICUM, ARALIA RACEMOSA PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALLIUM CEPA WHOLE; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; COPPER; LOBARIA PULMONARIA; SCHOENOCAULON OFFICINALE SEED; STRYCHNOS NUX-VOMICA SEED 6; 6; 9; 9; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-0006_94d6ed7f-9a04-4f33-ab42-9735780aa2c4 60512-0006 HUMAN OTC DRUG NATURCOKSINUM FLU RELIEF ANAS BARBARIAE HEPATIS ET CORDIS EXTRACTUM PELLET ORAL 19940814 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/g 60512-0007_0653326e-43f6-4a4f-889a-218e05afe37d 60512-0007 HUMAN OTC DRUG ACNE RELIEF SAPONARIA, ECHINACEA ANGUSTIFOLIA, KALIUM BROMATUM, VIOLA TRICOLOR, SELENIUM METALLICUM, NUX VOMICA, THUJA OCCIDENTALIS, PULSATILLA, CALCAREA PICRATA, SULPHUR IODATUM, ANTIMONIUM TARTARICUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ANTIMONY POTASSIUM TARTRATE; CALCIUM PICRATE; ECHINACEA ANGUSTIFOLIA; POTASSIUM BROMIDE; PULSATILLA VULGARIS; SAPONARIA OFFICINALIS ROOT; SELENIUM; STRYCHNOS NUX-VOMICA SEED; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; VIOLA TRICOLOR 6; 6; 3; 6; 6; 3; 4; 6; 6; 6; 3 [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1 60512-0008_9af9beb9-620d-4311-bbbf-e343bc51b111 60512-0008 HUMAN OTC DRUG MENTAL ALERTNESS SUPPORT PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, GELSEMIUM SEMPERVIRENS, VALERIANA OFFICINALIS PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORIC ACID; PICRIC ACID; VALERIAN 6; 9; 9; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-0009_a6d78c2e-6e72-442b-b9fe-5e71f01526f0 60512-0009 HUMAN OTC DRUG ARTHRITIS RELIEF CAUSTICUM, COLCHICUM AUTUMNALE, BENZOICUM ACIDUM, APIS MELLIFICA, ARSENICUM ALBUM, ARNICA MONTANA, NATRUM CARBONICUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; BENZOIC ACID; CAUSTICUM; COLCHICUM AUTUMNALE BULB; SODIUM CARBONATE 6; 7; 8; 3; 6; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-0010_e3e990ad-e27d-4e8c-9f78-afbe7e912d10 60512-0010 HUMAN OTC DRUG FATIGUE RELIEF ALFALFA, PHOSPHORUS, AVENA SATIVA, SELENIUM METALLICUM, AGNUS CASTUS, PHOSPHORICUM ACIDUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALFALFA WHOLE; AVENA SATIVA LEAF; CHASTE TREE; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM 2; 2; 2; 9; 6; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-0011_ea0ee15b-7740-4062-953d-0c20ea275aa7 60512-0011 HUMAN OTC DRUG INSOMNIA RELIEF PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AVENA SATIVA FLOWERING TOP; CUPRIC ACETATE; HYOSCYAMUS NIGER WHOLE; PASSIFLORA INCARNATA TOP; VALERIAN 2; 9; 9; 2; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-0012_39689f2d-b39d-4a50-aa18-901755aad773 60512-0012 HUMAN OTC DRUG MENOPAUSE SUPPORT LACHESIS MUTUS, AMYL NITROSUM, BRYONIA ALBA, AURUM METALLICUM, SANGUINARIA CANADENSIS PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AMYL NITRITE; BRYONIA ALBA ROOT; GOLD; LACHESIS MUTA VENOM; SANGUINARIA CANADENSIS ROOT 9; 4; 9; 10; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-0013_350d6c85-acf4-4966-a84e-380f57dba362 60512-0013 HUMAN OTC DRUG COUGH AND COLD RELIEF DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; DROSERA ROTUNDIFOLIA; IPECAC; MERCURIUS SOLUBILIS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS 12; 4; 3; 6; 30; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-0014_7ebc8729-d8bc-4883-a173-f3f2629808d4 60512-0014 HUMAN OTC DRUG ANXIETY/STRESS RELIEF ASA FOETIDA, IGNATIA AMARA, VALERIANA OFFICINALIS, AVENA SATIVA, ARGENTUM NITRICUM PELLET ORAL 20131023 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ASAFETIDA; AVENA SATIVA FLOWERING TOP; SILVER NITRATE; STRYCHNOS IGNATII SEED; VALERIAN 3; 3; 9; 4; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-0015_08e7e98e-92e0-40df-9bbb-9b0f220ae589 60512-0015 HUMAN OTC DRUG SINUS RELIEF ALLIUM CEPA, EUPHRASIA OFFICINALIS, STICTA PULMONARIA, HYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, NUX VOMICA, HEPAR SULPHURIS CALCAREUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALLIUM CEPA WHOLE; CALCIUM SULFIDE; EUPHRASIA STRICTA; GOLDENSEAL; LOBARIA PULMONARIA; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG 9; 9; 9; 3; 9; 9; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-0016_e9bdcc75-13ac-4b1c-aa3e-f2a46ed289e8 60512-0016 HUMAN OTC DRUG WEIGHT CONTROL SUPPORT THYROIDINUM, RHAMNUS FRANGULA, FUCUS VESICULOSUS, KALI IODATUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. FRANGULA ALNUS BARK; FUCUS VESICULOSUS; POTASSIUM IODIDE; THYROID, OVINE 3; 2; 6; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-0017_faaa2fab-8954-442f-a199-6b1fa40fa0b2 60512-0017 HUMAN OTC DRUG CANDIDA YEAST RELIEF BAPTISIA TINCTORIA, BRYONIA ALBA, ECHINACEA ANGUSTIFOLIA, THUJA OCCIDENTALIS, VISCUM ALBUM, CANDIDA ALBICANS PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CANDIDA ALBICANS; ECHINACEA ANGUSTIFOLIA; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM WHOLE 4; 4; 14; 4; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-0018_fd08ecac-8c58-42b1-8022-49a198d271e7 60512-0018 HUMAN OTC DRUG HEADACHE/MIGRAINE RELIEF CYCLAMEN EUROPAEUM, ANTIMONIUM CRUDUM, ALUMINA, LYCOPODIUM CLAVATUM, ARGENTUM NITRICUM, DIGITALIS PURPUREA, MELILOTUS OFFICINALIS, GLONOINUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALUMINUM OXIDE; ANTIMONY TRISULFIDE; CYCLAMEN PURPURASCENS TUBER; DIGITALIS PURPUREA WHOLE; LYCOPODIUM CLAVATUM SPORE; MELILOTUS OFFICINALIS TOP; NITROGLYCERIN; SILVER NITRATE 9; 9; 4; 9; 5; 4; 6; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-0050_d4441c45-4d56-4c57-ac7a-4da7791c9150 60512-0050 HUMAN OTC DRUG CALENDULA PLUS CALENDULA OFFICINALIS, ECHINACEA, HYPERICUM PERFORATUM, PHYTOLACCA DECANDRA, CANTHARIS, SULPHUR CREAM TOPICAL 19970326 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; LYTTA VESICATORIA; PHYTOLACCA AMERICANA ROOT; SULFUR 1; 1; 3; 3; 3; 3 [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g 60512-1001_23bba047-914d-4d20-a1c5-66a54b2c8eed 60512-1001 HUMAN OTC DRUG ACONITUM NAPELLUS ACONITUM NAPELLUS PELLET ORAL 19951024 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ACONITUM NAPELLUS 3 [hp_X]/1 60512-1002_19e754b3-7293-49e5-a700-a10b2b22f311 60512-1002 HUMAN OTC DRUG ALLIUM CEPA ALLIUM CEPA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ONION 1 [hp_X]/1 60512-1003_00d2c848-1dcb-469d-9d31-a5ac9ca1a201 60512-1003 HUMAN OTC DRUG ANTIMONIUM CRUDUM ANTIMONIUM CRUDUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ANTIMONY TRISULFIDE 3 [hp_X]/1 60512-1004_38c308cc-916f-49d6-9fa1-8c5f8f6caeb7 60512-1004 HUMAN OTC DRUG ANTIMONIUM TARTARICUM ANTIMONIUM TARTARICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ANTIMONY POTASSIUM TARTRATE 3 [hp_X]/1 60512-1005_ded831cc-2edb-45cc-aaf6-60d6223a614d 60512-1005 HUMAN OTC DRUG ARNICA MONTANA ARNICA MONTANA PELLET ORAL 19961011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA 3 [hp_X]/1 60512-1006_69d77078-dcce-44c5-8616-9df1c0a1a7b5 60512-1006 HUMAN OTC DRUG BELLADONNA BELLADONNA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ATROPA BELLADONNA 3 [hp_X]/1 60512-1007_82538f88-1e66-4df2-8ddc-377a0759248a 60512-1007 HUMAN OTC DRUG BRYONIA ALBA BRYONIA ALBA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC BRYONIA ALBA ROOT 3 [hp_X]/1 60512-1008_da89e93b-5dab-4717-a8ba-88f9b3a6fb8a 60512-1008 HUMAN OTC DRUG CALCAREA CARBONICA CALCAREA CARBONICA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. OYSTER SHELL CALCIUM CARBONATE, CRUDE 8 [hp_X]/1 60512-1009_0f960e66-2872-42f6-b081-c78664c81a87 60512-1009 HUMAN OTC DRUG CALCAREA PHOSPHORICA CALCAREA PHOSPHORICA PELLET ORAL 19951221 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC TRIBASIC CALCIUM PHOSPHATE 1 [hp_X]/1 60512-1010_2bf2a090-9000-46d3-b823-8a6fc69f6879 60512-1010 HUMAN OTC DRUG CALCAREA SULPHURICA CALCAREA SULPHURICA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CALCIUM SULFATE 6 [hp_X]/1 60512-1011_bbc42228-172a-4ac4-abee-d5d1737b993f 60512-1011 HUMAN OTC DRUG CARBO VEGETABILIS CARBO VEGETABILIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ACTIVATED CHARCOAL 1 [hp_X]/1 60512-1012_afed485f-30e7-4077-9543-3d245e090a7a 60512-1012 HUMAN OTC DRUG CAULOPHYLLUM THALICTROIDES CAULOPHYLLUM THALICTROIDES PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CAULOPHYLLUM THALICTROIDES ROOT 3 [hp_X]/1 60512-1013_d1cf6c38-1cae-4611-93be-02c412f48789 60512-1013 HUMAN OTC DRUG CHAMOMILLA CHAMOMILLA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC MATRICARIA RECUTITA 1 [hp_X]/1 60512-1014_bb7ae816-f833-4c62-88a5-86b39b349299 60512-1014 HUMAN OTC DRUG COLOCYNTHIS COLOCYNTHIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CITRULLUS COLOCYNTHIS FRUIT PULP 3 [hp_X]/1 60512-1015_7baaa926-234f-488a-983e-e11c8758d6b8 60512-1015 HUMAN OTC DRUG DROSERA ROTUNDIFOLIA DROSERA ROTUNDIFOLIA PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. DROSERA ROTUNDIFOLIA 1 [hp_X]/1 60512-1016_5cd9cd5e-f893-446d-abec-db99415bf4bf 60512-1016 HUMAN OTC DRUG DULCAMARA DULCAMARA PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SOLANUM DULCAMARA TOP 2 [hp_X]/1 60512-1017_aeb4b3a7-164a-4862-83dd-be2aa0d067c0 60512-1017 HUMAN OTC DRUG EUPATORIUM PERFOLIATUM EUPATORIUM PERFOLIATUM PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. EUPATORIUM PERFOLIATUM FLOWERING TOP 1 [hp_X]/1 60512-1018_acb70833-8e89-4948-b3e2-9612c061435d 60512-1018 HUMAN OTC DRUG EUPHRASIA OFFICINALIS EUPHRASIA OFFICINALIS PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. EUPHRASIA STRICTA 1 [hp_X]/1 60512-1019_1189a602-8c41-468a-8592-21886773fc45 60512-1019 HUMAN OTC DRUG FERRUM PHOSPHORICUM FERRUM PHOSPHORICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC FERROSOFERRIC PHOSPHATE 1 [hp_X]/1 60512-1020_b72e0200-e739-4552-9188-976bced2a0dc 60512-1020 HUMAN OTC DRUG GELSEMIUM SEMPERVIRENS GELSEMIUM SEMPERVIRENS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC GELSEMIUM SEMPERVIRENS ROOT 3 [hp_X]/1 60512-1021_cfec8084-1717-44d1-a2ed-4db9fddd4aa7 60512-1021 HUMAN OTC DRUG HAMAMELIS VIRGINIANA HAMAMELIS VIRGINIANA PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X]/1 60512-1022_a2505ba9-79d5-45ca-8f4a-ff4d952f4924 60512-1022 HUMAN OTC DRUG HEPAR SULPHURIS CALCAREUM HEPAR SULPHURIS CALCAREUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM SULFIDE 1 [hp_X]/1 60512-1023_6b6918de-6065-4927-8eaf-904410cb9426 60512-1023 HUMAN OTC DRUG HYPERICUM PERFORATUM HYPERICUM PERFORATUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC HYPERICUM PERFORATUM 3 [hp_X]/1 60512-1024_dbed9a33-71d8-437a-81d2-4df1e7e76d73 60512-1024 HUMAN OTC DRUG IGNATIA AMARA IGNATIA AMARA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC STRYCHNOS IGNATII SEED 3 [hp_X]/1 60512-1025_344e7e2f-9c20-4002-aa19-14ad07d6f5df 60512-1025 HUMAN OTC DRUG IPECACUANHA IPECACUANHA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC IPECAC 3 [hp_X]/1 60512-1030_ed84c011-d149-4e7a-91d2-595a66d0797d 60512-1030 HUMAN OTC DRUG LYCOPODIUM CLAVATUM LYCOPODIUM CLAVATUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC LYCOPODIUM CLAVATUM SPORE 1 [hp_X]/1 60512-1031_59e5feea-a351-48ca-8ba6-be8562eb722f 60512-1031 HUMAN OTC DRUG MERCURIUS VIVUS MERCURIUS VIVUS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC MERCURY 6 [hp_X]/1 60512-1032_715a9af0-5588-4cb8-aa49-9f7edbfdf026 60512-1032 HUMAN OTC DRUG NATRUM MURIATICUM NATRUM MURIATICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SODIUM CHLORIDE 1 [hp_X]/1 60512-1033_0d92dca3-7def-4d98-89f5-ee9995acca69 60512-1033 HUMAN OTC DRUG NATRUM PHOSPHORICUM NATRUM PHOSPHORICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SODIUM PHOSPHATE, DIBASIC 1 [hp_X]/1 60512-1034_70be8665-a7ba-498d-b7a8-355eac13109a 60512-1034 HUMAN OTC DRUG NATRUM SULPHURICUM NATRUM SULPHURICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SODIUM SULFATE 3 [hp_X]/1 60512-1035_bf3e089d-49f7-40de-9784-fd934554678d 60512-1035 HUMAN OTC DRUG NUX VOMICA NUX VOMICA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC STRYCHNOS NUX-VOMICA SEED 3 [hp_X]/1 60512-1036_9ba663c8-3830-49dd-8cd9-4de2d30983a8 60512-1036 HUMAN OTC DRUG PHOSPHORUS PHOSPHORUS PELLET ORAL 19951015 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC PHOSPHORUS 4 [hp_X]/1 60512-1038_5ecb5ce1-ed50-4d14-882c-6f05310a1637 60512-1038 HUMAN OTC DRUG PODOPHYLLUM PELTATUM PODOPHYLLUM PELTATUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. PODOPHYLLUM PELTATUM ROOT 3 [hp_X]/1 60512-1039_88ca8946-c398-4fa4-8ce9-59f69ad32a22 60512-1039 HUMAN OTC DRUG PULSATILLA PULSATILLA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. PULSATILLA VULGARIS 1 [hp_X]/1 60512-1040_0eb3bb86-39af-4dce-bb20-87da1168a281 60512-1040 HUMAN OTC DRUG RHUS TOXICODENDRON RHUS TOXICODENDRON PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC TOXICODENDRON PUBESCENS LEAF 3 [hp_X]/1 60512-1041_60bb4223-c894-4dbd-8b16-49b2424893b7 60512-1041 HUMAN OTC DRUG RUTA GRAVEOLENS RUTA GRAVEOLENS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]/1 60512-1043_60678b2c-eb4e-4ae1-b028-00d0a22ebc98 60512-1043 HUMAN OTC DRUG SEPIA SEPIA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SEPIA OFFICINALIS JUICE 1 [hp_X]/1 60512-1044_0545154c-3f72-4a6c-ac16-168c210773fb 60512-1044 HUMAN OTC DRUG SILICEA SILICEA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SILICON DIOXIDE 2 [hp_X]/1 60512-1045_37786a64-82fd-482f-85ed-e25bc50b68e1 60512-1045 HUMAN OTC DRUG SPONGIA TOSTA SPONGIA TOSTA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SPONGIA OFFICINALIS SKELETON, ROASTED 1 [hp_X]/1 60512-1047_8c12e5a9-ceec-457b-a30c-690b132bc11f 60512-1047 HUMAN OTC DRUG SULPHUR SULPHUR PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SULFUR 1 [hp_X]/1 60512-1049_6be4d47a-5ec6-4027-98d5-e39fb2e8d555 60512-1049 HUMAN OTC DRUG THUJA OCCIDENTALIS THUJA OCCIDENTALIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC THUJA OCCIDENTALIS LEAFY TWIG 1 [hp_X]/1 60512-1052_d1b3eb33-24dc-46f0-8490-7ebb19e6f844 60512-1052 HUMAN OTC DRUG ARSENICUM ALBUM ARSENICUM ALBUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARSENIC TRIOXIDE 6 [hp_X]/1 60512-2001_41ea57f9-f5b8-45f1-ab11-e914fbc8f8be 60512-2001 HUMAN OTC DRUG HEADACHE/MIGRAINE RELIEF CYCLAMEN EUROPAEUM, ANTIMONIUM CRUDUM, ALUMINA, LYCOPODIUM CLAVATUM, GLONOINUM, ARGENTUM NITRICUM, DIGITALIS PURPUREA, MELILOTUS OFFICINALIS LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALUMINUM OXIDE; ANTIMONY TRISULFIDE; CYCLAMEN PURPURASCENS TUBER; DIGITALIS PURPUREA WHOLE; LYCOPODIUM CLAVATUM SPORE; MELILOTUS OFFICINALIS TOP; NITROGLYCERIN; SILVER NITRATE 9; 9; 4; 9; 5; 4; 6; 9 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 60512-2002_41e3f5fe-3b70-4176-8a84-edc5b4d95c15 60512-2002 HUMAN OTC DRUG ALLERGY RELIEF ALLIUM CEPA, ARSENICUM ALBUM, NUX VOMICA, SABADILLA, STICTA PULMONARIA, CUPRUM METALLICUM, ARALIA RACEMOSA LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALLIUM CEPA WHOLE; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; COPPER; LOBARIA PULMONARIA; SCHOENOCAULON OFFICINALE SEED; STRYCHNOS NUX-VOMICA SEED 6; 6; 9; 9; 6; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 60512-2003_8d5300bb-ba7c-4c50-ba98-b23bd08b4dab 60512-2003 HUMAN OTC DRUG ANXIETY/STRESS ASA FOETIDA,IGNATIA AMARA,VALERIANA OFFICINALIS,AVENA SATIVA,ARGENTUM NITRICUM PELLET ORAL 20130523 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ASAFETIDA; AVENA SATIVA FLOWERING TOP; SILVER NITRATE; STRYCHNOS IGNATII SEED; VALERIAN 3; 3; 9; 4; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-2004_a71373d9-242b-47ab-9914-5dc8adee5144 60512-2004 HUMAN OTC DRUG CONSTIPATION RELIEF CROTON TIGLIUM, ALUMINA, ARGENTUM NITRICUM, PODOPHYLLUM PELTATUM, MAGNESIA CARBONICA LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALUMINUM OXIDE; CROTON TIGLIUM SEED; MAGNESIUM CARBONATE HYDROXIDE; PODOPHYLLUM PELTATUM ROOT; SILVER NITRATE 9; 9; 9; 9; 9 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 60512-2005_3a8b630e-3b64-4750-9b91-67b08d7b97e9 60512-2005 HUMAN OTC DRUG COUGH AND COLD RELIEF DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; DROSERA ROTUNDIFOLIA; IPECAC; MERCURIUS SOLUBILIS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS 9; 9; 9; 9; 9; 9; 9 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 60512-2006_64d81daf-7877-4f2a-9be5-7a9529368f81 60512-2006 HUMAN OTC DRUG FATIGUE RELIEF ALFALFA, PHOSPHORUS, AVENA SATIVA, SELENIUM METALLICUM, AGNUS CASTUS, PHOSPHORICUM ACIDUM LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALFALFA WHOLE; AVENA SATIVA LEAF; CHASTE TREE; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM 2; 2; 2; 9; 6; 9 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 60512-2007_6a3399f7-681c-4566-9e43-bc226676938f 60512-2007 HUMAN OTC DRUG INDIGESTION/GAS RELIEF NUX VOMICA, BRYONIA, IPECACUANHA, SULPHUR, ARSENICUM ALBUM, PULSATILLA, ROBINIA PSEUDOACACIA LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; IPECAC; PULSATILLA VULGARIS; ROBINIA PSEUDOACACIA BARK; STRYCHNOS NUX-VOMICA SEED; SULFUR 9; 9; 9; 9; 9; 9; 9 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 60512-2008_23a1b9b2-e0a0-48b6-ae4e-e42aa659d4ad 60512-2008 HUMAN OTC DRUG INSOMNIA RELIEF PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AVENA SATIVA FLOWERING TOP; CUPRIC ACETATE; HYOSCYAMUS NIGER WHOLE; PASSIFLORA INCARNATA TOP; VALERIAN 2; 9; 9; 2; 2 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 60512-2011_aea287d8-3016-4962-a633-5007d9c67071 60512-2011 HUMAN OTC DRUG ANXIETY/STRESS RELIEF ASA FOETIDA, IGNATIA AMARA, VALERIANA OFFICINALIS, AVENA SATIVA, ARGENTUM NITRICUM LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ASAFETIDA; AVENA SATIVA FLOWERING TOP; SILVER NITRATE; STRYCHNOS IGNATII SEED; VALERIAN 3; 3; 9; 4; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 60512-2012_adcdc496-ea0e-4d48-aaf8-7148fdb19de0 60512-2012 HUMAN OTC DRUG WEIGHT CONTROL SUPPORT THYROIDINUM, RHAMNUS FRANGULA, FUCUS VESICULOSUS, KALI IODATUM LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. FRANGULA ALNUS BARK; FUCUS VESICULOSUS; POTASSIUM IODIDE; THYROID, OVINE 3; 2; 6; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-2015_b73ab7f9-7233-40a7-9475-a4d993e82805 60512-2015 HUMAN OTC DRUG SMOKING WITHDRAWAL SUPPORT TABACUM, STAPHYSAGRIA, THUJA OCCIDENTALIS, LOBELIA INFLATA, MAGNESIA PHOSPHORICA LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. DELPHINIUM STAPHISAGRIA SEED; LOBELIA INFLATA; MAGNESIUM PHOSPHATE, DIBASIC; THUJA OCCIDENTALIS LEAFY TWIG; TOBACCO LEAF 5; 5; 9; 3; 15 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 60512-2016_09b3e423-0cc7-4b4a-ac22-9ee8a977d3a9 60512-2016 HUMAN OTC DRUG CAFFEINE WITHDRAWAL SUPPORT COFFEA TOSTA, STAPHYSAGRIA, GELSEMIUM SEMPERVIRENS, THUJA OCCIDENTALIS LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. COFFEA ARABICA SEED, ROASTED; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; THUJA OCCIDENTALIS LEAFY TWIG 3; 5; 5; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 60512-2020_c0535023-d30d-46a4-bc3a-543234984dce 60512-2020 HUMAN OTC DRUG EARACHE RELIEF FERRUM PHOSPHORICUM, CAPSICUM ANNUUM, THUJA OCCIDENTALIS, SILICEA, MERCURIUS VIVUS, KALI PHOSPHORICUM, PYROGENIUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CAPSICUM ANNUUM WHOLE; FERRUM PHOSPHORICUM; MERCURY; POTASSIUM PHOSPHATE, DIBASIC; RANCID BEEF; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 5; 8; 8; 6; 12; 8; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6001_829accd1-2b87-4c65-8aca-3b1742105c3b 60512-6001 HUMAN OTC DRUG ASTHMA RESPIRATORY CARE REAL RELIEF ERIODICTYON CALIFORNICUM, IPECACUANHA, LOBELIA INFLATA, BELLADONNA, SOLIDAGO VIRGAUREA, SAMBUCUS NIGRA, CRATAEGUS TABLET, CHEWABLE ORAL 20120725 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ATROPA BELLADONNA; ERIODICTYON CALIFORNICUM LEAF; HAWTHORN LEAF WITH FLOWER; IPECAC; LOBELIA INFLATA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6002_8cb329ea-0f3a-49be-bcce-40ca44a7c5a6 60512-6002 HUMAN OTC DRUG ASTHMA RESPIRATORY CARE NIGHTTIME REAL RELIEF ERIODICTYON CALIFORNICUM, IPECACUANHA, LOBELIA INFLATA, CHAMOMILLA, BELLADONNA, COFFEA CRUDA, SOLIDAGO VIRGAUREA, SAMBUCUS NIGRA, CRATAEGUS TABLET, CHEWABLE ORAL 20120711 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARABICA COFFEE BEAN; ATROPA BELLADONNA; ERIODICTYON CALIFORNICUM LEAF; HAWTHORN LEAF WITH FLOWER; IPECAC; LOBELIA INFLATA; MATRICARIA RECUTITA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP 8; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6005_7ed09afb-c5d4-4dfe-bb5b-10a6d7d45bdb 60512-6005 HUMAN OTC DRUG GAS AND BLOATING REAL RELIEF COLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSA TABLET, CHEWABLE ORAL 20120725 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6006_49f20d50-bb80-4bb5-a916-647b029862d0 60512-6006 HUMAN OTC DRUG NATURCOKSINUM FLU RELIEF DAYTIME REAL RELIEF ANAS BARBARIAE HEPATIS ET CORDIS EXTRACTUM TABLET, CHEWABLE ORAL 20120710 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/1 60512-6007_62b5a401-e18e-45a4-8d7e-dd3c0570f206 60512-6007 HUMAN OTC DRUG NATURCOKSINUM FLU RELIEF NIGHTTIME REAL RELIEF ANAS BARBARIAE HEPATIS ET CORDIS EXTRACTUM,CHAMOMILLA,COFFEA CRUDA TABLET, CHEWABLE ORAL 20120710 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARABICA COFFEE BEAN; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; MATRICARIA RECUTITA 4; 200; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1 60512-6009_9e770f5d-cbc0-4eb9-8093-cbf96900693a 60512-6009 HUMAN OTC DRUG ECZEMA REAL RELIEF FUMARIA OFFICINALIS, NATRUM MURIATICUM, AGARICUS MUSCARIUS, PETROLEUM, SEPIA, KALI ARSENICOSUM, ALUMINA TABLET, CHEWABLE ORAL 20120725 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALUMINUM OXIDE; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; FUMARIA OFFICINALIS FLOWERING TOP; KEROSENE; POTASSIUM ARSENITE ANHYDROUS; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE 6; 6; 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 60512-6010_7a89dc56-e0f8-474c-8db5-4c3b37464df5 60512-6010 HUMAN OTC DRUG PSORIASIS REAL RELIEF SULPHUR, ARSENICUM ALBUM, ALUMEN, MAGNESIA SULPHURICUM, NATRUM SULPHURICUM TABLET, CHEWABLE ORAL 20120711 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARSENIC TRIOXIDE; MAGNESIUM SULFATE HEPTAHYDRATE; POTASSIUM ALUM; SODIUM SULFATE; SULFUR 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6011_bbde7bf1-d690-469c-aa87-488dcc927071 60512-6011 HUMAN OTC DRUG MALE ERECTILE ENHANCER REAL RELIEF DAMIANA, PHOSPHORICUM ACIDUM, ARALIA QUINQUEFOLIA, SELENIUM METALLICUM, YOHIMBINUM TABLET, CHEWABLE ORAL 20120725 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC AMERICAN GINSENG; PHOSPHORIC ACID; SELENIUM; TURNERA DIFFUSA LEAFY TWIG; YOHIMBINE 1; 3; 8; 3; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 60512-6012_aaae5100-1d12-4faa-ab32-6a9122367810 60512-6012 HUMAN OTC DRUG FEMALE LIBIDO REAL RELIEF AGNUS CASTUS, VALERIANA, AMBRA GRISEA, DAMIANA, SELENIUM, LYCOPODIUM TABLET, CHEWABLE ORAL 20120725 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC AMBERGRIS; CHASTE TREE; LYCOPODIUM CLAVATUM SPORE; SELENIUM; TURNERA DIFFUSA LEAFY TWIG; VALERIAN 6; 4; 5; 5; 4; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6013_600dedde-85ab-4364-99ca-037aab9c960f 60512-6013 HUMAN OTC DRUG HEMORRHOIDS WITHOUT COMPLICATIONS REAL RELIEF PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA TABLET, CHEWABLE ORAL 20120711 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ALOE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; PAEONIA OFFICINALIS ROOT; PEUMUS BOLDUS LEAF; SULFUR; TEUCRIUM MARUM; VERBASCUM THAPSUS 8; 8; 4; 4; 8; 4; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6015_6b43f8e8-80da-47a9-80ea-cc70f683028f 60512-6015 HUMAN OTC DRUG FIBROMYALGIA REAL RELIEF CALCAREA PHOSPHORICA, IGNATIA AMARA, CAUSTICUM, RHUS TOXICODENDRON, MAGNESIA PHOSPHORICA, BRYONIA, ARNICA MONTANA TABLET, CHEWABLE ORAL 20120725 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS IGNATII SEED; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE 9; 7; 7; 7; 9; 7; 7 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 60512-6018_d791f9a2-d862-4f8f-873e-6e6fe8f679b0 60512-6018 HUMAN OTC DRUG DIARRHEA REAL RELIEF CINCHONA OFFICINALIS, BRYONIA, CHAMOMILLA, COLOCYNTHIS, IPECACUANHA, BELLADONNA TABLET, CHEWABLE ORAL 20121121 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ATROPA BELLADONNA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; MATRICARIA RECUTITA 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6020_50bd9c5e-5274-4e64-b17e-006621e978af 60512-6020 HUMAN OTC DRUG CANDIDA YEAST REAL RELIEF BAPTISIA TINCTORIA, BRYONIA, ECHINACEA ANGUSTIFOLIA, THUJA OCCIDENTALIS, VISCUM ALBUM TABLET, CHEWABLE ORAL 20121214 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6021_c44cc151-29b2-4666-887c-1301ba68348b 60512-6021 HUMAN OTC DRUG ARSENICUM METALLICUM ARSENICUM METALLICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARSENIC 8 [hp_X]/1 60512-6025_69bc0114-19d9-4a4f-aee3-fafd1799f8c7 60512-6025 HUMAN OTC DRUG ARNICA PLUS MUSCLE AND JOINT PAIN REAL RELIEF ARNICA, HYPERICUM PERFORATUM TABLET, CHEWABLE ORAL 20121121 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA; HYPERICUM PERFORATUM 6; 6 [hp_X]/1; [hp_X]/1 60512-6026_3205c0d2-b044-4859-a90c-4cf1026170a4 60512-6026 HUMAN OTC DRUG LEG CRAMPS REAL RELIEF MAGNESIA MURIATICA, MAGNESIA PHOSPHORICA, PLUMBUM ACETICUM, KALI PHOSPHORICUM, AMBRA GRISEA TABLET, CHEWABLE ORAL 20121121 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC AMBERGRIS; LEAD; MAGNESIUM CHLORIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM PHOSPHATE, DIBASIC 8; 8; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6030_1ea40849-40eb-4be7-b343-52f1fd5dc57c 60512-6030 HUMAN OTC DRUG ALLERGY REAL RELIEF ALLIUM CEPA, ARSENICUM ALBUM, NUX VOMICA, EUPHRASIA OFFICINALIS, SABADILLA, STICTA PULMONARIA, ARALIA RACEMOSA, CUPRUM METALLICUM TABLET, CHEWABLE ORAL 20121025 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; COPPER; EUPHRASIA STRICTA; LOBARIA PULMONARIA; ONION; SCHOENOCAULON OFFICINALE SEED; STRYCHNOS NUX-VOMICA SEED 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6031_cbb0883f-f17b-408d-a847-8fd45ab55bb4 60512-6031 HUMAN OTC DRUG HEADACHE AND MIGRAINE REAL RELIEF CYCLAMEN EUROPAEUM, ANTIMONIUM CRUDUM, ALUMINA, LYCOPODIUM CLAVATUM, ALUMINA, LYCOPODIUM CLAVATUM, ARGENTUM NITRICUM, DIGITALIS PURPUREA, MELILOTUS OFFICINALIS, GLONOINUM TABLET, CHEWABLE ORAL 20121025 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ALUMINUM OXIDE; ANTIMONY TRISULFIDE; CYCLAMEN PURPURASCENS TUBER; DIGITALIS; LYCOPODIUM CLAVATUM SPORE; MELILOTUS OFFICINALIS TOP; NITROGLYCERIN; SILVER NITRATE 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6032_59e5548e-a0dd-4cbc-92bf-718665cc26db 60512-6032 HUMAN OTC DRUG TINNITUS REAL RELIEF KALI BROMATUM, CINCHONA OFFICINALIS, SULPHUR, DULCAMARA, HYDRASTIS CANADENSIS, ARNICA MONTANA, BRYONIA CAUSTICUM TABLET, CHEWABLE ORAL 20121025 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; GOLDENSEAL; POTASSIUM BROMIDE; SOLANUM DULCAMARA TOP; SULFUR 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6033_19aa8211-d411-442a-a709-4155bb3c6725 60512-6033 HUMAN OTC DRUG HEMORRHOIDS REAL RELIEF AESCULUS HIPPOCASTANUM, HAMAMELIS VIRGINIANA, PAEONIA OFFICINALIS, COLLINSONIA CANADENSIS, TEUCRIEUM MARUM, VERBASCUM THAPSUS, BOLDO, SULPHUR, ALOE SOCOTRINA TABLET, CHEWABLE ORAL 20121025 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ALOE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; PAEONIA OFFICINALIS ROOT; PEUMUS BOLDUS LEAF; SULFUR; TEUCRIUM MARUM; VERBASCUM THAPSUS 8; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6036_80203b5e-6a1c-43fa-a3d4-1a1b561e9a8b 60512-6036 HUMAN OTC DRUG ARTHRITIS PAIN REAL RELIEF CAUSTICUM, COLCHICUM AUTUMNAL, BENZOICUM ACIDUM, APIS MELLIFICA, ARNICA MONTANA, NATRUM CARBONICUM TABLET, CHEWABLE ORAL 20121025 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. APIS MELLIFERA; ARNICA MONTANA; BENZOIC ACID; CAUSTICUM; COLCHICUM AUTUMNALE BULB; SODIUM CARBONATE 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6037_d6010783-9f0b-4afb-a561-e9af3619cfa1 60512-6037 HUMAN OTC DRUG INDIGESTION REAL RELIEF LYCOPODIUM CLAVATUM, CARDUUS MARIANUS, CHELIDONIUM MAJUS, BOLDO, NUX VOMICA TABLET, CHEWABLE ORAL 20120711 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; PEUMUS BOLDUS LEAF; SILYBUM MARIANUM SEED; STRYCHNOS NUX-VOMICA SEED 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6038_46b1f8f0-8e08-4461-b48e-4af84ea2bdaf 60512-6038 HUMAN OTC DRUG SEVERE HEMORRHOIDS REAL RELIEF PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA TABLET, CHEWABLE ORAL 20120725 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC APIS MELLIFERA; GRAPHITE; HORSE CHESTNUT; KRAMERIA LAPPACEA ROOT; NITRIC ACID; PAEONIA OFFICINALIS ROOT; PODOPHYLLUM; RUTA GRAVEOLENS FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 8; 8; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-6039_87b835b6-ecf0-4d02-8009-012c8755b748 60512-6039 HUMAN OTC DRUG CALCAREA FLUORICA CALCAREA FLUORICA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CALCIUM FLUORIDE 8 [hp_X]/1 60512-6055_1057b468-8692-456d-a852-e84c23859fd0 60512-6055 HUMAN OTC DRUG CORALLIUM RUBRUM CORALLIUM RUBRUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CORALLIUM RUBRUM EXOSKELETON 8 [hp_X]/1 60512-6060_70a3bc2c-b0da-4781-8faa-3f99470e7467 60512-6060 HUMAN OTC DRUG CUPRUM METALLICUM CUPRUM METALLICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. COPPER 8 [hp_X]/1 60512-6075_4e3ecd7f-d9d4-4049-8538-bc6fd16fbe41 60512-6075 HUMAN OTC DRUG GRAPHITES GRAPHITES PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. GRAPHITE 1 [hp_X]/1 60512-6152_b67a6747-5ec3-4c79-9768-13c45b1bbc21 60512-6152 HUMAN OTC DRUG ACETALDEHYDE ACETALDEHYDE PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACETALDEHYDE 6 [hp_X]/1 60512-6153_8f298fcc-ced3-41f6-81f5-ba4bf0ac6ac9 60512-6153 HUMAN OTC DRUG ACETANILIDUM ACETANILIDUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACETANILIDE 3 [hp_X]/1 60512-6154_8d4824b5-d184-45f3-800b-3915a0463671 60512-6154 HUMAN OTC DRUG ACETICUM ACIDUM ACETICUM ACIDUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACETIC ACID 3 [hp_X]/1 60512-6155_b1155d8b-98d8-49c7-bec2-aca2ef9bd2af 60512-6155 HUMAN OTC DRUG ACONITINUM ACONITINUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACONITINE 6 [hp_X]/1 60512-6157_0787ef5a-1f3d-405f-8048-4d1bf1a821b4 60512-6157 HUMAN OTC DRUG ADRENALINUM ADRENALINUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. EPINEPHRINE 6 [hp_X]/1 60512-6158_f0c6c22e-405e-4840-8696-e28246cee59d 60512-6158 HUMAN OTC DRUG ADRENOCORTICOTROPHIN ADRENOCORTICOTROPHIN PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CORTICOTROPIN 6 [hp_X]/1 60512-6160_245a5025-e294-4e5f-9db8-6321aba4156e 60512-6160 HUMAN OTC DRUG AGARICINUM AGARICINUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AGARICIC ACID 3 [hp_X]/1 60512-6161_e030028c-1409-4ff7-a96d-f5b4ae8f4000 60512-6161 HUMAN OTC DRUG ALLOXANUM ALLOXANUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALLOXAN 6 [hp_X]/1 60512-6162_84732b57-f1c1-40aa-81ec-904a5f940296 60512-6162 HUMAN OTC DRUG ALUMEN ALUMEN PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALUM, POTASSIUM 3 [hp_X]/1 60512-6163_13ae0d37-c5f1-4fa7-a1c9-5387e82c38f4 60512-6163 HUMAN OTC DRUG ALUMINIUM MURIATICUM ALUMINIUM MURIATICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALUMINUM CHLORIDE 3 [hp_X]/1 60512-6171_9c42283b-af8f-46d6-b824-c3c26167064e 60512-6171 HUMAN OTC DRUG AMMONIUM MURIATICUM AMMONIUM MURIATICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AMMONIUM CHLORIDE 1 [hp_X]/1 60512-6173_95763f2e-79ff-410b-8ef9-caeac33b2029 60512-6173 HUMAN OTC DRUG AMMONIUM PHOSPHORICUM AMMONIUM PHOSPHORICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AMMONIUM PHOSPHATE, DIBASIC 3 [hp_X]/1 60512-6176_de300e22-fcd8-4c97-917e-d04682f0bc75 60512-6176 HUMAN OTC DRUG AMMONIUM VALERIANICUM AMMONIUM VALERIANICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AMMONIUM VALERATE 2 [hp_X]/1 60512-6179_2dec9d72-244b-4ff0-b11f-6d8d70d9d959 60512-6179 HUMAN OTC DRUG AMYL NITROSUM AMYL NITROSUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AMYL NITRITE 6 [hp_X]/1 60512-6180_6393da1d-5b31-4974-9c36-cab67cadec8d 60512-6180 HUMAN OTC DRUG ANILINUM ANILINUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ANILINE 4 [hp_X]/1 60512-6183_b3769206-d0e3-4f92-b3ae-cad202d46f73 60512-6183 HUMAN OTC DRUG ANTIPYRINUM ANTIPYRINUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ANTIPYRINE 6 [hp_X]/1 60512-6184_a7f9defd-737a-4c5b-bc4a-b1a1e13dce1a 60512-6184 HUMAN OTC DRUG APIOLUM APIOLUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. 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SELENICEREUS GRANDIFLORUS STEM 3 [hp_X]/1 60512-6561_7dcb699c-d773-4a5e-9c55-1161c3597ecb 60512-6561 HUMAN OTC DRUG CALENDULA OFFICINALIS CALENDULA OFFICINALIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/1 60512-6566_87ed270f-d45a-487b-8cb0-fca9be8a55ff 60512-6566 HUMAN OTC DRUG CAPSICUM ANNUUM CAPSICUM ANNUUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CAPSICUM 3 [hp_X]/1 60512-6568_cfea5887-e609-4387-9df4-801ec35d7674 60512-6568 HUMAN OTC DRUG CARDUUS MARIANUS CARDUUS MARIANUS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. MILK THISTLE 1 [hp_X]/1 60512-6582_fdcb1441-b829-4ddf-a5b9-1a51624261ae 60512-6582 HUMAN OTC DRUG CETRARIA ISLANDICA CETRARIA ISLANDICA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CETRARIA ISLANDICA SUBSP. ISLANDICA 1 [hp_X]/1 60512-6585_5f047a70-8592-422b-94f8-242231383f91 60512-6585 HUMAN OTC DRUG CHELIDONIUM MAJUS CHELIDONIUM MAJUS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CHELIDONIUM MAJUS 1 [hp_X]/1 60512-6598_d95b1a8c-20bc-4887-83b4-ab8bff08f8cf 60512-6598 HUMAN OTC DRUG CIMICIFUGA RACEMOSA CIMICIFUGA RACEMOSA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACTAEA CIMICIFUGA ROOT 1 [hp_X]/1 60512-6599_e6ea7416-1dda-43a7-aeff-9ef4a065eca4 60512-6599 HUMAN OTC DRUG ANTHEMIS NOBILIS ANTHEMIS NOBILIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CHAMOMILE 1 [hp_X]/1 60512-6600_b3174f9c-8641-4390-8209-9579d3233b76 60512-6600 HUMAN OTC DRUG CINCHONA OFFICINALIS CINCHONA OFFICINALIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CINCHONA OFFICINALIS BARK 2 [hp_X]/1 60512-6608_c3ac8e12-a1a6-4174-abf5-b71a338e5bdf 60512-6608 HUMAN OTC DRUG COCCULUS INDICUS COCCULUS INDICUS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ANAMIRTA COCCULUS SEED 4 [hp_X]/1 60512-6611_fa025acb-aadf-4771-961d-03bfee48bccc 60512-6611 HUMAN OTC DRUG COFFEA CRUDA COFFEA CRUDA PELLET ORAL 19970729 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARABICA COFFEE BEAN 1 [hp_X]/1 60512-6613_a85c7e5a-7cbb-4401-aa37-27b0c24cde96 60512-6613 HUMAN OTC DRUG COLCHICUM AUTUMNALE COLCHICUM AUTUMNALE PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. COLCHICUM AUTUMNALE BULB 3 [hp_X]/1 60512-6614_b726d3cc-0589-4abd-9d8f-3f4e0df31693 60512-6614 HUMAN OTC DRUG COLLINSONIA CANADENSIS COLLINSONIA CANADENSIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. COLLINSONIA CANADENSIS ROOT 1 [hp_X]/1 60512-6615_c3afa8e0-ccb7-43ea-9fa4-ac5071bcf382 60512-6615 HUMAN OTC DRUG COLOCYNTHIS COLOCYNTHIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CITRULLUS COLOCYNTHIS FRUIT PULP 3 [hp_X]/1 60512-6618_a75374e2-a98b-4267-9716-2481e5374a41 60512-6618 HUMAN OTC DRUG CONIUM MACULATUM CONIUM MACULATUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CONIUM MACULATUM FLOWERING TOP 3 [hp_X]/1 60512-6634_777fd8ce-4c4c-4cba-a31b-2b0b2131b830 60512-6634 HUMAN OTC DRUG CYCLAMEN EUROPAEUM CYCLAMEN EUROPAEUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CYCLAMEN PURPURASCENS TUBER 3 [hp_X]/1 60512-6643_b428c3f0-14c5-441d-a208-d39d3ad9e236 60512-6643 HUMAN OTC DRUG DIGITALIS PURPUREA DIGITALIS PURPUREA PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. DIGITALIS 8 [hp_X]/1 60512-6644_c2a9b088-a42d-4b81-ac1a-0a1ad8319599 60512-6644 HUMAN OTC DRUG DIOSCOREA VILLOSA DIOSCOREA VILLOSA PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. DIOSCOREA VILLOSA ROOT 1 [hp_X]/1 60512-6646_d3bab2f8-aa0b-4573-805f-dd1b2e6612d0 60512-6646 HUMAN OTC DRUG DOLICHOS PRURIENS DOLICHOS PRURIENS PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. MUCUNA PRURIENS FRUIT TRICHOME 1 [hp_X]/1 60512-6650_efb05de7-53bb-4623-8dc3-8cdb296e2087 60512-6650 HUMAN OTC DRUG ECHINACEA ANGUSTIFOLIA ECHINACEA ANGUSTIFOLIA PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ECHINACEA ANGUSTIFOLIA 1 [hp_X]/1 60512-6651_72bfae31-b7e6-4ca2-87d4-d7e54efa9b18 60512-6651 HUMAN OTC DRUG ECHINACEA PURPUREA ECHINACEA PURPUREA PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ECHINACEA PURPUREA 1 [hp_X]/1 60512-6669_80b01d6e-6ad8-4f8e-82dd-600f50b117fb 60512-6669 HUMAN OTC DRUG EUCALYPTUS GLOBULUS EUCALYPTUS GLOBULUS PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. EUCALYPTUS GLOBULUS LEAF 1 [hp_X]/1 60512-6695_700fa09c-5049-427a-a655-a91b2281a9fd 60512-6695 HUMAN OTC DRUG FUCUS VESICULOSUS FUCUS VESICULOSUS PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. FUCUS VESICULOSUS 1 [hp_X]/1 60512-6780_7085e720-9fd4-4314-b945-832464d51f22 60512-6780 HUMAN OTC DRUG LEDUM PALUSTRE LEDUM PALUSTRE PELLET ORAL 19970131 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC LEDUM PALUSTRE TWIG 1 [hp_X]/1 60512-6997_2880f07e-526d-409b-8cbd-3dad8561ca5c 60512-6997 HUMAN OTC DRUG SYZYGIUM JAMBOLANUM SYZYGIUM JAMBOLANUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SYZYGIUM JAMBOS SEED 3 [hp_X]/1 60512-6998_0426b0d8-40d4-4319-8290-a14780b45a32 60512-6998 HUMAN OTC DRUG TABACUM TABACUM PELLET ORAL 19990413 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC TOBACCO LEAF 3 [hp_X]/1 60512-7101_cafb8adf-a8f6-46f1-8183-552091dffe21 60512-7101 HUMAN OTC DRUG AMBRA GRISEA AMBRA GRISEA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AMBERGRIS 2 [hp_X]/1 60512-7120_f72d8665-37bd-4543-a919-23b6556c5057 60512-7120 HUMAN OTC DRUG COCCUS CACTI COCCUS CACTI PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. DACTYLOPIUS COCCUS WHOLE 1 [hp_X]/1 60512-7126_357e9ef5-2455-4304-b7cc-7e4f1f4ca2e7 60512-7126 HUMAN OTC DRUG INFLUENZINUM INFLUENZINUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. INFLUENZA A VIRUS; INFLUENZA B VIRUS 9; 9 [hp_C]/1; [hp_C]/1 60512-7155_e5ab9e70-07ac-497d-90b5-a33aca3da380 60512-7155 HUMAN OTC DRUG CINA CINA PELLET ORAL 19970714 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARTEMISIA CINA FLOWER 1 [hp_X]/1 60512-8001_10adc95b-429b-4b77-9afd-ee7435778e1d 60512-8001 HUMAN OTC DRUG AURUM METALLICUM AURUM METALLICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. GOLD 8 [hp_X]/1 60512-8002_e7ba8913-2369-4373-8eb3-e8dd160f998f 60512-8002 HUMAN OTC DRUG ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/1 60512-8010_316be821-1be3-465f-8097-722e90bf094b 60512-8010 HUMAN OTC DRUG CALCAREA FLUORICA CALCAREA FLUORICA TABLET, CHEWABLE ORAL 20140228 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM FLUORIDE 6 [hp_X]/1 60512-8011_e0c8a652-2ab7-4b14-a066-7df2b88e0fff 60512-8011 HUMAN OTC DRUG CALCAREA FLUORICA CALCAREA FLUORICA TABLET, CHEWABLE ORAL 20140228 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM FLUORIDE 12 [hp_X]/1 60512-8012_4f652d69-4f9a-4b95-924f-610f154118e6 60512-8012 HUMAN OTC DRUG CALCAREA PHOSPHORICA CALCAREA PHOSPHORICA TABLET, CHEWABLE ORAL 20140313 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM PHOSPHATE 6 [hp_X]/1 60512-8014_791ae06f-a790-43a7-ab3b-fc5594f20b07 60512-8014 HUMAN OTC DRUG CALCAREA PHOSPHORICA CALCAREA PHOSPHORICA TABLET, CHEWABLE ORAL 20140313 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM PHOSPHATE 12 [hp_X]/1 60512-8015_9cb94a8b-ecd6-42af-ad86-f074fe1336c0 60512-8015 HUMAN OTC DRUG CALCAREA SULPHURICA CALCAREA SULPHURICA TABLET, CHEWABLE ORAL 20140314 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM SULFATE 6 [hp_X]/1 60512-8016_41bdf49f-9ee2-47d7-938d-8df8be6e1a11 60512-8016 HUMAN OTC DRUG CALCAREA SULPHURICA CALCAREA SULPHURICA TABLET, CHEWABLE ORAL 20140314 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM SULFATE 12 [hp_X]/1 60512-8017_59db0646-8bbb-49b3-95de-e3280d6a4855 60512-8017 HUMAN OTC DRUG FERRUM PHOSPHORICUM FERRUM PHOSPHORICUM TABLET, CHEWABLE ORAL 20140314 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC FERRUM PHOSPHORICUM 6 [hp_X]/1 60512-8018_a8a08a52-8622-4516-b9e3-7ec7e3056f63 60512-8018 HUMAN OTC DRUG FERRUM PHOSPHORICUM FERRUM PHOSPHORICUM TABLET, CHEWABLE ORAL 20140314 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC FERRUM PHOSPHORICUM 12 [hp_X]/1 60512-8019_da8a2430-88cb-41b7-98a0-3643f50f4c7c 60512-8019 HUMAN OTC DRUG KALI MURIATICUM KALI MURIATICUM TABLET, CHEWABLE ORAL 20140317 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC POTASSIUM CHLORIDE 6 [hp_X]/1 60512-8020_65d98509-6652-4f21-8412-f9d0decd8020 60512-8020 HUMAN OTC DRUG KALI MURIATICUM KALI MURIATICUM TABLET, CHEWABLE ORAL 20140317 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC POTASSIUM CHLORIDE 12 [hp_X]/1 60512-8021_cc8bcc3f-549b-4315-8791-bc310343e87f 60512-8021 HUMAN OTC DRUG KALI PHOSPHORICUM KALI PHOSPHORICUM TABLET, CHEWABLE ORAL 20140317 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC POTASSIUM PHOSPHATE, DIBASIC 6 [hp_X]/1 60512-8022_fbf9d194-3782-41dc-9382-9b9aa8e5515a 60512-8022 HUMAN OTC DRUG KALI PHOSPHORICUM KALI PHOSPHORICUM TABLET, CHEWABLE ORAL 20140317 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC POTASSIUM PHOSPHATE, DIBASIC 12 [hp_X]/1 60512-8023_e07c4129-87d7-4ffb-9259-561568930826 60512-8023 HUMAN OTC DRUG KALI SULPHURICUM KALI SULPHURICUM TABLET, CHEWABLE ORAL 20140319 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC POTASSIUM SULFATE 6 [hp_X]/1 60512-8024_84b41571-41a8-4318-a283-bd095d76a5db 60512-8024 HUMAN OTC DRUG KALI SULPHURICUM KALI SULPHURICUM TABLET, CHEWABLE ORAL 20140319 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC POTASSIUM SULFATE 12 [hp_X]/1 60512-8025_b9dc06ac-a4f3-44ee-8c89-a4bedb7dce8d 60512-8025 HUMAN OTC DRUG MAGNESIA PHOSPHORICA MAGNESIA PHOSPHORICA TABLET, CHEWABLE ORAL 20140319 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC MAGNESIUM PHOSPHATE, DIBASIC 6 [hp_X]/1 60512-8026_f0010789-6707-4842-953c-f3f074448d63 60512-8026 HUMAN OTC DRUG MAGNESIA PHOSPHORICA MAGNESIA PHOSPHORICA TABLET, CHEWABLE ORAL 20140319 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC MAGNESIUM PHOSPHATE, DIBASIC 12 [hp_X]/1 60512-8027_b0bc737c-b9a8-4c42-adf9-50f8ca6ae246 60512-8027 HUMAN OTC DRUG NATRUM MURIATICUM NATRUM MURIATICUM TABLET, CHEWABLE ORAL 20140320 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SODIUM CHLORIDE 6 [hp_X]/1 60512-8028_b8d4a434-96e7-4fc0-b4b2-8259374a5ff0 60512-8028 HUMAN OTC DRUG NATRUM MURIATICUM NATRUM MURIATICUM TABLET, CHEWABLE ORAL 20140320 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SODIUM CHLORIDE 12 [hp_X]/1 60512-8029_68e922da-3699-4296-aa98-684e70479672 60512-8029 HUMAN OTC DRUG NATRUM PHOSPHORICUM NATRUM PHOSPHORICUM TABLET, CHEWABLE ORAL 20140320 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SODIUM PHOSPHATE, DIBASIC 6 [hp_X]/1 60512-8030_0152ac21-7ce4-47e4-88f4-e52f60f257d9 60512-8030 HUMAN OTC DRUG NATRUM PHOSPHORICUM NATRUM PHOSPHORICUM TABLET, CHEWABLE ORAL 20140320 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SODIUM PHOSPHATE, DIBASIC 12 [hp_X]/1 60512-8031_73e128ba-b414-4d87-89f6-b5ee06032d6a 60512-8031 HUMAN OTC DRUG NATRUM SULPHURICUM NATRUM SULPHURICUM TABLET, CHEWABLE ORAL 20140325 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SODIUM SULFATE 6 [hp_X]/1 60512-8032_532924b7-d092-4bef-a044-ef748b59d0d3 60512-8032 HUMAN OTC DRUG NATRUM SULPHURICUM NATRUM SULPHURICUM TABLET, CHEWABLE ORAL 20140325 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SODIUM SULFATE 12 [hp_X]/1 60512-8033_3a93db3e-8251-48d1-85a5-ea63f9448c61 60512-8033 HUMAN OTC DRUG SILICEA SILICEA TABLET, CHEWABLE ORAL 20140326 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SILICON DIOXIDE 6 [hp_X]/1 60512-8034_cc338d30-14b0-4763-8e55-cac2c7521ae1 60512-8034 HUMAN OTC DRUG SILICEA SILICEA TABLET, CHEWABLE ORAL 20140326 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SILICON DIOXIDE 12 [hp_X]/1 60512-8035_336b7627-d812-449a-883b-a59c92992a0b 60512-8035 HUMAN OTC DRUG DIAMITE CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA TABLET, CHEWABLE ORAL 20140328 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM FLUORIDE; CALCIUM PHOSPHATE; CALCIUM SULFATE; FERRUM PHOSPHORICUM; MAGNESIUM PHOSPHATE, DIBASIC; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; SODIUM SULFATE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-8036_600bb4d6-f18a-48a3-b89b-dcc12e7cb4b5 60512-8036 HUMAN OTC DRUG DIAMITE CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA TABLET, CHEWABLE ORAL 20140328 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM FLUORIDE; CALCIUM PHOSPHATE; CALCIUM SULFATE; FERRUM PHOSPHORICUM; MAGNESIUM PHOSPHATE, DIBASIC; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; SODIUM SULFATE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-9011_1f56545f-3b70-41da-a1cb-8fa35ac8dec5 60512-9011 HUMAN OTC DRUG COUGH AND COLD KIDS RELIEF DROSERA, ARNICA MONTANA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, BELLADONNA, COCCUS CACTI, STANNUM METALLICUM SYRUP ORAL 20120808 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CETRARIA ISLANDICA SUBSP. ISLANDICA; DROSERA ROTUNDIFOLIA; IPECAC; PROTORTONIA CACTI; TIN 3; 3; 3; 1; 1; 3; 3; 3 [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL 60512-9021_234c0f45-415b-4c31-a8e7-2ec2034e1858 60512-9021 HUMAN OTC DRUG COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF DROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, BELLADONNA, COCCUS CACTI, STANNUM METALLICUM, CHAMOMILLA, COFFEA CRUDA SYRUP ORAL 20110228 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARABICA COFFEE BEAN; ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CETRARIA ISLANDICA SUBSP. ISLANDICA; DROSERA ROTUNDIFOLIA; MATRICARIA RECUTITA; PROTORTONIA CACTI; TIN 4; 3; 3; 3; 1; 1; 4; 3; 3 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL 60512-9054_cbb42dcc-3ad3-42be-89f8-64942e5ffab2 60512-9054 HUMAN OTC DRUG TINNITUS RELIEF KALIUM BROMATUM, NUX VOMICA, CHINA RUBRA, SULPHUR, SANGUINARIA CANADENSIS, DULCAMARA, HYDRASTIS CANADENSIS, ARNICA MONTANA, BRYONIA ALBA, CAUSTICUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; GOLDENSEAL; POTASSIUM BROMIDE; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA STEM; STRYCHNOS NUX-VOMICA SEED; SULFUR 4; 4; 6; 4; 3; 3; 4; 3; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-9055_24655d36-7d53-4133-9cb4-eed02b8099c5 60512-9055 HUMAN OTC DRUG DIARRHEA RELIEF CHINA, BRYONIA ALBA, CHAMOMILLA, COLOCYNTHIS, IPECA, BELLADONNA, POTENTILLA ANSERINA PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ATROPA BELLADONNA WHOLE; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; MATRICARIA CHAMOMILLA WHOLE; POTENTILLA ANSERINA WHOLE 3; 4; 3; 4; 4; 3; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-9056_5ab5a64f-b7b6-43df-81e8-c81badc6d214 60512-9056 HUMAN OTC DRUG FIBROMYALGIA RELIEF CALCAREA PHOSPHORICA, IGNATIA AMARA, CAUSTICUM, RHUS TOXICODENDRON, MAGNESIA PHOSPHORICA, BRYONIA ALBA, ARNICA MONTANA, HYPERICUM, CANTHARIS, KALI BICHROMICUM, PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARNICA MONTANA; BRYONIA ALBA ROOT; CALCIUM PHOSPHATE; CAUSTICUM; HYPERICUM PERFORATUM; LYTTA VESICATORIA; MAGNESIUM PHOSPHATE, DIBASIC; POTASSIUM DICHROMATE; STRYCHNOS IGNATII SEED; TOXICODENDRON RADICANS LEAF 9; 7; 7; 7; 9; 9; 7; 9; 9; 7 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 60512-9057_c117c170-0ce5-49e4-b7f1-f7e604d52811 60512-9057 HUMAN OTC DRUG DIGESTION RELIEF DOLICHOS PRURIENS, LYCOPODIUM CLAVATUM, LEPTANDRA VIRGINICA, CARDUUS MARIANUS, CHELIDONIUM MAJUS, BOLDO PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; MUCUNA PRURIENS FRUIT TRICHOME; PEUMUS BOLDUS LEAF; VERONICASTRUM VIRGINICUM ROOT 1; 3; 3; 3; 1; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-9058_e74a6496-0c32-40e5-8f83-52a8759d4688 60512-9058 HUMAN OTC DRUG ARNICA RELIEF ARNICA MONTANA 10X, 30X, 100X PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARNICA MONTANA 10 [hp_X]/1 60512-9059_c7c9c1f3-e944-487e-b2ef-fa51d9335e13 60512-9059 HUMAN OTC DRUG HEMORRHOIDS RELIEF AESCULUS HIPPOCASTANUM, HAMAMELIS VIRGINIANA, PAEONIA OFFICINALIS, COLLINSONIA, TEUCRIUM MARUM, VERBASCUM, BOLDO, SULPHUR, SODIUM NITRATE, RATANHIA, ACIDUM NITRICUM, NATRUM MURIATICUM, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, APIS MELLIFICA PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. APIS MELLIFERA; COLLINSONIA CANADENSIS ROOT; HORSE CHESTNUT; KRAMERIA LAPPACEA ROOT; NITRIC ACID; PAEONIA OFFICINALIS ROOT; PEUMUS BOLDUS LEAF; PODOPHYLLUM PELTATUM ROOT; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE; SODIUM NITRATE; SULFUR; TEUCRIUM MARUM; VERBASCUM THAPSUS; WITCH HAZEL 4; 3; 1; 3; 8; 3; 1; 4; 8; 8; 3; 4; 3; 3; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-9060_7fc50292-4009-4941-b5e0-29e05f03f92c 60512-9060 HUMAN OTC DRUG TEETHING KIDS RELIEF CHAMOMILLA, ARNICA MONTANA, BORAX, HYPERICUM PERFORATUM LIQUID ORAL 20080818 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; SODIUM BORATE 5; 5; 5; 5 [hp_C]/25mL; [hp_C]/25mL; [hp_C]/25mL; [hp_C]/25mL 60512-9061_ed44f9b2-1193-4bb5-b09a-c1e4e63a9507 60512-9061 HUMAN OTC DRUG COUGH AND COLD KIDS RELIEF DROSERA, ARNICA MONTANA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, BELLADONNA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM SYRUP ORAL 20080818 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CETRARIA ISLANDICA SUBSP. ISLANDICA; CORALLIUM RUBRUM EXOSKELETON; DROSERA ROTUNDIFOLIA FLOWERING TOP; IPECAC; PROTORTONIA CACTI; TIN 3; 3; 3; 1; 3; 1; 3; 3; 3 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL 60512-9062_b8f22738-2143-48d4-92aa-6fb0834f4bb3 60512-9062 HUMAN OTC DRUG FLU KIDS RELIEF ANAS BARBARIAE HEPATIS ET CORDIS EXTRACTUM LIQUID ORAL 20090406 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/25mL 60512-9063_15df66c3-bb76-467a-a732-5fc39b46c47e 60512-9063 HUMAN OTC DRUG EARACHE KIDS RELIEF FERRUM PHOSPHORICUM, CAPSICUM ANNUUM, PYROGENIUM, ARSENICUM ALBUM, BELLADONNA LIQUID ORAL 20080818 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARSENIC TRIOXIDE; ATROPA BELLADONNA; FERRUM PHOSPHORICUM; RANCID BEEF; RED PEPPER 30; 30; 30; 30; 30 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL 60512-9064_2d234e85-3d18-4e0b-942d-3246137b711d 60512-9064 HUMAN OTC DRUG CALM KIDS RELIEF ASAFOETIDA, IGNATIA AMARA, VALERIANA OFFICINALIS, AVENA SATIVA, ARGENTUM NITRICUM, TARENTULA HISPANA, HYOSCYAMUS NIGER, PAEONIA OFFICINALIS, STRAMONIUM, COCCULUS INDICUS SYRUP ORAL 20080818 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ANAMIRTA COCCULUS SEED; ASAFETIDA; AVENA SATIVA FLOWERING TOP; DATURA STRAMONIUM; HYOSCYAMUS NIGER; LYCOSA TARANTULA; PAEONIA OFFICINALIS ROOT; SILVER NITRATE; STRYCHNOS IGNATII SEED; VALERIAN 8; 8; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 60512-9065_694ab851-5a46-4cd3-bda1-bbd72024369c 60512-9065 HUMAN OTC DRUG COLIC KIDS RELIEF COLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSA LIQUID ORAL 20080818 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA 6; 6; 6; 6 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL 60512-9068_80142f3a-0bf0-4a08-92c6-b3806f8b0d3c 60512-9068 HUMAN OTC DRUG JET LAG RELIEF ARNICA MONTANA, BELLIS PERENNIS, CHAMOMILLA, IPECACUANHA, LYCOPODIUM CLAVATUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARNICA MONTANA; BELLIS PERENNIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; MATRICARIA CHAMOMILLA WHOLE 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-9069_7e30579a-e6fc-4ce8-a1c2-0434412227de 60512-9069 HUMAN OTC DRUG TRAVEL SICKNESS RELIEF COCCULUS INDICUS, VINCA MINOR, VALERIANA OFFICINALIS, PULSATILLA, NITROGLYCERIN, PLUMBUM ACETICUM, ARGENTUM NITRICUM, ARTEMISIA VULGARIS PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ANAMIRTA COCCULUS SEED; ARTEMISIA VULGARIS ROOT; LEAD ACETATE; NITROGLYCERIN; PULSATILLA VULGARIS; SILVER NITRATE; VALERIAN; VINCA MINOR 8; 1; 8; 6; 4; 6; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60512-9077_a02a5db7-ffe3-4c8f-8bf2-0b146856e42a 60512-9077 HUMAN OTC DRUG ALLERGY KIDS RELIEF PULSATILLA, ALLIUM CEPA, ARSENICUM ALBUM, NUX VOMICA, EUPHRASIA OFFICINALIS, SABADILLA, STICTA PULMONARIA, ARALIA RACEMOSA, CUPRUM METALLICUM LIQUID ORAL 20090420 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; COPPER; EUPHRASIA STRICTA; LOBARIA PULMONARIA; ONION; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; STRYCHNOS NUX-VOMICA SEED 6; 8; 8; 6; 6; 6; 8; 6; 6 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL 60512-9079_658bde6b-3541-4f37-ae1f-e76e275bd2e1 60512-9079 HUMAN OTC DRUG PAIN AND FEVER KIDS RELIEF ARNICA MONTANA, FERRUM PHOSPHORICUM, HYPERICUM PERFORATUM, BELLADONNA, THUJA OCCIDENTALIS, LEDUM PALUSTRE LIQUID ORAL 20100510 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA; ATROPA BELLADONNA; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; THUJA OCCIDENTALIS LEAFY TWIG 8; 8; 8; 8; 8; 8 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL 60512-9081_79e3fd0b-314d-4b65-8e2d-e05098cc2064 60512-9081 HUMAN OTC DRUG COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF DROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, BELLADONNA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CHAMOMILLA, COFFEA CRUDA SYRUP ORAL 20110228 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARABICA COFFEE BEAN; ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CETRARIA ISLANDICA SUBSP. ISLANDICA; CORALLIUM RUBRUM EXOSKELETON; DROSERA ROTUNDIFOLIA FLOWERING TOP; MATRICARIA RECUTITA; PROTORTONIA CACTI; TIN 4; 3; 3; 3; 1; 3; 1; 4; 3; 3 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL 60512-9082_fe7c506b-3d1e-4766-9785-2333ecf7de00 60512-9082 HUMAN OTC DRUG ARNICA PLUS ARNICA MONTANA, HYPERICUM PERFORATUM CREAM TOPICAL 20110601 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA; HYPERICUM PERFORATUM 1; 1 [hp_X]/50g; [hp_X]/50g 60512-9083_b7de38ee-a474-4986-bc94-f1ff734349f3 60512-9083 HUMAN OTC DRUG GAS AND COLIC KIDS RELIEF COLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSA LIQUID ORAL 20110822 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA 6; 6; 6; 6 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL 60512-9084_b289eac0-5658-4271-b797-5b87e576248b 60512-9084 HUMAN OTC DRUG COUGH AND COLD NIGHTTIME REAL RELIEF DROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, BELLADONNA, COCCUS CACTI, STANNUM METALLICUM, CHAMOMILLA, COFFEA CRUDA SYRUP ORAL 20120321 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARABICA COFFEE BEAN; ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CETRARIA ISLANDICA SUBSP. ISLANDICA; DROSERA ROTUNDIFOLIA; MATRICARIA RECUTITA; PROTORTONIA CACTI; TIN 4; 3; 3; 3; 1; 1; 4; 3; 3 [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL 60512-9085_34856a8b-feaa-44c6-b51a-baf650365e8d 60512-9085 HUMAN OTC DRUG Cough and Cold Real Relief DROSERA, ARNICA MONTANA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, BELLADONNA, COCCUS CACTI, CORRALLIUM RUBRUM, STANNUM METALLICUM SYRUP ORAL 20120417 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CETRARIA ISLANDICA SUBSP. ISLANDICA; CORALLIUM RUBRUM EXOSKELETON; DROSERA ROTUNDIFOLIA; IPECAC; PROTORTONIA CACTI; TIN 3; 3; 3; 1; 3; 1; 3; 3; 3 [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL 60512-9086_46668cbd-c581-4c65-94a8-4e19b5b041ef 60512-9086 HUMAN OTC DRUG KIDS RELIEF ARNICA ARNICA MONTANA, HYPERICUM PERFORATUM CREAM TOPICAL 20120315 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA; HYPERICUM PERFORATUM 1; 1 [hp_X]/50g; [hp_X]/50g 60512-9087_94d1feca-06e9-4245-8440-2e8826fd57c3 60512-9087 HUMAN OTC DRUG KIDS RELIEF CALENDULA CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, HYPERICUM PERFORATUM, PHYTOLACCA DECANDRA, CANTHARIS, SULPHUR CREAM TOPICAL 20120315 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; LYTTA VESICATORIA; PHYTOLACCA AMERICANA ROOT; SULFUR 1; 1; 3; 3; 3; 3 [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g 60512-9150_a462ba79-eda0-411b-98d1-84f2d636577a 60512-9150 HUMAN OTC DRUG APIS MELLIFICA APIS MELLIFICA PELLET ORAL 20111130 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC APIS MELLIFERA 1 [hp_X]/1 60512-9151_bf3ee20b-6d71-4ed3-8de2-a0df5a4a8961 60512-9151 HUMAN OTC DRUG CANTHARIS CANTHARIS PELLET ORAL 20111130 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC LYTTA VESICATORIA 3 [hp_X]/1 60512-9152_a5928f0b-b6e7-44af-a9ef-1196d1c7ab78 60512-9152 HUMAN OTC DRUG MAGNESIA PHOSPHORICA MAGNESIA PHOSPHORICA PELLET ORAL 20111130 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 1 [hp_X]/1 60512-9163_45a6f39c-d835-4f00-a5f6-1982f143f7e1 60512-9163 HUMAN OTC DRUG KIDS RELIEF EAR RELIEF FERRUM PHOSPHORICUM, CAPSICUM ANNUUM, PYROGENIUM, ARSENICUM ALBUM, BELLADONNA LIQUID ORAL 20140115 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARSENIC TRIOXIDE; ATROPA BELLADONNA; CAPSICUM ANNUUM WHOLE; FERRUM PHOSPHORICUM; RANCID BEEF 30; 30; 30; 30; 30 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL 60512-9164_c815a73e-e392-48f5-a2dd-a663d46297dc 60512-9164 HUMAN OTC DRUG WITH CALMING EFFECT KIDS RELIEF ASAFOETIDA, IGNATIA AMARA, VALERIANA OFFICINALIS, AVENA SATIVA, ARGENTUM NITRICUM, HYOSCYAMUS NIGER, PAEONIA OFFICINALIS, STRAMONIUM, COCCULUS INDICUS SYRUP ORAL 20130507 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ANAMIRTA COCCULUS SEED; ASAFETIDA; AVENA SATIVA FLOWERING TOP; DATURA STRAMONIUM; HYOSCYAMUS NIGER; PAEONIA OFFICINALIS ROOT; SILVER NITRATE; STRYCHNOS IGNATII SEED; VALERIAN 8; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 60512-9300_2c3d7039-62d7-485c-a13a-e6d21fb6e85a 60512-9300 HUMAN OTC DRUG ECHINACEA SUPPORT ECHINACEA PURPUREA, ZINCUM METALLICUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ECHINACEA PURPUREA; ECHINACEA PURPUREA ROOT; ZINC 6; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1 60533-001_ee4afd68-ffe9-479a-a9e4-71b6407bd70b 60533-001 HUMAN OTC DRUG Candy Coated Apple anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL 60533-002_97046468-b381-41c0-a77c-c5e1c9750eed 60533-002 HUMAN OTC DRUG Cool Clementine anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL 60533-003_39e9e628-b808-4dab-bb53-3ca7846ccbae 60533-003 HUMAN OTC DRUG Cotton candy anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL 60533-004_92761365-4a59-4e5d-8c85-d91b14928406 60533-004 HUMAN OTC DRUG Frosted cranberry anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL 60533-005_4c69c235-b624-417c-a01b-1a3ecc7352df 60533-005 HUMAN OTC DRUG Gingerhead Girl anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL 60533-006_3767936f-17f4-4a60-98b2-1eaf6e8bac40 60533-006 HUMAN OTC DRUG Lemon splash anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL 60533-007_7b4500b2-fd60-4b0d-9675-41ab6f257029 60533-007 HUMAN OTC DRUG Mango papaya anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL 60533-008_d4081072-8662-4a28-8222-d53361b06f43 60533-008 HUMAN OTC DRUG Peppermint Ice anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL 60533-009_a3c902f6-d530-4431-92d8-6a2c9950f893 60533-009 HUMAN OTC DRUG Pumpkin pie anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL 60533-010_79791b84-7ad8-4442-a449-1d82c4c255d5 60533-010 HUMAN OTC DRUG Sweet pea anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL 60533-011_884077e5-6694-424e-bf3c-0ae2ecd035ac 60533-011 HUMAN OTC DRUG Vanilla cupcake anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL 60533-012_cc972c0e-d5f0-42bf-8c5e-911b1bc55187 60533-012 HUMAN OTC DRUG Vanilla sugar anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL 60539-001_43d5c2f2-53f3-446a-81c9-a89d1b5ba98d 60539-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130531 UNAPPROVED MEDICAL GAS Respacare of Louisiana OXYGEN 99 L/100L 60541-0706_4ea06c16-dd36-40a8-950d-7f9484bec0cd 60541-0706 HUMAN OTC DRUG Moisturizing Tint SPF 30 Octinoxate, Octisalate, Oxybenzone, Avobenzone LOTION TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Hayden Caleel LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 4 g/mL; g/mL; g/mL; g/mL 60541-8407_54da8c69-3c6d-4588-9e90-9b26571af7ae 60541-8407 HUMAN OTC DRUG Octinoxate Octinoxate LOTION TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Hayden Caleel LLC OCTINOXATE .05 g/mL 60549-1129_9dc5c5d2-0af3-4e56-9203-0b536c3cc134 60549-1129 HUMAN OTC DRUG Luxury Triclosan LIQUID TOPICAL 20070401 OTC MONOGRAPH NOT FINAL part333A Tomco-Harwel Industries Inc TRICLOSAN 1.5 g/L 60549-2108_d79e5a0e-03f2-4813-9153-bd8c040d0f88 60549-2108 HUMAN OTC DRUG Satin Pink Triclosan LIQUID TOPICAL 20070401 OTC MONOGRAPH NOT FINAL part333A Tomco-Harwel Industries Inc TRICLOSAN 1.08 g/L 60555-622_5dd309f5-5c0d-49d1-a6e0-0bba7eb4bbc0 60555-622 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19820101 UNAPPROVED MEDICAL GAS Ameri-Quipt of North Carolina, Inc OXYGEN 99 L/100L 60560-1072_a81171ce-09ca-4b5d-9cb2-a66a8082d3ab 60560-1072 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20081111 UNAPPROVED MEDICAL GAS Johns Hopkins Pharmaquip OXYGEN 99 L/100L 60561-0001_acb281a9-f20b-448c-9a56-13333c57c532 60561-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030203 UNAPPROVED MEDICAL GAS Richmond Respiratory & Medical Supply OXYGEN 99 L/100L 60564-0001_fcbf1d78-6097-410e-a253-42ad81bd12c9 60564-0001 HUMAN OTC DRUG Liquid Serotonin Serotonin LIQUID ORAL 20140314 UNAPPROVED HOMEOPATHIC Pain and Stress Center Products SEROTONIN HYDROCHLORIDE 3 [hp_X]/mL 60564-0002_102f78db-431b-4e9d-b454-2cde86b095b2 60564-0002 HUMAN OTC DRUG Neuro Links 5-METHOXYTRYPTAMINE, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, GABA (GAMMA-AMINOBUTYRIC ACID), LIQUID ORAL 20141202 UNAPPROVED HOMEOPATHIC Pain & Stress Center Products .GAMMA.-AMINOBUTYRIC ACID; 5-METHOXYTRYPTAMINE; ACETYLCHOLINE CHLORIDE; DOPAMINE HYDROCHLORIDE; HISTAMINE DIHYDROCHLORIDE; LEVODOPA; MELATONIN; NOREPINEPHRINE; PHENETHYLAMINE; SEROTONIN HYDROCHLORIDE; TAURINE; TYRAMINE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 60565-010_3eb26348-a207-4eb1-a182-feabf2695581 60565-010 HUMAN OTC DRUG Cellisys EX Wrinkle Solution Emulsion Dimethicone CREAM TOPICAL 20130701 OTC MONOGRAPH FINAL part347 DN Company Co., Ltd. DIMETHICONE 2.8 mg/140mL 60565-020_8c52b243-0a6e-469a-965a-3a81079adf27 60565-020 HUMAN OTC DRUG Cellisys EX Wrinkle Solution Eye Contour Dimethicone CREAM TOPICAL 20130701 OTC MONOGRAPH FINAL part347 DN Company Co., Ltd. DIMETHICONE .51 mg/15mL 60565-030_cb04cb03-d0a7-4562-b351-ea1a98768ffb 60565-030 HUMAN OTC DRUG Easydew EX Renewal Moisture Dimethicone CREAM TOPICAL 20130701 OTC MONOGRAPH FINAL part347 DN Company Co., Ltd. DIMETHICONE .46 mg/40mL 60565-040_a2d64d57-a8e6-45ca-adc0-384cf489dbc5 60565-040 HUMAN OTC DRUG Easydew EX Mineral BB SPF45 PA PLUS PLUS Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 DN Company Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 3.97; 1.17 mg/40mL; mg/40mL; mg/40mL 60565-050_68ac73c5-339f-4220-8ea4-1851f893a016 60565-050 HUMAN OTC DRUG Easydew EX Fresh Mild SunScreen SPF50 PLUS PA PLUS PLUS PLUS Octinoxate, Titanium Dioxide, Octisalate, Octocrylene CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 DN Company Co., Ltd. OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 3; .8; .8; 1.7 mg/40mL; mg/40mL; mg/40mL; mg/40mL 60565-060_e1f16373-f565-40ce-81c4-3aa37f16ffac 60565-060 HUMAN OTC DRUG Cellisys EX Wrinkle Solution Eye Contour EGF Dimethicone CREAM TOPICAL 20130701 OTC MONOGRAPH FINAL part347 DN Company Co., Ltd. DIMETHICONE .15 mg/15mL 60568-001_b9a26361-6031-4ad7-af92-85142c52b191 60568-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130717 UNAPPROVED MEDICAL GAS Mountain West Medical Supply OXYGEN 99 L/100L 60574-4113_799f2bc8-1f84-4190-829f-cedf9abe6676 60574-4113 HUMAN PRESCRIPTION DRUG Synagis palivizumab INJECTION, SOLUTION INTRAMUSCULAR 19980619 BLA BLA103770 MedImmune, LLC PALIVIZUMAB 100 mg/mL Antibodies, Monoclonal [Chemical/Ingredient],Fusion Protein Inhibitors [MoA],Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC] 60574-4114_799f2bc8-1f84-4190-829f-cedf9abe6676 60574-4114 HUMAN PRESCRIPTION DRUG Synagis palivizumab INJECTION, SOLUTION INTRAMUSCULAR 19991209 BLA BLA103770 MedImmune, LLC PALIVIZUMAB 50 mg/.5mL Antibodies, Monoclonal [Chemical/Ingredient],Fusion Protein Inhibitors [MoA],Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC] 60575-212_62ec8ee2-4187-48d6-861b-1e586b529912 60575-212 HUMAN OTC DRUG Codar AR Chlorpheniramine Maleate, Codeine Phosphate LIQUID ORAL 20110620 OTC MONOGRAPH FINAL part341 Respa Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 2; 8 mg/5mL; mg/5mL CV 60575-313_cfbbbfc0-ceb1-42b7-927b-6dcc58e30f1f 60575-313 HUMAN OTC DRUG Tricode AR Chlorpheniramine Maleate, Codeine Phosphate, Pseudoephedrine Hydrochloride LIQUID ORAL 20110620 OTC MONOGRAPH FINAL part341 Respa Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 8; 30 mg/5mL; mg/5mL; mg/5mL CV 60575-414_ba3af78f-2f38-48c7-94bf-36416da895a5 60575-414 HUMAN OTC DRUG Tricode GF Codeine Phosphate, Guaifenesin, Pseudoephedrine Hydrochloride LIQUID ORAL 20110620 OTC MONOGRAPH FINAL part341 Respa Pharmaceuticals, Inc. CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 8; 200; 30 mg/5mL; mg/5mL; mg/5mL CV 60575-515_076f7810-5c2b-4d9b-9a69-4308cb9440ca 60575-515 HUMAN OTC DRUG CODAR D Codeine Phosphate, Pseudoephedrine Hydrochloride LIQUID ORAL 20110713 OTC MONOGRAPH FINAL part341 Respa Pharmaceuticals CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 8; 30 mg/5mL; mg/5mL CV 60575-616_1e3023d2-63bb-4367-9152-84ed9adcd90f 60575-616 HUMAN OTC DRUG Codar GF Codeine Phosphate, Guaifenesin LIQUID ORAL 20110621 OTC MONOGRAPH FINAL part341 Respa Pharmaceuticals, Inc. CODEINE PHOSPHATE; GUAIFENESIN 8; 200 mg/5mL; mg/5mL CV 60589-001_09d74dce-91c6-4283-abcb-839e27431007 60589-001 HUMAN OTC DRUG SmartRx Natural Pain Relief Sleeve ANKLE METHYL SALICYLATE LIQUID TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part348 Niche Brands, Inc. METHYL SALICYLATE 10 g/100g 60589-002_807aee49-a168-4baa-b565-2c85f76c90d4 60589-002 HUMAN OTC DRUG SmartRx Natural Pain Relief Sleeve BACK METHYL SALICYLATE LIQUID TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part348 Niche Brands, Inc. METHYL SALICYLATE 10 g/100g 60589-003_abb54a95-64a3-4f97-8f8f-7319e206285d 60589-003 HUMAN OTC DRUG SmartRx Natural Pain Relief Sleeve ELBOW METHYL SALICYLATE LIQUID TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part348 Niche Brands, Inc. METHYL SALICYLATE 10 g/100g 60589-004_7068ec27-1354-40e3-8a84-fb7efcd72788 60589-004 HUMAN OTC DRUG SmartRx Natural Pain Relief Sleeve KNEE METHYL SALICYLATE LIQUID TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part348 Niche Brands, Inc. METHYL SALICYLATE 10 g/100g 60589-005_2313847e-133f-48ca-9d87-06a6d390a99a 60589-005 HUMAN OTC DRUG SmartRx Natural Pain Relief Sleeve WRIST METHYL SALICYLATE LIQUID TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part348 Niche Brands, Inc. METHYL SALICYLATE 10 g/100g 60596-1072_908c6a59-8e2a-4ba3-bf40-28b4b0b3018d 60596-1072 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060403 UNAPPROVED MEDICAL GAS Banner Home Medical Equipment OXYGEN 99 L/100L 60608-011_206bc7b7-5a2a-4e00-9dc2-3ca2c7b681c2 60608-011 HUMAN OTC DRUG Bio-Scriptives Lidum Lidocaine CREAM TOPICAL 20100723 OTC MONOGRAPH NOT FINAL part348 BioChemics, Inc LIDOCAINE HYDROCHLORIDE 2.8 g/56g 60608-012_53efb922-1f3a-4ef4-953c-550a385afd52 60608-012 HUMAN OTC DRUG Bio-Scriptives Repiderm Benzoly Peroxide CREAM TOPICAL 20100724 OTC MONOGRAPH NOT FINAL part333D BioChemics, Inc. BENZOYL PEROXIDE 3.29 g/56g 60608-013_21203d45-e7b4-4bb2-a475-f8711a6ba65d 60608-013 HUMAN OTC DRUG Bio-Scriptives Extreme AF Tolnaftate CREAM TOPICAL 20110727 OTC MONOGRAPH FINAL part333C BioChemics, Inc. TOLNAFTATE .56 g/56.69g 60608-015_340499f2-470d-45f9-8893-0eea055d7a6a 60608-015 HUMAN OTC DRUG Bio-Scriptives Extreme PR Menthol LOTION TOPICAL 20110215 OTC MONOGRAPH NOT FINAL part348 BioChemics, Inc. MENTHOL 5.11 g/113g 60608-016_25174fb2-87a8-4a29-96f8-e0fd452b5971 60608-016 HUMAN OTC DRUG Bio-Scriptives Lidum Hemorroidal (Anorectal) Lidocaine CREAM TOPICAL 20120304 OTC MONOGRAPH FINAL part346 Bio-Scriptives, Inc. LIDOCAINE 2.8 g/56g 60608-017_fa228065-45fa-40fe-8057-18c69a1b8394 60608-017 HUMAN PRESCRIPTION DRUG Bio-Scriptives Lidum Topical Analgesic Lidocaine CREAM TOPICAL 20120307 OTC MONOGRAPH FINAL part346 Bio-Scriptives, Inc. LIDOCAINE 2.8 g/56g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 60614-1001_4d67cc93-2c3d-4a4b-bfbc-48a572d6b37d 60614-1001 HUMAN OTC DRUG The21 DAYs HAIR NUTRIENT SERUM Glycerin LIQUID TOPICAL 20131219 OTC MONOGRAPH FINAL part347 GDKCOSMETICS Co., Ltd GLYCERIN .02 g/mL 60615-0001_dd248fc1-605c-4703-ac0e-0d56caa778af 60615-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20010109 UNAPPROVED MEDICAL GAS Advacare Medical Services, Inc. dba Petersen Medical OXYGEN 99 L/100L 60621-033_dc890dd5-ab65-4d2f-816d-ecd23ea77734 60621-033 HUMAN PRESCRIPTION DRUG Theophylline Theophylline Anhydrous SOLUTION ORAL 20141103 ANDA ANDA091586 Cranbury Pharmaceuticals Inc THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 60630-077_dd0ab94d-0460-4069-bb82-cc2f6ed32a99 60630-077 HUMAN OTC DRUG DenTek Instant Pain Relief Maximum Strength Benzocaine LIQUID TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part356 DenTek Oral Care. Inc. BENZOCAINE 200 mg/mL 60631-040_13ea2d5f-a13b-4cc5-aa17-4e44b12ca15c 60631-040 HUMAN PRESCRIPTION DRUG Edarbi Azilsartan kamedoxomil TABLET ORAL 20130201 NDA NDA200796 Arbor Pharmaceuticals Ireland Limited AZILSARTAN KAMEDOXOMIL 40 mg/1 Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE] 60631-080_13ea2d5f-a13b-4cc5-aa17-4e44b12ca15c 60631-080 HUMAN PRESCRIPTION DRUG Edarbi Azilsartan kamedoxomil TABLET ORAL 20130201 NDA NDA200796 Arbor Pharmaceuticals Ireland Limited AZILSARTAN KAMEDOXOMIL 80 mg/1 Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE] 60631-412_c341db04-8c98-4595-aee6-bbb2d7d646a6 60631-412 HUMAN PRESCRIPTION DRUG Edarbyclor Azilsartan kamedoxomil and chlorthalidone TABLET ORAL 20130201 NDA NDA202331 Arbor Pharmaceuticals Ireland Limited AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE 40; 12.5 mg/1; mg/1 Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 60631-425_c341db04-8c98-4595-aee6-bbb2d7d646a6 60631-425 HUMAN PRESCRIPTION DRUG Edarbyclor Azilsartan kamedoxomil and chlorthalidone TABLET ORAL 20130201 NDA NDA202331 Arbor Pharmaceuticals Ireland Limited AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE 40; 25 mg/1; mg/1 Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 60635-118_331ac750-fc90-11e3-a3ac-0800200c9a66 60635-118 HUMAN PRESCRIPTION DRUG Varithena polidocanol KIT 20140710 NDA NDA205098 Biocompatibles, Inc. 60635-133_331ac750-fc90-11e3-a3ac-0800200c9a66 60635-133 HUMAN PRESCRIPTION DRUG Varithena polidocanol KIT 20131125 NDA NDA205098 Biocompatibles, Inc. 60637-001_7c92404c-49be-411c-a5c4-6e2e893c2744 60637-001 HUMAN OTC DRUG Justice ANTI BAC HAND SANITIZER Alcohol LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-002_021bcecd-d3dd-4176-9994-988f6b3def1f 60637-002 HUMAN OTC DRUG Justice ANTI BAC HAND SANITIZER Alcohol LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-003_4fe453c9-c116-410a-9d12-dfff125e534c 60637-003 HUMAN OTC DRUG Justice ANTI BAC HAND SANITIZER Alcohol LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-004_5bd0d479-0609-4af0-8e8c-5db442e90097 60637-004 HUMAN OTC DRUG Justice ANTI BAC HAND SANITIZER Alcohol LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-005_bc36cf45-2031-4bab-8906-1fcbba702e6f 60637-005 HUMAN OTC DRUG Justice ANTI BAC HAND SANITIZER Alcohol LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-006_715b4ea9-8e63-4ed5-9532-245c68077309 60637-006 HUMAN OTC DRUG Justice Vanilla ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140516 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-007_8c51f761-78fa-4024-b6fb-a362f6206c19 60637-007 HUMAN OTC DRUG Justice Mixed Berry ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140516 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-008_86c7c6ab-74ee-4ef2-bd1d-81bab386a537 60637-008 HUMAN OTC DRUG Justice Strawberry Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140516 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-009_a4716cdd-a5bb-4531-9ac0-9c592ac06643 60637-009 HUMAN OTC DRUG Justice Grape Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140516 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-010_182d0d94-63b3-41fd-b78a-fd0cf1886a60 60637-010 HUMAN OTC DRUG Justice Strawberry Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140516 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-011_6cc00eb3-70f0-4351-a4ee-4321317fc1e6 60637-011 HUMAN OTC DRUG Justice Vanilla Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140516 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-012_c275cce3-a2eb-428b-a12f-12afdb62ca21 60637-012 HUMAN OTC DRUG Justice Mixed berry Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-013_0f729c5c-a53b-4a0b-b8f1-8176981dbd65 60637-013 HUMAN OTC DRUG Justice Mixed berry Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-014_c4182690-26e8-4925-9984-e59ec07efe32 60637-014 HUMAN OTC DRUG Justice Vanilla Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-015_f86e6489-7079-49bc-9275-47179d733919 60637-015 HUMAN OTC DRUG Justice Blue berry Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-016_03ebb4d0-15ca-4e46-ae0a-37ce30448269 60637-016 HUMAN OTC DRUG Justice Cotton Candy Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-017_52a1dc8c-f477-4847-a78d-116abb691731 60637-017 HUMAN OTC DRUG Justice Fruit Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-018_a81a9999-25bd-4a30-9e67-ec7563f78338 60637-018 HUMAN OTC DRUG Justice Vanilla Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-019_506d6b7a-0c5e-455f-8a42-618d09dfb498 60637-019 HUMAN OTC DRUG Justice Grape Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60637-020_e6099e9c-539a-4fe1-988e-c7811f0c0780 60637-020 HUMAN OTC DRUG Justice Cotton Candy Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20141113 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL 60640-3688_771e79ab-4ac6-4439-8630-bbf579259fbe 60640-3688 HUMAN PRESCRIPTION DRUG Lollicaine Bubble Gum Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Centrix, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 60640-3690_771e79ab-4ac6-4439-8630-bbf579259fbe 60640-3690 HUMAN PRESCRIPTION DRUG Lollicaine Cherry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Centrix, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 60640-3692_771e79ab-4ac6-4439-8630-bbf579259fbe 60640-3692 HUMAN PRESCRIPTION DRUG Lollicaine Mint Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Centrix, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 60640-3694_771e79ab-4ac6-4439-8630-bbf579259fbe 60640-3694 HUMAN PRESCRIPTION DRUG Lollicaine Pina Colada Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Centrix, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 60659-0101_b8cb8d26-d65b-43f8-9418-a48de7e6a62d 60659-0101 HUMAN OTC DRUG Bang Er Jie High-Efficiency Anti-Bacteria Monomer Silver Gel for Women Anti-Bacteria Monomer Silver Gel GEL, DENTIFRICE VAGINAL 20130923 UNAPPROVED HOMEOPATHIC Bang An Bao Medical Equipment Co., Ltd. SILVER 350 ug/3g 60659-0102_f1b663a7-6eed-4cd0-927a-a0cae7bfc629 60659-0102 HUMAN OTC DRUG Bang Er Jie High-Efficiency Anti-Bacteria Monomer Silver -Lotion for Women Anti-Bacteria Monomer Silver Lotion LOTION VAGINAL 20130922 UNAPPROVED HOMEOPATHIC Bang An Bao Medical Equipment Co., Ltd. SILVER 20 mg/200mL 60660-7781_a01ec4f5-30ec-41c1-9ea0-eaa5b301af94 60660-7781 HUMAN OTC DRUG Antiox Calendula officinalis and natrum muriaticum SUPPOSITORY VAGINAL 20090930 UNAPPROVED HOMEOPATHIC Wise Woman Herbals CALENDULA OFFICINALIS FLOWERING TOP; SODIUM CHLORIDE 6; 6 [hp_X]/1; [hp_X]/1 60660-7782_f262aad9-daa3-4099-8b1a-056aa5c03611 60660-7782 HUMAN OTC DRUG Calendula Calendula officinalis SUPPOSITORY RECTAL; VAGINAL 20090619 UNAPPROVED HOMEOPATHIC Wise Woman Herbals CALENDULA OFFICINALIS FLOWERING TOP 6 [hp_X]/1 60660-7783_81a210f5-0917-42a5-a548-2edf1be85b9b 60660-7783 HUMAN OTC DRUG Double T Candida albicans, Thuja occidentalis SUPPOSITORY RECTAL; VAGINAL 20090629 UNAPPROVED HOMEOPATHIC Wise Woman Herbals CANDIDA ALBICANS; THUJA OCCIDENTALIS LEAFY TWIG 6; 6 [hp_C]/1; [hp_X]/1 60660-7784_09fbb116-5d61-47c1-a7ee-c54cf7598b4c 60660-7784 HUMAN OTC DRUG Healing Calendula officinalis, Silacea SUPPOSITORY RECTAL; VAGINAL 20090609 UNAPPROVED HOMEOPATHIC Wise Woman Herbals CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE 6; 10 [hp_X]/1; [hp_X]/1 60660-7785_ef9de637-bd20-45d1-8be5-adb6b79373a3 60660-7785 HUMAN OTC DRUG 1 Echinacea, Hydrastis Canadensis SUPPOSITORY VAGINAL 20090626 UNAPPROVED HOMEOPATHIC Wise Woman Herbals ECHINACEA, UNSPECIFIED; GOLDENSEAL 6; 6 [hp_X]/1; [hp_X]/1 60660-7786_f4201e81-68ed-436e-8013-1c9b56534a4d 60660-7786 HUMAN OTC DRUG 2 Calcarea fluorica, Collinsonia canadensis, Hamamelis virginiana SUPPOSITORY RECTAL; VAGINAL 20090810 UNAPPROVED HOMEOPATHIC Wise Woman Herbals CALCIUM FLUORIDE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 12; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 60660-7787_f8888d47-f0ab-4c4b-8779-0fb740a4a024 60660-7787 HUMAN OTC DRUG Thuja Thuja occidentalis SUPPOSITORY RECTAL; VAGINAL 20091118 UNAPPROVED HOMEOPATHIC Wise Woman Herbals THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 60660-7788_d0742572-a04e-4be4-ba5a-a01bf117e54e 60660-7788 HUMAN OTC DRUG Vag Pack Hydrastis Canadensis SUPPOSITORY VAGINAL 20090717 UNAPPROVED HOMEOPATHIC Wise Woman Herbals GOLDENSEAL 6 [hp_X]/1 60665-001_c35f5cd3-423a-468e-a2f3-374b8528b608 60665-001 HUMAN OTC DRUG Sambrosa Sweet Dreams Nighttime Doxylamine succinate SYRUP ORAL 20140201 OTC MONOGRAPH FINAL part341 Sambrosa Care Inc. DOXYLAMINE SUCCINATE 9.75 mg/5mL 60675-000_ad8d2e1a-4331-4b7d-af00-ad089e8355c8 60675-000 HUMAN OTC DRUG Paris Hand Sanitizer Vanilla Scent ALCOHOL GEL TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part333E Michaels Stores Procurement Company ALCOHOL 620 mg/mL 60675-001_8296ef07-2fa7-4b2e-b066-cf94998c8562 60675-001 HUMAN OTC DRUG Tokyo Hand Sanitizer Vanilla Scent ALCOHOL GEL TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part333E Michaels Stores Procurement Company ALCOHOL 620 mg/mL 60675-002_103d63aa-2be1-4213-a3ca-a6b75ca53d44 60675-002 HUMAN OTC DRUG I LOVE NY Hand Sanitizer Vanilla Scent ALCOHOL GEL TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part333E Michaels Stores Procurement Company ALCOHOL 620 mg/mL 60675-003_06e90964-ee3d-4b3b-8228-ad0b9de22455 60675-003 HUMAN OTC DRUG LONDON Hand Sanitizer Vanilla Scent ALCOHOL GEL TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part333E Michaels Stores Procurement Company ALCOHOL 620 mg/mL 60675-004_998ae417-782e-4802-b6de-4308799742ca 60675-004 HUMAN OTC DRUG Hand Sanitizer Vanilla Scent ALCOHOL GEL TOPICAL 20140924 OTC MONOGRAPH NOT FINAL part333E Michaels Stores Procurement Company ALCOHOL 62 mL/100mL 60681-0011_6c74c6f4-81a4-4421-9a8f-d9dd92065e56 60681-0011 HUMAN OTC DRUG Pleo Stolo penicillium brevicompactum SOLUTION/ DROPS ORAL 20100615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM BREVICOMPACTUM 6 [hp_X]/10mL 60681-0021_15f8962a-0abe-42cf-9766-15d8508ba34d 60681-0021 HUMAN OTC DRUG Pleo Oryzae aspergillus flavus var. oryzae SOLUTION/ DROPS ORAL 20100615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS FLAVUS VAR. ORYZAE 6 [hp_X]/10mL 60681-0031_65b23a17-dfdc-4fe5-86f6-08933ebd6bfa 60681-0031 HUMAN OTC DRUG Pleo Nota-Quent PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM and PENICILLIUM GLABRUM LIQUID ORAL 20120415 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM 5; 5 [hp_X]/mL; [hp_X]/mL 60681-0101_515a3694-0e6f-46ec-a562-5ccaf1638b5a 60681-0101 HUMAN OTC DRUG Pleo Alb candida albicans SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG CANDIDA ALBICANS 5 [HP_X]/10mL 60681-0102_696611f6-3005-4492-81b7-c5a9eaf4c73d 60681-0102 HUMAN OTC DRUG Pleo Alb candida albicans CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA ALBICANS 4 [HP_X]/1 60681-0103_9d8cfc6f-ce07-4da3-9b51-2cceff9115c3 60681-0103 HUMAN OTC DRUG Pleo Alb candida albicans SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA ALBICANS 3 [hp_X]/1 60681-0104_45747833-10f1-4f74-a224-5fcc0badffbb 60681-0104 HUMAN OTC DRUG Pleo Alb candida albicans OINTMENT TOPICAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA ALBICANS 3 [HP_X]/30g 60681-0105_3a681a3a-ed5e-442f-8b25-d1cc4b440298 60681-0105 HUMAN OTC DRUG Pleo Alb candida albicans LIQUID ORAL 20040524 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA ALBICANS 5 [hp_X]/mL 60681-0111_6d9dea98-74a3-4cd0-9b21-7965d526ea31 60681-0111 HUMAN OTC DRUG Pleo Cal GIANT PUFFBALL SOLUTION/ DROPS ORAL 19980819 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG GIANT PUFFBALL 3 [hp_X]/10mL 60681-0113_97db8584-c5e0-4d6b-8435-566f7614a27b 60681-0113 HUMAN OTC DRUG Pleo Cal CALVATIA GIGANTEA WHOLE TABLET ORAL 20120710 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG CALVATIA GIGANTEA WHOLE 4 [hp_X]/1 60681-0114_350040ca-a144-4342-a1e3-c8eef2263434 60681-0114 HUMAN OTC DRUG Pleo Form formic acid SOLUTION/ DROPS ORAL 20041209 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG FORMIC ACID 200 [hp_X]/30mL 60681-0115_b1bf4a34-4d5c-4de2-bdb9-6a8ee5f9bbd6 60681-0115 HUMAN OTC DRUG Pleo Form formic acid KIT 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG 60681-0122_89e189c7-53ee-4cf4-a664-734155a50998 60681-0122 HUMAN OTC DRUG Pleo Grif MAITAKE LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MAITAKE 5 [hp_X]/mL 60681-0123_d4133eec-bf11-4802-a54a-63706c9a3010 60681-0123 HUMAN OTC DRUG Pleo Grif maitake SOLUTION/ DROPS ORAL 19980202 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MAITAKE 5 [hp_X]/10mL 60681-0205_19d5e25c-9ab9-4fec-a990-aad30a93a1da 60681-0205 HUMAN OTC DRUG Pleo Art U Brevibacterium stationis LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BREVIBACTERIUM STATIONIS 6 [hp_X]/mL 60681-0301_624cbab3-3afb-43b0-b339-ce0c47f08728 60681-0301 HUMAN OTC DRUG Pleo Art A propionibacterium acnes SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PROPIONIBACTERIUM ACNES 6 [hp_X]/10mL 60681-0302_75f7995f-d855-4908-92e4-3bef0c831180 60681-0302 HUMAN OTC DRUG Pleo Art A propionibacterium acnes LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PROPIONIBACTERIUM ACNES 6 [hp_X]/mL 60681-0401_af3ada15-2db9-4843-9f44-5ab428ac87aa 60681-0401 HUMAN OTC DRUG Pleo Art U Brevibacterium stationis SOLUTION/ DROPS ORAL 19970219 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BREVIBACTERIUM STATIONIS 6 [hp_X]/10mL 60681-0801_d0e7d190-9165-4804-ae04-6578b13cb664 60681-0801 HUMAN OTC DRUG Pleo Muscar AMANITA MUSCARIA WHOLE LIQUID ORAL 20120710 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG AMANITA MUSCARIA WHOLE 6 [hp_X]/10mL 60681-0802_c29f15a9-6aa5-4dba-9616-2d0540131b27 60681-0802 HUMAN OTC DRUG Pleo Muscar amanita muscaria var. muscaria LIQUID ORAL 20100615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG AMANITA MUSCARIA VAR. MUSCARIA 6 [hp_X]/mL 60681-0901_73b79917-67b8-4112-9eec-02adbc2e6e18 60681-0901 HUMAN OTC DRUG Pleo Selene sodium selenite SOLUTION/ DROPS ORAL 20100615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SODIUM SELENITE 4 [hp_X]/30mL 60681-1001_0f11b256-9f93-4f77-87e8-a8bab35dd15b 60681-1001 HUMAN OTC DRUG Pleo Ex candida albicans, candida parapsilosis and penicillium roqueforti SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; PENICILLIUM ROQUEFORTI 3; 3; 3 [HP_X]/1; [HP_X]/1; [HP_X]/1 60681-1002_c49f549d-6bcf-4e32-a2af-f4fa2748fbd6 60681-1002 HUMAN OTC DRUG Pleo San Ger Germanium Citrate Lactate SOLUTION/ DROPS ORAL 19990519 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG GERMANIUM CITRATE LACTATE 6 [hp_X]/100mL 60681-1003_5ac916ec-8252-4e53-8009-3cfb42347074 60681-1003 HUMAN OTC DRUG Pleo Ex candida albicans, candida parapsilosis, and penicillium roqueforti SOLUTION/ DROPS ORAL 20100615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; PENICILLIUM ROQUEFORTI 5; 5; 5 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 60681-1005_612a8a21-a97d-4900-8cca-1a406eec738b 60681-1005 HUMAN OTC DRUG Pleo Ex candida albicans, candida parapsilosis and penicillium roqueforti LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; PENICILLIUM ROQUEFORTI 5; 5; 5 [HP_X]/mL; [HP_X]/mL; [HP_X]/mL 60681-1071_dd9ad819-83d7-4c8c-af00-e200f2873adf 60681-1071 HUMAN OTC DRUG Pleo Cup copper gluconate SOLUTION/ DROPS ORAL 19980812 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG COPPER GLUCONATE 3 [hp_X]/30mL 60681-1075_701aec1f-7638-4005-bd5a-9f16bf00e75b 60681-1075 HUMAN OTC DRUG Pleo Cup copper gluconate LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG COPPER GLUCONATE 4 [hp_X]/2mL 60681-1086_cbf8a5ca-4a01-4d24-8224-822f91db8de6 60681-1086 HUMAN OTC DRUG Pleo Chrys human placenta hydrolysate LIQUID ORAL 20041015 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG HUMAN PLACENTA HYDROLYSATE 5 [hp_X]/2mL 60681-1101_f9c345ae-2c9b-4df3-9395-9ccbb8f02184 60681-1101 HUMAN OTC DRUG Pleo Fort penicillium roqueforti SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG PENICILLIUM ROQUEFORTI 5 [HP_X]/10mL 60681-1102_db6d1eaf-225e-4b82-b7b4-18ddcae52553 60681-1102 HUMAN OTC DRUG Pleo Fort penicillium roqueforti TABLET ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM ROQUEFORTI 5 [HP_X]/1 60681-1103_f0dbce71-9e88-4c14-b19e-0af1b7c82556 60681-1103 HUMAN OTC DRUG Pleo Fort penicillium roqueforti CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM ROQUEFORTI 4 [HP_X]/1 60681-1105_5966a4c4-a4ac-4cf6-a9e9-5e6dc9067c3f 60681-1105 HUMAN OTC DRUG Pleo Fort penicillium roqueforti LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM ROQUEFORTI 5 [hp_X]/mL 60681-1106_99695141-20c2-4530-b3fb-66072a0860d9 60681-1106 HUMAN OTC DRUG Pleo Fort penicillium roqueforti SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM ROQUEFORTI 3 [hp_X]/1 60681-1204_640c82c3-ca2b-4d63-a24b-9e5a222a5a76 60681-1204 HUMAN OTC DRUG Pleo San MYC mycobacterium bovis SOLUTION/ DROPS ORAL 19970919 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM BOVIS 6 [hp_X]/10mL 60681-1205_51ecc515-85cb-48d4-a2bc-c175d4949fc6 60681-1205 HUMAN OTC DRUG Pleo San Myc mycobacterium bovis LIQUID ORAL 20040421 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM BOVIS 5 [hp_X]/mL 60681-1214_78385436-734d-4422-b69d-c86d63062314 60681-1214 HUMAN OTC DRUG Pleo San Klebs klebsiella pneumoniae SOLUTION/ DROPS ORAL 19970730 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG KLEBSIELLA PNEUMONIAE 6 [HP_X]/10mL 60681-1215_46f126fd-f60c-497a-850e-ab11c4bc2a8e 60681-1215 HUMAN OTC DRUG Pleo San Klebs klebsiella pneumoniae LIQUID ORAL 20051101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG KLEBSIELLA PNEUMONIAE 6 [hp_X]/mL 60681-1224_9c1c2e3d-614d-4e8e-97be-a8767c140297 60681-1224 HUMAN OTC DRUG Pleo San Coli escherichia coli SOLUTION/ DROPS ORAL 19970919 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ESCHERICHIA COLI 6 [HP_X]/10mL 60681-1225_33cbf028-2354-455e-94c5-eb7cd490531b 60681-1225 HUMAN OTC DRUG Pleo San Coli escherichia coli LIQUID ORAL 20040524 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ESCHERICHIA COLI 7 [hp_X]/mL 60681-1234_3f999fba-9d76-4f5b-a0e9-bd396a0ced24 60681-1234 HUMAN OTC DRUG Pleo San Brucel brucella melitensis SOLUTION/ DROPS ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BRUCELLA MELITENSIS 6 [HP_X]/10mL 60681-1235_39d6abf5-44e9-4342-bf81-b0c106527d0b 60681-1235 HUMAN OTC DRUG Pleo San Brucel brucella melitensis LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BRUCELLA MELITENSIS 6 [hp_X]/mL 60681-1244_95351bd8-45c3-4a41-97ff-20345278b7a6 60681-1244 HUMAN OTC DRUG Pleo San Prot proteus vulgaris SOLUTION/ DROPS ORAL 19970919 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PROTEUS VULGARIS 6 [hp_X]/10mL 60681-1245_56d99164-317a-44ff-9909-d7a2c8fcf604 60681-1245 HUMAN OTC DRUG Pleo San Prot proteus vulgaris LIQUID ORAL 20060101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PROTEUS VULGARIS 7 [hp_X]/mL 60681-1254_e15e1d5f-113a-4099-8aac-4341fe33b520 60681-1254 HUMAN OTC DRUG Pleo San Pseu pseudomonas aeruginosa SOLUTION/ DROPS ORAL 19970730 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PSEUDOMONAS AERUGINOSA 6 [hp_X]/10mL 60681-1256_38cdb649-cbf4-4ae2-985a-62212d840fea 60681-1256 HUMAN OTC DRUG Pleo San Pseu pseudomonas aeruginosa LIQUID ORAL 20091201 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PSEUDOMONAS AERUGINOSA 6 [hp_X]/mL 60681-1264_47d611f2-e495-4774-b0b3-acd9dd826a8f 60681-1264 HUMAN OTC DRUG Pleo San Salm salmonella enterica subsp. enterica serovar enteritidis SOLUTION/ DROPS ORAL 19970919 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 6 [hp_X]/10mL 60681-1265_59be4fd4-ebd5-40d4-ba1a-49d3df58706a 60681-1265 HUMAN OTC DRUG Pleo San Salm salmonella enterica subsp. enterica serovar enteritidis LIQUID ORAL 20070430 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 6 [hp_X]/mL 60681-1274_8aef1a1a-b23c-4434-adf9-75f7ce257ac3 60681-1274 HUMAN OTC DRUG Pleo San Serra serratia marcescens SOLUTION/ DROPS ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SERRATIA MARCESCENS 6 [HP_X]/10mL 60681-1277_06169499-fd43-47ea-883c-0d6a9dc5b602 60681-1277 HUMAN OTC DRUG Pleo San Serra serratia marcescens LIQUID ORAL 20091201 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SERRATIA MARCESCENS 7 [hp_X]/mL 60681-1284_c773add7-9d3c-4637-9e5d-650d15149748 60681-1284 HUMAN OTC DRUG Pleo San Staph staphylococcus aureus SOLUTION/ DROPS ORAL 19970919 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG STAPHYLOCOCCUS AUREUS 6 [hp_X]/10mL 60681-1285_7b5b993d-1e4c-4e03-b878-691cc6c07b52 60681-1285 HUMAN OTC DRUG Pleo San Staph staphylococcus aureus LIQUID ORAL 20061130 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG STAPHYLOCOCCUS AUREUS 5 [hp_X]/mL 60681-1294_93f69ba0-f484-499c-bdba-f2470253f665 60681-1294 HUMAN OTC DRUG Pleo San Strep streptococcus pyogenes SOLUTION/ DROPS ORAL 19970919 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG STREPTOCOCCUS PYOGENES 6 [hp_X]/10mL 60681-1295_bb24bd43-73db-4527-aa07-77433cff749d 60681-1295 HUMAN OTC DRUG Pleo San Strep streptococcus pyogenes LIQUID ORAL 19970430 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG STREPTOCOCCUS PYOGENES 5 [hp_X]/mL 60681-1301_47f56433-ea33-4cb6-b6fd-8283d2302936 60681-1301 HUMAN OTC DRUG Pleo Lari laricifomes officinalis fruiting body SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG LARICIFOMES OFFICINALIS FRUITING BODY 5 [hp_X]/10mL 60681-1302_1fe09bca-eab8-4547-83f2-f6dd80fc6494 60681-1302 HUMAN OTC DRUG Pleo Lari laricifomes officinalis fruiting body CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG LARICIFOMES OFFICINALIS FRUITING BODY 4 [hp_X]/1 60681-1303_69bc6646-2db4-4d93-a009-4adb904c87cb 60681-1303 HUMAN OTC DRUG Pleo Lari laricifomes officinalis fruiting body LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG LARICIFOMES OFFICINALIS FRUITING BODY 5 [hp_X]/mL 60681-1304_62dda172-b7ba-4642-8444-1a8c49e64e06 60681-1304 HUMAN OTC DRUG Pleo San Trich Trichophyton Verrucosum SOLUTION/ DROPS ORAL 19970919 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG TRICHOPHYTON VERRUCOSUM 6 [hp_X]/10mL 60681-1305_7d75e786-dfd3-427b-b61e-e0153fd52737 60681-1305 HUMAN OTC DRUG Pleo San Trich Trichophyton Verrucosum LIQUID ORAL 19970430 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG TRICHOPHYTON VERRUCOSUM 5 [hp_X]/mL 60681-1311_add41509-5db5-4ee1-a7d9-9718a6a389b4 60681-1311 HUMAN OTC DRUG Pleo Spermus Manuka Oil SOLUTION/ DROPS ORAL 20060101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MANUKA OIL 1 [hp_X]/30mL 60681-1315_766f3cbf-0121-435e-8e23-da4625399111 60681-1315 HUMAN OTC DRUG Pleo San Cand candida albicans LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA ALBICANS 5 [hp_X]/mL 60681-1316_3e382f17-20e5-4eb7-b6a3-8e4915220aea 60681-1316 HUMAN OTC DRUG Pleo San Cand candida albicans SOLUTION/ DROPS ORAL 19970901 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG CANDIDA ALBICANS 6 [hp_X]/10mL 60681-1401_18279799-5076-4ae7-be08-f334fc893cd0 60681-1401 HUMAN OTC DRUG Pleo Lat BACILLUS CEREUS SOLUTION/ DROPS ORAL 19961213 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS CEREUS 6 [hp_X]/5mL 60681-1402_164e5b41-df7b-4e73-aa04-b72762e6f8b4 60681-1402 HUMAN OTC DRUG Pleo Lat bacillus cereus CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS CEREUS 4 [HP_X]/1 60681-1403_80f10916-4b22-4ac3-944f-216b8ecccc76 60681-1403 HUMAN OTC DRUG Pleo Lat bacillus cereus CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS CEREUS 6 [HP_X]/1 60681-1404_95ac6a55-6785-4933-8101-131648e12413 60681-1404 HUMAN OTC DRUG Pleo Lat bacillus cereus SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS CEREUS 6 [hp_X]/1 60681-1405_27fa14da-5e6a-49c1-8e51-04ee1e20ce36 60681-1405 HUMAN OTC DRUG Pleo Lat bacillus cereus LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS CEREUS 6 [hp_X]/mL 60681-1407_7e186d46-00cd-4888-ba62-35ddf1ed016b 60681-1407 HUMAN OTC DRUG Pleo Lat bacillus cereus LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS CEREUS 4 [hp_X]/mL 60681-1601_60d43733-b29f-4dae-915e-a608e89aa2ae 60681-1601 HUMAN OTC DRUG Pleo Leptu propionibacterium avidum CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PROPIONIBACTERIUM AVIDUM 6 [HP_X]/1 60681-1602_f2bee966-9d17-4bcf-93f7-b7522beddc15 60681-1602 HUMAN OTC DRUG Pleo Leptu propionibacterium avidum SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PROPIONIBACTERIUM AVIDUM 6 [HP_X]/1 60681-1701_7fd93bd9-9d01-4bb4-b664-044eccdea2c8 60681-1701 HUMAN OTC DRUG Pleo Mucedo RHIZOPUS STOLONIFER SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG RHIZOPUS STOLONIFER 5 [HP_X]/10mL 60681-1702_a0628534-2d41-4d9f-92c2-34a32eb7583c 60681-1702 HUMAN OTC DRUG Pleo Mucedo rhizopus stolonifer CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG RHIZOPUS STOLONIFER 4 [HP_X]/1 60681-1703_f1336af0-a1cc-413d-95b8-8a86c40b8412 60681-1703 HUMAN OTC DRUG Pleo Mucedo rhizopus stolonifer SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG RHIZOPUS STOLONIFER 3 [HP_X]/1 60681-1704_32e6a14b-d9c7-4aee-9102-983aec01f7b6 60681-1704 HUMAN OTC DRUG Pleo Mucedo rhizopus stolonifer LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG RHIZOPUS STOLONIFER 5 [hp_X]/mL 60681-1801_5c32e3e8-2f06-4581-a6a3-242114090ffe 60681-1801 HUMAN OTC DRUG Pleo Muc mucor racemosus SOLUTION/ DROPS ORAL 19960209 UNAPPROVED HOMEOPATHIC SANUM-KEHLBECK GMBH & CO KG MUCOR RACEMOSUS 5 [HP_X]/10mL 60681-1802_9c286f03-fd08-486f-9e2b-96e8208cc927 60681-1802 HUMAN OTC DRUG Pleo Muc mucor racemosus SOLUTION/ DROPS OPHTHALMIC 19960309 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS 5 [hp_X]/5mL 60681-1803_e001193f-7430-4f1f-93bc-6d1b65c3b44f 60681-1803 HUMAN OTC DRUG Pleo Muc mucor racemosus TABLET ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS 5 [HP_X]/1 60681-1804_edba6598-8a27-497b-9cf4-7ba82006f73e 60681-1804 HUMAN OTC DRUG Pleo Muc mucor racemosus CAPSULE ORAL 19960301 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS 4 [HP_X]/1 60681-1805_d46d19b4-989a-434a-a7ee-700511a7d07d 60681-1805 HUMAN OTC DRUG Pleo Muc mucor racemosus SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS 3 [hp_X]/1 60681-1806_908ba301-8281-4f4e-9209-84e904c911cf 60681-1806 HUMAN OTC DRUG Pleo Muc mucor racemosus OINTMENT TOPICAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS 3 [hp_X]/30g 60681-1807_b3c388cb-fb2d-4be0-bbeb-4212ce2f672f 60681-1807 HUMAN OTC DRUG Pleo Muc mucor racemosus LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS 5 [hp_X]/mL 60681-1808_a8a79364-5ca1-4a76-af1c-25db78dc6e39 60681-1808 HUMAN OTC DRUG Pleo Muc mucor racemosus LIQUID ORAL 19980101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS 7 [hp_X]/mL 60681-1809_b343d7d4-238f-4c26-a7a0-d7e1609f3bb1 60681-1809 HUMAN OTC DRUG Pleo Muc mucor racemosus LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS 6 [hp_X]/mL 60681-1822_dea129c9-a1e4-447f-99c5-d87c4f19fc32 60681-1822 HUMAN OTC DRUG Pleo Muc mucor racemosus LIQUID OPHTHALMIC 20110615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co KG MUCOR RACEMOSUS 5 [hp_X]/mL 60681-1901_9a7fff02-125c-461e-a93a-f745a2383298 60681-1901 HUMAN OTC DRUG Pleo Muc Ex Mucor racemosus immunoserum rabbit SOLUTION/ DROPS ORAL 19980812 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS IMMUNOSERUM RABBIT 6 [hp_X]/10mL 60681-1905_5a555ef5-4cc2-434f-8370-0c50df2202de 60681-1905 HUMAN OTC DRUG Pleo Muc Ex Mucor racemosus immunoserum rabbit LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS IMMUNOSERUM RABBIT 6 [hp_X]/mL 60681-2101_f6b1a16f-a6d4-4084-8fb9-8dc6ad956722 60681-2101 HUMAN OTC DRUG Pleo Nig aspergillus niger var. niger SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER VAR. NIGER 5 [HP_X]/10mL 60681-2102_e5c16ad8-763d-4887-b2fd-e6e97f53fd23 60681-2102 HUMAN OTC DRUG Pleo Nig aspergillus niger var. niger TABLET ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER VAR. NIGER 5 [HP_X]/1 60681-2103_f9361bb9-2c5a-4983-8d8b-0ace0b71031b 60681-2103 HUMAN OTC DRUG Pleo Nig aspergillus niger var. niger CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER VAR. NIGER 4 [HP_X]/1 60681-2104_ea9a4acb-8ae4-4012-8be8-eb067e10e957 60681-2104 HUMAN OTC DRUG Pleo Nig Aspergillus Niger Var. Niger SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER VAR. NIGER 3 [hp_X]/1 60681-2105_0e57719d-2c7e-4083-9c03-09246aaea7be 60681-2105 HUMAN OTC DRUG Pleo Nig aspergillus niger SOLUTION/ DROPS ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER 5 [hp_X]/mL 60681-2106_c61152e0-1aad-4d81-9436-07ab4185a9cc 60681-2106 HUMAN OTC DRUG Pleo Nig aspergillus niger var. niger SOLUTION/ DROPS ORAL 20040421 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER VAR. NIGER 7 [HP_X]/mL 60681-2107_59218acd-3120-4361-9da6-1380a371c9fb 60681-2107 HUMAN OTC DRUG Pleo Nig aspergillus niger var. niger SOLUTION/ DROPS ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER VAR. NIGER 6 [HP_X]/mL 60681-2111_51b47753-af68-46bb-a361-6141c1c28f4a 60681-2111 HUMAN OTC DRUG Pleo Nig Ex Aspergillus niger immunoserum rabbit LIQUID ORAL 19980819 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER IMMUNOSERUM RABBIT 6 [hp_X]/mL 60681-2112_a5d3a0a6-6692-4ef6-b1ce-d987e9e3909c 60681-2112 HUMAN OTC DRUG Pleo Nig Ex Aspergillus niger immunoserum rabbit SOLUTION/ DROPS ORAL 19980812 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER IMMUNOSERUM RABBIT 6 [hp_X]/10mL 60681-2301_790689dc-0b81-4d64-9753-d5609c7cc385 60681-2301 HUMAN OTC DRUG Pleo Not penicillium chrysogenum var. chrysogenum SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 5 [HP_X]/10mL 60681-2302_69e09f1a-fb20-46c5-a5a9-b941c6b815b5 60681-2302 HUMAN OTC DRUG Pleo Not penicillium chrysogenum var. chrysogenum TABLET ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 5 [HP_X]/1 60681-2303_c5b2c58c-7ab5-4772-a9a7-f9012806e279 60681-2303 HUMAN OTC DRUG Pleo Not penicillium chrysogenum var. chrysogenum CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 4 [HP_X]/1 60681-2304_b97961d7-1849-4092-965a-55bc4b42e6c7 60681-2304 HUMAN OTC DRUG Pleo Not penicillium chrysogenum var. chrysogenum SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 3 [hp_X]/1 60681-2305_82d417ae-9374-45b4-943f-3d4991b346d0 60681-2305 HUMAN OTC DRUG Pleo Not penicillium chrysogenum var. chrysogenum OINTMENT TOPICAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 3 [HP_X]/30g 60681-2306_4744f01c-ed90-420d-9272-559f823636e7 60681-2306 HUMAN OTC DRUG Pleo Not penicillium chrysogenum var. chrysogenum LIQUID ORAL 20051101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 5 [hp_X]/mL 60681-2308_78c3cf26-27fc-4a92-8a2f-404fd6a37e35 60681-2308 HUMAN OTC DRUG Pleo Not penicillium chrysogenum var. chrysogenum LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 6 [hp_X]/mL 60681-2310_40220dfc-2900-4224-85d5-c3e716fe188f 60681-2310 HUMAN OTC DRUG Pleo Not penicillium chrysogenum var. chrysogenum LIQUID ORAL 19971219 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 7 [hp_X]/mL 60681-2401_1bdccfcb-ad36-4760-a746-c699b708a215 60681-2401 HUMAN OTC DRUG Pleo Oku OKOUBAKA AUBREVILLEI BARK SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG OKOUBAKA AUBREVILLEI BARK 2 [hp_X]/30mL 60681-2402_47621cb8-49dd-48fe-84a1-6be6402f2fc3 60681-2402 HUMAN OTC DRUG Pleo Oku OKOUBAKA AUBREVILLEI BARK TABLET ORAL 20120710 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG OKOUBAKA AUBREVILLEI BARK 2 [hp_X]/1 60681-2501_a0bab26f-0b21-41dd-87c9-727e6a675f8c 60681-2501 HUMAN OTC DRUG Pleo Pef CANDIDA PARAPSILOSIS SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA PARAPSILOSIS 5 [HP_X]/10mL 60681-2502_1277da1b-6e57-4a62-ab00-cef349fc6b52 60681-2502 HUMAN OTC DRUG Pleo Pef candida parapsilosis CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA PARAPSILOSIS 4 [HP_X]/1 60681-2503_d6dcb2c9-a51b-4f9d-8dbb-aa9e08fdbdd9 60681-2503 HUMAN OTC DRUG Pleo Pef candida parapsilosis SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA PARAPSILOSIS 3 [hp_X]/1 60681-2504_d7527fc7-f0a8-45a0-bd7f-153919514458 60681-2504 HUMAN OTC DRUG Pleo Pef candida parapsilosis OINTMENT TOPICAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA PARAPSILOSIS 3 [HP_X]/30g 60681-2505_88ceb47a-16f4-4ce3-b739-1e1e4b29af4e 60681-2505 HUMAN OTC DRUG Pleo Pef candida parapsilosis LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA PARAPSILOSIS 6 [hp_X]/mL 60681-2701_d9b525db-096b-443b-b3c7-4353c8cf67b0 60681-2701 HUMAN OTC DRUG Pleo Pin FOMITOPSIS PINICOLA SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG FOMITOPSIS PINICOLA 5 [HP_X]/10mL 60681-2702_71ade6c3-2937-47a6-a921-17804fcb20a8 60681-2702 HUMAN OTC DRUG Pleo Pin fomitopsis pinicola CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG FOMITOPSIS PINICOLA 4 [HP_X]/1 60681-2703_d555121b-fdd5-4098-8d79-2b3a9df3575d 60681-2703 HUMAN OTC DRUG Pleo Pin fomitopsis pinicola SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG FOMITOPSIS PINICOLA 4 [hp_X]/1 60681-2705_ffd0f45c-90f2-486c-820c-f2cd83d52544 60681-2705 HUMAN OTC DRUG Pleo Pin fomitopsis pinicola fruiting body LIQUID ORAL 19971219 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG FOMITOPSIS PINICOLA FRUITING BODY 5 [hp_X]/mL 60681-2801_9d56e0a0-65ba-48cf-b473-419f10f342ae 60681-2801 HUMAN OTC DRUG Pleo Poly A mycobacterium bovis immunoserum rabbit and mycobacterium microti immunoserum rabbit SOLUTION/ DROPS TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM BOVIS IMMUNOSERUM RABBIT; MYCOBACTERIUM MICROTI IMMUNOSERUM RABBIT 9; 9 [hp_X]/10mL; [hp_X]/10mL 60681-2802_5fbbdfd8-6337-43b8-94ed-34651e29721b 60681-2802 HUMAN OTC DRUG Pleo Poly D lactococcus lactis immunoserum rabbit, streptococcus pyogenes immunoserum rabbit, streptococcus viridans group immunoserum rabbit, staphylococcus epidermidis immunoserum rabbit, staphylococcus aureus SOLUTION/ DROPS TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG LACTOCOCCUS LACTIS IMMUNOSERUM RABBIT; MYCOBACTERIUM BOVIS IMMUNOSERUM RABBIT; STAPHYLOCOCCUS AUREUS IMMUNOSERUM RABBIT; STAPHYLOCOCCUS EPIDERMIDIS IMMUNOSERUM RABBIT; STREPTOCOCCUS PNEUMONIAE IMMUNOSERUM RABBIT; STREPTOCOCCUS PYOGENES IMMUNOSERUM RABBIT; STREPTOCOCCUS VIRIDANS GROUP IMMUNOSERUM RABBIT 9; 9; 9; 9; 9; 9; 9 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 60681-2803_8941d7e0-ce8f-47fe-ba0b-f53fcc3d86f9 60681-2803 HUMAN OTC DRUG Pleo Poly Dx streptococcus pneumoniae immunoserum rabbit and staphylococcus aureus immunoserum rabbit SOLUTION/ DROPS TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG STAPHYLOCOCCUS AUREUS IMMUNOSERUM RABBIT; STREPTOCOCCUS PNEUMONIAE IMMUNOSERUM RABBIT 9; 9 [hp_X]/10mL; [hp_X]/10mL 60681-2804_89d0830d-c768-4526-a4ae-7654c9e00cb6 60681-2804 HUMAN OTC DRUG Pleo Poly E treponema pallidum immunoserum rabbit SOLUTION/ DROPS TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG TREPONEMA PALLIDUM IMMUNOSERUM RABBIT 9 [hp_X]/10mL 60681-2805_8db3ba35-4cb4-4742-a2cd-3075409cd0fb 60681-2805 HUMAN OTC DRUG Pleo Poly G influenza A/B virus immunoserum rabbit, haemophilus influenzae immunoserum rabbit, and klebsiella pneumoniae SOLUTION/ DROPS TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG HAEMOPHILUS INFLUENZAE IMMUNOSERUM RABBIT; INFLUENZA A/B VIRUS IMMUNOSERUM RABBIT; KLEBSIELLA PNEUMONIAE 9; 9; 9 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 60681-2806_72546726-32dc-4626-955a-2d873310d75b 60681-2806 HUMAN OTC DRUG Pleo Poly K streptococcus pneumoniae immunoserum rabbit and staphylococcus aureus immunoserum rabbit SOLUTION/ DROPS TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG STAPHYLOCOCCUS AUREUS IMMUNOSERUM RABBIT; STREPTOCOCCUS PNEUMONIAE IMMUNOSERUM RABBIT 9; 9 [hp_X]/10mL; [hp_X]/10mL 60681-2807_d32bec3f-e6e0-4a91-9996-536c40566c14 60681-2807 HUMAN OTC DRUG Pleo Poly M malarial plasmodium group immunoserum rabbit OINTMENT TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MALARIAL PLASMODIUM GROUP IMMUNOSERUM RABBIT 9 [hp_X]/10mL 60681-2808_bb2c59f0-e661-46e7-a137-09cee6b48b50 60681-2808 HUMAN OTC DRUG Pleo Poly Om lactococcus lactis immunoserum rabbit, streptococcus pyogenes immunoserum rabbit, streptococcus viridans group immunoserum rabbit, staphylococcus epidermidis immunoserum rabbit, staphylococcus aureus SOLUTION/ DROPS TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG LACTOCOCCUS LACTIS IMMUNOSERUM RABBIT; MYCOBACTERIUM BOVIS IMMUNOSERUM RABBIT; STAPHYLOCOCCUS AUREUS IMMUNOSERUM RABBIT; STAPHYLOCOCCUS EPIDERMIDIS IMMUNOSERUM RABBIT; STREPTOCOCCUS PNEUMONIAE IMMUNOSERUM RABBIT; STREPTOCOCCUS PYOGENES IMMUNOSERUM RABBIT; STREPTOCOCCUS VIRIDANS GROUP IMMUNOSERUM RABBIT 9; 9; 9; 9; 9; 9; 9 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 60681-2809_3ca665c4-c93c-4903-8223-f2bfc6cf9a23 60681-2809 HUMAN OTC DRUG Pleo Poly R mycobacterium bovis immunoserum rabbit, mycobacterium microti immunoserum rabbit, and streptococcus pyogenes immunoserum rabbit LIQUID TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM BOVIS IMMUNOSERUM RABBIT; MYCOBACTERIUM MICROTI IMMUNOSERUM RABBIT; STREPTOCOCCUS PYOGENES IMMUNOSERUM RABBIT 9; 9; 9 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 60681-2810_b177c431-160e-49b0-a794-8ed80387d88e 60681-2810 HUMAN OTC DRUG Pleo Poly T mycobacterium microti immunoserum rabbit, mycobacterium bovis immunoserum rabbit, and streptococcus pyogenes immunoserum rabbit LIQUID TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM BOVIS IMMUNOSERUM RABBIT; MYCOBACTERIUM MICROTI IMMUNOSERUM RABBIT; STREPTOCOCCUS PYOGENES IMMUNOSERUM RABBIT 9; 9; 9 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL 60681-2901_334e76ae-5c1e-42fd-a383-8b07320b1986 60681-2901 HUMAN OTC DRUG Pleo Quent PENICILLIUM GLABRUM SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM GLABRUM 5 [hp_X]/10mL 60681-2902_ef5f8d62-eb6b-4302-8168-6792719cb163 60681-2902 HUMAN OTC DRUG Pleo Quent penicillium glabrum CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM GLABRUM 4 [hp_X]/1 60681-2904_a02241e3-98bd-4ab6-9a22-3d3f9674d2a3 60681-2904 HUMAN OTC DRUG Pleo Quent penicillium glabrum SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM GLABRUM 3 [HP_X]/1 60681-2905_21fa85bd-7917-4be2-9a2b-df795c9b8146 60681-2905 HUMAN OTC DRUG Pleo Quent PENICILLIUM GLABRUM LIQUID ORAL 19971219 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM GLABRUM 5 [hp_X]/mL 60681-3001_2f76a543-9e89-4de3-9ebd-642bb4504030 60681-3001 HUMAN OTC DRUG Pleo Reb sus scrofa small intestine mucosa lymph follicle CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE 4 [hp_X]/1 60681-3003_97d33857-345d-47e8-b89b-ed24afdabd9e 60681-3003 HUMAN OTC DRUG Pleo Reb sus scrofa small intestine mucosa lymph follicle SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE 4 [hp_X]/1 60681-3006_7b2a6c35-b60b-406c-9714-a040b776dea5 60681-3006 HUMAN OTC DRUG Pleo Reb sus scrofa small intestine mucosa lymph follicle LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE 5 [hp_X]/2mL 60681-3007_65e3613f-918d-4822-89d1-68c67c3bc141 60681-3007 HUMAN OTC DRUG Pleo Reb sus scrofa small intestine mucosa lymph follicle LIQUID ORAL 20060101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE 12 [hp_X]/2mL 60681-3101_710a9906-e7bb-49e1-986e-a15eff2bf99a 60681-3101 HUMAN OTC DRUG Pleo Rec BACILLUS FIRMUS SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS FIRMUS 6 [hp_X]/5mL 60681-3102_9f7f68c3-e9ba-4930-85cc-01d791eda926 60681-3102 HUMAN OTC DRUG Pleo Rec bacillus firmus CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS FIRMUS 4 [hp_X]/1 60681-3103_f9ef983c-4e25-4d35-a3e2-9ca6d213c52a 60681-3103 HUMAN OTC DRUG Pleo Rec bacillus firmus CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS FIRMUS 6 [hp_X]/1 60681-3104_d566ad23-78f0-417c-979e-909c9d9e5f9f 60681-3104 HUMAN OTC DRUG Pleo Rec bacillus firmus SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS FIRMUS 6 [HP_X]/1 60681-3105_7ba62913-b6ac-47d9-8dd8-1ae54a7f1a36 60681-3105 HUMAN OTC DRUG Pleo Rec bacillus firmus LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS FIRMUS 4 [hp_X]/mL 60681-3301_995e1a1d-304a-44f0-875a-6c02fc15a38f 60681-3301 HUMAN OTC DRUG Pleo Rub aspergillus ruber SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS RUBER 5 [hp_X]/10mL 60681-3302_5b83fa1f-c026-4955-9112-fb7b36881714 60681-3302 HUMAN OTC DRUG Pleo Rub aspergillus ruber SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS RUBER 3 [HP_X]/1 60681-3303_23fbff25-a8d6-4d31-82a6-440a89f227f9 60681-3303 HUMAN OTC DRUG Pleo Rub aspergillus ruber LIQUID ORAL 20060101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS RUBER 5 [hp_X]/mL 60681-3401_1003de98-96f7-4640-964f-97f8bb0eab2d 60681-3401 HUMAN OTC DRUG Pleo Sancom mucor racemosus and aspergillus niger var. niger SOLUTION/ DROPS ORAL 19961219 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER VAR. NIGER; MUCOR RACEMOSUS 5; 5 [hp_X]/10mL; [hp_X]/10mL 60681-3601_cb472270-9e6f-49a8-b63b-ea0c803b2092 60681-3601 HUMAN OTC DRUG Pleo San Acne propionibacterium acnes SOLUTION/ DROPS ORAL 19961219 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PROPIONIBACTERIUM ACNES 6 [hp_X]/10mL 60681-3602_59c46a55-feb4-4fa1-acb6-a8d39eb9b980 60681-3602 HUMAN OTC DRUG Pleo San Acne propionibacterium acnes LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PROPIONIBACTERIUM ACNES 5 [hp_X]/mL 60681-3701_4082ceca-f55c-454a-bd38-7b87c65b3e4c 60681-3701 HUMAN OTC DRUG Pleo Rec bacillus firmus LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS FIRMUS 6 [hp_X]/mL 60681-5002_2b04f958-b5a3-4e9a-9396-59b02bb35251 60681-5002 HUMAN OTC DRUG PLEO THYM BOS TAURUS THYMUS SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BOS TAURUS THYMUS 6 [hp_X]/1 60681-5005_1d169fbe-e86f-430a-8ddc-ed4099dc6d6b 60681-5005 HUMAN OTC DRUG Pleo Thym BOS TAURUS THYMUS LIQUID ORAL 19980420 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BOS TAURUS THYMUS 6 [hp_X]/2mL 60681-5101_b17a42a5-eff5-4604-8b6a-69459cc8d4b3 60681-5101 HUMAN OTC DRUG Pleo Usnea usnea barbata SOLUTION/ DROPS ORAL 19961213 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG USNEA BARBATA 1 [HP_X]/30mL 60681-5200_fa7969df-572f-47f2-a670-0ca180d5d829 60681-5200 HUMAN OTC DRUG Pleo Thym thymus extract CAPSULE ORAL 19961213 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG THYMUS EXTRACT 6 [HP_X]/1 60681-5301_f8f9ef39-0eb5-4596-bd05-4b8b37facc3b 60681-5301 HUMAN OTC DRUG Pleo Ut bacillus subtilis SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS SUBTILIS 6 [hp_X]/5mL 60681-5302_8c87f0eb-b4a4-4ae4-965e-07b2280907d9 60681-5302 HUMAN OTC DRUG Pleo Ut bacillus subtilis CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS SUBTILIS 4 [hp_X]/1 60681-5303_a4a1b886-1f1a-4970-962e-bc9588708586 60681-5303 HUMAN OTC DRUG Pleo Ut bacillus subtilis CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS SUBTILIS 6 [hp_X]/1 60681-5304_de7c7e2b-ca7c-47a5-970a-d0cbb015252c 60681-5304 HUMAN OTC DRUG Pleo Ut bacillus subtilis SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS SUBTILIS 6 [HP_X]/1 60681-5305_a6948542-9728-45e9-b95f-ec8f0fef40dd 60681-5305 HUMAN OTC DRUG Pleo Ut bacillus subtilis LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS SUBTILIS 4 [hp_X]/mL 60681-5307_eb145c0d-3ef3-4b61-8343-069514aba01c 60681-5307 HUMAN OTC DRUG Pleo Ut bacillus subtilis LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS SUBTILIS 6 [hp_X]/mL 60681-5401_4e8630e4-ed27-41fa-a0a9-a4c9b844caaf 60681-5401 HUMAN OTC DRUG Pleo Ut S mycobacterium phlei SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM PHLEI 6 [hp_X]/5mL 60681-5402_3ce3d4a0-4802-4258-84ea-7b565ac19501 60681-5402 HUMAN OTC DRUG Pleo Ut S mycobacterium phlei CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM PHLEI 4 [hp_X]/1 60681-5403_04ec67e5-8994-404b-a697-73c4bf70e9e1 60681-5403 HUMAN OTC DRUG Pleo Ut S mycobacterium phlei CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM PHLEI 6 [hp_X]/1 60681-5404_809d46d6-9a25-430c-b701-5e248038cbdd 60681-5404 HUMAN OTC DRUG Pleo Ut S mycobacterium phlei SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM PHLEI 6 [HP_X]/1 60681-5405_72be2eeb-00cc-4d36-aab7-bf05df47bb48 60681-5405 HUMAN OTC DRUG Pleo Ut S mycobacterium phlei LIQUID ORAL 20051101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM PHLEI 4 [hp_X]/mL 60681-5407_955446fc-5f68-4100-b708-8b1602ffc9f8 60681-5407 HUMAN OTC DRUG Pleo Ut S mycobacterium phlei SOLUTION/ DROPS ORAL 20051101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM PHLEI 6 [hp_X]/mL 60681-5501_4df558df-6c72-4b74-b0a0-ae2ad55a9b98 60681-5501 HUMAN OTC DRUG Pleo Zinc zinc LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ZINC 4 [hp_X]/2mL 60681-5502_b46d942a-3995-4d07-adc1-6d1794a6af37 60681-5502 HUMAN OTC DRUG Pleo Zinc zinc gluconate SOLUTION/ DROPS ORAL 20100615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ZINC GLUCONATE 3 [hp_X]/30mL 60681-5601_7b103d01-a1ae-49ed-8698-46d8227a5bd8 60681-5601 HUMAN OTC DRUG Pleo Usti ustilago maydis SOLUTION/ DROPS ORAL 19980819 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG USTILAGO MAYDIS 5 [hp_X]/10mL 60681-5603_c44bf99d-7fef-477e-abf2-7d79fd15e2d5 60681-5603 HUMAN OTC DRUG Pleo Usti ustilago maydis SOLUTION/ DROPS ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG USTILAGO MAYDIS 5 [HP_X]/10mL 60681-5604_c720aca5-a43e-47d2-8928-ed6182ba5e5c 60681-5604 HUMAN OTC DRUG Pleo Usti ustilago maydis SUPPOSITORY RECTAL 20040421 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG USTILAGO MAYDIS 5 [HP_X]/1 60681-5701_abab75e4-2a2b-4f80-83dd-1438222c78cf 60681-5701 HUMAN OTC DRUG Pleo Ver Trichophyton Verrucosum SOLUTION/ DROPS ORAL 20110201 UNAPPROVED DRUG OTHER SANUM-KEHLBECK GMBH & CO KG TRICHOPHYTON VERRUCOSUM 6 [hp_X]/10mL 60681-6001_10098eed-072a-409e-8873-02a570e3c285 60681-6001 HUMAN OTC DRUG Pleo Alkala Antacid sodium bicarbonate, potassium bicarbonate and sodium citrate POWDER ORAL 19961219 OTC MONOGRAPH FINAL part331 Sanum Kehlbeck GmbH & Co. KG POTASSIUM BICARBONATE; SODIUM BICARBONATE; SODIUM CITRATE 117; 11.7; 2.4 g/150g; g/150g; g/150g 60681-6100_cb92989a-98b5-46d3-82e8-cbedde97d667 60681-6100 HUMAN OTC DRUG Pleo Chelate magnesium sulfate, potassium chloride and sodium chloride SOLUTION/ DROPS ORAL 19961231 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 2; 2; 2 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 60681-6200_5b89aff2-2715-4732-aef1-73cada3ca3d0 60681-6200 HUMAN OTC DRUG Pleo Relivora drosera rotundifolia, echinacea angustifolia root and english walnut SOLUTION/ DROPS ORAL 19961231 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG DROSERA ROTUNDIFOLIA; ECHINACEA ANGUSTIFOLIA ROOT; ENGLISH WALNUT 3; 2; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 60681-6201_88957f1b-2e09-4ba3-bbc7-5b902de2d795 60681-6201 HUMAN OTC DRUG Pleo Relivora Complex drosera rotundifolia, echinacea angustifolia root and english walnut LIQUID ORAL 19970102 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG DROSERA ROTUNDIFOLIA; ECHINACEA ANGUSTIFOLIA ROOT; ENGLISH WALNUT 3; 4; 4 [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL 60681-6300_07979e63-5919-4479-a97b-287e56e0b182 60681-6300 HUMAN OTC DRUG Pleo Sanuvis lactic acid, l- KIT 19970219 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG 60681-6301_3d49e515-0833-4585-bcbd-e8382a0bb006 60681-6301 HUMAN OTC DRUG Pleo Sanuvis lactic acid, l- OINTMENT TOPICAL 20100615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG LACTIC ACID, L- 1 [hp_X]/30g 60681-6302_fa8b2bd5-bd6e-481a-a140-6d2f942c9391 60681-6302 HUMAN OTC DRUG Pleo Sanuvis lactic acid, l- KIT 20040524 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG 60681-6303_cf624845-c731-43a4-b2e2-b5a93d4ebc52 60681-6303 HUMAN OTC DRUG Pleo Sanuvis lactic acid, l- TABLET ORAL 20100615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG LACTIC ACID, L- 200 [hp_X]/1 60681-7001_d4433eb6-d5af-442d-896c-58d338e51c73 60681-7001 HUMAN OTC DRUG Pleo Cerivi Cetraria islandica subsp. islandica SOLUTION/ DROPS ORAL 19971231 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CETRARIA ISLANDICA SUBSP. ISLANDICA 1 [hp_X]/30mL 60681-7002_2d067039-1b84-4400-8021-baacc4a92a7a 60681-7002 HUMAN OTC DRUG Pleo Cerivi Cetraria islandica subsp. islandica LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CETRARIA ISLANDICA SUBSP. ISLANDICA 3 [hp_X]/2mL 60681-8001_d5a59c42-6acf-44ed-b190-9d33566d9801 60681-8001 HUMAN OTC DRUG Pleo Citro citric acid monohydrate LIQUID ORAL 19970102 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CITRIC ACID MONOHYDRATE 200 [hp_X]/100mL 60681-8002_19f4669b-95e2-4af2-a432-dc70ec39f10d 60681-8002 HUMAN OTC DRUG Pleo Citro citric acid LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CITRIC ACID; CITRIC ACID; CITRIC ACID 10; 200; 30 [HP_X]/2mL; [HP_X]/2mL; [HP_X]/2mL 60681-8003_58a6a1f3-3b43-487d-8f76-89c6baa50c0a 60681-8003 HUMAN OTC DRUG Pleo Citro CITRIC ACID MONOHYDRATE TABLET ORAL 20120710 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG CITRIC ACID MONOHYDRATE 200 [hp_X]/1 60681-9001_e6368c75-5aa2-4229-a7b9-9311e3dd8686 60681-9001 HUMAN OTC DRUG Pleo Ginkgo ginkgo biloba leaf SOLUTION/ DROPS ORAL 19961219 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG GINKGO BILOBA LEAF 1 [HP_X]/30mL 60681-9002_2cfd2e4e-c605-4f81-86b0-5c579eb77b3e 60681-9002 HUMAN OTC DRUG Pleo Ginkgo GINKGO BILOBA LEAF LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG GINKGO BILOBA LEAF 4 [hp_X]/2mL 60681-9011_928bf3d1-cea6-499e-9fe5-a432c72940cc 60681-9011 HUMAN OTC DRUG Pleo Stroph strophanthus hispidus SOLUTION/ DROPS ORAL 20060221 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG STROPHANTHUS HISPIDUS 4 [hp_X]/30mL 60681-9012_7287da4b-e29d-4d1f-bf20-f1a8f08d2c67 60681-9012 HUMAN OTC DRUG Pleo Stroph strophanthus hispidus TABLET ORAL 20060221 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG STROPHANTHUS HISPIDUS 4 [hp_X]/1 60683-075_e3fb105f-c3bc-4acf-b5aa-5875732165c4 60683-075 HUMAN OTC DRUG Rapid Comfort Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20110727 ANDA ANDA075139 Lab Safety Supply, Inc. IBUPROFEN 200 mg/1 60683-082_3a340516-fd91-49e1-92f9-1be256b0de59 60683-082 HUMAN OTC DRUG Rapid Comfort Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20121011 ANDA ANDA071333 Lab Safety Supply, Inc. IBUPROFEN 200 mg/1 60683-083_3a340516-fd91-49e1-92f9-1be256b0de59 60683-083 HUMAN OTC DRUG Rapid Comfort Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20121011 ANDA ANDA091237 Lab Safety Supply, Inc. IBUPROFEN 200 mg/1 60683-106_a673ad81-f5d9-434c-b108-7eb00ce01489 60683-106 HUMAN OTC DRUG Rapid Comfort Aspirin Aspirin TABLET, FILM COATED ORAL 20111014 OTC MONOGRAPH FINAL part343 Lab Safety Supply, Inc. ASPIRIN 325 mg/1 60683-111_16707a48-a663-47b6-af96-c17116fbda3b 60683-111 HUMAN OTC DRUG Rapid Comfort Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20111014 OTC MONOGRAPH NOT FINAL part343 Lab Safety Supply, Inc. ACETAMINOPHEN 325 mg/1 60683-121_a82be2c1-4eec-4966-aa6e-68a9e4f87144 60683-121 HUMAN OTC DRUG Rapid Comfort Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20111014 OTC MONOGRAPH NOT FINAL part343 Lab Safety Supply, Inc. ACETAMINOPHEN 325 mg/1 60683-124_7b12d49a-cfa8-44b5-bfd1-0ef59ec4e0e9 60683-124 HUMAN OTC DRUG Rapid Comfort Extra Strength Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20111014 OTC MONOGRAPH NOT FINAL part343 Lab Safety Supply, Inc. ACETAMINOPHEN 500 mg/1 60683-129_6a98ed6e-10ba-4a18-b3b7-2fca334b4c82 60683-129 HUMAN OTC DRUG Rapid Comfort Extra Strength Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20111014 OTC MONOGRAPH NOT FINAL part343 Lab Safety Supply, Inc. ACETAMINOPHEN 500 mg/1 60687-100_9ae9412b-36d5-4634-8d5c-cc96110821c0 60687-100 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20141205 ANDA ANDA079082 American Health Packaging URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 60691-114_92907e2a-bd56-4f22-91c7-801f26ca4905 60691-114 HUMAN OTC DRUG MIRACLE ICE Arthritis Pain Reliever Menthol and Camphor (synthetic) GEL TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part348 FDN Enterprises, LLC CAMPHOR (SYNTHETIC); MENTHOL .5; 1 g/100g; g/100g 60691-115_dc4844de-e386-4040-8b1c-9097fa7270c9 60691-115 HUMAN OTC DRUG MIRACLE ICE Menthol and Camphor (synthetic) GEL TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part348 FDN Enterprises, LLC CAMPHOR (SYNTHETIC); MENTHOL .5; 1 g/100g; g/100g 60691-116_10137856-eae0-45b1-bf9a-1412c8775a5b 60691-116 HUMAN OTC DRUG Miracle Ice Ultra Strength Menthol and Camphor (synthetic) GEL TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part348 FDN Enterprises,LLC CAMPHOR (SYNTHETIC); MENTHOL .5; 1 g/100g; g/100g 60691-117_9f93e6b6-0a51-4039-b217-daae7b62e9f9 60691-117 HUMAN OTC DRUG Miracle Ice Therapeutic Menthol and Camphor (synthetic) GEL TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part348 FDN Enterprises, LLC CAMPHOR (SYNTHETIC); MENTHOL .5; 1 g/100g; g/100g 60691-123_2fd41533-9341-4f3a-ab97-4326adfb98a8 60691-123 HUMAN OTC DRUG Classic Care Baby Petrolatum JELLY TOPICAL 20110530 OTC MONOGRAPH FINAL part347 FDN Enterprises, LLC PETROLATUM 998 mg/g 60691-124_21ce8420-dc91-48d7-a361-a8d8d64bd224 60691-124 HUMAN OTC DRUG Classic Care Apricot Scrub Blemish Control Salicylic Acid CREAM TOPICAL 20120926 OTC MONOGRAPH FINAL part333D FDN Enterprises, LLC SALICYLIC ACID 2 g/100g 60696-1234_1776f3df-eb69-404e-98af-644f43ae0528 60696-1234 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19820101 UNAPPROVED MEDICAL GAS Kalispell Medical Equipment OXYGEN 99 L/100L 60698-0000_2a86514f-5a45-4180-b6d2-36206b7cbe21 60698-0000 HUMAN OTC DRUG Notaflu Lemon Oil LEMON OIL SPRAY NASAL 20130916 UNAPPROVED HOMEOPATHIC RC InnPharma Corporation LEMON OIL 1 [hp_X]/30mL 60698-0001_aee671c5-9b19-4de9-a2fb-ca4b45409273 60698-0001 HUMAN OTC DRUG Notaflu Lemon Oil LEMON OIL SPRAY ORAL 20130916 UNAPPROVED HOMEOPATHIC RC InnPharma Corporation LEMON OIL 1 [hp_X]/30mL 60709-100_dae2223b-f850-4bdb-a68b-f38b76954b8b 60709-100 HUMAN OTC DRUG NANO PPC NANO PPC CREAM TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part343 YBK Investment, INC CAFFEINE 5 mg/1000mL 60709-101_d3fe3a8f-ccc1-4478-97d8-68a9ea0315d9 60709-101 HUMAN OTC DRUG Skin Delight Mask Pack Plus Mask Pack PATCH TOPICAL 20131021 UNAPPROVED DRUG OTHER YBK Investment, INC PREZATIDE COPPER .22 mg/22g 60709-102_04af745b-a80d-4d4a-8942-ee35f236a82f 60709-102 HUMAN OTC DRUG Cosmeceutical Mask Pack Mask Pack PATCH TOPICAL 20131021 UNAPPROVED DRUG OTHER YBK Investment, INC BASIC FIBROBLAST GROWTH FACTOR (HUMAN); MECASERMIN; NEPIDERMIN; PALMITOYL OLIGOPEPTIDE; PREZATIDE COPPER; THIOREDOXIN .044; .044; .044; .044; .22; .044 mg/22g; mg/22g; mg/22g; mg/22g; mg/22g; mg/22g 60709-105_33cc0c1b-0f86-4e00-a346-44e8effaabbc 60709-105 HUMAN OTC DRUG Dermaheal Cosmeceutical Mask Pack Plus Copper Tripeptide-1 (0.001%) PATCH TOPICAL 20131021 UNAPPROVED DRUG OTHER YBK Investment, INC BASIC FIBROBLAST GROWTH FACTOR (HUMAN); MECASERMIN; NEPIDERMIN; PALMITOYL OLIGOPEPTIDE; PREZATIDE COPPER; THIOREDOXIN .044; .044; .044; .044; .22; .044 mg/22g; mg/22g; mg/22g; mg/22g; mg/22g; mg/22g 60709-106_91f9fa8d-7bce-4ba2-8764-defa0e0dcb43 60709-106 HUMAN OTC DRUG Dermaheal Skin Delight Mask Pack Plus Copper Tripeptide-1 (0.001%) PATCH TOPICAL 20131021 UNAPPROVED DRUG OTHER YBK Investment, INC PREZATIDE COPPER .22 mg/22g 60709-107_f1811ea6-640d-40bf-ae08-05d9e9d476ad 60709-107 HUMAN OTC DRUG NANO PPC Caffeine CREAM TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part343 YBK Investment, INC CAFFEINE; VANILLYL BUTYL ETHER 1.25; 2.5 mg/250mL; mg/250mL 60710-2320_02c817dd-1c13-4f8a-8bc0-56be0e39dfa9 60710-2320 HUMAN PRESCRIPTION DRUG ZINC INJECTABLE A 1mg/ml, solution injectable pour perfusion Zinc INJECTION, SOLUTION INTRAVENOUS 20131001 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Laboratoire Aguettant ZINC GLUCONATE TRIHYDRATE 1 mg/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 60716-010_46ebe6bd-9823-44b7-854b-7e949834c69f 60716-010 HUMAN OTC DRUG RENOKIN HAIR REVITALIZING Allantoin SHAMPOO TOPICAL 20140102 OTC MONOGRAPH FINAL part347 Caregen Co., Ltd. ALLANTOIN .75 mg/150mL 60716-020_0c747cda-4b74-4739-a399-5eb788a656d4 60716-020 HUMAN OTC DRUG RENOKIN HAIR REVITALIZING CONDITIONER Dimethicone LIQUID TOPICAL 20140102 OTC MONOGRAPH FINAL part347 Caregen Co., Ltd. DIMETHICONE 1.1 mg/110mL 60716-030_22565595-f3f1-4b40-b8cb-cdf58deaedfa 60716-030 HUMAN OTC DRUG RENOKIN HAIR REVITALIZING Allantoin SOLUTION TOPICAL 20140102 OTC MONOGRAPH FINAL part347 Caregen Co., Ltd. ALLANTOIN .3 mg/60mL 60716-040_e1e74c73-2df9-4296-95ca-e055716b2c38 60716-040 HUMAN OTC DRUG RENOKIN LASH LASH Allantoin LIQUID TOPICAL 20140307 OTC MONOGRAPH FINAL part347 Caregen Co., Ltd. ALLANTOIN .025 mg/5mL 60717-001_188c333e-8fc8-4838-9555-ab34df9372a8 60717-001 HUMAN OTC DRUG HAND SANITIZER with ALOE VERA ALCOHOL LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333E RNA PHARMA LLC ALCOHOL 65 mL/mL 60723-031_c77553bd-03a7-4c23-b80a-477517394eeb 60723-031 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, COATED ORAL 20131231 ANDA ANDA203590 Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60723-032_c77553bd-03a7-4c23-b80a-477517394eeb 60723-032 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, COATED ORAL 20131231 ANDA ANDA203590 Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60723-033_c77553bd-03a7-4c23-b80a-477517394eeb 60723-033 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, COATED ORAL 20131231 ANDA ANDA203590 Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60724-101_67ff6112-769d-4b0f-919a-0a56e476fdd7 60724-101 HUMAN OTC DRUG BEING TRUE ESSENTIALS ABSOLUTELY RADIANT OCTISALATE, HOMOSALATE, AVOBENZONE AND OCTOCRYLENE LOTION TOPICAL 20130919 OTC MONOGRAPH FINAL part352 TRUE Cosmetics LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 2.7 g/100mL; g/100mL; g/100mL; g/100mL 60742-001_446a696f-296f-45e3-abd2-d87b5d6e47e8 60742-001 HUMAN OTC DRUG One Step Hand Sanitizer Aloe ALCOHOL GEL TOPICAL 20120131 OTC MONOGRAPH NOT FINAL part356 BELVEDERE INTERNATIONAL INC. ALCOHOL 62 mL/100mL 60742-002_9152d5e7-8ca5-4df6-99da-8fb47aa62941 60742-002 HUMAN OTC DRUG DG Deep Cleaning Astringent Sensitive Skin SALICYLIC ACID LIQUID TOPICAL 20130131 OTC MONOGRAPH NOT FINAL part333D BELVEDERE INTERNATIONAL INC. SALICYLIC ACID .5 g/100g 60742-175_19114c5f-d78d-4787-80e4-fc550b261221 60742-175 HUMAN OTC DRUG One Step Sanitizer ALCOHOL SPRAY TOPICAL 20120209 OTC MONOGRAPH NOT FINAL part356 Belvedere International Inc. ALCOHOL 62 mL/100mL 60742-200_20ee27be-928d-4aed-a470-8d7120b562e1 60742-200 HUMAN OTC DRUG One Step Wipes ALCOHOL LIQUID TOPICAL 20120131 OTC MONOGRAPH NOT FINAL part356 BELVEDERE INTERNATIONAL INC. ALCOHOL 62 mL/100mL 60742-473_7e061051-8dec-42b1-8b3c-390875b8cab4 60742-473 HUMAN OTC DRUG One Step Hand Sanitizer ALCOHOL GEL TOPICAL 20120127 OTC MONOGRAPH NOT FINAL part356 Belvedere International Inc. ALCOHOL 62 mL/100mL 60758-060_cbba72cc-ab04-4eba-aed2-980088b27994 60758-060 HUMAN PRESCRIPTION DRUG LEVOBUNOLOL HYDROCHLORIDE levobunolol hydrochloride SOLUTION/ DROPS OPHTHALMIC 19970715 NDA AUTHORIZED GENERIC NDA019219 Pacific Pharma, Inc. LEVOBUNOLOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60758-063_cbba72cc-ab04-4eba-aed2-980088b27994 60758-063 HUMAN PRESCRIPTION DRUG LEVOBUNOLOL HYDROCHLORIDE levobunolol hydrochloride SOLUTION/ DROPS OPHTHALMIC 19970715 20150118 NDA AUTHORIZED GENERIC NDA019814 Pacific Pharma, Inc. LEVOBUNOLOL HYDROCHLORIDE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60758-119_13493d76-5f5b-4752-a22e-8d707cb90530 60758-119 HUMAN PRESCRIPTION DRUG PREDNISOLONE ACETATE prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19970819 NDA AUTHORIZED GENERIC NDA017011 Pacific Pharma, Inc. PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60758-188_eaee2ec5-bad5-4a13-968d-b040e83d2d03 60758-188 HUMAN PRESCRIPTION DRUG GENTAMICIN SULFATE gentamicin sulfate SOLUTION/ DROPS OPHTHALMIC 19980105 ANDA ANDA062452 Pacific Pharma, Inc. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 60758-773_6584c828-a0a7-4c40-a180-88be937c0ed8 60758-773 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE Ketorolac Tromethamine SOLUTION/ DROPS OPHTHALMIC 20131121 NDA AUTHORIZED GENERIC NDA021528 Pacific Pharma, Inc. KETOROLAC TROMETHAMINE 4 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60758-801_a8bd9310-8bbe-4e69-ae2a-fc0ab9dfabeb 60758-801 HUMAN PRESCRIPTION DRUG TIMOLOL MALEATE timolol maleate SOLUTION/ DROPS OPHTHALMIC 19970520 ANDA ANDA074747 Pacific Pharma, Inc. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60758-802_a8bd9310-8bbe-4e69-ae2a-fc0ab9dfabeb 60758-802 HUMAN PRESCRIPTION DRUG TIMOLOL MALEATE timolol maleate SOLUTION/ DROPS OPHTHALMIC 19970520 ANDA ANDA074746 Pacific Pharma, Inc. TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60758-866_d28e9c1d-f8a5-4801-965e-cf9e00faecd4 60758-866 HUMAN PRESCRIPTION DRUG BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/ DROPS OPHTHALMIC 20030410 NDA AUTHORIZED GENERIC NDA020613 Pacific Pharma, Inc. BRIMONIDINE TARTRATE 2 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 60758-880_00158fa8-e3a5-46f6-9e29-9371a5a0882a 60758-880 HUMAN PRESCRIPTION DRUG FLUOROMETHOLONE fluorometholone SOLUTION/ DROPS OPHTHALMIC 19971031 NDA AUTHORIZED GENERIC NDA016851 Pacific Pharma, Inc. FLUOROMETHOLONE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 60758-908_04873965-c1fa-4612-8ebe-12337a7f5657 60758-908 HUMAN PRESCRIPTION DRUG POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate SOLUTION/ DROPS OPHTHALMIC 19970429 NDA AUTHORIZED GENERIC NDA050567 Pacific Pharma, Inc. POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 60758-910_447ff27c-e18c-4464-acb0-c96675985904 60758-910 HUMAN PRESCRIPTION DRUG FLURBIPROFEN SODIUM flurbiprofen sodium SOLUTION/ DROPS OPHTHALMIC 19970529 NDA AUTHORIZED GENERIC NDA019404 Pacific Pharma, Inc. FLURBIPROFEN SODIUM .3 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60760-003_b418cb13-c4c8-46e0-9c4a-e273ba0f69ee 60760-003 HUMAN PRESCRIPTION DRUG DIGOX DIGOXIN TABLET ORAL 20130502 ANDA ANDA076268 St Marys Medical Park Pharmacy DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 60760-005_8c40df3e-bfe1-4b64-8557-66533931f999 60760-005 HUMAN PRESCRIPTION DRUG SIMVASTATIN simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 St Marys Medical Park Pharmacy SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60760-006_8c40df3e-bfe1-4b64-8557-66533931f999 60760-006 HUMAN PRESCRIPTION DRUG SIMVASTATIN simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 St Marys Medical Park Pharmacy SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60760-007_2b4758a6-0ee6-40c8-a494-e29a2f6e966a 60760-007 HUMAN PRESCRIPTION DRUG DOXAZOSIN DOXAZOSIN MESYLATE TABLET ORAL 20130502 ANDA ANDA075536 St Marys Medical Park Pharmacy DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60760-009_09d0f22a-e9cb-4b17-a823-b76009f02c94 60760-009 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 St Marys Medical Park Pharmacy CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60760-016_cf28d2ca-864b-4f06-a387-3c6390e9c3eb 60760-016 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20101231 NDA AUTHORIZED GENERIC NDA021724 St Marys Medical Park Pharmacy PREGABALIN 150 mg/1 CV 60760-018_cf28d2ca-864b-4f06-a387-3c6390e9c3eb 60760-018 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20101231 NDA AUTHORIZED GENERIC NDA021724 St Marys Medical Park Pharmacy PREGABALIN 200 mg/1 CV 60760-019_8c40df3e-bfe1-4b64-8557-66533931f999 60760-019 HUMAN PRESCRIPTION DRUG SIMVASTATIN simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 St Marys Medical Park Pharmacy SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60760-024_f0205e2d-8947-4091-90ec-ee8383bd79ff 60760-024 HUMAN PRESCRIPTION DRUG GLIPIZIDE GLIPIZIDE TABLET ORAL 20130509 ANDA ANDA075795 St Marys Medical Park Pharmacy GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 60760-026_9ec19a8f-9f1b-4185-bb96-229100e812da 60760-026 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 20140130 ANDA ANDA077824 St Marys Medical Park Pharmacy RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 60760-027_19c54f57-6de3-4c49-9d23-3c594053db8d 60760-027 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20100301 ANDA ANDA070974 St Marys Medical Park Pharmacy CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 60760-032_3cf058e2-a577-4245-8aaa-837e401e512b 60760-032 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 St. Mary's Medical Park Pharmacy ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 60760-035_c0d37c7c-05e5-401f-91e5-c4d644fbf1e7 60760-035 HUMAN PRESCRIPTION DRUG GABAPENTIN Gabapentin CAPSULE ORAL 20101201 ANDA ANDA075350 St Marys Medical Park Pharmacy GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60760-036_dfb7c148-d7f1-46d3-95e1-3dea6b75c5a9 60760-036 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20130515 ANDA ANDA075155 St Marys Medical Park Pharmacy ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 60760-037_dfb7c148-d7f1-46d3-95e1-3dea6b75c5a9 60760-037 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20130515 ANDA ANDA075155 St Marys Medical Park Pharmacy ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 60760-038_a7bab640-a6e2-4c75-b54f-4d556cbc9f6a 60760-038 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20101203 ANDA ANDA077525 St Marys Medical Park Pharmacy GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60760-040_cc1aaeda-96e9-4e63-bbd4-cf8561386e13 60760-040 HUMAN PRESCRIPTION DRUG WARFARIN SODIUM WARFARIN SODIUM TABLET ORAL 20130815 ANDA ANDA040663 St Marys Medical Park Pharmacy WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 60760-041_cc1aaeda-96e9-4e63-bbd4-cf8561386e13 60760-041 HUMAN PRESCRIPTION DRUG WARFARIN SODIUM WARFARIN SODIUM TABLET ORAL 20130815 ANDA ANDA040663 St Marys Medical Park Pharmacy WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 60760-042_7eef57bc-dac4-455e-89a8-e56ecfc63564 60760-042 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 St Marys Medical Park Pharmacy METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 60760-043_cc1aaeda-96e9-4e63-bbd4-cf8561386e13 60760-043 HUMAN PRESCRIPTION DRUG WARFARIN SODIUM WARFARIN SODIUM TABLET ORAL 20130815 ANDA ANDA040663 St Marys Medical Park Pharmacy WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 60760-045_945bcb55-23ce-499a-b242-c2e5dbfdf6fe 60760-045 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET ORAL 20140522 OTC MONOGRAPH FINAL part343 St Marys Medical Park Pharmacy ASPIRIN 81 mg/1 60760-049_89c8e02e-02d4-4e49-bc95-2629f82f7ee9 60760-049 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101230 NDA NDA020553 St Marys Medical Park Pharmacy OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60760-051_0b8ffbdd-3e92-4f3c-b0ab-354f843f644d 60760-051 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 St Marys Medical Park Pharmacy BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 60760-053_44ee7e6c-fed0-435e-a1b2-e5dea222db05 60760-053 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 St. Mary's Medical Park Pharmacy ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 60760-054_1ed4d124-3b9a-47fa-b735-3e74511624dc 60760-054 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20110130 NDA NDA020859 St. Marys Medical Park Pharmacy METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 60760-059_dbf1cac8-978d-4345-92c9-7131dc08b929 60760-059 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 St Marys Medical Park Pharmacy ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60760-060_dbf1cac8-978d-4345-92c9-7131dc08b929 60760-060 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 St Marys Medical Park Pharmacy ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60760-061_52c02349-f89f-4fa3-9bdb-6e85c6d9c4d3 60760-061 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20130710 ANDA ANDA077877 St Marys Medical Park Pharmacy ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60760-063_984f5dcd-bb42-460b-96ef-c6a646306bbb 60760-063 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20130516 ANDA ANDA077912 St Marys Medical Park Pharmacy HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60760-064_984f5dcd-bb42-460b-96ef-c6a646306bbb 60760-064 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20130516 ANDA ANDA077912 St Marys Medical Park Pharmacy HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60760-065_984f5dcd-bb42-460b-96ef-c6a646306bbb 60760-065 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20130516 ANDA ANDA077912 St Marys Medical Park Pharmacy HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60760-072_36fee6de-44a2-48e9-a283-199006a086ff 60760-072 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130710 ANDA ANDA090492 St Marys Medical Park Pharmacy DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60760-073_adad2368-4c52-45ef-849f-692457e02773 60760-073 HUMAN PRESCRIPTION DRUG DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140814 ANDA ANDA075124 St Marys Medical Park Pharmacy DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60760-077_31a470dd-59ba-49fe-abff-76b82b98949e 60760-077 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20130814 ANDA ANDA077751 St Marys Medical Park Pharmacy PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60760-078_31a470dd-59ba-49fe-abff-76b82b98949e 60760-078 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20130814 ANDA ANDA077751 St Marys Medical Park Pharmacy PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60760-082_2ad58b83-5541-4021-9a81-1a3629cd70a1 60760-082 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20140115 ANDA ANDA076820 St Marys Medical Park Pharmacy BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60760-083_6ca79041-bec0-4c1e-862b-6fefb4e8ef37 60760-083 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20140115 ANDA ANDA076118 St Marys Medical Park Pharmacy BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60760-104_dc5901bc-99a7-45b0-87b9-37368a423ae4 60760-104 HUMAN OTC DRUG FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130110 ANDA ANDA076447 St Marys Medical Park Pharmacy FEXOFENADINE HYDROCHLORIDE 180 mg/1 60760-106_cf28d2ca-864b-4f06-a387-3c6390e9c3eb 60760-106 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20101231 NDA NDA021724 St Marys Medical Park Pharmacy PREGABALIN 100 mg/1 CV 60760-114_2068bbd7-b960-468b-8b20-9b95835147ad 60760-114 HUMAN PRESCRIPTION DRUG Allopurinol ALLOPURINOL TABLET ORAL 20130425 ANDA ANDA075798 St Marys Medical Park Pharmacy ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 60760-116_3b301e9c-694b-4079-bf05-05540ffc380a 60760-116 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Extended Release ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130110 ANDA ANDA078148 St Marys Medical Park Pharmacy ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 60760-118_c72b91b2-caa5-47e5-a467-07f9fe8e916b 60760-118 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20140220 ANDA ANDA090637 St Marys Medical Park Pharmacy ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 60760-121_e741e932-2307-4849-af17-1d5d14396c62 60760-121 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20110130 ANDA ANDA077653 St. Marys Medical Park Pharmacy VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60760-124_ad922e81-9a64-46e4-bffc-b16b6ceb3044 60760-124 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20140522 ANDA ANDA040301 St Marys Medical Park Pharmacy WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 60760-126_af301c02-9839-4418-a70f-ba2e488f2985 60760-126 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20140123 ANDA ANDA077901 St Marys Medical Park Pharmacy CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 60760-128_d2852ac9-333c-4517-a5e0-af6b0ae2d07e 60760-128 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 St Marys Medical Park Pharmacy LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60760-129_5b2cd8a0-3c31-4430-8446-211eddd59997 60760-129 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20130711 ANDA ANDA090467 St Marys Medical Park Pharmacy LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60760-130_5b2cd8a0-3c31-4430-8446-211eddd59997 60760-130 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20130711 ANDA ANDA090467 St Marys Medical Park Pharmacy LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60760-131_af301c02-9839-4418-a70f-ba2e488f2985 60760-131 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20140123 ANDA ANDA077901 St Marys Medical Park Pharmacy CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 60760-133_d80ffcf8-3810-4706-9415-21c5046b54a9 60760-133 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET ORAL 20140421 ANDA ANDA090467 St Marys Medical Park Pharmacy LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60760-141_f0205e2d-8947-4091-90ec-ee8383bd79ff 60760-141 HUMAN PRESCRIPTION DRUG GLIPIZIDE GLIPIZIDE TABLET ORAL 20130509 ANDA ANDA075795 St Marys Medical Park Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 60760-142_a78494c6-e60b-40c0-8cd0-8667b7c875b4 60760-142 HUMAN PRESCRIPTION DRUG CARVEDILOL CARVEDILOL TABLET, FILM COATED ORAL 20130425 ANDA ANDA078332 St Marys Medical Park Pharmacy CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 60760-143_a78494c6-e60b-40c0-8cd0-8667b7c875b4 60760-143 HUMAN PRESCRIPTION DRUG CARVEDILOL CARVEDILOL TABLET, FILM COATED ORAL 20130425 ANDA ANDA078332 St Marys Medical Park Pharmacy CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 60760-144_a78494c6-e60b-40c0-8cd0-8667b7c875b4 60760-144 HUMAN PRESCRIPTION DRUG CARVEDILOL CARVEDILOL TABLET, FILM COATED ORAL 20130425 ANDA ANDA078332 St Marys Medical Park Pharmacy CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 60760-145_a78494c6-e60b-40c0-8cd0-8667b7c875b4 60760-145 HUMAN PRESCRIPTION DRUG CARVEDILOL CARVEDILOL TABLET, FILM COATED ORAL 20130425 ANDA ANDA078332 St Marys Medical Park Pharmacy CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 60760-167_db1052ae-94a7-4cbf-b771-c5a7f25dd5ed 60760-167 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20140421 ANDA ANDA075580 St Marys Medical Park Pharmacy DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60760-168_db1052ae-94a7-4cbf-b771-c5a7f25dd5ed 60760-168 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20140421 ANDA ANDA075580 St Marys Medical Park Pharmacy DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60760-175_c5345f61-fa48-4d1a-83eb-d9ddea43e4a0 60760-175 HUMAN PRESCRIPTION DRUG GLIPIZIDE and METFORMIN HYDROCHLORIDE GLIPIZIDE and METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20130509 ANDA ANDA077270 St Marys Medical Park Pharmacy GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 60760-176_c5345f61-fa48-4d1a-83eb-d9ddea43e4a0 60760-176 HUMAN PRESCRIPTION DRUG GLIPIZIDE and METFORMIN HYDROCHLORIDE GLIPIZIDE and METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20130509 ANDA ANDA077270 St Marys Medical Park Pharmacy GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 60760-182_0e44d202-f654-4de3-8d53-043b09e55e77 60760-182 HUMAN PRESCRIPTION DRUG NIFEDIPINE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130515 ANDA ANDA077127 St Marys Medical Park Pharmacy NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 60760-183_0e44d202-f654-4de3-8d53-043b09e55e77 60760-183 HUMAN PRESCRIPTION DRUG NIFEDIPINE NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130515 ANDA ANDA077127 St Marys Medical Park Pharmacy NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 60760-191_0a2d8011-e4e5-4d73-afdb-561b01ed7012 60760-191 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 St Marys Medical Park Pharmacy ESZOPICLONE 2 mg/1 CIV 60760-193_0a2d8011-e4e5-4d73-afdb-561b01ed7012 60760-193 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 St Marys Medical Park Pharmacy ESZOPICLONE 3 mg/1 CIV 60760-200_98dd9ddf-c8e4-4dba-8a8f-2e6a0d25c606 60760-200 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20090608 ANDA ANDA040777 St. Mary's Medical Park Pharmacy ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60760-202_3cf058e2-a577-4245-8aaa-837e401e512b 60760-202 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 St. Mary's Medical Park Pharmacy ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 60760-204_5553ffad-bdc7-43c9-ade9-fed5c9762ec3 60760-204 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, ACETAMINOPHEN TABLET ORAL 20101217 ANDA ANDA040535 St Marys Medical Park Pharmacy ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60760-211_225f5d45-958d-455c-836b-3affdd9a1548 60760-211 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20101215 ANDA ANDA078989 St Marys Medical Park Pharmacy ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 60760-214_4cbb76ac-d42d-4f39-87bd-89cc83118914 60760-214 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET ORAL 20091201 ANDA ANDA040218 St. Mary's Medical Park Pharmacy AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 60760-215_9754c287-499f-45c6-814c-85a25f189e85 60760-215 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 St Marys Medical Park Pharmacy DOXYCYCLINE HYCLATE 100 mg/1 60760-223_352d097e-42c3-4857-8dd8-20366cfbb8e3 60760-223 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20130110 ANDA ANDA090659 St Marys Medical Park Pharmacy OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60760-224_a9983515-35eb-4251-a574-49850b79fcfb 60760-224 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20140123 ANDA ANDA075483 St Marys Medical Park Pharmacy ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60760-225_a9983515-35eb-4251-a574-49850b79fcfb 60760-225 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20140123 ANDA ANDA075483 St Marys Medical Park Pharmacy ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60760-226_9ff60723-bd5f-449c-a500-bf99464f04b0 60760-226 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20140421 ANDA ANDA075483 St Marys Medical Park Pharmacy ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60760-227_9ff60723-bd5f-449c-a500-bf99464f04b0 60760-227 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20140421 ANDA ANDA075483 St Marys Medical Park Pharmacy ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 60760-228_ad2427ec-7d54-4f3e-855f-9399f004b6be 60760-228 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20140523 ANDA ANDA077091 St Marys Medical Park Pharmacy GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 60760-229_61355758-edd8-47cf-acfe-c545f499010a 60760-229 HUMAN PRESCRIPTION DRUG GLIMEPIRIDE GLIMEPIRIDE TABLET ORAL 20130509 ANDA ANDA077091 St Marys Medical Park Pharmacy GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 60760-230_61355758-edd8-47cf-acfe-c545f499010a 60760-230 HUMAN PRESCRIPTION DRUG GLIMEPIRIDE GLIMEPIRIDE TABLET ORAL 20130509 ANDA ANDA077091 St Marys Medical Park Pharmacy GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 60760-238_d9a37209-7251-4cec-a384-0188900cfae2 60760-238 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20130425 ANDA ANDA077995 St Marys Medical Park Pharmacy AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 60760-239_d7186785-070a-4e5c-aa1c-1c455bfacf4e 60760-239 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110901 ANDA ANDA077995 St Marys Medical Park Pharmacy AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 60760-240_58b03527-d82d-47c1-a8de-010eafa4b425 60760-240 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20140501 NDA AUTHORIZED GENERIC NDA019787 St Marys Medical Park Pharmacy AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 60760-250_2f598918-0862-4f5e-86ea-5c8e8581be6b 60760-250 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20140421 ANDA ANDA078459 St Marys Medical Park Pharmacy METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60760-251_284df1bf-fed7-4755-a090-ac924cb6efb9 60760-251 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET ORAL 20130515 ANDA ANDA074644 St Marys Medical Park Pharmacy METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60760-252_284df1bf-fed7-4755-a090-ac924cb6efb9 60760-252 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET ORAL 20130515 ANDA ANDA074644 St Marys Medical Park Pharmacy METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60760-257_ac77429e-d639-4f88-ab2b-250ca3a34373 60760-257 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20140421 ANDA ANDA075805 St Marys Medical Park Pharmacy FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 60760-258_60cd523b-1f91-4520-84db-a755441371eb 60760-258 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20130710 ANDA ANDA075805 St Marys Medical Park Pharmacy FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 60760-265_d8fc4aa8-a85d-4014-ada5-cffba3497829 60760-265 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20140421 ANDA ANDA075994 St Marys Medical Park Pharmacy LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60760-266_e957b3ed-84a1-476a-8330-684958828db3 60760-266 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20130516 ANDA ANDA075743 St Marys Medical Park Pharmacy LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60760-267_d2852ac9-333c-4517-a5e0-af6b0ae2d07e 60760-267 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 St Marys Medical Park Pharmacy LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60760-269_4f321d82-9630-4e70-aebd-85f3a41b1244 60760-269 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20140421 ANDA ANDA075743 St Marys Medical Park Pharmacy LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60760-270_d2852ac9-333c-4517-a5e0-af6b0ae2d07e 60760-270 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 St Marys Medical Park Pharmacy LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60760-271_3b4780f7-cb0d-4b99-b667-746ddeca8146 60760-271 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Extended-Release Diclofenac Sodium TABLET, EXTENDED RELEASE ORAL 20020107 ANDA ANDA075910 St Marys Medical Park Pharmacy DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60760-278_2d607455-651b-404f-9e90-a8a1ce4ce8c5 60760-278 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 St Marys Medical Park Pharmacy TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60760-279_0109efce-8225-4b74-85e0-c270460baa32 60760-279 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET ORAL 20101229 ANDA ANDA079153 St Marys Medical Park Pharmacy TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60760-280_0109efce-8225-4b74-85e0-c270460baa32 60760-280 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET ORAL 20101224 ANDA ANDA079153 St Marys Medical Park Pharmacy TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60760-287_0109efce-8225-4b74-85e0-c270460baa32 60760-287 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET ORAL 20101229 ANDA ANDA079153 St Marys Medical Park Pharmacy TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 60760-291_20eb2053-9fe1-4dc2-8e91-2afbc862740e 60760-291 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20140130 ANDA ANDA075133 St Marys Medical Park Pharmacy LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60760-292_20eb2053-9fe1-4dc2-8e91-2afbc862740e 60760-292 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20140130 ANDA ANDA075133 St Marys Medical Park Pharmacy LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60760-301_55251717-5aad-4751-828b-3b1ea92ea96f 60760-301 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 20140421 ANDA ANDA074532 St Marys Medical Park Pharmacy CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60760-302_a9708bfa-31d9-47a3-9dd1-2ebed0542d21 60760-302 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 20140116 ANDA ANDA074532 St Marys Medical Park Pharmacy CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60760-303_55251717-5aad-4751-828b-3b1ea92ea96f 60760-303 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 20140421 ANDA ANDA074532 St Marys Medical Park Pharmacy CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60760-305_3988483e-144c-47e4-b822-1b58277704c5 60760-305 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20140523 ANDA ANDA090469 St Marys Medical Park Pharmacy ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 60760-309_d31ba4fe-87e8-4d55-bfdb-44c6c5878bd1 60760-309 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20140205 ANDA ANDA077397 St Marys Medical Park Pharmacy SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60760-310_d31ba4fe-87e8-4d55-bfdb-44c6c5878bd1 60760-310 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20140205 ANDA ANDA077397 St Marys Medical Park Pharmacy SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60760-312_1954124e-d4a0-4b6c-b030-c7c2460aaa23 60760-312 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET ORAL 20140522 ANDA ANDA202640 St Marys Medical Park Pharmacy. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 60760-322_feef233e-4d12-454f-9142-fba428135d3d 60760-322 HUMAN PRESCRIPTION DRUG Kadian ER MORPHINE SULFATE CAPSULE ORAL 20101221 NDA NDA020616 St Marys Medical Park Pharmacy MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60760-323_d84a4186-c63b-4caf-87c7-506a1db6fa57 60760-323 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20101231 NDA NDA021427 St Marys Medical Park Pharmacy DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60760-324_d84a4186-c63b-4caf-87c7-506a1db6fa57 60760-324 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20101231 NDA NDA021427 St Marys Medical Park Pharmacy DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60760-334_429f5445-9040-4cd9-8370-16dad7702440 60760-334 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE TABLET ORAL 20130110 ANDA ANDA070033 St Marys Medical Park Pharmacy METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 60760-338_fc98c42b-bf50-4840-9f8c-8d92e80a382e 60760-338 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20140409 NDA NDA021210 St Marys Medical Park Pharmacy LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60760-339_1945b549-4b8b-4cd2-9872-c14cfcf91a42 60760-339 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130711 NDA NDA021210 St Marys Medical Park Pharmacy LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60760-340_a9536c2a-201c-4be4-b118-feaea710e2fb 60760-340 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20130516 NDA NDA021210 St Marys Medical Park Pharmacy LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60760-341_a9536c2a-201c-4be4-b118-feaea710e2fb 60760-341 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LLEVOTHYROXINE SODIUM TABLET ORAL 20130516 NDA NDA021210 St Marys Medical Park Pharmacy LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60760-342_1945b549-4b8b-4cd2-9872-c14cfcf91a42 60760-342 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130711 NDA NDA021210 St Marys Medical Park Pharmacy LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60760-343_1945b549-4b8b-4cd2-9872-c14cfcf91a42 60760-343 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130711 NDA NDA021210 St Marys Medical Park Pharmacy LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60760-344_a9536c2a-201c-4be4-b118-feaea710e2fb 60760-344 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20130516 NDA NDA021210 St Marys Medical Park Pharmacy LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60760-345_daa33322-b617-4b4a-a4e4-6850c8461089 60760-345 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20130110 NDA NDA021210 St Marys Medical Park Pharmacy LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60760-346_a9536c2a-201c-4be4-b118-feaea710e2fb 60760-346 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20130516 NDA NDA021210 St Marys Medical Park Pharmacy LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60760-353_c06f7798-6b3a-4b7f-97ab-138f0b447588 60760-353 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE TABLET, FILM COATED ORAL 20140420 ANDA ANDA090548 St Marys Medical Park Pharmacy ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 60760-354_c06f7798-6b3a-4b7f-97ab-138f0b447588 60760-354 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE TABLET, FILM COATED ORAL 20140420 ANDA ANDA090548 St Marys Medical Park Pharmacy ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 60760-355_2dd7911f-355a-49a5-98b8-2e8885b2ed1b 60760-355 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20140115 ANDA ANDA090548 St Marys Medical Park Pharmacy ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60760-356_c06f7798-6b3a-4b7f-97ab-138f0b447588 60760-356 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE TABLET, FILM COATED ORAL 20140420 ANDA ANDA090548 St Marys Medical Park Pharmacy ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 60760-361_49740290-2a54-4497-945e-78139b3a34d2 60760-361 HUMAN PRESCRIPTION DRUG FOLIC ACID FOLIC ACID TABLET ORAL 20130509 ANDA ANDA040625 St Marys Medical Park Pharmacy FOLIC ACID 1 mg/1 60760-370_894a4c37-31ab-4974-bc27-89916a7e57e0 60760-370 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130711 ANDA ANDA075991 St Marys Medical Park Pharmacy LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60760-371_a53e0717-402e-4185-a7d3-6f98835638fb 60760-371 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140130 ANDA ANDA075991 St Marys Medical Park Pharmacy LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60760-372_8213babd-62f9-4d8a-ba1a-92093a25ae49 60760-372 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140421 ANDA ANDA075991 St Marys Medical Park Pharmacy LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60760-377_511575a0-6c80-4dca-9b87-8e90dfe8ba03 60760-377 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20141006 ANDA ANDA075964 St. Mary's Medical Park Pharmacy TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 60760-379_05649c23-d68b-46a1-83f8-278786cd2c01 60760-379 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20140421 ANDA ANDA078155 St Marys Medical Park Pharmacy SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 60760-385_ec8a1ed5-c7bd-4387-ae41-94e7e76fc112 60760-385 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20120829 ANDA ANDA079081 St Marys Medical Park Pharmacy LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 60760-388_62fb9d28-693e-4da1-bebe-aa567ef23507 60760-388 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 St. Mary's Medical Park Pharmacy ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 60760-389_49184722-3cc5-4641-a4ac-0ba7957bdfae 60760-389 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20061106 ANDA ANDA077723 St Marys Medical Park Pharmacy HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 60760-394_e9b106e4-4404-413d-bef7-f7ff19899467 60760-394 HUMAN PRESCRIPTION DRUG Glipizide XL Glipizide TABLET, EXTENDED RELEASE ORAL 20140523 NDA AUTHORIZED GENERIC NDA020329 St Marys Medical Park Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 60760-406_9fd6aaaf-ce3e-490e-8e1a-850a370b1c32 60760-406 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20140523 ANDA ANDA076268 St Marys Medical Park Pharmacy DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 60760-409_dcd8eb1f-8b2d-4ddd-97c0-d95645b17cb6 60760-409 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20140115 ANDA ANDA077156 St Marys Medical Park Pharmacy BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 60760-410_51d90779-884e-4914-a84a-aae77bae2c88 60760-410 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20140420 ANDA ANDA077068 St Marys Medical Park Pharmacy BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 60760-412_76a5b39a-0d53-407b-bceb-97fe7bd87757 60760-412 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE CAPSULE ORAL 20130515 ANDA ANDA079237 St Marys Medical Park Pharmacy HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60760-413_10577090-d076-4a74-a7b5-837eeace15e0 60760-413 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070501 ANDA ANDA084325 St Marys Medical Park Pharmacy HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60760-414_9bb52664-5bf6-4e16-aaf9-4909c10ec5bd 60760-414 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130710 ANDA ANDA040807 St Marys Medical Park Pharmacy HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60760-420_da836fe4-6dbb-4356-b97e-ed93c4dffd4d 60760-420 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20140421 ANDA ANDA077836 St Marys Medical Park Pharmacy GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 60760-428_5e877fac-cccc-4896-93ea-ce1ba452356d 60760-428 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20140421 ANDA ANDA077222 St Marys Medical Park Pharmacy FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60760-429_c5a2a8b6-3d5c-4706-8c57-604be9e62165 60760-429 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20140522 ANDA ANDA076139 St Marys Medical Park Pharmacy FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 60760-432_6df4696f-9e8b-4974-868b-21f339bd54b4 60760-432 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed-Release Delayed-Release PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20140523 NDA NDA020987 St Marys Medical Park Pharmacy PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 60760-433_c149bbd7-78f4-4f53-8002-e3ba647c2bea 60760-433 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20130808 ANDA ANDA091231 St Marys Medical Park Pharmacy PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 60760-446_bfa68f6b-46ed-4795-8359-08cb89f5ebee 60760-446 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20140522 ANDA ANDA074225 St Marys Medical Park Pharmacy BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 60760-447_c1de9ca7-5aca-46a7-af72-8197376cd69b 60760-447 HUMAN PRESCRIPTION DRUG BUMETANIDE BUMETANIDE TABLET ORAL 20140820 ANDA ANDA074225 St Marys Medical Park Pharmacy BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 60760-463_ec0a2490-5458-41ce-9d12-bca651ad0f89 60760-463 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20140421 ANDA ANDA086242 St Marys Medical Park Pharmacy HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 60760-464_ec0a2490-5458-41ce-9d12-bca651ad0f89 60760-464 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20140421 ANDA ANDA086242 St Marys Medical Park Pharmacy HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 60760-465_ec0a2490-5458-41ce-9d12-bca651ad0f89 60760-465 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20140421 ANDA ANDA086242 St Marys Medical Park Pharmacy HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 60760-488_cfbb21e7-12aa-4f3e-8d9c-25e75b3df07a 60760-488 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140116 ANDA ANDA077455 St Marys Medical Park Pharmacy BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 60760-495_151b2f26-714d-44cc-aecc-822e046e2697 60760-495 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20140123 ANDA ANDA078216 St Marys Medical Park Pharmacy CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60760-496_313e554a-f3af-4629-9103-f8ddb27c978b 60760-496 HUMAN PRESCRIPTION DRUG CITALOPRAM CITALOPRAM TABLET ORAL 20140523 ANDA ANDA077289 St Marys Medical Park Pharmacy CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 60760-512_1edbff71-3b78-4c24-b711-e4d1765a21b5 60760-512 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20140116 ANDA ANDA076639 St Marys Medical Park Pharmacy CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 60760-515_975290c1-d9f3-4294-bb30-85edb93a07f2 60760-515 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 St Marys Medical Park Pharmacy ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 60760-522_61343191-8c91-4efa-b5ba-b6c1d2cda5c9 60760-522 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20130808 ANDA ANDA076048 St Marys Medical Park Pharmacy OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 60760-535_85324c6c-1b63-450f-8a54-8fff548df661 60760-535 HUMAN PRESCRIPTION DRUG TRIAMTERENE and HYDROCHLOROTHIAZIDE TRIAMTERENE, HYDROCHLOROTHIAZIDE CAPSULE ORAL 20140421 ANDA ANDA201407 St Marys Medical Park Pharmacy HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60760-542_2f379749-e9c3-4f43-ac56-165ac3cc100f 60760-542 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20140130 ANDA ANDA075693 St Marys Medical Park Pharmacy IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 60760-546_7105455c-91e7-4834-99b1-66c1efac5d93 60760-546 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20140522 ANDA ANDA090686 St Marys Medical Park Pharmacy DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 60760-547_7105455c-91e7-4834-99b1-66c1efac5d93 60760-547 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20140522 ANDA ANDA090686 St Marys Medical Park Pharmacy DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 60760-551_8934ea0b-e385-4759-95c2-762029511572 60760-551 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20101201 NDA NDA021774 St Marys Medical Park Pharmacy ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 60760-600_4cb96f32-5e47-466e-9ae4-f349d5be4ead 60760-600 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130515 NDA AUTHORIZED GENERIC NDA018279 St Marys Medical Park Pharmacy POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 60760-601_28b4a808-0299-4bda-b8f9-cb255e868d23 60760-601 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE ORAL 20130516 ANDA ANDA076368 St Marys Medical Park Pharmacy . POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 60760-602_b33630dd-4305-49cb-bf34-d1c29f40b0af 60760-602 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140820 NDA NDA019123 St Marys Medical Park Pharmacy POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 60760-617_3f22309b-0c38-45c5-8368-0754ef0da67a 60760-617 HUMAN PRESCRIPTION DRUG Opana ER OXYMORPHONE HYDROCHLORIDE TABLET ORAL 20101231 NDA NDA021610 St Marys Medical Park Pharmacy OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60760-624_761948ab-7764-4940-b44c-0bd86f8df148 60760-624 HUMAN PRESCRIPTION DRUG FUROSEMIDE FUROSEMIDE TABLET ORAL 20130509 ANDA ANDA078010 St Marys Medical Park Pharmacy FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 60760-625_761948ab-7764-4940-b44c-0bd86f8df148 60760-625 HUMAN PRESCRIPTION DRUG FUROSEMIDE FUROSEMIDE TABLET ORAL 20130509 ANDA ANDA078010 St Marys Medical Park Pharmacy FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 60760-629_9ce44591-21f0-4a9e-8d64-084fb1ed4a3e 60760-629 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20130815 ANDA ANDA040256 St Marys Medical Park Pharmacy PREDNISONE 5 mg/1 60760-687_092120c9-7f98-4411-a0bc-e64dbd586ac9 60760-687 HUMAN PRESCRIPTION DRUG Lidoderm 5 LIDOCAINE LIQUID CUTANEOUS 20101221 NDA NDA020612 St Marys Medical Park Pharmacy LIDOCAINE 700 mg/1000mg Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 60760-695_8ae84355-1d8d-44b1-bb89-2cf096b1fbdb 60760-695 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE XL BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140522 ANDA ANDA077715 St Marys Medical Park Pharmacy BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 60760-735_aa6ea500-0600-4cd1-8a9c-14f2630db224 60760-735 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20140421 ANDA ANDA076999 St Marys Medical Park Pharmacy CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 60760-749_bd0ce4e7-869c-479e-84e3-38d71e90d8ab 60760-749 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20140522 ANDA ANDA040833 St Marys Medical Park Pharmacy ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 60760-760_08e1705d-5fbe-429f-9636-d60538eb92a2 60760-760 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20140523 ANDA ANDA077948 St Marys Medical Park Pharmacy HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60760-788_ebc7377c-b333-469a-a064-e4c3dc9df3e7 60760-788 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20140421 ANDA ANDA074514 St Marys Medical Park Pharmacy DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60760-792_4421b001-2fe0-4f21-8760-f8b706a1cc36 60760-792 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20130711 ANDA ANDA078558 St Marys Medical Park Pharmacy IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60760-795_2327becb-235e-48a4-8ea5-b227ae26ca89 60760-795 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19860730 ANDA ANDA085223 St. Mary's Medical Park Pharmacy DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 60760-812_359eca16-239f-4f7d-8050-57c193fa5dc2 60760-812 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20140523 ANDA ANDA073555 St Marys Medical Park Pharmacy NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 60760-817_4f9fbac6-34dd-4d8b-b5d6-5bc86c494fee 60760-817 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20140522 ANDA ANDA075491 St Marys Medical Park Pharmacy BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 60760-855_ff7c2a0b-d4b1-45b7-8069-6c42e797bccc 60760-855 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110111 ANDA ANDA076636 St Marys Medical Park Pharmacy OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60760-900_7364675a-c9ff-4059-873d-de67ce2736bb 60760-900 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE CAPSULE ORAL 20130502 ANDA ANDA075868 St Marys Medical Park Pharmacy FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 60760-901_71fa3d7f-da21-4a71-9bdc-374e04184f00 60760-901 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET, FILM COATED ORAL 20100201 ANDA ANDA076635 St Marys Medical Park Pharmacy FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 60760-902_d0933272-f46f-4b7e-8d11-158de05ddf2e 60760-902 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20140421 ANDA ANDA075868 St Marys Medical Park Pharmacy FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 60760-911_9d9198a0-28c2-4834-99f8-14d84b0a117c 60760-911 HUMAN PRESCRIPTION DRUG Fentanyl FENTANYL PATCH TRANSDERMAL 20110126 ANDA ANDA077062 St. Marys Medical Park Pharmacy FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60760-912_9d9198a0-28c2-4834-99f8-14d84b0a117c 60760-912 HUMAN PRESCRIPTION DRUG Fentanyl FENTANYL PATCH TRANSDERMAL 20110126 ANDA ANDA077062 St. Marys Medical Park Pharmacy FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60760-914_9d9198a0-28c2-4834-99f8-14d84b0a117c 60760-914 HUMAN PRESCRIPTION DRUG Fentanyl FENTANYL PATCH TRANSDERMAL 20110126 ANDA ANDA077062 St. Marys Medical Park Pharmacy FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60760-933_909ab0bd-bf16-4e1b-809f-5a91654ceebe 60760-933 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen OXYCODONE HYDROCHLORIDE, ACETAMINOPHEN TABLET ORAL 20101222 ANDA ANDA040545 St Marys Medical Park Pharmacy ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60760-973_51292421-721c-4760-a515-f44b1fc77020 60760-973 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130515 ANDA ANDA090564 St Marys Medical Park Pharmacy METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 60760-974_51292421-721c-4760-a515-f44b1fc77020 60760-974 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130515 ANDA ANDA090564 St Marys Medical Park Pharmacy METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 60760-975_51292421-721c-4760-a515-f44b1fc77020 60760-975 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130515 ANDA ANDA090564 St Marys Medical Park Pharmacy METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 60760-976_9734ae55-fbed-4a4e-9719-cd4728b49e68 60760-976 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130808 ANDA ANDA090615 St Marys Medical Park Pharmacy METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60760-977_bda47a0c-2aca-4f8d-a427-a5d9b935da49 60760-977 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE ORAL 20130808 ANDA ANDA090617 St Marys Medical Park Pharmacy METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60760-978_9734ae55-fbed-4a4e-9719-cd4728b49e68 60760-978 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130808 ANDA ANDA090615 St Marys Medical Park Pharmacy METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60760-980_1ecd7fd9-1072-4d70-89d4-b7c10034ef03 60760-980 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET ORAL 20130516 ANDA ANDA071655 St Marys Medical Park Pharmacy OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 60760-981_a69d30d1-bed5-49df-b9fa-c60a5522233d 60760-981 HUMAN PRESCRIPTION DRUG SPIRONOLACTONE SPIRONOLACTONE TABLET ORAL 20130522 ANDA ANDA089424 St Marys Medical Park Pharmacy SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 60760-982_b1b78bc5-3fe3-479a-8302-3f60fb3dda6d 60760-982 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130522 ANDA ANDA078938 St Marys Medical Park Pharmacy TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 60760-983_eade9ae7-02bd-4b7a-86c4-31d908fe9767 60760-983 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20130522 ANDA ANDA073449 St Marys Medical Park Pharmacy HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60760-984_e1b59298-47d1-4efd-8543-d99987220f36 60760-984 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130522 ANDA ANDA078906 St Marys Medical Park Pharmacy VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60760-985_0279394f-f3bf-408f-a9e4-e2ba1afde446 60760-985 HUMAN PRESCRIPTION DRUG Verapamil Verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130205 ANDA ANDA200878 St Marys Medical Park Pharmacy VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60760-986_44dd020f-2b0b-496a-ad37-567d4aeccc80 60760-986 HUMAN PRESCRIPTION DRUG VERAPAMIL Verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140421 ANDA ANDA200878 St Marys Medical Park Pharmacy VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 60764-001_14f5bdaf-bd15-435e-8822-b32226c730b5 60764-001 HUMAN OTC DRUG 3 CONCEPT EYES GLOSSING WATERFUL FOUNDATION MILK IVORY Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE 1.44 g/40g 60764-002_0d22c4b9-3a29-4bae-b4ea-9cb80d9840e8 60764-002 HUMAN OTC DRUG 3 CONCEPT EYES GLOSSING WATERFUL FOUNDATION NATURAL IVORY Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE 1.44 g/40g 60764-003_c3823aaa-5894-4096-a9dd-f0afff30df6b 60764-003 HUMAN OTC DRUG 3 CONCEPT EYES GLOSSING WATERFUL FOUNDATION NUDE BEIGE Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE 1.44 g/40g 60764-004_35a3eaa6-40d8-431c-8e4d-a2fa482e768f 60764-004 HUMAN OTC DRUG 3 CONCEPT EYES GLOSSING WATERFUL FOUNDATION SOFT BEIGE Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE 1.44 g/40g 60764-005_c8d714e3-482f-4247-b6bb-2e9acee943da 60764-005 HUMAN OTC DRUG 3 CONCEPT EYES HONEY FACE CHIFFON FLUID 001 Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE 3.71 mg/40mL 60764-006_ca8b90eb-db68-401a-a92f-80cc1c2dd81a 60764-006 HUMAN OTC DRUG 3 CONCEPT EYES HONEY FACE CHIFFON FLUID 002 Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE 3.71 mg/40mL 60764-007_0feb4cc7-5e70-42f7-ab82-97a8b2dc0b2d 60764-007 HUMAN OTC DRUG 3 CONCEPT EYES LIQUID FOUNDATION IVORY BEIGE Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE 2.78 mg/30mL 60764-008_02c8324d-627d-41f4-bcab-f59b06882737 60764-008 HUMAN OTC DRUG 3 CONCEPT EYES LIQUID FOUNDATION LACE BEIGE Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE 2.78 mg/30mL 60764-009_465cf293-f75f-4fa9-a06d-d512a0aef080 60764-009 HUMAN OTC DRUG 3 CONCEPT EYES SLIM FIT PACT NATURAL IVORY Titanium Dioxide POWDER TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE .57 g/8g 60764-010_21cc3ea3-e3b3-4333-96e1-aa7b64c8a4c1 60764-010 HUMAN OTC DRUG 3 CONCEPT EYES SLIM FIT PACT SOFT BEIGE Titanium Dioxide POWDER TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE .57 g/8g 60764-011_b3aa2f5a-c861-4b79-a873-08f41061efe2 60764-011 HUMAN OTC DRUG 3 CONCEPT EYES BACK TO BABY Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 1.5; 2.9 mg/30mL; mg/30mL 60768-001_7172de3d-c4db-41ba-863f-7e67839c089c 60768-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130919 UNAPPROVED MEDICAL GAS Gage Lucky 13 LLC dba Tecumseh Oxygen & Medical Supply OXYGEN 99 L/100L 60778-010_a81dcd31-a562-47ba-89e5-f9a5cfdcf0c1 60778-010 HUMAN OTC DRUG Lycoris Rubus brightening BB SPF40 PA Plus Plus OCTINOXATE, Titanium dioxide, Zinc oxide CREAM TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Lycoris Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 2; 2 mg/40mL; mg/40mL; mg/40mL 60778-020_404b5431-8780-4559-9e77-4b6a2f0c7472 60778-020 HUMAN OTC DRUG Lycoris rubus whitening moisturizing Allantoin CREAM TOPICAL 20130901 OTC MONOGRAPH FINAL part347 Lycoris Co., Ltd. ALLANTOIN .25 mg/50mL 60778-030_ec63cd50-1f4f-48aa-9aae-51df78b3c553 60778-030 HUMAN OTC DRUG Lycoris rubus whitening Allantoin CREAM TOPICAL 20130901 OTC MONOGRAPH FINAL part347 Lycoris Co., Ltd. ALLANTOIN .25 mg/50mL 60778-040_7b76a3f7-baa7-456b-9236-46ff4a385473 60778-040 HUMAN OTC DRUG Lycoris RUBUS Whitening Fluid Allantoin CREAM TOPICAL 20130901 OTC MONOGRAPH FINAL part347 Lycoris Co., Ltd. ALLANTOIN .67 mg/135mL 60779-001_7678385d-66dc-453f-b0c7-dae3236fa79d 60779-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20140101 UNAPPROVED MEDICAL GAS Latex Welding Supply Inc. dba ARC-La-Tec Welding Supply OXYGEN 99 L/100L 60781-1001_6b4b3173-a980-46d1-b0c7-a5287f2489a4 60781-1001 HUMAN OTC DRUG THINKSPORT sunscreen SPF 50 zinc oxide LOTION TOPICAL 20110101 OTC MONOGRAPH FINAL part352 thinkOperations,LLC ZINC OXIDE 200 mg/mL 60781-1002_17d27cc3-9334-4573-8b96-560d7b4d9668 60781-1002 HUMAN OTC DRUG THINKSPORT Kids sunscreen SPF 50 zinc oxide LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part352 thinkOperations,LLC ZINC OXIDE 200 mg/mL 60781-1003_90518e99-ff56-451c-bed2-d70ab45c42db 60781-1003 HUMAN OTC DRUG THINKBABY Baby Sunscreen SPF 50 zinc oxide LOTION TOPICAL 20130814 OTC MONOGRAPH FINAL part352 thinkOperations,LLC ZINC OXIDE 200 mg/mL 60781-1004_4691ec8c-a012-41e7-9ed8-278c0df19303 60781-1004 HUMAN OTC DRUG THINKSPORT LIVESTRONG SPF 50 zinc oxide LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part352 thinkOperations,LLC ZINC OXIDE 200 mg/mL 60782-000_bc35985e-98b8-489e-bf73-7b6f3bc466de 60782-000 HUMAN OTC DRUG Renove ROYAL PERFECT BB SPF 30 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20131003 OTC MONOGRAPH NOT FINAL part352 YS Health Corp. OCTINOXATE; TITANIUM DIOXIDE 30; 80 mg/mL; mg/mL 60782-001_9da7f217-7080-4886-a74f-4ad45d0a7c36 60782-001 HUMAN OTC DRUG Renove ROYAL PERFECT HAND Broad Spectrum SPF 15 ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, AVOBENZONE CREAM TOPICAL 20131205 OTC MONOGRAPH NOT FINAL part352 YS Health Corp. AVOBENZONE; OCTINOXATE; OCTISALATE 10; 68; 42 mg/g; mg/g; mg/g 60793-104_366a9c99-438a-4f45-8d03-582d78924023 60793-104 HUMAN PRESCRIPTION DRUG TAPAZOLE methimazole TABLET ORAL 20000331 ANDA ANDA040320 Pfizer Laboratories Div Pfizer Inc METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 60793-105_366a9c99-438a-4f45-8d03-582d78924023 60793-105 HUMAN PRESCRIPTION DRUG TAPAZOLE methimazole TABLET ORAL 20000331 ANDA ANDA040320 Pfizer Laboratories Div Pfizer Inc METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 60793-115_6fe21075-7002-4441-8938-2b1280f5355e 60793-115 HUMAN PRESCRIPTION DRUG Cytomel liothyronine sodium TABLET ORAL 19560508 NDA NDA010379 Pfizer Laboratories Div Pfizer Inc LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 60793-116_6fe21075-7002-4441-8938-2b1280f5355e 60793-116 HUMAN PRESCRIPTION DRUG Cytomel liothyronine sodium TABLET ORAL 19560508 NDA NDA010379 Pfizer Laboratories Div Pfizer Inc LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 60793-117_6fe21075-7002-4441-8938-2b1280f5355e 60793-117 HUMAN PRESCRIPTION DRUG Cytomel liothyronine sodium TABLET ORAL 19560508 NDA NDA010379 Pfizer Laboratories Div Pfizer Inc LIOTHYRONINE SODIUM 50 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 60793-130_047c1fcf-27b9-4902-b16e-7199fe577f24 60793-130 HUMAN PRESCRIPTION DRUG PENICILLIN G PROCAINE penicillin g procaine INJECTION, SUSPENSION INTRAMUSCULAR 19480426 ANDA ANDA060101 Pfizer Laboratories Div Pfizer Inc PENICILLIN G PROCAINE 600000 [iU]/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 60793-131_047c1fcf-27b9-4902-b16e-7199fe577f24 60793-131 HUMAN PRESCRIPTION DRUG PENICILLIN G PROCAINE penicillin g procaine INJECTION, SUSPENSION INTRAMUSCULAR 19480426 ANDA ANDA060101 Pfizer Laboratories Div Pfizer Inc PENICILLIN G PROCAINE 1200000 [iU]/2mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 60793-136_a4c8c2fd-e077-442e-bf82-f16034fb580f 60793-136 HUMAN PRESCRIPTION DRUG SKELAXIN metaxalone TABLET ORAL 20020830 NDA NDA013217 Pfizer Laboratories Div Pfizer Inc METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 60793-145_1630f04c-6d94-4fd7-b39d-d10229082d46 60793-145 HUMAN PRESCRIPTION DRUG Sonata zaleplon CAPSULE ORAL 19990813 NDA NDA020859 Pfizer Laboratories Div Pfizer Inc ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 60793-146_1630f04c-6d94-4fd7-b39d-d10229082d46 60793-146 HUMAN PRESCRIPTION DRUG Sonata zaleplon CAPSULE ORAL 19990813 NDA NDA020859 Pfizer Laboratories Div Pfizer Inc ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 60793-205_c7a69373-8751-4b3e-9d3d-fdedc420c5c8 60793-205 PLASMA DERIVATIVE THROMBIN-JMI thrombin, topical (bovine) KIT 19950224 BLA BLA102865 Pfizer Laboratories Div Pfizer Inc 60793-215_c7a69373-8751-4b3e-9d3d-fdedc420c5c8 60793-215 PLASMA DERIVATIVE THROMBIN-JMI thrombin, topical (bovine) KIT 19950224 BLA BLA102865 Pfizer Laboratories Div Pfizer Inc 60793-217_c7a69373-8751-4b3e-9d3d-fdedc420c5c8 60793-217 PLASMA DERIVATIVE THROMBIN-JMI thrombin, topical (bovine) KIT 19950224 BLA BLA102865 Pfizer Laboratories Div Pfizer Inc 60793-283_b460ad32-a557-495c-aa65-13ec28ac9ed1 60793-283 HUMAN PRESCRIPTION DRUG CORZIDE nadolol and bendroflumethiazide TABLET ORAL 19830525 NDA NDA018647 Pfizer Laboratories Div Pfizer Inc BENDROFLUMETHIAZIDE; NADOLOL 5; 40 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60793-284_b460ad32-a557-495c-aa65-13ec28ac9ed1 60793-284 HUMAN PRESCRIPTION DRUG CORZIDE nadolol and bendroflumethiazide TABLET ORAL 19830525 NDA NDA018647 Pfizer Laboratories Div Pfizer Inc BENDROFLUMETHIAZIDE; NADOLOL 5; 80 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 60793-411_139a2a73-1900-4475-8ab8-b496a89b4abd 60793-411 HUMAN PRESCRIPTION DRUG Flector Diclofenac Epolamine PATCH TOPICAL 20080114 NDA NDA021234 King Pharmaceuticals, Inc. DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 60793-430_c1650481-a5de-4c70-ba40-d80f8f0f3384 60793-430 HUMAN PRESCRIPTION DRUG EMBEDA MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20090813 NDA NDA022321 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 20; .8 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CII 60793-431_c1650481-a5de-4c70-ba40-d80f8f0f3384 60793-431 HUMAN PRESCRIPTION DRUG EMBEDA MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20090813 NDA NDA022321 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 30; 1.2 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CII 60793-433_c1650481-a5de-4c70-ba40-d80f8f0f3384 60793-433 HUMAN PRESCRIPTION DRUG EMBEDA MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20090813 NDA NDA022321 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 50; 2 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CII 60793-434_c1650481-a5de-4c70-ba40-d80f8f0f3384 60793-434 HUMAN PRESCRIPTION DRUG EMBEDA MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20090813 NDA NDA022321 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 60; 2.4 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CII 60793-435_c1650481-a5de-4c70-ba40-d80f8f0f3384 60793-435 HUMAN PRESCRIPTION DRUG EMBEDA MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20090813 NDA NDA022321 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 80; 3.2 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CII 60793-437_c1650481-a5de-4c70-ba40-d80f8f0f3384 60793-437 HUMAN PRESCRIPTION DRUG EMBEDA MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20090813 NDA NDA022321 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 100; 4 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CII 60793-525_62a67736-7354-4eec-8c3e-1f5743594f21 60793-525 HUMAN PRESCRIPTION DRUG OXECTA OXYCODONE HYDROCHLORIDE TABLET ORAL 20110617 NDA NDA202080 Pfizer Laboratories Div Pfizer Inc OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60793-526_62a67736-7354-4eec-8c3e-1f5743594f21 60793-526 HUMAN PRESCRIPTION DRUG OXECTA OXYCODONE HYDROCHLORIDE TABLET ORAL 20110617 NDA NDA202080 Pfizer Laboratories Div Pfizer Inc OXYCODONE HYDROCHLORIDE 7.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60793-600_7eefef61-058e-43d1-bfb6-45aa4de9fe9a 60793-600 HUMAN PRESCRIPTION DRUG BICILLIN CR penicillin G benzathine and penicillin G procaine INJECTION, SUSPENSION INTRAMUSCULAR 19530518 NDA NDA050138 Pfizer Laboratories Div Pfizer Inc PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE 600000; 600000 [iU]/2mL; [iU]/2mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 60793-601_7eefef61-058e-43d1-bfb6-45aa4de9fe9a 60793-601 HUMAN PRESCRIPTION DRUG BICILLIN CR penicillin G benzathine and penicillin G procaine INJECTION, SUSPENSION INTRAMUSCULAR 19530518 NDA NDA050138 Pfizer Laboratories Div Pfizer Inc PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE 600000; 600000 [iU]/2mL; [iU]/2mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 60793-602_354528f2-4885-44a4-b039-3cabad011c8b 60793-602 HUMAN PRESCRIPTION DRUG BICILLIN C-R 900/300 penicillin G benzathine and penicillin G procaine INJECTION, SUSPENSION INTRAMUSCULAR 19530518 NDA NDA050138 Pfizer Laboratories Div Pfizer Inc PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE 900000; 300000 [iU]/2mL; [iU]/2mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 60793-603_83cbf1f1-b451-4d8c-8242-e2ca6bbf2e46 60793-603 HUMAN PRESCRIPTION DRUG AVINZA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20020320 NDA NDA021260 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE 45 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60793-604_83cbf1f1-b451-4d8c-8242-e2ca6bbf2e46 60793-604 HUMAN PRESCRIPTION DRUG AVINZA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20020320 NDA NDA021260 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE 75 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60793-605_83cbf1f1-b451-4d8c-8242-e2ca6bbf2e46 60793-605 HUMAN PRESCRIPTION DRUG AVINZA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20020320 NDA NDA021260 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60793-606_83cbf1f1-b451-4d8c-8242-e2ca6bbf2e46 60793-606 HUMAN PRESCRIPTION DRUG AVINZA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20020320 NDA NDA021260 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60793-607_83cbf1f1-b451-4d8c-8242-e2ca6bbf2e46 60793-607 HUMAN PRESCRIPTION DRUG AVINZA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20020320 NDA NDA021260 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE 90 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60793-608_83cbf1f1-b451-4d8c-8242-e2ca6bbf2e46 60793-608 HUMAN PRESCRIPTION DRUG AVINZA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20020320 NDA NDA021260 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE 120 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60793-700_c858eee8-bc67-4881-87fb-87af0d057b97 60793-700 HUMAN PRESCRIPTION DRUG BICILLIN L-A penicillin G benzathine INJECTION, SUSPENSION INTRAMUSCULAR 19520627 NDA NDA050141 Pfizer Laboratories Div Pfizer Inc PENICILLIN G BENZATHINE 600000 [iU]/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 60793-701_c858eee8-bc67-4881-87fb-87af0d057b97 60793-701 HUMAN PRESCRIPTION DRUG BICILLIN L-A penicillin G benzathine INJECTION, SUSPENSION INTRAMUSCULAR 19520627 NDA NDA050141 Pfizer Laboratories Div Pfizer Inc PENICILLIN G BENZATHINE 1200000 [iU]/2mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 60793-702_c858eee8-bc67-4881-87fb-87af0d057b97 60793-702 HUMAN PRESCRIPTION DRUG BICILLIN L-A penicillin G benzathine INJECTION, SUSPENSION INTRAMUSCULAR 19520627 NDA NDA050141 Pfizer Laboratories Div Pfizer Inc PENICILLIN G BENZATHINE 2400000 [iU]/4mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 60793-705_c7a69373-8751-4b3e-9d3d-fdedc420c5c8 60793-705 PLASMA DERIVATIVE THROMBIN-JMI thrombin, topical (bovine) KIT 19950224 BLA BLA102865 Pfizer Laboratories Div Pfizer Inc 60793-800_15c2b40b-81b9-404a-9d49-b30498c8d3ef 60793-800 HUMAN PRESCRIPTION DRUG CORGARD nadolol TABLET ORAL 19791210 NDA NDA018063 Pfizer Laboratories Div Pfizer Inc NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60793-801_15c2b40b-81b9-404a-9d49-b30498c8d3ef 60793-801 HUMAN PRESCRIPTION DRUG CORGARD nadolol TABLET ORAL 19791210 NDA NDA018063 Pfizer Laboratories Div Pfizer Inc NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60793-802_15c2b40b-81b9-404a-9d49-b30498c8d3ef 60793-802 HUMAN PRESCRIPTION DRUG CORGARD nadolol TABLET ORAL 19791210 NDA NDA018063 Pfizer Laboratories Div Pfizer Inc NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 60793-850_08c86bc8-2917-4e56-b87d-1ddb73ce507f 60793-850 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60793-851_08c86bc8-2917-4e56-b87d-1ddb73ce507f 60793-851 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60793-852_08c86bc8-2917-4e56-b87d-1ddb73ce507f 60793-852 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60793-853_08c86bc8-2917-4e56-b87d-1ddb73ce507f 60793-853 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60793-854_08c86bc8-2917-4e56-b87d-1ddb73ce507f 60793-854 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60793-855_08c86bc8-2917-4e56-b87d-1ddb73ce507f 60793-855 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60793-856_08c86bc8-2917-4e56-b87d-1ddb73ce507f 60793-856 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60793-857_08c86bc8-2917-4e56-b87d-1ddb73ce507f 60793-857 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60793-858_08c86bc8-2917-4e56-b87d-1ddb73ce507f 60793-858 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60793-859_08c86bc8-2917-4e56-b87d-1ddb73ce507f 60793-859 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60793-860_08c86bc8-2917-4e56-b87d-1ddb73ce507f 60793-860 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60808-000_2ff12a05-3528-45a1-b57f-9ba37e123be2 60808-000 HUMAN OTC DRUG EZ PAIN RELIEVING Lidocaine HCl CREAM TOPICAL 20131106 OTC MONOGRAPH NOT FINAL part348 E2 Brokers Inc. LIDOCAINE HYDROCHLORIDE 4 mg/mL 60809-166_990f47f3-a08a-496a-b0c0-ae7193a11b01 60809-166 HUMAN PRESCRIPTION DRUG Migergot ergotamine tartrate and caffeine SUPPOSITORY RECTAL 20141001 ANDA ANDA086557 Crealta Pharmaceuticals LLC CAFFEINE; ERGOTAMINE TARTRATE 100; 2 mg/1; mg/1 Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 60809-801_040996af-3ad5-43fd-a446-87dac2c7fb39 60809-801 HUMAN PRESCRIPTION DRUG Krystexxa pegloticase INJECTION, SOLUTION INTRAVENOUS 20100914 BLA BLA125293 Crealta Pharmaceuticals LLC PEGLOTICASE 8 mg/mL Urate Oxidase [Chemical/Ingredient],Uric Acid-specific Enzyme [EPC] 60840-0100_a8ad7c28-7e88-8547-95c3-c840a6b2fd5b 60840-0100 HUMAN OTC DRUG Libera Tos Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20131101 OTC MONOGRAPH FINAL part341 RockHealth, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 60840-0200_d91b4832-d7d8-4485-8491-714e3de35e81 60840-0200 HUMAN OTC DRUG Libera Tos Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20131101 OTC MONOGRAPH FINAL part341 RockHealth, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 60840-0300_49130127-464d-494f-3241-0bafe28af2df 60840-0300 HUMAN OTC DRUG Libera Tos Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20131101 OTC MONOGRAPH FINAL part341 RockHealth, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 75 mg/5mL; mg/5mL 60842-030_87e9c108-be88-11e3-b1b6-0800200c9a66 60842-030 HUMAN PRESCRIPTION DRUG Evzio naloxone hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20140403 NDA NDA205787 kaleo, Inc. NALOXONE HYDROCHLORIDE .4 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] 60846-517_30d9f91c-cdbd-4423-9c32-3b188dcb80ab 60846-517 HUMAN PRESCRIPTION DRUG Pyridium Phenazopyridine TABLET, FILM COATED ORAL 20110201 UNAPPROVED DRUG OTHER Gemini Laboratories, LLC PHENAZOPYRIDINE 100 mg/1 60846-520_30d9f91c-cdbd-4423-9c32-3b188dcb80ab 60846-520 HUMAN PRESCRIPTION DRUG Pyridium Phenazopyridine TABLET, FILM COATED ORAL 20110201 UNAPPROVED DRUG OTHER Gemini Laboratories, LLC PHENAZOPYRIDINE 200 mg/1 60846-801_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-801 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60846-802_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-802 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60846-803_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-803 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60846-804_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-804 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60846-805_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-805 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60846-806_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-806 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60846-807_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-807 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60846-808_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-808 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60846-809_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-809 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60846-810_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-810 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60846-811_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-811 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60846-812_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-812 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 300 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 60846-900_2749cb59-4d46-4b92-90a6-58131a0da872 60846-900 HUMAN PRESCRIPTION DRUG REPREXAIN Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 20131227 ANDA ANDA076642 Gemini Laboratories, LLC HYDROCODONE BITARTRATE; IBUPROFEN 2.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 60846-901_2749cb59-4d46-4b92-90a6-58131a0da872 60846-901 HUMAN PRESCRIPTION DRUG REPREXAIN Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 20131227 ANDA ANDA076642 Gemini Laboratories, LLC HYDROCODONE BITARTRATE; IBUPROFEN 5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 60846-902_2749cb59-4d46-4b92-90a6-58131a0da872 60846-902 HUMAN PRESCRIPTION DRUG REPREXAIN Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 20131227 ANDA ANDA076642 Gemini Laboratories, LLC HYDROCODONE BITARTRATE; IBUPROFEN 10; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 60858-314_443b29d5-edb3-4213-8109-9cf2b1729111 60858-314 HUMAN OTC DRUG END-ITCH oatmeal CREAM TOPICAL 20140106 OTC MONOGRAPH FINAL part347 Crystal Connections, LLC OATMEAL .0287 g/g 60867-100_86913b70-8162-44fb-baee-e92d7c20f16e 60867-100 HUMAN OTC DRUG safeHands Benzalkonium Chloride LIQUID TOPICAL 20140927 OTC MONOGRAPH NOT FINAL part333A safeHands LLC BENZALKONIUM CHLORIDE .13 g/100mL 60867-101_c6c02448-eb63-4f65-9200-4673d6bf62b8 60867-101 HUMAN OTC DRUG safeHands Benzalkonium chloride LIQUID TOPICAL 20140927 OTC MONOGRAPH NOT FINAL part333A safeHands LLC BENZALKONIUM CHLORIDE .13 g/100mL 60867-102_21249559-395e-4225-ae22-a97888201912 60867-102 HUMAN OTC DRUG safeHands Benzalkonium chloride LIQUID TOPICAL 20140927 OTC MONOGRAPH NOT FINAL part333A safeHands LLC BENZALKONIUM CHLORIDE .13 g/100mL 60867-103_4ccce158-4854-4d0d-89da-cb8262275e6e 60867-103 HUMAN OTC DRUG safeHands Squirts Benzalkonium chloride LIQUID TOPICAL 20140927 OTC MONOGRAPH NOT FINAL part333A safeHands LLC BENZALKONIUM CHLORIDE .13 g/100mL 60867-104_2bc1fb37-5e5d-46ca-b321-f54c446e9bb6 60867-104 HUMAN OTC DRUG safeHands Squirts Benzalkonium chloride LIQUID TOPICAL 20140927 OTC MONOGRAPH NOT FINAL part333A safeHands LLC BENZALKONIUM CHLORIDE .13 g/100mL 60867-105_4d0de7b6-7673-47b8-9a18-d5551bb1f8a1 60867-105 HUMAN OTC DRUG safeHands Squirts Benzalkonium chloride LIQUID TOPICAL 20140927 OTC MONOGRAPH NOT FINAL part333A safeHands LLC BENZALKONIUM CHLORIDE .13 g/100mL 60875-100_9bc8f6fc-ecbc-4269-86ae-ce0de8184266 60875-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100524 UNAPPROVED MEDICAL GAS Jim's Pharmacy OXYGEN 992 mL/L 60881-555_eb790611-1402-415e-9062-dff11826dbdd 60881-555 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19880101 UNAPPROVED MEDICAL GAS Allen Medical, Inc OXYGEN 99 L/100L 60892-601_f290a608-92ee-49e0-957e-b67f1006f489 60892-601 HUMAN OTC DRUG TriLipiderm Broad Spectrum SPF 30 Butyl Methoxydibenzoylmethane, Ethylhexyl methoxycinnamate, Homosalate, Octocrylene CREAM TOPICAL 20140131 OTC MONOGRAPH FINAL part352 TriLipid Research Institute, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3; 10; 7.5; 2.7 g/100mL; g/100mL; g/100mL; g/100mL 60899-010_7262e2eb-e7de-452c-81d3-f6f64603465a 60899-010 HUMAN OTC DRUG Seaweed Aqua Massage Allantoin CREAM TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. ALLANTOIN 1.5 g/300g 60899-020_2bf5bb8b-96b2-4057-bf16-3ed7b8473519 60899-020 HUMAN OTC DRUG Nano Gold Bio Mask Pack Allantoin PATCH TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. ALLANTOIN .17 mg/35mL 60899-030_4b22428c-d4f4-4948-8cbd-1a33e24ac4d5 60899-030 HUMAN OTC DRUG Camellia Multiaction UV Sun Serum Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 AMAROS CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 1.4; 1.88 mg/40mL; mg/40mL 60899-040_2c4505e8-c145-480c-a1a6-c780261a3a53 60899-040 HUMAN OTC DRUG OHL O2 Allantoin SPRAY TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. ALLANTOIN .3 mg/60mL 60899-050_c9794724-eccb-43bf-967a-ce7477d13e25 60899-050 HUMAN OTC DRUG Seaweed Cleansing Mineral Oil LIQUID TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. MINERAL OIL 75 mg/150mL 60899-060_b15871aa-0139-4f2c-a9b8-a836099f988a 60899-060 HUMAN OTC DRUG Herbal Skin Toner Allantoin CREAM TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. ALLANTOIN .75 mg/150mL 60899-070_63ff976c-af90-4ce7-9375-c17104b807a3 60899-070 HUMAN OTC DRUG NoblRose Foam Cleanser Allantoin LIQUID TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. ALLANTOIN .75 mg/150mL 60899-080_0cd2cb88-fc95-4881-abc4-d61cfe77bfbc 60899-080 HUMAN OTC DRUG Acne Lab Foam Cleanser Salicylic acid LIQUID TOPICAL 20130901 OTC MONOGRAPH FINAL part333D AMAROS CO., LTD. SALICYLIC ACID .75 mg/150mL 60899-090_ce6e208a-ccc1-45bb-ba32-c5ea97da4486 60899-090 HUMAN OTC DRUG Vital Fluid IV Nano Gold Serum Allantoin CREAM TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. ALLANTOIN .15 mg/30mL 60899-100_e950e196-d09e-4ad0-8a1e-9d05f23f7037 60899-100 HUMAN OTC DRUG Vital Fluid II EGF and FGF Whitening Serum Allantoin CREAM TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. ALLANTOIN .15 mg/30mL 60899-110_268b1884-aef4-48cd-8c3e-0f8f2f2baafe 60899-110 HUMAN OTC DRUG Vital Fluid I Platinum Anti Wrinkle Serum Allantoin CREAM TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. ALLANTOIN .15 mg/30mL 60900-555_1fc33789-c0fc-4aa9-b865-2690af27f544 60900-555 HUMAN OTC DRUG Re-Gro minoxidil SOLUTION TOPICAL 20140401 ANDA ANDA074588 Empress Hair Products, Ltd. MINOXIDIL 2 g/100mL 60905-0000_13532cef-a4ae-4db9-a62b-3f10b44bb19b 60905-0000 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Linen Tint 0 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120707 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 2.997; 3.16 mL/100mL; mL/100mL 60905-0001_b23d4504-bcb7-4691-9f3c-7233db331ba6 60905-0001 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Ivory Tint 1 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 2.997; 3.16 mL/100mL; mL/100mL 60905-0002_86287e76-1493-46ac-98d8-33d9919e05bf 60905-0002 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Petal Tint 2 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120706 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 2.997; 3.16 mL/100mL; mL/100mL 60905-0003_cc3c85d2-99b7-4b1d-a8d3-e68a2383d7ec 60905-0003 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Sand Tint 3 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 2.997; 3.16 mL/100mL; mL/100mL 60905-0004_d880f45d-d194-464b-a08b-14814da15c20 60905-0004 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Vanilla Tint 4 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 2.997; 3.16 mL/100mL; mL/100mL 60905-0005_85b34f53-9884-4d68-95dd-ff39dd082afd 60905-0005 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Praline Tint 5 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 2.997; 3.16 mL/100mL; mL/100mL 60905-0006_a5b436a0-5fd5-4528-ae96-f625d7ac6e02 60905-0006 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Honey Tint 6 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 2.997; 3.16 mL/100mL; mL/100mL 60905-0007_dbdd62a2-c75d-40f3-83ae-8bf91bc15fc9 60905-0007 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Gold Tint 7 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 2.997; 3.16 mL/100mL; mL/100mL 60905-0008_bf81d284-fad9-4598-b070-26bae4b948c5 60905-0008 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Amber Tint 8 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 2.997; 3.16 mL/100mL; mL/100mL 60905-0009_43fee3e7-8ea2-4b21-acf1-28bb3a7ddcdb 60905-0009 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Spice Tint 9 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 2.997; 3.16 mL/100mL; mL/100mL 60905-0010_b070d294-0e14-47d6-a89a-f2c5abd83abf 60905-0010 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation Broad Spectrum SPF 20 Perfect Beige TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20121220 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 29.97; 31.6 mg/mL; mg/mL 60905-0011_8e299749-29fd-4e88-8f1f-cb7d7d222cd1 60905-0011 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation Broad Spectrum SPF 20 Perfect Cinnamon TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20121220 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 29.97; 31.6 mg/mL; mg/mL 60905-0012_2a3a9166-e3d4-4cd7-a9e0-4f3738bfe431 60905-0012 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation Broad Spectrum SPF 20 Perfect Almond TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20121220 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 29.97; 31.6 mg/mL; mg/mL 60905-0020_7fd9c0f8-2e40-4bc7-a7aa-e8dfa43bf85f 60905-0020 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT PORCELAIN TITANIUM DIOXIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL 60905-0021_8df0942e-8f98-4439-8646-48261a5fd4b6 60905-0021 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT SHELL TITANIUM DIOXIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL 60905-0022_d096fbeb-76c7-4aee-a41a-7a8c58688b59 60905-0022 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT SAND TITANIUM DIOXIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL 60905-0023_e3f37603-45d3-4cd0-afc9-b7341d5cd2c9 60905-0023 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT BEIGE TITANIUM DIOXIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL 60905-0024_a00d552b-bd29-431e-add0-148cc15958ac 60905-0024 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT HONEY TITANIUM DIOXIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL 60905-0025_414a9d6b-d0d2-4b9d-9837-a2f34c718fc3 60905-0025 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT GOLD TITANIUM DIOXIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL 60905-0026_c27430cb-8b96-4edd-bd62-2cbc8c11ac09 60905-0026 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT GINGER TITANIUM DIOXIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL 60905-0027_a7b8e090-05be-4b1c-8b0a-10ef89dc1ff6 60905-0027 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT AMBER TITANIUM DIOXIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL 60905-0028_372c8256-76a0-49f6-8edc-82022ca93d25 60905-0028 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT BROWN TITANIUM DIOXIDE LIQUID TOPICAL 20140612 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL 60905-0029_b971aade-cd5d-45b1-b0b7-2ffc58e9488f 60905-0029 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT SIENNA TITANIUM DIOXIDE LIQUID TOPICAL 20140612 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL 60905-0030_f5408cf8-1e0b-45d4-9459-8c840df0f603 60905-0030 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT VANILLA TITANIUM DIOXIDE LIQUID TOPICAL 20140612 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL 60905-0106_c51cfd82-e66b-4ec1-8f23-e9b30b27cfc6 60905-0106 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 106 Perfect Pecan TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20100721 OTC MONOGRAPH FINAL part352 Parfums Givenchy S.A. OCTINOXATE; TITANIUM DIOXIDE 29.97; 31.6 mg/mL; mg/mL 60905-0401_83d4102c-1f4a-4a95-989d-0ce296d96a8f 60905-0401 HUMAN OTC DRUG Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 1 TITANIUM DIOXIDE LIQUID TOPICAL 20110623 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 3.16 mL/100mL 60905-0402_62efd97e-26e3-4696-ae1c-bf87e516b6f2 60905-0402 HUMAN OTC DRUG Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 2 TITANIUM DIOXIDE LIQUID TOPICAL 20110623 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 3.16 mL/100mL 60905-0403_00777b52-0e0e-44fc-9a13-b81b69f75ea1 60905-0403 HUMAN OTC DRUG Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 3 TITANIUM DIOXIDE LIQUID TOPICAL 20110623 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 3.16 mL/100mL 60905-0404_5a8a15ae-5a8f-4bf3-8a12-e3ee58ea5c7d 60905-0404 HUMAN OTC DRUG Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 4 TITANIUM DIOXIDE LIQUID TOPICAL 20110623 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 3.16 mL/100mL 60905-0405_58644329-416e-4561-b999-a1a57b44a173 60905-0405 HUMAN OTC DRUG Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 5 TITANIUM DIOXIDE LIQUID TOPICAL 20110623 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 3.16 mL/100mL 60905-0406_8e28f124-469d-460c-aa8e-cd92a75f441d 60905-0406 HUMAN OTC DRUG Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 6 TITANIUM DIOXIDE LIQUID TOPICAL 20110623 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 3.16 mL/100mL 60905-0407_03f33072-6903-48bd-aa83-590a12d6a5ac 60905-0407 HUMAN OTC DRUG Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 7 TITANIUM DIOXIDE LIQUID TOPICAL 20110623 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 3.16 mL/100mL 60905-0408_aca1a8b6-fdb2-4476-95cd-15e431df3013 60905-0408 HUMAN OTC DRUG Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 8 TITANIUM DIOXIDE LIQUID TOPICAL 20110623 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 3.16 mL/100mL 60913-006_a77c5af3-4412-4a9c-9f61-5a778c9d6134 60913-006 HUMAN OTC DRUG Alcohol Prep Pads Isopropyl Alcohol SWAB TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part333A PHOENIX HEALTHCARE SOLUTIONS, LLC ISOPROPYL ALCOHOL 70 mL/100mL 60913-007_721305b9-51a7-475a-b5bd-d9df7c2d4978 60913-007 HUMAN OTC DRUG Alcohol Prep Pads Isopropyl Alcohol SWAB TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part333A PHOENIX HEALTHCARE SOLUTIONS, LLC ISOPROPYL ALCOHOL 70 mL/100mL 60913-008_9c201307-c4c5-47ef-8c3c-007076513f42 60913-008 HUMAN OTC DRUG Alcohol Prep Pads Isopropyl Alcohol SWAB TOPICAL 20141105 OTC MONOGRAPH NOT FINAL part333A PHOENIX HEALTHCARE SOLUTIONS, LLC ISOPROPYL ALCOHOL 70 mL/100mL 60913-009_7da615b7-edcd-454b-bcc1-9823c44f393b 60913-009 HUMAN OTC DRUG PHOENIX HEALTHCARE SOLUTIONS, LLC Isopropyl Alcohol SWAB TOPICAL 20131212 OTC MONOGRAPH FINAL part344 PHOENIX HEALTHCARE SOLUTIONS, LLC ISOPROPYL ALCOHOL 70 g/100g 60913-010_6488478f-f72b-40e3-ba72-0e7a96cfc2bb 60913-010 HUMAN OTC DRUG PHOENIX HEALTHCARE SOLUTIONS, LLC Isopropyl Alcohol SWAB TOPICAL 20131212 OTC MONOGRAPH FINAL part344 PHOENIX HEALTHCARE SOLUTIONS, LLC ISOPROPYL ALCOHOL 70 g/100g 60913-017_dd8790ac-b9b9-48db-af11-973890a8bc97 60913-017 HUMAN OTC DRUG Alcohol Prep Pads Isopropyl Alcohol SWAB TOPICAL 20131121 OTC MONOGRAPH NOT FINAL part333A PHOENIX HEALTHCARE SOLUTIONS, LLC ISOPROPYL ALCOHOL 70 mL/100mL 60913-018_0655943f-0472-4991-8fb8-08fdb323173a 60913-018 HUMAN OTC DRUG PHOENIX HEALTHCARE SOLUTIONS, LLC Isopropyl Alcohol SWAB TOPICAL 20131212 OTC MONOGRAPH FINAL part344 PHOENIX HEALTHCARE SOLUTIONS, LLC ISOPROPYL ALCOHOL 70 g/100g 60913-031_484bc723-a2fa-4493-9adb-3439d0f552d5 60913-031 HUMAN OTC DRUG PHOENIX HEALTHCARE SOLUTIONS, LLC Sting and Bite Benzocaine,Isopropyl Alcohol SWAB TOPICAL 20140806 OTC MONOGRAPH NOT FINAL part348 PHOENIX HEALTHCARE SOLUTIONS, LLC BENZOCAINE; ISOPROPYL ALCOHOL 6; 70 g/100g; g/100g 60913-999_fbba9969-ab4f-47fc-bfc0-505e9d19d470 60913-999 HUMAN OTC DRUG PHOENIX HEALTHCARE SOLUTIONS, LLC Povidone Iodine SWAB TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part333A PHOENIX HEALTHCARE SOLUTIONS, LLC POVIDONE-IODINE 10 g/100g 60914-001_03e4f66f-da1c-1d6f-e054-00144ff8d46c 60914-001 HUMAN OTC DRUG Soothing First Aid Cream Soothing First Aid Cream CREAM TOPICAL 20140922 UNAPPROVED HOMEOPATHIC Homeo Health, Inc. ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM; LYTTA VESICATORIA 4; 1; 6; 5; 1; 5 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 60916-001_4d28d68d-0793-4f45-9dbf-ce38cede000c 60916-001 HUMAN OTC DRUG Migranade Chamomilla, Natrum Sulphuricum, Sanguinaria Canadensis, Glutathione SPRAY NASAL 20140127 UNAPPROVED HOMEOPATHIC Migranade Inc. CHAMOMILE; GLUTATHIONE; SANGUINARIA CANADENSIS ROOT; SODIUM SULFATE 3; 1; 3; 3 [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL 60916-002_35f22641-b925-480b-9dd3-b1c91181648c 60916-002 HUMAN OTC DRUG Migranade Chamomilla, Natrum Sulphuricum, Sanguinaria Canadensis, Glutathione TABLET ORAL 20140801 UNAPPROVED HOMEOPATHIC Migranade Inc. CHAMOMILE; GLUTATHIONE; SANGUINARIA CANADENSIS ROOT; SODIUM SULFATE 3; 1; 3; 3 [hp_C]/3g; [hp_C]/3g; [hp_C]/3g; [hp_C]/3g 60919-1073_c0918fae-0583-446e-bcbd-29946a71378f 60919-1073 HUMAN PRESCRIPTION DRUG Liquid Oxygen Liquid Oxygen GAS RESPIRATORY (INHALATION) 20131205 UNAPPROVED MEDICAL GAS Hospice Express, Inc. OXYGEN 995 mL/L 60927-115_de02462d-3131-4934-801e-c120688b06f3 60927-115 HUMAN OTC DRUG Smarth Extra Strength Baking Soda Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20131201 OTC MONOGRAPH FINAL part355 Carib Sales, LLC SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 60927-116_8cd7c69c-0b93-4bd4-9643-ec63c386d89f 60927-116 HUMAN OTC DRUG Smarth Extra Strength Minty Fresh Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20131201 OTC MONOGRAPH FINAL part355 Carib Sales, LLC SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 60927-117_a523849e-cf74-4e0d-b055-918e23dc5f91 60927-117 HUMAN OTC DRUG SMARTH Extra Strength REGULAR SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20131201 OTC MONOGRAPH FINAL part355 Carib Sales, LLC SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 60927-118_055490e3-e4be-45d5-a1cf-c30a06ba8c42 60927-118 HUMAN OTC DRUG Smarth Extra Strength Whitening Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20131201 OTC MONOGRAPH FINAL part355 Carib Sales, LLC SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 60931-001_07ae7688-ec7d-4f44-9fa1-0475ab76d8f3 60931-001 HUMAN OTC DRUG Youduo Gentle Whitening Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20131031 OTC MONOGRAPH FINAL part355 Yangzhou Holyshine Industrial Co., Ltd. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 60934-001_fcd44cca-d91c-48ca-874c-8b08c6eb6724 60934-001 HUMAN OTC DRUG HydroPeptide Solar Defense Broad Spectrum SPF30 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20141225 OTC MONOGRAPH NOT FINAL part352 Premier HealthSource, Inc. TITANIUM DIOXIDE; ZINC OXIDE 25; 60 mg/mL; mg/mL 60943-010_5b461544-09be-4a86-9500-be7843b3d815 60943-010 HUMAN OTC DRUG KICHO CC OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part352 DOOYEON CORPORATION OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; .7; 2.03; .67 mg/35mL; mg/35mL; mg/35mL; mg/35mL 60949-010_0b59bb23-7535-402c-a5c2-f6d47158dc74 60949-010 HUMAN OTC DRUG By Pharmicell Lab The Prestige GLYCERIN CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. GLYCERIN 10 g/50g 60949-020_87154bb0-de2b-4d33-8ad7-532b5963294d 60949-020 HUMAN OTC DRUG By Pharmicell Lab The Prestige Essence ALLANTOIN CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .22 mg/45mL 60949-030_3b9ed51d-50fe-4335-89a7-d4b999be1048 60949-030 HUMAN OTC DRUG By Pharmicell Lab Prestige Sun Block SPF40 PA PLUS PLUS PLUS OCTINOXATE, OCTISALATE, ENSULIZOLE, AVOBENZONE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Pharmicell Co., Ltd. AVOBENZONE; ENSULIZOLE; OCTINOXATE; OCTISALATE 1.5; 2; 2.75; 2.5 g/50g; g/50g; g/50g; g/50g 60949-040_1b6cb178-e94e-4b6c-b497-dc8c9f5ddbf6 60949-040 HUMAN OTC DRUG By Pharmicell Lab Prestige BB SPF30 PA PLUS PLUS TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Pharmicell Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 5.22; .72 g/50g; g/50g 60949-050_8b3e5f45-ff20-4884-a829-ca03f1332034 60949-050 HUMAN OTC DRUG By Pharmicell Lab Luxury Cell Performance DIMETHICONE CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. DIMETHICONE .5 g/50g 60949-060_a51869fd-48b9-405a-ba25-f1328ca35372 60949-060 HUMAN OTC DRUG By Pharmicell Lab Luxury Cell Performance Emulsion ALLANTOIN CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .65 mg/130mL 60949-070_46e267a3-dfd3-441b-be8b-4c9ffc2b9324 60949-070 HUMAN OTC DRUG By Pharmicell Lab Luxury Cell Performance Eye DIMETHICONE CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. DIMETHICONE .6 g/20g 60949-080_755a3314-b4aa-4619-bc40-698a466e5dda 60949-080 HUMAN OTC DRUG By Pharmicell Lab Luxury Cell Performance Serum ALLANTOIN CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .225 mg/45mL 60949-090_f09e4bf2-1147-4c1d-8e3d-06dee3541ee7 60949-090 HUMAN OTC DRUG By Pharmicell Lab Luxury Cell Performance Toner ALLANTOIN CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .65 mg/130mL 60949-100_1c8c2dfa-376c-4a14-b4ef-6744402a7033 60949-100 HUMAN OTC DRUG By Pharmicell Lab Moisturizing Face Toning Mist ALLANTOIN SPRAY TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .6 mg/120mL 60949-110_b98f36fc-f9da-4699-b2cc-88c7dc1076cc 60949-110 HUMAN OTC DRUG By Pharmicell Lab Beaucell Dual Hydrogel Mask GLYCERIN PATCH TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. GLYCERIN 9 g/51 60949-120_bb45083d-2605-4cdf-b25a-feba2456d2dd 60949-120 HUMAN OTC DRUG Luxury Cell Performance Toner ALLANTOIN CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .65 mg/130mL 60949-130_74318e49-75c9-4d0a-a2d3-bce48ca030fb 60949-130 HUMAN OTC DRUG Luxury Cell Performance Emulsion ALLANTOIN CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .65 mg/130mL 60949-140_1e7d20a0-cc90-47d2-9926-82cbbee8bf7c 60949-140 HUMAN OTC DRUG Luxury Cell Performance Serum ALLANTOIN CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .22 mg/45mL 60949-150_f912f2ce-3a52-4da2-a176-7be588c117af 60949-150 HUMAN OTC DRUG Luxury Cell Performance Eye DIMETHICONE CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. DIMETHICONE .6 g/20g 60949-160_cd227d1c-f94e-4ba0-ab36-ed2dd23f8881 60949-160 HUMAN OTC DRUG Luxury Cell Performance DIMETHICONE CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. DIMETHICONE .5 g/50g 60949-170_64c38752-06e5-400c-a95d-272fcae7df5e 60949-170 HUMAN OTC DRUG The Prestige Essence ALLANTOIN CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .22 mg/45mL 60949-180_7b1ea48d-d4f3-4116-95a3-8502305d8c85 60949-180 HUMAN OTC DRUG The Prestige GLYCERIN CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. GLYCERIN 10 g/50g 60951-185_bc2ff4b0-3ea4-4fee-a29c-2a6ee51b1c9d 60951-185 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101112 ANDA ANDA090428 Endo Pharmaceuticals Inc. DBA Endo Generic Products LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60951-186_bc2ff4b0-3ea4-4fee-a29c-2a6ee51b1c9d 60951-186 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101112 ANDA ANDA090428 Endo Pharmaceuticals Inc. DBA Endo Generic Products LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60951-187_bc2ff4b0-3ea4-4fee-a29c-2a6ee51b1c9d 60951-187 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101112 ANDA ANDA090428 Endo Pharmaceuticals Inc. DBA Endo Generic Products LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 60951-310_00151b40-9e02-11de-b2a5-0002a5d5c51b 60951-310 HUMAN PRESCRIPTION DRUG ENDODAN Oxycodone and Aspirin Tablets TABLET ORAL 19940520 NDA AUTHORIZED GENERIC NDA007337 Endo Pharmaceuticals Inc ASPIRIN; OXYCODONE HYDROCHLORIDE 325; 4.8355 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 60951-602_6165ebed-442b-45c0-81ef-ed58b979a167 60951-602 HUMAN PRESCRIPTION DRUG ENDOCET Oxycodone and Acetaminophen TABLET ORAL 20000526 ANDA ANDA040330 Qualitest Pharmaceuticals ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60951-652_a4bd0bd6-e846-48ed-9145-4c297ea48d59 60951-652 HUMAN PRESCRIPTION DRUG morphine sulfate morphine sulfate TABLET, EXTENDED RELEASE ORAL 19981031 ANDA ANDA075295 Qualitest Pharmaceuticals MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60951-653_a4bd0bd6-e846-48ed-9145-4c297ea48d59 60951-653 HUMAN PRESCRIPTION DRUG morphine sulfate morphine sulfate TABLET, EXTENDED RELEASE ORAL 19981031 ANDA ANDA075295 Qualitest Pharmaceuticals MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60951-655_a4bd0bd6-e846-48ed-9145-4c297ea48d59 60951-655 HUMAN PRESCRIPTION DRUG morphine sulfate morphine sulfate TABLET, EXTENDED RELEASE ORAL 19981031 ANDA ANDA075295 Qualitest Pharmaceuticals MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60951-658_a4bd0bd6-e846-48ed-9145-4c297ea48d59 60951-658 HUMAN PRESCRIPTION DRUG morphine sulfate morphine sulfate TABLET, EXTENDED RELEASE ORAL 19981031 ANDA ANDA075295 Qualitest Pharmaceuticals MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60951-659_a4bd0bd6-e846-48ed-9145-4c297ea48d59 60951-659 HUMAN PRESCRIPTION DRUG morphine sulfate morphine sulfate TABLET, EXTENDED RELEASE ORAL 19981031 ANDA ANDA075295 Qualitest Pharmaceuticals MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60951-700_6165ebed-442b-45c0-81ef-ed58b979a167 60951-700 HUMAN PRESCRIPTION DRUG ENDOCET Oxycodone and Acetaminophen TABLET ORAL 20030306 ANDA ANDA040434 Qualitest Pharmaceuticals ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60951-701_6165ebed-442b-45c0-81ef-ed58b979a167 60951-701 HUMAN PRESCRIPTION DRUG ENDOCET Oxycodone and Acetaminophen TABLET ORAL 20030306 ANDA ANDA040330 Qualitest Pharmaceuticals ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 2.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60951-712_6165ebed-442b-45c0-81ef-ed58b979a167 60951-712 HUMAN PRESCRIPTION DRUG ENDOCET Oxycodone and Acetaminophen TABLET ORAL 20030306 ANDA ANDA040434 Qualitest Pharmaceuticals ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60951-734_fb7e746f-3469-4e49-ad42-e0ed7d447d51 60951-734 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20100316 ANDA ANDA090111 Qualitest Pharmaceuticals MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 60951-735_726ff8af-e980-4c58-88cb-de9d6c699f1d 60951-735 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil mycophenolate mofetil TABLET ORAL 20100719 ANDA ANDA090606 Qualitest Pharmaceuticals MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 60951-794_adf101db-2e51-4ada-939c-13c9cf7eb16d 60951-794 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20100929 NDA AUTHORIZED GENERIC NDA021611 Qualitest Pharmaceuticals OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60951-795_adf101db-2e51-4ada-939c-13c9cf7eb16d 60951-795 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20100929 NDA AUTHORIZED GENERIC NDA021611 Qualitest Pharmaceuticals OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60951-933_6f91dad0-9eff-4559-9e51-85ee1fd5e047 60951-933 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride Tablets TABLET ORAL 20101009 ANDA ANDA078894 Endo Pharmaceuticals Inc. DBA Endo Generic Products PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 60951-934_6f91dad0-9eff-4559-9e51-85ee1fd5e047 60951-934 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride Tablets TABLET ORAL 20101009 ANDA ANDA078894 Endo Pharmaceuticals Inc. DBA Endo Generic Products PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 60951-935_6f91dad0-9eff-4559-9e51-85ee1fd5e047 60951-935 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride Tablets TABLET ORAL 20101009 ANDA ANDA078894 Endo Pharmaceuticals Inc. DBA Endo Generic Products PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 60951-936_6f91dad0-9eff-4559-9e51-85ee1fd5e047 60951-936 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride Tablets TABLET ORAL 20101009 ANDA ANDA078894 Endo Pharmaceuticals Inc. DBA Endo Generic Products PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 60951-937_6f91dad0-9eff-4559-9e51-85ee1fd5e047 60951-937 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride Tablets TABLET ORAL 20101009 ANDA ANDA078894 Endo Pharmaceuticals Inc. DBA Endo Generic Products PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 60971-1176_8b714f60-a1bc-4a9b-b2f6-37d705734894 60971-1176 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19931221 UNAPPROVED MEDICAL GAS Lehigh Valley Respiratory Care, Lancaster OXYGEN 99 L/100L 60977-001_7f845a30-d055-452d-957f-a8be87f52815 60977-001 HUMAN PRESCRIPTION DRUG Phenergan PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091210 ANDA ANDA083312 Baxter Healthcare Corporation PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 60977-002_7f845a30-d055-452d-957f-a8be87f52815 60977-002 HUMAN PRESCRIPTION DRUG Phenergan PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR 20091210 ANDA ANDA083312 Baxter Healthcare Corporation PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 60977-016_d36c9717-e9a4-4691-a75a-731f66e609ed 60977-016 HUMAN PRESCRIPTION DRUG Duramorph morphine sulfate INJECTION, SOLUTION EPIDURAL; INTRATHECAL; INTRAVENOUS 20100531 NDA NDA018565 Baxter Healthcare Corporation MORPHINE SULFATE .5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60977-017_d36c9717-e9a4-4691-a75a-731f66e609ed 60977-017 HUMAN PRESCRIPTION DRUG Duramorph morphine sulfate INJECTION, SOLUTION EPIDURAL; INTRATHECAL; INTRAVENOUS 20100531 NDA NDA018565 Baxter Healthcare Corporation MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 60977-112_fa86d00f-6a42-4f46-be91-80da90c67b99 60977-112 HUMAN PRESCRIPTION DRUG Ativan lorazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090924 NDA NDA018140 Baxter Healthcare Corporation LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60977-113_fa86d00f-6a42-4f46-be91-80da90c67b99 60977-113 HUMAN PRESCRIPTION DRUG Ativan lorazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090924 NDA NDA018140 Baxter Healthcare Corporation LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60977-116_fa86d00f-6a42-4f46-be91-80da90c67b99 60977-116 HUMAN PRESCRIPTION DRUG Ativan lorazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090924 NDA NDA018140 Baxter Healthcare Corporation LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 60977-141_e0fe9a3c-fa5a-488a-850b-6927899bc27b 60977-141 HUMAN PRESCRIPTION DRUG Protopam Chloride pralidoxime chloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19650310 NDA NDA014134 Baxter Healthcare Corporation PRALIDOXIME CHLORIDE 1 g/20mL Cholinesterase Reactivator [EPC],Cholinesterase Reactivators [MoA] 60977-144_a6bebe92-c96b-4022-a78b-652f03f32ca5 60977-144 HUMAN PRESCRIPTION DRUG Dopram DOXAPRAM HYDROCHLORIDE INJECTION INTRAVENOUS 20101129 NDA NDA014879 Baxter Healthcare Corporation DOXAPRAM HYDROCHLORIDE 20 mg/mL Increased Medullary Respiratory Drive [PE],Respiratory Stimulant [EPC] 60977-319_07eb92e1-3c44-4567-bbec-a24ed0b39c8a 60977-319 HUMAN PRESCRIPTION DRUG HYLENEX Recombinant Hyaluronidase Recombinant Human INJECTION, SOLUTION SUBCUTANEOUS 20051202 NDA NDA021859 Baxter Healthcare Corporation HYALURONIDASE RECOMBINANT HUMAN 150 [USP'U]/mL Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient] 60977-451_e1117cd7-d9b5-4bd0-bfc2-902518753463 60977-451 HUMAN PRESCRIPTION DRUG Reglan METOCLOPRAMIDE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101209 NDA NDA017862 Baxter Healthcare Corporation METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 60986-1003_1391be71-c5d5-474f-bd45-76a575558de9 60986-1003 HUMAN OTC DRUG Allernest Formicum acidum, Lachesis mutus, luffa Operculata. Petroleum, Rhus Toxicodebdron, Aralai racemosa,Galphimia glauca, thuja occidentalis, Urtica dicica and Cardiospermum LIQUID ORAL 20111118 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. ARALIA RACEMOSA ROOT; CARDIOSPERMUM HALICACABUM FLOWERING TOP; FORMIC ACID; GALPHIMIA GLAUCA FLOWERING TOP; KEROSENE; LACHESIS MUTA VENOM; LUFFA OPERCULATA FRUIT; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; URTICA DIOICA 4; 3; 12; 4; 6; 8; 6; 4; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 60986-1004_c92dc0a9-c2a0-49ca-aff3-c0b381412ced 60986-1004 HUMAN OTC DRUG Lymphonest Echinacea augustifolia, Scrophularia nodosa, Abrotanum, Petroleum, Aloe socotrina, Mercurius solubilis, Crotalus horiidus, Thuja occidentalis, Lachesis mutus, Aristolochia clematitis LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. ALOE; ARISTOLOCHIA CLEMATITIS ROOT; ARTEMISIA ABROTANUM FLOWERING TOP; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; KEROSENE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; SCROPHULARIA NODOSA; THUJA OCCIDENTALIS LEAFY TWIG 1; 6; 3; 10; 1; 3; 8; 12; 1; 10 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 60986-1008_9892a6c9-1ecf-475a-8bf4-11a13532d3c4 60986-1008 HUMAN OTC DRUG Cholenest Rhamnus purshiana, Carduus marianus, Taraxacum officinale, Chelidonium majus, Leptandra virginica, Myrica cerifera, Berberis vulgaris, Natrum sulphuricum, Magnesia phosphorica, Cuprum metallicum LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; COPPER; FRANGULA PURSHIANA BARK; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MORELLA CERIFERA ROOT BARK; SILYBUM MARIANUM SEED; SODIUM SULFATE; TARAXACUM OFFICINALE; VERONICASTRUM VIRGINICUM ROOT 2; 1; 8; 1; 8; 2; 1; 6; 1; 2 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 60986-1009_10a9a30e-71d4-4957-b285-122ca9ffadaf 60986-1009 HUMAN OTC DRUG Sabal Serrulatum Sabal serulatum, Lycopodium clavatum, Pareira brava LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. CHONDRODENDRON TOMENTOSUM ROOT; LYCOPODIUM CLAVATUM SPORE; SAW PALMETTO 4; 4; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 60986-1011_8bb74f2e-11d3-4428-89c2-be3df15bbbf5 60986-1011 HUMAN OTC DRUG Rubus Rubus Fruticosus, Iris Germanica, Vaccinium Myrtillus, Syzygium Jambolanum, Okoubaka Aubrevillei LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. BILBERRY; BLACKBERRY; IRIS GERMANICA ROOT; OKOUBAKA AUBREVILLEI BARK; SYZYGIUM CUMINI SEED 3; 2; 4; 6; 3 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 60986-1013_4c6f3fc8-9723-42a3-8fc2-9ea160f5a50d 60986-1013 HUMAN OTC DRUG Hydrastis Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis, SPRAY NASAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. DAPHNE MEZEREUM BARK; EPHEDRA DISTACHYA FLOWERING TWIG; GOLDENSEAL; KEROSENE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 4; 8; 3; 3; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 60986-1014_b991bcb6-1827-4f13-a954-2063d3bb3333 60986-1014 HUMAN OTC DRUG Contessa Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Ambra Grisea, Cimi LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. ALCHEMILLA XANTHOCHLORA FLOWERING TOP; AMBERGRIS; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; CINCHONA OFFICINALIS BARK; CONVALLARIA MAJALIS; CYCLAMEN PURPURASCENS TUBER; DELPHINIUM STAPHISAGRIA SEED; GALIUM ODORATUM; GOLDENSEAL; LILIUM LANCIFOLIUM FLOWERING TOP; MATRICARIA RECUTITA; MENTHA PIPERITA; NAJA NAJA VENOM; PACKERA AUREA; ROSMARINUS OFFICINALIS FLOWERING TOP; SAFFRON; TURNERA DIFFUSA LEAFY TWIG; VALERIAN; VIOLA ODORATA 1; 3; 3; 4; 2; 3; 2; 3; 3; 4; 1; 3; 4; 1; 1; 8; 4; 1; 3; 3; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 60986-1016_1a3c2fa2-b354-40f2-b01e-d47c285717c9 60986-1016 HUMAN OTC DRUG Trillium Calendula Officinalis, Chamomilla, Crocus Sativus, Equisetum Arvense, Hamamelis Virginiana, Lamium Album, Millefolium, Plantago Major, Quercus Robur, Thlaspi Bursa-Pastoris, Trillium Pendulum, Urtica LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. ACHILLEA MILLEFOLIUM; CALENDULA OFFICINALIS FLOWERING TOP; CAPSELLA BURSA-PASTORIS; EQUISETUM ARVENSE TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LAMIUM ALBUM; MATRICARIA RECUTITA; PLANTAGO MAJOR; QUERCUS ROBUR FLOWER; SAFFRON; TRILLIUM ERECTUM WHOLE; URTICA DIOICA; VISCUM ALBUM WHOLE 1; 1; 1; 1; 1; 1; 1; 1; 1; 3; 2; 1; 3 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 60986-1019_4244a7ce-fd9b-4466-ac3f-8ac81f650a0f 60986-1019 HUMAN OTC DRUG Lithium Lithium Bromatum LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. LITHIUM BROMIDE 3 [hp_X]/mL 60986-1020_dc3049d1-482b-4804-ab6e-0cbfa37957f3 60986-1020 HUMAN OTC DRUG Solidago Solidago Virgaurea, Uva-Ursi, Pareira Brava, Sabal Serrulata, Populus Tremuloides, Staphysagria, Cantharis, Terebinthia, Borax LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. ARCTOSTAPHYLOS UVA-URSI LEAF; CHONDRODENDRON TOMENTOSUM ROOT; DELPHINIUM STAPHISAGRIA SEED; LARIX DECIDUA RESIN; LYTTA VESICATORIA; POPULUS TREMULOIDES BARK; SAW PALMETTO; SODIUM BORATE; SOLIDAGO VIRGAUREA FLOWERING TOP 1; 3; 3; 6; 4; 2; 1; 8; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 60986-1021_d9f66e0a-0f79-43af-b59e-b2984e9a8850 60986-1021 HUMAN PRESCRIPTION DRUG CACTUS CACTUS GRANDIFLORUS, CONVALLARIA MAJALIS, CRATAEGUS LAEVIGATA, CAMPHORA, KALMIA LATIFOLIA, SPIGELIA ANTHELMIA, LACHESIS MUTUS, ARNICA MONTANA,TABACUM, GLONOINUM LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. ARNICA MONTANA; CAMPHOR (NATURAL); CONVALLARIA MAJALIS; CRATAEGUS LAEVIGATA WHOLE; KALMIA LATIFOLIA LEAF; LACHESIS MUTA VENOM; NITROGLYCERIN; SELENICEREUS GRANDIFLORUS STEM; SPIGELIA ANTHELMIA; TOBACCO LEAF 6; 2; 3; 1; 4; 8; 8; 2; 4; 8 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 60986-1022_c953c7dc-64cb-4a0a-9083-2c6c128e120b 60986-1022 HUMAN OTC DRUG Polygonum Polygonum Aviculare, Acorus Calamus, Rhus Toxicodendron, Gnaphalium Polycephalum, Rhododendron Chrysanthum, Colocynthis, Colchicum Autumnale, Kali Iodatum, Ichthyolum, Symphytum Officinale LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. ACORUS CALAMUS WHOLE; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; ICHTHAMMOL; POLYGONUM AVICULARE TOP; POTASSIUM IODIDE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 1; 3; 3; 1; 3; 1; 4; 2; 3; 4 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 60986-1024_260ad90d-3415-405a-a936-28450c1c7f9a 60986-1024 HUMAN OTC DRUG Female Tonic Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Ambra Grisea, Cimi LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. ALCHEMILLA XANTHOCHLORA FLOWERING TOP; AMBERGRIS; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; CINCHONA OFFICINALIS BARK; CONVALLARIA MAJALIS; CYCLAMEN PURPURASCENS TUBER; DELPHINIUM STAPHISAGRIA SEED; GALIUM ODORATUM; GOLDENSEAL; LILIUM LANCIFOLIUM FLOWERING TOP; MATRICARIA RECUTITA; MENTHA PIPERITA; NAJA NAJA VENOM; PACKERA AUREA; ROSMARINUS OFFICINALIS FLOWERING TOP; SAFFRON; TURNERA DIFFUSA LEAFY TWIG; VALERIAN; VIOLA ODORATA 1; 3; 3; 4; 2; 3; 2; 3; 3; 4; 1; 3; 4; 1; 1; 8; 4; 1; 3; 3; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL 60986-1027_3129c2dd-5d54-48ce-8c84-7e779ba96a6d 60986-1027 HUMAN OTC DRUG Aesculus Potentilla Anserina, Aesculus Hippocastanum, Ustilago Maidis, Secale Cornutum, Ruta Graveolens LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. ARGENTINA ANSERINA FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM; HORSE CHESTNUT; RUTA GRAVEOLENS WHOLE; USTILAGO MAYDIS 1; 4; 1; 3; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 60986-2000_1084b58e-310d-46c1-8a6c-0680132ba6e4 60986-2000 HUMAN OTC DRUG ECHINACEA ECHINACEA ANGUSTIFOLIA, HAMAMMELIS VIRGINIANA, CALCAREA PHOSPHORICA, HYDRASTIS CANADANESIS, SENEGA OFFICINALIS, SILICEA, CONIUM, AURUM MURIATICUM NATRONATUM, CALCAREA CARBONICA, FUCUS VESICULOSUS, LAC TABLET, ORALLY DISINTEGRATING ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; FUCUS VESICULOSUS; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POLYGALA SENEGA ROOT; SILICON DIOXIDE; SODIUM TETRACHLOROAURATE; TRIBASIC CALCIUM PHOSPHATE 4; 1; 5; 4; 2; 8; 5; 4; 4; 5; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 60986-2025_10564b75-239a-4415-a461-14c928a621f6 60986-2025 HUMAN OTC DRUG Luffa Luffa, Hydrastis Canadensis, Mercurius Sulph. Rub, Allium Cepa, Natrum Muriticum, Phosphorus, Eupatorium Perf, Sticta TABLET, ORALLY DISINTEGRATING ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. EUPATORIUM PERFOLIATUM FLOWERING TOP; GOLDENSEAL; LOBARIA PULMONARIA; LUFFA ACUTANGULA FRUIT; MERCURIC SULFIDE; ONION; PHOSPHORUS; SODIUM CHLORIDE 5; 4; 2; 6; 4; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 61010-1111_688a8109-a56b-4366-8af4-759b440aa0e9 61010-1111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20101216 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 540.26 g/L 61010-1111_982a523e-247d-4bc5-87ff-1bd89df2dac3 61010-1111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20101216 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 540.26 g/L 61010-1112_8cfb1b18-4e00-4265-87f5-a0971372d1e0 61010-1112 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20101216 OTC MONOGRAPH NOT FINAL part333E Safetec of America ALCOHOL 665 mL/L 61010-1112_b5d69c84-385d-4b48-a8bc-f00352cb4a2e 61010-1112 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20120322 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 665 mL/L 61010-1112_f061e83d-b73c-42d4-a7f4-849d47394b31 61010-1112 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20101215 OTC MONOGRAPH NOT FINAL part333E Safetec of America ALCOHOL 665 mL/L 61010-1122_c14cc5dc-4d3c-49f6-8a40-74f946d8deb6 61010-1122 HUMAN OTC DRUG Saniwash Antimicrobial Chloroxylenol LIQUID TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Safetec of America, Inc. CHLOROXYLENOL .006 mg/mL 61010-1250_02e4e200-08ec-4fa3-9078-c6855f945389 61010-1250 HUMAN OTC DRUG Ice menthol GEL TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part348 Safetec of America, Inc MENTHOL 34.79 mg/mL 61010-2111_0f38e341-1a4b-41c4-99b9-e1df2f8077e8 61010-2111 HUMAN OTC DRUG A.B.H.C. Instant Hand Sanitizer Citrus Scent alcohol GEL TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 665 mL/L 61010-2111_1a990ed0-e492-4a26-b747-cf832d485314 61010-2111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 540.26 g/L 61010-2111_de0ffa20-d280-4625-9c27-bb8ceeaff477 61010-2111 HUMAN OTC DRUG A.B.H.C. Instant Hand Sanitizer Citrus Scent alcohol GEL TOPICAL 20100501 OTC MONOGRAPH FINAL part333 Safetec of America, Inc. ALCOHOL 665 mL/L 61010-3111_da433793-4e8f-403d-a59c-59ef68abb533 61010-3111 HUMAN OTC DRUG Antimicrobial alcohol LIQUID TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 665 mL/L 61010-3112_cd32e18d-c5fc-43b7-8536-9514536aea89 61010-3112 HUMAN OTC DRUG Antibacterial alcohol LIQUID TOPICAL 20110502 OTC MONOGRAPH NOT FINAL part333E Safetec of America ALCOHOL 665 mL/L 61010-3200_86bb8108-bb10-42f4-a848-96d7d3d8f17d 61010-3200 HUMAN OTC DRUG Antimicrobial alcohol LIQUID TOPICAL 20110307 OTC MONOGRAPH NOT FINAL part333E Safetec of America ALCOHOL 665 mL/L 61010-3300_ad081a6d-f23b-4889-955a-067f6b424b53 61010-3300 HUMAN OTC DRUG Antimicrobial alcohol LIQUID TOPICAL 20131213 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 665 mg/L 61010-4111_4c651bef-b3e8-47a0-8801-ddeebbbf3b1f 61010-4111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20101216 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL .7 g/mL 61010-4111_61b46712-2151-4e32-8f25-141c3cbddc04 61010-4111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part333E Safetec of America ALCOHOL .7 g/mL 61010-5000_570002db-ee92-42aa-b1f0-4c9942ef09e5 61010-5000 HUMAN OTC DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride GEL TOPICAL 20120919 OTC MONOGRAPH NOT FINAL part348 Safetec of America, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/g 61010-5100_2df5b2b2-343a-4c5e-ac31-fa4fa7206085 61010-5100 HUMAN OTC DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride LIQUID TOPICAL 20110802 OTC MONOGRAPH NOT FINAL part348 Safetec of America, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL 61010-5111_71896ce2-78d7-4bb0-a793-ef213cdb0f68 61010-5111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 665 mg/L 61010-5200_8792eaa2-5fd8-41fa-8cfc-b00614c115fe 61010-5200 HUMAN OTC DRUG Antiseptic alcohol, lidocaine hydrochloride LIQUID TOPICAL 20110930 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL; LIDOCAINE HYDROCHLORIDE 500; 20 mg/g; mg/g 61010-5300_ca6e7215-80cc-408a-a7ad-2748f3fc6b3a 61010-5300 HUMAN OTC DRUG Antiseptic benzalkonium chloride, benzocaine SPRAY TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333A Safetec of America, Inc. BENZALKONIUM CHLORIDE; BENZOCAINE 1; 50 mg/g; mg/g 61010-5400_816fe0cd-1bfa-4b9d-ae77-aad1af19887e 61010-5400 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SPRAY TOPICAL 20120216 OTC MONOGRAPH NOT FINAL part333A Safetec of America, Inc. HYDROGEN PEROXIDE 30 mL/L 61010-5500_64c27eab-58fa-40fe-abc5-72d0f436b46f 61010-5500 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SPRAY TOPICAL 20120216 OTC MONOGRAPH NOT FINAL part333A Safetec of America, Inc. ISOPROPYL ALCOHOL 700 mL/L 61010-5600_b9969bb4-4a06-41ca-96b3-52542eb19c67 61010-5600 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20110808 OTC MONOGRAPH FINAL part333B Safetec of America, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 61010-5603_f7a6a707-f75d-4571-9721-031518f2bea4 61010-5603 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20070330 OTC MONOGRAPH FINAL part333B Safetec of America, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 61010-5701_1559b311-c0e3-4364-807c-e07d8c0a2cbb 61010-5701 HUMAN OTC DRUG First Aid and Burn Benzalkonium Chloride, Lidocaine Hydrochloride CREAM TOPICAL 20120921 OTC MONOGRAPH NOT FINAL part333A Safetec of America, Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g 61010-5800_6164b28b-c156-47d3-9652-7f7e453ef917 61010-5800 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20101215 OTC MONOGRAPH NOT FINAL part348 Safetec of America, Inc. HYDROCORTISONE 10 mg/g 61010-6103_0d7f63ee-36e2-4e1b-bb68-7f3e2461aab6 61010-6103 HUMAN OTC DRUG Sunscreen Homosalate, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20070313 OTC MONOGRAPH NOT FINAL part352 Safetec of America, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 6; 7.5; 5; 5 mg/g; mg/g; mg/g; mg/g 61010-6111_d3c94548-eea9-4291-9ca4-f29bfd860e16 61010-6111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20131111 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 700 mg/L 61010-7000_188fff36-2829-4077-8115-bb90e0c25bbb 61010-7000 HUMAN OTC DRUG Antiseptic isopropyl alcohol LIQUID TOPICAL 20110502 OTC MONOGRAPH NOT FINAL part333A Safetec of America ISOPROPYL ALCOHOL 715 mL/L 61010-7100_8acf1da5-9b48-4f06-a454-f0d7700da6cd 61010-7100 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20110505 OTC MONOGRAPH NOT FINAL part333E Safetec of America BENZALKONIUM CHLORIDE 1.3 mL/L 61010-7110_3d303415-56fe-4445-82ed-bb2b40651430 61010-7110 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20110712 OTC MONOGRAPH NOT FINAL part333E Safetec of America BENZALKONIUM CHLORIDE 1.3 mL/L 61010-7111_8ff67b75-9bdb-4fb2-9876-e3ec7cdb9f72 61010-7111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20131106 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 700 mg/L 61010-7200_de1cfe9e-2cd4-4ed5-b499-1184e66fc558 61010-7200 HUMAN OTC DRUG Antiseptic alcohol, benzocaine LIQUID TOPICAL 20110512 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL; BENZOCAINE 500; 60 mg/g; mg/g 61010-8100_ec1e9e72-8cd4-459d-a7c0-dcffa3dfa6e9 61010-8100 HUMAN OTC DRUG Pain Relief benzocaine LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part356 Safetec of America, Inc. BENZOCAINE 200 mg/g 61010-8200_5be909cf-57fe-4831-a6bb-7bfd82c732e6 61010-8200 HUMAN OTC DRUG Analgesic menthol SPRAY TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part348 Safetec of America, Inc. MENTHOL 700 mL/L 61010-8300_008112db-7e33-4763-9784-9a958bcb71e6 61010-8300 HUMAN OTC DRUG Itch Relief diphenhydramine hydrochloride LIQUID TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part348 Safetec of America, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 20.3 g/L 61010-8400_dc98202d-8a86-4b94-bdf1-e6a70e0bacac 61010-8400 HUMAN OTC DRUG Hand Sanitizer benzalkonium chloride LIQUID TOPICAL 20140114 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. BENZALKONIUM CHLORIDE 1 mg/L 61010-8600_ede480a3-b01c-4d9c-bf80-ede08b298b67 61010-8600 HUMAN OTC DRUG Saniwash Antimicrobial Foaming Hand Chloroxylenol LIQUID TOPICAL 20140313 OTC MONOGRAPH NOT FINAL part333A Safetec of America, Inc. CHLOROXYLENOL .006 g/mL 61010-8700_315ad1cc-5f75-4bc2-ba0a-59633173e11f 61010-8700 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 665 mg/L 61016-0001_5a8dc127-a9c9-4aca-a3da-e53f5fbea2c9 61016-0001 HUMAN OTC DRUG Anti-Aging Tinted Moisturizer Broad Spectrum SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20120223 OTC MONOGRAPH FINAL part352 Columbia Cosmetics Manufacturing, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL 61016-0002_bc2e7941-806c-40e0-8734-2569f6fdbe80 61016-0002 HUMAN OTC DRUG Antioxidant Day SPF 15 OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20120419 OTC MONOGRAPH FINAL part352 Columbia Cosmetics Manufacturing, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 3; 3 mL/100mL; mL/100mL; mL/100mL 61016-0003_e26b4334-5aa8-435d-913b-bf7774cadfa9 61016-0003 HUMAN OTC DRUG Anti-Aging Daily Moisturizer Sunscreen Broad-Spectrum SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20120419 OTC MONOGRAPH FINAL part352 Columbia Cosmetics Manufacturing, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL 61016-0004_baa007e7-9662-4bd3-95a3-cad8b8c2e649 61016-0004 HUMAN OTC DRUG the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum lighter than light OCTINOXATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20130729 OTC MONOGRAPH NOT FINAL part352 Columbia Cosmetics Manufacturing, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 30 mg/mL; mg/mL; mg/mL 61016-0005_3f94c2f3-0746-434d-beea-00ff07b3ae9d 61016-0005 HUMAN OTC DRUG the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum medium dark OCTINOXATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20130729 OTC MONOGRAPH NOT FINAL part352 Columbia Cosmetics Manufacturing, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 30 mg/mL; mg/mL; mg/mL 61016-0006_125a52e7-5748-4c2e-93d2-303c30cba204 61016-0006 HUMAN OTC DRUG the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum dark OCTINOXATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20130729 OTC MONOGRAPH NOT FINAL part352 Columbia Cosmetics Manufacturing, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 30 mg/mL; mg/mL; mg/mL 61016-0007_d934600b-51c9-4ff3-8a5a-c5a4ade85bc2 61016-0007 HUMAN OTC DRUG the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum after dark OCTINOXATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20130729 OTC MONOGRAPH NOT FINAL part352 Columbia Cosmetics Manufacturing, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 30 mg/mL; mg/mL; mg/mL 61037-412_064ea004-3f4c-1633-e054-00144ff88e88 61037-412 HUMAN OTC DRUG Scrub Chlorhexidine Gluconate SOLUTION TOPICAL 20140930 NDA NDA020111 Bajaj Medical, LLC CHLORHEXIDINE GLUCONATE .75 mg/100mL 61037-413_064ea004-3f5c-1633-e054-00144ff88e88 61037-413 HUMAN OTC DRUG Dyna-Hex 75 Antiseptic Handwash SOLUTION TOPICAL 20140930 NDA NDA020111 Bajaj Medical, LLC CHLORHEXIDINE GLUCONATE .75 mg/100mL 61041-211_07ceb03e-9994-498c-a020-d7f17f9da10b 61041-211 HUMAN OTC DRUG XEROSTOM SODIUM FLUORIDE MOUTHWASH ORAL 20131115 OTC MONOGRAPH FINAL part355 Bio Cosmetics SODIUM FLUORIDE .559 mg/mL 61041-212_6ac32867-7997-4ac9-b70a-5959c352bc53 61041-212 HUMAN OTC DRUG XEROSTOM SODIUM FLUORIDE PASTE ORAL 20131108 OTC MONOGRAPH FINAL part355 Bio Cosmetics S L SODIUM FLUORIDE 2.2 mg/g 61045-0001_753319dd-5c98-4d20-869a-47624b4be42d 61045-0001 HUMAN OTC DRUG ARTHRONEW AM NOT APPLICABLE GEL TOPICAL 20141103 UNAPPROVED HOMEOPATHIC PureCore Wellness, Inc. CAPSICUM; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 6; 12; 3; 6; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 61045-0002_8a5c6964-70ba-41ef-940f-bd40f4407e2b 61045-0002 HUMAN OTC DRUG ARTHRONEW PM NOT APPLICABLE GEL TOPICAL 20141103 UNAPPROVED HOMEOPATHIC PureCore Wellness, Inc ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g 61047-770_ca1d569d-ac58-4351-a9ca-b3a86613abe1 61047-770 HUMAN OTC DRUG Close Up Anticavity Toothpaste Anticavity Toothpaste GEL DENTAL 20100325 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products SODIUM FLUORIDE .27 g/113.4g 61047-771_dec0bb47-280a-4c76-9aeb-fb3164af043d 61047-771 HUMAN OTC DRUG Close Up Anticavity Toothpaste Anticavity Toothpaste GEL DENTAL 20100326 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products SODIUM FLUORIDE .54 g/226.8g 61047-810_42ebf49c-9b98-4b0a-bbe9-22d0c60b8a5b 61047-810 HUMAN OTC DRUG Banana Boat Sport Performance Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100312 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .58; 5.8; 2.9; .464; 2.32 mL/58mL; mL/58mL; mL/58mL; mL/58mL; mL/58mL 61047-811_98665009-5a5a-459d-8c42-47b44ffbe205 61047-811 HUMAN OTC DRUG Banana Boat Ultra Defense Broad Spectrum Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100323 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.36; 35.4; 11.8; 2.95; 14.16 mL/236mL; mL/236mL; mL/236mL; mL/236mL; mL/236mL 61047-812_1e980e64-1b5a-4227-8c2e-9afa94c596fb 61047-812 HUMAN OTC DRUG Banana Boat Ultra Defense Sheer Protect Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100319 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.36; 23.6; 11.8; 1.88; 9.44 mL/236mL; mL/236mL; mL/236mL; mL/236mL; mL/236mL 61047-813_3433e103-1c18-468e-96c9-ed32332a94b0 61047-813 HUMAN OTC DRUG Banana Boat Sport Performance Active Dry protect Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100319 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.95; 29.5; 14.75; 2.36; 11.8 mL/295mL; mL/295mL; mL/295mL; mL/295mL; mL/295mL 61047-814_fe2ca488-fe49-461d-af82-8bb89de56b24 61047-814 HUMAN OTC DRUG Banana Boat Sport Performance Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100322 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .88; 8.8; 4.4; .7; 3.52 mL/88mL; mL/88mL; mL/88mL; mL/88mL; mL/88mL 61047-815_98ef9f27-5f50-4a44-b1b4-ac2470a72ef5 61047-815 HUMAN OTC DRUG Banana Boat Sport Performance Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100322 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .88; 8.85; 2.95; .74; 3.54 mL/59mL; mL/59mL; mL/59mL; mL/59mL; mL/59mL 61047-816_75cc4822-8c8d-41f7-ace7-0988026da845 61047-816 HUMAN OTC DRUG Banana Boat Sport Performance Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100322 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.95; 29.5; 14.75; 2.36; 11.8 mL/295mL; mL/295mL; mL/295mL; mL/295mL; mL/295mL 61047-817_c80e1e77-def8-40e9-bbd3-dfc2cb9428df 61047-817 HUMAN OTC DRUG Banana Boat Sport Performance Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100323 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.36; 23.6; 11.8; 1.88; 9.44 mL/236mL; mL/236mL; mL/236mL; mL/236mL; mL/236mL 61047-818_beb678fe-ac79-4353-ac35-94035f12af94 61047-818 HUMAN OTC DRUG Banana Boat Sport Performance Avobenzone, Homosalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100323 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 2.36; 14.16; 1.88; 4.72 mL/236mL; mL/236mL; mL/236mL; mL/236mL 61047-819_2fd4c631-d6f4-4827-a296-750d6466b29e 61047-819 HUMAN OTC DRUG Banana Boat Ultra Defense Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100325 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.54; 35.4; 11.8; 2.95; 14.16 mL/236mL; mL/236mL; mL/236mL; mL/236mL; mL/236mL 61047-820_99e5b34c-12a1-4131-96c5-60647246ceef 61047-820 HUMAN OTC DRUG Banana Boat Sport Performance Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100325 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .59; 5.9; 2.95; .47; 2.36 mL/59mL; mL/59mL; mL/59mL; mL/59mL; mL/236mL 61047-824_5700f991-5c7c-4729-8e7b-c59606d57eb0 61047-824 HUMAN OTC DRUG Purpose Sunscreen Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20130408 OTC MONOGRAPH NOT FINAL part352 KIK Custom Products OCTINOXATE; OCTISALATE; OXYBENZONE 9; 6; 3.6 g/120g; g/120g; g/120g 61047-825_d9f4e247-b2a3-4757-b6fd-44e547ac2638 61047-825 HUMAN OTC DRUG AMBI Sunscreen Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130409 OTC MONOGRAPH NOT FINAL part352 KIK Custom Products AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.77; 2.95; 1; 1.77 g/59g; g/59g; g/59g; g/59g 61047-831_352d444d-a1d4-4a9f-9d60-c3f4eac4f165 61047-831 HUMAN OTC DRUG Banana Boat Sport Performance Active Dry Protect SPF UVB 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part352 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 5.31; 53.1; 17.7; 4.42; 17.7 mL/354mL; mL/354mL; mL/354mL; mL/354mL; mL/354mL 61062-0001_6ec81d7f-46dd-429a-a8b0-3bb27cfa59a0 61062-0001 HUMAN OTC DRUG D1 Organ Support not applicable LIQUID ORAL 20140806 UNAPPROVED HOMEOPATHIC Restivo Chiropractic .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; AVENA SATIVA FLOWERING TOP; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; FORMIC ACID; GLYOXAL TRIMER DIHYDRATE; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; MALIC ACID; MENADIONE; METHYLCOBALAMIN; MILK THISTLE; OROTIC ACID MONOHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK INTESTINE; PORK LIVER; PROTEUS MORGANII; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA GALLBLADDER; SUS SCROFA LYMPH; SUS SCROFA PANCREAS; SUS SCROFA THYMUS; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOT 10; 8; 6; 4; 10; 4; 6; 10; 10; 10; 4; 10; 6; 6; 3; 7; 28; 8; 8; 30; 30; 10; 13; 8; 8; 8; 8; 8; 8; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 61062-0003_148513a8-3d0e-4633-8a39-c713ded1151a 61062-0003 HUMAN OTC DRUG D3 Organ Support Not applicable LIQUID ORAL 20140806 UNAPPROVED HOMEOPATHIC Restivo Chiropractic ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; BARIUM CARBONATE; BISPHENOL A; BROMINE; CHLORINE; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; ECHINACEA ANGUSTIFOLIA; ESCHERICHIA COLI; FERROSOFERRIC PHOSPHATE; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; HORSE CHESTNUT; HYDROFLUORIC ACID; IODINE; LACTIC ACID, L-; LIOTHYRONINE; MERCURIUS SOLUBILIS; PHENYLALANINE; PORK LIVER; PROTORTONIA CACTI; PULSATILLA VULGARIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA TONSIL; SUS SCROFA UMBILICAL CORD; TRIBASIC CALCIUM PHOSPHATE 6; 6; 28; 12; 12; 12; 4; 13; 4; 30; 10; 6; 6; 6; 6; 12; 12; 6; 10; 13; 8; 10; 6; 6; 9; 4; 8; 8; 12; 10; 8; 10; 6; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 61062-0004_4cbc8e3c-6292-42e9-b99a-b61e65f3fb88 61062-0004 HUMAN OTC DRUG Brain Support not applicable LIQUID ORAL 20140811 UNAPPROVED HOMEOPATHIC Restivo Chiropractic .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; ADENOSINE CYCLIC PHOSPHATE; DOPAMINE HYDROCHLORIDE; EPINEPHRINE; NOREPINEPHRINE; OCTOPAMINE; SEROTONIN HYDROCHLORIDE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; TAURINE 6; 6; 8; 6; 6; 6; 6; 6; 8; 8; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 61062-0005_c489397a-6247-420b-94ba-5083a06b2666 61062-0005 HUMAN OTC DRUG Chemdetox not applicable LIQUID ORAL 20140811 UNAPPROVED HOMEOPATHIC Restivo Chiropractic ACETIC ACID; ARCTIUM LAPPA ROOT; ATROPA BELLADONNA; BENZOIC ACID; BENZYL ALCOHOL; BERBERIS VULGARIS ROOT BARK; BORIC ACID; CHLORINE; CORTICOTROPIN; CORTISONE ACETATE; ESTRONE; EUGENOL; GLYCYRRHIZA GLABRA; IRIDIUM; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LEAD; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PETROLATUM; PHENYL BUTYRATE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PORK LIVER; POTASSIUM SORBATE; RESORCINOL; SALICYLIC ACID; SELENIUM; SORBITOL; STEARYL ALCOHOL; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA THYROID; TRIFOLIUM PRATENSE FLOWER; XYLITOL 30; 3; 12; 30; 30; 3; 30; 30; 30; 30; 30; 30; 3; 12; 30; 30; 30; 12; 12; 30; 30; 12; 3; 8; 30; 30; 30; 12; 30; 30; 3; 12; 8; 8; 8; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 61062-0006_2f2f60dc-800d-4ce7-9c38-675e119291bf 61062-0006 HUMAN OTC DRUG Insecticides and Pest and Food Additives Detox not applicable LIQUID ORAL 20140805 UNAPPROVED HOMEOPATHIC Restivo Chiropractic ARSENIC TRIOXIDE; ASPARTAME; ATROPA BELLADONNA; BENZALKONIUM CHLORIDE; BETA VULGARIS; CHELIDONIUM MAJUS; COBALT; COPPER; FORMALDEHYDE; IODINE; LYCOPODIUM CLAVATUM SPORE; METHYLENE CHLORIDE; METHYLPARABEN; PETROSELINUM CRISPUM; PEUMUS BOLDUS LEAF; PHOSPHORIC ACID; PROPYLPARABEN; SELENIUM; SODIUM BENZOATE; SODIUM CITRATE; TARAXACUM OFFICINALE; TITANIUM DIOXIDE; ZINC; ZINC OXIDE 12; 30; 12; 30; 3; 3; 12; 12; 30; 12; 12; 30; 30; 3; 3; 12; 30; 12; 30; 30; 3; 30; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 61062-0007_e1780e22-4107-4c58-8055-daa33fde1012 61062-0007 HUMAN PRESCRIPTION DRUG METDETOX Allium sativum, Berberis vulgaris, Glycyrrhiza glabra, Lappa Major, Phytolacca decandra, Stillingia sylvatica, Trifolium pratense, Ascorbic acid, LIQUID ORAL 20131210 UNAPPROVED HOMEOPATHIC Restivo Chiropractic ALUMINUM; ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; ASCORBIC ACID; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM; CHROMIUM; COBALT; COPPER; CYSTEINE; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; FORMALDEHYDE; GADOLINIUM OXIDE; GARLIC; GERMANIUM SESQUIOXIDE; GLYCYRRHIZA GLABRA; GOLD; HOLMIUM; IRIDIUM; IRON; LANTHANUM OXIDE; LEAD; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; METHIONINE; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PHENOL; PHYTOLACCA AMERICANA ROOT; PLATINUM; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; SILVER; SODIUM CHLORIDE; STILLINGIA SYLVATICA ROOT; STRONTIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; TANTALUM; TERBIUM; THALLIUM; THYROID, PORCINE; TIN; TRIFOLIUM PRATENSE FLOWER; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC 12; 12; 3; 12; 6; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 6; 12; 12; 112; 12; 12; 3; 12; 3; 12; 12; 8; 12; 12; 12; 12; 12; 12; 12; 12; 8; 12; 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 12; 8; 12; 12; 3; 12; 12; 12; 12; 12; 8; 12; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA],Mood Stabilizer [EPC],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 61062-0008_938a5c2b-ab34-494c-a7af-4e671c140c58 61062-0008 HUMAN OTC DRUG Intercellular Detox not applicable LIQUID ORAL 20140805 UNAPPROVED HOMEOPATHIC Restivo Chiropractic ATROPA BELLADONNA; CEANOTHUS AMERICANUS LEAF; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; MARSDENIA CONDURANGO BARK; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS MONTANA LEAF; PHOSPHORUS; PORK INTESTINE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SHIGELLA DYSENTERIAE; SILVER NITRATE; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; SUS SCROFA JEJUNUM; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; SUS SCROFA RECTUM; SUS SCROFA STOMACH; SUS SCROFA URINARY BLADDER; VERATRUM ALBUM ROOT; WOOD CREOSOTE; YEAST MANNAN 10; 4; 4; 8; 10; 10; 6; 6; 6; 8; 8; 8; 6; 6; 30; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 6; 4; 10; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 61062-0009_61110ef8-bf10-4e49-9fe1-f68e47c31509 61062-0009 HUMAN OTC DRUG NS Support not applicable LIQUID ORAL 20140805 UNAPPROVED HOMEOPATHIC Restivo Chiropractic .ALPHA.-LIPOIC ACID; AMMONIUM CHLORIDE; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COENZYME A; CUPRIC ACETATE; ENTEROBACTER CLOACAE; HORSE CHESTNUT; LEDUM PALUSTRE TWIG; MERCURIC OXIDE; NADIDE; NIACINAMIDE; PICRIC ACID; PROTEUS MORGANII; PROTEUS VULGARIS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; PYRIDOXINE HYDROCHLORIDE; RANUNCULUS BULBOSUS; RIBOFLAVIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SILICON DIOXIDE; SILVER; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SUS SCROFA UMBILICAL CORD; THIAMINE HYDROCHLORIDE; TRIBASIC CALCIUM PHOSPHATE 8; 8; 4; 4; 4; 4; 10; 6; 30; 6; 4; 10; 6; 6; 6; 30; 30; 10; 6; 4; 6; 30; 8; 10; 6; 28; 10; 10; 8; 8; 10; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 61065-1001_c1e67dcf-2516-421a-9c33-2e3960fd1521 61065-1001 HUMAN OTC DRUG SUPER MIRAPHARM PANAX GINSENG WHOLE CAPSULE ORAL 20131118 UNAPPROVED DRUG OTHER Mirapharm Inc PANAX GINSENG WHOLE .3 g/1 61077-001_62dcf4da-7e73-41e6-a624-3b2211447e5a 61077-001 HUMAN OTC DRUG H-Warts Formula Phytolacca decandra, Thuja occidentalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 12; 12 [hp_C]/11mL; [hp_C]/11mL 61077-003_5d17dfc9-8940-4d2e-829e-9293bb6e2f0c 61077-003 HUMAN OTC DRUG H-Hemorrhoids Formula Aesculus hippocastanum, Collinsonia canadensis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils AESCULUS HIPPOCASTANUM FLOWER; COLLINSONIA CANADENSIS ROOT 12; 12 [hp_C]/11mL; [hp_C]/11mL 61077-005_28a322de-e2d7-4960-8279-59bc46211d2a 61077-005 HUMAN OTC DRUG H-BI Hemorrhoids Formula calendula officinallis, hamamelis virginiana OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 12; 6 [hp_C]/11mL; [hp_C]/11mL 61077-011_fbdf4890-a189-4fbf-baef-e077677c2b79 61077-011 HUMAN OTC DRUG H-Shingles Formula calendula officinalis, iris versicolor, ranunculus bulbosus OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils CALENDULA OFFICINALIS FLOWERING TOP; IRIS VERSICOLOR ROOT; RANUNCULUS BULBOSUS 12; 12; 12 [hp_C]/11mL; [hp_C]/11mL; [hp_C]/11mL 61077-019_07ca15f9-6c73-4c8e-8552-085f76ad58c6 61077-019 HUMAN OTC DRUG H- Eczema Formula anacardium orientale, iris versicolor OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils IRIS VERSICOLOR ROOT; SEMECARPUS ANACARDIUM JUICE 12; 12 [hp_C]/11mL; [hp_C]/11mL 61077-020_b832d679-a4f6-4c12-984c-39bfeb6adaa2 61077-020 HUMAN OTC DRUG H-Acne Formula calendula officinalis, nux vomica, silicea OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED 12; 12; 12 [hp_C]/11mL; [hp_C]/11mL; [hp_C]/11mL 61077-021_e0170eeb-11e1-4e99-a17a-ec3722091263 61077-021 HUMAN OTC DRUG H-Athletes Foot Formula calendula officinalis, lycopodium clavatum, thuja occidentalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12 [hp_C]/11mL; [hp_C]/11mL; [hp_C]/11mL 61077-026_0305bb25-6fef-4309-b59f-017ba1e66ab7 61077-026 HUMAN OTC DRUG H-Molluscum Formula calendula officinalis, thuja occidentalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG 12; 12 [hp_C]/11mL; [hp_C]/11mL 61077-028_7d28f9d3-f884-496b-bec5-6c372b65ff9c 61077-028 HUMAN OTC DRUG H-Skin Tags Formula calendula officinalis, thuja occidentalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG 12; 12 [hp_C]/11mL; [hp_C]/11mL 61077-034_65c604ce-1c98-4c1c-b82e-65e9c22a4cb0 61077-034 HUMAN OTC DRUG H-Arthritis Formula apium graveolens, arnica montana OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC ARNICA MONTANA; CELERY SEED 12; 12 [hp_C]/11mL; [hp_C]/11mL 61077-036_ecddd2b9-95a2-48a2-ae10-47f7fedf58fc 61077-036 HUMAN OTC DRUG H-Fissures Formula calendula officinalis, chamomilla OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA 12; 6 [hp_C]/11mL; [hp_C]/11mL 61077-038_dbfb8377-7369-48fa-b5cf-4d933e244cbd 61077-038 HUMAN OTC DRUG H-Headaches Formula apium graveolens, nux vomica OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CELERY SEED; STRYCHNOS NUX-VOMICA SEED 12; 12 [hp_C]/11mL; [hp_C]/11mL 61077-039_79f82f76-561a-4793-9e7b-0b50c51aed81 61077-039 HUMAN OTC DRUG H-Scars Formula calendula officinallis, silicea OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE 12; 12 [hp_C]/11mL; [hp_C]/11mL 61077-047_1318c507-8b44-43f5-85f9-43c2af541ece 61077-047 HUMAN OTC DRUG H-Psoriasis Formula calendula officinalis, iris versicolor OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; IRIS VERSICOLOR ROOT 12; 12 [hp_C]/11mL; [hp_C]/11mL 61077-088_2d55d639-40cd-4c27-bb8d-a06923ee08bf 61077-088 HUMAN OTC DRUG H-Jock Itch Formula calendula officinalis, thuja occidentalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG 12; 12 [hp_C]/11mL; [hp_C]/11mL 61077-096_7f21fe7b-6f23-4110-8999-2f725c545f4f 61077-096 HUMAN OTC DRUG H-Varicose Veins Formula Aesculus hippocastanum, Collinsonia canadensis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC COLLINSONIA CANADENSIS ROOT; HORSE CHESTNUT 12; 12 [hp_C]/11mL; [hp_C]/11mL 61077-101_8c3e18bc-13fd-4750-8cf5-6debe1bbc7fb 61077-101 HUMAN OTC DRUG SP1 Formula phytolacca decandra, thuja occidentalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 15; 15 [hp_C]/11mL; [hp_C]/11mL 61077-117_c3a5819b-da72-49be-8d04-3bc63b5588c1 61077-117 HUMAN OTC DRUG H-Insomnia Formula apium graveolens, salvia officinalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CELERY SEED; SAGE 6; 6 [hp_C]/11mL; [hp_C]/11mL 61077-121_f0b05a5c-a495-4679-a317-6d8ff057acef 61077-121 HUMAN OTC DRUG H-Rosacea Formula belladonna, nux vomica OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC ATROPA BELLADONNA; STRYCHNOS NUX-VOMICA SEED 6; 12 [hp_C]/11mL; [hp_C]/11mL 61077-123_8bfffde2-098a-4973-bd8c-230c344d2b34 61077-123 HUMAN OTC DRUG H-Nail Fungus Formula calendula officinalis, silicea, thuja occidentalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12 [hp_C]/11mL; [hp_C]/11mL; [hp_C]/11mL 61077-125_04c76e79-c521-4e8d-a3d7-e9f544500832 61077-125 HUMAN OTC DRUG H-Moles Formula calendula officinalis, phytolacca decandra, thuja occidentalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12 [hp_C]/11mL; [hp_C]/11mL; [hp_C]/11mL 61077-127_9bc9ec72-88d7-4959-ab22-8b64863822dc 61077-127 HUMAN OTC DRUG H-Cold Sores Formula calendula officinalis, ranunculus bulbosus OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; RANUNCULUS BULBOSUS 12; 12 [hp_C]/11mL; [hp_C]/11mL 61084-125_07c4fd76-cadb-4f6e-a4d1-e9288229c492 61084-125 HUMAN OTC DRUG Emergency Zit Stick Acne Treatment Salicylic Acid STICK TOPICAL 20131105 OTC MONOGRAPH FINAL part358H Basic Research SALICYLIC ACID 2 g/2mL 61084-126_52f429fb-541b-4d2a-a110-fd9bc3e586c7 61084-126 HUMAN OTC DRUG Clinical Emergency Zit Stick Acne Treatment Salicylic Acid STICK TOPICAL 20131105 OTC MONOGRAPH FINAL part358H Basic Research SALICYLIC ACID 2 g/2mL 61095-100_d04e26e7-eb65-4f92-82c4-6d2481a874a3 61095-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19940101 UNAPPROVED MEDICAL GAS GT Industries Inc OXYGEN 990 mL/L 61095-200_516c4c6f-b079-4565-a8e4-2e97fb2aa351 61095-200 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19940101 UNAPPROVED MEDICAL GAS GT Industries Inc NITROGEN 990 mL/L 61095-300_20b3af9a-5d4c-4bcc-bfdc-691e2f475510 61095-300 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19940101 UNAPPROVED MEDICAL GAS GT Industries Inc HELIUM 990 mL/L 61096-0001_5c97b252-9414-487d-8e67-6aab3520f36d 61096-0001 HUMAN OTC DRUG Sprayology SleepEase Aquilegia vulgaris, Avena sativa, Chamomilla, Coffea cruda, Cypripedium pubescens, Humulus lupulus, Kali phosphoricum, Passiflora incarnata, Valeriana officinalis, Zincum metallicum LIQUID ORAL 20140102 UNAPPROVED HOMEOPATHIC Eight and Company AQUILEGIA VULGARIS; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; CYPRIPEDIUM PARVIFOLUM ROOT; HOPS; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; VALERIAN; ZINC 1; 200; 1; 3; 3; 1; 1; 12; 1; 12 [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL 61096-0002_52113e87-c793-4f3d-b166-5b3689f50dbd 61096-0002 HUMAN OTC DRUG Sprayology Cold and Flu Relief Allium cepa, Antimonium tartaricum, Arnica montana, Baptisia tinctoria, Eupatorium perfoliatum, Gelsemium sempervirens, Kali bichromicum, Lachesis mutus, Mercurius iodatus ruber, Sticta pulmonaria, Sulphur iodatum, Urtica urens LIQUID ORAL 20131106 UNAPPROVED HOMEOPATHIC Eight and Company ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; LOBARIA PULMONARIA; MERCURIC IODIDE; ONION; POTASSIUM DICHROMATE; SULFUR IODIDE; URTICA URENS 200; 3; 3; 200; 200; 200; 200; 200; 30; 200; 200; 200 [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL 61096-0003_221960b7-aff1-4d50-a7ac-dc31fe816d83 61096-0003 HUMAN OTC DRUG Sprayology AllergEase Allium cepa, apis mellifica, Aralia racemosa, Arundo mauritanica, Baptisia tinctoria, Echinacea, Euphrasia officinalis, gelsemium sempervirens, Histaminum hydrochloricum, Lycopodium clavatum, Rhus toxicodendron, Sabadilla, Sanguinaria canadensis, Urtica urens LIQUID ORAL 20140121 UNAPPROVED HOMEOPATHIC Eight and Company APIS MELLIFERA; ARALIA RACEMOSA ROOT; ARUNDO PLINIANA ROOT; BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; ONION; SANGUINARIA CANADENSIS ROOT; SCHOENOCAULON OFFICINALE SEED; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 3; 6; 30; 3; 4; 6; 200; 12; 6; 6; 200; 6; 200; 200 [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL 61096-0004_a47c1990-12ac-49c8-a955-95beef48417d 61096-0004 HUMAN OTC DRUG Sprayology Diet Power Apis mellifica, Bolda, Fucus vesiculosus, Galium aparine, Gambogia, Hamamelis virginiana, Hepar suis, Histaminum hydrochloricum, Pancreas suis, Thuja occidentalis LIQUID ORAL 20131230 UNAPPROVED HOMEOPATHIC Eight and Company APIS MELLIFERA; FUCUS VESICULOSUS; GALIUM APARINE; GAMBOGE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HISTAMINE DIHYDROCHLORIDE; PEUMUS BOLDUS LEAF; PORK LIVER; SUS SCROFA PANCREAS; THUJA OCCIDENTALIS LEAFY TWIG 6; 3; 3; 3; 3; 200; 3; 12; 12; 6 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL 61096-0005_62e34ec8-5f08-4156-845e-71ba1fa47c20 61096-0005 HUMAN OTC DRUG Sprayology DigestivEase Arsenicum album, Calcarea sulphurica, Carbo animalis, Carbo vegetabilis, Cinchona officinalis, Hydrastis canadensis, Nox vomica, Ornithogalum, Pyrogenium, Silicea LIQUID ORAL 20140317 UNAPPROVED HOMEOPATHIC Eight and Company ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; CALCIUM SULFATE ANHYDROUS; CARBO ANIMALIS; CINCHONA OFFICINALIS BARK; GOLDENSEAL; ORNITHOGALUM UMBELLATUM; RANCID BEEF; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED 12; 200; 200; 12; 200; 12; 12; 200; 12; 200 [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL 61096-0006_c99bab8a-7c6b-4c0d-b4e9-3c771ebc87c8 61096-0006 HUMAN OTC DRUG Sprayology Stress Relief Agnus castus, Avena sativa, Cinchona officinalis, Humulus lupulus, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Valeriana officinalis LIQUID ORAL 20140226 UNAPPROVED HOMEOPATHIC Eight and Company AVENA SATIVA FLOWERING TOP; CHASTE TREE; CINCHONA OFFICINALIS BARK; HOPS; HYOSCYAMUS NIGER; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS IGNATII SEED; VALERIAN 1; 6; 6; 2; 200; 3; 200; 3 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL 61096-0007_85d089f6-fa7d-472b-869f-bed96fae7be7 61096-0007 HUMAN OTC DRUG Sprayology TravelEase Apis mellifica, Carbo vegetabilis, Carduus marianus, Cocculus indicus, Ignatia amara, Nux vomica, Passiflora incarnata, Tabacum LIQUID ORAL 20140122 UNAPPROVED HOMEOPATHIC Eight and Company ACTIVATED CHARCOAL; ANAMIRTA COCCULUS SEED; APIS MELLIFERA; PASSIFLORA INCARNATA FLOWERING TOP; SILYBUM MARIANUM SEED; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 200; 30; 200; 1; 3; 200; 30; 6 [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL 61096-0012_3c425417-9d49-4110-904c-42f6ab0ee1ba 61096-0012 HUMAN OTC DRUG Sprayology Bone Builder Alfalfa, Arnica montana, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Cartilago suis, Hydrofluoricum acidum, Symphytum officinale LIQUID ORAL 20140311 UNAPPROVED HOMEOPATHIC Eight and Company ALFALFA; ARNICA MONTANA; CALCIUM FLUORIDE; COMFREY ROOT; HYDROFLUORIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SUS SCROFA CARTILAGE; TRIBASIC CALCIUM PHOSPHATE 1; 3; 30; 30; 30; 200; 6; 30 [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL 61096-0014_b5eafcf7-a376-4cf4-af7f-5369247471b8 61096-0014 HUMAN OTC DRUG Sprayology MenoPower Arnica montana, Glonoinum, Lachesis mutus, Oophorinum, Salvia officinalis, Sanguinaria canadensis, Sepia LIQUID ORAL 20140310 UNAPPROVED HOMEOPATHIC Eight and Company ARNICA MONTANA; LACHESIS MUTA VENOM; NITROGLYCERIN; SAGE; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SUS SCROFA OVARY 200; 200; 200; 1; 200; 200; 30 [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL 61096-0017_3fa483ae-e9c9-4b76-bc88-722dd1ddf3ce 61096-0017 HUMAN OTC DRUG Sprayology Body Skin Tonic Arsenicum album, Graphites, Mezereum, Radium bromatum, Rhus toxicodendron, Sulphur, Urtica urens LIQUID ORAL 20140205 UNAPPROVED HOMEOPATHIC Eight and Company ARSENIC TRIOXIDE; DAPHNE MEZEREUM BARK; GRAPHITE; RADIUM BROMIDE; SULFUR; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 30; 30; 30; 30; 6; 200; 200 [hp_C]/41mL; [arb'U]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL 61096-0022_6fac6ada-ba1b-437e-b3ad-5f17f64ff56d 61096-0022 HUMAN OTC DRUG Sprayology Hair and Nail Tonic Avena sativa, DNA, Elaeis guineensis, Glandula suprarenalis suis, Hamamelis virginiana, Hepar suis, Kali sulphuricum, Natrum muriaticum, Nicotinamidum, Phosphoricum acidum, Pituitarum posterium, Riboflavinum, Thiaminum hydrochloricum, Thuja occidentalis, Thyroidinum, Urtica urens LIQUID ORAL 20131108 UNAPPROVED HOMEOPATHIC Eight and Company AVENA SATIVA FLOWERING TOP; ELAEIS GUINEENSIS FRUIT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HERRING SPERM DNA; NIACINAMIDE; PHOSPHORIC ACID; PORK LIVER; POTASSIUM SULFATE; RIBOFLAVIN; SODIUM CHLORIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THIAMINE HYDROCHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; URTICA URENS 3; 10; 3; 12; 6; 3; 6; 30; 6; 200; 30; 8; 6; 200; 30; 3 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL 61096-0023_33f9f1ef-5cca-49fb-8f40-5080e956866e 61096-0023 HUMAN OTC DRUG Sprayology Life Detoxer Carduus marianus, Hepar suis, Mercurius solubilis, Mucosa nasalis suis, Plumbum metallicum LIQUID ORAL 20140225 UNAPPROVED HOMEOPATHIC Eight and Company LEAD; MERCURIUS SOLUBILIS; MILK THISTLE; PORK LIVER; SUS SCROFA NASAL MUCOSA 200; 200; 1; 6; 6 [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL 61096-0024_24086923-c1e3-4364-9f3d-6a79da6ee72d 61096-0024 HUMAN OTC DRUG Sprayology Snore Soother Antimonium tartaricum, Carbo vegetabilis, Mercurius corrosivus, Mucosa nasalis suis, Quebracho, Sticta pulmonaria, Teucrium marum LIQUID ORAL 20140318 UNAPPROVED HOMEOPATHIC Eight and Company ACTIVATED CHARCOAL; ANTIMONY POTASSIUM TARTRATE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; LOBARIA PULMONARIA; MERCURIC CHLORIDE; SUS SCROFA NASAL MUCOSA; TEUCRIUM MARUM 12; 200; 3; 200; 200; 6; 3 [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL 61096-0027_745b8751-8d81-4c88-a83d-5665f1e27826 61096-0027 HUMAN OTC DRUG Sprayology Acne Tonic Anthracinum, Antimonium crudum, Apis mellifica, Carbo animalis, Hamamelis virginiana, Hepar suis, Hydrocotyle asiatica, Kali bromatum, Mercurius corrosivus, Natrum sulphuratum, Pyrogenium, Radium bromatum, Sanguinaria canadensis, Sulphur iodatum, Thuja occidentalis, Urtica urens LIQUID ORAL 20140225 UNAPPROVED HOMEOPATHIC Eight and Company ANTIMONY TRISULFIDE; APIS MELLIFERA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; CARBO ANIMALIS; CENTELLA ASIATICA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MERCURIC CHLORIDE; PORK LIVER; POTASSIUM BROMIDE; RADIUM BROMIDE; RANCID BEEF; SANGUINARIA CANADENSIS ROOT; SODIUM SULFIDE NONAHYDRATE; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 30; 4; 200; 12; 30; 3; 200; 6; 30; 200; 30; 3; 200; 200; 200; 3 [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL 61096-0030_762a5374-e794-4b74-b7e1-40e1b33dcc44 61096-0030 HUMAN OTC DRUG Sprayology Party Relief Arsenicum album, Avena sativa, Bryonia, Capsicum annuum, Carbo animalis, Carduus marianus, Chelidonium majus, Hepar suis, Kali iodatum, Lapis albus, Radium bromatum, Taraxacum officinale, Thuja occidentalis LIQUID ORAL 20140321 UNAPPROVED HOMEOPATHIC Eight and Company ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BRYONIA ALBA ROOT; CALCIUM HEXAFLUOROSILICATE; CAPSICUM; CARBO ANIMALIS; CHELIDONIUM MAJUS; MILK THISTLE; PORK LIVER; POTASSIUM IODIDE; RADIUM BROMIDE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG 200; 1; 200; 200; 6; 200; 200; 1; 6; 200; 200; 1; 200 [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL 61096-0031_7e464b9c-8104-4191-bb09-488104e343eb 61096-0031 HUMAN OTC DRUG Sprayology PMS Support Apis mellifica, Chamomilla, Cimicifuga racemosa, Cuprum metallicum, Ignatia amara, Kali iodatum, Magnesia phosphorica, Oophorinum, Platinum metallicum, Sepia, Thuja occidentalis LIQUID ORAL 20140310 UNAPPROVED HOMEOPATHIC Eight and Company APIS MELLIFERA; BLACK COHOSH; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; PLATINUM; POTASSIUM IODIDE; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; SUS SCROFA OVARY; THUJA OCCIDENTALIS LEAFY TWIG 200; 6; 12; 9; 6; 12; 200; 9; 6; 30; 200 [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL 61096-0032_cb95da03-c8da-49ae-8bec-167b47a75aa4 61096-0032 HUMAN OTC DRUG Sprayology Arnica Power 3 Arnica montana LIQUID ORAL 20140122 UNAPPROVED HOMEOPATHIC Eight and Company ARNICA MONTANA 6 [hp_X]/41mL 61096-0033_ec02a9a8-afb5-4f6d-83dc-f0080cf018fb 61096-0033 HUMAN OTC DRUG Sprayology Brain Power Arnica montana, Baryta carbonica, Calcarea phosphorica, Ginkgo biloba, Hamamelis virginiana, Millefolium, Phosphoricum acidum LIQUID ORAL 20131105 UNAPPROVED HOMEOPATHIC Eight and Company ACHILLEA MILLEFOLIUM; ARNICA MONTANA; BARIUM CARBONATE; GINKGO; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PHOSPHORIC ACID; TRIBASIC CALCIUM PHOSPHATE 3; 3; 30; 6; 3; 30; 30 [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL 61096-0034_5837348e-c77c-4751-8198-54aa86549a93 61096-0034 HUMAN OTC DRUG Sprayology Woman Power Agnus castus, Aralia quinquefolia, Arnica montana, Damiana, Lactuca virosa, Natrum muriaticum, Onosmodium virginianum, Oophorinum, Phosphoricum acidum, Pituitarum posterium, Salix nigra, Sepia, Thuja occidentalis LIQUID ORAL 20140205 UNAPPROVED HOMEOPATHIC Eight and Company AMERICAN GINSENG; ARNICA MONTANA; CHASTE TREE; LACTUCA VIROSA; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; SALIX NIGRA BARK; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; TURNERA DIFFUSA LEAFY TWIG 2; 3; 3; 3; 30; 200; 3; 30; 30; 30; 12; 30; 2 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL 61096-0035_862afdae-3a04-4561-a6ca-f9ec584b99e5 61096-0035 HUMAN OTC DRUG Sprayology Rejuvenation Plus Aralia quinquefolia, Arnica montana, Avena sativa, Baryta carbonica, Carduus marianus, DNA, Hepar suis, Medulla ossis suis, Pancreas suis, Phosphoricum acidum, Pituitarum posterium, Thuja occidentalis LIQUID ORAL 20140317 UNAPPROVED HOMEOPATHIC Eight and Company AMERICAN GINSENG; ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; HERRING SPERM DNA; MILK THISTLE; PHOSPHORIC ACID; PORK LIVER; SUS SCROFA BONE MARROW; SUS SCROFA PANCREAS; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 6; 30; 12; 3; 3; 6; 6; 6; 30; 30 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL 61096-0038_22ba8561-5789-4192-9507-eba24073d67a 61096-0038 HUMAN OTC DRUG Sprayology ImmunoBooster Arsenicum album, Baptisia tinctoria, Echinacea, Medulla ossis suis, Mercurius corrosivus, Sulphur iodatum, thuja occidentalis LIQUID ORAL 20140317 UNAPPROVED HOMEOPATHIC Eight and Company ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; MERCURIC CHLORIDE; SULFUR IODIDE; SUS SCROFA BONE MARROW; THUJA OCCIDENTALIS LEAFY TWIG 200; 4; 4; 200; 200; 6; 200 [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL 61096-0039_c70e464b-8a82-4bd3-8448-d675979ff9d7 61096-0039 HUMAN OTC DRUG Sprayology Body Balance Aralia quinquefolia, Arnica montana, Carduus marianus, Elaeis guineensis, Glandula suprarenalis suis, Natrum muriaticum, Phosphoricum acidum, Thuja occidentalis LIQUID ORAL 20140226 UNAPPROVED HOMEOPATHIC Eight and Company AMERICAN GINSENG; ARNICA MONTANA; ELAEIS GUINEENSIS FRUIT; MILK THISTLE; PHOSPHORIC ACID; SODIUM CHLORIDE; SUS SCROFA ADRENAL GLAND; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 10; 3; 200; 30; 12; 200 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL 61098-010_c69762d1-30d5-4af4-86d8-5927192bedcc 61098-010 HUMAN OTC DRUG REVERDIR PTD Black Diamond Mask Allantoin PATCH TOPICAL 20140601 OTC MONOGRAPH FINAL part347 ADBIOTECH CO., LTD. ALLANTOIN .16 g/32g 61098-020_cb330fdb-c3a6-4669-9e20-44224dabb24d 61098-020 HUMAN OTC DRUG REVERDIR PTD ENERGY SERUM Allantoin CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 ADBIOTECH CO., LTD. ALLANTOIN .15 mg/30mL 61098-030_b52e2e8b-a67a-4479-9b20-4c6a4e292499 61098-030 HUMAN OTC DRUG REVERDIR PTD RENEW ESSENCE Allantoin CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 ADBIOTECH CO., LTD. ALLANTOIN .15 mg/30mL 61098-040_c19af9c6-7110-4c8d-95d6-f961c02ecfd6 61098-040 HUMAN OTC DRUG REVERDIR PTD REACTING Dimethicone CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 ADBIOTECH CO., LTD. DIMETHICONE .6 g/30g 61098-050_04a591b0-5a64-4e34-9d49-45b5a8f4b8b3 61098-050 HUMAN OTC DRUG REVERDIR AMPOULE 7mL Allantoin SOLUTION TOPICAL 20141001 OTC MONOGRAPH FINAL part347 ADBIOTECH CO., LTD. ALLANTOIN .175 mg/51 61112-001_5fe15bdb-f59f-4b87-8e5d-8a3d5683eb3d 61112-001 HUMAN PRESCRIPTION DRUG Omtryg omega-3-acid ethyl esters A CAPSULE ORAL 20140601 NDA NDA204977 Trygg Pharma Inc OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] 61119-1001_5566c682-871f-4d17-8b96-42a83da99334 61119-1001 HUMAN OTC DRUG Doctor-Clean SODIUM FLUORIDE MOUTHWASH DENTAL 20131116 OTC MONOGRAPH FINAL part355 Bowon Dental Co., Ltd SODIUM FLUORIDE .02 g/100mL 61126-003_fd135112-4330-42bd-ac2e-d3cd6f96325d 61126-003 HUMAN PRESCRIPTION DRUG Platinol cisplatin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120113 NDA NDA018057 Corden Pharma Latina S.p.A. CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 61126-004_d3e05034-cd9e-4dac-8c71-21f27772bf5e 61126-004 HUMAN PRESCRIPTION DRUG Platinol-AQ cisplatin INJECTION, SOLUTION INTRAVENOUS 20120113 NDA NDA018057 Corden Pharma Latina S.p.A. CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 61128-001_d09d0c3b-287a-4176-9c9f-43ebbe2ff4d3 61128-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20071201 UNAPPROVED MEDICAL GAS Wagner Welding Supply OXYGEN 992 L/1000L 61139-421_d36346f0-be43-4775-a538-8692d01aa6a8 61139-421 HUMAN OTC DRUG Highmark Professional Gold and Clean Antimicrobial Ltn Sp Chloroxylenol LIQUID TOPICAL 20131122 OTC MONOGRAPH NOT FINAL part333E Office Max, Inc. CHLOROXYLENOL .003 mg/mL 61139-422_59ffa252-e4ed-4b56-92ba-417e0c26f2a6 61139-422 HUMAN OTC DRUG HighMark Professional Pink Antimicrobial Ltn Sp Chloroxylenol LIQUID TOPICAL 20131122 OTC MONOGRAPH NOT FINAL part333E Office Max, Inc. CHLOROXYLENOL .003 mg/mL 61139-511_179b0425-5298-4875-a323-c818b85600b8 61139-511 HUMAN OTC DRUG Highmark Professional Antibacterial Foam Handwash Chloroxylenol LIQUID TOPICAL 20131122 OTC MONOGRAPH NOT FINAL part333E Office Max, Inc. CHLOROXYLENOL .003 mg/mL 61139-512_959db8ad-9d00-4b8d-a4a9-702164db866c 61139-512 HUMAN OTC DRUG Highmark Professional Luxury Foam Antibacterial Handwash Chloroxylenol LIQUID TOPICAL 20131122 OTC MONOGRAPH NOT FINAL part333E Office Max, Inc. CHLOROXYLENOL .003 mg/mL 61139-513_04f4d545-8851-4d48-a9c4-c5b065482e49 61139-513 HUMAN OTC DRUG Highmark Professional Premium Foam Antibacterial Handwash Chloroxylenol LIQUID TOPICAL 20131122 OTC MONOGRAPH NOT FINAL part333E Office Max, Inc. CHLOROXYLENOL .003 mg/mL 61159-000_f6c96b71-19ba-44f6-9950-f82670c50230 61159-000 HUMAN OTC DRUG Neptune E2 ANTISEPTIC FOAM HAND BENZALKONIUM CHLORIDE SOAP TOPICAL 20131114 OTC MONOGRAPH NOT FINAL part333E R. L. Williams Company BENZALKONIUM CHLORIDE 1.3 mg/mL 61159-001_bd1b9654-4da4-4f9a-ab45-f6b08893be92 61159-001 HUMAN OTC DRUG Neptune E2 ANTISEPTIC HAND BENZALKONIUM CHLORIDE SOAP TOPICAL 20131114 OTC MONOGRAPH NOT FINAL part333E R. L. Williams Company CHLOROXYLENOL 6 mg/mL 61164-1001_e7b2a8fc-fa82-496f-b328-f9c2a271143c 61164-1001 HUMAN OTC DRUG MOBARONA HAIR TONIC CURCUMA AROMATICA ROOT OIL LIQUID TOPICAL 20131123 UNAPPROVED DRUG OTHER Barona Co., Ltd CURCUMA AROMATICA ROOT OIL 15 g/100mL 61164-2001_f772ba99-4c5d-4df7-99f7-b0981c872798 61164-2001 HUMAN OTC DRUG S Balloon Slim Body Line HYDROGENATED SOYBEAN LIQUID TOPICAL 20140911 OTC MONOGRAPH FINAL part357C Barona Co., Ltd HYDROGENATED SOYBEAN OIL 2 g/100mL 61165-1001_cf307a34-7f79-4b34-b852-cab4b8058dc2 61165-1001 HUMAN OTC DRUG Lubas SILICON DIOXIDE PASTE, DENTIFRICE DENTAL 20131123 UNAPPROVED DRUG OTHER LUBASBIO CO., LTD SILICON DIOXIDE 17 g/100g 61165-2001_b4345f51-318f-4e21-bf36-8b7f72d1d981 61165-2001 HUMAN OTC DRUG ATO-K PANAX GINSENG ROOT OIL SOAP TOPICAL 20131123 UNAPPROVED DRUG OTHER LUBASBIO CO., LTD PANAX GINSENG ROOT OIL .5 g/100g 61197-000_8ae7f906-bb1a-412f-abf3-57a5879c309f 61197-000 HUMAN OTC DRUG Pacifica CC broad spectrum SPF 17 LIGHT ZINC OXIDE CREAM TOPICAL 20131121 OTC MONOGRAPH NOT FINAL part352 Pacifica Inc. ZINC OXIDE 114 mg/mL 61197-001_1ffd8362-15e8-40de-bdbb-bf6fcf61ac98 61197-001 HUMAN OTC DRUG Pacifica CC broad spectrum SPF 17 MEDIUM ZINC OXIDE CREAM TOPICAL 20131121 OTC MONOGRAPH NOT FINAL part352 Pacifica Inc. ZINC OXIDE 114 mg/mL 61219-001_79a636f3-7e2e-4f2a-bf0b-8eab2ed85e6b 61219-001 HUMAN OTC DRUG Flanax Antacid Aluminum Hydroxide, Magnesium Hydroxide, and Dimethicone LIQUID ORAL 20121206 OTC MONOGRAPH FINAL part331 Integrated Pharma Solutions ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 14.2; 1.4; 14.2 g/355mL; g/355mL; g/355mL 61220-001_bda2c93f-6b1f-4827-b6c6-e7572142c1f2 61220-001 HUMAN OTC DRUG Hydraday Octocrylene and Avobenzone CREAM TOPICAL 20131120 OTC MONOGRAPH NOT FINAL part352 PF Invest Company AVOBENZONE; OCTOCRYLENE 1.5; 2.5 mg/50mg; mg/50mg 61221-010_5224cd16-ccb8-4139-ad00-c596b582eed9 61221-010 HUMAN OTC DRUG NAAMAN Allantoin CREAM TOPICAL 20131101 OTC MONOGRAPH FINAL part347 LEADER GREEN CO., LTD. ALLANTOIN .25 mg/50mL 61221-020_5a5626dc-ff5a-453b-a928-c199cb0aee4b 61221-020 HUMAN OTC DRUG VASHTI Allantoin CREAM TOPICAL 20131101 OTC MONOGRAPH FINAL part347 LEADER GREEN CO., LTD. ALLANTOIN .25 mg/50mL 61223-101_204c8d4b-47d2-43c2-bc4c-3781893ba812 61223-101 HUMAN OTC DRUG COLD SORE SUPPORT ALLANTOIN, AVOBENZONE, MENTHOL, OCTINOXATE AND ZINC OXIDE LIPSTICK TOPICAL 20131201 OTC MONOGRAPH FINAL part347 MiraCell Inc ALLANTOIN; AVOBENZONE; MENTHOL; OCTINOXATE; ZINC OXIDE .75; 2.5; 1; 5.5; 3.5 g/100g; g/100g; g/100g; g/100g; g/100g 61238-1125_ff852f31-41e7-4569-8849-29fa82215edb 61238-1125 HUMAN OTC DRUG Miss Spa Hand Sanitiser GEL TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part333E Oriental Home Sense Co., Ltd. ALCOHOL 554 mL/554mL 61245-083_9b9251d5-3362-4218-aa4e-7a694968b228 61245-083 HUMAN OTC DRUG Conney Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20111114 20150401 ANDA ANDA075139 Conney Safety Products, LLC IBUPROFEN 200 mg/1 61245-100_56420fd6-7a16-456e-9b76-2fd1465e12a4 61245-100 HUMAN OTC DRUG Direct Safety Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130503 ANDA ANDA075139 Conney Safety Products, LLC IBUPROFEN 200 mg/1 61245-116_696aeb3b-521c-4465-b916-e73e5bddf408 61245-116 HUMAN OTC DRUG Direct Safety Aspirin Aspirin TABLET, FILM COATED ORAL 20130503 OTC MONOGRAPH FINAL part343 Conney Safety Products, LLC ASPIRIN 325 mg/1 61245-145_c5689016-b1de-4267-b39f-cfbe18e7abef 61245-145 HUMAN OTC DRUG Direct Safety Aspirin Free Acetaminophen TABLET, FILM COATED ORAL 20130531 OTC MONOGRAPH NOT FINAL part343 Conney Safety Products, LLC ACETAMINOPHEN 325 mg/1 61245-146_c5689016-b1de-4267-b39f-cfbe18e7abef 61245-146 HUMAN OTC DRUG Direct Safety Aspirin Free Acetaminophen TABLET, FILM COATED ORAL 20130531 OTC MONOGRAPH NOT FINAL part343 Conney Safety Products, LLC ACETAMINOPHEN 325 mg/1 61245-153_ae31ff95-6a1e-4677-a9a9-68d30ef02736 61245-153 HUMAN OTC DRUG Conney Aspirin Free Acetaminophen TABLET, FILM COATED ORAL 20111114 OTC MONOGRAPH NOT FINAL part343 Conney Safety Products, LLC ACETAMINOPHEN 325 mg/1 61245-154_358fae72-76e9-479b-964e-9f765f2c7903 61245-154 HUMAN OTC DRUG Conney Aspirin Free Acetaminophen TABLET, FILM COATED ORAL 20111114 OTC MONOGRAPH NOT FINAL part343 Conney Safety Products, LLC ACETAMINOPHEN 325 mg/1 61245-156_5c2e3fc1-b930-4e2c-b8c6-0d83394d55cc 61245-156 HUMAN OTC DRUG Conney Exra Strength Aspirin Free Acetaminophen TABLET, FILM COATED ORAL 20111114 OTC MONOGRAPH NOT FINAL part343 Conney Safety Products, LLC ACETAMINOPHEN 500 mg/1 61245-157_e8a5980d-9954-4200-8918-e359183dac96 61245-157 HUMAN OTC DRUG Conney Extra Strength Aspirin Free Acetaminophen TABLET, FILM COATED ORAL 20111114 OTC MONOGRAPH NOT FINAL part343 Conney Safety Products, LLC ACETAMINOPHEN 500 mg/1 61245-175_5f1373d1-858c-436f-b378-6864c0ba0524 61245-175 HUMAN OTC DRUG Direct Safety Extra Strength Aspirin Free Acetaminophen TABLET, FILM COATED ORAL 20130531 OTC MONOGRAPH NOT FINAL part343 Conney Safety Products, LLC ACETAMINOPHEN 500 mg/1 61245-176_5f1373d1-858c-436f-b378-6864c0ba0524 61245-176 HUMAN OTC DRUG Direct Safety Extra Strength Aspirin Free Acetaminophen TABLET, FILM COATED ORAL 20130531 OTC MONOGRAPH NOT FINAL part343 Conney Safety Products, LLC ACETAMINOPHEN 500 mg/1 61252-3005_45a08ce9-6958-4b03-bc7f-7a17b9fe0127 61252-3005 HUMAN PRESCRIPTION DRUG Nicotine UN1654 Nicotine UN1654 LIQUID ORAL 19970711 UNAPPROVED DRUG OTHER Nicobrand LTD NICOTINE 1 L/L Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient] 61252-3006_a3368095-95ba-491a-86d5-b1a65c788006 61252-3006 HUMAN PRESCRIPTION DRUG nicotine tartrate nicotine tartrate POWDER ORAL 19970711 UNAPPROVED DRUG OTHER Nicobrand LTD NICOTINE BITARTRATE ANHYDROUS 1 kg/kg Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient] 61254-1001_d74711ef-a43f-4e68-88e2-2e0688250289 61254-1001 HUMAN OTC DRUG HUM GLYCERIN CREAM TOPICAL 20131210 OTC MONOGRAPH FINAL part347 Happy Sonic Global Co., Ltd. GLYCERIN .1 g/100mL 61254-2001_cde18d5d-2539-415c-8832-021bb4390227 61254-2001 HUMAN OTC DRUG Coral S GLYCERIN SOAP TOPICAL 20140302 OTC MONOGRAPH FINAL part347 Happy Sonic Global Co., Ltd. GLYCERIN .1 g/100g 61254-3001_c795fd69-e1ea-4163-8b40-4a1524654091 61254-3001 HUMAN OTC DRUG Hum CC GLYCERIN CREAM TOPICAL 20140302 OTC MONOGRAPH FINAL part347 Happy Sonic Global Co., Ltd. GLYCERIN .1 g/100g 61254-4001_ed5ea553-58f6-4c5e-99ab-5918dcceeb25 61254-4001 HUMAN OTC DRUG Hum Body Liner GLYCERIN CREAM TOPICAL 20140302 OTC MONOGRAPH FINAL part347 Happy Sonic Global Co., Ltd. GLYCERIN .1 g/100g 61269-210_8da243b2-fa62-4e6f-a064-12d15e0eda29 61269-210 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20140505 NDA NDA021612 H2-Pharma, LLC FENOFIBRATE 50 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 61269-212_8da243b2-fa62-4e6f-a064-12d15e0eda29 61269-212 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20140505 NDA NDA021612 H2-Pharma, LLC FENOFIBRATE 150 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 61296-000_10cc3c34-8e0e-4bb7-9cb1-a45460f2267c 61296-000 HUMAN OTC DRUG BIOSOLIS Sun Milk UVA Sunscreen Face and Body Broad Spectrum SPF15 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part352 Pro Vera SA TITANIUM DIOXIDE; ZINC OXIDE 63.4; 48.5 mg/mL; mg/mL 61296-001_5530fc13-2a19-4660-b300-0538968d5d3c 61296-001 HUMAN OTC DRUG BIOSOLIS Sun Milk UVA Sunscreen Face and Body Broad Spectrum SPF30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part352 Pro Vera SA TITANIUM DIOXIDE; ZINC OXIDE 86.6; 63.1 mg/mL; mg/mL 61296-002_98401065-7d9b-4eac-ad19-753cd5f3d31d 61296-002 HUMAN OTC DRUG BIOSOLIS Sun Milk UVA Sunscreen Face and Body Broad Spectrum SPF50 KIDS TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part352 Pro Vera SA TITANIUM DIOXIDE; ZINC OXIDE 168; 97 mg/mL; mg/mL 61296-003_6c0817ac-af0e-4420-add9-468bbbb4ca50 61296-003 HUMAN OTC DRUG BIOSOLIS Extreme Fluid UVA Sunscreen Broad Spectrum Face and Neck SPF50 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part352 Pro Vera SA TITANIUM DIOXIDE; ZINC OXIDE 168; 97 mg/mL; mg/mL 61296-004_21c3ef95-444c-44d9-994d-e0ceccbaeac5 61296-004 HUMAN OTC DRUG BIOSOLIS Face UVA Sunscreen Broad Spectrum SPF30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part352 Pro Vera SA TITANIUM DIOXIDE; ZINC OXIDE 90; 67.9 mg/mL; mg/mL 61300-0001_381b38b5-bfeb-4c2a-b402-bcaa8a2fb5e6 61300-0001 HUMAN OTC DRUG MAX Abrotanum (Artemisia abrotanum), Anacardium orientale, Baryta muriatica, Calcarea carbonica, Calcarea phosphorica, Fucus vesiculosus, Graphites, Helleborus niger, SPRAY ORAL 20140430 UNAPPROVED HOMEOPATHIC Arize Supplements, LLC ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CHLORIDE DIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; FUCUS VESICULOSUS; GRAPHITE; HELLEBORUS NIGER ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MELATONIN; NIACINAMIDE; ONION; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK LIVER; SEMECARPUS ANACARDIUM JUICE; SEROTONIN HYDROCHLORIDE; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS IGNATII SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PANCREAS; SUS SCROFA TESTICLE; SUS SCROFA THYROID; THIAMINE HYDROCHLORIDE; THYMOL; TRIBASIC CALCIUM PHOSPHATE 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 61310-100_1c213dd4-6155-4172-9e13-5c84d5cf1c02 61310-100 HUMAN OTC DRUG MoReturn Hair Tonic Panthenol (0.2%), Biotin (0.06%) SPRAY TOPICAL 20131220 UNAPPROVED DRUG OTHER Moreand Co., Ltd. BIOTIN; PANTHENOL .06; .2 g/100mL; g/100mL 61310-101_791147fa-c1ee-456c-a814-7f73761baf35 61310-101 HUMAN OTC DRUG MoRreturn Hair Care Panthenol (0.2%), Biotin (0.06%) SHAMPOO TOPICAL 20131220 UNAPPROVED DRUG OTHER Moreand Co., Ltd. BIOTIN; PANTHENOL .3; 1 g/500mL; g/500mL 61310-102_30d49f6d-ef47-4bac-ac0e-dc570a7bdccc 61310-102 HUMAN OTC DRUG MoReturn Hair Panthenol, Biotin SHAMPOO TOPICAL 20131220 UNAPPROVED DRUG OTHER Moreand Co., Ltd. BIOTIN; PANTHENOL .3; 1 g/500mL; g/500mL 61312-001_53b6ff80-e9a8-4111-a6e7-539ba9e91124 61312-001 HUMAN OTC DRUG Hand Sanitizing wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20130314 OTC MONOGRAPH NOT FINAL part333A HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. BENZALKONIUM CHLORIDE .13 g/100g 61312-002_d026dc9f-8028-41e8-817f-517abac38bbe 61312-002 HUMAN OTC DRUG Hand Sanitizing wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20140924 OTC MONOGRAPH NOT FINAL part333A HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. BENZALKONIUM CHLORIDE .13 g/100g 61314-012_1f88e5a7-78c8-4f48-81bd-5fd664cee9c8 61314-012 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION OPHTHALMIC 20040514 ANDA ANDA076231 Falcon Pharmaceuticals, Ltd. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 61314-014_cb1cf616-d6c2-4a76-b4dd-4a64290a3415 61314-014 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION OPHTHALMIC 20080214 ANDA ANDA078031 Sandoz Inc DICLOFENAC SODIUM 1 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61314-015_b2235a46-f526-471e-8a9c-62f943ef6f7b 61314-015 HUMAN PRESCRIPTION DRUG Ofloxacin ofloxacin SOLUTION AURICULAR (OTIC) 20080331 ANDA ANDA078222 Falcon Pharmaceuticals, Ltd. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 61314-016_447a2a64-0507-4fe8-bb44-cc36c3916151 61314-016 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION OPHTHALMIC 20000605 ANDA ANDA080027 Falcon Pharmaceuticals, Ltd. PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] 61314-018_d68308ce-8a75-460b-b1a0-50614ae351a2 61314-018 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA078721 Sandoz Inc KETOROLAC TROMETHAMINE 4 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61314-019_5c7744eb-890b-3e4c-385c-33b142bbe815 61314-019 HUMAN PRESCRIPTION DRUG DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/ DROPS OPHTHALMIC 20090601 ANDA ANDA078981 Sandoz Inc. DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] 61314-030_32b50796-4dbf-fae7-e7d0-596bcabcb7cd 61314-030 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride and Timolol Maleate Dorzolamide Hydrochloride and Timolol Maleate SOLUTION OPHTHALMIC 20100102 ANDA ANDA090604 Sandoz Inc. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] 61314-044_574442fc-79d8-4c98-b391-c0409bff88fe 61314-044 HUMAN PRESCRIPTION DRUG Trifluridine trifluridine SOLUTION OPHTHALMIC 20010514 ANDA ANDA074311 Falcon Pharmaceuticals, Ltd. TRIFLURIDINE 10 mg/mL Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 61314-126_71bc1bc3-5f52-4294-af31-de84eeffbf72 61314-126 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA076583 Falcon Pharmaceuticals, Ltd. KETOROLAC TROMETHAMINE 5 mg/mL 61314-143_2d66fa03-f6c8-4eac-9f78-5072ef84e3d3 61314-143 HUMAN PRESCRIPTION DRUG Brimonidine Tartrate Brimonidine Tartrate SOLUTION OPHTHALMIC 20030917 ANDA ANDA076254 Sandoz Inc BRIMONIDINE TARTRATE 2 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 61314-144_d3bb4638-7801-4dd3-b923-23a7e5bb04ce 61314-144 HUMAN PRESCRIPTION DRUG Brimonidine Tartrate Brimonidine Tartrate SOLUTION OPHTHALMIC 20101002 NDA NDA021764 Sandoz Inc BRIMONIDINE TARTRATE 1.5 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 61314-203_53fa0b7a-f982-48a7-92c4-6f098683c1ed 61314-203 HUMAN PRESCRIPTION DRUG PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION OPHTHALMIC 19960221 NDA NDA200890 Falcon Pharmaceuticals, Ltd. PILOCARPINE HYDROCHLORIDE 10 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 61314-204_53fa0b7a-f982-48a7-92c4-6f098683c1ed 61314-204 HUMAN PRESCRIPTION DRUG PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION OPHTHALMIC 19960221 NDA NDA200890 Falcon Pharmaceuticals, Ltd. PILOCARPINE HYDROCHLORIDE 20 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 61314-206_53fa0b7a-f982-48a7-92c4-6f098683c1ed 61314-206 HUMAN PRESCRIPTION DRUG PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride SOLUTION OPHTHALMIC 19960221 NDA NDA200890 Falcon Pharmaceuticals, Ltd. PILOCARPINE HYDROCHLORIDE 40 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 61314-224_0f73e198-2e58-4bfb-8ff8-ad913d75a05e 61314-224 HUMAN PRESCRIPTION DRUG Timolol GFS timolol maleate SOLUTION, GEL FORMING, EXTENDED RELEASE OPHTHALMIC 19981224 NDA NDA020963 Sandoz Inc TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 61314-225_0f73e198-2e58-4bfb-8ff8-ad913d75a05e 61314-225 HUMAN PRESCRIPTION DRUG Timolol GFS timolol maleate SOLUTION, GEL FORMING, EXTENDED RELEASE OPHTHALMIC 19981224 NDA NDA020963 Sandoz Inc TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 61314-226_488d2e04-1fbe-4bb3-bd3f-f3d6e0c5f32e 61314-226 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION OPHTHALMIC 19960115 ANDA ANDA074261 Sandoz Inc TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 61314-227_488d2e04-1fbe-4bb3-bd3f-f3d6e0c5f32e 61314-227 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION OPHTHALMIC 19960115 ANDA ANDA074262 Sandoz Inc TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 61314-229_6de7ad08-8e96-4853-a617-a6d896fa7dba 61314-229 HUMAN PRESCRIPTION DRUG Levobunolol Hydrochloride Levobunolol Hydrochloride SOLUTION OPHTHALMIC 19970130 ANDA ANDA074850 Sandoz Inc LEVOBUNOLOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 61314-237_d0c5f8f0-bcea-497c-bbad-0cba6c608ecf 61314-237 HUMAN PRESCRIPTION DRUG Cromolyn Sodium Cromolyn Sodium SOLUTION/ DROPS OPHTHALMIC 19990629 ANDA ANDA075282 Sandoz Inc CROMOLYN SODIUM 40 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] 61314-238_f507500a-ed39-301f-8e85-ae898a81a313 61314-238 HUMAN PRESCRIPTION DRUG Carteolol Hydrochloride Carteolol Hydrochloride SOLUTION OPHTHALMIC 20000105 ANDA ANDA075476 Sandoz Inc. CARTEOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 61314-245_2c681cb2-e1db-4348-ba8d-4481e601ca45 61314-245 HUMAN PRESCRIPTION DRUG Betaxolol Hydrochloride Betaxolol Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20000515 NDA AUTHORIZED GENERIC NDA019270 Sandoz Inc BETAXOLOL HYDROCHLORIDE 5.6 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 61314-294_b7a09f68-4a8f-4689-b932-99fd1c7b9791 61314-294 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION OPHTHALMIC 20040701 ANDA ANDA088771 Sandoz Inc DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61314-297_f0f52b95-0d34-43a0-b9da-cb2da4ad68d4 61314-297 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium and Prednisolone Sodium Phosphate Sulfacetamide Sodium and Prednisolone Sodium Phosphate SOLUTION OPHTHALMIC 20040309 ANDA ANDA073630 Falcon Pharmaceuticals, Ltd. PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM 2.5; 100 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61314-303_394e36f0-cc8e-2045-8bb4-5f55d906b1ea 61314-303 HUMAN PRESCRIPTION DRUG Atropine Sulfate atropine sulfate SOLUTION OPHTHALMIC 20000630 UNAPPROVED DRUG OTHER FALCON LABORATORY LTD ATROPINE SULFATE 1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 61314-308_6945fb86-27fb-4bab-8908-98772c6269c5 61314-308 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride azelastine hydrochloride SOLUTION/ DROPS INTRAOCULAR 20130321 ANDA ANDA202305 Sandoz Inc AZELASTINE HYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 61314-320_6393e997-7080-4ce6-8a34-2f80b48f5a3a 61314-320 HUMAN PRESCRIPTION DRUG Olopatadine Hydrochloride olopatadine hydrochloride SPRAY, METERED NASAL 20120630 NDA AUTHORIZED GENERIC NDA021861 Falcon Pharmaceuticals, Ltd. OLOPATADINE HYDROCHLORIDE 665 ug/100uL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 61314-342_758a4a58-c3bd-04fe-0aba-c4e33f39ff53 61314-342 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride SOLUTION OPHTHALMIC 20000630 UNAPPROVED DRUG OTHER FALCON LABORATORY LTD PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 61314-354_094f011a-f374-1597-38aa-e4d69e9bf174 61314-354 HUMAN PRESCRIPTION DRUG Tropicamide Tropicamide SOLUTION OPHTHALMIC 20000609 ANDA ANDA084305 Sandoz Inc. TROPICAMIDE 5 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 61314-355_094f011a-f374-1597-38aa-e4d69e9bf174 61314-355 HUMAN PRESCRIPTION DRUG Tropicamide Tropicamide SOLUTION OPHTHALMIC 20000613 ANDA ANDA084306 Sandoz Inc. TROPICAMIDE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 61314-395_c1b44f91-356d-4804-9509-3b457f4809e5 61314-395 HUMAN PRESCRIPTION DRUG Cyclopentolate Hydrochloride Cyclopentolate Hydrochloride SOLUTION OPHTHALMIC 20020822 ANDA ANDA084109 Falcon Pharmaceuticals, Ltd. CYCLOPENTOLATE HYDROCHLORIDE 5 mg/mL 61314-396_c1b44f91-356d-4804-9509-3b457f4809e5 61314-396 HUMAN PRESCRIPTION DRUG Cyclopentolate Hydrochloride Cyclopentolate Hydrochloride SOLUTION OPHTHALMIC 20020822 ANDA ANDA084110 Falcon Pharmaceuticals, Ltd. CYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL 61314-397_c1b44f91-356d-4804-9509-3b457f4809e5 61314-397 HUMAN PRESCRIPTION DRUG Cyclopentolate Hydrochloride Cyclopentolate Hydrochloride SOLUTION OPHTHALMIC 20020822 ANDA ANDA084108 Falcon Pharmaceuticals, Ltd. CYCLOPENTOLATE HYDROCHLORIDE 20 mg/mL 61314-447_7b9dcce8-eee0-4805-8652-cde9548a5e5f 61314-447 HUMAN PRESCRIPTION DRUG Metipranolol Metipranolol SOLUTION/ DROPS OPHTHALMIC 20010809 ANDA ANDA075720 Falcon Pharmaceuticals, Ltd. METIPRANOLOL 3 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 61314-547_22b2871b-8083-4e41-88f7-68a67f4c797e 61314-547 HUMAN PRESCRIPTION DRUG Latanoprost Latanoprost SOLUTION OPHTHALMIC 20110107 ANDA ANDA091449 Sandoz Inc LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 61314-628_cb0ac4cf-047b-4c0e-9380-74913c1a6551 61314-628 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim SOLUTION OPHTHALMIC 19980416 ANDA ANDA064211 Falcon Pharmaceuticals, Ltd. POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 61314-630_c3f678a7-cb06-4998-b09c-7e987ea61c4b 61314-630 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone neomycin sulfate, polymyxin b sulfate and dexamethasone SUSPENSION OPHTHALMIC 19960221 ANDA ANDA062341 Falcon Pharmaceuticals, Ltd. DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61314-631_7f2e3c46-9f39-45e7-99a9-64cc4f6f649d 61314-631 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin and Polymyxin B Sulfates and Dexamethasone OINTMENT OPHTHALMIC 19960221 NDA AUTHORIZED GENERIC NDA050065 Falcon Pharmaceuticals, Ltd. DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [iU]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61314-633_53c582bc-f0a4-4c8e-9470-1382c902ad67 61314-633 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION OPHTHALMIC 19960405 ANDA ANDA062196 Sandoz Inc GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 61314-637_9f38ad78-0522-4569-a654-5026da2846a4 61314-637 HUMAN PRESCRIPTION DRUG Prednisolone Acetate Prednisolone Acetate SUSPENSION OPHTHALMIC 19941215 NDA AUTHORIZED GENERIC NDA017469 Falcon Pharmaceuticals PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61314-641_91fa5151-1d6e-40da-81ab-b2eb9da61770 61314-641 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate and hydrocortisone SUSPENSION OPHTHALMIC 20030509 ANDA ANDA062874 Falcon Pharmaceuticals, Ltd. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61314-643_d30cac1d-3d75-afb1-ee8c-39c9a2056f2b 61314-643 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 19950109 ANDA ANDA062535 Sandoz Inc. TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 61314-645_3c999bc7-004e-426f-a04f-f9ddcbb32e6a 61314-645 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate and hydrocortisone SUSPENSION AURICULAR (OTIC) 20030317 ANDA ANDA062488 Falcon Pharmaceuticals, Ltd. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61314-646_ff34da77-5e96-4ed1-8c28-ba0b2f35576a 61314-646 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate and hydrocortisone SOLUTION AURICULAR (OTIC) 20030318 ANDA ANDA062423 Falcon Pharmaceuticals, Ltd. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [iU]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61314-647_66a324da-9e9f-4683-8775-cc21838e0a04 61314-647 HUMAN PRESCRIPTION DRUG Tobramycin and Dexamethasone Tobramycin and Dexamethasone SUSPENSION OPHTHALMIC 20090102 NDA AUTHORIZED GENERIC NDA050592 Falcon Pharmaceuticals DEXAMETHASONE; TOBRAMYCIN 1; 3 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61314-656_7ea442a6-15b2-4d9d-9150-3063c52f1fcb 61314-656 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride SOLUTION OPHTHALMIC 20040507 NDA AUTHORIZED GENERIC NDA019992 Falcon Pharmaceuticals, Ltd. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 61314-665_9afbb4e3-06bc-4435-9db5-ce5d2073a71c 61314-665 HUMAN PRESCRIPTION DRUG Apraclonidine Apraclonidine SOLUTION OPHTHALMIC 20090719 NDA AUTHORIZED GENERIC NDA020258 Falcon Pharmaceuticals, Ltd. APRACLONIDINE HYDROCHLORIDE 5.75 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 61314-701_a3e9d913-8e3e-441c-89d2-23c5a1b15cff 61314-701 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SOLUTION OPHTHALMIC 20030325 ANDA ANDA089560 Falcon Pharmaceuticals, Ltd. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 61315-010_f467eaba-25e3-44cc-b9dc-2bc5fccb009a 61315-010 HUMAN OTC DRUG Arllin Golden Combination Charisma CC Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Golden Bridge International OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 2.9; .88 mg/30mL; mg/30mL; mg/30mL 61324-464_62cb7b43-231c-46e9-bbae-733d587630b5 61324-464 HUMAN OTC DRUG Ausanil capsaicin ginger SPRAY, METERED NASAL 20140314 UNAPPROVED HOMEOPATHIC VR1 Corporation CAPSICUM SPP.; GINGER 3; 3 [hp_X]/8mL; [hp_X]/8mL 61327-0015_4f2fccd8-70ba-4cfe-a31e-617c5f981768 61327-0015 HUMAN OTC DRUG Instant Hand Sanitizer TENNder CARE ETHYL ALCOHOL GEL TOPICAL 20131210 OTC MONOGRAPH NOT FINAL part333E AMC Promotional Products ALCOHOL 62 mL/100mL 61328-001_535621dd-c4e6-47c0-8f02-0c4698acb61a 61328-001 HUMAN OTC DRUG Diaper Rash Balm Skin Protectant OINTMENT TOPICAL 20131209 OTC MONOGRAPH FINAL part347 Skinfix, Inc. ZINC OXIDE .2 g/g 61328-001_ceef5837-e43b-48bf-a886-41e8dc9effdc 61328-001 HUMAN OTC DRUG Diaper Rash Balm Skin Protectant OINTMENT TOPICAL 20131209 OTC MONOGRAPH FINAL part347 Skinfix, Inc. ZINC OXIDE .2 g/g 61328-002_58c2fa29-0298-4b5c-a3cd-1b99a0beed14 61328-002 HUMAN OTC DRUG Body Repair Balm Skin Protectant OINTMENT TOPICAL 20131209 OTC MONOGRAPH FINAL part347 Skinfix, Inc. ZINC OXIDE .15 g/g 61328-002_81e52fec-6c63-4206-b51a-e599986e9224 61328-002 HUMAN OTC DRUG Body Repair Balm Skin Protectant OINTMENT TOPICAL 20131209 OTC MONOGRAPH FINAL part347 Skinfix, Inc. ZINC OXIDE .15 g/g 61328-003_3c278795-b0d0-419b-ab85-840e48d42681 61328-003 HUMAN OTC DRUG Rapid Repair Balm Skin Protectant OINTMENT TOPICAL 20131209 OTC MONOGRAPH FINAL part347 Skinfix, Inc. ZINC OXIDE .2 g/g 61328-003_943a6652-680c-4187-b9f3-05d495fed885 61328-003 HUMAN OTC DRUG Rapid Repair Balm Skin Protectant OINTMENT TOPICAL 20131209 OTC MONOGRAPH FINAL part347 Skinfix, Inc. ZINC OXIDE .2 g/g 61328-004_1faa5c88-283d-458a-9663-e978813974d5 61328-004 HUMAN OTC DRUG Gentle Eczema Balm Skin Protectant OINTMENT TOPICAL 20131209 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL .02 g/g 61328-004_92216a2f-0a84-4f97-887f-9710f1b5ee25 61328-004 HUMAN OTC DRUG Gentle Eczema Balm Skin Protectant OINTMENT TOPICAL 20131209 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL .02 g/g 61328-005_e6656c26-bc28-42b7-8c19-7417c64795e0 61328-005 HUMAN OTC DRUG Kids Eczema Balm Skin Protectant OINTMENT TOPICAL 20140409 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL .02 g/g 61328-006_7d1dc06e-6215-40d9-b8e3-948e646eb623 61328-006 HUMAN OTC DRUG Hand Repair Cream Skin Protectant CREAM TOPICAL 20140702 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL .01 g/g 61328-006_b36a2311-c9ad-486b-b6bc-f45ab00a72b7 61328-006 HUMAN OTC DRUG Hand Repair Cream Skin Protectant CREAM TOPICAL 20140702 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL .01 g/g 61328-007_2169491b-cda3-403b-8a5f-de3ea8d5ce69 61328-007 HUMAN OTC DRUG Healing Foot and Leg Balm Skin Protectant OINTMENT TOPICAL 20131219 OTC MONOGRAPH FINAL part347 Skinfix, Inc. ALLANTOIN .02 g/g 61333-201_e0c7faeb-80b2-4039-8c7e-2bdd3ca6834e 61333-201 HUMAN OTC DRUG Lights Povidone Iodine Solution POVIDONE-IODINE SOLUTION TOPICAL 20140222 OTC MONOGRAPH FINAL part333C Lights Medical Manufacture Co., Ltd. POVIDONE-IODINE 1.18 g/118mL 61333-202_41e4a364-3d6f-4f01-8f5d-669d1669bf68 61333-202 HUMAN OTC DRUG Lights Povidone Iodine Solution POVIDONE-IODINE SOLUTION TOPICAL 20140322 OTC MONOGRAPH FINAL part333C Lights Medical Manufacture Co., Ltd. POVIDONE-IODINE 1.18 g/118mL 61336-001_7d497849-67ad-43c3-b9bf-050175048a84 61336-001 HUMAN PRESCRIPTION DRUG Oxygen, Compressed OXYGEN LIQUID RESPIRATORY (INHALATION) 20120524 UNAPPROVED MEDICAL GAS Gulf State Chemical and Welding Supply Inc. OXYGEN 1 L/L 61352-001_e7b38b45-1081-4732-9e2d-cb7f074e0a27 61352-001 HUMAN OTC DRUG Clinicians Complex Sulfur LOTION TOPICAL 20131211 OTC MONOGRAPH FINAL part333D Cosmed, Inc. SULFUR 100 mg/g 61352-002_d48988ac-b15d-47f5-8f50-a0af3957d925 61352-002 HUMAN OTC DRUG facematter Sulfur LOTION TOPICAL 20131211 20151204 OTC MONOGRAPH FINAL part333D Cosmed, Inc. SULFUR 100 mg/g 61352-003_229c52ec-235f-4a11-a73e-58cf26e0f656 61352-003 HUMAN OTC DRUG Total Sun Protection Octinoxate, Zinc Oxide, Octisalate, Oxybenzone LOTION TOPICAL 20130801 OTC MONOGRAPH FINAL part352 Cosmed, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 75; 30; 30; 38 mg/g; mg/g; mg/g; mg/g 61355-569_b4e44dcb-765c-40dc-87be-4c7bc3bfbd09 61355-569 HUMAN OTC DRUG Toppik Womens Hair Regrowth Treatment Minoxidil SOLUTION TOPICAL 20140101 ANDA ANDA078176 Spencer Forrest, Inc. MINOXIDIL 20 mg/mL 61355-570_3525ff6e-0a3c-443d-8729-8d36399fd70c 61355-570 HUMAN OTC DRUG Toppik Mens Hair Regrowth Treatment Extra Strength Minoxidil SOLUTION TOPICAL 20140101 ANDA ANDA076239 Spencer Forrest, Inc. MINOXIDIL 50 mg/mL 61357-130_0639fa84-e31c-45f7-ad6a-cae2099e321b 61357-130 HUMAN OTC DRUG Hemorrodil Unguento Zinc Oxide OINTMENT RECTAL 19640301 OTC MONOGRAPH FINAL part346 ZURICH MEDICAL LABS, LLC ZINC OXIDE 50 mg/g 61357-135_5a877b42-8cce-4c0a-a2ef-3324577ad4d2 61357-135 HUMAN OTC DRUG Hemorrodil PHENYLEPHRINE HYDROCHLORIDE and COCOA BUTTER SUPPOSITORY RECTAL 19640301 OTC MONOGRAPH FINAL part346 ZURICH MEDICAL LABS, LLC COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 1768.8; 5 mg/1; mg/1 61357-146_39fa6269-46d0-476f-8516-310465dcc67e 61357-146 HUMAN OTC DRUG Sanafitil Undecylenic Acid LIQUID TOPICAL 19660824 OTC MONOGRAPH FINAL part333C ZURICH MEDICAL LABS, LLC UNDECYLENIC ACID 100 mg/mL 61357-149_e56542a5-1348-43e0-b28f-8056e4b8cdd1 61357-149 HUMAN OTC DRUG Sanafitil Undecylenic Acid OINTMENT TOPICAL 19660824 OTC MONOGRAPH FINAL part333C ZURICH MEDICAL LABS, LLC UNDECYLENIC ACID 100 mg/g 61357-152_4b57c6de-c555-41a0-8789-4cc84a62f16b 61357-152 HUMAN OTC DRUG Sanafitil Talco UNDECYLENIC ACID and ZINC UNDECYLENATE POWDER TOPICAL 19660824 OTC MONOGRAPH FINAL part333C ZURICH MEDICAL LABS, LLC UNDECYLENIC ACID; ZINC UNDECYLENATE 20; 200 mg/g; mg/g 61360-1351_9880db7c-4fdf-42b4-b415-67c224f7838a 61360-1351 HUMAN PRESCRIPTION DRUG Ciclopirox ciclopirox SHAMPOO TOPICAL 20110223 ANDA ANDA090269 Taro Pharmaceuticals, Inc. CICLOPIROX 10 mg/.96mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 61360-2002_d8b394a8-0f31-474c-b38e-958c0739bf5c 61360-2002 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 19950601 OTC MONOGRAPH FINAL part333C Taro Pharmaceuticals, Inc. CLOTRIMAZOLE 1 g/100g 61360-2020_15ae5419-e1b9-4192-a427-358f1c57d31f 61360-2020 HUMAN OTC DRUG Tolnaftate Tolnaftate CREAM TOPICAL 20090820 OTC MONOGRAPH FINAL part333 Taro Pharmaceuticals, Inc. TOLNAFTATE 1 g/100g 61360-2037_690e7ad8-e3d1-493c-b0d8-9d5ee36afbb4 61360-2037 HUMAN OTC DRUG Clotrimazole Clotrimazole SOLUTION TOPICAL 19960501 OTC MONOGRAPH FINAL part333C Taro Pharmaceuticals, Inc. CLOTRIMAZOLE 1 g/mL 61362-2150_e1541825-4194-4176-bb03-cd078f2a7b7a 61362-2150 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Reliance Oxygen & Equipment OXYGEN 99 L/100L 61369-101_dad83518-f493-487f-ac54-8595bd600bbe 61369-101 HUMAN OTC DRUG KLENSKIN SHOWERON SUNSCREEN SPF-30 AVOBENZONE, OCTOCRYLENE, OCTINOXATE GEL TOPICAL 20140728 OTC MONOGRAPH FINAL part352 CoLabs Intl. Corp AVOBENZONE; OCTINOXATE; OCTOCRYLENE 2.75; 7.2; 7.04 g/100mL; g/100mL; g/100mL 61380-259_d430f830-c59a-4726-b143-45a3ec2b2970 61380-259 HUMAN OTC DRUG Natures Gate Mineral Kids Block SPF 20 TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20100323 OTC MONOGRAPH NOT FINAL part352 Levlad LLC TITANIUM DIOXIDE; ZINC OXIDE 80; 20 mg/mL; mg/mL 61380-264_f630400c-871d-4f4b-950c-5eef72631314 61380-264 HUMAN OTC DRUG Natures Gate Face Block SPF 25 Fragrance-Free Octinoxate, Octisalate, Octocrylene, and Zinc Oxide LOTION TOPICAL 20100412 OTC MONOGRAPH NOT FINAL part352 Levlad LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 75; 50; 60; 40 mg/mL; mg/mL; mg/mL; mg/mL 61380-277_c87a86ae-0b8d-41c6-a3f7-ed787ac03ced 61380-277 HUMAN OTC DRUG Natures Gate aqua block SPF 50 OCTINOXATE, OCTISALATE, OCTOCRYLENE, and ZINC OXIDE LOTION TOPICAL 20110304 OTC MONOGRAPH NOT FINAL part352 Levlad, LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 75; 50; 70; 69 mg/mL; mg/mL; mg/mL; mg/mL 61380-278_b871213f-e018-4392-a9fd-22de4b11ae41 61380-278 HUMAN OTC DRUG Natures Gate Sport Block SPF 50 OCTINOXATE, OCTISALATE, OCTOCRYLENE, and ZINC OXIDE LOTION TOPICAL 20110304 OTC MONOGRAPH NOT FINAL part352 Levlad LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 75; 50; 70; 69 mg/mL; mg/mL; mg/mL; mg/mL 61380-279_e11031cd-9312-4e37-b8c6-acc608dc10ec 61380-279 HUMAN OTC DRUG Natures Gate kids block SPF 50 OCTINOXATE, OCTISALATE, OCTOCRYLENE, and ZINC OXIDE LOTION TOPICAL 20110324 OTC MONOGRAPH NOT FINAL part352 Levlad, LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 75; 50; 70; 69 mg/mL; mg/mL; mg/mL; mg/mL 61380-310_1b676602-6ba2-40a3-a029-9f3d39dac798 61380-310 HUMAN OTC DRUG Natures Gate Kids SPF 20 Mineral TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20120612 OTC MONOGRAPH NOT FINAL part352 Levlad, LLC TITANIUM DIOXIDE; ZINC OXIDE 83; 20 mg/mL; mg/mL 61380-311_ce1529a4-e01c-48df-add6-3a398462637a 61380-311 HUMAN OTC DRUG Natures Gate Sport SPF 20 Mineral TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 Levlad, LLC TITANIUM DIOXIDE; ZINC OXIDE 83; 20 mg/mL; mg/mL 61380-312_5c2eb043-410b-4af2-b578-327853259c41 61380-312 HUMAN OTC DRUG Natures Gate Aqua SPF 50 OCTINOXATE, OCTISALATE, OCTOCRYLENE, and ZINC OXIDE LOTION TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part352 Levlad, LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 75; 50; 70; 69 mg/mL; mg/mL; mg/mL; mg/mL 61380-313_8106605e-0ad4-4f0d-a996-58eda0a21c20 61380-313 HUMAN OTC DRUG Natures Gate Sport SPF 50 Octinoxate, Octisalate, Octocrylene, and Zinc Oxide LOTION TOPICAL 20120614 OTC MONOGRAPH NOT FINAL part352 Levlad, LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 75; 50; 70; 69 mg/mL; mg/mL; mg/mL; mg/mL 61380-314_2cf5cb52-307d-4197-80fa-0775283d6b51 61380-314 HUMAN OTC DRUG Natures Gate kids SPF 50 octinoxate, octisalate, octocrylene, and zinc oxide LOTION TOPICAL 20120615 OTC MONOGRAPH NOT FINAL part352 Levlad LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 75; 50; 70; 69 mg/mL; mg/mL; mg/mL; mg/mL 61383-201_d2af787c-c2f5-40bd-bfdc-cd3dc5aa4846 61383-201 HUMAN OTC DRUG Photo Plasma Titanium Dioxide CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Dimensional Merchandising Inc. TITANIUM DIOXIDE 4.2 g/100mL 61387-247_3463e075-077a-4a93-b74f-bc676267909d 61387-247 HUMAN OTC DRUG TrueLipids Anti-Itch Barrier Hydrocortisone CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part348 DermDeal, LLC dba Cheryl Lee, MD Sensitive Skin Care HYDROCORTISONE 1 g/100mL 61387-248_83b18be0-6c2e-4b1a-b425-7be334fd1d44 61387-248 HUMAN OTC DRUG White Petrolatum CheryLee MD Sensitive Skin Care TrueLipids Double Action Boo-Boo Bum OINTMENT TOPICAL 20140301 OTC MONOGRAPH FINAL part346 DermDeal, LLC DBA CheryLee MD, Sensitive Skin Care PETROLATUM 50 g/100g 61387-249_33aa7bf1-83fe-45c5-b830-13daf85b696f 61387-249 HUMAN OTC DRUG White Petrolatum CheryLee MD Sensitive Skin Care TrueLipids Relieve and Protect Ointment OINTMENT TOPICAL 20140301 OTC MONOGRAPH FINAL part346 DermDeal, LLC DBA CheryLee MD, Sensitive Skin Care PETROLATUM 50 g/100g 61387-250_5c86e748-c532-4bd6-9628-bbc5e8fd2cef 61387-250 HUMAN OTC DRUG White Petrolatum CherylLee MD Sensitive Skin Care TrueLipids TrueLips Lip Balm OINTMENT TOPICAL 20140301 OTC MONOGRAPH FINAL part346 DermDeal, LLC DBA CheryLee MD, Sensitive Skin Care PETROLATUM 50 g/100g 61398-0828_57fb5499-18d5-44b5-9477-7e04e8f8e08d 61398-0828 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19941001 UNAPPROVED MEDICAL GAS Complete Care Inc OXYGEN 99 L/100L 61403-010_d4847220-ee6b-4cd0-8db1-623178f5d4fd 61403-010 HUMAN OTC DRUG Ceravine Lip Balm OATMEAL STICK TOPICAL 20131101 OTC MONOGRAPH FINAL part347 Biostandard Inc. OATMEAL .0003 g/4.25g 61420-0001_dfb3f082-be0e-41db-ac31-a180886990c2 61420-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19940501 UNAPPROVED MEDICAL GAS Dillon Medical Supply OXYGEN 99 L/100L 61442-101_04edcdf2-0d3d-2fd8-e054-00144ff8d46c 61442-101 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 Carlsbad Technology, Inc. DICLOFENAC SODIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61442-102_04edcdf2-0d3d-2fd8-e054-00144ff8d46c 61442-102 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 Carlsbad Technology, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61442-103_04edcdf2-0d3d-2fd8-e054-00144ff8d46c 61442-103 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 Carlsbad Technology, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61442-111_c20401ad-f903-4887-a26e-51207d5ab066 61442-111 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20091022 ANDA ANDA075090 Carlsbad Technology, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 61442-112_05a086ae-783a-39ad-e054-00144ff88e88 61442-112 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20091022 ANDA ANDA075382 Carlsbad Technology, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 61442-113_05a086ae-783a-39ad-e054-00144ff88e88 61442-113 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20091022 ANDA ANDA075382 Carlsbad Technology, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 61442-115_36c1dd39-d1ae-4076-b3e8-e99d75d042b0 61442-115 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20100201 ANDA ANDA077911 Carlsbad Technology, Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 61442-116_36c1dd39-d1ae-4076-b3e8-e99d75d042b0 61442-116 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20100201 ANDA ANDA077911 Carlsbad Technology, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 61442-117_36c1dd39-d1ae-4076-b3e8-e99d75d042b0 61442-117 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20100201 ANDA ANDA077911 Carlsbad Technology, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 61442-121_88518123-8f7b-4eb7-a1a1-a94c7d422141 61442-121 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Carlsbad Technology, Inc FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 61442-122_88518123-8f7b-4eb7-a1a1-a94c7d422141 61442-122 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Carlsbad Technology, Inc FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 61442-126_683306f1-b4ef-4982-822b-39aaf280c114 61442-126 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100630 ANDA ANDA077918 Carlsbad Technology, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61442-127_683306f1-b4ef-4982-822b-39aaf280c114 61442-127 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100630 ANDA ANDA077918 Carlsbad Technology, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61442-141_03e83a82-6e52-3ec0-e054-00144ff88e88 61442-141 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Carlsbad Technology, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 61442-142_03e83a82-6e52-3ec0-e054-00144ff88e88 61442-142 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Carlsbad Technology, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 61442-143_03e83a82-6e52-3ec0-e054-00144ff88e88 61442-143 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Carlsbad Technology, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 61442-161_af92ea41-b5dd-433d-9c09-b103240f2853 61442-161 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20101015 ANDA ANDA065152 Carlsbad Technology, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 61442-162_af92ea41-b5dd-433d-9c09-b103240f2853 61442-162 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20101015 ANDA ANDA065152 Carlsbad Technology, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 61442-171_ed9409c5-a7e7-4684-83ba-286581a79cbd 61442-171 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor CAPSULE ORAL 20080731 ANDA ANDA065146 Carlsbad Technology, Inc. CEFACLOR 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 61442-172_ed9409c5-a7e7-4684-83ba-286581a79cbd 61442-172 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor CAPSULE ORAL 20080731 ANDA ANDA065146 Carlsbad Technology, Inc. CEFACLOR 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 61442-173_58b43cb7-d360-4ef5-bbef-a4b81af7c1ff 61442-173 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor SUSPENSION ORAL 20120327 ANDA ANDA065412 Carlsbad Technology, Inc. CEFACLOR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 61442-174_58b43cb7-d360-4ef5-bbef-a4b81af7c1ff 61442-174 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor SUSPENSION ORAL 20120327 ANDA ANDA065412 Carlsbad Technology, Inc. CEFACLOR 187 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 61442-175_58b43cb7-d360-4ef5-bbef-a4b81af7c1ff 61442-175 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor SUSPENSION ORAL 20120327 ANDA ANDA065412 Carlsbad Technology, Inc. CEFACLOR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 61442-176_58b43cb7-d360-4ef5-bbef-a4b81af7c1ff 61442-176 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor SUSPENSION ORAL 20120327 ANDA ANDA065412 Carlsbad Technology, Inc. CEFACLOR 375 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 61442-201_e3757196-10ac-43b5-8ce1-2da9cbda14c9 61442-201 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin SUSPENSION ORAL 20090601 ANDA ANDA065336 Carlsbad Technology, Inc. CEPHALEXIN 125 mg/5mL 61442-202_e3757196-10ac-43b5-8ce1-2da9cbda14c9 61442-202 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin SUSPENSION ORAL 20090601 ANDA ANDA065336 Carlsbad Technology, Inc. CEPHALEXIN 250 mg/5mL 61442-222_0a57c231-67d3-5574-e054-00144ff88e88 61442-222 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20091010 ANDA ANDA076126 Carlsbad Technology, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 61442-223_0a57c231-67d3-5574-e054-00144ff88e88 61442-223 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20091010 ANDA ANDA076126 Carlsbad Technology, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 61442-224_0a57c231-67d3-5574-e054-00144ff88e88 61442-224 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20091010 ANDA ANDA076126 Carlsbad Technology, Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 61442-231_51078aee-25dc-4573-96b1-dd00ef401a4e 61442-231 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET ORAL 20070423 ANDA ANDA077990 Carlsbad Technology, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 61442-232_51078aee-25dc-4573-96b1-dd00ef401a4e 61442-232 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET ORAL 20070423 ANDA ANDA077990 Carlsbad Technology, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 61442-321_1ed5d45e-e600-456e-982f-5cf97cc9dbcf 61442-321 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20130617 ANDA ANDA202297 Carlsbad Technology, Inc CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 61442-322_1ed5d45e-e600-456e-982f-5cf97cc9dbcf 61442-322 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20130617 ANDA ANDA202297 Carlsbad Technology, Inc CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 61442-323_1ed5d45e-e600-456e-982f-5cf97cc9dbcf 61442-323 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20130617 ANDA ANDA202297 Carlsbad Technology, Inc CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 61442-361_a26d7693-8f02-4632-bc4e-027b0d3d9982 61442-361 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140201 ANDA ANDA203769 Carlsbad Technology, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 61442-362_a26d7693-8f02-4632-bc4e-027b0d3d9982 61442-362 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140201 ANDA ANDA203769 Carlsbad Technology, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 61442-363_a26d7693-8f02-4632-bc4e-027b0d3d9982 61442-363 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140201 ANDA ANDA203769 Carlsbad Technology, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 61447-001_7225bec3-b7ee-447a-9e67-18e52ee380ef 61447-001 HUMAN OTC DRUG Corn Removers salicylic acid PLASTER TOPICAL 20140301 OTC MONOGRAPH FINAL part358H Cuxson Gerrard & Co Ltd SALICYLIC ACID 40 mg/1 61458-0001_629f28d9-3a88-475c-b59a-32bfe3f374d7 61458-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19960601 UNAPPROVED MEDICAL GAS Quality Home Healthcare, Inc. OXYGEN 99 L/100L 61476-100_51f15dda-1861-4b68-872d-49cee7c8dce4 61476-100 HUMAN OTC DRUG Zenol Cool METHYL SALICYLATE POULTICE TRANSDERMAL 20131123 OTC MONOGRAPH NOT FINAL part348 Green Cross Corp METHYL SALICYLATE 160 mg/17g 61476-101_be85476e-1c35-4857-b175-aaffe82d172a 61476-101 HUMAN OTC DRUG Zenol Mild Hot METHYL SALICYLATE POULTICE TRANSDERMAL 20131203 OTC MONOGRAPH NOT FINAL part348 Green Cross Corp METHYL SALICYLATE 105 mg/17.5g 61476-102_797676cd-4dd3-40d9-9e43-dedb508341fb 61476-102 HUMAN OTC DRUG Hanbang Cataplasma MENTHOL POULTICE TRANSDERMAL 20131203 OTC MONOGRAPH NOT FINAL part348 Green Cross Corp MENTHOL 280 mg/12g 61477-101_95b1485e-961b-405d-a889-740553edb245 61477-101 HUMAN OTC DRUG ALOE ICE SUNBURN RELIEF JELLY LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part348 Aloe Care International, LLC LIDOCAINE HYDROCHLORIDE 2 g/100mL 61477-201_229ecf20-6297-4efa-a2ed-0af94c6e1bf0 61477-201 HUMAN OTC DRUG ALOE ICE SPF 20 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 4; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL 61477-203_715a6523-282a-4a5e-b0bf-bffff3d5f5db 61477-203 HUMAN OTC DRUG ALOE ICE SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 5; 6; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 61477-205_11fe2359-3fea-48d0-b79a-7e8288e1fd5d 61477-205 HUMAN OTC DRUG ALOE UP LIL KIDS SPF 50 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 5; 6; 5; 10 g/100mL; g/100mL; 1/100mL; g/100mL; 1/100mL 61477-206_ceea504c-bd03-4956-ac6f-3ad7431d45ac 61477-206 HUMAN OTC DRUG ALOE UP LIL KIDS CONTINUOUS SUNSCREEN SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.75; 4 g/100mL; g/100mL; g/100mL; g/100mL; 1/100mL 61477-207_7a11e8c7-0894-43e4-b833-9e03707f7359 61477-207 HUMAN OTC DRUG ALOE UP PRO 15 AVOBENZONE, OCTISALATE, OCTOCRYLENE SPRAY TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 1.85 g/100mL; g/100mL; g/100mL 61477-208_40958abf-4714-4a95-8ea4-ea83f482ad92 61477-208 HUMAN OTC DRUG ALOE UP PRO SPF 30 ULTRA SPORT SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 3.5 g/100mL; g/100mL; g/100mL; g/100mL 61477-209_4e90c283-1fba-4559-863d-d8538d76479f 61477-209 HUMAN OTC DRUG ALOE UP PRO 30 CONTINUOUS SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.75; 2 g/100mL; g/100mL; g/100mL; g/100mL; 1/100mL 61477-210_9194139a-3a2f-4a8a-95ee-67a1d8423ee4 61477-210 HUMAN OTC DRUG ALOE UP PRO SPF 50 ADVANCED FORMULA ULTRA SPORT SUNSCREEN AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 5; 6; 5; 10 g/100mL; g/100mL; 1/100mL; g/100mL; g/100mL 61477-211_434dc135-c15d-4659-b09d-57ca52542eee 61477-211 HUMAN OTC DRUG ALOE UP PRO 50 CONTINUOUS SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.75; 4 g/100mL; g/100mL; g/100mL; g/100mL; 1/100mL 61477-213_6c783b07-f206-4e61-87ef-28472af86147 61477-213 HUMAN OTC DRUG ALOE UP SUNSCREEN SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE LOTION TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 5; 6; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL; 1/100mL 61477-214_79ce1137-5081-4d95-a1db-e7888d0296fc 61477-214 HUMAN OTC DRUG ALOE UP NATURAL LIP ICE SUNSCREEN OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC OCTINOXATE; OXYBENZONE 2; 4.5 g/100g; 1/100g 61477-215_abd00ab9-675a-4d0f-95cc-a2535d1221cc 61477-215 HUMAN OTC DRUG ALOE UP MEDICATED LIP BALM SPF 30 HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC HOMOSALATE; MERADIMATE; OCTINOXATE; OXYBENZONE 6; 4; 7.5; 5 1/100g; 1/100g; g/100g; 1/100g 61477-216_0b9a4b5d-18a6-4454-9c4f-a0217a51775f 61477-216 HUMAN OTC DRUG ALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN OCTINOXATE, OXYBENZONE SPRAY TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC OCTINOXATE; OXYBENZONE 2; 2 g/100mL; 1/100mL 61480-124_b637ccef-b141-4731-84c3-97586c7110f8 61480-124 HUMAN PRESCRIPTION DRUG Psorizide Ultra Potassium Bromide, Nickel Sulfate, and Zinc Bromide TABLET ORAL 19971001 UNAPPROVED HOMEOPATHIC Plymouth Pharmaceuticals Inc dba Loma Lux Laboratories NICKEL SULFATE; POTASSIUM BROMIDE; ZINC BROMIDE 1; 1; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 61480-127_60d9722a-de33-4086-8898-6eb371722463 61480-127 HUMAN PRESCRIPTION DRUG Eczemol Potassium Bromide, Nickel Sulfate, and Sulfur TABLET ORAL 20011115 UNAPPROVED HOMEOPATHIC Plymouth Pharmaceuticals Inc NICKEL SULFATE; POTASSIUM BROMIDE; SULFUR 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 61480-137_eedb71b8-e44e-49d3-88df-6134d5cfc0e4 61480-137 HUMAN PRESCRIPTION DRUG Acunol Nickel Sulfate, Potassium Bromide, Sodium Bromide, Zinc Sulfate Anhydrous, and Sulfur TABLET ORAL 20060418 UNAPPROVED HOMEOPATHIC Plymouth Pharmaceuticals Inc NICKEL SULFATE; POTASSIUM BROMIDE; SODIUM BROMIDE; SULFUR; ZINC SULFATE ANHYDROUS 1; 1; 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 61480-255_d1165151-13c5-47ce-bc64-549840840b1b 61480-255 HUMAN PRESCRIPTION DRUG Psorizide Forte Nickel Sulfate, Potassium Bromide, and Fumaric Acid TABLET ORAL 20011115 UNAPPROVED HOMEOPATHIC Plymouth Pharmaceuticals Inc FUMARIC ACID; NICKEL SULFATE; POTASSIUM BROMIDE 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 61481-0020_4040fe2f-0096-44bc-9ce6-259612eeebfe 61481-0020 HUMAN OTC DRUG KINeSYS Analgesic Sport METHYL SALICYLATE and MENTHOL STICK TOPICAL 20120531 OTC MONOGRAPH NOT FINAL part348 KINeSYS Pharmaceutical Inc. MENTHOL; METHYL SALICYLATE 15; 30 g/100g; g/100g 61481-0037_0285d3fa-c9c9-4bc8-9883-b6331066dec3 61481-0037 HUMAN OTC DRUG KINeSYS EarthKind SPF 30 Sunscreen ZINC OXIDE OINTMENT TOPICAL 20110201 OTC MONOGRAPH FINAL part352 KINeSYS Pharmaceutical Inc. ZINC OXIDE 250 g/1000g 61481-0045_b79aab66-3716-4c7a-be5d-f2c1a1e689f3 61481-0045 HUMAN OTC DRUG KINESYS SPF 30 SOLID SUNSCREEN OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE STICK TOPICAL 20120620 OTC MONOGRAPH NOT FINAL part352 KINeSYS Pharmaceutical Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 5; 4.5; 1 g/100g; g/100g; g/100g; g/100g 61481-0450_b0ce5b9c-f86d-4410-b49c-94987e60ff0a 61481-0450 HUMAN OTC DRUG KINESYS Broad Spectrum SPF 15 Alcohol-Free Sunscreen OCTINOXATE, OCTISALATE, and AVOBENZONE SPRAY TOPICAL 20120530 OTC MONOGRAPH NOT FINAL part352 KINeSYS Pharmaceutical Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 2; 7.5; 5 g/100mL; g/100mL; g/100mL 61481-0560_c76dfff8-5da2-4f1d-b42c-b36419eab9b8 61481-0560 HUMAN OTC DRUG Kinesys Broad Spectrum SPF 30 Alcohol-Free Sunscreen OCTINOXATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE SPRAY TOPICAL 20120530 OTC MONOGRAPH NOT FINAL part352 KINeSYS Pharmaceutical Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 7.5; 4; 7 g/100mL; g/100mL; g/100mL; g/100mL 61481-0590_c7d07b9e-4d24-41c6-9e74-5afbc0f2f0e3 61481-0590 HUMAN OTC DRUG Kinesys Broad Spectrum SPF 30 KiDS Alcohol-Free Sunscreen OCTINOXATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE SPRAY TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part352 KINeSYS Pharmaceutical Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 7.5; 4; 7 g/100mL; g/100mL; g/100mL; g/100mL 61481-0660_c860700a-cb98-4f70-84cb-af9ea0ed243b 61481-0660 HUMAN OTC DRUG Kinesys Broad Spectrum SPF 30 girl Alcohol-Free Sunscreen OCTINOXATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE SPRAY TOPICAL 20120530 OTC MONOGRAPH NOT FINAL part352 KINeSYS Pharmaceutical Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 7.5; 4; 7 g/100mL; g/100mL; g/100mL; g/100mL 61481-0670_21cb8598-01cc-4cdc-a88e-414cf853743a 61481-0670 HUMAN OTC DRUG Kinesys Broad Spectrum SPF 30 Alcohol-Free Performance Sunscreen Fragrance-Free OCTINOXATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE SPRAY TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part352 KINeSYS Pharmaceutical Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 7.5; 4; 7 g/100mL; g/100mL; g/100mL; g/100mL 61481-0680_4ac8e8cb-fbdc-4b9e-80de-60c6618d4651 61481-0680 HUMAN OTC DRUG KINESYS SPF 50 Funscreen Sunscreen for Kids HOMOSALATE, OXYBENZONE, OCTISALATE, and AVOBENZONE SPRAY TOPICAL 20120620 OTC MONOGRAPH NOT FINAL part352 KINeSYS Pharmaceutical Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 15; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL 61481-3001_853a783b-af5a-459f-a2e2-35f54afa8a72 61481-3001 HUMAN OTC DRUG Kinesys Broad Spectrum SPF 30 Alcohol-Free Performance Sunscreen - Fragrance Free OCTINOXATE, OCTOCRYLENE, OCTISALATE, and Avobenzone SPRAY TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 KINeSYS Pharmaceuticals Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2.5; 7.5; 5; 7.5 g/100mL; g/100mL; g/100mL; g/100mL 61481-3002_95bc88d5-7e9e-421a-b03c-9c0ccdc8b511 61481-3002 HUMAN OTC DRUG Kinesys Broad Spectrum SPF 30 Kids Alcohol-Free Sunscreen OCTINOXATE, OCTOCRYLENE, OCTISALATE, and Avobenzone SPRAY TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 KINeSYS Pharmaceuticals Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2.5; 7.5; 5; 7.5 g/100mL; g/100mL; g/100mL; g/100mL 61481-3003_915fa1a0-794f-4f7b-968e-17fb7017c416 61481-3003 HUMAN OTC DRUG Kinesys Broad Spectrum SPF 30 Alcohol-Free Sunscreen - Mango Scent OCTINOXATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE SPRAY TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 KINeSYS Pharmaceuticals Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2.5; 7.5; 5; 7.5 g/100mL; g/100mL; g/100mL; g/100mL 61481-3004_3f9a4073-1c42-4374-bbec-347fbbef07dd 61481-3004 HUMAN OTC DRUG Kinesys Broad Spectrum SPF 30 Girl Alcohol-Free Sunscreen OCTINOXATE, OCTOCRYLENE, OCTISALATE, and Avobenzone SPRAY TOPICAL 20130304 OTC MONOGRAPH NOT FINAL part352 KINeSYS Pharmaceuticals Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2.5; 7.5; 5; 7.5 g/100mL; g/100mL; g/100mL; g/100mL 61500-5527_f93cb03d-1bcf-4293-b720-91cdf58052c5 61500-5527 HUMAN OTC DRUG Topricin Aesculus hippocastanum, Arnica montana, Belladonna, Crotalus horridus, Echinacea, Graphites, Heloderma, Lachesis mutus, Naja tripudians, Rhus toxicodendron, Ruta graveolens CREAM TOPICAL 20120110 UNAPPROVED HOMEOPATHIC Topical BioMedics, Inc. AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; ATROPA BELLADONNA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 8; 6; 6; 8; 8; 8; 6; 6 [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g 61500-5587_e77e7b72-847e-48df-93cc-3e20bdd234dd 61500-5587 HUMAN OTC DRUG My Pain Away Aesculus hippocastanum, Arnica montana, Belladonna, Crotalus horridus, Echinacea, Graphites, Heloderma, Lachesis mutus, Naja tripudians, Rhus toxicodendron, Ruta graveolens CREAM TOPICAL 20141001 UNAPPROVED HOMEOPATHIC Topical BioMedics, Inc. AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; ATROPA BELLADONNA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 8; 6; 6; 8; 8; 8; 6; 6 [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL 61504-000_37906041-267e-42d6-947a-f4ee52cb50bb 61504-000 HUMAN OTC DRUG Iris Antimicrobial Hand CHLOROXYLENOL SOAP TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333A Amerifoods Trading Company CHLOROXYLENOL 3 mg/mL 61504-001_ae6cc4b7-ea7d-42b8-b84b-26efd4134e82 61504-001 HUMAN OTC DRUG Iris Antimicrobial Hand CHLOROXYLENOL SOAP TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333A Amerifoods Trading Company CHLOROXYLENOL 3 mg/mL 61504-002_107f938c-d831-46aa-bcfe-19e5c2465c61 61504-002 HUMAN OTC DRUG First Street Dishwasing Concentrate and Antimicrobial Hand CHLOROXYLENOL SOAP TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333A Amerifoods Trading Company CHLOROXYLENOL 3 mg/mL 61504-030_67a61f4a-80ed-4a8b-9bfa-e7bb364ca769 61504-030 HUMAN OTC DRUG IRIS ISOPROPYL ALCOHOL LIQUID TOPICAL 20141001 OTC MONOGRAPH FINAL part344 AMERIFOODS TRADING COMPANY ISOPROPYL ALCOHOL 70 g/100g 61504-033_8a5ab2fd-3ee0-4e72-b949-2ad820a5d4f9 61504-033 HUMAN OTC DRUG IRIS HYDROGEN PEROXIDE LIQUID TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A AMERIFOODS TRADING COMPANY HYDROGEN PEROXIDE 3 g/100g 61509-101_2b48f7bc-39a0-424a-ba51-22393fe54894 61509-101 HUMAN OTC DRUG Mark 3 Benzocaine GEL DENTAL; ORAL 20140228 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g 61509-102_a716a174-6697-4419-a050-4f5e3bc32f70 61509-102 HUMAN OTC DRUG Mark 3 Benzocaine GEL DENTAL; ORAL 20140228 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g 61509-103_eb5d685a-0193-452f-98c0-c0061b87219b 61509-103 HUMAN OTC DRUG Mark 3 Benzocaine GEL DENTAL; ORAL 20140228 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g 61509-104_7a0b280c-71fb-4924-b522-f3db6db92696 61509-104 HUMAN OTC DRUG Mark 3 Benzocaine GEL DENTAL; ORAL 20140303 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g 61509-105_db52a040-49e8-442a-9120-bf79f3fb6c92 61509-105 HUMAN OTC DRUG Mark 3 Benzocaine GEL DENTAL; ORAL 20140303 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g 61509-106_329f3a09-1ad7-4237-bf75-8135aee85b30 61509-106 HUMAN OTC DRUG Mark 3 Benzocaine GEL DENTAL; ORAL 20140303 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g 61509-107_b10b96b7-934b-4dae-8913-6b5fdfb83a77 61509-107 HUMAN OTC DRUG Mark 3 Benzocaine Gel GEL DENTAL; ORAL 20140303 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g 61509-108_067ed54e-7092-407e-a3f8-14f126480325 61509-108 HUMAN OTC DRUG Mark 3 Benzocaine GEL DENTAL; ORAL 20120303 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g 61509-109_52a942d1-9198-44c2-aae9-e79af55857ff 61509-109 HUMAN OTC DRUG Mark 3 Benzocaine GEL DENTAL; ORAL 20140303 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g 61515-101_ed09b1ed-d0ef-4135-9db6-dc57e0d46ab7 61515-101 HUMAN OTC DRUG UNIQUE NATURAL PREMIUM SHEA BUTTER SHEA BUTTER CREAM TOPICAL 20131229 UNAPPROVED HOMEOPATHIC NATURAL COSMETICS INDUSTRY LTD SHEA BUTTER 99.5 g/100g 61515-103_03045514-54b2-45b3-9833-c1e45ba795c7 61515-103 HUMAN OTC DRUG UNIQUE NATURAL PREMIUM SHEA BUTTER Fragrance-Free SHEA BUTTER CREAM TOPICAL 20131229 UNAPPROVED HOMEOPATHIC NATURAL COSMETICS INDUSTRY LTD SHEA BUTTER 99.5 g/100g 61519-001_4de47c52-9e79-461f-be46-56109d55b395 61519-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20131231 UNAPPROVED MEDICAL GAS Shasta Medical Equipment OXYGEN 99 L/100L 61520-001_4924d35f-58e0-4b07-857e-75e50b46e92e 61520-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20131227 UNAPPROVED MEDICAL GAS Premier Medical Distribution OXYGEN 99 L/100L 61526-1001_63bcb496-4dda-4cb7-b8c0-b5fab0e50217 61526-1001 HUMAN OTC DRUG SoonSoo gargle SODIUM FLUORIDE MOUTHWASH DENTAL 20131116 OTC MONOGRAPH FINAL part355 Chang Hwa Dang Co., Ltd. SODIUM FLUORIDE .02 g/100mL 61543-1082_2d9d1d62-843e-4bbe-be62-cdd8fcb3bb0a 61543-1082 HUMAN OTC DRUG Sudden Change Intensive Restoration Daily Moisturizer SPF 15 ZINC OXIDE, OCTINOXATE CREAM TOPICAL 20110918 OTC MONOGRAPH FINAL part352 CCA Industries Inc OCTINOXATE; ZINC OXIDE 6; 2 mL/100mL; mL/100mL 61543-1515_bf40f3b0-590f-48df-8732-0fd870e8442a 61543-1515 HUMAN OTC DRUG SOLAR SENSE CLEAR ZINC SUNSCREEN FACE and BODY BROAD SPECTRUM SPF 50 OCTISALATE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20130805 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 50; 145 mg/mL; mg/mL; mg/mL 61543-1545_bb6276da-fa6e-412a-a1f3-a77b620c62c3 61543-1545 HUMAN OTC DRUG SOLAR SENSE CLEAR ZINC SUNSCREEN FACE and LIPS BROAD SPECTRUM SPF 50 OCTISALATE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 14.5 g/100g; g/100g; g/100g 61543-1601_0c154433-23ac-4183-a32b-720ce3921b17 61543-1601 HUMAN OTC DRUG Bikini Zone Medicated CREME LIDOCAINE CREAM TOPICAL 20100603 OTC MONOGRAPH FINAL part333B CCA Industries, Inc. LIDOCAINE 2 g/100g 61543-1604_73d387ba-069c-42fd-9620-7677c45cb477 61543-1604 HUMAN OTC DRUG Bikini Zone Medicated LIDOCAINE GEL TOPICAL 20100604 OTC MONOGRAPH FINAL part333B CCA Industries, Inc. LIDOCAINE 2 g/100g 61543-1613_a92d757b-07d4-4c46-87dc-f280ef335811 61543-1613 HUMAN OTC DRUG Bikini Zone Medicated CREME LIDOCAINE CREAM TOPICAL 20100604 OTC MONOGRAPH FINAL part333B CCA Industries, Inc. LIDOCAINE 2 g/100g 61543-1644_d7a8421d-9772-45f6-a152-06e5c7f99fec 61543-1644 HUMAN OTC DRUG Bikini Zone MEDICATED After Shave Fresh Scent PRAMOXINE HYDROCHLORIDE SPRAY TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part348 CCA Industries, Inc. PRAMOXINE HYDROCHLORIDE 10 mg/mL 61543-1752_ed054332-0b4c-4b72-8893-3abda2adbb6b 61543-1752 HUMAN OTC DRUG SOLAR SENSE CLEAR ZINC SUNSCREEN FACE and LIPS BROAD SPECTRUM SPF 70 OCTINOXATE, OCTOCRYLENE, ZINC OXIDE CREAM TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 4.5; 8; 14.5 g/100g; g/100g; g/100g 61543-1758_ec1686a1-3848-4ef0-9345-70e213d5e428 61543-1758 HUMAN OTC DRUG SOLAR SENSE CLEAR ZINC SUNSCREEN Baby Tear Free FACE and BODY BROAD SPECTRUM SPF 50 PLUS OCTISALATE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 50; 145 mg/mL; mg/mL; mg/mL 61543-1772_2f8dae78-3d11-437d-b4f7-8c55d6e6852b 61543-1772 HUMAN OTC DRUG SOLAR SENSE CLEAR ZINC SUNSCREEN BROAD SPECTRUM SPF 50 Plus OCTISALATE, OCTINOXATE, ZINC OXIDE STICK TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 14.5 g/100g; g/100g; g/100g 61543-1774_5a9fe880-c83b-4ec5-88f4-05ca309310cf 61543-1774 HUMAN OTC DRUG SOLAR SENSE CLEAR ZINC SUNSCREEN SPORT BROAD SPECTRUM SPF 50 Plus OCTISALATE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 14.5 g/100g; g/100g; g/100g 61543-2285_76ab6950-f507-43f9-bcc4-7b314a349a7f 61543-2285 HUMAN OTC DRUG Nutra Nail FUNGI FREE Antifungal Treatment UNDECYLENIC ACID LIQUID TOPICAL 20140813 OTC MONOGRAPH FINAL part333C CCA Industries, Inc UNDECYLENIC ACID 250 mg/mL 61543-3130_802a5cac-e074-4c77-87f8-2daecce25b85 61543-3130 HUMAN OTC DRUG PAIN BUST R II MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20111223 OTC MONOGRAPH FINAL part348 CCA Industries, Inc. MENTHOL; METHYL SALICYLATE 12; 18 g/100g; g/100g 61543-6087_cea60fd8-bc82-4af0-b8d0-769b5f13d61f 61543-6087 HUMAN OTC DRUG Scar Zone Topical Scar Diminishing DIMETHICONE, ZINC OXIDE, OCTINOXATE CREAM TOPICAL 20100614 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. DIMETHICONE; OCTINOXATE; ZINC OXIDE 4; 7.5; 4 g/100g; g/100g; g/100g 61543-6168_3d7c7855-6830-4659-bc66-a18415c7356e 61543-6168 HUMAN OTC DRUG SCAR ZONE ACNE SALICYLIC ACID CREAM TOPICAL 20100614 OTC MONOGRAPH FINAL part333D CCA Industries, Inc. SALICYLIC ACID 2 g/100g 61543-6169_c871f6db-0b7a-4e2f-a34b-85d17ce1a67a 61543-6169 HUMAN OTC DRUG Scar Zone Burn Extra Strength Burn Relief Topical Analgesic and Antiseptic LIDOCAINE, BENZALKONIUM CHLORIDE GEL TOPICAL 20100701 OTC MONOGRAPH FINAL part333B CCA Industries, Inc. BENZALKONIUM CHLORIDE; LIDOCAINE .13; 2 g/100g; g/100g 61543-6174_e5943078-ebf4-4244-b804-1584b7473308 61543-6174 HUMAN OTC DRUG Scar Zone Burn Topical Analgesic and Antiseptic LIDOCAINE, BENZALKONIUM CHLORIDE GEL TOPICAL 20100614 OTC MONOGRAPH FINAL part333B CCA Industries, Inc. BENZALKONIUM CHLORIDE; LIDOCAINE .13; 2 g/100g; g/100g 61543-7224_101ae850-aaea-4b80-8bae-4d6708467165 61543-7224 HUMAN OTC DRUG Plus White Coffee Drinkers Whitening SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100612 OTC MONOGRAPH FINAL part333 CCA Industries, Inc. SODIUM MONOFLUOROPHOSPHATE .884 g/100g 61543-7233_e459ca3e-c961-482e-96f6-8efa2f456a22 61543-7233 HUMAN OTC DRUG Plus White With Peroxide SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100609 OTC MONOGRAPH FINAL part333 CCA Industries, Inc. SODIUM MONOFLUOROPHOSPHATE .884 g/100g 61543-7236_d83a1080-d5c8-4db2-bf8f-cfa1174d222f 61543-7236 HUMAN OTC DRUG Plus Plus White Smokers Whitening SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100611 OTC MONOGRAPH FINAL part333 CCA Industries, Inc. SODIUM MONOFLUOROPHOSPHATE .884 g/100g 61543-7237_e88a1553-7d5e-45a1-ad0f-5a3105eef9c0 61543-7237 HUMAN OTC DRUG Plus White Xtra SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100611 OTC MONOGRAPH FINAL part333 CCA Industries, Inc. SODIUM MONOFLUOROPHOSPHATE .884 g/100g 61543-7240_1f608fa2-3df3-4fb9-87bd-c13e1db6e613 61543-7240 HUMAN OTC DRUG Plus White Super White TOOTH with PEROXIDE SODIUM MONOFLUOROPHOSPHATE PASTE ORAL 20130801 OTC MONOGRAPH FINAL part355 CCA Industries, Inc. SODIUM MONOFLUOROPHOSPHATE .884 g/100g 61543-7243_4ae6080b-6a3f-436a-9166-91609029c66b 61543-7243 HUMAN OTC DRUG Plus White Xtra Whitening SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100611 OTC MONOGRAPH FINAL part333 CCA Industries, Inc. SODIUM MONOFLUOROPHOSPHATE .884 g/100g 61543-7254_0d7575a7-43a9-4703-b1ea-966373171d04 61543-7254 HUMAN OTC DRUG Plus White Plus EVERY DAY WHITENING SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20130801 OTC MONOGRAPH FINAL part355 CCA Industries, Inc. SODIUM MONOFLUOROPHOSPHATE 1.14 g/100g 61543-7501_62221ffb-8494-4cc0-9bbd-3c9e0bd09e93 61543-7501 HUMAN OTC DRUG HAND PERFECTION ANTI-AGING SKINCARE nourishing day SPF 15 ZINC OXIDE, OCTINOXATE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. OCTINOXATE; ZINC OXIDE 60; 20 mg/mL; mg/mL 61543-7595_c5333782-61bc-4d25-b38d-8fa1671748fa 61543-7595 HUMAN OTC DRUG SOLAR SENSE CLEAR ZINC SUNSCREEN FACE and LIPS BROAD SPECTRUM SPF 50 Plus OCTISALATE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 14.5 g/100g; g/100g; g/100g 61543-7753_b70aa8e0-5ca3-4eb3-af91-06f9baa65a47 61543-7753 HUMAN OTC DRUG SOLAR SENSE CLEAR ZINC SUNSCREEN FACE and BODY BROAD SPECTRUM SPF 70 OCTINOXATE, OCTOCRYLENE, ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 45; 80; 145 mg/mL; mg/mL; mg/mL 61543-7755_226992dc-39f4-4d94-9038-8f4db8bee99c 61543-7755 HUMAN OTC DRUG SOLAR SENSE CLEAR ZINC SUNSCREEN FACE and BODY SPORT BROAD SPECTRUM SPF 50 Plus OCTISALATE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 50; 145 mg/mL; mg/mL; mg/mL 61543-7770_0fc0df6d-f0d5-47ca-86e9-019ff4829228 61543-7770 HUMAN OTC DRUG Solar Sense Sun Damage Restoration Body SPF 15 ZINC OXIDE, OCTINOXATE LOTION TOPICAL 20101002 OTC MONOGRAPH FINAL part352 CCA Industries, Inc OCTINOXATE; ZINC OXIDE 6; 2 mL/100mL; mL/100mL 61543-7772_b5caae08-4724-49fd-a7dc-d188cbe137a2 61543-7772 HUMAN OTC DRUG Solar Sense Clear Zinc Body SPF 50 AVOBENZONE, OCTINOXATE, ZINC OXIDE, OCTOCRYLENE STICK TOPICAL 20101004 OTC MONOGRAPH FINAL part352 CCA Industries, Inc AVOBENZONE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 3; 7.5; 9; 8 g/100g; g/100g; g/100g; g/100g 61543-7774_6e7f47f6-98af-4db0-9a24-c0ed0858827c 61543-7774 HUMAN OTC DRUG Solar Sense Clear Zinc Sport Body SPF 50 AVOBENZONE, OCTINOXATE, ZINC OXIDE, OCTOCRYLENE STICK TOPICAL 20101005 OTC MONOGRAPH FINAL part352 CCA Industries, Inc AVOBENZONE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 3; 7.5; 9; 8 g/41g; g/100g; g/100g; g/100g 61543-7782_6a16c1c9-6514-403f-9a75-28cebfee19fa 61543-7782 HUMAN OTC DRUG Solar Sense Zany Zinc SPF 50 - Pink ZINC OXIDE CREAM TOPICAL 20101004 OTC MONOGRAPH FINAL part352 CCA Industries, Inc ZINC OXIDE 25 g/100g 61543-7783_7955e9ea-8dca-4835-9c7e-7ebfd1273cdd 61543-7783 HUMAN OTC DRUG SOLAR SENSE ZANY ZINC SPF 50 - GREEN ZINC OXIDE CREAM TOPICAL 20111222 OTC MONOGRAPH FINAL part352 CCA Industries, Inc. ZINC OXIDE 25 g/100g 61543-7784_f705efa4-5e08-4a7c-ba58-39858bb429db 61543-7784 HUMAN OTC DRUG Solar Sense Zany Zinc SPF 50 - Blue ZINC OXIDE CREAM TOPICAL 20101003 OTC MONOGRAPH FINAL part352 CCA Industries, Inc ZINC OXIDE 25 g/100g 61543-7785_8ad584dd-5e31-44cf-9b87-10228045e149 61543-7785 HUMAN OTC DRUG SOLAR SENSE ZANY ZINC SPF 50 - WHITE ZINC OXIDE CREAM TOPICAL 20111222 OTC MONOGRAPH FINAL part352 CCA Industries, Inc. ZINC OXIDE 25 g/100g 61543-7786_18d35757-ce63-47c4-9faf-d16e4d31b5f4 61543-7786 HUMAN OTC DRUG Solar Sense Zany Zinc SPF 50 - Yellow ZINC OXIDE CREAM TOPICAL 20101004 OTC MONOGRAPH FINAL part352 CCA Industries, Inc ZINC OXIDE 25 g/100g 61543-7788_5ee50c54-3ae1-469b-8f4b-756c6b234774 61543-7788 HUMAN OTC DRUG SOLAR SENSE CLEAR ZINC SUNSCREEN Baby Tear Free FACE AND BODY BROAD SPECTRUM SPF 50 OCTISALATE, OCTINOXATE, ZINC OXIDE STICK TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 14.5 g/100g; g/100g; g/100g 61543-7943_4e73b5d8-8ce2-4555-92c8-ab115ea10606 61543-7943 HUMAN OTC DRUG SOLAR SENSE CLEAR ZINC SUNSCREEN VALUE PACK 50 PLUS OCTISALATE, OCTINOXATE, ZINC OXIDE KIT 20130807 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. 61547-101_42750f45-adf0-4860-b20e-4f3bd9cdab77 61547-101 HUMAN OTC DRUG CALIFORNIA NATUREL LIP BALM SPF 8 TITANIUM DIOXIDE AND ZINC OXIDE LIPSTICK TOPICAL 20140114 OTC MONOGRAPH FINAL part352 CALIFORNIA NATUREL TITANIUM DIOXIDE; ZINC OXIDE 1.8; 2 g/100g; g/100g 61547-102_f8f1c901-a9a5-4cff-bb84-7aacd7221bdf 61547-102 HUMAN OTC DRUG CALIFORNIA NATUREL ALL NATURAL SUNSCREEN SPF 30 ZINC OXIDE LOTION TOPICAL 20140114 OTC MONOGRAPH FINAL part352 CALIFORNIA NATUREL ZINC OXIDE 20 g/100g 61551-0101_281d1187-b0e5-41ae-90a9-8334644d293c 61551-0101 HUMAN OTC DRUG GINSENG KIANPI PIL GINSENG KIANPI CAPSULE ORAL 20140107 UNAPPROVED HOMEOPATHIC Guangzhou HanWindBeauty Commerce Co.,Ltd ANGELICA SINENSIS WHOLE; MORINDA OFFICINALIS WHOLE; PANAX GINSENG ROOT OIL 20; 22; 28 mg/g; mg/g; mg/g 61558-100_2bd9fc8a-42c4-4461-bfef-d1aa2e26d2c9 61558-100 HUMAN OTC DRUG Eron Healing Tonic Zinc Pyrithione SHAMPOO TOPICAL 20131230 UNAPPROVED DRUG OTHER GS-TK Co., Ltd PANTHENOL; PYRITHIONE ZINC 2.5; 3 g/500mL; g/500mL 61561-012_359c78c1-08a6-48f6-a95c-68b894771d73 61561-012 HUMAN OTC DRUG Zims Advanced Cold Sore And Fever Blister Moisturizing Protectant With Purified Propolis Petrolatum KIT 20140115 OTC MONOGRAPH FINAL part347 Perfecta Products, Inc. 61570-024_eef51cdb-7214-4c23-8cfc-6ad41eca14ef 61570-024 HUMAN PRESCRIPTION DRUG THALITONE chlorthalidone TABLET ORAL 19881220 NDA NDA019574 Monarch Pharmaceuticals, Inc CHLORTHALIDONE 15 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 61570-031_150c7f10-c28d-41f3-a74a-6e478fa7862c 61570-031 HUMAN PRESCRIPTION DRUG CORTISPORIN neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone OINTMENT TOPICAL 19550415 NDA NDA050168 Pfizer Laboratories Div Pfizer Inc BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 10; 3.5; 5000 [iU]/g; mg/g; mg/g; [iU]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61570-032_de5eeca6-32f8-4735-b488-08c0cc33a690 61570-032 HUMAN PRESCRIPTION DRUG CORTISPORIN NEOMYCIN SULFATE, POLYMYXIN B SULFATE, and HYDROCORTISONE ACETATE CREAM TOPICAL 19630610 NDA NDA050218 Monarch Pharmaceuticals, Inc. HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 5; 3.5; 10000 mg/g; mg/g; [iU]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61570-034_2d34b926-ee19-496b-a292-2366aa912c91 61570-034 HUMAN PRESCRIPTION DRUG CORTISPORIN neomycin sulfate, polymyxin B sulfate and hydrocortisone SOLUTION AURICULAR (OTIC) 19751117 NDA NDA050479 Monarch Pharmaceuticals, Inc. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [iU]/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 61570-037_b4ad214b-3668-4db7-aee2-0890cf9d04f8 61570-037 HUMAN PRESCRIPTION DRUG VIROPTIC trifluridine SOLUTION OPHTHALMIC 19800410 NDA NDA018299 Pfizer Laboratories Div Pfizer Inc TRIFLURIDINE 1 g/100mL Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 61570-045_b8cd1d5a-9d3b-465e-9e5b-2f67af8dbeb2 61570-045 HUMAN PRESCRIPTION DRUG NEOSPORIN neomycin and polymyxin B sulfates and gramicidin SOLUTION OPHTHALMIC 19550411 ANDA ANDA060582 Monarch Pharmaceuticals, Inc. GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE .025; 1.75; 10000 mg/mL; mg/mL; [iU]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 61570-047_d519c951-96e3-4e7d-a4f2-10c784382190 61570-047 HUMAN PRESCRIPTION DRUG NEOSPORIN G.U. neomycin sulfate - polymyxin B sulfate SOLUTION IRRIGATION 19660628 ANDA ANDA060707 Pfizer Laboratories Div Pfizer Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE 40; 200000 mg/mL; [iU]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 61570-048_d519c951-96e3-4e7d-a4f2-10c784382190 61570-048 HUMAN PRESCRIPTION DRUG NEOSPORIN G.U. neomycin sulfate - polymyxin B sulfate SOLUTION IRRIGATION 19660628 ANDA ANDA060707 Pfizer Laboratories Div Pfizer Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE 40; 200000 mg/mL; [iU]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 61570-072_4bc91630-a815-40fc-98da-29747f253095 61570-072 HUMAN PRESCRIPTION DRUG MENEST esterified estrogens TABLET, FILM COATED ORAL 19770928 ANDA ANDA084951 Pfizer Laboratories Div Pfizer Inc ESTROGENS, ESTERIFIED .3 mg/1 61570-073_4bc91630-a815-40fc-98da-29747f253095 61570-073 HUMAN PRESCRIPTION DRUG MENEST esterified estrogens TABLET, FILM COATED ORAL 19770928 ANDA ANDA084948 Pfizer Laboratories Div Pfizer Inc ESTROGENS, ESTERIFIED .625 mg/1 61570-074_4bc91630-a815-40fc-98da-29747f253095 61570-074 HUMAN PRESCRIPTION DRUG MENEST esterified estrogens TABLET, FILM COATED ORAL 19770928 ANDA ANDA084950 Pfizer Laboratories Div Pfizer Inc ESTROGENS, ESTERIFIED 1.25 mg/1 61570-075_4bc91630-a815-40fc-98da-29747f253095 61570-075 HUMAN PRESCRIPTION DRUG MENEST esterified estrogens TABLET, FILM COATED ORAL 19770928 ANDA ANDA084949 Pfizer Laboratories Div Pfizer Inc ESTROGENS, ESTERIFIED 2.5 mg/1 61570-079_bc4c9007-945b-4f2c-a3de-9a2bebf8a8a2 61570-079 HUMAN PRESCRIPTION DRUG TIGAN trimethobenzamide hydrochloride CAPSULE ORAL 20011213 NDA NDA017531 Pfizer Laboratories Div Pfizer Inc TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 61570-081_152f3f38-dca7-48ff-8f06-3765a9a37564 61570-081 HUMAN PRESCRIPTION DRUG Tussigon hydrocodone bitartrate and homatropine methylbromide TABLET ORAL 19850730 ANDA ANDA088508 Pfizer Laboratories Div Pfizer Inc HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 61570-102_1248fd87-debd-484b-8da8-37ab64bce670 61570-102 HUMAN PRESCRIPTION DRUG Tussigon hydrocodone bitartrate and homatropine methylbromide TABLET ORAL 19850730 ANDA ANDA088508 Pfizer Laboratories Div Pfizer Inc HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 61570-110_25ec59a1-1a2b-4632-bd06-9a6b695f69fa 61570-110 HUMAN PRESCRIPTION DRUG ALTACE ramipril CAPSULE ORAL 19910128 NDA NDA019901 Pfizer Laboratories Div Pfizer Inc RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 61570-111_25ec59a1-1a2b-4632-bd06-9a6b695f69fa 61570-111 HUMAN PRESCRIPTION DRUG ALTACE ramipril CAPSULE ORAL 19910128 NDA NDA019901 Pfizer Laboratories Div Pfizer Inc RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 61570-112_25ec59a1-1a2b-4632-bd06-9a6b695f69fa 61570-112 HUMAN PRESCRIPTION DRUG ALTACE ramipril CAPSULE ORAL 19910128 NDA NDA019901 Pfizer Laboratories Div Pfizer Inc RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 61570-120_25ec59a1-1a2b-4632-bd06-9a6b695f69fa 61570-120 HUMAN PRESCRIPTION DRUG ALTACE ramipril CAPSULE ORAL 19910128 NDA NDA019901 Pfizer Laboratories Div Pfizer Inc RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 61570-131_aea2de53-ef53-486e-9494-f303cfaff3e2 61570-131 HUMAN PRESCRIPTION DRUG SILVADENE silver sulfadiazine CREAM TOPICAL 19731126 NDA NDA017381 Pfizer Laboratories Div Pfizer Inc SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 61570-260_993b9380-e18d-4b06-b487-b07cfe7008a4 61570-260 HUMAN PRESCRIPTION DRUG Synercid quinupristin and dalfopristin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19990921 NDA NDA050748 Pfizer Laboratories Div Pfizer Inc DALFOPRISTIN; QUINUPRISTIN 350; 150 mg/5mL; mg/5mL Streptogramin Antibacterial [EPC],Streptogramins [Chemical/Ingredient],Streptogramin Antibacterial [EPC],Streptogramins [Chemical/Ingredient] 61577-2280_2c0060ca-c788-4eab-84e3-2fc4b1e4f230 61577-2280 HUMAN OTC DRUG SORE NO MORE MENTHOL CAMPHOR GEL TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. CAMPHOR (SYNTHETIC); MENTHOL .03; .03 g/g; g/g 61577-2301_21b2f6cb-3727-4f34-880d-553d6ef8cf3a 61577-2301 HUMAN OTC DRUG MUSCLE EASE MENTHOL CAMPHOR GEL TOPICAL 20111216 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. CAMPHOR (SYNTHETIC); MENTHOL .03; .03 g/g; g/g 61577-3216_22e4f981-505f-4e03-9c85-c9dc3db2fb20 61577-3216 HUMAN OTC DRUG SOMBRA WARM THERAPY MENTHOL CAMPHOR GEL TOPICAL 20111216 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. CAMPHOR (SYNTHETIC); MENTHOL .03; .03 g/g; g/g 61577-3221_4dbd52a2-af4b-4a3f-bd33-703db021dc11 61577-3221 HUMAN OTC DRUG SOMBRA COOL THERAPY MENTHOL GEL TOPICAL 20111216 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. MENTHOL .06 g/g 61577-3610_1fb514f2-a819-4350-94c5-d1606b4bbe5f 61577-3610 HUMAN OTC DRUG DEEP REMEDY MENTHOL CAMPHOR GEL TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. CAMPHOR (SYNTHETIC); MENTHOL .03; .03 g/g; g/g 61577-3710_81b81277-b098-46ec-8201-a8b7bd8eb0a0 61577-3710 HUMAN OTC DRUG THERAID MENTHOL GEL TOPICAL 20130220 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. MENTHOL .04 g/g 61578-203_44cbd3db-47a6-4030-a1c0-851a8494516b 61578-203 HUMAN OTC DRUG CTx4 Gel 1100 Mint sodium fluoride GEL, DENTIFRICE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Oral BioTech SODIUM FLUORIDE 1100 ug/g 61578-204_44cbd3db-47a6-4030-a1c0-851a8494516b 61578-204 HUMAN OTC DRUG CTx4 Gel 1100 Citrus sodium fluoride GEL, DENTIFRICE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Oral BioTech SODIUM FLUORIDE 1100 ug/g 61578-205_08101317-6b6b-4243-8e77-19f151f4b856 61578-205 HUMAN PRESCRIPTION DRUG CTx4 Gel 5000 Mint Sodium fluoride GEL, DENTIFRICE DENTAL 20120501 UNAPPROVED DRUG OTHER Oral BioTech SODIUM FLUORIDE 5000 ug/g 61578-206_08101317-6b6b-4243-8e77-19f151f4b856 61578-206 HUMAN PRESCRIPTION DRUG CTx4 Gel 5000 Citrus Sodium fluoride GEL, DENTIFRICE DENTAL 20120501 UNAPPROVED DRUG OTHER Oral BioTech SODIUM FLUORIDE 5000 ug/g 61578-207_44cbd3db-47a6-4030-a1c0-851a8494516b 61578-207 HUMAN OTC DRUG CTx4 Gel 1100 Grape sodium fluoride GEL, DENTIFRICE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Oral BioTech SODIUM FLUORIDE 1100 ug/g 61578-301_16ba2e79-b217-44b5-b228-76507e06eb12 61578-301 HUMAN OTC DRUG CTx3 Rinse Mint Anticaries RINSE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Oral BioTech SODIUM FLUORIDE 226 ug/mL 61578-302_16ba2e79-b217-44b5-b228-76507e06eb12 61578-302 HUMAN OTC DRUG CTx3 Rinse Citrus Anticaries RINSE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Oral BioTech SODIUM FLUORIDE 226 ug/mL 61578-303_16ba2e79-b217-44b5-b228-76507e06eb12 61578-303 HUMAN OTC DRUG CTx3 Rinse Grape Anticaries RINSE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Oral BioTech SODIUM FLUORIDE 226 ug/mL 61578-304_cbfdbbf7-06fb-418f-8e5e-35847dfb3e5c 61578-304 HUMAN OTC DRUG CTx4 Rinse Mint Anticaries RINSE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Oral BioTech SODIUM FLUORIDE 226 ug/mL 61578-305_cbfdbbf7-06fb-418f-8e5e-35847dfb3e5c 61578-305 HUMAN OTC DRUG CTx4 Rinse Apple Anticaries RINSE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Oral BioTech SODIUM FLUORIDE 226 ug/mL 61579-001_1f813477-467e-4d05-a213-9db4e0227b71 61579-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140102 UNAPPROVED MEDICAL GAS Advantage Home Medical LLC OXYGEN 99 L/100L 61582-532_2490071e-a4b1-4dd3-9087-95390f5f3832 61582-532 HUMAN OTC DRUG Natures Sunshine Products Everflex Topical Analgesic Pain Relief Menthol CREAM TOPICAL 20100813 OTC MONOGRAPH NOT FINAL part348 Natures Sunshine Products, Inc. MENTHOL 1.25 g/100g 61587-1001_0cf10c77-4e5e-49fd-8234-3d8d7aca5144 61587-1001 HUMAN OTC DRUG Hwang Geum-San Gold Hair GLYCERIN SHAMPOO TOPICAL 20140114 OTC MONOGRAPH FINAL part347 Hwang Geum-San Co., Ltd GLYCERIN .2 g/100mL 61589-0011_e6ee3bb6-3b6d-448c-9187-eb6c183b2162 61589-0011 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Mocha No. 64 OCTINOXATE CREAM TOPICAL 20141217 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 70 mg/mL 61589-1812_b5300a64-7d13-42dd-bbea-ddc2341f8169 61589-1812 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 New Ivory 10 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-1814_332fecb0-3324-4f4a-9cd7-e2e68efc1e75 61589-1814 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Blonde 20 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-1815_a7dd249a-39b3-454c-958e-5894d49eab1b 61589-1815 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Vanilla 25 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-1816_27246973-b990-421d-8807-dfed6faa4191 61589-1816 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Almond 30 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-1818_cb5f2d61-7589-4161-9db3-409e6d92ec00 61589-1818 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Truffle 50 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-1821_f902e754-2994-4826-b545-b2bb744de2ad 61589-1821 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 05 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-1822_0ba8684b-529b-4e2d-a0aa-16c6d665dd6f 61589-1822 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Buff 15 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-1823_ad3656f8-bcb4-4423-8278-0a984b464a38 61589-1823 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Suede 40 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-1824_13ff2832-4e25-472c-89a6-c30e5548e7a5 61589-1824 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Espresso 45 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-1825_c5cb4bdb-a6d2-4d09-9171-90b19a9588f7 61589-1825 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Tan 35 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-1826_6b230cd9-f67f-4687-9003-3a72012f9425 61589-1826 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Cocoa 55 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-1827_a9599c2c-34fa-40f9-ac33-35eac58e2f3b 61589-1827 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Mocha 60 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-1904_c690ab88-f687-4d83-a2b4-39b493a2ba25 61589-1904 HUMAN OTC DRUG No7 Soft and Sheer Tinted Moisturiser Fair Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100305 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 2.5; .95 mL/50mL; mL/50mL 61589-1905_4939ae99-6e9f-4b63-adc6-2bec3a92151b 61589-1905 HUMAN OTC DRUG No7 Soft and Sheer Tinted Moisturiser Medium Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100305 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 2.5; .95 mL/50mL; mL/50mL 61589-1906_5a503b63-1188-4db9-9048-b4db76afef21 61589-1906 HUMAN OTC DRUG No7 Soft and Sheer Tinted Moisturiser Dark Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100305 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 2.5; .95 mL/50mL; mL/50mL 61589-1911_8e7da61d-980e-4ce5-8045-63042d082f3b 61589-1911 HUMAN OTC DRUG No7 Dual Action Tinted Moisturiser Fair Avobenzone, Octisalate and Octocrylene EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g 61589-1913_1bde3af8-7033-409c-ac45-9fe483edbb60 61589-1913 HUMAN OTC DRUG No7 Dual Action Tinted Moisturiser Medium Avobenzone, Octisalate and Octocrylene EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g 61589-3809_036c560a-afd1-4359-abad-31360e3e3567 61589-3809 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Porcelain 05 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-3810_b88dba89-ab5a-4b34-bf1c-0e67dfd89db3 61589-3810 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 New Ivory 10 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-3811_6b21248a-a6cb-479c-95a9-298064adc0ea 61589-3811 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Nude 15 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-3812_da8c195b-1c14-470a-b8b4-fdece2c4ba85 61589-3812 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Blonde 20 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100111 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-3813_31eae540-a8e7-4d6a-b0d3-7210de3e1260 61589-3813 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Vanilla 25 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-3814_0168867a-226f-49c2-9656-3b27ae331ef6 61589-3814 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Almond 35 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100111 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-3815_c65a35f1-a552-4e51-aa18-ef6d6c801e7b 61589-3815 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Walnut 45 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-3816_617cd224-404e-45a6-ab6d-7d5b8a99da2d 61589-3816 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Truffle 50 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 61589-5311_04b12455-a1b4-42e0-be9a-60f60c9d069c 61589-5311 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Ebony OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g 61589-5312_4045d682-5c6f-4a5d-be6b-2393e9465f07 61589-5312 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Cool Beige OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g 61589-5313_f5e6e012-6ebb-4ef2-a3f5-eb8402b71ace 61589-5313 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Calico OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g 61589-5314_07d79035-b32d-4598-bfa2-4a0344a34b20 61589-5314 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Mocha OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g 61589-5315_90770e5a-a0f9-4df9-b094-d01ce590bdd8 61589-5315 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Honey OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g 61589-5316_b9dbab00-7637-4aac-82e6-d9a7dc2541ba 61589-5316 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Wheat OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g 61589-5317_23d2636f-4eb1-4390-87ac-a35cb793f644 61589-5317 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g 61589-5318_afb9d54b-d5c2-4be7-bd14-29183d3a81c6 61589-5318 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g 61589-5319_2a5c0dbf-06ee-4d3f-813c-6734af8fa130 61589-5319 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g 61589-6001_ce0bff73-2eba-42b3-9ac7-d56b6851a498 61589-6001 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Ebony Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 2.25 g/30g 61589-6002_81312aef-014f-4987-a95b-fbef246e81db 61589-6002 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Mocha Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 2.25 g/30g 61589-6003_9ee7afa4-a1bb-450a-8482-8397776b611c 61589-6003 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Wheat Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 2.25 g/30g 61589-6004_50a08ba8-60c2-4260-83c1-c1959599a758 61589-6004 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 2.25 g/30g 61589-6005_6e3ef9b9-a7ae-4f61-9150-57afefc65216 61589-6005 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Cool Beige Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 2.25 g/30g 61589-6006_a7527907-4d3d-43f8-90dc-b9e1c1b6b10c 61589-6006 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 2.25 g/30g 61589-6007_a24b0a1b-5389-487e-8336-eeea62744fe2 61589-6007 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 2.25 g/30g 61589-6008_a8ed0087-da06-4694-9299-a6e61ad14741 61589-6008 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Calico Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 2.25 g/30g 61589-6009_8a881a35-0fd3-4f32-97c1-2d4a308c7e6e 61589-6009 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Deeply Honey Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g 61589-6010_bcc5ea07-9a1b-4bfc-878f-22d83063fda4 61589-6010 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Honey Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g 61589-6011_30b754aa-7c12-4eae-a33b-6528d249451e 61589-6011 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Warm Beige Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g 61589-6012_808d16dd-5a11-43e0-82c3-305a4016e18e 61589-6012 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Chestnut Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g 61589-6013_4e608985-150d-4a8f-a6d6-a63352e1bf08 61589-6013 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Hazelnut Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g 61589-6014_37d761da-b067-44f3-8bfa-0e501714d3f8 61589-6014 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Warm Sand Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g 61589-6015_e969bbf3-0665-4a43-8996-fe871363838e 61589-6015 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Warm Ivory Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g 61589-6016_16014b26-8d42-4417-a6df-66cb4305b6de 61589-6016 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Toffee Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g 61589-6017_b36cef6d-26b7-40a7-a96b-f744623c7381 61589-6017 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Cool Honey Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g 61589-6018_a402b7a7-09cb-4571-a19a-e44650ea2038 61589-6018 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Latte Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g 61589-6502_ecf9e85d-9a69-4adb-a57f-494b380f306a 61589-6502 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Mocha Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g 61589-6503_3f0fd100-d3b7-4760-846e-d4e46fd9b584 61589-6503 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Wheat Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g 61589-6504_ef96b4f3-d413-4680-8bce-4ed515ce4c83 61589-6504 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g 61589-6505_eda7db2c-c4c5-4f32-8ba3-7320c4fb6883 61589-6505 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Beige Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g 61589-6506_55f1c013-3cb2-4ed6-a39d-e63392126056 61589-6506 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g 61589-6507_17424102-088d-4e8a-b3a9-4debacec1c9f 61589-6507 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g 61594-000_ba10d804-11bd-4e40-b5b4-869b68acd98b 61594-000 HUMAN OTC DRUG Theraworx pre-moistened cloths ALLANTOIN LIQUID TOPICAL 20140313 OTC MONOGRAPH FINAL part347 Avadim Technologies, Inc. ALLANTOIN .5 g/100g 61594-001_6d9b3b30-342d-4ad1-aa1c-b11431be86e5 61594-001 HUMAN OTC DRUG Theraworx Patented Foam Formulation ALLANTOIN LIQUID TOPICAL 20140109 OTC MONOGRAPH FINAL part347 Avadim Technologies, Inc. ALLANTOIN 5 mg/mL 61598-200_85a3bbaf-f55a-4c7a-aac8-07e9572f393e 61598-200 HUMAN OTC DRUG VeraSeptine Multipurpose Moisture Barrier Zinc Oxide CREAM TOPICAL 20131007 OTC MONOGRAPH FINAL part347 LTC Products, Inc. ZINC OXIDE 21 g/100g 61601-0079_0b9892bb-a399-4596-8598-3a847ff185d1 61601-0079 HUMAN OTC DRUG LIPSTICK QUEEN ENDLESS SUMMER Broad Spectrum SPF 15 Sunscreen Homosalate, Octinoxate, Avobenzone and Octocrylene LIPSTICK TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE .105; .35; .14; .07 g/3.5g; g/3.5g; g/3.5g; g/3.5g 61601-0080_0b9892bb-a399-4596-8598-3a847ff185d1 61601-0080 HUMAN OTC DRUG LIPSTICK QUEEN ENDLESS SUMMER Broad Spectrum SPF 15 Sunscreen Homosalate, Octinoxate, Avobenzone and Octocrylene LIPSTICK TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE .105; .35; .14; .07 g/3.5g; g/3.5g; g/3.5g; g/3.5g 61601-0081_0b9892bb-a399-4596-8598-3a847ff185d1 61601-0081 HUMAN OTC DRUG LIPSTICK QUEEN ENDLESS SUMMER Broad Spectrum SPF 15 Sunscreen Homosalate, Octinoxate, Avobenzone and Octocrylene LIPSTICK TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE .105; .35; .14; .07 g/3.5g; g/3.5g; g/3.5g; g/3.5g 61601-0082_0b9892bb-a399-4596-8598-3a847ff185d1 61601-0082 HUMAN OTC DRUG LIPSTICK QUEEN ENDLESS SUMMER Broad Spectrum SPF 15 Sunscreen Homosalate, Octinoxate, Avobenzone and Octocrylene LIPSTICK TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE .105; .35; .14; .07 g/3.5g; g/3.5g; g/3.5g; g/3.5g 61601-1112_80586845-def2-462f-928d-21eead404fdf 61601-1112 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 2.5; 3.1 g/50mL; g/50mL 61601-1113_80586845-def2-462f-928d-21eead404fdf 61601-1113 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 2.5; 3.1 g/50mL; g/50mL 61601-1114_80586845-def2-462f-928d-21eead404fdf 61601-1114 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 2.5; 3.1 g/50mL; g/50mL 61601-1115_80586845-def2-462f-928d-21eead404fdf 61601-1115 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 2.5; 3.1 g/50mL; g/50mL 61601-1116_80586845-def2-462f-928d-21eead404fdf 61601-1116 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 2.5; 3.1 g/50mL; g/50mL 61601-1117_80586845-def2-462f-928d-21eead404fdf 61601-1117 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 2.5; 3.1 g/50mL; g/50mL 61601-1118_80586845-def2-462f-928d-21eead404fdf 61601-1118 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 2.5; 3.1 g/50mL; g/50mL 61601-1119_80586845-def2-462f-928d-21eead404fdf 61601-1119 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 2.5; 3.1 g/50mL; g/50mL 61601-1120_80586845-def2-462f-928d-21eead404fdf 61601-1120 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 2.5; 3.1 g/50mL; g/50mL 61601-1121_80586845-def2-462f-928d-21eead404fdf 61601-1121 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 2.5; 3.1 g/50mL; g/50mL 61601-1122_80586845-def2-462f-928d-21eead404fdf 61601-1122 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 2.5; 3.1 g/50mL; g/50mL 61601-1123_80586845-def2-462f-928d-21eead404fdf 61601-1123 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 2.5; 3.1 g/50mL; g/50mL 61601-1124_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1124 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1125_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1125 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1126_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1126 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1127_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1127 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1128_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1128 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1129_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1129 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1130_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1130 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1131_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1131 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1132_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1132 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1133_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1133 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1134_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1134 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1135_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1135 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1136_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1136 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1137_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1137 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1138_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1138 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1139_0799bfca-4ae5-4bc5-a12c-da0d392c25bf 61601-1139 HUMAN OTC DRUG Eve Lom Brilliant Cover Concealer Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE .078; .08 g/2g; g/2g 61601-1140_0799bfca-4ae5-4bc5-a12c-da0d392c25bf 61601-1140 HUMAN OTC DRUG Eve Lom Brilliant Cover Concealer Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE .078; .08 g/2g; g/2g 61601-1141_0799bfca-4ae5-4bc5-a12c-da0d392c25bf 61601-1141 HUMAN OTC DRUG Eve Lom Brilliant Cover Concealer Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE .078; .08 g/2g; g/2g 61601-1142_0799bfca-4ae5-4bc5-a12c-da0d392c25bf 61601-1142 HUMAN OTC DRUG Eve Lom Brilliant Cover Concealer Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE .078; .08 g/2g; g/2g 61601-1143_0799bfca-4ae5-4bc5-a12c-da0d392c25bf 61601-1143 HUMAN OTC DRUG Eve Lom Brilliant Cover Concealer Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE .078; .08 g/2g; g/2g 61601-1144_0799bfca-4ae5-4bc5-a12c-da0d392c25bf 61601-1144 HUMAN OTC DRUG Eve Lom Brilliant Cover Concealer Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE .078; .08 g/2g; g/2g 61601-1175_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1175 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1176_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1176 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1177_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1177 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1181_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1181 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1182_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1182 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1183_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1183 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.38 g/30mL; g/30mL 61601-1193_0bd5c5a1-06bc-4318-a363-3a1fc6cf980b 61601-1193 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 2.5; 3.1 g/50mL; g/50mL 61601-1194_0bd5c5a1-06bc-4318-a363-3a1fc6cf980b 61601-1194 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 2.5; 3.1 g/50mL; g/50mL 61601-1195_0bd5c5a1-06bc-4318-a363-3a1fc6cf980b 61601-1195 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 2.5; 3.1 g/50mL; g/50mL 61601-1196_0bd5c5a1-06bc-4318-a363-3a1fc6cf980b 61601-1196 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; TITANIUM DIOXIDE 2.5; 3.1 g/50mL; g/50mL 61601-1217_a8421133-f2e7-42d2-add8-fd5d3ab03d90 61601-1217 HUMAN OTC DRUG Eve Lom Daily Protection Broad Spectrum SPF 50 Sunscreen Homosalate, Octisalate, Oxybenzone, Avobenzone, Octinoxate and Octocrylene CREAM TOPICAL 20140602 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .15; .5; .15; .25; .135; .25 g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL 61601-1233_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1233 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .55; .55; .35; .52 g/10g; g/10g; g/10g; g/10g 61601-1234_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1234 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .55; .55; .35; .52 g/10g; g/10g; g/10g; g/10g 61601-1235_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1235 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .55; .55; .35; .52 g/10g; g/10g; g/10g; g/10g 61601-1236_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1236 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .55; .55; .35; .52 g/10g; g/10g; g/10g; g/10g 61601-1237_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1237 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .55; .55; .35; .52 g/10g; g/10g; g/10g; g/10g 61601-1238_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1238 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .55; .55; .35; .52 g/10g; g/10g; g/10g; g/10g 61601-1239_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1239 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .55; .55; .35; .52 g/10g; g/10g; g/10g; g/10g 61601-1240_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1240 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .55; .55; .35; .52 g/10g; g/10g; g/10g; g/10g 61601-1241_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1241 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .55; .55; .35; .52 g/10g; g/10g; g/10g; g/10g 61601-1242_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1242 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .55; .55; .35; .52 g/10g; g/10g; g/10g; g/10g 61601-1243_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1243 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .55; .55; .35; .52 g/10g; g/10g; g/10g; g/10g 61601-1244_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1244 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .55; .55; .35; .52 g/10g; g/10g; g/10g; g/10g 61601-1250_ea3bb52a-c7c8-4a26-836c-8c23baf318c6 61601-1250 HUMAN OTC DRUG Eve Lom Flawless Radiance Primer Broad Spectrum SPF 30 Sunscreen Octinoxate, Octisalate, Octocrylene, Oxybenzone and Avobenzone LOTION TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.35; 3.35; 2.25; 2.25; 1.5 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL 61604-9068_be715779-3f0b-42c3-a9d1-033763be1c14 61604-9068 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19930101 UNAPPROVED MEDICAL GAS Premier Medical Corporation OXYGEN 99 L/100L 61611-107_931eb823-d3a6-4e19-a77a-033472467541 61611-107 HUMAN OTC DRUG SUB-ZERO COOL PAIN RELIEVING MENTHOL GEL TOPICAL 20131229 OTC MONOGRAPH NOT FINAL part348 CURRENT SOLUTIONS LLC MENTHOL 3.9 g/100mL 61616-010_c833fe61-b2e4-4839-accb-d87406287edf 61616-010 HUMAN OTC DRUG Four Season PYRITHIONE ZINC SHAMPOO TOPICAL 20131201 OTC MONOGRAPH FINAL part358H OneLineSun Co., Ltd. PYRITHIONE ZINC 1.8 mg/300mL 61616-020_6245b26c-02a7-44b7-af56-985fd2805e53 61616-020 HUMAN OTC DRUG Four Season Essence Salicylic acid LIQUID TOPICAL 20131201 OTC MONOGRAPH FINAL part358H OneLineSun Co., Ltd. SALICYLIC ACID 2.16 mg/120mL 61619-717_63e89be2-c7f2-43bb-bfc6-58636e9cc0a8 61619-717 HUMAN OTC DRUG Antisepation Antimicrobial Cleansing Gel Benzethonium Chloride GEL CUTANEOUS 20140313 OTC MONOGRAPH NOT FINAL part333E A-Cute Derm, Incorporated BENZETHONIUM CHLORIDE 2 mg/mL 61619-864_d213a0f2-6eec-4ad0-b531-4e5b2e9f9be2 61619-864 HUMAN OTC DRUG Pro-Tect SPF 20 Broad-Spectrum UVA/UVB Sunscreen Meradimate, Octinoxate, Octisalate, Oxybenzone LOTION CUTANEOUS 19871201 OTC MONOGRAPH NOT FINAL part352 A-Cute Derm, Incorporated MERADIMATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL 61619-866_4afbc675-5771-4c55-ae08-11373761b348 61619-866 HUMAN OTC DRUG Pro-Tect SPF 30 Plus Broad-Spectrum UVA/UVB Sunscreen Meradimate, Octinoxate, Octisalate, Oxybenzone LOTION CUTANEOUS 19801101 OTC MONOGRAPH NOT FINAL part352 A-Cute Derm, Incorporated MERADIMATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL 61625-682_d0ada552-23e6-40be-b70a-9732a5922103 61625-682 HUMAN OTC DRUG Piranha Brand Alcohol Free Foaming Instant Hand Sanitizer with Aloe and Vitamin E Foaming Instant Hand Sanitizer with Aloe and Vitamin E SOLUTION TOPICAL 20130517 OTC MONOGRAPH NOT FINAL part333A Bio Shine, Inc. BENZETHONIUM CHLORIDE 7.56 g/100mL 61625-688_bb8f9d5a-e53f-40f4-baa3-d854bf6d0477 61625-688 HUMAN OTC DRUG Piranha Brand Foaming Alcohol Hand Sanitizer Foaming Hand Sanitizer SOLUTION TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part333A Bio Shine, Inc. ALCOHOL 62 mL/100mL 61625-689_b4658d6f-09ab-4b75-9bb3-df10391d940d 61625-689 HUMAN OTC DRUG Piranha Brand Foaming Antibacterial Hand Foaming Antibacterial Hand Soap with Aloe and Vitamin E SOLUTION TOPICAL 20130923 OTC MONOGRAPH NOT FINAL part333A Bio Shine, Inc. TRICLOSAN 18.9 g/100mL 61649-001_28ba9a37-1680-4d40-b162-06597120cc6c 61649-001 HUMAN OTC DRUG ATTITUDE Mineral sunscreen ZINC OXIDE CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bio Spectra ZINC OXIDE 20 g/100g 61657-0001_c5f1da5a-0181-4772-88b1-97b8b483f4c4 61657-0001 HUMAN OTC DRUG Addasect ARSENIC TRIOXIDE,RED CLOVER,PHYTOLACCA AMERICANA ROOT LIQUID ORAL 20111001 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro West ARSENIC TRIOXIDE; CHELIDONIUM MAJUS; LIQUID PETROLEUM; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; NITRIC ACID; PETROSELINUM CRISPUM; PEUMUS BOLDUS LEAF; PHOSPHORIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; STRYCHNOS NUX-VOMICA SEED; TARAXACUM PALUSTRE ROOT; TRIFOLIUM PRATENSE FLOWER 12; 13; 12; 12; 12; 12; 3; 3; 12; 12; 6; 12; 3; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0003_bfeda335-706e-4f99-a0f5-46d93c6c9898 61657-0003 HUMAN OTC DRUG Allerhale ARS ALB, PHOS,NUX VOM, PULS, SULPH, EUP, SOL, ECHI, BAPT LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro West ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; GARLIC; ONION; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 3; 3; 12; 3; 12; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0006_3f58b116-d262-46a9-a6d2-09422574fcc0 61657-0006 HUMAN OTC DRUG Anxiolix ARSENICUM ALBUM ,SCUTELLARIA LATERIFLORA,PHOSPHORUS,LACHESIS MUTUS,PULSATILLA,PASSIFLORA INCARNATA,ACONITE,VALERIANA OFFICINALIS,CALCAREA CARBONICA,IGNATIA AMARA LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro West ACONITUM NAPELLUS; ARSENIC TRIOXIDE; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; STRYCHNOS IGNATII SEED; VALERIAN 12; 12; 15; 12; 3; 12; 12; 3; 12; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0015_9c0e5897-aa23-4546-8c3c-1f33896bca09 61657-0015 HUMAN OTC DRUG A-D-D (Attention Span) A-D-D LIQUID ORAL 20110801 UNAPPROVED HOMEOPATHIC White Manufacturing Incorporated DBA Micro-West BARIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; THUJA OCCIDENTALIS LEAF 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0052_89c1c4b5-7c64-400f-b291-a4ec93ecbab0 61657-0052 HUMAN OTC DRUG BACTOFLAM ECHINACEA,BAPTISIA,APIS MELLIFICA ,FERRUM PHOSPHORICUM , LIQUID ORAL 20110610 UNAPPROVED HOMEOPATHIC WHITE MANUFACTURING INC. DBA MICRO WEST APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; FERRUM PHOSPHORICUM; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 3; 3; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0101_ee5a7ba8-57ad-40ca-b840-463f00499232 61657-0101 HUMAN OTC DRUG CAND-EX LYCOPODIUM,NUX VOMICA,BORAX,ASAFOETIDA,NUX MOSCHATA,GENTIANA LUTEA,KREOSOTUM,CALCAREA CARBONICA,SEPIA,PHOSPHORIC ACID,ECHINACEA,PULSATILLA,BAPTISIA, LIQUID ORAL 19930801 UNAPPROVED HOMEOPATHIC WHITE MANUFACTURING INC. DBA MICRO WEST ASAFETIDA; BAPTISIA TINCTORIA; ECHINACEA, UNSPECIFIED; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; NUTMEG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM BORATE; STRYCHNOS NUX-VOMICA SEED; WOOD CREOSOTE 12; 3; 3; 3; 30; 12; 12; 12; 30; 30; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0104_947eab07-c68f-477e-b4e0-d42eb2cdb72f 61657-0104 HUMAN OTC DRUG CHRON SINO ARSENICUM ALBUM,MAGNESIA PHOSPHORICA,PULSATILLA,RHUS TOXICODENDRON,BAPTISIA,PHYTOLACCA,HYDRASTIS,SEPIA,ECHINACEA,MERCURIUS SOLUBILIS,KALI BICHROMICUM, LIQUID ORAL 20040105 UNAPPROVED HOMEOPATHIC WHITE MANUFACTURING INC. DBA MICRO WEST ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; TOXICODENDRON PUBESCENS LEAF 12; 3; 3; 3; 12; 12; 3; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0154_dae2150b-341a-4904-828e-31ac62e2cbda 61657-0154 HUMAN OTC DRUG DPT TOX HYPERICUM,ECHINACEA,MEZEREUM,DROSERA,THUJA,KALI MURIATICUM,,SILICA, LIQUID ORAL 19940110 UNAPPROVED HOMEOPATHIC WHITE MANUFACTURING INC. DBA MICRO WEST DAPHNE MEZEREUM BARK; DROSERA ROTUNDIFOLIA; ECHINACEA, UNSPECIFIED; POTASSIUM CHLORIDE; SILICON DIOXIDE; ST. JOHN'S WORT; THUJA PLICATA LEAF 30; 12; 12; 12; 12; 12; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0157_dd4fb206-a166-441f-a0c2-1afdec79265f 61657-0157 HUMAN OTC DRUG Drainage D-Tox Lymph CALCAREA SCROPHULARIA NODOSA,SULPHUR IODATUM ,SOLIDAGO VIRGAUREA,PULSATILLA,RICINUS COMMUNIS,KALI MURIATICUM,PHYTOLACCA DECANDRA,MERCURIUS VIVUS,IODATA,KALI IODATUM,BELLADONNA,HEPAR SULPHURIS CALCAREUM,ECHINACEA PURPUREA, LIQUID ORAL 19971005 UNAPPROVED HOMEOPATHIC White Manufacturing DBA Micro-West ATROPA BELLADONNA; CALCIUM IODIDE; CALCIUM SULFIDE; ECHINACEA PURPUREA; MERCURY; PHYTOLACCA AMERICANA ROOT; POTASSIUM CHLORIDE; POTASSIUM IODIDE; PULSATILLA VULGARIS; RICINUS COMMUNIS SEED; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR IODIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0208_02680564-d7d4-48c6-b49b-923c45438c0d 61657-0208 HUMAN OTC DRUG Whole System EEP MERCURIUS CORROSIVUS,NUX VOMICA,HYOSCYAMINUM,CARCINOSINUM,GRAPHITES,ZINCUM METALLICUM,LILIUM TIGRINUM,CINCHONA OFFICINALIS,CAUSTICUM,COFFEA CRUDA,BELLADONNA,IGNATIA AMARA,SCROPHULARIA NODOSA,SPONGIA TOSTA ,CEANOTHUS AMERICANUS,SENNA,HYDRASTIS CANADENSIS,CONDURANGO,CHELIDONIUM MAJUS,PITUITARY GLAND, BOS TAURUS,PANCREAS SUIS,LYCOPODIUM CLAVATUM,BERBERIS VULGARIS, LIQUID ORAL 20050521 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West ARABICA COFFEE BEAN; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; BOS TAURUS PITUITARY GLAND; CAUSTICUM; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; GOLDENSEAL; GRAPHITE; HUMAN BREAST TUMOR CELL; HYOSCYAMINE; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; MARSDENIA CONDURANGO BARK; MERCURIC CHLORIDE; SCROPHULARIA NODOSA; SENNA LEAF; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; ZINC 1; 1; 12; 12; 5; 6; 3; 5; 3; 2; 10; 10; 5; 12; 3; 12; 15; 3; 6; 200; 10; 12; 3 [hp_M]/30mL; [hp_M]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_M]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_M]/30mL; [hp_X]/30mL; [hp_M]/30mL; [hp_M]/30mL; [hp_M]/30mL; [hp_M]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_M]/30mL; [hp_X]/30mL; [hp_M]/30mL 61657-0251_c5432ff5-facd-4b7f-b303-a1f5bb81fbca 61657-0251 HUMAN OTC DRUG Flualgia GELSEMIUM,ECHINACEA,BAPTISIA PHYTOLACCA DECANDRA,TINCTORIA,ARSENICUM ALBUM,IRIDIUM,MERCURIUS CORROSIVUS,EUPATORIUM PERFOLIATUM,BRYONIA,FERRUM PHOSPHORICUM, LIQUID ORAL 19920831 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; IRIDIUM; MERCURIC CHLORIDE; PHYTOLACCA AMERICANA ROOT 12; 3; 12; 3; 12; 12; 12; 12; 12; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0327_45c426f8-e07a-4cb4-832a-656ad0d98c78 61657-0327 HUMAN OTC DRUG HPZ HYPERICUM,NAT MUR,RAN B,THUJA,NITRIC ACID,RHUS TOX,GELSENICUM,ECHINACEA,LYCOPODUM,HYDRASTIS LIQUID ORAL 20110830 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West ECHINACEA PURPUREA; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; SODIUM CHLORIDE; ST. JOHN'S WORT; THUJA OCCIDENTALIS LEAF; TOXICODENDRON PUBESCENS LEAF 3; 12; 3; 12; 12; 12; 3; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0377_c2b575c2-8756-410f-9bba-9e346a21d673 61657-0377 HUMAN OTC DRUG Immuno Bac PHOSPHORUS,ARSENIC TRIOXIDE,LACHESIS MUTA VENOM,PHYTOLACCA AMERICANA ROOT,BAPTISIA TINCTORIA,ECHINACEA,, LIQUID ORAL 20110830 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA; ECHINACEA, UNSPECIFIED; FERRIC PHOSPHATE; GOLDENSEAL; LACHESIS MUTA VENOM; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; RANCID BEEF 12; 12; 3; 3; 12; 3; 15; 12; 12; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0526_ad208744-0dc8-47b8-83a1-cdd6330bcea5 61657-0526 HUMAN OTC DRUG Met-Tox Arsenicum Album, Avena Sativa,Lycopodium Clavatum,Natrum Muriaticum,Nux Vomica,Phytolacca DecandraRhamnus Frangula,Solidago Virgaurea,Trifolium Pratense,Heavy Metal Nosodes LIQUID ORAL 20060124 UNAPPROVED HOMEOPATHIC wHITE mANUFACTURING INC DBA MICRO-WEST ACTIVATED CHARCOAL; ALUMINUM; ANTIMONY; ARSENIC; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BARIUM; BERBERIS VULGARIS ROOT BARK; BERYLLIUM; BORON; BROMINE; CADMIUM; CALCIUM; CERIUM; CESIUM; CHLORIDE ION; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; FLUORIDE ION; FRANGULA ALNUS BARK; GADOLINIUM; GALLIUM; GOLD; HAFNIUM; HOLMIUM; HYDROGEN; INDIUM; IODINE; IRIDIUM; IRON; LEAD; LITHIUM; LUTETIUM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM; MERCURY; MOLYBDENUM; NEODYMIUM; NIOBIUM; NITROGEN; OSMIUM; PALLADIUM; PHYTOLACCA AMERICANA ROOT; PLATINUM; POTASSIUM; PRASEODYMIUM; RHODIUM; RUBIDIUM; RUTHENIUM; SAMARIUM; SCANDIUM; SELENIUM; SILICON; SILVER; SODIUM; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRONTIUM; STRYCHNOS NUX-VOMICA SEED; SULFUR; TANTALUM; TELLURIUM; TERBIUM; THORIUM; TIN; TITANIUM; TRIFOLIUM PRATENSE FLOWER; VANADIUM; YTTERBIUM; YTTRIUM; ZINC; ZIRCONIUM 12; 12; 12; 12; 12; 3; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 3; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0527_a74de49f-2bc6-40df-9904-7b9dad9b8820 61657-0527 HUMAN OTC DRUG MENOPAUSE CIMICIFUGA RACEMOSASANGUINARIA,SEPIA,BELLADONNA,LACHESIS MUTUS,SULFUR,USTILAGO MAIDIS,PULSATILLA , LIQUID ORAL 19931201 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West ATROPA BELLADONNA; BLACK COHOSH; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SULFUR; USTILAGO MAYDIS 12; 3; 12; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; mL/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0904_6c0b0a09-0e80-4728-b974-6d0202844865 61657-0904 HUMAN OTC DRUG Surgery/Trauma HYPERICUM,ARNICA,SYMPHYTUM OFFICINALE, BELLIS PERENNIS, STAPHYSAGRIA LIQUID ORAL 20110701 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West ARNICA MONTANA FLOWER; BELLIS PERENNIS; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; ST. JOHN'S WORT 200; 12; 6; 12; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0915_6a2bb31c-4326-4bbf-85f3-932a0af4dd28 61657-0915 HUMAN OTC DRUG SMOKE-X ARSENICUM ALBUM,PLANTAGO MAJOR,THUJA OCCIDENTALIS,TABACUM,STAPHYSAGRIA,SACCHARUM OFFICINALE,DAPHNE INDICA,NUX VOMICA,NICOTINUM,LOBELIA INFLATA,KALI PHOSPHORICUM,EUGENIA JAMBOSA,CARBOLICUM ACIDUM,CALADIUM SEGUINUM, LIQUID ORAL 20060720 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West ARSENIC TRIOXIDE; DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; LOBELIA INFLATA; NICOTINE; PHENOL; PLANTAGO MAJOR; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; SUCROSE; SYZYGIUM JAMBOS SEED; THUJA OCCIDENTALIS LEAF; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0952_a84dd078-1a30-422d-9688-e5e90d498912 61657-0952 HUMAN OTC DRUG Thyroid IODIUM,BADIAGA,FUCUS VESICULOSUS,CALCAREAARSENICUM IODATUM, THYROIDINUM,CARBONICA,PULSATILLA,BARYTA CARBONICA, LIQUID ORAL 19960826 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West ARSENIC TRIIODIDE; BARIUM CARBONATE; FUCUS VESICULOSUS; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SPONGILLA LACUSTRIS; THYROID, UNSPECIFIED 12; 12; 3; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0955_fed37642-1e40-4052-adef-dc01942519ad 61657-0955 HUMAN OTC DRUG Total Aluminum Aluminum Metal LIQUID ORAL 20110930 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West ALUMINUM 12 [hp_X]/30mL 61657-0956_bb9abe02-e613-4493-a66f-662b0cae4c35 61657-0956 HUMAN OTC DRUG Total Arsenicum Arsenicum Album LIQUID ORAL 20110815 UNAPPROVED HOMEOPATHIC White Manufacturing Incorporated DBA Micro-West ARSENIC TRIOXIDE 12 [hp_X]/30mL 61657-0957_41fddda7-1980-4571-be85-bacc6e7c0e2d 61657-0957 HUMAN OTC DRUG Total Barium Barium LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC White Manufacturing Incorporated DBA Micro-West BARIUM CARBONATE 12 [hp_X]/30mL 61657-0958_4f010052-15c5-4700-aaaa-41b06908f62f 61657-0958 HUMAN OTC DRUG Total Cadmium CADMIUM SULPHURATUM LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro West CADMIUM SULFIDE 12 [hp_X]/30mL 61657-0959_042da72a-8b2e-4fd6-8632-4563199f37c5 61657-0959 HUMAN OTC DRUG Total Copper CUPRUM METALLICUM LIQUID ORAL 20110630 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West COPPER 12 [hp_X]/30mL 61657-0960_e8a24f55-08bb-474b-af09-10020627a035 61657-0960 HUMAN OTC DRUG Total Lead PLUMBUM METALLICUM LIQUID ORAL 20110630 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West LEAD 12 [hp_X]/30mL 61657-0961_16a16ae2-1371-4b8d-b9ce-94e87defe16e 61657-0961 HUMAN OTC DRUG TOTAL MERCURY MERCURIUS VIVUS LIQUID ORAL 20110101 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West MERCURY 12 [hp_X]/30mL 61657-0962_61f8c010-ee55-4425-9b98-6a32924edc4b 61657-0962 HUMAN OTC DRUG Total Niccolum Niccolum Metallicum LIQUID ORAL 20110830 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West NICKEL 10 [hp_C]/30mL 61657-0963_90e4c9cd-8de4-4bbc-9b5d-779ac6b434c2 61657-0963 HUMAN OTC DRUG Total Radium Radium Bromide LIQUID ORAL 20110830 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West RADIUM BROMIDE 10 [hp_C]/30mL 61657-0964_c295ca6e-274a-4658-ae88-a94794e5e2b8 61657-0964 HUMAN OTC DRUG Total Thallium thallium LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West THALLIUM 12 [hp_X]/30mL 61657-0965_43754d4e-dd09-452a-bee7-7edeffadc021 61657-0965 HUMAN OTC DRUG Total Uranium Uranium Nitricum LIQUID ORAL 20110801 UNAPPROVED HOMEOPATHIC White Manufacturing Inc, DBA Micro-West URANYL NITRATE HEXAHYDRATE 15 [hp_X]/30mL 61657-0966_7772fb92-cb1b-4d6a-82d0-a7f7ee4d96ef 61657-0966 HUMAN OTC DRUG Total Antimony antimonium tartaricum LIQUID ORAL 20110713 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro -West ANTIMONY POTASSIUM TARTRATE 12 [hp_X]/30mL 61657-0967_2a24aa66-7c87-4f81-a4d3-2f0b450ef6f6 61657-0967 HUMAN OTC DRUG TOTAL TIN STANNUM METALLICUM LIQUID ORAL 20110615 UNAPPROVED HOMEOPATHIC WHITE MANUFACTURING INC. DBA MICRO WEST TIN 12 [hp_X]/30mL 61657-0968_ed7f4671-62cf-4f14-891d-71e6bab5eee8 61657-0968 HUMAN OTC DRUG Total FLU-CLD 1 ARSENICUM ALBUM,SULPHUR,ANAS BARBARIAE,WYETHIA HELENIOIDES,SARCOLACTICUM ACIDUM,RHUS TOXICODENDRON,PHYTOLACCA DECANDRA,LACHESIS MUTUS,GELSEMIUM SEMPERVIRENS,EUCALYPTUS GLOBULUS,ECHINACEA PURPUREA,EUPATORIUM PERFOLIATUM,DULCAMARA,,CINCHONA OFFICINALIS,BRYONIA ALBA,CAUSTICUM,BAPTISIA TINCTORIA, LIQUID NASAL 20070319 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; CAUSTICUM; CINCHONA OFFICINALIS BARK; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; LACHESIS MUTA VENOM; LACTIC ACID, L-; PHYTOLACCA AMERICANA ROOT; SOLANUM DULCAMARA FLOWER; SULFUR; TOXICODENDRON PUBESCENS LEAF; WYETHIA HELENIOIDES ROOT 10; 10; 10; 35; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0969_bcb06e82-7dcf-4b0b-9cc0-e4d2985d2653 61657-0969 HUMAN OTC DRUG Total Tri-Estro Adrenalinum,Cimicfuga Racemosa,Ignatia Amara,Nicotinamide,Sepia,Estradiol,Oophorinum,Estriol,Estrone LIQUID ORAL 20070401 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West BLACK COHOSH; EGG PHOSPHOLIPIDS; EPINEPHRINE; ESTRADIOL; ESTRIOL; ESTRONE; NIACINAMIDE; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; SUS SCROFA OVARY 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0970_aa6655d5-6e99-4f6b-b317-1bcb158d02b3 61657-0970 HUMAN OTC DRUG TOTAL ANDRO-BAL DAMIANA, LECITHINUM,PHOSPHORICUM ACIDUM,SABAL SERRATA, CHOSESTERINUM,DNA,HYPOTHALAMUS,ADRENAL CORTEX, DHEA,PREGNENOLONE,PROGESTERONE,TESTOSTERONE LIQUID ORAL 20070401 UNAPPROVED HOMEOPATHIC WHITE MANUFACTURING INC. DBA MICRO WEST BOS TAURUS HYPOTHALAMUS; CHOLESTEROL; EGG PHOSPHOLIPIDS; HERRING SPERM DNA; PHOSPHORIC ACID; PRASTERONE; PREGNENOLONE; PROGESTERONE; SAW PALMETTO; SUS SCROFA ADRENAL GLAND; TESTOSTERONE; TURNERA DIFFUSA LEAFY TWIG 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0971_41aa131b-f353-4a65-9b7e-451e7beafc9b 61657-0971 HUMAN OTC DRUG TOTAL FEM-BAL ADRENALINUM,PULSATILLA,CHOLESTERINUM,FOLLICULINUM,HYPOTHALAMUS,OOPHORINUM,ADRENAL CORTEX, ANDROSTENEDIONE,DHEA,PREGNANOLONE,PROGESTERONE,TESTERONE LIQUID ORAL 20070402 UNAPPROVED HOMEOPATHIC WHITE MANUFACTURING INC. DBA MICRO WEST ANDROSTENEDIONE; BOS TAURUS HYPOTHALAMUS; CHOLESTEROL; EPINEPHRINE; ESTRONE; PRASTERONE; PREGNENOLONE; PROGESTERONE; PULSATILLA VULGARIS; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; TESTOSTERONE 30; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-0972_ccfcc191-316f-4502-be6b-736e9a852257 61657-0972 HUMAN OTC DRUG Total Bromine Bromine LIQUID ORAL 20110729 UNAPPROVED HOMEOPATHIC White Manufacturing Incorporated DBA Micro-West BROMINE 15 [hp_X]/30mL 61657-0973_8247cc17-dc8d-449b-b530-90f44e81f71b 61657-0973 HUMAN OTC DRUG Total Chlorine Chlorinum LIQUID ORAL 20110815 UNAPPROVED HOMEOPATHIC White Manufacturing Incorporated DBA Micro-West CHLORINE 15 [hp_X]/30mL 61657-0974_bb9c54c5-715f-4055-90bd-b7866b8fd9f6 61657-0974 HUMAN OTC DRUG TOTAL PRO-JES ADRENAL,BELLADONNA,CHELIDONIUM,DIOSCOREAVILLOSA,FOLLICULINUM,HYPOTHALAMUS,ARGININE,LILIumTIGRINIUM,LIVER,OOPHORINUM,PINEAL,PITUITARINUM,PLACENTANIUM,PROGESTERONE LIQUID ORAL 20110915 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. BDA Micro-West ARGININE; ATROPA BELLADONNA; BOS TAURUS HYPOTHALAMUS; BOS TAURUS PINEAL GLAND; BOS TAURUS PITUITARY GLAND; CHELIDONIUM MAJUS; DIOSCOREA VILLOSA ROOT; EPINEPHRINE; ESTRONE; LILIUM LANCIFOLIUM FLOWERING TOP; MAMMAL LIVER; PROGESTERONE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SULFUR; SUS SCROFA OVARY; SUS SCROFA PLACENTA 6; 6; 6; 6; 6; 6; 6; 6; 6; 12; 6; 6; 12; 12; 12; 6; 6 [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL 61657-1026_99aedc91-5acf-4f8a-8e40-ef8d0aa3fed1 61657-1026 HUMAN OTC DRUG Vermafuge -AG Lycopodium NUX VOMICA,ARSENICUM ALBUM,CINCHONA OFFICINALIS,CAPSICUM ANNUUM,NITRIC ACID,MERCURIUSCORROSIVUS,BELLADONNA,CAJUPUTUM,LYCOPODIUM CLAVATUM,PHOSPHORUS,PHYTOLACCA DECANDRA,RHAMNUS PURSHIANA,FRAGARIA VESCA LIQUID ORAL 19930803 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West ALPINE STRAWBERRY; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CAJUPUT OIL; CAPSICUM; CINCHONA OFFICINALIS BARK; FRANGULA PURSHIANA BARK; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; NITRIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; STRYCHNOS NUX-VOMICA SEED 12; 12; 12; 4; 3; 12; 3; 12; 12; 12; 12; 6; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61657-1027_1346f883-a93e-4798-8b79-5fc008e341c8 61657-1027 HUMAN OTC DRUG VIREX ARSENIC TRIOXIDE,ECHINACEA,ATROPA BELLADONNA,TOXICODENDRON PUBESCENS LEAF,LYCOPODIUM CLAVATUM SPORE,STRYCHNOS NUX-VOMICA SEED,GELSEMIUM SEMPERVIRENS ROOT, LIQUID ORAL 20110729 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro West ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; FOSCOLIC ACID; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; RANCID BEEF; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 12; 12; 3; 3; 12; 12; 12; 12; 12; 30; 12; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 61666-000_c7dcb44b-de90-46ed-a62d-bf755050db31 61666-000 HUMAN OTC DRUG Clear-Tone Antibacterial Hand CHLOROXYLENOL SOAP TOPICAL 20140107 OTC MONOGRAPH NOT FINAL part333A Waxie Sanitary Supply CHLOROXYLENOL 2.5 mg/mL 61666-001_e7839bb0-9e91-4807-9838-40e351c61b3e 61666-001 HUMAN OTC DRUG ANTIBACTERIAL HAND CHLOROXYLENOL SOAP TOPICAL 20140107 OTC MONOGRAPH NOT FINAL part333A Waxie Sanitary Supply CHLOROXYLENOL 2.5 mg/mL 61666-002_cd9a8afa-5e2f-44a2-b23f-5672d76a195d 61666-002 HUMAN OTC DRUG ANTIBACTERIAL HAND CHLOROXYLENOL SOAP TOPICAL 20140107 OTC MONOGRAPH NOT FINAL part333A Waxie Sanitary Supply CHLOROXYLENOL 2.5 mg/mL 61667-001_7d09d13c-0809-48ae-affb-7178e2f1aa02 61667-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS Baystate Home Infusion & Respiratory Services OXYGEN 99 L/100L 61671-003_de7705b6-2bbd-430f-85f1-b82ac4d319dd 61671-003 HUMAN OTC DRUG Body Scrub Glycerin and Kaolin GEL TOPICAL 20140108 OTC MONOGRAPH FINAL part347 Milk & Co Pty Ltd GLYCERIN; KAOLIN 7.5; 6 g/375g; g/375g 61671-004_e4206daf-0b70-4e4c-adf1-40ffb9c8ded9 61671-004 HUMAN OTC DRUG Face Moisturiser Avobenzone and Octinoxate LOTION TOPICAL 20140108 OTC MONOGRAPH NOT FINAL part352 Milk & Co Pty Ltd AVOBENZONE; OCTINOXATE 3; 7 g/150g; g/150g 61680-0622_5d7ffd74-1b8e-432c-9ac9-071c0d729c04 61680-0622 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19950622 UNAPPROVED MEDICAL GAS South East Alaska Medical Suppliers Inc. OXYGEN 99 L/100L 61699-0047_0215200c-b492-43b5-a62d-248b0df55cf4 61699-0047 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140718 NDA NDA011856 US MedSource, LLC METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61699-0201_8c77a533-c7d7-43d2-802e-09a333d82a56 61699-0201 HUMAN PRESCRIPTION DRUG Lidocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20140702 ANDA ANDA080404 US MedSource, LLC LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 61699-1966_8e4ff226-d15f-49d5-a09d-47e6b3c1471d 61699-1966 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION INTRAVENOUS 20140725 NDA NDA018800 US MedSource, LLC SODIUM CHLORIDE 9 mg/mL 61699-3178_18c4753b-0899-4d27-beff-65b5e4aaff02 61699-3178 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20140612 ANDA ANDA089644 US MedSource, LLC EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 10 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 61699-3182_8307126e-bba5-4993-a315-d9a51fa15315 61699-3182 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20140614 ANDA ANDA089646 US MedSource, LLC EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 20 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 61699-3977_6e65e7f5-4fc6-4e62-ba43-0848fb4a8cb7 61699-3977 HUMAN PRESCRIPTION DRUG Bacteriostatic Water WATER INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20140707 NDA NDA018802 US MedSource, LLC WATER 1 mL/mL 61699-4276_65cfa1eb-a6ee-4309-a609-6cf23063e505 61699-4276 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20140529 ANDA ANDA088299 US MedSource, LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 61699-4277_8d7badf9-a36c-40c0-a205-5dce6cdc2994 61699-4277 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20140612 ANDA ANDA088327 US MedSource, LLC LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 61699-4888_94b8a474-b1c7-4dc3-a915-c6c1ed2baf51 61699-4888 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20140619 NDA NDA018803 US MedSource, LLC SODIUM CHLORIDE 9 mg/mL 61699-6625_4465436b-27a9-4380-810e-f9009ac75a0b 61699-6625 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20140703 UNAPPROVED DRUG OTHER US MedSource, LLC SODIUM BICARBONATE 84 mg/mL 61703-303_538b7e91-c950-4be0-a437-cbe792267d81 61703-303 HUMAN PRESCRIPTION DRUG CYTARABINE CYTARABINE INJECTION, SOLUTION INTRAVENOUS 19900831 ANDA ANDA072168 Hospira Worldwide, Inc. CYTARABINE 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 61703-304_5e850aab-0acf-402e-be54-08370ff31af9 61703-304 HUMAN PRESCRIPTION DRUG Cytarabine CYTARABINE SOLUTION INTRAVENOUS; SUBCUTANEOUS 19940228 ANDA ANDA072945 Hospira Worldwide, Inc. CYTARABINE 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 61703-305_d681b0bc-4b87-4b3b-80c6-52e3a8510878 61703-305 HUMAN PRESCRIPTION DRUG Cytarabine CYTARABINE INJECTION, SOLUTION INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS 19900604 ANDA ANDA071868 Hospira Worldwide, Inc. CYTARABINE 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 61703-309_bb9bd63c-1df6-4ccd-a73b-5f8b0f79e8b9 61703-309 HUMAN PRESCRIPTION DRUG VinCRIStine Sulfate VINCRISTINE SULFATE INJECTION, SOLUTION INTRAVENOUS 19880419 ANDA ANDA071484 Hospira Worldwide, Inc. VINCRISTINE SULFATE 1 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 61703-319_d681b0bc-4b87-4b3b-80c6-52e3a8510878 61703-319 HUMAN PRESCRIPTION DRUG Cytarabine CYTARABINE INJECTION, SOLUTION INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS 19991122 ANDA ANDA075383 Hospira Worldwide, Inc. CYTARABINE 100 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 61703-323_1f24a776-23c8-4a13-9bc0-c09da32c2a61 61703-323 HUMAN PRESCRIPTION DRUG Bleomycin BLEOMYCIN SULFATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS 20000310 ANDA ANDA065031 Hospira Worldwide, Inc. BLEOMYCIN SULFATE 30 [USP'U]/1 Cytoprotective Agent [EPC] 61703-324_078bd234-47c8-4d05-89cb-325ec7fc38ed 61703-324 HUMAN PRESCRIPTION DRUG Pamidronate Disodium PAMIDRONATE DISODIUM INJECTION, SOLUTION INTRAVENOUS 20020627 ANDA ANDA075841 Hospira Worldwide, Inc. PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 61703-325_078bd234-47c8-4d05-89cb-325ec7fc38ed 61703-325 HUMAN PRESCRIPTION DRUG Pamidronate Disodium PAMIDRONATE DISODIUM INJECTION, SOLUTION INTRAVENOUS 20020627 ANDA ANDA075841 Hospira Worldwide, Inc. PAMIDRONATE DISODIUM 6 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 61703-326_078bd234-47c8-4d05-89cb-325ec7fc38ed 61703-326 HUMAN PRESCRIPTION DRUG Pamidronate Disodium PAMIDRONATE DISODIUM INJECTION, SOLUTION INTRAVENOUS 20020627 ANDA ANDA075841 Hospira Worldwide, Inc. PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 61703-327_a5c7f4a6-2c21-47e9-b0d2-0b76c66ff6d6 61703-327 HUMAN PRESCRIPTION DRUG Dacarbazine DACARBAZINE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110923 ANDA ANDA075940 Hospira Worldwide, Inc. DACARBAZINE 200 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 61703-332_1f24a776-23c8-4a13-9bc0-c09da32c2a61 61703-332 HUMAN PRESCRIPTION DRUG Bleomycin BLEOMYCIN SULFATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS 20000310 ANDA ANDA065031 Hospira Worldwide, Inc. BLEOMYCIN SULFATE 15 [USP'U]/1 Cytoprotective Agent [EPC] 61703-339_e7fa8b6b-4ce8-45c8-b961-603c041b11f3 61703-339 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION, SOLUTION INTRAVENOUS 20091217 ANDA ANDA076517 Hospira Worldwide, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 61703-341_3e2fde7f-9a02-49f7-88e6-64a4fa2f8c2b 61703-341 HUMAN PRESCRIPTION DRUG Vinorelbine Tartrate VINORELBINE TARTRATE INJECTION, SOLUTION INTRAVENOUS 20050602 ANDA ANDA076827 Hospira Worldwide, Inc. VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 61703-342_4548f338-48ec-4d47-934a-34d6ddf31146 61703-342 HUMAN PRESCRIPTION DRUG Paclitaxel PACLITAXEL INJECTION, SOLUTION INTRAVENOUS 20020508 ANDA ANDA076131 Hospira Worldwide, Inc. PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 61703-343_23cf4a44-eb54-4497-b272-c97365ba7fca 61703-343 HUMAN PRESCRIPTION DRUG Mitoxantrone MITOXANTRONE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060411 ANDA ANDA076871 Hospira Worldwide, Inc. MITOXANTRONE HYDROCHLORIDE 2 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 61703-344_0dedead3-2643-4b82-8329-a3ddf74a8adb 61703-344 HUMAN PRESCRIPTION DRUG Fludarabine Phosphate FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20070406 ANDA ANDA077790 Hospira Worldwide, Inc. FLUDARABINE PHOSPHATE 50 mg/2mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 61703-349_08caa25e-eab6-40d8-a7cf-45ec23713ee0 61703-349 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20080227 ANDA ANDA077915 Hospira Worldwide, Inc. IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 61703-350_0e30eaef-5a09-4104-8a11-c32933eadeab 61703-350 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate Sodium INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRAVENOUS 20140925 NDA NDA011719 Hospira Worldwide, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 61703-350_b6d9b994-f43b-4077-b065-9e2bfdabced8 61703-350 HUMAN PRESCRIPTION DRUG Methotrexate METHOTREXATE SODIUM INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRAVENOUS 20041215 NDA NDA011719 Hospira Worldwide, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 61703-359_fc347d1f-4e80-4157-90aa-d2f0018d53c5 61703-359 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride EPIRUBICIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20070419 ANDA ANDA065343 Hospira Worldwide, Inc. EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 61703-360_e7fa8b6b-4ce8-45c8-b961-603c041b11f3 61703-360 HUMAN PRESCRIPTION DRUG Carboplatin CARBOPLATIN INJECTION, SOLUTION INTRAVENOUS 20091217 ANDA ANDA076517 Hospira Worldwide, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 61703-361_3b0d6f39-2395-40cd-a1ca-21a07d15d53f 61703-361 HUMAN PRESCRIPTION DRUG Oxaliplatin OXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110908 ANDA ANDA078815 Hospira Worldwide, Inc. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 61703-362_3b0d6f39-2395-40cd-a1ca-21a07d15d53f 61703-362 HUMAN PRESCRIPTION DRUG Oxaliplatin OXALIPLATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110908 ANDA ANDA078815 Hospira Worldwide, Inc. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 61703-363_3b0d6f39-2395-40cd-a1ca-21a07d15d53f 61703-363 HUMAN PRESCRIPTION DRUG Oxaliplatin OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090825 ANDA ANDA078813 Hospira Worldwide, Inc. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 61703-408_1530bbd2-321d-49bb-a991-a39c219dd6b3 61703-408 HUMAN PRESCRIPTION DRUG Methotrexate METHOTREXATE SODIUM INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20050413 NDA NDA011719 Hospira Worldwide, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 61703-408_b6d9b994-f43b-4077-b065-9e2bfdabced8 61703-408 HUMAN PRESCRIPTION DRUG Methotrexate METHOTREXATE SODIUM INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20050413 NDA NDA011719 Hospira Worldwide, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 61703-418_dba45253-35a2-4213-ae5e-a7c68ece5f5f 61703-418 HUMAN PRESCRIPTION DRUG AQUASOL A VITAMIN A PALMITATE INJECTION, SOLUTION INTRAMUSCULAR 19490518 NDA NDA006823 Hospira Worldwide, Inc. VITAMIN A PALMITATE 15 mg/mL 61703-421_61bb27ab-f228-4343-9c4d-9ecb8b1476b1 61703-421 HUMAN PRESCRIPTION DRUG Multi Vitamin Infusion Pediatric ASCORBIC ACID, RETINOL, ERGOCALCIFEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, PYRIDOXINE HYDROCHLORIDE, NIACINAMIDE, DEXPANTHENOL, .ALPHA.-TOCOPHEROL ACETATE, DL-, BIOTIN, FOLIC ACID, CYANOCOBALAMIN, and PHYTONADIONE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19830406 NDA NDA018920 Hospira Worldwide, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RETINOL; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE 7; 80; 20; 1; 5; 10; 140; 17; 200; 1; .7; 1.4; 1.2 mg/5mL; mg/5mL; ug/5mL; ug/5mL; mg/5mL; ug/5mL; ug/5mL; mg/5mL; ug/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 61703-422_5bd53dd7-2fa2-427a-92bb-cc03a2dc3b4c 61703-422 HUMAN PRESCRIPTION DRUG Multi Vitamin Infusion Adult RETINOL, ERGOCALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PHYTONADIONE, ASCORBIC ACID, NIACINAMIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, THIAMINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE, DEXPANTHENOL, BIOTIN, FOLIC ACID, and CYANOCOBALAMIN INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20120206 NDA NDA021643 Hospira Worldwide, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RETINOL; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE 10; 200; 60; 5; 15; 5; 600; 40; 150; 6; 1; 3.6; 6 mg/10mL; mg/10mL; ug/10mL; ug/10mL; mg/10mL; ug/10mL; ug/10mL; mg/10mL; ug/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 61703-422_a0898ca9-2100-4a05-b0be-326b14c5468d 61703-422 HUMAN PRESCRIPTION DRUG Multi Vitamin Infusion Adult RETINOL, ERGOCALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PHYTONADIONE, ASCORBIC ACID, NIACINAMIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, THIAMINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE, DEXPANTHENOL, BIOTIN, FOLIC ACID, and CYANOCOBALAMIN INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20120206 NDA NDA021625 Hospira Worldwide, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RETINOL; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE 10; 200; 60; 5; 15; 5; 600; 40; 150; 6; 1; 3.6; 6 mg/10mL; mg/10mL; ug/10mL; ug/10mL; mg/10mL; ug/10mL; ug/10mL; mg/10mL; ug/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 61703-423_8da8c323-c1a5-4bf3-b5a0-2e76ec40451e 61703-423 HUMAN PRESCRIPTION DRUG Multi Vitamin Infusion RETINOL, ERGOCALCIFEROL, ASCORBIC ACID, NIACINAMIDE, THIAMINE, BIOTIN, FOLIC ACID, CYANOCOBALAMIN, .ALPHA.-TOCOPHEROL ACETATE, DL-, RIBOFLAVIN 5-PHOSPHATE SODIUM, PYRIDOXINE HYDROCHLORIDE, and DEXPANTHENOL INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20040909 NDA NDA008809 Hospira Worldwide, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE 10; 200; 60; 5; 15; 5; 600; 40; 6; 1; 3.6; 6 mg/10mL; mg/10mL; ug/10mL; ug/10mL; mg/10mL; ug/10mL; ug/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 61703-423_ef189094-4bf7-4bf3-9f11-dec4f4d12945 61703-423 HUMAN PRESCRIPTION DRUG MULTI VITAMIN INFUSION RETINOL, ERGOCALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, NIACINAMIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, THIAMINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE, DEXPANTHENOL, BIOTIN, FOLIC ACID, and CYANOCOBALAMIN INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20040909 NDA NDA008809 Hospira Worldwide, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE 10; 200; 60; 5; 15; 5; 600; 40; 6; 1; 3.6; 6 mg/10mL; mg/10mL; ug/10mL; ug/10mL; mg/10mL; ug/10mL; ug/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 61715-010_fe8a218f-94dd-485d-b42c-dbfbf7e5b3a5 61715-010 HUMAN OTC DRUG Stay Awake CAFFEINE TABLET ORAL 20130509 OTC MONOGRAPH FINAL part340 Kinray Inc. CAFFEINE 200 mg/1 61715-011_25a01ed7-1704-4cfb-8ff0-69d390019f61 61715-011 HUMAN OTC DRUG Sinus Congestion and Pain Severe ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130509 OTC MONOGRAPH FINAL part341 Kinray Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 61715-012_c7ceb971-4f74-43c2-96af-1ae13fc9a98c 61715-012 HUMAN OTC DRUG Preferred Plus Chest Congestion Relief Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Kinray GUAIFENESIN 400 mg/1 61715-013_d5676d5d-9361-4fbc-8608-092f14d70ce1 61715-013 HUMAN OTC DRUG Preferred Plus Chest Congestion Relief DMTDM TDM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Kinray DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 61715-014_db128f5a-6a92-45d3-ba1a-61d9c601a4f4 61715-014 HUMAN OTC DRUG Preferred Plus Chest Congestion Relief PE Guaifenesin/phenylephrine TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 Kinray GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 61715-015_1fad27f7-d39a-479a-84b2-1dd4d3cb1cf3 61715-015 HUMAN OTC DRUG Preferred Plus Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20100104 UNAPPROVED DRUG OTHER Kinray PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 61715-016_9edc1bd1-94f1-46a1-87bc-7f2781e4757b 61715-016 HUMAN OTC DRUG Loratadine and Pseudoephedrine Loratadine and Pseudoephedrine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Kinray LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 61715-017_de98b206-8dbe-42f1-82ac-8c1f92a9e1af 61715-017 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Kinray LORATADINE 10 mg/1 61715-018_202ac623-305a-4005-bf14-ee5c4f276d0f 61715-018 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20111122 ANDA ANDA091355 Kinray IBUPROFEN 200 mg/1 61715-019_cf166ebb-d7d8-4a5e-921b-514d8576ca07 61715-019 HUMAN OTC DRUG Senna-S Sennosides and Docusate Sodium TABLET, FILM COATED ORAL 20110510 OTC MONOGRAPH NOT FINAL part334 Kinray Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 61715-020_eeccc94f-173f-464a-848b-473ac2d480ce 61715-020 HUMAN OTC DRUG Pain Relief BalmPreferred Plus Ph Preferred Plus Pharmacy Menthol GEL TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part348 Kinray Inc. MENTHOL; METHYL SALICYLATE .076; .29 g/100g; g/100g 61715-021_a5923fe0-836d-47a7-ace1-1dcbf94f318b 61715-021 HUMAN OTC DRUG Therapeutic Relief Preferred Plus Pharmacy Menthol GEL TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part348 Kinray Inc. MENTHOL 2 g/100g 61715-022_4556921a-0003-445b-99d5-189b53abf778 61715-022 HUMAN OTC DRUG Burn ReliefPreferred Plus Ph Preferred Plus Pharmacy Lidocaine HCl GEL TOPICAL 20130315 OTC MONOGRAPH FINAL part348 Kinray Inc. LIDOCAINE HYDROCHLORIDE .5 g/100mL 61715-023_e0b2e235-9b25-462f-8b3d-6d668db6b053 61715-023 HUMAN OTC DRUG Broad Spectrum SPF 15 Preferred Plus Pharmacy Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kinray Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL 61715-024_1d9c7ffe-89e9-4493-8ad2-ae956dfb0b37 61715-024 HUMAN OTC DRUG Broad Spectrum SPF 30 Preferred Plus Pharmacy Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kinray Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100mL; g/100mL; g/100mL; g/100mL; 1/100mL 61715-025_27dc87f1-9753-4838-b0f6-ea7fa7742181 61715-025 HUMAN OTC DRUG Broad Spectrum SPF 30 Sunscreen Preferred Plus Pharmacy Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kinray Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL 61715-026_b57772cf-ef47-422b-beb9-f83c452b7be2 61715-026 HUMAN OTC DRUG Broad Spectrum SPF 30 Sunscreen Preferred Plus Pharmacy Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kinray Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 61715-027_2d039560-eeec-4c76-a40d-34f0bfa6a5c9 61715-027 HUMAN OTC DRUG Broad Spectrum SPF 50 Baby Sunscreen Preferred Plus Pharmacy Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kinray Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 61715-028_8ef7c868-97a7-449f-89ee-d737a92f85c0 61715-028 HUMAN OTC DRUG Broad Spectrum SPF 50 Kids Preferred Plus Pharmacy Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kinray Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 61715-029_22dc6a8c-3ab6-44bf-bb40-9e04074e1b90 61715-029 HUMAN OTC DRUG Broad Spectrum SPF 50 Sunscreen Preferred Plus Pharmacy Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kinray Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 61715-030_196452d5-81ce-4cd8-9853-f5ae585c59cb 61715-030 HUMAN OTC DRUG Broad Spectrum SPF 70 Sunscreen Preferred Plus Pharmacy Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kinray Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 61715-031_9f1b1f17-5aaf-4533-b0f5-84a848a1895a 61715-031 HUMAN OTC DRUG Ear Wax Removing Drops Carbamide Peroxide Preferred Plus LIQUID AURICULAR (OTIC) 20130315 OTC MONOGRAPH FINAL part344 Kinray Inc CARBAMIDE PEROXIDE 6.5 g/100mL 61715-032_1d4c86d3-c2ba-4cd6-8f3d-e1600ba9f75e 61715-032 HUMAN OTC DRUG Preferred Plus Arthritis Cream menthol topical analgesic CREAM TOPICAL 20010423 UNAPPROVED DRUG OTHER Kinray CAPSAICIN; MENTHOL; METHYL SALICYLATE .025; 10; 15 g/100g; g/100g; g/100g 61715-033_deeb277e-284b-4f9b-80cd-c75c87c55d2e 61715-033 HUMAN OTC DRUG Preferred Plus Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20010423 UNAPPROVED DRUG OTHER Kinray PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 61715-035_affafdff-4b91-4ab1-bb85-d3b6983f443e 61715-035 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE ORAL 20100713 OTC MONOGRAPH NOT FINAL part334 Preferred Plus (Kinray) DOCUSATE SODIUM 100 mg/1 61715-037_70f36a17-a264-48a7-a4b3-e5f0df61ce38 61715-037 HUMAN OTC DRUG stool softener plus stimulant laxative docusate sodium and sennosides TABLET ORAL 20100715 OTC MONOGRAPH NOT FINAL part334 Preferred Plus (Kinray) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 61715-038_0eb39534-0725-490a-8752-7c0499489ffb 61715-038 HUMAN OTC DRUG Stimulant Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20100713 OTC MONOGRAPH NOT FINAL part334 Preferred Plus (Kinray) BISACODYL 5 mg/1 61715-039_21837bdc-65e0-480c-8aa3-b54fee034275 61715-039 HUMAN OTC DRUG WOMENS GENTLE LAXATIVE Bisacodyl TABLET, COATED ORAL 20100802 OTC MONOGRAPH NOT FINAL part334 Preferred Plus (Kinray) BISACODYL 5 mg/1 61715-040_dd417517-9abb-4412-a7f3-cf30a46f5a3e 61715-040 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET ORAL 20130331 OTC MONOGRAPH FINAL part343 Preferred Plus (Kinray) ASPIRIN 81 mg/1 61715-041_dcb87df9-8505-4189-ba68-a0035446138a 61715-041 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl TABLET ORAL 20101026 OTC MONOGRAPH FINAL part336 Preferred Plus (Kinray) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 61715-042_f8fb3a86-3773-47e0-af6d-9404a5736f96 61715-042 HUMAN OTC DRUG Day Time Cold and Flu Multi-Symptom Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130331 OTC MONOGRAPH FINAL part341 Preferred Plus (Kinray) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 61715-043_4b4dc419-4f75-4921-bca4-b3ab7217607f 61715-043 HUMAN OTC DRUG Nite-Time Cold and Flu Multi-Symptom Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130331 OTC MONOGRAPH FINAL part341 Preferred Plus (Kinray) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 61715-044_511ee232-6e7b-4a87-8a61-c41a0321756c 61715-044 HUMAN OTC DRUG Nasal Decongestant PE Maximum Strength Phenylephrine Hydrochloride TABLET ORAL 20100707 OTC MONOGRAPH FINAL part341 Preferred Plus (Kinray) PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 61715-045_762d817d-d8cc-4379-adca-35c99bfeec1b 61715-045 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20100707 OTC MONOGRAPH FINAL part332 Preferred Plus (Kinray) DIMETHICONE 180 mg/1 61715-046_49d4fbaa-2f26-4360-8a72-e8f3925fe030 61715-046 HUMAN OTC DRUG AntiGas Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100713 OTC MONOGRAPH FINAL part332 Preferred Plus (Kinray) DIMETHICONE 125 mg/1 61715-047_7ebe00a6-b1e0-46a9-8fe2-b5af851daa7d 61715-047 HUMAN OTC DRUG Preferred Plus 12 Hour Nasal Extra Moisturizing Oxymetazoline Hydrochloride SPRAY NASAL 20080131 OTC MONOGRAPH FINAL part341 Kinray OXYMETAZOLINE HYDROCHLORIDE 50 mg/100mL 61715-048_56013e78-1101-469b-a89c-714dcbe74947 61715-048 HUMAN OTC DRUG Preferred Plus 12 Hour Nasal Original Oxymetazoline Hydrochloride SPRAY NASAL 20080131 OTC MONOGRAPH FINAL part341 Kinray OXYMETAZOLINE HYDROCHLORIDE 50 mg/100mL 61715-049_4f8e7ba2-4eb4-4ad3-8ee6-6ff122fed21c 61715-049 HUMAN OTC DRUG Fexofenadine HCl Fexofenadine HCl TABLET ORAL 20130331 ANDA ANDA079112 Preferred Plus (Kinray) FEXOFENADINE HYDROCHLORIDE 180 mg/1 61715-050_992d15f8-5987-40c7-886f-a6cab93f6820 61715-050 HUMAN OTC DRUG MICONAZOLE MICONAZOLE CREAM TOPICAL 20130321 OTC MONOGRAPH FINAL part333C Kinray, Inc. MICONAZOLE NITRATE 20 mg/g 61715-051_9b520434-53f2-4ec5-9aa1-5331d30bbabe 61715-051 HUMAN OTC DRUG PREFERRED PLUS MEDICATED LIP BALM MEDICATED LIP BALM STICK TOPICAL 20070228 UNAPPROVED DRUG OTHER Kinray CAMPHOR (SYNTHETIC); MENTHOL; PHENOL 17; 7; 4 mg/g; mg/g; mg/g 61715-052_7a7eb443-1cee-4e90-bec2-a34772314547 61715-052 HUMAN OTC DRUG Preferred Plus Extra Strength Pain Relief Acetaminophen TABLET ORAL 20130626 OTC MONOGRAPH NOT FINAL part343 Kinray ACETAMINOPHEN 500 mg/1 61715-053_08db7699-e25d-4d10-9d06-e0b2435a3149 61715-053 HUMAN OTC DRUG Preferred Plus Ibuprofen 200 Ibuprofen TABLET ORAL 20130626 OTC MONOGRAPH NOT FINAL part343 Kinray IBUPROFEN 200 mg/1 61715-054_bdd9b32e-449f-4f1c-9e4c-3dabc5876f31 61715-054 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100830 ANDA ANDA078682 Preferred Plus (Kinray) IBUPROFEN 200 mg/1 61715-055_cf1eef15-fff0-4590-b602-cf28fbe967f8 61715-055 HUMAN OTC DRUG Preferred Plus Complete Allergy Medicine Diphenhydramine Hydrochloride CAPSULE ORAL 20130507 OTC MONOGRAPH FINAL part341 Kinray Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 61715-056_f244464e-5f53-4d51-af45-427cf91a3df0 61715-056 HUMAN OTC DRUG Preferred Plus Senna Gentle Natural Vegetable Laxative Sennosides TABLET, FILM COATED ORAL 20130507 OTC MONOGRAPH NOT FINAL part334 Kinray Inc. SENNOSIDES 8.6 mg/1 61715-057_28835a86-b0f8-400e-9c26-cd077955d640 61715-057 HUMAN OTC DRUG Preferred Plus Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130511 ANDA ANDA079129 Kinray, Inc. IBUPROFEN 200 mg/1 61715-058_c6eab715-b3a3-40af-bc77-8d3c0c99e007 61715-058 HUMAN OTC DRUG ANTACID Calcium Carbonate TABLET, CHEWABLE ORAL 20130628 OTC MONOGRAPH FINAL part331 Kinray Inc. CALCIUM CARBONATE 500 mg/1 61715-059_24471a0d-6862-475c-9586-e78b4c6897f9 61715-059 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110725 ANDA ANDA091239 Kinray IBUPROFEN 200 mg/1 61715-060_02d3fae4-c0a8-4071-9ac1-8b10028f400c 61715-060 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20091125 ANDA ANDA079096 Kinray NAPROXEN SODIUM 220 mg/1 61715-061_c1b1f1ae-db9d-4326-996b-af018abb687b 61715-061 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110725 ANDA ANDA091239 Kinray IBUPROFEN 200 mg/1 61715-062_3bc89c6b-418f-47dc-89dd-bddaf5bbcb38 61715-062 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20111207 ANDA ANDA077498 Kinray CETIRIZINE HYDROCHLORIDE 10 mg/1 61715-063_c72f6118-d58c-46ae-87b1-107a47113237 61715-063 HUMAN OTC DRUG Famotidine famotidine TABLET, FILM COATED ORAL 20111003 ANDA ANDA090283 Kinray FAMOTIDINE 10 mg/1 61715-064_c72f6118-d58c-46ae-87b1-107a47113237 61715-064 HUMAN OTC DRUG Famotidine famotidine TABLET, FILM COATED ORAL 20120215 ANDA ANDA090283 Kinray FAMOTIDINE 20 mg/1 61715-065_9c184378-29e5-4548-86b5-768ee805dece 61715-065 HUMAN OTC DRUG Preferred Plus TabTussin Guaifenesin TABLET ORAL 20110926 OTC MONOGRAPH FINAL part341 Kinray GUAIFENESIN 400 mg/1 61715-066_77c7e6a8-cae5-4bfc-a8ee-7c50943235aa 61715-066 HUMAN OTC DRUG Preferred Plus TabTussin DM DMTDM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Kinray DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 61715-068_bc7df9c1-3c93-4f84-90d3-51f5ccb491cd 61715-068 HUMAN OTC DRUG Acetaminophen Sinus Congestion and Pain Daytime ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 Kinray Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 61715-069_42bad289-1b1c-4071-818c-073ac880bf8c 61715-069 HUMAN OTC DRUG KPP Triple Action Menthol POWDER TOPICAL 20101031 OTC MONOGRAPH NOT FINAL part348 Cardinal Health, Inc MENTHOL 1 g/100g 61715-070_0054707d-476d-4272-98a2-68b519673e46 61715-070 HUMAN OTC DRUG KPP Ultra Thin Corn Removers Salicylic Acid PLASTER TOPICAL 19951031 OTC MONOGRAPH FINAL part358F Cardinal Health SALICYLIC ACID 40 1/1 61715-071_bc3d747b-ef50-43c0-80b5-b077cde3f1d2 61715-071 HUMAN OTC DRUG KPP Ultra Thick Medicated Callus Remover Salicylic Acid PLASTER TOPICAL 19951031 OTC MONOGRAPH FINAL part358F Cardinal Health SALICYLIC ACID 40 1/1 61715-072_e193543e-cd2a-4a9d-af49-b351a5017f66 61715-072 HUMAN OTC DRUG Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% LIQUID TOPICAL 20130803 NDA NDA019125 Kinray Inc. CHLORHEXIDINE GLUCONATE 4 mg/100mL 61715-073_e891cc1e-5a2f-4b83-88bd-d2a2df8288e4 61715-073 HUMAN OTC DRUG Preferred Plus Medicated Baby Active Corn Starch POWDER TOPICAL 20101031 OTC MONOGRAPH FINAL part347 Cardinal Health, Inc KAOLIN; STARCH, CORN; ZINC OXIDE 4.52; 89.27; 16.95 g/113g; g/113g; g/113g 61715-074_bf4d3158-769a-4ea0-b3ef-aa9f9b93888e 61715-074 HUMAN OTC DRUG Cough Multi Symptom Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl LIQUID ORAL 20060828 OTC MONOGRAPH FINAL part341 Kinray LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 500; 15; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 61715-075_5bce9baa-fe74-4601-845c-f18a435bba45 61715-075 HUMAN OTC DRUG Cough and Sore Throat Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20060828 OTC MONOGRAPH FINAL part341 Kinray LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 61715-076_7964b13c-641f-43f2-971c-cad1eeb10ebf 61715-076 HUMAN OTC DRUG Cough and Sore Throat Daytime Acetaminophen, Dextromethorphan HBr LIQUID ORAL 20060828 OTC MONOGRAPH FINAL part341 Kinray LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 500; 15 mg/15mL; mg/15mL 61715-077_cbbea11c-45d2-40ea-90f4-2e29fc45aafa 61715-077 HUMAN OTC DRUG Preferred Plus Intense Cough Reliever Dextromethorphan Hydrobromide / Guaifenesin LIQUID ORAL 20110802 OTC MONOGRAPH FINAL part341 Kinray DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 300 mg/5mL; mg/5mL 61715-078_93f2d7fa-0695-4438-865a-157aef341039 61715-078 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SOLUTION ORAL 20140601 ANDA ANDA074916 Preferred Plus (Kinray) IBUPROFEN 100 mg/5mL 61715-079_e55c385f-9c86-4b4e-b9ed-2a44ab6b9d65 61715-079 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20130802 OTC MONOGRAPH FINAL part333B Kinray Inc. BACITRACIN 500 [iU]/g 61715-080_9a197e3f-8780-4e8c-912d-9ae8a945fc65 61715-080 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20140315 OTC MONOGRAPH FINAL part347 Preferred Plus (Kinray) DIMETHICONE 125 mg/1 61715-081_42bf42b9-3505-43b5-a06c-47e8824245e3 61715-081 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH NOT FINAL part334 Preferred Plus (Kinray) DOCUSATE SODIUM 100 mg/1 61715-082_2e395d62-913e-43e9-9212-a669da5274b5 61715-082 HUMAN OTC DRUG Anti-Itch Extra Strength Diphenhydramine Hydrochloride and Zinc Acetate CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part348 Preferred Plus (Kinray) DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; 1 mg/g; mg/g 61715-083_5f2492c9-8f17-4b65-ba6e-b969a343167d 61715-083 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20131125 OTC MONOGRAPH FINAL part336 Preferred Plus (Kinray) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 61715-084_097430d7-d5ad-4c9c-a700-cd2b47d0d8f3 61715-084 HUMAN OTC DRUG EZ Nite Sleep Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140212 OTC MONOGRAPH FINAL part338 Preferred Plus (Kinray) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 61715-085_40e6e9ab-a557-4547-9ec8-7c1bc22272b6 61715-085 HUMAN OTC DRUG Nicotine Transdermal System Step 1 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 19991001 ANDA ANDA074612 Preferred Plus (Kinray) NICOTINE 21 mg/24h 61715-086_40e6e9ab-a557-4547-9ec8-7c1bc22272b6 61715-086 HUMAN OTC DRUG Nicotine Transdermal System Step 2 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 19991001 ANDA ANDA074612 Preferred Plus (Kinray) NICOTINE 14 mg/24h 61715-087_40e6e9ab-a557-4547-9ec8-7c1bc22272b6 61715-087 HUMAN OTC DRUG Nicotine Transdermal System Step 3 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 19991001 ANDA ANDA074612 Preferred Plus (Kinray) NICOTINE 7 mg/24h 61715-088_3a6221b2-1135-4065-820d-9abeca87292b 61715-088 HUMAN OTC DRUG Preferred Plus Nicotine Polacrilex Gum, Original Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 19990315 ANDA ANDA074507 Preferred Plus (Kinray) NICOTINE 2 mg/1 61715-089_9dacb085-8749-43cc-9bb9-18629c24f6c9 61715-089 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20140127 ANDA ANDA200536 Preferred Plus (Kinray) RANITIDINE HYDROCHLORIDE 150 mg/1 61715-090_579aeee0-14b3-44b1-a8ae-7b2b38ec1edb 61715-090 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20140127 ANDA ANDA201745 Preferred Plus (Kinray) RANITIDINE HYDROCHLORIDE 75 mg/1 61715-091_98ee5b75-5008-42c8-bc5f-659df6ad9af9 61715-091 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140318 ANDA ANDA077958 Kinray Inc. KETOTIFEN FUMARATE .35 mg/mL 61715-092_5339902d-469a-4fd6-a76f-9d5b141e11b0 61715-092 HUMAN OTC DRUG Preferred Plus Hemorrhoid Glycerin, Petrolatum, Phenylephrine Hydrochloride, Pramoxine Hydrochloride CREAM RECTAL 20140328 OTC MONOGRAPH FINAL part346 Kinray, Inc. GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 144; 150; 2.5; 10 mg/L; mg/L; mg/L; mg/L 61715-093_beb94d25-40a7-4370-83b4-91bd1db24d11 61715-093 HUMAN OTC DRUG Preferred Plus Hemorrhoidal phenylephrine hydrochloride, witch hazel CREAM RECTAL 20140328 OTC MONOGRAPH FINAL part346 Kinray Inc. PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL 2.5; 500 mg/L; mg/L 61715-094_6f12c3bd-4696-4fb4-9cd9-ac21f8164e91 61715-094 HUMAN OTC DRUG Preferred Plus Hemorrhoid witch hazel CLOTH TOPICAL 20140328 OTC MONOGRAPH FINAL part346 Kinray, Inc. WITCH HAZEL 500 mg/L 61715-097_938a7733-c981-488e-a53a-f67bebcea0d0 61715-097 HUMAN OTC DRUG Allergy Relief Eye Drops Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140318 ANDA ANDA077958 Kinray Inc. KETOTIFEN FUMARATE .35 mg/mL 61715-098_a632e4f5-0911-43db-bc9b-c7e07b4e5b5b 61715-098 HUMAN OTC DRUG Naproxen Sodium NAPROXEN SODIUM TABLET, COATED ORAL 20140425 ANDA ANDA079096 Kinray LLC NAPROXEN SODIUM 220 mg/1 61715-099_7abf1fe7-f328-4edf-a7cf-ca83a1c505f7 61715-099 HUMAN OTC DRUG Naproxen Sodium NAPROXEN SODIUM TABLET, COATED ORAL 20140425 ANDA ANDA079096 Kinray LLC NAPROXEN SODIUM 220 mg/1 61715-100_ac9e7959-f8cd-4584-8def-d130916ef68f 61715-100 HUMAN OTC DRUG Acetaminophen PM Rapid Release Acetaminophen and DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20140425 OTC MONOGRAPH FINAL part341 Kinray LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 61715-101_e31ff4e7-8443-439b-bb65-fc5a3a2961de 61715-101 HUMAN OTC DRUG Acetaminophen Rapid Release Acetaminophen TABLET, COATED ORAL 20140425 OTC MONOGRAPH NOT FINAL part343 Kinray LLC ACETAMINOPHEN 500 mg/1 61715-102_147f78df-da88-41e5-a13e-635742ef96de 61715-102 HUMAN OTC DRUG Kinray Vitamin A D Petrolatum OINTMENT TOPICAL 20140310 OTC MONOGRAPH FINAL part347 Kinray Inc. PETROLATUM .76 g/g 61715-103_46ecc0b4-c1d8-4619-86ba-f64791a2601f 61715-103 HUMAN OTC DRUG Preferred Plus Sinus Pseudoephedrine HCl TABLET, FILM COATED ORAL 20140609 OTC MONOGRAPH FINAL part341 Kinray PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 61715-104_e635a878-3352-43a2-86b5-2126ea3da5d6 61715-104 HUMAN OTC DRUG preferred plus arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140922 ANDA ANDA075077 Kinray ACETAMINOPHEN 650 mg/1 61715-105_e91a8a0a-fe82-443c-a8c4-afac601d1aaf 61715-105 HUMAN OTC DRUG Preferred Plus Aller Ease fexofenadine hcl TABLET, FILM COATED ORAL 20140617 ANDA ANDA076447 Kinray FEXOFENADINE HYDROCHLORIDE 180 mg/1 61715-107_ae165253-41ef-463f-ab08-8f8b501264b6 61715-107 HUMAN OTC DRUG Preferred Plus Loperamide Loperamide Hydrochloride SUSPENSION ORAL 20140527 ANDA ANDA091292 Kinray LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 61715-108_95850912-0d07-46e4-88b7-57f2b800d2bd 61715-108 HUMAN OTC DRUG Preferred Plus Loperamide Hydrochloride loperamide HCl SUSPENSION ORAL 20140609 ANDA ANDA091292 Kinray LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 61715-109_535969d5-ad09-41a5-a1f4-073e086c1bfa 61715-109 HUMAN OTC DRUG Preferred Plus Loperamide Hydrochloride Loperamide HCl TABLET, FILM COATED ORAL 20140527 ANDA ANDA075232 Kinray LOPERAMIDE HYDROCHLORIDE 2 mg/1 61715-110_0c4cb490-1ff4-490a-b9f6-ed15845059e5 61715-110 HUMAN OTC DRUG Preferred Plus Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20140609 ANDA ANDA202319 Kinray LANSOPRAZOLE 15 mg/1 61715-111_5d2a6691-0b47-48a4-b3b5-a9411da06762 61715-111 HUMAN OTC DRUG Preferred Plus Severe Nite Time Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SUSPENSION ORAL 20140717 OTC MONOGRAPH FINAL part341 Kinray ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL 61715-112_7b2f3105-0c40-4442-b014-2418767cfd9f 61715-112 HUMAN OTC DRUG Preferred Plus Severe Day Time acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SUSPENSION ORAL 20140717 OTC MONOGRAPH FINAL part341 Kinray ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 61715-113_ac9c79eb-96ba-4086-9f51-53b3f74f0b1a 61715-113 HUMAN OTC DRUG preferred plus cough dm dextromethorphan polistirex SUSPENSION ORAL 20141003 ANDA ANDA091135 Kinray DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 61715-114_6259e9f7-37f8-4d09-a2e5-a0f7fe2ad9bc 61715-114 HUMAN OTC DRUG preferred plus nicotine Nicotine Polacrilex LOZENGE ORAL 20141001 ANDA ANDA203690 Kinray NICOTINE 4 mg/1 61715-115_ba63c60b-9b6d-4a21-b33d-103af846eefd 61715-115 HUMAN OTC DRUG preferred plus nicotine Nicotine Polacrilex LOZENGE ORAL 20140929 ANDA ANDA203690 Kinray NICOTINE 2 mg/1 61715-116_89684270-244a-4af1-be9c-eff7dcaa2dce 61715-116 HUMAN OTC DRUG Sore Throat Phenol SPRAY ORAL 20141031 OTC MONOGRAPH NOT FINAL part356 Preferred Plus (Kinray) PHENOL 1.4 g/100mL 61715-117_08915cb5-b4b2-4aef-a951-26c565a73b9b 61715-117 HUMAN OTC DRUG Sore Throat Phenol SPRAY ORAL 20141031 OTC MONOGRAPH NOT FINAL part356 Preferred Plus (Kinray) PHENOL 1.4 g/100mL 61715-118_475853aa-13aa-45b6-b8eb-4ea88961d2d3 61715-118 HUMAN OTC DRUG Preferred Plus Allergy Relief Loratadine TABLET ORAL 20140922 ANDA ANDA076301 Kinray LORATADINE 10 mg/1 61715-120_12f0b794-c6b3-4729-a76b-fa50071e940e 61715-120 HUMAN OTC DRUG Preferred Plus Severe Cold Cough and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20140915 OTC MONOGRAPH FINAL part341 Kinray ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 61715-121_0d862d78-cfdd-4cae-b3c9-c775f6c9d934 61715-121 HUMAN OTC DRUG preferred plus severe cold cough and flu Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20140922 OTC MONOGRAPH FINAL part341 Kinray ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 61715-122_7ba2bcce-099a-407c-9248-399360c1fe95 61715-122 HUMAN OTC DRUG Preferred Plus All Day Allergy Cetirizine Hydrochloride TABLET ORAL 20140922 ANDA ANDA078336 Kinray CETIRIZINE HYDROCHLORIDE 10 mg/1 61715-125_6a36c9a6-5e22-40f7-bf58-b34be68ac9d6 61715-125 HUMAN OTC DRUG Preferred Plus Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20141013 ANDA ANDA078912 Kinray GUAIFENESIN 600 mg/1 61715-126_941fdff2-f147-4649-a3e0-3ef4ebc622c1 61715-126 HUMAN OTC DRUG Preferred Plus Allergy Relief Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20140922 ANDA ANDA076447 Kinray FEXOFENADINE HYDROCHLORIDE 180 mg/1 61715-129_90609e91-6dea-4279-ac2e-b1f676368083 61715-129 HUMAN OTC DRUG Fiber Therapy Regular Flavor Psyllium Dietary Fiber Supplement GRANULE, FOR SOLUTION ORAL 20140928 OTC MONOGRAPH NOT FINAL part334 Kinray LLC PSYLLIUM HUSK 3.4 g/5.4g 61715-130_90e8a135-fabc-4e02-8857-ff4ad40de1a8 61715-130 HUMAN OTC DRUG Fiber Therapy Orange Flavor Psyllium Dietary Fiber Supplement GRANULE, FOR SOLUTION ORAL 20140928 OTC MONOGRAPH NOT FINAL part334 Kinray LLC PSYLLIUM HUSK 3.4 g/5.4g 61715-131_4fa9508a-e960-4ff8-8439-4689a93d8eb2 61715-131 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide LIQUID ORAL 20141001 OTC MONOGRAPH NOT FINAL part334 Kinray LLC MAGNESIUM HYDROXIDE 400 mg/5mL 61715-140_32b5cca1-00ed-433a-a00d-dde780d7ded0 61715-140 HUMAN OTC DRUG preferred plus congestion relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20141124 ANDA ANDA203200 Kinray IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 61715-144_dcc6ac47-c13b-4acf-8728-f94613a1fb4d 61715-144 HUMAN OTC DRUG Preferred Plus Cold and Flu Night Time Acetaminophen, diphenhydramine HCl, phenylephrine HCl TABLET, FILM COATED ORAL 20141203 OTC MONOGRAPH FINAL part341 Kinray ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 61715-145_8d5d7426-a6bd-4b58-84f6-c59e5b31f764 61715-145 HUMAN OTC DRUG Preferred Plus Mucus Relief Cold and Sinus acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20141204 OTC MONOGRAPH FINAL part341 Kinray ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 61715-146_133176f5-67ec-4f43-a86e-6812a3dc983a 61715-146 HUMAN OTC DRUG preferred plus mucus relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20141223 OTC MONOGRAPH FINAL part341 Kinray ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 61715-147_d0d09883-4cdf-4265-923c-10a7a968b448 61715-147 HUMAN OTC DRUG preferred plus severe cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20141203 OTC MONOGRAPH FINAL part341 Kinray ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 61715-148_fed5f9fa-4f12-4291-92dc-19f50cec82b1 61715-148 HUMAN OTC DRUG Preferred Plus Sinus Relief Acetaminophen, guaifenesin, phenylephrine HCl CAPSULE, COATED ORAL 20141217 OTC MONOGRAPH FINAL part341 Kinray ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 61715-150_e835dda7-e5a6-4a65-9b00-acb51df5d617 61715-150 HUMAN OTC DRUG Preferred Plus ClearLax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20141120 ANDA ANDA090685 Kinray POLYETHYLENE GLYCOL 3350 17 g/17g 61715-151_fc90d5ea-5c1a-44e0-a836-dd3dccf94d80 61715-151 HUMAN OTC DRUG Preferred Plus Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20141020 NDA NDA022032 Kinray OMEPRAZOLE 20 mg/1 61715-152_f5ce09db-88d5-47b0-a552-1f6310955e34 61715-152 HUMAN OTC DRUG Preferred Plus Nasal oxymetazoline hydrochloride SPRAY NASAL 20141124 OTC MONOGRAPH FINAL part341 Kinray OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 61715-153_e9be22b7-5925-443c-9572-813449cf49f5 61715-153 HUMAN OTC DRUG Preferred Plus Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20141124 OTC MONOGRAPH FINAL part341 Kinray OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 61715-800_4d388035-b237-4710-9020-a0ee5bdac78c 61715-800 HUMAN OTC DRUG Preferred Plus Sinus Relief Day Tiime Night Time Acetaminophen, guaifenesin, diphenhydramine HCl, phenylephrine HCl KIT 20141203 OTC MONOGRAPH FINAL part341 Kinray 61722-001_fc029a79-0558-4f7a-aeda-4799982154eb 61722-001 HUMAN OTC DRUG flormar BB Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 01 Light OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-002_23ffedd0-2407-4cca-8aee-d57299b3035b 61722-002 HUMAN OTC DRUG flormar BB Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 02 Light Medium OCTINOXATE CREAM TOPICAL 20140612 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-003_747dbae5-afe0-4f38-81a5-3d25c529be1d 61722-003 HUMAN OTC DRUG flormar BB Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 03 Dark Medium OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-004_89f48832-9646-4533-9f46-1412929acf75 61722-004 HUMAN OTC DRUG flormar BB Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 04 Medium Beige OCTINOXATE CREAM TOPICAL 20140612 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-005_5f038453-8385-4aa0-9b54-8c68f89f0791 61722-005 HUMAN OTC DRUG flormar BB Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 05 Neutral Beige OCTINOXATE CREAM TOPICAL 20140612 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-006_bda2e7f6-7401-4ed9-be77-8af5b8624325 61722-006 HUMAN OTC DRUG flormar BB Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 06 Warm Beige OCTINOXATE CREAM TOPICAL 20140612 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-020_d1e3fc2e-b59c-470f-8d2e-6a2f440f887c 61722-020 HUMAN OTC DRUG flormar ADVICE Skin Geometry Day Sunscreen Broad Spectrum SPF 15 AVOBENZONE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 15; 40; 20 mg/mL; mg/mL; mg/mL 61722-021_9c63fc03-b55d-4ebf-bad6-11506e0d5598 61722-021 HUMAN OTC DRUG flormar ADVICE Skin Geometry Purely Moisturizing Day Sunscreen Broad Spectrum SPF 15 Dry and Sensitive Skin AVOBENZONE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20140613 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 15; 40; 20 mg/mL; mg/mL; mg/mL 61722-022_ce1e6dfe-df49-4034-9f9c-d9a19f368dd5 61722-022 HUMAN OTC DRUG flormar ADVICE Skin Geometry Purely Moisturizing Day Sunscreen Broad Spectrum SPF 15 Normal and Combination Skin AVOBENZONE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 15; 40; 20 mg/mL; mg/mL; mg/mL 61722-023_a68834d0-cb57-4552-a7ea-04ca4cbcb536 61722-023 HUMAN OTC DRUG flormar REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10 OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-040_6abf33fc-b36d-4026-8aa5-24325a40a321 61722-040 HUMAN OTC DRUG flormar Concealer Sunscreen Broad Spectrum SPF 20 LC01 PURE BEIGE OCTINOXATE CREAM TOPICAL 20140618 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-041_31ba0c66-5ed5-4c54-9d6a-e805187c9e0a 61722-041 HUMAN OTC DRUG flormar Concealer Sunscreen Broad Spectrum SPF 20 LC03 SOFT HONEY OCTINOXATE CREAM TOPICAL 20140618 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-042_d3df7524-d722-4290-b61e-0fa2b1dc8bb3 61722-042 HUMAN OTC DRUG flormar Concealer Sunscreen Broad Spectrum SPF 20 LC05 CAPPUCCINO OCTINOXATE CREAM TOPICAL 20140618 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-043_694b95e8-0924-48ce-ac71-dedd99f47aba 61722-043 HUMAN OTC DRUG flormar Concealer Sunscreen Broad Spectrum SPF 20 LC07 NATURAL BEIGE OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-060_d66f5bf1-377f-4704-819f-3c9a854b55ee 61722-060 HUMAN OTC DRUG flormar Foundation Sunscreen Broad Spectrum SPF 20 LF01 PORCELAIN OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-061_5b461d91-a723-4313-b491-0f9db21f6354 61722-061 HUMAN OTC DRUG flormar Foundation Sunscreen Broad Spectrum SPF 20 LF04 SOFT IVORY OCTINOXATE CREAM TOPICAL 20140618 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-062_18708174-8bdf-4729-b659-f5a03f236398 61722-062 HUMAN OTC DRUG flormar Foundation Sunscreen Broad Spectrum SPF 20 LF07 IVORY OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-063_f41abb8e-d89c-413c-b888-dd997e019876 61722-063 HUMAN OTC DRUG flormar Foundation Sunscreen Broad Spectrum SPF 20 LF10 SAND BEIGE OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-064_60efbd8f-6d04-4ffe-9f40-1d54a7388f1f 61722-064 HUMAN OTC DRUG flormar Foundation Sunscreen Broad Spectrum SPF 20 LF13 GOLDEN BEIGE OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-065_35c5b90b-6d16-4b18-9213-ce4a9e39fe43 61722-065 HUMAN OTC DRUG flormar Foundation Sunscreen Broad Spectrum SPF 20 LF16 NATURAL BEIGE OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-066_ea34c4d0-0166-4edd-b9b9-90ca59acd7ec 61722-066 HUMAN OTC DRUG flormar Foundation Sunscreen Broad Spectrum SPF 20 LF19 BEIGE OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-067_848be030-f970-47e6-bb92-29e0f9a23568 61722-067 HUMAN OTC DRUG flormar Foundation Sunscreen Broad Spectrum SPF 20 LF22 PURE BEIGE OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-080_55387018-2218-4aaa-8606-528b72a34bf8 61722-080 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 101 Pastelle OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL 61722-081_b755b2a7-8980-4fa3-b1c3-d44256441486 61722-081 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 102 Soft Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL 61722-082_332e6e80-7949-470a-a4ad-c75ec539fe9f 61722-082 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 103 Creamy Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL 61722-083_e9d8db12-4cdf-48f3-aa43-5504199af038 61722-083 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 104 Vanille Eclat OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL 61722-084_8d64307c-71c7-4bc8-8f03-b3b2fce2237a 61722-084 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 105 Porcelain Ivory OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL 61722-085_42730151-9512-43ca-b0e2-073cf2e06c2c 61722-085 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 106 Classic Ivory OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL 61722-086_efafe4ce-239d-4a17-909c-cd663221d4a8 61722-086 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 107 Natural Ivory OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL 61722-087_83b37afa-c87d-499f-a0d3-a0a456c4ff20 61722-087 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 108 Honey OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL 61722-088_710eeb74-efd3-4519-83af-8ad945328bce 61722-088 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 113 Medium Beige OCTINOXATE CREAM TOPICAL 20140721 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL 61722-089_df029a7a-9ec7-4531-a007-8be706f85f70 61722-089 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 114 Light Beige OCTINOXATE CREAM TOPICAL 20140721 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL 61722-090_cf5373b4-8492-4246-8de0-3daa331daf57 61722-090 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 116 Deep Tan OCTINOXATE CREAM TOPICAL 20140721 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL 61722-091_1afdbf5e-7ed4-48ac-bb1d-b78c14b4403b 61722-091 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 119 Cocoa OCTINOXATE CREAM TOPICAL 20140721 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL 61722-140_21987bc3-3f60-4477-b547-c47deb88e8d1 61722-140 HUMAN OTC DRUG flormar CC Magical Color Effect Color Correcting Cream Sunscreen Broad Spectrum SPF 15 CC02 OCTINOXATE CREAM TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-141_8b0aa06b-1ecf-4b3d-8f3c-5eb3ea6d9cb5 61722-141 HUMAN OTC DRUG flormar CC Magical Color Effect Color Correcting Cream Sunscreen Broad Spectrum SPF 15 CC03 OCTINOXATE CREAM TOPICAL 20140708 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-142_28ccd0b8-f7b0-4003-8a3a-871f58869e20 61722-142 HUMAN OTC DRUG flormar CC Magical Color Effect Color Correcting Cream Sunscreen Broad Spectrum SPF 15 CC04 OCTINOXATE CREAM TOPICAL 20140708 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-160_ab4a0b8c-14e2-4d27-a98b-9eac5d7609e8 61722-160 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP01 Rose OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/g 61722-161_48f8906a-89b5-4311-b1e6-de631c1a6d2e 61722-161 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP04 Rich Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g 61722-162_c6ab5788-fd28-451e-9982-5e458f9981ee 61722-162 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP07 Nude Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g 61722-163_3d989e0e-c335-4fd5-9928-006ebdc1b35c 61722-163 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP10 Classic Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g 61722-164_2ffd505c-b2e2-4251-b208-49e1a6d7d270 61722-164 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP13 Nude Ivory OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g 61722-165_18d9d32f-99df-4526-939a-b45d258c5d84 61722-165 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP16 Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g 61722-166_45a9abd6-6827-4bb1-9d76-603e3a4ec3d1 61722-166 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP19 Natural Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g 61722-167_5cf18ee0-dff3-4840-ad11-a12f84b8eaab 61722-167 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP21 Soft Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g 61722-168_0fde1ae4-7599-4b01-a227-d2abbd360daa 61722-168 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP24 Medium OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g 61722-169_5aff246f-2eb6-4f04-bdfe-63c83e8c688e 61722-169 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP27 Capuccino OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g 61722-170_bf092282-40d3-44b3-8031-060a000a6928 61722-170 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP33 Chocolate OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g 61722-171_078daff4-71ec-4fa2-84d8-c95411d7a43a 61722-171 HUMAN OTC DRUG FLORMAR REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP30 Caramel OCTINOXATE POWDER TOPICAL 20141024 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/g 61722-180_f259bdfe-e15c-49cf-a1ae-9c323b1e99fa 61722-180 HUMAN OTC DRUG flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST01 Light Pink OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-181_9f2b234c-9473-4eb8-9bb7-f5e96b87e3c4 61722-181 HUMAN OTC DRUG flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST02 Medium Pink OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-182_90df5b6d-400b-4ad0-b520-8372371a6629 61722-182 HUMAN OTC DRUG flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST03 Natural Pink OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-183_33e45bd6-c428-4bf4-a209-e2405b91eb20 61722-183 HUMAN OTC DRUG flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST04 Medium Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-184_df4abccc-6fee-457c-8217-af0636a4c074 61722-184 HUMAN OTC DRUG flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST06 Honey OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-185_b837d035-d336-474c-a4b0-094bab389439 61722-185 HUMAN OTC DRUG flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST07 Caramel OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-186_e5b8dcea-a645-4f7b-aa04-43cbc0881636 61722-186 HUMAN OTC DRUG flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST08 Bronze Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-187_388b43b7-e476-43b3-b870-c7a8372f5dfe 61722-187 HUMAN OTC DRUG flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST05 Warm Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-200_ca902bf8-9323-4d49-946c-0c35f4b1f211 61722-200 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF01 Rose OCTINOXATE CREAM TOPICAL 20140704 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-201_a6fa3d2e-9d0c-4734-a901-a6aa65d43166 61722-201 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF04 Rich Beige OCTINOXATE CREAM TOPICAL 20140704 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-202_18303505-0ce3-4ad2-8652-21a1fe7430c2 61722-202 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF07 Nude Beige OCTINOXATE CREAM TOPICAL 20140704 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-203_a966ff61-d47d-4297-8047-590a61088364 61722-203 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF10 Classic Beige OCTINOXATE CREAM TOPICAL 20140704 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-204_985457fe-5f55-4330-9d1c-1dcd95d5f82b 61722-204 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF13 Nude Ivory OCTINOXATE CREAM TOPICAL 20140704 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-205_c03fabb7-d963-4303-b88d-b88d510169f3 61722-205 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF16 Beige OCTINOXATE CREAM TOPICAL 20140704 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-206_22709943-5745-4694-84ca-82a5e62ea7db 61722-206 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF19 Natural Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-207_84fc7edc-9ee9-4145-91fd-50fc9d78ae03 61722-207 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF21 Soft Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-208_7f8f93c2-9a1a-4873-8527-dcf3c0e420b1 61722-208 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF24 Medium OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-209_87f93ad6-c4c1-4bdb-8969-b76d0551f28a 61722-209 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF27 Capuccino OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-210_28592e5d-8166-4d59-8d84-d938b1480a70 61722-210 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF30 Caramel OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-211_a4e31faa-358a-475f-a648-f248d9f9c5e4 61722-211 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF33 Chocolate OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL 61722-220_6d2e3445-4ad0-45bc-b493-55df41c00856 61722-220 HUMAN OTC DRUG FLORMAR RADIANT PINK SKIN HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 15 AVOBENZONE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20141107 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 30; 75; 10 mg/mL; mg/mL; 1/mL 61722-230_699c37d8-0c91-4074-91f2-f7c549f300d1 61722-230 HUMAN OTC DRUG flormar Delicious Lipstick Stylo Sunscreen Broad Spectrum SPF 15 DS03 Doll Photomontage TITANIUM DIOXIDE STICK TOPICAL 20141217 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. TITANIUM DIOXIDE 20 mg/g 61722-250_e8cc1b17-b380-4d3e-be17-4a95b82eefd0 61722-250 HUMAN OTC DRUG Flormar Lip Moisturizer Apple Sunscreen Stick Broad Spectrum SPF 15 OCTINOXATE LIPSTICK TOPICAL 20141223 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi Ve Ticaret A.S. OCTINOXATE 69 mg/g 61722-251_a9a5d597-ee3b-4809-bca7-0b8904ea18dd 61722-251 HUMAN OTC DRUG Flormar Lip Moisturizer Water Melon Sunscreen Stick Broad Spectrum SPF 15 OCTINOXATE LIPSTICK TOPICAL 20141223 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi Ve Ticaret A.S. OCTINOXATE 68 mg/g 61727-050_b1e5e8ac-6a7a-4290-8a1d-23bbeb61646f 61727-050 HUMAN OTC DRUG Allergy Relief Now Chemical Sensitivity Remedy Chemical Sensitivity Remedy SPRAY ORAL 20140324 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARSENIC TRIOXIDE; CALCIUM SULFIDE; EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; HISTAMINE; NUTMEG; PHENOL; SODIUM CARBONATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFURIC ACID 10; 10; 6; 6; 12; 6; 10; 10; 6; 6; 10 [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X] 61727-051_f367d79c-2091-4191-939d-0da10e014c39 61727-051 HUMAN OTC DRUG Allergy Relief Now Food Sensitivity Remedy Food Sensitivity Remedy SPRAY ORAL 20140324 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ACETALDEHYDE; ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; COUMARIN; GALLIC ACID MONOHYDRATE; HYDRANGEA ARBORESCENS ROOT; INDOLE; KEROSENE; RUTIN; SACCHAROMYCES CEREVISIAE; SILVER NITRATE 12; 12; 6; 12; 6; 6; 12; 6; 12; 12; 3 [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X] 61727-052_f2a6f972-6d51-47b0-8b11-5c72eaf04d3c 61727-052 HUMAN OTC DRUG Allergy Relief Now Inhaled Allergy Remedy Inhaled Allergy Remedy SPRAY ORAL 20140324 UNAPPROVED HOMEOPATHIC Homeocare Laboratories AMBROSIA ARTEMISIIFOLIA; ARUNDO PLINIANA ROOT; BLACK MUSTARD SEED; EUPHRASIA STRICTA; HISTAMINE; NAPHTHALENE; ONION; SCHOENOCAULON OFFICINALE SEED; URTICA URENS; WYETHIA HELENIOIDES ROOT 4; 6; 6; 3; 12; 5; 5; 7; 6; 3 [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X] 61727-053_8b09cba8-0e2d-4d42-a8f4-9833bf5c9433 61727-053 HUMAN OTC DRUG Allergy Relief Now Hay Fever Remedy Hay Fever Remedy SPRAY ORAL 20140325 UNAPPROVED HOMEOPATHIC Homeocare Laboratories AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIIODIDE; BROMINE; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; ONION; SANGUINARIA CANADENSIS ROOT; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE 6; 10; 10; 6; 6; 12; 6; 6; 6; 10 [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X] 61727-111_1687a99a-44a5-4df1-8a64-dd3919c18d2d 61727-111 HUMAN OTC DRUG Arnica Relief Arnica Montana 30C TABLET ORAL 20120706 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARNICA MONTANA 30 [hp_C]/1 61727-112_fdffe55d-595f-4082-9047-b1adb9b82188 61727-112 HUMAN OTC DRUG Arnica Relief ARNICA MONTANA CREAM TOPICAL 20120410 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARNICA MONTANA 1 [hp_X]/56.7g 61727-301_0c28bbde-e8f9-4de4-bdef-287567291267 61727-301 HUMAN OTC DRUG Allergy Relief ONION,APIS MELLIFERA,DROSERA ROTUNDIFOLIA,EUPHRASIA STRICTA,URTICA URENS. PELLET SUBLINGUAL 20120608 UNAPPROVED HOMEOPATHIC Homeocare Laboratories APIS MELLIFERA; DROSERA ROTUNDIFOLIA; EUPHRASIA STRICTA; ONION; URTICA URENS 8; 8; 8; 8; 8 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 61727-302_46edf9c8-f4cb-4925-91e1-5278941c8dc0 61727-302 HUMAN OTC DRUG Arthritis Relief ARNICA MONTANA, BRYONIA ALBA, CHAMOMILLA,HYPERICUM PERFORATUM, KALMIA LATIFOLIA LEAF,KALMIA LATIFOLIA LEAF PELLET SUBLINGUAL 20120731 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARNICA MONTANA; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; MATRICARIA RECUTITA; TOXICODENDRON PUBESCENS LEAF 18; 8; 8; 8; 8; 8 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 61727-303_6209a925-37e3-412f-8f4b-bdce4b250624 61727-303 HUMAN OTC DRUG Cold and Flu Relief ACONITUM NAPELLUS,ONION,ARNICA MONTANA,ATROPA BELLADONNA,SOLANUM DULCAMARA TOP,EUPATORIUM CANNABINUM,GELSEMIUM SEMPERVIRENS ROOT. PELLET SUBLINGUAL 20120705 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; EUPATORIUM CANNABINUM; GELSEMIUM SEMPERVIRENS ROOT; ONION; SOLANUM DULCAMARA TOP 14; 8; 8; 8; 18; 8; 8 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 61727-304_3b2b32d5-ed52-4b98-b508-5ddb87de0ce8 61727-304 HUMAN OTC DRUG Constipation Relief ALUMINUM OXIDE,BRYONIA ALBA ROOT,SODIUM CHLORIDE,GRAPHITE,SILICON DIOXIDE. PELLET SUBLINGUAL 20120705 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ALUMINUM OXIDE; BRYONIA ALBA ROOT; GRAPHITE; SILICON DIOXIDE; SODIUM CHLORIDE 10; 8; 10; 10; 8 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 61727-305_45528033-480c-4dc5-8fcd-793257fd368c 61727-305 HUMAN OTC DRUG Headache Relief ATROPA BELLADONNA,CYCLAMEN PURPURASCENS TUBER,COFFEA ARABICA SEED, ROASTED,IRIS VERSICOLOR ROOT,STRYCHNOS NUX-VOMICA SEED,SANGUINARIA CANADENSIS ROOT,SPIGELIA MARILANDICA ROOT,VIBURNUM OPULUS BARK. PELLET SUBLINGUAL 20120720 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ATROPA BELLADONNA; COFFEA ARABICA SEED, ROASTED; CYCLAMEN PURPURASCENS TUBER; IRIS VERSICOLOR ROOT; SANGUINARIA CANADENSIS ROOT; SPIGELIA MARILANDICA ROOT; STRYCHNOS NUX-VOMICA SEED; VIBURNUM OPULUS BARK 8; 4; 8; 8; 8; 8; 9; 4 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 61727-306_350fda2c-a050-43dd-8f9d-2ab3722f1e7c 61727-306 HUMAN OTC DRUG Hemorrhoids Relief HORSE CHESTNUT,ALOE,HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,NITRIC ACID,PAEONIA OFFICINALIS ROOT,SEPIA OFFICINALIS JUICE. PELLET SUBLINGUAL 20120720 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ALOE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; NITRIC ACID; PAEONIA OFFICINALIS ROOT; SEPIA OFFICINALIS JUICE 8; 8; 8; 8; 8; 8 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 61727-307_8379942b-ea57-463a-8f4e-79581bbde648 61727-307 HUMAN OTC DRUG Insomnia Relief Insomnia Relief PELLET SUBLINGUAL 20120720 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; DATURA STRAMONIUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED 14; 3; 8; 8; 8; 8 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 61727-308_7dd4267e-8dc3-4520-9adc-e02498032b35 61727-308 HUMAN OTC DRUG Menopause Relief BARIUM CARBONATE,ATROPA BELLADONNA,BLACK COHOSH,NITROGLYCERIN,LACHESIS MUTA VENOM,SILICON DIOXIDE. PELLET SUBLINGUAL 20120723 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ATROPA BELLADONNA; BARIUM CARBONATE; BLACK COHOSH; LACHESIS MUTA VENOM; NITROGLYCERIN; SILICON DIOXIDE 8; 10; 8; 10; 8; 10 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 61727-309_a5fa8f1c-7ba8-4509-bf48-3d3c914ccb0a 61727-309 HUMAN OTC DRUG Muscular Pain Relief ARNICA MONTANA,COPPER,POTASSIUM PHOSPHATE, DIBASIC,LACTIC ACID, DL-,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE. PELLET SUBLINGUAL 20120723 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARNICA MONTANA; COPPER; LACTIC ACID, DL-; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM PHOSPHATE, DIBASIC 18; 10; 8; 10; 8 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 61727-310_585f869e-ebd3-478a-a393-98067d272167 61727-310 HUMAN OTC DRUG PMS Relief COPPER,ESTRONE,HISTAMINE DIHYDROCHLORIDE,MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE,SODIUM SULFATE. PELLET SUBLINGUAL 20120723 UNAPPROVED HOMEOPATHIC Homeocare Laboratories COPPER; ESTRONE; HISTAMINE DIHYDROCHLORIDE; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; SODIUM SULFATE 10; 18; 8; 10; 8 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 61727-311_2807b07d-94e6-4718-9ce5-afcd4cfc3d81 61727-311 HUMAN OTC DRUG Sore Throat Relief ACONITUM NAPELLUS,APIS MELLIFERA,ATROPA BELLADONNA,SOLANUM DULCAMARA TOP,MERCURIUS SOLUBILIS,PHYTOLACCA AMERICANA ROOT. PELLET SUBLINGUAL 20120724 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ACONITUM NAPELLUS; APIS MELLIFERA; ATROPA BELLADONNA; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; SOLANUM DULCAMARA TOP 10; 10; 10; 10; 8; 8 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 61727-312_956f35a8-4978-47ce-9790-c329fa69a90c 61727-312 HUMAN OTC DRUG Stress Relief SILVER NITRATE,MATRICARIA RECUTITA,COFFEA ARABICA SEED, ROASTED,STRYCHNOS IGNATII SEED,STRYCHNOS NUX-VOMICA SEED,PHOSPHORIC ACID,DATURA STRAMONIUM. PELLET SUBLINGUAL 20120803 UNAPPROVED HOMEOPATHIC Homeocare Laboratories COFFEA ARABICA SEED, ROASTED; DATURA STRAMONIUM; MATRICARIA RECUTITA; PHOSPHORIC ACID; SILVER NITRATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED 8; 10; 8; 8; 10; 10; 10 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 61727-313_71116e45-db57-4870-9f33-2c50fb9ee2e5 61727-313 HUMAN OTC DRUG Vigoril for Men SILVER NITRATE,AVENA SATIVA FLOWERING TOP,TURNERA DIFFUSA LEAFY TWIG,LYCOPODIUM CLAVATUM SPORE,PHOSPHORIC ACID, SELENIUM. TABLET ORAL 20120724 UNAPPROVED HOMEOPATHIC Homeocare Laboratories AVENA SATIVA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SELENIUM; SILVER NITRATE; TURNERA DIFFUSA LEAFY TWIG 5; 5; 5; 5; 5; 5 [hp_C]/901; [hp_C]/901; [hp_C]/901; [hp_C]/901; [hp_C]/901; [hp_C]/901 61727-316_0e9bebb6-a14e-4ab4-9a40-6528e63f4e61 61727-316 HUMAN OTC DRUG Vigoril Plus SILVER NITRATE,AVENA SATIVA FLOWERING TOP,POTASSIUM PHOSPHATE, DIBASIC,STRYCHNOS NUX-VOMICA SEED,PHOSPHORIC ACID,SILICON DIOXIDE,TURNERA DIFFUSA LEAFY TWIG. PELLET SUBLINGUAL 20120814 UNAPPROVED HOMEOPATHIC Homeocare Laboratories AVENA SATIVA FLOWERING TOP; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SILICON DIOXIDE; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; TURNERA DIFFUSA LEAFY TWIG 9; 7; 7; 5; 5; 9; 12 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 61727-317_69ae4c13-0e24-4506-8484-9371dda9b515 61727-317 HUMAN OTC DRUG Vigofem Plus for Women CHASTE TREE,BARIUM CARBONATE,CONIUM MACULATUM FLOWERING TOP,PHOSPHORIC ACID,SEPIA OFFICINALIS JUICE. PELLET SUBLINGUAL 20120724 UNAPPROVED HOMEOPATHIC Homeocare Laboratories BARIUM CARBONATE; CHASTE TREE; CONIUM MACULATUM FLOWERING TOP; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE 7; 12; 4; 9; 9 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 61727-318_201444bd-5fe2-4bea-8698-99722fc8399e 61727-318 HUMAN OTC DRUG Blatrol Bladder Relief LYTTA VESICATORIA,CAUSTICUM,EQUISETUM HYEMALE,CHONDRODENDRON TOMENTOSUM ROOT,SAW PALMETTO,SEPIA OFFICINALIS JUICE, DELPHINIUM STAPHISAGRIA SEED, PELLET SUBLINGUAL 20120618 UNAPPROVED HOMEOPATHIC Homeocare Laboratories CAUSTICUM; CHONDRODENDRON TOMENTOSUM ROOT; DELPHINIUM STAPHISAGRIA SEED; EQUISETUM HYEMALE; LYTTA VESICATORIA; SAW PALMETTO; SEPIA OFFICINALIS JUICE 5; 5; 5; 6; 6; 5; 5 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 61727-319_b859176a-c148-467e-bcb8-9fe27826bf50 61727-319 HUMAN OTC DRUG Hair-X Hair Loss Relief CADMIUM SULFATE,GRAPHITE,PHOSPHORIC ACID,SILICON DIOXIDE,SELENIUM,THALLIUM,USTILAGO MAYDIS. PELLET SUBLINGUAL 20120710 UNAPPROVED HOMEOPATHIC Homeocare Laboratories CADMIUM SULFATE; GRAPHITE; PHOSPHORIC ACID; SELENIUM; SILICON DIOXIDE; THALLIUM; USTILAGO MAYDIS 12; 4; 5; 5; 4; 7; 9 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 61727-321_3b9f0c5f-e813-4942-ab46-9749a2b83052 61727-321 HUMAN OTC DRUG Fibromyalgia Relief ARNICA MONTANA,LACTIC ACID,STRYCHNOS NUX-VOMICA SEED,POTASSIUM PHOSPHATE, DIBASIC,CUPRIC ARSENITE. PELLET SUBLINGUAL 20120709 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARNICA MONTANA; CUPRIC ARSENITE; LACTIC ACID; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED 18; 10; 10; 10; 10; 10 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 61727-322_b0d4be64-dbba-4778-9318-92e651e6c655 61727-322 HUMAN OTC DRUG IBS Irritable Bowel Syndrome Relief CITRULLUS COLOCYNTHIS FRUIT PULP,GRATIOLA OFFICINALIS,LYCOPODIUM CLAVATUM SPORE,SODIUM CARBONATE,STRYCHNOS NUX-VOMICA SEED,SULFUR,TAXUS BACCATA FRUIT,PODOPHYLLUM. PELLET SUBLINGUAL 20120720 UNAPPROVED HOMEOPATHIC Homeocare Laboratories CITRULLUS COLOCYNTHIS FRUIT PULP; GRATIOLA OFFICINALIS; LYCOPODIUM CLAVATUM SPORE; PODOPHYLLUM; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SULFUR; TAXUS BACCATA FRUIT 7; 5; 5; 4; 5; 9; 5; 5 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 61727-323_cf7161f7-18e2-41ac-b86a-cb31ab0ec7b6 61727-323 HUMAN OTC DRUG Sciatica Relief ARNICA MONTANA FLOWER,BRYONIA ALBA WHOLE,MATRICARIA RECUTITA,PSEUDOGNAPHALIUM LUTEOALBUM LEAF,KALMIA LATIFOLIA LEAF,TOXICODENDRON PUBESCENS LEAF,VISCUM ALBUM LEAF. PELLET SUBLINGUAL 20120723 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARNICA MONTANA FLOWER; BRYONIA ALBA WHOLE; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; MATRICARIA RECUTITA; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM LEAF 9; 4; 4; 4; 200; 5; 4; 6 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 61727-324_3bf28b6a-eab6-4ef1-84a9-ce36ae275dc4 61727-324 HUMAN OTC DRUG EZ-Quit ANTIMONY TRISULFIDE,DIEFFENBACHIA SEGUINE,STRYCHNOS IGNATII SEED,LOBELIA INFLATA,TOBACCO LEAF. PELLET SUBLINGUAL 20120801 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ANTIMONY TRISULFIDE; DIEFFENBACHIA SEGUINE; LOBELIA INFLATA; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 5; 5; 5; 5; 5; 9 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 61727-325_86ebd615-47ae-45f7-a26c-fae47d1487a7 61727-325 HUMAN OTC DRUG Ez-Slim ANTIMONY TRISULFIDE,SEMECARPUS ANACARDIUM JUICE,FUCUS VESICULOSUS,BOS TAURUS HYPOTHALAMUS,SODIUM SULFATE,PHYTOLACCA AMERICANA ROOT,THYROID, UNSPECIFIED. PELLET SUBLINGUAL 20120706 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ANTIMONY TRISULFIDE; BOS TAURUS HYPOTHALAMUS; FUCUS VESICULOSUS; PHYTOLACCA AMERICANA ROOT; SEMECARPUS ANACARDIUM JUICE; SODIUM SULFATE; THYROID, UNSPECIFIED 5; 18; 1; 2; 5; 9; 8 [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g 61727-326_cdd559f3-03fa-4a74-8551-175f43b4e153 61727-326 HUMAN OTC DRUG Eczema Relief ANTIMONY TRISULFIDE,APIS MELLIFERA,ARSENIC TRIOXIDE,ATROPA BELLADONNA,GRAPHITE,ARCTIUM LAPPA FRUIT,KEROSENE,SOLIDAGO CANADENSIS WHOLE,VIOLA TRICOLOR. PELLET SUBLINGUAL 20120706 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ANTIMONY TRISULFIDE; APIS MELLIFERA; ARCTIUM LAPPA FRUIT; ARSENIC TRIOXIDE; ATROPA BELLADONNA; GRAPHITE; KEROSENE; SOLIDAGO CANADENSIS WHOLE; VIOLA TRICOLOR 5; 5; 4; 5; 5; 5; 5; 4; 4 [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g 61727-327_ab079d8d-5b69-428c-8f24-ac286374c510 61727-327 HUMAN OTC DRUG HBP Relief BARIUM CARBONATE,ATROPA BELLADONNA,NITROGLYCERIN,LYCOPUS VIRGINICUS,STRYCHNOS NUX-VOMICA SEED,LEAD. PELLET SUBLINGUAL 20120710 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ATROPA BELLADONNA; BARIUM CARBONATE; LEAD; LYCOPUS VIRGINICUS; NITROGLYCERIN; STRYCHNOS NUX-VOMICA SEED 4; 4; 4; 6; 4; 4 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 61727-328_8ed01c5a-b6b7-4057-a04a-72378523a813 61727-328 HUMAN OTC DRUG Weight Gloss SEMECARPUS ANACARDIUM JUICE,ANTIMONY TRISULFIDE,STRYCHNOS IGNATII SEED,BOS TAURUS HYPOTHALAMUS,SULFUR,COCOA. LIPSTICK TOPICAL 20120814 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ANTIMONY TRISULFIDE; BOS TAURUS HYPOTHALAMUS; COCOA; SEMECARPUS ANACARDIUM JUICE; STRYCHNOS IGNATII SEED; SULFUR 5; 5; 5; 5; 5; 5 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL 61727-329_3d665f84-8d08-45c4-9845-8113c2a2121b 61727-329 HUMAN OTC DRUG Cholestop ARCTIUM LAPPA WHOLE,BERBERIS VULGARIS ROOT BARK,SILYBUM MARIANUM SEED,CHELIDONIUM MAJUS,CHOLESTEROL,CHRYSANTHELLUM INDICUM SUBSP. AFROAMERICANUM,SOLIDAGO CANADENSIS FLOWERING TOP,TARAXACUM PALUSTRE ROOT. PELLET SUBLINGUAL 20120618 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARCTIUM LAPPA WHOLE; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; CHOLESTEROL; CHRYSANTHELLUM INDICUM SUBSP. AFROAMERICANUM; SILYBUM MARIANUM SEED; SOLIDAGO CANADENSIS FLOWERING TOP; TARAXACUM PALUSTRE ROOT 4; 4; 4; 9; 4; 4; 4; 4 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 61727-330_8fdf949d-a947-403a-9554-786f87898059 61727-330 HUMAN OTC DRUG Hangover Relief ASAFETIDA,CAPSICUM,POTASSIUM DICHROMATE,COLA NUT,LACHESIS MUTA VENOM,STRYCHNOS NUX-VOMICA SEED,RANUNCULUS BULBOSUS,SULFURIC ACID,ZINC. PELLET SUBLINGUAL 20111123 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ASAFETIDA; CAPSICUM; COLA NUT; LACHESIS MUTA VENOM; POTASSIUM DICHROMATE; RANUNCULUS BULBOSUS; STRYCHNOS NUX-VOMICA SEED; SULFURIC ACID; ZINC 5; 5; 5; 5; 5; 7; 5; 5; 5 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 61727-332_58146f7f-009a-4109-a4be-c3d686160954 61727-332 HUMAN OTC DRUG Anxiety Relief ACONITUM NAPELLUS PELLET ORAL 20111122 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ACONITUM NAPELLUS; ARSENIC TRIOXIDE; COFFEE BEAN; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA RECUTITA; SILVER CATION; STRYCHNOS IGNATII SEED 30; 30; 9; 9; 12; 12; 9 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 61727-333_417ecbf6-fc40-4dfe-8e05-c3c72a8def31 61727-333 HUMAN OTC DRUG Carpal Tunnel Relief APIS MELLIFERA, ARNICA MONTANA,CAULOPHYLLUM ROBUSTUM ROOT,RUTA GRAVEOLENS FLOWERING TOP,VIOLA ODORATA. PELLET SUBLINGUAL 20111123 UNAPPROVED HOMEOPATHIC Homeocare Laboratories APIS MELLIFERA; ARNICA MONTANA; CAULOPHYLLUM ROBUSTUM ROOT; RUTA GRAVEOLENS FLOWERING TOP; VIOLA ODORATA 4; 4; 4; 4; 4 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 61727-334_adb334ed-faa4-4c43-9e04-bd258d371a69 61727-334 HUMAN OTC DRUG Leg Cramps Relief CUPRIC ARSENITE,COPPER,POTASSIUM PHOSPHATE, DIBASIC,LACTIC ACID, L-,MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE. PELLET SUBLINGUAL 20111123 UNAPPROVED HOMEOPATHIC Homeocare Laboratories COPPER; CUPRIC ARSENITE; LACTIC ACID, L-; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC 10; 10; 10; 10; 10 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 61727-335_669544d9-0335-4bae-bd29-4392567f3a10 61727-335 HUMAN OTC DRUG Sinus Relief ASAFETIDA,ECHINACEA ANGUSTIFOLIA,CALCIUM SULFIDE,POTASSIUM DICHROMATE,LUFFA OPERCULATA WHOLE,SILICON DIOXIDE,SINUSITISINUM. PELLET SUBLINGUAL 20120724 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ASAFETIDA; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA; LUFFA OPERCULATA WHOLE; POTASSIUM DICHROMATE; SILICON DIOXIDE; SINUSITISINUM 8; 8; 12; 9; 18; 10; 18 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 61727-336_ed197049-a510-4a1b-b3b7-6e91cbb7644a 61727-336 HUMAN OTC DRUG Skin Klear Acne Relief TRIBASIC CALCIUM PHOSPHATE,FUMARIA OFFICINALIS FLOWERING TOP,ARCTIUM LAPPA ROOT,SODIUM CHLORIDE,SAPONARIA OFFICINALIS ROOT,SILICON DIOXIDE,SOLIDAGO VIRGAUREA FLOWERING TOP,SULFUR,VIOLA TRICOLOR. PELLET SUBLINGUAL 20120724 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARCTIUM LAPPA ROOT; FUMARIA OFFICINALIS FLOWERING TOP; SAPONARIA OFFICINALIS ROOT; SILICON DIOXIDE; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; TRIBASIC CALCIUM PHOSPHATE; VIOLA TRICOLOR 4; 4; 4; 5; 12; 3; 5; 10; 4 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g 61727-337_860b9ffd-ef48-4a94-999e-086c231c086d 61727-337 HUMAN OTC DRUG EZ-Quit Control ANTIMONY TRISULFIDE, DIEFFENBACHIA SEGUINE,CADMIUM SULFATE,STRYCHNOS IGNATII SEED,LOBELIA INFLATA,STRYCHNOS NUX-VOMICA SEED, TOBACCO LEAF. SPRAY SUBLINGUAL 20120709 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ANTIMONY TRISULFIDE; CADMIUM SULFATE; DIEFFENBACHIA SEGUINE; LOBELIA INFLATA; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 5; 5; 5; 5; 5; 5; 8 [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL 61727-338_4c7af6f2-d53c-4d20-a5b2-818331e2b442 61727-338 HUMAN OTC DRUG EZ-Detox Super Drainage Formula AESCULUS HIPPOCASTANUM BARK,ANTIMONY TRISULFIDE,SILVER NITRATE,ARNICA MONTANA,BERBERIS VULGARIS WHOLE,ACTIVATED CHARCOAL,CEANOTHUS AMERICANUS WHOLE,CHOLESTEROL,CINCHONA BARK,CYNARA SCOLYMUS LEAF,EQUISETUM ARVENSE TOP,CONYZA CANADENSIS,FUCUS VESICULOSUS,GINKGO,HAMAMELIS VIRGINIANA LEAF,CHAMAELIRIUM LUTEUM ROOT,GOLDENSEAL,ARCTIUM LAPPA ROOT,LESPEDEZA CAPITATA FLOWERING TOP,RANUNCULUS BULBOSUS,DAIKON,ROBINIA PSEUDOACACIA BARK,TARAXACUM PALUSTRE ROOT,VIBURNUM PRUNIFOLIUM BARK,VITIS VINIFERA WHOLE. LIQUID ORAL 20120709 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ACTIVATED CHARCOAL; AESCULUS HIPPOCASTANUM BARK; ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARNICA MONTANA; BERBERIS VULGARIS WHOLE; CEANOTHUS AMERICANUS WHOLE; CHAMAELIRIUM LUTEUM ROOT; CHOLESTEROL; CINCHONA BARK; CONYZA CANADENSIS; CYNARA SCOLYMUS LEAF; DAIKON; EQUISETUM ARVENSE TOP; FUCUS VESICULOSUS; GINKGO; GOLDENSEAL; HAMAMELIS VIRGINIANA LEAF; LESPEDEZA CAPITATA FLOWERING TOP; RANUNCULUS BULBOSUS; ROBINIA PSEUDOACACIA BARK; SILVER NITRATE; TARAXACUM PALUSTRE ROOT; VIBURNUM PRUNIFOLIUM BARK; VITIS VINIFERA WHOLE 9; 6; 10; 6; 6; 6; 6; 6; 10; 8; 6; 6; 6; 6; 6; 10; 6; 6; 6; 4; 10; 10; 6; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 61727-339_8d8c4f3c-405b-425d-ae95-55988b172b6f 61727-339 HUMAN OTC DRUG Acute Asthma Relief ACONITUM NAPELLUS,ARSENIC TRIOXIDE,BLATTA ORIENTALIS,SOLANUM DULCAMARA TOP,IPECAC,NAPHTHALENE,QUEBRACHO BARK, PHOSPHORUS,HISTAMINE DIHYDROCHLORIDE PELLET SUBLINGUAL 20120516 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BLATTA ORIENTALIS; HISTAMINE DIHYDROCHLORIDE; IPECAC; NAPHTHALENE; PHOSPHORUS; QUEBRACHO BARK; SOLANUM DULCAMARA TOP 10; 10; 7; 7; 6; 10; 8; 3; 10 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g 61727-340_4083ce3d-9d29-4df8-aae0-3a164cd60f6c 61727-340 HUMAN OTC DRUG Memo-Rx HORSE CHESTNUT,ALUMINUM OXIDE,SEMECARPUS ANACARDIUM JUICE,BARIUM CARBONATE,BOS TAURUS CEREBELLUM,GINKGO,POTASSIUM PHOSPHATE, DIBASIC. PELLET SUBLINGUAL 20120720 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ALUMINUM OXIDE; BARIUM CARBONATE; BOS TAURUS CEREBELLUM; GINKGO; HORSE CHESTNUT; POTASSIUM PHOSPHATE, DIBASIC; SEMECARPUS ANACARDIUM JUICE 5; 5; 5; 5; 5; 5; 5 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g 61727-341_f8e4f799-6574-40fc-b496-d4b08b792410 61727-341 HUMAN OTC DRUG Influenzinum Influenzinum 9C PELLET SUBLINGUAL 20121031 UNAPPROVED HOMEOPATHIC Homeocare Laboratories INFLUENZA A VIRUS; INFLUENZA B VIRUS 9; 9 [hp_C]/4g; [hp_C]/4g 61727-342_e2e36af1-4d99-45ee-84a1-546346b34b19 61727-342 HUMAN OTC DRUG Relaxagen SILVER NITRATE,ACONITUM NAPELLUS,GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS IGNATII SEED,POTASSIUM PHOSPHATE, DIBASIC,SILICON DIOXIDE LIQUID ORAL 20120914 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ACONITUM NAPELLUS; ACONITUM NAPELLUS; ACONITUM NAPELLUS; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM PHOSPHATE, DIBASIC; SILICON DIOXIDE; SILVER NITRATE; SILVER NITRATE; SILVER NITRATE; SILVER NITRATE; STRYCHNOS IGNATII SEED 15; 30; 9; 9; 8; 8; 10; 15; 30; 9; 9 [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL; [hp_X]/50mL; [hp_C]/50mL 61727-400_508572b9-041b-4cfa-9c6d-8ae3b973a6e4 61727-400 HUMAN OTC DRUG Neti Mist Sinus Spray POTASSIUM CHLORIDE LIQUID NASAL 20111114 UNAPPROVED HOMEOPATHIC Homeocare Laboratories POTASSIUM CHLORIDE 6 [hp_X]/29.5mL 61727-401_d2fd40e2-492a-40d4-a464-2f530fa6a14a 61727-401 HUMAN OTC DRUG Neti Wash Flu HAEMOPHILUS INFLUENZAE TYPE B LIQUID ORAL 20120105 UNAPPROVED HOMEOPATHIC Homeocare Laboratories HAEMOPHILUS INFLUENZAE TYPE B 9 [hp_C]/29.5mL 61734-000_bd6410e2-f3be-498b-b5f0-06e51017180a 61734-000 HUMAN OTC DRUG Hand Sanitizer Moisturizing with Vitamin E and Glycerin Ethyl Alcohol GEL TOPICAL 20100507 OTC MONOGRAPH NOT FINAL part333 Delon Laboratories (1990) Ltd ALCOHOL 62 mg/117.6mL 61734-010_ff22ae55-2ec9-41c8-abf3-5f11ec985580 61734-010 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part356 Delon Laboratories (1990) Ltd HYDROGEN PEROXIDE 3 mL/100mL 61734-012_90b1b98e-3849-40ce-89f8-2ed33d0a63e2 61734-012 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70 Isopropyl Alcohol SOLUTION TOPICAL 20100507 OTC MONOGRAPH NOT FINAL part333A Delon Laboratories (1990) Ltd. ISOPROPYL ALCOHOL 70 mL/100mL 61734-021_6f443551-7b82-4d0d-ac6f-47931a2be089 61734-021 HUMAN OTC DRUG Blue Ice Analgesic Menthol GEL TOPICAL 20100507 OTC MONOGRAPH FINAL part348 Delon Laboratories (1990) Ltd MENTHOL 2 g/100g 61734-030_f6c554a5-525f-4d29-b306-98dff7eb9dfd 61734-030 HUMAN OTC DRUG Vaporizing Colds Rub Menthol OINTMENT TOPICAL 20110524 OTC MONOGRAPH FINAL part341 Delon Laboratories (1990) Ltd CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.73; 1.2; 2.6 g/100g; g/100g; g/100g 61734-040_8339c3ff-27df-47b9-b6da-7df647312744 61734-040 HUMAN OTC DRUG Petroleum Petrolatum JELLY TOPICAL 20100507 OTC MONOGRAPH FINAL part347 Delon Laboratories (1990) Ltd PETROLATUM 100 g/100g 61734-050_e21ee818-b1d9-44a0-89ef-79aaf6e2a7b0 61734-050 HUMAN OTC DRUG Babyfresh Petroleum Jelly Petrolatum JELLY TOPICAL 20100507 OTC MONOGRAPH FINAL part347 Delon Laboratories (1990) Ltd PETROLATUM 99.7 g/100g 61734-070_f65d87dd-2328-4f26-9614-b857d551934b 61734-070 HUMAN OTC DRUG Zincoxide Zinc Oxide CREAM TOPICAL 20141007 OTC MONOGRAPH FINAL part347 Delon Laboratories (1990) Ltd ZINC OXIDE 15 g/100g 61734-085_7ab96845-be40-4280-90ef-01e07a46155a 61734-085 HUMAN OTC DRUG Hand Sanitizer with Moisturizers Vitamin E and Aloe Ethyl Alcohol GEL TOPICAL 20101001 OTC MONOGRAPH FINAL part333 Delon Laboratories (1990) Ltd ALCOHOL 62 mg/117.6mL 61734-090_f5281fc3-5bee-499f-b9df-c89b3386fc5a 61734-090 HUMAN OTC DRUG La Vaquita Extra Strength Methyl Salicylate OINTMENT TOPICAL 20101107 OTC MONOGRAPH FINAL part348 Delon Laboratories (1990) Ltd CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL; METHYL SALICYLATE 2; 1; 3; 12 g/100g; g/100g; g/100g; g/100g 61734-091_61ba670d-b5bb-44d7-9864-cf520bed36b6 61734-091 HUMAN OTC DRUG La Vaquita Methyl Salicylate OINTMENT TOPICAL 20101107 OTC MONOGRAPH FINAL part348 Delon Laboratories (1990) Ltd CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL; METHYL SALICYLATE 1; 1; 2; 10 g/100g; g/100g; g/100g; g/100g 61734-102_e562a3f4-0ab8-49a9-a3fd-32a404a6ea26 61734-102 HUMAN OTC DRUG Hand Sanitizer Non-Alcohol Benzethonium LIQUID TOPICAL 20100520 OTC MONOGRAPH FINAL part333 Delon Laboratories (1990) Ltd BENZETHONIUM CHLORIDE .2 mg/100mL 61734-105_a6431d68-b303-410f-9051-3a86a77fb85c 61734-105 HUMAN OTC DRUG Hand Sanitizer Moisturizing with Vitamin E and Glycerin Ethyl Alcohol GEL TOPICAL 20100507 OTC MONOGRAPH NOT FINAL part333E Delon Laboratories (1990) Ltd ALCOHOL 62 mg/117.6mL 61734-106_614d3761-1db2-48dd-882b-d4c60e87bbbf 61734-106 HUMAN OTC DRUG Hand Sanitizer Moisturizing with Vitamin E and Glycerin Ethyl Alcohol GEL TOPICAL 20100507 OTC MONOGRAPH NOT FINAL part333E Delon Laboratories (1990) Ltd ALCOHOL 62 mg/117.6mL 61734-107_13b8ed5e-3762-4b8a-b37d-909099ffda3e 61734-107 HUMAN OTC DRUG Hand Sanitizer Moisturizing with Vitamin E and Glycerin Ethyl Alcohol GEL TOPICAL 20100507 OTC MONOGRAPH FINAL part333 Delon Laboratories (1990) Ltd ALCOHOL 62 mg/117.6mL 61734-200_32b4387e-31cc-4a64-b701-26506b3504a0 61734-200 HUMAN OTC DRUG Apanol Alcanfor Camphor OINTMENT TOPICAL 20101119 OTC MONOGRAPH FINAL part348 Delon Laboratories (1990) Ltd CAMPHOR (SYNTHETIC) 10 g/100g 61734-201_b7ac3ac1-04d9-49c0-899b-98180d988a8b 61734-201 HUMAN OTC DRUG Apanol Arthritis Extra Strength Menthol, Methyl Salicylate OINTMENT TOPICAL 20101119 OTC MONOGRAPH FINAL part348 Delon Laboratories (1990) Ltd MENTHOL; METHYL SALICYLATE 10; 27 g/100g; g/100g 61734-202_9b731afa-3e6d-4a24-8cd8-9cc678c7cf57 61734-202 HUMAN OTC DRUG Apanol Athletics Camphor, Menthol OINTMENT TOPICAL 20100615 OTC MONOGRAPH FINAL part348 Delon Laboratories (1990) Ltd CAMPHOR (SYNTHETIC); MENTHOL 11; 10 g/100g; g/100g 61734-203_44912d52-7216-406f-8aa3-2c494012bd24 61734-203 HUMAN OTC DRUG Apanol Linimento Obrero Methyl Salicylate, Capsaicin OINTMENT TOPICAL 20101107 OTC MONOGRAPH FINAL part348 Delon Laboratories (1990) Ltd CAPSAICIN; METHYL SALICYLATE 10; 27 g/100g; g/100g 61734-204_bc4904f0-50ec-476b-a197-41cda9dd552e 61734-204 HUMAN OTC DRUG Apanol Muscle Rub Camphor, Menthol, Methyl Salicylate OINTMENT TOPICAL 20101107 OTC MONOGRAPH FINAL part348 Delon Laboratories (1990) Ltd CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 6; 18 g/100g; g/100g; g/100g 61734-300_c0634432-fdd0-4e71-9188-f8f02465e10c 61734-300 HUMAN OTC DRUG La Vaquita New Regular Methyl Salicylate OINTMENT TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part348 Delon Laboratories (1990) Ltd MENTHOL; METHYL SALICYLATE 2; 10 g/100g; g/100g 61734-301_bcac8bf0-88e8-4cf2-9932-6416131c33f5 61734-301 HUMAN OTC DRUG La Vaquita New Extra Methyl Salicylate, Menthol OINTMENT TOPICAL 20110426 OTC MONOGRAPH NOT FINAL part348 Delon Laboratories (1990) Ltd MENTHOL; METHYL SALICYLATE 3; 12 g/100g; g/100g 61734-400_edbde556-5a45-4c3d-99b9-7b654f857d80 61734-400 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 90 Isopropyl Alcohol SOLUTION TOPICAL 20100507 OTC MONOGRAPH NOT FINAL part333A Delon Laboratories (1990) Ltd ISOPROPYL ALCOHOL 90 mL/100mL 61734-410_8db10670-21ce-4300-84c4-809b9dd7c6b5 61734-410 HUMAN OTC DRUG Petroleum Jelly with Coconut and Aloe Petrolatum JELLY TOPICAL 20140829 OTC MONOGRAPH FINAL part347 Delon Laboratories (1990) Ltd PETROLATUM 99.8 g/100g 61734-411_f587b069-21c0-4e88-b362-cb60d322929e 61734-411 HUMAN OTC DRUG Petroleum Jelly with Shea Butter and Argan Oil Petrolatum JELLY TOPICAL 20140902 OTC MONOGRAPH FINAL part347 Delon Laboratories (1990) Ltd PETROLATUM 99.8 g/100g 61734-412_312ea8e1-fa0e-4a44-94cf-3a80dec0ce0b 61734-412 HUMAN OTC DRUG Petroleum Jelly with Lavender and Vanilla Petrolatum JELLY TOPICAL 20140902 OTC MONOGRAPH FINAL part347 Delon Laboratories (1990) Ltd PETROLATUM 99.8 g/100g 61734-415_f8257a2d-113d-4c02-936c-e5d0abef274d 61734-415 HUMAN OTC DRUG Anti-Itch Scalp Relief Maximum Strength Hydrocortisone SOLUTION TOPICAL 20140908 OTC MONOGRAPH NOT FINAL part348 Delon Laboratories (1990) Ltd HYDROCORTISONE 1 g/100g 61744-050_d6658aeb-7bc1-4eef-ad0d-0a873ddbecf5 61744-050 HUMAN PRESCRIPTION DRUG IMPAVIDO miltefosine CAPSULE ORAL 20140919 NDA NDA204684 Paladin Therapeutics Inc. MILTEFOSINE 50 mg/1 Antileishmanial [EPC] 61748-012_ecee3128-a47f-4ced-a1db-4f58c5f3e9c6 61748-012 HUMAN PRESCRIPTION DRUG Pyrazinamide Pyrazinamide TABLET ORAL 19950401 ANDA ANDA081319 VersaPharm Incorporated PYRAZINAMIDE 500 mg/1 Antimycobacterial [EPC] 61748-013_1247f0c8-25be-49b0-96e1-22b1cf50dc00 61748-013 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19970901 ANDA ANDA087425 VersaPharm Incorporated ISONIAZID 300 mg/1 Antimycobacterial [EPC] 61748-015_9dbaffcd-4e71-4ea0-9adb-634a2af7b857 61748-015 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20010701 ANDA ANDA065028 VersaPharm Incorporated RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 61748-016_1247f0c8-25be-49b0-96e1-22b1cf50dc00 61748-016 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19970901 ANDA ANDA080212 VersaPharm Incorporated ISONIAZID 100 mg/1 Antimycobacterial [EPC] 61748-017_1d3f27ec-1616-40fd-bc4f-91bb1744ceb0 61748-017 HUMAN PRESCRIPTION DRUG IsonaRif Rifampin and Isoniazid CAPSULE ORAL 20050901 ANDA ANDA065221 VersaPharm Incorporated ISONIAZID; RIFAMPIN 150; 300 mg/1; mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient],Antimycobacterial [EPC] 61748-018_9dbaffcd-4e71-4ea0-9adb-634a2af7b857 61748-018 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20010701 ANDA ANDA065028 VersaPharm Incorporated RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 61748-024_aa34937d-3a90-4659-b6b4-dd1412db2225 61748-024 HUMAN PRESCRIPTION DRUG Ethosuximide Ethosuximide SOLUTION ORAL 20040101 ANDA ANDA040506 VersaPharm Incorporated ETHOSUXIMIDE 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 61748-025_ea863fbc-c47d-4130-a9b7-10b53f1db0e5 61748-025 HUMAN PRESCRIPTION DRUG Ethosuximide Ethosuximide CAPSULE ORAL 20080901 ANDA ANDA040686 VersaPharm Incorporated ETHOSUXIMIDE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 61748-044_49a23821-76f9-45a4-a79b-aff14769bad1 61748-044 HUMAN PRESCRIPTION DRUG Aminocaproic Acid Aminocaproic Acid SYRUP ORAL 20000301 ANDA ANDA074759 VersaPharm Incorporated AMINOCAPROIC ACID .25 g/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 61748-045_49a23821-76f9-45a4-a79b-aff14769bad1 61748-045 HUMAN PRESCRIPTION DRUG Aminocaproic Acid Aminocaproic Acid TABLET ORAL 20010801 ANDA ANDA075602 VersaPharm Incorporated AMINOCAPROIC ACID 500 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 61748-046_49a23821-76f9-45a4-a79b-aff14769bad1 61748-046 HUMAN PRESCRIPTION DRUG Aminocaproic Acid Aminocaproic Acid TABLET ORAL 20120601 NDA AUTHORIZED GENERIC NDA015197 VersaPharm Incorporated AMINOCAPROIC ACID 1000 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 61748-054_17402030-cc8f-40ba-ac8a-865fce102c03 61748-054 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride SYRUP ORAL 20010301 ANDA ANDA040251 VersaPharm Incorporated TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/5mL 61748-111_41fd9969-059c-47a6-a424-4382804407c0 61748-111 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19980401 ANDA ANDA062396 VersaPharm Incorporated DOXYCYCLINE HYCLATE 100 mg/1 61748-113_95e1d2b0-56ab-4628-a762-d086f52fd127 61748-113 HUMAN PRESCRIPTION DRUG demeclocycline hydrochloride demeclocycline hydrochloride TABLET, FILM COATED ORAL 20081215 ANDA ANDA065389 VersaPharm Incorporated DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 61748-115_95e1d2b0-56ab-4628-a762-d086f52fd127 61748-115 HUMAN PRESCRIPTION DRUG demeclocycline hydrochloride demeclocycline hydrochloride TABLET, FILM COATED ORAL 20081215 ANDA ANDA065389 VersaPharm Incorporated DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 61748-200_2bc21396-13d3-4e4a-8260-153f4e2c15f2 61748-200 HUMAN PRESCRIPTION DRUG CICLOPIROX CICLOPIROX SOLUTION TOPICAL 20100320 ANDA ANDA078975 VersaPharm Incorporated CICLOPIROX 80 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 61748-201_46b9e41c-7dd9-46bf-9e1e-4a34e55b4ae9 61748-201 HUMAN PRESCRIPTION DRUG Clindamycin phosphate Clindamycin phosphate SOLUTION TOPICAL 20100710 ANDA ANDA065513 VersaPharm Incorporated CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 61748-202_f01651d8-68ae-4513-8df8-0cb77475aa9b 61748-202 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin SOLUTION TOPICAL 20100801 ANDA ANDA090215 VersaPharm Incorporated ERYTHROMYCIN 20 mg/mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 61748-205_c501cef7-dcfe-43b3-82d5-c15c94562fab 61748-205 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone GEL TOPICAL 20110411 ANDA ANDA090727 VersaPharm Incorporated DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61748-206_24156d16-17ab-4fa7-805f-f759914090b2 61748-206 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 20140912 ANDA ANDA201005 VersaPharm Incorporated DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61748-219_7d397347-421d-45cd-bdf3-26bfad2597b3 61748-219 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide LOTION TOPICAL 20130521 ANDA ANDA202374 VersaPharm Incorporated TRIAMCINOLONE ACETONIDE .25 mg/mL 61748-220_7d397347-421d-45cd-bdf3-26bfad2597b3 61748-220 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide LOTION TOPICAL 20130521 ANDA ANDA202374 VersaPharm Incorporated TRIAMCINOLONE ACETONIDE 1 mg/mL 61748-301_d488508a-1145-4c0d-b552-e505e49d9910 61748-301 HUMAN PRESCRIPTION DRUG Myorisan isotretinoin CAPSULE, LIQUID FILLED ORAL 20120501 ANDA ANDA076485 VersaPharm Incorporated ISOTRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 61748-302_d488508a-1145-4c0d-b552-e505e49d9910 61748-302 HUMAN PRESCRIPTION DRUG Myorisan isotretinoin CAPSULE, LIQUID FILLED ORAL 20120501 ANDA ANDA076485 VersaPharm Incorporated ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 61748-304_d488508a-1145-4c0d-b552-e505e49d9910 61748-304 HUMAN PRESCRIPTION DRUG Myorisan isotretinoin CAPSULE, LIQUID FILLED ORAL 20120501 ANDA ANDA076485 VersaPharm Incorporated ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 61748-400_ece04acb-bc22-46e4-8a97-e098bccca8e6 61748-400 HUMAN PRESCRIPTION DRUG Lindane Lindane SHAMPOO TOPICAL 20111121 ANDA ANDA087266 VersaPharm Incorporated LINDANE 10 mg/mL 61748-401_ae63df5b-5334-4e9a-a255-d9ea1144b0ce 61748-401 HUMAN PRESCRIPTION DRUG Lindane Lindane LOTION TOPICAL 20111205 ANDA ANDA087313 VersaPharm Incorporated LINDANE 10 mg/mL 61750-0022_a68ae80c-309d-47c0-bcde-09bfbaa9c492 61750-0022 HUMAN OTC DRUG Immuno Compound Homeopathic Tonic ALFALFA, AVENA SATIVA FLOWERING TOP, OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, SALIX NIGRA BARK LIQUID ORAL 20110214 UNAPPROVED HOMEOPATHIC HRC Laboratories, Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; GOLDENSEAL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SALIX NIGRA BARK 1; 1; 1; 1; 1 [hp_X]/236.6mL; [hp_X]/236.6mL; [hp_X]/236.6mL; [hp_X]/236.6mL; [hp_X]/236.6mL 61755-001_4c1233cf-261a-482e-9696-88981a4dd2b2 61755-001 HUMAN PRESCRIPTION DRUG Arcalyst rilonacept INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20080227 BLA BLA125249 Regeneron Pharmaceuticals, Inc. RILONACEPT 160 mg/2mL 61755-005_220f1049-67db-48a0-b8d3-63080f7cee37 61755-005 HUMAN PRESCRIPTION DRUG EYLEA aflibercept INJECTION, SOLUTION INTRAVITREAL 20111121 BLA BLA125387 Regeneron Pharmaceuticals, Inc. AFLIBERCEPT 40 mg/mL 61767-001_8f1f9218-cdf8-4217-af36-2269f532b7fe 61767-001 HUMAN OTC DRUG Mineral Oil MINERAL OIL ENEMA RECTAL 20140201 OTC MONOGRAPH NOT FINAL part334 Blossom Pharmaceuticals MINERAL OIL 118 mL/118mL 61767-002_4e78a959-948f-4b34-bd90-21ced9cb128a 61767-002 HUMAN OTC DRUG Saline enema SALINE ENEMA ENEMA RECTAL 20140201 OTC MONOGRAPH NOT FINAL part334 Blossom Pharmaceuticals SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 61767-219_e231c3af-75a8-42db-8a8c-743d92ec25d5 61767-219 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20140306 OTC MONOGRAPH FINAL part333B Blossom Pharmaceuticals BACITRACIN 500 [iU]/g 61767-220_0b739768-64f5-4905-89aa-bb043169d94b 61767-220 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20140514 OTC MONOGRAPH FINAL part333B Blossom Pharmaceuticals BACITRACIN ZINC 500 [USP'U]/g 61767-222_0aeacffd-4c75-4018-bbd6-f734980cb2b5 61767-222 HUMAN OTC DRUG Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20140514 OTC MONOGRAPH FINAL part347 Blossom Pharmaceuticals ZINC OXIDE 200 mg/g 61767-224_49f52e32-fdeb-43c5-a341-008d64a43514 61767-224 HUMAN OTC DRUG Hydrocortisone Hydrocortisone Acetate CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part348 Blossom Pharmaceuticals HYDROCORTISONE ACETATE 1 g/100g 61767-226_72edacb1-503c-4254-8b5b-e477ea55c617 61767-226 HUMAN OTC DRUG Dyna1195 zinc oxide OINTMENT TOPICAL 20141023 OTC MONOGRAPH FINAL part347 Blossom Pharmaceuticals ZINC OXIDE 1.8 g/100g 61767-228_3cfaedb1-70c1-43ee-baf5-5ff1b3454443 61767-228 HUMAN OTC DRUG Dyna1199 with Dimethicone zinc oxide OINTMENT TOPICAL 20141023 OTC MONOGRAPH FINAL part347 Blossom Pharmaceuticals DIMETHICONE; ZINC OXIDE 1.8; 2 g/100g; g/100g 61767-231_0be9814f-595e-47da-ae39-4def3d8ab994 61767-231 HUMAN OTC DRUG Blossom Pharmaceuticals Antifungal antifungal CREAM TOPICAL 20140509 OTC MONOGRAPH FINAL part333C Blossom Pharmaceticals CLOTRIMAZOLE 1 g/100g 61767-232_06eade62-c684-485c-bedc-ca7eef96f73c 61767-232 HUMAN OTC DRUG Lana1263 Lanolin OINTMENT TOPICAL 20141023 OTC MONOGRAPH FINAL part347 Blossom Pharmaceuticals LANOLIN 50 g/100g 61767-234_c19d6a7b-7523-47e9-aa39-7ac9ea666e81 61767-234 HUMAN OTC DRUG Menthol and Zinc Oxide Menthol and Zinc Oxide OINTMENT TOPICAL 20141011 OTC MONOGRAPH FINAL part347 Blossom Pharmaceuticals MENTHOL; ZINC OXIDE .44; 21 g/100g; g/100g 61767-304_6d01ed55-94e7-4d5f-831d-ea330fce8199 61767-304 HUMAN OTC DRUG Alcohol Isopropyl Alcohol LIQUID TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A Blossom Pharmaceuticals ISOPROPYL ALCOHOL .7 mL/mL 61767-305_41fb98df-814c-4a1a-a83e-cfcfa0bfdf2f 61767-305 HUMAN OTC DRUG Alcohol Isopropyl Alcohol LIQUID TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A Blossom Pharmaceuticals ISOPROPYL ALCOHOL .99 mL/mL 61767-306_606ce526-8f1e-4534-8e98-6858b0bd552b 61767-306 HUMAN OTC DRUG Blossom HP 3 Hydrogen peroxide LIQUID TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part356 Blossom Pharmaceuticals HYDROGEN PEROXIDE 2.65 mL/100mL 61767-406_7e55067e-7226-4055-b7fd-0399ede09bda 61767-406 HUMAN OTC DRUG Muscle rub Menthol, Camphor, Methyl Salicylate CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part348 Blossom Pharmaceuticals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g 61776-0001_94c7ccb8-080d-4f18-a65f-3e14fa1e9f13 61776-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19870101 UNAPPROVED MEDICAL GAS CMS Imaging Inc dba Medco OXYGEN 99 L/100L 61786-000_2b8d16ad-9c57-4cb3-8dcb-86312938fd6b 61786-000 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20140210 ANDA ANDA077206 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61786-001_4e917110-db62-4ad8-bb2f-5f40ef1c5150 61786-001 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20141218 ANDA ANDA077893 REMEDYREPACK INC. POLYETHYLENE GLYCOL 3350 17 g/1 Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 61786-001_9a3ae131-88a9-41af-a681-d8ba04289f52 61786-001 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20140805 ANDA ANDA077893 REMEDYREPACK INC. POLYETHYLENE GLYCOL 3350 17 g/1 Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 61786-003_49aa1197-d0a1-4eab-a413-a55e7a7d0383 61786-003 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20140805 NDA AUTHORIZED GENERIC NDA018238 REMEDYREPACK INC. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 61786-004_7bc3521b-7467-44e8-82a0-ca099569cc62 61786-004 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140807 ANDA ANDA076133 REMEDYREPACK INC. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 61786-005_7b22f517-cce0-4982-be04-2ec2721129d4 61786-005 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140807 ANDA ANDA076133 REMEDYREPACK INC. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 61786-006_fe0b3169-ee48-44aa-8691-5b7592ddaf98 61786-006 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140807 ANDA ANDA077415 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 61786-007_a47d00b9-2060-4a86-b277-e5a268413d95 61786-007 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20140813 ANDA ANDA078955 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 61786-008_4cc2b459-bd9c-4b9b-8321-c7dc2a7a5b93 61786-008 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20140813 ANDA ANDA090168 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 61786-010_edffaa81-dae8-4bc6-8e80-415f2c64c532 61786-010 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20140825 ANDA ANDA090170 REMEDYREPACK INC. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 61786-012_27c80efe-aa4d-4dfb-a703-fd82c0b6186d 61786-012 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE ORAL 20140825 ANDA ANDA040765 REMEDYREPACK INC. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 61786-013_95e34cba-a9a6-4164-b2de-ad259bc0ce3e 61786-013 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20140825 ANDA ANDA090168 REMEDYREPACK INC. BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 61786-013_fbfd8657-60ff-4298-a015-3a6c2a65974b 61786-013 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20141210 ANDA ANDA090168 REMEDYREPACK INC. BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 61786-014_02664c54-ede8-469f-92d4-36fbdded5fd6 61786-014 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 20140826 ANDA ANDA040254 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 61786-015_69461c3e-95dd-4ff8-b4df-42f1f62a64c1 61786-015 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140826 ANDA ANDA077455 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 61786-016_30c3a88e-8ec3-4c31-b203-27e63e91190b 61786-016 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20140826 ANDA ANDA091240 REMEDYREPACK INC. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61786-018_d0b31fae-81f9-4789-bcfa-5b54139348b0 61786-018 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20140828 ANDA ANDA090168 REMEDYREPACK INC. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 61786-019_6eb51d56-0e35-4151-81a1-5a601a264a43 61786-019 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140828 ANDA ANDA202419 REMEDYREPACK INC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 61786-020_c9432c0a-d043-46a5-8ae9-cd586773978c 61786-020 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20140829 ANDA ANDA074132 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 61786-021_d282bb62-9cea-428a-b0bc-1d0838661620 61786-021 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140903 ANDA ANDA075932 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 61786-023_ae192d5c-afd1-4c3c-b694-406870b6066b 61786-023 HUMAN PRESCRIPTION DRUG glipizide glipizide TABLET ORAL 20140930 ANDA ANDA077820 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 61786-023_d7657d0d-41bf-4510-bd84-2c42d76a2f56 61786-023 HUMAN PRESCRIPTION DRUG glipizide glipizide TABLET ORAL 20140905 ANDA ANDA077820 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 61786-024_6398e94f-6c56-4ec0-9101-5051740657e9 61786-024 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20140909 ANDA ANDA202477 REMEDYREPACK INC. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 61786-025_0596241c-ec87-438d-a536-509f23b49465 61786-025 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 20140910 ANDA ANDA085692 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 1 mg/g 61786-026_03d23d27-c066-48d2-9a58-fb952c38bda1 61786-026 HUMAN PRESCRIPTION DRUG Flector Diclofenac Epolamine PATCH TOPICAL 20140911 NDA NDA021234 REMEDYREPACK INC. DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61786-027_d749343e-9e43-46b4-8469-dcf9ff7ba0c2 61786-027 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRAMUSCULAR 20140912 NDA NDA011757 REMEDYREPACK INC. METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61786-029_01f83fe6-6c8e-477a-b2ea-eed60b6d540b 61786-029 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20140915 ANDA ANDA065125 REMEDYREPACK INC. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 61786-030_89d5dc41-3875-4df8-92a2-1d1691e349de 61786-030 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20140915 ANDA ANDA070035 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 61786-031_07d4b125-b771-4c15-9734-fa5ff421732f 61786-031 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20140915 ANDA ANDA074505 REMEDYREPACK INC. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 61786-032_9fee0d1e-3390-4b05-ba86-614bed3504fa 61786-032 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20140912 ANDA ANDA040901 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 61786-036_36ff72a2-596a-490f-a3f7-b3999d96fcc1 61786-036 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20140930 ANDA ANDA075511 REMEDYREPACK INC. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 61786-037_b368daa7-92f8-470a-bd18-a434062cdf09 61786-037 HUMAN PRESCRIPTION DRUG Ofloxacin Otic Ofloxacin SOLUTION AURICULAR (OTIC) 20140930 ANDA ANDA076527 REMEDYREPACK INC. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 61786-038_99e9f870-4d8a-4eb3-ac9d-8f4768f30632 61786-038 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20140930 ANDA ANDA090168 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 61786-041_a55fbaa6-ee9f-4f08-b234-b9238af4a5aa 61786-041 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20141003 ANDA ANDA075356 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61786-042_17196f95-e999-42bf-aad5-fce84329f4b7 61786-042 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20141003 ANDA ANDA077751 REMEDYREPACK INC. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 61786-043_d63f05f9-3337-4b30-af9b-c01e5906c365 61786-043 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20141003 ANDA ANDA074550 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 61786-046_1d69e163-4a7f-4ca0-8824-b7aaa2dc2987 61786-046 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20141003 ANDA ANDA077751 REMEDYREPACK INC. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 61786-048_885c637b-1a68-4695-a5eb-93d9ef4f473f 61786-048 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20141002 ANDA ANDA040682 REMEDYREPACK INC. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 61786-048_f7a9b377-bc26-4b63-9d95-874d70f6a718 61786-048 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20141110 ANDA ANDA040682 REMEDYREPACK INC. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 61786-049_17f77c15-ee17-4ff1-ace0-58765ecab097 61786-049 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20141020 ANDA ANDA083677 REMEDYREPACK INC. PREDNISONE 20 mg/1 61786-049_724a9a67-8848-4cb5-b385-fec9fd1e6760 61786-049 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20141002 ANDA ANDA083677 REMEDYREPACK INC. PREDNISONE 20 mg/1 61786-049_c571591c-f94b-481f-8ab3-e97dd2a79b58 61786-049 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20141008 ANDA ANDA083677 REMEDYREPACK INC. PREDNISONE 20 mg/1 61786-049_f18ad925-7c7b-4994-ba87-e38b7d682ccf 61786-049 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20141028 ANDA ANDA083677 REMEDYREPACK INC. PREDNISONE 20 mg/1 61786-051_711b94cb-706f-4925-889e-c05c0c6d0667 61786-051 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20141008 ANDA ANDA201109 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 61786-052_44e61de9-8b8d-4d14-8b36-9d4418e2c69f 61786-052 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20141008 ANDA ANDA077380 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 61786-053_a2482e02-e7ce-4b7f-85e4-7c119459c7e6 61786-053 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20141008 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 61786-054_459eb394-30b6-46e2-899c-379a8ea79b0a 61786-054 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20141008 ANDA ANDA077002 REMEDYREPACK INC. DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 61786-058_ef311424-39d3-48fa-bc0f-d6fd413c7dc0 61786-058 HUMAN PRESCRIPTION DRUG VIGAMOX moxifloxacin hydrochloride SOLUTION OPHTHALMIC 20141020 NDA NDA021598 REMEDYREPACK INC. MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 61786-059_e680dea5-e4e0-4a5a-8f2a-a1ee9aba12b9 61786-059 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20141013 ANDA ANDA086989 REMEDYREPACK INC. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 61786-064_06de03af-4cab-4a21-930f-2dd2022add4e 61786-064 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20141013 ANDA ANDA201109 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 61786-067_676d8b8b-b2a7-44aa-b91b-b2b8b0bddf62 61786-067 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20141014 ANDA ANDA040712 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 61786-068_da75c015-15f9-45c6-a2af-2c43bb56be42 61786-068 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20141020 ANDA ANDA079067 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 61786-069_2cebd671-4e84-46fb-9b46-bdc4f03c4561 61786-069 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141020 ANDA ANDA202419 REMEDYREPACK INC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 61786-071_06992466-5a5b-4c61-9498-237bb883fd1c 61786-071 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20141020 ANDA ANDA077995 REMEDYREPACK INC. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 61786-072_abde25cb-f26e-4465-abf7-1f8924e750f3 61786-072 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20141021 ANDA ANDA077562 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 61786-073_db4a255d-4e1c-416f-948d-6377ac778359 61786-073 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141230 ANDA ANDA077285 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 61786-074_3c243c32-bd20-4557-8951-126e64df5c4e 61786-074 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20141024 ANDA ANDA088467 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 61786-075_1f96c40a-02c0-4061-aac2-efc43ca0ccdb 61786-075 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20141112 ANDA ANDA065243 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 61786-075_d7d66118-6867-4d47-be68-c8baed0960cc 61786-075 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20141024 ANDA ANDA065243 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 61786-076_7d2f094b-7967-4dec-a949-6f2da7376252 61786-076 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20141024 ANDA ANDA202556 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 61786-077_0aaee79a-f791-49ce-8e31-1c8e5824125e 61786-077 HUMAN PRESCRIPTION DRUG Vasotec Enalapril Maleate TABLET ORAL 20141024 NDA NDA018998 REMEDYREPACK INC. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 61786-079_6a5204b3-4c48-4a74-8864-1c013962b3ca 61786-079 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141030 ANDA ANDA079163 REMEDYREPACK INC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 61786-080_eb0c50d1-e6e0-4d46-884b-af06c00d2b8f 61786-080 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20141030 ANDA ANDA075805 REMEDYREPACK INC. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 61786-081_50ffd980-6c1c-4d6b-af9e-53acf29a18fc 61786-081 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20141029 ANDA ANDA090478 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 61786-081_8a88e62d-299f-4ec6-b712-671e69492cd1 61786-081 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20141112 ANDA ANDA090478 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 61786-082_1550aff5-b2d6-45b1-a986-9dd8f4372e1e 61786-082 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 20141029 ANDA ANDA074802 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 60 mg/2mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61786-083_735a6789-ce34-46d4-8e26-98452b6812b5 61786-083 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20141030 ANDA ANDA077562 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 61786-084_ab638b37-3d3f-4a9b-b57f-07a98e159407 61786-084 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20141103 ANDA ANDA077901 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 61786-086_4d57b40a-491d-455e-a708-3e70f01eae22 61786-086 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20141106 ANDA ANDA076143 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 61786-088_42818b46-a640-4865-9cc5-990c9f2779ce 61786-088 HUMAN PRESCRIPTION DRUG ZOVIRAX acyclovir CAPSULE ORAL 20141110 NDA NDA018828 REMEDYREPACK INC. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 61786-089_9e9d35bc-8797-406f-9fc0-a94947b73a6f 61786-089 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20141112 ANDA ANDA076143 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 61786-090_a4a54090-ee0b-4051-883a-8047eab8333b 61786-090 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20141112 ANDA ANDA077562 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 61786-092_10c59578-e255-42eb-8c45-53fe563259b9 61786-092 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride TABLET ORAL 20141112 ANDA ANDA040659 REMEDYREPACK INC. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 61786-095_a7e34e55-a796-4d2f-b6e7-854a9af0a8c9 61786-095 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20141113 ANDA ANDA090469 REMEDYREPACK INC. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 61786-096_38596daa-d499-47a6-a44d-3048520ea8fa 61786-096 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20141117 ANDA ANDA076194 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 61786-097_ca914e33-9d54-4d5f-b7a9-e92086b3fa00 61786-097 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20141211 ANDA ANDA076639 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 61786-097_d2b06d0f-0772-44dd-a247-2f418e3ed80f 61786-097 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20141118 ANDA ANDA076639 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 61786-100_72532362-8b65-4973-9105-b0bdc795b9a4 61786-100 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20141126 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61786-101_1e86a2b0-089f-4a20-a2a8-de582b54e65e 61786-101 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20141126 ANDA ANDA202389 REMEDYREPACK INC. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61786-104_da8b4670-07b5-4013-ac13-8fd7e234ccc6 61786-104 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141126 ANDA ANDA079163 REMEDYREPACK INC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 61786-105_0efe9174-eb54-4956-8433-3d93bf8c14fa 61786-105 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 20141126 ANDA ANDA074649 REMEDYREPACK INC. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 61786-106_31debfcd-79e0-4a1e-8c55-a641f2fb4907 61786-106 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20141128 ANDA ANDA202389 REMEDYREPACK INC. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61786-107_12d730d2-c25c-4cbd-a7c9-f71807182148 61786-107 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20141201 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61786-108_1e2f7e8d-50d1-43a2-9584-57a380a0edb6 61786-108 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20141201 ANDA ANDA075536 REMEDYREPACK INC. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 61786-109_a7cba8f2-e8a1-4e27-9659-37a11596e955 61786-109 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20141204 ANDA ANDA077241 REMEDYREPACK INC. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 61786-111_b973463f-23cc-4f69-bc16-c2d28f73d7a4 61786-111 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20141205 ANDA ANDA079067 REMEDYREPACK INC. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 61786-115_1aea9849-cf02-4d8f-a9da-d6a0b94db47a 61786-115 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20141209 ANDA ANDA071251 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 61786-116_3896a95a-6dec-4bab-a234-ecba13b28ee5 61786-116 HUMAN PRESCRIPTION DRUG WELLBUTRIN bupropion hydrochloride TABLET, FILM COATED ORAL 20141209 NDA NDA018644 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 61786-117_90ae8eab-83cd-461a-96b4-4aa5fc516c3d 61786-117 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20141210 ANDA ANDA078888 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 30 mg/1 61786-118_fa221d5b-dc7e-4992-bed3-f045ee3a425f 61786-118 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20141226 ANDA ANDA090901 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 61786-120_03956349-d1b0-4196-92ba-4764ef523636 61786-120 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20141216 ANDA ANDA078616 REMEDYREPACK INC. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] 61786-121_9109fba0-66bf-4ca9-97ac-1fe321665455 61786-121 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20141215 ANDA ANDA077534 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61786-122_05ff1989-bb39-466a-b39f-97970f5360cf 61786-122 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20141216 ANDA ANDA065215 REMEDYREPACK INC. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 61786-123_73fb28e7-1eb0-4c75-8846-47ffebdec86b 61786-123 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20141218 ANDA ANDA090540 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 61786-124_799aba0b-c054-429a-9cee-d1a4bca41509 61786-124 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20141218 ANDA ANDA090493 REMEDYREPACK INC. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 61786-125_28031c80-44fd-4665-9eee-e63801dedd13 61786-125 HUMAN PRESCRIPTION DRUG Depakote Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141218 NDA NDA018723 REMEDYREPACK INC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 61786-126_47c48e81-4403-487c-9dd8-b8d1834be40c 61786-126 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20141218 ANDA ANDA040901 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 61786-127_996304c8-b77b-4d3a-bb96-e65e3753ad23 61786-127 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20141223 ANDA ANDA079067 REMEDYREPACK INC. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 61786-128_53e7c53a-94f8-4367-a57a-2727d5b5de96 61786-128 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20141224 ANDA ANDA202389 REMEDYREPACK INC. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61787-062_e70bcb6c-6ffb-474f-b388-7a6c8cc8c146 61787-062 HUMAN OTC DRUG Diabetic Tussin DM Dextromethorphan hydrobromide and Guaifenesin LIQUID ORAL 19970501 OTC MONOGRAPH FINAL part341 Health Care Products DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 61787-063_4b727b03-cd92-49f7-b30c-38b2610ff059 61787-063 HUMAN OTC DRUG Diabetic Tussin Expectorant Guaifenesin LIQUID ORAL 19960101 OTC MONOGRAPH FINAL part341 Health Care Products GUAIFENESIN 100 mg/5mL 61787-064_fd69e58d-a0cd-447b-b20e-681b12839907 61787-064 HUMAN OTC DRUG Diabetic Tussin DM Maximum Strength Dextromethorphan Hydrobromide and Guaifenesin LIQUID ORAL 19950703 OTC MONOGRAPH FINAL part341 Health Care Products DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/5mL; mg/5mL 61787-188_ee8d2593-6711-4733-84da-3d6edda0fd48 61787-188 HUMAN OTC DRUG Zostrix Foot Pain Relief capsaicin CREAM TOPICAL 20091001 20160331 OTC MONOGRAPH NOT FINAL part348 Health Care Products CAPSAICIN .75 mg/g 61787-423_40e7a942-c9ae-487f-b805-37b26c1ec7f7 61787-423 HUMAN OTC DRUG Zostrix Foot Pain Relief Capsaicin CREAM TOPICAL 20120904 OTC MONOGRAPH NOT FINAL part348 Health Care Products CAPSAICIN .25 mg/g 61787-442_d88419df-456d-4f22-b86d-d8c6584422b1 61787-442 HUMAN OTC DRUG Zostrix Original Strength Capsaicin CREAM TOPICAL 20060109 OTC MONOGRAPH NOT FINAL part348 Health Care Products CAPSAICIN .25 mg/g 61787-443_cd238ca3-bb8e-4c67-905d-404a4a38b823 61787-443 HUMAN OTC DRUG ZOSTRIX HP Capsaicin CREAM TOPICAL 20060109 OTC MONOGRAPH NOT FINAL part348 Health Care Products CAPSAICIN .75 mg/g 61787-445_847e1e47-a2c8-42e5-926c-265eeb62b460 61787-445 HUMAN OTC DRUG Diabetic Tussin Mucus Relief Guaifenesin TABLET ORAL 20010801 20150228 OTC MONOGRAPH FINAL part341 Health Care Products GUAIFENESIN 400 mg/1 61787-452_dad732cb-4936-433c-9bb0-5a0267f8e46c 61787-452 HUMAN OTC DRUG Diabetic Tussin Nighttime Cold and Flu Acetaminophen, Dextromethorphan HBr, and Diphenhydramine HCl LIQUID ORAL 20100801 OTC MONOGRAPH FINAL part341 Health Care Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE 325; 10; 12.5 mg/5mL; mg/5mL; mg/5mL 61787-482_8e61d498-8697-44be-93b0-feedaead9ae3 61787-482 HUMAN OTC DRUG Nasal Ease Allergy Reliever Potassium Dichromate POWDER NASAL 20090803 UNAPPROVED HOMEOPATHIC Health Care Products POTASSIUM DICHROMATE 200 [AU]/5.1g 61787-499_cf1001ec-b069-4d51-82e7-646a9583a43a 61787-499 HUMAN OTC DRUG Zostrix Hot and Cold Therapy System capsaicin and menthol KIT 20120808 OTC MONOGRAPH NOT FINAL part348 Health Care Products 61787-556_b4b89923-ab66-41be-8e27-905573afa948 61787-556 HUMAN OTC DRUG Zostrix High Potency Foot Pain Relief capsaicin CREAM TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part348 Health Care Products CAPSAICIN .75 mg/g 61787-557_006d3c32-0a88-4454-aa0f-5dcc2ba9a222 61787-557 HUMAN OTC DRUG Zostrix Joint and Arthritis Pain Relief Capsaicin and Menthol CREAM TOPICAL 20131112 OTC MONOGRAPH NOT FINAL part348 Health Care Products CAPSAICIN; MENTHOL .25; 20 mg/g; mg/g 61787-558_1085c67c-ce32-4d7a-a295-7caf524a0cff 61787-558 HUMAN OTC DRUG Diaderm Antifungal undecylenic acid CREAM TOPICAL 20131112 OTC MONOGRAPH FINAL part333C Health Care Products UNDECYLENIC ACID .1 g/g 61811-0001_e22c1146-96eb-4f41-bbfc-6d66c180ff63 61811-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19950505 UNAPPROVED MEDICAL GAS Bennett Medical Services OXYGEN 99 L/100L 61821-051_a1352d12-4677-4d4e-a91c-bb902edf7dfa 61821-051 HUMAN OTC DRUG EXTRA STRENGTH HUA TUO MEDICATED PLASTER CAMPHOR, MENTHOL, METHYL SALICYLATE PLASTER TOPICAL; TRANSDERMAL 20130617 OTC MONOGRAPH NOT FINAL part348 GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY CAMPHOR (SYNTHETIC); MENTHOL; MENTHYL SALICYLATE, (+/-)- 8.3; 3.32; 13.84 g/1; g/1; g/1 61821-052_8d4d6a2d-a552-4ee4-874b-10e4f6d45ed5 61821-052 HUMAN OTC DRUG DIEDA FENGSHI GAO MEDICATED PLASTER CAMPHOR, MENTHOL, METHYL SALICYLATE PLASTER TOPICAL; TRANSDERMAL 20130617 OTC MONOGRAPH NOT FINAL part348 GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY CAMPHOR (SYNTHETIC); MENTHOL; MENTHYL SALICYLATE, (+/-)- 8.3; 3.32; 13.84 g/1; g/1; g/1 61821-100_244a3007-842e-45ec-8997-0652cacef416 61821-100 HUMAN OTC DRUG Hua Tuo Medicated Plaster Extra Strength Menthol Camphor PATCH TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part348 Guangzhou Jing Xiu Tang Pharmaceutical Company Limited CAMPHOR (SYNTHETIC); MENTHOL 10; 3 g/1; g/1 61822-0045_fae1a956-099f-49e9-8b05-5e3f5c6b095f 61822-0045 HUMAN OTC DRUG WU YANG BRAND MEDICATED PLASTER MENTHOL, METHYL SALICYLATE PLASTER TOPICAL; TRANSDERMAL 20011019 OTC MONOGRAPH NOT FINAL part348 GUANGZHOU BAIYUNSHAN PHARMACEUTICAL CO., LTD. BAIYUNSHAN HEJIGONG PHARMACEUTICAL FACTORY MENTHOL; METHYL SALICYLATE 6; 10 g/1; g/1 61822-0046_634c815d-4401-4194-81eb-4b6e350f6554 61822-0046 HUMAN OTC DRUG 701 DIEDA ZHENGTONG YAOGAO MEDICATED PLASTER CAMPHOR , MENTHOL , METHYL SALICYLATE PLASTER TOPICAL; TRANSDERMAL 20011015 OTC MONOGRAPH NOT FINAL part348 GUANGZHOU BAIYUNSHAN PHARMACEUTICAL CO., LTD. BAIYUNSHAN HEJIGONG PHARMACEUTICAL FACTORY CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3.1; 8; 10 g/1; g/1; g/1 61822-0047_45c54fea-0fa5-42c0-8400-b783e3f36f40 61822-0047 HUMAN OTC DRUG YAT TIP TOR SALICYLIC ACID PLASTER TOPICAL; TRANSDERMAL 20040426 OTC MONOGRAPH FINAL part358F GUANGZHOU BAIYUNSHAN PHARMACEUTICAL CO., LTD. BAIYUNSHAN HEJIGONG PHARMACEUTICAL FACTORY SALICYLIC ACID 40 g/1 61827-056_7e6e44d2-1a49-43a4-a037-9028d9399171 61827-056 HUMAN OTC DRUG Spring Grove Unscented Hand Sanitizer Spring Grove Unscented Hand Sanitizer SOLUTION TOPICAL 20131105 OTC MONOGRAPH NOT FINAL part333A Saalfeld Paper ALCOHOL 62.5 mL/100mL 61830-001_0009c00b-be68-4865-9b66-eae8cd6ee7a4 61830-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20140627 NDA NDA205840 Gemstone Gas LLC OXYGEN 99 L/100L 61834-0001_fe05f007-88e3-4501-92fe-13ff1060ec05 61834-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19370101 UNAPPROVED MEDICAL GAS J & A Medical Home Care Inc. OXYGEN 99 L/100L 61852-046_e154904f-045d-407e-a148-5b57049b209a 61852-046 HUMAN OTC DRUG swiss hand guard antiseptic handwash antibacterial Alcohol GEL TOPICAL 20120131 OTC MONOGRAPH FINAL part333A OPI Products In ALCOHOL 80.4 mL/120mL 61852-637_785c0b14-8935-4688-8df3-309543d8a7f8 61852-637 HUMAN OTC DRUG SEPHORA BY OPI MOISTURIZING HAND SANITIZER ALCOHOL SPRAY TOPICAL 20100722 OTC MONOGRAPH FINAL part333 OPI Products Inc. ALCOHOL 65 mL/100mL 61852-977_dfb73c06-c7e7-4e47-aff8-dd2a1993eb16 61852-977 HUMAN OTC DRUG MANICURE BY OPI - FINISHING BUTTER OCTINOXATE, OXYBENZONE CREAM TOPICAL 20100722 OTC MONOGRAPH FINAL part352 OPI Products, Inc OCTINOXATE; OXYBENZONE 7.5; 3.5 mL/100mL; mL/100mL 61852-978_8c96a39b-29c7-4d2d-ab52-546aa488c362 61852-978 HUMAN OTC DRUG MANICURE BY OPI - FINISHING BUTTER OCTINOXATE, OXYBENZONE CREAM TOPICAL 20100722 OTC MONOGRAPH FINAL part352 OPI Products, Inc OCTINOXATE; OXYBENZONE 7.5; 3.5 mL/100mL; mL/100mL 61856-101_b07db527-e777-41f7-b783-2fb77ec54433 61856-101 HUMAN OTC DRUG TOY CLEANER MIST ANTIBACTERIAL BENZALKONIUM CHLORIDE SPRAY TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A WESTRIDGE LABORATORIES INC BENZALKONIUM CHLORIDE .1 g/100mL 61867-101_de2ac42e-008e-4d9a-9fc7-e40f28ebd216 61867-101 HUMAN OTC DRUG SOLE SERUM LIDOCAINE SPRAY TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part348 THE COMFORT LAB LLC LIDOCAINE 4 g/100mL 61869-0001_4e8728f9-a77e-46b5-b183-9f9f08c0cf0c 61869-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040201 UNAPPROVED MEDICAL GAS Professional PRN LLC dba Northside Oxygen & Medical Equipment OXYGEN 99 L/100L 61871-001_092879ce-ee62-4d26-b4ef-b17465139a7b 61871-001 HUMAN OTC DRUG Novarnica camphor and menthol SPRAY TOPICAL 20140122 OTC MONOGRAPH NOT FINAL part348 Xcentrik Inc. CAMPHOR (NATURAL); MENTHOL 4; 8 g/100mL; g/100mL 61877-0001_ba0f3389-6b7e-4c14-a323-5975880d5084 61877-0001 HUMAN OTC DRUG TESTALL NOT APPLICABLE GEL TOPICAL 20141022 UNAPPROVED HOMEOPATHIC Strike First Nutrition SOMATROPIN; TESTOSTERONE 30; 6 [hp_X]/g; [hp_X]/g 61884-1001_77692e1d-b9af-4e80-ad1d-9f3db05df167 61884-1001 HUMAN OTC DRUG Sayak GLYCERIN CREAM TOPICAL 20140130 OTC MONOGRAPH FINAL part347 GMS GLYCERIN .02 g/g 61894-000_73b37cc8-ca99-4eec-bd89-dae86ce9407e 61894-000 HUMAN PRESCRIPTION DRUG Aceon perindopril erbumine TABLET ORAL 20141010 NDA NDA020184 Symplmed, LLC PERINDOPRIL ERBUMINE 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 61894-001_73b37cc8-ca99-4eec-bd89-dae86ce9407e 61894-001 HUMAN PRESCRIPTION DRUG Aceon perindopril erbumine TABLET ORAL 20141010 NDA NDA020184 Symplmed, LLC PERINDOPRIL ERBUMINE 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 61894-002_73b37cc8-ca99-4eec-bd89-dae86ce9407e 61894-002 HUMAN PRESCRIPTION DRUG Aceon perindopril erbumine TABLET ORAL 20141010 NDA NDA020184 Symplmed, LLC PERINDOPRIL ERBUMINE 8 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 61903-001_51b66034-b74e-4993-9cf0-4b8e8b5c3cf9 61903-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20131101 UNAPPROVED MEDICAL GAS Deaconess Home Services dba Deaconess Home Medical Equipment & Infusion OXYGEN 99 L/100L 61912-001_2131a1c6-ef0f-4c0d-9155-16846244c1ed 61912-001 HUMAN OTC DRUG PAIN-EASE CAMPHOR (NATURAL) MENTHOL METHYL SALICYLATE LOTION TOPICAL 20100924 OTC MONOGRAPH FINAL part348 VITALIFE INC DBA TABAK'S HEALTH PRODUCTS CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE .028; .088; .28 mg/mL; mg/mL; mg/mL 61912-003_3e79bfe3-c791-465c-b4b4-ebc5601b3dbf 61912-003 HUMAN OTC DRUG ARTHRITIS-EASE CAUSTICUM CHAMOMILE ARNICA CORDIFOLIA FLOWER LEDUM PALUSTRE TWIG KALMIA ANGUSTIFOLIA LEAF RHUS AROMATICA ROOT BARK BRYONIA ALBA ROOT RHODODENDRON AUREUM LEAF SOLANUM DULCAMARA FLOWER CAPSULE, GELATIN COATED ORAL 20110320 UNAPPROVED HOMEOPATHIC VITALIFE INC DBA TABAK'S HEALTH PRODUCTS ARNICA CORDIFOLIA FLOWER; BRYONIA ALBA ROOT; CAUSTICUM; CHAMOMILE; KALMIA ANGUSTIFOLIA LEAF; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; RHUS AROMATICA ROOT BARK; SOLANUM DULCAMARA FLOWER 30; 30; 30; 30; 30; 30; 30; 30; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 61912-103_be4fe6c7-6cc3-435d-98cb-cbef45435baa 61912-103 HUMAN OTC DRUG ArthriPure CAUSTICUM CHAMOMILE ARNICA CORDIFOLIA FLOWER LEDUM PALUSTRE TWIG KALMIA ANGUSTIFOLIA LEAF RHUS AROMATICA ROOT BARK BRYONIA ALBA ROOT RHODODENDRON AUREUM LEAF SOLANUM DULCAMARA FLOWER CAPSULE, GELATIN COATED ORAL 20110320 UNAPPROVED HOMEOPATHIC VITALIFE INC DBA TABAK'S HEALTH PRODUCTS ARNICA CORDIFOLIA FLOWER; BRYONIA ALBA ROOT; CAUSTICUM; CHAMOMILE; KALMIA ANGUSTIFOLIA LEAF; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; RHUS AROMATICA ROOT BARK; SOLANUM DULCAMARA FLOWER 30; 30; 30; 30; 30; 30; 30; 30; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 61919-001_58f10fc6-a26c-450a-a0eb-e7b5f740b223 61919-001 HUMAN PRESCRIPTION DRUG ANTIPYRINE AND BENZOCAINE ANTIPYRINE AND BENZOCAINE LIQUID TOPICAL 20140101 UNAPPROVED DRUG OTHER DIRECT RX ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 61919-002_5823cf02-5cb4-42c2-8caf-fb329932c5f6 61919-002 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE ORAL 20140101 NDA NDA022370 DIRECT RX TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 61919-003_5e6036d6-c2b7-495d-ada4-fec1d7a4a4c2 61919-003 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR TABLET ORAL 20140101 ANDA ANDA077309 DIRECT RX ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 61919-005_e7d9ae29-6119-4e56-973e-ed1fa6523205 61919-005 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ALPRAZOLAM TABLET ORAL 20140101 ANDA ANDA074112 Direct Rx ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 61919-006_4ba5098b-1948-4aa2-aee0-c4e23ec86744 61919-006 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ALPRAZOLAM TABLET ORAL 20140101 ANDA ANDA078491 DIRECT RX ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 61919-008_05fa0adb-c809-48da-b961-3909b965ec76 61919-008 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE tablet TABLET ORAL 20140101 ANDA ANDA091179 Direct Rx PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 61919-009_ca7cb4d1-cdb4-4b19-b2cb-8d3551248393 61919-009 HUMAN PRESCRIPTION DRUG MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET, FILM COATED ORAL 20140101 ANDA ANDA202717 DIRECT RX MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 61919-010_02263003-7437-45f5-a953-e31d5ddb7aef 61919-010 HUMAN PRESCRIPTION DRUG HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE CREAM TOPICAL 20140101 ANDA ANDA075666 DIRECT RX HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61919-011_9c4de565-c4bd-4a4f-9a59-928c65780fe4 61919-011 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20140101 ANDA ANDA040218 DIRECT RX AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 61919-012_cfe9ac1d-bd0d-4176-bb5a-3fb0d5de059f 61919-012 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA086009 Direct Rx AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 61919-013_7f300093-bd8c-4868-a581-ce4049c9de33 61919-013 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA086009 Direct Rx AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 61919-015_beecdb78-c9db-47ce-baba-7706bda4fe19 61919-015 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN POWDER, FOR SUSPENSION ORAL 20140101 ANDA ANDA065322 DIRECT RX AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 61919-017_13dc319c-e43b-4e7c-ac28-0d94cffd5a1e 61919-017 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN TABLET, FILM COATED ORAL 20140101 NDA NDA050754 Direct Rx AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 61919-022_d941014b-42af-43cb-88ab-1b48cf42cde5 61919-022 HUMAN PRESCRIPTION DRUG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET ORAL 20140101 ANDA ANDA089175 DIRECT RX ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 61919-023_3e561e3a-da4d-4acf-9ac4-ecd58e7b0fb7 61919-023 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE ACETAMINOPHEN AND CODEINE TABLET ORAL 20140101 ANDA ANDA040779 DIRECT RX ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 61919-026_0447851e-2bc0-4087-aa46-f4453d5737a8 61919-026 HUMAN PRESCRIPTION DRUG BACLOFEN BACLOFEN TABLET ORAL 20140101 ANDA ANDA072234 Direct Rx BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 61919-027_0447851e-2bc0-4087-aa46-f4453d5737a8 61919-027 HUMAN PRESCRIPTION DRUG BACLOFEN BACLOFEN TABLET ORAL 20140101 ANDA ANDA072235 Direct Rx BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 61919-029_83675fbc-f974-4ddd-9aff-a6b2d8c89fd5 61919-029 HUMAN PRESCRIPTION DRUG CEPHALEXIN CEPHALEXIN CAPSULE ORAL 20140101 ANDA ANDA062713 DIRECT RX CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 61919-031_8d8f53f8-06ef-40ad-b9fc-837ccc5f9d0d 61919-031 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE CAPSULE ORAL 20140101 ANDA ANDA040627 DIRECT RX BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 61919-038_590f5330-b4c4-4fd6-ad3b-270556ed8834 61919-038 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140101 ANDA ANDA078866 DIRECT RX BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 61919-039_3a9992e0-3fa7-42ad-b4a3-fb452b9eb647 61919-039 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20140101 ANDA ANDA040755 Direct Rx CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 61919-040_7ea80900-8c84-47cb-8bd9-668ab21d1664 61919-040 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET ORAL 20140101 ANDA ANDA090528 Direct Rx HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 61919-042_5125b289-e902-403d-9c39-73348043e569 61919-042 HUMAN PRESCRIPTION DRUG DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140101 ANDA ANDA203088 DIRECT RX DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61919-044_d8ab0daa-5507-4ac2-90a4-4e468f2f463e 61919-044 HUMAN PRESCRIPTION DRUG CEFUROXIME AXETIL CEFUROXIME AXETIL TABLET ORAL 20140101 ANDA ANDA065308 DIRECT RX CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 61919-046_f5bde2ec-dcf5-4ee4-b291-2c6825a2eb5e 61919-046 HUMAN PRESCRIPTION DRUG CELEBREX CELEBREX CAPSULE ORAL 20140101 NDA NDA020998 Direct Rx CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-047_fad07f9a-8e43-4512-a79c-acd66fa3c311 61919-047 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA091179 Direct Rx PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 61919-056_07f42faf-b0e3-4c2d-a214-cf47cd54d820 61919-056 HUMAN PRESCRIPTION DRUG CITALOPRAM CITALOPRAM TABLET ORAL 20140101 ANDA ANDA077032 DIRECT RX CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61919-058_d764b258-7109-4595-97b3-491117f05738 61919-058 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20140101 ANDA ANDA074869 DIRECT RX CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 61919-059_0af911cc-c691-4353-b314-837a075b8c18 61919-059 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20140101 ANDA ANDA074569 Direct Rx CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 61919-065_b90be9ce-7531-450b-b0be-5557ef590f6c 61919-065 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA090478 Direct Rx CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 61919-067_e8cbdc59-d552-4e25-a1e4-d70dbaef79a8 61919-067 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET ORAL 20140101 ANDA ANDA090485 Direct Rx ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 61919-070_1efb6f40-7e64-4914-84b4-a6677f026e7b 61919-070 HUMAN PRESCRIPTION DRUG DIAZEPAM DIAZEPAM TABLET ORAL 20140101 ANDA ANDA077749 DIRECT RX DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 61919-071_7339775a-0bb2-48aa-bbae-446fd4837806 61919-071 HUMAN PRESCRIPTION DRUG DIAZEPAM DIAZEPAM TABLET ORAL 20140101 ANDA ANDA077749 DIRECT RX DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 61919-072_5c7f5cf7-b1fe-4c8e-bdee-528328f9faba 61919-072 HUMAN PRESCRIPTION DRUG DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM TABLET, FILM COATED ORAL 20140101 ANDA ANDA075219 DIRECT RX DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-073_9c5f34a7-67bb-411b-beab-07bfeeabe2ab 61919-073 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, COATED ORAL 20140101 ANDA ANDA076003 DIRECT RX TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 61919-074_81fd52cf-b497-42d2-91df-7d4392f0b5f0 61919-074 HUMAN PRESCRIPTION DRUG Diclofenac Sodium D/R Diclofenac Sodium D/R TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA075185 Direct RX DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-075_81fd52cf-b497-42d2-91df-7d4392f0b5f0 61919-075 HUMAN PRESCRIPTION DRUG Diclofenac Sodium D/R Diclofenac Sodium D/R TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA075185 Direct RX DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-079_7957a6ca-7c37-49e6-96c7-ac6d8d1d0885 61919-079 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20140101 OTC MONOGRAPH FINAL part341 Direct Rx DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 61919-081_a3d1991b-6497-48c1-8088-3f3633913afd 61919-081 HUMAN PRESCRIPTION DRUG doxepin hydrochloride doxepin hydrochloride CAPSULE ORAL 20140101 ANDA ANDA070791 DIRECT RX DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 61919-083_d5dead26-8ba7-4d6b-9545-53431d94b991 61919-083 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20140101 ANDA ANDA075350 DIRECT RX GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 61919-084_bad07704-2eee-49b8-909d-1ed3e6ed0690 61919-084 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, FILM COATED ORAL 20140101 ANDA ANDA202152 DIRECT RX QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 61919-090_3e955b0d-d1e5-47b8-b11c-b99cec5f9df7 61919-090 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN ERYTHROMYCIN OINTMENT OPHTHALMIC 20140101 ANDA ANDA064067 Direct Rx ERYTHROMYCIN 5 g/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 61919-094_347e3c2d-b190-4566-bc5a-702e12441d85 61919-094 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED ORAL 20140101 ANDA ANDA020607 DIRECT RX DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 61919-099_d63a068b-094c-4181-9346-4d49b7d01179 61919-099 HUMAN PRESCRIPTION DRUG FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE ORAL 20140101 ANDA ANDA075049 DIRECT RX FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61919-100_2c61472d-0100-473d-bc10-d6fbc99639a4 61919-100 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20140101 ANDA ANDA076001 DIRECT RX FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61919-101_a2f34ad3-e6d8-4cc7-9ab0-7a7c19337f3f 61919-101 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20140101 ANDA ANDA077242 Direct Rx GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 61919-102_a2f34ad3-e6d8-4cc7-9ab0-7a7c19337f3f 61919-102 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20140101 ANDA ANDA077242 Direct Rx GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 61919-103_f99ef067-fb0f-4b74-86b8-7ff7f1564e0b 61919-103 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET ORAL 20140101 ANDA ANDA202764 DIRECT RX GABAPENTIN 600 1/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 61919-104_380b73dd-a3b4-4ca7-a385-37403278b983 61919-104 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET, FILM COATED ORAL 20140101 ANDA ANDA078926 DIRECT RX GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 61919-114_33b622ac-5b84-4e1f-8f97-3ef0fdf8c30f 61919-114 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20140101 ANDA ANDA040656 Direct Rx ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 61919-118_2688b220-9c7e-4e3f-ae36-ba41467face9 61919-118 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET ORAL 20140101 ANDA ANDA040746 DIRECT RX ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 61919-124_6a8ceffe-173a-40d1-9af1-3e197196f514 61919-124 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20140101 ANDA ANDA078558 Direct Rx IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-125_6a8ceffe-173a-40d1-9af1-3e197196f514 61919-125 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20140101 ANDA ANDA078558 Direct Rx IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-126_6a8ceffe-173a-40d1-9af1-3e197196f514 61919-126 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20140101 ANDA ANDA078558 Direct Rx IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-129_b4dd9b6e-886e-421a-80d2-6744ef8d22f2 61919-129 HUMAN PRESCRIPTION DRUG INDOMETHACIN INDOMETHACIN CAPSULE ORAL 20140101 ANDA ANDA091240 Direct Rx INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-139_34c61883-0c38-4c47-9de6-d426522d0897 61919-139 HUMAN PRESCRIPTION DRUG ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET ORAL 20140101 ANDA ANDA090939 Direct Rx ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61919-140_5fbec0e6-6c0c-4e5d-93aa-d1c5f1368fd1 61919-140 HUMAN PRESCRIPTION DRUG LIDOCAINE VISCOUS LIDOCAINE VISCOUS SOLUTION ORAL; TOPICAL 20140101 ANDA ANDA088802 Direct RX LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 61919-142_6ee697ed-2171-40ac-81cd-1e556dea2be6 61919-142 HUMAN OTC DRUG LORATADINE LORATADINE TABLET ORAL 20140101 ANDA ANDA076301 DIRECT RX LORATADINE 10 mg/1 61919-146_4c2ef586-e1e8-45df-9956-cfe0f52781a2 61919-146 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20140101 ANDA ANDA040659 DIRECT RX MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 61919-147_764f45b3-df3f-4f63-b038-0ec322f6ef4a 61919-147 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20140101 ANDA ANDA086988 Direct RX METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 61919-148_764f45b3-df3f-4f63-b038-0ec322f6ef4a 61919-148 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20140101 ANDA ANDA086988 Direct RX METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 61919-149_5a3d12b9-bd2b-4dad-93c3-7b9af98246f7 61919-149 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 20140101 ANDA ANDA040189 DIRECT RX METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61919-150_c6308ad1-9c5a-4c03-8556-24abd639ff60 61919-150 HUMAN PRESCRIPTION DRUG METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA072801 DIRECT RX METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 61919-152_29a9065b-19ed-48a6-bd62-1c62729c1c5c 61919-152 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE TABLET ORAL 20140101 ANDA ANDA070044 DIRECT RX METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 61919-155_2a624cd2-17e4-47e9-8f26-21c338a439f6 61919-155 HUMAN PRESCRIPTION DRUG MIRTAZAPINE MIRTAZAPINE TABLET, FILM COATED ORAL 20140101 ANDA ANDA077666 Direct Rx MIRTAZAPINE 45 mg/1 61919-156_76c6df17-d30b-4700-9c24-d4f46d702cba 61919-156 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20140101 ANDA ANDA040355 DIRECT RX ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 61919-157_cc9766ce-86ac-474e-a677-8f979bd194e6 61919-157 HUMAN PRESCRIPTION DRUG RAMIPRIL RAMIPRIL CAPSULE ORAL 20140101 ANDA ANDA077626 DIRECT RX RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 61919-158_688d305b-d829-4589-b7ea-cbed59175e13 61919-158 HUMAN PRESCRIPTION DRUG MUPIROCIN MUPIROCIN OINTMENT TOPICAL 20140101 ANDA ANDA065085 DIRECT RX MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 61919-159_6fabd163-4ab2-4816-93a1-114525e0df0e 61919-159 HUMAN PRESCRIPTION DRUG NABUMETONE NABUMETONE TABLET, FILM COATED ORAL 20140101 ANDA ANDA075189 Direct Rx NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-160_6fabd163-4ab2-4816-93a1-114525e0df0e 61919-160 HUMAN PRESCRIPTION DRUG NABUMETONE NABUMETONE TABLET, FILM COATED ORAL 20140101 ANDA ANDA075189 Direct Rx NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-163_00ea4212-5a70-4851-9a70-d28479320ba6 61919-163 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20140101 ANDA ANDA075927 Direct RX NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-165_80fdbe11-1c8b-473c-8db3-52635dc9c577 61919-165 HUMAN PRESCRIPTION DRUG NAPROXEN SODIUM NAPROXEN SODIUM CAPSULE ORAL 20140101 ANDA ANDA078432 DIRECT RX NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-171_cc3b58e1-2b07-41a3-bbe9-d9a5730ecf3b 61919-171 HUMAN PRESCRIPTION DRUG NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE ORAL 20140101 ANDA ANDA074132 Direct Rx NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 61919-176_a8d282b6-2ff2-49e3-b73b-2e75493aa0ed 61919-176 HUMAN PRESCRIPTION DRUG OMEPRAZOLE DR OMEPRAZOLE DR CAPSULE, DELAYED RELEASE ORAL 20140101 ANDA ANDA076048 Direct Rx OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 61919-177_d8a300b5-0cb3-48a5-89a3-38e0c5b169b3 61919-177 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 20140101 ANDA ANDA040284 Direct RX ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 61919-178_f55e2196-84d1-4a61-addc-faa76445f7c9 61919-178 HUMAN PRESCRIPTION DRUG OXAPROZIN OXAPROZIN TABLET ORAL 20140101 ANDA ANDA075844 DIRECT RX OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-181_83342d80-bea3-4ef9-9e8f-e8e8c16dd13b 61919-181 HUMAN PRESCRIPTION DRUG PAROXETINE HYDROCHLORIDE ANHYDROUS PAROXETINE HYDROCHLORIDE ANHYDROUS TABLET, FILM COATED ORAL 20140101 ANDA ANDA075356 DIRECT RX PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61919-184_a7159cee-cad8-4656-98f0-7c7d2283c467 61919-184 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20140101 UNAPPROVED DRUG OTHER Direct Rx PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 61919-186_5c7c2dfd-868c-4a48-a3cc-9b588c6be6c9 61919-186 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA040555 DIRECT RX PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] 61919-200_3f02a51a-e596-4e90-93de-681698b933e6 61919-200 HUMAN PRESCRIPTION DRUG RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA077824 Direct Rx RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 61919-206_6350ae7f-ff7e-45f7-9c18-7f1cf46ae136 61919-206 HUMAN PRESCRIPTION DRUG SILVER SULFADIAZINE SILVER SULFADAZINE CREAM TOPICAL 20140101 NDA NDA018810 DIRECT RX SILVER SULFADIAZINE 10 mg/g 61919-211_e671438c-307a-4dcc-b088-251cbe393f41 61919-211 HUMAN PRESCRIPTION DRUG MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE ORAL 20140101 ANDA ANDA065470 Direct Rx MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 61919-214_c89a2134-6c1e-4f0e-a973-d4b79ac8a830 61919-214 HUMAN PRESCRIPTION DRUG TEMAZEPAM TEMAZEPAM CAPSULE ORAL 20140101 ANDA ANDA071638 DIRECT RX TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 61919-220_4a7b6b60-98fb-4a7a-8cf9-705d13e97dca 61919-220 HUMAN PRESCRIPTION DRUG TIZANIDINE TIZANIDINE TABLET ORAL 20140101 ANDA ANDA076533 Direct Rx TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 61919-221_4a7b6b60-98fb-4a7a-8cf9-705d13e97dca 61919-221 HUMAN PRESCRIPTION DRUG TIZANIDINE TIZANIDINE TABLET ORAL 20140101 ANDA ANDA076533 Direct Rx TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 61919-224_fba731dc-a021-46ec-a4a7-cfb26c812be0 61919-224 HUMAN PRESCRIPTION DRUG TOBRAMYCIN TOBRAMYCIN SOLUTION OPHTHALMIC 20140101 ANDA ANDA064052 Direct Rx TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 61919-229_2ec13a0d-d67c-490d-b085-dc1f84c72f2c 61919-229 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA075964 Direct Rx TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 61919-231_d742bff9-9f5e-4231-983b-433907155a3a 61919-231 HUMAN PRESCRIPTION DRUG TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA071523 DIRECT RX TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 61919-232_2d6fb240-5961-426c-858f-16035cd62141 61919-232 HUMAN PRESCRIPTION DRUG TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA071523 DIRECT RX TRAZODONE HYDROCHLORIDE 100 1/1 Serotonin Reuptake Inhibitor [EPC] 61919-256_b4a82fc2-aa96-4911-88f5-9d495538d224 61919-256 HUMAN PRESCRIPTION DRUG ATENOLOL ATENOLOL TABLET ORAL 20140101 ANDA ANDA077877 DIRECT RX ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 61919-257_2a451614-6b71-40bf-9e10-902d7899cda4 61919-257 HUMAN PRESCRIPTION DRUG ATENOLOL ATENOLOL TABLET ORAL 20140101 ANDA ANDA077877 Direct Rx ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 61919-266_679b5f11-23fb-4801-8273-2c4085f73995 61919-266 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA070974 DIRECT RX CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 61919-281_f9a72240-6ace-4dd6-ac5f-1b94dee22bc7 61919-281 HUMAN PRESCRIPTION DRUG FAMOTIDINE FAMOTIDINE TABLET ORAL 20140101 ANDA ANDA075805 Direct Rx FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 61919-286_89f64b49-04a4-4081-8f0d-18695ec0de1f 61919-286 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20140101 ANDA ANDA077820 DIRECT RX GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 61919-291_cf2575c8-9b9d-4870-a54b-210998b769e5 61919-291 HUMAN PRESCRIPTION DRUG PREDNISOLONE PREDNISOLONE SOLUTION ORAL 20140101 ANDA ANDA040401 DIRECT RX PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61919-293_021996d7-6d2e-401a-9948-edc2a5f0a2dc 61919-293 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 20140101 ANDA ANDA040907 DIRECT RX HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 61919-295_ebea34b2-aae6-4baf-96c3-d8004816ef45 61919-295 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20140101 ANDA ANDA077955 Direct Rx AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 61919-296_d74feca3-62b5-4221-9847-eaceea240a8c 61919-296 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET, COATED ORAL 20140101 ANDA ANDA077723 DIRECT RX HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-308_e5b2a244-9269-4c67-8669-c1ed2d103c4a 61919-308 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20140101 ANDA ANDA077912 DIRECT RX HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 61919-309_17244f22-cf1b-4633-86cb-20d76fc1b864 61919-309 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20140101 ANDA ANDA077912 DIRECT RX HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 61919-311_a7182eb7-c3bd-48f7-bd29-b8467979e78b 61919-311 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20140101 ANDA ANDA078296 Direct Rx LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 61919-317_63b1de6d-1cc5-4290-a751-3d663f2da375 61919-317 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET ORAL 20140101 ANDA ANDA074644 DIRECT RX METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 61919-320_8347bda4-02d6-4f9e-8e1a-ba1868cd6baa 61919-320 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET ORAL 20140101 ANDA ANDA078154 DIRECT RX LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 61919-322_e515e31c-c5d8-4c75-a3c6-e60032f76a63 61919-322 HUMAN PRESCRIPTION DRUG PAROXETINE PAROXETINE TABLET, FILM COATED ORAL 20140101 ANDA ANDA075356 DIRECT RX PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61919-326_1c777f41-aa31-4c4c-baf8-5e5fba0455f1 61919-326 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20140101 ANDA ANDA080356 DIRECT RX PREDNISONE 20 mg/1 61919-346_7cb1a850-95ad-405f-9dfa-f9af5bfecfa1 61919-346 HUMAN PRESCRIPTION DRUG METAXALONE METAXALONE TABLET ORAL 20140101 NDA NDA013217 DIRECT RX METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 61919-357_7ec48d18-214a-4b72-8aa1-6f47ff2fe4ea 61919-357 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20140101 ANDA ANDA088496 Direct Rx HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 61919-362_995a413c-3353-43fd-b4af-8675b9b79260 61919-362 HUMAN PRESCRIPTION DRUG AZITHROMYCIN DIHYDRATE AZITHROMYCIN DIHYDRATE TABLET, FILM COATED ORAL 20140101 ANDA ANDA065507 DIRECT RX AZITHROMYCIN DIHYDRATE 250 1/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 61919-364_f458a785-2285-48ea-83e4-c8a7035a64c1 61919-364 HUMAN PRESCRIPTION DRUG HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 20140101 ANDA ANDA088799 DIRECT RX HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61919-365_e4692217-aca0-4a75-9fe0-eaeb716afb79 61919-365 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20140101 ANDA ANDA040584 DIRECT RX PREDNISONE 5 mg/1 61919-370_94797373-3bdf-4377-91bb-e65169a84dbd 61919-370 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR TABLET ORAL 20140101 ANDA ANDA075382 Direct RX ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 61919-371_1f011978-3f6e-4c48-a76a-8da52d0672d6 61919-371 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN TABLET ORAL 20140101 ANDA ANDA076639 Direct Rx CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 61919-373_b397855d-79a5-4555-bc70-33ebdc542bb0 61919-373 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140101 ANDA ANDA080292 Direct Rx PREDNISONE 5 mg/1 61919-382_2ea82fce-7d6a-4835-9c8e-0f4c3fde53a0 61919-382 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN POWDER, FOR SUSPENSION ORAL 20140101 ANDA ANDA065246 DIRECT RX AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 61919-397_0b2a462a-e50a-41fb-b41d-52d92e400d39 61919-397 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA090564 Direct Rx METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 61919-401_a6311ef5-f54c-4ab6-afb5-529108464aed 61919-401 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN POWDER, FOR SUSPENSION ORAL 20140101 ANDA ANDA065334 DIRECT RX AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 61919-404_b397855d-79a5-4555-bc70-33ebdc542bb0 61919-404 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20140101 ANDA ANDA088832 Direct Rx PREDNISONE 10 mg/1 61919-416_a1e4b322-694a-4926-b18b-058bd2316dd4 61919-416 HUMAN PRESCRIPTION DRUG SERTRALINE SERTRALINE TABLET ORAL 20140101 ANDA ANDA077397 DIRECT RX SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61919-421_161d9e40-29f8-484e-bc7c-99c43d83cea1 61919-421 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN SOLUTION/ DROPS TOPICAL 20140101 ANDA ANDA077689 Direct Rx CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 61919-424_da21fdf0-1ef9-47e1-8b0a-c4733bcdba37 61919-424 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN CAPSULE ORAL 20140101 ANDA ANDA061926 DIRECT RX AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 61919-431_5176198e-b09a-41d5-a8a8-e10dbae1f0a8 61919-431 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20140101 ANDA ANDA078155 DIRECT RX SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 61919-434_01d583f7-e5b2-46c6-80d6-17ab1eb00d6c 61919-434 HUMAN PRESCRIPTION DRUG MELOXICAM MELOXICAM TABLET ORAL 20140101 ANDA ANDA077927 Direct Rx MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-435_cc3b58e1-2b07-41a3-bbe9-d9a5730ecf3b 61919-435 HUMAN PRESCRIPTION DRUG NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE ORAL 20140101 ANDA ANDA074132 Direct Rx NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 61919-438_0bbb1abf-5b62-4ad0-a79b-89a9e87f63d4 61919-438 HUMAN PRESCRIPTION DRUG TEMAZEPAM TEMAZEPAM CAPSULE ORAL 20140101 ANDA ANDA071620 Direct Rx TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 61919-441_fcefc0fa-c234-4648-a74e-8bac2613df6a 61919-441 HUMAN PRESCRIPTION DRUG CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE ORAL 20140101 ANDA ANDA065061 DIRECT RX CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 61919-442_f1d54fa2-9087-4604-aac5-a5e264e9d086 61919-442 HUMAN PRESCRIPTION DRUG FUROSEMIDE FUROSEMIDE TABLET ORAL 20140101 ANDA ANDA076796 DIRECT RX FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 61919-443_575b3d41-6657-4479-84fc-d3632265a8ce 61919-443 HUMAN PRESCRIPTION DRUG LIDOCAINE AND PRILOCAINE LIDOCAINE AND PRILOCAINE CREAM TOPICAL 20140101 NDA NDA019941 DIRECT RX LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 61919-445_2ededcbd-a008-4d55-b066-9c696811c19d 61919-445 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140101 NDA NDA018279 DIRECT RX POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 61919-446_118820ce-7beb-4e2d-9e98-7d53b697d551 61919-446 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20140101 ANDA ANDA078155 Direct Rx SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 61919-457_a1e4b322-694a-4926-b18b-058bd2316dd4 61919-457 HUMAN PRESCRIPTION DRUG SERTRALINE SERTRALINE TABLET ORAL 20140101 ANDA ANDA077397 DIRECT RX SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61919-459_c58521b9-95ef-44d5-a9e9-94e5a9de115b 61919-459 HUMAN OTC DRUG DOCUSATE SODIUM DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140101 OTC MONOGRAPH NOT FINAL part334 DIRECT RX DOCUSATE SODIUM 100 mg/1 61919-460_bf9bdaa9-a235-4067-afa1-b7cb7edc178f 61919-460 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20140101 ANDA ANDA078414 DIRECT RX AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 61919-464_c3450f3c-b6dc-4d3a-a517-3ceed3d2c54d 61919-464 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20140101 ANDA ANDA077851 DIRECT RX ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 61919-465_6e6aeb02-ebe0-41b1-8fd3-7a7f76a0b98e 61919-465 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20140101 ANDA ANDA077851 DIRECT RX ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 61919-469_01d583f7-e5b2-46c6-80d6-17ab1eb00d6c 61919-469 HUMAN PRESCRIPTION DRUG MELOXICAM MELOXICAM TABLET ORAL 20140101 ANDA ANDA077927 Direct Rx MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-478_85fb1412-7f54-471e-a543-006826cdd770 61919-478 HUMAN PRESCRIPTION DRUG CHLORZOXAZONE CHLORZOXAZONE TABLET ORAL 20140101 ANDA ANDA089859 DIRECT RX CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 61919-480_a0b1ad02-6f29-402f-9581-d2854cb1011e 61919-480 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET ORAL 20140101 ANDA ANDA077032 DIRECT RX CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61919-481_1c7b2872-6e92-4d4e-818e-3d9f5b59e4c2 61919-481 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20140101 ANDA ANDA074869 DIRECT RX CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 61919-483_b6203999-d6a1-4f94-8ee3-f86d6a800ad1 61919-483 HUMAN PRESCRIPTION DRUG DULOXETINE DULOXETINE CAPSULE, DELAYED RELEASE ORAL 20140101 ANDA ANDA090745 DIRECT RX DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61919-492_a2f34ad3-e6d8-4cc7-9ab0-7a7c19337f3f 61919-492 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20140101 ANDA ANDA077242 Direct Rx GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 61919-494_d77f7cae-a54f-4ef3-b7c3-819c9e7afaea 61919-494 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET ORAL 20140101 ANDA ANDA040736 DIRECT RX ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 61919-500_1af9b5a8-78ca-4561-bd98-226579c47ad6 61919-500 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140101 ANDA ANDA091103 Direct Rx ESZOPICLONE 3 mg/1 61919-503_6b2cd341-e3b4-4147-9329-40e40461a1c4 61919-503 HUMAN PRESCRIPTION DRUG PREGABALIN PREGABALIN CAPSULE ORAL 20140101 NDA NDA021446 DIRECT RX PREGABALIN 50 mg/1 61919-506_9f3b46a9-c934-4df1-9536-c896d2b7f180 61919-506 HUMAN PRESCRIPTION DRUG PREGABALIN PREGABALIN CAPSULE ORAL 20140101 ANDA ANDA021446 DIRECT RX PREGABALIN 150 mg/1 61919-518_70c94388-a10a-47ae-a773-a1a0d4393453 61919-518 HUMAN OTC DRUG DOCUSATE SODIUM AND SENNA DOCUSATE SODIUM AND SENNA TABLET, FILM COATED ORAL 20140101 OTC MONOGRAPH NOT FINAL part334 DIRECT RX DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 61919-528_187a5208-35eb-4d76-bad5-5fba09f1e955 61919-528 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, FILM COATED ORAL 20140101 ANDA ANDA078616 DIRECT RX ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] 61919-533_a780bdc4-55cf-4bee-b0ab-4778dcbac42a 61919-533 HUMAN PRESCRIPTION DRUG CARVEDILOL CARVEDILOL TABLET, FILM COATED ORAL 20140101 ANDA ANDA078384 DIRECT RX CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 61919-535_d36af3d6-4936-44ed-9b91-d310c8686a6a 61919-535 HUMAN PRESCRIPTION DRUG VENLAFAXINE VENLAFAXINE TABLET ORAL 20140101 ANDA ANDA078554 Direct Rx VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61919-539_fa0d0c91-aa67-488e-9e80-fe086db6d43b 61919-539 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20140101 ANDA ANDA077869 DIRECT RX ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 61919-545_0a6671ef-6e04-435c-b668-d6ee097a1a67 61919-545 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20140101 ANDA ANDA090469 DIRECT RX ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 61919-547_b79c46a6-9653-4067-a837-993deebc0920 61919-547 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20140101 ANDA ANDA075991 DIRECT RX LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 61919-560_799fd9f2-5730-4b25-9e30-1dfb36afbbaf 61919-560 HUMAN PRESCRIPTION DRUG MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE ORAL 20140101 ANDA ANDA065470 Direct Rx MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 61919-567_7bf186f8-cdcb-4042-b337-169c9a1cacb4 61919-567 HUMAN PRESCRIPTION DRUG DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE ORAL 20140101 ANDA ANDA070791 DIRECT RX DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 61919-579_68d010c7-85dc-4f17-8947-b567414f8d12 61919-579 HUMAN PRESCRIPTION DRUG BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA075022 Direct Rx BUSPIRONE HYDROCHLORIDE 15 mg/1 61919-585_bdfc801f-e7af-402f-99eb-1a207665f169 61919-585 HUMAN PRESCRIPTION DRUG TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA071525 Direct Rx TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 61919-589_88aceb09-bc70-4cad-9295-c7f7b61ca9d9 61919-589 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140101 ANDA ANDA077284 Direct Rx BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 61919-592_4bb40515-830c-4e45-9e55-5b400cc42018 61919-592 HUMAN PRESCRIPTION DRUG VOLTAREN VOLTAREN GEL TOPICAL 20140101 NDA NDA022122 DIRECT RX DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 61919-629_b667293b-2b32-4704-8b27-abbf1ab7e666 61919-629 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20140101 ANDA ANDA078989 DIRECT RX ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] 61919-644_51e27c02-559c-408f-bd7e-e2a58d425185 61919-644 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA078554 DIRECT RX VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 61919-773_a8d282b6-2ff2-49e3-b73b-2e75493aa0ed 61919-773 HUMAN PRESCRIPTION DRUG OMEPRAZOLE DR OMEPRAZOLE DR CAPSULE, DELAYED RELEASE ORAL 20140101 ANDA ANDA076048 Direct Rx OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 61919-817_d36442fd-98c7-4dd1-94a4-d5ad5051c05d 61919-817 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20140101 ANDA ANDA090278 DIRECT RX TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 61919-824_139cb590-a2d6-4c3c-a3f8-43e40ed87a8d 61919-824 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20140101 ANDA ANDA090278 DIRECT RX TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 61919-825_af063cd8-f7ff-457d-b57f-da7949206cc4 61919-825 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET ORAL 20140101 ANDA ANDA079153 DIRECT RX TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 61919-841_3c0b06f9-8172-4cf5-bc6b-497817e8652d 61919-841 HUMAN PRESCRIPTION DRUG KETOCONAZOLE KETOCONAZOLE CREAM TOPICAL 20140101 ANDA ANDA076294 DIRECT RX KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 61919-867_9a6aeda8-6317-42e0-b10a-f8934014746d 61919-867 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20140101 ANDA ANDA076361 Direct RX LEVOFLOXACIN 750 mg/1 61919-890_672e3642-72b1-429f-868b-ca8937bb22c0 61919-890 HUMAN PRESCRIPTION DRUG LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140101 ANDA ANDA202366 Direct RX LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 61919-930_1a32501a-0203-45a8-ad77-6913356cc52c 61919-930 HUMAN PRESCRIPTION DRUG FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE CREAM TOPICAL 20140101 ANDA ANDA077055 DIRECT RX FLUTICASONE PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 61919-952_de4c1809-1781-43b9-b9d9-bc3671d3d05a 61919-952 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET ORAL 20140101 ANDA ANDA090467 DIRECT RX LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 61919-953_af8cdbf5-7423-4aea-88e9-49d3b81fbb3b 61919-953 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140101 NDA NDA018279 DIRECT RX POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 61919-954_40191edf-08b5-4ac4-b813-2215b02c98f5 61919-954 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET ORAL 20140101 ANDA ANDA090528 DIRECT RX HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 61919-986_b316c5e1-4495-43c1-9509-4b29333e434d 61919-986 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20140101 ANDA ANDA090469 Direct Rx ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 61919-987_d17f216e-d675-4b2e-9664-1442eb8bb43a 61919-987 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET, FILM COATED ORAL 20140101 ANDA ANDA201043 DIRECT RX LEVOFLOXACIN 250 mg/1 61919-989_a34f4e23-7178-4aa0-a099-73941c700257 61919-989 HUMAN PRESCRIPTION DRUG AK-POLY-BAC AK-POLY-BAC OINTMENT OPHTHALMIC 20140101 ANDA ANDA064028 DIRECT RX BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 g/1; g/1 Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 61919-992_9a6aeda8-6317-42e0-b10a-f8934014746d 61919-992 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20140101 ANDA ANDA076361 Direct RX LEVOFLOXACIN 500 mg/1 61924-092_a83cc35a-bd62-4568-92f0-bd6503db14ef 61924-092 HUMAN OTC DRUG DERMAKLEEN ANTIMICROBIAL DRUG PRODUCT SOAP TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333A Dermarite Industries LLC CHLOROXYLENOL .002 g/mL 61924-093_fce71fa0-5bed-4600-a7bd-00e71ffd730a 61924-093 HUMAN OTC DRUG KLEENFOAM OTC ANTIMICROBIAL DRUG PRODUCT AEROSOL, FOAM TOPICAL 20111212 OTC MONOGRAPH NOT FINAL part333A Dermarite Industries LLC CHLOROXYLENOL .005 g/mL 61924-102_30652617-1c94-4b05-90b3-f952a17b7572 61924-102 HUMAN OTC DRUG HAND-E-FOAM OTC ANTIMICROBIAL DRUG PRODUCTS AEROSOL, FOAM TOPICAL 20020808 OTC MONOGRAPH NOT FINAL part333A DermaRite Industries, LLC BENZETHONIUM CHLORIDE .002 g/mL 61924-107_89ed3c42-e05b-44a8-95b5-aa3fee0bee55 61924-107 HUMAN OTC DRUG SAN-E-FOAM OTC ANTIMICROBIAL DRUG PRODUCTS AEROSOL, FOAM TOPICAL 20121012 OTC MONOGRAPH NOT FINAL part333A Dermarite Industries LLC ALCOHOL .67 g/mL 61924-188_274f00be-d796-4874-93d8-5c0e24fd551e 61924-188 HUMAN OTC DRUG DERMASARRA OTC TOPICAL ANALGESIC DRUG PRODUCTS LOTION TOPICAL 20100224 OTC MONOGRAPH NOT FINAL part348 DERMARITE INDUSTRIES, LLC CAMPHOR (NATURAL); MENTHOL .005; .005 g/mL; g/mL 61924-198_794b3bb1-ca08-4e28-8bbe-7f0a4eaa4f86 61924-198 HUMAN OTC DRUG PERIGIENE ANTIMICROBIAL DRUG PRODUCT SOAP TOPICAL 20111212 OTC MONOGRAPH NOT FINAL part333A Dermarite Industries LLC CHLOROXYLENOL .005 g/mL 61924-204_3da1e7a2-bab5-49bb-b1af-e48a4acceb70 61924-204 HUMAN OTC DRUG PERIGUARD OTC Skin Protectant Drug Products OINTMENT TOPICAL 20110418 OTC MONOGRAPH FINAL part347 DermaRite Industries, LLC ZINC OXIDE .038 g/g 61924-208_efc8102b-5d60-45b3-ae80-f1af266756f9 61924-208 HUMAN OTC DRUG 4-N-1 WASH OTC SKIN PROTECTANT DRUG PRODUCT CREAM TOPICAL 20100102 OTC MONOGRAPH FINAL part347 DermaRite Industries, LLC DIMETHICONE .01 g/g 61924-212_3dac5e4b-d7d3-4119-88e6-050362d9aad0 61924-212 HUMAN OTC DRUG DERMASEPTIN OTC SKIN PROTECTANT DRUG PRODUCTS OINTMENT TOPICAL 20101025 OTC MONOGRAPH FINAL part347 DermaRite Industries, LLC MENTHOL; ZINC OXIDE .005; .005 g/g; g/g 61924-232_153f29ab-f292-433a-8469-845ea185d07a 61924-232 HUMAN OTC DRUG Lanoderm OTC Skin Protectant Drug Products OINTMENT TOPICAL 20120416 OTC MONOGRAPH FINAL part347 Dermarite Industries LLC LANOLIN .3 g/100g 61924-234_88adb3ed-8624-4e11-9af9-6cb6e3e1b24e 61924-234 HUMAN OTC DRUG DERMAGUNGAL ANTIMICROBIAL DRUG PRODUCTS CREAM TOPICAL 20051212 OTC MONOGRAPH FINAL part333C DermaRite industries, LLC MICONAZOLE NITRATE .02 g/100g 61924-266_371b42b3-156c-4e31-9b3c-03c71a1c138a 61924-266 HUMAN OTC DRUG UTRASURE OTC ANTIPRESPIRANT DRUG PRODUCT SPRAY TOPICAL 20100224 OTC MONOGRAPH FINAL part350 DermaRite Industries LLC ALUMINUM SESQUICHLOROHYDRATE .15 g/100mL 61924-405_6f56ad13-50ac-4030-b197-41dca375c491 61924-405 HUMAN OTC DRUG RENEW SKIN REPAIR OTC SKIN PROTECTANT DRUG PRODUCTS CREAM TOPICAL 20110303 OTC MONOGRAPH FINAL part347 Dermarite Industries LLC DIMETHICONE .015 g/100g 61924-410_3e855b4e-ede6-4ca2-ae8f-df5cb30a3bca 61924-410 HUMAN OTC DRUG Renew Dimethicone Skin Protectant Skin Protectant CREAM TOPICAL 20120315 OTC MONOGRAPH FINAL part347 Dermarite Industries LLC DIMETHICONE .05 g/100g 61924-430_31905b37-ce7f-4600-b069-d77c9b043151 61924-430 HUMAN OTC DRUG RENEW BODY CLEANSER OTC SKIN PROTECTANT DRUG PRODUCTS LOTION TOPICAL 20120302 OTC MONOGRAPH FINAL part347 DermaRite Industries, LLC DIMETHICONE .01 g/g 61935-001_00c5c9c2-30f4-4754-a04f-3cd6ee1482da 61935-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980114 UNAPPROVED MEDICAL GAS Centura Home Oxygen OXYGEN 995 mL/L 61938-456_d37c02fb-1bed-4400-92d2-50a67e539beb 61938-456 HUMAN PRESCRIPTION DRUG INFASURF CALFACTANT SUSPENSION ENDOTRACHEAL 20110721 NDA NDA020521 Ony, Inc. CALFACTANT 35.7 mg/mL Alveolar Surface Tension Reduction [PE],Surfactant [EPC],Surfactant Activity [MoA] 61941-0011_716275c2-7e41-4cce-b792-91d65ad32127 61941-0011 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 19940607 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0012_716275c2-7e41-4cce-b792-91d65ad32127 61941-0012 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 19940607 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0021_302a8a5e-b5d2-4820-a3b4-fc83310cb114 61941-0021 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 19940607 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0022_302a8a5e-b5d2-4820-a3b4-fc83310cb114 61941-0022 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 19940607 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0031_716275c2-7e41-4cce-b792-91d65ad32127 61941-0031 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20030201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0032_716275c2-7e41-4cce-b792-91d65ad32127 61941-0032 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20030201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0041_716275c2-7e41-4cce-b792-91d65ad32127 61941-0041 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20030201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0042_716275c2-7e41-4cce-b792-91d65ad32127 61941-0042 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20030201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0051_716275c2-7e41-4cce-b792-91d65ad32127 61941-0051 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20030201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0052_716275c2-7e41-4cce-b792-91d65ad32127 61941-0052 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20030201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0071_716275c2-7e41-4cce-b792-91d65ad32127 61941-0071 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20100201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0072_716275c2-7e41-4cce-b792-91d65ad32127 61941-0072 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20100201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0081_28f7f321-29f9-4a2e-a21f-6d2420eb755c 61941-0081 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20050201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0082_28f7f321-29f9-4a2e-a21f-6d2420eb755c 61941-0082 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20050201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0091_28f7f321-29f9-4a2e-a21f-6d2420eb755c 61941-0091 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20050201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0092_28f7f321-29f9-4a2e-a21f-6d2420eb755c 61941-0092 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20050201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0101_28f7f321-29f9-4a2e-a21f-6d2420eb755c 61941-0101 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20050201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0102_28f7f321-29f9-4a2e-a21f-6d2420eb755c 61941-0102 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20050201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0111_9df15ad0-033c-413e-9e3a-0124c8c2b620 61941-0111 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20030201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 61941-0122_04f96bd9-bf04-4cb8-b021-c38db949f1de 61941-0122 HUMAN OTC DRUG Organix Complete Menthol and Pectin LOZENGE ORAL 20101101 OTC MONOGRAPH FINAL part341 ProPhase Labs, Inc. MENTHOL; PECTIN 2.5; 1.7 mg/1; mg/1 61941-0132_f5c05aa5-6b4c-4a6c-ba9b-2fe1cc8bce03 61941-0132 HUMAN OTC DRUG Organix Complete Menthol and Pectin LOZENGE ORAL 20101101 OTC MONOGRAPH FINAL part341 ProPhase Labs, Inc. MENTHOL; PECTIN 2.5; 1.7 mg/1; mg/1 61941-0217_dbdde3f1-9364-47b6-aac0-d53b43d0a177 61941-0217 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate SPRAY ORAL 20110801 20190331 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/.5mL 61941-0223_8c9e0e83-058b-4f5a-899f-03a0f80033c0 61941-0223 HUMAN OTC DRUG Cold-EEZE PLUS Immune Support Zinc Gluconate, ROSA CANINA LEAF, and ECHINACEA PURPUREA TABLET, ORALLY DISINTEGRATING ORAL 20130901 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ECHINACEA PURPUREA; ROSA CANINA LEAF; ZINC GLUCONATE 2; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 61941-0224_77929b78-95c9-4d7e-a2ac-3de5fb40d5c4 61941-0224 HUMAN OTC DRUG Cold-EEZE Plus Immune Support Plus Energy ZINC GLUCONATE, ROSA CANINA LEAF, ECHINACEA PURPUREA, CAFFEINE, and PANAX NOTOGINSENG ROOT TABLET, ORALLY DISINTEGRATING ORAL 20130901 20230831 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. CAFFEINE; ECHINACEA PURPUREA; PANAX NOTOGINSENG ROOT; ROSA CANINA LEAF; ZINC GLUCONATE 1; 2; 2; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 61941-0227_dbdde3f1-9364-47b6-aac0-d53b43d0a177 61941-0227 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate SPRAY ORAL 20110801 20190331 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/.5mL 61941-1002_4f391211-f806-4c0f-887b-d32759754a49 61941-1002 HUMAN OTC DRUG Kids-EEZE Chest Relief Guaifenesin TABLET, ORALLY DISINTEGRATING ORAL 20080901 OTC MONOGRAPH FINAL part341 ProPhase Labs, Inc. GUAIFENESIN 100 mg/1 61941-1003_cb36368e-90be-4280-a39e-b83b854645c8 61941-1003 HUMAN OTC DRUG Kids-EEZE Cough and Cold Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20100901 OTC MONOGRAPH FINAL part341 ProPhase Labs, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/1; mg/1 61941-1005_185301e7-69c9-43ef-93c1-e6dddeb153ad 61941-1005 HUMAN OTC DRUG Kids-EEZE Allergy Diphenhydramine Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20100901 OTC MONOGRAPH FINAL part341 ProPhase Labs, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 61953-0001_fa53d149-fe43-49b1-b683-6de921628fc2 61953-0001 PLASMA DERIVATIVE Human Albumin Grifols Albumin (Human) SOLUTION INTRAVENOUS 19950217 BLA BLA103352 GRIFOLS USA, LLC ALBUMIN (HUMAN) 10 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 61953-0002_85057568-78ad-4e30-b443-2136c5b46c71 61953-0002 PLASMA DERIVATIVE Human Albumin Grifols Albumin (Human) SOLUTION INTRAVENOUS 20030611 BLA BLA103352 GRIFOLS USA, LLC ALBUMIN (HUMAN) 12.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 61953-0004_4538206e-8a47-4bbd-aae8-f0584c39ab22 61953-0004 PLASMA DERIVATIVE Flebogamma DIF HUMAN IMMUNOGLOBULIN G INJECTION, SOLUTION INTRAVENOUS 20061221 BLA BLA125077 GRIFOLS USA, LLC HUMAN IMMUNOGLOBULIN G .05 g/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 61953-0005_b8c763dd-4eb8-4638-881a-059c82557a80 61953-0005 PLASMA DERIVATIVE Flebogamma DIF Human Immunoglobulin G INJECTION, SOLUTION INTRAVENOUS 20100727 BLA BLA125077 GRIFOLS USA, LLC HUMAN IMMUNOGLOBULIN G 5 g/50mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 61957-0001_da62f589-3d50-45ec-9cf4-945d2590324c 61957-0001 HUMAN OTC DRUG CD DiorSnow UV Protection BB Eye Sunscreen Creme 010 TITANIUM DIOXIDE CREAM TOPICAL 20120910 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 3.65 mL/100mL 61957-0002_c9d3db63-7c50-4908-ac0e-dd11c5b29d7c 61957-0002 HUMAN OTC DRUG CD DiorSnow UV Protection BB Eye Sunscreen Creme 020 TITANIUM DIOXIDE CREAM TOPICAL 20120910 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 3.65 mL/100mL 61957-0003_e92eeaea-38c8-4138-80c1-d0e17ffeabe3 61957-0003 HUMAN OTC DRUG DIORSKIN NUDE TAN BB CREME HEALTHY GLOW SKIN-PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF15 Tint 1 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20130124 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 21.9 mg/mL; mg/mL 61957-0004_846e1455-d1d9-42a0-abdd-0cd0c3176cf9 61957-0004 HUMAN OTC DRUG DIORSKIN NUDE TAN BB CREME HEALTHY GLOW SKIN-PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF15 Tint 2 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 21.9 mg/mL; mg/mL 61957-0005_806ee45f-3842-4de2-928f-cd661eb883fd 61957-0005 HUMAN OTC DRUG DIORSKIN NUDE BB CREME NUDE GLOW SKIN-PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF10 Tint 1 TITANIUM DIOXIDE CREAM TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 21.9 mg/mL 61957-0006_2d42310e-420a-4ee5-91ed-054e54066202 61957-0006 HUMAN OTC DRUG DIORSKIN NUDE BB CREME NUDE GLOW SKIN-PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF10 Tint 2 TITANIUM DIOXIDE CREAM TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 21.9 mg/mL 61957-0007_2535e919-10a5-4105-8d1f-478949f416f2 61957-0007 HUMAN OTC DRUG DIORSKIN NUDE BB CREME NUDE GLOW SKIN-PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF10 Tint 3 TITANIUM DIOXIDE CREAM TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 21.9 mg/mL 61957-0008_d6c5369e-5352-4f3d-b418-5badfd474103 61957-0008 HUMAN OTC DRUG DIORSKIN NUDE BB CREME NUDE GLOW SKIN-PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF10 Tint 4 TITANIUM DIOXIDE CREAM TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 21.9 mg/mL 61957-0010_fcbfd5ed-ae96-4001-8240-c5f76f6dd8c6 61957-0010 HUMAN OTC DRUG DiorSkin Nude 010 Ivory TITANIUM DIOXIDE POWDER TOPICAL 20100616 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 5.53 g/100g 61957-0020_8389aa86-7cda-40da-aa77-099c46be09a1 61957-0020 HUMAN OTC DRUG DiorSkin Nude 020 Light Beige TITANIUM DIOXIDE POWDER TOPICAL 20100616 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 5.53 g/100g 61957-0022_eab2dcb7-0033-4dec-aa1e-2604dbeef371 61957-0022 HUMAN OTC DRUG DiorSkin Nude 022 Cameo TITANIUM DIOXIDE POWDER TOPICAL 20100616 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 5.53 g/100g 61957-0030_bbc690a3-5681-4797-a40e-18daeb2ffce8 61957-0030 HUMAN OTC DRUG DiorSkin Nude 030 Medium Beige TITANIUM DIOXIDE POWDER TOPICAL 20100616 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 5.53 g/100g 61957-0040_516b9d09-7ae4-4bb8-8df5-b18cedfe91a6 61957-0040 HUMAN OTC DRUG DiorSkin Nude 040 Honey Beige TITANIUM DIOXIDE POWDER TOPICAL 20100616 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 5.53 g/100g 61957-0050_3d0d6ac1-f759-4243-a5bc-c4c2d06fcce5 61957-0050 HUMAN OTC DRUG DiorSkin Nude 050 Dark Beige TITANIUM DIOXIDE POWDER TOPICAL 20100616 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 5.53 g/100g 61957-0052_f79ef1d6-3b4e-4cdf-8c8a-b9d3a93d0db6 61957-0052 HUMAN OTC DRUG DiorSkin Nude 052 Rosy Bronze TITANIUM DIOXIDE POWDER TOPICAL 20100616 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 5.53 g/100g 61957-0070_998d98d4-daf0-4041-937c-a556637d7658 61957-0070 HUMAN OTC DRUG DiorSkin Nude 070 Dark Brown TITANIUM DIOXIDE POWDER TOPICAL 20100616 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 5.53 g/100g 61957-0101_e79164a3-1b42-4268-a181-04c647a34a85 61957-0101 HUMAN OTC DRUG Dior Bronze Collagen Activ SPF 15 001 OXYBENZONE, OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20101123 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 6; 2; 2.43 g/100g; g/100g; g/100g 61957-0102_51c9a1b1-eecd-4675-b6e6-f78721dffadf 61957-0102 HUMAN OTC DRUG Dior Bronze Collagen Activ SPF 15 002 OXYBENZONE, OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20101123 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 6; 2; 2.43 g/100g; g/100g; g/100g 61957-0103_38cc4b60-a4c6-43c0-a1e7-d1a157336169 61957-0103 HUMAN OTC DRUG Dior Bronze Collagen Activ SPF 15 003 OXYBENZONE, OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20101123 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 6; 2; 2.43 g/100g; g/100g; g/100g 61957-0104_58762b0b-bfe7-4518-b0ea-ed90631d5b59 61957-0104 HUMAN OTC DRUG Dior Bronze Collagen Activ SPF 15 004 OXYBENZONE, OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20101123 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 6; 2; 2.43 g/100g; g/100g; g/100g 61957-0110_e71117b9-48cc-46f4-8e55-1a1b9b95a14b 61957-0110 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 010 Ivory OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mL/100mL; mL/100mL 61957-0111_8e488fce-3168-4e32-b3a7-91ccb598a31d 61957-0111 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 011 Cream OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mL/100mL; mL/100mL 61957-0112_8f9e9996-8b8b-40ab-a18c-c67dfe1a643d 61957-0112 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 020 Light Beige OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mL/100mL; mL/100mL 61957-0113_1acf849c-fea5-4676-9038-0fcf155bdcc9 61957-0113 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 021 Linen OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mL/100mL; mL/100mL 61957-0114_1809bf4d-468b-41e1-b162-ec8210ca9f04 61957-0114 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 022 Cameo OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mL/100mL; mL/100mL 61957-0115_de6bb7c7-f97f-4e9b-8988-e58bded9762e 61957-0115 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 023 Peach OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mL/100mL; mL/100mL 61957-0116_19b5527d-73c6-43b7-8cf8-8b08ac67fa4f 61957-0116 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 030 Medium Beige OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mL/100mL; mL/100mL 61957-0117_fbda3b22-37b7-4ab9-a0e6-585105615a78 61957-0117 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 031 Sand OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mL/100mL; mL/100mL 61957-0118_1d0d51c7-41c7-49e6-bbd1-0bbce4f8100b 61957-0118 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 033 Apricot Beige OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mL/100mL; mL/100mL 61957-0119_8777feba-bd25-4507-8ac3-bdbb17ddb4cb 61957-0119 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 040 Honey Beige OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mL/100mL; mL/100mL 61957-0120_9b0073bd-67cf-4de4-a3ec-1baa621150da 61957-0120 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 041 Ochre OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mL/100mL; mL/100mL 61957-0121_d05a211a-a728-4a0c-98c9-21b30b8d4142 61957-0121 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 050 Dark Beige OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mL/100mL; mL/100mL 61957-0122_3321f151-cb9b-4e59-9999-8c87e346f9a2 61957-0122 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 060 Mocha OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mL/100mL; mL/100mL 61957-0123_2d1a780f-bc59-46e4-bf42-e505c1450311 61957-0123 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 063 Amber OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mL/100mL; mL/100mL 61957-0124_7082e493-2292-4c0e-b97e-bc9882c2d547 61957-0124 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 070 Dark Brown OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mL/100mL; mL/100mL 61957-0201_2f0bf10d-82b6-4427-ba1e-bcefbb7d548e 61957-0201 HUMAN OTC DRUG CD DiorSkin Radiant Base Skin-Refining Pro Lighting - 001 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20110722 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 4.74 mL/100mL; mL/100mL 61957-0202_21aa8bf8-bd3e-4343-a390-7065a5216eaf 61957-0202 HUMAN OTC DRUG CD DiorSkin Radiant Base Skin-Refining Pro Lighting - 002 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20110722 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 4.74 mL/100mL; mL/100mL 61957-0310_31384263-5900-46f6-9539-9093880837e5 61957-0310 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 010 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL 61957-0311_0f9babc6-a58f-4a99-8c2d-afd975ff11d1 61957-0311 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 011 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL 61957-0320_abb41c47-708d-4672-90b9-988edb7a648f 61957-0320 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 020 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL 61957-0321_7e4a3aa9-0bef-46b9-a69a-cd10edd2481d 61957-0321 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 021 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL 61957-0322_60d1ec9a-f215-4e34-a062-fce3b591fe4e 61957-0322 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 022 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL 61957-0323_26c69eb6-ef08-4e60-bf74-b942ea3e735b 61957-0323 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 023 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL 61957-0330_278c20ce-b6c3-4f8b-8913-d5fa11e8ab71 61957-0330 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 030 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL 61957-0332_d997b4dd-7ea0-49d2-901d-35c5fb399887 61957-0332 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 032 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL 61957-0333_a70d80ce-d916-42dd-b5d0-576986d3d44a 61957-0333 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 033 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL 61957-0340_bd353d5c-07af-44cc-af20-8bdd78d9061d 61957-0340 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 040 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL 61957-0350_f58c9788-9871-4706-b179-a023f0ed953f 61957-0350 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 050 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL 61957-0401_277cf22c-ab6f-4a6c-a468-9a716bddd446 61957-0401 HUMAN OTC DRUG CD - Dior Multi-perfection Tinted Moisturizer Natural Radiance 1 - SPF 20 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100824 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.49; 4.74 mL/100mL; mL/100mL 61957-0402_6ef262c9-9b75-4c43-b278-b3aaf716736b 61957-0402 HUMAN OTC DRUG CD - Dior Multi-perfection Tinted Moisturizer Golden Radiance 2 - SPF 20 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100824 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.49; 4.74 mL/100mL; mL/100mL 61957-0403_75dd693c-985f-4aa1-89fa-0eabebd2bc09 61957-0403 HUMAN OTC DRUG CD - Dior Multi-perfection Tinted Moisturizer Bronze Radiance 3 - SPF 20 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100824 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.49; 4.74 mL/100mL; mL/100mL 61957-0510_16e88029-207c-42ec-8b8b-3100baf82b9a 61957-0510 HUMAN OTC DRUG CD DiorSkin Forever Compact Flawless Perfection Fusion Wear Makeup SPF 25 - 010 OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20110722 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g 61957-0511_f5564b61-5be3-44e5-ac57-bccaf84f6b19 61957-0511 HUMAN OTC DRUG CD DiorSkin Forever Compact Flawless Perfection Fusion Wear Makeup SPF 25 - 011 OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20110722 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g 61957-0520_9e5ddb10-40d2-4d5c-9cba-63ff8e2d1aea 61957-0520 HUMAN OTC DRUG CD DiorSkin Forever Compact Flawless Perfection Fusion Wear Makeup SPF 25 - 020 OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20110722 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g 61957-0521_96eafd9b-d5f4-409c-9a1c-b66201cec8c2 61957-0521 HUMAN OTC DRUG CD DiorSkin Forever Compact Flawless Perfection Fusion Wear Makeup SPF 25 - 021 OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20110722 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g 61957-0523_19a4bfa7-017b-478e-a60e-a10e04bc9adf 61957-0523 HUMAN OTC DRUG CD DiorSkin Forever Compact Flawless Perfection Fusion Wear Makeup SPF 25 - 023 OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20110722 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g 61957-0530_5ce2cd1c-61c6-4a72-9841-e2603b5811f4 61957-0530 HUMAN OTC DRUG CD DiorSkin Forever Compact Flawless Perfection Fusion Wear Makeup SPF 25 - 030 OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20110722 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g 61957-0532_11faf2f5-fefb-43cf-8c46-d6d9939490a6 61957-0532 HUMAN OTC DRUG CD DiorSkin Forever Compact Flawless Perfection Fusion Wear Makeup SPF 25 - 032 OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20110722 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g 61957-0540_2741d5e5-b976-40ac-b2e4-d81a379ff4da 61957-0540 HUMAN OTC DRUG CD DiorSkin Forever Compact Flawless Perfection Fusion Wear Makeup SPF 25 - 040 OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20110722 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g 61957-0550_04e5f2d7-cbe9-4315-8366-1b3e03ccc0c5 61957-0550 HUMAN OTC DRUG CD DiorSkin Forever Compact Flawless Perfection Fusion Wear Makeup SPF 25 - 050 OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20110722 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g 61957-0600_ad3e951d-d1fd-4346-92da-b4f3b4974eed 61957-0600 HUMAN OTC DRUG DIORSNOW White Reveal UVB Protection Sunscreen Pearly White SPF 50 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LIQUID TOPICAL 20120719 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.49; 3.55; 19 mL/100mL; mL/100mL; mL/100mL 61957-0601_73ba93f0-e8d2-4932-be90-9ffd5add4631 61957-0601 HUMAN OTC DRUG DIORSNOW White Reveal UVB Protection Sunscreen Translucent SPF 50 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LIQUID TOPICAL 20120719 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.49; 3.55; 19 mL/100mL; mL/100mL; mL/100mL 61957-0602_9da8d3f3-2648-4c97-b3da-80d3db2cc34d 61957-0602 HUMAN OTC DRUG CD DIORSNOW White Reveal Fresh Transparency Liquid Foundation with Sunscreen Broad Spectrum SPF 30 010 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 35; 42 mg/mL; mg/mL 61957-0603_1ec0d476-859d-4610-b076-1a34f3554e7d 61957-0603 HUMAN OTC DRUG CD DIORSNOW White Reveal Fresh Transparency Liquid Foundation with Sunscreen Broad Spectrum SPF 30 020 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 35; 42 mg/mL; mg/mL 61957-0604_1be8cd33-e9d6-4a8c-ac9f-5182a09e7b80 61957-0604 HUMAN OTC DRUG CD DIORSNOW White Reveal Fresh Transparency Liquid Foundation with Sunscreen Broad Spectrum SPF 30 021 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 35; 42 mg/mL; mg/mL 61957-0700_8501e462-70e3-4556-b26e-27f311645fc9 61957-0700 HUMAN OTC DRUG DIORSNOW BB Creme 010 White Reveal UV Protection Sunscreen Broad Spectrum SPF 50 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20120718 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.49; 2; 4.26 mL/100mL; mL/100mL; mL/100mL 61957-0701_57968857-b95a-44dd-a5d6-16afbdf95e8b 61957-0701 HUMAN OTC DRUG DIORSNOW BB Creme 020 White Reveal UV Protection Sunscreen Broad Spectrum SPF 50 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20120719 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.49; 2; 4.26 mL/100mL; mL/100mL; mL/100mL 61957-0800_acc65ee7-1550-4741-862f-fb415e116cef 61957-0800 HUMAN OTC DRUG CD DIOR PRESTIGE White Collection Satin Brightening Eye Cream Sunscreen SPF 15 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120722 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; 2.49 mL/100mL; mL/100mL 61957-0820_9e6df888-cc4c-4cbe-a607-4d55c3adec26 61957-0820 HUMAN OTC DRUG CD CAPTURE TOTALE MULTI-PERFECTION MAKEUP BASE SUNSCREEN BROAD SPECTRUM SPF 25 OCTINOXATE CREAM TOPICAL 20140609 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 74.9; 38.4 mg/mL; mg/mL 61957-0900_9d21cdbe-2329-4bf0-a71b-b20b87b19efa 61957-0900 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 010 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 61957-0901_1f2e83ba-8cb4-4143-b258-67855e7e5d3b 61957-0901 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 020 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 61957-0902_d3775bd8-54c5-43e0-9d9d-f586a1ae3a75 61957-0902 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 021 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 61957-0903_1f096e78-af0a-4a2a-9692-8561632a66ec 61957-0903 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 022 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 61957-0904_68ec4b75-be3f-44bc-9c75-29eeb70806cd 61957-0904 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 023 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 61957-0905_afa657c9-f379-449c-934d-b4718a8ad866 61957-0905 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 030 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 61957-0906_8bacea27-59c6-4798-90e2-a3589e6d450d 61957-0906 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 031 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 61957-0907_77c9ab11-da26-422d-a562-6369817ad4b7 61957-0907 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 032 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 61957-0908_1edc9d91-18c4-4668-8b3f-e9f3452f6ef9 61957-0908 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 040 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 61957-0909_deff735c-18b2-49a9-9342-aac44a6bd486 61957-0909 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 050 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL 61957-1000_487897a4-ea39-4cff-9809-3ca2c092f91d 61957-1000 HUMAN OTC DRUG DiorSkin Nude 050 Cafe Moka OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20100610 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 6; 2.97 g/100g; g/100g 61957-1001_8f37b8f9-4656-42df-8913-995657d60a20 61957-1001 HUMAN OTC DRUG DiorSkin Nude 020 Beige Praline OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20100610 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 6; 2.97 g/100g; g/100g 61957-1002_e68be1ff-edd5-4460-a8fb-ead190702acd 61957-1002 HUMAN OTC DRUG DiorSkin Nude 032 Sable Rose OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20100610 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 6; 2.97 g/100g; g/100g 61957-1003_81a0bb3e-376d-4016-a91a-cb3da250506d 61957-1003 HUMAN OTC DRUG DiorSkin Nude 033 The Passion OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20100610 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 6; 2.97 g/100g; g/100g 61957-1004_ee2af5de-5db9-45b2-bf53-92c5150e07d7 61957-1004 HUMAN OTC DRUG DiorSkin Nude 040 Golden Caramel OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20100610 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 6; 2.97 g/100g; g/100g 61957-1005_e0b83bd5-51a1-4352-80db-70e8c524408e 61957-1005 HUMAN OTC DRUG DiorSkin Nude 050 Cafe Moka OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20100610 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 6; 2.97 g/100g; g/100g 61957-1015_4c004032-785e-483e-aea4-634635114627 61957-1015 HUMAN OTC DRUG DiorSkin Nude 010 Ivory TITANIUM DIOXIDE, OCTINOXATE EMULSION TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1016_5c6f3f54-589c-4d6f-a359-4e937cbfdc56 61957-1016 HUMAN OTC DRUG DiorSkin Nude 012 Porcelain TITANIUM DIOXIDE, OCTINOXATE EMULSION TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1017_97e5de21-78e2-434f-ad2d-dc8cfbeadf41 61957-1017 HUMAN OTC DRUG DiorSkin Nude 020 Light Beige TITANIUM DIOXIDE, OCTINOXATE EMULSION TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1018_174e5096-78a2-4e6c-a3b9-a9221c451050 61957-1018 HUMAN OTC DRUG DiorSkin Nude 021 Linen TITANIUM DIOXIDE, OCTINOXATE EMULSION TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1019_d23e38ad-b62a-4160-b14e-75d66597d327 61957-1019 HUMAN OTC DRUG DiorSkin Nude 022 Cameo TITANIUM DIOXIDE, OCTINOXATE EMULSION TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1020_49229fb3-bd42-4a49-a9a1-b36b2857334a 61957-1020 HUMAN OTC DRUG DiorSkin Nude 023 Peach TITANIUM DIOXIDE, OCTINOXATE EMULSION TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1021_a1635e16-8b2c-4986-93f7-3fc40342e2ed 61957-1021 HUMAN OTC DRUG DiorSkin Nude 030 Medium Beige TITANIUM DIOXIDE, OCTINOXATE EMULSION TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1022_ff08f8a1-25aa-44d3-ba9b-fc222b5eacba 61957-1022 HUMAN OTC DRUG DiorSkin Nude 031 Sand TITANIUM DIOXIDE, OCTINOXATE EMULSION TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1023_9041950b-64c8-4fea-86c7-ea8a758fa1fa 61957-1023 HUMAN OTC DRUG DiorSkin Nude 032 Rosy Beige TITANIUM DIOXIDE, OCTINOXATE EMULSION TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1024_fedd5897-1060-455b-8ea8-f19e3ab0ed3d 61957-1024 HUMAN OTC DRUG DiorSkin Nude 040 Honey Beige TITANIUM DIOXIDE, OCTINOXATE EMULSION TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1025_4c1d99fb-ca77-4ba4-b7a5-bb55ab2e3e4d 61957-1025 HUMAN OTC DRUG DiorSkin Nude 050 Dark Beige TITANIUM DIOXIDE, OCTINOXATE EMULSION TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1026_1947ec03-4c05-4a24-9cfe-993fffc21548 61957-1026 HUMAN OTC DRUG DiorSkin Nude 051 Dark Sand TITANIUM DIOXIDE, OCTINOXATE EMULSION TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1027_d6acbedd-51f6-43ee-93b2-e741f65c98d0 61957-1027 HUMAN OTC DRUG DiorSkin Nude 070 Dark Brown TITANIUM DIOXIDE, OCTINOXATE EMULSION TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1030_42ae4c35-bcc2-4cc9-8514-244dfdcec30e 61957-1030 HUMAN OTC DRUG HYDRA LIFE BASE DE TEINT SERUM OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100608 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 7.49; 3.16 mL/100mL; mL/100mL 61957-1042_1a8f2ca2-c989-4667-b22f-fb6199cb7682 61957-1042 HUMAN OTC DRUG Rouge Dior 510 Nude Serum OCTINOXATE PASTE TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1043_ae27e055-66d7-4805-ad4e-f9386955d0ff 61957-1043 HUMAN OTC DRUG Rouge Dior 640 Soft Pink Serum OCTINOXATE PASTE TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1044_62f92eb3-d588-4bbc-982c-34754af958bc 61957-1044 HUMAN OTC DRUG Rouge Dior 710 Beige Serum OCTINOXATE PASTE TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1045_2840446e-82c8-4ed2-a995-7978c52eb256 61957-1045 HUMAN OTC DRUG Rouge Dior 730 Coral Serum OCTINOXATE PASTE TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1046_8216613d-ad8c-49a3-8660-18816b428e58 61957-1046 HUMAN OTC DRUG Rouge Dior 740 Rosewood Serum OCTINOXATE PASTE TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1047_266c056a-2d6c-466b-8596-b5c332aa1dba 61957-1047 HUMAN OTC DRUG Rouge Dior 760 Raspberry Serum OCTINOXATE PASTE TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1048_eea2b542-f318-47cf-afe0-75592f60ff5c 61957-1048 HUMAN OTC DRUG Rouge Dior 840 Crimson Serum OCTINOXATE PASTE TOPICAL 20100604 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1049_8541a637-ed17-471e-af5c-41307cca8c7e 61957-1049 HUMAN OTC DRUG Rouge Dior 910 Mocha Serum OCTINOXATE PASTE TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1050_3cad0b20-15b6-4fdc-b504-be50f1631e18 61957-1050 HUMAN OTC DRUG Rouge Dior Serum de Rouge Luminous Color Lip Treatment 650 OCTINOXATE LIPSTICK TOPICAL 20100507 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1051_f77fe449-996e-450e-9665-8775b6dff84e 61957-1051 HUMAN OTC DRUG Rouge Dior Serum de Rouge Luminous Color Lip Treatment 660 OCTINOXATE LIPSTICK TOPICAL 20100507 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1052_c9c5ad17-6a81-4b56-84a6-089f916dae81 61957-1052 HUMAN OTC DRUG Rouge Dior Serum de Rouge Luminous Color Lip Treatment 850 OCTINOXATE LIPSTICK TOPICAL 20100507 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1053_aae25c82-2c25-4ba2-b9ee-3f5719c44f2b 61957-1053 HUMAN OTC DRUG Rouge Dior 860 Violet Serum OCTINOXATE PASTE TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1059_8079a34c-85fb-4035-82f4-fe5bc869f05e 61957-1059 HUMAN OTC DRUG Rouge Dior 850 Red Serum OCTINOXATE PASTE TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1068_1a47c2c6-b338-47c0-bef9-dd6b35145c03 61957-1068 HUMAN OTC DRUG Rouge Dior 470 Pearly Pink Serum OCTINOXATE PASTE TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1069_e608a598-9cb4-42ed-b153-80564daa26cc 61957-1069 HUMAN OTC DRUG Rouge Dior 560 Radiant Pink Serum OCTINOXATE PASTE TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1070_6cad955a-da79-4fa2-a229-1595760ee8e6 61957-1070 HUMAN OTC DRUG Rouge Dior 670 Pink Ruby Serum OCTINOXATE PASTE TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1071_cc2a5bd6-ab1d-4727-9b39-0ccf3bb15ef2 61957-1071 HUMAN OTC DRUG Rouge Dior 870 Ruby Serum OCTINOXATE PASTE TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1072_d66fbbcf-312b-406f-94b9-e28d3ad0178b 61957-1072 HUMAN OTC DRUG Rouge Dior 880 Plum Serum OCTINOXATE PASTE TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1080_fc27b6b5-e869-4799-a358-69cc2c1ea598 61957-1080 HUMAN OTC DRUG Dior Addict Lip Glow OCTINOXATE PASTE TOPICAL 20100610 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1081_cabbf2e5-5aac-4ebe-aedf-906018ae3787 61957-1081 HUMAN OTC DRUG Rouge Dior 660 Garnet Serum OCTINOXATE PASTE TOPICAL 20100625 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1089_9ca66ca4-0775-49e7-bdfb-6d8cc6ec5e54 61957-1089 HUMAN OTC DRUG Rouge Dior 650 Peach Serum OCTINOXATE PASTE TOPICAL 20100625 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 7.5 g/100g 61957-1090_f549d47e-0676-4238-8705-2eaf27d067d3 61957-1090 HUMAN OTC DRUG CD Creme De Rose Plumping Lip Balm OCTINOXATE, AVOBENZONE PASTE TOPICAL 20100611 OTC MONOGRAPH FINAL part352 Parfums Christian Dior AVOBENZONE; OCTINOXATE 1; 7.5 g/100g; g/100g 61957-1101_55954ffb-1ee8-4079-a6ed-ab9c9fe3bd39 61957-1101 HUMAN OTC DRUG HYDRA LIFE PRO-YOUTH SKIN TINT 1 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100525 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.49; 4.74 mL/100mL; mL/100mL 61957-1102_17d2756c-7c08-4237-87db-22769b31aadc 61957-1102 HUMAN OTC DRUG HYDRA LIFE PRO-YOUTH SKIN TINT 2 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100525 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.49; 4.74 mL/100mL; mL/100mL 61957-1103_6c878372-b7cd-4ae1-b54c-2bea130e676c 61957-1103 HUMAN OTC DRUG HYDRA LIFE PRO-YOUTH SKIN TINT 3 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100525 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.49; 4.74 mL/100mL; mL/100mL 61957-1110_8a0288c6-0bca-42c5-86d9-b42cbf306e85 61957-1110 HUMAN OTC DRUG HYDRALIFE YOUTH ESSENTIAL HYDRATING ESSENCE-IN-BASE SPF 30 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, OCTOCRYLENE CREAM TOPICAL 20111015 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 7.49; 2; 3; 2.49 mL/100mL; mL/100mL; mL/100mL; mL/100mL 61957-1111_9739b339-3e17-45e1-b68a-6353511f1d16 61957-1111 HUMAN OTC DRUG HYDRALIFE BB CREME Enhancing Moisturizer For Immediate Beauty SPF 30 OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20111015 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 3.75; 1; 3.55 mL/100mL; mL/100mL; mL/100mL 61957-1112_8caded6c-324f-4fdb-9d26-91982bfb7d92 61957-1112 HUMAN OTC DRUG CD HydraLife BB Creme Enhancing Sunscreen Moisturizer For Immediate Beauty Golden Peach Broad Spectrum SPF 30 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20130103 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 37.5; 10; 35.5 mg/mL; mg/mL; mg/mL 61957-1113_2b3d2f01-0dd5-4950-9532-0b6984ea5831 61957-1113 HUMAN OTC DRUG CD HydraLife BB Creme Enhancing Sunscreen Moisturizer For Immediate Beauty Luminous Beige Broad Spectrum SPF 30 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20130103 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 37.5; 10; 35.5 mg/mL; mg/mL; mg/mL 61957-1114_e5fff8b7-532b-438f-8862-62b39944fac7 61957-1114 HUMAN OTC DRUG CD HydraLife BB Creme Enhancing Sunscreen Moisturizer For Immediate Beauty Sunny Amber Broad Spectrum SPF 30 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20130103 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 37.5; 10; 35.5 mg/mL; mg/mL; mg/mL 61957-1120_c212273c-0e06-41aa-8d18-a296567a0a0c 61957-1120 HUMAN OTC DRUG CD HydraLife BB Eye Creme Enhancing Sunscreen Eye Illuminator Luminous Beige Broad Spectrum SPF 20 TITANIUM DIOXIDE CREAM TOPICAL 20130103 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 36.5 mg/mL 61957-1121_7683b62d-9d32-4e85-904d-0be8fc2b75bb 61957-1121 HUMAN OTC DRUG CD HydraLife BB Eye Creme Enhancing Sunscreen Eye Illuminator Luminous Peach Broad Spectrum SPF 20 TITANIUM DIOXIDE CREAM TOPICAL 20130103 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 36.5 mg/mL 61957-1201_b4dcac57-efdc-4c29-9611-d0f2d386ede3 61957-1201 HUMAN OTC DRUG DiorSkin Forever Wear Extending Invisible Retouch SPF 8 - 001 OCTINOXATE POWDER TOPICAL 20101210 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 5 g/100g 61957-1202_ee6d6f62-3948-425b-a286-5c6aa2e2f924 61957-1202 HUMAN OTC DRUG DiorSkin Forever Wear Extending Invisible Retouch SPF 8 - 002 OCTINOXATE POWDER TOPICAL 20101210 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 5 g/100g 61957-1203_4af651fc-4d16-4fcb-9932-9b88d820ee28 61957-1203 HUMAN OTC DRUG DiorSkin Forever Wear Extending Invisible Retouch SPF 8 - 003 OCTINOXATE POWDER TOPICAL 20101210 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 5 g/100g 61957-1310_69293272-5148-4039-b144-ecd6ec705ef4 61957-1310 HUMAN OTC DRUG DiorSnow White Reveal Instant Spot Concealer SPF 50 Ivory 010 OCTINOXATE EMULSION TOPICAL 20110113 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE 7.49; 2.5 mL/100mL; mL/100mL 61957-1320_d6113249-2cf6-4de2-b848-3b2bf1165230 61957-1320 HUMAN OTC DRUG DiorSnow White Reveal Instant Spot Concealer SPF 50 Light Beige 020 OCTINOXATE EMULSION TOPICAL 20110113 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE 7.49; 2.5 mL/100mL; mL/100mL 61957-1410_fa9a8e6b-bd35-47e6-8eb9-d781f3a147a2 61957-1410 HUMAN OTC DRUG Capture Totale Radiance Restoring Serum Foundation SPF 15 010 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101216 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1412_03938686-8162-4bad-91c1-2d0690e19a90 61957-1412 HUMAN OTC DRUG Capture Totale Radiance Restoring Serum Foundation SPF 15 012 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101216 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1420_9a132f01-63d7-4b49-9e47-f96baee8f6e3 61957-1420 HUMAN OTC DRUG Capture Totale Radiance Restoring Serum Foundation SPF 15 020 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101216 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1421_704372c9-8dc0-4745-ace5-43b9086e946c 61957-1421 HUMAN OTC DRUG Capture Totale Radiance Restoring Serum Foundation SPF 15 021 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101216 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1423_f42ab6f9-ebfb-45fb-83ef-44a876b24c9a 61957-1423 HUMAN OTC DRUG Capture Totale Radiance Restoring Serum Foundation SPF 15 023 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101216 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1430_122e617d-3c1e-47ee-95f2-5c0ff1a57b1a 61957-1430 HUMAN OTC DRUG Capture Totale Radiance Restoring Serum Foundation SPF 15 030 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101216 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1433_806ad61d-46db-45a6-9ada-e9291e3b178c 61957-1433 HUMAN OTC DRUG Capture Totale Radiance Restoring Serum Foundation SPF 15 033 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101216 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1440_505aa2fc-afde-4764-b80a-3cdcb842624e 61957-1440 HUMAN OTC DRUG Capture Totale Radiance Restoring Serum Foundation SPF 15 040 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101216 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1450_724e51fd-bba2-4fea-96d7-6f491d7576d1 61957-1450 HUMAN OTC DRUG Capture Totale Radiance Restoring Serum Foundation SPF 15 050 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101216 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL 61957-1460_b9a8c6f9-b161-4d6d-843e-e8876d5ef781 61957-1460 HUMAN OTC DRUG CAPTURE TOTALE MULTI-PERFECTION CREME SPF 20 OCTINOXATE, OXYBENZONE, OCTOCRYLENE, TITANIUM DIOXIDE CREAM TOPICAL 20111014 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 7.49; 2; 3; 1.78 mL/100mL; mL/100mL; mL/100mL; mL/100mL 61957-1461_81052b4b-a72f-4029-9d96-3160619fefa6 61957-1461 HUMAN OTC DRUG CD CAPTURE TOTALE Multi-Perfection UVB Base Sunscreen SPF 50 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20130211 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 74.9; 20; 88.8 mg/mL; mg/mL; mg/mL 61957-1470_af0be53e-5823-444a-b696-0cb8e37dda0f 61957-1470 HUMAN OTC DRUG CAPTURE TOTALE COMPACT RADIANCE RESTORING LINE SMOOTHING MAKEUP SPF 20 010 Ivory OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20111219 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g 61957-1471_8a286243-dba1-41cb-aa8b-58b8066e0bbd 61957-1471 HUMAN OTC DRUG CAPTURE TOTALE COMPACT RADIANCE RESTORING LINE SMOOTHING MAKEUP SPF 20 020 Light Beige OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20111219 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g 61957-1472_861c23e4-7c71-413b-9ecc-898cc1e86f24 61957-1472 HUMAN OTC DRUG CAPTURE TOTALE COMPACT RADIANCE RESTORING LINE SMOOTHING MAKEUP SPF 20 021 Linen OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20111219 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g 61957-1473_00b286fc-9aea-42e2-b2f5-6295ba9e8b4b 61957-1473 HUMAN OTC DRUG CAPTURE TOTALE COMPACT RADIANCE RESTORING LINE SMOOTHING MAKEUP SPF 20 023 Peach OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20111219 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g 61957-1500_4cc9e673-c9b9-426c-a9d1-8d80edf9c478 61957-1500 HUMAN OTC DRUG CD DiorSnow UV Shield Pearly White - SPF50 ZINC OXIDE, OCTINOXATE LIQUID TOPICAL 20100824 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; ZINC OXIDE 7.5; 19 mL/100mL; mL/100mL 61957-1501_7eea2759-2e6f-4e66-a9a4-ca44a789ad44 61957-1501 HUMAN OTC DRUG CD DiorSnow UV Shield Transluscent - SPF50 ZINC OXIDE, OCTINOXATE LIQUID TOPICAL 20100824 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; ZINC OXIDE 7.5; 19 mL/100mL; mL/100mL 61957-1510_4b44af59-4fe1-45ff-af97-fb23f0b97f35 61957-1510 HUMAN OTC DRUG CD Dior Prestige White Collection Satin Brightening UV Base SPF 50 TITANIUM DIOXIDE, OCTINOXATE, OXYBENZONE LIQUID TOPICAL 20110329 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.49; 2; 8.88 mL/100mL; mL/100mL; mL/100mL 61957-1520_76ca940c-d534-4bc5-8b7d-35fd2edf3384 61957-1520 HUMAN OTC DRUG CD DIORSNOW UV SHIELD Brightening Illuminating UV Protection With Sunscreen TRANSLUCENT BROAD SPECTRUM SPF 50 ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20140807 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 74.9; 20; 21.3; 187 mg/mL; mg/mL; mg/mL; mg/mL 61957-1601_b7d960ff-feda-486c-8db5-98e1d36d94a5 61957-1601 HUMAN OTC DRUG DiorSnow White Reveal UV Shield Loose Powder Snowy White 001 OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20100903 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5; 3.56 g/100g; g/100g 61957-1602_9d9ce581-df19-4d79-8a35-8604c7126c54 61957-1602 HUMAN OTC DRUG DiorSnow White Reveal UV Shield Loose Powder Healthy Pink 002 OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20100903 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5; 3.56 g/100g; g/100g 61957-1603_53503d89-404b-420b-8437-0a24365b877b 61957-1603 HUMAN OTC DRUG DiorSnow White Reveal UV Shield Loose Powder Tender Peach 003 OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20100903 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5; 3.56 g/100g; g/100g 61957-1710_aa5e1388-152c-4df8-b39e-ab2bc1448862 61957-1710 HUMAN OTC DRUG Dior Snow Light Veil 010 Ivory SPF 20 OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE POWDER TOPICAL 20101210 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5.99; 2; 2.43 g/100g; g/100g; g/100g 61957-1712_a440c9d7-cf17-4dc1-b44f-5aa18bb9be36 61957-1712 HUMAN OTC DRUG Dior Snow Light Veil 012 Porcelain SPF 20 OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE POWDER TOPICAL 20101210 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5.99; 2; 2.43 g/100g; g/100g; g/100g 61957-1720_7b6b9156-a725-46ac-9945-4fcac1b096f9 61957-1720 HUMAN OTC DRUG DiorSnow Light Veil 020 Light Beige SPF 20 OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE POWDER TOPICAL 20101210 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5.99; 2; 2.43 g/100g; g/100g; g/100g 61957-1721_a70ab8b0-ffdd-49e7-bcaa-8065089fbb03 61957-1721 HUMAN OTC DRUG DiorSnow Light Veil 021 Linen SPF 20 OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE POWDER TOPICAL 20101210 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5.99; 2; 2.43 g/100g; g/100g; g/100g 61957-1810_fb3003cf-b733-413a-ac0b-cd153fac64ce 61957-1810 HUMAN OTC DRUG CD DiorSnow White Reveal UV Shield Foundation 010-Ivory OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20100626 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 6; 5.8 mL/100mL; mL/100mL 61957-1812_ed1925ad-4ddf-41ac-abcd-353917279d90 61957-1812 HUMAN OTC DRUG CD DiorSnow White Reveal UV Shield Foundation 012-Porcelain OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20100626 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 6; 5.8 mL/100mL; mL/100mL 61957-1820_ff146a7c-bced-45ae-b086-95fae88c7162 61957-1820 HUMAN OTC DRUG CD DiorSnow White Reveal UV Shield Foundation 020-Light Beige OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20100626 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 6; 5.8 mL/100mL; mL/100mL 61957-1821_a289c8d7-c959-4de5-a1cd-1317f54ac575 61957-1821 HUMAN OTC DRUG CD DiorSnow White Reveal UV Shield Foundation 021-Linen OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20100626 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 6; 5.8 mL/100mL; mL/100mL 61957-1822_2162b13d-0ec9-4f7f-b941-de7a6e0016a6 61957-1822 HUMAN OTC DRUG CD DiorSnow White Reveal UV Shield Foundation 022-Cameo OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20100626 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 6; 5.8 mL/100mL; mL/100mL 61957-1830_f66cc024-e9cd-4557-bbe9-842ebe712113 61957-1830 HUMAN OTC DRUG CD DiorSnow White Reveal UV Shield Foundation 030-Medium Beige OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20100626 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 6; 5.8 mL/100mL; mL/100mL 61957-1840_eda45741-ac76-484f-b327-fd46369ea6f4 61957-1840 HUMAN OTC DRUG DIORSNOW WHITE REVEAL PURE TRANSPARENCY MAKEUP SPF 30 010 Ivory TITANIUM DIOXIDE, OCTINOXATE, OXYBENZONE POWDER TOPICAL 20111216 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5.99; 2; 12.45 g/100g; g/100g; g/100g 61957-1841_5947d24b-718a-4301-9be5-3d7fa48801c2 61957-1841 HUMAN OTC DRUG DIORSNOW WHITE REVEAL PURE TRANSPARENCY MAKEUP SPF 30 012 Porcelain TITANIUM DIOXIDE, OCTINOXATE, OXYBENZONE POWDER TOPICAL 20111217 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5.99; 2; 12.45 g/100g; g/100g; g/100g 61957-1842_b79511fd-08af-4da1-b045-360aac800f42 61957-1842 HUMAN OTC DRUG DIORSNOW WHITE REVEAL PURE TRANSPARENCY MAKEUP SPF 30 020 Light Beige TITANIUM DIOXIDE, OCTINOXATE, OXYBENZONE POWDER TOPICAL 20111217 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5.99; 2; 12.45 g/100g; g/100g; g/100g 61957-1843_18daa5f6-1461-4784-9843-3e20c9f56b55 61957-1843 HUMAN OTC DRUG DIORSNOW WHITE REVEAL PURE TRANSPARENCY MAKEUP SPF 30 021 Linen TITANIUM DIOXIDE, OCTINOXATE, OXYBENZONE POWDER TOPICAL 20111217 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5.99; 2; 12.45 g/100g; g/100g; g/100g 61957-1844_0801a6fd-11f4-4ce0-882a-789421674b82 61957-1844 HUMAN OTC DRUG DIORSNOW WHITE REVEAL PURE TRANSPARENCY MAKEUP SPF 30 030 Medium Beige TITANIUM DIOXIDE, OCTINOXATE, OXYBENZONE POWDER TOPICAL 20111217 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5.99; 2; 12.45 g/100g; g/100g; g/100g 61957-1900_7954f300-b3e6-44ff-962c-f4327d771b77 61957-1900 HUMAN OTC DRUG DIORSNOW UV Shield White Reveal Moisturizing UV Protection Transluscent SPF 50 ZINC OXIDE, OCTINOXATE CREAM TOPICAL 20101130 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; ZINC OXIDE 7.5; 19 mL/100mL; mL/100mL 61957-1901_f5cada23-df95-42a9-bb66-987d203e4706 61957-1901 HUMAN OTC DRUG DIORSNOW UV Shield White Reveal Moisturizing UV Protection Pearly White SPF 50 ZINC OXIDE, OCTINOXATE CREAM TOPICAL 20101130 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; ZINC OXIDE 7.5; 19 mL/100mL; mL/100mL 61957-1910_e44eae9b-bb2f-407b-8a52-ac5c6085a723 61957-1910 HUMAN OTC DRUG DIORSNOW UV Shield White Reveal UV Protection BB Creme Pearly White SPF 50 OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20101130 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.49; 2; 4.26 mL/100mL; mL/100mL; mL/100mL 61957-1920_1eb7351b-e956-49fa-a957-4118755efaf8 61957-1920 HUMAN OTC DRUG DIORSNOW UV SHIELD BB CREME WHITE REVEAL UV PROTECTION SPF 50 OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20111014 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.49; 2; 4.26 mL/100mL; mL/100mL; mL/100mL 61957-1921_52eeb96d-8433-4ae0-87a8-935fc143d2b4 61957-1921 HUMAN OTC DRUG CD DIORSNOW UV SHIELD BB CREME LIGHT SHADE WHITE REVEAL UV PROTECTION SPF 50 OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE LOTION TOPICAL 20111111 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.49; 2; 4.26 mL/100mL; mL/100mL; mL/100mL 61957-1930_fef77bb5-837c-43cb-bf0a-d97eceaba100 61957-1930 HUMAN OTC DRUG DIORSNOW WHITE REVEAL PERFECTING MAKEUP UV BASE SPF 35 BEIGE CRISTAL OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20111015 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.49; 3; 4.44 mL/100mL; mL/100mL; mL/100mL 61957-1931_0ce62389-029e-48fc-9f5c-db078c9dc49c 61957-1931 HUMAN OTC DRUG DIORSNOW WHITE REVEAL PERFECTING MAKEUP UV BASE SPF 35 BLEU CRISTAL OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20111015 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.49; 3; 4.44 mL/100mL; mL/100mL; mL/100mL 61957-1932_070929a7-8e5d-487d-aee8-93a55e5f065d 61957-1932 HUMAN OTC DRUG DIORSNOW WHITE REVEAL PERFECTING MAKEUP UV BASE SPF 35 ROSE CRISTAL OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20111015 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.49; 3; 3.55 mL/100mL; mL/100mL; mL/100mL 61957-2010_6a4223b0-108a-4ff9-95ed-199eb849f22d 61957-2010 HUMAN OTC DRUG Diorskin Nude Natural Glow Makeup 010 Ivory OCTINOXATE, OXYBENZONE PASTE TOPICAL 20100804 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE 3.75; 1 g/100g; g/100g 61957-2020_e0a5f752-7713-45c5-a820-a23ae7cb28af 61957-2020 HUMAN OTC DRUG Diorskin Nude Natural Glow Makeup 020 Light Beige OCTINOXATE, OXYBENZONE PASTE TOPICAL 20100804 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE 3.75; 1 g/100g; g/100g 61957-2022_a21124dd-da5a-468d-b2cd-55e60b85a69d 61957-2022 HUMAN OTC DRUG Diorskin Nude Natural Glow Makeup 022 Cameo OCTINOXATE, OXYBENZONE PASTE TOPICAL 20100804 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE 3.75; 1 g/100g; g/100g 61957-2030_d65d2c9f-405b-400b-a748-e212c059faa7 61957-2030 HUMAN OTC DRUG Diorskin Nude Natural Glow Makeup 030 Medium Beige OCTINOXATE, OXYBENZONE PASTE TOPICAL 20100804 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE 3.75; 1 g/100g; g/100g 61957-2040_c799cbf3-bc03-402c-a74d-5d01ba34763b 61957-2040 HUMAN OTC DRUG Diorskin Nude Natural Glow Makeup 040 Honey Beige OCTINOXATE, OXYBENZONE PASTE TOPICAL 20100804 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE 3.75; 1 g/100g; g/100g 61957-2050_2434ec82-98f2-47b3-879a-592bb37d8871 61957-2050 HUMAN OTC DRUG Diorskin Nude Natural Glow Makeup 050 Dark Beige OCTINOXATE, OXYBENZONE PASTE TOPICAL 20100804 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE 3.75; 1 g/100g; g/100g 61957-2070_d97ad3bd-3d75-49ec-b7da-76d83c8d8bed 61957-2070 HUMAN OTC DRUG Diorskin Nude Natural Glow Makeup 070 Dark Brown OCTINOXATE, OXYBENZONE PASTE TOPICAL 20100804 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE 3.75; 1 g/100g; g/100g 61957-2100_f73384d2-c2ae-414c-913f-361a1b7ad14d 61957-2100 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 010 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL 61957-2101_c2429497-adc7-4ac8-940b-533b9356c90a 61957-2101 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 020 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL 61957-2102_6506fbee-935c-4e37-8bfd-8f4a796105b7 61957-2102 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 021 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL 61957-2103_3e5f0a8b-f579-4c60-97de-d1eea0b98a9a 61957-2103 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 022 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL 61957-2104_212d0424-ec81-4e6d-a119-10e955f69a8f 61957-2104 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 023 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL 61957-2105_6378ef1c-1a74-44a9-b0f8-c9f594455fc1 61957-2105 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 030 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL 61957-2106_598ae52d-d6b3-45ae-a662-588fe760c5ca 61957-2106 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 031 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL 61957-2107_9c652c45-0957-4571-9b8a-351ed791efae 61957-2107 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 032 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL 61957-2108_667e7e23-acbc-47f6-8cbd-692cd11c3db5 61957-2108 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 033 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL 61957-2109_7e75887f-60bf-4525-a333-a07a262b6fd4 61957-2109 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 040 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL 61957-2110_031840c5-93ef-4f2b-bb7d-71bb53068c8e 61957-2110 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 050 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL 61957-2111_6b41d524-20cc-4940-91a0-001125a174bd 61957-2111 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 060 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL 61957-2112_f4bf0efb-90c5-494e-bccb-c908109898c3 61957-2112 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 070 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL 61957-2113_4990551e-7fac-4354-a733-ee4f5980fa99 61957-2113 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 080 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL 61957-2120_413336f2-c740-44e7-bbe3-a4ea875bd5f6 61957-2120 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 OCTINOXATE LOTION TOPICAL 20141012 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL 61957-2121_6d45c917-cfa8-49b3-a18b-4e8f0b54184c 61957-2121 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 OCTINOXATE LOTION TOPICAL 20141012 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL 61957-2122_79a936c3-fc69-43a8-823e-d1568489e4b8 61957-2122 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 OCTINOXATE LOTION TOPICAL 20141012 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL 61957-2123_a5f490bc-2810-40f2-997a-e000f1184a43 61957-2123 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 OCTINOXATE LOTION TOPICAL 20141012 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL 61957-2124_ae789ac5-086e-4b6d-bfc2-febdb30c133c 61957-2124 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 OCTINOXATE LOTION TOPICAL 20141012 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL 61957-2125_fffc1aef-1955-48e1-9b66-a39b5ff91de1 61957-2125 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 OCTINOXATE LOTION TOPICAL 20141012 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL 61957-2126_f4f9390d-2268-47ca-8a7b-617d7c549e9c 61957-2126 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 OCTINOXATE LOTION TOPICAL 20141012 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL 61957-2127_25560928-5ed8-4d2a-8d5e-f552456a2033 61957-2127 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 OCTINOXATE LOTION TOPICAL 20141012 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL 61957-2128_7d2ab485-4c0e-476c-9110-81f6a00343ce 61957-2128 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 OCTINOXATE LOTION TOPICAL 20141012 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL 61957-2130_ff589562-669f-4745-a54c-c00154754595 61957-2130 HUMAN OTC DRUG DIORSKIN NUDE BB CREME NUDE GLOW SKIN-PERFECTING BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF10 025 TITANIUM DIOXIDE CREAM TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 1 mg/mL 61957-2131_d3e68154-6e40-4744-be27-244d87261ea6 61957-2131 HUMAN OTC DRUG CD DIORSKIN NUDE CREME Nude Glow Creme Gel Compact Makeup Sunscreen Broad Spectrum SPF20 010 OCTINOXATE, OXYBENZONE CREAM TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE 37.5; 10 mg/g; mg/g 61957-2132_ccdb1ea8-dd6f-4d67-8504-aed439d7b5bd 61957-2132 HUMAN OTC DRUG CD DIORSKIN NUDE CREME Nude Glow Creme Gel Compact Makeup Sunscreen Broad Spectrum SPF20 020 OCTINOXATE, OXYBENZONE CREAM TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE 37.5; 10 mg/g; mg/g 61957-2133_bbbd6abe-88d7-4e18-bba9-b9b4b17ee6f5 61957-2133 HUMAN OTC DRUG CD DIORSKIN NUDE CREME Nude Glow Creme Gel Compact Makeup Sunscreen Broad Spectrum SPF20 030 OCTINOXATE, OXYBENZONE CREAM TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE 37.5; 10 mg/g; mg/g 61957-2134_3386e7b1-49c5-423f-b5fe-dd6b781f01f6 61957-2134 HUMAN OTC DRUG CD DIORSKIN NUDE CREME Nude Glow Creme Gel Compact Makeup Sunscreen Broad Spectrum SPF20 040 OCTINOXATE, OXYBENZONE CREAM TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE 37.5; 10 mg/g; mg/g 61957-2135_21666dad-5234-4ef2-b218-1bf60e944ccc 61957-2135 HUMAN OTC DRUG CD DIORSKIN NUDE CREME Nude Glow Creme Gel Compact Makeup Sunscreen Broad Spectrum SPF20 050 OCTINOXATE, OXYBENZONE CREAM TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE 37.5; 10 mg/g; mg/g 61957-2150_a63a0a39-894c-49f7-a793-2e583db77520 61957-2150 HUMAN OTC DRUG CD DIORSKIN CITY DEFENSE Toxin Shield Pollution UV Advanced Protection with sunscreen Broad Spectrum SPF50 OCTINOXATE, OXYBENZONE, ZINC OXIDE LIQUID TOPICAL 20140924 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; ZINC OXIDE 4.49; 2; 20.9 mg/mL; mg/mL; mg/mL 61957-2503_86f25407-f8ec-4da6-94e5-6357b6fe71ad 61957-2503 HUMAN OTC DRUG CD Hydra Life Pro-Youth Protective Fluid OCTINOXATE, AVOBENZONE, OCTOCRYLENE, SULISOBENZONE LIQUID TOPICAL 20100507 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior AVOBENZONE; OCTINOXATE; OCTOCRYLENE; SULISOBENZONE 3; 7.49; 2; 1.5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 61957-2553_fabf1c91-6eed-479a-96e5-4112075ad46e 61957-2553 HUMAN OTC DRUG CD Hydra Life Pro-Youth Protective SPF 15 OCTINOXATE, AVOBENZONE, OCTOCRYLENE, SULISOBENZONE CREAM TOPICAL 20100507 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior AVOBENZONE; OCTINOXATE; OCTOCRYLENE; SULISOBENZONE 3; 7.49; 2; 1 mL/100mL; mL/100mL; mL/100mL; mL/100mL 61957-9400_aaadbc28-453c-4e97-bd47-8f8a27b1cb38 61957-9400 HUMAN OTC DRUG Christian Dior Prestige Brightening Revitalizing UV Base SPF 50 TITANIUM DIOXIDE, OCTINOXATE, OXYBENZONE LIQUID TOPICAL 20100824 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 1.5; 9.13 mL/100mL; mL/100mL; mL/100mL 61957-9401_481160f2-ed3e-46e3-990d-944973f0e729 61957-9401 HUMAN OTC DRUG DIORPRESTIGE WHITE COLLECTION SATIN BRIGHTENING UV BASE SPF 50 TITANIUM DIOXIDE, OCTINOXATE, OXYBENZONE CREAM TOPICAL 20111014 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.49; 2; 8.88 mL/100mL; mL/100mL; mL/100mL 61957-9402_06b27520-e8a9-44bc-866c-40149989e5b2 61957-9402 HUMAN OTC DRUG CD Dior Prestige White Collection Satin Brightening UV Base Blemish Balm SPF 50 TITANIUM DIOXIDE, OCTINOXATE, OXYBENZONE CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.49; 2; 4.26 mL/100mL; mL/100mL; mL/100mL 61957-9403_0bc76625-cbf2-4df0-a175-ebb4f3529370 61957-9403 HUMAN OTC DRUG CD DIOR PRESTIGE WHITE COLLECTION SATIN BRIGTNENING COMPACT UVB PROTECTION SUNSCREEEN BLEMISH BALM SPF 30 OCTINOXATE CREAM TOPICAL 20120621 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 5.49 g/100g 61957-9404_29c3135c-1f49-4f3d-930a-2a562e9b2a14 61957-9404 HUMAN OTC DRUG CD DIOR PRESTIGE WHITE COLLECTION SATIN BRIGHTENING UVB BASE WITH SUNSCREEN SPF 50 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 74.9; 20; 88.8 mg/mL; mg/mL; mg/mL 61958-0101_cc1a8d88-6b17-49dd-9e47-a19a3a4b0f44 61958-0101 HUMAN PRESCRIPTION DRUG Vistide CIDOFOVIR INJECTION INTRAVENOUS 19960626 NDA NDA020638 Gilead Sciences, Inc. CIDOFOVIR 75 mg/mL Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient] 61958-0401_5c7ad8e3-2087-4136-a59b-916a660def12 61958-0401 HUMAN PRESCRIPTION DRUG Viread TENOFOVIR DISOPROXIL FUMARATE TABLET, COATED ORAL 20011026 NDA NDA021356 Gilead Sciences, Inc. TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 61958-0403_5c7ad8e3-2087-4136-a59b-916a660def12 61958-0403 HUMAN PRESCRIPTION DRUG Viread TENOFOVIR DISOPROXIL FUMARATE POWDER ORAL 20120118 NDA NDA022577 Gilead Sciences, Inc. TENOFOVIR DISOPROXIL FUMARATE 40 mg/g Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 61958-0404_5c7ad8e3-2087-4136-a59b-916a660def12 61958-0404 HUMAN PRESCRIPTION DRUG Viread TENOFOVIR DISOPROXIL FUMARATE TABLET, COATED ORAL 20120118 NDA NDA021356 Gilead Sciences, Inc. TENOFOVIR DISOPROXIL FUMARATE 150 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 61958-0405_5c7ad8e3-2087-4136-a59b-916a660def12 61958-0405 HUMAN PRESCRIPTION DRUG Viread TENOFOVIR DISOPROXIL FUMARATE TABLET, COATED ORAL 20120118 NDA NDA021356 Gilead Sciences, Inc. TENOFOVIR DISOPROXIL FUMARATE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 61958-0406_5c7ad8e3-2087-4136-a59b-916a660def12 61958-0406 HUMAN PRESCRIPTION DRUG Viread TENOFOVIR DISOPROXIL FUMARATE TABLET, COATED ORAL 20120118 NDA NDA021356 Gilead Sciences, Inc. TENOFOVIR DISOPROXIL FUMARATE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 61958-0501_22dc9759-59c6-4683-a461-6cdea36beabf 61958-0501 HUMAN PRESCRIPTION DRUG Hepsera adefovir dipivoxil TABLET ORAL 20020920 NDA NDA021449 Gilead Sciences, Inc. ADEFOVIR DIPIVOXIL 10 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 61958-0601_d13d8fe9-041c-442f-ab93-65cba4fe069e 61958-0601 HUMAN PRESCRIPTION DRUG Emtriva EMTRICITABINE CAPSULE ORAL 20030702 NDA NDA021500 Gilead Sciences, Inc. EMTRICITABINE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 61958-0602_d13d8fe9-041c-442f-ab93-65cba4fe069e 61958-0602 HUMAN PRESCRIPTION DRUG Emtriva EMTRICITABINE SOLUTION ORAL 20050928 NDA NDA021896 Gilead Sciences, Inc. EMTRICITABINE 10 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 61958-0701_0aba246d-a063-4784-ba41-66842dfc4baf 61958-0701 HUMAN PRESCRIPTION DRUG Truvada emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20040802 NDA NDA021752 Gilead Sciences, Inc EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 61958-0801_17455b7d-3125-4d06-9b1a-b60c79b1a8d3 61958-0801 HUMAN PRESCRIPTION DRUG Letairis AMBRISENTAN TABLET, FILM COATED ORAL 20070615 NDA NDA022081 Gilead Sciences, Inc AMBRISENTAN 5 mg/1 Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA] 61958-0802_17455b7d-3125-4d06-9b1a-b60c79b1a8d3 61958-0802 HUMAN PRESCRIPTION DRUG Letairis AMBRISENTAN TABLET, FILM COATED ORAL 20070615 NDA NDA022081 Gilead Sciences, Inc AMBRISENTAN 10 mg/1 Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA] 61958-0901_0d2b8cc7-2781-44e4-8aa7-f613eebb87db 61958-0901 HUMAN PRESCRIPTION DRUG Cayston aztreonam KIT 20100222 NDA NDA050814 Gilead Sciences, Inc. 61958-1001_91f49ac7-d683-4c63-9b79-355c13cc28e4 61958-1001 HUMAN PRESCRIPTION DRUG Ranexa ranolazine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060127 NDA NDA021526 Gilead Sciences, Inc. RANOLAZINE 500 mg/1 Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 61958-1002_91f49ac7-d683-4c63-9b79-355c13cc28e4 61958-1002 HUMAN PRESCRIPTION DRUG Ranexa ranolazine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070212 NDA NDA021526 Gilead Sciences, Inc. RANOLAZINE 1000 mg/1 Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 61958-1003_23a97e33-d8e4-47c8-b924-ae1897b73f60 61958-1003 HUMAN PRESCRIPTION DRUG Ranexa RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060127 NDA NDA021526 Gilead Sciences, Inc. RANOLAZINE 500 mg/1 Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 61958-1004_23a97e33-d8e4-47c8-b924-ae1897b73f60 61958-1004 HUMAN PRESCRIPTION DRUG Ranexa RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070212 NDA NDA021526 Gilead Sciences, Inc. RANOLAZINE 1000 mg/1 Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 61958-1101_528b4b73-8198-4d16-8397-774726e04b60 61958-1101 HUMAN PRESCRIPTION DRUG COMPLERA emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20110810 NDA NDA202123 Gilead Sciences, Inc. EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE 200; 25; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [Chemical/Ingredient],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 61958-1201_dff0ca5a-35f6-4ce2-b0ba-54951d1e8169 61958-1201 HUMAN PRESCRIPTION DRUG Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20120827 NDA NDA203100 Gilead Sciences, Inc. COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 150; 150; 200; 300 mg/1; mg/1; mg/1; mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 61958-1301_ce7a4e8a-7b24-4ed3-bc8b-bbe897f63299 61958-1301 HUMAN PRESCRIPTION DRUG Vitekta ELVITEGRAVIR TABLET, FILM COATED ORAL 20140924 NDA NDA203093 Gilead Sciences, Inc. ELVITEGRAVIR 85 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] 61958-1302_ce7a4e8a-7b24-4ed3-bc8b-bbe897f63299 61958-1302 HUMAN PRESCRIPTION DRUG Vitekta ELVITEGRAVIR TABLET, FILM COATED ORAL 20140924 NDA NDA203093 Gilead Sciences, Inc. ELVITEGRAVIR 150 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] 61958-1401_94a35558-4348-4ae9-b0a8-8ab19d11d7ba 61958-1401 HUMAN PRESCRIPTION DRUG Tybost COBICISTAT TABLET, FILM COATED ORAL 20140924 NDA NDA203094 Gilead Sciences, Inc. COBICISTAT 150 mg/1 61958-1501_7cc486b0-ccc1-478b-9fa8-0e6a2fbf0786 61958-1501 HUMAN PRESCRIPTION DRUG Sovaldi SOFOSBUVIR TABLET, FILM COATED ORAL 20131206 NDA NDA204671 Gilead Sciences, Inc. SOFOSBUVIR 400 mg/1 61958-1701_144811c7-17d2-4836-b3ce-9f867186eea9 61958-1701 HUMAN PRESCRIPTION DRUG Zydelig idelalisib TABLET, FILM COATED ORAL 20140723 NDA NDA205858 Gilead Sciences, Inc. IDELALISIB 100 mg/1 61958-1702_144811c7-17d2-4836-b3ce-9f867186eea9 61958-1702 HUMAN PRESCRIPTION DRUG Zydelig idelalisib TABLET, FILM COATED ORAL 20140723 NDA NDA205858 Gilead Sciences, Inc. IDELALISIB 150 mg/1 61958-1801_31caf81f-bab4-467e-a4ac-a1b7ae0e138a 61958-1801 HUMAN PRESCRIPTION DRUG Harvoni LEDIPASVIR and SOFOSBUVIR TABLET, FILM COATED ORAL 20141010 NDA NDA205834 Gilead Sciences, Inc LEDIPASVIR; SOFOSBUVIR 90; 400 mg/1; mg/1 61971-065_3da92ae2-eef2-4f93-bb7c-0edc451c783b 61971-065 HUMAN PRESCRIPTION DRUG ISOXSUPRINE HYDROCHLORIDE Isoxsuprine hydrochloride TABLET ORAL 19970919 UNAPPROVED DRUG OTHER Vista Pharmaceuticals, Inc. ISOXSUPRINE HYDROCHLORIDE 20 mg/1 61971-115_1b7c5b37-792a-46a3-9d1e-f23c34c28242 61971-115 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20060606 ANDA ANDA076817 Vista Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 61971-120_1b7c5b37-792a-46a3-9d1e-f23c34c28242 61971-120 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20060822 ANDA ANDA076817 Vista Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 61979-001_edc56476-093f-47c2-a05c-cfe338f67da6 61979-001 HUMAN OTC DRUG BODY TIME Anti-Aging Day Cream SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20140718 OTC MONOGRAPH NOT FINAL part352 Bela Vida Holdings, LLC dba Body Time AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL 61995-0029_2c13e59a-1215-4fcd-9864-87e0c8b444af 61995-0029 HUMAN OTC DRUG Jason Dandruff Relief Treatment 2 in 1 Zinc Pyrithione SHAMPOO TOPICAL 20120419 OTC MONOGRAPH FINAL part358H The Hain Celestial Group, Inc PYRITHIONE ZINC 1 g/100g 61995-0101_7d8a9963-9123-44ed-84b3-f8118a7f740f 61995-0101 HUMAN OTC DRUG Jason Powersmile Anticavity ,Whitening Powerful Peppermint Sodium Monofluorophosphate GEL ORAL 20110920 OTC MONOGRAPH FINAL part355 The Hain Celestial Group, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 61995-0102_ff155c43-e5a8-4546-bbfa-2623d21fb634 61995-0102 HUMAN OTC DRUG Jason Nutrismile Anticavity Orange Cinnamon Mint Sodium Monofluorophosphate GEL ORAL 20110920 OTC MONOGRAPH FINAL part355 The Hain Celestial Group, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 61995-0103_4f83da8e-94d5-4760-a037-8286b70846ce 61995-0103 HUMAN OTC DRUG Jason Healthy Mouth Anticavity ,Tartar Control Tea Tree Oil and Cinnamon Sodium Monofluorophosphate GEL ORAL 20110920 OTC MONOGRAPH FINAL part355 The Hain Celestial Group, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 61995-0104_ea161207-146e-4910-8512-475a3135d6b6 61995-0104 HUMAN OTC DRUG Jason Sea Fresh Anticavity Strengthening Deep Sea Spearmint Sodium Monofluorophosphate GEL ORAL 20110920 OTC MONOGRAPH FINAL part355 The Hain Celestial Group, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 61995-0201_bc73fb11-75b9-4c9e-afac-e844468cc930 61995-0201 HUMAN OTC DRUG Sunbrellas Sport Sunblock SPF 45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide CREAM TOPICAL 20091103 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 10; 7.5; 5; 10; 2 g/100g; g/100g; g/100g; g/100g; g/100g 61995-0204_a4c30581-5f39-462a-905e-26f51673d47a 61995-0204 HUMAN OTC DRUG Sunbrellas Kids Sunblock SPF 45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide CREAM TOPICAL 20091103 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 10; 7.5; 5; 10; 2 g/100g; g/100g; g/100g; g/100g; g/100g 61995-0205_171017ae-3da7-4034-a777-e1e980a1a17c 61995-0205 HUMAN OTC DRUG Sunbrellas Family Sunblock SPF 45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide CREAM TOPICAL 20091103 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 10; 7.5; 5; 10; 2 g/100g; g/100g; g/100g; g/100g; g/100g 61995-0209_300341ef-89c6-4232-800e-da3a3ea21c1e 61995-0209 HUMAN OTC DRUG Jason Facial Natural Sunscreen Broad Spectrum SPF20 Homosalate, Octocrylene, Ethylhexyl Salicylate, Titanium Dioxide LOTION TOPICAL 20110811 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 3; 5; 2 g/100g; g/100g; g/100g; g/100g 61995-0210_5e1a480f-79cb-46fe-90ae-9f1031ebec33 61995-0210 HUMAN OTC DRUG Sunbrellas Mineral Sunblock SPF 30 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20091103 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 2; 14.5 g/100g; g/100g 61995-0212_13623c75-93cd-4ab3-a056-5db8830784c4 61995-0212 HUMAN OTC DRUG Earths Best Mineral Sunscreen Broad Spectrum SPF30 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20111019 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 2; 14.5 g/100g; g/100g 61995-0300_1916a20a-1f26-4a63-a381-8241253d1a8c 61995-0300 HUMAN OTC DRUG Jason Pure Natural Sun Family Natural Sunscreen Broad Spectrum SPF45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide LOTION TOPICAL 20110911 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 10; 7.5; 5; 10; 2 g/100g; g/100g; g/100g; g/100g; g/100g 61995-0302_7c693996-704a-40f0-804f-313cb3561bef 61995-0302 HUMAN OTC DRUG Jason Dandruff Relief Treatment Sulfur, Salicylic Acid SHAMPOO TOPICAL 20100105 OTC MONOGRAPH FINAL part358H The Hain Celestial Group, Inc SALICYLIC ACID; SULFUR 2; 2 g/100g; g/100g 61995-0315_b29685a5-2ed8-495a-b1c9-03ac4f95bb91 61995-0315 HUMAN OTC DRUG Jason Pure Natural Sun Mineral Natural Sunscreen Broad Spectrum SPF30 Zinc Oxide, Titanium Oxide LOTION TOPICAL 20110820 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 2; 14.5 g/100g; g/100g 61995-0320_bac82772-0ace-4e0e-a95f-4ea9b35e6a5f 61995-0320 HUMAN OTC DRUG Jason Pure Natural Sun Sport Natural Sunscreen Broad Spectrum SPF45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide LOTION TOPICAL 20110810 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 10; 7.5; 5; 10; 2 g/100g; g/100g; g/100g; g/100g; g/100g 61995-0322_9858b698-44e0-4768-8002-d1e9e9eb7b95 61995-0322 HUMAN OTC DRUG Jason Pure Natural Sun Kids Natural Sunscren Broad Spectrum SPF45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide LOTION TOPICAL 20110811 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 10; 7.5; 5; 10; 2 g/100g; g/100g; g/100g; g/100g; g/100g 61995-0405_18f6ce5d-f4be-4767-9a54-b86d3ed30a15 61995-0405 HUMAN OTC DRUG Earths Best Diaper Relief Zinc Oxide OINTMENT TOPICAL 20110930 OTC MONOGRAPH FINAL part347 The Hain Celestial Group, Inc ZINC OXIDE 21 g/100g 61995-0602_39b4d801-758a-4671-b063-300483ec09a0 61995-0602 HUMAN OTC DRUG Jason Cooling Minerals and Tea Tree Pain Therapy Methyl Salicylate OINTMENT TOPICAL 20110923 OTC MONOGRAPH FINAL part348 The Hain Celestial Group, Inc METHYL SALICYLATE 13.5 g/100g 61995-0758_de6c79e0-dfe2-4e13-9edf-0b0c3703a7f4 61995-0758 HUMAN OTC DRUG Earths Best Cold Relief Vapor Camphor, Menthol, Eucalyptus Globulus Leaf Oil OINTMENT TOPICAL 20110913 OTC MONOGRAPH FINAL part341 The Hain Celestial Group, Inc CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 5.3; 1.3; 2.8 g/100g; g/100g; g/100g 61995-0832_0af9fecf-1dcb-4944-e054-00144ff88e88 61995-0832 HUMAN OTC DRUG Jason Sun Sport Sunscreen Broad Spectrum SPF45 Homosalate, Octinoxate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20140304 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 3; 10; 7.5; 5; 7; 1 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 61995-1106_d7a25e70-c31d-4d68-bd26-6e9ba37fc463 61995-1106 HUMAN OTC DRUG Anti Dandruff Salicylic Acid SHAMPOO TOPICAL 20140129 OTC MONOGRAPH FINAL part358H The Hain Celestial Group, Inc. SALICYLIC ACID 2 g/414g 61995-1107_6c2a2513-2af4-4673-9212-630670f0c91c 61995-1107 HUMAN OTC DRUG Anti Dandruff Salicylic Acid RINSE TOPICAL 20140117 OTC MONOGRAPH FINAL part358H The Hain Celestial Group, Inc. SALICYLIC ACID 2 g/397g 61995-1110_78ffc894-e69c-4445-a32c-d271d7ceb8ed 61995-1110 HUMAN OTC DRUG Avalon Organics Baby Protective Zinc Diaper Balm Zinc Oxide CREAM TOPICAL 20111018 OTC MONOGRAPH FINAL part347 The Hain Celestial Group, Inc ZINC OXIDE 21 g/100g 61995-1125_69b7dab0-eaff-434b-9138-995a6d6a5962 61995-1125 HUMAN PRESCRIPTION DRUG AV3712501 Mineral Sunscreen SPF 18 Titanium Dioxide CREAM TOPICAL 20060301 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE 7 g/100g 61995-1320_77fd2284-4b2b-41a0-8dc8-e0fd42d2f00d 61995-1320 HUMAN OTC DRUG Avalon Organics Lavender Luminosity Moisture Plus SPF15 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20111018 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 2; 7.5 g/100g; g/100g 61995-1386_92fd8db4-79e5-4506-8ef0-e6cc6c7a0928 61995-1386 HUMAN OTC DRUG Avalon Organics Vitamin C Renewal Moisture Plus SPF15 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20111018 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 2; 7.5 g/100g; g/100g 61995-1805_0318396b-f0d2-41a9-ac55-64f3ba4523ec 61995-1805 HUMAN OTC DRUG Avalon Organics COQ10 Repair Wrinkle Defense Broad Spectrum SPF15 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20110615 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 2; 7.5 g/100g; g/100g 61995-2025_08c86fc6-47a4-288b-e054-00144ff88e88 61995-2025 HUMAN OTC DRUG Alba HW Sunscreen Soothing Aloe Vera SPF30 Homosalate, Octisalate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20140213 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 3; 7.5; 5; 7.5; 1 g/100g; g/100g; g/100g; g/100g; g/100g 61995-2031_08c9a0cf-ee77-483b-e054-00144ff88e88 61995-2031 HUMAN OTC DRUG Alba Even Advanced Sea Moss Moisturizer SPF15 Homosalate, Ethylhexyl Salicylate, Octocrylene, Butyl Methoxydibenzoylmethane LOTION TOPICAL 20140113 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 7.5; 5; 3 g/100g; g/100g; g/100g; g/100g 61995-2032_06338be6-bfe0-3c44-e054-00144ff8d46c 61995-2032 HUMAN OTC DRUG Alba Even Advanced Mineral CC Cream Light to Medium SPF15 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130725 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 3.5; 4 g/100g; g/100g 61995-2037_06aa0fa5-1c2f-485b-e054-00144ff88e88 61995-2037 HUMAN OTC DRUG Alba Body Daily Shade SPF15 Homosalate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane LOTION TOPICAL 20131111 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 7.5; 5; 3 g/100g; g/100g; g/100g; g/100g 61995-2037_06fc3869-3fe0-5d2f-e054-00144ff8d46c 61995-2037 HUMAN OTC DRUG Alba Body Daily Shade SPF15 Homosalate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane LOTION TOPICAL 20131111 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 7.5; 5; 3 g/100g; g/100g; g/100g; g/100g 61995-2039_079ce9f7-406e-28cd-e054-00144ff8d46c 61995-2039 HUMAN OTC DRUG Alba VE Sunscreen Sport SPF45 Homosalate, Octinoxate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20140520 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 3; 10; 7.5; 5; 10; 1 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 61995-2082_07da8cea-100b-7195-e054-00144ff8d46c 61995-2082 HUMAN OTC DRUG Alba Hawaiian Sunscreen Green Tea SPF45 Homosalate, Octinoxate, Ethylhexyl Salicylate, Octocrylene, Butyl Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20131028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 3; 10; 7.5; 5; 10; 1 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 61995-2091_07d72e69-417a-3268-e054-00144ff88e88 61995-2091 HUMAN OTC DRUG Alba VE Sunscreen SPF30 Fragrance Free Homosalate, Ethylhexyl Salicylate, Octocrylene, Butyl Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 3; 7.5; 5; 7.5; 1 g/100g; g/100g; g/100g; g/100g; g/100g 61995-2095_08b403aa-fc48-2ac7-e054-00144ff8d46c 61995-2095 HUMAN OTC DRUG Alba VE Facial Sunscreen SPF30 Homosalate, Octisalate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 3; 7.5; 5; 7.5; 1 g/100g; g/100g; g/100g; g/100g; g/100g 61995-2102_d013384d-aefb-4661-ab37-0f1860d218d0 61995-2102 HUMAN OTC DRUG Alba HawaiianDry Sunscreen SPF15 Homosalate, Octisalate, Octocrylene, Avobenzone OIL TOPICAL 20140114 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 3 g/133g; g/133g; g/133g; g/133g 61995-2312_689b437a-207a-469b-9d1b-93279bce233d 61995-2312 HUMAN OTC DRUG Alba Botanica Natural Even Advanced Sea Moss Moisturizer SPF15 Homosalate, Octocrylene, Ethylhexyl Salicylate LOTION TOPICAL 20110602 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE 7.5; 5; 5 g/100g; g/100g; g/100g 61995-2328_0608ed7f-47f8-4c19-e054-00144ff88e88 61995-2328 HUMAN OTC DRUG Alba Even Advanced Mineral CC Cream Fair to Light SPF15 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130725 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 3.5; 4 g/100g; g/100g 61995-2329_83efe10f-ee4b-42f7-a57b-1c8ac81e549e 61995-2329 HUMAN OTC DRUG Alba Botanica UN-petroleum Tangerine SPF18 Lip Balm Ethylhexyl Dimethyl PABA, Benzophenone-3 STICK TOPICAL 20111102 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. OXYBENZONE; PADIMATE O 5; 7.5 g/100g; g/100g 61995-2371_632dbe73-b92d-4b92-b892-1b694451bbbb 61995-2371 HUMAN OTC DRUG Alba Botanica Natural Very Emollient Daily Shade SPF15 Homosalate, Ethylhexyl Salicylate, Octocrylene LOTION TOPICAL 20111018 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE 7.5; 5; 3 g/100g; g/100g; g/100g 61995-2383_13a42682-9ef2-4aba-93b5-76f19b394c9d 61995-2383 HUMAN OTC DRUG Alba Botanica Natural Very Emollient Sunscreen Sport Spray SPF40 Homosalate, Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane LOTION TOPICAL 20111229 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 12; 7.5; 5; 7 g/100g; g/100g; g/100g; g/100g; g/100g 61995-2385_76bcd7c2-396b-4fa2-a5bd-faf5fe49dcb8 61995-2385 HUMAN OTC DRUG Alba Botanica Natural Very Emollient Sunscreen Kids SPF40 Homosalate, Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane SPRAY TOPICAL 20111229 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 12; 7.5; 5; 7 g/100g; g/100g; g/100g; g/100g; g/100g 61995-2387_f387c938-12d9-48ce-9ae9-4589d59a2cc9 61995-2387 HUMAN OTC DRUG Alba Sunblock Facial SPF 20 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 1; 8 g/100g; g/100g 61995-2388_200300f5-b280-46ec-a9ea-a7ca55d8d3e0 61995-2388 HUMAN OTC DRUG Alba Kids Mineral Sunblock SPF 30 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 2; 14.5 g/100g; g/100g 61995-2389_b0c449e5-00c7-4070-a171-17e678b63158 61995-2389 HUMAN OTC DRUG Alba Sunblock Mineral FF SPF 30 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20091116 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 2; 14.5 g/100g; g/100g 61995-2390_a0748931-d37a-49dd-92ad-631ddc22260b 61995-2390 HUMAN OTC DRUG Alba Sunblock Natural Sport SPF 45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 10; 7.5; 5; 10; 2 g/100g; g/100g; g/100g; g/100g; g/100g 61995-2391_5966a1a7-67e7-4097-87a9-9bb64263254f 61995-2391 HUMAN OTC DRUG Alba Sunblock Natural FF SPF 30 Homosalate, Octocrylene, Ethylhexyl Salicilate, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 5; 7.5; 2 g/100g; g/100g; g/100g; g/100g 61995-2392_562ba25c-6570-491b-94e5-f8a0a1d55ecd 61995-2392 HUMAN PRESCRIPTION DRUG Alba Sunblock Mineral Aloe Vanilla SPF 30 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 1; 12 g/100g; g/100g Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 61995-2393_cb88c9aa-1fd4-4e63-aafc-ebdcdea3679e 61995-2393 HUMAN OTC DRUG Alba Sunblock Natural Lavender SPF 45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 10; 7.5; 5; 10; 2 g/100g; g/100g; g/100g; g/100g; g/100g 61995-2394_c330b16e-974e-4edc-8f12-3a4237223b21 61995-2394 HUMAN OTC DRUG Alba Lip Care Sunblock SPF 25 Octocrylene, Ethylhexyl Methoxycinnamate, Zinc Oxide, Ethylhexyl Salicilate CREAM TOPICAL 20091027 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 7.5; 1; 10; 3.9 g/100g; g/100g; g/100g; g/100g 61995-2395_0c677cd4-6b66-4b56-9a3c-303349b7e69d 61995-2395 HUMAN OTC DRUG Alba Sunblock Natural Facial SPF 30 Homosalate, Octocrylene, Ethylhexyl Salicilate, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 5; 7.5; 2 g/100g; g/100g; g/100g; g/100g 61995-2399_83504559-36b1-4acf-9ac9-f192e6939bca 61995-2399 HUMAN OTC DRUG Alba Sunblock Natural Kids SPF 45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide CREAM TOPICAL 20091228 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 10; 7.5; 5; 10; 2 g/100g; g/100g; g/100g; g/100g; g/100g 61995-2400_05680826-a5ef-6685-e054-00144ff88e88 61995-2400 HUMAN OTC DRUG Alba Mineral Sunscreen Sport SPF45 Broad Spectrum Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 9 g/100g; g/100g 61995-2500_03a98f64-9563-66c3-e054-00144ff8d46c 61995-2500 HUMAN OTC DRUG Alba Mineral Terra Tint SPF15 Blaze Zinc Oxide CREAM TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE 5.5 g/100g 61995-2515_044f0375-feda-502a-e054-00144ff88e88 61995-2515 HUMAN OTC DRUG Alba Mineral Terr Tint SPF15 Bloom Zinc Oxide CREAM TOPICAL 20130816 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE 5.5 g/100g 61995-2535_04f0d499-26fb-1d4c-e054-00144ff88e88 61995-2535 HUMAN OTC DRUG Alba Mineral Terra Tint SPF15 Garnet Zinc Oxide CREAM TOPICAL 20130816 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE 5.5 g/100g 61995-2760_b0cd0065-30a1-49e1-b3f4-7c9832b91825 61995-2760 HUMAN OTC DRUG Alba Natural Acnedote Wash Salicylic Acid LOTION TOPICAL 20100121 OTC MONOGRAPH FINAL part333 The Hain Celestial Group, Inc. SALICYLIC ACID 2 mL/100mL 61995-2761_ef83a032-3c67-4fb1-ad10-94f90e5acbe5 61995-2761 HUMAN OTC DRUG Alba Natural Acnedote Face Body Scrub Salicylic Acid CREAM TOPICAL 20100121 OTC MONOGRAPH FINAL part333 The Hain Celestial Group, Inc. SALICYLIC ACID 2 g/100g 61995-2762_55c594f6-52c0-42d9-8b0c-9349dc3b3f24 61995-2762 HUMAN OTC DRUG Alba Natural Acnedote Salicylic Acid LOTION TOPICAL 20100218 OTC MONOGRAPH FINAL part333 The Hain Celestial Group, Inc. SALICYLIC ACID 2 g/100g 61995-2763_ea077ef0-b2ff-47be-94d2-e8bb9e346539 61995-2763 HUMAN OTC DRUG Alba Natural Acnedote Astringent Salicylic Acid LOTION TOPICAL 20100121 OTC MONOGRAPH FINAL part333 The Hain Celestial Group, Inc. SALICYLIC ACID 2 mL/100mL 61995-2764_0784dc3a-2d53-2cee-e054-00144ff8d46c 61995-2764 HUMAN OTC DRUG Alba Acnedote Invisible Treatment Salicylic Acid LOTION TOPICAL 20131001 OTC MONOGRAPH FINAL part333D The Hain Celestial Group, Inc. SALICYLIC ACID 2 g/100g 61995-2765_082758ac-3e51-11fd-e054-00144ff88e88 61995-2765 HUMAN OTC DRUG Alba Acnedote Clean Treat Towelette Salicylic Acid CLOTH TOPICAL 20131126 OTC MONOGRAPH FINAL part333D The Hain Celestial Group, Inc. SALICYLIC ACID 2 g/301 61995-2766_0863929c-3a2a-576c-e054-00144ff88e88 61995-2766 HUMAN OTC DRUG Alba Acnedote Clean Treat Cleansing Towelette Salicylic Acid CLOTH TOPICAL 20131126 OTC MONOGRAPH FINAL part333D The Hain Celestial Group, Inc. SALICYLIC ACID 2 g/101 61995-2781_07364a19-a71c-23c9-e054-00144ff88e88 61995-2781 HUMAN OTC DRUG Alba Good and Clean Gentle Acne Wash Salicylic Acid LOTION TOPICAL 20130307 OTC MONOGRAPH FINAL part333D The Hain Celestial Group, Inc. SALICYLIC ACID 1 g/100g 61995-2789_06840628-9ec3-04f7-e054-00144ff88e88 61995-2789 HUMAN OTC DRUG Alba Good and Healthy Moisturizer SPF15 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20140127 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 3.7; 4.8 g/100g; g/100g 61995-2825_bc29f36b-aab4-4ac8-bded-15e7bc853348 61995-2825 HUMAN OTC DRUG Alba Hawaiian Aloe Vera Sunblock SPF 30 Homosalate, Octocrylene, Ethylhexyl Salicylate, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 5; 7.5; 2 g/100g; g/100g; g/100g; g/100g 61995-2827_d95663fa-e39b-4bf7-9dd1-37f9854187cc 61995-2827 HUMAN OTC DRUG Alba Hawaiian Green Tea Sunblock SPF 45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 10; 7.5; 5; 10; 2 g/100g; g/100g; g/100g; g/100g; g/100g 61995-2831_85846e1f-75fa-47bd-9604-ee15b6e95723 61995-2831 HUMAN OTC DRUG Alba Hawaiian Coconut Siscreen SPF 15 Homosalate, Ethylhexyl Salicylate, Octocrylene CREAM TOPICAL 20091117 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE 10; 5; 3 g/100g; g/100g; g/100g 61995-2921_30695b6c-a104-441c-bc7b-39b6e86fcfc2 61995-2921 HUMAN OTC DRUG Alba Botanica UN-petroleum Vanilla SPF18 Lip Balm Ethylhexyl Dimethyl PABA, Benzophenone-3 STICK TOPICAL 20111102 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. OXYBENZONE; PADIMATE O 5; 7.5 g/100g; g/100g 61995-2923_8971c6ba-f016-47cb-bb7b-1efed0861686 61995-2923 HUMAN OTC DRUG Alba Botanica UN-petroleum Cherry SPF18 Lip Balm Ethylhexyl Dimethyl PABA, Benzophenone-3 STICK TOPICAL 20111102 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. OXYBENZONE; PADIMATE O 5; 7.5 g/100g; g/100g 61995-6110_51d96dff-39c9-4857-bf55-ee14ec98b219 61995-6110 HUMAN OTC DRUG Avalon Organics Essential Lift Firming Moisturizer SPF15 Zinc Oxide LOTION TOPICAL 20111018 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE 8.5 g/100g 62000-321_918af033-f8ca-4173-b887-f1c9ef70fa98 62000-321 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS Medical Home Care, Inc OXYGEN 99.6 L/100L 62001-0318_0e9551ee-2843-451b-9c48-5cebdfcb75c8 62001-0318 HUMAN OTC DRUG Medic Ice Menthol GEL TOPICAL 20040824 OTC MONOGRAPH NOT FINAL part348 Straight Arrow Products, Inc. MENTHOL .07 g/g 62001-0319_0f2ea8af-99e9-4d7f-a023-f2018510e3d1 62001-0319 HUMAN OTC DRUG Mane n Tail Daily Control Anti-Dandruff Pyrithione Zinc SHAMPOO, SUSPENSION TOPICAL 20080420 OTC MONOGRAPH FINAL part358H Straight Arrow Products, Inc. PYRITHIONE ZINC .01 g/g 62001-0320_13ed15a6-65cf-4814-80ed-cc7309181af0 62001-0320 HUMAN OTC DRUG The Original Mane n Tail Daily Control Anti Dandruff Conditioner Pyrithione Zinc RINSE TOPICAL 20080420 OTC MONOGRAPH FINAL part358H Straight Arrow Products, Inc. PYRITHIONE ZINC .005 g/g 62001-0321_7f5b2298-25cc-4c5f-bf05-1ffe51b3990d 62001-0321 HUMAN OTC DRUG Mane n Tail Daily Control 2 in 1 Anti Dandruff Shampoo Conditioner Pyrithione Zinc SHAMPOO TOPICAL 20090320 OTC MONOGRAPH FINAL part358H Straight Arrow Products, Inc. PYRITHIONE ZINC .01 g/g 62003-001_0935f36f-52db-42ec-ba9d-d98874cff723 62003-001 HUMAN OTC DRUG Coldaid menthol GRANULE, FOR SOLUTION ORAL 20101201 OTC MONOGRAPH NOT FINAL part356 PRINCE OF PEACE ENTERPRISES INC. MENTHOL 490 mg/5g 62003-002_7dc7752a-ef40-40c3-8571-c8b1d6162469 62003-002 HUMAN OTC DRUG Fluaid menthol GRANULE, FOR SOLUTION ORAL 20101201 OTC MONOGRAPH NOT FINAL part356 PRINCE OF PEACE ENTERPRISES INC. MENTHOL 270 mg/6g 62003-422_0471b450-8f47-406a-b988-12894bdf8c0b 62003-422 HUMAN OTC DRUG Tiger Balm Arthritis Rub Camphor (Synthetic) and Menthol CREAM TOPICAL 20020610 OTC MONOGRAPH FINAL part348 Prince of Peace Enterprises, Inc. CAMPHOR (SYNTHETIC); MENTHOL 110; 110 mg/mL; mg/mL 62003-888_31f96d1d-f2a0-491c-80a5-f527885c0c4b 62003-888 HUMAN OTC DRUG Han Honey Loquat Syrup menthol SYRUP ORAL 20140501 OTC MONOGRAPH NOT FINAL part356 PRINCE OF PEACE ENTERPRISES INC. MENTHOL .1 g/100mL 62007-001_7eab8df6-d52e-4c6d-b41b-ed90d498e3fa 62007-001 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL BANANA BERRY FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg 62007-004_1d9fec6c-0db4-40c6-9269-5e7b89039b30 62007-004 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL MOCHA CAPPUCCINO FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg 62007-005_527e74ac-aef1-4399-b599-31d8073aaa69 62007-005 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL MARSHMALLOW FLOAT FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg 62007-006_b2a2cf43-894c-4684-8389-b643e7e6cc84 62007-006 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL CREME DE MENTHE FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg 62007-009_e17e9fcc-df38-4320-9939-10898ec6d834 62007-009 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL RASPBERRY BLAST FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg 62007-010_1acc36ad-588d-4284-a299-88cf4cb6fa5f 62007-010 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL STRAWBERRY BLAST FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg 62007-011_077f5f48-e70c-4e83-ac05-59c35808dd4a 62007-011 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL VANILLA ORANGE FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg 62007-012_7395cc0b-93d5-4933-a102-75fdc7071be5 62007-012 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL GRAPE EXPLOSION FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg 62007-013_5a8301a7-8b01-449f-bfd5-5ad1c95b8dfa 62007-013 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL WATERMELON SPLASH FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg 62007-014_3ebf022d-ebc8-485a-8199-7e085f9f16aa 62007-014 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL COOL PEPPERMINT FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg 62007-015_b52d0568-d6dc-4f22-bac1-43acd440f54a 62007-015 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL LUSCIOUS LIME FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg 62007-020_dd5d39cf-36bd-4492-b725-f1aaf3503cc7 62007-020 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL GEL CREME DE MENTHE FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg 62007-022_885c8518-d122-467b-b907-de2479a46db2 62007-022 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL GEL RASPBERRY BLAST FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg 62007-023_5929cf3f-28ec-4528-b375-68e19357e926 62007-023 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL GEL VANILLA ORANGE FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg 62007-024_047d7981-a94f-4b01-a8c2-46d76b96aede 62007-024 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL GEL PINA COLADA FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg 62007-025_2ff95f0b-eeb9-4783-b87d-24cb21c21758 62007-025 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL GEL COOL PEPPERMINT FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg 62007-026_85133b26-58d9-4d45-8e88-a99e0225265a 62007-026 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL GEL RASPBERRY BLAST FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg 62007-027_9ae05d75-3cc0-4e85-845c-4c5723ad035a 62007-027 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL GEL WATERMELON SPLASH FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg 62007-028_f6bc4581-ef29-4ffe-ba91-be1b92f553ab 62007-028 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL ROOTBEER FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg 62007-029_2a22def9-9017-45d0-865e-d636646bdf12 62007-029 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL GEL MOCHA CAPUCCINO FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg 62007-104_4a4eba66-89c2-4e49-86a2-cfb90be342bd 62007-104 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL FOAM BAZOOKA BUBBLEGUM FLUORIDE TREATMENT AEROSOL, FOAM TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg 62007-105_db6a3378-8e87-43ad-8c82-8a0a985e3b5e 62007-105 HUMAN PRESCRIPTION DRUG PCxx SODIUM FLUORIDE AEROSOL, FOAM DENTAL 20121212 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 2.5 g/125g 62007-210_3e601d61-9ee7-41e9-be41-026389890ac9 62007-210 HUMAN PRESCRIPTION DRUG NEUTRAL RINSE SODIUM FLUORIDE LIQUID TOPICAL 20110901 OTC MONOGRAPH FINAL part355 Ross Healthcare, Inc. SODIUM FLUORIDE 2 mL/100mL 62011-0001_623fa5a0-2ff4-4a6b-a0a9-88896daf1a98 62011-0001 HUMAN OTC DRUG Health Mart infants pain and fever Acetaminophen SUSPENSION ORAL 20111213 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL 62011-0002_aa950513-3123-435f-8f37-284a50e29ef7 62011-0002 HUMAN OTC DRUG health mart pain and fever Acetaminophen LIQUID ORAL 20111122 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL 62011-0003_78aa44ac-3dce-4a03-a2de-a59f47a99b40 62011-0003 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, DELAYED RELEASE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 62011-0004_cb037bc5-405a-4029-8d18-d06c62f87682 62011-0004 HUMAN OTC DRUG health mart ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20111121 ANDA ANDA075217 McKesson IBUPROFEN 50 mg/1.25mL 62011-0005_ca2b6abe-a85d-43f9-b295-e94075c120dc 62011-0005 HUMAN OTC DRUG Health Mart Stay Awake Caffeine TABLET ORAL 20111121 OTC MONOGRAPH FINAL part340 McKesson CAFFEINE 200 mg/1 62011-0006_62f2dee1-68cc-4200-9c72-6eec4371a7d2 62011-0006 HUMAN OTC DRUG Health Mart Maximum Strength Sleep Aid DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20120406 OTC MONOGRAPH FINAL part338 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 62011-0007_95a40b72-842c-4539-ad7f-282e69d10c87 62011-0007 HUMAN OTC DRUG health mart naproxen sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20111121 NDA NDA021920 McKesson NAPROXEN SODIUM 220 mg/1 62011-0010_8850551b-810c-4a0d-a3d9-c39422ee74c6 62011-0010 HUMAN OTC DRUG health mart childrens ibuprofen Ibuprofen SUSPENSION ORAL 20111129 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL 62011-0011_28a862fc-3ccd-403c-a05a-245ba876cb5a 62011-0011 HUMAN OTC DRUG health mart ibuprofen Ibuprofen SUSPENSION ORAL 20111121 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL 62011-0012_c4b84a3b-07c1-4e08-b837-28bfb32bc321 62011-0012 HUMAN OTC DRUG health mart ibuprofen ibuprofen SUSPENSION ORAL 20111121 ANDA ANDA075217 McKesson IBUPROFEN 50 mg/1.25mL 62011-0013_e8fef3d3-329a-403d-8766-ba85f889a1f1 62011-0013 HUMAN OTC DRUG health mart ibuprofen Ibuprofen TABLET, COATED ORAL 20111121 ANDA ANDA077349 McKesson IBUPROFEN 200 mg/1 62011-0014_4cd675aa-70f1-48f9-ab97-4410154ff2ca 62011-0014 HUMAN OTC DRUG health mart ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20111121 ANDA ANDA072096 McKesson IBUPROFEN 200 mg/1 62011-0015_9a5b75bd-536c-42ad-a9b8-41634083b3d4 62011-0015 HUMAN OTC DRUG Health Mart Ibuprofen Ibuprofen TABLET, COATED ORAL 20111121 ANDA ANDA072096 McKesson IBUPROFEN 200 mg/1 62011-0016_93b28bed-f1b4-4d54-84ef-ea70612ef243 62011-0016 HUMAN OTC DRUG IBUPROFEN IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20120409 ANDA ANDA078682 McKesson (Health Mart) IBUPROFEN 200 mg/1 62011-0017_4b34512e-2116-4aa0-854c-957eab5281b4 62011-0017 HUMAN OTC DRUG Health Mart Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20111121 ANDA ANDA074661 McKesson NAPROXEN SODIUM 220 mg/1 62011-0019_df6e395b-ac63-4644-973c-f5f5959f1951 62011-0019 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, DELAYED RELEASE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 62011-0020_9af2085f-a224-4eb1-9c8b-4fc11bdb4f69 62011-0020 HUMAN OTC DRUG Health Mart Aspirin Aspirin TABLET ORAL 20111121 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 325 mg/1 62011-0021_46c80d38-192f-4162-950f-d392775df31d 62011-0021 HUMAN OTC DRUG health mart aspirin Aspirin TABLET, CHEWABLE ORAL 20111121 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 62011-0022_4dc31b06-b50a-406f-896f-0855005b68e4 62011-0022 HUMAN OTC DRUG Health Mart Pain Relief Acetaminophen SUSPENSION ORAL 20111121 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL 62011-0023_129f77ab-39bc-4dd8-b5b4-7634ad68e0b0 62011-0023 HUMAN OTC DRUG Health Mart Pain Relief Acetaminophen TABLET ORAL 20111121 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 62011-0024_ff40259c-4634-4c18-94c6-be365b37b960 62011-0024 HUMAN OTC DRUG Extra Strength Acetaminophen PM ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20120409 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 62011-0025_a9035aad-668a-4612-bf19-d0e2dcdfebec 62011-0025 HUMAN OTC DRUG Extra Strength Acetaminophen PM Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20120604 OTC MONOGRAPH NOT FINAL part343 McKesson (Health Mart) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 62011-0026_5b1ac45c-e54f-4ee6-a3d9-9c3202b98361 62011-0026 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Health Mart ACETAMINOPHEN 650 mg/1 62011-0027_6a313067-3612-41a4-823a-d5263e5f2a2e 62011-0027 HUMAN OTC DRUG health mart pain relief Acetaminophen TABLET, FILM COATED ORAL 20111121 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 62011-0028_3d55baab-702a-44f3-ba96-ac258ee389cd 62011-0028 HUMAN OTC DRUG health mart aspirin Aspirin TABLET, CHEWABLE ORAL 20111121 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 62011-0029_741db3bc-d588-4510-bb8f-3a2a74405de7 62011-0029 HUMAN OTC DRUG Health Mart pain relief Acetaminophen SUSPENSION ORAL 20111121 OTC MONOGRAPH NOT FINAL part343 Mckesson ACETAMINOPHEN 160 mg/5mL 62011-0030_54cbcba4-9fd5-4ab3-a6ab-c148c15758ec 62011-0030 HUMAN OTC DRUG health mart ibuprofen Ibuprofen SUSPENSION ORAL 20111121 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL 62011-0032_49ad9858-a75c-43c5-8005-bcaae51d802d 62011-0032 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 325 mg/1 62011-0035_982b3d84-4e67-4a28-a5ff-0373f419482c 62011-0035 HUMAN OTC DRUG Motion Relief - Less Drowsy Formula MECLIZIN HCl TABLET ORAL 20120626 OTC MONOGRAPH FINAL part336 McKesson (Health Mart) MECLIZINE HYDROCHLORIDE 25 mg/1 62011-0036_129ef163-78c8-4ebf-aaa7-d075651c4107 62011-0036 HUMAN OTC DRUG Original Formula Motion Sickness Relief DIMENHYDRINATE TABLET ORAL 20120626 OTC MONOGRAPH FINAL part336 McKesson (Health Mart) DIMENHYDRINATE 50 mg/1 62011-0037_270147fb-680b-43bd-b652-28274b0308d0 62011-0037 HUMAN OTC DRUG Health Mart Sleep Aid Doxylamine succinate TABLET ORAL 20111121 ANDA ANDA040167 McKesson DOXYLAMINE SUCCINATE 25 mg/1 62011-0038_aa5c52e8-8d57-4ade-9938-c64693c0814c 62011-0038 HUMAN OTC DRUG Health Mart muscle Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part348 McKesson CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g 62011-0040_2b458c14-a40c-4cc6-8aa6-8b814e27ee5c 62011-0040 HUMAN OTC DRUG Health Mart Regular Strength Enteric Coated Aspirin ASPIRIN TABLET, COATED ORAL 20120605 OTC MONOGRAPH NOT FINAL part343 McKesson (Health Mart) ASPIRIN 325 mg/1 62011-0045_ab6dca76-4fd9-4843-8845-07cf18b2ba69 62011-0045 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part333A McKesson Medical ISOPROPYL ALCOHOL .7 mL/1 62011-0047_bd8afc0f-e90d-406a-a0d4-d72143aec6a9 62011-0047 HUMAN OTC DRUG health mart nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20111121 ANDA ANDA078325 McKesson NICOTINE 2 mg/1 62011-0048_dc5b665d-1e4d-459f-9168-c09b11ffe8d4 62011-0048 HUMAN OTC DRUG health mart nicotine Nicotine Polacrilex LOZENGE ORAL 20111121 ANDA ANDA077007 McKesson NICOTINE 2 mg/1 62011-0049_d4f2e75b-16d0-4359-98bd-60ace94c3636 62011-0049 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 62011-0050_af3c3a4d-37f4-41cb-bb17-2823397c4120 62011-0050 HUMAN OTC DRUG HEALTHMART NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 McKesson NICOTINE 7 mg/24h 62011-0051_b43f8ac6-0253-42e2-8d7e-f0db637c963c 62011-0051 HUMAN OTC DRUG Health Mart Pharmacy Childrens Cetirizine Hydrochloride Cetirizine hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Health Mart CETIRIZINE HYDROCHLORIDE 1 mg/mL 62011-0052_9af9e102-bddf-48ba-a636-773f6c665305 62011-0052 HUMAN OTC DRUG 24-Hour All Day Allergy Cetirizine HCl TABLET ORAL 20120427 ANDA ANDA078780 McKesson CETIRIZINE HYDROCHLORIDE 10 mg/1 62011-0053_ecdd6b92-0355-4404-a8a6-573a6625db22 62011-0053 HUMAN OTC DRUG Fiber Psyllium husk CAPSULE ORAL 20120322 OTC MONOGRAPH FINAL part334 Health Mart PSYLLIUM HUSK 520 mg/1 62011-0054_325479b7-092c-4b2b-812b-c5f214556737 62011-0054 HUMAN OTC DRUG health mart allergy complete childrens cetirizine Hydrochloride LIQUID ORAL 20120111 ANDA ANDA090254 McKesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL 62011-0055_e94bebcf-bc0d-4b9a-beb5-f09b602981af 62011-0055 HUMAN OTC DRUG health mart allergy complete d Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20120113 ANDA ANDA077170 McKesson CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 62011-0056_08e57aee-c9b5-47db-83d5-39e99fd195e7 62011-0056 HUMAN OTC DRUG MULTI-SYMPTOM ALLERGY diphenhydramine hydrochloride CAPSULE ORAL 20120214 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 62011-0057_143c085a-6ddf-487b-a260-27069b22d9e6 62011-0057 HUMAN OTC DRUG Health mart allergy childrens Diphenhydramine HCl LIQUID ORAL 20120111 OTC MONOGRAPH FINAL part341 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 62011-0058_71dd6da7-1362-4882-a5cd-f2d70c336406 62011-0058 HUMAN OTC DRUG Allergy DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20120517 OTC MONOGRAPH NOT FINAL part348 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 62011-0059_fde6ad19-9241-462c-9c4d-1bcf9cb13d6a 62011-0059 HUMAN OTC DRUG health mart allergy relief Chlorpheniramine Maleate TABLET ORAL 20120118 OTC MONOGRAPH FINAL part341 McKesson CHLORPHENIRAMINE MALEATE 4 mg/1 62011-0060_e2bac304-8a3a-4964-8f6e-8ff967a726fa 62011-0060 HUMAN OTC DRUG HealthMart Chest Congestion Relief Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Mckesson GUAIFENESIN 400 mg/1 62011-0061_7d9e6223-bc0f-4c28-80ff-8b7144c6c07e 62011-0061 HUMAN OTC DRUG HealthMart Chest Congestion Relief DMDM DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 62011-0062_1c8b3699-c3e1-4583-a20c-81cd8e8bba59 62011-0062 HUMAN OTC DRUG health mart cold and allergy childrens phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20120111 OTC MONOGRAPH FINAL part341 McKesson BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 62011-0063_6f587e40-23b3-4419-b49c-7002fd938e5d 62011-0063 HUMAN OTC DRUG Health Mart Cold and Cough childrens Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20120112 OTC MONOGRAPH FINAL part341 McKesson BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 62011-0065_d9c7aee1-1aea-49ef-852b-1a1cd835f3e4 62011-0065 HUMAN OTC DRUG health mart daytime acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20120111 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 62011-0066_6220593d-a0bd-4395-8df9-2b62a967751a 62011-0066 HUMAN OTC DRUG NON-DROWSY DAY TIME ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED ORAL 20120201 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 62011-0067_1a490cb4-0ac4-4524-80c3-b10e05b38b27 62011-0067 HUMAN OTC DRUG health mart fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20120118 ANDA ANDA076447 McKesson FEXOFENADINE HYDROCHLORIDE 180 mg/1 62011-0068_c16c1d4c-94b8-4eac-8e23-5ace4e36a6d4 62011-0068 HUMAN OTC DRUG Health Mart fexofenadine hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20120126 ANDA ANDA076447 McKesson FEXOFENADINE HYDROCHLORIDE 60 mg/1 62011-0070_27c8311e-e8fc-4685-8119-99cf63be7e0f 62011-0070 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Health Mart IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 62011-0071_211fe879-58f3-434a-b277-e81a1f73cae7 62011-0071 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Health Mart LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 62011-0072_9aea93a6-1122-4bbd-934d-bf8e15aa0964 62011-0072 HUMAN OTC DRUG Health Mart Pharmacy Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Health Mart LORATADINE 5 mg/5mL 62011-0073_47949aaf-807a-4b1a-96e6-2e4f9fe836b5 62011-0073 HUMAN OTC DRUG HealthMart Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Health Mart LORATADINE 10 mg/1 62011-0074_d7a38897-cdb1-4d08-8782-b48c70a56cef 62011-0074 HUMAN OTC DRUG health mart allergy relief Loratadine TABLET ORAL 20120113 ANDA ANDA076301 McKesson LORATADINE 10 mg/1 62011-0075_882e6429-54f2-426a-801d-c6faa10b79d3 62011-0075 HUMAN OTC DRUG Medicated Chest CAMPHOR,EUCALYPTUS OIL,MENTHOL JELLY TOPICAL 20120202 OTC MONOGRAPH FINAL part341 McKesson CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100kg; kg/100kg 62011-0076_5f258f42-e119-4d83-aded-b8c072578205 62011-0076 HUMAN OTC DRUG Health Mart Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130319 ANDA ANDA078912 McKesson GUAIFENESIN 600 mg/1 62011-0077_3518c815-2485-4a22-9931-a62ecf9059d7 62011-0077 HUMAN OTC DRUG health mart nasal decongestant pe Phenylephrine Hydrochloride TABLET ORAL 20111223 OTC MONOGRAPH FINAL part341 McKesson PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 62011-0078_a4fc9bb5-1637-4ed7-94da-e6d813a0e1f8 62011-0078 HUMAN OTC DRUG health mart nasal decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 20111223 OTC MONOGRAPH FINAL part341 McKesson PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 62011-0079_e40938a9-a71a-4bb3-86f3-17843a240b57 62011-0079 HUMAN OTC DRUG health mart nasal oxymetazoline hydrochloride SPRAY NASAL 20120111 OTC MONOGRAPH FINAL part341 McKesson OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 62011-0080_2c9723ed-44d7-4f87-b4eb-e504bfd459a5 62011-0080 HUMAN OTC DRUG health mart nasal oxymetazoline hydrochloride SPRAY NASAL 20120112 OTC MONOGRAPH FINAL part341 McKesson OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 62011-0081_31ba79e7-3b2e-4fbd-b479-6eb633d088c4 62011-0081 HUMAN OTC DRUG health mart nasal Oxymetazoline HCl SPRAY NASAL 20120111 OTC MONOGRAPH FINAL part341 McKesson OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 62011-0082_eecfad89-c9f7-4bc9-88f0-3884d8c1812a 62011-0082 HUMAN OTC DRUG health mart night time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120111 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 62011-0083_01f94c2a-2492-4b1f-bf3a-8578ae61e175 62011-0083 HUMAN OTC DRUG health mart night time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120111 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 62011-0084_eecf5a55-3a93-4f1c-86d9-548ea8854e2a 62011-0084 HUMAN OTC DRUG Health Mart Multi-Symptom Cold and Flu Night Time ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20120409 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 62011-0085_e59a66dc-3935-47f7-834c-e88fb604d79f 62011-0085 HUMAN OTC DRUG health mart nose Phenylephrine hydrochloride LIQUID NASAL 20120111 OTC MONOGRAPH FINAL part341 McKesson PHENYLEPHRINE HYDROCHLORIDE 1 mL/100mL 62011-0087_de7abc65-6399-4379-a570-be05f1f69df0 62011-0087 HUMAN OTC DRUG Health Mart nasal decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120111 ANDA ANDA075153 McKesson PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 62011-0088_9ffc0fe1-155b-40f7-912d-cf7abf797c19 62011-0088 HUMAN OTC DRUG Sore Throat Cherry Phenol LIQUID ORAL 20120101 OTC MONOGRAPH NOT FINAL part356 Health Mart PHENOL 1.5 g/100mL 62011-0089_323e5909-1e1c-4d9d-aa37-9bf94b0720b2 62011-0089 HUMAN OTC DRUG health mart adult tussin Guaifenesin SYRUP ORAL 20120111 OTC MONOGRAPH FINAL part341 McKesson GUAIFENESIN 200 mg/10mL 62011-0090_8bb10f7d-f1a2-4107-839e-984755848df0 62011-0090 HUMAN OTC DRUG health mart adult tussin Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20120124 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 62011-0091_cbc3ee75-b606-48ca-abfa-30a98e7fafac 62011-0091 HUMAN OTC DRUG health mart adult tussin Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20120111 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 62011-0092_4d608e1b-207e-4353-933b-945f36137374 62011-0092 HUMAN OTC DRUG health mart adult tussin Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20120111 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 62011-0093_7347f8b3-c133-4236-b9b5-ddbb7fc617cd 62011-0093 HUMAN OTC DRUG Childrens Cetirizine Hydrochloride Cetirizine hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Health Mart CETIRIZINE HYDROCHLORIDE 1 mg/mL 62011-0094_3dce7e40-187d-4a9f-a977-b4e4e548714d 62011-0094 HUMAN OTC DRUG Health Mart Pharmacy Bacitracin Zinc First Aid Antibiotic bacitracin zinc OINTMENT TOPICAL 19901205 OTC MONOGRAPH FINAL part333B Health Mart BACITRACIN ZINC 500 [USP'U]/g 62011-0095_b7914043-9983-4c18-83d3-6bf9637c0940 62011-0095 HUMAN OTC DRUG Health Mart Pharmacy Hydrocortisone Maximum Strength with Aloe hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Health Mart HYDROCORTISONE 1 g/100g 62011-0096_97ac5ca4-8a66-4363-8300-c9d41dbb4a74 62011-0096 HUMAN OTC DRUG Health Mart Pharmacy Hydrocortisone Maximum Strength Plus 12 Moisturizers hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Health Mart HYDROCORTISONE 1 g/100g 62011-0097_60b89345-c6d6-4d74-ada0-1050d8912fd6 62011-0097 HUMAN OTC DRUG Double Antibiotic Bacitracin Zinc and Polymyxin B Sulfate OINTMENT TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Health Mart BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g 62011-0098_41b9963f-3c3c-4315-b985-9334be186e2f 62011-0098 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Health Mart BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 62011-0099_5939be35-58bd-4f1c-84e8-5b131072290a 62011-0099 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20120312 OTC MONOGRAPH FINAL part333B Health Mart BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 62011-0100_c32a5199-2b3c-45c3-83d1-0dae63b240d8 62011-0100 HUMAN OTC DRUG Eye Drops Redness and Dry Eye Relief Naphazoline hydrochloride, Glycerin SOLUTION/ DROPS OPHTHALMIC 20120301 OTC MONOGRAPH FINAL part349 McKesson GLYCERIN; NAPHAZOLINE HYDROCHLORIDE 2; .12 mg/mL; mg/mL 62011-0101_27f326c7-e818-4e6b-9bfb-cf1d423909c9 62011-0101 HUMAN OTC DRUG Artificial Tears Polyvinyl alcohol, Povidone SOLUTION/ DROPS OPHTHALMIC 20120301 OTC MONOGRAPH FINAL part349 McKesson POLYVINYL ALCOHOL; POVIDONE 5; 6 mg/mL; mg/mL 62011-0102_cd528b3c-d746-47ab-8c39-b4cb9fd2ea4e 62011-0102 HUMAN OTC DRUG Eye Drops Regular Tetrahydrozoline hydrochloride SOLUTION/ DROPS OPHTHALMIC 20120301 OTC MONOGRAPH FINAL part349 McKesson TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 62011-0104_c1b667f2-71b2-460f-b643-38423b80dfc5 62011-0104 HUMAN OTC DRUG Eye Drops Advanced Relief Tetrahydrozoline hydrochloride, Polyethylene glycol 400, Dextran 70, Povidone SOLUTION/ DROPS OPHTHALMIC 20120301 OTC MONOGRAPH FINAL part349 McKesson DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL 62011-0105_345bfecc-cbf3-4401-a9b2-d0ba274cd35c 62011-0105 HUMAN OTC DRUG Health Mart eye itch relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20120203 ANDA ANDA077958 McKesson KETOTIFEN FUMARATE .25 mg/mL 62011-0107_9deeddc3-0247-4686-a782-fc11bc987ada 62011-0107 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70 percent Isopropyl Alcohol LIQUID TOPICAL 20141130 OTC MONOGRAPH NOT FINAL part333A McKesson (Health Mart) ISOPROPYL ALCOHOL 70 mL/100mL 62011-0108_601d2d1d-64db-4388-99c9-27f1ddf9a5b6 62011-0108 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A McKesson (Health Mart) ISOPROPYL ALCOHOL 91 mL/100mL 62011-0111_3d187bc0-7783-4062-8541-6fdcf13c850b 62011-0111 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20141130 OTC MONOGRAPH NOT FINAL part356 McKesson (Health Mart) HYDROGEN PEROXIDE 2.65 mL/100mL 62011-0112_1f6b419d-7178-4d78-9005-4847c7d8b44f 62011-0112 HUMAN OTC DRUG Lice Treatment permethrin LOTION TOPICAL 20120601 ANDA ANDA075014 McKesson PERMETHRIN 1 mg/100mL 62011-0114_a014fd3a-7013-4053-b479-f98aefc65699 62011-0114 HUMAN OTC DRUG Health Mart Calamine Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 McKesson ZINC OXIDE 160 mg/mL 62011-0117_218cc213-04af-49da-97a8-4c6a79fa6f75 62011-0117 HUMAN OTC DRUG Health Mart Iodine Tincture Mild Iodine and Sodium Iodide and Alcohol LIQUID TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A McKesson ALCOHOL; IODINE; SODIUM IODIDE 470; 20; 20.4 mg/mL; mg/mL; mg/mL 62011-0118_26bf0d3a-c367-4c93-9186-1fba163661a0 62011-0118 HUMAN OTC DRUG Humco Povidone Iodine Povidone Iodine 10% LIQUID TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A McKesson POVIDONE-IODINE 100 mg/mL 62011-0119_e0bdebe2-46d3-41e1-86d8-43c366ed6959 62011-0119 HUMAN OTC DRUG health mart lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20120228 OTC MONOGRAPH FINAL part358G McKesson PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL 62011-0120_efd2f798-e11c-405d-b48c-603d55523547 62011-0120 HUMAN OTC DRUG health mart allergy and congestion Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120306 ANDA ANDA076050 McKesson LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 62011-0122_04cd1e2e-5308-38c0-e054-00144ff8d46c 62011-0122 HUMAN OTC DRUG ADVANCED ANTACID CHERRY aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 20120601 OTC MONOGRAPH FINAL part331 McKesson ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 62011-0123_04ded39a-e6dd-59b8-e054-00144ff8d46c 62011-0123 HUMAN OTC DRUG MILK OF MAGNESIA MINT magnesium hydroxide LIQUID ORAL 20120401 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM HYDROXIDE 1200 mg/15mL 62011-0124_04eadf40-b664-3666-e054-00144ff8d46c 62011-0124 HUMAN OTC DRUG MILK OF MAGNESIA ORIGINAL magnesium hydroxide LIQUID ORAL 20120401 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM HYDROXIDE 1200 mg/15mL 62011-0131_a98908ec-013f-4107-bf72-657788251fb6 62011-0131 HUMAN OTC DRUG Health Mart Calcium antacid Assorted Fruit Calcium carbonate TABLET, CHEWABLE ORAL 20120401 OTC MONOGRAPH FINAL part331 Health Mart CALCIUM CARBONATE 750 mg/1 62011-0132_d0d791f0-b820-4253-a2df-7a7c9b1f9efb 62011-0132 HUMAN OTC DRUG Health Mart calcium antacid calcium carbonate TABLET, CHEWABLE ORAL 20120401 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 500 mg/1 62011-0133_bbbe05ef-dbee-4bff-b5a4-dcacd1d49ed1 62011-0133 HUMAN OTC DRUG Smooth texture Orange flavor psyllium husk POWDER, FOR SUSPENSION ORAL 20120421 OTC MONOGRAPH NOT FINAL part334 HEALTH MART PSYLLIUM HUSK 3.4 g/12g 62011-0134_a38a07d4-0791-4ed9-9446-663673191469 62011-0134 HUMAN OTC DRUG Health Mart fiber caplets Methylcellulose TABLET ORAL 20120423 OTC MONOGRAPH FINAL part334 McKesson METHYLCELLULOSE (4000 CPS) 500 mg/1 62011-0135_1a38c9a6-7035-4a4a-857b-a5436cf026fd 62011-0135 HUMAN OTC DRUG Original texture Orange flavor psyllium husk POWDER, FOR SUSPENSION ORAL 20120421 OTC MONOGRAPH NOT FINAL part334 HEALTH MART PSYLLIUM HUSK 3.4 g/11g 62011-0136_0259721d-64bc-4d51-a8a7-3830e60c8824 62011-0136 HUMAN OTC DRUG Bulk-forming Laxative psyllium husk POWDER, FOR SUSPENSION ORAL 20120419 OTC MONOGRAPH NOT FINAL part334 HEALTH MART PSYLLIUM HUSK 3.4 g/7g 62011-0137_4a145697-965e-4a46-81cc-b99535f3c132 62011-0137 HUMAN OTC DRUG Health Mart fiber psyllium husk POWDER, FOR SUSPENSION ORAL 20120412 OTC MONOGRAPH NOT FINAL part334 Health Mart PSYLLIUM HUSK 3.4 g/5.8g 62011-0138_4273514d-2706-4fdb-a2ca-67905b876673 62011-0138 HUMAN OTC DRUG Health Mart gas relief simethicone TABLET, CHEWABLE ORAL 20120401 OTC MONOGRAPH FINAL part332 Mckesson DIMETHICONE 80 mg/1 62011-0139_49b0d299-ee12-4a01-aa96-ae707eb70062 62011-0139 HUMAN OTC DRUG Health Mart Simethicone Simethicone EMULSION ORAL 20120401 OTC MONOGRAPH FINAL part332 McKesson DIMETHICONE 20 mg/.3mL 62011-0140_3287befc-65ab-4978-bc0e-687da3f8cb23 62011-0140 HUMAN OTC DRUG Health Mart Stomach relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20120401 OTC MONOGRAPH FINAL part335 McKesson BISMUTH SUBSALICYLATE 262 mg/1 62011-0141_9ca61e18-040e-429b-a8cd-3443efd55235 62011-0141 HUMAN OTC DRUG Health Mart Castor Oil Castor Oil LIQUID ORAL 20080101 OTC MONOGRAPH NOT FINAL part334 McKesson CASTOR OIL 1 mg/mL 62011-0142_ada32eac-40de-4d86-af2a-16becdbf1bf2 62011-0142 HUMAN OTC DRUG health mart famotidine Famotidine TABLET ORAL 20120320 ANDA ANDA075400 McKesson FAMOTIDINE 10 mg/1 62011-0143_4918a39c-856f-474e-bb0f-c837d1c4005b 62011-0143 HUMAN OTC DRUG Health Mart Famotidine Famotidine TABLET ORAL 20120320 ANDA ANDA077351 McKesson FAMOTIDINE 20 mg/1 62011-0144_0d6af1bf-1d0c-4369-95bf-dc257eb1ed39 62011-0144 HUMAN OTC DRUG health mart acid reducer Ranitidine TABLET ORAL 20120320 ANDA ANDA076760 McKesson RANITIDINE HYDROCHLORIDE 75 mg/1 62011-0145_b47a08cb-3f91-4c39-86ca-1b68aa167801 62011-0145 HUMAN OTC DRUG health mart acid reducer Ranitidine TABLET ORAL 20120320 ANDA ANDA078653 McKesson RANITIDINE HYDROCHLORIDE 150 mg/1 62011-0147_2b60399c-2836-4009-a62c-ddb194b32d08 62011-0147 HUMAN OTC DRUG health mart antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20120320 OTC MONOGRAPH FINAL part332 McKesson ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 62011-0148_af735564-36d7-4281-957e-057a62b4070b 62011-0148 HUMAN OTC DRUG health mart antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20120320 OTC MONOGRAPH FINAL part332 McKesson ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 62011-0149_04cd1e2e-5320-38c0-e054-00144ff8d46c 62011-0149 HUMAN OTC DRUG MAXIMUM STRENGTH ANTACID aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20120401 OTC MONOGRAPH FINAL part331 McKesson ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 62011-0150_436db35b-1363-428d-986f-e63ce139344f 62011-0150 HUMAN OTC DRUG health mart anti diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20120320 ANDA ANDA075232 McKesson LOPERAMIDE HYDROCHLORIDE 2 mg/1 62011-0151_5ffac51a-1caa-4568-a2f9-acf2922a5804 62011-0151 HUMAN OTC DRUG health mart loperamide hydrochloride loperamide HCl LIQUID ORAL 20120320 ANDA ANDA091292 McKesson LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 62011-0152_4d9504e2-8991-4705-abb5-5320e4513da7 62011-0152 HUMAN OTC DRUG Health Mart anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 20120320 UNAPPROVED DRUG OTHER McKesson DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL 62011-0153_43d2d04c-eb59-43a2-9c89-4f9accaac5f2 62011-0153 HUMAN OTC DRUG health mart clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20120320 ANDA ANDA090685 McKesson POLYETHYLENE GLYCOL 3350 17 g/17g 62011-0154_46479cf1-5d61-4a55-991c-f4cb2fefc1d3 62011-0154 HUMAN OTC DRUG health mart enema Dibasic sodium phosphate, Monobasic sodium phosphate ENEMA RECTAL 20120320 OTC MONOGRAPH NOT FINAL part334 McKesson SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 62011-0156_ca5380be-10d5-4b17-b668-f4a9a03e8542 62011-0156 HUMAN OTC DRUG health mart enema Mineral Oil LIQUID RECTAL 20120510 OTC MONOGRAPH NOT FINAL part334 Mckesson MINERAL OIL 100 mL/100mL 62011-0157_eb2b2436-60df-4f48-b3fe-ad872c383e59 62011-0157 HUMAN OTC DRUG health mart omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20120320 NDA NDA022032 McKesson OMEPRAZOLE 20 mg/1 62011-0158_cd2e5be5-0067-4149-98a8-a889ad2ab0f7 62011-0158 HUMAN OTC DRUG Loperamide HCl LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20120625 NDA NDA021855 McKesson LOPERAMIDE HYDROCHLORIDE 2 mg/1 62011-0159_a9cf8b58-2b55-466d-8210-fc878252c4ef 62011-0159 HUMAN OTC DRUG Laxative BISACODYL TABLET, COATED ORAL 20120627 OTC MONOGRAPH NOT FINAL part334 McKesson (Health Mart) BISACODYL 5 mg/1 62011-0160_254b70df-bb4f-4922-b947-e38e16f70b47 62011-0160 HUMAN OTC DRUG Health Mart Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20120605 OTC MONOGRAPH FINAL part347 McKesson (Health Mart) DIMETHICONE 125 mg/1 62011-0161_2946579c-1b53-4a57-b39b-80645d5bd012 62011-0161 HUMAN OTC DRUG Senna-S DOCUSATE SODIUM, SENNOSIDES TABLET, COATED ORAL 20120518 OTC MONOGRAPH NOT FINAL part334 McKesson DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 62011-0162_b86fb8bf-952f-40a2-a5ae-319fb30d0355 62011-0162 HUMAN OTC DRUG Senna Sennosides TABLET ORAL 20120518 OTC MONOGRAPH FINAL part334 McKesson SENNOSIDES A AND B 8.6 mg/1 62011-0163_e6291a91-9efc-4bca-9262-22c60686a5a4 62011-0163 HUMAN OTC DRUG Health Mart Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120518 OTC MONOGRAPH NOT FINAL part334 McKesson DOCUSATE SODIUM 100 mg/1 62011-0165_9a1ecb37-ee12-44d6-9551-699812070a06 62011-0165 HUMAN OTC DRUG Stool Softener with Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20120518 OTC MONOGRAPH NOT FINAL part334 McKesson DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 62011-0166_4acce568-dddb-4c8c-b95a-9b1f95048c0c 62011-0166 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20120320 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM CITRATE 1.745 g/29.6mL 62011-0167_4635a059-1d0d-4f98-b6ff-272ecb6d4f2d 62011-0167 HUMAN OTC DRUG Earwax Removal Aid Earwax Removal Aid LIQUID AURICULAR (OTIC) 20120206 OTC MONOGRAPH FINAL part344 McKesson CARBAMIDE PEROXIDE 6.5 mg/100mL 62011-0168_ae0a1481-0b4d-4c82-bda7-55d4331e0bd3 62011-0168 HUMAN OTC DRUG health mart lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120521 ANDA ANDA202319 McKesson LANSOPRAZOLE 15 mg/1 62011-0169_9144cd5d-32fc-46c9-ab5d-ad364894d321 62011-0169 HUMAN OTC DRUG Earwax Removal Kit Earwax Removal Kit LIQUID AURICULAR (OTIC) 20120206 OTC MONOGRAPH FINAL part344 McKesson CARBAMIDE PEROXIDE 6.5 mg/100mL 62011-0170_d8dce57f-599b-4b1d-8ac1-15b9102cad25 62011-0170 HUMAN OTC DRUG health mart nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20140402 ANDA ANDA078326 McKesson NICOTINE 4 mg/1 62011-0171_fed961b6-d6ee-46ae-aa61-c0a7a31b7958 62011-0171 HUMAN OTC DRUG health mart nicotine Nicotine Polacrilex LOZENGE ORAL 20111121 ANDA ANDA077007 McKesson NICOTINE 4 mg/1 62011-0172_af3c3a4d-37f4-41cb-bb17-2823397c4120 62011-0172 HUMAN OTC DRUG HEALTHMART NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 McKesson NICOTINE 14 mg/24h 62011-0173_af3c3a4d-37f4-41cb-bb17-2823397c4120 62011-0173 HUMAN OTC DRUG HEALTHMART NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 McKesson NICOTINE 21 mg/24h 62011-0174_09f61772-4d0e-474b-9fd6-4b629d7377f0 62011-0174 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20120320 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM CITRATE 1.745 g/29.6mL 62011-0175_af4c1d98-00ef-41e5-8c33-db74bdd0cb1c 62011-0175 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20141130 OTC MONOGRAPH FINAL part347 McKesson (Health Mart) WITCH HAZEL 842 mg/mL 62011-0176_977738e3-6c8a-4062-a465-4058a343d3da 62011-0176 HUMAN OTC DRUG Health Mart Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120828 ANDA ANDA091135 McKesson DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 62011-0180_6e2f4ef2-5a3d-40a9-a4a6-e9c671970f97 62011-0180 HUMAN OTC DRUG HealthMart Childrens Cetirizine Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 McKesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL 62011-0181_b20bded9-6686-44fc-b797-16ab3b01ecdb 62011-0181 HUMAN OTC DRUG HealthMart Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 McKesson LORATADINE 5 mg/5mL 62011-0182_db610bb7-f8a0-4d3c-9676-4f812d34fb4b 62011-0182 HUMAN OTC DRUG Health Mart Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20130105 ANDA ANDA077355 McKesson CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 62011-0183_d02750b1-1709-4fc4-9c5e-118c200dfc28 62011-0183 HUMAN OTC DRUG Health Mart Childrens Pain and Fever Acetaminophen LIQUID ORAL 20130117 OTC MONOGRAPH NOT FINAL part343 Mckesson ACETAMINOPHEN 160 mg/5mL 62011-0185_a0db4f50-63f8-4d50-8a2b-3f5f27705500 62011-0185 HUMAN OTC DRUG health mart migraine formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20130129 ANDA ANDA075794 McKesson ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 62011-0186_16f425a1-3b7e-4de7-b049-0ddeee559778 62011-0186 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20121019 OTC MONOGRAPH FINAL part338 Mckesson (Health Mart) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 62011-0187_edbaabec-6739-4314-baa8-b7dfe20f6c3a 62011-0187 HUMAN OTC DRUG infants gas relief drops simethicone EMULSION ORAL 20121101 OTC MONOGRAPH FINAL part332 Health Mart DIMETHICONE 20 mg/.3mL 62011-0188_f30b1e59-21d4-4ec3-a91b-e772c1fa5ce2 62011-0188 HUMAN OTC DRUG Stool Softener with Laxative Docusate sodium and Sennosides TABLET ORAL 20120410 OTC MONOGRAPH NOT FINAL part334 Mckesson (Health Mart) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 62011-0189_28f05cb2-91b0-4111-a443-b5999ca1e9d4 62011-0189 HUMAN OTC DRUG gas relief simethicone TABLET, CHEWABLE ORAL 20121001 OTC MONOGRAPH FINAL part332 Health Mart DIMETHICONE 125 mg/1 62011-0190_61f4eb7d-b61b-4c69-8350-19977def7b50 62011-0190 HUMAN OTC DRUG HealthMart Pharmacy Lubricant Laxative mineral oil ENEMA RECTAL 20140127 OTC MONOGRAPH NOT FINAL part334 McKesson MINERAL OIL 118 mL/118mL 62011-0191_516825ce-c642-4d71-9669-006bba9ade82 62011-0191 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20130822 OTC MONOGRAPH NOT FINAL part334 McKesson SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 62011-0192_6f7c1283-b6d1-456f-98a4-87305d798294 62011-0192 HUMAN OTC DRUG Senna Natural vegetable laxative SENNOSIDES TABLET ORAL 20120315 OTC MONOGRAPH NOT FINAL part334 McKesson (Health Mart) SENNOSIDES 8.6 mg/1 62011-0193_c98a0d1f-c973-4629-aa81-aa107170e28b 62011-0193 HUMAN OTC DRUG adult cold, flu and sore throat acteaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 1/20mL; mg/20mL; mg/20mL; mg/20mL 62011-0194_65e99d86-bcd6-43c4-928b-c113597c97df 62011-0194 HUMAN OTC DRUG adult severe congestion and cough Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Health Mart DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL 62011-0195_75cab1ba-72f4-47b9-ae9e-c1778d974ddc 62011-0195 HUMAN OTC DRUG Childrens mucus relief multi-symptom cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Health Mart DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 62011-0197_c0501f39-cf86-46db-b8ae-046b1d7e2b6f 62011-0197 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130430 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 62011-0198_ca2115d8-3bb5-4374-a21f-f3a1e7c416cd 62011-0198 HUMAN OTC DRUG Health Mart Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130618 ANDA ANDA091135 McKesson DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 62011-0199_66f3a223-2cf8-4016-8142-522615120077 62011-0199 HUMAN OTC DRUG Health Mart nicotine polacrilex Nicotine Polacrilex LOZENGE ORAL 20130610 ANDA ANDA203690 McKesson NICOTINE 2 mg/1 62011-0200_80131b35-5ce0-4116-845c-95bd70512be0 62011-0200 HUMAN OTC DRUG Health Mart Nicotine Nicotine Polacrilex LOZENGE ORAL 20130702 ANDA ANDA203690 Mckesson NICOTINE 4 mg/1 62011-0201_5964809b-6a9f-452e-a4f7-e732ab37a3a8 62011-0201 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130331 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 62011-0203_171fda0c-c4b4-443c-a784-72f5a831eab3 62011-0203 HUMAN OTC DRUG Health Mart Lubricating Plus carboxymethylcellulose sodium SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130610 OTC MONOGRAPH FINAL part349 Mckesson CARBOXYMETHYLCELLULOSE SODIUM .5 g/100mL 62011-0204_20932ad4-6c1c-4b44-94fe-60b9c4ab0a93 62011-0204 HUMAN OTC DRUG Health Mart Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130815 ANDA ANDA076518 McKesson NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 62011-0205_628cf975-5d38-4012-b1a8-799829ae78c4 62011-0205 HUMAN OTC DRUG All Day Allergy 24 hour Cetirizine HCl TABLET ORAL 20120101 ANDA ANDA078780 McKesson (Health Mart) CETIRIZINE HYDROCHLORIDE 10 mg/1 62011-0209_76d21f83-1ccc-437b-a1c7-a10c0623d1b8 62011-0209 HUMAN OTC DRUG Health Mart Muscle Rub Menthol, Methyl salicylate CREAM TOPICAL 20131014 OTC MONOGRAPH NOT FINAL part348 McKesson MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g 62011-0210_4ffa42cb-6c10-48a3-affd-0e30dbc8e14d 62011-0210 HUMAN OTC DRUG Health Mart Z Sleep Diphenhydramine HCl SOLUTION ORAL 20130716 OTC MONOGRAPH FINAL part338 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL 62011-0211_de7723af-7ab2-4d96-9fa0-edda8d6a1796 62011-0211 HUMAN OTC DRUG Health Mart Adult Tussin DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20130813 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL 62011-0212_c75c3cac-a160-4402-885d-31c61fe42ea2 62011-0212 HUMAN OTC DRUG Health Mart Aspirin Aspirin TABLET, CHEWABLE ORAL 20130813 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 62011-0213_c36847c0-4741-4178-8a1a-697c068591fd 62011-0213 HUMAN OTC DRUG Health Mart Ibuprofen IB Ibuprofen TABLET, FILM COATED ORAL 20131026 ANDA ANDA077349 McKesson IBUPROFEN 200 mg/1 62011-0214_1d81eea7-0104-4b3d-842c-c763e290581c 62011-0214 HUMAN OTC DRUG Health Mart Childrens Ibuprofen Ibuprofen LIQUID ORAL 20130813 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL 62011-0215_25e0c50a-061b-43c4-9000-6a9bb673ad0d 62011-0215 HUMAN OTC DRUG Health Mart Nighttime Sleep Aid Diphenhydramine Hydrochloride TABLET ORAL 20130813 OTC MONOGRAPH FINAL part338 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 62011-0217_1cc4b5c6-3a4a-4260-af6f-6ab8d5a5a1eb 62011-0217 HUMAN OTC DRUG HealthMart Mucus Relief FM Acetaminophen, guaifenesin, Phenylephrine HCl TABLET ORAL 20130404 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 62011-0218_3bcc776a-f2ec-4032-b2b6-a689dd247b15 62011-0218 HUMAN OTC DRUG HealthMart Mucus Relief FM Acetaminophen, dextromethorphan HBr, guaifenesin, Phenylephrine HCl TABLET ORAL 20130404 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 62011-0219_6012d1e9-1ba6-42a7-91dd-9e85ab76a01c 62011-0219 HUMAN OTC DRUG HealthMart Mucus Relief FM Acetaminophen, dextromethorphan HBr, guaifenesin, Phenylephrine HCl TABLET ORAL 20130404 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 62011-0221_7b43b1c6-8915-4086-879e-3b45f746806c 62011-0221 HUMAN OTC DRUG Health Mart z-sleep Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140131 OTC MONOGRAPH FINAL part338 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 62011-0222_ed8e32e4-b9ec-456d-8666-6ffcb7bc012e 62011-0222 HUMAN OTC DRUG Health Mart Ibuprofen IB Ibuprofen TABLET, COATED ORAL 20111121 ANDA ANDA077349 McKesson IBUPROFEN 200 mg/1 62011-0223_f607ed60-c112-4d73-b89b-61b63e2206fa 62011-0223 HUMAN OTC DRUG health mart acid reducer Ranitidine TABLET, FILM COATED ORAL 20120320 ANDA ANDA091429 Mckesson RANITIDINE HYDROCHLORIDE 150 mg/1 62011-0224_a04e97cf-6095-4e67-97eb-b8bdba463943 62011-0224 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130813 OTC MONOGRAPH NOT FINAL part334 McKesson (Health Mart) DOCUSATE SODIUM 100 mg/1 62011-0225_210820c3-6696-458a-ab49-6933aa23a9f2 62011-0225 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130920 ANDA ANDA201745 Health Mart RANITIDINE HYDROCHLORIDE 75 mg/1 62011-0226_34264bbd-6459-48a0-9a89-56cb78b88783 62011-0226 HUMAN OTC DRUG Nighttime Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 62011-0227_c706df7c-3483-4f12-ac87-2e7fe39bf5e8 62011-0227 HUMAN OTC DRUG acid reducer Ranitidine TABLET ORAL 20140107 ANDA ANDA200536 McKesson RANITIDINE HYDROCHLORIDE 150 mg/1 62011-0228_0bd2dcf6-3289-4321-903f-b80526ea8803 62011-0228 HUMAN OTC DRUG Helath Mart Childrens allergy relief dye free Diphenhydramine HCl LIQUID ORAL 20140909 OTC MONOGRAPH FINAL part341 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 62011-0229_917d30f4-0427-4987-8e01-a94e0a0814e5 62011-0229 HUMAN OTC DRUG Healthmart Calcium Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20130808 OTC MONOGRAPH FINAL part331 Mckesson CALCIUM CARBONATE 750 mg/1 62011-0230_60f34c08-baad-4cf2-930a-9ce252d5a5df 62011-0230 HUMAN OTC DRUG Health Mart Junior Rapid Melts Acetaminophen TABLET, CHEWABLE ORAL 20130801 OTC MONOGRAPH NOT FINAL part343 Mckesson ACETAMINOPHEN 160 mg/1 62011-0231_dae14eb1-1075-4437-b6b3-e63f013e3e45 62011-0231 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131202 OTC MONOGRAPH FINAL part347 McKesson (Health Mart) DIMETHICONE 125 mg/1 62011-0232_ab5e1a1a-15f8-454c-8226-f9e5eb71aeb9 62011-0232 HUMAN OTC DRUG eye itch relief ketotifen fumarate SOLUTION/ DROPS OPHTHALMIC 20140207 ANDA ANDA077958 McKesson Corp. KETOTIFEN FUMARATE .35 mg/mL 62011-0233_feb83f81-32b9-46f3-8407-9a23ea787f75 62011-0233 HUMAN OTC DRUG health mart fexofenadine hydrochloride fexofenadine hcl TABLET, FILM COATED ORAL 20140401 ANDA ANDA076447 McKesson FEXOFENADINE HYDROCHLORIDE 180 mg/1 62011-0236_629987c1-abf3-4149-afba-f306c55e44ad 62011-0236 HUMAN OTC DRUG Health Mart Loperamide Hydrochloride Loperamide Hydrochloride SUSPENSION ORAL 20140611 ANDA ANDA091292 McKesson LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 62011-0238_062dd7dd-a043-58a1-e054-00144ff8d46c 62011-0238 HUMAN OTC DRUG Pain Reliever Rapid Release Acetaminophen TABLET, COATED ORAL 20141024 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 62011-0239_7736eaa4-a8d7-4528-ab53-b282b017142b 62011-0239 HUMAN OTC DRUG Health Mart Daytime acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140610 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 62011-0240_066b8682-1a30-48ea-e054-00144ff8d46c 62011-0240 HUMAN OTC DRUG Severe Sinus Congestion and Pain ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141027 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 62011-0241_066b8682-1a44-48ea-e054-00144ff8d46c 62011-0241 HUMAN OTC DRUG Severe Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141027 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 62011-0243_9d2395eb-24f9-4b92-b352-6bbf810fdbfc 62011-0243 HUMAN OTC DRUG health mart migraine relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20140422 ANDA ANDA075794 McKesson ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 62011-0244_b517b975-7db3-4598-963e-908282590ce7 62011-0244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140530 OTC MONOGRAPH NOT FINAL part334 McKesson (Health Mart) DOCUSATE SODIUM 250 mg/1 62011-0245_6fe619e3-6409-4cfe-9f29-a40d4a749f27 62011-0245 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140731 OTC MONOGRAPH NOT FINAL part356 McKesson (Health Mart) PHENOL 1.4 g/100mL 62011-0246_977bebaa-1fdf-40b0-ab37-7d594968e6c2 62011-0246 HUMAN OTC DRUG health mart childrens pain and fever Acetaminophen SUSPENSION ORAL 20140919 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL 62011-0247_b56edf36-899d-4686-a133-5935f9c06e6b 62011-0247 HUMAN OTC DRUG health mart pain and fever childrens Acetaminophen SUSPENSION ORAL 20140904 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL 62011-0248_69664ec4-ce52-4dd5-a9f5-56dd0a8e6ef5 62011-0248 HUMAN OTC DRUG health mart loratadine Loratadine TABLET ORAL 20141002 ANDA ANDA076301 McKesson LORATADINE 10 mg/1 62011-0249_d70c0abd-844f-4dc2-8d2e-f5a8ef53ec05 62011-0249 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141031 NDA NDA021920 McKesson (Health Mart) NAPROXEN SODIUM 220 mg/1 62011-0500_3d5106a3-f191-4e2e-a0f7-41adbc1aa57b 62011-0500 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 McKesson SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 62011-0552_1298bb1d-6fdb-48bb-86eb-b51f19dbe6fb 62011-0552 HUMAN OTC DRUG All Day Allergy Cetirizine HCl TABLET ORAL 20120208 ANDA ANDA078780 McKesson (Health Mart) CETIRIZINE HYDROCHLORIDE 10 mg/1 62018-001_f2da3bf8-e597-443e-9439-631920c46477 62018-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Respiratory Home Care Specialists, Inc. OXYGEN 99 L/100L 62032-070_0960cb9d-413e-4eeb-83b8-135b75642f90 62032-070 HUMAN OTC DRUG NU-DERM PHYSICAL UV BROAD SPECTRUM SPF 32 ZINC OXIDE LOTION TOPICAL 20040101 OTC MONOGRAPH FINAL part352 OMP, Inc. ZINC OXIDE 185 mg/g 62032-072_affadfae-ce06-42b6-a044-ee621d6ea727 62032-072 HUMAN OTC DRUG ROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30 SUNCREEN TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20090101 OTC MONOGRAPH FINAL part352 OMP, Inc. TITANIUM DIOXIDE; ZINC OXIDE 20; 155 mg/mL; mg/mL 62032-100_5340a775-399e-4233-a30d-e4e872023d3f 62032-100 HUMAN PRESCRIPTION DRUG NU-DERM BLENDER Skin Lightener and Blending HYDROQUINONE CREAM TOPICAL 19880101 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 62032-101_5340a775-399e-4233-a30d-e4e872023d3f 62032-101 HUMAN PRESCRIPTION DRUG NU-DERM CLEAR Skin Bleaching and Corrector HYDROQUINONE CREAM TOPICAL 19880101 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 62032-102_4eac9f57-6759-444e-9182-d01ff3f52155 62032-102 HUMAN OTC DRUG NU-DERM PHYSICAL UV BLOCK SPF 32 ZINC OXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH FINAL part352 OMP, Inc. ZINC OXIDE 185 mg/g 62032-103_f05364b7-1473-4cf3-81d7-3e2b031d545e 62032-103 HUMAN OTC DRUG ROSACLEAR SKIN BALANCING SUN PROTECTION SPF 30 SUNCREEN TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20090101 OTC MONOGRAPH FINAL part352 OMP, Inc. TITANIUM DIOXIDE; ZINC OXIDE 20; 155 mg/mL; mg/mL 62032-104_c9ef85c0-cdaa-43ff-8ea3-803e30fb1bb4 62032-104 HUMAN OTC DRUG NU-DERM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN OCTINOXATE and ZINC OXIDE LOTION TOPICAL 20121107 OTC MONOGRAPH FINAL part352 OMP, Inc. OCTINOXATE; ZINC OXIDE 75; 105 mg/g; mg/g 62032-105_8bee994d-058d-4615-b3ae-eff9d4eccdd9 62032-105 HUMAN PRESCRIPTION DRUG OBAGI-C RX SYSTEM C-THERAPY Skin Lightening with Vitamins C and E HYDROQUINONE CREAM TOPICAL 20100101 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 62032-106_c6ecb5cc-fd60-4e19-8e65-4eddbf21fc42 62032-106 HUMAN PRESCRIPTION DRUG OBAGI C RX SYSTEM C CLARIFYING SERUM HYDROQUINONE SOLUTION TOPICAL 20100101 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE 40 mg/mL Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 62032-107_9d299169-a814-4269-84ab-aa951c479e28 62032-107 HUMAN OTC DRUG OBAGI-C RX SYSTEM C-SUNGUARD SPF 30 OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20020101 OTC MONOGRAPH FINAL part352 OMP, Inc. OCTINOXATE; ZINC OXIDE 75; 90 mg/mL; mg/mL 62032-108_6c4ef21b-f06a-4a19-b667-5bea96e12ada 62032-108 HUMAN OTC DRUG OBAGI-C RX SYSTEM C-EXFOLIATING DAY with Vitamin C OCTISALATE, OCTINOXATE, and OXYBENZONE LOTION TOPICAL 20040101 OTC MONOGRAPH FINAL part352 OMP, INC. OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 40 mg/mL; mg/mL; mg/mL 62032-110_1d93c707-3b66-4904-bc9c-deda90d26ab8 62032-110 HUMAN OTC DRUG CLENZIDERM PORE THERAPY ACNE TREATMENT SALICYLIC ACID LIQUID TOPICAL 20070201 OTC MONOGRAPH FINAL part333D OMP, INC. SALICYLIC ACID 20 mg/mL 62032-111_209d04e7-f03e-4697-9a04-f0d7026bdba0 62032-111 HUMAN OTC DRUG CLENZIDERM DAILY CARE FOAMING CLEANSER ACNE TREATMENT SALICYLIC ACID LIQUID TOPICAL 20070201 OTC MONOGRAPH FINAL part333D OMP, INC. SALICYLIC ACID 20 mg/mL 62032-112_6e04ac42-958e-4163-a585-c9f9212801f6 62032-112 HUMAN OTC DRUG NU-DERM Tolereen Anti-pruritic Hydrocortisone LOTION TOPICAL 19880101 OTC MONOGRAPH NOT FINAL part348 OMP, Inc. HYDROCORTISONE 5 mg/g 62032-113_93b5a3fe-6f00-49bc-be4e-cc4847be1eb4 62032-113 HUMAN OTC DRUG CLENZIDERM THERAPEUTIC BENZOYL PEROXIDE LOTION TOPICAL 20070701 OTC MONOGRAPH FINAL part333D OMP, INC. BENZOYL PEROXIDE 50 mg/mL 62032-114_8ab78b75-5922-46ea-98ed-15a8813760f5 62032-114 HUMAN OTC DRUG CLENZIDERM THERAPEUTIC MOISTURIZER GLYCERIN CREAM TOPICAL 20070701 OTC MONOGRAPH FINAL part347 OMP, INC. GLYCERIN 200 mg/mL 62032-115_177c26ac-3552-4d11-816d-717a5752a16c 62032-115 HUMAN PRESCRIPTION DRUG CONDITION AND ENHANCE BLENDER Skin Lightener and Blending HYDROQUINONE CREAM TOPICAL 19880101 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 62032-116_5340a775-399e-4233-a30d-e4e872023d3f 62032-116 HUMAN PRESCRIPTION DRUG NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE HYDROQUINONE, OCTINOXATE, and OXYBENZONE LOTION TOPICAL 19840101 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE; OCTINOXATE; OXYBENZONE 40; 75; 55 mg/g; mg/g; mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 62032-117_177c26ac-3552-4d11-816d-717a5752a16c 62032-117 HUMAN PRESCRIPTION DRUG CONDITION AND ENHANCE CLEAR Skin Bleaching and Corrector HYDROQUINONE CREAM TOPICAL 19880101 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 62032-118_be81dac4-75d9-4625-b1f1-c84473ce995b 62032-118 HUMAN OTC DRUG CONDITION AND ENHANCE PHYSICAL UV BLOCK SPF 32 ZINC OXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH FINAL part352 OMP, Inc. ZINC OXIDE 185 mg/g 62032-119_d849a01a-d751-4bd9-b02a-082968689a93 62032-119 HUMAN OTC DRUG CONDITION AND ENHANCE HEALTHY SKIN PROTECTION SPF 35 OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20020101 OTC MONOGRAPH FINAL part352 OMP, Inc. OCTINOXATE; ZINC OXIDE 75; 90 mg/mL; mg/mL 62032-120_278051da-6898-4975-9573-261ef688a2f7 62032-120 HUMAN PRESCRIPTION DRUG ELASTIDERM DECOLLETAGE SKIN LIGHTENING COMPLEX Chest and Neck HYDROQUINONE LOTION TOPICAL 20101201 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 62032-121_c49b3eed-0822-42fb-8ec9-6dfb2715fb31 62032-121 HUMAN OTC DRUG OBAGI-C RX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN OCTINOXATE and ZINC OXIDE LOTION TOPICAL 20121107 OTC MONOGRAPH FINAL part352 OMP, Inc. OCTINOXATE; ZINC OXIDE 75; 105 mg/g; mg/g 62032-122_1c47a19e-7f7f-4f41-ba99-cfec10da4d54 62032-122 HUMAN PRESCRIPTION DRUG OBAGI C RX SYSTEM C CLARIFYING SERUM HYDROQUINONE LIQUID TOPICAL 20100101 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE 40 mg/mL Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 62032-123_2cb83041-b6cf-4af3-9070-98c90eb95482 62032-123 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL TOPICAL 20060713 ANDA ANDA077547 Obagi Medical Products, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 62032-124_c9df5cc8-c811-416c-9e8a-b7eba0d49b3e 62032-124 HUMAN OTC DRUG NU-DERM SUN SHIELD SPF 50 SUNSCREEN ZINC OXIDE and OCTINOXATE LOTION TOPICAL 20110105 OTC MONOGRAPH FINAL part352 OMP, Inc. OCTINOXATE; ZINC OXIDE 75; 105 mg/mL; mg/mL 62032-125_b44e4803-13ea-4cef-a8fb-588b125f631c 62032-125 HUMAN OTC DRUG SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN OCTINOXATE and ZINC OXIDE LOTION TOPICAL 20130221 OTC MONOGRAPH FINAL part352 OMP, Inc. OCTINOXATE; ZINC OXIDE 75; 105 mg/g; mg/g 62032-128_a0e2a7ea-16d3-43fc-9a22-ca623591a0a9 62032-128 HUMAN OTC DRUG Professional-C Suncare Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20140102 OTC MONOGRAPH FINAL part352 Obagi Medical Products, Inc., a division of Valeant Pharmaceutcals North America LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 27.9; 30 mg/g; mg/g; mg/g; mg/g; mg/g 62032-129_db6fb272-6194-432d-a05c-7b87c11bd373 62032-129 HUMAN OTC DRUG DAILY CARE FOAMING CLEANSER ACNE TREATMENT SALICYLIC ACID LIQUID TOPICAL 20130118 OTC MONOGRAPH FINAL part333D OMP, INC. SALICYLIC ACID 20 mg/mL 62032-130_c80c7ea6-4962-492e-916f-637c2b2eb8df 62032-130 HUMAN OTC DRUG GENTLE REJUVENATION FORTIFIED SUNSCREEN BROAD SPECTRUM SPF 30 WITH VITAMIN C AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20131104 OTC MONOGRAPH FINAL part352 Obagi Medical Products, Inc., a division of Valeant Pharmaceutcals North America LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 27.9; 30 mg/g; mg/g; mg/g; mg/g; mg/g 62032-131_8a08641b-a4e3-4049-bcec-42386cf339b5 62032-131 HUMAN OTC DRUG GENTLE REJUVENATION ULTRA LIGHT REPAIR SPF 30 SUNSCREEN HOMOSALATE, OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE CREAM TOPICAL 20131015 OTC MONOGRAPH FINAL part352 Obagi Medical Products, Inc., a division of Valeant Pharmaceutcals North America LLC. HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 120; 75; 20; 49 mg/g; mg/g; mg/g; mg/g 62032-200_042d6848-34d7-47ce-b087-55ca37c55c51 62032-200 HUMAN OTC DRUG NU-DERM HEALTHY SKIN PROTECTION SPF 35 OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20020101 OTC MONOGRAPH FINAL part352 OMP, Inc. OCTINOXATE; ZINC OXIDE 75; 90 mg/mL; mg/mL 62032-300_6a22eb2d-4fee-42db-903c-ab5fa1a88a0d 62032-300 HUMAN OTC DRUG Obagi 360 HydraFactor Moisturizing Broad Spectrum SPF 30 SUNSCREEN AVOBENZONE, OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20140102 OTC MONOGRAPH FINAL part352 OMP, INC. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 10; 75; 50; 50 mg/g; mg/g; mg/g; mg/g 62032-411_fda09c9d-efee-40dc-8030-065ceacd7a5c 62032-411 HUMAN PRESCRIPTION DRUG REFISSA TRETINOIN CREAM TOPICAL 20100222 ANDA ANDA076498 Obagi Medical Products, Inc. TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 62032-413_c003c29d-8545-4132-913e-9e398508be47 62032-413 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20140619 NDA AUTHORIZED GENERIC NDA022070 OMP, INC. TRETINOIN .05 g/100g Retinoid [EPC],Retinoids [Chemical/Ingredient] 62032-415_1d7d903c-f0da-49e9-9225-c27f1a3108c2 62032-415 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20131001 ANDA ANDA075265 OMP, INC. TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 62032-416_1d7d903c-f0da-49e9-9225-c27f1a3108c2 62032-416 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20131001 ANDA ANDA075213 OMP, INC. TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 62032-500_2f665c58-4e09-4531-903f-ad747b483d6b 62032-500 HUMAN PRESCRIPTION DRUG NU-DERM TRAVEL SET NORMAL/DRY SKIN TRANSFORMATION SYSTEM HYDROQUINONE, OCTINOXATE AND ZINC OXIDE KIT 20041202 UNAPPROVED DRUG OTHER OMP, INC. 62032-502_ae234121-7d92-4fb6-9cfc-854beee1d0dd 62032-502 HUMAN PRESCRIPTION DRUG NU-DERM STARTER SET NORMAL-OILY SKIN TRANSFORMATION SYSTEM Hydroquinone, Octinoxate, Oxybenzone and Zinc Oxide KIT 20041202 UNAPPROVED DRUG OTHER OMP, INC. 62032-504_3851b75b-c31b-44f8-9341-b541cc0b39f1 62032-504 HUMAN PRESCRIPTION DRUG NU-DERM STARTER SET NORMAL-DRY SKIN TRANSFORMATION SYSTEM Hydroquinone, Octinoxate, Oxybenzone and Zinc Oxide KIT 20070820 UNAPPROVED DRUG OTHER OMP, INC. 62032-507_4d112f06-a318-47da-8e30-0ca7d2d03583 62032-507 HUMAN PRESCRIPTION DRUG ROSACLEAR SYSTEM METRONIDAZOLE KIT 20121229 UNAPPROVED DRUG OTHER OMP, INC. 62032-508_1456162c-eff9-4b7b-857e-08eb5a63aa86 62032-508 HUMAN PRESCRIPTION DRUG CONDITION AND ENHANCE SYSTEM TRAVEL-SIZE SURGICAL HYDROQUINONE, OCTINOXATE AND ZINC OXIDE KIT 20070820 UNAPPROVED DRUG OTHER OMP, INC. 62032-509_52e24f57-3062-4c19-902d-f98e72489b0f 62032-509 HUMAN PRESCRIPTION DRUG CONDITION AND ENHANCE SYSTEM FULL-SIZE NON-SURGICAL HYDROQUINONE, OCTINOXATE AND ZINC OXIDE KIT 20070820 UNAPPROVED DRUG OTHER OMP, INC. 62032-510_5a4e3679-60da-4c02-b325-5b7aafafb375 62032-510 HUMAN PRESCRIPTION DRUG CONDITION AND ENHANCE SYSTEM TRAVEL-SIZE NON-SURGICAL HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE KIT 20070820 UNAPPROVED DRUG OTHER OMP, INC. 62032-511_c048c2d1-4ebd-49dd-a8e4-0c374cd20c1e 62032-511 HUMAN OTC DRUG CLENZIDERM NORMAL TO OILY SKIN ACNE THERAPEUTIC SYSTEM SALICYLIC ACID AND BENZOYL PEROXIDE KIT 20120101 OTC MONOGRAPH FINAL part333D OMP, INC. 62032-512_7749e53b-e9fa-46ee-b071-cbb3e079afc1 62032-512 HUMAN OTC DRUG CLENZIDERM NORMAL TO DRY SKIN ACNE THERAPEUTIC SYSTEM GLYCERIN AND BENZOYL PEROXIDE KIT 20070701 OTC MONOGRAPH FINAL part333D OMP, INC. 62032-513_76204b7d-f856-4aa7-91d3-a04432eb9254 62032-513 HUMAN PRESCRIPTION DRUG NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION Hydroquinone, Octinoxate, and Zinc Oxide KIT 20121107 UNAPPROVED DRUG OTHER OMP, INC. 62032-514_53845d82-8e3c-4498-89e0-1568174f8524 62032-514 HUMAN PRESCRIPTION DRUG NU-DERM SYSTEM NORMAL-DRY SKIN TRANSFORMATION Hydroquinone, Octinoxate,and Zinc Oxide KIT 20121107 UNAPPROVED DRUG OTHER OMP, INC. 62032-515_d36cbefa-07dd-41d4-9779-95759906373b 62032-515 HUMAN PRESCRIPTION DRUG NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION TRIAL Hydroquinone, Octinoxate, and Zinc Oxide KIT 20121107 UNAPPROVED DRUG OTHER OMP, INC. 62032-516_5d0f2798-b997-4b8f-932b-50778521359c 62032-516 HUMAN PRESCRIPTION DRUG NU-DERM SYSTEM NORMAL-DRY SKIN TRANSFORMATION TRIAL Hydroquinone, Octinoxate, and Zinc Oxide KIT 20121107 UNAPPROVED DRUG OTHER OMP, INC. 62032-517_ba2c32e0-568f-419b-8798-a75bc089cb2d 62032-517 HUMAN PRESCRIPTION DRUG OBAGI-C RX SYSTEM NORMAL-OILY SKIN INTERVENTION HYDROQUINONE, OCTINOXATE AND ZINC OXIDE KIT 20121107 UNAPPROVED DRUG OTHER OMP, INC. 62032-518_aba5eec8-1945-4753-b301-bc612936cec1 62032-518 HUMAN PRESCRIPTION DRUG OBAGI-C RX SYSTEM NORMAL-DRY SKIN INTERVENTION HYDROQUINONE, OCTINOXATE AND ZINC OXIDE KIT 20121107 UNAPPROVED DRUG OTHER OMP, INC. 62032-520_1be2dfad-d98e-4b0d-9d07-4820deb8e2aa 62032-520 HUMAN PRESCRIPTION DRUG NU-DERM SYSTEM NORMAL-DRY SKIN TRANSFORMATION Hydroquinone, Octinoxate, and Zinc Oxide KIT 20130415 UNAPPROVED DRUG OTHER OMP, INC. 62032-522_25fd5bb4-16d0-408c-b0dd-5e6981f225d7 62032-522 HUMAN PRESCRIPTION DRUG NU-DERM SYSTEM NORMAL-DRY SKIN TRANSFORMATION TRIAL Hydroquinone, Octinoxate,and Zinc Oxide KIT 20130415 UNAPPROVED DRUG OTHER OMP, INC. 62032-523_eef1e733-50fb-43cc-9579-0d55175e32ec 62032-523 HUMAN PRESCRIPTION DRUG OBAGI-C RX SYSTEM NORMAL-OILY SKIN INTERVENTION HYDROQUINONE, OCTINOXATE AND ZINC OXIDE KIT 20130402 UNAPPROVED DRUG OTHER OMP, INC. 62032-524_392f9428-6f3f-44ba-8719-fdf26aca7800 62032-524 HUMAN PRESCRIPTION DRUG OBAGI-C RX SYSTEM NORMAL-DRY SKIN INTERVENTION HYDROQUINONE, OCTINOXATE AND ZINC OXIDE KIT 20130402 UNAPPROVED DRUG OTHER OMP, INC. 62032-525_bd8edc0e-4bb1-41f9-9d04-e3289f92bd9b 62032-525 HUMAN OTC DRUG GENTLE REJUVENATION SYSTEM AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE KIT 20131104 OTC MONOGRAPH FINAL part352 Obagi Medical Products, Inc., a division of Valeant Pharmaceutcals North America LLC. 62034-011_630e8bbf-a0c1-4886-9c6e-a5d6f94d3b9e 62034-011 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20140311 ANDA ANDA090548 Blenheim Pharmacal, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 62034-012_630e8bbf-a0c1-4886-9c6e-a5d6f94d3b9e 62034-012 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20140311 ANDA ANDA090548 Blenheim Pharmacal, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 62034-013_630e8bbf-a0c1-4886-9c6e-a5d6f94d3b9e 62034-013 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20140311 ANDA ANDA090548 Blenheim Pharmacal, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 62034-014_630e8bbf-a0c1-4886-9c6e-a5d6f94d3b9e 62034-014 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20140311 ANDA ANDA090548 Blenheim Pharmacal, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 62034-015_3f359649-2dea-4ec0-a2de-d246eb0ba13c 62034-015 HUMAN PRESCRIPTION DRUG clopidogrel bisulfate clopidogrel bisulfate TABLET, FILM COATED ORAL 20140214 ANDA ANDA076274 Blenheim Pharmacal, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 62035-169_79a97674-baac-4110-aa69-29053d73ef33 62035-169 HUMAN PRESCRIPTION DRUG Oxygen, Compressed OXYGEN GAS RESPIRATORY (INHALATION) 20101222 UNAPPROVED MEDICAL GAS Frontier Medical Equipment, Inc. OXYGEN 1 L/L 62037-524_5940f55f-2824-43c9-871b-6d4d2dffa970 62037-524 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED ORAL 20040401 ANDA ANDA076604 Actavis Pharma, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 62037-559_2d98c278-91c6-4620-b206-8016daead33e 62037-559 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20080825 ANDA ANDA077419 Watson Pharma, Inc. POTASSIUM CHLORIDE 8 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 62037-560_2d98c278-91c6-4620-b206-8016daead33e 62037-560 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20080825 ANDA ANDA077419 Watson Pharma, Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 62037-567_d09271e4-abad-40e2-94cc-0472eea94d78 62037-567 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20030528 ANDA ANDA040495 Watson Pharma, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 660; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 62037-571_52eb1795-78fb-49fe-a193-0fc67bc1c469 62037-571 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20040616 ANDA ANDA076172 Watson Pharma, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 62037-577_52eb1795-78fb-49fe-a193-0fc67bc1c469 62037-577 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20050412 ANDA ANDA076869 Watson Pharma, Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 62037-597_706be134-2892-43f0-a819-ba0b7a9010c4 62037-597 HUMAN PRESCRIPTION DRUG Cartia XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19990623 ANDA ANDA074752 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62037-598_706be134-2892-43f0-a819-ba0b7a9010c4 62037-598 HUMAN PRESCRIPTION DRUG Cartia XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19990623 ANDA ANDA074752 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62037-599_706be134-2892-43f0-a819-ba0b7a9010c4 62037-599 HUMAN PRESCRIPTION DRUG Cartia XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19990623 ANDA ANDA074752 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62037-600_706be134-2892-43f0-a819-ba0b7a9010c4 62037-600 HUMAN PRESCRIPTION DRUG Cartia XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19990623 ANDA ANDA074752 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62037-610_130edf56-af4a-4b71-b893-cb7f6908f045 62037-610 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20080725 ANDA ANDA075347 Actavis Pharma, Inc. OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 62037-620_130edf56-af4a-4b71-b893-cb7f6908f045 62037-620 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20080725 ANDA ANDA075347 Actavis Pharma, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 62037-640_130edf56-af4a-4b71-b893-cb7f6908f045 62037-640 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20080725 ANDA ANDA075347 Actavis Pharma, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 62037-667_f5d92577-f51f-4dc1-8401-ab1ebccbdcec 62037-667 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110225 ANDA ANDA079080 Watson Pharma, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 62037-674_52eb1795-78fb-49fe-a193-0fc67bc1c469 62037-674 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075961 Watson Pharma, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 62037-675_52eb1795-78fb-49fe-a193-0fc67bc1c469 62037-675 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075961 Watson Pharma, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 62037-676_52eb1795-78fb-49fe-a193-0fc67bc1c469 62037-676 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075961 Watson Pharma, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 62037-690_0f490ac8-098e-4677-becc-1887794dad21 62037-690 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100315 ANDA ANDA077686 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62037-691_0f490ac8-098e-4677-becc-1887794dad21 62037-691 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100315 ANDA ANDA077686 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62037-692_0f490ac8-098e-4677-becc-1887794dad21 62037-692 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100315 ANDA ANDA077686 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62037-693_0f490ac8-098e-4677-becc-1887794dad21 62037-693 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100315 ANDA ANDA077686 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62037-694_0f490ac8-098e-4677-becc-1887794dad21 62037-694 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100315 ANDA ANDA077686 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62037-695_0f490ac8-098e-4677-becc-1887794dad21 62037-695 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100315 ANDA ANDA077686 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62037-696_fcb8848b-384e-421a-802d-360a6ce384fd 62037-696 HUMAN PRESCRIPTION DRUG TAZTIA XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030410 ANDA ANDA075401 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62037-697_fcb8848b-384e-421a-802d-360a6ce384fd 62037-697 HUMAN PRESCRIPTION DRUG TAZTIA XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030410 ANDA ANDA075401 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62037-698_fcb8848b-384e-421a-802d-360a6ce384fd 62037-698 HUMAN PRESCRIPTION DRUG TAZTIA XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030410 ANDA ANDA075401 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62037-699_fcb8848b-384e-421a-802d-360a6ce384fd 62037-699 HUMAN PRESCRIPTION DRUG TAZTIA XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030410 ANDA ANDA075401 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62037-700_fcb8848b-384e-421a-802d-360a6ce384fd 62037-700 HUMAN PRESCRIPTION DRUG TAZTIA XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030410 ANDA ANDA075401 Watson Pharma, Inc. DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62037-710_1adf9824-63fb-4ec2-8dcd-61c68b4d00ca 62037-710 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020410 ANDA ANDA075604 Watson Pharma, Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 62037-720_1adf9824-63fb-4ec2-8dcd-61c68b4d00ca 62037-720 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020410 ANDA ANDA075604 Watson Pharma, Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 62037-777_5f3ed772-c547-407f-b884-c3396d3a3f28 62037-777 HUMAN PRESCRIPTION DRUG clarithromycin clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080101 20150731 ANDA ANDA065145 Watson Pharma, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 62037-830_d2b7e339-32d1-4da2-a871-9b60b97b733a 62037-830 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA077118 Watson Pharma, Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 62037-831_d2b7e339-32d1-4da2-a871-9b60b97b733a 62037-831 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA076862 Watson Pharma, Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 62037-832_d2b7e339-32d1-4da2-a871-9b60b97b733a 62037-832 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100415 ANDA ANDA077298 Watson Pharma, Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 62037-833_d2b7e339-32d1-4da2-a871-9b60b97b733a 62037-833 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100415 ANDA ANDA077298 Watson Pharma, Inc. METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 62037-839_087671b1-df17-4c94-b1be-6c491b50db1d 62037-839 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20120127 ANDA ANDA076684 Watson Pharma, Inc. ENOXAPARIN SODIUM 30 mg/.3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62037-849_087671b1-df17-4c94-b1be-6c491b50db1d 62037-849 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20120127 ANDA ANDA076684 Watson Pharma, Inc. ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62037-861_087671b1-df17-4c94-b1be-6c491b50db1d 62037-861 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20120127 ANDA ANDA076684 Watson Pharma, Inc. ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62037-862_087671b1-df17-4c94-b1be-6c491b50db1d 62037-862 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20120127 ANDA ANDA076684 Watson Pharma, Inc. ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62037-863_087671b1-df17-4c94-b1be-6c491b50db1d 62037-863 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20120127 ANDA ANDA076684 Watson Pharma, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62037-864_087671b1-df17-4c94-b1be-6c491b50db1d 62037-864 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20120127 ANDA ANDA076684 Watson Pharma, Inc. ENOXAPARIN SODIUM 120 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62037-866_087671b1-df17-4c94-b1be-6c491b50db1d 62037-866 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20120127 ANDA ANDA076684 Watson Pharma, Inc. ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62037-938_b61a9cbe-8ae4-4f0f-9fbe-4bd1fe634043 62037-938 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101130 ANDA ANDA077809 Watson Pharma, Inc. CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 425.2; 574.9 mg/1; mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 62037-942_b61a9cbe-8ae4-4f0f-9fbe-4bd1fe634043 62037-942 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101130 ANDA ANDA077417 Watson Pharma, Inc. CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 212.6; 287.5 mg/1; mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 62037-999_b12bd1b1-55ac-4575-b8b5-9b8ab7ba7b07 62037-999 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20040818 ANDA ANDA076368 Watson Pharma, Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 62040-1001_05fb5be5-547a-4558-8bf4-cf9d7efb007e 62040-1001 HUMAN OTC DRUG Eco Whitening HYDROGEN PEROXIDE GEL DENTAL 20140208 UNAPPROVED DRUG OTHER JN Pharm HYDROGEN PEROXIDE 8.57 g/100mL 62040-2001_a617a4e0-2f51-4da9-8990-ba6bbd7b0159 62040-2001 HUMAN OTC DRUG E-zen Gargle CETYLPYRIDINIUM CHLORIDE LIQUID DENTAL 20140208 UNAPPROVED DRUG OTHER JN Pharm CETYLPYRIDINIUM CHLORIDE .005 g/100mL 62041-010_0a0d3edb-8dc1-48fd-a3a2-e311cc102079 62041-010 HUMAN OTC DRUG AAPE Skin Ampoule Allantoin SOLUTION TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. ALLANTOIN .03 mg/61 62041-020_9bfaf0b5-2945-4b99-98ee-77caba13b6c1 62041-020 HUMAN OTC DRUG AAPE Hair Ampoule Allantoin SOLUTION TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. ALLANTOIN .03 mg/61 62041-030_1d8c3062-0b6e-4bf8-b449-07729ed95c0a 62041-030 HUMAN OTC DRUG AAPE Continuous Renewal Sun OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 Prostemics Co., Ltd. OCTINOXATE; ZINC OXIDE 4.5; 1.68 mg/60mL; mg/60mL 62041-040_746d28d2-a3ee-48b6-a061-8af948fdd1c1 62041-040 HUMAN OTC DRUG AAPE Nutrient Facial Toner WITCH HAZEL LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. WITCH HAZEL .325 mg/130mL 62041-050_85144b98-d0f4-4232-b293-1f1cad239257 62041-050 HUMAN OTC DRUG AAPE Continuous Renewal Serum WITCH HAZEL CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. WITCH HAZEL .2 mg/40mL 62041-060_31437413-071a-42b7-af37-a03b10400ada 62041-060 HUMAN OTC DRUG AAPE Continuous Renewal Eye WITCH HAZEL CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. WITCH HAZEL .1 mg/20mL 62041-070_221cfdb7-5401-4e8c-b17e-95620e0a25b9 62041-070 HUMAN OTC DRUG AAPE Continuous Renewal WITCH HAZEL CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. WITCH HAZEL .25 mg/50mL 62041-080_596f6486-71a1-41ad-9e5d-2e47c58becca 62041-080 HUMAN OTC DRUG AAPE Continuous Renewal Mask WITCH HAZEL PATCH TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. WITCH HAZEL .15 mg/101 62045-4333_bf6e63c1-4017-4ef2-8e50-e8660d9934ab 62045-4333 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19860101 UNAPPROVED MEDICAL GAS NLR Welding Supply, Inc. OXYGEN 99 L/100L 62045-6333_7bd1adad-fe92-4a1a-aad5-83c0c6fe506c 62045-6333 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19860101 UNAPPROVED MEDICAL GAS NLR Welding Supply, Inc. NITROGEN 99 L/100L 62046-001_f841e865-adfd-4efd-955d-e06364369b5d 62046-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140131 UNAPPROVED MEDICAL GAS Cook Children's Home Health OXYGEN 99 L/100L 62064-011_49e2ff57-88f3-4fe6-9b28-7ad5cc6a98ce 62064-011 HUMAN PRESCRIPTION DRUG Egrifta tesamorelin KIT SUBCUTANEOUS 20140714 NDA NDA022505 Theratechnologies Inc. 62065-514_b063dbb1-4537-4e18-b272-aa9b80d73f92 62065-514 HUMAN OTC DRUG Sport Mate Non-Alcohol Foaming Instant Hand Sanitizer HUSKY 514 SOLUTION TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 Stone Soap Company, Inc. BENZALKONIUM CHLORIDE 1 g/1000mL 62072-456_6141678a-59e0-4c56-b726-1a22b76523a7 62072-456 HUMAN PRESCRIPTION DRUG Ammonia N 13 AMMONIA N-13 INJECTION INTRAVENOUS 20131209 ANDA ANDA203938 Kreitchman PET Center AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 62080-0101_3faf1f6d-1ad9-4336-a136-de55b241661c 62080-0101 HUMAN OTC DRUG Ruby-Cell 4U Ampoule GLYCERIN LIQUID TOPICAL 20140716 OTC MONOGRAPH FINAL part347 Dasan E&T Co., Ltd. GLYCERIN .06 g/mL 62080-1001_1f0fc629-b3e1-482b-844f-4b47a286cb4f 62080-1001 HUMAN OTC DRUG Ruby-Cell 4U Bio Cellulose Mask GLYCERIN PATCH TOPICAL 20140210 OTC MONOGRAPH FINAL part347 Dasan E&T Co., Ltd. GLYCERIN .05 g/mL 62080-2001_b968c7bf-ca53-4d73-9aa0-72c9d4ab9250 62080-2001 HUMAN OTC DRUG Ruby-Cell 4U Ampoule GLYCERIN LIQUID TOPICAL 20140210 OTC MONOGRAPH FINAL part347 Dasan E&T Co., Ltd. GLYCERIN .06 g/mL 62080-3001_ae769c6b-90f8-4073-a349-76686da258e6 62080-3001 HUMAN OTC DRUG Ruby-Cell 4U GLYCERIN CREAM TOPICAL 20140210 OTC MONOGRAPH FINAL part347 Dasan E&T Co., Ltd. GLYCERIN .03 g/mL 62080-4001_54596bc2-df95-4610-8c65-6add0da7ede8 62080-4001 HUMAN OTC DRUG Ruby-Cell 4U Mist GLYCERIN LIQUID TOPICAL 20140210 OTC MONOGRAPH FINAL part347 Dasan E&T Co., Ltd. GLYCERIN .02 g/mL 62080-5001_1da021a9-5809-4093-a94d-a2f780802d7c 62080-5001 HUMAN OTC DRUG Atorak Ampoule GLYCERIN LIQUID TOPICAL 20140210 OTC MONOGRAPH FINAL part347 Dasan E&T Co., Ltd. GLYCERIN .06 g/mL 62080-6001_b2bc5332-acea-4143-8410-da7c8228d7a7 62080-6001 HUMAN OTC DRUG Atorak Intensive Mousture GLYCERIN CREAM TOPICAL 20140210 OTC MONOGRAPH FINAL part347 Dasan E&T Co., Ltd. GLYCERIN .03 g/mL 62080-7001_4bf1e635-468d-4173-94e8-559b0d4c3204 62080-7001 HUMAN OTC DRUG Ruby-Cell 4U Essential Silky Foaming Cleanser GLYCERIN LIQUID TOPICAL 20140213 OTC MONOGRAPH FINAL part347 Dasan E&T Co., Ltd. GLYCERIN .07 g/mL 62080-8001_2a96c5d5-58d4-4160-9699-17eb4288205a 62080-8001 HUMAN OTC DRUG Ruby-Cell 4U B B 10 in 1 GLYCERIN LIQUID TOPICAL 20140213 OTC MONOGRAPH FINAL part347 Dasan E&T Co., Ltd. GLYCERIN .03 g/g 62080-8002_c3ecbb97-389a-4ffe-bb0b-4b29ada8c949 62080-8002 HUMAN OTC DRUG Ruby-Cell 4U B B 10 in 1 GLYCERIN CREAM TOPICAL 20140213 OTC MONOGRAPH FINAL part347 Dasan E&T Co., Ltd. GLYCERIN .03 g/g 62080-9001_b23ad9f0-b48c-446a-87f9-6a0efa3fa441 62080-9001 HUMAN OTC DRUG Ruby-Cell 4U Mist GLYCERIN LIQUID TOPICAL 20140210 OTC MONOGRAPH FINAL part347 Dasan E&T Co., Ltd. GLYCERIN .02 g/mL 62082-100_daabcd6d-574a-4b71-8ce9-f2d39ae873bf 62082-100 HUMAN OTC DRUG Arnica Montana ARNICA MONTANA PELLET TOPICAL 20140201 UNAPPROVED HOMEOPATHIC Pharmaca Integrative Pharmacy ARNICA MONTANA 30 [hp_C]/1 62085-1001_89106510-cd9c-4dea-aa68-8fdb164db8e6 62085-1001 HUMAN OTC DRUG GIM ASIAN GINSENG LIQUID TOPICAL 20140208 UNAPPROVED DRUG OTHER Halim Pharm Ltd ASIAN GINSENG 24 g/100mL 62097-0003_d18001f1-79db-4872-aa07-b2a6cb142b2e 62097-0003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19950928 UNAPPROVED MEDICAL GAS Boggs Gases div. Boggs Fire Equipment NITROGEN 99 mL/L 62097-0006_d18001f1-79db-4872-aa07-b2a6cb142b2e 62097-0006 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19950928 UNAPPROVED MEDICAL GAS Boggs Gases div. Boggs Fire Equipment NITROUS OXIDE 99 mL/L 62097-9937_d18001f1-79db-4872-aa07-b2a6cb142b2e 62097-9937 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19950928 UNAPPROVED MEDICAL GAS Boggs Gases div. Boggs Fire Equipment OXYGEN 99 L/100L 62106-0001_0a46b08f-86cc-6cc7-e054-00144ff88e88 62106-0001 HUMAN OTC DRUG PharMax Nerve Capsicum CREAM TOPICAL 20141210 UNAPPROVED HOMEOPATHIC Seroyal USA CAPSICUM 2 [hp_C]/70g 62106-0002_0a46b08f-86bc-6cc7-e054-00144ff88e88 62106-0002 HUMAN OTC DRUG PharMax Relief Ruta graveolens CREAM TOPICAL 20141202 UNAPPROVED HOMEOPATHIC Seroyal USA RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]/70g 62106-0003_0a46b08f-86cb-6cc7-e054-00144ff88e88 62106-0003 HUMAN OTC DRUG PharMax Heal Calendula CREAM TOPICAL 20141205 UNAPPROVED HOMEOPATHIC Seroyal USA CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_C]/70g 62106-0004_09f7d0df-3d5f-25b2-e054-00144ff8d46c 62106-0004 HUMAN OTC DRUG pharMAX rebuild Arnica Montana CREAM TOPICAL 20141205 UNAPPROVED HOMEOPATHIC Seroyal USA ARNICA MONTANA 5 [hp_C]/70g 62106-0005_0a46b08f-86c2-6cc7-e054-00144ff88e88 62106-0005 HUMAN OTC DRUG pharMAX fibro Capsicum annuum L , Kali phosphoricum , Phosphorus CREAM TOPICAL 20141205 UNAPPROVED HOMEOPATHIC Seroyal USA CAPSICUM; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC 5; 8; 8 [hp_C]/70g; [hp_X]/70g; [hp_X]/70g 62106-0006_0a46b08f-86bf-6cc7-e054-00144ff88e88 62106-0006 HUMAN OTC DRUG pharMAX varicose Hamamelis virginiana L CREAM TOPICAL 20141205 UNAPPROVED HOMEOPATHIC Seroyal USA HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 5 [hp_C]/70g 62106-1100_0a46ce49-e24e-6177-e054-00144ff88e88 62106-1100 HUMAN OTC DRUG Unda 1 ACHILLEA MILLEFOLIUM LIQUID ORAL 20140701 UNAPPROVED HOMEOPATHIC Seroyal USA ACHILLEA MILLEFOLIUM; ANGELICA ARCHANGELICA ROOT; ARCTOSTAPHYLOS UVA-URSI LEAF; EQUISETUM ARVENSE TOP; LARIX DECIDUA RESIN; LYCOPODIUM CLAVATUM SPORE; SILVER; VALERIAN 4; 4; 4; 4; 5; 4; 12; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL 62106-1112_0a6be318-a46a-385b-e054-00144ff8d46c 62106-1112 HUMAN OTC DRUG Unda 13 Boldo Leaf, Ricinus communis Seed, Combretum raimbaultii Leaf, Jateorhiza palmata Root, Argentum metallicum LIQUID ORAL 20141217 UNAPPROVED HOMEOPATHIC Seroyal USA COMBRETUM MICRANTHUM LEAF; JATEORHIZA CALUMBA ROOT; PEUMUS BOLDUS LEAF; RICINUS COMMUNIS SEED; SILVER 4; 4; 4; 4; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL 62106-1143_0a6df6e1-fe51-0f3e-e054-00144ff8d46c 62106-1143 HUMAN OTC DRUG Unda 44 Inula helenium Root, Juniperus communis berry, Uva-ursi Leaf, Dulcamara Stem and Leaf, Cytisus scoparius Aerial Parts, Stigmata maidis Style and Stigma, Argentum metallicum, Aurum metallicum LIQUID ORAL 20141217 UNAPPROVED HOMEOPATHIC Seroyal USA ARCTOSTAPHYLOS UVA-URSI LEAF; CORN SILK; CYTISUS SCOPARIUS FLOWERING TOP; GOLD; INULA HELENIUM ROOT; JUNIPER BERRY; SILVER; SOLANUM DULCAMARA STEM 4; 4; 4; 12; 4; 4; 12; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL 62106-1159_0a709bd8-01c2-02e2-e054-00144ff8d46c 62106-1159 HUMAN OTC DRUG Unda 228 Valeriana officinalis Root, Melissa officinalis Whole Plant, Verbena officinalis Whole Plant, Millefolium Whole Plant, Thymus vulgaris Aerial Parts, Passiflora incarnata Aerial Parts, Lactuca virosa Whole Plant LIQUID ORAL 20141217 UNAPPROVED HOMEOPATHIC Seroyal USA ACHILLEA MILLEFOLIUM; LACTUCA VIROSA; MELISSA OFFICINALIS; PASSIFLORA INCARNATA FLOWERING TOP; THYME; VALERIAN; VERBENA OFFICINALIS 4; 4; 4; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL 62106-1201_0a821396-771a-1021-e054-00144ff88e88 62106-1201 HUMAN OTC DRUG Chelidonium Plex Chelidonium majus, Carduus marianus, Solidago virgaurea, Berberis vulgaris, Dolichos pruriens, Iris versicolor, Ptelea trifoliata, Taraxacum officinale LIQUID ORAL 20141217 UNAPPROVED HOMEOPATHIC Seroyal USA BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; IRIS VERSICOLOR ROOT; MILK THISTLE; MUCUNA PRURIENS FRUIT TRICHOME; PTELEA TRIFOLIATA BARK; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE 10; 10; 10; 3; 10; 10; 3; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 62106-1235_0a5dc531-45b0-3f13-e054-00144ff8d46c 62106-1235 HUMAN OTC DRUG Melange combination Calcarea sulphurica, Calcium phosphoricum, Kali muriaticum, Kalium phosphoricum, Kali sulphuricum, Magnesia phosphorica, Natrum muriaticum, Natrum phosphoricum, Natrium sulfuricum, Calcarea fluorica, Ferrum phosphoricum, Silicea TABLET ORAL 20141212 UNAPPROVED HOMEOPATHIC Seroyal USA CALCIUM FLUORIDE; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE 12; 6; 6; 12; 6; 6; 6; 6; 12; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 62106-6870_0a46b08f-86c5-6cc7-e054-00144ff88e88 62106-6870 HUMAN OTC DRUG Muco coccinum KLEBSIELLA PNEUMONIAE TABLET SUBLINGUAL 20141015 UNAPPROVED HOMEOPATHIC Seroyal USA ANAEROCOCCUS TETRADIUS; INFLUENZA A VIRUS; INFLUENZA B VIRUS; KLEBSIELLA PNEUMONIAE; MORAXELLA CATARRHALIS SUBSP. CATARRHALIS 200; 200; 200; 200; 200 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 62107-002_0ad3cd6e-8c67-1f0a-e054-00144ff88e88 62107-002 HUMAN OTC DRUG HEALTH SENSE PROVIL ibuprofen TABLET, FILM COATED ORAL 20060101 ANDA ANDA075010 Prime Marketing, LLC IBUPROFEN 200 mg/1 62107-026_0a7ffe70-a862-003e-e054-00144ff8d46c 62107-026 HUMAN OTC DRUG HEALTH SENSE Adult Chewable Low Strength Aspirin Aspirin TABLET, CHEWABLE ORAL 20061001 OTC MONOGRAPH NOT FINAL part343 Prime Marketing, LLC ASPIRIN 81 mg/1 62107-027_0ae75975-fa66-5cf6-e054-00144ff8d46c 62107-027 HUMAN OTC DRUG HEALTH SENSE ASPIRIN 81 Aspirin TABLET, COATED ORAL 20060701 OTC MONOGRAPH FINAL part343 Prime Marketing, LLC ASPIRIN 81 mg/1 62107-028_0af864ea-11dc-4b25-e054-00144ff8d46c 62107-028 HUMAN OTC DRUG HEALTH SENSE ECPIRIN Aspirin TABLET, COATED ORAL 20061201 OTC MONOGRAPH FINAL part343 Prime Marketing, LLC ASPIRIN 325 mg/1 62107-030_0a66d57a-4343-5c87-e054-00144ff88e88 62107-030 HUMAN OTC DRUG HEALTH SENSE DUCODYL Bisacodyl TABLET, COATED ORAL 20060701 OTC MONOGRAPH NOT FINAL part334 Prime Marketing, LLC BISACODYL 5 mg/1 62107-031_0a6f69bf-744e-5e18-e054-00144ff8d46c 62107-031 HUMAN OTC DRUG HEALTH SENSE SENNO Sennosides TABLET ORAL 20051101 OTC MONOGRAPH NOT FINAL part334 Prime Marketing, LLC SENNOSIDES 8.6 mg/1 62107-033_0a6a5f56-3922-53b1-e054-00144ff8d46c 62107-033 HUMAN OTC DRUG HEALTH SENSE DOCUSIL Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20070901 OTC MONOGRAPH NOT FINAL part334 Prime Marketing, LLC DOCUSATE SODIUM 100 mg/1 62107-050_0a5aa713-91a5-29e7-e054-00144ff8d46c 62107-050 HUMAN OTC DRUG HEALTH SENSE TACTINAL Extra Strength Acetaminophen TABLET ORAL 20060801 OTC MONOGRAPH NOT FINAL part343 Prime Marketing, LLC ACETAMINOPHEN 500 mg/1 62107-051_0a5b8720-dec6-4cb2-e054-00144ff88e88 62107-051 HUMAN OTC DRUG HEALTH SENSE TACTINAL Extra Strength Acetaminophen TABLET ORAL 20060801 OTC MONOGRAPH NOT FINAL part343 Prime Marketing, LLC ACETAMINOPHEN 500 mg/1 62107-052_0a46ce49-e271-6177-e054-00144ff88e88 62107-052 HUMAN OTC DRUG HEALTH SENSE TACTINAL Regular Strength Acetaminophen TABLET ORAL 20060801 OTC MONOGRAPH NOT FINAL part343 Prime Marketing, LLC ACETAMINOPHEN 325 mg/1 62111-0210_7882cc7e-d04e-4565-8366-b1ebf167aed8 62111-0210 HUMAN OTC DRUG LIP ENHANCER GLOSS SUNSCREEN BROAD SPECTRUM SPF15 AVOBENZONE, OCTINOXATE, OCTISALATE GEL TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 AKG Innovations LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 30 mg/mL; mg/mL; mg/mL 62111-0211_0266a461-597c-4ad7-999c-9e070c2e063f 62111-0211 HUMAN OTC DRUG Moisturizing Lip BalmSPF30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 AKG Innovations LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25; 80; 50; 22; 30 mg/g; mg/g; mg/g; mg/g; mg/g 62111-0212_31539b3c-ad6e-4c7f-b464-2c5ed6daa711 62111-0212 HUMAN OTC DRUG PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH Sodium Fluoride MOUTHWASH ORAL 20140214 OTC MONOGRAPH FINAL part355 AKG Innovations LLC SODIUM FLUORIDE .2 mg/mL 62111-0213_7a426e80-7e89-4f1e-8c92-0c6c09abd0ac 62111-0213 HUMAN OTC DRUG PROFESSIONAL WHITENING SYSTEM WHITENING SODIUM FLUORIDE PASTE DENTAL 20140214 OTC MONOGRAPH FINAL part355 AKG Innovations LLC SODIUM FLUORIDE .23 g/100g 62112-8045_df630daf-d7c0-4d7e-9fa5-0306ddb4769f 62112-8045 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine CAPSULE, LIQUID FILLED ORAL 20090801 ANDA ANDA072781 IVC Industries, Inc. dba Inverness Medical Nutritionals Group NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 62135-626_8aa45a19-1e27-45cc-a470-23b8bd87ab1e 62135-626 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 Chartwell RX LLC DOXYCYCLINE HYCLATE 100 mg/1 62135-984_a71e1b9a-96c0-4755-ad63-5820a828e750 62135-984 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Chartwell RX LLC DOXYCYCLINE HYCLATE 50 mg/1 62135-985_a71e1b9a-96c0-4755-ad63-5820a828e750 62135-985 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Chartwell RX LLC DOXYCYCLINE HYCLATE 100 mg/1 62144-5510_2b072821-c4b6-4267-a6b1-844536e0b7e8 62144-5510 HUMAN OTC DRUG ImproVue HYPROMELLOSE 2208 (15000 MPA.S) SOLUTION/ DROPS OPHTHALMIC 20140625 OTC MONOGRAPH FINAL part349 Oculus Surgical, Inc. HYPROMELLOSE 2208 (15000 MPA.S) 17 mg/mL 62149-0002_39f9447a-f7c9-4c90-a3de-55577eff4b3c 62149-0002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19930101 UNAPPROVED MEDICAL GAS A.M. Home Diagnostics Inc. dba Healthline OXYGEN 99 L/100L 62168-0084_3146f5fd-2476-4217-915c-35c0332811cf 62168-0084 HUMAN OTC DRUG Icy Hot Medicated Menthol PATCH TOPICAL 20001101 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL 205.5 mg/1 62168-0085_3d69bc86-aa79-4f06-ab39-59aa41f82b54 62168-0085 HUMAN OTC DRUG Dorflex Icy Hot Flexible, Small Menthol PATCH TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL 205.5 mg/1 62168-0086_3d69bc86-aa79-4f06-ab39-59aa41f82b54 62168-0086 HUMAN OTC DRUG Dorflex Icy Hot Flexible, Large Menthol PATCH TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL 428.5 mg/1 62168-0087_3d69bc86-aa79-4f06-ab39-59aa41f82b54 62168-0087 HUMAN OTC DRUG Dorflex Icy Hot Flexible, XL Menthol PATCH TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL 750 mg/1 62168-0805_3146f5fd-2476-4217-915c-35c0332811cf 62168-0805 HUMAN OTC DRUG Icy Hot Medicated, Advanced Relief Menthol PATCH TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL 210 mg/1 62168-0843_3146f5fd-2476-4217-915c-35c0332811cf 62168-0843 HUMAN OTC DRUG Icy Hot Medicated, Back Menthol PATCH TOPICAL 20030301 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL 428.5 mg/1 62168-0847_3146f5fd-2476-4217-915c-35c0332811cf 62168-0847 HUMAN OTC DRUG Icy Hot Medicated, XL Menthol PATCH TOPICAL 20071201 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL 750 mg/1 62168-1000_9df40679-e915-4cc7-9e5e-805a253d0e7f 62168-1000 HUMAN OTC DRUG Icy Hot Back Menthol PATCH TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL 428.5 mg/1 62169-202_35842aa1-812f-42c1-a7bf-3a40e58ddfee 62169-202 HUMAN OTC DRUG MANUGEL 85 Ethanol GEL TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Laboratoires Anios ALCOHOL; PHENOXYETHANOL 400; .3 mL/500mL; g/500mL 62169-203_b39b4a9b-56e8-43f2-89d5-319b6cf2e337 62169-203 HUMAN OTC DRUG ANIOSGEL 85 NPC Ethanol GEL TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Laboratoires Anios ALCOHOL 377.5 mL/500mL 62171-010_8fad41f4-6ca7-45a4-8df8-70a31061a3fa 62171-010 HUMAN OTC DRUG DR MYERS WATER KEEP SKINS OCTINOXATE CREAM TOPICAL 20140102 OTC MONOGRAPH NOT FINAL part352 Coson Co., Ltd. OCTINOXATE 3.75 mg/50mL 62171-020_fd7b6468-5eaa-4ffd-9fc6-81e51010a2c1 62171-020 HUMAN OTC DRUG UV MILD SUN BLOCK OCTINOXATE CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Coson Co., Ltd. OCTINOXATE 3.75 mg/50mL 62171-030_3fc805e4-186d-4186-9697-f978aa8e0fff 62171-030 HUMAN OTC DRUG SNAIL REPAIR BLEMISH BALM OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Coson Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.82; 4.49; .38 mg/50mL; mg/50mL; mg/50mL 62171-040_f1481a72-8926-4063-b8e9-d39b2b029f6e 62171-040 HUMAN OTC DRUG CRYSTAL MIRACLE MULTI OCTINOXATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Coson Co., Ltd. OCTINOXATE 3.75 mg/50mL 62171-050_fcf80cb4-7763-4ab4-b60f-3103f3e48534 62171-050 HUMAN OTC DRUG STEBLANC WATER CC PACT 21 Light Beige Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 Coson Co., Ltd. OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE .91; .62; .26; 1.17; .26 g/13g; g/13g; g/13g; g/13g; g/13g 62171-060_5df2f2af-e89b-4a14-9813-dfb069575371 62171-060 HUMAN OTC DRUG STEBLANC WATER CC PACT 23 Natural Beige Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 Coson Co., Ltd. OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE .91; .62; .26; 1.17; .26 g/13g; g/13g; g/13g; g/13g; g/13g 62175-106_c91d7261-42cb-4cc5-8796-b9d6366e9a60 62175-106 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET ORAL 19930630 NDA AUTHORIZED GENERIC NDA020215 Kremers Urban Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 10 mg/1 62175-107_c91d7261-42cb-4cc5-8796-b9d6366e9a60 62175-107 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET ORAL 19930630 NDA AUTHORIZED GENERIC NDA020215 Kremers Urban Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 20 mg/1 62175-114_8cd25280-98e9-4feb-a5e4-7f797b2545f9 62175-114 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20030903 ANDA ANDA075410 Kremers Urban Pharmaceuticals Inc. OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 62175-118_8cd25280-98e9-4feb-a5e4-7f797b2545f9 62175-118 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20021104 ANDA ANDA075410 Kremers Urban Pharmaceuticals Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 62175-119_cea8a149-bbc8-4a53-8c4b-cbca09045a99 62175-119 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Kremers Urban Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 62175-123_6a6fb426-9ed2-4741-921b-2b8102b6ab29 62175-123 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin FILM, EXTENDED RELEASE TRANSDERMAL 20040810 ANDA ANDA075115 Kremers Urban Pharmaceuticals Inc. NITROGLYCERIN 20.8 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 62175-124_6a6fb426-9ed2-4741-921b-2b8102b6ab29 62175-124 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin FILM, EXTENDED RELEASE TRANSDERMAL 20040810 ANDA ANDA075115 Kremers Urban Pharmaceuticals Inc. NITROGLYCERIN 37.4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 62175-128_cea8a149-bbc8-4a53-8c4b-cbca09045a99 62175-128 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Kremers Urban Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 62175-129_cea8a149-bbc8-4a53-8c4b-cbca09045a99 62175-129 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Kremers Urban Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 120 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 62175-136_8cd25280-98e9-4feb-a5e4-7f797b2545f9 62175-136 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20090123 ANDA ANDA075410 Kremers Urban Pharmaceuticals Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 62175-151_5c3442ad-a515-4943-9762-64f99b26475e 62175-151 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030812 NDA AUTHORIZED GENERIC NDA021259 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 62175-152_5c3442ad-a515-4943-9762-64f99b26475e 62175-152 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030218 NDA AUTHORIZED GENERIC NDA021259 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 62175-153_5c3442ad-a515-4943-9762-64f99b26475e 62175-153 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030722 NDA AUTHORIZED GENERIC NDA021259 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 62175-154_5c3442ad-a515-4943-9762-64f99b26475e 62175-154 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20060321 NDA AUTHORIZED GENERIC NDA021259 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 62175-155_5c3442ad-a515-4943-9762-64f99b26475e 62175-155 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20060321 NDA AUTHORIZED GENERIC NDA021259 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 62175-156_5c3442ad-a515-4943-9762-64f99b26475e 62175-156 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20060321 NDA AUTHORIZED GENERIC NDA021259 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 60 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 62175-180_6d769972-1586-4ff9-bfaf-d9121425cd2c 62175-180 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 Kremers Urban Pharmaceuticals Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 62175-181_6d769972-1586-4ff9-bfaf-d9121425cd2c 62175-181 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 Kremers Urban Pharmaceuticals Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 62175-190_4e268f6d-be5c-4bd1-b384-2d0ce70e7e24 62175-190 HUMAN OTC DRUG GlycoLax Osmotic Laxative Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091006 ANDA ANDA090600 Kremers Urban Pharmaceuticals Inc. POLYETHYLENE GLYCOL 3350 17 g/17g 62175-195_2fb5d413-e4c6-4edb-afb3-683b60c32ef0 62175-195 HUMAN OTC DRUG Polyethylene Glycol 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091006 ANDA ANDA090600 Kremers Urban POLYETHYLENE GLYCOL 3350 17 g/17g 62175-204_8abdc718-a2d0-477d-b2de-4c58bbf340a4 62175-204 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA200405 Kremers Urban Pharmaceuticals Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 62175-205_8abdc718-a2d0-477d-b2de-4c58bbf340a4 62175-205 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA200405 Kremers Urban Pharmaceuticals Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 62175-210_8abdc718-a2d0-477d-b2de-4c58bbf340a4 62175-210 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA201522 Kremers Urban Pharmaceuticals Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 62175-260_668b889d-543e-49f7-afd0-05f038dffcaf 62175-260 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Kremers Urban Pharmaceuticals Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 62175-261_668b889d-543e-49f7-afd0-05f038dffcaf 62175-261 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Kremers Urban Pharmaceuticals Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 62175-262_668b889d-543e-49f7-afd0-05f038dffcaf 62175-262 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20071003 ANDA ANDA077410 Kremers Urban Pharmaceuticals Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 62175-270_87e1d2ba-d9e4-4a34-8976-438b046bbaa9 62175-270 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20090301 ANDA ANDA078503 Kremers Urban Pharmaceuticals Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 62175-271_87e1d2ba-d9e4-4a34-8976-438b046bbaa9 62175-271 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20090301 ANDA ANDA078503 Kremers Urban Pharmaceuticals Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 62175-272_87e1d2ba-d9e4-4a34-8976-438b046bbaa9 62175-272 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20090301 ANDA ANDA078503 Kremers Urban Pharmaceuticals Inc. OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 62175-302_5aeb1256-11e9-4c65-8e9b-dbf4c1cfb9ea 62175-302 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole Sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA090678 Kremers Urban Pharmaceuticals Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 62175-310_498b8ef1-0f1e-4ecf-b229-28d26edfb5f7 62175-310 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130710 ANDA ANDA091695 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 62175-311_498b8ef1-0f1e-4ecf-b229-28d26edfb5f7 62175-311 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130710 ANDA ANDA091695 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 62175-312_498b8ef1-0f1e-4ecf-b229-28d26edfb5f7 62175-312 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130923 ANDA ANDA091695 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 36 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 62175-313_498b8ef1-0f1e-4ecf-b229-28d26edfb5f7 62175-313 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130923 ANDA ANDA091695 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 54 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 62175-361_051c2183-7e60-4bf3-b342-09d940d7bd91 62175-361 HUMAN PRESCRIPTION DRUG Monoket isosorbide mononitrate TABLET ORAL 19930630 NDA NDA020215 Kremers Urban Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 62175-362_051c2183-7e60-4bf3-b342-09d940d7bd91 62175-362 HUMAN PRESCRIPTION DRUG Monoket isosorbide mononitrate TABLET ORAL 19930630 NDA NDA020215 Kremers Urban Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 62175-380_e2c81f90-47d2-8cc7-25ab-80175b4aab6a 62175-380 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE, GELATIN COATED ORAL 20121030 ANDA ANDA090802 Kremers Urban Pharmaceuticals Inc. TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 62175-381_e2c81f90-47d2-8cc7-25ab-80175b4aab6a 62175-381 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE, GELATIN COATED ORAL 20121030 ANDA ANDA090802 Kremers Urban Pharmaceuticals Inc. TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 62175-382_e2c81f90-47d2-8cc7-25ab-80175b4aab6a 62175-382 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE, GELATIN COATED ORAL 20121030 ANDA ANDA090802 Kremers Urban Pharmaceuticals Inc. TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 62175-442_88c8bb0f-3709-4508-947d-0755c7ec7647 62175-442 HUMAN PRESCRIPTION DRUG POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 POWDER ORAL 20111001 ANDA ANDA076652 Kremers Urban Pharmaceuticals Inc. POLYETHYLENE GLYCOL 3350 1 g/g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 62175-446_cd812ad9-6f77-4c30-b736-97ada7e29063 62175-446 HUMAN PRESCRIPTION DRUG PEG-3350 and Electrolytes POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE, and SODIUM SULFATE POWDER, FOR SOLUTION ORAL 19841026 NDA AUTHORIZED GENERIC NDA018983 Kremers Urban Pharmaceuticals Inc. POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE 240; 2.98; 6.72; 5.84; 22.72 g/4L; g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 62175-485_14f41d4d-56a1-4e45-8ba3-05a245901e94 62175-485 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 100 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62175-486_14f41d4d-56a1-4e45-8ba3-05a245901e94 62175-486 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 200 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62175-487_14f41d4d-56a1-4e45-8ba3-05a245901e94 62175-487 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62175-490_7b43f989-bbb6-4e32-b6af-53dcfb4f4e5b 62175-490 HUMAN PRESCRIPTION DRUG Hydrocodone Polistirex and Chlorpheniramine Polistirex Pennkinetic hydrocodone bitartrate and chlorpheniramine maleate SUSPENSION, EXTENDED RELEASE ORAL 19871231 NDA AUTHORIZED GENERIC NDA019111 Kremers Urban Pharmaceuticals Inc. CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE 8; 10 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CIII 62175-570_1c690044-55d4-4d3b-8abc-03a4573f4ee5 62175-570 HUMAN PRESCRIPTION DRUG VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 100 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62175-571_1c690044-55d4-4d3b-8abc-03a4573f4ee5 62175-571 HUMAN PRESCRIPTION DRUG VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 200 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62175-572_1c690044-55d4-4d3b-8abc-03a4573f4ee5 62175-572 HUMAN PRESCRIPTION DRUG VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62175-580_5046b9f1-f17c-4481-b9be-0bf29961bb68 62175-580 HUMAN PRESCRIPTION DRUG VERELAN verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62175-581_5046b9f1-f17c-4481-b9be-0bf29961bb68 62175-581 HUMAN PRESCRIPTION DRUG VERELAN verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62175-582_5046b9f1-f17c-4481-b9be-0bf29961bb68 62175-582 HUMAN PRESCRIPTION DRUG VERELAN verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62175-583_5046b9f1-f17c-4481-b9be-0bf29961bb68 62175-583 HUMAN PRESCRIPTION DRUG VERELAN verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62175-617_6d769972-1586-4ff9-bfaf-d9121425cd2c 62175-617 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 Kremers Urban Pharmaceuticals Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 62175-710_13fc4e17-f66a-4835-86d7-74ac6492f443 62175-710 HUMAN PRESCRIPTION DRUG Anastrozole anastrozole TABLET, FILM COATED ORAL 20110105 ANDA ANDA091331 Kremers Urban Pharmaceuticals Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 62175-888_a93bd784-b002-41bb-a5c4-9b2af88736b7 62175-888 HUMAN PRESCRIPTION DRUG Letrozole letrozole TABLET, FILM COATED ORAL 20110603 ANDA ANDA091098 Kremers Urban Pharmaceuticals Inc. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 62175-890_1d80a637-0938-4dcb-a700-b50a49fdeacf 62175-890 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 Kremers Urban Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 62175-891_1d80a637-0938-4dcb-a700-b50a49fdeacf 62175-891 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 Kremers Urban Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 62175-892_1d80a637-0938-4dcb-a700-b50a49fdeacf 62175-892 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 Kremers Urban Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 62175-897_1d80a637-0938-4dcb-a700-b50a49fdeacf 62175-897 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 Kremers Urban Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 62185-0001_a6936dd3-a2a3-499d-8f7c-dfab24fdbb8d 62185-0001 HUMAN OTC DRUG Emotional Eating Thyroidinum (suis), Cortisone aceticum, Anacardium orientale, Antimonium crudum, Ignatia amara, Natrum muriaticum, Staphysagria, Hydrocortisone (cortisol). LIQUID ORAL 20140311 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC ANTIMONY TRISULFIDE; CORTISONE ACETATE; DELPHINIUM STAPHISAGRIA SEED; HYDROCORTISONE; SEMECARPUS ANACARDIUM JUICE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; SUS SCROFA THYROID 15; 12; 18; 30; 15; 15; 15; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 62185-0002_0a943d63-3bce-4afb-8e04-7757c85ba958 62185-0002 HUMAN OTC DRUG Professional Weight Maintenance Asclepias vincetoxicum, Echinacea (Angustifolia), Hypothalamus (suis), Hepar suis, Kidney (suis), Methylcobalamin, Gambogia, Graphites, Nux vomica, LIQUID ORAL 20140414 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; GAMBOGE; GLUCAGON; GRAPHITE; INSULIN HUMAN; LACTIC ACID, L-; METHYLCOBALAMIN; PHYTOLACCA AMERICANA ROOT; PORK KIDNEY; PORK LIVER; PROTEUS VULGARIS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA HYPOTHALAMUS 30; 30; 6; 6; 12; 30; 12; 30; 30; 8; 12; 8; 8; 30; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 62185-0003_022d7b6b-09e4-45de-a13f-6e6eb552b30a 62185-0003 HUMAN OTC DRUG WLP40 Asclepias vincetoxicum, Echinacea (Angustifolia), Hypothalamus (suis), Brain (suis), Hepar suis, Kidney (suis), Methylcobalamin, Pancreas suis, LIQUID ORAL 20140408 UNAPPROVED HOMEOPATHIC Dr.Donna Resivo DC 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; APC-356433; APC-356434; CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GLUCAGON; GRAPHITE; INSULIN HUMAN; LACTIC ACID, L-; METHYLCOBALAMIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; PORK BRAIN; PORK KIDNEY; PORK LIVER; PROTEUS VULGARIS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PANCREAS; SUS SCROFA STOMACH 30; 30; 8; 8; 6; 6; 12; 12; 30; 12; 30; 30; 8; 12; 12; 8; 8; 8; 30; 12; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62185-0004_217bf656-2dda-4f9d-94ea-85f56a47bdf2 62185-0004 HUMAN OTC DRUG Sugar Cravings Cinnamic acid, Phloridzinum, Argentum nitricum, ATP (Adenosine triphosphate disodium), Beet sugar, Dextrose, D-ribose, Fructose, Grape sugar (syrup), LIQUID ORAL 20140410 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC ACER SACCHARUM SAP; ADENOSINE TRIPHOSPHATE DISODIUM; CINNAMIC ACID; CORTICOTROPIN; DEXTROSE; FRUCTOSE; LACTIC ACID, L-; LACTOSE; LYCOPODIUM CLAVATUM SPORE; MALVIN; PHLORIZIN; RIBOSE, D-; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE; SILVER NITRATE; SUCROSE 6; 6; 6; 8; 6; 6; 6; 6; 6; 15; 6; 6; 30; 30; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 62185-0005_c36efa2c-9c73-4c9f-b1df-a16581621e37 62185-0005 HUMAN OTC DRUG Chip Cravings Coumarinum, Quercetin, Rutin, Bamboo, Barley, Corn, Levant cotton, Flax seed, Millet, Milo, Oat, California poppy, Rice, Rye, Safflower, LIQUID ORAL 20140317 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC AMARANTH; AVENA SATIVA FLOWERING TOP; BAMBUSA VULGARIS LEAF; BARLEY; BROWN RICE; CORN; CORTICOTROPIN; COUMARIN; ELYMUS REPENS ROOT; ENTEROCOCCUS FAECALIS; ESCHSCHOLZIA CALIFORNICA; FLAX SEED; LACTIC ACID, L-; LEVANT COTTON SEED; MILLET; OAT; QUERCETIN; RUTIN; RYE; SAFFLOWER; SESAME SEED; SODIUM SULFATE; SORGHUM; SORGHUM BICOLOR WHOLE; SOYBEAN; SUGARCANE; SUNFLOWER SEED; WHEAT 6; 6; 9; 9; 9; 9; 8; 6; 6; 30; 9; 9; 6; 9; 9; 9; 6; 6; 9; 9; 9; 6; 9; 9; 9; 9; 9; 9 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62185-0006_821ef1ed-a7cf-4be5-902a-ac620c4f533a 62185-0006 HUMAN OTC DRUG Bread Cravings Acetaldehyde, Coumarinum, Histaminum hydrochloricum, Quercetin, Torula cerevisiae, Candida albicans, Candida parapsilosis, Adrenocorticotrophin, LIQUID ORAL 20140410 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC ACETALDEHYDE; ALCALIGENES FAECALIS; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; CORTICOTROPIN; COUMARIN; HISTAMINE DIHYDROCHLORIDE; LACTIC ACID, L-; QUERCETIN; SACCHAROMYCES CEREVISIAE; SEPIA OFFICINALIS JUICE 6; 30; 12; 12; 6; 6; 6; 6; 6; 10; 6 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; 1/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 62187-0001_584a3278-f922-460c-986b-6bcdea45e4e7 62187-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19950921 UNAPPROVED MEDICAL GAS Deborah Stubblefield dba Respiratory Services OXYGEN 99 L/100L 62191-004_63e98caf-8864-4efd-8b07-bb7279981d63 62191-004 HUMAN OTC DRUG Oi Lin Natural Sunscreen SPF 30 SUNSCREEN, TITANIUM DIOXIDE EMULSION TOPICAL 19900801 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. TITANIUM DIOXIDE .66 g/g 62191-007_98c5593a-c1f3-44bc-af6e-0f21fbbea81d 62191-007 HUMAN OTC DRUG Protective Foundation Sunscreen SPF 15 Sunscreen, AVOBENZONE, OCTINOXATE EMULSION TOPICAL 20020301 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. AVOBENZONE; OCTINOXATE .02; .06 g/g; g/g 62191-009_457351b7-b652-434b-bb1e-1729d641426c 62191-009 HUMAN OTC DRUG OI LIN DEEP MOISTURE SUNSCREEN SPF 25 SUNSCREEN, TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20090127 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. TITANIUM DIOXIDE; ZINC OXIDE 94; 39 mg/g; mg/g 62191-010_62fdd9f8-ed38-4140-8185-93d23928a19d 62191-010 HUMAN OTC DRUG OI LIN DEEP MOISTURE SUNSCREEN SPF 25 TINTED SUNSCREEN, TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20090127 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. TITANIUM DIOXIDE; ZINC OXIDE 94; 39 mg/g; mg/g 62191-012_86cf55d3-97bf-4f5d-ae4d-6ab178a9863d 62191-012 HUMAN OTC DRUG OI LIN SUNMILK SUNSCREEN SPF 25 SUNSCREEN, TITANIUM DIOXIDE EMULSION TOPICAL 20090423 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. TITANIUM DIOXIDE 85 mg/g 62192-8500_40f108d6-4c4d-4adb-983a-486692eb7dbd 62192-8500 HUMAN OTC DRUG Preboost benzocaine LIQUID TOPICAL 20140218 OTC MONOGRAPH FINAL part348 944 Corp BENZOCAINE 4 g/100mL 62206-2850_44d4060a-ea9c-4e04-b8b8-afbc72eabc18 62206-2850 HUMAN OTC DRUG Badger Diaper ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 10 g/100mL 62206-4603_c48974af-b26c-4a1c-9d43-631825a812d8 62206-4603 HUMAN OTC DRUG Badger Unscented SPF 15 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 10 g/100mL 62206-4654_47294823-9d08-4787-ab13-e340beb45854 62206-4654 HUMAN OTC DRUG Badger SPF 15 Sunscreen Lip Balm ZINC OXIDE STICK TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 8 g/100g 62206-4703_25d4645a-680a-4d67-b9d2-c85ba3c6ec50 62206-4703 HUMAN OTC DRUG Badger Lavender SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 18.75 g/100mL 62206-4720_c276a9a9-03ba-4d35-bcf3-bca54553790a 62206-4720 HUMAN OTC DRUG Badger SPF 35 All Season Face ZINC OXIDE STICK TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 22.5 g/100g 62206-4721_467b0b21-efa0-4d49-84df-39e638195273 62206-4721 HUMAN OTC DRUG Badger SPF 35 Kids All Season ZINC OXIDE STICK TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 22.5 g/100g 62206-4730_16014d6e-c38f-4624-bc56-49ff08d4df38 62206-4730 HUMAN OTC DRUG Badger SPF 34 Anti-Bug Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 20 g/100mL 62206-4740_aeb9e87d-dd51-44c3-a761-39eedec7c75a 62206-4740 HUMAN OTC DRUG Badger Unscented SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 18.75 g/100mL 62206-4741_06fb3533-0d73-49bc-9f93-816ec6092cb3 62206-4741 HUMAN OTC DRUG Badger Tinted Unscented SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 18.75 g/100mL 62206-4750_e66e4d79-ad76-41b2-b85c-53e764af3c89 62206-4750 HUMAN OTC DRUG Badger Baby SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 18.75 g/100mL 62206-4760_a5a52901-8cfa-4d48-8cd0-60c131ed1c9c 62206-4760 HUMAN OTC DRUG Badger Sport SPF 35 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 22.5 g/100mL 62206-4780_bf9b0416-5703-417f-aac6-5f4b481fa89b 62206-4780 HUMAN OTC DRUG Badger Kids SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 18.75 g/100mL 62206-4901_abebed97-8a67-4cad-8abb-2d9411f7515e 62206-4901 HUMAN OTC DRUG Badger Damascus Rose Broad Spectrum SPF 20 Face Sunscreen ZINC OXIDE LOTION TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 12 g/100mL 62206-4902_5afff6a9-82fa-4ec5-8604-4b9ec7f5565e 62206-4902 HUMAN OTC DRUG Badger Damascus Rose Broad Spectrum SPF 20 Face Sunscreen - Sheer Tint ZINC OXIDE LOTION TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 12 g/100mL 62207-365_d34dfb34-22bd-45ff-b175-b9b4af09aa6a 62207-365 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110101 ANDA ANDA079174 Granules India Limited IBUPROFEN 200 mg/1 62207-366_d34dfb34-22bd-45ff-b175-b9b4af09aa6a 62207-366 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110101 ANDA ANDA079174 Granules India Limited IBUPROFEN 200 mg/1 62207-750_fea7ea82-2d26-426c-a529-23861bc638ec 62207-750 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20110930 ANDA ANDA091353 Granules India Limited NAPROXEN SODIUM 220 mg/1 62207-753_fea7ea82-2d26-426c-a529-23861bc638ec 62207-753 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20110930 ANDA ANDA091353 Granules India Limited NAPROXEN SODIUM 220 mg/1 62209-9266_843ead7f-6cf7-47da-8d8b-eba5d035bc37 62209-9266 HUMAN OTC DRUG Huo Pao Tieh Ta Feng Shin Kao L-Menthol, Camphor PLASTER TOPICAL 20130906 OTC MONOGRAPH NOT FINAL part348 Dah Wei Biochemical Pharmaceutic International Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL 40; 200 mg/5g; mg/5g 62211-010_2e2e7b0c-f124-430d-a592-e1d13b203117 62211-010 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20090814 OTC MONOGRAPH NOT FINAL part343 A&Z Pharmaceutical, Inc. ACETAMINOPHEN 325 mg/1 62211-011_f188c3d6-c7aa-4e08-89e5-9c3f9b61227f 62211-011 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20040316 OTC MONOGRAPH NOT FINAL part343 A&Z Pharmaceutical, Inc. ACETAMINOPHEN 500 mg/1 62211-012_e7fa7bfc-55e4-495d-95d2-fac45c9aa841 62211-012 HUMAN OTC DRUG Pain Relief ES Acetaminophen TABLET ORAL 20140610 OTC MONOGRAPH NOT FINAL part343 A&Z Pharmaceutical, Inc. ACETAMINOPHEN 500 mg/1 62211-023_276769c2-2ab6-4380-a54c-3699e1d41ac2 62211-023 HUMAN OTC DRUG Children Acetaminophen Children Acetaminophen TABLET, CHEWABLE ORAL 20030310 OTC MONOGRAPH NOT FINAL part343 A&Z Pharmaceutical, Inc. ACETAMINOPHEN 80 mg/1 62211-029_60c6fd3b-80a3-475f-ae95-b93467b21f18 62211-029 HUMAN OTC DRUG Tension Headache Relief Tension Headache Relief CAPSULE ORAL 20140910 OTC MONOGRAPH NOT FINAL part343 A&Z Pharmaceutical, Inc. ACETAMINOPHEN; CAFFEINE 500; 65 ug/1; mg/1 62211-046_17ae651c-b552-4fef-a3cc-d62598d051a8 62211-046 HUMAN OTC DRUG Bismuth Subsalicylate Bismuth Subsalicylate TABLET, CHEWABLE ORAL 20030310 OTC MONOGRAPH FINAL part335 A&Z Pharmaceutical, Inc. BISMUTH SUBSALICYLATE 262 mg/1 62211-048_9ee96942-020f-4a1d-9123-622d62652136 62211-048 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl TABLET, COATED ORAL 20030310 OTC MONOGRAPH NOT FINAL part343 A&Z Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 62211-070_4420c82c-32ca-436f-b678-f1189c9eb983 62211-070 HUMAN OTC DRUG Simethicone Cherry Flavored Chewable Simethicone Cherry Flavored Chewable TABLET, CHEWABLE ORAL 20030310 OTC MONOGRAPH FINAL part332 A&Z Pharmaceutical, Inc. DIMETHICONE 80 mg/1 62211-127_d3bc1582-be9b-4a30-ba01-587132319b44 62211-127 HUMAN OTC DRUG D-Cal SoyCal calcium carbonate and soy isoflavones and vitamin D3 TABLET ORAL 20100122 OTC MONOGRAPH FINAL part331 A&Z Pharmaceutical, Inc. CALCIUM CARBONATE; CHOLECALCIFEROL; SOY ISOFLAVONES 28.32; 480; 1 g/1; ug/1; g/1 62211-165_6b216230-7532-4922-b206-9663e33e5f67 62211-165 HUMAN OTC DRUG Children Acetaminophen Grape Flavored Chewable Acetaminophen TABLET, CHEWABLE ORAL 20030310 OTC MONOGRAPH NOT FINAL part343 A&Z Pharmaceutical, Inc. ACETAMINOPHEN 80 mg/1 62211-166_c4c180cf-1acc-4a8e-b296-efdcb46c51f7 62211-166 HUMAN OTC DRUG D-CAL calcium carbonate TABLET, CHEWABLE ORAL 19970917 OTC MONOGRAPH FINAL part331 A&Z Pharmaceutical Inc. CALCIUM CARBONATE 750 mg/1 62211-174_debb6590-0a33-4ba1-be0e-2d744738af8d 62211-174 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20031203 OTC MONOGRAPH FINAL part331 A&Z Pharmaceutical, Inc. MAGNESIUM OXIDE 400 mg/1 62211-196_afc32948-04d2-4f9b-8efe-ee41013aa373 62211-196 HUMAN OTC DRUG D-Cal Kids Calcium Carbonate TABLET, CHEWABLE ORAL 19970917 OTC MONOGRAPH FINAL part331 A&Z Pharmaceutical, Inc. CALCIUM CARBONATE 750 mg/1 62211-219_33376895-edf5-4dde-8614-b9798e97b9ed 62211-219 HUMAN OTC DRUG Calcium Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20131205 OTC MONOGRAPH FINAL part331 A&Z Pharmaceutical, Inc. CALCIUM CARBONATE 500 mg/1 62211-220_45871422-26c9-4cf4-8bb4-e2963e6d4146 62211-220 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20091103 OTC MONOGRAPH FINAL part343 A&Z Pharmaceutical, Inc. ASPIRIN 81 mg/1 62211-225_05b57e0c-508e-4767-9e40-4749b0c764a2 62211-225 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20091103 OTC MONOGRAPH FINAL part343 A&Z Pharmaceutical, Inc. ASPIRIN 325 mg/1 62211-229_7fb55e64-4fb4-4923-b209-67dce69176ca 62211-229 HUMAN OTC DRUG Calcium Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20131205 OTC MONOGRAPH FINAL part331 A&Z Pharmaceutical, Inc. CALCIUM CARBONATE 750 mg/1 62211-239_e87949f0-a237-4945-8773-75f97914621a 62211-239 HUMAN OTC DRUG D-Cal Kids Calcium Carbonate GRANULE ORAL 20080104 OTC MONOGRAPH FINAL part331 A&Z Pharmaceutical, Inc. CALCIUM CARBONATE 750 mg/g 62211-246_1e1c45b1-06e7-4e69-9932-17663d79fef7 62211-246 HUMAN OTC DRUG Chlorpheniramine maleate Chlorpheniramine maleate TABLET ORAL 20100212 OTC MONOGRAPH FINAL part341 A&Z Pharmaceutical, Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 62211-261_d4316094-6dae-4944-8ae6-a22a7f54e70c 62211-261 HUMAN OTC DRUG Acetaminophen Phenylephrine HCl Acetaminophen 500mg Phenylephrine HCl 5mg TABLET ORAL 20140916 OTC MONOGRAPH NOT FINAL part343 A&Z Pharmaceutical, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 62211-267_89f5a830-2d57-4238-b88f-2bb73af8240e 62211-267 HUMAN OTC DRUG Bioelectro Night Acetaminophen and Diphenhydramine HCI TABLET ORAL 20100930 OTC MONOGRAPH FINAL part336 A&Z Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 62211-267_bc17640c-78e0-47d0-8b5c-7d6338b6d181 62211-267 HUMAN OTC DRUG Pain Relief PM acetaminophen and diphenhydramine hydrochloride TABLET, COATED ORAL 20040220 OTC MONOGRAPH NOT FINAL part343 A&Z Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 62211-272_6046a85f-19e6-4d7f-b0bf-89897276f8ab 62211-272 HUMAN OTC DRUG Phenylephrine HCl Phenylephrine HCl TABLET ORAL 20091103 OTC MONOGRAPH FINAL part341 A&Z Pharmaceutical, Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 62211-275_eb05938c-809a-4ff9-a4a8-3bb5d550fa04 62211-275 HUMAN OTC DRUG XL-3 Cold Medicine Acetaminophen and Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20140911 OTC MONOGRAPH FINAL part341 A&Z Pharmaceutical, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 62211-285_1f947edc-a977-4353-a9ed-956a3d55f59c 62211-285 HUMAN OTC DRUG BioElectro Day Acetaminophen and Aspirin and Caffeine TABLET ORAL 20050518 OTC MONOGRAPH NOT FINAL part343 A&Z Pharmaceutical, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 62211-309_f6eba2c6-7a53-4520-bbae-e5d0b4234f93 62211-309 HUMAN OTC DRUG Allergy Relief Loratadine 10 mg TABLET ORAL 20131205 ANDA ANDA019658 A&Z Pharmaceutical, Inc LORATADINE 10 mg/1 62211-312_4b10cb66-7990-4e67-b726-3f6409c7e601 62211-312 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20070608 OTC MONOGRAPH FINAL part343 A&Z Pharmaceutical, Inc. ASPIRIN 325 mg/1 62211-314_5cbac076-0fa4-4eae-83b7-6c71b7f5d1fd 62211-314 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20100915 OTC MONOGRAPH FINAL part334 A&Z Pharmaceutical, Inc. DOCUSATE SODIUM 100 mg/1 62211-333_8fe6d92e-7c20-4fc5-b3d9-bcb255ac860a 62211-333 HUMAN OTC DRUG Acetaminophen Phenylephrine HCl Acetaminophen 500mg Phenylephrine HCl 5mg TABLET ORAL 20141203 OTC MONOGRAPH NOT FINAL part343 A7Z Pharmaceutical, Inc. ACETAMINOPHEN 325 mg/1 62211-335_d40d1813-9f2f-4e0c-b7eb-2532cebc5d8e 62211-335 HUMAN OTC DRUG Ibuprofen (NSAID) Pain Reliever/Fever Reducer Ibuprofen TABLET ORAL 20110430 OTC MONOGRAPH NOT FINAL part343 A&Z Pharmaceutical, Inc. IBUPROFEN 200 mg/1 62211-338_d40d1813-9f2f-4e0c-b7eb-2532cebc5d8e 62211-338 HUMAN OTC DRUG Ibuprofen (NSAID) Pain Reliever/Fever Reducer Ibuprofen CAPSULE ORAL 20110430 OTC MONOGRAPH NOT FINAL part343 A&Z Pharmaceutical, Inc. IBUPROFEN 200 mg/1 62211-339_487ebb57-c1e7-4ac8-834b-868d961b89a2 62211-339 HUMAN OTC DRUG Daytime Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI CAPSULE, LIQUID FILLED ORAL 20110609 OTC MONOGRAPH FINAL part341 A&Z Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 62211-340_6251afbd-7314-446c-843c-f35e035e9f49 62211-340 HUMAN OTC DRUG Nighttime Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20110325 OTC MONOGRAPH NOT FINAL part343 A&Z Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 62211-345_0f79670a-a8b3-4014-86d9-8457fba7bca6 62211-345 HUMAN OTC DRUG Mucus Relief DM Dextromehtorphan HBr / Guaifenesin TABLET ORAL 20140821 OTC MONOGRAPH FINAL part341 A&Z Pharmaceutical, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 62211-350_4a144ecb-df2e-430d-844b-9fd02e3108d3 62211-350 HUMAN OTC DRUG Allergy Relief Cetirizine HCl 10 mg TABLET ORAL 20131210 ANDA ANDA078317 A&Z Pharmaceutical, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 62211-838_91cfadbe-8fca-499f-a029-ec486c1d2412 62211-838 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20130919 OTC MONOGRAPH FINAL part343 A&Z Pharmaceutical Inc. ASPIRIN 81 mg/1 62211-839_ce60796c-4a74-482b-b345-2053f682c81c 62211-839 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20131126 OTC MONOGRAPH FINAL part343 A&Z Pharmaceutical, Inc. ASPIRIN 325 mg/1 62212-252_6b58ac3b-8073-4675-81d6-4445b2b60b79 62212-252 HUMAN OTC DRUG Menthol Amish Origins Medicated CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Amish Origins LLC MENTHOL 8 g/100g 62217-152_e7f02de2-e352-45ee-9136-5b21952326d6 62217-152 HUMAN OTC DRUG Presidents Choice Octinoxate, Homosalate, Oxybenzone, Avobenzone LOTION TOPICAL 20050330 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYBENZONE 2; 5; 7.5; 4 g/100g; g/100g; g/100g; g/100g 62217-174_bdfdee07-a75e-4c06-9692-bb3ff6e2d980 62217-174 HUMAN OTC DRUG Fruit of the Earth Block Up Broad Spectrum Baby SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20140826 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 90; 75; 50; 15; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 62217-200_fb436d66-d272-4699-a3b1-48b864db66b3 62217-200 HUMAN OTC DRUG Fruit of the Earth Aloe Vera Cool Blue Lidocaine Hydrochloride GEL TOPICAL 20140910 OTC MONOGRAPH NOT FINAL part348 Fruit of the Earth, Inc. LIDOCAINE 10 mg/g 62217-201_8c217e0d-1969-4b2a-a0ad-07c71c951c9a 62217-201 HUMAN OTC DRUG Fruit of the Earth Cool Blue Aloe Mist Continuous Lidocaine Hydrochloride SPRAY TOPICAL 20140912 OTC MONOGRAPH NOT FINAL part348 Fruit of the Earth, Inc. LIDOCAINE 10 mg/mL 62221-935_269c3e27-875a-40ab-87d6-bbd33012f25e 62221-935 HUMAN OTC DRUG Sonacaine Topical Anesthetic With Menthol LIDOCAINE GEL TOPICAL 20120502 OTC MONOGRAPH FINAL part348 Filltech USA, LLC LIDOCAINE 4 g/100g 62223-001_4c98910a-e0ae-4bae-a8f5-ba385ce85c4b 62223-001 HUMAN OTC DRUG Preference Hand Sanitizer Alcohol SPRAY TOPICAL 20140614 OTC MONOGRAPH NOT FINAL part333A Whip Mix Corporation ALCOHOL 340.56 mL/470mL 62225-600_0518db56-7c76-3ffe-e054-00144ff8d46c 62225-600 HUMAN PRESCRIPTION DRUG Omidria phenylephrine and ketorolac INJECTION, SOLUTION, CONCENTRATE INTRAOCULAR 20140613 NDA NDA205388 Omeros Corporation KETOROLAC; PHENYLEPHRINE 2.88; 10.16 mg/mL; mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 62242-010_f90efcb7-86bf-4126-8de3-f4de8e6b3157 62242-010 HUMAN OTC DRUG SUPREME SKINPIA 10 SUN BLOCK Octinoxate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20140102 OTC MONOGRAPH NOT FINAL part352 EBAIN Corporation Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.5; 1.5; 1.5 mg/50mL; mg/50mL; mg/50mL 62242-020_9dcf88b4-206c-4157-9674-9ee58e639748 62242-020 HUMAN OTC DRUG SUPREME SKINPIA 10 BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140102 OTC MONOGRAPH NOT FINAL part352 EBAIN Corporation Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 5; .3 mg/50mL; mg/50mL 62242-030_d982dc0d-0038-4df8-ba46-6c00dae8ba3f 62242-030 HUMAN OTC DRUG SKINPIA 10 SKIN SHIELD RENEWAL Dimethicone CREAM TOPICAL 20140102 OTC MONOGRAPH FINAL part347 EBAIN Corporation Co., Ltd. DIMETHICONE .5 mg/50mL 62250-103_217d6f0b-3c87-4686-80aa-7f9017b52d67 62250-103 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140808 NDA NDA205029 Belcher Pharmaceuticals, LLC EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 62250-619_bad81e16-92c0-40a7-af85-fdd0c3a581f7 62250-619 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET ORAL 20120515 ANDA ANDA078355 Belcher Pharmaceuticals,LLC DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 62250-801_78fed700-ee01-4f66-a8e2-46708797d525 62250-801 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110615 ANDA ANDA062713 Belcher Pharmaceuticals, LLC CEPHALEXIN 250 mg/1 62250-802_78fed700-ee01-4f66-a8e2-46708797d525 62250-802 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110615 ANDA ANDA062713 Belcher Pharmaceuticals, LLC CEPHALEXIN 500 mg/1 62257-012_53e30cc3-4653-427c-9564-a2b89b381a0f 62257-012 HUMAN OTC DRUG 1012 Antimicrobial CHLOROXYLENOL SOAP TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. CHLOROXYLENOL 3 mg/mL 62257-014_e3f8a26b-2a48-45ee-9557-0cc750634a5d 62257-014 HUMAN OTC DRUG 1014 Foaming Antimicrobial TRICLOSAN SOAP TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. TRICLOSAN .003 mg/mL 62257-160_cd68b297-8b56-469c-9f73-075338427fad 62257-160 HUMAN OTC DRUG Lynx Antibacterial CHLOROXYLENOL SOAP TOPICAL 20060714 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. CHLOROXYLENOL 3 mg/mL 62257-221_aea401ec-46a3-40a8-ad1a-b44ae050a640 62257-221 HUMAN OTC DRUG Hand-Aid ALCOHOL GEL TOPICAL 20001218 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .7 mL/mL 62257-363_febeb5b5-e67c-4775-b501-5476ea0d2d47 62257-363 HUMAN OTC DRUG Cleanse CHLOROXYLENOL SOAP TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. CHLOROXYLENOL 3 mg/mL 62257-364_674d7418-dbd9-4262-97de-4dd6bc3b82dc 62257-364 HUMAN OTC DRUG Prevens TRICLOSAN SOAP TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. TRICLOSAN .003 mL/mL 62257-365_133da4be-b4a0-433f-8b90-de9d6f7b6ec1 62257-365 HUMAN OTC DRUG Sani-Silk ALCOHOL LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .7 mL/mL 62257-366_068dc902-0e24-4026-8b25-607a1e66113f 62257-366 HUMAN OTC DRUG Jade MENTHOL SOAP TOPICAL 20100801 UNAPPROVED DRUG OTHER ABC Compounding Co., Inc. MENTHOL 4 mg/mL 62257-367_9639e347-8a55-427d-b4c0-10d355523de0 62257-367 HUMAN OTC DRUG Coral TRICLOSAN SOAP TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. TRICLOSAN .003 mL/mL 62257-369_1fc9deff-6065-4a49-85ee-ffe30e039a09 62257-369 HUMAN OTC DRUG Clean All ALCOHOL LIQUID TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .7 mL/mL 62257-370_2ae6d037-a1ee-43dc-9838-152696a87d63 62257-370 HUMAN OTC DRUG Clean BENZETHONIUM CHLORIDE LIQUID TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. BENZETHONIUM CHLORIDE 2 mg/mL 62257-512_945b7ec7-8cbd-4def-b49a-4da40c868b96 62257-512 HUMAN OTC DRUG Handy Quat BENZALKONIUM CHLORIDE SOAP TOPICAL 19950515 OTC MONOGRAPH NOT FINAL part333 ABC Compounding Co., Inc. BENZALKONIUM CHLORIDE; N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14) 12.5; 12.5 mg/mL; mg/mL 62257-544_65af7578-814e-4f47-8da6-666f05ea4fd7 62257-544 HUMAN OTC DRUG Palm CHLOROXYLENOL SOAP TOPICAL 19981221 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. CHLOROXYLENOL 3 mg/mL 62257-575_c62e150a-15d7-4f8d-b58f-cf7f270f58a4 62257-575 HUMAN OTC DRUG QS Plus BENZETHONIUM CHLORIDE LIQUID TOPICAL 20030630 OTC MONOGRAPH NOT FINAL part333 ABC Compounding Co., Inc. BENZETHONIUM CHLORIDE 2 mg/mL 62257-576_c56831b4-2584-4aca-86b4-e1bb034c94f5 62257-576 HUMAN OTC DRUG Foamy Mango TRICLOSAN SOAP TOPICAL 20030703 OTC MONOGRAPH NOT FINAL part333 ABC Compounding Co., Inc. TRICLOSAN .003 mL/mL 62257-585_2b2fe544-a9d9-4471-9a9e-61c9f2a642ba 62257-585 HUMAN OTC DRUG Fast ALCOHOL LIQUID TOPICAL 20071220 OTC MONOGRAPH NOT FINAL part333 ABC Compounding Co., Inc. ALCOHOL .7 mL/mL 62257-605_ed5ca57e-c210-4833-9369-32f76995404f 62257-605 HUMAN OTC DRUG Alcogel ALCOHOL GEL TOPICAL 20070427 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .7 mL/mL 62257-606_5a93284c-3db0-438b-8c47-979c3c0d5460 62257-606 HUMAN OTC DRUG Hand-E XL ALCOHOL GEL TOPICAL 20050401 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .7 mL/mL 62257-607_00451f0a-813b-477b-886c-93746029d5da 62257-607 HUMAN OTC DRUG Hand Sanitizer ALCOHOL GEL TOPICAL 20060714 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .7 mL/mL 62257-639_7e92a011-2402-4dbf-8021-ea8f77537354 62257-639 HUMAN OTC DRUG Clean All ALCOHOL LIQUID TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .62 mL/mL 62257-738_2df3c152-e659-4295-9c7e-7e123ab0070a 62257-738 HUMAN OTC DRUG Sani-Spritz ALCOHOL LIQUID TOPICAL 20091031 OTC MONOGRAPH NOT FINAL part333 ABC Compounding Co., Inc. ALCOHOL .7 mL/mL 62257-770_c7b146c0-c19e-4420-81ab-de6a54c0f39c 62257-770 HUMAN OTC DRUG Antibacterial CHLOROXYLENOL SOAP TOPICAL 20140409 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. CHLOROXYLENOL 3 mg/mL 62257-773_90e3f8eb-e736-4923-b2cd-d884ead724bf 62257-773 HUMAN OTC DRUG MediSoft ALCOHOL AEROSOL, FOAM TOPICAL 20090831 OTC MONOGRAPH NOT FINAL part333 ABC Compounding Co., Inc. ALCOHOL 620 mg/g 62257-783_b4c5512f-bfbc-44c6-8944-409eed07be13 62257-783 HUMAN OTC DRUG Hand Sanitizing Wipes ALCOHOL CLOTH TOPICAL 20090409 OTC MONOGRAPH NOT FINAL part333 ABC Compounding Co., Inc. ALCOHOL 620 mg/g 62257-785_c6c49637-65eb-45f9-b867-85d048f5da52 62257-785 HUMAN OTC DRUG QS Plus Hand Sanitizing Wipes BENZETHONIUM CHLORIDE CLOTH TOPICAL 20090409 OTC MONOGRAPH NOT FINAL part333 ABC Compounding Co., Inc. BENZETHONIUM CHLORIDE 2 mg/g 62257-855_c0c1dbfd-4ec2-4fea-86cd-ae6314501194 62257-855 HUMAN OTC DRUG Fast ALCOHOL LIQUID TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .62 mL/mL 62257-856_1723bd32-7ee9-4788-a442-9f6b6b1672df 62257-856 HUMAN OTC DRUG Mousse Vite ALCOHOL LIQUID TOPICAL 20071220 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .62 mL/mL 62257-938_1012ed5e-47c5-4b75-9467-8ec4b5a16f28 62257-938 HUMAN OTC DRUG SoftSan ALCOHOL LOTION TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .7 mL/mL 62257-950_35b8d32f-4ac5-42ce-afc2-28b1ad4a91b1 62257-950 HUMAN OTC DRUG Clear Choice Out of Sight CHLOROXYLENOL SOAP TOPICAL 20140409 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. CHLOROXYLENOL 3 mg/mL 62266-3245_9f4729ae-cbc1-44e8-9637-75f2bf9c3a70 62266-3245 HUMAN OTC DRUG Ho Liang Kee Camphor, Menthol OIL TOPICAL 20130223 OTC MONOGRAPH NOT FINAL part348 Changshu Starsea Pharmaceutical Co., Ltd. CAMPHOR OIL; MENTHOL 4.7; 10 g/100g; g/100g 62273-001_745ddc70-b056-4e91-afb5-79d8bf3a694a 62273-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19800101 NDA NDA205849 Metro Welding Supply Corporation OXYGEN 995 mL/L 62273-002_448387c4-6c79-4ed8-af37-98df7cb62112 62273-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20120301 UNAPPROVED MEDICAL GAS Metro Welding Supply Corporation NITROGEN 995 mL/L 62273-003_50085439-4f7b-4bd0-83fc-afbe620b0ae3 62273-003 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20120301 UNAPPROVED MEDICAL GAS Metro Welding Supply Corporation AIR 1000 mL/L 62295-3014_aeba126b-1f54-4194-a252-02af3fad4e97 62295-3014 HUMAN PRESCRIPTION DRUG Betamethasone Combo 7mg/mL Betamethasone Acetate and Betamethasone Sodium Phosphate 7mg/mL INJECTION, SUSPENSION INTRAMUSCULAR 20131220 UNAPPROVED DRUG OTHER US Compounding, Inc BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE 3; 4 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 62295-3016_d7d771f7-280d-4fb5-a0a2-83638acfc7df 62295-3016 HUMAN PRESCRIPTION DRUG Betamethasone SP 24mg/2mL PF Betamethasone Sodium Phosphate 12mg/mL Preservative Free INJECTION, SOLUTION EPIDURAL; INTRAMUSCULAR; INTRASPINAL; INTRATHECAL 20131220 UNAPPROVED DRUG OTHER US Compounding, Inc BETAMETHASONE SODIUM PHOSPHATE 12 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 62295-3018_05fa8bc6-c5ea-48a7-b871-c4eb17149594 62295-3018 HUMAN PRESCRIPTION DRUG Betamethasone Combo 6mg/mL PF Betamethasone Acetate and Betamethasone Sodium Phosphate 6mg/mL Preservative Free INJECTION, SUSPENSION EPIDURAL; INTRAMUSCULAR; INTRASPINAL; INTRATHECAL 20131220 UNAPPROVED DRUG OTHER US Compounding, Inc BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE 3; 3 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 62295-3249_ccd5b0ba-666c-4e3a-9fa1-53f4733e1f8c 62295-3249 HUMAN PRESCRIPTION DRUG Hyaluronic Acid 60mg and Lidocaine 2% PF Hyaluronic Acid 20mg/mL with Lidocaine 2% Preservative Free - 3mL Syringe INJECTION, SOLUTION INTRA-ARTICULAR 20131220 UNAPPROVED DRUG OTHER US Compounding, Inc HYALURONIC ACID; LIDOCAINE HYDROCHLORIDE 20; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 62296-0021_52a4863c-8193-45e0-b673-7c02f6ee1f05 62296-0021 HUMAN OTC DRUG Ulta Vanilla Sugar Anti-Bacterial Gentle Foaming Triclosan LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN .3 g/100g 62296-0022_08e02b86-964b-43f7-84c0-8922b83ce7d3 62296-0022 HUMAN OTC DRUG Ulta Mandarin Mint Anti-Bacterial Gentle Foaming Triclosan LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN .3 g/100g 62296-0023_98db7d18-717c-48d1-aa82-c9cd0f52bb66 62296-0023 HUMAN OTC DRUG Ulta Sparkling Lemon Anti-Bacterial Gentle Foaming Triclosan LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN .3 g/100g 62296-0024_b93f7408-96e6-4aba-9266-49d5c2bb7073 62296-0024 HUMAN OTC DRUG Ulta Pomegranate Lime Anti-Bacterial Gentle Foaming Triclosan LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN .3 g/100g 62296-0025_b70f1886-663a-4cd8-ad9b-97216d453061 62296-0025 HUMAN OTC DRUG Ulta Freshwater Mist Anti-Bacterial Gentle Foaming Triclosan LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN .3 g/100g 62296-0026_6322d206-cb38-4347-aa52-fbae69aae9f6 62296-0026 HUMAN OTC DRUG Ulta Lavender Woods Anti-Bacterial Gentle Foaming Triclosan LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN .3 g/100g 62296-0027_f1e1222e-bae3-44e5-a7e6-8acdc45e2161 62296-0027 HUMAN OTC DRUG Ulta Nectarine Spice Anti-Bacterial Gentle Foaming Triclosan LIQUID TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN .3 g/100g 62296-0030_a923d571-9232-4e95-9aec-64cdf4c075fc 62296-0030 HUMAN OTC DRUG Ulta Vanilla Sugar Anti-Bacterial Deep Cleansing Triclosan LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN .3 g/100g 62296-0031_16a916de-1fa8-4e39-b661-73a1acf17fef 62296-0031 HUMAN OTC DRUG Ulta Sparkling Lemon Anti-Bacterial Deep Cleansing Triclosan LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN .3 g/100g 62296-0032_866c5302-6911-4d60-a0e4-c0e0dd661fd1 62296-0032 HUMAN OTC DRUG Ulta Freshwater Mist Anti-Bacterial Deep Cleansing Triclosan LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN .3 g/100g 62296-0033_e05fe010-fef5-4cb8-a3e8-db72f6751df9 62296-0033 HUMAN OTC DRUG Ulta Mandarin Mint Anti-Bacterial Deep Cleansing Triclosan LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN .3 g/100g 62296-0034_168c5e24-8bec-4ae9-b66c-ae25574340e5 62296-0034 HUMAN OTC DRUG Ulta Lavender Woods Anti-Bacterial Deep Cleansing Triclosan LIQUID TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN .3 g/100g 62296-0035_d60437b8-5c50-42f6-a3d8-352927a6df1b 62296-0035 HUMAN OTC DRUG Ulta Pomegranate Lime Anti-Bacterial Deep Cleansing Triclosan LIQUID TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN .3 g/100g 62296-0036_6793b5a1-55a9-4066-a9a0-477d7d4514d6 62296-0036 HUMAN OTC DRUG Ulta Nectarine Spice Anti-Bacterial Deep Cleansing Triclosan LIQUID TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN .3 g/100g 62296-0038_67b5c659-e04b-45c5-8eb8-b635e40925d4 62296-0038 HUMAN OTC DRUG Ulta Red Raspberry Anti-Bacterial Deep Cleansing Triclosan LIQUID TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN .3 g/100g 62296-0039_8991369b-a3a3-423c-b2bd-c00cecdb3f4f 62296-0039 HUMAN OTC DRUG Ulta Fresh Spice Anti-Bacterial Deep Cleansing Triclosan LIQUID TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN .3 g/100g 62296-0040_652c968a-06d4-43f1-bd6d-3db85d0a524d 62296-0040 HUMAN OTC DRUG Ulta Sparkling Lemon Anti-Bacterial Hand Sanitizer Alcohol GEL TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta ALCOHOL 68 mL/100mL 62296-0041_d5f636c2-bc63-4516-beb0-5fe239c261fa 62296-0041 HUMAN OTC DRUG Ulta Vanilla Sugar Anti-Bacterial Hand Sanitizer Alcohol GEL TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta ALCOHOL 68 mL/100mL 62296-0042_d7f74976-b23f-46b7-ac1d-9b3193211bae 62296-0042 HUMAN OTC DRUG Ulta Freshwater Mist Anti-Bacterial Hand Sanitizer Alcohol GEL TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta ALCOHOL 68 mL/100mL 62296-0043_60474747-f7e2-436c-adc0-9763f9bc2727 62296-0043 HUMAN OTC DRUG Ulta Mandarin Mint Anti-Bacterial Hand Sanitizer Alcohol GEL TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta ALCOHOL 68 mL/100mL 62296-0044_77d3bb35-6ff3-47a2-a1ec-c6d827142709 62296-0044 HUMAN OTC DRUG Ulta Pomegranate Lime Anti-Bacterial Hand Sanitizer Alcohol GEL TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta ALCOHOL 68 mL/100mL 62296-0045_5b0dd7bd-4679-45c2-ab5d-95ae0433ff8a 62296-0045 HUMAN OTC DRUG Ulta Lavender Woods Anti-Bacterial Hand Sanitizer Alcohol GEL TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta ALCOHOL 68 mL/100mL 62296-0051_376d0b77-9e18-4f5b-9bf2-d2be4482d1a3 62296-0051 HUMAN OTC DRUG Ulta Sparkling Lemon Anti-Bacterial Deep Cleansing Triclosan LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part333E Ulta TRICLOSAN 300 mg/100mL 62307-251_56eaf833-06b8-4258-a045-2bbc7a006ce4 62307-251 HUMAN OTC DRUG S4 Sunscreen Stick SPF30 Titanium Dioxide, Zinc Oxide STICK TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 Isis Enterprises LLC DBA: S4 Suncare TITANIUM DIOXIDE; ZINC OXIDE 5.8; 4.51 g/100g; g/100g 62309-777_6e8d8fde-2617-4880-9cc1-0f036cb71093 62309-777 HUMAN OTC DRUG Solves - aspirin Cherry Aspirin STRIP ORAL 20140501 OTC MONOGRAPH FINAL part343 Pace Wellness Inc. ASPIRIN 81 mg/1 62309-779_8b22716f-068c-41ac-a4a9-01aa761da579 62309-779 HUMAN OTC DRUG Solves - aspirin Cherry Aspirin STRIP ORAL 20140501 OTC MONOGRAPH FINAL part343 Pace Wellness Inc. ASPIRIN 81 mg/1 62333-111_06967632-a24b-4654-ae56-23410f7b1d3a 62333-111 HUMAN OTC DRUG Ivy Block Bentoquatam LOTION TOPICAL 20030303 NDA NDA020532 Standard Homeopathic Comapny QUATERNIUM-18; SODIUM BENTONITE 1.7; 3.3 g/100mL; g/100mL 62337-415_820a2d49-ad97-41ce-bfdc-fae3c92cb62f 62337-415 HUMAN OTC DRUG Pyrantel Pamoate PinwormTreatment SUSPENSION ORAL 20121017 OTC MONOGRAPH FINAL part357B Neogen Corporation dba Columbia Laboratories PYRANTEL PAMOATE 50 mg/mL 62340-001_8ebd4bf9-e0fe-425d-88a6-d7e4d74ae38f 62340-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19980101 UNAPPROVED MEDICAL GAS University of Michigan Health System dba MedEquip OXYGEN 99 L/100L 62362-012_9ce1bc91-5714-4c32-b4c6-1e8a96f907fc 62362-012 HUMAN PRESCRIPTION DRUG Neova Complex HQ Plus Hydroquinone EMULSION TOPICAL 20120109 UNAPPROVED DRUG OTHER PhotoMedex, Inc. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 62362-119_e42c5d41-b58a-41c1-834b-ea55a83bd685 62362-119 HUMAN OTC DRUG Neova Breakout Control Salicylic Acid SWAB TOPICAL 20111227 OTC MONOGRAPH FINAL part358B PhotoMedex, Inc. SALICYLIC ACID 2 mL/100mL 62362-129_657c11fe-04b0-46aa-bbbd-6b740934f08c 62362-129 HUMAN OTC DRUG Neova DNA Damage Control - Active SPF 45 Zinc Oxide, Octinoxate, Octisalate EMULSION TOPICAL 20120106 OTC MONOGRAPH FINAL part352 PhotoMedex, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 3; 8 mL/100mL; mL/100mL; mL/100mL 62362-129_c1d6e09b-2903-44ed-84a9-8701a702e19e 62362-129 HUMAN OTC DRUG Neova DNA Damage Control - Active SPF 45 Zinc Oxide, Octinoxate, Octisalate EMULSION TOPICAL 20120105 OTC MONOGRAPH FINAL part352 PhotoMedex, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 3; 8 mL/100mL; mL/100mL; mL/100mL 62362-139_9434e317-85ce-44f4-ac99-dbe37d5f6b6c 62362-139 HUMAN OTC DRUG Neova DNA Damage Control - Everyday SPF 43 Zinc Oxide, Octinoxate, Octisalate EMULSION TOPICAL 20120106 OTC MONOGRAPH FINAL part352 PhotoMedex, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 2.5; 7.5 mL/100mL; mL/100mL; mL/100mL 62362-139_a4c08463-942b-4f1d-a483-1d56aee78d85 62362-139 HUMAN OTC DRUG Neova DNA Damage Control - Everyday SPF 43 Zinc Oxide, Octinoxate, Octisalate EMULSION TOPICAL 20120106 OTC MONOGRAPH FINAL part352 PhotoMedex, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 2.5; 7.5 mL/100mL; mL/100mL; mL/100mL 62362-149_0542c9e9-5d1f-4485-9568-fe9f48b1d220 62362-149 HUMAN OTC DRUG Neova DNA Damage Control - Silc Sheer SPF 45 Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120109 OTC MONOGRAPH FINAL part352 PhotoMedex, Inc. OCTINOXATE; TITANIUM DIOXIDE 6.5; 3.5 mL/100mL; mL/100mL 62362-149_cc4ff974-a89e-4731-a823-4be5d3869f24 62362-149 HUMAN OTC DRUG Neova DNA Damage Control - Silc Sheer SPF 45 Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120106 OTC MONOGRAPH FINAL part352 PhotoMedex, Inc. OCTINOXATE; TITANIUM DIOXIDE 6.5; 3.5 mL/100mL; mL/100mL 62362-159_49d543b3-13b4-480e-82a5-acb565474a38 62362-159 HUMAN OTC DRUG Neova DNA Damage Control - Everyday Broad Spectrum SPF 44 Octinoxate, Octisalate, Zinc Oxide EMULSION TOPICAL 20121008 OTC MONOGRAPH NOT FINAL part352 PhotoMedex, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 6.5; 2.5; 8.5 g/100mL; g/100mL; g/100mL 62362-169_d0dfabc7-480a-4048-b07e-080127d7c18d 62362-169 HUMAN OTC DRUG Neova DNA Damage Control - Silc Sheer Broad Spectrum SPF 40 Octinoxate, Titanium Dioxide, Zinc Oxide EMULSION TOPICAL 20121008 OTC MONOGRAPH NOT FINAL part352 PhotoMedex, Inc. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 3; 9 g/100mL; g/100mL; g/100mL 62362-179_9cf6b022-df2a-430a-b216-3f7ec60d657f 62362-179 HUMAN OTC DRUG Neova DNA Damage Control - Active Broad Spectrum SPF 43 Octinoxate, Zinc Oxide EMULSION TOPICAL 20121008 OTC MONOGRAPH NOT FINAL part352 PhotoMedex, Inc. OCTINOXATE; ZINC OXIDE 7.5; 9 g/100mL; g/100mL 62362-184_a752b6e4-63cd-4812-9e70-82829e1a72dd 62362-184 HUMAN OTC DRUG Neova Day Therapy SPF 30 Homosalate, Octocrylene, Octisalate, Avobenzone LOTION TOPICAL 20120111 OTC MONOGRAPH FINAL part352 PhotoMedex, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 7; 5; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62362-184_adc0c9f7-391a-46d8-aff7-015f380eac70 62362-184 HUMAN OTC DRUG Neova Day Therapy SPF 30 Homosalate, Octocrylene, Octisalate, Avobenzone LOTION TOPICAL 20120111 OTC MONOGRAPH FINAL part352 PhotoMedex, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 7; 5; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62362-184_f8f06252-e947-4062-b647-e3b375787a19 62362-184 HUMAN OTC DRUG Neova Day Therapy SPF 30 Homosalate, Octocrylene, Octisalate, Avobenzone LOTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 PhotoMedex, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 7; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL 62366-124_f41c58a1-991e-462e-a3aa-d6fc02683e76 62366-124 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20140113 OTC MONOGRAPH NOT FINAL part333A Medical Speciaties Distributors, LLC ISOPROPYL ALCOHOL .7 mL/mL 62372-700_e0cd5263-15e1-4a2f-8d48-9eff157fac2b 62372-700 HUMAN OTC DRUG Dr. Cocoa Non-Drowsy Cough Dextromethorphan Hydrobromide LIQUID ORAL 20140601 OTC MONOGRAPH FINAL part341 Infirst Healthcare DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg/5mL 62372-721_9b6c679e-14d2-4cc2-bc74-feb8a40685d9 62372-721 HUMAN OTC DRUG Dr. Cocoa Daytime Cough and Cold Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20140620 OTC MONOGRAPH FINAL part341 Infirst Healthcare DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 62372-743_a01c27f2-061f-4bdc-bea9-7c1d39ebe385 62372-743 HUMAN OTC DRUG Dr. Cocoa Nighttime Cough and Cold Diphenhydramine Hydrchloride, Phenylephrine Hydrochloride LIQUID ORAL 20140620 OTC MONOGRAPH FINAL part341 Infirst Healthcare DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 62382-0308_0685b7dd-995c-5175-e054-00144ff8d46c 62382-0308 HUMAN OTC DRUG Easy to break-off cleaning and disinfecting swabstick JJB-I Alcohol swabstick SWAB TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Longood Medicine (Beijing) Co., Ltd. ALCOHOL .7 mL/mL 62382-0315_957329b1-17ac-49d4-b01c-3d39815a9c6d 62382-0315 HUMAN OTC DRUG Easy to break-off cleaning and disinfecting swabstick YBC-I Isopropyl alcohol swabstick SWAB TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Longood Medicine (Beijing) Co., Ltd. ISOPROPYL ALCOHOL .7 mL/mL 62382-0322_f335c19a-4871-40e5-9e38-bf084b68eb5a 62382-0322 HUMAN OTC DRUG Easy to break-off cleaning and disinfecting swabstick DFB-I Povidone iodine swabstick SWAB TOPICAL 20140328 OTC MONOGRAPH NOT FINAL part333A Longood Medicine (Beijing) Co., Ltd. POVIDONE-IODINE .1 mg/mL 62391-001_0b669957-1ea3-45ff-83a4-851ee52b5e51 62391-001 HUMAN OTC DRUG BioFlexor Menthol GEL TOPICAL 19980301 OTC MONOGRAPH FINAL part346 Health Care Laboratories Inc. MENTHOL .03 g/g 62428-505_4ce03b23-3b02-41b0-ab8d-148a5e4dd5f4 62428-505 HUMAN OTC DRUG Drummond American Trade Wind Antimicrobial Chloroxylenol LIQUID TOPICAL 19981028 OTC MONOGRAPH NOT FINAL part333 Lawson Products, Inc. CHLOROXYLENOL 10.22 g/1000mL 62440-279_b87223f8-1c5a-4e77-b744-43d87181d397 62440-279 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20140305 OTC MONOGRAPH NOT FINAL part333A Swinton Avenue Trading Ltd.Inc. BENZALKONIUM CHLORIDE 1.3 g/mL 62440-370_932a089f-5272-4fb3-bc6f-efe35712acf6 62440-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part333A Swinton Avenue Trading Ltd, Inc. ALCOHOL 70 mL/100mL 62440-439_c487cd8f-0c0a-410f-a35d-794cf5aa0160 62440-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part333A Swinton Avenue Trading LTD.Inc. ALCOHOL 700 mg/mL 62442-001_dbccd9f3-472d-4233-83bd-5a892db4591e 62442-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19370101 UNAPPROVED MEDICAL GAS Mediserve Medical Equipment, Inc. OXYGEN 99 L/100L 62447-0010_5f093e20-be28-48d9-ac83-f2f5524d0f92 62447-0010 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19870101 UNAPPROVED MEDICAL GAS Bradshaw's Industrial Supply, Inc. dba Interstate Welding Supply OXYGEN 99 L/100L 62450-001_9194048e-5b6d-4f5d-b410-79cca5382ff2 62450-001 HUMAN OTC DRUG Attends Daily Barrier Dimethicone, Zinc Oxide SPRAY TOPICAL 20140306 OTC MONOGRAPH FINAL part347 Purna Pharmaceuticals NV DIMETHICONE; ZINC OXIDE 2; 4 g/99g; g/99g 62450-002_0e4eb444-7f9f-495f-a3f3-b3c5bbdc858c 62450-002 HUMAN OTC DRUG Attends Advanced Barrier Zinc Oxide SPRAY TOPICAL 20140306 OTC MONOGRAPH FINAL part347 Purna Pharmaceuticals NV ZINC OXIDE 10 g/99g 62481-4565_170cd797-4654-4840-a660-b01dedce6631 62481-4565 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19970401 UNAPPROVED MEDICAL GAS Bay State Medical, Inc. OXYGEN 99 L/100L 62484-0020_1f7bb924-ca3f-4cd0-a8f1-820795054b71 62484-0020 HUMAN PRESCRIPTION DRUG PURIXAN Purixan SUSPENSION ORAL 20140428 NDA NDA205919 Nova Laboratories, Ltd MERCAPTOPURINE 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 62486-130_efd2f6f7-a340-448b-8d8b-f55c91aa24f2 62486-130 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19370101 UNAPPROVED MEDICAL GAS Advocate Home Care Products OXYGEN 99 L/100L 62499-384_a1bf5e85-1fd0-4050-8071-f15f3bc6042b 62499-384 HUMAN OTC DRUG SEBOBALANCE Spot Control Salicylic Acid GEL TOPICAL 20100630 OTC MONOGRAPH FINAL part358H Laboratoire Dr. Renaud SALICYLIC ACID 1 g/100g 62499-392_0786cbe9-dc97-45e2-b3b0-35a2aa08db31 62499-392 HUMAN OTC DRUG CLEAR UP Control Solution Anti-Blemiches SALICYLIC ACID GEL TOPICAL 20100629 OTC MONOGRAPH FINAL part358H Laboratoire Dr. Renaud SALICYLIC ACID 2 g/100g 62499-394_94f6aeed-9e30-459d-8d1f-dbbaa07c1b15 62499-394 HUMAN OTC DRUG CLEAR UP Cleansing Salicylic Acid GEL TOPICAL 20100628 OTC MONOGRAPH FINAL part358H Laboratoire Dr. Renaud SALICYLIC ACID 2 g/100g 62499-395_54210f16-ce52-4575-85c3-a5e8b9f58f52 62499-395 HUMAN OTC DRUG CLEAR UP Prep Salicylic Acid GEL TOPICAL 20100701 OTC MONOGRAPH FINAL part358H Laboratoire Dr. Renaud SALICYLIC ACID 2 g/100g 62499-420_9d8f4ada-04b4-4bcb-a3b3-ab5e5ad0693f 62499-420 HUMAN OTC DRUG SPF 15 Protective Balm with UVA/UVB Sunscreens Octinoxate Octisalate Oxybenzone STICK TOPICAL 20110321 OTC MONOGRAPH NOT FINAL part352 Laboratoire Dr Renaud inc. OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 3; 3 g/100g; g/100g; g/100g 62499-445_2362cebc-f7d7-468f-930f-a85e96afad5d 62499-445 HUMAN OTC DRUG SPF 15 Anti-shine moisturizing OCTINOXATE and OCTOCRYLENE LOTION TOPICAL 20111129 OTC MONOGRAPH FINAL part352 Laboratoire Dr Renaud Inc. OCTINOXATE; OCTOCRYLENE 7.77; .1 g/100g; g/100g 62499-535_6d00776f-043e-4e47-974d-a9f6fa630108 62499-535 HUMAN OTC DRUG SEBOBALANCE Purifying Sebo-absorbing Mask Salicylic Acid PASTE TOPICAL 20100629 OTC MONOGRAPH FINAL part358H Laboratoire Dr. Renaud SALICYLIC ACID 1 g/100g 62504-968_ab5cbf83-c8b2-4773-b1a1-4b79a79a79e5 62504-968 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Cryogenic Medical Gases, LLC OXYGEN 99 L/100L 62510-001_1142867e-06b2-41a8-a609-55d0ec7b51ad 62510-001 HUMAN OTC DRUG RADICAL SKINCARE SKIN PERFECTING SCREEN SPF 30 ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20140210 OTC MONOGRAPH NOT FINAL part352 RADICAL BEAUTY USA INC TITANIUM DIOXIDE; ZINC OXIDE 58.7; 77.5 mg/mL; mg/mL 62541-201_ccb461be-1775-4c50-8c68-e8029d001adc 62541-201 HUMAN PRESCRIPTION DRUG Qsymia phentermine and topiramate CAPSULE, EXTENDED RELEASE ORAL 20120917 NDA NDA022580 Vivus, Inc. PHENTERMINE HYDROCHLORIDE; TOPIRAMATE 3.75; 23 mg/1; mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC],Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CIV 62541-202_ccb461be-1775-4c50-8c68-e8029d001adc 62541-202 HUMAN PRESCRIPTION DRUG Qsymia phentermine and topiramate CAPSULE, EXTENDED RELEASE ORAL 20120917 NDA NDA022580 Vivus, Inc. PHENTERMINE HYDROCHLORIDE; TOPIRAMATE 7.5; 46 mg/1; mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC],Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CIV 62541-203_ccb461be-1775-4c50-8c68-e8029d001adc 62541-203 HUMAN PRESCRIPTION DRUG Qsymia phentermine and topiramate CAPSULE, EXTENDED RELEASE ORAL 20120917 NDA NDA022580 Vivus, Inc. PHENTERMINE HYDROCHLORIDE; TOPIRAMATE 11.25; 69 mg/1; mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC],Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CIV 62541-204_ccb461be-1775-4c50-8c68-e8029d001adc 62541-204 HUMAN PRESCRIPTION DRUG Qsymia phentermine and topiramate CAPSULE, EXTENDED RELEASE ORAL 20120917 NDA NDA022580 Vivus, Inc. PHENTERMINE HYDROCHLORIDE; TOPIRAMATE 15; 92 mg/1; mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC],Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CIV 62541-301_84aaad68-ffc6-4aa6-94c4-0e3469e6aa96 62541-301 HUMAN PRESCRIPTION DRUG Stendra avanafil TABLET ORAL 20131227 NDA NDA202276 VIVUS, Inc. AVANAFIL 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 62541-302_84aaad68-ffc6-4aa6-94c4-0e3469e6aa96 62541-302 HUMAN PRESCRIPTION DRUG Stendra avanafil TABLET ORAL 20131227 NDA NDA202276 VIVUS, Inc. AVANAFIL 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 62541-303_84aaad68-ffc6-4aa6-94c4-0e3469e6aa96 62541-303 HUMAN PRESCRIPTION DRUG Stendra avanafil TABLET ORAL 20131227 NDA NDA202276 VIVUS, Inc. AVANAFIL 200 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 62542-301_0a442026-486e-105a-e054-00144ff88e88 62542-301 HUMAN PRESCRIPTION DRUG Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended Release Oral Suspension Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended Release Oral Suspension LIQUID, EXTENDED RELEASE ORAL 20141031 ANDA ANDA091671 Neos Therapeutics, LP CHLORPHENIRAMINE; HYDROCODONE 8; 10 mg/5mL; mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Opioid Agonist [EPC],Opioid Agonists [MoA] CII 62547-001_006551a1-58a6-495d-9f39-23e96ff81c93 62547-001 HUMAN OTC DRUG ANTI-AGING TINTED MOISTURIZER AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 Dedra LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL 62558-001_610d1035-f3ca-4683-9344-3271bb22937d 62558-001 HUMAN OTC DRUG Doctor Manzanilla Cough Suppressant and Nasal Decongestant DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20140304 OTC MONOGRAPH FINAL part341 Mid Valley Pharmaceuticals LLC DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 125; 50 mg/mL; mg/mL 62559-110_d7db6cd8-b2d2-427f-bea7-94df998ffca5 62559-110 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide SOLUTION ORAL 20110310 ANDA ANDA071402 ANIP Acquisition Company METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 62559-111_a307448a-ccc4-41a8-977a-11f28f0bded9 62559-111 HUMAN PRESCRIPTION DRUG Cortenema Hydrocortisone ENEMA RECTAL 20120810 NDA NDA016199 ANIP Acquisition Company HYDROCORTISONE 100 mg/60mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 62559-138_40654d12-56e4-4489-be49-19c60ad918ad 62559-138 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone ENEMA RECTAL 20120816 NDA NDA017854 ANIP Acquisition Company HYDROCORTISONE 100 mg/60mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 62559-149_5fd30aae-b052-4182-80e7-ad766bc3443a 62559-149 HUMAN PRESCRIPTION DRUG Esterified Estrogens and Methyltestosterone Esterified Estrogens and Methyltestosterone TABLET ORAL 20101222 UNAPPROVED DRUG OTHER ANIP Acquisition Company ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE 1.25; 2.5 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 62559-150_5fd30aae-b052-4182-80e7-ad766bc3443a 62559-150 HUMAN PRESCRIPTION DRUG Esterified Estrogens and Methyltestosterone Esterified Estrogens and Methyltestosterone TABLET ORAL 20101222 UNAPPROVED DRUG OTHER ANIP Acquisition Company ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE .625; 1.25 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 62559-153_bd6093ae-db19-437d-be34-50edafc29599 62559-153 HUMAN PRESCRIPTION DRUG Opium tincture deodorized morphine tincture SOLUTION ORAL 20110225 UNAPPROVED DRUG OTHER ANIP Acquisition Company MORPHINE 1 g/100mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 62559-158_713aca56-88bd-449f-bafa-ce9b02c8d509 62559-158 HUMAN PRESCRIPTION DRUG fluvoxamine maleate Fluvoxamine maleate TABLET, COATED ORAL 20110809 NDA AUTHORIZED GENERIC NDA021519 ANIP Acquisition Company FLUVOXAMINE MALEATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 62559-159_713aca56-88bd-449f-bafa-ce9b02c8d509 62559-159 HUMAN PRESCRIPTION DRUG fluvoxamine maleate Fluvoxamine maleate TABLET, COATED ORAL 20110809 NDA AUTHORIZED GENERIC NDA021519 ANIP Acquisition Company FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 62559-160_713aca56-88bd-449f-bafa-ce9b02c8d509 62559-160 HUMAN PRESCRIPTION DRUG fluvoxamine maleate Fluvoxamine maleate TABLET, COATED ORAL 20110809 NDA AUTHORIZED GENERIC NDA021519 ANIP Acquisition Company FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 62559-165_986b3026-c76c-44d1-91ff-c54a7f69fd6f 62559-165 HUMAN PRESCRIPTION DRUG Reglan Metoclopramide Hydrochloride TABLET ORAL 20110705 NDA NDA017854 ANI Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 62559-166_986b3026-c76c-44d1-91ff-c54a7f69fd6f 62559-166 HUMAN PRESCRIPTION DRUG Reglan Metoclopramide Hydrochloride TABLET ORAL 20110705 NDA NDA017854 ANI Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 62559-240_c26c8834-961e-4c9c-9ad4-5db2d9419938 62559-240 HUMAN PRESCRIPTION DRUG Methazolamide Methazolamide TABLET ORAL 20141106 ANDA ANDA040001 ANI Pharmaceuticals, Inc. METHAZOLAMIDE 25 mg/1 62559-241_c26c8834-961e-4c9c-9ad4-5db2d9419938 62559-241 HUMAN PRESCRIPTION DRUG Methazolamide Methazolamide TABLET ORAL 20141106 ANDA ANDA040001 ANI Pharmaceuticals, Inc. METHAZOLAMIDE 50 mg/1 62559-280_f7f5b69a-c2a1-4586-a189-1475d41387c0 62559-280 HUMAN PRESCRIPTION DRUG LITHOBID lithium carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140701 NDA NDA018027 ANI Pharmaceuticals, Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 62559-310_fa7aab3d-13bc-47c6-a83a-35b07a64094e 62559-310 HUMAN PRESCRIPTION DRUG Vancocin vancomycin hydrochloride CAPSULE ORAL 20141117 NDA NDA050606 ANI Pharmaceuticals, Inc. VANCOMYCIN HYDROCHLORIDE 125 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 62559-311_fa7aab3d-13bc-47c6-a83a-35b07a64094e 62559-311 HUMAN PRESCRIPTION DRUG Vancocin vancomycin hydrochloride CAPSULE ORAL 20141117 NDA NDA050606 ANI Pharmaceuticals, Inc. VANCOMYCIN HYDROCHLORIDE 250 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 62565-901_e84c6bc3-8bee-4966-a981-8a2d400a9973 62565-901 HUMAN PRESCRIPTION DRUG ONE TOUCH ADVANCED TOPICAL ANESTHETIC GEL COOL MINT BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE GEL DENTAL; TOPICAL 20090201 UNAPPROVED DRUG OTHER HAGER WORLDWIDE, INC. BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE 28; 4; 4 mg/.2g; mg/.2g; mg/.2g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 62565-902_69f13372-d95d-4dbc-ae03-ed9a0b49592a 62565-902 HUMAN PRESCRIPTION DRUG ONE TOUCH ADVANCED TOPICAL ANESTHETIC STRAWBERRY ICE BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE GEL DENTAL; TOPICAL 20090201 UNAPPROVED DRUG OTHER HAGER WORLDWIDE, INC. BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE 28; 4; 4 mg/.2g; mg/.2g; mg/.2g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 62565-903_b86fa8eb-3daa-4f1d-bbbe-6a87b21f13a9 62565-903 HUMAN PRESCRIPTION DRUG ONE TOUCH ADVANCED TOPICAL ANESTHETIC BUBBLE GUM BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE GEL DENTAL; TOPICAL 20090201 UNAPPROVED DRUG OTHER HAGER WORLDWIDE, INC. BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE 28; 4; 4 mg/.2g; mg/.2g; mg/.2g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 62565-904_6e3df63a-232a-4b77-bb70-0cd9c0a7ac64 62565-904 HUMAN PRESCRIPTION DRUG ONE TOUCH ADVANCED TOPICAL ANESTHETIC CHERRY BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE GEL DENTAL; TOPICAL 20090201 UNAPPROVED DRUG OTHER HAGER WORLDWIDE, INC. BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE 28; 4; 4 mg/.2g; mg/.2g; mg/.2g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 62566-001_40de5187-edbe-438a-87b2-05bcb0d434b2 62566-001 HUMAN OTC DRUG Venus White Clean Mint Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Heraeus Kulzer LLC SODIUM FLUORIDE .28 g/113g 62569-000_64364a1d-56f7-4555-9cd6-73fecccd1b44 62569-000 HUMAN OTC DRUG Genlabs Strike Bac Antibacterial Handsoap CHLOROXYLENOL SOAP TOPICAL 20130829 OTC MONOGRAPH NOT FINAL part333E Genlabs Corporation CHLOROXYLENOL 2.5 mg/.001L 62577-613_a4a1dbf5-6d2d-4f27-b051-f30c8cd5378a 62577-613 VACCINE Flucelvax INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20140701 BLA BLA125408 Novartis Vaccines and Diagnostics, Inc. INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL 62581-1234_77db6169-d859-4799-ad3e-d637056ac54d 62581-1234 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19790101 UNAPPROVED MEDICAL GAS Dubois Medical Supply Company, Inc OXYGEN 99 L/100L 62583-001_82433dc0-dabc-4277-8013-d1ebf07dd61f 62583-001 HUMAN OTC DRUG BRONCOLIN Herbal extracts and Honey Menthol LOZENGE ORAL 20140401 OTC MONOGRAPH FINAL part341 BRONCOLIN, S.A. de C.V. MENTHOL 7.5 mg/1 62584-046_79d6a5ea-77d3-4547-aa67-1b465141b1f5 62584-046 HUMAN PRESCRIPTION DRUG DIDANOSINE DIDANOSINE CAPSULE, DELAYED RELEASE ORAL 20091208 ANDA ANDA077167 American Health Packaging DIDANOSINE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 62584-048_79d6a5ea-77d3-4547-aa67-1b465141b1f5 62584-048 HUMAN PRESCRIPTION DRUG DIDANOSINE DIDANOSINE CAPSULE, DELAYED RELEASE ORAL 20091208 ANDA ANDA077167 American Health Packaging DIDANOSINE 400 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 62584-142_84bbd612-4232-42de-8090-5e01d4bb6c0c 62584-142 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071109 ANDA ANDA077794 American Health Packaging OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62584-143_84bbd612-4232-42de-8090-5e01d4bb6c0c 62584-143 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071109 ANDA ANDA077794 American Health Packaging OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62584-145_84bbd612-4232-42de-8090-5e01d4bb6c0c 62584-145 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071109 ANDA ANDA077794 American Health Packaging OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62584-159_85221ba6-8417-499a-9f74-b2d714a7a560 62584-159 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET ORAL 20101130 ANDA ANDA065425 American Health Packaging DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 62584-163_85221ba6-8417-499a-9f74-b2d714a7a560 62584-163 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET ORAL 20101215 ANDA ANDA065425 American Health Packaging DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 62584-259_f15d0d2a-3937-4ccf-b57b-e29a8d5acd64 62584-259 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20091118 ANDA ANDA077064 American Health Packaging METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 62584-265_7e3e4484-6d9a-4c5d-849d-b2e8ea0cd424 62584-265 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20100609 ANDA ANDA077739 American Health Packaging METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 62584-266_7e3e4484-6d9a-4c5d-849d-b2e8ea0cd424 62584-266 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20100622 ANDA ANDA077739 American Health Packaging METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 62584-267_7e3e4484-6d9a-4c5d-849d-b2e8ea0cd424 62584-267 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20100726 ANDA ANDA077739 American Health Packaging METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 62584-330_9ba1cfd8-14c9-4de6-88cb-8a78a1d40a53 62584-330 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET ORAL 20100528 ANDA ANDA080439 American Health Packaging CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 62584-331_9ba1cfd8-14c9-4de6-88cb-8a78a1d40a53 62584-331 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET ORAL 20100528 ANDA ANDA080439 American Health Packaging CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 62584-332_f15d0d2a-3937-4ccf-b57b-e29a8d5acd64 62584-332 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20091118 ANDA ANDA077064 American Health Packaging METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 62584-339_e35d241b-2d4e-4712-abcb-678842687395 62584-339 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20130520 ANDA ANDA070975 American Health Packaging CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 62584-452_f15d0d2a-3937-4ccf-b57b-e29a8d5acd64 62584-452 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20091118 ANDA ANDA077064 American Health Packaging METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 62584-467_e3be79e8-0c90-475a-b72e-792a4dfa3efb 62584-467 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20040804 ANDA ANDA073025 American Health Packaging ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 62584-612_15e83cd1-79a7-4a96-bc18-7818228a4877 62584-612 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine hydrochloride CAPSULE ORAL 20101021 ANDA ANDA078720 American Health Packaging AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 62584-639_743d1398-942d-4d2f-9547-79c395238447 62584-639 HUMAN PRESCRIPTION DRUG Carbamazepine (Chewable) Carbmazepine (Chewable) TABLET, CHEWABLE ORAL 20091118 ANDA ANDA075712 American Health Packaging CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 62584-657_e35d241b-2d4e-4712-abcb-678842687395 62584-657 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20130520 ANDA ANDA070974 American Health Packaging CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 62584-659_e35d241b-2d4e-4712-abcb-678842687395 62584-659 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20130520 ANDA ANDA070976 American Health Packaging CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 62584-683_24ae1e96-3061-447f-8497-2a18741744ac 62584-683 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20101108 UNAPPROVED DRUG OTHER American Health Packaging DOCUSATE SODIUM 100 mg/1 62584-693_10988250-b267-4f10-b264-5f127cc1ae18 62584-693 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20130322 ANDA ANDA065095 American Health Packaging DOXYCYCLINE HYCLATE 100 mg/1 62584-713_29ee62a9-6629-4210-bcca-6c9c6ce8bd42 62584-713 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090311 ANDA ANDA018832 American Health Packaging ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 62584-715_e3be79e8-0c90-475a-b72e-792a4dfa3efb 62584-715 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20040804 ANDA ANDA073026 American Health Packaging ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 62584-733_8c6d2d47-4749-43ca-bc02-779672e3df37 62584-733 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20080318 ANDA ANDA086242 American Health Packaging HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 62584-734_8c6d2d47-4749-43ca-bc02-779672e3df37 62584-734 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20080318 ANDA ANDA086242 American Health Packaging HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 62584-739_6839eaa1-2d1c-409f-80f9-25328c7e2767 62584-739 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20130612 ANDA ANDA087479 American Health Packaging HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 62584-741_6839eaa1-2d1c-409f-80f9-25328c7e2767 62584-741 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20130612 ANDA ANDA086183 American Health Packaging HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 62584-746_503828d6-cee0-40b1-a5eb-f484023c420e 62584-746 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110323 ANDA ANDA075682 American Health Packaging IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 62584-747_503828d6-cee0-40b1-a5eb-f484023c420e 62584-747 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110323 ANDA ANDA075682 American Health Packaging IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 62584-748_503828d6-cee0-40b1-a5eb-f484023c420e 62584-748 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110324 ANDA ANDA075682 American Health Packaging IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 62584-780_f5f32393-581e-4f29-bff0-99cfd8a36ee9 62584-780 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20100901 ANDA ANDA084277 American Health Packaging METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 62584-781_f5f32393-581e-4f29-bff0-99cfd8a36ee9 62584-781 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20100901 ANDA ANDA084276 American Health Packaging METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 62584-812_80ea902e-40d3-4fad-b91a-d7e09f76ed0d 62584-812 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE ORAL 20130705 ANDA ANDA072251 American Health Packaging OXAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 62584-813_80ea902e-40d3-4fad-b91a-d7e09f76ed0d 62584-813 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE ORAL 20130705 ANDA ANDA072252 American Health Packaging OXAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 62584-814_80ea902e-40d3-4fad-b91a-d7e09f76ed0d 62584-814 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE ORAL 20130705 ANDA ANDA072253 American Health Packaging OXAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 62584-827_770b1c29-2e06-4627-b8a1-d3f8078288c3 62584-827 HUMAN PRESCRIPTION DRUG CYCLOSPORINE CYCLOSPORINE CAPSULE ORAL 20091211 ANDA ANDA065040 American Health Packaging CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 62584-886_3dc43b70-5c41-4387-9037-ff813cc2abae 62584-886 HUMAN PRESCRIPTION DRUG TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE TABLET ORAL 20100112 ANDA ANDA040254 American Health Packaging TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 62584-887_3dc43b70-5c41-4387-9037-ff813cc2abae 62584-887 HUMAN PRESCRIPTION DRUG TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE TABLET ORAL 20100112 ANDA ANDA040254 American Health Packaging TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 62584-897_4e0a3410-754c-4344-8b0f-f880c598e889 62584-897 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20130529 ANDA ANDA040625 American Health Packaging FOLIC ACID 1 mg/1 62584-974_b25d7fd9-f9d6-4cb8-a261-3fed63baa638 62584-974 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100115 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62584-975_b25d7fd9-f9d6-4cb8-a261-3fed63baa638 62584-975 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100115 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62584-976_b25d7fd9-f9d6-4cb8-a261-3fed63baa638 62584-976 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100115 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62584-977_b25d7fd9-f9d6-4cb8-a261-3fed63baa638 62584-977 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100115 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 62584-984_d63d7b8d-69e1-4887-a138-37144eab7b55 62584-984 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20120402 ANDA ANDA040301 American Health Packaging WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 62584-988_29ee62a9-6629-4210-bcca-6c9c6ce8bd42 62584-988 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090311 ANDA ANDA018832 American Health Packaging ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 62584-994_d63d7b8d-69e1-4887-a138-37144eab7b55 62584-994 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20120402 ANDA ANDA040301 American Health Packaging WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 62587-119_cff3df5e-20bf-4bd8-806a-16a93a2f9bfb 62587-119 HUMAN OTC DRUG YSNORE DIOSCOREA VILLOSA ROOT, GINGER LIQUID NASAL 20140102 UNAPPROVED HOMEOPATHIC Y Snore DIOSCOREA VILLOSA ROOT; GINGER 2; 2 [hp_X]/mL; [hp_X]/mL 62587-219_969b5d09-3836-459c-b89f-4bc26e7dee86 62587-219 HUMAN OTC DRUG YSNORE DIOSCOREA VILLOSA ROOT, GINGER SPRAY NASAL 20140102 UNAPPROVED HOMEOPATHIC Y Snore DIOSCOREA VILLOSA ROOT; GINGER 2; 2 [hp_X]/mL; [hp_X]/mL 62592-188_a2eaf983-2ef0-424a-bfc6-abb527bfb308 62592-188 HUMAN PRESCRIPTION DRUG Buphenyl sodium phenylbutyrate POWDER ORAL 19960430 20150228 NDA NDA020573 Ucyclyd Pharma Inc. SODIUM PHENYLBUTYRATE .94 g/g Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] 62592-496_a2eaf983-2ef0-424a-bfc6-abb527bfb308 62592-496 HUMAN PRESCRIPTION DRUG Buphenyl sodium phenylbutyrate TABLET ORAL 19960513 20150228 NDA NDA020572 Ucyclyd Pharma Inc. SODIUM PHENYLBUTYRATE 500 mg/1 Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] 62592-720_d4391516-4c73-4290-90c6-f1fb14e62277 62592-720 HUMAN PRESCRIPTION DRUG Ammonul sodium phenylacetate and sodium benzoate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20050217 NDA NDA020645 Ucyclyd Pharma Inc. SODIUM BENZOATE; SODIUM PHENYLACETATE 100; 100 mg/mL; mg/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] 62598-001_01a53ef0-7102-4f45-bc47-3345ffcd7b7c 62598-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140217 UNAPPROVED MEDICAL GAS Millennium Medical Supply OXYGEN 99 L/100L 62600-100_6b50fb4f-5129-4c83-bfa6-3a4a72ae35ee 62600-100 HUMAN OTC DRUG SECRETIPSS SCALP HAIR ESSENTIAL BOOSTER Allantoin LIQUID TOPICAL 20140201 OTC MONOGRAPH FINAL part347 Innocence, Inc. ALLANTOIN .48 mg/80mL 62600-110_85240073-5340-4fbb-9ed8-17560505aac9 62600-110 HUMAN OTC DRUG SECRETIPSS SCALP HAIR ESSENTIAL TONIC PLUS Allantoin LIQUID TOPICAL 20140201 OTC MONOGRAPH FINAL part347 Innocence, Inc. ALLANTOIN .48 mg/80mL 62620-1001_4235ae9a-79d6-4f7b-9084-571ebcb5c092 62620-1001 HUMAN OTC DRUG FEDORA Oriental Spa Ampoule GLYCERIN LIQUID TOPICAL 20140306 OTC MONOGRAPH FINAL part347 Fedora International Co., Ltd. GLYCERIN .0798 g/mL 62620-2001_cf1f29bb-7469-4217-92da-6a65b8c56f0a 62620-2001 HUMAN OTC DRUG MIRU Oriental Whitening Ampoule GLYCERIN LIQUID TOPICAL 20140306 OTC MONOGRAPH FINAL part347 Fedora International Co., Ltd. GLYCERIN .0224 g/mL 62622-124_282fb2cb-63fa-4e07-a988-6bd8893d5ebe 62622-124 HUMAN OTC DRUG MiniDrops Lubricant eye drops LIQUID OPHTHALMIC 19910401 OTC MONOGRAPH FINAL part349 Taiwan Biotech Co, Ltd POLYVINYL ALCOHOL; POVIDONE K30 1.4; .6 mL/100mL; mL/100mL 62627-100_ab130e31-1a1b-41dd-b76e-76907d95a658 62627-100 HUMAN PRESCRIPTION DRUG Nitronal Nitroglycerin INJECTION, SOLUTION INTRAVENOUS 20140407 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE G. POHL-BOSKAMP GmbH & Co. KG NITROGLYCERIN 1 mg/mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 62630-001_ec04d15a-a953-4c26-b5ab-743ec1e06aa6 62630-001 HUMAN OTC DRUG PREQUIMM Veratrum Album, Colchicum Autumnale, Conium Maculatum, Ipecacuanha, Nux Vomica, Argentum Nitricum, Pulsatilla Pratensis TABLET, ORALLY DISINTEGRATING ORAL 20140501 UNAPPROVED HOMEOPATHIC ZRG DETOX, INC. COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; IPECAC; PULSATILLA PRATENSIS; SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 4; 4; 4; 6; 6; 4; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 62638-001_f99559d5-ef40-485e-821f-a17db6c061fe 62638-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140305 UNAPPROVED MEDICAL GAS Home Medical Equipment Specialists, LLC OXYGEN 99 L/100L 62646-120_79de796b-c2b4-4221-984a-86009c5f426d 62646-120 HUMAN PRESCRIPTION DRUG Nutricel Additive System - CP2D CP2D/AS-3 Anticoagulant and Additive System SOLUTION INTRAVENOUS 20120201 NDA NDA820915 Medsep Corporation CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .229; 3.57; 1.84; .155 g/70mL; g/70mL; g/70mL; g/70mL 62646-791_1b36f09f-c2cc-429a-859e-a673fc50ad1b 62646-791 HUMAN PRESCRIPTION DRUG Sterile Cord Blood Collection Unit Cord Blood Collection Unit SOLUTION INTRAVENOUS 20110316 NDA NDA800222 Medsep Corporation CITRIC ACID; DEXTROSE MONOHYDRATE; SODIUM CITRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .114; .893; .921; .078 g/35mL; g/35mL; g/35mL; g/35mL 62646-798_a083fb8e-3012-4d12-94d3-949a3188aba3 62646-798 HUMAN PRESCRIPTION DRUG Anticoagulant Sodium Citrate Sodium Citrate SOLUTION INTRAVENOUS 20110415 NDA NDA760305 Medsep Corporation SODIUM CITRATE 10 g/250mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 62646-AS3_79de796b-c2b4-4221-984a-86009c5f426d 62646-AS3 HUMAN PRESCRIPTION DRUG Nutricel Additive System - AS-3 CP2D/AS-3 Anticoagulant and Additive System SOLUTION INTRAVENOUS 20120201 NDA NDA820915 Medsep Corporation ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM CITRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .033; .046; 1.21; .451; .647; .304 g/110mL; g/110mL; g/110mL; g/110mL; g/110mL; g/110mL 62651-001_797a138c-6e8e-415a-aa92-3835dd058057 62651-001 HUMAN OTC DRUG Unscented Hand Sanitizer ALCOHOL GEL TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part333E Base4 Group Inc. ALCOHOL 62 mL/100mL 62651-002_92e00b5d-f82e-4432-9512-4c5b6af0500e 62651-002 HUMAN OTC DRUG Vanilla Hand Sanitizer ALCOHOL GEL TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part333E Base4 Group Inc. ALCOHOL 62 mL/100mL 62654-140_5d18eae6-ed3c-4c14-81c6-53fcb7ae41f1 62654-140 HUMAN OTC DRUG DermaCen Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part333A Central Solutions Inc ALCOHOL 64.5 mL/100mL 62654-141_5da7e273-ebbb-456e-b95c-3b6b519b6943 62654-141 HUMAN OTC DRUG DermaCen Non-Alcohol Foaming Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100118 OTC MONOGRAPH NOT FINAL part333 Central Solutions Inc BENZALKONIUM CHLORIDE .13 mL/100mL 62654-142_1b2fbf7f-c4de-4219-ad7e-0d45de4d7840 62654-142 HUMAN OTC DRUG BOA VIDA Recovery Creme DIMETHICONE CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 Central Solutions Inc DIMETHICONE 1.5 g/100mL 62654-143_c6979d7b-4822-4a78-bbd7-74ece8efc602 62654-143 HUMAN OTC DRUG DermaCen Instant Hand Sanitizer with Aloe Alcohol LIQUID TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part333A Central Solutions Inc ALCOHOL 64.5 mL/100mL 62654-144_f43a0dc2-3c0e-42ca-86dc-2d4f3907814a 62654-144 HUMAN OTC DRUG BOA VIDA Canopy DIMETHICONE CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part347 Central Solutions Inc DIMETHICONE 2 g/100mL 62654-145_5fb61bd0-0bcd-4f57-a7a8-d95daa2bbb4c 62654-145 HUMAN OTC DRUG BOA VIDA Calvida ZINC OXIDE CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part347 Central Solutions Inc ZINC OXIDE 20 g/100mL 62654-146_9f1f2afe-a0f3-4a3b-a564-ca5805604b27 62654-146 HUMAN OTC DRUG BOA VIDA Cleansing DIMETHICONE CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part347 Central Solutions Inc DIMETHICONE 1.5 mL/100mL 62654-230_c89af290-d270-4c99-98f5-238adfc036fc 62654-230 HUMAN OTC DRUG DermaCen Antimicrobial-T Hand Triclosan LIQUID TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part333A Central Solutions Inc TRICLOSAN .375 mL/100mL 62654-231_d7ff3380-7017-428b-b891-bb0eb35570b2 62654-231 HUMAN OTC DRUG DermaCen Antimicrobial-P Hand CHLOROXYLENOL LIQUID TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part333A Central Solutions Inc CHLOROXYLENOL .95 mL/100mL 62654-239_6c53b5e6-fcb5-4f89-8f37-648aeed29f03 62654-239 HUMAN OTC DRUG DermaCen Foaming Antimicrobial-T Hand Triclosan LIQUID TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Central Solutions Inc TRICLOSAN .375 mL/100mL 62654-313_96284017-7865-456a-a6c8-24d53fe6b013 62654-313 HUMAN OTC DRUG DermaCen Protectant Zinc oxide CREAM TOPICAL 20010101 OTC MONOGRAPH FINAL part346 Central Solutions Inc ZINC OXIDE 5 g/100g 62670-1525_0bae134f-2bcc-4842-be2a-1ac735d6f982 62670-1525 HUMAN OTC DRUG Signature Body Japanese Cherry Blossom SPF 15 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120507 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 9; 5; 5; 5 g/100g; g/100g; g/100g; g/100g; g/100g 62670-1526_7a230629-b8f1-4c6b-a552-43ab38926c5b 62670-1526 HUMAN OTC DRUG Signature Body Moonlight Path SPF 15 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120507 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 9; 5; 5; 5 g/100g; g/100g; g/100g; g/100g; g/100g 62670-1527_b2189fd2-3ad8-478b-ae64-860334aa00f0 62670-1527 HUMAN OTC DRUG Signature Body Sweet Pea SPF 15 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120507 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 9; 5; 5; 5 g/100g; g/100g; g/100g; g/100g; g/100g 62670-1528_747aa169-0e1e-4f13-b6d4-4c0bc57ff84f 62670-1528 HUMAN OTC DRUG Signature Body Twilight Woods SPF 15 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120507 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 9; 5; 5; 5 g/100g; g/100g; g/100g; g/100g; g/100g 62670-1529_21bd50d8-c885-49c8-8a34-712f1b6310b5 62670-1529 HUMAN OTC DRUG Signature Body White Citrus SPF 15 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120507 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 9; 5; 5; 5 g/100g; g/100g; g/100g; g/100g; g/100g 62670-3571_96a816c4-eec4-4f4e-a78c-342eb77ec13c 62670-3571 HUMAN OTC DRUG Anti-Bacterial Deep Cleansing Hand Gel Vanilla Bean Noel Alcohol GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Bath & Body Works, Inc. ALCOHOL 60 g/100g 62670-3573_902b147e-338a-4932-86c7-cab02a44f931 62670-3573 HUMAN OTC DRUG Anti-Bacterial Deep Cleansing Hand Gel Winter Candy Apple Alcohol GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Bath & Body Works, Inc. ALCOHOL 60 g/100g 62670-3635_368351d9-5b20-44da-87d9-63ff4e71f9cf 62670-3635 HUMAN OTC DRUG Anti-Bacterial Hand Dancing Waters ALCOHOL GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-3636_19e69639-625d-4202-973f-8319eaa373e3 62670-3636 HUMAN OTC DRUG Anti-Bacterial Hand Japanese Cherry Blossom ALCOHOL GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-3640_7958ccc9-3586-479d-84b2-ba1e26fa6196 62670-3640 HUMAN OTC DRUG Anti-Bacterial Hand Sweet Pea ALCOHOL GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-3643_6f2ed26c-6478-496d-bb32-7994df3e3e7b 62670-3643 HUMAN OTC DRUG Anti-Bacterial Hand Warm Vanilla Sugar ALCOHOL GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-3649_2bec3077-df53-49a3-91c6-0521caff1307 62670-3649 HUMAN OTC DRUG Anti-Bacterial Hand Foam Fresh Lemon ALCOHOL LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Bath & Body Works, Inc. ALCOHOL 69 mL/100mL 62670-3683_9e6320f1-73f1-40ab-86f5-044aff18393e 62670-3683 HUMAN OTC DRUG Anti-Bacterial Hand G2G Grape ALCOHOL GEL TOPICAL 20100705 OTC MONOGRAPH NOT FINAL part333 Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-3715_b23e0e1f-f0fd-44f3-a653-0f2fbdef31b4 62670-3715 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Pure Vanilla Alcohol GEL TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part333 Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-3716_eab8a94f-bdf2-4a8b-b7a4-911c64acab1a 62670-3716 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Twilight Woods Alcohol GEL TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part333 Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-3754_2e5cd36b-3a89-4f62-a64a-32aeb519badb 62670-3754 HUMAN OTC DRUG Anti-Bacterial Hand Spray Fresh Lemon ALCOHOL LIQUID TOPICAL 20101221 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 72 mL/100mL 62670-3755_b6f76f90-6080-4a4d-a28e-e445a80b657d 62670-3755 HUMAN OTC DRUG Anti-Bacterial Hand Spray Sea Island Cotton ALCOHOL LIQUID TOPICAL 20101221 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 72 mL/100mL 62670-3756_1e4a5a05-e8b8-40ae-b4b0-200f30dd691b 62670-3756 HUMAN OTC DRUG Anti-Bacterial Hand Spray Sweet Pea ALCOHOL LIQUID TOPICAL 20101221 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 72 mL/100mL 62670-3757_d4e8ba6d-675f-4ee7-9af4-07ef56aec2bd 62670-3757 HUMAN OTC DRUG Anti-Bacterial Hand Spray Warm Vanilla Sugar ALCOHOL LIQUID TOPICAL 20101221 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 72 mL/100mL 62670-3914_eb4bb6bf-93e5-488e-b4e3-291e528f8378 62670-3914 HUMAN OTC DRUG Anti-Bacterial Deep Cleansing Hand Mandarin Nectar Triclosan SOAP TOPICAL 20110509 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-3924_8c41cadd-da6c-4542-b442-7f93943f3bbb 62670-3924 HUMAN OTC DRUG Anti-Bacterial Deep Cleansing Hand Citrus Crush Triclosan SOAP TOPICAL 20110509 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4078_bd7175db-b06e-44b7-8f26-660eac588a81 62670-4078 HUMAN OTC DRUG Anti-Bacterial Hand Lemon Alcohol GEL TOPICAL 20110728 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4164_c7efd32d-889d-45bf-93fe-3c522cb828c1 62670-4164 HUMAN OTC DRUG Anti-Bacterial Moisturizing Hand Pumpkin Caramel Latte Triclosan SOAP TOPICAL 20120403 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4245_e04d43d3-4a97-46b2-b4b4-f19d84a37378 62670-4245 HUMAN OTC DRUG Anti-Bacterial Gentle Foaming Hand Sour Patch Kids Triclosan SOAP TOPICAL 20120307 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4321_a761013c-0baf-445f-8e30-93e95bc9d298 62670-4321 HUMAN OTC DRUG Anti-Bacterial Deep Cleansing Hand Papaya Melon Scoop Triclosan SOAP TOPICAL 20130111 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4339_7af9752f-9e0c-42f4-b1a5-6b1cffe588f0 62670-4339 HUMAN OTC DRUG Anti-Bacterial Moisturizing Hand Fresh Picked Pomegranates Triclosan SOAP TOPICAL 20130215 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4358_fdea9963-fde2-4a07-85ce-67e16a2ce75d 62670-4358 HUMAN OTC DRUG Anti-Bacterial Gentle Foaming Hand Orchard Walk Triclosan SOAP TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4359_80df395c-0f2c-40dd-be8c-bef48bdb0687 62670-4359 HUMAN OTC DRUG Anti-Bacterial Gentle Foaming Hand I Heart Watermelon Cherry Triclosan SOAP TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4368_8817b124-8cd3-4b91-a5fa-08c3dae70508 62670-4368 HUMAN OTC DRUG Anti-Bacterial Gentle Foaming Hand Cranberry Harvest Triclosan SOAP TOPICAL 20130114 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4369_5066f591-8ec7-4e96-9a5f-b34a9f03ab27 62670-4369 HUMAN OTC DRUG Anti-Bacterial Gentle Foaming Hand Brewberry Triclosan SOAP TOPICAL 20130114 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4383_4da8ce10-3906-4385-b986-db99a21edc82 62670-4383 HUMAN OTC DRUG Anti-Bacterial Gentle Foaming Hand Winter Spice Vanilla Triclosan SOAP TOPICAL 20130114 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4403_fc81ddce-1ff2-4f8b-8c94-4613ad0cb309 62670-4403 HUMAN OTC DRUG Anti-Bacterial Deep Cleansing Hand Papaya Melon Scoop Triclosan SOAP TOPICAL 20130111 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4404_d4e5ad73-b911-462e-8e2c-55d2b901c416 62670-4404 HUMAN OTC DRUG Anti-Bacterial Gentle Foaming Hand Paris Amour Triclosan SOAP TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4405_9025adf5-9e1d-4c13-91ab-8d22ae6cbc11 62670-4405 HUMAN OTC DRUG Anti-Bacterial Gentle Foaming Hand Snow Frosted Apple Triclosan SOAP TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4406_b3f379b3-ddd8-4e08-8c53-6b04df25dd09 62670-4406 HUMAN OTC DRUG Anti-Bacterial Gentle Foaming Hand Vampire Blood Triclosan SOAP TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4407_0834e0ff-4373-4616-b0de-052cbaab8cbf 62670-4407 HUMAN OTC DRUG Anti-Bacterial Gentle Foaming Hand I Heart Watermelon Basil Triclosan SOAP TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4409_4ca4a4e1-faba-4b80-af64-b4edd4b97605 62670-4409 HUMAN OTC DRUG Anti-Bacterial Gentle Foaming Hand Wild Honeysuckle Triclosan SOAP TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4458_3fe09d5b-1474-465d-80d9-9113e7ca4313 62670-4458 HUMAN OTC DRUG Anti-Bacterial Moisturizing Hand Fresh Picked Apricots Triclosan SOAP TOPICAL 20130131 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4562_18d03c27-6cda-4a3f-a39b-f7e993514676 62670-4562 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Japanese Cherry Blossom Alcohol GEL TOPICAL 20130515 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4563_68f72875-5609-4006-bd14-a45f8af6e890 62670-4563 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Sugar Lemon Fizz Alcohol GEL TOPICAL 20130515 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4564_245cff5b-e7b6-446b-9d32-b3680f7eebdb 62670-4564 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Summer Escape Alcohol GEL TOPICAL 20130515 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4565_0834044d-3d4d-45c2-adec-5955bb398ebb 62670-4565 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Sweet Pea Alcohol GEL TOPICAL 20130515 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4569_c57bf4c2-c4c3-45b6-8a0e-067704764347 62670-4569 HUMAN OTC DRUG Anti-Bacterial Hand Coconut Lime Verbena ALCOHOL SPRAY TOPICAL 20130604 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 72 mL/100mL 62670-4590_c0c76c20-c192-4644-9a53-d053e75caf84 62670-4590 HUMAN OTC DRUG Anti-Bacterial Deep Cleansing Hand Fresh Picked Farmstand Apple Triclosan SOAP TOPICAL 20120724 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4591_c67bebbd-3c58-4628-b9bb-b825343bcc8f 62670-4591 HUMAN OTC DRUG Anti-Bacterial Deep Cleansing Hand Fresh Picked Heirloom Cranberries Triclosan SOAP TOPICAL 20120724 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g 62670-4600_1827eb2f-65ec-4476-bcc4-c444b9dc9daf 62670-4600 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Fresh Strawberries Alcohol GEL TOPICAL 20130726 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4759_eb584507-28cb-45c6-99c3-ade1c8073f77 62670-4759 HUMAN OTC DRUG Anti-Bacterial Hand Fresh Picked Garden Strawberries Alcohol GEL TOPICAL 20140403 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4761_f0384d5d-1c79-4950-bea1-ee7fadb98fb9 62670-4761 HUMAN OTC DRUG Anti-Bacterial Hand Fresh Picked Sweet Tangerines Alcohol GEL TOPICAL 20140403 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4764_7cba3a55-569f-412f-a48a-5209492de4c5 62670-4764 HUMAN OTC DRUG Anti-Bacterial Hand Fresh Picked Market Peach Alcohol GEL TOPICAL 20140403 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4765_617937f0-598a-46b7-b3dd-dfa4f40bca46 62670-4765 HUMAN OTC DRUG Anti-Bacterial Hand Fresh Picked Pink Passion Fruit Alcohol GEL TOPICAL 20140404 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4766_7ecb0181-128a-476a-b6d3-c897b28b2f92 62670-4766 HUMAN OTC DRUG Anti-Bacterial Hand Fresh Picked Meyer Lemon Alcohol GEL TOPICAL 20140404 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4767_8ca192e0-e607-47cc-aa1e-f6cf8a445a8a 62670-4767 HUMAN OTC DRUG Anti-Bacterial Hand Fresh Picked Tuscan Melon Alcohol GEL TOPICAL 20140404 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4778_882bed6d-ed08-432e-9a96-72fb4b63cf45 62670-4778 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Fresh Picked Market Peach Alcohol GEL TOPICAL 20140404 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4790_531869da-4761-4652-99b9-787eb3c6c130 62670-4790 HUMAN OTC DRUG Anti-Bacterial Hand Pumpkin Cupcake Alcohol GEL TOPICAL 20140702 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4791_2ddf633d-8e90-4970-a250-342c9e6cdab3 62670-4791 HUMAN OTC DRUG Anti-Bacterial Hand Fresh Picked Farmstand Apple Alcohol GEL TOPICAL 20140702 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4792_43d32c31-5e50-499c-bcdc-9c842feb8846 62670-4792 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Fresh Tangerines Alcohol GEL TOPICAL 20140702 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4793_1d616ca3-6d5c-47f2-8476-f2d6f824e12a 62670-4793 HUMAN OTC DRUG Anti-Bacterial Hand Pumpkin Pecan Waffles Alcohol GEL TOPICAL 20140702 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4794_b12b4bed-38d0-4742-9845-5c5858a5d8c7 62670-4794 HUMAN OTC DRUG Anti-Bacterial Hand Fresh Picked Sweet Clementine Alcohol GEL TOPICAL 20140702 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4795_8b94f0de-b6e8-4cbc-b176-24a03ccd96bc 62670-4795 HUMAN OTC DRUG Anti-Bacterial Hand Sweet Plum and Verbena Alcohol GEL TOPICAL 20140702 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4796_0e76aa05-0fa8-4c3c-8749-8046ceabe2cb 62670-4796 HUMAN OTC DRUG Anti-Bacterial Hand Brown Sugar and Carrots Alcohol GEL TOPICAL 20140702 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4797_69d6290f-7d11-4adb-82a5-a0207230af22 62670-4797 HUMAN OTC DRUG Anti-Bacterial Hand Pear Wood Cider Alcohol GEL TOPICAL 20140702 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4798_61353419-4fb6-433f-abe8-2ead48e2cbed 62670-4798 HUMAN OTC DRUG Anti-Bacterial Hand Fresh Picked Golden Apricot Alcohol GEL TOPICAL 20140702 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4799_62c78308-f8d7-4cc1-9196-6c96a752402e 62670-4799 HUMAN OTC DRUG Anti-Bacterial Hand Fresh Picked Anjou Pear Alcohol GEL TOPICAL 20140702 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4800_326fe900-0138-47c1-9382-1edc001d45fa 62670-4800 HUMAN OTC DRUG Anti-Bacterial Hand Fresh Picked Vineyard Wildberries Alcohol GEL TOPICAL 20140702 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4801_6d3eafa1-bd10-456a-9c44-81df67c922d9 62670-4801 HUMAN OTC DRUG Anti-Bacterial Hand Pumpkin Spice Latte Alcohol GEL TOPICAL 20140702 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4802_2abc23b1-d237-4580-a3b9-9d657fc93f36 62670-4802 HUMAN OTC DRUG Anti-Bacterial Hand Peach Pecan Cupcake Alcohol GEL TOPICAL 20140702 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4803_413b0c00-3226-4bd5-b577-694007497a0a 62670-4803 HUMAN OTC DRUG Anti-Bacterial Hand Graham Cracker Marshmallow Alcohol GEL TOPICAL 20140702 20150101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4804_c3c53d0f-fc73-4cb8-9e0e-9e029c6be799 62670-4804 HUMAN OTC DRUG Anti-Bacterial Hand Cozy Vanilla Cream Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4805_07d0e3da-9f1a-4953-b5e8-e04e543d000b 62670-4805 HUMAN OTC DRUG Anti-Bacterial Hand Crisp Morning Air Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4806_27e52daa-685a-4dd7-a3c4-d304d7c9472d 62670-4806 HUMAN OTC DRUG Anti-Bacterial Hand Berry Swirl Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4807_0536e333-1900-4401-b737-0c503f7547d0 62670-4807 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Sweet Cinnamon Pumpkin Alcohol GEL TOPICAL 20140730 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4808_8c6f6d79-5c72-4cef-a93b-160e8081c6b1 62670-4808 HUMAN OTC DRUG Anti-Bacterial Hand Sweet Cinnamon Pumpkin Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4809_db0ba4cc-6687-48c0-80e6-fca73ef3ea9b 62670-4809 HUMAN OTC DRUG Anti-Bacterial Hand A Walk In The Woods Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4810_63d01f93-d835-47a4-ba69-c3f58689b821 62670-4810 HUMAN OTC DRUG Anti-Bacterial Hand Weekend Apple Picking Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4811_7b6c3a46-46a3-415d-8e6b-d6c71ac6ff67 62670-4811 HUMAN OTC DRUG Anti-Bacterial Hand Golden Autumn Citrus Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4812_b8a609c5-0abd-42a3-bd5c-2f8dea6c18ea 62670-4812 HUMAN OTC DRUG Anti-Bacterial Hand Orchard Apple Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4813_6006f41f-83cd-4e92-8b2e-9d2fbe0ee0f1 62670-4813 HUMAN OTC DRUG Anti-Bacterial Hand Morning Stroll Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4814_a946791f-4243-4e05-bcc5-26d98bafb5a3 62670-4814 HUMAN OTC DRUG Anti-Bacterial Hand Sugar Maple Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4815_a4c46648-fd59-41d8-9dd0-51006cf904ab 62670-4815 HUMAN OTC DRUG Anti-Bacterial Hand Berry Scary Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4816_177fceb1-3a47-4e47-b052-f9c23ea7e861 62670-4816 HUMAN OTC DRUG Anti-Bacterial Hand Pumpkin Spice Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4817_e3ca0038-916f-4f46-bdc2-8116b288e89f 62670-4817 HUMAN OTC DRUG Anti-Bacterial Hand Wicked Plum Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4818_7574a870-99cc-4350-ad34-52c89d31587b 62670-4818 HUMAN OTC DRUG Anti-Bacterial Hand Electric Raspberry Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4819_56b5ed07-5db7-4310-bbd4-b165dfd01169 62670-4819 HUMAN OTC DRUG Anti-Bacterial Hand Candy Apple Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4820_6d05a08c-52e8-45b7-bdbd-1ac7586d7667 62670-4820 HUMAN OTC DRUG Anti-Bacterial Hand Big Blue Sky Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4821_a039bb9d-699e-4bee-9585-c57c00e42132 62670-4821 HUMAN OTC DRUG Anti-Bacterial Hand Sun Tan Summer Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4822_98419e35-07e1-45f4-84bf-b00568037668 62670-4822 HUMAN OTC DRUG Anti-Bacterial Hand Florida Orange Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4823_11e72181-7f06-43b1-84fc-225c688ac788 62670-4823 HUMAN OTC DRUG Anti-Bacterial Hand Pomegranate Alcohol GEL TOPICAL 20140729 20150201 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4824_9be7ec65-a4be-4c2a-a962-e236f60d27df 62670-4824 HUMAN OTC DRUG Anti-Bacterial Hand Vanilla Bean Noel Alcohol GEL TOPICAL 20121206 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4825_f68c7ec3-629d-4ffd-bbd7-6e6d4597a94b 62670-4825 HUMAN OTC DRUG Anti-Bacterial Hand Winter Candy Apple Alcohol GEL TOPICAL 20121206 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4826_d2bc1295-3653-4b24-8129-52d7bbb93b03 62670-4826 HUMAN OTC DRUG Anti-Bacterial Hand Twisted Peppermint Alcohol GEL TOPICAL 20121206 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4827_e5c0ace1-68f5-4423-93c8-05da5661a1a3 62670-4827 HUMAN OTC DRUG Anti-Bacterial Hand Winter Cranberry Alcohol GEL TOPICAL 20121206 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4828_3aeb032c-4600-4094-8da4-b529d3c2d419 62670-4828 HUMAN OTC DRUG Anti-Bacterial Hand Snow Kissed Berry Alcohol GEL TOPICAL 20140915 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4829_95fb297b-a73d-4bb0-9800-451cf56cfd50 62670-4829 HUMAN OTC DRUG Anti-Bacterial Hand Iced Gingerbread Alcohol GEL TOPICAL 20140915 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4830_5516441b-0636-48d0-9c1b-0efb87e44df1 62670-4830 HUMAN OTC DRUG Anti-Bacterial Hand Fresh Sparkling Snow Alcohol GEL TOPICAL 20140915 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4831_3fbf743f-09a4-46a5-8fa0-233c8b30896d 62670-4831 HUMAN OTC DRUG Anti-Bacterial Hand Cocoa Mint Alcohol GEL TOPICAL 20140915 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4832_2fe9d43a-600c-4dd0-ad80-4ca61426d8f5 62670-4832 HUMAN OTC DRUG Anti-Bacterial Hand Sugar Plum Dream Alcohol GEL TOPICAL 20140915 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4833_e10f1eda-b119-4f68-9ea9-f0087f59ef18 62670-4833 HUMAN OTC DRUG Anti-Bacterial Hand Iced Blackberries Alcohol GEL TOPICAL 20140915 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4834_60f3b85b-af06-4d67-ad79-d05ed28ab810 62670-4834 HUMAN OTC DRUG Anti-Bacterial Hand White Pear and Fig Alcohol GEL TOPICAL 20140915 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4835_4d0fef23-185e-4fac-9f87-552ea5eae95c 62670-4835 HUMAN OTC DRUG Anti-Bacterial Hand Pumpkin Frost Alcohol GEL TOPICAL 20140915 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4836_b5102b9f-3c3a-4e40-b9e9-2085e5f78464 62670-4836 HUMAN OTC DRUG Anti-Bacterial Hand Winter Citrus Wreath Alcohol GEL TOPICAL 20140915 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4837_0da807d4-17e5-488d-be36-0f956c8984c5 62670-4837 HUMAN OTC DRUG Anti-Bacterial Hand Ginger Snap Alcohol GEL TOPICAL 20140915 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4838_2ec8c91f-673d-4b5d-918b-39752a99afc5 62670-4838 HUMAN OTC DRUG Anti-Bacterial Hand Indonesia Alcohol GEL TOPICAL 20141112 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4839_acef78d3-9007-47e0-ab40-3e2865507764 62670-4839 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Twisted Peppermint Alcohol GEL TOPICAL 20141113 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4840_6a34a8cd-f9a1-44fd-b884-99fe3fcd46b6 62670-4840 HUMAN OTC DRUG Anti-Bacterial Hand Frosted Wonderland Alcohol GEL TOPICAL 20141112 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4842_1f51b7bd-98ff-40ec-9503-fe095fe3d569 62670-4842 HUMAN OTC DRUG Anti-Bacterial Hand Merry Cookie Alcohol GEL TOPICAL 20141112 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4843_3ac29a42-7280-4944-a982-994ad7432f7b 62670-4843 HUMAN OTC DRUG Anti-Bacterial Hand Raspberry Meringue Alcohol GEL TOPICAL 20141112 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4844_9e470ebc-7b7d-470c-9a88-4bcc4a3bf3d2 62670-4844 HUMAN OTC DRUG Anti-Bacterial Hand Salted Caramel Alcohol GEL TOPICAL 20141112 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4845_17923b4b-fa6c-498c-a26c-7ba90bcddab2 62670-4845 HUMAN OTC DRUG Anti-Bacterial Hand Sweet Cherry Alcohol GEL TOPICAL 20141112 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4846_430d9697-0863-47ce-81b5-68f2ecb98fd1 62670-4846 HUMAN OTC DRUG Anti-Bacterial Hand Apple Wreath Alcohol GEL TOPICAL 20141112 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4847_78c4080d-bec8-4a77-9fdf-dfcc8e36a4b9 62670-4847 HUMAN OTC DRUG Anti-Bacterial Hand Sugared Strawberries Alcohol GEL TOPICAL 20141112 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4848_29355173-8def-4ae4-a480-7cb0c1c2cdd3 62670-4848 HUMAN OTC DRUG Anti-Bacterial Hand Winter Bloom Alcohol GEL TOPICAL 20141112 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4849_517d351c-578e-417c-8a44-16adc0afcdc7 62670-4849 HUMAN OTC DRUG Anti-Bacterial Hand Marshmallow Alcohol GEL TOPICAL 20141112 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4850_36906d43-da22-401b-a72e-2a47d2376cc2 62670-4850 HUMAN OTC DRUG Anti-Bacterial Hand Vanilla Cookie Alcohol GEL TOPICAL 20141114 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4851_f8420077-1c97-4825-82cc-ac7dc98e7d52 62670-4851 HUMAN OTC DRUG Anti-Bacterial Hand Mahogany Teakwood Alcohol GEL TOPICAL 20141114 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4852_e54c38db-f9d3-4eae-ad5c-67d9ae432a52 62670-4852 HUMAN OTC DRUG Anti-Bacterial Hand Tis The Season Alcohol GEL TOPICAL 20141114 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4853_67ca4458-95c9-4367-ba21-cf3dd92a081f 62670-4853 HUMAN OTC DRUG Anti-Bacterial Hand Winter Alcohol GEL TOPICAL 20141114 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4854_90789ea1-5c77-4d76-8fe9-3e89f394309d 62670-4854 HUMAN OTC DRUG Anti-Bacterial Hand Mad About You Alcohol GEL TOPICAL 20141114 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4855_60a925d2-ca1f-479a-ac89-ddc344efb46a 62670-4855 HUMAN OTC DRUG Anti-Bacterial Hand Macau Alcohol GEL TOPICAL 20141114 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4856_bca48b8f-3c2e-4356-bbd2-8ed3aadf4120 62670-4856 HUMAN OTC DRUG Anti-Bacterial Hand Malaysia Alcohol GEL TOPICAL 20141114 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4857_af2b4643-dfc6-46ac-82eb-7022f1869faf 62670-4857 HUMAN OTC DRUG Anti-Bacterial Hand Candy Cane Bliss Alcohol GEL TOPICAL 20141114 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4858_21b64ab7-3570-4124-b8a0-bd1337e5790f 62670-4858 HUMAN OTC DRUG Anti-Bacterial Hand Cocktails and Confetti Alcohol GEL TOPICAL 20141114 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4859_e8d521b1-34fa-4ce1-8f61-72845cf987f3 62670-4859 HUMAN OTC DRUG Anti-Bacterial Hand Kiss Kiss Mistletoe Alcohol GEL TOPICAL 20141114 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4860_a6867c13-e357-4b03-b531-3ed018dbbc57 62670-4860 HUMAN OTC DRUG Anti-Bacterial Hand Lemon Meringue Cheer Alcohol GEL TOPICAL 20141114 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-4861_18226aa9-f6a0-4800-9ff0-6ccb7769b346 62670-4861 HUMAN OTC DRUG Anti-Bacterial Hand Love Peach and Joy Alcohol GEL TOPICAL 20141114 20150630 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL 62670-8042_06fb849a-304a-4406-9c1f-cbb68cc7872b 62670-8042 HUMAN OTC DRUG Patricia Wexler Skin Brightening Daily Moisturizer with Sunscreen Broad Spectrum SPF 28 Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130828 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 1.8; 7.5; 5; 2.4 g/100mL; g/100mL; g/100mL; g/100mL 62670-8043_14af5e69-d00b-411b-8274-df6eab3a49c3 62670-8043 HUMAN OTC DRUG Patricia Wexler Universal Anti-Aging Moisturizer with Sunscreen Broad Spectrum SPF 28 Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130828 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 1.8; 7.5; 5; 2.4 g/100mL; g/100mL; g/100mL; g/100mL 62670-8045_e11ecd4c-2f66-4d34-afd0-cd858cbc1376 62670-8045 HUMAN OTC DRUG Signature Sunscreen Broad Spectrum SPF 25 Malibu Heat Avobenzone, Octinoxate, Oxybenzone LOTION TOPICAL 20130909 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE 3; 7.5; 6 g/100mL; g/100mL; g/100mL 62670-8046_90ac3b6a-ce75-4a98-9d31-7a706b7572ad 62670-8046 HUMAN OTC DRUG True Blue Spa Cooling Sunscreen Mist Broad Spectrum SPF 25 Water Resistant (40 minutes) Monoi Oil Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20130930 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13.5; 7.5; 4.6; 2.4; 6 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g 62670-8047_d855965d-f5bf-4334-99a1-2c6025dd7fb0 62670-8047 HUMAN OTC DRUG Patricia Wexler Intensive 3-in-1 Day Cream with Sunscreen Broad Spectrum SPF 28 Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20130930 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.7; 4 mg/g; mg/g; mg/g; mg/g; mg/g 62672-221_ba9856d4-dece-4ee7-b350-3d9d140eede3 62672-221 HUMAN OTC DRUG Tampa General Hospital Instant Hand Degermer ALCOHOL GEL TOPICAL 20061101 OTC MONOGRAPH NOT FINAL part333 Osceola Supply, Inc. ALCOHOL .7 mL/mL 62672-608_70c2009d-179d-4815-8559-33f2c088e758 62672-608 HUMAN OTC DRUG Sani ALCOHOL GEL TOPICAL 20030701 OTC MONOGRAPH NOT FINAL part333E Osceola Supply, Inc. ALCOHOL .7 mL/mL 62678-206_4d732bef-4ecc-41e4-8965-8ef07a330395 62678-206 HUMAN OTC DRUG Dental plus Extra Menta SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20100519 OTC MONOGRAPH FINAL part355 Tropical International Manufacturing Inc SODIUM MONOFLUOROPHOSPHATE 8 mg/g 62678-207_4321f703-7907-4dbe-988f-aab8ab236978 62678-207 HUMAN OTC DRUG Dental plus Baking Soda SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20100519 OTC MONOGRAPH FINAL part355 Tropical International Manufacturing Inc SODIUM MONOFLUOROPHOSPHATE 8 mg/g 62678-216_d7743258-adbd-4b4b-a382-5479f0e640e4 62678-216 HUMAN OTC DRUG Dental plus Whitening SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20100519 OTC MONOGRAPH FINAL part355 Tropical International Manufacturing Inc SODIUM MONOFLUOROPHOSPHATE 8 mg/g 62678-217_07e7c00b-174e-4de7-99c2-10c5533183b1 62678-217 HUMAN OTC DRUG Dental plus Regular Flavor SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20100519 OTC MONOGRAPH FINAL part355 Tropical International Manufacturing Inc SODIUM MONOFLUOROPHOSPHATE 8 mg/g 62695-1001_cab51b1d-a07b-4249-a146-bde1ddb992da 62695-1001 HUMAN OTC DRUG Any Mi Natural Magic BB No.5 ALLANTOIN CREAM TOPICAL 20140315 OTC MONOGRAPH FINAL part347 K.N.Life Co., Ltd. ALLANTOIN .0005 g/mL 62695-2001_cf71be34-af09-46c1-bc02-31815719ee3d 62695-2001 HUMAN OTC DRUG Any Mi Natural Magic BB No.7 ALLANTOIN CREAM TOPICAL 20140315 OTC MONOGRAPH FINAL part347 K.N.Life Co., Ltd. ALLANTOIN .0005 g/mL 62699-1112_25e0da6b-c77e-4925-a8f7-6c54508eacd3 62699-1112 HUMAN OTC DRUG Golden Sunshine Far Infrared HOT Herbal Topical Analgesic PATCH TOPICAL 20040802 OTC MONOGRAPH NOT FINAL part348 Nan Mei Pharmaceutical Co., Ltd. MENTHOL; METHYL SALICYLATE .03; .005 g/g; g/g 62699-1114_c4a36e62-44f6-4398-a66e-c79a60938ca4 62699-1114 HUMAN OTC DRUG Golden Sunshine Herbal Topical Analgesic SPRAY TOPICAL 20040802 OTC MONOGRAPH NOT FINAL part348 Nan Mei Pharmaceutical Co., Ltd. MENTHOL; METHYL SALICYLATE .00781; .03 g/g; g/g 62699-1123_e71c9ccb-ba4d-4c83-b7c8-a2f969a35831 62699-1123 HUMAN OTC DRUG Golden Sunshine Herbal Topical Analgesic CREAM TOPICAL 20100615 OTC MONOGRAPH NOT FINAL part348 Nan Mei Pharmaceutical Co., Ltd. MENTHOL; METHYL SALICYLATE .02; .005 g/g; g/g 62699-2211_96a94ddd-3e78-48f1-909a-9f6c3eff7eec 62699-2211 HUMAN OTC DRUG Golden Sunshine Far Infrared Herbal Topical Analgesic PASTE TOPICAL 20090223 OTC MONOGRAPH NOT FINAL part348 Nan Mei Pharmaceutical Co., Ltd. MENTHOL; METHYL SALICYLATE .03; .03 g/g; g/g 62699-2212_c75b8056-b709-461d-b9ff-f35b0fd166e1 62699-2212 HUMAN OTC DRUG Golden Sunshine Far Infrared COOL Herbal Topical Analgesic PATCH TOPICAL 20040802 OTC MONOGRAPH NOT FINAL part348 Nan Mei Pharmaceutical Co., Ltd. MENTHOL; METHYL SALICYLATE .03; .005 g/g; g/g 62699-3312_32ec8693-cf32-4155-b08e-dba0b84cbca1 62699-3312 HUMAN OTC DRUG PAIN Terminator Analgesic Topical Analgesic PATCH TOPICAL 20060518 OTC MONOGRAPH NOT FINAL part348 Nan Mei Pharmaceutical Co., Ltd. MENTHOL; METHYL SALICYLATE .03; .005 g/g; g/g 62699-3313_ce5e00d1-2767-491b-8b11-2e687045faf6 62699-3313 HUMAN OTC DRUG PAIN Terminator Analgesic Topical Analgesic CREAM TOPICAL 20090223 OTC MONOGRAPH NOT FINAL part348 Nan Mei Pharmaceutical Co., Ltd. MENTHOL; METHYL SALICYLATE .02; .005 g/g; g/g 62712-221_4f76a1ca-05da-4535-ab8f-4bfd76188147 62712-221 HUMAN OTC DRUG Free Hand ALCOHOL GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333E Atco International ALCOHOL .7 mL/mL 62712-575_c8baa644-5165-4b19-a6bd-636d71b6bec6 62712-575 HUMAN OTC DRUG Handi-San BENZETHONIUM CHLORIDE LIQUID TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333E Atco International BENZETHONIUM CHLORIDE 2 mg/mL 62713-801_61aa75c4-7524-4ceb-9419-ae603184fbcf 62713-801 HUMAN OTC DRUG Allergena Zone 1 Echinacea, Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Zone 1 Tree, Zone 1 Weed, Zone 1 Grass LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ACER NEGUNDO POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA VULGARIS POLLEN; AVENA SATIVA POLLEN; BAPTISIA TINCTORIA ROOT; BETULA NIGRA POLLEN; BETULA POPULIFOLIA POLLEN; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARYA TOMENTOSA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA, UNSPECIFIED; FAGUS GRANDIFOLIA POLLEN; FENUGREEK LEAF; FESTUCA PRATENSIS TOP; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GOLDENSEAL; HOLCUS LANATUS POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOELERIA MACRANTHA POLLEN; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; MYRRH; NASTURTIUM OFFICINALE; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PICEA PUNGENS POLLEN; PINUS STROBUS POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES POLLEN; QUERCUS ALBA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SOLIDAGO CANADENSIS POLLEN; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII POLLEN; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN; ZEA MAYS POLLEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 3; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 3; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-802_cfede728-6054-47fd-83f2-3494f02bf3de 62713-802 HUMAN OTC DRUG Allergena Zone 2 Echinacea,Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Zone 2 Tree, Zone 2 Weed, Zone 2 Grass LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA VULGARIS POLLEN; BACCHARIS HALIMIFOLIA POLLEN; BAPTISIA TINCTORIA ROOT; BETULA OCCIDENTALIS POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA, UNSPECIFIED; FENUGREEK LEAF; FESTUCA PRATENSIS POLLEN; FRAXINUS PENNSYLVANICA POLLEN; GOLDENSEAL; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM PERENNE POLLEN; MORUS RUBRA POLLEN; MYRRH; NASTURTIUM OFFICINALE; PASPALUM NOTATUM POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS STROBUS POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; TAXODIUM DISTICHUM POLLEN; ULMUS AMERICANA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 3; 3; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 3; 3; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-803_f1a79743-e62b-4022-8171-6dd683743c9b 62713-803 HUMAN OTC DRUG Allergena Zone 3 Echinacea,Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Zone 3 Tree, Zone 3 Weed, Zone 3 Grass LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ACER NEGUNDO POLLEN; ACER SACCHARUM POLLEN; AILANTHUS ALTISSIMA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; AMPHIACHYRIS DRACUNCULOIDES POLLEN; ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA LUDOVICIANA POLLEN; ARTEMISIA TRIDENTATA POLLEN; AVENA SATIVA POLLEN; BAPTISIA TINCTORIA ROOT; BETULA OCCIDENTALIS POLLEN; BETULA PAPYRIFERA POLLEN; BROMUS INERMIS POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA, UNSPECIFIED; FAGUS GRANDIFOLIA POLLEN; FENUGREEK LEAF; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GOLDENSEAL; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOELERIA MACRANTHA POLLEN; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; MYRRH; NASTURTIUM OFFICINALE; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS STROBUS POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES POLLEN; QUERCUS ALBA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SOLIDAGO CANADENSIS POLLEN; SORGHUM BICOLOR POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 3; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 3; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-805_fc1a6312-d410-428a-8d07-bfe7f47fcbe9 62713-805 HUMAN OTC DRUG Allergena Trees, Weeds and Grasses - Zone 5 Kids Allergena Trees, Weeds and Grasses - Zone 5 Kids LIQUID ORAL 20111010 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; AMPHIACHYRIS DRACUNCULOIDES POLLEN; ARRHENATHERUM ELATIUS POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA DRACUNCULUS POLLEN; ARTEMISIA FRIGIDA POLLEN; ARTEMISIA LUDOVICIANA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA POLLEN; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA POPULIFOLIA POLLEN; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CARYA TOMENTOSA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA ANGUSTIFOLIA; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FENUGREEK SEED; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GOLDENSEAL; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOELERIA MACRANTHA POLLEN; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; MYRRH; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PICEA PUNGENS POLLEN; PINUS NIGRA POLLEN; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS ALBA POLLEN; QUERCUS KELLOGGII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS STELLATA POLLEN; RORIPPA NASTURTIUM-AQUATICUM; RUMEX CRISPUS POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SALSOLA TRAGUS POLLEN; SOLIDAGO CANADENSIS POLLEN; SORGHUM BICOLOR POLLEN; SORGHUM BICOLOR SUBSP. DRUMMONDII POLLEN; SORGHUM HALEPENSE POLLEN; TAXODIUM DISTICHUM POLLEN; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 3; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-806_18f85599-ab13-4574-8e3e-ce20c10ab83e 62713-806 HUMAN OTC DRUG Allergena Trees, Weeds and Grasses - Zone 6 Allergena Trees, Weeds and Grasses - Zone 6 LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ACACIA POLLEN; ACER NEGUNDO POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; AMPHIACHYRIS DRACUNCULOIDES POLLEN; ARRHENATHERUM ELATIUS POLLEN; ARTEMISIA DRACUNCULUS POLLEN; ARTEMISIA FRIGIDA POLLEN; ARTEMISIA LUDOVICIANA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN; ATRIPLEX CONFERTIFOLIA POLLEN; ATRIPLEX POLYCARPA POLLEN; ATRIPLEX WRIGHTII POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA POLLEN; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BROMUS INERMIS POLLEN; CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA ANGUSTIFOLIA; ELYMUS REPENS POLLEN; FENUGREEK SEED; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GOLDENSEAL; JUNIPERUS OCCIDENTALIS POLLEN; KOELERIA MACRANTHA POLLEN; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; MYRRH; OLEA EUROPAEA POLLEN; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS NIGRA POLLEN; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA ANNUA POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS ALBA POLLEN; RORIPPA NASTURTIUM-AQUATICUM; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SOLIDAGO CANADENSIS POLLEN; SORGHUM BICOLOR POLLEN; SORGHUM BICOLOR SUBSP. DRUMMONDII POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 3; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-807_ffb46316-7af0-4b6e-9144-72c6130dd45f 62713-807 HUMAN OTC DRUG Allergena Zone 7 Echinacea,Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Zone 7 Tree, Zone 7 Weed, Zone 7 Grass LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ACER NEGUNDO POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA LUDOVICIANA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ATRIPLEX CANESCENS POLLEN; ATRIPLEX CONFERTIFOLIA POLLEN; AVENA SATIVA POLLEN; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; BROMUS INERMIS POLLEN; CARYA TOMENTOSA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA, UNSPECIFIED; FAGUS GRANDIFOLIA POLLEN; FENUGREEK LEAF; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; GOLDENSEAL; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOELERIA MACRANTHA POLLEN; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; MYRRH; NASTURTIUM OFFICINALE; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PICEA PUNGENS POLLEN; PINUS STROBUS POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES POLLEN; QUERCUS VIRGINIANA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SALSOLA TRAGUS POLLEN; SOLIDAGO CANADENSIS POLLEN; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII POLLEN; TRITICUM AESTIVUM POLLEN; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 3; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 3; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-808_5b445509-db53-4060-9871-83a996a374e3 62713-808 HUMAN OTC DRUG Allergena Zone 8 Echinacea,Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Zone 8 Tree, Zone 8 Weed, Zone 8 Grass LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ACER RUBRUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALNUS RUBRA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA LUDOVICIANA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN; ATRIPLEX CANESCENS POLLEN; ATRIPLEX CONFERTIFOLIA POLLEN; AVENA SATIVA POLLEN; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; BROMUS INERMIS POLLEN; CARYA TOMENTOSA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA, UNSPECIFIED; FAGUS GRANDIFOLIA POLLEN; FENUGREEK LEAF; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; GOLDENSEAL; IVA ANNUA POLLEN; JUGLANS REGIA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MYRRH; NASTURTIUM OFFICINALE; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PICEA PUNGENS POLLEN; PINUS STROBUS POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS NIGRA POLLEN; POPULUS TREMULOIDES POLLEN; PSEUDOTSUGA MENZIESII POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SALSOLA TRAGUS POLLEN; SARCOBATUS VERMICULATUS POLLEN; SOLIDAGO CANADENSIS POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 3; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 3; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-809_ac74531e-dbaa-4bf8-b8fc-faa319b37413 62713-809 HUMAN OTC DRUG Allergena Zone 9 Echinacea,Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Zone 9 Tree, Zone 9 Weed, Zone 9 Grass LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ACACIA POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ATRIPLEX CANESCENS POLLEN; BAPTISIA TINCTORIA ROOT; BROMUS INERMIS POLLEN; BROMUS SECALINUS POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA, UNSPECIFIED; EUCALYPTUS GLOBULUS POLLEN; FENUGREEK LEAF; FESTUCA PRATENSIS POLLEN; FRAXINUS VELUTINA POLLEN; GOLDENSEAL; JUGLANS NIGRA POLLEN; JUNIPERUS SCOPULORUM POLLEN; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MYRRH; NASTURTIUM OFFICINALE; OLEA EUROPAEA POLLEN; PHLEUM PRATENSE POLLEN; PHOENIX DACTYLIFERA POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS STROBUS POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS AGRIFOLIA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SALSOLA TRAGUS POLLEN; SORGHUM HALEPENSE POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 3; 30; 3; 30; 30; 3; 30; 30; 30; 30; 30; 30; 3; 3; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-810_cff9007b-ce8b-4512-93a4-39dbfdc1aee6 62713-810 HUMAN OTC DRUG Allergena Hawaii, Puerto Rico and the Virgin Islands Echinacea, Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Tropical Tree, Tropical Weed, Tropical Grass LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ACACIA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; ALNUS RUBRA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA VULGARIS POLLEN; BAPTISIA TINCTORIA ROOT; BROUSSONETIA PAPYRIFERA POLLEN; CHENOPODIUM ALBUM POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA, UNSPECIFIED; EUCALYPTUS GLOBULUS POLLEN; FENUGREEK LEAF; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GOLDENSEAL; JUGLANS NIGRA POLLEN; LIGUSTRUM VULGARE POLLEN; LOLIUM PERENNE POLLEN; MORELLA CERIFERA POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; MYRRH; NASTURTIUM OFFICINALE; PASPALUM NOTATUM POLLEN; PHOENIX DACTYLIFERA POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS STROBUS POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SORGHUM HALEPENSE POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 3; 30; 3; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 3; 3; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-811_d60e6c17-710c-450f-8467-9004e6566119 62713-811 HUMAN OTC DRUG Allergena Mold Mix Echinacea, Baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-Graecum, Acremonium, Alternaria Tenuis, Aspergillus Mixture, Aureobasidium, Botrytis Cinerea, Chaetomium Globosum, Cladosporium Cladosporioides, Curvularia, Drechslera, Epicoccum Nigrum, Fusarium, Mucor, Neurospora, Nigrospora, Penicillium Mixture, Phoma Herbarum, Rhizopus, Rhodotorula Rubra, Stemphylium, Torula Cerevisiae, Trichoderma Lignorum, Trichophyton Mentagrophytes LIQUID ORAL 19990101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ACREMONIUM STRICTUM; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BAPTISIA TINCTORIA ROOT; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SPICIFER; ECHINACEA, UNSPECIFIED; EPICOCCUM NIGRUM; FENUGREEK LEAF; GOLDENSEAL; HAEMATONECTRIA HAEMATOCOCCA; KHUSKIA ORYZAE; MUCOR PLUMBEUS; MYRRH; NASTURTIUM OFFICINALE; NEUROSPORA SITOPHILA; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA EXIGUA VAR. EXIGUA; PHYTOLACCA AMERICANA ROOT; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; STEMPHYLIUM SARCINIFORME; TRICHODERMA VIRIDE; TRICHOPHYTON MENTAGROPHYTES 30; 30; 30; 30; 3; 30; 30; 30; 30; 3; 30; 3; 3; 30; 30; 30; 3; 3; 30; 30; 30; 3; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-812_ff08743a-00cd-4457-bf98-6b356f65f40d 62713-812 HUMAN OTC DRUG Allergena Dust Plus Mite Echinacea, Baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-Graecum, Blatta Orientalis (Oriental Cockroach) HPUS, Dust Mite (D.Pteronyssinus, D. Farinae), Grain Dust (Barley, Corn, Millet, Oat, Rice, Wheat), House Dust (Mattress, Rug, Upholstery), Periplaneta Americana, Stannum Metallicum LIQUID ORAL 19990101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations BAPTISIA TINCTORIA ROOT; BARLEY; BLATTA ORIENTALIS; BROWN RICE; CORN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; ECHINACEA, UNSPECIFIED; FENUGREEK LEAF; GOLDENSEAL; HOUSE DUST; MILLET; MYRRH; NASTURTIUM OFFICINALE; OAT; PERIPLANETA AMERICANA; PHYTOLACCA AMERICANA ROOT; TIN; WHEAT BRAN 3; 30; 30; 30; 30; 30; 30; 3; 3; 3; 30; 30; 3; 3; 30; 30; 3; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-814_bd83d0ad-8a68-4b22-a65f-7ec8e71dbf4b 62713-814 HUMAN OTC DRUG Allergena Fragrance Allergena Fragrance LIQUID ORAL 20120901 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ACTIVATED CHARCOAL; ARNICA MONTANA; CICUTA VIROSA ROOT; EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; KEROSENE; LEAD; LYCOPERDON UTRIFORME FRUITING BODY; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SULFUR 8; 6; 6; 6; 4; 6; 8; 6; 8; 8; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-815_2a8a8492-298c-4299-926c-8b81a4e8a044 62713-815 HUMAN OTC DRUG Progena Lyme Disease Avena sativa, Carduus marianus, Scrophularia nodosa, Solidago virgaurea, Arsenicum album, Cina, Conium maculatum, Gelsemium sempervirens, Lycopodium clavatum, Mercuris vivus, Phosphoricum acidum, Phosphorus, Selenium metallicum LIQUID ORAL 19850101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ARSENIC TRIOXIDE; ARTEMISIA CINA PRE-FLOWERING TOP; AVENA SATIVA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORIC ACID; PHOSPHORUS; SCROPHULARIA NODOSA; SELENIUM; SILYBUM MARIANUM SEED; SOLIDAGO VIRGAUREA FLOWERING TOP 30; 30; 3; 30; 30; 30; 30; 30; 30; 3; 30; 3; 3 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 62713-816_a15f84d5-f797-4c3c-be2d-098e38f8ebed 62713-816 HUMAN OTC DRUG Allergena Texas Trees Kids Echinacea,Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Texas Tree, Texas Weed, Texas Grass LIQUID ORAL 20110101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; AMPHIACHYRIS DRACUNCULOIDES POLLEN; ARRHENATHERUM ELATIUS POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA FRIGIDA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA POLLEN; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARYA CORDIFORMIS POLLEN; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA OVATA POLLEN; CARYA TOMENTOSA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FENUGREEK LEAF; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GOLDENSEAL; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOELERIA MACRANTHA POLLEN; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; MYRRH; NASTURTIUM OFFICINALE; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PICEA PUNGENS POLLEN; PINUS NIGRA POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS NIGRA POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS ALBA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA POLLEN; RUMEX CRISPUS POLLEN; RUMEX CRISPUS POLLEN; RUMEX OBTUSIFOLIUS POLLEN; SALIX NIGRA POLLEN; SALSOLA TRAGUS POLLEN; SOLIDAGO CANADENSIS POLLEN; SORGHUM BICOLOR POLLEN; SORGHUM BICOLOR SUBSP. DRUMMONDII POLLEN; SORGHUM HALEPENSE POLLEN; TAXODIUM DISTICHUM POLLEN; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 3; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 3; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-817_d91641de-dbdf-44c2-bc24-9385c3c0d7dc 62713-817 HUMAN OTC DRUG Allergena Zone 4 Echinacea,Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Zone 4 Tree, Zone 4 Weed, Zone 4 Grass LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; AMPHIACHYRIS DRACUNCULOIDES POLLEN; ARRHENATHERUM ELATIUS POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA FRIGIDA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA POLLEN; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARYA CORDIFORMIS POLLEN; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA OVATA POLLEN; CARYA TOMENTOSA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FENUGREEK LEAF; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GOLDENSEAL; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOELERIA MACRANTHA POLLEN; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; MYRRH; NASTURTIUM OFFICINALE; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PICEA PUNGENS POLLEN; PINUS NIGRA POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS NIGRA POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS ALBA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA POLLEN; RUMEX CRISPUS POLLEN; RUMEX CRISPUS POLLEN; RUMEX OBTUSIFOLIUS POLLEN; SALIX NIGRA POLLEN; SALSOLA TRAGUS POLLEN; SOLIDAGO CANADENSIS POLLEN; SORGHUM BICOLOR POLLEN; SORGHUM BICOLOR SUBSP. DRUMMONDII POLLEN; SORGHUM HALEPENSE POLLEN; TAXODIUM DISTICHUM POLLEN; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 3; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 3; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-818_810e7739-0f21-4e8f-bcad-a689ebc9290a 62713-818 HUMAN OTC DRUG Allergena Texas Cedar Fever Echinacea,Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Texas Tree, Texas Weed, Texas Grass LIQUID ORAL 20110101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; AMPHIACHYRIS DRACUNCULOIDES POLLEN; ARRHENATHERUM ELATIUS POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA FRIGIDA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS POLLEN; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA POLLEN; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARYA CORDIFORMIS POLLEN; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA OVATA POLLEN; CARYA TOMENTOSA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FENUGREEK LEAF; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GOLDENSEAL; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS VIRGINIANA POLLEN; KOELERIA MACRANTHA POLLEN; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MORUS ALBA POLLEN; MORUS RUBRA POLLEN; MYRRH; NASTURTIUM OFFICINALE; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PICEA PUNGENS POLLEN; PINUS NIGRA POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS NIGRA POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS ALBA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA POLLEN; RUMEX CRISPUS POLLEN; RUMEX OBTUSIFOLIUS POLLEN; SALIX NIGRA POLLEN; SALSOLA TRAGUS POLLEN; SOLIDAGO CANADENSIS POLLEN; SORGHUM BICOLOR POLLEN; SORGHUM BICOLOR SUBSP. DRUMMONDII POLLEN; SORGHUM HALEPENSE POLLEN; TAXODIUM DISTICHUM POLLEN; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 3; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 3; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-911_af107fb5-c0d4-4b7d-bcc1-ae32163d56c6 62713-911 HUMAN OTC DRUG Progena Lung Plus Phellandrium aquaticum, Rumex crispus, Sambucus nigra, Senega officinalis, Lung, Arsenicum album, Carbo vegetabilis, Drosera rotundifolia, Ipecacuanha, Phosphorus, Pulsatilla, Silicea, Sulphur LIQUID ORAL 19850101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ACTIVATED CHARCOAL; ARSENIC TRIOXIDE; DROSERA ROTUNDIFOLIA; IPECAC; OENANTHE AQUATICA FRUIT; PHOSPHORUS; POLYGALA SENEGA ROOT; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SILICON DIOXIDE; SULFUR; SUS SCROFA LUNG 30; 30; 30; 30; 3; 30; 3; 30; 3; 3; 30; 30; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 62713-914_0792dbd0-3b4a-449f-949b-bd0e21fbb74b 62713-914 HUMAN OTC DRUG Progena Pancreas Plus Acidum Phosphoricum, Berberis Vulgaris, Bilberry, Cheidonium Majus, Creosotum, Kidney, Natrum sulpuricum, Pancreas, Syzygium Jambolanum LIQUID ORAL 19850101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations BERBERIS VULGARIS ROOT BARK; BILBERRY; CHELIDONIUM MAJUS; PHOSPHORIC ACID; PORK KIDNEY; SODIUM SULFATE; SUS SCROFA PANCREAS; SYZYGIUM CUMINI SEED; WOOD CREOSOTE 2; 2; 4; 4; 6; 6; 6; 10; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-915_b978c066-140f-46ba-ada6-44f4e45e9b68 62713-915 HUMAN OTC DRUG Progena Thyro Plus Calcarea Iodata, Fucus Vesiculosus, Glandula Suprarenalis, Kali Iodatum, Pituitary, Spleen, Spongia Tosta, Thymus, Thyroidinum, Calcarea Carbonica, Ferrum Iodatum, Hepar Sulphuris Calcareum, Lapis Albus LIQUID ORAL 19850101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations CALCIUM HEXAFLUOROSILICATE; CALCIUM IODIDE; CALCIUM SULFIDE; FERROUS IODIDE; FUCUS VESICULOSUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM IODIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; THYROID, UNSPECIFIED 8; 4; 8; 8; 6; 8; 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-917_a91240b5-ccaa-49b3-ae35-3dd1856273b6 62713-917 HUMAN OTC DRUG Progena Thymus Plus Arsenicum Album, Belladonna, Calcarea Fluorica, Calcarea Sulphurica, Echinacea, Hepar Sulphuris Calcareum, Lachesis Mutus, Nux Moschata, Silicea, Sulphur Iodatum, Thymus Gland LIQUID ORAL 19850101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ARSENIC TRIOXIDE; ATROPA BELLADONNA; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; CALCIUM SULFIDE; ECHINACEA ANGUSTIFOLIA; LACHESIS MUTA VENOM; NUTMEG; SILICON DIOXIDE; SULFUR IODIDE; SUS SCROFA THYMUS 6; 6; 8; 8; 8; 1; 12; 3; 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-918_98922b1d-a436-49c6-857e-13392b351923 62713-918 HUMAN OTC DRUG Progena Pituitary Plus Adrenalinum, Arnica montana, Erigeron canadensis, Hydrastis canadensis, Millefolium, Pituitary, Sabina, Secale cornutum LIQUID ORAL 19850101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ACHILLEA MILLEFOLIUM; ARNICA MONTANA; CLAVICEPS PURPUREA SCLEROTIUM; CONYZA CANADENSIS; EPINEPHRINE; GOLDENSEAL; JUNIPERUS SABINA LEAFY TWIG; SUS SCROFA PITUITARY GLAND 6; 6; 8; 6; 6; 6; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-921_9a76c289-94c3-4b8d-a4e5-985186ee0704 62713-921 HUMAN OTC DRUG Progena Adrenal Plus Atropinum Sulphuricum, Berberis Vulgaris, Bryonia, Carduus Marianus, Chelidonium Majus, Echinacea, Glandula Suprarenalis, Lycopodium Clavatum, Magnesia Phosphorica, Spleen, Zingiber Officinale LIQUID ORAL 19850101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ATROPINE SULFATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; GINGER; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILYBUM MARIANUM SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA SPLEEN 6; 3; 4; 3; 2; 2; 12; 8; 2; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-925_e16dd328-31c2-4fa6-85a8-4e181756b8f0 62713-925 HUMAN OTC DRUG Candicide 12X Candicide 12X LIQUID ORAL 19840301 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations BAPTISIA TINCTORIA ROOT; CANDIDA ALBICANS; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM BORATE; STRYCHNOS NUX-VOMICA SEED; WOOD CREOSOTE 3; 12; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-930_221fbcd3-aab3-43c5-a339-2cecd316cca7 62713-930 HUMAN OTC DRUG Candicide Candicide LIQUID ORAL 20141010 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations BAPTISIA TINCTORIA ROOT; CANDIDA ALBICANS; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM BORATE; STRYCHNOS NUX-VOMICA SEED; WOOD CREOSOTE 3; 500; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-940_8162cb20-4bef-459e-a176-3062d13ec5fd 62713-940 HUMAN OTC DRUG Progena Immugen Aralia Quinquefolia, Echinacea, Phytolacca Decandra, Ascorbic Acid, Beta Carotene, Glandula Suprarenalis, Pyridoxinum Hydrochloricum, Spleen, Thymus, Selenium Metallicum, Vitamin E, Zincum Metallicum LIQUID ORAL 19850101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations .ALPHA.-TOCOPHEROL; .BETA.-CAROTENE; AMERICAN GINSENG; ASCORBIC ACID; ECHINACEA, UNSPECIFIED; PHYTOLACCA AMERICANA ROOT; PYRIDOXINE HYDROCHLORIDE; SELENIUM; SUS SCROFA ADRENAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; ZINC 8; 6; 3; 6; 3; 3; 6; 8; 6; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-941_f5b6c281-3aa3-473b-86ce-fa44a85b0325 62713-941 HUMAN OTC DRUG Progena Attention Span Anacardium orientale, Calcarea phosphorica, Carcinosin, Iodium, Stramonium, Tarentula hispana, Veratrum album LIQUID ORAL 19900101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations DATURA STRAMONIUM; HUMAN BREAST TUMOR CELL; IODINE; LYCOSA TARANTULA; SEMECARPUS ANACARDIUM JUICE; TRIBASIC CALCIUM PHOSPHATE; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 62713-942_98bd9705-7af7-43d7-8516-80ab61832b54 62713-942 HUMAN OTC DRUG Allergena Pet Dander Homeopathic Sublingual Immunotherapy LIQUID ORAL 20120801 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations BAPTISIA TINCTORIA; BOS TAURUS ADRENAL GLAND; BOS TAURUS DANDER; CANIS LUPUS FAMILIARIS DANDER; CAVIA PORCELLUS DANDER; CHICKEN; CORTICOTROPIN; DUCK; ECHINACEA ANGUSTIFOLIA; EQUUS CABALLUS DANDER; FELIS CATUS DANDER; FENUGREEK SEED; GOLDENSEAL; GOOSE; HISTAMINE; MAMMAL LIVER; MESOCRICETUS AURATUS SKIN; MUS MUSCULUS SKIN; MYRRH; NASTURTIUM OFFICINALE; ORYCTOLAGUS CUNICULUS SKIN; PHYTOLACCA AMERICANA ROOT; SUS SCROFA DANDER 3; 4; 100; 100; 100; 100; 30; 100; 3; 100; 100; 3; 3; 100; 12; 12; 100; 100; 3; 3; 100; 3; 100 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62713-943_839b8761-0485-482e-a0a7-f1d557f1b7d6 62713-943 HUMAN OTC DRUG Allergena for Pets Allergena for Pets LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ARTEMISIA VULGARIS POLLEN; BAPTISIA TINCTORIA ROOT; BETULA PAPYRIFERA POLLEN; CALENDULA OFFICINALIS FLOWERING TOP; CYNODON DACTYLON POLLEN; DELPHINIUM STAPHISAGRIA SEED; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; ECHINACEA, UNSPECIFIED; FENUGREEK LEAF; GOLDENSEAL; JUNIPERUS ASHEI POLLEN; LOLIUM PERENNE POLLEN; MYRRH; NASTURTIUM OFFICINALE; PASPALUM NOTATUM POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; POA ANNUA POLLEN; QUERCUS RUBRA POLLEN; SALSOLA TRAGUS POLLEN; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 30; 30; 30; 3; 30; 3; 30; 6; 30; 30; 3; 3; 3; 30; 30; 3; 3; 30; 30; 3; 30; 30; 30; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62715-0001_282e1bf8-029c-454b-97d6-53b5c2424769 62715-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19951101 UNAPPROVED MEDICAL GAS Great Plains Homecare Equipment OXYGEN 99 L/100L 62716-665_336b2102-60b2-4863-b54a-84d697706391 62716-665 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19840101 UNAPPROVED MEDICAL GAS Hutchinson Healthcare Services, Inc. dba Health-E-Quip OXYGEN 99 L/100L 62721-0118_3e4c121a-b3ba-468a-a6c5-29801201c44a 62721-0118 HUMAN OTC DRUG Lornamead Yardley Triclosan SOAP TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part333E Lornamead TRICLOSAN .2 g/100mL 62721-0214_24b2afa2-d351-489f-96b8-fa63009523d4 62721-0214 HUMAN OTC DRUG Big Lots Sound Body Fluoride PASTE, DENTIFRICE DENTAL 20140305 OTC MONOGRAPH NOT FINAL part356 Lornamead POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 62721-0470_e961d00c-5ba3-4b53-8f05-1077d95b4beb 62721-0470 HUMAN OTC DRUG Lornamead Natural White Fluoride PASTE, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 Lornamead POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 62721-0471_5c9bad48-c405-4eb4-bacf-6f6a32ad1a37 62721-0471 HUMAN OTC DRUG Lornamead Natural White Fluoride PASTE, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 Lornamead POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 62721-0472_05947ed0-2f4a-4a5d-89d9-b68fa3c04031 62721-0472 HUMAN OTC DRUG Lornamead Natural White Fluoride PASTE, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 Lornamead SODIUM FLUORIDE .24 g/100g 62721-0473_edfc63e8-ae49-4f62-850c-1ea5f3a5e9cb 62721-0473 HUMAN OTC DRUG Natural White Radiant White Fluoride PASTE, DENTIFRICE DENTAL 20130101 OTC MONOGRAPH NOT FINAL part356 Lornamead SODIUM FLUORIDE .243 g/100g 62721-8106_6efe4f44-9720-44d5-b47b-49e0992d8e29 62721-8106 HUMAN OTC DRUG LypSyl Honeyberry OCTINOXATE LIPSTICK TOPICAL 20091001 OTC MONOGRAPH FINAL part352 Lornamead OCTINOXATE; OCTOCRYLENE; OXYBENZONE 5.5; 2; 3.5 g/100g; g/100g; g/100g 62721-8110_9644b4b3-6cf7-491c-afaa-603b74f22330 62721-8110 HUMAN OTC DRUG Lornamead Yardley Triclosan SOAP TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part333E Lornamead TRICLOSAN .2 g/100mL 62721-8114_486da846-a7dc-4b1c-a271-07e75aaa440b 62721-8114 HUMAN OTC DRUG Lornamead Lypsyl PETROLATUM PASTE TOPICAL 20120201 OTC MONOGRAPH FINAL part346 Lornamead MENTHOL; PETROLATUM .3; 65.004 g/100g; g/100g 62721-8116_c7945e29-2a20-4731-a614-97ce1bdd9c1f 62721-8116 HUMAN OTC DRUG LypSyl Honeyberry Lip Balm LIPSTICK TOPICAL 20121031 OTC MONOGRAPH FINAL part352 Lornamead AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 2; 5.5; 2; 3.5 g/100g; g/100g; g/100g; g/100g 62721-8117_d48300f2-8599-47e9-8a1c-1e7c3dd826e7 62721-8117 HUMAN OTC DRUG LypSyl Vanilla Plum Intense Protection Lip Balm LIPSTICK TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Lornamead AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 2; 5.5; 2; 3.5 g/100g; g/100g; g/100g; g/100g 62721-8127_2771ef5a-bde4-46b0-8a8c-d4c5d0b807ed 62721-8127 HUMAN OTC DRUG LypSyl Vanilla Plum Intense Protection Lip Balm LIPSTICK TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Lornamead AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3; 5.5; 2; 3.5 g/100g; g/100g; g/100g; g/100g 62737-123_477f641f-a3fc-4b98-813b-c1779937b2d4 62737-123 HUMAN PRESCRIPTION DRUG Oxygen oxygen GAS RESPIRATORY (INHALATION) 19960419 UNAPPROVED MEDICAL GAS Air Care Home Health Inc OXYGEN 1 L/L 62741-0123_342e85ec-7690-4a92-af22-e6bc12a536f9 62741-0123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19960605 UNAPPROVED MEDICAL GAS B&K Prescription Shop OXYGEN 99 L/100L 62742-4028_6c2cd9ac-b90c-4ef3-8b59-7c4c231f51bd 62742-4028 HUMAN OTC DRUG SARAH CHAPMAN London SKINESIS Dynamic Defence Concentrate Anti-Ageing Day Cream SPF 15 OCTYL METHOXYCINNAMATE , OCTYL SALICYLATE, OXYBENZONE, AND AVOBENZONE CREAM TOPICAL 20100504 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL 62742-4029_d112300c-a0c7-4ae0-9a3d-835d817db48c 62742-4029 HUMAN OTC DRUG SARAH CHAPMAN London SKINESIS Dynamic Defence Anti-Ageing Day SPF 15 OCTYL METHOXYCINNAMATE , OCTYL SALICYLATE, OXYBENZONE, AND AVOBENZONE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL 62742-4030_04dd129a-7c7b-42a0-8803-dbdda59396de 62742-4030 HUMAN OTC DRUG DermaQuest TM Skin Therapy, Breathable Coverage TM Mineral Foundation SPF-30, DermaMinerals TM Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part352 Allure Labs, Inc. TITANIUM DIOXIDE; ZINC OXIDE 48; 58 mg/mL; mg/mL 62742-4031_b552f601-7915-4822-8202-136919ba22fb 62742-4031 HUMAN OTC DRUG Lycogel Cover and Recovery - Breathable Camouflage - SPF 30 with LYCO Complex Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20100201 UNAPPROVED DRUG OTHER Allure Cosmetic, Inc. TITANIUM DIOXIDE; ZINC OXIDE 65; 82 mg/mL; mg/mL 62742-4032_6cd649e2-95e4-4138-b16d-9e95e2f328b8 62742-4032 HUMAN OTC DRUG Lycogel Cover and Recovery - Breathable Concealer - SPF 30 with LYCO Complex Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20100201 UNAPPROVED DRUG OTHER Allure Cosmetic, Inc. TITANIUM DIOXIDE; ZINC OXIDE 65; 82 mg/mL; mg/mL 62742-4033_d9119131-1bda-4895-9d5a-98500f94cc80 62742-4033 HUMAN OTC DRUG AGELESS Total Skin Bleaching Serum HYDROQUINONE LIQUID TOPICAL 20100101 OTC MONOGRAPH FINAL part358 Allure Labs, Inc. HYDROQUINONE 20 mg/mL 62742-4034_fc86ed15-9e81-4407-9c43-2c79a1e6d057 62742-4034 HUMAN OTC DRUG CLEAR CELL Medicated Acne Scrub Benzoyl Peroxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Allure Labs, Inc. BENZOYL PEROXIDE 30 mg/mL 62742-4035_850ae55b-b7fb-47fb-bc41-0e93766c5038 62742-4035 HUMAN OTC DRUG CLEAR CELL Medicated Acne Benzoyl Peroxide, Salicylic Acid LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Allure Labs, Inc. BENZOYL PEROXIDE; SALICYLIC ACID 50; 30 mg/mL; mg/mL 62742-4036_2c2af16e-4a6c-436b-bcef-ff531e8f908f 62742-4036 HUMAN OTC DRUG AGELESS Total Rejuvenating Hand Octinoxate, Octisalate, Avobenzone, Octocrylene CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 20; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL 62742-4037_cea5b90c-cb67-4803-910e-625cba66ff37 62742-4037 HUMAN OTC DRUG SUN Solar Defense Hydrating Zinc Oxide, Ethylhexyl Methoxycinnamate, Benzophenone, Ethylhexyl Salicylate CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 75; 50; 30; 50 mg/mL; mg/mL; mg/mL; mg/mL 62742-4038_4eca3569-57ff-4766-833a-e74496eb2969 62742-4038 HUMAN OTC DRUG SUN Solar Defense Organic SPF30 Zinc Oxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE 190 mg/mL 62742-4039_1f4eca23-2fe7-4ba0-8e19-7923e510efa8 62742-4039 HUMAN OTC DRUG SUN Solar Defense Oil-free Gel SPF 15 Titanium Dioxide, Ethylhexyl Methoxycinnamate, Benzophenone-3 CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 75; 30; 16 mg/mL; mg/mL; mg/mL 62742-4040_e091db7c-bb5c-4180-a20b-67f7bd20125f 62742-4040 HUMAN OTC DRUG SUN Solar Defense Oil-free SPF 30 Zinc Oxide GEL TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE 186 mg/mL 62742-4041_9bdd2920-7c83-4fa7-83d9-c85a69e7e9e0 62742-4041 HUMAN OTC DRUG SUN Tinted Solar Defense Organic SPF 30 Zinc Oxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE 170 mg/mL 62742-4042_c7853422-d511-4d01-b8fb-577cab24e80b 62742-4042 HUMAN OTC DRUG Clear Cell Salicylic Clarifying Pads Salicylic Acid LIQUID TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Allure Labs, Inc. SALICYLIC ACID 50 mg/mL 62742-4043_86dde41e-2909-4f02-a32c-01b8eac550fe 62742-4043 HUMAN OTC DRUG Clear Cell Salicylic Clarifying Tonic Salicylic Acid and Glycolic Acid LIQUID TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Allure Labs, Inc. GLYCOLIC ACID; SALICYLIC ACID 50; 30 mg/mL; mg/mL 62742-4044_fc49cd9b-0e3f-4a43-acd9-1fcd12912f78 62742-4044 HUMAN OTC DRUG Clear Cell Medicated Acne Masque Salicylic Acid CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Allure Labs, Inc. SALICYLIC ACID 50 mg/mL 62742-4045_8362fe8b-006d-46bd-a031-d4945a4ca543 62742-4045 HUMAN OTC DRUG Clear Cell Cleanser Salicylic Acid GEL TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Allure Labs, Inc. SALICYLIC ACID 30 mg/mL 62742-4046_e379ec77-67e5-4867-9f91-b2add725aa16 62742-4046 HUMAN OTC DRUG Image MD Lightening Rx Hydroquinone CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part358 Allure Labs, Inc. HYDROQUINONE 40 mg/mL 62742-4047_e657a245-4cb4-4b20-a54c-358bd8020cd9 62742-4047 HUMAN OTC DRUG No Foundation SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. TITANIUM DIOXIDE; ZINC OXIDE 32; 122 mg/mL; mg/mL 62742-4048_fbdbe9ea-323a-4651-b480-28864dc02675 62742-4048 HUMAN OTC DRUG No Foundation SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. TITANIUM DIOXIDE; ZINC OXIDE 32; 122 mg/mL; mg/mL 62742-4049_d602176d-bde5-462c-bb52-714baf35a214 62742-4049 HUMAN OTC DRUG More Than Moisture SPF 30 Zinc Oxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE 105 mg/mL 62742-4050_2277495d-ecbd-44de-84cd-c822b80275cd 62742-4050 HUMAN OTC DRUG Acne TX Mask Benzoyl Peroxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Allure Labs, Inc. BENZOYL PEROXIDE 25 mg/mL 62742-4051_9ff762a4-f617-49f4-b8fa-07a39880c4ff 62742-4051 HUMAN OTC DRUG Dermaquest Skin Therapy Post-Skin Resurfacing Balm Hydrocortisone CREAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part348 Allure Labs, Inc. HYDROCORTISONE 10 mg/mL 62742-4052_c54081b5-aa9f-4b30-a94a-7a29082d490f 62742-4052 HUMAN OTC DRUG Dermaquest Skin Therapy Solar Protection SPF 15 Zinc Oxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE 95 mg/mL 62742-4053_ac4da00a-cc70-4ef2-a4b1-c3a6a704c8d4 62742-4053 HUMAN OTC DRUG Dermaquest Skin Therapy Daily Moisturizing SPF 15 Zinc Oxide LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE 95 mg/mL 62742-4054_b488e143-c279-4cd5-b551-461a729bcda6 62742-4054 HUMAN OTC DRUG Kid Safe Screen Zinc Oxide CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 Allure Labs, Inc. ZINC OXIDE 200 mg/mL 62742-4055_5ccb438c-b09b-4e92-a28a-c2fb1b28d462 62742-4055 HUMAN OTC DRUG Moisturizing Face Screen Medium Tint SPF 30 Zinc Oxide CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 Allure Labs, Inc. ZINC OXIDE 200 mg/mL 62742-4056_67912097-334d-4f03-80a8-393bd34fefa8 62742-4056 HUMAN OTC DRUG Moisturizing Face Screen SPF 30 Zinc Oxide CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 Allure Labs, Inc. ZINC OXIDE 200 mg/mL 62742-4057_f603a589-bea4-4407-9607-f969830d2af7 62742-4057 HUMAN OTC DRUG Moisturizing Face Screen Light Tint SPF 30 Zinc Oxide CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 Allure Labs, Inc. ZINC OXIDE 200 mg/mL 62742-4058_a268c744-6523-47b0-9f3c-d53ebdf7b904 62742-4058 HUMAN OTC DRUG Anti-Bacterial Wash with Exfoliating Beads for Blemish skin Benzoyl Peroxide GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333D Allure Labs, Inc. BENZOYL PEROXIDE 25 mg/mL 62742-4059_ec8a7b23-aa83-406f-854b-a3474a716798 62742-4059 HUMAN OTC DRUG No Concealer Concealer Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20131209 OTC MONOGRAPH FINAL part352 Allure Labs, Inc TITANIUM DIOXIDE; ZINC OXIDE 48; 58.8 mg/g; mg/g 62742-4060_908dfa20-4f1d-4c34-b85e-f5ec09b7eda7 62742-4060 HUMAN OTC DRUG No Foundation Foundation Fair Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Allure Labs, Inc TITANIUM DIOXIDE; ZINC OXIDE 32; 122 mg/mL; mg/mL 62742-4061_2e3befa1-ca89-42df-9933-d2403b24a6e3 62742-4061 HUMAN OTC DRUG No Foundation SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20131231 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. TITANIUM DIOXIDE; ZINC OXIDE 32; 122 mg/mL; mg/mL 62742-4062_7ff3a174-91b1-4411-bdc2-95b4a2369eac 62742-4062 HUMAN OTC DRUG No Concealer Concealer No.2 Light to Medium Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140326 OTC MONOGRAPH FINAL part352 Allure Labs, Inc TITANIUM DIOXIDE; ZINC OXIDE 48; 58.8 mg/g; mg/g 62742-4063_be855b3f-4c30-48f4-9fbb-514209d00242 62742-4063 HUMAN OTC DRUG No Foundation Foundation No.1 Fair to Light Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20140418 OTC MONOGRAPH FINAL part352 Allure Labs, Inc TITANIUM DIOXIDE; ZINC OXIDE 32; 122 mg/mL; mg/mL 62742-4064_2aeda5d4-0cd2-4cd8-a12d-880ded11d9d2 62742-4064 HUMAN OTC DRUG ZinClear SPF 30 Tinted Zinc Oxide CREAM TOPICAL 20140422 OTC MONOGRAPH FINAL part352 Allure Labs Inc. ZINC OXIDE 186 mg/g 62742-4066_2032c3e0-9ada-4654-a245-53577d1243ef 62742-4066 HUMAN OTC DRUG No Foundation Foundation No.2 Light to Medium Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. TITANIUM DIOXIDE; ZINC OXIDE 32; 122 mg/mL; mg/mL 62742-4067_e200363c-eb83-4b5d-be27-390b206852f9 62742-4067 HUMAN OTC DRUG Prevention daily tinted mositurizer oil-free Tinted 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20140509 OTC MONOGRAPH FINAL part352 Allure Labs, Inc TITANIUM DIOXIDE; ZINC OXIDE 46; 60 mg/g; mg/g 62742-4068_c212882f-4802-4f7c-b4f4-3b71ec62ac04 62742-4068 HUMAN OTC DRUG Youth Protection SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20140528 OTC MONOGRAPH FINAL part352 Allure Labs, Inc TITANIUM DIOXIDE; ZINC OXIDE 20; 186 mg/g; mg/g 62742-4070_616b9d44-1e75-4257-9beb-62bed2946b9f 62742-4070 HUMAN OTC DRUG Clarifying Toner Salicylic Acid LIQUID TOPICAL 20140607 OTC MONOGRAPH FINAL part333D Allure Labs, Inc SALICYLIC ACID 10 mg/mL 62742-4071_bcc0b356-4c14-46e9-8ad9-aa2db6f6bdf0 62742-4071 HUMAN OTC DRUG Foaming Cleanser Salicylic Acid LIQUID TOPICAL 20140607 OTC MONOGRAPH FINAL part333D Allure Labs, Inc SALICYLIC ACID 20 mg/mL 62742-4072_8e09e1c4-7b7b-4a2f-89d5-f0251b9da39a 62742-4072 HUMAN OTC DRUG Acne LotionSulfur Sulfur Sulfur LOTION TOPICAL 20140610 OTC MONOGRAPH FINAL part333D Allure Labs, Inc SULFUR 30 mg/mL 62750-001_6f5ee45c-b8e7-48b2-8aea-2a81890016db 62750-001 HUMAN OTC DRUG Zicam Allergy Relief galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, and sulfur SPRAY NASAL 20100701 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; SULFUR 30; 200; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62750-001_933f97f7-86f0-4397-bd68-dd69550a6054 62750-001 HUMAN OTC DRUG Zicam Allergy Relief galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, and sulfur SPRAY NASAL 20000414 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; SULFUR 30; 200; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62750-003_5ea4dd62-7f3e-49de-beab-907f456cee0f 62750-003 HUMAN OTC DRUG Zicam zinc gluconate SWAB NASAL 20020802 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC GLUCONATE 2 [hp_X]/1 62750-003_931e100a-bc8d-4ef8-9b13-6a8cafa84389 62750-003 HUMAN OTC DRUG Zicam zinc gluconate SWAB NASAL 20080122 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC GLUCONATE 2 [hp_X]/1 62750-003_a7823776-d480-4036-8858-bc6ae5098e7b 62750-003 HUMAN OTC DRUG Zicam zinc gluconate SWAB NASAL 20080923 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC GLUCONATE 2 [hp_X]/1 62750-004_9ccc0e1a-5b4d-43ba-8fa8-071a285dcc7b 62750-004 HUMAN OTC DRUG Zicam Allergy Relief galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, and sulfur SWAB NASAL 20000414 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; SULFUR 30; 200; 30; 200 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 62750-005_37381029-512b-45b6-a5a9-53e466406912 62750-005 HUMAN OTC DRUG Zicam oxymetazoline Hydrochloride SPRAY NASAL 20100701 OTC MONOGRAPH FINAL part341 Matrixx Initiatives, Inc. OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL 62750-005_a4520676-b0dc-4674-8e71-187d0163d043 62750-005 HUMAN OTC DRUG Zicam oxymetazoline hydrochloride SPRAY NASAL 20020520 OTC MONOGRAPH FINAL part341 Matrixx Initiatives, Inc. OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL 62750-006_432968ce-1b59-4149-b88b-0657cf84fa1d 62750-006 HUMAN OTC DRUG Zicam oxymetazoline hydrochloride SPRAY NASAL 20020529 OTC MONOGRAPH FINAL part341 Matrixx Initiatives, Inc. OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL 62750-006_d98c2b3d-a28d-4a86-a743-1433d9c6dcb3 62750-006 HUMAN OTC DRUG Zicam oxymetazoline Hydrochloride SPRAY NASAL 20100701 OTC MONOGRAPH FINAL part341 Matrixx Initiatives, Inc. OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL 62750-008_b04b0c2f-d9f5-4818-8ce3-0e6ecdc29ac3 62750-008 HUMAN OTC DRUG Zicam zinc acetate and zinc gluconate TABLET, ORALLY DISINTEGRATING ORAL 20070907 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 62750-008_fbf68d98-cd2d-434f-b9e4-1b6f9ecd214b 62750-008 HUMAN OTC DRUG Zicam zinc acetate and zinc gluconate TABLET, ORALLY DISINTEGRATING ORAL 20050727 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 62750-016_5462b69c-ffa4-4bed-a0c7-2a7af95bb397 62750-016 HUMAN OTC DRUG Zicam Cough MAX dextromethorphan hydrobromide SPRAY ORAL 20050803 OTC MONOGRAPH FINAL part341 Matrixx Initiatives, Inc. DEXTROMETHORPHAN HYDROBROMIDE 6 mg/.25mL 62750-022_894c3711-9bcb-4f77-a43e-307a675d7a5f 62750-022 HUMAN OTC DRUG Zicam acetaminophen, dextromethorphan hydrobromide and guaifenesin LIQUID ORAL 20070716 OTC MONOGRAPH FINAL part341 Matrixx Initiatives, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 325; 10; 200 mg/15mL; mg/15mL; mg/15mL 62750-023_593326eb-d459-43cb-9dbb-fdfa57f2acea 62750-023 HUMAN OTC DRUG Zicam acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20070716 OTC MONOGRAPH FINAL part341 Matrixx Initiatives, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 10; 6.25 mg/15mL; mg/15mL; mg/15mL 62750-025_21743d92-9ba1-4bfe-bbf0-6e5cd2f0a350 62750-025 HUMAN OTC DRUG Zicam Cold Remedy zinc acetate and zinc gluconate BAR, CHEWABLE ORAL 20030822 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 2 [hp_X]/1; [hp_X]/1 62750-026_88328e3d-98f1-4884-ae85-36ddc2123fbf 62750-026 HUMAN OTC DRUG Zicam zinc acetate and zinc gluconate SWAB NASAL 20080923 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 2 [hp_X]/1; [hp_X]/1 62750-027_aa67c595-8f4e-40ca-bc90-a25a857c456a 62750-027 HUMAN OTC DRUG Zicam Naturals Cough Suppressant mentha piperita LIQUID ORAL 20110101 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. MENTHA PIPERITA 3 [hp_X]/188mL 62750-029_1621325f-61d5-4b93-8ce8-4ddc2dd65bb2 62750-029 HUMAN OTC DRUG Zicam Cold Remedy Zavors zinc acetate and zinc gluconate TABLET, CHEWABLE ORAL 20090519 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 2 [hp_X]/1; [hp_X]/1 62750-031_f9f43162-3281-4e16-ac43-e63663fc388b 62750-031 HUMAN OTC DRUG Zicam zinc acetate and zinc gluconate SPRAY ORAL 20030812 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/mL; [hp_X]/mL 62750-032_3b5111f7-837f-49a3-a8c9-5de57ca413c7 62750-032 HUMAN OTC DRUG Zicam zinc acetate and zinc gluconate SPRAY ORAL 20100701 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/mL; [hp_X]/mL 62750-033_115a323d-f166-4584-9946-2327afcecaec 62750-033 HUMAN OTC DRUG Zicam zinc acetate and zinc gluconate TABLET, ORALLY DISINTEGRATING ORAL 20030804 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 62750-034_43ad660d-3d7b-47d8-85a7-5838371f7c4d 62750-034 HUMAN OTC DRUG Zicam zinc acetate and zinc gluconate TABLET, ORALLY DISINTEGRATING ORAL 20060721 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 62750-035_eb4c1431-0bd3-41de-995f-a56ae32438ef 62750-035 HUMAN OTC DRUG Zicam zinc acetate and zinc gluconate TABLET, ORALLY DISINTEGRATING ORAL 20081107 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 62750-036_d2c28148-5bf6-43d0-8525-1db76815dd90 62750-036 HUMAN OTC DRUG Zicam Naturals Cough Suppressant mentha piperita LIQUID ORAL 20110101 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. MENTHA PIPERITA 3 [hp_X]/120mL 62750-037_4e1f5875-b981-49f5-8dd5-c6218919118d 62750-037 HUMAN OTC DRUG Zicam Cold Remedy Kids Soft Chews ZINC ACETATE ANHYDROUS and ZINC GLUCONATE BAR, CHEWABLE ORAL 20140801 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 2 [hp_X]/1; [hp_X]/1 62750-039_7c0d1ca9-518b-4ad8-9ede-59a0f8addf4c 62750-039 HUMAN OTC DRUG Zicam Cold Remedy Ultra Rapidmelts ZINC ACETATE ANHYDROUS and ZINC GLUCONATE TABLET, MULTILAYER ORAL 20110701 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 62750-040_3213868a-647b-401c-a4fe-a5c59c76ce94 62750-040 HUMAN OTC DRUG Zicam Cold Remedy Ultra Rapidmelts ZINC ACETATE ANHYDROUS and ZINC GLUCONATE TABLET, MULTILAYER ORAL 20110701 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 62750-041_94e58c1a-fec6-4317-8385-2e843e5107d0 62750-041 HUMAN OTC DRUG Duract Max Strength Cough Dextromethorphan Hydrobromide TABLET, ORALLY DISINTEGRATING ORAL 20110801 OTC MONOGRAPH FINAL part341 Matrixx Initiatives, Inc. DEXTROMETHORPHAN HYDROBROMIDE 30 mg/1 62750-042_2ef06f65-fc5c-4ffc-b1ef-fa877d951718 62750-042 HUMAN OTC DRUG Duract Max Strength Cough Dextromethorphan Hydrobromide TABLET, ORALLY DISINTEGRATING ORAL 20110801 OTC MONOGRAPH FINAL part341 Matrixx Initiatives, Inc. DEXTROMETHORPHAN HYDROBROMIDE 30 mg/1 62750-043_535eff97-8212-488e-86b4-e56f9c461e8f 62750-043 HUMAN OTC DRUG Zicam Cold Remedy Rapidmelts with Echinacea ZINC ACETATE ANHYDROUS, ECHINACEA ANGUSTIFOLIA, and ZINC GLUCONATE TABLET ORAL 20111001 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ECHINACEA ANGUSTIFOLIA; ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 5; 2; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 62750-044_01d1dee8-0597-4621-a31f-e02f9985282e 62750-044 HUMAN OTC DRUG Zicam Cold Remedy Rapidmelts Citrus ZINC ACETATE ANHYDROUS and ZINC GLUCONATE TABLET ORAL 20111001 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 62750-045_647bd5d9-6708-4bc7-8c75-08e76bb8e005 62750-045 HUMAN OTC DRUG Zicam Cold Remedy Plus Mist ZINC ACETATE ANHYDROUS and ZINC GLUCONATE SPRAY ORAL 20120801 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 1 [hp_X]/mL; [hp_X]/mL 62750-046_97f7db30-2315-4d50-844c-3e64731b4860 62750-046 HUMAN OTC DRUG Zicam Ultra Cold Remedy ZINC ACETATE ANHYDROUS and ZINC GLUCONATE CRYSTAL ORAL 20120701 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 1 [hp_X]/g; [hp_X]/g 62750-048_89921c34-4d9d-4c03-87e6-db4263876dc1 62750-048 HUMAN OTC DRUG Zicam Naturals Cough Suppressant Mentha Piperita SYRUP ORAL 20120801 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. MENTHA PIPERITA 4 [hp_X]/mL 62750-049_d0c718b2-2476-428b-b904-beadeb61d9e2 62750-049 HUMAN OTC DRUG Zicam Ultra Cold Remedy ZINC ACETATE ANHYDROUS and ZINC GLUCONATE LOZENGE ORAL 20120801 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 2 [hp_X]/1; [hp_X]/1 62750-050_47d5f216-89a5-4dde-989e-059cbe4aa4b4 62750-050 HUMAN OTC DRUG Zicam Naturals Cough Suppressant Mentha Piperita SYRUP ORAL 20120801 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. MENTHA PIPERITA 4 [hp_X]/mL 62750-051_91ae180a-fdbe-4774-8cbb-335dc59662fc 62750-051 HUMAN OTC DRUG Zicam Ultra Cold Remedy Rapidmelts ZINC ACETATE ANHYDROUS and ZINC GLUCONATE TABLET ORAL 20120901 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 62750-052_51105822-9252-4546-a3aa-b9001f22c5d2 62750-052 HUMAN OTC DRUG Zicam Ultra Cold Remedy Rapidmelts ZINC ACETATE ANHYDROUS and ZINC GLUCONATE TABLET ORAL 20120901 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 62750-054_7c10dfd6-b6e7-445d-a477-389b432275f7 62750-054 HUMAN OTC DRUG Zicam Cold Remedy Rapidmelts ZINC ACETATE ANHYDROUS and ZINC GLUCONATE TABLET ORAL 20120801 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 62750-055_46690873-9d72-4e10-a4e2-dd019c5291e5 62750-055 HUMAN OTC DRUG Zicam Cold Remedy Ultra Rapidmelts zinc acetate and zinc gluconate TABLET ORAL 20130214 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 62750-056_69ae1dcd-a74c-4aca-acfc-87f30cced66b 62750-056 HUMAN OTC DRUG Zicam Cold Remedy Ultra Rapidmelts zinc acetate and zinc gluconate TABLET ORAL 20130214 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 62750-057_b48db9b7-c986-4b37-a857-a68752f8e3be 62750-057 HUMAN OTC DRUG Zicam Cold Remedy Rapidmelts Zinc gluconate TABLET ORAL 20130201 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC GLUCONATE 1 [hp_X]/1 62750-058_bd3bbc49-5544-405d-aee3-fcb31a38935e 62750-058 HUMAN OTC DRUG Zicam Cold Remedy Liqui-Loz zinc acetate and zinc gluconate LOZENGE ORAL 20130201 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 2 [hp_X]/1; [hp_X]/1 62750-059_5f3c5d1c-946f-469e-abf3-1f786c9955ed 62750-059 HUMAN OTC DRUG Zicam Cold Remedy Oral Mist ZINC ACETATE and ZINC GLUCONATE SPRAY ORAL 20130301 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/mL; [hp_X]/mL 62750-060_865dfe2a-4963-45ed-b6b5-0f8aaa0d10f0 62750-060 HUMAN OTC DRUG Zicam Cold Remedy Oral Mist ZINC ACETATE and ZINC GLUCONATE SPRAY ORAL 20130301 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/mL; [hp_X]/mL 62750-065_b96f9858-2201-47da-84ff-6993573ac00a 62750-065 HUMAN OTC DRUG Zicam Cold Remedy ZINC ACETATE ANHYDROUS, ZINC GLUCONATE, and MENTHOL LOZENGE ORAL 20140801 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. MENTHOL; ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 4; 2; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1 62750-070_22a75417-84be-439c-964a-6f148a084909 62750-070 HUMAN OTC DRUG Zicam Cold Remedy GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT, and SCHOENOCAULON OFFICINALE SEED SPRAY NASAL 20140801 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. GALPHIMIA GLAUCA FLOWERING TOP; LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED 4; 4; 4 [hp_X]/.56mL; [hp_X]/.56mL; [hp_X]/.56mL 62756-015_e12d8ae5-9555-4283-813a-4bde19fba036 62756-015 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20130617 ANDA ANDA201720 Sun Pharmaceutical Industries Limited TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 62756-016_e12d8ae5-9555-4283-813a-4bde19fba036 62756-016 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20130617 ANDA ANDA201720 Sun Pharmaceutical Industries Limited TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 62756-017_e12d8ae5-9555-4283-813a-4bde19fba036 62756-017 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20130617 ANDA ANDA201720 Sun Pharmaceutical Industries Limited TESTOSTERONE CYPIONATE 100 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 62756-023_854fb002-7f1d-4575-85bd-907cefc04606 62756-023 HUMAN PRESCRIPTION DRUG Topotecan hydrochloride Topotecan hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130831 ANDA ANDA202203 Sun Pharmaceutical Industries Limited TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 62756-093_23f08ea3-8b3d-4019-a781-463b4cb1b7b5 62756-093 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20120831 ANDA ANDA077372 SUN PHARMACEUTICAL INDUSTRIES LIMITED OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 62756-094_23f08ea3-8b3d-4019-a781-463b4cb1b7b5 62756-094 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20120831 ANDA ANDA077372 SUN PHARMACEUTICAL INDUSTRIES LIMITED OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 62756-095_23f08ea3-8b3d-4019-a781-463b4cb1b7b5 62756-095 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20120831 ANDA ANDA077372 SUN PHARMACEUTICAL INDUSTRIES LIMITED OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 62756-130_00ddd886-534b-4fe8-b9e6-a7c799884ed1 62756-130 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Sun Pharmaceutical Industries Limited ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 62756-131_00ddd886-534b-4fe8-b9e6-a7c799884ed1 62756-131 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Sun Pharmaceutical Industries Limited ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 62756-137_b40a08dc-f97d-43b8-a40d-119adbd7dff1 62756-137 HUMAN PRESCRIPTION DRUG gabapentin gabapentin CAPSULE ORAL 20060824 ANDA ANDA077242 Sun Pharmaceutical Industries Limited GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-138_b40a08dc-f97d-43b8-a40d-119adbd7dff1 62756-138 HUMAN PRESCRIPTION DRUG gabapentin gabapentin CAPSULE ORAL 20060824 ANDA ANDA077242 Sun Pharmaceutical Industries Limited GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-139_b40a08dc-f97d-43b8-a40d-119adbd7dff1 62756-139 HUMAN PRESCRIPTION DRUG gabapentin gabapentin CAPSULE ORAL 20060824 ANDA ANDA077242 Sun Pharmaceutical Industries Limited GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-142_9a5f7645-ecab-4adc-9f4b-94140a9aa06b 62756-142 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 Sun Pharmaceutical Industries Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 62756-143_9a5f7645-ecab-4adc-9f4b-94140a9aa06b 62756-143 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 Sun Pharmaceutical Industries Limited METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 62756-144_c9f16065-a9d4-4566-b51a-d4d125f4f913 62756-144 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20141215 ANDA ANDA077058 Sun Pharmaceutical Industries Limited PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 62756-145_e10fad35-d2b1-4c4d-9621-a0d4eec6a877 62756-145 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077131 Sun Pharmaceutical Industries Limited RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 62756-146_e10fad35-d2b1-4c4d-9621-a0d4eec6a877 62756-146 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077131 Sun Pharmaceutical Industries Limited RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 62756-147_e10fad35-d2b1-4c4d-9621-a0d4eec6a877 62756-147 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077131 Sun Pharmaceutical Industries Limited RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 62756-148_e10fad35-d2b1-4c4d-9621-a0d4eec6a877 62756-148 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077131 Sun Pharmaceutical Industries Limited RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 62756-160_4610cb8c-cc5b-48f0-b16c-f34fe1ece4e2 62756-160 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100715 ANDA ANDA090931 Sun Pharmaceutical Industries Limited TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 62756-161_7f3fe422-471d-4136-82ef-8a5c1c9451ef 62756-161 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate SOLUTION NASAL 20120414 ANDA ANDA077212 Sun Pharmaceutical Industries Limited DESMOPRESSIN ACETATE .1 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 62756-181_4509aa41-75c6-49da-8fb0-717483e5c8dc 62756-181 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077173 Sun Pharmaceutical Industries Limited ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 62756-182_4509aa41-75c6-49da-8fb0-717483e5c8dc 62756-182 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077172 Sun Pharmaceutical Industries Limited ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 62756-183_cbef0d6f-34a3-4506-80d8-e71a11a2838f 62756-183 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 Sun Pharmaceutical Industries Limited OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-184_cbef0d6f-34a3-4506-80d8-e71a11a2838f 62756-184 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 Sun Pharmaceutical Industries Limited OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-185_cbef0d6f-34a3-4506-80d8-e71a11a2838f 62756-185 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 Sun Pharmaceutical Industries Limited OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-186_9d9c6786-fa0c-49c8-9e07-889d50d67f2a 62756-186 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, ORALLY DISINTEGRATING ORAL 20090814 ANDA ANDA078690 Sun Pharmaceutical Industries Limited CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 62756-187_9d9c6786-fa0c-49c8-9e07-889d50d67f2a 62756-187 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, ORALLY DISINTEGRATING ORAL 20090814 ANDA ANDA078690 Sun Pharmaceutical Industries Limited CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 62756-188_9d9c6786-fa0c-49c8-9e07-889d50d67f2a 62756-188 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, ORALLY DISINTEGRATING ORAL 20090814 ANDA ANDA078690 Sun Pharmaceutical Industries Limited CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 62756-200_10353c8c-0bbe-4817-b2cc-2c52644ef956 62756-200 HUMAN PRESCRIPTION DRUG TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20111104 ANDA ANDA077555 Sun Pharmaceutical Industries Limited TIAGABINE HYDROCHLORIDE 2 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-202_8146c300-ea5d-496e-9031-f3b89176c36d 62756-202 HUMAN PRESCRIPTION DRUG gabapentin gabapentin TABLET, FILM COATED ORAL 20060824 ANDA ANDA077525 Sun Pharmaceutical Industries Limited GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-204_8146c300-ea5d-496e-9031-f3b89176c36d 62756-204 HUMAN PRESCRIPTION DRUG gabapentin gabapentin TABLET, FILM COATED ORAL 20060824 ANDA ANDA077525 Sun Pharmaceutical Industries Limited GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-218_e69b7675-0377-4736-9bb9-166f651c815c 62756-218 HUMAN PRESCRIPTION DRUG IBANDRONATE SODIUM IBANDRONATE SODIUM INJECTION, SOLUTION INTRAVENOUS 20140215 ANDA ANDA090853 Sun Pharmaceutical Industries Limited IBANDRONATE SODIUM 3 mg/3mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 62756-224_10353c8c-0bbe-4817-b2cc-2c52644ef956 62756-224 HUMAN PRESCRIPTION DRUG TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20111104 ANDA ANDA077555 Sun Pharmaceutical Industries Limited TIAGABINE HYDROCHLORIDE 4 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-240_fd604c91-f150-48b4-971f-ae14184e8a4d 62756-240 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Sun Pharmaceutical Industries Limited ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 62756-250_4a3e38c8-4ff9-440a-90de-3f3eb29db2b5 62756-250 HUMAN PRESCRIPTION DRUG ANASTROZOLE ANASTROZOLE TABLET, FILM COATED ORAL 20100716 ANDA ANDA091177 Sun Pharmaceutical Industries Limited ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 62756-258_7756372c-ed83-46a9-b761-8e0fc98781fd 62756-258 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060317 ANDA ANDA077634 Sun Pharmaceutical Industries Limited ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-259_7756372c-ed83-46a9-b761-8e0fc98781fd 62756-259 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060317 ANDA ANDA077634 Sun Pharmaceutical Industries Limited ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-260_7756372c-ed83-46a9-b761-8e0fc98781fd 62756-260 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060317 ANDA ANDA077634 Sun Pharmaceutical Industries Limited ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-293_ec678657-42f1-4a51-a596-129033e2ff60 62756-293 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Sun Pharmaceutical Industries Limited CEPHALEXIN 250 mg/1 62756-294_ec678657-42f1-4a51-a596-129033e2ff60 62756-294 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Sun Pharmaceutical Industries Limited CEPHALEXIN 500 mg/1 62756-299_5c0df328-9b69-4898-8234-58dc1669d779 62756-299 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20080630 ANDA ANDA040731 SUN PHARMACEUTICAL INDUSTRIES LIMITED PHENYTOIN SODIUM 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-310_461bf92c-0ad0-4e99-8542-6dc6bfbde5f1 62756-310 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET, FILM COATED ORAL 20090618 ANDA ANDA090800 Sun Pharmaceutical Industries Limited QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 62756-311_461bf92c-0ad0-4e99-8542-6dc6bfbde5f1 62756-311 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET, FILM COATED ORAL 20090618 ANDA ANDA090800 Sun Pharmaceutical Industries Limited QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 62756-312_461bf92c-0ad0-4e99-8542-6dc6bfbde5f1 62756-312 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET, FILM COATED ORAL 20090618 ANDA ANDA090800 Sun Pharmaceutical Industries Limited QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 62756-313_461bf92c-0ad0-4e99-8542-6dc6bfbde5f1 62756-313 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET, FILM COATED ORAL 20090618 ANDA ANDA090800 Sun Pharmaceutical Industries Limited QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 62756-329_cafe4650-6aa4-4466-9beb-064ee5a0e401 62756-329 HUMAN PRESCRIPTION DRUG EPINASTINE HYDROCHLORIDE EPINASTINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20111101 ANDA ANDA091626 Sun Pharmaceutical Industries Limited EPINASTINE HYDROCHLORIDE .5 mg/mL Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] 62756-348_23f08ea3-8b3d-4019-a781-463b4cb1b7b5 62756-348 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20070814 ANDA ANDA077372 SUN PHARMACEUTICAL INDUSTRIES LIMITED OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 62756-349_23f08ea3-8b3d-4019-a781-463b4cb1b7b5 62756-349 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20070814 ANDA ANDA077372 SUN PHARMACEUTICAL INDUSTRIES LIMITED OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 62756-350_23f08ea3-8b3d-4019-a781-463b4cb1b7b5 62756-350 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20070814 ANDA ANDA077373 SUN PHARMACEUTICAL INDUSTRIES LIMITED OCTREOTIDE ACETATE 200 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 62756-351_23f08ea3-8b3d-4019-a781-463b4cb1b7b5 62756-351 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20070814 ANDA ANDA077372 SUN PHARMACEUTICAL INDUSTRIES LIMITED OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 62756-352_23f08ea3-8b3d-4019-a781-463b4cb1b7b5 62756-352 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20070814 ANDA ANDA077373 SUN PHARMACEUTICAL INDUSTRIES LIMITED OCTREOTIDE ACETATE 1000 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 62756-356_fd604c91-f150-48b4-971f-ae14184e8a4d 62756-356 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Sun Pharmaceutical Industries Limited ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 62756-368_aa103a04-7723-4c7c-99d8-a054e149115a 62756-368 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20120128 ANDA ANDA090654 Sun Pharmaceutical Industries Limited HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25; 100 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 62756-369_aa103a04-7723-4c7c-99d8-a054e149115a 62756-369 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20120128 ANDA ANDA090654 Sun Pharmaceutical Industries Limited HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 50; 100 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 62756-370_aa103a04-7723-4c7c-99d8-a054e149115a 62756-370 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20120128 ANDA ANDA090654 Sun Pharmaceutical Industries Limited HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25; 50 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 62756-402_16e78379-a0c3-49c3-8719-8ba7a666caab 62756-402 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20061212 ANDA ANDA040621 Sun Pharmaceutical Industries Limited PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-430_d3284649-ed4c-4096-987b-4ac16b8278f2 62756-430 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET ORAL 20100708 ANDA ANDA091027 Sun Pharmaceutical Industries Limited LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 62756-432_5c0df328-9b69-4898-8234-58dc1669d779 62756-432 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20080630 ANDA ANDA040731 SUN PHARMACEUTICAL INDUSTRIES LIMITED PHENYTOIN SODIUM 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-437_4126e980-1fd6-41ea-897e-67b2b744508f 62756-437 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET, FILM COATED ORAL 20110222 ANDA ANDA091552 Sun Pharmaceutical Industries Limited NARATRIPTAN HYDROCHLORIDE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 62756-440_79ad107b-bb20-4ed3-89f0-d7c862f3957c 62756-440 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110601 ANDA ANDA090493 Sun Pharmaceutical Industries Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 62756-445_79ad107b-bb20-4ed3-89f0-d7c862f3957c 62756-445 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110601 ANDA ANDA090493 Sun Pharmaceutical Industries Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 62756-446_6f0fc6d3-c27f-4d30-a2bd-1746ab1bc015 62756-446 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070227 ANDA ANDA040755 Sun Pharmaceutical Industries Limited CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 62756-457_293de977-3bd8-4334-a79e-05db01b2600f 62756-457 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE ORAL 20070823 ANDA ANDA077828 Sun Pharmaceutical Industries Limited CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 62756-461_293de977-3bd8-4334-a79e-05db01b2600f 62756-461 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE ORAL 20070823 ANDA ANDA077828 Sun Pharmaceutical Industries Limited CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 62756-511_3a61f626-c766-43ba-b3ff-93c4effeda11 62756-511 HUMAN PRESCRIPTION DRUG LETROZOLE LETROZOLE TABLET, FILM COATED ORAL 20110603 ANDA ANDA091466 Sun Pharmaceutical Industries Limited LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 62756-512_a24e5aae-e7f2-4db5-8ca5-1201e164f2f9 62756-512 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130403 ANDA ANDA090923 Sun Pharmaceutical Industries Limited AZITHROMYCIN MONOHYDRATE 500 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 62756-513_7f8a6319-0c81-46c4-a0e0-a771c141dcab 62756-513 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM INJECTION INTRAVENOUS 20100617 ANDA ANDA090754 Sun Pharmaceutical Industries Limited LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-517_6dce2c84-55b3-4923-9e4f-34341ed4dcd1 62756-517 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET ORAL 20081028 ANDA ANDA078536 Sun Pharmaceutical Industries Limited CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 62756-518_6dce2c84-55b3-4923-9e4f-34341ed4dcd1 62756-518 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET ORAL 20081028 ANDA ANDA078536 Sun Pharmaceutical Industries Limited CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 62756-519_6dce2c84-55b3-4923-9e4f-34341ed4dcd1 62756-519 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET ORAL 20081028 ANDA ANDA078536 Sun Pharmaceutical Industries Limited CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 62756-520_9485cc30-15e8-4b53-876d-db317145474b 62756-520 HUMAN PRESCRIPTION DRUG sumatriptan succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA078295 SUN PHARMACEUTICAL INDUSTRIES LIMITED SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 62756-521_9485cc30-15e8-4b53-876d-db317145474b 62756-521 HUMAN PRESCRIPTION DRUG sumatriptan succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA078295 SUN PHARMACEUTICAL INDUSTRIES LIMITED SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 62756-522_9485cc30-15e8-4b53-876d-db317145474b 62756-522 HUMAN PRESCRIPTION DRUG sumatriptan succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA078295 SUN PHARMACEUTICAL INDUSTRIES LIMITED SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 62756-523_0cf2d2c9-4fdc-4046-9ff4-6c6ad59330f2 62756-523 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET, FILM COATED ORAL 20101124 ANDA ANDA078359 Sun Pharmaceutical Industries Limited DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 62756-529_2dc2cec8-6953-4a33-9356-11534fba1fb8 62756-529 HUMAN PRESCRIPTION DRUG desmopressin acetate desmopressin acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140220 ANDA ANDA091280 Sun Pharmaceutical Industries Limited DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 62756-529_9fd48eec-aa24-4888-b99f-d409ada958a7 62756-529 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20130130 ANDA ANDA091280 Sun Pharmaceutical Industries Limited DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 62756-538_c5f35773-0a67-4068-8b59-f6f1f4970836 62756-538 HUMAN PRESCRIPTION DRUG Riluzole Riluzole TABLET, FILM COATED ORAL 20130618 ANDA ANDA091417 Sun Pharmaceutical Industries Limited RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] 62756-542_08192bed-4c4b-4947-96fb-6f2b3be1282d 62756-542 HUMAN OTC DRUG FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120206 ANDA ANDA091567 Sun Pharmaceutical Industries Limited FEXOFENADINE HYDROCHLORIDE 30 mg/1 62756-542_f071d190-0488-4943-bedc-6a612bced9d9 62756-542 HUMAN OTC DRUG FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120206 ANDA ANDA091567 Sun Pharmaceutical Industries Limited FEXOFENADINE HYDROCHLORIDE 30 mg/1 62756-543_08192bed-4c4b-4947-96fb-6f2b3be1282d 62756-543 HUMAN OTC DRUG FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120206 ANDA ANDA091567 Sun Pharmaceutical Industries Limited FEXOFENADINE HYDROCHLORIDE 60 mg/1 62756-543_f071d190-0488-4943-bedc-6a612bced9d9 62756-543 HUMAN OTC DRUG FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120206 ANDA ANDA091567 Sun Pharmaceutical Industries Limited FEXOFENADINE HYDROCHLORIDE 60 mg/1 62756-545_08192bed-4c4b-4947-96fb-6f2b3be1282d 62756-545 HUMAN OTC DRUG FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120206 ANDA ANDA091567 Sun Pharmaceutical Industries Limited FEXOFENADINE HYDROCHLORIDE 180 mg/1 62756-545_f071d190-0488-4943-bedc-6a612bced9d9 62756-545 HUMAN OTC DRUG FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120206 ANDA ANDA091567 Sun Pharmaceutical Industries Limited FEXOFENADINE HYDROCHLORIDE 180 mg/1 62756-551_9efb7e42-b900-45e2-97b4-07196913a93f 62756-551 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA091038 Sun Pharmaceutical Industries Limited OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 62756-552_9efb7e42-b900-45e2-97b4-07196913a93f 62756-552 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA091038 Sun Pharmaceutical Industries Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 62756-553_9efb7e42-b900-45e2-97b4-07196913a93f 62756-553 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA091038 Sun Pharmaceutical Industries Limited OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 62756-554_9efb7e42-b900-45e2-97b4-07196913a93f 62756-554 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA091038 Sun Pharmaceutical Industries Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 62756-555_9efb7e42-b900-45e2-97b4-07196913a93f 62756-555 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA091038 Sun Pharmaceutical Industries Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 62756-556_9efb7e42-b900-45e2-97b4-07196913a93f 62756-556 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA091038 Sun Pharmaceutical Industries Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 62756-580_c9f16065-a9d4-4566-b51a-d4d125f4f913 62756-580 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20141215 ANDA ANDA077058 Sun Pharmaceutical Industries Limited PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 62756-581_2a527ed0-3af2-41eb-9e8f-5b4783b37259 62756-581 HUMAN PRESCRIPTION DRUG AMIFOSTINE AMIFOSTINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080314 ANDA ANDA077126 Sun Pharmaceutical Industries Limited AMIFOSTINE 50 mg/mL 62756-633_3422dbd0-86d9-4d8a-aa70-1ce66e439ed7 62756-633 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20130413 ANDA ANDA078464 Sun Pharmaceutical Industries Limited RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 62756-634_3422dbd0-86d9-4d8a-aa70-1ce66e439ed7 62756-634 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20130413 ANDA ANDA078464 Sun Pharmaceutical Industries Limited RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 62756-700_3422dbd0-86d9-4d8a-aa70-1ce66e439ed7 62756-700 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20130413 ANDA ANDA078464 Sun Pharmaceutical Industries Limited RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 62756-701_3422dbd0-86d9-4d8a-aa70-1ce66e439ed7 62756-701 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20130413 ANDA ANDA078464 Sun Pharmaceutical Industries Limited RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 62756-702_3422dbd0-86d9-4d8a-aa70-1ce66e439ed7 62756-702 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20130413 ANDA ANDA078464 Sun Pharmaceutical Industries Limited RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 62756-707_20dec064-8e85-422f-a757-8b20bbd61a0a 62756-707 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Sun Pharmaceutical Industries Limited TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-710_20dec064-8e85-422f-a757-8b20bbd61a0a 62756-710 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Sun Pharmaceutical Industries Limited TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-711_20dec064-8e85-422f-a757-8b20bbd61a0a 62756-711 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Sun Pharmaceutical Industries Limited TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-712_20dec064-8e85-422f-a757-8b20bbd61a0a 62756-712 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Sun Pharmaceutical Industries Limited TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62756-718_3c7ee374-8820-41a3-a4e3-aa1c0c86e7cc 62756-718 HUMAN OTC DRUG Opcicon One-Step levonorgestrel TABLET ORAL 20140912 ANDA ANDA202635 Sun Pharmaceutical Industries Limited LEVONORGESTREL 1.5 mg/1 62756-751_f00a5b96-6fb0-475a-8ab1-11b9feb72de3 62756-751 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120228 ANDA ANDA090881 Sun Pharmaceutical Industries Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 62756-754_f00a5b96-6fb0-475a-8ab1-11b9feb72de3 62756-754 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120228 ANDA ANDA090881 Sun Pharmaceutical Industries Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 62756-755_f00a5b96-6fb0-475a-8ab1-11b9feb72de3 62756-755 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120228 ANDA ANDA090881 Sun Pharmaceutical Industries Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 62756-757_f00a5b96-6fb0-475a-8ab1-11b9feb72de3 62756-757 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120228 ANDA ANDA090881 Sun Pharmaceutical Industries Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 62756-761_82249dd9-57f1-49b7-a101-170dc511f3b8 62756-761 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20080226 ANDA ANDA078478 SUN PHARMACEUTICAL INDUSTRIES LIMITED TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 62756-762_82249dd9-57f1-49b7-a101-170dc511f3b8 62756-762 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20080226 ANDA ANDA078478 SUN PHARMACEUTICAL INDUSTRIES LIMITED TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 62756-763_82249dd9-57f1-49b7-a101-170dc511f3b8 62756-763 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20080226 ANDA ANDA078478 SUN PHARMACEUTICAL INDUSTRIES LIMITED TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 62756-764_82249dd9-57f1-49b7-a101-170dc511f3b8 62756-764 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20080226 ANDA ANDA078478 SUN PHARMACEUTICAL INDUSTRIES LIMITED TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 62756-796_3f944013-bad7-45f3-bf6a-eab39056b397 62756-796 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 Sun Pharmaceutical Industries Limited DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 62756-797_3f944013-bad7-45f3-bf6a-eab39056b397 62756-797 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 Sun Pharmaceutical Industries Limited DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 62756-798_3f944013-bad7-45f3-bf6a-eab39056b397 62756-798 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 Sun Pharmaceutical Industries Limited DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 62756-826_72831253-221f-4f03-9aa3-e91dc23fa2d9 62756-826 HUMAN PRESCRIPTION DRUG DOXOrubicin Hydrochloride DOXOrubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20120220 ANDA ANDA091418 Sun Pharmaceutical Industries Limited DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 62756-827_72831253-221f-4f03-9aa3-e91dc23fa2d9 62756-827 HUMAN PRESCRIPTION DRUG DOXOrubicin Hydrochloride DOXOrubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20120220 ANDA ANDA091418 Sun Pharmaceutical Industries Limited DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 62756-873_28f4552c-0a98-49ba-a071-cd139cd41f68 62756-873 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid CAPSULE ORAL 20130228 ANDA ANDA091037 Sun Pharmaceutical Industries Limited VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 62756-915_b3acabf6-1e01-43fe-98b1-268a65a9c939 62756-915 HUMAN OTC DRUG Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120929 ANDA ANDA090922 Sun Pharmaceutical Industries Limited CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 62785-001_ff6d9ee9-c90d-46be-b4c3-7fd150d3883c 62785-001 HUMAN OTC DRUG WATERMELON FROST SORE THROAT MENTHOL SPRAY ORAL 20140328 OTC MONOGRAPH NOT FINAL part356 GUILIN SANJIN PHARMACEUTICAL CO., LTD. MENTHOL 2 g/100mL 62789-0001_b3fe379f-a4c2-4564-8caf-e58b4f52df6d 62789-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040101 UNAPPROVED MEDICAL GAS THH Acquisition LLC I dba Total Home Health OXYGEN 99 L/100L 62795-1029_03e598d8-8da4-2dd0-e054-00144ff88e88 62795-1029 HUMAN OTC DRUG T Relief T Relief TABLET ORAL 20140901 UNAPPROVED HOMEOPATHIC MediNatura Inc ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA RECUTITA; RUTA GRAVEOLENS FLOWERING TOP 2; 3; 3; 3; 2; 2; 2; 8; 2; 2; 3; 2; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 62795-1030_0552629a-5bea-5329-e054-00144ff88e88 62795-1030 HUMAN OTC DRUG T Relief Arthritis T Relief Arthritis TABLET ORAL 20141001 UNAPPROVED HOMEOPATHIC Medinatura ARNICA MONTANA ROOT; BRYONIA ALBA ROOT; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF 3; 3; 7; 6; 8; 3; 2; 6; 4; 6; 6; 6; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 62802-010_8a774791-8a8c-4d5c-8077-b31eb04bb33a 62802-010 HUMAN OTC DRUG OP Dark Tanning Xtreme Oil Amplifier SPF4 octinoxate, octisalate SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 3; 2 mL/100mL; mL/100mL 62802-035_608fbdf5-9537-4103-a93f-6eddc678a227 62802-035 HUMAN OTC DRUG OP Dark Tanning Gel 4 octinoxate, octisalate SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 3; 2 mL/100mL; mL/100mL 62802-038_2a9663ac-477e-4516-bda6-9016ced432ab 62802-038 HUMAN OTC DRUG OP Protective Spray Gel 8 octinoxate, octisalate SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, Inc OCTINOXATE; OCTISALATE 4.5; 5 mL/100mL; mL/100mL 62802-039_1187aaeb-0487-4a72-97c8-aef4b86d356d 62802-039 HUMAN OTC DRUG OP Protective Gel 15 octinoxate, octisalate SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 7.5; 5 g/100g; g/100g 62802-085_d60a9658-b052-46af-8a13-f864b9fa36e5 62802-085 HUMAN OTC DRUG Ocean Potion Moisturizing Lip Potion 45 avobenzone, octisalate, octocrylene, oxybenzone, octinoxate LIPSTICK TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 7.5; 5; 5; 5 g/100g; g/100g; g/100g; g/100g; g/100g 62802-102_c476ddb7-2eb0-42ba-8b1b-312228340442 62802-102 HUMAN OTC DRUG Parrot Head Floridays 30 avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 12; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-103_9abf0f1f-792b-4f5d-abe2-9d95839b1d0b 62802-103 HUMAN OTC DRUG Parrot Head Floridays 50 avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-104_d2219616-7e13-4afc-a979-735b933dfd80 62802-104 HUMAN OTC DRUG Parrot Head Floridays Face 50 avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-106_8c9d655f-075b-4b5b-9948-42f594abe375 62802-106 HUMAN OTC DRUG Parrot Head Fins Up Sport 15 Mist Sunscreen avobenzone, homosalate,octisalate SPRAY TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE 1.2; 7.5; 5 mL/100mL; mL/100mL; mL/100mL 62802-107_d0e4cd05-b81a-4254-ae24-48b170dc85fc 62802-107 HUMAN OTC DRUG Parrot Head Fins Up Sport 30 Mist avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 13; 5; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-108_61d77960-daa2-494e-b0ce-fc50dbc98184 62802-108 HUMAN OTC DRUG Parrot Head Fins Up 50 Mist Sunscreen avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-109_10ff23e6-29f9-47db-a646-5480b9e227e5 62802-109 HUMAN OTC DRUG Parrot Head Fins Up Sport 15 avobenzone, homosalate,octisalate LOTION TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE 1.2; 7.5; 5 mL/100mL; mL/100mL; mL/100mL 62802-110_ef0ebaf0-1a9d-4993-99f9-d5b35852144b 62802-110 HUMAN OTC DRUG Parrot Head Fins Up Sport 30 avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 12; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-111_555665d0-16c7-4640-8c53-e08826138cbe 62802-111 HUMAN OTC DRUG Parrot Head Parakeet Kids 50 Mist Sunscreen avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-112_0573b990-25eb-4a84-9976-6be493040acc 62802-112 HUMAN OTC DRUG Parrot Head Parakeet Kids 50 avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-114_fb111532-83e3-49f1-99d0-327971b58890 62802-114 HUMAN OTC DRUG Parrot Head Dedicated to Sunshine Oil 4 octinoxate, octisalate SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 4.5; 5 mL/100mL; mL/100mL 62802-115_7a5dc6e3-3962-436b-9a60-2c8b5a881df9 62802-115 HUMAN OTC DRUG Parrot Head Dedicated to Sunshine Tan Enhancer 8 octinoxate, octisalate SPRAY TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 4.5; 5 mL/100mL; mL/100mL 62802-116_60b4c6af-f07a-447d-a5d4-d498ed5769e7 62802-116 HUMAN OTC DRUG Parrot Head Dedicated to Sunshine Tan Enhancer 15 octinoxate, octisalate SPRAY TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 7.5; 5 mL/100mL; mL/100mL 62802-140_d0795779-170b-4874-a15b-d445278909c2 62802-140 HUMAN OTC DRUG Ocean Potion Quick Dry 15 Sunscreen avobenzone, homosalate,octisalate LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE 1.2; 7.5; 5 mL/100mL; mL/100mL; mL/100mL 62802-144_c5667f67-27ac-44eb-bae0-61897db62c7e 62802-144 HUMAN OTC DRUG Ocean Potion Quick Dry SPF 70 Sunscreen avobenzone, homosalate, oxybenzone,octisalate, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 15; 5; 2; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-145_30a8923d-fea4-499a-bdae-1f8e21cca3f2 62802-145 HUMAN OTC DRUG Ocean Potion Quick Dry 30 Sunscreen avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 12; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-146_589aa513-327e-4d15-9785-130a59f92e22 62802-146 HUMAN OTC DRUG Ocean Potion Cool Dry Touch Sport 30 Sunscreen avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 12; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-147_763a1bf9-6c30-465c-8de8-3ae084a62182 62802-147 HUMAN OTC DRUG Ocean Potion Quick Dry 50 Sunscreen avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-148_a0c3225e-d4a4-49ac-ba7f-69e27d97eef3 62802-148 HUMAN OTC DRUG Ocean Potion Cool Dry Touch Sport 30 Sunscreen avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-150_1b1d58af-e181-4628-8f78-fb117dd6e7dc 62802-150 HUMAN OTC DRUG Ocean Potion Water Sport SPF50 Sunscreen avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-172_1134f978-a279-46e7-9bef-9fd648fa89a9 62802-172 HUMAN OTC DRUG Ocean Potion Instant Burn Relief Ice lidocaine GEL TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part348 Sun & Skin Care Research, LLC LIDOCAINE .5 g/100g 62802-182_238d0509-9233-4b5b-9a94-d6b6a3221e6f 62802-182 HUMAN OTC DRUG Ocean Potion Gentle and Sensitive 50 Sunscreen avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 g/100g; g/100g; g/100g; g/100g 62802-183_7d252d05-7a0e-41a0-a054-d07f972cfe58 62802-183 HUMAN OTC DRUG Ocean Potion Quick Dry Kids 50 Sunscreen avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-206_de85d956-6527-4d25-af8f-557a99c78dc0 62802-206 HUMAN OTC DRUG NO-AD SPF4 Dark Tanning Oil octinoxate, octisalate SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 3; 2 mL/100mL; mL/100mL 62802-208_8e75786a-93c4-468f-967d-61fd7d829e87 62802-208 HUMAN OTC DRUG NO-AD Dark Tanning SPF 4 octinoxate, octisalate LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 3; 2 g/100g; g/100g 62802-210_fe0ea217-9465-44c2-ba92-80db70ac4732 62802-210 HUMAN OTC DRUG NO-AD SPF 8 Tanning octinoxate, octisalate LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 4.5; 5 g/100g; g/100g 62802-212_d3949a7a-dcc2-40e3-814b-a3e3d0fda40a 62802-212 HUMAN OTC DRUG NO-AD 15 Sunscreen avobenzone, homosalate,octisalate LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE 1.2; 7.5; 5 mL/100mL; mL/100mL; mL/100mL 62802-213_53429f50-a195-4769-b3aa-7d493aaa8ac4 62802-213 HUMAN OTC DRUG NO-AD Splash 30 Sunscreen avobenzone, homosalate, octisalate, oxybenzone LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 2; 10; 5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-214_398ae829-1f70-4e66-aa18-dd2eeff06b32 62802-214 HUMAN OTC DRUG NO-AD 30 Sunscreen avobenzone, homosalate, octisalate, oxybenzone LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 2; 10; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-218_a06e565a-08f2-498f-b926-609b2faf1355 62802-218 HUMAN OTC DRUG NO-AD 45 Sunscreen avobenzone, homosalate, octisalate, oxybenzone LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 2; 15; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-220_11e4c5f7-48b6-4e9e-bd95-b761c45b5965 62802-220 HUMAN OTC DRUG NO-AD Sport 50 Sunscreen avobenzone, homosalate, octisalate, oxybenzone LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 2; 15; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-222_0debc631-c942-4669-9db1-986d55b83ca6 62802-222 HUMAN OTC DRUG NO-AD Kids 50 Sunscreen avobenzone, homosalate, octisalate, oxybenzone LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 2; 15; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-224_46f39437-deb5-45dd-8d22-17395b97619b 62802-224 HUMAN OTC DRUG NO-AD 60 Sunscreen avobenzone, homosalate, octisalate, oxybenzone LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 2; 15; 5; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-228_499ba605-1d25-49c0-961c-c2503a15982a 62802-228 HUMAN OTC DRUG NO-AD 85 Sunscreen avobenzone, homosalate, octisalate, oxybenzone, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g 62802-291_00731a42-a9fe-48d6-a225-735590554130 62802-291 HUMAN OTC DRUG NO-AD Kids SPF50 Continuous Mist Sunscreen avobenzone, homosalate, octisalate, oxybenzone, octocrylene SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 5 g/100g; g/100g; g/100g; g/100g; g/100g 62802-295_a47b6525-a4f2-4560-81c7-29b5a0835af7 62802-295 HUMAN OTC DRUG NO-AD Sport SPF30 Continuous Mist Sunscreen avobenzone, homosalate, octisalate, oxybenzone, octocrylene SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 2; 10; 5; 3 g/100g; g/100g; g/100g; g/100g 62802-301_d422013d-3ed1-4256-a379-c6b5e9504d17 62802-301 HUMAN OTC DRUG Ocean Potion Intell Mist 50 Kids Sunscreen avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 g/100g; g/100g; g/100g; g/100g 62802-362_d7f5c8a0-1dcb-4fda-a29f-40734e41cdfc 62802-362 HUMAN OTC DRUG Bull Frog Kids Sunscreen 35 avobenzone, homosalate, octisalate, oxybenzone, octocrylene LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 12; 5; 5 g/100g; g/100g; g/100g; g/100g 62802-390_ba962eaf-27af-49e0-a8da-1a9192404943 62802-390 HUMAN OTC DRUG Bull Frog Kids Mist 50 avobenzone, homosalate, octisalate, oxybenzone, octocrylene SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 5 g/100g; g/100g; g/100g; g/100g; g/100g 62802-406_1e1ef577-e0fa-4c30-8d52-173d708944d4 62802-406 HUMAN OTC DRUG Bull Frog Marathon Mist 36 avobenzone, homosalate, octisalate, oxybenzone, octocrylene SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 11; 5; 2; 5 g/100g; g/100g; g/100g; g/100g; g/100g 62802-495_87436d6c-0e15-480e-b8dc-1f3618c25b6b 62802-495 HUMAN OTC DRUG Bull Frog Marathon Mist 50 avobenzone, homosalate, octisalate, oxybenzone, octocrylene SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 5 g/100g; g/100g; g/100g; g/100g; g/100g 62802-501_6a724d70-e931-48aa-9e0b-bd096460be06 62802-501 HUMAN OTC DRUG NO-AD SPF45 Continuous Mist Sunscreen avobenzone, homosalate, octisalate, oxybenzone, octocrylene SPRAY TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 5 g/100g; g/100g; g/100g; g/100g; g/100g 62802-580_e50ed283-ec3e-4a7a-ac59-b7139e549cdb 62802-580 HUMAN OTC DRUG Ocean Potion Instant Dry 50 Dab-On Spotstick avobenzone, homosalate, octisalate, octocrylene LIQUID TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-581_5009f27d-a468-4aa3-94ac-4e57b7107c03 62802-581 HUMAN OTC DRUG Ocean Potion 50 Instant Dry Kid Spotstick avobenzone, homosalate, octisalate, octocrylene LIQUID TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-600_b9914b80-2352-42d3-899d-959ae2f5ef1e 62802-600 HUMAN OTC DRUG OP Dark Formula Xtreme Tanning 4 octinoxate, octisalate LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 3; 2 mL/100mL; mL/100mL 62802-644_29b3b675-0296-4222-b43a-2f16752715c0 62802-644 HUMAN OTC DRUG Ocean Potion Instant Dry 70 Mist Sunscreen avobenzone, homosalate, octisalate, octocrylene, oxybenzone SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 15; 5; 2; 6 g/100g; g/100g; g/100g; g/100g; g/100g 62802-646_3c280c0d-5fe2-4dbe-904d-58bc26ce1507 62802-646 HUMAN OTC DRUG Ocean Potion Instant Dry 30 Mist Sport Sunscreen avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 13; 5; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-647_dd61e764-eacb-4962-a972-bfe2f2f5cf69 62802-647 HUMAN OTC DRUG Ocean Potion Instant Dry 50 Mist Sunscreen avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-649_7420bb51-5dfe-40e9-936b-4943dc537bc5 62802-649 HUMAN OTC DRUG Bull Frog Water Armor Super 40 meradimate, octinoxate, octisalate, octocrylene, oxybenzone, titanium dixoide LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC MERADIMATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 5; 7.5; 5; 10; 6; 4.5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 62802-650_0491cf71-d9c9-4699-b6e9-cc20fa75761d 62802-650 HUMAN OTC DRUG Ocean Potion Instant Dry 30 Mist Water Sport Sunscreen avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 13; 5; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-651_239e1cac-5808-4082-a6e0-e6f3c34c6974 62802-651 HUMAN OTC DRUG Ocean Potion Instant Dry 30 Mist Water Sport Sunscreen avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 13; 5; 6 g/100g; g/100g; g/100g; g/100g 62802-653_1935a632-06d9-4c9f-8e92-98a78f177b8e 62802-653 HUMAN OTC DRUG Bull Frog Water Armor Sport Quik 50 avobenzone, homosalate, octisalate, oxybenzone, octocrylene GEL TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g 62802-668_6c05d663-b2ed-4301-9661-9dc509c274d9 62802-668 HUMAN OTC DRUG Bull Frog Insta-Cool Mist 50 avobenzone, homosalate, octisalate, oxybenzone, octocrylene SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 5 g/100g; g/100g; g/100g; g/100g; g/100g 62802-682_a10e6576-e0d5-41d7-9819-099909584618 62802-682 HUMAN OTC DRUG Ocean Potion Instant Dry 50 Mist Kids Sunscreen avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62802-683_dc39a032-d863-4961-bf5e-a13a100486b7 62802-683 HUMAN OTC DRUG Bull Frog Water Armor Sport 50 avobenzone, homosalate, octisalate, oxybenzone, octocrylene SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 5 g/100g; g/100g; g/100g; g/100g; g/100g 62802-690_efaf6a17-47fc-4872-9607-cfca6067d104 62802-690 HUMAN OTC DRUG OP Protective Xtreme Tanning 8 octinoxate, octisalate LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 4.5; 5 mL/100mL; mL/100mL 62802-773_eb7591c7-30fc-44fd-9855-65021ddc967c 62802-773 HUMAN OTC DRUG BULLFROG DEET FREE Mosquito Coast Sunscreen with Insect Repellent SPF 30 Octinoxate, homosalate, octisalate, octocrylene SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 10; 6 g/100g; g/100g; g/100g; g/100g 62802-915_05b9a012-d1ab-41e1-b9ec-a26f3332c091 62802-915 HUMAN OTC DRUG OP Protective Mist 15 Oil Free octinoxate, octisalate SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 7; 5 mL/100mL; mL/100mL 62806-0001_24fae211-5eeb-48b4-9aa6-75303289cdc0 62806-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19880101 UNAPPROVED MEDICAL GAS Wright & Filippis, Inc. OXYGEN 99 L/100L 62818-100_3981a814-dfa8-4e1b-8f6f-33c45185aed6 62818-100 HUMAN OTC DRUG Vegetability Natural Pyrithione Zinc SHAMPOO TOPICAL 20140501 OTC MONOGRAPH FINAL part358H Biometics Co.,Ltd. PYRITHIONE ZINC 5 g/500g 62818-101_041856fa-1f3e-4a4b-ba5a-f9326e9c620d 62818-101 HUMAN OTC DRUG Acne Solution salicylic acid SOLUTION TOPICAL 20140501 OTC MONOGRAPH FINAL part333D Biometics Co.,Ltd. SALICYLIC ACID .2 g/40g 62818-102_61c0af32-1b3f-4d55-baf3-b709a9d3dc66 62818-102 HUMAN OTC DRUG AtoQ30 Solution Colloidal Oatmeal SOLUTION TOPICAL 20140501 20240501 OTC MONOGRAPH FINAL part347 Biometics Co.,Ltd. OATMEAL .8 g/40g 62835-689_28466162-800f-4bc1-8321-09a2bc7c3863 62835-689 HUMAN OTC DRUG Growth Hormone Liver Extract, HGH Somatotropin, Pituitarum Extract LIQUID ORAL 20140501 UNAPPROVED HOMEOPATHIC Midlink LLC PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62839-0125_fbcc7ce6-3076-4f0b-9ce0-f2cc076114d7 62839-0125 HUMAN OTC DRUG Nu Skin 180 Degree UV Block Hydrator SPF 18 Octinoxate and Zinc Oxide LOTION TOPICAL 20010610 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; ZINC OXIDE 7.5; 5.2705 mL/100mL; mL/100mL 62839-0138_454ae770-e9cb-4796-bc90-d00945e03ddb 62839-0138 HUMAN OTC DRUG Nu Skin Clear Action Acne Medication Toner Salicylic Acid LIQUID TOPICAL 20020125 OTC MONOGRAPH FINAL part333D NSE Products, Inc. SALICYLIC ACID .5 mL/100mL 62839-0271_9f2f5ced-284b-494b-97e2-39c658eba2a8 62839-0271 HUMAN OTC DRUG Nu Skin Antibacterial Body Cleansing Triclosan GEL TOPICAL 19960826 OTC MONOGRAPH NOT FINAL part333E NSE Products, Inc. TRICLOSAN .55 mL/100mL 62839-0272_73149c73-82c1-4389-a267-2129d87d6f98 62839-0272 HUMAN OTC DRUG Moisture Restore Day Protective Mattefying Broad Spectrum SPF15 Combination to Oily Octinoxate, Octisalate, and Titanium Dioxide LOTION TOPICAL 20010610 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 30; 28 mg/mL; mg/mL; mg/mL 62839-0273_34287e3f-f79d-4496-a549-64b59d755dba 62839-0273 HUMAN OTC DRUG Nu Skin Tri-Phasic White Day Milk Broad Spectrum SPF 15 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 24; 74; 30 mg/mL; mg/mL; mg/mL 62839-0289_346d1b9f-d977-43c4-8794-a317dbcb8c55 62839-0289 HUMAN OTC DRUG NU SKIN ageLOC Radiant Day SPF 22 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 4; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 62839-0369_efb19f26-a0fc-4f72-9243-caed20a327c9 62839-0369 HUMAN OTC DRUG Nu Skin Sunright Lip Balm Broad Spectrum SPF 15 Octinoxate and Octocrylene STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTOCRYLENE 75; 27.9 mg/mL; mg/mL 62839-0388_cfac745b-03ed-4082-b13a-fbaa99ac6eb7 62839-0388 HUMAN OTC DRUG Nu Skin Clear Action Acne Medication Foaming Cleanser Salicylic Acid LOTION TOPICAL 20100901 OTC MONOGRAPH FINAL part333D NSE Products, Inc. SALICYLIC ACID 5 g/1000mL 62839-0390_a0e5a958-f9a4-488b-bc19-eb591e299cfe 62839-0390 HUMAN OTC DRUG Nu Skin Clear Action Acne Medication Night Treatment Salicylic Acid GEL TOPICAL 20100901 OTC MONOGRAPH FINAL part333D NSE Products, Inc. SALICYLIC ACID 5 g/1000mL 62839-0802_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0802 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Delicate Ivory Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL 62839-0803_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0803 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Shell Rose Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL 62839-0804_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0804 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Natural Beige Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL 62839-0805_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0805 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Honey Beige Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL 62839-0806_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0806 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Golden Beige Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL 62839-0807_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0807 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Sunset Beige Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL 62839-0808_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0808 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Sandalwood Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL 62839-0811_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0811 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Saffron Whisper Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL 62839-0812_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0812 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Amber Mist Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL 62839-0820_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0820 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Caramel Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL 62839-0853_da77156c-8085-461b-a468-995842ec862a 62839-0853 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Neutral Beige Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL 62839-0854_da77156c-8085-461b-a468-995842ec862a 62839-0854 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Soft Beige Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL 62839-0855_da77156c-8085-461b-a468-995842ec862a 62839-0855 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Delicate Ivory Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL 62839-0856_da77156c-8085-461b-a468-995842ec862a 62839-0856 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Sunny Beige Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL 62839-0857_da77156c-8085-461b-a468-995842ec862a 62839-0857 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Almond Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL 62839-0858_da77156c-8085-461b-a468-995842ec862a 62839-0858 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Sunset Beige Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL 62839-0859_da77156c-8085-461b-a468-995842ec862a 62839-0859 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Tawny Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL 62839-0860_da77156c-8085-461b-a468-995842ec862a 62839-0860 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Mocha Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL 62839-0861_da77156c-8085-461b-a468-995842ec862a 62839-0861 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Honey Beige Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL 62839-0862_da77156c-8085-461b-a468-995842ec862a 62839-0862 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Beige Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL 62839-0863_da77156c-8085-461b-a468-995842ec862a 62839-0863 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Ochre Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL 62839-0864_da77156c-8085-461b-a468-995842ec862a 62839-0864 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Pink Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL 62839-0865_da77156c-8085-461b-a468-995842ec862a 62839-0865 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Pink Ochre Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL 62839-0866_da77156c-8085-461b-a468-995842ec862a 62839-0866 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Medium Ochre Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL 62839-0867_da77156c-8085-461b-a468-995842ec862a 62839-0867 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Medium Beige Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL 62839-1038_aa426afc-1024-4afa-9d4c-12a5a4ab559f 62839-1038 HUMAN OTC DRUG Nu Skin Clear Action Acne Medication Day Treatment Salicylic Acid GEL TOPICAL 20020125 OTC MONOGRAPH FINAL part333D NSE Products, Inc. SALICYLIC ACID 5 g/1000mL 62839-1083_fc911b92-e1a2-418f-98f9-49b3fb87b11c 62839-1083 HUMAN OTC DRUG Epoch Alcohol GEL TOPICAL 20090601 OTC MONOGRAPH NOT FINAL part333E NSE Products, Inc. ALCOHOL 61.9937 mL/100mL 62839-1084_7f2655d9-d393-4c71-b29a-c6f24dcaf5cd 62839-1084 HUMAN OTC DRUG Epoch Salicylic Acid GEL TOPICAL 20010610 OTC MONOGRAPH FINAL part333D NSE Products, Inc. SALICYLIC ACID 20 g/1000mL 62839-1101_a5944d01-79d1-4ee8-8a81-4d239c8ec2ec 62839-1101 HUMAN OTC DRUG Nu Skin Nu Colour Tinted Moisturizer Broad Spectrum SPF 15 Fair Octinoxate and Octisalate LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 20 mg/mL; mg/mL 62839-1102_a5944d01-79d1-4ee8-8a81-4d239c8ec2ec 62839-1102 HUMAN OTC DRUG Nu Skin Nu Colour Tinted Moisturizer Broad Spectrum SPF 15 Sand Octinoxate and Octisalate LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 20 mg/mL; mg/mL 62839-1103_a5944d01-79d1-4ee8-8a81-4d239c8ec2ec 62839-1103 HUMAN OTC DRUG Nu Skin Nu Colour Tinted Moisturizer Broad Spectrum SPF 15 Honey Octinoxate and Octisalate LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 20 mg/mL; mg/mL 62839-1104_a5944d01-79d1-4ee8-8a81-4d239c8ec2ec 62839-1104 HUMAN OTC DRUG Nu Skin Nu Colour Tinted Moisturizer Broad Spectrum SPF 15 Beige Octinoxate and Octisalate LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 20 mg/mL; mg/mL 62839-1113_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1113 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Fair Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL 62839-1114_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1114 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Sand Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL 62839-1115_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1115 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Honey Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL 62839-1116_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1116 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Beige Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL 62839-1133_889448cd-8752-41eb-b71c-56650df08198 62839-1133 HUMAN OTC DRUG Sunright BodyBlock SPF15 Avobenzone, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 g/1000mL; g/1000mL; g/1000mL; g/1000mL 62839-1135_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1135 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Ochre Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL 62839-1136_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1136 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Pink Ochre Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL 62839-1137_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1137 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Medium Ochre Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL 62839-1138_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1138 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Pink Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL 62839-1139_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1139 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Natural Beige Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL 62839-1140_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1140 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Medium Beige Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL 62839-1254_3ea9a803-714f-4985-b279-e1aac88d45af 62839-1254 HUMAN OTC DRUG Nu Skin 180 Degree UV Defense Hydrator SPF 18 Octinoxate and Zinc Oxide LOTION TOPICAL 20130801 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; ZINC OXIDE 75; 54 mg/mL; mg/mL 62839-1332_a473dba0-18a6-4749-88ba-63697e6ed174 62839-1332 HUMAN OTC DRUG Sunright Broad Spectrum SPF 30 Avobenzone, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL 62839-1344_55a4c68b-22fa-41c9-b457-0bb9322bae71 62839-1344 HUMAN OTC DRUG Nu Skin Sunright 35 Broad Spectrum SPF 35 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20140423 OTC MONOGRAPH FINAL part352 NSE Products, Inc. TITANIUM DIOXIDE; ZINC OXIDE 42; 45 mg/mL; mg/mL 62839-1345_34289de8-2922-4dbb-adf5-a4bf88cd69eb 62839-1345 HUMAN OTC DRUG Nu Skin Sunright 50 Broad Spectrum SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20140602 OTC MONOGRAPH FINAL part352 NSE Products, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 100; 75; 50; 65 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 62839-1455_8dfb7c49-722e-49e7-af3c-a20733cbc5cd 62839-1455 HUMAN OTC DRUG Dividends Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20030107 OTC MONOGRAPH FINAL part350 NSE Products, Inc. ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g 62839-2728_2b387dff-ac60-43f4-a8e8-73f6891ce5c4 62839-2728 HUMAN OTC DRUG Nu Skin Moisture Restore Day Protective Lotion SPF 15 Normal to Dry Skin Octinoxate and Titanium Dioxide LOTION TOPICAL 20010610 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; TITANIUM DIOXIDE 75; 38 g/1000mL; g/1000mL 62839-2734_71dbd24f-cd19-42f4-bd0f-4c9afc0513e3 62839-2734 HUMAN OTC DRUG Nu Skin Tri-Phasic White System Avobenzone, Octinoxate, and Octisalate KIT 20130401 OTC MONOGRAPH FINAL part352 NSE Products, Inc. 62839-2810_5621ab47-a70b-4439-bef1-e644d4a3ce31 62839-2810 HUMAN OTC DRUG Epoch Ava Puhi Moni Pyrithione Zinc SHAMPOO TOPICAL 20091001 OTC MONOGRAPH FINAL part358H NSE Products, Inc. PYRITHIONE ZINC 10 mL/1000mL 62839-3887_dcbdfbbb-ba33-42c1-a9eb-a86de58c5d7c 62839-3887 HUMAN OTC DRUG ageLOC Elements Avobenzone, Homosalate, Octisalate, and Octocrylene KIT 20130501 OTC MONOGRAPH FINAL part352 NSE Products, Inc. 62839-3888_521a7d0e-788e-4da5-bf03-6a2efebf9989 62839-3888 HUMAN OTC DRUG ageLOC Transformation Avobenzone, Homosalate, Octisalate, and Octocrylene KIT 20130501 OTC MONOGRAPH FINAL part352 NSE Products, Inc. 62839-3904_a6a09841-bb56-46ca-9672-0c5f334965b6 62839-3904 HUMAN OTC DRUG Nu Skin ageLOC Radiant Day Broad Spectrum SPF 22 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20130501 OTC MONOGRAPH FINAL part352 NSE Products, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL 62847-001_90eb3a09-c412-421c-8a8a-185741ca0be8 62847-001 HUMAN PRESCRIPTION DRUG Vibativ telavancin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091105 NDA NDA022110 Theravance Biopharma Antibiotics, Inc. TELAVANCIN HYDROCHLORIDE 15 mg/mL 62847-002_90eb3a09-c412-421c-8a8a-185741ca0be8 62847-002 HUMAN PRESCRIPTION DRUG Vibativ telavancin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091105 NDA NDA022110 Theravance Biopharma Antibiotics, Inc. TELAVANCIN HYDROCHLORIDE 15 mg/mL 62856-001_81007003-bba4-467e-b643-08f1101258c9 62856-001 HUMAN PRESCRIPTION DRUG Hexalen altretamine CAPSULE ORAL 19901226 NDA NDA019926 Eisai Inc. ALTRETAMINE 50 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 62856-100_1bdee21b-6beb-4a5a-a24b-12c5fcada4f8 62856-100 HUMAN PRESCRIPTION DRUG Fragmin dalteparin sodium INJECTION SUBCUTANEOUS 19941222 NDA NDA020287 Eisai Inc. DALTEPARIN SODIUM 10000 [iU]/.4mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62856-101_1bdee21b-6beb-4a5a-a24b-12c5fcada4f8 62856-101 HUMAN PRESCRIPTION DRUG Fragmin dalteparin sodium INJECTION SUBCUTANEOUS 19941222 NDA NDA020287 Eisai Inc. DALTEPARIN SODIUM 10000 [iU]/mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62856-102_1bdee21b-6beb-4a5a-a24b-12c5fcada4f8 62856-102 HUMAN PRESCRIPTION DRUG Fragmin dalteparin sodium INJECTION SUBCUTANEOUS 19941222 NDA NDA020287 Eisai Inc. DALTEPARIN SODIUM 10000 [iU]/mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62856-125_1bdee21b-6beb-4a5a-a24b-12c5fcada4f8 62856-125 HUMAN PRESCRIPTION DRUG Fragmin dalteparin sodium INJECTION SUBCUTANEOUS 19941222 NDA NDA020287 Eisai Inc. DALTEPARIN SODIUM 12500 [iU]/.5mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62856-150_1bdee21b-6beb-4a5a-a24b-12c5fcada4f8 62856-150 HUMAN PRESCRIPTION DRUG Fragmin dalteparin sodium INJECTION SUBCUTANEOUS 19941222 NDA NDA020287 Eisai Inc. DALTEPARIN SODIUM 15000 [iU]/.6mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62856-177_783ec80b-95d7-44c7-8b90-fa7394f50f67 62856-177 HUMAN PRESCRIPTION DRUG Gliadel polifeprosan 20 with carmustine implant WAFER INTRACAVITARY 19960924 NDA NDA020637 Eisai Inc. CARMUSTINE 7.7 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 62856-180_1bdee21b-6beb-4a5a-a24b-12c5fcada4f8 62856-180 HUMAN PRESCRIPTION DRUG Fragmin dalteparin sodium INJECTION SUBCUTANEOUS 19941222 NDA NDA020287 Eisai Inc. DALTEPARIN SODIUM 18000 [iU]/.72mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62856-243_ae6e8f4e-6726-4388-a4a5-f8460f0aca53 62856-243 HUMAN PRESCRIPTION DRUG AcipHex rabeprazole sodium TABLET, DELAYED RELEASE ORAL 19990819 NDA NDA020973 Eisai Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 62856-245_b89b59cc-0cae-4768-a167-4e2a0b8f3aeb 62856-245 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 19961125 NDA NDA020690 Eisai Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 62856-246_b89b59cc-0cae-4768-a167-4e2a0b8f3aeb 62856-246 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 19961125 NDA NDA020690 Eisai Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 62856-247_b89b59cc-0cae-4768-a167-4e2a0b8f3aeb 62856-247 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 20100723 NDA NDA022568 Eisai Inc. DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 62856-250_1bdee21b-6beb-4a5a-a24b-12c5fcada4f8 62856-250 HUMAN PRESCRIPTION DRUG Fragmin dalteparin sodium INJECTION SUBCUTANEOUS 19941222 NDA NDA020287 Eisai Inc. DALTEPARIN SODIUM 2500 [iU]/.2mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62856-251_1bdee21b-6beb-4a5a-a24b-12c5fcada4f8 62856-251 HUMAN PRESCRIPTION DRUG Fragmin dalteparin sodium INJECTION SUBCUTANEOUS 19941222 NDA NDA020287 Eisai Inc. DALTEPARIN SODIUM 25000 [iU]/mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62856-270_4c337daf-3501-43f3-bb93-f44e8b4a3fe2 62856-270 HUMAN PRESCRIPTION DRUG Fycompa perampanel KIT 20121022 NDA NDA202834 Eisai Inc. CIII 62856-272_4c337daf-3501-43f3-bb93-f44e8b4a3fe2 62856-272 HUMAN PRESCRIPTION DRUG Fycompa perampanel TABLET ORAL 20121022 NDA NDA202834 Eisai Inc. PERAMPANEL 2 mg/1 Noncompetitive AMPA Glutamate Receptor Antagonist [EPC],AMPA Receptor Antagonists [MoA] CIII 62856-274_4c337daf-3501-43f3-bb93-f44e8b4a3fe2 62856-274 HUMAN PRESCRIPTION DRUG Fycompa perampanel TABLET ORAL 20121022 NDA NDA202834 Eisai Inc. PERAMPANEL 4 mg/1 Noncompetitive AMPA Glutamate Receptor Antagonist [EPC],AMPA Receptor Antagonists [MoA] CIII 62856-276_4c337daf-3501-43f3-bb93-f44e8b4a3fe2 62856-276 HUMAN PRESCRIPTION DRUG Fycompa perampanel TABLET ORAL 20121022 NDA NDA202834 Eisai Inc. PERAMPANEL 6 mg/1 Noncompetitive AMPA Glutamate Receptor Antagonist [EPC],AMPA Receptor Antagonists [MoA] CIII 62856-278_4c337daf-3501-43f3-bb93-f44e8b4a3fe2 62856-278 HUMAN PRESCRIPTION DRUG Fycompa perampanel TABLET ORAL 20121022 NDA NDA202834 Eisai Inc. PERAMPANEL 8 mg/1 Noncompetitive AMPA Glutamate Receptor Antagonist [EPC],AMPA Receptor Antagonists [MoA] CIII 62856-280_4c337daf-3501-43f3-bb93-f44e8b4a3fe2 62856-280 HUMAN PRESCRIPTION DRUG Fycompa perampanel TABLET ORAL 20121022 NDA NDA202834 Eisai Inc. PERAMPANEL 10 mg/1 Noncompetitive AMPA Glutamate Receptor Antagonist [EPC],AMPA Receptor Antagonists [MoA] CIII 62856-282_4c337daf-3501-43f3-bb93-f44e8b4a3fe2 62856-282 HUMAN PRESCRIPTION DRUG Fycompa perampanel TABLET ORAL 20121022 NDA NDA202834 Eisai Inc. PERAMPANEL 12 mg/1 Noncompetitive AMPA Glutamate Receptor Antagonist [EPC],AMPA Receptor Antagonists [MoA] CIII 62856-350_1ac5f878-e390-4b8c-b0b1-410c1a3187b4 62856-350 HUMAN PRESCRIPTION DRUG LUSEDRA fospropofol disodium INJECTION INTRAVENOUS 20081212 NDA NDA022244 Eisai, Inc FOSPROPOFOL DISODIUM 35 mg/mL CIV 62856-389_f058909f-856e-41ec-a451-7067bf62ccca 62856-389 HUMAN PRESCRIPTION DRUG Halaven eribulin mesylate INJECTION INTRAVENOUS 20101115 NDA NDA201532 Eisai Inc. ERIBULIN MESYLATE .5 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 62856-500_1bdee21b-6beb-4a5a-a24b-12c5fcada4f8 62856-500 HUMAN PRESCRIPTION DRUG Fragmin dalteparin sodium INJECTION SUBCUTANEOUS 19941222 NDA NDA020287 Eisai Inc. DALTEPARIN SODIUM 5000 [iU]/.2mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62856-529_124ac269-7687-4ad9-afbb-69be54f80064 62856-529 HUMAN PRESCRIPTION DRUG Belviq lorcaserin hydrochloride hemihydrate TABLET ORAL 20120627 NDA NDA022529 Eisai Inc. LORCASERIN HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin-2c Receptor Agonist [EPC],Serotonin 2c Receptor Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA] CIV 62856-582_159e4912-36f9-4c6c-b9de-e0d875b2b5d3 62856-582 HUMAN PRESCRIPTION DRUG Banzel rufinamide TABLET, FILM COATED ORAL 20081114 NDA NDA021911 Eisai Inc. RUFINAMIDE 200 mg/1 62856-583_159e4912-36f9-4c6c-b9de-e0d875b2b5d3 62856-583 HUMAN PRESCRIPTION DRUG Banzel rufinamide TABLET, FILM COATED ORAL 20081114 NDA NDA021911 Eisai Inc. RUFINAMIDE 400 mg/1 62856-584_159e4912-36f9-4c6c-b9de-e0d875b2b5d3 62856-584 HUMAN PRESCRIPTION DRUG Banzel rufinamide SUSPENSION ORAL 20110303 NDA NDA201367 Eisai Inc. RUFINAMIDE 40 mg/mL 62856-600_9178b403-6b09-47f8-a88c-f2a58e1d06c9 62856-600 HUMAN PRESCRIPTION DRUG Dacogen decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19960503 NDA NDA021790 Eisai Inc. DECITABINE 50 mg/20mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 62856-601_4e6e9992-040c-448b-954b-514383c92265 62856-601 HUMAN PRESCRIPTION DRUG Panretin alitretinoin GEL TOPICAL 19990203 NDA NDA020886 Eisai Inc. ALITRETINOIN 60 mg/60g Retinoid [EPC],Retinoids [Chemical/Ingredient] 62856-602_2c788388-1b3d-4f31-9888-2ff0ce6f12fb 62856-602 HUMAN PRESCRIPTION DRUG Targretin bexarotene CAPSULE, LIQUID FILLED ORAL 19991229 NDA NDA021055 Eisai Inc. BEXAROTENE 75 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 62856-603_f2eba925-c3a4-45db-a391-23e7a11bdb24 62856-603 HUMAN PRESCRIPTION DRUG Ontak denileukin diftitox INJECTION, SOLUTION INTRAVENOUS 20081015 BLA BLA103767 Eisai Inc. DENILEUKIN DIFTITOX 150 ug/mL CD25-directed Cytotoxin [EPC],Diphtheria Toxin [Chemical/Ingredient],Interleukin-2 [Chemical/Ingredient],Recombinant Fusion Proteins [Chemical/Ingredient] 62856-604_8ad47a65-a73d-4528-b058-c4cf58df5601 62856-604 HUMAN PRESCRIPTION DRUG Targretin bexarotene GEL TOPICAL 20000628 NDA NDA021056 Eisai Inc. BEXAROTENE 1 g/100g Retinoid [EPC],Retinoids [Chemical/Ingredient] 62856-680_e07ddc93-ce30-4fe2-ae86-a56dd8a4919a 62856-680 HUMAN PRESCRIPTION DRUG Zonegran zonisamide CAPSULE, LIQUID FILLED ORAL 20000327 NDA NDA020789 Eisai Inc. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62856-681_e07ddc93-ce30-4fe2-ae86-a56dd8a4919a 62856-681 HUMAN PRESCRIPTION DRUG Zonegran zonisamide CAPSULE, LIQUID FILLED ORAL 20000327 NDA NDA020789 Eisai Inc. ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 62856-705_fb4810ec-d26f-429d-b87c-5898a7870169 62856-705 HUMAN PRESCRIPTION DRUG Salagen pilocarpine hyrochloride TABLET, FILM COATED ORAL 19940322 NDA NDA020237 Eisai Inc. PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 62856-750_1bdee21b-6beb-4a5a-a24b-12c5fcada4f8 62856-750 HUMAN PRESCRIPTION DRUG Fragmin dalteparin sodium INJECTION SUBCUTANEOUS 19941222 NDA NDA020287 Eisai Inc. DALTEPARIN SODIUM 7500 [iU]/.3mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] 62856-775_fb4810ec-d26f-429d-b87c-5898a7870169 62856-775 HUMAN PRESCRIPTION DRUG Salagen pilocarpine hyrochloride TABLET, FILM COATED ORAL 19940322 NDA NDA020237 Eisai Inc. PILOCARPINE HYDROCHLORIDE 7.5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 62856-796_c32b5709-e753-4052-a227-4793bf1a3fea 62856-796 HUMAN PRESCRIPTION DRUG AKYNZEO Netupitant and Palonosetron CAPSULE ORAL 20141013 NDA NDA205718 Eisai Inc. NETUPITANT; PALONOSETRON 300; .5 mg/1; mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 62856-797_56af5f60-5aeb-451d-8989-608cc54d90d3 62856-797 HUMAN PRESCRIPTION DRUG Aloxi palonosetron hydrochloride INJECTION INTRAVENOUS 20140528 NDA NDA021372 Eisai Inc. PALONOSETRON HYDROCHLORIDE .25 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 62856-798_56af5f60-5aeb-451d-8989-608cc54d90d3 62856-798 HUMAN PRESCRIPTION DRUG Aloxi palonosetron hydrochloride INJECTION INTRAVENOUS 20140528 NDA NDA021372 Eisai Inc. PALONOSETRON HYDROCHLORIDE .075 mg/1.5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 62856-799_3b51614c-4d17-4635-980e-f9edb278ff9d 62856-799 HUMAN PRESCRIPTION DRUG ALOXI palonosetron hydrochloride CAPSULE, GELATIN COATED ORAL 20080822 NDA NDA022233 Eisai Inc. PALONOSETRON HYDROCHLORIDE .5 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 62856-831_b89b59cc-0cae-4768-a167-4e2a0b8f3aeb 62856-831 HUMAN PRESCRIPTION DRUG Aricept ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20041018 NDA NDA021720 Eisai Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 62856-832_b89b59cc-0cae-4768-a167-4e2a0b8f3aeb 62856-832 HUMAN PRESCRIPTION DRUG Aricept ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20041018 NDA NDA021720 Eisai Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 62858-101_2f822bdd-6cbc-46f7-b3e1-5e84a2dd6fd3 62858-101 HUMAN OTC DRUG NAIL RENEW TOLNAFTATE LIQUID TOPICAL 20140322 OTC MONOGRAPH FINAL part333C NailRenew TOLNAFTATE 1 g/100mL 62864-662_0a93d029-38d0-00d6-e054-00144ff88e88 62864-662 HUMAN OTC DRUG Truly Radiant Whitening and Strengthening Rinse Sodium Fluoride 0.02% LIQUID ORAL 20141023 OTC MONOGRAPH FINAL part355 Church & Dwight Canada Corp SODIUM FLUORIDE .2 mg/mL 62864-759_061840ed-24f2-0b4e-e054-00144ff8d46c 62864-759 HUMAN OTC DRUG Orajel Alcohol Free Antiseptic Rinse For All Mouth Sores Hydrogen Peroxide 1.5%, Menthol 0.1% LIQUID ORAL 20141101 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Canada Corp HYDROGEN PEROXIDE; MENTHOL 1.5; 1 mL/mL; mg/mL 62864-760_0618c1d8-5c91-1e88-e054-00144ff8d46c 62864-760 HUMAN OTC DRUG Orajel Antiseptic Rinse For All Mouth Sores Hydrogen Peroxide 1.5%, Menthol 0.1% LIQUID ORAL 20141101 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Canada Corp. HYDROGEN PEROXIDE; MENTHOL 1.5; 1 mL/mL; mg/mL 62864-900_18f6f9d9-d932-49ba-a75d-04c8f5ba6f86 62864-900 HUMAN OTC DRUG UltraMax Roll On Antiperspirant Deodorant Powder Fresh Aluminum Zirconium Tetrachlorohydrex Gly LIQUID TOPICAL 20000728 OTC MONOGRAPH FINAL part350 Church & Dwight Canada Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 21 g/100mL 62864-901_d8abada4-8cf0-4e30-aa10-9f14fde0f1a7 62864-901 HUMAN OTC DRUG ARRID XX Roll On Antiperspirant Deodorant Regular Aluminum Chlorohydrate LIQUID TOPICAL 19960716 OTC MONOGRAPH FINAL part350 .Church & Dwight Canada Corp ALUMINUM CHLOROHYDRATE 16 mL/100mL 62864-902_f91001e0-66a2-494c-9faf-96bb62c248bc 62864-902 HUMAN OTC DRUG ARRID Extra Dry Antiperspirant Deodorant Aluminum Sesquichlorohydrate 17% CREAM TOPICAL 19951108 OTC MONOGRAPH FINAL part350 Church & Dwight Canada Corp. ALUMINUM SESQUICHLOROHYDRATE 170 mg/g 62864-903_f440cc78-ae2c-4a0e-a36d-eb9a22c55349 62864-903 HUMAN OTC DRUG Baby Orajel Naturals for Teething Pain Relief Calcarea phosphorica, Coffea cruda, Chamomilla TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20110615 UNAPPROVED HOMEOPATHIC Church & Dwight Canada Corp. ARABICA COFFEE BEAN; MATRICARIA RECUTITA; TRIBASIC CALCIUM PHOSPHATE 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 62868-221_0d118afd-348a-4981-9ce5-34aa052333f0 62868-221 HUMAN OTC DRUG GKhair Anti-Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20140409 OTC MONOGRAPH FINAL part358H Van Tibolli Beauty Corp. PYRITHIONE ZINC 1 g/100mL 62870-000_5fc89013-20e4-4715-a9ba-c421243eb534 62870-000 HUMAN OTC DRUG Agropharma Isopropyl Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part333A AGROPHARMA LABORATORIES INC ISOPROPYL ALCOHOL 70 mL/100mL 62870-041_0ea6926b-0864-40ce-b576-68b3a2313e25 62870-041 HUMAN OTC DRUG Agropharma Isopropyl Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part333A AGROPHARMA LABORATORIES INC ISOPROPYL ALCOHOL 70 mL/100mL 62872-766_ef9dbeb6-6506-4f0d-a3c0-10c95a7b3e03 62872-766 HUMAN OTC DRUG TOM FORD TRACELESS FOUNDATION SPF 15 OCTINOXATE LIQUID TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER N.V. OCTINOXATE 2.2 mL/100mL 62874-005_27ede3b3-4b21-4a71-a6cd-9dbbff8a2161 62874-005 HUMAN OTC DRUG VITAMIN E DAY SPF 15 OCTISALATE, AVOBENZONE CREAM TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 JO MALONE LTD AVOBENZONE; OCTISALATE 3; 5 mL/100mL; mL/100mL 62874-995_aefb9f8c-1f64-4e3a-ba7a-eb079910e6f6 62874-995 HUMAN OTC DRUG VITAMIN E LIP CONDITIONER SPF 15 OCTINOXATE, OCTISALATE CREAM TOPICAL 20030901 OTC MONOGRAPH NOT FINAL part352 JO MALONE LTD, Distr. OCTINOXATE; OCTISALATE 7.5; 3.5 mL/100mL; 1/100mL 62890-001_741511de-87ca-4c22-a29b-211e3a227e50 62890-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140324 UNAPPROVED MEDICAL GAS Med-Systems, Inc. OXYGEN 99 L/100L 62891-123_b5439ef9-db5e-4223-88db-8a64d0f2e8eb 62891-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Para Pharm, Inc. dba Medical Pharmacy OXYGEN 99 L/100L 62900-4012_8fbf2be8-d7eb-4c1f-b99e-a08a0e247e72 62900-4012 HUMAN OTC DRUG Gripmax Acetaminophen, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide TABLET ORAL 20140601 OTC MONOGRAPH NOT FINAL part343 Unipharm, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 325; 10.5; 25 mg/1; mg/1; mg/1 62902-0001_00d67fd9-e51b-4fb5-8ca9-cd0609f68f60 62902-0001 HUMAN OTC DRUG Lean Love Asclepias vincetoxicum, Echinacea (Angustifolia), Hypothalamus (suis), Brain (suis), Hepar suis, Methylcobalamin, Pancreas suis, Kidney (suis), Stomach (suis), LIQUID ORAL 20140522 UNAPPROVED HOMEOPATHIC Intentional Nourishment 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; APC-356433; APC-356434; CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GLUCAGON; GRAPHITE; INSULIN HUMAN; LACTIC ACID, L-; METHYLCOBALAMIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; PORK BRAIN; PORK KIDNEY; PORK LIVER; PROTEUS VULGARIS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PANCREAS; SUS SCROFA STOMACH 30; 30; 8; 8; 6; 6; 12; 12; 30; 12; 30; 30; 8; 12; 12; 8; 8; 8; 30; 12; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 62908-011_7eebb3b0-6583-47fe-8679-e894f1740645 62908-011 HUMAN OTC DRUG NOEVIR RAYSELA ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20100101 UNAPPROVED DRUG OTHER NOEVIR USA INC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7500; 2070; 14250 mg/100g; mg/100g; mg/100g 62908-012_db90c8b8-d187-4480-be9b-95273150a11d 62908-012 HUMAN OTC DRUG NOEVIR N5 ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20100101 UNAPPROVED DRUG OTHER NOEVIR USA INC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2000; 13800; 144 mg/100g; mg/100g; mg/100g 62908-013_b919b1fd-74b9-4fee-ae43-ff87be7ed754 62908-013 HUMAN OTC DRUG NOEVIR 5 TREATMENT LIQUID FOUNDATION LX OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100801 UNAPPROVED DRUG OTHER NOEVIR USA INC OCTINOXATE; TITANIUM DIOXIDE 1000; 7490 mg/100g; mg/100g 62914-1000_fe6dce1b-2e43-4e60-971e-9b98ce646088 62914-1000 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19370101 UNAPPROVED MEDICAL GAS Medassure Inc. OXYGEN 99 L/100L 62917-350_19aede07-cd9e-4f75-9559-45cb9d65d37c 62917-350 HUMAN OTC DRUG Theraplex Eczema Therapy Moisturizing skin protectant Colloidal Oatmeal LOTION TOPICAL 20131101 OTC MONOGRAPH FINAL part347 The Theraplex Company, LLC OATMEAL 1 g/100g 62932-142_9b071443-408b-494e-b7a9-485d147b36bf 62932-142 HUMAN OTC DRUG Aunt Bees SPF 35 Cherry Lip Balm Lip Balm SPF 35 SALVE TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Private Label Select AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 10; 75; 50; 40 g/1000g; g/1000g; g/1000g; g/1000g CV 62932-143_6184ce3e-5372-4804-baff-ba6b82df2ffb 62932-143 HUMAN OTC DRUG Aunt Bees Five Flavors Pineapple Coconut Lip Balm Lip Balm SPF 35 SALVE TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Private Label Select AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 10; 75; 50; 40 g/1000g; g/1000g; g/1000g; g/1000g CI 62932-144_19ae14a9-019c-4fbf-8afc-5f7ee19fa4ba 62932-144 HUMAN OTC DRUG Aunt Bees Five Flavors Sweet Almond Lip Balm Lip Balm SPF 35 SALVE TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Private Label Select AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 10; 75; 50; 40 g/1000g; g/1000g; g/1000g; g/1000g CI 62932-145_7ed24750-2a7d-44b4-be6a-35e45b7716bb 62932-145 HUMAN OTC DRUG Aunt Bees Five Flavors Tangelo Lip Balm Lip Balm SPF 35 SALVE TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Private Label Select AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 10; 75; 50; 40 g/1000g; g/1000g; g/1000g; g/1000g CI 62932-146_6dd250c5-8d99-4727-a576-014ab62b04c0 62932-146 HUMAN OTC DRUG Aunt Bees Five Flavors Wintermint Lip Balm Lip Balm SPF 35 SALVE TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Private Label Select AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 10; 75; 50; 40 g/1000g; g/1000g; g/1000g; g/1000g CI 62935-222_24a44295-5073-434e-af06-a405a6f3ba55 62935-222 HUMAN PRESCRIPTION DRUG ELIGARD Leuprolide Acetate KIT SUBCUTANEOUS 20020123 NDA NDA021379 TOLMAR Pharmaceuticals, Inc. 62935-302_24a44295-5073-434e-af06-a405a6f3ba55 62935-302 HUMAN PRESCRIPTION DRUG ELIGARD Leuprolide Acetate KIT SUBCUTANEOUS 20020123 NDA NDA021488 TOLMAR Pharmaceuticals, Inc. 62935-452_24a44295-5073-434e-af06-a405a6f3ba55 62935-452 HUMAN PRESCRIPTION DRUG ELIGARD Leuprolide Acetate KIT SUBCUTANEOUS 20020123 NDA NDA021731 TOLMAR Pharmaceuticals, Inc. 62935-752_24a44295-5073-434e-af06-a405a6f3ba55 62935-752 HUMAN PRESCRIPTION DRUG ELIGARD Leuprolide Acetate KIT SUBCUTANEOUS 20020123 NDA NDA021343 TOLMAR Pharmaceuticals, Inc. 62936-0042_b82a8839-d9e2-40a7-8e1b-d979f260a110 62936-0042 HUMAN OTC DRUG Laura Lynn Anticavity Whitening plus Mouthwash Sodium Fluoride PASTE DENTAL 20030829 OTC MONOGRAPH FINAL part355 Ingles Market Inc SODIUM FLUORIDE 2.43 mg/g 62936-0043_5a32ad45-93cb-4624-b9da-16741c8b14f9 62936-0043 HUMAN OTC DRUG Laura Lynn Extra Whitening Sensitive Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20061206 OTC MONOGRAPH NOT FINAL part356 Ingles Market Inc POTASSIUM NITRATE; SODIUM FLUORIDE 5; 2.43 mg/g; mg/g 62956-0001_52d0b25a-43fd-4773-ac0f-20776609a8b5 62956-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000102 UNAPPROVED MEDICAL GAS Physician's Choice Medical, LLC OXYGEN 99 L/100L 62982-002_a43be534-f9e2-4cd4-84bb-bbcc5fa85860 62982-002 HUMAN OTC DRUG Effervescent Pain Relief Fast Relief Aspirin, Citric Acid Monohydrate, and Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20060922 OTC MONOGRAPH FINAL part343 Deseret Laboratories, Inc. ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 62985-5081_0182d7f1-a37e-45fe-bfad-e213d84844a7 62985-5081 HUMAN OTC DRUG First Aid Antiseptic benzalkonium chloride, benzocaine SPRAY TOPICAL 20140813 OTC MONOGRAPH NOT FINAL part333A First Aid Only BENZALKONIUM CHLORIDE; BENZOCAINE .96; 58.5 g/L; g/L 62985-5082_e680e59a-e9c9-46c8-84d9-9cbd0ada4ad2 62985-5082 HUMAN OTC DRUG Burn Lidocaine Hydrochloride SPRAY TOPICAL 20140813 OTC MONOGRAPH NOT FINAL part348 First Aid Only, Inc LIDOCAINE HYDROCHLORIDE 20 g/L 62985-5123_9a3de7d0-d34b-4145-aba9-5d3ffe54af4e 62985-5123 HUMAN OTC DRUG First Aid Only Isopropyl Alcohol Isopropyl Alcohol SPRAY TOPICAL 20141126 OTC MONOGRAPH FINAL part344 First Aid Only, Inc ISOPROPYL ALCOHOL 700 mL/L 62985-5124_8fdb24f8-d684-4b0c-a2d3-e59c5a72a21f 62985-5124 HUMAN OTC DRUG First Aid Only Hydrogen Peroxide Hydrogen Peroxide SPRAY TOPICAL 20141126 OTC MONOGRAPH NOT FINAL part333A First Aid Only, Inc HYDROGEN PEROXIDE 30 mL/L 62990-690_b76a0c0a-cd16-4ff6-b17e-9a42b11ab6f6 62990-690 HUMAN OTC DRUG Acute Care Kit Aconitum Napellus, Antimonium Tartaricum, Apis Mellifica, Arnica Montana, Arsenicum Album, Belladonna, Cantharis, Carbo Vegetabilis, Chamomilla, Cinchona, Gelsemium, Hepar Sulph Calcareum, Hypericum Perforaturm, Ipecacuanha, Kali Bichromicum, Lachesis Mutus, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla, Rhus Toxicodendron, Urtica Urens PELLET ORAL 20140421 UNAPPROVED HOMEOPATHIC MARPE LLC ACONITUM NAPELLUS; ACTIVATED CHARCOAL; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CALCIUM SULFIDE; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MATRICARIA RECUTITA; PHOSPHORUS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 62995-001_ccd547c1-be1d-4378-9725-854580fede43 62995-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19970901 UNAPPROVED MEDICAL GAS Southern ILlinois Surgical Appliance Co OXYGEN 992 mL/L 63002-001_58de352a-4b31-4fce-872c-8d5089818139 63002-001 HUMAN OTC DRUG WSNA Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140430 OTC MONOGRAPH NOT FINAL part333A Advanced Hygienics LLC BENZALKONIUM CHLORIDE 1.3 mg/mL 63002-002_863c31cc-a3b9-4bb9-b7e9-c25c253864b2 63002-002 HUMAN OTC DRUG Byotrol Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140502 OTC MONOGRAPH NOT FINAL part333A Advance Hygienics LLC BENZALKONIUM CHLORIDE 1.3 mg/mL 63004-8710_1d36c195-c433-453e-9036-d6caa58b3d52 63004-8710 HUMAN PRESCRIPTION DRUG H.P. Acthar Repository Corticotropin INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20130107 NDA NDA022432 Questcor Pharmaceuticals, Inc. CORTICOTROPIN 80 [USP'U]/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] 63005-1212_634a097f-b143-4029-9902-c64dd21dd3cc 63005-1212 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19991010 UNAPPROVED MEDICAL GAS Quality Home Oxygen, Inc OXYGEN 99 L/100L 63010-010_aae8f5e3-c52a-4cb2-b043-9130ea8294bf 63010-010 HUMAN PRESCRIPTION DRUG VIRACEPT nelfinavir mesylate TABLET, FILM COATED ORAL 19970314 NDA NDA020779 AGOURON NELFINAVIR MESYLATE 250 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 63010-011_aae8f5e3-c52a-4cb2-b043-9130ea8294bf 63010-011 HUMAN PRESCRIPTION DRUG VIRACEPT nelfinavir mesylate POWDER ORAL 19970314 NDA NDA020778 AGOURON NELFINAVIR MESYLATE 50 mg/g HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 63010-021_babb21b0-2ea1-4cb5-a232-d161254fb6d1 63010-021 HUMAN PRESCRIPTION DRUG Rescriptor delavirdine mesylate TABLET ORAL 19991103 20150831 NDA NDA020705 AGOURON DELAVIRDINE MESYLATE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] 63010-027_aae8f5e3-c52a-4cb2-b043-9130ea8294bf 63010-027 HUMAN PRESCRIPTION DRUG VIRACEPT nelfinavir mesylate TABLET, FILM COATED ORAL 20030430 NDA NDA021503 AGOURON NELFINAVIR MESYLATE 625 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] 63014-1600_d8402f8b-299a-43f7-8fc7-4477f11238d2 63014-1600 HUMAN OTC DRUG SHISEIDO REFRESHING SUN PROTECTION Avobenzone and Octinoxate SPRAY TOPICAL 20040803 OTC MONOGRAPH NOT FINAL part352 SHISEIDO INTERNATIONAL FRANCE AVOBENZONE; OCTINOXATE 3.3; 9.768 g/132g; g/132g 63020-049_33ec3564-9b94-4d70-af52-6c34a99923c7 63020-049 HUMAN PRESCRIPTION DRUG VELCADE bortezomib INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20030513 NDA NDA021602 Millennium Pharmaceuticals, Inc. BORTEZOMIB 3.5 mg/1 Proteasome Inhibitor [EPC],Proteasome Inhibitors [MoA] 63029-010_a1ba1753-d907-4172-8e06-16e7234d9d5c 63029-010 HUMAN OTC DRUG PediaCare Single Dose Fever Reducer Acetaminophen LIQUID ORAL 20130515 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN 160 mg/5mL 63029-049_76c1a847-0e19-40ad-9a85-ae53f0c5322f 63029-049 HUMAN OTC DRUG Percogesic Extra Strength Acetaminophen and Diphenhydramine CAPSULE, COATED ORAL 20100707 OTC MONOGRAPH FINAL part341 Medtech Products Inc. ACETAMINOPHEN; DIPHENHYDRAMINE 500; 12.5 mg/1; mg/1 63029-050_adcadd95-6992-4482-9904-a27d790fd42e 63029-050 HUMAN OTC DRUG Percogesic Original Strength Acetaminophen and Diphenhydramine TABLET, COATED ORAL 20100319 OTC MONOGRAPH FINAL part341 Medtech Products Inc. ACETAMINOPHEN; DIPHENHYDRAMINE 325; 12.5 mg/1; mg/1 63029-062_1af3c28a-0ba0-4036-b5c4-51a96dd9ba42 63029-062 HUMAN OTC DRUG Goodys PM Pain Reliever Acetaminophen and Aspirin and Caffeine CAPSULE, COATED ORAL 20120713 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 63029-075_a1ba1753-d907-4172-8e06-16e7234d9d5c 63029-075 HUMAN OTC DRUG PediaCare Single Dose Fever Reducer Acetaminophen LIQUID ORAL 20130515 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN 160 mg/5mL 63029-100_ba0adf41-ff2a-47ef-988e-bfd641f39373 63029-100 HUMAN OTC DRUG Little Ouchies Little Remedies Pain Relief Benzocaine and Menthol AEROSOL, SPRAY TOPICAL 20091231 OTC MONOGRAPH NOT FINAL part348 Medtech Products Inc. BENZOCAINE; MENTHOL 200; 50 mg/g; mg/g 63029-101_cbac2426-7be1-4f95-888d-a1501871f284 63029-101 HUMAN OTC DRUG Little Remedies Little Colds Mucus Relief Expectorant Melt Aways Guaifenesin GRANULE ORAL 20091231 OTC MONOGRAPH NOT FINAL part356 Medtech Products Inc. GUAIFENESIN 100 mg/1 63029-102_225493ba-a97b-42c9-968d-86923f2715dc 63029-102 HUMAN OTC DRUG Little Colds Sore Throat Relief Melt Aways Benzocaine GRANULE ORAL 20091231 OTC MONOGRAPH FINAL part356 Medtech Products Inc. BENZOCAINE 6 mg/1 63029-200_d4f30449-396e-4be2-b1c3-d10433fda3c5 63029-200 HUMAN OTC DRUG BC Cherry Aspirin and Caffeine POWDER ORAL 20121001 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ASPIRIN; CAFFEINE 845; 65 mg/1; mg/1 63029-201_07958496-ed46-446a-b827-c41cd65896d9 63029-201 HUMAN OTC DRUG BC Aspirin and Caffeine POWDER ORAL 20120601 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ASPIRIN; CAFFEINE 845; 65 mg/1; mg/1 63029-202_ce64ab5b-ac08-41b3-b4f2-943514509b96 63029-202 HUMAN OTC DRUG BC Arthritis Aspirin and Caffeine POWDER ORAL 20120601 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ASPIRIN; CAFFEINE 1000; 65 mg/1; mg/1 63029-211_525dcf76-210b-468e-b766-3a9c8d690706 63029-211 HUMAN OTC DRUG Nytol Diphenhydramine HCl TABLET ORAL 20120601 OTC MONOGRAPH FINAL part338 Medtech Products Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63029-222_9dd2e61a-21c2-4f74-8071-1702000fde1a 63029-222 HUMAN OTC DRUG Tagamet Cimetidine TABLET ORAL 20120601 NDA NDA020238 Medtech Products Inc. CIMETIDINE 200 mg/1 63029-276_482cee3b-1432-4d5a-8f53-c242e228b9f5 63029-276 HUMAN OTC DRUG Pedia Care Childrens 24 Hour Allergy Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Medtech Products Inc. CETIRIZINE HYDROCHLORIDE 5 mg/5mL 63029-301_ae512c15-44c0-4c87-8fee-1d144546e121 63029-301 HUMAN OTC DRUG Ecotrin Aspirin TABLET, COATED ORAL 20120601 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ASPIRIN 81 mg/1 63029-302_dcb96269-9bc7-4634-b67b-4732eea3a0ca 63029-302 HUMAN OTC DRUG Ecotrin Regular Strength Aspirin TABLET, COATED ORAL 20120601 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ASPIRIN 325 mg/1 63029-322_e058a340-97b4-4247-9d78-b5da29c40f47 63029-322 HUMAN OTC DRUG DEBROX Carbamide Peroxide LIQUID AURICULAR (OTIC) 20120601 OTC MONOGRAPH FINAL part344 Medtech Products Inc. CARBAMIDE PEROXIDE .065 mg/mL 63029-401_431f0c18-2834-4e91-a34c-a5a762a4c07d 63029-401 HUMAN OTC DRUG Little Noses Decongestant Nose Drops Phenylephrine Hydrochloride LIQUID NASAL 20110215 OTC MONOGRAPH FINAL part341 Medtech Products Inc. PHENYLEPHRINE HYDROCHLORIDE .00125 mg/mL 63029-402_cd299487-04ce-4c42-b402-e16cbb822df1 63029-402 HUMAN OTC DRUG Little Colds Decongestant Plus Cough Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20100901 OTC MONOGRAPH FINAL part341 Medtech Products Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/mL; mg/mL 63029-404_79db399f-84d1-4026-bb62-9a34019cb9c8 63029-404 HUMAN OTC DRUG Little Colds Multi Symptom Cold Acetaminophen and Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20100901 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 80; 2.5; 1.25 mg/mL; mg/mL; mg/mL 63029-411_70ad893b-f9d2-4f27-be9c-897fa955d3cd 63029-411 HUMAN OTC DRUG Chap-et White Petrolatum LIPSTICK TOPICAL 20120601 OTC MONOGRAPH FINAL part347 Medtech Products Inc. PETROLATUM 619.3 mg/g 63029-422_70ad893b-f9d2-4f27-be9c-897fa955d3cd 63029-422 HUMAN OTC DRUG Chap-et White Petrolatum LIPSTICK TOPICAL 20120601 OTC MONOGRAPH FINAL part347 Medtech Products Inc. PETROLATUM 619.3 mg/g 63029-424_608bd36a-358d-46a1-833b-350f17a7ecde 63029-424 HUMAN OTC DRUG Little Remedies Little Tummys Laxative Drops Sennosides LIQUID ORAL 20100601 OTC MONOGRAPH NOT FINAL part334 Medtech Products Inc. SENNOSIDES 8.8 mg/mL 63029-433_70ad893b-f9d2-4f27-be9c-897fa955d3cd 63029-433 HUMAN OTC DRUG Chap-et White Petrolatum LIPSTICK TOPICAL 20120601 OTC MONOGRAPH FINAL part347 Medtech Products Inc. PETROLATUM 619.3 mg/g 63029-435_c9e5dd36-9124-4bbf-a68e-fb50e436b9e1 63029-435 HUMAN OTC DRUG PediaCare Childrens Nighttime Multi Symptom Cold diphenhydramine, phenylephrine LIQUID ORAL 20120620 OTC MONOGRAPH FINAL part341 Medtech Products Inc DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 63029-444_70ad893b-f9d2-4f27-be9c-897fa955d3cd 63029-444 HUMAN OTC DRUG Chap-et White Petrolatum LIPSTICK TOPICAL 20120601 OTC MONOGRAPH FINAL part347 Medtech Products Inc. PETROLATUM 619.3 mg/g 63029-455_70ad893b-f9d2-4f27-be9c-897fa955d3cd 63029-455 HUMAN OTC DRUG Chap-et White Petrolatum LIPSTICK TOPICAL 20120601 OTC MONOGRAPH FINAL part347 Medtech Products Inc. PETROLATUM 619.3 mg/g 63029-500_8f069db1-017f-4965-a7ca-1cefd6c3adda 63029-500 HUMAN OTC DRUG Gly-Oxide Carbamide Peroxide LIQUID ORAL 20120601 OTC MONOGRAPH NOT FINAL part356 Medtech Products Inc. CARBAMIDE PEROXIDE .1 mg/mL 63029-501_3aaacdab-3d6f-4e39-8ae8-67258683e23d 63029-501 HUMAN OTC DRUG Stanback Aspirin and Caffeine POWDER ORAL 20120601 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ASPIRIN; CAFFEINE 845; 65 mg/1; mg/1 63029-505_d5de69ba-d61a-4aed-816a-9052672a31a1 63029-505 HUMAN OTC DRUG Sominex Max Diphenhydramine HCl TABLET ORAL 20120601 OTC MONOGRAPH FINAL part338 Medtech Products Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 63029-526_715e6272-3ab0-4621-a39f-ba053a27f0ef 63029-526 HUMAN OTC DRUG Outgro Benzocaine LIQUID TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Medtech Products Inc. BENZOCAINE .009 mg/mL 63029-550_fe2130c2-51b7-4dff-b14a-2c4b44f2fe15 63029-550 HUMAN OTC DRUG PHAZYME Simethicone CAPSULE, GELATIN COATED ORAL 20120601 OTC MONOGRAPH FINAL part332 Medtech Products Inc. DIMETHICONE 410 180 mg/1 63029-555_3cdf8796-6553-46f2-8d57-8e8dd91ce5d0 63029-555 HUMAN OTC DRUG Sominex Diphenhydramine HCl TABLET ORAL 20120601 OTC MONOGRAPH FINAL part338 Medtech Products Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63029-600_74e5ee29-b052-4971-a7ff-dcc7b2d28e69 63029-600 HUMAN OTC DRUG Goodys Back and Body Pain Acetaminophen and Asprin POWDER ORAL 20120601 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN 325; 500 mg/1; mg/1 63029-601_d74cce29-359d-4e1d-9555-83a342d86999 63029-601 HUMAN OTC DRUG Little Fevers by Little Remedies Acetaminophen LIQUID ORAL 20100705 OTC MONOGRAPH NOT FINAL part341 Medtech Products Inc. ACETAMINOPHEN .8 mL/mL 63029-602_dc78f0a8-43ef-472a-adf8-b6608ccfb316 63029-602 HUMAN OTC DRUG Little Fevers Childrens Fever Pain Reliever Acetaminophen LIQUID ORAL 20100901 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ACETAMINOPHEN 160 mg/5mL 63029-603_dc78f0a8-43ef-472a-adf8-b6608ccfb316 63029-603 HUMAN OTC DRUG Little Fevers Childrens Fever Pain Reliever Acetaminophen LIQUID ORAL 20100901 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ACETAMINOPHEN 160 mg/5mL 63029-611_6801eb4c-f713-4383-bcbe-435998bdd7f3 63029-611 HUMAN OTC DRUG Little Fevers Infant Grape Fever/Pain Reliever Acetaminophen LIQUID ORAL 20110701 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN 160 mg/5mL 63029-612_74962c65-4d94-4b8f-aee8-9d8917745998 63029-612 HUMAN OTC DRUG Goodys Migraine Relief Acetaminophen, Aspirin and Caffeine CAPSULE, COATED ORAL 20121101 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 63029-622_ed6e84da-f9ef-47d3-83cd-77d5a7c804d2 63029-622 HUMAN OTC DRUG Little Fevers Infant Berry Fever/Pain Reliever Acetaminophen LIQUID ORAL 20110701 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN 160 mg/5mL 63029-629_5a10d8a7-ab02-426c-b560-a0e69be412bd 63029-629 HUMAN OTC DRUG Goodys Headache Relief Shot Acetaminophen and Caffeine LIQUID ORAL 20130211 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ACETAMINOPHEN; CAFFEINE 1000; 65 mg/60mL; mg/60mL 63029-633_9994ad8f-a6e8-408f-9e01-a271a80ea2ac 63029-633 HUMAN OTC DRUG Goodys Extra Strength Acetaminophen, Aspirin, and Caffeine POWDER ORAL 20131101 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 260; 520; 32.5 mg/1; mg/1; mg/1 63029-639_5a10d8a7-ab02-426c-b560-a0e69be412bd 63029-639 HUMAN OTC DRUG Goodys Headache Relief Shot Acetaminophen and Caffeine LIQUID ORAL 20130211 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ACETAMINOPHEN; CAFFEINE 1000; 65 mg/60mL; mg/60mL 63029-644_9994ad8f-a6e8-408f-9e01-a271a80ea2ac 63029-644 HUMAN OTC DRUG Goodys Extra Strength Acetaminophen, Aspirin, and Caffeine POWDER ORAL 20131101 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 260; 520; 32.5 mg/1; mg/1; mg/1 63029-655_9994ad8f-a6e8-408f-9e01-a271a80ea2ac 63029-655 HUMAN OTC DRUG Goodys Extra Strength Acetaminophen, Aspirin, and Caffeine POWDER ORAL 20131101 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 260; 520; 32.5 mg/1; mg/1; mg/1 63029-661_94100c0f-ac0e-4846-9b1d-68bf701867e5 63029-661 HUMAN OTC DRUG Goodys PM Pain Reliever Acetaminophen and Diphenhydramine Citrate POWDER ORAL 20130901 OTC MONOGRAPH FINAL part341 Medtech Products Inc. ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 63029-662_9994ad8f-a6e8-408f-9e01-a271a80ea2ac 63029-662 HUMAN OTC DRUG Goodys Extra Strength Acetaminophen, Aspirin, and Caffeine POWDER ORAL 20131101 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 260; 520; 32.5 mg/1; mg/1; mg/1 63029-663_41f78bb8-0734-4f25-954c-e660e3e79d22 63029-663 HUMAN OTC DRUG Goodys Cool Orange Headache Acetaminophen and Aspirin and Caffeine POWDER ORAL 20120601 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 325; 500; 65 mg/1; mg/1; mg/1 63029-700_e7a8a83c-1453-480e-994f-837d853336db 63029-700 HUMAN OTC DRUG PediaCare Infant Fever Pain Reliever Acetaminophen LIQUID ORAL 20111015 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ACETAMINOPHEN 160 mg/5mL 63029-703_5819160b-8850-4f0d-a7b4-e17cdcd39b24 63029-703 HUMAN OTC DRUG New Skin Bandage Benzethonium Chloride LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part333A Medtech Products Inc. BENZETHONIUM CHLORIDE .06 mg/mL 63029-713_5819160b-8850-4f0d-a7b4-e17cdcd39b24 63029-713 HUMAN OTC DRUG New Skin Bandage Benzethonium Chloride SPRAY TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part333A Medtech Products Inc. BENZETHONIUM CHLORIDE 60 mg/g 63029-722_e7a8a83c-1453-480e-994f-837d853336db 63029-722 HUMAN OTC DRUG PediaCare Infant Fever Pain Reliever Acetaminophen LIQUID ORAL 20111015 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ACETAMINOPHEN 160 mg/5mL 63029-733_e7a8a83c-1453-480e-994f-837d853336db 63029-733 HUMAN OTC DRUG PediaCare Infant Fever Pain Reliever Acetaminophen LIQUID ORAL 20111015 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ACETAMINOPHEN 160 mg/5mL 63029-800_4cef7fb5-e079-43e1-b921-6526e441d901 63029-800 HUMAN OTC DRUG PediaCare Gas Relief Original Simethicone SOLUTION/ DROPS ORAL 20100901 OTC MONOGRAPH FINAL part332 Medtech Products Inc. DIMETHICONE; SILICON DIOXIDE .0211; .011 g/mL; g/mL 63029-811_d1a531a1-b770-45ee-a8c0-4c1b451f3dc8 63029-811 HUMAN OTC DRUG PediaCare Gas Relief Drops Dye Free Simethicone Emulsion and Simethicone LIQUID ORAL 20110801 OTC MONOGRAPH FINAL part332 Medtech Products Inc. DIMETHICONE; SILICON DIOXIDE .211; .011 g/mL; g/mL 63029-850_9e5bd4b1-75f3-4644-a575-abe231539be4 63029-850 HUMAN OTC DRUG Dermoplast Pain Relieving Benzocaine and Menthol SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 Medtech Products Inc. BENZOCAINE; MENTHOL 20; .5 g/1; g/1 63029-857_0b16591e-cc29-4e4f-b508-87d133c481e1 63029-857 HUMAN OTC DRUG Dermoplast Pain Relieving Antibacterial Benzethonium Chloride and Benzocaine SPRAY TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part348 Medtech Products Inc. BENZETHONIUM CHLORIDE; BENZOCAINE 20; .2 g/1; g/1 63029-900_480e61d8-6cf9-489c-9526-79d5c58318af 63029-900 HUMAN OTC DRUG PediaCare Infants Ibuprofen LIQUID ORAL 20111015 ANDA ANDA079058 Medtech Products Inc. IBUPROFEN 50 mg/1.25mL 63029-901_312cc357-0f1c-436d-946f-827e572034ab 63029-901 HUMAN OTC DRUG Dramamine Original Formula Dimenhydrinate TABLET ORAL 20120115 OTC MONOGRAPH FINAL part336 Medtech Products Inc. DIMENHYDRINATE 50 mg/1 63029-902_45add6a7-53f9-4234-bb2f-b512eac6ae8b 63029-902 HUMAN OTC DRUG Dramamine Orange Dimenhydrinate TABLET, CHEWABLE ORAL 20120115 OTC MONOGRAPH FINAL part336 Medtech Products Inc. DIMENHYDRINATE 50 mg/1 63029-903_9f11e6e6-5005-4593-a206-674b71e6b714 63029-903 HUMAN OTC DRUG Dramamine Less Drowsy Meclizine Hydrochloride TABLET ORAL 20110901 OTC MONOGRAPH FINAL part336 Medtech Products Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 63029-904_548a1cb8-cf67-45fd-855b-b7a160c6e4a4 63029-904 HUMAN OTC DRUG Dramamine for Kids Dimenhydrinate TABLET, CHEWABLE ORAL 20120215 OTC MONOGRAPH FINAL part336 Medtech Products Inc. DIMENHYDRINATE 25 mg/1 63029-911_307e5452-86d8-407c-8c2b-b1a4ba1f7bde 63029-911 HUMAN OTC DRUG PediaCare Childrens Ibuprofen SUSPENSION ORAL 20110112 ANDA ANDA074916 Medtech Products Inc. IBUPROFEN 100 mg/5mL 63032-101_615a8930-7a86-4f16-b7ac-6465c1fdb51b 63032-101 HUMAN PRESCRIPTION DRUG OLUX-E clobetasol propionate AEROSOL, FOAM TOPICAL 20070212 20150228 NDA NDA022013 Stiefel Laboratories Inc CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63039-1002_4c8935f0-6690-46ff-9843-02af2674274e 63039-1002 HUMAN OTC DRUG E-2 Food Processing Foam Hand Wash BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140331 OTC MONOGRAPH NOT FINAL part333A Chemco Products Company BENZALKONIUM CHLORIDE 1.3 mg/mL 63039-1005_4d31a83b-0fea-4782-9e7b-ed75920243eb 63039-1005 HUMAN OTC DRUG Antibacterial Foam Hand Wash CHLOROXYLENOL LIQUID TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part333A Chemco Products Company CHLOROXYLENOL 2.5 mg/mL 63041-110_91afd078-c606-4aed-b7ea-73eeed69efef 63041-110 HUMAN OTC DRUG IMADA FOUR SEASONS SAFE ANALGESIC BALM Menthol OIL TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part348 LUEN WAH HK MEDICINE LTD MENTHOL 16 g/100mL 63041-130_282a7784-36f6-44bd-8c9a-c7edfd08eae2 63041-130 HUMAN OTC DRUG IMADA RED FLOWER ANALGESIC Methyl Salicylate OIL TOPICAL 20140125 OTC MONOGRAPH NOT FINAL part348 LUEN WAH HK MEDICINE LTD METHYL SALICYLATE 60 g/100mL 63043-0001_89621a83-6263-4276-953b-99f9bfb221d2 63043-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19961201 UNAPPROVED MEDICAL GAS Home Respiratory Therapy and Equipment, Inc. OXYGEN 99 L/100L 63044-030_8faec0ee-57ae-4e12-81d9-86f6728133dc 63044-030 HUMAN OTC DRUG ZIKS ARTHRITIS PAIN RELIEF ZIKS ARTHRITIS PAIN RELIEF CREAM TOPICAL 19991110 OTC MONOGRAPH FINAL part334 Nnodum Pharmaceuticals CAPSAICIN; MENTHOL; METHYL SALICYLATE .014; .566; 6.79 mg/g; mg/g; mg/g 63044-153_f48327a6-8aa3-41b4-bfa5-a1665174e5ef 63044-153 HUMAN PRESCRIPTION DRUG INATAL ADVANCE INATAL ADVANCE TABLET, COATED ORAL 20050610 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; DOCUSATE SODIUM; FOLIC ACID; IRON PENTACARBONYL; MAGNESIUM OXIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; ZINC OXIDE 30; 120; 200; 400; 2; 12; 50; 1; 90; 30; 20; 20; 3.4; 3; 2700; 25 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 63044-154_4b22195d-d683-4ced-ae90-2aa395765bf8 63044-154 HUMAN PRESCRIPTION DRUG INATAL Ultra INATAL Ultra TABLET, COATED ORAL 20050620 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM CITRATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; DOCUSATE SODIUM; FOLIC ACID; IRON PENTACARBONYL; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; ZINC OXIDE 30; 120; 200; 400; 2; 12; 50; 1; 90; 20; 150; 20; 3.4; 3; 2700; 25 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 63044-198_9f3bf415-c0c0-4a81-ad9b-7fffc9202832 63044-198 HUMAN OTC DRUG Iferex 150 Forte Iron, Cyanocobalamin and Folic Acid CAPSULE ORAL 20071028 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals CYANOCOBALAMIN; FOLIC ACID; IRON 25; 1; 150 mg/1; mg/1; mg/1 63044-203_53257303-5bbb-49f4-ba91-f3ea6c88a883 63044-203 HUMAN OTC DRUG IFEREX 150 Polysaccharide-Iron Complex CAPSULE ORAL 20071028 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals IRON 150 mg/1 63044-401_4c504dd6-9e4a-42c3-9fee-26d63c5c9e34 63044-401 HUMAN OTC DRUG Vitamin D3Dietary Supplemen Dietary Supplement CHOLECALCIFEROL CAPSULE, GELATIN COATED ORAL 20120114 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals .ALPHA.-TOCOPHEROL; CHOLECALCIFEROL 5; .25 [iU]/1; mg/1 63044-404_e730958b-9e8f-43b8-bcb2-ccddab3d9448 63044-404 HUMAN OTC DRUG Ammonium Lactate Ammonium Lactate CREAM TOPICAL 20071230 OTC MONOGRAPH NOT FINAL part334 Nnodum Pharmaceuticals AMMONIUM LACTATE 17 g/g 63044-484_cba000ad-31e5-43a5-a992-8ae86298ad6d 63044-484 HUMAN OTC DRUG Ammonium Lactate Ammonium Lactate LOTION TOPICAL 20071230 OTC MONOGRAPH NOT FINAL part334 Nnodum Pharmaceuticals AMMONIUM LACTATE 17 g/g 63044-622_71d7f6ee-3907-4214-8758-0f374526b6be 63044-622 HUMAN PRESCRIPTION DRUG RENO CAPS RENO CAPS CAPSULE ORAL 20081130 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; THIAMINE 100; 150; 6; 1; 20; 5; 10; 1.7; 1.5 mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 63044-631_7b22f471-94b6-42de-aa6f-35e441c00f57 63044-631 HUMAN PRESCRIPTION DRUG HEMATOGEN FERROUS FUMARATE, ASCORBIC ACID, INTRINSIC FACTOR , CYANOCOBALAMIN CAPSULE ORAL 20070510 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals ASCORBIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE; INTRINSIC FACTOR 250; 10; 66; 100 mg/1; ug/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 63044-632_04d6e28a-1731-43fa-8d8a-192943c8e007 63044-632 HUMAN PRESCRIPTION DRUG Hematogen FA FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN CAPSULE ORAL 20050101 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals ASCORBIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID 250; 10; 66; 1 mg/1; ug/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 63044-633_331ef233-b9e5-4539-b4f6-34b8084c34c4 63044-633 HUMAN PRESCRIPTION DRUG HEMATOGEN FORTE FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN CAPSULE, GELATIN COATED ORAL 20070510 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals ASCORBIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID 1; 10; 151; 10 mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 63044-635_772d1dd3-a18c-4289-af06-ff0e144fab09 63044-635 HUMAN PRESCRIPTION DRUG TRICON TRICON CAPSULE ORAL 20050520 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals ASCORBIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID 75; 15; 110; .5 mg/1; ug/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 63045-001_81ac4b66-e47c-4a66-843f-d42d0b27803f 63045-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060516 NDA NDA205827 Wyandotte Welding Supply Inc. OXYGEN 990 mL/L 63049-101_304e5c5f-a1c0-4f8b-ba67-11160b109343 63049-101 HUMAN OTC DRUG EAD Avobenzone,Homosalate,Octisalate,Octocrylene LOTION TOPICAL 20140318 OTC MONOGRAPH FINAL part352 European Perfume Works Co.L.L.C. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.44; 2.4; 6; 1.2 g/120mL; g/120mL; g/120mL; g/120mL 63049-102_d1bbd0c3-cd80-42a2-bdb6-867b94ed8867 63049-102 HUMAN OTC DRUG EAD Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20140318 OTC MONOGRAPH FINAL part352 European Perfume Works Co.L.L.C AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.4; 7.2; 6; 2.4; 2.4 g/120mL; g/120mL; g/120mL; g/120mL; g/120mL 63049-103_dc1e70f2-6f3e-46bb-bc32-8f96b1c98147 63049-103 HUMAN OTC DRUG EAD Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20140318 OTC MONOGRAPH FINAL part352 European Perfume Works Co. L.L.C AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.4; 14.4; 6; 2.4; 2.4 g/120mL; g/120mL; g/120mL; g/120mL; g/120mL 63054-0123_297624b2-c1db-47bf-bf2a-584e65577298 63054-0123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19950617 UNAPPROVED MEDICAL GAS Alert Respiratory Services, Inc. OXYGEN 99 L/100L 63057-0001_dab96a89-d313-43d5-b1cc-8e454316e292 63057-0001 HUMAN OTC DRUG Texas Knows Allegy Relief Allium Cepa, Ambrosia Artemisiaefolia, Aralia Racemosa, Cineraria Maritima, Histaminum Hydrochloricum, Luffa Operculata, Naphthalinum, populus Candicans, Quercus Glandium Spiritus LIQUID ORAL 20140709 UNAPPROVED HOMEOPATHIC Oak Hill Health Company AMBROSIA ARTEMISIIFOLIA; ANTHOXANTHUM ODORATUM; ARALIA RACEMOSA ROOT; CANDIDA ALBICANS; HISTAMINE DIHYDROCHLORIDE; JACOBAEA MARITIMA; LUFFA OPERCULATA FRUIT; NAPHTHALENE; ONION; POPULUS BALSAMIFERA LEAF BUD; QUERCUS ROBUR NUT; SALIX NIGRA BARK; SAMBUCUS NIGRA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; ULMUS PROCERA FLOWERING TWIG; URTICA URENS 10; 15; 10; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 63058-001_dfdec016-4cae-4a86-9eb3-511d3e0c5de7 63058-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Scott Valley Respiratory Home Care Inc. OXYGEN 99 L/100L 63076-0001_553b5800-858a-4c05-a5f1-dc88870b7fdd 63076-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19930703 UNAPPROVED MEDICAL GAS American Homecare Specialists, Inc. OXYGEN 99 L/100L 63080-679_b32e2cc7-d93b-458f-9a30-189599d0b19e 63080-679 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19950101 UNAPPROVED MEDICAL GAS Galloping Hill Surgical Corp. dba Allcare Medical OXYGEN 99.8 L/100L 63094-0426_11ddf219-8537-4a8f-b267-ef965159885e 63094-0426 HUMAN OTC DRUG TIOCONAZOLE Ointment 6.5% TIOCONAZOLE OINTMENT VAGINAL 20070822 ANDA ANDA075915 DPT Laboratories, Ltd. TIOCONAZOLE 65 mg/g 63094-0801_3637ca89-694d-4061-a23d-e691093276e7 63094-0801 HUMAN OTC DRUG Scytera (coal tar) Foam, 2% coal tar foam, 2% AEROSOL, FOAM TOPICAL 20081031 OTC MONOGRAPH FINAL part358 DPT Laboratories, Ltd. COAL TAR 20 mg/g 63102-101_4f9c4e91-b529-45f1-8439-293d87f6a736 63102-101 HUMAN OTC DRUG ACTINEL Dextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl SOLUTION ORAL 20140924 OTC MONOGRAPH FINAL part341 ACTIPHARMA, INC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 15; 200; 30 mg/5mL; mg/5mL; mg/5mL 63102-102_fbbd0fc0-7a67-48f5-a822-21db3172ef4c 63102-102 HUMAN OTC DRUG ACTINEL PEDIATRIC Dextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl SOLUTION ORAL 20140924 OTC MONOGRAPH FINAL part341 ACTIPHARMA, INC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 50; 15 mg/5mL; mg/5mL; mg/5mL 63104-001_2356095f-b006-411f-8de0-7d4c867368c2 63104-001 HUMAN OTC DRUG Bentasil SUGAR FREE BLACKCURRANT SOFT Texture Menthol LOZENGE ORAL 20140401 OTC MONOGRAPH FINAL part341 CLOETTA ITALIA S.r.l. MENTHOL 5 mg/1 63104-002_442be69f-b49e-4445-9bb7-20f91b9a8b3d 63104-002 HUMAN OTC DRUG Bentasil SUGAR FREE CHERRY SOFT Texture Menthol LOZENGE ORAL 20140401 OTC MONOGRAPH FINAL part341 CLOETTA ITALIA S.r.l. MENTHOL 5 mg/1 63104-003_5069cb14-68e1-4acc-8015-b3f12ad448ef 63104-003 HUMAN OTC DRUG Bentasil SUGAR FREE EUCALYPTUS SOFT Texture Menthol Eucalyptus LOZENGE ORAL 20140401 OTC MONOGRAPH FINAL part341 CLOETTA ITALIA S.r.l. EUCALYPTUS OIL; MENTHOL 5.7; 5.8 mg/1; mg/1 63104-004_bb51f005-43c0-49f4-9217-7c1011c442a4 63104-004 HUMAN OTC DRUG Bentasil SUGAR FREE HONEY LEMON SOFT Texture Menthol LOZENGE ORAL 20140401 OTC MONOGRAPH FINAL part341 CLOETTA ITALIA S.r.l. MENTHOL 5 mg/1 63121-123_3cc0f897-5eb2-4f8c-95bd-127c7c6021c6 63121-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19960801 UNAPPROVED MEDICAL GAS First Community Care of Bassett OXYGEN 99 L/100L 63138-120_63b16db9-fcfb-4d2b-a9c4-cf3dae88b14b 63138-120 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19960926 UNAPPROVED MEDICAL GAS Parkmor Drug Inc. OXYGEN 99 L/100L 63139-001_fdf0f8c7-dcf0-4055-85e4-9d58769bba92 63139-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS All American Welding Supply Inc OXYGEN 990 mL/L 63146-101_01be293b-5b28-45c4-bf4b-4d30a1e6e1c5 63146-101 HUMAN OTC DRUG Conquest Chloroxylenol SOLUTION TOPICAL 20051013 OTC MONOGRAPH NOT FINAL part333E KAY CHEMICAL CO. CHLOROXYLENOL .5 mL/100mL 63146-102_fbfeb47b-002d-411b-962d-2e9e4fabd44e 63146-102 HUMAN OTC DRUG McD Anti-Microbial Handwash (AMH) Chloroxylenol SOLUTION TOPICAL 20051013 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company CHLOROXYLENOL .5 mL/100mL 63146-103_a7bfd919-bcf7-4956-9ad0-9919e5145bf4 63146-103 HUMAN OTC DRUG DermaFoam E Antibacterial Hand Soap Antiseptic handwash SOLUTION TOPICAL 20051013 OTC MONOGRAPH NOT FINAL part333 Kay Chemical CHLOROXYLENOL 1 mL/100mL 63146-104_02fa58e7-d5a4-469b-a04e-a83731bf8016 63146-104 HUMAN OTC DRUG Marquis chloroxylenol SOLUTION TOPICAL 20051113 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Co. CHLOROXYLENOL .5 mL/100mL 63146-105_33c94b9d-020e-4230-8526-b1461bcc5f44 63146-105 HUMAN OTC DRUG Fortress Chloroxylenol SOLUTION TOPICAL 20050516 OTC MONOGRAPH NOT FINAL part333E Kay Chemcial Co. CHLOROXYLENOL .5 mL/100mL 63146-107_06e5ace8-9ac3-426d-bfbe-57ab530a901a 63146-107 HUMAN OTC DRUG Lagarde chloroxylenol SOLUTION TOPICAL 20051013 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Co. CHLOROXYLENOL .5 mL/100mL 63146-108_46a1497e-08c9-443b-a017-885b0f0880be 63146-108 HUMAN OTC DRUG McD Chloroxylenol SOLUTION TOPICAL 20070817 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Co. CHLOROXYLENOL .5 mL/100mL 63146-109_fe16dfd7-5d42-44c9-9314-157c82672e3f 63146-109 HUMAN OTC DRUG Kay Foaming Hand Sanitizer Benzalkonium Chloride SOLUTION TOPICAL 20080222 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company BENZALKONIUM CHLORIDE .1 mL/100mL 63146-110_abef516e-6f59-479a-8ec9-ea899985b090 63146-110 HUMAN OTC DRUG QSR Antibacterial Hand Soap Antiseptic handwash SOLUTION TOPICAL 20091215 OTC MONOGRAPH NOT FINAL part333 Kay Chemical Company CHLOROXYLENOL .5 mL/100mL 63146-111_450781b4-c6aa-4fac-a477-92761caa6c1d 63146-111 HUMAN OTC DRUG QSR Foaming Antibacterial Hand Soap Antiseptic handwash SOLUTION TOPICAL 20100222 OTC MONOGRAPH NOT FINAL part333 Kay Chemical Company CHLOROXYLENOL .5 mL/100mL 63146-112_616f8e6d-db92-4ff5-a2c4-4634e74a12e6 63146-112 HUMAN OTC DRUG QSR Hand Sanitizer Alcohol SOLUTION TOPICAL 20100223 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company ALCOHOL 534 mg/mL 63146-116_e98649f6-928f-40d4-b118-69a2cc171e1f 63146-116 HUMAN OTC DRUG Mystic Triclosan SOLUTION TOPICAL 20101122 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company TRICLOSAN .3 mL/100mL 63146-117_d85bc2f1-68aa-4d72-a597-0465dd684b09 63146-117 HUMAN OTC DRUG Mystic Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company BENZALKONIUM CHLORIDE .1 mL/100mL 63146-118_5243e6c2-506c-4f1c-b5cd-4446fa7db0bb 63146-118 HUMAN OTC DRUG Kay QSR Triclosan SOLUTION TOPICAL 20110830 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Co. TRICLOSAN .3 mL/100mL 63146-201_62539921-c022-40aa-9756-983b84a1e915 63146-201 HUMAN OTC DRUG Conquest II chloroxylenol SOLUTION TOPICAL 20051013 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Co CHLOROXYLENOL .5 mL/100mL 63146-301_6b82b899-44dc-4cd9-9c5b-a4a0ea7ba2f1 63146-301 HUMAN OTC DRUG Actigel Hand Sanitizer Alcohol SOLUTION TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company ALCOHOL 534 mg/mL 63146-302_edc26609-6078-4e47-8c80-52e73baea651 63146-302 HUMAN OTC DRUG McD Hand Sanitizer Ethanol, 60% by volume SOLUTION TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333 Kay Chemical Company ETHANOL 60 mL/100mL 63146-303_3cec165b-a6d3-4a1c-ba63-f4768c4feb4e 63146-303 HUMAN OTC DRUG Kay Alphasan Hand Sanitizer Alcohol SOLUTION TOPICAL 20051013 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Co ALCOHOL 60 mL/100mL 63148-118_d3e90fc2-15ab-4d26-b51f-58eaa9a5faa7 63148-118 HUMAN OTC DRUG PRICE CHOPPER PUMPKIN SPICE ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE TRICLOSAN 4.6 mg/mL 63148-140_8d28c156-5e49-4d3f-959c-e6e8640da049 63148-140 HUMAN OTC DRUG ANTIBACTERIAL HAND SOAP WITH LIGHT MOISTURIZERS TRICLOSAN LOTION TOPICAL 20100224 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE TRICLOSAN .115 mL/100mL 63148-141_00009b19-6d96-435d-8dc2-13432b12ee9e 63148-141 HUMAN OTC DRUG ANTIBACTERIAL HAND SOAP WITH LIGHT MOISTURIZERS TRICLOSAN LOTION TOPICAL 20100224 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE TRICLOSAN .115 mL/100mL 63148-164_981ecab8-cd2c-4d72-90e0-d9d8bf60c819 63148-164 HUMAN OTC DRUG ANTIBACTERIAL FOAMING POMEGRANATE TRICLOSAN LIQUID TOPICAL 20100706 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care TRICLOSAN .46 mL/100mL 63148-165_bf09bb77-1853-4b0e-a3d2-c4f0162f1b32 63148-165 HUMAN OTC DRUG CARE ONE Antibacterial Foaming Hand Soap Green Tea Triclosan LIQUID TOPICAL 20090717 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care TRICLOSAN .46 mL/100mL 63148-167_c2ac7051-2f25-414a-a367-54fe55ce541f 63148-167 HUMAN OTC DRUG Foaming Antibacterial Cucumber Melon Triclosan LIQUID TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care TRICLOSAN .6 mL/100mL 63148-173_f865e380-74bc-4e4f-a4a0-c1d749796b87 63148-173 HUMAN OTC DRUG FOAMING ANTIBACTERIAL PLUMERIA TRICLOSAN SOAP TOPICAL 20100720 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE TRICLOSAN .6 mL/100mL 63148-215_0d880a28-6433-43cf-81d9-12f12ca88be1 63148-215 HUMAN OTC DRUG Antibacterial Mandarin and Grapefruit Handsoap Gentle Cleansing Formula TRICLOSAN LIQUID TOPICAL 20100628 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care TRICLOSAN .15 mL/100mL 63148-225_7fee5284-8e16-4511-8e94-daf556137e7f 63148-225 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20100705 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL 63148-225_8c1aea5c-a193-4abc-a50b-4fda78d92818 63148-225 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL 63148-240_b035432f-f0d7-42d5-b132-2e4fb2674032 63148-240 HUMAN OTC DRUG FOAMING HAND SANITIZER WITH ALOE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100625 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE BENZALKONIUM CHLORIDE .1 mL/100mL 63148-241_54677fac-cf5e-4cdd-a77c-5780a69ba972 63148-241 HUMAN OTC DRUG ANTIMICROBIAL FOAMING FALLING RAIN BENZETHONIUM CHLORIDE LIQUID TOPICAL 20110722 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE BENZETHONIUM CHLORIDE .1 mL/100mL 63148-250_00a86e8f-dc4e-4125-bf56-bd361c424899 63148-250 HUMAN OTC DRUG CVS PHARMACY INSTANT HAND SANITIZER FRESH SCENT ETHYL ALCOHOL GEL TOPICAL 20091010 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care ALCOHOL 62 mL/100mL 63148-251_3ff94d36-7237-448f-bb7b-5d8d4a39b013 63148-251 HUMAN OTC DRUG CVS PHARMACY ANTI-AGING HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20091020 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care ALCOHOL 62 mL/100mL 63148-252_51834035-0a13-4d92-a608-43b7d23a44b3 63148-252 HUMAN OTC DRUG CVS Pharmacy FOAM HAND SANITIZER WITH ALOE ETHYL ALCOHOL LIQUID TOPICAL 20091217 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care ALCOHOL 70 mL/100mL 63148-253_677a3bd4-f63f-467b-9de2-e08900b8e987 63148-253 HUMAN OTC DRUG CVS PHARMACY INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20091010 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care ALCOHOL 65 mL/100mL 63148-258_4cfcba2a-a6bc-4e1b-a546-3c7853f15f21 63148-258 HUMAN OTC DRUG HAND SANITIZER CITRUS COCONUT with moisture beads ETHYL ALCOHOL GEL TOPICAL 20100215 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL 63148-259_7882c344-2b45-46de-af0e-f828f29b6ac2 63148-259 HUMAN OTC DRUG HAND SANITIZER PASSION FLOWER with moisture beads ETHYL ALCOHOL GEL TOPICAL 20100215 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL 63148-261_a524f129-150a-483c-8e18-00ea1aca338b 63148-261 HUMAN OTC DRUG HAND SANITIZER SUN BLOSSOM with moisture beads ETHYL ALCOHOL GEL TOPICAL 20100215 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL 63148-262_540a79ad-8727-4721-8045-5f900054702b 63148-262 HUMAN OTC DRUG HAND SANITIZER POMEGRANATE APPLE with moisture beads ETHYL ALCOHOL GEL TOPICAL 20100215 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL 63148-269_3df5a074-1fdc-4b7a-af72-35b7bcd7f131 63148-269 HUMAN OTC DRUG ANTIBACTERIAL HAND SANITIZER BASIL AND GREEN TEA ETHYL ALCOHOL GEL TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL 63148-270_50f99008-5d7c-4bbb-a500-223b23363e81 63148-270 HUMAN OTC DRUG ANTIBACTERIAL HAND SANITIZER SUNFLOWER AND CITRUS ETHYL ALCOHOL GEL TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL 63148-271_4280f663-da2f-4cbb-91bb-7b29718d61e7 63148-271 HUMAN OTC DRUG ANTIBACTERIAL HAND SANITIZER POMEGRANATE AND ACAI ETHYL ALCOHOL GEL TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL 63148-320_ee252b4a-8893-40eb-98c2-5050a432cdd9 63148-320 HUMAN OTC DRUG SKIN MOISTURIZING WITH NATURAL COLLOIDAL OATMEAL DIMETHICONE LOTION TOPICAL 20100625 OTC MONOGRAPH FINAL part347 APOLLO HEALTH AND BEAUTY CARE DIMETHICONE 1.25 mL/100mL 63148-330_5ff46716-6084-416e-9026-e4cc90a879ae 63148-330 HUMAN OTC DRUG HYDRATING HEALING DAILY THRAPY PETROLATUM OINTMENT TOPICAL 20100719 OTC MONOGRAPH FINAL part347 APOLLO HEALTH AND BEAUTY CARE PETROLATUM 41 g/100g 63148-418_b94730e1-3d0f-4bea-a4ba-a8c290bb5695 63148-418 HUMAN OTC DRUG DANDRUFF SHAMPOO AND CONDITIONER WITH CUCUMBER AND LEMONGRASS EXTRACTS PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20100308 OTC MONOGRAPH FINAL part358 APOLLO HEALTH AND BEAUTY CARE PYRITHIONE ZINC 1 mL/100mL 63148-422_88c771f3-12c7-4877-8ed8-f4961bb10252 63148-422 HUMAN OTC DRUG ANTI-DANDRUFF SHAMPOO AND CONDITIONER HOWL PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20100308 OTC MONOGRAPH FINAL part358 Apollo Health and Beauty Care PYRITHIONE ZINC 1 mL/100mL 63148-450_f396572c-fab5-4b35-8ad1-25f009d8c436 63148-450 HUMAN OTC DRUG NUTRIXYL ANTI-DANDRUFF SALICYLIC ACID LIQUID TOPICAL 20140918 OTC MONOGRAPH FINAL part358H APOLLO HEALTH AND BEAUTY CARE SALICYLIC ACID 20 mg/mL 63148-556_178eb802-d15c-4886-9113-b83e55176dc0 63148-556 HUMAN OTC DRUG MARCS ORIGINAL EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140213 OTC MONOGRAPH NOT FINAL part356 APOLLO HEALTH AND BEAUTY CARE EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 63148-557_cab8004b-b0eb-4d57-adcc-b3edf5fae46c 63148-557 HUMAN OTC DRUG MARCS BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140213 OTC MONOGRAPH NOT FINAL part356 APOLLO HEALTH AND BEAUTY CARE EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 63148-558_350b0901-4a78-46fb-a11c-a11321773616 63148-558 HUMAN OTC DRUG MARCS SPRING MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140213 OTC MONOGRAPH NOT FINAL part356 APOLLO HEALTH AND BEAUTY CARE EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 63148-801_c0f5a6ac-3714-4da1-9610-5cb77832b473 63148-801 HUMAN OTC DRUG Natural Concept Body Wash Spring Breeze Triclosan SOAP TOPICAL 20100922 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care TRICLOSAN .15 mL/100mL 63148-804_22066d6b-8e5c-4a38-a5a5-4ce84ef7a9fb 63148-804 HUMAN OTC DRUG SPARKLING MIST ANTIBACTERIAL CLEANSER WITH MOISTURIZERS TRICLOSAN LOTION TOPICAL 20100715 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care TRICLOSAN .15 mL/100mL 63162-508_34f2008d-8ed5-4ef7-8c03-c8fd56d77d93 63162-508 HUMAN OTC DRUG Balamine DM Syrup Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide LIQUID ORAL 20130423 OTC MONOGRAPH FINAL part341 Ballay Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/5mL; mg/5mL; mg/5mL 63162-510_8742a375-a463-41bf-b9d7-1fc303dcd62f 63162-510 HUMAN OTC DRUG Childrens Nortemp Acetaminophen SOLUTION ORAL 20140326 OTC MONOGRAPH NOT FINAL part343 Ballay Pharmaceuticals, Inc ACETAMINOPHEN 160 mg/5mL 63162-518_fb610708-d80d-4598-a524-0e8f444d1696 63162-518 HUMAN OTC DRUG Nortemp Acetaminophen SOLUTION/ DROPS ORAL 19970401 OTC MONOGRAPH NOT FINAL part343 Ballay Pharmaceuticals, Inc ACETAMINOPHEN 80 mg/.8mL 63162-520_da947d56-e0f5-4f91-88bd-82990cd4a7c4 63162-520 HUMAN OTC DRUG Balahist DM Syrup Brompheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide LIQUID ORAL 20140106 OTC MONOGRAPH FINAL part341 Ballay Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 15; 7.5 mg/5mL; mg/5mL; mg/5mL 63174-172_0f34f883-7781-46ff-aa86-842bf5cf1837 63174-172 HUMAN OTC DRUG Morning Fresh Sodium Monofluorophosphate PASTE ORAL 20130405 OTC MONOGRAPH FINAL part355 Choice Laboratories Limited SODIUM MONOFLUOROPHOSPHATE 1 mg/g 63174-214_792dae09-40ca-41e8-acf5-f4898b94738a 63174-214 HUMAN OTC DRUG Choice Vitamin A D Petrolatum OINTMENT TOPICAL 20130719 OTC MONOGRAPH FINAL part347 Choice Laboratories Limited PETROLATUM .76 g/g 63174-224_d268b744-00fa-42e1-9275-ee17990c70f6 63174-224 HUMAN OTC DRUG Hydrocortisone Hydrocortisone Acetate CREAM TOPICAL 20100202 OTC MONOGRAPH FINAL part348 Choice Laboratories HYDROCORTISONE ACETATE 1 g/100g 63181-0010_1217d971-3111-46cc-a693-3a80bb531991 63181-0010 HUMAN OTC DRUG REPASKIN FACIAL, BROAD SPECTRUM SPF 30 OCTOCRYLENE, PHENYLBENZIMIDAZOLE SULFONIC ACID CREAM TOPICAL 20140404 OTC MONOGRAPH NOT FINAL part352 Sesvalia USA LLC ENSULIZOLE; OCTOCRYLENE 20; 50 mg/mL; mg/mL 63181-0011_aeba5ccb-fcb7-4c8a-a84f-ce5597754d3f 63181-0011 HUMAN OTC DRUG REPASKIN FACIAL, BROAD SPECTRUM SPF 50 OCTOCRYLENE, TITANIUM DIOXIDE CREAM TOPICAL 20140404 OTC MONOGRAPH NOT FINAL part352 Sesvalia USA LLC OCTOCRYLENE; TITANIUM DIOXIDE 70; 20 mg/mL; mg/mL 63181-0012_b14d0e46-6884-42ab-92fe-a3b0dd16014f 63181-0012 HUMAN OTC DRUG REPASKIN BODY LOTION, BROAD SPECTRUM SPF 30 OCTOCRYLENE, PHENYLBENZIMIDAZOLE SULFONIC ACID CREAM TOPICAL 20140404 OTC MONOGRAPH NOT FINAL part352 Sesvalia USA LLC ENSULIZOLE; OCTOCRYLENE 20; 50 mg/mL; mg/mL 63181-0013_f66727c6-163c-4dac-9157-c3181f852b45 63181-0013 HUMAN OTC DRUG REPASKIN BODY LOTION, BROAD SPECTRUM SPF 50 OCTOCRYLENE, TITANIUM DIOXIDE CREAM TOPICAL 20140404 OTC MONOGRAPH NOT FINAL part352 Sesvalia USA LLC OCTOCRYLENE; TITANIUM DIOXIDE 70; 20 mg/mL; mg/mL 63181-0014_c3a22d4f-eafa-4411-812d-85fa016a273d 63181-0014 HUMAN OTC DRUG Sesderma SESPREVEX Calming and protecting foam ZINC OXIDE AEROSOL, FOAM TOPICAL 20140407 OTC MONOGRAPH FINAL part347 Sesvalia USA LLC ZINC OXIDE 140 mg/mL 63181-0015_a4a11e27-e109-4d6b-85a4-a3ebcca6e62e 63181-0015 HUMAN OTC DRUG Dryses Antiperspirant Solution ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20140402 OTC MONOGRAPH FINAL part350 SESVALIA USA LLC. ALUMINUM CHLOROHYDRATE 200 mg/mL 63181-0016_352dee35-c03d-4fa7-b113-4a1f7ea89dd5 63181-0016 HUMAN OTC DRUG SALISES FACIAL Moisturizing acne treatment gel SALICYLIC ACID GEL TOPICAL 20140404 OTC MONOGRAPH FINAL part333D Sesvalia USA LLC SALICYLIC ACID 15 mg/mL 63181-0017_23e315ae-a937-46bf-87bc-d0d212529399 63181-0017 HUMAN OTC DRUG SCREENSES Tinted facial make-up cream zinc oxide and octinoxate sunscreen CREAM TOPICAL 20140407 OTC MONOGRAPH FINAL part352 Sesvalia USA LLC OCTINOXATE; ZINC OXIDE 75; 90 mg/mL; mg/mL 63181-0018_d43e8896-4e6f-4391-98a5-1053e50d3eb5 63181-0018 HUMAN OTC DRUG LIDOCARE MIST Lidocaine SPRAY TOPICAL 20140404 OTC MONOGRAPH NOT FINAL part348 Sesvalia USA LLC LIDOCAINE 20 mg/mL 63181-0019_5d9a60a4-f6c4-4d1e-b8b3-6f74faabd39e 63181-0019 HUMAN OTC DRUG Dryses Deoderant for men, Roll-on ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20140407 OTC MONOGRAPH FINAL part350 SESVALIA USA LLC. ALUMINUM CHLOROHYDRATE 180 mg/mL 63187-002_bf2b41aa-8bac-4de7-98b2-884cbcee6c6c 63187-002 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA078050 Proficient Rx ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63187-003_110b351c-fd13-408a-bf08-e47c1fcd8c93 63187-003 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Proficient Rx LEVOFLOXACIN 500 mg/1 63187-004_110b351c-fd13-408a-bf08-e47c1fcd8c93 63187-004 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Proficient Rx LEVOFLOXACIN 750 mg/1 63187-005_940c4ba6-80f4-4c9c-831d-1d166ef9a3fe 63187-005 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20080131 NDA NDA020987 Proficient Rx PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 63187-006_69c094f4-1ffe-4d36-8143-34f4bed175c6 63187-006 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20040214 ANDA ANDA075694 Proficient Rx GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63187-007_a6c8c7c3-2449-44f2-9f3b-597cb5c3a2cb 63187-007 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065225 Proficient Rx LP AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 63187-008_6eb12b74-b0fa-4a5d-9a8b-07f9515731ed 63187-008 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20060822 ANDA ANDA076817 Proficient Rx LP SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 63187-009_c2353d09-3cb4-486e-8ae7-29339c1ba76b 63187-009 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Proficient Rx LP TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 63187-010_c78f528f-9192-4037-bfb9-ff5718ed26c5 63187-010 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Proficient Rx LP GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63187-011_46100534-edd7-408e-879a-bab1c8fd9e3e 63187-011 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19890503 ANDA ANDA071611 Proficient Rx LP CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63187-012_79fa6b82-957a-416f-a2e0-6f0aa8579044 63187-012 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Proficient Rx LP DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63187-013_5d080267-a1ad-4714-8fcd-ca291fbd1ef4 63187-013 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin TABLET, FILM COATED ORAL 19780710 NDA NDA050754 Proficient Rx LP AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63187-014_1e91c5ce-3482-47ca-92e7-e492196992d9 63187-014 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091568 Proficient Rx LP AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 63187-016_bc912150-09fa-48ea-8dab-ecec9353e74c 63187-016 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Proficient Rx LP BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 63187-017_2822a7b4-3b56-41ff-8992-2a6dd268907c 63187-017 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Proficient Rx LP CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 63187-018_5b9c497c-5e32-4c77-82ab-fe6abdd9cf57 63187-018 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101 ANDA ANDA073517 Proficient Rx LP KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63187-019_96961faa-3009-49e4-bfb7-498bcc589aec 63187-019 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 Proficient Rx LP METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63187-020_7c650dc8-43f6-4257-81ed-c93b00202d06 63187-020 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 Proficient Rx LP PREDNISONE 5 mg/1 63187-021_a37ccef8-18e8-4194-9618-1b5657ade6ca 63187-021 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20080116 ANDA ANDA077570 Proficient Rx LP FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63187-022_e23eb275-ce0c-40ec-b809-a48c5e46c7ec 63187-022 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Proficient Rx LP IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63187-023_5e7e3225-3a08-436a-a51f-511cef9f0870 63187-023 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 19851223 NDA NDA018810 Proficient Rx LP SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 63187-024_d8235017-cb52-44d4-a6e6-6ee3f00c47d2 63187-024 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 19931129 ANDA ANDA064052 Proficient Rx LP TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 63187-025_2c8228b5-0e40-442f-8ed6-b08bcc857ba1 63187-025 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 Proficient Rx LP TRIAMCINOLONE ACETONIDE 1 mg/g 63187-026_6dc143e7-6bab-42c8-b3e9-9d604d202e73 63187-026 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 Proficient Rx LP ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 63187-027_5d080267-a1ad-4714-8fcd-ca291fbd1ef4 63187-027 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin POWDER, FOR SUSPENSION ORAL 19990415 NDA NDA050760 Proficient Rx LP AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63187-028_85ea0d74-f60a-420a-ac24-f3300e0838c6 63187-028 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Proficient Rx LP NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63187-029_832d74a7-6cc4-479c-84df-a5b05db0131d 63187-029 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 Proficient Rx LP AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63187-030_cdcd804e-f35c-4b06-85c3-e9f5e747974f 63187-030 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20060524 ANDA ANDA077893 Proficient Rx LP POLYETHYLENE GLYCOL 3350 17 g/1 Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 63187-031_3f356d7e-2609-4e3a-9c37-32f5a080f539 63187-031 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Proficient Rx LP GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63187-032_482511ed-4531-45ec-a4eb-c600aeb03325 63187-032 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065101 Proficient Rx LP AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 63187-033_f81eff3b-8386-45a6-9d00-a58634e31ffa 63187-033 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19840626 ANDA ANDA019117 Proficient Rx LP FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63187-034_664d2b50-b88d-4727-ba57-a05dfcff0fce 63187-034 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 Proficient Rx LP HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 63187-035_e51f7a62-9d4e-412d-b392-e2e2053eadb4 63187-035 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070033 Proficient Rx LP METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 63187-036_e6b04358-0f4c-4b21-a7f3-320d1e7bc0b8 63187-036 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Proficient Rx LP MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 63187-037_7d52bf53-76e3-4826-a12b-b16a8560bafc 63187-037 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Proficient Rx LP PREDNISONE 10 mg/1 63187-038_ddaaedfc-2740-48cc-9d69-f9856fa0c378 63187-038 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20090127 ANDA ANDA040863 Proficient Rx LP PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 63187-039_45b1c4da-11ac-4e3a-8c77-0b0cdb78df24 63187-039 HUMAN OTC DRUG TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sulfate OINTMENT TOPICAL 20030101 OTC MONOGRAPH FINAL part333B Proficient Rx LP BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 63187-040_a3eff326-b2c6-4e2a-a424-912511433467 63187-040 HUMAN OTC DRUG Q Tussin DM Dextromethorphan HBr and Guaifenesin SYRUP ORAL 19950401 OTC MONOGRAPH FINAL part341 Proficient Rx LP DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 63187-041_c5cd2b99-7c38-4cd8-ba54-8bc12f939061 63187-041 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960308 ANDA ANDA020254 Proficient Rx LP DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63187-042_bcbdde77-d288-4613-a4c3-ffa20ba7c7ab 63187-042 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110208 ANDA ANDA090797 Proficient Rx LP PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 63187-043_61bd8983-9890-463c-be87-aa42af9778c9 63187-043 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19880225 ANDA ANDA062884 Proficient Rx LP AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63187-044_70231a3f-e266-488f-bdfa-d88e3da3464f 63187-044 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120112 ANDA ANDA062058 Proficient Rx LP AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63187-045_1a2203e9-09ae-4b74-9df7-4ac51446035b 63187-045 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062935 Proficient Rx LP PENICILLIN V POTASSIUM 500 mg/1 63187-046_dec3a1ef-1e85-4236-804b-e7a343d3a58f 63187-046 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060111 ANDA ANDA065229 Proficient Rx LP CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63187-047_3c58bd59-7d8a-4216-8781-cdcdec5a5499 63187-047 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Proficient Rx LP LEVOFLOXACIN 500 mg/1 63187-048_3c58bd59-7d8a-4216-8781-cdcdec5a5499 63187-048 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Proficient Rx LP LEVOFLOXACIN 750 mg/1 63187-049_68daf82a-334e-43ca-b4bb-5c66a82f52c8 63187-049 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Proficient Rx LP SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 63187-050_af0b3bef-be36-432a-884e-ea81e2d5c08e 63187-050 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20030301 ANDA ANDA076194 Proficient Rx LP HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63187-051_af0b3bef-be36-432a-884e-ea81e2d5c08e 63187-051 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20030301 ANDA ANDA076194 Proficient Rx LP HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63187-052_57c5f95c-6048-4776-8c06-398668624a00 63187-052 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 Proficient Rx LP BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 63187-053_73346bc7-dcb8-452f-9c8f-5e6a83c09096 63187-053 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 Proficient Rx LP TRIAMCINOLONE ACETONIDE 1 mg/g 63187-054_7e6ff7b1-bd5c-475c-a6af-eac7f10fd2ea 63187-054 HUMAN PRESCRIPTION DRUG MonoNessa norgestimate and ethinyl estradiol KIT 20030101 NDA NDA019653 Proficient Rx LP 63187-055_266ed80f-d369-452e-b804-f32962588be3 63187-055 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Proficient Rx LP SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63187-056_3f356d7e-2609-4e3a-9c37-32f5a080f539 63187-056 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Proficient Rx LP GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63187-058_dba6c34f-82e4-49fc-bbe3-97eaabaac1d3 63187-058 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL; SUBLINGUAL 20090921 UNAPPROVED DRUG OTHER Proficient Rx LP HYOSCYAMINE SULFATE .125 mg/1 63187-059_a30c583a-4b0a-43a6-ae76-19b1a5e916ca 63187-059 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Proficient Rx LP TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63187-060_a30c583a-4b0a-43a6-ae76-19b1a5e916ca 63187-060 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Proficient Rx LP TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63187-061_03ac077f-3873-4087-96d0-89049161dea9 63187-061 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 Proficient Rx LP OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 63187-062_bb91769e-bbb6-4fe1-a203-adbb94d00b94 63187-062 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120314 NDA NDA022370 Proficient Rx LP TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 63187-063_f12e1521-472c-4366-9d3a-92df57813927 63187-063 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 Proficient Rx LP TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 63187-064_15aa57c4-c881-485a-9318-9fdaaff2e12e 63187-064 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20100723 ANDA ANDA091004 Proficient Rx LP ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 63187-065_cb467566-7df4-480d-a374-5ad8af114330 63187-065 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Proficient Rx LP ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63187-066_7d52bf53-76e3-4826-a12b-b16a8560bafc 63187-066 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Proficient Rx LP PREDNISONE 5 mg/1 63187-067_4c5c0ed8-fe43-4693-83f3-25b6c16b74c6 63187-067 HUMAN OTC DRUG MEDI-SULTING TOPICAL PAIN RELIEF METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE PATCH TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP CAPSAICIN; LIDOCAINE; MENTHOL; METHYL SALICYLATE .035; .5; 5; 20 g/100g; g/100g; g/100g; g/100g 63187-069_0a512b40-d7ee-4c45-957b-ab90a3c46c5e 63187-069 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Proficient Rx LP FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63187-070_03ac077f-3873-4087-96d0-89049161dea9 63187-070 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 Proficient Rx LP OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 63187-071_364fe10e-11ca-4ee6-9f67-c85dec09aca5 63187-071 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Proficient Rx LP LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63187-072_364fe10e-11ca-4ee6-9f67-c85dec09aca5 63187-072 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Proficient Rx LP LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63187-073_01da05d8-e72e-4208-bf92-a5cd929f15ab 63187-073 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080610 ANDA ANDA077626 Proficient Rx LP RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63187-074_7288899f-f4a8-454d-b407-23494cc9118f 63187-074 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100820 ANDA ANDA040807 Proficient Rx LP HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63187-075_6090fe0a-1fa7-493b-a6c6-1667fc98752c 63187-075 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Proficient Rx LP SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63187-076_19f1e761-69e9-4330-ad3c-1f1180d70cb0 63187-076 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 Proficient Rx LP BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 63187-077_a30c583a-4b0a-43a6-ae76-19b1a5e916ca 63187-077 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Proficient Rx LP TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63187-078_56e88a96-5be0-4a5c-995e-77c807c5294b 63187-078 HUMAN OTC DRUG Theragesic Creme METHYL SALICYLATE GEL TOPICAL 19810101 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP MENTHOL; METHYL SALICYLATE 10; 150 mg/g; mg/g 63187-079_9f9dd7b9-a072-46d0-a8b5-b3e138c85f1c 63187-079 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 19981002 NDA NDA020998 Proficient Rx LP CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63187-080_c7a36fd8-530e-4c63-97d5-0f80fab5880e 63187-080 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100628 ANDA ANDA090568 Proficient Rx LP ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 63187-081_0a512b40-d7ee-4c45-957b-ab90a3c46c5e 63187-081 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Proficient Rx LP FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63187-082_a2bbd8b6-a895-4db8-a50d-af5de01f2867 63187-082 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Proficient Rx LP MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63187-083_a2bbd8b6-a895-4db8-a50d-af5de01f2867 63187-083 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Proficient Rx LP MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63187-084_070e2547-8feb-4978-b149-55db5b680ef1 63187-084 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Proficient Rx LP ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 63187-085_66f2e530-70c7-4f5b-9b8a-6b775f421bd2 63187-085 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 Proficient Rx LP PREDNISONE 20 mg/1 63187-086_b99c3e52-d8df-422b-92b6-c82982edc283 63187-086 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 Proficient Rx LP TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 63187-087_96961faa-3009-49e4-bfb7-498bcc589aec 63187-087 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 Proficient Rx LP METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63187-088_8042270a-b58c-46ec-9c9e-6d8ea15de26e 63187-088 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073555 Proficient Rx LP NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 63187-089_e3e8aa9d-9daf-4565-85c9-a8d79c46128b 63187-089 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine CAPSULE ORAL 20050720 ANDA ANDA076990 Proficient Rx LP FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63187-090_da9c25c1-f65c-4dc6-8e13-f727c50fd4e4 63187-090 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Proficient Rx LP LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63187-091_7d37685b-91af-4c2d-9fb0-f036181c498c 63187-091 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Proficient Rx LP RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63187-092_347befff-4a62-4205-bcf4-77c03f8aafa4 63187-092 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Proficient Rx LP ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63187-093_7da117b1-c8f8-46a7-bcf1-60869611e9d1 63187-093 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20101217 ANDA ANDA065246 Proficient Rx LP AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 63187-094_f14bc532-e30f-490f-b97b-d0dab9a2ba0c 63187-094 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20120314 ANDA ANDA078048 Proficient Rx LP CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63187-095_3d235926-6f17-4aa5-be82-7f1b4357e247 63187-095 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20070103 ANDA ANDA076002 Proficient Rx LP BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE .5; 10 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63187-096_5cdb81b0-fbf6-4992-832c-5343ed006e3b 63187-096 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Proficient Rx LP FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 63187-097_fa22943c-27d3-4419-be9b-ffe7de1a2416 63187-097 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Proficient Rx LP FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63187-098_a67078e9-1806-4ee9-ad71-3b32435ce13d 63187-098 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Proficient Rx LP LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63187-099_74aeb6ec-01b0-4fbb-a4c4-4441eb92a2b3 63187-099 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Proficient Rx LP LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63187-101_b24f356a-7c1f-42ed-8cfc-9609830649bd 63187-101 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Proficient Rx LP METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 63187-102_b24f356a-7c1f-42ed-8cfc-9609830649bd 63187-102 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Proficient Rx LP METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 63187-103_7683d9c6-fe38-4623-a927-b8da85fab632 63187-103 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20040115 ANDA ANDA076670 Proficient Rx LP METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63187-104_d265f12d-8237-429a-b7f0-736dc147f0fb 63187-104 HUMAN OTC DRUG good sense all day pain relief Naproxen Sodium TABLET ORAL 19970114 ANDA ANDA074661 Proficient Rx LP NAPROXEN SODIUM 220 mg/1 63187-106_04fd835c-c080-4e12-8a00-eff3c6593927 63187-106 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 Proficient Rx LP ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 63187-107_3590f862-1148-4e8e-ad8a-aa8abc8945af 63187-107 HUMAN OTC DRUG Flexall Pain Relieving Menthol GEL TOPICAL 19970101 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP MENTHOL .16 g/g 63187-110_d14feb90-3ca2-4d5b-825c-25fc2252ca38 63187-110 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Proficient Rx LP CETIRIZINE HYDROCHLORIDE 10 mg/1 63187-111_76f7525d-2005-4da8-a795-50ede6236c68 63187-111 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Proficient Rx LP TERBINAFINE HYDROCHLORIDE 1 g/100g 63187-112_7b56e130-2ecb-4d15-8718-59ae0216e6f4 63187-112 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 Proficient Rx LP ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 63187-113_912684e3-b804-486e-a5e6-8f3b6919d378 63187-113 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20140601 ANDA ANDA040755 Proficient Rx LP CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63187-114_25e71199-c55d-4cc6-8388-b309d654d2b0 63187-114 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090107 Proficient Rx LP ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 63187-115_0f3a816d-82f9-4ebf-bae4-931ae6dfc32f 63187-115 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Proficient Rx LP ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 63187-116_0f3a816d-82f9-4ebf-bae4-931ae6dfc32f 63187-116 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Proficient Rx LP ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 63187-117_49e75518-f02b-4251-8239-c71c3376cadc 63187-117 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate SOLUTION ORAL 20061001 OTC MONOGRAPH FINAL part341 Proficient Rx LP CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 63187-118_e59656d2-26c5-432e-ba8e-c334da95d7a9 63187-118 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Proficient Rx LP TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63187-119_5e87beee-389e-437c-9761-37cfe015ec73 63187-119 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071219 ANDA ANDA077056 Proficient Rx LP PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 63187-120_197cb84a-d408-4848-83a9-4b974b8f91c9 63187-120 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040746 Proficient Rx LP ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 63187-121_da9b993d-3eb5-4b11-a292-62e378d70fb2 63187-121 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Proficient Rx LP NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63187-122_7d8e6c49-2d34-4aee-bd20-98b6023c7ed2 63187-122 HUMAN OTC DRUG MEDI-SULTING TOPICAL PAIN RELIEF METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE CREAM TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP CAPSAICIN; LIDOCAINE; MENTHOL; METHYL SALICYLATE .0355; 4; 5; 20 g/100mL; g/100mL; g/100mL; g/100mL 63187-123_d88c45a4-7478-497d-93e1-15629181f650 63187-123 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20110829 ANDA ANDA078722 Proficient Rx LP CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63187-124_fe3b3c55-c5d1-413f-a42e-2aaefcc2c029 63187-124 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140127 ANDA ANDA077284 Proficient Rx LP BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 63187-126_21fa0642-c108-4c90-935c-5fae1d28f442 63187-126 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine GEL TOPICAL 20130301 UNAPPROVED DRUG OTHER Proficient Rx LP LIDOCAINE 30 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63187-127_d6e1a5f2-9dcb-49fb-a5b0-d7d543520ac3 63187-127 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090826 ANDA ANDA065442 Proficient Rx LP CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 63187-128_f5170993-81a9-4eb7-95ac-60697a5ee1d7 63187-128 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 19980617 ANDA ANDA074754 Proficient Rx LP KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63187-130_ac07197b-9e64-410f-9c45-afea1c35c9e6 63187-130 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130115 ANDA ANDA086988 Proficient Rx LP METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63187-131_c03bd9d7-1e0b-49da-a14a-32e712dc3a2d 63187-131 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Proficient Rx LP CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 63187-132_904b8986-24da-48eb-bb0a-33d41b4eb005 63187-132 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 Proficient Rx LP TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63187-133_b99c3e52-d8df-422b-92b6-c82982edc283 63187-133 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 Proficient Rx LP TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 63187-135_a40926ca-7f3d-4331-babd-9ff9c6f009b9 63187-135 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20001201 ANDA ANDA065055 Proficient Rx LP DOXYCYCLINE 100 mg/1 63187-136_7e765fc1-74c6-4af3-a9cf-05b57011d7d8 63187-136 HUMAN OTC DRUG Dendracin Neurodendraxcin Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20110722 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP CAPSAICIN; MENTHOL; METHYL SALICYLATE .015; 6; 18 g/60mL; g/60mL; g/60mL 63187-137_a769150d-d2b3-4ec8-be4d-42a57b2f4210 63187-137 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Proficient Rx LP ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 63187-138_07e8c29f-cc38-4a9c-b4cf-3e210d64bd1e 63187-138 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20060329 ANDA ANDA065255 Proficient Rx LP AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63187-139_81d1e979-2bc1-4ee1-a5b3-80a43a9cadde 63187-139 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110127 ANDA ANDA075661 Proficient Rx LP IBUPROFEN 200 mg/1 63187-140_f37cc307-8b7d-4e5c-8beb-cd8779bc86a7 63187-140 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Proficient Rx LP CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63187-141_2a2f032b-4ece-46bb-82aa-09decbe60441 63187-141 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Proficient Rx LP CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 63187-142_2822a7b4-3b56-41ff-8992-2a6dd268907c 63187-142 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Proficient Rx LP CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 63187-143_f173ff13-7417-415b-8725-3c2f2dd3e5b5 63187-143 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Proficient Rx LP AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63187-144_355f5170-b129-4ac9-be61-ea70b04c4ee5 63187-144 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20130812 ANDA ANDA040526 Proficient Rx LP PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 63187-145_9d9b9e41-42ee-446f-80ae-da2333c3dbdd 63187-145 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 Proficient Rx LP TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 63187-146_2b916bf7-1c69-412a-8dab-40294d34df2d 63187-146 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20110101 ANDA ANDA077836 Proficient Rx LP GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 63187-147_8041f771-cf94-454c-a523-16cb9e9f81f3 63187-147 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072234 Proficient Rx LP BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 63187-148_c79d94ec-117d-4fb6-845d-1954e3472bb0 63187-148 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111006 ANDA ANDA200651 Proficient Rx LP GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63187-149_ede081e5-3847-41fc-9025-a8ec21b87b44 63187-149 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20121029 ANDA ANDA202764 Proficient Rx LP GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63187-151_d8766748-6b53-4673-a3ee-5cd8a4301647 63187-151 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20050923 ANDA ANDA065170 Proficient Rx LP MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 63187-152_7d811f01-f0c2-4753-bb36-80b48dabb58c 63187-152 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091111 ANDA ANDA077255 Proficient Rx LP LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 63187-153_8042270a-b58c-46ec-9c9e-6d8ea15de26e 63187-153 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073555 Proficient Rx LP NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 63187-154_0d088c7f-d806-49da-a34a-46d86e6ca173 63187-154 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 19970423 ANDA ANDA074578 Proficient Rx LP ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63187-156_da7c5db6-a950-401c-90ed-c2ca433b2bb3 63187-156 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Proficient Rx LP AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 63187-157_31bcbdbc-43d6-42a2-b105-9edbb438bddd 63187-157 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100218 ANDA ANDA078218 Proficient Rx LP CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63187-158_4dc7a892-2419-4850-b691-e03ecc2e75f7 63187-158 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium rabeprazole TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA076885 Proficient Rx LP RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 63187-159_7d37685b-91af-4c2d-9fb0-f036181c498c 63187-159 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Proficient Rx LP RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63187-161_97f8d67d-c422-4a26-9394-24a5ec9719d9 63187-161 HUMAN PRESCRIPTION DRUG mupirocin Mupirocin OINTMENT TOPICAL 20091030 ANDA ANDA065123 Proficient Rx LP MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 63187-162_a4ba3e83-ca7c-4ff2-824c-77fe08e1586c 63187-162 HUMAN OTC DRUG LenzaPatch LIDOCAINE HYDROCHLORIDE, MENTHOL LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g 63187-163_3ab508ed-4b12-4dd7-a13e-1a071f560286 63187-163 HUMAN PRESCRIPTION DRUG GENTAMICIN SULFATE gentamicin sulfate SOLUTION/ DROPS OPHTHALMIC 19980105 ANDA ANDA062452 Proficient Rx LP GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 63187-164_5cba3661-9b16-416b-b0c0-bbb12549d48f 63187-164 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUMATRIPTAN TABLET ORAL 20090813 ANDA ANDA076554 Proficient Rx LP SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 63187-166_5e800ed9-c0c4-42d7-904a-4b4937aa4e45 63187-166 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Proficient Rx LP IBUPROFEN 100 mg/5mL 63187-167_b98dbda3-a5b5-4a2c-a4a3-e6f6adf199a2 63187-167 HUMAN OTC DRUG Good Sense Allergy Relief diphenhydramine hydrochloride CAPSULE ORAL 19890915 OTC MONOGRAPH FINAL part341 Proficient Rx LP DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63187-169_1926be99-3b3e-45ff-a1b9-4eb31312dd57 63187-169 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065211 Proficient Rx LP AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 63187-172_35ec3eb6-aa04-4375-acb6-ac708200d912 63187-172 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Proficient Rx LP DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63187-173_e7542d46-2586-4225-b07d-2633116bfa0a 63187-173 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071321 Proficient Rx LP DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63187-174_7683d9c6-fe38-4623-a927-b8da85fab632 63187-174 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20040115 ANDA ANDA076670 Proficient Rx LP METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63187-175_2c7ee4be-3fe1-4b45-b56e-56bc85e2bf6a 63187-175 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Proficient Rx LP ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 63187-177_9f697c00-f5ec-454a-a66c-503aef5fc609 63187-177 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Proficient Rx LP VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63187-178_57c5f95c-6048-4776-8c06-398668624a00 63187-178 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 Proficient Rx LP BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 63187-180_859e9681-9324-4d57-ac20-660e89600f0f 63187-180 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20140415 ANDA ANDA091153 Proficient Rx LP ESZOPICLONE 1 mg/1 CIV 63187-181_35ec3eb6-aa04-4375-acb6-ac708200d912 63187-181 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Proficient Rx LP DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63187-185_bc912150-09fa-48ea-8dab-ecec9353e74c 63187-185 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Proficient Rx LP BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 63187-186_de792ac6-4b3d-4d34-8e50-030b5bd830d7 63187-186 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 Proficient Rx LP AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63187-188_32d09bd1-f31d-4f39-9600-f80b4eff02f1 63187-188 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20110301 ANDA ANDA075693 Proficient Rx LP IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 63187-189_a6c8c7c3-2449-44f2-9f3b-597cb5c3a2cb 63187-189 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065225 Proficient Rx LP AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 63187-191_6090fe0a-1fa7-493b-a6c6-1667fc98752c 63187-191 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Proficient Rx LP SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63187-195_832d74a7-6cc4-479c-84df-a5b05db0131d 63187-195 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 Proficient Rx LP AMOXICILLIN 600 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63187-197_61837ac5-0a0b-4ea9-b71c-d4c753294ed6 63187-197 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Proficient Rx LP AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63187-198_61837ac5-0a0b-4ea9-b71c-d4c753294ed6 63187-198 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Proficient Rx LP AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63187-199_2eb9118f-7747-41a4-9963-d9a7d17bd4d2 63187-199 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Proficient Rx LP ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63187-203_1a136cc3-d655-4f3c-8710-2603dc008492 63187-203 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Proficient Rx LP CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63187-204_d3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b 63187-204 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19970917 ANDA ANDA074880 Proficient Rx LP ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 63187-205_febab51b-6b48-488a-8fd1-d24400e5df1d 63187-205 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 Proficient Rx LP CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63187-208_53d51b12-49f6-4c53-87a9-97bc1b44fd7f 63187-208 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20061227 ANDA ANDA077657 Proficient Rx LP LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63187-209_f0712b47-1afb-46fb-8860-c23b1c79f223 63187-209 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Proficient Rx LP RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 63187-210_f0712b47-1afb-46fb-8860-c23b1c79f223 63187-210 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Proficient Rx LP RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 63187-211_f0712b47-1afb-46fb-8860-c23b1c79f223 63187-211 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Proficient Rx LP RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 63187-212_266ed80f-d369-452e-b804-f32962588be3 63187-212 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Proficient Rx LP SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63187-213_87cac9b2-473a-449a-a678-11118097dc7f 63187-213 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine TABLET ORAL 20110101 ANDA ANDA077533 Proficient Rx LP TERBINAFINE HYDROCHLORIDE 250 1/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 63187-214_73346bc7-dcb8-452f-9c8f-5e6a83c09096 63187-214 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 Proficient Rx LP TRIAMCINOLONE ACETONIDE .025 mg/g 63187-216_06b8d913-95d5-4a42-a542-bc9ede2e9a0d 63187-216 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA201522 Proficient Rx LP MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 63187-217_eecd1c8c-9e8f-4618-8d71-b1d8116bd6d7 63187-217 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Proficient Rx LP ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63187-218_d7144d7f-9d54-4fb0-a78e-c99a2e09987b 63187-218 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride TABLET, FILM COATED ORAL 20020130 ANDA ANDA075872 Proficient Rx LP FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63187-219_8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60 63187-219 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Proficient Rx LP QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 63187-220_1a136cc3-d655-4f3c-8710-2603dc008492 63187-220 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Proficient Rx LP CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63187-222_73a46413-ecbc-4453-814d-bec955b375d2 63187-222 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 Proficient Rx LP DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63187-226_56175c25-3fde-43ea-89bf-22dcf3278b6b 63187-226 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960918 ANDA ANDA074569 Proficient Rx LP CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63187-227_8042270a-b58c-46ec-9c9e-6d8ea15de26e 63187-227 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073555 Proficient Rx LP NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 63187-228_e9c4e279-0ef9-4e96-8741-dfe7556953d9 63187-228 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Proficient Rx LP TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63187-230_e59656d2-26c5-432e-ba8e-c334da95d7a9 63187-230 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Proficient Rx LP TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63187-232_afd25943-5e7e-47f8-ad32-120b2dd1a3f1 63187-232 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 Proficient Rx LP DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 63187-233_1a2a5194-b793-4c62-a177-040dad38526b 63187-233 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Proficient Rx LP FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63187-234_72c6d6cb-a82d-4a45-a7f9-fad60a271fa4 63187-234 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Proficient Rx LP GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 63187-235_ce367a41-89d3-45c2-aac2-36fce43062d0 63187-235 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 Proficient Rx LP METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 63187-236_cb467566-7df4-480d-a374-5ad8af114330 63187-236 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Proficient Rx LP ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63187-237_a67078e9-1806-4ee9-ad71-3b32435ce13d 63187-237 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Proficient Rx LP LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63187-238_1b9b6db9-1bac-4252-a03c-18dc0271f05f 63187-238 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Proficient Rx LP METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 63187-239_1b9b6db9-1bac-4252-a03c-18dc0271f05f 63187-239 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Proficient Rx LP METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 63187-241_6b6ad6c8-22f8-456b-bc54-a02fb6cbea8c 63187-241 HUMAN PRESCRIPTION DRUG valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA203026 Proficient Rx LP HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63187-242_9aa1a129-f845-45ab-b01e-4f4f5063d1e1 63187-242 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Proficient Rx LP PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 63187-244_a21cdb0e-69ee-4d2f-a45c-1693b7bca238 63187-244 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20050527 ANDA ANDA040574 Proficient Rx LP HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 63187-245_3b53f9bf-866a-4cb1-9180-7b13896e26ba 63187-245 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Proficient Rx LP NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 63187-246_9aa1a129-f845-45ab-b01e-4f4f5063d1e1 63187-246 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Proficient Rx LP PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 63187-247_2a2f032b-4ece-46bb-82aa-09decbe60441 63187-247 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Proficient Rx LP CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 63187-248_3f356d7e-2609-4e3a-9c37-32f5a080f539 63187-248 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Proficient Rx LP GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63187-249_1a528236-6375-4630-b4e1-8db250a4cbef 63187-249 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20110715 ANDA ANDA090618 Proficient Rx LP NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63187-250_6fa203ab-2822-4394-8f17-83f6eeaec626 63187-250 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Proficient Rx LP CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 63187-251_565e4b1b-04be-47b4-99b0-903fc2ed47af 63187-251 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine maleate TABLET ORAL 19980301 ANDA ANDA040268 Proficient Rx LP PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 63187-253_c55bde35-a202-4c25-b545-e5d5e95c1175 63187-253 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131129 ANDA ANDA203834 Proficient Rx LP ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63187-254_4148ea73-47a7-46d6-9b10-a815afc9c463 63187-254 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19771117 ANDA ANDA085762 Proficient Rx LP ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 63187-255_2e51d1ae-a486-4d7a-b5ee-2324c8c42fb2 63187-255 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110301 ANDA ANDA074550 Proficient Rx LP GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 63187-256_2eb9118f-7747-41a4-9963-d9a7d17bd4d2 63187-256 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Proficient Rx LP ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63187-257_a67078e9-1806-4ee9-ad71-3b32435ce13d 63187-257 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Proficient Rx LP LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63187-258_91b1fd1a-1da2-4aae-826f-7de0bfe62161 63187-258 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120430 ANDA ANDA200294 Proficient Rx LP MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 63187-259_14412af6-e99c-4264-bc34-28a6f139f252 63187-259 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole Sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA090678 Proficient Rx LP RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 63187-263_22061f76-2c05-4501-b8dd-a5c372abe7c2 63187-263 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 Proficient Rx LP NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 63187-264_088dc3dd-7740-471b-8c06-5a47900ae5b5 63187-264 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20140423 ANDA ANDA201003 Proficient Rx LP RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 63187-265_e9ea2f77-11c3-4dbf-bdc4-d1b0e7437990 63187-265 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20100511 ANDA ANDA090121 Proficient Rx LP FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 63187-267_62896bec-669e-4f20-a1e4-4f99afd35d32 63187-267 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19960718 ANDA ANDA064030 Proficient Rx LP ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 63187-268_c8020ad4-ac74-4ceb-863e-94da605cf23f 63187-268 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20040514 ANDA ANDA076622 Proficient Rx LP OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 63214-100_8f89d317-e696-4eed-9ddb-d8b8f885d9dd 63214-100 HUMAN OTC DRUG Therapytion Nokmosu Hair Tonic salicylic acid,panthenol SPRAY TOPICAL 20140501 UNAPPROVED DRUG OTHER Therapytion Co., Ltd. PANTHENOL; SALICYLIC ACID .24; .3 g/120g; g/120g 63214-101_dc7e61b1-f3fc-44e7-8ab7-298449b4cc11 63214-101 HUMAN OTC DRUG Therapytion Nokmosu Sensitive and Dry Hair zinc pyrithione, panthenol, niacinamide, biotin SHAMPOO TOPICAL 20140501 UNAPPROVED DRUG OTHER Therapytion Co., Ltd. BIOTIN; NIACINAMIDE; PANTHENOL; PYRITHIONE ZINC .06; .3; .5; 2.1 g/530g; g/530g; g/530g; g/530g 63214-102_41ac95c4-a5f8-4199-b354-067982deb899 63214-102 HUMAN OTC DRUG Therapytion Nokmosu Neutral and oily Hair zinc pyrithione, panthenol, niacinamide, biotin SHAMPOO TOPICAL 20140501 UNAPPROVED DRUG OTHER Therapytion Co., Ltd. BIOTIN; NIACINAMIDE; PANTHENOL; PYRITHIONE ZINC .06; .3; .5; 2.1 g/530g; g/530g; g/530g; g/530g 63215-001_a6e1761b-67b6-40fb-88fc-e793720d7980 63215-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Broadway Home Medical OXYGEN 99 L/100L 63218-4000_ecdf1c1a-2824-40c6-8645-9a59e64ee10b 63218-4000 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19970317 UNAPPROVED MEDICAL GAS Arizona Respiratory & Medical Supply Services, Inc. OXYGEN 99 L/100L 63219-100_96bd1b57-db3a-4c94-8ecb-adaa8c3bcca5 63219-100 HUMAN OTC DRUG MAMACHI MOMS STRETCH MARK CREAM Adenosine CREAM TOPICAL 20140501 UNAPPROVED DRUG OTHER Supio Co,. Ltd. ADENOSINE 6 g/150g 63234-001_ddf4331b-f8af-4093-8be2-dc80b9b06bb2 63234-001 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 20110101 UNAPPROVED MEDICAL GAS Olympic Pharmacy and Healthcare Services OXYGEN 99.4 L/100L 63240-5000_22162b5f-c013-47c2-9da6-4ffd75779a47 63240-5000 HUMAN OTC DRUG Shunga Sensation Balm Benzocain GEL TOPICAL 20000101 OTC MONOGRAPH FINAL part348 Eau Zone Oils and Fragrances LTD BENZOCAINE 5.07 g/67.5g 63240-5001_22162b5f-c013-47c2-9da6-4ffd75779a47 63240-5001 HUMAN OTC DRUG Shunga Sensation Balm Benzocain GEL TOPICAL 20000101 OTC MONOGRAPH FINAL part348 Eau Zone Oils and Fragrances LTD BENZOCAINE 5.06 g/67.5g 63240-5002_22162b5f-c013-47c2-9da6-4ffd75779a47 63240-5002 HUMAN OTC DRUG Shunga Sensation Balm Benzocain GEL TOPICAL 20000101 OTC MONOGRAPH FINAL part348 Eau Zone Oils and Fragrances LTD BENZOCAINE 5.07 g/67.5g 63240-5003_22162b5f-c013-47c2-9da6-4ffd75779a47 63240-5003 HUMAN OTC DRUG Shunga Sensation Balm Benzocain GEL TOPICAL 20050101 OTC MONOGRAPH FINAL part348 Eau Zone Oils and Fragrances LTD BENZOCAINE 5.07 g/67.5g 63240-5100_19c2c1b8-76c3-4a96-9f46-8193e9e92b3f 63240-5100 HUMAN OTC DRUG Shunga Male Genital Desensitizer Benzocaine AEROSOL, SPRAY TOPICAL 20100801 OTC MONOGRAPH FINAL part348 Eau Zone Oils & Fragrances LTD BENZOCAINE 1.125 g/15g 63255-001_f7682908-5d83-4b5f-a879-a5b8dbaa556e 63255-001 HUMAN OTC DRUG HYSAN HUA TUO MEDICATED PLASTER Menthol, Methyl Salicylate PLASTER TOPICAL 20131204 OTC MONOGRAPH NOT FINAL part348 HYSAN PHARMACEUTICAL CO LTD MENTHOL; METHYL SALICYLATE 5; 1 g/1; g/1 63255-002_4106cec3-2969-4bb1-acfe-1ed26b8777fd 63255-002 HUMAN OTC DRUG HYSAN DEGUO POROUS CAPSICUM Capsicum PLASTER TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part348 HYSAN PHARMACEUTICAL CO LTD CAPSICUM 3 g/1 63255-010_f88ff856-323d-40f6-8676-8e8e3115b823 63255-010 HUMAN OTC DRUG HYSAN HUO LU MEDICATED Methyl Salicylate, Menthol, Camphor (Synthetic) OIL TOPICAL 20131204 OTC MONOGRAPH NOT FINAL part348 HYSAN PHARMACEUTICAL CO LTD CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 10; 36; 40 g/100mL; g/100mL; g/100mL 63255-011_33cca65e-850c-4c5d-88af-ec2cc80b3791 63255-011 HUMAN OTC DRUG Hua Tuo Huo Lu Oil Methyl Salicylate, Menthol, Camphor (Synthetic) OIL TOPICAL 20131127 OTC MONOGRAPH NOT FINAL part348 Hysan Pharmaceutical Co Ltd CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 10; 36; 40 g/100mL; g/100mL; g/100mL 63255-021_69568bb3-b63f-48ea-85d5-30774710dda0 63255-021 HUMAN OTC DRUG HYSAN PAIN RELIEVER METHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC), EUCALYPTUS OIL OIL TOPICAL 20120920 OTC MONOGRAPH NOT FINAL part348 HYSAN PHARMACEUTICAL CO LTD CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL; METHYL SALICYLATE 10; 10; 36; 37 g/100mL; g/100mL; g/100mL; g/100mL 63255-030_274e84e2-2368-4b3e-9b7b-30b8c7489005 63255-030 HUMAN OTC DRUG CORAL ANALGESIC METHYL SALICYLATE, EUCALYPTUS OIL, MENTHOL CRYSTAL, CAMPHOR (SYNTHETIC) OINTMENT TOPICAL 20140127 OTC MONOGRAPH NOT FINAL part348 HYSAN PHARMACEUTICAL CO LTD CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL; METHYL SALICYLATE 2; 11; 11; 22 g/100g; g/100g; g/100g; g/100g 63256-100_05246011-b7f0-40a3-ac67-b1bd8d23edac 63256-100 HUMAN PRESCRIPTION DRUG Sclerosol Talc AEROSOL, POWDER INTRAPLEURAL 20130630 NDA NDA020587 Bryan Corp TALC 4 g/25g 63256-200_ffa7f6f2-0d63-42b4-bb48-34217d871a91 63256-200 HUMAN PRESCRIPTION DRUG Sterile Talc Talc POWDER INTRAPLEURAL 20031215 NDA NDA021388 Bryan Corporation TALC 5 g/100mL 63261-250_2a25e7c7-d5f4-40b6-82b8-74aabc34b3e4 63261-250 HUMAN PRESCRIPTION DRUG LYMPHAZURIN isosulfan blue INJECTION, SOLUTION SUBCUTANEOUS 20120112 NDA NDA018310 UNITED STATES SURGICAL CORPORATION ISOSULFAN BLUE 10 mg/mL 63264-101_adb612e8-d201-46c8-812b-5f48cafd322f 63264-101 HUMAN OTC DRUG SWIMMERS ITCH GUARD SPF 30 ZINC OXIDE, EUCALYPTUS OIL CREAM TOPICAL 20131229 OTC MONOGRAPH FINAL part352 RESOLUTIONS LLC ZINC OXIDE 15 g/100mL 63286-0134_0cb8e560-636f-4127-b802-cdfd8f23147f 63286-0134 HUMAN PRESCRIPTION DRUG Magnesium Chloride magnesium chloride INJECTION INTRAVENOUS 20130314 UNAPPROVED DRUG OTHER Mylan Teoranta MAGNESIUM CHLORIDE 200 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 63287-211_7f9c2965-f41f-4a7d-9c36-4f1b59d90d38 63287-211 HUMAN OTC DRUG Throat-Releev (Honey and Lemon) Benzalkonium Chloride LIQUID TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part333A Merix Pharmaceutical Corp. BENZALKONIUM CHLORIDE 1.3 mg/mL 63287-419_b875d2e8-9bb0-4872-9411-c4f003e1f029 63287-419 HUMAN OTC DRUG Releev Cold Sore Treatment Benzalkonium Chloride LIQUID TOPICAL 20060601 OTC MONOGRAPH NOT FINAL part333A Merix Pharmaceutical Corp. BENZALKONIUM CHLORIDE 1.3 mg/mL 63287-420_9f42dc8f-e1fb-4514-92dd-bb55fab3ea3f 63287-420 HUMAN OTC DRUG shing-Releev Benzalkonium Chloride LIQUID TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part333A Merix Pharmaceutical Corp. ALLANTOIN; BENZALKONIUM CHLORIDE; BENZYL ALCOHOL 5; 1.3; 5 mg/mL; mg/mL; mg/mL 63287-425_9fa64ca3-1231-4922-9b52-295f1869746e 63287-425 HUMAN OTC DRUG Fast Results Genital Herpes Treatment Benzalkonium Chloride,Allantoin LIQUID TOPICAL 20060601 OTC MONOGRAPH NOT FINAL part333A Merix Pharmaceutical Corp. ALLANTOIN; BENZALKONIUM CHLORIDE 5; 1.3 mL/mL; mL/mL 63289-001_3d49eb0a-d307-4ea9-a9c0-37319d56553b 63289-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19840101 UNAPPROVED MEDICAL GAS Landauer Metropolitan, Inc OXYGEN 99 L/100L 63293-0001_b69ef924-6f29-41cd-8fcf-663404082e71 63293-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020725 UNAPPROVED MEDICAL GAS Clay Home Medical OXYGEN 99 L/100L 63302-202_926ad67e-a2d7-44f1-9f94-b55d3ef83515 63302-202 HUMAN OTC DRUG Dermazor Psoriasis and Seborrheic Dermatitis Salicylic Acid, Zinc Oxide CREAM TOPICAL 20140505 OTC MONOGRAPH FINAL part333D PRESTIGIO LTD SALICYLIC ACID 3 g/100g 63304-097_fb990ab2-9b98-4fff-97e4-15bb638a6200 63304-097 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUMATRIPTAN TABLET ORAL 20090813 ANDA ANDA076554 Ranbaxy Pharmaceuticals Inc. SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 63304-098_fb990ab2-9b98-4fff-97e4-15bb638a6200 63304-098 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUMATRIPTAN TABLET ORAL 20090813 ANDA ANDA076554 Ranbaxy Pharmaceuticals Inc. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 63304-099_fb990ab2-9b98-4fff-97e4-15bb638a6200 63304-099 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUMATRIPTAN TABLET ORAL 20090210 ANDA ANDA076572 Ranbaxy Pharmaceuticals Inc. SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 63304-128_e045a98a-fd37-48c0-ba67-2889a4666d8c 63304-128 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20101129 ANDA ANDA076786 Ranbaxy Pharmaceuticals Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 63304-129_e045a98a-fd37-48c0-ba67-2889a4666d8c 63304-129 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20101129 ANDA ANDA076786 Ranbaxy Pharmaceuticals Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 63304-130_8ca80b44-e379-4739-a71b-a4c00d9df339 63304-130 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20061005 ANDA ANDA065356 Ranbaxy Pharmaceuticals Inc. DOXYCYCLINE 50 mg/1 63304-131_8ca80b44-e379-4739-a71b-a4c00d9df339 63304-131 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20061005 ANDA ANDA065356 Ranbaxy Pharmaceuticals Inc. DOXYCYCLINE 75 mg/1 63304-132_8ca80b44-e379-4739-a71b-a4c00d9df339 63304-132 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20061005 ANDA ANDA065356 Ranbaxy Pharmaceuticals Inc. DOXYCYCLINE 100 mg/1 63304-154_b0e9ccc3-d312-4906-a4da-b037118578e9 63304-154 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride and hydrochlorothiazide Benazepril hydrochloride and hydrochlorothiazide TABLET, COATED ORAL 20060410 ANDA ANDA077483 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63304-155_b0e9ccc3-d312-4906-a4da-b037118578e9 63304-155 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride and hydrochlorothiazide Benazepril hydrochloride and hydrochlorothiazide TABLET, COATED ORAL 20060410 ANDA ANDA077483 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63304-156_b0e9ccc3-d312-4906-a4da-b037118578e9 63304-156 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride and hydrochlorothiazide Benazepril hydrochloride and hydrochlorothiazide TABLET, COATED ORAL 20060410 ANDA ANDA077483 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63304-157_b0e9ccc3-d312-4906-a4da-b037118578e9 63304-157 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride and hydrochlorothiazide Benazepril hydrochloride and hydrochlorothiazide TABLET, COATED ORAL 20060410 ANDA ANDA077483 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63304-159_d7111557-1222-4567-a9e7-dee824645812 63304-159 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA078055 Ranbaxy Pharmaceuticals Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 63304-160_d7111557-1222-4567-a9e7-dee824645812 63304-160 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA078055 Ranbaxy Pharmaceuticals Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 63304-161_ca222b5d-5f85-4d4c-a608-72e916a34190 63304-161 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20090304 ANDA ANDA078211 Ranbaxy Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63304-162_ca222b5d-5f85-4d4c-a608-72e916a34190 63304-162 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20090304 ANDA ANDA078211 Ranbaxy Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63304-163_ca222b5d-5f85-4d4c-a608-72e916a34190 63304-163 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20090304 ANDA ANDA078211 Ranbaxy Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63304-164_442f6c6a-dc17-4153-a028-7ac339e768dc 63304-164 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, COATED ORAL 20070206 ANDA ANDA077977 Ranbaxy Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63304-165_442f6c6a-dc17-4153-a028-7ac339e768dc 63304-165 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, COATED ORAL 20070206 ANDA ANDA077977 Ranbaxy Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63304-166_442f6c6a-dc17-4153-a028-7ac339e768dc 63304-166 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, COATED ORAL 20070206 ANDA ANDA077977 Ranbaxy Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63304-167_442f6c6a-dc17-4153-a028-7ac339e768dc 63304-167 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, COATED ORAL 20070206 ANDA ANDA077977 Ranbaxy Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63304-168_442f6c6a-dc17-4153-a028-7ac339e768dc 63304-168 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, COATED ORAL 20070206 ANDA ANDA077977 Ranbaxy Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 200 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63304-173_8ca80b44-e379-4739-a71b-a4c00d9df339 63304-173 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20061005 ANDA ANDA065356 Ranbaxy Pharmaceuticals Inc. DOXYCYCLINE 150 mg/1 63304-191_fe600fb8-eb88-41dd-a52a-ac9edb2d870b 63304-191 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20130305 NDA NDA204150 Ranbaxy Pharmaceuticals Inc. DESVENLAFAXINE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 63304-192_fe600fb8-eb88-41dd-a52a-ac9edb2d870b 63304-192 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20130305 NDA NDA204150 Ranbaxy Pharmaceuticals Inc. DESVENLAFAXINE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 63304-193_c09d726b-9e74-4341-a991-ff126ce179b9 63304-193 HUMAN PRESCRIPTION DRUG Milnacipran hydrochloride Milnacipran hydrochloride TABLET, FILM COATED ORAL 20141127 ANDA ANDA205088 Ranbaxy Pharmaceuticals Inc. MILNACIPRAN HYDROCHLORIDE 12.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63304-194_c09d726b-9e74-4341-a991-ff126ce179b9 63304-194 HUMAN PRESCRIPTION DRUG Milnacipran hydrochloride Milnacipran hydrochloride TABLET, FILM COATED ORAL 20141127 ANDA ANDA205088 Ranbaxy Pharmaceuticals Inc. MILNACIPRAN HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63304-205_e1e45a3c-3b63-4c33-b500-d7c9cee0dbf6 63304-205 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride SYRUP ORAL 20020705 ANDA ANDA076058 Ranbaxy Pharmaceuticlas Inc MIDAZOLAM HYDROCHLORIDE 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63304-210_ab2722ce-c08e-4cdd-a25e-756272ea463f 63304-210 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20090818 ANDA ANDA040844 Ranbaxy Pharmaceuticals Inc. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 63304-211_ab2722ce-c08e-4cdd-a25e-756272ea463f 63304-211 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20090818 ANDA ANDA040844 Ranbaxy Pharmaceuticals Inc. GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 63304-212_c09d726b-9e74-4341-a991-ff126ce179b9 63304-212 HUMAN PRESCRIPTION DRUG Milnacipran hydrochloride Milnacipran hydrochloride TABLET, FILM COATED ORAL 20141127 ANDA ANDA205088 Ranbaxy Pharmaceuticals Inc. MILNACIPRAN HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63304-213_c09d726b-9e74-4341-a991-ff126ce179b9 63304-213 HUMAN PRESCRIPTION DRUG Milnacipran hydrochloride Milnacipran hydrochloride TABLET, FILM COATED ORAL 20141127 ANDA ANDA205088 Ranbaxy Pharmaceuticals Inc. MILNACIPRAN HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63304-214_510b79b4-038e-4df6-96ee-c519457f50bf 63304-214 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20080512 ANDA ANDA078722 Ranbaxy Pharmaceuticals Inc CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63304-215_510b79b4-038e-4df6-96ee-c519457f50bf 63304-215 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20080512 ANDA ANDA078722 Ranbaxy Pharmaceuticals Inc CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63304-216_510b79b4-038e-4df6-96ee-c519457f50bf 63304-216 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20080512 ANDA ANDA078722 Ranbaxy Pharmaceuticals Inc CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63304-239_7cf2c3e4-faa8-475c-b48c-0a8417fadb8c 63304-239 HUMAN PRESCRIPTION DRUG CALCITRIOL CALCITRIOL CAPSULE ORAL 20090826 NDA AUTHORIZED GENERIC NDA018044 Ranbaxy Pharmaceuticals Inc. CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 63304-240_7cf2c3e4-faa8-475c-b48c-0a8417fadb8c 63304-240 HUMAN PRESCRIPTION DRUG CALCITRIOL CALCITRIOL CAPSULE ORAL 20090826 NDA AUTHORIZED GENERIC NDA018044 Ranbaxy Pharmaceuticals Inc. CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 63304-241_7cf2c3e4-faa8-475c-b48c-0a8417fadb8c 63304-241 HUMAN PRESCRIPTION DRUG CALCITRIOL CALCITRIOL SOLUTION ORAL 20090826 NDA AUTHORIZED GENERIC NDA021068 Ranbaxy Pharmaceuticals Inc. CALCITRIOL 1 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 63304-254_58ac390f-98bb-4929-b1a7-7469630d5abb 63304-254 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130207 ANDA ANDA202467 Ranbaxy Pharmaceuticals Inc PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 63304-255_58ac390f-98bb-4929-b1a7-7469630d5abb 63304-255 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130207 ANDA ANDA202467 Ranbaxy Pharmaceuticals Inc PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 63304-261_58ac390f-98bb-4929-b1a7-7469630d5abb 63304-261 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130207 ANDA ANDA202467 Ranbaxy Pharmaceuticals Inc PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 63304-296_5a71ed2d-1d00-404e-bf2c-475cfd9e278c 63304-296 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20090107 ANDA ANDA040766 Ranbaxy Pharmaceuticals Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 63304-311_a2a31eaf-b314-445c-a7dd-42a363a04092 63304-311 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 Ranbaxy Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 63304-312_a2a31eaf-b314-445c-a7dd-42a363a04092 63304-312 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 Ranbaxy Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 63304-313_a2a31eaf-b314-445c-a7dd-42a363a04092 63304-313 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 Ranbaxy Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 63304-337_8fdc8bda-635a-401f-a9b5-8a2a514b429e 63304-337 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63304-338_8fdc8bda-635a-401f-a9b5-8a2a514b429e 63304-338 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63304-339_8fdc8bda-635a-401f-a9b5-8a2a514b429e 63304-339 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63304-340_8fdc8bda-635a-401f-a9b5-8a2a514b429e 63304-340 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63304-346_1b169f76-a9a5-4704-a81c-094b497217a7 63304-346 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20120110 ANDA ANDA078602 Rnabaxy Pharmaceuticals Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63304-347_1b169f76-a9a5-4704-a81c-094b497217a7 63304-347 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20120110 ANDA ANDA078602 Rnabaxy Pharmaceuticals Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63304-400_88603d5f-4ad0-46ab-999f-740312dc35dc 63304-400 HUMAN PRESCRIPTION DRUG Oxycodone HCl Controlled-Release Oxycodone HCl Controlled-Release TABLET ORAL 20100201 NDA NDA020553 Ranbaxy Pharmaceuticals Inc OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63304-401_88603d5f-4ad0-46ab-999f-740312dc35dc 63304-401 HUMAN PRESCRIPTION DRUG Oxycodone HCl Controlled-Release Oxycodone HCl Controlled-Release TABLET ORAL 20100201 NDA NDA020553 Ranbaxy Pharmaceuticals Inc OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63304-403_02e7b2aa-cc39-461b-b7b1-b0576b7c959e 63304-403 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20041220 ANDA ANDA076739 Ranbaxy Pharmaceuticals Inc. FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63304-404_02e7b2aa-cc39-461b-b7b1-b0576b7c959e 63304-404 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20041220 ANDA ANDA076739 Ranbaxy Pharmaceuticals Inc. FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63304-435_b951455c-c235-4e23-9e21-08672d108726 63304-435 HUMAN PRESCRIPTION DRUG FELODIPINEEXTENDED-RELEASE TABLETS felodipine TABLET, EXTENDED RELEASE ORAL 20080910 NDA NDA019834 Ranbaxy Pharmaceuticals Inc FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63304-436_b951455c-c235-4e23-9e21-08672d108726 63304-436 HUMAN PRESCRIPTION DRUG FELODIPINEEXTENDED-RELEASE TABLETS felodipine TABLET, EXTENDED RELEASE ORAL 20080910 NDA NDA019834 Ranbaxy Pharmaceuticals Inc FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63304-437_b951455c-c235-4e23-9e21-08672d108726 63304-437 HUMAN PRESCRIPTION DRUG FELODIPINEEXTENDED-RELEASE TABLETS felodipine TABLET, EXTENDED RELEASE ORAL 20080910 NDA NDA019834 Ranbaxy Pharmaceuticals Inc FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63304-445_b43f6b44-9de3-4efb-a467-487aee28f6a0 63304-445 HUMAN PRESCRIPTION DRUG Omeprazole Delayed-Release Omeprazole CAPSULE, DELAYED RELEASE ORAL 20080725 NDA NDA019810 Ranbaxy Laboratories Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 63304-450_111f3a79-141c-4c16-94b1-b5bc51966c01 63304-450 HUMAN PRESCRIPTION DRUG Morphine sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120511 ANDA ANDA078761 Ranbaxy Pharmaceuticals Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63304-451_111f3a79-141c-4c16-94b1-b5bc51966c01 63304-451 HUMAN PRESCRIPTION DRUG Morphine sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120511 ANDA ANDA078761 Ranbaxy Pharmaceuticals Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63304-452_111f3a79-141c-4c16-94b1-b5bc51966c01 63304-452 HUMAN PRESCRIPTION DRUG Morphine sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120511 ANDA ANDA078761 Ranbaxy Pharmaceuticals Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63304-453_111f3a79-141c-4c16-94b1-b5bc51966c01 63304-453 HUMAN PRESCRIPTION DRUG Morphine sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120511 ANDA ANDA078761 Ranbaxy Pharmaceuticals Inc. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63304-458_834bc56a-657d-4733-9a60-47040cb5c7bf 63304-458 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Ranbaxy Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63304-459_834bc56a-657d-4733-9a60-47040cb5c7bf 63304-459 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Ranbaxy Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63304-460_cfca0747-ed49-447d-be28-98c231a5c80d 63304-460 HUMAN PRESCRIPTION DRUG Chloroquine phosphate Chloroquine phosphate TABLET, FILM COATED ORAL 20110315 ANDA ANDA090610 Ranbaxy Pharmaceuticals Inc. CHLOROQUINE PHOSPHATE 250 mg/1 Antimalarial [EPC] 63304-461_78f66195-aad3-4abf-bcec-7ad609fbefa7 63304-461 HUMAN PRESCRIPTION DRUG Chloroquine Phosphate Chloroquine Phosphate TABLET, FILM COATED ORAL 20110315 ANDA ANDA090249 Ranbaxy Pharmaceuticals Inc. CHLOROQUINE PHOSPHATE 500 mg/1 Antimalarial [EPC] 63304-479_ba4192d1-7b35-4b71-991e-0019a6b8aa0f 63304-479 HUMAN PRESCRIPTION DRUG Cevimeline Cevimeline CAPSULE ORAL 20121007 NDA NDA020989 Ranbaxy Pharmaceuticals Inc. CEVIMELINE HYDROCHLORIDE 30 mg/1 Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 63304-497_458ad507-a066-4079-af1a-53799037dc51 63304-497 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20070816 ANDA ANDA040826 Ranbaxy Pharmaceuticals Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63304-499_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-499 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-500_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-500 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-501_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-501 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-502_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-502 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-503_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-503 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-504_7a18c7e7-b635-439a-8f8b-8dac5704fba6 63304-504 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 19990208 ANDA ANDA074980 Ranbaxy Laboratories Ltd. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63304-505_7a18c7e7-b635-439a-8f8b-8dac5704fba6 63304-505 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 19990208 ANDA ANDA074980 Ranbaxy Laboratories Ltd. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63304-531_a310a726-8130-4366-baaf-94874f353b0a 63304-531 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020702 ANDA ANDA075944 Ranbaxy Pharmaceuticals Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63304-532_a310a726-8130-4366-baaf-94874f353b0a 63304-532 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020702 ANDA ANDA075944 Ranbaxy Pharmaceuticals Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63304-533_a310a726-8130-4366-baaf-94874f353b0a 63304-533 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020702 ANDA ANDA075944 Ranbaxy Pharmaceuticals Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63304-534_a310a726-8130-4366-baaf-94874f353b0a 63304-534 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020702 ANDA ANDA075944 Ranbaxy Pharmaceuticals Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63304-535_a310a726-8130-4366-baaf-94874f353b0a 63304-535 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020702 ANDA ANDA075944 Ranbaxy Pharmaceuticals Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63304-536_b119c7cd-d261-41ca-94a4-d01ace9e4929 63304-536 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20020702 ANDA ANDA076007 Ranbaxy Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63304-537_b119c7cd-d261-41ca-94a4-d01ace9e4929 63304-537 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20020702 ANDA ANDA076007 Ranbaxy Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63304-538_b119c7cd-d261-41ca-94a4-d01ace9e4929 63304-538 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20020702 ANDA ANDA076007 Ranbaxy Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63304-539_205867ab-d40a-4f09-8338-4509e576ac95 63304-539 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20110606 ANDA ANDA090637 Ranbaxy Pharmaceuticals Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 63304-540_205867ab-d40a-4f09-8338-4509e576ac95 63304-540 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20110606 ANDA ANDA090637 Ranbaxy Pharmaceuticals Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 63304-548_113bf082-5410-4cad-8468-d0e52f1b0676 63304-548 HUMAN PRESCRIPTION DRUG Quinapril quinapril TABLET, FILM COATED ORAL 20070924 ANDA ANDA076607 Ranbaxy Pharmaceuticals Inc. QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63304-549_113bf082-5410-4cad-8468-d0e52f1b0676 63304-549 HUMAN PRESCRIPTION DRUG Quinapril quinapril TABLET, FILM COATED ORAL 20070924 ANDA ANDA076607 Ranbaxy Pharmaceuticals Inc. QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63304-550_113bf082-5410-4cad-8468-d0e52f1b0676 63304-550 HUMAN PRESCRIPTION DRUG Quinapril quinapril TABLET, FILM COATED ORAL 20070924 ANDA ANDA076607 Ranbaxy Pharmaceuticals Inc. QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63304-551_113bf082-5410-4cad-8468-d0e52f1b0676 63304-551 HUMAN PRESCRIPTION DRUG Quinapril quinapril TABLET, FILM COATED ORAL 20070924 ANDA ANDA076607 Ranbaxy Pharmaceuticals Inc. QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63304-552_9288b398-2811-4f9b-a088-c719de4dc8f4 63304-552 HUMAN PRESCRIPTION DRUG Clorazepate dipotassium Clorazepate dipotassium TABLET ORAL 20050114 ANDA ANDA076911 Ranbaxy Pharmaceuticals Inc. CLORAZEPATE DIPOTASSIUM 3.75 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63304-553_9288b398-2811-4f9b-a088-c719de4dc8f4 63304-553 HUMAN PRESCRIPTION DRUG Clorazepate dipotassium Clorazepate dipotassium TABLET ORAL 20050114 ANDA ANDA076911 Ranbaxy Pharmaceuticals Inc. CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63304-554_9288b398-2811-4f9b-a088-c719de4dc8f4 63304-554 HUMAN PRESCRIPTION DRUG Clorazepate dipotassium Clorazepate dipotassium TABLET ORAL 20050114 ANDA ANDA076911 Ranbaxy Pharmaceuticals Inc. CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63304-561_11db3014-3e76-45ed-ba89-9a56cbd3c919 63304-561 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19800123 ANDA ANDA087083 Ranbaxy Pharmaceuticals Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 63304-562_11db3014-3e76-45ed-ba89-9a56cbd3c919 63304-562 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19781116 ANDA ANDA085868 Ranbaxy Pharmaceuticals Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 63304-579_80c4c66e-f913-4026-854e-f37b35ebf70c 63304-579 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090324 ANDA ANDA078459 Ranbaxy Pharmaceuticals Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63304-580_80c4c66e-f913-4026-854e-f37b35ebf70c 63304-580 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090315 ANDA ANDA078459 Ranbaxy Pharmaceuticals Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63304-581_80c4c66e-f913-4026-854e-f37b35ebf70c 63304-581 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090315 ANDA ANDA078459 Ranbaxy Pharmaceuticals Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63304-587_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-587 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-588_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-588 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-589_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-589 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-590_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-590 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-591_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-591 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-599_a310a726-8130-4366-baaf-94874f353b0a 63304-599 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060515 ANDA ANDA075944 Ranbaxy Pharmaceuticals Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63304-603_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-603 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-614_66d37abb-3581-45ad-a902-470079c4a608 63304-614 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20001226 ANDA ANDA065053 Ranbaxy Pharmaceuticals Inc. DOXYCYCLINE 50 mg/1 63304-615_66d37abb-3581-45ad-a902-470079c4a608 63304-615 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20001226 ANDA ANDA065053 Ranbaxy Pharmaceuticals Inc. DOXYCYCLINE 75 mg/1 63304-616_66d37abb-3581-45ad-a902-470079c4a608 63304-616 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20001226 ANDA ANDA065053 Ranbaxy Pharmaceuticals Inc. DOXYCYCLINE 100 mg/1 63304-621_73fb01d6-5dd9-485a-ac30-59c176b2c095 63304-621 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Ranbaxy Pharmaceuticals Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63304-622_73fb01d6-5dd9-485a-ac30-59c176b2c095 63304-622 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Ranbaxy Pharmaceuticals Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63304-623_73fb01d6-5dd9-485a-ac30-59c176b2c095 63304-623 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Ranbaxy Pharmaceuticals Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63304-624_71ce103c-23d0-47fe-b2e0-4249618ab8ed 63304-624 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Ranbaxy Pharmaceuticals Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63304-625_71ce103c-23d0-47fe-b2e0-4249618ab8ed 63304-625 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Ranbaxy Pharmaceuticals Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63304-626_71ce103c-23d0-47fe-b2e0-4249618ab8ed 63304-626 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Ranbaxy Pharmaceuticals Inc. FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63304-627_3ac31363-4eb4-4333-ba7f-fc2db7b42439 63304-627 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20051102 ANDA ANDA076606 Ranbaxy Pharmaceuticals Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63304-628_3ac31363-4eb4-4333-ba7f-fc2db7b42439 63304-628 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20051102 ANDA ANDA076606 Ranbaxy Pharmaceuticals Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63304-629_3ac31363-4eb4-4333-ba7f-fc2db7b42439 63304-629 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20051102 ANDA ANDA076606 Ranbaxy Pharmaceuticals Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63304-632_c376ceaf-1525-49a6-9b9d-f1115f146a33 63304-632 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine CAPSULE ORAL 20050720 ANDA ANDA076990 Ranbaxy Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63304-636_3406db8a-5ae9-4120-94bd-036701adbeca 63304-636 HUMAN PRESCRIPTION DRUG GANCICLOVIR GANCICLOVIR CAPSULE ORAL 20030827 ANDA ANDA076457 Ranbaxy Pharmaceuticals Inc. GANCICLOVIR 250 mg/1 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 63304-637_3406db8a-5ae9-4120-94bd-036701adbeca 63304-637 HUMAN PRESCRIPTION DRUG GANCICLOVIR GANCICLOVIR CAPSULE ORAL 20030827 ANDA ANDA076457 Ranbaxy Pharmaceuticals Inc. GANCICLOVIR 500 mg/1 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 63304-643_a39eb097-ad34-43ed-b6df-a5e4b7d7eee9 63304-643 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100806 ANDA ANDA078474 Ranbaxy Pharmaceuticals Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 63304-644_a39eb097-ad34-43ed-b6df-a5e4b7d7eee9 63304-644 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100806 ANDA ANDA078474 Ranbaxy Pharmaceuticals Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 63304-652_7a18c7e7-b635-439a-8f8b-8dac5704fba6 63304-652 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir CAPSULE ORAL 19990208 ANDA ANDA074975 Ranbaxy Laboratories Ltd. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63304-653_2719255f-6d1f-4f01-83b4-04c9dec58eac 63304-653 HUMAN PRESCRIPTION DRUG Oxcarbazepine oxcarbazepine SUSPENSION ORAL 20091214 ANDA ANDA078734 Ranbaxy Pharmaceuticals Inc. OXCARBAZEPINE 60 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63304-692_45b05bbf-b11a-4431-97b8-4137c683f39e 63304-692 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Ranbaxy Pharmaceuticals Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 63304-693_45b05bbf-b11a-4431-97b8-4137c683f39e 63304-693 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Ranbaxy Pharmaceuticals Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 63304-694_1ffca7b6-8f19-4a26-9578-cbdd72296068 63304-694 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Ranbaxy Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 63304-695_1ffca7b6-8f19-4a26-9578-cbdd72296068 63304-695 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Ranbaxy Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 63304-696_1ffca7b6-8f19-4a26-9578-cbdd72296068 63304-696 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Ranbaxy Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 63304-697_4a8d201f-b0b6-4463-af35-8f241caf048b 63304-697 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED ORAL 20040629 ANDA ANDA065156 Ranbaxy Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 63304-698_4a8d201f-b0b6-4463-af35-8f241caf048b 63304-698 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED ORAL 20040629 ANDA ANDA065156 Ranbaxy Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 63304-699_4a8d201f-b0b6-4463-af35-8f241caf048b 63304-699 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED ORAL 20040629 ANDA ANDA065156 Ranbaxy Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 63304-709_aa0b6a4a-f8ff-4d09-8813-2d58192c08c5 63304-709 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075747 Ranbaxy Pharmaceuticals Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 63304-710_aa0b6a4a-f8ff-4d09-8813-2d58192c08c5 63304-710 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075747 Ranbaxy Pharmaceuticals Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 63304-711_aa0b6a4a-f8ff-4d09-8813-2d58192c08c5 63304-711 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075747 Ranbaxy Pharmaceuticals Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 63304-725_1cf704dd-e3e3-4ae6-9b3e-f67116212adc 63304-725 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20050525 ANDA ANDA065174 Ranbaxy Pharmaceuticals Inc. CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 63304-726_1cf704dd-e3e3-4ae6-9b3e-f67116212adc 63304-726 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20050525 ANDA ANDA065174 Ranbaxy Pharmaceuticals Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 63304-736_7e00d1b7-7298-4100-b40a-585dfbce5c3c 63304-736 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076344 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63304-737_7e00d1b7-7298-4100-b40a-585dfbce5c3c 63304-737 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076344 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63304-738_7e00d1b7-7298-4100-b40a-585dfbce5c3c 63304-738 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076344 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63304-739_7e00d1b7-7298-4100-b40a-585dfbce5c3c 63304-739 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076344 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63304-758_111f3a79-141c-4c16-94b1-b5bc51966c01 63304-758 HUMAN PRESCRIPTION DRUG Morphine sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120511 ANDA ANDA078761 Ranbaxy Pharmaceuticals Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63304-768_de18b1f7-d919-47b1-8bab-eff03ca5ea8f 63304-768 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium SUSPENSION ORAL 20070313 ANDA ANDA065207 Ranbaxy Pharmaceuticals Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 63304-772_ff52848c-6705-4ef1-bb6e-fce0e78b9a69 63304-772 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20011211 ANDA ANDA076045 Ranbaxy Pharmaceuticals Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63304-773_ff52848c-6705-4ef1-bb6e-fce0e78b9a69 63304-773 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20011211 ANDA ANDA076045 Ranbaxy Pharmaceuticals Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63304-774_ff52848c-6705-4ef1-bb6e-fce0e78b9a69 63304-774 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20011211 ANDA ANDA076045 Ranbaxy Pharmaceuticals Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63304-778_831ec733-ecc5-4461-a462-0dbc11811df1 63304-778 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20100104 ANDA ANDA076327 Ranbaxy Pharmaceuticals Inc TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63304-779_831ec733-ecc5-4461-a462-0dbc11811df1 63304-779 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20100104 ANDA ANDA076327 Ranbaxy Pharmaceuticals Inc TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63304-780_831ec733-ecc5-4461-a462-0dbc11811df1 63304-780 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20100104 ANDA ANDA076327 Ranbaxy Pharmaceuticals Inc TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63304-789_d005a31b-31ba-400e-a75c-99e6adf745bd 63304-789 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA076285 Ranbaxy Pharmaceuticals Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-790_d005a31b-31ba-400e-a75c-99e6adf745bd 63304-790 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA076285 Ranbaxy Pharmaceuticals Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-791_d005a31b-31ba-400e-a75c-99e6adf745bd 63304-791 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA076285 Ranbaxy Pharmaceuticals Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-792_d005a31b-31ba-400e-a75c-99e6adf745bd 63304-792 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA076285 Ranbaxy Pharmaceuticals Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-793_d005a31b-31ba-400e-a75c-99e6adf745bd 63304-793 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA076285 Ranbaxy Pharmaceuticals Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-794_f13a72ef-8d6e-42e8-985e-d31ec9c07525 63304-794 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide TABLET ORAL 20040228 ANDA ANDA076421 Ranbaxy Pharmaceuticals Inc. FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] 63304-795_f13a72ef-8d6e-42e8-985e-d31ec9c07525 63304-795 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide TABLET ORAL 20040228 ANDA ANDA076421 Ranbaxy Pharmaceuticals Inc. FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] 63304-796_f13a72ef-8d6e-42e8-985e-d31ec9c07525 63304-796 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide TABLET ORAL 20040228 ANDA ANDA076421 Ranbaxy Pharmaceuticals Inc. FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] 63304-821_1cf704dd-e3e3-4ae6-9b3e-f67116212adc 63304-821 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin GRANULE, FOR SUSPENSION ORAL 20071003 ANDA ANDA065382 Ranbaxy Pharmaceuticals Inc. CLARITHROMYCIN 125 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 63304-822_1cf704dd-e3e3-4ae6-9b3e-f67116212adc 63304-822 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin GRANULE, FOR SUSPENSION ORAL 20071003 ANDA ANDA065382 Ranbaxy Pharmaceuticals Inc. CLARITHROMYCIN 250 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 63304-827_66c4e9c7-4bc1-45c1-80ac-6487e6979ff7 63304-827 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Ranbaxy Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-828_66c4e9c7-4bc1-45c1-80ac-6487e6979ff7 63304-828 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Ranbaxy Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-829_66c4e9c7-4bc1-45c1-80ac-6487e6979ff7 63304-829 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Ranbaxy Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-830_66c4e9c7-4bc1-45c1-80ac-6487e6979ff7 63304-830 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Ranbaxy Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63304-845_38615cef-95ad-4574-b433-422037e5658d 63304-845 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20090313 ANDA ANDA078807 Ranbaxy Pharmaceuticals Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 63304-846_38615cef-95ad-4574-b433-422037e5658d 63304-846 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20090313 ANDA ANDA078807 Ranbaxy Pharmaceuticals Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 63304-873_10c6e4c9-4ad8-404a-a084-c4cb720ff7e1 63304-873 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070709 ANDA ANDA077974 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63304-874_10c6e4c9-4ad8-404a-a084-c4cb720ff7e1 63304-874 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070709 ANDA ANDA077974 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63304-875_10c6e4c9-4ad8-404a-a084-c4cb720ff7e1 63304-875 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070709 ANDA ANDA077974 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63304-900_3811e946-7f9a-4e2f-8d94-3a486aaae304 63304-900 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20060510 ANDA ANDA076635 Ranbaxy Pharmaceuticals Inc. FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 63304-901_3811e946-7f9a-4e2f-8d94-3a486aaae304 63304-901 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20060510 ANDA ANDA076635 Ranbaxy Pharmaceuticals Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 63304-904_ba7172b3-5f95-4ee1-bc30-a597fca364d4 63304-904 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20070131 ANDA ANDA076588 Ranbaxy Pharmaceuticals Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63304-905_ba7172b3-5f95-4ee1-bc30-a597fca364d4 63304-905 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20070131 ANDA ANDA076588 Ranbaxy Pharmaceuticals Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63304-949_a39eb097-ad34-43ed-b6df-a5e4b7d7eee9 63304-949 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100806 ANDA ANDA077542 Ranbaxy Pharmaceuticals Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 63304-950_a39eb097-ad34-43ed-b6df-a5e4b7d7eee9 63304-950 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100806 ANDA ANDA077542 Ranbaxy Pharmaceuticals Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 63304-951_a39eb097-ad34-43ed-b6df-a5e4b7d7eee9 63304-951 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100806 ANDA ANDA077542 Ranbaxy Pharmaceuticals Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 63304-958_6db14b9b-5e94-4cd5-9d7b-cdf97d383648 63304-958 HUMAN PRESCRIPTION DRUG CEPHALEXIN CEPHALEXIN SUSPENSION ORAL 20011029 ANDA ANDA065081 Ranbaxy Pharmaceuticals Inc. CEPHALEXIN 125 mg/5mL 63304-959_6db14b9b-5e94-4cd5-9d7b-cdf97d383648 63304-959 HUMAN PRESCRIPTION DRUG CEPHALEXIN CEPHALEXIN SUSPENSION ORAL 20011029 ANDA ANDA065081 Ranbaxy Pharmaceuticals Inc. CEPHALEXIN 250 mg/5mL 63304-963_037e5290-f39e-45ef-a05c-51b0ce2c4473 63304-963 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil For Oral Suspension Cefuroxime Axetil SUSPENSION ORAL 20080208 ANDA ANDA065323 Ranbaxy Pharmaceuticals Inc CEFUROXIME AXETIL 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63304-964_037e5290-f39e-45ef-a05c-51b0ce2c4473 63304-964 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil For Oral Suspension Cefuroxime Axetil SUSPENSION ORAL 20080208 ANDA ANDA065323 Ranbaxy Pharmaceuticals Inc CEFUROXIME AXETIL 250 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63304-972_a95b07d7-65c1-438d-91e0-0eaca684eccf 63304-972 HUMAN PRESCRIPTION DRUG CEFADROXIL cefadroxil monohydrate POWDER, FOR SUSPENSION ORAL 20050830 ANDA ANDA065115 Ranbaxy Pharmaceuticals Inc. CEFADROXIL 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63304-973_a95b07d7-65c1-438d-91e0-0eaca684eccf 63304-973 HUMAN PRESCRIPTION DRUG CEFADROXIL cefadroxil monohydrate POWDER, FOR SUSPENSION ORAL 20050830 ANDA ANDA065115 Ranbaxy Pharmaceuticals Inc. CEFADROXIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63304-974_a95b07d7-65c1-438d-91e0-0eaca684eccf 63304-974 HUMAN PRESCRIPTION DRUG CEFADROXIL cefadroxil monohydrate POWDER, FOR SUSPENSION ORAL 20050830 ANDA ANDA065115 Ranbaxy Pharmaceuticals Inc. CEFADROXIL 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-006_eec49271-9a00-43cb-b949-393ce1ee462c 63323-006 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20000810 UNAPPROVED DRUG OTHER Fresenius Kabi USA, LLC SODIUM BICARBONATE 84 mg/mL 63323-010_26026202-e55b-4f1d-a07e-f4cf03fc5c77 63323-010 HUMAN PRESCRIPTION DRUG Gentamicin GENTAMICIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000810 ANDA ANDA062366 Fresenius Kabi USA, LLC GENTAMICIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 63323-010_ef7158be-5768-4cbf-85ae-7fdee2b58300 63323-010 HUMAN PRESCRIPTION DRUG Gentamicin GENTAMICIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000810 ANDA ANDA062366 Fresenius Kabi USA, LLC GENTAMICIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 63323-010_fecd2ff0-bf01-4a4d-9f0c-ab6e28e907c8 63323-010 HUMAN PRESCRIPTION DRUG Gentamicin GENTAMICIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000810 ANDA ANDA062366 Fresenius Kabi USA, LLC GENTAMICIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 63323-011_aacc4296-f0b6-4d49-993f-8adbbe53557a 63323-011 HUMAN PRESCRIPTION DRUG Chloramphenicol Sodium Succinate CHLORAMPHENICOL SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010112 ANDA ANDA062365 APP Pharmaceuticals, LLC CHLORAMPHENICOL SODIUM SUCCINATE 1 g/10mL Amphenicol-class Antibacterial [EPC],Amphenicols [Chemical/Ingredient] 63323-012_22cb8823-f453-4469-911e-49e3c92e99ef 63323-012 HUMAN PRESCRIPTION DRUG Oxytocin OXYTOCIN INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000810 NDA NDA018248 APP Pharmaceuticals, LLC OXYTOCIN 10 [USP'U]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 63323-012_5485f878-e591-45c5-961b-a9d434769f99 63323-012 HUMAN PRESCRIPTION DRUG Oxytocin OXYTOCIN INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000810 NDA NDA018248 Fresenius Kabi USA, LLC OXYTOCIN 10 [USP'U]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] 63323-013_6fbc944c-5ad5-4794-8908-653c304354a9 63323-013 HUMAN PRESCRIPTION DRUG Thiamine THIAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000901 ANDA ANDA080556 Fresenius Kabi USA, LLC THIAMINE HYDROCHLORIDE 100 mg/mL 63323-013_e92d9b8d-9d56-463f-be10-198fc7978a48 63323-013 HUMAN PRESCRIPTION DRUG Thiamine THIAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000901 ANDA ANDA080556 Fresenius Kabi USA, LLC THIAMINE HYDROCHLORIDE 100 mg/mL 63323-019_ff54b240-853e-4fb6-9b9e-b52404f5f9eb 63323-019 HUMAN PRESCRIPTION DRUG Iodopen Sodium Iodide SODIUM IODIDE INJECTION, SOLUTION INTRAVENOUS 20010718 UNAPPROVED DRUG OTHER APP Pharmaceuticals, LLC SODIUM IODIDE 118 ug/mL 63323-024_0ca6888f-1467-4956-b3a7-12454a6cdbb4 63323-024 HUMAN PRESCRIPTION DRUG Mannitol MANNITOL INJECTION, SOLUTION INTRAVENOUS 20000319 ANDA ANDA080677 Fresenius Kabi USA, LLC MANNITOL 250 mg/mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 63323-024_b6d16e55-2df8-43ca-a504-aca761561d43 63323-024 HUMAN PRESCRIPTION DRUG Mannitol MANNITOL INJECTION, SOLUTION INTRAVENOUS 20000319 ANDA ANDA080677 Fresenius Kabi USA, LLC MANNITOL 250 mg/mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] 63323-025_569c6ba5-9a67-4a8c-bf8d-e34f3c473ffd 63323-025 HUMAN PRESCRIPTION DRUG Chorionic Gonadotropin CHORIOGONADOTROPIN ALFA KIT INTRAMUSCULAR 20110421 NDA NDA017067 APP Pharmaceuticals, LLC 63323-026_c1f99423-2666-4330-9c33-2442402dd6ef 63323-026 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE SOLUTION INTRAVENOUS 20000810 UNAPPROVED DRUG OTHER APP Pharmaceuticals, LLC SODIUM BICARBONATE 42 mg/mL 63323-032_9d85c8fe-57f4-4400-b8e3-c66a2826d847 63323-032 HUMAN PRESCRIPTION DRUG Sodium Acetate SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20000901 UNAPPROVED DRUG OTHER APP Pharmaceuticals, LLC SODIUM ACETATE 328 mg/100mL 63323-044_c024db96-e526-4558-803c-8c22890048d4 63323-044 HUMAN PRESCRIPTION DRUG Cyanocobalamin CYANOCOBALAMIN INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20001018 ANDA ANDA080557 APP Pharmaceuticals, LLC CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 63323-047_3bbce5c9-3dd0-4675-9a87-a2d786b435e6 63323-047 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017651 Fresenius Kabi USA, LLC HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63323-064_24d1e599-c3af-4823-b7e5-564b5872a563 63323-064 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000808 NDA NDA019316 Fresenius Kabi USA, LLC MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 63323-064_2e28abc1-5a5c-4347-9f0e-7bb644351606 63323-064 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000808 NDA NDA019316 Fresenius Kabi USA, LLC MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 63323-064_553a2249-cd8b-438a-862e-ff1560f2b51f 63323-064 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000808 UNAPPROVED DRUG OTHER Fresenius Kabi USA, LLC MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 63323-064_d89e4696-9515-4a3b-b0d4-7677ad65d018 63323-064 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000808 UNAPPROVED DRUG OTHER Fresenius Kabi USA, LLC MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 63323-086_3d39f2fc-640b-468e-88d7-b9e8f7ae27d4 63323-086 HUMAN PRESCRIPTION DRUG Potassium Phosphates POTASSIUM PHOSPHATE, MONOBASIC and POTASSIUM PHOSPHATE, DIBASIC INJECTION, SOLUTION INTRAVENOUS 20000808 UNAPPROVED DRUG OTHER Fresenius Kabi USA, LLC POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 236; 224 mg/mL; mg/mL 63323-088_0e109cad-c244-4a63-9c63-ccc7cd6815df 63323-088 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20010112 UNAPPROVED DRUG OTHER APP Pharmaceuticals, LLC SODIUM CHLORIDE 234 mg/mL 63323-101_dd1cc92f-6089-407e-b0de-49316a3221c6 63323-101 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20000614 ANDA ANDA063277 Fresenius Kabi USA, LLC DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 63323-102_1f6640a8-b2c5-4880-88a3-ff5593fef17a 63323-102 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110912 ANDA ANDA077983 APP Pharmaceuticals, LLC GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 63323-102_7a2275c5-285c-4c2a-8fdc-159353f3d287 63323-102 HUMAN PRESCRIPTION DRUG GEMCITABINE HYDROCHLORIDE GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110726 ANDA ANDA090799 APP Pharmaceuticals, LLC GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 63323-103_b4c79396-7cbf-44db-9ec6-c72b4b380443 63323-103 HUMAN PRESCRIPTION DRUG Cisplatin CISPLATIN INJECTION, SOLUTION INTRAVENOUS 20000905 ANDA ANDA074735 Fresenius Kabi USA, LLC CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 63323-104_f950cc1e-3a2e-4caf-9cc5-6b3579193d82 63323-104 HUMAN PRESCRIPTION DRUG Etoposide ETOPOSIDE INJECTION, SOLUTION INTRAVENOUS 20010718 ANDA ANDA074983 APP Pharmaceuticals, LLC ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 63323-105_cebdc1fd-5d8e-4c3e-8d41-baa4d28b981f 63323-105 HUMAN PRESCRIPTION DRUG Acyclovir ACYCLOVIR SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20001017 ANDA ANDA075015 APP Pharmaceuticals, LLC ACYCLOVIR SODIUM 50 mg/mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63323-113_2cd3bffe-b3ad-4a79-b782-6880ee48afb0 63323-113 HUMAN PRESCRIPTION DRUG Pentam 300 PENTAMIDINE ISETHIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010116 NDA NDA019264 APP Pharmaceuticals, LLC PENTAMIDINE ISETHIONATE 300 mg/3mL Antiprotozoal [EPC] 63323-117_08d76455-44fc-48f6-8b78-ddf0f08cc758 63323-117 HUMAN PRESCRIPTION DRUG Fluorouracil FLUOROURACIL INJECTION, SOLUTION INTRAVENOUS 20000712 ANDA ANDA040279 Fresenius Kabi USA, LLC FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 63323-117_226abe82-ef60-48f9-b200-1be737ddb2f9 63323-117 HUMAN PRESCRIPTION DRUG Fluorouracil FLUOROURACIL INJECTION, SOLUTION INTRAVENOUS 20000712 ANDA ANDA040279 Fresenius Kabi USA, LLC FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 63323-117_357ef2e4-f1bb-4b00-90bf-205868e0eb2f 63323-117 HUMAN PRESCRIPTION DRUG Fluorouracil FLUOROURACIL INJECTION, SOLUTION INTRAVENOUS 20000712 ANDA ANDA040278 Fresenius Kabi USA, LLC FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 63323-117_59e16df7-a994-402f-92b6-57c926a20678 63323-117 HUMAN PRESCRIPTION DRUG Fluorouracil FLUOROURACIL INJECTION, SOLUTION INTRAVENOUS 20000712 ANDA ANDA040278 Fresenius Kabi USA, LLC FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 63323-117_8694989c-3602-4642-87e0-19cc9a5e312a 63323-117 HUMAN PRESCRIPTION DRUG Fluorouracil FLUOROURACIL INJECTION, SOLUTION INTRAVENOUS 20000712 ANDA ANDA040279 Fresenius Kabi USA, LLC FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 63323-117_8d70a44c-7959-442d-b8d6-7f11bbd73f20 63323-117 HUMAN PRESCRIPTION DRUG Fluorouracil FLUOROURACIL INJECTION, SOLUTION INTRAVENOUS 20000712 ANDA ANDA040278 Fresenius Kabi USA, LLC FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 63323-120_01e29639-16f7-4f0b-a27c-1e17a4a8184f 63323-120 HUMAN PRESCRIPTION DRUG Cytarabine CYTARABINE INJECTION, SOLUTION INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS 20041129 ANDA ANDA076512 APP Pharmaceuticals, LLC CYTARABINE 100 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 63323-122_5c7e2919-468d-457f-bbf9-e31c89070a81 63323-122 HUMAN PRESCRIPTION DRUG Methotrexate METHOTREXATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20000122 ANDA ANDA040266 Fresenius Kabi USA, LLC METHOTREXATE SODIUM 1 g/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 63323-122_a1b64513-3666-4425-96f6-52058bcc0585 63323-122 HUMAN PRESCRIPTION DRUG Methotrexate METHOTREXATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20000122 ANDA ANDA040266 Fresenius Kabi USA, LLC METHOTREXATE SODIUM 1 g/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 63323-123_313cbcb0-8c52-4451-bebb-e33b486f1702 63323-123 HUMAN PRESCRIPTION DRUG Methotrexate METHOTREXATE SODIUM INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRAVENOUS 20010910 ANDA ANDA040263 Fresenius Kabi USA, LLC METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 63323-125_1f6640a8-b2c5-4880-88a3-ff5593fef17a 63323-125 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110912 ANDA ANDA077983 APP Pharmaceuticals, LLC GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 63323-125_7a2275c5-285c-4c2a-8fdc-159353f3d287 63323-125 HUMAN PRESCRIPTION DRUG GEMCITABINE HYDROCHLORIDE GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110726 ANDA ANDA090799 APP Pharmaceuticals, LLC GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 63323-126_7a2275c5-285c-4c2a-8fdc-159353f3d287 63323-126 HUMAN PRESCRIPTION DRUG GEMCITABINE HYDROCHLORIDE GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110516 ANDA ANDA090799 APP Pharmaceuticals, LLC GEMCITABINE HYDROCHLORIDE 2 g/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 63323-127_cee49be4-a9e3-4f9f-852e-a3d3b25ac44f 63323-127 HUMAN PRESCRIPTION DRUG Dacarbazine DACARBAZINE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20010907 ANDA ANDA075371 APP Pharmaceuticals, LLC DACARBAZINE 10 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] 63323-128_cee49be4-a9e3-4f9f-852e-a3d3b25ac44f 63323-128 HUMAN PRESCRIPTION DRUG Dacarbazine DACARBAZINE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20010907 ANDA ANDA075371 APP Pharmaceuticals, LLC DACARBAZINE 10 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] 63323-129_2c825cab-6f6a-4488-90c8-fed70cd6e4b5 63323-129 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100628 ANDA ANDA090088 APP Pharmaceuticals, LLC ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 63323-130_3882c86e-0ce0-49a2-ad8f-a022eb115ea0 63323-130 HUMAN PRESCRIPTION DRUG Doxy 100 DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20001017 ANDA ANDA062475 Fresenius Kabi USA, LLC DOXYCYCLINE HYCLATE 100 mg/10mL 63323-130_722e6a76-c1b3-4f5f-abb4-75dd055ffda0 63323-130 HUMAN PRESCRIPTION DRUG Doxy 100 DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20001017 ANDA ANDA062475 Fresenius Kabi USA, LLC DOXYCYCLINE HYCLATE 100 mg/10mL 63323-130_c3d6f8c4-e275-460a-911c-01038578d00d 63323-130 HUMAN PRESCRIPTION DRUG Doxy 100 DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20001017 ANDA ANDA062475 Fresenius Kabi USA, LLC DOXYCYCLINE HYCLATE 100 mg/10mL 63323-132_b7e34eb1-5007-4085-a6da-0e6f5c02f93f 63323-132 HUMAN PRESCRIPTION DRUG Mitoxantrone MITOXANTRONE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20060411 ANDA ANDA077496 Fresenius Kabi USA, LLC MITOXANTRONE HYDROCHLORIDE 2 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 63323-136_6c5dc0c6-4394-4799-85e7-dd7674806683 63323-136 HUMAN PRESCRIPTION DRUG Bleomycin BLEOMYCIN SULFATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS 20090213 ANDA ANDA065185 Fresenius Kabi USA, LLC BLEOMYCIN SULFATE 15 [USP&apos'U]/1 Cytoprotective Agent [EPC] 63323-137_6c5dc0c6-4394-4799-85e7-dd7674806683 63323-137 HUMAN PRESCRIPTION DRUG Bleomycin BLEOMYCIN SULFATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS 20090213 ANDA ANDA065185 Fresenius Kabi USA, LLC BLEOMYCIN SULFATE 30 [USP&apos'U]/1 Cytoprotective Agent [EPC] 63323-139_08ade467-50c0-4b23-9f39-3fe6333c9e8d 63323-139 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20000906 UNAPPROVED DRUG OTHER APP Pharmaceuticals, LLC SODIUM CHLORIDE 146 mg/mL 63323-140_512212cd-c261-48d1-8cf9-2cf86c9e3ea0 63323-140 HUMAN PRESCRIPTION DRUG Cladribine CLADRIBINE INJECTION INTRAVENOUS 20041201 ANDA ANDA076571 Fresenius Kabi USA, LLC CLADRIBINE 1 mg/mL Purine Antimetabolite [EPC] 63323-142_85229bdc-0428-4299-b0bc-c9b6576e349f 63323-142 HUMAN PRESCRIPTION DRUG Ifosfamide IFOSFAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20030128 ANDA ANDA076078 APP Pharmaceuticals, LLC IFOSFAMIDE 1 g/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 63323-142_de0e15b3-bd24-4cfa-9309-2e7bb7ee705d 63323-142 HUMAN PRESCRIPTION DRUG Ifosfamide IFOSFAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20030128 ANDA ANDA076078 Fresenius Kabi USA, LLC IFOSFAMIDE 1 g/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 63323-143_3678a067-c132-4bed-b232-0b7448242120 63323-143 HUMAN PRESCRIPTION DRUG Addamel N CHROMIUM, COPPER, IRON, MANGANESE, IODINE, FLUORINE, MOLYBDENUM, SELENIUM, and ZINC INJECTION, SOLUTION INTRAVENOUS 20130507 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Fresenius Kabi USA, LLC CHROMIC CHLORIDE; CUPROUS CHLORIDE; FERRIC CHLORIDE; MANGANESE CHLORIDE; POTASSIUM IODIDE; SODIUM FLUORIDE; SODIUM MOLYBDATE DIHYDRATE; SODIUM SELENITE; ZINC CHLORIDE 1; .13; .11; .027; .013; .095; 1.9; 3.2; .65 ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; ug/mL; mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 63323-145_957bd9ea-2646-41d2-bdbd-7ff46f435c4b 63323-145 HUMAN PRESCRIPTION DRUG Floxuridine FLOXURIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRA-ARTERIAL 20010315 ANDA ANDA075837 APP Pharmaceuticals, LLC FLOXURIDINE 500 mg/5mL Antimetabolite [EPC],Deoxyuridine [Chemical/Ingredient] 63323-147_086089e9-b92a-4cd3-9df4-39fbd4ee4704 63323-147 HUMAN PRESCRIPTION DRUG Peditrace ZINC, COPPER, MANGANESE, SELENIUM, FLUORINE, and IODINE INJECTION, SOLUTION INTRAVENOUS 20130509 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Fresenius Kabi USA, LLC CUPRIC CHLORIDE; MANGANESE CHLORIDE; POTASSIUM IODIDE; SODIUM FLUORIDE; SODIUM SELENITE; ZINC CHLORIDE 20; 1; 1; 57; 2; 250 ug/mL; ug/mL; ug/mL; ug/mL; ug/mL; ug/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] 63323-161_69e8e21e-ab9f-459d-ad68-1f5417c00255 63323-161 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR; INTRAVENOUS 20010905 ANDA ANDA075784 Fresenius Kabi USA, LLC KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63323-162_69e8e21e-ab9f-459d-ad68-1f5417c00255 63323-162 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 20001018 ANDA ANDA075784 Fresenius Kabi USA, LLC KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63323-165_faf97329-3b0f-438c-8fc0-af3e307d6f7a 63323-165 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000907 ANDA ANDA084916 Fresenius Kabi USA, LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63323-170_2cec99ab-8268-4142-b032-58d3baf2f48b 63323-170 HUMAN PRESCRIPTION DRUG Sodium Phosphates SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 20000906 UNAPPROVED DRUG OTHER Fresenius Kabi USA, LLC SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 142; 276 mg/mL; mg/mL 63323-172_d9188744-e7ac-444a-9c55-6b16e58056a3 63323-172 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION, SOLUTION INTRAVENOUS 20090915 ANDA ANDA077432 APP Pharmaceuticals, LLC CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 63323-173_3a8579af-e7a0-419b-a8bc-00e3d59ce5b1 63323-173 HUMAN PRESCRIPTION DRUG Gentamicin GENTAMICIN INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041129 ANDA ANDA062366 APP Pharmaceuticals, LLC GENTAMICIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 63323-173_4b24319c-1ec0-4dfa-a98c-757a3b856ea1 63323-173 HUMAN PRESCRIPTION DRUG Gentamicin GENTAMICIN INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041129 ANDA ANDA062366 Fresenius Kabi USA, LLC GENTAMICIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 63323-173_e42dfaed-20c4-4395-a086-346aace8e9d7 63323-173 HUMAN PRESCRIPTION DRUG Gentamicin GENTAMICIN INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041129 ANDA ANDA062366 Fresenius Kabi USA, LLC GENTAMICIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 63323-174_cb3778b6-f8a9-443d-8914-c5a25d22bd36 63323-174 HUMAN PRESCRIPTION DRUG Ifosfamide IFOSFAMIDE INJECTION, SOLUTION INTRAVENOUS 20090930 ANDA ANDA090181 APP Pharmaceuticals, LLC IFOSFAMIDE 50 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] 63323-180_ca892d90-8b34-4ca2-9fc2-26dae433142a 63323-180 HUMAN PRESCRIPTION DRUG Pyridoxine Hydrochloride PYRIDOXINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19720814 ANDA ANDA080618 APP Pharmaceuticals, LLC PYRIDOXINE HYDROCHLORIDE 100 mg/mL 63323-184_fc0211a8-729b-42af-9fee-8e3f660e3a38 63323-184 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20000905 ANDA ANDA089202 APP Pharmaceuticals, LLC FOLIC ACID 5 mg/mL 63323-185_04adfa5a-4014-43e4-9be7-7e503ed9c0fd 63323-185 HUMAN PRESCRIPTION DRUG Sterile Water WATER INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20000905 ANDA ANDA088400 Fresenius Kabi USA, LLC 63323-185_0b7b12bc-129f-4569-ac63-cd7c90ba7e57 63323-185 HUMAN PRESCRIPTION DRUG Sterile Water WATER INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20000905 ANDA ANDA088400 Fresenius Kabi USA, LLC 63323-186_3144702a-2e6b-4126-9d63-2cae080777d4 63323-186 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION INTRAVENOUS 20000810 ANDA ANDA088912 APP Pharmaceuticals, LLC SODIUM CHLORIDE 9 mg/mL 63323-186_9d0f7f90-ef08-4929-bfb4-c7d1abe7aee1 63323-186 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20000810 UNAPPROVED DRUG OTHER APP Pharmaceuticals, LLC SODIUM CHLORIDE 9 mg/mL 63323-187_fb76dfe1-b526-41fe-99c3-cf8f10a1d41d 63323-187 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20000905 UNAPPROVED DRUG OTHER APP Pharmaceuticals, LLC SODIUM CHLORIDE 234 mg/mL 63323-192_d56d6b53-4f32-494b-ae56-6df241b645e8 63323-192 HUMAN PRESCRIPTION DRUG Fludarabine FLUDARABINE PHOSPHATE INJECTION, SOLUTION INTRAVENOUS 20071116 ANDA ANDA078393 APP Pharmaceuticals, LLC FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 63323-193_ec7062ad-7aa9-47ea-a20f-817aff3025ce 63323-193 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION INTRAVENOUS 20090401 ANDA ANDA078188 APP Pharmaceuticals, LLC IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 63323-194_44000fed-f3b5-408e-bfdb-8a51ad15b16f 63323-194 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20090811 ANDA ANDA065440 APP Pharmaceuticals, LLC IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 63323-196_f1ffd18c-9f6b-4479-94b9-6890bc730ecc 63323-196 HUMAN PRESCRIPTION DRUG Fludarabine FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091211 ANDA ANDA078544 APP Pharmaceuticals, LLC FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 63323-201_a40610ac-b8d6-4a75-aeb6-fbea90371b74 63323-201 HUMAN PRESCRIPTION DRUG Lidocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100527 ANDA ANDA080404 APP Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-201_cddb2b22-fce3-8967-6e54-dca3df5ac4b3 63323-201 HUMAN PRESCRIPTION DRUG Lidocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100527 ANDA ANDA088586 APP Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-202_a40610ac-b8d6-4a75-aeb6-fbea90371b74 63323-202 HUMAN PRESCRIPTION DRUG Lidocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100527 ANDA ANDA080404 APP Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-208_271fc9f2-eb00-49ec-b299-8dbef759344a 63323-208 HUMAN PRESCRIPTION DRUG Lidocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20000905 NDA NDA017584 APP Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-211_0fabb87d-72ff-4325-86dc-b53da680361e 63323-211 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140908 NDA NDA022160 APP Pharmaceuticals, LLC OXALIPLATIN 50 mg/10mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 63323-212_0fabb87d-72ff-4325-86dc-b53da680361e 63323-212 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140908 NDA NDA022160 APP Pharmaceuticals, LLC OXALIPLATIN 100 mg/20mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 63323-221_a1f3c0e3-d444-4aa8-be67-eee364a2781b 63323-221 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20000901 ANDA ANDA062663 APP Pharmaceuticals, LLC VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 63323-229_0a6b4c50-2f94-4191-bbfe-842aa458ab8f 63323-229 HUMAN PRESCRIPTION DRUG Protamine Sulfate PROTAMINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20001018 ANDA ANDA089454 Fresenius Kabi USA, LLC PROTAMINE SULFATE 10 mg/mL Heparin Binding Activity [MoA],Heparin Reversal Agent [EPC],Reversed Anticoagulation Activity [PE] 63323-229_75e45044-0fca-46c6-94d3-ca8907815ed1 63323-229 HUMAN PRESCRIPTION DRUG Protamine Sulfate PROTAMINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20001018 ANDA ANDA089454 Fresenius Kabi USA, LLC PROTAMINE SULFATE 10 mg/mL Heparin Binding Activity [MoA],Heparin Reversal Agent [EPC],Reversed Anticoagulation Activity [PE] 63323-229_f00537e9-533b-415e-bba7-cd8842a42e0d 63323-229 HUMAN PRESCRIPTION DRUG Protamine Sulfate PROTAMINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20001018 ANDA ANDA089454 Fresenius Kabi USA, LLC PROTAMINE SULFATE 10 mg/mL Heparin Binding Activity [MoA],Heparin Reversal Agent [EPC],Reversed Anticoagulation Activity [PE] 63323-236_7031149d-ae40-4d77-907f-ee461f36e98e 63323-236 HUMAN PRESCRIPTION DRUG CEFAZOLIN CEFAZOLIN SODIUM POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110715 ANDA ANDA065303 APP Pharmaceuticals, LLC CEFAZOLIN SODIUM 500 mg/2.2mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-237_7031149d-ae40-4d77-907f-ee461f36e98e 63323-237 HUMAN PRESCRIPTION DRUG CEFAZOLIN CEFAZOLIN SODIUM POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110715 ANDA ANDA065303 APP Pharmaceuticals, LLC CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-238_47a8928f-708d-418a-829b-36eded96bac0 63323-238 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin Sodium POWDER, FOR SOLUTION INTRAVENOUS 20110614 ANDA ANDA065306 APP Pharmaceuticals, LLC CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-241_0bc61980-d4a9-4b9a-864b-d4a25cbe49e0 63323-241 HUMAN PRESCRIPTION DRUG Glycophos SODIUM GLYCOLATE INJECTION, SOLUTION INTRAVENOUS; INTRAVENOUS 20130513 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Fresenius Kabi USA, LLC SODIUM GLYCEROPHOSPHATE ANHYDROUS 216 mg/mL 63323-249_04adfa5a-4014-43e4-9be7-7e503ed9c0fd 63323-249 HUMAN PRESCRIPTION DRUG Bacteriostatic Water WATER INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20001008 UNAPPROVED DRUG OTHER Fresenius Kabi USA, LLC WATER 1 mg/mL 63323-255_669c88ca-530b-469a-9356-807febe98682 63323-255 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041130 ANDA ANDA040583 Fresenius Kabi USA, LLC METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63323-258_669c88ca-530b-469a-9356-807febe98682 63323-258 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041130 ANDA ANDA040583 Fresenius Kabi USA, LLC METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63323-259_728b4d81-03a7-4e2c-809a-50c5bf5a29f2 63323-259 HUMAN PRESCRIPTION DRUG Bacteriostatic Sodium Chloride SODIUM CHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20000901 UNAPPROVED DRUG OTHER APP Pharmaceuticals, LLC SODIUM CHLORIDE 9 mg/mL 63323-260_b1469cc4-8c90-836b-a7cd-39f9cc1f63b6 63323-260 HUMAN PRESCRIPTION DRUG Polocaine-MPF MEPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20090720 ANDA ANDA089406 APP Pharmaceuticals, LLC MEPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-261_ec935d09-fb3f-45e4-8a56-4638a75f1618 63323-261 HUMAN PRESCRIPTION DRUG Progesterone PROGESTERONE INJECTION, SOLUTION INTRAMUSCULAR 20010719 ANDA ANDA075906 Fresenius Kabi USA, LLC PROGESTERONE 50 mg/mL Progesterone [Chemical/Ingredient],Progesterone [EPC] 63323-262_3bbce5c9-3dd0-4675-9a87-a2d786b435e6 63323-262 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63323-262_694bf8e2-ad7d-409e-8a23-d63a3e84f9e7 63323-262 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20090812 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63323-265_669c88ca-530b-469a-9356-807febe98682 63323-265 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041130 ANDA ANDA040612 Fresenius Kabi USA, LLC METHYLPREDNISOLONE SODIUM SUCCINATE 1 g/16mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63323-268_55057dd7-f616-4919-afab-21a0a5eef69e 63323-268 HUMAN PRESCRIPTION DRUG Scopolamine Hydrobromide SCOPOLAMINE HYDROBROMIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20001018 UNAPPROVED DRUG OTHER APP Pharmaceuticals, LLC SCOPOLAMINE HYDROBROMIDE .4 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 63323-269_01c16360-6310-4741-bd9f-c626588c858a 63323-269 HUMAN PRESCRIPTION DRUG Diprivan PROPOFOL INJECTION, EMULSION INTRAVENOUS 20091117 NDA NDA019627 Fresenius Kabi USA, LLC PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 63323-269_7ce5c2eb-c26d-4131-a558-4d892b9e8158 63323-269 HUMAN PRESCRIPTION DRUG Diprivan PROPOFOL INJECTION, EMULSION INTRAVENOUS 20091113 NDA NDA019627 Fresenius Kabi USA, LLC PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 63323-269_c48c7061-9258-412a-8361-32a2a6fcf4e5 63323-269 HUMAN PRESCRIPTION DRUG Diprivan PROPOFOL INJECTION, EMULSION INTRAVENOUS 20091113 NDA NDA019627 Fresenius Kabi USA, LLC PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 63323-269_c8a4e5e0-64ff-49e1-af1f-8ba61cec0c71 63323-269 HUMAN PRESCRIPTION DRUG Diprivan PROPOFOL INJECTION, EMULSION INTRAVENOUS 20091113 NDA NDA019627 Fresenius Kabi USA, LLC PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 63323-270_454ceeef-5f00-4da6-9236-b17c7bbf656c 63323-270 HUMAN PRESCRIPTION DRUG Propofol PROPOFOL INJECTION, EMULSION INTRAVENOUS 20091023 NDA NDA019627 APP Pharmaceuticals, LLC PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 63323-270_69c35f8e-20ea-4824-8982-82d584f95d5b 63323-270 HUMAN PRESCRIPTION DRUG Propofol PROPOFOL INJECTION, EMULSION INTRAVENOUS 20091007 NDA NDA019627 Fresenius Kabi USA, LLC PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 63323-270_702f57e2-fae5-44bf-91e8-e54217c08b41 63323-270 HUMAN PRESCRIPTION DRUG Propofol PROPOFOL INJECTION, EMULSION INTRAVENOUS 20091023 NDA NDA019627 APP Pharmaceuticals, LLC PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 63323-270_ea7567c4-4bf9-58f1-1ccb-65d1a1a8c620 63323-270 HUMAN PRESCRIPTION DRUG Propofol PROPOFOL INJECTION, EMULSION INTRAVENOUS 20091023 NDA NDA019627 APP Pharmaceuticals, LLC PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 63323-272_f8ba014e-aea0-49bc-8345-4e0a384b484e 63323-272 HUMAN PRESCRIPTION DRUG Fluphenazine Decanoate FLUPHENAZINE DECANOATE INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20101215 ANDA ANDA071413 APP Pharmaceuticals, LLC FLUPHENAZINE DECANOATE 25 mg/mL 63323-273_b8767d1e-0266-4192-8973-b1eabd0b00bb 63323-273 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate SUMATRIPTAN INJECTION SUBCUTANEOUS 20110412 ANDA ANDA079242 APP Pharmaceuticals, LLC SUMATRIPTAN 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 63323-276_3bbce5c9-3dd0-4675-9a87-a2d786b435e6 63323-276 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63323-278_15f6dd30-bd5d-41ad-951e-fa481ed97739 63323-278 HUMAN PRESCRIPTION DRUG Vinblastine Sulfate VINBLASTINE SULFATE INJECTION INTRAVENOUS 20000712 ANDA ANDA089515 APP Pharmaceuticals, LLC VINBLASTINE SULFATE 1 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 63323-280_060f0f4b-a617-44ab-b38c-9799817ab925 63323-280 HUMAN PRESCRIPTION DRUG Furosemide FUROSEMIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000712 NDA NDA018902 APP Pharmaceuticals, LLC FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63323-281_d571f04f-6190-42f2-932c-5a075fd978b9 63323-281 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR 20101228 ANDA ANDA089556 APP Pharmaceuticals, LLC FLUPHENAZINE HYDROCHLORIDE 2.5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 63323-282_b8133f76-8880-4b91-a451-b3f831ad6853 63323-282 HUMAN PRESCRIPTION DRUG Clindamycin CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091122 ANDA ANDA065347 APP Pharmaceuticals, LLC CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 63323-282_bd1c1648-4733-4233-8337-469fe11bd0cb 63323-282 HUMAN PRESCRIPTION DRUG Clindamycin CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION INTRAVENOUS 20091122 ANDA ANDA065346 APP Pharmaceuticals, LLC CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 63323-283_b1469cc4-8c90-836b-a7cd-39f9cc1f63b6 63323-283 HUMAN PRESCRIPTION DRUG Polocaine MEPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 20090720 ANDA ANDA089407 APP Pharmaceuticals, LLC MEPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-284_a1f3c0e3-d444-4aa8-be67-eee364a2781b 63323-284 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20000920 ANDA ANDA062663 APP Pharmaceuticals, LLC VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 63323-285_08193fc8-8d47-49ad-a1e6-62dbd4c63e45 63323-285 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20110531 NDA NDA020533 Fresenius Kabi USA, LLC ROPIVACAINE HYDROCHLORIDE 2 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-285_bc60f654-8f07-46fb-a542-92d4f54bc143 63323-285 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20090804 NDA NDA020533 Fresenius Kabi USA, LLC ROPIVACAINE HYDROCHLORIDE 2 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-285_bdd0d918-4af8-4ac1-9927-06b0d308ce40 63323-285 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20090804 NDA NDA020533 Fresenius Kabi USA, LLC ROPIVACAINE HYDROCHLORIDE 2 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-286_08193fc8-8d47-49ad-a1e6-62dbd4c63e45 63323-286 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20110531 NDA NDA020533 Fresenius Kabi USA, LLC ROPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-286_bc60f654-8f07-46fb-a542-92d4f54bc143 63323-286 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20090804 NDA NDA020533 Fresenius Kabi USA, LLC ROPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-286_bdd0d918-4af8-4ac1-9927-06b0d308ce40 63323-286 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20090804 NDA NDA020533 Fresenius Kabi USA, LLC ROPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-286_cb8b926d-cf66-bc7e-c940-e820fd4e877c 63323-286 HUMAN PRESCRIPTION DRUG NAROPIN ROPIVACAINE HYDROCHLORIDE MONOHYDRATE INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20090804 NDA NDA020533 APP Pharmaceuticals, LLC ROPIVACAINE HYDROCHLORIDE MONOHYDRATE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-287_08193fc8-8d47-49ad-a1e6-62dbd4c63e45 63323-287 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; PERINEURAL 20110531 NDA NDA020533 Fresenius Kabi USA, LLC ROPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-288_08193fc8-8d47-49ad-a1e6-62dbd4c63e45 63323-288 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL 20110531 NDA NDA020533 Fresenius Kabi USA, LLC ROPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-288_bdd0d918-4af8-4ac1-9927-06b0d308ce40 63323-288 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL 20090804 NDA NDA020533 Fresenius Kabi USA, LLC ROPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-288_fa18a249-fd92-4bf9-82b3-df7c0d2bdf62 63323-288 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION EPIDURAL 20090804 NDA NDA020533 Fresenius Kabi USA, LLC ROPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-289_d0a64e03-fd5e-6a5e-00c4-de687bbf08b3 63323-289 HUMAN PRESCRIPTION DRUG EMLA LIDOCAINE CREAM TOPICAL 20090929 NDA NDA019941 APP Pharmaceuticals, LLC LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-290_d0a64e03-fd5e-6a5e-00c4-de687bbf08b3 63323-290 HUMAN PRESCRIPTION DRUG EMLA LIDOCAINE CREAM TOPICAL 20090929 NDA NDA019941 APP Pharmaceuticals, LLC LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-293_b1469cc4-8c90-836b-a7cd-39f9cc1f63b6 63323-293 HUMAN PRESCRIPTION DRUG Polocaine-MPF MEPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20090721 ANDA ANDA089408 APP Pharmaceuticals, LLC MEPIVACAINE HYDROCHLORIDE 15 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-294_b1469cc4-8c90-836b-a7cd-39f9cc1f63b6 63323-294 HUMAN PRESCRIPTION DRUG Polocaine-MPF MEPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20090721 ANDA ANDA089409 APP Pharmaceuticals, LLC MEPIVACAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-295_2b1d6752-c21b-41b9-af18-8e94f809f470 63323-295 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010717 ANDA ANDA062663 APP Pharmaceuticals, LLC VANCOMYCIN HYDROCHLORIDE 5 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 63323-296_b1469cc4-8c90-836b-a7cd-39f9cc1f63b6 63323-296 HUMAN PRESCRIPTION DRUG Polocaine MEPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 20090720 ANDA ANDA089410 APP Pharmaceuticals, LLC MEPIVACAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-297_ca4ad961-d984-41bc-bb92-569996f1a17c 63323-297 HUMAN PRESCRIPTION DRUG Propoven PROPOFOL INJECTION INTRAVENOUS 20120701 20150630 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE APP Pharmaceuticals, LLC PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 63323-300_ba5c4972-44c8-45d1-8f12-48c0a288af4e 63323-300 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN SODIUM,TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091013 ANDA ANDA065523 APP Pharmaceuticals, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 63323-302_b2ef839e-8e4a-482a-8998-b8ac75b138ef 63323-302 HUMAN PRESCRIPTION DRUG Vasopressin VASOPRESSIN INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20010717 UNAPPROVED DRUG OTHER Fresenius Kabi USA, LLC VASOPRESSIN 20 [USP'U]/mL 63323-302_e7874cf2-b5ca-46cc-bbb0-26ed60f85bcd 63323-302 HUMAN PRESCRIPTION DRUG Vasopressin VASOPRESSIN INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20010717 UNAPPROVED DRUG OTHER Fresenius Kabi USA, LLC VASOPRESSIN 20 [USP'U]/mL 63323-303_be4c8263-e865-44bf-9065-0c20dbaeadf8 63323-303 HUMAN PRESCRIPTION DRUG Tobramycin TOBRAMYCIN SULFATE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20051123 NDA NDA050789 APP Pharmaceuticals, LLC TOBRAMYCIN SULFATE 1200 mg/30mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 63323-304_44473c11-c305-4094-90cb-11e2526592e5 63323-304 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN SODIUM,TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110531 ANDA ANDA090498 APP Pharmaceuticals, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 36; 4.5 g/1; g/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 63323-305_99f41942-a3b1-4911-a1bf-43be3f247e0c 63323-305 HUMAN PRESCRIPTION DRUG Tobramycin TOBRAMYCIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041130 ANDA ANDA065122 Fresenius Kabi USA, LLC TOBRAMYCIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 63323-306_99f41942-a3b1-4911-a1bf-43be3f247e0c 63323-306 HUMAN PRESCRIPTION DRUG Tobramycin TOBRAMYCIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051123 ANDA ANDA065122 Fresenius Kabi USA, LLC TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 63323-306_d2ed3897-b51e-4451-96ac-4cf65dbc5780 63323-306 HUMAN PRESCRIPTION DRUG Tobramycin TOBRAMYCIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051123 ANDA ANDA065122 Fresenius Kabi USA, LLC TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 63323-307_bde552aa-dba4-4616-9fc9-81e0281e87e6 63323-307 HUMAN PRESCRIPTION DRUG Tobramycin TOBRAMYCIN SULFATE INJECTION, SOLUTION INTRAVENOUS 20041130 ANDA ANDA065120 Fresenius Kabi USA, LLC TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 63323-309_ba5c4972-44c8-45d1-8f12-48c0a288af4e 63323-309 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN SODIUM,TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091013 ANDA ANDA065523 APP Pharmaceuticals, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 63323-311_9bd6cde8-0aa2-4e7f-90fb-3118677432ee 63323-311 HUMAN PRESCRIPTION DRUG Calcium Gluconate CALCIUM GLUCONATE INJECTION, SOLUTION INTRAVENOUS 20000712 UNAPPROVED DRUG OTHER APP Pharmaceuticals, LLC CALCIUM GLUCONATE 94 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 63323-311_d166384d-8b2d-4d12-9488-3690273de0d4 63323-311 HUMAN PRESCRIPTION DRUG Calcium Gluconate CALCIUM GLUCONATE INJECTION, SOLUTION INTRAVENOUS 20000809 UNAPPROVED DRUG OTHER APP Pharmaceuticals, LLC CALCIUM GLUCONATE 94 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 63323-314_2b1d6752-c21b-41b9-af18-8e94f809f470 63323-314 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20041130 ANDA ANDA062663 APP Pharmaceuticals, LLC VANCOMYCIN HYDROCHLORIDE 10 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 63323-315_8d777a28-add1-412d-87c8-97f79c876f65 63323-315 HUMAN PRESCRIPTION DRUG Ganciclovir GANCICLOVIR SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100628 ANDA ANDA090658 Fresenius Kabi USA, LLC GANCICLOVIR SODIUM 500 mg/10mL Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 63323-315_dafaddc1-cf82-4ef8-922b-981380413d44 63323-315 HUMAN PRESCRIPTION DRUG Ganciclovir GANCICLOVIR SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100628 ANDA ANDA090658 APP Pharmaceuticals, LLC GANCICLOVIR SODIUM 500 mg/10mL Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 63323-317_5e7feed8-d321-43db-ba48-7e0e1306f972 63323-317 HUMAN PRESCRIPTION DRUG Granisetron GRANISETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20091120 ANDA ANDA078522 Fresenius Kabi USA, LLC GRANISETRON HYDROCHLORIDE .1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63323-318_5e7feed8-d321-43db-ba48-7e0e1306f972 63323-318 HUMAN PRESCRIPTION DRUG Granisetron GRANISETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20091120 ANDA ANDA078096 Fresenius Kabi USA, LLC GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63323-319_5e7feed8-d321-43db-ba48-7e0e1306f972 63323-319 HUMAN PRESCRIPTION DRUG Granisetron GRANISETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20091120 ANDA ANDA078090 Fresenius Kabi USA, LLC GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63323-320_ba5c4972-44c8-45d1-8f12-48c0a288af4e 63323-320 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN SODIUM,TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091013 ANDA ANDA065523 APP Pharmaceuticals, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 63323-321_fbc12c18-567b-41bc-89d0-efd29616615c 63323-321 HUMAN PRESCRIPTION DRUG Polymyxin B POLYMYXIN B SULFATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 20091117 ANDA ANDA065372 APP Pharmaceuticals, LLC POLYMYXIN B SULFATE 500000 [iU]/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 63323-322_0a1dd9b9-ada1-4bff-9dcb-18961254e9e8 63323-322 HUMAN PRESCRIPTION DRUG Imipenem and Cilastatin Imipenem and Cilastatin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120103 ANDA ANDA090577 Fresenius Kabi USA, LLC CILASTATIN SODIUM; IMIPENEM 500; 500 mg/20mL; mg/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 63323-322_2bb3a14d-313d-4d17-a148-921e33878c1d 63323-322 HUMAN PRESCRIPTION DRUG Imipenem and Cilastatin Imipenem and Cilastatin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120103 ANDA ANDA090577 APP Pharmaceuticals, LLC CILASTATIN SODIUM; IMIPENEM 500; 500 mg/1; mg/1 Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 63323-323_eddf85dc-0839-4d66-a454-dd4990c3c3bd 63323-323 HUMAN PRESCRIPTION DRUG Penicillin G Potassium PENICILLIN G POTASSIUM POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRATHECAL; INTRAVENOUS 20090901 ANDA ANDA065448 APP Pharmaceuticals, LLC PENICILLIN G POTASSIUM 5000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63323-324_eddf85dc-0839-4d66-a454-dd4990c3c3bd 63323-324 HUMAN PRESCRIPTION DRUG Penicillin G Potassium PENICILLIN G POTASSIUM POWDER, FOR SOLUTION INTRAVENOUS 20090901 ANDA ANDA065448 APP Pharmaceuticals, LLC PENICILLIN G POTASSIUM 20000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63323-325_a4f57fc5-4f33-43c3-8468-17de38803d06 63323-325 HUMAN PRESCRIPTION DRUG Acyclovir ACYCLOVIR SODIUM INJECTION, SOLUTION INTRAVENOUS 20001017 ANDA ANDA074930 Fresenius Kabi USA, LLC ACYCLOVIR SODIUM 50 mg/mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63323-325_d0f0fc50-cf59-4963-af54-a1fdc26aaa92 63323-325 HUMAN PRESCRIPTION DRUG Acyclovir ACYCLOVIR SODIUM INJECTION, SOLUTION INTRAVENOUS 20001017 ANDA ANDA074930 Fresenius Kabi USA, LLC ACYCLOVIR SODIUM 50 mg/mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63323-326_6c764eed-23c7-4eb0-a2f6-0d976dca5371 63323-326 HUMAN PRESCRIPTION DRUG Cefepime Cefepime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100830 ANDA ANDA065441 Fresenius Kabi USA, LLC CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-327_ccbd5e0c-26b8-4b5e-8fa9-d104de528775 63323-327 HUMAN PRESCRIPTION DRUG Nafcillin NAFCILLIN SODIUM POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110630 ANDA ANDA090002 APP Pharmaceuticals, LLC NAFCILLIN SODIUM 1 g/4mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63323-328_ccbd5e0c-26b8-4b5e-8fa9-d104de528775 63323-328 HUMAN PRESCRIPTION DRUG Nafcillin NAFCILLIN SODIUM POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110630 ANDA ANDA090002 APP Pharmaceuticals, LLC NAFCILLIN SODIUM 2 g/8mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63323-329_843ce59c-4259-40df-9f9e-ee24b7aa811d 63323-329 HUMAN PRESCRIPTION DRUG Bacitracin BACITRACIN INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20030128 ANDA ANDA065116 APP Pharmaceuticals, LLC BACITRACIN 50000 [iU]/1 Decreased Cell Wall Synthesis & Repair [PE] 63323-330_55cf0341-8568-42b1-9683-2f0b1615a7ae 63323-330 HUMAN PRESCRIPTION DRUG Nafcillin NAFCILLIN INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110427 ANDA ANDA090005 APP Pharmaceuticals, LLC NAFCILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63323-338_932d2e24-61a6-4b87-b3cf-d3bf6a53e2db 63323-338 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE CAPSULE ORAL 20120618 ANDA ANDA065453 APP Pharmaceuticals, LLC VANCOMYCIN HYDROCHLORIDE 125 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 63323-339_932d2e24-61a6-4b87-b3cf-d3bf6a53e2db 63323-339 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE CAPSULE ORAL 20120618 ANDA ANDA065453 APP Pharmaceuticals, LLC VANCOMYCIN HYDROCHLORIDE 250 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 63323-340_6c764eed-23c7-4eb0-a2f6-0d976dca5371 63323-340 HUMAN PRESCRIPTION DRUG Cefepime Cefepime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100830 ANDA ANDA065441 Fresenius Kabi USA, LLC CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-341_d02170ff-65aa-48b8-a922-94271c46ffa7 63323-341 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin Sodium POWDER, FOR SOLUTION INTRAVENOUS 20110706 ANDA ANDA065414 APP Pharmaceuticals, LLC CEFOXITIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-342_d02170ff-65aa-48b8-a922-94271c46ffa7 63323-342 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin Sodium POWDER, FOR SOLUTION INTRAVENOUS 20110706 ANDA ANDA065414 APP Pharmaceuticals, LLC CEFOXITIN SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-343_9f84f170-7202-49a6-b54b-817996de4f8b 63323-343 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120221 ANDA ANDA065415 APP Pharmaceuticals, LLC CEFOXITIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-344_2d85abba-95dc-4d26-bc67-9c45bf4781cb 63323-344 HUMAN PRESCRIPTION DRUG Ceftriaxone CEFTRIAXONE SODIUM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060308 ANDA ANDA065245 APP Pharmaceuticals, LLC CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-345_7ea1db43-40fa-417b-8911-ae98092070a0 63323-345 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110620 ANDA ANDA065329 APP Pharmaceuticals , LLC CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-346_7ea1db43-40fa-417b-8911-ae98092070a0 63323-346 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110620 ANDA ANDA065329 APP Pharmaceuticals , LLC CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-347_7ea1db43-40fa-417b-8911-ae98092070a0 63323-347 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110620 ANDA ANDA065329 APP Pharmaceuticals , LLC CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-348_8828d4c9-6e71-4d0a-9ca1-bd0d231184ab 63323-348 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110620 ANDA ANDA065328 APP Pharmaceuticals , LLC CEFTRIAXONE SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-349_0a1dd9b9-ada1-4bff-9dcb-18961254e9e8 63323-349 HUMAN PRESCRIPTION DRUG Imipenem and Cilastatin Imipenem and Cilastatin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120103 ANDA ANDA090577 Fresenius Kabi USA, LLC CILASTATIN SODIUM; IMIPENEM 250; 250 mg/20mL; mg/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 63323-349_2bb3a14d-313d-4d17-a148-921e33878c1d 63323-349 HUMAN PRESCRIPTION DRUG Imipenem and Cilastatin Imipenem and Cilastatin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120103 ANDA ANDA090577 APP Pharmaceuticals, LLC CILASTATIN SODIUM; IMIPENEM 250; 250 mg/1; mg/1 Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] 63323-351_1dbfe850-fb8f-402b-a3ed-50b82d57f3c0 63323-351 HUMAN PRESCRIPTION DRUG Rifampin RIFAMPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140821 ANDA ANDA091181 Fresenius Kabi USA, LLC RIFAMPIN 600 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 63323-352_c0ae7bae-5a98-4bb5-8f29-153aacacc74f 63323-352 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110524 ANDA ANDA064125 APP Pharmaceuticals, LLC CEFUROXIME 750 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-353_c0ae7bae-5a98-4bb5-8f29-153aacacc74f 63323-353 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110524 ANDA ANDA064125 APP Pharmaceuticals, LLC CEFUROXIME 1.5 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-354_48d601be-4a99-4808-841e-fe48d04f5d9b 63323-354 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100730 ANDA ANDA064124 APP Pharmaceuticals, LLC CEFUROXIME 7.5 g/80mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-355_1bc8c364-a085-420d-9cb0-cc54a98a14e3 63323-355 HUMAN PRESCRIPTION DRUG Levofloxacin LEVOFLOXACIN INJECTION INTRAVENOUS 20130620 ANDA ANDA200674 Fresenius Kabi USA, LLC LEVOFLOXACIN 5 mg/mL 63323-359_33ec208a-0659-415a-9924-3ab35e10fb80 63323-359 HUMAN PRESCRIPTION DRUG Kanamycin KANAMYCIN A SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20030128 ANDA ANDA065111 APP Pharmaceuticals, LLC KANAMYCIN A SULFATE 333 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 63323-365_69f2e51d-126a-474c-ad51-771d7c58f8e7 63323-365 HUMAN PRESCRIPTION DRUG Octreotide OCTREOTIDE ACETATE INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060314 ANDA ANDA077457 Fresenius Kabi USA, LLC OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 63323-365_c36b167e-77c9-492f-8ccb-d47a30360a54 63323-365 HUMAN PRESCRIPTION DRUG Octreotide OCTREOTIDE ACETATE INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060314 ANDA ANDA077457 Fresenius Kabi USA, LLC OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 63323-366_9de9d0c5-be81-4bc3-b1db-77b248d3ec7c 63323-366 HUMAN PRESCRIPTION DRUG Dimenhydrinate Dimenhydrinate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041129 ANDA ANDA040519 APP Pharmaceuticals, LLC DIMENHYDRINATE 50 mg/mL 63323-368_c68d2338-c43e-4a64-8da4-c93873c5a3c8 63323-368 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051129 ANDA ANDA065222 APP Pharmaceuticals, LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 63323-369_c68d2338-c43e-4a64-8da4-c93873c5a3c8 63323-369 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051129 ANDA ANDA065222 APP Pharmaceuticals, LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 63323-370_7a7a6041-f76c-4507-bf58-99e119328991 63323-370 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20061127 ANDA ANDA065314 APP Pharmaceuticals, LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 10; 5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 63323-373_e338df86-2858-4b13-ab02-d3541fa12d0e 63323-373 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20091118 ANDA ANDA076972 Fresenius Kabi USA, LLC ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63323-374_e338df86-2858-4b13-ab02-d3541fa12d0e 63323-374 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20091118 ANDA ANDA076974 Fresenius Kabi USA, LLC ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63323-376_69f2e51d-126a-474c-ad51-771d7c58f8e7 63323-376 HUMAN PRESCRIPTION DRUG Octreotide OCTREOTIDE ACETATE INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060314 ANDA ANDA077457 Fresenius Kabi USA, LLC OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 63323-376_c36b167e-77c9-492f-8ccb-d47a30360a54 63323-376 HUMAN PRESCRIPTION DRUG Octreotide OCTREOTIDE ACETATE INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060314 ANDA ANDA077457 Fresenius Kabi USA, LLC OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 63323-377_69f2e51d-126a-474c-ad51-771d7c58f8e7 63323-377 HUMAN PRESCRIPTION DRUG Octreotide OCTREOTIDE ACETATE INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060314 ANDA ANDA077457 Fresenius Kabi USA, LLC OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 63323-377_c36b167e-77c9-492f-8ccb-d47a30360a54 63323-377 HUMAN PRESCRIPTION DRUG Octreotide OCTREOTIDE ACETATE INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060314 ANDA ANDA077457 Fresenius Kabi USA, LLC OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 63323-378_69f2e51d-126a-474c-ad51-771d7c58f8e7 63323-378 HUMAN PRESCRIPTION DRUG Octreotide OCTREOTIDE ACETATE INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060314 ANDA ANDA077450 Fresenius Kabi USA, LLC OCTREOTIDE ACETATE 200 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 63323-379_69f2e51d-126a-474c-ad51-771d7c58f8e7 63323-379 HUMAN PRESCRIPTION DRUG Octreotide OCTREOTIDE ACETATE INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060314 ANDA ANDA077450 Fresenius Kabi USA, LLC OCTREOTIDE ACETATE 1000 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 63323-382_441accd6-92e0-4912-8a17-469be99d0242 63323-382 HUMAN PRESCRIPTION DRUG Neostigmine Methylsulfate NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20001018 UNAPPROVED DRUG OTHER Fresenius Kabi USA, LLC NEOSTIGMINE METHYLSULFATE 5 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 63323-383_441accd6-92e0-4912-8a17-469be99d0242 63323-383 HUMAN PRESCRIPTION DRUG Neostigmine Methylsulfate NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20000901 UNAPPROVED DRUG OTHER Fresenius Kabi USA, LLC NEOSTIGMINE METHYLSULFATE 1 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 63323-385_908f2524-d886-484c-9746-8682878de44e 63323-385 HUMAN PRESCRIPTION DRUG Cefotetan CEFOTETAN DISODIUM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091118 ANDA ANDA065374 APP Pharmaceuticals, LLC CEFOTETAN DISODIUM 1 g/10mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-386_908f2524-d886-484c-9746-8682878de44e 63323-386 HUMAN PRESCRIPTION DRUG Cefotetan CEFOTETAN DISODIUM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091118 ANDA ANDA065374 APP Pharmaceuticals, LLC CEFOTETAN DISODIUM 2 g/20mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-387_0642ef5e-7eff-4117-a0df-4bd15d7b7d63 63323-387 HUMAN PRESCRIPTION DRUG Ampicillin ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19870512 ANDA ANDA062719 APP Pharmaceuticals, Inc. AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63323-388_0642ef5e-7eff-4117-a0df-4bd15d7b7d63 63323-388 HUMAN PRESCRIPTION DRUG Ampicillin ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19870512 ANDA ANDA062719 APP Pharmaceuticals, Inc. AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63323-389_0642ef5e-7eff-4117-a0df-4bd15d7b7d63 63323-389 HUMAN PRESCRIPTION DRUG Ampicillin ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19870512 ANDA ANDA062719 APP Pharmaceuticals, Inc. AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63323-393_4c964093-4cd2-417f-9674-e47bf1a542fc 63323-393 HUMAN PRESCRIPTION DRUG Colistimethate COLISTIMETHATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091204 ANDA ANDA065364 Fresenius Kabi USA, LLC COLISTIMETHATE SODIUM 150 mg/2mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 63323-396_86bb9239-35be-466d-bbc4-bed63507ea58 63323-396 HUMAN PRESCRIPTION DRUG Cefotetan CEFOTETAN DISODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091203 ANDA ANDA065375 APP Pharmaceuticals, LLC CEFOTETAN DISODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-398_6d3d703f-c416-4211-8108-eae80859978f 63323-398 HUMAN PRESCRIPTION DRUG Azithromycin AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20060320 ANDA ANDA065179 Fresenius Kabi USA, LLC AZITHROMYCIN MONOHYDRATE 500 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 63323-398_795234cb-84ca-47e1-8703-e520914dbce4 63323-398 HUMAN PRESCRIPTION DRUG Azithromycin AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20060320 ANDA ANDA065179 Fresenius Kabi USA, LLC AZITHROMYCIN MONOHYDRATE 500 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 63323-398_9d42fd01-a01b-40a2-a6a6-733269d00a9a 63323-398 HUMAN PRESCRIPTION DRUG Azithromycin AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20060320 ANDA ANDA065179 Fresenius Kabi USA, LLC AZITHROMYCIN MONOHYDRATE 500 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 63323-399_0642ef5e-7eff-4117-a0df-4bd15d7b7d63 63323-399 HUMAN PRESCRIPTION DRUG Ampicillin ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19930712 ANDA ANDA062797 APP Pharmaceuticals, Inc. AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63323-400_0a25086e-2538-490d-abcc-53475a6834ae 63323-400 HUMAN PRESCRIPTION DRUG Levetiracetam LEVETIRACETAM INJECTION, SOLUTION INTRAVENOUS 20100603 ANDA ANDA090813 Fresenius Kabi USA, LLC LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63323-401_8b9fb753-74fe-4e7c-8532-ba985db52454 63323-401 HUMAN PRESCRIPTION DRUG Aztreonam AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091105 ANDA ANDA065439 Fresenius Kabi USA, LLC AZTREONAM 1 g/1 Monobactam Antibacterial [EPC],Monobactams [Chemical/Ingredient] 63323-401_d84afe3b-ca13-44cf-b0de-410165d07149 63323-401 HUMAN PRESCRIPTION DRUG Aztreonam AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091105 ANDA ANDA065439 Fresenius Kabi USA, LLC AZTREONAM 1 g/1 Monobactam Antibacterial [EPC],Monobactams [Chemical/Ingredient] 63323-402_8b9fb753-74fe-4e7c-8532-ba985db52454 63323-402 HUMAN PRESCRIPTION DRUG Aztreonam AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091105 ANDA ANDA065439 Fresenius Kabi USA, LLC AZTREONAM 2 g/1 Monobactam Antibacterial [EPC],Monobactams [Chemical/Ingredient] 63323-402_d84afe3b-ca13-44cf-b0de-410165d07149 63323-402 HUMAN PRESCRIPTION DRUG Aztreonam AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091105 ANDA ANDA065439 Fresenius Kabi USA, LLC AZTREONAM 2 g/1 Monobactam Antibacterial [EPC],Monobactams [Chemical/Ingredient] 63323-403_180e07cd-9489-4e87-b4c2-1cbdbaaf0c6d 63323-403 HUMAN PRESCRIPTION DRUG Fosphenytoin FOSPHENYTOIN SODIUM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091214 ANDA ANDA078052 Fresenius Kabi USA, LLC FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63323-403_353ff194-8853-4fc3-ae20-380a054e32ce 63323-403 HUMAN PRESCRIPTION DRUG Fosphenytoin FOSPHENYTOIN SODIUM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091214 ANDA ANDA078052 Fresenius Kabi USA, LLC FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63323-404_85bd67e5-386a-4ab8-af66-a2d2adefb54e 63323-404 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20131220 ANDA ANDA201404 APP Pharmaceuticals, LLC AMPICILLIN SODIUM 10 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 63323-405_a9313fb2-a25f-4b7e-aaad-b1a21fa58a71 63323-405 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL 20110708 ANDA ANDA200673 Fresenius Kabi USA, LLC CLONIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 63323-406_6dd6d2eb-1d77-4de6-9d26-9173b4790a41 63323-406 HUMAN PRESCRIPTION DRUG Caffeine Citrate CAFFEINE CITRATE SOLUTION ORAL 20091119 ANDA ANDA078002 APP Pharmaceuticals, LLC CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 63323-407_274ad4af-8cb8-400f-9467-a24e90e06fd7 63323-407 HUMAN PRESCRIPTION DRUG Caffeine Citrate CAFFEINE CITRATE INJECTION, SOLUTION INTRAVENOUS 20091119 ANDA ANDA077997 Fresenius Kabi USA, LLC CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 63323-407_bcdf81ce-a1e2-4e58-9d8e-de99aef821bb 63323-407 HUMAN PRESCRIPTION DRUG Caffeine Citrate CAFFEINE CITRATE INJECTION, SOLUTION INTRAVENOUS 20091119 ANDA ANDA077997 Fresenius Kabi USA, LLC CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 63323-411_6be45064-2059-4223-9382-832385548419 63323-411 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 APP Pharmaceuticals, LLC MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63323-412_6be45064-2059-4223-9382-832385548419 63323-412 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000710 ANDA ANDA075154 APP Pharmaceuticals, LLC MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63323-424_09e0dfb2-ed54-4800-9fde-a3b981863db7 63323-424 HUMAN PRESCRIPTION DRUG Flumazenil FLUMAZENIL INJECTION, SOLUTION INTRAVENOUS 20050405 ANDA ANDA076955 APP Pharmaceuticals, LLC FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 63323-426_7318a043-ab9a-447c-8a2d-5b6956b0a360 63323-426 HUMAN PRESCRIPTION DRUG Rocuronium ROCURONIUM BROMIDE INJECTION, SOLUTION INTRAVENOUS 20091213 ANDA ANDA078651 Fresenius Kabi USA, LLC ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 63323-427_a9313fb2-a25f-4b7e-aaad-b1a21fa58a71 63323-427 HUMAN PRESCRIPTION DRUG Clonidine CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL 20110708 ANDA ANDA200673 Fresenius Kabi USA, LLC CLONIDINE HYDROCHLORIDE 500 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 63323-446_65a0b0f7-f729-4e77-9ccd-6a526507b215 63323-446 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120713 ANDA ANDA063209 APP Pharmaceuticals, LLC CEFAZOLIN SODIUM 20 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63323-459_3bbce5c9-3dd0-4675-9a87-a2d786b435e6 63323-459 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20110425 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63323-460_81edac1d-538c-4472-9d35-ff1b9d0d7328 63323-460 HUMAN PRESCRIPTION DRUG SENSORCAINE MPF BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; RETROBULBAR 20101119 NDA NDA018304 Fresenius Kabi USA, LLC BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 7.5; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 63323-461_b4313b7a-a034-4599-ae88-11b93706b5f9 63323-461 HUMAN PRESCRIPTION DRUG SENSORCAINE BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20101119 ANDA ANDA070967 Fresenius Kabi USA, LLC BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 63323-462_81edac1d-538c-4472-9d35-ff1b9d0d7328 63323-462 HUMAN PRESCRIPTION DRUG SENSORCAINE MPF BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INTRACAUDAL; PERINEURAL 20101119 NDA NDA018304 Fresenius Kabi USA, LLC BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 5; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 63323-463_b4313b7a-a034-4599-ae88-11b93706b5f9 63323-463 HUMAN PRESCRIPTION DRUG SENSORCAINE BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE INJECTION, SOLUTION PERINEURAL 20101119 ANDA ANDA070968 Fresenius Kabi USA, LLC BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 5; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 63323-464_81edac1d-538c-4472-9d35-ff1b9d0d7328 63323-464 HUMAN PRESCRIPTION DRUG SENSORCAINE MPF BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20101119 NDA NDA018304 Fresenius Kabi USA, LLC BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-464_adecdf6d-ff96-4146-95c6-b4c431de804c 63323-464 HUMAN PRESCRIPTION DRUG Sensorcaine MPF BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20101119 ANDA ANDA070552 Fresenius Kabi USA, LLC BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-465_81edac1d-538c-4472-9d35-ff1b9d0d7328 63323-465 HUMAN PRESCRIPTION DRUG SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20101119 NDA NDA018304 Fresenius Kabi USA, LLC BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-466_81edac1d-538c-4472-9d35-ff1b9d0d7328 63323-466 HUMAN PRESCRIPTION DRUG SENSORCAINE MPF BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INTRACAUDAL; PERINEURAL 20101119 NDA NDA018304 Fresenius Kabi USA, LLC BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-466_adecdf6d-ff96-4146-95c6-b4c431de804c 63323-466 HUMAN PRESCRIPTION DRUG Sensorcaine MPF BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INTRACAUDAL; PERINEURAL 20101119 ANDA ANDA070553 Fresenius Kabi USA, LLC BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-467_81edac1d-538c-4472-9d35-ff1b9d0d7328 63323-467 HUMAN PRESCRIPTION DRUG SENSORCAINE BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION PERINEURAL 20101119 NDA NDA018304 Fresenius Kabi USA, LLC BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-468_b4313b7a-a034-4599-ae88-11b93706b5f9 63323-468 HUMAN PRESCRIPTION DRUG SENSORCAINE MPF BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20101119 ANDA ANDA070966 Fresenius Kabi USA, LLC BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 63323-469_023d99fb-ae30-4399-b9a3-b613e930cf6e 63323-469 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate HALOPERIDOL DECANOATE INJECTION INTRAMUSCULAR 20000216 ANDA ANDA074893 Fresenius Kabi USA, LLC HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] 63323-471_023d99fb-ae30-4399-b9a3-b613e930cf6e 63323-471 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate HALOPERIDOL DECANOATE INJECTION INTRAMUSCULAR 20000712 ANDA ANDA074893 Fresenius Kabi USA, LLC HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] 63323-472_b4313b7a-a034-4599-ae88-11b93706b5f9 63323-472 HUMAN PRESCRIPTION DRUG SENSORCAINE MPF BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; RETROBULBAR 20101119 ANDA ANDA070554 Fresenius Kabi USA, LLC BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-473_003494b8-9599-47be-b4b1-5fab2d4434fa 63323-473 HUMAN PRESCRIPTION DRUG Sensorcaine MPF BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION SUBARACHNOID 20100525 ANDA ANDA071202 Fresenius Kabi USA, LLC BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 63323-474_394acfe3-b2b3-4435-865b-d781b9df0c46 63323-474 HUMAN PRESCRIPTION DRUG Haloperidol HALOPERIDOL LACTATE INJECTION, SOLUTION INTRAMUSCULAR 20001020 ANDA ANDA075689 Fresenius Kabi USA, LLC HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] 63323-475_85b542c0-390d-4939-943a-e37496de7b08 63323-475 HUMAN PRESCRIPTION DRUG Nesacaine CHLOROPROCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20101014 NDA NDA009435 Fresenius Kabi USA, LLC CHLOROPROCAINE HYDROCHLORIDE 10 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 63323-476_85b542c0-390d-4939-943a-e37496de7b08 63323-476 HUMAN PRESCRIPTION DRUG Nesacaine CHLOROPROCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20101014 NDA NDA009435 Fresenius Kabi USA, LLC CHLOROPROCAINE HYDROCHLORIDE 20 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 63323-477_85b542c0-390d-4939-943a-e37496de7b08 63323-477 HUMAN PRESCRIPTION DRUG Nesacaine MPF CHLOROPROCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20101014 NDA NDA009435 Fresenius Kabi USA, LLC CHLOROPROCAINE HYDROCHLORIDE 20 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 63323-478_85b542c0-390d-4939-943a-e37496de7b08 63323-478 HUMAN PRESCRIPTION DRUG Nesacaine MPF CHLOROPROCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20101014 NDA NDA009435 Fresenius Kabi USA, LLC CHLOROPROCAINE HYDROCHLORIDE 30 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 63323-479_1d66308c-c24e-4016-b432-28da016a3385 63323-479 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE JELLY TOPICAL 20100927 NDA NDA008816 APP Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-481_903fd0f6-4815-4252-a420-2969aa7ff0b1 63323-481 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 APP Pharmaceuticals, LLC EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .005; 5 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 63323-482_903fd0f6-4815-4252-a420-2969aa7ff0b1 63323-482 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 APP Pharmaceuticals, LLC EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 10 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 63323-483_903fd0f6-4815-4252-a420-2969aa7ff0b1 63323-483 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 APP Pharmaceuticals, LLC EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 63323-484_903fd0f6-4815-4252-a420-2969aa7ff0b1 63323-484 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 APP Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-485_903fd0f6-4815-4252-a420-2969aa7ff0b1 63323-485 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 APP Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-486_903fd0f6-4815-4252-a420-2969aa7ff0b1 63323-486 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 APP Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-487_903fd0f6-4815-4252-a420-2969aa7ff0b1 63323-487 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812 NDA NDA006488 APP Pharmaceuticals, LLC EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .005; 10 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 63323-488_903fd0f6-4815-4252-a420-2969aa7ff0b1 63323-488 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812 NDA NDA006488 APP Pharmaceuticals, LLC EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .005; 15 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 63323-489_903fd0f6-4815-4252-a420-2969aa7ff0b1 63323-489 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812 NDA NDA006488 APP Pharmaceuticals, LLC EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .005; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 63323-490_8ec9161c-0ecc-4d29-b31c-fc5a64e6952e 63323-490 HUMAN PRESCRIPTION DRUG Xylocaine-MPF LIDOCAINE HYDROCHLORIDE SOLUTION RETROBULBAR; TOPICAL 20091111 NDA NDA010417 APP Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-491_903fd0f6-4815-4252-a420-2969aa7ff0b1 63323-491 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 20100812 NDA NDA006488 APP Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-492_855b81f2-465c-4682-989b-d019a3c0540b 63323-492 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20110718 NDA NDA006488 Fresenius Kabi USA, LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-492_903fd0f6-4815-4252-a420-2969aa7ff0b1 63323-492 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812 NDA NDA006488 APP Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-493_855b81f2-465c-4682-989b-d019a3c0540b 63323-493 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20110718 NDA NDA006488 Fresenius Kabi USA, LLC LIDOCAINE HYDROCHLORIDE 15 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-494_482c0b17-fb7b-44ee-a691-eae2a639dd3f 63323-494 HUMAN PRESCRIPTION DRUG Valproate Sodium VALPROATE SODIUM INJECTION, SOLUTION INTRAVENOUS 20030818 ANDA ANDA076539 Fresenius Kabi USA, LLC VALPROATE SODIUM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 63323-495_903fd0f6-4815-4252-a420-2969aa7ff0b1 63323-495 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812 NDA NDA006488 APP Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-496_855b81f2-465c-4682-989b-d019a3c0540b 63323-496 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20110718 NDA NDA006488 Fresenius Kabi USA, LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-496_903fd0f6-4815-4252-a420-2969aa7ff0b1 63323-496 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812 NDA NDA006488 APP Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-497_f917ee72-349e-40fa-a602-d7da17fd7ee7 63323-497 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE SOLUTION TOPICAL 20091111 NDA NDA010417 APP Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-498_efdd74b1-74b6-4630-a24a-373932e41c05 63323-498 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20091111 NDA NDA016801 APP Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63323-505_ccec1a48-d2f4-4130-93d9-d68502321b1d 63323-505 HUMAN PRESCRIPTION DRUG Sodium Citrate Blood-Pack Units, (PL 146 Plastic) Anticoagulant Sodium Citrate Solution SOLUTION INTRAVENOUS 20140929 NDA BN770923 Fresenius Kabi USA, LLC TRISODIUM CITRATE DIHYDRATE 4 g/100mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 63323-506_728c68a3-4ed0-4ae2-a451-ed6212bcc972 63323-506 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20030529 ANDA ANDA040491 Fresenius Kabi USA, LLC DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63323-507_3362a801-0654-42ee-bfe8-c2a3c6242552 63323-507 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20111014 ANDA ANDA091404 Fresenius Kabi USA, LLC MEROPENEM 500 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 63323-507_7a68d899-2678-43a9-a9c1-ef8f916b562f 63323-507 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20111014 ANDA ANDA091404 Fresenius Kabi USA, LLC MEROPENEM 500 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 63323-507_d4624cce-c1d7-47a0-9618-4fedbe0ce8b6 63323-507 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20111014 ANDA ANDA091404 Fresenius Kabi USA, LLC MEROPENEM 500 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 63323-508_3362a801-0654-42ee-bfe8-c2a3c6242552 63323-508 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20111026 ANDA ANDA091404 Fresenius Kabi USA, LLC MEROPENEM 1 g/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 63323-508_7a68d899-2678-43a9-a9c1-ef8f916b562f 63323-508 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20111026 ANDA ANDA091404 Fresenius Kabi USA, LLC MEROPENEM 1 g/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 63323-508_d4624cce-c1d7-47a0-9618-4fedbe0ce8b6 63323-508 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20111026 ANDA ANDA091404 Fresenius Kabi USA, LLC MEROPENEM 1 g/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] 63323-513_c25e8532-f15c-477f-9157-976b8d916a14 63323-513 HUMAN PRESCRIPTION DRUG Gentamicin GENTAMICIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19820304 ANDA ANDA062356 APP Pharmaceuticals, LLC GENTAMICIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 63323-516_728c68a3-4ed0-4ae2-a451-ed6212bcc972 63323-516 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050405 ANDA ANDA040572 Fresenius Kabi USA, LLC DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63323-540_3bbce5c9-3dd0-4675-9a87-a2d786b435e6 63323-540 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63323-540_694bf8e2-ad7d-409e-8a23-d63a3e84f9e7 63323-540 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20090812 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63323-542_3bbce5c9-3dd0-4675-9a87-a2d786b435e6 63323-542 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63323-543_3bbce5c9-3dd0-4675-9a87-a2d786b435e6 63323-543 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20101203 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 5000 [USP'U]/.5mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63323-549_6fee542c-cb91-42e6-94c4-2205b1f95601 63323-549 HUMAN PRESCRIPTION DRUG Heparin Lock Flush HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20090812 PREMARKET NOTIFICATION K092938 APP Pharmaceuticals, LLC HEPARIN SODIUM 100 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63323-557_6fee542c-cb91-42e6-94c4-2205b1f95601 63323-557 HUMAN PRESCRIPTION DRUG Heparin Lock Flush HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20090829 PREMARKET NOTIFICATION K092938 APP Pharmaceuticals, LLC HEPARIN SODIUM 10 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63323-563_282bd634-8020-4396-bfbd-936924ad5a94 63323-563 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20120524 ANDA ANDA091596 Fresenius Kabi USA, LLC TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 63323-563_c0ee4e7f-24b2-4b33-875f-3a5b02325162 63323-563 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20120420 ANDA ANDA202373 Fresenius Kabi USA, LLC TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 63323-597_85913c5c-c348-4347-bccf-1eb100944ace 63323-597 HUMAN PRESCRIPTION DRUG Deferoxamine DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20091215 ANDA ANDA078718 APP Pharmaceuticals, LLC DEFEROXAMINE MESYLATE 95 mg/mL Iron Chelating Activity [MoA],Iron Chelator [EPC] 63323-599_85913c5c-c348-4347-bccf-1eb100944ace 63323-599 HUMAN PRESCRIPTION DRUG Deferoxamine DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20091215 ANDA ANDA078718 APP Pharmaceuticals, LLC DEFEROXAMINE MESYLATE 95 mg/mL Iron Chelating Activity [MoA],Iron Chelator [EPC] 63323-604_d571e396-79ee-4c0b-b2d4-641856f006f9 63323-604 HUMAN PRESCRIPTION DRUG Propranolol PROPRANOLOL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20010907 ANDA ANDA075826 APP Pharmaceuticals, LLC PROPRANOLOL HYDROCHLORIDE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63323-614_73a3cb12-0ac4-4e79-9d5d-6697bfd71db3 63323-614 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride HYDRALAZINE HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20010905 ANDA ANDA040388 Fresenius Kabi USA, LLC HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 63323-614_d676ecfd-e615-4274-aa3c-e6505f9d56fa 63323-614 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride HYDRALAZINE HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20110131 ANDA ANDA040388 Fresenius Kabi USA, LLC HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 63323-616_34ce97f0-672a-4588-87a5-d399fb4ff1c4 63323-616 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20030128 ANDA ANDA075761 APP Pharmaceuticals, LLC AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 63323-617_7a801fcc-a46c-44b8-b40f-62a681feb80d 63323-617 HUMAN PRESCRIPTION DRUG Milrinone Lactate MILRINONE LACTATE INJECTION, SOLUTION INTRAVENOUS 20020801 ANDA ANDA075936 APP Pharmaceuticals, LLC MILRINONE LACTATE 1 mg/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 63323-623_5f0e3260-d0fa-452e-941d-2962379c3d91 63323-623 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20140218 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Fresenius Kabi USA, LLC SODIUM CHLORIDE 9 mg/mL 63323-647_1001cac8-bb9d-4abc-bc8f-c4c28dc3839e 63323-647 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium LEVOTHYROXINE SODIUM ANHYDROUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110624 NDA NDA202231 Fresenius Kabi USA, LLC LEVOTHYROXINE SODIUM ANHYDROUS 200 ug/5mL l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63323-647_8f45a93f-a6a5-4f34-a268-dce05e2af408 63323-647 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium LEVOTHYROXINE SODIUM ANHYDROUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110624 NDA NDA202231 Fresenius Kabi USA, LLC LEVOTHYROXINE SODIUM ANHYDROUS 200 ug/5mL l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63323-648_1001cac8-bb9d-4abc-bc8f-c4c28dc3839e 63323-648 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium LEVOTHYROXINE SODIUM ANHYDROUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110624 NDA NDA202231 Fresenius Kabi USA, LLC LEVOTHYROXINE SODIUM ANHYDROUS 500 ug/5mL l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63323-648_21817343-09df-40de-95c0-3bdd95f9d3b0 63323-648 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium LEVOTHYROXINE SODIUM ANHYDROUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110624 NDA NDA202231 Fresenius Kabi USA, LLC LEVOTHYROXINE SODIUM ANHYDROUS 500 ug/5mL l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63323-649_1001cac8-bb9d-4abc-bc8f-c4c28dc3839e 63323-649 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium LEVOTHYROXINE SODIUM ANHYDROUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110624 NDA NDA202231 Fresenius Kabi USA, LLC LEVOTHYROXINE SODIUM ANHYDROUS 100 ug/5mL l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63323-649_21817343-09df-40de-95c0-3bdd95f9d3b0 63323-649 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium LEVOTHYROXINE SODIUM ANHYDROUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110624 NDA NDA202231 Fresenius Kabi USA, LLC LEVOTHYROXINE SODIUM ANHYDROUS 100 ug/5mL l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63323-649_8f45a93f-a6a5-4f34-a268-dce05e2af408 63323-649 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium LEVOTHYROXINE SODIUM ANHYDROUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110624 NDA NDA202231 Fresenius Kabi USA, LLC LEVOTHYROXINE SODIUM ANHYDROUS 100 ug/5mL l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63323-650_b97beb41-3432-42ea-9caf-3a86468f2a04 63323-650 HUMAN PRESCRIPTION DRUG oxaliplatin oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100611 ANDA ANDA078811 APP Pharmaceuticals, LLC OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 63323-651_3448641f-36a1-41e0-88b9-e71dfc936bad 63323-651 HUMAN PRESCRIPTION DRUG Adenosine ADENOSINE INJECTION, SOLUTION INTRAVENOUS 20051123 ANDA ANDA077133 Fresenius Kabi USA, LLC ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 63323-652_0f72d1b6-81cf-48f4-bf10-42b001a516f2 63323-652 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20041130 ANDA ANDA076573 Fresenius Kabi USA, LLC ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63323-658_6cc4939b-716b-472b-abe7-a16e6aba949d 63323-658 HUMAN PRESCRIPTION DRUG Chlorothiazide CHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091021 ANDA ANDA090896 Fresenius Kabi USA, LLC CHLOROTHIAZIDE SODIUM 500 mg/18mL Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63323-658_de512e9b-444c-4ae4-8c6b-accd87a02021 63323-658 HUMAN PRESCRIPTION DRUG Chlorothiazide CHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091021 ANDA ANDA090896 APP Pharmaceuticals, LLC CHLOROTHIAZIDE SODIUM 500 mg/18mL Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63323-658_f5fe79d4-f571-4ede-9e73-d83a694b8b88 63323-658 HUMAN PRESCRIPTION DRUG Chlorothiazide CHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091021 ANDA ANDA090896 Fresenius Kabi USA, LLC CHLOROTHIAZIDE SODIUM 500 mg/18mL Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63323-659_34827ccd-d510-4d30-9f1d-ff6871dd7f33 63323-659 HUMAN PRESCRIPTION DRUG Indomethacin INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100319 NDA NDA022536 Fresenius Kabi USA, LLC INDOMETHACIN 1 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63323-659_49e66614-bc46-4573-b106-d3c3344b7d1c 63323-659 HUMAN PRESCRIPTION DRUG Indomethacin INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100319 NDA NDA022536 Fresenius Kabi USA, LLC INDOMETHACIN 1 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63323-659_89f255f1-77c9-4d47-b236-bb8df6c3ab96 63323-659 HUMAN PRESCRIPTION DRUG Indomethacin INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100319 NDA NDA022536 Fresenius Kabi USA, LLC INDOMETHACIN 1 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63323-660_0beadb2e-c866-4124-81ca-287533580137 63323-660 HUMAN PRESCRIPTION DRUG Metoprolol METOPROLOL TARTRATE INJECTION, SOLUTION INTRAVENOUS 20101028 ANDA ANDA091045 Fresenius Kabi USA, LLC METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63323-664_220d4a75-531f-499d-b5af-3aa846fd2c00 63323-664 HUMAN PRESCRIPTION DRUG Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020801 ANDA ANDA040466 APP Pharmaceuticals, LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 63323-665_be203fdb-578c-49a1-8a77-b15b80377d75 63323-665 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate TERBUTALINE SULFATE INJECTION, SOLUTION SUBCUTANEOUS 20110310 ANDA ANDA076887 APP Pharmaceuticals, LLC TERBUTALINE SULFATE 1 mg/mL 63323-690_2a60353b-9a4f-4bc8-8690-77ea688b7ea7 63323-690 HUMAN PRESCRIPTION DRUG Acetylcysteine ACETYLCYSTEINE SOLUTION ORAL; RESPIRATORY (INHALATION) 20120901 ANDA ANDA203853 Fresenius Kabi USA, LLC ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 63323-691_2a60353b-9a4f-4bc8-8690-77ea688b7ea7 63323-691 HUMAN PRESCRIPTION DRUG Acetylcysteine ACETYLCYSTEINE SOLUTION ORAL; RESPIRATORY (INHALATION) 20140331 ANDA ANDA204674 Fresenius Kabi USA, LLC ACETYLCYSTEINE 100 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 63323-692_2a60353b-9a4f-4bc8-8690-77ea688b7ea7 63323-692 HUMAN PRESCRIPTION DRUG Acetylcysteine ACETYLCYSTEINE SOLUTION ORAL; RESPIRATORY (INHALATION) 20120901 ANDA ANDA203853 Fresenius Kabi USA, LLC ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 63323-693_2a60353b-9a4f-4bc8-8690-77ea688b7ea7 63323-693 HUMAN PRESCRIPTION DRUG Acetylcysteine ACETYLCYSTEINE SOLUTION ORAL; RESPIRATORY (INHALATION) 20140331 ANDA ANDA204674 Fresenius Kabi USA, LLC ACETYLCYSTEINE 100 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 63323-694_2a60353b-9a4f-4bc8-8690-77ea688b7ea7 63323-694 HUMAN PRESCRIPTION DRUG Acetylcysteine ACETYLCYSTEINE SOLUTION ORAL; RESPIRATORY (INHALATION) 20120901 ANDA ANDA203853 Fresenius Kabi USA, LLC ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 63323-695_2a60353b-9a4f-4bc8-8690-77ea688b7ea7 63323-695 HUMAN PRESCRIPTION DRUG Acetylcysteine ACETYLCYSTEINE SOLUTION ORAL; RESPIRATORY (INHALATION) 20140331 ANDA ANDA204674 Fresenius Kabi USA, LLC ACETYLCYSTEINE 100 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 63323-710_524bf59a-3548-410f-8496-34946e037a9b 63323-710 HUMAN PRESCRIPTION DRUG Leucovorin Calcium LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100918 ANDA ANDA040258 Fresenius Kabi USA, LLC LEUCOVORIN CALCIUM 200 mg/20mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient] 63323-710_ec01dcf1-a37a-464d-b6de-a2404e479499 63323-710 HUMAN PRESCRIPTION DRUG Leucovorin Calcium LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100918 ANDA ANDA040258 APP Pharmaceuticals, LLC LEUCOVORIN CALCIUM 200 mg/20mL 63323-711_ec01dcf1-a37a-464d-b6de-a2404e479499 63323-711 HUMAN PRESCRIPTION DRUG Leucovorin Calcium LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100918 ANDA ANDA040286 APP Pharmaceuticals, LLC LEUCOVORIN CALCIUM 500 mg/50mL 63323-712_cd6fa98b-93ce-4e2d-b14a-83daff85fc61 63323-712 HUMAN PRESCRIPTION DRUG Kabiven DEXTROSE, SOYBEAN OIL, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine INJECTION, EMULSION INTRAVENOUS 20140825 NDA NDA200656 Fresenius Kabi USA, LLC ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; SOYBEAN OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 467; 330; 99; 29; 9.8; 164; 231; 199; 164; 231; 263; 96; 164; 231; 174; 199; 131; 239; 147; 3.9; 164; 55; 6.7; 213 mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 63323-714_d68723d6-f575-4628-9013-68dccff09fb9 63323-714 HUMAN PRESCRIPTION DRUG Perikabiven DEXTROSE, SOYBEAN OIL, SODIUM ACETATE, POTASSIUM CHLORIDE, SODIUM GLYCEROPHOSPHATE, MAGNESIUM SULFATE HEPTAHYDRATE, CALCIUM CHLORIDE, and LYSINE HYDROCHLORIDE INJECTION, EMULSION INTRAVENOUS 20140825 NDA NDA200656 Fresenius Kabi USA, LLC ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; SOYBEAN OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE 333; 235; 71; 20; 6.8; 116; 164; 141; 116; 164; 187; 68; 116; 164; 124; 141; 94; 170; 105; 3.5; 116; 40; 4.8; 152 mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Amino Acid [EPC],Amino Acids [Chemical/Ingredient] 63323-731_a21d9b87-293e-4662-b9a6-7015d3847331 63323-731 HUMAN PRESCRIPTION DRUG Calcitriol CALCITRIOL INJECTION, SOLUTION INTRAVENOUS 20030529 ANDA ANDA075836 Fresenius Kabi USA, LLC CALCITRIOL 1 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 63323-733_24e30ae5-dc3c-47c5-af22-8070744f4602 63323-733 HUMAN PRESCRIPTION DRUG Mesna MESNA INJECTION, SOLUTION INTRAVENOUS 20010905 ANDA ANDA075811 APP Pharmaceuticals, LLC MESNA 100 mg/mL 63323-734_80ed4c20-1e43-4fe2-bfd9-64652ba75471 63323-734 HUMAN PRESCRIPTION DRUG Pamidronate Disodium PAMIDRONATE DISODIUM INJECTION, SOLUTION INTRAVENOUS 20020519 ANDA ANDA076207 APP Pharmaceuticals, LLC PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 63323-735_80ed4c20-1e43-4fe2-bfd9-64652ba75471 63323-735 HUMAN PRESCRIPTION DRUG Pamidronate Disodium PAMIDRONATE DISODIUM INJECTION, SOLUTION INTRAVENOUS 20020519 ANDA ANDA076207 APP Pharmaceuticals, LLC PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 63323-738_1664c101-07b5-403a-a357-dd0e5bd13355 63323-738 HUMAN PRESCRIPTION DRUG Famotidine FAMOTIDINE INJECTION, SOLUTION INTRAVENOUS 20010719 ANDA ANDA075709 APP Pharmaceuticals, LLC FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63323-739_218774bb-b73e-4618-802f-a32ad18d7382 63323-739 HUMAN PRESCRIPTION DRUG Famotidine FAMOTIDINE INJECTION, SOLUTION INTRAVENOUS 20010315 ANDA ANDA075813 APP Pharmaceuticals, LLC FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63323-762_3988f974-5dfe-4afb-b1e1-4846c04a1553 63323-762 HUMAN PRESCRIPTION DRUG Topotecan Hydrochloride TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20101130 ANDA ANDA091089 Fresenius Kabi USA, LLC TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 63323-762_e86c2a1f-ba1e-44d1-9bd2-b3e88c04f760 63323-762 HUMAN PRESCRIPTION DRUG Topotecan Hydrochloride Topotecan Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20101129 ANDA ANDA091376 APP Pharmaceuticals, LLC TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 63323-763_44bb3dd5-e171-4887-b76c-90b96f8c356f 63323-763 HUMAN PRESCRIPTION DRUG Paclitaxel PACLITAXEL INJECTION, SOLUTION INTRAVENOUS 20090320 ANDA ANDA077574 APP Pharmaceuticals, LLC PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 63323-763_72e5e3b9-f242-4470-a434-7786ce73ad81 63323-763 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION INTRAVENOUS 20140815 ANDA ANDA090130 Fresenius Kabi USA, LLC PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 63323-772_7e0f6b72-8dd3-4f6d-ad16-80401fb8aba1 63323-772 HUMAN PRESCRIPTION DRUG LETROZOLE LETROZOLE TABLET, FILM COATED ORAL 20110604 ANDA ANDA090491 APP Pharmaceuticals, LLC LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 63323-877_a74cc23c-ad4e-4a11-b060-1a533f726cd2 63323-877 HUMAN PRESCRIPTION DRUG NebuPent PENTAMIDINE ISETHIONATE INHALANT RESPIRATORY (INHALATION) 20110215 NDA NDA019887 APP Pharmaceuticals, LLC PENTAMIDINE ISETHIONATE 300 mg/6mL Antiprotozoal [EPC] 63323-883_dd1cc92f-6089-407e-b0de-49316a3221c6 63323-883 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20000414 ANDA ANDA063277 Fresenius Kabi USA, LLC DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 63323-915_3bbce5c9-3dd0-4675-9a87-a2d786b435e6 63323-915 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 20000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63323-924_53233ea2-a9bb-47b6-8112-644d770db625 63323-924 HUMAN PRESCRIPTION DRUG Bacteriostatic Sodium Chloride SODIUM CHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20000808 ANDA ANDA088911 APP Pharmaceuticals, LLC SODIUM CHLORIDE 9 mg/mL 63323-961_f3f9de47-3d85-4d0c-a29e-1635cad3a970 63323-961 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION INTRAVENOUS 20140904 ANDA ANDA202923 Fresenius Kabi USA, LLC ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 63323-963_34b48ae3-745a-4491-80eb-4d90961d2d35 63323-963 HUMAN PRESCRIPTION DRUG Acetylcysteine Acetylcysteine INJECTION, SOLUTION INTRAVENOUS 20121109 ANDA ANDA200644 APP Pharmaceuticals, LLC ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 63323-965_904c7604-8bbc-4f22-a923-38c1513ba80a 63323-965 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19990927 ANDA ANDA088901 APP Pharmaceuticals, LLC POTASSIUM CHLORIDE 2 meq/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 63323-967_904c7604-8bbc-4f22-a923-38c1513ba80a 63323-967 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20000905 ANDA ANDA088908 APP Pharmaceuticals, LLC POTASSIUM CHLORIDE 2 meq/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 63323-970_6f6c3236-5149-4e44-a7a2-0638452b9a42 63323-970 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110531 NDA NDA090233 Fresenius Kabi USA, LLC BENZTROPINE MESYLATE 1 mg/mL Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 63347-112_28c7c78b-ffa1-4cd4-93c8-3c90e6f55d35 63347-112 HUMAN OTC DRUG RevitaDERM PSORIASIS COAL TAR OINTMENT TOPICAL 20111101 OTC MONOGRAPH FINAL part358H Blaine Labs Inc. COAL TAR 2 mL/100mL 63347-120_de1407a9-5a7b-4a76-9e7b-98d02f06b8f4 63347-120 HUMAN OTC DRUG RevitaDERM Wound Care BENZALKONIUM CHLORIDE GEL TOPICAL 20120524 OTC MONOGRAPH NOT FINAL part333A Blaine Labs Inc. BENZALKONIUM CHLORIDE 170 mg/89mL 63347-301_2ecfeef1-8736-42e8-b6bf-80b77d8d14b3 63347-301 HUMAN OTC DRUG EuCutaSol COAL TAR CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part358H Blaine Labs Inc. COAL TAR 2 g/100g 63347-400_40e0fce0-c43c-418a-a48b-ede2446b87d9 63347-400 HUMAN OTC DRUG Ortho-Nesic Menthol GEL TOPICAL 19950101 OTC MONOGRAPH FINAL part341 Blaine Labs Inc. CAMPHOR (SYNTHETIC); MENTHOL .2; 3.5 g/100g; g/100g 63347-401_9eb74595-8066-411a-8b42-5566eb6e2304 63347-401 HUMAN OTC DRUG Ortho-Nesic With Capsaicin Menthol GEL TOPICAL 19950101 OTC MONOGRAPH FINAL part341 Blaine Labs Inc. CAMPHOR (SYNTHETIC); MENTHOL .2; 3.5 g/100g; g/100g 63347-500_63608a75-73ca-4c1d-af57-b991e6fa70d4 63347-500 HUMAN OTC DRUG Tineacide Undecylenic Acid CREAM TOPICAL 19950101 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 10 g/100g 63347-501_63608a75-73ca-4c1d-af57-b991e6fa70d4 63347-501 HUMAN OTC DRUG Tineacide Physician Formula UNDECYLENIC ACID CREAM TOPICAL 19950101 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 13 g/100g 63347-502_786abfbd-0a1d-4d6e-be32-e7911d1e34dc 63347-502 HUMAN OTC DRUG TINEACIDE Antifungal MICONAZOLE NITRATE CREAM TOPICAL 20130601 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. MICONAZOLE NITRATE .7 g/35g 63347-511_7b053816-3736-4198-99e5-e35813836262 63347-511 HUMAN OTC DRUG TINEACIDE TOLNAFTATE LIQUID TOPICAL 20120919 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. TOLNAFTATE 140 mg/15mL 63347-520_93873bbf-6eae-4ce4-9a98-b9eeb69bdc77 63347-520 HUMAN OTC DRUG Tinaacide Athletes Foot UNDECYLENIC ACID CREAM TOPICAL 20120801 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 25 g/100g 63347-600_8805548f-fbc5-4013-ab04-ceaef3c73db1 63347-600 HUMAN OTC DRUG TERPENICOL ANTIFUNGAL UNDECYLENIC ACID LIQUID TOPICAL 20140401 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 25 g/100mL 63347-700_896b4f1e-2472-4d78-9900-677a4be27fab 63347-700 HUMAN OTC DRUG Verucide Physician Formula Salicyllic Acid LIQUID TOPICAL 20100101 OTC MONOGRAPH FINAL part358F Blaine Labs Inc. SALICYLIC ACID 17 mL/10mL 63347-800_3d70a928-845b-47fe-a9d7-f4595e8fa72e 63347-800 HUMAN OTC DRUG Vite20 UNDECYLENIC ACID CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 2 mL/20mL 63354-000_d5ef005b-d5f4-4c93-8a46-e5eda2b65530 63354-000 HUMAN OTC DRUG HAWAIIAN Tropic AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 10; 6 g/100g; g/100g; g/100g; g/100g 63354-001_643c11ac-3188-4433-abb5-b7b2f0d528ae 63354-001 HUMAN OTC DRUG Banana Boat Natural Reflect Sunscreen SPF 50 Plus TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20111228 OTC MONOGRAPH FINAL part352 Energizer Personal Care LLC TITANIUM DIOXIDE; ZINC OXIDE 2.8; 4 mL/100mL; mL/100mL 63354-002_c04bb279-fd16-4ca3-896c-c1ac8e75ea94 63354-002 HUMAN OTC DRUG Banana Boat Natural Reflect Sunscreen BABY SPF 50 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20111228 OTC MONOGRAPH FINAL part352 Energizer Personal Care LLC TITANIUM DIOXIDE; ZINC OXIDE 3.1; 4 mL/100mL; mL/100mL 63354-003_2276a7f8-f758-44b6-a582-57e3283ffb8a 63354-003 HUMAN OTC DRUG Banana Boat Natural Reflect Sunscreen KIDS SPF 50 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20111228 OTC MONOGRAPH FINAL part352 Energizer Personal Care LLC TITANIUM DIOXIDE; ZINC OXIDE 3.1; 4 mL/100mL; mL/100mL 63354-009_15df4f64-7dd6-4c3d-ae58-c84d51c1efd8 63354-009 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE AEROSOL, SPRAY TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 5; 5; 5; 2.5; 2 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g 63354-010_d3ab278d-a23a-4ebf-abd9-cfbeb5ee8097 63354-010 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SPRAY TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 6 g/100g; g/100g; g/100g; g/100g 63354-020_a0fef66b-a2ee-4002-b0b8-768b57bb4147 63354-020 HUMAN OTC DRUG HAWAIIAN Tropic AVOBENZONE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 2; 1.5 g/100g; g/100g; g/100g 63354-026_e07556b4-271d-4bca-a9b5-9babda2fb423 63354-026 HUMAN OTC DRUG Banana Boat AVOBENZONE, OCTOCRYLENE, OXYBENZONE OIL TOPICAL 20100928 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE .5; 1; .5 g/100g; g/100g; g/100g 63354-027_b074338d-27f1-49ea-a107-b80b9eb15b0e 63354-027 HUMAN OTC DRUG Banana Boat AVOBENZONE, OCTOCRYLENE, OXYBENZONE OIL TOPICAL 20101130 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE .5; 2; 1.5 g/100g; g/100g; g/100g 63354-028_624281af-9336-4df8-8d75-cb5dcdc2f9aa 63354-028 HUMAN OTC DRUG Meijer AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE .5; 2; 1.5 mL/100mL; mL/100mL; mL/100mL 63354-031_4402981e-e51c-4a17-bc8f-d510d194828d 63354-031 HUMAN OTC DRUG Banana Boat OCTINOXATE, PADIMATE O OIL TOPICAL 20100928 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC OCTINOXATE; PADIMATE O 2; 1.4 g/100g; g/100g 63354-041_75c9d60d-9678-4d39-92de-321ffde53bba 63354-041 HUMAN OTC DRUG Banana Boat OCTINOXATE, OXYBENZONE, PADIMATE O OIL TOPICAL 20100928 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC OCTINOXATE; OXYBENZONE; PADIMATE O 3.5; 1; 8 g/100g; g/100g; g/100g 63354-050_4e00f3f0-eaa9-4a56-bc2b-85058ffc5812 63354-050 HUMAN PRESCRIPTION DRUG BANANA BOAT TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20121003 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC TITANIUM DIOXIDE; ZINC OXIDE 3.1; 4 g/100g; g/100g 63354-051_47e2c5e7-666c-4f76-a93d-40bad2e35f0a 63354-051 HUMAN OTC DRUG BANANA BOAT TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20121004 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC TITANIUM DIOXIDE; ZINC OXIDE 3.1; 4 g/100g; g/100g 63354-093_ef1ba548-3eac-49f4-ad81-fb40973b8094 63354-093 HUMAN OTC DRUG Banana Boat OCTINOXATE, OCTOCRYLENE, OXYBENZONE, PADIMATE O OIL TOPICAL 20101202 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC OCTINOXATE; OCTOCRYLENE; OXYBENZONE; PADIMATE O 5; 5; 3; 8 g/100g; g/100g; g/100g; g/100g 63354-101_9f26b841-89cf-4c17-b942-e6e6802ae403 63354-101 HUMAN OTC DRUG Hawaiian Tropic SPF 15 AVOBENZONE,OCTISALATE,OCTOCRYLENE LOTION TOPICAL 20140723 OTC MONOGRAPH NOT FINAL part352 ENERGIZER PERSONAL CARE LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 3; 2 g/100g; g/100g; g/100g 63354-110_5940dd78-42e2-4b95-b24f-40a5436d654d 63354-110 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 6; 4 g/100g; g/100g; g/100g 63354-111_7ccb4cdf-ca56-4ce3-b96f-9ef160176963 63354-111 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 6; 4 g/100g; g/100g; g/100g 63354-125_f919958b-5972-4a62-bc35-eae5f8df28b3 63354-125 HUMAN OTC DRUG HAWAIIAN TROPIC OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20100928 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC OCTOCRYLENE; OXYBENZONE 1.8; 1 g/100g; g/100g 63354-126_1133c0f5-1e40-43be-a946-6d41c26feeb3 63354-126 HUMAN OTC DRUG HAWAIIAN TROPIC OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20100928 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC OCTOCRYLENE; OXYBENZONE 2; 1.5 g/100g; g/100g 63354-130_9078a182-e8ca-457b-b50f-9dd181cdb8ea 63354-130 HUMAN OTC DRUG HAWAIIAN Tropic Dry Clear Sunscreen Broad Spectrum SPF 12 water resistant AVOBENZONE, OCTOCRYLENE SPRAY TOPICAL 20130514 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE 30; 50 mg/mL; mg/mL 63354-140_fcedea11-dfdb-4e16-a5a0-d4d21d115a50 63354-140 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20110826 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 10; 6 g/100g; g/100g; g/100g 63354-150_7efb691e-a527-44a6-9884-43bd7d18874f 63354-150 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20110826 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 10; 6 g/100g; g/100g; g/100g 63354-160_4ad84554-7ab4-4aff-9ee0-0cac6c9493bc 63354-160 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20110826 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 10; 6 g/100g; g/100g; g/100g 63354-161_dde57ae8-e30d-40a3-95ce-c2bf556edcfc 63354-161 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20110826 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 10; 6 g/100g; g/100g; g/100g 63354-162_53326dea-7c1c-4976-946e-b734dbe291c6 63354-162 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20110826 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 10; 6 g/100g; g/100g; g/100g 63354-163_1019d88e-9475-4c6a-9938-52939fe27111 63354-163 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20110826 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 10; 6 g/100g; g/100g; g/100g 63354-200_ea061e27-53c0-4a0a-9007-7c00666810f2 63354-200 HUMAN OTC DRUG HAWAIIAN Tropic AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 5; 3 g/100g; g/100g; g/100g 63354-210_5ee8533e-51e6-4c94-ba56-5aee5cf8d5ef 63354-210 HUMAN OTC DRUG HAWAIIAN TROPIC OCTOCRYLENE, OXYBENZONE OIL TOPICAL 20110826 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE 4; 2 g/100g; g/100g 63354-215_b58e42ab-fd77-4d7b-a3f9-094b6c807304 63354-215 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2.5; 8; 3.5 g/100g; g/100g; g/100g 63354-216_33ff3b3f-5ed7-4402-8585-17a3efcfbd16 63354-216 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2.5; 8; 3.5 g/100g; g/100g; g/100g 63354-218_20ed6f9e-1aff-4630-807b-cc1a7040c27c 63354-218 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2.5; 8; 3.5 g/100g; g/100g; g/100g 63354-219_c3b63ba1-9941-4993-b3d9-7241a0470f4a 63354-219 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2.5; 8; 3.5 g/100g; g/100g; g/100g 63354-220_a1226aad-2d11-4bc3-adfa-76fd72f54a45 63354-220 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE OIL TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 3; 5; 4; 3 g/100g; g/100g; g/100g; g/100g 63354-222_10240754-7773-4ca9-9348-ba3ee6c55e94 63354-222 HUMAN OTC DRUG HAWAIIAN TROPIC AVOBENZONE, OCTOCRYLENE, OXYBENZONE OIL TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE .5; 3.5; 1.5 g/100g; g/100g; g/100g 63354-230_fa190942-437b-41cf-85b2-656881acf810 63354-230 HUMAN OTC DRUG Banana Boat Protect and Hydrate SPF 30 AVOBENZONE,HOMOSALATE,OCTOCRYLENE SPRAY TOPICAL 20140408 OTC MONOGRAPH NOT FINAL part352 ENERGIZER PERSONAL CARE LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE 2; 7; 5 g/100g; g/100g; g/100g 63354-250_011c41ee-2605-4ffb-b433-67e6090ca1c0 63354-250 HUMAN OTC DRUG Banana Boat Protect and Hydrate SPF 50 Plus AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE SPRAY TOPICAL 20140408 OTC MONOGRAPH NOT FINAL part352 ENERGIZER PERSONAL CARE LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 5 g/100g; g/100g; g/100g; g/100g 63354-260_e652d78f-00f4-4806-9696-fbc999c116c1 63354-260 HUMAN OTC DRUG HAWAIIAN TROPIC AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE OIL TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 5; 5; 2.4; 4 g/100g; g/100g; g/100g; g/100g; g/100g 63354-280_fef11e1a-42aa-4928-bab3-086d125ae375 63354-280 HUMAN OTC DRUG Banana Boat Mens SPF 30 Avobenzone,Homosalate,Octisalate,Octocrylene,Oxybenzone LOTION TOPICAL 20140326 OTC MONOGRAPH NOT FINAL part352 ENERGIZER PERSONAL CARE, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.2; 10; 5; .8; 4 g/100g; g/100g; g/100g; g/100g; g/100g 63354-290_e612f5dd-95a6-4e17-ae73-ec2a816c33b0 63354-290 HUMAN OTC DRUG Banana Boat Mens SPF 50 Plus Avobenzone,Homosalate,Octisalate,Octocrylene,Oxybenzone LOTION TOPICAL 20140812 OTC MONOGRAPH NOT FINAL part352 ENERGIZER PERSONAL CARE, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 15; 5; 1.2; 6 g/100g; g/100g; g/100g; g/100g; g/100g 63354-291_d53aafb3-6575-4299-83b8-9679ee08b4d8 63354-291 HUMAN OTC DRUG HAWAIIAN Tropic AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20100928 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE .9; 3; 3 g/100g; g/100g; g/100g 63354-292_ab1a2af1-8d03-4c06-9f01-5d20da3d8b88 63354-292 HUMAN OTC DRUG HAWAIIAN Tropic AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20100928 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 6; 4 g/100g; g/100g; g/100g 63354-300_43f62e90-5e0d-4708-bc1c-7f108c2f104b 63354-300 HUMAN OTC DRUG Hawaiian Tropic AVOBENZONE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 10; 6 g/100g; g/100g; g/100g 63354-300_b613454c-b9ec-40b9-a019-260b2a4fddb4 63354-300 HUMAN OTC DRUG Hawaiian Tropic AVOBENZONE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 10; 6 g/100g; g/100g; g/100g 63354-303_80bc480b-6445-4c34-bea5-18e98c1961be 63354-303 HUMAN OTC DRUG HAWAIIAN Tropic AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20100928 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 5; 3 g/100g; g/100g; g/100g 63354-315_eab341c2-5a12-402a-b4a5-1f1a5a9b5979 63354-315 HUMAN OTC DRUG HAWAIIAN Tropic AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20100930 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 3; 3 g/100g; g/100g; g/100g 63354-316_f57fb8a3-9b69-4ccb-92ae-31ae32ed661b 63354-316 HUMAN OTC DRUG HAWAIIAN Tropic AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20100930 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 5; 4 g/100g; g/100g; g/100g 63354-320_148477be-05ee-4373-9db3-cbd1ada80d3e 63354-320 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 15; 5; 1.25; 6 g/100g; g/100g; g/100g; g/100g; g/100g 63354-321_84383694-4ab0-4a14-9b81-bd2da572c78d 63354-321 HUMAN OTC DRUG HAWAIIAN TROPIC AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 5; 3 g/100g; g/100g; g/100g 63354-322_46b1fa78-6733-4dcc-882c-c8d938a14caa 63354-322 HUMAN OTC DRUG HAWAIIAN Tropic LIDOCAINE GEL TOPICAL 20100928 OTC MONOGRAPH FINAL part348 Energizer Personal Care LLC LIDOCAINE .8 g/100g 63354-330_be4f2118-dcfb-4fcb-a4a1-93781e05e597 63354-330 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1; 10; 5; .8; 4 g/100g; g/100g; g/100g; g/100g; g/100g 63354-331_06c8dd7c-81d7-4450-9317-ddfc457282a0 63354-331 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1; 10; 5; .8; 4 g/100g; g/100g; g/100g; g/100g; g/100g 63354-350_a880ad87-cce2-4760-ab7c-0d7f2b42f71d 63354-350 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE OIL TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 3; 3 g/100g; g/100g; g/100g 63354-351_f717e81b-e499-44cc-a58c-52325e9b3c61 63354-351 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120104 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 1; 6; .8; 2 g/100g; g/100g; g/100g; g/100g 63354-352_7ea0f79b-caf8-4482-a490-7b6495c366f3 63354-352 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 1; 6; .8; 2 g/100g; g/100g; g/100g; g/100g 63354-360_4098f2ea-c567-40cf-842f-75a8ddb0348b 63354-360 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE OIL TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE .5; 1; .5 g/100g; g/100g; g/100g 63354-370_726b9c5f-3673-4f28-8522-d42492c8edc4 63354-370 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 2.5 g/100g; g/100g; g/100g; g/100g 63354-371_d4d5f861-4063-4d0f-8cfa-9522b9ece0e4 63354-371 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20120104 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 5; 3 g/100g; g/100g; g/100g 63354-372_d2b00356-4e2d-434f-8446-59b71d19a2ed 63354-372 HUMAN OTC DRUG Banana Boat Mens SPF 30 Avobenzone,Homosalate,Octocrylene SPRAY TOPICAL 20140331 OTC MONOGRAPH NOT FINAL part352 ENERGIZER PERSONAL CARE LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE 2; 7; 5 g/100g; g/100g; g/100g 63354-390_bb5e046e-3edb-4057-b2be-74847b75f573 63354-390 HUMAN OTC DRUG Banana Boat Mens SPF 50 Plus Avobenzone,Homosalate,Octisalate,Octocrylene SPRAY TOPICAL 20140331 OTC MONOGRAPH NOT FINAL part352 ENERGIZER PERSONAL CARE LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 5 g/100g; g/100g; g/100g; g/100g 63354-400_add09d64-b781-4f38-b404-8a9ff8923ad2 63354-400 HUMAN OTC DRUG Hawaiian Tropic AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 1; 15; 4; 6 g/100g; g/100g; g/100g; g/100g 63354-401_b6089d23-a26b-4560-b9bb-86d3dfc2a27a 63354-401 HUMAN OTC DRUG HAWAIIAN Tropic AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE .5; 3.5; 1.5 g/100g; g/100g; g/100g 63354-430_b31f6439-a778-462d-a6b7-9194a6f66781 63354-430 HUMAN OTC DRUG HAWAIIAN TROPIC AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 1; 15; 4; 6 g/100g; g/100g; g/100g; g/100g 63354-450_a9dce2bd-626c-44c1-8bb4-f676b7cd2d73 63354-450 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20120104 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 10; 6 g/100g; g/100g; g/100g; g/100g 63354-451_ed8da142-cc7b-4b18-9022-a63fb437e9b4 63354-451 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20120104 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 10; 6 g/100g; g/100g; g/100g; g/100g 63354-452_19f68c3b-c07d-4ee1-beb1-0f4a41e84b73 63354-452 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 10; 6 g/100g; g/100g; g/100g; g/100g 63354-600_b6c3dba1-25a6-4c56-8c90-d262738d99f1 63354-600 HUMAN OTC DRUG HAWAIIAN TROPIC AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE .5; 1 g/100g; g/100g 63354-615_74fa66f4-e2cc-4796-9e87-679b1047e097 63354-615 HUMAN OTC DRUG HAWAIIAN TROPIC OXYBENZONE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 2; 2 g/100g; g/100g; g/100g 63354-617_4f902016-dcd9-4e2a-bfa6-d118114cab94 63354-617 HUMAN OTC DRUG HAWAIIAN TROPIC AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 5; 3 g/100g; g/100g; g/100g 63354-624_70342727-fb95-4616-9d15-2a11ef5ae173 63354-624 HUMAN OTC DRUG HAWAIIAN TROPIC AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE .5; .7 g/100g; g/100g 63354-625_8bf401d9-b720-4fba-9837-8586861e862d 63354-625 HUMAN OTC DRUG HAWAIIAN TROPIC AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE .5; 1 g/100g; g/100g 63354-730_3ddb1925-6337-440c-8e69-c7287d82a804 63354-730 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 15; 5; 1.2; 6 g/100g; g/100g; g/100g; g/100g; g/100g 63354-780_ae6a4711-751c-4bc8-ab12-f3e74d8fe9b8 63354-780 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20120104 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g 63354-781_a564965d-f34e-4a28-a593-a1debfb40c5c 63354-781 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20120104 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g 63354-782_c407ab8a-d824-473f-b198-ea8f3f3332a8 63354-782 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20120104 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g 63354-783_b2ece6ee-836b-4ed0-a2bc-6c80f892f523 63354-783 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SPRAY TOPICAL 20110725 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 6 g/100g; g/100g; g/100g; g/100g 63354-800_f597c27b-a8d4-46f2-977a-3f0627c786c3 63354-800 HUMAN OTC DRUG Hawaiian Tropic AVOBENZONE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 10; 6 g/100g; g/100g; g/100g 63354-871_fcad74b4-54ca-4a2d-ba8c-c689ed2b50ec 63354-871 HUMAN OTC DRUG BANANA BOAT HOMOSALATE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE LOTION TOPICAL 20120104 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC HOMOSALATE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 15; 7.5; 5; 2.4 g/100g; g/100g; g/100g; g/100g 63354-900_0cd33545-9bdd-44cd-b5fe-e9b3911a1e36 63354-900 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE AEROSOL, SPRAY TOPICAL 20120710 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 7.4; 3 g/100g; g/100g; g/100g 63354-910_b7030ca8-3e50-45b2-94aa-48cbd67ac3a2 63354-910 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE AEROSOL, SPRAY TOPICAL 20120710 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 10; 5 g/100g; g/100g; g/100g 63354-920_cdf287e7-b5cc-4c6e-a665-7d4dc865b96d 63354-920 HUMAN OTC DRUG HAWAIIAN Tropic OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC OCTOCRYLENE; OXYBENZONE 8; 3.5 g/100g; g/100g 63354-921_cb61b417-7b60-434f-a0c2-b46498c131ce 63354-921 HUMAN OTC DRUG HAWAIIAN Tropic OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC OCTOCRYLENE; OXYBENZONE 8; 3.5 g/100g; g/100g 63354-930_cc3be1bd-2d78-4c87-bac1-f732a7cfdd37 63354-930 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20111229 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 7.7; 3 g/100g; g/100g; g/100g 63354-931_c8124d8a-0043-4438-8078-4af3513c1ac6 63354-931 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20111229 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 7.7; 3 g/100g; g/100g; g/100g 63354-932_a41b7c4e-28bd-4bc8-b97e-d1e17dfb91af 63354-932 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20111229 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 7.7; 3 g/100g; g/100g; g/100g 63354-940_f88c1727-ade1-4e0b-97d9-3c58b7f83db9 63354-940 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20111229 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 10; 5 g/100g; g/100g; g/100g 63354-941_a4d19b2b-e75c-4da9-a49f-36106dc0799c 63354-941 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20111229 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 10; 5 g/100g; g/100g; g/100g 63354-942_9f0f8ce7-064a-4f7b-b7a3-ae92dcca3fc2 63354-942 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20111229 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 10; 5 g/100g; g/100g; g/100g 63354-943_3118aeea-31a7-4066-a6b1-4617a8e96ee2 63354-943 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20111229 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 10; 5 g/100g; g/100g; g/100g 63354-950_c3795dd1-8cf7-4c46-9cb7-cf66c82177a5 63354-950 HUMAN OTC DRUG HAWAIIAN Tropic AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 7.7; 3 g/100g; g/100g; g/100g 63354-951_e124ac4a-5a60-4256-94ca-dcbd06f9d491 63354-951 HUMAN OTC DRUG HAWAIIAN Tropic AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 7.7; 3 g/100g; g/100g; g/100g 63354-952_ccdbb7f0-c6df-46f4-9bfd-03a6215ce6f5 63354-952 HUMAN OTC DRUG HAWAIIAN Tropic AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 7.7; 3 g/100g; g/100g; g/100g 63354-960_bff00a38-3c57-4cbd-aa30-db3d01e938c0 63354-960 HUMAN OTC DRUG HAWAIIAN Tropic AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 10; 5 g/100g; g/100g; g/100g 63354-980_c22333c9-e47a-45d2-be2b-f1e5556def86 63354-980 HUMAN OTC DRUG HAWAIIAN TROPIC OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20100928 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC OCTOCRYLENE; OXYBENZONE 1; .5 g/100g; g/100g 63354-990_f332c4db-ea69-42b2-bb75-f74b3b53edfe 63354-990 HUMAN OTC DRUG HAWAIIAN Tropic AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 8; 6 g/100g; g/100g; g/100g 63354-992_e2f9d47e-f9fb-4dfa-b141-9f3ad56e3006 63354-992 HUMAN OTC DRUG Hawaiian Tropic Dry SPF 30 AVOBENZONE,OCTOCRYLENE,OXYBENZONE SPRAY TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part352 ENERGIZER PERSONAL CARE LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 7.7; 3 g/100g; g/100g; g/100g 63354-998_61d7554e-610b-410e-a203-a52abd09aa80 63354-998 HUMAN OTC DRUG WET ONES Benzethonium Chloride SWAB TOPICAL 20071001 OTC MONOGRAPH NOT FINAL part333A Energizer Personal Care LLC BENZETHONIUM CHLORIDE .3 1/1001 63354-999_9c0891d1-ffae-45ef-843d-b4f3d8f87562 63354-999 HUMAN OTC DRUG WET ONES Benzethonium Chloride SWAB TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Energizer Personal Care LLC BENZETHONIUM CHLORIDE .3 1/1001 63377-024_7c3da1dd-8ad0-422b-882b-2591ea6c00ff 63377-024 HUMAN OTC DRUG GERM FREE 24 PLUS Hand Sanitizer and Protectant BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part333E Coating Systems Laboratories, Inc. BENZALKONIUM CHLORIDE 10 mg/100mL 63385-001_2a43aa11-0a3b-4370-9d7d-0cc8c033a317 63385-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19910101 UNAPPROVED MEDICAL GAS Ferguson Industrial Gases dba Ferguson Enterprises OXYGEN 99 L/100L 63395-201_e5a85e80-046c-11df-ae8f-0002a5d5c51b 63395-201 HUMAN PRESCRIPTION DRUG Evoxac cevimeline hydrochloride CAPSULE ORAL 20000112 NDA NDA020989 Daiichi Sankyo Pharma Development CEVIMELINE HYDROCHLORIDE 30 mg/1 Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 63398-1072_670ca6ff-5237-4e6f-b33a-31957a29bf25 63398-1072 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19820101 UNAPPROVED MEDICAL GAS A.V. Pulmonary Care OXYGEN 99 L/100L 63401-681_871d31a5-0d59-48c1-8d5d-ba31f4182a9f 63401-681 HUMAN OTC DRUG SANITACK SANITIZING WIPES PLUS BENZALKONIUM CHLORIDE CLOTH TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part333E CAN Creations BENZALKONIUM CHLORIDE .01417 g/1 63402-190_9168472d-40b4-4e1a-9471-2c8fe35c0894 63402-190 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 Sunovion ESZOPICLONE 1 mg/1 CIV 63402-191_9168472d-40b4-4e1a-9471-2c8fe35c0894 63402-191 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 Sunovion ESZOPICLONE 2 mg/1 CIV 63402-193_9168472d-40b4-4e1a-9471-2c8fe35c0894 63402-193 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 Sunovion ESZOPICLONE 3 mg/1 CIV 63402-202_1a82e4c5-fa70-4e0e-a7f9-cb78d5dc54c3 63402-202 HUMAN PRESCRIPTION DRUG Aptiom ESLICARBAZEPINE ACETATE TABLET ORAL 20131108 NDA NDA022416 Sunovion Pharmaceuticals Inc. ESLICARBAZEPINE ACETATE 200 mg/1 63402-204_1a82e4c5-fa70-4e0e-a7f9-cb78d5dc54c3 63402-204 HUMAN PRESCRIPTION DRUG Aptiom ESLICARBAZEPINE ACETATE TABLET ORAL 20131108 NDA NDA022416 Sunovion Pharmaceuticals Inc. ESLICARBAZEPINE ACETATE 400 mg/1 63402-206_1a82e4c5-fa70-4e0e-a7f9-cb78d5dc54c3 63402-206 HUMAN PRESCRIPTION DRUG Aptiom ESLICARBAZEPINE ACETATE TABLET ORAL 20131108 NDA NDA022416 Sunovion Pharmaceuticals Inc. ESLICARBAZEPINE ACETATE 600 mg/1 63402-208_1a82e4c5-fa70-4e0e-a7f9-cb78d5dc54c3 63402-208 HUMAN PRESCRIPTION DRUG Aptiom ESLICARBAZEPINE ACETATE TABLET ORAL 20131108 NDA NDA022416 Sunovion Pharmaceuticals Inc. ESLICARBAZEPINE ACETATE 800 mg/1 63402-248_1a82e4c5-fa70-4e0e-a7f9-cb78d5dc54c3 63402-248 HUMAN PRESCRIPTION DRUG Aptiom ESLICARBAZEPINE ACETATE KIT ORAL 20131108 NDA NDA022416 Sunovion Pharmaceuticals Inc. 63402-302_c785eb3a-8080-4bc1-9d1e-4376222cc401 63402-302 HUMAN PRESCRIPTION DRUG Latuda lurasidone hydrochloride TABLET, FILM COATED ORAL 20111207 NDA NDA200603 Sunovion Pharmaceuticals Inc. LURASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 63402-304_c785eb3a-8080-4bc1-9d1e-4376222cc401 63402-304 HUMAN PRESCRIPTION DRUG Latuda lurasidone hydrochloride TABLET, FILM COATED ORAL 20101028 NDA NDA200603 Sunovion Pharmaceuticals Inc. LURASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 63402-306_c785eb3a-8080-4bc1-9d1e-4376222cc401 63402-306 HUMAN PRESCRIPTION DRUG Latuda lurasidone hydrochloride TABLET, FILM COATED ORAL 20130712 NDA NDA200603 Sunovion Pharmaceuticals Inc. LURASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 63402-308_c785eb3a-8080-4bc1-9d1e-4376222cc401 63402-308 HUMAN PRESCRIPTION DRUG Latuda lurasidone hydrochloride TABLET, FILM COATED ORAL 20101028 NDA NDA200603 Sunovion Pharmaceuticals Inc. LURASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 63402-312_c785eb3a-8080-4bc1-9d1e-4376222cc401 63402-312 HUMAN PRESCRIPTION DRUG Latuda lurasidone hydrochloride TABLET, FILM COATED ORAL 20120426 NDA NDA200603 Sunovion Pharmaceuticals Inc. LURASIDONE HYDROCHLORIDE 120 mg/1 Atypical Antipsychotic [EPC] 63402-510_ef63a270-9603-4e65-9215-999fcd3ab550 63402-510 HUMAN PRESCRIPTION DRUG Xopenex HFA levalbuterol tartrate AEROSOL, METERED ORAL 20051201 NDA NDA021730 Sunovion Pharmaceuticals Inc. LEVALBUTEROL TARTRATE 45 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 63402-511_3b2eebaa-6575-4a02-812f-81567664c656 63402-511 HUMAN PRESCRIPTION DRUG Xopenex levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20020301 NDA NDA020837 Sunovion Pharmaceuticals Inc. LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 63402-512_3b2eebaa-6575-4a02-812f-81567664c656 63402-512 HUMAN PRESCRIPTION DRUG Xopenex levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 19990401 NDA NDA020837 Sunovion Pharmaceuticals Inc. LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 63402-513_3b2eebaa-6575-4a02-812f-81567664c656 63402-513 HUMAN PRESCRIPTION DRUG Xopenex levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 19990401 NDA NDA020837 Sunovion Pharmaceuticals Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 63402-515_f42b682e-7d4f-4033-b006-b75346d6cfaa 63402-515 HUMAN PRESCRIPTION DRUG Xopenex levalbuterol hydrochloride SOLUTION, CONCENTRATE RESPIRATORY (INHALATION) 20040801 NDA NDA020837 Sunovion Pharmaceuticals Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/.5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 63402-701_8bcb22f0-1619-4d12-b85b-8b7f32b3d9e1 63402-701 HUMAN PRESCRIPTION DRUG Omnaris ciclesonide SPRAY NASAL 20080301 NDA NDA022004 Sunovion Pharmaceuticals Inc. CICLESONIDE 50 ug/1 63402-711_ca8d58e0-1f6b-4277-9ab5-241153f1b32e 63402-711 HUMAN PRESCRIPTION DRUG Alvesco ciclesonide AEROSOL, METERED RESPIRATORY (INHALATION) 20081001 NDA NDA021658 Sunovion Pharmaceuticals Inc. CICLESONIDE 80 ug/1 63402-712_ca8d58e0-1f6b-4277-9ab5-241153f1b32e 63402-712 HUMAN PRESCRIPTION DRUG Alvesco ciclesonide AEROSOL, METERED RESPIRATORY (INHALATION) 20081001 NDA NDA021658 Sunovion Pharmaceuticals Inc. CICLESONIDE 160 ug/1 63402-737_34f65bba-0a07-48cb-9288-4eaf05947c5c 63402-737 HUMAN PRESCRIPTION DRUG Zetonna ciclesonide AEROSOL, METERED NASAL 20120730 NDA NDA202129 Sunovion Pharmaceuticals Inc. CICLESONIDE 37 ug/1 63402-911_3a760f76-1118-48ae-a535-03d0be82d063 63402-911 HUMAN PRESCRIPTION DRUG Brovana arformoterol tartrate SOLUTION RESPIRATORY (INHALATION) 20070401 NDA NDA021912 Sunovion Pharmaceuticals Inc. ARFORMOTEROL TARTRATE 15 ug/2mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 63404-0910_dcf3823e-da6a-4c48-8d3b-25fa341fd8c1 63404-0910 HUMAN OTC DRUG SprinJene Fresh Boost Sodium Fluoride GEL, DENTIFRICE DENTAL 20141010 OTC MONOGRAPH FINAL part355 Health and Natural Beauty USA Corp SODIUM FLUORIDE 1.5 mg/g 63404-1116_d3e04ab9-7595-4db3-b881-7836377cc49c 63404-1116 HUMAN OTC DRUG SprinJene White Boost Sodium Fluoride PASTE, DENTIFRICE DENTAL 20141010 OTC MONOGRAPH FINAL part355 Health and Natural Beauty USA Corp SODIUM FLUORIDE 1.5 mg/g 63418-0001_f5d3ed7a-123e-47ad-98d0-201452c00324 63418-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990601 UNAPPROVED MEDICAL GAS Rogers Pharmacy OXYGEN 99 L/100L 63433-122_46dc0604-585b-463c-bd9f-7c959fb7e94a 63433-122 HUMAN OTC DRUG DHC Body Sunscreen Milk Titanium Dioxide LOTION TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part352 DHC USA Incorporated TITANIUM DIOXIDE 210 mg/2mL 63433-200_8ee61495-ebb1-49f0-9ba2-5e7ef50a7105 63433-200 HUMAN OTC DRUG DHC BB Foundation Natural Ocher 02 Titanium dioxide and Zinc oxide CREAM TOPICAL 20120611 OTC MONOGRAPH FINAL part352 DHC USA Incorporated TITANIUM DIOXIDE; ZINC OXIDE 4.98; 9.66 mg/.23g; mg/.23g 63433-207_9031b760-4a83-4852-b0aa-2e6e80f7b31b 63433-207 HUMAN OTC DRUG DHC Camu Camu White Day Milk Octinoxate LOTION TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 DHC USA Incorporated OCTINOXATE 75 mg/mL 63433-222_24c114b4-fed5-4992-a88c-4379e605a7ff 63433-222 HUMAN OTC DRUG DHC Camu Camu White Day Milk Octinoxate and Oxybenzone LOTION TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 DHC USA Incorporated OCTINOXATE; OXYBENZONE 35; 5 mg/.5mL; mg/.5mL 63433-223_be71e87d-f3e3-4be2-a966-b48a00d8cc45 63433-223 HUMAN OTC DRUG DHC BB Foundation Natural Ocher 01 Titanium dioxide and Zinc oxide CREAM TOPICAL 20120611 OTC MONOGRAPH FINAL part352 DHC USA Incorporated TITANIUM DIOXIDE; ZINC OXIDE 4.98; 9.66 mg/.23g; mg/.23g 63433-451_b8201890-9023-4602-a543-992663e7b854 63433-451 HUMAN OTC DRUG DHC White Sunscreen Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20050501 OTC MONOGRAPH NOT FINAL part352 DHC USA Incorporated TITANIUM DIOXIDE; ZINC OXIDE 50; 100 mg/g; mg/g 63433-803_4408f886-704d-48c1-be33-036e9e9a5da9 63433-803 HUMAN OTC DRUG DHC Hand Triclosan LIQUID TOPICAL 20060621 OTC MONOGRAPH NOT FINAL part333E DHC USA Incorporated TRICLOSAN 3.1 mg/mL 63433-894_9d5524db-9655-41bc-8fbe-a57f1c47f588 63433-894 HUMAN OTC DRUG DHC Salicylic Acne Wash Salicylic Acid LOTION TOPICAL 20110801 OTC MONOGRAPH FINAL part333D DHC USA Incorporated SALICYLIC ACID 30 mg/1.5mL 63433-895_e11a43db-d4e9-44df-b61d-0aa5a65cb79a 63433-895 HUMAN OTC DRUG DHC Salicylic Acne Toner Salicylic Acid LIQUID TOPICAL 20110801 OTC MONOGRAPH FINAL part333D DHC USA Incorporated SALICYLIC ACID 50.5 mg/2.5mL 63433-896_b609a4e0-8162-4eb2-98ac-3e57e670e4a5 63433-896 HUMAN OTC DRUG DHC Salicylic Face Milk Salicylic Acid LOTION TOPICAL 20110801 OTC MONOGRAPH FINAL part358H DHC USA Incorporated SALICYLIC ACID 20 mg/mL 63433-897_e6ad9c0e-db80-472c-a3c8-bb1f7f3e43a4 63433-897 HUMAN OTC DRUG DHC Acne Spot Therapy Sulfur CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part333D DHC USA Incorporated SULFUR 6 mg/.2g 63459-101_dc83f392-39f9-4e5a-b847-96a46e97c6da 63459-101 HUMAN PRESCRIPTION DRUG PROVIGIL modafinil TABLET ORAL 19981224 NDA NDA020717 Cephalon, Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 63459-177_bcd20457-429a-4a01-9fd2-6e5743d6f44a 63459-177 HUMAN PRESCRIPTION DRUG SYNRIBO omacetaxine mepesuccinate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20121119 NDA NDA203585 Cephalon, Inc. OMACETAXINE MEPESUCCINATE 3.5 mg/mL 63459-201_dc83f392-39f9-4e5a-b847-96a46e97c6da 63459-201 HUMAN PRESCRIPTION DRUG PROVIGIL modafinil TABLET ORAL 19981224 NDA NDA020717 Cephalon, Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 63459-205_4c44a52b-bbf6-4294-84e4-6c823d7069b2 63459-205 HUMAN PRESCRIPTION DRUG Nuvigil Armodafinil TABLET ORAL 20090526 NDA NDA021875 Cephalon, Inc. ARMODAFINIL 50 mg/1 CIV 63459-215_4c44a52b-bbf6-4294-84e4-6c823d7069b2 63459-215 HUMAN PRESCRIPTION DRUG Nuvigil Armodafinil TABLET ORAL 20090526 NDA NDA021875 Cephalon, Inc. ARMODAFINIL 150 mg/1 CIV 63459-220_4c44a52b-bbf6-4294-84e4-6c823d7069b2 63459-220 HUMAN PRESCRIPTION DRUG Nuvigil Armodafinil TABLET ORAL 20140220 NDA NDA021875 Cephalon, Inc. ARMODAFINIL 200 mg/1 CIV 63459-225_4c44a52b-bbf6-4294-84e4-6c823d7069b2 63459-225 HUMAN PRESCRIPTION DRUG Nuvigil Armodafinil TABLET ORAL 20090526 NDA NDA021875 Cephalon, Inc. ARMODAFINIL 250 mg/1 CIV 63459-390_951b095d-0ea1-44d5-a1e9-8f3a00b013e1 63459-390 HUMAN PRESCRIPTION DRUG TREANDA bendamustine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080320 NDA NDA022249 Cephalon, Inc. BENDAMUSTINE HYDROCHLORIDE 25 mg/5mL Alkylating Activity [MoA],Alkylating Drug [EPC] 63459-391_951b095d-0ea1-44d5-a1e9-8f3a00b013e1 63459-391 HUMAN PRESCRIPTION DRUG TREANDA bendamustine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080320 NDA NDA022249 Cephalon, Inc. BENDAMUSTINE HYDROCHLORIDE 100 mg/20mL Alkylating Activity [MoA],Alkylating Drug [EPC] 63459-395_d0840b8c-54c5-4d78-b543-cea91eb65733 63459-395 HUMAN PRESCRIPTION DRUG TREANDA bendamustine hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20141105 NDA NDA022249 Cephalon, Inc. BENDAMUSTINE HYDROCHLORIDE 45 mg/.5mL Alkylating Activity [MoA],Alkylating Drug [EPC] 63459-396_d0840b8c-54c5-4d78-b543-cea91eb65733 63459-396 HUMAN PRESCRIPTION DRUG TREANDA bendamustine hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20141105 NDA NDA022249 Cephalon, Inc. BENDAMUSTINE HYDROCHLORIDE 180 mg/2mL Alkylating Activity [MoA],Alkylating Drug [EPC] 63459-402_3363330b-7427-4191-942b-c55a433ab114 63459-402 HUMAN PRESCRIPTION DRUG GABITRIL tiagabine hydrochloride TABLET ORAL 19971103 NDA NDA020646 Cephalon, Inc. TIAGABINE HYDROCHLORIDE 2 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63459-404_3363330b-7427-4191-942b-c55a433ab114 63459-404 HUMAN PRESCRIPTION DRUG GABITRIL tiagabine hydrochloride TABLET ORAL 19971103 NDA NDA020646 Cephalon, Inc. TIAGABINE HYDROCHLORIDE 4 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63459-412_3363330b-7427-4191-942b-c55a433ab114 63459-412 HUMAN PRESCRIPTION DRUG GABITRIL tiagabine hydrochloride TABLET ORAL 19971103 NDA NDA020646 Cephalon, Inc. TIAGABINE HYDROCHLORIDE 12 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63459-416_3363330b-7427-4191-942b-c55a433ab114 63459-416 HUMAN PRESCRIPTION DRUG GABITRIL tiagabine hydrochloride TABLET ORAL 19971103 NDA NDA020646 Cephalon, Inc. TIAGABINE HYDROCHLORIDE 16 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63459-502_5a01e886-99cf-49dd-bb2c-adf8d5cf9f9f 63459-502 HUMAN PRESCRIPTION DRUG ACTIQ fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 19981104 NDA NDA020747 Cephalon, Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63459-504_5a01e886-99cf-49dd-bb2c-adf8d5cf9f9f 63459-504 HUMAN PRESCRIPTION DRUG ACTIQ fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 19981104 NDA NDA020747 Cephalon, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63459-506_5a01e886-99cf-49dd-bb2c-adf8d5cf9f9f 63459-506 HUMAN PRESCRIPTION DRUG ACTIQ fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 19981104 NDA NDA020747 Cephalon, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63459-508_5a01e886-99cf-49dd-bb2c-adf8d5cf9f9f 63459-508 HUMAN PRESCRIPTION DRUG ACTIQ fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 19981104 NDA NDA020747 Cephalon, Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63459-512_5a01e886-99cf-49dd-bb2c-adf8d5cf9f9f 63459-512 HUMAN PRESCRIPTION DRUG ACTIQ fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 19981104 NDA NDA020747 Cephalon, Inc. FENTANYL CITRATE 1200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63459-516_5a01e886-99cf-49dd-bb2c-adf8d5cf9f9f 63459-516 HUMAN PRESCRIPTION DRUG ACTIQ fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 19981104 NDA NDA020747 Cephalon, Inc. FENTANYL CITRATE 1600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63459-541_d4911789-a0dc-4869-ae2a-83cf6ac71e40 63459-541 HUMAN PRESCRIPTION DRUG FENTORA fentanyl citrate TABLET BUCCAL; ORAL; TRANSMUCOSAL 20060925 NDA NDA021947 Cephalon, Inc. FENTANYL CITRATE 100 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63459-542_d4911789-a0dc-4869-ae2a-83cf6ac71e40 63459-542 HUMAN PRESCRIPTION DRUG FENTORA fentanyl citrate TABLET BUCCAL; ORAL; TRANSMUCOSAL 20060925 NDA NDA021947 Cephalon, Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63459-544_d4911789-a0dc-4869-ae2a-83cf6ac71e40 63459-544 HUMAN PRESCRIPTION DRUG FENTORA fentanyl citrate TABLET BUCCAL; ORAL; TRANSMUCOSAL 20060925 NDA NDA021947 Cephalon, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63459-546_d4911789-a0dc-4869-ae2a-83cf6ac71e40 63459-546 HUMAN PRESCRIPTION DRUG FENTORA fentanyl citrate TABLET BUCCAL; ORAL; TRANSMUCOSAL 20060925 NDA NDA021947 Cephalon, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63459-548_d4911789-a0dc-4869-ae2a-83cf6ac71e40 63459-548 HUMAN PRESCRIPTION DRUG FENTORA fentanyl citrate TABLET BUCCAL; ORAL; TRANSMUCOSAL 20060925 NDA NDA021947 Cephalon, Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63459-600_31e36202-7b2b-4531-9e1a-ce9fabf16e6c 63459-600 HUMAN PRESCRIPTION DRUG Trisenox arsenic trioxide INJECTION, SOLUTION INTRAVENOUS 20001015 NDA NDA021248 Cephalon, Inc. ARSENIC TRIOXIDE 1 mg/mL 63459-700_644b9ffe-6359-443f-98aa-6429c32f1bff 63459-700 HUMAN PRESCRIPTION DRUG AMRIX Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071001 NDA NDA021777 Cephalon, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63459-701_644b9ffe-6359-443f-98aa-6429c32f1bff 63459-701 HUMAN PRESCRIPTION DRUG AMRIX Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071001 NDA NDA021777 Cephalon, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 30 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63459-910_0ee3c492-d6bc-43ef-a11f-bf3ed140a209 63459-910 HUMAN PRESCRIPTION DRUG GRANIX tbo-filgrastim INJECTION, SOLUTION SUBCUTANEOUS 20131111 BLA BLA125294 Cephalon, Inc. FILGRASTIM 300 ug/.5mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] 63459-912_0ee3c492-d6bc-43ef-a11f-bf3ed140a209 63459-912 HUMAN PRESCRIPTION DRUG GRANIX tbo-filgrastim INJECTION, SOLUTION SUBCUTANEOUS 20131111 BLA BLA125294 Cephalon, Inc. FILGRASTIM 480 ug/.8mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] 63481-025_6d53ed12-d734-446a-980d-85eeaabde31f 63481-025 HUMAN PRESCRIPTION DRUG FROVA frovatriptan succinate TABLET, FILM COATED ORAL 20011108 NDA NDA021006 Endo Pharmaceuticals Inc. FROVATRIPTAN SUCCINATE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 63481-121_bb59db07-0f51-11df-8a39-0800200c9a66 63481-121 HUMAN PRESCRIPTION DRUG PERCODAN oxycodone hydrochloride and aspirin TABLET ORAL 19500412 NDA NDA007337 Endo Pharmaceuticals Inc ASPIRIN; OXYCODONE HYDROCHLORIDE 325; 4.8355 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 63481-183_665058c7-b85f-4b7f-8e20-1300a1c0d4fb 63481-183 HUMAN PRESCRIPTION DRUG FORTESTA testosterone GEL, METERED TOPICAL 20101229 NDA NDA021463 Endo Pharmaceuticals Inc. TESTOSTERONE 10 mg/.5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 63481-434_de0ede42-810c-4ba6-b049-11675fb583dd 63481-434 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20111209 NDA NDA201655 Endo Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-435_de0ede42-810c-4ba6-b049-11675fb583dd 63481-435 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochoride TABLET, EXTENDED RELEASE ORAL 20111209 NDA NDA201655 Endo Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 7.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-436_de0ede42-810c-4ba6-b049-11675fb583dd 63481-436 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20111209 NDA NDA201655 Endo Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-437_de0ede42-810c-4ba6-b049-11675fb583dd 63481-437 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20111209 NDA NDA201655 Endo Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-438_de0ede42-810c-4ba6-b049-11675fb583dd 63481-438 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20111209 NDA NDA201655 Endo Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-439_de0ede42-810c-4ba6-b049-11675fb583dd 63481-439 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20111209 NDA NDA201655 Endo Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-440_de0ede42-810c-4ba6-b049-11675fb583dd 63481-440 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20111209 NDA NDA201655 Endo Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-522_5ee31a7d-3ef4-4979-aaec-4c14bd34ee61 63481-522 HUMAN PRESCRIPTION DRUG OPANA ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20080301 NDA NDA021610 Endo Pharmaceuticals OXYMORPHONE HYDROCHLORIDE 7.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-553_5ee31a7d-3ef4-4979-aaec-4c14bd34ee61 63481-553 HUMAN PRESCRIPTION DRUG OPANA ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20080301 NDA NDA021610 Endo Pharmaceuticals OXYMORPHONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-571_5ee31a7d-3ef4-4979-aaec-4c14bd34ee61 63481-571 HUMAN PRESCRIPTION DRUG OPANA ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20080301 NDA NDA021610 Endo Pharmaceuticals OXYMORPHONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-612_9575c15a-dda1-416e-89cc-b31bc5b205db 63481-612 HUMAN PRESCRIPTION DRUG OPANA Oxymorphone Hydrochloride TABLET ORAL 20060626 NDA NDA021611 Endo Pharmaceuticals OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-613_9575c15a-dda1-416e-89cc-b31bc5b205db 63481-613 HUMAN PRESCRIPTION DRUG OPANA Oxymorphone Hydrochloride TABLET ORAL 20060626 NDA NDA021611 Endo Pharmaceuticals OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-617_5ee31a7d-3ef4-4979-aaec-4c14bd34ee61 63481-617 HUMAN PRESCRIPTION DRUG OPANA ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20060630 NDA NDA021610 Endo Pharmaceuticals OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-623_b8169f3b-0b34-4d00-9d75-8cf91aae83fe 63481-623 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride and acetaminophen TABLET ORAL 19990630 ANDA ANDA040330 Endo Pharmaceuticals ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-624_6bdc5c0e-92c6-4b30-ae83-180b921bc98f 63481-624 HUMAN PRESCRIPTION DRUG OPANA Oxymorphone Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19590601 NDA NDA011707 Endo Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-627_b8169f3b-0b34-4d00-9d75-8cf91aae83fe 63481-627 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride and acetaminophen TABLET ORAL 19990630 ANDA ANDA040330 Endo Pharmaceuticals ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 2.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-628_b8169f3b-0b34-4d00-9d75-8cf91aae83fe 63481-628 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride and acetaminophen TABLET ORAL 20011130 ANDA ANDA040434 Endo Pharmaceuticals ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-629_b8169f3b-0b34-4d00-9d75-8cf91aae83fe 63481-629 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride and acetaminophen TABLET ORAL 20011130 ANDA ANDA040434 Endo Pharmaceuticals ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-674_5ee31a7d-3ef4-4979-aaec-4c14bd34ee61 63481-674 HUMAN PRESCRIPTION DRUG OPANA ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20060630 NDA NDA021610 Endo Pharmaceuticals OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-684_bdc8c5ce-cbf6-49e7-900a-d09d281c94c8 63481-684 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20071017 NDA NDA022122 Endo Pharmaceuticals, Inc. DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63481-687_d169a8a3-beb1-4292-9395-a8bdd3443be9 63481-687 HUMAN PRESCRIPTION DRUG LIDODERM lidocaine PATCH CUTANEOUS 19990320 NDA NDA020612 Endo Pharmaceuticals Inc. LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63481-693_5ee31a7d-3ef4-4979-aaec-4c14bd34ee61 63481-693 HUMAN PRESCRIPTION DRUG OPANA ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20060630 NDA NDA021610 Endo Pharmaceuticals OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-812_0824dd1a-3f62-434c-821b-e5f440ff94a4 63481-812 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA201655 Endo Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-813_0824dd1a-3f62-434c-821b-e5f440ff94a4 63481-813 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA201655 Endo Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 7.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-814_0824dd1a-3f62-434c-821b-e5f440ff94a4 63481-814 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA201655 Endo Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-815_0824dd1a-3f62-434c-821b-e5f440ff94a4 63481-815 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA201655 Endo Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-816_0824dd1a-3f62-434c-821b-e5f440ff94a4 63481-816 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA201655 Endo Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-817_0824dd1a-3f62-434c-821b-e5f440ff94a4 63481-817 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA201655 Endo Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-818_0824dd1a-3f62-434c-821b-e5f440ff94a4 63481-818 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA201655 Endo Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63481-907_5ee31a7d-3ef4-4979-aaec-4c14bd34ee61 63481-907 HUMAN PRESCRIPTION DRUG OPANA ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20060630 NDA NDA021610 Endo Pharmaceuticals OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63505-003_a8270d5c-a4c1-4953-abfa-cf28531d263d 63505-003 HUMAN OTC DRUG Riche Creme Wrinkle Smoothing Day OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE LOTION TOPICAL 20120619 OTC MONOGRAPH FINAL part352 Yves Rocher North America Inc OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 60; 20; 70; 36 mg/mL; mg/mL; mg/mL; mg/mL 63505-004_8b2eda3b-5d7b-4857-9f85-66391734fed4 63505-004 HUMAN OTC DRUG Pure System Stop Blemish SALICYLIC ACID LOTION TOPICAL 20120619 OTC MONOGRAPH FINAL part333D Yves Rocher North America Inc SALICYLIC ACID .5 mL/100mL 63505-005_0c0ba41c-959a-4903-8a2b-58b9c824ed39 63505-005 HUMAN OTC DRUG Wrinkles and Radiance Dazzling -Day- SPF 20 ENSULIZOLE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20121010 OTC MONOGRAPH NOT FINAL part352 Yves Rocher North America Inc ENSULIZOLE; OCTINOXATE; OCTISALATE; ZINC OXIDE 40; 75; 50; 49 mg/mL; mg/mL; mg/mL; mg/mL 63505-006_a16032d7-9a3e-4bb5-8235-ae46e0ef7d1c 63505-006 HUMAN OTC DRUG YVES ROCHER hydra vegetal HYDRATING DAY SPF 25 SUNSCREEN ENSULIZOLE, OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20130605 OTC MONOGRAPH NOT FINAL part352 Yves Rocher North America Inc ENSULIZOLE; OCTINOXATE; OCTISALATE; ZINC OXIDE 40; 75; 50; 49 mg/mL; mg/mL; mg/mL; mg/mL 63505-156_33748420-ee6d-4962-988d-d31d50d4b2d7 63505-156 HUMAN OTC DRUG Protectyl soleil moisturizing sunscreen lotion high protection spf 30 Titanium Dioxide, Octinoxate and Octocrylene LOTION TOPICAL 20070501 OTC MONOGRAPH FINAL part352 Yves Rocher North America Inc OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 7; 8.4 mL/100mL; mL/100mL; mL/100mL 63505-157_b61bbe7d-07c4-4fcb-a6e7-2a8dd1c95f31 63505-157 HUMAN OTC DRUG FRAICHEUR VERVEINE ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20080701 OTC MONOGRAPH FINAL part350 YVES ROCHER NORTH AMERICA INC ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL 63505-158_a95425f3-08d0-4ea4-9ec9-ab0cdb6316ca 63505-158 HUMAN OTC DRUG FRAICHEUR CEDRE BLEU ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20081001 OTC MONOGRAPH FINAL part350 YVES ROCHER NORTH AMERICA INC ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL 63505-159_68494988-f0af-49cf-a39f-27ce07fe5247 63505-159 HUMAN OTC DRUG FRAICHEUR THE VERT ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20081001 OTC MONOGRAPH FINAL part350 YVES ROCHER NORTH AMERICA INC ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL 63505-160_8a68e3e4-baed-4a0f-bb51-20a104c01108 63505-160 HUMAN OTC DRUG FRAICHEUR BAMBOU ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20081001 OTC MONOGRAPH FINAL part350 YVES ROCHER NORTH AMERICA INC ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL 63505-161_3deaba9b-886a-400b-aa6b-6e35a4092731 63505-161 HUMAN OTC DRUG FRAICHEUR CHEVREFEUILLE ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20090201 OTC MONOGRAPH FINAL part350 YVES ROCHER NORTH AMERICA INC ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL 63505-163_c1301bb1-b78b-4e01-8062-3022a5bc28a2 63505-163 HUMAN OTC DRUG ANTISEPTIC HAND GEL ALCOHOL GEL TOPICAL 20091211 OTC MONOGRAPH NOT FINAL part333E YVES ROCHER NORTH AMERICA INC ALCOHOL 62 mL/100mL 63509-002_b349a64f-70d7-4163-b618-9474fcd3408c 63509-002 HUMAN OTC DRUG Skin Activator Lip Refiner SPF 15 Octinoxate, Octisalate and Avobenzone CREAM TOPICAL 20111021 OTC MONOGRAPH NOT FINAL part352 Cosmint Spa. AVOBENZONE; OCTINOXATE; OCTISALATE .0142; .0661; .0472 g/mL; g/mL; g/mL 63517-005_c7ef544d-ab37-413b-913f-ffec00033027 63517-005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 Cardinal Health SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 63517-016_85d81f07-f825-4419-81a2-d918b1740a3e 63517-016 HUMAN OTC DRUG Cardinal Health Fluoride Anticavity Fluoride Anticavity Toothpaste PASTE, DENTIFRICE ORAL 20130909 OTC MONOGRAPH FINAL part355 Cardinal Health SODIUM FLUORIDE 2.43 mg/g 63517-101_70ff3144-b9f9-4f5b-941f-1b55e11b600b 63517-101 HUMAN OTC DRUG CardinalHealth bathing wipe with dimethicone DIMETHICONE LIQUID TOPICAL 20131003 OTC MONOGRAPH FINAL part347 Cardinal Health DIMETHICONE 32 mg/100g 63517-102_3385f6a2-f362-40e4-ad9c-d6784411e639 63517-102 HUMAN OTC DRUG CardinalHealth personal cleansing cloth with dimethicone DIMETHICONE LIQUID TOPICAL 20131004 OTC MONOGRAPH FINAL part347 Cardinal Health DIMETHICONE 3.2 g/100g 63517-111_d4db68a0-b2e9-4f50-ae69-ff645ec493bb 63517-111 HUMAN OTC DRUG CardinalHealth alcohol prep pads MEDIUM ISOPROPYL ALCOHOL SWAB TOPICAL 20130414 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL 70 g/100g 63517-112_3627ba9c-7597-4dac-b14a-1e4217042b58 63517-112 HUMAN OTC DRUG CardinalHealth alcohol prep pads LARGE ISOPROPYL ALCOHOL SWAB TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL 70 g/100g 63517-160_9d9e981b-afa7-4372-a7da-4d133f291fcd 63517-160 HUMAN OTC DRUG Lemon Glycerin Glycerin SWAB ORAL 20130801 OTC MONOGRAPH NOT FINAL part356 Cardinal Health GLYCERIN 7.5 g/100g 63517-200_9edd89bf-7a58-4286-8de8-71bf7758253f 63517-200 HUMAN OTC DRUG CardinalHealth antibacterial bathing wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131003 OTC MONOGRAPH NOT FINAL part333E Cardinal Health BENZALKONIUM CHLORIDE .12 g/100g 63517-323_53e33344-16a3-45a4-b630-1deef0f7bf57 63517-323 HUMAN OTC DRUG CardinalHealth antiseptic BZK towelettes BENZALKONIUM CHLORIDE SWAB TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part333A Cardinal Health BENZALKONIUM CHLORIDE .133 g/100g 63517-418_35e16a75-aba5-473e-a5ce-eb197d3b0103 63517-418 HUMAN OTC DRUG Cardinal Health Antimicrobial Soap with Triclosan TRICLOSAN LIQUID TOPICAL 20110314 OTC MONOGRAPH NOT FINAL part333E Cardinal Health TRICLOSAN .003 mL/mL 63517-506_48159c5a-924f-4692-a29b-b7a487fa7eb7 63517-506 HUMAN OTC DRUG Cardinal Health Hand Sanitizer with Aloe ALCOHOL GEL TOPICAL 20110302 OTC MONOGRAPH NOT FINAL part333E Cardinal Health ALCOHOL .62 mL/mL 63517-523_b17fd616-85b2-4a66-8063-0da25bc5e3ee 63517-523 HUMAN OTC DRUG Cardinal Health Sanitizer ALCOHOL AEROSOL, FOAM TOPICAL 20110224 OTC MONOGRAPH NOT FINAL part333E Cardinal Health ALCOHOL .625 mg/mg 63517-803_d37da2ca-d5be-4afd-a437-1fc937b98224 63517-803 HUMAN OTC DRUG Roll On Anti-Perspirant (Alcohol Free) ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20130904 OTC MONOGRAPH FINAL part350 Cardinal Health ALUMINUM CHLOROHYDRATE .1 mg/mL 63533-221_1a16303b-d136-44f4-a724-2332d36d50ee 63533-221 HUMAN OTC DRUG Han-I-Size ALCOHOL GEL TOPICAL 20051201 OTC MONOGRAPH NOT FINAL part333E Momar Incorporated ALCOHOL .7 mL/mL 63533-576_989f632e-73e0-4211-b68b-7d63944d9c90 63533-576 HUMAN OTC DRUG Handtastic Foamy Mango TRICLOSAN SOAP TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333 Momar Incorporated TRICLOSAN .003 mL/mL 63533-585_8260614a-0d0d-4f14-bbf2-7a5da5d77feb 63533-585 HUMAN OTC DRUG Han-I-Foam ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333 Momar Incorporated ALCOHOL .7 mL/mL 63533-773_211aaff1-5087-479e-a52c-47438579b9b5 63533-773 HUMAN OTC DRUG Redeem ALCOHOL AEROSOL, FOAM TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part333 Momar Inc. ALCOHOL 620 mg/g 63533-855_6b6a6943-c0fe-4ead-9200-7d320ef3e86d 63533-855 HUMAN OTC DRUG Han-I-Foam ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333E Momar Incorporated ALCOHOL .62 mL/mL 63539-012_93b77ffd-fbfd-401b-999d-382efc343b37 63539-012 HUMAN PRESCRIPTION DRUG XELJANZ TOFACITINIB CITRATE TABLET, FILM COATED ORAL 20121108 NDA NDA203214 U.S. Pharmaceuticals TOFACITINIB CITRATE 5 mg/1 Janus Kinase Inhibitor [EPC],Janus Kinase Inhibitors [MoA] 63539-013_97ad1752-d9b5-460f-b49c-c7551e70f07e 63539-013 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 U.S. Pharmaceuticals PREGABALIN 50 mg/1 CV 63539-014_97ad1752-d9b5-460f-b49c-c7551e70f07e 63539-014 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 U.S. Pharmaceuticals PREGABALIN 75 mg/1 CV 63539-021_5a22d10c-03a3-4e84-8829-0d87fc901232 63539-021 HUMAN PRESCRIPTION DRUG Estring estradiol RING VAGINAL 19960426 NDA NDA020472 U.S. Pharmaceuticals ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 63539-039_3247c4cb-1d8d-474f-8049-03de64ff3044 63539-039 HUMAN PRESCRIPTION DRUG Nicotrol (Professional Sample) nicotine INHALANT RESPIRATORY (INHALATION) 19970502 NDA NDA020714 US Pharmaceuticals NICOTINE 4 mg/1 Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient] 63539-044_c6eac86d-4db4-4581-baae-1548780829a2 63539-044 HUMAN PRESCRIPTION DRUG INLYTA axitinib TABLET, FILM COATED ORAL 20120127 NDA NDA202324 U.S. Pharmaceuticals AXITINIB 5 mg/1 Kinase Inhibitor [EPC],Receptor Tyrosine Kinase Inhibitors [MoA] 63539-112_efdd202d-1033-4fb9-bd7f-f35d9b885676 63539-112 HUMAN PRESCRIPTION DRUG Duavee conjugated estrogens/bazedoxifene TABLET, FILM COATED ORAL 20131115 NDA NDA022247 U.S. Pharmaceuticals BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED 20; .45 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 63539-121_70405a5d-5f4a-49dc-bb08-509a4f18bfc9 63539-121 HUMAN PRESCRIPTION DRUG Caverject Impulse Alprostadil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 20140504 NDA NDA021212 U.S. Pharmaceuticals ALPROSTADIL 10 ug/.5mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 63539-122_4317e8a5-e0c7-472d-93be-89f20a6c5fe3 63539-122 HUMAN PRESCRIPTION DRUG Duavee conjugated estrogens/bazedoxifene TABLET, FILM COATED ORAL 20131115 NDA NDA022247 U.S. Pharmaceuticals BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED 20; .45 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 63539-183_47f19c39-9fd2-4471-9d91-08da92d4fb68 63539-183 HUMAN PRESCRIPTION DRUG Toviaz fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081031 NDA NDA022030 U.S. Pharmaceuticals FESOTERODINE FUMARATE 8 mg/1 63539-221_70405a5d-5f4a-49dc-bb08-509a4f18bfc9 63539-221 HUMAN PRESCRIPTION DRUG Caverject Impulse Alprostadil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 20140504 NDA NDA021212 U.S. Pharmaceuticals ALPROSTADIL 20 ug/.5mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] 63539-234_f9fb5d39-ca2b-4dd4-8df8-df08693d92fe 63539-234 HUMAN PRESCRIPTION DRUG Relpax eletriptan hydrobromide TABLET, FILM COATED ORAL 20021226 NDA NDA021016 U.S. Pharmaceuticals ELETRIPTAN HYDROBROMIDE 40 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 63539-242_47f19c39-9fd2-4471-9d91-08da92d4fb68 63539-242 HUMAN PRESCRIPTION DRUG Toviaz fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081031 NDA NDA022030 U.S. Pharmaceuticals FESOTERODINE FUMARATE 4 mg/1 63539-421_c2714d79-69e5-47d2-921c-6565c578f9af 63539-421 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 U.S. Pharmaceuticals SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 63539-422_c2714d79-69e5-47d2-921c-6565c578f9af 63539-422 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 U.S. Pharmaceuticals SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 63539-473_4a2d0c20-80c8-4f52-97d9-07e5995b1ffd 63539-473 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate KIT 20060510 NDA NDA021928 U.S. Pharmaceuticals 63539-5195_7471257b-abf3-47a9-8f62-5de1fe41922a 63539-5195 HUMAN PRESCRIPTION DRUG Nicotrol (Professional Sample) nicotine INHALANT RESPIRATORY (INHALATION) 19970502 NDA NDA020714 U.S. Pharmaceuticals NICOTINE 4 mg/1 Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient] 63545-142_52c0574a-22f4-4c67-b0b9-6c5f6467c48f 63545-142 HUMAN OTC DRUG SINECCH ARNICA MONTANA CAPSULE ORAL 19980630 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals ARNICA MONTANA 1 [hp_M]/1 63545-516_1eda24a1-7641-4f07-b61c-f04488448673 63545-516 HUMAN OTC DRUG SINECCHi ARNICA MONTANA CAPSULE ORAL 20070630 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals ARNICA MONTANA 1 [hp_M]/1 63545-517_82aa8419-5bc4-4897-8614-f08717b58c37 63545-517 HUMAN OTC DRUG TraumaCare ARNICA MONTANA CAPSULE ORAL 20070630 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals ARNICA MONTANA 1 [hp_M]/1 63545-637_595eeecf-1aca-4256-84ff-89a7c70e1731 63545-637 HUMAN OTC DRUG HAHNEMANN HEADACHE YTTRIUM IODIDE PELLET ORAL 20090330 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals YTTRIUM IODIDE 200 [hp_C]/1 63545-639_54d7e16d-7ef3-4439-99d6-994e4b112c67 63545-639 HUMAN OTC DRUG HAHNEMANN FEVER PERIDOT PELLET ORAL 20101231 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals OLIVINE 200 [hp_C]/1 63545-640_fd103d2d-947e-4e7e-9e2d-7b45afa46b7d 63545-640 HUMAN OTC DRUG HAHNEMANN HEADACHE KEROSENE PELLET ORAL 20101231 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals KEROSENE 200 [hp_C]/1 63545-644_7200b290-af60-46f5-b01b-688cb07f3f44 63545-644 HUMAN OTC DRUG HAHNEMANN COLDS YTTRIUM FLUORIDE PELLET ORAL 20101231 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals YTTRIUM FLUORIDE 200 [hp_C]/1 63545-645_481d63ea-9cd0-4fd6-9074-4603818ce4d8 63545-645 HUMAN OTC DRUG HAHNEMANN COLDS YTTRIUM BROMIDE PELLET ORAL 20101231 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals YTTRIUM BROMIDE 200 [hp_C]/1 63545-646_cb2e4476-08a3-41fc-8893-e02d25ea6b0b 63545-646 HUMAN OTC DRUG HAHNEMANN SNEEZING GLYCERIN PELLET ORAL 20110331 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals GLYCERIN 200 [hp_C]/1 63548-0007_5b7902b6-5781-47e0-b574-ad8716cc0e66 63548-0007 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20110118 OTC MONOGRAPH FINAL part341 Avema Pharma Solutions GUAIFENESIN 400 mg/1 63548-0046_168ccdca-6ba8-4edc-9c0e-504ae9aa065a 63548-0046 HUMAN OTC DRUG Aspirin Enteric Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 20110811 OTC MONOGRAPH FINAL part343 Avema Pharma Solutions ASPIRIN 81 mg/1 63548-0056_627333c2-4233-4a95-bd93-53d1257ef07e 63548-0056 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative Docusate sodium and Sennosides TABLET ORAL 20110518 OTC MONOGRAPH NOT FINAL part334 Avema Pharma Solutions DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 63548-0064_6896cbdd-7377-4305-9bef-8c876ac1bfbd 63548-0064 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCL TABLET ORAL 20110116 OTC MONOGRAPH FINAL part338 Avema Pharma Solutions DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63548-0065_89c90659-b059-4b99-bdce-b31d3e78a48c 63548-0065 HUMAN OTC DRUG Pain Relief PM Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20120514 OTC MONOGRAPH NOT FINAL part343 Avema Pharma Solutions ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 63548-0068_55b12994-1ec8-4dba-b37f-d9b385e39773 63548-0068 HUMAN OTC DRUG Gentle Relief Senna Laxative Sennosides TABLET ORAL 20120430 OTC MONOGRAPH FINAL part334 Avema Pharma Solutions SENNOSIDES A AND B 8.6 mg/1 63548-0069_00978d30-54d2-4131-9bd2-be522c3cf3f4 63548-0069 HUMAN OTC DRUG Senna-S DOCUSATE SODIUM, SENNOSIDES TABLET, COATED ORAL 20120430 OTC MONOGRAPH NOT FINAL part334 Avema Pharma Solutions DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 63548-0070_64d48a9c-8432-4538-8560-ccd4a10e5345 63548-0070 HUMAN OTC DRUG Antihistimine Allergy DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20120430 OTC MONOGRAPH FINAL part341 Avema Pharma Solutions DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63548-1278_dccb0b89-87d9-4a27-8b3b-39e8c84e3a3e 63548-1278 HUMAN OTC DRUG Senna Laxative Sennosides TABLET, COATED ORAL 20100102 OTC MONOGRAPH FINAL part341 Avema Pharma Solutions SENNOSIDES 8.6 mg/1 63548-2341_691c5587-3994-45e2-a669-608ba7a98bfb 63548-2341 HUMAN OTC DRUG Pain Relief PM Acetaminophen and Diphenhydramine Hydrochloride TABLET, COATED ORAL 20100102 UNAPPROVED DRUG OTHER Avema Pharma Solutions ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 63548-3482_f0ef7742-a09e-4d1b-9658-e9c0ba8ee003 63548-3482 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride TABLET, COATED ORAL 20100102 OTC MONOGRAPH FINAL part341 Avema Pharma Solutions DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63548-3602_0ca53eeb-d615-4666-9599-67525d2ddef5 63548-3602 HUMAN OTC DRUG Asprin Aspirin TABLET, DELAYED RELEASE ORAL 20100102 OTC MONOGRAPH FINAL part343 Avema Pharma Solutions ASPIRIN 81 mg/1 63548-3733_8ec52f26-6b58-4b66-8653-614cf055ba80 63548-3733 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, COATED ORAL 20100102 UNAPPROVED DRUG OTHER Avema Pharma Solutions GUAIFENESIN 400 mg/1 63548-4000_a3c1cd07-a6ee-44b0-9854-622d8ba2d8f8 63548-4000 HUMAN OTC DRUG Stool Softener Docusate Sodium and Sennosides TABLET, COATED ORAL 20100102 UNAPPROVED DRUG OTHER Avema Pharma Solutions DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 63548-4001_27ed056c-ec07-4269-9883-1f856c338aca 63548-4001 HUMAN OTC DRUG Senna-S Docusate Sodium and Sennosides TABLET, COATED ORAL 20100102 UNAPPROVED DRUG OTHER Avema Pharma Solutions DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 63548-6352_9ea81f82-8fee-4569-8cfc-a102a9747de0 63548-6352 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan Hydrobromide and Guaifenesin TABLET, COATED ORAL 20100102 OTC MONOGRAPH FINAL part341 Avema Pharma Solutions DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 63548-6373_058eef84-fdbc-4f27-a619-72e89d535766 63548-6373 HUMAN OTC DRUG Sleep Easy Diphenhydramine Hydrochloride TABLET, COATED ORAL 20100102 OTC MONOGRAPH FINAL part338 Avema Pharma Solutions DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63549-919_e6f0f0dd-940a-490f-a404-56dd561264e6 63549-919 HUMAN PRESCRIPTION DRUG ISOXSUPRINE HYDROCHLORIDE isoxsuprine hydrochloride TABLET ORAL 20110823 UNAPPROVED DRUG OTHER Vedco dba Valdar ISOXSUPRINE HYDROCHLORIDE 20 mg/1 63550-114_032bdb34-57da-4a6d-b88a-5358b3807c37 63550-114 HUMAN OTC DRUG LIP BALM OCTINOXATE OXYBENZONE ZINC OXIDE OINTMENT TOPICAL 20120307 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. OCTINOXATE; OXYBENZONE; ZINC OXIDE 75; 50; 40 mg/g; mg/g; mg/g 63550-120_8f3e15c7-aae1-4add-b028-d9b9081bb798 63550-120 HUMAN OTC DRUG DAY C AVOBENZONE OCTINOXATE OXYBENZONE CREAM TOPICAL 20120312 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE 20; 70; 50 mg/g; mg/g; mg/g 63550-122_e847604f-6169-4e63-9a46-a71458b44cb2 63550-122 HUMAN OTC DRUG DAY L AVOBENZONE OCTISALATE OCTINOXATE LOTION TOPICAL 20120307 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 25; 75; 40 mg/mL; mg/mL; mg/mL 63550-154_ac2c8d21-73dc-4bc5-9378-f9e1ca13fca3 63550-154 HUMAN OTC DRUG Anti-Blemish Salicylic Acid DISC TOPICAL 20100809 OTC MONOGRAPH FINAL part333 Kamins Dermatologics Inc. SALICYLIC ACID 20 mg/1 63550-158_08ec1173-8886-4703-9792-5e957d6c1608 63550-158 HUMAN OTC DRUG Tinted Moisturizer SPF 20 ZINC OXIDE TITANIUM DIOXIDE CREAM TOPICAL 20110831 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. TITANIUM DIOXIDE; ZINC OXIDE 44; 75 mg/mL; mg/mL 63550-191_6a4261c3-68ef-4108-9898-dbed33861919 63550-191 HUMAN OTC DRUG Matte Moisturizer SPF 15 OCTINOXATE OCTISALATE AVOBENZONE CREAM TOPICAL 20101018 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 25; 75; 40 mg/mL; mg/mL; mg/mL 63550-192_cdf7ecb2-4019-4046-97fa-762acfda4a5b 63550-192 HUMAN OTC DRUG Soothing Day SPF 15 AVOBENZONE OCTINOXATE OXYBENZONE CREAM TOPICAL 20101019 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE 20; 70; 50 mg/mL; mg/mL; mg/mL 63550-193_c97bc999-1ba0-454e-9a53-735e2d0337b3 63550-193 HUMAN OTC DRUG Blemish Benzoyl peroxide GEL TOPICAL 20101019 OTC MONOGRAPH NOT FINAL part333D Kamins Dermatologics Inc. BENZOYL PEROXIDE 50 mg/mL 63550-194_75dc31bc-4d3f-482d-abd3-d60cdddcf89d 63550-194 HUMAN OTC DRUG BLEMISH Benzoyl peroxide GEL TOPICAL 20101019 OTC MONOGRAPH NOT FINAL part333D Kamins Dermatologics Inc. BENZOYL PEROXIDE 100 mg/mL 63550-809_30b4cbbf-d534-4fca-9e49-05738ba8e688 63550-809 HUMAN OTC DRUG Sunbar SPF 48 Ensulizole Homosalate Octinoxate Octocrylene Zinc oxide CREAM TOPICAL 20100929 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. ENSULIZOLE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 30; 100; 75; 70; 80 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 63550-810_e20e5f13-95b4-4bfc-9b95-44533d0c533f 63550-810 HUMAN OTC DRUG SUNBAR SPF 15 AVOBENZONE HOMOSALATE OCTISALATE OXYBENZONE SPRAY TOPICAL 20100930 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 30; 100; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL 63550-811_df11c3bb-6819-4495-baed-c2c9d9baee86 63550-811 HUMAN OTC DRUG SUNBAR SPF 30 Avobenzone Octinoxate Oxybenzone Titanium dioxide LOTION TOPICAL 20101015 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 25; 75; 6; 20 mg/mL; mg/mL; mg/mL; mg/mL 63550-850_3f806047-1d73-45c8-870a-3c7cdfcd08b8 63550-850 HUMAN OTC DRUG SUN DEFENSE SPF 15 AVOBENZONE HOMOSALATE OCTISALATE OXYBENZONE SPRAY TOPICAL 20110902 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 30; 100; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL 63550-851_bb4d7be9-2550-424b-80a0-b968df95e619 63550-851 HUMAN OTC DRUG SUN DEFENSE SPF 30 Avobenzone Octinoxate Oxybenzone Titanium dioxide LOTION TOPICAL 20110902 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 25; 75; 6; 20 mg/mL; mg/mL; mg/mL; mg/mL 63550-852_54f7851c-d8e2-45a0-847d-e49cd78c6661 63550-852 HUMAN OTC DRUG Sun Defense UVscreen SPF 48 Ensulizole Homosalate Octinoxate Octocrylene Zinc oxide CREAM TOPICAL 20110902 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. ENSULIZOLE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 30; 100; 75; 70; 80 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 63551-007_fb4de2f6-cc67-4144-9a72-5005acbd9297 63551-007 HUMAN OTC DRUG Stat-Foam ALCOHOL LIQUID TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part333E Triad Group ALCOHOL .7 mL/mL 63551-220_3f1a3be7-28d3-40aa-bbbd-771d979e3507 63551-220 HUMAN OTC DRUG Health Stat TRICLOSAN SOAP TOPICAL 20001218 OTC MONOGRAPH NOT FINAL part333 Triad Group TRICLOSAN .003 mL/mL 63551-221_97d8bcb3-f8f5-4d45-abfe-9fd93b820b88 63551-221 HUMAN OTC DRUG Stat-Rinse ALCOHOL GEL TOPICAL 20001201 OTC MONOGRAPH NOT FINAL part333 Triad Group ALCOHOL .7 mL/mL 63551-576_af758b7e-ec81-4827-b043-4abd805b5b74 63551-576 HUMAN OTC DRUG Health-Stat Foam TRICLOSAN SOAP TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Triad Group TRICLOSAN .003 mL/mL 63560-001_35204a4e-2262-4206-b26b-e79556668b90 63560-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980501 UNAPPROVED MEDICAL GAS Memorial Home Services of Central Illinois, Inc OXYGEN 992 mL/L 63565-0001_af9b295a-d949-4a12-a2e5-4ebaa4f2b098 63565-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19930801 UNAPPROVED MEDICAL GAS Williams Medical Supply, Inc. OXYGEN 99 L/100L 63577-035_8d4416f6-19a3-42fe-9f78-1d4537bd4ec1 63577-035 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20050801 UNAPPROVED MEDICAL GAS Central Medical Equipment Co. OXYGEN 99 L/100L 63580-269_ed5b3bd0-cb5b-4caf-8c00-f528081e3a98 63580-269 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Coastal Med Tech, Inc. OXYGEN 99 L/100L 63621-353_c593bf39-c84f-4d5a-b260-c0c58747b18f 63621-353 HUMAN OTC DRUG SunDrops 67 Chloroxylenol LIQUID CUTANEOUS 20100707 UNAPPROVED DRUG OTHER Sunburst Chemicals, Inc. CHLOROXYLENOL .75 g/100mL 63621-354_d7f22bb7-71d7-43ec-b81d-99af044efa33 63621-354 HUMAN OTC DRUG SunDrops 77 Benzalkonium Chloride SOAP TOPICAL 20080505 OTC MONOGRAPH NOT FINAL part333E Sunburst Chemicals, Inc. BENZALKONIUM CHLORIDE 1 mg/mL 63621-355_bc0bc37c-da49-420d-888e-06965c73a2fe 63621-355 HUMAN OTC DRUG SunDrops 73 Alcohol SOAP TOPICAL 20091014 OTC MONOGRAPH NOT FINAL part333E Sunburst Chemicals, Inc. ALCOHOL 650 mL/L 63621-356_37a56d74-96bd-4ae6-8443-edd64209b6e9 63621-356 HUMAN OTC DRUG SunDrops 75 Alcohol GEL CUTANEOUS 20091014 UNAPPROVED OTHER Sunburst Chemicals, Inc. ALCOHOL .6 mL/mL 63621-400_41545171-227e-4cb5-9a6b-ab83cd4a86a7 63621-400 HUMAN OTC DRUG Prestige Chloroxylenol SOAP TOPICAL 20140502 OTC MONOGRAPH NOT FINAL part333E Sunburst Chemicals, Inc. CHLOROXYLENOL 10 mg/mL 63629-1233_31d4ddf3-875b-4f8e-af02-de23ac40ce82 63629-1233 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20090806 ANDA ANDA071118 bryant ranch prepack LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-1241_1d295d65-ebf9-440e-aa59-747418d09ce0 63629-1241 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET, FILM COATED ORAL 20100225 ANDA ANDA075504 Bryant Ranch Prepack QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-1242_71f771ac-b917-494d-8737-682ba06a4d40 63629-1242 HUMAN PRESCRIPTION DRUG Accupril quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA NDA019885 Bryant Ranch Prepack QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-1248_8c358cd9-f387-47d9-946f-c0551f5a6501 63629-1248 HUMAN PRESCRIPTION DRUG Amoxicillin/Clavulanate Potassium Amoxicillin/Clavulanate Potassium TABLET ORAL 20090612 ANDA ANDA065093 bryant ranch prepack AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 63629-1249_d9c14a7e-285b-4226-88ca-4199afbc1265 63629-1249 HUMAN PRESCRIPTION DRUG Allegra-D FEXOFENADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE ORAL 20090304 ANDA ANDA020786 bryant ranch prepack FEXOFENADINE; PSEUDOEPHEDRINE 60; 60 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 63629-1250_d5615199-5b0c-4fd9-a59a-3f4a5cb27d01 63629-1250 HUMAN PRESCRIPTION DRUG Flurbiprofen Flurbiprofen TABLET, FILM COATED ORAL 19950602 ANDA ANDA074431 Bryant Ranch Prepack FLURBIPROFEN 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1253_194e09a4-fcdb-4024-822a-b15066a0875d 63629-1253 HUMAN PRESCRIPTION DRUG RAMIPRIL RAMIPRIL CAPSULE ORAL 20090505 ANDA ANDA076549 Bryant Ranch Prepack RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-1254_7e46a06f-0003-4f46-8b66-8cd16c0e9688 63629-1254 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 Bryant Ranch Prepack RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-1255_72296538-97bc-44e1-9fa3-c47de5958ba6 63629-1255 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Bryant Ranch Prepack GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 63629-1256_e6fdb39d-6649-4245-944f-e840769e33e4 63629-1256 HUMAN PRESCRIPTION DRUG Ambien zolpidem tartrate TABLET, FILM COATED ORAL 19930401 NDA NDA019908 Bryant Ranch Prepack ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 63629-1260_1acdc98b-2ac1-00da-2bc6-d3ec78b5b015 63629-1260 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Bryant Ranch Prepack NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1260_a79c6fb7-46d1-465b-8e1f-31f3a1fc98b3 63629-1260 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20090730 ANDA ANDA078432 bryant ranch prepack NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1263_7829437b-a9ca-4ff7-869b-82bcbe774684 63629-1263 HUMAN PRESCRIPTION DRUG Arava leflunomide TABLET, FILM COATED ORAL 19980910 NDA NDA020905 Bryant Ranch Prepack LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] 63629-1266_536d5642-d218-41c3-b043-ca321df86ed4 63629-1266 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087128 Bryant Ranch Prepack MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 63629-1284_3a6e48f8-d847-4168-97a0-c007fdab52cc 63629-1284 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, EXTENDED RELEASE ORAL 20090530 ANDA ANDA065154 bryant ranch prepack CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 63629-1286_592041a1-4cac-006d-16bc-bc05066ab0c2 63629-1286 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20070701 ANDA ANDA078220 Bryant Ranch Rrepack BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 63629-1299_46187fb9-6c5c-480e-bbba-6d4514c93ae8 63629-1299 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 Bryant Ranch Prepack DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 63629-1305_55629d6a-5dbf-4f11-bfbf-557e5957c944 63629-1305 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor CAPSULE ORAL 20091106 ANDA ANDA064156 bryant ranch prepack CEFACLOR 250 mg/1 63629-1307_240afad2-4a41-40ef-a242-bc2a76848ffe 63629-1307 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20100108 ANDA ANDA070848 Bryant Ranch Prepack SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 63629-1308_10c236b1-5b05-47bd-b32b-27b1457829be 63629-1308 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 Bryant Ranch Prepack CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 63629-1309_244c0f3d-0765-4f3d-a215-3e01e73a219f 63629-1309 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20110527 ANDA ANDA075509 Bryant Ranch Prepack DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 63629-1318_89642fa4-c030-0bcd-eb35-c139285d0d8e 63629-1318 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20041112 ANDA ANDA077032 Bryant Ranch Prepack CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-1320_3bbb5eac-78de-4f89-b67a-b17c2b887cba 63629-1320 HUMAN PRESCRIPTION DRUG CEFACLOR CEFACLOR CAPSULE ORAL 20070501 ANDA ANDA065350 Bryant Ranch Prepack CEFACLOR 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63629-1326_c04c46bd-e2f1-463e-a9dc-d7da124bfdbd 63629-1326 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Bryant Ranch Prepack CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 63629-1328_e0f907c8-ebc0-44b4-951c-fd8964a8cfbe 63629-1328 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070974 Bryant Ranch Prepack CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 63629-1329_c4f306db-2e82-4c41-b6a1-b6008fc272f2 63629-1329 HUMAN PRESCRIPTION DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 Bryant Ranch Prepack LORATADINE 10 mg/1 63629-1330_49422e04-2bc1-46b6-8198-aa37a195d818 63629-1330 HUMAN PRESCRIPTION DRUG Loratadine and Pseudoephedrine loratadine and pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Bryant Ranch Prepack LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 63629-1335_133b795c-8b3a-41e3-b3dd-731f52803207 63629-1335 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960725 ANDA ANDA040120 Bryant Ranch Prepack PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 63629-1337_1b89c719-ac97-466f-b73c-c431364f6489 63629-1337 HUMAN PRESCRIPTION DRUG COZAAR losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Bryant Ranch Prepack LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-1338_b2e10e07-ab6c-4f3c-8cf7-c2d9d0adcbf3 63629-1338 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Bryant Ranch Prepack CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-1339_ebef89f8-4e9a-48d2-a3fe-0adfa02f680f 63629-1339 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100218 ANDA ANDA078218 Bryant Ranch Prepack CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63629-1340_cfb59cce-8546-4559-87b1-d28a70916e66 63629-1340 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Bryant Ranch Prepack CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-1341_baa9a202-e9cd-4995-8d8a-6a4abf66e0d4 63629-1341 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Bryant Ranch Prepack CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-1342_e19b9dde-c1f5-4bdc-8ee9-86bbc08a2e7e 63629-1342 HUMAN OTC DRUG Docusate Sodium and Senna Docusate Sodium and Senna TABLET, FILM COATED ORAL 20110922 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 63629-1343_eac4c726-7e7e-4bc1-a93f-9dbbd3e5c157 63629-1343 HUMAN OTC DRUG diphenhydramine hydrochloride diphenhydramine hydrochloride CAPSULE ORAL 20000501 OTC MONOGRAPH FINAL part341 Bryant Ranch Prepack DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63629-1344_977bf184-d263-4032-9de5-f3a483f19d9a 63629-1344 HUMAN PRESCRIPTION DRUG Propoxyphene Napsylate and Acetaminophen propoxyphene napsylate and acetaminophen TABLET, FILM COATED ORAL 20091104 ANDA ANDA070145 Bryant Ranch Prepack ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 650; 100 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 63629-1345_0ae487b9-0ab4-4ba1-b61b-1c82e43b0163 63629-1345 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20100908 ANDA ANDA075849 Bryant Ranch Prepack OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1346_f7d3daa3-c21a-48a2-89f4-481e74b66a5e 63629-1346 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110101 ANDA ANDA079234 Bryant Ranch Prepack TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63629-1349_1c7e8e35-8a03-4b3f-ae8e-112fab41b440 63629-1349 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 Bryant Ranch Prepack DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 63629-1354_09df946d-2930-9002-2ea6-80f0993d45dd 63629-1354 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 19971031 ANDA ANDA075079 Bryant Ranch Prepack OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 63629-1355_8c28447f-0998-4743-bf90-4d758eeaccf7 63629-1355 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20110308 ANDA ANDA075536 Bryant Ranch Prepack DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 63629-1359_4c948453-26a3-4391-852c-0e5a31a03205 63629-1359 HUMAN PRESCRIPTION DRUG Propoxyphene Hydrochloride Propoxyphene Hydrochloride CAPSULE ORAL 20091223 ANDA ANDA088615 Bryant Ranch Prepack PROPOXYPHENE HYDROCHLORIDE 65 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 63629-1360_c7a5837a-5137-4eb2-982b-f72b20db6241 63629-1360 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20070122 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack DOCUSATE SODIUM 100 mg/1 63629-1368_9075e9e9-8bc3-4085-b452-f92c1024159b 63629-1368 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 63629-1369_f078347f-665c-4e78-bf21-28b5f5e701b4 63629-1369 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET ORAL 20091023 ANDA ANDA085966 bryant ranch prepack AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 63629-1370_a799397d-141d-42fe-a889-806d20e4756c 63629-1370 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 63629-1374_79c5b637-b777-4087-9207-bf29189ad56a 63629-1374 HUMAN PRESCRIPTION DRUG Erythrocin Stearate Erythromycin Stearate TABLET, FILM COATED ORAL 19640624 ANDA ANDA060359 Bryant Ranch Prepack ERYTHROMYCIN STEARATE 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 63629-1376_7a113b45-4b5b-40f7-aed4-4b09959f3eda 63629-1376 HUMAN PRESCRIPTION DRUG Lodine etodolac CAPSULE, GELATIN COATED ORAL 20090630 ANDA ANDA075126 bryant ranch prepack ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1377_fb45a8b4-1c3c-4d59-b0f8-1a7bbc9428b9 63629-1377 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20100430 ANDA ANDA075009 Bryant Ranch Prepack ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1383_3ac96e00-d5e1-754e-7bf1-c51a5223b20b 63629-1383 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20100105 ANDA ANDA074118 Bryant Ranch Prepack PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1386_85693a34-74b5-447c-952e-ccda9cc9eb22 63629-1386 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070033 Bryant Ranch Prepack METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 63629-1388_85693a34-74b5-447c-952e-ccda9cc9eb22 63629-1388 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070027 Bryant Ranch Prepack METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 63629-1390_ea9fdf28-6b36-4d0c-95b3-05e3a2e188cd 63629-1390 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19981001 ANDA ANDA075034 Bryant Ranch Prepack GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 63629-1392_fabcb1e1-c02a-4a1a-8bc8-0bdadcb9f296 63629-1392 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20070507 ANDA ANDA076345 Bryant Ranch Prepack GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 63629-1393_b34ddafe-fae5-4dec-ae42-ccb64a2df21f 63629-1393 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Bryant Ranch Prepack GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 63629-1394_26790b12-fdc5-4f50-a631-d0f57307b2ed 63629-1394 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Bryant Ranch Prepack GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 63629-1395_22ae8ad8-d146-41cd-af63-ab4a882db728 63629-1395 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 63629-1396_1f0130b5-9bfc-4000-a4d6-cf91e4755af7 63629-1396 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 63629-1397_f13fc544-8aed-4c2d-a51a-b8d2653c5249 63629-1397 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 63629-1398_35724abb-ff25-4f44-946e-fd32c2807096 63629-1398 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Bryant Ranch Prepack GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 63629-1400_49d90c85-02f7-40e9-acf7-61674f6f0f24 63629-1400 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100820 ANDA ANDA040807 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-1413_00f46a7e-2332-44a2-9cd6-5fa92f337f7a 63629-1413 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100820 ANDA ANDA040807 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-1414_ec1c2692-67b0-43ba-9753-0d0492ad41d4 63629-1414 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075317 Bryant Ranch Prepack TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 63629-1415_24483c7e-571b-4493-a47a-108931957897 63629-1415 HUMAN PRESCRIPTION DRUG Isoniazid isoniazid SOLUTION ORAL 19831111 ANDA ANDA088235 Bryant Ranch Prepack ISONIAZID 50 mg/5mL Antimycobacterial [EPC] 63629-1418_1dbce66c-a5d7-4075-9b67-e4cf633e30ad 63629-1418 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20100730 ANDA ANDA018851 Bryant Ranch Prepack INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1422_8b8b9ef0-abac-4cb6-bfab-f47368aad901 63629-1422 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19810714 ANDA ANDA087425 Bryant Ranch Prepack ISONIAZID 300 mg/1 Antimycobacterial [EPC] 63629-1423_0fa353d9-d36b-43bd-9393-419d5b96c413 63629-1423 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-1424_e3d887ce-46cb-42ea-857c-c1f3170a260d 63629-1424 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 63629-1434_c0715e53-b9ce-400d-9032-dbb83e8da787 63629-1434 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Bryant Ranch Prepack FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63629-1435_eb506f38-45d0-4cbf-9850-aa3cae3df037 63629-1435 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19870827 ANDA ANDA070082 Bryant Ranch Prepack FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63629-1446_86fcd130-b644-41c0-b2f9-218fbe5b94fb 63629-1446 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-1447_02af24d4-741e-413f-aed7-c3acc0fcdd68 63629-1447 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-1452_f4bef700-91c2-438d-9fe2-28fb812d211d 63629-1452 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA073192 Bryant Ranch Prepack LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 63629-1454_a143c3a7-559f-7e23-dab1-7cf77a13c9d7 63629-1454 HUMAN PRESCRIPTION DRUG Amlobenz Amlobenz CAPSULE ORAL 20100419 ANDA ANDA077183 Bryant Ranch Prepack AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63629-1459_8321224c-f3bf-4150-9e5b-6f0f2a9382df 63629-1459 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin (monohydrate/macrocrystals) CAPSULE ORAL 19701125 ANDA ANDA080043 Bryant Ranch Prepack NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 63629-1462_5b3543ab-3030-43c2-836b-e6e620bda91b 63629-1462 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090315 ANDA ANDA078459 Bryant Ranch Prepack METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-1463_24d79ae5-a04c-434c-99b9-dea548da9f26 63629-1463 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090315 ANDA ANDA078459 Bryant Ranch Prepack METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-1464_fe7ed67c-2a28-47e7-9941-0b5a724dfdf1 63629-1464 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20090615 ANDA ANDA075551 Bryant Ranch Prepack LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-1467_5f0df3aa-7a95-46f8-a550-4131d6226e94 63629-1467 HUMAN PRESCRIPTION DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 20040101 ANDA ANDA075010 Bryant Ranch Prepack IBUPROFEN 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1468_95624fa6-2509-460b-b7b4-7879ef222a71 63629-1468 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Bryant Ranch Prepack IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1469_1002f565-4865-4110-a26d-f6b9bda6d5ff 63629-1469 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Bryant Ranch Prepack IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1470_90b9a65a-708d-4c29-9111-980096de480f 63629-1470 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Bryant Ranch Prepack IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1472_009a7004-d6f0-4dfc-2763-6c5370c6dc68 63629-1472 HUMAN PRESCRIPTION DRUG Methotrexate Sodium Methotrexate Sodium TABLET ORAL 19940801 ANDA ANDA040054 Bryant Ranch Prepack METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 63629-1476_2727182e-096e-4dcf-8a5e-b933230e7928 63629-1476 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040114 ANDA ANDA076494 Bryant Ranch Prepack NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1477_11f6f749-c45f-4975-b5b2-f1b84e677f42 63629-1477 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Bryant Ranch Prepack NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1485_08aac1dc-f0de-4e49-bae8-b7f9d35fb8c6 63629-1485 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615 ANDA ANDA075273 Bryant Ranch Prepack KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 63629-1491_7285f0a3-210a-4798-8236-2f5020c2fd15 63629-1491 HUMAN PRESCRIPTION DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 19941001 OTC MONOGRAPH FINAL part341 Bryant Ranch Prepack PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 63629-1494_03423596-4d58-4fa2-aaf6-f04d61e6b7c2 63629-1494 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19900930 ANDA ANDA088628 Bryant Ranch Prepack ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 63629-1495_773fce44-d245-4e4c-8bae-f0372573f093 63629-1495 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20031206 ANDA ANDA074463 Bryant Ranch Prepack CIMETIDINE 800 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63629-1497_6ea55751-89c9-43af-9df7-dc639e924a44 63629-1497 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20101001 ANDA ANDA074151 Bryant Ranch Prepack CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63629-1501_b4e872f7-3537-465c-a2b6-c6e43495197a 63629-1501 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20100323 ANDA ANDA060704 Bryant Ranch Prepack TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 63629-1502_0dafe9a9-c7d8-4f3c-933a-cf7d228e6ae4 63629-1502 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20101219 ANDA ANDA061837 Bryant Ranch Prepack TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 63629-1507_bb98d1e9-73aa-4e61-bbe8-ac5ab57a01c2 63629-1507 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 19970605 ANDA ANDA074821 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-1510_5b2ba81e-f919-7b9c-7b5a-8beca56fdbd9 63629-1510 HUMAN PRESCRIPTION DRUG imipramine hydrochloride imipramine hydrochloride TABLET, FILM COATED ORAL 19900605 ANDA ANDA081050 Bryant Ranch Prepack IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 63629-1513_9dd76fa3-300b-443a-8403-5cbc5e2dee6d 63629-1513 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072192 Bryant Ranch Prepack TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 63629-1514_91e2d4fa-2eb8-4813-b6c2-2890d6d0129b 63629-1514 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20060510 ANDA ANDA076635 Bryant Ranch Prepack FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 63629-1516_36f5f2c5-780b-4c09-9269-935f522528bd 63629-1516 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 19890101 OTC MONOGRAPH FINAL part343 Bryant Ranch Prepack ACETAMINOPHEN 500 mg/1 63629-1518_f11b14ce-1cc6-41eb-a037-cc5adca20f0f 63629-1518 HUMAN PRESCRIPTION DRUG Regular Strength QPAP Acetaminophen TABLET ORAL 19960201 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ACETAMINOPHEN 325 mg/1 63629-1522_15c67106-d56b-4206-2a55-b90c79a87c94 63629-1522 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Bryant Ranch Prepack ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63629-1523_9e93b792-ca23-470d-9afa-2e43396a4dd0 63629-1523 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071321 Bryant Ranch Prepack DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-1524_201bbba3-68dd-4aa7-b760-9daf819c0eae 63629-1524 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Bryant Ranch Prepack DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-1525_68b1496c-81b7-46e0-91b8-d20deb3a454a 63629-1525 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Bryant Ranch Prepack ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63629-1526_268779c5-29fe-a928-dfb6-e8f2dbd95666 63629-1526 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Bryant Ranch Prepack ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63629-1528_bfc340bf-ba64-48c8-ad77-ae8365375273 63629-1528 HUMAN PRESCRIPTION DRUG Mebendazole Mebendazole TABLET, CHEWABLE ORAL 20100428 ANDA ANDA073580 Bryant Ranch Prepack MEBENDAZOLE 100 mg/1 Antihelminthic [EPC] 63629-1529_ee30e53b-9436-490a-bcce-cffe5369704b 63629-1529 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040084 Bryant Ranch Prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63629-1531_9261937a-de31-73eb-6aed-e000f2acb49d 63629-1531 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19841107 ANDA ANDA062396 Bryant Ranch Prepack DOXYCYCLINE HYCLATE 100 mg/1 63629-1532_2c088c9c-d949-40d6-bd35-386aed7aaa94 63629-1532 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA089160 Bryant Ranch Prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63629-1533_38425efb-bd6a-4299-a35d-7ba28886424a 63629-1533 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 Bryant Ranch Prepack HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 63629-1534_af958ecd-647b-4249-9ac2-3410577af49b 63629-1534 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 20150228 ANDA ANDA075185 Bryant Ranch Prepack DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1535_3894ab46-7ea9-48ed-b504-69cc68b0c408 63629-1535 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Bryant Ranch Prepack DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1536_e9037927-384f-41fa-b1a3-997cafb833e2 63629-1536 HUMAN PRESCRIPTION DRUG VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63629-1541_76f07536-e338-4984-ba2a-148ce9c5a92d 63629-1541 HUMAN PRESCRIPTION DRUG ALPRAZOLAM EXTENDED-RELEASE ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070328 ANDA ANDA077996 Bryant Ranch Prepack ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-1558_ed9c2f96-8b5a-4b08-94ce-cc6c643e6193 63629-1558 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE ORAL 20090811 ANDA ANDA072781 Bryant Ranch Prepack NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63629-1559_ca82193d-1559-4d7e-98b7-a40549a2138e 63629-1559 HUMAN PRESCRIPTION DRUG Nifedical XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20010209 ANDA ANDA075289 Bryant Ranch Prepack NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63629-1560_cc68aa62-5057-4fb7-8c1f-a986a310d1e1 63629-1560 HUMAN PRESCRIPTION DRUG Nifedical XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20001211 ANDA ANDA075289 Bryant Ranch Prepack NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63629-1561_43172b4d-31c3-4c1f-a8ef-cba1adfc75ba 63629-1561 HUMAN PRESCRIPTION DRUG Nifediac CC Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020916 ANDA ANDA076070 Bryant Ranch Prepack NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63629-1564_8e3e6281-655b-4fec-a9d2-39087b785865 63629-1564 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Bryant Ranch Prepack ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63629-1565_4532546c-34cf-4648-9b26-bd6c278ce4af 63629-1565 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070524 ANDA ANDA076719 Bryant Ranch Prepack AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63629-1566_1dbf7a3b-0e6b-43e7-a59d-d11c80b4a153 63629-1566 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070524 ANDA ANDA076719 Bryant Ranch Prepack AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63629-1572_06e94b40-95e3-4740-96d3-6e3bbdb28167 63629-1572 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Bryant Ranch Prepack GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-1579_f0050283-737d-4b1a-9c0d-962c7d892772 63629-1579 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Bryant Ranch Prepack PREDNISONE 10 mg/1 63629-1584_c30a2b35-4689-4f67-8066-139689d4afb0 63629-1584 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20020104 ANDA ANDA040377 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 63629-1585_156f8813-cd44-4985-9f1a-002be0cfc3b5 63629-1585 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20071030 ANDA ANDA078341 Bryant Ranch Prepack FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 63629-1586_1ff481d5-133f-441f-9634-65b48eb2d23a 63629-1586 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20081223 ANDA ANDA089859 Bryant Ranch Prepack CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63629-1587_e93b9510-4811-4c59-a29c-f7621825450e 63629-1587 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 Bryant Ranch Prepack PREDNISONE 20 mg/1 63629-1588_b1636b17-bad3-4c9f-8448-2d879ca87433 63629-1588 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextromethorphan Hydrobromide Promethazine Hydrochloride and Dextromethorphan Hydrobromide SOLUTION ORAL 19960731 ANDA ANDA040027 Bryant Ranch Prepack DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] 63629-1591_7e4fe236-fbeb-4201-83e3-9be1caf822f2 63629-1591 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Bryant Ranch Prepack PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 63629-1594_6837d4c4-818d-407b-8fd1-b0b8d6f2055a 63629-1594 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride SOLUTION OPHTHALMIC 19900930 UNAPPROVED DRUG OTHER Bryant Ranch Prepack PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 63629-1595_649bb8af-6515-4652-a3c5-79433984cd87 63629-1595 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Bryant Ranch Prepack PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 63629-1596_2ffa1c2a-517c-48e6-8a0d-352dc66598a6 63629-1596 HUMAN PRESCRIPTION DRUG PLENDIL Felodipine TABLET, EXTENDED RELEASE ORAL 19910916 NDA NDA019834 Bryant Ranch Prepack FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63629-1597_290fe174-0128-46e2-ae85-15b23717807f 63629-1597 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 ANDA ANDA075896 Bryant Ranch Prepack FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63629-1598_266e9384-4b12-453a-ba0a-65bebf9ea245 63629-1598 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 19000101 NDA NDA020839 Bryant Ranch Prepack CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 63629-1603_64eb4f58-700c-41f5-b35e-a1fb35df423d 63629-1603 HUMAN PRESCRIPTION DRUG PROPECIA finasteride TABLET, FILM COATED ORAL 19971219 NDA NDA020788 Bryant Ranch Prepack FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 63629-1604_281377de-81c3-4fec-96e9-7b426190c3f9 63629-1604 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20090601 ANDA ANDA085588 bryant ranch prepack PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 63629-1605_fdfbda10-dcdf-44fe-8059-d039b6a5a488 63629-1605 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Bryant Ranch Prepack PREDNISONE 5 mg/1 63629-1606_f30fb7e7-9848-4c13-bb52-a33b02edea8e 63629-1606 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA076939 Bryant Ranch Prepack PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-1607_ca56e5cd-711e-4ae9-a826-2dcd3ff15ebf 63629-1607 HUMAN PRESCRIPTION DRUG Prometh with Codeine promethazine hydrochloride and codeine phosphate SYRUP ORAL 20030103 ANDA ANDA088763 Bryant Ranch Prepack CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 63629-1609_c5de6c5c-4b7f-4d96-89ad-41e68e0ca4ed 63629-1609 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Bryant Ranch Prepack FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-1610_59cbeacd-45ba-4402-9a1f-421e763fd007 63629-1610 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Bryant Ranch Prepack FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-1611_6f7be72d-4259-4e9c-9633-a73c7b238b15 63629-1611 HUMAN PRESCRIPTION DRUG PROVIGIL modafinil TABLET ORAL 19981224 NDA NDA020717 Bryant Ranch Prepack MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 63629-1613_c022fc30-f1f0-47a3-9256-7dc078b547ea 63629-1613 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole CAPSULE, DELAYED RELEASE ORAL 19950510 NDA NDA020406 Bryant Ranch Prepack LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 63629-1616_47e40a00-0e9b-4264-a671-2e1a7c7da1f6 63629-1616 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl Phenazopyridine HCl TABLET ORAL 20100910 UNAPPROVED DRUG OTHER Bryant Ranch Prepack PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 63629-1618_86f1322b-8a86-4073-bfb0-68585c30e3af 63629-1618 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20090313 ANDA ANDA078807 Bryant Ranch Prepack METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 63629-1619_d467f676-0865-424c-bd30-2c4352cacee9 63629-1619 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 Bryant Ranch Prepack TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-1620_2f779ef2-6b80-4edc-9573-d51a40c3433d 63629-1620 HUMAN PRESCRIPTION DRUG Nabumetone nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Bryant Ranch Prepack NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1621_2ddd2fa1-2093-427f-91e0-5c785eedd170 63629-1621 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 Bryant Ranch Prepack TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-1622_73dbf01c-b3ba-425d-88a6-f44abab49f0f 63629-1622 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20100301 ANDA ANDA090200 Bryant Ranch Prepack METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63629-1623_786135cd-7aa4-4792-94a5-d18c34d4e3c8 63629-1623 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Bryant Ranch Prepack METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63629-1639_7ecaa07a-cd7b-4173-b028-10fd871545e3 63629-1639 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, FILM COATED ORAL 19980220 NDA NDA020829 Bryant Ranch Prepack MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 63629-1647_24d3c496-8176-4b6b-99c3-f193a2dc08a3 63629-1647 HUMAN PRESCRIPTION DRUG SPORANOX ITRACONAZOLE CAPSULE ORAL 19920911 NDA NDA020083 Bryant Ranch Prepack ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 63629-1671_4729538f-9410-0f3d-764f-96d62617a243 63629-1671 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Bryant Ranch Prepack RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63629-1672_0acbbfe7-2497-3d7c-cdc6-a39c1a4db7d5 63629-1672 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET, FILM COATED ORAL 19970829 ANDA ANDA074467 Bryant Ranch Prepack RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63629-1673_6c379f2d-7ef1-0030-ed0d-d3227c602964 63629-1673 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Bryant Ranch Prepack TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 63629-1674_d6473910-16aa-4ab9-8c9c-3383a3c6b74e 63629-1674 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20000925 ANDA ANDA075579 Bryant Ranch Prepack BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-1675_b067187e-8489-4d6d-86a9-ae0364e40c0d 63629-1675 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018832 Bryant Ranch Prepack ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 63629-1676_ec58af2d-1415-47a2-b03f-4af2001e6134 63629-1676 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 19970423 ANDA ANDA074578 Bryant Ranch Prepack ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63629-1677_4aacbba8-69e7-4431-ae5a-dce9a508ed3e 63629-1677 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20110527 ANDA ANDA074556 Bryant Ranch Prepack ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63629-1678_396dea0f-f28f-4bf7-bf7a-aae52466032c 63629-1678 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19990305 ANDA ANDA075382 Bryant Ranch Prepack ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63629-1679_4aa1195b-7baa-41f9-9552-ed8a07ab9bb3 63629-1679 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA075776 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-1706_fef176ea-8ed6-489c-a87a-ad418fdcdff5 63629-1706 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Bryant Ranch Prepack CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-1724_23c40668-450f-4453-a5b8-ecc0d99c860f 63629-1724 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Bryant Ranch Prepack CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 63629-1728_1aa9399b-c9ef-454d-b35c-1a02a81c93ae 63629-1728 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63629-1734_5e8a172f-839a-4e30-9598-f79e1a564990 63629-1734 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20000526 ANDA ANDA040357 Bryant Ranch Prepack ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 63629-1740_978d79db-cd94-41e9-92ca-2f40ddcc83d2 63629-1740 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Bryant Ranch Prepack ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-1742_8f283967-2c57-42d3-9d0e-0c26df0213b7 63629-1742 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19730919 ANDA ANDA083426 Bryant Ranch Prepack PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 63629-1747_d478fe31-e339-48e7-82da-f29199389d8a 63629-1747 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020301 ANDA ANDA075022 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 15 mg/1 63629-1748_dfcf0f68-7e8c-4dd2-8b9e-3072dea8c6fb 63629-1748 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin (monohydrate/macrocrystals) CAPSULE ORAL 19701125 ANDA ANDA080043 Bryant Ranch Prepack NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 63629-1751_9ce1e6c1-3f02-4c44-bc4b-09572d46ae8c 63629-1751 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Bryant Ranch Prepack HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 63629-1761_7f3a7dd2-f9d3-4fdc-a7eb-59444ad6a54d 63629-1761 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20051117 ANDA ANDA077321 Bryant Ranch Prepack LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-1762_72cfe2f0-e2ff-4eb9-9a6c-7cb97adac811 63629-1762 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, DELAYED RELEASE ORAL 20120508 OTC MONOGRAPH FINAL part343 Bryant Ranch Prepack ASPIRIN 325 mg/1 63629-1765_805ee595-67db-4c15-bf80-8ddd24b19af7 63629-1765 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Bryant Ranch Prepack SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 63629-1774_897a9638-3b16-46dd-bc8c-0a9cfcff31f6 63629-1774 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030827 ANDA ANDA040511 Bryant Ranch Prepack ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 63629-1780_092b3dfe-c86a-4eda-8907-e98122204c79 63629-1780 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20100730 ANDA ANDA018851 Bryant Ranch Prepack INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1781_18947719-55b5-4582-97f1-7b1dab2dca6c 63629-1781 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018877 Bryant Ranch Prepack ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 63629-1783_67df1aa2-7966-4ab8-9a0b-160376e057bd 63629-1783 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20031124 ANDA ANDA074151 Bryant Ranch Prepack CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63629-1784_94311351-8b98-43d0-bd4b-568ad2e5c68e 63629-1784 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075551 Bryant Ranch Prepack LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-1785_ad9473e3-81b6-431b-b8d7-5be9c8ad729b 63629-1785 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Bryant Ranch Prepack ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-1789_508788b6-d098-4a8d-b23d-6c8e17ea17af 63629-1789 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20060714 OTC MONOGRAPH FINAL part336 Bryant Ranch Prepack MECLIZINE HYDROCHLORIDE 12.5 mg/1 63629-1792_35f6002e-f9ac-4ea0-b0b6-6b1b93d65935 63629-1792 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Bryant Ranch Prepack SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 63629-1793_5585711c-4a25-4b91-ab53-3fd2ff096054 63629-1793 HUMAN PRESCRIPTION DRUG Good Sense All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 19970114 ANDA ANDA079096 Bryant Ranch Prepack NAPROXEN SODIUM 220 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1809_c5b571e0-b746-4ca5-9c37-ad63fde6bd5c 63629-1809 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076631 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-1823_0f60e854-01e4-473e-be74-38fe50e32a08 63629-1823 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 63629-1830_85b0a0ce-ea24-45f1-911e-6966bd0719f9 63629-1830 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET ORAL 19860723 ANDA ANDA089424 Bryant Ranch Prepack SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 63629-1836_6dbce436-8d2b-4f12-aa2c-79da1621aefc 63629-1836 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 20110118 ANDA ANDA073517 Bryant Ranch Prepack KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-1837_31ae6903-64f2-4ac4-9a5c-adb5c96afd19 63629-1837 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20110501 NDA NDA021342 Bryant Ranch Prepack LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63629-1838_e0dee626-ef6b-2e8b-755c-5d931f6d8ab7 63629-1838 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63629-1839_9848013c-393d-12b5-3e76-f316a3ff01e3 63629-1839 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63629-1840_ee6d626a-cd50-d93e-fd02-448390e8320c 63629-1840 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Bryant Ranch Prepack PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-1841_199a9879-2b1c-47ec-b2a0-76b809c1dc91 63629-1841 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine Maleate TABLET ORAL 19980301 ANDA ANDA040268 Bryant Ranch Prepack PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 63629-1842_f0529ac2-00fd-44f2-b6f5-a0f8a0b854f4 63629-1842 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070810 ANDA ANDA078494 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-1855_9cf83127-e20d-4ca0-92a2-a0fd884d210e 63629-1855 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride SYRUP ORAL 19950309 ANDA ANDA087294 Bryant Ranch Prepack HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 63629-1862_0b64b7b0-6439-41b2-9f7c-bdfaaeaae9f4 63629-1862 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 20030227 ANDA ANDA040401 Bryant Ranch Prepack PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63629-1866_0a941ebe-9a39-4b05-86e4-48a3753e6ec6 63629-1866 HUMAN PRESCRIPTION DRUG Metaproterenol Sulfate Metaproterenol Sulfate SYRUP ORAL 19920722 ANDA ANDA073632 Bryant Ranch Prepack METAPROTERENOL SULFATE 10 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 63629-1868_fb3a6213-a11f-4f64-8552-aaa11adbfcc9 63629-1868 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride and phenylephrine hydrochloride Promethazine hydrochloride and phenylephrine hydrochloride SYRUP ORAL 20111219 ANDA ANDA088761 Bryant Ranch Prepack PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 5; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 63629-2541_22d47bec-1025-49e8-9918-6451668ebc8d 63629-2541 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090911 ANDA ANDA074532 Bryant Ranch Prepack CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-2548_a476f5cf-43a3-4939-9014-7401fc1bd0d7 63629-2548 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Bryant Ranch Prepack WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 63629-2552_958a3e12-0f99-4989-9f85-4aa0f3ebb086 63629-2552 HUMAN PRESCRIPTION DRUG Phenytoin Sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20110707 ANDA ANDA040298 Bryant Ranch Prepack PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-2570_66866b5b-a655-47b3-a220-840cbcd5d692 63629-2570 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-2573_9bbe9b70-5747-4fbb-b6c4-b52533ab946c 63629-2573 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086066 Bryant Ranch Prepack ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 63629-2579_a44fcd44-72c5-455c-86de-ba8915d41513 63629-2579 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 Bryant Ranch Prepack DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 63629-2585_182e3da6-11f6-454f-a7a3-8030d2654aa2 63629-2585 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA071851 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-2593_f1455573-24d3-4688-938b-d24cfed95d77 63629-2593 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Bryant Ranch Prepack GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-2598_3810a365-4f0f-4b39-9219-89ff274534f6 63629-2598 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 19950415 ANDA ANDA062512 Bryant Ranch Prepack NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 63629-2607_eda3ab19-7cfe-42b9-8b1a-a7c832be4619 63629-2607 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20110506 ANDA ANDA075876 Bryant Ranch Prepack OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 63629-2612_a1025f65-5b55-433d-b9c1-37bb0b1211cc 63629-2612 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 Bryant Ranch Prepack MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 63629-2613_c3e20f7f-0e4a-44d4-8b49-2b653d8e7ffc 63629-2613 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 Bryant Ranch Prepack MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 63629-2614_d2653032-ba47-447b-a98b-1752e4cb9990 63629-2614 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961203 ANDA ANDA040159 Bryant Ranch Prepack MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 63629-2625_a0444d5e-aaee-4b25-90cf-d2f83abc69d7 63629-2625 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET, SUGAR COATED ORAL 20110922 OTC MONOGRAPH FINAL part341 Bryant Ranch Prepack PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 63629-2626_751fb29f-16b5-4fd8-9fee-d1fa5cb2db92 63629-2626 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Bryant Ranch Prepack ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-2638_4d202483-ea1b-c56f-0c5c-ac878746faba 63629-2638 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 19891205 ANDA ANDA072637 Bryant Ranch Prepack ALBUTEROL SULFATE 2 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 63629-2640_e250557d-a9bd-469a-9abb-0fee2b2848fc 63629-2640 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Bryant Ranch Prepack SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 63629-2642_fbf3092b-2061-4bf5-899a-c412814fd8b5 63629-2642 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 63629-2647_71df9236-7cb0-43fa-9236-c050c2f8d6aa 63629-2647 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19920430 ANDA ANDA073281 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-2653_f237a097-c02e-4e1a-b1af-a1d38b4c2764 63629-2653 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 Bryant Ranch Prepack FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 63629-2655_a54cf72e-831d-4d97-b317-491c8364680f 63629-2655 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 19930401 ANDA ANDA081297 Bryant Ranch Prepack BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 63629-2672_322fce74-1057-434e-983f-ec4d363ca251 63629-2672 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20090629 ANDA ANDA076211 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63629-2679_4cd74e00-b0ad-4b46-bea0-8bb57de00ff8 63629-2679 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63629-2680_1db9dc9e-95db-496a-a2fc-a179a461f18c 63629-2680 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076631 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-2681_a2e36bef-667f-423e-9ef6-90989e087400 63629-2681 HUMAN PRESCRIPTION DRUG Amantadine HCl Amantadine hydrochloride CAPSULE ORAL 20081101 ANDA ANDA078720 Bryant Ranch Prepack AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 63629-2682_b32e24da-ef4b-4e98-90f2-dc9ec7b3e25a 63629-2682 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Bryant Ranch Prepack NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-2683_4c720ab3-1918-4ded-b223-de6509efbd49 63629-2683 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Bryant Ranch Prepack FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63629-2688_30c43307-f4fc-4bcf-bd2c-f3ede1289b9a 63629-2688 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Bryant Ranch Prepack LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-2696_1e843611-2132-4cf2-b9f1-af65f222f397 63629-2696 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone SOLUTION ORAL 20071101 ANDA ANDA088248 Bryant Ranch Prepack DEXAMETHASONE .5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63629-2697_ae42f917-1065-cabd-15a1-4fd12036460d 63629-2697 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63629-2712_d4808056-38ac-a639-bcbc-60c540267cb9 63629-2712 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63629-2718_054200f7-a059-c63f-edb0-c43a4ac202bb 63629-2718 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63629-2724_d6e1c309-eb3a-4354-8a3b-bb4f603844ca 63629-2724 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-2733_dd3f3642-50cf-4f60-9031-64f5d0826f30 63629-2733 HUMAN PRESCRIPTION DRUG AcipHex rabeprazole sodium TABLET, COATED ORAL 19990819 NDA NDA020973 Bryant Ranch Prepack RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 63629-2734_bc988476-f780-41dd-8b41-b7b0c9abfe87 63629-2734 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Bryant Ranch Prepack TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 63629-2735_053be5d6-ae87-4fb4-911d-e692e8b2b74a 63629-2735 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076631 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-2736_421c0535-c26d-444f-84ce-0b02ccc8b854 63629-2736 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 19891205 ANDA ANDA072637 Bryant Ranch Prepack ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 63629-2745_6ef8e4ea-1f0b-488c-8c69-13b77a33702d 63629-2745 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET ORAL 20000530 OTC MONOGRAPH FINAL part341 Bryant Ranch Prepack CHLORPHENIRAMINE MALEATE 4 mg/1 63629-2753_10f96cb0-3522-4f94-9651-defc2240b81e 63629-2753 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070924 Bryant Ranch Prepack CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 63629-2756_c78cd7fb-7f9b-4b67-ad43-6b779b7e53a5 63629-2756 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Bryant Ranch Prepack CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 63629-2759_5f0d0ca8-c746-47e0-a4be-26a77361a8d9 63629-2759 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Bryant Ranch Prepack MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 63629-2766_87a5b882-3fa1-4ecc-9704-d3ce3b514b27 63629-2766 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Bryant Ranch Prepack ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 63629-2767_cdc6143b-d484-4a68-b85b-4b896a77944c 63629-2767 HUMAN PRESCRIPTION DRUG Prometrium Progesterone CAPSULE ORAL 20100730 NDA NDA019781 Bryant Ranch Prepack PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 63629-2768_d4e8786e-254d-49ec-91e2-d76038d4779b 63629-2768 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 Bryant Ranch Prepack METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63629-2769_05ff440b-b378-4557-b616-d3c600f13001 63629-2769 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20050915 ANDA ANDA077314 Bryant Ranch Prepack NIZATIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63629-2770_26a5f310-536e-4b9c-b60d-3471df109c88 63629-2770 HUMAN PRESCRIPTION DRUG Prometrium Progesterone CAPSULE ORAL 20100730 NDA NDA019781 Bryant Ranch Prepack PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] 63629-2782_0a32aecc-a14e-4d72-8937-e5868ab1dcc7 63629-2782 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Bryant Ranch Prepack FAMOTIDINE 40 mg/1 63629-2792_f0052e64-09e9-40ae-b5bd-48e9c9ee4e93 63629-2792 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20100913 ANDA ANDA089808 Bryant Ranch Prepack THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 63629-2793_3c5c4fd3-ed2d-4c73-8aa7-4d32ece8b9b4 63629-2793 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20070614 ANDA ANDA076345 Bryant Ranch Prepack GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 63629-2796_66489b40-5d11-42e6-9fc3-0ed1e098d33a 63629-2796 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Bryant Ranch Prepack MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 63629-2806_670abf0d-5cad-8ac3-306c-c5d24616f076 63629-2806 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63629-2807_b2390a9a-f3d6-4b65-9949-706ae0161bff 63629-2807 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20110101 ANDA ANDA077533 Bryant Ranch Prepack TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 63629-2816_03f22fd8-fd9c-4f08-94b9-4d41f443f0d7 63629-2816 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091202 ANDA ANDA040625 Bryant Ranch Prepack FOLIC ACID 1 mg/1 63629-2817_814902fe-e5b8-44d1-b212-c0d2ac22ce70 63629-2817 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 19910731 ANDA ANDA063083 Bryant Ranch Prepack CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 63629-2825_563c4e29-44b9-4fa0-9420-e29be719c45b 63629-2825 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20080428 OTC MONOGRAPH FINAL part343 Bryant Ranch Prepack ASPIRIN 81 mg/1 63629-2833_f203e099-5eb1-16d9-d53a-db6d51354586 63629-2833 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073554 Bryant Ranch Prepack NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 63629-2844_cdb17887-1677-4c46-9afe-c1dc9b5964dd 63629-2844 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20010326 NDA NDA019962 Bryant Ranch Prepack METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-2867_5e333cad-fba0-4d55-b2f5-7c80b949f46f 63629-2867 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071525 Bryant Ranch Prepack TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 63629-2873_b4ad24ad-6386-4117-af10-fc9d15bbe28d 63629-2873 HUMAN PRESCRIPTION DRUG BUDEPRION SR BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20040323 ANDA ANDA075913 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 63629-2882_a67b9739-0a86-4428-aa1f-4cf64777f3f8 63629-2882 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070176 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-2883_edc6887d-b621-4fc7-8029-f4c58a09fff4 63629-2883 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 63629-2884_3f9d359f-43f9-4f42-98d3-df3b7a6cc702 63629-2884 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Bryant Ranch Prepack VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-2887_4e1dfc50-def7-4864-8acb-f0cf551c01e2 63629-2887 HUMAN PRESCRIPTION DRUG Clarithromycin clarithromycin TABLET, COATED ORAL 20040525 ANDA ANDA065178 Bryant Ranch Prepack CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 63629-2896_ebe41672-bb43-4c42-ad01-7671c7fd572a 63629-2896 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Bryant Ranch Prepack CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-2904_20b86266-9320-4345-a819-a8b8ad96ffcb 63629-2904 HUMAN OTC DRUG FAMOTIDINE FAMOTIDINE TABLET ORAL 20100806 ANDA ANDA090837 Bryant Ranch Prepack FAMOTIDINE 20 mg/1 63629-2907_add7bb8e-5929-4ab9-854d-18b52784b7e2 63629-2907 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Bryant Ranch Prepack GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 63629-2908_09189b20-3bfa-41dc-b715-90191d508307 63629-2908 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Bryant Ranch Prepack LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-2909_0b6838fb-0b21-4fdf-8294-a390d46330f3 63629-2909 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Bryant Ranch Prepack ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 63629-2910_94d54ea8-b355-4bbf-abbe-e16bbb23d9b4 63629-2910 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 19990610 ANDA ANDA075191 Bryant Ranch Prepack PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 63629-2912_b3441dee-4369-461d-9868-798de86960fa 63629-2912 HUMAN PRESCRIPTION DRUG COZAAR losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Bryant Ranch Prepack LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-2923_1c7bdc39-e1c3-47e1-8045-2dee0ea0f349 63629-2923 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63629-2924_49674fbf-0e30-d082-5ad8-13414c84a7dc 63629-2924 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20030318 ANDA ANDA063083 Bryant Ranch Prepack CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 63629-2926_59bd27a0-7eee-4b8e-a5d2-1046caf3bef3 63629-2926 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 19961227 NDA AUTHORIZED GENERIC NDA020504 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-2935_07b4dfb3-0b68-4f9e-bf35-ff39dc6e39a1 63629-2935 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 Bryant Ranch Prepack LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-2937_8370ab54-b466-419b-b7e0-fae800eeee7b 63629-2937 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Bryant Ranch Prepack POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 63629-2942_c89986aa-e7a2-46ed-9df5-784a1bd7e09d 63629-2942 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080402 ANDA ANDA074342 Bryant Ranch Prepack ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-2945_7a7e65ab-d1df-477e-b163-b7e211eb4c0b 63629-2945 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19900930 ANDA ANDA088627 Bryant Ranch Prepack ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 63629-2948_9bae1cd3-8c26-4a16-8a18-42ebab93895a 63629-2948 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071307 Bryant Ranch Prepack DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-2949_95bd2134-1e7b-442a-8d4f-35741bfa2522 63629-2949 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 63629-2950_de73523c-c3dc-4800-9fd2-c09b550ca216 63629-2950 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE ORAL 19970428 ANDA ANDA040886 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 63629-2951_21f2cd35-3257-4a6a-acfe-a88e6bc78577 63629-2951 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine TABLET ORAL 19790605 ANDA ANDA086162 Bryant Ranch Prepack ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 63629-2952_8eea3ef7-8b62-4283-bf50-bca77781059c 63629-2952 HUMAN PRESCRIPTION DRUG butalbital, aspirin, caffeine and codeine phosphate butalbital, aspirin, caffeine and codeine phosphate CAPSULE ORAL 20100330 ANDA ANDA075231 bryant ranch prepack ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 63629-2953_36500e56-63d3-4633-834a-59144fa0af5d 63629-2953 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072926 Bryant Ranch Prepack LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-2954_6cae0f10-4123-4142-9a2c-3e225bed9411 63629-2954 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072928 Bryant Ranch Prepack LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-2955_0177343b-a353-403f-a36f-5c4656ab98ae 63629-2955 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Bryant Ranch Prepack ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-2956_1f66adbd-5b36-4c4b-be88-c0d6f545e1d9 63629-2956 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 19940601 ANDA ANDA074224 Bryant Ranch Prepack TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-2959_1cf8a80f-61ff-4aa7-a564-14df1409a4aa 63629-2959 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP ORAL 20111219 ANDA ANDA088764 Bryant Ranch Prepack CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 10; 5; 6.25 mg/5mL; mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 63629-2962_de094629-9a7f-4632-bc73-80f152381304 63629-2962 HUMAN PRESCRIPTION DRUG Hydromet Hydrocodone Bitartate and Homatropine Methylbromide SYRUP ORAL 20081201 ANDA ANDA088017 Bryant Ranch Prepack HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5; 5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63629-2967_966c5301-f99b-4cac-965d-17c92a48ec3e 63629-2967 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 20080101 NDA NDA011722 Bryant Ranch Prepack DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 63629-2974_ae6a51d1-7a25-4e9c-9eed-98dd4f08983b 63629-2974 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20100420 ANDA ANDA074754 Bryant Ranch Prepack KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-2979_ab8e2247-7a40-45d7-9ef9-e6fe64433f40 63629-2979 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 19980220 NDA NDA020830 Bryant Ranch Prepack MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 63629-2981_b9aed06d-6fd4-37bb-215d-dae20a72fdc8 63629-2981 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Bryant Ranch Prepack ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-2982_c73bbec9-f677-4cd7-aa65-f8aa75d95148 63629-2982 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20090123 ANDA ANDA087056 Bryant Ranch Prepack CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 63629-3021_d0efddfc-344e-4fa4-b750-62d86d83a46b 63629-3021 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Bryant Ranch Prepack CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-3031_30a4984a-ef37-4ae0-9499-6833bac3d8ee 63629-3031 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20091117 ANDA ANDA040419 Bryant Ranch Prepack ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 63629-3034_b0d67e64-c14c-44d0-abb6-312fd2eb0f90 63629-3034 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 19861208 ANDA ANDA077107 Bryant Ranch Prepack FLURAZEPAM HYDROCHLORIDE 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-3043_452ed884-fdec-4717-a320-0abf94e0922a 63629-3043 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Bryant Ranch Prepack GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 63629-3047_ad4461bd-7fbf-4624-8e77-1538df512e97 63629-3047 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 10 mg/1 63629-3049_2be4867b-cb90-4c80-a482-d0c4f2221a5d 63629-3049 HUMAN OTC DRUG Enteric Coated Stimulant Laxative Bisacodyl TABLET, DELAYED RELEASE ORAL 20110922 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack BISACODYL 5 mg/1 63629-3051_0d5edc89-3291-4473-9e27-5cbcaafc81c7 63629-3051 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate CAPSULE, EXTENDED RELEASE ORAL 19770906 NDA NDA018074 Bryant Ranch Prepack PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 63629-3052_ea1e54d2-3992-4dac-b1b4-5aca6834b3f1 63629-3052 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19920801 ANDA ANDA073568 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63629-3056_55a3fa9a-6bec-4717-b422-3f5f81392659 63629-3056 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Bryant Ranch Prepack GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-3063_5e1553ef-f27b-4d15-be11-2d3437305855 63629-3063 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Bryant Ranch Prepack GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-3066_49185987-903d-48e9-93d7-a6f11c5aeeae 63629-3066 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN TABLET ORAL 20090605 ANDA ANDA090177 Bryant Ranch Prepack ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3092_dbc8010d-bd40-46a9-8e99-63af951e2a77 63629-3092 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040201 Bryant Ranch Prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63629-3115_cfbf97d7-5b31-45e9-bcfa-3491a4fa1095 63629-3115 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090605 ANDA ANDA040757 bryant ranch prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63629-3141_5fb4a750-ce07-07e3-f66a-46b027d5d03c 63629-3141 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20090630 NDA NDA021774 Bryant Ranch Prepack ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 63629-3142_ca386c45-4609-4bff-9bab-bdf0b879a7e4 63629-3142 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 Bryant Ranch Prepack ESZOPICLONE 3 mg/1 CIV 63629-3152_ef1f29ea-661d-41a6-9151-0f32bd513a16 63629-3152 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE ORAL 20030713 NDA AUTHORIZED GENERIC NDA020232 Bryant Ranch Prepack ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 63629-3158_5cf017c9-30f2-4d79-bcd5-3a7455f2404f 63629-3158 HUMAN PRESCRIPTION DRUG GlipizideER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031107 ANDA ANDA076467 Bryant Ranch Prepack GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 63629-3166_85186291-13a1-480f-aab0-b8a9127d7dfe 63629-3166 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 19551231 NDA AUTHORIZED GENERIC NDA010187 Bryant Ranch Prepack METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 63629-3177_7659e95b-e4d6-47d9-ba7e-18f46faab89c 63629-3177 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Bryant Ranch Prepack WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 63629-3178_f6474a45-db2e-4018-9bb7-9072e852ff7c 63629-3178 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090801 ANDA ANDA040748 bryant ranch prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63629-3183_5b526cb3-c4db-4b7c-9242-2c460d3e3e8d 63629-3183 HUMAN PRESCRIPTION DRUG HYZAAR losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-3184_d7c5fa6d-83a0-490f-bd52-1706de9dc475 63629-3184 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN TABLET ORAL 20100401 ANDA ANDA090177 bryant ranch prepack ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 650; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3190_9f40f44a-a64e-4015-a31c-99b3c241d0cf 63629-3190 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20060412 ANDA ANDA076502 Bryant Ranch Prepack FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 63629-3193_592041a1-4cac-006d-16bc-bc05066ab0c2 63629-3193 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20070701 ANDA ANDA077241 Bryant Ranch Rrepack BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 63629-3196_8ab5ad50-478b-4941-ae70-60ac345a4369 63629-3196 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100719 ANDA ANDA077455 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 63629-3197_89c34c1a-81da-49a5-99ad-a477c9c1546b 63629-3197 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 5 mg/1 63629-3198_8aa4ccd3-af36-4d98-ae7c-e01760f7c6d6 63629-3198 HUMAN PRESCRIPTION DRUG Etodolac etodolac TABLET, FILM COATED ORAL 19990421 ANDA ANDA075074 Bryant Ranch Prepack ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-3199_6c266e09-d27b-481f-b61a-820f8e93c4d9 63629-3199 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20110504 ANDA ANDA070791 Bryant Ranch Prepack DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 63629-3200_b1edf9f4-9df8-88cb-bfd1-e3500da58087 63629-3200 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 19861208 ANDA ANDA071108 Bryant Ranch Prepack FLURAZEPAM HYDROCHLORIDE 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-3201_80531c79-48cf-43e0-8312-056ea4812b7c 63629-3201 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20101206 ANDA ANDA091549 Bryant Ranch Prepack INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-3202_a1a8d3f3-86e9-4a8e-acd2-3b4c2a0d0043 63629-3202 HUMAN PRESCRIPTION DRUG Naprosyn Naproxen TABLET ORAL 20090901 ANDA ANDA075927 Bryant Ranch Prepack NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-3204_718fc3d1-961f-47ff-9da7-cff5cc61d27a 63629-3204 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Bryant Ranch Prepack NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 63629-3205_d45cc5a0-eb7d-4e43-853a-1b56e1ebbf26 63629-3205 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Bryant Ranch Prepack PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-3206_239d7d15-f00c-4fc0-abcb-530f039ea6df 63629-3206 HUMAN PRESCRIPTION DRUG Pentazocine and naloxone Pentazocine hydrochloride and naloxone hydrochloride TABLET ORAL 19970121 ANDA ANDA074736 Bryant Ranch Prepack NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE .5; 50 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIV 63629-3207_5a42b29a-d47a-4c3e-aeeb-d93415d715f9 63629-3207 HUMAN PRESCRIPTION DRUG Senna-Lax SENNOSIDES A AND B TABLET, FILM COATED ORAL 20110504 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack SENNOSIDES A AND B 8.6 mg/1 63629-3208_be4cc75d-61db-414d-b063-e47a978c8a6d 63629-3208 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 19900403 ANDA ANDA071795 Bryant Ranch Prepack SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-3209_5909fa53-4fa0-78de-e99b-9d5c5edf1d6e 63629-3209 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Bryant Ranch Prepack TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 63629-3210_5f513c7a-962f-4318-9bce-38fb05e1c39c 63629-3210 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110120 ANDA ANDA071524 Bryant Ranch Prepack TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 63629-3211_6f5c7a75-e1fd-40c4-b11c-f3b04f71e6b3 63629-3211 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120815 ANDA ANDA040887 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 63629-3213_46cf4dc6-32f8-47d6-95c0-3de5b5b2fa78 63629-3213 HUMAN OTC DRUG EXTRA STRENGTH STOOL SOFTENER LAXATIVE DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120329 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack DOCUSATE SODIUM 250 mg/1 63629-3217_af9fe725-452d-4ec2-8ff1-d88ad95bad52 63629-3217 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleate and Hydrochlorothiazide TABLET ORAL 20010918 ANDA ANDA075788 Bryant Ranch Prepack ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-3221_b5f3c852-4134-4279-88eb-3919c60c44e1 63629-3221 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20121018 ANDA ANDA070791 Bryant Ranch Prepack DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 63629-3226_6c27a8e1-c7ed-4b63-8285-9d1745564f39 63629-3226 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20111003 ANDA ANDA075768 Bryant Ranch Prepack BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-3233_e5bb3f03-2b7e-4885-b59c-f3eb1a4d9e1f 63629-3233 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 63629-3243_66f66c9c-7fde-45cd-af65-cb9a4fe690b8 63629-3243 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20020710 ANDA ANDA076095 Bryant Ranch Prepack MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 63629-3248_cc7edb93-c277-4960-891f-e0fcc4b390a3 63629-3248 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Bryant Ranch Prepack MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-3279_3d40a0bf-21c0-423b-bff8-e8b719345b9e 63629-3279 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 20100201 ANDA ANDA040300 bryant ranch prepack METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 63629-3289_67202808-6a4f-05ba-60cf-60f5a1b2ff57 63629-3289 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 Bryant Ranch Prepack SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-3291_ba95f1da-be23-4b47-857d-0404b6394a97 63629-3291 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 19971001 NDA NDA020639 Bryant Ranch Prepack QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 63629-3293_9bf67169-ce7a-4ea5-a6fb-78dd37863c62 63629-3293 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060317 ANDA ANDA077634 Bryant Ranch Prepack ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-3294_f33793c4-ada4-4a4a-bd1e-fcfbdf27e42f 63629-3294 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Bryant Ranch Prepack TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-3296_46c54d09-775c-47ff-87ba-f6728e990c4b 63629-3296 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Bryant Ranch Prepack RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 63629-3301_1447369e-b9af-4f1f-bab8-9e0645071227 63629-3301 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 19981002 NDA NDA020998 Bryant Ranch Prepack CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-3308_a372953f-4c60-4ac9-90b4-650e5f691b75 63629-3308 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Bryant Ranch Prepack ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-3309_95ac2a2e-6f38-43ac-9a56-b45392b10945 63629-3309 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 Bryant Ranch Prepack SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-3311_70584b50-54a4-42ed-84d8-3378ce4d7f6b 63629-3311 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010319 NDA NDA021153 Bryant Ranch Prepack ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 63629-3312_3cba65f5-8804-11d0-b97e-62b284597f87 63629-3312 HUMAN PRESCRIPTION DRUG FLUOXETINE fluoxetine hydrochloride CAPSULE ORAL 20081208 ANDA ANDA076922 Bryant Ranch Prepack FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-3313_41539934-9a65-4351-b47e-8589b8538dc5 63629-3313 HUMAN PRESCRIPTION DRUG Sertraline hydrochloride Sertraline hydrochloride TABLET, FILM COATED ORAL 20070905 ANDA ANDA077765 Bryant Ranch Prepack SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-3314_d283d5e7-5d1d-45c3-a72f-9cec00f19d4b 63629-3314 HUMAN PRESCRIPTION DRUG Effexor XR VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-3316_dfc53c5c-3d37-4daf-b87a-2fe7c8815663 63629-3316 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081126 ANDA ANDA077715 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 63629-3317_f192e998-09a7-4a8d-a92d-b53cd7c2339a 63629-3317 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20041112 ANDA ANDA077032 Bryant Ranch Prepack CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-3318_804a4d12-fb9c-857d-11d4-f9ed26b40a9c 63629-3318 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Bryant Ranch Prepack ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-3319_22615468-026e-4984-b3b8-a7870dd34469 63629-3319 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20030630 NDA NDA020639 Bryant Ranch Prepack QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 63629-3321_239edb0e-3f65-4419-b88f-f6eba4890bf7 63629-3321 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 Bryant Ranch Prepack TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-3323_3d36ecb5-4c38-43df-b3e2-a3dad6056d74 63629-3323 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20100511 ANDA ANDA079098 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-3324_f1b19fac-8052-45ef-9a02-0864205eb86e 63629-3324 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-3325_0e6e024c-edd6-41f0-bf0c-8967444008c0 63629-3325 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100628 ANDA ANDA076565 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-3326_b07691bd-ef9a-4b8d-8f2a-78f9f8551a03 63629-3326 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Bryant Ranch Prepack MIRTAZAPINE 30 mg/1 63629-3327_e26b08a4-e80e-4945-a786-958760214b3b 63629-3327 HUMAN PRESCRIPTION DRUG PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100913 NDA NDA020936 Bryant Ranch Prepack PAROXETINE HYDROCHLORIDE HEMIHYDRATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-3328_cc7edb93-c277-4960-891f-e0fcc4b390a3 63629-3328 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Bryant Ranch Prepack MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-3332_a6909571-0b84-f0b4-8df2-0b143c407482 63629-3332 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041203 ANDA ANDA076711 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 63629-3333_9b5795db-c2a0-4147-b368-6bdefb796004 63629-3333 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20101223 ANDA ANDA075022 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 30 mg/1 63629-3337_ec4cd107-382c-fa0c-41a4-15bce73182f0 63629-3337 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20090630 NDA NDA021774 Bryant Ranch Prepack ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 63629-3338_cb38f023-d914-4062-b267-1c236676a552 63629-3338 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20041112 ANDA ANDA077032 Bryant Ranch Prepack CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-3339_c7ac8dc4-826a-4edf-b221-cb3273d29a02 63629-3339 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Bryant Ranch Prepack CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-3340_22d181d1-1e10-4fd0-a11b-def9e9434b37 63629-3340 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20100115 NDA NDA021427 Bryant Ranch Prepack DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-3341_f61bdede-243e-4bfe-9772-059c8103c96c 63629-3341 HUMAN PRESCRIPTION DRUG dicyclomine hydrochloride dicyclomine hydrochloride CAPSULE ORAL 19970228 ANDA ANDA040204 Bryant Ranch Prepack DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 63629-3343_c4070400-b81f-451e-9fd7-83fd26010ef4 63629-3343 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20090107 ANDA ANDA040766 Bryant Ranch Prepack HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 63629-3344_d3768f5e-f8a7-434a-a53b-4b4ac80d74b2 63629-3344 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20101004 ANDA ANDA078385 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-3345_70e814a4-4ed1-4210-8093-2b9ea5a1cc21 63629-3345 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030601 ANDA ANDA076312 Bryant Ranch Prepack MIRTAZAPINE 15 mg/1 63629-3346_2a71b322-489d-48de-8430-22d17f6aeb4c 63629-3346 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Bryant Ranch Prepack MIRTAZAPINE 45 mg/1 63629-3347_14506e4a-c387-4e81-9a5a-5d75882a555c 63629-3347 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010319 NDA NDA021153 Bryant Ranch Prepack ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 63629-3348_2974b1cf-8586-4234-b7cf-d438c3692dd7 63629-3348 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Bryant Ranch Prepack PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-3349_0910da56-7686-0abd-5fe2-8976742db705 63629-3349 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Bryant Ranch Prepack PAROXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-3353_e0de4498-cabf-44b6-b067-52756eef0577 63629-3353 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071219 ANDA ANDA077056 Bryant Ranch Prepack PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 63629-3354_3276b534-fe02-4c14-896b-06da671494ea 63629-3354 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Bryant Ranch Prepack RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 63629-3355_e6145216-e417-43b1-bca3-da2e61393567 63629-3355 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Bryant Ranch Prepack RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 63629-3357_3c204042-bc29-4cd3-a623-e91c4f03f15f 63629-3357 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 Bryant Ranch Prepack OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-3359_e931b48a-658d-4a2e-9e63-7094421d29c7 63629-3359 HUMAN PRESCRIPTION DRUG ARTHROTEC diclofenac sodium and misoprostol TABLET, FILM COATED ORAL 19971224 NDA NDA020607 Bryant Ranch Prepack DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 63629-3362_64bd3a24-ec9f-4f9b-8739-30abcca9aed0 63629-3362 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 63629-3366_169bfb87-147c-4353-a2ce-9e6b7516b489 63629-3366 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20000407 NDA NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-3367_45e9d213-6e5f-46ef-8512-c4aa0fce1b19 63629-3367 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Bryant Ranch Prepack PREGABALIN 50 mg/1 CV 63629-3369_bdd07e66-5879-4968-ac71-7fa033425b0c 63629-3369 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Bryant Ranch Prepack PREGABALIN 100 mg/1 CV 63629-3370_2fc29131-501a-4672-8aaa-d37ff3558abf 63629-3370 HUMAN PRESCRIPTION DRUG Depakote ER Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20100607 NDA NDA021168 Bryant Ranch Prepack DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 63629-3371_2b1eb1f5-fce8-40ef-930f-3b796f1281c2 63629-3371 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Bryant Ranch Prepack VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-3372_ce96bc99-e5ef-4e96-86d0-784fbe7cbac1 63629-3372 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20080515 NDA NDA021400 Bryant Ranch Prepack VARDENAFIL HYDROCHLORIDE TRIHYDRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 63629-3373_9333d442-f542-4d05-a649-60f6608e56f0 63629-3373 HUMAN PRESCRIPTION DRUG AVAPRO IRBESARTAN TABLET ORAL 19970930 NDA NDA020757 Bryant Ranch Prepack IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-3375_e0433fa2-3f9d-4f22-bd66-f6ad0640d240 63629-3375 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET, FILM COATED ORAL 20060824 ANDA ANDA077525 Bryant Ranch Prepack GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-3376_a63b4de7-fab8-4674-8f93-af560b9cb763 63629-3376 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914 NDA NDA020838 Bryant Ranch Prepack CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-3377_291aba2e-f44d-4823-97f8-0cc13499647b 63629-3377 HUMAN PRESCRIPTION DRUG ATACAND HCT Candesartan cilexetil and Hydrochlorothiazide TABLET ORAL 20000928 NDA NDA021093 Bryant Ranch Prepack CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-3378_fc4247a0-dc24-49ea-8798-3f3cc20fea03 63629-3378 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 19971001 NDA NDA020639 Bryant Ranch Prepack QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 63629-3379_33c3e856-433b-4bf2-b47c-0244aa14edd3 63629-3379 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20001113 NDA NDA020639 Bryant Ranch Prepack QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 63629-3380_1d454bae-1545-4c55-abd5-7ee56097229b 63629-3380 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20060213 NDA NDA020639 Bryant Ranch Prepack QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 63629-3381_6d611956-c43b-4178-9f6c-ef44de100fe6 63629-3381 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA021366 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-3383_842e2bc8-1608-4ff6-87cf-5a007182226c 63629-3383 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20031016 NDA NDA021487 Bryant Ranch Prepack MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 63629-3384_476fabdd-0e1a-466c-ad4c-d44e9de88665 63629-3384 HUMAN PRESCRIPTION DRUG Flomax tamsulosin hydrochloride CAPSULE ORAL 19970912 NDA NDA020579 Bryant Ranch Prepack TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 63629-3385_7a11aeee-5177-456d-a949-11bfe797cdcb 63629-3385 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Bryant Ranch Prepack SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-3386_4e27fec8-81ff-42c9-b923-d0e314940e78 63629-3386 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Bryant Ranch Prepack ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] 63629-3387_b45241d0-6aa8-44f3-b429-039e4a52d2ad 63629-3387 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Bryant Ranch Prepack ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] 63629-3388_37fe9d1c-8a4c-4b48-8008-3fe346007084 63629-3388 HUMAN PRESCRIPTION DRUG PROVIGIL modafinil TABLET ORAL 19981224 NDA NDA020717 Bryant Ranch Prepack MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 63629-3389_c5598a3d-3157-43aa-aa41-cd64597b51d8 63629-3389 HUMAN PRESCRIPTION DRUG Rozerem ramelteon TABLET, FILM COATED ORAL 20050722 NDA NDA021782 Bryant Ranch Prepack RAMELTEON 8 mg/1 Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA] 63629-3390_aa41c784-2ca3-4c6d-8df2-a38714fbadd8 63629-3390 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 Bryant Ranch Prepack OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-3392_4a0da02d-fde4-4483-bbff-43943a40b8b7 63629-3392 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Bryant Ranch Prepack SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-3393_48786044-f8cf-4de3-a337-dfcfe201382a 63629-3393 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Bryant Ranch Prepack SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-3405_9e98e497-49a9-4771-bfeb-836a5cd224a6 63629-3405 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Bryant Ranch Prepack ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 63629-3408_0957f548-1286-47c8-89e1-ddd41880d6b6 63629-3408 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Bryant Ranch Prepack SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-3449_f2d8f10e-aa40-4678-814d-c95e881d7770 63629-3449 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20050407 ANDA ANDA075310 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 63629-3475_4d2a03aa-a083-4738-a715-dfa45c798136 63629-3475 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 19920201 NDA NDA019962 Bryant Ranch Prepack METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-3545_f22389d3-ea5a-46bb-8a26-852a7080e56f 63629-3545 HUMAN PRESCRIPTION DRUG PreNatal Vitamins Plus PreNatal Vitamins Plus TABLET ORAL 20110415 UNAPPROVED DRUG OTHER Bryant Ranch Prepack .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; ZINC 22; 120; 200; 400; 2; 12; 1; 27; 20; 10; 3; 1.84; 4000; 25 mg/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 63629-3548_7773ba02-33ee-496c-a3a1-3299a5769ad0 63629-3548 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Bryant Ranch Prepack ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 63629-3549_e12670b2-5088-4065-a447-171424f27f62 63629-3549 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Bryant Ranch Prepack ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 63629-3551_2bef5b11-3f33-402c-a51e-cc38497042d6 63629-3551 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19900930 ANDA ANDA089807 Bryant Ranch Prepack THEOPHYLLINE ANHYDROUS 100 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 63629-3552_7aab61e3-8550-44ea-9bdd-8925c8409b01 63629-3552 HUMAN PRESCRIPTION DRUG Rimantadine Hydrochloride Rimantadine Hydrochloride TABLET, FILM COATED ORAL 20050401 ANDA ANDA076132 Bryant Ranch Prepack RIMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 63629-3561_d0ce2c41-8eb8-4d1d-ace5-6ffa69f65d19 63629-3561 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Bryant Ranch Prepack FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 63629-3563_54fae935-fb40-4def-b552-1e34d6437e77 63629-3563 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA076939 Bryant Ranch Prepack PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-3564_4f7c71ff-60c7-4694-85db-972b105fc49a 63629-3564 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63629-3566_0d5ef5dc-83e4-48d1-b4ea-8bf5b76e6e1e 63629-3566 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 19920201 NDA NDA019962 Bryant Ranch Prepack METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-3587_46420ed0-86f7-4f1b-bcf2-5927b8d66413 63629-3587 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070178 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-3597_0ffce665-78b3-4840-b281-f0bccec395a0 63629-3597 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085971 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 63629-3610_2eee0905-67c1-4914-98de-0dba44341bf1 63629-3610 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 19950801 NDA NDA020487 Bryant Ranch Prepack VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63629-3632_336edf41-e455-4672-a319-5ea304d18f06 63629-3632 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 19961125 NDA NDA020690 Bryant Ranch Prepack DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 63629-3633_e1382f77-a000-4f83-88e4-a7ae08da5d58 63629-3633 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19970623 NDA NDA020592 Bryant Ranch Prepack OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 63629-3636_a95f60c6-a833-466d-a6b9-143ea8a26f19 63629-3636 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 19920201 NDA NDA019962 Bryant Ranch Prepack METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-3638_1e1be244-a358-46ba-86c5-f165d4a6869c 63629-3638 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070801 ANDA ANDA078314 Bryant Ranch Prepack NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-3639_2611d6ae-c91b-4eb0-9908-51e6ffb20e86 63629-3639 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20050915 ANDA ANDA077314 Bryant Ranch Prepack NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63629-3640_2641602f-1ff2-4ee7-9d4d-05f81682de53 63629-3640 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 Bryant Ranch Prepack CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63629-3642_8087eb83-e065-423d-adc8-703ba2bc5f02 63629-3642 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 20110118 ANDA ANDA073516 Bryant Ranch Prepack KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-3645_ad6c6bcd-9d20-480e-9f12-cd8d2932227c 63629-3645 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880524 ANDA ANDA072100 Bryant Ranch Prepack DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 63629-3646_de5be906-6888-43d6-aea0-169ac24ce18d 63629-3646 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20000427 ANDA ANDA075731 Bryant Ranch Prepack CLORAZEPATE DIPOTASSIUM 3.75 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-3649_efdd1446-9970-4020-9401-05c2d9b590e4 63629-3649 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63629-3668_d12bc5b7-6d74-4744-bdf5-0d507f166071 63629-3668 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 Bryant Ranch Prepack CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 63629-3669_7380d9b8-9623-49b7-876c-b46767419218 63629-3669 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 Bryant Ranch Prepack CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 63629-3678_44fb1794-6e03-4313-b33b-72fc9619f9d0 63629-3678 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070524 ANDA ANDA076719 Bryant Ranch Prepack AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63629-3685_b958f1ba-ec85-4148-bff5-522b34dc2180 63629-3685 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE ORAL 20030828 ANDA ANDA076570 Bryant Ranch Prepack TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 63629-3701_a8054858-c322-4f42-ae25-127247706b57 63629-3701 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 19980220 NDA NDA020830 Bryant Ranch Prepack MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 63629-3707_0c17d356-ebc7-4476-a844-b1fffae3543e 63629-3707 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080936 Bryant Ranch Prepack ISONIAZID 100 mg/1 Antimycobacterial [EPC] 63629-3708_9c17ec04-0a0d-4ce9-a70f-9730ffd49ec8 63629-3708 HUMAN OTC DRUG Cetirizine Cetirizine Hydrochloride TABLET ORAL 20080116 ANDA ANDA078336 Bryant Ranch Prepack CETIRIZINE HYDROCHLORIDE 10 mg/1 63629-3711_d2a74d85-9cde-4bcb-8903-2dc5ee551be6 63629-3711 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086067 Bryant Ranch Prepack ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 63629-3730_e7eb17bd-a5a8-4151-b0d9-1f4ab2d5b3d6 63629-3730 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Asparatate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020211 ANDA ANDA040422 Bryant Ranch Prepack AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 63629-3731_7c473472-2e62-4927-ab80-b7201f066e17 63629-3731 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Suflate Dextroamphetamine Saccharate, Amphetamine Asparatate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20091218 ANDA ANDA040422 Bryant Ranch Prepack AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 63629-3738_30da1180-803c-4cc6-bd4b-7a49cc02443f 63629-3738 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Bryant Ranch Prepack ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 63629-3739_764f6b7a-6ce2-4c98-b9e8-8394614ddadd 63629-3739 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20061002 ANDA ANDA077912 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-3742_c71547cc-7e6e-4b06-a189-3d3bd98f75e8 63629-3742 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 Bryant Ranch Prepack DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63629-3748_7082a1ce-fef6-44e5-8ed9-753adc0cdaff 63629-3748 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20090817 ANDA ANDA040833 Bryant Ranch Prepack ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 63629-3750_71049b9a-da83-477d-a877-b427b52d3027 63629-3750 HUMAN PRESCRIPTION DRUG Afeditab CR Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021101 ANDA ANDA075659 Bryant Ranch Prepack NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63629-3755_68e7a453-9f0f-4414-8c78-0623a51b0df3 63629-3755 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Bryant Ranch Prepack ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 63629-3757_401d201f-c53d-441f-9614-e9218e34597f 63629-3757 HUMAN OTC DRUG Calcium carbonate Calcium carbonate TABLET ORAL 19990412 OTC MONOGRAPH FINAL part331 Bryant Ranch Prepack CALCIUM CARBONATE 648 mg/1 63629-3760_14c4c4ff-913b-4d12-a617-450cf58ca0bb 63629-3760 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 19971001 NDA NDA020658 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 63629-3762_45fa1a0a-5ee3-4cc2-b2cc-d7c12bed54a2 63629-3762 HUMAN PRESCRIPTION DRUG Budeprion Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20080530 ANDA ANDA077284 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 63629-3764_bf64d2ee-7ce2-447d-bf58-b957a4ee020c 63629-3764 HUMAN PRESCRIPTION DRUG AVINZA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20020320 NDA NDA021260 Bryant Ranch Prepack MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3765_ce103e45-81fc-453c-98a4-bb8ab39c98b2 63629-3765 HUMAN PRESCRIPTION DRUG AVINZA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20020320 NDA NDA021260 Bryant Ranch Prepack MORPHINE SULFATE 120 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3766_46391396-3a08-4be2-aa78-0c43510cfa29 63629-3766 HUMAN PRESCRIPTION DRUG AVINZA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20020320 NDA NDA021260 Bryant Ranch Prepack MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3767_f5ae7ebd-de28-439d-bf24-c0b313167cbc 63629-3767 HUMAN PRESCRIPTION DRUG AVINZA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20020320 NDA NDA021260 Bryant Ranch Prepack MORPHINE SULFATE 90 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3768_f6405586-3f10-422a-893a-88fdcab72664 63629-3768 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 19960213 ANDA ANDA040422 Bryant Ranch Prepack AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 63629-3769_1d0c5bc5-ab57-485b-b19b-e4fe47d97bbe 63629-3769 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 19960213 ANDA ANDA040422 Bryant Ranch Prepack AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 63629-3770_719aa19b-24b8-9a20-a00e-f6335ecd4b53 63629-3770 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20090401 ANDA ANDA040550 Bryant Ranch Prepack ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3771_eb842d04-3b59-40d8-9db8-7b34a1779066 63629-3771 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20090519 ANDA ANDA040517 Bryant Ranch Prepack METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3772_c16d1ad1-71fb-4e36-9704-a96dda997fa5 63629-3772 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3773_f8b7e42f-665e-4aba-a97b-4e847dfdacb6 63629-3773 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride and acetaminophen TABLET ORAL 19990730 ANDA ANDA040341 Bryant Ranch Prepack ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3774_94a64cc4-59ee-456b-a5dd-821d57e3d023 63629-3774 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3776_6a486e80-1f8b-4bb8-962f-2bf70ad48a0c 63629-3776 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride and acetaminophen TABLET ORAL 19990730 ANDA ANDA040341 Bryant Ranch Prepack ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 650; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3783_fa3d7d29-4851-427e-9444-11a02216cad5 63629-3783 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 19950401 UNAPPROVED DRUG OTHER Bryant Ranch Prepack SALSALATE 750 mg/1 63629-3786_f64a6e8f-d32b-48b8-a665-ba2435c61468 63629-3786 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 Bryant Ranch Prepack ESZOPICLONE 2 mg/1 CIV 63629-3788_110cdf1e-6043-48b3-9288-9f70656a2637 63629-3788 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20090519 ANDA ANDA040517 Bryant Ranch Prepack METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3789_8f8098ab-fc5b-4487-b8af-ec62403c664f 63629-3789 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080317 NDA NDA022207 Bryant Ranch Prepack MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3791_e7ca6d2c-2549-48af-9d10-778ca232d546 63629-3791 HUMAN PRESCRIPTION DRUG Methergine methylergonovine maleate TABLET, COATED ORAL 19461119 NDA NDA006035 Bryant Ranch Prepack METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 63629-3795_f371d693-979d-4479-be3b-5d30a93a5994 63629-3795 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 20100602 ANDA ANDA075227 Bryant Ranch Prepack NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-3798_518bb1a5-c033-fd4c-02e0-f3dfe46dde94 63629-3798 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE Hydromorphone Hydrochloride TABLET ORAL 20091123 NDA NDA019892 Bryant Ranch Prepack HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3803_e4355d25-edd6-4289-b54e-c3b222f13a1a 63629-3803 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE ORAL 20101215 NDA AUTHORIZED GENERIC NDA200534 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3807_0bb83f5d-2ac1-a07e-0200-ee5086ba1985 63629-3807 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090918 ANDA ANDA090429 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 63629-3816_5c0405d8-b3e6-4cc1-83b5-ae9fbcf50bcd 63629-3816 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20080111 ANDA ANDA078069 Bryant Ranch Prepack OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-3858_1012b2db-17ff-4f67-abe9-bc48c5c2dc06 63629-3858 HUMAN PRESCRIPTION DRUG Clorazepate dipotassium Clorazepate dipotassium TABLET ORAL 20050114 ANDA ANDA076911 Bryant Ranch Prepack CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-3859_d42b3b3a-fe63-40d9-acc1-90a515a03969 63629-3859 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20000427 ANDA ANDA075731 Bryant Ranch Prepack CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-3861_07a1bce7-078a-4586-85a5-20fa413314d3 63629-3861 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3868_01ffbc56-3e5f-4b71-b511-92f03bf0a60b 63629-3868 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Bryant Ranch Prepack CIPROFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 63629-3870_8f05a130-4eee-4acf-9cf0-03fc9d1b439f 63629-3870 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 Bryant Ranch Prepack DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 63629-3906_feb24692-8b43-4789-b895-0a78bee50338 63629-3906 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080501 NDA NDA020859 Bryant Ranch Prepack ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 63629-3910_448b3e50-18ea-438d-95f3-fa7015458a26 63629-3910 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 Bryant Ranch Prepack METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63629-3941_0c4be953-acec-4b92-ab21-d7e2aec9e818 63629-3941 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, EXTENDED RELEASE ORAL 20040302 ANDA ANDA075910 Bryant Ranch Prepack DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-3953_66cca5ba-3228-49f0-934e-715c9fe4e784 63629-3953 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20090806 ANDA ANDA090177 Bryant Ranch Prepack ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3961_946b00d2-ffe8-4f2e-a7b4-f067fd6a7d6b 63629-3961 HUMAN OTC DRUG Rugby Nasal Decongestant Pseudoephedrine Hydrochloride LIQUID ORAL 19990726 OTC MONOGRAPH FINAL part341 Bryant Ranch Prepack PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5mL 63629-3973_d4f70d5b-72b3-4445-bd37-bda34397d948 63629-3973 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20060412 ANDA ANDA076502 Bryant Ranch Prepack FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 63629-3975_dcc5e14d-4457-4f06-8113-15e533536803 63629-3975 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE Extended-Release MORPHINE SULFATE TABLET ORAL 20101021 ANDA ANDA076412 Bryant Ranch Prepack MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3976_3cd79db8-41b4-0087-4a0f-a2acd02f5edb 63629-3976 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100326 ANDA ANDA074862 bryant ranch prepack MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3979_6302daf7-8b23-4633-ab2b-f7b7dc9f02b5 63629-3979 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate Extended Release TABLET ORAL 20100318 ANDA ANDA076412 bryant ranch prepack MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-3981_9c4d09d1-18e8-45b8-8282-8a95f9c96501 63629-3981 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 Bryant Ranch Prepack LEVOFLOXACIN 500 mg/1 63629-3982_291423bd-d8d3-4438-935c-f131dc57523a 63629-3982 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 20020812 NDA NDA020487 Bryant Ranch Prepack VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63629-3990_23137b83-c2a1-4cd4-83a4-c859a5305ce3 63629-3990 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880620 ANDA ANDA072103 Bryant Ranch Prepack DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 63629-3994_de0cf218-a4dd-4d8a-99e6-521989e82684 63629-3994 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20090327 ANDA ANDA079162 Bryant Ranch Prepack TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-3995_6039fd1b-5061-4071-aba3-2da49374f26c 63629-3995 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET ORAL 20090327 ANDA ANDA079162 Bryant Ranch Prepack TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-3998_91f3f222-8729-435d-8fd4-5a810c1d4a09 63629-3998 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20070614 ANDA ANDA076345 Bryant Ranch Prepack GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 63629-4000_2d09e345-10b4-7d59-ee6c-4ff91e2e505f 63629-4000 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20090601 ANDA ANDA090659 bryant ranch prepack OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4008_97635cc5-cd1c-49f2-870f-9be59c6d4101 63629-4008 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20080722 OTC MONOGRAPH FINAL part336 Bryant Ranch Prepack MECLIZINE HYDROCHLORIDE 25 mg/1 63629-4010_ec2d5704-0e02-47a9-9ab8-45a23ec0327f 63629-4010 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Immediate-Release Diethylpropion hydrochloride TABLET ORAL 20080101 NDA NDA011722 Bryant Ranch Prepack DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 63629-4014_6e8c4d20-7f6e-5278-06cb-d3c9e99a0173 63629-4014 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Bryant Ranch Prepack ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63629-4017_ce04f68d-cdb3-4656-83fc-0bd2ff375f3e 63629-4017 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Bryant Ranch Prepack WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 63629-4018_35bdccd7-08c5-41e5-81ae-e8d6be510c5a 63629-4018 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 20110503 ANDA ANDA070541 Bryant Ranch Prepack CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 63629-4023_bc2b3710-dcac-4154-a000-85d585183d6b 63629-4023 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Bryant Ranch Prepack ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63629-4026_f23998a2-de80-4ffb-9241-11c609a14632 63629-4026 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20000101 UNAPPROVED DRUG OTHER Bryant Ranch Prepack PHENOBARBITAL 15 mg/1 CIV 63629-4027_831e814e-99f1-41a8-97e9-8a582d631fc6 63629-4027 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20101206 ANDA ANDA084769 Bryant Ranch Prepack CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-4028_897164c4-714d-4b8a-8b6a-9ffc7f3627a0 63629-4028 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine and naloxone FILM, SOLUBLE SUBLINGUAL 20100913 NDA NDA022410 Bryant Ranch Prepack BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 63629-4034_614f49fb-4133-4949-81fb-15ea64d737dd 63629-4034 HUMAN PRESCRIPTION DRUG suboxone buprenorphine hydrochloride and naloxone hydrochloride TABLET ORAL 20090723 NDA NDA020733 Bryant Ranch Prepack BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 63629-4037_3f34e720-17fa-4aae-8ab6-7de46958d780 63629-4037 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20110308 ANDA ANDA075536 Bryant Ranch Prepack DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 63629-4042_136d8d98-acb0-4cc9-aee3-0cbe3921e6f1 63629-4042 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 19970528 ANDA ANDA064150 Bryant Ranch Prepack RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 63629-4053_32aa1074-1b00-5d7c-b1b0-3c0cc9720fd3 63629-4053 HUMAN PRESCRIPTION DRUG Childrens Silapap Acetaminophen LIQUID ORAL 19940905 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ACETAMINOPHEN 160 mg/5mL 63629-4057_d43c13e4-f617-4fcd-a524-3d154feca552 63629-4057 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101230 ANDA ANDA075665 Bryant Ranch Prepack ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-4060_15b58b77-d9cc-4349-9c1d-04a05a8dbfb7 63629-4060 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Bryant Ranch Prepack CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 63629-4061_ff45808a-31a6-4880-bec7-4a799a28f097 63629-4061 HUMAN PRESCRIPTION DRUG ALPRAZOLAM EXTENDED-RELEASE ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070328 ANDA ANDA077996 Bryant Ranch Prepack ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-4068_d75d0d48-2e49-41cd-8690-1b33ffb85ad3 63629-4068 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN TABLET ORAL 20090904 ANDA ANDA040535 Bryant Ranch Prepack ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4070_4e6ffe0d-525c-4276-be36-2ff8fcb0daca 63629-4070 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Bryant Ranch Prepack CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 63629-4071_6e6cf9e4-16bd-40ac-91ea-c03e51d2cc0e 63629-4071 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031101 ANDA ANDA076467 Bryant Ranch Prepack GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 63629-4072_8b4d4bd5-02f5-4a14-b6b2-131485514bed 63629-4072 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20000925 ANDA ANDA075579 Bryant Ranch Prepack BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-4073_a6a3fae8-bb46-49ae-8212-786db1b377e9 63629-4073 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100420 ANDA ANDA074330 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63629-4075_01d906d4-67f7-4720-9147-c236ba5683d1 63629-4075 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20000925 ANDA ANDA075579 Bryant Ranch Prepack BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-4089_3d13bbbc-ace1-4561-8d1d-333b60af6cce 63629-4089 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, EXTENDED RELEASE ORAL 20091005 ANDA ANDA075128 bryant ranch prepack NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63629-4092_50924708-d935-4e10-825c-b6d340c81efa 63629-4092 HUMAN PRESCRIPTION DRUG Buprenorphine hydrochloride Buprenorphine hydrochloride TABLET ORAL 20091009 ANDA ANDA020732 bryant ranch prepack BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII 63629-4093_2d5483f5-a2a6-4b80-ad9f-78b1562a0e94 63629-4093 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Bryant Ranch Prepack ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63629-4094_750c2943-bfc8-4022-907b-5c8e46b01bf5 63629-4094 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19860723 ANDA ANDA089424 Bryant Ranch Prepack SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 63629-4096_0b311e9e-302d-4f18-b4eb-4a6a904357d8 63629-4096 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Bryant Ranch Prepack METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-4099_c9a663f9-708e-4b80-865d-5f3a32864f84 63629-4099 HUMAN PRESCRIPTION DRUG butalbital, acetominophen and caffeine butalbital, acetominophen and caffeine TABLET ORAL 20090427 ANDA ANDA040883 Bryant Ranch Prepack ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 63629-4108_3d1e0f90-02f8-4a0e-81cf-732e55a634ae 63629-4108 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 20100121 ANDA ANDA075219 Bryant Ranch Prepack DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-4112_75eaf6c9-b57b-4880-ab58-372c2fa3ac27 63629-4112 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 19910731 ANDA ANDA073191 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-4121_427b120a-cfda-447a-bcf5-e56635ea49df 63629-4121 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040742 Bryant Ranch Prepack BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 63629-4122_68b4b569-e7c6-4582-9aab-67e9129bcd6d 63629-4122 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20100329 ANDA ANDA040145 Bryant Ranch Prepack WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 63629-4123_04c1d597-e0c5-4c78-901b-7eec39a54a7b 63629-4123 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Bryant Ranch Prepack CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 63629-4125_f4ad4843-f0b4-4ee9-9c39-ccfd7f7b35b6 63629-4125 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET, FILM COATED ORAL 20100312 ANDA ANDA075897 Bryant Ranch Prepack FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-4126_50ddeea2-ca53-47b2-9e6a-3ea235343df8 63629-4126 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 Bryant Ranch Prepack BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 63629-4127_4282fdce-3ff7-443f-b4a9-815e14d35c69 63629-4127 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20060707 ANDA ANDA084610 Bryant Ranch Prepack DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63629-4129_1ce1550d-5ffd-4e5d-a874-d70efe28f327 63629-4129 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750603 ANDA ANDA084613 Bryant Ranch Prepack DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63629-4137_3fc5c233-2c76-48ab-90a8-d0c20ade6336 63629-4137 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Bryant Ranch Prepack LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-4139_c09c2424-b088-4211-bd2e-67a10602fd92 63629-4139 HUMAN PRESCRIPTION DRUG Benzphetamine Hydrochloride Benzphetamine Hydrochloride TABLET ORAL 20100201 ANDA ANDA040845 bryant ranch prepack BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 63629-4141_8175fe34-c105-4b41-a2ef-e0d4ee2141ec 63629-4141 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20101102 ANDA ANDA075124 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63629-4143_8cb19af7-54e2-48e2-942d-c13fce0d86a7 63629-4143 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 19951121 20150616 NDA NDA020564 Bryant Ranch Prepack LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 63629-4144_893ecc5d-b958-4865-b6a9-e5660b68fa3d 63629-4144 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20050919 ANDA ANDA077267 Bryant Ranch Prepack ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 63629-4145_a5d93feb-c4c4-4c8a-855d-f9b54d0d1fe4 63629-4145 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20080107 NDA NDA021368 Bryant Ranch Prepack TADALAFIL 2.5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 63629-4146_2d98fffd-516c-481d-8736-6aea6add2dc3 63629-4146 HUMAN PRESCRIPTION DRUG NAPRELAN naproxen sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960105 NDA NDA020353 Bryant Ranch Prepack NAPROXEN SODIUM 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-4148_dad5c28b-695e-4bc1-8d0b-be04b355e568 63629-4148 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Bryant Ranch Prepack DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-4151_d85027cd-f6bc-419c-9190-7a263ce441fb 63629-4151 HUMAN PRESCRIPTION DRUG lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091111 NDA AUTHORIZED GENERIC NDA020406 Bryant Ranch Prepack LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 63629-4153_cbb391b5-f1fb-4dd9-a17d-a32456c1c513 63629-4153 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20100304 ANDA ANDA076636 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4155_4f92eca1-edf5-4b22-a66e-69c549dda71f 63629-4155 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride CAPSULE ORAL 20100308 ANDA ANDA077712 bryant ranch prepack OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4159_a52c89f4-5c22-4b3d-bde8-5bd3ad8c4723 63629-4159 HUMAN PRESCRIPTION DRUG AVAPRO IRBESARTAN TABLET ORAL 19970930 NDA NDA020757 Bryant Ranch Prepack IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-4169_5403833d-40c7-4eea-8fb4-6c3735cac048 63629-4169 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 Bryant Ranch Prepack LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 63629-4170_e58e8417-b769-4111-ab90-e0823d62ac8a 63629-4170 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20030301 ANDA ANDA076243 Bryant Ranch Prepack LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 63629-4171_bb4e4ea5-fe2a-4320-b0cc-2dcc4b1a5b96 63629-4171 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 Bryant Ranch Prepack LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 63629-4173_5b79717f-7833-499a-a09a-5363b79714a7 63629-4173 HUMAN PRESCRIPTION DRUG OPANA Oxymorphone Hydrochloride TABLET ORAL 20060626 NDA NDA021611 Bryant Ranch Prepack OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4174_b0d683e0-ee2e-4a82-8ae5-fec301c8167b 63629-4174 HUMAN PRESCRIPTION DRUG Opana ER OXYMORPHONE HYDROCHLORIDE TABLET ORAL 20101231 NDA NDA021610 Bryant Ranch Prepack OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4175_0dd16e22-e5ca-4960-a42f-86737e0a7689 63629-4175 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080317 NDA NDA022207 Bryant Ranch Prepack MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4177_b8bdd68c-ac5d-4244-b9d9-1818cafa9674 63629-4177 HUMAN PRESCRIPTION DRUG OPANA ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20060630 NDA NDA021610 Bryant Ranch Prepack OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4179_5fe2bf15-2e04-301a-f300-c5d01a3a551c 63629-4179 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20090601 NDA NDA022304 Bryant Ranch Prepack TAPENTADOL HYDROCHLORIDE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 63629-4181_7c1b01cd-a2dc-45ec-a4e3-ffb74a981411 63629-4181 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Bryant Ranch Prepack PREGABALIN 150 mg/1 CV 63629-4183_d3a667be-a64b-4f56-82d4-d4988c282bf0 63629-4183 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 Bryant Ranch Prepack LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 63629-4184_b46df43b-3d14-4cc2-8695-69e229302b59 63629-4184 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20090302 ANDA ANDA077712 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4185_032220f5-0324-e3e9-1289-aa3b7d1bf09f 63629-4185 HUMAN PRESCRIPTION DRUG Divalproex Sodium Delayed-Release Divalproex Sodium TABLET, FILM COATED ORAL 20091130 ANDA ANDA090210 Bryant Ranch Prepack DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 63629-4191_4cb3eadc-8bd5-46b4-8ca8-ec43b5810a38 63629-4191 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Bryant Ranch Prepack MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4203_aa97fa0e-0afa-401c-8364-f345aad1a055 63629-4203 HUMAN PRESCRIPTION DRUG Good Sense Heartburn Relief Cimetidine TABLET ORAL 20021230 ANDA ANDA075285 Bryant Ranch Prepack CIMETIDINE 200 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63629-4205_6a23559f-eb3f-495e-89cd-8dd8c935cf6d 63629-4205 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 Bryant Ranch Prepack METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63629-4207_4684684f-ee27-4287-a389-4908b3b18b51 63629-4207 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19910830 ANDA ANDA081079 Bryant Ranch Prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63629-4238_40184b18-aa6a-4583-af0c-afdcb2e02bb5 63629-4238 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Bryant Ranch Prepack LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-4241_7044b9e8-9291-44eb-af00-0504f039bb93 63629-4241 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Bryant Ranch Prepack METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-4244_3785e70e-ccc0-3794-adae-d09b6ed66426 63629-4244 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63629-4245_2b8d7ff8-709c-4df8-82ab-dd627dac3f69 63629-4245 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63629-4251_03c9abf0-e19e-ce73-29d2-6a57e488fa3a 63629-4251 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20071001 NDA NDA021116 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 63629-4273_650fc428-317a-4299-92b1-63f711f5f390 63629-4273 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130104 ANDA ANDA040148 Bryant Ranch Prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63629-4276_320c594c-99eb-454b-b3a7-fc4e5f390cfa 63629-4276 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20101103 ANDA ANDA074132 Bryant Ranch Prepack NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 63629-4278_1c7b06b3-33df-4423-8ca2-c2327db50038 63629-4278 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078790 Bryant Ranch Prepack DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 63629-4279_6197078c-e52b-4526-b9db-773ff66e4683 63629-4279 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20110211 ANDA ANDA074260 Bryant Ranch Prepack CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 63629-4284_601ea012-0d60-41d7-9fa2-b556ab5f09dd 63629-4284 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091123 NDA AUTHORIZED GENERIC NDA019892 Bryant Ranch Prepack HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4298_9a07b3da-a2c4-4736-90af-2284d67dccf4 63629-4298 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE ORAL 20110106 ANDA ANDA070944 Bryant Ranch Prepack OXAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-4302_b5c1b851-e515-44ea-a1f4-8e8df75814b5 63629-4302 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040715 Bryant Ranch Prepack BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 63629-4304_a5e53c33-6442-4993-bfc9-b52d7bbb63de 63629-4304 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 63629-4305_e5acb535-9120-4728-9633-187c86d5d484 63629-4305 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Bryant Ranch Prepack CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 63629-4306_c6420acb-0f21-426c-af33-0c41ebc20c4a 63629-4306 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Bryant Ranch Prepack ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63629-4311_6da3d52a-58d0-419a-ab33-e42052c0379e 63629-4311 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-4331_a8685718-f5c6-4d21-9fdc-becc809a22e9 63629-4331 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20100707 ANDA ANDA040350 Bryant Ranch Prepack METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 63629-4335_7c1e835e-80a6-4743-afd5-3dddc0679133 63629-4335 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63629-4337_57c103e0-d723-0031-b263-f02d7b8fc35b 63629-4337 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070994 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63629-4338_d00601cb-53b2-4813-8289-640c71454bc6 63629-4338 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63629-4346_ce9d25db-abc3-4f94-b82f-c7f63696d95b 63629-4346 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078225 Bryant Ranch Prepack TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 63629-4353_9a4567b7-65d9-4017-9075-4378e4b8de4c 63629-4353 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63629-4355_0b425b27-9d85-46a9-807b-a8eaba4bb58e 63629-4355 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040084 Bryant Ranch Prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 660; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63629-4358_5ed01057-651b-45fd-bbaa-6d1304afb03b 63629-4358 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Bryant Ranch Prepack OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 63629-4367_2c220e74-6f87-4837-91c8-1d16cffe6838 63629-4367 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET, FILM COATED ORAL 20100225 ANDA ANDA075504 Bryant Ranch Prepack QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-4368_0b57f60d-9de1-452c-bdd4-ce1de30a625c 63629-4368 HUMAN PRESCRIPTION DRUG ARMOUR THYROID THYROID TABLET ORAL 20101019 UNAPPROVED DRUG OTHER Bryant Ranch Prepack THYROID, UNSPECIFIED 60 mg/1 63629-4372_4c9e1f0e-b006-2708-07c7-31d249fbd221 63629-4372 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA021366 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 5 mg/1 63629-4383_b937b4e8-fe67-4786-ae16-1e4ea95ac77b 63629-4383 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Bryant Ranch Prepack LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-4385_4bd5ec5e-1fbc-413e-bf03-66000b3eb778 63629-4385 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120815 ANDA ANDA040876 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 63629-4387_eb400030-0ce6-33a8-6400-42681441c940 63629-4387 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20100415 ANDA ANDA077298 Bryant Ranch Prepack METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-4389_ed11aa99-fefc-4ad1-9d66-d048a52af83a 63629-4389 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 Bryant Ranch Prepack CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 63629-4390_d454c75f-0e59-a40f-9ad9-d7fab0da0390 63629-4390 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20081223 ANDA ANDA072750 Bryant Ranch Prepack METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 63629-4394_019fe214-70a0-4f7e-b406-c7e7fa3009c2 63629-4394 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 Bryant Ranch Prepack TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 63629-4399_6ac9bbfe-b9dd-463b-9bcb-c024e083d669 63629-4399 HUMAN PRESCRIPTION DRUG Cetirizine HCl and Pseudoephedrine HCl ER Cetirizine HCl and Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080305 ANDA ANDA077991 Bryant Ranch Prepack CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 63629-4407_1ad8e5c7-15b2-48b1-b846-41de1fa4eb21 63629-4407 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040778 Bryant Ranch Prepack ACETAMINOPHEN; OXYCODONE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4413_9116209f-df47-45cd-9147-acd2e3eb0b5d 63629-4413 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20110307 ANDA ANDA070929 Bryant Ranch Prepack TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 63629-4417_38129a3d-8de8-4028-91bf-8e69fa98df46 63629-4417 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Bryant Ranch Prepack WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 63629-4422_07f2530c-f4fe-4aa0-b83a-43bac57c733c 63629-4422 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Bryant Ranch Prepack METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63629-4436_1bf47e4a-baa6-422f-a185-4357d8a33e80 63629-4436 HUMAN OTC DRUG Fiber Lax Calcium Polycarbophil TABLET, FILM COATED ORAL 20100901 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack CALCIUM POLYCARBOPHIL 625 mg/1 63629-4442_e21600d3-02ef-47a0-a4ca-e25ed5d90c10 63629-4442 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Bryant Ranch Prepack DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-4448_5ec79934-0304-4e3d-a0ef-f12cb0b72c6b 63629-4448 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20051018 ANDA ANDA065144 Bryant Ranch Prepack CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 63629-4458_ece7ce7e-faf0-49e0-8129-66be287e5437 63629-4458 HUMAN OTC DRUG MUCOSA DM GUAIFENESIN DEXTROMETHORPHAN TABLET ORAL 20120417 OTC MONOGRAPH FINAL part341 Bryant Ranch Prepack DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 63629-4462_b535ca3d-35f8-4c91-9622-44dc0e2a864f 63629-4462 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914 NDA NDA020838 Bryant Ranch Prepack CANDESARTAN CILEXETIL 4 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-4468_a7f04d2e-20a1-1cde-efc0-09060445a05b 63629-4468 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA077135 Bryant Ranch Prepack VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63629-4470_56bd7d06-bc6c-44e2-bd90-d55d482460e0 63629-4470 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20061002 ANDA ANDA077912 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-4475_ffbae910-272e-42a8-9703-2c3768146699 63629-4475 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20090127 ANDA ANDA079234 Bryant Ranch Prepack TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63629-4483_c82883f1-36af-4b46-ae8f-e951b96fb09a 63629-4483 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Bryant Ranch Prepack MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4484_edaeca7a-0599-44dc-9c2a-217fe2841eac 63629-4484 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Bryant Ranch Prepack MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4492_dbaf874d-fe74-4767-ae83-56140a9d9630 63629-4492 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET ORAL 20110225 ANDA ANDA090385 Bryant Ranch Prepack LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 63629-4501_a4e8deb5-acd8-4c30-beab-12360200bca3 63629-4501 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 63629-4504_ef76e339-5162-4b9c-b1e2-246d6f3b46f0 63629-4504 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Bryant Ranch Prepack RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 63629-4505_be0fe24f-621c-4187-823f-bcb587c2ef73 63629-4505 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Bryant Ranch Prepack RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 63629-4506_70ccdcfb-014a-4e27-a148-30fb72c77a43 63629-4506 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Bryant Ranch Prepack RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 63629-4514_88ddfc7a-46c4-4171-b74c-f7f0b83e314a 63629-4514 HUMAN PRESCRIPTION DRUG morphine sulfate extended release morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074769 Bryant Ranch Prepack MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4515_736872b0-855f-48c9-a5eb-dddc30eb32b3 63629-4515 HUMAN PRESCRIPTION DRUG morphine sulfate extended release morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Bryant Ranch Prepack MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4519_4b2ba734-d705-44a2-add7-afe6e344248d 63629-4519 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090790 Bryant Ranch Prepack LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-4521_ae724b62-f78f-476a-a7ef-b7f7b3200b12 63629-4521 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride hydromorphone hydrochloride TABLET ORAL 20090729 ANDA ANDA074597 Bryant Ranch Prepack HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4525_113cd947-7748-44f6-8844-d846e4a7b983 63629-4525 HUMAN PRESCRIPTION DRUG Terazosin hydrochloride Terazosin hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Bryant Ranch Prepack TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 63629-4526_0522c550-6f5a-4d9b-b8c9-c8ded7b2beb7 63629-4526 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Bryant Ranch Prepack LEVOFLOXACIN 500 mg/1 63629-4532_8cbdaadc-dcfe-4a91-a2dd-e13b5d82b88a 63629-4532 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA090074 Bryant Ranch Prepack PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 63629-4534_c62ff272-0d25-465f-86ae-a53dbbe7d7e0 63629-4534 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-4543_e00b1c55-cbef-47db-a863-c4fa4e3b8066 63629-4543 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Bryant Ranch Prepack WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 63629-4546_faedb976-f372-431e-affa-93748bdd9ff2 63629-4546 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20020301 UNAPPROVED DRUG OTHER Bryant Ranch Prepack PHENOBARBITAL 16.2 mg/1 CIV 63629-4549_5b17052a-356f-46d8-9580-d360f038a7c7 63629-4549 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 19981217 ANDA ANDA040191 Bryant Ranch Prepack MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4556_da87b550-29cf-4dd1-8301-39d1c8284602 63629-4556 HUMAN PRESCRIPTION DRUG NP Thyroid 30 LEVOTHYROXINE, LIOTHYRONINE TABLET TOPICAL 20101111 UNAPPROVED DRUG OTHER Bryant Ranch Prepack LEVOTHYROXINE; LIOTHYRONINE 19; 4.5 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 63629-4561_6f69826a-be8c-4ce3-88f3-976c1a9e2f83 63629-4561 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20020104 ANDA ANDA040377 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 63629-4562_5409983e-04e0-4329-9399-e1ea8021e885 63629-4562 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030314 ANDA ANDA084283 Bryant Ranch Prepack PREDNISONE 50 mg/1 63629-4565_ce8e1df2-f8e1-44c4-868f-3dfd7f7b1176 63629-4565 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060317 ANDA ANDA077634 Bryant Ranch Prepack ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-4571_59828580-db0c-4973-ad49-0a3e5ff9a658 63629-4571 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 Bryant Ranch Prepack FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4578_cf3ba59a-bfed-41fc-a568-9a4b0a59b572 63629-4578 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Bryant Ranch Prepack PREGABALIN 25 mg/1 CV 63629-4582_4d9e5c39-a657-42b1-a027-afdda984d53f 63629-4582 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19960222 ANDA ANDA040144 Bryant Ranch Prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63629-4588_88054972-5e46-4a71-8065-293f2fae7112 63629-4588 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Bryant Ranch Prepack PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-4593_e3d34142-b46e-42a4-af72-851cbe356216 63629-4593 HUMAN PRESCRIPTION DRUG FAMOTIDINE Famotidine TABLET ORAL 20100218 ANDA ANDA075512 Bryant Ranch Prepack FAMOTIDINE 10 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63629-4597_4af584dd-4c5c-40f1-aefb-14d6eeef603d 63629-4597 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090107 Bryant Ranch Prepack ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 63629-4601_8a6902a9-c846-4d32-8108-200a302da320 63629-4601 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Bryant Ranch Prepack TADALAFIL 5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 63629-4605_ee2e657f-fd08-4803-bbb1-da32a02c8848 63629-4605 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20040115 ANDA ANDA076670 Bryant Ranch Prepack METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-4606_f5b4fe87-d84b-4585-9662-eb1409042899 63629-4606 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20121226 ANDA ANDA077290 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4610_aad51968-d672-4ea6-bc42-bdbbe8319e3c 63629-4610 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-4611_6ed367a5-e725-4a37-b8f1-45f352468ee9 63629-4611 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20090601 NDA NDA022304 Bryant Ranch Prepack TAPENTADOL HYDROCHLORIDE 100 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 63629-4620_2a65d400-cf9c-46df-b42c-9ba9e96b44cc 63629-4620 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Bryant Ranch Prepack OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 63629-4638_3df56c18-ae14-4142-a42f-3c11ad79a333 63629-4638 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 Bryant Ranch Prepack FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 63629-4639_3166a5bc-cade-4e19-9e0f-2c2c6655c00b 63629-4639 HUMAN PRESCRIPTION DRUG SUPRAX CEFIXIME TABLET ORAL 20080401 ANDA ANDA065130 Bryant Ranch Prepack CEFIXIME 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 63629-4641_c144741b-0d0e-497d-9538-0f1f702f8932 63629-4641 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 63629-4642_50347a48-e7de-41e4-8693-fb3faf0395df 63629-4642 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Bryant Ranch Prepack LEVOFLOXACIN 750 mg/1 63629-4644_218be262-d561-4fd7-b7fc-54142b96f536 63629-4644 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20050517 ANDA ANDA077024 Bryant Ranch Prepack CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 63629-4658_101787c4-6722-4a8e-8c0d-7bbb1cca7252 63629-4658 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20041221 ANDA ANDA040584 Bryant Ranch Prepack PREDNISONE 1 mg/1 63629-4663_9dfc687b-d673-48a1-be1c-bf47657cbcfc 63629-4663 HUMAN PRESCRIPTION DRUG Good Sense Acid Reducer Ranitidine TABLET ORAL 20090521 ANDA ANDA076760 Bryant Ranch Prepack RANITIDINE HYDROCHLORIDE 75 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63629-4664_5268b5ff-4092-4806-9957-5031002a8fba 63629-4664 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20110829 ANDA ANDA078722 Bryant Ranch Prepack CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63629-4667_bfd2efc3-fc36-4867-854b-b2aadf9dc0b8 63629-4667 HUMAN PRESCRIPTION DRUG morphine sulfate extended release morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074769 Bryant Ranch Prepack MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4669_da904f80-2863-4bb8-a68e-19afea1b0b0c 63629-4669 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19900930 ANDA ANDA083116 Bryant Ranch Prepack CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-4675_cf5ec5bc-5746-4a87-bd0e-00a8391a1180 63629-4675 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Bryant Ranch Prepack LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-4676_0cd53f16-0a6a-417e-9163-a0841a2bafc5 63629-4676 HUMAN PRESCRIPTION DRUG fluvoxamine maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20001129 ANDA ANDA075888 Bryant Ranch Prepack FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-4685_7248e270-d34d-4e77-a23c-bd802cd4b4cd 63629-4685 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110222 NDA AUTHORIZED GENERIC NDA018279 Bryant Ranch Prepack POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 63629-4688_01f48196-a7ce-4121-bbae-ab16f48eae67 63629-4688 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Bryant Ranch Prepack ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-4689_b235d268-ea31-4132-a4c5-b4ddfc6c2694 63629-4689 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20100511 ANDA ANDA079098 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-4694_d99f379d-a686-4a50-9dca-18de3b26f25c 63629-4694 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Bryant Ranch Prepack MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4695_888e7421-b947-4455-990e-93a213bdfaf9 63629-4695 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Bryant Ranch Prepack MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4697_ca63dfe6-ec06-4ef9-8626-65f381681fd0 63629-4697 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 Bryant Ranch Prepack LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 63629-4698_494545aa-5129-4a51-b1fd-57b31953cfbc 63629-4698 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM ER DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA078705 Bryant Ranch Prepack DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 63629-4699_5dbbac44-b8f8-4699-a0d7-97d09c406932 63629-4699 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Bryant Ranch Prepack ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-4704_2ae3c729-8d9e-4ad8-92c2-950e27ca19d3 63629-4704 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Bryant Ranch Prepack PREGABALIN 200 mg/1 CIV 63629-4707_b7f4d877-a1ad-4070-bfef-93081063b08f 63629-4707 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19871101 ANDA ANDA087499 Bryant Ranch Prepack CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 63629-4708_5cd37caa-f075-45ad-8707-5675cbd33d70 63629-4708 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090107 Bryant Ranch Prepack ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 63629-4717_1e321783-8eed-4bb3-9e3a-ec8af510a778 63629-4717 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19971010 ANDA ANDA073568 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63629-4719_ec395446-2ce2-48aa-ac6b-1368b5f81e04 63629-4719 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Bryant Ranch Prepack SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 63629-4720_29d84e44-4b1d-4611-b609-8dd5c4254281 63629-4720 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Bryant Ranch Prepack SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 63629-4725_847dd1d0-2f9f-4516-9360-abf62c2960dd 63629-4725 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-4728_d55b7eb2-cd71-4c14-8b35-cbc1aa5d5d43 63629-4728 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA076999 Bryant Ranch Prepack CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 63629-4730_831807d9-f5ef-4b8d-9b68-d8978f813021 63629-4730 HUMAN PRESCRIPTION DRUG Ludent Sodium Fluoride TABLET, CHEWABLE ORAL 20111220 UNAPPROVED DRUG OTHER Bryant Ranch Prepack SODIUM FLUORIDE 1 mg/1 63629-4731_9d6aeacf-9d02-49c3-b33d-78c8b1062ee4 63629-4731 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen HYDROCODONE BITARTRATE, ACETAMINOPHEN TABLET ORAL 20120517 ANDA ANDA040846 Bryant Ranch Prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63629-4745_9805be6e-2ee4-41ef-bcc8-51103522daa6 63629-4745 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Bryant Ranch Prepack QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 63629-4748_21914d2b-22e8-4a3f-9cdd-fc4389654479 63629-4748 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 ANDA ANDA040145 Bryant Ranch Prepack WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 63629-4761_97cedfce-f32d-41c5-aa8e-293334c2e95f 63629-4761 HUMAN PRESCRIPTION DRUG LIDODERM lidocaine PATCH CUTANEOUS 19990320 NDA NDA020612 Bryant Ranch Prepack LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63629-4762_163b0760-24ec-4bf4-8a09-2cada3daa85f 63629-4762 HUMAN PRESCRIPTION DRUG Flector Diclofenac Epolamine PATCH TOPICAL 20080114 NDA NDA021234 Bryant Ranch Prepack DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-4764_3221a78a-8312-4ba7-b6af-1fd47b42910d 63629-4764 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Bryant Ranch Prepack FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4765_ec1b9b12-fcba-4c22-bd88-c56b93419564 63629-4765 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20041001 NDA NDA019813 Bryant Ranch Prepack FENTANYL 12.5 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4768_778df04c-722f-448d-957c-afe68b3f31f3 63629-4768 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 Bryant Ranch Prepack FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4771_34e261ca-6a09-4944-9344-316831a8953e 63629-4771 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Bryant Ranch Prepack FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4773_e4b3a428-7c83-4cee-aaa9-ebef684ad0e3 63629-4773 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Bryant Ranch Prepack FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4776_d46b01dc-daa4-45c5-989c-08885041a068 63629-4776 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Bryant Ranch Prepack QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 63629-4778_d6595121-7d0f-44fa-a268-090db206e593 63629-4778 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040526 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 63629-4788_5cc1449f-0e28-4ccb-8490-f76f2f996220 63629-4788 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Bryant Ranch Prepack ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 63629-4790_db18e5df-c35f-4fca-a68c-c4dc5012513f 63629-4790 HUMAN PRESCRIPTION DRUG Loratadine D Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120119 ANDA ANDA076050 Bryant Ranch Prepack LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 63629-4792_e315a2e3-3a25-4b2b-8791-c373aaf308d6 63629-4792 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20070308 ANDA ANDA073671 Bryant Ranch Prepack NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 63629-4796_ad5de759-72d3-4078-b9ef-4f7e8bcbcfe5 63629-4796 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Bryant Ranch Prepack ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-4798_3bbcd9b2-83de-4367-b0ce-267ba122af24 63629-4798 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 63629-4801_9be9e74a-3d33-4a65-b769-6797cb2743e6 63629-4801 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Bryant Ranch Prepack ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-4805_81996542-6d21-4eb9-8ea6-ece2238f8ea5 63629-4805 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-4810_16a9426a-de23-4c4b-8af9-0f27ec6cc358 63629-4810 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20051229 ANDA ANDA076706 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 63629-4813_cda17359-9559-49a5-9c75-2394138aa6f4 63629-4813 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 Bryant Ranch Prepack FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4815_e52c5a1a-b471-4bda-8c36-7b97c7a5c5d2 63629-4815 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Bryant Ranch Prepack ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] 63629-4816_33b4f5b2-d4ed-484b-a190-0b148c71a7ef 63629-4816 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20110815 ANDA ANDA076470 Bryant Ranch Prepack DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 63629-4837_e9e48d50-5447-4380-b89f-51f040369a4a 63629-4837 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20070131 ANDA ANDA076588 Bryant Ranch Prepack VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63629-4838_665b48ac-0702-4fbd-b97a-0d6f0867ac17 63629-4838 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL; SUBLINGUAL 20090921 UNAPPROVED DRUG OTHER Bryant Ranch Prepack HYOSCYAMINE SULFATE .125 mg/1 63629-4841_52deeea0-1166-473b-914d-3c3c3240d71e 63629-4841 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Bryant Ranch Prepack QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 63629-4843_8e39007a-0a22-4a09-a4f5-fdacf380c08a 63629-4843 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET ORAL 20110620 ANDA ANDA090722 Bryant Ranch Prepack LEVOFLOXACIN 250 mg/1 63629-4849_a3c8dc3a-6fc3-4115-a00e-139ec72c1b34 63629-4849 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-4850_7a4a6069-b246-482c-b8e0-77e1322dbec5 63629-4850 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Bryant Ranch Prepack ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-4851_97b7c546-47c6-4583-80c5-a6c1f894a4dd 63629-4851 HUMAN PRESCRIPTION DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120807 ANDA ANDA202319 Bryant Ranch Prepack LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 63629-4855_3489a7de-e6b4-4c7c-8837-958d692a29bb 63629-4855 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA201508 Bryant Ranch Prepack MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 63629-4862_8ca35636-2c78-4323-8bbc-f7b2bc6b8ae5 63629-4862 HUMAN PRESCRIPTION DRUG Chloroquine Phosphate Chloroquine Phosphate TABLET, FILM COATED ORAL 20110315 ANDA ANDA090249 Bryant Ranch Prepack CHLOROQUINE PHOSPHATE 500 mg/1 Antimalarial [EPC] 63629-4865_103ce949-9c0d-4903-a3e1-8c2d27e40039 63629-4865 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Bryant Ranch Prepack ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63629-4872_4fd24d23-258b-4052-998d-fc3c34596d79 63629-4872 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20120515 ANDA ANDA202418 Bryant Ranch Prepack LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 63629-4878_cbf5a392-47e6-4f39-90fc-6ae62a277071 63629-4878 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20110103 ANDA ANDA078381 Bryant Ranch Prepack AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63629-4886_2e051de5-4e18-4015-a722-726ebeb79e00 63629-4886 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET, FILM COATED ORAL 20120803 ANDA ANDA200889 Bryant Ranch Prepack MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 63629-4888_ff84343a-0895-453c-be4c-e95b4af40b82 63629-4888 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20100406 ANDA ANDA090528 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-4899_4ce17f62-f0f3-4bb9-817a-9f41458730f9 63629-4899 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 Bryant Ranch Prepack TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 63629-4900_06d0b6eb-7b27-4acb-b6ba-913c97b4ce71 63629-4900 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 Bryant Ranch Prepack TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 63629-4901_18783b2e-a45f-4c40-9afd-82cc0eafd151 63629-4901 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Bryant Ranch Prepack ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 63629-4914_1f6c4fa3-41dd-4eee-bd89-50c108a5935e 63629-4914 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Bryant Ranch Prepack CETIRIZINE HYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 63629-4929_60a73b69-8792-4088-ba85-ffe321f27777 63629-4929 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Bryant Ranch Prepack HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 63629-4931_0e7aabbb-a1d1-4325-b1d0-e56cb6932dd6 63629-4931 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 Bryant Ranch Prepack FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4937_132e43e2-f8e0-471c-81fe-e8c0c65541f4 63629-4937 HUMAN PRESCRIPTION DRUG Methenamine Mandelate Methenamine Mandelate TABLET, FILM COATED ORAL 20100201 UNAPPROVED DRUG OTHER Bryant Ranch Prepack METHENAMINE MANDELATE 1000 mg/1 63629-4939_f6e78ece-881b-45e8-b538-3f4fb21216ca 63629-4939 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Bryant Ranch Prepack QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 63629-4941_5b140294-6b32-4f55-a89b-76a57b902897 63629-4941 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20071017 NDA NDA022122 Bryant Ranch Prepack DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-4947_fac85e50-b094-4604-8216-19c7099f66f0 63629-4947 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Bryant Ranch Prepack TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-4964_de0a1b1d-fffe-462b-96a6-b2f9c77af0dc 63629-4964 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Bryant Ranch Prepack QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 63629-4965_ac383941-538e-42ad-bd20-c8a99efb4668 63629-4965 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 19900403 ANDA ANDA071891 Bryant Ranch Prepack SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-4968_c01c9ed3-7dad-4a92-8515-218759e21c72 63629-4968 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Bryant Ranch Prepack BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63629-4970_01ce5c48-c16f-48a4-83ca-583a7cd79795 63629-4970 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20121101 ANDA ANDA201089 Bryant Ranch Prepack DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 63629-4971_816eabba-6b66-4eb3-911d-e1f0b0d679e4 63629-4971 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090918 ANDA ANDA090429 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 63629-4974_b6d4dbdb-d2f6-4055-9d08-df2bf8c4a6c5 63629-4974 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Bryant Ranch Prepack FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4975_e9f7809f-a427-436b-8926-d74789046399 63629-4975 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Bryant Ranch Prepack FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4976_287f6d09-e0e0-46fe-8e1c-90ea93cea8d7 63629-4976 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Bryant Ranch Prepack FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4977_88db5bac-73c7-4b4f-a207-8f895223d778 63629-4977 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090918 ANDA ANDA090429 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 63629-4978_751939ba-deec-4003-aecb-d2eb1975129c 63629-4978 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA202096 Bryant Ranch Prepack MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 63629-4979_9b788b76-ffd9-4058-9d10-c20ed46a4c70 63629-4979 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Bryant Ranch Prepack FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4980_68ef2ba1-96af-42ed-ab58-bc9f924b2ee6 63629-4980 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Bryant Ranch Prepack FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4981_95d3cfe1-a858-4141-89a9-753813ba830b 63629-4981 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Bryant Ranch Prepack FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4982_315d1ac9-608e-44f5-b6a9-7c4443e1ecc9 63629-4982 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Bryant Ranch Prepack FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 63629-4987_59d44795-55b5-44f6-9efc-ce10e12e2f09 63629-4987 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 Bryant Ranch Prepack OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-4994_71cce13d-b6ac-4dd2-8dfa-865e2e0f7d43 63629-4994 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 Bryant Ranch Prepack ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-4995_a6609a57-10ef-464c-9d5f-8e655ea7241c 63629-4995 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Bryant Ranch Prepack PREGABALIN 300 mg/1 CV 63629-4998_6c0eae1d-bd3b-45d6-9707-d765281219e6 63629-4998 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20130403 ANDA ANDA076715 Bryant Ranch Prepack MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CV 63629-5007_a42c2e79-652d-4fce-bfa5-69095e934b25 63629-5007 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071994 Bryant Ranch Prepack PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 63629-5008_5ff7324f-e0aa-44fe-8f3f-016983c4f4f0 63629-5008 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060727 ANDA ANDA077636 Bryant Ranch Prepack ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-5013_200d641c-2c25-46ac-a1d5-2a24876824f8 63629-5013 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Bryant Ranch Prepack PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 63629-5014_604a8e53-939c-4df7-8a43-069c5d3eca89 63629-5014 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20111117 ANDA ANDA202032 Bryant Ranch Prepack LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 63629-5027_fee6e4f8-c6e8-43c6-8598-1abdcac98d54 63629-5027 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20060604 ANDA ANDA071588 Bryant Ranch Prepack DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 63629-5028_dca257de-c092-4652-980b-3c967e54d8a2 63629-5028 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20101221 ANDA ANDA090443 Bryant Ranch Prepack IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 63629-5029_a7446e01-f478-4435-8e76-dc57f5ff596d 63629-5029 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET ORAL 20121108 ANDA ANDA202025 Bryant Ranch Prepack SILDENAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 63629-5032_b7bb0a8f-2deb-4e38-b3e4-eeca9e7c6966 63629-5032 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20101004 ANDA ANDA078385 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-5033_7804a9a7-5ca6-4a8a-8353-d7326ec26166 63629-5033 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20121018 ANDA ANDA070791 Bryant Ranch Prepack DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 63629-5034_0b5bd4fc-c750-4f85-afc3-a2a1e585575c 63629-5034 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20100710 ANDA ANDA078920 Bryant Ranch Prepack PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 63629-5036_06e4b102-8e5d-4bd1-900e-be5e1d6ecd21 63629-5036 HUMAN PRESCRIPTION DRUG good neighbor pharmacy pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081103 ANDA ANDA075077 Bryant Ranch Prepack ACETAMINOPHEN 650 mg/1 63629-5038_0c5ad3e8-a196-457f-8ca8-063d33cf1261 63629-5038 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Bryant Ranch Prepack LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-5042_b6b7ed32-6c5d-47e2-ae72-80ed3b7d6956 63629-5042 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Bryant Ranch Prepack PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 63629-5052_5c6f96b3-e215-439e-929c-018e98cf5517 63629-5052 HUMAN PRESCRIPTION DRUG Gralise gabapentin TABLET, FILM COATED ORAL 20110128 NDA NDA022544 Bryant Ranch Prepack GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63629-5058_c641b6a5-ba8e-43e1-b689-0bf711888417 63629-5058 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 19981002 NDA NDA020998 Bryant Ranch Prepack CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-5065_64926d3d-60a5-405e-a703-c7d250cff8fe 63629-5065 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073556 Bryant Ranch Prepack NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 63629-5073_afecd5ca-20fc-45b9-ab29-98aeaffaf572 63629-5073 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077535 Bryant Ranch Prepack ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63629-5074_ee6160a7-3fd1-4280-8d37-63a59cbf7227 63629-5074 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20130222 ANDA ANDA203136 Bryant Ranch Prepack BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 63629-5075_8ff5c83c-d0fa-45c4-8ef9-04566348d272 63629-5075 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20100719 ANDA ANDA091359 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 63629-5078_f5ecf57a-6503-4e00-bd03-e1e856d81b72 63629-5078 HUMAN PRESCRIPTION DRUG Quazepam QUAZEPAM TABLET ORAL 20130808 NDA NDA018708 Bryant Ranch Prepack QUAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-5083_88bb02b6-1686-4172-a290-31be18ee800e 63629-5083 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077535 Bryant Ranch Prepack ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 63629-5085_e772a631-38e7-432b-b923-743fad17bdfe 63629-5085 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20051208 ANDA ANDA077376 Bryant Ranch Prepack MIRTAZAPINE 15 mg/1 63629-5086_960fffd8-2c3f-4fd6-9952-d9f53bafdc26 63629-5086 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20051208 ANDA ANDA077376 Bryant Ranch Prepack MIRTAZAPINE 30 mg/1 63629-5094_d8bb96ca-6c85-42aa-8138-6cc4a1606383 63629-5094 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine PATCH CUTANEOUS 20130915 ANDA ANDA200675 Bryant Ranch Prepack LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63629-5096_5632e9f2-c979-4468-893d-7c053e5f52d5 63629-5096 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960308 NDA AUTHORIZED GENERIC NDA020254 Bryant Ranch Prepack DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-5112_1e26ba9d-d8e5-4a0d-b517-36e3a658973e 63629-5112 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20041123 ANDA ANDA077021 Bryant Ranch Prepack CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 63629-5117_7e6cccb9-9485-4039-91a0-d08599f0b664 63629-5117 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130 ANDA ANDA078554 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-5131_7ccd0529-61b0-4352-b858-434f74273042 63629-5131 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 19860825 ANDA ANDA071017 Bryant Ranch Prepack SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 63629-5132_9bbf3d07-4545-47e6-a635-380538d9c833 63629-5132 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Bryant Ranch Prepack IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-5138_6e250b14-c23a-4744-ac03-00b887c4149a 63629-5138 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20081229 ANDA ANDA040821 Bryant Ranch Prepack GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 63629-5139_208244a8-76c8-495c-b546-a54f0bf5bfe0 63629-5139 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 NDA NDA021447 Bryant Ranch Prepack TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 63629-5147_a5f8251a-7351-49a3-b872-3f8acff999ca 63629-5147 HUMAN PRESCRIPTION DRUG PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100913 NDA NDA020936 Bryant Ranch Prepack PAROXETINE HYDROCHLORIDE HEMIHYDRATE 37.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-5173_64140332-e486-4317-94af-5c08821ecfd0 63629-5173 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol fumarate TABLET ORAL 20090921 ANDA ANDA078635 Bryant Ranch Prepack BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-5174_4c389c0d-497c-4286-8e55-86155f9edcae 63629-5174 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090745 Bryant Ranch Prepack DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-5191_5f9e6e07-cdc7-4e6d-b3cf-f908cbd192d4 63629-5191 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20110114 ANDA ANDA090415 Bryant Ranch Prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63629-5198_5bbe5da7-9491-468a-9ca5-45a80f54b52b 63629-5198 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19900930 ANDA ANDA089763 Bryant Ranch Prepack THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 63629-5202_5d2b82ea-1e64-49e2-92ac-91c3dff3de94 63629-5202 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090745 Bryant Ranch Prepack DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-5208_87fb3a8f-4739-4790-b417-a476a45dd70a 63629-5208 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Bryant Ranch Prepack ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 63629-5216_3c94e42a-9efd-48dc-9410-d8f0864a76e7 63629-5216 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 20070102 ANDA ANDA074722 Bryant Ranch Prepack INDAPAMIDE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 63629-5219_6720ac23-fdba-41d5-984d-46c6867c10ae 63629-5219 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA090425 Bryant Ranch Prepack DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 63629-5220_3d98793e-79cc-41e4-aebd-584c1a531457 63629-5220 HUMAN PRESCRIPTION DRUG FINASTERIDE FINASTERIDE TABLET, FILM COATED ORAL 20131105 ANDA ANDA078371 Bryant Ranch Prepack FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 63629-5223_fd2828a9-18ce-4ef5-8850-9ee05da2424f 63629-5223 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Bryant Ranch Prepack PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 63629-5233_ca10361b-6231-4ab2-b1db-60c794595faf 63629-5233 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil and Hydrochlorothiazide Candesartan Cilexetil and Hydrochlorothiazide TABLET ORAL 20121204 ANDA ANDA202884 Bryant Ranch Prepack CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 16; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-5237_f63247e2-1c06-437a-af07-f42d2161287a 63629-5237 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041221 ANDA ANDA075317 Bryant Ranch Prepack TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 63629-5241_f8805d9a-8e0d-490a-8a98-ebd30e12ec30 63629-5241 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA202254 Bryant Ranch Prepack IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-5246_5d832cb0-e5ca-44a8-a5f3-1928155b1223 63629-5246 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 Bryant Ranch Prepack HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 63629-5247_1cbc1de1-d695-47b9-b756-c14972f44c96 63629-5247 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Bryant Ranch Prepack LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-5250_5c7d4ee3-ffb1-403c-8069-d911b0157c68 63629-5250 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20041221 ANDA ANDA040581 Bryant Ranch Prepack PREDNISONE 2.5 mg/1 63629-5256_ee2fb59d-9785-4b17-82bc-fc1c167d642f 63629-5256 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060401 ANDA ANDA076467 Bryant Ranch Prepack GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 63629-5257_13b58f7b-fe92-4044-9e39-744cb61ba192 63629-5257 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Bryant Ranch Prepack WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 63629-5259_2b177369-c3e9-4b04-814a-25d7403d49fb 63629-5259 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 19810226 ANDA ANDA086831 Bryant Ranch Prepack CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 63629-5268_ae8e4f5e-f458-48c7-8003-4cf2b5d7d3f0 63629-5268 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Bryant Ranch Prepack LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-5269_f7074834-ce60-4ae5-b368-0c338b5cbb54 63629-5269 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100628 ANDA ANDA090568 Bryant Ranch Prepack ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 63629-5270_f1d032ff-f7fd-4cdb-a15c-8acf645fcdcd 63629-5270 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET ORAL 20120701 ANDA ANDA078355 Bryant Ranch Prepack DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 63629-5271_5488d06a-85bb-49b5-80ab-c30a5f6f85cc 63629-5271 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63629-5274_b8a2f035-22a8-4773-8d14-b53625b1b8ae 63629-5274 HUMAN PRESCRIPTION DRUG Piroxicam piroxicam CAPSULE ORAL 20100105 ANDA ANDA074116 Bryant Ranch Prepack PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-5275_32e6929d-0e2b-4954-a2e5-b053082964dc 63629-5275 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20060228 ANDA ANDA077376 Bryant Ranch Prepack MIRTAZAPINE 45 mg/1 63629-5279_fa0aaad2-a022-4965-af30-93806e65dc10 63629-5279 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20070917 ANDA ANDA077222 Bryant Ranch Prepack FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63629-5284_e34dfaec-3d5d-4e67-ad4b-052a742d52f8 63629-5284 HUMAN PRESCRIPTION DRUG Ibuprofen and Pseudoephedrine hydrochloride ibuprofen and pseudoephedrine hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Bryant Ranch Prepack IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 63629-5291_82901f0b-9ff7-4faf-abf0-d1739cf7a63f 63629-5291 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20031016 NDA NDA021487 Bryant Ranch Prepack MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 63629-5292_26bd5403-962a-48f7-a8a5-8685305645c0 63629-5292 HUMAN PRESCRIPTION DRUG BRILINTA Ticagrelor TABLET ORAL 20110805 NDA NDA022433 Bryant Ranch Prepack TICAGRELOR 90 mg/1 P2Y12 Platelet Inhibitor [EPC],Phenylalanine Hydroxylase Activators [MoA],Decreased Platelet Aggregation [PE],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 63629-5304_ae6aabf2-9619-4672-a2fb-a83d140efc39 63629-5304 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 19980508 ANDA ANDA074918 Bryant Ranch Prepack NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] 63629-5308_287564bb-db4f-4f55-b931-1287da7ba86c 63629-5308 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20080222 ANDA ANDA077621 Bryant Ranch Prepack AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 63629-5311_ebe9e68c-2923-4a3c-9370-eb9aee7d6d65 63629-5311 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Bryant Ranch Prepack LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63629-5319_bcf91fa1-85fe-4bfe-8d39-c37987bc63b5 63629-5319 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Bryant Ranch Prepack ESZOPICLONE 2 mg/1 CIV 63629-5320_98235152-907e-47ea-b798-1b835ac9a959 63629-5320 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Bryant Ranch Prepack ESZOPICLONE 3 mg/1 CIV 63629-5321_48a34019-790d-4ead-a315-c3d612983fd9 63629-5321 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET ORAL 20090706 ANDA ANDA078917 Bryant Ranch Prepack BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 63629-5325_f19a9ea1-faf6-4b24-bfed-70a78d77febb 63629-5325 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Bryant Ranch Prepack ESZOPICLONE 1 mg/1 CIV 63629-5327_2756b15b-561d-4b19-813b-14f79cbd28e9 63629-5327 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19990610 ANDA ANDA063065 Bryant Ranch Prepack MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 63629-5341_b57aff62-181c-43ca-9e47-46e017684c96 63629-5341 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19860723 ANDA ANDA089424 Bryant Ranch Prepack SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 63629-5349_17c1b04f-8751-4ab6-b144-8440b01b848c 63629-5349 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Bryant Ranch Prepack ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63629-5361_8dc0f6cf-5a59-4efd-aed2-bbd9ae29bc22 63629-5361 HUMAN PRESCRIPTION DRUG Doxycycline Monohydrate Doxycycline CAPSULE ORAL 20050207 NDA AUTHORIZED GENERIC NDA050641 Bryant Ranch Prepack DOXYCYCLINE 100 mg/1 63629-5364_a1d48fb0-adee-4f00-9ba1-64ae3765b34d 63629-5364 HUMAN PRESCRIPTION DRUG Alprazolam Extended Release Alprazolam TABLET, EXTENDED RELEASE ORAL 20070213 ANDA ANDA078056 Bryant Ranch Prepack ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63629-5366_006af2f4-012f-433e-aead-4710a8a5ec95 63629-5366 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110720 ANDA ANDA077179 Bryant Ranch Prepack AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 63629-5373_f20203b0-8d34-4662-8200-c8ae0abddb10 63629-5373 HUMAN PRESCRIPTION DRUG Chloroquine phosphate Chloroquine phosphate TABLET, FILM COATED ORAL 20110315 ANDA ANDA090610 Bryant Ranch Prepack CHLOROQUINE PHOSPHATE 250 mg/1 Antimalarial [EPC] 63629-5388_f2e1b5fc-db48-4fa5-a933-9c12548c898d 63629-5388 HUMAN PRESCRIPTION DRUG Fenoprofen fenoprofen CAPSULE ORAL 20140714 NDA NDA017604 Bryant Ranch Prepack FENOPROFEN CALCIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63629-5409_bc159274-b336-4a20-8c23-bd0e4d18a717 63629-5409 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Bryant Ranch Prepack FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 63629-5415_40e69310-9837-4c09-baec-fc67256d3d88 63629-5415 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 Bryant Ranch Prepack HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 63629-5418_bf755b96-958b-4a08-98e5-c46cb85cf804 63629-5418 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20111128 ANDA ANDA202170 Bryant Ranch Prepack FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63629-5422_51d5c095-bb06-428b-8ad0-1dc2ca6d04f6 63629-5422 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 Bryant Ranch Prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 63629-5424_094b1a7f-2181-4a92-b539-ebfb02eafe0f 63629-5424 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 Bryant Ranch Prepack HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 63629-5428_c25d8e7a-71f2-4238-a281-501fe2878be4 63629-5428 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen HYDROCODONE BITARTRATE, ACETAMINOPHEN TABLET ORAL 20120517 ANDA ANDA040846 Bryant Ranch Prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 63629-5431_722f9896-5ece-4dd2-845a-ce08ce34846d 63629-5431 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20130510 ANDA ANDA077159 Bryant Ranch Prepack IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63629-5432_735b16f7-b6ab-4243-ba61-adc26c6d8252 63629-5432 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 Bryant Ranch Prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 63629-5434_79cdbbf2-f438-401b-9dc0-159761b1fc63 63629-5434 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040746 Bryant Ranch Prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 63629-5435_832a99c6-d0b5-46cc-b4a9-fe828c343acb 63629-5435 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130104 ANDA ANDA040148 Bryant Ranch Prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 63629-5436_54a70657-2139-41e7-8a4e-6bae79a0d0a0 63629-5436 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040409 Bryant Ranch Prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 63629-5437_f20a0fd2-4d9c-4e31-8833-4ef0ab35af56 63629-5437 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 Bryant Ranch Prepack HYDROCODONE BITARTRATE; IBUPROFEN 2.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 63629-5450_044bcef0-e855-404d-a43e-c7debebf0518 63629-5450 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20110114 ANDA ANDA090415 Bryant Ranch Prepack ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 63645-111_33e3f014-ea35-4b27-b1cc-59fc0cff2caa 63645-111 HUMAN OTC DRUG OraLabs ChapIce Cherry SPF 4 Lip Balm Padimate O, Petrolatum STICK TOPICAL 20000103 OTC MONOGRAPH NOT FINAL part352 OraLabs PADIMATE O; PETROLATUM 15; 440 mg/g; mg/g 63645-128_f0ad0966-6c61-4350-918a-282c10e9c9ef 63645-128 HUMAN OTC DRUG USANA Lip Moisturizer Avobenzone, Octinoxate, Octisalate LIPSTICK TOPICAL 20120706 OTC MONOGRAPH NOT FINAL part352 Oralabs AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/1; g/1; g/1 63645-130_6ae352fa-3d4b-4720-b68b-f58b690a501f 63645-130 HUMAN OTC DRUG ChapIce Original SPF 4 Lip Balm Padimate O, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 OraLabs PADIMATE O; PETROLATUM 1.5; 44 mg/g; mg/g 63645-140_1fcc1d6e-71b8-4f2f-8794-b3d013ad4ea7 63645-140 HUMAN OTC DRUG ChapIce Moisture SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 OraLabs OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 40.7 mg/g; mg/g; mg/g 63645-160_a0f07fe2-63e7-4908-ac4f-7c25d396738b 63645-160 HUMAN OTC DRUG ChapIce Camphor Phenol Gel Camphor, Phenol GEL TOPICAL 20130315 OTC MONOGRAPH FINAL part346 OraLabs CAMPHOR (SYNTHETIC); PHENOL 10.8; 4.7 mg/g; mg/g 63645-161_68b9836e-85f7-4f1f-8312-d15f991c20e6 63645-161 HUMAN OTC DRUG ChapIce Medicated Balm Camphor, Menthol GEL TOPICAL 20130315 OTC MONOGRAPH FINAL part346 OraLabs CAMPHOR (SYNTHETIC); MENTHOL 1.7; .7 mg/g; mg/g 63645-162_792873ae-b15a-408e-92d0-e8bf1e6fc8f1 63645-162 HUMAN OTC DRUG OraLabs Cold Sore Treatment Benzocaine OINTMENT TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part348 OraLabs BENZOCAINE 5 mg/g 63646-191_5c361496-203d-43a4-ad57-a510c9428928 63646-191 HUMAN PRESCRIPTION DRUG ATRIDOX Doxycycline Hyclate KIT ORAL 19980903 NDA NDA050751 TOLMAR Inc. 63653-1171_7a76a774-52ce-4204-bb54-971b02c6003b 63653-1171 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 19000101 NDA NDA020839 Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 63653-1332_7a76a774-52ce-4204-bb54-971b02c6003b 63653-1332 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 19000101 NDA NDA020839 Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 63654-500_132086cf-8509-4e69-b2f7-4a3e1f462a09 63654-500 HUMAN OTC DRUG XL-DOL acetaminophen TABLET ORAL 20111115 OTC MONOGRAPH NOT FINAL part343 Selder, S.A. de C.V. ACETAMINOPHEN 500 mg/1 63654-600_09cc48f3-e043-4da8-a9f1-00cb6ccbee95 63654-600 HUMAN OTC DRUG Cold Medicine XL3 Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride TABLET ORAL 20111115 OTC MONOGRAPH FINAL part341 Selder, S.A. de C.V. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 4; 10 mg/1; mg/1; mg/1 63654-700_48463aac-5d95-43fa-a623-510c40c15d7b 63654-700 HUMAN OTC DRUG Cold Medicine XL-3 for Children Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride TABLET, CHEWABLE ORAL 20111115 OTC MONOGRAPH FINAL part341 Selder, S.A. de C.V. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 80; 2; 5 mg/1; mg/1; mg/1 63654-800_664add4d-d3f8-4c7c-9784-7b08be2b143f 63654-800 HUMAN OTC DRUG Cough and Cold XL3 Xtra Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20111115 OTC MONOGRAPH FINAL part341 Selder, S.A. de C.V. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 250; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 63667-224_de651e96-92b4-4b56-9878-511987e99628 63667-224 HUMAN OTC DRUG DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL LOZENGE ORAL 20110403 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 8.3 mg/1 63667-242_068ff248-257d-45f2-ba72-ccb50e12af23 63667-242 HUMAN OTC DRUG DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL LOZENGE ORAL 20110403 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 8.5 mg/1 63667-503_09c28807-d8da-4028-bdac-198e2471823c 63667-503 HUMAN OTC DRUG EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL LOZENGE ORAL 20130527 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 8.3 mg/1 63667-507_f75e1caa-7606-4f52-bf28-561f2c606010 63667-507 HUMAN OTC DRUG Natural Cherry Honey Herb Throat Drops MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola USA Inc. MENTHOL 1.8 mg/1 63667-676_d9e08bba-c72c-4b1a-a93f-1a25271b18fd 63667-676 HUMAN OTC DRUG NATURAL LEMON MINT HERB THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola USA Inc. MENTHOL 1.6 mg/1 63667-923_c57b88a0-3d0d-4bf2-a950-10e4b31d4cc2 63667-923 HUMAN OTC DRUG THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 5.3 mg/1 63667-941_302948d8-9424-4659-94fb-7baaaaadd25e 63667-941 HUMAN OTC DRUG NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 1.5 mg/1 63667-953_7ff8e65a-a5c7-4526-aab1-55133e8b389b 63667-953 HUMAN OTC DRUG Natural Cherry Honey Herb Throat Drops MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola USA Inc. MENTHOL 2 mg/1 63667-954_25735b21-1aaf-4bcf-a8df-1161d309c182 63667-954 HUMAN OTC DRUG NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 2 mg/1 63667-955_6c7f81c1-f27d-4e3c-a233-c97708ab9c75 63667-955 HUMAN OTC DRUG THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 4.8 mg/1 63667-956_da64fa75-4003-4105-a1a4-bd9c1437e8a4 63667-956 HUMAN OTC DRUG SUGAR FREE LEMON MINT HERB THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola USA Inc. MENTHOL 1.1 mg/1 63667-957_8c3017db-dee3-46ac-a4b2-e5a869401b4c 63667-957 HUMAN OTC DRUG NATURAL LEMON MINT HERB THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola USA Inc. MENTHOL 1.5 mg/1 63667-958_d44636ac-94c5-470e-ac0d-dd8db00c1c1e 63667-958 HUMAN OTC DRUG Sugar Free Mountain Herb Cough Suppressant Throat Drops MENTHOL LOZENGE ORAL 19420412 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 4.8 mg/1 63667-960_44f2a230-7b1d-4a21-82a0-b1bea2e98513 63667-960 HUMAN OTC DRUG Natural Honey Lemon with Echinacea Cough Suppressant Throat Drops MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 3.5 mg/1 63667-962_9a17254a-0ad5-4475-aad4-8473d4392e76 63667-962 HUMAN OTC DRUG Sugar Free Cherry Herb Throat Drops Menthol LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola USA Inc. MENTHOL 2.6 mg/1 63667-966_1b94c985-4016-4985-94df-44abba3907a3 63667-966 HUMAN OTC DRUG Natural Lemon Verbena with White Tea Herb Throat Drops Menthol LOZENGE ORAL 20080801 OTC MONOGRAPH NOT FINAL part356 Ricola USA Inc. MENTHOL 1.2 mg/1 63667-971_c607b455-dac6-4f62-8616-324456c4114e 63667-971 HUMAN OTC DRUG SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 4.1 mg/1 63667-976_4b8c2385-5d90-4310-a1e9-cd180f4d7b81 63667-976 HUMAN OTC DRUG SUGAR FREE SWISS CHERRY HERB THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola USA Inc. MENTHOL 2.2 mg/1 63672-0005_65ee30e3-b0ed-4150-b590-95387ed3a991 63672-0005 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20090706 ANDA ANDA077973 Synthon Pharmaceuticals, Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 63672-0015_5debd92c-9b60-475d-bf8b-b8cae30e43c6 63672-0015 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, FILM COATED ORAL 20100628 ANDA ANDA078322 Synthon Pharmaceuticals, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 63672-0021_e4c3c963-977b-4772-99d5-3b930a4aae41 63672-0021 HUMAN PRESCRIPTION DRUG tamsulosin hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078801 Synthon Pharmaceuticals, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 63672-0051_c1f4c652-5aa3-4f4f-a201-9d540a058557 63672-0051 HUMAN PRESCRIPTION DRUG Levocetirizine dihydrochloride Levocetirizine dihydrochloride TABLET, FILM COATED ORAL 20101126 ANDA ANDA090229 Synthon Pharmaceuticals, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 63687-0001_6e294ef0-e6b9-41ef-ab6b-377113f818fb 63687-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000201 UNAPPROVED MEDICAL GAS EME Medical Equipment (Ephrata Medical Equip.) OXYGEN 99 L/100L 63691-002_ba113747-7e63-40d0-9ba9-7366c296755d 63691-002 HUMAN OTC DRUG Antibacterial Triclosan SOAP TOPICAL 19980213 OTC MONOGRAPH NOT FINAL part333A Sun Products Corporation TRICLOSAN .1 mL/100mL 63691-005_50c6abef-c15f-4cf3-9806-b3e7217f12a3 63691-005 HUMAN OTC DRUG HyVee Ultra Concentrated Citrus Scent Triclosan SOAP TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL 63691-006_29353db0-3ef2-4a34-90fb-c20d0fd67fc3 63691-006 HUMAN OTC DRUG HyVee Ultra Concentrated Green Apple Scent Triclosan SOAP TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL 63691-007_c7cc2701-1a53-4a21-945a-8c2fcbade810 63691-007 HUMAN OTC DRUG Southern Home Supreme Clean Ultra Concentrated Orange Scent Triclosan SOAP TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL 63691-008_ceb22c85-263f-4c38-9c88-52d797ea80b2 63691-008 HUMAN OTC DRUG Our Family Dish and Antibacterial Green Apple Scent Triclosan SOAP TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL 63691-009_a6cce003-e881-4954-9a8c-1f8681b542d9 63691-009 HUMAN OTC DRUG Our Family Dish and Antibacterial Citrus Burst Scent Triclosan SOAP TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL 63691-010_9817d563-9e61-47df-9858-0708392c1f46 63691-010 HUMAN OTC DRUG Safeway Home Orange Scent Triclosan SOAP TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL 63691-011_7cf76aa8-7614-48e3-8734-235b16871338 63691-011 HUMAN OTC DRUG Wegmans Ultra Dishwashing Orange Scent Triclosan SOAP TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL 63691-012_684b29f5-8d38-4911-8b14-f52cdb60a43e 63691-012 HUMAN OTC DRUG Safeway Home Lemon Scent Triclosan SOAP TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL 63691-013_0c8df5d7-7bcb-42b6-80f9-78f0105e62b0 63691-013 HUMAN OTC DRUG Home 360 Ultra Dish Detergent Green Apple Scent Triclosan SOAP TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL 63691-014_4b44f624-844d-4a60-8e21-3aad740726a3 63691-014 HUMAN OTC DRUG Publix UltraDish Detergent Triclosan SOAP TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL 63691-015_2f307265-693d-4b79-ba68-ca897108c4e6 63691-015 HUMAN OTC DRUG Great Value Ultra Concentrated Orange Scent Triclosan SOAP TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL 63691-016_00aa6fa8-9db2-4cac-a4e4-bdede3f7bb8d 63691-016 HUMAN OTC DRUG Publix UltraDish Detergent Green Apple Scent Triclosan SOAP TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL 63691-017_d8dc5d4d-ebd9-4632-8387-3ca9767d3074 63691-017 HUMAN OTC DRUG Great Value Ultra Concentrated Green Apple Scent Triclosan SOAP TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL 63691-018_bdd71752-317d-467e-abe7-652777110487 63691-018 HUMAN OTC DRUG Home Sense Ultra Green Apple Scent Triclosan SOAP TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL 63691-019_3a9d376a-5b4f-40e7-a89b-c7db1d2e2e7f 63691-019 HUMAN OTC DRUG Up (and) Up Green Apple Scent Triclosan SOAP TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL 63691-020_5e4a8678-0ed7-42d9-9b35-46cffefd91b6 63691-020 HUMAN OTC DRUG Reeva Antibacterial Green Apple Triclosan SOAP TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL 63699-001_f7edf9f6-c3ac-4b15-b448-c919f102991b 63699-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20120831 UNAPPROVED MEDICAL GAS Ablecare Medical, Inc. OXYGEN 99 L/100L 63704-004_fcc24d99-0809-4e43-9559-22575ed30424 63704-004 HUMAN PRESCRIPTION DRUG METHYLERGONOVINE MALEATE methylergonovine maleate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101101 ANDA ANDA040889 Pharmacist Pharmaceutical, LLC METHYLERGONOVINE MALEATE .2 mg/mL Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 63704-006_84d562e7-4ac9-43d5-bcd6-af370975c027 63704-006 HUMAN PRESCRIPTION DRUG methylergonovine maleate methylergonovine maleate TABLET ORAL 20110801 ANDA ANDA091577 Pharmacist Pharmaceutical, LLC METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 63704-008_7e01739f-e7de-4a13-8300-e8a5ed8e54a8 63704-008 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20130412 ANDA ANDA091667 Pharmacist Pharmaceutical, LLC MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 63704-009_f9c3c141-3ac1-4e8c-ac2d-e57fac0be7a3 63704-009 HUMAN PRESCRIPTION DRUG Levonorgestrel Levonorgestrel TABLET ORAL 20130611 ANDA ANDA202508 Pharmacist Pharmaceutical, LLC LEVONORGESTREL 1.5 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 63704-010_840a68ff-8ee6-42d1-b371-6310093ec565 63704-010 HUMAN OTC DRUG Levonorgestrel Levonorgestrel TABLET ORAL 20140312 ANDA ANDA202508 Pharmacist Pharmaceutical, LLC LEVONORGESTREL 1.5 mg/1 63712-123_1e162f4e-34d5-4dc4-8a90-e1c402193afe 63712-123 HUMAN OTC DRUG DAILY DEFENCE SUNSCREEN Broad Spectrum SPF30 Octinoxate, Octisalate, Avobenzone, and Octocrylene CREAM TOPICAL 20140602 OTC MONOGRAPH NOT FINAL part352 ZELENS Limited AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 74; 50; 27 mg/mL; mg/mL; mg/mL; mg/mL 63713-461_90260084-da43-4e2c-90c1-37127150a9be 63713-461 HUMAN PRESCRIPTION DRUG thrombin human thrombin human POWDER, FOR SOLUTION TOPICAL 20090919 BLA BLA125247 Ethicon, Inc THROMBIN HUMAN 2000 [iU]/2mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] 63717-276_fb6b0e4f-0edf-48e6-8892-bea8d00da98f 63717-276 HUMAN OTC DRUG Nasotuss Chlorcyclizine Hydrochloride, Codeine Phosphate, Phenylephrine Hydrochloride LIQUID ORAL 20101108 OTC MONOGRAPH FINAL part341 Hawthorn Pharmaceuticals, Inc. CHLORCYCLIZINE HYDROCHLORIDE; CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE 25; 10; 10 mg/5mL; mg/5mL; mg/5mL CV 63717-325_87262124-5687-4987-ba17-1637be453434 63717-325 HUMAN OTC DRUG Nasohist DM Pediatric Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20110609 OTC MONOGRAPH FINAL part341 Hawthorn Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 3; 2 mg/mL; mg/mL; mg/mL 63717-326_ed9e906e-265d-4949-adb8-bfcfb780e212 63717-326 HUMAN OTC DRUG Nasohist Pediatric Chlorpheniramine Maleate, Phenylephrine Hydrochloride LIQUID ORAL 20110608 OTC MONOGRAPH FINAL part341 Hawthorn Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2 mg/mL; mg/mL 63717-331_e4601bbe-1ebb-4600-9d3e-2f1b521e1f8b 63717-331 HUMAN OTC DRUG biclora Chlophedianol Hydrochloride, Chlorcyclizine Hydrochloride LIQUID ORAL 20121031 OTC MONOGRAPH FINAL part341 Hawthorn Pharmaceuticals, Inc CHLOPHEDIANOL HYDROCHLORIDE; CHLORCYCLIZINE HYDROCHLORIDE 12.5; 12.5 mg/5mL; mg/5mL 63717-332_ad167d4b-2231-471c-8d02-079efc51a43f 63717-332 HUMAN OTC DRUG biclora Chlorphedianol Hydrochloride, Chlorcyclizine Hydrochloride TABLET ORAL 20121130 OTC MONOGRAPH FINAL part341 Hawthorn Pharmaceuticals, Inc. CHLOPHEDIANOL HYDROCHLORIDE; CHLORCYCLIZINE HYDROCHLORIDE 25; 25 mg/1; mg/1 63717-333_3e12c43e-2b55-41de-ba92-0c7118e5d6dd 63717-333 HUMAN OTC DRUG biclora-D Chlophedianol Hydrochloride, Chlorcyclizine Hydrochloride, Pseudoephedrine Hydrochloride LIQUID ORAL 20121008 20150131 OTC MONOGRAPH FINAL part341 Hawthorn Pharmaceuticals, Inc CHLOPHEDIANOL HYDROCHLORIDE; CHLORCYCLIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 12.5; 12.5; 30 mg/5mL; mg/5mL; mg/5mL 63717-513_b523eb27-362e-4baa-b35b-324b1f54e0a6 63717-513 HUMAN PRESCRIPTION DRUG Utira-C Hyoscyamine Sulfate 0.12mg, Methenamine 81.6 mg, Phenyl Salicylate 36.2 mg, Sodium Phosphate Monobasic 40.8 mg, Methylene Blue 10.8 mg TABLET, SUGAR COATED ORAL 20050901 UNAPPROVED DRUG OTHER Hawthorn Pharmaceuticals HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .12; 81.6; 10.8; 36.2; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1 63717-870_1ba6c095-5c85-4d28-959c-45a1b5569e4f 63717-870 HUMAN PRESCRIPTION DRUG Arbinoxa Carbinoxamine Maleate TABLET ORAL 20100823 ANDA ANDA090417 Hawthorn Pharmaceuticals, Inc. CARBINOXAMINE MALEATE 4 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 63717-871_f9ebe04a-39e2-4cfe-81d7-a692801dc334 63717-871 HUMAN PRESCRIPTION DRUG Arbinoxa Carbinoxamine maleate SOLUTION ORAL 20110401 ANDA ANDA090418 Hawthorn Pharmaceuticals, Inc. CARBINOXAMINE MALEATE .8 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 63717-875_0bbc5329-a003-4cce-acfb-22dcd3a851d6 63717-875 HUMAN PRESCRIPTION DRUG REZIRA hydrocodone bitartrate, pseudoephedrine hydrochloride SOLUTION ORAL 20110608 NDA NDA022442 Hawthorn Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 60 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] CII 63717-876_7232e7d4-0d28-42f1-a77b-aa88765894c3 63717-876 HUMAN PRESCRIPTION DRUG ZUTRIPRO hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride SOLUTION ORAL 20110608 NDA NDA022439 Hawthorn Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 5; 60 mg/5mL; mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII 63717-877_8756081a-06c6-450f-b7bd-0bede050cc8e 63717-877 HUMAN PRESCRIPTION DRUG Vituz Hydrocodone Bitartrate, and Chlorpheniramine Maleate SOLUTION ORAL 20130401 NDA NDA204307 Hawthorn Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE 4; 5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII 63717-895_bb9f21ce-49bd-454b-89ff-205e9ca10e7c 63717-895 HUMAN PRESCRIPTION DRUG ZAMICET HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20080825 ANDA ANDA040834 Hawthorn Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63717-900_444c745c-a6f4-4fea-b540-dcd51dd8f630 63717-900 HUMAN PRESCRIPTION DRUG Reprexain hydrocodone bitartrate, ibuprofen TABLET, FILM COATED ORAL 20081216 ANDA ANDA076642 Hawthorn Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 2.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 63717-901_0116d4a6-b19b-41ab-92be-dd73f7872e1e 63717-901 HUMAN PRESCRIPTION DRUG Reprexain hydrocodone bitartrate, ibuprofen TABLET, FILM COATED ORAL 20081216 ANDA ANDA076642 Hawthorn Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 63717-902_f66cc17c-a366-4a97-acfe-c50bb3d6b564 63717-902 HUMAN PRESCRIPTION DRUG Reprexain hydrocodone bitartrate, ibuprofen TABLET, FILM COATED ORAL 20081216 ANDA ANDA076642 Hawthorn Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 10; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 63717-910_462792de-0914-47ae-b8d5-ed35b1346031 63717-910 HUMAN PRESCRIPTION DRUG Eliphos Calcium Acetate TABLET ORAL 20090201 ANDA ANDA078502 Hawthorn Pharmaceutical, Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 63717-915_332a4e28-b225-4593-a886-35b626132d33 63717-915 HUMAN PRESCRIPTION DRUG Veripred 20 PREDNISOLONE SODIUM PHOSPHATE SOLUTION ORAL 20091101 ANDA ANDA078988 Hawthorne Pharmaceuticals, Inc. PREDNISOLONE SODIUM PHOSPHATE 20 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63722-001_70952e15-19fd-4ddc-afed-237a9dc99f0f 63722-001 HUMAN OTC DRUG Desmanol Pure isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333E Schulke & Mayr GmbH ALCOHOL 81.11 mL/100mL 63730-113_54da4a56-7ac7-4193-a203-8602d5871bda 63730-113 HUMAN OTC DRUG VITAMIN CREAM C plus C avobenzone, homosalate, octinoxate, octocrylene CREAM TOPICAL 20100419 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 2.25; 7.5; 2.25; 1.88 mL/75mL; mL/75mL; mL/75mL; mL/75mL 63730-171_cd3db22a-7bd2-4a6e-bced-6f11c938634b 63730-171 HUMAN OTC DRUG The Cure Sheer Cream Octinoxate, Titanium Dioxide CREAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International OCTINOXATE; TITANIUM DIOXIDE 2; 4 mL/50mL; g/50mL 63730-204_ed12b13e-5d4a-4fa0-ac98-790347a98ed1 63730-204 HUMAN OTC DRUG Essential Shockeye and Lip Avobenzone, Homosalate, Octinocate, Octocrylene, Oxybenzone CREAM TOPICAL 20100604 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International, S.A. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 454; 1.44; .6; .36; 151 mg/15mL; mL/15mL; mL/15mL; mL/15mL; mg/15mL 63730-206_275c66be-c357-42c4-bdaf-836debc5a4cb 63730-206 HUMAN OTC DRUG Sun Defense Cream Homosalate, Octinoxate, Methoxycinnamate, Octisalate, Titanium Dioxide CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International HOMOSALATE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 2; 6; 4; 9 mL/75mL; mL/75mL; mL/75mL; g/75mL 63730-216_c2504171-ecca-4d8b-aa6a-f9df73bbfb78 63730-216 HUMAN OTC DRUG Tensolift Avobenzone, Homosalate, Octinoxate, Octyocrelene, Oxybenzone CREAM TOPICAL 20100607 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International, S.A. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 2.76; 8.76; 3.65; 2.19; 921 g/90mL; mL/90mL; mL/90mL; mL/90mL; mg/90mL 63730-220_9bbeba58-7c5d-4be0-965b-c49b1db05df2 63730-220 HUMAN OTC DRUG Luminous Shield SPF 50 Ensulizole, Octinoxate, Octocreylene, Oxybensone, Titanium Dioxide CREAM TOPICAL 20100419 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International, S.A. ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 1.65; 4.9; 7.85; 2.47; 10.14 g/75mL; mL/75mL; mL/75mL; g/75mL; g/75mL 63730-221_d1360a91-ca34-4efa-8624-d050c89c61f0 63730-221 HUMAN OTC DRUG Daily Defense SPF 30 Oil Free Fluid Ensulizole, Octinoxate, Titanium Dioxide CREAM TOPICAL 20100419 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International, S.A. ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 5.52; 6.23; 5.29 g/75mL; mL/75mL; g/75mL 63730-222_4afa4533-6921-4974-8b3c-b63533061088 63730-222 HUMAN OTC DRUG The Cure Oil-Free Octinoxate, Titanium Dioxide CREAM TOPICAL 20140421 OTC MONOGRAPH FINAL part352 Natura Bisse International SA OCTINOXATE; TITANIUM DIOXIDE 2; 3 g/50g; g/50g 63730-223_f835b1c3-5873-488a-8b52-58d15ac19be7 63730-223 HUMAN OTC DRUG Diamond White Oil-Free Brilliant Sun Protection Ensulizole, Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International SA ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1; 2; 3; 2 g/30g; g/30g; g/30g; g/30g 63730-224_55eb2538-e602-408e-9979-f2310bf80956 63730-224 HUMAN OTC DRUG Diamond White Matte Finish Sun Protection Ensulizole, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International SA ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 1; 2; 5; 3; 4 g/50g; g/50g; g/50g; g/50g; g/50g 63730-292_df1f2cbe-c7f5-4bd0-bb33-286c7f70c3c7 63730-292 HUMAN OTC DRUG Diamond White Brightening Shield Treatment Cream Ethylhexyl Methoxycinnamate (Octinoxate), Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20130125 OTC MONOGRAPH FINAL part352 Natura Bisse International OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.4; .9; 5.7 mg/30mL; mg/30mL; mg/30mL 63730-304_3055c454-0374-4416-8db6-6c9f7087212a 63730-304 HUMAN OTC DRUG Vitamin Fluid CC AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20100412 OTC MONOGRAPH FINAL part352 Natura Bisse International S.A. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 1.5; 5; 1.5; 1.25 mL/50mL; mL/50mL; mL/50mL; mL/50mL 63736-001_7dff99b6-bf15-475c-94db-331edee20da1 63736-001 HUMAN OTC DRUG Monistat 1 Combination Pack Triple Action Miconazole Nitrate KIT 20010629 NDA NDA021308 Insight Pharmaceuticals 63736-002_d56633cc-333f-423b-b64b-e677e087291f 63736-002 HUMAN OTC DRUG Monistat 3 Combination Pack Triple Action Miconazole Nitrate KIT 19960416 NDA NDA020670 Insight Pharmaceuticals 63736-003_0f0c66d5-e8df-4834-af66-38f7f3a9f5d7 63736-003 HUMAN OTC DRUG Monistat 7 Combination Pack Triple Action Miconazole Nitrate KIT 19930426 NDA NDA017450 Insight Pharmaceuticals 63736-011_de989bac-9bd1-46b5-930f-73f0e79af53c 63736-011 HUMAN OTC DRUG Tanac Benzocaine LIQUID ORAL 20110101 OTC MONOGRAPH FINAL part348 Insight Pharmaceuticals LLC BENZOCAINE 1.3 mg/13mL 63736-012_856ae077-f23b-40bf-9a06-09e6f0d56d19 63736-012 HUMAN OTC DRUG Kondremul Kondremul LIQUID ORAL 20090605 OTC MONOGRAPH FINAL part334 Insight Pharmaceuticals MINERAL OIL 2.5 mL/5mL 63736-013_c4959afc-0e98-4da4-893b-5da6a0b65957 63736-013 HUMAN OTC DRUG Monistat 1 Combination Pack Miconazole Nitrate KIT 20010629 NDA NDA021308 Insight Pharmaceuticals 63736-014_f4d0fb63-ff03-4d5a-9f11-2e04fbb0823b 63736-014 HUMAN OTC DRUG Monistat 1 Combination Pack Miconazole Nitrate KIT 20010629 NDA NDA021308 Insight Pharmaceuticals 63736-015_b9874b2a-5c6e-4b87-a570-19804b7fc99b 63736-015 HUMAN OTC DRUG Monistat 3 3-Day Pre-filled Applicators Miconazole Nitrate CREAM VAGINAL 19980330 NDA NDA020827 Insight Pharmaceuticals MICONAZOLE NITRATE 40 mg/g 63736-016_adba15db-7324-4621-be60-71a8b1f895df 63736-016 HUMAN OTC DRUG Monistat 3 Combination Pack Miconazole Nitrate KIT 19960416 NDA NDA020670 Insight Pharmaceuticals 63736-018_d2d67e80-0b22-4ecd-b721-5d259e90fc3a 63736-018 HUMAN OTC DRUG Monistat 3 Combination Pack Miconazole Nitrate KIT 20091210 NDA NDA020670 Insight Pharmaceuticals 63736-019_3489afb2-0cdf-4fd4-a5b8-4860bd3c9f51 63736-019 HUMAN OTC DRUG Monistat 3 Combination Pack 3 Ovule Inserts Miconazole Nitrate KIT 19960416 NDA NDA020670 Insight Pharmaceuticals 63736-023_eaa9e15b-ff99-4f88-b5ce-e5851676731e 63736-023 HUMAN OTC DRUG Monistat 7 Combination Pack 7-Day Pre-Filled Applicators Miconazole Nitrate KIT 19930426 NDA NDA017450 Insight Pharmaceuticals 63736-024_58c9864e-f28c-4ea3-988f-c2d21c108b47 63736-024 HUMAN OTC DRUG Nix Permethrin SHAMPOO TOPICAL 20090605 NDA NDA019918 Insight Pharmaceuticals PERMETHRIN 560 mg/59mL 63736-024_5d596cc9-d8d0-4cc4-9b9d-cd303330e9b5 63736-024 HUMAN OTC DRUG Nix Permethrin SHAMPOO TOPICAL 20090605 NDA NDA019918 Insight Pharmaceuticals PERMETHRIN 560 mg/59mL 63736-025_86e62d97-42cb-45b9-b634-db0e4a497fa7 63736-025 HUMAN OTC DRUG Monistat 7 with Reusable Applicator Miconazole Nitrate CREAM VAGINAL 19930426 NDA NDA017450 Insight Pharmaceuticals MICONAZOLE NITRATE 20 mg/g 63736-026_f65a4c4d-ec1d-40de-a1f2-1786452fc218 63736-026 HUMAN OTC DRUG Monistat 7 7-Day Disposable Applicators Miconazole Nitrate CREAM VAGINAL 20100415 NDA NDA017450 Insight Pharmaceuticals MICONAZOLE NITRATE 20 mg/g 63736-027_9feae582-d3e2-49e7-b9d5-a56f68dbae50 63736-027 HUMAN OTC DRUG Nix Complete Maximum Strength Lice Elimination Permethrin KIT 20131115 NDA NDA019918 Insight Pharmaceuticals 63736-028_986e9056-8664-4afc-8b65-97fbf96f5841 63736-028 HUMAN OTC DRUG NICE Cool Mint Menthol LOZENGE ORAL 20090605 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals MENTHOL 8 mg/1 63736-029_245c0edc-ed04-4ee9-9f04-cfc03fc36f6a 63736-029 HUMAN OTC DRUG Monistat Complete Care Instant Itch Relief hydrocortisone CREAM TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part348 Insight Pharmaceuticals HYDROCORTISONE 1 g/100g 63736-031_ea1a4a6c-3814-4789-916f-f042d5db8958 63736-031 HUMAN OTC DRUG Monistat Complete Care Chafing Relief dimethicone GEL TOPICAL 20131115 OTC MONOGRAPH FINAL part347 Insight Pharmaceuticals DIMETHICONE 1.2 g/100g 63736-041_3d1bdfc4-e7dc-45eb-b187-d7fde11d2ab4 63736-041 HUMAN OTC DRUG Boil Ease Benzocaine CREAM TOPICAL 20100621 OTC MONOGRAPH NOT FINAL part348 Insight Pharmaceuticals BENZOCAINE 5 g/28g 63736-044_f119f7a7-c1a8-44a6-a678-0e13c46294fd 63736-044 HUMAN OTC DRUG Bonine Kids Chlorcyclizine Hydrochloride TABLET, CHEWABLE ORAL 20090608 OTC MONOGRAPH FINAL part336 Insight Pharmaceuticals CHLORCYCLIZINE HYDROCHLORIDE 25 mg/1 63736-051_ae2068a0-094b-464e-b2b9-924f2aff3cf5 63736-051 HUMAN OTC DRUG Ting Tolnaftate CREAM TOPICAL 20090608 OTC MONOGRAPH FINAL part333 Insight Pharmaceuticals TOLNAFTATE 100 mg/g 63736-072_8cbbb896-d9ee-4213-be57-a3647af4abb9 63736-072 HUMAN OTC DRUG Nostrilla Oxymetazoline Hydrochloride SPRAY, METERED NASAL 20090608 OTC MONOGRAPH FINAL part341 Insight Pharmaceuticals OXYMETAZOLINE HYDROCHLORIDE .0005 mL/100mL 63736-073_163fdf44-0a0d-4af4-9387-7eb78e82873c 63736-073 HUMAN OTC DRUG Dermarest Psoriasis Medicated Moisturizer Salicylic Acid LOTION TOPICAL 20100723 OTC MONOGRAPH FINAL part358H Insight Pharmaceuticals SALICYLIC ACID 2.36 mL/118mL 63736-124_82885c3d-4964-44dd-8bb6-fe55afab3ce7 63736-124 HUMAN OTC DRUG Bonine meclizine hydrochloride TABLET, CHEWABLE ORAL 20090608 OTC MONOGRAPH FINAL part336 Insight Pharmaceuticals MECLIZINE HYDROCHLORIDE 25 mg/1 63736-176_29e2c4ed-e924-4184-8e78-16e8391ba04a 63736-176 HUMAN OTC DRUG Chooz Calcium Carbonate GUM, CHEWING ORAL 20090610 OTC MONOGRAPH FINAL part331 Insight Pharmaceuticals CALCIUM CARBONATE 500 mg/1 63736-196_879e373b-f5cf-41d6-876a-2d0d06d9501b 63736-196 HUMAN OTC DRUG Sucrets Black Cherry Dyclonine Hydrochloride LOZENGE ORAL 20090618 OTC MONOGRAPH FINAL part356 Insight Pharmaceuticals LLC DYCLONINE HYDROCHLORIDE 3 mg/1 63736-200_ebc1a540-0330-42d5-a7c6-dc1f6fd2b59a 63736-200 HUMAN OTC DRUG Anacin Asprin and Caffeine TABLET ORAL 20090625 OTC MONOGRAPH NOT FINAL part343 Insight Pharmaceuticals ASPIRIN; CAFFEINE 40; 32 mg/1; mg/1 63736-203_985f601f-d2a0-45dd-817c-bee0d67c4bbf 63736-203 HUMAN OTC DRUG Anacin AF Acetaminophen, Aspirin and Caffeine TABLET, COATED ORAL 20090629 OTC MONOGRAPH NOT FINAL part343 Insight Pharmaceuticals ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 63736-204_47ce071f-b6e0-4f55-a269-418ec4d34546 63736-204 HUMAN OTC DRUG Cepastat Cherry Phenol LOZENGE ORAL 20090629 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals PHENOL 14.5 mg/1 63736-206_97ac18d0-6ddf-4331-9f22-f6a56dcb5d90 63736-206 HUMAN OTC DRUG Anacin Aspirin and Caffeine CAPSULE, COATED ORAL 20090629 OTC MONOGRAPH FINAL part343 Insight Pharmaceuticals LLC ASPIRIN; CAFFEINE 400; 32 mg/1; mg/1 63736-210_2d148ca6-9415-44c3-a791-d5d3ce13ea7c 63736-210 HUMAN OTC DRUG Pronto Plus Lice Killing Pyrethrum Extract and Piperonyl Butoxide SHAMPOO TOPICAL 20101201 OTC MONOGRAPH FINAL part358G Insight Pharmaceuticals LLC PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT .04; .0033 mL/mL; mL/mL 63736-211_795ca46a-30b9-49eb-aaac-f68d2c7e7bb8 63736-211 HUMAN OTC DRUG Anacin ES Aspirin and Caffeine TABLET, COATED ORAL 20090707 OTC MONOGRAPH NOT FINAL part343 Insight Pharmaceuticals ASPIRIN; CAFFEINE 500; 32 mg/1; mg/1 63736-219_a33617f8-fc6a-4c06-8f96-fed5b5d6d570 63736-219 HUMAN OTC DRUG Cepastat Extra Strength Phenol LOZENGE ORAL 20090707 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals PHENOL 29 mg/1 63736-232_017403c5-1be2-46a2-a6eb-63d15265d4ca 63736-232 HUMAN OTC DRUG Auro Ear Wax Remover Carbamide peroxide LIQUID AURICULAR (OTIC) 20100701 OTC MONOGRAPH FINAL part344 Insight Pharmaceuticals LLC CARBAMIDE PEROXIDE 1.44 mL/22mL 63736-238_800fac99-b869-45bb-a1f0-4670ea3df88b 63736-238 HUMAN OTC DRUG Stye Mineral Oil and Petrolatum GEL OPHTHALMIC 20100615 OTC MONOGRAPH FINAL part349 Insight Pharmaceuticals MINERAL OIL; PETROLATUM 1; 2 g/4g; g/4g 63736-240_05954178-f513-4240-95b8-a411715f05d3 63736-240 HUMAN OTC DRUG Pronto Plus Pinworm Treatment Pyrantel pamoate LIQUID ORAL 20100920 OTC MONOGRAPH FINAL part357B Insight Pharmaceuticals LLC PYRANTEL PAMOATE 5 mL/250mL 63736-293_6265bf84-0828-494b-b781-55351012e3e4 63736-293 HUMAN OTC DRUG Skin Shield Benzethonium Chloride and Dyclonine Hydrochloride LIQUID TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part333A Insight Pharmaceuticals BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .0532; .0997 mL/27mL; mL/27mL 63736-301_6cf8da32-4bef-4532-a6c3-900f345e07d7 63736-301 HUMAN OTC DRUG Dermarest Psoriasis Medicated Skin Treatment Salicylic Acid GEL TOPICAL 20101020 OTC MONOGRAPH NOT FINAL part358H Insight Pharmaceuticals SALICYLIC ACID 3.54 mL/118mL 63736-302_83c9b426-86c9-4e30-91f7-5700ace9789f 63736-302 HUMAN OTC DRUG Dermarest Psoriasis Medicated Salicylic Acid LIQUID TOPICAL 20100723 OTC MONOGRAPH FINAL part358H Insight Pharmaceuticals LLC SALICYLIC ACID 7.08 mL/236mL 63736-305_b27a6d5f-5310-4a83-82b0-1a06b9e9859e 63736-305 HUMAN OTC DRUG Caldesene Baby Starch, Corn and Zinc Oxide POWDER TOPICAL 20090707 OTC MONOGRAPH NOT FINAL part347 Insight Pharmaceuticals STARCH, CORN; ZINC OXIDE 115; 21 g/142g; g/142g 63736-310_cdf01a8d-2a77-4338-b5a2-57e836712975 63736-310 HUMAN OTC DRUG Anacin Aspirin Free Acetaminophen CAPSULE ORAL 20090709 OTC MONOGRAPH NOT FINAL part343 Insight Pharmaceuticals LLC ACETAMINOPHEN 500 mg/1 63736-312_c15309eb-3948-49f3-b790-7105b8493440 63736-312 HUMAN OTC DRUG Dermarest Psoriasis Medicated Scalp Treatment Salicylic Acid GEL TOPICAL 20101220 OTC MONOGRAPH FINAL part358H Insight Pharmaceuticals LLC SALICYLIC ACID 3.54 mL/118mL 63736-318_de833a93-7751-40ff-a620-ea7e5d4d8def 63736-318 HUMAN OTC DRUG Gentle Naturals Matricaria Recutita, Tribasic Calcium Phosphate, Potassium Phosphate, Dibasic, Magnesium Phosphate, Dibasic Trihydrate, and Delphinium Staphisagria Seed LIQUID ORAL 20100620 UNAPPROVED HOMEOPATHIC Insight Pharmaceuticals DELPHINIUM STAPHISAGRIA SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; POTASSIUM PHOSPHATE, DIBASIC; TRIBASIC CALCIUM PHOSPHATE 9; 6; 30; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 63736-324_67d0e4a6-91ac-4aac-bc2d-87cbc131529a 63736-324 HUMAN OTC DRUG Auro Earache Relief MATRICARIA RECUTITA, PLANTAGO MAJOR, VERBASCUM THAPSUS, ATROPA BELLADONNA, CHILI PEPPER, OYSTER SHELL CALCIUM CARBONATE, CRUDE, and POTASSIUM DICHROMATE LIQUID AURICULAR (OTIC) 20100601 UNAPPROVED HOMEOPATHIC Insight Pharmaceuticals ATROPA BELLADONNA; CHILI PEPPER; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PLANTAGO MAJOR; POTASSIUM DICHROMATE; VERBASCUM THAPSUS .3256; .3256; 4; .3256; .3256; .3256; .3256 mL/30mL; mL/30mL; mL/30mL; mL/30mL; mL/30mL; mL/30mL; mL/30mL 63736-325_36307499-f128-45d6-854a-7fe179d26f6d 63736-325 HUMAN OTC DRUG Dermarest Eczema Medicated Moist for Sensitive Skin Pramoxine Hydrochloride CREAM TOPICAL 20100723 OTC MONOGRAPH NOT FINAL part348 Insight Pharmaceuticals LLC PRAMOXINE HYDROCHLORIDE 1 g/57g 63736-326_8c257f57-671e-42fd-89a7-e24af7082aa4 63736-326 HUMAN OTC DRUG Auro Homeopathic Ear Relief Drops Atropa Belladonna, Oyster Shell Calcium Carbonate, Crude, Capsicum, Matricaria Recutita, Potassium Dichromate, Plantago Major, and Verbascum Thapsus LIQUID AURICULAR (OTIC) 20131115 UNAPPROVED HOMEOPATHIC Insight Pharmaceuticals ATROPA BELLADONNA; CAPSICUM; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PLANTAGO MAJOR; POTASSIUM DICHROMATE; VERBASCUM THAPSUS 18; 6; 15; 12; 4; 12; 4 [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL 63736-327_28ec5b8b-66e1-4285-b1b2-1304c8aed1be 63736-327 HUMAN OTC DRUG Auro-Dri Isopropyl Alcohol LIQUID AURICULAR (OTIC) 20100614 OTC MONOGRAPH FINAL part344 Insight Pharmaceuticals ISOPROPYL ALCOHOL 28 mL/29mL 63736-339_f46a5a8c-9fdf-4039-9159-d452feadc409 63736-339 HUMAN OTC DRUG Dermarest Eczema Medicated Hydrocortisone LOTION TOPICAL 20100920 OTC MONOGRAPH NOT FINAL part348 Insight Pharmaceuticals HYDROCORTISONE 1.18 mL/118mL 63736-340_2472480b-14b6-4e03-bfaf-0f8d3e4594aa 63736-340 HUMAN OTC DRUG Eucalyptamint Menthol OINTMENT TOPICAL 20090709 OTC MONOGRAPH NOT FINAL part348 Insight Pharmaceuticals MENTHOL 9.6 mL/60mL 63736-363_f824f2dc-d361-4c3b-bd4e-cea9ca147dae 63736-363 HUMAN OTC DRUG Caldesene Talc and Zinc Oxide POWDER TOPICAL 20090709 OTC MONOGRAPH NOT FINAL part347 Insight Pharmaceuticals TALC; ZINC OXIDE 57.51; 10.65 g/71g; g/71g 63736-375_766759f1-70ac-4b7b-91cf-849dddfa2fec 63736-375 HUMAN OTC DRUG Americaine Benzocaine OINTMENT TOPICAL 20090710 OTC MONOGRAPH FINAL part346 Insight Pharmaceuticals BENZOCAINE 5.6 g/28g 63736-378_8e8a523a-63a8-4680-8189-174f6e91795d 63736-378 HUMAN OTC DRUG Americaine Benzocaine AEROSOL, SPRAY TOPICAL 20090714 OTC MONOGRAPH NOT FINAL part348 Insight Pharmaceuticals BENZOCAINE 11.4 g/57g 63736-400_f555ffc6-b1ac-4c89-bef9-60bcde655e27 63736-400 HUMAN OTC DRUG Sucrets Herbal Honey Lemon Ginseng Menthol and Pectin LOZENGE ORAL 20090714 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals LLC MENTHOL; PECTIN 5; 6 mg/1; mg/1 63736-404_24a93c17-af04-4c0c-9d02-a70ddb715aaa 63736-404 HUMAN OTC DRUG Diabet Aid Capsicum Oleoresin LOTION TOPICAL 20100607 OTC MONOGRAPH NOT FINAL part348 Insight Pharmaceuticals CAPSICUM OLEORESIN 3 g/113g 63736-410_561d72af-1eae-4009-8576-afc274365166 63736-410 HUMAN OTC DRUG Tioconazole 1 Day Tioconazole OINTMENT TOPICAL 20011121 ANDA ANDA075915 Insight Pharmaceuticals LLC TIOCONAZOLE 300 mg/g 63736-419_e85cea35-5dae-4c9b-8dcb-983ce6464bce 63736-419 HUMAN OTC DRUG Sucrets Herbal Berry Pomegranate Menthol and Pectin LOZENGE ORAL 20090714 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals LLC MENTHOL; PECTIN 5; 6 mg/1; mg/1 63736-502_b36a4627-e8e6-4667-8e72-6703d2547c7c 63736-502 HUMAN OTC DRUG Nice Cherry Menthol LOZENGE ORAL 20090625 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals MENTHOL 5.5 mg/1 63736-520_93d47cd6-9f6f-460f-b1ec-3e338f9a1569 63736-520 HUMAN OTC DRUG Sucrets Cough Cherry Dextromethorphan Hydrobromide LOZENGE ORAL 20090714 OTC MONOGRAPH FINAL part341 Insight Pharmaceuticals LLC DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 63736-532_1f5ea87d-b3e2-452b-bddd-219cf9f80fcd 63736-532 HUMAN OTC DRUG Ting Spray Powder Miconazole Nitrate AEROSOL, POWDER TOPICAL 20090716 OTC MONOGRAPH FINAL part333 Insight Pharmaceuticals MICONAZOLE NITRATE 2.56 g/128g 63736-566_7eccd317-9724-439a-a119-4bc8735b8ebd 63736-566 HUMAN OTC DRUG Sucrets Cough Honey Lemon Dextromethorphan Hydrobromide LOZENGE ORAL 20090716 OTC MONOGRAPH FINAL part341 Insight Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 63736-586_5297cdf2-d4a4-4b19-b16a-8c016a6be23e 63736-586 HUMAN OTC DRUG Allerest PE Chlorpheniramine Maleate and Phenylephrine Hydrochloride TABLET ORAL 20090731 OTC MONOGRAPH FINAL part341 Insight Pharmaceuticals CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 63736-594_6c6cc20d-fe7a-4f3e-b708-45bc8be5fef3 63736-594 HUMAN OTC DRUG Nice Citrus Menthol LOZENGE ORAL 20090716 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals MENTHOL 5 mg/1 63736-622_b3ac18f4-d118-4e23-aaa5-d51352789b8c 63736-622 HUMAN OTC DRUG Nice Honey Lemon Menthol LOZENGE ORAL 20090716 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals MENTHOL 5 mg/1 63736-646_08ea15b8-9433-4cd6-a456-16efb078dda8 63736-646 HUMAN OTC DRUG Caldecort Hydrocortisone CREAM TOPICAL 20090716 OTC MONOGRAPH NOT FINAL part348 Insight Pharmaceuticals HYDROCORTISONE .284 g/28.4g 63736-662_2584355b-c068-4bca-87f6-7854da08610b 63736-662 HUMAN OTC DRUG Privine Naphazoline Hydrochloride SPRAY NASAL 20090716 OTC MONOGRAPH FINAL part341 Insight Pharmaceuticals NAPHAZOLINE HYDROCHLORIDE .1 mL/20mL 63736-663_8541b271-ccd6-4c6d-9797-60335e7e4d22 63736-663 HUMAN OTC DRUG Privine Naphazoline Hydrochloride SUSPENSION/ DROPS NASAL 20090716 OTC MONOGRAPH FINAL part341 Insight Pharmaceuticals LLC NAPHAZOLINE HYDROCHLORIDE .125 mL/25mL 63736-730_a1afa60c-122e-4135-8714-c8b5d10849d1 63736-730 HUMAN OTC DRUG Nostrilla Oxymetazoline Hydrochloride SPRAY, METERED NASAL 20090608 OTC MONOGRAPH FINAL part341 Insight Pharmaceuticals OXYMETAZOLINE HYDROCHLORIDE .0005 mL/100mL 63736-819_3fa290e6-1dca-4df3-b43b-c6b4f68ea468 63736-819 HUMAN OTC DRUG Ting Tolnaftate AEROSOL, SPRAY TOPICAL 20090727 OTC MONOGRAPH FINAL part333 Insight Pharmaceuticals TOLNAFTATE 1.28 g/128g 63736-850_8ed2b1a5-3eba-4fae-8164-d567889bbd47 63736-850 HUMAN OTC DRUG Sucrets Wild Cherry Dyclonine Hydrochloride LOZENGE ORAL 20090728 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals LLC DYCLONINE HYDROCHLORIDE 2 mg/1 63736-851_8f5f9759-5375-4a6a-a50e-959e41be419d 63736-851 HUMAN OTC DRUG Sucrets Original Mint Hexylresorcinol LOZENGE ORAL 20090728 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals HEXYLRESORCINOL 2.4 mg/1 63736-859_85885ef3-e7a3-4315-b100-448bc13fea9d 63736-859 HUMAN OTC DRUG Nice Assorted menthol LOZENGE ORAL 20090728 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals MENTHOL 5 mg/1 63736-860_47b53f38-1d99-4e5b-b70b-225a7f3c79d1 63736-860 HUMAN OTC DRUG Nice Cherry Menthol LOZENGE ORAL 20090728 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals MENTHOL 5 mg/1 63736-902_1fad1c25-2d1a-4e6e-8fd0-433819dc9da0 63736-902 HUMAN OTC DRUG Sucrets Childrens Cherry Dyclonine Hydrochloride LOZENGE ORAL 20090728 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals DYCLONINE HYDROCHLORIDE 1.2 mg/1 63736-910_0eaa709d-56b2-4cf8-9c26-fab0ed8a53d4 63736-910 HUMAN OTC DRUG Sucrets Complete Cool Citrus Dyclonine Hydrochloride and Menthol LOZENGE ORAL 20090728 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals LLC DYCLONINE HYDROCHLORIDE; MENTHOL 3; 6 mg/1; mg/1 63736-915_ea86fcf2-54a8-4e55-b3f4-f6253ee26129 63736-915 HUMAN OTC DRUG Sucrets MS Wintergreen Dyclonine Hydrochloride LOZENGE ORAL 20090728 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals DYCLONINE HYDROCHLORIDE 3 mg/1 63736-918_ceab14ed-d49a-44e7-ae85-6117fdc83a96 63736-918 HUMAN OTC DRUG Sucrets Ice Pomegranate Menthol and Pectin LIQUID ORAL 20090728 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals MENTHOL; PECTIN 3.3; 12.5 mg/25mL; mg/25mL 63736-919_938b605d-130a-4f28-973f-4bb3d27edf70 63736-919 HUMAN OTC DRUG Sucrets Ice Grape Menthol and Pectin LIQUID ORAL 20090728 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals MENTHOL; PECTIN 3.3; 12.5 mg/25mL; mg/25mL 63736-920_69e602c4-85c4-4b79-ba38-f16063084cc1 63736-920 HUMAN OTC DRUG Sucrets Complete Vapor Cherry Dyclonine Hydrochloride and Menthol LOZENGE ORAL 20090731 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals DYCLONINE HYDROCHLORIDE; MENTHOL 3; 6 mg/1; mg/1 63736-948_cf40c987-0850-4c04-a72e-248b30226453 63736-948 HUMAN OTC DRUG Nice Menthol Menthol LOZENGE ORAL 20090728 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals MENTHOL 5 mg/1 63739-004_8579c0e9-48bf-438e-a783-2f2b6c99944e 63739-004 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine Phosphate acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 Mckesson Packaging Services a business unit of McKesson Corporation ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 63739-046_30ec915a-9a98-4ab6-965c-24a140fbba63 63739-046 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19930301 ANDA ANDA073618 McKesson Packaging Services a business unit of McKesson Corporation CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 63739-047_30ec915a-9a98-4ab6-965c-24a140fbba63 63739-047 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19930401 ANDA ANDA073589 McKesson Packaging Services a business unit of McKesson Corporation CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 63739-048_30ec915a-9a98-4ab6-965c-24a140fbba63 63739-048 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19930101 ANDA ANDA073607 McKesson Packaging Services a business unit of McKesson Corporation CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 63739-049_7bba1e10-82df-4161-b397-01b4e513c364 63739-049 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 McKesson Packaging Services a business unit of McKesson Corporation CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 63739-059_363d5e7d-2734-4a26-8b7c-a75a707dbaae 63739-059 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20070806 ANDA ANDA063083 McKesson Packaging Services Business Unit of McKesson Corporation CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 63739-060_f84327ee-ffe0-43bd-b431-98b15d3ad15e 63739-060 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070974 McKesson Packaging Services a business unit of McKesson Corporation CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 63739-066_61b5704e-b635-4e3f-b6f9-a7faf5d3b6b6 63739-066 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20070614 ANDA ANDA071611 McKesson Packaging Services Business Unit of McKesson Corporation CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63739-073_e78b85c4-d403-43be-93e6-8cf85ed63215 63739-073 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20061115 ANDA ANDA071135 McKesson Packaging Services Business Unit of McKesson Corporation DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 63739-079_da1c1a8e-c9dd-4c20-b061-638f2d0cecda 63739-079 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, COATED ORAL 20070810 ANDA ANDA074185 McKesson Packaging Services Business Unit of McKesson Corporation DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63739-080_da1c1a8e-c9dd-4c20-b061-638f2d0cecda 63739-080 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, COATED ORAL 20070810 ANDA ANDA074185 McKesson Packaging Services Business Unit of McKesson Corporation DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63739-089_62c8ffe5-321f-4747-ad38-db2c54a393ae 63739-089 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20041201 UNAPPROVED DRUG OTHER McKesson Packaging Services Business Unit of McKesson Corporation DOCUSATE SODIUM 100 mg/1 63739-110_a912f6c4-2ca6-438e-912c-4acf02a3e0bd 63739-110 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20041124 ANDA ANDA080600 McKesson Packaging Services Business Unit of McKesson Corporation. FOLIC ACID 1 mg/1 63739-111_a0f067c5-d2bd-46b0-96a2-22b0c1421b47 63739-111 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20041001 ANDA ANDA018569 McKesson Packaging Services Business Unit of McKesson Corporation FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63739-113_a0f067c5-d2bd-46b0-96a2-22b0c1421b47 63739-113 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20041001 ANDA ANDA018569 McKesson Packaging Services Business Unit of McKesson Corporation FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63739-119_f4be13b7-9382-482a-8407-dcef987f2692 63739-119 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 McKesson Packaging Services a business unit of McKesson Corporation GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 63739-126_1c96ac21-455e-4f14-bc5d-141ef4a1d3fc 63739-126 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19900930 ANDA ANDA088467 McKesson Packaging Services a business unit of McKesson Corporation HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 63739-127_1c96ac21-455e-4f14-bc5d-141ef4a1d3fc 63739-127 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19900930 ANDA ANDA088468 McKesson Packaging Services a business unit of McKesson Corporation HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 63739-128_69854128-4e2c-4a86-be4a-74fbad253f49 63739-128 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 McKesson Packaging Services a business unit of McKesson Corporation HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63739-131_1cfb6720-c52d-4d84-b4a5-b63570b239bd 63739-131 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20041222 ANDA ANDA040157 McKesson Packaging Services a business unit of McKesson Corproration ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63739-134_3d055404-f915-40a4-8f8f-7bc72ee2ce02 63739-134 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, SUGAR COATED ORAL 20050110 ANDA ANDA071163 McKesson Packaging Services Business Unit of McKesson Corporation IBUPROFEN 200 mg/1 63739-141_1cfb6720-c52d-4d84-b4a5-b63570b239bd 63739-141 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20050322 ANDA ANDA040144 McKesson Packaging Services a business unit of McKesson Corproration ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63739-154_d200ba28-2c61-4bd1-9f00-817e6f3c4be5 63739-154 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19990728 ANDA ANDA071193 McKesson Packaging Services Business Unit of McKesson Corporation LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63739-155_d200ba28-2c61-4bd1-9f00-817e6f3c4be5 63739-155 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19990728 ANDA ANDA071194 McKesson Packaging Services Business Unit of McKesson Corporation LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63739-156_d200ba28-2c61-4bd1-9f00-817e6f3c4be5 63739-156 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19990728 ANDA ANDA071195 McKesson Packaging Services Business Unit of McKesson Corporation LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63739-165_1e5e6461-83a0-4d6d-b5b0-d84e00e536ed 63739-165 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 20070820 ANDA ANDA072423 McKesson Packaging Services a business unit of McKesson Corporation MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 63739-166_a106efef-a36d-49e2-b527-754228d2c6d7 63739-166 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 McKesson Packaging Services a business unit of McKesson Corporation METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63739-167_a106efef-a36d-49e2-b527-754228d2c6d7 63739-167 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 McKesson Packaging Services a business unit of McKesson Corporation METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63739-200_7b15c232-d2d8-41f6-b45a-475405c02fb0 63739-200 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20070905 UNAPPROVED DRUG OTHER McKesson Packaging Services Business Unit of McKesson Corporation PHENOBARBITAL 16.2 mg/1 CIV 63739-201_7b15c232-d2d8-41f6-b45a-475405c02fb0 63739-201 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20070717 UNAPPROVED DRUG OTHER McKesson Packaging Services Business Unit of McKesson Corporation PHENOBARBITAL 32.4 mg/1 CIV 63739-213_818a4d9a-c8a2-476c-b70c-0840b6d603a1 63739-213 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20080824 ANDA ANDA084234 McKesson Packaging Services Business Unit of McKesson Corporation PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 63739-228_4c19426b-91c8-46a3-ab23-19bb84281424 63739-228 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20070924 ANDA ANDA071017 McKesson Packaging Services a business unit of McKesson Corporation SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 63739-231_a7ba7574-261c-4f43-8dae-b44250ce6077 63739-231 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20070913 ANDA ANDA071427 McKesson Packaging Services a business unit of McKesson Corporation TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63739-251_54bcb1e8-4763-47ad-80c8-4b052cf8ef58 63739-251 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid CAPSULE, LIQUID FILLED ORAL 20050301 ANDA ANDA073229 McKesson Packaging Services Business Unit of McKesson Corporation VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 63739-263_e0c27a29-b895-4132-a2c2-8da4c0722d03 63739-263 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20070801 ANDA ANDA074869 McKesson Packaging Services Business Unit of McKesson Corporation CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63739-264_e0c27a29-b895-4132-a2c2-8da4c0722d03 63739-264 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20070802 ANDA ANDA074869 McKesson Packaging Services Business Unit of McKesson Corporation CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63739-265_f051f7f1-5b1d-4256-af2b-266cef308233 63739-265 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20070719 ANDA ANDA076243 McKesson Packaging Services a business unit of McKesson Corporation LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 63739-266_7b5c59ae-e4c1-4097-9db1-f6837b7c3688 63739-266 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20040701 ANDA ANDA075180 McKesson Packaging Services Business Unit of McKesson Corporation RANITIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63739-269_03aa160e-65cb-4bc7-afd8-157666e39b8c 63739-269 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20070914 ANDA ANDA075797 McKesson Packaging Services Business Unit of McKesson Corporation TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 63739-281_722a733e-60ee-4ef8-83d8-a3196160ac76 63739-281 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20070912 ANDA ANDA075828 McKesson Packaging Services Business Unit of McKesson Corporation LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63739-282_722a733e-60ee-4ef8-83d8-a3196160ac76 63739-282 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20070806 ANDA ANDA075828 McKesson Packaging Services Business Unit of McKesson Corporation LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63739-283_13b758d6-fbd8-4783-80c5-fcfa7f3abe42 63739-283 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100524 ANDA ANDA074984 McKesson Packaging Services Business Unit of McKesson Corporation DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63739-283_889623a1-666e-40d8-a3c7-6abbe22bd2bb 63739-283 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070724 ANDA ANDA074984 McKesson Packaging Services Business Unit of McKesson Corporation DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63739-284_13b758d6-fbd8-4783-80c5-fcfa7f3abe42 63739-284 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100524 ANDA ANDA074984 McKesson Packaging Services Business Unit of McKesson Corporation DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63739-284_889623a1-666e-40d8-a3c7-6abbe22bd2bb 63739-284 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070621 ANDA ANDA074984 McKesson Packaging Services Business Unit of McKesson Corporation DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63739-285_13b758d6-fbd8-4783-80c5-fcfa7f3abe42 63739-285 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100524 ANDA ANDA074984 McKesson Packaging Services Business Unit of McKesson Corporation DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63739-285_889623a1-666e-40d8-a3c7-6abbe22bd2bb 63739-285 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070724 ANDA ANDA074984 McKesson Packaging Services Business Unit of McKesson Corporation DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 63739-291_bba98e57-7056-4143-8fcd-95e25539d087 63739-291 HUMAN OTC DRUG Oyster Shell Calcium with Vitamin D Oyster Shell Calcium with Vitamin D TABLET, FILM COATED ORAL 20051115 UNAPPROVED DRUG OTHER McKesson Packaging Services Business Unit of McKesson Corporation CALCIUM; CHOLECALCIFEROL 500; 200 mg/1; [iU]/1 63739-325_991d2b13-f491-4a25-8ea7-5136d0585874 63739-325 HUMAN PRESCRIPTION DRUG FAMOTIDINE FAMOTIDINE TABLET, FILM COATED ORAL 20070612 ANDA ANDA075718 McKesson Packaging Services Business Unit of McKesson Corporation FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63739-349_57787670-4749-454d-8a71-12a606f9a451 63739-349 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 McKesson Packaging Services a business unit of McKesson Corporation LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63739-350_57787670-4749-454d-8a71-12a606f9a451 63739-350 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 McKesson Packaging Services a business unit of McKesson Corporation LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 63739-355_4531cb5a-64ca-4e6a-98c2-7aaad8d7f630 63739-355 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070807 ANDA ANDA076119 McKesson Packaging Services Business Unit of McKesson Corporation MIRTAZAPINE 15 mg/1 63739-356_4531cb5a-64ca-4e6a-98c2-7aaad8d7f630 63739-356 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070914 ANDA ANDA076119 McKesson Packaging Services Business Unit of McKesson Corporation MIRTAZAPINE 30 mg/1 63739-358_00c75eba-5e07-4849-accc-900e845f2c40 63739-358 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20021104 ANDA ANDA075410 McKesson Packaging Services a business unit of McKesson Corporation OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 63739-366_3fa8706c-41d1-4526-917f-bdd3b808fa4a 63739-366 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20061115 ANDA ANDA075113 McKesson Packaging Services a business unit of McKesson Corporation LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63739-374_60d80bdc-3dbc-4c36-8b78-98e2d9de1425 63739-374 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 McKesson Packaging Services a business unit of McKesson Corporation GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63739-375_60d80bdc-3dbc-4c36-8b78-98e2d9de1425 63739-375 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 McKesson Packaging Services a business unit of McKesson Corporation GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63739-376_60d80bdc-3dbc-4c36-8b78-98e2d9de1425 63739-376 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 McKesson Packaging Services a business unit of McKesson Corporation GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63739-387_e6ab9ade-0c29-4526-b027-60e165dff075 63739-387 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20080301 ANDA ANDA075315 McKesson Packaging a business unit of McKesson Corporation AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 63739-389_818a4d9a-c8a2-476c-b70c-0840b6d603a1 63739-389 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20090824 ANDA ANDA084176 McKesson Packaging Services Business Unit of McKesson Corporation PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 63739-391_e35a7856-eb8c-4cf1-9749-f9ee52678360 63739-391 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20040214 ANDA ANDA075694 McKesson Packaging Services a business unit of McKesson Corporation GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63739-404_4813f476-3637-4f0f-abdd-c76c4074f8ae 63739-404 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20061115 ANDA ANDA076466 McKesson Packaging Services a business unit of McKesson Corporation METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 63739-415_36579a56-4555-4211-93c5-bb7d9a729b01 63739-415 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20061130 ANDA ANDA064150 McKesson Packaging Services a business unit of McKesson Corporation RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 63739-416_922b2c82-052a-416c-984f-0dd66f2c61c4 63739-416 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20090818 ANDA ANDA089424 McKesson Packaging Services Business Unit of McKesson Corporation SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 63739-431_7a0b096b-ab37-4ffd-8d88-7f91e6ed60da 63739-431 HUMAN OTC DRUG Senna-Time Senna-Time TABLET, COATED ORAL 20071012 UNAPPROVED DRUG OTHER McKesson Packaging Services Business Unit of McKesson Corporation SENNOSIDES 8.6 mg/1 63739-432_4258fc68-ac29-491c-b7bc-ed5d35b23107 63739-432 HUMAN OTC DRUG Sennosides and Docusate Sodium Sennosides and Docusate Sodium TABLET ORAL 20071011 UNAPPROVED DRUG OTHER McKesson Packaging Services a business unit of McKesson Corporation DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 63739-435_5977d097-7eb5-48c8-be1b-e0e7ddb1ffa2 63739-435 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080331 ANDA ANDA077837 McKesson Packaging Services a business unit of McKesson Corporation SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63739-436_5977d097-7eb5-48c8-be1b-e0e7ddb1ffa2 63739-436 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080331 ANDA ANDA077837 McKesson Packaging Services a business unit of McKesson Corporation SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63739-437_5977d097-7eb5-48c8-be1b-e0e7ddb1ffa2 63739-437 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080331 ANDA ANDA077837 McKesson Packaging Services a business unit of McKesson Corporation SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63739-438_5977d097-7eb5-48c8-be1b-e0e7ddb1ffa2 63739-438 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080331 ANDA ANDA077837 McKesson Packaging Services a business unit of McKesson Corporation SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63739-440_9e296255-930d-4162-b0c2-a38ebc1d74d5 63739-440 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20090301 OTC MONOGRAPH NOT FINAL part343 McKesson Packaging Services Business Unit of McKesson Corporation ACETAMINOPHEN 325 mg/1 63739-442_02aa4acb-3bd4-4606-b7c8-3b6ca41919e0 63739-442 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20090720 ANDA ANDA075682 McKesson Packaging Services a business unit of McKesson Corporation IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63739-443_02aa4acb-3bd4-4606-b7c8-3b6ca41919e0 63739-443 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20090709 ANDA ANDA075682 McKesson Packaging Services a business unit of McKesson Corporation IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63739-444_02aa4acb-3bd4-4606-b7c8-3b6ca41919e0 63739-444 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20090617 ANDA ANDA075682 McKesson Packaging Services a business unit of McKesson Corporation IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63739-445_00c75eba-5e07-4849-accc-900e845f2c40 63739-445 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20090123 ANDA ANDA075410 McKesson Packaging Services a business unit of McKesson Corporation OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 63739-446_e3deb79f-888c-4ebc-8b30-c5256d2b9a06 63739-446 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20090803 ANDA ANDA074726 McKesson Packaging Services Business Unit of McKesson Corporation POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 63739-447_e3deb79f-888c-4ebc-8b30-c5256d2b9a06 63739-447 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20090810 ANDA ANDA074726 McKesson Packaging Services Business Unit of McKesson Corporation POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 63739-448_d44bd66b-90e6-4447-803c-7c3bc02bf877 63739-448 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20100120 ANDA ANDA076708 McKesson Packaging Services Business Unit of McKesson Corporation LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 63739-449_8ad0c59a-8772-4c94-809a-aaccecadab60 63739-449 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100331 ANDA ANDA077285 McKesson Packaging Services a Business unit of McKesson Corporation BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 63739-450_8ad0c59a-8772-4c94-809a-aaccecadab60 63739-450 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100331 ANDA ANDA077285 McKesson Packaging Services a Business unit of McKesson Corporation BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 63739-451_b95cd483-64ca-4840-948d-eaf1e13e58b2 63739-451 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20100719 ANDA ANDA077899 McKesson Packaging Services Business Unit of McKesson Corporation NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63739-452_b95cd483-64ca-4840-948d-eaf1e13e58b2 63739-452 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20100719 ANDA ANDA077899 McKesson Packaging Services Business Unit of McKesson Corporation NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63739-454_361cc106-6167-43e1-93af-46b3faa5cedf 63739-454 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20110202 ANDA ANDA077298 McKesson Packaging Services Business Unit of McKesson Corporation METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 63739-455_084efc66-f1e9-4000-8694-e251b41b5991 63739-455 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100729 ANDA ANDA089160 McKesson Packaging Services Business Unit of McKesson Corporation ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63739-456_3af22732-ff86-4ae2-813a-d2bcf0924471 63739-456 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION INTRACARDIAC; INTRAVENOUS 20100503 NDA NDA020800 McKesson Packaging Services Business Unit of McKesson Corporation EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 63739-457_95e8a1e3-04c7-433f-ae8c-afa1c0d61deb 63739-457 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20100503 ANDA ANDA040302 McKesson Packaging Services Business Unit of McKesson Corporation LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63739-459_4e23837d-d376-4c8e-a94e-1ddb585dbbf7 63739-459 HUMAN PRESCRIPTION DRUG Procainamide Hydrochloride Procainamide Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100201 ANDA ANDA089069 McKesson Packaging Services Business Unit of McKesson Corporation PROCAINAMIDE HYDROCHLORIDE 100 mg/mL Antiarrhythmic [EPC] 63739-460_343adf7b-6aaf-47a0-8419-a67cd09363dc 63739-460 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION, SOLUTION INTRAVENOUS 20100503 NDA NDA077394 McKesson Packaging Services Business Unit of McKesson Corporation SODIUM BICARBONATE 84 mg/mL 63739-461_4dffbd3a-95e3-4147-9b85-b91b278a5a16 63739-461 HUMAN PRESCRIPTION DRUG Dextrose Dextrose INJECTION, SOLUTION INTRAVENOUS 20100503 UNAPPROVED DRUG OTHER McKesson Packaging Services Business Unit of McKesson Corporation DEXTROSE 25 g/50mL 63739-463_1a757301-419a-457e-9989-cdf57c902988 63739-463 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100503 ANDA ANDA070254 McKesson Packaging Services Business Unit of McKesson Corporation NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 63739-464_19152554-70b0-42fb-a3d5-65ceb00e60e3 63739-464 HUMAN PRESCRIPTION DRUG Furosemide furosemide INJECTION INTRAMUSCULAR; INTRAVENOUS 20100201 NDA NDA018579 McKesson Packaging Services Business unit of McKesson Corporation FUROSEMIDE 20 mg/2mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63739-466_ee8fe2ea-a6c7-485e-bea9-1b94ff66b05c 63739-466 HUMAN PRESCRIPTION DRUG Nalbuphine Hydrochloride Nalbuphine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100503 ANDA ANDA070916 McKesson Packaging Services Business Unit of McKesson Corporation NALBUPHINE HYDROCHLORIDE 20 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] 63739-467_d785beac-3f68-4df1-926f-34da6773f295 63739-467 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100503 UNAPPROVED DRUG OTHER McKesson Packaging Services Business Unit of McKesson Corporation EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 63739-468_3365c3d6-28a0-420d-89a7-9bc9b8539d4c 63739-468 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine lidocaine hydrochloride anhydrous and epinephrine INJECTION, SOLUTION INFILTRATION 20100503 ANDA ANDA089644 McKesson Packaging Services Business Unit of McKesson Corporation EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 10 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 63739-469_195030df-bf46-49f7-9fc0-1351100a7d41 63739-469 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100503 ANDA ANDA088299 McKesson Packaging Services Business Unit of McKesson Corporation LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63739-470_195030df-bf46-49f7-9fc0-1351100a7d41 63739-470 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100503 ANDA ANDA088327 McKesson Packaging Services Business Unit of McKesson Corporation LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63739-471_4ab56689-687b-4417-a877-a4d68c558e14 63739-471 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAVENOUS 20100503 NDA NDA018800 McKesson Packaging Services Business Unit of McKesson Corporation SODIUM CHLORIDE 9 mg/mL 63739-472_7dad59b7-0ae1-4750-9122-9ab103db4bf0 63739-472 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR 20100503 ANDA ANDA074802 McKesson Packaging Services Business Unit of McKesson Corporation KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63739-475_3365c3d6-28a0-420d-89a7-9bc9b8539d4c 63739-475 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine lidocaine hydrochloride anhydrous and epinephrine INJECTION, SOLUTION INFILTRATION 20100503 ANDA ANDA089646 McKesson Packaging Services Business Unit of McKesson Corporation EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ANHYDROUS 10; 20 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 63739-478_f730ce28-428e-462d-bde8-72e345c283bc 63739-478 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20101109 UNAPPROVED DRUG OTHER McKesson Packaging Services Business Unit of McKesson Corporation DOCUSATE SODIUM 100 mg/1 63739-479_4a25139b-8a90-4740-92e3-dfb4d0b884c3 63739-479 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20110411 ANDA ANDA078504 McKesson Packaging Services a business unit of McKesson Corporation BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 63739-480_4a25139b-8a90-4740-92e3-dfb4d0b884c3 63739-480 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20110531 ANDA ANDA078504 McKesson Packaging Services a business unit of McKesson Corporation BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 63739-481_4b240b5f-18ac-4bd7-9385-59569cb570d8 63739-481 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110317 ANDA ANDA078374 McKesson Packaging Services a business unit of McKesson Corporation METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 63739-482_4b240b5f-18ac-4bd7-9385-59569cb570d8 63739-482 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110317 ANDA ANDA078374 McKesson Packaging Services a business unit of McKesson Corporation METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 63739-483_da488d09-6cdb-497d-b9c8-d36e16c3822b 63739-483 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride HydrOXYzine Hydrochloride TABLET ORAL 20110301 ANDA ANDA040841 McKesson Packaging Services Business Unit of McKesson Corporation HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 63739-484_e68099da-81c1-4e8c-84bd-8ed9ffcd41ef 63739-484 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20090701 ANDA ANDA078916 McKesson Packaging Services a business unit of McKesson Corporation FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63739-486_da488d09-6cdb-497d-b9c8-d36e16c3822b 63739-486 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride HydrOXYzine Hydrochloride TABLET ORAL 20110301 ANDA ANDA040842 McKesson Packaging Services Business Unit of McKesson Corporation HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 63739-489_a35fe4f2-e63d-4503-9e81-852376f2476e 63739-489 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20121106 ANDA ANDA077824 McKesson Packaging Services Business Unit of McKesson Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 63739-490_e6d920ee-80bc-4247-8b50-77f463130d38 63739-490 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20101201 ANDA ANDA077206 McKesson Packaging Services Business Unit of McKesson Corporation SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63739-493_59de2889-c3d3-4ebf-8826-13f30a3fa439 63739-493 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Capsules CAPSULE ORAL 20101118 ANDA ANDA090223 McKesson Packaging Services Business Unit of McKesson Corporation FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63739-494_59de2889-c3d3-4ebf-8826-13f30a3fa439 63739-494 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Capsules CAPSULE ORAL 20101118 ANDA ANDA090223 McKesson Packaging Services Business Unit of McKesson Corporation FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63739-495_da78d7ba-d9de-4b04-b088-640547ae1a98 63739-495 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20101122 ANDA ANDA077914 McKesson Packaging Services Business Unit of McKesson Corporation FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 63739-499_ee1d91f5-5330-4a09-9dc5-fb1505a507cc 63739-499 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100901 ANDA ANDA072926 McKesson Packaging Services Business Unit of McKesson Corporation LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63739-500_ee1d91f5-5330-4a09-9dc5-fb1505a507cc 63739-500 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100901 ANDA ANDA072927 McKesson Packaging Services Business Unit of McKesson Corporation LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63739-501_ee1d91f5-5330-4a09-9dc5-fb1505a507cc 63739-501 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100901 ANDA ANDA072928 McKesson Packaging Services Business Unit of McKesson Corporation LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63739-509_cf103bcc-5b96-4699-be2c-d596d490a814 63739-509 HUMAN PRESCRIPTION DRUG Propafenone HCl Propafenone hydrochloride TABLET, FILM COATED ORAL 20120910 ANDA ANDA075203 McKesson Packaging Services a business unit of McKesson Corporation PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] 63739-510_cf103bcc-5b96-4699-be2c-d596d490a814 63739-510 HUMAN PRESCRIPTION DRUG Propafenone HCl Propafenone hydrochloride TABLET, FILM COATED ORAL 20120910 ANDA ANDA075203 McKesson Packaging Services a business unit of McKesson Corporation PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] 63739-512_008aaf35-b9ca-4e0a-8713-c6d5cb80b2f5 63739-512 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121015 ANDA ANDA076565 McKesson Packaging Services a business unit of McKesson Corporation VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63739-513_4b85bb76-96b1-4854-8946-50611ca48382 63739-513 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090382 McKesson Packaging Services a business unit of McKesson Corporation LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63739-514_4b85bb76-96b1-4854-8946-50611ca48382 63739-514 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090382 McKesson Packaging Services a business unit of McKesson Corporation LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63739-515_4b85bb76-96b1-4854-8946-50611ca48382 63739-515 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090382 McKesson Packaging Services a business unit of McKesson Corporation LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 63739-516_5fb7c70d-410f-46a6-9906-edd5106c34d0 63739-516 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110608 ANDA ANDA090607 McKesson Packaging Services a buisness unit of McKesson Corporation LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 63739-517_5fb7c70d-410f-46a6-9906-edd5106c34d0 63739-517 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110608 ANDA ANDA090607 McKesson Packaging Services a buisness unit of McKesson Corporation LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 63739-518_5c0d93cb-c49f-4c1c-bc63-236c9a86c9c5 63739-518 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 McKesson Packaging Services a business unit of McKesson Corporation PREDNISONE 5 mg/1 63739-519_5c0d93cb-c49f-4c1c-bc63-236c9a86c9c5 63739-519 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 McKesson Packaging Services a business unit of McKesson Corporation PREDNISONE 10 mg/1 63739-520_5c0d93cb-c49f-4c1c-bc63-236c9a86c9c5 63739-520 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 McKesson Packaging Services a business unit of McKesson Corporation PREDNISONE 20 mg/1 63739-522_3e8bb204-a480-4a74-bfb6-28be4e69c2ad 63739-522 HUMAN OTC DRUG aspirin low dose enteric coated aspirin TABLET, COATED ORAL 20121113 OTC MONOGRAPH FINAL part343 McKesson Packaging Services Business Unit of McKesson Corporation ASPIRIN 81 mg/1 63739-523_62dda51f-68bc-4f3c-833b-3c0ae516a5de 63739-523 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength Aspirin TABLET, DELAYED RELEASE ORAL 20130628 OTC MONOGRAPH FINAL part343 Mckesson Packaging Services a business unit of Mckesson Corporation ASPIRIN 325 mg/3251 63739-525_bb76a751-0ed6-41ab-89b4-1376bced9509 63739-525 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20110523 ANDA ANDA090682 McKesson Packaging Services a business unit of McKesson Corporation VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63739-526_db6549a5-4883-4fd7-8a10-04f90913bbc7 63739-526 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20110601 ANDA ANDA078413 McKesson Packaging Services Business Unit of McKesson Corporation ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 63739-527_768a363a-c814-4ef5-a37f-90fddf690c07 63739-527 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20110601 ANDA ANDA091629 McKesson Packaging Services a business unit of McKesson Corporation HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63739-528_768a363a-c814-4ef5-a37f-90fddf690c07 63739-528 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20110601 ANDA ANDA091629 McKesson Packaging Services a business unit of McKesson Corporation HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63739-529_768a363a-c814-4ef5-a37f-90fddf690c07 63739-529 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20110601 ANDA ANDA091629 McKesson Packaging Services a business unit of McKesson Corporation HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 63739-531_ac09241f-3425-4c26-8401-73b093ca13a6 63739-531 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 McKesson Packaging Services a business unit of McKesson Corporation CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 63739-532_1cfb6720-c52d-4d84-b4a5-b63570b239bd 63739-532 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20111101 ANDA ANDA040655 McKesson Packaging Services a business unit of McKesson Corproration ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63739-537_975e93c6-6204-4a5e-bf37-2d3131f3f309 63739-537 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20111017 ANDA ANDA040756 McKesson Packaging Services a business unit of McKesson Corporation FOLIC ACID 1 mg/1 63739-538_d21e0f18-ea2d-4be0-8f2e-78637126504e 63739-538 HUMAN PRESCRIPTION DRUG Lactulose lactulose SOLUTION ORAL 20111101 ANDA ANDA075993 McKesson Packaging Services a business unit of McKesson Corporation LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 63739-539_ded90f0c-9b55-4e67-b49e-f029df4bd16e 63739-539 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20111101 ANDA ANDA079107 McKesson Packaging Services a business unit of McKesson Corporation LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63739-541_13d7784b-a9b8-48cd-950a-8e94b37b02c4 63739-541 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110822 ANDA ANDA078010 McKesson Packaging Services a business unit of McKesson Corporation FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63739-542_13d7784b-a9b8-48cd-950a-8e94b37b02c4 63739-542 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110725 ANDA ANDA078010 McKesson Packaging Services a business unit of McKesson Corporation FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63739-543_13d7784b-a9b8-48cd-950a-8e94b37b02c4 63739-543 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110822 ANDA ANDA078010 McKesson Packaging Services a business unit of McKesson Corporation FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 63739-544_2c7d3a90-bd99-4fb3-8d26-366d69aee184 63739-544 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20110601 ANDA ANDA091426 McKesson Packaging Services a business unit of McKesson Corporation SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 63739-545_2c7d3a90-bd99-4fb3-8d26-366d69aee184 63739-545 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20110601 ANDA ANDA091426 McKesson Packaging Services a business unit of McKesson Corporation SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 63739-546_9ebb0568-141c-43d0-8056-a9afe4ce3d4e 63739-546 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20120213 ANDA ANDA078707 McKesson Packaging Services a business unit of McKesson Corporation RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 63739-547_9ebb0568-141c-43d0-8056-a9afe4ce3d4e 63739-547 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20120319 ANDA ANDA078707 McKesson Packaging Services a business unit of McKesson Corporation RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 63739-548_c8a755b6-881f-4568-8d1b-1347755230c9 63739-548 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20120518 ANDA ANDA078503 McKesson Packaging Services a business unit of McKesson Corporation OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 63739-549_3d8419fa-e990-4183-93bc-dce26295d25a 63739-549 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20130308 ANDA ANDA075671 McKesson Packaging Services a business unit of McKesson Corporation MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 63739-552_bb76a751-0ed6-41ab-89b4-1376bced9509 63739-552 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20120224 ANDA ANDA090682 McKesson Packaging Services a business unit of McKesson Corporation VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 63739-553_0f132d75-af5c-4ac1-8e46-afd6ef10a0d5 63739-553 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120123 ANDA ANDA078853 McKesson Packaging Services a business unit of McKesson Corporation DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 63739-554_0f132d75-af5c-4ac1-8e46-afd6ef10a0d5 63739-554 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120123 ANDA ANDA078853 McKesson Packaging Services a business unit of McKesson Corporation DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 63739-555_fb615f0b-67ff-4a7f-b1b8-70095f054b51 63739-555 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120921 ANDA ANDA091269 McKesson Packaging Services a business unit of McKesson Corporation LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 63739-556_2b24f75c-539b-4a96-802e-f3cc3b55dae2 63739-556 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20121126 ANDA ANDA076514 McKesson Packaging Services a business unit of McKesson Corporation MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 63739-557_b27e79b9-42b0-4c56-a1da-512e0742a13f 63739-557 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20120521 ANDA ANDA076642 McKesson Packaging Services a business unit of McKesson Corporation HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 63739-559_f38e618b-539b-426b-aef2-8194f63e918d 63739-559 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20121120 ANDA ANDA077859 McKesson Packaging Services a business unit of McKesson Corporation CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 63739-564_199d4792-2b36-47d0-81f1-99e29810e36b 63739-564 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 McKesson Packaging Services a business unit of McKesson Corporation PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 63739-567_45e97516-5a96-470d-92e2-dd9d85bb170c 63739-567 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078225 McKesson Packaging Services a business unit of McKesson Corporation TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 63739-570_0876c6ec-99cf-466d-ae83-9531c0fab1e9 63739-570 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130117 ANDA ANDA077691 McKesson Packaging Services a business unit of McKesson Corporation SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63739-571_0876c6ec-99cf-466d-ae83-9531c0fab1e9 63739-571 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20121220 ANDA ANDA077691 McKesson Packaging Services a business unit of McKesson Corporation SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63739-572_0876c6ec-99cf-466d-ae83-9531c0fab1e9 63739-572 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20121122 ANDA ANDA077691 McKesson Packaging Services a business unit of McKesson Corporation SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63739-573_0876c6ec-99cf-466d-ae83-9531c0fab1e9 63739-573 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20121122 ANDA ANDA077691 McKesson Packaging Services a business unit of McKesson Corporation SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 63739-574_fb615f0b-67ff-4a7f-b1b8-70095f054b51 63739-574 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120921 ANDA ANDA091269 McKesson Packaging Services a business unit of McKesson Corporation LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 63739-575_a4c8bd5b-9606-4fa1-91c1-1f1752317c73 63739-575 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20131202 ANDA ANDA065211 McKesson Packaging Services a Business Unit of McKesson Corporation AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 63739-576_8dc97a13-c5eb-4421-ae86-7e0877186e2d 63739-576 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20130301 ANDA ANDA077129 McKesson Packaging Services a business unit of McKesson Corporation RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 63739-577_8dc97a13-c5eb-4421-ae86-7e0877186e2d 63739-577 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20130201 ANDA ANDA077129 McKesson Packaging Services a business unit of McKesson Corporation RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 63739-578_8dc97a13-c5eb-4421-ae86-7e0877186e2d 63739-578 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20130301 ANDA ANDA077129 McKesson Packaging Services a business unit of McKesson Corporation RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 63739-579_8dc97a13-c5eb-4421-ae86-7e0877186e2d 63739-579 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20130301 ANDA ANDA077129 McKesson Packaging Services a business unit of McKesson Corporation RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 63739-588_480e2573-7ad2-48a0-9c97-bcc5587aa7fe 63739-588 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA085161 McKesson Packaging Services a business unit or McKesson Corporation PREDNISONE 20 mg/1 63739-631_e062d365-fda8-4c9e-b4b8-3d273153c50c 63739-631 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070921 ANDA ANDA078226 McKesson Packaging Services a business unit of McKesson Corporation AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63739-633_e10b61c2-f4cd-45e6-821f-48033fdd9100 63739-633 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140527 ANDA ANDA078865 McKesson Packaging Services a business unit of McKesson Corporation VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 63739-640_60909fe2-ec22-4fa5-ac5c-da143290a378 63739-640 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20140527 ANDA ANDA075967 McKesson Packaging Services a business unit of McKesson Corporation METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 63739-644_85219ef9-d2ff-4037-b398-fae5e277ed4e 63739-644 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20140429 ANDA ANDA074112 McKesson Packaging Services a business unit of McKesson Corporation ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63739-652_76cd10c9-3513-4648-af43-0d5b7de982b5 63739-652 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20130308 ANDA ANDA090175 McKesson Packaging Services a business unit of McKesson Corporation DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 63739-653_76cd10c9-3513-4648-af43-0d5b7de982b5 63739-653 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20130308 ANDA ANDA090175 McKesson Packaging Services a business unit of McKesson Corporation DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 63739-665_1de66e94-0669-4098-90d6-4c62ef5f114d 63739-665 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 McKesson Packaging Services a business unit of McKesson Corporation QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 63739-667_f83e1f85-caaa-4cb7-8af3-c3d36139139c 63739-667 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20130308 ANDA ANDA076786 McKesson Packaging Services a business unit of McKesson Corporation DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 63739-668_f83e1f85-caaa-4cb7-8af3-c3d36139139c 63739-668 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20130308 ANDA ANDA076786 McKesson Packaging Services a business unit of McKesson Corporation DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 63739-669_85219ef9-d2ff-4037-b398-fae5e277ed4e 63739-669 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20140429 ANDA ANDA074112 McKesson Packaging Services a business unit of McKesson Corporation ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63739-670_5bb31c31-86f9-4ef6-8b94-d6d778079561 63739-670 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20140205 ANDA ANDA077633 McKesson Packaging Sevices a business unit of McKesson Corporation LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 63739-671_8ad9d318-4968-4dba-8898-83c286aad2ef 63739-671 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20131202 ANDA ANDA076003 McKesson Packaging Services a business unit of McKesson Corporation TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 63739-672_cf05b0a3-c94b-4d36-bff2-0eb4cd0b3b74 63739-672 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 McKesson Packaging Serivces a business unit of McKesson Corporation IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63739-674_85219ef9-d2ff-4037-b398-fae5e277ed4e 63739-674 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20140429 ANDA ANDA074112 McKesson Packaging Services a business unit of McKesson Corporation ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63739-675_81437733-9a56-42b3-ab28-fb58bfbb0f9d 63739-675 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 McKesson Packaging Services a business unit of McKesson Corporation GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63739-677_1de66e94-0669-4098-90d6-4c62ef5f114d 63739-677 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 McKesson Packaging Services a business unit of McKesson Corporation QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 63739-684_cf05b0a3-c94b-4d36-bff2-0eb4cd0b3b74 63739-684 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 McKesson Packaging Serivces a business unit of McKesson Corporation IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63739-689_81437733-9a56-42b3-ab28-fb58bfbb0f9d 63739-689 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 McKesson Packaging Services a business unit of McKesson Corporation GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63739-690_1de66e94-0669-4098-90d6-4c62ef5f114d 63739-690 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 McKesson Packaging Services a business unit of McKesson Corporation QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 63739-691_cf05b0a3-c94b-4d36-bff2-0eb4cd0b3b74 63739-691 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 McKesson Packaging Serivces a business unit of McKesson Corporation IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63739-693_81437733-9a56-42b3-ab28-fb58bfbb0f9d 63739-693 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 McKesson Packaging Services a business unit of McKesson Corporation GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63739-694_68afe518-0c35-40ea-8914-95884d9d52f4 63739-694 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION OROPHARYNGEAL 20070227 ANDA ANDA040708 McKesson Packaging Services a business unit of McKesson Corporation LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 63739-704_107033c5-679b-487c-aa33-49e8c35c6419 63739-704 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20111101 ANDA ANDA040655 McKesson Packaging Services a business unit of McKesson Corproration ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 63739-800_24845e58-5bfe-4a74-beec-696a564fb68c 63739-800 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20110701 ANDA ANDA074514 McKesson Packaging Services a business unit of McKesson Corporation DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63739-801_88a7a828-f3f6-4b10-bb24-60903d5b5579 63739-801 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20110701 ANDA ANDA089160 McKesson Packaging Services a business unit of McKesson Corporation ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63739-802_a53ee482-0e0c-4e68-9a07-26a3c0ddec35 63739-802 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110701 ANDA ANDA078203 McKesson Packaging Services a business unit of McKesson Corporation LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63739-803_a53ee482-0e0c-4e68-9a07-26a3c0ddec35 63739-803 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110701 ANDA ANDA078203 McKesson Packaging Services a business unit of McKesson Corporation LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63739-804_a53ee482-0e0c-4e68-9a07-26a3c0ddec35 63739-804 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110701 ANDA ANDA078203 McKesson Packaging Services a business unit of McKesson Corporation LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 63739-805_75f6811d-0906-4ed4-8619-eb3eed103d9b 63739-805 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20110701 ANDA ANDA077899 McKesson Packaging Servives a business unit of McKesson Corporation NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 63739-809_87733712-26ae-4a15-8a98-5def6476d4d3 63739-809 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20121029 ANDA ANDA075350 McKesson Packaging Services a business unit of McKesson Corporation GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 63739-811_acbaeb6c-1198-4d11-8016-e8b6dcbbc5d9 63739-811 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130220 ANDA ANDA078801 McKesson Packaging Services a business unit of McKesson Corporation TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 63739-900_603e9307-361f-42d2-9263-dc5f5b267028 63739-900 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA202732 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63739-901_84bd38d6-15e1-4e69-b9c6-5ae0a4d87160 63739-901 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA202733 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63739-920_861acd7a-4ca8-4717-afe3-71a14a8ffe01 63739-920 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA202957 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63739-931_861acd7a-4ca8-4717-afe3-71a14a8ffe01 63739-931 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA202957 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63739-942_861acd7a-4ca8-4717-afe3-71a14a8ffe01 63739-942 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA202957 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63739-953_861acd7a-4ca8-4717-afe3-71a14a8ffe01 63739-953 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA202957 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63739-964_861acd7a-4ca8-4717-afe3-71a14a8ffe01 63739-964 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA203198 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63739-975_861acd7a-4ca8-4717-afe3-71a14a8ffe01 63739-975 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA203198 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63739-986_861acd7a-4ca8-4717-afe3-71a14a8ffe01 63739-986 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA203198 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 20000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] 63742-001_3fd4a3fb-6ae3-4029-83d7-cd5192668be4 63742-001 HUMAN OTC DRUG NUMB MASTER Topical Anesthetic LIDOCAINE CREAM TOPICAL 20140424 OTC MONOGRAPH FINAL part346 Clinical Resolution Laboratory, Inc. LIDOCAINE 5 g/100g 63755-0001_b1ef2cae-fd59-43fd-9b99-bc8072bb9dce 63755-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19971106 UNAPPROVED MEDICAL GAS Fleming County Hospital Home Medical Equipment OXYGEN 99 L/100L 63763-515_5f70b47c-f1a5-447e-bba7-8c74cfe64cf5 63763-515 HUMAN OTC DRUG LUCASOL Hand Instant Hand Sanitizer ethanol GEL TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Lucas Products Corporation ETHANOL 600 mL/1000mL 63766-001_171ffb4b-5819-4ff2-b2fa-2cf1817020d4 63766-001 HUMAN OTC DRUG KERACARE Menthol 1% GEL, DENTIFRICE TOPICAL 20140406 OTC MONOGRAPH NOT FINAL part348 Avlon Industries, Inc. MENTHOL 10 mg/g 63776-027_14cba036-4e43-5eb9-46b8-a19b1e361bed 63776-027 HUMAN OTC DRUG Aller Balance acetylcholine chloride, bos taurus adrenal gland, sus scrofa adrenal gland, epinephrine, onion, ammonium carbonate, apis mellifera, arsenic trioxide, histamine, interferon gamma-1a, interleukin-12 human, manganese gluconate, luffa operculata fruit, sus scrofa lung, beef lung, sus scrofa nasal mucosa, bos taurus nasal mucosa, sodium chloride, bos taurus peyers patch, sus scrofa peyers patch, schoenocaulon officinale seed, serotonin, bos taurus thymus, sus scrofa thymus SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ACETYLCHOLINE CHLORIDE; AMMONIUM CARBONATE; APIS MELLIFERA; ARSENIC TRIOXIDE; BEEF LUNG; BOS TAURUS ADRENAL GLAND; BOS TAURUS NASAL MUCOSA; BOS TAURUS PEYER'S PATCH; BOS TAURUS THYMUS; EPINEPHRINE; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; LUFFA OPERCULATA FRUIT; MANGANESE GLUCONATE; ONION; SCHOENOCAULON OFFICINALE SEED; SEROTONIN; SODIUM CHLORIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SUS SCROFA PEYER'S PATCH; SUS SCROFA THYMUS 200; 200; 200; 200; 200; 200; 200; 30; 200; 30; 200; 200; 200; 30; 4; 200; 200; 200; 200; 200; 200; 200; 30; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-033_4ce67602-bf54-711f-4ffc-159979422218 63776-033 HUMAN OTC DRUG ANS/CNS acetylcholine chloride, epinephrine, .gamma.-aminobutyric acid, histamine, goldenseal, norepinephrine, taraxacum palustre root, tyramine SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED .GAMMA.-AMINOBUTYRIC ACID; ACETYLCHOLINE CHLORIDE; EPINEPHRINE; GOLDENSEAL; HISTAMINE; NOREPINEPHRINE; TARAXACUM PALUSTRE ROOT; TYRAMINE 200; 200; 200; 3; 200; 200; 30; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-035_b5d2533f-b56f-5019-5487-ff8454ead7eb 63776-035 HUMAN OTC DRUG Arthros anti-interleukin-1.alpha. immunoglobulin g rabbit, .alpha.-ketoglutaric acid, .alpha.-lipoic acid, apomorphine, bos taurus joint capsule, sus scrofa joint capsule, ascorbic acid, bos taurus adrenal gland, sus scrofa adrenal gland, brain-derived neurotrophic factor human, metenkefalin, ersofermin, bos taurus solar plexus, sus scrofa solar plexus, calcitonin, bos taurus cartilage, sus scrofa cartilage, colchicum autumnale bulb, pork collagen, bos taurus red blood cell, sus scrofa red blood cell SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; ASCORBIC ACID; BEEF LIVER; BOS TAURUS ADRENAL GLAND; BOS TAURUS CARTILAGE; BOS TAURUS JOINT CAPSULE; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PLACENTA; BOS TAURUS RED BLOOD CELL; BOS TAURUS SOLAR PLEXUS; BOS TAURUS VEIN; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; CALCITONIN; COLCHICUM AUTUMNALE BULB; EDODEKIN ALFA; ERSOFERMIN; INTERFERON GAMMA-1A; METENKEFALIN; NADIDE; PORK COLLAGEN; PORK LIVER; QUINHYDRONE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA CARTILAGE; SUS SCROFA JOINT CAPSULE; SUS SCROFA LYMPH; SUS SCROFA MESENCHYME; SUS SCROFA PARATHYROID GLAND; SUS SCROFA RED BLOOD CELL; SUS SCROFA SOLAR PLEXUS; SUS SCROFA VEIN 30; 30; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 200; 30 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-037_90d22de7-bd8f-eb46-06af-e970b0b5b81a 63776-037 HUMAN OTC DRUG Articula anti-interleukin-1.alpha. immunoglobulin g rabbit, bos taurus ankle joint, sus scrofa ankle joint, metenkefalin, ersofermin, bos taurus achilles tendon, sus scrofa achilles tendon, bos taurus hip joint, sus scrofa hip joint, bos taurus knee joint, sus scrofa knee joint, beef liver, pork liver, transforming growth factor beta-1, avotermin SPRAY ORAL 20120326 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; AVOTERMIN; BEEF LIVER; BOS TAURUS ACHILLES TENDON; BOS TAURUS ANKLE JOINT; BOS TAURUS HIP JOINT; BOS TAURUS KNEE JOINT; ERSOFERMIN; METENKEFALIN; PORK LIVER; SUS SCROFA ACHILLES TENDON; SUS SCROFA ANKLE JOINT; SUS SCROFA HIP JOINT; SUS SCROFA KNEE JOINT; TRANSFORMING GROWTH FACTOR BETA-1 200; 30; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 30 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-073_a4028286-90a3-ea37-d4d6-51caaa10aaa3 63776-073 HUMAN OTC DRUG Candida ammoniac, aspergillus niger var. niger, caffeic acid, candida albicans, candida parapsilosis, ipecac, lycopodium clavatum spore, yeast mannan, penicillin g sodium, vaccinium vitis-idaea leaf SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED AMMONIAC; ASPERGILLUS NIGER VAR. NIGER; CAFFEIC ACID; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; PENICILLIN G SODIUM; VACCINIUM VITIS-IDAEA LEAF; YEAST MANNAN 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-075_92011176-3db5-9279-ef11-4b738ce28822 63776-075 HUMAN OTC DRUG Candida I caffeic acid, candida albicans, tanacetum parthenium, centella asiatica, yeast mannan, penicillin g, vaccinium vitis-idaea leaf spray SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED CAFFEIC ACID; CANDIDA ALBICANS; CENTELLA ASIATICA; PENICILLIN G; TANACETUM PARTHENIUM; VACCINIUM VITIS-IDAEA LEAF; YEAST MANNAN 200; 200; 200; 200; 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-095_ea3ceded-98eb-73ca-2edc-aacf19ea53ab 63776-095 HUMAN OTC DRUG Collagen Pork Collagen SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED PORK COLLAGEN 200 {kp_C}/mL 63776-100_cf02c3f6-035a-2ba1-1d08-6e76af8ecea5 63776-100 HUMAN OTC DRUG Connectissue anti-interleukin-1.alpha. immunoglobulin g rabbit, ascorbic acid, metenkefalin, ersofermin, bos taurus cartilage, sus scrofa cartilage, pork collagen, bos taurus red blood cell, sus scrofa red blood cell, interleukin-3, interleukin-3, beef liver, pork liver, beef, pork, bos taurus tendon, sus scrofa tendon, cetermin SPRAY ORAL 20120326 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ASCORBIC ACID; BEEF; BEEF LIVER; BOS TAURUS CARTILAGE; BOS TAURUS RED BLOOD CELL; BOS TAURUS TENDON; CETERMIN; ERSOFERMIN; INTERLEUKIN-3; METENKEFALIN; PORK; PORK COLLAGEN; PORK LIVER; SUS SCROFA CARTILAGE; SUS SCROFA RED BLOOD CELL; SUS SCROFA TENDON 200; 30; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-165_6c7638cc-a11b-3a68-c69b-6b0ca2d90a4b 63776-165 HUMAN OTC DRUG Foods activated charcoal, ageratina aromatica root, ferrous iodide, gelsemium sempervirens root, calcium sulfide, histamine, interleukin-12 human, interferon gamma-1a, iodine, potassium gluconate, lycopodium clavatum spore, cajuput oil, black currant, rosa canina fruit, serotonin, xanthine, almond, apple, banana, barley, bean, beef, cashew, casein, emmental cultured, casein, lactococcus lactis cultured, casein, lactococcus lactis cultured aged, casein, lactococcus lactis cultured SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ACTIVATED CHARCOAL; AGERATINA AROMATICA ROOT; ALMOND; APPLE; ARCHED SWIMMING CRAB, COOKED; BANANA; BARLEY; BEAN; BEEF; BLACK CURRANT; BLUE CRAB; BROWN RICE; CAJUPUT OIL; CALCIUM SULFIDE; CASEIN, EMMENTAL CULTURED; CASEIN, LACTOCOCCUS LACTIS CULTURED; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; CASHEW; CHICKEN; COCOA; COCONUT; COD, UNSPECIFIED; COFFEE BEAN; COTTON FIBER; COTTON SEED; COW MILK; DUNGENESS CRAB, COOKED; EGG; EGGPLANT; ENGLISH WALNUT; FERROUS IODIDE; FLAX SEED; GELSEMIUM SEMPERVIRENS ROOT; GREEN BELL PEPPER; HAZELNUT, UNSPECIFIED; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; IODINE; LAMB; LYCOPODIUM CLAVATUM SPORE; ONION; ORANGE; OYSTER, UNSPECIFIED; PEANUT; PECAN; PORK; POTASSIUM GLUCONATE; POTATO; ROSA CANINA FRUIT; SALMON, UNSPECIFIED; SEROTONIN; SERRATED SWIMMING CRAB, COOKED; SHRIMP, UNSPECIFIED; SNOW CRAB, UNSPECIFIED; SOYBEAN; STARCH, RICE; STRAWBERRY; TEA LEAF; TOMATO; TUNA, UNSPECIFIED; WHEAT; WHEAT GLUTEN; WHITE RICE; XANTHINE 30; 30; 30; 30; 30; 30; 30; 30; 30; 1; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 1; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-170_c422823a-4990-0cc8-7f82-c93c008e57ea 63776-170 HUMAN OTC DRUG Female bos taurus adrenal gland, sus scrofa adrenal gland, cholesterol, sus scrofa corpus luteum, esterified estrogen, bos taurus hypothalamus, sus scrofa hypothalamus, melatonin, bos taurus ovary, sus scrofa ovary, bos taurus pancreas, sus scrofa pancreas, bos taurus pineal gland, sus scrofa pineal gland, bos taurus pituitary gland, sus scrofa pituitary gland, progesterone, sus scrofa thalamus, bos taurus thymus, sus scrofa thymus, thyroid bovine, thyroid porcine SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED BOS TAURUS ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; BOS TAURUS OVARY; BOS TAURUS PANCREAS; BOS TAURUS PINEAL GLAND; BOS TAURUS PITUITARY GLAND; BOS TAURUS THYMUS; CHOLESTEROL; ESTROGENS, ESTERIFIED; MELATONIN; PROGESTERONE; SUS SCROFA ADRENAL GLAND; SUS SCROFA CORPUS LUTEUM; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PANCREAS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THALAMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-244_56311048-8bc5-4fb8-38d2-a611c74724cc 63776-244 HUMAN OTC DRUG Immunexx bos taurus adrenal gland, sus scrofa adrenal gland, ascorbic acid, bos taurus bone marrow, sus scrofa bone marrow, bos taurus red blood cell, sus scrofa red blood cell, filgrastim, aldesleukin, interferon gamma-1a, bos taurus lymph, sus scrofa lymph, bos taurus peyers patches, sus scrofa small intestine mucosa lymph follicle, bos taurus thymus, sus scrofa thymus SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ALDESLEUKIN; ASCORBIC ACID; BOS TAURUS ADRENAL GLAND; BOS TAURUS BONE MARROW; BOS TAURUS LYMPH; BOS TAURUS PEYER'S PATCH; BOS TAURUS RED BLOOD CELL; BOS TAURUS THYMUS; FILGRASTIM; INTERFERON GAMMA-1A; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA LYMPH; SUS SCROFA PEYER'S PATCH; SUS SCROFA RED BLOOD CELL; SUS SCROFA THYMUS 200; 30; 200; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-249_54ffa8a7-4d8a-9dd9-c871-1d829e0449c5 63776-249 HUMAN OTC DRUG Infla aconitum napellus, anti-interleukin-1.alpha. immunoglobulin g rabbit, apis mellifera, bos taurus adrenal gland, sus scrofa adrenal gland, atropa belladonna, metenkefalin, citric acid monohydrate, bos taurus solar plexus, sus scrofa solar plexus, bryonia alba root, interleukin-10, bos taurus mesenchyme, sus scrofa mesenchyme, sodium pyruvate, bos taurus pineal gland, sus scrofa pineal gland, bos taurus pituitary gland, sus scrofa pituitary gland, rancid beef, transforming growth factor beta-1, avotermin SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ACONITUM NAPELLUS; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APIS MELLIFERA; ATROPA BELLADONNA; AVOTERMIN; BOS TAURUS ADRENAL GLAND; BOS TAURUS MESENCHYME; BOS TAURUS PINEAL GLAND; BOS TAURUS PITUITARY GLAND; BOS TAURUS SOLAR PLEXUS; BRYONIA ALBA ROOT; CITRIC ACID MONOHYDRATE; INTERLEUKIN-10; METENKEFALIN; RANCID BEEF; SODIUM PYRUVATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA MESENCHYME; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA SOLAR PLEXUS; TRANSFORMING GROWTH FACTOR BETA-1 200; 30; 200; 200; 30; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 30; 200; 200; 30 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-250_70902074-c75e-b43b-bb25-908578491120 63776-250 HUMAN OTC DRUG Intra-cell ingredients SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED .ALPHA.-LIPOIC ACID; .ALPHA.-TOCOPHEROL; ACETYLCARNITINE; ADENOSINE TRIPHOSPHATE; ASCORBIC ACID; CALCIUM GLUCONATE; CITRIC ACID MONOHYDRATE; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; CUPRIC SULFATE; CYANOCOBALAMIN; FERRIC CHLORIDE HEXAHYDRATE; FOLIC ACID; FUMARIC ACID; LACTIC ACID; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; MANGANESE GLUCONATE; MANGANESE PHOSPHATE, DIBASIC; MERCURIUS SOLUBILIS; NIACIN; PANTOTHENIC ACID; PHOSPHORUS; PODOPHYLLUM; POTASSIUM ASPARTATE; PYRIDOXINE; PYRUVALDEHYDE; QUINHYDRONE; RIBOFLAVIN; SACCHAROMYCES CEREVISIAE RNA; SELENOMETHIONINE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SULFUR; THIAMINE; UBIDECARENONE; WATER; ZINC GLUCONATE 30; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-270_858be7d9-0912-c546-1e51-ba6642ca2e56 63776-270 HUMAN OTC DRUG Ithurts anti-interleukin-1.alpha. apomorphine, metenkefalin SPRAY ORAL 20120326 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; METENKEFALIN 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-300_064c5bdc-a947-909e-cb8d-272512cc99c9 63776-300 HUMAN OTC DRUG Liver centaurea benedicta, silybum marianum seed, ceanothus americanus leaf, chelidonium majus, chionanthus virginicus bark, choline, bos taurus solar plexus, sus scrofa solar plexus, bos taurus duodenum, sus scrofa duodenum, fumaric acid, bos taurus gallbladder, sus scrofa gallbladder, inositol, binetrakin, potassium sulfate, beef liver, pork liver, lycopodium clavatum spore, sodium diethyl oxalacetate, sodium pyruvate, sodium sulfate, niacin, bos taurus pancreas, sus scrofa pancreas SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED BEEF LIVER; BINETRAKIN; BOS TAURUS DUODENUM; BOS TAURUS GALLBLADDER; BOS TAURUS PANCREAS; BOS TAURUS SOLAR PLEXUS; BOS TAURUS SPLEEN; BOS TAURUS VEIN; CEANOTHUS AMERICANUS LEAF; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CHOLINE; CYANOCOBALAMIN; FUMARIC ACID; INOSITOL; LYCOPODIUM CLAVATUM SPORE; NIACIN; PORK LIVER; POTASSIUM SULFATE; PYRIDOXINE; RIBOFLAVIN; SILYBUM MARIANUM SEED; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; SUS SCROFA DUODENUM; SUS SCROFA GALLBLADDER; SUS SCROFA PANCREAS; SUS SCROFA SOLAR PLEXUS; SUS SCROFA SPLEEN; SUS SCROFA VEIN; TARAXACUM OFFICINALE; THIAMINE 200; 200; 30; 30; 200; 200; 200; 30; 6; 30; 30; 6; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 200; 30; 30; 30 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-310_3a84f6b7-ab6b-db86-f584-21594e9366de 63776-310 HUMAN OTC DRUG Lymph 1 alcohol, fumaria officinalis flowering top, calcium sulfide, bos taurus lymph, sus scrofa lymph, pinus sylvestris leafy twig, green peppercorn, prunus spinosa flower bud, silicon dioxide, bos taurus spleen, sus scrofa spleen, sulfuric acid SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ALCOHOL; BOS TAURUS LYMPH; BOS TAURUS SPLEEN; FUMARIA OFFICINALIS FLOWERING TOP; GREEN PEPPERCORN; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA LYMPH; SUS SCROFA SPLEEN 30; 200; 200; 30; 30; 30; 30; 30; 200; 30; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-320_bc6face2-4010-d6ac-4f0f-3a485d9ac97d 63776-320 HUMAN OTC DRUG Male plus bos taurus adrenal gland, sus scrofa adrenal gland, aldosterone, androsterone, adenosine cyclic 3,5-phosphate, cholesterol, prasterone, somatropin, bos taurus hypothalamus, sus scrofa hypothalamus, melatonin, bos taurus pancreas, sus scrofa pancreas, bos taurus pineal gland, sus scrofa pineal gland, bos taurus pituitary gland, sus scrofa pituitary gland, bos taurus prostate gland, sus scrofa prostate, bos taurus testicle, sus scrofa testicle, testosterone, sus scrofa thalamus SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ADENOSINE CYCLIC 3',5'-PHOSPHATE; ALDOSTERONE; ANDROSTERONE; BOS TAURUS ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; BOS TAURUS PANCREAS; BOS TAURUS PINEAL GLAND; BOS TAURUS PITUITARY GLAND; BOS TAURUS PROSTATE GLAND; BOS TAURUS TESTICLE; BOS TAURUS THYMUS; CHOLESTEROL; MELATONIN; PRASTERONE; SOMATROPIN; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PANCREAS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; SUS SCROFA TESTICLE; SUS SCROFA THALAMUS; SUS SCROFA THYMUS; TESTOSTERONE; THYROID, BOVINE; THYROID, PORCINE 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-347_e242a0db-5fc6-817a-f20e-03d6b75b480a 63776-347 HUMAN OTC DRUG MuSkel-S anti-interleukin-1.alpha. immunoglobulin g rabbit, bos taurus ankle joint, sus scrofa ankle joint, bos taurus joint capsule, sus scrofa joint capsule, brain-derived neurotrophic factor human, metenkefalin, ersofermin, bos taurus solar plexus, sus scrofa solar plexus, calcitonin, bos taurus frontal lobe, sus scrofa frontal lobe, bos taurus hip joint, sus scrofa hip joint, bos taurus hippocampus, sus scrofa hippocampus, bos taurus hypothalamus, sus scrofa hypothalamus, mecasermin rinfabate SPRAY ORAL 20120326 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; BEEF; BOS TAURUS ANKLE JOINT; BOS TAURUS FRONTAL LOBE; BOS TAURUS HIP JOINT; BOS TAURUS HIPPOCAMPUS; BOS TAURUS HYPOTHALAMUS; BOS TAURUS JOINT CAPSULE; BOS TAURUS NERVE; BOS TAURUS SOLAR PLEXUS; BOS TAURUS SPINAL CORD; BOS TAURUS SYMPATHETIC NERVE; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; CALCITONIN; ERSOFERMIN; INTERLEUKIN-10; MECASERMIN RINFABATE; METENKEFALIN; PORK; SUS SCROFA ANKLE JOINT; SUS SCROFA FRONTAL LOBE; SUS SCROFA HIP JOINT; SUS SCROFA HIPPOCAMPUS; SUS SCROFA HYPOTHALAMUS; SUS SCROFA JOINT CAPSULE; SUS SCROFA NERVE; SUS SCROFA SOLAR PLEXUS; SUS SCROFA SPINAL CORD; SUS SCROFA SYMPATHETIC NERVE; TRANSFORMING GROWTH FACTOR BETA-1 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-370_ae7a32eb-16f5-5b56-1c2d-efff17b6ae3b 63776-370 HUMAN OTC DRUG Neuro ingredients SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ABRUS PRECATORIUS SEED; ANTIARIS TOXICARIA RESIN; DOPAMINE; FERROUS ARSENATE; JUNIPERUS SABINA LEAF; LEVODOPA; MELATONIN; RUBIA TINCTORUM WHOLE; SEROTONIN; TAURINE 30; 30; 200; 30; 30; 200; 200; 1; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL 63776-373_e1657f65-47ea-b17f-1965-6b9d176ece33 63776-373 HUMAN OTC DRUG Neuro 3 oxitriptan, acetylcholinesterase human, choline chloride, dopamine, glutamic acid, glycine, histidine, levodopa, malvin, melanin synthetic (tyrosine, peroxide), nitric oxide, norepinephrine, octopamine, water, phenylalanine, serotonin, taurine, tryptophan, tyrosine SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED 5-METHOXYTRYPTAMINE; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; OXITRIPTAN; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 1; 200; 200; 200; 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-385_80f6c44d-e71d-68eb-7954-8b7ad620947f 63776-385 HUMAN OTC DRUG Osteosis bos taurus bone, sus scrofa bone, calcitonin, bos taurus cartilage, sus scrofa cartilage, bos taurus red blood cell, sus scrofa red blood cell, interleukin-3, bos taurus parathyroid gland, sus scrofa parathyroid gland, vitamin d SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED BOS TAURUS BONE; BOS TAURUS CARTILAGE; BOS TAURUS PARATHYROID GLAND; BOS TAURUS RED BLOOD CELL; CALCITONIN; INTERLEUKIN-3; SUS SCROFA BONE; SUS SCROFA CARTILAGE; SUS SCROFA PARATHYROID GLAND; SUS SCROFA RED BLOOD CELL; VITAMIN D 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 30 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-400_63db25bf-30d9-26d2-5993-e885e32b012f 63776-400 HUMAN OTC DRUG Ouch anti-interleukin-1.alpha. immunoglobulin g rabbit, apomorphine, arnica montana, metenkefalin, bryonia alba root, hypericum perforatum, bos taurus hypothalamus, sus scrofa hypothalamus, bos taurus limbic system, sus scrofa limbic system, bos taurus nerve, sus scrofa nerve, bos taurus pituitary gland, sus scrofa pituitary gland SPRAY ORAL 20120326 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; APOMORPHINE; ARNICA MONTANA; BOS TAURUS HYPOTHALAMUS; BOS TAURUS LIMBIC SYSTEM; BOS TAURUS LIMBIC SYSTEM; BOS TAURUS NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM; METENKEFALIN; METENKEFALIN; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LIMBIC SYSTEM; SUS SCROFA LIMBIC SYSTEM; SUS SCROFA NERVE; SUS SCROFA NERVE; SUS SCROFA PITUITARY GLAND 30; 9; 30; 8; 3; 5; 200; 6; 30; 6; 6; 4; 3; 30; 9; 5; 200; 6; 30; 6; 6 [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL 63776-415_21cb2184-e41f-77dc-71ce-bf5d8726c362 63776-415 HUMAN OTC DRUG Parasites wormwood, artemisia cina pre-flowering top, amoeba proteus, fluke, unspecified, oyster shell calcium carbonate, crude, schoenocaulon officinale seed, graphite, iodine, mercuric chloride, melilotus officinalis top, teucrium marum, juglans nigra whole, quassia amara wood, spigelia marilandica root, silicon dioxide SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED AMOEBA PROTEUS; ARTEMISIA CINA PRE-FLOWERING TOP; FLUKE, UNSPECIFIED; GRAPHITE; IODINE; JUGLANS NIGRA WHOLE; MELILOTUS OFFICINALIS TOP; MERCURIC CHLORIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; QUASSIA AMARA WOOD; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SPIGELIA MARILANDICA ROOT; TEUCRIUM MARUM; WORMWOOD 200; 30; 200; 200; 200; 30; 200; 200; 30; 30; 30; 200; 30; 200; 30 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-449_8e0b5bf1-7101-fe74-15a8-d9162b05d0f6 63776-449 HUMAN OTC DRUG Radiation cadmium iodide, fucus vesiculosus, iodine, chondrus crispus, radium bromide, strontium, thyroid, bovine and thyroid, porcine SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED CADMIUM IODIDE; CHONDRUS CRISPUS; FUCUS VESICULOSUS; IODINE; RADIUM BROMIDE; STRONTIUM; THYROID, BOVINE; THYROID, PORCINE 12; 3; 3; 12; 12; 12; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL 63776-450_27a7a5fb-2bf3-e4f9-84ee-e74af7dd285c 63776-450 HUMAN OTC DRUG Relief acetylcholine chloride, prunus cerasifera flower, clematis vitalba flower, histamine, impatiens glandulifera flower, helianthemum nummularium flower, serotonin, ornithogalum umbellatum SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ACETYLCHOLINE CHLORIDE; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; HISTAMINE; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER; SEROTONIN 200; 200; 200; 200; 200; 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-451_485f4fdc-012e-3415-01c9-49300ccb53fc 63776-451 HUMAN OTC DRUG Relief plus G12 acetylcholine chloride, prunus cerasifera flower, clematis vitalba flower, interleukin-12 human, histamine, interleukin-12 human, impatiens glandulifera flower, interferon gamma-1a, helianthemum nummularium flower, serotonin, ornithogalum umbellatum SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ACETYLCHOLINE CHLORIDE; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; HISTAMINE; IMPATIENS GLANDULIFERA FLOWER; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; INTERLEUKIN-12 HUMAN; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER; SEROTONIN 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-453_1c24c293-cb6f-ea1f-836a-e16e7cd6852c 63776-453 HUMAN OTC DRUG Relief 3 acetylcholine chloride, histamine, serotonin SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ACETYLCHOLINE CHLORIDE; HISTAMINE; SEROTONIN 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-454_68d0adc8-9ff0-ff48-213f-92e5e9f7fd89 63776-454 HUMAN OTC DRUG Relief 3-G12 acetylcholine chloride, histamine, interferon gamma-1a, interleukin-12 human, serotonin SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ACETYLCHOLINE CHLORIDE; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; SEROTONIN 200; 200; 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-500_b5736cdb-5ff1-033e-5c86-83881bca30db 63776-500 HUMAN OTC DRUG Systemic Detox bos taurus adrenal gland, sus scrofa adrenal gland, .alpha.-ketoglutaric acid, .alpha.-lipoic acid, ascorbic acid, berberis vulgaris root, activated charcoal, centaurea benedicta, silybum marianum seed, colchicum autumnale bulb, galium aparine, binetrakin, binetrakin, beef kidney, pork kidney, beef liver, pork liver, lycopodium clavatum spore, bos taurus lymph, sus scrofa lymph, bos taurus mesenchyme, sus scrofa mesenchyme, strychnos nux-vomica seed, taraxacum officinale, taraxacum officinale SPRAY ORAL 20120326 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ACTIVATED CHARCOAL; ASCORBIC ACID; BEEF KIDNEY; BEEF LIVER; BERBERIS VULGARIS ROOT; BINETRAKIN; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS THYMUS; BOS TAURUS TONSIL; CENTAUREA BENEDICTA; COLCHICUM AUTUMNALE BULB; GALIUM APARINE; LYCOPODIUM CLAVATUM SPORE; PORK KIDNEY; PORK LIVER; SILYBUM MARIANUM SEED; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA MESENCHYME; SUS SCROFA THYMUS; SUS SCROFA TONSIL; TARAXACUM OFFICINALE; THYROID, BOVINE; THYROID, PORCINE 30; 30; 30; 30; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 6; 30; 6; 200; 200; 30; 200; 30; 200; 200; 200; 200; 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-525_dfc4910a-5a3c-b46b-d362-e36781d219ec 63776-525 HUMAN OTC DRUG Thyro bos taurus adrenal gland, sus scrofa adrenal gland, fucus vesiculosus, iodine, iridium, bos taurus parathyroid gland, sus scrofa parathyroid gland, bos taurus pituitary gland, sus scrofa pituitary gland, bos taurus spleen, sus scrofa spleen, spongia officinalis whole, bos taurus thymus, sus scrofa thymus, thyroid, bovine, thyroid, porcine, levothyroxine, liothyronine SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED BOS TAURUS ADRENAL GLAND; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; FUCUS VESICULOSUS; IODINE; IRIDIUM; LEVOTHYROXINE; LIOTHYRONINE; SPONGIA OFFICINALIS WHOLE; SUS SCROFA ADRENAL GLAND; SUS SCROFA PARATHYROID GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL 63776-605_ada0b104-c65f-11c0-6e6d-75d07d2ccd87 63776-605 HUMAN OTC DRUG Acetaldehyde Acetaldehyde SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ACETALDEHYDE 200 {kp_C}/mL 63776-610_1c70f977-500f-1a21-3c72-c8f2b4c97e64 63776-610 HUMAN OTC DRUG AIL-1 Anti-interleukin-1.alpha. Immunoglobulin G Rabbit SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT 30 {kp_C}/mL 63776-628_1216ca75-85c6-8c62-e09b-1ddd71aadeae 63776-628 HUMAN OTC DRUG BDNF Brain-derived Neurotrophic Factor Human SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN 30 {kp_C}/mL 63776-653_db1428d8-ce9d-b822-0737-6300230da296 63776-653 HUMAN OTC DRUG DHEA Prasterone SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED PRASTERONE 200 {kp_C}/mL 63776-694_b1e7f3a7-2f74-4393-e13c-c9bc539f866b 63776-694 HUMAN OTC DRUG G-12 interleukin-12 human, interferon gamma-1a SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN 200; 200 {kp_C}/mL; {kp_C}/mL 63776-710_e2411cc2-cee2-beff-2f3a-5bb72ccb2023 63776-710 HUMAN OTC DRUG IL-10 Interleukin-10 SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED INTERLEUKIN-10 200 {kp_C}/mL 63777-016_b1f4e04a-24cb-4bb7-b2ae-568e6c319192 63777-016 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part335 Kinray, Inc BISMUTH SUBSALICYLATE 262 mg/15mL 63777-073_507a8328-ee18-4a50-a16a-959e15407a78 63777-073 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Kinray, Inc. LORATADINE 5 mg/5mL 63777-082_e7bfff6a-ae4d-4a6e-9f10-b53edfd198d8 63777-082 HUMAN OTC DRUG Antibiotic and Pain Relief Maximum Strength bacitracin zinc neomycin sulfate polymyxin b sulfate pramoxine hcl OINTMENT TOPICAL 20100701 OTC MONOGRAPH FINAL part333B Kinray, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 63777-098_bacb99e7-454d-4f6b-905b-6a74222477a9 63777-098 HUMAN OTC DRUG Tussin Cough Long Acting Dextromethorphan Hydrobromide LIQUID ORAL 20090209 OTC MONOGRAPH FINAL part341 Kinray DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL 63777-120_6ad4292c-0e91-42d4-a255-3a9a1b1c137e 63777-120 HUMAN OTC DRUG alcohol alcohol SWAB TOPICAL 20111212 OTC MONOGRAPH FINAL part344 Kinray Inc. ISOPROPYL ALCOHOL .7 mL/mL 63777-125_5114328b-ea62-430f-a47f-944f6758a863 63777-125 HUMAN OTC DRUG Infants Ibuprofen concetrated ibuprofen SUSPENSION ORAL 20100701 ANDA ANDA079058 Kinray, Inc. IBUPROFEN 50 mg/1.25mL 63777-130_61fe1ae1-9e3a-459e-bb91-439989bb4ec0 63777-130 HUMAN OTC DRUG Childrens Plus Cough and Runny Nose Acetaminophen, Chlorpheniramine Maleate, DEXTROMETHORPHAN HYDROBROMIDE SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part341 Kinray, Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL 63777-145_96b5fdf7-752d-4a82-a05e-9ed9422f4d37 63777-145 HUMAN OTC DRUG Childrens Plus Multi-Symptom with PE Acetominophen, Chlorphenramine Maleate, Dextrmethrophan Hydrobromide SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part341 Kinray, Inc ACETAMINOPHEN; CHLORPHENIRAMINE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 1; 1 mg/5mL; mg/5mL; mg/5mL; mg/5mL 63777-164_c8c63de1-b054-4ee1-818e-90691664eed1 63777-164 HUMAN OTC DRUG Sore Throat Cherry Phenol LIQUID ORAL 20090801 OTC MONOGRAPH NOT FINAL part356 Kinray, Inc PHENOL 1.5 g/100mL 63777-165_6a9e9549-b651-48f3-85aa-8cbf7e6ed054 63777-165 HUMAN OTC DRUG Sore Throat Menthol Phenol LIQUID ORAL 20090801 OTC MONOGRAPH NOT FINAL part356 Kinray, Inc PHENOL 1.5 g/100mL 63777-204_1005d245-04bf-485a-b32c-847ea123fa3b 63777-204 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate crystal GRANULE ORAL; TOPICAL 20120614 OTC MONOGRAPH NOT FINAL part334 Kinray, Inc. MAGNESIUM SULFATE 1.81 kg/100kg 63777-204_d57f4bac-2988-479b-87df-cabd81151706 63777-204 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate crystal GRANULE ORAL; TOPICAL 20120614 OTC MONOGRAPH NOT FINAL part334 Kinray, Inc. MAGNESIUM SULFATE 1.81 kg/100kg 63777-207_9da4ae15-4064-4067-995c-7164b025c77a 63777-207 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090821 OTC MONOGRAPH FINAL part333 Kinray Inc ISOPROPYL ALCOHOL 70 mL/100mL 63777-209_0da931e1-a314-41bb-b789-b0969aee2ead 63777-209 HUMAN OTC DRUG Witch Hazel Witch Hazel OIL ORAL; TOPICAL 20101108 OTC MONOGRAPH FINAL part346 Kinray Inc WITCH HAZEL 86 mL/100mL 63777-214_3e08c799-1d28-47eb-a30c-e06e6678220f 63777-214 HUMAN OTC DRUG Kinray Vitamin A D Petrolatum OINTMENT TOPICAL 20100419 OTC MONOGRAPH FINAL part347 Kinray Inc. PETROLATUM .76 g/g 63777-214_8bf65991-15d5-4649-a1e0-bf101945961d 63777-214 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090702 OTC MONOGRAPH NOT FINAL part356 Kinray HYDROGEN PEROXIDE 2.65 mL/100mL 63777-217_3e9027ac-cfdd-448b-a8e3-9f9f48babd81 63777-217 HUMAN OTC DRUG bacitracin zinc, neomycin sulfate and polymyxin b sulfate bacitracin zinc, neomycin sulfate and polymyxin b sulfate OINTMENT TOPICAL 20100415 OTC MONOGRAPH FINAL part333B Kinray Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 63777-221_fb347e36-d2e2-42d0-a973-13e37994d5c4 63777-221 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20100908 OTC MONOGRAPH NOT FINAL part333A Kinray Inc ISOPROPYL ALCOHOL 70 mL/100mL 63777-222_9d4c0af2-75b3-44a8-9f9d-da6758e04b0b 63777-222 HUMAN OTC DRUG Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20100419 OTC MONOGRAPH FINAL part347 Kinray Inc. ZINC OXIDE 200 mg/g 63777-223_633e4025-5c13-40b9-ba80-8f7ce9dfd482 63777-223 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120614 OTC MONOGRAPH FINAL part344 Kinray, Inc. ISOPROPYL ALCOHOL 91 mL/100mL 63777-224_5636c3e2-63a0-4d18-beb7-367914b048c0 63777-224 HUMAN OTC DRUG HYDROCORTISONE ACETATE Hydrocortisone Acetate CREAM TOPICAL 20110729 OTC MONOGRAPH NOT FINAL part348 Kinray Inc. HYDROCORTISONE ACETATE 1 g/100g 63777-231_882cf156-b1e4-4ab4-93c6-8c3423193230 63777-231 HUMAN OTC DRUG CLOTRIMAZOLE CLOTRIMAZOLE CREAM TOPICAL 20120111 OTC MONOGRAPH FINAL part333C Kinray Inc. CLOTRIMAZOLE 1 g/100g 63777-247_3cb87c49-75f4-4fe4-a9db-ad82edda0f69 63777-247 HUMAN OTC DRUG HYDROCORTISONE ACETATE Hydrocortisone Acetate OINTMENT TOPICAL 20110906 OTC MONOGRAPH NOT FINAL part348 Kinray Inc. HYDROCORTISONE ACETATE 1 g/100g 63777-255_9d381642-95a3-4993-9b23-ce13651b2453 63777-255 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Kinray Inc. IBUPROFEN 100 mg/5mL 63777-261_9d381642-95a3-4993-9b23-ce13651b2453 63777-261 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Kinray Inc. IBUPROFEN 100 mg/5mL 63777-262_9d381642-95a3-4993-9b23-ce13651b2453 63777-262 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Kinray Inc. IBUPROFEN 100 mg/5mL 63777-263_9d381642-95a3-4993-9b23-ce13651b2453 63777-263 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Kinray Inc. IBUPROFEN 100 mg/5mL 63777-308_57c4efef-764c-40f9-8acf-59b0e40225f5 63777-308 HUMAN OTC DRUG Wintergreen Isopropyl Alcohol Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20090723 OTC MONOGRAPH FINAL part333 Kinray Inc ISOPROPYL ALCOHOL 70 mL/100mL 63777-314_42a3f711-d157-45f7-80f2-0b553ba23652 63777-314 HUMAN OTC DRUG Magnesium Citrate Magnesium Citrate LIQUID ORAL 20110915 OTC MONOGRAPH NOT FINAL part334 Kinray Inc MAGNESIUM CITRATE 2.65 mL/100mL 63777-314_d6f345f9-24a1-4ddf-9948-09bf2a08fa6e 63777-314 HUMAN OTC DRUG Magnesium Citrate Magnesium Citrate LIQUID ORAL 20090320 OTC MONOGRAPH NOT FINAL part334 Kinray Inc MAGNESIUM CITRATE 2.65 mL/100mL 63777-360_ee697316-06a8-482e-8721-896a45b70a0c 63777-360 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20091005 OTC MONOGRAPH NOT FINAL part334 Kinray Inc. MINERAL OIL 15 mL/15mL 63777-414_0302866f-3ebc-40ce-90cb-c13e2f0bd515 63777-414 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090813 OTC MONOGRAPH NOT FINAL part356 Kinray Inc HYDROGEN PEROXIDE 2.65 mL/100mL 63777-414_72d26499-18bb-458a-a0de-d9de163437fb 63777-414 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090209 OTC MONOGRAPH NOT FINAL part356 Kinray Inc HYDROGEN PEROXIDE 2.65 mL/100mL 63777-524_b9a4e58b-e8f2-4f24-8c5a-55d62f5f06c4 63777-524 HUMAN OTC DRUG Lice Treatment permethrin LOTION TOPICAL 20100328 ANDA ANDA075014 Kinray, Inc. PERMETHRIN 1 mg/100mL 63777-805_3147df32-d51b-4ef3-a587-2556889cf23e 63777-805 HUMAN OTC DRUG PREFERRED PLUS PHARMACY 70% ISOPROPYL ALCOHOL WIPES ISOPROPYL ALCOHOL SWAB TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333A Kinray Inc. ISOPROPYL ALCOHOL 700 mg/mL 63777-806_1fcf1391-a95b-4307-b989-709be2ae7374 63777-806 HUMAN OTC DRUG Preferred Plus Pharmacy 3 percent Hydrogen Peroxide Wipes HYDROGEN PEROXIDE SWAB TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333A Kinray Inc. HYDROGEN PEROXIDE 30 mg/mL 63779-056_75d49f4b-545e-43a0-a4ab-eea93723178e 63779-056 HUMAN OTC DRUG Husky Instant Hand Sanitizer Husky Instant Hand Sanitizer SOLUTION TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part333A Canberra Corporation ALCOHOL 62 mL/100mL 63779-340_dbbb387f-137a-43a6-a24e-5458b382b5e3 63779-340 HUMAN OTC DRUG Husky 575 Foaming Antiseptic Hand Cleaner Foaming Antiseptic Hand Cleaner SOLUTION TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part333A Canberra Corporation TRICLOSAN 20.8 g/100mL 63779-505_369a14d0-8977-471f-9e09-6b07a0e49a8c 63779-505 HUMAN OTC DRUG HUSKY 505 Antiseptic Cleanser chloroxylenol LOTION TOPICAL 19981028 OTC MONOGRAPH NOT FINAL part333 Canberra Corporation CHLOROXYLENOL 10.22 g/1000mL 63779-510_2cc0e50c-8dc2-4005-a852-35c3c52448fa 63779-510 HUMAN OTC DRUG HUSKY 510 Anti-Microbial Food Service Hand Cleaner chloroxylenol LIQUID TOPICAL 19981028 OTC MONOGRAPH NOT FINAL part333E Canberra Corporation CHLOROXYLENOL 15.75 g/1000mL 63779-514_18e58373-40c4-4b4c-b868-a18eadf96e52 63779-514 HUMAN OTC DRUG HUSKY 514 Non-Alcohol Foaming Instant Hand Sanitizer Husky 514 SOLUTION TOPICAL 20091116 OTC MONOGRAPH NOT FINAL part333 Canberra Corporation BENZALKONIUM CHLORIDE 1 g/1000mL 63779-515_0206e7a2-15db-4d8c-bccf-f4e096b791cb 63779-515 HUMAN OTC DRUG HUSKY 515 Instant Hand Sanitizer ethanol GEL TOPICAL 19981028 OTC MONOGRAPH NOT FINAL part333E Canberra Corporation ALCOHOL 600 mL/L 63779-575_e2b15f71-1e47-44fd-8b05-e85222f3417a 63779-575 HUMAN OTC DRUG HUSKY 575 Foaming Antiseptic Hand Cleaner triclosan LIQUID TOPICAL 20101011 OTC MONOGRAPH NOT FINAL part333E Canberra Corporation TRICLOSAN 3.15 g/1000mL 63783-005_17b68de7-da38-40b2-9c30-5f46f9ef4aad 63783-005 HUMAN PRESCRIPTION DRUG KIDS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .45103 g/120g 63783-006_17b68de7-da38-40b2-9c30-5f46f9ef4aad 63783-006 HUMAN PRESCRIPTION DRUG KIDS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .451 g/120g 63783-007_17b68de7-da38-40b2-9c30-5f46f9ef4aad 63783-007 HUMAN PRESCRIPTION DRUG KIDS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .451 g/120g 63783-008_17b68de7-da38-40b2-9c30-5f46f9ef4aad 63783-008 HUMAN PRESCRIPTION DRUG KIDS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .451 g/120g 63783-009_17b68de7-da38-40b2-9c30-5f46f9ef4aad 63783-009 HUMAN PRESCRIPTION DRUG KIDS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .451 g/120g 63783-011_f670854b-a91c-4a25-8126-c44ea8a0d816 63783-011 HUMAN PRESCRIPTION DRUG DOCTORS CHOICE STANOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .45103 g/120g 63783-012_f670854b-a91c-4a25-8126-c44ea8a0d816 63783-012 HUMAN PRESCRIPTION DRUG DOCTORS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .451 g/120g 63783-013_f670854b-a91c-4a25-8126-c44ea8a0d816 63783-013 HUMAN PRESCRIPTION DRUG DOCTORS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .451 g/120g 63783-015_17b68de7-da38-40b2-9c30-5f46f9ef4aad 63783-015 HUMAN PRESCRIPTION DRUG KIDS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .451 g/120g 63783-016_f670854b-a91c-4a25-8126-c44ea8a0d816 63783-016 HUMAN PRESCRIPTION DRUG DOCTORS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .451 g/120g 63783-210_06e0288a-15ca-41cb-bc16-96a6e8e93d85 63783-210 HUMAN PRESCRIPTION DRUG GINGIMED STANNOUS FLUORIDE LIQUID ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .71034 g/120g 63783-211_06e0288a-15ca-41cb-bc16-96a6e8e93d85 63783-211 HUMAN PRESCRIPTION DRUG GINGIMED STANNOUS FLUORIDE LIQUID ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .71034 g/120g 63783-212_06e0288a-15ca-41cb-bc16-96a6e8e93d85 63783-212 HUMAN PRESCRIPTION DRUG GINGIMED STANNOUS FLUORIDE LIQUID ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .71034 g/120g 63783-400_270d4955-1afa-42ed-a3b1-9217973b60d7 63783-400 HUMAN PRESCRIPTION DRUG ORTHO GUARD SODIUM FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals SODIUM FLUORIDE .044 mL/100mL 63783-401_270d4955-1afa-42ed-a3b1-9217973b60d7 63783-401 HUMAN PRESCRIPTION DRUG ORTHO GUARD SODIUM FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals SODIUM FLUORIDE .044 mL/100mL 63783-402_270d4955-1afa-42ed-a3b1-9217973b60d7 63783-402 HUMAN PRESCRIPTION DRUG ORTHO GUARD SODIUM FLUORIDE GEL, DENTIFRICE ORAL 19980101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals SODIUM FLUORIDE .044 mL/100mL 63783-403_270d4955-1afa-42ed-a3b1-9217973b60d7 63783-403 HUMAN PRESCRIPTION DRUG ORTHO GUARD SODIUM FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals SODIUM FLUORIDE .044 mL/100mL 63783-500_8c9517c6-e5fa-4989-bf1a-388a219ed9cf 63783-500 HUMAN PRESCRIPTION DRUG NEUTRAMAXX 5000 PLUS TURBO SODIUM FLUORIDE PASTE ORAL 20110901 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals SODIUM FLUORIDE 1.1 g/112g 63783-501_08bc3e50-ef49-49ce-878d-04ae908d2a96 63783-501 HUMAN PRESCRIPTION DRUG NEUTRAMAXX 5000 TCP SODIUM FLUORIDE PASTE, DENTIFRICE ORAL 20110801 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals SODIUM FLUORIDE 1.1 g/112g 63783-504_b83f40be-0407-4612-8e31-7ad9429916a2 63783-504 HUMAN PRESCRIPTION DRUG NEUTRA MAXX 5000 SODIUM FLUORIDE GEL ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals SODIUM FLUORIDE 1.428 g/120g 63798-696_12bad274-11f5-43b5-8965-c1fa75fdefbe 63798-696 HUMAN OTC DRUG Scent-A-Way Anti-Perspirant Extended Protection Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20110810 OTC MONOGRAPH FINAL part350 Hunter's Specialties ALUMINUM ZIRCONIUM 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OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL 63824-015_c5f91cbe-32d9-4168-a56d-f0c2e4826686 63824-015 HUMAN OTC DRUG Mucinex Fast-Max Cold, Flu and Sore Throat acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride SOLUTION ORAL 20120207 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL 63824-016_5495be85-05e7-46c7-bccf-c55f6d9d9414 63824-016 HUMAN OTC DRUG Mucinex Fast-Max Cold and Sinus Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride LIQUID ORAL 20120515 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL 63824-017_c9f88177-76a5-45f5-9dbb-1fd13aba2b94 63824-017 HUMAN OTC DRUG Childrens Mucinex Multi-Symptom Cold and Fever acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride SOLUTION ORAL 20110404 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL 63824-018_ac7c2a92-d8d9-4598-a392-9bcaca0683e9 63824-018 HUMAN OTC DRUG Mucinex Fast-Max DM Max dextromethorphan hydrobromide and guaifenesin SOLUTION ORAL 20120327 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL 63824-019_e15f33de-15f9-4c46-84f0-89bebc0c6790 63824-019 HUMAN OTC DRUG Mucinex Fast-Max DM Max dextromethorphan hydrobromide and guaifenesin SOLUTION ORAL 20120718 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL 63824-020_17c0981b-df8a-4b97-a65f-25cdff251879 63824-020 HUMAN OTC DRUG Mucinex Fast-Max Severe Cold 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OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL 63824-123_f3500817-50d2-4b84-afd7-9cbeaf872dc5 63824-123 HUMAN OTC DRUG Mucinex Full Force OXYMETAZOLINE HYDROCHLORIDE SOLUTION NASAL 20111020 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 63824-124_1222684a-d97b-4718-b57e-136ce0a852fb 63824-124 HUMAN OTC DRUG Mucinex Moisture Smart Oxymetazoline Hydrochloride SOLUTION NASAL 20110701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 63824-125_d46ec3e6-c1d6-4952-894f-1ccf25ba54ae 63824-125 HUMAN OTC DRUG Mucinex Full Force Oxymetazoline Hydrochloride SOLUTION NASAL 20110701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 63824-126_c127955e-0264-41ed-a4ec-a9e83d1a27db 63824-126 HUMAN OTC DRUG Mucinex Sinus-Max Moisture Smart Oxymetazoline Hydrochloride SOLUTION NASAL 20120901 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL 63824-127_f146cf58-8b79-4556-aafb-64cda7171c9e 63824-127 HUMAN OTC DRUG Mucinex Sinus-Max Full Force Oxymetazoline Hydrochloride SOLUTION NASAL 20120901 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL 63824-160_350d558e-8f0c-48f5-aa84-21a52d7d7c1d 63824-160 HUMAN OTC DRUG Delsym Cough Relief Plus Soothing Action Dextromethorphan Hydrobromide and Menthol LOZENGE ORAL 20120701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL 5; 5 mg/1; mg/1 63824-161_1d370013-c9fc-401e-9841-4afe29ee5aed 63824-161 HUMAN OTC DRUG Delsym Cough Relief Plus Soothing Action DEXTROMETHORPHAN HYDROBROMIDE and MENTHOL LOZENGE ORAL 20120701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL 5; 5 mg/1; mg/1 63824-163_dab29c43-cfa1-45f4-bdfb-922c39633d99 63824-163 HUMAN OTC DRUG Delsym Cough Plus Soothing Action Dextromethorphan Hydrobromide and Menthol LOZENGE ORAL 20130412 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL 5; 5 mg/1; mg/1 63824-164_c730b29f-b926-40bf-980f-a1a8604bbd2b 63824-164 HUMAN OTC DRUG Delsym Cough Plus Soothing Action Dextromethorphan Hydrobromide and Menthol LOZENGE ORAL 20130412 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL 5; 5 mg/1; mg/1 63824-171_b39a561d-fd39-4258-b90e-f81c41148a73 63824-171 HUMAN OTC DRUG Delsym Dextromethorphan SUSPENSION, EXTENDED RELEASE ORAL 20100504 NDA NDA018658 Reckitt Benckiser LLC DEXTROMETHORPHAN 30 mg/5mL 63824-172_123cad4b-7c26-404c-94a2-c963ee358797 63824-172 HUMAN OTC DRUG Delsym Dextromethorphan SUSPENSION, EXTENDED RELEASE ORAL 20100504 NDA NDA018658 Reckitt Benckiser LLC DEXTROMETHORPHAN 30 mg/5mL 63824-175_b59252fa-46bb-4abf-9f5a-207693c9e949 63824-175 HUMAN OTC DRUG Delsym Dextromethorphan SUSPENSION, EXTENDED RELEASE ORAL 20100504 NDA NDA018658 Reckitt Benckiser LLC DEXTROMETHORPHAN 30 mg/5mL 63824-176_110056a6-a283-47b3-9fc3-c37b92b505de 63824-176 HUMAN OTC DRUG Delsym Dextromethorphan SUSPENSION, EXTENDED RELEASE ORAL 20100504 NDA NDA018658 Reckitt Benckiser LLC DEXTROMETHORPHAN 30 mg/5mL 63824-182_39e02562-e778-4c14-9107-701105088d3c 63824-182 HUMAN OTC DRUG Delsym Night Time Cough and Cold Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate SOLUTION ORAL 20100406 OTC MONOGRAPH FINAL part341 Reckitt Benckiser, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 63824-183_710e2e20-d244-42c8-a579-147970294a92 63824-183 HUMAN OTC DRUG Delsym Night Time Multi Symptom Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride SOLUTION ORAL 20100409 OTC MONOGRAPH FINAL part341 Reckitt Benckiser, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL 63824-184_fe7122f7-55d2-479f-935b-7d4b5d8d31fa 63824-184 HUMAN OTC DRUG Delsym Childrens Night Time Cough and Cold Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride SOLUTION ORAL 20100429 OTC MONOGRAPH FINAL part341 Reckitt Benckiser, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 12.5; 5 mg/5mL; mg/5mL 63824-185_ae922ca7-1c5c-4e9e-b57e-cf9143c10468 63824-185 HUMAN OTC DRUG Delsym Night Time Cough and Cold DIPHENHYDRAMINE HYDROCHLORIDE and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20110701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 63824-186_5db08954-297b-4b8b-89f6-416e5e7d0fe4 63824-186 HUMAN OTC DRUG Delsym Night Time Multi-Symptom ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE LIQUID ORAL 20110701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 63824-187_0ab7b2b8-487e-41d4-9583-c1bdf0dd3535 63824-187 HUMAN OTC DRUG Delsym Childrens Night Time Cough and Cold DIPHENHYDRAMINE HYDROCHLORIDE and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20110810 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DIPHENHYDRAMINE HYDROCHLORIDE; 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DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 63824-193_0851e04b-1a52-4109-a3ee-a410ad32b9f5 63824-193 HUMAN OTC DRUG Mucinex Fast-Max Severe Congestion and Cough Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, COATED ORAL 20130315 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/1; mg/1; mg/1 63824-196_e283caa8-f85e-4e08-a507-6aacc7767897 63824-196 HUMAN OTC DRUG Mucinex Fast-Max Severe Cold Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20130315 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 63824-200_db9a1da2-43c5-4698-a984-aa103b66aeb7 63824-200 HUMAN OTC DRUG Mucinex Sinus-Max Pressure and Pain Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20120723 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; 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DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/20mL; mg/20mL; mg/20mL 63824-212_6bc56752-e913-4977-bf7e-8a3c3c1915b3 63824-212 HUMAN OTC DRUG Childrens Delsym Cough Plus Cold Night Time Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride SOLUTION ORAL 20130318 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/10mL; mg/10mL; mg/10mL 63824-213_3b7a6e9e-7912-44bb-9fab-27639be48075 63824-213 HUMAN OTC DRUG Delsym Cough Plus Chest Congestion DM Dextromethorphan Hydrobromide and Guaifenesin SOLUTION ORAL 20130331 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL 63824-214_40a9cc25-4bfb-4594-ad0c-fa1bb16acf6e 63824-214 HUMAN OTC DRUG Childrens Delsym Cough Plus Chest Congestion DM Dextromethorphan Hydrobromide and Guaifenesin SOLUTION ORAL 20130331 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 63824-215_84d40271-e82c-40c0-8dcc-de0eac5f42b7 63824-215 HUMAN OTC DRUG Delsym Cough Plus Cold Day Time acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride SOLUTION ORAL 20130331 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL 63824-216_8b6a40f2-0ece-4592-b3f0-376832f11d56 63824-216 HUMAN OTC DRUG Childrens Delsym Cough Plus Cold Day Time acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride SOLUTION ORAL 20140401 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL 63824-231_f83c5adc-fee0-47b8-bf37-ebaf10784b1c 63824-231 HUMAN OTC DRUG Mucinex Fast-Max Severe Cold acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20140401 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/1; mg/1; mg/1; mg/1 63824-232_ccede3df-0e5c-422e-83f6-28f3f3c9651c 63824-232 HUMAN OTC DRUG Mucinex Fast-Max Cold, Flu and Sore Throat acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20140401 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/1; mg/1; mg/1; mg/1 63824-233_581c8e98-7c31-4a64-8e5e-b95d13e3b705 63824-233 HUMAN OTC DRUG Mucinex Fast-Max Night Time Cold and Flu Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20140401 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 63824-234_306c46da-8abe-4a9c-b013-d957b59d75b2 63824-234 HUMAN OTC DRUG Mucinex Fast-Max Day Time Severe Cold and Mucinex Fast-Max Night Time Cold and Flu Maximum Strength Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride KIT 20140410 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC 63824-253_51c8fca3-09a4-48e3-a72d-9947db59859d 63824-253 HUMAN OTC DRUG Mucinex for Kids Guaifenesin GRANULE ORAL 20090324 OTC MONOGRAPH FINAL part341 Reckitt Benckiser, Inc. GUAIFENESIN 50 mg/1 63824-254_23bde28d-b51c-4d84-a407-9b11fe6495db 63824-254 HUMAN OTC DRUG Childrens Mucinex Mini-Melts Chest Congestion Guaifenesin GRANULE ORAL 20090324 OTC MONOGRAPH FINAL part341 Reckitt Benckiser GUAIFENESIN 100 mg/1 63824-256_82c00907-3a14-4cec-b914-f85f5bfffbe9 63824-256 HUMAN OTC DRUG Childrens Mucinex Mini-Melts Cough Dextromethorphan Hydrobromide and Guaifenesin GRANULE ORAL 20090324 OTC MONOGRAPH FINAL part341 Reckitt Benckiser DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/1; mg/1 63824-260_8ef8ec9c-10a0-4801-8675-925923df8f6f 63824-260 HUMAN OTC DRUG Mucinex Sinus-Max Pressure and Pain ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20140326 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL 63824-261_8c7abfd5-0a4f-45ac-a5cc-ffe624125330 63824-261 HUMAN OTC DRUG Mucinex Sinus-Max Severe Congestion Relief ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20140326 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL 63824-262_fc2c9f6f-35d2-4156-b1f9-0a2807536957 63824-262 HUMAN OTC DRUG Mucinex Sinus-Max Night Time Congestion and Cough Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride LIQUID ORAL 20140326 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/20mL; mg/20mL; mg/20mL 63824-263_e6a482f6-ac2b-4a99-862f-c8ca74f3e3bf 63824-263 HUMAN OTC DRUG Mucinex Sinus-Max Day Time Severe Congestion Relief and Mucinex Sinus-Max Night Time Congestion and Cough Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride, and Diphenhydramine Hydrochloride KIT 20140428 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC 63824-271_b67d2299-cf86-4efc-9096-3f9273c10c7f 63824-271 HUMAN OTC DRUG Delsym Dextromethorphan SUSPENSION, EXTENDED RELEASE ORAL 20081022 NDA NDA018658 Reckitt Benckiser, Inc. DEXTROMETHORPHAN 30 mg/5mL 63824-273_ab11890b-fe69-4295-9748-2e6328711096 63824-273 HUMAN OTC DRUG Mucinex for Kids Guaifenesin SOLUTION ORAL 20090408 OTC MONOGRAPH FINAL part341 Reckitt Benckiser, Inc. GUAIFENESIN 100 mg/5mL 63824-274_84774456-6a9a-40bb-b1c3-927db9150a2e 63824-274 HUMAN OTC DRUG Childrens Mucinex Cough Guaifenesin and Dextromethorphan Hydrobromide SOLUTION ORAL 20100622 OTC MONOGRAPH FINAL part341 Reckitt Benckiser, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 63824-277_f3afbd43-6437-4b4f-b9ad-9d60ec072eef 63824-277 HUMAN OTC DRUG Childrens Mucinex Stuffy Nose and Cold Guaifenesin and Phenylephrine Hydrochloride SOLUTION ORAL 20120618 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 100; 2.5 mg/5mL; mg/5mL 63824-278_6880d2b6-1650-4a15-9ad0-bbc8c40c8d80 63824-278 HUMAN OTC DRUG Childrens Mucinex Cold, Cough and Sore Throat acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride SOLUTION ORAL 20110419 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL 63824-279_9cc981ec-90aa-4b26-a4e9-76c159691487 63824-279 HUMAN OTC DRUG Childrens Mucinex Congestion and Cough DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE SOLUTION ORAL 20120610 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 63824-280_65cb02de-aa36-4bce-9045-79448592daae 63824-280 HUMAN OTC DRUG Childrens Mucinex Chest Congestion Guaifenesin LIQUID ORAL 20110701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC GUAIFENESIN 100 mg/5mL 63824-281_f55f7917-4250-47d0-9ec7-27f2e2eaae42 63824-281 HUMAN OTC DRUG Childrens Mucinex Cough GUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20110701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 63824-282_9b35842f-c281-475a-a656-a2086ad330d1 63824-282 HUMAN OTC DRUG Childrens Mucinex Multi-Symptom Cold Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride SOLUTION ORAL 20120717 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 63824-283_77db8f72-e186-4b91-9aee-7b57f66451fc 63824-283 HUMAN OTC DRUG Childrens Mucinex Congestion and Cough Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride SOLUTION ORAL 20120717 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 63824-284_742ceaca-0691-4256-9466-8304d40c52ec 63824-284 HUMAN OTC DRUG Childrens Mucinex Stuffy Nose and Cold Guaifenesin and Phenylephrine Hydrochloride SOLUTION ORAL 20120713 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 100; 2.5 mg/5mL; mg/5mL 63824-285_e87179c5-a327-4906-9f65-c071395ff7b0 63824-285 HUMAN OTC DRUG Childrens Mucinex Chest Congestion Guaifenesin SOLUTION ORAL 20120713 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC GUAIFENESIN 100 mg/5mL 63824-286_0cbf7d3c-12a0-45c3-8239-432e6ffda349 63824-286 HUMAN OTC DRUG Childrens Mucinex Cough Dextromethorphan Hydrobromide and Guaifenesin SOLUTION ORAL 20120713 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL 63824-287_c05896da-99d3-4efd-a515-2055d1d159f8 63824-287 HUMAN OTC DRUG Childrens Mucinex Multi Symptom Cold and Childrens Mucinex Night Time Multi Symptom Cold Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride KIT 20140401 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC 63824-301_a42613d8-61b5-4322-a42a-b8790f91aa52 63824-301 HUMAN OTC DRUG Clearasil Daily Clear Tinted Adult Treatment Sulfur and Resorcinol CREAM TOPICAL 20100317 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser, Inc. RESORCINOL; SULFUR 2; 8 g/100g; g/100g 63824-302_e879d50e-93a6-4565-8596-63ba177e09b1 63824-302 HUMAN OTC DRUG Clearasil Daily Clear Tinted Acne Treatment Benzoyl Peroxide CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC BENZOYL PEROXIDE 10 g/100g 63824-303_306ed258-1dfb-4b1b-8aff-65c81b7dd6f7 63824-303 HUMAN OTC DRUG Clearasil Daily Clear Vanishing Acne Treatment Benzoyl Peroxide CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC BENZOYL PEROXIDE 10 g/100g 63824-304_5e39f3cf-53e7-423d-bac0-93920a53a617 63824-304 HUMAN OTC DRUG Clearasil Daily Clear Daily Facial Scrub Salicylic Acid LOTION TOPICAL 20120925 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-305_39fb404a-c1b4-4308-aa17-2aa2673130a5 63824-305 HUMAN OTC DRUG Clearasil Ultra Rapid Action Face Scrub Salicylic Acid LOTION TOPICAL 20120925 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-306_822e3327-d4dd-47f3-91e6-173a83e711e9 63824-306 HUMAN OTC DRUG Clearasil Ultra Overnight Wash Salicylic Acid SOLUTION TOPICAL 20120928 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-307_3867e0c5-6fbc-404e-a7b6-8c067119c79f 63824-307 HUMAN OTC DRUG Clearasil Daily Clear Refreshing Superfruit Toner Salicylic Acid SOLUTION TOPICAL 20130601 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 1 g/100mL 63824-309_869a2a2d-6ba8-4e81-a70d-bd5b44e1dd64 63824-309 HUMAN OTC DRUG Clearasil Ultra Rapid Action Vanishing Treatment Benzoyl Peroxide CREAM TOPICAL 20110730 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC BENZOYL PEROXIDE 10 g/100g 63824-310_1f389e78-95c8-4bd9-ab28-2f7dd3de9c51 63824-310 HUMAN OTC DRUG Clearasil Ultra Tinted Rapid Action Treatment Benzoyl Peroxide CREAM TOPICAL 20090804 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser, Inc. BENZOYL PEROXIDE 10 g/100g 63824-313_22d12d95-f897-44c9-a5ae-6fad8552d003 63824-313 HUMAN OTC DRUG Clearasil Daily Clear Adult Tinted Acne Treatment Sulfur and Resorcinol CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC RESORCINOL; SULFUR 2; 8 g/100g; g/100g 63824-314_a3bcc225-f0bc-46ae-a47e-ef4bf3f13ef8 63824-314 HUMAN OTC DRUG Clearasil Ultra Rapid Action Treatment Salicylic Acid LOTION TOPICAL 20131108 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-315_c443a840-5d29-4f80-90a5-8a751b4661bd 63824-315 HUMAN OTC DRUG Clearasil Ultra Daily Face Wash Salicylic Acid SOLUTION TOPICAL 20100818 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser, Inc. SALICYLIC ACID 2 g/100mL 63824-317_ab6dc60e-f50c-44a5-8692-11f818296975 63824-317 HUMAN OTC DRUG Clearasil Daily Clear Hydra-Blast Oil-Free Face Wash Sensitive Salicylic Acid LOTION TOPICAL 20131201 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-318_3d138b80-ddcb-4745-84e6-9511541dafc4 63824-318 HUMAN OTC DRUG Clearasil Ultra Acne Clearing Scrub Salicylic Acid SOLUTION TOPICAL 20090818 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser, Inc. SALICYLIC ACID 2 mg/100mL 63824-319_4b7d3fd1-6cc0-4411-8a3e-0ecd0a739b20 63824-319 HUMAN OTC DRUG Clearasil Daily Clear Hydra-Blast Oil-Free Salicylic Acid GEL TOPICAL 20131201 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-320_81d7ce8f-34ca-4bc6-bafa-a04fc9452c3c 63824-320 HUMAN OTC DRUG Clearasil Daily Clear Hydra-Blast Oil-Free Pads Salicylic Acid SOLUTION TOPICAL 20131201 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID .03 g/1 63824-321_d2a54309-6b42-4ed8-8c24-6be714eff0ab 63824-321 HUMAN OTC DRUG Clearasil Daily Clear Hydra-Blast Oil-Free Face Scrub Salicylic Acid LOTION TOPICAL 20131101 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-322_036485f7-0f28-4ecf-976a-cf948866f1a5 63824-322 HUMAN OTC DRUG Clearasil Ultra 5 in 1 Pads Salicylic Acid SOLUTION TOPICAL 20140901 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID .03 g/1 63824-323_0fb0e0d3-9cdf-4ff6-b85c-8e8cef577df6 63824-323 HUMAN OTC DRUG Clearasil Ultra 5 in 1 Exfoliating Wash Salicylic Acid CREAM TOPICAL 20140901 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 1.9 g/100mL 63824-324_9f30d0f8-defd-403f-966e-8776d2620b4c 63824-324 HUMAN OTC DRUG Clearasil Ultra 5 in 1 Salicylic Acid LOTION TOPICAL 20140901 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 1.9 g/100mL 63824-328_8b2ccbaa-1c99-480b-aab1-0791e7d52ba7 63824-328 HUMAN OTC DRUG Clearasil Ultra Acne Clearing Gel Wash Salicylic Acid SOLUTION TOPICAL 20090820 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser, Inc. SALICYLIC ACID 2 g/100mL 63824-332_2cdba64f-ff5b-472c-be6a-5e264918ca9c 63824-332 HUMAN OTC DRUG Clearasil Daily Clear Skin Perfect Wash Salicylic Acid SOLUTION TOPICAL 20100126 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser, Inc. SALICYLIC ACID 2 g/100mL 63824-333_72ecd72a-362d-453f-828c-6c785494184b 63824-333 HUMAN OTC DRUG Clearasil Daily Clear Oil-Free Daily Wash Salicylic Acid GEL TOPICAL 20120801 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-334_15bce440-5bd3-4b3b-a1a5-1f75a2b9eede 63824-334 HUMAN OTC DRUG Clearasil Daily Clear Daily Pore Cleansing Pads Salicylic Acid SWAB TOPICAL 20110824 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-335_4c27804f-c0f8-4ddb-908f-8540cf6fce16 63824-335 HUMAN OTC DRUG Clearasil Daily Clear Daily Facial Scrub Salicylic Acid LOTION TOPICAL 20120629 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-338_734e6a45-e7cb-4dbc-a375-52e94b13f7f8 63824-338 HUMAN OTC DRUG Clearasil Ultra Overnight Wash Salicylic Acid SOLUTION TOPICAL 20110723 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser, Inc. SALICYLIC ACID 2 g/100mL 63824-339_5c541c78-51a8-45db-8224-d1ff6565225f 63824-339 HUMAN OTC DRUG Clearasil Ultra Overnight Face Salicylic Acid LOTION TOPICAL 20110818 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-340_8aafb76f-11ca-4a75-b89b-dc460f29dc61 63824-340 HUMAN OTC DRUG Clearasil Ultra On-The-Go Rapid Action Wipes Salicylic Acid SOLUTION TOPICAL 20120824 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-341_257f6574-9190-4965-a6d8-b95f8779bd56 63824-341 HUMAN OTC DRUG Clearasil Ultra Rapid Action Treatment Salicylic Acid GEL TOPICAL 20110801 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100g 63824-342_80e1b21d-bdcd-42e4-ad77-6d5efaf52ed8 63824-342 HUMAN OTC DRUG LYSOL Healthy Touch Soothing Cucumber Splash Benzethonium chloride SOLUTION TOPICAL 20110721 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser, LLC BENZETHONIUM CHLORIDE .13 g/100mL 63824-343_5d1d26ac-7e66-433f-9435-a69078bb4a0b 63824-343 HUMAN OTC DRUG LYSOL Healthy Touch Cleansing Green Tea and Ginger Benzethonium chloride SOLUTION TOPICAL 20110721 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser, LLC BENZETHONIUM CHLORIDE .13 g/100mL 63824-344_7463e378-0b2e-440d-be8b-fd834cb02c7d 63824-344 HUMAN OTC DRUG LYSOL Healthy Touch Refreshing Grapefruit Essence Benzethonium chloride SOLUTION TOPICAL 20110721 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser, LLC BENZETHONIUM CHLORIDE .13 g/100mL 63824-345_a3edcf44-145f-4ed0-9de7-2a7367f4b492 63824-345 HUMAN OTC DRUG Clearasil Ultra Rapid Action Pads Salicylic Acid SOLUTION TOPICAL 20111212 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID .03 g/1 63824-346_de2b3f99-bb7e-4e9c-85ec-c04b1c7e9d43 63824-346 HUMAN OTC DRUG Clearasil Ultra Acne plus Marks Wash and Mask Salicylic Acid SOLUTION TOPICAL 20101015 OTC MONOGRAPH FINAL part333D Reckitt Benckiser, Inc. SALICYLIC ACID 2 g/100mL 63824-347_2ae22202-d079-4174-a5b6-84f8b23d6b09 63824-347 HUMAN OTC DRUG Clearasil Ultra Acne Plus Marks Spot Salicylic Acid LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-348_f83d3aaf-1f53-44d6-91ab-55c91a85e6e8 63824-348 HUMAN OTC DRUG LYSOL Healthy Touch Aloe Vera And Vitamin E with Moisturizers Benzethonium chloride SOLUTION TOPICAL 20110721 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZETHONIUM CHLORIDE .13 g/100mL 63824-349_cc0207f5-74f8-4c8d-9adf-e0eb2e32fb17 63824-349 HUMAN OTC DRUG LYSOL Healthy Touch Benzethonium chloride SOLUTION TOPICAL 20110721 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZETHONIUM CHLORIDE .13 g/100mL 63824-350_d93cca69-dbee-40a2-b841-4bafdb19d9fc 63824-350 HUMAN OTC DRUG Clearasil Daily Clear Oil-Free Daily Face Wash Salicylic Acid LOTION TOPICAL 20120624 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-351_8c04eea2-542d-4b6b-92fa-21626911ecbf 63824-351 HUMAN OTC DRUG Clearasil Daily Clear Oil-Free Daily Face Wash Sensitive Formula Salicylic Acid LOTION TOPICAL 20120715 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-352_bbc38780-11e1-4608-8424-21ee3953116b 63824-352 HUMAN OTC DRUG Clearasil Ultra Overnight Scrub Salicylic Acid SOLUTION TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-353_f25e4d81-402c-4f93-b032-4e07085ef97e 63824-353 HUMAN OTC DRUG Clearasil Ultra Rapid Action Seal-to-Clear Salicylic Acid GEL TOPICAL 20110721 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-354_3bb9377a-5902-43d9-8a4d-b354f86eff13 63824-354 HUMAN OTC DRUG Clearasil Ultra Rapid Action Acne System Salicylic Acid and Benzoyl Peroxide KIT 20110101 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC 63824-360_654e0c48-68d0-4822-abb4-6cb5a1d3dc56 63824-360 HUMAN OTC DRUG Clearasil PerfectaWash Ultra Rapid Action Face Wash Refill - Superfruit Splash Salicylic Acid LOTION TOPICAL 20120101 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-361_1f8561c1-1317-4383-9d38-668e6760b0bc 63824-361 HUMAN OTC DRUG Clearasil PerfectaWash Ultra Rapid Action Face Wash Refill - Soothing Plant Extracts Salicylic Acid LOTION TOPICAL 20120101 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-362_eaf06162-705f-4f85-84ba-a0558e4d3989 63824-362 HUMAN OTC DRUG Clearasil Ultra Acne System Salicylic Acid and Benzoyl Peroxide KIT 20120101 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC 63824-380_1d0ef448-31c5-4355-bcef-2d65accaa655 63824-380 HUMAN OTC DRUG Clearasil Ultra Rapid Action Daily Face Wash Salicylic Acid LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-381_497ecf3f-da80-42e8-8485-64db6ea5d6da 63824-381 HUMAN OTC DRUG Clearasil Ultra Rapid Action Daily Wash Salicylic Acid GEL TOPICAL 20120721 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-385_7370b9df-4386-4445-a97b-14b8904724ea 63824-385 HUMAN OTC DRUG Clearasil Ultra Rapid Action Face Scrub Salicylic Acid LOTION TOPICAL 20120629 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-390_c894a5a1-9926-4220-a330-018491686cba 63824-390 HUMAN OTC DRUG Clearasil Ultra Acne plus Marks Wash and Mask Salicylic Acid LOTION TOPICAL 20110915 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-395_7e0bea5f-a297-478a-99ec-fce4df7ed9da 63824-395 HUMAN OTC DRUG Clearasil Ultra Acne Plus Marks Daily Scrub Salicylic Acid LOTION TOPICAL 20120504 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 150 mL/mL 63824-400_7090ba4e-b4ba-403f-a62c-fc733335e0ce 63824-400 HUMAN OTC DRUG Clearasil Daily Clear Refreshing Superfruit Pads Salicylic Acid SOLUTION TOPICAL 20130311 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID .015 g/1 63824-401_3ffd743d-6860-4070-8557-f0ed5e43a09a 63824-401 HUMAN OTC DRUG Clearasil Daily Clear Refreshing Superfruit Wash Salicylic Acid SOLUTION TOPICAL 20130311 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 1 g/100mL 63824-402_849297ee-9cb6-4dd7-b250-205c9d6979fc 63824-402 HUMAN OTC DRUG Clearasil Daily Clear Refreshing Superfruit Scrub Salicylic Acid LOTION TOPICAL 20130311 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 1 g/100mL 63824-410_115370ee-d7ed-422d-96e6-fb3d94fa19c2 63824-410 HUMAN OTC DRUG Clearasil PerfectaWash Ultra Rapid Action Face Wash Dispenser and Refills Salicylic Acid KIT 20120101 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC 63824-411_e817de30-7035-4d47-9d3c-9adc22f5edc6 63824-411 HUMAN OTC DRUG Clearasil PerfectaWash Ultra Rapid Action Face Wash Dispenser and Refills Salicylic Acid KIT 20120501 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC 63824-412_d4fa3e36-6412-4f8f-b017-cc133b1e8628 63824-412 HUMAN OTC DRUG Clearasil Daily Clear Oil-Free Daily Face Wash Salicylic Acid LOTION TOPICAL 20130408 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-413_8de0391f-3844-4e63-9132-7455da9a3ade 63824-413 HUMAN OTC DRUG Clearasil Daily Clear Oil-Free Daily Face Wash Sensitive Salicylic Acid LOTION TOPICAL 20130408 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-414_d93ddb0c-24ae-40eb-8ba1-45a3c84ca325 63824-414 HUMAN OTC DRUG Clearasil Ultra Fast Fix Acne Salicylic Acid and Benzoyl Peroxide KIT 20131101 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC 63824-415_cd1e33a7-ba11-4ad6-9a87-fd1a068fb7ad 63824-415 HUMAN OTC DRUG Clearasil Ultra Rapid Action Face Wash Salicylic Acid LOTION TOPICAL 20131201 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-416_feefead0-80c2-43d0-9882-02fae6d66880 63824-416 HUMAN OTC DRUG Clearasil Ultra Rapid Action Scrub Salicylic Acid LOTION TOPICAL 20131201 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-417_91c4f4ef-ea4d-4408-ab1c-cc42655d5837 63824-417 HUMAN OTC DRUG Clearasil Daily Clear Hydra-Blast Oil-Free Face Scrub Salicylic Acid LOTION TOPICAL 20131201 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-420_1a03b4ac-894e-4335-9ab1-5b07e97a7ac1 63824-420 HUMAN OTC DRUG Clearasil Ultra Acne Plus Marks Daily Scrub Salicylic Acid LOTION TOPICAL 20141222 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL 63824-450_f3b4b947-4e09-4291-b184-fa03f1f74511 63824-450 HUMAN OTC DRUG Lysol No Touch Benzethonium chloride SOLUTION TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZETHONIUM CHLORIDE .13 g/100mL 63824-451_c4dcb4da-c886-4ecd-a183-4e189b45e441 63824-451 HUMAN OTC DRUG Lysol No Touch Benzethonium chloride SOLUTION TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZETHONIUM CHLORIDE .13 g/100mL 63824-452_613768ff-756a-41c4-82c4-ad2f5637703d 63824-452 HUMAN OTC DRUG Lysol No Touch Benzethonium chloride SOLUTION TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZETHONIUM CHLORIDE .13 g/100mL 63824-453_7241da62-f29f-41a3-8ac0-1d8eaef31443 63824-453 HUMAN OTC DRUG Lysol No Touch Benzalkonium Chloride SOLUTION TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL 63824-455_d8454c9c-3a21-469a-acc6-9d8c70d1048a 63824-455 HUMAN OTC DRUG Lysol No Touch Benzalkonium Chloride SOLUTION TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL 63824-456_b917f796-d3c3-4a5f-bbeb-0f21faa4ab9a 63824-456 HUMAN OTC DRUG Lysol No Touch Benzalkonium Chloride SOLUTION TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL 63824-458_75f1170c-5b0d-42e7-8b09-88d3ee01ddc2 63824-458 HUMAN OTC DRUG Lysol No Touch Triclosan SOLUTION TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC TRICLOSAN .1 g/100mL 63824-459_3eac17a8-ccd9-42b2-9b4b-ca9f26b7bab1 63824-459 HUMAN OTC DRUG Lysol No Touch Triclosan SOLUTION TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC TRICLOSAN .1 g/100mL 63824-460_7d8a0e20-fc00-4092-8dfc-45aef4c05314 63824-460 HUMAN OTC DRUG Lysol No Touch Triclosan SOLUTION TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC TRICLOSAN .1 g/100mL 63824-461_cb08fcf2-6e79-4dee-992a-977c7a808b08 63824-461 HUMAN OTC DRUG Lysol No Touch Benzethonium chloride SOLUTION TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZETHONIUM CHLORIDE .13 g/100mL 63824-462_fa27b0aa-6ac2-4437-be75-e85a3930f673 63824-462 HUMAN OTC DRUG Lysol No Touch Benzethonium chloride SOLUTION TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZETHONIUM CHLORIDE .13 g/100mL 63824-464_b0cf56a7-9544-41cf-b1f6-b81034d4ec37 63824-464 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride SOLUTION TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL 63824-465_cc9c6315-7e29-4266-baf9-74bbde06da75 63824-465 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride SOLUTION TOPICAL 20121226 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL 63824-466_1ce118f9-4bc9-4c93-9d3c-f840cea63af8 63824-466 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride SOLUTION TOPICAL 20121226 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL 63824-467_8e10e398-bfe7-46ee-a1b0-530ecff5671a 63824-467 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride SOLUTION TOPICAL 20121226 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL 63824-468_79f5a916-f629-4dd7-ad54-7f313fb87d3f 63824-468 HUMAN OTC DRUG Lysol No Touch Triclosan SOLUTION TOPICAL 20121230 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC TRICLOSAN .1 g/100mL 63824-469_082d95f9-15e3-42bf-a017-861cc36d4690 63824-469 HUMAN OTC DRUG Lysol No Touch Triclosan SOLUTION TOPICAL 20121230 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC TRICLOSAN .1 g/100mL 63824-470_8552ba10-92c7-4199-ab07-8cfde5204c01 63824-470 HUMAN OTC DRUG Lysol No Touch Triclosan SOLUTION TOPICAL 20121230 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC TRICLOSAN .1 g/100mL 63824-471_859d989e-ca72-4e21-8360-fc17402b43f8 63824-471 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride SOLUTION TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL 63824-472_ec254469-6a29-465b-a470-efe0b911f983 63824-472 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride SOLUTION TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL 63824-473_74995139-de15-48d7-9824-554f8dc0f9c1 63824-473 HUMAN OTC DRUG Childrens Mucinex Chest Congestion Guaifenesin SOLUTION ORAL 20100622 OTC MONOGRAPH FINAL part341 Reckitt Benckiser, Inc. GUAIFENESIN 100 mg/5mL 63824-474_949f3427-360f-49b3-879e-e32520ff97e6 63824-474 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride SOLUTION TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL 63824-475_16fc64ef-e0cc-4bf8-b375-5ab3a8a0abac 63824-475 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride SOLUTION TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL 63824-476_f2e71ff1-f057-4e01-b2a2-72e07f0a78b5 63824-476 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride SOLUTION TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL 63824-477_6cf5d57f-fa19-4e68-93e2-4f1a19f181ef 63824-477 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride KIT 20130123 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC 63824-478_81b449c5-d12a-4269-b632-33d64a0bc1bc 63824-478 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride KIT 20130123 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC 63824-479_c953a899-9e3c-48e8-9cf1-4eea4b9e6d1e 63824-479 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride SOLUTION TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL 63824-480_e6ab0188-1881-4299-a320-3746172852dc 63824-480 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride SOLUTION TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL 63824-481_05e86019-0d7b-41a5-b9fe-f5ee08adcded 63824-481 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride SOLUTION TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL 63824-482_75a2d0ba-f5f0-46c3-af46-d59f07ae8c24 63824-482 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride SOLUTION TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL 63824-499_21ec0eff-5f3b-4a7d-aa3b-7fe53887a3c6 63824-499 HUMAN OTC DRUG Lysol I.C. Antimicrobial Triclosan SOLUTION TOPICAL 20041231 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC TRICLOSAN .3 g/100mL 63824-500_43357cc5-96b6-455a-9357-56f632a6e6e5 63824-500 HUMAN OTC DRUG Mucinex Fast-Max Night Time Cold and Flu Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride SOLUTION ORAL 20130315 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/20mL; mg/20mL; mg/20mL 63824-526_839cef10-acb1-4902-9cb2-c7806bf2cdeb 63824-526 HUMAN OTC DRUG Mucinex Fast-Max Day Time Severe Cold and Mucinex Fast-Max Night Time Cold and Flu Maximum Strength Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride KIT 20130411 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC 63824-528_ecb8544b-0ab2-445a-9c59-7ddaee3fc52c 63824-528 HUMAN OTC DRUG Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu Maximum Strength Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride KIT 20140509 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC 63824-550_ee0a8929-02f0-44ef-87d6-c7054257978b 63824-550 HUMAN OTC DRUG Mucinex Fast-Max Night Time Cold and Flu Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20130430 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 63824-551_8833b91f-f4bd-4d85-9395-579d29afbc91 63824-551 HUMAN OTC DRUG Mucinex Fast-Max Day Time Severe Cold and Mucinex Fast-Max Night Time Cold and Flu Maximum Strength Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride KIT 20130501 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC 63824-555_a3ab97d4-dfe6-429d-8735-6e64d9f015c4 63824-555 HUMAN OTC DRUG Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu Maximum Strength Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Acetaminophen, and Diphenhydramine Hydrochloride KIT 20140425 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC 63824-600_b1e33b78-2cfd-4b83-86d8-090b90d5a7d8 63824-600 HUMAN OTC DRUG Childrens Mucinex Night Time Multi-Symptom Cold Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride SOLUTION ORAL 20130325 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/10mL; mg/10mL; mg/10mL 63824-710_ac588063-63fe-4fa3-949b-6de0eb2d32db 63824-710 HUMAN OTC DRUG Cepacol Sore Throat Benzocaine and Menthol LOZENGE ORAL 20110804 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 63824-711_4d59266b-2bb2-411d-bec4-107b3008a06e 63824-711 HUMAN OTC DRUG Cepacol Sore Throat Benzocaine and Menthol LOZENGE ORAL 20120528 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 63824-712_2fb17506-fc19-4103-90d8-a9bf0d890645 63824-712 HUMAN OTC DRUG Cepacol Sore Throat Benzocaine and Menthol LOZENGE ORAL 20130315 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 63824-713_717df460-9517-4bbe-bd14-ef192ae72c96 63824-713 HUMAN OTC DRUG Cepacol Extra Strength Sore Throat cherry Benzocaine and Menthol LOZENGE ORAL 20130715 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC BENZOCAINE; 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PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 63824-916_a2e9a7d2-9785-4145-9a3b-50ef08295afc 63824-916 HUMAN OTC DRUG Lice MD Complete Pyrethrum Extract and Piperonyl Butoxide KIT 20121101 OTC MONOGRAPH FINAL part358G Reckitt Benckiser LLC 63824-926_b87ef385-cbb8-41ae-9cef-e4bf9af038f4 63824-926 HUMAN OTC DRUG Mucinex Allergy Fexofenadine Hydrochloride TABLET ORAL 20140102 ANDA ANDA076502 Reckitt Benckiser LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 63830-221_ba3d00b4-7f0a-4c97-9cbe-9df9150370fa 63830-221 HUMAN OTC DRUG Sani-Care ALCOHOL GEL TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part333E Pro Chem, Inc. ALCOHOL .7 mL/mL 63830-544_39de0d4a-75e6-4023-b3f6-1627bd3e6eb8 63830-544 HUMAN OTC DRUG Ban-Aid CHLOROXYLENOL SOAP TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part333E Pro Chem, Inc. CHLOROXYLENOL 3 mg/mL 63830-585_b7297bc8-31de-44dd-978e-893af63a1b4a 63830-585 HUMAN OTC DRUG Prevent ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333 Pro Chem, Incorporated ALCOHOL .7 mL/mL 63830-855_7d5f6cd9-716b-4201-9a18-3dafc2ce4b52 63830-855 HUMAN OTC DRUG Prevent ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333E Pro Chem, Incorporated ALCOHOL .62 mL/mL 63833-386_1d1503c9-6563-4725-b90d-931151c75851 63833-386 PLASMA DERIVATIVE Kcentra PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, Protein C, Protein S Human, and Water KIT 20130429 BLA BLA125421 CSL Behring GmbH 63833-387_1d1503c9-6563-4725-b90d-931151c75851 63833-387 PLASMA DERIVATIVE Kcentra PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, Protein C, Protein S Human, and Water KIT 20131213 BLA BLA125421 CSL Behring GmbH 63833-518_3ddc230a-749c-4774-acf2-6bc7ea5e7f20 63833-518 PLASMA DERIVATIVE Corifact Factor XIII Concentrate (Human) KIT 20110217 BLA BLA125385 CSL Behring GmbH 63833-615_b23ec17c-4698-4a11-841e-eb620dce703b 63833-615 PLASMA DERIVATIVE Humate-P antihemophilic factor/von willebrand factor complex (human) KIT 19860501 BLA BLA103960 CSL Behring GmbH 63833-616_b23ec17c-4698-4a11-841e-eb620dce703b 63833-616 PLASMA DERIVATIVE Humate-P antihemophilic factor/von willebrand factor complex (human) KIT 19860501 BLA BLA103960 CSL Behring GmbH 63833-617_b23ec17c-4698-4a11-841e-eb620dce703b 63833-617 PLASMA DERIVATIVE Humate-P antihemophilic factor/von willebrand factor complex (human) KIT 19860501 BLA BLA103960 CSL Behring GmbH 63833-825_50c8a1af-5fb0-44b2-aa19-dec0badd894f 63833-825 PLASMA DERIVATIVE Berinert HUMAN C1-ESTERASE INHIBITOR KIT 20111222 BLA BLA125287 CSL Behring GmbH 63833-891_93c22ea0-e934-4ac5-92ff-7538f503811f 63833-891 PLASMA DERIVATIVE RiaSTAP Fibrinogen INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090116 BLA BLA125317 CSL Behring GmbH FIBRINOGEN 1300 mg/50mL Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] 63843-465_b909eca4-f8f6-4e01-920f-6360da698ab6 63843-465 HUMAN OTC DRUG FOAMING ALOEGUARD ANTIMICROBIAL CHLOROXYLENOL SOAP TOPICAL 20140623 OTC MONOGRAPH NOT FINAL part333E HealthLink CHLOROXYLENOL 2.5 g/1000mL 63843-487_2ececabf-88d9-470c-b1eb-c923214c7fdd 63843-487 HUMAN OTC DRUG SELECT ANTISEPTIC HAND GEL WITH ALOE ALCOHOL SOAP TOPICAL 20130925 OTC MONOGRAPH NOT FINAL part333E HealthLink ALCOHOL .62 mL/mL 63843-509_dd0fd9cd-30d5-45db-9988-cdf71ee2cd9e 63843-509 HUMAN OTC DRUG ALOEGUARD ANTIMICROBIAL CHLOROXYLENOL SOAP TOPICAL 20130820 OTC MONOGRAPH NOT FINAL part333E HealthLink CHLOROXYLENOL 5 g/1000mL 63843-520_7e0583b1-d09f-4da7-9ffb-6d8b77c58fd1 63843-520 HUMAN OTC DRUG GBG AloeGel Instant Hand Sanitizer Alcohol SOAP TOPICAL 20001001 OTC MONOGRAPH NOT FINAL part333E HealthLink ALCOHOL .62 mL/mL 63843-547_9b0d188f-b17e-4ca1-a54c-1fbfb34b0477 63843-547 HUMAN OTC DRUG REGIMEN ANTIMICROBIAL CHLOROXYLENOL SOAP TOPICAL 20130924 OTC MONOGRAPH NOT FINAL part333E HealthLink CHLOROXYLENOL 5 g/1000mL 63843-727_65f6c1af-3b18-4163-9c0d-981ee4854ea8 63843-727 HUMAN OTC DRUG GBG AloeGel ALCOHOL GEL TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part333 HealthLink ALCOHOL .7 mL/mL 63843-729_744d492e-5d36-49cc-9037-adbf89c081f2 63843-729 HUMAN OTC DRUG AloeGuard CHLOROXYLENOL SOAP TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part333 HealthLink CHLOROXYLENOL .005 mL/mL 63843-773_ce01b653-1be1-45d6-9661-d76f9b238e97 63843-773 HUMAN OTC DRUG GBGF ALCOHOL AEROSOL, FOAM TOPICAL 20090701 OTC MONOGRAPH NOT FINAL part333E Healthlink ALCOHOL 620 mg/g 63843-898_219e38dc-9b49-400e-a0bf-5891dcde5700 63843-898 HUMAN OTC DRUG GBG Alcohol AEROSOL, FOAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333E HealthLink ALCOHOL .62 g/g 63850-0021_b7e4200c-feff-4537-aad1-cf9989fd8c14 63850-0021 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20101007 ANDA ANDA091630 Natco Pharma Limited-Pharma Division TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 63850-0022_b7e4200c-feff-4537-aad1-cf9989fd8c14 63850-0022 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20101007 ANDA ANDA091630 Natco Pharma Limited-Pharma Division TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 63851-501_a9902fa8-00c8-44ac-bf71-1e0cdd8eca90 63851-501 VACCINE RabAvert Rabies Vaccine KIT INTRAMUSCULAR 20140708 BLA BLA103334 Novartis Vaccines and Diagnostics GmbH 63851-612_e2f91bc2-f0dc-462c-87bf-847d95aad516 63851-612 VACCINE Flucelvax INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20130830 BLA BLA125408 Novartis Vaccines and Diagnostics GmbH INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL 63868-002_00a77364-aad1-4d9b-b006-9260e7c22eb3 63868-002 HUMAN OTC DRUG NATURA-LAX polyethylene glycol 3350 POWDER, FOR SOLUTION ORAL 20140501 ANDA ANDA090812 Chain Drug Marketing Association POLYETHYLENE GLYCOL 3350 17 g/17g 63868-003_06ac99ec-0f6e-61ed-e054-00144ff8d46c 63868-003 HUMAN OTC DRUG Severe Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20120724 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 63868-004_06ac99ec-0f44-61ed-e054-00144ff8d46c 63868-004 HUMAN OTC DRUG Cold and Cough ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20120724 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 63868-005_06a92a2e-9c3f-2a7c-e054-00144ff88e88 63868-005 HUMAN OTC DRUG Severe Cold Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20120724 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 63868-006_06ba032d-b5ed-115f-e054-00144ff88e88 63868-006 HUMAN OTC DRUG Sinus Congestion and Pain Daytime Nighttime Acetaminophen, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride KIT 20120724 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association 63868-008_7239eecd-967c-4be3-901c-f80ce98c9af2 63868-008 HUMAN OTC DRUG Lansoprazole Heartburn Relief 24 Hour Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130430 ANDA ANDA202727 QUALITY CHOICE (Chain Drug Marketing Association) LANSOPRAZOLE 15 mg/1 63868-011_dd540cf3-781c-4260-aded-9540b7acb21d 63868-011 HUMAN OTC DRUG DayTime NightTime Cold/Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130115 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) 63868-012_fd590103-7b29-4783-af34-cd3893643384 63868-012 HUMAN OTC DRUG QC Cold and Hot Pain Relief Menthol PATCH TOPICAL 20110912 OTC MONOGRAPH NOT FINAL part348 CHAIN DRUG MARKETING ASSOCIATION INC MENTHOL 400 mg/1 63868-013_b10e06e9-259c-4e88-9837-b0879799d424 63868-013 HUMAN OTC DRUG Quality Choice Muscle and Joint Menthol GEL TOPICAL 20110916 OTC MONOGRAPH NOT FINAL part348 Chain Drug Marketing Association MENTHOL 2.5 g/100g 63868-014_ac8f2a89-b672-489c-8675-07fefd575d7a 63868-014 HUMAN OTC DRUG EZ Nite Sleep Nighttime Sleep-Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130311 OTC MONOGRAPH FINAL part338 QUALITY CHOICE (Chain Drug Marketing Association) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63868-015_06ba032d-b607-115f-e054-00144ff88e88 63868-015 HUMAN OTC DRUG Cold Multi Symptom Daytime Nighttime Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride KIT 20130306 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association 63868-024_6fc3876e-6d31-4665-aa80-787941caf6bf 63868-024 HUMAN OTC DRUG Fexofenadine HCl Fexofenadine HCl TABLET ORAL 20120827 ANDA ANDA079112 Chain Drug Marketing Association FEXOFENADINE HYDROCHLORIDE 180 mg/1 63868-026_f145057a-ab68-475b-87df-a703ee3993b8 63868-026 HUMAN OTC DRUG Quality Choice Earwax Removal Kit CARBAMIDE PEROXIDE LIQUID TOPICAL 20141127 OTC MONOGRAPH FINAL part344 Chain Drug Marketing Association, Inc. CARBAMIDE PEROXIDE 65 mg/mL 63868-047_c1171d19-5694-4e6c-9865-40c5f62c4f05 63868-047 HUMAN OTC DRUG Quality Choice Chewable Antacid Assorted Fruit Antacid Tablets TABLET, CHEWABLE ORAL 20140207 OTC MONOGRAPH FINAL part331 Chain Drug Marketing Association CALCIUM CARBONATE 500 mg/1 63868-060_78e37de0-2735-4845-a5fb-5609436a887e 63868-060 HUMAN OTC DRUG Instant Antiseptic Pain Relief Camphor 10.8% and Phenol 4.7% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part348 Chain Drug Market Association CAMPHOR (NATURAL); PHENOL 108; 47 mg/mL; mg/mL 63868-063_f8706810-fc9c-4b36-a726-335bc9947a34 63868-063 HUMAN OTC DRUG Childrens Plus Multi-Symptom Cold Grape with PE ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE SUSPENSION ORAL 20091023 OTC MONOGRAPH FINAL part341 Quality Choice ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 63868-065_88f22bec-566a-4745-98f7-920b0d836963 63868-065 HUMAN OTC DRUG Cold and Cough Nighttime Cool Blast Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 1000; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 63868-067_004cdda6-049e-47a5-bc86-09af94027691 63868-067 HUMAN OTC DRUG Daytime Flu Relief Therapy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 63868-068_f564b909-fcdf-4f2f-958d-4f68c0f4907a 63868-068 HUMAN OTC DRUG Nighttime Cold and Flu Relief Therapy Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL 63868-069_734de920-0c29-4f95-9b22-0ab949fdb6fe 63868-069 HUMAN OTC DRUG Cough Relief Dextromethorphan HBr LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 63868-070_568c861f-02f8-427e-9cb0-b69e760bc0e6 63868-070 HUMAN OTC DRUG Childrens Cough Relief Dextromethorphan HBr LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 63868-071_06a92a2e-9c03-2a7c-e054-00144ff88e88 63868-071 HUMAN OTC DRUG Severe Sinus Congestion and Pain ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20091113 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 63868-072_06ac9e02-95af-3046-e054-00144ff88e88 63868-072 HUMAN OTC DRUG Cold Multi Symptom Nighttime ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20091113 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 63868-073_06ac9e02-959a-3046-e054-00144ff88e88 63868-073 HUMAN OTC DRUG Severe Cold Multi Symptom ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20091113 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 63868-074_06ac99ec-0f59-61ed-e054-00144ff8d46c 63868-074 HUMAN OTC DRUG Cold Head Congestion Nighttime ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20091113 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 63868-075_06ba032d-b5d8-115f-e054-00144ff88e88 63868-075 HUMAN OTC DRUG Severe Cold Head Congestion Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20091113 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 63868-076_a6433e39-5680-4efd-8955-969c3cc1dee9 63868-076 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen SUSPENSION ORAL 20091101 ANDA ANDA079058 Chain Drug Marketing Association Inc. IBUPROFEN 50 mg/1.25mL 63868-082_066f3051-0683-62ea-e054-00144ff8d46c 63868-082 HUMAN OTC DRUG Pain Relief Regular Strength Acetaminophen TABLET ORAL 20140613 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ACETAMINOPHEN 325 mg/1 63868-083_066f3051-0696-62ea-e054-00144ff8d46c 63868-083 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20140613 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ACETAMINOPHEN 500 mg/1 63868-084_06ba7619-b3ea-70a4-e054-00144ff88e88 63868-084 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20140613 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ACETAMINOPHEN 500 mg/1 63868-087_06a92a2e-9bf0-2a7c-e054-00144ff88e88 63868-087 HUMAN OTC DRUG Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20081110 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63868-088_06ba7a68-6198-25ea-e054-00144ff88e88 63868-088 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20120827 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ACETAMINOPHEN 500 mg/1 63868-089_d7fb4028-7bc9-4008-b590-7c44ad73d2bc 63868-089 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Chain Drug Marketing Association Inc. ACETAMINOPHEN 650 mg/1 63868-090_c47d067c-13d3-473e-b7a0-3227241b9ec6 63868-090 HUMAN OTC DRUG Non Aspirin PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130105 OTC MONOGRAPH FINAL part338 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 63868-091_66ada349-e26c-493f-95dd-4ae3a2ba3c30 63868-091 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Chain Drug Marketing Association Inc. ACETAMINOPHEN 650 mg/1 63868-092_5241de2d-a972-4da8-a677-fdd31d7769c2 63868-092 HUMAN OTC DRUG Quality Choice Childrens Allergy Relief Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Chain Drug Marketing Association, Inc. LORATADINE 5 mg/5mL 63868-093_f4c39cea-9a5e-45f4-bcf8-c372ef81ce86 63868-093 HUMAN OTC DRUG Quality Choice Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Chain Drug Marketing Association Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL 63868-094_5fd125c7-3cfa-4970-8b9a-89f342f480f1 63868-094 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130320 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 63868-097_da2a5658-5464-49c5-bbaa-60b512b63648 63868-097 HUMAN OTC DRUG Quality Choice Anti-Itch Clear Zinc Acetate and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Chain Drug Market Association PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 10; 80 mg/mL; mg/mL 63868-099_a049abe2-7cbd-4507-a390-06f5972c3d93 63868-099 HUMAN OTC DRUG Quality Choice Hydrocortisone Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Chain Drug Marketing Association HYDROCORTISONE 1 g/100g 63868-100_28b8ddbe-d4d0-4853-b053-6938705f1748 63868-100 HUMAN OTC DRUG QUALITY CHOICE Antibacterial Moist Towelettes BENZALKONIUM CHLORIDE CLOTH TOPICAL 20130103 OTC MONOGRAPH NOT FINAL part333A Chain Drug Marketing Association BENZALKONIUM CHLORIDE .1 g/1 63868-101_175c2f55-552a-4073-bbc2-3b8d2ca333b4 63868-101 HUMAN OTC DRUG Quality Choice Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20100104 UNAPPROVED DRUG OTHER Chain Drug Marketing Association PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 63868-104_80b1ae5c-9767-4570-9600-ca1472187518 63868-104 HUMAN OTC DRUG Quality Choice Tolnaftate Antifungal TOLNAFTATE CREAM TOPICAL 20130531 OTC MONOGRAPH FINAL part333C Chain Drug Marketing Association Inc TOLNAFTATE 1 g/100g 63868-106_c07a584b-051e-4350-a1ee-052d0e281ebc 63868-106 HUMAN OTC DRUG Quality Choice Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Chain Drug Marketing Association CETIRIZINE HYDROCHLORIDE 5 mg/5mL 63868-107_e561e532-fbcf-4f69-9e11-a0a70420d8a8 63868-107 HUMAN OTC DRUG All Day Allergy Relief Cetirizine HCl CAPSULE ORAL 20130303 NDA NDA022429 QUALITY CHOICE (Chain Drug Marketing Association) CETIRIZINE HYDROCHLORIDE 10 mg/1 63868-109_06a826d2-da00-2dd8-e054-00144ff8d46c 63868-109 HUMAN OTC DRUG Stay Awake CAFFEINE TABLET ORAL 20140613 OTC MONOGRAPH FINAL part340 Chain Drug Marketing Association CAFFEINE 200 mg/1 63868-116_22a5d490-8468-4667-8568-4d095abbb7fc 63868-116 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) DOCUSATE SODIUM 100 mg/1 63868-123_d97544db-beda-4dc0-9eec-83636ef2f14a 63868-123 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141031 NDA NDA021920 QUALITY CHOICE (Chain Drug Marketing Association) NAPROXEN SODIUM 220 mg/1 63868-125_458a43cc-97ea-4fa5-a251-500dc781b421 63868-125 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100714 OTC MONOGRAPH FINAL part332 QUALITY CHOICE (Chain Drug Marketing Association) DIMETHICONE 125 mg/1 63868-126_7a8d5b35-06f5-49f8-9e14-79ad8fc92da9 63868-126 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20140131 OTC MONOGRAPH FINAL part347 QUALITY CHOICE (Chain Drug Marketing Association) DIMETHICONE 125 mg/1 63868-131_4672e211-0002-4741-be52-c287670ca9af 63868-131 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20101104 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 63868-132_47013191-5acd-464a-91b2-c2aee8b3d234 63868-132 HUMAN OTC DRUG Quality Choice Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Chain Drug Marketing Association Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 63868-133_7987339d-a8ac-439e-bd02-504e46ccbb72 63868-133 HUMAN OTC DRUG Quality Choice Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Chain Drug Marketing Association CETIRIZINE HYDROCHLORIDE 5 mg/5mL 63868-143_164c7698-4349-410d-8be1-a8e2a4837110 63868-143 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Chain Drug Marketing Association Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 63868-144_9931e3b2-b434-4d34-8360-6ae236de4440 63868-144 HUMAN OTC DRUG Nasal Decongestant PE Non-Drowsy Maximum Strength Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 CHAIN DRUG MARKETING ASSOCIATION INC PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 63868-145_6d6d633c-5a02-4813-9b41-9a36376a32a6 63868-145 HUMAN OTC DRUG Cough and Cold Relief HBP Chlorpheniramine maleate and Dextromethorphan HBr TABLET ORAL 20030503 OTC MONOGRAPH FINAL part341 CHAIN DRUG MARKETING ASSOCIATION INC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 63868-146_42d3368c-7ce0-4ff4-b923-68133637efb3 63868-146 HUMAN OTC DRUG Maximum Strength Suphedrine Pseudoephedrine HCl TABLET ORAL 19810825 OTC MONOGRAPH FINAL part341 CHAIN DRUG MARKETING ASSOCIATION INC PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 63868-151_4d81a3ac-7d56-4d16-b0d6-32c1122004e3 63868-151 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Chain Drug Marketing Association Inc. LORATADINE 10 mg/1 63868-154_16bb532d-2a51-49d5-bea5-72bf47286ddb 63868-154 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Chain Drug Marketing Association Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 63868-156_363c7fea-4d11-4c40-895e-1bcb1d2ffdad 63868-156 HUMAN OTC DRUG Quality Choice Childrens Allergy Relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Chain Drug Marketing Association LORATADINE 5 mg/5mL 63868-157_f1415ccc-2075-46be-9778-002df4ea835d 63868-157 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Chain Drug Marketing Association Inc. LORATADINE 10 mg/1 63868-158_7fc76f83-2efe-412a-9fa0-531a6308def9 63868-158 HUMAN OTC DRUG Junior Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ACETAMINOPHEN 160 mg/1 63868-159_bbbd2162-c132-42db-ac4d-2245392a3d9f 63868-159 HUMAN OTC DRUG Headache Relief PM Acetaminophen and Diphenhydramine Citrate TABLET ORAL 20040607 OTC MONOGRAPH FINAL part338 CHAIN DRUG MARKETING ASSOCIATION INC ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 63868-160_08ef705a-2b53-4761-b851-0bce95d16505 63868-160 HUMAN OTC DRUG Travel Sickness Dimenhydrinate TABLET ORAL 20100714 OTC MONOGRAPH FINAL part336 QUALITY CHOICE (Chain Drug Marketing Association) DIMENHYDRINATE 50 mg/1 63868-163_a1db7451-c5bb-4c29-912f-03838e26a268 63868-163 HUMAN OTC DRUG Travel Ease Meclizine HCl TABLET, CHEWABLE ORAL 20020529 OTC MONOGRAPH FINAL part336 CHAIN DRUG MARKETING ASSOCIATION INC MECLIZINE HYDROCHLORIDE 25 mg/1 63868-164_edf9e143-c2cc-4877-a7b3-cda18aa6a7b9 63868-164 HUMAN OTC DRUG Quality Choice Quick Relief Diaper Rash Zinc Oxide CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part347 Chain Drug Marketing Association ZINC OXIDE 13 g/100g 63868-165_5bec85c7-d69c-4ca7-a345-950cc030f41e 63868-165 HUMAN OTC DRUG Quality Choice Maximum Strength Diaper Rash Zinc Oxide CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part347 Chain Drug Marketing Association ZINC OXIDE 40 g/100g 63868-170_a958dac3-8156-4222-a379-82fb3c229a74 63868-170 HUMAN OTC DRUG QUALITY CHOICE OMEPRAZOLE omeprazole TABLET, DELAYED RELEASE ORAL 20140301 NDA NDA022032 Chain Drug Marketing Association OMEPRAZOLE 20 mg/1 63868-172_043ca44e-190a-4e36-bed1-02a6c0b0ae13 63868-172 HUMAN OTC DRUG Quality Choice Natural White Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 CHAIN DRUG MARKETING ASSOCIATION INC POTASSIUM NITRATE; SODIUM FLUORIDE 5; .24 g/100g; g/100g 63868-174_654cbe50-7ec0-4861-8f57-5b3c3224526c 63868-174 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen SUSPENSION ORAL 20141031 OTC MONOGRAPH NOT FINAL part343 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN 160 mg/5mL 63868-177_d1583464-8f8c-a186-6099-74a7c3840114 63868-177 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20121211 ANDA ANDA078878 Chain Drug Marketing Association OMEPRAZOLE MAGNESIUM 20 mg/1 63868-189_a15c8065-7c17-4354-a59f-c41da3db75b3 63868-189 HUMAN OTC DRUG Nicotine Polacrilex, Coated Fruit Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 19991001 ANDA ANDA079044 Chain Drug Marketing Association Inc. NICOTINE 2 mg/1 63868-190_e38c24f2-0867-44f4-bb5e-b896af84ba7d 63868-190 HUMAN OTC DRUG Nicotine Transdermal System Step 1 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 19991001 ANDA ANDA074612 Chain Drug Marketing Association Inc. NICOTINE 21 mg/24h 63868-191_e38c24f2-0867-44f4-bb5e-b896af84ba7d 63868-191 HUMAN OTC DRUG Nicotine Transdermal System Step 2 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 19991001 ANDA ANDA074612 Chain Drug Marketing Association Inc. NICOTINE 14 mg/24h 63868-192_3faed1cd-8aee-4a0f-a392-686cbb3fd7dc 63868-192 HUMAN OTC DRUG Nicotine Polacrilex, Coated Mint Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 19991001 ANDA ANDA076569 Chain Drug Marketing Association Inc. NICOTINE 2 mg/1 63868-193_3faed1cd-8aee-4a0f-a392-686cbb3fd7dc 63868-193 HUMAN OTC DRUG Nicotine Polacrilex, Coated Mint Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 19991001 ANDA ANDA076568 Chain Drug Marketing Association Inc. NICOTINE 4 mg/1 63868-194_a15c8065-7c17-4354-a59f-c41da3db75b3 63868-194 HUMAN OTC DRUG Nicotine Polacrilex, Coated Fruit Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 19991001 ANDA ANDA079038 Chain Drug Marketing Association Inc. NICOTINE 4 mg/1 63868-195_57713d18-39d8-44a4-b50c-7ac66b26e5f1 63868-195 HUMAN OTC DRUG Nicotine Polacrilex, Original Nicotine Polacrilex GUM, CHEWING BUCCAL 19991001 ANDA ANDA074707 Chain Drug Marketing Association Inc. NICOTINE 4 mg/1 63868-196_57713d18-39d8-44a4-b50c-7ac66b26e5f1 63868-196 HUMAN OTC DRUG Nicotine Polacrilex, Original Nicotine Polacrilex GUM, CHEWING BUCCAL 19991001 ANDA ANDA074507 Chain Drug Marketing Association Inc. NICOTINE 2 mg/1 63868-197_8d8b54e5-1580-48a3-bb39-8e3e61a4e68f 63868-197 HUMAN OTC DRUG Quality Choice 3 Day Vaginal Miconazole Nitrate CREAM VAGINAL 20050302 ANDA ANDA076773 Chain Drug Marketing Association MICONAZOLE NITRATE 40 mg/g 63868-198_c5966367-2fc1-46e9-83ae-9508fc42fb95 63868-198 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20100701 ANDA ANDA074164 CDMA/Quality Choice MICONAZOLE NITRATE 2 g/100g 63868-200_d40cb705-70be-40b2-a5e9-d6c4e8780978 63868-200 HUMAN OTC DRUG Hydrocortisone Maximum Strength with Aloe Hydrocortisone CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part348 Chain Drug Marketing Association Inc. HYDROCORTISONE 1 g/100g 63868-201_5f7c9070-727e-4bb2-8044-18c098e400a8 63868-201 HUMAN OTC DRUG Quality Choice Hemorrhoidal Mineral Oil OINTMENT RECTAL; TOPICAL 20130630 OTC MONOGRAPH FINAL part346 Chain Drug Marketing Association MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 749; 2.5 mg/100g; mg/100g; mg/100g 63868-202_d40cb705-70be-40b2-a5e9-d6c4e8780978 63868-202 HUMAN OTC DRUG Hydrocortisone Maximum Strength with Aloe Hydrocortisone CREAM TOPICAL 20111107 OTC MONOGRAPH NOT FINAL part348 Chain Drug Marketing Association Inc. HYDROCORTISONE 1 g/100g 63868-205_18d8f61a-a03d-4a6a-9ca0-4447b8c39c94 63868-205 HUMAN OTC DRUG Therapeutic Plus Coal Tar SHAMPOO TOPICAL 20040526 OTC MONOGRAPH FINAL part358H C.D.M.A., INC COAL TAR 25 mg/mL 63868-208_3f40247b-9c06-456c-87d0-d253163cd62a 63868-208 HUMAN OTC DRUG Hemorrhoidal COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY RECTAL 20070926 OTC MONOGRAPH FINAL part346 Chain Drug Marketing Association, Inc. COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 1768.8; 5 mg/1; mg/1 63868-209_d26acc88-5087-46ad-962f-41ed0dcec888 63868-209 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET ORAL 20140831 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) BISACODYL 5 mg/1 63868-218_7a6a70b7-0fd4-4d4d-882f-93053c77cf41 63868-218 HUMAN OTC DRUG Anti itch Topical Analgesic Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part348 Chain Drug Marketing Associations Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 63868-228_d780154d-fa98-453b-b9ba-aceb7435b832 63868-228 HUMAN OTC DRUG Quality Choice Effervescent Cold Relief Plus Aspirin, Chlorpheniramine maleate, and Phenylephrine bitartrate TABLET, EFFERVESCENT ORAL 20140101 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 63868-230_6079fc00-3cad-42a4-9a28-614800e1879f 63868-230 HUMAN OTC DRUG Quality Choice Povidone Iodine Povidone Iodine 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Chain Drug Market Association POVIDONE-IODINE 100 mg/mL 63868-240_06a92a2e-9b88-2a7c-e054-00144ff88e88 63868-240 HUMAN OTC DRUG Chewable Aspirin ASPIRIN TABLET, CHEWABLE ORAL 20140613 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ASPIRIN 81 mg/1 63868-244_343d70c0-1b24-4b8e-aef4-e440494cafbe 63868-244 HUMAN OTC DRUG Tussin CF Non Drowsy Dextromethorphan HBr, Guaifenesin, Phenylephrine LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 63868-246_77008ba4-20aa-4b5b-ae3c-ece24562db3f 63868-246 HUMAN OTC DRUG Childrens Dibromm Cold and Allergy Brompheniramine maleate, Phenylephrine HCl LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL 63868-247_ea7f1307-2bcc-4691-9dfc-94e6b6bedfa9 63868-247 HUMAN OTC DRUG Childrens Dibromm Cold and Cough Brompheniramine maleate, Phenylephrine HCl LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 63868-248_ed1f13f0-973e-402e-8638-9602d33f969e 63868-248 HUMAN OTC DRUG EZ Nite Sleep Nighttime Sleep-Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140731 OTC MONOGRAPH FINAL part338 QUALITY CHOICE (Chain Drug Marketing Association) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63868-249_91dcaea1-bb34-484b-9798-94dd4e0aa49b 63868-249 HUMAN OTC DRUG Awaken Oil-Free Daily Face Wash Salicylic Acid CREAM TOPICAL 20140901 OTC MONOGRAPH FINAL part333D Chain Drug Marketing Association SALICYLIC ACID 2 g/100mL 63868-250_d09af2b3-62da-447d-bb7d-a68db1fa155a 63868-250 HUMAN OTC DRUG Awaken by Quality Choice Ultra Clean Daily Face Wash Salicylic Acid CREAM TOPICAL 20140901 OTC MONOGRAPH FINAL part333D Chain Drug Marketing Association SALICYLIC ACID 2 g/100g 63868-251_e89a3265-1876-4dee-b69f-66dc13e4feeb 63868-251 HUMAN OTC DRUG Awaken by Quality Choice Anti-Wrinkle and Firming Moisturizer Day Broad Spectrum SPF18 Sunscreen Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Chain Drug Marketing Association AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 5 g/100g; g/100g; g/100g 63868-252_1a776be8-78cc-4fd7-a969-99a0dae954a2 63868-252 HUMAN OTC DRUG Awaken Skin Perfector BB Broad Spectrum SPF 15 Sunscreen Light Medium Octinoxate and Titanium Dioxide CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Chain Drug Marketing Association OCTINOXATE; TITANIUM DIOXIDE 4; 2.1 g/100mL; g/100mL 63868-253_991dba6e-f85c-445d-b0e5-c433cd15253a 63868-253 HUMAN OTC DRUG Awaken Skin Perfector BB Broad Spectrum SPF 15 Sunscreen Medium Dark Octinoxate and Titanium Dioxide CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Chain Drug Marketing Association OCTINOXATE; TITANIUM DIOXIDE 4; 2.1 g/100mL; g/100mL 63868-254_9c7d780f-7c48-4795-867c-5104d4bdf0ed 63868-254 HUMAN OTC DRUG Awaken by Quality Choice Illuminating Daily Moisturizer Broad Spectrum SPF 15 Sunscreen Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Chain Drug Marketing Association AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 g/100g; g/100g; g/100g 63868-255_c3fd61cc-5645-4831-9917-55c24b161d70 63868-255 HUMAN OTC DRUG Awaken by Quality Choice Long-Lasting Oil-Free Moisturizer Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene and Oxybenzone CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Chain Drug Marketing Association AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 4; 3 g/100g; g/100g; g/100g; g/100g 63868-256_455679dc-6624-40c3-9186-83e194e70c32 63868-256 HUMAN OTC DRUG Awaken by Quality Choice Absolute Daily Moisturizer Broad Spectrum SPF 15 Sunscreen Octinoxate and Zinc Oxide CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Chain Drug Marketing Association OCTINOXATE; ZINC OXIDE 6; 3 g/100g; g/100g 63868-257_aea280de-7250-47df-9271-8bbf713cddaf 63868-257 HUMAN OTC DRUG Natural Vegetable Laxative Sennosides TABLET ORAL 19950127 OTC MONOGRAPH NOT FINAL part334 CHAIN DRUG MARKETING ASSOCIATION INC SENNOSIDES 8.6 mg/1 63868-259_44322667-abbc-47f9-8156-69a8ff199b95 63868-259 HUMAN OTC DRUG Clotrimazole clotrimazole CREAM VAGINAL 20141015 ANDA ANDA074165 Chain Drug Marketing Association Inc. CLOTRIMAZOLE 1 g/100g 63868-262_cd64a1c0-b097-4b7d-9b7a-e54b629254d9 63868-262 HUMAN OTC DRUG Stool Softener Plus Laxative Docusate sodium, Sennosides TABLET ORAL 20140831 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 63868-266_0c545df3-607f-4711-bd85-cfa1da21f1b4 63868-266 HUMAN OTC DRUG Chocolated Laxative Sennosides Stimulant Laxative TABLET, CHEWABLE ORAL 20140101 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association, Inc.) SENNOSIDES 15 mg/1 63868-267_be153570-f2c4-48d1-b987-33ad3ef630c7 63868-267 HUMAN OTC DRUG Vapor Inhaler Levmetamfetamine Nasal Decongestant INHALANT NASAL 20140101 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association, Inc. LEVMETAMFETAMINE 50 mg/1 63868-279_c45927df-8ccb-4e04-8d86-2504352c92ab 63868-279 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part333A C.D.M.A. BENZALKONIUM CHLORIDE 1.3 g/mL 63868-310_45419ab8-43f3-4ffb-8583-fece4271cd82 63868-310 HUMAN OTC DRUG MILK OF MAGNESIA CHERRY magnesium hydroxide LIQUID ORAL 20140401 OTC MONOGRAPH NOT FINAL part334 Chain Drug Marketing Association MAGNESIUM HYDROXIDE 1200 mg/15mL 63868-317_cafc675d-602b-4ff9-b736-d7b5ccc503ac 63868-317 HUMAN OTC DRUG Quality Choice Calamine Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Chain Drug Market Association ZINC OXIDE 160 mg/mL 63868-322_f9ac6ca1-7979-40a1-82c4-089f020131ec 63868-322 HUMAN OTC DRUG Quality Choice Castor Oil Castor Oil LIQUID ORAL 20080101 OTC MONOGRAPH NOT FINAL part334 Chain Drug Market Asociation CASTOR OIL 1 mg/mL 63868-325_066f3051-06cf-62ea-e054-00144ff8d46c 63868-325 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, COATED ORAL 20071108 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 63868-326_0f111525-185c-4dd6-91d5-5ac880e09e3b 63868-326 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130826 OTC MONOGRAPH NOT FINAL part356 C.D.M.A., Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 63868-328_545418af-ffb3-4c46-9548-c4ecf71b1b7d 63868-328 HUMAN OTC DRUG Laxative BISACODYL SUPPOSITORY RECTAL 20071221 OTC MONOGRAPH NOT FINAL part334 Chain Drug Marketing Association, Inc. BISACODYL 10 mg/1 63868-330_c6b24805-cd97-448f-aa67-eac0abf70cc6 63868-330 HUMAN OTC DRUG Quality Choice Iodine Tincture Mild Iodine and Sodium Iodide and Alcohol LIQUID TOPICAL 19790101 OTC MONOGRAPH NOT FINAL part333A Chain Drug Market Association ALCOHOL; IODINE; SODIUM IODIDE 470; 20; 20.4 mg/mL; mg/mL; mg/mL 63868-331_be6536e7-bb0c-45db-899c-7215bafe11a3 63868-331 HUMAN OTC DRUG Quality Choice Iodides Tincture Ethyl Alcohol LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A Chain Drug Market Association ALCOHOL .45 mL/mL 63868-338_c91f9b96-ee50-410f-87de-ee30135422ac 63868-338 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Chain Drug Marketing Association Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 63868-352_63ba34d1-df5c-4f2b-928d-e7b94aaee9f5 63868-352 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ASPIRIN 325 mg/1 63868-354_650e3390-0320-472d-82e1-8c2164281e2a 63868-354 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 QUALITY CHOICE (Chain Drug Marketing Association) ASPIRIN 81 mg/1 63868-359_a2138bbc-9129-4320-8433-5b549f4831fd 63868-359 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate OINTMENT TOPICAL 20070829 OTC MONOGRAPH FINAL part333B Chain Drug Marketing Association Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 63868-363_c3454b74-26d2-4068-98fc-79a5514c0273 63868-363 HUMAN OTC DRUG Enteric Coated Asprin 81 mg Aspirin TABLET ORAL 20110502 OTC MONOGRAPH FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ASPIRIN 81 mg/1 63868-364_f7c65393-e192-47eb-8272-9ab447c41ee1 63868-364 HUMAN OTC DRUG Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Chain Drug Marketing Association, Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g 63868-368_5ba2e064-9db8-43e2-92dd-5c8b56563d8a 63868-368 HUMAN OTC DRUG Childrens Triacting Nighttime Cold and Cough Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20140530 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 63868-369_da86f071-d076-4f4a-a002-956c639f5632 63868-369 HUMAN OTC DRUG Triacting Daytime Cold Cough Childrens Dextromethorphan HBr, Phenylephrine HCl SYRUP ORAL 20140530 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 63868-370_3793a51e-ba91-4830-8b75-b3e68c3ab435 63868-370 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20140530 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 63868-373_06ba7619-b3d3-70a4-e054-00144ff88e88 63868-373 HUMAN OTC DRUG Aspirin 81 mg ASPIRIN TABLET, DELAYED RELEASE ORAL 20140613 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ASPIRIN 81 mg/1 63868-384_54d2911a-4f2b-4047-b9be-700db19f2ad6 63868-384 HUMAN OTC DRUG Quality Choice Nighttime Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20121129 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 63868-386_1162a5ed-136d-4a32-b090-c647d0e079a8 63868-386 HUMAN OTC DRUG Quality Choice Multi-Symptom, Non-Drowsy DayTime Cold and Flu ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED ORAL 20121108 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 63868-406_f6636fa7-c50c-4c2b-bc4c-da7f21836a1c 63868-406 HUMAN OTC DRUG Quality Choice Cold Sore Treatment Benzalkonium Chloride CREAM TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part333A Chain Drug Marketing Association Inc BENZALKONIUM CHLORIDE 1.3 mg/g 63868-453_9b971e5f-98b5-4030-96d0-2b8aa5c03609 63868-453 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Chain Drug Marketing Association Inc. IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 63868-465_06ba032d-b5af-115f-e054-00144ff88e88 63868-465 HUMAN OTC DRUG Naproxen Sodium NAPROXEN SODIUM TABLET, COATED ORAL 20090903 ANDA ANDA079096 Chain Drug Marketing Association NAPROXEN SODIUM 220 mg/1 63868-466_06ba032d-b5c4-115f-e054-00144ff88e88 63868-466 HUMAN OTC DRUG Naproxen Sodium NAPROXEN SODIUM TABLET, COATED ORAL 20090619 ANDA ANDA079096 Chain Drug Marketing Association NAPROXEN SODIUM 220 mg/1 63868-485_2bf7e2ad-de5d-4a61-8ddf-444421ad9e87 63868-485 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 63868-486_20a81e6f-a829-46d0-a486-136302b0ef61 63868-486 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100723 ANDA ANDA090283 Chain Drug Marketing Association Inc. FAMOTIDINE 20 mg/1 63868-487_101b4abe-d563-46bd-b6af-2c16116d3ed3 63868-487 HUMAN OTC DRUG ACID REDUCER Ranitidine TABLET ORAL 20120330 ANDA ANDA200536 Chain Drug Marketing Association Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 63868-489_2f85ad6b-7717-41e7-bd6b-0c3e60fe4816 63868-489 HUMAN OTC DRUG Quality Choice Aromatic Ammonia Spirit Ammonia 2% LIQUID TOPICAL 20080101 UNAPPROVED DRUG OTHER Chain Drug Market Association AMMONIA 20 mg/mL 63868-490_778373fc-bd4a-4f37-b90f-dac13c3f001c 63868-490 HUMAN OTC DRUG Quality Choice Camphor Spirit Camphor 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part348 Chain Drug Market Association CAMPHOR (NATURAL) 100 mg/mL 63868-492_06a925de-0832-2754-e054-00144ff88e88 63868-492 HUMAN OTC DRUG Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20140613 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63868-493_6e581fb4-5a66-423e-9742-80f7ea705e3d 63868-493 HUMAN OTC DRUG Quality Choice Merthiolate Benzalkonium Chloride LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A Chain Drug Market Association BENZALKONIUM CHLORIDE 1.3 mg/mL 63868-503_066f3051-06e3-62ea-e054-00144ff8d46c 63868-503 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20070315 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ACETAMINOPHEN 500 mg/1 63868-507_066f3051-06bc-62ea-e054-00144ff8d46c 63868-507 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20070814 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ACETAMINOPHEN 500 mg/1 63868-518_f64f0600-115f-49f4-abe2-d80550ae2ddb 63868-518 HUMAN OTC DRUG Quality Choice Hemorrhoid witch hazel CLOTH TOPICAL 20140416 OTC MONOGRAPH FINAL part346 Chain Drug Marketing Association (CDMA) WITCH HAZEL 500 mg/L 63868-549_bab76124-6cc9-4bd1-99d8-4c8fc5c6c6f8 63868-549 HUMAN OTC DRUG Laxative Maximum Strength Sennosides TABLET ORAL 20100331 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) SENNOSIDES 25 mg/1 63868-611_066f1786-03e9-02cc-e054-00144ff8d46c 63868-611 HUMAN OTC DRUG Nighttime Sleep Aid DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20070625 OTC MONOGRAPH FINAL part338 Chain Drug Marketing Association DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63868-612_be3caab8-a4e8-4e44-b391-328ff7b066b3 63868-612 HUMAN OTC DRUG Sleep aid Maximum Strength DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 63868-632_6cc12487-23a4-4366-8880-6f648f8042f2 63868-632 HUMAN OTC DRUG Icy Cool Maximum Strength Menthol GEL TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 C.D.M.A. Inc. MENTHOL 55 mg/mL 63868-633_0e6e835a-a87d-4a1b-b3c8-b3319b4f9473 63868-633 HUMAN OTC DRUG Icy Cool Maximum Strength Menthol GEL TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 C.D.M.A. Inc. MENTHOL 55 mg/mL 63868-664_44f0f6eb-333b-441e-9ce6-44aac4c1ef69 63868-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19950111 OTC MONOGRAPH NOT FINAL part356 C.D.M.A., Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 63868-687_5bcf91a9-9644-488a-a191-0071e0fbe0b3 63868-687 HUMAN OTC DRUG Therapeutic T Plus Coal Tar SHAMPOO TOPICAL 20130530 OTC MONOGRAPH FINAL part358H Chain Drug Marketing Association COAL TAR 25 mg/mL 63868-694_b47b2424-925a-4016-80ee-8d510d6c29c5 63868-694 HUMAN OTC DRUG ANTACID MINT aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20140301 OTC MONOGRAPH FINAL part331 Chain Drug Marketing Association ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 63868-711_1300e024-05f2-4280-aa5f-fbbd17b3b0b8 63868-711 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20120710 ANDA ANDA201745 Chain Drug Marketing Association Inc. RANITIDINE HYDROCHLORIDE 75 mg/1 63868-712_3f5dcd28-e57f-40d6-b4a8-98399a6dd339 63868-712 HUMAN OTC DRUG REGULAR STRENGTH ANTACID aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20140301 OTC MONOGRAPH FINAL part331 Chain Drug Marketing Association ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 63868-714_20a81e6f-a829-46d0-a486-136302b0ef61 63868-714 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100625 ANDA ANDA090283 Chain Drug Marketing Association Inc. FAMOTIDINE 10 mg/1 63868-716_06ba7913-286e-1723-e054-00144ff8d46c 63868-716 HUMAN OTC DRUG Mucus Relief Severe Cold ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130924 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 63868-717_06ba7913-2858-1723-e054-00144ff8d46c 63868-717 HUMAN OTC DRUG Mucus Relief Cold and Sinus ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130924 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 63868-719_06ba7a68-6181-25ea-e054-00144ff88e88 63868-719 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130924 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 63868-720_06ac9e02-95d8-3046-e054-00144ff88e88 63868-720 HUMAN OTC DRUG Pressure Pain Cough PE ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20140521 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 63868-721_06ac9e02-9601-3046-e054-00144ff88e88 63868-721 HUMAN OTC DRUG Pressure Pain Cold PE ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20140521 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 63868-741_2c4c2222-d70b-4b5f-b8f3-24f60f7a0858 63868-741 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20100304 ANDA ANDA074916 Chain Drug Marketing Association Inc. IBUPROFEN 100 mg/5mL 63868-747_06ac9e02-95ed-3046-e054-00144ff88e88 63868-747 HUMAN OTC DRUG Pressure Pain Mucus PE ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20140521 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 63868-748_7a3ad12b-0c8e-4877-a737-d17e970941bc 63868-748 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20130531 NDA NDA021855 QUALITY CHOICE (Chain Drug Marketing Association) LOPERAMIDE HYDROCHLORIDE 2 mg/1 63868-752_a3f885ab-8205-4c5d-8eac-ec6897cdd41a 63868-752 HUMAN OTC DRUG Quality Choice Mucus Relief PE PE Guaifenesin/phenylephrine TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 63868-753_438caead-b30f-40c0-bc9a-e5c661a48df8 63868-753 HUMAN OTC DRUG Quality Choice Mucus Relief DM DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 63868-756_2c4c2222-d70b-4b5f-b8f3-24f60f7a0858 63868-756 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20061009 ANDA ANDA074916 Chain Drug Marketing Association Inc. IBUPROFEN 100 mg/5mL 63868-758_2c4c2222-d70b-4b5f-b8f3-24f60f7a0858 63868-758 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20080110 ANDA ANDA074916 Chain Drug Marketing Association Inc. IBUPROFEN 100 mg/5mL 63868-759_b52b3012-70f3-4364-9a89-9dfa01cb4746 63868-759 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130311 ANDA ANDA078682 QUALITY CHOICE (Chain Drug Marketing Association) IBUPROFEN 200 mg/1 63868-763_69f6b401-b462-4869-8669-c39d822fede3 63868-763 HUMAN OTC DRUG Quality Choice Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20131118 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 63868-764_11a4e861-421b-4f58-8f09-0aa1e2178973 63868-764 HUMAN OTC DRUG Quality Choice Nighttime Severe Cold and Cough Honey Lemon infused with Chamomile and White Tea Flavors Acetaminophen, Diphenhydramine HCl and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20131202 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 63868-765_2b962f55-30bf-4fd8-b391-8d8057ea0320 63868-765 HUMAN OTC DRUG Quality Choice Cold and Sore Throat Lemon Flavor Acetaminophen, Pheniramine Maleate, Phenylephrine HCl GRANULE, FOR SOLUTION ORAL 20130725 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 20; 10 mg/1; mg/1; mg/1 63868-772_06a826d2-da21-2dd8-e054-00144ff8d46c 63868-772 HUMAN OTC DRUG Rest Simply DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20140613 OTC MONOGRAPH FINAL part338 Chain Drug Marketing Association DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63868-773_eef7d180-85bb-4016-8b02-1b49fd04f931 63868-773 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 CHAIN DRUG MARKETING ASSOCIATION INC IBUPROFEN 200 mg/1 63868-774_2c4c2222-d70b-4b5f-b8f3-24f60f7a0858 63868-774 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20141010 ANDA ANDA074916 Chain Drug Marketing Association Inc. IBUPROFEN 100 mg/5mL 63868-787_b84dbe16-0d51-4001-8167-b089cb7dcfa3 63868-787 HUMAN OTC DRUG MILK OF MAGNESIA ORIGINAL magnesium hydroxide LIQUID ORAL 20140401 OTC MONOGRAPH NOT FINAL part334 Chain Drug Marketing Association MAGNESIUM HYDROXIDE 1200 mg/15mL 63868-788_367011e8-52f8-4043-a7e4-6fa5957562f8 63868-788 HUMAN OTC DRUG MILK OF MAGNESIA MINT magnesium hydroxide LIQUID ORAL 20140401 OTC MONOGRAPH NOT FINAL part334 Chain Drug Marketing Association MAGNESIUM HYDROXIDE 1200 mg/15mL 63868-790_06a92a2e-9b9c-2a7c-e054-00144ff88e88 63868-790 HUMAN OTC DRUG Ibuprofen IB Ibuprofen TABLET, COATED ORAL 20070511 ANDA ANDA091355 Chain Drug Marketing Association IBUPROFEN 200 mg/1 63868-791_06a92a2e-9bb0-2a7c-e054-00144ff88e88 63868-791 HUMAN OTC DRUG Ibuprofen IB Ibuprofen TABLET, COATED ORAL 20070511 ANDA ANDA091355 Chain Drug Marketing Association IBUPROFEN 200 mg/1 63868-792_06ac99ec-0f30-61ed-e054-00144ff8d46c 63868-792 HUMAN OTC DRUG Severe Allergy Relief Plus Sinus Headache ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20120222 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 63868-793_06a92a2e-9bdc-2a7c-e054-00144ff88e88 63868-793 HUMAN OTC DRUG Ibuprofen IB Ibuprofen TABLET, COATED ORAL 20140514 ANDA ANDA091355 Chain Drug Marketing Association IBUPROFEN 200 mg/1 63868-794_06a92a2e-9bc8-2a7c-e054-00144ff88e88 63868-794 HUMAN OTC DRUG Ibuprofen IB Ibuprofen TABLET, COATED ORAL 20140514 ANDA ANDA091355 Chain Drug Marketing Association IBUPROFEN 200 mg/1 63868-803_9f2931c0-028c-43e2-8301-37836e277193 63868-803 HUMAN OTC DRUG Night Time Cherry Pseudo-Free NyQuil Cherry LIQUID ORAL 20090304 OTC MONOGRAPH FINAL part341 Quality Choice ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 63868-807_226572fa-1fec-47e2-b41f-f1169c227607 63868-807 HUMAN OTC DRUG Night Time Cough Cherry Vicks NyQuil LIQUID ORAL 20131028 OTC MONOGRAPH FINAL part341 Quality Choice ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 63868-807_ff92b178-c011-422f-8bf6-cddf9c0f2394 63868-807 HUMAN OTC DRUG Night Time Cough Cherry Vicks NyQuil LIQUID ORAL 20131028 OTC MONOGRAPH FINAL part341 Quality Choice ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 63868-811_f4e27122-621a-49da-bedb-55c5b153e648 63868-811 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140831 OTC MONOGRAPH NOT FINAL part356 QUALITY CHOICE (Chain Drug Marketing Association) PHENOL 1.4 g/100mL 63868-812_6f30f4b7-1d8b-4e4c-9ae9-ba114d7855d3 63868-812 HUMAN OTC DRUG Sore Throat Menthol Phenol LIQUID ORAL 20140831 OTC MONOGRAPH NOT FINAL part356 QUALITY CHOICE (Chain Drug Marketing Association) PHENOL 1.4 g/100mL 63868-823_77ec448b-fdf0-4909-95cc-4bb28c16fd48 63868-823 HUMAN OTC DRUG Childrens Allergy Diphenhydramine HCl LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 63868-833_06a826d2-da11-2dd8-e054-00144ff8d46c 63868-833 HUMAN OTC DRUG Allergy Relief CHLORPHENIRAMINE MALEATE TABLET, COATED ORAL 20141001 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association CHLORPHENIRAMINE MALEATE 4 mg/1 63868-846_d1db9f3a-b54d-4e10-84f4-626804fcf489 63868-846 HUMAN OTC DRUG Tussin DM Sugar Free Non Drowsy Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 63868-855_10737ff1-e1c6-404b-a637-a24785d32985 63868-855 HUMAN OTC DRUG Tussin DM Sugar Free Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140530 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 63868-857_99722a92-2eb5-4951-8b88-56664372b2b1 63868-857 HUMAN OTC DRUG Tussin Non Drowsy Guaifenesin LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) GUAIFENESIN 100 mg/5mL 63868-865_b4feed95-86ca-411c-99b5-773e485e752f 63868-865 HUMAN OTC DRUG CHILDRENS ALLERGY RELIEF Cetirizine Hydrochloride SOLUTION ORAL 20141120 ANDA ANDA090750 C.D.M.A., Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL 63868-866_4e3e8c29-7f58-4fac-99be-e049bc859b2e 63868-866 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20140910 OTC MONOGRAPH NOT FINAL part343 C.D.M.A., Inc. ACETAMINOPHEN 160 mg/5mL 63868-867_6af76d58-3733-485e-8e2d-d8de4954fed2 63868-867 HUMAN OTC DRUG Childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 20140910 OTC MONOGRAPH FINAL part341 C.D.M.A., Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 63868-868_4b2c90ba-eeb1-4400-bd43-bbd800f5491a 63868-868 HUMAN OTC DRUG Tussin DM Cough and Chest Congestion Non Drowsy Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140930 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 63868-898_ca0b3949-c9be-4d53-91f4-a8e7d6a04476 63868-898 HUMAN OTC DRUG Enteric Aspirin Aspirin TABLET ORAL 19921214 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ASPIRIN 325 mg/1 63868-903_5c244459-f20e-48e8-bda3-d92baa021a66 63868-903 HUMAN OTC DRUG QUALITY CHOICE ORIGINAL EYE DROPS TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20120930 OTC MONOGRAPH FINAL part349 CHAIN DRUG MARKETING ASSOCIATION INC TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 63868-910_462d75cf-2904-4b3e-b3c1-6c573cb5c189 63868-910 HUMAN OTC DRUG Quality Choice Maximum Strength Triple Antibiotic Bacitracin Zinc, Neomycin, Polymyxin B Sulfate, Pramoxine Hydrochloride OINTMENT TOPICAL 20140325 OTC MONOGRAPH FINAL part333B Chain Drug Marketing Association Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 63868-925_998be22f-457e-41f0-b7dc-b642c0ff3743 63868-925 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A QUALITY CHOICE (Chain Drug Marketing Association) ISOPROPYL ALCOHOL 70 mL/100mL 63868-926_7ff8a927-9149-4207-8756-8b7b445a3f54 63868-926 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part356 QUALITY CHOICE (Chain Drug Marketing Association) HYDROGEN PEROXIDE 2.65 mL/100mL 63868-927_6a11731d-7312-43d1-b7b1-c88ae2b56df3 63868-927 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20140731 OTC MONOGRAPH FINAL part347 QUALITY CHOICE (Chain Drug Marketing Association) WITCH HAZEL 842 mg/mL 63868-933_eb2a276b-370d-4cef-b1db-30f70ba05f56 63868-933 HUMAN OTC DRUG Isopropyl alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part333A QUALITY CHOICE (Chain Drug Marketing Association) ISOPROPYL ALCOHOL 91 mL/100mL 63868-934_a18f5744-c377-43d0-9984-e28bdd8cf499 63868-934 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20140630 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) MAGNESIUM CITRATE 1.745 g/29.6mL 63868-935_ecec716a-20be-4748-be4a-6741251bb067 63868-935 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20140630 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) MAGNESIUM CITRATE 1.745 g/29.6mL 63868-936_62f4badd-e0ab-47b1-b001-d727dc121944 63868-936 HUMAN OTC DRUG Isopropyl alcohol 70 percent Wintergreen Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A QUALITY CHOICE (Chain Drug Marketing Association) ISOPROPYL ALCOHOL 70 mL/100mL 63868-938_72174817-481d-4765-bb3a-5c6fb6b8b156 63868-938 HUMAN OTC DRUG Mineral oil Mineral oil OIL ORAL 20140731 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) MINERAL OIL 100 mg/100mL 63868-939_507ae109-b13a-4af8-99b7-87807deb5af5 63868-939 HUMAN OTC DRUG Isopropyl alcohol 50 percent Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A QUALITY CHOICE (Chain Drug Marketing Association) ISOPROPYL ALCOHOL 50 mL/100mL 63868-945_77e0cd5d-ee86-4a22-bb22-953136742c9c 63868-945 HUMAN OTC DRUG QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE OINTMENT TOPICAL 20120209 OTC MONOGRAPH FINAL part333B CHAIN DRUG MARKETING ASSOCIATION INC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 63868-947_53c9d44d-7fd1-4aaa-89d7-2fa8c10e26ad 63868-947 HUMAN OTC DRUG QUALITY CHOICE EXTRA STRENGTH ANTI ITCH DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20120213 OTC MONOGRAPH FINAL part336 CHAIN DRUG MARKETING ASSOCIATION INC DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 63868-951_49aae62f-d4e8-4470-8600-da4df73aa5ac 63868-951 HUMAN OTC DRUG QUALITY CHOICE HEMORRHOIDAL MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL OINTMENT TOPICAL 20120301 OTC MONOGRAPH FINAL part346 CHAIN DRUG MARKETING ASSOCIATION INC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 140; 719; 2.5; 30 mg/g; mg/g; mg/g; mg/g 63868-953_7ab086a1-dc03-411f-a2e6-ab1211ec9ba1 63868-953 HUMAN OTC DRUG Quality Choice Maximum Strength Oral Pain Relieving BENZOCAINE GEL TOPICAL 20130531 OTC MONOGRAPH NOT FINAL part356 Chain Drug Marketing Association Inc BENZOCAINE 20 g/100g 63868-960_11330edc-236e-4888-a871-8dbbaa4845c9 63868-960 HUMAN OTC DRUG QUALITY CHOICE BACITRACIN BACITRACIN OINTMENT TOPICAL 20120213 OTC MONOGRAPH FINAL part333B CHAIN DRUG MARKETING ASSOCIATION INC BACITRACIN 500 [USP'U]/g 63868-965_04670d1a-665d-4fb2-813e-9a09e205cf5d 63868-965 HUMAN OTC DRUG Quality Choice Vaginal Anti-Itch Maximum Strength Benzocaine and Resorcinol CREAM TOPICAL 20140428 OTC MONOGRAPH NOT FINAL part348 Chain Drug Marketing Association (CDMA) BENZOCAINE; RESORCINOL 200; 30 mg/g; mg/g 63868-966_113e489c-c3a6-4ffe-8138-8f9cdbe08262 63868-966 HUMAN OTC DRUG Allerfed Cold and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20050722 OTC MONOGRAPH FINAL part341 CHAIN DRUG MARKETING ASSOCIATION INC CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 63868-967_eadfb65d-e5e5-4913-a411-205b9587310d 63868-967 HUMAN OTC DRUG QUALITY CHOICE LUBRICANT TEARS EYE GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 SOLUTION/ DROPS OPHTHALMIC 20120930 OTC MONOGRAPH FINAL part349 CHAIN DRUG MARKETING ASSOCIATION INC GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2; 2; 10 mg/mL; mg/mL; mg/mL 63868-968_0e4d5583-a1fa-4792-b8af-7a7846d8bec9 63868-968 HUMAN OTC DRUG QUALITY CHOICE LUBRICANT EYE POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL SOLUTION/ DROPS OPHTHALMIC 20120930 OTC MONOGRAPH FINAL part349 CHAIN DRUG MARKETING ASSOCIATION INC POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL 63868-969_50918b6e-da18-4610-9622-5f061fe14a10 63868-969 HUMAN OTC DRUG QUALITY CHOICE LUBRICATING EYE DROPS CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN SOLUTION OPHTHALMIC 20120930 OTC MONOGRAPH FINAL part349 CHAIN DRUG MARKETING ASSOCIATION INC CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL 63868-971_06a92a2e-9c17-2a7c-e054-00144ff88e88 63868-971 HUMAN OTC DRUG Pressure and Pain PE ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20070829 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 63868-972_06ac9e02-95c4-3046-e054-00144ff88e88 63868-972 HUMAN OTC DRUG Sinus Relief ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20071009 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 63868-974_b9dbe835-eb53-4c51-b6eb-50c57d939bbb 63868-974 HUMAN OTC DRUG Clotrimazole Antifungal clotrimazole CREAM TOPICAL 20070829 OTC MONOGRAPH FINAL part333C Chain Drug Marketing Association Inc. CLOTRIMAZOLE 10 mg/g 63868-976_066f3051-06f6-62ea-e054-00144ff8d46c 63868-976 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, COATED ORAL 20140521 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 63868-977_d9703483-42bd-49a0-8da7-91e6011b8d08 63868-977 HUMAN OTC DRUG Quality Choice Ibuprofen 200 Ibuprofen TABLET ORAL 20140723 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association IBUPROFEN 200 mg/1 63868-978_0d58dfa3-1dd3-4074-ad83-3aae6b6bb5f0 63868-978 HUMAN OTC DRUG Quality Choice Extra Strength Pain Relief Acetaminophen TABLET ORAL 20140823 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ACETAMINOPHEN 500 mg/1 63868-979_8f2bdca3-9586-4909-b41d-a086d3d745be 63868-979 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 CHAIN DRUG MARKETING ASSOCIATION INC IBUPROFEN 200 mg/1 63868-980_f13f9c71-6ffd-4501-afbe-a5ab81e6c9e0 63868-980 HUMAN OTC DRUG Sterile Alcohol Isopropyl alcohol SWAB TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part333A Chain Drug Marketing Association Inc ISOPROPYL ALCOHOL .7 mL/1 63868-981_06ac9e02-9586-3046-e054-00144ff88e88 63868-981 HUMAN OTC DRUG Allergy Multi-Symptom ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20080801 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 63868-983_06ba032d-b59b-115f-e054-00144ff88e88 63868-983 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20120827 ANDA ANDA079129 Chain Drug Marketing Association IBUPROFEN 200 mg/1 63868-984_06a92a2e-9c2b-2a7c-e054-00144ff88e88 63868-984 HUMAN OTC DRUG Sinus Congestion and Pain ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20070829 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 63868-985_06ac99ec-0f1c-61ed-e054-00144ff8d46c 63868-985 HUMAN OTC DRUG Allergy Relief Plus Sinus Headache Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20071128 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 63868-987_2802779e-12fc-476c-a8c1-8caeefcb85a4 63868-987 HUMAN OTC DRUG Extra Strength Non-Aspirin Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ACETAMINOPHEN 500 mg/1 63868-995_69610b3f-f3cf-41bf-af1b-e26e8e0fe670 63868-995 HUMAN OTC DRUG Dye-Free Allergy Relief Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20010913 OTC MONOGRAPH FINAL part341 CHAIN DRUG MARKETING ASSOCIATION INC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63868-998_14646797-4241-40a6-a025-4be29a4d803b 63868-998 HUMAN OTC DRUG Quality Choice Mucus Relief Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association GUAIFENESIN 400 mg/1 63870-583_755ec181-cd9b-4fa1-a4e0-acd5ad9b5aeb 63870-583 HUMAN OTC DRUG Simply b, MD Daily Clear Titanium dioxide, Zinc Oxide LOTION TOPICAL 20140422 OTC MONOGRAPH FINAL part352 KDT Enterprises, LLC dba Simply B, MD TITANIUM DIOXIDE; ZINC OXIDE 5; 6.6 g/100mL; g/100mL 63874-087_12c7793d-11c5-4f1b-883b-04e7aed3fb5c 63874-087 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20100101 ANDA ANDA076286 Altura Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 63874-101_2234ef41-dd5f-46b3-aa17-8f8fd30add38 63874-101 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20100101 ANDA ANDA065291 Altura Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 63874-102_2234ef41-dd5f-46b3-aa17-8f8fd30add38 63874-102 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20100101 ANDA ANDA065291 Altura Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 63874-111_b4cebeeb-b014-4e9d-a865-4f09e4473c36 63874-111 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20100101 ANDA ANDA065215 Altura Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 63874-112_b4cebeeb-b014-4e9d-a865-4f09e4473c36 63874-112 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20100101 ANDA ANDA065215 Altura Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 63874-201_1f96e42a-9915-49d9-8971-7d72ec6db64f 63874-201 HUMAN PRESCRIPTION DRUG Propoxyphene and Acetaminophen propoxyphene napsylate and acetaminophen TABLET, FILM COATED ORAL 20100101 ANDA ANDA074843 Altura Pharmaceuticals, Inc. ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 650; 100 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 63874-203_4861231c-7aeb-49d5-9309-4e2855039a78 63874-203 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20100101 ANDA ANDA089971 Altura Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63874-230_4861231c-7aeb-49d5-9309-4e2855039a78 63874-230 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20100101 ANDA ANDA040157 Altura Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63874-279_4861231c-7aeb-49d5-9309-4e2855039a78 63874-279 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20100101 ANDA ANDA040358 Altura Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 660; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63874-293_4861231c-7aeb-49d5-9309-4e2855039a78 63874-293 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20100101 ANDA ANDA040356 Altura Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63874-295_4861231c-7aeb-49d5-9309-4e2855039a78 63874-295 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20100101 ANDA ANDA040144 Altura Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63874-301_feb7a143-ac2f-48fd-a2d1-1475337efacf 63874-301 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100101 ANDA ANDA078250 Altura Pharmaceuticals, Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63874-322_1fbfeaff-19c8-4475-8da3-7e556c7e9104 63874-322 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100101 ANDA ANDA078558 Altura Pharmaceuticals, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63874-323_1fbfeaff-19c8-4475-8da3-7e556c7e9104 63874-323 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100101 ANDA ANDA078558 Altura Pharmaceuticals, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63874-324_1fbfeaff-19c8-4475-8da3-7e556c7e9104 63874-324 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100101 ANDA ANDA078558 Altura Pharmaceuticals, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63874-325_feb7a143-ac2f-48fd-a2d1-1475337efacf 63874-325 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100101 ANDA ANDA078250 Altura Pharmaceuticals, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63874-326_feb7a143-ac2f-48fd-a2d1-1475337efacf 63874-326 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100101 ANDA ANDA078250 Altura Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63874-339_feb7a143-ac2f-48fd-a2d1-1475337efacf 63874-339 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20100101 ANDA ANDA078314 Altura Pharmaceuticals, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63874-413_66fa987f-47df-49ff-ab90-8b1e2bd3319c 63874-413 HUMAN PRESCRIPTION DRUG Methylprednisolone methylprednisolone TABLET ORAL 20100101 NDA NDA011757 Altura Pharmaceuticals, Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 63874-489_feb7a143-ac2f-48fd-a2d1-1475337efacf 63874-489 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20100101 ANDA ANDA078314 Altura Pharmaceuticals, Inc. NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63874-532_48b18a1e-404e-4b1e-b539-94d6993c8a76 63874-532 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20100101 ANDA ANDA076003 Altura Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 63874-553_094625fc-2d69-4268-8c79-7519eafe1051 63874-553 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20100101 ANDA ANDA075410 Altura Pharmaceuticals, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 63874-607_c445da39-f7f2-46a9-871f-a25f1c0f462f 63874-607 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20100101 ANDA ANDA076009 Altura Pharmaceuticals, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63874-687_c445da39-f7f2-46a9-871f-a25f1c0f462f 63874-687 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20100101 ANDA ANDA076009 Altura Pharmaceuticals, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 63874-834_4861231c-7aeb-49d5-9309-4e2855039a78 63874-834 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20100101 ANDA ANDA040355 Altura Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63874-861_4861231c-7aeb-49d5-9309-4e2855039a78 63874-861 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20100101 ANDA ANDA040143 Altura Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 63917-001_06c65b8d-2b1d-414f-af88-cee1ae547a03 63917-001 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20091229 NDA NDA205846 Airgas Carbonic, Inc. CARBON DIOXIDE 1000 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 63922-222_2be7ff9e-918c-4424-95e9-8f74f79b1f37 63922-222 HUMAN OTC DRUG Sun Moon Star Pain Relieving Menthol Methyl Salicylate PATCH TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part348 Kingsway Trading MENTHOL; METHYL SALICYLATE 16; 15 g/1; g/1 63922-600_728cbd00-b190-41ef-a848-7d8766e5d878 63922-600 HUMAN OTC DRUG Ganmaoling 999 Acetaminophen Caffeine Chlorpheniramine Maleate GRANULE ORAL 20120630 OTC MONOGRAPH FINAL part341 Kingsway Trading ACETAMINOPHEN; CAFFEINE; CHLORPHENIRAMINE MALEATE 200; 4; 4 mg/1; mg/1; mg/1 63922-601_db0a71dd-c5fa-4580-b085-9895586d953a 63922-601 HUMAN OTC DRUG 999 GANMAOLING Cold Acetaminophen Caffeine Chlorpheniramine Maleate CAPSULE ORAL 20120730 OTC MONOGRAPH FINAL part341 Kingsway ACETAMINOPHEN; CAFFEINE; CHLORPHENIRAMINE MALEATE 100; 2; 2 mg/1; mg/1; mg/1 63922-605_dc8d6626-3092-43cb-94c8-a2a02d4b321b 63922-605 HUMAN OTC DRUG KGS ALLERGY SOOTHING Acetaminophen Chlorpheniramine Maleate CAPSULE, DELAYED RELEASE PELLETS ORAL 20140130 OTC MONOGRAPH FINAL part341 Kingsway ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 250; 2 mg/1; mg/1 63936-8504_39130cfa-97ce-4fa5-891f-42aec5f5567e 63936-8504 HUMAN OTC DRUG EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING MENTHOL SPRAY TOPICAL 20101013 OTC MONOGRAPH NOT FINAL part348 TROY MANUFACTURING, INC MENTHOL 8 mL/100mL 63936-8508_94dbc81a-8af6-4d72-a29e-6b411c6becc4 63936-8508 HUMAN OTC DRUG ULTRA STRENGTH STOPAIN PAIN RELIEVING MENTHOL SPRAY TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part348 TROY MANUFACTURING MENTHOL 8 mL/100mL 63936-8523_1d87acef-9832-4616-bf82-41188d6770a1 63936-8523 HUMAN OTC DRUG EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON MENTHOL LIQUID TOPICAL 20101013 OTC MONOGRAPH NOT FINAL part348 TROY MANUFACTURING, INC MENTHOL 8 mL/100mL 63936-8558_8ec6d844-d418-49b8-8755-6138e8d77989 63936-8558 HUMAN OTC DRUG STOPAIN COLD PAIN RELIEVING MENTHOL SPRAY TOPICAL 20101013 OTC MONOGRAPH NOT FINAL part348 TROY MANUFACTURING, INC MENTHOL 6 mL/100mL 63936-8582_2cdb6331-c62a-437e-8f83-ef19766f62d5 63936-8582 HUMAN OTC DRUG STOPAIN COLD PAIN RELIEVING MENTHOL GEL TOPICAL 20101203 OTC MONOGRAPH FINAL part348 Troy Manufacturing, Inc. MENTHOL 6 g/100g 63936-8750_34cacb79-b481-4583-8500-c3e0ea891c7e 63936-8750 HUMAN OTC DRUG Stopain Cold Professional Strength Pain Relieving MENTHOL GEL TOPICAL 20140703 OTC MONOGRAPH NOT FINAL part348 TROY MANUFACTURING, INC MENTHOL 80 mg/g 63940-000_b4420c1e-7312-453e-99c4-ee0af0a58d98 63940-000 HUMAN OTC DRUG Harmon Face Values Daily Facial Avobenzone and Octocrylene CREAM TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part352 Harmon Stores Inc. AVOBENZONE; OCTOCRYLENE 3; 10 mL/100mL; mL/100mL 63940-020_a7cfdd37-8b4e-42ee-83d0-ea436b7a8f34 63940-020 HUMAN OTC DRUG Diaper Rash Zinc oxide PASTE TOPICAL 20130305 OTC MONOGRAPH FINAL part347 Harmon Stores, Inc ZINC OXIDE 532 mg/g 63940-055_a143c5ec-932a-43b1-b1bf-2c4ee85809a7 63940-055 HUMAN OTC DRUG FACE VALUES FRESH SCENT Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Harmon Stores Inc. BENZALKONIUM CHLORIDE .115 g/1 63940-069_90f15187-c4e0-49f8-8ab3-14c9ef302036 63940-069 HUMAN OTC DRUG Petrolatum White Petrolatum JELLY TOPICAL 19930316 OTC MONOGRAPH FINAL part347 Harmon Stores, Inc PETROLATUM 1 g/g 63940-072_fa2230f3-37f0-4069-93e7-923c99c97034 63940-072 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19951009 OTC MONOGRAPH NOT FINAL part356 Harmon Stores Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 63940-100_be9a8ace-4619-4aad-84f5-377b129bdeff 63940-100 HUMAN OTC DRUG HARMON Extra Strength Pain Relieving MENTHOL GEL TOPICAL 20120905 OTC MONOGRAPH FINAL part348 Harmon Stores Inc. MENTHOL 3.5 mL/100mL 63940-101_86d2ce60-0d7f-4c5b-bf3f-09b1dd181863 63940-101 HUMAN OTC DRUG harmon face values allergy relief Loratadine TABLET ORAL 20111218 ANDA ANDA076301 Harmon Stores Inc. LORATADINE 10 mg/1 63940-121_91280594-08bc-4d09-9346-3ea9d93bf1dc 63940-121 HUMAN OTC DRUG Face Values - AM Facial Moisturizing Broad Spectrum SPF30 Sunscreen Homosalate, Octinoxate, Octocrylene, Zinc Oxide LOTION TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part352 Harmon Stores Inc HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 12; 7.5; 2; 3.5 g/100mL; g/100mL; g/100mL; g/100mL 63940-150_73ea9d17-16a8-46af-b6dc-13f678a7b2dc 63940-150 HUMAN OTC DRUG HARMON Extra Strength Pain Relieving Roll-On MENTHOL GEL TOPICAL 20120905 OTC MONOGRAPH FINAL part348 Harmon Stores Inc. MENTHOL 3.5 mL/100mL 63940-175_d867ea4a-a0e3-4303-bbf3-7263a5fdc0a8 63940-175 HUMAN OTC DRUG harmon face values pain and fever Acetaminophen SUSPENSION ORAL 20111218 OTC MONOGRAPH NOT FINAL part343 Harmon Stores Inc. ACETAMINOPHEN 160 mg/5mL 63940-199_303663e6-b1c8-469f-8491-c509917d333a 63940-199 HUMAN OTC DRUG Ibuprofen IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20140831 ANDA ANDA078682 Harmon Stores IBUPROFEN 200 mg/1 63940-202_c9c33ff8-ad50-4f5b-a171-7243db072c12 63940-202 HUMAN OTC DRUG harmon face values minoxidil minoxidil SOLUTION TOPICAL 20111218 ANDA ANDA075357 Harmon Stores Inc. MINOXIDIL 2 g/100mL 63940-224_40555c92-0968-471c-88ea-b9f0033af11f 63940-224 HUMAN OTC DRUG harmon face values anti diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20111218 ANDA ANDA075232 Harmon Stores Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 63940-226_f88ac587-4745-4374-8bde-777ee475b139 63940-226 HUMAN OTC DRUG Diaper Rash Zinc oxide CREAM TOPICAL 20130215 OTC MONOGRAPH NOT FINAL part348 Harmon Stores Inc ZINC OXIDE 130 mg/g 63940-310_74375c1e-5b18-42be-bcb7-9d85388da5f1 63940-310 HUMAN OTC DRUG Quick Wrinkle Repair Moisturizer Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part352 Harmon Stores Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 4; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL 63940-334_2e612f97-9c36-485d-95f9-02151c7c6ff6 63940-334 HUMAN OTC DRUG Harmon Face Values Daily Moisturizing Dimethicone LOTION TOPICAL 20140901 OTC MONOGRAPH FINAL part347 Harmon Stores Inc. DIMETHICONE 1.25 g/100mL 63940-335_5833528d-af0e-4d66-be40-aecce0fd1965 63940-335 HUMAN OTC DRUG harmon face values night time relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120113 OTC MONOGRAPH FINAL part341 Harmon Stores Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 63940-343_4db80eb6-0cb6-43a0-a808-ff69538dff80 63940-343 HUMAN OTC DRUG A D and L Original Diaper Rash Skin Lanolin, Petrolatum OINTMENT TOPICAL 20140901 OTC MONOGRAPH FINAL part347 Harmon Stores Inc. LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g 63940-359_2342e811-1761-4b1f-bf59-d9c0f0fbe734 63940-359 HUMAN OTC DRUG Harmon Face Values Tussin DM Adult Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20111218 OTC MONOGRAPH FINAL part341 Harmon Stores Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 63940-387_842023b8-3587-4c51-8324-75d02e2ad6ed 63940-387 HUMAN OTC DRUG Harmon Face Values Revitalizing Day Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part352 Harmon Stores Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 5 g/100g; g/100g; g/100g 63940-429_970acac2-e16d-4d78-9570-37064147b250 63940-429 HUMAN OTC DRUG Baby Eczema Moisturizing Colloidal Oatmeal CREAM TOPICAL 20140901 OTC MONOGRAPH FINAL part347 Harmon Stores Inc. OATMEAL 1 g/100g 63940-433_28b33138-2288-4e8e-aa6e-25f0dc9deffe 63940-433 HUMAN OTC DRUG Baby Daily Moisturizing Fragrance Free Dimethicone LOTION TOPICAL 20140901 OTC MONOGRAPH FINAL part347 Harmon Stores Inc. DIMETHICONE 1.2 g/100mL 63940-458_ff37978b-e38d-4d4b-af89-e1764529b0bd 63940-458 HUMAN OTC DRUG harmon face values allergy relief Cetirizine Hydrochloride TABLET ORAL 20111218 ANDA ANDA078336 Harmon Stores Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 63940-459_33989eef-2d70-4fa0-b3fa-df274dd4feb2 63940-459 HUMAN OTC DRUG harmon face values night time relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120223 OTC MONOGRAPH FINAL part341 Harmon Stores Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 63940-472_653c1abf-a2e4-4d71-903d-bd16c1625b29 63940-472 HUMAN OTC DRUG Harmon Revitalizing Facial Smoother Immediate Skin Smoothing Finishing Broad Spectrum SPF30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 Harmon Stores Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 63940-516_e5d9f411-fd89-44b8-b19a-7bd031272c52 63940-516 HUMAN OTC DRUG harmon face values tussin cf Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20111218 OTC MONOGRAPH FINAL part341 Harmon Stores Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL 63940-536_06f7c9ac-1abe-4d75-90e2-2f1a70aaae23 63940-536 HUMAN OTC DRUG Oil-Free Acne Wash Salicylic Acid SOLUTION TOPICAL 20131115 OTC MONOGRAPH FINAL part333D Harmon Stores Inc SALICYLIC ACID 2 g/100mL 63940-540_aa640014-bbec-4513-8cef-36b61a0682b7 63940-540 HUMAN OTC DRUG FACE VALUES BACITRACIN BACITRACIN OINTMENT TOPICAL 20120401 OTC MONOGRAPH FINAL part333B HARMON STORES INC. BACITRACIN 500 [USP'U]/g 63940-541_a9e4932f-9770-452c-a209-76521d1b762a 63940-541 HUMAN OTC DRUG FACE VALUES HYDROCORTISONE WITH ALOE HYDROCORTISONE CREAM TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part348 HARMON STORES INC. HYDROCORTISONE 1 g/100g 63940-542_e9535995-a73c-4c33-aae6-a700619885bd 63940-542 HUMAN OTC DRUG FACE VALUES TRIPLE ANTIBIOTIC BACITRACIN, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE OINTMENT TOPICAL 20120401 OTC MONOGRAPH FINAL part333B HARMON STORES INC. BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 63940-590_0a886995-389d-4a5c-951d-be0dbad815a7 63940-590 HUMAN OTC DRUG harmon face values pain and fever acetaminophen LIQUID ORAL 20120417 OTC MONOGRAPH NOT FINAL part343 Harmon Stores Inc. ACETAMINOPHEN 160 mg/5mL 63940-610_5b495112-72b7-4a21-9b0c-b4a60b5c56c1 63940-610 HUMAN OTC DRUG Harmon Face Values Pomegranate Scent Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130823 OTC MONOGRAPH NOT FINAL part333A Harmon Stores Inc. ALCOHOL 62 mL/100mL 63940-611_45a36bc3-cd8a-4d98-983a-36d8d459f7d6 63940-611 HUMAN OTC DRUG Harmon Face Values Cucumber Melon Scent Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130823 OTC MONOGRAPH NOT FINAL part333A Harmon Stores Inc. ALCOHOL 62 mL/100mL 63940-613_7455a890-aa60-4b86-ada3-4d8fe918b78a 63940-613 HUMAN OTC DRUG Harmon Face Values Warm Vanilla Sugar Scent Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130823 OTC MONOGRAPH NOT FINAL part333A Harmon Stores Inc. ALCOHOL 62 mL/100mL 63940-614_680543ae-6a81-47c6-863d-c021702a2abc 63940-614 HUMAN OTC DRUG Harmon Face Values Cherry Blossom Scent Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130823 OTC MONOGRAPH NOT FINAL part333A Harmon Stores Inc. ALCOHOL 62 mL/100mL 63940-641_80971605-f6ae-4b3d-9472-58f58cc63f92 63940-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Harmon Stores, Inc BENZALKONIUM CHLORIDE .999 mg/mL 63940-664_4abae57c-a5be-4e7b-aeb8-d2fa8a9c3aeb 63940-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19930521 OTC MONOGRAPH NOT FINAL part356 Harmon Stores Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 63940-688_84c99be9-5743-494c-86c4-4a3f4091d045 63940-688 HUMAN OTC DRUG Harmon Face Values Revitalizing Age Control Anti-Sagging Ultra Hydrating Day SPF 15 Ensulizole and Octinoxate CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Harmon Stores Inc. ENSULIZOLE; OCTINOXATE 1.7; 7.5 g/100g; g/100g 63940-798_7dbf1960-c6aa-488d-9c94-0eedb5b8312c 63940-798 HUMAN OTC DRUG harmon face values minoxidil Minoxidil SOLUTION TOPICAL 20111218 ANDA ANDA075598 Harmon Stores Inc. MINOXIDIL 3 g/60mL 63940-802_85d20f19-0ac1-4d2d-843f-87c695877f05 63940-802 HUMAN OTC DRUG HARMON FACE VALUES MEDICATED WIPES WITCH HAZEL CLOTH TOPICAL 20120731 OTC MONOGRAPH FINAL part346 HARMON STORES INC. WITCH HAZEL 5 g/1 63940-803_6a650e0c-1d83-4594-9eed-d8ae48365c22 63940-803 HUMAN OTC DRUG Harmon Face Values Medicated Witch Hazel SOLUTION RECTAL; TOPICAL 20130823 OTC MONOGRAPH FINAL part346 Harmon Stores Inc. WITCH HAZEL .5 mg/mg 63940-897_14b8890d-237a-4203-bc4c-c08df4441ba6 63940-897 HUMAN OTC DRUG harmon face values ibuprofen Ibuprofen SUSPENSION ORAL 20111218 ANDA ANDA074937 Harmon Stores Inc. IBUPROFEN 100 mg/5mL 63940-915_b0ee8425-754a-4c31-ad51-c8cb691f0a88 63940-915 HUMAN OTC DRUG harmon face values omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20111218 NDA NDA022032 Harmon Stores Inc. OMEPRAZOLE 20 mg/1 63941-001_fdff1bbd-4d1b-4471-b5f4-db3297958b56 63941-001 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19950609 OTC MONOGRAPH NOT FINAL part356 Valu Merchandisers Co. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 63941-002_843d077e-993f-4268-8ddc-31fe44594427 63941-002 HUMAN OTC DRUG Stool Softener plus Stimulant Laxative Docusate sodium and Sennosides TABLET ORAL 20100915 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 63941-003_9309a4ab-fd8d-46d7-95a7-589309c32e26 63941-003 HUMAN OTC DRUG Antiseptic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19950609 OTC MONOGRAPH NOT FINAL part356 Valu Merchandisers Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 63941-004_9f2de99c-48aa-4cce-b7cd-269f6f43ace8 63941-004 HUMAN OTC DRUG Antacid Antigas Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone SUSPENSION ORAL 20090408 OTC MONOGRAPH FINAL part331 Best Choice ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 63941-007_0feac822-2bcf-42f1-973a-03989cbbd063 63941-007 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090116 OTC MONOGRAPH NOT FINAL part333A Best Choice (Valu Merchandisers Company) ISOPROPYL ALCOHOL 70 mL/100mL 63941-008_a6691c34-1114-4edd-b458-543b42f40911 63941-008 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20141016 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers Co. ALCOHOL 70 mL/100mL 63941-016_1a1243b7-14f2-4061-8195-5a53d21a07e1 63941-016 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090203 OTC MONOGRAPH FINAL part335 Best Choice BISMUTH SUBSALICYLATE 262 mg/15mL 63941-018_f71c5873-d965-4037-80d8-c0e8532e63ab 63941-018 HUMAN OTC DRUG Tussin DM Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20090707 OTC MONOGRAPH FINAL part341 Best Choice DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 63941-019_e33756ea-d37b-43b9-a996-fd50fedc8f0a 63941-019 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120430 ANDA ANDA202727 Best Choice (Valu Merchandisers Company) LANSOPRAZOLE 15 mg/1 63941-025_1c4f6e45-e24c-48f7-8e60-4a6bc7b9f470 63941-025 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20090428 OTC MONOGRAPH FINAL part341 Best Choice DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 63941-035_4998d1a6-a435-4ab4-8b14-2377ca9160c2 63941-035 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100625 ANDA ANDA090283 Valu Merchandisers Company FAMOTIDINE 10 mg/1 63941-036_4998d1a6-a435-4ab4-8b14-2377ca9160c2 63941-036 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100723 ANDA ANDA090283 Valu Merchandisers Company FAMOTIDINE 20 mg/1 63941-052_20a4fa3a-cb15-46e4-bfc3-3b779460918e 63941-052 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl TABLET ORAL 20140430 OTC MONOGRAPH FINAL part338 Best Choice (Valu Merchandisers Company) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63941-053_deb6bd98-eafb-4c34-b6ee-49bf46b4f070 63941-053 HUMAN OTC DRUG Severe Multi-Symptom Cold Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED ORAL 20050804 OTC MONOGRAPH NOT FINAL part343 VALUE MERCHANDISERS COMPANY, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 63941-055_9e8e861a-39f0-4acc-80cc-ea8a4b13cb40 63941-055 HUMAN OTC DRUG Best Choice Fresh Scent Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers Company BENZALKONIUM CHLORIDE .115 g/1 63941-060_a8a7035f-a79c-4f04-94ec-0a79093fdddb 63941-060 HUMAN OTC DRUG Minral Oil Mineral Oil OIL ORAL; TOPICAL 20090416 OTC MONOGRAPH NOT FINAL part334 Best Choice MINERAL OIL 15 mL/15mL 63941-072_ef429caf-a162-4490-ab8d-198beadd05eb 63941-072 HUMAN OTC DRUG Night Time Cough DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20100107 OTC MONOGRAPH FINAL part341 Best Choice DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 135 mg/15mL; mg/5mL 63941-078_fc283167-8f51-40e2-be25-7b716973ee04 63941-078 HUMAN OTC DRUG Milk of Magnesia Original MAGNESIUM HYDROXIDE SUSPENSION ORAL 20090402 OTC MONOGRAPH FINAL part334 Best Choice MAGNESIUM HYDROXIDE 1200 mg/15mL 63941-079_36a68534-36b7-4bc7-9f65-5aaf0905b2fb 63941-079 HUMAN OTC DRUG Night Time Cold and Cough Childrens Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 63941-085_c74fb125-77f4-4792-825b-1271d4106349 63941-085 HUMAN OTC DRUG Best Choice Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Valu Merchandisers Company LORATADINE 5 mg/5mL 63941-088_f9f7365a-dbbd-4409-b9dd-c798bc3d5e00 63941-088 HUMAN OTC DRUG Best Choice Childrens Cetirizine Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Valu Merchandisers Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 63941-092_a5314bac-570f-40b2-a1e6-520820f72781 63941-092 HUMAN OTC DRUG Best Choice Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Valu Merchandisers Company LORATADINE 5 mg/5mL 63941-100_a439966c-10cc-4342-9ed4-c66cb371b1d5 63941-100 HUMAN OTC DRUG Tussin Sugar Free Cough Dextromethorphan Hydrobromide, GUAIFENESIN, LIQUID ORAL 20080924 OTC MONOGRAPH FINAL part341 Best Choice DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 63941-102_56cb4382-402d-4a60-8136-373305f49650 63941-102 HUMAN OTC DRUG Best Choice Childrens Cetirizine Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Valu Merchandisers Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 63941-103_46602793-0983-4e48-8212-d14289ba9844 63941-103 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20140630 OTC MONOGRAPH NOT FINAL part343 Best Choice (Valu Merchandisers Company) ASPIRIN 81 mg/1 63941-112_c4389178-8ebf-4365-80a3-11ce41828d4d 63941-112 HUMAN OTC DRUG Night Time Original Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090813 OTC MONOGRAPH FINAL part341 Best Choice ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 63941-113_aa59cdc5-5f63-4771-a67f-72bc0df4448d 63941-113 HUMAN OTC DRUG Night Time Cherry Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090813 OTC MONOGRAPH FINAL part341 Best Choice ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 63941-120_21740fb9-185a-4817-b76c-2b82eaa203ca 63941-120 HUMAN OTC DRUG womans laxative Bisacodyl TABLET ORAL 20100716 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) BISACODYL 5 mg/1 63941-121_6e5c4830-06ba-47d5-b5f4-f13ffee4d404 63941-121 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120619 ANDA ANDA202300 Valu Merchandisers Company (Best Choice) IBUPROFEN 200 mg/1 63941-123_54a246e3-9852-49d8-a07b-1b70b30d973f 63941-123 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Valu Merchandisers Company LOPERAMIDE HYDROCHLORIDE 2 mg/1 63941-124_10e35d88-4015-42cc-82ee-e4f643ca263a 63941-124 HUMAN OTC DRUG Childrens Plus Cough and Sore Throat Acetaminophen, DEXTROMETHORPHAN HYDROBROMIDE SUSPENSION ORAL 20090813 OTC MONOGRAPH FINAL part341 Best Choice ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 160 mg/5mL; mg/5mL 63941-125_4ac736f7-ca10-49c8-882f-e47f21d3bac1 63941-125 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen LIQUID ORAL 20091002 ANDA ANDA079058 Valu Merchandisers Company IBUPROFEN 50 mg/1.25mL 63941-130_66213a32-a552-4459-a58f-e7340c58748a 63941-130 HUMAN OTC DRUG Childrens Plus Cough and Runny Nose ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE SUSPENSION ORAL 20090303 OTC MONOGRAPH FINAL part341 Best Choice ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL 63941-136_3420ac27-ad17-4e88-927f-ba39c8909a52 63941-136 HUMAN OTC DRUG Peptic Relief Cherry Bismuth Subsalicylate SUSPENSION ORAL 20100108 OTC MONOGRAPH FINAL part335 Best Choice BISMUTH SUBSALICYLATE 262 mg/15mL 63941-140_206c8866-5943-48cf-88ce-0c5122fe3411 63941-140 HUMAN OTC DRUG Laxative Pills maximum strength Sennosides TABLET ORAL 20100823 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) SENNOSIDES 25 mg/1 63941-142_c1e56a08-fee6-438d-8b9f-4672e66b1588 63941-142 HUMAN OTC DRUG Day Time with PE Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20090813 OTC MONOGRAPH FINAL part341 Best Choice ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 63941-145_fdf57852-233b-4ec8-9192-5f6aee547438 63941-145 HUMAN OTC DRUG Childrens Plus Multi-Symptom Grape with PE ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE SUSPENSION ORAL 20090303 OTC MONOGRAPH FINAL part341 Best Choice ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 63941-146_bff85ea7-7534-4b74-bc6e-91cdd7fcf059 63941-146 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE ORAL 20100824 OTC MONOGRAPH NOT FINAL part334 Valu Merchandisers Company (Best Choice) DOCUSATE SODIUM 100 mg/1 63941-153_30e16744-d672-4c1a-8473-9773109e18f4 63941-153 HUMAN OTC DRUG Everyday Clean Dandruff pyrithione zinc SHAMPOO TOPICAL 19990314 OTC MONOGRAPH FINAL part358H ValueMerchandisers PYRITHIONE ZINC 10 mg/mL 63941-157_7ed223fb-a320-42a9-9727-c01b8bf1fde9 63941-157 HUMAN OTC DRUG Aspirin NSAID Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 VALUE MERCHANDISERS COMPANY, INC. ASPIRIN 325 mg/1 63941-159_209884e9-8173-4d19-8ab5-bfd172e725c9 63941-159 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 VALUE MERCHANDISERS COMPANY, INC. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 63941-161_8c039393-ca0e-4d72-8ca5-fb77ba7ae671 63941-161 HUMAN OTC DRUG Hemorrhoidal MINERAL OIL,PETROLATUM,PHENYLEPHRINE OINTMENT TOPICAL 20120206 OTC MONOGRAPH FINAL part346 Valu Merchandisers, Co. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 71.9; .25 g/100g; g/100g; g/100g 63941-164_dc48210b-89d8-41e6-9005-40322d94f00c 63941-164 HUMAN OTC DRUG Sore Throat Cherry Phenol LIQUID ORAL 20090801 OTC MONOGRAPH NOT FINAL part356 Best Choice PHENOL 1.5 g/100mL 63941-165_758c7340-4910-44f2-a5ba-0b9bc296d779 63941-165 HUMAN OTC DRUG Sore Throat Menthol Phenol LIQUID ORAL 20090801 OTC MONOGRAPH NOT FINAL part356 Best Choice (Valu Merchandisers Company) PHENOL 1.5 g/100mL 63941-166_6a81a801-fc5d-4b10-b52a-b8a3e0ad496c 63941-166 HUMAN OTC DRUG Ibuprofen PM Ibuprofen and Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20110610 ANDA ANDA090397 Valu Merchandisers Company (Best Choice) DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25; 200 mg/1; mg/1 63941-180_c62f99d0-4a12-452f-9656-5398c028f0fb 63941-180 HUMAN OTC DRUG Best Choice Senna Sennosides TABLET ORAL 20120518 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) SENNOSIDES A AND B 8.6 mg/1 63941-183_503e0e8a-a0da-4234-af99-c0f9112686de 63941-183 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20120520 OTC MONOGRAPH NOT FINAL part343 Best Choice (Valu Merchandisers Company) ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 63941-189_53a34719-467b-4244-996f-7fdf3eb7ac78 63941-189 HUMAN OTC DRUG Fexofenadine HCl Fexofenadine HCl TABLET ORAL 20120604 ANDA ANDA079112 Valu Merchandisers Company (Best Choice) FEXOFENADINE HYDROCHLORIDE 180 mg/1 63941-190_77e06924-afaa-4b7f-a4b2-c14d1250e981 63941-190 HUMAN OTC DRUG Best Choice Bisacodyl Laxative BISACODYL TABLET, COATED ORAL 20121102 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) BISACODYL 5 mg/1 63941-199_8d57097d-add8-4c0e-af9a-adccaacf4d8f 63941-199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100821 ANDA ANDA078682 Best Choice (Valu Merchandisers Company) IBUPROFEN 200 mg/1 63941-200_c22bf07a-91b2-4f43-8a18-e25ac88899d5 63941-200 HUMAN OTC DRUG Sleep original formula Diphenhydramine HCl TABLET ORAL 20100716 OTC MONOGRAPH FINAL part336 Best Choice (Valu Merchandisers Company) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63941-203_ef9972de-b016-4000-bc51-24287b320245 63941-203 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20110711 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers, CO ALCOHOL 578 mg/mL 63941-204_30be9715-2581-428f-8559-d3beb1163b31 63941-204 HUMAN OTC DRUG Antacid Antigas Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone SUSPENSION ORAL 20090408 OTC MONOGRAPH FINAL part331 Best Choice ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 200; 200 mg/5mL; mg/5mL; mg/5mL 63941-213_ad61b712-9af0-4d02-b130-e46dff409c08 63941-213 HUMAN OTC DRUG Night Time Cherry Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090616 OTC MONOGRAPH FINAL part341 Best Choice ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 63941-216_4e5b7d39-8263-48ab-a445-479497dbc7c3 63941-216 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090116 OTC MONOGRAPH FINAL part335 Best Choice BISMUTH SUBSALICYLATE 262 mg/15mL 63941-218_21670025-19f4-4855-9b29-cfde02029712 63941-218 HUMAN OTC DRUG Tussin DM Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20090326 OTC MONOGRAPH FINAL part341 Best Choice DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 63941-227_e9c0ff1f-7788-44ca-8880-40196904b1d2 63941-227 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET ORAL 20130308 OTC MONOGRAPH NOT FINAL part343 Best Choice (Valu Merchandisers Company) ASPIRIN 81 mg/1 63941-229_eb6cc940-a5a8-4fba-938e-c190b6d047fd 63941-229 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20120130 OTC MONOGRAPH NOT FINAL part348 Valu Merchandisers, Co. HYDROCORTISONE 10 mg/g 63941-230_8e96e588-8268-4ceb-b2f1-02d208cfedaf 63941-230 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20100726 OTC MONOGRAPH FINAL part341 Valu Merchandisers Company (Best Choice) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 63941-231_ffe2e60e-df78-4a7f-a644-d602f12cc6ba 63941-231 HUMAN OTC DRUG PAIN RELIEVER PM Extra Strength Acetaminophen, Diphenhydramine HCl CAPSULE, GELATIN COATED ORAL 20130308 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 63941-236_1a537768-b69b-4381-a0b7-07d1074161ff 63941-236 HUMAN OTC DRUG Nighttime sleep aid DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part338 Best Choice (Valu Merchandisers Company) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 63941-238_3a479705-3e95-4749-95fc-bd569a1b65a6 63941-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130730 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) DOCUSATE SODIUM 100 mg/1 63941-242_6460f7b6-d951-480a-80f6-d5dff69c14b7 63941-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20140331 OTC MONOGRAPH FINAL part347 Best Choice (Valu Merchandisers Company) DIMETHICONE 125 mg/1 63941-248_08d5b124-bf3d-4f62-b875-1433efef416f 63941-248 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol CREAM TOPICAL 20090112 OTC MONOGRAPH FINAL part341 Valu Merchandisers, co CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100g; kg/100g; kg/100g 63941-249_91603da8-ca70-428f-abd2-09c1ef0fdb62 63941-249 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19930804 OTC MONOGRAPH FINAL part343 VALUE MERCHANDISERS COMPANY, INC. ASPIRIN 325 mg/1 63941-250_2c8fad7d-f841-415f-ad93-210da1e76e90 63941-250 HUMAN OTC DRUG Antacid Antigas Maximum Strength ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE SUSPENSION ORAL 20090408 OTC MONOGRAPH FINAL part331 Best Choice ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 63941-251_a741fad1-5863-4a41-8a98-9d10f7778b23 63941-251 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 20140430 OTC MONOGRAPH FINAL part340 Best Choice (Valu Merchandisers Company) CAFFEINE 200 mg/1 63941-252_dd5bb740-02fb-46db-bda2-2127b9e6566a 63941-252 HUMAN OTC DRUG Stay Awake Maximum strength Caffeine TABLET ORAL 20100921 OTC MONOGRAPH FINAL part340 Valu Merchandisers Company (Best Choice) CAFFEINE 200 mg/1 63941-255_4b7a9e6e-aaad-491d-8db4-4eca5bc343af 63941-255 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20061009 ANDA ANDA074916 Valu Merchandisers Company IBUPROFEN 100 mg/5mL 63941-261_48cd0917-6dd8-44c8-9c98-cb5ba1360bff 63941-261 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20120523 ANDA ANDA074916 Valu Merchandisers Company IBUPROFEN 100 mg/5mL 63941-262_48cd0917-6dd8-44c8-9c98-cb5ba1360bff 63941-262 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20080116 ANDA ANDA074916 Valu Merchandisers Company IBUPROFEN 100 mg/5mL 63941-276_0202b560-527e-4682-9a8f-3ba92488a839 63941-276 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70 Percent Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20140930 OTC MONOGRAPH NOT FINAL part333A Best Choice (Valu Merchandisers Company) ISOPROPYL ALCOHOL 70 mL/100mL 63941-277_d7149638-2bd9-480f-858d-35b2580e3152 63941-277 HUMAN OTC DRUG Rubbing Alcohol 91 percent Isopropyl Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A Best Choice (Valu Merchandisers Company) ISOPROPYL ALCOHOL 91 mL/100mL 63941-278_72f26151-4f34-460d-9e05-106203a13184 63941-278 HUMAN OTC DRUG Milk of Magnesia Original MAGNESIUM HYDROXIDE SUSPENSION ORAL 20090402 OTC MONOGRAPH FINAL part334 Best Choice MAGNESIUM HYDROXIDE 1200 mg/15mL 63941-281_1f23c5d1-a188-4125-b9fb-0225c1e8a3a5 63941-281 HUMAN OTC DRUG Milk of Magnesia Mint MAGNESIUM HYDROXIDE SUSPENSION ORAL 20090708 OTC MONOGRAPH FINAL part334 Best Choice MAGNESIUM HYDROXIDE 1200 mg/15mL 63941-299_29676ff5-ca6d-471f-aab2-45e5a786eab6 63941-299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 20070731 OTC MONOGRAPH NOT FINAL part356 Valu Merchandisers.Co CETYLPYRIDINIUM CHLORIDE .07 kg/100L 63941-305_c66ef962-70d4-4bda-bca0-12b5d09238d0 63941-305 HUMAN OTC DRUG Best Choice Clotrimazole Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Valu Merchandisers Company CLOTRIMAZOLE 10 mg/g 63941-307_60e99556-af5f-498d-b0b7-967c46f9bace 63941-307 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090508 OTC MONOGRAPH FINAL part333 Best Choice ISOPROPYL ALCOHOL 70 mL/100mL 63941-311_93c250ac-fef8-4b86-b600-4501cd37a3db 63941-311 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090106 OTC MONOGRAPH FINAL part358H Valu Merchandisers Co PYRITHIONE ZINC 1 g/100mL 63941-312_75e297a7-5d39-4122-ab9f-5ac83c2fb795 63941-312 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20120229 OTC MONOGRAPH NOT FINAL part348 Valu Merchandisers, Co. HYDROCORTISONE 10 mg/g 63941-313_4d1ca805-3b46-4ec0-bcf2-aca6d4005c9f 63941-313 HUMAN OTC DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 20120130 OTC MONOGRAPH NOT FINAL part348 Valu Merchandisers, Co. HYDROCORTISONE 10 mg/g 63941-314_90c12c45-4c04-440f-9b35-729d1fc962b6 63941-314 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B OINTMENT TOPICAL 20120716 OTC MONOGRAPH FINAL part333B Valu Merchandisers, Co. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 63941-315_93d35e02-db63-4142-941f-573eda61e38e 63941-315 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20120905 OTC MONOGRAPH FINAL part333B Valu Merchandisers, Co. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 63941-316_a984aa9e-c483-470b-a80a-012ef5519536 63941-316 HUMAN OTC DRUG Allergic Itch Relief Diphenhydramine HCl, Zinc acetate CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part336 Valu Merchandisers, Co. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 63941-317_94a508ef-89e1-4cfe-8175-9d57c3788db1 63941-317 HUMAN OTC DRUG Muscle and Joint Pain Relief MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20120130 OTC MONOGRAPH NOT FINAL part348 Valu Merchandisers, Co. MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g 63941-318_46ff23e9-7824-4bee-a14c-0e2b0806d0ef 63941-318 HUMAN OTC DRUG Diaper Rash Zinc Oxide CREAM TOPICAL 20120130 OTC MONOGRAPH FINAL part347 Valu Merchandisers, Co. ZINC OXIDE 400 mg/g 63941-326_81deb270-7b7f-4939-9e01-c820ec941a8e 63941-326 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19991025 OTC MONOGRAPH NOT FINAL part356 Valu Merchandisers, Co., EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 63941-333_6cd4146e-0104-4118-8fd8-f15557a37a49 63941-333 HUMAN OTC DRUG Acetaminophen - APAP Arthritis Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Valu Merchandisers Company ACETAMINOPHEN 650 mg/1 63941-336_dc585b2e-10c2-4a31-8400-34cde7e11a43 63941-336 HUMAN OTC DRUG Acetaminophen - APAP 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Valu Merchandisers Company ACETAMINOPHEN 650 mg/1 63941-338_98d32d84-707f-4d1e-82fb-7bcff50386af 63941-338 HUMAN OTC DRUG Mucus Relief DM MAX Maximum Strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL 63941-341_9d8258c8-133c-458b-adba-7a209e26af0b 63941-341 HUMAN OTC DRUG Daytime Sinus Acetaminophen and Phenylephrine HCI CAPSULE, LIQUID FILLED ORAL 20120529 OTC MONOGRAPH FINAL part341 VALU MERCHANDISERS COMPANY ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 63941-351_c4f63f37-715b-462a-b5fb-a7bc58461de5 63941-351 HUMAN OTC DRUG ACID REDUCER Ranitidine Hydrochloride TABLET ORAL 20120330 ANDA ANDA200536 Valu Merchandisers Company RANITIDINE HYDROCHLORIDE 150 mg/1 63941-352_c369afdb-43ba-482b-a051-83c42c09a64a 63941-352 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20120710 ANDA ANDA201745 Valu Merchandisers Company RANITIDINE HYDROCHLORIDE 75 mg/1 63941-354_29fc9be7-be3c-4584-befe-7e71405ec6e8 63941-354 HUMAN OTC DRUG Tolnaftate Tolnaftate CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part333C Valu Merchandisers, Co. TOLNAFTATE 1 g/100g 63941-360_32201cc5-e4e1-4d93-b48e-727179d000d8 63941-360 HUMAN OTC DRUG NON ASPIRIN PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20120910 OTC MONOGRAPH FINAL part338 Valu Merchandisers Company (Best Choice) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 63941-370_59b8ac8e-024d-4925-a732-37daeaffb772 63941-370 HUMAN OTC DRUG Enteric Coated Aspirin regular strength Aspirin TABLET, COATED ORAL 20111111 OTC MONOGRAPH FINAL part343 Best Choice (Valu Merchandisers Company) ASPIRIN 325 mg/1 63941-373_cdf58879-3ce7-4219-a99f-53b57ab57401 63941-373 HUMAN OTC DRUG Headache Relief PM Acetaminophen and Diphenhydramine Citrate TABLET ORAL 20040607 OTC MONOGRAPH FINAL part338 VALUE MERCHANDISERS COMPANY, INC. ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 63941-376_573b2bb6-82b4-4830-84bc-c52bb0d548a8 63941-376 HUMAN OTC DRUG Sore Throat Relief Cherry Phenol SPRAY ORAL 20140829 OTC MONOGRAPH NOT FINAL part356 Best Choice (Valu Merchandisers Company) PHENOL 1.4 g/100mL 63941-378_60ad5e40-7945-45a3-9a89-b5a1e04f2323 63941-378 HUMAN OTC DRUG Childrens Day Time Cold and Cough Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20140731 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 63941-379_b0c6bd1d-f853-4ad7-ac23-9d1000084712 63941-379 HUMAN OTC DRUG Childrens Night Time Cold and Cough Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20140731 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 63941-390_985573ef-df04-4aae-981b-4b5cac7d1818 63941-390 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20140829 OTC MONOGRAPH FINAL part347 Best Choice (Valu Merchandisers Company) WITCH HAZEL 842 mg/mL 63941-397_14fb761d-c6b6-49ac-bb58-e7cb3a1c140f 63941-397 HUMAN OTC DRUG Chewable Aspirin Aspirin TABLET, CHEWABLE ORAL 20010904 OTC MONOGRAPH NOT FINAL part356 VALUE MERCHANDISERS COMPANY, INC. ASPIRIN 81 mg/1 63941-403_7cd56c6a-70cb-40ef-98b0-aa960a1a2a1d 63941-403 HUMAN OTC DRUG Hand wash Benzalkonium chloride LIQUID TOPICAL 20141009 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers, Co BENZALKONIUM CHLORIDE 1.3 mg/mL 63941-407_2904b24c-5b25-48a1-8bb3-9dcdaca2879c 63941-407 HUMAN OTC DRUG Best Choice Cold Sore Treatment Camphor CREAM TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part348 Best Choice BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g 63941-411_013c7989-4394-48e4-838d-b68ef077fc69 63941-411 HUMAN OTC DRUG Cold and Cough High Blood Pressure Chlorpheniramine maleate, Dextromethorphan HBr TABLET ORAL 20030503 OTC MONOGRAPH FINAL part341 VALUE MERCHANDISERS COMPANY, INC. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 63941-414_660bf472-1ce1-4c97-83aa-e04d1144ac54 63941-414 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090203 OTC MONOGRAPH NOT FINAL part356 Best Choice (Valu Merchandisers Company) HYDROGEN PEROXIDE 2.65 mL/100mL 63941-439_ccf4a486-5d12-452c-9fd7-ca78ddf6ff58 63941-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers,CO ALCOHOL 700 mg/mL 63941-440_8244057c-8522-4871-8576-a15b9583cbb7 63941-440 HUMAN OTC DRUG Aspirin Adult low strength Aspirin TABLET, DELAYED RELEASE ORAL 20100726 OTC MONOGRAPH FINAL part343 Valu Merchandisers Company (Best Choice) ASPIRIN 81 mg/1 63941-441_c7e09164-cdab-4aef-a813-2c02ede6a49d 63941-441 HUMAN OTC DRUG Safety Coated Aspirin Aspirin TABLET ORAL 20100821 OTC MONOGRAPH NOT FINAL part343 Valu Merchandisers Company (Best Choice) ASPIRIN 81 mg/1 63941-449_1ebb39d5-85e6-4c9c-b78d-46b11ddff1e1 63941-449 HUMAN OTC DRUG Junior Strength Pain Reliever Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 VALUE MERCHANDISERS COMPANY, INC. ACETAMINOPHEN 160 mg/1 63941-452_e74dd789-4de3-4afc-8e2f-3554ecfbeaf3 63941-452 HUMAN OTC DRUG Childrens Pain Relief Grape Flavor Acetaminophen TABLET, CHEWABLE ORAL 20041206 OTC MONOGRAPH NOT FINAL part343 VALUE MERCHANDISERS COMPANY, INC. ACETAMINOPHEN 80 mg/1 63941-470_052dcaa3-3ce7-4996-81f5-28df22865cb6 63941-470 HUMAN OTC DRUG Multi-Symptom Non-Aspirin Cold Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050715 OTC MONOGRAPH FINAL part341 VALUE MERCHANDISERS COMPANY, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 63941-473_2db80870-9121-40b0-80ae-eb5e29703931 63941-473 HUMAN OTC DRUG Multi-Symptom Cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050721 OTC MONOGRAPH FINAL part341 VALUE MERCHANDISERS COMPANY, INC. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 63941-519_7686b99e-cb60-4e49-b2a2-689b8e8d8eb5 63941-519 HUMAN OTC DRUG Extra Strength Non-Aspirin Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 VALUE MERCHANDISERS COMPANY, INC. ACETAMINOPHEN 500 mg/1 63941-520_85f54157-2661-46e8-8a83-9670dbe58d6d 63941-520 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100830 NDA NDA021855 Best Choice (Valu Merchandisers Company) LOPERAMIDE HYDROCHLORIDE 2 mg/1 63941-525_9ebb79a5-47ba-47ff-b1b0-fa5daf665786 63941-525 HUMAN OTC DRUG Hemorrhoidal Pad Witch Hazel Pad CLOTH TOPICAL 20111201 OTC MONOGRAPH FINAL part346 Valu Merchandisers, Co. WITCH HAZEL 5 g/1 63941-526_ee2fab3c-b65b-43a9-9da8-288bc2b0bf44 63941-526 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Valu Merchandisers Company LORATADINE 10 mg/1 63941-527_8df3ddbe-f143-41c5-b848-b1999c3dc2a8 63941-527 HUMAN OTC DRUG Severe Sinus Congestion and Pain Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, COATED ORAL 20050806 OTC MONOGRAPH NOT FINAL part343 VALUE MERCHANDISERS COMPANY, INC. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 63941-528_a070a784-fcd5-4af5-9b1d-1cc63153843a 63941-528 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Valu Merchandisers Company LORATADINE 10 mg/1 63941-530_e4f014f6-ca12-4a40-90ae-81b588d2b1d3 63941-530 HUMAN OTC DRUG Antigas Antiflatulent ultra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20100713 OTC MONOGRAPH FINAL part332 Best Choice (Valu Merchandisers Company) DIMETHICONE 180 mg/1 63941-550_2b7957c5-69d4-42e7-9f6f-b4e8d8ece5dc 63941-550 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100713 OTC MONOGRAPH FINAL part332 Valu Merchandisers Company (Best Choice) DIMETHICONE 125 mg/1 63941-556_42b7850d-6eb6-4b38-9da4-173a8f6a9436 63941-556 HUMAN OTC DRUG Extra Strength Pain Relief PM Acetaminophen and Diphenhydramine HCl CAPSULE ORAL 20071217 OTC MONOGRAPH FINAL part341 VALUE MERCHANDISERS COMPANY, INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 63941-602_943c21e0-8376-4d91-be86-aa627d4dca2d 63941-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part334 Valu Merchandisers, Co. MAGNESIUM SULFATE 1 g/g 63941-626_9d99b3a1-fc20-436f-94ef-a4edb81b14ab 63941-626 HUMAN OTC DRUG Best Choice absolute Daily Moisturizing Broad Spectrum SPF 15 Sunscreen Avobenzone, Homosalate, Octinoxate, Octocrylene CREAM TOPICAL 20121215 OTC MONOGRAPH NOT FINAL part352 Valu Merchandisers Company AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 20; 30; 50; 26 mg/mL; mg/mL; mg/mL; mg/mL 63941-630_922e6a78-c892-4413-8153-9dee78be16c8 63941-630 HUMAN OTC DRUG Travel Ease Dimenhydrinate TABLET ORAL 20100810 OTC MONOGRAPH FINAL part336 Best Choice (Valu Merchandisers Company) DIMENHYDRINATE 50 mg/1 63941-641_c02f1cf8-fabf-4af0-b580-8f01f01497f2 63941-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140502 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers, Co BENZALKONIUM CHLORIDE .999 mg/mL 63941-664_469e4567-43f6-45b7-b380-08fd90bce2f7 63941-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19980315 OTC MONOGRAPH NOT FINAL part356 Valu Merchandisers, Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 63941-670_638cf69a-ac98-465b-9f99-25438731e01e 63941-670 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine Hydrochloride TABLET ORAL 20100830 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 63941-690_8d5d69e3-de30-4692-8ba4-ae08cf0eb4bc 63941-690 HUMAN OTC DRUG Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20100827 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63941-693_385a2ea6-5c85-4230-b4a6-7b7db5529ceb 63941-693 HUMAN OTC DRUG Best Choice Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20120724 OTC MONOGRAPH FINAL part333B Valu Merchandisers, Co. BACITRACIN ZINC 500 [USP'U]/g 63941-775_93a0cf6a-70cc-4e14-9531-6038ccb2f905 63941-775 HUMAN OTC DRUG Best Choice Oil-Free Acne Wash Foaming Scrub Salicylic Acid LOTION TOPICAL 20121215 OTC MONOGRAPH FINAL part333D Valu Merchandisers Company SALICYLIC ACID 20 mg/mL 63941-804_d11f7c2f-6b1e-439a-aca5-1615de1e646c 63941-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers, CO ISOPROPYL ALCOHOL 91 mg/mL 63941-805_f3dd92e9-928f-4224-be65-7207eb7bdd0a 63941-805 HUMAN OTC DRUG Witch Hazel Witch Hazel OIL ORAL; TOPICAL 20090424 OTC MONOGRAPH FINAL part346 Best Choice WITCH HAZEL 86 mL/100mL 63941-810_1f645ca5-ba58-4c29-a0d6-cdc76ec07975 63941-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20031124 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers, CO. ISOPROPYL ALCOHOL 500 mg/mL 63941-835_f245bfc0-1ebf-4302-9f84-eac80c894b1f 63941-835 HUMAN OTC DRUG Best Choice Earwax Removal Kit Carbamide peroxide LIQUID TOPICAL 20141127 OTC MONOGRAPH FINAL part344 Valu Merchandisers, Co. CARBAMIDE PEROXIDE 65 mg/mL 63941-845_9a7126aa-9df3-4218-a84e-3b410556f087 63941-845 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20141024 OTC MONOGRAPH FINAL part344 Valu Merchandisers, Co ISOPROPYL ALCOHOL 613 mg/mL 63941-890_ec5b62a2-b9ae-425e-b1fc-8be1924f0256 63941-890 HUMAN OTC DRUG Sinus and Allergy PE maximum strength Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20100722 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 63941-939_5e0f3eec-fc33-40e0-9992-5310fc9452c3 63941-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Valu Merchandisers Company CETIRIZINE HYDROCHLORIDE 10 mg/1 63941-945_b0c4b716-d634-4101-be6e-d237c7382e3f 63941-945 HUMAN OTC DRUG Body Wash triclosan LIQUID TOPICAL 20090106 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers, Co TRICLOSAN 1.5 mg/mL 63941-949_ec9e844d-0b99-417f-9b41-acaaeab36fe8 63941-949 HUMAN OTC DRUG Cold and Hot Medicated Pain Relief Large Menthol PATCH TOPICAL 20110912 OTC MONOGRAPH NOT FINAL part348 Valu Merchandisers Company, Inc. MENTHOL 875 mg/1 63941-950_ff0871b2-0363-463a-bf7e-7399370fd32d 63941-950 HUMAN OTC DRUG Cold and Hot Medicated Pain Relief Small Menthol PATCH TOPICAL 20110912 OTC MONOGRAPH NOT FINAL part348 Valu Merchandisers Company, Inc. MENTHOL 400 mg/1 63941-951_4e7af651-5cac-4d9c-9a9e-1fd69a913441 63941-951 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120816 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers, CO ALCOHOL 578 mg/mL 63941-952_0e8e56bf-1da2-461b-9fbb-baa0f2cbcba5 63941-952 HUMAN OTC DRUG Dry Scalp Pyrithione zinc SHAMPOO TOPICAL 20090106 OTC MONOGRAPH FINAL part358H Valu Merchandisers Co. PYRITHIONE ZINC 1 g/100mL 63941-970_43e06f54-7f98-4c17-b975-aeda195de489 63941-970 HUMAN OTC DRUG Allergy Antihistamine Diphenhydramine HCl CAPSULE ORAL 20100810 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63956-001_9f210a1f-556a-4ad0-8427-4620a5fc33e1 63956-001 HUMAN OTC DRUG emmi dent Sodium Fluoride Anticavity Mild SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20140422 OTC MONOGRAPH FINAL part355 EMAG AG SODIUM FLUORIDE .16 g/100g 63961-003_c8a28ec1-13e6-4d0f-bcac-58b6747e2fdc 63961-003 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20110201 UNAPPROVED MEDICAL GAS Middlesex Gases and Technologies, Inc. AIR 1000 mL/L 63961-100_fd926da1-0890-4372-be50-8d260e71ad98 63961-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19970728 UNAPPROVED MEDICAL GAS Middlesex Gases and Technologies, Inc. OXYGEN 990 mL/L 63961-200_bd765ce2-86bf-4dc8-b314-34a09810914a 63961-200 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19970728 UNAPPROVED MEDICAL GAS Middlesex Gases and Technologies, Inc. NITROGEN 990 mL/L 63972-002_369ec9a7-1d45-4010-86b2-8098a2dad2b3 63972-002 HUMAN OTC DRUG CENTURY 21 LYMPHATIC DRAINAGE STRYCHNOS NUX-VOMICA SEED, BARIUM CHLORIDE DIHYDRATE, LACHESIS MUTA VENOM, CONIUM MACULATUM FLOWERING TOP, GOLDENSEAL, IODINE, SILICON DIOXIDE, PHOSPHORUS, QUININE SULFATE, SILYBUM MARIANUM SEED, CHELIDONIUM MAJUS, BERBERIS VULGARIS ROOT BARK, SONIA CANADENSIS ROOT, MERCURIUS SOLUBILIS, CEANOTHUS AMERICANUS LEAF, SOLIDAGO VIRGAUREA FLOWERING TOP, BOS TAURUS BILE, APIS MELLIFERA LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc APIS MELLIFERA; BARIUM CHLORIDE DIHYDRATE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS BILE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; IODINE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PHOSPHORUS; QUININE SULFATE; SILICON DIOXIDE; SILYBUM MARIANUM SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL 63972-003_61c2f388-041b-448a-b66a-b30f1364fce6 63972-003 HUMAN OTC DRUG CENTURY 21 ACUTE STRESS ARNICA MONTANA, ARSENIC TRIOXIDE, BELLIS PERENNIS, PASSIFLORA INCARNATA FLOWERING TOP, VALERIAN, APIS MELLIFERA, HUMAN BREAST TUMOR CELL, HELIANTHEMUM CANADENSE, CLEMATIS RECTA FLOWERING TOP, ARABICA COFFEE BEAN, STRYCHNOS IGNATII SEED, LACHESIS MUTA VENOM, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM CHLORIDE, SODIUM SULFATE, ORNITHOGALUM UMBELLATUM, PHOSPHORIC ACID, SALIX NIGRA BARK, DELPHINIUM STAPHISAGRIA SEED LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc APIS MELLIFERA; ARABICA COFFEE BEAN; ARNICA MONTANA; ARSENIC TRIOXIDE; BELLIS PERENNIS; CLEMATIS RECTA FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; HELIANTHEMUM CANADENSE; HUMAN BREAST TUMOR CELL; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORIC ACID; SALIX NIGRA BARK; SODIUM CHLORIDE; SODIUM SULFATE; STRYCHNOS IGNATII SEED; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL 63972-004_64baaa23-56a2-4689-bfa0-a2c44f4b23ff 63972-004 HUMAN OTC DRUG CENTURY 21 DETOX-VIRUS ARANEUS DIADEMATUS, RANCID BEEF, PHYTOLACCA AMERICANA ROOT, ECHINACEA ANGUSTIFOLIA, ASTRAGALUS PROPINQUUS ROOT, BAPTISIA TINCTORIA ROOT, GOLDENSEAL, LACHESIS MUTA VENOM, GELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, ARSENIC TRIOXIDE, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIG, BILBERRY, APIS MELLIFERA LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc APIS MELLIFERA; ARANEUS DIADEMATUS; ARSENIC TRIOXIDE; ASTRAGALUS PROPINQUUS ROOT; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BILBERRY; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; RANCID BEEF; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL 63972-005_f0cc7f75-8737-4e59-9948-caabb98a62f2 63972-005 HUMAN OTC DRUG CENTURY 21 CHRONIC STRESS AMERICAN GINSENG, GOLDENSEAL, CEANOTHUS AMERICANUS LEAF, ACTIVATED CHARCOAL, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SOLIDAGO VIRGAUREA FLOWERING TOP, CYCLAMEN PURPURASCENS TUBER, TARAXACUM OFFICINALE ROOT, ARSENIC TRIOXIDE, PHOSPHORUS, CALCIUM SULFIDE, TRIFOLIUM PRATENSE FLOWER, KEROSENE, FUCUS VESICULOSUS LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc ACTIVATED CHARCOAL; AMERICAN GINSENG; ARSENIC TRIOXIDE; CALCIUM SULFIDE; CEANOTHUS AMERICANUS LEAF; CYCLAMEN PURPURASCENS TUBER; FUCUS VESICULOSUS; GOLDENSEAL; KEROSENE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE ROOT; TRIFOLIUM PRATENSE FLOWER 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL 63972-006_cf397737-b571-432a-9763-3127a98f1276 63972-006 HUMAN OTC DRUG CENTURY 21 ENVIROMENTAL DETOX CORTICOTROPIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MAGNESIUM SULFATE HEPTAHYDRATE, POTASSIUM PHOSPHATE, DIBASIC, NITRIC ACID, BENZOIC ACID, SILICON DIOXIDE, ARSENIC TRIOXIDE, MERCURIUS SOLUBILIS, PHOSPHORUS, ACTIVATED CHARCOAL, STRYCHNOS NUX-VOMICA SEED, ALUMINUM, PHYTOLACCA AMERICANA ROOT, BAPTISIA TINCTORIA ROOT, SILVER NITRATE, SPIGELIA ANTHELMIA, APIS MELLIFERA LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc ACTIVATED CHARCOAL; ALUMINUM; APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BENZOIC ACID; CORTICOTROPIN; MAGNESIUM SULFATE HEPTAHYDRATE; MERCURIUS SOLUBILIS; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM PHOSPHATE, DIBASIC; SILICON DIOXIDE; SILVER NITRATE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL 63972-007_c73f0f05-dfb8-4134-baf7-f08eaad29942 63972-007 HUMAN OTC DRUG CENTURY 21 HEAVY METAL DETOX GARLIC, GOLD, ATROPA BELLADONNA, BERBERIS VULGARIS ROOT BARK, CAUSTICUM, CONIUM MACULATUM FLOWERING TOP, CALCIUM SULFIDE, HYPERICUM PERFORATUM, IPECAC, ALUMINUM, SILVER, ARSENIC, BARIUM CARBONATE, BERYLLIUM, BORON, BROMINE, CADMIUM, D and C BLACK NO. 2, CERIUM, CESIUM, CHROMIUM, COBALT, COPPER, DYSPROSIUM, ERBIUM, EUROPIUM, IRON, FLUORINE, GADOLINIUM, GALLIUM, GERMANIUM, HOLMIUM, HYDROGEN, INDIUM, IODINE, LANTHANUM, LITHIUM CARBONATE, MANGANESE, MERCURIUS SOLUBILIS, MOLYBDENUM, NEODYMIUM, NICKEL LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc ALUMINUM; APIS MELLIFERA; ARSENIC; ATROPA BELLADONNA; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BERYLLIUM; BORON; BROMINE; CADMIUM; CALCIUM SULFIDE; CAUSTICUM; CERIUM; CESIUM; CHROMIUM; COBALT; CONIUM MACULATUM FLOWERING TOP; COPPER; D&C BLACK NO. 2; DYSPROSIUM; ERBIUM; EUROPIUM; FLUORINE; GADOLINIUM; GALLIUM; GARLIC; GERMANIUM; GOLD; HOLMIUM; HYDROGEN; HYPERICUM PERFORATUM; INDIUM; IODINE; IPECAC; IRON; LANTHANUM; LEAD; LITHIUM CARBONATE; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM; NICKEL; NIOBIUM; NITROUS OXIDE; OXYGEN; PRASEODYMIUM; RUBIDIUM; SAMARIUM; SCANDIUM; SELENIUM; SILICON DIOXIDE; SILVER; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THULIUM; TIN; TITANIUM; VANADIUM; VERATRUM ALBUM ROOT; YTTERBIUM; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL 63972-008_0dcd995f-444a-4daf-9f96-fde8b3d6ce6b 63972-008 HUMAN OTC DRUG CENTURY 21 FUNGAL YEAST INFECTION CANDIDA ALBICANS, SEPIA OFFICINALIS JUICE, ECHINACEA, UNSPECIFIED, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, THUJA OCCIDENTALIS LEAFY TWIG, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ASTRAGALUS PROPINQUUS ROOT, MERCURIUS SOLUBILIS, GOLDENSEAL, PHYTOLACCA AMERICANA ROOT, BERBERIS VULGARIS ROOT BARK, GENTIANA LUTEA ROOT, APIS MELLIFERA LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc APIS MELLIFERA; ASTRAGALUS PROPINQUUS ROOT; BERBERIS VULGARIS ROOT BARK; CANDIDA ALBICANS; ECHINACEA, UNSPECIFIED; GENTIANA LUTEA ROOT; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL 63972-009_acd58147-7ff9-4115-91f8-581c31f124c6 63972-009 HUMAN OTC DRUG CENTURY 21 BACTERIAL DETOX ECHINACEA ANGUSTIFOLIA, BAPTISIA TINCTORIA ROOT, PHYTOLACCA AMERICANA ROOT, FERROSOFERRIC PHOSPHATE, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA RECUTITA, MERCURIUS SOLUBILIS, GELSEMIUM SEMPERVIRENS ROOT, LACHESIS MUTA VENOM, SOLANUM DULCAMARA TOP, RANCID BEEF, GARLIC, APIS MELLIFERA LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; GARLIC; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; RANCID BEEF; SOLANUM DULCAMARA TOP 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL 63972-010_d73a2dde-72de-4cca-801d-84a40ed5fbee 63972-010 HUMAN OTC DRUG CENTURY 21 PARASITE DETOX BARIUM CARBONATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SILYBUM MARIANUM SEED, CHELIDONIUM MAJUS, ARTEMISIA MARITIMA FLOWER, FERRIC CHLORIDE HEXAHYDRATE, SODIUM CHLORIDE, SCHOENOCAULON OFFICINALE SEED, SILICON DIOXIDE, SPIGELIA ANTHELMIA, SULFUR, THYROID, UNSPECIFIED, APIS MELLIFERA, TURPENTINE OIL, TEUCRIUM MARUM LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc APIS MELLIFERA; ARTEMISIA MARITIMA FLOWER; BARIUM CARBONATE; CHELIDONIUM MAJUS; FERRIC CHLORIDE HEXAHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SILYBUM MARIANUM SEED; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; SULFUR; TEUCRIUM MARUM; THYROID, UNSPECIFIED; TURPENTINE OIL 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 5 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL 63981-013_8daa92d5-55f0-450c-a151-84e188c0df06 63981-013 HUMAN OTC DRUG Kirkland Signature AllerClear D 12 hr Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20130110 ANDA ANDA076050 Costco Wholesale Company LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 63981-029_bb9e2f33-d60a-4eb2-996a-7c502e0f3f31 63981-029 HUMAN OTC DRUG kirkland signature quit 2 Nicotine Polacrilex GUM, CHEWING ORAL 20120515 ANDA ANDA076775 Costco Wholesale Company NICOTINE 2 mg/1 63981-100_fd33a681-2109-436e-bd9a-42f096bae3e9 63981-100 HUMAN OTC DRUG KIRKLAND SIGNATURE PRO-COMPLETE plus WHITENING sodium fluoride PASTE ORAL 20100913 OTC MONOGRAPH FINAL part355 Costco Wholesale Corporation SODIUM FLUORIDE 1.1 mg/g 63981-110_4fd05ca4-8dc0-4d01-831e-ac7386f829fb 63981-110 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130730 OTC MONOGRAPH NOT FINAL part334 Costco Wholesale DOCUSATE SODIUM 100 mg/1 63981-111_fc4ad05c-3d62-4450-8fad-95f1d4ffdc29 63981-111 HUMAN OTC DRUG Mens Kirkland Extra Strength Minoxidil SOLUTION TOPICAL 20100716 NDA NDA020834 Costco Wholesale Corporation MINOXIDIL 50 mg/mL 63981-117_5603d4c1-01f5-413b-a76d-8477098c411e 63981-117 HUMAN OTC DRUG Kirkland Signature Lansoprazole Delayed Release Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20131217 ANDA ANDA202319 Costco Wholesale Company LANSOPRAZOLE 15 mg/1 63981-130_72fc964a-bf30-4496-988a-1e7c702d27e5 63981-130 HUMAN OTC DRUG kirkland signature pain relief Acetaminophen SUSPENSION ORAL 19980930 OTC MONOGRAPH NOT FINAL part343 Costco Wholesale Company ACETAMINOPHEN 160 mg/5mL 63981-159_a4b5b451-bafa-4622-bba5-f968a968cc6e 63981-159 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 COSTCO WHOLESALE CORPORATION ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 63981-165_43c32c5f-d1eb-4e61-b97c-34ba640a7aed 63981-165 HUMAN OTC DRUG kirkland signature allerclear d 24hr Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20070521 ANDA ANDA075706 Costco Wholesale Company LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 63981-170_fb80942a-7af6-4d06-a797-9f3d0a5b91cb 63981-170 HUMAN OTC DRUG kirkland signature quit 4 Nicotine Polacrilex GUM, CHEWING ORAL 20120507 ANDA ANDA076789 Costco Wholesale Company NICOTINE 4 mg/1 63981-176_e98dc0ec-49a1-428c-8c1a-46540294993f 63981-176 HUMAN OTC DRUG Kirkland Signature Aller Tec D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080421 ANDA ANDA077170 Costco Wholesale Company CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 63981-194_d5d96078-ba87-4593-b15b-b7a646a8ab10 63981-194 HUMAN OTC DRUG kirkland signature acid controller Famotidine TABLET ORAL 20070524 ANDA ANDA077351 Costco Wholesale Company FAMOTIDINE 20 mg/1 63981-199_305e9514-844d-4621-9cdf-48041c105a16 63981-199 HUMAN OTC DRUG Ibuprofen IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20100708 ANDA ANDA078682 Costco Wholesale IBUPROFEN 200 mg/1 63981-224_bae0264d-a8cf-4519-832c-d825a0c17463 63981-224 HUMAN OTC DRUG kirkland signature anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030226 ANDA ANDA075232 Costco Wholesale Company LOPERAMIDE HYDROCHLORIDE 2 mg/1 63981-227_b5813da0-ebc1-400e-bcc1-ed4298a9a04f 63981-227 HUMAN OTC DRUG Enteric Aspirin Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH NOT FINAL part343 COSTCO WHOLESALE CORPORATION ASPIRIN 325 mg/1 63981-235_d1823161-df60-41b7-8bd6-c4c8c40ece5c 63981-235 HUMAN OTC DRUG Extra Strength Non-Aspirin PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 COSTCO WHOLESALE CORPORATION ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 63981-289_11af9116-e025-4ff2-8466-0e942b3728c0 63981-289 HUMAN OTC DRUG Kirkland Signature infants pain relief Acetaminophen SUSPENSION/ DROPS ORAL 19980311 OTC MONOGRAPH NOT FINAL part343 Costco Wholesale Company ACETAMINOPHEN 80 mg/.8mL 63981-291_a59f707f-5d6a-4ea5-aac6-13bc5c7bda35 63981-291 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 COSTCO WHOLESALE CORPORATION IBUPROFEN 200 mg/1 63981-294_3ec83b7a-4cad-4089-9306-c56e6d76078c 63981-294 HUMAN OTC DRUG kirkland signature Minoxidil Minoxidil AEROSOL, FOAM TOPICAL 20120417 ANDA ANDA091344 Costco Wholesale Company MINOXIDIL 5 g/100g 63981-306_be559dfe-9206-4df2-9ebd-218138c4d484 63981-306 HUMAN OTC DRUG kirkland signature laxaclear original prescription strength Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091107 ANDA ANDA090685 Costco Wholesale Company POLYETHYLENE GLYCOL 3350 17 g/17g 63981-329_9dff0cc6-1151-4b31-8906-fd9867be4485 63981-329 HUMAN OTC DRUG Allergy Medicine Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 COSTCO WHOLESALE CORPORATION DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 63981-344_cb462e10-124e-4ea3-9261-8c1fc7a9e1a6 63981-344 HUMAN OTC DRUG kirkland signature quit 2 Nicotine Polacrilex LOZENGE ORAL 20140912 ANDA ANDA077007 Costco Wholesale Company NICOTINE 2 mg/1 63981-368_afc43803-bb68-4bbc-b5df-ceed50cbf2e5 63981-368 HUMAN OTC DRUG kirkland signature naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20070604 ANDA ANDA074661 Costco Wholesale Company NAPROXEN SODIUM 220 mg/1 63981-380_69b4602f-05cc-41d8-9dad-3ec434001328 63981-380 HUMAN OTC DRUG Kirkland Signature Minoxidil Minoxidil SOLUTION TOPICAL 20130825 ANDA ANDA075598 Costco Wholesale Company MINOXIDIL 5 g/100mL 63981-386_29dd7453-c19b-4d07-a3d2-acd2b620625f 63981-386 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 COSTCO WHOLESALE CORPORATION DOXYLAMINE SUCCINATE 25 mg/1 63981-393_6c3fb205-3646-4e64-9964-425c9122d5d3 63981-393 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990302 ANDA ANDA075139 COSTCO WHOLESALE CORPORATION IBUPROFEN 200 mg/1 63981-441_5e3e3085-1e73-4a4c-8417-1c2d0cde8be4 63981-441 HUMAN OTC DRUG Kirkland Signature Sleep Aid Doxylamine succinate TABLET ORAL 20030627 ANDA ANDA040167 Costco Wholesale Company DOXYLAMINE SUCCINATE 25 mg/1 63981-453_99fda970-386d-4147-b601-4bcf21a63b06 63981-453 HUMAN OTC DRUG Suphedrine PE Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 COSTCO WHOLESALE CORPORATION PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 63981-458_e7ed7e4c-5a7b-4007-8ddb-40fb052e6e9c 63981-458 HUMAN OTC DRUG kirkland signature aller tec allergy Cetirizine Hydrochloride TABLET ORAL 20080325 ANDA ANDA078336 Costco Wholesale Company CETIRIZINE HYDROCHLORIDE 10 mg/1 63981-478_a3c96e1e-4013-4ed0-a2d4-569a1ae480e3 63981-478 HUMAN OTC DRUG Kirkland Signature Antacid calcium carbonate TABLET, CHEWABLE ORAL 20070615 OTC MONOGRAPH FINAL part331 Costco Wholesale Company CALCIUM CARBONATE 500 mg/1 63981-484_5ba0911f-d780-4bd7-a487-a6a3c8d2ab1c 63981-484 HUMAN OTC DRUG Kirkland Signature Non Aspirin Extra Strength Acetaminophen TABLET ORAL 20090603 OTC MONOGRAPH NOT FINAL part343 Costco Wholesale Company ACETAMINOPHEN 500 mg/1 63981-517_807a482d-ad15-410c-9f81-63f25c7647cb 63981-517 HUMAN OTC DRUG kirkland signature ibuprofen ib Ibuprofen TABLET, FILM COATED ORAL 20070622 ANDA ANDA077349 Costco Wholesale Company IBUPROFEN 200 mg/1 63981-519_cb3b66df-e385-43e7-a3ba-a6fbce319cdb 63981-519 HUMAN OTC DRUG RAPID RELEASE ACETAMINOPHEN Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 COSTCO WHOLESALE CORPORATION ACETAMINOPHEN 500 mg/1 63981-532_35d6d66f-f541-4e8d-9520-7b70077943f8 63981-532 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, FILM COATED ORAL 20051222 OTC MONOGRAPH FINAL part341 COSTCO WHOLESALE CORPORATION GUAIFENESIN 400 mg/1 63981-544_c21f0f3f-fb2c-43d1-80d0-3a80a157c792 63981-544 HUMAN OTC DRUG Kirkland Signature Arthritis Pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130118 ANDA ANDA075077 Costco Wholesale Company ACETAMINOPHEN 650 mg/1 63981-556_dbef9cb6-fe0e-475e-8fac-18cc52111bbd 63981-556 HUMAN OTC DRUG Extra Strength Rapid Release Acetaminophen PM Acetaminophen and Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 COSTCO WHOLESALE CORPORATION ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 63981-560_ed6780ea-3937-22e7-63d7-1c1567e9841b 63981-560 HUMAN OTC DRUG Multi-Symptom Daytime Cold Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20080329 OTC MONOGRAPH NOT FINAL part343 COSTCO WHOLESALE CORPORATION ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 63981-563_1a94c5b0-198c-c70b-9c69-c5d168e32a82 63981-563 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET, COATED ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 COSTCO WHOLESALE CORPORATION ASPIRIN 81 mg/1 63981-571_a011a0f4-d103-4d81-9665-7f271f565d12 63981-571 HUMAN OTC DRUG kirkland signature aller fex fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110423 ANDA ANDA076447 Costco Wholesale Company FEXOFENADINE HYDROCHLORIDE 180 mg/1 63981-591_fc1f2fa5-a67a-ec2d-2226-94e8519fae83 63981-591 HUMAN OTC DRUG Nighttime Cold Multi Symptom Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20100625 OTC MONOGRAPH NOT FINAL part343 COSTCO WHOLESALE CORPORATION ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 63981-604_abc087c7-8df9-44fb-a865-16d0eb6c8689 63981-604 HUMAN OTC DRUG kirkland signature ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20030625 ANDA ANDA072096 Costco Wholesale Company IBUPROFEN 200 mg/1 63981-612_2074d52e-8c0a-4e69-bfb1-864ffc07e25f 63981-612 HUMAN OTC DRUG kirkland signature allerclear Loratadine TABLET ORAL 20070522 ANDA ANDA076301 Costco Wholesale Company LORATADINE 10 mg/1 63981-700_c418c3ac-db38-42e9-adca-86454ca1ab43 63981-700 HUMAN OTC DRUG kirkland signature acetaminophen adult extra strength Acetaminophen TABLET ORAL 20090603 OTC MONOGRAPH NOT FINAL part343 Costco Wholesale Company ACETAMINOPHEN 500 mg/1 63981-701_e591b058-0856-4178-a225-3782745d2d13 63981-701 HUMAN OTC DRUG Multi-Symptom Cold Relief Acetaminophen, Chlorpehniramine HCl, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 COSTCO WHOLESALE CORPORATION 63981-766_786b0e7d-e43a-4509-a2ff-e49820ae9513 63981-766 HUMAN OTC DRUG kirkland signature pain and fever Acetaminophen LIQUID ORAL 20111219 OTC MONOGRAPH NOT FINAL part343 Costco Wholesale Company ACETAMINOPHEN 160 mg/5mL 63981-798_b790cd4a-22a6-41bc-85b9-34ce774ed3a9 63981-798 HUMAN OTC DRUG kirkland signature minoxidil Minoxidil SOLUTION TOPICAL 20120522 ANDA ANDA075598 Costco Wholesale Company MINOXIDIL 3 g/60mL 63981-852_6a8794e2-041a-482c-9db7-c48a9a6a8361 63981-852 HUMAN OTC DRUG Kirkland Signature Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20130424 ANDA ANDA091429 Costco Wholesale Company RANITIDINE HYDROCHLORIDE 150 mg/1 63981-873_cd1c3493-242c-4981-8561-ebbea938628f 63981-873 HUMAN OTC DRUG kirkland signature quit 4 Nicotine Polacrilex LOZENGE ORAL 20140912 ANDA ANDA077007 Costco Wholesale Company NICOTINE 4 mg/1 63981-903_d1072069-f843-4c97-815f-9d4aa1d3aef3 63981-903 HUMAN OTC DRUG kirkland signature cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20101202 OTC MONOGRAPH FINAL part341 Costco Wholesale Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL 63981-915_4792ee87-eda0-4b73-a2f9-27c88397412a 63981-915 HUMAN OTC DRUG kirkland signature omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080227 NDA NDA022032 Costco Wholesale Company OMEPRAZOLE 20 mg/1 63981-973_b910956a-52ff-4c0c-aef7-3196d847d607 63981-973 HUMAN OTC DRUG kirkland signature hydrocortisone plus maximum strength hydrocortisone CREAM TOPICAL 20091002 OTC MONOGRAPH NOT FINAL part348 Costco Wholesale Company HYDROCORTISONE 1 g/100g 63981-974_b306e1ef-6bea-4444-b9d0-34beb62a98db 63981-974 HUMAN OTC DRUG Kirklands Childrens Aller Tec cetirizine LIQUID ORAL 20090814 ANDA ANDA090254 Costco Wholesale Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 63983-0001_a3b88bfd-3a79-4478-8c1b-cf3f937f30cd 63983-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980213 UNAPPROVED MEDICAL GAS Community Medical Equipment OXYGEN 99 L/100L 63998-515_1c12dde5-9db7-4f27-b0e9-f4869a24b5c3 63998-515 HUMAN OTC DRUG United Laboratories 464 PUMP and PROTECT Alcohol Hand Sanitizer alcohol GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 United Laboratories Inc. ALCOHOL 600 mL/1000mL 63998-575_3d005536-a9d3-423a-a365-c0ac895371c7 63998-575 HUMAN OTC DRUG MicroMousse II Alcohol Free Hand Sanitizing Foam BENZETHONIUM CHLORIDE LIQUID TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part333 United Laboratories, Inc. BENZETHONIUM CHLORIDE 2 mg/mL 64009-056_a9274243-02b2-4e86-abb1-924f52c19ded 64009-056 HUMAN OTC DRUG Clean Xpress Alcohol Gel Instant Skin Sanitizer Clean Xpress Alcohol Gel Instant Skin Santizer LIQUID TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part333A Spartan Chemical Company, Inc. ALCOHOL 65.2 mL/100mL 64009-305_9288eba5-387f-4247-8a53-52f8e1f31c6c 64009-305 HUMAN OTC DRUG Spartan E2 Hand Wash and Sanitizer Benzalkonium Chloride SOAP TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333E Spartan Chemical Company, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL 64009-331_dac33ded-37a3-4214-bd52-d57c50fbd25a 64009-331 HUMAN OTC DRUG Lite nFoamy Lemon Blossom Hand Sanitizer Benzalkonium Chloride SOAP TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part333A Spartan Chemical Company BENZALKONIUM CHLORIDE 1 g/L 64009-332_bb5f0c4a-b064-4769-b3fa-526184192710 64009-332 HUMAN OTC DRUG Lite nFoamy Eucalyptus Mint Sanitizing Handwash Benzalkonium Chloride SOAP TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part333A Spartan Chemical Company BENZALKONIUM CHLORIDE 1.3 g/L 64009-333_f77d4826-62b0-4f10-b46e-5dd9d7cff0c7 64009-333 HUMAN OTC DRUG Lite nFoamy E2 Sanitizing Handwash Benzalkonium Chloride SOAP TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Spartan Chemical Company BENZALKONIUM CHLORIDE 1.3 g/L 64009-334_e54a464e-204a-40df-884e-634ca7051911 64009-334 HUMAN OTC DRUG Lite nFoamy E3 Hand Sanitizer Benzalkonium Chloride SOAP TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Spartan Chemical Company BENZALKONIUM CHLORIDE 1 g/L 64009-360_c3c154cb-4fe2-47ee-91f4-9b74b1266d16 64009-360 HUMAN OTC DRUG Spartan Antiseptic Hand Cleaner Chloroxylenol SOAP TOPICAL 20131018 OTC MONOGRAPH NOT FINAL part333E Spartan Chemical Company, Inc. CHLOROXYLENOL 10.1 mg/mL 64009-510_81675c35-5aad-414a-beaa-0dd17d7f8b87 64009-510 HUMAN OTC DRUG SPARTAN E2 HAND WASH AND SANITIZER Chloroxylenol LIQUID TOPICAL 20040922 20150930 OTC MONOGRAPH NOT FINAL part333E Spartan Chemical Company CHLOROXYLENOL 15.75 g/1000mL 64009-511_1a8b1665-b1a3-4e19-acfc-bf5c749f9283 64009-511 HUMAN OTC DRUG SPARTAN LITE N FOAMY E2 HAND WASH AND SANITIZER Chloroxylenol LIQUID TOPICAL 20061013 20150531 OTC MONOGRAPH NOT FINAL part333E Spartan Chemical Company CHLOROXYLENOL 15.75 g/1000mL 64011-009_cc23b098-1c7c-4c96-a18b-39a80b9b68e1 64011-009 HUMAN PRESCRIPTION DRUG Micro-K 10 Extencaps Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20090801 NDA NDA018238 Ther-Rx Corporation POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 64011-010_cc23b098-1c7c-4c96-a18b-39a80b9b68e1 64011-010 HUMAN PRESCRIPTION DRUG Micro-K Extencaps Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20090801 NDA NDA018238 Ther-Rx Corporation POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 64011-124_a96a8d64-4abd-4ef0-a2db-558d973c4029 64011-124 HUMAN PRESCRIPTION DRUG Clindesse clindamycin phosphate CREAM VAGINAL 20091101 NDA NDA050793 Ther-Rx Corporation CLINDAMYCIN PHOSPHATE 20 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 64011-215_9218e484-cb59-4bdc-a910-aeea2170646f 64011-215 HUMAN PRESCRIPTION DRUG Evamist estradiol SPRAY, METERED TRANSDERMAL 20090708 NDA NDA022014 Ther-Rx Corporation ESTRADIOL 1.53 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 64011-243_abdd05eb-69bf-4558-b678-7e8ac2684fb5 64011-243 HUMAN PRESCRIPTION DRUG Makena Hydroxyprogesterone Caproate INJECTION INTRAMUSCULAR 20110203 NDA NDA021945 Lumara Health Inc. HYDROXYPROGESTERONE CAPROATE 250 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 64011-246_7f439101-4f07-4602-83e7-5cb571e366dc 64011-246 HUMAN PRESCRIPTION DRUG gynazole 1 Butoconazole Nitrate CREAM VAGINAL 20121227 ANDA ANDA200923 Ther-Rx Corporation BUTOCONAZOLE NITRATE 100 mg/5g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 64024-100_7fdb7736-61c7-420f-a790-0a4af934f7f2 64024-100 HUMAN OTC DRUG Source Antibacterial Foaming Hand Original Triclosan LIQUID TOPICAL 20130104 OTC MONOGRAPH NOT FINAL part333A Aldi Inc. TRICLOSAN .46 mg/mL 64024-175_4dca678a-68cc-4bf2-9bf4-84b9fe77e98b 64024-175 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen TABLET ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 ALDI INC. ACETAMINOPHEN 500 mg/1 64024-190_3635475f-c628-4061-80a1-3289e53d2123 64024-190 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part336 ALDI INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 64024-484_a6d788ad-af43-4b3a-ac68-5646cd5096a7 64024-484 HUMAN OTC DRUG welby health acetaminophen Acetaminophen TABLET ORAL 19910812 OTC MONOGRAPH NOT FINAL part343 Aldi, Inc ACETAMINOPHEN 500 mg/1 64024-489_7b64c82f-fb4d-4511-894a-db4263405c49 64024-489 HUMAN OTC DRUG welby health antacid Calcium carbonate TABLET, CHEWABLE ORAL 20021023 OTC MONOGRAPH FINAL part331 Aldi, Inc CALCIUM CARBONATE 750 mg/1 64024-604_6b2bba5a-2db7-488d-a773-f0fc72b05f47 64024-604 HUMAN OTC DRUG welby health ibuprofen Ibuprofen TABLET ORAL 19930601 ANDA ANDA072096 Aldi, Inc IBUPROFEN 200 mg/1 64024-612_f3c586bc-c185-4037-b2c4-7b7db1ddaf55 64024-612 HUMAN OTC DRUG Welby health allergy relief Loratadine TABLET ORAL 20070412 ANDA ANDA076301 Aldi, Inc LORATADINE 10 mg/1 64024-685_e58a0d1d-4ede-499a-9b3f-e51b61498b8e 64024-685 HUMAN OTC DRUG welby health ibuprofen Ibuprofen LIQUID ORAL 20091209 ANDA ANDA074937 Aldi, Inc IBUPROFEN 100 mg/5mL 64024-962_7617df66-e042-48fe-bebe-76e85683e223 64024-962 HUMAN OTC DRUG Foaming Hand Wash Triclosan 0.46% LIQUID TOPICAL 20140213 OTC MONOGRAPH NOT FINAL part333A Aldi, Inc TRICLOSAN .46 mg/mL 64024-968_5be1ef4b-7832-4b46-a136-964e87b08f3c 64024-968 HUMAN OTC DRUG LACURA FOR MEN EXTREME BLAST Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20101108 OTC MONOGRAPH FINAL part350 ALDI INC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 200 mg/g 64024-969_90a5a5db-3572-4977-bf81-b29e35f7a05b 64024-969 HUMAN OTC DRUG LACURA BODY CARE SHOWER FRESH Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20101108 OTC MONOGRAPH FINAL part350 ALDI INC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 200 mg/g 64024-970_602de6c7-b1d8-4a5a-beac-d5083a8ab04d 64024-970 HUMAN OTC DRUG LACURA BODY CARE POWDER FRESH Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20101108 OTC MONOGRAPH FINAL part350 ALDI INC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 200 mg/g 64038-059_67469a82-09e3-4671-9776-f72ee54004bf 64038-059 HUMAN PRESCRIPTION DRUG Tramapap Tramadol Hydrochloride, Acetaminophen KIT 20100407 UNAPPROVED DRUG OTHER Living Well Pharmacy, Inc. 64038-313_50685541-a4de-4c8a-b0d4-ec14ce0b69da 64038-313 HUMAN PRESCRIPTION DRUG Cyclo/Mag CYCLOBENZAPRINE HYDROCHLORIDE, MAGNESIUM OXIDE KIT 20100309 UNAPPROVED DRUG OTHER Living Well Pharmacy, Inc. 64038-630_38c7d64b-ee76-4d72-b3d0-6d05eb5aa2a3 64038-630 HUMAN PRESCRIPTION DRUG Cyclo/Mag 10mg/200mg CYCLOBENZAPRINE HYDROCHLORIDE, MAGNESIUM OXIDE KIT 20100217 UNAPPROVED DRUG OTHER Living Well Pharmacy, Inc. 64038-944_8f97fcd2-08db-4b14-95c6-898c22188a2f 64038-944 HUMAN OTC DRUG XOTEN-C Methyl salicylate, Menthol, Capsaicin LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part348 Living Well Pharmacy Inc. CAPSAICIN; MENTHOL; METHYL SALICYLATE .002; 10; 20 g/100g; g/100g; g/100g 64048-2171_225f269f-3296-41f0-beb9-70cc72103dbf 64048-2171 HUMAN OTC DRUG Patch Scherer Labs Menthol PATCH TOPICAL 20141023 OTC MONOGRAPH NOT FINAL part348 Product Quest Mfg MENTHOL 5 g/1001 64048-2175_aabf3558-6156-4bd6-aad1-0b44148a8def 64048-2175 HUMAN OTC DRUG Acne Spot Treatment Benzoyl Peroxide 10% CREAM TOPICAL 20141031 OTC MONOGRAPH FINAL part333D Product Quest Mfg, LLC BENZOYL PEROXIDE 10 g/100g 64048-2176_85672b4b-bdcc-463b-80ff-4a5618b3634d 64048-2176 HUMAN OTC DRUG Itch Relief Clear Skin Protectant CVS Pramoxine HCl, Zinc Acetate SPRAY TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part348 Product Quest Mfg, LLC PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 1; .1 g/100g; g/100g 64048-2184_a0fa8909-0489-4691-99d3-1db851b5608d 64048-2184 HUMAN OTC DRUG 15 Tanning CVS Broad Spectrum SPF 15 LOTION TOPICAL 20141106 OTC MONOGRAPH NOT FINAL part352 Product Quest Mff, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL 64048-2205_0d987970-99bd-4dba-a02e-e968a2510e71 64048-2205 HUMAN OTC DRUG Cold and Hot CVS Menthol 7.6% Mehyl Salicylate 29.0% SPRAY TOPICAL 20141113 OTC MONOGRAPH NOT FINAL part348 Product Quest Mfg, LLC MENTHOL; METHYL SALICYLATE 7.6; 29 g/100g; g/100g 64048-3102_5804c90a-f368-4cde-abaf-47b77809855c 64048-3102 HUMAN OTC DRUG Dry Skin Treatment Studio 35 PETROLATUM 41% OINTMENT TOPICAL 20130215 OTC MONOGRAPH FINAL part347 Product Quest Mfg, LLC PETROLATUM 41 g/100g 64058-113_d938988c-0db3-4863-82c8-61bf06606fac 64058-113 HUMAN OTC DRUG Moisturizing Glucosamine Brand Capsaicin GEL TOPICAL 20100616 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories CAPSAICIN .02125 g/85g 64058-114_24e7c851-1cbd-487d-9788-7bfc1977f4d3 64058-114 HUMAN OTC DRUG Emu Essentials Brand Pain Relieving Capsaicin CREAM TOPICAL 20100202 OTC MONOGRAPH FINAL part348 Concept Laboratories, Inc. CAPSAICIN .02125 g/85g 64058-117_02b9d56a-ce1b-460b-8bd1-8e518a3a5484 64058-117 HUMAN OTC DRUG Painazin CP Capsaicin SPRAY TOPICAL 20110127 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .00025 g/mL 64058-118_4e46efaf-2928-410f-bf14-31517a6cea19 64058-118 HUMAN OTC DRUG Pure Relief Penetrating Pain Relief Capsaicin GEL TOPICAL 20131206 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .0295 g/118mL 64058-123_1939e655-93b2-4783-96e0-eba8a31eb245 64058-123 HUMAN OTC DRUG Arthritazin Pain Relieving EZ Capsaicin GEL TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .02825 g/113g 64058-141_0622f620-3b35-4679-b5f2-ff23b1693340 64058-141 HUMAN OTC DRUG MyOmega OMEGA 3PLUS PAIN RELIEF RUB Menthol and Camphor (Synthetic) CREAM TOPICAL 20110817 OTC MONOGRAPH FINAL part348 Concept Laboratories, Inc. CAMPHOR (SYNTHETIC); MENTHOL 6.3; 12.72 g/106g; g/106g 64058-142_975e34f6-6d1e-4697-9b9e-3de9997de87d 64058-142 HUMAN OTC DRUG MyOmega Omega 3plus Targeted Relief Menthol and Camphor (Synthetic) SPRAY TOPICAL 20090303 OTC MONOGRAPH FINAL part348 Concept Laboratories, Inc. CAMPHOR (SYNTHETIC); MENTHOL 7.08; 14.16 g/118mL; g/118mL 64058-145_93157852-e6e9-417a-9844-d8e23328f08f 64058-145 HUMAN OTC DRUG Miracle Plus Diabetic Homeopathic Nerve Pain Reliever ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAF, and CLAVICEPS PURPUREA SCLEROTIUM LIQUID TOPICAL 20100210 UNAPPROVED HOMEOPATHIC Concept Laboratories, Inc. ACONITUM NAPELLUS; CLAVICEPS PURPUREA SCLEROTIUM; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12; 12 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL 64058-146_8b6d77aa-3552-44e3-b0e9-0e792856d44c 64058-146 HUMAN OTC DRUG My Omega Heat Therapy Capsaicin CREAM TOPICAL 20090218 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .0265 g/106g 64058-147_b5de28ee-3b67-4208-929b-73e12d1d7962 64058-147 HUMAN OTC DRUG NanoFreeze Menthol and Camphor (Synthetic) SPRAY TOPICAL 20131014 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAMPHOR (SYNTHETIC); MENTHOL 7.08; 14.16 g/118mL; g/118mL 64058-151_5a7ef586-d0ee-478f-8d69-7c8ff0b2cc23 64058-151 HUMAN OTC DRUG Miracle Plus Homeopathic Skin Tag Remover THUJA OCCIDENTALIS LEAFY TWIG LIQUID TOPICAL 20141103 UNAPPROVED HOMEOPATHIC Concept Laboratories, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/10mL 64058-153_5626ba27-e2ce-4fc1-8273-40dd81792896 64058-153 HUMAN OTC DRUG Omega 3 Heat Therapy Capsaicin GEL TOPICAL 20130711 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .02125 g/85g 64058-154_107a3124-8cd1-4428-8e1d-e44f773d2d2b 64058-154 HUMAN OTC DRUG Charley Horse ARNICA MONTANA, CUPRIC ARSENITE, COPPER, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, and TOXICODENDRON PUBESCENS LEAF CREAM TOPICAL 20140429 UNAPPROVED HOMEOPATHIC Concept Laboratories, Inc. ARNICA MONTANA; COPPER; CUPRIC ARSENITE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF 4; 8; 8; 8; 4 [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g 64058-155_a56b263a-5d26-44fe-a476-4fc6ef6d3913 64058-155 HUMAN OTC DRUG Miracle Plus Overnight Pain Relieving Capsaicin GEL TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .02825 g/113g 64058-211_ffc3a9b1-1c1a-4dab-8b31-167092cd09ec 64058-211 HUMAN OTC DRUG PsoCleer Advanced Psoriasis Salicylic Acid CREAM TOPICAL 20100108 OTC MONOGRAPH FINAL part358H Concept Laboratories, Inc. SALICYLIC ACID 2.26 g/113g 64058-213_c7a71f36-cdb4-4cb8-a9ba-01dc75721a82 64058-213 HUMAN OTC DRUG Fast Arthritis Aid Capsaicin GEL TOPICAL 20100322 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .0615 g/246g 64058-241_d345f290-cb01-4606-a576-173e125f349c 64058-241 HUMAN OTC DRUG Retadolor Penetrating Cool Therapy Menthol and Camphor (Synthetic) CREAM TOPICAL 20090727 OTC MONOGRAPH FINAL part348 Concept Laboratories, Inc. CAMPHOR (SYNTHETIC); MENTHOL 5.1; 10.2 g/85g; g/85g 64058-242_97016a56-35b6-40ba-b43f-fc38775786cf 64058-242 HUMAN OTC DRUG Invisible Pain Menthol and Camphor (Synthetic) SPRAY TOPICAL 20110712 OTC MONOGRAPH FINAL part348 Concept Laboratories, Inc. CAMPHOR (SYNTHETIC); MENTHOL 7.08; 14.16 g/118mL; g/118mL 64058-244_65ff180a-b56f-4729-a5ca-c40dbda8b53a 64058-244 HUMAN OTC DRUG BIO-MEGA MENTHOL and CAMPHOR (SYNTHETIC) CREAM TOPICAL 20140113 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAMPHOR (SYNTHETIC); MENTHOL 14.22; 28.44 g/237mL; g/237mL 64058-245_fc6f7461-3ac0-428f-80bf-c171bb2ea8a1 64058-245 HUMAN OTC DRUG BIO-MEGA Heat Therapy Capsaicin CREAM TOPICAL 20140113 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .05925 g/237mL 64058-314_9d18e48c-5cfe-419b-8a2c-c2042b23319d 64058-314 HUMAN OTC DRUG Invisible Pain Capsaicin CREAM TOPICAL 20110713 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .875 mg/3.5g 64058-342_85794d9d-cb76-42aa-941c-29dfd71687aa 64058-342 HUMAN OTC DRUG Leg Strong Trifusion Menthol and Camphor (Synthetic) SPRAY TOPICAL 20110127 OTC MONOGRAPH FINAL part348 Concept Laboratories, Inc. CAMPHOR (SYNTHETIC); MENTHOL 7.08; 14.16 g/118mL; g/118mL 64058-343_ff63d381-94ec-4583-969a-0437650ed63b 64058-343 HUMAN OTC DRUG Kool Heat Pain Therapy Capsaicin CREAM TOPICAL 20110708 OTC MONOGRAPH FINAL part348 Concept Laboratories, Inc. CAPSAICIN .0295 g/118mL 64058-413_a12868b0-0929-46bf-ba12-a2c531c184a0 64058-413 HUMAN OTC DRUG Fast Arthritis Aid Pain Relieving Capsaicin GEL TOPICAL 20110805 OTC MONOGRAPH FINAL part348 Concept Laboratories, Inc. CAPSAICIN .01425 g/57g 64058-441_cbce9357-e8dd-446b-b78a-4b9c79e7de49 64058-441 HUMAN OTC DRUG Painathol-MC Cool Penetrating Pain Relieving Menthol and Camphor (Synthetic) CREAM TOPICAL 20090611 OTC MONOGRAPH FINAL part348 Concept Laboratories, Inc. CAMPHOR (SYNTHETIC); MENTHOL 15; 30.6 g/255g; g/255g 64058-442_5e9fb3a1-3824-4e3f-8467-6b0de8933757 64058-442 HUMAN OTC DRUG NanoFreeze Menthol and Camphor (Synthetic) SPRAY TOPICAL 20110310 OTC MONOGRAPH FINAL part348 Concept Laboratories, Inc. CAMPHOR (SYNTHETIC); MENTHOL 7.08; 14.16 g/118mL; g/118mL 64058-443_6ae08e08-def9-43d4-97bd-27361e6f25e2 64058-443 HUMAN OTC DRUG Outdoor Hands Capsaicin CREAM TOPICAL 20110708 OTC MONOGRAPH FINAL part348 Concept Laboratories, Inc. CAPSAICIN .0295 g/118mL 64058-514_e46cad92-845d-449d-882d-d39d201235ae 64058-514 HUMAN OTC DRUG Pure Pain Relief Capsaicin CREAM TOPICAL 20130109 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .02825 g/113g 64058-541_8c224047-985e-4059-94b6-0cdfd0e4d137 64058-541 HUMAN OTC DRUG Kymaro Roll on Relief MENTHOL and CAMPHOR (SYNTHETIC) CREAM TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAMPHOR (SYNTHETIC); MENTHOL 5.1; 10.2 g/85g; g/85g 64058-613_734a66a0-e35d-42da-9823-25923280afec 64058-613 HUMAN OTC DRUG Sherman and Clark Pain Relieving Capsaicin GEL TOPICAL 20111206 OTC MONOGRAPH FINAL part348 Concept Laboratories, Inc. CAPSAICIN .06275 g/251mL 64058-615_5787ad93-5189-46d3-908c-aa4d613ccae0 64058-615 HUMAN OTC DRUG Miracle Plus Anti-Fungal Tolnaftate CREAM TOPICAL 20110104 OTC MONOGRAPH FINAL part333C Concept Laboratories, Inc. TOLNAFTATE .59 g/59g 64058-641_669aad1e-63f9-4e27-812a-3101d7d06609 64058-641 HUMAN OTC DRUG Omega 3 Targeted Relief MENTHOL and CAMPHOR (SYNTHETIC) CREAM TOPICAL 20130404 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAMPHOR (SYNTHETIC); MENTHOL 5.1; 10.2 g/85g; g/85g 64058-713_0c924458-2e2a-48ed-af31-48b3ca10cd25 64058-713 HUMAN OTC DRUG Miracle Plus Neck and Shoulder Pain Relief Capsaicin GEL TOPICAL 20120709 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .02825 g/113g 64058-716_21898acb-0660-482f-866a-fa1bea00c8d5 64058-716 HUMAN OTC DRUG Miracle Fade HYDROQUINONE CREAM TOPICAL 20140429 OTC MONOGRAPH NOT FINAL part358A Concept Laboratories, Inc. HYDROQUINONE 1.695 g/113g 64058-813_1939e655-93b2-4783-96e0-eba8a31eb245 64058-813 HUMAN OTC DRUG Arthritazin Pain Relieving Capsaicin GEL TOPICAL 20130117 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .06375 g/255g 64058-913_1939e655-93b2-4783-96e0-eba8a31eb245 64058-913 HUMAN OTC DRUG Arthritazin Pain Relieving Capsaicin GEL TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .02125 g/85g 64064-0002_1e075a8b-8426-4064-a07d-00c793b5ae45 64064-0002 HUMAN OTC DRUG CliniShield Instant Hand Sanitizer Fragrance Free ethanol GEL TOPICAL 20110215 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 70 mL/100mL 64064-002_0321e60d-e053-4583-a789-bd0dc58ccb13 64064-002 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20110906 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 62 mL/100mL 64064-002_193c7816-d76c-4e53-b133-85e49ecbb558 64064-002 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20110906 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 62 mL/100mL 64064-002_71452250-be6e-41c2-bb6b-cd9ee3103b67 64064-002 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20110906 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 62 mL/100mL 64064-002_bff82b2d-eb7b-4d96-9c00-3d53f1892292 64064-002 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20110906 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 62 mL/100mL 64064-003_97384b49-a61b-4529-a306-b6e49daede56 64064-003 HUMAN OTC DRUG Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110906 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 70 mL/100mL 64064-007_12b97e8f-db59-466e-9a68-76b41ef486c3 64064-007 HUMAN OTC DRUG Health Care Personnel Handwash Alcohol LIQUID TOPICAL 20110909 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC TRICLOSAN 1 mL/100mL 64064-050_9319d10f-d283-4e30-830d-1f76abafed50 64064-050 HUMAN OTC DRUG Refresh Foaming Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 68 mL/100mL 64064-050_ad02b319-4b1c-49e1-9c76-44ed35e21c78 64064-050 HUMAN OTC DRUG Refresh Foaming Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 68 mL/100mL 64064-050_bb35699e-d72a-4169-a8aa-3062b1bcce57 64064-050 HUMAN OTC DRUG Refresh Foaming Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 68 mL/100mL 64064-101_1191f5ad-3451-41fd-849f-83a097ba7271 64064-101 HUMAN OTC DRUG Stoko Refresh Triclosan LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC TRICLOSAN .5 g/100mL 64064-105_5a7abb6c-7751-4970-a561-42d5bcc5d863 64064-105 HUMAN OTC DRUG Stoko Refresh Food Handler Foam Triclosan LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC TRICLOSAN .5 g/100mL 64067-216_ac2bd41e-0c66-4449-8e72-49677ff763bf 64067-216 HUMAN PRESCRIPTION DRUG UVADEX Methoxsalen INJECTION, SOLUTION EXTRACORPOREAL 19990225 NDA NDA020969 Therakos, Inc. METHOXSALEN 20 ug/mL Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE],Psoralen [EPC],Psoralens [Chemical/Ingredient] 64069-4111_25ebd23b-eb11-4127-974f-896f4366e421 64069-4111 HUMAN PRESCRIPTION DRUG Oxygen, Compressed U.S.P. Oxygen, Compressed U.S.P. GAS RESPIRATORY (INHALATION) 20100610 UNAPPROVED MEDICAL GAS Techgas Inc. OXYGEN 1 L/L 64092-010_96f14ef6-44b1-471a-a100-7bb9755f6078 64092-010 HUMAN OTC DRUG Somnitabs Diphenhydramine HCl TABLET ORAL 19921225 OTC MONOGRAPH FINAL part341 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 64092-012_04dbd480-55a3-44a7-bb1e-ffd9d327b197 64092-012 HUMAN OTC DRUG Rest Simply Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 64092-020_29c2ee74-9aa9-4f09-b79b-25cd52098295 64092-020 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19921121 OTC MONOGRAPH FINAL part340 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. CAFFEINE 200 mg/1 64092-031_88061bf4-ce03-4e83-8480-72d89bff8fca 64092-031 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050203 OTC MONOGRAPH NOT FINAL part343 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ACETAMINOPHEN 80 mg/1 64092-105_f4d95dd5-c95f-48c7-b779-dbe9a3814938 64092-105 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl CAPSULE ORAL 20050503 ANDA ANDA076497 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 64092-108_e5e62bc4-70f0-455d-a5cf-142e2b80deae 64092-108 HUMAN OTC DRUG HEALTHCARE Instant Hand Sanitizer Vanilla Scent ALCOHOL LIQUID TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part333E GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ALCOHOL 62 mL/100mL 64092-109_8d0218ed-5fba-4d57-966c-72ddf844f494 64092-109 HUMAN OTC DRUG HEALTHCARE Instant Hand Sanitizer Strawberry Scent ALCOHOL LIQUID TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part333E GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ALCOHOL 62 mL/100mL 64092-112_bea7c608-f91d-4cdf-a3d6-c4dcfadd9c0a 64092-112 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 64092-113_a7c898e5-3fbb-4d9b-8f19-c910810aeb2c 64092-113 HUMAN OTC DRUG Health Care Instant Hand Sanitizer Ice Clear ALCOHOL LIQUID TOPICAL 20120328 OTC MONOGRAPH FINAL part333E GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ALCOHOL 62 mL/100mL 64092-115_1ad3e6ea-1351-41ea-80fd-dbd3690ffa69 64092-115 HUMAN OTC DRUG Natural Vegetable Laxative Sennosides TABLET ORAL 19950127 OTC MONOGRAPH NOT FINAL part334 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. SENNOSIDES A AND B 8.6 mg/1 64092-119_fee47188-845f-4317-acd2-68e0a5aeaa3b 64092-119 HUMAN OTC DRUG Enteric Coated Aspirin Aspirin TABLET ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ASPIRIN 81 mg/1 64092-120_3c188b1d-5854-48e8-b92e-ab841fa51112 64092-120 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20000901 OTC MONOGRAPH NOT FINAL part334 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. BISACODYL 5 mg/1 64092-122_2b309ca5-403e-4c4b-8e66-d9c93bf245fd 64092-122 HUMAN OTC DRUG Maximum Strength Menstrual Relief Acetaminophen, Caffeine and Pyrilamine maleate CAPSULE ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 64092-141_bc85e79a-0f81-45a2-ad51-837d2f17e3ba 64092-141 HUMAN OTC DRUG Enteric Aspirin Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH NOT FINAL part343 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ASPIRIN 325 mg/1 64092-150_9bc5147c-e3a4-4966-805a-05ee5d781231 64092-150 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ASPIRIN 81 mg/1 64092-202_cfd6b1e7-ba80-48da-b423-f5246fd5e39f 64092-202 HUMAN OTC DRUG Film Coated Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. IBUPROFEN 200 mg/1 64092-204_f3212afe-2d55-4b19-953d-2d58f4593b8e 64092-204 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, COATED ORAL 19880524 ANDA ANDA075010 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. IBUPROFEN 200 mg/1 64092-218_73f53363-953a-4bb6-af15-c135b09de9ab 64092-218 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ASPIRIN 81 mg/1 64092-312_4f1b2435-8b85-4277-8d30-e6786eaaf143 64092-312 HUMAN OTC DRUG Instant Hand Sanitizer Aloe Vera Ethyl Alcohol GEL TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part333E Great Lakes Wholesale & Marketing, LLC ALCOHOL 146 mL/236mL 64092-313_72a597ac-a286-4922-9367-cf55750547a1 64092-313 HUMAN OTC DRUG Instant Hand Sanitizer - Ice Clear Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Great Lakes Wholesale & Marketing, LLC ALCOHOL 37 mL/60mL 64092-314_552eb511-4126-479d-ba44-f77839e7f1dd 64092-314 HUMAN OTC DRUG Instant Hand Sanitizer - Clear Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Great Lakes Wholesale & Marketing, LLC ALCOHOL 147 mL/237mL 64092-315_b577ddec-a10d-4f76-be71-fcf2344e67bd 64092-315 HUMAN OTC DRUG Instant Hand Sanitizer - Cocoa Butter Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Great Lakes Wholesale & Marketing, LLC ALCOHOL 147 mL/237mL 64092-316_629dd3c1-50e2-4cae-b675-97e504096e60 64092-316 HUMAN OTC DRUG Liquid Hand Cleanse Triclosan GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Great Lakes Wholesale & Marketing, LLC TRICLOSAN 10 mg/500mg 64092-317_b2ce150f-c8b0-4c78-b6c9-37b02169710e 64092-317 HUMAN OTC DRUG Instant Hand Sanitizer - Original Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Great Lakes Wholesale & Marketing, LLC ALCOHOL 33 mL/53mL 64092-318_e796fd20-b92e-4eeb-8102-21e7dfdb2dce 64092-318 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Great Lakes Wholesale & Marketing, LLC ALCOHOL 6 mL/10mL 64092-350_6b6cd076-067f-4d8c-a926-b5abd2ffa7c8 64092-350 HUMAN OTC DRUG Nighttime Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. DOXYLAMINE SUCCINATE 25 mg/1 64092-600_bdf1a0c5-ccc6-4bc0-8e43-c075c5fe7eec 64092-600 HUMAN OTC DRUG Motion Sickness Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. DIMENHYDRINATE 50 mg/1 64092-608_417caf89-6d05-46a3-aba2-f26f107e3fbf 64092-608 HUMAN OTC DRUG Motion Sickness II Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. MECLIZINE HYDROCHLORIDE 25 mg/1 64092-802_bb5626c0-ab89-4ea7-9891-45f7df9ee3be 64092-802 HUMAN OTC DRUG Suphedrine PE Phenylephrine HCl TABLET, COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 64092-820_fd762742-be6e-400e-befe-2f2144734e70 64092-820 HUMAN OTC DRUG Chlor-Tabs Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. CHLORPHENIRAMINE MALEATE 4 mg/1 64092-830_7146b021-2a60-4787-ac39-d28c6396ca11 64092-830 HUMAN OTC DRUG Complete Allergy Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 64092-835_1fbc0a69-0cbc-4645-9451-e594a06f24f4 64092-835 HUMAN OTC DRUG Allerfed Cold and Allergy Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20020722 OTC MONOGRAPH FINAL part341 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 64092-845_a3631937-135b-48da-895e-20df6796dd22 64092-845 HUMAN OTC DRUG Non-Drowsy Sinus Daytime Acetaminophen and Phenylephrine HCl TABLET ORAL 20050726 OTC MONOGRAPH FINAL part341 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 64092-865_402e001c-4aa2-4ba6-8804-d0b352a2c75d 64092-865 HUMAN OTC DRUG Complete Allery and Sinus Multi-Symptom Acetaminophen, Chlorpheniramine Maleate and Phenylephrine HCl TABLET ORAL 20060530 OTC MONOGRAPH NOT FINAL part343 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 64092-870_d23170df-2237-4e4a-a396-250b5e4504d3 64092-870 HUMAN OTC DRUG Multi-Symptom Cold Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050715 OTC MONOGRAPH FINAL part341 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 64097-0001_8def91d4-8ccf-457f-96c5-f643130ca8a5 64097-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Alternacare Home Health Services OXYGEN 99.5 L/100L 64108-212_8c08a421-0e2e-4acb-a3d6-ae439a28597c 64108-212 HUMAN OTC DRUG MiniDrops Lubricant eye drops LIQUID OPHTHALMIC 19910401 OTC MONOGRAPH FINAL part349 Optics Laboratory, Inc POLYVINYL ALCOHOL; POVIDONE K30 1.4; .6 mL/100mL; mL/100mL 64108-313_d1d95984-b49e-44a4-ab8a-1e348e3194de 64108-313 HUMAN OTC DRUG OCUFRESH Water LIQUID OPHTHALMIC 20140115 OTC MONOGRAPH FINAL part349 Optics Laboratory Inc. WATER .988 mL/mL 64116-011_94707fd1-9572-46d1-88c9-15bc86bba701 64116-011 HUMAN PRESCRIPTION DRUG ACTIMMUNE Interferon gamma-1b INJECTION, SOLUTION SUBCUTANEOUS 19990225 20150331 BLA BLA103836 InterMune, Inc. INTERFERON GAMMA-1B 100 ug/.5mL Interferon gamma [EPC],Interferon-gamma [Chemical/Ingredient] 64116-121_58cc9885-2828-435d-9db2-8e94cdecfa00 64116-121 HUMAN PRESCRIPTION DRUG Esbriet pirfenidone CAPSULE ORAL 20141016 NDA NDA022535 InterMune, Inc. PIRFENIDONE 267 mg/1 64117-052_681e9d88-433b-4cad-abc5-433c3520647e 64117-052 HUMAN OTC DRUG NEURALGIA HEADACHE ZINC PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ZINC 30 [hp_C]/mL 64117-100_c5fb97a1-da63-471d-98be-87f8d1915a10 64117-100 HUMAN OTC DRUG Indigestion ARTEMISIA ABROTANUM FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARTEMISIA ABROTANUM FLOWERING TOP 30 [hp_C]/mL 64117-101_2157f54d-1c49-487c-861b-693b4eb34630 64117-101 HUMAN OTC DRUG Rheumatism ACTAEA SPICATA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ACTAEA SPICATA ROOT 30 [hp_C]/mL 64117-102_3a0658f7-b48f-4f24-a33b-9b9d379aa2db 64117-102 HUMAN OTC DRUG Vomiting Diarrhea AETHUSA CYNAPIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AETHUSA CYNAPIUM 30 [hp_C]/mL 64117-103_ce7a8cfc-c459-4508-afef-1828a7400dda 64117-103 HUMAN OTC DRUG Sprains Strains CHASTE TREE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CHASTE TREE 30 [hp_C]/mL 64117-104_f64df010-caa6-4f2f-91c4-e89472285e87 64117-104 HUMAN OTC DRUG Skin Rash Acne AILANTHUS ALTISSIMA FLOWERING TWIG PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AILANTHUS ALTISSIMA FLOWERING TWIG 30 [hp_C]/mL 64117-105_52c65d8d-bcf2-46bf-a700-95fcf0ed1416 64117-105 HUMAN OTC DRUG Nervous Cough AMBERGRIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AMBERGRIS 30 [hp_C]/mL 64117-106_b47d136e-83a4-4755-980a-66765f6b7516 64117-106 HUMAN OTC DRUG Hoarse Cough AMMONIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AMMONIUM CATION 30 [hp_C]/mL 64117-107_fb86fdd9-ecc6-4ad4-884a-c78eda387bdb 64117-107 HUMAN OTC DRUG Rheumatism ANGOSTURA BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ANGOSTURA BARK 30 [hp_C]/mL 64117-108_1ff290be-911f-41fe-97b2-9fc74dfb5735 64117-108 HUMAN OTC DRUG Headache Cough ARSENIC TRIIODIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARSENIC TRIIODIDE 30 [hp_C]/mL 64117-109_f3ff8ed0-4f07-4b7f-808f-3c1ea9016d2d 64117-109 HUMAN OTC DRUG Burning Runny Nose ARISAEMA TRIPHYLLUM ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARISAEMA TRIPHYLLUM ROOT 30 [hp_C]/mL 64117-110_e090f79d-a90c-464d-aafb-d69152a9c75f 64117-110 HUMAN OTC DRUG Flatulence ASAFETIDA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ASAFETIDA 30 [hp_C]/mL 64117-111_823ebed5-b8ac-4960-8a60-24a2bfe78b27 64117-111 HUMAN OTC DRUG Nervous Headache ASARUM EUROPAEUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ASARUM EUROPAEUM 30 [hp_C]/mL 64117-112_c8a77e5b-729f-45d4-9f2b-b3c6f9216f50 64117-112 HUMAN OTC DRUG Acne ASTERIAS RUBENS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ASTERIAS RUBENS 30 [hp_C]/mL 64117-113_7465805c-dac0-48db-81b4-605905424276 64117-113 HUMAN OTC DRUG Slow Digestion Diarrhea GOLD TRICHLORIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GOLD TRICHLORIDE 30 [hp_C]/mL 64117-114_68bb8dfb-84f6-4c86-92a8-35bbc499dbf0 64117-114 HUMAN OTC DRUG Dyspepsia BARIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BARIUM CATION 30 [hp_C]/mL 64117-115_24d51928-1f7f-466c-9585-5ab40c6ee909 64117-115 HUMAN OTC DRUG Rheumatism Diarrhea BENZOIC ACID PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BENZOIC ACID 30 [hp_C]/mL 64117-116_de88e126-296b-47d6-8a77-d792edc51246 64117-116 HUMAN OTC DRUG Colitis BISMUTH PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BISMUTH 30 [hp_C]/mL 64117-117_81fc51d5-c36b-48f9-ad3b-0af04f220353 64117-117 HUMAN OTC DRUG Cough BLATTA ORIENTALIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BLATTA ORIENTALIS 30 [hp_C]/mL 64117-118_414258a1-b325-493b-9f44-218e8b8609e1 64117-118 HUMAN OTC DRUG Dry Cough Diarrhea SODIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SODIUM CATION 30 [hp_C]/mL 64117-119_4a2cc23b-a529-43b0-888d-67785aa7d87e 64117-119 HUMAN OTC DRUG Eczema Headache GIANT PUFFBALL PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GIANT PUFFBALL 30 [hp_C]/mL 64117-120_6d69125f-442b-4908-8164-51d9f15e9ffd 64117-120 HUMAN OTC DRUG Rheumatic Pains BUFO BUFO CUTANEOUS GLAND PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BUFO BUFO CUTANEOUS GLAND 30 [hp_C]/mL 64117-121_39c82341-fcb8-47ad-80cb-c30b2b06eeaf 64117-121 HUMAN OTC DRUG Indigestion CADMIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CADMIUM 30 [hp_C]/mL 64117-122_13441ad6-f4e6-4d36-ab69-78fa89bbc496 64117-122 HUMAN OTC DRUG Skin Irritation DIEFFENBACHIA SEGUINE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply DIEFFENBACHIA SEGUINE 30 [hp_C]/mL 64117-123_e332cd32-d0d5-4c28-b531-9d6bb95407ec 64117-123 HUMAN OTC DRUG Flatulence CALCIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALCIUM CATION 30 [hp_C]/mL 64117-124_80b479fb-f69a-4095-8937-83a96b27cae9 64117-124 HUMAN OTC DRUG Eczema Skin Eruptions CALCIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALCIUM CATION 30 [hp_C]/mL 64117-125_6d9e9c97-92cd-4145-8f33-abe279e58e61 64117-125 HUMAN OTC DRUG Common Cold CAMPHOR (NATURAL) PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CAMPHOR (NATURAL) 30 [hp_C]/mL 64117-126_6575fb79-ae4a-490c-ac6e-3b2e89cc9a07 64117-126 HUMAN OTC DRUG Sore Throat headache CAPSICUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CAPSICUM 30 [hp_C]/mL 64117-127_51e9c972-a35a-47d5-b5ac-951d317cd6a8 64117-127 HUMAN OTC DRUG Flatulence CARBO ANIMALIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CARBO ANIMALIS 30 [hp_C]/mL 64117-128_8ea367e7-8141-4248-858b-9fe66002f383 64117-128 HUMAN OTC DRUG Warts EQUUS CABALLUS SKIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply EQUUS CABALLUS SKIN 30 [hp_C]/mL 64117-129_2438f7f8-1d25-408d-abc4-49fcc0d9f6a1 64117-129 HUMAN OTC DRUG Diarrhea CEANOTHUS AMERICANUS LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CEANOTHUS AMERICANUS LEAF 30 [hp_C]/mL 64117-130_a5aeee17-13f7-4b31-a018-3232153bf0ed 64117-130 HUMAN OTC DRUG Billiousness CHELIDONIUM MAJUS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CHELIDONIUM MAJUS 30 [hp_C]/mL 64117-131_9ed03e72-e98c-4677-bb21-ddd4bc7ac7b6 64117-131 HUMAN OTC DRUG Headache CHIONANTHUS VIRGINICUS BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CHIONANTHUS VIRGINICUS BARK 30 [hp_C]/mL 64117-132_aebb7f96-0147-4245-a14e-8db774119e9a 64117-132 HUMAN OTC DRUG Skin Eruptions CICUTA VIROSA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CICUTA VIROSA ROOT 30 [hp_C]/mL 64117-133_33f796d8-b28d-4f89-a1a6-c338f2009939 64117-133 HUMAN OTC DRUG Skin Eruptions CLEMATIS RECTA FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CLEMATIS RECTA FLOWERING TOP 30 [hp_C]/mL 64117-134_535c933a-2708-4a03-8048-87983def939e 64117-134 HUMAN OTC DRUG Skin Eruptions Cough PROTORTONIA CACTI PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PROTORTONIA CACTI 30 [hp_C]/mL 64117-135_cbdcfa56-6b52-413d-bac5-20db7b3848b2 64117-135 HUMAN OTC DRUG Rheumatism COLCHICUM AUTUMNALE BULB PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply COLCHICUM AUTUMNALE BULB 30 [hp_C]/mL 64117-136_1b018e36-b868-4339-837f-ef6cd78f73f1 64117-136 HUMAN OTC DRUG Nausea Vomiting MARSDENIA CONDURANGO BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MARSDENIA CONDURANGO BARK 30 [hp_C]/mL 64117-137_12880526-383b-4e86-a089-2295a6ef5ab9 64117-137 HUMAN OTC DRUG Dysmenorrhea Headache SAFFRON PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SAFFRON 30 [hp_C]/mL 64117-138_5a68655c-1239-42a2-a471-a4d801ad601e 64117-138 HUMAN OTC DRUG Diarrhea CROTON OIL PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CROTON OIL 30 [hp_C]/mL 64117-139_f69a3431-9bc7-432b-b0f7-529840bb6c24 64117-139 HUMAN OTC DRUG Nausea Headache DIGITALIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply DIGITALIS 30 [hp_C]/mL 64117-140_1c811d3d-d5d3-4460-bb31-1ad65d0ccdc7 64117-140 HUMAN OTC DRUG Cough Flu SOLANUM DULCAMARA TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SOLANUM DULCAMARA TOP 30 [hp_C]/mL 64117-141_169ae6b1-ebdc-46fc-8575-f01fae89ea1f 64117-141 HUMAN OTC DRUG Carbuncles Boils ECHINACEA ANGUSTIFOLIA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ECHINACEA ANGUSTIFOLIA 30 [hp_C]/mL 64117-142_9cc8950e-ccb6-4190-95e7-df56d5153c05 64117-142 HUMAN OTC DRUG Incontinence EQUISETUM HYEMALE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply EQUISETUM HYEMALE 30 [hp_C]/mL 64117-143_09598590-5077-4612-b32d-ff7658c6d276 64117-143 HUMAN OTC DRUG Colds Flu EUPATORIUM PERFOLIATUM FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply EUPATORIUM PERFOLIATUM FLOWERING TOP 30 [hp_C]/mL 64117-144_3943b822-6915-4b8e-ba74-80bcfe31a630 64117-144 HUMAN OTC DRUG Nasal Catarrh FORMALDEHYDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply FORMALDEHYDE 30 [hp_C]/mL 64117-145_63bb3ca5-38a6-4498-9c42-0ad4e6867b36 64117-145 HUMAN OTC DRUG Vomiting Diarrhea PSEUDOGNAPHALIUM OBTUSIFOLIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PSEUDOGNAPHALIUM OBTUSIFOLIUM 30 [hp_C]/mL 64117-146_0f3eb74e-5894-4708-b352-134926f7fc5d 64117-146 HUMAN OTC DRUG Nausea GOSSYPIUM HERBACEUM ROOT BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GOSSYPIUM HERBACEUM ROOT BARK 30 [hp_C]/mL 64117-147_31fb6a0f-e5ad-43ff-81cf-beb7d0316642 64117-147 HUMAN OTC DRUG Toothache Neuralgia HEKLA LAVA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HEKLA LAVA 30 [hp_C]/mL 64117-148_7146bd3b-449d-4b99-879b-b9072dae721c 64117-148 HUMAN OTC DRUG Dry Cough IODINE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply IODINE 30 [hp_C]/mL 64117-149_0a4c9220-aeb9-48b7-b4d6-9620e09226fa 64117-149 HUMAN OTC DRUG RHEUMATISM, NAUSEA JACARANDA CAROBA FLOWER PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply JACARANDA CAROBA FLOWER 30 [hp_C]/mL 64117-150_65e6934d-c244-4858-8d16-bc267bc80e4a 64117-150 HUMAN OTC DRUG Skin Affections POTASSIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM CATION 30 [hp_C]/mL 64117-151_44d4af1c-33db-49b7-957b-73196e6d49c2 64117-151 HUMAN OTC DRUG Insomnia POTASSIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM CATION 30 [hp_C]/mL 64117-152_cfa77971-5fa8-4d6b-8321-d043747cf8f7 64117-152 HUMAN OTC DRUG Colds Dry Cough Potassium Cation PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM CATION 30 [hp_C]/mL 64117-153_339f9359-8be4-4761-97a9-9fde1f9d77b7 64117-153 HUMAN OTC DRUG Runny Nose Warts Potassium Cation PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM CATION 30 [hp_C]/mL 64117-154_4ac9f09c-6b5c-41db-9177-6f0d72cb1aca 64117-154 HUMAN OTC DRUG Headache Nervousness Potassium Cation PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM CATION 30 [hp_C]/mL 64117-155_0c89aa39-d29b-4fc7-9859-18bc4f21fe3a 64117-155 HUMAN OTC DRUG Sun Headache Rheumatism KALMIA LATIFOLIA LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply KALMIA LATIFOLIA LEAF 30 [hp_C]/mL 64117-156_1b1459b3-a4eb-4f1c-9352-c5af66d897ba 64117-156 HUMAN OTC DRUG Tickling Cough LACTUCA VIROSA LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LACTUCA VIROSA LEAF 30 [hp_C]/mL 64117-157_9eadee3d-60ed-4ab7-a3ac-c179ef7731cd 64117-157 HUMAN OTC DRUG Heartburn PRUNUS LAUROCERASUS LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PRUNUS LAUROCERASUS LEAF 30 [hp_C]/mL 64117-158_392e5bcc-4386-4b0e-beac-7715a6d22c70 64117-158 HUMAN OTC DRUG Cough Hay Fever LOBELIA INFLATA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LOBELIA INFLATA 30 [hp_C]/mL 64117-159_74b9dd35-fbbc-4fc2-b760-f14700abc19d 64117-159 HUMAN OTC DRUG Diarrhea Dyspepsia MAGNESIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MAGNESIUM CATION 30 [hp_C]/mL 64117-160_9b7650a7-9f8c-4d3d-969f-adcc16545e90 64117-160 HUMAN OTC DRUG Constipation Billousness MAGNESIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MAGNESIUM CATION 30 [hp_C]/mL 64117-161_b743000c-f764-475f-9bc3-dd74462bd4ce 64117-161 HUMAN OTC DRUG Headache HIPPOMANE MANCINELLA FRUITING LEAFY TWIG PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HIPPOMANE MANCINELLA FRUITING LEAFY TWIG 30 [hp_C]/mL 64117-162_3eda8c57-d2db-47f9-bd97-a528093b8bdb 64117-162 HUMAN OTC DRUG Headache Spasms MELILOTUS OFFICINALIS TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MELILOTUS OFFICINALIS TOP 30 [hp_C]/mL 64117-163_5b2aa810-a6c2-4045-af8d-f6ac5e750ba9 64117-163 HUMAN OTC DRUG SPASMODIC COUGH MEPHITIS MEPHITIS ANAL GLAND FLUID PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MEPHITIS MEPHITIS ANAL GLAND FLUID 30 [hp_C]/mL 64117-164_eb8bf9e9-e665-45be-a048-f100a793554d 64117-164 HUMAN OTC DRUG Sore Throat Diarrhea MERCURIC CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MERCURIC CATION 30 [hp_C]/mL 64117-165_f75bd644-73fa-4dcf-ab04-fc23b7da2e56 64117-165 HUMAN OTC DRUG Sore Throat Right Side MERCUROUS IODIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MERCUROUS IODIDE 30 [hp_C]/mL 64117-166_731a5870-d6a2-4310-b117-af424b273a04 64117-166 HUMAN OTC DRUG Sore Throat Left Side MERCURIC IODIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MERCURIC IODIDE 30 [hp_C]/mL 64117-167_8dfd3510-4ab2-4fd4-9d70-c5a4d2405d67 64117-167 HUMAN OTC DRUG SORE THROAT VIROLA SEBIFERA RESIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VIROLA SEBIFERA RESIN 30 [hp_C]/mL 64117-168_38b92836-5f72-4f5d-9883-e938302bad23 64117-168 HUMAN OTC DRUG Indigestion Diarrhea NUTMEG PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply NUTMEG 30 [hp_C]/mL 64117-169_c2b66ec3-82f8-4a4f-a9f3-110bcaf97998 64117-169 HUMAN OTC DRUG Headache ORIGANUM MAJORANA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ORIGANUM MAJORANA 30 [hp_C]/mL 64117-170_a8cc9907-aa83-4ae3-9994-dee59c131cc0 64117-170 HUMAN OTC DRUG Constipation PALLADIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PALLADIUM 30 [hp_C]/mL 64117-171_62eac367-a3e8-425a-af73-ce4e6693e133 64117-171 HUMAN OTC DRUG Profuse Sweating PILOCARPUS JABORANDI LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PILOCARPUS JABORANDI LEAF 30 [hp_C]/mL 64117-172_bdcc8441-86e7-4feb-9f6c-fb67d93cdb59 64117-172 HUMAN OTC DRUG Diarrhea QUERCUS ROBUR NUT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply QUERCUS ROBUR NUT 30 [hp_C]/mL 64117-173_cbb878cc-2586-4338-b004-85597a765e80 64117-173 HUMAN OTC DRUG Rheumatism RADIUM BROMIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply RADIUM BROMIDE 30 [hp_C]/mL 64117-174_8b78810d-ce99-462b-aeae-0b74ee91928f 64117-174 HUMAN OTC DRUG Hemmorrhoids KRAMERIA LAPPACEA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply KRAMERIA LAPPACEA ROOT 30 [hp_C]/mL 64117-175_0424b91c-e4ac-442d-b48a-9ed563c7fa07 64117-175 HUMAN OTC DRUG Diarrhea RHEUM OFFICINALE ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply RHEUM OFFICINALE ROOT 30 [hp_C]/mL 64117-176_6a4a76f7-5072-42b9-9524-f6cdc6cfbe5f 64117-176 HUMAN OTC DRUG Hay Fever SCHOENOCAULON OFFICINALE SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SCHOENOCAULON OFFICINALE SEED 30 [hp_C]/mL 64117-177_7b739de3-f2d6-4eb5-b882-9c359af06223 64117-177 HUMAN OTC DRUG Painful Urination SAW PALMETTO PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SAW PALMETTO 30 [hp_C]/mL 64117-178_5d54f65a-342a-4f26-a954-a3efbdddd671 64117-178 HUMAN OTC DRUG Cough Perspiration SAMBUCUS NIGRA FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SAMBUCUS NIGRA FLOWERING TOP 30 [hp_C]/mL 64117-179_cbaddbac-27f1-4381-84a8-9fc4f4d704bf 64117-179 HUMAN OTC DRUG Boils Eczema SARSAPARILLA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SARSAPARILLA ROOT 30 [hp_C]/mL 64117-180_6e217959-d70d-4ffb-a315-f9712139acaa 64117-180 HUMAN OTC DRUG Hemmorrhoids SCROPHULARIA NODOSA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SCROPHULARIA NODOSA 30 [hp_C]/mL 64117-181_5eb0799c-9abe-429c-b743-4200c9e5d523 64117-181 HUMAN OTC DRUG Headache CLAVICEPS PURPUREA SCLEROTIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CLAVICEPS PURPUREA SCLEROTIUM 30 [hp_C]/mL 64117-182_2c265a3a-b361-46c5-8ebb-5615c5d6dcf4 64117-182 HUMAN OTC DRUG Hoarse Cough SELENIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SELENIUM 30 [hp_C]/mL 64117-183_ecfe8d25-35ad-4272-a888-58289d1a669a 64117-183 HUMAN OTC DRUG Cough Thick Mucous POLYGALA SENEGA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POLYGALA SENEGA ROOT 30 [hp_C]/mL 64117-184_17e7a885-a72f-4c53-8383-01790fa65a9d 64117-184 HUMAN OTC DRUG Hoarse Cough TIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TIN 30 [hp_C]/mL 64117-185_b456fa8c-e503-4985-b5be-905a51ac5cbb 64117-185 HUMAN OTC DRUG Cough Colds LOBARIA PULMONARIA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LOBARIA PULMONARIA 30 [hp_C]/mL 64117-186_bea72c95-6eb6-424a-a8a7-78ed555d52f9 64117-186 HUMAN OTC DRUG Dyspepsia STRONTIUM BROMIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply STRONTIUM BROMIDE 30 [hp_C]/mL 64117-187_a87da41d-c780-46b1-aade-ee7721aef51b 64117-187 HUMAN OTC DRUG Indigestion With Nausea STROPHANTHUS HISPIDUS SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply STROPHANTHUS HISPIDUS SEED 30 [hp_C]/mL 64117-188_f9252d09-e439-43ff-b6ce-b5c747f4c8ba 64117-188 HUMAN OTC DRUG Acne Skin eruptions SULFUR IODIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SULFUR IODIDE 30 [hp_C]/mL 64117-189_128961f6-4bb5-4d16-9b2e-bf471184c1d7 64117-189 HUMAN OTC DRUG Colds Flu SULFURIC ACID PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SULFURIC ACID 30 [hp_C]/mL 64117-190_39ef761f-9a41-4bd2-9396-72d1bcf4527d 64117-190 HUMAN OTC DRUG Gastric Headache TARAXACUM OFFICINALE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TARAXACUM OFFICINALE 30 [hp_C]/mL 64117-191_be74d851-4534-4c05-95e6-1c017ce2955f 64117-191 HUMAN OTC DRUG Sore Throat headache TURPENTINE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TURPENTINE 30 [hp_C]/mL 64117-192_274a0221-e6fc-4e87-899f-61bb74cfd081 64117-192 HUMAN OTC DRUG NHS Insomnia 4 CAMELLIA SINENSIS FLOWER PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CAMELLIA SINENSIS FLOWER 30 [hp_C]/mL 64117-193_41368e1b-bf26-4a05-a722-ad7001e15f49 64117-193 HUMAN OTC DRUG Menstrual Headache USTILAGO MAYDIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply USTILAGO MAYDIS 30 [hp_C]/mL 64117-194_947a2b52-8bcb-43ea-aaab-42410716fe3c 64117-194 HUMAN OTC DRUG Insomnia Nervousness VALERIAN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VALERIAN 30 [hp_C]/mL 64117-195_213184ad-3fec-4e90-a0f2-51463fa78adf 64117-195 HUMAN OTC DRUG Painful Menstruation VIBURNUM OPULUS BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VIBURNUM OPULUS BARK 30 [hp_C]/mL 64117-196_3971ee98-01cc-4fbc-9ad1-30f5011ffa33 64117-196 HUMAN OTC DRUG Menopause VIPERA BERUS VENOM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VIPERA BERUS VENOM 30 [hp_C]/mL 64117-197_7e1b8350-cfbf-4b17-b2e7-784be24c7fcc 64117-197 HUMAN OTC DRUG Rheumatism Cough VISCUM ALBUM FRUITING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VISCUM ALBUM FRUITING TOP 30 [hp_C]/mL 64117-198_d0725efe-f074-4e18-87dd-e72c00bd50b9 64117-198 HUMAN OTC DRUG Sore Throat Dry Cough WYETHIA HELENIOIDES ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply WYETHIA HELENIOIDES ROOT 30 [hp_C]/mL 64117-199_83f376af-0be2-4712-8afc-e9aca1b2fdde 64117-199 HUMAN OTC DRUG FATIGUE LACTOSE, X-RAY EXPOSED (1000 RAD) PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LACTOSE, X-RAY EXPOSED (1000 RAD) 30 [hp_C]/mL 64117-200_f8d961ec-02b8-4733-872a-ea5c07ed259b 64117-200 HUMAN OTC DRUG DYSPEPSIA 3 PICEA MARIANA RESIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PICEA MARIANA RESIN 30 [hp_C]/mL 64117-201_8fcace97-80e3-4426-813f-e2fd1eeefb91 64117-201 HUMAN OTC DRUG NERVOUSNESS EXCITEMENT WORMWOOD PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply WORMWOOD 30 [hp_C]/mL 64117-202_8814e8a4-5635-46dd-be0b-bfc6119a9ab1 64117-202 HUMAN OTC DRUG DYSPEPSIA FATIGUE ACETIC ACID PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ACETIC ACID 30 [hp_C]/mL 64117-203_0f883659-9ca2-4c20-bfc8-6fbbd18a2833 64117-203 HUMAN OTC DRUG HAY FEVER 1 AMBROSIA ARTEMISIIFOLIA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AMBROSIA ARTEMISIIFOLIA 30 [hp_C]/mL 64117-204_b4129b37-6d0c-496b-8869-adbb87b2069b 64117-204 HUMAN OTC DRUG COLDS COUGHS AMMONIUM CHLORIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AMMONIUM CHLORIDE 30 [hp_C]/mL 64117-205_7382c492-d154-46d8-84e7-e678071320da 64117-205 HUMAN OTC DRUG SKIN ERUPTIONS 7 BACILLUS ANTHRACIS IMMUNOSERUM RABBIT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 30 [hp_C]/mL 64117-206_c7bc457c-86b8-4dd7-8f0f-05a000d2c30c 64117-206 HUMAN OTC DRUG RHEUMATIC PAINS 1 APOCYNUM CANNABINUM ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply APOCYNUM CANNABINUM ROOT 30 [hp_C]/mL 64117-207_e8c173dc-60af-4c6f-96c5-c6cc14729e41 64117-207 HUMAN OTC DRUG RHEUMATISM LARYNGITIS SILVER PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SILVER 30 [hp_C]/mL 64117-208_2fb20527-9c31-4578-ad31-6458dce8e719 64117-208 HUMAN OTC DRUG ACNE ARSENIC TRIBROMIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARSENIC TRIBROMIDE 30 [hp_C]/mL 64117-209_6db50402-6344-453b-8b04-595fc12e0d33 64117-209 HUMAN OTC DRUG MUSCLE CRAMPS ARTEMISIA VULGARIS ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARTEMISIA VULGARIS ROOT 30 [hp_C]/mL 64117-210_4c6053fe-7d44-4a5e-b25e-55251a930e44 64117-210 HUMAN OTC DRUG HEADACHE FLATULENCE ASCLEPIAS TUBEROSA FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ASCLEPIAS TUBEROSA FLOWERING TOP 30 [hp_C]/mL 64117-211_5cf13e14-baab-4539-aaab-982a8a0abb2a 64117-211 HUMAN OTC DRUG HEADACHE INSOMNIA BENZENE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BENZENE 30 [hp_C]/mL 64117-212_86ab6a75-6e5a-4394-9e58-561c559b8421 64117-212 HUMAN OTC DRUG COUGH SORE THROAT BROMINE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BROMINE 30 [hp_C]/mL 64117-213_9d873a12-55fb-422a-b96a-cde43680d342 64117-213 HUMAN OTC DRUG HEADACHE CALCIUM ARSENATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALCIUM ARSENATE 30 [hp_C]/mL 64117-214_69a0c290-3cfc-451a-8fd9-b86e27bf154a 64117-214 HUMAN OTC DRUG HEAD COLD CALCIUM SILICATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALCIUM SILICATE 30 [hp_C]/mL 64117-215_40ab1ef3-199c-48cb-be86-d803a8e8ba23 64117-215 HUMAN OTC DRUG HEADACHE RHEUMATISM CARBON DISULFIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CARBON DISULFIDE 30 [hp_C]/mL 64117-216_13022416-d710-4b04-b42f-c3bf7b1105ef 64117-216 HUMAN OTC DRUG SCIATICA RHEUMATISM SILYBUM MARIANUM SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SILYBUM MARIANUM SEED 30 [hp_C]/mL 64117-217_a80068dc-b334-4e07-8034-24558278d740 64117-217 HUMAN OTC DRUG HEADACHE ANXIETY AGKISTRODON CONTORTRIX VENOM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AGKISTRODON CONTORTRIX VENOM 30 [hp_C]/mL 64117-218_41f2d46f-26e3-47a0-8c9f-721111518db2 64117-218 HUMAN OTC DRUG RINGING IN EARS CHENOPODIUM AMBROSIOIDES PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CHENOPODIUM AMBROSIOIDES 30 [hp_C]/mL 64117-219_abaa0f85-b083-49ce-97a4-0d2c8fd93579 64117-219 HUMAN OTC DRUG SKIN ERUPTIONS CHIMAPHILA UMBELLATA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CHIMAPHILA UMBELLATA 30 [hp_C]/mL 64117-220_fb164ac6-a326-469d-92fc-97362b647512 64117-220 HUMAN OTC DRUG HEADACHE QUININE ARSENITE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply QUININE ARSENITE 30 [hp_C]/mL 64117-221_5cacc40e-3d42-4156-a476-6f176ee81f8b 64117-221 HUMAN OTC DRUG SORE THROAT DIARRHEA HELIANTHEMUM CANADENSE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HELIANTHEMUM CANADENSE 30 [hp_C]/mL 64117-222_3dee264e-ed45-46d4-ba56-f0266122a355 64117-222 HUMAN OTC DRUG DIARRHEA VOMITING CUPRIC ARSENITE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CUPRIC ARSENITE 30 [hp_C]/mL 64117-223_c3464c37-bf9e-43d0-be23-91bba00b8cc0 64117-223 HUMAN OTC DRUG HEADACHE VOMITING CYCLAMEN PURPURASCENS TUBER PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CYCLAMEN PURPURASCENS TUBER 30 [hp_C]/mL 64117-224_f5e19fc0-0384-45cd-8a87-7eedfb6e88b0 64117-224 HUMAN OTC DRUG HEADACHE FATIGUE TURNERA DIFFUSA LEAFY TWIG PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TURNERA DIFFUSA LEAFY TWIG 30 [hp_C]/mL 64117-225_4947fa22-d893-449a-b5ec-05a0e16ec712 64117-225 HUMAN OTC DRUG COLIC DIOSCOREA VILLOSA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply DIOSCOREA VILLOSA ROOT 30 [hp_C]/mL 64117-226_5e0dcb92-b777-4e50-b5b9-73b98139650f 64117-226 HUMAN OTC DRUG IRRITABLE BLADDER FEVER EUTROCHIUM PURPUREUM ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply EUTROCHIUM PURPUREUM ROOT 30 [hp_C]/mL 64117-227_6e4418bb-5cc0-4b69-bd6d-1a4994bef89f 64117-227 HUMAN OTC DRUG DRY COUGH SKIN ERUPTIONS EUPHORBIA RESINIFERA RESIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply EUPHORBIA RESINIFERA RESIN 30 [hp_C]/mL 64117-228_c205bbfd-1228-4eab-a153-f640deb69e41 64117-228 HUMAN OTC DRUG ITCHY SKIN RUNNY NOSE FAGOPYRUM ESCULENTUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply FAGOPYRUM ESCULENTUM 30 [hp_C]/mL 64117-229_a6119666-56f8-4bc9-abe8-4ab6c948be28 64117-229 HUMAN OTC DRUG SKIN ERUPTIONS RUNNY NOSE FERROUS IODIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply FERROUS IODIDE 30 [hp_C]/mL 64117-230_4fe4487c-0c03-4595-868d-c0a07953907c 64117-230 HUMAN OTC DRUG WARTS FERRIC PICRATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply FERRIC PICRATE 30 [hp_C]/mL 64117-231_ef2d5930-3084-45f0-90b8-e1f9678f527c 64117-231 HUMAN OTC DRUG ARTHRITIS PAIN FORMIC ACID PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply FORMIC ACID 30 [hp_C]/mL 64117-232_be99724e-cdca-470a-b4c6-a6fdbfdffda9 64117-232 HUMAN OTC DRUG DIARRHEA COLIC GAMBOGE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GAMBOGE 30 [hp_C]/mL 64117-233_8aac5525-efd3-42c6-ad40-b0de97296eb5 64117-233 HUMAN OTC DRUG COLDS RUNNY NOSE GLYCERIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GLYCERIN 30 [hp_C]/mL 64117-234_a18840ac-ba52-42e6-a8bd-cc09d6579543 64117-234 HUMAN OTC DRUG STOMACH CRAMPS GRATIOLA OFFICINALIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GRATIOLA OFFICINALIS 30 [hp_C]/mL 64117-235_f5197b0a-8105-4f26-9ad9-d3187fe1e664 64117-235 HUMAN OTC DRUG ITCHY SKIN RASH GRINDELIA HIRSUTULA FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GRINDELIA HIRSUTULA FLOWERING TOP 30 [hp_C]/mL 64117-236_3cf2aa14-8d5b-45bd-9962-b0480339884f 64117-236 HUMAN OTC DRUG COLDS NAUSEA VOMITING HELIANTHUS ANNUUS FLOWER PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HELIANTHUS ANNUUS FLOWER 30 [hp_C]/mL 64117-237_b57e87f9-2a58-412e-af40-6391a7efa854 64117-237 HUMAN OTC DRUG RHEUMATIC PAINS CHAMAELIRIUM LUTEUM ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CHAMAELIRIUM LUTEUM ROOT 30 [hp_C]/mL 64117-238_a795b7da-6fa3-4887-963f-56ab0efcf582 64117-238 HUMAN OTC DRUG PAINFUL COUGH COLIC STAR ANISE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply STAR ANISE 30 [hp_C]/mL 64117-239_d2fbcfdd-1f3b-4130-b5c9-c37d33db7b01 64117-239 HUMAN OTC DRUG HEADACHE SORE THROAT INDIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply INDIUM 30 [hp_C]/mL 64117-240_887e4c5b-3267-4496-acd7-03ca664ac26b 64117-240 HUMAN OTC DRUG WEAKNESS IRIDIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply IRIDIUM 30 [hp_C]/mL 64117-241_6d912b4b-51f8-4122-9bf6-b70d2cfecb7b 64117-241 HUMAN OTC DRUG HEADACHE VOMITING IRIS VERSICOLOR ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply IRIS VERSICOLOR ROOT 30 [hp_C]/mL 64117-242_65a07785-7fe7-41fc-9fac-75debe7cf7e1 64117-242 HUMAN OTC DRUG COLIC DIARRHEA IPOMOEA PURGA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply IPOMOEA PURGA ROOT 30 [hp_C]/mL 64117-243_75724a59-d976-4970-8a9a-dbbc83bbed2a 64117-243 HUMAN OTC DRUG STOMACH CRAMPS JATROPHA CURCAS SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply JATROPHA CURCAS SEED 30 [hp_C]/mL 64117-244_aa4d9339-9ea6-48f1-8aa3-a3229322c8cd 64117-244 HUMAN OTC DRUG RUNNY NOSE COUGH JUSTICIA ADHATODA LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply JUSTICIA ADHATODA LEAF 30 [hp_C]/mL 64117-245_8ebad32f-dd2a-43f3-999d-1631ed340ab1 64117-245 HUMAN OTC DRUG HEMORRHOIDS PROCTALGIA POTASSIUM CHLORATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM CHLORATE 30 [hp_C]/mL 64117-246_5d7aab54-e824-475f-9dac-8ab65b3e9728 64117-246 HUMAN OTC DRUG DYSPEPSIA POTASSIUM NITRATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM NITRATE 30 [hp_C]/mL 64117-247_967c0507-428a-4781-9aab-3927d74fc444 64117-247 HUMAN OTC DRUG RUNNY NOSE POTASSIUM SILICATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM SILICATE 30 [hp_C]/mL 64117-248_c507b8ae-3433-4ee1-9c6b-2103d341fe3d 64117-248 HUMAN OTC DRUG INCONTINENCE VOMITING WOOD CREOSOTE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply WOOD CREOSOTE 30 [hp_C]/mL 64117-249_e5d73e00-0622-4956-bd28-7a4d27067a6e 64117-249 HUMAN OTC DRUG HEADACHE CONSTIPATION SKIM MILK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SKIM MILK 30 [hp_C]/mL 64117-250_75e8a2a2-3df0-43e5-b65a-ad5034455dea 64117-250 HUMAN OTC DRUG HEADACHE STIFF NECK LACHNANTHES CAROLINIANA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LACHNANTHES CAROLINIANA 30 [hp_C]/mL 64117-251_8abf8e7d-aa57-4afa-8cc9-fa39bed6969c 64117-251 HUMAN OTC DRUG ITCHING SKIN CALCIUM HEXAFLUOROSILICATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALCIUM HEXAFLUOROSILICATE 30 [hp_C]/mL 64117-252_89c38038-c143-4c09-b73e-872c8d215efe 64117-252 HUMAN OTC DRUG RHEUMATISM ARCTIUM LAPPA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARCTIUM LAPPA ROOT 30 [hp_C]/mL 64117-253_03a2d032-896c-4904-8e78-d731068a40be 64117-253 HUMAN OTC DRUG RHEUMATIC PAINS LATHYRUS SATIVAS SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LATHYRUS SATIVAS SEED 30 [hp_C]/mL 64117-254_c80a6cc8-8ec3-43c5-8e06-d863cf91fb59 64117-254 HUMAN OTC DRUG ASTHMA LEMNA MINOR PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LEMNA MINOR 30 [hp_C]/mL 64117-255_f0a0a685-9a08-4cd0-8ebf-0a82ded85248 64117-255 HUMAN OTC DRUG BILIOUSNESS HEADACHE VERONICASTRUM VIRGINICUM ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VERONICASTRUM VIRGINICUM ROOT 30 [hp_C]/mL 64117-256_9b2b953a-f342-457b-85ff-88af4bfb8de4 64117-256 HUMAN OTC DRUG RHEUMATSM LITHIUM CARBONATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LITHIUM CARBONATE 30 [hp_C]/mL 64117-257_13efc7bd-98a8-4b61-bb3f-ec15cf9104f3 64117-257 HUMAN OTC DRUG COUGH HEADACHE TOMATO PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TOMATO 30 [hp_C]/mL 64117-258_270efe79-57da-4fa8-9608-812a8636bd56 64117-258 HUMAN OTC DRUG COUGH HEADACHE LYCOPUS VIRGINICUS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LYCOPUS VIRGINICUS 30 [hp_C]/mL 64117-259_7caa0e3b-6bd1-4e20-b022-7fcdadd7b1af 64117-259 HUMAN OTC DRUG ITCHY SKIN ERUPTIONS MAGNESIUM SULFATE HEPTAHYDRATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MAGNESIUM SULFATE HEPTAHYDRATE 30 [hp_C]/mL 64117-260_e20e9dd8-0148-4aa7-9227-e6414a26f0ec 64117-260 HUMAN OTC DRUG SKIN ERUPTIONS MANGANESE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MANGANESE 30 [hp_C]/mL 64117-261_4cb04806-e22e-4d88-a8a5-3bd8bab0b653 64117-261 HUMAN OTC DRUG DYSPEPSIA MENTHOL PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MENTHOL 30 [hp_C]/mL 64117-262_62d09d0a-92ee-4533-8422-615c0f82e688 64117-262 HUMAN OTC DRUG SORE THROAT WITH PALLOR CALOMEL PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALOMEL 30 [hp_C]/mL 64117-263_c1996908-9dbf-433d-936e-747518762d11 64117-263 HUMAN OTC DRUG BURNING DIARRHEA MERCURIC SULFATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MERCURIC SULFATE 30 [hp_C]/mL 64117-264_1dc2a993-c0c4-4221-b8d4-482002e63cbd 64117-264 HUMAN OTC DRUG COUGH HICCOUGH MOSCHUS MOSCHIFERUS MUSK SAC RESIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MOSCHUS MOSCHIFERUS MUSK SAC RESIN 30 [hp_C]/mL 64117-265_ad21c39e-3666-493a-a254-eb095caca888 64117-265 HUMAN OTC DRUG HEMMORHOIDS HYDROCHLORIC ACID PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HYDROCHLORIC ACID 30 [hp_C]/mL 64117-266_4e0a05c6-2268-401a-a44a-fb8ee82c3774 64117-266 HUMAN OTC DRUG HEADACHE SORE THROAT MORELLA CERIFERA ROOT BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MORELLA CERIFERA ROOT BARK 30 [hp_C]/mL 64117-267_6f5fbeb8-aa94-494e-9fa4-dd35f9ab4c83 64117-267 HUMAN OTC DRUG HEADACHE DRY COUGH NAJA NAJA VENOM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply NAJA NAJA VENOM 30 [hp_C]/mL 64117-268_44329250-8e63-426f-8662-48ff4d44c0ec 64117-268 HUMAN OTC DRUG RUNNY NOSE SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE 30 [hp_C]/mL 64117-269_4d7cc8d8-e4d2-4e4a-9362-5254efd041a1 64117-269 HUMAN OTC DRUG INFLAMMATIONS SODIUM NITRATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SODIUM NITRATE 30 [hp_C]/mL 64117-270_7d654476-f534-4ca7-b439-267d01dca76d 64117-270 HUMAN OTC DRUG DYSPEPSIA SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 30 [hp_C]/mL 64117-271_116a564c-880d-4130-94b3-79a1145c8bd8 64117-271 HUMAN OTC DRUG HEADACHE NICKEL PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply NICKEL 30 [hp_C]/mL 64117-272_552a73cb-c7ec-4b64-b8ea-9fd6a15e5125 64117-272 HUMAN OTC DRUG BLADDER IRRITATION OCIMUM AMERICANUM LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply OCIMUM AMERICANUM LEAF 30 [hp_C]/mL 64117-273_f22c6ebe-8234-4be2-85e3-6efa0673b190 64117-273 HUMAN OTC DRUG ITCHY SKIN ERRUPTIONS NERIUM OLEANDER LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply NERIUM OLEANDER LEAF 30 [hp_C]/mL 64117-274_d60d3c0a-783c-46ab-8b66-b03e7086ac6a 64117-274 HUMAN OTC DRUG DRY SORE THROAT ONOSMODIUM VIRGINIANUM ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ONOSMODIUM VIRGINIANUM ROOT 30 [hp_C]/mL 64117-275_51f5c91e-8f99-4672-9e86-a8a9b99afe5d 64117-275 HUMAN OTC DRUG HEADACHE PAEONIA OFFICINALIS ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PAEONIA OFFICINALIS ROOT 30 [hp_C]/mL 64117-276_216920b5-caab-4897-93b4-a15ccd782fd4 64117-276 HUMAN OTC DRUG HEMORRHOIDS PETROSELINUM CRISPUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PETROSELINUM CRISPUM 30 [hp_C]/mL 64117-277_7423412b-3393-48b6-933c-b86df10a5fce 64117-277 HUMAN OTC DRUG MUSCLE SORENESS HEADACHE PHYSOSTIGMA VENENOSUM SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PHYSOSTIGMA VENENOSUM SEED 30 [hp_C]/mL 64117-278_7c637c30-d37a-4c77-9769-07bb2055f3cd 64117-278 HUMAN OTC DRUG EARACHE TOOTHACHE PLANTAGO MAJOR PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PLANTAGO MAJOR 30 [hp_C]/mL 64117-279_b202a5ff-1c1b-491c-ab3f-f9a3905c1489 64117-279 HUMAN OTC DRUG HEADACHE FRANGULA CALIFORNICA BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply FRANGULA CALIFORNICA BARK 30 [hp_C]/mL 64117-280_cab3a269-30cf-4941-91f5-51cc329d817c 64117-280 HUMAN OTC DRUG HEADACHE RHODIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply RHODIUM 30 [hp_C]/mL 64117-281_e6da9370-092d-41e3-9a06-25b9c0bdc73c 64117-281 HUMAN OTC DRUG SKIN ERUPTIONS TOXICODENDRON VERNIX LEAFY TWIG PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TOXICODENDRON VERNIX LEAFY TWIG 30 [hp_C]/mL 64117-282_f8825276-16f3-4ab9-9ea1-66cd8ab64b57 64117-282 HUMAN OTC DRUG DYSPEPSIA HEADACHE SUCROSE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SUCROSE 30 [hp_C]/mL 64117-283_34c4a894-cdeb-4bea-9f72-798ad690b92b 64117-283 HUMAN OTC DRUG CONGESTIVE HEADACHE SOLANUM NIGRUM TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SOLANUM NIGRUM TOP 30 [hp_C]/mL 64117-284_01ebf6fc-4753-4102-a8e7-4dc884544d94 64117-284 HUMAN OTC DRUG ITCHY SKIN RASH SOLIDAGO VIRGAUREA FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SOLIDAGO VIRGAUREA FLOWERING TOP 30 [hp_C]/mL 64117-285_0cb8ab53-fdcd-4abe-b4dc-20d136c461ad 64117-285 HUMAN OTC DRUG ITCHY SKIN RASH SYZYGIUM CUMINI SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SYZYGIUM CUMINI SEED 30 [hp_C]/mL 64117-286_33f20512-8b93-4ea0-a459-4b21e2910b5a 64117-286 HUMAN OTC DRUG DYSMENORRHEA FATIGUE TANACETUM VULGARE TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TANACETUM VULGARE TOP 30 [hp_C]/mL 64117-287_9bbd8dd0-c1ac-41e4-97bd-209b6859023b 64117-287 HUMAN OTC DRUG SKIN ERUPTIONS TELLURIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TELLURIUM 30 [hp_C]/mL 64117-288_196a735a-571b-495e-b450-71e71ec1ec22 64117-288 HUMAN OTC DRUG RUNNY NOSE TEUCRIUM MARUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TEUCRIUM MARUM 30 [hp_C]/mL 64117-289_d037889e-f3e6-428d-b291-55aeeb9316b4 64117-289 HUMAN OTC DRUG MUSCLE SPASMS THALLIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply THALLIUM 30 [hp_C]/mL 64117-290_6ab1a037-f60c-4986-a0a9-91447c48ba0a 64117-290 HUMAN OTC DRUG DIARRHEA CAPSELLA BURSA-PASTORIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CAPSELLA BURSA-PASTORIS 30 [hp_C]/mL 64117-291_dd89d931-ace4-4abb-a1ac-abca503eb662 64117-291 HUMAN OTC DRUG NAUSEA TITANIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TITANIUM 30 [hp_C]/mL 64117-292_8bfe3836-52d1-4b24-a078-01883667faea 64117-292 HUMAN OTC DRUG SUDDEN NAUSEA VERATRUM VIRIDE ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VERATRUM VIRIDE ROOT 30 [hp_C]/mL 64117-293_bafb05ce-c405-47f1-91d5-784455d63bfd 64117-293 HUMAN OTC DRUG DRY COUGH VERBASCUM THAPSUS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VERBASCUM THAPSUS 30 [hp_C]/mL 64117-294_5c77bb08-e0fa-4b52-88da-d940e4abd8a8 64117-294 HUMAN OTC DRUG SKIN ERUPTIONS VINCA MINOR PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VINCA MINOR 30 [hp_C]/mL 64117-295_d6feabff-69cc-40d0-82a4-e6a523aec288 64117-295 HUMAN OTC DRUG DRY COUGH HEADACHE VIOLA ODORATA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VIOLA ODORATA 30 [hp_C]/mL 64117-296_9c92f43d-f519-4f59-a6ad-df95cc5aaa7e 64117-296 HUMAN OTC DRUG HEADCHES PAINFUL MENSTRUATION ZANTHOXYLUM AMERICANUM BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ZANTHOXYLUM AMERICANUM BARK 30 [hp_C]/mL 64117-297_a933027a-6267-47ff-b579-d54b227212a3 64117-297 HUMAN OTC DRUG RHEUMATISM GUAIACUM SANCTUM RESIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GUAIACUM SANCTUM RESIN 30 [hp_C]/mL 64117-298_10a7aee6-e302-49f8-a905-7016ceb86e25 64117-298 HUMAN OTC DRUG HEADACHE HELODERMA HORRIDUM VENOM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HELODERMA HORRIDUM VENOM 30 [hp_C]/mL 64117-299_9fce8b66-c876-499c-86de-754308c68f27 64117-299 HUMAN OTC DRUG NAUSEA VESPA CRABRO PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VESPA CRABRO 30 [hp_C]/mL 64117-301_bee637e1-a67c-4373-a615-00398e80f660 64117-301 HUMAN OTC DRUG NHS HEADACHE ADONIS VERNALIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ADONIS VERNALIS 30 [hp_C]/mL 64117-302_5987ddca-4bc1-4bd2-a1ed-164c2466e492 64117-302 HUMAN OTC DRUG COLIC with GAS ALETRIS FARINOSA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ALETRIS FARINOSA ROOT 30 [hp_C]/mL 64117-303_9b6bf940-29c8-4f6a-8f6d-3ff858e024b2 64117-303 HUMAN OTC DRUG HEADACHE AMYL NITRITE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AMYL NITRITE 30 [hp_C]/1 64117-304_f644d963-bc35-457d-baa0-7bd34795058e 64117-304 HUMAN OTC DRUG DRY COUGH ARALIA RACEMOSA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARALIA RACEMOSA ROOT 30 [hp_C]/1 64117-305_d7939359-30c2-4d81-86f7-1c7db18e6c59 64117-305 HUMAN OTC DRUG COLIC DIARRHEA ARANEUS DIADEMATUS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARANEUS DIADEMATUS 30 [hp_C]/1 64117-504_be7e2420-282c-4274-aff2-cd8c1783220c 64117-504 HUMAN OTC DRUG Diarrhea ALOE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ALOE 30 [hp_C]/mL 64117-518_b06e79d6-ab6c-4010-8aea-34d3099dfa8c 64117-518 HUMAN OTC DRUG NHS Dyspepsia Dyspepsia PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_C]/mL 64117-519_98830e82-eaf9-45be-ad57-aeffb4be591f 64117-519 HUMAN OTC DRUG Teething Pain TRIBASIC CALCIUM PHOSPHATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TRIBASIC CALCIUM PHOSPHATE 30 [hp_C]/mL 64117-524_4eb8b7fa-f29a-4adc-a602-175458dc5aef 64117-524 HUMAN OTC DRUG NHS Insomnia 1 Insomnia 1 PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CAULOPHYLLUM THALICTROIDES ROOT 30 [hp_C]/mL 64117-525_bf041952-0cfb-4102-95f7-066b31bed979 64117-525 HUMAN OTC DRUG NHS Hoarse Cough Hoarse Cough PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CAUSTICUM 30 [hp_C]/mL 64117-529_f3ee3259-a503-46c4-a6c6-9cb556767e38 64117-529 HUMAN OTC DRUG NHS Muscle Cramps 1 Muscle Cramps 1 PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BLACK COHOSH 30 [hp_C]/mL 64117-531_b3f73ddc-1a74-4cab-b814-80b79193777d 64117-531 HUMAN OTC DRUG NHS Insomnia 2 Insomnia 2 PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARABICA COFFEE BEAN 30 [hp_C]/mL 64117-534_f5f95dd0-0f87-4742-8f92-931f2d5a8d1f 64117-534 HUMAN OTC DRUG Heartburn CONIUM MACULATUM FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CONIUM MACULATUM FLOWERING TOP 30 [hp_C]/mL 64117-535_78007316-3e78-40ba-8a38-17ca6749509f 64117-535 HUMAN OTC DRUG Fever Vomiting CROTALUS HORRIDUS HORRIDUS VENOM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CROTALUS HORRIDUS HORRIDUS VENOM 30 [hp_C]/mL 64117-543_fcf0d748-4281-4895-886c-55b5ab09459c 64117-543 HUMAN OTC DRUG Headache NITROGLYCERIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply NITROGLYCERIN 30 [hp_C]/mL 64117-545_37f3365e-a60d-411d-8881-71c04c098f45 64117-545 HUMAN OTC DRUG Irritated Cracked Skin GRAPHITE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GRAPHITE 30 [hp_C]/mL 64117-546_d366eca0-3d16-479d-844c-4057af432763 64117-546 HUMAN OTC DRUG Hemorrhoids Bruises HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 30 [hp_C]/mL 64117-548_4ab141cb-57e1-4a87-96a1-e864c4e7cdac 64117-548 HUMAN OTC DRUG Spasmodic Cough HYOSCYAMUS NIGER PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HYOSCYAMUS NIGER 30 [hp_C]/mL 64117-553_cff7af63-71a7-4727-abdc-6267d12bdb19 64117-553 HUMAN OTC DRUG Nausea Vomiting IPECAC PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply IPECAC 30 [hp_C]/mL 64117-556_dbb479cc-a2be-498b-97e2-029b54f64871 64117-556 HUMAN OTC DRUG Sore Throat CANIS LUPUS FAMILIARIS MILK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CANIS LUPUS FAMILIARIS MILK 30 [hp_C]/mL 64117-570_02f1f0e9-f4e2-4195-ba98-cab4c3a8d11d 64117-570 HUMAN OTC DRUG Skin Eruptions DAPHNE MEZEREUM BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply DAPHNE MEZEREUM BARK 30 [hp_C]/mL 64117-577_4a01d4b3-ac4b-4a6d-8d7e-2629225bdb4b 64117-577 HUMAN OTC DRUG Eczema KEROSENE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply KEROSENE 30 [hp_C]/mL 64117-580_2459b8ce-2743-478e-95b1-965ef57f9309 64117-580 HUMAN OTC DRUG Sore Throat Inflammation PHYTOLACCA AMERICANA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PHYTOLACCA AMERICANA ROOT 30 [hp_C]/mL 64117-581_e0892fe8-5105-405b-9999-4aa746a8cb84 64117-581 HUMAN OTC DRUG Constipation Cramps LEAD PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LEAD 30 [hp_C]/mL 64117-585_34ee55f5-1178-4b1a-acb7-408b8335a3bc 64117-585 HUMAN OTC DRUG Eczema RANCID BEEF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply RANCID BEEF 30 [hp_C]/mL 64117-587_4d2ad897-95a9-4fd9-a404-2c205c95e9e1 64117-587 HUMAN OTC DRUG Tickling Cough RUMEX CRISPUS ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply RUMEX CRISPUS ROOT 30 [hp_C]/mL 64117-592_b1b4aa11-e2c1-40ba-b7ed-e46ac38d49dc 64117-592 HUMAN OTC DRUG PMS Irritability SEPIA OFFICINALIS JUICE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SEPIA OFFICINALIS JUICE 30 [hp_C]/mL 64117-595_90bd6538-2664-4f67-b18f-38ed340bc061 64117-595 HUMAN OTC DRUG Skin Eruptions DELPHINIUM STAPHISAGRIA SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply DELPHINIUM STAPHISAGRIA SEED 30 [hp_C]/mL 64117-596_0e60c2c5-8bf7-439b-87af-5a987eac9547 64117-596 HUMAN OTC DRUG Headache DATURA STRAMONIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply DATURA STRAMONIUM 30 [hp_C]/mL 64117-600_52963c2f-c38a-4592-80ac-693406b024b3 64117-600 HUMAN OTC DRUG Warts THUJA OCCIDENTALIS LEAFY TWIG PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply THUJA OCCIDENTALIS LEAFY TWIG 30 [hp_C]/mL 64117-643_8faf9bdf-23b2-4a30-97b3-10c36eb2addb 64117-643 HUMAN OTC DRUG NHS HIP PAIN GARLIC PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GARLIC 30 [hp_C]/mL 64117-705_dcb63a25-9d22-48cd-8b95-9ad84514af4b 64117-705 HUMAN OTC DRUG Hemmorrhoids Hemorrhoids PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HORSE CHESTNUT 30 [hp_C]/mL 64117-709_03d2c9dc-1a07-4b30-b97e-7dc65bba08b0 64117-709 HUMAN OTC DRUG Constipation Constipation PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ALUMINUM OXIDE 30 [hp_C]/mL 64117-714_7f974142-4bbd-4637-92f1-180502712eab 64117-714 HUMAN OTC DRUG Muscle Cramps Muscle Cramps PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SEMECARPUS ANACARDIUM JUICE 30 [hp_C]/mL 64117-718_ac1c892f-288e-4fdc-9bc8-b4d469241ed4 64117-718 HUMAN OTC DRUG NHS Rheumatism Rheumatism PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ANTIMONY TRISULFIDE 30 [hp_C]/mL 64117-722_d130dc54-3c1a-4961-9282-5149fcbc5027 64117-722 HUMAN OTC DRUG CONSTIPATION ARSENIC PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARSENIC 30 [hp_C]/1 64117-733_22112f85-35ed-40cc-ab9a-397a70f7212a 64117-733 HUMAN OTC DRUG Sore Throat BARIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BARIUM CATION 30 [hp_C]/mL 64117-744_5380b237-5618-4ebb-b5b8-f06bcb5073dc 64117-744 HUMAN OTC DRUG NHS Spasms Weakness Spasms Weakness PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SELENICEREUS GRANDIFLORUS STEM 30 [hp_C]/mL 64117-748_b2024c8d-7a18-47b6-b936-0349490818c9 64117-748 HUMAN OTC DRUG Sore Throat CALCIUM FLUORIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALCIUM FLUORIDE 30 [hp_C]/mL 64117-765_9644530c-9477-4489-8b69-d6150b791598 64117-765 HUMAN OTC DRUG Colic Colic PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARTEMISIA CINA FLOWER 30 [hp_C]/mL 64117-791_a734b64e-cb12-4d55-93ba-e97e32ab90d8 64117-791 HUMAN OTC DRUG Biliousness Diarrhea IRON PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply IRON 30 [hp_C]/mL 64117-805_2a8e3da9-47f7-432a-a856-49538a6c8e43 64117-805 HUMAN OTC DRUG Headache Drowsiness HELLEBORUS NIGER ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HELLEBORUS NIGER ROOT 30 [hp_C]/mL 64117-810_183b9d21-2b94-4564-a9ea-1a358ab8073e 64117-810 HUMAN OTC DRUG Colds Yellow Mucous GOLDENSEAL PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GOLDENSEAL 30 [hp_C]/mL 64117-831_da34553d-d917-481e-823c-330deaca270b 64117-831 HUMAN OTC DRUG Eczema Potassium Cation PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM CATION 30 [hp_C]/mL 64117-839_11ed1398-17c7-4561-a5b3-03fbc7300e5e 64117-839 HUMAN OTC DRUG Stomach Cramps 1 LATRODECTUS MACTANS VENOM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LATRODECTUS MACTANS VENOM 30 [hp_C]/mL 64117-842_8e193738-73a1-479a-aca5-3c2d78045001 64117-842 HUMAN OTC DRUG Dysmenorrhea Diarrhea LILIUM LANCIFOLIUM BULB PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LILIUM LANCIFOLIUM BULB 30 [hp_C]/mL 64117-866_d16da8c7-1429-4b71-bbb3-ab1b26539d1a 64117-866 HUMAN OTC DRUG Headache SODIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SODIUM CATION 30 [hp_C]/mL 64117-867_73751c2c-c994-4f03-b340-4161aac8156e 64117-867 HUMAN OTC DRUG Skin Eruptions Sodium Chloride PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SODIUM CHLORIDE 30 [hp_C]/mL 64117-873_cd1f4a4f-9e60-4b5a-ac61-d9d3ef0ef4f2 64117-873 HUMAN OTC DRUG Warts NITRIC ACID PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply NITRIC ACID 30 [hp_C]/mL 64117-888_0e3edf37-f14d-490d-a1a0-8e9069fc365d 64117-888 HUMAN OTC DRUG Neuralgia Numbness PLATINUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PLATINUM 30 [hp_C]/mL 64117-902_9b6a6cb5-a75d-457a-95da-6be54482653e 64117-902 HUMAN OTC DRUG Sore Throat Coughs SANGUINARIA CANADENSIS ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SANGUINARIA CANADENSIS ROOT 30 [hp_C]/mL 64117-912_7d65c994-e65d-4e87-bf12-f69fb6ffc949 64117-912 HUMAN OTC DRUG Skin Eruptions SPIGELIA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SPIGELIA MARILANDICA ROOT 30 [hp_C]/mL 64117-921_c670a185-8d45-4b2c-9b9f-cca65c1628e1 64117-921 HUMAN OTC DRUG Headache Restlessness LYCOSA TARANTULA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LYCOSA TARANTULA 30 [hp_C]/mL 64117-926_addfd90a-0150-445a-b38a-0b9bfea21c33 64117-926 HUMAN OTC DRUG Ringing in Ears ALLYLTHIOUREA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ALLYLTHIOUREA 30 [hp_C]/mL 64117-951_9c251ffc-d99e-4dc4-82a2-f9dcf19a08ad 64117-951 HUMAN OTC DRUG Cold or Allergy Cold or Allergy PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ONION 30 [hp_C]/mL 64117-952_4f9e1a70-40bd-42ab-a1c4-d3c7ad269bad 64117-952 HUMAN OTC DRUG Cough ANTIMONY POTASSIUM TARTRATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ANTIMONY POTASSIUM TARTRATE 30 [hp_C]/mL 64117-953_5a6ab8d2-bf54-4b46-9775-6058136b185d 64117-953 HUMAN OTC DRUG Stings, Bites, Swellings APIS MELLIFERA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply APIS MELLIFERA 30 [hp_C]/mL 64117-954_02f7544e-c744-4491-864f-64fa77315560 64117-954 HUMAN OTC DRUG Heartburn SILVER CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SILVER CATION 30 [hp_C]/mL 64117-955_75fc57a6-df62-4fcc-8805-d7dc7c6a46b7 64117-955 HUMAN OTC DRUG Bruises-Muscle Soreness Bruises-Muscle Soreness PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARNICA MONTANA 30 [hp_C]/mL 64117-956_45d61919-3078-4d52-8d25-c35331968fc0 64117-956 HUMAN OTC DRUG NHS Flu Nausea Flu Nausea PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARSENIC TRIOXIDE 30 [hp_C]/mL 64117-957_5325f041-1121-45f7-8814-3f0ea002229d 64117-957 HUMAN OTC DRUG NHS Insomnia Insomnia PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GOLD 30 [hp_C]/mL 64117-958_8e23bdc1-190d-477d-9089-f9b6f9935c3e 64117-958 HUMAN OTC DRUG Cramps Spasms COPPER PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply COPPER 30 [hp_C]/mL 64117-959_bb143094-af52-4473-b80c-fac0d1a01ec3 64117-959 HUMAN OTC DRUG Fever Inflammations ATROPA BELLADONNA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ATROPA BELLADONNA 30 [hp_C]/mL 64117-960_1d30fbd5-61e1-41af-8093-4cc30e257df6 64117-960 HUMAN OTC DRUG Sprains Bruises BELLIS PERENNIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BELLIS PERENNIS 30 [hp_C]/mL 64117-961_f323c343-1058-455d-b18f-e10a835ffcc4 64117-961 HUMAN OTC DRUG NHS Headache Flu Headache Flu PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BRYONIA ALBA ROOT 30 [hp_C]/mL 64117-962_1740fdad-6d1e-4d74-a129-97caab28f76d 64117-962 HUMAN OTC DRUG NHS Skin Irritation Cuts Skin Irritation Cuts PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALENDULA OFFICINALIS FLOWERING TOP 30 [hp_C]/mL 64117-963_58d4c25b-c7a9-4051-9117-7a1eb6a37b25 64117-963 HUMAN OTC DRUG Bladder Irritation LYTTA VESICATORIA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LYTTA VESICATORIA 30 [hp_C]/mL 64117-964_a548ce7b-28f7-4c9b-9306-d535f556b740 64117-964 HUMAN OTC DRUG NHS Nausea Heartburn Nausea Heartburn PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ACTIVATED CHARCOAL 30 [hp_C]/mL 64117-965_80821941-1e98-4632-9427-9fe380279a9c 64117-965 HUMAN OTC DRUG Teething Irritability MATRICARIA RECUTITA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MATRICARIA RECUTITA 30 [hp_C]/mL 64117-966_985255e8-d469-4d1f-81d5-d52edea46f99 64117-966 HUMAN OTC DRUG Motion Sickness ANAMIRTA COCCULUS SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ANAMIRTA COCCULUS SEED 30 [hp_C]/mL 64117-967_f7609485-b6c1-4b6a-b8ad-4d0f9cb38934 64117-967 HUMAN OTC DRUG Abdominal Cramps CITRULLUS COLOCYNTHIS FRUIT PULP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CITRULLUS COLOCYNTHIS FRUIT PULP 30 [hp_C]/mL 64117-968_bdf9233d-6bf7-4ae1-aff2-3fd17463533a 64117-968 HUMAN OTC DRUG NHS Flu Fever Sudden Onset BAPTISIA TINCTORIA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BAPTISIA TINCTORIA ROOT 30 [hp_C]/mL 64117-969_f611d801-1f50-449a-af53-5ca96d3ef818 64117-969 HUMAN OTC DRUG Spasmodic Cough DROSERA ROTUNDIFOLIA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply DROSERA ROTUNDIFOLIA 30 [hp_C]/mL 64117-970_04e8a61f-afa0-457b-bf47-07b840224a59 64117-970 HUMAN OTC DRUG Eye Irritation EUPHRASIA STRICTA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply EUPHRASIA STRICTA 30 [hp_C]/mL 64117-971_a828c2ed-7a11-4bf3-86f1-e999240d31a4 64117-971 HUMAN OTC DRUG Fever Inflammations FERRUM PHOSPHORICUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply FERRUM PHOSPHORICUM 30 [hp_C]/mL 64117-972_79576a76-80cb-4902-b96d-70dc7a43bbd6 64117-972 HUMAN OTC DRUG Flu Headache GELSEMIUM SEMPERVIRENS ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GELSEMIUM SEMPERVIRENS ROOT 30 [hp_C]/mL 64117-973_525015c7-4900-4414-b850-2a89711947b8 64117-973 HUMAN OTC DRUG Cough Runny Nose CALCIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALCIUM CATION 30 [hp_C]/mL 64117-974_eaa1c609-a51e-4115-9c74-f622576886ab 64117-974 HUMAN OTC DRUG Nerve Pain HYPERICUM PERFORATUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HYPERICUM PERFORATUM 30 [hp_C]/mL 64117-975_c6949594-40dc-4f80-a6aa-20284d83439e 64117-975 HUMAN OTC DRUG Shock Grief STRYCHNOS IGNATII SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply STRYCHNOS IGNATII SEED 30 [hp_C]/mL 64117-977_c8ab7fdc-0c4a-48b2-a9b6-545bb3d85a39 64117-977 HUMAN OTC DRUG Nasel congestion Potassium Cation PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM CATION 30 [hp_C]/mL 64117-978_14277f5c-ea57-4ba6-9cc3-caefccb90408 64117-978 HUMAN OTC DRUG Sore Throat LACHESIS MUTA VENOM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LACHESIS MUTA VENOM 30 [hp_C]/mL 64117-979_e4669169-9139-494e-8f08-cdb394434614 64117-979 HUMAN OTC DRUG Puncture Wounds Bites LEDUM PALUSTRE TWIG PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LEDUM PALUSTRE TWIG 30 [hp_C]/mL 64117-980_4763c084-3869-4de3-a6c3-51d52f3ff5f0 64117-980 HUMAN OTC DRUG Upset Stomach, Constipation LYCOPODIUM CLAVATUM SPORE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LYCOPODIUM CLAVATUM SPORE 30 [hp_C]/mL 64117-981_ef8f7909-fb5b-4244-9e56-2a4116f5b88d 64117-981 HUMAN OTC DRUG Sore Throat MERCURY PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MERCURY 30 [hp_C]/mL 64117-982_de5023a3-65be-4028-b221-f78d37d196d4 64117-982 HUMAN OTC DRUG Chills and Fevers Sodium Cation PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SODIUM CATION 30 [hp_C]/mL 64117-983_c0e23458-1a47-4739-ab73-fd7105d8ffaa 64117-983 HUMAN OTC DRUG Nausea Constipation STRYCHNOS NUX-VOMICA SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/mL 64117-984_9dfcfb18-2dca-42f3-81cb-80cee175c768 64117-984 HUMAN OTC DRUG Cough Sore Throat PHOSPHORUS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PHOSPHORUS 30 [hp_C]/mL 64117-985_4ebfdc20-fb7d-4934-bae6-d9c0b9f3f79b 64117-985 HUMAN OTC DRUG Headache PHOSPHORIC ACID PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PHOSPHORIC ACID 30 [hp_C]/mL 64117-986_389a119b-dc6d-44e1-a152-7bdd5480b0a5 64117-986 HUMAN OTC DRUG Colds Earache PULSATILLA VULGARIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PULSATILLA VULGARIS 30 [hp_C]/mL 64117-987_c8d8a305-df5f-4c95-850a-4e3b774e77b0 64117-987 HUMAN OTC DRUG Arthritis Pain TOXICODENDRON PUBESCENS LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TOXICODENDRON PUBESCENS LEAF 30 [hp_C]/mL 64117-988_0506683a-6af9-4bf8-a355-929c0e6c4aad 64117-988 HUMAN OTC DRUG Sprains, Tendonitis RUTA GRAVEOLENS FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply RUTA GRAVEOLENS FLOWERING TOP 30 [hp_C]/mL 64117-989_3620dbbd-73d6-439e-b09c-b17c08e88a58 64117-989 HUMAN OTC DRUG Skin Eruptions SILICON DIOXIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SILICON DIOXIDE 30 [hp_C]/mL 64117-990_198b3da6-0d49-43bb-9e64-a76cc7bbf8a5 64117-990 HUMAN OTC DRUG Dry Cough SPONGIA OFFICINALIS SKELETON, ROASTED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SPONGIA OFFICINALIS SKELETON, ROASTED 30 [hp_C]/mL 64117-991_8bd15866-7eaf-4a26-b5b4-3fd5665b8d03 64117-991 HUMAN OTC DRUG Skin Rashes Eczema SULFUR PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SULFUR 30 [hp_C]/mL 64117-992_c7e10744-bdcb-4f1c-9051-5079a8005fed 64117-992 HUMAN OTC DRUG Bone Injuries COMFREY ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply COMFREY ROOT 30 [hp_C]/mL 64117-993_641e655a-91cd-4ac2-aa8b-68d9ec7c0854 64117-993 HUMAN OTC DRUG Motion Sickness 1 TOBACCO LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TOBACCO LEAF 30 [hp_C]/mL 64117-994_5948b106-f9fa-4cdd-a390-8fb0621542ff 64117-994 HUMAN OTC DRUG Burns Itchy Skin URTICA URENS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply URTICA URENS 30 [hp_C]/mL 64117-995_39d63b53-8eb8-42e5-ad74-fcce11c910f0 64117-995 HUMAN OTC DRUG Diarrhea Vomiting VERATRUM ALBUM ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VERATRUM ALBUM ROOT 30 [hp_C]/mL 64117-996_0cba7165-3282-42c7-81be-f37fffea6e40 64117-996 HUMAN OTC DRUG Stomach Cramps AMANITA MUSCARIA VAR. MUSCARIA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AMANITA MUSCARIA VAR. MUSCARIA 30 [hp_C]/mL 64117-997_015fd2f3-417c-460a-be1f-952963720638 64117-997 HUMAN OTC DRUG NHS Flatulance Slow Digestion Flatulance Slow Digestion PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CINCHONA OFFICINALIS BARK 30 [hp_C]/mL 64117-998_d1dfb7a9-67e3-4cf2-bf77-a5e9790cdead 64117-998 HUMAN OTC DRUG Menstrual Muscle Cramps MAGNESIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MAGNESIUM CATION 30 [hp_C]/mL 64117-999_b6441e97-0c96-46a4-8eb9-b88bf18927e2 64117-999 HUMAN OTC DRUG NHS Rheumatism Eczema Rheumatism Eczema PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BERBERIS VULGARIS ROOT BARK 30 [hp_C]/mL 64121-056_7cf2c895-73ad-498d-a7ef-40d2fae7ca20 64121-056 HUMAN OTC DRUG KE-53PS Gel Hand Sanitizer KE-53PS Gel Hand Sanitizer SOLUTION TOPICAL 20131105 OTC MONOGRAPH NOT FINAL part333A Kinzua Environmental, Inc. ALCOHOL 62 mL/100mL 64121-515_24b35ee1-549e-4a6c-94f0-2c9a5651a404 64121-515 HUMAN OTC DRUG KE-53PS Hand Sanitizer ethanol GEL TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Kinzua Environmental Inc. ETHANOL 600 mL/1000mL 64122-604_2947cbf0-c86e-4a08-a4b2-1f59b1b4a0c9 64122-604 HUMAN OTC DRUG AfterPill Levonorgestrel TABLET ORAL 20130215 ANDA ANDA202508 Syzygy Healthcare Solutions, LLC LEVONORGESTREL 1.5 mg/1 64125-116_cd25b50f-e1c5-4ed0-a370-e3b8a7b77f01 64125-116 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Excellium Pharmaceutical Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 64125-117_cd25b50f-e1c5-4ed0-a370-e3b8a7b77f01 64125-117 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Excellium Pharmaceutical Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 64125-118_cd25b50f-e1c5-4ed0-a370-e3b8a7b77f01 64125-118 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Excellium Pharmaceutical Inc. FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 64125-127_9e9d2d70-0925-4d05-88d1-13b1de4bfc56 64125-127 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20090601 ANDA ANDA040796 Excellium Pharmaceutical Inc. FOLIC ACID 1 mg/1 64125-130_85594a90-366d-4d66-8d80-218dffef94d8 64125-130 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070601 ANDA ANDA040702 Excellium Pharmaceutical Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 64125-131_85594a90-366d-4d66-8d80-218dffef94d8 64125-131 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070601 ANDA ANDA040702 Excellium Pharmaceutical Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 64125-133_9a23d0f8-191b-4a68-b25a-627e22571373 64125-133 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20121101 ANDA ANDA040903 Excellium Pharmaceutical, Inc IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 64125-134_9a23d0f8-191b-4a68-b25a-627e22571373 64125-134 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20121101 ANDA ANDA040903 Excellium Pharmaceutical, Inc IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 64125-135_9a23d0f8-191b-4a68-b25a-627e22571373 64125-135 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20121101 ANDA ANDA040903 Excellium Pharmaceutical, Inc IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 64125-136_819347a9-acae-47b6-bf37-72054d2a2269 64125-136 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20121201 ANDA ANDA090168 Excellium Pharmaceutical, Inc, BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 64125-137_819347a9-acae-47b6-bf37-72054d2a2269 64125-137 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20121201 ANDA ANDA090168 Excellium Pharmaceutical, Inc, BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 64125-138_819347a9-acae-47b6-bf37-72054d2a2269 64125-138 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20121201 ANDA ANDA090168 Excellium Pharmaceutical, Inc, BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 64125-139_a4aaf034-13f3-45f1-ba76-e6e34ab290c7 64125-139 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20121001 ANDA ANDA090195 Excellium Pharmaceutical, Inc. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 64125-140_a4aaf034-13f3-45f1-ba76-e6e34ab290c7 64125-140 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20121001 ANDA ANDA090195 Excellium Pharmaceutical, Inc. GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 64125-904_ab3860a3-70b7-40a0-9f32-573c666b59b2 64125-904 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Excellium Pharmaceutical Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 64125-905_ab3860a3-70b7-40a0-9f32-573c666b59b2 64125-905 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Excellium Pharmaceutical Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 64125-906_ab3860a3-70b7-40a0-9f32-573c666b59b2 64125-906 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Excellium Pharmaceutical Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 64126-1234_14db220f-7a28-4235-bd90-04ee0fc17a97 64126-1234 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980317 UNAPPROVED MEDICAL GAS Freedom Medical OXYGEN 99 L/100L 64127-054_86862095-2c59-46fd-8d00-7c3ea4855bf7 64127-054 HUMAN OTC DRUG GM Collin Mineral Sun Veil Tinted Zinc oxide CREAM TOPICAL 20110105 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik Inc ZINC OXIDE .125 mL/mL 64127-074_4f8dc002-d7f7-4543-b83e-3a33df5de535 64127-074 HUMAN OTC DRUG GM Collin Mineral Sun Zinc oxide and titanium dioxide LOTION TOPICAL 20110420 OTC MONOGRAPH NOT FINAL part352 Laboratoires Dermo Cosmetik Inc. TITANIUM DIOXIDE; ZINC OXIDE .08; .039 mL/mL; mL/mL 64127-075_e830aa93-cc54-4a1c-80c6-3353f1f7b549 64127-075 HUMAN OTC DRUG G.M. Collin Acne Salicylic Acid KIT 20091201 OTC MONOGRAPH FINAL part333 Laboratoires Dermo Cosmetik Inc 64127-084_567ff01c-685e-4eca-9617-3c188967d28b 64127-084 HUMAN OTC DRUG G.M. Collin Mineral Sun Veil zinc oxide CREAM TOPICAL 20100517 OTC MONOGRAPH FINAL part352 Laboratoires Dermo Cosmetik Inc. ZINC OXIDE .125 mL/mL 64127-085_4c38c2c5-1915-4adc-9281-591e20bbb753 64127-085 HUMAN OTC DRUG G.M. Collin Complex Acne salicylic acid OIL TOPICAL 20110225 OTC MONOGRAPH FINAL part333D Laboratoires Dermo Cosmetik Inc. SALICYLIC ACID .01 mL/mL 64127-114_8a0a6ea6-7d0d-4524-9af6-0f1b427ece5d 64127-114 HUMAN OTC DRUG GM Collin MINERAL BB titanium dioxide and zinc oxide CREAM TOPICAL 20140214 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik Inc TITANIUM DIOXIDE; ZINC OXIDE 8.5; 4.2 mg/100mL; mg/100mL 64127-134_3d692071-b45c-44b8-bf53-99de505b036d 64127-134 HUMAN OTC DRUG GMC Medical Sun Protection zinc oxide and octinoxate CREAM TOPICAL 20140210 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik Inc OCTINOXATE; ZINC OXIDE 8.3; 11.6 mg/100mL; mg/100mL 64127-135_310e034a-f3ac-430d-86ba-b3f40d819ffb 64127-135 HUMAN OTC DRUG GMC Medical Acne-Clear salicylic acid GEL TOPICAL 20140210 OTC MONOGRAPH FINAL part333D Laboratoires dermo Cosmetik Inc SALICYLIC ACID 21.2 mg/100mL 64127-144_708a8b0c-0daa-45e5-b0d2-0c61200e1839 64127-144 HUMAN OTC DRUG GMC Medical ANTI-AGING TREATMENT zinc oxide and octinoxate KIT 20140210 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik Inc 64127-145_ce1fec03-59a9-4a18-81c4-1edef3a44f64 64127-145 HUMAN OTC DRUG GMC Medical Acne-BPO benzoyl peroxide GEL TOPICAL 20140210 OTC MONOGRAPH FINAL part333D Laboratoires dermo Cosmetik Inc BENZOYL PEROXIDE 51.9 mg/100mL 64127-154_0e323027-fb5a-4545-9973-cd57dcf5f9cf 64127-154 HUMAN OTC DRUG GMC Medical ANTIOXIDANT AND ANTI-AGING TREATMENT zinc oxide and octinoxate KIT 20140210 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik Inc 64127-155_4e90e385-f3f6-49f6-9a65-6a6d4efd8811 64127-155 HUMAN OTC DRUG GMC Medical Acne Treatment salicylic acid and benzoyl peroxide KIT 20140210 OTC MONOGRAPH FINAL part333D Laboratoires dermo Cosmetik Inc 64127-164_5eabfaac-317a-4303-9d58-4ed4796dfab4 64127-164 HUMAN OTC DRUG GMC Medical POST PROCEDURE TREATMENT zinc oxide and octinoxate KIT 20140210 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik Inc 64127-174_c9a20ee6-78f8-4a61-9b48-95f37ddcf8dd 64127-174 HUMAN OTC DRUG GMC Medical zinc oxide and octinoxate KIT 20140210 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik Inc 64140-101_93d93c55-55a2-49a0-8ce9-d267ac70b80d 64140-101 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19910101 UNAPPROVED MEDICAL GAS Greene Respiratory Services, Inc OXYGEN 99 L/100L 64141-001_844617a2-98df-4d36-875c-59b0269541e4 64141-001 HUMAN OTC DRUG BOBBI BROWN SKIN FOUNDATION SPF 15 OCTINOXATE 7.5, TITANIUM DIOXIDE 1.0% LIQUID TOPICAL 20080601 OTC MONOGRAPH NOT FINAL part352 BOBBI BROWN PROFESSIONAL COSMETICS INC OCTINOXATE; TITANIUM DIOXIDE 7.5; 1 mL/100mL; mL/100mL 64141-002_f3165fe7-eab9-4b7c-957a-de5d45176b81 64141-002 HUMAN OTC DRUG NATURAL FINISH LONG LASTING FOUNDATION SPF 15 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20071001 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE 7.5; 1 mL/100mL; mL/100mL 64141-003_d115cd2a-4994-463b-8fe5-cb0887fee26a 64141-003 HUMAN OTC DRUG BRIGHTENING SPOT TREATMENT CORRECTOR SPF 25 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20090301 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc OCTINOXATE; TITANIUM DIOXIDE 7; .98 mL/100mL; mL/100mL 64141-004_14f94091-c417-4a69-b622-ef9aa412e9e4 64141-004 HUMAN OTC DRUG TREATMENT LIPSHINE SPF 15 OCTINOXATE LIPSTICK TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 BOBBI BROWN PROFESSIONAL COSMETICS INC OCTINOXATE 7 g/100g 64141-005_7230b432-469b-4af9-9f1f-86c98297ae76 64141-005 HUMAN OTC DRUG BOBBI BROWN BRIGHTENING PROTECTIVE FACE BASE UV SPF 50 HOMOSALATE, OCTISALATE, AVOBENZONE, OXYBENZONE CREAM TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 5; 5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL 64141-007_6947ca16-f4d3-4aa9-88a4-b0927505b260 64141-007 HUMAN OTC DRUG ILLUMINATING FINISH COMPACT FOUNDATION SPF 12 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE 3; 6.3 g/100g; g/100g 64141-008_611eae2d-9be0-4216-896e-d95b64f4e3ab 64141-008 HUMAN OTC DRUG EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25 OCTINOXATE, HOMOSALATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYBENZONE 2; 5; 7.5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 64141-009_dcdbafc6-92ef-4ca4-b0a3-3c5a1ae49080 64141-009 HUMAN OTC DRUG RICH LIP COLOR SPF 12 OCTINOXATE, OCTISALATE LIPSTICK TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; OCTISALATE 5; 2.5 g/100g; g/100g 64141-010_230a68b1-8c53-4478-88f4-ef3e3479fb43 64141-010 HUMAN OTC DRUG TINTED MOISTURIZER OIL FREE SPF 15 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE 3.5; 1.8 mL/100mL; mL/100mL 64141-011_b935941d-7a9a-4e20-8b22-52a4f98f3bba 64141-011 HUMAN OTC DRUG LONG-WEAR EVEN FINISH FOUNDATION BROAD SPECTRUM SPF 15 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE 2.9; 1.6 mL/100mL; mL/100mL 64141-012_9c7226a9-725e-4907-b05e-6d5569fa99d8 64141-012 HUMAN OTC DRUG BOBBI BROWN BB BROAD SPECTRUM SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 4; 2.5; 1.1 mL/100mL; mL/100mL; mL/100mL; mL/100mL 64141-013_e58a54fa-f3cb-484a-837c-315c3332488d 64141-013 HUMAN OTC DRUG BOBBI BROWN SKIN FOUNDATION BROAD SPECTRUM SPF 15 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE .078; .0104 g/mL; g/mL 64141-014_39df78bd-6a66-4496-a13a-6d25596e466f 64141-014 HUMAN OTC DRUG BOBBI BROWN SPF 50 PROTECTIVE FACE BASE BROAD SPECTRUM AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE LOTION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .29124; .04854; .04854; .0262116; .029124 g/mL; g/mL; g/mL; g/mL; g/mL 64141-015_9f9bf265-cc34-4afe-b3cb-cdacff62f029 64141-015 HUMAN OTC DRUG BOBBI BROWN EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25 OCTINOXATE, HOMOSALATE, OXYBENZONE, and AVOBENZONE CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYBENZONE .0219; .0548; .0821; .0548 g/mL; g/mL; g/mL; g/mL 64141-018_476f4a17-6015-40e4-9f6a-0df02f5b0fe9 64141-018 HUMAN OTC DRUG Bobbi Brown CC BROAD SPECTRUM SPF 25 OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE .08175; .0436; .02725; .01199; .03597 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 64141-019_8782de6f-56eb-4d8a-8958-3c9a675bd3b2 64141-019 HUMAN OTC DRUG BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 AVOBENZONE, OCTINOXATE, and OCTISALATE LIPSTICK TOPICAL 20020201 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 3.5 g/100g; g/100g; g/100g 64141-021_c0f985c7-8585-4e5a-ae24-ff976ccc6d71 64141-021 HUMAN OTC DRUG INTENSIVE SKIN SERUM FOUNDATION BROAD SPECTRUM SPF 40 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .043875; .068625; .04275 g/100mL; g/100mL; g/100mL 64141-111_3bf0b661-620d-4115-89cd-eb55fe852e2a 64141-111 HUMAN OTC DRUG SKIN FOUNDATION MINERAL MAKEUP SPF 15 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE 3.6; 7.8 g/100g; g/100g 64141-112_9a0492aa-8a22-4f7c-a501-d08440de8185 64141-112 HUMAN OTC DRUG EXTRA REPAIR MOISTURING BALM SPF 25 OCTINOXATE, HOMOSALATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20110816 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYBENZONE 2; 5; 7.5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL 64141-113_6c5c6a34-6fa2-479f-a741-feaa060a82f7 64141-113 HUMAN OTC DRUG BOBBIE BROWN CORRECTIVE SPOT TREATMENT BROAD SPECTRUM SPF 25 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120410 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE 98; 15.4 mg/mL; mg/mL 64141-704_fbd26a47-6b65-414c-bc89-762f8b57a454 64141-704 HUMAN OTC DRUG MOISTURE RICH FOUNDATION SPF 15 OCTINOXATE LIPSTICK TOPICAL 20001001 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE 2.2 mL/100mL 64141-718_e64f5ee1-520b-466b-8252-09ab4d0a059d 64141-718 HUMAN OTC DRUG BRIGHTENING POWDER COMPACT FOUNDATION SPF 20 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 18.6; 5.8 g/100g; g/100g; g/100g 64141-743_36f8b37b-41d6-4ddc-8b45-d472e7d80853 64141-743 HUMAN OTC DRUG TINTED MOISTURIZER SPF 15 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE 7.5; 3 mL/100mL; mL/100mL 64141-814_21fb384b-d29b-40f3-ab0c-64e00562983e 64141-814 HUMAN OTC DRUG BOBBI BROWN EXTRA TINTED MOISTURIZING BALM SPF 25 OCTINOXATE, HOMOSALATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYBENZONE 2; 5; 7.5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 64141-866_74e12521-1dc3-4b40-b760-0951d38a9a37 64141-866 HUMAN OTC DRUG BOBBI BROWN PROTECTIVE FACE SPF 15 OCTINOXATE, TITANIUM DIOXIDE LOTION TOPICAL 20100706 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE 7.5; 1.2 mL/100mL; mL/100mL 64141-916_059d1056-8ed8-45e2-9a4a-9397eba1dd5e 64141-916 HUMAN OTC DRUG BOBBI BROWN EXTRA SPF 25 MOISTURIZING BALM HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20001001 OTC MONOGRAPH NOT FINAL part352 BOBBI BROWN PROFESSIONAL COSMETICS INC AVOBENZONE; HOMOSALATE; OCTINOXATE; OXYBENZONE 2; 10; 7.5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 64159-6010_ab1db27c-00ae-42f2-93c5-00dc42fb671d 64159-6010 HUMAN OTC DRUG SENSAI FLUID FINISH LASTING VELVET FV205 SPF 15 TITANIUM DIOXIDE and OCTINOXATE LIQUID TOPICAL 20110801 20150730 OTC MONOGRAPH NOT FINAL part352 KANEBO COSMETICS INC OCTINOXATE; TITANIUM DIOXIDE 4; 4.4 g/100mL; g/100mL 64159-6208_d120365e-09a7-4e0a-8cb6-f5137da3808c 64159-6208 HUMAN OTC DRUG SENSAI CELLULAR PERFORMANCE INTENSIVE HAND TREATMENT OCTINOXATE GEL TOPICAL 20070701 20150205 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC OCTINOXATE 3 g/100mL 64159-6326_650e65f6-417a-4635-9ab5-0a319812abe0 64159-6326 HUMAN OTC DRUG SENSAI SILK 10 SECONDS AWAKENING ESSENCE ENSULIZOLE GEL TOPICAL 20060201 20150501 OTC MONOGRAPH NOT FINAL part352 KANEBO COSMETICS INC ENSULIZOLE 3 g/100mL 64159-6342_ed5fc75d-4a62-4d25-b01b-6806ea59b9b8 64159-6342 HUMAN OTC DRUG SENSAI CELLULAR PERFORMANCE FOUNDATION CF11 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20060801 20150220 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC. OCTINOXATE; TITANIUM DIOXIDE 3; 5 g/100mL; g/100mL 64159-6343_aea6b519-e06c-4cf3-8de2-4e7fa847d178 64159-6343 HUMAN OTC DRUG SENSAI CELLULAR PERFORMANCE FOUNDATION CF12 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20060801 20150318 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC. OCTINOXATE; TITANIUM DIOXIDE 3; 5 g/100mL; g/100mL 64159-6344_182d56da-5f7a-4a9b-ad0b-e5a9c423ecda 64159-6344 HUMAN OTC DRUG SENSAI CELLULAR PERFORMANCE FOUNDATION CF13 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20060801 20150318 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC. OCTINOXATE; TITANIUM DIOXIDE 3; 5 g/100mL; g/100mL 64159-6345_7e05e8bc-3bd7-4dc5-b195-6105686096aa 64159-6345 HUMAN OTC DRUG SENSAI CELLULAR PERFORMANCE FOUNDATION CF14 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20060801 20150422 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC. OCTINOXATE; TITANIUM DIOXIDE 3; 5 g/100mL; g/100mL 64159-6346_126ed8c1-c897-4d1b-9d9e-48b450522622 64159-6346 HUMAN OTC DRUG SENSAI CELLULAR PERFORMANCE CF22 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20060801 20150318 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC. OCTINOXATE; TITANIUM DIOXIDE 3; 5 g/100mL; g/100mL 64159-6347_00e538c9-5930-4f47-bb21-1ea78a9c6b60 64159-6347 HUMAN OTC DRUG SENSAI CELLULAR PERFORMANCE FOUNDATION CF23 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20060801 20150726 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC. OCTINOXATE; TITANIUM DIOXIDE 3; 5 g/100mL; g/100mL 64159-6348_8ad665cd-ee1d-4aa2-8edc-69adcff9828c 64159-6348 HUMAN OTC DRUG SENSAI CELLULAR PERFORMANCE FOUNDATION CF24 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20060801 20150422 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC. OCTINOXATE; TITANIUM DIOXIDE 3; 5 g/100mL; g/100mL 64159-6349_763d4710-9773-40dd-8e5e-194719512271 64159-6349 HUMAN OTC DRUG SENSAI CELLULAR PERFORMANCE FOUNDATION CF25 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20060801 20150422 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC. OCTINOXATE; TITANIUM DIOXIDE 3; 5 g/100mL; g/100mL 64159-6374_98735a1f-dcbe-408a-8cc5-095ab386767e 64159-6374 HUMAN OTC DRUG SENSAI SILKY BRONZE SUN FOR FACE SPF30 OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20070201 20150330 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC. OCTINOXATE; ZINC OXIDE 7.5; 9.8 g/100mL; g/100mL 64159-6376_650c681d-2570-441f-9470-653b22d4ab4a 64159-6376 HUMAN OTC DRUG SENSAI SILKY BRONZE SUN FOR BODY SPF20 AVOBENZONE and OCTINOXATE EMULSION TOPICAL 20141017 20150330 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC. AVOBENZONE; OCTINOXATE 1.2; 4.8 g/100mL; g/100mL 64159-6394_dfaaea67-8c1a-4813-bb40-b7b19d8c58a7 64159-6394 HUMAN OTC DRUG SENSAI SILK BRIGHTENING OCTINOXATE CREAM TOPICAL 20080101 20150618 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC. OCTINOXATE 4 g/100mL 64159-6969_17c54e94-0725-4f7f-8230-b65983bc47a6 64159-6969 HUMAN OTC DRUG SENSAI FLUID FINISH FF102 TITANIUM DIOXIDE and OCTINOXATE LIQUID TOPICAL 20080801 20150401 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC OCTINOXATE; TITANIUM DIOXIDE 3; 4.5 g/100mL; g/100mL 64159-6970_17c54e94-0725-4f7f-8230-b65983bc47a6 64159-6970 HUMAN OTC DRUG SENSAI FLUID FINISH FF103 TITANIUM DIOXIDE and OCTINOXATE LIQUID TOPICAL 20080801 20150402 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC OCTINOXATE; TITANIUM DIOXIDE 3; 4.5 g/100mL; g/100mL 64159-6971_17c54e94-0725-4f7f-8230-b65983bc47a6 64159-6971 HUMAN OTC DRUG SENSAI FLUID FINISH FF202 TITANIUM DIOXIDE and OCTINOXATE LIQUID TOPICAL 20080801 20151225 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC OCTINOXATE; TITANIUM DIOXIDE 3; 4.5 g/100mL; g/100mL 64159-6972_17c54e94-0725-4f7f-8230-b65983bc47a6 64159-6972 HUMAN OTC DRUG SENSAI FLUID FINISH FF203 TITANIUM DIOXIDE and OCTINOXATE LIQUID TOPICAL 20080801 20150514 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC OCTINOXATE; TITANIUM DIOXIDE 3; 4.5 g/100mL; g/100mL 64159-6973_17c54e94-0725-4f7f-8230-b65983bc47a6 64159-6973 HUMAN OTC DRUG SENSAI FLUID FINISH FF204 TITANIUM DIOXIDE and OCTINOXATE LIQUID TOPICAL 20080801 20150307 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC OCTINOXATE; TITANIUM DIOXIDE 3; 4.5 g/100mL; g/100mL 64159-6974_17c54e94-0725-4f7f-8230-b65983bc47a6 64159-6974 HUMAN OTC DRUG SENSAI FLUID FINISH FF204.5 TITANIUM DIOXIDE and OCTINOXATE LIQUID TOPICAL 20080801 20150604 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC OCTINOXATE; TITANIUM DIOXIDE 3; 4.5 g/100mL; g/100mL 64159-6975_17c54e94-0725-4f7f-8230-b65983bc47a6 64159-6975 HUMAN OTC DRUG SENSAI FLUID FINISH FF205 TITANIUM DIOXIDE and OCTINOXATE LIQUID TOPICAL 20080801 20150629 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC OCTINOXATE; TITANIUM DIOXIDE 3; 4.5 g/100mL; g/100mL 64159-6976_17c54e94-0725-4f7f-8230-b65983bc47a6 64159-6976 HUMAN OTC DRUG SENSAI FLUID FINISH FF206 TITANIUM DIOXIDE and OCTINOXATE LIQUID TOPICAL 20080801 20150403 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC OCTINOXATE; TITANIUM DIOXIDE 3; 4.5 g/100mL; g/100mL 64159-6977_e77f2b29-0555-439a-a26f-4b874ea3b2fa 64159-6977 HUMAN OTC DRUG SENSAI CONCEALER (BRUSH TYPE) CB01 TITANIUM DIOXIDE LIQUID TOPICAL 20100801 20150613 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC TITANIUM DIOXIDE 13 g/100mL 64159-6978_e77f2b29-0555-439a-a26f-4b874ea3b2fa 64159-6978 HUMAN OTC DRUG SENSAI CONCEALER (BRUSH TYPE) CB02 TITANIUM DIOXIDE LIQUID TOPICAL 20100801 20150613 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC TITANIUM DIOXIDE 13 g/100mL 64159-6979_e77f2b29-0555-439a-a26f-4b874ea3b2fa 64159-6979 HUMAN OTC DRUG SENSAI CONCEALER (BRUSH TYPE) CB03 TITANIUM DIOXIDE LIQUID TOPICAL 20100801 20150613 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC TITANIUM DIOXIDE 13 g/100mL 64159-6988_e5843fea-a9ac-4da6-975a-30be1d67b213 64159-6988 HUMAN OTC DRUG SENSAI CELLULAR PERFORMANCE FOUNDATION TF11 TITANIUM DIOXIDE POWDER TOPICAL 20080101 20150626 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC TITANIUM DIOXIDE 12.9 g/100g 64159-6991_e5843fea-a9ac-4da6-975a-30be1d67b213 64159-6991 HUMAN OTC DRUG SENSAI CELLULAR PERFORMANCE FOUNDATION TF14 TITANIUM DIOXIDE POWDER TOPICAL 20080101 20150626 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC TITANIUM DIOXIDE 12.9 g/100g 64159-6995_e5843fea-a9ac-4da6-975a-30be1d67b213 64159-6995 HUMAN OTC DRUG SENSAI CELLULAR PERFORMANCE FOUNDATION TF25 TITANIUM DIOXIDE POWDER TOPICAL 20080101 20150730 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC TITANIUM DIOXIDE 12.9 g/100g 64159-7046_8a3c1685-4986-4493-98b8-ee8c8d7acbf0 64159-7046 HUMAN OTC DRUG SENSAI BG61 OCTINOXATE and TITANIUM DIOXIDE GEL TOPICAL 20100201 20150605 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC. OCTINOXATE; TITANIUM DIOXIDE 3.5; .89 g/100mL; g/100mL 64159-7047_64cf5b3f-e8af-41a7-be59-7681599e0766 64159-7047 HUMAN OTC DRUG SENSAI BG62 OCTINOXATE and TITANIUM DIOXIDE GEL TOPICAL 20100201 20150628 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC. OCTINOXATE; TITANIUM DIOXIDE 3.5; .89 g/100mL; g/100mL 64159-7048_424cd86b-b49e-4d31-9358-c0f5830e6084 64159-7048 HUMAN OTC DRUG SENSAI BG63 OCTINOXATE and TITANIUM DIOXIDE GEL TOPICAL 20100201 20150514 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC. OCTINOXATE; TITANIUM DIOXIDE 3.5; .89 g/100mL; g/100mL 64159-7088_cc3bd58e-e1d4-4214-ab4b-33693e065f1f 64159-7088 HUMAN OTC DRUG SENSAI TRIPLE TOUCH COMPACT TC02 TITANIUM DIOXIDE, ZINC OXIDE and OCTINOXATE KIT 20100301 20150830 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC. 64159-7089_7ef044c0-e9b1-4829-b99d-178068fd75ed 64159-7089 HUMAN OTC DRUG SENSAI TRIPLE TOUCH COMPACT TC03 TITANIUM DIOXIDE, ZINC OXIDE and OCTINOXATE KIT 20100301 20150830 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC. 64159-7180_eb1ed098-b29e-4cab-9d42-7c3ec6d7c0a5 64159-7180 HUMAN OTC DRUG SENSAI CELLULAR PERFORMANCE WRINKLE REPAIR COLLAGENERGY SPF20 AVOBENZONE and OCTINOXATE CREAM TOPICAL 20110115 20150215 OTC MONOGRAPH FINAL part352 KANEBO COSMETICS INC AVOBENZONE; OCTINOXATE 1.2; 4.8 g/100mL; g/100mL 64159-7698_ab1db27c-00ae-42f2-93c5-00dc42fb671d 64159-7698 HUMAN OTC DRUG SENSAI FLUID FINISH LASTING VELVET FV203 SPF 15 TITANIUM DIOXIDE and OCTINOXATE LIQUID TOPICAL 20110801 20150403 OTC MONOGRAPH NOT FINAL part352 KANEBO COSMETICS INC OCTINOXATE; TITANIUM DIOXIDE 4; 4.4 g/100mL; g/100mL 64159-7699_ab1db27c-00ae-42f2-93c5-00dc42fb671d 64159-7699 HUMAN OTC DRUG SENSAI FLUID FINISH LASTING VELVET FV204 SPF 15 TITANIUM DIOXIDE and OCTINOXATE LIQUID TOPICAL 20110801 20150403 OTC MONOGRAPH NOT FINAL part352 KANEBO COSMETICS INC OCTINOXATE; TITANIUM DIOXIDE 4; 4.4 g/100mL; g/100mL 64159-7700_ab1db27c-00ae-42f2-93c5-00dc42fb671d 64159-7700 HUMAN OTC DRUG SENSAI FLUID FINISH LASTING VELVET FV204.5 SPF 15 TITANIUM DIOXIDE and OCTINOXATE LIQUID TOPICAL 20110801 20150403 OTC MONOGRAPH NOT FINAL part352 KANEBO COSMETICS INC OCTINOXATE; TITANIUM DIOXIDE 4; 4.4 g/100mL; g/100mL 64159-7701_5ab8af49-7fa9-4b5d-abf7-321ca4265d44 64159-7701 HUMAN OTC DRUG SENSAI LIP BASE SPF15 AVOBENZONE and OCTINOXATE LIPSTICK TOPICAL 20081001 20150617 OTC MONOGRAPH FINAL part352 Kanebo Cosmetics Inc. AVOBENZONE; OCTINOXATE .6; 2.4 g/100g; g/100g 64169-001_79621cf9-c628-46fc-a03a-5fed8f32a239 64169-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19971001 NDA NDA205767 Industrial Source OXYGEN 990 mL/L 64169-002_59753954-5dbb-4fbb-80be-bd79cf85ba5f 64169-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20140101 NDA NDA205766 Industrial Source NITROGEN 995 mL/L 64175-525_ad79d607-d040-4867-8334-3b8f9d71872f 64175-525 HUMAN OTC DRUG Menopause HF Cimicifuga racemosa, Trifolium pratense, Magnesia carbonica, Agnus castus TABLET ORAL 20100801 UNAPPROVED HOMEOPATHIC Foster Regal Laboratories BLACK COHOSH; CHASTE TREE; MAGNESIUM CARBONATE; RED CLOVER 1; 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 64175-991_1a40b1b6-7852-421a-9557-50174b01a995 64175-991 HUMAN OTC DRUG Relax AM-PM Valerian Root, Passiflora, Magnesium Carbonate TABLET ORAL 20120207 UNAPPROVED HOMEOPATHIC Foster Regal Laboratories MAGNESIUM CARBONATE; PASSIFLORA INCARNATA FLOWER; VALERIAN 1; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 64191-515_bc667117-7df3-4a1c-b5c2-630aac65bf40 64191-515 HUMAN OTC DRUG chempace SANI-GEL INSTANT SKIN SANITIZER ethanol GEL TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Chempace Corporation ETHANOL 600 mL/1000mL 64193-223_3bdffc8e-b908-4827-b941-31a1f7063125 64193-223 PLASMA DERIVATIVE FEIBA NF Anti-Inhibitor Coagulant Complex KIT 19860131 BLA BLA101447 Baxter Healthcare Corporation 64193-224_3bdffc8e-b908-4827-b941-31a1f7063125 64193-224 PLASMA DERIVATIVE FEIBA NF Anti-Inhibitor Coagulant Complex KIT 19860131 BLA BLA101447 Baxter Healthcare Corporation 64193-225_3bdffc8e-b908-4827-b941-31a1f7063125 64193-225 PLASMA DERIVATIVE FEIBA NF Anti-Inhibitor Coagulant Complex KIT 19860131 BLA BLA101447 Baxter Healthcare Corporation 64193-244_527b44a6-f9e2-4eae-8f68-6b4134465196 64193-244 HUMAN PRESCRIPTION DRUG Bebulin VH COAGULATION FACTOR IX HUMAN KIT 20110316 BLA BLA103112 Baxter Healthcare Corporation 64193-423_752604e5-4ea2-44f4-83ed-1569373f6412 64193-423 HUMAN PRESCRIPTION DRUG FEIBA NF Anti-Inhibitor Coagulant Complex KIT 20110701 BLA BLA101447 Baxter Healthcare Corporation 64193-424_752604e5-4ea2-44f4-83ed-1569373f6412 64193-424 HUMAN PRESCRIPTION DRUG FEIBA NF Anti-Inhibitor Coagulant Complex KIT 20110701 BLA BLA101447 Baxter Healthcare Corporation 64193-425_752604e5-4ea2-44f4-83ed-1569373f6412 64193-425 HUMAN PRESCRIPTION DRUG FEIBA NF Anti-Inhibitor Coagulant Complex KIT 20110701 BLA BLA101447 Baxter Healthcare Corporation 64193-445_bc12b9b9-c06d-447f-b08e-77907c357bfd 64193-445 PLASMA DERIVATIVE BEBULIN COAGULATION FACTOR IX HUMAN KIT 19920819 BLA BLA103112 Baxter Healthcare Corporation 64201-001_0969cc00-d57f-6079-e054-00144ff8d46c 64201-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19930601 UNAPPROVED MEDICAL GAS Nix's Medical Supply, Inc. OXYGEN .99 L/L 64203-020_c27976db-4405-4141-9fb9-1db6a2b16cab 64203-020 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19930101 UNAPPROVED MEDICAL GAS Schryver Medical Sales and Marketing, Inc. OXYGEN 99 L/100L 64205-005_5b19c0fc-71dc-4898-8ea8-ca31ccb2b9f8 64205-005 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 ReadyMeds SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 64205-006_5b19c0fc-71dc-4898-8ea8-ca31ccb2b9f8 64205-006 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 ReadyMeds SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 64205-032_df1f9d8d-4945-4d63-9ec3-43f47ed66bf5 64205-032 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 ReadyMeds WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 64205-048_c89ccdc3-9d35-4d46-93f0-4de254b99040 64205-048 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 ReadyMeds ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 64205-077_f127fece-11a0-457d-8653-763d471ff347 64205-077 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 ReadyMeds MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 64205-078_0217e704-e3f3-4c71-aa01-106adb9ff9c8 64205-078 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 ANDA ANDA074052 ReadyMeds ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 64205-087_f127fece-11a0-457d-8653-763d471ff347 64205-087 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 ReadyMeds MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 64205-101_d1008381-21e1-4097-bb77-df25a38145e9 64205-101 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120112 ANDA ANDA062713 ReadyMeds CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 64205-102_d1008381-21e1-4097-bb77-df25a38145e9 64205-102 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120112 ANDA ANDA062713 ReadyMeds CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 64205-104_4689d485-ecc3-4c14-ba94-2eb84459ca0a 64205-104 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120112 ANDA ANDA062058 ReadyMeds AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 64205-106_8669fa89-72e1-4ac8-97b4-50a5ca630321 64205-106 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20120828 ANDA ANDA077923 ReadyMeds MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 64205-108_8669fa89-72e1-4ac8-97b4-50a5ca630321 64205-108 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20120828 ANDA ANDA077923 ReadyMeds MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 64205-113_4ff3a93c-7273-4ad2-9e79-27c6e2542449 64205-113 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20130516 ANDA ANDA074761 ReadyMeds KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 64205-126_c52473b6-90bb-4cdf-bd43-595b27ec6ab0 64205-126 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100630 ANDA ANDA077918 ReadyMeds MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 64205-127_c52473b6-90bb-4cdf-bd43-595b27ec6ab0 64205-127 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100630 ANDA ANDA077918 ReadyMeds MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 64205-130_e643d63b-1847-4c87-a17c-dfefac867cf3 64205-130 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20100315 ANDA ANDA090510 ReadyMeds HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 64205-157_be99b97c-5eae-4b31-8da8-b557d8f6abd0 64205-157 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20100723 ANDA ANDA091004 ReadyMeds ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 64205-161_a16f882c-6e69-4551-ae58-9d53f4a16da0 64205-161 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 ReadyMeds MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 64205-181_9750dad0-252f-4a2f-8f03-e3c20f62c88c 64205-181 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 ReadyMeds PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 64205-193_0d970762-e0c3-4093-9a82-75feb39b68df 64205-193 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 ReadyMeds FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64205-207_1b3a8591-6566-4561-93da-6d3d5db1c4b5 64205-207 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 ReadyMeds CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64205-210_ff7e2f5f-f8da-427f-852d-a2f36e027171 64205-210 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 ReadyMeds LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 64205-211_e5944f68-5757-4cd6-ab12-d3388446e5ae 64205-211 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 ReadyMeds LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 64205-212_e5944f68-5757-4cd6-ab12-d3388446e5ae 64205-212 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 ReadyMeds LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 64205-214_ff7e2f5f-f8da-427f-852d-a2f36e027171 64205-214 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 ReadyMeds LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 64205-218_a2bb21a0-5548-426e-9fcb-1d1db9897041 64205-218 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 ReadyMeds METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 64205-219_a4e7a41f-c95d-4726-9e57-0cf382ce4ddb 64205-219 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin TABLET, FILM COATED ORAL 19780710 NDA NDA050754 ReadyMeds AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 64205-220_b701df7c-4e31-4228-ab81-87d8c13bc54a 64205-220 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 ReadyMeds METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 64205-222_978f94ad-3db9-4985-bd67-60e7e8cfe3ec 64205-222 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 ReadyMeds GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64205-224_a4e7a41f-c95d-4726-9e57-0cf382ce4ddb 64205-224 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin TABLET, FILM COATED ORAL 19780710 NDA NDA050754 ReadyMeds AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 64205-225_2a3f0ee4-9ddc-41b0-ade9-465f61ce0ebd 64205-225 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20120104 ANDA ANDA090428 ReadyMeds LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 64205-226_2a3f0ee4-9ddc-41b0-ade9-465f61ce0ebd 64205-226 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20120104 ANDA ANDA090428 ReadyMeds LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 64205-252_db9f5e35-c19b-40b0-a215-6899eb067ce5 64205-252 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110822 ANDA ANDA070044 ReadyMeds METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 64205-272_04e14584-43e8-454d-a93c-a2f0b083c207 64205-272 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 ReadyMeds SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 64205-333_25d4e3b9-cc3e-4525-a08d-fab3cbdb7b6e 64205-333 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070027 ReadyMeds METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 64205-357_2701e00c-2d9c-4845-852e-76d10bc4e4b4 64205-357 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA090540 ReadyMeds CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 64205-488_c89ccdc3-9d35-4d46-93f0-4de254b99040 64205-488 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 ReadyMeds ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 64205-506_0217e704-e3f3-4c71-aa01-106adb9ff9c8 64205-506 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073025 ReadyMeds ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 64205-520_a54651f7-ec26-4eff-8a65-c1b89cc42f28 64205-520 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER ReadyMeds PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 64205-521_8e16fbac-73fd-4c5c-8a65-3f991d10fafd 64205-521 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 ReadyMeds PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 64205-536_11fbcc9d-c5fe-4062-a68e-9833776fc4c4 64205-536 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 ReadyMeds BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 64205-537_9e1db57a-4e0c-4f46-bd0e-698124854b59 64205-537 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 ReadyMeds LEVOFLOXACIN 500 mg/1 64205-541_d7a25b18-8774-42b7-afff-cf78a0f05274 64205-541 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100218 ANDA ANDA078218 ReadyMeds CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 64205-585_9c5798fc-0e62-4967-888c-4db58c9ab86c 64205-585 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 ReadyMeds ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64205-620_e917d45b-e5fd-4ef1-943c-eea347952386 64205-620 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20080725 ANDA ANDA075347 ReadyMeds OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 64205-627_f249793c-3a32-4163-8e17-b3a7f098f37c 64205-627 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 ReadyMeds TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 64205-640_e917d45b-e5fd-4ef1-943c-eea347952386 64205-640 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20080725 ANDA ANDA075347 ReadyMeds OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 64205-655_07f02165-c20c-47bb-aba1-481feb397058 64205-655 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA091576 ReadyMeds MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 64205-739_83abfca3-49a0-4f31-a4e4-ca3882f0021c 64205-739 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 ReadyMeds FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 64205-740_83abfca3-49a0-4f31-a4e4-ca3882f0021c 64205-740 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 ReadyMeds FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 64205-745_8e16fbac-73fd-4c5c-8a65-3f991d10fafd 64205-745 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 ReadyMeds PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 64205-820_ab70a357-eb3a-4018-b7c7-a0a6627f4356 64205-820 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19801105 ANDA ANDA087059 ReadyMeds HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 64205-821_ab70a357-eb3a-4018-b7c7-a0a6627f4356 64205-821 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19801105 ANDA ANDA087068 ReadyMeds HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 64205-927_74bf41a6-b284-42fd-a08a-4fc8d7213c7d 64205-927 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 ReadyMeds CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 64205-928_74bf41a6-b284-42fd-a08a-4fc8d7213c7d 64205-928 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 ReadyMeds CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 64205-965_52b33a33-da21-4d86-aa55-393db4046b28 64205-965 HUMAN PRESCRIPTION DRUG Sertraline sertraline hydrochloride TABLET, FILM COATED ORAL 20121106 ANDA ANDA077864 ReadyMeds SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64208-8234_8ca52b52-533e-47e0-b42c-fafd45b87463 64208-8234 PLASMA DERIVATIVE Gammaplex HUMAN IMMUNOGLOBULIN G SOLUTION INTRAVENOUS 20101101 BLA BLA125329 Bio Products Laboratory Limited HUMAN IMMUNOGLOBULIN G 5 g/100mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 64220-420_db5b7681-1e06-4ff2-a0c1-5304b298f0f0 64220-420 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20110810 ANDA ANDA078110 Zhejiang Huahai Pharmaceutical Co., Ltd. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64220-421_db5b7681-1e06-4ff2-a0c1-5304b298f0f0 64220-421 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20110810 ANDA ANDA078110 Zhejiang Huahai Pharmaceutical Co., Ltd. ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64220-422_db5b7681-1e06-4ff2-a0c1-5304b298f0f0 64220-422 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20110810 ANDA ANDA078110 Zhejiang Huahai Pharmaceutical Co., Ltd. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64220-423_db5b7681-1e06-4ff2-a0c1-5304b298f0f0 64220-423 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20110810 ANDA ANDA078110 Zhejiang Huahai Pharmaceutical Co., Ltd. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64220-424_db5b7681-1e06-4ff2-a0c1-5304b298f0f0 64220-424 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20110810 ANDA ANDA078110 Zhejiang Huahai Pharmaceutical Co., Ltd. ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64220-425_db5b7681-1e06-4ff2-a0c1-5304b298f0f0 64220-425 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20110810 ANDA ANDA078110 Zhejiang Huahai Pharmaceutical Co., Ltd. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64220-426_db5b7681-1e06-4ff2-a0c1-5304b298f0f0 64220-426 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20110810 ANDA ANDA078110 Zhejiang Huahai Pharmaceutical Co., Ltd. ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64227-515_ba6051f3-f537-4c1b-8f3a-cda943180584 64227-515 HUMAN OTC DRUG Enbac skin antiseptic/sanitizer contains aloe vera HUSKY 515 GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 Correlated Products Inc. ALCOHOL 600 mL/1000mL 64233-515_871d0179-5626-4be3-a84e-5384a906f186 64233-515 HUMAN OTC DRUG ALCO-SAN INSTANT SKIN SANITIZER ALCOHOL GEL TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Mid-American Chemical Research Corporation ALCOHOL 600 mL/1000mL 64235-515_ae1c4970-11f5-4d9a-b531-7c9d2f7b9f5f 64235-515 HUMAN OTC DRUG IHS 2000 INSTANT HAND SANITIZER ethanol GEL TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Ruth Industries , Inc. ETHANOL 600 mL/1000mL 64238-515_bdd20f31-e6ee-4c0c-b981-ad22b03cc9e7 64238-515 HUMAN OTC DRUG 3P Instant Hand Sanitizer ethanol GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 3-P Specialty Inc. ETHANOL 600 mL/1000mL 64239-101_039c3f5e-7a16-404b-8869-5ef75769d964 64239-101 HUMAN PRESCRIPTION DRUG PerioChip Chlorhexidine Gluconate INSERT, EXTENDED RELEASE PERIODONTAL 19980501 NDA NDA020774 Dexcel Pharma Technologies Ltd. CHLORHEXIDINE GLUCONATE 2.5 mg/1 Decreased Cell Wall Integrity [PE] 64239-303_4573fceb-4260-48f9-a8dd-b29684fddbb0 64239-303 HUMAN OTC DRUG Omeprazole Delayed Release Omeprazole TABLET, DELAYED RELEASE ORAL 20080301 NDA NDA022032 Dexcel Pharma Technologies Ltd. OMEPRAZOLE 20 mg/1 64246-0001_f9266aec-3214-4c17-bc29-dc476da48ade 64246-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20010426 UNAPPROVED MEDICAL GAS Foothill Oxygen Service, Inc. OXYGEN 99 L/100L 64249-0001_1cff68cf-ba2a-4396-9094-3345c4a60040 64249-0001 HUMAN OTC DRUG Babyteeth not applicable LIQUID ORAL 20140818 UNAPPROVED HOMEOPATHIC VitaMed, LLC ACONITUM NAPELLUS; ATROPA BELLADONNA; DELPHINIUM STAPHISAGRIA SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; NITRIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SODIUM BORATE; TRIBASIC CALCIUM PHOSPHATE 30; 30; 9; 8; 3; 30; 6; 30; 8 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 64249-0002_5c370f63-7d6e-4448-bd57-7f89b1803ba2 64249-0002 HUMAN OTC DRUG Hemvento not applicable SPRAY ORAL 20140818 UNAPPROVED HOMEOPATHIC VitaMed, LLC ARNICA MONTANA; CALCIUM FLUORIDE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROCHLORIC ACID; KRAMERIA LAPPACEA ROOT; MILK THISTLE 3; 9; 3; 1; 1; 6; 3; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64249-0003_3d16d777-06ce-44c5-aa77-640e5112447d 64249-0003 HUMAN PRESCRIPTION DRUG Esmenopa not applicable SPRAY ORAL 20140818 UNAPPROVED HOMEOPATHIC VitaMed, LLC AMERICAN GINSENG; ANGELICA SINENSIS ROOT; APIS MELLIFERA; ARNICA MONTANA; BLACK COHOSH; CHASTE TREE; GALIUM APARINE; GLYCYRRHIZA GLABRA; SEPIA OFFICINALIS JUICE; SUS SCROFA OVARY; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP 3; 3; 6; 6; 3; 3; 3; 3; 30; 30; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 64249-0004_6143efb9-2c73-4bac-bd23-54fa4a3ed421 64249-0004 HUMAN PRESCRIPTION DRUG MOMLOVE not applicable SPRAY ORAL 20140818 UNAPPROVED HOMEOPATHIC VitaMed, LLC ANGUILLA ROSTRATA BLOOD SERUM; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; GINGER; MILK THISTLE; PODOPHYLLUM; SYMPHORICARPOS ALBUS FRUIT 30; 6; 6; 6; 3; 6; 200 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 64249-0005_5be2cf65-a6fd-4118-a522-26ec849d17fd 64249-0005 HUMAN OTC DRUG ZIZISNO not applicable SPRAY ORAL 20140818 UNAPPROVED HOMEOPATHIC VitaMed, LLC ACTIVATED CHARCOAL; ANTIMONY POTASSIUM TARTRATE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; LOBARIA PULMONARIA; MERCURIC CHLORIDE; SUS SCROFA LUNG; TEUCRIUM MARUM 12; 200; 3; 200; 200; 6; 3 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 64253-202_d1468c0f-dd4f-4d38-a84c-c1d110303965 64253-202 HUMAN PRESCRIPTION DRUG sodium chloride sodium chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20120113 NDA NDA202832 Medefil, Inc. SODIUM CHLORIDE 9 mg/mL 64257-515_40e43bae-98eb-4283-9dad-3c1d8d47696f 64257-515 HUMAN OTC DRUG Chemco Anisha K. Instant Skin Sanitizer HUSKY 515 GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 CHEMCO INDUSTRIES, INC. ALCOHOL 600 mL/1000mL 64268-001_d996baf4-d301-4192-9ee7-523ec51b056c 64268-001 HUMAN OTC DRUG TOMMY GIRL ANTIPERSPIRANT DEODORANT ALUMINUM ZIRCONIUM TETRACHLORHYDREX GLY STICK TOPICAL 20010701 OTC MONOGRAPH FINAL part350 TOMMY HILFIGER TOILETRIES ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.4 g/100g 64268-694_00574dfc-a7c1-4c99-881e-03a7cb24d83a 64268-694 HUMAN OTC DRUG TOMMY HILFIGER ANTIPERSPIRANT DEODORANT ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20010101 OTC MONOGRAPH FINAL part350 TOMMY HILFIGER TOILETRIES ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.6 g/100g 64269-9902_ad6d99fb-9b13-47d5-b0ed-b2312b2b1274 64269-9902 HUMAN OTC DRUG Scarlight MD HYDROQUINONE LIQUID TOPICAL 20021101 OTC MONOGRAPH NOT FINAL part358 Scarguard Labs, LLC HYDROQUINONE 20 mg/mL 64269-9903_617c546b-3088-405c-bc14-d1759573976e 64269-9903 HUMAN OTC DRUG Scarguard MD Hydrocortisone Silicone LIQUID TOPICAL 20011101 OTC MONOGRAPH NOT FINAL part348 Scarguard Labs, LLC HYDROCORTISONE; PHENYL TRIMETHICONE 5; 12 mg/mL; mL/100mL 64269-9907_68f62ea7-c771-4f97-905b-9545a64ab142 64269-9907 HUMAN OTC DRUG Solarguard MD Homosalate Oxybenzone Octocrylene Octisalate Avobenzone SPRAY TOPICAL 20090401 OTC MONOGRAPH FINAL part352 Scarguard Labs, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 5; 6 g/100mL; mL/100mL; mL/100mL; mL/100mL; g/100mL 64269-9909_a2810ad7-8a93-4d1e-9f31-2770f411c24e 64269-9909 HUMAN OTC DRUG Scarguard MD Physicians Formula Hydrocortisone Silicone LIQUID TOPICAL 20011001 OTC MONOGRAPH NOT FINAL part348 Scarguard Labs, LLC HYDROCORTISONE; PHENYL TRIMETHICONE 5.5; 12.75 mg/mL; mL/100mL 64269-9910_2a0ec669-297e-4a20-87cf-3a6d59f38a31 64269-9910 HUMAN OTC DRUG Bruiseguard MD ARNICA MONTANA KIT 20090301 UNAPPROVED HOMEOPATHIC Scarguard Labs, LLC 64272-736_44e0c3f7-e014-4c2f-94b0-741f2e0588cb 64272-736 HUMAN OTC DRUG AFRICAN SEA-COCONUT Herbal Mixture Elm SYRUP ORAL 20120601 OTC MONOGRAPH NOT FINAL part356 LUEN FOOK MEDICINE SDN. BHD. ELM 65 mg/5mL 64281-100_c548caab-cc91-49c9-bb21-62ab23a30e76 64281-100 HUMAN PRESCRIPTION DRUG Provocholine methacholine chloride POWDER, FOR SOLUTION RESPIRATORY (INHALATION) 20130327 NDA NDA019193 Methapharm Inc. METHACHOLINE CHLORIDE 100 mg/100mg Cholinergic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 64305-001_2e11175d-b83d-4a07-83c2-a7f99438edb7 64305-001 HUMAN OTC DRUG symmetry Hand Sanitizer with Aloe and Vitamin E ETHYL ALCOHOL LIQUID TOPICAL 20140522 OTC MONOGRAPH NOT FINAL part333E Project, Inc. ALCOHOL 620 mg/mL 64305-003_84dc37f6-c469-43fa-9e96-50b8882f69cc 64305-003 HUMAN OTC DRUG symmetry Foaming Hand Sanitizer with Aloe and Vitamin E ETHYL ALCOHOL LIQUID TOPICAL 20140522 OTC MONOGRAPH NOT FINAL part333E Project, Inc. ALCOHOL 620 mg/mL 64305-006_c0ff6b33-abaf-4d4a-a14c-e50b9756c81d 64305-006 HUMAN OTC DRUG symmetry Antimicrobial Foaming Hand Wash CHLOROXYLENOL LIQUID TOPICAL 20140523 OTC MONOGRAPH NOT FINAL part333E Project, Inc. CHLOROXYLENOL 3 mg/mL 64305-007_fe62f826-4b87-4046-9cf6-9057603329c7 64305-007 HUMAN OTC DRUG symmetry Non-Alcohol Foaming Hand Sanitizer with Allantoin and Aloe BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140523 OTC MONOGRAPH NOT FINAL part333E Project, Inc. BENZALKONIUM CHLORIDE 1.2 mg/mL 64305-009_16217c55-d6b3-4fd0-ae73-e5a1031873a3 64305-009 HUMAN OTC DRUG symmetry Foaming Hand Sanitizer Fragrance Free with Aloe and Vitamin E ETHYL ALCOHOL LIQUID TOPICAL 20140523 OTC MONOGRAPH NOT FINAL part333E Project, Inc. ALCOHOL 620 mg/mL 64307-001_6e697a2a-488f-499e-afee-1b7c64a00207 64307-001 HUMAN OTC DRUG Decon Hand Instant Hand Sanitizer Alcohol LIQUID TOPICAL 19990601 OTC MONOGRAPH NOT FINAL part333E Veltek Associates, Inc. ALCOHOL 64.5 mL/100mL 64370-375_0e1f0a71-92fd-4d45-825e-9244d66722cc 64370-375 HUMAN PRESCRIPTION DRUG HEMANGEOL propranolol hydrochloride SOLUTION ORAL 20140414 NDA NDA205410 Pierre Fabre Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 4.28 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 64370-532_3f002c72-3343-4707-a2a6-7ae87aa336b0 64370-532 HUMAN PRESCRIPTION DRUG NAVELBINE Vinorelbine tartrate INJECTION INTRAVENOUS 20051115 NDA NDA020388 Pierre Fabre Pharmaceuticals, Inc. VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 64376-128_c324479d-0ca7-4353-8c43-5c628734e14c 64376-128 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine CAPSULE ORAL 20120817 ANDA ANDA078349 Boca Pharmacal, LLC ZIDOVUDINE 100 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 64376-129_c7065c5f-38d6-438c-862b-cb4d3519975a 64376-129 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine SOLUTION ORAL 20120817 ANDA ANDA077981 Boca Pharmacal, LLC ZIDOVUDINE 50 mg/5mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 64376-130_52d05097-1d59-4a99-a5e3-a8b40ac0ed48 64376-130 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120817 ANDA ANDA076890 Boca Pharmacal, LLC LEVOFLOXACIN 250 mg/1 64376-131_52d05097-1d59-4a99-a5e3-a8b40ac0ed48 64376-131 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120817 ANDA ANDA076890 Boca Pharmacal, LLC LEVOFLOXACIN 500 mg/1 64376-132_52d05097-1d59-4a99-a5e3-a8b40ac0ed48 64376-132 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120817 ANDA ANDA076890 Boca Pharmacal, LLC LEVOFLOXACIN 750 mg/1 64376-133_a1ac2cfb-8d6f-4a81-91b0-9239bf4ebf1c 64376-133 HUMAN PRESCRIPTION DRUG Stavudine Stavudine SOLUTION ORAL 20120817 ANDA ANDA078030 Boca Pharmacal, LLC STAVUDINE 1 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 64376-136_07135bcc-356a-4c7a-9660-969989723907 64376-136 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20140912 ANDA ANDA077319 Boca Pharmacal, LLC LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64376-136_e14aad40-52d4-4810-857e-d649e104bba5 64376-136 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110926 ANDA ANDA077319 Boca Pharmacal, LLC LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64376-137_07135bcc-356a-4c7a-9660-969989723907 64376-137 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20140912 ANDA ANDA077319 Boca Pharmacal, LLC LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64376-137_e14aad40-52d4-4810-857e-d649e104bba5 64376-137 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110926 ANDA ANDA077319 Boca Pharmacal, LLC LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64376-138_07135bcc-356a-4c7a-9660-969989723907 64376-138 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20140912 ANDA ANDA077319 Boca Pharmacal, LLC LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64376-138_e14aad40-52d4-4810-857e-d649e104bba5 64376-138 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110929 ANDA ANDA077319 Boca Pharmacal, LLC LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64376-438_eebb3171-3e16-4798-b055-ae6d9e39d593 64376-438 HUMAN PRESCRIPTION DRUG ANTIPYRINE AND BENZOCAINE ANTIPYRINE AND BENZOCAINE SOLUTION AURICULAR (OTIC) 20090430 UNAPPROVED DRUG OTHER Boca Pharmacal, LLC ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 64376-507_020c50ae-30dd-4e24-b16e-e73310a28326 64376-507 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20120116 UNAPPROVED DRUG OTHER Boca Pharmacal, Inc. SALSALATE 500 mg/1 64376-508_020c50ae-30dd-4e24-b16e-e73310a28326 64376-508 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20120116 UNAPPROVED DRUG OTHER Boca Pharmacal, Inc. SALSALATE 750 mg/1 64376-603_fff0728f-286a-4ef2-b920-dbbe9ea1385c 64376-603 HUMAN PRESCRIPTION DRUG Methscopolamine Bromide Methscopolamine Bromide TABLET ORAL 20061228 ANDA ANDA040624 Boca Pharmacal, LLC METHSCOPOLAMINE BROMIDE 2.5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 64376-604_fff0728f-286a-4ef2-b920-dbbe9ea1385c 64376-604 HUMAN PRESCRIPTION DRUG Methscopolamine Bromide Methscopolamine Bromide TABLET ORAL 20061228 ANDA ANDA040624 Boca Pharmacal, LLC METHSCOPOLAMINE BROMIDE 5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 64376-605_db8a715c-560c-4c71-bb1d-af5eaac4ed01 64376-605 HUMAN PRESCRIPTION DRUG Carbinoxamine Maleate Carbinoxamine Maleate TABLET ORAL 20080530 ANDA ANDA040639 Boca Pharmacal, LLC CARBINOXAMINE MALEATE 4 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 64376-612_db8a715c-560c-4c71-bb1d-af5eaac4ed01 64376-612 HUMAN PRESCRIPTION DRUG Carbinoxamine Maleate Carbinoxamine Maleate SOLUTION ORAL 20080226 ANDA ANDA040814 Boca Pharmacal, LLC CARBINOXAMINE MALEATE 4 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 64376-630_cba2aca4-0ed7-41d9-b274-36282a18d855 64376-630 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20101015 ANDA ANDA090248 Boca Pharmacal, LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64376-631_cba2aca4-0ed7-41d9-b274-36282a18d855 64376-631 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20101015 ANDA ANDA090248 Boca Pharmacal, LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64376-632_cba2aca4-0ed7-41d9-b274-36282a18d855 64376-632 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20101015 ANDA ANDA090248 Boca Pharmacal, LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64376-633_cba2aca4-0ed7-41d9-b274-36282a18d855 64376-633 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20101015 ANDA ANDA090248 Boca Pharmacal, LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64376-640_ee479cae-7378-4cfc-ab06-6f91a3a2e620 64376-640 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate, Acetaminophen SOLUTION ORAL 20110727 ANDA ANDA040894 Boca Pharmacal, LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII 64376-643_199c76c6-5246-4be5-932d-d87467f8c14a 64376-643 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20110114 ANDA ANDA090415 Boca Pharmacal, LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 64376-648_199c76c6-5246-4be5-932d-d87467f8c14a 64376-648 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20110114 ANDA ANDA090415 Boca Pharmacal, LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 64376-649_199c76c6-5246-4be5-932d-d87467f8c14a 64376-649 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20110114 ANDA ANDA090415 Boca Pharmacal, LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 64376-650_b2f154cc-ff8b-4a07-800c-997c18b125d1 64376-650 HUMAN PRESCRIPTION DRUG Benzphetamine Hydrochloride Benzphetamine Hydrochloride TABLET ORAL 20100907 ANDA ANDA040747 Boca Pharmacal, LLC BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 64376-655_c3ba2f6c-6428-401c-b8b5-6891a0025b4f 64376-655 HUMAN PRESCRIPTION DRUG METHIMAZOLE METHIMAZOLE TABLET ORAL 20120307 ANDA ANDA202068 Boca Pharmacal, LLC METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 64376-656_c3ba2f6c-6428-401c-b8b5-6891a0025b4f 64376-656 HUMAN PRESCRIPTION DRUG METHIMAZOLE METHIMAZOLE TABLET ORAL 20120307 ANDA ANDA202068 Boca Pharmacal, LLC METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 64376-657_53ab6f1f-b3b8-4051-b45d-a5c522e9b8a4 64376-657 HUMAN PRESCRIPTION DRUG BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP ORAL 20140721 ANDA ANDA202940 Boca Pharmacal, LLC BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 10; 30 mg/5mL; mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 64376-802_a48d1ddc-ead7-4b80-823e-219bbf3ce88d 64376-802 HUMAN PRESCRIPTION DRUG FE C Tab Plus Vitamin C (Ascorbic Acid), Carbonyl Iron, Folic Acid, Vitamin B-12 (Cyanocobalamin) TABLET ORAL 20110331 UNAPPROVED DRUG OTHER Boca Pharmacal, LLC ASCORBIC ACID; CYANOCOBALAMIN; FOLIC ACID; IRON PENTACARBONYL 250; 25; 1; 100 mg/1; ug/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 64376-803_f14a4a6a-8425-4d82-a904-654a49572f06 64376-803 HUMAN PRESCRIPTION DRUG FE C Tab Iron, Vitamin C TABLET ORAL 20100819 UNAPPROVED DRUG OTHER Boca Pharmacal, LLC ASCORBIC ACID; IRON PENTACARBONYL 250; 100 mg/1; mg/1 64376-809_a751fe4b-9ac3-4548-b33f-eb2205537447 64376-809 HUMAN PRESCRIPTION DRUG Ferrous Sulfate Iron TABLET ORAL 20100914 UNAPPROVED DRUG OTHER Boca Pharmacal, LLC FERROUS SULFATE 65 mg/1 64376-811_50874ab0-380d-41d9-8729-0544743c3df1 64376-811 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl Phenazopyridine HCl TABLET ORAL 20100910 UNAPPROVED DRUG OTHER Boca Pharmacal, Inc PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 64376-812_50874ab0-380d-41d9-8729-0544743c3df1 64376-812 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl Phenazopyridine HCl TABLET ORAL 20100910 UNAPPROVED DRUG OTHER Boca Pharmacal, Inc PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 64376-813_7a84138c-bef7-4e5a-a23b-5e0e07afe020 64376-813 HUMAN PRESCRIPTION DRUG Multi-Vitamin With Fluoride Vitamin A, Vitamin D, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Fluoride Ion, Ascorbic Acid, .Alpha.-Tocopherol-Acetate-DL, Cyanocobalamin TABLET, CHEWABLE ORAL 20111228 UNAPPROVED DRUG OTHER Boca Pharmacal, Inc .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; FLUORIDE ION; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D 15; 60; 4.5; .25; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 64376-814_c2b5477a-6d4e-4ae0-bc9e-33b47de07060 64376-814 HUMAN PRESCRIPTION DRUG Multi-Vitamin Vitamin A, Vitamin D, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Fluoride Ion, Ascorbic Acid, Alpha-Tocopherol-Acetate-DL, Cyanocobalamin TABLET, CHEWABLE ORAL 20111228 UNAPPROVED DRUG OTHER Boca Pharmacal, Inc .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; FLUORIDE ION; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D 15; 60; 4.5; .5; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 64376-815_7931d636-99fd-4c84-8150-71010338e644 64376-815 HUMAN PRESCRIPTION DRUG Multi-Vitamin Vitamin A, Vitamin D, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Fluoride Ion, Ascorbic Acid, Alpha-Tocopherol-Acetate-DL, Cyanocobalamin TABLET, CHEWABLE ORAL 20110906 UNAPPROVED DRUG OTHER Boca Pharmacal, Inc .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; FLUORIDE ION; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D 15; 60; 4.5; 1; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 64376-816_adba00af-c8a8-4a00-82a3-6d342965302d 64376-816 HUMAN PRESCRIPTION DRUG PreNatal Vitamins Plus PreNatal Vitamins Plus TABLET ORAL 20110415 UNAPPROVED DRUG OTHER Boca Pharmacal, Inc. .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CALCIUM; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A; ZINC 22; 120; 200; 400; 2; 12; 1; 27; 20; 10; 3; 1.84; 4000; 25 mg/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 64376-820_238d8cdc-f8e4-4066-b1f6-c2e7eaa814ac 64376-820 HUMAN PRESCRIPTION DRUG Multi-Vitamin Fluoride Drops Vitamin A, Vitamin C, Vitamin D, Vitamin E, Vitamin B1, Vitamin B2, Vitamin B12, Niacin, Vitamin B6, Flouride SOLUTION ORAL 20110504 UNAPPROVED DRUG OTHER Boca Pharmacal, LLC .ALPHA.-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FLUORIDE ION; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A 5; 35; 400; 2; .25; 8; .4; .6; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 64376-821_b0401f51-748e-43e0-a387-fdddf6adfd98 64376-821 HUMAN PRESCRIPTION DRUG Multi-Vitamin Fluoride and Iron Drops Vitamin A, Vitamin C, Vitamin D, Vitamin E, Vitamin B1, Vitamin B2, Niacin, Vitamin B6, Iron, Fluoride SOLUTION ORAL 20110420 UNAPPROVED DRUG OTHER Boca Pharmacal, LLC .ALPHA.-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; FLUORIDE ION; IRON; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A 5; 35; 400; .25; 10; 8; .4; .6; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 64376-822_d27e1029-6d7a-4df6-87d5-8b216e1d5be8 64376-822 HUMAN PRESCRIPTION DRUG Multi-Vitamin Fluoride Drops Vitamin A, Vitamin C, Vitamin D, Vitamin E, Vitamin B1, Vitamin B2, Vitamin B12, Niacin, Vitamin B6, Fluoride SOLUTION ORAL 20110606 UNAPPROVED DRUG OTHER Boca Pharmacal, LLC .ALPHA.-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FLUORIDE ION; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A 5; 35; 400; 2; .5; 8; .4; .6; .5; 1500 [iU]/mL; mg/mL; [iU]/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 64376-823_a0b3108e-5f95-4ae9-877c-28a3f0b86267 64376-823 HUMAN PRESCRIPTION DRUG Triple-Vitamin Drops with Fluoride Vitamins A, C, D and Fluoride SOLUTION/ DROPS ORAL 20110614 UNAPPROVED DRUG OTHER Boca Pharmacal, LLC ASCORBIC ACID; CHOLECALCIFEROL; SODIUM FLUORIDE; VITAMIN A PALMITATE 35; 400; .25; 1500 mg/mL; [iU]/mL; mg/mL; [iU]/mL Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC] 64380-715_fc47ecb4-3295-4d26-b4b3-ebb15a064c11 64380-715 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20090514 ANDA ANDA077928 Strides Arcolab Limited MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 64380-716_fc47ecb4-3295-4d26-b4b3-ebb15a064c11 64380-716 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20090514 ANDA ANDA077928 Strides Arcolab Limited MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 64380-720_bdc7ee4c-4ab3-408a-9dc4-f2a355405ce5 64380-720 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20140813 ANDA ANDA090687 Strides Arcolab Limited TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 64380-721_bdc7ee4c-4ab3-408a-9dc4-f2a355405ce5 64380-721 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20140813 ANDA ANDA090687 Strides Arcolab Limited TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 64380-722_bdc7ee4c-4ab3-408a-9dc4-f2a355405ce5 64380-722 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20140813 ANDA ANDA090687 Strides Arcolab Limited TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 64380-725_c0e3198c-2e41-44b8-aa53-0163e9a9a518 64380-725 HUMAN PRESCRIPTION DRUG Mycophenolate mofetil Mycophenolate mofetil TABLET, FILM COATED ORAL 20101106 ANDA ANDA090456 Strides Arcolab Limited MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 64380-726_c0e3198c-2e41-44b8-aa53-0163e9a9a518 64380-726 HUMAN PRESCRIPTION DRUG Mycophenolate mofetil Mycophenolate mofetil CAPSULE ORAL 20101106 ANDA ANDA090055 Strides Arcolab Limited MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 64380-732_11118c4c-bcbe-4b46-a7fb-54d66013139d 64380-732 HUMAN OTC DRUG IBUPROFEN AND DIPHENHYDRAMINE HCL IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED ORAL 20120305 ANDA ANDA200888 Strides Arcolab Limited DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25; 200 mg/1; mg/1 64380-734_7360ea44-d0db-471f-a041-d7c1e37b09ed 64380-734 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20130630 ANDA ANDA200770 Strides Arcolab Limited HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 64380-735_7360ea44-d0db-471f-a041-d7c1e37b09ed 64380-735 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20130630 ANDA ANDA200770 Strides Arcolab Limited HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 64380-736_7360ea44-d0db-471f-a041-d7c1e37b09ed 64380-736 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20130630 ANDA ANDA200770 Strides Arcolab Limited HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 64380-737_4e3f197f-4156-4c7f-8820-509f6ac46fd4 64380-737 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20140516 ANDA ANDA090455 Strides Arcolab Limited ERGOCALCIFEROL 1.25 1/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 64380-741_b863221f-e1ea-443a-b600-489dc07d18cb 64380-741 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20140905 ANDA ANDA202330 Strides Arcolab Limited BUSPIRONE HYDROCHLORIDE 5 mg/1 64380-742_b863221f-e1ea-443a-b600-489dc07d18cb 64380-742 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20140905 ANDA ANDA202330 Strides Arcolab Limited BUSPIRONE HYDROCHLORIDE 10 mg/1 64380-743_b863221f-e1ea-443a-b600-489dc07d18cb 64380-743 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20140905 ANDA ANDA202330 Strides Arcolab Limited BUSPIRONE HYDROCHLORIDE 15 mg/1 64380-744_b863221f-e1ea-443a-b600-489dc07d18cb 64380-744 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20140905 ANDA ANDA202330 Strides Arcolab Limited BUSPIRONE HYDROCHLORIDE 30 mg/1 64380-746_fa9982a1-2968-4ca4-9802-023be77ce427 64380-746 HUMAN PRESCRIPTION DRUG pramipexole dihydrochloride pramipexole dihydrochloride TABLET ORAL 20140617 ANDA ANDA202702 Strides Arcolab Limited PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64380-747_fa9982a1-2968-4ca4-9802-023be77ce427 64380-747 HUMAN PRESCRIPTION DRUG pramipexole dihydrochloride pramipexole dihydrochloride TABLET ORAL 20140617 ANDA ANDA202702 Strides Arcolab Limited PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64380-748_fa9982a1-2968-4ca4-9802-023be77ce427 64380-748 HUMAN PRESCRIPTION DRUG pramipexole dihydrochloride pramipexole dihydrochloride TABLET ORAL 20140617 ANDA ANDA202702 Strides Arcolab Limited PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64380-749_fa9982a1-2968-4ca4-9802-023be77ce427 64380-749 HUMAN PRESCRIPTION DRUG pramipexole dihydrochloride pramipexole dihydrochloride TABLET ORAL 20140617 ANDA ANDA202702 Strides Arcolab Limited PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64380-750_fa9982a1-2968-4ca4-9802-023be77ce427 64380-750 HUMAN PRESCRIPTION DRUG pramipexole dihydrochloride pramipexole dihydrochloride TABLET ORAL 20140617 ANDA ANDA202702 Strides Arcolab Limited PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64380-751_fa9982a1-2968-4ca4-9802-023be77ce427 64380-751 HUMAN PRESCRIPTION DRUG pramipexole dihydrochloride pramipexole dihydrochloride TABLET ORAL 20140617 ANDA ANDA202702 Strides Arcolab Limited PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64380-752_32b7b8d9-4ad2-415b-8b8b-cee4e7815062 64380-752 HUMAN PRESCRIPTION DRUG Methoxsalen Methoxsalen CAPSULE, LIQUID FILLED ORAL 20140613 ANDA ANDA202687 Strides Arcolab Limited METHOXSALEN 10 mg/1 Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE],Psoralen [EPC],Psoralens [Chemical/Ingredient] 64380-758_b844c953-d877-467d-b295-0312dd7a8eb9 64380-758 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20110728 ANDA ANDA090912 Strides Arcolab Limited ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 64380-759_b844c953-d877-467d-b295-0312dd7a8eb9 64380-759 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20110728 ANDA ANDA090912 Strides Arcolab Limited ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 64380-760_b844c953-d877-467d-b295-0312dd7a8eb9 64380-760 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20110728 ANDA ANDA090912 Strides Arcolab Limited ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 64380-773_44a4c002-c8e6-407c-9e25-9b81d240e50c 64380-773 HUMAN PRESCRIPTION DRUG imiquimod imiquimod CREAM TOPICAL 20140707 ANDA ANDA202002 Strides Arcolab Limited IMIQUIMOD 50 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 64395-0001_efff3240-b679-41ce-a00e-67b187a55bc5 64395-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980724 UNAPPROVED MEDICAL GAS Pacific Island Medical, Inc. OXYGEN 99 L/100L 64406-005_2fe79a74-5cba-4f35-a815-86a805b28de9 64406-005 HUMAN PRESCRIPTION DRUG Tecfidera dimethyl fumarate CAPSULE ORAL 20130327 NDA NDA204063 Biogen Idec Inc. DIMETHYL FUMARATE 120 mg/1 64406-006_2fe79a74-5cba-4f35-a815-86a805b28de9 64406-006 HUMAN PRESCRIPTION DRUG Tecfidera dimethyl fumarate CAPSULE ORAL 20130327 NDA NDA204063 Biogen Idec Inc. DIMETHYL FUMARATE 240 mg/1 64406-007_2fe79a74-5cba-4f35-a815-86a805b28de9 64406-007 HUMAN PRESCRIPTION DRUG Tecfidera dimethyl fumarate KIT 20130327 NDA NDA204063 Biogen Idec Inc. 64406-008_71090264-a2ff-4cdf-97ce-689d6d5d1a11 64406-008 HUMAN PRESCRIPTION DRUG TYSABRI natalizumab INJECTION INTRAVENOUS 20041123 BLA BLA125104 Biogen Idec Inc. NATALIZUMAB 300 mg/15mL Integrin Receptor Antagonist [EPC],Integrin Receptor Antagonists [MoA] 64406-011_167018ea-b900-4e2a-b4cd-93eae24109cc 64406-011 HUMAN PRESCRIPTION DRUG Plegridy Pen peginterferon beta-1a INJECTION, SOLUTION SUBCUTANEOUS 20140815 BLA BLA125499 Biogen Idec Inc. PEGINTERFERON BETA-1A 125 ug/.5mL 64406-012_167018ea-b900-4e2a-b4cd-93eae24109cc 64406-012 HUMAN PRESCRIPTION DRUG Plegridy Pen Starter Kit peginterferon beta-1a KIT 20140815 BLA BLA125499 Biogen Idec Inc. 64406-015_167018ea-b900-4e2a-b4cd-93eae24109cc 64406-015 HUMAN PRESCRIPTION DRUG Plegridy Prefilled Syringe peginterferon beta-1a INJECTION, SOLUTION SUBCUTANEOUS 20140815 BLA BLA125499 Biogen Idec Inc. PEGINTERFERON BETA-1A 125 ug/.5mL 64406-016_167018ea-b900-4e2a-b4cd-93eae24109cc 64406-016 HUMAN PRESCRIPTION DRUG Plegridy Prefilled Syringe Starter Kit peginterferon beta-1a KIT 20140815 BLA BLA125499 Biogen Idec Inc. 64406-801_4be76b39-9dc9-45d4-9efe-8149f9d8ebab 64406-801 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Idec Inc. 64406-802_4be76b39-9dc9-45d4-9efe-8149f9d8ebab 64406-802 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Idec Inc. 64406-803_4be76b39-9dc9-45d4-9efe-8149f9d8ebab 64406-803 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Idec Inc. 64406-804_4be76b39-9dc9-45d4-9efe-8149f9d8ebab 64406-804 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Idec Inc. 64406-805_4be76b39-9dc9-45d4-9efe-8149f9d8ebab 64406-805 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Idec Inc. 64406-806_4be76b39-9dc9-45d4-9efe-8149f9d8ebab 64406-806 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Idec Inc. 64406-807_4be76b39-9dc9-45d4-9efe-8149f9d8ebab 64406-807 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Idec Inc. 64406-911_29d63951-3497-4b1b-be49-21426fbb3efe 64406-911 PLASMA DERIVATIVE ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140505 BLA BLA125444 Biogen Idec Inc. 64406-922_29d63951-3497-4b1b-be49-21426fbb3efe 64406-922 PLASMA DERIVATIVE ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140505 BLA BLA125444 Biogen Idec Inc. 64406-933_29d63951-3497-4b1b-be49-21426fbb3efe 64406-933 PLASMA DERIVATIVE ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140505 BLA BLA125444 Biogen Idec Inc. 64406-944_29d63951-3497-4b1b-be49-21426fbb3efe 64406-944 PLASMA DERIVATIVE ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140505 BLA BLA125444 Biogen Idec Inc. 64418-1122_47802510-e197-4a3c-a112-a01fb9d95017 64418-1122 HUMAN OTC DRUG Senna sennosides TABLET ORAL 20140919 OTC MONOGRAPH NOT FINAL part334 Ideal Protein of America Inc. SENNOSIDES A AND B 8.6 mg/1 64453-0100_96fd18f2-36a9-445e-a652-c7707ad79486 64453-0100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980512 UNAPPROVED MEDICAL GAS PhilCare Home Medical Equipment, Inc. OXYGEN 99 L/100L 64454-0001_7fd63ee5-6b49-435d-bdf2-06533f705572 64454-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980413 UNAPPROVED MEDICAL GAS Great Lakes Home Healthcare Services OXYGEN 99 L/100L 64455-063_1e827ec4-d44b-443e-9a19-74ee4d628c79 64455-063 HUMAN PRESCRIPTION DRUG Ativan lorazepam TABLET ORAL 20100316 20150131 NDA NDA017794 BTA Pharmaceuticals Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64455-064_1e827ec4-d44b-443e-9a19-74ee4d628c79 64455-064 HUMAN PRESCRIPTION DRUG Ativan lorazepam TABLET ORAL 20100316 20150131 NDA NDA017794 BTA Pharmaceuticals Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64455-065_1e827ec4-d44b-443e-9a19-74ee4d628c79 64455-065 HUMAN PRESCRIPTION DRUG Ativan lorazepam TABLET ORAL 20100316 20150131 NDA NDA017794 BTA Pharmaceuticals Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64455-106_fc102549-65f1-4a29-8d21-c70511888b88 64455-106 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130101 ANDA ANDA090071 BTA Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64455-107_fc102549-65f1-4a29-8d21-c70511888b88 64455-107 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130101 ANDA ANDA090071 BTA Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64455-108_fc102549-65f1-4a29-8d21-c70511888b88 64455-108 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130101 ANDA ANDA090071 BTA Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64455-152_6f29e247-308c-4784-9912-805df2a260fc 64455-152 HUMAN PRESCRIPTION DRUG Isordil Titradose isosorbide dinitrate TABLET ORAL 20091001 20170531 NDA NDA012093 BTA Pharmaceuticals, Inc. ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 64455-192_6f29e247-308c-4784-9912-805df2a260fc 64455-192 HUMAN PRESCRIPTION DRUG Isordil Titradose isosorbide dinitrate TABLET ORAL 20091001 20151031 NDA NDA012093 BTA Pharmaceuticals, Inc. ISOSORBIDE DINITRATE 40 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 64455-799_c05cbfb8-362f-48b7-92f2-7b03ad94a1e1 64455-799 HUMAN PRESCRIPTION DRUG Cardizem CD Diltiazem Hydrochloride CAPSULE ORAL 20010411 20150531 NDA NDA020062 BTA Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 64455-993_ab1e4d2b-9c35-44b4-ac72-d7ccb2db2816 64455-993 HUMAN PRESCRIPTION DRUG ZOVIRAX acyclovir OINTMENT TOPICAL 20041029 20150813 NDA NDA018604 BTA PHARMACEUTICALS INC ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 64455-994_742f01bb-ab60-4b71-9c14-367b53f8e849 64455-994 HUMAN PRESCRIPTION DRUG ZOVIRAX acyclovir CREAM TOPICAL 20041029 20150208 NDA NDA021478 BTA PHARMACEUTICALS INC ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 64464-001_d651e6ec-0b82-42da-94c4-13be4641c4f1 64464-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS O2 Plus, Inc OXYGEN 99 L/100L 64471-185_567f8229-f7e2-415b-b687-7769befa0f92 64471-185 HUMAN OTC DRUG Wellness with Cherry Flavor Cough Syrup Althaea officinalis, Prunus virginiana, Inula helenium SYRUP ORAL 20131016 UNAPPROVED HOMEOPATHIC Source Naturals ALTHAEA OFFICINALIS ROOT; ANEMONE NEMOROSA; BRYONIA ALBA WHOLE; CAUSTICUM; EUCALYPTUS GLOBULUS LEAF; INULA HELENIUM ROOT; MARRUBIUM VULGARE; PHOSPHORUS; PRUNUS VIRGINIANA BARK; RUMEX CRISPUS ROOT; SANGUINARIA CANADENSIS ROOT; STRYCHNOS NUX-VOMICA SEED 1; 12; 12; 12; 6; 3; 3; 12; 1; 6; 6; 12 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL 64471-196_b9d86850-f2d7-4437-9128-7b930a476dff 64471-196 HUMAN OTC DRUG Allercetin NOT APPLICABLE TABLET, CHEWABLE ORAL 20140905 UNAPPROVED HOMEOPATHIC Source Naturals, Inc. AMBROSIA ARTEMISIIFOLIA; EUPHRASIA STRICTA; HISTAMINE DIHYDROCHLORIDE; LOBARIA PULMONARIA; POTASSIUM IODIDE; QUERCETIN; SCHOENOCAULON OFFICINALE SEED; SUCCINIC ACID 30; 6; 12; 6; 6; 12; 6; 12 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg 64471-330_40127dad-a783-4e4a-a5ce-042c8ea6aafb 64471-330 HUMAN OTC DRUG Wellness4Cough Syrup Cough Syrup Althaea officinalis, Prunus virginiana, Inula helenium SYRUP ORAL 20131016 UNAPPROVED HOMEOPATHIC Source Naturals ALTHAEA OFFICINALIS ROOT; BRYONIA ALBA WHOLE; CAUSTICUM; EUCALYPTUS GLOBULUS LEAF; INULA HELENIUM ROOT; MARRUBIUM VULGARE; PHOSPHORUS; PRUNUS VIRGINIANA BARK; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SANGUINARIA CANADENSIS ROOT; STRYCHNOS NUX-VOMICA SEED 1; 12; 12; 6; 3; 3; 12; 1; 12; 6; 6; 12 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL 64477-001_a0ac7086-462d-4768-865e-89d00c3424cd 64477-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980305 UNAPPROVED MEDICAL GAS S & S Drug Inc. OXYGEN 99 L/100L 64481-0001_dd139f52-a647-4b74-919d-275441dee9bd 64481-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Life Quality Home Healthcare, Inc. OXYGEN 99 L/100L 64483-001_2406c6cd-654d-43a0-b062-e321939c25be 64483-001 HUMAN OTC DRUG Elastology Age Blocker Octinoxate, Octisalate, Titanium dioxide, and Oxybenzone CREAM TOPICAL 20000815 OTC MONOGRAPH NOT FINAL part352 Clientele, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7; 2; 3; 1.5 g/100g; g/100g; g/100g; g/100g 64483-003_e00e579f-8746-4bb9-b774-07117cc12d55 64483-003 HUMAN OTC DRUG Estro-Lift Day Therapy Octinoxate, Octisalate, Titanium dioxide, and Oxybenzone CREAM TOPICAL 20000815 OTC MONOGRAPH NOT FINAL part352 Clientele, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7; 2; 3; 1.5 g/100g; g/100g; g/100g; g/100g 64483-007_6e942baa-cce1-43cd-ab4a-dc24d39ac9e1 64483-007 HUMAN OTC DRUG Power Relief Menthol GEL TOPICAL 20040402 OTC MONOGRAPH NOT FINAL part348 Clientele, Inc. MENTHOL 2 mL/100mL 64495-2362_5f1399de-c671-42ae-be9d-29b06515c2f2 64495-2362 HUMAN OTC DRUG Bac Off Benzalkonium Chloride LIQUID TOPICAL 20080331 OTC MONOGRAPH NOT FINAL part333 Wayne Concept Manufacturing Co Inc BENZALKONIUM CHLORIDE .1 mL/100mL 64495-2363_dcb7d8da-afcf-4b9d-8c99-4974167f2beb 64495-2363 HUMAN OTC DRUG Bac Stop Benzalkonium Chloride LIQUID TOPICAL 20091031 OTC MONOGRAPH NOT FINAL part333 Wayne Concept Manufacturing Co Inc BENZALKONIUM CHLORIDE .13 mL/100mL 64495-2364_1c613209-3154-472e-b3b9-0ce2293ab893 64495-2364 HUMAN OTC DRUG Count Down CHLOROXYLENOL LIQUID TOPICAL 20110509 OTC MONOGRAPH NOT FINAL part333A Wayne Concept Manufacturing Co Inc CHLOROXYLENOL .3 mL/100mL 64495-2365_0edf7cb6-36b7-4297-ad62-65b814e739a3 64495-2365 HUMAN OTC DRUG BAC OFF BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120330 OTC MONOGRAPH NOT FINAL part333A Wayne Concept Manufacturing Co Inc BENZALKONIUM CHLORIDE .1 mL/100mL 64495-2366_2df3d2f3-3627-4e93-aad4-a56ecdb2d028 64495-2366 HUMAN OTC DRUG Bac Stop BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120330 OTC MONOGRAPH NOT FINAL part333A Wayne Concept Manufacturing Co Inc BENZALKONIUM CHLORIDE .13 mL/100mL 64495-2367_c1fcb3e4-08cc-4e9e-909b-aa8ff7348c22 64495-2367 HUMAN OTC DRUG Clear Bac CHLOROXYLENOL LIQUID TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part333A Wayne Concept Manufacturing Co Inc CHLOROXYLENOL .5 mL/100mL 64500-010_60ee92a5-9d0e-4324-bc51-cc352afb6ae7 64500-010 HUMAN OTC DRUG Cell to Cell Essence 70mL Dimethicone CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Coway Co., Ltd. DIMETHICONE .7 mg/70mL 64500-020_b0195772-6e47-4e30-9bc1-8f07f806aca7 64500-020 HUMAN OTC DRUG Cell to Cell Essence 20mL Dimethicone CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Coway Co., Ltd. DIMETHICONE .2 mg/20mL 64525-0542_4dbfa304-eb0f-4124-854d-a8da9b7710d4 64525-0542 HUMAN OTC DRUG Walgreens night time wal-flu severe cold and cough honey lemon flavor infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 64525-0543_23d8e934-b718-4b2b-9a4e-f0f227d3dbd9 64525-0543 HUMAN OTC DRUG CVS day time cough and severe cold berry infused with menthol and green tea flavors Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 64525-0544_6503ed4b-1640-45af-878f-bf4834903c09 64525-0544 HUMAN OTC DRUG CVS cough and severe cold night time honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 64525-0545_8189f7ee-2412-49b9-8105-238ef9216e9f 64525-0545 HUMAN OTC DRUG Our Family day time severe cold and Cough berry infused with menthol and green tea flavors Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 64525-0546_825509dc-274c-48e7-ab8c-dc6de9a38617 64525-0546 HUMAN OTC DRUG Our Family night time severe cold and cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 64525-0547_3ac9cb51-d6cc-4055-9dd6-1d8df9838644 64525-0547 HUMAN OTC DRUG Premier Value day time severe cold and cough berry infused with menthol and green tea flavors Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 64525-0548_4a00b112-c0dd-4085-9670-77bc63516568 64525-0548 HUMAN OTC DRUG Premier Value night time severe cold and cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 64525-0549_35b034c1-20c3-493f-9080-c65e1de5f365 64525-0549 HUMAN OTC DRUG Quality Choice day time severe cold and cough berry infused with menthol and green tea flavors Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 64525-0550_18184660-5a94-4382-88ae-57b03173da09 64525-0550 HUMAN OTC DRUG Quality Choice night time severe cold and cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 64525-0551_e6568ab9-b334-490f-b01d-64547dbae26f 64525-0551 HUMAN OTC DRUG Rite Aid day time severe cold and cough berry infused with menthol and green tea flavors Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 64525-0552_72d505db-2455-40bd-80a8-3fbd549e2a4d 64525-0552 HUMAN OTC DRUG Rite Aid night time severe cold and cough honey lemon with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 64525-0553_4e9e2353-9dc4-4365-a225-2aa983f797f8 64525-0553 HUMAN OTC DRUG TopCare day time severe cold and cough berry infused with menthol and green tea flavors Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 64525-0554_9185baab-1335-465a-b506-1edf485358b3 64525-0554 HUMAN OTC DRUG TopCare night time severe cold and cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 64525-0555_291c48e3-56a4-49df-ac9e-3dd0ce854821 64525-0555 HUMAN OTC DRUG Meijer Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20130930 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 64525-0556_c1406c8e-952a-4bfe-a911-790e911fd4a3 64525-0556 HUMAN OTC DRUG Careone night time severe cold and cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenyleprine HCL. GRANULE, FOR SOLUTION ORAL 20131024 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 64525-0557_0ac5b470-7f4f-49a0-9268-37dab299ed17 64525-0557 HUMAN OTC DRUG Best Choice Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20131030 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 64525-0558_7480243b-1f5e-4ece-97b7-721b577afd65 64525-0558 HUMAN OTC DRUG Meijer Nighttime Severe Cold and Cough Honey Lemon infused with Chamomile and White Tea Flavors Acetaminophen, Diphenhydramine HCl and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20130927 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 64525-0560_0a5a5ff3-d2fb-4a74-a076-c6bbcead51c6 64525-0560 HUMAN OTC DRUG Smart sense Nighttime Severe Cold and Cough Honey Lemon infused with Chamomile and White Tea Flavors Acetaminophen, Diphenhydramine HCl and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20131119 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 64525-0562_c609ec40-043d-4086-8f5a-00a8b8c19192 64525-0562 HUMAN OTC DRUG Best Choice Nighttime Severe Cold and Cough Honey Lemon infused with Chamomile and White Tea Flavors Acetaminophen, Diphenhydramine HCl and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20131119 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 64525-0701_6f046ff7-3b5a-4acf-86ec-c78cba4ec9e8 64525-0701 HUMAN OTC DRUG TopCare Cold and Sore Throat Lemon Flavor Acetaminophen, Pheniramine Maleate, Phenylephrine HCl GRANULE, FOR SOLUTION ORAL 20130926 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 20; 10 mg/1; mg/1; mg/1 64525-5131_82cb7042-2c4c-43bc-84e7-b4f1f1294be6 64525-5131 HUMAN OTC DRUG QC Cold and Hot Pain Relief Menthol PATCH TOPICAL 20110912 OTC MONOGRAPH NOT FINAL part348 Quality Home Products MENTHOL 400 mg/1 64525-5382_d66a67f2-678d-402a-92ad-c08b83ec8a5f 64525-5382 HUMAN OTC DRUG QC Diaper Rash Zinc Oxide CREAM TOPICAL 20110912 OTC MONOGRAPH FINAL part347 Quality Home Products ZINC OXIDE .1 g/g 64525-5565_ce7db22a-c116-4003-b991-63bd1f4689b9 64525-5565 HUMAN OTC DRUG Quality Choice Muscle and Joint Menthol GEL TOPICAL 20110916 OTC MONOGRAPH NOT FINAL part348 Quality Home Products MENTHOL 2.5 g/100g 64533-000_7bf5069b-3d80-4018-8297-ee4f73f67b39 64533-000 HUMAN OTC DRUG LidAll Lidocaine PATCH TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part348 MedVantage Pharmaceutical, LLC LIDOCAINE; MENTHOL 4; 1 g/100g; g/100g 64536-0114_6a4ab3c7-8a15-4488-be94-8b320d086832 64536-0114 HUMAN OTC DRUG Soft Care Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20140822 OTC MONOGRAPH NOT FINAL part333E Diversey, Inc. ALCOHOL 67.6 L/100L 64536-0807_cdd555f9-4e07-4278-8dc5-4a221161cc4c 64536-0807 HUMAN OTC DRUG Soft Care Foaming Antibacterial Hand Triclosan LIQUID TOPICAL 20101012 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN .5 mL/100mL 64536-1140_edfb603e-9b3d-436b-9bea-a6e3899689d5 64536-1140 HUMAN OTC DRUG Soft Care Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20140807 OTC MONOGRAPH NOT FINAL part333E Diversey, Inc. ALCOHOL 67.6 mL/100mL 64536-1268_d4a9ff51-aa1e-43e5-a63e-022d170060a3 64536-1268 HUMAN OTC DRUG Soft Care Foaming Instant Hand Sanitizer Benzethonium Chloride LIQUID TOPICAL 20101011 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. BENZETHONIUM CHLORIDE .2 mL/100mL 64536-1269_3876b4e6-f3d0-436d-9177-e265f40ca42b 64536-1269 HUMAN OTC DRUG Soft Care Hand Sanitizer Alcohol GEL TOPICAL 20101013 OTC MONOGRAPH NOT FINAL part333E Diversey, Inc. ALCOHOL 62 mL/100mL 64536-1271_1f34a03d-e484-48c7-bf45-27dc86513ee0 64536-1271 HUMAN OTC DRUG Soft Care Antibacterial-Antiseptic Hand CHLOROXYLENOL LIQUID TOPICAL 20101014 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. CHLOROXYLENOL .3 mL/100mL 64536-2220_c5d50d15-5856-454a-881c-fb392ea0e0c8 64536-2220 HUMAN OTC DRUG Soft Care Foam Select Antibacterial Triclosan TRICLOSAN LIQUID TOPICAL 20140814 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN .5 g/100mL 64536-2222_26c80f1e-cffc-444b-9e65-089033985b51 64536-2222 HUMAN OTC DRUG Soft Care Foam Select Antibacterial Hand Triclosan LIQUID TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN .5 g/100mL 64536-3851_f8acfc75-03a3-4867-a151-df1f563246d8 64536-3851 HUMAN OTC DRUG Soft Care Foam Antibacterial Hand Soap Triclosan LIQUID TOPICAL 20100430 OTC MONOGRAPH NOT FINAL part333 Johnson Diversey, Inc. TRICLOSAN .5 mL/100mL 64536-4350_fbd9b44b-e159-48c2-aa89-d0e1f59d1446 64536-4350 HUMAN OTC DRUG Soft Care Neutra Germ Antibacterial Triclosan LIQUID TOPICAL 20130615 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN .55 g/100mL 64536-4351_69bb1b6c-5958-4438-a5ec-7cc49b632954 64536-4351 HUMAN OTC DRUG Soft Care Neutra Germ Antibacterial Triclosan LIQUID TOPICAL 20130615 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN .55 g/100mL 64536-5471_d427b88e-ad12-4f81-bdbc-bb47c7d9c857 64536-5471 HUMAN OTC DRUG Soft Care Antiseptic Skin Cleanser Chloroxylenol LIQUID TOPICAL 20130615 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. CHLOROXYLENOL 1 g/100mL 64536-6102_c851a513-0e7e-4e17-b289-d96f6c08521f 64536-6102 HUMAN OTC DRUG Lever 2000 Antibacterial Triclosan LIQUID TOPICAL 20070927 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN .25 g/100mL 64536-7090_8ec2670f-f7de-46a5-9e40-028ea8e66965 64536-7090 HUMAN OTC DRUG Soft Care Antiseptic Skin Cleanser II TRICLOSAN LIQUID TOPICAL 20140609 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN .55 g/100mL 64536-7873_f6b1cfe6-9289-4c68-80c5-70bf04179aef 64536-7873 HUMAN OTC DRUG Soft Care Neutra Germ Fragrance Free Antibacterial Triclosan LIQUID TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN 5.5 g/L 64536-8730_4a6e3069-05af-4859-b861-e10801758c2d 64536-8730 HUMAN OTC DRUG Soft Care Neutra Germ Fragrance Free Antibacterial Triclosan LIQUID TOPICAL 20130615 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN 5.5 g/L 64536-8731_5fc76de6-0ac2-4f4b-919e-27cbb6097386 64536-8731 HUMAN OTC DRUG Soft Care Neutra Germ Fragrance Free Antibacterial Triclosan LIQUID TOPICAL 20130615 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN .55 g/100mL 64540-001_d742004c-3243-4185-bd24-4d7e99335ed1 64540-001 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 20110711 UNAPPROVED MEDICAL GAS Austin Respiratory Equipment,inc. OXYGEN 990 mL/L 64540-011_1bbad694-0919-4b50-9ba9-b84ea1461d23 64540-011 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 20110711 UNAPPROVED MEDICAL GAS Austin Respiratory Equipment,inc OXYGEN 990 mL/L 64543-044_1bf0effb-a480-45fc-8c8b-f014d92da442 64543-044 HUMAN OTC DRUG Rescon GG Guaifenesin and Phenylephrine Hydrochloride LIQUID ORAL 19990101 OTC MONOGRAPH FINAL part341 Capellon Pharmaceuticals, LLC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 100; 5 mg/5mL; mg/5mL 64543-097_bb30c57c-f743-495a-a0b1-9d1a8aabaa79 64543-097 HUMAN OTC DRUG Rescon Dexchlorpheniramine Maleate and Pseudoephedrine Hydrochloride TABLET, MULTILAYER ORAL 20120330 OTC MONOGRAPH FINAL part341 Capellon Pharmaceuticals, LLC DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 60 mg/1; mg/1 64543-105_85cac3dd-522d-44c2-88fc-0f69506c0900 64543-105 HUMAN OTC DRUG Rescon DM Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Pseudoephedrine Hydrochloride LIQUID ORAL 19990101 OTC MONOGRAPH FINAL part341 Capellon Pharmaceuticals, LLC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 10; 30 mg/5mL; mg/5mL; mg/5mL 64543-111_8a6e29af-c239-4f5c-9163-9c14b50d25bb 64543-111 HUMAN PRESCRIPTION DRUG Symax SL Hyoscyamine Sulfate TABLET, ORALLY DISINTEGRATING ORAL 19960901 UNAPPROVED DRUG OTHER Capellon Pharmaceuticals, LLC HYOSCYAMINE SULFATE .125 mg/1 64543-112_9f1758e4-cbea-4219-a99d-48384b1beed4 64543-112 HUMAN PRESCRIPTION DRUG Symax SR Hyoscyamine Sulfate TABLET, EXTENDED RELEASE ORAL 20091107 UNAPPROVED DRUG OTHER Capellon Pharmaceuticals, LLC HYOSCYAMINE SULFATE .375 mg/1 64543-114_b2e63767-9c9c-4fdc-9d26-20564830c981 64543-114 HUMAN PRESCRIPTION DRUG Symax FasTab Hyoscyamine Sulfate TABLET, ORALLY DISINTEGRATING ORAL 20031101 UNAPPROVED DRUG OTHER Capellon Pharmaceuticals, LLC HYOSCYAMINE SULFATE .125 mg/1 64543-118_11a7ffa5-6f59-4f56-9dbf-6c9a49b7be1e 64543-118 HUMAN PRESCRIPTION DRUG Symax Duotab Hyoscyamine Sulfate TABLET, MULTILAYER, EXTENDED RELEASE ORAL 20091107 UNAPPROVED DRUG OTHER Capellon Pharmaceuticals, LLC HYOSCYAMINE SULFATE .375 mg/1 64543-125_fa027c4c-35bf-4734-a250-b4882aa1d7dc 64543-125 HUMAN OTC DRUG Liquituss GG guaifenesin LIQUID ORAL 20120615 OTC MONOGRAPH FINAL part341 Capellon Pharmaceuticals, LLC GUAIFENESIN 200 mg/5mL 64545-0001_278685ee-49c9-46bb-8607-4f9891bb5f01 64545-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040516 UNAPPROVED MEDICAL GAS P & R Home IV Service OXYGEN 99 L/100L 64578-0055_ef6e29fb-0e1d-4751-842c-a091b5857c83 64578-0055 HUMAN OTC DRUG Agri-Chord Homeopathic Liquid LIQUID ORAL 20141117 UNAPPROVED HOMEOPATHIC Energetix Corp ARSENIC TRIOXIDE; ATROPA BELLADONNA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CUPRIC SULFATE; FUMARIC ACID; GALIUM APARINE; KEROSENE; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PORK LIVER; POTASSIUM IODIDE; SARSAPARILLA; SILICON DIOXIDE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA PANCREAS; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK; ZINC PHOSPHIDE 12; 12; 6; 12; 30; 30; 6; 30; 12; 30; 12; 30; 4; 9; 30; 12; 30; 30; 9; 9; 9; 4; 4; 30 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0056_05078116-2b4d-4b25-b242-306d4afd9d8e 64578-0056 HUMAN OTC DRUG Aller-Chord Food Homeopathic Liquid LIQUID ORAL 20140808 UNAPPROVED HOMEOPATHIC Energetix Corp ACETALDEHYDE; ACETIC ACID; ALPINE STRAWBERRY; ANHYDROUS CITRIC ACID; CAFFEINE; CALCIUM SULFATE ANHYDROUS; CORTISONE ACETATE; COW MILK; ECHINACEA PURPUREA; EGG PHOSPHOLIPIDS; ESTRONE; FUMARIC ACID; GALLIC ACID MONOHYDRATE; HISTAMINE DIHYDROCHLORIDE; HYDRANGEA ARBORESCENS ROOT; LIMULUS POLYPHEMUS; LYCOPODIUM CLAVATUM SPORE; PARAFFIN; PHOSPHORIC ACID; PORK LIVER; SACCHAROMYCES CEREVISIAE; SILICON DIOXIDE; SILVER NITRATE; SODIUM BICARBONATE; SODIUM CHLORIDE; SOLANUM LYCOPERSICUM; STRYCHNOS NUX-VOMICA SEED; SUCROSE; SUS SCROFA ADRENAL GLAND; TARTARIC ACID 12; 15; 15; 15; 15; 15; 20; 15; 6; 15; 15; 15; 12; 12; 6; 15; 12; 15; 15; 9; 15; 15; 10; 15; 12; 15; 12; 15; 9; 15 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0057_4e9d37ed-c94e-4c1c-a7c3-def07e81dc28 64578-0057 HUMAN OTC DRUG Aller-Chord A Homeopathic Liquid LIQUID ORAL 20140929 UNAPPROVED HOMEOPATHIC Energetix Corp ALFALFA; AMBROSIA ARTEMISIIFOLIA; ANHYDROUS CITRIC ACID; BRYONIA ALBA ROOT; COUMARIN; EUPHRASIA STRICTA; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; JUNIPER BERRY; ONION; PHOSPHORUS; PORK LIVER; PULSATILLA VULGARIS; SODIUM SULFATE; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA NASAL MUCOSA; SYMPLOCARPUS FOETIDUS ROOT; TANACETUM VULGARE TOP; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER 9; 6; 12; 6; 12; 6; 9; 12; 9; 6; 12; 9; 12; 12; 9; 12; 9; 9; 9; 9; 9; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0058_dddedd98-3d07-4f5e-83da-c9fb046f6b3e 64578-0058 HUMAN OTC DRUG Amoeba-Chord Homeopathic Liquid LIQUID ORAL 20141022 UNAPPROVED HOMEOPATHIC Energetix Corp ALPINE STRAWBERRY; BAPTISIA TINCTORIA ROOT; CAJUPUT OIL; CAPSICUM; CINCHONA OFFICINALIS BARK; ELYMUS REPENS ROOT; GENTIANA LUTEA ROOT; LYCOPODIUM CLAVATUM SPORE; PORK LIVER; PULSATILLA VULGARIS; QUASSIA AMARA WOOD; RANCID BEEF; SENNA LEAF; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA NASAL MUCOSA; SUS SCROFA PANCREAS; WORMWOOD 4; 4; 6; 5; 12; 4; 6; 12; 9; 12; 4; 30; 4; 12; 9; 9; 9; 6 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0059_199bae35-14ee-48ae-9539-cbc59783a126 64578-0059 HUMAN OTC DRUG Bacteria-Chord Homeopathic Liquid LIQUID ORAL 20140307 UNAPPROVED HOMEOPATHIC Energetix Corp ACHILLEA MILLEFOLIUM; ARCTIUM LAPPA ROOT; ATROPA BELLADONNA; AZADIRACHTA INDICA BARK; BERBERIS VULGARIS ROOT BARK; CANDIDA ALBICANS; CEANOTHUS AMERICANUS LEAF; CENTELLA ASIATICA; CETRARIA ISLANDICA SUBSP. ISLANDICA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GINGER; GLYCYRRHIZA GLABRA; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MEASLES VIRUS; MYRRH; PEUMUS BOLDUS LEAF; PHOSPHORUS; PLANTAGO MAJOR; PORK LIVER; RANCID BEEF; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; SUS SCROFA PANCREAS 12; 4; 8; 8; 9; 30; 4; 6; 12; 12; 4; 6; 4; 4; 6; 30; 12; 9; 30; 4; 4; 12; 4; 9; 30; 4; 9; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0060_5170e2b6-3dd6-4068-927b-a0dbb06806d8 64578-0060 HUMAN OTC DRUG Medi-Chord Homeopathic Liquid LIQUID ORAL 20140806 UNAPPROVED HOMEOPATHIC Energetix Corp ACETIC ACID; ALUMINUM; ARCTIUM LAPPA ROOT; ASPIRIN; ATROPA BELLADONNA; BENZENE; CHLORAMPHENICOL; CHLORPROMAZINE; CORTICOTROPIN HUMAN; CORTISONE ACETATE; ELYMUS REPENS ROOT; ESTRONE; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; KEROSENE; LEAD; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; PHENACETIN; PHENYL SALICYLATE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PORK LIVER; POTASSIUM IODIDE; SARSAPARILLA; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER 18; 18; 4; 18; 12; 12; 18; 18; 18; 18; 4; 18; 4; 4; 18; 15; 12; 12; 18; 18; 12; 4; 9; 12; 4; 12; 9; 9; 4 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0061_473791a9-2e4e-4c33-bf31-a2c60a20fcee 64578-0061 HUMAN OTC DRUG Colo-Chord Homeopathic Liquid LIQUID ORAL 20141008 UNAPPROVED HOMEOPATHIC Energetix Corp ABELMOSCHUS MOSCHATUS SEED; ACTIVATED CHARCOAL; ARANEUS DIADEMATUS; ASAFETIDA; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BOS TAURUS BILE; BOS TAURUS COLOSTRUM; CANDIDA ALBICANS; COW MILK; ESCHERICHIA COLI; FRANGULA PURSHIANA BARK; LYCOPODIUM CLAVATUM SPORE; MANDRAGORA OFFICINARUM ROOT; MARSDENIA CONDURANGO BARK; MERCURIUS SOLUBILIS; PORK LIVER; RHEUM OFFICINALE ROOT; SELENIUM; SUS SCROFA NASAL MUCOSA; VERATRUM ALBUM ROOT 12; 15; 12; 12; 30; 4; 8; 8; 18; 12; 24; 4; 12; 12; 12; 12; 9; 4; 15; 9; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0062_61f09ae9-90e0-4037-81a6-e5100c8d6343 64578-0062 HUMAN OTC DRUG Dental-Chord Homeopathic Liquid LIQUID ORAL 20140904 UNAPPROVED HOMEOPATHIC Energetix Corp ACETIC ACID; AMMONIUM CHLORIDE; ARCTIUM LAPPA ROOT; CALCIUM FLUORIDE; COPPER; DELPHINIUM STAPHISAGRIA SEED; GLYCYRRHIZA GLABRA; GOLD; IRON; LACTOSE, X-RAY EXPOSED (1000 RAD); LEMON JUICE; MERCURIUS SOLUBILIS; MYRRH; PALLADIUM; PHENOL; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; SELENIUM; SILICON DIOXIDE; SILVER; SODIUM FLUORIDE; STILLINGIA SYLVATICA ROOT; SUS SCROFA BONE MARROW; TIN; TRIBASIC CALCIUM PHOSPHATE; TRIFOLIUM PRATENSE FLOWER; ZINC OXIDE 15; 15; 4; 12; 15; 6; 4; 15; 12; 30; 12; 12; 6; 15; 15; 15; 4; 15; 12; 15; 12; 4; 9; 15; 12; 4; 15 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0063_fb165889-d6be-494c-9c52-eca410622fcb 64578-0063 HUMAN OTC DRUG Gyne-Chord Homeopathic Liquid LIQUID ORAL 20141112 UNAPPROVED HOMEOPATHIC Energetix Corp ANGELICA SINENSIS ROOT; BLACK COHOSH; BORIC ACID; CANDIDA ALBICANS; CHAMAELIRIUM LUTEUM ROOT; DELPHINIUM STAPHISAGRIA SEED; ESTRONE; GOLD TRICHLORIDE; GOLDENSEAL; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; WOOD CREOSOTE; ZINC GLUCONATE 8; 6; 12; 12; 12; 12; 7; 15; 12; 12; 15; 12; 12; 12; 9; 9; 12; 9; 15; 8 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0064_1533c76a-4be5-4e4f-b97c-792acb48b13a 64578-0064 HUMAN OTC DRUG Hepata-Chord Homeopathic Liquid LIQUID ORAL 20141117 UNAPPROVED HOMEOPATHIC Energetix Corp ACETIC ACID; ALUMINUM OXIDE; ARCTIUM LAPPA ROOT; ASPIRIN; BENZENE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS HYPOTHALAMUS; CENTELLA ASIATICA; CHELIDONIUM MAJUS; CHELONE GLABRA; CHLORAMPHENICOL; CHLORPROMAZINE; CHOLESTEROL; CORTISONE ACETATE; ESTRONE; GAMBOGE; KEROSENE; MILK THISTLE; PARAFFIN; PHENACETIN; PHOSPHORUS; PORK LIVER; SILICON DIOXIDE; SODIUM SULFATE; TARAXACUM OFFICINALE; THYROID, UNSPECIFIED 18; 18; 4; 18; 12; 4; 12; 5; 4; 12; 18; 18; 12; 18; 18; 12; 18; 4; 18; 18; 12; 9; 12; 12; 4; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0065_113af6b7-d033-42ff-bd56-e58bbccfd852 64578-0065 HUMAN OTC DRUG HZ-Chord Homeopathic Liquid LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC Energetix Corp ANHYDROUS CITRIC ACID; BAPTISIA TINCTORIA ROOT; CEANOTHUS AMERICANUS LEAF; CENTELLA ASIATICA; DAPHNE MEZEREUM BARK; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; LARREA TRIDENTATA TOP; LYCOPODIUM CLAVATUM SPORE; MEASLES VIRUS; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED 12; 4; 6; 12; 12; 4; 12; 5; 12; 30; 12; 4; 12; 12; 12; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0067_49f4ca9a-a6a8-4b53-929f-ab27bb191f31 64578-0067 HUMAN OTC DRUG Lipo-Chord Homeopathic Liquid LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC Energetix Corp ACETIC ACID; ALUMINUM OXIDE; ARSENIC TRIOXIDE; ASPIRIN; BORAGE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CHLORAMPHENICOL; CHLORPROMAZINE; CHOLESTEROL; COD LIVER OIL; CORTICOTROPIN HUMAN; CORTISONE ACETATE; ESTRONE; FUMARIC ACID; KEROSENE; LEAD; LYCOPODIUM CLAVATUM SPORE; PHENACETIN; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM IODIDE; SILICON DIOXIDE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SUCROSE; TARAXACUM OFFICINALE; THYROID, UNSPECIFIED; TURNERA DIFFUSA LEAFY TWIG 18; 18; 30; 18; 4; 6; 12; 6; 18; 18; 12; 12; 18; 18; 18; 30; 18; 30; 30; 18; 30; 30; 30; 30; 30; 30; 30; 4; 9; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0068_1c4282a3-d407-47ae-b721-99fabc370bdf 64578-0068 HUMAN OTC DRUG Metal-Chord Homeopathic Liquid LIQUID ORAL 20140620 UNAPPROVED HOMEOPATHIC Energetix Corp .ALPHA.-LIPOIC ACID; ALUMINUM OXIDE; ARCTIUM LAPPA ROOT; ARSENIC; BERBERIS VULGARIS ROOT BARK; CADMIUM; CETRARIA ISLANDICA SUBSP. ISLANDICA; COPPER; CYSTEINE; GARLIC; GINGER; GLYCYRRHIZA GLABRA; LEAD; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; MILK THISTLE; ONION; PLANTAGO MAJOR; PORK LIVER; PYRIDOXINE HYDROCHLORIDE; SELENIUM; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER 12; 15; 4; 15; 4; 15; 12; 15; 12; 6; 6; 4; 15; 4; 15; 4; 6; 4; 9; 12; 15; 4; 12; 9; 4 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0071_258403fb-b3f7-4da0-a257-c5ed0cd0f3d9 64578-0071 HUMAN OTC DRUG MycoCan-Chord Homeopathic Liquid LIQUID ORAL 20140818 UNAPPROVED HOMEOPATHIC Energetix Corp ALUMINUM OXIDE; AVENA SATIVA FLOWERING TOP; CANDIDA ALBICANS; CEANOTHUS AMERICANUS LEAF; ECHINACEA ANGUSTIFOLIA; FLAX SEED; GAULTHERIA PROCUMBENS TOP; GOLDENSEAL; LACTIC ACID, L-; LITHIUM CARBONATE; PHENOL; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM BORATE; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; TELLURIUM; TEUCRIUM MARUM; ZINC 15; 4; 16; 4; 4; 6; 6; 4; 12; 12; 8; 12; 12; 15; 12; 8; 12; 4; 9; 9; 15; 6; 15 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0072_875bf5d3-4971-4551-8d9e-fa5ce709ddac 64578-0072 HUMAN OTC DRUG Neuro-Chord Homeopathic Liquid LIQUID ORAL 20140708 UNAPPROVED HOMEOPATHIC Energetix Corp ALUMINUM; AMANITA MUSCARIA FRUITING BODY; ARSENIC; CADMIUM; CITHARACANTHUS SPINICRUS; COENZYME A; CONIUM MACULATUM FLOWERING TOP; COPPER; GELSEMIUM SEMPERVIRENS ROOT; LATRODECTUS MACTANS; LEAD; NAJA NAJA VENOM; PHOSPHORUS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SARSAPARILLA; SUS SCROFA ADRENAL GLAND; THIAMINE HYDROCHLORIDE; TOXICODENDRON PUBESCENS LEAF; ZINC 15; 12; 15; 15; 30; 12; 12; 15; 30; 30; 15; 30; 12; 12; 12; 6; 9; 12; 12; 15 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0073_34a09bce-379d-4a1c-baad-93cdef3fc4eb 64578-0073 HUMAN OTC DRUG Para-Chord Homeopathic Liquid LIQUID ORAL 20140725 UNAPPROVED HOMEOPATHIC Energetix Corp ARTEMISIA ABROTANUM FLOWERING TOP; ARTEMISIA CINA PRE-FLOWERING TOP; ARTEMISIA VULGARIS ROOT; DRYOPTERIS FILIX-MAS ROOT; DYSPHANIA AMBROSIOIDES; GRAPHITE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PEUMUS BOLDUS LEAF; PUNICA GRANATUM ROOT BARK; SILICON DIOXIDE; SODIUM PHOSPHATE, DIBASIC; SPIGELIA ANTHELMIA; TANACETUM VULGARE TOP; TEUCRIUM MARUM; WHITE MUSTARD SEED 12; 5; 12; 4; 12; 12; 15; 4; 12; 12; 12; 6; 12; 5; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0074_4eb7b1f5-fe2d-439b-bc2f-353c72f77c92 64578-0074 HUMAN OTC DRUG Tox-Chord Homeopathic Liquid LIQUID ORAL 20141021 UNAPPROVED HOMEOPATHIC Energetix Corp ALFALFA; ALUMINUM OXIDE; BENZOIC ACID; CETRARIA ISLANDICA SUBSP. ISLANDICA; COMFREY ROOT; D&C BLACK NO. 2; ELYMUS REPENS ROOT; ESTRONE; FUCUS VESICULOSUS; FUMARIC ACID; KEROSENE; LEAD; PARAFFIN; PHENYL SALICYLATE; PHOSPHORIC ACID; PHOSPHORUS; PINE TAR; PLANTAGO MAJOR; PORK LIVER; POTASSIUM CARBONATE; PULSATILLA VULGARIS; RADIUM BROMIDE; RESORCINOL; SILICON DIOXIDE; SODIUM CHLORIDE; THYROID, UNSPECIFIED; TOBACCO LEAF; TURPENTINE OIL; WOOD CREOSOTE; ZINC OXIDE 4; 18; 18; 9; 4; 18; 4; 18; 5; 18; 18; 15; 18; 18; 12; 12; 18; 4; 9; 12; 12; 15; 18; 12; 12; 9; 30; 18; 18; 18 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0075_046fd557-17c6-4e36-8099-49998f60a0d8 64578-0075 HUMAN OTC DRUG Rena-Chord Homeopathic Liquid LIQUID ORAL 20141021 UNAPPROVED HOMEOPATHIC Energetix Corp AGATHOSMA BETULINA LEAF; ALUMINUM OXIDE; ANTIMONY; APIS MELLIFERA; ARCTOSTAPHYLOS UVA-URSI LEAF; ARSENIC; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CADMIUM; COBALT; COPPER; ECHINACEA ANGUSTIFOLIA; ELYMUS REPENS ROOT; EUTROCHIUM PURPUREUM ROOT; IRON; KEROSENE; LEAD; LITHIUM CARBONATE; LYTTA VESICATORIA; MERCURIC CHLORIDE; PLATINUM; PULSATILLA VULGARIS; SARSAPARILLA; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TITANIUM; VANADIUM; ZINC 6; 15; 15; 12; 5; 15; 4; 12; 15; 15; 15; 4; 4; 6; 15; 15; 15; 15; 8; 15; 15; 12; 5; 8; 6; 4; 12; 15; 15; 15 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0076_d88b235c-d8b2-4a10-8cb4-a9f52f7d3ed0 64578-0076 HUMAN OTC DRUG Thyro-Chord Homeopathic Liquid LIQUID ORAL 20140711 UNAPPROVED HOMEOPATHIC Energetix Corp .ALPHA.-KETOGLUTARIC ACID; ACETIC ACID; AMMONIUM CHLORIDE; ASPARAGUS; CHELIDONIUM MAJUS; COENZYME A; COPPER; ECHINACEA ANGUSTIFOLIA; FERROUS IODIDE; FUCUS VESICULOSUS; FUMARIC ACID; GENTIANA LUTEA ROOT; GLYCYRRHIZA GLABRA; GOLD; IODINE; MERCURIUS SOLUBILIS; NADIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PALLADIUM; PERSICARIA PUNCTATA; PHOSPHORIC ACID; POTASSIUM IODIDE; PULSATILLA VULGARIS; RANCID BEEF; SAGE; SILICON DIOXIDE; SILVER; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; THYROID, UNSPECIFIED; TIN; VANADIUM; ZINC OXIDE 12; 15; 15; 12; 4; 12; 15; 4; 12; 6; 12; 4; 4; 15; 8; 15; 12; 12; 15; 12; 12; 12; 12; 12; 8; 12; 15; 12; 12; 12; 9; 15; 15; 15 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0077_c2a0d336-8cc1-434a-b71d-f6443f14df27 64578-0077 HUMAN OTC DRUG Vac-Chord Homeopathic Liquid LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC Energetix Corp ALUMINUM OXIDE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; EGG PHOSPHOLIPIDS; GOLDENSEAL; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; MEASLES VIRUS; MERCURIUS SOLUBILIS; MILK THISTLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PEUMUS BOLDUS LEAF; PHYTOLACCA AMERICANA ROOT; RANCID BEEF; SILICON DIOXIDE; SULFUR; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 15; 12; 12; 4; 4; 4; 12; 4; 30; 16; 12; 12; 30; 15; 4; 12; 4; 4; 30; 12; 15; 4; 6; 9; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0078_c9509038-0547-4992-9448-7132e5e85224 64578-0078 HUMAN OTC DRUG Viru-Chord Homeopathic Liquid LIQUID ORAL 20140606 UNAPPROVED HOMEOPATHIC Energetix Corp ARCTIUM LAPPA ROOT; ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; GLYCYRRHIZA GLABRA; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LACHESIS MUTA VENOM; LARREA TRIDENTATA TOP; MAGNESIUM PHOSPHATE, DIBASIC; MEASLES VIRUS; MYRRH; NASTURTIUM AQUATICUM; PORK LIVER; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SAMBUCUS NIGRA FLOWERING TOP; SCUTELLARIA LATERIFLORA; STAR ANISE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ADRENAL GLAND; THIAMINE HYDROCHLORIDE; THYROID, UNSPECIFIED 4; 12; 12; 4; 6; 4; 4; 30; 30; 12; 12; 12; 30; 4; 6; 9; 12; 12; 4; 6; 12; 12; 9; 12; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0079_4f85ab0f-363f-423f-8a12-639da230215a 64578-0079 HUMAN OTC DRUG Adrenal-Tone Homeopathic Liquid LIQUID ORAL 20140521 UNAPPROVED HOMEOPATHIC Energetix Corp AVENA SATIVA FLOWERING TOP; EPINEPHRINE; GINKGO; GLYCYRRHIZA GLABRA; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; SARSAPARILLA; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED; VERATRUM ALBUM ROOT; ZINC 4; 12; 4; 4; 12; 12; 4; 12; 12; 12; 6; 12; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0080_c3dbaf59-8de6-486d-ad39-42f509691d65 64578-0080 HUMAN PRESCRIPTION DRUG Drainage-Tone Homeopathic Liquid LIQUID ORAL 20140109 UNAPPROVED HOMEOPATHIC Energetix Corp CALCIUM IODIDE; CAPSICUM; COD LIVER OIL; COENZYME A; ECHINACEA ANGUSTIFOLIA; EQUISETUM ARVENSE TOP; GOLDENSEAL; NADIDE; NITRIC ACID; PETROSELINUM CRISPUM; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; WHITE MUSTARD SEED 12; 6; 15; 8; 4; 6; 4; 8; 12; 4; 4; 4; 12; 4; 4 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 64578-0081_654d7d5f-f953-4efc-8b11-908a2911cc9b 64578-0081 HUMAN OTC DRUG Flu-Tone Homeopathic Liquid LIQUID ORAL 20131115 UNAPPROVED HOMEOPATHIC Energetix Corp AZADIRACHTA INDICA BARK; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; INFLUENZA A VIRUS; INFLUENZA B VIRUS; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; RANCID BEEF; SELENIUM; STILLINGIA SYLVATICA ROOT; SUS SCROFA NASAL MUCOSA 12; 4; 12; 15; 15; 4; 30; 12; 6; 4; 30; 30; 4; 9; 30; 12; 4; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0082_7ebdcc89-f1c0-4b62-9ef0-8eb5c9e20820 64578-0082 HUMAN OTC DRUG GB-Tone Homeopathic Liquid LIQUID ORAL 20140409 UNAPPROVED HOMEOPATHIC Energetix Corp AMMI VISNAGA FRUIT; ATROPINE SULFATE; BOS TAURUS BILE; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MILK THISTLE; PEUMUS BOLDUS LEAF; PODOPHYLLUM; PORK LIVER; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TARAXACUM OFFICINALE; VERONICASTRUM VIRGINICUM ROOT 12; 12; 8; 12; 4; 4; 12; 4; 4; 12; 9; 6; 4; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0083_d9a5035e-142a-43dd-b8f7-8dad688d48c5 64578-0083 HUMAN OTC DRUG Inflamma-Tone Homeopathic Liquid LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC Energetix Corp ACONITUM NAPELLUS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA 8; 8; 8; 8 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0084_f6f4e445-9c6f-4ad8-8e9a-140f91edcf9a 64578-0084 HUMAN OTC DRUG Kidney-Tone Homeopathic Label LIQUID ORAL 20131205 UNAPPROVED HOMEOPATHIC Energetix Corp AGRIMONIA EUPATORIA; ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; CALCIUM OXALATE MONOHYDRATE; CHONDRODENDRON TOMENTOSUM ROOT; ECHINACEA ANGUSTIFOLIA; EQUISETUM ARVENSE TOP; FERRUM PHOSPHORICUM; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PETROSELINUM CRISPUM; RUBIA TINCTORUM ROOT; SARSAPARILLA; SOLIDAGO VIRGAUREA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE 12; 5; 4; 12; 4; 4; 12; 12; 12; 12; 4; 12; 5; 5; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0085_a838f971-2241-473f-b5f2-e52dd6d0e88d 64578-0085 HUMAN OTC DRUG Hepatic-Tone Homeopathic Liquid LIQUID ORAL 20140529 UNAPPROVED HOMEOPATHIC Energetix Corp ANHYDROUS CITRIC ACID; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CYSTEINE; MAGNESIUM CHLORIDE; MILK THISTLE; PHOSPHORUS; PORK LIVER; QUASSIA AMARA WOOD; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; VERONICASTRUM VIRGINICUM ROOT 8; 12; 4; 8; 8; 8; 4; 12; 9; 4; 12; 12; 4; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0086_de54172a-239f-422f-865f-1cf17e6137e8 64578-0086 HUMAN OTC DRUG Lymph-Tone I Homeopathic Liquid LIQUID ORAL 20140410 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; APIS MELLIFERA; ARANEUS DIADEMATUS; ATROPA BELLADONNA; BOS TAURUS HYPOTHALAMUS; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PEUMUS BOLDUS LEAF; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM IODIDE; PULSATILLA VULGARIS; SCROPHULARIA NODOSA; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12; 4; 12; 12; 3; 12; 4; 9; 4; 12; 12; 12; 9; 12; 12; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0087_b137b0df-a035-4817-8037-76877f190175 64578-0087 HUMAN PRESCRIPTION DRUG Lymph-Tone II Homeopathic Liquid LIQUID ORAL 20140409 UNAPPROVED HOMEOPATHIC Energetix Corp AZADIRACHTA INDICA BARK; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS HYPOTHALAMUS; BUFO BUFO CUTANEOUS GLAND; COENZYME A; COLLINSONIA CANADENSIS ROOT; ECHINACEA ANGUSTIFOLIA; FERRUM PHOSPHORICUM; HORSE CHESTNUT; NADIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PEUMUS BOLDUS LEAF; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PINE TAR; PINUS SYLVESTRIS LEAFY TWIG; PULSATILLA VULGARIS; SILICON DIOXIDE; SODIUM CHLORIDE; STILLINGIA SYLVATICA ROOT; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; TRIBASIC CALCIUM PHOSPHATE; WOOD CREOSOTE 8; 12; 12; 12; 12; 12; 10; 6; 12; 12; 12; 12; 4; 30; 4; 6; 9; 12; 12; 12; 4; 9; 6; 12; 12; 15 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 64578-0088_64448bbf-949f-4963-97c0-ac3a95c808e3 64578-0088 HUMAN OTC DRUG Lymph-Tone III Homeopathic Liquid LIQUID ORAL 20140421 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; ARNICA MONTANA; BOS TAURUS HYPOTHALAMUS; CALCIUM IODIDE; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CEANOTHUS AMERICANUS LEAF; COENZYME A; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HERRING SPERM DNA; KIDNEY BEAN; NADIDE; NAJA NAJA VENOM; PEUMUS BOLDUS LEAF; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; RANCID BEEF; SILICON DIOXIDE; SODIUM SULFATE; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; VISCUM ALBUM FRUITING TOP 12; 12; 12; 12; 12; 30; 9; 12; 4; 12; 12; 4; 12; 15; 3; 15; 4; 9; 12; 12; 30; 15; 6; 12; 15; 9; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0089_964a6cbb-0e89-47d6-98c8-3dbebb001ce0 64578-0089 HUMAN PRESCRIPTION DRUG ReHydration Homeopathic Liquid LIQUID ORAL 20140113 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; ARABICA COFFEE BEAN; BOS TAURUS HYPOTHALAMUS; POTASSIUM PHOSPHATE, DIBASIC; SARSAPARILLA; SILICON DIOXIDE; SODIUM CHLORIDE; SUS SCROFA ADRENAL GLAND; TARAXACUM OFFICINALE; THYROID, UNSPECIFIED 12; 9; 12; 6; 4; 12; 8; 9; 4; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 64578-0090_9cfc4c56-fdf2-4cc4-8b91-77dd507d32d0 64578-0090 HUMAN OTC DRUG ReHydration Homeopathic Liquid LIQUID ORAL 20141117 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; ARABICA COFFEE BEAN; BOS TAURUS HYPOTHALAMUS; POTASSIUM PHOSPHATE, DIBASIC; SARSAPARILLA; SILICON DIOXIDE; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; TARAXACUM OFFICINALE; THYROID, UNSPECIFIED 12; 5; 12; 6; 4; 12; 8; 9; 4; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0091_2256866a-d1a1-429b-8e62-9a49091fcec7 64578-0091 HUMAN OTC DRUG Relax-Tone Homeopathic LIQUID ORAL 20131001 UNAPPROVED HOMEOPATHIC Energetix Corp ARABICA COFFEE BEAN; DELPHINIUM STAPHISAGRIA SEED; HOPS; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; VALERIAN 12; 12; 10; 12; 12; 4; 12; 12; 12; 12; 12; 4 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0092_b051af77-d33a-40d6-8cbc-2db23d7cd61b 64578-0092 HUMAN OTC DRUG Relief-Tone Homeopathic Liquid LIQUID ORAL 20131204 UNAPPROVED HOMEOPATHIC Energetix Corp ARNICA MONTANA; ATROPA BELLADONNA; COMFREY ROOT; CORTISONE ACETATE; HYPERICUM PERFORATUM 12; 6; 12; 24; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0093_9874926e-9407-4472-a7f2-49e7118af2c9 64578-0093 HUMAN PRESCRIPTION DRUG Sinus-Tone Homeopathic Liquid LIQUID ORAL 20140321 UNAPPROVED HOMEOPATHIC Energetix Corp ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; MERCURIC SULFIDE; MERCURIUS SOLUBILIS; NUTMEG; ONION; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SODIUM SULFATE; SUS SCROFA NASAL MUCOSA 4; 4; 12; 30; 6; 12; 12; 12; 12; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 64578-0094_36efcdcc-795f-4fd9-b3d4-424fd98a6fe9 64578-0094 HUMAN OTC DRUG Throat-Spray Tone Homeopathic Liquid LIQUID ORAL 20140908 UNAPPROVED HOMEOPATHIC Energetix Corp ACMELLA OLERACEA FLOWERING TOP; APIS MELLIFERA; ATROPA BELLADONNA ROOT; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CLOVE; GOLDENSEAL; LACHESIS MUTA VENOM; MENTHA PIPERITA; MERCURIUS SOLUBILIS; MYRRH; PHYTOLACCA AMERICANA ROOT; SAGE; THYMUS SERPYLLUM 2; 12; 12; 4; 15; 4; 1; 2; 12; 1; 12; 2; 4; 1; 2 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0095_6d023743-7aad-4b09-8186-70627ac9184b 64578-0095 HUMAN OTC DRUG Adaptopath Homeopathic Liquid LIQUID ORAL 20141022 UNAPPROVED HOMEOPATHIC Energetix Corp .ALPHA.-LIPOIC ACID; ADENOSINE CYCLIC PHOSPHATE; ANHYDROUS CITRIC ACID; AVENA SATIVA FLOWERING TOP; BOS TAURUS HYPOTHALAMUS; CAPSICUM; COD LIVER OIL; COENZYME A; COPPER; GINKGO; GLYCYRRHIZA GLABRA; IODINE; LEDUM PALUSTRE TWIG; MANGANESE ACETATE TETRAHYDRATE; NADIDE; PHOSPHORIC ACID; PICRIC ACID; RIBOFLAVIN; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER; SODIUM CARBONATE; SUS SCROFA ADRENAL GLAND; THIAMINE HYDROCHLORIDE; THYROID, UNSPECIFIED; VANADIUM 12; 8; 4; 4; 12; 4; 6; 8; 12; 4; 4; 12; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 9; 8; 9; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0096_cd87d8f9-9ca4-4e8d-bc16-757672492ca6 64578-0096 HUMAN OTC DRUG Adrenapath Homeopathic Liquid LIQUID ORAL 20140522 UNAPPROVED HOMEOPATHIC Energetix Corp CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; MILK THISTLE; PHOSPHORIC ACID; SODIUM CHLORIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED 4; 4; 12; 12; 12; 9; 12; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0097_d613715f-9ceb-407d-899a-32f585dea42e 64578-0097 HUMAN PRESCRIPTION DRUG Circulopath Homeopathic Liquid LIQUID ORAL 20140613 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; ARNICA MONTANA; BARIUM CHLORIDE DIHYDRATE; BORAGE; BOS TAURUS HYPOTHALAMUS; CHOLESTEROL; COENZYME A; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; GINKGO; GOLD; KIDNEY BEAN; LEMON JUICE; MAGNESIUM CHLORIDE; MAGNOLIA GRANDIFLORA FLOWER; NADIDE; PHOSPHORUS; POTASSIUM IODIDE; PRUNUS LAUROCERASUS LEAF; THYROID, UNSPECIFIED 10; 30; 12; 4; 12; 12; 10; 12; 6; 4; 12; 5; 4; 8; 4; 9; 30; 12; 10; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 64578-0098_6e7e87b1-cab4-4298-b0ba-5e7728510fde 64578-0098 HUMAN OTC DRUG Endopath-F Homeopathic Liquid LIQUID ORAL 20141006 UNAPPROVED HOMEOPATHIC Energetix Corp ANGELICA ARCHANGELICA ROOT; BLACK COHOSH; BOS TAURUS HYPOTHALAMUS; CHASTE TREE; FUCUS VESICULOSUS; GLYCYRRHIZA GLABRA; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED; ZANTHOXYLUM AMERICANUM BARK 6; 4; 12; 4; 4; 4; 12; 12; 9; 9; 12; 9; 4 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0099_b4ebdded-3bba-44ec-a621-13f0bd9f4be2 64578-0099 HUMAN OTC DRUG Endopath-M Homeopathic Liquid LIQUID ORAL 20141008 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; ASPARAGUS; AVENA SATIVA FLOWERING TOP; CADMIUM; CHASTE TREE; JUNIPER BERRY; LYCOPODIUM CLAVATUM SPORE; OVIS ARIES TESTICLE; PETROSELINUM CRISPUM; PULSATILLA VULGARIS; SARSAPARILLA; SAW PALMETTO; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; TURNERA DIFFUSA LEAFY TWIG 10; 6; 4; 15; 4; 4; 4; 9; 4; 6; 4; 4; 9; 12; 6 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0100_1fc5e32b-35c0-4586-83d9-5b4a61b38480 64578-0100 HUMAN OTC DRUG Hypothalmapath Homeopathic Liquid LIQUID ORAL 20140327 UNAPPROVED HOMEOPATHIC Energetix Corp BOS TAURUS HYPOTHALAMUS; CENTELLA ASIATICA; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; GLYCYRRHIZA GLABRA; PETROSELINUM CRISPUM; PYRIDOXINE HYDROCHLORIDE; SANDALWOOD OIL; SENNA LEAF; SILICON DIOXIDE; SUS SCROFA PITUITARY GLAND 12; 4; 12; 6; 4; 4; 12; 12; 8; 12; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0101_02533253-2c9d-4754-925e-28e303f84d90 64578-0101 HUMAN OTC DRUG Endocrinpath Homeopathic Liquid LIQUID ORAL 20141120 UNAPPROVED HOMEOPATHIC Energetix Corp ALFALFA; ANHYDROUS CITRIC ACID; BORAGE; BOS TAURUS HYPOTHALAMUS; CEANOTHUS AMERICANUS LEAF; CENTELLA ASIATICA; FUCUS VESICULOSUS; GINKGO; GLYCYRRHIZA GLABRA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; POTASSIUM PHOSPHATE, DIBASIC; SARSAPARILLA; SILICON DIOXIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA PANCREAS; SUS SCROFA PITUITARY GLAND; SYZYGIUM CUMINI SEED; TARAXACUM OFFICINALE; THYROID, UNSPECIFIED 15; 15; 15; 12; 4; 15; 15; 15; 15; 15; 4; 15; 15; 12; 9; 9; 12; 4; 15; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0102_80c6aaf2-80b0-42a4-9da9-2bf13c5fcdc0 64578-0102 HUMAN OTC DRUG Metabopath Homeopathic Liquid LIQUID ORAL 20140808 UNAPPROVED HOMEOPATHIC Energetix Corp .ALPHA.-KETOGLUTARIC ACID; ADENOSINE CYCLIC PHOSPHATE; ADENOSINE TRIPHOSPHATE DISODIUM; ANHYDROUS CITRIC ACID; ARCTIUM LAPPA ROOT; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; COENZYME A; FRANGULA PURSHIANA BARK; FUMARIC ACID; GLYCYRRHIZA GLABRA; HERRING SPERM DNA; MAGNESIUM PHOSPHATE, DIBASIC; MANGANESE ACETATE TETRAHYDRATE; NADIDE; NIACINAMIDE; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SACCHAROMYCES CEREVISIAE RNA; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SULFUR; THIAMINE HYDROCHLORIDE; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK; ZINC GLUCONATE 12; 8; 12; 8; 4; 4; 30; 12; 4; 12; 4; 30; 12; 10; 12; 6; 12; 6; 10; 30; 12; 12; 12; 12; 12; 12; 6; 9; 4; 4; 10 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0103_2e893b7c-4e32-4368-89e6-a1d987d5cf0d 64578-0103 HUMAN OTC DRUG Renapath Homeopathic Liquid LIQUID ORAL 20140606 UNAPPROVED HOMEOPATHIC Energetix Corp ARCTOSTAPHYLOS UVA-URSI LEAF; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BOS TAURUS HYPOTHALAMUS; BRYONIA ALBA ROOT; CHONDRODENDRON TOMENTOSUM ROOT; EUTROCHIUM PURPUREUM ROOT; HERRING SPERM DNA; HYDRANGEA ARBORESCENS ROOT; MERCURIC CHLORIDE; PETROSELINUM CRISPUM; RUBIA TINCTORUM ROOT; SARSAPARILLA; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; SUS SCROFA PANCREAS; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED 4; 10; 4; 12; 12; 10; 12; 12; 4; 12; 4; 6; 4; 4; 9; 9; 12; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0104_9ba485d9-1b99-4bd7-9604-9f5b96ab0673 64578-0104 HUMAN OTC DRUG Thyropath Homeopathic Liquid LIQUID ORAL 20140725 UNAPPROVED HOMEOPATHIC Energetix Corp AVENA SATIVA FLOWERING TOP; BORAGE; CHELIDONIUM MAJUS; FERROUS IODIDE; FUCUS VESICULOSUS; IODINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PORK LIVER; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED; ZINC 4; 4; 4; 12; 4; 12; 12; 12; 9; 12; 10; 9; 12; 9; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0105_ee04e1e9-1a86-412b-acb9-c1a6b1ea6bf2 64578-0105 HUMAN OTC DRUG Fields of Flowers Homeopathic Liquid LIQUID ORAL 20140818 UNAPPROVED HOMEOPATHIC Energetix Corp AESCULUS CARNEA FLOWER; AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWER; BROMUS RAMOSUS FLOWER; CALLUNA VULGARIS FLOWERING TOP; CARPINUS BETULUS FLOWERING TOP; CASTANEA SATIVA FLOWER; CENTAURIUM ERYTHRAEA FLOWER; CERATOSTIGMA WILLMOTTIANUM FLOWER; CICHORIUM INTYBUS FLOWER; CLEMATIS VITALBA FLOWER; FAGUS SYLVATICA FLOWERING TOP; GENTIANELLA AMARELLA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; HORSE CHESTNUT; HOTTONIA PALUSTRIS FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; IMPATIENS GLANDULIFERA FLOWER; JUGLANS REGIA FLOWERING TOP; LARIX DECIDUA FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWERING TOP; MALUS DOMESTICA FLOWER; MIMULUS GUTTATUS FLOWERING TOP; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PINUS SYLVESTRIS FLOWERING TOP; POPULUS TREMULA FLOWERING TOP; PRUNUS CERASIFERA FLOWER; QUERCUS ROBUR FLOWER; ROSA CANINA FLOWER; SALIX ALBA FLOWERING TOP; SCLERANTHUS ANNUUS FLOWERING TOP; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; ULEX EUROPAEUS FLOWER; ULMUS PROCERA FLOWERING TWIG; VERBENA OFFICINALIS FLOWERING TOP; VITIS VINIFERA FLOWERING TOP 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL 64578-0106_ab6cfb46-2700-496b-a6e3-a71d04bedb12 64578-0106 HUMAN OTC DRUG Fields of Flowers Homeopathic Liquid LIQUID ORAL 20140825 UNAPPROVED HOMEOPATHIC Energetix Corp AESCULUS CARNEA FLOWER; AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWER; BROMUS RAMOSUS FLOWER; CALLUNA VULGARIS FLOWERING TOP; CARPINUS BETULUS FLOWERING TOP; CASTANEA SATIVA FLOWER; CENTAURIUM ERYTHRAEA FLOWER; CERATOSTIGMA WILLMOTTIANUM FLOWER; CICHORIUM INTYBUS FLOWER; FAGUS SYLVATICA FLOWERING TOP; GENTIANELLA AMARELLA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; HORSE CHESTNUT; HOTTONIA PALUSTRIS FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; IMPATIENS GLANDULIFERA FLOWER; JUGLANS REGIA FLOWERING TOP; LARIX DECIDUA FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWERING TOP; MALUS DOMESTICA FLOWER; MIMULUS GUTTATUS FLOWERING TOP; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PINUS SYLVESTRIS FLOWERING TOP; PRUNUS CERASIFERA FLOWER; QUERCUS ROBUR FLOWER; ROSA CANINA FLOWER; SALIX ALBA FLOWERING TOP; SCLERANTHUS ANNUUS FLOWERING TOP; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; ULEX EUROPAEUS FLOWER; VERBENA OFFICINALIS FLOWERING TOP; VITIS VINIFERA FLOWERING TOP 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL 64578-0107_40df290f-d006-4882-a52a-a0d7868b4fce 64578-0107 HUMAN OTC DRUG Rescue Calm Homeopathic Liquid LIQUID ORAL 20140825 UNAPPROVED HOMEOPATHIC Energetix Corp CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER 30; 30; 30; 30; 30 [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL 64578-0108_e52a3be8-2c55-42b6-89af-29df72716f9a 64578-0108 HUMAN OTC DRUG Rescue Calm Homeopathic Liquid LIQUID ORAL 20140825 UNAPPROVED HOMEOPATHIC Energetix Corp CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER 30; 30; 30; 30; 30 [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL 64578-0109_190f9068-b006-408f-9e90-123dc1442886 64578-0109 HUMAN OTC DRUG Isopathic Phenolic Rings Homeopathic Liquid LIQUID ORAL 20141120 UNAPPROVED HOMEOPATHIC Energetix Corp ACETALDEHYDE; ANHYDROUS CITRIC ACID; ARABICA COFFEE BEAN; BENZENE; BOS TAURUS HYPOTHALAMUS; BOS TAURUS TESTICLE; CAFFEINE; CANDIDA ALBICANS; CHOCOLATE; CHOLINE; CINNAMON; COUMARIN; ESTRONE; GALLIC ACID; GREEN PEPPERCORN; HISTAMINE; INDOLE; KEROSENE; ONION; PETROSELINUM CRISPUM; PHENOL; PHLORIZIN; PHOSPHORUS; SUCROSE; SUS SCROFA ADRENAL GLAND; TURPENTINE OIL; VALERIAN 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 9; 12; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0110_a487316e-6d7d-46d3-bacc-7ff6761d4ab9 64578-0110 HUMAN OTC DRUG PhytoGel Homeopathic Gel GEL TOPICAL 20140314 UNAPPROVED HOMEOPATHIC Energetix Corp ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; SODIUM SULFATE; SULFURIC ACID; TOXICODENDRON PUBESCENS LEAF 1; 12; 30; 1; 3; 30; 1; 12; 30; 12; 30 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0112_696feee6-59d4-474e-8680-37229c486bcb 64578-0112 HUMAN OTC DRUG Lymph-Tone II Homeopathic Liquid LIQUID ORAL 20140418 UNAPPROVED HOMEOPATHIC Energetix Corp AZADIRACHTA INDICA BARK; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS HYPOTHALAMUS; BUFO BUFO CUTANEOUS GLAND; COENZYME A; COLLINSONIA CANADENSIS ROOT; ECHINACEA ANGUSTIFOLIA; FERRUM PHOSPHORICUM; HORSE CHESTNUT; NADIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PEUMUS BOLDUS LEAF; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PINE TAR; PINUS SYLVESTRIS LEAFY TWIG; PULSATILLA VULGARIS; SILICON DIOXIDE; SODIUM CHLORIDE; STILLINGIA SYLVATICA ROOT; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; TRIBASIC CALCIUM PHOSPHATE; WOOD CREOSOTE 8; 12; 12; 12; 12; 12; 10; 6; 12; 12; 12; 12; 4; 30; 4; 6; 9; 12; 12; 12; 4; 9; 12; 12; 12; 15 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0113_0b7c8908-84e1-4b4f-a381-7ed975991c0b 64578-0113 HUMAN OTC DRUG CV-Tone Homeopathic Liquid LIQUID ORAL 20140613 UNAPPROVED HOMEOPATHIC Energetix Corp AMMI VISNAGA FRUIT; CONVALLARIA MAJALIS; GAMBOGE; SELENICEREUS GRANDIFLORUS STEM; TILIA X EUROPAEA FLOWER 8; 4; 6; 12; 6 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0114_faf6882b-4c0e-419e-a2a8-d885e8feaa4a 64578-0114 HUMAN OTC DRUG Drainage-Tone Homeopathic Liquid LIQUID ORAL 20140929 UNAPPROVED HOMEOPATHIC Energetix Corp CALCIUM IODIDE; CAPSICUM; COD LIVER OIL; COENZYME A; ECHINACEA ANGUSTIFOLIA; EQUISETUM ARVENSE TOP; GOLDENSEAL; NADIDE; NITRIC ACID; PETROSELINUM CRISPUM; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; WHITE MUSTARD SEED 12; 6; 15; 8; 4; 6; 4; 8; 12; 4; 4; 4; 12; 4; 4 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64578-0115_06537274-8a3e-460a-bf3a-1ce824967dde 64578-0115 HUMAN OTC DRUG Endopath-F Homeopathic Liquid LIQUID ORAL 20141111 UNAPPROVED HOMEOPATHIC Energetix Corp ANGELICA SINENSIS ROOT; BLACK COHOSH; BOS TAURUS HYPOTHALAMUS; CHASTE TREE; FUCUS VESICULOSUS; GLYCYRRHIZA GLABRA; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED; ZANTHOXYLUM AMERICANUM BARK 8; 4; 12; 4; 4; 4; 12; 12; 9; 9; 12; 9; 4 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 64581-072_0b83aec3-ea71-4ec2-a6c2-fb429d993dad 64581-072 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990501 UNAPPROVED MEDICAL GAS Milner Rushing Home Care OXYGEN 99 L/100L 64582-0001_69a81e62-78c0-4815-b1be-ba6c39305822 64582-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980420 UNAPPROVED MEDICAL GAS A & D Healthcare (Equipment Repair) OXYGEN 99 L/100L 64588-0001_a2016ba9-708d-4fea-a47f-a0ddb9ce260a 64588-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19981003 UNAPPROVED MEDICAL GAS Corner Homecare OXYGEN 99 L/100L 64597-301_227f068c-e569-4bb1-90e6-39196b27ea38 64597-301 HUMAN PRESCRIPTION DRUG NUEDEXTA dextromethorphan hydrobromide and quinidine sulfate CAPSULE, GELATIN COATED ORAL 20101201 NDA NDA021879 Avanir Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE 20; 10 mg/1; mg/1 Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] 64606-100_131e808b-418f-8dfc-59b5-a05dfa88474a 64606-100 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Norton Sound Health Corporation OXYGEN 93 mL/L 64613-0456_908ed8cd-cc36-4f79-a098-96b395708b0f 64613-0456 HUMAN OTC DRUG Sal de Uvas Picot Antacid POWDER, FOR SOLUTION ORAL 20110303 OTC MONOGRAPH FINAL part331 Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. CITRIC ACID; SODIUM BICARBONATE 1.948; 2.485 g/1; g/1 64613-0456_bef8492b-21ca-4610-a652-2ede7cbf8fb4 64613-0456 HUMAN OTC DRUG Sal de Uvas Picot Antacid POWDER, FOR SOLUTION ORAL 20110111 OTC MONOGRAPH FINAL part331 Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. CITRIC ACID; SODIUM BICARBONATE 1.948; 2.485 g/1; g/1 64613-0456_e584017b-907f-4657-81c7-6dd0a896f981 64613-0456 HUMAN OTC DRUG Sal de Uvas Picot Antacid POWDER, FOR SOLUTION ORAL 20110303 OTC MONOGRAPH FINAL part331 Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. CITRIC ACID; SODIUM BICARBONATE 1.948; 2.485 g/1; g/1 64613-5600_7c9552a7-f15b-42ab-a545-106aa51af1a4 64613-5600 HUMAN OTC DRUG Picot Plus Effervescent Antacid and Pain Reliever POWDER ORAL 20100528 OTC MONOGRAPH FINAL part331 Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. ASPIRIN; CITRIC ACID; SODIUM BICARBONATE 500; 1.948; 2.485 mg/1; g/1; g/1 64613-5700_40af2c4f-4c89-4d6b-a736-565bd6078901 64613-5700 HUMAN OTC DRUG Tempra Acetaminophen TABLET ORAL 20110309 OTC MONOGRAPH NOT FINAL part343 Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. ACETAMINOPHEN 500 mg/1 64613-5800_d542a0fa-d9eb-4741-9369-019a4e837232 64613-5800 HUMAN OTC DRUG Tempra Acetaminophen SYRUP ORAL 20110510 OTC MONOGRAPH NOT FINAL part343 Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. ACETAMINOPHEN 160 mg/5mL 64613-5900_c3f174ce-b129-450d-9420-c6bee2e495e4 64613-5900 HUMAN OTC DRUG Tempra Acetaminophen LIQUID ORAL 20110310 OTC MONOGRAPH NOT FINAL part343 Bristol-Myers Squibb de Mexico, S. de R.L. de C. V. ACETAMINOPHEN 100 mg/mL 64616-035_8b443d6c-a68f-42f5-b662-be60f212e830 64616-035 HUMAN OTC DRUG Sinus Cleanser Sinus Relief LIQUID NASAL 20100204 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. BAPTISIA TINCTORIA ROOT 12 1/mL 64616-037_8be28928-bf45-4427-99c9-a6e5a66d0136 64616-037 HUMAN PRESCRIPTION DRUG Olive Leaf Throat Throat Spray SPRAY ORAL 20030227 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. BAPTISIA TINCTORIA 4 [hp_X]/mL 64616-038_531568f9-17db-40ff-8ff4-6c3ba301739b 64616-038 HUMAN OTC DRUG Olive Leaf Throat Flavored Throat Spray SPRAY ORAL 20030227 UNAPPROVED HOMEOPATHIC Vitality Works, Inc BAPTISIA TINCTORIA 4 [hp_X]/mL 64616-039_7f3bcac9-e0f9-4a42-b662-4802afcb0a5e 64616-039 HUMAN OTC DRUG Olive Leaf Nasal Nasal Spray SPRAY NASAL 20030107 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. BAPTISIA TINCTORIA; OLEA EUROPAEA LEAF 4; 4 [hp_X]/mL; [hp_X]/mL 64616-041_b45ae044-5c03-41e4-9c36-c3b794760841 64616-041 HUMAN OTC DRUG Cold and Infection Defense Nasal Throat Spray LIQUID NASAL 20031216 UNAPPROVED HOMEOPATHIC Vitality Works, Inc BELLADONNA LEAF; ECHINACEA PURPUREA; ECHINACEA PURPUREA ROOT 5; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-042_8f4c8b64-6521-4a78-9406-9b8f8fdc2d42 64616-042 HUMAN OTC DRUG Olive-Viate Topical Skin Relief LIQUID TOPICAL 20040302 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. CALCIUM SULFIDE; GRAPHITE; SULFUR; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-045_1933d8e5-e9ee-4578-adad-48007a841fec 64616-045 HUMAN OTC DRUG Earache Remedy Ear Drops LIQUID AURICULAR (OTIC) 20040823 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; MATRICARIA RECUTITA; PLANTAGO MAJOR; POTASSIUM CHLORIDE; VERBASCUM THAPSUS 6; 3; 6; 3; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-046_1ea29c0b-d778-4ae3-bb8a-a5431adc79ab 64616-046 HUMAN OTC DRUG Bye Bye Burns Topical Skin Spray SPRAY TOPICAL 20040823 UNAPPROVED HOMEOPATHIC Vitality Works, Inc ATROPA BELLADONNA; LYTTA VESICATORIA; RANUNCULUS BULBOSUS; URTICA DIOICA 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-047_669c0274-9ab1-4ecb-8497-fbe33875c4c4 64616-047 HUMAN OTC DRUG Bye Bye Diaper Rash Diaper Rash Treatment LIQUID TOPICAL 20051026 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. CALCIUM SULFIDE; LYTTA VESICATORIA; SULFUR; TOXICODENDRON PUBESCENS LEAF 12; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-048_a68e8fad-5878-42db-8594-826e2c459e0f 64616-048 HUMAN OTC DRUG Stop Rash Adult Skin Relief LIQUID TOPICAL 20060506 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. CALCIUM SULFIDE; LYTTA VESICATORIA; SULFUR; TOXICODENDRON PUBESCENS LEAF 12; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-050_5450b3a8-a0ad-47ac-aea9-c9dbf3efbe89 64616-050 HUMAN OTC DRUG Pediatric Earache Remedy Ear Drops LIQUID AURICULAR (OTIC) 20061023 UNAPPROVED HOMEOPATHIC Vitality Works, Inc ACONITUM NAPELLUS; ATROPA BELLADONNA; MATRICARIA RECUTITA; PLANTAGO MAJOR; POTASSIUM CHLORIDE; VERBASCUM THAPSUS 6; 3; 6; 3; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-055_29c13f44-a94b-4266-ab01-d435a1618802 64616-055 HUMAN OTC DRUG Olive Vaginal Formula Olive Leaf Vaginal Spray SPRAY VAGINAL 20100210 UNAPPROVED HOMEOPATHIC Vitality Works, Inc CHAMAELIRIUM LUTEUM ROOT; PLATINUM; SODIUM BORATE; WOOD CREOSOTE 8; 12; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-056_677b1064-a27c-4760-baa1-e8254e509e6f 64616-056 HUMAN PRESCRIPTION DRUG Olive Rectal Formula Olive Rectal Spray SPRAY RECTAL 20100607 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ACTIVATED CHARCOAL; ALOE; GAMBOGE; HORSE CHESTNUT; SULFUR 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-069_a1a9bc38-f014-43e9-b294-7c143e0fafc3 64616-069 HUMAN OTC DRUG Olive Leaf Acne Remedy Topical Skin Relief LIQUID TOPICAL 20110420 UNAPPROVED HOMEOPATHIC Vitality Works, Inc ANTIMONY TRISULFIDE; CALCIUM SULFATE ANHYDROUS; JUGLANS REGIA FLOWERING TOP; SULFUR IODIDE 12; 12; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-070_2150f94c-8a54-48c3-8d04-1e10c3cdd247 64616-070 HUMAN OTC DRUG Cut and Wound Remedy Topical Cut and Wound Relief SPRAY TOPICAL 20110718 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG 6; 1; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-072_bebee49b-03b3-4b64-a58c-7e309819d165 64616-072 HUMAN OTC DRUG Formula 3 Cough Syrup Cough Syrup LIQUID ORAL 20100707 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. PELARGONIUM SIDOIDES ROOT; PRUNUS SEROTINA BARK; SAMBUCUS NIGRA FLOWER 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-077_e04ca1f3-ff9c-4a36-bca0-66a03e331187 64616-077 HUMAN PRESCRIPTION DRUG Slenderiix Weight Management Formula LIQUID ORAL 20120516 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. AMMONIUM BROMIDE; AVENA SATIVA FLOWERING TOP; FUCUS VESICULOSUS; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFURIC ACID; THYROID, UNSPECIFIED 12; 6; 6; 12; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 64616-079_4518aa60-0a42-4e80-8218-785548b02c50 64616-079 HUMAN OTC DRUG ADR-Bal Adrenal Support LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ALETRIS FARINOSA ROOT; FENNEL SEED; SALIX NIGRA BARK; WOOD TAR HYDROCARBON DISTILLATE; WYETHIA HELENIOIDES ROOT 7; 15; 15; 15; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-080_572d1b7f-77f3-473a-8a1c-66745d8d5ba9 64616-080 HUMAN OTC DRUG Al-Inflam Joint Support LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ANAGALLIS ARVENSIS; CROTALUS HORRIDUS HORRIDUS VENOM; HAWTHORN LEAF WITH FLOWER; PASSIFLORA INCARNATA FLOWERING TOP; PLATINUM; SILVER NITRATE; URTICA URENS 10; 20; 20; 15; 12; 15; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-081_2ddd0d8a-7f63-404d-a6e5-ee3f5b2df2f0 64616-081 HUMAN OTC DRUG Brain Supp Brain Support LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ARISAEMA TRIPHYLLUM ROOT; CHOLESTEROL; CINCHONA OFFICINALIS BARK; EGG PHOSPHOLIPIDS; GARLIC; GOLDENSEAL; IRON; LATHYRUS SATIVAS SEED; PHOSPHORUS; SANTONIN; SUS SCROFA PITUITARY GLAND; VALERIAN 6; 10; 30; 8; 6; 6; 10; 10; 12; 10; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 64616-082_d110f06b-db9a-472e-acb2-2ac515cf8692 64616-082 HUMAN OTC DRUG Category I Immune System Booster LIQUID ORAL 20130320 UNAPPROVED HOMEOPATHIC Vitality Works, Inc ACTAEA SPICATA ROOT; ANAGALLIS ARVENSIS; ARGEMONE MEXICANA; CANDIDA ALBICANS; HELODERMA HORRIDUM VENOM; HYOSCYAMUS NIGER; POTASSIUM DICHROMATE; POTASSIUM IODIDE; POTASSIUM NITRATE; POTASSIUM PHOSPHATE, DIBASIC; SENNA LEAF; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 6; 15; 17; 14; 5; 10; 10; 10; 10; 7; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-083_f82fed9a-3a7e-40ae-af4d-22f901323cef 64616-083 HUMAN OTC DRUG Category II Immune System Booster LIQUID ORAL 20130320 UNAPPROVED HOMEOPATHIC Vitality Works, Inc ARALIA RACEMOSA ROOT; ARUNDO PLINIANA ROOT; CHASTE TREE; ERIODICTYON CALIFORNICUM LEAF; EUPHORBIA RESINIFERA RESIN; GAMBOGE; LEAD; LYCOSA TARANTULA; MERCURIC CHLORIDE; MERCURIC CYANIDE; MERCURIC IODIDE; MERCURY; PAEONIA OFFICINALIS ROOT; PINE TAR; SELENIUM; THYROID, UNSPECIFIED; TRILLIUM ERECTUM ROOT 6; 6; 3; 3; 14; 7; 10; 15; 10; 15; 10; 10; 15; 10; 15; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 64616-084_d1c07798-53e3-4bef-b5cb-3224fce5dd8d 64616-084 HUMAN OTC DRUG Category III Immune System Booster LIQUID ORAL 20130313 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ACTIVATED CHARCOAL; ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; CHIONANTHUS VIRGINICUS BARK; CORALLIUM RUBRUM EXOSKELETON; EGG PHOSPHOLIPIDS; GOLD; MORELLA CERIFERA ROOT BARK; ORNITHOGALUM UMBELLATUM; PETROSELINUM CRISPUM; SANGUINARIA CANADENSIS ROOT 12; 10; 10; 9; 7; 15; 15; 10; 7; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-085_2b679473-3fd3-4520-a5eb-0d9f39c6e098 64616-085 HUMAN OTC DRUG Category IV Immune System Booster LIQUID ORAL 20130320 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ACTAEA SPICATA ROOT; ALOE; COPPER; CUPRIC ARSENITE; FRAXINUS AMERICANA BARK; LYTTA VESICATORIA; SKIM MILK; SOLANUM DULCAMARA TOP; URTICA URENS; ZINC 6; 7; 10; 15; 8; 7; 20; 5; 5; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-086_3e148477-ff5e-4a94-8573-e84c5ccdc81d 64616-086 HUMAN OTC DRUG Category V Immune System Booster LIQUID ORAL 20130320 UNAPPROVED HOMEOPATHIC Vitality Works, Inc, ANAGALLIS ARVENSIS; ANHYDROUS CITRIC ACID; AQUA REGIA; ARSENIC TRIIODIDE; CALCIUM LACTATE; CHAMAEMELUM NOBILE; COPPER; DELPHINIUM STAPHISAGRIA SEED; EPINEPHRINE; FRAXINUS AMERICANA BARK; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; LACTIC ACID; PETROSELINUM CRISPUM; PICRIC ACID; POTASSIUM CARBONATE; SALICYLIC ACID; SALIX NIGRA BARK; STRYCHNOS IGNATII SEED; URANYL NITRATE HEXAHYDRATE 3; 15; 15; 10; 50; 20; 25; 5; 15; 4; 14; 15; 20; 12; 8; 12; 20; 4; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-087_d74a6a8f-ec55-46a4-921f-110c7703f0bb 64616-087 HUMAN OTC DRUG CL-N Emotional Health Booster LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ACONITUM NAPELLUS; AMBERGRIS; AMMI VISNAGA FRUIT; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; BLACK MUSTARD SEED; CAUSTICUM; CHELIDONIUM MAJUS; CLEMATIS RECTA FLOWERING TOP; EUPATORIUM PERFOLIATUM FLOWERING TOP; FENNEL SEED; FERRUM PHOSPHORICUM; FRAXINUS AMERICANA BARK; LILIUM LANCIFOLIUM WHOLE FLOWERING; MARSDENIA CONDURANGO BARK; MATRICARIA RECUTITA; MERCURIC CHLORIDE; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; SCROPHULARIA NODOSA; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 6; 12; 10; 15; 6; 12; 12; 15; 10; 10; 7; 5; 3; 30; 12; 12; 10; 10; 5; 17; 7; 15; 7; 10; 15; 7; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-088_f3c28f54-28bb-4b23-aca6-fc7f6cb22c3a 64616-088 HUMAN OTC DRUG ENC Emotional Health Booster LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ANGUILLA ROSTRATA BLOOD SERUM; CHASTE TREE; HORSE CHESTNUT; IRIS VERSICOLOR ROOT; MANGANESE ACETATE TETRAHYDRATE; MERCURIC CYANIDE; ORNITHOGALUM UMBELLATUM; SELENIUM; THYROID, UNSPECIFIED; ZINC 8; 10; 10; 10; 14; 14; 20; 30; 6; 20 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 64616-089_2877f150-6a54-4856-b196-a9ccc0bf3708 64616-089 HUMAN OTC DRUG Epl-Cell Repair Cell Repair Aid LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ARTEMISIA VULGARIS ROOT; ASAFETIDA; BENZENE; CALCIUM CHLORIDE; CALCIUM PICRATE; CHAMAELIRIUM LUTEUM ROOT; FUCUS VESICULOSUS; FUMARIA OFFICINALIS FLOWERING TOP; JACOBAEA MARITIMA; NITROGLYCERIN; PROTORTONIA CACTI; SEMECARPUS ANACARDIUM JUICE; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM; VIBURNUM OPULUS BARK 7; 7; 20; 10; 10; 7; 7; 8; 7; 15; 10; 7; 6; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-090_58450f06-b9ae-4641-b09a-68767e5431d8 64616-090 HUMAN PRESCRIPTION DRUG Fem Repair Non-Preg Fem Glandular and Tissue Aid LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ANTIMONY ARSENATE; CENTELLA ASIATICA; CHIONANTHUS VIRGINICUS BARK; CHRYSOPOGON ZIZANIOIDES ROOT; CLAVICEPS PURPUREA SCLEROTIUM; DAPHNE MEZEREUM BARK; GENTIANA LUTEA ROOT; MERCURIUS SOLUBILIS; OXALIC ACID DIHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; RUTA GRAVEOLENS FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA PITUITARY GLAND; VALERIANA OFFICINALIS WHOLE; ZINC OXIDE 14; 6; 6; 6; 7; 15; 6; 12; 10; 20; 6; 20; 6; 6; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 64616-091_463aa099-66f8-4d06-bbf4-9c664ccf40b5 64616-091 HUMAN OTC DRUG Fem Response Female Reproductive Booster LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. APOCYNUM CANNABINUM ROOT; ARALIA RACEMOSA ROOT; BELLIS PERENNIS; CUPRIC ARSENITE; JUNIPERUS SABINA LEAFY TWIG; LACTIC ACID, DL-; PAPAYA SEED; WYETHIA HELENIOIDES ROOT 7; 30; 20; 10; 20; 10; 8; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 64616-092_2e5f47b9-61df-442b-aae8-c000b4920249 64616-092 HUMAN OTC DRUG GDS-Calm Digestive Balance LIQUID ORAL 20130417 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ASPIDOSPERMA QUEBRACHO-BLANCO BARK; CANDIDA ALBICANS; CHAMAEMELUM NOBILE; CHRYSOPOGON ZIZANIOIDES ROOT; HELIANTHEMUM CANADENSE; HORSE CHESTNUT; LILIUM LANCIFOLIUM WHOLE FLOWERING; ROBINIA PSEUDOACACIA BARK; SYZYGIUM JAMBOS SEED; VIROLA SEBIFERA RESIN 6; 14; 14; 7; 8; 7; 15; 7; 7; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-093_62759ed1-59b7-41c3-ab46-69fa87ff8307 64616-093 HUMAN OTC DRUG HCB-Res Heart,Circulatory System and Blood Booster LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. GALIUM APARINE; HELODERMA HORRIDUM VENOM; KALMIA LATIFOLIA LEAF; KEROSENE; MARSDENIA CONDURANGO BARK; MILK THISTLE; SALIX NIGRA BARK; SEMECARPUS ANACARDIUM JUICE; VERATRUM VIRIDE ROOT; VERBENA OFFICINALIS 7; 15; 10; 15; 3; 7; 10; 5; 10; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-094_3822f0b2-7ff8-4d46-9c05-e7a289da2560 64616-094 HUMAN OTC DRUG HCB-Tone Heart Muscle Aid LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. CAMPHOR (NATURAL); GALIUM APARINE; HELODERMA HORRIDUM VENOM; KEROSENE; MARSDENIA CONDURANGO BARK; PAPAYA SEED; SALIX NIGRA BARK; SEMECARPUS ANACARDIUM JUICE; VERATRUM VIRIDE ROOT; VERBENA OFFICINALIS 9; 10; 15; 15; 4; 8; 10; 6; 10; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-095_53764239-47ee-4040-a85c-ec066b9f1f35 64616-095 HUMAN OTC DRUG L-Trans Lymph System Booster LIQUID ORAL 20130320 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ARNICA MONTANA; ARSENIC TRIIODIDE; BAPTISIA TINCTORIA; BENZENE; CAPSELLA BURSA-PASTORIS; COBALT; CRATAEGUS FRUIT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FRAXINUS AMERICANA BARK; HYOSCYAMUS NIGER; LEDUM PALUSTRE TWIG; NICOTINE; SARSAPARILLA; SILVER; SYZYGIUM JAMBOS SEED; TEUCRIUM MARUM; TURPENTINE OIL; VERONICASTRUM VIRGINICUM ROOT; VIBURNUM OPULUS BARK 8; 14; 10; 12; 10; 14; 10; 10; 7; 7; 10; 12; 10; 14; 7; 6; 20; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-096_44313279-f37a-4fbb-ab48-54f18210bfde 64616-096 HUMAN OTC DRUG Lung-Resp Cough Relief LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc ARSENIC TRIOXIDE; BROMINE; GERANIUM MACULATUM ROOT; IPECAC; LACTUCA VIROSA; LYCOPERDON UTRIFORME FRUITING BODY; MYRTUS COMMUNIS TOP; SALIX NIGRA BARK; WYETHIA HELENIOIDES ROOT 15; 10; 12; 15; 20; 10; 20; 10; 20 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-097_f03e604f-1bd4-4488-81fb-ffae78a9b0e6 64616-097 HUMAN OTC DRUG LV-FX Liver Assit LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc ANACARDIUM OCCIDENTALE FRUIT; ARALIA RACEMOSA ROOT; ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; BELLIS PERENNIS; CALCIUM FLUORIDE; CHAMAELIRIUM LUTEUM ROOT; FERULA SUMBUL ROOT; HORSE CHESTNUT; LEDUM PALUSTRE TWIG; MANGANESE ACETATE TETRAHYDRATE; MILK THISTLE; MYRTUS COMMUNIS TOP; PHYSALIS ALKEKENGI FRUIT; RUTA GRAVEOLENS FLOWERING TOP; SELENIUM; SIMABA CEDRON SEED; THYROID, UNSPECIFIED; VERATRUM VIRIDE ROOT 14; 10; 15; 15; 7; 20; 10; 14; 10; 20; 20; 15; 6; 7; 10; 30; 9; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 64616-098_f44ce0e1-de75-48e2-8ad6-0d33c6d5c88c 64616-098 HUMAN OTC DRUG MALE-PROS Prostrate Booster LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ACTAEA SPICATA ROOT; ANTIMONY TRISULFIDE; ARNICA MONTANA; CHELIDONIUM MAJUS; CLEMATIS RECTA FLOWERING TOP; CYPRIPEDIUM PARVIFOLUM ROOT; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; KEROSENE; LEDUM PALUSTRE TWIG; MERCURIC CYANIDE; MERCURIUS SOLUBILIS; OCIMUM AMERICANUM LEAF; PSEUDOGNAPHALIUM OBTUSIFOLIUM; SILVER NITRATE; VERATRUM ALBUM ROOT; ZINC OXIDE 10; 9; 7; 6; 15; 14; 20; 10; 7; 14; 12; 15; 70; 15; 6; 6 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-099_d85eda3e-3b16-45a1-8626-db3d029411f9 64616-099 HUMAN OTC DRUG NRV-Systemic Nervouse System Aid LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ATROPINE; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; EPINEPHRINE; KRAMERIA LAPPACEA ROOT; ORNITHOGALUM UMBELLATUM; PILOCARPUS JABORANDI LEAF; POTASSIUM ARSENITE ANHYDROUS; SEMPERVIVUM TECTORUM LEAF; SILVER; SILVER IODIDE; SILVER NITRATE; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 14; 6; 8; 7; 20; 10; 10; 7; 18; 10; 10; 14; 10; 3; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-100_5619e4a9-9354-4de1-a6f9-68ffdeb7ce80 64616-100 HUMAN OTC DRUG OP-P Emotional Health Booster LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ACONITUM LYCOCTONUM; ALOE; ALUMINUM OXIDE; ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM OXALATE MONOHYDRATE; DROSERA ROTUNDIFOLIA; ECHINACEA PURPUREA; GAMBOGE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LOBELIA INFLATA; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PARAFFIN; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM CHLORIDE; PULSATILLA PRATENSIS; SCUTELLARIA LATERIFLORA; SEMECARPUS ANACARDIUM JUICE; SENNA LEAF; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SULFURIC ACID; USTILAGO MAYDIS 5; 10; 10; 8; 15; 6; 12; 15; 12; 6; 12; 10; 5; 15; 6; 10; 15; 30; 12; 27; 5; 14; 10; 6; 2; 7; 10; 10; 30; 30; 10; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-101_f49d64a8-f5f2-416c-a9ab-adc4946eb1b1 64616-101 HUMAN OTC DRUG Pan-Zyme-S Pancreas Balance LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ARNICA MONTANA ROOT; CRATAEGUS FRUIT; ETHER; LILIUM LANCIFOLIUM WHOLE FLOWERING; MANGANESE ACETATE TETRAHYDRATE; PARAFFIN; PLANTAGO MAJOR; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; THYROID, UNSPECIFIED; VALERIAN; WOOD CREOSOTE 5; 10; 10; 10; 15; 14; 10; 10; 45; 6; 12; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 64616-102_45740904-dc25-4898-be47-22fc7965e5f9 64616-102 HUMAN OTC DRUG Para-BN Parathyroid Booster LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ALFALFA; ARSENIC TRIOXIDE; CALCIUM FLUORIDE; CALCIUM HYDROXIDE; CALCIUM IODIDE; CALCIUM OXALATE MONOHYDRATE; CROTON TIGLIUM SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PODOPHYLLUM; POTASSIUM CARBONATE; SODIUM TETRACHLOROAURATE; TEUCRIUM MARUM; URANYL NITRATE HEXAHYDRATE 7; 30; 12; 20; 12; 20; 6; 10; 7; 10; 20; 10; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-103_a3910b8f-1b2c-4bb6-a60a-605faa6674ce 64616-103 HUMAN OTC DRUG Renal Supp-RDP Kidney Support LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ACHILLEA MILLEFOLIUM; AMMONIUM CHLORIDE; AMMONIUM PHOSPHATE, DIBASIC; ARISAEMA TRIPHYLLUM ROOT; ARTEMISIA VULGARIS ROOT; ASAFETIDA; BARIUM CHLORIDE DIHYDRATE; CALCIUM OXALATE MONOHYDRATE; HELLEBORUS FOETIDUS ROOT; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; JUGLANS REGIA LEAF; KALMIA LATIFOLIA LEAF; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM NITRATE; SEPIA OFFICINALIS JUICE 7; 12; 20; 15; 10; 10; 10; 25; 100; 14; 7; 30; 10; 30; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-104_9f22c56a-b838-41d7-af3c-8cb37f543d0f 64616-104 HUMAN OTC DRUG RPT-Sys Emotional Rebalance LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. APOCYNUM CANNABINUM ROOT; ASAFETIDA; EGG PHOSPHOLIPIDS; EUCALYPTUS GLOBULUS LEAF; GENTIANA LUTEA ROOT; LATHYRUS SATIVAS SEED; LYCOPODIUM CLAVATUM SPORE; NUTMEG; OXALIC ACID DIHYDRATE; PHOSPHORIC ACID; PLATINUM; SILICON DIOXIDE; SODIUM BORATE; STRYCHNOS IGNATII SEED; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF; TRILLIUM ERECTUM ROOT; WOOD CREOSOTE 10; 6; 20; 7; 7; 20; 7; 7; 10; 8; 10; 10; 7; 10; 6; 6; 10; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-105_bcbbdb01-4729-479c-b57f-5cf7d5e6d654 64616-105 HUMAN OTC DRUG Sweep Detoxifying LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ACTIVATED CHARCOAL; AMMI VISNAGA FRUIT; CARBO ANIMALIS; CITRULLUS COLOCYNTHIS FRUIT PULP; DAPHNE MEZEREUM BARK; NITRIC ACID; PALLADIUM; PLATINUM; POTASSIUM ARSENITE ANHYDROUS; QUININE ARSENATE; SELENIUM; SMILAX REGELII ROOT 10; 10; 20; 7; 10; 20; 14; 15; 20; 14; 20; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-106_63be8d72-6b61-46b8-802d-837b90d81b3f 64616-106 HUMAN OTC DRUG THY-Plex Thyroid Support LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. AQUA REGIA; BARIUM IODIDE; CALCIUM ACETATE; CALENDULA OFFICINALIS FLOWERING TOP; CHRYSOPOGON ZIZANIOIDES ROOT; GALLIC ACID MONOHYDRATE; GAMBOGE; HYOSCYAMUS NIGER; PHYSOSTIGMA VENENOSUM SEED; POTASSIUM IODIDE; SCHOENOCAULON OFFICINALE SEED; THYROID, UNSPECIFIED; URTICA URENS; ZINC OXIDE 15; 18; 10; 3; 10; 12; 5; 12; 10; 12; 10; 6; 5; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 64616-107_188bc8b3-6d20-4b4e-ad9e-c2b5fca1fde8 64616-107 HUMAN OTC DRUG TLB-Matrix Joint Booster LIQUID ORAL 20130320 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ATROPA BELLADONNA; FERRIC PICRATE; GOLD; LAMIUM ALBUM; PICEA MARIANA RESIN; PULSATILLA VULGARIS; PUNICA GRANATUM ROOT BARK; THYROID, UNSPECIFIED; URTICA URENS; VIBURNUM OPULUS BARK; ZINC OXIDE 15; 15; 15; 7; 15; 15; 10; 6; 7; 14; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-108_421d317e-f1f8-4f81-ba7b-6c4c03e80edd 64616-108 HUMAN OTC DRUG Vital-FL Body Fluid Balance LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC Vitaltiy Works, Inc. ARISAEMA TRIPHYLLUM ROOT; CALCIUM FLUORIDE; CANIS LUPUS FAMILIARIS MILK; CAPSELLA BURSA-PASTORIS; FERRIC PICRATE; GENTIANA LUTEA ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYOSCYAMUS NIGER; LACTUCA VIROSA; SODIUM CHLORIDE; SULFUR IODIDE; TEUCRIUM MARUM; VALERIAN; WOOD CREOSOTE 7; 10; 20; 7; 15; 7; 60; 5; 5; 15; 15; 7; 7; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-109_46334337-cffc-46d5-ad1c-0e16fea22643 64616-109 HUMAN OTC DRUG Cal-5-Revive Calcium Balance LIQUID ORAL 20130320 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ACONITUM NAPELLUS; BISMUTH SUBNITRATE; CALCIUM ARSENATE; CALCIUM FLUORIDE; CALCIUM HYDROXIDE; CALCIUM IODIDE; CALCIUM OXALATE MONOHYDRATE; ELAEIS GUINEENSIS FRUIT; HELIANTHUS ANNUUS FLOWERING TOP; HYDRANGEA ARBORESCENS ROOT; IPECAC; IRIS GERMANICA VAR. FLORENTINA ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; MERCURIUS SOLUBILIS; OSMIUM; PHOSPHORIC ACID; POTASSIUM ARSENITE ANHYDROUS; POTASSIUM CHLORATE; SANGUINARINE NITRATE; TELLURIUM; ZINC GLUCONATE 20; 15; 12; 25; 27; 10; 30; 20; 22; 14; 24; 23; 22; 22; 30; 22; 36; 20; 30; 17; 27; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 64616-111_d9bb7d31-9e2a-42e1-9bc6-5f12f2dad03d 64616-111 HUMAN OTC DRUG Sore Muscle and Joint Relief Muscle and Joint Remedy LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC Vitaltiy Works, Inc. ARNICA MONTANA; BRYONIA ALBA ROOT; LACTIC ACID, L-; MATRICARIA RECUTITA; POTASSIUM IODIDE; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; ZINC OXIDE 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 64650-345_dac3bce9-9e22-4309-a6a9-e0495e328299 64650-345 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19710101 UNAPPROVED MEDICAL GAS Atlantic Welding Supply OXYGEN 99 L/100L 64656-0250_a8d4ae0c-b0f2-408d-acb0-7b389e970b4f 64656-0250 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Mercy Home Care-HME OXYGEN 99 L/100L 64661-011_948034e4-281a-4391-a6c9-0f395323d8a3 64661-011 HUMAN OTC DRUG J-MAX Guaifenesin, and Phenylephrine Hydrochloride SYRUP ORAL 20060314 OTC MONOGRAPH FINAL part341 JayMac Pharmaceuticals LLC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 200; 5 mg/5mL; mg/5mL 64661-031_67e4bb2e-b777-47c4-b439-e20bef6e6269 64661-031 HUMAN OTC DRUG J-TAN PD Brompheniramine Maleate LIQUID ORAL 20070529 OTC MONOGRAPH FINAL part341 JayMac Pharmaceuticals LLC BROMPHENIRAMINE MALEATE 1 mg/mL 64661-032_665dee80-80ce-4b19-ac18-9c4977925332 64661-032 HUMAN OTC DRUG J-TAN D PD Brompheniramine Maleate and Pseudoephedrine Hydrochloride LIQUID ORAL 20070605 OTC MONOGRAPH FINAL part341 JayMac Pharmaceuticals LLC BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 7.5 mg/mL; mg/mL 64661-060_78f3c338-8e65-4261-860f-86796f41409a 64661-060 HUMAN PRESCRIPTION DRUG J-COF DHC Dihydrocodeine Bitartrate, Brompheniramine Maleate, Pseudoephedrine Hydrochloride LIQUID ORAL 20080630 UNAPPROVED DRUG OTHER JayMac Pharmaceuticals BROMPHENIRAMINE MALEATE; DIHYDROCODEINE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE 3; 7.5; 15 mg/5mL; mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] CIII 64661-070_f3354b10-fc6e-4dcb-96b4-abbc4663e425 64661-070 HUMAN PRESCRIPTION DRUG J-MAX DHC Dihydrocodeine Bitartrate, Guaifenesin LIQUID ORAL 20080630 UNAPPROVED DRUG OTHER JayMac Pharmaceuticals DIHYDROCODEINE BITARTRATE; GUAIFENESIN 7.5; 100 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 64661-090_c445c0d9-5569-461a-a5e5-063725c7a5c0 64661-090 HUMAN PRESCRIPTION DRUG DryMax Chlorpheniramine Maleate, Methscopolamine Nitrate, Pseudoephedrine Hydrochloride SYRUP ORAL 20100118 UNAPPROVED DRUG OTHER JayMac Pharmaceuticals LLC CHLORPHENIRAMINE MALEATE; METHSCOPOLAMINE NITRATE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 1.25; 30 mg/5mL; mg/5mL; mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 64661-091_7ffebcb0-c61a-431c-a34e-64d2fabbef05 64661-091 HUMAN OTC DRUG DryMax AF Chlophedianol Hydrochloride, Chlorphenirmine Maleate, Pseudoephedrine Hydrochloride SYRUP ORAL 20110923 OTC MONOGRAPH FINAL part341 JayMac Pharmaceuticals CHLOPHEDIANOL HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 25; 4; 45 mg/5mL; mg/5mL; mg/5mL 64661-092_ede5d6db-6d9a-4a09-babe-7bf54ce6fc68 64661-092 HUMAN OTC DRUG DryMax AF Chlophedianol Hydrochloride, Chlorpheniramine Maleate, Phenylephrine Hydrochloride TABLET ORAL 20130219 OTC MONOGRAPH FINAL part341 JayMac Pharmaceuticals CHLOPHEDIANOL HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 25; 4; 15 mg/1; mg/1; mg/1 64661-711_3a253926-f297-4561-8ef5-403afdeddf42 64661-711 HUMAN PRESCRIPTION DRUG EnLyte leucovorin, folic acid, levomefolate magnesium, ferrous cysteine glycinate, 1,2-docosahexanoyl-sn-glycero-3-phosphoserine calcium, 1,2-icosapentoyl-sn-glycero-3-phosphoserine calcium, phosphatidyl serine, pyridoxal 5-phosphate, flavin adenine dinucleotide, nadh, cobamamide, cocarboxylase (thiamine pyrophosphate), magnesium ascorbate, zinc ascorbate, magnesium l-threonate and betaine CAPSULE, DELAYED RELEASE PELLETS ORAL 20111001 UNAPPROVED DRUG OTHER Jaymac Pharmaceuticals LLC 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM; 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM; BETAINE; CITRIC ACID MONOHYDRATE; COBAMAMIDE; COCARBOXYLASE; FERROUS CYSTEINE GLYCINATE; FLAVIN ADENINE DINUCLEOTIDE; FOLIC ACID; LEUCOVORIN; LEVOMEFOLATE MAGNESIUM; MAGNESIUM ASCORBATE; MAGNESIUM L-THREONATE; NADH; PHOSPHATIDYL SERINE; PYRIDOXAL 5-PHOSPHATE; SODIUM CITRATE; ZINC ASCORBATE 6.4; 800; 500; 1.83; 50; 25; 13.6; 25; 1; 2.5; 7; 24; 1; 25; 12; 25; 3.67; 1 mg/1; ug/1; ug/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Methylating Activity [MoA],Methylating Agent [EPC],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 64661-811_b55156d3-2850-423a-ab3e-f6db662afbdc 64661-811 HUMAN PRESCRIPTION DRUG Viva CT Prenatal FOLIC ACID, FERROUS FUMARATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, ZINC OXIDE, CUPRIC SULFATE ANHYDROUS, and Selenomethionine TABLET, CHEWABLE ORAL 20120501 UNAPPROVED DRUG OTHER JayMac Pharmaceuticals LLC .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE ANHYDROUS; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENOMETHIONINE; THIAMINE MONONITRATE; ZINC OXIDE 30; 100; 400; 1; 15; 28; 1; 50; 3; 50; 3; 20 [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 64661-814_6c7d859f-7247-46bf-877c-d98b77e22f50 64661-814 HUMAN PRESCRIPTION DRUG Jay-Phyl Dyphylline and Guaifenesin SYRUP ORAL 20060502 UNAPPROVED DRUG OTHER JayMac Pharmaceuticals LLC DYPHYLLINE; GUAIFENESIN 100; 50 mg/5mL; mg/5mL 64678-211_462c00a5-9512-44bb-9850-948a607f796a 64678-211 VACCINE BioThrax BACILLUS ANTHRACIS INJECTION, SUSPENSION INTRAMUSCULAR 19701104 BLA BLA103821 Emergent BioDefense Operations Lansing, LLC BACILLUS ANTHRACIS STRAIN V770-NP1-R ANTIGENS 100 ug/mL Live Attenuated Bacillus Anthracis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Anthrax Vaccines [Chemical/Ingredient] 64679-101_6bb2f0b6-9828-4827-b9ec-219134771e00 64679-101 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (SR) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120515 ANDA ANDA201331 Wockhardt USA LLC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 64679-102_a427c8de-09f9-4c58-9bb1-c3d6ed34e3a8 64679-102 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121121 ANDA ANDA202189 Wockhardt USA LLC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 64679-105_6bb2f0b6-9828-4827-b9ec-219134771e00 64679-105 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (SR) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120515 ANDA ANDA201331 Wockhardt USA LLC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 64679-107_6bb2f0b6-9828-4827-b9ec-219134771e00 64679-107 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (SR) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120515 ANDA ANDA201331 Wockhardt USA LLC. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 64679-140_97b8df43-8933-4052-aaba-2f26c85334da 64679-140 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202727 Wockhardt USA LLC. LANSOPRAZOLE 15 mg/1 64679-152_21696bbf-716e-4d8c-8cf8-bb8ca7e2577b 64679-152 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED ORAL 20100524 ANDA ANDA090216 Wockhardt USA LLC. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 64679-153_21696bbf-716e-4d8c-8cf8-bb8ca7e2577b 64679-153 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED ORAL 20100524 ANDA ANDA090216 Wockhardt USA LLC. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 64679-154_13b3bc1e-f488-4bf9-abd7-8904e0ff8a50 64679-154 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64679-155_13b3bc1e-f488-4bf9-abd7-8904e0ff8a50 64679-155 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64679-171_13b3bc1e-f488-4bf9-abd7-8904e0ff8a50 64679-171 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64679-172_13b3bc1e-f488-4bf9-abd7-8904e0ff8a50 64679-172 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64679-174_13b3bc1e-f488-4bf9-abd7-8904e0ff8a50 64679-174 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64679-175_13b3bc1e-f488-4bf9-abd7-8904e0ff8a50 64679-175 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64679-177_13b3bc1e-f488-4bf9-abd7-8904e0ff8a50 64679-177 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64679-185_c193a124-ecc2-41b9-a77f-bbd986fabfb4 64679-185 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION INTRAVENOUS 20130302 ANDA ANDA203070 Wockhardt USA LLC. ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 64679-186_c907d0ec-5b8c-4cdf-a1e1-7defbe385f2f 64679-186 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION INTRAVENOUS 20130302 ANDA ANDA203069 Wockhardt USA LLC. ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 64679-209_0fe68d55-9607-4271-95de-395b13eabeb4 64679-209 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20080104 ANDA ANDA077533 Wockhardt USA, LLC TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 64679-215_9f34c515-41b7-44f5-9aa6-8f4b281337a0 64679-215 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20120815 ANDA ANDA201948 Wockhardt USA LLC. DICLOFENAC SODIUM; MISOPROSTOL 50; .2 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 64679-217_9f34c515-41b7-44f5-9aa6-8f4b281337a0 64679-217 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20120815 ANDA ANDA201948 Wockhardt USA LLC. DICLOFENAC SODIUM; MISOPROSTOL 75; .2 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 64679-271_e01b63d4-799e-4ab2-931b-f8530f6845c2 64679-271 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt USA LLC. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64679-272_e01b63d4-799e-4ab2-931b-f8530f6845c2 64679-272 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt USA LLC. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64679-273_e01b63d4-799e-4ab2-931b-f8530f6845c2 64679-273 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt USA LLC. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64679-274_e01b63d4-799e-4ab2-931b-f8530f6845c2 64679-274 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt USA LLC. LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64679-275_e01b63d4-799e-4ab2-931b-f8530f6845c2 64679-275 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt USA LLC. LAMOTRIGINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64679-290_d0c44896-c07c-401d-a4df-cb00b9e3b89b 64679-290 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20120930 NDA AUTHORIZED GENERIC NDA020796 Wockhardt USA LLC. ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 64679-311_c5a39598-5e50-4b1d-8300-623d73cb9bda 64679-311 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA091267 Wockhardt USA LLC. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 64679-312_c5a39598-5e50-4b1d-8300-623d73cb9bda 64679-312 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA091267 Wockhardt USA LLC. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 64679-314_d5efb289-8aab-4e06-8610-bda7e2342a00 64679-314 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120522 ANDA ANDA202266 Wockhardt USA LLC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 64679-315_d5efb289-8aab-4e06-8610-bda7e2342a00 64679-315 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20121113 ANDA ANDA202266 Wockhardt USA LLC. CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 64679-374_f9f5f626-1511-46eb-8d4d-584e1101f195 64679-374 HUMAN OTC DRUG FAMOTIDINE FAMOTIDINE TABLET ORAL 20100806 ANDA ANDA090837 WOCKHARDT USA LLC. FAMOTIDINE 20 mg/1 64679-411_fec86421-10b5-4c1f-a9bc-06f9fac063a1 64679-411 HUMAN PRESCRIPTION DRUG FELODIPINE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101205 ANDA ANDA091484 WOCKHARDT USA LLC FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 64679-412_fec86421-10b5-4c1f-a9bc-06f9fac063a1 64679-412 HUMAN PRESCRIPTION DRUG FELODIPINE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101205 ANDA ANDA091484 WOCKHARDT USA LLC FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 64679-414_fec86421-10b5-4c1f-a9bc-06f9fac063a1 64679-414 HUMAN PRESCRIPTION DRUG FELODIPINE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101205 ANDA ANDA091484 WOCKHARDT USA LLC FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 64679-421_d1e03e58-f5cb-48a9-b5c3-d991e9763d22 64679-421 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070906 ANDA ANDA078500 WOCKHARDT USA LLC. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 64679-422_d1e03e58-f5cb-48a9-b5c3-d991e9763d22 64679-422 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070906 ANDA ANDA078500 WOCKHARDT USA LLC. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 64679-423_d1e03e58-f5cb-48a9-b5c3-d991e9763d22 64679-423 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070906 ANDA ANDA078500 WOCKHARDT USA LLC. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 64679-433_ca214cd1-f75b-4683-9a5a-c2f969c436c1 64679-433 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA091231 WOCKHARDT USA LLC. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 64679-434_ca214cd1-f75b-4683-9a5a-c2f969c436c1 64679-434 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA091231 WOCKHARDT USA LLC. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 64679-447_ff2b85cf-b092-4e19-b7a4-edc270d24050 64679-447 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE HYDROCHLORIDE TABLET ORAL 20091211 ANDA ANDA078701 WOCKHARDT USA LLC. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 64679-516_dc32329d-66b0-4f3c-a55a-f954d605dcfc 64679-516 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100427 ANDA ANDA078938 WOCKHARDT USA LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 64679-544_fff32af6-b306-416c-a119-e2bb9af1a29d 64679-544 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Wockhardt USA LLC. LEVOFLOXACIN 250 mg/1 64679-545_fff32af6-b306-416c-a119-e2bb9af1a29d 64679-545 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Wockhardt USA LLC. LEVOFLOXACIN 500 mg/1 64679-547_fff32af6-b306-416c-a119-e2bb9af1a29d 64679-547 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Wockhardt USA LLC. LEVOFLOXACIN 750 mg/1 64679-553_a7406404-0ed8-46ee-8beb-f9059d7285c2 64679-553 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT USA LLC RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 64679-554_a7406404-0ed8-46ee-8beb-f9059d7285c2 64679-554 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT USA LLC RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 64679-555_a7406404-0ed8-46ee-8beb-f9059d7285c2 64679-555 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT USA LLC RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 64679-557_a7406404-0ed8-46ee-8beb-f9059d7285c2 64679-557 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT USA LLC RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 64679-571_a7406404-0ed8-46ee-8beb-f9059d7285c2 64679-571 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT USA LLC RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 64679-572_a7406404-0ed8-46ee-8beb-f9059d7285c2 64679-572 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT USA LLC RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 64679-630_1d76032e-0273-405b-be46-a277d84cda79 64679-630 HUMAN PRESCRIPTION DRUG ADENOSINE ADENOSINE INJECTION INTRAVENOUS 20130330 ANDA ANDA079147 Wockhardt USA LLC. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 64679-630_c228eecc-e21a-48e4-b775-d0ee282b3346 64679-630 HUMAN PRESCRIPTION DRUG ADENOSINE ADENOSINE INJECTION INTRAVENOUS 20090720 ANDA ANDA090220 WOCKHARDT USA LLC. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 64679-631_a7486c1a-6992-4f2a-8d45-0c7618b43164 64679-631 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION INTRAVENOUS 20091109 ANDA ANDA090671 Wockhardt USA LLC. NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 64679-632_ef0b005f-898a-4944-a983-72fe170ab7c7 64679-632 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090986 Wockhardt USA LLC. OCTREOTIDE ACETATE 1000 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 64679-633_ef0b005f-898a-4944-a983-72fe170ab7c7 64679-633 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090985 Wockhardt USA LLC. OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 64679-634_ef0b005f-898a-4944-a983-72fe170ab7c7 64679-634 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090986 Wockhardt USA LLC. OCTREOTIDE ACETATE 200 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 64679-635_ef0b005f-898a-4944-a983-72fe170ab7c7 64679-635 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090985 Wockhardt USA LLC. OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 64679-636_ef0b005f-898a-4944-a983-72fe170ab7c7 64679-636 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090985 Wockhardt USA LLC. OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 64679-661_ef122c23-5023-4f3c-84c4-ad03b30ef012 64679-661 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20080630 ANDA ANDA078564 WOCKHARDT USA LLC GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 64679-661_f7758fea-faf1-4d2e-8de7-09e85105bdc7 64679-661 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20080630 ANDA ANDA078565 WOCKHARDT USA LLC GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 64679-662_a8de7603-05f3-45f5-bcb9-51fbcf3f6bbd 64679-662 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20080303 ANDA ANDA078566 WOCKHARDT USA LLC GRANISETRON HYDROCHLORIDE .1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 64679-669_9d954984-4d41-4f29-b5ac-6bcc226bfe9b 64679-669 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120810 ANDA ANDA202176 Wockhardt USA LLC. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 64679-670_9d954984-4d41-4f29-b5ac-6bcc226bfe9b 64679-670 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120810 ANDA ANDA202176 Wockhardt USA LLC. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 64679-692_c5df6afa-72eb-48f9-8a85-8b82644be291 64679-692 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE SOLUTION ORAL 20091014 ANDA ANDA078744 WOCKHARDT USA LLC. RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] 64679-693_bd58a720-81d5-4358-a8d5-a835c600b60d 64679-693 HUMAN PRESCRIPTION DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE SYRUP ORAL 20090828 ANDA ANDA078757 WOCKHARDT LLC. CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 64679-694_d0dd386e-ee0f-4f52-b9cb-8fa709d14b0d 64679-694 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE HYDROCHLORIDE SYRUP ORAL 20090526 ANDA ANDA079211 WOCKHARDT USA LLC RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 64679-701_07a878ec-fc77-43fb-8b69-ecbd8307670a 64679-701 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070412 ANDA ANDA065391 Wockhardt USA LLC. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 64679-702_07a878ec-fc77-43fb-8b69-ecbd8307670a 64679-702 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070412 ANDA ANDA065391 Wockhardt USA LLC. CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 64679-703_07a878ec-fc77-43fb-8b69-ecbd8307670a 64679-703 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070412 ANDA ANDA065391 Wockhardt USA LLC. CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 64679-711_e3bb1273-05af-4291-92e1-3b5e15575b4e 64679-711 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20120816 ANDA ANDA078941 Wockhardt USA LLC. ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 64679-712_e7360217-c01d-4788-9d48-4dd5c96aad6f 64679-712 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET, FILM COATED ORAL 20070615 ANDA ANDA065428 Wockhardt USA LLC. CEFPROZIL 250 mg/1 64679-713_e7360217-c01d-4788-9d48-4dd5c96aad6f 64679-713 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET, FILM COATED ORAL 20070615 ANDA ANDA065428 Wockhardt USA LLC. CEFPROZIL 500 mg/1 64679-714_a433a237-87e5-4100-89be-eae25f1b6e9e 64679-714 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070515 ANDA ANDA078426 Wockhardt USA LLC. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 64679-715_a433a237-87e5-4100-89be-eae25f1b6e9e 64679-715 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070515 ANDA ANDA078426 Wockhardt USA LLC. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 64679-716_b7d5e7b0-6edb-4c92-a8f4-6c3e0df89e03 64679-716 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110414 ANDA ANDA078865 Wockhardt USA LLC. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64679-717_b7d5e7b0-6edb-4c92-a8f4-6c3e0df89e03 64679-717 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110414 ANDA ANDA078865 Wockhardt USA LLC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64679-718_b7d5e7b0-6edb-4c92-a8f4-6c3e0df89e03 64679-718 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110414 ANDA ANDA078865 Wockhardt USA LLC. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64679-720_60429f3c-8f6c-4331-b804-f138d2449cde 64679-720 HUMAN PRESCRIPTION DRUG EXTENDED PHENYTOIN SODIUM EXTENDED PHENYTOIN SODIUM CAPSULE ORAL 20080130 ANDA ANDA040732 Wockhardt USA LLC. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64679-724_f740b0cf-afb6-4f03-ae0c-dbbb630b47ad 64679-724 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM ER DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090210 ANDA ANDA078705 WOCKHARDT USA LLC DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64679-725_f740b0cf-afb6-4f03-ae0c-dbbb630b47ad 64679-725 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM ER DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA078705 WOCKHARDT USA LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64679-726_fffa2724-0695-47c0-8b46-ebd5e37efa82 64679-726 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20061227 ANDA ANDA077716 WOCKHARDT USA LLC ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 64679-727_fffa2724-0695-47c0-8b46-ebd5e37efa82 64679-727 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20061227 ANDA ANDA077577 WOCKHARDT USA LLC ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 64679-728_f29cd5c4-eaa1-47e6-a1b0-7781cb04c004 64679-728 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate INJECTION SUBCUTANEOUS 20090206 ANDA ANDA078593 Wockhardt USA LLC. SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 64679-734_e873cbac-1591-42e4-9868-775bcb70286e 64679-734 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Wockhardt USA LLC. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 64679-735_e873cbac-1591-42e4-9868-775bcb70286e 64679-735 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Wockhardt USA LLC. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 64679-736_e873cbac-1591-42e4-9868-775bcb70286e 64679-736 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Wockhardt USA LLC. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 64679-737_e873cbac-1591-42e4-9868-775bcb70286e 64679-737 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Wockhardt USA LLC. METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 64679-738_e0944230-c4bb-421f-a69a-b31d74db076d 64679-738 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET ORAL 20120815 ANDA ANDA090221 Wockhardt USA LLC. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 64679-740_abe01bba-a7b9-4bcc-9393-e59b3dbd3e03 64679-740 HUMAN OTC DRUG RANITIDINE RANITIDINE TABLET, COATED ORAL 20080731 ANDA ANDA078884 WOCKHARDT USA LLC. RANITIDINE HYDROCHLORIDE 75 mg/1 64679-741_d1979a8e-c659-4cf6-ae3a-f4c0065b181c 64679-741 HUMAN OTC DRUG RANITIDINE RANITIDINE TABLET, COATED ORAL 20071126 ANDA ANDA078653 WOCKHARDT USA LLC. RANITIDINE HYDROCHLORIDE 150 mg/1 64679-742_ff2b85cf-b092-4e19-b7a4-edc270d24050 64679-742 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE HYDROCHLORIDE TABLET ORAL 20091211 ANDA ANDA078701 WOCKHARDT USA LLC. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 64679-743_65b2f645-536b-45a0-97c0-f7cf056cec44 64679-743 HUMAN PRESCRIPTION DRUG TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE TABLET ORAL 20070702 ANDA ANDA078229 Wockhardt USA LLC. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 64679-744_3cc961b2-83fe-46d6-ba69-6f7e09927c09 64679-744 HUMAN OTC DRUG Fexofenadine Fexofenadine TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt USA LLC. FEXOFENADINE HYDROCHLORIDE 30 mg/1 64679-744_e8a55782-2ebf-4821-a954-928815fd80e9 64679-744 HUMAN OTC DRUG Fexofenadine Fexofenadine TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt USA LLC. FEXOFENADINE HYDROCHLORIDE 30 mg/1 64679-757_c805a4f2-c176-420c-80db-06415bf0b289 64679-757 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR; INTRAVENOUS 20070327 ANDA ANDA077942 WOCKHARDT USA LLC KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 64679-758_c805a4f2-c176-420c-80db-06415bf0b289 64679-758 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR; INTRAVENOUS 20070327 ANDA ANDA077942 WOCKHARDT USA LLC KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 64679-762_8e2eba78-5691-485a-8632-248a8e316bf0 64679-762 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20080530 ANDA ANDA078141 Wockhardt USA LLC. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64679-763_8e2eba78-5691-485a-8632-248a8e316bf0 64679-763 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20080530 ANDA ANDA078141 Wockhardt USA LLC. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64679-764_69999de8-02a0-450d-9704-01c16452a5cd 64679-764 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20081110 ANDA ANDA078511 Wockhardt USA LLC. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64679-765_69999de8-02a0-450d-9704-01c16452a5cd 64679-765 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20081110 ANDA ANDA078511 Wockhardt USA LLC. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64679-771_85371447-3b75-485c-959d-48274b7175c6 64679-771 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64679-773_85371447-3b75-485c-959d-48274b7175c6 64679-773 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64679-774_85371447-3b75-485c-959d-48274b7175c6 64679-774 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64679-775_85371447-3b75-485c-959d-48274b7175c6 64679-775 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64679-776_85371447-3b75-485c-959d-48274b7175c6 64679-776 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 64679-781_d7f7de90-ff9d-42ea-be6c-5fc0224801cb 64679-781 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20120930 NDA NDA020796 Wockhardt USA LLC. ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 64679-782_4f650f66-8782-4a3e-820a-37d6828b44d8 64679-782 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt USA LLC. CARBIDOPA; ENTACAPONE; LEVODOPA 12.5; 200; 50 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 64679-783_4f650f66-8782-4a3e-820a-37d6828b44d8 64679-783 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt USA LLC. CARBIDOPA; ENTACAPONE; LEVODOPA 18.75; 200; 75 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 64679-784_4f650f66-8782-4a3e-820a-37d6828b44d8 64679-784 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt USA LLC. CARBIDOPA; ENTACAPONE; LEVODOPA 25; 200; 100 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 64679-785_4f650f66-8782-4a3e-820a-37d6828b44d8 64679-785 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt USA LLC. CARBIDOPA; ENTACAPONE; LEVODOPA 31.25; 200; 125 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 64679-786_4f650f66-8782-4a3e-820a-37d6828b44d8 64679-786 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt USA LLC. CARBIDOPA; ENTACAPONE; LEVODOPA 37.5; 200; 150 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 64679-787_4f650f66-8782-4a3e-820a-37d6828b44d8 64679-787 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt USA LLC. CARBIDOPA; ENTACAPONE; LEVODOPA 50; 200; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 64679-810_5f296c99-aae6-4348-bdbd-b1fa3e2678d1 64679-810 HUMAN PRESCRIPTION DRUG Baycadron Dexamethasone ELIXIR ORAL 19830727 ANDA ANDA088254 Wockhardt USA, LLC DEXAMETHASONE .5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 64679-902_8846f1c7-aaac-443e-9b4b-81456a72068f 64679-902 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 19970328 ANDA ANDA074532 Wockhardt USA LLC. CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 64679-903_8846f1c7-aaac-443e-9b4b-81456a72068f 64679-903 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Wockhardt USA LLC. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 64679-904_8846f1c7-aaac-443e-9b4b-81456a72068f 64679-904 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Wockhardt USA LLC. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 64679-905_8846f1c7-aaac-443e-9b4b-81456a72068f 64679-905 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Wockhardt USA LLC. CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 64679-906_beec2e66-ef09-41a2-bd3a-2e3ab6d81373 64679-906 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 19981217 ANDA ANDA075208 WOCKHARDT USA LLC RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 64679-907_beec2e66-ef09-41a2-bd3a-2e3ab6d81373 64679-907 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 19981217 ANDA ANDA075208 WOCKHARDT USA LLC RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 64679-920_e696f1b5-e403-4d3f-b41d-91c0c2ea4be6 64679-920 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 Wockhardt USA LLC. CEFUROXIME AXETIL 125 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 64679-921_e696f1b5-e403-4d3f-b41d-91c0c2ea4be6 64679-921 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 Wockhardt USA LLC. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 64679-922_e696f1b5-e403-4d3f-b41d-91c0c2ea4be6 64679-922 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 Wockhardt USA LLC. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 64679-923_b3367a3e-0eb1-47c1-bdd2-84e3e80bfc8b 64679-923 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Wockhardt USA LLC. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 64679-924_b3367a3e-0eb1-47c1-bdd2-84e3e80bfc8b 64679-924 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Wockhardt USA LLC. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 64679-925_b3367a3e-0eb1-47c1-bdd2-84e3e80bfc8b 64679-925 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Wockhardt USA LLC. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 64679-926_b3367a3e-0eb1-47c1-bdd2-84e3e80bfc8b 64679-926 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Wockhardt USA LLC. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 64679-927_1eb7c620-53d1-40c5-8430-844605bd8574 64679-927 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt USA LLC. LISINOPRIL 2.5 mg/1 64679-928_1eb7c620-53d1-40c5-8430-844605bd8574 64679-928 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt USA LLC. LISINOPRIL 5 mg/1 64679-929_1eb7c620-53d1-40c5-8430-844605bd8574 64679-929 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt USA LLC. LISINOPRIL 10 mg/1 64679-936_3594e028-ee15-4e1d-b5d1-d9bcc7b70528 64679-936 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 Wockhardt USA LLC. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 64679-937_3594e028-ee15-4e1d-b5d1-d9bcc7b70528 64679-937 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 Wockhardt USA LLC. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 64679-941_1eb7c620-53d1-40c5-8430-844605bd8574 64679-941 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt USA LLC. LISINOPRIL 20 mg/1 64679-942_1eb7c620-53d1-40c5-8430-844605bd8574 64679-942 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt USA LLC. LISINOPRIL 40 mg/1 64679-945_a3b1846a-1ffe-4c0c-941e-6b2fbdeaa8e4 64679-945 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060727 ANDA ANDA077636 WOCKHARDT USA LLC. ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64679-946_a3b1846a-1ffe-4c0c-941e-6b2fbdeaa8e4 64679-946 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060727 ANDA ANDA077636 WOCKHARDT USA LLC. ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64679-947_daa07f7a-b8cb-475e-a10a-a6ce0aa503ed 64679-947 HUMAN PRESCRIPTION DRUG CEFOTAXIME CEFOTAXIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080620 ANDA ANDA065197 WOCKHARDT USA LLC. CEFOTAXIME SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 64679-948_daa07f7a-b8cb-475e-a10a-a6ce0aa503ed 64679-948 HUMAN PRESCRIPTION DRUG CEFOTAXIME CEFOTAXIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080620 ANDA ANDA065197 WOCKHARDT USA LLC. CEFOTAXIME SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 64679-949_91735224-fecb-4898-829c-9e97b9d5d626 64679-949 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20060531 ANDA ANDA065266 Wockhardt USA LLC. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 64679-953_1eb7c620-53d1-40c5-8430-844605bd8574 64679-953 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt USA LLC. LISINOPRIL 30 mg/1 64679-954_91735224-fecb-4898-829c-9e97b9d5d626 64679-954 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20060531 ANDA ANDA065266 Wockhardt USA LLC. CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 64679-961_d15dbc82-ec97-4459-9287-8442f6d79cbd 64679-961 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 WOCKHARDT USA LLC. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 64679-962_be627490-a919-48f1-8c4f-7c83dc0f1c6c 64679-962 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065302 WOCKHARDT USA LLC. AZITHROMYCIN ANHYDROUS 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 64679-964_d15dbc82-ec97-4459-9287-8442f6d79cbd 64679-964 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065405 WOCKHARDT USA LLC. AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 64679-965_e8e23827-3a73-4d85-8377-62d08dc6607c 64679-965 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride 5 mg TABLET ORAL 20030929 ANDA ANDA040532 Wockhardt USA LLC. BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 64679-966_e8e23827-3a73-4d85-8377-62d08dc6607c 64679-966 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride 10 mg TABLET ORAL 20030929 ANDA ANDA040533 Wockhardt USA LLC. BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 64679-967_e8e23827-3a73-4d85-8377-62d08dc6607c 64679-967 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride 25 mg TABLET ORAL 20030929 ANDA ANDA040534 Wockhardt USA LLC. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 64679-968_e8e23827-3a73-4d85-8377-62d08dc6607c 64679-968 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride 50 mg TABLET ORAL 20030929 ANDA ANDA040518 Wockhardt USA LLC. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 64679-972_c50c4e64-8314-4452-a5b8-e000185487eb 64679-972 HUMAN OTC DRUG FAMOTIDINE FAMOTIDINE TABLET ORAL 20050307 ANDA ANDA077146 WOCKHARDT USA LLC. FAMOTIDINE 10 mg/1 64679-973_bee2c182-1f98-4398-94b5-13656744b89f 64679-973 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE ORAL 20080731 ANDA ANDA077296 WOCKHARDT USA LLC DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64679-974_bee2c182-1f98-4398-94b5-13656744b89f 64679-974 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE ORAL 20080731 ANDA ANDA077296 WOCKHARDT USA LLC DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64679-975_bee2c182-1f98-4398-94b5-13656744b89f 64679-975 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE ORAL 20080731 ANDA ANDA077296 WOCKHARDT USA LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64679-976_4d31a613-a1a4-438c-ba28-950cf0a6163f 64679-976 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130213 ANDA ANDA078038 Wockhardt USA LLC. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 64679-977_4d31a613-a1a4-438c-ba28-950cf0a6163f 64679-977 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130213 ANDA ANDA078038 Wockhardt USA LLC. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 64679-978_4d31a613-a1a4-438c-ba28-950cf0a6163f 64679-978 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130213 ANDA ANDA078038 Wockhardt USA LLC. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 64679-982_3cc961b2-83fe-46d6-ba69-6f7e09927c09 64679-982 HUMAN OTC DRUG Fexofenadine Fexofenadine TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt USA LLC. FEXOFENADINE HYDROCHLORIDE 60 mg/1 64679-982_e8a55782-2ebf-4821-a954-928815fd80e9 64679-982 HUMAN OTC DRUG Fexofenadine Fexofenadine TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt USA LLC. FEXOFENADINE HYDROCHLORIDE 60 mg/1 64679-983_07a878ec-fc77-43fb-8b69-ecbd8307670a 64679-983 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060512 ANDA ANDA065180 Wockhardt USA LLC. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 64679-986_daa07f7a-b8cb-475e-a10a-a6ce0aa503ed 64679-986 HUMAN PRESCRIPTION DRUG CEFOTAXIME CEFOTAXIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060829 ANDA ANDA065197 WOCKHARDT USA LLC. CEFOTAXIME SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 64679-987_3cc961b2-83fe-46d6-ba69-6f7e09927c09 64679-987 HUMAN OTC DRUG Fexofenadine Fexofenadine TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt USA LLC. FEXOFENADINE HYDROCHLORIDE 180 mg/1 64679-987_e8a55782-2ebf-4821-a954-928815fd80e9 64679-987 HUMAN OTC DRUG Fexofenadine Fexofenadine TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt USA LLC. FEXOFENADINE HYDROCHLORIDE 180 mg/1 64679-990_a3b1846a-1ffe-4c0c-941e-6b2fbdeaa8e4 64679-990 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20051222 ANDA ANDA077636 WOCKHARDT USA LLC. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64679-991_f3e26558-ef69-404e-aed9-38e2b23d6f68 64679-991 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 Wockhardt USA LLC. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 64679-992_f3e26558-ef69-404e-aed9-38e2b23d6f68 64679-992 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 Wockhardt USA LLC. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 64679-993_f3e26558-ef69-404e-aed9-38e2b23d6f68 64679-993 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 Wockhardt USA LLC. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 64679-994_f3e26558-ef69-404e-aed9-38e2b23d6f68 64679-994 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 Wockhardt USA LLC. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 64680-0001_738dad7d-8d76-4574-b33c-6ef4a9287edb 64680-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990101 UNAPPROVED MEDICAL GAS HomeReach OXYGEN 99 L/100L 64693-001_62a1e4aa-1eec-4096-be5f-9863e73df8f1 64693-001 HUMAN PRESCRIPTION DRUG INOmax nitric oxide GAS RESPIRATORY (INHALATION) 19991223 NDA NDA020845 INO Therapeutics NITRIC OXIDE .123 mg/L Vasodilation [PE],Vasodilator [EPC] 64693-002_62a1e4aa-1eec-4096-be5f-9863e73df8f1 64693-002 HUMAN PRESCRIPTION DRUG INOmax nitric oxide GAS RESPIRATORY (INHALATION) 19991223 NDA NDA020845 INO Therapeutics NITRIC OXIDE .98 mg/L Vasodilation [PE],Vasodilator [EPC] 64696-1968_9d56bb06-cc9d-420f-878f-b9fc87028136 64696-1968 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20071128 UNAPPROVED MEDICAL GAS Ambercare Medical Supply Co. OXYGEN 99 L/100L 64712-001_4e0a66f2-de72-41e6-8cdd-2ab7a7d1def7 64712-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Health Complex Medical Inc OXYGEN 99 L/100L 64717-0513_4d5377c5-7238-4d16-819d-99e77c9b23bf 64717-0513 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980901 UNAPPROVED MEDICAL GAS JTW Inc. DBA Milburn Pharmacy OXYGEN 99 L/100L 64720-106_3c35b594-33bd-4a2d-ae48-aa336e9a8fdb 64720-106 HUMAN PRESCRIPTION DRUG TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET ORAL 20070206 ANDA ANDA076347 COREPHARMA LLC. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 64720-123_dd8bd137-921f-480b-b461-713de62beaf5 64720-123 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20020806 ANDA ANDA076257 CorePharma, LLC GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 64720-124_dd8bd137-921f-480b-b461-713de62beaf5 64720-124 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20020806 ANDA ANDA076257 CorePharma, LLC GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 64720-125_dd8bd137-921f-480b-b461-713de62beaf5 64720-125 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20020806 ANDA ANDA076257 CorePharma, LLC GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 64720-128_58f73089-4f10-4618-b407-5ae3edf23bb1 64720-128 HUMAN PRESCRIPTION DRUG Pyridostigmine Bromide Pyridostigmine Bromide TABLET ORAL 20030107 20150601 ANDA ANDA040457 CorePharma, LLC PYRIDOSTIGMINE BROMIDE 60 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 64720-130_ad6d3ce8-1a81-4c59-937b-106c42572e9b 64720-130 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate and amphetamine aspartate monohydrate and dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20070509 ANDA ANDA040444 CorePharma, LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 64720-131_ad6d3ce8-1a81-4c59-937b-106c42572e9b 64720-131 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20141107 ANDA ANDA040444 CorePharma, LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 64720-132_ad6d3ce8-1a81-4c59-937b-106c42572e9b 64720-132 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate and amphetamine aspartate monohydrate and dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20070509 ANDA ANDA040444 CorePharma, LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 64720-133_ad6d3ce8-1a81-4c59-937b-106c42572e9b 64720-133 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20141107 ANDA ANDA040444 CorePharma, LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 64720-134_ad6d3ce8-1a81-4c59-937b-106c42572e9b 64720-134 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20141107 ANDA ANDA040444 CorePharma, LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 64720-135_ad6d3ce8-1a81-4c59-937b-106c42572e9b 64720-135 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate and amphetamine aspartate monohydrate and dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20070509 ANDA ANDA040444 CorePharma, LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 64720-136_ad6d3ce8-1a81-4c59-937b-106c42572e9b 64720-136 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate and amphetamine aspartate monohydrate and dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20070509 ANDA ANDA040444 CorePharma, LLC AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 64720-137_23f3ba36-4a52-494b-8450-2ab232bf7ff3 64720-137 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride TABLET, FILM COATED ORAL 20041116 ANDA ANDA076746 CorePharma, LLC PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] 64720-138_3c35b594-33bd-4a2d-ae48-aa336e9a8fdb 64720-138 HUMAN PRESCRIPTION DRUG TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET ORAL 20070206 ANDA ANDA076347 COREPHARMA LLC. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 64720-139_07fc196d-df18-4ab2-91df-e584cbd00398 64720-139 HUMAN PRESCRIPTION DRUG Methenamine Hippurate Methenamine Hippurate TABLET ORAL 20030701 ANDA ANDA076411 CorePharma, LLC METHENAMINE HIPPURATE 1 g/1 64720-140_59e84584-502d-4739-b106-8a240cfc80ad 64720-140 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20041119 ANDA ANDA076731 CorePharma, LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 64720-141_59e84584-502d-4739-b106-8a240cfc80ad 64720-141 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20041119 ANDA ANDA076731 CorePharma, LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 64720-142_59e84584-502d-4739-b106-8a240cfc80ad 64720-142 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20041119 ANDA ANDA076731 CorePharma, LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 64720-143_78d6f8c6-5735-4ca9-a3e0-b1c42b41330a 64720-143 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20020813 ANDA ANDA072264 Corepharma LLC. BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 64720-144_78d6f8c6-5735-4ca9-a3e0-b1c42b41330a 64720-144 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20020813 ANDA ANDA072265 Corepharma LLC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 64720-145_78d6f8c6-5735-4ca9-a3e0-b1c42b41330a 64720-145 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20020813 ANDA ANDA072266 Corepharma LLC. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 64720-150_4e618a99-c3f9-48c0-b467-8831b4871fb5 64720-150 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20030930 ANDA ANDA040537 CorePharma, LLC CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 64720-152_137246a1-ab32-4ef2-91ce-3f6246824524 64720-152 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20051212 ANDA ANDA065182 CorePharma, LLC DOXYCYCLINE HYCLATE 20 mg/1 64720-153_c7891120-ef2b-4fa8-83f2-553c5c6492c6 64720-153 HUMAN PRESCRIPTION DRUG clindamycin hydrochloride clindamycin hydrochloride CAPSULE, GELATIN COATED ORAL 20040415 ANDA ANDA065194 CorePharma, LLC CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 64720-154_c7891120-ef2b-4fa8-83f2-553c5c6492c6 64720-154 HUMAN PRESCRIPTION DRUG clindamycin hydrochloride clindamycin hydrochloride CAPSULE, GELATIN COATED ORAL 20040415 ANDA ANDA065194 CorePharma, LLC CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 64720-158_ec2778cb-ea67-4c1b-9e90-2a1d32fb5e20 64720-158 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20060906 ANDA ANDA077150 Corepharma LLC. CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 64720-159_ec2778cb-ea67-4c1b-9e90-2a1d32fb5e20 64720-159 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20060906 ANDA ANDA077022 Corepharma LLC. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 64720-183_2d6721ca-bc76-4639-a78b-b9b0b2fc67b9 64720-183 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET, EXTENDED RELEASE ORAL 20080402 ANDA ANDA040723 CorePharma, LLC ISOSORBIDE DINITRATE 40 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 64720-187_b9789094-cdd8-4f4a-b783-c06b9ad840b0 64720-187 HUMAN PRESCRIPTION DRUG ALPRAZOLAM extended release ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070328 ANDA ANDA077996 CorePharma, LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64720-188_b9789094-cdd8-4f4a-b783-c06b9ad840b0 64720-188 HUMAN PRESCRIPTION DRUG ALPRAZOLAM extended release ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070328 ANDA ANDA077996 CorePharma, LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64720-189_b9789094-cdd8-4f4a-b783-c06b9ad840b0 64720-189 HUMAN PRESCRIPTION DRUG ALPRAZOLAM extended release ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070328 ANDA ANDA077996 CorePharma, LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64720-190_b9789094-cdd8-4f4a-b783-c06b9ad840b0 64720-190 HUMAN PRESCRIPTION DRUG ALPRAZOLAM extended release ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070328 ANDA ANDA077996 CorePharma, LLC ALPRAZOLAM 3 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64720-198_b6bc8b8f-3796-4812-8662-472e8688b306 64720-198 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20071231 ANDA ANDA078260 CorePharma, LLC GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 64720-208_788fbf08-575e-4564-a44c-d8bc1972e704 64720-208 HUMAN PRESCRIPTION DRUG DIETHYLPROPION HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE TABLET ORAL 20081106 ANDA ANDA040828 Corepharma LLC. DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 64720-212_6ec1c9eb-a25e-41d4-9ba8-63540c2713fa 64720-212 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin TABLET, CHEWABLE ORAL 20141208 ANDA ANDA040884 CorePharma, LLC PHENYTOIN 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64720-215_eecfcad2-55d9-42f6-9a99-9d53da05320f 64720-215 HUMAN PRESCRIPTION DRUG DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET ORAL 20140515 ANDA ANDA090652 CorePharma, LLC DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 64720-216_eecfcad2-55d9-42f6-9a99-9d53da05320f 64720-216 HUMAN PRESCRIPTION DRUG DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET ORAL 20140515 ANDA ANDA090652 CorePharma, LLC DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 64720-224_cd348b26-5814-46f6-a442-0516b4146db1 64720-224 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20091027 ANDA ANDA090895 CorePharma, LLC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 64720-225_cd348b26-5814-46f6-a442-0516b4146db1 64720-225 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20091027 ANDA ANDA090895 CorePharma, LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 64720-226_cd348b26-5814-46f6-a442-0516b4146db1 64720-226 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20091027 ANDA ANDA090895 CorePharma, LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 64720-237_a15cf428-b3bf-476f-a676-c8279171e5c4 64720-237 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 20140407 ANDA ANDA091159 CorePharma, LLC METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 64720-238_a15cf428-b3bf-476f-a676-c8279171e5c4 64720-238 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 20140407 ANDA ANDA091159 CorePharma, LLC METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 64720-239_a15cf428-b3bf-476f-a676-c8279171e5c4 64720-239 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 20140407 ANDA ANDA091159 CorePharma, LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 64720-295_4541e189-ea2d-4900-8a8f-7110243181b8 64720-295 HUMAN PRESCRIPTION DRUG Ultramicrosize Griseofulvin Ultramicrosize Griseofulvin Tablets TABLET, COATED ORAL 20140929 ANDA ANDA204371 CorePharma, LLC GRISEOFULVIN 125 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 64720-296_4541e189-ea2d-4900-8a8f-7110243181b8 64720-296 HUMAN PRESCRIPTION DRUG Ultramicrosize Griseofulvin Ultramicrosize Griseofulvin Tablets TABLET, COATED ORAL 20140929 ANDA ANDA204371 CorePharma, LLC GRISEOFULVIN 250 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 64720-321_dc7aa7b3-f75a-4bc1-ad08-42d9561d1287 64720-321 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 CorePharma, LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 64720-327_1a8fd2f2-fedb-45f5-a634-37fdb4d84c7a 64720-327 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20110901 NDA NDA017078 Corepharma LLC. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 64720-328_1a8fd2f2-fedb-45f5-a634-37fdb4d84c7a 64720-328 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20110901 NDA NDA017078 Corepharma LLC. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 64720-329_1a8fd2f2-fedb-45f5-a634-37fdb4d84c7a 64720-329 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20110901 NDA NDA017078 Corepharma LLC. DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 64720-331_cc89da50-f2f2-11e2-b778-0800200c9a66 64720-331 HUMAN PRESCRIPTION DRUG HYDROCORTISONE hydrocortisone TABLET ORAL 20091231 20150228 ANDA ANDA040646 Corepharma LLC. HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 64720-334_829c58fa-0aa6-4d8b-a70a-b74a970c1979 64720-334 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET ORAL 20120918 NDA NDA050261 CorePharma, LLC DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 64720-335_829c58fa-0aa6-4d8b-a70a-b74a970c1979 64720-335 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET ORAL 20120918 NDA NDA050261 CorePharma, LLC DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 64724-1016_26db114c-1985-42fd-b3d4-746537af9cbd 64724-1016 HUMAN OTC DRUG NATURALTECH PURIFYING ANTI-DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20120229 OTC MONOGRAPH FINAL part358H Davines S.p.A. SELENIUM SULFIDE .6 mL/100mL 64724-1017_c12cc885-4845-41d9-a04d-15062ff6bb01 64724-1017 HUMAN OTC DRUG NATURALTECH PURIFYING ANTI-DANDRUFF PYRITHIONE ZINC GEL TOPICAL 20120229 OTC MONOGRAPH FINAL part358H Davines S.p.A. PYRITHIONE ZINC .48 mL/100mL 64725-0003_11c6fa42-464d-4468-99b6-d6c6eadd7f2c 64725-0003 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 TYA Pharmaceuticals MIRTAZAPINE 30 mg/1 64725-0004_ef3921b4-9f0f-4338-a7ce-38e3450a1230 64725-0004 HUMAN OTC DRUG MI-ACID REGULAR STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part331 TYA Pharmaceuticals ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 64725-0006_86ddf799-88d3-4d05-ae29-34e13a89cd22 64725-0006 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 TYA Pharmaceuticals ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] 64725-0007_86ddf799-88d3-4d05-ae29-34e13a89cd22 64725-0007 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 TYA Pharmaceuticals ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] 64725-0008_fd282b6a-5788-48e6-bea4-dc2998a492df 64725-0008 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 TYA Pharmaceuticals ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 64725-0009_1c1e7873-4fbf-4033-94d7-9fd8416b828e 64725-0009 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 TYA Pharmaceuticals ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] 64725-0010_58dcf6a8-3134-406d-9999-43f7212834df 64725-0010 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 TYA Pharmaceuticals CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64725-0012_9573c6b0-a783-4559-8e44-74ee89fc28a2 64725-0012 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20120808 NDA AUTHORIZED GENERIC NDA012015 TYA Pharmaceuticals BENZTROPINE MESYLATE 1 mg/mL Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 64725-0017_1ff9ff68-ac5f-4b77-b62a-7ca1b0919176 64725-0017 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 TYA Pharmaceuticals AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 64725-0034_a725cf7e-3cda-484d-acaf-28f3ace2dcbc 64725-0034 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 TYA Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64725-0036_a725cf7e-3cda-484d-acaf-28f3ace2dcbc 64725-0036 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 TYA Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64725-0041_364f49ee-04a1-4130-b4f6-93ae21a9c3c7 64725-0041 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 TYA Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 64725-0045_fefc0b73-ba82-4ff3-b3ac-75860885cb45 64725-0045 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20101210 ANDA ANDA079237 TYA Pharmaceuticals HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 64725-0047_c2dad462-8302-427f-91e3-e1c08a9b2a34 64725-0047 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100820 ANDA ANDA040807 TYA Pharmaceuticals HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 64725-0056_464e51ff-2b84-44b4-82e4-34b4f19e677f 64725-0056 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 TYA Pharmaceuticals WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 64725-0058_1aef037e-5758-415a-ae16-a32d6b1d5fe7 64725-0058 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 TYA Pharmaceuticals GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 64725-0080_2e6f2b3e-1cc5-4121-8354-a169da971973 64725-0080 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080103 ANDA ANDA077580 TYA Pharmaceuticals HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] 64725-0083_f22e1d97-8bc3-4879-a177-e76481ec4ffc 64725-0083 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 TYA Pharmaceuticals PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64725-0097_f22e1d97-8bc3-4879-a177-e76481ec4ffc 64725-0097 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 TYA Pharmaceuticals PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64725-0101_3d443c42-3db1-4cd0-a5f6-9fdd47f19869 64725-0101 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120112 ANDA ANDA062713 TYA Pharmaceuticals CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 64725-0102_ade7f111-e31f-44db-8f9c-3cb479fafad8 64725-0102 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 TYA Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 64725-0110_8cac22bb-9205-4c92-a5ae-912ac62e632a 64725-0110 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 TYA Pharmaceuticals PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 64725-0111_858f7e7f-5d6b-46dc-a1df-4e3e7229ea24 64725-0111 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111101 ANDA ANDA090170 TYA Pharmaceuticals LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64725-0112_858f7e7f-5d6b-46dc-a1df-4e3e7229ea24 64725-0112 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111101 ANDA ANDA090170 TYA Pharmaceuticals LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64725-0113_271f3da1-d81a-4938-94bd-84486e946655 64725-0113 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 TYA Pharmaceuticals RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 64725-0114_271f3da1-d81a-4938-94bd-84486e946655 64725-0114 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 TYA Pharmaceuticals RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 64725-0121_73e3c0cc-32d7-46ff-b7a5-693bd3b78a46 64725-0121 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060111 ANDA ANDA065229 TYA Pharmaceuticals CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 64725-0126_7a56733c-238a-4b87-b713-39220882bd53 64725-0126 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 TYA Pharmaceuticals GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64725-0136_c8b952cf-9bd9-4b1d-9739-b38afca10e02 64725-0136 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20101124 ANDA ANDA077147 TYA Pharmaceuticals CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64725-0137_b3b282db-b87e-456f-9c71-3f13d2e1ddb9 64725-0137 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077802 TYA Pharmaceuticals OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64725-0138_dbba4900-cfca-4dd9-8241-b8a675ab6128 64725-0138 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20060824 ANDA ANDA077242 TYA Pharmaceuticals GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64725-0139_5c19918f-203d-46cb-b7ac-f4d81a6f9a90 64725-0139 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110301 ANDA ANDA074550 TYA Pharmaceuticals GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 64725-0145_6101afa7-97c1-4445-ae8a-1bca25f03333 64725-0145 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 TYA Pharmaceuticals QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 64725-0146_05026ebb-617d-47ff-ac20-51d2c14a528d 64725-0146 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 19860825 ANDA ANDA071017 TYA Pharmaceuticals SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 64725-0147_1c75b165-9530-4892-a732-ca5fac322235 64725-0147 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 TYA Pharmaceuticals QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 64725-0148_6101afa7-97c1-4445-ae8a-1bca25f03333 64725-0148 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 TYA Pharmaceuticals QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 64725-0158_bdead3a9-9287-4c36-b38b-c53a2bb35fa3 64725-0158 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 TYA Pharmaceuticals OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 64725-0159_6689dca3-528e-4013-89d5-b42fcca486d7 64725-0159 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19760702 ANDA ANDA084769 TYA Pharmaceuticals CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64725-0161_e64758bf-e522-4c96-b9ac-c920a200e210 64725-0161 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20101117 ANDA ANDA091630 TYA Pharmaceuticals TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 64725-0169_290c9184-8e8a-4512-bc7e-20af6d596c85 64725-0169 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 TYA Pharmaceuticals HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 64725-0170_290c9184-8e8a-4512-bc7e-20af6d596c85 64725-0170 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 TYA Pharmaceuticals HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 64725-0192_e99df3bf-a3bd-4d37-9632-acefe2359e50 64725-0192 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 TYA Pharmaceuticals FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64725-0193_e99df3bf-a3bd-4d37-9632-acefe2359e50 64725-0193 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 TYA Pharmaceuticals FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64725-0209_8ec7115c-b3e2-428b-9bb8-8e6516054381 64725-0209 HUMAN OTC DRUG Siltussin DM Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 19920905 OTC MONOGRAPH FINAL part341 TYA Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 64725-0212_b764f252-3d81-4947-ba41-89c29326f484 64725-0212 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 TYA Pharmaceuticals SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64725-0213_b764f252-3d81-4947-ba41-89c29326f484 64725-0213 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 TYA Pharmaceuticals SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64725-0214_f3a5ed5a-a76e-4b7a-91a8-5d5e0c3d33b8 64725-0214 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19860610 ANDA ANDA070278 TYA Pharmaceuticals HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] 64725-0215_2dfe29d8-d1da-4ee7-be45-e87c779d3d7c 64725-0215 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 TYA Pharmaceuticals CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 64725-0221_dba983ee-133b-45c2-b552-c5e999b48980 64725-0221 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 TYA Pharmaceuticals GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64725-0222_dba983ee-133b-45c2-b552-c5e999b48980 64725-0222 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 TYA Pharmaceuticals GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64725-0238_09bd05f2-2c3f-47b0-9b25-9da517dec583 64725-0238 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 TYA Pharmaceuticals AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 64725-0242_aed23cc5-a21d-4d2c-8a9d-df1657d594ab 64725-0242 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072928 TYA Pharmaceuticals LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64725-0247_b7a6199a-9010-4f2d-8887-f701d6e7068b 64725-0247 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 TYA Pharmaceuticals MIRTAZAPINE 15 mg/1 64725-0250_2a6665b4-9ccd-4778-913a-e7d805250d0c 64725-0250 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET ORAL 20120911 ANDA ANDA078604 TYA Pharmaceuticals ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64725-0251_2a6665b4-9ccd-4778-913a-e7d805250d0c 64725-0251 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET ORAL 20120911 ANDA ANDA078604 TYA Pharmaceuticals ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64725-0259_d91c0167-00cf-44e5-8d0f-0629b5241bfa 64725-0259 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077565 TYA Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 64725-0265_ecec32e8-eb3f-4c1c-87cd-d459f59ed6fb 64725-0265 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA076534 TYA Pharmaceuticals OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 64725-0272_e162b234-b57c-4326-b661-0f5c3c4d3e08 64725-0272 HUMAN PRESCRIPTION DRUG Fluphenazine Decanoate FLUPHENAZINE DECANOATE INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20101215 ANDA ANDA071413 TYA Pharmaceuticals FLUPHENAZINE DECANOATE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 64725-0280_09f9c7b9-7622-4089-b6b9-8e5be366a398 64725-0280 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20090201 NDA NDA022047 TYA Pharmaceuticals QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 64725-0281_09f9c7b9-7622-4089-b6b9-8e5be366a398 64725-0281 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20090201 NDA NDA022047 TYA Pharmaceuticals QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] 64725-0282_09f9c7b9-7622-4089-b6b9-8e5be366a398 64725-0282 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20070716 NDA NDA022047 TYA Pharmaceuticals QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 64725-0283_09f9c7b9-7622-4089-b6b9-8e5be366a398 64725-0283 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20070716 NDA NDA022047 TYA Pharmaceuticals QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 64725-0284_09f9c7b9-7622-4089-b6b9-8e5be366a398 64725-0284 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20070716 NDA NDA022047 TYA Pharmaceuticals QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 64725-0292_885b029e-8ee6-4aa6-acf9-338058069e3d 64725-0292 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20080111 ANDA ANDA078069 TYA Pharmaceuticals OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64725-0302_11445e6b-4efa-40db-909c-5c6ad3d056cb 64725-0302 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19840701 ANDA ANDA088487 TYA Pharmaceuticals HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 64725-0304_39bbc251-0443-466d-b10e-7503e844e056 64725-0304 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084115 TYA Pharmaceuticals CHLORPROMAZINE HYDROCHLORIDE 200 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 64725-0314_af3febff-f6b0-4bb3-9f83-142ef96135e9 64725-0314 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended-Release Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20000804 NDA AUTHORIZED GENERIC NDA021168 TYA Pharmaceuticals DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64725-0315_af3febff-f6b0-4bb3-9f83-142ef96135e9 64725-0315 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended-Release Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20130812 NDA AUTHORIZED GENERIC NDA021168 TYA Pharmaceuticals DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64725-0319_ee72430a-f6cd-4cbc-a312-102c266bf965 64725-0319 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20120425 ANDA ANDA201003 TYA Pharmaceuticals RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 64725-0321_ee72430a-f6cd-4cbc-a312-102c266bf965 64725-0321 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20120425 ANDA ANDA201003 TYA Pharmaceuticals RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 64725-0323_11445e6b-4efa-40db-909c-5c6ad3d056cb 64725-0323 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19840701 ANDA ANDA088496 TYA Pharmaceuticals HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 64725-0327_f3a5ed5a-a76e-4b7a-91a8-5d5e0c3d33b8 64725-0327 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19860610 ANDA ANDA070278 TYA Pharmaceuticals HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 64725-0351_3d8002ca-2951-4a47-a101-754ceed78309 64725-0351 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 TYA Pharmaceuticals SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64725-0361_5cea160b-a566-4b0d-8a9e-1c7b532e9c61 64725-0361 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091202 ANDA ANDA040625 TYA Pharmaceuticals FOLIC ACID 1 mg/1 64725-0376_ee7a0577-37b2-4747-b7c4-64cb7e74000e 64725-0376 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19721127 ANDA ANDA080817 TYA Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 64725-0397_45704b63-7b42-4685-882a-7d2559eda79f 64725-0397 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 TYA Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 64725-0401_f078b2e9-e6d3-41aa-b48c-7c65f4ea9f30 64725-0401 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 TYA Pharmaceuticals DOCUSATE SODIUM 100 mg/1 64725-0434_476c6f63-97d9-4142-b778-58d72af4ab38 64725-0434 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071524 TYA Pharmaceuticals TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 64725-0465_0bee8638-785e-4a54-bb8d-bad1a972c82c 64725-0465 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 TYA Pharmaceuticals IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 64725-0471_b948d2eb-c7fa-49f2-bd68-18482f85dc72 64725-0471 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate HALOPERIDOL DECANOATE INJECTION INTRAMUSCULAR 20000712 ANDA ANDA074893 TYA Pharmaceuticals HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] 64725-0477_ff4f2a34-1129-42d8-85da-e77666063693 64725-0477 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 TYA Pharmaceuticals METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 64725-0490_cf020deb-1ded-413c-912d-299443a61f6f 64725-0490 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140411 ANDA ANDA074661 TYA Pharmaceuticals NAPROXEN SODIUM 220 mg/1 64725-0500_9fa83fd2-deeb-4996-8771-19f12e7ac629 64725-0500 HUMAN PRESCRIPTION DRUG EPIPEN epinephrine INJECTION INTRAMUSCULAR 19871222 NDA NDA019430 TYA Pharmaceuticals EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 64725-0501_9fa83fd2-deeb-4996-8771-19f12e7ac629 64725-0501 HUMAN PRESCRIPTION DRUG EPIPEN JR epinephrine INJECTION INTRAMUSCULAR 19871222 NDA NDA019430 TYA Pharmaceuticals EPINEPHRINE .15 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 64725-0507_3dabf6fb-1c36-4841-b8af-61a0690c7f90 64725-0507 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20041112 ANDA ANDA077032 TYA Pharmaceuticals CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64725-0511_e1cd96a9-6dfc-455a-9624-ba92e9c85c1e 64725-0511 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 TYA Pharmaceuticals GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64725-0513_6d3d53d5-10d9-46a7-a251-f1eb1a2ffeeb 64725-0513 HUMAN PRESCRIPTION DRUG Intuniv guanfacine TABLET, EXTENDED RELEASE ORAL 20090902 NDA NDA022037 TYA Pharmaceuticals GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 64725-0514_5d172892-ed60-4914-934b-74c9771a2d5b 64725-0514 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 TYA Pharmaceuticals LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 64725-0515_6d3d53d5-10d9-46a7-a251-f1eb1a2ffeeb 64725-0515 HUMAN PRESCRIPTION DRUG Intuniv guanfacine TABLET, EXTENDED RELEASE ORAL 20090902 NDA NDA022037 TYA Pharmaceuticals GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 64725-0544_16ffae65-14fe-4f4b-9214-0030b07d7ecf 64725-0544 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 TYA Pharmaceuticals LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] 64725-0545_16ffae65-14fe-4f4b-9214-0030b07d7ecf 64725-0545 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 TYA Pharmaceuticals LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 64725-0550_67e10f52-3747-4542-bb6e-1afccd2df3fc 64725-0550 HUMAN PRESCRIPTION DRUG INVEGA paliperidone TABLET, EXTENDED RELEASE ORAL 20061219 NDA NDA021999 TYA Pharmaceuticals PALIPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 64725-0552_c7d79e6a-46cb-4ba7-bcb4-510604307cd1 64725-0552 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA091038 TYA Pharmaceuticals OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 64725-0554_c7d79e6a-46cb-4ba7-bcb4-510604307cd1 64725-0554 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA091038 TYA Pharmaceuticals OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 64725-0555_c7d79e6a-46cb-4ba7-bcb4-510604307cd1 64725-0555 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA091038 TYA Pharmaceuticals OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 64725-0579_119c2f38-9836-4cec-b6d5-990be9f47818 64725-0579 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090324 ANDA ANDA078459 TYA Pharmaceuticals METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 64725-0586_67e197bb-1535-4f76-9672-ba62f836735b 64725-0586 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19740930 ANDA ANDA084285 TYA Pharmaceuticals DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 64725-0595_c99e62c9-59d6-4461-a36d-ec6127d3954d 64725-0595 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140602 ANDA ANDA202419 TYA Pharmaceuticals DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64725-0600_cc2bbbc5-dd33-4821-a97a-cc7452815998 64725-0600 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110222 NDA AUTHORIZED GENERIC NDA018279 TYA Pharmaceuticals POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 64725-0604_687b4bc7-0ea2-4602-a75c-5402739f1732 64725-0604 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 TYA Pharmaceuticals ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64725-0621_45ecdad5-5b7b-4eb4-b8b0-f89d02ad60e5 64725-0621 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 TYA Pharmaceuticals ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 64725-0624_031a2a0f-f357-45ed-9719-67ed4c7bca8f 64725-0624 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 TYA Pharmaceuticals FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 64725-0625_031a2a0f-f357-45ed-9719-67ed4c7bca8f 64725-0625 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 TYA Pharmaceuticals FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 64725-0649_0b22d1e4-6b18-48b1-890e-9d2c147f0acc 64725-0649 HUMAN OTC DRUG MILK OF MAGNESIA ORIGINAL magnesium hydroxide LIQUID ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 TYA Pharmaceuticals MAGNESIUM HYDROXIDE 1200 mg/15mL 64725-0657_516341c3-df40-4da4-ad5b-9f54427589bf 64725-0657 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 TYA Pharmaceuticals BUSPIRONE HYDROCHLORIDE 5 mg/1 64725-0658_516341c3-df40-4da4-ad5b-9f54427589bf 64725-0658 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 TYA Pharmaceuticals BUSPIRONE HYDROCHLORIDE 10 mg/1 64725-0691_c8f056bb-0ec7-49bb-96c5-723dd5d93a41 64725-0691 HUMAN OTC DRUG Sunmark Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050623 ANDA ANDA078325 TYA Pharmaceuticals NICOTINE 2 mg/1 64725-0707_494c452e-d8fc-482e-9eb4-64c7a92c14ce 64725-0707 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 TYA Pharmaceuticals TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64725-0710_494c452e-d8fc-482e-9eb4-64c7a92c14ce 64725-0710 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 TYA Pharmaceuticals TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64725-0711_f4bba57b-92f5-4850-b329-36ee214dc013 64725-0711 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine Hydrochloride TABLET ORAL 19981125 ANDA ANDA075109 TYA Pharmaceuticals GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 64725-0716_b2310339-e7c0-4deb-9899-ba0a692891bb 64725-0716 HUMAN OTC DRUG Plus Pharma NSAID 325 mg ASPIRIN TABLET ORAL 20140929 OTC MONOGRAPH FINAL part343 TYA Pharmaceuticals ASPIRIN 81 mg/1 64725-0720_ec4681c5-a369-4557-af26-fc5695772023 64725-0720 HUMAN PRESCRIPTION DRUG EXTENDED PHENYTOIN SODIUM EXTENDED PHENYTOIN SODIUM CAPSULE ORAL 20080130 ANDA ANDA040732 TYA Pharmaceuticals PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64725-0736_a48f17ec-bca5-486d-a68e-aceaa66d57c6 64725-0736 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 TYA Pharmaceuticals BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 64725-0737_a48f17ec-bca5-486d-a68e-aceaa66d57c6 64725-0737 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 TYA Pharmaceuticals BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 64725-0747_d086a93f-bee2-4ef5-859c-d593485aa83c 64725-0747 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 TYA Pharmaceuticals DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64725-0750_f92b7a9d-49f8-4b5e-9598-7d2c606ff62f 64725-0750 HUMAN PRESCRIPTION DRUG NovoLog insulin aspart INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20010827 NDA NDA020986 TYA Pharmaceuticals INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 64725-0751_0c423960-d654-405a-9c7e-75786213899f 64725-0751 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120228 ANDA ANDA090881 TYA Pharmaceuticals OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 64725-0757_0c423960-d654-405a-9c7e-75786213899f 64725-0757 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120228 ANDA ANDA090881 TYA Pharmaceuticals OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 64725-0772_0af9a6fe-84a2-4f34-b0ff-76646d52e917 64725-0772 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20011211 ANDA ANDA076045 TYA Pharmaceuticals LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64725-0773_0af9a6fe-84a2-4f34-b0ff-76646d52e917 64725-0773 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20011211 ANDA ANDA076045 TYA Pharmaceuticals LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64725-0797_e209f276-8e72-43a3-94e5-aef94ac76054 64725-0797 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 TYA Pharmaceuticals DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64725-0798_e209f276-8e72-43a3-94e5-aef94ac76054 64725-0798 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 TYA Pharmaceuticals DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 64725-0800_2d448e1b-79d2-4342-83ec-ed95113d6611 64725-0800 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 TYA Pharmaceuticals HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 64725-0801_2d448e1b-79d2-4342-83ec-ed95113d6611 64725-0801 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960615 ANDA ANDA040156 TYA Pharmaceuticals HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 64725-0833_42473c39-b5b9-429c-a21f-8c63cbb65310 64725-0833 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 ANDA ANDA040145 TYA Pharmaceuticals WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 64725-0911_9306182b-23de-4c41-b811-f1375e91d966 64725-0911 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol INJECTION INTRAMUSCULAR 20110617 NDA AUTHORIZED GENERIC NDA015923 TYA Pharmaceuticals HALOPERIDOL 5 mg/mL Typical Antipsychotic [EPC] 64725-0924_590283db-1dad-42e4-9ce8-077be2f99ca1 64725-0924 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 TYA Pharmaceuticals ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 64725-0955_e66eb52e-210e-49f2-910d-38ac51616e63 64725-0955 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20120627 ANDA ANDA201741 TYA Pharmaceuticals OLANZAPINE 10 mg/2mL Atypical Antipsychotic [EPC] 64725-0981_1fcb1187-31a2-413d-9edd-85bcd07aacec 64725-0981 HUMAN OTC DRUG Adult Low Dose Enteric Coated Aspirin Aspirin TABLET, COATED ORAL 20000701 OTC MONOGRAPH FINAL part343 TYA Pharmaceuticals ASPIRIN 81 mg/1 64725-0993_3661200b-ba45-45c7-b29b-714b1fe94955 64725-0993 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 TYA Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 64725-0994_3661200b-ba45-45c7-b29b-714b1fe94955 64725-0994 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 TYA Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 64725-1020_b33bdf2c-8947-4d30-b72f-1364a018446c 64725-1020 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 TYA Pharmaceuticals LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 64725-1021_a30dae23-cefc-4d9b-bd47-44a33cba2afc 64725-1021 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120112 ANDA ANDA062713 TYA Pharmaceuticals CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 64725-1053_684cc89b-47f5-4a11-a256-14f36484cf8d 64725-1053 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 TYA Pharmaceuticals BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 64725-1100_1d38892a-0a36-46eb-9f99-7b91b7337fd8 64725-1100 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 TYA Pharmaceuticals DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64725-1110_8cac22bb-9205-4c92-a5ae-912ac62e632a 64725-1110 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 TYA Pharmaceuticals PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 64725-1117_4b21397b-a3cf-4651-8b30-e80e8600e00c 64725-1117 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076312 TYA Pharmaceuticals MIRTAZAPINE 15 mg/1 64725-1130_bcac1969-90c5-4abe-a3af-94566ef8a85c 64725-1130 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 TYA Pharmaceuticals LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64725-1258_b1dfde1b-4727-42f6-8fd7-80590567f59a 64725-1258 HUMAN OTC DRUG antacid calcium carbonate TABLET, CHEWABLE ORAL 19920807 OTC MONOGRAPH FINAL part331 TYA Pharmaceuticals CALCIUM CARBONATE 500 mg/1 64725-1260_089b76b6-71af-4893-bb1b-4890fcc4a3e5 64725-1260 HUMAN PRESCRIPTION DRUG Clozaril clozapine TABLET ORAL 19890930 NDA NDA019758 TYA Pharmaceuticals CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] 64725-1324_137ab467-1a5e-4159-a27d-54700ff0369e 64725-1324 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 TYA Pharmaceuticals DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 64725-1397_e4d5f9da-e10d-40ca-8abd-66d2de237db1 64725-1397 HUMAN PRESCRIPTION DRUG Chlorpromazine hydrochloride Chlorpromazine hydrochloride INJECTION INTRAMUSCULAR 19740725 ANDA ANDA083329 TYA Pharmaceuticals CHLORPROMAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 64725-1438_1069b2e7-e199-4a74-aa49-19a754d3b70d 64725-1438 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19871016 ANDA ANDA089586 TYA Pharmaceuticals FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 64725-1473_f2b2764d-88e6-41cd-8b7d-be9d82f3ecc0 64725-1473 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19851204 ANDA ANDA088832 TYA Pharmaceuticals PREDNISONE 10 mg/1 64725-1487_15986746-62f9-4539-969a-da2396a26bcc 64725-1487 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 TYA Pharmaceuticals AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 64725-1488_15986746-62f9-4539-969a-da2396a26bcc 64725-1488 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 TYA Pharmaceuticals AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 64725-1782_4e92d5c6-3c12-4817-8ce9-c322dca29445 64725-1782 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19860924 ANDA ANDA070172 TYA Pharmaceuticals NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 64725-1833_a2c745d7-1b63-4064-b6a1-e18e43b318ad 64725-1833 HUMAN OTC DRUG Novolin R Human Insulin INJECTION, SOLUTION SUBCUTANEOUS 19910625 NDA NDA019938 TYA Pharmaceuticals INSULIN HUMAN 100 [iU]/mL 64725-1834_88240c8b-10c5-43b4-8a36-020380cea930 64725-1834 HUMAN OTC DRUG Novolin N Human Insulin INJECTION, SUSPENSION SUBCUTANEOUS 19910701 NDA NDA019959 TYA Pharmaceuticals INSULIN HUMAN 100 [iU]/mL 64725-1837_05dc7def-3137-4c5c-8d43-2baf9d7888df 64725-1837 HUMAN OTC DRUG Novolin 70/30 Human Insulin INJECTION, SUSPENSION SUBCUTANEOUS 19910625 NDA NDA019991 TYA Pharmaceuticals INSULIN HUMAN 100 [USP&apos'U]/mL 64725-1945_123b4dce-02c1-4b3b-a688-cac53b0d7a94 64725-1945 HUMAN OTC DRUG RULOX REGULAR aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110105 OTC MONOGRAPH FINAL part331 TYA Pharmaceuticals ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 64725-2057_70bd0f0c-73c3-4b70-8fed-7bcd87723d1a 64725-2057 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20121018 ANDA ANDA075269 TYA Pharmaceuticals NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 64725-2164_85fb1966-59ca-453a-8a7f-17092ef729aa 64725-2164 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130213 ANDA ANDA077562 TYA Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 64725-2168_85fb1966-59ca-453a-8a7f-17092ef729aa 64725-2168 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130213 ANDA ANDA077562 TYA Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 64725-2202_a105e034-4303-43be-bad9-48101881e9a9 64725-2202 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19880112 ANDA ANDA071428 TYA Pharmaceuticals TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64725-2220_7d9b3b09-2b30-40a4-8b37-38d2e6af3abf 64725-2220 HUMAN PRESCRIPTION DRUG Lantus insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20090923 NDA NDA021081 TYA Pharmaceuticals INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 64725-2434_f3659fef-8fd1-4576-8233-ffaafd41a514 64725-2434 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040742 TYA Pharmaceuticals BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 64725-2435_f3659fef-8fd1-4576-8233-ffaafd41a514 64725-2435 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040715 TYA Pharmaceuticals BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 64725-2527_d1a3410e-fc15-4b8f-8a9c-41c90a0302ad 64725-2527 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19801126 NDA NDA017812 TYA Pharmaceuticals LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 64725-2810_ff75d29a-d733-4f97-aaa5-7d998ef75aa1 64725-2810 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR 20101228 ANDA ANDA089556 TYA Pharmaceuticals FLUPHENAZINE HYDROCHLORIDE 2.5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 64725-2957_26fe7a22-53d6-4b55-b20f-d88c0f7f75b6 64725-2957 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 TYA Pharmaceuticals CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 64725-3004_3cd86690-cc3e-47ae-bcc1-2a2690d45ed4 64725-3004 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 TYA Pharmaceuticals CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64725-3005_3cd86690-cc3e-47ae-bcc1-2a2690d45ed4 64725-3005 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 TYA Pharmaceuticals CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64725-3159_5b3c9704-3969-4194-8861-afdf5b27491a 64725-3159 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20111024 ANDA ANDA201588 TYA Pharmaceuticals OLANZAPINE 10 mg/2mL Atypical Antipsychotic [EPC] 64725-3228_418efa18-077c-43db-9b9a-ce25d59d4e10 64725-3228 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 TYA Pharmaceuticals ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 64725-3339_bb523010-0b3c-46b5-832e-692539312f68 64725-3339 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 TYA Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 64725-3920_00a908e6-006f-489e-bf83-f565f9f320c2 64725-3920 HUMAN PRESCRIPTION DRUG Geodon ziprasidone mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20031223 NDA NDA020919 TYA Pharmaceuticals ZIPRASIDONE MESYLATE 20 mg/mL Atypical Antipsychotic [EPC] 64725-3925_d5ea54f6-0d98-44f1-8839-e81fa0515843 64725-3925 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071307 TYA Pharmaceuticals DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64725-3926_d5ea54f6-0d98-44f1-8839-e81fa0515843 64725-3926 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071321 TYA Pharmaceuticals DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64725-4005_bd525ac0-d234-4a1d-936a-7c485882b41f 64725-4005 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 TYA Pharmaceuticals CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 64725-4067_782770e7-b6bd-4ed0-b7b7-99efc7b392cd 64725-4067 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071994 TYA Pharmaceuticals PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 64725-4111_cb714702-6d2b-4987-8045-3586baf12337 64725-4111 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20060905 ANDA ANDA040684 TYA Pharmaceuticals PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64725-4887_ced3e7f6-f45e-4010-bc4f-96fa860f5b90 64725-4887 HUMAN PRESCRIPTION DRUG Sterile Water WATER INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110915 NDA NDA018801 TYA Pharmaceuticals WATER 1 mL/mL 64725-5150_5d172892-ed60-4914-934b-74c9771a2d5b 64725-5150 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 TYA Pharmaceuticals LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 64725-5307_e2d3bab5-9ad3-4469-81a1-b6fda90d0067 64725-5307 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19730919 ANDA ANDA083426 TYA Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 64725-5375_1bb4e48b-8113-4789-a602-377dbf517c8b 64725-5375 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 TYA Pharmaceuticals DOXEPIN HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 64725-5400_b33bdf2c-8947-4d30-b72f-1364a018446c 64725-5400 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 TYA Pharmaceuticals LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 64725-5440_bee80872-6005-48dd-b96e-de49ba1610a0 64725-5440 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19770214 ANDA ANDA062031 TYA Pharmaceuticals DOXYCYCLINE HYCLATE 100 mg/1 64725-5620_bae49238-5562-46cc-b369-88245b27e91c 64725-5620 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071136 TYA Pharmaceuticals DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64725-5768_a611a26f-3423-40f9-a498-23ccd3e1122c 64725-5768 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 TYA Pharmaceuticals OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 64725-5790_b6f855b9-e909-4163-b6c9-892239ae2a07 64725-5790 HUMAN PRESCRIPTION DRUG PROAIR HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20121203 NDA NDA021457 TYA Pharmaceuticals ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 64725-5895_0f3e08a2-667b-48cf-b9ce-2ca878a74081 64725-5895 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 19971020 ANDA ANDA074612 TYA Pharmaceuticals NICOTINE 14 mg/24h 64725-5896_f7ac6da1-10d4-46d7-99c4-40818d97c911 64725-5896 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 19971020 ANDA ANDA074612 TYA Pharmaceuticals NICOTINE 21 mg/24h 64725-5914_298c7401-c635-4aa7-8efd-f5df0a90008e 64725-5914 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084112 TYA Pharmaceuticals CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 64725-5916_298c7401-c635-4aa7-8efd-f5df0a90008e 64725-5916 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084114 TYA Pharmaceuticals CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 64725-6044_9b3bd7a5-718a-4dd9-a908-4fa279c94621 64725-6044 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 TYA Pharmaceuticals LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64725-7544_e57024b0-ec2c-4e78-9294-646374b41871 64725-7544 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090783 TYA Pharmaceuticals DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 64725-7915_a4a288bd-5325-40f0-a03f-abb9b68b609c 64725-7915 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 OTC MONOGRAPH NOT FINAL part343 TYA Pharmaceuticals IBUPROFEN 200 mg/1 64725-8000_86ddf799-88d3-4d05-ae29-34e13a89cd22 64725-8000 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 TYA Pharmaceuticals ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] 64725-8031_ba0c7c30-0246-4de1-82f6-3208baadda05 64725-8031 HUMAN PRESCRIPTION DRUG Glucagon glucagon KIT 19990301 NDA NDA020928 TYA Pharmaceuticals 64725-8166_bf422cc2-9c69-4cf2-9a5b-22adee95ccf6 64725-8166 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 TYA Pharmaceuticals QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 64735-010_500fcd34-2b8b-42ac-9ee0-dc90e7d5a690 64735-010 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205712 Air Liquide Healthcare America Corporation OXYGEN 99 L/100L 64735-011_71a14136-8e51-4ad1-8710-decb6ab4879f 64735-011 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205712 Air Liquide Healthcare America Corporation OXYGEN 99 L/100L 64735-020_780ada88-3f29-44c5-8c44-fb2f1cc3aef0 64735-020 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205713 Air Liquide Healthcare America Corporation NITROGEN 99 L/100L 64735-021_1853c4ee-bf32-4c8a-be49-6576ebcc33e9 64735-021 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205713 Air Liquide Healthcare America Corporation NITROGEN 99 L/100L 64735-022_86414780-f026-421c-9a3c-ed78bf1d0083 64735-022 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205713 Air Liquide Healthcare America Corporation NITROGEN 99 L/100L 64735-030_9fcf3e30-349e-43a9-8f20-9d40ea34374c 64735-030 HUMAN PRESCRIPTION DRUG HELIUM HELIUM GAS RESPIRATORY (INHALATION) 19600101 NDA NDA206026 Air Liquide Healthcare America Corporation HELIUM 99 L/100L 64735-040_236e4586-d9aa-4868-9142-548dd15ce6a0 64735-040 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205704 Air Liquide Healthcare America Corporation NITROUS OXIDE 99 L/100L 64735-041_8ef525aa-a792-4797-8a4c-e647866a8461 64735-041 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205704 Air Liquide Healthcare America Corporation NITROUS OXIDE 99 L/100L 64735-050_10c6d0b3-cf20-4328-b748-336c43122bc0 64735-050 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205764 Air Liquide Healthcare America Corporation CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 64735-060_f825b8ce-57e8-45ff-ae70-420e8057efb1 64735-060 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mixture Carbon Dioxide Oxygen Mixture GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Air Liquide Healthcare America Corporation CARBON DIOXIDE; OXYGEN 5; 95 L/100L; L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 64735-070_2c1e32b8-7d04-46a2-bffe-e5d541bb087a 64735-070 HUMAN PRESCRIPTION DRUG COMPRESSED GAS, OXIDIZING, N.O.S. OXYGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205712 Air Liquide Healthcare America Corporation OXYGEN 40 L/100L 64735-074_4ba48103-6eec-4d8d-b66b-e0049768c621 64735-074 HUMAN PRESCRIPTION DRUG COMPRESSED GAS, N.O.S. OXYGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205712 Air Liquide Healthcare America Corporation OXYGEN 20 L/100L 64735-080_7777e939-2a5d-4af2-918d-f1f80e317e0c 64735-080 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Air Liquide Healthcare America Corporation NITROGEN; OXYGEN 77; 23 L/100L; L/100L 64735-100_388a34eb-a60f-4618-b20c-db3204ab7016 64735-100 HUMAN PRESCRIPTION DRUG EZ-OX OXYGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205712 Air Liquide Healthcare America Corporation OXYGEN 99 L/100L 64735-101_2075df56-d462-4207-a599-ed867a0cf3dd 64735-101 HUMAN PRESCRIPTION DRUG EZ-OX PLUS OXYGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205712 Air Liquide Healthcare America Corporation OXYGEN 99 L/100L 64745-001_09ccc52f-c816-4423-9e1c-f1e4f4aa9f8d 64745-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS COPD-LLC Respiratory Services OXYGEN 99 L/100L 64760-006_aa632028-9cf7-4c73-b0de-5886eac4abd4 64760-006 HUMAN OTC DRUG hydropel sports dimethicone OINTMENT TOPICAL 20100720 OTC MONOGRAPH FINAL part347 Genesis Pharmaceutical DIMETHICONE 17 g/56.69g 64760-019_e07432b0-6bb2-47e5-a750-1df9cfe3629e 64760-019 HUMAN OTC DRUG Acnotex acne Treatment sulfur resorcinol LOTION TOPICAL 20110707 OTC MONOGRAPH FINAL part333D Genesis Pharmaceutical RESORCINOL; SULFUR 1.18; 4.73 mL/59.14mL; mL/59.14mL 64760-033_c07edb7a-dfd6-4d53-ac90-98a04b1d0c95 64760-033 HUMAN OTC DRUG Glytone Acne Facial Masque sulfur CREAM TOPICAL 20140512 OTC MONOGRAPH FINAL part333D Genesis Pharmaceutical, Inc. SULFUR 64 mg/g 64760-081_8baced96-1057-4557-8973-8db55261de3e 64760-081 HUMAN OTC DRUG Glytone acne treatment flesh tinted acne sulfur, resorcinol LOTION TOPICAL 20100525 OTC MONOGRAPH FINAL part333D Genesis Pharmaceutical, Inc. RESORCINOL; SULFUR 20; 80 mg/mL; mg/mL 64760-200_76e2579d-4813-4868-936a-963d2689c9c7 64760-200 HUMAN PRESCRIPTION DRUG Glytone Clarifying hydroquinone CREAM TOPICAL 20100401 UNAPPROVED DRUG OTHER Genesis Pharmaceutical, Inc. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 64760-202_d072fc85-656c-4f5f-ac1e-cb3fd49d8051 64760-202 HUMAN PRESCRIPTION DRUG Glytone Clarifying Hydroquinone GEL TOPICAL 20101109 UNAPPROVED DRUG OTHER Genesis Pharmaceutical, Inc. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 64760-203_5607d2fb-8ff5-4a20-afcc-19d5fa6bddc4 64760-203 HUMAN OTC DRUG Glytone Essentials Rejuvenate daily avobenzone, octinoxate LOTION TOPICAL 20100520 OTC MONOGRAPH FINAL part352 Genesis Pharmaceutical AVOBENZONE; OCTINOXATE 1.2; 4.2 mL/60mL; mL/60mL 64760-204_681828cd-4ed8-4b2b-aebf-f35dba341082 64760-204 HUMAN OTC DRUG Glytone essentials rejuvenate daily Avobenzone, octinoxate CREAM TOPICAL 20100520 OTC MONOGRAPH FINAL part352 Glytone AVOBENZONE; OCTINOXATE 1; 3 mL/50mL; mL/50mL 64760-205_ad1b97ea-27ac-4e74-afc9-04dfacf1f234 64760-205 HUMAN OTC DRUG Glytone acne cleansing toner salicylic acid SOLUTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333D Genesis Pharmaceutical, Inc. SALICYLIC ACID 4.8 g/240mL 64760-208_fb08a86b-2bca-499c-b2ea-736192f29614 64760-208 HUMAN OTC DRUG glytone retexturize body octinoxate, octisalate, oxybenzone LOTION TOPICAL 20100519 OTC MONOGRAPH NOT FINAL part352 Glytone OCTINOXATE; OCTISALATE; OXYBENZONE 18.75; 12.5; 7.5 mL/250mL; mL/250mL; mL/250mL 64760-209_5d18aa6c-fc60-44b5-a630-d0e2ec278bce 64760-209 HUMAN OTC DRUG Glytone Acne benzoyl peroxide GEL TOPICAL 20100301 OTC MONOGRAPH FINAL part333D Genesis Pharmaceutical, Inc. BENZOYL PEROXIDE 5.6 g/56g 64760-210_00607cfe-493e-4ac1-a606-c0c0373551b2 64760-210 HUMAN OTC DRUG Glytone Acne Facial Masque sulfur CREAM TOPICAL 20100301 20150713 OTC MONOGRAPH FINAL part333D Genesis Pharmaceutical, Inc. SULFUR 64 mg/g 64760-213_cefd9c36-cd8e-450a-b395-9c275b068c02 64760-213 HUMAN OTC DRUG Glytone Acne Back Salicylic acid SPRAY TOPICAL 20100401 OTC MONOGRAPH FINAL part333D Genesis Pharmaceutical, Inc. SALICYLIC ACID 20 mg/mL 64760-215_8a8b4cec-049f-428b-9d8a-b8662bac504d 64760-215 HUMAN OTC DRUG Glytone Suncare block sunscreen octinoxate, octisalate, xinc oxide LOTION TOPICAL 20100625 OTC MONOGRAPH FINAL part352 Genesis Pharmaceutical OCTINOXATE; OCTISALATE; ZINC OXIDE 9; 2.4; 9 mL/120mL; mL/120mL; mL/120mL 64760-219_19fcf049-b388-4396-b0e2-cc27bad1d70d 64760-219 HUMAN OTC DRUG Glytone acne treatment facial cleanser salicylic acid LIQUID TOPICAL 20100101 OTC MONOGRAPH FINAL part358H Glytone SALICYLIC ACID 4 mL/200mL 64760-229_05181c48-6eda-4012-87d5-a0142ba36758 64760-229 HUMAN OTC DRUG Glytone skin bleaching fading hydroquinone LOTION TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part358A Genesis Pharmaceutical, Inc. HYDROQUINONE 20 mg/mL 64760-300_e9e0428a-907d-47af-a67e-34c77194cf43 64760-300 HUMAN OTC DRUG Glytone Acne salicylic acid LOTION TOPICAL 20101012 OTC MONOGRAPH FINAL part333D Genesis Pharmaceutical, Inc. SALICYLIC ACID 10 mg/mL 64760-301_737bcf3a-2737-4be8-b8b7-097eb984f9aa 64760-301 HUMAN OTC DRUG Glytone acne self cleanser salicylic acid AEROSOL, FOAM TOPICAL 20101012 OTC MONOGRAPH FINAL part333D Genesis SALICYLIC ACID .5 mL/100mL 64760-302_22eb3861-899b-456c-9167-83431c233d8c 64760-302 HUMAN OTC DRUG Glytone acne 3P benzoyl peroxide GEL TOPICAL 20101015 OTC MONOGRAPH NOT FINAL part333D Genesis Pharmaceuticals BENZOYL PEROXIDE 3 mL/60mL 64760-401_e6fa580b-51ff-4ef9-afbd-caa764539645 64760-401 HUMAN PRESCRIPTION DRUG Glytone Clarifying SunVanish with Sunscreen Hydroquinone CREAM TOPICAL 20120613 UNAPPROVED DRUG OTHER Genesis Pharmaceutical, Inc. AVOBENZONE; HYDROQUINONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 20; 40; 75; 18.6; 50 mg/g; mg/g; mg/g; mg/g; mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 64760-408_0e45b33d-ff71-4c2c-80d3-75687c31b43f 64760-408 HUMAN OTC DRUG Glytone Body Octinoxate, Oxybenzone, Avobenzene, Octocrylene LOTION TOPICAL 20120612 OTC MONOGRAPH FINAL part352 Genesis Pharmaceutical AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 7.1; 26.63; 6.6; 10.65 mL/355mL; mL/355mL; mL/355mL; mL/355mL 64762-861_3702b6c1-6071-40e9-8fc8-1a3e5c7f6ffe 64762-861 HUMAN OTC DRUG NBB Cherry Zinc Gluconate, Zinc Oxide, and Sambucus Nigra Flower TABLET, ORALLY DISINTEGRATING ORAL 20091104 UNAPPROVED HOMEOPATHIC Dynamic Pharmaceuticals Inc. SAMBUCUS NIGRA FLOWER; ZINC GLUCONATE; ZINC OXIDE 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 64762-862_c4b19477-d349-49ae-9cad-167ab21899b1 64762-862 HUMAN OTC DRUG NBB ZINC OXIDE, ZINC GLUCONATE, AND SAMBUCUS NIGRA FLOWERING TOP SPRAY, METERED ORAL 20100601 OTC MONOGRAPH FINAL part341 Dynamic Pharmaceuticals Inc. SAMBUCUS NIGRA FLOWERING TOP; ZINC GLUCONATE; ZINC OXIDE .05; 12.42; .25 mg/mL; mg/mL; mg/mL 64762-864_87057c78-4215-4840-a11b-82d7aa9f66e3 64762-864 HUMAN OTC DRUG Oxymetazoline Hydrochloride Oxymetazoline Hydrochloride SPRAY, METERED NASAL 20091104 OTC MONOGRAPH FINAL part341 Dynamic Pharmaceuticals OXYMETAZOLINE HYDROCHLORIDE .2 mg/.4mL 64762-865_0e55c145-6fc7-4800-9082-0e25f6a2161a 64762-865 HUMAN OTC DRUG Oxymetazoline Hydrochloride Oxymetazoline Hydrochloride SPRAY, METERED NASAL 20091104 OTC MONOGRAPH FINAL part341 Dynamic Pharmaceuticals OXYMETAZOLINE HYDROCHLORIDE .2 mg/.4mL 64762-870_c9b3921f-277f-48c3-8816-aebbeb1754ff 64762-870 HUMAN OTC DRUG NBB Citrus Zinc Gluconate, Zinc Oxide, and Sambucus Nigra Flower TABLET, ORALLY DISINTEGRATING ORAL 20091104 UNAPPROVED HOMEOPATHIC Dynamic Pharmaceuticals Inc. SAMBUCUS NIGRA FLOWER; ZINC GLUCONATE; ZINC OXIDE 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 64762-871_520e00c4-69d8-444e-9da0-8d965fad158a 64762-871 HUMAN OTC DRUG NBE ZINC GLUCONATE and ZINC ACETATE SPRAY, METERED ORAL 20100930 OTC MONOGRAPH FINAL part347 Dynamic Pharmaceuticals Inc. ZINC ACETATE; ZINC GLUCONATE .46; 12.26 mg/mL; mg/mL 64762-873_789d4fd7-b279-4f6f-ae19-4eced611b7b3 64762-873 HUMAN OTC DRUG NBE Citrus Cold Remedy Fast Melting (Rite Aid) Zinc Acetate and Zinc Gluconate TABLET, ORALLY DISINTEGRATING ORAL 20101004 UNAPPROVED HOMEOPATHIC Dynamic Pharmaceuticals Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 64762-874_2ecb6196-4b51-4c44-9b2e-08427183b629 64762-874 HUMAN OTC DRUG NBE Cherry Cold Remedy Fast Melting (Rite Aid) Zinc Acetate and Zinc Gluconate TABLET, ORALLY DISINTEGRATING ORAL 20101004 UNAPPROVED HOMEOPATHIC Dynamic Pharmaceuticals Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 64762-884_f4acd8a0-fe19-4eed-800a-8f11363129c9 64762-884 HUMAN OTC DRUG NBE Cool Mint Cold Remedy Fast Melting ZINC GLUCONATE LOZENGE ORAL 20110801 UNAPPROVED HOMEOPATHIC Dynamic Pharmaceuticals Inc. ZINC GLUCONATE 1 [hp_X]/1 64763-099_19e38385-389e-4aad-ab03-1bf69f0fbd6d 64763-099 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20020101 UNAPPROVED MEDICAL GAS Johnson Drug Company, Inc OXYGEN 99 L/100L 64764-046_58d4472b-78cc-4815-aa1f-ab572f40838a 64764-046 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole CAPSULE, DELAYED RELEASE ORAL 19950510 NDA NDA020406 Takeda Pharmaceuticals America, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 64764-080_a9d6c65d-5045-40f2-a7fd-6aaf29d10ec9 64764-080 HUMAN PRESCRIPTION DRUG Amitiza lubiprostone CAPSULE, GELATIN COATED ORAL 20060131 NDA NDA021908 Takeda Pharmaceuticals America, Inc. LUBIPROSTONE 8 ug/1 Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] 64764-119_78b5bab2-9303-438b-8b3a-83c7950ff062 64764-119 HUMAN PRESCRIPTION DRUG Colcrys Colchicine TABLET, FILM COATED ORAL 20090901 NDA NDA022352 Takeda Pharmaceuticals America, Inc. COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 64764-121_95b44edb-bd6f-471b-a1c7-44694551ecae 64764-121 HUMAN PRESCRIPTION DRUG OSENI alogliptin and pioglitazone TABLET, FILM COATED ORAL 20130125 NDA NDA022426 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 12.5; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 64764-123_95b44edb-bd6f-471b-a1c7-44694551ecae 64764-123 HUMAN PRESCRIPTION DRUG OSENI alogliptin and pioglitazone TABLET, FILM COATED ORAL 20130125 NDA NDA022426 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 12.5; 30 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 64764-124_95b44edb-bd6f-471b-a1c7-44694551ecae 64764-124 HUMAN PRESCRIPTION DRUG OSENI alogliptin and pioglitazone TABLET, FILM COATED ORAL 20130125 NDA NDA022426 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 12.5; 45 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 64764-125_d74fabc5-733f-4fbf-ad1c-d23fae6802fd 64764-125 HUMAN PRESCRIPTION DRUG Nesina alogliptin TABLET, FILM COATED ORAL 20130125 NDA NDA022271 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE 12.5 mg/1 64764-151_352f5dd8-4c3e-4e8e-8167-bf383bd95dd6 64764-151 HUMAN PRESCRIPTION DRUG Actos pioglitazone TABLET ORAL 19990715 NDA NDA021073 Takeda Pharmaceuticals America, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 64764-155_3303d858-3829-44e6-8504-2aa186955b74 64764-155 HUMAN PRESCRIPTION DRUG Actoplus Met pioglitazone and metformin hydrochloride TABLET, FILM COATED ORAL 20050829 NDA NDA021842 Takeda Pharmaceuticals America, Inc. METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 64764-158_3303d858-3829-44e6-8504-2aa186955b74 64764-158 HUMAN PRESCRIPTION DRUG Actoplus Met pioglitazone and metformin hydrochloride TABLET, FILM COATED ORAL 20050829 NDA NDA021842 Takeda Pharmaceuticals America, Inc. METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 64764-171_2c29ebcc-bbea-4bd4-a5de-9ca9b8c10834 64764-171 HUMAN PRESCRIPTION DRUG Dexilant dexlansoprazole CAPSULE, DELAYED RELEASE ORAL 20100412 NDA NDA022287 Takeda Pharmaceuticals America, Inc. DEXLANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 64764-175_2c29ebcc-bbea-4bd4-a5de-9ca9b8c10834 64764-175 HUMAN PRESCRIPTION DRUG Dexilant dexlansoprazole CAPSULE, DELAYED RELEASE ORAL 20100412 NDA NDA022287 Takeda Pharmaceuticals America, Inc. DEXLANSOPRAZOLE 60 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 64764-240_a9d6c65d-5045-40f2-a7fd-6aaf29d10ec9 64764-240 HUMAN PRESCRIPTION DRUG Amitiza lubiprostone CAPSULE, GELATIN COATED ORAL 20060131 NDA NDA021908 Takeda Pharmaceuticals America, Inc. LUBIPROSTONE 24 ug/1 Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] 64764-250_d74fabc5-733f-4fbf-ad1c-d23fae6802fd 64764-250 HUMAN PRESCRIPTION DRUG Nesina alogliptin TABLET, FILM COATED ORAL 20130125 NDA NDA022271 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE 25 mg/1 64764-251_95b44edb-bd6f-471b-a1c7-44694551ecae 64764-251 HUMAN PRESCRIPTION DRUG OSENI alogliptin and pioglitazone TABLET, FILM COATED ORAL 20130125 NDA NDA022426 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 25; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 64764-253_95b44edb-bd6f-471b-a1c7-44694551ecae 64764-253 HUMAN PRESCRIPTION DRUG OSENI alogliptin and pioglitazone TABLET, FILM COATED ORAL 20130125 NDA NDA022426 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 25; 30 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 64764-254_95b44edb-bd6f-471b-a1c7-44694551ecae 64764-254 HUMAN PRESCRIPTION DRUG OSENI alogliptin and pioglitazone TABLET, FILM COATED ORAL 20130125 NDA NDA022426 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 25; 45 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 64764-300_6e94621c-1a95-4af9-98d1-52b9e6f1949c 64764-300 HUMAN PRESCRIPTION DRUG Entyvio vedolizumab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140520 BLA BLA125476 Takeda Pharmaceuticals America, Inc. VEDOLIZUMAB 300 mg/5mL Integrin Receptor Antagonist [EPC],Integrin Receptor Antagonists [MoA] 64764-301_352f5dd8-4c3e-4e8e-8167-bf383bd95dd6 64764-301 HUMAN PRESCRIPTION DRUG Actos pioglitazone TABLET ORAL 19990715 NDA NDA021073 Takeda Pharmaceuticals America, Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 64764-302_66142d86-a539-4c5e-9a08-c9fd97605e19 64764-302 HUMAN PRESCRIPTION DRUG Duetact pioglitazone and glimepiride TABLET ORAL 20060728 NDA NDA021925 Takeda Pharmaceuticals America, Inc. GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE 2; 30 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 64764-304_66142d86-a539-4c5e-9a08-c9fd97605e19 64764-304 HUMAN PRESCRIPTION DRUG Duetact pioglitazone and glimepiride TABLET ORAL 20060728 NDA NDA021925 Takeda Pharmaceuticals America, Inc. GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE 4; 30 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 64764-310_df3a2f97-8ec8-47bb-8cb2-08cd0118e775 64764-310 HUMAN PRESCRIPTION DRUG Actoplus Met XR pioglitazone and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100611 NDA NDA022024 Takeda Pharmaceuticals America, Inc. METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 1000; 30 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 64764-335_c953d30e-0172-491a-b227-36b1636b6ad2 64764-335 HUMAN PRESCRIPTION DRUG KAZANO alogliptin and metformin hydrochloride TABLET, FILM COATED ORAL 20130125 NDA NDA203414 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE 12.5; 500 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 64764-337_c953d30e-0172-491a-b227-36b1636b6ad2 64764-337 HUMAN PRESCRIPTION DRUG KAZANO alogliptin and metformin hydrochloride TABLET, FILM COATED ORAL 20130125 NDA NDA203414 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE 12.5; 1000 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 64764-451_352f5dd8-4c3e-4e8e-8167-bf383bd95dd6 64764-451 HUMAN PRESCRIPTION DRUG Actos pioglitazone TABLET ORAL 19990715 NDA NDA021073 Takeda Pharmaceuticals America, Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 64764-510_df3a2f97-8ec8-47bb-8cb2-08cd0118e775 64764-510 HUMAN PRESCRIPTION DRUG Actoplus Met XR pioglitazone and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100611 NDA NDA022024 Takeda Pharmaceuticals America, Inc. METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 1000; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 64764-541_58d4472b-78cc-4815-aa1f-ab572f40838a 64764-541 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole CAPSULE, DELAYED RELEASE ORAL 19950510 NDA NDA020406 Takeda Pharmaceuticals America, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 64764-543_58d4472b-78cc-4815-aa1f-ab572f40838a 64764-543 HUMAN PRESCRIPTION DRUG Prevacid SoluTab lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20020830 NDA NDA021428 Takeda Pharmaceuticals America, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 64764-544_58d4472b-78cc-4815-aa1f-ab572f40838a 64764-544 HUMAN PRESCRIPTION DRUG Prevacid SoluTab lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20020830 NDA NDA021428 Takeda Pharmaceuticals America, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 64764-550_cc70d6dd-e54b-483d-83f5-762a6cce455a 64764-550 HUMAN PRESCRIPTION DRUG Brintellix vortioxetine TABLET, FILM COATED ORAL 20131002 NDA NDA204447 Takeda Pharmaceuticals America, Inc. VORTIOXETINE HYDROBROMIDE 5 mg/1 64764-560_cc70d6dd-e54b-483d-83f5-762a6cce455a 64764-560 HUMAN PRESCRIPTION DRUG Brintellix vortioxetine TABLET, FILM COATED ORAL 20131002 NDA NDA204447 Takeda Pharmaceuticals America, Inc. VORTIOXETINE HYDROBROMIDE 10 mg/1 64764-570_cc70d6dd-e54b-483d-83f5-762a6cce455a 64764-570 HUMAN PRESCRIPTION DRUG Brintellix vortioxetine TABLET, FILM COATED ORAL 20131002 NDA NDA204447 Takeda Pharmaceuticals America, Inc. VORTIOXETINE HYDROBROMIDE 15 mg/1 64764-580_cc70d6dd-e54b-483d-83f5-762a6cce455a 64764-580 HUMAN PRESCRIPTION DRUG Brintellix vortioxetine TABLET, FILM COATED ORAL 20131002 NDA NDA204447 Takeda Pharmaceuticals America, Inc. VORTIOXETINE HYDROBROMIDE 20 mg/1 64764-625_d74fabc5-733f-4fbf-ad1c-d23fae6802fd 64764-625 HUMAN PRESCRIPTION DRUG Nesina alogliptin TABLET, FILM COATED ORAL 20130125 NDA NDA022271 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE 6.25 mg/1 64764-677_a2a9c3f6-0674-41e7-8a36-25a8282991d8 64764-677 HUMAN PRESCRIPTION DRUG ULORIC febuxostat TABLET ORAL 20090213 NDA NDA021856 Takeda Pharmaceuticals America, Inc. FEBUXOSTAT 80 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 64764-702_f081eeed-7e1f-4526-b17c-98ba3ca9a17c 64764-702 HUMAN PRESCRIPTION DRUG PREVPAC lansoprazole, amoxicillin and clarithromycin KIT 19971202 NDA NDA050757 Takeda Pharmaceuticals America, Inc. 64764-805_74e295ed-af9b-4d5d-9505-ec565c56e9ea 64764-805 HUMAN PRESCRIPTION DRUG Rozerem ramelteon TABLET, FILM COATED ORAL 20050722 NDA NDA021782 Takeda Pharmaceuticals America, Inc. RAMELTEON 8 mg/1 Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA] 64764-844_58253113-9d39-4351-a131-97bb1037132f 64764-844 HUMAN PRESCRIPTION DRUG edarbi Azilsartan kamedoxomil TABLET ORAL 20110225 NDA NDA200796 Takeda Pharmaceuticals America, Inc. AZILSARTAN KAMEDOXOMIL 40 mg/1 Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE] 64764-884_58253113-9d39-4351-a131-97bb1037132f 64764-884 HUMAN PRESCRIPTION DRUG edarbi Azilsartan kamedoxomil TABLET ORAL 20110225 NDA NDA200796 Takeda Pharmaceuticals America, Inc. AZILSARTAN KAMEDOXOMIL 80 mg/1 Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE] 64764-890_ed2da3a6-0614-4bea-8e82-962cbaae6428 64764-890 HUMAN PRESCRIPTION DRUG CONTRAVE naltrexone hydrochloride and bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140910 NDA NDA200063 Takeda Pharmaceuticals America, Inc. BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE 90; 8 mg/1; mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA],Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 64764-918_a2a9c3f6-0674-41e7-8a36-25a8282991d8 64764-918 HUMAN PRESCRIPTION DRUG ULORIC febuxostat TABLET ORAL 20090213 NDA NDA021856 Takeda Pharmaceuticals America, Inc. FEBUXOSTAT 40 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 64764-944_f8f1da1e-47a1-43ad-b9e0-7dcf3a7552b7 64764-944 HUMAN PRESCRIPTION DRUG Edarbyclor azilsartan medoxomil and chlorthalidone TABLET ORAL 20111223 NDA NDA202331 Takeda Pharmaceuticals America, Inc. AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE 40; 12.5 mg/1; mg/1 Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 64764-994_f8f1da1e-47a1-43ad-b9e0-7dcf3a7552b7 64764-994 HUMAN PRESCRIPTION DRUG Edarbyclor azilsartan medoxomil and chlorthalidone TABLET ORAL 20111223 NDA NDA202331 Takeda Pharmaceuticals America, Inc. AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE 40; 25 mg/1; mg/1 Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 64768-2911_24e49bf6-d136-4c84-af8e-f9885bc2db61 64768-2911 HUMAN OTC DRUG Mustela Vitamin Barrier Zinc Oxide LOTION TOPICAL 20100719 OTC MONOGRAPH FINAL part347 Expanscience Laboratoires d/b/a Mustela ZINC OXIDE 5.5 g/55g 64768-2918_9f51131a-ef95-4a5e-b5b5-70e2f50bb429 64768-2918 HUMAN OTC DRUG Mustela Stelactiv Zinc Oxide LOTION TOPICAL 20100719 OTC MONOGRAPH FINAL part347 Expanscience Laboratoires d/b/a Mustela ZINC OXIDE 8.3 g/83g 64768-2919_dbfe9a61-e997-4755-9e92-3b1a1c9fcbdb 64768-2919 HUMAN OTC DRUG Mustela 50 Sunscreen TITANIUM DIOXIDE and ZINC OXIDE STICK TOPICAL 20130215 OTC MONOGRAPH NOT FINAL part352 Expanscience Laboratories d/b/a Mustela TITANIUM DIOXIDE; ZINC OXIDE .852; .6674 g/14.2g; g/14.2g 64768-2920_953ffbac-a459-48f0-a1f8-0ff79e02723e 64768-2920 HUMAN OTC DRUG Mustela SPF 50 TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20130215 OTC MONOGRAPH NOT FINAL part352 Expanscience Laboratories d/b/a Mustela TITANIUM DIOXIDE; ZINC OXIDE 60; 47 mg/mL; mg/mL 64772-126_d545635d-21de-4221-a10b-baedeab31225 64772-126 HUMAN OTC DRUG DERMA GRAN Aluminium Hydroxide OINTMENT TOPICAL 20131114 OTC MONOGRAPH FINAL part331 Derma Sciences Canada, Inc. ALUMINUM HYDROXIDE .275 g/100g 64772-300_7ef17f63-6f4f-44a0-a89f-479ce9ee68da 64772-300 HUMAN OTC DRUG Primer Zinc Oxide, Calamine DRESSING TOPICAL 20100510 OTC MONOGRAPH FINAL part347 Derma Sciences Canada, Inc. FERRIC OXIDE RED; ZINC OXIDE; ZINC OXIDE .015; .985; 25 g/1; g/1; g/1 64772-302_3782c8e9-49e7-4f8a-af24-93c2201133e0 64772-302 HUMAN OTC DRUG Primer Zinc Oxide DRESSING TOPICAL 20100510 OTC MONOGRAPH FINAL part347 Derma Sciences Canada, Inc. ZINC OXIDE 25 g/1 64776-696_ff01f354-ad6b-414f-8d53-44d2b4912106 64776-696 HUMAN OTC DRUG Scent Killer Anti-Perspirant and Deodorant Odorless Formula Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20140408 OTC MONOGRAPH FINAL part350 Wildlife Research Center, Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 22 g/100g 64778-0213_a017c276-267f-4ff3-84eb-83113b94ff65 64778-0213 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second Sodium Fluoride GEL DENTAL 19991201 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/mL 64778-0214_2ec74fc5-58bc-462c-879e-653c36825968 64778-0214 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second Sodium Fluoride GEL DENTAL 19991001 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/mL 64778-0215_a148e480-6f09-41f3-9b81-595dd68c047b 64778-0215 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second Sodium Fluoride GEL DENTAL 19991001 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/mL 64778-0216_e2b60289-478e-4d88-bb80-f63471e31412 64778-0216 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second Sodium Fluoride GEL DENTAL 19991001 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/mL 64778-0217_90ea26cc-60a2-403a-853e-6db936166aff 64778-0217 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second Sodium Fluoride GEL DENTAL 20000301 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/mL 64778-0218_84631a8e-2f4e-43d1-88bb-e2faa5045695 64778-0218 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second Sodium Fluoride GEL DENTAL 20050401 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/mL 64778-0219_a1399c85-a5b1-490f-b38e-f15e0d579742 64778-0219 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second Sodium Fluoride GEL DENTAL 20050401 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/mL 64778-0236_3aacdc81-ac3a-459a-97e5-0203d030c424 64778-0236 HUMAN PRESCRIPTION DRUG DentiCare Denti-Pro Sodium Fluoride GEL DENTAL 19991103 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .02 g/mL 64778-0244_b2b081f6-f148-46dc-915e-6b1cd0f8dae7 64778-0244 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Rinse Chlorhexidine Gluconate Oral Rinse Chlorhexidine Gluconante LIQUID DENTAL 20060602 ANDA ANDA077789 AR Medicom Inc. CHLORHEXIDINE GLUCONATE .12 g/mL Decreased Cell Wall Integrity [PE] 64778-0373_e7161ee2-a6e2-4828-a80a-6046f0666b94 64778-0373 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Bubble Gum Sodium Fluoride AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/g 64778-0375_22878d8b-2e74-41e6-9c8c-5b8e7441b1a7 64778-0375 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Grape Sodium Fluoride AEROSOL, FOAM DENTAL 20030401 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/g 64778-0376_1104c26b-ae7d-475c-8bd8-3331d4bc122c 64778-0376 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Mint Sodium Fluoride AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/g 64778-0377_8aa88ec0-4973-4cd4-a529-c93f6b1a2524 64778-0377 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Orange Sodium Fluoride AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/g 64778-0378_e1e2a3f0-1849-4d43-b9f0-d573f5c44081 64778-0378 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Raspberry Sodium Fluoride AEROSOL, FOAM DENTAL 20050501 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/g 64778-0379_a3de89d7-7071-4a3f-89e8-f780ef617529 64778-0379 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Strawberry Sodium Fluoride AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/g 64778-0393_ff82566a-906a-4c3d-b5fa-7f22193733b9 64778-0393 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Bubblegum benzocaine, tetracaine hydrochloride GEL DENTAL 20000201 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE; TETRACAINE HYDROCHLORIDE .18; .02 g/g; g/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 64778-0394_0debe0b5-a32d-4206-808c-f4a5ce648612 64778-0394 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Cherry benzocaine, tetracaine hydrochloride GEL DENTAL 20000401 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE; TETRACAINE HYDROCHLORIDE .18; .02 g/g; g/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 64778-0396_641e77b9-a7d6-4715-84d6-b21e7c14fa60 64778-0396 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Mint benzocaine, tetracaine hydrochloride GEL DENTAL 20000201 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE; TETRACAINE HYDROCHLORIDE .18; .02 g/g; g/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 64778-0398_9109b9d5-693a-4983-aa2c-6fd951434767 64778-0398 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Raspberry benzocaine, tetracaine hydrochloride GEL DENTAL 20050401 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE; TETRACAINE HYDROCHLORIDE .18; .02 g/g; g/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 64778-0399_4776a475-535d-4bcf-b7d6-eb1d68094bd2 64778-0399 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Strawberry benzocaine, tetracaine hydrochloride GEL DENTAL 20000201 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE; TETRACAINE HYDROCHLORIDE .18; .02 g/g; g/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 64778-0446_0091301e-6476-40e3-b2c0-91d1117e922f 64778-0446 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse Sodium Fluoride LIQUID DENTAL 20010301 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .02 g/mL 64778-0448_6504d1c4-47ed-492d-adef-be9e5ca48868 64778-0448 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse Berry Sodium Fluoride LIQUID DENTAL 20010601 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .02 g/mL 64778-0493_59ca3bac-a5c5-4b23-a748-a75eb657c29b 64778-0493 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Bubblegum benzocaine OINTMENT DENTAL 20050728 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE .2 g/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 64778-0494_d146d72c-01b8-46ce-a578-1015a6e54c6e 64778-0494 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Cherry benzocaine OINTMENT DENTAL 20050728 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE .2 g/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 64778-0496_c67827c0-1d9c-4824-aeda-e30f4976c3d0 64778-0496 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Mint benzocaine OINTMENT DENTAL 20050728 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE .2 g/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 64778-0498_c329a057-f165-44c9-a0f8-adb29269b9d7 64778-0498 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Raspberry benzocaine OINTMENT DENTAL 20050728 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE .2 g/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 64778-0499_fca653cb-59c6-47e9-bb50-11e60da686ac 64778-0499 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Strawberry benzocaine OINTMENT DENTAL 20050728 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE .2 g/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 64778-1212_765dd81a-0b10-4707-8d48-f044202b96c3 64778-1212 HUMAN PRESCRIPTION DRUG DentiCare Pro-Gel Sodium Fluoride GEL DENTAL 20050401 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/mL 64778-1213_e9ca9521-00df-4cb2-b26c-1962f17ce6bf 64778-1213 HUMAN PRESCRIPTION DRUG DentiCare Pro-Gel Sodium Fluoride GEL DENTAL 20050401 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/mL 64778-1231_8c47c049-4b10-4b7b-836c-12229c6ee059 64778-1231 HUMAN PRESCRIPTION DRUG DentiCare Pro-Gel Sodium Fluoride GEL DENTAL 19991103 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .02 g/mL 64778-1232_d026177c-467e-4c93-b356-9f39d3c17b71 64778-1232 HUMAN PRESCRIPTION DRUG DentiCare Pro-Gel Sodium Fluoride GEL DENTAL 19991103 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .02 g/mL 64778-1233_66546f71-3ac0-4da0-b293-a6fbd20af855 64778-1233 HUMAN PRESCRIPTION DRUG DentiCare Pro-Gel Sodium Fluoride GEL DENTAL 19991103 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .02 g/mL 64778-1371_93fca716-8acf-4403-a674-76729d45135a 64778-1371 HUMAN PRESCRIPTION DRUG DentiCare Pro-Foam Sodium Fluoride AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/g 64778-1372_49a40936-2fe8-4510-93e2-c22f1c04daea 64778-1372 HUMAN PRESCRIPTION DRUG DentiCare Pro-Foam Sodium Fluoride AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/g 64778-1373_a24a83eb-3f91-496a-b78a-95b5a0b3db76 64778-1373 HUMAN PRESCRIPTION DRUG Denti-Care Topical Fluoride Foam Bubble Gum Fluoride Ions AEROSOL, FOAM DENTAL 20110209 UNAPPROVED DRUG OTHER AR Medicom Inc HYDROFLUORIC ACID; SODIUM FLUORIDE .01; .0176 g/g; g/g 64778-1375_ab845c6e-6c51-46fa-914a-4f2420863f53 64778-1375 HUMAN PRESCRIPTION DRUG Denti-Care Topical Fluoride Foam Grape Fluoride Ions AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AR Medicom Inc HYDROFLUORIC ACID; SODIUM FLUORIDE .01; .0176 g/g; g/g 64778-1377_caee8eb8-3571-4e9f-80cc-2efdec2ad091 64778-1377 HUMAN PRESCRIPTION DRUG Denti-Care Topical Fluoride Foam Orange Fluoride Ions AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AR Medicom Inc HYDROFLUORIC ACID; SODIUM FLUORIDE .01; .0176 g/g; g/g 64778-1378_0ef082fc-d68a-432b-adbf-dc67a578f3ad 64778-1378 HUMAN PRESCRIPTION DRUG Denti-Care Topical Fluoride Foam Raspberry Fluoride Ions AEROSOL, FOAM DENTAL 20110209 UNAPPROVED DRUG OTHER AR Medicom Inc HYDROFLUORIC ACID; SODIUM FLUORIDE .01; .0176 g/g; g/g 64778-1379_3a3abc74-46e5-46d2-8d17-f47284902078 64778-1379 HUMAN PRESCRIPTION DRUG Denti-Care Topical Sodium Fluoride Strawberry Sodium Fluoride AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AR Medicom Inc HYDROFLUORIC ACID; SODIUM FLUORIDE .01; .0176 g/g; g/g 64778-1443_094d714e-d8f2-4622-87d0-d23b1671c703 64778-1443 HUMAN PRESCRIPTION DRUG DentiCare Pro-Rinse Sodium Fluoride RINSE DENTAL 20010601 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .02 g/mL 64786-233_d6be5945-cb41-4eef-a133-43cb0910936a 64786-233 HUMAN OTC DRUG First Force TRICLOSAN SOAP TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part333E Basic Packaging Industries Inc. TRICLOSAN .1 g/100mL 64792-0001_396b2ae4-077f-4b81-ab90-47e21788a8f7 64792-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19991109 UNAPPROVED MEDICAL GAS Home Health Resource OXYGEN 995 mL/L 64809-100_fbc0541f-5b16-440e-b149-a9e277f60826 64809-100 HUMAN OTC DRUG Sperian Eyesaline Emergency Eyewash Purified water LIQUID OPHTHALMIC 20110906 OTC MONOGRAPH FINAL part349 Sperian Eye & Face Protection Inc WATER 98.6 mL/100mL 64809-101_9ed6165e-5e85-4320-8dcb-5d6798a4283d 64809-101 HUMAN OTC DRUG Sperian Eyesaline Eyewash Water LIQUID OPHTHALMIC 20110907 OTC MONOGRAPH FINAL part349 Sperian Eye & Face Protection Inc WATER 99.8 mL/100mL 64809-104_b17e819f-af64-4de7-9fd9-7a7ed703ebd2 64809-104 HUMAN OTC DRUG Eyesaline Concentrate Water LIQUID OPHTHALMIC 20110908 OTC MONOGRAPH FINAL part349 Sperian Eye & Face Protection Inc. WATER 92.2 mL/100mL 64809-105_eff94695-403e-4669-9bd1-f2cb05ec9b31 64809-105 HUMAN OTC DRUG Water Additive Purified Water LIQUID OPHTHALMIC 20120201 OTC MONOGRAPH FINAL part349 Sperian Eye & Face Protection Inc WATER 99 mL/100mL 64841-773_c6309c8b-59c7-4d4c-b056-bc300786313e 64841-773 HUMAN OTC DRUG Med Plus ALCOHOL AEROSOL, FOAM TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part333 Handi-Clean Products, Inc. ALCOHOL 620 mg/g 64850-440_42ecacde-6859-47c6-ba44-13fb4f3b5448 64850-440 HUMAN PRESCRIPTION DRUG PHENDIMETRAZINE TARTRATE Phendimetrazine Tartrate TABLET ORAL 20121120 ANDA ANDA040762 Elite Laboratories, Inc PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 64850-810_0b7ad9c0-9e1e-4a69-802b-28f44267e34d 64850-810 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20140501 ANDA ANDA040190 Elite Laboratories, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 64854-035_79eec606-043c-42dc-b8bd-1c7b10fee12a 64854-035 HUMAN OTC DRUG BriteSmile Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20060826 OTC MONOGRAPH FINAL part355 Discus Dental, LLC SODIUM FLUORIDE 2.4 mg/g 64861-303_5b97f373-690c-4a84-b3f6-24353f50f771 64861-303 HUMAN OTC DRUG Omeprazole Delayed Release Omeprazole TABLET, DELAYED RELEASE ORAL 20080301 NDA NDA022032 Dexcel Ltd. OMEPRAZOLE 20 mg/1 64889-0001_cef73f07-0583-49c9-b68c-9bcded1b216e 64889-0001 HUMAN PRESCRIPTION DRUG Oxygen 64889-0001 Oxygen GAS RESPIRATORY (INHALATION) 20130325 UNAPPROVED MEDICAL GAS Advanced Oxy-Med Services Inc OXYGEN 99 L/100L 64893-001_65bf29b4-94e2-4922-88eb-93687f70594b 64893-001 HUMAN OTC DRUG Binaca Anticavity Flouride Peppermint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20100504 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc SODIUM MONOFLUOROPHOSPHATE .76 g/100g 64893-030_e3614f3e-9eb6-480b-b948-73f102f18331 64893-030 HUMAN OTC DRUG Infectiguard Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120627 OTC MONOGRAPH NOT FINAL part333E Dr. Fresh, Inc. ALCOHOL 62 mL/100mL 64893-100_613a2b8a-2b50-4691-be5b-e2d595daa72d 64893-100 HUMAN OTC DRUG Infectiguard Fast Acting Antiseptic Hand Sanitizer ALCOHOL GEL TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Dr. Fresh, Inc. ALCOHOL 62 mL/100mL 64893-200_98d9d0b5-431b-4690-8cac-d6df2af0c5fb 64893-200 HUMAN OTC DRUG infectiguard Fast Acting Antiseptic Hand Sanitizer with Moisturizer ALCOHOL GEL TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Dr. Fresh, Inc. ALCOHOL 62 mL/100mL 64893-210_1545b5f0-3f3e-4146-ad51-2e5446461657 64893-210 HUMAN OTC DRUG DR. Fresh Dailies Travel SODIUM FLUORIDE PASTE DENTAL 20100716 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .243 g/100g 64893-300_f3bbe7b8-e294-460c-8dbb-7f9a6f1adb7f 64893-300 HUMAN OTC DRUG Firefly Mouth Swoosh Anti-Cavity Fluoride Rinse SODIUM FLUORIDE LIQUID DENTAL 20100902 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .05 mL/100mL 64893-310_e0544c72-f88a-48a4-addb-c78237a5daf1 64893-310 HUMAN OTC DRUG Hello Kitty SODIUM FLUORIDE PASTE DENTAL 20110620 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .243 g/100g 64893-320_677ebe7e-c802-45de-bc8e-ebc014c047b5 64893-320 HUMAN OTC DRUG Dr. Fresh Oral Care SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100504 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc SODIUM MONOFLUOROPHOSPHATE .76 g/100g 64893-331_5b3cad98-ec6d-4f18-8c42-16accf2caefb 64893-331 HUMAN OTC DRUG Spider Sense Spider-Man Pediatric SODIUM FLUORIDE PASTE DENTAL 20110621 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .243 g/100g 64893-365_908674e1-b3fe-4e62-83b0-a2aa9ad55fbe 64893-365 HUMAN OTC DRUG Firefly Angry Birds Fluoride SODIUM FLUORIDE AEROSOL, FOAM DENTAL 20120529 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .243 mL/100mL 64893-383_8208d780-6bc5-43fc-963d-0272b25e4c77 64893-383 HUMAN OTC DRUG Baby SensiGel BENZOCAINE GEL TOPICAL 20111012 OTC MONOGRAPH NOT FINAL part356 Dr. Fresh, Inc BENZOCAINE 7.5 g/100g 64893-384_e3823561-828e-4e77-896d-60f1d682233f 64893-384 HUMAN OTC DRUG Baby SensiGel Night Time Formula BENZOCAINE GEL TOPICAL 20111007 OTC MONOGRAPH NOT FINAL part356 Dr. Fresh, Inc BENZOCAINE 10 g/100g 64893-385_7aea4dad-2c01-42d3-bb43-53a9697591ab 64893-385 HUMAN OTC DRUG SensiGel BENZOCAINE GEL TOPICAL 20110926 OTC MONOGRAPH NOT FINAL part356 Dr. Fresh, Inc. BENZOCAINE 20 g/100g 64893-400_bc8e0d2d-1e5c-45c9-ad58-1a57a509dd7c 64893-400 HUMAN OTC DRUG FIREFLY AntiCavity Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100603 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 64893-413_e537ba29-d109-47ee-9747-ae43358f0002 64893-413 HUMAN OTC DRUG Dr. Fresh Travel Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM MONOFLUOROPHOSPHATE 76 g/100g 64893-440_cd7549c0-4481-4252-9707-06cc02588e39 64893-440 HUMAN OTC DRUG SmileGuard Strawberry Shortcake Bubblegum SODIUM FLUORIDE MOUTHWASH ORAL 20111209 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .05 mL/100mL 64893-441_5fc87f98-ceab-412e-aeb4-9f2d6043eb87 64893-441 HUMAN OTC DRUG SmileGuard Spider Sense Spider-Man Bubblegum SODIUM FLUORIDE MOUTHWASH ORAL 20111209 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .05 mL/100mL 64893-481_97ac81d4-ce20-4a91-9b4e-6b626f9bb5bf 64893-481 HUMAN OTC DRUG Dr. Fresh Brush and Cover SODIUM FLUORIDE PASTE DENTAL 20110620 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .243 g/100g 64893-495_b798d802-1b11-4017-b7de-8631d2863951 64893-495 HUMAN OTC DRUG Smiley Gripper SODIUM FLUORIDE PASTE DENTAL 20110620 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .243 g/100g 64893-500_c8657a43-fdb6-4e90-a4f7-edbfc7804663 64893-500 HUMAN OTC DRUG Binaca Fluoride Anticavity Mouthwash SODIUM FLUORIDE LIQUID DENTAL 20100902 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .05 mL/100mL 64893-613_c8627830-7cd2-4597-a736-c08bbd3e5603 64893-613 HUMAN OTC DRUG FireFly SmileGuard Kids SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20110621 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 64893-700_178cc525-b119-4fff-ab40-27fac7600bda 64893-700 HUMAN OTC DRUG The Amazing SPIDER-MAN Hand Sanitizer Moisturizing With Vitamin E and Aloe ALCOHOL GEL TOPICAL 20101020 OTC MONOGRAPH NOT FINAL part333E Dr. Fresh, Inc. ALCOHOL 62 mL/100mL 64893-800_11fccd57-e168-4851-8981-3d573315526b 64893-800 HUMAN OTC DRUG SmileGuard Just 4 Me SODIUM FLUORIDE PASTE DENTAL 20110817 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .243 g/100g 64893-801_d9392825-e706-4563-81a8-0dca68ea5c97 64893-801 HUMAN OTC DRUG DR.Fresh Kids Pediatric SODIUM FLUORIDE PASTE DENTAL 20110817 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .243 g/100g 64893-802_8cbddfdb-d9f4-4d4a-b3e4-121e48c5adba 64893-802 HUMAN OTC DRUG FIREFLY Pediatric SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20110817 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 64893-901_8ca562c2-d24e-437f-9bcc-33a2b301fb78 64893-901 HUMAN OTC DRUG Barbie Striped Fluoride SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20120613 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .22 g/100g 64893-902_517a0531-f5eb-4efd-a7a2-7da3bd1eea42 64893-902 HUMAN OTC DRUG FIREFLY Barbie Fluoride Foam Bubblegum Flavor SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130301 OTC MONOGRAPH FINAL part355 Dr. Fresh LLC SODIUM FLUORIDE 2.43 mg/mL 64893-903_0d6abf8e-42b5-413f-a466-f3212cd5daf7 64893-903 HUMAN OTC DRUG FIREFLY MARVEL Ultimate SPIDER-MAN Fluoride Foam Bubblegum Flavor SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130301 OTC MONOGRAPH FINAL part355 Dr. Fresh LLC SODIUM FLUORIDE 2.43 mg/mL 64896-671_9f4b598b-6cf3-4341-9387-177cb8509af0 64896-671 HUMAN PRESCRIPTION DRUG ZOMIG Zolmitriptan TABLET ORAL 20120402 NDA NDA020768 Impax Laboratories, Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 64896-672_9f4b598b-6cf3-4341-9387-177cb8509af0 64896-672 HUMAN PRESCRIPTION DRUG ZOMIG Zolmitriptan TABLET ORAL 20120402 NDA NDA020768 Impax Laboratories, Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 64896-681_c2eb0cbc-aa84-4c41-8fd3-b4739b0b866a 64896-681 HUMAN PRESCRIPTION DRUG ZOMIG Zolmitriptan SPRAY, METERED NASAL 20120702 NDA NDA021450 Impax Laboratories, Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 64896-682_c2eb0cbc-aa84-4c41-8fd3-b4739b0b866a 64896-682 HUMAN PRESCRIPTION DRUG ZOMIG Zolmitriptan SPRAY, METERED NASAL 20131206 NDA NDA021450 Impax Laboratories, Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 64896-691_9f4b598b-6cf3-4341-9387-177cb8509af0 64896-691 HUMAN PRESCRIPTION DRUG ZOMIG ZMT Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20120702 NDA NDA021231 Impax Laboratories, Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 64896-692_9f4b598b-6cf3-4341-9387-177cb8509af0 64896-692 HUMAN PRESCRIPTION DRUG ZOMIG ZMT Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20120702 NDA NDA021231 Impax Laboratories, Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 64920-0001_0a1a1032-6a50-484e-b5dc-82e68aab7738 64920-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990426 UNAPPROVED MEDICAL GAS WHABA Medical, Inc. OXYGEN 99 L/100L 64922-233_9667306e-71fc-422e-a36d-785790fe47fa 64922-233 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS ADF Welding & Medical, Inc. OXYGEN 99 L/100L 64922-240_02da3b28-af17-4b5f-8b98-eeb0c0964be3 64922-240 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS ADF Welding & Medical, Inc. NITROGEN 99 L/100L 64932-1234_eba75f5d-d580-4812-be0a-407deac2e19a 64932-1234 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19770101 UNAPPROVED MEDICAL GAS Cape Medical Supply, Inc OXYGEN 99 L/100L 64942-0001_1a7a4065-c39c-44ca-8463-ee711b515fe3 64942-0001 HUMAN OTC DRUG Degree Women Nature Effects Orange Flower and Cranberry Antiperspirant and Deodorant STICK TOPICAL 20090901 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-0016_698dd490-cca8-4a28-aea6-d115790af9ed 64942-0016 HUMAN OTC DRUG Vaseline Pure Baby Petrolatum JELLY TOPICAL 20100318 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever PETROLATUM 99.96 g/100g 64942-0034_8d92dc88-ce59-4b8c-ac18-875053d7bbe1 64942-0034 HUMAN OTC DRUG Vaseline Pure Petrolatum JELLY TOPICAL 20100318 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever PETROLATUM 100 g/100g 64942-0053_c22f300e-1305-4642-8472-087d5c67fc21 64942-0053 HUMAN OTC DRUG Vaseline Lip Therapy Advanced Formula Petrolatum OINTMENT TOPICAL 20040120 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever PETROLATUM 100 g/100g 64942-0054_c5a028f5-1826-4b80-acaf-58e7a88f8a10 64942-0054 HUMAN OTC DRUG Vaseline Lip Therapy Cherry Petrolatum OINTMENT TOPICAL 20040120 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever PETROLATUM 100 g/100g 64942-0276_30c51f56-ed41-4057-8874-5279abe70ec5 64942-0276 HUMAN OTC DRUG Vaseline Petroleum Jelly Deep Moisture Petroleum CREAM TOPICAL 20071231 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever PETROLATUM 30 g/100g 64942-0634_bbcf52db-6251-4766-8589-943b9fc5966e 64942-0634 HUMAN OTC DRUG Degree for Men Extreme Blast Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-0675_d23783ca-00c7-4b64-a417-c42e594ad7c4 64942-0675 HUMAN OTC DRUG Degree for Men Sport Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-0689_541443a5-3ac6-4f06-9800-f316500940be 64942-0689 HUMAN OTC DRUG Axe Kilo Invisible Solid Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100113 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-0690_c1889727-4fdc-47e1-9d05-d904230256bc 64942-0690 HUMAN OTC DRUG Axe Essence Invisible Solid Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090324 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-0731_d04264c4-8967-48a3-8a33-3e77a30284a4 64942-0731 HUMAN OTC DRUG Axe Touch Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090324 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-0747_cec9104e-7abe-40ba-80dc-f00f90da1cbd 64942-0747 HUMAN OTC DRUG Suave Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090428 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.5 g/100g 64942-0774_f23351a1-7763-4cc6-b911-cfe662cc16be 64942-0774 HUMAN OTC DRUG Suave Fresh Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g 64942-0775_69a191f9-e120-4ab3-a3a0-ea2294cbccec 64942-0775 HUMAN OTC DRUG Suave Powder Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g 64942-0779_00090a78-f4df-47a0-aba4-fb30414aedb5 64942-0779 HUMAN OTC DRUG Degree UltraClear Pure Satin Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090428 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-0782_70b6158d-d36a-427a-92fe-f78f6eeebbf1 64942-0782 HUMAN OTC DRUG Degree Women UltraClear Pure Rain Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-0786_a8b62496-b537-4e3c-b22f-c1eca23ceb55 64942-0786 HUMAN OTC DRUG Degree for Men Cool Comfort Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-0810_368245ea-dac5-4543-9271-d23a3927e1fb 64942-0810 HUMAN OTC DRUG Axe Clix Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-0819_811f9139-cedb-4a25-9da3-e44bf2112626 64942-0819 HUMAN OTC DRUG Degree for Men Power Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-0824_2f2c60d2-98a6-434e-a300-2a86af8fc846 64942-0824 HUMAN OTC DRUG Degree UltraClear Pure Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100108 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-0831_1173f14d-b0b7-4dbb-93e7-c0dbfa68fc40 64942-0831 HUMAN OTC DRUG Degree Fresh Oxygen Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090428 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-0832_286e661f-d44a-4874-bf81-d516b52a7a7f 64942-0832 HUMAN OTC DRUG Degree Women Sheer Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-0836_fb37de77-33f9-4d24-947e-dc31e602383e 64942-0836 HUMAN OTC DRUG Degree Women Shower Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-0866_a3fbd2bf-bbf7-45a5-b998-877b6a04dbec 64942-0866 HUMAN OTC DRUG Degree for Men Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-0889_10d7fb09-5347-447a-8cff-d583cbac65b8 64942-0889 HUMAN OTC DRUG Dove Ultimate Go Fresh Cool Essentials Antiperspirant and Deodorant STICK TOPICAL 20091201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-0891_58bc974e-08c1-412c-ab3e-e527ef0fe9a9 64942-0891 HUMAN OTC DRUG Suave Pacific Breeze Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g 64942-0893_f1db4a00-7da2-4266-8918-1314a9ba2d8a 64942-0893 HUMAN OTC DRUG Suave Sweet Pea and Violet Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g 64942-0894_030e076c-d124-4ea5-bcea-ba6d62701a25 64942-0894 HUMAN OTC DRUG Suave Tropical Paradise Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g 64942-0902_d2785123-b187-4f69-8fde-4835dc8bbe46 64942-0902 HUMAN OTC DRUG Dove IS Original Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090414 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1007_cc573e9f-2768-487a-9e78-29d897f8ab84 64942-1007 HUMAN OTC DRUG Degree for Men Absolute Protection Cool Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090428 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.5 g/100g 64942-1010_fd3cc81c-641a-4e2e-a7a7-3a48ae1538bd 64942-1010 HUMAN OTC DRUG Dove Clinical Protection Original Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110907 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1013_ee115fc6-532d-4dc6-8c9e-683016bb1f8f 64942-1013 HUMAN OTC DRUG Degree Clinical Protection Shower Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1014_b90e316b-06ac-401d-b5d2-6d21de4cd7b9 64942-1014 HUMAN OTC DRUG Degree Clinical Protection Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1018_e8f2743f-a39e-465c-85f4-d1c26d63caa9 64942-1018 HUMAN OTC DRUG Dove IS Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20080305 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1022_428e4640-276c-49a4-ab81-36c0d13497cf 64942-1022 HUMAN OTC DRUG Dove IS Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20080305 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1031_31476bcc-21b6-471e-981d-5b8bf5516cbd 64942-1031 HUMAN OTC DRUG Axe Sharp Focus Invisible Solid Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090203 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-1035_f5036177-5219-4a5e-8d89-75c5c8db45b8 64942-1035 HUMAN OTC DRUG Degree Clinical Protection Sheer Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20091006 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1036_83261b15-a8cc-4b0f-adcf-64d5055b6ef8 64942-1036 HUMAN OTC DRUG Degree Clinical Protection Cool Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090122 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1037_9c1ce044-0dee-4f63-b92f-ad43b74ffece 64942-1037 HUMAN OTC DRUG Suave Clinical Protection Powder Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101124 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1038_69ad9419-ac48-494a-98be-db322f4d45db 64942-1038 HUMAN OTC DRUG Vaseline Intensive Rescue Clinical Therapy Fragrance Free DIMETHICONE LOTION TOPICAL 20080623 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever DIMETHICONE 1 g/100mL 64942-1044_d3eede6a-8600-4dde-bf56-d9b61fe03daa 64942-1044 HUMAN OTC DRUG Degree Clinical Protection Classic Romance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20081029 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1048_72da477e-c8fa-4656-80e1-1a4234162cdc 64942-1048 HUMAN OTC DRUG Vaseline Intensive Care Aloe Fresh Protecting Body Lotion SPF 15 LOTION TOPICAL 20081223 OTC MONOGRAPH FINAL part352 Conopco Inc. d/b/a Unilever OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 1; 3 mL/100mL; mL/100mL; mL/100mL 64942-1049_ca6289d2-41cd-41dd-a35a-f781cb8d77a9 64942-1049 HUMAN OTC DRUG Axe Armor AntiDandruff 2 in 1 Shampoo plus Conditioner SHAMPOO TOPICAL 20081223 OTC MONOGRAPH FINAL part358 Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL 64942-1050_685c8edd-d2ab-4fe1-b164-24388941d276 64942-1050 HUMAN OTC DRUG Suave Men 2 in 1 Dandruff Shampoo plus Conditioner SHAMPOO TOPICAL 20090122 OTC MONOGRAPH FINAL part358 Conopco Inc. d/b/a Unilever PYRITHIONE ZINC .5 mL/100mL 64942-1052_798e1ec0-8e6e-4704-9581-c4d64e72eca1 64942-1052 HUMAN OTC DRUG Dove Ultimate Go Fresh Refreshing Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM 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HUMAN OTC DRUG Degree For Women Delicious Bliss Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-1065_7e6e7da4-e59f-4b1a-a914-640ce3e069d3 64942-1065 HUMAN OTC DRUG Degree For Women Sexy Intrique Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-1066_065866b2-a703-49ad-a3f9-9df86e296550 64942-1066 HUMAN OTC DRUG Degree For Women Classic Romance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-1069_851d20c4-2207-4401-8c7a-6093c1dce221 64942-1069 HUMAN OTC DRUG Dove Ultimate Beauty Care Silk Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1071_9f8a1cce-1030-4a41-a155-0b310a69a779 64942-1071 HUMAN OTC DRUG Dove Ultimate Beauty Care Original Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1073_f27b7de7-9796-4392-86f0-ac5f9d609e05 64942-1073 HUMAN OTC DRUG Dove Clinical Protection Cool Energizing Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110907 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1074_c06aea0a-e4cf-4a57-8a4a-4827b20c2a9d 64942-1074 HUMAN OTC DRUG Dove Clinical Protection Visibly Smooth Wild Rose Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1077_5d612890-30cb-41b2-80ad-bbab7fa940ad 64942-1077 HUMAN OTC DRUG Suave Men Sport Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090402 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-1086_6da6efa7-9246-4140-9364-e9d4f18a1b2e 64942-1086 HUMAN OTC DRUG Axe Dark Temptation Invisible Solid Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-1087_885f4e11-2480-4a89-8ee2-fc8cfcb357d1 64942-1087 HUMAN OTC DRUG Dove Ultimate Beauty Care Smooth Cashmere Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1088_7e1e5c0d-883e-4bd6-b121-8de033177ada 64942-1088 HUMAN OTC DRUG Dove Ultimate Visibly Smooth Nature Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100118 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1089_eeb8dfff-6049-410c-90b1-ef3886cf174d 64942-1089 HUMAN OTC DRUG Degree Girl Just Dance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-1090_b2b1d1fa-2ab2-4763-94cb-eb095c619274 64942-1090 HUMAN OTC DRUG Dove Ultimate Sensitive Care Fragrance Free Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1093_b6d6a71d-452c-46b5-84ce-469502bb0343 64942-1093 HUMAN OTC DRUG Degree for Men Absolute Protection V12 Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.5 g/100g 64942-1096_0e8f7864-1d6c-4ce5-83d5-a38545c94ea6 64942-1096 HUMAN OTC DRUG Degree for Men Cool Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-1099_5c863b84-c518-4759-9dfe-40e007babd03 64942-1099 HUMAN OTC DRUG Axe Feeze AntiDandruff Shampoo plus Conditioner SHAMPOO TOPICAL 20090802 OTC MONOGRAPH FINAL part358 Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL 64942-1100_a5e0d1b9-7ae9-4664-be9c-3482804ec496 64942-1100 HUMAN OTC DRUG Axe Twist Invisible Solid Antiperspirant and Deodorant STICK TOPICAL OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-1101_c26632da-38f0-4d52-a323-a07adc444c10 64942-1101 HUMAN OTC DRUG Axe Phoenix Invisible Solid Antiperspirant and Deodorant STICK TOPICAL OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-1102_bf1946ee-e2c5-451b-8913-04b4e5b3a52c 64942-1102 HUMAN OTC DRUG Dove Ultimate Beauty Care Light Radiance Antiperspirant and Deodorant STICK TOPICAL 20091201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1103_a75c63c6-7b44-4ccf-8e86-b1cc70d437ee 64942-1103 HUMAN OTC DRUG Degree Women Nature Effects Honeysuckle and Tea Tree Oil Antiperspirant and Deodorant STICK TOPICAL 20090901 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-1104_d3d16b36-e471-49b7-ac5d-359e6f40b9aa 64942-1104 HUMAN OTC DRUG Degree Women Nature Effects Olive Leaf and Pink Pepper Antiperspirant and Deodorant STICK TOPICAL 20090901 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-1105_fd4bfb4e-e49f-4da6-a9c6-99381cd73f17 64942-1105 HUMAN OTC DRUG Degree Men Sport Defense Invisible Stick Antiperspirant and Deodorant STICK TOPICAL 20090901 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.5 g/100g 64942-1106_30c84bde-ffba-4d84-a61e-e96129477af7 64942-1106 HUMAN OTC DRUG Dove Ultimate Go Fresh Revive Antiperspirant and Deodorant STICK TOPICAL 20091201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1107_18f857bb-b8b6-4384-8208-9667d630f885 64942-1107 HUMAN OTC DRUG Suave Wild Cherry Blossom Antiperspirant and Deodorant STICK TOPICAL 20090905 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g 64942-1108_a8e5146e-006e-4167-aa48-447771ec06c3 64942-1108 HUMAN OTC DRUG Dove Ultimate Beauty Care Sheer Silk Antiperspirant and Deodorant STICK TOPICAL 20090905 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1110_a326b44f-a797-46ce-a7d4-1e38011a5ea0 64942-1110 HUMAN OTC DRUG Degree Ultraclear Red Satin AP and Deo STICK TOPICAL 20091215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1111_82ce1b23-74ff-4bd8-8da0-7fd5d1566212 64942-1111 HUMAN OTC DRUG Degree Women Clinical Protection Sexy Intrigue Invisible Stick Antiperspirant and Deodorant STICK TOPICAL 20091215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1112_8f8e2d87-f184-44bb-8213-9507aac85c0e 64942-1112 HUMAN OTC DRUG Degree Men Clinical Protection Adventure Invisible Stick Antiperspirant and Deodorant STICK TOPICAL 20091006 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1113_2cfec917-ec03-45ad-b175-6835bb2faa55 64942-1113 HUMAN OTC DRUG Suave Fresh Aerosol Antiperspirant and Deodorant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 8.8 g/100g 64942-1114_4dada618-49c7-48bf-8357-415726ae8a51 64942-1114 HUMAN OTC DRUG Suave Powder Aerosol Antiperspirant and Deodorant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 8.8 g/100g 64942-1115_98692e5f-dbd1-4672-ad96-9f3d3ac714db 64942-1115 HUMAN OTC DRUG Degree Girl Friends Forever Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100106 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 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HUMAN OTC DRUG Degree Nature Effects Orange Flower and Cranberry Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100106 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-1120_5591784e-a4ad-4f6a-bd53-8cdd5ffa9881 64942-1120 HUMAN OTC DRUG Dove Ultimate Visibly Smooth Wild Rose Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090414 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1122_29792d40-ae4c-4761-9d64-5f29c3508628 64942-1122 HUMAN OTC DRUG Suave Cocoa Butter Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101010 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1123_ba458cd3-3a9a-42ae-bef6-079545c39f95 64942-1123 HUMAN OTC DRUG Dove Men plus Care Clean Comfort Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101006 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1124_cfd8df70-e9c7-46da-abf1-acbda8663ca4 64942-1124 HUMAN OTC DRUG Dove Men plus Care Unscented Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1125_9a962caa-c793-4ff3-9233-1d10f7697f4f 64942-1125 HUMAN OTC DRUG Degree Men Adventure Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100909 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.5 g/100g 64942-1126_0082c034-35ae-4421-a56f-ef2b27dfbec0 64942-1126 HUMAN OTC DRUG Dove Ultimate Go Fresh Rebalance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1127_da39500e-2d35-4cf8-a83c-37e732c184d8 64942-1127 HUMAN OTC DRUG Dove Pearl Finish Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1128_e753c6f8-93a0-4c43-a073-72b1d56c5466 64942-1128 HUMAN OTC DRUG Dove Nourished Beauty Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 64942-1129_dd20d352-30a4-4a46-81ed-f07e9d769ef3 64942-1129 HUMAN OTC DRUG Dove Men plus Care Extra Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g 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20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-1154_5229d6fc-a9e0-494b-86a4-7c9d4e3200eb 64942-1154 HUMAN OTC DRUG Degree Adrenaline Sport Defense Invisible Stick Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101222 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.5 g/100g 64942-1155_26181efd-c76e-4275-b98b-7b51250a504e 64942-1155 HUMAN OTC DRUG Degree Girl Love Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g 64942-1156_c901efc4-c13a-4ce5-99f3-9307180adf16 64942-1156 HUMAN OTC DRUG Degree Girl Just Dance Invisible Solid Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110209 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever 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64942-1164_dc8a40eb-c1b9-43f7-8fa3-77e7e4bc777a 64942-1164 HUMAN OTC DRUG Axe Dry Phoenix Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1165_4d5a694e-d925-4f5f-af94-f19e22b1bf4f 64942-1165 HUMAN OTC DRUG Axe Dry Dark Temptation Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1166_9262d7e8-317a-48c1-8fce-592509623d27 64942-1166 HUMAN OTC DRUG Axe Dry Twist Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1167_16caeebe-08b1-49e1-b87d-eabc7cf7a9c5 64942-1167 HUMAN OTC DRUG Axe Dry Excite Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1168_666abf36-4357-455c-93a0-650503606a13 64942-1168 HUMAN OTC DRUG Axe Dry Sharp Focus Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1169_189f99b0-536a-4d80-b8e1-7f942b258e29 64942-1169 HUMAN OTC DRUG Axe Dry Essence Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1170_12a67b18-aaee-4fc7-bbbc-6ee6d327f593 64942-1170 HUMAN OTC DRUG Axe Dry Kilo Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1171_628ddab0-8011-4ab0-bdab-b7f20fc1c42a 64942-1171 HUMAN OTC DRUG Axe Dry Clix Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1172_e8c68e83-62c6-494a-bf40-0af2ff806143 64942-1172 HUMAN OTC DRUG Degree Red Satin Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1173_0d54b1c4-b3f0-406f-a9cd-6c9013e87d75 64942-1173 HUMAN OTC DRUG Degree Pure Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1174_ce1651e1-8230-42e7-9c6d-833313288305 64942-1174 HUMAN OTC DRUG Degree Pure Rain Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1175_4d2b4f99-47c5-465a-885c-dad4be47d2c1 64942-1175 HUMAN OTC DRUG Degree Classic Romance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1176_e0a3ae8a-5c91-43fd-86e9-38975dca9b29 64942-1176 HUMAN OTC DRUG Degree Sexy Intrigue Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1177_f57746e7-b4f0-480b-91d4-1f6cb5c23080 64942-1177 HUMAN OTC DRUG Degree Orange Flower and Cranberry Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1178_8620b565-bc74-4683-90d6-fec82979d519 64942-1178 HUMAN OTC DRUG Degree Honeysuckle and Tea Tree Oil Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1179_0b3e3df6-081e-42a5-9465-f7ed7bd46e1a 64942-1179 HUMAN OTC DRUG Degree Cool Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1180_53758b3e-d246-40b0-b7bf-83240b99423a 64942-1180 HUMAN OTC DRUG Degree Sport Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1181_2b5bd4df-bc84-4708-9878-769a0e80703b 64942-1181 HUMAN OTC DRUG Degree Extreme Blast Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1182_1f1800ce-e8d6-4e61-a334-2968308b9a89 64942-1182 HUMAN OTC DRUG Degree Power Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1183_16eac702-9645-40c7-93de-a278eef867a9 64942-1183 HUMAN OTC DRUG Degree Cool Comfort Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1184_6b8595a0-c194-420a-af87-8282f4a9f384 64942-1184 HUMAN OTC DRUG Degree Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1185_8eaeaeac-b058-428b-abb6-4ad1f01ed950 64942-1185 HUMAN OTC DRUG Axe Freeze AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20090802 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL 64942-1186_a3aa1f6b-c21d-478b-93c1-f4df94b02c0f 64942-1186 HUMAN OTC DRUG Axe Armor AntiDandruff 2 in 1 Pyrithione Zinc SHAMPOO TOPICAL 20081223 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL 64942-1187_7a6eafc0-2d69-4780-8dc6-95adc56909a1 64942-1187 HUMAN OTC DRUG Degree Men Clinical Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110623 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1188_ddd7941c-02fa-4322-af12-0529eadd0638 64942-1188 HUMAN OTC DRUG Degree Men Clinical Cool Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110623 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1189_50d96f77-3175-4d2c-93a7-e5c32fab5660 64942-1189 HUMAN OTC DRUG Degree Clinical Adventure Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110623 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1190_d34e43e6-8cf8-44dc-a4fe-04cc709dcbaa 64942-1190 HUMAN OTC DRUG Vaseline Total Moisture Aloe Fresh SPF 15 OCTISALATE, AVOBENZONE, ENSULIZOLE LOTION TOPICAL 20120801 OTC MONOGRAPH FINAL part352 CONOPCO Inc. d/b/a Unilever AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE 20; 15; 50; 13 mg/mL; mg/mL; mg/mL; mg/mL 64942-1191_23363104-38f5-4097-8891-dc6e00c703d0 64942-1191 HUMAN OTC DRUG Degree Shower Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110810 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1192_63ccf1a6-cf8f-403d-98ef-4c07505d22fe 64942-1192 HUMAN OTC DRUG Degree Sheer Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110810 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1193_a1d9b9d3-9327-457f-b35f-33d4189f3110 64942-1193 HUMAN OTC DRUG Degree Love Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110810 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1194_4c380459-df30-4038-8762-36878db8e90e 64942-1194 HUMAN OTC DRUG Degree V12 Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 64942-1195_913d2c56-ebcb-4acd-b456-012e71e43643 64942-1195 HUMAN OTC DRUG Suave Cocoa Butter Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20111005 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g 64942-1196_9fd80ca3-4af0-494c-82f5-9b051e4c3c33 64942-1196 HUMAN OTC DRUG Axe Dry Anarchy Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1197_4ae15e0f-9980-43b4-a5fd-70708661ff8a 64942-1197 HUMAN OTC DRUG Degree Sport Defense Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 64942-1198_cbac03b4-8eb3-40b5-8445-6449c02febcd 64942-1198 HUMAN OTC DRUG Degree Adventure Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 64942-1199_49955602-9dbc-4ab5-bf23-17e0dd198038 64942-1199 HUMAN OTC DRUG Degree Extreme Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 64942-1200_511ef2eb-08bb-48b4-996d-7e6f48063724 64942-1200 HUMAN OTC DRUG Degree Clinical Protection Motion Sense Cotton Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1201_d6ebf3ae-e379-4131-8901-7c939cd4a87f 64942-1201 HUMAN OTC DRUG Degree Clinical Men Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110825 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1202_eeb2e3be-73c1-4659-81c7-efb075f51bbe 64942-1202 HUMAN OTC DRUG Degree Clinical Men Sport Strength Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110825 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1203_24d398c9-f60d-4954-9409-e00ad7c0d088 64942-1203 HUMAN OTC DRUG Degree Clinical Men Extreme Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110825 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1204_582f34dd-a29a-42fe-8a2b-55d85a6fa506 64942-1204 HUMAN OTC DRUG Dove Clinical Protection Cleartone Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110826 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1205_8168adf0-791a-4d1b-810b-d00e79209187 64942-1205 HUMAN OTC DRUG Suave Clinical Protection Everlasting Sunshine Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110826 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1206_719ec220-9e3d-4109-a92e-d2f1d7eb7868 64942-1206 HUMAN OTC DRUG Degree Cool Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 64942-1207_712711b6-7968-49fc-a9e9-29aab2552544 64942-1207 HUMAN OTC DRUG Degree Motion Sense Linen Dry Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1208_80897e7f-9671-4cfc-b72c-79740058a968 64942-1208 HUMAN OTC DRUG Degree Clinical Protection Motion Sense Linen Dry Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1209_cf299595-b298-49d0-9608-a8913cc72451 64942-1209 HUMAN OTC DRUG Degree Nature Effects Absorbent Sea Salt Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1210_13614a58-4788-41f4-a8c0-7e4881ef8460 64942-1210 HUMAN OTC DRUG Dove Cleartone Skin Renew Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1211_6f2a7011-fdbb-46a5-a128-9d7ee8314cdb 64942-1211 HUMAN OTC DRUG Dove Men plus Care Aqua Impact Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1212_70c289e8-c590-4673-bc7e-a37771851f2f 64942-1212 HUMAN OTC DRUG Dove Go Fresh Rebalance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1213_5db8396d-45d0-4172-88d0-5ba6c321ab5d 64942-1213 HUMAN OTC DRUG Dove Go Sleeveless Nourished Beauty Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1214_4a7c7b27-b503-4870-80fe-97e44482e0af 64942-1214 HUMAN OTC DRUG Dove Revive Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1215_2911fe70-a59d-4e5c-90e6-ff19e2e11dba 64942-1215 HUMAN OTC DRUG Dove Cool Essentials Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1216_146f12d0-b567-4f58-b436-2deb1f1bcdcd 64942-1216 HUMAN OTC DRUG Dove Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1217_4f03ac89-b572-41bd-be45-e6c97cbd6c90 64942-1217 HUMAN OTC DRUG Dove Go Sleeveless Fragrance Free Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111110 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1218_19f1fe39-0ffe-4314-868a-ac3c208a7281 64942-1218 HUMAN OTC DRUG Dove Clean Comfort Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111110 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1219_a96c533f-7485-4070-9896-7e998a5f3301 64942-1219 HUMAN OTC DRUG Dove Extra Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111110 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1220_e52ae062-eb2e-4064-a3ff-cb3551f8497d 64942-1220 HUMAN OTC DRUG Dove Radiant Silk Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111110 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1221_3a355d5c-7d48-49ae-95df-51a3af070fba 64942-1221 HUMAN OTC DRUG Dove Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111110 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1222_ec9edeb8-88d1-4aa9-9ca4-fae2bce464a2 64942-1222 HUMAN OTC DRUG Dove Clinical Protection Soothing Chamomile Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1223_9fcad333-7b2d-475c-ac05-a46da9e1b74a 64942-1223 HUMAN OTC DRUG Dove Cleartone Sheer Touch Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111230 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1224_2d3c05a3-f956-426a-8572-0dfc0c24e657 64942-1224 HUMAN OTC DRUG Dove Cleartone Pink Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120126 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1225_236408dd-6806-4ffc-91f5-d8e99249c3bb 64942-1225 HUMAN OTC DRUG Dove Go Sleeveless Soothing Chamomile Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1226_ea414494-3ae0-4538-b40a-23a43bf378c0 64942-1226 HUMAN OTC DRUG Dove Go Sleeveless Original Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111231 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1227_9d359512-9113-453c-a61c-fe26ad08a258 64942-1227 HUMAN OTC DRUG Dove Go Sleeveless Beauty Finish Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1228_234a790d-2437-46ef-aa37-ac159e894f56 64942-1228 HUMAN OTC DRUG Dove Go Fresh Burst Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1229_a972c581-f565-4485-885b-c5a1f7203c9a 64942-1229 HUMAN OTC DRUG Dove Go Fresh Energizing Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1230_9a4dc425-9959-4c6d-997c-dd899d69e051 64942-1230 HUMAN OTC DRUG Dove Sensitive Skin Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120214 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1231_4988b7d6-6b29-4a85-937c-199333107848 64942-1231 HUMAN OTC DRUG Suave Everlasting Sunshine Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20111005 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g 64942-1232_8835527b-57c4-4703-9430-077ff2c9cf73 64942-1232 HUMAN OTC DRUG Degree Invisible Solid Fresh Oxygen Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110810 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1233_087b9d19-85cc-4e66-bc4b-06b9e2a1f499 64942-1233 HUMAN OTC DRUG Suave Revitalizing Mint and Eucalyptus AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120101 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL 64942-1234_5a3882c5-369a-424c-a09a-345206e8dfb5 64942-1234 HUMAN OTC DRUG Suave Invigorating Ocean Minerals and Aloe Vera AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120101 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL 64942-1235_f3807af3-7d4f-4344-ae98-da28bd536e74 64942-1235 HUMAN OTC DRUG Suave Nourishing Coconut and Shea Butter AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120101 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL 64942-1236_e2ad7a1f-c890-4f36-9b02-febc382d0ba1 64942-1236 HUMAN OTC DRUG Suave Revitalizing Mint and Eucalyptus AntiDandruff Conditioner Pyrithione Zinc SUSPENSION TOPICAL 20120209 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC .5 mL/100mL 64942-1237_cb29bb35-0161-403e-9d26-d3e9477d8099 64942-1237 HUMAN OTC DRUG Suave Nourishing Coconut and Shea Butter AntiDandruff Conditioner Pyrithione Zinc SUSPENSION TOPICAL 20120209 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC .5 mL/100mL 64942-1238_e1d46e68-b110-454b-ae59-14e10b1e78fd 64942-1238 HUMAN OTC DRUG Clear Men 2 in 1 Complete Care AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120509 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL 64942-1240_3a6c129c-9543-4302-8289-6f7970b80928 64942-1240 HUMAN OTC DRUG Degree Girl Twilight Kiss Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1241_74187120-1214-4f77-bc26-28975a0950ca 64942-1241 HUMAN OTC DRUG Dove Original Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120214 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1242_fb5d9afc-866a-488b-b96f-d9f781358b9d 64942-1242 HUMAN OTC DRUG Dove Nature Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1243_87577d4a-67c8-4420-9601-9be47870a503 64942-1243 HUMAN OTC DRUG Dove Wild Rose Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1244_780a1859-e587-42bf-bb9e-201b605c5286 64942-1244 HUMAN OTC DRUG Simple Vital Vitamin Day Cream SPF 15 Homosalate, Octisalate, Avobenzone, and Octocrylene EMULSION TOPICAL 20120301 OTC MONOGRAPH FINAL part352 CONOPCO Inc. d/b/a Unilever AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .03; .12; .05; .027 g/g; g/g; g/g; g/g 64942-1245_5bccc639-0fc5-48e7-b3b3-9e1ed536e878 64942-1245 HUMAN OTC DRUG St. Ives Blemish and Blackhead Control Apricot Scrub Salicylic Acid EMULSION TOPICAL 20120301 OTC MONOGRAPH FINAL part333D CONOPCO Inc. d/b/a Unilever SALICYLIC ACID .02 g/g 64942-1246_3cb130db-17b8-4711-b8d5-5d79722e9b55 64942-1246 HUMAN OTC DRUG St. Ives Green Tea Cleanser Salicylic Acid EMULSION TOPICAL 20120308 OTC MONOGRAPH FINAL part333D CONOPCO Inc. d/b/a Unilever SALICYLIC ACID .02 mL/mL 64942-1247_e531aebc-1cfa-47b5-9495-07b7ad6ad9da 64942-1247 HUMAN OTC DRUG St. Ives Green Tea Scrub Salicylic Acid EMULSION TOPICAL 20120308 OTC MONOGRAPH FINAL part333D CONOPCO Inc. d/b/a Unilever SALICYLIC ACID .01 mL/mL 64942-1248_87686883-277b-4e5a-a011-70c95808158e 64942-1248 HUMAN OTC DRUG Clear Men 2 in 1 Dry Scalp Hydration AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120509 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL 64942-1249_51e1da3e-ac27-4431-b579-7251b0801515 64942-1249 HUMAN OTC DRUG Clear Men Strong and Full AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120509 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL 64942-1250_36f8d93d-53bf-4c91-8aba-4a35ac4fcc6f 64942-1250 HUMAN OTC DRUG Clear Men 2 in 1 Clean and Refresh AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120509 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL 64942-1252_4a07fc4a-738c-450e-9608-348c24964128 64942-1252 HUMAN OTC DRUG Clear Complete Care AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120509 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL 64942-1253_b0a5ad97-922e-41c8-966b-a4f099c2947c 64942-1253 HUMAN OTC DRUG Dove Powder Roll On Antiperspirant and Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20120712 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 22 mg/100mL 64942-1256_d53ad77c-a2cf-4acd-98d2-7cf362bbc5db 64942-1256 HUMAN OTC DRUG Dove Men plus Care Hydrate Face SPF 15 AVOBENZONE, ENSULIZOLE, OCTICSALATE LOTION TOPICAL 20120801 OTC MONOGRAPH FINAL part352 CONOPCO Inc. d/b/a Unilever AVOBENZONE; ENSULIZOLE; OCTISALATE 3; 1; 5 g/100mL; g/100mL; g/100mL 64942-1257_2245cf2f-9e5f-4c6a-a8e7-137853215932 64942-1257 HUMAN OTC DRUG Degree Clinical Men Thermo Dry Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1258_8419fef1-acf2-4c2d-be3e-b71dbecbe258 64942-1258 HUMAN OTC DRUG Degree Clinical Protection Motion Sense Summer Strength Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1259_d96bef2e-2a7d-4d0f-aee7-4441c2d2bd5f 64942-1259 HUMAN OTC DRUG Noxzema ANTIBLEMISH Salicylic Acid CLOTH TOPICAL 20120901 OTC MONOGRAPH FINAL part333D Conopco Inc. SALICYLIC ACID .02 g/g 64942-1260_0608f751-d060-4d8a-839b-d382bac36661 64942-1260 HUMAN OTC DRUG Dove Go Fresh Restore Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120910 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1261_298b64b8-2e7e-44d0-9509-e5ab543ff07e 64942-1261 HUMAN OTC DRUG Degree Ironman Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120920 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 64942-1262_91eeab16-c1dc-4e9c-a0b5-9982936c9688 64942-1262 HUMAN OTC DRUG Axe Dry Apollo Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120920 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1263_41e5e3ee-1943-4deb-be59-94ff706c3ad8 64942-1263 HUMAN OTC DRUG Degree Motion Sense Sheer Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120920 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1264_e08c4b3f-82cb-45c1-8502-3c9b9ba11980 64942-1264 HUMAN OTC DRUG Noxzema Bacteria Fighting Cleanser Triclosan SOAP TOPICAL 20121002 OTC MONOGRAPH NOT FINAL part333E CONOPCO Inc. d/b/a Unilever TRICLOSAN .003 g/g 64942-1265_a6223503-9fae-42c7-be5e-9d2dad0b0c03 64942-1265 HUMAN OTC DRUG Noxzema AntiBlemish Daily Scrub Salicyclic Acid SOAP TOPICAL 20121002 OTC MONOGRAPH FINAL part333D CONOPCO Inc. d/b/a Unilever SALICYLIC ACID .01 g/g 64942-1266_cde43908-f7a2-4a7d-a2d2-fc5dddc414e8 64942-1266 HUMAN OTC DRUG Degree Motion Sense Sexy Intrigue Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20121015 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1267_4b8b55b6-801d-404f-abda-8e92c92e4730 64942-1267 HUMAN OTC DRUG Dove Men plus Care Cool Silver Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20121015 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1268_11b69a75-a719-42dd-a91c-e0fd605338ce 64942-1268 HUMAN OTC DRUG Suave Ocean Breeze Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20121012 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g 64942-1269_22c6a14c-385b-4785-93a0-0b9145f3d118 64942-1269 HUMAN OTC DRUG Clear Men 2 in 1 Complete Care AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120509 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL 64942-1270_67fcfdc3-4d74-4c72-a93f-103fdb472947 64942-1270 HUMAN OTC DRUG Degree Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1272_a5841714-3aaa-4490-9ac3-d8fc5b02704b 64942-1272 HUMAN OTC DRUG Axe Dry Black Chill Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20121230 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1273_90b40983-0998-442b-a838-bd85cffed265 64942-1273 HUMAN OTC DRUG DOVE MEN PLUS CARE ANTI DANDRUFF Pyrithione Zinc SHAMPOO TOPICAL 20130101 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL 64942-1274_ee75de76-8e19-46a6-8b44-3c1e0457d1cd 64942-1274 HUMAN OTC DRUG Dove Clear Solid Beauty Finish Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130228 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1275_f4c40e1b-e53d-4362-87af-810c13c289e5 64942-1275 HUMAN OTC DRUG Dove Clear Solid Soothing Chamomile Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130228 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1276_a67164b2-6adc-447d-80f6-89f263419093 64942-1276 HUMAN OTC DRUG Dove Visibly Clear Cool Essentials Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130228 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1277_8040199b-cc42-4801-90b9-84e3bca32f50 64942-1277 HUMAN OTC DRUG Dove Clear Solid Revive Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130228 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1278_326dfe1a-2df1-48b8-8986-654e584ce7dc 64942-1278 HUMAN OTC DRUG Dove Clear Solid Rebalance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130228 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1279_90beaf64-9322-4a18-9f01-d6e7058ece77 64942-1279 HUMAN OTC DRUG Degree Clear Solid Silky Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1280_d418e6f7-5008-4c4b-935c-ba7345f76d7c 64942-1280 HUMAN OTC DRUG Degree Clear Solid Floral Breeze Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130228 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1281_415b32c8-f1de-4980-9471-f11bb58773ac 64942-1281 HUMAN OTC DRUG Degree Clear Solid Shower Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130228 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1282_21fa9495-35c7-44f4-aa4f-a5492d973c08 64942-1282 HUMAN OTC DRUG Degree Clear Solid Sheer Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1283_f91c33b0-b373-4863-a46b-8fb8a85deb67 64942-1283 HUMAN OTC DRUG Degree Clear Solid Lightly Scented Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1284_b5f08ecf-a372-4972-9e3f-db378e1bdc98 64942-1284 HUMAN OTC DRUG Ponds Luminous Finish BB cream Medium SPF 15 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20130617 OTC MONOGRAPH FINAL part352 CONOPCO Inc. d/b/a Unilever OCTINOXATE; ZINC OXIDE 7.49; 5.12 g/100mL; g/100mL 64942-1285_9bd8e2af-4f09-43a1-b5c4-d190a9312362 64942-1285 HUMAN OTC DRUG Ponds Luminous Finish BB cream Light SPF 15 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20130617 OTC MONOGRAPH FINAL part352 CONOPCO Inc. d/b/a Unilever OCTINOXATE; ZINC OXIDE 7.49; 5.12 g/100mL; g/100mL 64942-1286_54dcbd65-b03e-4360-a0ab-645a5f912c15 64942-1286 HUMAN OTC DRUG Clear Men Cool Sport Mint AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120509 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL 64942-1287_5724c2ef-4b84-4de9-b238-6bb8663b49a9 64942-1287 HUMAN OTC DRUG Clear Men Clean and Refresh AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120509 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL 64942-1288_57ba6673-411d-44c3-bb65-ac640e5aab54 64942-1288 HUMAN OTC DRUG Ponds Luminous Moisture Day SPF 15 AVOBENZONE, ENSULIZOLE, OCTICSALATE LOTION TOPICAL 20120801 OTC MONOGRAPH FINAL part352 CONOPCO Inc. d/b/a Unilever AVOBENZONE; ENSULIZOLE; OCTISALATE 3; 1; 5 g/100mL; g/100mL; g/100mL 64942-1289_b51281c8-d5e5-43e5-9846-f9d6f28b46e3 64942-1289 HUMAN OTC DRUG Axe AntiDandruff Styling Pyrithione Zinc CREAM TOPICAL 20130219 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC .2 g/100g 64942-1290_0213299f-168d-4412-820f-965cbd46ce9d 64942-1290 HUMAN OTC DRUG Simple Protecting Light Moisturizer SPF 15 AVOBENZONE, ENSULIZOLE, OCTICSALATE LOTION TOPICAL 20130701 OTC MONOGRAPH FINAL part352 CONOPCO Inc. d/b/a Unilever AVOBENZONE; ENSULIZOLE; OCTISALATE 3; 1; 5 g/100mL; g/100mL; g/100mL 64942-1292_da4b1de7-bd80-411a-9fe1-4a2e983b8d86 64942-1292 HUMAN OTC DRUG Suave Powder Antiperspirant and Deodorant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20130301 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 8.8 g/100g 64942-1293_f0b7568c-9a7f-4089-959e-b1a9c3a28590 64942-1293 HUMAN OTC DRUG Suave Fresh Antiperspirant Deodorant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20130301 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 8.8 g/100g 64942-1294_5828cca5-24c5-47bb-ba6f-70c70fd4d81c 64942-1294 HUMAN OTC DRUG Degree Shower Clean Antiperspirant Deodorant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20130409 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 8.8 g/100g 64942-1295_0cf51f38-5fdf-4eba-bd39-b20a13df3b19 64942-1295 HUMAN OTC DRUG Degree Sport Antiperspirant and Deodorant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20130409 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 8.8 g/100g 64942-1296_b8981683-5d96-4b19-be4a-320b0e4d4354 64942-1296 HUMAN OTC DRUG St. Ives Blemish Control Green Tea Scrub Salicylic Acid EMULSION TOPICAL 20130615 OTC MONOGRAPH FINAL part333D CONOPCO Inc. d/b/a Unilever SALICYLIC ACID .01 g/mL 64942-1297_f26b3035-6587-4a03-854a-841194c184e4 64942-1297 HUMAN OTC DRUG St. Ives Green Tea Cleanser Salicylic Acid EMULSION TOPICAL 20130615 OTC MONOGRAPH FINAL part333D CONOPCO Inc. d/b/a Unilever SALICYLIC ACID .02 g/mL 64942-1298_44f83d25-8668-446d-a512-8a874f860563 64942-1298 HUMAN OTC DRUG Degree Expert Protection Motion Sense Daisy Fresh Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130630 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1299_87be10e9-0400-48a7-a297-464a10a0191d 64942-1299 HUMAN OTC DRUG Degree Expert Protection Motion Sense Peach Burst Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130630 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1300_37bc5a36-0fa2-4720-9ee2-da3514deac6f 64942-1300 HUMAN OTC DRUG Dove Go Sleeveless Shea Butter Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130630 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1301_120210ba-2573-40aa-aded-d85502e69efa 64942-1301 HUMAN OTC DRUG Degree Clinical Protection Motion Sense Stress Control Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130920 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1302_da9d0511-98fd-4d2e-af00-c3f922f24207 64942-1302 HUMAN OTC DRUG Axe 2 in 1 Armor AntiDandruff 2 in 1 Pyrithione Zinc SHAMPOO TOPICAL 20130610 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL 64942-1303_139f7e29-f3ba-4790-ac92-e4e40597e3f8 64942-1303 HUMAN OTC DRUG Degree Clinical Sheer Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131111 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1304_c93ad605-b0c0-4b68-afdd-b32aacf5a6c2 64942-1304 HUMAN OTC DRUG Degree Clinical Shower Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131111 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1305_580ae164-7a60-4d8c-993b-7bf0b27a4be7 64942-1305 HUMAN OTC DRUG Dove DermaSeries Rough Patch Treatment Dimethicone LOTION TOPICAL 20131010 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever DIMETHICONE 1.1 g/100mL 64942-1306_f43693e6-cb47-4f44-a2af-ece97e5ff046 64942-1306 HUMAN OTC DRUG Dove DermaSeries Eczema Therapy Cream Oatmeal CREAM TOPICAL 20131015 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever OATMEAL 1 g/100mL 64942-1307_81ca3d31-966b-41e1-8db5-7e139f8ad15f 64942-1307 HUMAN OTC DRUG Dove DermaSeries Intense Repairing Body Cream Dimethicone CREAM TOPICAL 20131015 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever DIMETHICONE 6 g/100mL 64942-1308_8d6d0c09-aedd-4d40-9e0d-5a1ef12ea5f8 64942-1308 HUMAN OTC DRUG Suave Ocean Breeze Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g 64942-1309_93ad0552-1f3a-42c4-987a-6d374ce2058b 64942-1309 HUMAN OTC DRUG Clear 2 in 1 Scalp Comfort AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL 64942-1310_358e5ea2-780e-4dc1-9450-8e2958d96765 64942-1310 HUMAN OTC DRUG Clear Men 2 in 1 Dry Scalp Hydration AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120509 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL 64942-1311_fc1c23b4-778f-4fec-819a-c3769e535d50 64942-1311 HUMAN OTC DRUG Clear Men Deep Clean Hydration AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20131201 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL 64942-1312_99844fef-8f97-469d-a490-4e5a12fe0346 64942-1312 HUMAN OTC DRUG Clear Men Ocean Mineral AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20131201 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL 64942-1313_1c4d8f5f-0c28-4c41-a824-39be04accd69 64942-1313 HUMAN OTC DRUG Clear Men Citrus Fresh Hydration AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20131201 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL 64942-1314_09067fc3-e062-4caf-978d-ffd7c4236e3c 64942-1314 HUMAN OTC DRUG Axe Dry Peace Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131130 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1315_a9531aa6-c818-4242-83be-28fe7ac9b561 64942-1315 HUMAN OTC DRUG Axe Dry Harmony Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131130 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1316_1c83a155-e9c7-4b04-aaec-e400eccea178 64942-1316 HUMAN OTC DRUG Suave Clinical Protection Almond Verbena Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131001 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1317_692021e5-4265-4f3f-8741-76d1a6413864 64942-1317 HUMAN OTC DRUG Degree Overtime Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1318_14dd20a2-ddb2-43c7-8a99-b7f7f7529889 64942-1318 HUMAN OTC DRUG Degree Cool Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1319_4f4590f6-4d3f-47df-8eb8-493b5cd09434 64942-1319 HUMAN OTC DRUG Suave Almond Verbena Antiperspirant Deodorant Aluminum Chlorohydrate STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g 64942-1320_a6743400-2f13-404d-869e-b97cd0b0f6db 64942-1320 HUMAN OTC DRUG Degree Adrenaline Everest Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131202 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1321_0b16b811-b3f4-484b-b2ba-04b977f7d03f 64942-1321 HUMAN OTC DRUG Degree Adrenaline Ironman Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131202 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1322_5e6b27bd-5534-4a64-adb0-8c5dce944ff5 64942-1322 HUMAN OTC DRUG Degree Adrenaline Adventure Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131202 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1323_ce9657ac-3ab4-42bc-a7a7-4d105b134523 64942-1323 HUMAN OTC DRUG Degree Adrenaline Extreme Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131202 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1324_51fc5b19-a573-43f4-bdb7-ff862b33e0a3 64942-1324 HUMAN OTC DRUG Degree Motion Sense Peach Burst Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1325_172bfe39-101e-43ad-b668-95d71d9944af 64942-1325 HUMAN OTC DRUG Degree Sheer Lilac Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1326_1bbe36c8-cdda-46d2-9d8d-1436cbd6822c 64942-1326 HUMAN OTC DRUG Degree Motion Sense Berry Cool Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1327_bc826efa-82b3-4ee6-b5a7-94c0f694ffb2 64942-1327 HUMAN OTC DRUG Degree Motion Sense Tropical Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1328_a11da22e-7c63-4eaf-837e-dee7dfa75c31 64942-1328 HUMAN OTC DRUG Degree Motion Sense Daisy Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1329_c3204ef5-75d9-433b-b1ee-5b92331b41c9 64942-1329 HUMAN OTC DRUG Degree Motion Sense Shower Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1330_ee69ed8a-f7ba-4022-b953-1cef67700072 64942-1330 HUMAN OTC DRUG Degree Motion Sense Sheer Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1331_af84c5a7-e40c-4e89-8a20-d7e2e7037251 64942-1331 HUMAN OTC DRUG Degree Motion Sense Sexy Intrigue Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1332_fb54b7c7-e03c-40e3-913e-2c0da382a626 64942-1332 HUMAN OTC DRUG Degree Motion Sense Fresh Energy Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1333_612360fe-e508-4989-8ffd-92972701d276 64942-1333 HUMAN OTC DRUG Dove Men plus Care Sensitive Face AVOBENZONE, ENSULIZOLE, OCTICSALATE, OCTOCRYLENE LOTION TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 CONOPCO Inc. d/b/a Unilever AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE 2; 1.5; 5; 1.3 g/100mL; g/100mL; g/100mL; g/100mL 64942-1334_480c7bb1-b987-47b1-8fe3-fdd0c4d73695 64942-1334 HUMAN OTC DRUG Dove Men plus Care Hydrate Face AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140123 OTC MONOGRAPH NOT FINAL part352 CONOPCO Inc. d/b/a Unilever AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE 2; 1.5; 5; 1.3 g/100mL; g/100mL; g/100mL; g/100mL 64942-1335_bc237a1a-73df-4022-9bee-dbb160e7e9f2 64942-1335 HUMAN OTC DRUG Degree Adrenaline Sport Defense Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131202 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1336_f6341f4c-618c-4f83-9a2b-b299f187c973 64942-1336 HUMAN OTC DRUG St. Ives Blackhead Clearing Green Tea Scrub Salicylic Acid EMULSION TOPICAL 20140101 OTC MONOGRAPH FINAL part333D CONOPCO Inc. d/b/a Unilever SALICYLIC ACID .01 g/mL 64942-1337_87479acf-a0cc-4372-8959-24e54a8d34a9 64942-1337 HUMAN OTC DRUG Dove Men plus Care Clean Comfort Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1338_131dbc6f-3965-4fdf-92a5-81dc03a280a0 64942-1338 HUMAN OTC DRUG Dove Men plus Care Extra Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1339_6556082f-af59-4b5c-bb2a-6fd2a69164a5 64942-1339 HUMAN OTC DRUG Dove Men plus Care Aqua Impact Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1340_7a7a0ab4-98ef-45e7-82a1-09c5db903a07 64942-1340 HUMAN OTC DRUG Dove Men plus Care Fresh Awake Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1341_3445fb35-dc78-4ffa-b9b7-be3a6f415f11 64942-1341 HUMAN OTC DRUG Dove Advanced Care Nourished Beauty Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1342_a5cc59a8-cfaf-4f88-9ddb-c787e2b7f0ca 64942-1342 HUMAN OTC DRUG Dove Advanced Care Beauty Finish Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1343_651a8852-97d2-4e8c-90d3-0389e81c09a4 64942-1343 HUMAN OTC DRUG Dove Advanced Care Cool Essentials Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1344_43bd3774-1092-474c-829e-aa25a990f0ec 64942-1344 HUMAN OTC DRUG Dove Advanced Care Rebalance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1345_e9f13c89-0180-4471-a379-81a4de00d151 64942-1345 HUMAN OTC DRUG Dove Advanced Care Revive Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1346_c7e410d2-4b32-4069-932f-c0a81d46c5d1 64942-1346 HUMAN OTC DRUG Dove Advanced Care Skin Renew Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1347_a8b79960-18a2-430c-88aa-63b0d406a1ff 64942-1347 HUMAN OTC DRUG Dove Advanced Care Sheer Touch Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1348_9fbfe2e6-5c9e-4a96-ab28-51e67f0d136e 64942-1348 HUMAN OTC DRUG Dove Advanced Care Pink Rosa Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1349_d2015778-e72a-43d2-9718-888277571bce 64942-1349 HUMAN OTC DRUG Dove Advanced Care Shea Butter Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1350_2358f182-f852-491a-8067-aa88cecbf4e3 64942-1350 HUMAN OTC DRUG Dove Advanced Care Sensitive Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1351_f8f2c464-7462-4e53-9043-e605be3f8145 64942-1351 HUMAN OTC DRUG Dove Advanced Care Caring Coconut Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1352_4a1a1c2d-dbf4-48b7-8ef0-2fffc761e984 64942-1352 HUMAN OTC DRUG Dove Go Sleeveless Sensitive Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1353_db851695-6b1c-4cb0-bfb6-dbfb14bfe804 64942-1353 HUMAN OTC DRUG Suave Professionals Men 2 in 1 Classic Clean AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20140122 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL 64942-1354_542cf41f-259a-422f-a8ba-54ab1467efe6 64942-1354 HUMAN OTC DRUG Axe Gold Temptation Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140326 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g 64942-1355_24ad4365-a9f3-4d4f-b410-228489f5e0ba 64942-1355 HUMAN OTC DRUG Simple Light Moisturizer SPF 15 AVOBENZONE, ENSULIZOLE, OCTICSALATE, OCTOCRYLENE LOTION TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 CONOPCO Inc. d/b/a Unilever AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE 2; 1.5; 5; 1.3 g/100mL; g/100mL; g/100mL; g/100mL 64942-1356_8aeece4c-7a03-4530-9535-cbc2d660b5c1 64942-1356 HUMAN OTC DRUG Clear Complete Care Nourishing AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20140413 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL 64942-1357_1a33afeb-9d19-409b-8f93-537c32bff8f6 64942-1357 HUMAN OTC DRUG Axe Freeze AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20090802 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL 64942-1358_034f0b9b-d952-4b26-a406-4d2ec47c0616 64942-1358 HUMAN OTC DRUG Dove Cool Essentials Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g 64942-1359_b074c8ac-fd7c-43d9-98a4-971851ba008c 64942-1359 HUMAN OTC DRUG Dove Beauty Finish Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g 64942-1360_8ef34e88-663e-495d-a253-3ec1d92990a8 64942-1360 HUMAN OTC DRUG Dove Sensitive Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g 64942-1361_b458389b-ec56-4e39-b6dd-1866fa69e266 64942-1361 HUMAN OTC DRUG Dove Clear Tone Skin Renew Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g 64942-1362_15de65d4-6e54-46b7-897a-22d5c18024ad 64942-1362 HUMAN OTC DRUG Dove Revive Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g 64942-1363_486ca33f-4cd3-4fe5-87e4-1c9065fe4b2a 64942-1363 HUMAN OTC DRUG Dove Nourished Beauty Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g 64942-1364_bae51d74-4e0c-4463-8c9e-23e481b4fbd5 64942-1364 HUMAN OTC DRUG Dove Men plus Care Extra Fresh Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g 64942-1365_f9cd44a8-50ee-48ad-844d-58e5bd0f7278 64942-1365 HUMAN OTC DRUG Dove Men plus Care Cool Silver Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g 64942-1366_0c755163-538f-495a-bb3b-0637fa0f5d82 64942-1366 HUMAN OTC DRUG Dove Men plus Care Clean Comfort Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g 64942-1367_a83ae336-f16a-4b96-b03c-b1e49bb191ee 64942-1367 HUMAN OTC DRUG Dove Men plus Care Unscented Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g 64942-1368_aa7f02d2-78d6-480f-a965-1bbe02cf7282 64942-1368 HUMAN OTC DRUG Axe Air Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 64942-1369_917ce24f-e1a7-48d3-83e1-91787c4085e5 64942-1369 HUMAN OTC DRUG Axe Night Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 64942-1371_7aa86723-c9ad-4f0d-b698-195b66e7ca48 64942-1371 HUMAN OTC DRUG Axe Island Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g 64942-1372_4714a090-92c8-4292-8071-bed846f03cda 64942-1372 HUMAN OTC DRUG Axe Air Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g 64942-1373_d5ea5f9c-8e66-497f-99b9-83b454fc592b 64942-1373 HUMAN OTC DRUG Axe Night Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g 64942-1374_797099fe-1fd1-406f-ae1b-e693355a79a6 64942-1374 HUMAN OTC DRUG Axe Forest Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g 64942-1375_dc6b6ce2-ef33-4b70-9214-ec0664b32ccb 64942-1375 HUMAN OTC DRUG Axe Island Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g 64942-1376_a13a670d-89c4-4bf2-ab87-2e07a68e9676 64942-1376 HUMAN OTC DRUG Degree Shower Clean Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g 64942-1377_7fa7e35f-0781-450d-94c7-0e021df05483 64942-1377 HUMAN OTC DRUG Degree Fresh Energy Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g 64942-1378_8790e66c-9709-4e10-8e97-8c80e19d0e0c 64942-1378 HUMAN OTC DRUG Degree Sheer Powder Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g 64942-1379_20e7eee4-8ba4-4b9d-ba92-32a423bc9a32 64942-1379 HUMAN OTC DRUG Degree Peach Burst Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g 64942-1380_48e138c5-e678-4610-8514-63b3095b641e 64942-1380 HUMAN OTC DRUG Degree Everest Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g 64942-1381_3b9c4383-7aa0-4388-9563-f8ea3b8aac28 64942-1381 HUMAN OTC DRUG Degree Extreme Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g 64942-1382_93c77b2d-78a7-434e-9b1d-ca07116cbde4 64942-1382 HUMAN OTC DRUG Degree Adventure Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g 64942-1383_436b2eaf-6ca6-48e9-9c17-f80e7b6cdfe9 64942-1383 HUMAN OTC DRUG Degree Sport Defense Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g 64942-1385_883c0098-a1a0-4be4-9ef4-eff2925501b9 64942-1385 HUMAN OTC DRUG Degree Overtime Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g 64942-1386_f60ebf00-cce9-404b-8606-6a34409275fb 64942-1386 HUMAN OTC DRUG Degree MotionSense Ironman Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1387_543a0ac9-7b30-490c-bb3b-ea79ca732531 64942-1387 HUMAN OTC DRUG Degree MotionSense Overtime Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1388_9c798a80-ed98-4b96-a24b-f3b15997490a 64942-1388 HUMAN OTC DRUG Degree MotionSense Cool Rush Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1389_6585dbc1-9b6f-48b5-a3d2-3fcb305dc83c 64942-1389 HUMAN OTC DRUG Degree MotionSense Adventure Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1390_1cfd6095-e710-4ef6-9d80-50537dfb5e71 64942-1390 HUMAN OTC DRUG Degree MotionSense Everest Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1391_f67d1fcd-5beb-4e9a-9409-7eec8f92364d 64942-1391 HUMAN OTC DRUG Degree MotionSense Extreme Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1392_b414587f-7284-47c9-bbf9-b2161b188d33 64942-1392 HUMAN OTC DRUG Degree MotionSense Sport Defense Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1393_2c292a22-8c61-45bb-b299-f2851c65cfc4 64942-1393 HUMAN OTC DRUG Dove Clinical Protection Powder Soft Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1394_82eb6e1d-ae02-4bba-8c86-cd9e5033bd40 64942-1394 HUMAN OTC DRUG Degree 5 In 1 Clinical Protection Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g 64942-1395_42573a60-30bd-47ce-91da-5e94809834d7 64942-1395 HUMAN OTC DRUG Dove Advanced Care Powder Soft Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1396_2682ff7d-c3d2-4a60-aa34-dff2b41fafd3 64942-1396 HUMAN OTC DRUG Dove Advanced Care Original Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1397_17bebc4b-13a3-4370-b053-56eef77df193 64942-1397 HUMAN OTC DRUG Dove Men plus Care Sensitive Shield Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 64942-1398_21c2a41a-72ad-4a0f-a93c-58f36438cab0 64942-1398 HUMAN OTC DRUG Degree Sexy Intrigue Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g 64942-1399_f1c5ace4-8e47-45b2-861e-972f5c5760f9 64942-1399 HUMAN OTC DRUG Degree Motion Sense Blossoming Orchid Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 64942-1400_eee73747-7e5c-43b0-a74e-2be2b0a81b32 64942-1400 HUMAN OTC DRUG Vaseline Lip Therapy Advanced Healing Petrolatum OINTMENT TOPICAL 20040120 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever PETROLATUM 100 g/100g 64944-0001_7d7eb52d-bfb7-42c6-8541-1ddadab353da 64944-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990319 UNAPPROVED MEDICAL GAS Seventh Street Medical Supply, Inc OXYGEN 99 L/100L 64950-230_a84ad934-f9bb-4f36-a103-be706788accd 64950-230 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20140401 ANDA ANDA065422 Lehigh Valley Technologies, Inc. NYSTATIN 100000 [USP'U]/15mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 64950-231_5c0d7336-b5c0-45eb-bde6-44347be46373 64950-231 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20140401 ANDA ANDA040610 Lehigh Valley Technologies, Inc. PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 64950-340_5ca44780-b262-4674-a854-5cbb0c844027 64950-340 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen SOLUTION ORAL 20140401 ANDA ANDA200343 Lehigh Valley Technologies, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII 64950-353_a0927b73-def2-49ed-8837-2f6775af38e9 64950-353 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20101020 NDA NDA200535 Lehigh Valley Technologies, Inc. OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 64950-354_a0927b73-def2-49ed-8837-2f6775af38e9 64950-354 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20130909 NDA NDA200535 Lehigh Valley Technologies, Inc. OXYCODONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 64950-901_668267e1-0a6a-44db-9c04-e10b7a1415b8 64950-901 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE ORAL 20101020 NDA NDA200534 Lehigh Valley Technologies, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 64960-000_44ab1122-a325-4576-93eb-23b6ba406783 64960-000 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130730 UNAPPROVED MEDICAL GAS King's Daughters Home Medical Equipment OXYGEN 1 L/L 64980-104_b01eac95-dbe3-4b21-a922-187e0fc8ad23 64980-104 HUMAN PRESCRIPTION DRUG Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate TABLET ORAL 20120628 UNAPPROVED DRUG OTHER Rising Pharmaceuticals, Inc. POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 155; 852; 130 mg/1; mg/1; mg/1 64980-111_d71749ac-d1f0-428f-a76e-088ceb20f794 64980-111 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20020813 ANDA ANDA072264 Rising Pharmaceuticals Inc BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 64980-112_d71749ac-d1f0-428f-a76e-088ceb20f794 64980-112 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20020813 ANDA ANDA072265 Rising Pharmaceuticals Inc BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 64980-113_d71749ac-d1f0-428f-a76e-088ceb20f794 64980-113 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20020813 ANDA ANDA072266 Rising Pharmaceuticals Inc BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 64980-119_83208464-0074-4d06-97a9-0f1b81071f1f 64980-119 HUMAN PRESCRIPTION DRUG Methenamine Hippurate Methenamine Hippurate TABLET ORAL 20030701 ANDA ANDA076411 Rising Pharmaceuticals Inc METHENAMINE HIPPURATE 1 g/1 64980-123_f0916642-a24d-4904-b73c-d1b8621ca5cd 64980-123 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20030930 ANDA ANDA040537 Rising Pharmaceuticals, Inc. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 64980-130_926d4fe4-5b4b-4fe9-ad30-106fdbed8f58 64980-130 HUMAN PRESCRIPTION DRUG LEVOCARNITINE LEVOCARNITINE TABLET ORAL 20040920 ANDA ANDA076858 Rising Pharmaceuticals, Inc. LEVOCARNITINE 330 mg/1 Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] 64980-131_6e88e74a-958d-4ea9-aeb1-362d0a2b4efe 64980-131 HUMAN PRESCRIPTION DRUG GLYCOPYRROLATE GLYCOPYRROLATE TABLET ORAL 20041230 ANDA ANDA040568 Rising Pharmaceuticals Inc GLYCOPYRROLATE 1 mg/1 64980-132_6e88e74a-958d-4ea9-aeb1-362d0a2b4efe 64980-132 HUMAN PRESCRIPTION DRUG GLYCOPYRROLATE GLYCOPYRROLATE TABLET ORAL 20041230 ANDA ANDA040568 Rising Pharmaceuticals Inc GLYCOPYRROLATE 2 mg/1 64980-133_20d311f1-430f-48b7-be0e-b5964118e397 64980-133 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20070805 ANDA ANDA040733 Rising Pharmaceuticals, Inc. DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 64980-134_20d311f1-430f-48b7-be0e-b5964118e397 64980-134 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20070213 ANDA ANDA040733 Rising Pharmaceuticals, Inc. DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 64980-135_20d311f1-430f-48b7-be0e-b5964118e397 64980-135 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20070213 ANDA ANDA040733 Rising Pharmaceuticals, Inc. DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 64980-137_5a9cf251-b0c0-4870-9650-12978969371e 64980-137 HUMAN PRESCRIPTION DRUG POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE ORAL 20060619 ANDA ANDA077440 Rising Pharmaceuticals, Inc. POTASSIUM CITRATE 540 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 64980-138_5a9cf251-b0c0-4870-9650-12978969371e 64980-138 HUMAN PRESCRIPTION DRUG POTASSIUM CITRATE POTASSIUM CITRATE TABLET, EXTENDED RELEASE ORAL 20060619 ANDA ANDA077440 Rising Pharmaceuticals, Inc. POTASSIUM CITRATE 1080 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 64980-139_6613bc89-c3f7-45fc-9c1c-98554f6c0c44 64980-139 HUMAN PRESCRIPTION DRUG URSODIOL URSODIOL CAPSULE ORAL 20061005 ANDA ANDA077895 Rising Pharmaceuticals, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 64980-140_44c65838-6074-48e2-bff3-61aa1d1f1241 64980-140 HUMAN PRESCRIPTION DRUG ALPRAZOLAM EXTENDED-RELEASE ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070328 ANDA ANDA077996 Rising Pharmaceuticals Inc ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64980-141_44c65838-6074-48e2-bff3-61aa1d1f1241 64980-141 HUMAN PRESCRIPTION DRUG ALPRAZOLAM EXTENDED-RELEASE ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070328 ANDA ANDA077996 Rising Pharmaceuticals Inc ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64980-142_44c65838-6074-48e2-bff3-61aa1d1f1241 64980-142 HUMAN PRESCRIPTION DRUG ALPRAZOLAM EXTENDED-RELEASE ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070328 ANDA ANDA077996 Rising Pharmaceuticals Inc ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64980-143_44c65838-6074-48e2-bff3-61aa1d1f1241 64980-143 HUMAN PRESCRIPTION DRUG ALPRAZOLAM EXTENDED-RELEASE ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070328 ANDA ANDA077996 Rising Pharmaceuticals Inc ALPRAZOLAM 3 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 64980-144_e0d79be0-c4ac-4030-bef0-730453ffc2cc 64980-144 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET, EXTENDED RELEASE ORAL 20080402 ANDA ANDA040723 Rising Pharmaceuticals Inc ISOSORBIDE DINITRATE 40 mg/1 64980-149_9907fe75-78ff-4386-80f1-15d5a67af395 64980-149 HUMAN PRESCRIPTION DRUG Probenecid and Colchicine Probenecid and Colchicine TABLET ORAL 20080513 ANDA ANDA040618 Rising Pharmaceuticals, Inc. COLCHICINE; PROBENECID .5; 500 mg/1; mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] 64980-151_b66c6a8c-914f-4ce4-a168-00d362cd0c38 64980-151 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride Amiloride Hydrochloride TABLET ORAL 20090501 ANDA ANDA079133 Rising Pharmaceuticals, Inc AMILORIDE HYDROCHLORIDE 5 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 64980-154_fffd3c9b-d7c8-4ba0-8527-3fdd742c69e6 64980-154 HUMAN PRESCRIPTION DRUG butalbital, acetominophen and caffeine butalbital, acetominophen and caffeine TABLET ORAL 20090708 ANDA ANDA040864 Rising Pharmaceuticals, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 64980-155_2af36469-aeb0-4d48-92c3-5c11e11fab79 64980-155 HUMAN PRESCRIPTION DRUG butalbital, acetominophen and caffeine butalbital, acetominophen and caffeine TABLET ORAL 20090427 ANDA ANDA040883 Rising Pharmaceuticals, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 64980-157_ea933bba-b3f6-4d37-8c23-d75d0c5cedc2 64980-157 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20100723 ANDA ANDA091004 Rising Pharamceuticals, Inc ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 64980-158_cf5acff1-0306-48e0-ad3e-8879cdbcc5f0 64980-158 HUMAN PRESCRIPTION DRUG Protriptyline Hydrochloride Protriptyline Hydrochloride TABLET, FILM COATED ORAL 20100611 ANDA ANDA090462 Rising Pharmaceuticals, Inc PROTRIPTYLINE HYDROCHLORIDE 5 mg/1 Tricyclic Antidepressant [EPC] 64980-159_cf5acff1-0306-48e0-ad3e-8879cdbcc5f0 64980-159 HUMAN PRESCRIPTION DRUG Protriptyline Hydrochloride Protriptyline Hydrochloride TABLET, FILM COATED ORAL 20100611 ANDA ANDA090462 Rising Pharmaceuticals, Inc PROTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 64980-160_db09e891-4325-4d2a-b7bb-0d9a0100434d 64980-160 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20100824 ANDA ANDA091256 Rising Pharmaceuticals Inc. BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 64980-161_db09e891-4325-4d2a-b7bb-0d9a0100434d 64980-161 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20100406 ANDA ANDA091256 Rising Pharmaceuticals Inc. BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 64980-162_db09e891-4325-4d2a-b7bb-0d9a0100434d 64980-162 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20100406 ANDA ANDA091256 Rising Pharmaceuticals Inc. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 64980-163_db09e891-4325-4d2a-b7bb-0d9a0100434d 64980-163 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20100406 ANDA ANDA091256 Rising Pharmaceuticals Inc. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 64980-166_c3e3542f-1d55-40c0-b0db-6a5c8b52c0d5 64980-166 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET ORAL 20110701 ANDA ANDA078329 Rising Pharmaceuticals, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 64980-167_c3e3542f-1d55-40c0-b0db-6a5c8b52c0d5 64980-167 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET ORAL 20110701 ANDA ANDA078329 Rising Pharmaceuticals, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 64980-168_c3e3542f-1d55-40c0-b0db-6a5c8b52c0d5 64980-168 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET ORAL 20110701 ANDA ANDA078329 Rising Pharmaceuticals, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 64980-169_11f81ed0-8025-48d3-8cfa-872744fb917a 64980-169 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 Rising Pharmaceuticals Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 64980-170_11f81ed0-8025-48d3-8cfa-872744fb917a 64980-170 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 Rising Pharmaceuticals Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 64980-171_12882f2f-40fd-4ed9-93f0-58bab90459ed 64980-171 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20110401 ANDA ANDA091619 Rising Pharmaceuticals, Inc. DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] 64980-172_12882f2f-40fd-4ed9-93f0-58bab90459ed 64980-172 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20110401 ANDA ANDA091619 Rising Pharmaceuticals, Inc. DISULFIRAM 500 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] 64980-174_d1db05b0-edcd-414c-b824-493226157b44 64980-174 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20100701 ANDA ANDA040823 Rising Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 64980-175_9d8b08a9-02c8-4b02-9e0e-a24b90d7a7e0 64980-175 HUMAN PRESCRIPTION DRUG CARISOPRODOL and ASPIRIN CARISOPRODOL and ASPIRIN TABLET ORAL 20100107 ANDA ANDA040832 Rising Pharmaceuticals, Inc. ASPIRIN; CARISOPRODOL 325; 200 mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 64980-176_cbe427b8-c405-4343-af60-c140e2a85884 64980-176 HUMAN PRESCRIPTION DRUG Carisoprodol, Aspirin and Codeine Phosphate Carisoprodol, Aspirin and Codeine Phosphate TABLET ORAL 20100110 ANDA ANDA040860 Rising Pharmaceuticals, Inc. ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE 325; 200; 16 mg/1; mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 64980-177_ee944d28-f596-4163-a502-e779c0d622bc 64980-177 HUMAN PRESCRIPTION DRUG Chloroquine Phosphate Chloroquine Phosphate TABLET ORAL 20110701 ANDA ANDA091621 Rising Pharmaceuticals, Inc. CHLOROQUINE PHOSPHATE 250 mg/1 Antimalarial [EPC] 64980-178_06c69e2b-211b-4746-9f3a-f86d36520570 64980-178 HUMAN PRESCRIPTION DRUG Chloroquine Phosphate Chloroquine Phosphate TABLET ORAL 20110701 ANDA ANDA090612 Rising Pharmaceuticals, Inc. CHLOROQUINE PHOSPHATE 500 mg/1 Antimalarial [EPC] 64980-179_01e8c52f-58a4-4924-b869-37967c0e2fca 64980-179 HUMAN PRESCRIPTION DRUG Flucytosine Flucytosine CAPSULE ORAL 20110715 ANDA ANDA201566 Rising Pharmaceuticals, Inc. FLUCYTOSINE 250 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] 64980-180_01e8c52f-58a4-4924-b869-37967c0e2fca 64980-180 HUMAN PRESCRIPTION DRUG Flucytosine Flucytosine CAPSULE ORAL 20110715 ANDA ANDA201566 Rising Pharmaceuticals, Inc. FLUCYTOSINE 500 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] 64980-181_65903da2-fdd1-4f8a-93e1-ca4e216c8ec3 64980-181 HUMAN PRESCRIPTION DRUG DIFLUNISAL DIFLUNISAL TABLET, FILM COATED ORAL 20120501 ANDA ANDA202845 Rising Pharmaceuticals Inc. DIFLUNISAL 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 64980-182_0ed99c62-aec3-4f3f-acb3-bd43c9d7ed4d 64980-182 HUMAN OTC DRUG Sodium Bicarbonate sodium bicarbonate TABLET, ORALLY DISINTEGRATING ORAL 20120626 OTC MONOGRAPH FINAL part331 Rising Pharmaceuticals, Inc. SODIUM BICARBONATE 650 mg/1 64980-183_f1959810-01c4-4cfd-a729-97d7b37d6654 64980-183 HUMAN PRESCRIPTION DRUG Tranylcypromine Sulfate tranylcypromine sulfate TABLET ORAL 20120109 NDA NDA012342 Rising Pharmaceuticals, Inc. TRANYLCYPROMINE SULFATE 10 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] 64980-184_46f4ea39-838d-4845-b58e-1849b73671e5 64980-184 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin TABLET ORAL 20121023 ANDA ANDA202545 Rising Pharmaceuticals, Inc GRISEOFULVIN 125 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 64980-185_46f4ea39-838d-4845-b58e-1849b73671e5 64980-185 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin TABLET ORAL 20121023 ANDA ANDA202545 Rising Pharmaceuticals, Inc GRISEOFULVIN 250 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 64980-186_42e6b77d-f803-40a2-be11-6d9dd327cf6a 64980-186 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin TABLET ORAL 20121023 ANDA ANDA202482 Rising Pharmaceuticals Inc. GRISEOFULVIN 500 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 64980-190_be22d79b-f60f-4e8d-898a-a8a37fe5fa1b 64980-190 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120921 ANDA ANDA091451 Rising Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 64980-191_a73367a9-124a-45a9-b93b-c8ee4f87a8ab 64980-191 HUMAN PRESCRIPTION DRUG Riluzole riluzole TABLET, FILM COATED ORAL 20130515 NDA AUTHORIZED GENERIC NDA020599 Rising Pharmaceuticals, Inc. RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] 64980-194_ddd1355c-3f75-4bc0-8567-c6131d85f2de 64980-194 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20140320 NDA AUTHORIZED GENERIC NDA020033 Rising Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 64980-195_ddd1355c-3f75-4bc0-8567-c6131d85f2de 64980-195 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20140320 NDA AUTHORIZED GENERIC NDA020033 Rising Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 64980-196_ddd1355c-3f75-4bc0-8567-c6131d85f2de 64980-196 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20140320 NDA AUTHORIZED GENERIC NDA020033 Rising Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 64980-301_fcd4747b-3c54-4b2f-a6bc-eafa0cf7016e 64980-301 HUMAN PRESCRIPTION DRUG Proctozone HC hydrocortisone CREAM TOPICAL 20120501 ANDA ANDA089682 Rising Pharmaceuticals, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 64980-302_a1148e9e-061c-4070-8059-68ffe3d3b20a 64980-302 HUMAN PRESCRIPTION DRUG Procto-Pak hydrocortisone CREAM TOPICAL 20120601 ANDA ANDA087795 Rising Pharmaceuticals, Inc. HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 64980-305_602c5345-5f9f-4155-b348-2754e836029b 64980-305 HUMAN PRESCRIPTION DRUG Denta 5000 Plus Sodium fluoride GEL, DENTIFRICE ORAL 20120713 UNAPPROVED DRUG OTHER Rising Pharmaceuticals, Inc. SODIUM FLUORIDE 1.1 g/100g 64980-306_602c5345-5f9f-4155-b348-2754e836029b 64980-306 HUMAN PRESCRIPTION DRUG Denta 5000 Plus Sodium fluoride GEL, DENTIFRICE ORAL 20120713 UNAPPROVED DRUG OTHER Rising Pharmaceuticals, Inc. SODIUM FLUORIDE 1.1 g/100g 64980-307_944faa31-3f0e-42cd-aa5f-22cd8ed1c131 64980-307 HUMAN PRESCRIPTION DRUG DentaGel Sodium fluoride GEL ORAL 20120501 UNAPPROVED DRUG OTHER Rising Pharmaceuticals, Inc. SODIUM FLUORIDE 1.1 g/100g 64980-320_cf28e9eb-545d-4f6b-b383-e99e9f7ba9a6 64980-320 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE TOPICAL 20100707 ANDA ANDA040771 Rising Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 64980-503_0b758028-9c7f-50c6-e054-00144ff88e88 64980-503 HUMAN PRESCRIPTION DRUG Levocarnitine Levocarnitine SOLUTION ORAL 20040920 ANDA ANDA076851 Rising Pharmaceuticals, Inc. LEVOCARNITINE 1 g/10mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] 64980-504_6db73ac3-9f43-4c1d-92d2-d2414ab08f90 64980-504 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride SYRUP ORAL 20060710 ANDA ANDA040668 Rising Pharmaceuticals, Inc. CYPROHEPTADINE HYDROCHLORIDE 2 mg/5mL 64980-506_8ba9cc1c-55e5-40ed-9efe-f7abb73976ea 64980-506 HUMAN PRESCRIPTION DRUG Flunisolide Flunisolide SPRAY, METERED NASAL 20061128 ANDA ANDA077704 Rising Pharmaceuticals, Inc FLUNISOLIDE .25 mg/mL 64980-509_f81caf82-a049-4bca-9eb1-716227ae3fde 64980-509 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone ELIXIR ORAL 20110801 ANDA ANDA090891 Rising Pharmaceuticals, Inc. DEXAMETHASONE .5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 64980-510_3f3d300d-a843-4da8-90d1-7a1a4c283c51 64980-510 HUMAN PRESCRIPTION DRUG Flunisolide Flunisolide SPRAY, METERED NASAL 20060803 ANDA ANDA077704 Rising Pharmaceuticals, Inc FLUNISOLIDE .25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 64980-511_1f9fe1a3-3c07-47c8-8692-4663ce382af7 64980-511 HUMAN PRESCRIPTION DRUG CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric) CLINDAMYCIN PALMITATE HYDROCHLORIDE GRANULE, FOR SOLUTION ORAL 20121001 ANDA ANDA201821 Rising Pharmaceuticals, Inc. CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 64980-513_860789c3-f543-4698-ad05-91d42b6f5f5e 64980-513 HUMAN PRESCRIPTION DRUG TIMOLOL MALEATE timolol maleate SOLUTION/ DROPS OPHTHALMIC 20141215 ANDA ANDA077259 Rising Pharmaceuticals, Inc. TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 64980-514_860789c3-f543-4698-ad05-91d42b6f5f5e 64980-514 HUMAN PRESCRIPTION DRUG TIMOLOL MALEATE timolol maleate SOLUTION/ DROPS OPHTHALMIC 20141215 ANDA ANDA077259 Rising Pharmaceuticals, Inc. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 64980-515_6757c17b-d1bc-4962-8324-13216f041c39 64980-515 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION OPHTHALMIC 20141215 ANDA ANDA078559 Rising Pharmaceuticals, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 64987-0296_a076f229-7380-4e8b-8ed1-24e16edecaa0 64987-0296 HUMAN OTC DRUG Antibacterial Skin Rain Forest Extract From Entiere TRICLOSAN SOAP TOPICAL 20140916 OTC MONOGRAPH NOT FINAL part333E World Club Supply Corp TRICLOSAN .2 mg/100mL 64990-385_99628a04-d6e0-4945-9022-cad7a8c27343 64990-385 HUMAN OTC DRUG Isomers DeoDry Antiperspirant Aluminum Chlorohydrate LOTION TOPICAL 20031028 OTC MONOGRAPH FINAL part350 Isomers laboratories Inc ALUMINUM CHLOROHYDRATE .0155 mL/mL 64990-601_6c40c51f-59d2-4d7d-971f-a9d256bd7bcd 64990-601 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Gel Salicylic Acid GEL TOPICAL 20091226 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL 64990-601_6cba7d97-428d-4655-a3cd-768a294d7ba5 64990-601 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Gel Salicylic Acid GEL TOPICAL 20091228 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL 64990-601_913fb3f3-02cc-4d28-8651-5e5e6f954070 64990-601 HUMAN OTC DRUG Isomers Clear Skin Acne Spot Treatment Salicylic Acid GEL TOPICAL 20100301 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL 64990-601_9532a7db-9aab-44ae-8e35-12d0e74b8f9b 64990-601 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Gel Salicylic Acid GEL TOPICAL 20091228 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL 64990-605_157c8677-4395-4066-908e-861e5a7b317f 64990-605 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Lotion Salicylic Acid LOTION TOPICAL 20091228 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL 64990-605_f0028189-5e3a-43b8-94d2-fd509b62343b 64990-605 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Lotion Salicylic Acid LOTION TOPICAL 20091226 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL 64990-605_f2a273b5-ab49-4c45-8f5b-ef9a3cecc1ed 64990-605 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Lotion Salicylic Acid LOTION TOPICAL 20091226 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL 64990-609_342c11fe-709c-4f84-a824-b230fd6216fa 64990-609 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Cleanser Salicylic Acid LIQUID TOPICAL 20130425 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc. SALICYLIC ACID 20 mg/mL 64990-609_6de665eb-7991-4f17-b07e-ee443eacb9bf 64990-609 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Cleanser Salicylic Acid LIQUID TOPICAL 20100120 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL 64990-609_8d064ebe-1ded-4c54-8076-196985d2d84d 64990-609 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Cleanser Salicylic Acid LIQUID TOPICAL 20100120 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL 64990-610_e27f0f29-4133-4029-8cb9-df01734444b2 64990-610 HUMAN OTC DRUG Clear Skin Acne Treatment Salicylic Acid LOTION TOPICAL 20120427 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc. SALICYLIC ACID 20 mg/mL 64990-885_96e49b7c-2cf2-4b6f-b7ad-9fb25014d61a 64990-885 HUMAN OTC DRUG Isomers Sunscreen with UV pearls Broad Spectrm SPF 20 Zinc Oxide, Octinoxate LOTION TOPICAL 20030331 OTC MONOGRAPH NOT FINAL part352 Isomers Laboratories Inc OCTINOXATE; ZINC OXIDE 75; 80 mg/mL; mg/mL 64997-050_69b58ad6-892b-457a-bbb8-9f93e3fd62b4 64997-050 HUMAN OTC DRUG Kids Travel Sickness Cocculus 30C, Nux Vomica 30C, Borax 6C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES JATEORHIZA CALUMBA ROOT; SODIUM BORATE; STRYCHNOS NUX-VOMICA SEED 30; 6; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 64997-100_60671a69-e7ab-48d1-b701-179d405a2b85 64997-100 HUMAN OTC DRUG kids throat Aconite 30C, Belladonna 30C, Chamomilla 30C, Phytolacca 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES ACONITUM NAPELLUS; BELLADONNA LEAF; MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 64997-150_43bac331-4a26-49fa-acd9-46512f784a1d 64997-150 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES ATROPA BELLADONNA; DROSERA INTERMEDIA; IPECAC; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS WHOLE 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 64997-152_6533959c-0e9b-493c-8b69-c476b16c19be 64997-152 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES ATROPA BELLADONNA; DROSERA INTERMEDIA; IPECAC; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS WHOLE 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 64997-180_2a0b9f7d-22bf-4948-9d4c-5427a673dcd1 64997-180 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES ATROPA BELLADONNA; DROSERA INTERMEDIA; IPECAC; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS WHOLE 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 64997-200_26296285-c013-4145-9505-1d513cebe195 64997-200 HUMAN OTC DRUG kids cold Allium Cepa 30C, Kali Bichromium 30C, Kali Sulphuricum 30C, Nux Vomica 30C, Natrum Muriaticum 30C, Pulsatilla 30C, Silicea 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES ONION; POTASSIUM DICHROMATE; POTASSIUM SULFATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 64997-300_4df10b5e-4401-4b6f-905a-a8037c30eca7 64997-300 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipecacuhuana 30C, Pulsatilla 30C, Belladonna 30C KIT 20140430 UNAPPROVED HOMEOPATHIC KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES 64997-400_23a19922-eaa3-41f2-a2e7-4a62a33e7805 64997-400 HUMAN OTC DRUG kids cough cold and throat Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C KIT 20140430 UNAPPROVED HOMEOPATHIC KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES 65003-006_f9b9f621-52a1-4296-8d64-08ecc56810cf 65003-006 HUMAN OTC DRUG StarCap Medical Private Limited Isopropyl Alcohol SWAB TOPICAL 20140604 OTC MONOGRAPH FINAL part344 StarCap Medical Private Limited ISOPROPYL ALCOHOL 70 g/100g 65003-007_5f6df9aa-249f-45be-b1af-3de034c3d959 65003-007 HUMAN OTC DRUG StarCap Medical Private Limited Isopropyl Alcohol SWAB TOPICAL 20140606 OTC MONOGRAPH FINAL part344 StarCap Medical Private Limited ISOPROPYL ALCOHOL 70 g/100g 65003-008_0a260e6d-ee44-4813-9a3f-9659ffbc3713 65003-008 HUMAN OTC DRUG StarCap Medical Private Limited Isopropyl Alcohol SWAB TOPICAL 20140606 OTC MONOGRAPH FINAL part344 StarCap Medical Private Limited ISOPROPYL ALCOHOL 70 g/100g 65003-018_59c8ee0d-dadd-4cf4-960f-f1f66cc282fd 65003-018 HUMAN OTC DRUG StarCap Medical Private Limited Isopropyl Alcohol SWAB TOPICAL 20140607 OTC MONOGRAPH FINAL part344 StarCap Medical Private Limited ISOPROPYL ALCOHOL 70 g/100g 65008-001_b008b961-b10f-4372-aa87-dd9e54f9663f 65008-001 HUMAN OTC DRUG Comfortcaine Lidocaine GEL TOPICAL 20041112 OTC MONOGRAPH NOT FINAL part348 QS Key West Aloe, LLC LIDOCAINE 40 mg/g 65010-001_e75863d2-7764-4e86-bed4-2564f181016d 65010-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19930101 NDA NDA205849 Technical Gas Products, Inc. OXYGEN 999 mL/L 65028-001_1fc97cf8-e035-4857-880b-4f3309422805 65028-001 HUMAN OTC DRUG Full Care Povidone Iodine Swabsticks POVIDONE-IODINE SWAB TOPICAL 20140422 OTC MONOGRAPH FINAL part333C Shaoxing Fuqing Health Products Co., Ltd. POVIDONE-IODINE .2 g/1 65028-002_f59c60c9-393e-43ab-a47f-363a0ff45646 65028-002 HUMAN OTC DRUG Full Care BZK Towelette BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20140422 OTC MONOGRAPH NOT FINAL part333A Shaoxing Fuqing Health Products Co., Ltd. BENZALKONIUM CHLORIDE .0026 g/2mL 65028-003_30f488ef-150d-4410-afba-389950675187 65028-003 HUMAN OTC DRUG Full Care Alcohol Swabsticks ISOPROPYL ALCOHOL SOLUTION TOPICAL 20140822 OTC MONOGRAPH NOT FINAL part333A Shaoxing Fuqing Health Products Co., Ltd. ISOPROPYL ALCOHOL 1.4 g/2mL 65028-004_877c7550-3275-4796-893b-053383328122 65028-004 HUMAN OTC DRUG Full Care Alcohol Prep Pad ISOPROPYL ALCOHOL SOLUTION TOPICAL 20140822 OTC MONOGRAPH NOT FINAL part333A Shaoxing Fuqing Health Products Co., Ltd. ISOPROPYL ALCOHOL .14 g/.2mL 65028-005_919a6cc7-2144-4e8e-87ff-3a3d6dead01d 65028-005 HUMAN OTC DRUG Full Care Three Povidone Iodine Swabsticks POVIDONE-IODINE SWAB TOPICAL 20140912 OTC MONOGRAPH FINAL part333C Shaoxing Fuqing Health Products Co., Ltd. POVIDONE-IODINE .2 g/1 65028-006_7ec39d5a-8573-476d-9f96-4a63be9b03f0 65028-006 HUMAN OTC DRUG Full Care Povidone Iodine Solution POVIDONE-IODINE SOLUTION TOPICAL 20140922 OTC MONOGRAPH FINAL part333C Shaoxing Fuqing Health Products Co., Ltd. POVIDONE-IODINE 1 g/100mL 65028-007_7f9837d5-2686-4f22-8ac9-dd36d5288f39 65028-007 HUMAN OTC DRUG Full Care Povidone Iodine Prep Pad POVIDONE-IODINE SOLUTION TOPICAL 20141017 OTC MONOGRAPH FINAL part333C Shaoxing Fuqing Health Products Co., Ltd. POVIDONE-IODINE .01 g/mL 65044-0537_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0537 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Bermuda Grass Standardized Grass Pollen, Bermuda Grass INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103872 Jubilant HollisterStier LLC CYNODON DACTYLON POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0538_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0538 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Bermuda Grass Standardized Grass Pollen, Bermuda Grass INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103872 Jubilant HollisterStier LLC CYNODON DACTYLON POLLEN 100 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0545_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0545 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Bluegrass, Kentucky (June) Standardized Grass Pollen, Bluegrass, Kentucky (June) INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0546_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0546 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Bluegrass, Kentucky (June) Standardized Grass Pollen, Bluegrass, Kentucky (June) INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0547_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0547 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Bluegrass, Kentucky (June) Standardized Grass Pollen, Bluegrass, Kentucky (June) INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN 100 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0548_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0548 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Bluegrass, Kentucky (June) Standardized Grass Pollen, Bluegrass, Kentucky (June) INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN 1000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0611_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0611 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Fescue, Meadow Standardized Grass Pollen, Fescue, Meadow INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103874 Jubilant HollisterStier LLC FESTUCA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0612_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0612 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Fescue, Meadow Standardized Grass Pollen, Fescue, Meadow INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103874 Jubilant HollisterStier LLC FESTUCA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0613_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0613 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Fescue, Meadow Standardized Grass Pollen, Fescue, Meadow INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103874 Jubilant HollisterStier LLC FESTUCA PRATENSIS POLLEN 100 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0614_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0614 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Fescue, Meadow Standardized Grass Pollen, Fescue, Meadow INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103874 Jubilant HollisterStier LLC FESTUCA PRATENSIS POLLEN 1000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0718_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0718 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Orchard Grass Standardized Grass Pollen, Orchard Grass INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103875 Jubilant HollisterStier LLC DACTYLIS GLOMERATA POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0719_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0719 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Orchard Grass Standardized Grass Pollen, Orchard Grass INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103875 Jubilant HollisterStier LLC DACTYLIS GLOMERATA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0720_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0720 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Orchard Grass Standardized Grass Pollen, Orchard Grass INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103875 Jubilant HollisterStier LLC DACTYLIS GLOMERATA POLLEN 100 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0721_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0721 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Orchard Grass Standardized Grass Pollen, Orchard Grass INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103875 Jubilant HollisterStier LLC DACTYLIS GLOMERATA POLLEN 1000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0777_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0777 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Redtop Standardized Grass Pollen, Redtop INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103876 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0778_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0778 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Redtop Standardized Grass Pollen, Redtop INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103876 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0779_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0779 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Redtop Standardized Grass Pollen, Redtop INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103876 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN 100 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0780_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0780 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Redtop Standardized Grass Pollen, Redtop INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103876 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN 1000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0787_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0787 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Ryegrass Standardized Grass Pollen, Ryegrass INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103877 Jubilant HollisterStier LLC LOLIUM PERENNE POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0788_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0788 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Ryegrass Standardized Grass Pollen, Ryegrass INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103877 Jubilant HollisterStier LLC LOLIUM PERENNE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0789_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0789 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Ryegrass Standardized Grass Pollen, Ryegrass INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103877 Jubilant HollisterStier LLC LOLIUM PERENNE POLLEN 100 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0790_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0790 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Ryegrass Standardized Grass Pollen, Ryegrass INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103877 Jubilant HollisterStier LLC LOLIUM PERENNE POLLEN 1000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0825_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0825 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Sweet Vernal Grass Standardized Grass Pollen, Sweet Vernal Grass INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103878 Jubilant HollisterStier LLC ANTHOXANTHUM ODORATUM POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0826_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0826 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Sweet Vernal Grass Standardized Grass Pollen, Sweet Vernal Grass INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103878 Jubilant HollisterStier LLC ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0827_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0827 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Sweet Vernal Grass Standardized Grass Pollen, Sweet Vernal Grass INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103878 Jubilant HollisterStier LLC ANTHOXANTHUM ODORATUM POLLEN 100 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0828_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0828 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Sweet Vernal Grass Standardized Grass Pollen, Sweet Vernal Grass INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103878 Jubilant HollisterStier LLC ANTHOXANTHUM ODORATUM POLLEN 1000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0831_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0831 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Timothy Standardized Grass Pollen, Timothy INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103879 Jubilant HollisterStier LLC PHLEUM PRATENSE POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0832_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0832 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Timothy Standardized Grass Pollen, Timothy INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103879 Jubilant HollisterStier LLC PHLEUM PRATENSE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0833_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0833 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Timothy Standardized Grass Pollen, Timothy INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103879 Jubilant HollisterStier LLC PHLEUM PRATENSE POLLEN 100 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0834_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0834 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Timothy Standardized Grass Pollen, Timothy INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103879 Jubilant HollisterStier LLC PHLEUM PRATENSE POLLEN 1000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0841_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0841 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Grass Mix 4 Standardized Grass Pollen, Grass Mix 4 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103873 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 2500; 2500; 2500; 2500 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0842_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0842 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Grass Mix 4 Standardized Grass Pollen, Grass Mix 4 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103873 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 25000; 25000; 25000; 25000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0843_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0843 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Grass Mix 4 Standardized Grass Pollen, Grass Mix 4 INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103873 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 25; 25; 25; 25 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0844_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0844 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Grass Mix 4 Standardized Grass Pollen, Grass Mix 4 INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103873 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 250; 250; 250; 250 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0845_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0845 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Grass Mix 5 Standardized Grass Pollen, Grass Mix 5 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103873 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 2000; 2000; 2000; 2000; 2000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0846_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0846 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Grass Mix 5 Standardized Grass Pollen, Grass Mix 5 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980105 BLA BLA103873 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 20000; 20000; 20000; 20000; 20000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0847_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0847 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Grass Mix 5 Standardized Grass Pollen, Grass Mix 5 INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103873 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 20; 20; 20; 20; 20 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0848_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0848 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Grass Mix 5 Standardized Grass Pollen, Grass Mix 5 INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103873 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 200; 200; 200; 200; 200 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0850_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0850 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Grass Mix 7 Standardized Grass Pollen, Grass Mix 7 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103873 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 1428; 1428; 1428; 1428; 1428; 1428; 1428 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0851_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0851 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Grass Mix 7 Standardized Grass Pollen, Grass Mix 7 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980105 BLA BLA103873 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 14285; 14285; 14285; 14285; 14285; 14285; 14285 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0852_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0852 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Grass Mix 7 Standardized Grass Pollen, Grass Mix 7 INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103873 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 14; 14; 14; 14; 14; 14; 14 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0853_0e653824-fba5-4e73-abe7-02fc9b55866c 65044-0853 HUMAN PRESCRIPTION DRUG Standardized Grass Pollen, Grass Mix 7 Standardized Grass Pollen, Grass Mix 7 INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103873 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 142; 142; 142; 142; 142; 142; 142 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0854_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-0854 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Southern Grass Mix Pollens - Grasses, Southern Grass Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN 100000; 100000; 10000; 100000; 100000; 100000; .05 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0855_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-0855 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Southern Grass Mix Pollens - Grasses, Southern Grass Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN 100000; 100000; 10000; 100000; 100000; 100000; .05 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0856_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-0856 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Southern Grass Mix 10th of concentrate Pollens - Grasses, Southern Grass Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN 10000; 10000; 1000; 10000; 10000; 10000; .005 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0857_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-0857 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Southern Grass Mix 10th of Concentrate Pollens - Grasses, Southern Grass Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN 10000; 10000; 1000; 10000; 10000; 10000; .005 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-0879_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-0879 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Grass Mix 8 Grass Mix 8 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN 100000; 10000; 100000; 100000; .05 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1006_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1006 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Acacia Acacia longifolia Acacia longifolia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACACIA LONGIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1007_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1007 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Acacia Acacia longifolia Acacia longifolia INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACACIA LONGIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1008_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1008 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Acacia Acacia longifolia Acacia longifolia INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACACIA LONGIFOLIA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1018_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1018 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Alder, Red Alnus rubra Alder, Red Alnus rubra INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALNUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1019_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1019 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Alder, Red Alnus rubra Alder, Red Alnus rubra INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALNUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1020_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1020 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Alder, Red Alnus rubra Alder, Red Alnus rubra INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALNUS RUBRA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1021_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1021 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Alder, Red Alnus rubra Alder, Red Alnus rubra INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALNUS RUBRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1060_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1060 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Ash, White Fraxinus americana Ash, White Fraxinus americana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1061_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1061 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Ash, White Fraxinus americana Ash, White Fraxinus americana INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1062_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1062 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Ash, White Fraxinus americana Ash, White Fraxinus americana INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1081_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1081 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Bahia Grass Paspalum notatum Bahia Grass Paspalum notatum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PASPALUM NOTATUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1082_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1082 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Bahia Grass Paspalum notatum Bahia Grass Paspalum notatum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PASPALUM NOTATUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1083_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1083 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Bahia Grass Paspalum notatum Bahia Grass Paspalum notatum INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC PASPALUM NOTATUM POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1084_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1084 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Bahia Grass Paspalum notatum Bahia Grass Paspalum notatum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PASPALUM NOTATUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1120_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1120 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Beech, American Fagus grandifolia Beech, American Fagus grandifolia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FAGUS GRANDIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1121_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1121 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Beech, American Fagus grandifolia Beech, American Fagus grandifolia INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FAGUS GRANDIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1168_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1168 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Birch Mix Birch Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1169_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1169 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Birch Mix Birch Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1170_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1170 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Birch Mix Birch Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1171_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1171 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Birch Mix Birch Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1172_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1172 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Birch Mix Birch Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN 40000; 20000; 40000 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1207_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1207 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Bottle Brush Callistemon spp. Bottle Brush Callistemon spp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CALLISTEMON CITRINUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1208_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1208 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Bottlebrush, Callistemon spp. Bottlebrush, Callistemon citrinus INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CALLISTEMON CITRINUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1213_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1213 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Boxelder/Maple Mix Boxelder/Maple Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARUM POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1214_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1214 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Boxelder/Maple Mix Boxelder/Maple Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARUM POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1215_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1215 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Boxelder/Maple Mix Boxelder/Maple Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARUM POLLEN 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1216_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1216 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Boxelder/Maple Mix Boxelder/Maple Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARUM POLLEN .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1217_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1217 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Boxelder/Maple Mix Boxelder/Maple Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARUM POLLEN 40000; 40000; 40000 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1237_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1237 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Brome, Smooth Bromus inermis Brome, Smooth Bromus inermis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1238_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1238 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Brome, Smooth Bromus inermis Brome, Smooth Bromus inermis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1297_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1297 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Careless Weed Amaranthus palmeri Careless Weed Amaranthus palmeri INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1298_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1298 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Careless Weed Amaranthus palmeri Careless Weed Amaranthus palmeri INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1300_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1300 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Careless/Pigweed Mix Careless/Pigweed Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1301_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1301 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Careless/Pigweed Mix Careless/Pigweed Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1302_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1302 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Careless/Pigweed Mix Careless/Pigweed Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN 500; 500 [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1303_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1303 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Careless/Pigweed Mix Careless/Pigweed Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN .1; .1 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1336_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1336 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cedar, Mountain Juniperus ashei Cedar, Mountain Juniperus ashei INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1337_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1337 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cedar, Mountain Juniperus ashei Cedar, Mountain Juniperus ashei INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1338_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1338 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cedar, Mountain Juniperus ashei Cedar, Mountain Juniperus ashei INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUNIPERUS ASHEI POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1339_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1339 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cedar, Mountain Juniperus ashei Cedar, Mountain Juniperus ashei INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUNIPERUS ASHEI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1340_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1340 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cedar, Red Juniperus virginiana Cedar, Red Juniperus virginiana INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1341_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1341 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cedar, Red Juniperus virginiana Cedar, Red Juniperus virginiana INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUNIPERUS VIRGINIANA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1342_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1342 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cedar, Red Juniperus virginiana Cedar, Red Juniperus virginiana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUNIPERUS VIRGINIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1343_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1343 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cedar, Red Juniperus virginiana Cedar, Red Juniperus virginiana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1405_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1405 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Cocklebur Xanthium strumarium Cocklebur Xanthium strumarium INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC XANTHIUM STRUMARIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1406_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1406 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Cocklebur Xanthium strumarium Cocklebur Xanthium strumarium INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC XANTHIUM STRUMARIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1407_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1407 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Cocklebur Xanthium strumarium Cocklebur Xanthium strumarium INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC XANTHIUM STRUMARIUM POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1408_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1408 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Cocklebur Xanthium strumarium Cocklebur Xanthium strumarium INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC XANTHIUM STRUMARIUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1409_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1409 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Cocklebur Xanthium strumarium Cocklebur Xanthium strumarium INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC XANTHIUM STRUMARIUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1414_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1414 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Corn, Cultivated Zea mays Corn, Cultivated Zea mays INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ZEA MAYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1415_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1415 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Corn, Cultivated Zea mays Corn, Cultivated Zea mays INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ZEA MAYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1435_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1435 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cottonwood, Common Populus deltoides Cottonwood, Common Populus deltoides INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1436_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1436 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cottonwood, Common Populus deltoides Cottonwood, Common Populus deltoides INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1437_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1437 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cottonwood, Common Populus deltoides Cottonwood, Common Populus deltoides INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC POPULUS DELTOIDES POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1438_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1438 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cottonwood, Common Populus deltoides Cottonwood, Common Populus deltoides INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POPULUS DELTOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1450_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1450 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cypress, Arizona Cupressus arizonica Cypress, Arizona Cupressus arizonica INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CUPRESSUS ARIZONICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1451_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1451 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cypress, Arizona Cupressus arizonica Cypress, Arizona Cupressus arizonica INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CUPRESSUS ARIZONICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1453_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1453 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cypress, Bald Taxodium distichum Cypress, Bald Taxodium distichum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TAXODIUM DISTICHUM POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1454_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1454 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cypress, Bald Taxodium distichum Cypress, Bald Taxodium distichum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TAXODIUM DISTICHUM POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1516_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1516 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Dock/Sorrel Mix Pollens - Weeds, Dock/Sorrel Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 65044-1517_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1517 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Dock/Sorrel Mix Pollens - Weeds, Dock/Sorrel Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 65044-1518_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1518 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Dock/Sorrel Mix Pollens - Weeds, Dock/Sorrel Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN 500; 500 [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 65044-1519_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1519 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Dock/Sorrel Mix Pollens - Weeds, Dock/Sorrel Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN .1; .1 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 65044-1520_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1520 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Dock/Sorrel Mix Pollens - Weeds, Dock/Sorrel Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN 20000; 20000 [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 65044-1540_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1540 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Elm, American Ulmus americana Elm, American Ulmus americana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ULMUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1541_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1541 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Elm, American Ulmus americana Elm, American Ulmus americana INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ULMUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1542_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1542 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Elm, American Ulmus americana Elm, American Ulmus americana INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ULMUS AMERICANA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1543_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1543 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Elm, American Ulmus americana Elm, American Ulmus americana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ULMUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1544_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1544 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Elm, American Ulmus americana Elm, American Ulmus americana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ULMUS AMERICANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1546_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1546 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Elm, Chinese Ulmus parvifolia Elm, Chinese Ulmus parvifolia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ULMUS PARVIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1547_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1547 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Elm, Chinese Ulmus parvifolia Elm, Chinese Ulmus parvifolia INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ULMUS PARVIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1548_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1548 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Elm, Chinese Ulmus parvifolia Elm, Chinese Ulmus parvifolia INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ULMUS PARVIFOLIA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1564_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1564 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Eucalyptus (Blue Gum) Eucalyptus globulus Eucalyptus (Blue Gum) Eucalyptus globulus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EUCALYPTUS GLOBULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1565_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1565 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Eucalyptus (Blue Gum) Eucalyptus globulus Eucalyptus (Blue Gum) Eucalyptus globulus INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EUCALYPTUS GLOBULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1630_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1630 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Goldenrod Solidago canadensis Goldenrod Solidago canadensis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLIDAGO CANADENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1631_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1631 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Goldenrod Solidago canadensis Goldenrod Solidago canadensis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLIDAGO CANADENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1632_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1632 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Goldenrod Solidago canadensis Goldenrod Solidago canadensis INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLIDAGO CANADENSIS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1660_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1660 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Gum, Sweet Liquidambar styraciflua Gum, Sweet Liquidambar styraciflua INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC LIQUIDAMBAR STYRACIFLUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1661_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1661 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Gum, Sweet Liquidambar styraciflua Gum, Sweet Liquidambar styraciflua INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC LIQUIDAMBAR STYRACIFLUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1662_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1662 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Gum, Sweet Liquidambar styraciflua Gum, Sweet Liquidambar styraciflua INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC LIQUIDAMBAR STYRACIFLUA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1663_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1663 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Hackberry Celtis occidentalis Hackberry Celtis occidentalis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CELTIS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1664_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1664 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Hackberry Celtis occidentalis Hackberry Celtis occidentalis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CELTIS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1665_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1665 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Hackberry Celtis occidentalis Hackberry Celtis occidentalis INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC CELTIS OCCIDENTALIS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1702_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1702 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Hickory, Shagbark Carya ovata Hickory, Shagbark Carya ovata INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA OVATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1703_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1703 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Hickory, Shagbark Carya ovata Hickory, Shagbark Carya ovata INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA OVATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1744_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1744 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Johnson Grass Sorghum halepense Johnson Grass Sorghum halepense INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SORGHUM HALEPENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1745_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1745 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Johnson Grass Sorghum halepense Johnson Grass Sorghum halepense INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SORGHUM HALEPENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1746_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1746 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Johnson Grass Sorghum halepense Johnson Grass Sorghum halepense INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC SORGHUM HALEPENSE POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1747_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1747 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Johnson Grass Sorghum halepense Johnson Grass Sorghum halepense INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SORGHUM HALEPENSE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1780_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1780 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Kochia scoparia Kochia scoparia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BASSIA SCOPARIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1781_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1781 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Kochia scoparia Kochia scoparia INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BASSIA SCOPARIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1782_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1782 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Kochia scoparia Kochia scoparia INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC BASSIA SCOPARIA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1783_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1783 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Kochia scoparia Kochia scoparia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BASSIA SCOPARIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1786_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1786 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Lambs Quarters Chenopodium album Lambs Quarters Chenopodium album INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1787_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1787 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Lamb Quarters Chenopodium album Lamb Quarters Chenopodium album INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1788_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1788 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Lamb Quarters Chenopodium album Lamb Quarters Chenopodium album INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC CHENOPODIUM ALBUM POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1789_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1789 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Lambs Quarters Chenopodium album Lambs Quarters Chenopodium album INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CHENOPODIUM ALBUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1790_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1790 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Lambs Quarters Chenopodium album Lambs Quarters Chenopodium album INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CHENOPODIUM ALBUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1791_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1791 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Lambs Quarters Chenopodium album Lambs Quarters Chenopodium album INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CHENOPODIUM ALBUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1801_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1801 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Linden (Basswood) Tilia americana Linden (Basswood) Tilia americana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TILIA AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1802_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1802 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Linden (Basswood) Tilia americana Linden (Basswood) Tilia americana INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TILIA AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1831_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1831 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Maple, Hard Acer saccharum Maple, Hard Acer saccharum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER SACCHARUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1832_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1832 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Maple, Hard Acer saccharum Maple, Hard Acer saccharum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER SACCHARUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1833_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1833 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Maple, Hard Acer saccharum Maple, Hard Acer saccharum INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER SACCHARUM POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1858_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1858 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Marshelder/Poverty Mix Pollens - Weeds, Marshelder/Poverty Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CYCLACHAENA XANTHIFOLIA POLLEN; IVA ANNUA POLLEN; IVA AXILLARIS POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1859_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1859 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Marshelder/Poverty Mix Pollens - Weeds, Marshelder/Poverty Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CYCLACHAENA XANTHIFOLIA POLLEN; IVA ANNUA POLLEN; IVA AXILLARIS POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1860_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1860 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Marshelder/Poverty Mix Pollens - Weeds, Marshelder/Poverty Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC CYCLACHAENA XANTHIFOLIA POLLEN; IVA ANNUA POLLEN; IVA AXILLARIS POLLEN 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1861_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1861 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Marshelder/Poverty Mix Pollens - Weeds, Marshelder/Poverty Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CYCLACHAENA XANTHIFOLIA POLLEN; IVA ANNUA POLLEN; IVA AXILLARIS POLLEN .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1873_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1873 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Melaleuca (Punk Tree) Melaleuca quinquenervia Melaleuca (Punk Tree) Melaleuca quinquenervia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC MELALEUCA QUINQUENERVIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1874_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1874 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Melaleuca (Punk Tree) Melaleuca quinquenervia Melaleuca, Melaleuca quinquenervia INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC MELALEUCA QUINQUENERVIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1876_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1876 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Mesquite, Prosopis juliflora Mesquite, Prosopis juliflora INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PROSOPIS JULIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1877_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1877 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Mesquite, Prosopis juliflora Mesquite, Prosopis juliflora INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PROSOPIS JULIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1878_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1878 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Mesquite, Prosopis juliflora Mesquite, Prosopis juliflora INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC PROSOPIS JULIFLORA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1909_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1909 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Mulberry Mix Mulberry Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC MORUS ALBA POLLEN; MORUS RUBRA POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1910_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1910 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Mulberry Mix Mulberry Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC MORUS ALBA POLLEN; MORUS RUBRA POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1911_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-1911 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Mulberry Mix Mulberry Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC MORUS ALBA POLLEN; MORUS RUBRA POLLEN 500; 500 [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1912_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1912 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Mulberry Mix Mulberry Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC MORUS ALBA POLLEN; MORUS RUBRA POLLEN .1; .1 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1945_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1945 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Nettle Urtica dioica Nettle Urtica dioica INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC URTICA DIOICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1946_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-1946 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Nettle Urtica dioica Nettle Urtica dioica INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC URTICA DIOICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-1947_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-1947 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Nettle Urtica dioica Nettle Urtica dioica INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC URTICA DIOICA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2014_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2014 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Oak, Red Quercus rubra Oak, Red Quercus rubra INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUERCUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2015_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2015 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Oak, Red Quercus rubra Oak, Red Quercus rubra INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUERCUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2016_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2016 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Oak, Red Quercus rubra Oak, Red Quercus rubra INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUERCUS RUBRA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2017_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2017 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Palo Verde Cercidium floridum Palo Verde Cercidium floridum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PARKINSONIA FLORIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2018_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2018 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Palo Verde Cercidium floridum Palo Verde Cercidium floridum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PARKINSONIA FLORIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2035_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2035 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Oak Mix Oak Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2036_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2036 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Oak Mix Oak Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2037_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2037 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Oak Mix Oak Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2038_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2038 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Oak Mix Oak Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2039_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2039 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Oak Mix Oak Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2041_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2041 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Oats, Common, Cultivated Avena sativa Oats, Common, Cultivated Avena sativa INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AVENA SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2042_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2042 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Oats, Common, Cultivated Avena sativa Oats, Common, Cultivated Avena sativa INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AVENA SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2050_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2050 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Olive Olea europaea Olive Olea europaea INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC OLEA EUROPAEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2051_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2051 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Olive Olea europaea Olive Olea europaea INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC OLEA EUROPAEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2052_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2052 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Olive Olea europaea Olive Olea europaea INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC OLEA EUROPAEA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2053_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2053 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Olive Olea europaea Olive Olea europaea INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC OLEA EUROPAEA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2057_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2057 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Dog Fennel, Eastern Eupatorium capillifolium Dog Fennel, Eastern Eupatorium capillifolium INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EUPATORIUM CAPILLIFOLIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2058_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2058 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Dog Fennel Eupatorium capillifolium Dog Fennel Eupatorium capillifolium INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EUPATORIUM CAPILLIFOLIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2074_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2074 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Palm, Queen Cocos plumosa Palm, Queen Cocos plumosa INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SYAGRUS ROMANZOFFIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2075_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2075 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Palm, Queen Cocos plumosa Palm, Queen Cocos plumosa INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SYAGRUS ROMANZOFFIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2098_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2098 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Pecan Carya Carya illinoensis Pecan Carya Carya illinoensis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA ILLINOINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2099_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2099 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Pecan Carya Carya illinoensis Pecan Carya Carya illinoensis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA ILLINOINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2100_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2100 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Pecan Carya Carya illinoensis Pecan Carya Carya illinoensis INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA ILLINOINENSIS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2101_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2101 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Pecan Carya Carya illinoensis Pecan Carya Carya illinoensis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA ILLINOINENSIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2107_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2107 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Pepper Tree, California Schinus molle Pepper Tree, California Schinus molle INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SCHINUS MOLLE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2108_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2108 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Pepper Tree, California Schinus molle Pepper Tree, California Schinus molle INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SCHINUS MOLLE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2125_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2125 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Pigweed, Rough Redroot Amaranthus retroflexus Pigweed, Rough Redroot Amaranthus retroflexus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2126_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2126 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Pigweed, Rough Redroot Amaranthus retroflexus Pigweed, Rough Redroot Amaranthus retroflexus INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2127_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2127 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Pigweed, Rough Redroot Amaranthus retroflexus Pigweed, Rough Redroot Amaranthus retroflexus INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS RETROFLEXUS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2203_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2203 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Pine Mix Pine Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PINUS CONTORTA POLLEN; PINUS PONDEROSA POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2204_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2204 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Pine Mix Pine Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PINUS CONTORTA POLLEN; PINUS PONDEROSA POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2212_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2212 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Plantain, English Plantago lanceolata Plantain, English Plantago lanceolata INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLANTAGO LANCEOLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2213_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2213 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Plantain, English Plantago lanceolata Plantain, English Plantago lanceolata INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLANTAGO LANCEOLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2214_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2214 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Plantain, English Plantago lanceolata Plantain, English Plantago lanceolata INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLANTAGO LANCEOLATA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2215_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2215 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Plantain, English Plantago lanceolata Plantain, English Plantago lanceolata INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLANTAGO LANCEOLATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2216_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2216 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Plantain, English Plantago lanceolata Plantain, English Plantago lanceolata INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLANTAGO LANCEOLATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2217_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2217 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Plantain, English Plantago lanceolata Plantain, English Plantago lanceolata INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLANTAGO LANCEOLATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2251_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2251 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Privet Ligustrum vulgare Privet Ligustrum vulgare INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC LIGUSTRUM VULGARE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2252_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2252 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Privet Ligustrum vulgare Privet Ligustrum vulgare INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC LIGUSTRUM VULGARE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2293_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2293 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed, Giant Ambrosia trifida Ragweed, Giant Ambrosia trifida INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA TRIFIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2294_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2294 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed, Giant Ambrosia trifida Ragweed, Giant Ambrosia trifida INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA TRIFIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2295_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2295 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed, Giant Ambrosia trifida Ragweed, Giant Ambrosia trifida INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA TRIFIDA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2296_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2296 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed, Giant Ambrosia trifida Ragweed, Giant Ambrosia trifida INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA TRIFIDA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2297_3db2f7c5-c895-483d-ba5b-4818bc841981 65044-2297 HUMAN PRESCRIPTION DRUG Pollens - Weeds and Garden Plants, Short Ragweed, Ambrosia artemisiifolia Short Ragweed, Ambrosia artemisiifolia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19771018 BLA BLA103880 Jubilant HollisterStier LLC AMBROSIA ARTEMISIIFOLIA POLLEN .05 g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2298_3db2f7c5-c895-483d-ba5b-4818bc841981 65044-2298 HUMAN PRESCRIPTION DRUG Pollens - Weeds and Garden Plants, Short Ragweed, Ambrosia artemisiifolia Short Ragweed, Ambrosia artemisiifolia INJECTION, SOLUTION INTRADERMAL 19771018 BLA BLA103880 Jubilant HollisterStier LLC AMBROSIA ARTEMISIIFOLIA POLLEN 500 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2308_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2308 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed. Western Ambrosia psilostachya Ragweed. Western Ambrosia psilostachya INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA PSILOSTACHYA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2309_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2309 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed. Western Ambrosia psilostachya Ragweed. Western Ambrosia psilostachya INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA PSILOSTACHYA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2310_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2310 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed. Western Ambrosia psilostachya Ragweed. Western Ambrosia psilostachya INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA PSILOSTACHYA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2311_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2311 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed. Western Ambrosia psilostachya Ragweed. Western Ambrosia psilostachya INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA PSILOSTACHYA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2315_3db2f7c5-c895-483d-ba5b-4818bc841981 65044-2315 HUMAN PRESCRIPTION DRUG Pollens - Weeds and Garden Plants, Ragweed, Mixed Ambrosia Ragweed, Mixed Ambrosia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2316_3db2f7c5-c895-483d-ba5b-4818bc841981 65044-2316 HUMAN PRESCRIPTION DRUG Pollens - Weeds and Garden Plants, Ragweed, Mixed Ambrosia Ragweed, Mixed Ambrosia INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN 500; 500 [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2317_3db2f7c5-c895-483d-ba5b-4818bc841981 65044-2317 HUMAN PRESCRIPTION DRUG Pollens - Weeds and Garden Plants, Ragweed, Mixed Ambrosia Ragweed, Mixed Ambrosia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN 20000; 20000 [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2318_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2318 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Giant, Short, Western Ragweed Mix Giant, Short, Western Ragweed Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2319_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2319 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Giant, Short, Western Ragweed Mix Giant, Short, Western Ragweed Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2320_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2320 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Giant, Short, Western Ragweed Mix Giant, Short, Western Ragweed Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2359_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2359 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Russian Olive Elaeagnus angustifolia Russian Olive Elaeagnus angustifolia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ELAEAGNUS ANGUSTIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2360_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2360 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Olive, Russian Elaeagnus angustifolia Russian Olive Elaeagnus angustifolia INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ELAEAGNUS ANGUSTIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2361_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2361 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Russian Olive Elaeagnus angustifolia Russian Olive Elaeagnus angustifolia INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ELAEAGNUS ANGUSTIFOLIA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2362_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2362 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Russian Thistle Salsola kali Russian Thistle Salsola kali INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SALSOLA KALI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2363_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2363 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Russian Thistle Salsola kali Russian Thistle Salsola kali INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SALSOLA KALI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2364_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2364 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Russian Thistle Salsola kali Russian Thistle Salsola kali INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC SALSOLA KALI POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2413_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2413 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Sagebrush, Mugwort Artemisia vulgaris Sagebrush, Mugwort Artemisia vulgaris INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ARTEMISIA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2414_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2414 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Sagebrush, Mugwort Artemisia vulgaris Sagebrush, Mugwort Artemisia vulgaris INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ARTEMISIA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2415_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2415 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Sagebrush, Mugwort Artemisia vulgaris Sagebrush, Mugwort Artemisia vulgaris INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ARTEMISIA VULGARIS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2416_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2416 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Sagebrush, Mugwort Artemisia vulgaris Sagebrush, Mugwort Artemisia vulgaris INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ARTEMISIA VULGARIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2417_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2417 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Sagebrush, Mugwort Artemisia vulgaris Sagebrush, Mugwort Artemisia vulgaris INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ARTEMISIA VULGARIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2482_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2482 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Scale, Wing (Shad) Atriplex canescens Scale, Wing (Shad) Atriplex canescens INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ATRIPLEX CANESCENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2483_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2483 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Scale, Wing (Shad) Atriplex canescens Scale, Wing (Shad) Atriplex canescens INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ATRIPLEX CANESCENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2484_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2484 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Scale, Wing (Shad) Atriplex canescens Scale, Wing (Shad) Atriplex canescens INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ATRIPLEX CANESCENS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2485_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2485 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Scale, Wing (Shad) Atriplex canescens Scale, Wing (Shad) Atriplex canescens INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ATRIPLEX CANESCENS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2486_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2486 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Scotch Broom Cytisus scoparius Scotch Broom Cytisus scoparius INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CYTISUS SCOPARIUS FLOWERING TOP .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2487_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2487 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Scotch Broom Cytisus scoparius Scotch Broom Cytisus scoparius INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CYTISUS SCOPARIUS FLOWERING TOP .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2506_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2506 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Sorrel, Sheep Rumex acetosella Sorrel, Sheep Rumex acetosella INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RUMEX ACETOSELLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 65044-2507_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2507 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Sorrel, Sheep Rumex acetosella Sorrel, Sheep Rumex acetosella INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RUMEX ACETOSELLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 65044-2508_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2508 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Sorrel, Sheep Rumex acetosella Sorrel, Sheep Rumex acetosella INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RUMEX ACETOSELLA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 65044-2563_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2563 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Sycamore, American (Eastern) Platanus occidentallis Sycamore, American (Eastern) Platanus occidentallis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLATANUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2564_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2564 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Sycamore, American (Eastern) Platanus occidentallis Sycamore, American (Eastern) Platanus occidentallis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLATANUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2565_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2565 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Sycamore, American (Eastern) Platanus occidentallis Sycamore, American (Eastern) Platanus occidentallis INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLATANUS OCCIDENTALIS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2599_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2599 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree of Heaven Ailanthus altissima Tree of Heaven Ailanthus altissima INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AILANTHUS ALTISSIMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2600_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2600 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree of Heaven Ailanthus altissima Tree of Heaven Ailanthus altissima INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AILANTHUS ALTISSIMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2619_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2619 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 11 Tree Mix 11 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER SACCHARUM POLLEN; BETULA NIGRA POLLEN; CARYA OVATA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS RUBRA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN .05; .05; .05; .05; .05; .05; .05; .05; .05; .05; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2620_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2620 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 11 Tree Mix 11 INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER SACCHARUM POLLEN; BETULA NIGRA POLLEN; CARYA OVATA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS RUBRA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN .05; .05; .05; .05; .05; .05; .05; .05; .05; .05; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2621_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2621 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 11 Tree Mix 11 INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER SACCHARUM POLLEN; BETULA NIGRA POLLEN; CARYA OVATA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS RUBRA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN 500; 500; 500; 500; 500; 500; 500; 500; 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2622_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2622 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 11 Tree Mix 11 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER SACCHARUM POLLEN; BETULA NIGRA POLLEN; CARYA OVATA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS RUBRA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN .1; .1; .1; .1; .1; .1; .1; .1; .1; .1; .1 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2623_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2623 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 11 Tree Mix 11 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER SACCHARUM POLLEN; BETULA NIGRA POLLEN; CARYA OVATA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS RUBRA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN 40000; 40000; 40000; 40000; 40000; 40000; 40000; 40000; 40000; 40000; 40000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2624_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2624 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 11 Tree Mix 11 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER SACCHARUM POLLEN; BETULA NIGRA POLLEN; CARYA OVATA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS RUBRA POLLEN; SALIX NIGRA POLLEN; ULMUS AMERICANA POLLEN 20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2626_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2626 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Walnut, Black Juglans nigra Walnut, Black Juglans nigra INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2627_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2627 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Walnut, Black Juglans nigra Walnut, Black Juglans nigra INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2628_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2628 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Walnut, Black Juglans nigra Walnut, Black Juglans nigra INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUGLANS NIGRA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2629_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2629 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Walnut, Black Juglans nigra Walnut, Black Juglans nigra INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUGLANS NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2630_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2630 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Weed mix 2630 Weed mix 2630 INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS RETROFLEXUS POLLEN; CHENOPODIUM ALBUM POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; XANTHIUM STRUMARIUM POLLEN .05; .05; .025; .025; .05 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 65044-2631_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2631 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Weed mix 2630 Weed mix 2630 INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS RETROFLEXUS POLLEN; CHENOPODIUM ALBUM POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; XANTHIUM STRUMARIUM POLLEN 500; 500; 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 65044-2632_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2632 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Weed mix 2630 Weed mix 2630 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS RETROFLEXUS POLLEN; CHENOPODIUM ALBUM POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; XANTHIUM STRUMARIUM POLLEN .1; .1; .05; .05; .1 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 65044-2633_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2633 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Weed mix 2630 Weed mix 2630 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS RETROFLEXUS POLLEN; CHENOPODIUM ALBUM POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; XANTHIUM STRUMARIUM POLLEN 40000; 40000; 40000; 40000; 40000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 65044-2634_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2634 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Weed mix 2630 Weed mix 2630 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS RETROFLEXUS POLLEN; CHENOPODIUM ALBUM POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; XANTHIUM STRUMARIUM POLLEN .05; .05; .025; .025; .05 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 65044-2635_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2635 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Weed mix 2630 Weed mix 2630 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS RETROFLEXUS POLLEN; CHENOPODIUM ALBUM POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; XANTHIUM STRUMARIUM POLLEN 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] 65044-2677_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2677 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Willow, Black Salix nigra Willow, Black Salix nigra INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SALIX NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2678_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2678 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Willow, Black Salix nigra Willow, Black Salix nigra INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SALIX NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2679_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2679 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Willow, Black Salix nigra Willow, Black Salix nigra INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC SALIX NIGRA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2854_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2854 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 5 Tree Mix 5 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARUM POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; SALIX NIGRA POLLEN .017; .017; .017; .05; .05; .017; .017; .017; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2855_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2855 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 5 Tree Mix 5 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARUM POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; SALIX NIGRA POLLEN 20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2856_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2856 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 5 Tree Mix 5 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARUM POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; SALIX NIGRA POLLEN .033; .033; .033; .1; .1; .033; .033; .033; .1 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2857_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2857 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 5 Tree Mix 5 INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARUM POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; SALIX NIGRA POLLEN 500; 500; 500; 500; 500; 500; 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2858_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2858 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 5 Tree Mix 5 INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARUM POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; SALIX NIGRA POLLEN .017; .017; .017; .05; .05; .017; .017; .017; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2859_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-2859 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 6 Tree Mix 6 INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN .017; .017; .017; .05; .05; .05; .05; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2860_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-2860 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 6 Tree Mix 6 INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN 500; 500; 500; 500; 500; 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2861_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2861 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 6 Tree Mix 6 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN .033; .033; .033; .1; .1; .1; .1; .1 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2862_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2862 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 6 Tree Mix 6 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN 20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-2863_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-2863 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 6 Tree Mix 6 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN .017; .017; .017; .05; .05; .05; .05; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-3014_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3014 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Almond Prunus amygdalus Almond Prunus amygdalus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALMOND .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 65044-3015_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3015 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Almond Prunus amygdalus Almond Prunus amygdalus INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALMOND .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 65044-3020_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3020 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Apple Malus sp. Apple Malus sp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC APPLE .1 g/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] 65044-3021_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3021 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Apple Malus sp. Apple Malus sp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC APPLE .1 g/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] 65044-3041_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3041 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Banana Musa sapientum Banana Musa sapientum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BANANA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 65044-3042_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3042 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Banana Musa sapientum Banana Musa sapientum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BANANA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 65044-3074_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3074 NON-STANDARDIZED ALLERGENIC Food - Plant Source, String Bean Mix String Bean Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC STRING BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 65044-3075_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3075 NON-STANDARDIZED ALLERGENIC Food - Plant Source, String Bean Mix String Bean Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC STRING BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] 65044-3077_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3077 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Beef Bovine spp. Beef Bovine spp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BEEF .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 65044-3078_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3078 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Beef Bovine spp. Beef Bovine spp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BEEF .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 65044-3107_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3107 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Brazil Nut Bertholletia excelsa Brazil Nut Bertholletia excelsa INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BRAZIL NUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 65044-3108_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3108 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Brazil Nut Bertholletia excelsa Brazil Nut Bertholletia excelsa INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BRAZIL NUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 65044-3116_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3116 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Melon, Cantaloupe Cucumis melo Cantaloupe Cucumis melo INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANTALOUPE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 65044-3117_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3117 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Melon, Cantaloupe Cucumis melo Cantaloupe Cucumis melo INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANTALOUPE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 65044-3125_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3125 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Carrot Daucus carota Carrot Daucus carota INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARROT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 65044-3126_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3126 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Carrot Daucus carota Carrot Daucus carota INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARROT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 65044-3134_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3134 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Cashew Nut Anacardium occidentalie Cashew Nut Anacardium occidentalie INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CASHEW .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 65044-3135_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3135 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Cashew Nut Anacardium occidentalie Cashew Nut Anacardium occidentalie INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CASHEW .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 65044-3140_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3140 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Celery Apium graveolens Celery Apium graveolens INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CELERY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 65044-3141_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3141 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Celery Apium graveolens Celery Apium graveolens INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CELERY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 65044-3173_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3173 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Chicken Meat Gallus sp. Chicken Meat Gallus sp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POULTRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 65044-3174_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3174 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Chicken Meat Gallus sp. Chicken Meat Gallus sp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POULTRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] 65044-3191_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3191 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Clam Clam INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUAHOG, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 65044-3192_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3192 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Clam Clam INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUAHOG, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 65044-3203_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3203 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Codfish Gadus callarias Codfish Gadus callarias INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC COD, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 65044-3204_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3204 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Codfish Gadus callarias Codfish Gadus callarias INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC COD, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 65044-3212_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3212 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Corn Zea mays Corn Zea mays INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CORN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 65044-3213_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3213 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Corn Zea mays Corn Zea mays INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CORN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 65044-3215_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3215 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Crab Xiphosurus sowerbyi Crab Xiphosurus sowerbyi INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CRAB LEG, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 65044-3216_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3216 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Crab Xiphosurus sowerbyi Crab Xiphosurus sowerbyi INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CRAB LEG, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 65044-3248_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3248 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Egg, White Gallus sp. Egg, White Gallus sp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EGG WHITE .05 g/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 65044-3249_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3249 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Egg, White Gallus sp. Egg, White Gallus sp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EGG WHITE .05 g/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] 65044-3254_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3254 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Egg, Yolk Gallus sp. Egg, Yolk Gallus sp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EGG YOLK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] 65044-3255_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3255 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Egg, Yolk Gallus sp. Egg, Yolk Gallus sp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EGG YOLK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] 65044-3305_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3305 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Hazelnut (Filbert) Corylus spp. Hazelnut (Filbert) Corylus spp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC HAZELNUT, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 65044-3306_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3306 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Hazelnut (Filbert) Corylus spp. Hazelnut (Filbert) Corylus spp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC HAZELNUT, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 65044-3362_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3362 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Lobster Homarus americanus Lobster Homarus americanus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC LOBSTER, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 65044-3363_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3363 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Lobster Homarus americanus Lobster Homarus americanus INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC LOBSTER, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 65044-3380_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3380 NON-STANDARDIZED ALLERGENIC Food - Dairy Products, Casein, Cow Milk Casein, Cow Milk INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CASEIN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Caseins [Chemical/Ingredient] 65044-3381_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3381 NON-STANDARDIZED ALLERGENIC Food - Dairy Products, Casein, Cow Milk Casein, Cow Milk INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CASEIN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Caseins [Chemical/Ingredient] 65044-3389_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3389 NON-STANDARDIZED ALLERGENIC Food - Dairy Products, Milk, Whole Cow Milk, Whole Cow INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC COW MILK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] 65044-3390_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3390 NON-STANDARDIZED ALLERGENIC Food - Dairy Products, Milk, Whole Cow Milk, Whole Cow INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC COW MILK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] 65044-3428_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3428 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Orange Citrus sinensis Orange Citrus sinensis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ORANGE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 65044-3429_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3429 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Orange Citrus sinensis Orange Citrus sinensis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ORANGE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 65044-3449_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3449 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Pea, Green or English Pisum sativum Pea, Green or English Pisum sativum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PEA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 65044-3450_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3450 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Pea, Green or English Pisum sativum Pea, Green or English Pisum sativum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PEA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 65044-3452_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3452 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Peach Prunus persica Peach Prunus persica INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PEACH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 65044-3453_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3453 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Peach Prunus persica Peach Prunus persica INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PEACH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 65044-3455_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3455 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Peanut Arachis hypogaea Peanut Arachis hypogaea INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PEANUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 65044-3456_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3456 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Peanut Arachis hypogaea Peanut Arachis hypogaea INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PEANUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 65044-3461_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3461 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Pecan Carya illinoensis Pecan Carya illinoensis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PECAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 65044-3462_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3462 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Pecan Carya illinoensis Pecan Carya illinoensis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PECAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 65044-3509_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3509 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Pork Sus sp. Pork Sus sp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PORK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 65044-3510_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3510 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Pork Sus sp. Pork Sus sp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PORK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] 65044-3518_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3518 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Potato, White Solanum tuberosum Potato, White Solanum tuberosum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POTATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 65044-3519_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3519 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Potato, White Solanum tuberosum Potato, White Solanum tuberosum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POTATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 65044-3548_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3548 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Rice, Whole Grain Rice, Whole Grain INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RICE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 65044-3549_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3549 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Rice, Whole Grain Rice, Whole Grain INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RICE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 65044-3554_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3554 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Rye Grain Rye Grain INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RYE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 65044-3555_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3555 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Rye Grain Rye Grain INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RYE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] 65044-3564_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3564 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Salmon Salmo salar Salmon Salmo salar INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SALMON, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 65044-3565_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3565 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Salmon Salmo salar Salmon Salmo salar INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SALMON, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 65044-3584_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3584 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Shrimp Crago sp. Shrimp Crago sp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SHRIMP, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 65044-3585_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3585 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Shrimp Crago sp. Shrimp Crago sp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SHRIMP, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] 65044-3596_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3596 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Soybean Glycine soja Soybean Glycine soja INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOYBEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 65044-3597_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3597 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Soybean Glycine soja Soybean Glycine soja INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOYBEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 65044-3626_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3626 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Strawberry Fragaria chiloensis Strawberry Fragaria chiloensis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC STRAWBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 65044-3627_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3627 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Strawberry Fragaria chiloensis Strawberry Fragaria chiloensis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC STRAWBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] 65044-3656_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3656 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Tomato Nicotiana spp. Tomato Nicotiana spp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TOMATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 65044-3657_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3657 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Tomato Nicotiana spp. Tomato Nicotiana spp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TOMATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] 65044-3674_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3674 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Tuna Thunnus sp. Tuna Thunnus sp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TUNA, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 65044-3675_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3675 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Tuna Thunnus sp. Tuna Thunnus sp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TUNA, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] 65044-3695_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3695 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Walnut, Black Juglans nigra Walnut, Black Juglans nigra INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BLACK WALNUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 65044-3696_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3696 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Walnut, Black Juglans nigra Walnut, Black Juglans nigra INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BLACK WALNUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] 65044-3713_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3713 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Yeast, Baker Saccharomyces cerevisiae Yeast, Baker Saccharomyces cerevisiae INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC YEAST .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 65044-3714_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3714 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Yeast, Baker Saccharomyces cerevisiae Yeast, Baker Saccharomyces cerevisiae INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC YEAST .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 65044-3716_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-3716 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Yeast, Brewer Saccharomyces cerevisiae Yeast, Brewer Saccharomyces cerevisiae INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC YEAST .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 65044-3717_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-3717 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Yeast, Brewer Saccharomyces cerevisiae Yeast, Brewer Saccharomyces cerevisiae INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC YEAST .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] 65044-4083_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-4083 NON-STANDARDIZED ALLERGENIC Animal Allergens, Dog Hair and Dander Canis spp. Dog Hair Canis spp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANIS LUPUS FAMILIARIS DANDER; CANIS LUPUS FAMILIARIS HAIR .05; .05 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cells, Epidermal [Chemical/Ingredient] 65044-4084_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-4084 NON-STANDARDIZED ALLERGENIC Animal Allergens, Dog Hair and Dander Canis spp. Dog Hair Canis spp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANIS LUPUS FAMILIARIS DANDER; CANIS LUPUS FAMILIARIS HAIR .05; .05 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cells, Epidermal [Chemical/Ingredient] 65044-4085_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-4085 NON-STANDARDIZED ALLERGENIC Animal Allergens, Dog Hair and Dander Canis spp. Dog Hair Canis spp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANIS LUPUS FAMILIARIS DANDER; CANIS LUPUS FAMILIARIS HAIR .05; .05 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cells, Epidermal [Chemical/Ingredient] 65044-4349_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-4349 NON-STANDARDIZED ALLERGENIC Animal Allergens, Feather Mix Feather Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; GALLUS GALLUS FEATHER .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-4350_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-4350 NON-STANDARDIZED ALLERGENIC Animal Allergens, Feather Mix Feather Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; GALLUS GALLUS FEATHER .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-4351_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-4351 NON-STANDARDIZED ALLERGENIC Animal Allergens, Feather Mix Feather Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; GALLUS GALLUS FEATHER 200; 200; 200 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-4352_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-4352 NON-STANDARDIZED ALLERGENIC Animal Allergens, Feather Mix Feather Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; GALLUS GALLUS FEATHER .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-4401_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-4401 NON-STANDARDIZED ALLERGENIC Animal Allergens, Guinea Pig Hair and Dander Guinea Pig Hair and Dander INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CAVIA PORCELLUS DANDER; CAVIA PORCELLUS HAIR .05; .05 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-4402_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-4402 NON-STANDARDIZED ALLERGENIC Animal Allergens, Guinea Pig Hair and Dander Guinea Pig Hair and Dander INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CAVIA PORCELLUS DANDER; CAVIA PORCELLUS HAIR .05; .05 g/mL; g/mL Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient] 65044-4700_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-4700 NON-STANDARDIZED ALLERGENIC Dust, House Mixture Dust, House Mixture INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC HOUSE DUST .1 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 65044-4701_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-4701 NON-STANDARDIZED ALLERGENIC Dust, House Mixture Dust, House Mixture INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC HOUSE DUST .1 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 65044-4702_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-4702 NON-STANDARDIZED ALLERGENIC Dust, House Mixture Dust, House Mixture INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC HOUSE DUST 1000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 65044-4703_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-4703 NON-STANDARDIZED ALLERGENIC Dust, House Mixture Dust, House Mixture INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC HOUSE DUST 20000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 65044-4704_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-4704 NON-STANDARDIZED ALLERGENIC Dust, House Mixture Dust, House Mixture INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC HOUSE DUST 10000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 65044-4705_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-4705 NON-STANDARDIZED ALLERGENIC AP House Dust Mix AP House Dust Mix INJECTION, SOLUTION PERCUTANEOUS 19720817 BLA BLA103888 Jubilant HollisterStier LLC HOUSE DUST 20000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 65044-4706_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-4706 NON-STANDARDIZED ALLERGENIC AP House Dust Mix AP House Dust Mix INJECTION, SOLUTION INTRADERMAL 19720817 BLA BLA103888 Jubilant HollisterStier LLC HOUSE DUST 500 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 65044-4707_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-4707 NON-STANDARDIZED ALLERGENIC AP House Dust Mix AP House Dust Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720817 BLA BLA103888 Jubilant HollisterStier LLC HOUSE DUST 20000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 65044-4708_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-4708 NON-STANDARDIZED ALLERGENIC AP House Dust Mix AP House Dust Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720817 BLA BLA103888 Jubilant HollisterStier LLC HOUSE DUST 20000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] 65044-4810_a63218d1-0cde-46da-a601-7bc82f1fd921 65044-4810 HUMAN PRESCRIPTION DRUG Standardized Cat Pelt Standardized Cat Pelt INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19921020 BLA BLA103890 Jubilant HollisterStier LLC FELIS CATUS DANDER 10000 [BAU]/mL 65044-4811_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-4811 NON-STANDARDIZED ALLERGENIC Animal Allergens, AP Cattle Hair and Dander Cattle Hair and Dander INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19780130 BLA BLA103888 Jubilant HollisterStier LLC BOS TAURUS DANDER; BOS TAURUS HAIR .01; .01 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-4812_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-4812 NON-STANDARDIZED ALLERGENIC Animal Allergens, AP Cattle Hair and Dander Cattle Hair and Dander INJECTION, SOLUTION PERCUTANEOUS 19780130 BLA BLA103888 Jubilant HollisterStier LLC BOS TAURUS DANDER; BOS TAURUS HAIR .01; .01 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-4813_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-4813 NON-STANDARDIZED ALLERGENIC Animal Allergens, AP Cattle Hair and Dander Cattle Hair and Dander INJECTION, SOLUTION INTRADERMAL 19780130 BLA BLA103888 Jubilant HollisterStier LLC BOS TAURUS DANDER; BOS TAURUS HAIR .0005; .0005 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-4815_aea76a69-9a59-4043-8f43-8aea76995c5a 65044-4815 HUMAN PRESCRIPTION DRUG Standardized Cat Hair Standardized Cat Hair INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19920924 BLA BLA103889 Jubilant HollisterStier LLC FELIS CATUS HAIR 10000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] 65044-4824_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-4824 NON-STANDARDIZED ALLERGENIC Animal Allergens, AP Dog Hair and Dander Canis spp Animal Allergens, Dog Dander Canis spp INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19760824 BLA BLA103888 Jubilant HollisterStier LLC CANIS LUPUS FAMILIARIS DANDER; CANIS LUPUS FAMILIARIS HAIR .005; .005 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cells, Epidermal [Chemical/Ingredient] 65044-4825_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-4825 NON-STANDARDIZED ALLERGENIC Animal Allergens, AP Dog Hair and Dander Canis spp Animal Allergens, Dog Dander Canis spp INJECTION, SOLUTION PERCUTANEOUS 19760824 BLA BLA103888 Jubilant HollisterStier LLC CANIS LUPUS FAMILIARIS DANDER; CANIS LUPUS FAMILIARIS HAIR .005; .005 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cells, Epidermal [Chemical/Ingredient] 65044-4855_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-4855 NON-STANDARDIZED ALLERGENIC Animal Allergens, AP Horse Hair and Dander AP Horse Hair and Dander INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19780130 BLA BLA103888 Jubilant HollisterStier LLC EQUUS CABALLUS DANDER; EQUUS CABALLUS HAIR .01; .01 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-4856_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-4856 NON-STANDARDIZED ALLERGENIC Animal Allergens, AP Horse Hair and Dander AP Horse Hair and Dander INJECTION, SOLUTION PERCUTANEOUS 19780130 BLA BLA103888 Jubilant HollisterStier LLC EQUUS CABALLUS DANDER; EQUUS CABALLUS HAIR .01; .01 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-4857_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-4857 NON-STANDARDIZED ALLERGENIC Animal Allergens, AP Horse Hair and Dander AP Horse Hair and Dander INJECTION, SOLUTION INTRADERMAL 19780130 BLA BLA103888 Jubilant HollisterStier LLC EQUUS CABALLUS DANDER; EQUUS CABALLUS HAIR .0005; .0005 g/mL; g/mL Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5000_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5000 NON-STANDARDIZED ALLERGENIC Molds - Mold Mix 4 Molds - Mold Mix 4 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS TERREUS; CLADOSPORIUM CLADOSPORIOIDES; CLONOSTACHYS ROSEA F. ROSEA; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PENICILLIUM EXPANSUM .1; .025; .025; .025; .025; .1; .025; .025; .025; .025; .025 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5001_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5001 NON-STANDARDIZED ALLERGENIC Molds - Mold Mix 4 Molds - Mold Mix 4 INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS TERREUS; CLADOSPORIUM CLADOSPORIOIDES; CLONOSTACHYS ROSEA F. ROSEA; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PENICILLIUM EXPANSUM 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5002_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5002 NON-STANDARDIZED ALLERGENIC Molds - Mold Mix 4 Molds - Mold Mix 4 INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS TERREUS; CLADOSPORIUM CLADOSPORIOIDES; CLONOSTACHYS ROSEA F. ROSEA; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM .1; .025; .025; .025; .025; .1; .025; .025; .025; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5003_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5003 NON-STANDARDIZED ALLERGENIC Molds - Alternaria/Hormodendrum Mix Molds - Alternaria/Hormodendrum Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA; CLADOSPORIUM CLADOSPORIOIDES .1; .1 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5004_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5004 NON-STANDARDIZED ALLERGENIC Molds - Alternaria/Hormodendrum Mix Molds - Alternaria/Hormodendrum Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA; CLADOSPORIUM CLADOSPORIOIDES .1; .1 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5008_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5008 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Alternaria tenuis Alternaria tenuis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5009_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5009 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Alternaria tenuis Alternaria tenuis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5010_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5010 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Alternaria tenuis Alternaria tenuis INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5020_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5020 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ASPERGILLUS FUMIGATUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5021_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5021 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ASPERGILLUS FUMIGATUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5022_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5022 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ASPERGILLUS FUMIGATUS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5032_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5032 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Aspergillus niger Aspergillus niger INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ASPERGILLUS NIGER VAR. NIGER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5033_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5033 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Aspergillus niger Aspergillus niger INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ASPERGILLUS NIGER VAR. NIGER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5048_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5048 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BOTRYTIS CINEREA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5049_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5049 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BOTRYTIS CINEREA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5052_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5052 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Candida albicans Candida albicans INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANDIDA ALBICANS .1 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 65044-5053_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5053 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Candida albicans Candida albicans INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANDIDA ALBICANS .1 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 65044-5054_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5054 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANDIDA ALBICANS 1000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 65044-5055_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5055 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Candida albicans Candida albicans INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANDIDA ALBICANS .001 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] 65044-5056_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5056 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Cephalosporium acremonium Cephalosporium acremonium INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACREMONIUM STRICTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5057_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5057 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Cephalosporium acremonium Cephalosporium acremonium INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACREMONIUM STRICTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5058_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5058 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Cephalosporium acremonium Cephalosporium acremonium INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACREMONIUM STRICTUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5076_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5076 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Curvularia spicifera Curvularia spicifera INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC COCHLIOBOLUS SPICIFER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5077_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5077 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Curvularia spicifera Curvularia spicifera INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC COCHLIOBOLUS SPICIFER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5078_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5078 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Curvularia spicifera Curvularia spicifera INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC COCHLIOBOLUS SPICIFER 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5100_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5100 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EPICOCCUM NIGRUM .1 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 65044-5101_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5101 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EPICOCCUM NIGRUM .1 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 65044-5102_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5102 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC EPICOCCUM NIGRUM 1000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] 65044-5104_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5104 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Epidermophyton floccosum Epidermophyton floccosum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EPIDERMOPHYTON FLOCCOSUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5105_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5105 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Epidermophyton floccosum Epidermophyton floccosum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EPIDERMOPHYTON FLOCCOSUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5112_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5112 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Fusarium vasinfectum Fusarium vasinfectum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FUSARIUM OXYSPORUM VASINFECTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5113_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5113 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Fusarium vasinfectum Fusarium vasinfectum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FUSARIUM OXYSPORUM VASINFECTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5114_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5114 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Fusarium vasinfectum Fusarium vasinfectum INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC FUSARIUM OXYSPORUM VASINFECTUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5124_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5124 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Helminthosporium interseminatum Helminthosporium interseminatum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC DENDRYPHIELLA VINOSA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5125_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5125 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Helminthosporium interseminatum Helminthosporium interseminatum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC DENDRYPHIELLA VINOSA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5126_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5126 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Helminthosporium interseminatum Helminthosporium interseminatum INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC DENDRYPHIELLA VINOSA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5128_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5128 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Hormodendrum cladosporioides Hormodendrum cladosporioides INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CLADOSPORIUM CLADOSPORIOIDES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5129_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5129 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Hormodendrum cladosporioides Hormodendrum cladosporioides INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CLADOSPORIUM CLADOSPORIOIDES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5130_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5130 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Hormodendrum cladosporioides Hormodendrum cladosporioides INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC CLADOSPORIUM CLADOSPORIOIDES 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5136_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5136 NON-STANDARDIZED ALLERGENIC Molds - Mold Mix 10 Molds - Mold Mix 10 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS TERREUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CLADOSPORIUM CLADOSPORIOIDES; CLONOSTACHYS ROSEA F. ROSEA; DENDRYPHIELLA VINOSA; FUSARIUM OXYSPORUM VASINFECTUM; MUCOR RACEMOSUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PENICILLIUM EXPANSUM; PHOMA EXIGUA VAR. EXIGUA; RHIZOPUS STOLONIFER .1; .025; .025; .025; .025; .1; .1; .02; .1; .1; .1; .02; .02; .02; .02; .1; .1 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5137_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5137 NON-STANDARDIZED ALLERGENIC Molds - Mold Mix 10 Molds - Mold Mix 10 INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS TERREUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CLADOSPORIUM CLADOSPORIOIDES; CLONOSTACHYS ROSEA F. ROSEA; DENDRYPHIELLA VINOSA; FUSARIUM OXYSPORUM VASINFECTUM; MUCOR RACEMOSUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PHOMA EXIGUA VAR. EXIGUA; RHIZOPUS STOLONIFER .1; .025; .025; .025; .025; .1; .1; .02; .1; .1; .1; .02; .02; .04; .1; .1 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5138_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5138 NON-STANDARDIZED ALLERGENIC Molds - Mold Mix 10 Molds - Mold Mix 10 INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS TERREUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CLADOSPORIUM CLADOSPORIOIDES; CLONOSTACHYS ROSEA F. ROSEA; DENDRYPHIELLA VINOSA; FUSARIUM OXYSPORUM VASINFECTUM; MUCOR RACEMOSUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PENICILLIUM EXPANSUM; PHOMA EXIGUA VAR. EXIGUA; RHIZOPUS STOLONIFER 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5144_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5144 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Mucor racemosus Mucor racemosus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC MUCOR RACEMOSUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5145_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5145 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Mucor racemosus Mucor racemosus INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC MUCOR RACEMOSUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5146_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5146 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Mucor racemosus Mucor racemosus INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC MUCOR RACEMOSUS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5168_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5168 NON-STANDARDIZED ALLERGENIC Molds, Penicillium Mix Molds, Penicillium Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CLONOSTACHYS ROSEA F. ROSEA; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PENICILLIUM EXPANSUM .1; .1; .1; .1; .1 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5169_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5169 NON-STANDARDIZED ALLERGENIC Molds, Penicillium Mix Molds, Penicillium Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CLONOSTACHYS ROSEA F. ROSEA; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM .1; .1; .1; .2 g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5170_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5170 NON-STANDARDIZED ALLERGENIC Molds, Penicillium Mix Molds, Penicillium Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC CLONOSTACHYS ROSEA F. ROSEA; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PENICILLIUM EXPANSUM 1000; 1000; 1000; 1000; 1000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5208_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5208 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Penicillium notatum Penicillium notatum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5209_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5209 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Penicillium notatum Penicillium notatum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5210_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5210 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5220_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5220 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Phoma herbarum Phoma herbarum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PHOMA EXIGUA VAR. EXIGUA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5221_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5221 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Phoma herbarum Phoma herbarum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PHOMA EXIGUA VAR. EXIGUA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5222_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5222 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Phoma herbarum Phoma herbarum INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC PHOMA EXIGUA VAR. EXIGUA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5230_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5230 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Rhizopus nigricans Rhizopus nigricans INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RHIZOPUS STOLONIFER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5231_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5231 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Rhizopus nigricans Rhizopus nigricans INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC RHIZOPUS STOLONIFER 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5232_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5232 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Rhizopus nigricans Rhizopus nigricans INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RHIZOPUS STOLONIFER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5233_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5233 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Pullularia pullulans Pullularia pullulans INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AUREOBASIDIUM PULLULANS VAR. PULLUTANS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5234_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5234 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Pullularia pullulans Pullularia pullulans INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC AUREOBASIDIUM PULLULANS VAR. PULLUTANS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5235_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5235 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Pullularia pullulans Pullularia pullulans INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AUREOBASIDIUM PULLULANS VAR. PULLUTANS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5264_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5264 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Stemphylium botryosum Stemphylium botryosum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLEOSPORA TARDA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5265_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5265 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Stemphylium botryosum Stemphylium botryosum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLEOSPORA TARDA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5266_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5266 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Stemphylium botryosum Stemphylium botryosum INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLEOSPORA TARDA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5284_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-5284 NON-STANDARDIZED ALLERGENIC Molds - Trichophyton Mix Molds - Trichophyton Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TRICHOPHYTON MENTAGROPHYTES; TRICHOPHYTON RUBRUM; TRICHOPHYTON TONSURANS .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5285_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-5285 NON-STANDARDIZED ALLERGENIC Molds - Trichophyton Mix Molds - Trichophyton Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TRICHOPHYTON MENTAGROPHYTES; TRICHOPHYTON RUBRUM; TRICHOPHYTON TONSURANS .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-5286_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-5286 NON-STANDARDIZED ALLERGENIC Molds - Trichophyton Mix Molds - Trichophyton Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC TRICHOPHYTON MENTAGROPHYTES; TRICHOPHYTON RUBRUM; TRICHOPHYTON TONSURANS 1000; 1000; 1000 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6513_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-6513 NON-STANDARDIZED ALLERGENIC Insects (Whole Body), Ant, Fire Solenopsis Invicta Ant, Fire Solenopsis Invicta INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLENOPSIS INVICTA .1 g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6514_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-6514 NON-STANDARDIZED ALLERGENIC Insects (Whole Body), Ant, Fire Solenopsis richteri Ant, Fire Solenopsis richteri INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLENOPSIS RICHTERI .1 g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6515_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-6515 NON-STANDARDIZED ALLERGENIC Insects (whole body), Fire Ant Mix Insects (whole body), Fire Ant Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLENOPSIS INVICTA; SOLENOPSIS RICHTERI .1; .1 g/mL; g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6516_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-6516 NON-STANDARDIZED ALLERGENIC Insects (whole body), Fire Ant Mix Insects (whole body), Fire Ant Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLENOPSIS INVICTA; SOLENOPSIS RICHTERI 500; 500 [PNU]/mL; [PNU]/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6517_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-6517 NON-STANDARDIZED ALLERGENIC Insects (whole body), Fire Ant Mix Insects (whole body), Fire Ant Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLENOPSIS INVICTA; SOLENOPSIS RICHTERI .1; .1 g/mL; g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6518_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-6518 NON-STANDARDIZED ALLERGENIC Insects (whole body), Fire Ant Mix Insects (whole body), Fire Ant Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLENOPSIS INVICTA; SOLENOPSIS RICHTERI .1; .1 g/mL; g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6580_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-6580 NON-STANDARDIZED ALLERGENIC Insects (whole body) cockroach, American Periplaneta americana Insects (whole body) cockroach, American Periplaneta americana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PERIPLANETA AMERICANA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6581_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-6581 NON-STANDARDIZED ALLERGENIC Insects (whole body) Cockroach, German Blatella germanica Insects (whole body) Cockroach, German Blatella germanica INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BLATELLA GERMANICA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6584_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-6584 NON-STANDARDIZED ALLERGENIC Insects (whole body) cockroach mix Insects (whole body) cockroach mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BLATELLA GERMANICA; PERIPLANETA AMERICANA .1; .1 g/mL; g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6585_4932ccd6-3478-4f65-a8cc-df4d927df2d3 65044-6585 NON-STANDARDIZED ALLERGENIC Insects (whole body) cockroach mix Insects (whole body) cockroach mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BLATELLA GERMANICA; PERIPLANETA AMERICANA .1; .1 g/mL; g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6586_cfb9e75e-de4a-477d-b567-20fb5caf585b 65044-6586 NON-STANDARDIZED ALLERGENIC Insects (whole body) cockroach mix Insects (whole body) cockroach mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC BLATELLA GERMANICA; PERIPLANETA AMERICANA 500; 500 [PNU]/mL; [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6587_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-6587 NON-STANDARDIZED ALLERGENIC Insects (whole body) cockroach mix Insects (whole body) cockroach mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BLATELLA GERMANICA; PERIPLANETA AMERICANA .1; .1 g/mL; g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6588_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-6588 NON-STANDARDIZED ALLERGENIC Insects (whole body) cockroach mix Insects (whole body) cockroach mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BLATELLA GERMANICA; PERIPLANETA AMERICANA 20000; 20000 [PNU]/mL; [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6589_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-6589 NON-STANDARDIZED ALLERGENIC Insects (whole body) cockroach mix Insects (whole body) cockroach mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BLATELLA GERMANICA; PERIPLANETA AMERICANA 20000; 20000 [PNU]/mL; [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6590_9a866e1c-0fcc-41fc-bd5f-26489f0a0124 65044-6590 NON-STANDARDIZED ALLERGENIC Insects (whole body) cockroach mix Insects (whole body) cockroach mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BLATELLA GERMANICA; PERIPLANETA AMERICANA 5000; 5000 [PNU]/mL; [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6690_aaff316d-6100-41eb-afe4-9538cb897e43 65044-6690 HUMAN PRESCRIPTION DRUG Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 30000 AU per mL Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 30000 AU per mL INJECTION, SOLUTION SUBCUTANEOUS 19880526 BLA BLA103870 Jubilant HollisterStier LLC DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 15000; 15000 [AU]/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6691_aaff316d-6100-41eb-afe4-9538cb897e43 65044-6691 HUMAN PRESCRIPTION DRUG Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL INJECTION, SOLUTION SUBCUTANEOUS 19880526 BLA BLA103870 Jubilant HollisterStier LLC DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 5000; 5000 [AU]/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6692_aaff316d-6100-41eb-afe4-9538cb897e43 65044-6692 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides pteronyssinus, Scratch or Bulk, 30000 AU per mL Standardized Mite, Dermatophagoides pteronyssinus, Scratch or Bulk, 30000 AU per mL INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19880526 BLA BLA103871 Jubilant HollisterStier LLC DERMATOPHAGOIDES PTERONYSSINUS 30000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6693_aaff316d-6100-41eb-afe4-9538cb897e43 65044-6693 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 30 AU per mL Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 30 AU per mL INJECTION, SOLUTION INTRADERMAL 19880526 BLA BLA103871 Jubilant HollisterStier LLC DERMATOPHAGOIDES PTERONYSSINUS 30 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6694_aaff316d-6100-41eb-afe4-9538cb897e43 65044-6694 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 300 AU per mL Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 300 AU per mL INJECTION, SOLUTION INTRADERMAL 19880526 BLA BLA103871 Jubilant HollisterStier LLC DERMATOPHAGOIDES PTERONYSSINUS 300 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6695_aaff316d-6100-41eb-afe4-9538cb897e43 65044-6695 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides pteronyssinus, Bulk, 10000 AU per mL Standardized Mite, Dermatophagoides pteronyssinus, Bulk, 10000 AU per mL INJECTION, SOLUTION SUBCUTANEOUS 19880526 BLA BLA103871 Jubilant HollisterStier LLC DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6720_aaff316d-6100-41eb-afe4-9538cb897e43 65044-6720 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides farinae, Scratch or Bulk, 30000 AU per mL Standardized Mite, Dermatophagoides farinae, Scratch or Bulk, 30000 AU per mL INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19880526 BLA BLA103870 Jubilant HollisterStier LLC DERMATOPHAGOIDES FARINAE 30000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6721_aaff316d-6100-41eb-afe4-9538cb897e43 65044-6721 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides farinae, Intradermal, 30 AU per mL Standardized Mite, Dermatophagoides farinae, Intradermal, 30 AU per mL INJECTION, SOLUTION INTRADERMAL 19880526 BLA BLA103870 Jubilant HollisterStier LLC DERMATOPHAGOIDES FARINAE 30 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6722_aaff316d-6100-41eb-afe4-9538cb897e43 65044-6722 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides farinae, Intradermal, 300 AU per mL Standardized Mite, Dermatophagoides farinae, Intradermal, 300 AU per mL INJECTION, SOLUTION INTRADERMAL 19880526 BLA BLA103870 Jubilant HollisterStier LLC DERMATOPHAGOIDES FARINAE 300 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-6723_aaff316d-6100-41eb-afe4-9538cb897e43 65044-6723 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides farinae, Bulk, 10000 AU per mL Standardized Mite, Dermatophagoides farinae, Bulk, 10000 AU per mL INJECTION, SOLUTION SUBCUTANEOUS 19880526 BLA BLA103870 Jubilant HollisterStier LLC DERMATOPHAGOIDES FARINAE 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-9940_50064ddf-39b6-49c8-b12d-9320c8bd0a50 65044-9940 HUMAN PRESCRIPTION DRUG Honey Bee hymenoptera venom Multidose Honey Bee hymenoptera venom Multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19791016 BLA BLA103882 Jubilant HollisterStier LLC APIS MELLIFERA VENOM 100 ug/mL 65044-9941_50064ddf-39b6-49c8-b12d-9320c8bd0a50 65044-9941 HUMAN PRESCRIPTION DRUG White Faced Hornet Hymenoptera Venom Multidose White Faced Hornet Hymenoptera Venom Multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19791016 BLA BLA103885 Jubilant HollisterStier LLC DOLICHOVESPULA MACULATA VENOM PROTEIN 100 ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-9942_50064ddf-39b6-49c8-b12d-9320c8bd0a50 65044-9942 HUMAN PRESCRIPTION DRUG Yellow Hornet hymenoptera venom Multidose Yellow Hornet hymenoptera venom Multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19791016 BLA BLA103886 Jubilant HollisterStier LLC DOLICHOVESPULA ARENARIA VENOM PROTEIN 100 ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-9943_50064ddf-39b6-49c8-b12d-9320c8bd0a50 65044-9943 HUMAN PRESCRIPTION DRUG Wasp hymenoptera venom Multidose Wasp hymenoptera venom Multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19791016 BLA BLA103884 Jubilant HollisterStier LLC POLISTES ANNULARIS VENOM PROTEIN; POLISTES EXCLAMANS VENOM PROTEIN; POLISTES FUSCATUS VENOM PROTEIN; POLISTES METRICUS VENOM PROTEIN 25; 25; 25; 25 ug/mL; ug/mL; ug/mL; ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-9944_50064ddf-39b6-49c8-b12d-9320c8bd0a50 65044-9944 HUMAN PRESCRIPTION DRUG Yellow Jacket hymenoptera venom Multidose Yellow Jacket hymenoptera venom Multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19791016 BLA BLA103887 Jubilant HollisterStier LLC VESPULA GERMANICA VENOM PROTEIN; VESPULA MACULIFRONS VENOM PROTEIN; VESPULA PENSYLVANICA VENOM PROTEIN; VESPULA SQUAMOSA VENOM PROTEIN; VESPULA VULGARIS VENOM PROTEIN 20; 20; 20; 20; 20 ug/mL; ug/mL; ug/mL; ug/mL; ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-9945_50064ddf-39b6-49c8-b12d-9320c8bd0a50 65044-9945 HUMAN PRESCRIPTION DRUG Mixed Vespid Hymenoptera Venom Multidose Mixed Vespid Hymenoptera Venom Multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 19801211 BLA BLA103883 Jubilant HollisterStier LLC DOLICHOVESPULA ARENARIA VENOM PROTEIN; DOLICHOVESPULA MACULATA VENOM PROTEIN; VESPULA GERMANICA VENOM PROTEIN; VESPULA MACULIFRONS VENOM PROTEIN; VESPULA PENSYLVANICA VENOM PROTEIN; VESPULA SQUAMOSA VENOM PROTEIN; VESPULA VULGARIS VENOM PROTEIN 100; 100; 20; 20; 20; 20; 20 ug/mL; ug/mL; ug/mL; ug/mL; ug/mL; ug/mL; ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-9950_3b0905c0-61d3-4083-84f0-bba1109a9c46 65044-9950 HUMAN PRESCRIPTION DRUG honey bee hymenoptera venom multidose honey bee hymenoptera venom multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19950411 BLA BLA103882 Jubilant HollisterStier LLC APIS MELLIFERA VENOM 100 ug/mL 65044-9951_3b0905c0-61d3-4083-84f0-bba1109a9c46 65044-9951 HUMAN PRESCRIPTION DRUG white faced hornet hymenoptera venom multidose white faced hornet hymenoptera venom multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19950411 BLA BLA103885 Jubilant HollisterStier LLC DOLICHOVESPULA MACULATA VENOM PROTEIN 100 ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-9953_3b0905c0-61d3-4083-84f0-bba1109a9c46 65044-9953 HUMAN PRESCRIPTION DRUG wasp hymenoptera venom multidose wasp hymenoptera venom multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19950411 BLA BLA103884 Jubilant HollisterStier LLC POLISTES ANNULARIS VENOM PROTEIN; POLISTES EXCLAMANS VENOM PROTEIN; POLISTES FUSCATUS VENOM PROTEIN; POLISTES METRICUS VENOM PROTEIN 25; 25; 25; 25 ug/mL; ug/mL; ug/mL; ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-9954_3b0905c0-61d3-4083-84f0-bba1109a9c46 65044-9954 HUMAN PRESCRIPTION DRUG yellow jacket hymenoptera venom multidose yellow jacket hymenoptera venom multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19950411 BLA BLA103887 Jubilant HollisterStier LLC VESPULA GERMANICA VENOM PROTEIN; VESPULA MACULIFRONS VENOM PROTEIN; VESPULA PENSYLVANICA VENOM PROTEIN; VESPULA SQUAMOSA VENOM PROTEIN; VESPULA VULGARIS VENOM PROTEIN 20; 20; 20; 20; 20 ug/mL; ug/mL; ug/mL; ug/mL; ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-9955_3b0905c0-61d3-4083-84f0-bba1109a9c46 65044-9955 HUMAN PRESCRIPTION DRUG mixed vespid hymenoptera venom multidose mixed vespid hymenoptera venom multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 19950411 BLA BLA103883 Jubilant HollisterStier LLC DOLICHOVESPULA ARENARIA VENOM PROTEIN; DOLICHOVESPULA MACULATA VENOM PROTEIN; VESPULA GERMANICA VENOM PROTEIN; VESPULA MACULIFRONS VENOM PROTEIN; VESPULA PENSYLVANICA VENOM PROTEIN; VESPULA SQUAMOSA VENOM PROTEIN; VESPULA VULGARIS VENOM PROTEIN 100; 100; 20; 20; 20; 20; 20 ug/mL; ug/mL; ug/mL; ug/mL; ug/mL; ug/mL; ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] 65044-9960_e492b8fa-1fe8-4ff9-858d-089471feb216 65044-9960 HUMAN PRESCRIPTION DRUG Honey Bee hymenoptera venom Venomil Diagnostic Honey Bee hymenoptera venom Venomil Diagnostic KIT PERCUTANEOUS 19820222 BLA BLA103882 Jubilant HollisterStier LLC 65044-9961_e492b8fa-1fe8-4ff9-858d-089471feb216 65044-9961 HUMAN PRESCRIPTION DRUG White Faced Hornet hymenoptera venom Venomil Diagnostic White Faced Hornet hymenoptera venom Venomil Diagnostic KIT PERCUTANEOUS 19820222 BLA BLA103885 Jubilant HollisterStier LLC 65044-9962_e492b8fa-1fe8-4ff9-858d-089471feb216 65044-9962 HUMAN PRESCRIPTION DRUG Yellow Hornet hymenoptera venom Venomil Diagnostic Yellow Hornet hymenoptera venom Venomil Diagnostic KIT PERCUTANEOUS 19820222 BLA BLA103886 Jubilant HollisterStier LLC 65044-9963_e492b8fa-1fe8-4ff9-858d-089471feb216 65044-9963 HUMAN PRESCRIPTION DRUG Wasp hymenoptera venom Venomil Diagnostic Wasp hymenoptera venom Venomil Diagnostic KIT PERCUTANEOUS 19820222 BLA BLA103884 Jubilant HollisterStier LLC 65044-9964_e492b8fa-1fe8-4ff9-858d-089471feb216 65044-9964 HUMAN PRESCRIPTION DRUG Yellow Jacket hymenoptera venom Venomil Diagnostic Yellow Jacket hymenoptera venom Venomil Diagnostic KIT PERCUTANEOUS 19820222 BLA BLA103887 Jubilant HollisterStier LLC 65044-9970_e492b8fa-1fe8-4ff9-858d-089471feb216 65044-9970 HUMAN PRESCRIPTION DRUG Honey Bee hymenoptera venom Venomil Maintenance Honey Bee hymenoptera venom Venomil Maintenance KIT SUBCUTANEOUS 19820222 BLA BLA103882 Jubilant HollisterStier LLC 65044-9971_e492b8fa-1fe8-4ff9-858d-089471feb216 65044-9971 HUMAN PRESCRIPTION DRUG White Faced Hornet hymenoptera venom Venomil Maintenance White Faced Hornet hymenoptera venom Venomil Maintenance KIT SUBCUTANEOUS 19820222 BLA BLA103885 Jubilant HollisterStier LLC 65044-9972_e492b8fa-1fe8-4ff9-858d-089471feb216 65044-9972 HUMAN PRESCRIPTION DRUG Yellow Hornet hymenoptera venom Venomil Maintenance Yellow Hornet hymenoptera venom Venomil Maintenance KIT SUBCUTANEOUS 19820222 BLA BLA103886 Jubilant HollisterStier LLC 65044-9973_e492b8fa-1fe8-4ff9-858d-089471feb216 65044-9973 HUMAN PRESCRIPTION DRUG Wasp hymenoptera venom Venomil Maintenance Wasp hymenoptera venom Venomil Maintenance KIT SUBCUTANEOUS 19820222 BLA BLA103884 Jubilant HollisterStier LLC 65044-9974_e492b8fa-1fe8-4ff9-858d-089471feb216 65044-9974 HUMAN PRESCRIPTION DRUG Yellow Jacket hymenoptera venom Venomil Maintenance Yellow Jacket hymenoptera venom Venomil Maintenance KIT SUBCUTANEOUS 19820222 BLA BLA103887 Jubilant HollisterStier LLC 65044-9975_e492b8fa-1fe8-4ff9-858d-089471feb216 65044-9975 HUMAN PRESCRIPTION DRUG Mixed Vespid hymenoptera venom Venomil Maintenance Mixed Vespid hymenoptera venom Venomil Maintenance KIT SUBCUTANEOUS 19820222 BLA BLA103883 Jubilant HollisterStier LLC 65044-9990_673b931b-9404-4888-bd30-fb6b18a66ea9 65044-9990 HUMAN PRESCRIPTION DRUG Diluent for Allergenic Extract - Sterile Normal Saline with Phenol Normal Saline with Phenol INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19790801 BLA BLA103888 Hollister-Stier Laboratories LLC 65044-9991_673b931b-9404-4888-bd30-fb6b18a66ea9 65044-9991 HUMAN PRESCRIPTION DRUG Diluent for Allergenic Extract - Sterile Normal Saline with Phenol Normal Saline with Phenol INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19790801 BLA BLA103888 Hollister-Stier Laboratories LLC 65044-9992_885ee89c-5dff-4b30-b950-66eb6fe426de 65044-9992 HUMAN PRESCRIPTION DRUG Diluent for Allergenic Extract - Sterile Buffered Saline with Phenol Buffered Saline with Phenol INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19790801 BLA BLA103888 Hollister-Stier Laboratories LLC 65044-9993_705e463b-0088-4028-9033-0dde85cfc6cb 65044-9993 HUMAN PRESCRIPTION DRUG Diluent for Allergenic Extract - Sterile Albumin Saline with Phenol Albumin Saline with Phenol INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19790801 BLA BLA103888 Hollister-Stier Laboratories LLC 65044-9996_705e463b-0088-4028-9033-0dde85cfc6cb 65044-9996 HUMAN PRESCRIPTION DRUG Diluent for Allergenic Extract - Sterile Albumin Saline with Phenol Albumin Saline with Phenol INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19790801 BLA BLA103888 Hollister-Stier Laboratories LLC 65044-9998_38f02b2f-0d35-43dc-8b2e-826e080145c9 65044-9998 HUMAN PRESCRIPTION DRUG Positive Skin Test Control - Histamine Histamine INJECTION PERCUTANEOUS 19950615 BLA BLA103891 Jubilant HollisterStier LLC HISTAMINE 6 mg/mL 65055-101_8e372e7a-82dc-486c-b1b0-04f40dd2ed5e 65055-101 HUMAN OTC DRUG Iodine Tincture Iodine Tincture TINCTURE TOPICAL 20130927 OTC MONOGRAPH NOT FINAL part333A Laboratorios Jaloma, S.A. de C.V. IODINE; SODIUM IODIDE 2; 2.4 g/100mL; g/100mL 65055-201_86f0d4db-5625-4ec4-b5b2-811475ffac81 65055-201 HUMAN OTC DRUG Mertodol Solution BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130925 OTC MONOGRAPH NOT FINAL part333A Laboratorios Jaloma, S.A. de C.V. BENZALKONIUM CHLORIDE .13 g/100mL 65055-301_9350d535-6e55-4bcc-8bfa-4e2c26bd0efb 65055-301 HUMAN OTC DRUG White Mertodol Benzalkonium Chloride LIQUID TOPICAL 20130925 OTC MONOGRAPH NOT FINAL part333A Laboratorios Jaloma, S.A. de C.V. BENZALKONIUM CHLORIDE .13 g/100mL 65055-401_3e1717af-cb87-4e61-8ef9-345e2a58d458 65055-401 HUMAN OTC DRUG Gentian Violet Topical Solution Gentian Violet LIQUID TOPICAL 20130927 OTC MONOGRAPH NOT FINAL part333A Laboratorios Jaloma, S.A. de C.V. GENTIAN VIOLET 1 g/100mL 65055-501_646dccb8-6393-4bf8-903e-5474f622a203 65055-501 HUMAN OTC DRUG Hydrogen Peroxide Solution Hydrogen Peroxide LIQUID TOPICAL 20130918 OTC MONOGRAPH NOT FINAL part333A Laboratorios Jaloma, S.A. de C.V. HYDROGEN PEROXIDE 3 mL/100mL 65055-601_fe035e9f-e8da-467a-862d-49fc265cf4bc 65055-601 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20130927 OTC MONOGRAPH NOT FINAL part333A Laboratorios Jaloma, S.A. de C.V. ISOPROPYL ALCOHOL 70 mL/100mL 65055-701_ceab72e6-5332-4d57-ad6d-aac45ec33fb4 65055-701 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part333 Laboratorios Jaloma, S.A. de C.V. ALCOHOL 64 g/100mL 65067-321_647ae7ea-c9f1-4d66-bb56-195ba3e52928 65067-321 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20020101 UNAPPROVED MEDICAL GAS Hampton Homecare OXYGEN 99 L/100L 65076-0001_9643b457-b528-4dc1-bb0d-573552299660 65076-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20081001 UNAPPROVED MEDICAL GAS Advanced Health Services, Inc. OXYGEN 99 L/100L 65076-101_8372edcf-62dc-4fe6-90d5-be8422ab92b0 65076-101 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19990101 UNAPPROVED MEDICAL GAS Bickett Machine and Supply, Inc OXYGEN 99 L/100L 65084-123_0f4e771f-b317-4220-8391-dfcfb83bd479 65084-123 HUMAN PRESCRIPTION DRUG Donnatal PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE TABLET ORAL 20140526 UNAPPROVED DRUG OTHER RxPak Division of McKesson Corporation ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 65084-266_604bbd25-33d0-4f90-b304-ed80702c3c37 65084-266 HUMAN PRESCRIPTION DRUG Lorcet 10/650 hydrocodone bitartrate, acetaminophen TABLET ORAL 20011221 ANDA ANDA081223 Rx Pak Division of McKesson Corporation ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 65084-267_f8399d7a-7e4c-4f2c-ae7f-60ef0ae0c7f4 65084-267 HUMAN PRESCRIPTION DRUG Lorcet Plus hydrocodone bitartrate, acetaminophen TABLET ORAL 20011221 ANDA ANDA089689 Rx Pak Division of McKesson Corporation ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 65084-283_3577d0de-010b-4266-9b6f-806bbddbbde9 65084-283 HUMAN PRESCRIPTION DRUG Lortab hydrocodone bitartrate, acetaminophen TABLET ORAL 20020228 ANDA ANDA089699 Rx Pak Division of McKesson Corporation ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 65084-285_a11c2438-769f-4ddc-85f4-fcd4b3755465 65084-285 HUMAN PRESCRIPTION DRUG Lortab hydrocodone bitartrate, acetaminophen TABLET ORAL 20020228 ANDA ANDA040100 Rx Pak Division of McKesson Corporation ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 65084-287_6e48680d-b4ea-4eca-86ab-d9eb3434855b 65084-287 HUMAN PRESCRIPTION DRUG Lortab hydrocodone bitartrate and acetaminophen TABLET ORAL 20020228 ANDA ANDA087722 Rx Pak Division of McKesson Corporation ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 65084-298_66a32123-df98-43fe-8c8a-e153bc3b0c07 65084-298 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride, acetaminophen TABLET ORAL 20020430 ANDA ANDA040330 Rx Pak Division of McKesson Corporation ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 65084-441_d569d038-57b7-4010-8678-8f0c762b5739 65084-441 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20091009 ANDA ANDA078203 Rx Pak Division of McKesson Corporation LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65084-442_d569d038-57b7-4010-8678-8f0c762b5739 65084-442 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20091009 ANDA ANDA078203 Rx Pak Division of McKesson Corporation LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65084-443_d569d038-57b7-4010-8678-8f0c762b5739 65084-443 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20091009 ANDA ANDA078203 Rx Pak Division of McKesson Corporation LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65084-444_d980c37d-2d96-4477-a1ab-ca069c761683 65084-444 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100913 ANDA ANDA089160 Rx Pak Division of McKesson Corporation ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 65084-453_d08cc0ab-4cb5-4290-8d46-5d8b66e8472e 65084-453 HUMAN PRESCRIPTION DRUG Hydrocodone Bitatrate and Acetaminophen Hydrocodone Bitatrate and Acetaminophen TABLET ORAL 20130624 ANDA ANDA040148 Rx Pak Division of McKesson Corporation ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 65084-454_5d248332-87ff-45c2-be92-e9e8386a4749 65084-454 HUMAN PRESCRIPTION DRUG Fioricet Butalbital, Acetaminophen, and Caffeine CAPSULE ORAL 20130729 ANDA ANDA040885 Rx Pak Division of McKesson Corporation ACETAMINOPHEN; BUTALBITAL; CAFFEINE 300; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 65084-455_bc38a536-b8e0-4b1b-ba20-4bf6e59e4e35 65084-455 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 19840914 NDA NDA020405 Rx Pak Division of McKesson Corporation DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 65084-456_a13a7632-74ea-4e2f-b791-190a4765c295 65084-456 HUMAN PRESCRIPTION DRUG Pacerone Amiodarone Hydrochloride TABLET ORAL 20140428 ANDA ANDA075135 RxPak Division of McKesson Corporation AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 65084-457_d317020c-0850-4a5b-b344-74ad10b0b089 65084-457 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20140516 NDA NDA021035 RxPak Division of McKesson Corporation LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65084-458_d317020c-0850-4a5b-b344-74ad10b0b089 65084-458 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20140516 NDA NDA021035 RxPak Division of McKesson Corporation LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65084-459_d317020c-0850-4a5b-b344-74ad10b0b089 65084-459 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20140516 NDA NDA021035 RxPak Division of McKesson Corporation LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65084-460_750462e4-0053-496b-8692-cf9132482ed9 65084-460 HUMAN PRESCRIPTION DRUG Keppra XR levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140516 NDA NDA022285 RxPak Division of McKesson Corporation LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65084-461_750462e4-0053-496b-8692-cf9132482ed9 65084-461 HUMAN PRESCRIPTION DRUG Keppra XR levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140516 NDA NDA022285 RxPak Division of McKesson Corporation LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65084-462_ff679b27-bdf5-4ccc-a57e-6a4d7e77d90c 65084-462 HUMAN PRESCRIPTION DRUG ALBENZA albendazole TABLET, FILM COATED ORAL 19960611 NDA NDA020666 RxPak Division of McKesson Corporation ALBENDAZOLE 200 mg/1 Antihelminthic [EPC] 65084-463_fbac5f4a-df77-430a-aff8-27f60e85792c 65084-463 HUMAN PRESCRIPTION DRUG Ativan lorazepam TABLET ORAL 20130501 NDA NDA017794 RxPak Division of McKesson Corporation LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65111-002_6b27383b-69bc-88a3-0347-1d02d10dbb3e 65111-002 HUMAN OTC DRUG Arnica Montana Arnica Montana TABLET, ORALLY DISINTEGRATING SUBLINGUAL 19991201 UNAPPROVED HOMEOPATHIC VITAMEDICA INC ARNICA MONTANA 30 [hp_X]/1 65111-004_b3d84159-3824-68b2-3d1f-974cca391d20 65111-004 HUMAN OTC DRUG Recovery Arnica Montana CREAM TOPICAL 20101001 UNAPPROVED HOMEOPATHIC VITAMEDICA INC ARNICA MONTANA 1 [hp_X]/g 65111-005_6f3aeb72-02cb-4dae-8981-74fc7b61a521 65111-005 HUMAN OTC DRUG Arnica Montana 30X HPUS Arnica Montana, TABLET ORAL 20140213 UNAPPROVED HOMEOPATHIC Vitamedica Corporation ARNICA MONTANA 30 [hp_X]/1 65111-005_98dcc738-2c4a-4fc5-aae3-ab06c91f4335 65111-005 HUMAN OTC DRUG ARNICA MONTANA ARNICA MONTANA TABLET ORAL 20141117 UNAPPROVED HOMEOPATHIC VITAMEDICA INC ARNICA MONTANA 30 [hp_X]/1 65113-2372_bd463862-faeb-4ac3-a4eb-bdf6d593737a 65113-2372 HUMAN OTC DRUG AGE INTERVENTION DUALITY BENZOYL PEROXIDE CREAM TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333D G.S. COSMECEUTICAL USA, INC. BENZOYL PEROXIDE 10 g/100g 65113-2373_cf908a6e-f96b-4936-90ee-9ced11c2ef77 65113-2373 HUMAN OTC DRUG AGE INTERVENTION DUALITY MD BENZOYL PEROXIDE CREAM TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333D G.S. COSMECEUTICAL USA, INC. BENZOYL PEROXIDE 10 g/100g 65113-2428_cea721f5-55b7-4f39-a15f-9c91b6f71046 65113-2428 HUMAN OTC DRUG GORILLA WARFARE ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY LOTION TOPICAL 20100430 OTC MONOGRAPH FINAL part350 G.S. COSMECEUTICAL USA, INC. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15 mL/100mL 65113-2432_2daef8de-6967-4615-ac7a-200ed03e61e4 65113-2432 HUMAN OTC DRUG PHOTO DYNAMIC THERAPY SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, and OXYBENZONE LOTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 G.S. COSMECEUTICAL USA, INC. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL 65113-8401_747d192d-0a31-44b3-8dff-71cb2aa196ea 65113-8401 HUMAN OTC DRUG SKIN LIGHTENING COMPLEX HYDROQUINONE CREAM TOPICAL 20091209 OTC MONOGRAPH NOT FINAL part358A G.S. COSMECEUTICAL USA, INC. HYDROQUINONE 2 g/100g 65113-8503_f895144d-17fd-4efa-8b05-87f986871753 65113-8503 HUMAN OTC DRUG NuGLOW DAYTIME THERAPY With SPF 15 AVOBENZONE, OCTINOXATE, and ZINC OXIDE CREAM TOPICAL 20101015 OTC MONOGRAPH NOT FINAL part352 G.S. COSMECEUTICAL USA, INC. AVOBENZONE; OCTINOXATE; ZINC OXIDE 1; 7; 4 g/100g; g/100g; g/100g 65119-345_ffd5a1f9-9794-417c-a195-3d18d76df529 65119-345 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19710101 UNAPPROVED MEDICAL GAS Bronx Welding Supply OXYGEN 99 L/100L 65121-001_d4a51445-85ca-410e-9563-0b7da9fb1b27 65121-001 HUMAN OTC DRUG Cold Spot Point Relief menthol, METHYL SALICYLATE GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL; METHYL SALICYLATE 14; 5 mL/120mL; mL/120mL 65121-001_d9349932-0364-4e9c-9c3a-10ed77414a80 65121-001 HUMAN OTC DRUG Cold Spot Point Relief menthol, METHYL SALICYLATE GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL; METHYL SALICYLATE 115; 38 mL/960mL; mL/960mL 65121-001_d9351ee3-9e8e-4325-8868-c7ccb17d3c3a 65121-001 HUMAN OTC DRUG Cold Spot Point Relief menthol GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL; METHYL SALICYLATE .6; .2 g/5g; g/5g 65121-001_e6a6f198-7521-4c66-9b2f-95a863f552ed 65121-001 HUMAN OTC DRUG Cold Spot Point Relief menthol GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL; MENTHYL SALICYLATE 58; 19 mL/480mL; mL/480mL 65121-001_ea738ac3-347b-4fbd-a049-1893172a18e8 65121-001 HUMAN OTC DRUG Cold Spot Point Relief menthol GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL .46 L/3.8L 65121-002_d07db448-ed4d-4c49-bc25-23400c5d95bc 65121-002 HUMAN OTC DRUG Cold Spot Point Relief menthol OINTMENT TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL 13 mL/90mL 65121-003_57ba08ba-4077-403b-b2b8-d17495d8d27f 65121-003 HUMAN OTC DRUG Cold Spot Point Relief menthol AEROSOL, SPRAY TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL 12 mL/120mL 65121-003_aef8b744-b314-49c0-a222-973a40037471 65121-003 HUMAN OTC DRUG Cold Spot Point Relief menthol AEROSOL, SPRAY TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL 6 mL/60mL 65121-003_d82d99d9-f506-4013-a0b5-975d6f3fd9d4 65121-003 HUMAN OTC DRUG Cold Spot Point Relief menthol AEROSOL, SPRAY TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL 48 mL/480mL 65121-010_088147d9-6c24-4d05-a80a-7fba5f9095e9 65121-010 HUMAN OTC DRUG Hot Spot Point Relief capsaicin GEL TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part348 Pure Source CAPSAICIN 1.5 mL/240mL 65121-010_42f16670-ee65-4cf8-9aa2-2a7bb87a6388 65121-010 HUMAN OTC DRUG Hot Spot Point Relief capsaicin GEL TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part348 Pure Source CAPSAICIN .5 mL/90mL 65121-010_5b607491-41a0-49c7-906a-5e991193d7f5 65121-010 HUMAN OTC DRUG Hot Spot Point Relief capsaicin GEL TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part348 Pure Source CAPSAICIN 5.8 mL/960mL 65121-100_58be1b65-0a75-4b31-b47c-c0ca7ab21e5b 65121-100 HUMAN OTC DRUG Soulus Rp Rash and Pain LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part348 Pure Source Inc LIDOCAINE HYDROCHLORIDE .5 g/100g 65121-101_8475e5de-c4ec-45ce-ac0a-9b8efccc1cf3 65121-101 HUMAN OTC DRUG BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT Regular Strength For Women MINOXIDIL LIQUID TOPICAL 20130815 ANDA ANDA076239 Pure Source Inc. MINOXIDIL 20 mg/mL 65121-102_5deafdfb-0dbb-44cf-9a7c-80c3db6c6022 65121-102 HUMAN OTC DRUG BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT Regular Strength For Men MINOXIDIL LIQUID TOPICAL 20130815 ANDA ANDA076239 Pure Source Inc. MINOXIDIL 50 mg/mL 65121-113_d6290d47-ce75-4f6f-be4f-5687ba29b028 65121-113 HUMAN OTC DRUG OxyRub Pain Relief MENTHOL CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 Pure Source Inc. MENTHOL 1.25 g/100g 65121-121_ad6d381c-f033-4d86-a188-1c939f372d56 65121-121 HUMAN OTC DRUG Arthritis Relief MENTHOL, HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20131125 OTC MONOGRAPH NOT FINAL part348 Pure Source Inc. HISTAMINE DIHYDROCHLORIDE; MENTHOL .025; 3 g/100g; g/100g 65121-208_5895eb53-2c51-4883-8af8-8fc8c1606c47 65121-208 HUMAN OTC DRUG Senophile Dermal PETROLATUM, COD LIVER OINTMENT TOPICAL 20141224 OTC MONOGRAPH FINAL part347 Pure Source, Inc. COD LIVER OIL; PETROLATUM 10; 40 g/100g; g/100g 65121-209_a211eec1-b6a3-4cb9-a446-2cabdafb90a4 65121-209 HUMAN OTC DRUG biochemistry PAIN RELIEF FOOT ACTIVE BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE LIQUID TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part348 Pure Source, Inc. BENZYL ALCOHOL; LIDOCAINE HYDROCHLORIDE 190; 40 mg/mL; mg/mL 65121-304_8ffc56fd-38e9-401d-9100-38c7ea04be7d 65121-304 HUMAN OTC DRUG ocean elements sheer daily moisture broad spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130918 OTC MONOGRAPH NOT FINAL part352 Pure Source Inc. TITANIUM DIOXIDE; ZINC OXIDE 50; 15 mg/mL; mg/mL 65121-397_4d22eda5-1708-4b54-8672-a378da333ad4 65121-397 HUMAN OTC DRUG VIRCIN Advanced wart treatment SALICYLIC ACID CREAM TOPICAL 20140612 OTC MONOGRAPH FINAL part358B Pure Source Inc. SALICYLIC ACID 17 g/100g 65121-403_0078f726-727f-420d-ba12-e5afb26346f1 65121-403 HUMAN OTC DRUG Dr. Freds MIRACLE RUB HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20130606 OTC MONOGRAPH NOT FINAL part348 Pure Source Inc. HISTAMINE DIHYDROCHLORIDE .25 mg/mL 65121-494_e89c1627-9959-42e5-b53d-ac15d3c3ae74 65121-494 HUMAN OTC DRUG Jungle Screen SPF 30 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 Pure Source Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL 65121-495_2f310ad4-b4a5-4ba7-bce7-6c0759f7a69f 65121-495 HUMAN OTC DRUG LCDO. ORLANDO RIVERA ARTHRITIS Topical Analgesic METHYL SALICYLATE, MENTHOL, CAPSAICIN CREAM TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part348 Pure Source Inc. CAPSAICIN; MENTHOL; METHYL SALICYLATE .05; 10; 15 g/100g; g/100g; g/100g 65121-496_10809dc1-8b00-4643-8a68-fb399dc7688e 65121-496 HUMAN OTC DRUG Frankie Avalons ZERO PAIN Original Formula Roll-On Maximum Strength PAIN RELIEVER CAPSAICIN LIQUID TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part348 Pure Source Inc. CAPSAICIN .25 mg/mL 65121-498_b90dfd2c-3c25-4401-a778-d0397e054f7f 65121-498 HUMAN OTC DRUG CORISIN ARTHRITIS PAIN RELIEF CAPSAICIN, MENTHOL GEL TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part348 Pure Source Inc. CAPSAICIN; MENTHOL .025; 10 g/100g; g/100g 65121-562_66a9e0f1-671b-4c98-9443-786a2a8472fe 65121-562 HUMAN OTC DRUG KERANIQUE For Women Hair Regrowth Treatment MINOXIDIL LIQUID TOPICAL 20140206 ANDA ANDA078176 Pure Source, Inc. MINOXIDIL 20 mg/mL 65121-623_1c691b70-50c9-438e-ae19-ee9372ae690e 65121-623 HUMAN OTC DRUG Tag Away Thuja Occidentalis LIQUID TOPICAL 20120831 UNAPPROVED HOMEOPATHIC Pure Source THUJA OCCIDENTALIS WHOLE 6 [hp_X]/15mL 65121-623_9cc8bd99-4e0a-4e27-9654-374bfd631e4d 65121-623 HUMAN OTC DRUG Tag Away Thuja Occidentalis LIQUID TOPICAL 20120818 UNAPPROVED HOMEOPATHIC Pure Source THUJA OCCIDENTALIS BARK 6 [hp_X]/6[hp_X] 65121-682_09775dd9-b8f2-4303-a574-5d48639c143a 65121-682 HUMAN OTC DRUG PHACE BIOACTIVE SOOTHING DAY Plus PRIMER BROAD-SPECTRUM SPF 46 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20140319 OTC MONOGRAPH NOT FINAL part352 Pure Source, Inc. OCTINOXATE; ZINC OXIDE 75; 90 mg/mL; mg/mL 65121-683_900e0120-b35e-4ea6-95e6-26591e244da5 65121-683 HUMAN OTC DRUG PHACE BIOACTIVE CLARIFYING SERUM SALICYLIC ACID CREAM TOPICAL 20140319 OTC MONOGRAPH FINAL part333D Pure Source, Inc. SALICYLIC ACID 15 mg/mL 65121-711_094f5fc2-d1ad-4fa7-9c86-1bb9e3e9060e 65121-711 HUMAN OTC DRUG Tag Away THUJA OCCIDENTALIS LEAFY TWIG LIQUID TOPICAL 20130522 UNAPPROVED HOMEOPATHIC Pure Source, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/mL 65121-712_14b73d71-27b5-4e89-9d69-cdd43b91810f 65121-712 HUMAN OTC DRUG CUREFINI PETROLATUM, COD LIVER OIL OINTMENT TOPICAL 20130117 OTC MONOGRAPH FINAL part347 Pure Source COD LIVER OIL; PETROLATUM 100; 300 mg/mL; mg/mL 65121-715_e4679a97-721b-4e78-a2b6-341337ef94b1 65121-715 HUMAN OTC DRUG ecolyptus pain relieving muscle rub MENTHOL CREAM TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part348 Pure Source, Inc. MENTHOL 60 mg/mL 65121-883_4eabc5c5-e1bc-4588-83a2-34a11ef57c46 65121-883 HUMAN OTC DRUG DR. MERCOLA Sunscreen Broad Spectrum SPF-30 ZINC OXIDE CREAM TOPICAL 20140428 OTC MONOGRAPH NOT FINAL part352 Pure Source Inc ZINC OXIDE 200 mg/mL 65121-884_1883bce0-c431-4b04-b8d8-77eb9525c56b 65121-884 HUMAN OTC DRUG DR. MERCOLA Sunscreen Broad Spectrum SPF-15 ZINC OXIDE CREAM TOPICAL 20140428 OTC MONOGRAPH NOT FINAL part352 Pure Source Inc ZINC OXIDE 95 mg/mL 65121-885_430b3001-dae7-4a7b-be89-0f3f17ddf262 65121-885 HUMAN OTC DRUG GranuLotion MENTHOL, ZINC OXIDE LOTION TOPICAL 20140326 OTC MONOGRAPH FINAL part346 Pure Source Inc MENTHOL; ZINC OXIDE .11; 5.1 g/100g; g/100g 65121-886_8893f639-44bc-4892-b33c-8f542d069b1c 65121-886 HUMAN OTC DRUG DR. MERCOLA Sunscreen SPF-50 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140428 OTC MONOGRAPH NOT FINAL part352 Pure Source Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 225 mg/mL; mg/mL 65121-993_895cc833-9ba1-4396-bbf5-93285ea2e2e2 65121-993 HUMAN OTC DRUG H-Releve Anti-Itch HYDROCORTISONE CREAM TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part348 Pure Source Inc. HYDROCORTISONE 1 g/100g 65121-994_44ed64a7-384c-4f0e-9dd0-6908d44896bd 65121-994 HUMAN OTC DRUG H-Releve Hemorrhoidal LIDOCAINE CREAM TOPICAL 20130815 OTC MONOGRAPH FINAL part346 Pure Source Inc. LIDOCAINE 4 g/100g 65131-097_d2657d36-4092-49a3-b8f9-1d9238edca99 65131-097 HUMAN OTC DRUG BRONCOCHEM COLD AND FLU TEA ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE GRANULE, FOR SOLUTION ORAL 20130901 OTC MONOGRAPH NOT FINAL part343 LABORATORIO MAGNACHEM INTERNATIONAL SRL ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 500; 4 mg/13g; mg/13g 65133-110_00cd7242-44f3-45d5-98d6-faa2a57145bb 65133-110 HUMAN OTC DRUG Aire-Master Alcohol GEL TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333E Aire-Master of America, Inc. ALCOHOL 60 mL/100mL 65133-120_c6b88516-3eac-4439-9d0a-2c1a071832dc 65133-120 HUMAN OTC DRUG Aire-Master Alcohol GEL TOPICAL 20071212 OTC MONOGRAPH NOT FINAL part333E Aire-Master of America, Inc. ALCOHOL 62 mL/100mL 65133-130_e2cffd30-525d-4e50-9903-23031a345e56 65133-130 HUMAN OTC DRUG Aire-Master Sanitizer Gel vit e/a Alcohol GEL TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333E Aire-Master of America, Inc ALCOHOL 60 mL/100mL 65133-140_1a02eda6-798b-435d-84d3-bd64a8021e0f 65133-140 HUMAN OTC DRUG Aire-Master Alcohol GEL TOPICAL 20110421 OTC MONOGRAPH NOT FINAL part333E Aire-Master of America, Inc. ALCOHOL 70 mL/100mL 65133-150_c825bcc7-a25b-4b3c-a0ac-d07b49e8d4a7 65133-150 HUMAN OTC DRUG Aire-Master Alcohol LIQUID TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333E Aire-Master of America, Inc. ALCOHOL 60 mL/100mL 65133-160_a4ef7848-fffa-40c8-9bb3-113a323d9c8e 65133-160 HUMAN OTC DRUG Aire-Master Liquid spray handsanitizer LIQUID TOPICAL 20120507 OTC MONOGRAPH NOT FINAL part333E Aire-Master of America, Inc. ALCOHOL 62 mL/100mL 65141-0001_6c7ca8db-9b07-41aa-b9a8-24a7d73ab774 65141-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990524 UNAPPROVED MEDICAL GAS CareFirst of Fort Wayne, Inc. dba Advanced Healthcare OXYGEN 99 L/100L 65156-515_329e7cc1-9fe7-4345-8ef5-128ae22cb3cb 65156-515 HUMAN OTC DRUG Hygiene Master Instant Hand Sanitizer ethanol GEL TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Kayline Company ETHANOL 600 mL/1000mL 65162-003_e058980d-ea54-4119-9a15-47b460c90445 65162-003 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine SOLUTION ORAL 20091007 ANDA ANDA090765 Amneal Pharmaceuticals CETIRIZINE HYDROCHLORIDE 5 mg/5mL 65162-005_966b06b8-782d-437c-9bdb-3aec48f57dc8 65162-005 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine SOLUTION ORAL 20091007 ANDA ANDA090765 Amneal Pharmaceuticals CETIRIZINE HYDROCHLORIDE 5 mg/5mL 65162-006_3e1415b2-9757-49af-b4dd-6e0dba329275 65162-006 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100621 ANDA ANDA078477 Amneal Pharmaceuticals of New York, LLC AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 65162-007_3e1415b2-9757-49af-b4dd-6e0dba329275 65162-007 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100621 ANDA ANDA078477 Amneal Pharmaceuticals of New York, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 65162-008_3e1415b2-9757-49af-b4dd-6e0dba329275 65162-008 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100621 ANDA ANDA078477 Amneal Pharmaceuticals of New York, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 65162-033_fb61ed37-a227-480c-aee9-66e1cd5eb469 65162-033 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20080529 ANDA ANDA040779 Amneal Pharmaceuticals, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 65162-045_118c2ce0-2573-4de8-861a-3da2bb79e97a 65162-045 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine TABLET ORAL 20100121 ANDA ANDA078780 Amneal Pharmaceuticals CETIRIZINE HYDROCHLORIDE 5 mg/1 65162-046_4061bbde-90e8-446f-b2d9-678879549866 65162-046 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine TABLET ORAL 20100121 ANDA ANDA078780 Amneal Pharmaceuticals CETIRIZINE HYDROCHLORIDE 10 mg/1 65162-047_f8467c3b-0737-4c33-a307-f479a56f9647 65162-047 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone TABLET ORAL 20121030 ANDA ANDA203638 Amneal Pharmaceuticals of New York, LLC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 65162-048_f8467c3b-0737-4c33-a307-f479a56f9647 65162-048 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone TABLET ORAL 20121030 ANDA ANDA203638 Amneal Pharmaceuticals of New York, LLC OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 65162-049_f8467c3b-0737-4c33-a307-f479a56f9647 65162-049 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone TABLET ORAL 20121030 ANDA ANDA203638 Amneal Pharmaceuticals of New York, LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 65162-050_f8467c3b-0737-4c33-a307-f479a56f9647 65162-050 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone TABLET ORAL 20121030 ANDA ANDA203638 Amneal Pharmaceuticals of New York, LLC OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 65162-051_f8467c3b-0737-4c33-a307-f479a56f9647 65162-051 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone TABLET ORAL 20121030 ANDA ANDA203638 Amneal Pharmaceuticals of New York, LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 65162-052_0f07a0c9-a635-4b2e-bf66-920284bb963e 65162-052 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100913 ANDA ANDA077289 Amneal Pharmaceuticals of New York, LLC CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65162-053_0f07a0c9-a635-4b2e-bf66-920284bb963e 65162-053 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100913 ANDA ANDA077289 Amneal Pharmaceuticals of New York, LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65162-054_0f07a0c9-a635-4b2e-bf66-920284bb963e 65162-054 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100913 ANDA ANDA077289 Amneal Pharmaceuticals of New York, LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65162-101_d8798d5b-4ab3-434e-995b-3cc87e20c59a 65162-101 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Amneal Pharmaceuticals of New York, LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-102_d8798d5b-4ab3-434e-995b-3cc87e20c59a 65162-102 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Amneal Pharmaceuticals of New York, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-103_d8798d5b-4ab3-434e-995b-3cc87e20c59a 65162-103 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Amneal Pharmaceuticals of New York, LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-145_be2bac86-6f22-471d-a517-c7b7a6e5995b 65162-145 HUMAN OTC DRUG Cetirizine Hydrochloride Hives Relief Cetirizine TABLET ORAL 20100121 ANDA ANDA078780 Amneal Pharmaceuticals CETIRIZINE HYDROCHLORIDE 5 mg/1 65162-146_36129c76-bfc7-4f3f-89bd-935bf221f9d6 65162-146 HUMAN OTC DRUG Cetirizine Hydrochloride Hives Relief Cetirizine TABLET ORAL 20100121 ANDA ANDA078780 Amneal Pharmaceuticals CETIRIZINE HYDROCHLORIDE 10 mg/1 65162-174_6fc4d215-86ac-416e-8e9a-5f84b78ef2db 65162-174 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin TABLET ORAL 20090601 ANDA ANDA077880 Amneal Pharmaceuticals METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65162-175_6fc4d215-86ac-416e-8e9a-5f84b78ef2db 65162-175 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin TABLET ORAL 20090601 ANDA ANDA077880 Amneal Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65162-177_6fc4d215-86ac-416e-8e9a-5f84b78ef2db 65162-177 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin TABLET ORAL 20090601 ANDA ANDA077880 Amneal Pharmaceuticals METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65162-188_65ccac27-6323-4fcd-932b-282ba26730da 65162-188 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Amneal Pharmaceuticals of New York, LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65162-189_65ccac27-6323-4fcd-932b-282ba26730da 65162-189 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Amneal Pharmaceuticals of New York, LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65162-190_65ccac27-6323-4fcd-932b-282ba26730da 65162-190 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Amneal Pharmaceuticals of New York, LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65162-193_ded1f570-ab4b-499f-942e-60c87f04bd81 65162-193 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Amneal Pharmaceuticals of New York, LLC NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65162-194_ded1f570-ab4b-499f-942e-60c87f04bd81 65162-194 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Amneal Pharmaceuticals of New York, LLC NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65162-207_044340c0-94a0-4c65-99a1-dd06595d7546 65162-207 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131101 ANDA ANDA040778 Amneal Pharmaceuticals of New York, LLC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 65162-209_95b772aa-9fb1-4ab2-abef-2bb9ed6b2687 65162-209 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET ORAL 20140430 ANDA ANDA078195 Amneal Pharmaceuticals of New York, LLC NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 65162-212_6e98aac0-71bc-44bc-9ada-8f1b2dbbb090 65162-212 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE ORAL 20091216 ANDA ANDA040765 Amneal Pharmaceuticals of New York, LLC PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-218_717c860a-788b-40f3-b057-beb628baabd1 65162-218 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 Amneal Pharmaceuticals of New York, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65162-219_717c860a-788b-40f3-b057-beb628baabd1 65162-219 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 Amneal Pharmaceuticals of New York, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65162-220_717c860a-788b-40f3-b057-beb628baabd1 65162-220 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 Amneal Pharmaceuticals of New York, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65162-300_cccb9e14-d921-4d56-a9a0-5db5b752fc75 65162-300 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20100511 ANDA ANDA079098 Amneal Pharmaceuticals of New York, LLC VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65162-302_cccb9e14-d921-4d56-a9a0-5db5b752fc75 65162-302 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20100511 ANDA ANDA079098 Amneal Pharmaceuticals of New York, LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65162-305_cccb9e14-d921-4d56-a9a0-5db5b752fc75 65162-305 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20100511 ANDA ANDA079098 Amneal Pharmaceuticals of New York, LLC VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65162-306_cccb9e14-d921-4d56-a9a0-5db5b752fc75 65162-306 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20100511 ANDA ANDA079098 Amneal Pharmaceuticals of New York, LLC VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65162-307_cccb9e14-d921-4d56-a9a0-5db5b752fc75 65162-307 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20100511 ANDA ANDA079098 Amneal Pharmaceuticals of New York, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65162-316_33e5b594-340c-440a-a914-1bc255a401f1 65162-316 HUMAN PRESCRIPTION DRUG Lomedia 24 Fe Norethindrone Acetate and Ethinyl Estradiol KIT 20131220 ANDA ANDA078267 Amneal Pharmaceuticals of New York, LLC 65162-347_83f380c0-a952-4540-bd78-18a44778768f 65162-347 HUMAN PRESCRIPTION DRUG Zenchent FE Norethindrone and Ethinyl Estradiol KIT 20110926 ANDA ANDA078892 Amneal Pharmaceuticals of New York, LLC 65162-350_f7a2bc2d-1734-4b7f-a380-0f6bc34d9cee 65162-350 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20091216 OTC MONOGRAPH FINAL part343 Amneal Pharmaceuticals ACETAMINOPHEN 325 mg/1 65162-351_d0777805-a448-4008-817f-38daa7f0c9a4 65162-351 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET ORAL 20121108 ANDA ANDA202025 Amneal Pharmaceuticals, LLC SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 65162-356_bff016c0-424c-4fef-b2de-01412562470b 65162-356 HUMAN OTC DRUG Ibuprofen Pain Reliever/Fever Reducer Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130329 ANDA ANDA202300 Amneal Pharmaceuticals IBUPROFEN 200 mg/1 65162-361_fbbe0b01-3c35-4451-bc4e-08128d010156 65162-361 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091202 ANDA ANDA040625 Amneal Pharmaceuticals, LLC FOLIC ACID 1 mg/1 65162-414_f138d1db-c5ca-4292-b27b-8e4b0c98dab6 65162-414 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET ORAL 20130930 ANDA ANDA203751 Amneal Pharmaceuticals of New York, LLC CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 65162-415_d6722371-c21a-4dfc-a3e6-5b852b77d43b 65162-415 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20130222 ANDA ANDA203136 Amneal Pharmaceuticals, LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 65162-416_d6722371-c21a-4dfc-a3e6-5b852b77d43b 65162-416 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20130222 ANDA ANDA203136 Amneal Pharmaceuticals, LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII 65162-441_919bcc5b-7175-4360-abee-1a137ec96e53 65162-441 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20100212 ANDA ANDA201451 Amneal Pharmaceuticals, LLC MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 65162-442_919bcc5b-7175-4360-abee-1a137ec96e53 65162-442 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20100212 ANDA ANDA201451 Amneal Pharmaceuticals, LLC MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 65162-444_919bcc5b-7175-4360-abee-1a137ec96e53 65162-444 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20100212 ANDA ANDA201451 Amneal Pharmaceuticals, LLC MECLIZINE HYDROCHLORIDE 50 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 65162-468_2f6464fd-3fd9-4963-94c8-e438cce94f15 65162-468 HUMAN PRESCRIPTION DRUG Clindamycin Palmitate Hydrochloride Clindamycin Palmitate Hydrochloride POWDER, FOR SOLUTION ORAL 20130902 ANDA ANDA203513 Amneal Pharmaceuticals of New York, LLC CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 65162-475_cd236b39-3da0-4afc-8196-95e7894eca1d 65162-475 HUMAN PRESCRIPTION DRUG Norethindrone Acetate Norethindrone TABLET ORAL 20090701 ANDA ANDA200275 Amneal Pharmaceuticals NORETHINDRONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 65162-506_b9359230-3e72-4127-addf-2a4189330008 65162-506 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20101206 ANDA ANDA091549 Amneal Pharmaceuticals INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65162-511_ca1c09a4-ec05-4ebe-9c38-5ab8d5b4313f 65162-511 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20100802 ANDA ANDA091426 Amneal Pharmaceuticals of New York, LLC SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 65162-512_401aea08-edcc-4beb-9d8c-aa37245338b8 65162-512 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20100924 UNAPPROVED DRUG OTHER Amneal Pharmaceuticals SALSALATE 500 mg/1 65162-513_401aea08-edcc-4beb-9d8c-aa37245338b8 65162-513 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20100924 UNAPPROVED DRUG OTHER Amneal Pharmaceuticals SALSALATE 750 mg/1 65162-514_ca1c09a4-ec05-4ebe-9c38-5ab8d5b4313f 65162-514 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20100802 ANDA ANDA091426 Amneal Pharmaceuticals of New York, LLC SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 65162-515_ca1c09a4-ec05-4ebe-9c38-5ab8d5b4313f 65162-515 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20100802 ANDA ANDA091426 Amneal Pharmaceuticals of New York, LLC SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 65162-517_32b5816d-7c22-4023-a245-b4e5b4f8cade 65162-517 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Amneal Pharmaceuticals PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 65162-520_32b5816d-7c22-4023-a245-b4e5b4f8cade 65162-520 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Amneal Pharmaceuticals PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 65162-521_d4c70548-9696-4e44-9e91-133948ad1e6a 65162-521 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Amneal Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 65162-522_d4c70548-9696-4e44-9e91-133948ad1e6a 65162-522 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Amneal Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 65162-528_1a9f7923-3b6e-46a3-a3f7-2fc6c121373c 65162-528 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20130228 ANDA ANDA090767 Amneal Pharmaceuticals of New York, LLC LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-529_1a9f7923-3b6e-46a3-a3f7-2fc6c121373c 65162-529 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20130228 ANDA ANDA090767 Amneal Pharmaceuticals of New York, LLC LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-536_66cb91e7-0780-4800-8590-794455196a1b 65162-536 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 Amneal Pharmaceuticals of NY LLC BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 65162-537_66cb91e7-0780-4800-8590-794455196a1b 65162-537 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 Amneal Pharmaceuticals of NY LLC BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 65162-538_1a9f7923-3b6e-46a3-a3f7-2fc6c121373c 65162-538 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20130228 ANDA ANDA090767 Amneal Pharmaceuticals of New York, LLC LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-539_1a9f7923-3b6e-46a3-a3f7-2fc6c121373c 65162-539 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20130228 ANDA ANDA090767 Amneal Pharmaceuticals of New York, LLC LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-541_8af4c089-8d97-445c-ba90-d45ab268979f 65162-541 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100218 ANDA ANDA078218 Amneal Pharmaceuticals CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 65162-542_e58924cd-e819-4527-9101-d181aa4882f0 65162-542 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20130222 ANDA ANDA202128 Amneal Pharmaceuticals POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 65162-544_36e4a4a6-d51a-4806-9d41-df0bfeb0d7c7 65162-544 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20091224 ANDA ANDA040866 Amneal Pharmaceuticals PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-545_36e4a4a6-d51a-4806-9d41-df0bfeb0d7c7 65162-545 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20091224 ANDA ANDA040866 Amneal Pharmaceuticals PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-553_eccdf309-eb53-4f71-8ab0-a3cc97fb2f87 65162-553 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20130531 ANDA ANDA203399 Amneal Pharmaceuticals, LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 65162-554_8849f977-0448-4a3e-bd96-ee1b8791fefa 65162-554 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET ORAL 20100401 ANDA ANDA065425 Amneal Pharmaceuticals DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 65162-555_8849f977-0448-4a3e-bd96-ee1b8791fefa 65162-555 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET ORAL 20100401 ANDA ANDA065425 Amneal Pharmaceuticals DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 65162-571_430b6506-6c55-46de-a99b-e0d980eadc96 65162-571 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100401 ANDA ANDA040855 Amneal Pharmaceuticals BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 65162-572_430b6506-6c55-46de-a99b-e0d980eadc96 65162-572 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100401 ANDA ANDA040855 Amneal Pharmaceuticals BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 65162-573_430b6506-6c55-46de-a99b-e0d980eadc96 65162-573 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100401 ANDA ANDA040855 Amneal Pharmaceuticals BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 65162-574_430b6506-6c55-46de-a99b-e0d980eadc96 65162-574 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100401 ANDA ANDA040855 Amneal Pharmaceuticals BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 65162-590_896ec38b-9564-492d-8e4e-b6238b019bd3 65162-590 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20141008 ANDA ANDA201658 Amneal Pharmaceuticals of New York, LLC CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 65162-602_32b048b0-47ce-472a-9c95-2d3d7213a456 65162-602 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20091216 OTC MONOGRAPH FINAL part343 Amneal Pharmaceuticals ACETAMINOPHEN 500 mg/1 65162-607_32b048b0-47ce-472a-9c95-2d3d7213a456 65162-607 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20091216 OTC MONOGRAPH FINAL part343 Amneal Pharmaceuticals ACETAMINOPHEN 500 mg/1 65162-617_66594186-a1a1-440d-aced-114bfd27ab56 65162-617 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Amneal Pharmaceuticals of New York, LLC ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 65162-627_2899c52b-09f2-46ba-b7df-c45ecb41d64d 65162-627 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 Amneal Pharmaceuticals of New York, LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 65162-641_0156fd39-7bb0-40ba-9464-d5bb46b48b7c 65162-641 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20091201 ANDA ANDA075442 Amneal Pharmaceuticals of New York, LLC FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] 65162-642_0156fd39-7bb0-40ba-9464-d5bb46b48b7c 65162-642 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20091201 ANDA ANDA075442 Amneal Pharmaceuticals of New York, LLC FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] 65162-643_0156fd39-7bb0-40ba-9464-d5bb46b48b7c 65162-643 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20091201 ANDA ANDA075442 Amneal Pharmaceuticals of New York, LLC FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] 65162-649_e5508f0d-48ec-4460-a95d-36187b3c7eef 65162-649 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine SUSPENSION ORAL 20120604 ANDA ANDA202961 Amneal Pharmaceuticals of New York, LLC OXCARBAZEPINE 300 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-659_8cb170bc-f539-4d27-9133-47a956ecf21c 65162-659 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine SOLUTION ORAL 20091214 ANDA ANDA090576 Amneal Pharmaceuticals NIZATIDINE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 65162-664_baf8cc8b-1e88-4214-b4f3-9562e41bb621 65162-664 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SOLUTION ORAL 20100312 ANDA ANDA078312 Amneal Pharmaceuticals RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 65162-667_42511615-d934-499c-afdf-f8d06da29d7f 65162-667 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20091201 ANDA ANDA078345 Amneal Pharmaceuticals PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 65162-668_3a2826b9-7c80-4f0c-b154-bc02ec55b658 65162-668 HUMAN PRESCRIPTION DRUG PRENATAL PLUS VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE TABLET, FILM COATED ORAL 20091202 UNAPPROVED DRUG OTHER Amneal Pharmaceuticals, LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE 22; 920; 120; 200; 400; 2; 12; 27; 1; 20; 10; 3; 1.84; 3080; 25 mg/1; [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 65162-669_f1931f84-682c-43bf-a02b-b458a85d497d 65162-669 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20091201 ANDA ANDA075047 Amneal Pharmaceuticals, LLC ACEBUTOLOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65162-670_f1931f84-682c-43bf-a02b-b458a85d497d 65162-670 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20091201 ANDA ANDA075047 Amneal Pharmaceuticals, LLC ACEBUTOLOL HYDROCHLORIDE 400 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65162-672_010ab916-bc42-4e69-85d6-6585fc34226d 65162-672 HUMAN OTC DRUG Ibuprofen Pain Reliever/ Fever Reducer Ibuprofen SUSPENSION ORAL 20111112 ANDA ANDA200457 Amneal Pharmaceuticals IBUPROFEN 100 mg/5mL 65162-673_b24e1de9-2f2f-4a55-872f-63a5bf67b932 65162-673 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20110531 ANDA ANDA091384 Amneal Pharmaceuticals of New York, LLC RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] 65162-678_b6ca5bbe-2e88-4fe2-b732-1d38a1da97aa 65162-678 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine SOLUTION ORAL 20091230 ANDA ANDA040882 Amneal Pharmaceuticals, LLC PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 65162-679_ee90bcbe-e00d-471d-a67d-c76219081527 65162-679 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Phenylephrine Hydrochloride Promethazine and Phenylephrine SOLUTION ORAL 20090825 ANDA ANDA040902 Amneal Pharmaceuticals PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 5; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 65162-680_9fdb590d-9632-4db0-a1c7-f4ffb22dfc70 65162-680 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextomethorphan Hydrobromide Promethazine Hydrochloride and Dextomethorphan Hydrobromide SOLUTION ORAL 20100331 ANDA ANDA090575 Amneal Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] 65162-684_b91292b2-51dd-4bbc-ad96-c2adc0314243 65162-684 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine SOLUTION ORAL 20091007 ANDA ANDA090766 Amneal Pharmaceuticals CETIRIZINE HYDROCHLORIDE 5 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 65162-685_e6f9a70a-458b-41a1-9075-fbd7709b35aa 65162-685 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20091027 ANDA ANDA090992 Amneal Pharmaceuticals of New York, LLC LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-686_8e2ca93c-0426-45a9-8520-ddadafef6672 65162-686 HUMAN PRESCRIPTION DRUG Felbamate Felbamate SUSPENSION ORAL 20111216 ANDA ANDA202385 Amneal Pharmaceuticals FELBAMATE 600 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-687_5c796954-3952-4203-902e-e7fc6638c8ea 65162-687 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam CONCENTRATE ORAL 20100201 ANDA ANDA091383 Amneal Pharmaceuticals, LLC LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65162-689_f9265ca2-e473-450b-8c36-b4be187df548 65162-689 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin SUSPENSION ORAL 20110324 ANDA ANDA201679 Amneal Pharmaceuticals of New York, LLC NITROFURANTOIN 25 mg/5mL Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 65162-691_fda508e9-3b76-491f-b177-1f028b738e11 65162-691 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron SOLUTION ORAL 20101217 ANDA ANDA091483 Amneal Pharmaceuticals of New York, LLC ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 65162-693_5d952312-6afe-4fb0-aee5-bee7ea5f9eea 65162-693 HUMAN PRESCRIPTION DRUG Atovaquone Atovaquone SUSPENSION ORAL 20111209 ANDA ANDA202960 Amneal Pharmaceuticals, LLC ATOVAQUONE 750 mg/5mL Antimalarial [EPC],Antiprotozoal [EPC] 65162-698_e956f1d7-769f-473c-b685-579f2c47e7ff 65162-698 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin SOLUTION ORAL 20110930 ANDA ANDA202024 Amneal Pharmaceuticals of New York, LLC GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-702_7e067c03-321b-4867-83b6-12413b93e112 65162-702 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL AURICULAR (OTIC) 20111017 ANDA ANDA091306 Amneal Pharmaceuticals, LLC FLUOCINOLONE ACETONIDE .11 mg/20mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 65162-703_86f09bb4-6e2c-4c20-9b76-ee36cd627975 65162-703 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL TOPICAL 20111017 ANDA ANDA201759 Amneal Pharmaceuticals, LLC FLUOCINOLONE ACETONIDE .11 mg/118.28mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 65162-704_67e604ed-038c-4237-b711-66a7dc70f47b 65162-704 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL TOPICAL 20111017 ANDA ANDA201764 Amneal Pharmaceuticals, LLC FLUOCINOLONE ACETONIDE .11 mg/118.28mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 65162-705_b9ad28b9-3667-4566-b661-a1635955d962 65162-705 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram SOLUTION ORAL 20110903 ANDA ANDA202227 Amneal Pharmaceuticals of New York, LLC ESCITALOPRAM OXALATE 5 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65162-711_042bf3b6-8c88-4b30-b034-0f4ca1b8e8ea 65162-711 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine Hydrochloride TABLET ORAL 19981125 ANDA ANDA075109 Amneal Pharmaceuticals GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 65162-713_042bf3b6-8c88-4b30-b034-0f4ca1b8e8ea 65162-713 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine Hydrochloride TABLET ORAL 19981125 ANDA ANDA075109 Amneal Pharmaceuticals GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 65162-734_95dbc5f9-1253-4164-ad97-62249b751fb0 65162-734 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20110916 ANDA ANDA201680 Amneal Pharmaceuticals FELBAMATE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-735_95dbc5f9-1253-4164-ad97-62249b751fb0 65162-735 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20110916 ANDA ANDA201680 Amneal Pharmaceuticals FELBAMATE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-745_d4c70548-9696-4e44-9e91-133948ad1e6a 65162-745 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Amneal Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 65162-751_bcc86c49-cb25-4907-b8f2-514826a20850 65162-751 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Amneal Pharmaceuticals BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 65162-752_bcc86c49-cb25-4907-b8f2-514826a20850 65162-752 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Amneal Pharmaceuticals BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 65162-753_bcc86c49-cb25-4907-b8f2-514826a20850 65162-753 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Amneal Pharmaceuticals BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 65162-754_bcc86c49-cb25-4907-b8f2-514826a20850 65162-754 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Amneal Pharmaceuticals BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 65162-761_eb1f77e0-a70f-470b-9199-1b9b8d6cc4fa 65162-761 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals, LLC WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65162-762_eb1f77e0-a70f-470b-9199-1b9b8d6cc4fa 65162-762 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals, LLC WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65162-763_eb1f77e0-a70f-470b-9199-1b9b8d6cc4fa 65162-763 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals, LLC WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65162-764_eb1f77e0-a70f-470b-9199-1b9b8d6cc4fa 65162-764 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals, LLC WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65162-765_eb1f77e0-a70f-470b-9199-1b9b8d6cc4fa 65162-765 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals, LLC WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65162-766_eb1f77e0-a70f-470b-9199-1b9b8d6cc4fa 65162-766 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals, LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65162-767_eb1f77e0-a70f-470b-9199-1b9b8d6cc4fa 65162-767 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals, LLC WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65162-768_eb1f77e0-a70f-470b-9199-1b9b8d6cc4fa 65162-768 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals, LLC WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65162-769_eb1f77e0-a70f-470b-9199-1b9b8d6cc4fa 65162-769 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals, LLC WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65162-770_7e0d1d25-746f-4280-aee9-6f33e7ac5034 65162-770 HUMAN OTC DRUG Ibuprofen Pain Reliever/Fever Reducer Ibuprofen CAPSULE, LIQUID FILLED ORAL 20110915 ANDA ANDA202300 Amneal Pharmaceuticals IBUPROFEN 200 mg/1 65162-809_d454635a-c186-46cb-b673-fd10b2d08165 65162-809 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Amneal Pharmaceuticals, LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65162-810_d454635a-c186-46cb-b673-fd10b2d08165 65162-810 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Amneal Pharmaceuticals, LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65162-812_d454635a-c186-46cb-b673-fd10b2d08165 65162-812 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Amneal Pharmaceuticals, LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65162-813_d454635a-c186-46cb-b673-fd10b2d08165 65162-813 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Amneal Pharmaceuticals, LLC ALPRAZOLAM 3 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65162-835_7523677b-cf23-4602-8445-d6bf7eae1c2c 65162-835 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir OINTMENT TOPICAL 20140103 ANDA ANDA204605 Amneal Pharmaceuticals of New York, LLC ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 65162-955_da4c5225-1b4c-4440-b656-6750f8b349c6 65162-955 HUMAN PRESCRIPTION DRUG Esomeprazole strontium Esomeprazole strontium CAPSULE, DELAYED RELEASE ORAL 20130812 NDA NDA202342 Amneal Pharmaceuticals of New York, LLC ESOMEPRAZOLE STRONTIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 65162-957_da4c5225-1b4c-4440-b656-6750f8b349c6 65162-957 HUMAN PRESCRIPTION DRUG Esomeprazole strontium Esomeprazole strontium CAPSULE, DELAYED RELEASE ORAL 20130812 NDA NDA202342 Amneal Pharmaceuticals of New York, LLC ESOMEPRAZOLE STRONTIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 65162-998_8672cb30-7e28-48b3-9056-0257b5bd773b 65162-998 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 20130517 ANDA ANDA078476 Amneal Pharmaceuticals of New York, LLC FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65162-999_8672cb30-7e28-48b3-9056-0257b5bd773b 65162-999 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 20130517 ANDA ANDA078476 Amneal Pharmaceuticals of New York, LLC FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65174-270_6d1f9e66-4096-8142-f473-4053110e5752 65174-270 HUMAN PRESCRIPTION DRUG DRAXIMAGE MAA Kit for the Preparation of Technetium Tc 99m Albumin Aggregated INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19871230 NDA NDA017881 Jubilant DraxImage Inc. ALBUMIN AGGREGATED 2.5 mg/1 65174-288_306ed5c1-8d87-0337-3528-36d7cf1c65dc 65174-288 HUMAN PRESCRIPTION DRUG Pentetic Acid Pentetic Acid INJECTION INTRAVENOUS 19891229 NDA NDA018511 Jubilant DraxImage Inc. PENTETIC ACID 20 mg/1 Lead Chelating Activity [MoA],Lead Chelator [EPC] 65174-461_732f90b0-38fa-9b70-4aa0-e2697c632209 65174-461 HUMAN PRESCRIPTION DRUG Sodium Iodide I 131 Diagnostic Sodium Iodide I 131 CAPSULE ORAL 20060501 NDA NDA021305 Jubilant DraxImage Inc. SODIUM IODIDE I-131 100 mCi/1 65174-660_70497879-c320-e6ac-a1a7-5b1e7f104c3b 65174-660 HUMAN PRESCRIPTION DRUG Technetium Tc 99m Medronate Technetium Tc 99m Medronate INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20040227 NDA NDA018035 Jubilant DraxImage Inc MEDRONIC ACID 25 mg/1 65174-880_76c809cf-5a96-9763-04ac-27235b3af105 65174-880 HUMAN PRESCRIPTION DRUG HICON Sodium Iodide I 131 SOLUTION ORAL 20030407 NDA NDA021305 Jubilant DraxImage Inc. SODIUM IODIDE I-131 1 mCi/mL 65193-144_a7794f9e-1dd2-438e-bf10-47114b7fab5a 65193-144 HUMAN OTC DRUG Ephed Plus Sinus Acetaminophen, Pseudoephedrine HCl TABLET ORAL 20111018 OTC MONOGRAPH FINAL part341 Dickey Consumer Products DBA DMD ACETAMINOPHEN; PSEUDOEPHEDRINE HYDROCHLORIDE 325; 30 mg/1; mg/1 65193-320_719d5a47-9b03-4ec0-91cb-404db1d2dee8 65193-320 HUMAN OTC DRUG Ephed Asthma ephedrine hydrochloride, guaifenesin TABLET ORAL 20111213 OTC MONOGRAPH FINAL part341 Dickey Consumer Products DBA DMD EPHEDRINE HYDROCHLORIDE; GUAIFENESIN 25; 200 mg/1; mg/1 65193-939_fd5ccac9-a54a-4284-80c8-a5f035c5d9e6 65193-939 HUMAN OTC DRUG Ephed 60 Pseudoephedrine LIQUID ORAL 20111010 OTC MONOGRAPH FINAL part341 Dickey Consumer Products DBA DMD PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/60mL 65197-001_826b49cb-da63-4d04-9d4b-c502f9b09f3f 65197-001 HUMAN PRESCRIPTION DRUG Dibenzyline Phenoxybenzamine Hydrochloride CAPSULE ORAL 19991001 NDA NDA008708 WellSpring Pharmaceutical Corporation PHENOXYBENZAMINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 65197-002_fea74c6e-be97-48b5-8d3a-30b397894d4e 65197-002 HUMAN PRESCRIPTION DRUG Dyrenium Triamterene CAPSULE ORAL 19991001 NDA NDA013174 WellSpring Pharmaceutical Corporation TRIAMTERENE 50 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 65197-003_fea74c6e-be97-48b5-8d3a-30b397894d4e 65197-003 HUMAN PRESCRIPTION DRUG Dyrenium Triamterene CAPSULE ORAL 19990101 NDA NDA013174 WellSpring Pharmaceutical Corporation TRIAMTERENE 100 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 65197-103_9313b94b-8193-4200-b190-153f3200aeb9 65197-103 HUMAN OTC DRUG Micatin Miconazole nitrate CREAM TOPICAL 20090624 OTC MONOGRAPH FINAL part333C WellSpring Pharmaceutical Corporation MICONAZOLE NITRATE 20 mg/g 65197-201_6a746d0e-05d0-4c92-a81a-dc439bb81b8e 65197-201 HUMAN OTC DRUG Emetrol Cherry phosphorated carbohydrate SOLUTION ORAL 20090624 OTC MONOGRAPH NOT FINAL part357 WellSpring Pharmaceutical Corporation PHOSPHORIC ACID; SUCROSE 21.5; 3.74 mg/5mL; g/5mL 65197-212_c9e8e716-c307-4933-87d7-6e35cf0d8c8e 65197-212 HUMAN OTC DRUG Childrens Emetrol Dye Free Grape phosphorated carbohydrate SOLUTION ORAL 20130421 UNAPPROVED DRUG OTHER WellSpring Pharmaceutical Corporation PHOSPHORIC ACID; SUCROSE 21.5; 3.74 mg/5mL; g/5mL 65197-275_a876015a-485a-4070-8c22-2dfa931f1cb0 65197-275 HUMAN OTC DRUG BONINE meclizine hydrochloride TABLET, CHEWABLE ORAL 20141215 OTC MONOGRAPH FINAL part336 WellSpring Pharmaceutical Corporation MECLIZINE HYDROCHLORIDE 25 mg/1 65197-300_3ae9fa7f-9216-4ee2-b343-b846cd210e1d 65197-300 HUMAN OTC DRUG Gelusil aluminum hydroxide dried gel and magnesium hydroxide and simethicone TABLET, CHEWABLE ORAL 20080924 OTC MONOGRAPH FINAL part331 WellSpring Pharmaceutical Corporation ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE; SILICON DIOXIDE 200; 24; 200; 1 mg/1; mg/1; mg/1; mg/1 65197-300_3cee597f-a68e-4e65-a077-1e09bd859fb7 65197-300 HUMAN OTC DRUG Gelusil aluminum hydroxide dried gel and magnesium hydroxide and simethicone TABLET, CHEWABLE ORAL 20120717 OTC MONOGRAPH FINAL part331 WellSpring Pharmaceutical Corporation ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE; SILICON DIOXIDE 200; 24; 200; 1 mg/1; mg/1; mg/1; mg/1 65197-310_bfdaee12-809d-49f2-a4f5-fe9dff61d63f 65197-310 HUMAN OTC DRUG Gelusil Liquid Maximum Strength aluminum hydroxide and magnesium hydroxide and simethicone LIQUID ORAL 20130801 OTC MONOGRAPH FINAL part331 WellSpring Pharmaceutical Corporation ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 65197-426_2e5f5530-e694-446c-b5d8-1bed39e0b63a 65197-426 HUMAN OTC DRUG Barriere Dimethicone CREAM TOPICAL 20100802 OTC MONOGRAPH FINAL part347 WellSpring Pharmaceutical Corporation DIMETHICONE .2 g/g 65217-0001_f94ce6c6-ed91-422b-a408-65ec7d029c72 65217-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20081021 UNAPPROVED MEDICAL GAS Frances Mahon Deaconess Hospital Home Oxygen OXYGEN 99 L/100L 65224-537_3c3ed6da-6baf-4a26-b3af-29b7236b9f5e 65224-537 HUMAN OTC DRUG Pediatex TDM TRIPROLIDINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20110429 OTC MONOGRAPH FINAL part341 Pernix Therapeutics, LLC DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 4; 10; .938 mg/mL; mg/mL; mg/mL 65224-539_5b9d57f5-e24e-4e06-8b52-f66f0b4614b6 65224-539 HUMAN OTC DRUG Pediatex TD TRIPROLIDINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20091020 OTC MONOGRAPH FINAL part341 Pernix Therapeutics, LLC PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 10; .938 mg/mL; mg/mL 65224-542_3bc43bfb-0094-46d2-8608-7b5c8f2cd54e 65224-542 HUMAN OTC DRUG Aldex AN DOXYLAMINE SUCCINATE TABLET, CHEWABLE ORAL 20100120 OTC MONOGRAPH FINAL part341 Pernix Therapeutics, LLC DOXYLAMINE SUCCINATE 5 mg/1 65224-545_3a07525b-d340-4c92-a9b8-6efdae2efb31 65224-545 HUMAN OTC DRUG Aldex CT PHENYLEPHRINE HYDROCHLORIDE and DIPHENHYDRAMINE HYDROCHLORIDE TABLET, CHEWABLE ORAL 20100120 OTC MONOGRAPH FINAL part341 Pernix Therapeutics, LLC DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 12.5; 5 mg/1; mg/1 65224-550_b0e38bac-dc1a-4f8d-a54e-184eae717bbb 65224-550 HUMAN OTC DRUG Aldex D PHENYLEPHRINE HYDROCHLORIDE and PYRILAMINE MALEATE SUSPENSION ORAL 20100601 OTC MONOGRAPH FINAL part341 Pernix Therapeutics, LLC PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE 5; 16 mg/5mL; mg/5mL 65224-557_a67e2bbc-7794-4e20-b6df-7535c0d6ab3a 65224-557 HUMAN OTC DRUG Aldex GS PSEUDOEPHEDRINE HYDROCHLORIDE and GUAIFENESIN TABLET ORAL 20110321 OTC MONOGRAPH FINAL part341 Pernix Therapeutics, LLC GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 190; 30 mg/1; mg/1 65224-560_ffbebbd4-e507-40f7-a417-4ed8cab012f1 65224-560 HUMAN OTC DRUG Aldex GS DM PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN, and DEXTROMETHORPHAN HYDROBROMIDE TABLET ORAL 20110321 OTC MONOGRAPH FINAL part341 Pernix Therapeutics, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 15; 190; 30 mg/1; mg/1; mg/1 65224-615_52db05d4-e1dc-40ff-9d06-c0a726d55760 65224-615 HUMAN OTC DRUG Z-COF 12 DM PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN, and DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20111117 OTC MONOGRAPH FINAL part341 Pernix Therapeutics DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 15; 175; 30 mg/5mL; mg/5mL; mg/5mL 65224-618_52a3a652-05a0-453a-a728-64d558741a4f 65224-618 HUMAN OTC DRUG Z-COF 1 DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, and GUAIFENESIN SUSPENSION ORAL 20110502 OTC MONOGRAPH FINAL part341 Pernix Therapeutics, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 15; 211; 30 mg/5mL; mg/5mL; mg/5mL 65224-700_5531cb78-708e-49ca-9f7d-9c7e05d7a405 65224-700 HUMAN OTC DRUG Dr. Cocoa Non-Drowsy Cough Dextromethorphan Hydrobromide LIQUID ORAL 20140201 OTC MONOGRAPH FINAL part341 Pernix Therapeutics, LLC DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg/5mL 65224-707_d1f197f8-c3fc-4e22-a576-8ad0eecb0406 65224-707 HUMAN PRESCRIPTION DRUG Omeclamox-Pak omeprazole, clarithromycin, amoxicillin KIT 20120427 NDA NDA050824 Pernix Therapeutics, LLC 65224-721_8db7ee50-e29c-41db-9174-63548f93b1b4 65224-721 HUMAN OTC DRUG Dr. Cocoa Daytime Cough and Cold Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20140201 OTC MONOGRAPH FINAL part341 Pernix Therapeutics, LLC DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL 65224-743_eecadb43-a39c-46ac-896d-658cc8f489f2 65224-743 HUMAN OTC DRUG Dr. Cocoa Nighttime Cough and Cold Diphenhydramine Hydrchloride, Phenylephrine Hydrochloride LIQUID ORAL 20140201 OTC MONOGRAPH FINAL part341 Pernix Therapeutics, LLC DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL 65224-800_46be0c08-b136-4a66-a350-82c4c5371809 65224-800 HUMAN PRESCRIPTION DRUG CEDAX ceftibuten dihydrate CAPSULE ORAL 19951220 NDA NDA050685 Pernix Therapeutics, LLC CEFTIBUTEN DIHYDRATE 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65224-802_46be0c08-b136-4a66-a350-82c4c5371809 65224-802 HUMAN PRESCRIPTION DRUG CEDAX ceftibuten dihydrate SUSPENSION ORAL 19951220 NDA NDA050686 Pernix Therapeutics, LLC CEFTIBUTEN DIHYDRATE 90 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65224-804_46be0c08-b136-4a66-a350-82c4c5371809 65224-804 HUMAN PRESCRIPTION DRUG CEDAX CEFTIBUTEN DIHYDRATE SUSPENSION ORAL 20101020 NDA NDA050686 Pernix Therapeutics, LLC CEFTIBUTEN DIHYDRATE 180 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65224-880_4e6280d3-8bdf-472e-b302-b341bdb33cdf 65224-880 HUMAN PRESCRIPTION DRUG KHEDEZLA Extended-release desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20130710 NDA NDA204683 Pernix Therapeutics DESVENLAFAXINE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 65224-890_4e6280d3-8bdf-472e-b302-b341bdb33cdf 65224-890 HUMAN PRESCRIPTION DRUG KHEDEZLA Extended-release desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20130710 NDA NDA204683 Pernix Therapeutics DESVENLAFAXINE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 65241-0001_8f5cb987-b4c0-4d82-81bb-0c148d570148 65241-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19991008 UNAPPROVED MEDICAL GAS Columbia Medical Equipment, Inc. OXYGEN 99 L/100L 65248-001_a048123c-c210-499a-85e7-bb5e85580d0c 65248-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19930101 UNAPPROVED MEDICAL GAS Genter Healthcare, Inc OXYGEN 99 L/100L 65250-266_0f8581e9-c101-43a2-a449-59dc8c890f2b 65250-266 HUMAN PRESCRIPTION DRUG EXPAREL bupivacaine INJECTION, SUSPENSION, LIPOSOMAL INFILTRATION 20120101 NDA NDA022496 Pacira Pharmaceuticals Inc. BUPIVACAINE 13.3 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 65255-409_2c7fc54b-3301-4c97-a2fa-3e20f5360b21 65255-409 HUMAN OTC DRUG Selenium sulfide SELENIUM SULFIDE SHAMPOO TOPICAL 20120208 OTC MONOGRAPH FINAL part358H Sonar Products, Inc SELENIUM SULFIDE 10 mg/mL 65257-001_3a828edd-db47-45ad-aed5-66e7f4461dcf 65257-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS AlpinAire Healthcare OXYGEN 99 L/100L 65278-007_318b93ed-05e9-4e0a-868a-f421e173bfc4 65278-007 HUMAN OTC DRUG Peter Thomas Roth CC Light to Medium Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20130222 OTC MONOGRAPH FINAL part352 June Jacobs Laboratories LLC TITANIUM DIOXIDE; ZINC OXIDE 102.6; 57.6 mg/mL; mg/mL 65282-1505_04da0c88-ef63-0712-e054-00144ff88e88 65282-1505 HUMAN PRESCRIPTION DRUG Sodium Chloride sodium chloride SOLUTION INTRAMUSCULAR; INTRAVASCULAR; SUBCUTANEOUS 20141001 UNAPPROVED DRUG OTHER Spectra Medical Devices, Inc. 65282-1510_0afa0eb2-50f7-25ff-e054-00144ff8d46c 65282-1510 HUMAN PRESCRIPTION DRUG Sodium Chloride sodium chloride SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20141001 UNAPPROVED DRUG OTHER Spectra Medical Devices, Inc. 65293-001_3ec737af-bb1b-4479-90a1-081835bae427 65293-001 HUMAN PRESCRIPTION DRUG Angiomax bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20001215 NDA NDA020873 The Medicines Company BIVALIRUDIN 250 mg/5mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] 65293-005_59683de0-4baf-11e2-933c-0002a5d5c51b 65293-005 HUMAN PRESCRIPTION DRUG Cleviprex clevidipine EMULSION INTRAVENOUS 20080915 NDA NDA022156 The Medicines Company CLEVIDIPINE .5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 65293-006_b62b217c-4f03-44cf-b038-84bbc84c9179 65293-006 PLASMA DERIVATIVE RECOTHROM Thrombin topical Recombinant KIT 20080129 BLA BLA125248 The Medicines Company 65293-007_b62b217c-4f03-44cf-b038-84bbc84c9179 65293-007 PLASMA DERIVATIVE RECOTHROM Thrombin topical Recombinant KIT 20080609 BLA BLA125248 The Medicines Company 65293-015_1fc650b0-36f7-11e4-8510-0800200c9a66 65293-015 HUMAN PRESCRIPTION DRUG Orbactiv oritavancin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140901 NDA NDA206334 The Medicines Company ORITAVANCIN 400 mg/1 65293-373_b9f66652-ab43-48f1-8da9-05c9efe6869b 65293-373 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20091118 ANDA ANDA076972 The Medicines Company ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 65293-374_b9f66652-ab43-48f1-8da9-05c9efe6869b 65293-374 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20091118 ANDA ANDA076974 The Medicines Company ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 65293-411_7ad32932-64e4-4cc5-b749-bc1a737df391 65293-411 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 The Medicines Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65293-412_7ad32932-64e4-4cc5-b749-bc1a737df391 65293-412 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000710 ANDA ANDA075154 The Medicines Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65293-413_7ad32932-64e4-4cc5-b749-bc1a737df391 65293-413 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 The Medicines Company MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65293-414_7ad32932-64e4-4cc5-b749-bc1a737df391 65293-414 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 The Medicines Company MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65293-415_7ad32932-64e4-4cc5-b749-bc1a737df391 65293-415 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 The Medicines Company MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65293-416_7ad32932-64e4-4cc5-b749-bc1a737df391 65293-416 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 The Medicines Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65293-417_7ad32932-64e4-4cc5-b749-bc1a737df391 65293-417 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 The Medicines Company MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65293-426_515789db-9048-40fe-ba91-ce61ddcd6f4e 65293-426 HUMAN PRESCRIPTION DRUG Rocuronium ROCURONIUM BROMIDE INJECTION, SOLUTION INTRAVENOUS 20091213 ANDA ANDA078651 The Medicines Company ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 65293-427_515789db-9048-40fe-ba91-ce61ddcd6f4e 65293-427 HUMAN PRESCRIPTION DRUG Rocuronium ROCURONIUM BROMIDE INJECTION, SOLUTION INTRAVENOUS 20091213 ANDA ANDA078651 The Medicines Company ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 65300-123_cbdc4154-fe7b-4911-a970-cd19df421568 65300-123 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS NASAL 20000101 UNAPPROVED MEDICAL GAS Medox Healthcare OXYGEN 210 mL/L 65300-123_e94e14cb-c46d-4329-a2e1-9765f9ca9a2a 65300-123 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS NASAL 20000101 UNAPPROVED MEDICAL GAS Medox Healthcare OXYGEN 210 mL/L 65310-002_5225be8f-6cd9-4cc6-b3e8-e9e4e13d5488 65310-002 HUMAN OTC DRUG No7 Protect and Perfect Intense Day Cream Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part352 Packaging Systems LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g 65321-011_92b3925e-8c09-41af-b7ad-6247b1ef894d 65321-011 HUMAN OTC DRUG Moisturizing Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20100225 OTC MONOGRAPH NOT FINAL part333E Rubbermaid Commercial Products LLC ALCOHOL 63 mL/100mL 65321-012_63786a03-8a36-4a4b-8344-89bbaedffce2 65321-012 HUMAN OTC DRUG TC EnrichedFoam Antibacterial Triclosan SOAP TOPICAL 20100302 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC TRICLOSAN .5 g/100mL 65321-013_cd854241-ae63-405d-bde3-a1b6fc7890b9 65321-013 HUMAN OTC DRUG TC EnrichedFoam Alcohol Hand Sanitizer Alcohol LIQUID TOPICAL 20100226 OTC MONOGRAPH NOT FINAL part333E Rubbermaid Commercial Products LLC ALCOHOL 67 mL/100mL 65321-014_afdcf979-c4c8-48d4-b446-e7fd82d35889 65321-014 HUMAN OTC DRUG TC EnrichedFoam Alcohol-Free Instant Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100226 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC BENZALKONIUM CHLORIDE .1 g/100mL 65321-017_798e7ec1-d671-456d-9447-f1a8cc816731 65321-017 HUMAN OTC DRUG TC SpraySoap Triclosan LIQUID TOPICAL 20100304 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC TRICLOSAN .5 g/100mL 65321-019_8d84a103-fbd0-4047-bc88-751b8cb30ab7 65321-019 HUMAN OTC DRUG Foaming Hand Sanitizer Alcohol LIQUID TOPICAL 20100420 OTC MONOGRAPH NOT FINAL part333 Rubbermaid Commercial Products LLC ALCOHOL 67 mL/100mL 65321-020_9d88824f-7020-4c0a-9fa3-05ed7e9cc1eb 65321-020 HUMAN OTC DRUG Foam Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC TRICLOSAN .3 g/100mL 65321-021_b850881f-86a8-40df-90fe-375d1b203383 65321-021 HUMAN OTC DRUG TC Enrichedlotion Antibacterial Hand Wash Triclosan SOAP TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC TRICLOSAN .3 g/100mL 65321-022_c968c03f-30c6-40d0-8441-8e58f16ee822 65321-022 HUMAN OTC DRUG Foam Hand Sanitizer Alcohol LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC ALCOHOL 75 mL/100mL 65321-023_c49c456d-69b3-41dd-920b-c6f351abf6fa 65321-023 HUMAN OTC DRUG TC EnrichedFoam Alcohol-Free Plus Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC BENZALKONIUM CHLORIDE .1 g/100mL 65321-024_5caedeb7-d37a-42e6-bf26-35ad3564a4f1 65321-024 HUMAN OTC DRUG Foam Hand Sanitizer Alcohol LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part333E Rubbermaid Commercial Products LLC ALCOHOL 75 mL/100mL 65321-025_17a6e144-8642-4f15-b51f-d366451d0974 65321-025 HUMAN OTC DRUG Foam Hand Sanitizer Alcohol LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC ALCOHOL 75 mL/100mL 65321-026_79d32a89-3a09-4ae1-ac0e-ce0bbaf63c72 65321-026 HUMAN OTC DRUG TC EnrichedFoam Alcohol-Free Plus Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC BENZALKONIUM CHLORIDE .1 g/100mL 65321-027_e0f55bdc-b252-409e-ab42-42dea557215c 65321-027 HUMAN OTC DRUG TC EnrichedFoam Alcohol-Free Plus Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC BENZALKONIUM CHLORIDE .1 g/100mL 65321-030_929cad42-7ccb-4a59-b326-98a6644d0cd0 65321-030 HUMAN OTC DRUG EnrichedFoam Alcohol-Free Hand Sanitizer Benzethonium Chloride LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC BENZETHONIUM CHLORIDE .1 g/100mL 65321-515_1746709c-7423-427c-9334-d673f8b6e0ac 65321-515 HUMAN OTC DRUG TC Instant Hand Sanitizer alcohol GEL TOPICAL 20110304 OTC MONOGRAPH NOT FINAL part333E Rubbermaid Commercial Products ALCOHOL 600 mL/1000mL 65342-0001_c3cdc21a-13ce-4541-8153-3a4504f4cbcc 65342-0001 HUMAN OTC DRUG laura mercier tinted moisturizer Broad Spectrum SPF 20 Sunscreen Lightweight Flawless Coverage CAMEO OCTINOXATE, OCTISALATE CREAM TOPICAL 20130206 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL 65342-0002_c4a6520f-6055-4b62-b691-075c4f930c18 65342-0002 HUMAN OTC DRUG laura mercier tinted moisturizer Broad Spectrum SPF 20 Sunscreen Lightweight Flawless Coverage NATURAL OCTINOXATE, OCTISALATE CREAM TOPICAL 20130206 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL 65342-0003_a17314eb-4862-4673-9508-d248ff64329c 65342-0003 HUMAN OTC DRUG laura mercier tinted moisturizer Broad Spectrum SPF 20 Sunscreen Lightweight Flawless Coverage OCHRE OCTINOXATE, OCTISALATE CREAM TOPICAL 20130206 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL 65342-0100_be782033-b245-4113-8cff-20f37da73ad4 65342-0100 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Creme Compact Broad Spectrum SPF 20 Sunscreen CAMEO AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20130213 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 65342-0101_59823717-8ccb-446f-ab65-069f19131aad 65342-0101 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Creme Compact Broad Spectrum SPF 20 Sunscreen NATURAL AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20130213 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 65342-0102_c7604df2-cfc2-4e66-b67d-1200df531fd2 65342-0102 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Creme Compact Broad Spectrum SPF 20 Sunscreen OCHRE AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20130213 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 65342-0940_661d09db-9d41-4ad8-b72a-19b566b5b4e5 65342-0940 HUMAN OTC DRUG Laura mercier Flawless skin Mega Moisturizer SPF-15 NORMAL COMBINATION Flawless skin Mega Moisturizer SPF-15 NORMAL COMBINATION Octinoxate ,Avobenzone CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 1; 3.75 g/50g; g/50g 65342-0945_0f54ba22-a245-4d6c-8439-b7b87da380f9 65342-0945 HUMAN OTC DRUG Laura mercier Flawless skin Mega Moisturizer SPF-15 NORMAL DRY Octinoxate ,Avobenzone CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 1; 3.75 g/50g; g/50g 65342-0947_3d68e9fd-e272-4905-983e-45675281b9e0 65342-0947 HUMAN OTC DRUG Laura mercier Moisturizer cream with SPF 15 Octinoxate ,Avobenzone CREAM TOPICAL 20090301 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 1; 3.75 g/50g; g/50g 65342-1000_c4c72469-c6b3-4925-8b8e-589bf221b398 65342-1000 HUMAN OTC DRUG laura mercier Tinted Moisturizer Creme Compact Broad Spectrum SPF 20 Sunscreen WALNUT AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20120518 OTC MONOGRAPH FINAL part352 Gurwitch Products AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 65342-1001_84d8deb0-a22a-4996-b31d-a4721ebfc2e0 65342-1001 HUMAN OTC DRUG laura mercier Tinted Moisturizer Creme Compact Broad Spectrum SPF 20 Sunscreen PORCELAIN AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20120518 OTC MONOGRAPH FINAL part352 Gurwitch Products AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 65342-1002_0928e227-8902-46b1-a92d-df796b35d954 65342-1002 HUMAN OTC DRUG laura mercier Tinted Moisturizer Creme Compact Broad Spectrum SPF 20 Sunscreen CARAMEL AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20120518 OTC MONOGRAPH FINAL part352 Gurwitch Products AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 65342-1003_a657fa3a-2589-4132-93db-22804afd0b42 65342-1003 HUMAN OTC DRUG laura mercier Tinted Moisturizer Creme Compact Broad Spectrum SPF 20 Sunscreen TAWNY AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20120518 OTC MONOGRAPH FINAL part352 Gurwitch Products AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 65342-1004_c6e0c3ba-5b78-493e-a431-2133baf9d5c8 65342-1004 HUMAN OTC DRUG laura mercier Tinted Moisturizer Creme Compact Broad Spectrum SPF 20 Sunscreen BLUSH AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20120518 OTC MONOGRAPH FINAL part352 Gurwitch Products AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 65342-1005_6a19bbf6-fb3d-40a8-9363-92a7c3290829 65342-1005 HUMAN OTC DRUG laura mercier Tinted Moisturizer Creme Compact Broad Spectrum SPF 20 Sunscreen BISQUE AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20120518 OTC MONOGRAPH FINAL part352 Gurwitch Products AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 65342-1006_1caabca7-92a8-4d62-8fde-a37f6ef5ece1 65342-1006 HUMAN OTC DRUG laura mercier Tinted Moisturizer Creme Compact Broad Spectrum SPF 20 Sunscreen MOCHA AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20120518 OTC MONOGRAPH FINAL part352 Gurwitch Products AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 65342-1007_90668a1b-e577-42bc-ab3e-6512e8ebe86d 65342-1007 HUMAN OTC DRUG laura mercier Tinted Moisturizer Creme Compact Broad Spectrum SPF 20 Sunscreen FAWN AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20120518 OTC MONOGRAPH FINAL part352 Gurwitch Products AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 65342-1008_9230fcc1-fa6e-4100-9da6-47517ddece8c 65342-1008 HUMAN OTC DRUG laura mercier Tinted Moisturizer Creme Compact Broad Spectrum SPF 20 Sunscreen TAN AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20120518 OTC MONOGRAPH FINAL part352 Gurwitch Products AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 65342-1009_2fe8f3fd-8572-433a-9dde-f8ddd6bea16f 65342-1009 HUMAN OTC DRUG laura mercier Tinted Moisturizer Creme Compact Broad Spectrum SPF 20 Sunscreen SAND AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20120518 OTC MONOGRAPH FINAL part352 Gurwitch Products AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 65342-1010_6ca27e81-1a4d-4633-9cb0-202c382458c1 65342-1010 HUMAN OTC DRUG laura mercier Tinted Moisturizer Creme Compact Broad Spectrum SPF 20 Sunscreen NUDE AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20120518 OTC MONOGRAPH FINAL part352 Gurwitch Products AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 5 g/100g; g/100g; g/100g 65342-1011_96294a38-684e-4e91-851c-7324d4254bec 65342-1011 HUMAN OTC DRUG laura mercier Tinted Moisturizer Creme Compact Broad Spectrum SPF 20 Sunscreen ALMOND AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20120518 OTC MONOGRAPH FINAL part352 Gurwitch Products AVOBENZONE; OCTISALATE; OCTOCRYLENE 3.5; 3; 5 g/100g; g/100g; g/100g 65342-1230_bb33890f-7a15-490f-816e-f4dead620a76 65342-1230 HUMAN OTC DRUG ReVive Fermitif Neck Renewal SPF 15 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Gurwitch Products, LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 2; 6; 2.7; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 65342-1377_82ffdfba-cac6-46e1-906c-005d650047a7 65342-1377 HUMAN OTC DRUG Laura mercier Tinted Moisturizer SPF-20 Nude Octinoxate ,Meradimate CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. MERADIMATE; OCTINOXATE 1.4; 3 mg/40mg; mg/40mg 65342-1378_60d26e79-1bcd-4044-bb9b-a62009ed1285 65342-1378 HUMAN OTC DRUG Laura mercier Tinted Moisturizer SPF-20 Sand Octinoxate ,Meradimate CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. MERADIMATE; OCTINOXATE 1.4; 3 mg/40mg; mg/40mg 65342-1379_f62df615-1d8f-491b-9bd3-b3dbc89e979f 65342-1379 HUMAN OTC DRUG Laura mercier Tinted Moisturizer SPF-20 Almond Octinoxate ,Meradimate CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. MERADIMATE; OCTINOXATE 1.4; 3 mg/40mg; mg/40mg 65342-1380_83fc683e-108a-4d0f-963f-90905af57ce9 65342-1380 HUMAN OTC DRUG Laura mercier Tinted Moisturizer SPF-20 Tan Octinoxate ,Meradimate CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. MERADIMATE; OCTINOXATE 1.4; 3 mg/40mg; mg/40mg 65342-1381_81ef832d-b646-4462-9c45-881084d0b18f 65342-1381 HUMAN OTC DRUG Laura mercier Tinted Moisturizer SPF-20 Porcelain Octinoxate ,Meradimate CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. MERADIMATE; OCTINOXATE 1.4; 3 mg/40mg; mg/40mg 65342-1390_77338f2a-fa61-4fc6-b9a4-9599280d94c3 65342-1390 HUMAN OTC DRUG Tinted Moisturizer SPF 20 Bisque Octinoxate ,Avobenzone CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE .8; 3 mL/40mL; mL/40mL 65342-1391_4ac44ccb-c086-42c0-8fd1-e1f277feaa63 65342-1391 HUMAN OTC DRUG Tinted Moisturizer SPF-20 Caramel Octinoxate ,Avobenzone CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE .8; 3 mL/40mL; mL/40mL 65342-1392_852ecb7c-338f-472a-bf4a-cfd8585db59b 65342-1392 HUMAN OTC DRUG Tinted Moisturizer SPF-20 Mocha Octinoxate ,Avobenzone CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE .8; 3 mL/40mL; mL/40mL 65342-1393_c7f4c10a-0b62-4586-b94f-7a64f9bf70d0 65342-1393 HUMAN OTC DRUG Tinted Moisturizer SPF-20 Golden Radiance Octinoxate ,Avobenzone CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE .8; 3 mL/40mL; mL/40mL 65342-1394_84ea2a57-bb99-4754-b8f1-91c9cfe4e907 65342-1394 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 Bronze Radiance Octinoxate ,Avobenzone CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 1; 3.75 mL/50mL; mL/50mL 65342-1395_b426e2f7-2063-45f2-8c7c-1476610ef2b4 65342-1395 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 Warm Radiance Octinoxate ,Avobenzone CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 1; 3.75 mL/50mL; mL/50mL 65342-1396_4ce59821-cfe8-4197-9cd4-e2d0c7388b08 65342-1396 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 Bare Radiance Octinoxate ,Avobenzone CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 1; 3.75 mL/50mL; mL/50mL 65342-2000_73b77026-7606-42c6-ae8a-b90aa78a6562 65342-2000 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 TAN OCTINOXATE, OCTISALATE LIQUID TOPICAL 20110421 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 5.5; 3 mL/100mL; mL/100mL 65342-2010_0b4a0bab-8b1e-4c10-98d0-3856e2836f87 65342-2010 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 ALMOND OCTINOXATE, OCTISALATE LIQUID TOPICAL 20110421 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 5.5; 3 mL/100mL; mL/100mL 65342-2020_32c95c0e-a3a4-43e6-a1ad-9a84db529e0e 65342-2020 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 SAND OCTINOXATE, OCTISALATE LIQUID TOPICAL 20110421 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 5.5; 3 mL/100mL; mL/100mL 65342-2030_2287686d-a09c-4c33-8957-ea0184a183a2 65342-2030 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 MOCHA OCTINOXATE, OCTISALATE LIQUID TOPICAL 20110428 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 5.5; 3 mL/100mL; mL/100mL 65342-2040_c0f67b35-f273-42f0-bdfb-7458cfbd2cd7 65342-2040 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 BISQUE OCTINOXATE, OCTISALATE LIQUID TOPICAL 20110428 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 5.5; 3 mL/100mL; mL/100mL 65342-2050_eebc926d-63af-4a90-895f-bc4db1fc3f84 65342-2050 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 PORCELAIN OCTINOXATE, OCTISALATE LIQUID TOPICAL 20110428 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 5.5; 3 mL/100mL; mL/100mL 65342-2060_5626297a-670f-4feb-ae77-e89761bc23ae 65342-2060 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 WALNUT OCTINOXATE, OCTISALATE LIQUID TOPICAL 20110421 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 5.5; 3 mL/100mL; mL/100mL 65342-2070_f1527c02-7c22-4961-a533-9d88b73713c1 65342-2070 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 FAWN OCTINOXATE, OCTISALATE LIQUID TOPICAL 20110428 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 5.5; 3 mL/100mL; mL/100mL 65342-2080_77f4eb9e-fdb6-4395-bbec-2036f871f510 65342-2080 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 CARAMEL OCTINOXATE, OCTISALATE LIQUID TOPICAL 20110428 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 5.5; 3 mL/100mL; mL/100mL 65342-2090_85fbc53a-403f-41dd-997e-d641a5a439c2 65342-2090 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 NUDE OCTINOXATE, OCTISALATE LIQUID TOPICAL 20110428 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 5.5; 3 mL/100mL; mL/100mL 65342-2100_456cb1ce-924f-4adf-9fc9-095c1c501222 65342-2100 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 TAWNY OCTINOXATE, OCTISALATE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. OCTINOXATE; OCTISALATE 5.5; 3 mL/100mL; mL/100mL 65342-2101_a9afe786-9c76-45dd-b202-3cf5df7433b9 65342-2101 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 BLUSH OCTINOXATE, OCTISALATE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. OCTINOXATE; OCTISALATE 5.5; 3 mL/100mL; mL/100mL 65342-2320_c71c48ce-7c26-42c4-a736-d99536980035 65342-2320 HUMAN OTC DRUG Laura mercier Tinted Moisturizer SPF-20 Walnut SPF-20 Walnut Octinoxate ,Meradimate CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. MERADIMATE; OCTINOXATE 1.4; 3 mg/40mg; mg/40mg 65342-2340_19e5981b-7977-4d66-9006-0b6ec18e4433 65342-2340 HUMAN OTC DRUG Laura Mercier Flawless Skin Daily Face Shield SPF 40 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110421 OTC MONOGRAPH FINAL part352 Gurwitch Products, LLC OCTINOXATE; TITANIUM DIOXIDE 7.5; 5 mL/100mL; mL/100mL 65342-2963_bb09a843-bba9-4c61-ad28-afae80a35f31 65342-2963 HUMAN OTC DRUG Laura mercier Tinted Moisturizer SPF-20 Fawn Octinoxate ,Meradimate CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. MERADIMATE; OCTINOXATE 1.4; 3 mg/40mg; mg/40mg 65342-7001_a9fe4c82-3c58-49de-9016-bf16d1d616c1 65342-7001 HUMAN OTC DRUG Laura Mercier Foundation Primer Protect SPF 30 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 30; 73; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL 65342-7003_a9fe4c82-3c58-49de-9016-bf16d1d616c1 65342-7003 HUMAN OTC DRUG Laura Mercier Foundation Primer Protect SPF 30 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 30; 73; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL 65342-7005_a9fe4c82-3c58-49de-9016-bf16d1d616c1 65342-7005 HUMAN OTC DRUG Laura Mercier Foundation Primer Protect SPF 30 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 30; 73; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL 65360-1073_33aab730-8188-4b53-9bc2-f9e0230d1f6a 65360-1073 HUMAN PRESCRIPTION DRUG Liquid Oxygen Liquid Oxygen GAS RESPIRATORY (INHALATION) 19990102 UNAPPROVED MEDICAL GAS Community Home Health Services OXYGEN 995 mL/L 65364-100_d23cbd27-c568-4c8d-b5d8-036fd8098175 65364-100 HUMAN OTC DRUG Kiss My Face - Oat Protein Complex SPF 18 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part352 Kiss My Face Corp. TITANIUM DIOXIDE; ZINC OXIDE 4.25; 3.75 mL/100mL; mL/100mL 65364-110_a4c44c34-d125-4be3-bfbe-02d9f75458bd 65364-110 HUMAN OTC DRUG Kiss My Face - Oat Protein Complex SPF 30 OCTINOXATE, OCTISALATE, ZINC OXIDE LOTION TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part352 Kiss My Face Corp. OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 3; 4.5 mL/100mL; mL/100mL; mL/100mL 65364-120_d555d32c-14d2-4791-8b1b-45189d7ca522 65364-120 HUMAN OTC DRUG Kiss My Face - Face Factor SPF 30 OCTINOXATE, OCTISALATE, ZINC OXIDE LOTION TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part352 Kiss My Face Corp. OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 3; 3 mL/100mL; mL/100mL; mL/100mL 65365-001_42756198-0a9e-427a-883a-4f64f8488327 65365-001 HUMAN OTC DRUG HAND SANITIZING GREEN APPLE ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sigan Industries ALCOHOL 62 mL/100mL 65365-002_e4752d2c-1463-4940-93f8-6af8c91d2f60 65365-002 HUMAN OTC DRUG HAND SANITIZING MANDARIN ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sigan Industries ALCOHOL 62 mg/100mL 65365-003_13186e87-9f79-494e-997d-9929cf7a3719 65365-003 HUMAN OTC DRUG HAND SANITIZING BLUEBERRY ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sigan Industries ALCOHOL 62 mg/100mL 65365-004_8f3ae28f-c7ac-46bc-80fc-a5256cf20e3b 65365-004 HUMAN OTC DRUG HAND SANITIZING STRAWBERRY ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sigan Industries ALCOHOL 62 mL/100mL 65365-005_7cf8c2f5-fe9c-4366-869c-582ca4c4b174 65365-005 HUMAN OTC DRUG HAND SANITIZING UNSCENTED ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sigan Industries ALCOHOL 62 mg/100mL 65365-006_e35a9159-ae6a-484f-81a8-3c19eeae52cf 65365-006 HUMAN OTC DRUG HAND SANITIZING SPECIAL TEACHER GREEN APPLE ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sigan Industries ALCOHOL 62 mg/100mL 65365-007_779a0099-2dc6-4f95-84ac-13774e829167 65365-007 HUMAN OTC DRUG HAND SANITIZING TEACHERS RULE MANDARIN ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sigan Industries ALCOHOL 62 mg/mL 65365-008_1044980e-7348-474f-ba4c-8c3c78801f01 65365-008 HUMAN OTC DRUG HAND SANITIZING A PLUS TEACHER UNSCENTED ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sigan Industries ALCOHOL 62 mg/100mL 65371-025_a248570a-8143-440d-8395-fc2be4548b08 65371-025 HUMAN OTC DRUG BB ANTI-FATIGUE ABSOLUTE SPF 25 HOMOSALATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 ORLANE S.A. HOMOSALATE; OCTISALATE; OXYBENZONE 90; 45; 30 mg/mL; mg/mL; mg/mL 65371-030_b9041dc8-11d3-4251-8829-cf05b03fa911 65371-030 HUMAN OTC DRUG Extreme Anti-Wrinkle Care SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 ORLANE, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 103; 51.5; 103; 51.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 65373-100_e96c0c50-9c4d-4dc3-9eb8-481cabfc42fa 65373-100 HUMAN OTC DRUG Tineacide Physician Formula UNDECYLENIC ACID CREAM TOPICAL 19950101 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 13 g/100g 65373-400_59926da3-7841-4635-b65c-7e48cee11256 65373-400 HUMAN OTC DRUG Ortho-Nesic Menthol GEL TOPICAL 19950101 OTC MONOGRAPH FINAL part341 Blaine Labs Inc. CAMPHOR (SYNTHETIC); MENTHOL .2; 3.5 g/100g; g/100g 65373-401_37672821-f011-4436-be93-a9c8832e26bf 65373-401 HUMAN OTC DRUG Ortho-Nesic With Capsaicin Menthol GEL TOPICAL 19950101 OTC MONOGRAPH FINAL part341 Blaine Labs Inc. CAMPHOR (SYNTHETIC); MENTHOL .2; 3.5 g/100g; g/100g 65373-500_e96c0c50-9c4d-4dc3-9eb8-481cabfc42fa 65373-500 HUMAN OTC DRUG Tineacide Undecylenic Acid CREAM TOPICAL 19950101 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 10 g/100g 65386-0001_f3dae8f7-d5e4-4049-9551-a8a6b8ae57ca 65386-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990701 UNAPPROVED MEDICAL GAS Advacare Home Services OXYGEN 99 L/100L 65402-0001_302c38e7-bcd2-4a74-a7b7-468b1d85d603 65402-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19991207 UNAPPROVED MEDICAL GAS Danes Welding Supplies Inc. OXYGEN 99 L/100L 65435-0116_fdb6b8cf-f655-47b6-8052-623a40d2ff2a 65435-0116 HUMAN OTC DRUG Safe Sea Sunscreen With Jellyfish Sting Protective SPF 15 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20111112 OTC MONOGRAPH FINAL part352 Nidaria Technology Ltd. OCTINOXATE; ZINC OXIDE 7.5; 2 mL/100mL; mL/100mL 65435-0131_f324182e-5d71-44b8-af54-6970728da556 65435-0131 HUMAN OTC DRUG Safe Sea Sunscreen With Jellyfish Sting Protective SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20111112 OTC MONOGRAPH FINAL part352 Nidaria Technology Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 5; 3; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 65435-0133_2705bdfb-5d32-453e-8a0a-f824a57c5915 65435-0133 HUMAN OTC DRUG Safe Sea For Kids Sunscreen With Jellyfish Sting Protective SPF 30 Plus OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20111112 OTC MONOGRAPH FINAL part352 Nidaria Technology Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 5; 3; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 65435-0151_e3d85083-3155-48c9-817c-74121784b505 65435-0151 HUMAN OTC DRUG Safe Sea Sunscreen With Jellyfish Sting Protective SPF 50 OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20111112 OTC MONOGRAPH FINAL part352 Nidaria Technology Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 2; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 65437-035_202d0e83-dbbd-48ab-b66a-920c68170dde 65437-035 HUMAN OTC DRUG SENNA LEAF and DOCUSATE SODIUM SENNA LEAF and DOCUSATE SODIUM TABLET, FILM COATED ORAL 20100401 OTC MONOGRAPH NOT FINAL part334 HIMPRIT PHARMACHEM PVT LTD DOCUSATE SODIUM; SENNA LEAF 50; 8.6 mg/1; mg/1 65437-036_34dbcd2a-11a4-4688-8efb-07e90a503c95 65437-036 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20100301 OTC MONOGRAPH FINAL part341 HIMPRIT PHARMACHEM PVT LTD DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 65437-037_8841b9a3-1a06-4828-9eef-bec7331b6206 65437-037 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20100301 OTC MONOGRAPH FINAL part338 HIMPRIT PHARMACHEM PVT LTD DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 65437-038_d2b2b80e-0e38-41bd-8e19-924863fbd11c 65437-038 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, FILM COATED ORAL 20100301 OTC MONOGRAPH FINAL part341 HIMPRIT PHARMACHEM PVT LTD ASPIRIN 325 mg/1 65437-040_dfdf9b9f-ecc3-4c25-8a5d-c744a9bb6651 65437-040 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET, FILM COATED ORAL 20100701 OTC MONOGRAPH FINAL part343 HIMPRIT PHARMACHEM PVT LTD ACETAMINOPHEN 500 mg/1 65437-041_13d391cd-6737-4d5d-a811-4cd602ec0013 65437-041 HUMAN OTC DRUG ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN and DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20100701 OTC MONOGRAPH NOT FINAL part343 HIMPRIT PHARMACHEM PVT LTD ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 65437-087_f06df412-c097-4acc-a2d3-277aaeb3b17a 65437-087 HUMAN OTC DRUG SENNA SENNA TABLET, FILM COATED ORAL 20091120 OTC MONOGRAPH FINAL part334 HIMPRIT PHARMACHEM PVT LTD SENNA 8.6 mg/1 65447-050_0ab6b7a0-0a50-4c11-bfbc-46ab66be5d28 65447-050 HUMAN OTC DRUG Cellular Day Defense Firming SPF 25 zinc oxide, oxybenzone, and octinoxate CREAM TOPICAL 20111015 OTC MONOGRAPH NOT FINAL part352 Aloette Cosmetics Inc. OCTINOXATE; OXYBENZONE; ZINC OXIDE 7.5; 3; 5 g/100g; g/100g; g/100g 65460-3111_a59b2ac2-a423-4f50-8b27-dd471859c51e 65460-3111 HUMAN OTC DRUG antimicrobial hand wipe Alcohol CLOTH TOPICAL 20091130 OTC MONOGRAPH FINAL part333 SAS Safety ALCOHOL .6 g/1 65465-0001_41764a77-d6d6-44f9-b355-ca3fdaccbf61 65465-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030501 UNAPPROVED MEDICAL GAS Apex of St. Peters OXYGEN 99 L/100L 65468-001_264d63e6-4329-4440-af08-f26cdd5a8198 65468-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Valley Medical Shoppe OXYGEN 99 L/100L 65483-093_6008addc-7f8e-45bb-8aec-54dd54a788ac 65483-093 HUMAN PRESCRIPTION DRUG RIDAURA auranofin CAPSULE ORAL 19850424 NDA NDA018689 Prometheus Laboratories Inc. AURANOFIN 3 mg/1 65483-116_eaf657c3-42f0-4170-b187-9197d7194cd5 65483-116 HUMAN PRESCRIPTION DRUG Proleukin aldesleukin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19920505 BLA BLA103293 Prometheus Laboratories Inc. ALDESLEUKIN 1.1 mg/mL Increased Lymphocyte Activation [PE],Increased Lymphocyte Cell Production [PE],Interleukin-2 [Chemical/Ingredient],Lymphocyte Growth Factor [EPC] 65483-391_8d2825c1-c676-4a48-bb9f-e0e2b7cc9ee1 65483-391 HUMAN PRESCRIPTION DRUG Trandate labetalol hydrochloride TABLET ORAL 19840531 NDA NDA018716 Prometheus Laboratories Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65483-392_8d2825c1-c676-4a48-bb9f-e0e2b7cc9ee1 65483-392 HUMAN PRESCRIPTION DRUG Trandate labetalol hydrochloride TABLET ORAL 19840531 NDA NDA018716 Prometheus Laboratories Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65483-393_8d2825c1-c676-4a48-bb9f-e0e2b7cc9ee1 65483-393 HUMAN PRESCRIPTION DRUG Trandate labetalol hydrochloride TABLET ORAL 19840531 NDA NDA018716 Prometheus Laboratories Inc. LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65483-590_1900ba0c-ab08-41f3-b542-4d79dde14cd6 65483-590 HUMAN PRESCRIPTION DRUG IMURAN azathioprine TABLET ORAL 19680320 NDA NDA016324 Prometheus Laboratories Inc. AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 65483-702_c99a57a5-655a-4ded-9397-eb7881a3e670 65483-702 HUMAN PRESCRIPTION DRUG ENTOCORT EC Budesonide CAPSULE ORAL 20011029 NDA NDA021324 Prometheus Laboratories Inc BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 65483-894_66cf41ae-b5a3-49ad-8134-de50360b1040 65483-894 HUMAN PRESCRIPTION DRUG LOTRONEX alosetron hydrochloride TABLET ORAL 20090209 NDA NDA021107 Prometheus Laboratories Inc. ALOSETRON HYDROCHLORIDE .5 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 65483-895_66cf41ae-b5a3-49ad-8134-de50360b1040 65483-895 HUMAN PRESCRIPTION DRUG LOTRONEX alosetron hydrochloride TABLET ORAL 20090209 NDA NDA021107 Prometheus Laboratories Inc. ALOSETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 65483-991_cec6bc7a-f20a-4216-8eb8-67fb1ba15ec7 65483-991 HUMAN PRESCRIPTION DRUG ZYLOPRIM allopurinol TABLET ORAL 19660819 NDA NDA016084 Prometheus Laboratories Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 65483-993_cec6bc7a-f20a-4216-8eb8-67fb1ba15ec7 65483-993 HUMAN PRESCRIPTION DRUG ZYLOPRIM allopurinol TABLET ORAL 19660819 NDA NDA016084 Prometheus Laboratories Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 65517-0001_15e7dc14-3948-485e-8eca-43b44957dcc7 65517-0001 HUMAN OTC DRUG Dukal Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20100501 OTC MONOGRAPH FINAL part333 Dukal Corporation ISOPROPYL ALCOHOL .7 mL/mL 65517-0001_8bfa4ab0-9b92-4df1-8291-91c4bdf7e6ce 65517-0001 HUMAN OTC DRUG Dukal Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20100501 OTC MONOGRAPH FINAL part333 Dukal Corporation ISOPROPYL ALCOHOL .7 mL/mL 65517-0002_31b45754-6dd1-4e84-8c2d-595464faf344 65517-0002 HUMAN OTC DRUG Dukal Sterile Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20000101 OTC MONOGRAPH FINAL part333 Dukal Corporation ISOPROPYL ALCOHOL .7 mL/mL 65517-0002_8a28662e-463b-4d4d-972c-70ba441d4c11 65517-0002 HUMAN OTC DRUG Dukal Sterile Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20000101 OTC MONOGRAPH FINAL part333 Dukal Corporation ISOPROPYL ALCOHOL .7 mL/mL 65517-0003_9c2999bd-af6f-4158-9143-75bd52edfb59 65517-0003 HUMAN OTC DRUG BZK Swab BENZALKONIUM CHLORIDE SWAB TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333A DUKAL CORPORATION BENZALKONIUM CHLORIDE .00133 mL/mL 65517-0004_8d26895e-f8a2-4a12-9eb3-a52b2e1c2f58 65517-0004 HUMAN OTC DRUG BZK Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333A DUKAL CORPORATION BENZALKONIUM CHLORIDE .00186 mL/1.4mL 65517-0005_2c6f0ec3-d960-4568-8645-fd5811aadc9f 65517-0005 HUMAN OTC DRUG DUKAL STING RELIEF PAD BENZOCAINE SWAB TOPICAL 20100601 OTC MONOGRAPH FINAL part348 Dukal Corporation BENZOCAINE; ISOPROPYL ALCOHOL 60; .6 mg/mL; mL/mL 65517-0006_06a2d610-3da1-441f-844d-68de3084c9f7 65517-0006 HUMAN OTC DRUG Dukal Sterile Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20000101 OTC MONOGRAPH FINAL part333A Dukal Corporation ISOPROPYL ALCOHOL .7 mL/mL 65517-0008_8a5253c8-1929-491d-aebc-a863452a4e89 65517-0008 HUMAN OTC DRUG Scrub Solution POVIDONE-IODINE SOLUTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Dukal Corporation POVIDONE-IODINE .9 mL/100mL 65517-0009_853a4112-f20f-4bea-b94c-91aa5d5cf1e9 65517-0009 HUMAN OTC DRUG Prep Solution POVIDONE-IODINE SOLUTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Dukal Corporation POVIDONE-IODINE 1.2 mL/100mL 65517-0010_8da692fb-6e8b-4550-ae94-c58b58c718c8 65517-0010 HUMAN OTC DRUG DUKAL POVIDONE-IODINE SWABSTICK POVIDONE-IODINE GEL TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Dukal Corporation POVIDONE-IODINE 1.2 mL/100mL 65517-0011_b371219d-0e73-4f27-ad26-1b8ba2fa3090 65517-0011 HUMAN OTC DRUG OB Cleansing Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part310.545 Dukal Corporation BENZALKONIUM CHLORIDE .0021 mL/1.4mL 65517-0012_a50cb3d8-b642-402f-8701-b4abde91965e 65517-0012 HUMAN OTC DRUG PHYSICIANS CARE STING RELIEF PAD BENZOCAINE SWAB TOPICAL 20100601 OTC MONOGRAPH FINAL part348 Dukal Corporation BENZOCAINE; ISOPROPYL ALCOHOL .06; .6 mL/mL; mL/mL 65517-0013_80d20f92-8fa0-4f72-88ee-f800005963ee 65517-0013 HUMAN OTC DRUG Acme Home/Office/Auto Kit First Aid Kit KIT 20100501 OTC MONOGRAPH FINAL part333 Dukal Corporation 65517-0014_e643840c-bc52-4280-ac01-b83fc6778d42 65517-0014 HUMAN OTC DRUG OB Cleansing Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Dukal Corporation BENZALKONIUM CHLORIDE .0021 mL/1.4mL 65517-0015_7dad176d-bf6f-4c68-83ae-1e8706709f2c 65517-0015 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20100601 OTC MONOGRAPH FINAL part333 Dukal Corporation ISOPROPYL ALCOHOL .7 mL/mL 65517-0016_7add14f5-e4a1-4f5a-9c5e-35213c43aaf4 65517-0016 HUMAN OTC DRUG Quick n Clean Antiseptic Hand Wipe Benzalkonium Chloride SWAB TOPICAL 20100601 OTC MONOGRAPH FINAL part333 Dukal Corporation BENZALKONIUM CHLORIDE .00186 mL/1.4mL 65517-0026_51e97204-8280-4a48-be06-345718268412 65517-0026 HUMAN OTC DRUG Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20120518 OTC MONOGRAPH FINAL part333A Dukal Corporation ISOPROPYL ALCOHOL 70 mL/100mL 65517-0027_abad83f9-9447-4782-befb-288f120e68a9 65517-0027 HUMAN OTC DRUG PVP Prep Povidone-Iodine SOLUTION TOPICAL 20120518 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation POVIDONE-IODINE 10 mL/100mL 65517-0028_3d206a45-28fa-4fe9-80d3-206ba9dbac8f 65517-0028 HUMAN OTC DRUG PVP Scrub Povidone-Iodine SOLUTION TOPICAL 20120518 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation POVIDONE-IODINE 8 mL/100mL 65517-0029_13e530a7-6c1f-4738-bd31-4bd63f22960a 65517-0029 HUMAN OTC DRUG PVP Prep Pad Povidone-Iodine SOLUTION TOPICAL 20120518 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation POVIDONE-IODINE 10 mL/100mL 65517-1000_01e3aa3f-7982-42e3-be41-b67131c9ea43 65517-1000 HUMAN OTC DRUG Dawnmist Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20120924 OTC MONOGRAPH FINAL part355 Dukal Corporation SODIUM MONOFLUOROPHOSPHATE .76 g/100g 65517-1001_da82961d-f51d-426e-a9a2-87339eec7d6e 65517-1001 HUMAN OTC DRUG DawnMist Antibacterial TRICLOSAN GEL TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation TRICLOSAN 3 mg/mL 65517-1002_c06be3b9-76be-45d5-a5c6-10849a44a4ed 65517-1002 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130110 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 79 mg/mL 65517-1003_88ae466f-bf65-4c0b-8898-e56d1d25cb8a 65517-1003 HUMAN OTC DRUG DawMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130110 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 78 mg/mL 65517-1004_d31778d1-d831-47f1-b22a-292e0aa27205 65517-1004 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130110 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 45 mg/mL 65517-1005_2b04f2bc-8fe5-4095-989f-377373c3f0c3 65517-1005 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130110 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 45 mg/mL 65517-1006_69c32aa0-b13f-4c1a-8092-5e92109df943 65517-1006 HUMAN OTC DRUG Dawnmist Deodorant TRICLOSAN SOAP TOPICAL 20130108 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation TRICLOSAN .25 g/100g 65517-1007_b7c117bb-5422-4b01-8bcd-707dbbc6461f 65517-1007 HUMAN OTC DRUG DawnMist Alcohol Hand Sanitizer ALCOHOL GEL TOPICAL 20130114 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation ALCOHOL 700 mg/mL 65517-1008_1242f838-95b1-4ad2-9fe5-e7b177165f66 65517-1008 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130110 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 45 mg/mL 65517-1009_f3fbcdcc-69f8-4229-ac8a-329d30308913 65517-1009 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130110 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 45 mg/mL 65517-1010_63d08b13-000c-447e-8051-974f39f16868 65517-1010 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130110 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 78 mg/mL 65517-1011_ed4d5130-6313-4a90-ae57-e0304f0bcfd0 65517-1011 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130110 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 78 mg/mL 65517-1012_7ead203c-98a5-450a-aa65-44d5d8f7b4e1 65517-1012 HUMAN OTC DRUG DawnMist Antibacterial TRICLOSAN GEL TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation TRICLOSAN 3 mg/mL 65517-1013_fa0d9c17-3e9a-486d-81d5-a041770ed740 65517-1013 HUMAN OTC DRUG Dawnmist Deodorant TRICLOSAN SOAP TOPICAL 20130108 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation TRICLOSAN .2 g/100g 65517-1014_79426272-32ca-4127-96e3-21a43bb9b451 65517-1014 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20130502 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 45 mg/mL 65517-1015_7f17de5d-cacd-4466-9293-7d3d3041a59c 65517-1015 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20130502 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 150 mg/mL 65517-1016_aa4d2677-6a8e-48ad-bd24-1142040f7a52 65517-1016 HUMAN OTC DRUG DawnMist Hypoallergenic 100 Percent Pure Petroleum PETROLATUM JELLY TOPICAL 20130502 OTC MONOGRAPH FINAL part347 Dukal Corporation PETROLATUM 100 g/100g 65517-1017_cb033ae5-1f66-4182-9c0c-3a41e0597c5c 65517-1017 HUMAN OTC DRUG DawnMist Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20130606 OTC MONOGRAPH FINAL part355 Dukal Corporation SODIUM MONOFLUOROPHOSPHATE .76 g/100g 65517-1018_d5f76f24-05fe-44df-8cfe-4ffa7e6c2dd4 65517-1018 HUMAN OTC DRUG DawnMist Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20130606 OTC MONOGRAPH FINAL part355 Dukal Corporation SODIUM MONOFLUOROPHOSPHATE .76 g/100g 65517-1019_5a55cc5d-c039-4687-8738-55b0b78d6d5f 65517-1019 HUMAN OTC DRUG DawnMist Barrier Dimethicone CREAM TOPICAL 20130919 OTC MONOGRAPH FINAL part347 DUKAL Corporation DIMETHICONE .2 g/100g 65517-2000_5ca1d990-9091-4c26-87d2-d5afc49ec0d3 65517-2000 HUMAN OTC DRUG Sodium fluoride Toothpaste CREAM ORAL 20131113 OTC MONOGRAPH FINAL part355 DUKAL CORPORATION SODIUM FLUORIDE .22 g/100g 65517-2002_a3ca91a8-7786-48c9-ade6-8ea6a42942e0 65517-2002 HUMAN OTC DRUG DUKAL Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20140501 OTC MONOGRAPH FINAL part344 DUKAL Corporation ISOPROPYL ALCOHOL .7 g/mL 65517-2003_2488648c-97b4-40c0-b655-ab6dee7431a9 65517-2003 HUMAN OTC DRUG Dukal Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20140617 OTC MONOGRAPH FINAL part344 Dukal Corporation ISOPROPYL ALCOHOL .7 g/mL 65517-2017_f4fc92a0-26cf-4b51-ac0a-e33bf70ee966 65517-2017 HUMAN OTC DRUG DAWNMIST FLUORIDE SODIUM FLUORIDE PASTE DENTAL 20140117 OTC MONOGRAPH FINAL part355 DUKAL Corporation SODIUM FLUORIDE .22 g/100g 65517-2018_b58c00b4-af53-4999-abae-902d74603532 65517-2018 HUMAN OTC DRUG DawnMist Fluoride Sodium Fluoride PASTE DENTAL 20140130 OTC MONOGRAPH FINAL part355 Dukal Corporation SODIUM FLUORIDE .76 g/100g 65517-2020_cee47fec-a5d2-4b8c-9780-296a0a43b2b4 65517-2020 HUMAN OTC DRUG Dawnmist Petroleum Petrolatum JELLY TOPICAL 20141020 OTC MONOGRAPH FINAL part347 Dukal Corp PETROLATUM 100 g/100g 65517-2021_fe50ed32-a69f-4a68-a9bb-a2b6683671aa 65517-2021 HUMAN OTC DRUG Dawnmist Moisture Barrier Petrolatum JELLY TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Dukal Corp PETROLATUM 98.3 g/100g 65556-398_ccfed2e6-68df-4dcd-bb62-91de50e4485e 65556-398 HUMAN OTC DRUG Clearly Confident Miconazole Nitrate CREAM TOPICAL 20131217 OTC MONOGRAPH FINAL part333C Ganeden Biotech, Inc. MICONAZOLE NITRATE 20 mg/g 65567-001_1aebaade-648c-4629-9fe6-6f1173b7e9b7 65567-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000420 UNAPPROVED MEDICAL GAS Central Montana Medical Center Home Oxgen OXYGEN 990 mL/L 65573-001_57ddfcf3-58cd-457a-826a-9473e3697fe4 65573-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000101 UNAPPROVED MEDICAL GAS Home Equipment Assoc Inc dba Healthwise OXYGEN 990 mL/L 65580-251_bdd8cfa6-e430-410e-ab6c-7efdcb9b33a0 65580-251 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate prednisolone sodium phosphate SOLUTION ORAL 20020211 NDA NDA019157 Upstate Pharma, LLC PREDNISOLONE SODIUM PHOSPHATE 6.7 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 65580-301_8d658870-9173-4807-81be-0e247d3189e8 65580-301 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080930 NDA NDA022104 Upstate Pharma, LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65580-302_8d658870-9173-4807-81be-0e247d3189e8 65580-302 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081010 NDA NDA022104 Upstate Pharma, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65580-303_8d658870-9173-4807-81be-0e247d3189e8 65580-303 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081010 NDA NDA022104 Upstate Pharma, LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65580-304_8d658870-9173-4807-81be-0e247d3189e8 65580-304 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081017 NDA NDA022104 Upstate Pharma, LLC VENLAFAXINE HYDROCHLORIDE 225 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65580-530_0ceb1aef-f388-48a0-86f4-5deb98c23011 65580-530 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 20141101 ANDA ANDA085799 Upstate Pharma, LLC METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 65580-531_0ceb1aef-f388-48a0-86f4-5deb98c23011 65580-531 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 20141101 ANDA ANDA086429 Upstate Pharma, LLC METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 65580-532_0ceb1aef-f388-48a0-86f4-5deb98c23011 65580-532 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 20141101 ANDA ANDA086428 Upstate Pharma, LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 65580-594_5b5a7685-72d4-41e8-8f04-13410a6e648b 65580-594 HUMAN PRESCRIPTION DRUG Metadate ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA089601 Upstate Pharma, LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 65580-643_300ea7e5-489b-4878-af45-136d14f560ff 65580-643 HUMAN PRESCRIPTION DRUG metolazone metolazone TABLET ORAL 19731127 NDA AUTHORIZED GENERIC NDA017386 Upstate Pharma, LLC METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 65580-644_300ea7e5-489b-4878-af45-136d14f560ff 65580-644 HUMAN PRESCRIPTION DRUG metolazone metolazone TABLET ORAL 19731127 NDA AUTHORIZED GENERIC NDA017386 Upstate Pharma, LLC METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 65580-645_300ea7e5-489b-4878-af45-136d14f560ff 65580-645 HUMAN PRESCRIPTION DRUG metolazone metolazone TABLET ORAL 19731127 NDA AUTHORIZED GENERIC NDA017386 Upstate Pharma, LLC METOLAZONE 10 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 65582-100_e86a7f26-5f62-4509-9d09-22732b63b3cd 65582-100 HUMAN OTC DRUG Quintessence Q-Sunshade Leave In Hair Conditioner and Scalp Protectant SPF 30 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part352 International Cosmeceuticals, Inc OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 5; 1 mL/100mL; mL/100mL; mL/100mL 65585-373_d16177dc-cba9-4ed0-95ad-16f034186ef5 65585-373 HUMAN OTC DRUG WhiskCare 373 Alcohol SOAP TOPICAL 20080117 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. ALCOHOL 650 mL/L 65585-375_d365ca5d-4f37-440e-94a1-7ac7b7b7a6e2 65585-375 HUMAN OTC DRUG WhiskCare 375 Alcohol GEL TOPICAL 20050601 OTC MONOGRAPH NOT FINAL part333A Whisk Products, Inc. ALCOHOL 600 mL/L 65585-376_2500179f-23a1-4aba-92c7-2a87014326d9 65585-376 HUMAN OTC DRUG WhiskCare 375 Fragrance Free Instant Hand Sanitizer GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Whisk Products, Inc. ALCOHOL 600 mL/L 65585-387_dbceb9c7-7962-40b2-80c2-b756a4efc326 65585-387 HUMAN OTC DRUG WhiskCare 387 Triclosan SOAP TOPICAL 20070214 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. TRICLOSAN 3 mg/mL 65585-480_ffd68068-bb89-4aaa-8f5b-21a335f1aa3f 65585-480 HUMAN OTC DRUG Alpha E-3 Alcohol SPRAY TOPICAL 20051219 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. ALCOHOL 600 mL/L 65585-494_03ee4490-3e18-4d59-86fb-27a94d8e3995 65585-494 HUMAN OTC DRUG Chem Clean Antibacterial Hand Chloroxylenol SOAP TOPICAL 20080103 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. CHLOROXYLENOL .75 g/100g 65585-495_16d1c0ca-1266-4949-8b6d-c28a189813ab 65585-495 HUMAN OTC DRUG Alpha E-2 Benzalkonium Chloride SOAP TOPICAL 20080121 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 25 mg/mL 65585-497_8bc1f230-d929-42de-8ed3-5432cd6c8fbe 65585-497 HUMAN OTC DRUG Alpha Alcohol Free Foaming Instant Hand Sanitizer Benzalkonium Chloride SOAP TOPICAL 20090526 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 1 mg/mL 65585-503_330325b3-3bed-43f0-88dd-21c36803ea5d 65585-503 HUMAN OTC DRUG AMP Instant Hand Sanitizer Hand Sanitizer SOAP TOPICAL 20091209 OTC MONOGRAPH NOT FINAL part333 Whisk Products, Inc. ALCOHOL 600 mL/L 65585-504_860908e6-7b52-4a09-8e07-6aa809f41076 65585-504 HUMAN OTC DRUG Jade Antibacterial Hand Soap SOAP TOPICAL 20100223 OTC MONOGRAPH NOT FINAL part333 Whisk Products, Inc. TRICLOSAN .3 g/100g 65585-508_f74366ee-ac69-4fd2-8e6b-e01cce16ee68 65585-508 HUMAN OTC DRUG SMJ Antibacterial Hand Chloroxylenol SOAP TOPICAL 20120105 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. CHLOROXYLENOL .75 g/100g 65585-509_127fa410-10d5-48a9-9805-f70aaa9265dd 65585-509 HUMAN OTC DRUG WhiskCare 357 Benzalkonium Chloride SOAP TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL 65585-510_a86211b1-994d-4b9e-995c-2a58bffedd25 65585-510 HUMAN OTC DRUG Alpha Foaming E-2 Benzalkonium Chloride SOAP TOPICAL 20121022 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL 65585-511_6e7c77e7-a1a7-45ce-969a-03c06455d0ab 65585-511 HUMAN OTC DRUG Hand-Giene E-2 Benzalkonium Chloride SOAP TOPICAL 20121106 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL 65585-512_c39afd34-2977-4292-b55f-5ce28eb9e9d9 65585-512 HUMAN OTC DRUG Safe Hands U-357 Benzalkonium Chloride SOAP TOPICAL 20130626 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL 65585-515_189d8ecd-73c5-427c-8578-d1caf82340f1 65585-515 HUMAN OTC DRUG North Woods Germ Stuff Benzalkonium Chloride SOAP TOPICAL 20140702 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 25 mg/mL 65585-568_b8f58d10-d78c-4e1e-8884-8b2b2ebca7cb 65585-568 HUMAN OTC DRUG WhiskCare 367 Antibacterial Hand Soap SOAP TOPICAL 20071206 OTC MONOGRAPH NOT FINAL part333 Whisk Products, Inc. CHLOROXYLENOL .75 g/100g 65585-577_e8d0b80f-e524-43c1-b368-fb81b5722829 65585-577 HUMAN OTC DRUG WhiskCare 377 Benzalkonium Chloride SOAP TOPICAL 20051012 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 1 mg/mL 65588-2210_7b3a0d7b-acdb-4a98-a1e1-4319bfc754e6 65588-2210 HUMAN OTC DRUG Maximum-H HYDROCORTISONE CREAM TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part348 New GPC, Inc. HYDROCORTISONE 1 g/100g 65588-2230_b04435ae-1f67-4bc6-ad07-eceb51ea3d37 65588-2230 HUMAN OTC DRUG Medisilke Night HYDROQUINONE CREAM TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part358A New GPC, Inc. HYDROQUINONE 2 g/100g 65597-101_1bb7a930-17dd-11e4-8c21-0800200c9a66 65597-101 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 Daiichi Sankyo, Inc. OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65597-103_1bb7a930-17dd-11e4-8c21-0800200c9a66 65597-103 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 Daiichi Sankyo, Inc. OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65597-104_1bb7a930-17dd-11e4-8c21-0800200c9a66 65597-104 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 Daiichi Sankyo, Inc. OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65597-105_569082c2-17dd-11e4-8c21-0800200c9a66 65597-105 HUMAN PRESCRIPTION DRUG Benicar HCT olmesartan medoxomil-hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 Daiichi Sankyo, Inc. HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5; 20 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65597-106_569082c2-17dd-11e4-8c21-0800200c9a66 65597-106 HUMAN PRESCRIPTION DRUG Benicar HCT olmesartan medoxomil-hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 Daiichi Sankyo, Inc. HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65597-107_569082c2-17dd-11e4-8c21-0800200c9a66 65597-107 HUMAN PRESCRIPTION DRUG Benicar HCT olmesartan medoxomil-hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 Daiichi Sankyo, Inc. HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65597-110_8c973fd2-17a6-11e4-8c21-0800200c9a66 65597-110 HUMAN PRESCRIPTION DRUG Azor amlodipine besylate and olmesartan medoxomil TABLET, FILM COATED ORAL 20070926 NDA NDA022100 Daiichi Sankyo, Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65597-111_8c973fd2-17a6-11e4-8c21-0800200c9a66 65597-111 HUMAN PRESCRIPTION DRUG Azor amlodipine besylate and olmesartan medoxomil TABLET, FILM COATED ORAL 20070926 NDA NDA022100 Daiichi Sankyo, Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65597-112_8c973fd2-17a6-11e4-8c21-0800200c9a66 65597-112 HUMAN PRESCRIPTION DRUG Azor amlodipine besylate and olmesartan medoxomil TABLET, FILM COATED ORAL 20070926 NDA NDA022100 Daiichi Sankyo, Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65597-113_8c973fd2-17a6-11e4-8c21-0800200c9a66 65597-113 HUMAN PRESCRIPTION DRUG Azor amlodipine besylate and olmesartan medoxomil TABLET, FILM COATED ORAL 20070926 NDA NDA022100 Daiichi Sankyo, Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65597-114_3fc1ae70-17d8-11e4-8c21-0800200c9a66 65597-114 HUMAN PRESCRIPTION DRUG Tribenzor olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide TABLET, FILM COATED ORAL 20100731 NDA NDA200175 Daiichi Sankyo, Inc. AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 5; 12.5; 20 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65597-115_3fc1ae70-17d8-11e4-8c21-0800200c9a66 65597-115 HUMAN PRESCRIPTION DRUG Tribenzor olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide TABLET, FILM COATED ORAL 20100731 NDA NDA200175 Daiichi Sankyo, Inc. AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 5; 12.5; 40 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65597-116_3fc1ae70-17d8-11e4-8c21-0800200c9a66 65597-116 HUMAN PRESCRIPTION DRUG Tribenzor olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide TABLET, FILM COATED ORAL 20100731 NDA NDA200175 Daiichi Sankyo, Inc. AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 5; 25; 40 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65597-117_3fc1ae70-17d8-11e4-8c21-0800200c9a66 65597-117 HUMAN PRESCRIPTION DRUG Tribenzor olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide TABLET, FILM COATED ORAL 20100731 NDA NDA200175 Daiichi Sankyo, Inc. AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 10; 12.5; 40 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65597-118_3fc1ae70-17d8-11e4-8c21-0800200c9a66 65597-118 HUMAN PRESCRIPTION DRUG Tribenzor olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide TABLET, FILM COATED ORAL 20100731 NDA NDA200175 Daiichi Sankyo, Inc. AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 10; 25; 40 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65597-701_20ab0340-890f-11e3-baa8-0800200c9a66 65597-701 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride TABLET, FILM COATED ORAL 20000901 NDA NDA021176 Daiichi Sankyo, inc. COLESEVELAM HYDROCHLORIDE 625 mg/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 65597-902_20ab0340-890f-11e3-baa8-0800200c9a66 65597-902 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride FOR SUSPENSION ORAL 20100101 NDA NDA022362 Daiichi Sankyo, inc. COLESEVELAM HYDROCHLORIDE 3.75 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 65597-903_20ab0340-890f-11e3-baa8-0800200c9a66 65597-903 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride FOR SUSPENSION ORAL 20100101 NDA NDA022362 Daiichi Sankyo, inc. COLESEVELAM HYDROCHLORIDE 1.875 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 65601-141_9d7db35f-bc93-4198-80a1-b81948d9fc6f 65601-141 HUMAN OTC DRUG Winning Hands Antibacterial Chloroxylenol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. CHLOROXYLENOL 3.75 mg/mL 65601-170_6615baf1-1a0e-4d3c-b6a2-3bc261cad0d3 65601-170 HUMAN OTC DRUG Direct Effect E-2 Benzalkonium Chloride SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. BENZALKONIUM CHLORIDE 25 mg/mL 65601-717_0ff8d53e-36b5-4a7d-922f-2cdf41d848f3 65601-717 HUMAN OTC DRUG Clario E2 Antibacterial Foaming Skin Cleanser Benzalkonium Chloride SOAP TOPICAL 20140117 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. BENZALKONIUM CHLORIDE 1.3 mg/mL 65601-736_f89eece0-4cb8-4e75-ad8a-cbbee0bb29df 65601-736 HUMAN OTC DRUG Winning Hands Premium Antibacterial Chloroxylenol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. CHLOROXYLENOL 5 mg/mL 65601-740_d3bd31e3-75e6-4dd0-817b-5cff1d974c4e 65601-740 HUMAN OTC DRUG Clario Antibacterial Chloroxylenol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. CHLOROXYLENOL 3.75 mg/mL 65601-741_4d8e6fa8-f31f-41fa-80fe-a0711a4e9a55 65601-741 HUMAN OTC DRUG Triton AB-741 Chloroxylenol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. CHLOROXYLENOL 3.75 mg/mL 65601-744_51ea0341-50b0-4c10-82cd-a2143a523030 65601-744 HUMAN OTC DRUG Winning Hands Antibacterial Tricolsan SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. TRICLOSAN 3 mg/mL 65601-751_d7c89862-7daf-4ca7-97a4-b2e2ad0079f5 65601-751 HUMAN OTC DRUG Winning Hands Foaming Antibacterial Tricolsan SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. TRICLOSAN 3 mg/mL 65601-752_2e3e6107-9f7c-4f8f-ae91-7baf40b9a53b 65601-752 HUMAN OTC DRUG Winning Hands Alcohol Free Benzalkonium Chloride SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. BENZALKONIUM CHLORIDE 1.3 mg/mL 65601-755_05fc7690-7e18-49e4-9986-ad7870a416c9 65601-755 HUMAN OTC DRUG Winning Hands Alcohol Foaming Alcohol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. ALCOHOL .7 mL/mL 65601-757_95d7bcdc-1e11-4961-9388-390af47d4f63 65601-757 HUMAN OTC DRUG Clario Foaming Antibacterial Skin Cleanser Tricolsan SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. TRICLOSAN 3 mg/mL 65601-759_de3bb88d-a1df-4b6e-9750-63dfaf764694 65601-759 HUMAN OTC DRUG Clario Ultra Blue Antibacterial Foaming Skin Cleanser Tricolsan SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. TRICLOSAN 6 mg/mL 65601-765_6fe201e1-3d99-4c89-9a44-1cbb16ec8092 65601-765 HUMAN OTC DRUG Knuckle Under Medicated Chloroxylenol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. CHLOROXYLENOL 5 mg/mL 65601-772_2c004352-27a7-4ed4-8c40-01b52a00882d 65601-772 HUMAN OTC DRUG Winning Hands Hand Sanitizer Alcohol GEL TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. ALCOHOL .62 mL/mL 65601-774_f2108a51-ec9b-460f-b2b9-330fea934af9 65601-774 HUMAN OTC DRUG Clario Foaming Alcohol Instant Hand Sanitizer Alcohol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. ALCOHOL .7 mL/mL 65601-776_66d92578-6843-452a-bca7-467819633f0b 65601-776 HUMAN OTC DRUG Clario Instant Hand Sanitizer Alcohol SOAP TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. ALCOHOL .62 mL/mL 65601-777_ff82b5b8-afe1-4742-afae-e15c4c2ce942 65601-777 HUMAN OTC DRUG Triton HS-777 Alcohol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. ALCOHOL .7 mL/mL 65601-778_c196c001-1e20-4895-8d12-adde20ca448d 65601-778 HUMAN OTC DRUG Clario Free Foaming Hand Sanitizer Benzalkonium Chloride SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. BENZALKONIUM CHLORIDE 1.3 mg/mL 65601-782_41a73868-49cb-477f-be81-8f8e149089af 65601-782 HUMAN OTC DRUG Triton E2-782 Benzalkonium Chloride SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. BENZALKONIUM CHLORIDE 25 mg/mL 65603-001_8af37b23-a407-4af8-888a-edfffe195015 65603-001 HUMAN OTC DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20011020 UNAPPROVED MEDICAL GAS Arkansas Welding & Industrial Supply OXYGEN 992 mL/L 65616-001_bf638664-6afb-4d55-96e1-16682c346082 65616-001 HUMAN OTC DRUG Sterillium Rub Surgical Hand Antiseptic LIQUID TOPICAL 20030501 OTC MONOGRAPH NOT FINAL part333 Bode Chemie Hamburg ALCOHOL 80 mL/100mL 65616-003_89b6f33b-2781-45e1-8067-250d010c1670 65616-003 HUMAN OTC DRUG Sterillium Comfort Alcohol GEL TOPICAL 20070401 OTC MONOGRAPH NOT FINAL part333A BODE Chemie GmbH ALCOHOL 85 mL/100mL 65616-004_792d639d-db60-4849-9144-39ed17b193b0 65616-004 HUMAN OTC DRUG Sterillium Rub Fragrance Free Alcohol LIQUID TOPICAL 20120328 OTC MONOGRAPH NOT FINAL part333A BODE Chemie GmbH ALCOHOL 85 mL/100mL 65616-005_5653be86-99a9-42bb-b76e-9f8ef901b58d 65616-005 HUMAN OTC DRUG Sterillium Med Alcohol LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part333A BODE Chemie GmbH ALCOHOL 85 mL/100mL 65626-017_ca337406-4ea3-4db2-addb-4d1c326d524b 65626-017 HUMAN OTC DRUG Hand Essentials Antibacterial triclosan SOAP TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333E HU-FRIEDY MFG. CO., INC. TRICLOSAN .5 mg/100mL 65626-161_d102e331-fd3f-46ca-9382-2f103afbc853 65626-161 HUMAN OTC DRUG Hand Essentials Skin Repair dimethicone CREAM TOPICAL 20101001 OTC MONOGRAPH FINAL part347 HU-FRIEDY MFG. CO., INC. DIMETHICONE 1.5 mL/100mL 65626-206_a580ebfb-2da9-4a20-9a3c-6244dbb7aef1 65626-206 HUMAN OTC DRUG Hand Essentials Instant Hand Antiseptic ethyl alcohol GEL TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333E Hu-Friedy Mfg. Co., Inc. ALCOHOL 70 mL/100mL 65628-051_f02ad9bb-56d8-156a-e257-01aaeb7c0cf3 65628-051 HUMAN PRESCRIPTION DRUG FIRST BXN Mouthwash Diphenhydramine, Lidocaine, Nystatin KIT ORAL 20090908 UNAPPROVED OTHER CutisPharma, Inc 65628-052_a1e7270c-f306-499e-b0b3-4491f8376123 65628-052 HUMAN PRESCRIPTION DRUG FIRST Dukes Mouthwash Compounding Diphenhydramine Hydrochloride and Hydrocortisone and Nystatin KIT ORAL 20101215 UNAPPROVED DRUG OTHER CutisPharma, Inc. 65628-053_e3f7917c-c56a-44e5-9f10-2128c49744bd 65628-053 HUMAN PRESCRIPTION DRUG FIRST Marys Mouthwash Compounding Diphenhydramine Hydrochloride and Hydrocortisone and Nystatin and Tetracycline Hydrochloride KIT ORAL 20101215 UNAPPROVED DRUG OTHER CutisPharma, Inc. 65643-010_af1e5df5-7d6d-4052-b2c5-61f9507ec50e 65643-010 HUMAN OTC DRUG FlexGen Menthol CREAM TOPICAL 20061001 OTC MONOGRAPH NOT FINAL part348 Lifetech Resources, LLC MENTHOL 12.5 mg/g 65643-165_055c09fd-3a13-46c5-8add-2a03abf3cd2e 65643-165 HUMAN OTC DRUG Desert Bambu Facial Sunscreen SPF 30 Octinoxate, Octocrylene, Octisalate, and Zinc Oxide CREAM TOPICAL 20080301 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 74.025; 49.35; 59.22; 2.902 mg/mL; mg/mL; mg/mL; mg/mL 65643-166_55b6204f-1f50-4a66-ae83-6d6ad052c70f 65643-166 HUMAN OTC DRUG Desert Bambu Tanning SPF 15 Octinoxate and Avobenzone LOTION TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL 65643-173_542926b1-af1c-409e-9548-bda3ae2c3e25 65643-173 HUMAN OTC DRUG Desert Bambu Lip Balm SPF 15 Octinoxate, Oxybenzone, and Octisalate OINTMENT TOPICAL 20080501 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OCTISALATE; OXYBENZONE 66.825; 35.64; 26.73 mg/mL; mg/mL; mg/mL 65643-325_113e3223-7d36-475b-84cd-ddba585e2936 65643-325 HUMAN OTC DRUG Bellagio Sunscreen For Face SPF 30 Octinoxate, Octocrylene, Octisalate, and Zinc Oxide LOTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 74.25; 49.5; 59.4; 29.106 mg/mL; mg/mL; mg/mL; mg/mL 65643-326_8dcb682e-c6d8-451e-9713-8f1dade7df95 65643-326 HUMAN OTC DRUG Bellagio Sunscreen SPF 15 Octinoxate and Avobenzone LOTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC AVOBENZONE; OCTINOXATE 20.48; 76.8 mg/mL; mg/mL 65643-327_55008b6a-5c98-42b9-8acf-cbddd81e76d6 65643-327 HUMAN OTC DRUG Bellagio Sunscreen SPF 8 Octinoxate and Oxybenzone LOTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OXYBENZONE 49.7; 29.82 mg/mL; mg/mL 65643-329_d9299e47-aa16-419c-b4cf-deb1f886170c 65643-329 HUMAN OTC DRUG Bellagio Sunscreen SPF 30 Octinoxate, Octocrylene, Oxybenzone, and Octisalate SPRAY TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 68.32; 48.8; 68.32; 58.56 mg/mL; mg/mL; mg/mL; mg/mL 65643-330_591dc37e-4d2b-4421-bd66-a441ad567241 65643-330 HUMAN OTC DRUG Bellagio Sunscreen SPF 15 Octinoxate, Avobenzone, and Octisalate SPRAY TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 19.16; 71.85; 47.9 mg/mL; mg/mL; mg/mL 65643-331_c42de5d9-6610-4aa8-8f4b-e7c058432a29 65643-331 HUMAN OTC DRUG Bellagio Dark Tanning SPF 2 Octinoxate and Oxybenzone SPRAY TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OXYBENZONE 9.49; 9.49 mg/mL; mg/mL 65643-333_a157f263-e955-493b-a5ea-1bd78cc82e04 65643-333 HUMAN OTC DRUG Bellagio Lip Moisturizer SPF 15 Octinoxate, Octisalate, and Oxybenzone OINTMENT TOPICAL 20090201 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OCTISALATE; OXYBENZONE 64.26; 36.72; 32.13 mg/g; mg/g; mg/g 65643-334_c2265afb-8543-49d2-9ef8-49204e60d967 65643-334 HUMAN OTC DRUG Bellagio Sunscreen SPF 30 Homosalate, Octinoxate, Octocrylene, and Oxybenzone LOTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 100.7; 70.49; 65.455; 55.385 mg/mL; mg/mL; mg/mL; mg/mL 65643-335_6ff19afa-8f16-4d33-99b6-04d8530c48a1 65643-335 HUMAN OTC DRUG Bellagio Sunscreen SPF 45 Homosalate, Octinoxate, Octisalate, Oxybenzone, and Zinc Oxide LOTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 143.22; 66.495; 51.15; 51.15; 28.03 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 65643-336_7546ca55-e729-47ca-9130-f27f71e32c80 65643-336 HUMAN OTC DRUG Bellagio Childrens Sunscreen SPF 45 Homosalate, Octinoxate, Octisalate, Oxybenzone, and Zinc Oxide LOTION TOPICAL 20090201 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 141.904; 65.884; 50.68; 50.68; 27.773 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 65643-406_6f87d664-53dd-4573-ac1e-14191aecfde5 65643-406 HUMAN OTC DRUG Celadrin Menthol CREAM TOPICAL 20061001 OTC MONOGRAPH NOT FINAL part348 Lifetech Resources, LLC MENTHOL 12.5 mg/g 65643-415_390610ed-5b67-4203-8afa-3ac93856f989 65643-415 HUMAN OTC DRUG Desert Bambu Dark Tanning SPF 2 Octinoxate and Oxybenzone SPRAY TOPICAL 20080601 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OXYBENZONE 9.49; 9.49 mg/mL; mg/mL 65643-416_fca2fd30-7f08-49a4-95a2-bdcb018273a4 65643-416 HUMAN OTC DRUG Desert Bambu Tanning SPF 6 Octinoxate and Avobenzone SPRAY TOPICAL 20080601 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC AVOBENZONE; OCTINOXATE 18.94; 37.88 mg/mL; mg/mL 65643-417_7715c7f4-32b2-4bff-95a5-36aa69a4473d 65643-417 HUMAN OTC DRUG Desert Bambu Tanning SPF 15 Octinoxate, Avobenzone, and Octisalate SPRAY TOPICAL 20080501 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 19.08; 71.55; 47.7 mg/mL; mg/mL; mg/mL 65643-418_d1ed0a37-1189-4869-9e06-e4f4e95e4f78 65643-418 HUMAN OTC DRUG Desert Bambu Sunscreen SPF 15 Octinoxate and Avobenzone LOTION TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL 65643-419_fed50f59-cba9-40ff-91fa-01a0c7f6630c 65643-419 HUMAN OTC DRUG Desert Bambu Sunscreen SPF 30 Octinoxate, Octocrylene, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 73.5; 68.25; 57.75; 47.25 mg/mL; mg/mL; mg/mL; mg/mL 65649-101_dcdf9911-e3fd-4f6e-8b29-ba036af1d101 65649-101 HUMAN PRESCRIPTION DRUG COLAZAL balsalazide disodium CAPSULE ORAL 20000718 NDA NDA020610 Salix Pharmaceuticals, Inc. BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 65649-102_f3376152-74a9-40f0-9301-793c5017ef87 65649-102 HUMAN PRESCRIPTION DRUG GIAZO balsalazide disodium TABLET, FILM COATED ORAL 20120202 NDA NDA022205 Salix Pharmaceuticals, Inc. BALSALAZIDE DISODIUM 1.1 g/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 65649-103_c852cbed-dad5-4abb-b59d-975d32b239e5 65649-103 HUMAN PRESCRIPTION DRUG APRISO mesalamine CAPSULE, EXTENDED RELEASE ORAL 20081031 NDA NDA022301 Salix Pharmaceuticals, Inc. MESALAMINE 375 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 65649-201_5ac8eadf-78d7-4bd9-b319-636e9e9f9de6 65649-201 HUMAN PRESCRIPTION DRUG MoviPrep POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE KIT 20061001 NDA NDA021881 Salix Pharmaceuticals, Inc. 65649-211_494420bd-50df-47f5-a243-116042be6042 65649-211 HUMAN PRESCRIPTION DRUG PEPCID FAMOTIDINE POWDER, FOR SUSPENSION ORAL 19870601 NDA NDA019527 Salix Pharmaceuticals, Inc. FAMOTIDINE 40 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 65649-231_5d8deea4-acde-4f70-b4c9-e6f2b4902700 65649-231 HUMAN PRESCRIPTION DRUG Azasan AZATHIOPRINE TABLET ORAL 20030401 ANDA ANDA075252 Salix Pharmaceuticals, Inc. AZATHIOPRINE 75 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 65649-241_5d8deea4-acde-4f70-b4c9-e6f2b4902700 65649-241 HUMAN PRESCRIPTION DRUG Azasan AZATHIOPRINE TABLET ORAL 20030401 ANDA ANDA075252 Salix Pharmaceuticals, Inc. AZATHIOPRINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 65649-301_8e9dacf5-610a-4bd7-9bab-fda11af3af6e 65649-301 HUMAN PRESCRIPTION DRUG XIFAXAN RIFAXIMIN TABLET ORAL 20040725 NDA NDA021361 Salix Pharmaceuticals, Inc. RIFAXIMIN 200 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 65649-303_8e9dacf5-610a-4bd7-9bab-fda11af3af6e 65649-303 HUMAN PRESCRIPTION DRUG XIFAXAN RIFAXIMIN TABLET ORAL 20100501 NDA NDA021361 Salix Pharmaceuticals, Inc. RIFAXIMIN 550 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 65649-311_78c607b4-71dd-4ec3-9bc5-5de965def70d 65649-311 HUMAN PRESCRIPTION DRUG DIURIL CHLOROTHIAZIDE SUSPENSION ORAL 19620215 NDA NDA011870 Salix Pharmaceuticals, Inc. CHLOROTHIAZIDE 250 mg/5mL Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65649-401_b07bef7b-0266-49f9-bf17-ea15afc85d85 65649-401 HUMAN PRESCRIPTION DRUG Anusol HC hydrocortisone CREAM TOPICAL 19840606 ANDA ANDA088250 Salix Pharmaceuticals, Inc HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 65649-411_900177a6-ffb4-4a0e-aa77-94959a9faaf5 65649-411 HUMAN PRESCRIPTION DRUG Anusol HC HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 20040601 UNAPPROVED DRUG OTHER Salix Pharmaceuticals, Inc HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 65649-431_d4fdf8cc-562f-4395-b6df-25fcba814dd8 65649-431 HUMAN PRESCRIPTION DRUG METOZOLV ODT METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING ORAL 20090904 NDA NDA022246 Salix Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 65649-432_d4fdf8cc-562f-4395-b6df-25fcba814dd8 65649-432 HUMAN PRESCRIPTION DRUG METOZOLV ODT METOCLOPRAMIDE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING ORAL 20090904 NDA NDA022246 Salix Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 65649-501_ee2a3e45-a361-4d12-9036-f72059cb6f7e 65649-501 HUMAN PRESCRIPTION DRUG Proctocort HYDROCORTISONE CREAM TOPICAL 20040601 UNAPPROVED DRUG OTHER Salix Pharmaceuticals, Inc HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 65649-511_3b20d3b8-3103-47a0-8bbb-a4e17d3d4b71 65649-511 HUMAN PRESCRIPTION DRUG Proctocort HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 20040601 UNAPPROVED DRUG OTHER Salix Pharmaceuticals, Inc HYDROCORTISONE ACETATE 30 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 65649-551_efdd5e38-d2d1-4105-9ea0-49a3c0ec2d67 65649-551 HUMAN PRESCRIPTION DRUG Relistor Methylnaltrexone bromide INJECTION, SOLUTION SUBCUTANEOUS 20080801 NDA NDA021964 Salix Pharmaceuticals, Inc. METHYLNALTREXONE BROMIDE 12 mg/.6mL Opioid Antagonist [EPC],Opioid Antagonists [MoA],Quaternary Ammonium Compounds [Chemical/Ingredient] 65649-552_efdd5e38-d2d1-4105-9ea0-49a3c0ec2d67 65649-552 HUMAN PRESCRIPTION DRUG Relistor Methylnaltrexone bromide INJECTION, SOLUTION SUBCUTANEOUS 20120201 NDA NDA021964 Salix Pharmaceuticals, Inc. METHYLNALTREXONE BROMIDE 8 mg/.4mL Opioid Antagonist [EPC],Opioid Antagonists [MoA],Quaternary Ammonium Compounds [Chemical/Ingredient] 65649-553_efdd5e38-d2d1-4105-9ea0-49a3c0ec2d67 65649-553 HUMAN PRESCRIPTION DRUG Relistor Methylnaltrexone bromide KIT 20080801 NDA NDA021964 Salix Pharmaceuticals, Inc. 65649-601_95627a10-6a78-457d-9f88-6e284f8855b3 65649-601 HUMAN PRESCRIPTION DRUG Visicol SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, AND SODIUM PHOSPHATE, DIBASIC ANHYDROUS TABLET ORAL 20001001 NDA NDA021097 Salix Pharmaceuticals, Inc SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .398; 1.102 g/1; g/1 65649-651_5c94c742-1528-44c0-99c1-ee4f1c995b2e 65649-651 HUMAN PRESCRIPTION DRUG Uceris budesonide AEROSOL, FOAM RECTAL 20141201 NDA NDA205613 Salix Pharmaceuticals, Inc. BUDESONIDE 28 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 65649-701_a2094ba0-f62d-4ae1-a8a5-116e39f10238 65649-701 HUMAN PRESCRIPTION DRUG OsmoPrep SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUS TABLET ORAL 20060515 NDA NDA021892 Salix Pharmaceuticals, Inc. SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .398; 1.102 g/1; g/1 65649-802_810b61ac-32b1-4a6d-aa93-5dcc391e06a7 65649-802 HUMAN PRESCRIPTION DRUG FULYZAQ Crofelemer TABLET, COATED ORAL 20121231 NDA NDA202292 Salix Pharmaceuticals, Inc. CROFELEMER 125 mg/1 Antidiarrheal [EPC] 65662-403_d1547eb2-a3c3-43c1-805b-50c1e9c72047 65662-403 HUMAN OTC DRUG Alka-Seltzer XTRA STRENGTH Anhydrous Citric Acid, Sodium Bicarbonate, and Aspirin GRANULE, EFFERVESCENT ORAL 20100302 OTC MONOGRAPH FINAL part341 Bayer Bitterfeld GmbH ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE 1000; 500; 1985 mg/1; mg/1; mg/1 65662-408_f7cb13c7-6613-4fc2-97b0-dc6d7eaee118 65662-408 HUMAN OTC DRUG Alka-Seltzer HEARTBURN Anhydrous Citric Acid and Sodium Bicarbonate GRANULE, EFFERVESCENT ORAL 20100302 OTC MONOGRAPH FINAL part341 Bayer Bitterfeld GmbH ANHYDROUS CITRIC ACID; SODIUM BICARBONATE 1000; 1940 mg/1; mg/1 65663-019_2561b68e-e638-4a1f-9030-e5db72ebca4e 65663-019 HUMAN OTC DRUG Bodycology white gardenia anti-bacterial scrubbing hand soap Triclosan LIQUID TOPICAL 20090721 OTC MONOGRAPH NOT FINAL part333 American Blending and Filling TRICLOSAN .3 mL/100mL 65663-020_e6185362-4152-4722-95c6-0dc6903027de 65663-020 HUMAN OTC DRUG Bodycology white gardenia anti-bacterial foaming hand soap Triclosan LIQUID TOPICAL 20090721 OTC MONOGRAPH NOT FINAL part333 American Blending and Filling TRICLOSAN .3 mL/100mL 65663-023_52f8212f-1cda-4b32-ae59-723820957345 65663-023 HUMAN OTC DRUG Bodycology Peppermint Sugar anti-bacterial scrubbing hand soap Triclosan LIQUID TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part333 American Blending and Filling TRICLOSAN .3 mL/100mL 65663-024_cdd5dde6-c64c-4ef0-b2b9-00b6420e9ea5 65663-024 HUMAN OTC DRUG Bodycology Sparkling Cranberry anti-bacterial scrubbing hand soap Triclosan LIQUID TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part333 American Blending and Filling TRICLOSAN .3 mL/100mL 65676-0001_586fade3-e119-479c-8aa4-8c233ded6c3a 65676-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000329 UNAPPROVED MEDICAL GAS KC's Medical Home Care Supplies, Inc. OXYGEN 99 L/100L 65689-001_af75cc5e-9860-4672-a823-028c913d1e7c 65689-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990101 UNAPPROVED MEDICAL GAS Oxygen One, Inc. OXYGEN 992 mL/L 65691-0005_2bf98b73-8d8c-4f32-b05e-f049f144a10a 65691-0005 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20120307 ANDA ANDA202168 Cadila Pharmaceuticals Limited ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 65691-0006_2bf98b73-8d8c-4f32-b05e-f049f144a10a 65691-0006 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20120308 ANDA ANDA202168 Cadila Pharmaceuticals Limited ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 65691-0088_7f4be365-06b6-4912-9026-5efcb474777d 65691-0088 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20140130 ANDA ANDA202437 Cadila Pharmaceuticals Limited FOLIC ACID 1 mg/1 65691-0089_3492297f-1a50-4898-ac06-03fe134c17e6 65691-0089 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20140311 ANDA ANDA201445 Cadila Pharmaceuticals Limited ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 65691-0104_52572d94-d47b-428f-acc7-67147c5b0681 65691-0104 HUMAN PRESCRIPTION DRUG OFLOXACIN OFLOXACIN TABLET, FILM COATED ORAL 20140924 ANDA ANDA091656 Cadila Pharmaceuticals Limited OFLOXACIN 200 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 65691-0105_52572d94-d47b-428f-acc7-67147c5b0681 65691-0105 HUMAN PRESCRIPTION DRUG OFLOXACIN OFLOXACIN TABLET, FILM COATED ORAL 20140924 ANDA ANDA091656 Cadila Pharmaceuticals Limited OFLOXACIN 300 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 65691-0106_52572d94-d47b-428f-acc7-67147c5b0681 65691-0106 HUMAN PRESCRIPTION DRUG OFLOXACIN OFLOXACIN TABLET, FILM COATED ORAL 20140924 ANDA ANDA091656 Cadila Pharmaceuticals Limited OFLOXACIN 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 65691-0107_4b4f9bc8-a02f-42b7-8d86-45ad070ace71 65691-0107 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET ORAL 20140924 ANDA ANDA203845 Cadila Pharmaceuticals Limited HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 65691-0108_4b4f9bc8-a02f-42b7-8d86-45ad070ace71 65691-0108 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET ORAL 20140924 ANDA ANDA203845 Cadila Pharmaceuticals Limited HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 65691-0109_4b4f9bc8-a02f-42b7-8d86-45ad070ace71 65691-0109 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET ORAL 20140924 ANDA ANDA203845 Cadila Pharmaceuticals Limited HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 65692-0126_14f3ae53-b2ed-4063-9d8a-15f6744ca192 65692-0126 HUMAN OTC DRUG Goats Milk Lait de Chevre OCTINOXATE, OXYBENZONE OINTMENT TOPICAL 20050511 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. OCTINOXATE; OXYBENZONE .35999; .144 g/4.25g; g/4.25g 65692-0262_95e9b987-740a-49df-822f-9362fbec4264 65692-0262 HUMAN OTC DRUG Natural SUN SPF 30 Green Tea ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. TITANIUM DIOXIDE; ZINC OXIDE 8; 24 g/118mL; g/118mL 65692-0263_44d07a49-9998-4497-b560-a5edbac7fbe7 65692-0263 HUMAN OTC DRUG Natural SUN SPF 30 Unscented ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. TITANIUM DIOXIDE; ZINC OXIDE 8; 24 g/118mL; g/118mL 65692-0264_64083af2-c438-4ef3-8ad9-1aa304ce7df9 65692-0264 HUMAN OTC DRUG Natural SUN SPF 30 Active Lifestyles ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. TITANIUM DIOXIDE; ZINC OXIDE 8; 24 g/118mL; g/118mL 65692-0266_24fb3cfb-e6f3-4513-89f5-7cc4534452fe 65692-0266 HUMAN OTC DRUG Natural SUN Saving Face SPF 15 ZINC OXIDE LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. ZINC OXIDE 24 g/68mL 65692-0273_2e39d153-8c11-4280-a274-fe519c5b24a6 65692-0273 HUMAN OTC DRUG Natural SUN SPF 26 Unscented ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. TITANIUM DIOXIDE; ZINC OXIDE 8; 24 g/118mL; g/118mL 65692-0301_8abd6ad9-c4ac-465a-a8b6-de03a93af60c 65692-0301 HUMAN OTC DRUG Spearmint SPF 15 Lip AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20121201 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .09; .28; .21; .06 g/4.25g; g/4.25g; g/4.25g; g/4.25g 65692-0302_8abd6ad9-c4ac-465a-a8b6-de03a93af60c 65692-0302 HUMAN OTC DRUG Beeswax SPF 15 Lip AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20121201 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .09; .28; .21; .06 g/4.25g; g/4.25g; g/4.25g; g/4.25g 65692-0303_8abd6ad9-c4ac-465a-a8b6-de03a93af60c 65692-0303 HUMAN OTC DRUG Pomegranate SPF 15 Lip AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20121201 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .09; .28; .21; .06 g/4.25g; g/4.25g; g/4.25g; g/4.25g 65692-0304_8abd6ad9-c4ac-465a-a8b6-de03a93af60c 65692-0304 HUMAN OTC DRUG Tropical SPF 15 Lip AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20121201 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .09; .28; .21; .06 g/4.25g; g/4.25g; g/4.25g; g/4.25g 65692-0305_8abd6ad9-c4ac-465a-a8b6-de03a93af60c 65692-0305 HUMAN OTC DRUG Vanilla SPF 15 Lip AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20121201 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .09; .28; .21; .06 g/4.25g; g/4.25g; g/4.25g; g/4.25g 65692-1001_045aa4c0-de11-49ac-ade1-c590ed992d38 65692-1001 HUMAN OTC DRUG Raining Rose Antiseptic Hand Sanitizer ETHYL ALCOHOL SPRAY TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part333E Raining Rose, Inc. ALCOHOL 62 mL/100mL 65700-1649_a312752a-fc00-4ec5-939f-4e96eccf46b7 65700-1649 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20000101 UNAPPROVED MEDICAL GAS Major Medical Supply LLC OXYGEN 99 L/100L 65703-5044_610d08c6-b585-46cf-8aaf-49c97256cbc7 65703-5044 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000524 UNAPPROVED MEDICAL GAS Complete Care Medical Inc. OXYGEN 99 L/100L 65722-0123_908a0fae-3e15-4ed6-8a43-b479111741ec 65722-0123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20080801 UNAPPROVED MEDICAL GAS Aretsia Medical Supply OXYGEN 99 L/100L 65734-000_fff42904-fe50-4b45-ab9b-87ba73b35328 65734-000 HUMAN OTC DRUG 3-Step First Aid Kit Povidone-Iodine, Lidocaine Hydrochloride, Benzalkonium Chloride KIT TOPICAL 20030301 OTC MONOGRAPH FINAL part333C Swabplus Inc. 65734-082_b0fe5d94-876d-4240-a4bd-8020e0a87d49 65734-082 HUMAN OTC DRUG 3-in-1 First Aid Povidone-Iodine Swab Povidone-Iodine LIQUID TOPICAL 20030301 OTC MONOGRAPH FINAL part333C Swabplus Inc. POVIDONE-IODINE 10 mg/mL 65734-103_6a5b5f03-f452-4e3f-8ce4-27c019e762fb 65734-103 HUMAN OTC DRUG Insect Bite Relief Benzocaine LIQUID TOPICAL 20030301 OTC MONOGRAPH FINAL part346 Swabplus Inc. BENZOCAINE 15 mg/mL 65734-112_b0fe5d94-876d-4240-a4bd-8020e0a87d49 65734-112 HUMAN OTC DRUG 3 Step First Aid Kit Lidocaine Hydrochloride LIQUID TOPICAL 20030301 OTC MONOGRAPH FINAL part348 Swabplus Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1; 10 mg/mL; mg/mL 65734-270_12c48fc2-d20c-40b5-ba67-0087127c27d8 65734-270 HUMAN OTC DRUG Antiseptic Formula Filled Swab Lidocaine Hydrochloride, Benzalkonium Chloride LIQUID TOPICAL 20030301 OTC MONOGRAPH NOT FINAL part348 Swabplus Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 11; 100 mg/10mL; mg/10mL 65734-300_d24ed1ab-26d1-46d6-ba13-90eebdfeeada 65734-300 HUMAN OTC DRUG Insect Bite Relief Benzocaine LIQUID TOPICAL 20030301 OTC MONOGRAPH FINAL part346 Swabplus Inc. BENZOCAINE 15 mg/mL 65734-317_8d37c3ef-7ea8-493f-80b2-853c1c30bf33 65734-317 HUMAN OTC DRUG Iodine Formula Filled Swab Povidone-Iodine LIQUID TOPICAL 20030301 OTC MONOGRAPH FINAL part333C Swabplus Inc. POVIDONE-IODINE 10 mg/mL 65734-348_e5a35f6d-8de7-4655-9801-9d6f748d7dc2 65734-348 HUMAN OTC DRUG Fungus Relief Swabs Tolnaftate LIQUID TOPICAL 20030301 OTC MONOGRAPH FINAL part333C Swabplus Inc. TOLNAFTATE 1 mg/mL 65734-511_13ab81a2-095e-4d32-9e7a-4ed3abbee96d 65734-511 HUMAN OTC DRUG Isodine Copitos Povidone-Iodine LIQUID TOPICAL 20080601 OTC MONOGRAPH FINAL part333C Swabplus Inc. POVIDONE-IODINE 10 mg/mL 65734-867_76bd4316-2ca7-4e6d-a63c-d8a51b2ae6e0 65734-867 HUMAN OTC DRUG Mouth Sore Relief Applicator Benzocaine LIQUID ORAL 20050601 OTC MONOGRAPH FINAL part333B Swabplus Inc. BENZOCAINE 200 mg/mL 65753-100_aa78a6c9-8968-4bba-9506-fd6720300b85 65753-100 HUMAN OTC DRUG CoreTex Sun X SPF 30 Avobenzone, Homosalate, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130125 OTC MONOGRAPH NOT FINAL part352 CoreTex Products AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 1; 5; 7.5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 65757-300_0f451803-1f98-4fa3-b71f-2bb6f9c5624a 65757-300 HUMAN PRESCRIPTION DRUG VIVITROL naltrexone KIT 20060613 NDA NDA021897 Alkermes, Inc. 65757-301_a74b26b1-e75c-4aea-a7e1-c5091c2771ba 65757-301 HUMAN PRESCRIPTION DRUG VIVITROL naltrexone KIT 20060613 NDA NDA021897 Alkermes, Inc. 65785-034_2593e97a-c175-418a-9234-2b020af7c32b 65785-034 HUMAN OTC DRUG Eyewash Station Additive Concentrate Chlorhexidine gluconate and Propylene Glycol LIQUID OPHTHALMIC 20111115 OTC MONOGRAPH NOT FINAL part349 Niagara Pharmaceuticals Inc. CHLORHEXIDINE GLUCONATE; PROPYLENE GLYCOL 145.6; 280 kg/2800L; kg/2800L 65785-160_c88015eb-5a95-4fe0-ab6e-d958abc7e03a 65785-160 HUMAN OTC DRUG PUR-WASH Water SOLUTION OPHTHALMIC 20110912 NDA NDA022305 Niagara Pharmaceuticals Inc. WATER 929 g/946mL 65785-162_c88015eb-5a95-4fe0-ab6e-d958abc7e03a 65785-162 HUMAN OTC DRUG PUR-WASH Water SOLUTION OPHTHALMIC 20110912 NDA NDA022305 Niagara Pharmaceuticals Inc. WATER 929 g/946mL 65785-164_aeb7ee26-02c6-4e62-a27e-89e2acc2b343 65785-164 HUMAN OTC DRUG PUR-WASH Water SOLUTION OPHTHALMIC 20110912 NDA NDA022305 Niagara Pharmaceuticals Inc. WATER 929 g/946mL 65785-166_edbfeaa1-7a5e-4683-b97d-f302bec9343f 65785-166 HUMAN OTC DRUG PUR-WASH Water SOLUTION OPHTHALMIC 20130524 NDA NDA022305 Niagara Pharmaceuticals Inc. WATER 929 g/946mL 65786-1717_d1491d8b-2bb2-43a5-ab17-a9548a9f5b6e 65786-1717 HUMAN OTC DRUG KleerSight Chlorhexidine Gluconate CONCENTRATE IRRIGATION 20100311 UNAPPROVED DRUG OTHER Bradley Fixtures Corporation CHLORHEXIDINE GLUCONATE 2.36 mL/236mL 65802-001_34be7da2-4ef0-4c3e-9b81-fbbe2f9bbbf6 65802-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Aspirus Keweenaw Home Medical Equipment OXYGEN 99 L/100L 65811-0001_1aa70ce0-bb47-4e50-a5b3-ac8de65a471f 65811-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000720 UNAPPROVED MEDICAL GAS Randle Respiratory Care, Inc. OXYGEN 99 L/100L 65840-100_98963a9d-ade4-4254-ab78-64830dd0d15b 65840-100 HUMAN OTC DRUG Super Bump Relief benzoyl peroxide and salicylic acid CREAM TOPICAL 20110608 OTC MONOGRAPH NOT FINAL part333D Elements Personal Care, Inc. BENZOYL PEROXIDE; SALICYLIC ACID 4; 3 g/100g; g/100g 65841-022_53529c41-d0dd-4b80-b40f-5b3b14b5fa90 65841-022 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20050810 ANDA ANDA076900 Cadila Healthcare Limited ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65841-023_53529c41-d0dd-4b80-b40f-5b3b14b5fa90 65841-023 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20050810 ANDA ANDA076900 Cadila Healthcare Limited ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65841-024_53529c41-d0dd-4b80-b40f-5b3b14b5fa90 65841-024 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20050810 ANDA ANDA076900 Cadila Healthcare Limited ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65841-027_b15f5edd-18be-40d6-90be-e24d0cff0c7c 65841-027 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20050928 ANDA ANDA077060 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65841-028_b15f5edd-18be-40d6-90be-e24d0cff0c7c 65841-028 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65841-028_b5782eec-4370-4fe8-89a1-a86d90c7ac39 65841-028 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100320 ANDA ANDA077064 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65841-029_b15f5edd-18be-40d6-90be-e24d0cff0c7c 65841-029 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65841-029_b5782eec-4370-4fe8-89a1-a86d90c7ac39 65841-029 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100320 ANDA ANDA077064 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65841-030_b15f5edd-18be-40d6-90be-e24d0cff0c7c 65841-030 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65841-030_b5782eec-4370-4fe8-89a1-a86d90c7ac39 65841-030 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100320 ANDA ANDA077064 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65841-039_b15f5edd-18be-40d6-90be-e24d0cff0c7c 65841-039 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20050928 ANDA ANDA077078 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65841-040_cc75866d-3e28-4e21-a37a-ce1e03c0c65a 65841-040 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Cadila Healthcare Limited PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 65841-041_cc75866d-3e28-4e21-a37a-ce1e03c0c65a 65841-041 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Cadila Healthcare Limited PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 65841-042_cc75866d-3e28-4e21-a37a-ce1e03c0c65a 65841-042 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Cadila Healthcare Limited PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 65841-046_8868db13-a0da-438c-a209-e8e600e960c8 65841-046 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077094 Cadila Healthcare Limited RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 65841-050_41773ee7-156f-4987-90a3-bee73419ca41 65841-050 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 Cadila Healthcare Limited MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65841-051_41773ee7-156f-4987-90a3-bee73419ca41 65841-051 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 Cadila Healthcare Limited MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65841-052_85663d65-b47c-4657-ad9f-c5467e102864 65841-052 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65841-053_85663d65-b47c-4657-ad9f-c5467e102864 65841-053 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65841-054_85663d65-b47c-4657-ad9f-c5467e102864 65841-054 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65841-055_85663d65-b47c-4657-ad9f-c5467e102864 65841-055 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65841-056_85663d65-b47c-4657-ad9f-c5467e102864 65841-056 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65841-057_85663d65-b47c-4657-ad9f-c5467e102864 65841-057 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65841-058_85663d65-b47c-4657-ad9f-c5467e102864 65841-058 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65841-059_85663d65-b47c-4657-ad9f-c5467e102864 65841-059 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65841-064_85663d65-b47c-4657-ad9f-c5467e102864 65841-064 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 65841-065_6310c0d3-bcbf-4e27-8322-7ff6be5a1816 65841-065 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Cadila Healthcare Limited SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 65841-066_6310c0d3-bcbf-4e27-8322-7ff6be5a1816 65841-066 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Cadila Healthcare Limited SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 65841-067_6310c0d3-bcbf-4e27-8322-7ff6be5a1816 65841-067 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Cadila Healthcare Limited SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 65841-068_6310c0d3-bcbf-4e27-8322-7ff6be5a1816 65841-068 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Cadila Healthcare Limited SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 65841-069_6310c0d3-bcbf-4e27-8322-7ff6be5a1816 65841-069 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Cadila Healthcare Limited SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 65841-097_163ed927-c227-4822-a9b0-380163458a85 65841-097 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Cadila Healthcare Limited PAROXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-098_163ed927-c227-4822-a9b0-380163458a85 65841-098 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Cadila Healthcare Limited PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-099_163ed927-c227-4822-a9b0-380163458a85 65841-099 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Cadila Healthcare Limited PAROXETINE HYDROCHLORIDE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-129_8868db13-a0da-438c-a209-e8e600e960c8 65841-129 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077094 Cadila Healthcare Limited RIBAVIRIN 600 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 65841-260_12a35e7b-2e56-4b65-9a59-6f19b90b5d7e 65841-260 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin CAPSULE ORAL 20060125 ANDA ANDA077224 Cadila Healthcare Limited RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 65841-536_b02d704e-e241-4acf-97ca-1db0cff62ad0 65841-536 HUMAN PRESCRIPTION DRUG Potassium Citrate Potassium Citrate TABLET, EXTENDED RELEASE ORAL 20140812 ANDA ANDA203546 Cadila Healthcare Limited POTASSIUM CITRATE 5 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 65841-537_b02d704e-e241-4acf-97ca-1db0cff62ad0 65841-537 HUMAN PRESCRIPTION DRUG Potassium Citrate Potassium Citrate TABLET, EXTENDED RELEASE ORAL 20140812 ANDA ANDA203546 Cadila Healthcare Limited POTASSIUM CITRATE 10 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 65841-538_b02d704e-e241-4acf-97ca-1db0cff62ad0 65841-538 HUMAN PRESCRIPTION DRUG Potassium Citrate Potassium Citrate TABLET, EXTENDED RELEASE ORAL 20140812 ANDA ANDA203546 Cadila Healthcare Limited POTASSIUM CITRATE 15 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 65841-601_163ed927-c227-4822-a9b0-380163458a85 65841-601 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Cadila Healthcare Limited PAROXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-602_8e92b44e-846e-4f38-8187-97062a91930d 65841-602 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20070711 ANDA ANDA077621 Cadila Healthcare Limited AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 65841-603_8868db13-a0da-438c-a209-e8e600e960c8 65841-603 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077094 Cadila Healthcare Limited RIBAVIRIN 400 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 65841-613_ed3c2c8f-dfae-403e-baa3-10d3686737e3 65841-613 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20090706 ANDA ANDA079089 Cadila Healthcare Limited BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 65841-614_b440169e-ab85-48cf-9012-1193148b8ec0 65841-614 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070904 ANDA ANDA040597 Cadila Healthcare Limited BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 65841-615_b440169e-ab85-48cf-9012-1193148b8ec0 65841-615 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070904 ANDA ANDA040597 Cadila Healthcare Limited BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 65841-616_d9ea5743-f458-4d2e-b8e0-2853b7f85b5a 65841-616 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Cadila Healthcare Limited CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 65841-617_d9ea5743-f458-4d2e-b8e0-2853b7f85b5a 65841-617 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Cadila Healthcare Limited CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 65841-618_d9ea5743-f458-4d2e-b8e0-2853b7f85b5a 65841-618 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Cadila Healthcare Limited CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 65841-619_d9ea5743-f458-4d2e-b8e0-2853b7f85b5a 65841-619 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Cadila Healthcare Limited CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 65841-620_3a246709-85dd-48ee-af65-4432cea23b23 65841-620 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070921 ANDA ANDA078226 Cadila Healthcare Limited AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 65841-621_3a246709-85dd-48ee-af65-4432cea23b23 65841-621 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070921 ANDA ANDA078226 Cadila Healthcare Limited AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 65841-622_3a246709-85dd-48ee-af65-4432cea23b23 65841-622 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070921 ANDA ANDA078226 Cadila Healthcare Limited AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 65841-626_d8ab8077-f93f-4b45-8cc5-1baf6073f630 65841-626 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080103 ANDA ANDA077580 Cadila Healthcare Limited HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 65841-627_d8ab8077-f93f-4b45-8cc5-1baf6073f630 65841-627 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080103 ANDA ANDA077580 Cadila Healthcare Limited HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] 65841-628_d8ab8077-f93f-4b45-8cc5-1baf6073f630 65841-628 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080103 ANDA ANDA077580 Cadila Healthcare Limited HALOPERIDOL 20 mg/1 Typical Antipsychotic [EPC] 65841-631_d5dd9212-dd1f-40f6-9c46-2542e03cc3ed 65841-631 HUMAN PRESCRIPTION DRUG Amiodarone hydrochloride Amiodarone hydrochloride TABLET ORAL 20090810 ANDA ANDA079029 Cadila Healthcare Limited AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 65841-632_8868db13-a0da-438c-a209-e8e600e960c8 65841-632 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077094 Cadila Healthcare Limited RIBAVIRIN 500 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 65841-633_b356ba48-4115-49ab-93e7-26a45eca9175 65841-633 HUMAN PRESCRIPTION DRUG Hydroxychloroquine sulfate Hydroxychloroquine sulfate TABLET, FILM COATED ORAL 20080103 ANDA ANDA040657 Cadila Healthcare Limited HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 65841-634_64a1d251-fff5-41e8-bf15-b95b99e2b804 65841-634 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20100603 ANDA ANDA077100 Cadila Healthcare Limited DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65841-635_64a1d251-fff5-41e8-bf15-b95b99e2b804 65841-635 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20100603 ANDA ANDA077100 Cadila Healthcare Limited DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65841-636_64a1d251-fff5-41e8-bf15-b95b99e2b804 65841-636 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20100603 ANDA ANDA077100 Cadila Healthcare Limited DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65841-637_c8458e63-55d9-4edc-a093-2e84e88c2e0e 65841-637 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130701 ANDA ANDA078239 Cadila Healthcare Limited DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65841-638_c8458e63-55d9-4edc-a093-2e84e88c2e0e 65841-638 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130701 ANDA ANDA078239 Cadila Healthcare Limited DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65841-639_be46bb22-4cac-4d48-94f8-e9057fc59139 65841-639 HUMAN PRESCRIPTION DRUG divalproex sodium divalproex sodium CAPSULE, COATED PELLETS ORAL 20090127 ANDA ANDA078919 Cadila Healthcare Limited DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65841-640_8305f669-e265-4be0-9131-af93a8767fa6 65841-640 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100629 ANDA ANDA078516 Cadila Healthcare Limited RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 65841-641_8305f669-e265-4be0-9131-af93a8767fa6 65841-641 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100629 ANDA ANDA078516 Cadila Healthcare Limited RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 65841-642_8305f669-e265-4be0-9131-af93a8767fa6 65841-642 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100629 ANDA ANDA078516 Cadila Healthcare Limited RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 65841-647_c5dfd178-6942-4a21-8570-08bd3395a28e 65841-647 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Cadila Healthcare Limited TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65841-648_c5dfd178-6942-4a21-8570-08bd3395a28e 65841-648 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Cadila Healthcare Limited TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65841-649_c5dfd178-6942-4a21-8570-08bd3395a28e 65841-649 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Cadila Healthcare Limited TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65841-650_c5dfd178-6942-4a21-8570-08bd3395a28e 65841-650 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Cadila Healthcare Limited TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65841-651_5768a473-9018-4a96-ab5b-a042495d99c6 65841-651 HUMAN PRESCRIPTION DRUG topiramate topiramate CAPSULE, COATED PELLETS ORAL 20091014 ANDA ANDA078877 Cadila Healthcare Limited TOPIRAMATE 15 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65841-652_5768a473-9018-4a96-ab5b-a042495d99c6 65841-652 HUMAN PRESCRIPTION DRUG topiramate topiramate CAPSULE, COATED PELLETS ORAL 20091014 ANDA ANDA078877 Cadila Healthcare Limited TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65841-654_9af9a5a6-222c-4d59-808a-f9e2fdf5bf89 65841-654 HUMAN PRESCRIPTION DRUG Bromocriptine mesylate Bromocriptine mesylate CAPSULE ORAL 20090123 ANDA ANDA078899 Cadila Healthcare Limited BROMOCRIPTINE MESYLATE 5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 65841-655_c62e7e6a-2df7-4283-b3b5-a9449a426eeb 65841-655 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20101120 ANDA ANDA078832 Cadila Healthcare Limited RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65841-656_c62e7e6a-2df7-4283-b3b5-a9449a426eeb 65841-656 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20101120 ANDA ANDA078832 Cadila Healthcare Limited RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65841-657_c62e7e6a-2df7-4283-b3b5-a9449a426eeb 65841-657 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20101120 ANDA ANDA078832 Cadila Healthcare Limited RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65841-658_c62e7e6a-2df7-4283-b3b5-a9449a426eeb 65841-658 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20101120 ANDA ANDA078832 Cadila Healthcare Limited RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65841-662_fcf151dd-e0b3-4a0c-b148-8e5be1342f2d 65841-662 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080522 ANDA ANDA040874 Cadila Healthcare Limited DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 65841-663_fcf151dd-e0b3-4a0c-b148-8e5be1342f2d 65841-663 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080522 ANDA ANDA040874 Cadila Healthcare Limited DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 65841-664_fcf151dd-e0b3-4a0c-b148-8e5be1342f2d 65841-664 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080522 ANDA ANDA040874 Cadila Healthcare Limited DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 65841-665_44a17ba8-ebc3-46cc-a364-25bcbe8f4495 65841-665 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Cadila Healthcare Limited RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 65841-666_44a17ba8-ebc3-46cc-a364-25bcbe8f4495 65841-666 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Cadila Healthcare Limited RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 65841-667_44a17ba8-ebc3-46cc-a364-25bcbe8f4495 65841-667 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Cadila Healthcare Limited RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 65841-668_44a17ba8-ebc3-46cc-a364-25bcbe8f4495 65841-668 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Cadila Healthcare Limited RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 65841-669_44a17ba8-ebc3-46cc-a364-25bcbe8f4495 65841-669 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Cadila Healthcare Limited RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 65841-670_44a17ba8-ebc3-46cc-a364-25bcbe8f4495 65841-670 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Cadila Healthcare Limited RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 65841-671_be39d9a8-9155-4f59-8a20-11d1b0469129 65841-671 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Cadila Healthcare Limited VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-672_be39d9a8-9155-4f59-8a20-11d1b0469129 65841-672 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Cadila Healthcare Limited VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-673_be39d9a8-9155-4f59-8a20-11d1b0469129 65841-673 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Cadila Healthcare Limited VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-674_be39d9a8-9155-4f59-8a20-11d1b0469129 65841-674 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Cadila Healthcare Limited VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-675_be39d9a8-9155-4f59-8a20-11d1b0469129 65841-675 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Cadila Healthcare Limited VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-680_45b6508d-c6c1-425f-aa62-97c15ed25a31 65841-680 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20090504 ANDA ANDA065433 Cadila Healthcare Limited MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 65841-681_45b6508d-c6c1-425f-aa62-97c15ed25a31 65841-681 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET, FILM COATED ORAL 20090504 ANDA ANDA065477 Cadila Healthcare Limited MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 65841-682_cdd73800-1835-49cf-9e4b-a84f693d8da6 65841-682 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Cadila Healthcare Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65841-683_cdd73800-1835-49cf-9e4b-a84f693d8da6 65841-683 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Cadila Healthcare Limited LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65841-684_cdd73800-1835-49cf-9e4b-a84f693d8da6 65841-684 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Cadila Healthcare Limited LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65841-685_cdd73800-1835-49cf-9e4b-a84f693d8da6 65841-685 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Cadila Healthcare Limited LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65841-686_cdd73800-1835-49cf-9e4b-a84f693d8da6 65841-686 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Cadila Healthcare Limited LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65841-687_cdd73800-1835-49cf-9e4b-a84f693d8da6 65841-687 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Cadila Healthcare Limited LAMOTRIGINE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65841-689_cdd73800-1835-49cf-9e4b-a84f693d8da6 65841-689 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090123 ANDA ANDA078009 Cadila Healthcare Limited LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65841-690_cdd73800-1835-49cf-9e4b-a84f693d8da6 65841-690 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090123 ANDA ANDA078009 Cadila Healthcare Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65841-691_7002e870-b9e6-4bc1-9b6f-6d243904bd9b 65841-691 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121110 ANDA ANDA077652 Cadila Healthcare Limited LEVOFLOXACIN 250 mg/1 65841-692_7002e870-b9e6-4bc1-9b6f-6d243904bd9b 65841-692 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121110 ANDA ANDA077652 Cadila Healthcare Limited LEVOFLOXACIN 500 mg/1 65841-693_7002e870-b9e6-4bc1-9b6f-6d243904bd9b 65841-693 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121110 ANDA ANDA077652 Cadila Healthcare Limited LEVOFLOXACIN 750 mg/1 65841-695_219d14fe-1b45-41bf-a9e4-715853c10160 65841-695 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078225 Cadila Healthcare Limited TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 65841-705_7a628d28-1750-49c9-a3d4-0bf1685b1b5b 65841-705 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20121016 ANDA ANDA078926 Cadila Healthcare Limited GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65841-706_7a628d28-1750-49c9-a3d4-0bf1685b1b5b 65841-706 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20121016 ANDA ANDA078926 Cadila Healthcare Limited GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65841-711_36f5edc8-063f-4506-b856-0c41dd2f7913 65841-711 HUMAN OTC DRUG OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED NASAL 20090924 OTC MONOGRAPH NOT FINAL part341 Cadila Healthcare Limited OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL 65841-712_62b188cc-5fdd-46c8-a2f7-53167bbf7755 65841-712 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Cadila Healthcare Limited ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65841-713_62b188cc-5fdd-46c8-a2f7-53167bbf7755 65841-713 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Cadila Healthcare Limited ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65841-714_62b188cc-5fdd-46c8-a2f7-53167bbf7755 65841-714 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Cadila Healthcare Limited ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65841-715_62b188cc-5fdd-46c8-a2f7-53167bbf7755 65841-715 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Cadila Healthcare Limited ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65841-716_62b188cc-5fdd-46c8-a2f7-53167bbf7755 65841-716 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Cadila Healthcare Limited ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65841-717_62b188cc-5fdd-46c8-a2f7-53167bbf7755 65841-717 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Cadila Healthcare Limited ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65841-718_62b188cc-5fdd-46c8-a2f7-53167bbf7755 65841-718 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Cadila Healthcare Limited ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65841-721_a0a88f04-9a2e-47d1-8276-54da439d4099 65841-721 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20110511 ANDA ANDA090175 Cadila Healthcare Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 65841-722_a0a88f04-9a2e-47d1-8276-54da439d4099 65841-722 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20110511 ANDA ANDA090175 Cadila Healthcare Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 65841-729_b1d1a814-07d0-48fb-8ceb-18547553e34f 65841-729 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Cadila Healthcare Limited LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65841-730_b1d1a814-07d0-48fb-8ceb-18547553e34f 65841-730 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Cadila Healthcare Limited LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65841-731_b1d1a814-07d0-48fb-8ceb-18547553e34f 65841-731 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Cadila Healthcare Limited LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65841-732_7d5f5aaf-cf01-4b79-bf35-fe56de1fad1c 65841-732 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20100410 ANDA ANDA078385 Cadila Healthcare Limited HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65841-733_7d5f5aaf-cf01-4b79-bf35-fe56de1fad1c 65841-733 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20100410 ANDA ANDA078385 Cadila Healthcare Limited HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65841-734_ec54878e-f258-4b45-bd0b-171384d3f61a 65841-734 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20100710 ANDA ANDA078920 Cadila Healthcare Limited PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65841-735_ec54878e-f258-4b45-bd0b-171384d3f61a 65841-735 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20100710 ANDA ANDA078920 Cadila Healthcare Limited PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65841-736_ec54878e-f258-4b45-bd0b-171384d3f61a 65841-736 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20100710 ANDA ANDA078920 Cadila Healthcare Limited PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65841-737_ec54878e-f258-4b45-bd0b-171384d3f61a 65841-737 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20100710 ANDA ANDA078920 Cadila Healthcare Limited PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65841-738_ec54878e-f258-4b45-bd0b-171384d3f61a 65841-738 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20100710 ANDA ANDA078920 Cadila Healthcare Limited PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65841-739_74428b0f-9a14-4190-8fc3-1734a1f9a3cf 65841-739 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Cadila Healthcare Limited PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 65841-740_74428b0f-9a14-4190-8fc3-1734a1f9a3cf 65841-740 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Cadila Healthcare Limited PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 65841-741_74428b0f-9a14-4190-8fc3-1734a1f9a3cf 65841-741 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Cadila Healthcare Limited PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 65841-742_74428b0f-9a14-4190-8fc3-1734a1f9a3cf 65841-742 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Cadila Healthcare Limited PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 65841-743_f521edc7-4dca-4d92-a4ac-6e4082244ccf 65841-743 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, COATED ORAL 20100627 ANDA ANDA078921 Cadila Healthcare Limited ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 65841-744_85b17865-72d8-48a2-bb51-6d0906d075da 65841-744 HUMAN PRESCRIPTION DRUG letrozole letrozole TABLET, FILM COATED ORAL 20110603 ANDA ANDA090405 Cadila Healthcare Limited LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 65841-745_e55102eb-608c-481d-af93-1caf96b37013 65841-745 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140415 ANDA ANDA090321 Cadila Healthcare Limited PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65841-746_e55102eb-608c-481d-af93-1caf96b37013 65841-746 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140415 ANDA ANDA090321 Cadila Healthcare Limited PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65841-747_e55102eb-608c-481d-af93-1caf96b37013 65841-747 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140415 ANDA ANDA090321 Cadila Healthcare Limited PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65841-748_e55102eb-608c-481d-af93-1caf96b37013 65841-748 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140415 ANDA ANDA090321 Cadila Healthcare Limited PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65841-749_a83c4111-71b8-4677-9c8a-15312afcfd9f 65841-749 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20110525 ANDA ANDA090100 Cadila Healthcare Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 65841-750_a83c4111-71b8-4677-9c8a-15312afcfd9f 65841-750 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20110525 ANDA ANDA090100 Cadila Healthcare Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 65841-751_14e16f40-2c7e-457f-8dc6-f966aa8eaafe 65841-751 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 Cadila Healthcare Limited VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-752_14e16f40-2c7e-457f-8dc6-f966aa8eaafe 65841-752 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 Cadila Healthcare Limited VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-753_14e16f40-2c7e-457f-8dc6-f966aa8eaafe 65841-753 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 Cadila Healthcare Limited VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-754_20f498d3-b99e-43e5-b7e0-837627dd31ab 65841-754 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110131 ANDA ANDA090404 Cadila Healthcare Limited TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 65841-755_ffd1924e-985e-417d-a7bc-7be5e5168b31 65841-755 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20111010 ANDA ANDA078898 Cadila Healthcare Limited GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 65841-756_ffd1924e-985e-417d-a7bc-7be5e5168b31 65841-756 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20111010 ANDA ANDA078898 Cadila Healthcare Limited GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 65841-757_ffd1924e-985e-417d-a7bc-7be5e5168b31 65841-757 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20111010 ANDA ANDA078898 Cadila Healthcare Limited GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 65841-758_27a85122-2c3e-4f72-9d35-8982ebd3ebcf 65841-758 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET, FILM COATED ORAL 20121015 ANDA ANDA090460 Cadila Healthcare Limited ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 65841-759_a067fd4b-e7e7-4d18-939b-601f587b2bf1 65841-759 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20121123 ANDA ANDA091352 Cadila Healthcare Limited OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 65841-760_a067fd4b-e7e7-4d18-939b-601f587b2bf1 65841-760 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20121123 ANDA ANDA091352 Cadila Healthcare Limited OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 65841-761_a067fd4b-e7e7-4d18-939b-601f587b2bf1 65841-761 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20121123 ANDA ANDA091352 Cadila Healthcare Limited OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 65841-763_b61ba4f6-87b9-4d3e-a175-2b6a0b9626b4 65841-763 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20130301 ANDA ANDA091534 Cadila Healthcare Limited RANITIDINE HYDROCHLORIDE 25 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 65841-764_b61ba4f6-87b9-4d3e-a175-2b6a0b9626b4 65841-764 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20130301 ANDA ANDA091534 Cadila Healthcare Limited RANITIDINE HYDROCHLORIDE 25 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 65841-767_f8164be0-e9dd-4a83-8d66-9a605dc08dc4 65841-767 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130516 ANDA ANDA202890 Cadila Healthcare Limited ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 65841-768_f8164be0-e9dd-4a83-8d66-9a605dc08dc4 65841-768 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130516 ANDA ANDA202890 Cadila Healthcare Limited ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 65841-769_2ddc2e63-a78b-440c-8a67-b083a52db2cb 65841-769 HUMAN PRESCRIPTION DRUG lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20130823 ANDA ANDA202366 Cadila Healthcare Limited LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 65841-770_2ddc2e63-a78b-440c-8a67-b083a52db2cb 65841-770 HUMAN PRESCRIPTION DRUG lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20130823 ANDA ANDA202366 Cadila Healthcare Limited LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 65841-771_ce85a20d-0826-4a73-b76d-34d9dee75919 65841-771 HUMAN PRESCRIPTION DRUG sirolimus sirolimus TABLET, FILM COATED ORAL 20140115 ANDA ANDA201676 Cadila Healthcare Limited SIROLIMUS .5 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA] 65841-774_f58fa578-b934-4fe6-8951-6524960aa868 65841-774 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140215 ANDA ANDA090728 Cadila Healthcare Limited DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-775_f58fa578-b934-4fe6-8951-6524960aa868 65841-775 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140215 ANDA ANDA090728 Cadila Healthcare Limited DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-776_f58fa578-b934-4fe6-8951-6524960aa868 65841-776 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140215 ANDA ANDA090728 Cadila Healthcare Limited DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-777_f488def2-70ef-4b12-966f-ee73ccf68880 65841-777 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140215 ANDA ANDA091134 Cadila Healthcare Limited ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65841-778_f488def2-70ef-4b12-966f-ee73ccf68880 65841-778 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140215 ANDA ANDA091134 Cadila Healthcare Limited ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65841-779_f488def2-70ef-4b12-966f-ee73ccf68880 65841-779 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140215 ANDA ANDA091134 Cadila Healthcare Limited ETODOLAC 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65841-780_35dc5ed2-b549-4c2b-9e7a-5d92b42fa9b4 65841-780 HUMAN PRESCRIPTION DRUG bupropion bupropion TABLET, EXTENDED RELEASE ORAL 20140215 ANDA ANDA201567 Cadila Healthcare Limited BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 65841-781_e70b386f-c1f8-4e87-bce2-703de69f528c 65841-781 HUMAN PRESCRIPTION DRUG buspirone hydrochloride buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Cadila Healthcare Limited BUSPIRONE HYDROCHLORIDE 5 mg/1 65841-782_e70b386f-c1f8-4e87-bce2-703de69f528c 65841-782 HUMAN PRESCRIPTION DRUG buspirone hydrochloride buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Cadila Healthcare Limited BUSPIRONE HYDROCHLORIDE 10 mg/1 65841-783_e70b386f-c1f8-4e87-bce2-703de69f528c 65841-783 HUMAN PRESCRIPTION DRUG buspirone hydrochloride buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Cadila Healthcare Limited BUSPIRONE HYDROCHLORIDE 15 mg/1 65841-784_e70b386f-c1f8-4e87-bce2-703de69f528c 65841-784 HUMAN PRESCRIPTION DRUG buspirone hydrochloride buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Cadila Healthcare Limited BUSPIRONE HYDROCHLORIDE 30 mg/1 65841-799_fcd24b30-4734-4633-b7ab-30f67e506e5d 65841-799 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140527 ANDA ANDA090739 Cadila Healthcare Limited DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-800_fcd24b30-4734-4633-b7ab-30f67e506e5d 65841-800 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140527 ANDA ANDA090739 Cadila Healthcare Limited DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-801_fcd24b30-4734-4633-b7ab-30f67e506e5d 65841-801 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140527 ANDA ANDA090739 Cadila Healthcare Limited DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65841-802_7dcf7d4f-c5de-4608-aac4-7c72f54744f9 65841-802 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140910 ANDA ANDA204314 Cadila Healthcare Limited ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 65841-803_7dcf7d4f-c5de-4608-aac4-7c72f54744f9 65841-803 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140910 ANDA ANDA204314 Cadila Healthcare Limited ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 65841-804_82be1f39-b833-4a18-8b24-2ed326b11ef6 65841-804 HUMAN PRESCRIPTION DRUG telmisartan telmisartan TABLET ORAL 20140827 ANDA ANDA203325 Cadila Healthcare Limited TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65841-805_82be1f39-b833-4a18-8b24-2ed326b11ef6 65841-805 HUMAN PRESCRIPTION DRUG telmisartan telmisartan TABLET ORAL 20140827 ANDA ANDA203325 Cadila Healthcare Limited TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65841-806_82be1f39-b833-4a18-8b24-2ed326b11ef6 65841-806 HUMAN PRESCRIPTION DRUG telmisartan telmisartan TABLET ORAL 20140827 ANDA ANDA203325 Cadila Healthcare Limited TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65841-809_b15f5edd-18be-40d6-90be-e24d0cff0c7c 65841-809 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20141209 ANDA ANDA203686 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65841-810_b15f5edd-18be-40d6-90be-e24d0cff0c7c 65841-810 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20141209 ANDA ANDA203686 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65841-811_b15f5edd-18be-40d6-90be-e24d0cff0c7c 65841-811 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20141209 ANDA ANDA203686 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65847-205_e6d04dea-cced-479f-bd5f-74f4fd677e00 65847-205 HUMAN PRESCRIPTION DRUG NATRECOR NESIRITIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010801 NDA NDA020920 Scios LLC NESIRITIDE 1.5 mg/5mL Natriuretic Peptide [EPC],Natriuretic Peptides [Chemical/Ingredient] 65856-216_8888bcb8-feca-4045-9a7f-d7d4963699a2 65856-216 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS Breathe Easy Therapeutics, Inc OXYGEN 99 L/100L 65857-200_1befd04f-8134-489b-b6ab-ad5ecb1e0da5 65857-200 HUMAN PRESCRIPTION DRUG Ammonia N-13 Ammonia N-13 INJECTION INTRAVENOUS 20130225 ANDA ANDA203700 Cardinal Health 414, LLC AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 65857-500_16c2bb11-5b5c-49f2-ab3d-256906ebe4ae 65857-500 HUMAN PRESCRIPTION DRUG Kit for the Preparation of Technetium Tc99m Sestamibi Kit for the Preparation of Technetium Tc99m Sestamibi INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PARENTERAL 20100601 ANDA ANDA078809 Cardinal Health 414, LLC TECHNETIUM TC-99M SESTAMIBI 1 mg/5mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 65862-001_3998ef72-47af-45a6-805d-33e5b53c0959 65862-001 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Aurobindo Pharma Limited MIRTAZAPINE 7.5 mg/1 65862-003_3998ef72-47af-45a6-805d-33e5b53c0959 65862-003 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Aurobindo Pharma Limited MIRTAZAPINE 30 mg/1 65862-005_16a23137-4099-484f-8a96-cb3f40faf72f 65862-005 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Aurobindo Pharma Limited CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-006_16a23137-4099-484f-8a96-cb3f40faf72f 65862-006 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Aurobindo Pharma Limited CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-007_16a23137-4099-484f-8a96-cb3f40faf72f 65862-007 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Aurobindo Pharma Limited CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-008_9fd175ae-ef61-47e9-94af-2c9fbfcbf129 65862-008 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Aurobindo Pharma Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65862-009_9fd175ae-ef61-47e9-94af-2c9fbfcbf129 65862-009 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Aurobindo Pharma Limited METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65862-010_9fd175ae-ef61-47e9-94af-2c9fbfcbf129 65862-010 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Aurobindo Pharma Limited METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65862-011_b42e413c-525c-4034-87d3-5da3a8255088 65862-011 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 Aurobindo Pharma Limited SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-012_b42e413c-525c-4034-87d3-5da3a8255088 65862-012 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 Aurobindo Pharma Limited SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-013_b42e413c-525c-4034-87d3-5da3a8255088 65862-013 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 Aurobindo Pharma Limited SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-014_df173f23-41e7-44b5-bd87-e6e403c249ab 65862-014 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Aurobindo Pharma Limited AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 65862-015_df173f23-41e7-44b5-bd87-e6e403c249ab 65862-015 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Aurobindo Pharma Limited AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 65862-016_0cd3c501-ef2a-4b96-817f-6943bd433234 65862-016 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Aurobindo Pharma Limited AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 65862-017_0cd3c501-ef2a-4b96-817f-6943bd433234 65862-017 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Aurobindo Pharma Limited AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 65862-018_dedda4db-1c41-4fe9-b227-7cad3cc8a153 65862-018 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Aurobindo Pharma Limited CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-019_dedda4db-1c41-4fe9-b227-7cad3cc8a153 65862-019 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Aurobindo Pharma Limited CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-021_10921342-1ee6-4276-bc76-19f139e4e29e 65862-021 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20051208 ANDA ANDA077376 Aurobindo Pharma Limited MIRTAZAPINE 15 mg/1 65862-022_10921342-1ee6-4276-bc76-19f139e4e29e 65862-022 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20051208 ANDA ANDA077376 Aurobindo Pharma Limited MIRTAZAPINE 30 mg/1 65862-023_10921342-1ee6-4276-bc76-19f139e4e29e 65862-023 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20060228 ANDA ANDA077376 Aurobindo Pharma Limited MIRTAZAPINE 45 mg/1 65862-024_0f00e17d-fbd2-4a51-8b9a-b320f255060c 65862-024 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20050919 ANDA ANDA077267 Aurobindo Pharma Limited ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 65862-027_2e39c203-406c-4959-8f57-c4252574fc48 65862-027 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET ORAL 20120522 ANDA ANDA077521 Aurobindo Pharma Limited NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 65862-028_978e4f41-adc8-478d-bd0f-bde8bf36dbd5 65862-028 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20071018 ANDA ANDA077537 Aurobindo Pharma Limited GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 65862-029_978e4f41-adc8-478d-bd0f-bde8bf36dbd5 65862-029 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20071018 ANDA ANDA077537 Aurobindo Pharma Limited GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 65862-030_978e4f41-adc8-478d-bd0f-bde8bf36dbd5 65862-030 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20071018 ANDA ANDA077537 Aurobindo Pharma Limited GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 65862-031_3998ef72-47af-45a6-805d-33e5b53c0959 65862-031 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Aurobindo Pharma Limited MIRTAZAPINE 15 mg/1 65862-032_3998ef72-47af-45a6-805d-33e5b53c0959 65862-032 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Aurobindo Pharma Limited MIRTAZAPINE 45 mg/1 65862-033_3cde9401-2a6a-44af-826c-61e61fceaed6 65862-033 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 20160131 ANDA ANDA065308 Aurobindo Pharma Limited CEFUROXIME AXETIL 125 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-034_3cde9401-2a6a-44af-826c-61e61fceaed6 65862-034 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 20160131 ANDA ANDA065308 Aurobindo Pharma Limited CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-035_3cde9401-2a6a-44af-826c-61e61fceaed6 65862-035 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 20160131 ANDA ANDA065308 Aurobindo Pharma Limited CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-037_9ae9f616-bda7-4e88-be8c-58a4ed35c569 65862-037 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Aurobindo Pharma Limited LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-038_9ae9f616-bda7-4e88-be8c-58a4ed35c569 65862-038 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Aurobindo Pharma Limited LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-039_9ae9f616-bda7-4e88-be8c-58a4ed35c569 65862-039 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Aurobindo Pharma Limited LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-040_9ae9f616-bda7-4e88-be8c-58a4ed35c569 65862-040 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Aurobindo Pharma Limited LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-041_9ae9f616-bda7-4e88-be8c-58a4ed35c569 65862-041 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Aurobindo Pharma Limited LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-042_9ae9f616-bda7-4e88-be8c-58a4ed35c569 65862-042 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Aurobindo Pharma Limited LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-043_5dc999d9-1620-4e85-8db0-4ccd2e8a0179 65862-043 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060314 ANDA ANDA077606 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-044_5dc999d9-1620-4e85-8db0-4ccd2e8a0179 65862-044 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060314 ANDA ANDA077606 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-045_5dc999d9-1620-4e85-8db0-4ccd2e8a0179 65862-045 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060314 ANDA ANDA077606 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-046_2bc2dece-297b-48e7-a71a-b516ec412fc8 65862-046 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA077672 Aurobindo Pharma Limited STAVUDINE 30 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 65862-047_2bc2dece-297b-48e7-a71a-b516ec412fc8 65862-047 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA077672 Aurobindo Pharma Limited STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 65862-048_d8ad9089-7f02-4975-8b8b-7f08de8613de 65862-048 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine SYRUP ORAL 20050919 ANDA ANDA077268 Aurobindo Pharma Limited ZIDOVUDINE 10 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 65862-050_d759bae3-dc70-4a17-91fc-4aab8cc9f5d7 65862-050 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aurobindo Pharma Limited SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 65862-051_d759bae3-dc70-4a17-91fc-4aab8cc9f5d7 65862-051 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aurobindo Pharma Limited SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 65862-052_d759bae3-dc70-4a17-91fc-4aab8cc9f5d7 65862-052 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aurobindo Pharma Limited SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 65862-053_d759bae3-dc70-4a17-91fc-4aab8cc9f5d7 65862-053 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aurobindo Pharma Limited SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 65862-054_d759bae3-dc70-4a17-91fc-4aab8cc9f5d7 65862-054 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aurobindo Pharma Limited SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 65862-057_527ac278-3591-4499-a050-0cb21be635d1 65862-057 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine SUSPENSION ORAL 20120522 ANDA ANDA077702 Aurobindo Pharma Limited NEVIRAPINE HEMIHYDRATE 50 mg/5mL Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] 65862-058_802c3b16-a2be-4adb-81fd-4a83c433864b 65862-058 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Aurobindo Pharma Limited FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 65862-059_802c3b16-a2be-4adb-81fd-4a83c433864b 65862-059 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Aurobindo Pharma Limited FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 65862-060_802c3b16-a2be-4adb-81fd-4a83c433864b 65862-060 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Aurobindo Pharma Limited FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 65862-061_802c3b16-a2be-4adb-81fd-4a83c433864b 65862-061 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Aurobindo Pharma Limited FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 65862-062_ed54e752-ed01-44f8-8ded-26e8ed2b81be 65862-062 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Aurobindo Pharma Limited METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65862-063_ed54e752-ed01-44f8-8ded-26e8ed2b81be 65862-063 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Aurobindo Pharma Limited METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65862-064_ed54e752-ed01-44f8-8ded-26e8ed2b81be 65862-064 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Aurobindo Pharma Limited METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65862-068_c898671e-f22a-4ee2-8bf5-9f7de34f273c 65862-068 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20070524 ANDA ANDA065340 Aurobindo Pharma Limited CEFPROZIL 250 mg/1 65862-069_c898671e-f22a-4ee2-8bf5-9f7de34f273c 65862-069 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20070524 ANDA ANDA065340 Aurobindo Pharma Limited CEFPROZIL 500 mg/1 65862-070_e6e6e42f-fa47-49a3-9fb4-53e893141107 65862-070 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Aurobindo Pharma Limited AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 65862-071_e6e6e42f-fa47-49a3-9fb4-53e893141107 65862-071 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Aurobindo Pharma Limited AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 65862-072_f9c53576-42be-42a7-a9c3-ad7a75ac2dd9 65862-072 HUMAN PRESCRIPTION DRUG Stavudine Stavudine POWDER, FOR SOLUTION ORAL 20081229 20160229 ANDA ANDA077774 Aurobindo Pharma Limited STAVUDINE 1 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 65862-073_44418f84-519a-4c0c-b2a8-7cce684f8b3e 65862-073 HUMAN PRESCRIPTION DRUG Abacavir Abacavir Sulfate TABLET, FILM COATED ORAL 20121217 ANDA ANDA077844 Aurobindo Pharma Limited ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 65862-074_168212d5-16e7-4dd6-85ac-a5a7b27dda6e 65862-074 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide SOLUTION ORAL 20060828 ANDA ANDA077812 Aurobindo Pharma Limited CITALOPRAM HYDROBROMIDE 10 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-076_81c6930b-305b-4331-b681-e675475935fa 65862-076 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 Aurobindo Pharma Limited CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 65862-077_81c6930b-305b-4331-b681-e675475935fa 65862-077 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 Aurobindo Pharma Limited CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 65862-078_81c6930b-305b-4331-b681-e675475935fa 65862-078 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 Aurobindo Pharma Limited CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 65862-079_c9bac2a8-eb1e-436a-a0db-d5ba1b132034 65862-079 HUMAN PRESCRIPTION DRUG Terbinafine Terbinafine Hydrochloride TABLET ORAL 20070702 ANDA ANDA078297 Aurobindo Pharma Limited TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 65862-080_50e39a05-9386-40c1-9d5a-260f12106b67 65862-080 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Aurobindo Pharma Limited GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 65862-081_50e39a05-9386-40c1-9d5a-260f12106b67 65862-081 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Aurobindo Pharma Limited GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 65862-082_50e39a05-9386-40c1-9d5a-260f12106b67 65862-082 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Aurobindo Pharma Limited GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 65862-083_d20b775d-86ca-4452-aebe-bee296b2ad88 65862-083 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20130425 ANDA ANDA065349 Aurobindo Pharma Limited CEFADROXIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-084_d20b775d-86ca-4452-aebe-bee296b2ad88 65862-084 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20130425 ANDA ANDA065349 Aurobindo Pharma Limited CEFADROXIL 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-085_54181b68-0f1d-4ee5-b5c9-7dc7ba2792d3 65862-085 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20070125 ANDA ANDA065352 Aurobindo Pharma Limited CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-086_371a4508-05a0-442c-8328-59f9bec7ce10 65862-086 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol Fumarate TABLET, FILM COATED ORAL 20061227 ANDA ANDA077910 Aurobindo Pharma Limited BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65862-087_371a4508-05a0-442c-8328-59f9bec7ce10 65862-087 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol Fumarate TABLET, FILM COATED ORAL 20061227 ANDA ANDA077910 Aurobindo Pharma Limited BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65862-095_ed85f71c-b88f-4f40-a761-2ffb42847760 65862-095 HUMAN PRESCRIPTION DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED ORAL 20070611 ANDA ANDA065370 Aurobindo Pharma Limited CEFPODOXIME PROXETIL 100 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-096_ed85f71c-b88f-4f40-a761-2ffb42847760 65862-096 HUMAN PRESCRIPTION DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED ORAL 20070611 ANDA ANDA065370 Aurobindo Pharma Limited CEFPODOXIME PROXETIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-097_dbbdb14d-7f87-4c1f-8ce8-2fe6a8b3e43f 65862-097 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20061002 ANDA ANDA078008 Aurobindo Pharma Limited MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65862-098_dbbdb14d-7f87-4c1f-8ce8-2fe6a8b3e43f 65862-098 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20061002 ANDA ANDA078008 Aurobindo Pharma Limited MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65862-099_67ff380f-20d8-40b4-9be6-49a271317d91 65862-099 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20070130 ANDA ANDA065381 Aurobindo Pharma Limited CEFPROZIL 125 mg/5mL 65862-100_67ff380f-20d8-40b4-9be6-49a271317d91 65862-100 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20070130 ANDA ANDA065381 Aurobindo Pharma Limited CEFPROZIL 250 mg/5mL 65862-101_d301fd70-66b5-4370-95a5-6fbdd939862e 65862-101 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070717 ANDA ANDA078021 Aurobindo Pharma Limited AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 65862-102_d301fd70-66b5-4370-95a5-6fbdd939862e 65862-102 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070717 ANDA ANDA078021 Aurobindo Pharma Limited AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 65862-103_d301fd70-66b5-4370-95a5-6fbdd939862e 65862-103 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070717 ANDA ANDA078021 Aurobindo Pharma Limited AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 65862-107_4ce0cda4-c034-452c-bd8b-176c0a7032a4 65862-107 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine CAPSULE ORAL 20060327 ANDA ANDA078128 Aurobindo Pharma Limited ZIDOVUDINE 100 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 65862-111_2bc2dece-297b-48e7-a71a-b516ec412fc8 65862-111 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA077672 Aurobindo Pharma Limited STAVUDINE 15 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 65862-112_2bc2dece-297b-48e7-a71a-b516ec412fc8 65862-112 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA077672 Aurobindo Pharma Limited STAVUDINE 20 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 65862-113_462822dd-695b-483c-8d4c-1ddf3b8763cd 65862-113 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20070919 ANDA ANDA078164 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-116_67d1b6c3-cefa-4dd1-bc4f-63045dd58909 65862-116 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20080522 ANDA ANDA078212 Aurobindo Pharma Limited BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 65862-117_67d1b6c3-cefa-4dd1-bc4f-63045dd58909 65862-117 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20080522 ANDA ANDA078212 Aurobindo Pharma Limited BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 65862-118_67d1b6c3-cefa-4dd1-bc4f-63045dd58909 65862-118 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20080522 ANDA ANDA078212 Aurobindo Pharma Limited BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 65862-119_cff62df3-22b7-4294-804b-5eb33216588b 65862-119 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Aurobindo Pharma Limited RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 65862-120_cff62df3-22b7-4294-804b-5eb33216588b 65862-120 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Aurobindo Pharma Limited RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 65862-121_cff62df3-22b7-4294-804b-5eb33216588b 65862-121 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Aurobindo Pharma Limited RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 65862-122_cff62df3-22b7-4294-804b-5eb33216588b 65862-122 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Aurobindo Pharma Limited RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 65862-123_cff62df3-22b7-4294-804b-5eb33216588b 65862-123 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Aurobindo Pharma Limited RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 65862-124_cff62df3-22b7-4294-804b-5eb33216588b 65862-124 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Aurobindo Pharma Limited RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 65862-125_2f850d65-0d35-4b37-a75b-941738ca839c 65862-125 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 ANDA ANDA078249 Aurobindo Pharma Limited TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 65862-126_2f850d65-0d35-4b37-a75b-941738ca839c 65862-126 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 ANDA ANDA078249 Aurobindo Pharma Limited TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 65862-127_2f850d65-0d35-4b37-a75b-941738ca839c 65862-127 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 ANDA ANDA078249 Aurobindo Pharma Limited TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 65862-128_2f850d65-0d35-4b37-a75b-941738ca839c 65862-128 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 ANDA ANDA078249 Aurobindo Pharma Limited TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 65862-133_2f459b7a-cd5b-4b5f-9be6-82f2f43badc8 65862-133 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070720 ANDA ANDA040780 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-134_2f459b7a-cd5b-4b5f-9be6-82f2f43badc8 65862-134 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070720 ANDA ANDA040780 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-140_4194738a-f0e0-4f19-926d-90f8e56539d8 65862-140 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil GRANULE, FOR SUSPENSION ORAL 20070608 ANDA ANDA065409 Aurobindo Pharma Limited CEFPODOXIME PROXETIL 50 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-141_4194738a-f0e0-4f19-926d-90f8e56539d8 65862-141 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil GRANULE, FOR SUSPENSION ORAL 20070608 ANDA ANDA065409 Aurobindo Pharma Limited CEFPODOXIME PROXETIL 100 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-142_ce81bafc-7ff5-44e9-8d09-fec771463b0e 65862-142 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aurobindo Pharma Limited CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 65862-143_ce81bafc-7ff5-44e9-8d09-fec771463b0e 65862-143 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aurobindo Pharma Limited CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 65862-144_ce81bafc-7ff5-44e9-8d09-fec771463b0e 65862-144 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aurobindo Pharma Limited CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 65862-145_ce81bafc-7ff5-44e9-8d09-fec771463b0e 65862-145 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aurobindo Pharma Limited CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 65862-146_32969d2a-756f-4901-82b5-379e4c2e6eb8 65862-146 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 Aurobindo Pharma Limited SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 65862-146_57510ffd-33cc-4532-bc2a-877a784b015c 65862-146 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 Aurobindo Pharma Limited SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 65862-147_32969d2a-756f-4901-82b5-379e4c2e6eb8 65862-147 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 Aurobindo Pharma Limited SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 65862-147_57510ffd-33cc-4532-bc2a-877a784b015c 65862-147 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 Aurobindo Pharma Limited SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 65862-148_32969d2a-756f-4901-82b5-379e4c2e6eb8 65862-148 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 Aurobindo Pharma Limited SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 65862-148_57510ffd-33cc-4532-bc2a-877a784b015c 65862-148 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 Aurobindo Pharma Limited SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 65862-149_5998d047-1a16-44e2-89af-ed826347f4a2 65862-149 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20071030 ANDA ANDA078341 Aurobindo Pharma Limited FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 65862-154_a187c8ee-8ed9-4f00-aaec-ee30f0977d2e 65862-154 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 Aurobindo Pharma Limited PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-155_a187c8ee-8ed9-4f00-aaec-ee30f0977d2e 65862-155 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 Aurobindo Pharma Limited PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-156_a187c8ee-8ed9-4f00-aaec-ee30f0977d2e 65862-156 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 Aurobindo Pharma Limited PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-157_a187c8ee-8ed9-4f00-aaec-ee30f0977d2e 65862-157 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 Aurobindo Pharma Limited PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-158_454f5fe5-6a57-4099-b158-7edede8bfd10 65862-158 HUMAN PRESCRIPTION DRUG carisoprodol carisoprodol TABLET ORAL 20090806 ANDA ANDA040792 Aurobindo Pharma Limited CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 65862-159_2fc1b143-96a1-4533-86f2-cbe623a3c078 65862-159 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070504 ANDA ANDA078413 Aurobindo Pharma Limited ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 65862-160_2fc1b143-96a1-4533-86f2-cbe623a3c078 65862-160 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070504 ANDA ANDA078413 Aurobindo Pharma Limited ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 65862-161_9f26ea5e-8b75-46f4-bb80-1f695a4d3ba7 65862-161 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride/Hydrochlorothiazide Quinapril Hydrochloride/Hydrochlorothiazide TABLET, FILM COATED ORAL 20070824 ANDA ANDA078450 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-162_9f26ea5e-8b75-46f4-bb80-1f695a4d3ba7 65862-162 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride/Hydrochlorothiazide Quinapril Hydrochloride/Hydrochlorothiazide TABLET, FILM COATED ORAL 20070824 ANDA ANDA078450 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-163_9f26ea5e-8b75-46f4-bb80-1f695a4d3ba7 65862-163 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride/Hydrochlorothiazide Quinapril Hydrochloride/Hydrochlorothiazide TABLET, FILM COATED ORAL 20070824 ANDA ANDA078450 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-164_147eb6a8-f6dc-40d3-bbcf-6af70b0462d1 65862-164 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070612 ANDA ANDA078438 Aurobindo Pharma Limited TRANDOLAPRIL 1 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-165_147eb6a8-f6dc-40d3-bbcf-6af70b0462d1 65862-165 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070612 ANDA ANDA078438 Aurobindo Pharma Limited TRANDOLAPRIL 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-166_147eb6a8-f6dc-40d3-bbcf-6af70b0462d1 65862-166 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070612 ANDA ANDA078438 Aurobindo Pharma Limited TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-167_4c1bb828-bace-4242-b579-441fe6a7be6e 65862-167 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE SOLUTION ORAL 20090915 ANDA ANDA078452 Aurobindo Pharma Limited RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] 65862-168_91cc8489-d129-4ba8-b42c-cb7842d92269 65862-168 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071031 ANDA ANDA078512 Aurobindo Pharma Limited ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65862-169_91cc8489-d129-4ba8-b42c-cb7842d92269 65862-169 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071031 ANDA ANDA078512 Aurobindo Pharma Limited ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65862-170_91cc8489-d129-4ba8-b42c-cb7842d92269 65862-170 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071031 ANDA ANDA078512 Aurobindo Pharma Limited ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 65862-171_133678f3-a0f1-4c2a-8909-3919e4c34afc 65862-171 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078462 Aurobindo Pharma Limited TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65862-172_133678f3-a0f1-4c2a-8909-3919e4c34afc 65862-172 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078462 Aurobindo Pharma Limited TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65862-173_133678f3-a0f1-4c2a-8909-3919e4c34afc 65862-173 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078462 Aurobindo Pharma Limited TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65862-174_133678f3-a0f1-4c2a-8909-3919e4c34afc 65862-174 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078462 Aurobindo Pharma Limited TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65862-175_6fc4e160-e6b1-47ef-a479-e97af4bc9108 65862-175 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 Aurobindo Pharma Limited PENICILLIN V POTASSIUM 250 mg/1 65862-176_6fc4e160-e6b1-47ef-a479-e97af4bc9108 65862-176 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 Aurobindo Pharma Limited PENICILLIN V POTASSIUM 500 mg/1 65862-177_c0220119-0e8d-48a8-b5de-4c92f8225c24 65862-177 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20080107 ANDA ANDA065434 Aurobindo Pharma Limited CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-185_412c6015-45ec-4abb-a43b-6abaf5bc7fc5 65862-185 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090826 ANDA ANDA065442 Aurobindo Pharma Limited CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 65862-185_f61aff38-3e81-4521-99ef-44c136f5d494 65862-185 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090826 ANDA ANDA065442 Aurobindo Pharma Limited CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 65862-186_412c6015-45ec-4abb-a43b-6abaf5bc7fc5 65862-186 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090826 ANDA ANDA065442 Aurobindo Pharma Limited CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 65862-186_f61aff38-3e81-4521-99ef-44c136f5d494 65862-186 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090826 ANDA ANDA065442 Aurobindo Pharma Limited CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 65862-187_76cf758a-607e-4b45-8de2-a0677a5fcc83 65862-187 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Aurobindo Pharma Limited ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 65862-188_76cf758a-607e-4b45-8de2-a0677a5fcc83 65862-188 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Aurobindo Pharma Limited ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 65862-189_76cf758a-607e-4b45-8de2-a0677a5fcc83 65862-189 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Aurobindo Pharma Limited ONDANSETRON HYDROCHLORIDE 24 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 65862-190_62700754-4b64-421a-89dd-736867287197 65862-190 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20080926 ANDA ANDA078643 Aurobindo Pharma Limited CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 65862-191_62700754-4b64-421a-89dd-736867287197 65862-191 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20080926 ANDA ANDA078643 Aurobindo Pharma Limited CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 65862-192_63ac6e3f-70bd-44e6-b53b-865c30278b44 65862-192 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Aurobindo Pharma Limited FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-193_63ac6e3f-70bd-44e6-b53b-865c30278b44 65862-193 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Aurobindo Pharma Limited FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-194_63ac6e3f-70bd-44e6-b53b-865c30278b44 65862-194 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Aurobindo Pharma Limited FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-198_823b1e6a-272f-4160-848c-b0810a87aad6 65862-198 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Aurobindo Pharma Limited GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65862-199_823b1e6a-272f-4160-848c-b0810a87aad6 65862-199 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Aurobindo Pharma Limited GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65862-200_823b1e6a-272f-4160-848c-b0810a87aad6 65862-200 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Aurobindo Pharma Limited GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65862-201_c95f7f82-e161-40ce-8cdc-6685f964933a 65862-201 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA090083 Aurobindo Pharma Limited LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65862-202_c95f7f82-e161-40ce-8cdc-6685f964933a 65862-202 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA090083 Aurobindo Pharma Limited LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65862-203_c95f7f82-e161-40ce-8cdc-6685f964933a 65862-203 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA090083 Aurobindo Pharma Limited LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65862-207_3969972c-82a4-4264-9057-3d1d13e26adf 65862-207 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20090917 ANDA ANDA079111 Aurobindo Pharma Limited RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 65862-207_f0ee925d-fab9-49dd-8eb0-719ff2887531 65862-207 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20090917 ANDA ANDA079111 Aurobindo Pharma Limited RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 65862-208_ac33b105-4192-444a-bb34-8156de3bdc1c 65862-208 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride SOLUTION ORAL 20071128 ANDA ANDA078776 Aurobindo Pharma Limited ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 65862-209_f7328957-92f7-4b49-a27a-c69139157a3c 65862-209 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20080311 ANDA ANDA065470 Aurobindo Pharma Limited MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 65862-210_f7328957-92f7-4b49-a27a-c69139157a3c 65862-210 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20080311 ANDA ANDA065470 Aurobindo Pharma Limited MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 65862-211_f7328957-92f7-4b49-a27a-c69139157a3c 65862-211 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20080311 ANDA ANDA065470 Aurobindo Pharma Limited MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 65862-214_48947821-208a-47de-a5f7-1b26020da043 65862-214 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080606 ANDA ANDA078829 Aurobindo Pharma Limited ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 65862-215_48947821-208a-47de-a5f7-1b26020da043 65862-215 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080606 ANDA ANDA078829 Aurobindo Pharma Limited ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 65862-218_2e9ad045-7eaa-49a7-ac63-cdc0f87549be 65862-218 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20071214 ANDA ANDA065473 Aurobindo Pharma Limited CEFDINIR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-219_2e9ad045-7eaa-49a7-ac63-cdc0f87549be 65862-219 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20071214 ANDA ANDA065473 Aurobindo Pharma Limited CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-224_86e3b025-21ce-4302-8c1d-1e106ed752e2 65862-224 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride SOLUTION, CONCENTRATE ORAL 20081031 ANDA ANDA078861 Aurobindo Pharma Limited SERTRALINE HYDROCHLORIDE 20 mg/mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-225_0333bbc9-190e-4e2c-adc5-1cbd0fddd1e2 65862-225 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20120725 ANDA ANDA065489 Aurobindo Pharma Limited CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 65862-226_0333bbc9-190e-4e2c-adc5-1cbd0fddd1e2 65862-226 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20120725 ANDA ANDA065489 Aurobindo Pharma Limited CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 65862-227_d5352e3f-7a8d-4884-a612-d1becf65b89a 65862-227 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078956 Aurobindo Pharma Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65862-228_d5352e3f-7a8d-4884-a612-d1becf65b89a 65862-228 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078956 Aurobindo Pharma Limited LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65862-229_d5352e3f-7a8d-4884-a612-d1becf65b89a 65862-229 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078956 Aurobindo Pharma Limited LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65862-230_d5352e3f-7a8d-4884-a612-d1becf65b89a 65862-230 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078956 Aurobindo Pharma Limited LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65862-245_410e9687-af39-4e03-855e-2614c100f32a 65862-245 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Aurobindo Pharma Limited LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65862-246_410e9687-af39-4e03-855e-2614c100f32a 65862-246 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Aurobindo Pharma Limited LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65862-247_410e9687-af39-4e03-855e-2614c100f32a 65862-247 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Aurobindo Pharma Limited LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65862-248_9e63b926-d23c-49ef-9bcc-1a70a68e4d44 65862-248 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate SOLUTION ORAL 20120403 ANDA ANDA079062 Aurobindo Pharma Limited ESCITALOPRAM OXALATE 5 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-249_32757cd4-51bf-4c3f-8af1-810a28555de5 65862-249 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120830 ANDA ANDA079060 Aurobindo Pharma Limited ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 65862-250_dbc98296-6e30-4f46-b1a3-7308cafc6f69 65862-250 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090115 ANDA ANDA079063 Aurobindo Pharma Limited LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65862-286_5fa4a497-7996-4c99-8220-11b17d2f4fc4 65862-286 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA079070 Aurobindo Pharma Limited PERINDOPRIL ERBUMINE 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-286_d9033965-7cf5-41ef-9efa-d2eec745b43d 65862-286 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA079070 Aurobindo Pharma Limited PERINDOPRIL ERBUMINE 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-287_5fa4a497-7996-4c99-8220-11b17d2f4fc4 65862-287 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA079070 Aurobindo Pharma Limited PERINDOPRIL ERBUMINE 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-287_d9033965-7cf5-41ef-9efa-d2eec745b43d 65862-287 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA079070 Aurobindo Pharma Limited PERINDOPRIL ERBUMINE 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-288_5fa4a497-7996-4c99-8220-11b17d2f4fc4 65862-288 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA079070 Aurobindo Pharma Limited PERINDOPRIL ERBUMINE 8 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-288_d9033965-7cf5-41ef-9efa-d2eec745b43d 65862-288 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA079070 Aurobindo Pharma Limited PERINDOPRIL ERBUMINE 8 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-290_1a576ac9-28f3-44ef-aa51-e7068429891d 65862-290 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin CAPSULE ORAL 20090917 ANDA ANDA079117 Aurobindo Pharma Limited RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 65862-290_553bf5c0-4cea-4eed-967b-564d79b11817 65862-290 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin CAPSULE ORAL 20090917 ANDA ANDA079117 Aurobindo Pharma Limited RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 65862-291_09d7c48d-23e6-4394-8d27-3bf9cab5b887 65862-291 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120720 ANDA ANDA079118 Aurobindo Pharma Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65862-292_09d7c48d-23e6-4394-8d27-3bf9cab5b887 65862-292 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120720 ANDA ANDA079118 Aurobindo Pharma Limited METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 65862-299_25116e6a-3fe3-4e17-a594-9aa2d417a4f6 65862-299 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20090918 ANDA ANDA079150 Aurobindo Pharma Limited FLUCONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 65862-300_25116e6a-3fe3-4e17-a594-9aa2d417a4f6 65862-300 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20090918 ANDA ANDA079150 Aurobindo Pharma Limited FLUCONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 65862-306_9d80aa78-487a-4e01-9e2f-4bd724d40314 65862-306 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine SOLUTION ORAL 20090319 ANDA ANDA079209 Aurobindo Pharma Limited FLUOXETINE HYDROCHLORIDE 20 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-308_6a77c6bd-7369-460e-b9cf-ad920eddd2b2 65862-308 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20090709 ANDA ANDA079245 Aurobindo Pharma Limited FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-309_6a77c6bd-7369-460e-b9cf-ad920eddd2b2 65862-309 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20090709 ANDA ANDA079245 Aurobindo Pharma Limited FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-310_d065d7cf-bc3e-4c46-b63c-2544c8d25b6d 65862-310 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE ORAL 20080924 ANDA ANDA090094 Aurobindo Pharma Limited DIDANOSINE 125 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 65862-311_d065d7cf-bc3e-4c46-b63c-2544c8d25b6d 65862-311 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE ORAL 20080924 ANDA ANDA090094 Aurobindo Pharma Limited DIDANOSINE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 65862-312_d065d7cf-bc3e-4c46-b63c-2544c8d25b6d 65862-312 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE ORAL 20080924 ANDA ANDA090094 Aurobindo Pharma Limited DIDANOSINE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 65862-313_d065d7cf-bc3e-4c46-b63c-2544c8d25b6d 65862-313 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE ORAL 20080924 ANDA ANDA090094 Aurobindo Pharma Limited DIDANOSINE 400 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 65862-315_410e9687-af39-4e03-855e-2614c100f32a 65862-315 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Aurobindo Pharma Limited LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65862-325_ba6ba944-03d3-4ec0-9c6e-15a04044ea40 65862-325 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20130918 ANDA ANDA090056 Aurobindo Pharma Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 65862-326_ba6ba944-03d3-4ec0-9c6e-15a04044ea40 65862-326 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20130918 ANDA ANDA090056 Aurobindo Pharma Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 65862-327_2a2c0447-204a-4311-b8cd-c015bac68991 65862-327 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA090124 Aurobindo Pharma Limited ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 65862-328_2a2c0447-204a-4311-b8cd-c015bac68991 65862-328 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA090124 Aurobindo Pharma Limited ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 65862-329_2a2c0447-204a-4311-b8cd-c015bac68991 65862-329 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA090124 Aurobindo Pharma Limited ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 65862-357_eaa15c95-c638-4904-a844-c6788d502437 65862-357 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA090540 Aurobindo Pharma Limited CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 65862-361_561488a2-779a-49ef-97d3-12f00e319109 65862-361 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20091104 ANDA ANDA090401 Aurobindo Pharma Limited LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65862-362_561488a2-779a-49ef-97d3-12f00e319109 65862-362 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20091104 ANDA ANDA090401 Aurobindo Pharma Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65862-373_88faed43-71bb-41f0-8e2d-b6a99c5a2b33 65862-373 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA090432 Aurobindo Pharma Limited ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-374_88faed43-71bb-41f0-8e2d-b6a99c5a2b33 65862-374 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA090432 Aurobindo Pharma Limited ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-375_88faed43-71bb-41f0-8e2d-b6a99c5a2b33 65862-375 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA090432 Aurobindo Pharma Limited ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-390_be479614-572b-4667-b4fd-c9873e84e498 65862-390 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 Aurobindo Pharma Limited ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 65862-391_be479614-572b-4667-b4fd-c9873e84e498 65862-391 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 Aurobindo Pharma Limited ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 65862-402_2eedee65-36fc-47bd-b2e2-ae4f3800cf79 65862-402 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110421 ANDA ANDA090554 Aurobindo Pharma Limited DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65862-403_2eedee65-36fc-47bd-b2e2-ae4f3800cf79 65862-403 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110421 ANDA ANDA090554 Aurobindo Pharma Limited DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65862-404_a3368683-b276-4928-be2b-54eaa78460e5 65862-404 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine hydrochloride TABLET ORAL 20100407 ANDA ANDA090555 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-405_a3368683-b276-4928-be2b-54eaa78460e5 65862-405 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine hydrochloride TABLET ORAL 20100407 ANDA ANDA090555 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-406_a3368683-b276-4928-be2b-54eaa78460e5 65862-406 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine hydrochloride TABLET ORAL 20100407 ANDA ANDA090555 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-407_a3368683-b276-4928-be2b-54eaa78460e5 65862-407 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine hydrochloride TABLET ORAL 20100407 ANDA ANDA090555 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-408_a3368683-b276-4928-be2b-54eaa78460e5 65862-408 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine hydrochloride TABLET ORAL 20100407 ANDA ANDA090555 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-419_1183c243-7184-4bf9-bda2-a276af5f1439 65862-419 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Aurobindo Pharma Limited SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 65862-419_e90faa5a-408f-424d-afed-3e18a2444386 65862-419 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Aurobindo Pharma Limited SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 65862-420_1183c243-7184-4bf9-bda2-a276af5f1439 65862-420 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Aurobindo Pharma Limited SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 65862-420_e90faa5a-408f-424d-afed-3e18a2444386 65862-420 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Aurobindo Pharma Limited SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 65862-422_7c93cda5-d5c5-45af-b5cd-cdb63870808a 65862-422 HUMAN OTC DRUG Childrens Cetirizine Hydrochloride Allergy Cetirizine Hydrochloride SOLUTION ORAL 20100202 ANDA ANDA090750 Aurobindo Pharma Limited CETIRIZINE HYDROCHLORIDE 1 mg/mL 65862-431_b4cf6038-8de3-4b46-9b9f-1c6ec445bd20 65862-431 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine Hydrochloride SYRUP ORAL 20100728 ANDA ANDA090623 Aurobindo Pharma Limited RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 65862-443_2474de7e-aff1-473e-9adf-8ec07b5a3dc1 65862-443 HUMAN OTC DRUG Childrens Cetirizine Hydrochloride Hives Relief Cetirizine Hydrochloride SOLUTION ORAL 20100202 ANDA ANDA090750 Aurobindo Pharma Limited CETIRIZINE HYDROCHLORIDE 1 mg/mL 65862-448_b116863c-75b3-45d5-8013-a28211c799bd 65862-448 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Aurobindo Pharma Limited VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 65862-449_b116863c-75b3-45d5-8013-a28211c799bd 65862-449 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Aurobindo Pharma Limited VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 65862-451_339493b1-b80d-453a-bd2c-c4541d55ee18 65862-451 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Aurobindo Pharma Limited DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-452_339493b1-b80d-453a-bd2c-c4541d55ee18 65862-452 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Aurobindo Pharma Limited DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-453_339493b1-b80d-453a-bd2c-c4541d55ee18 65862-453 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Aurobindo Pharma Limited DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-454_0cd591b0-4ed1-44db-870e-4294ac984041 65862-454 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20110607 ANDA ANDA090871 Aurobindo Pharma Limited ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65862-455_0cd591b0-4ed1-44db-870e-4294ac984041 65862-455 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20110607 ANDA ANDA090871 Aurobindo Pharma Limited ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65862-456_0cd591b0-4ed1-44db-870e-4294ac984041 65862-456 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20110607 ANDA ANDA090871 Aurobindo Pharma Limited ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65862-457_0cd591b0-4ed1-44db-870e-4294ac984041 65862-457 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20110607 ANDA ANDA090871 Aurobindo Pharma Limited ALPRAZOLAM 3 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 65862-458_89845ba2-d240-4915-ad21-d3259ab81eca 65862-458 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20110329 ANDA ANDA090957 Aurobindo Pharma Limited GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 65862-459_89845ba2-d240-4915-ad21-d3259ab81eca 65862-459 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20110329 ANDA ANDA090957 Aurobindo Pharma Limited GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 65862-460_89845ba2-d240-4915-ad21-d3259ab81eca 65862-460 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20110329 ANDA ANDA090957 Aurobindo Pharma Limited GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 65862-465_540df288-bae8-462c-a8e5-950092d3ec69 65862-465 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA091114 Aurobindo Pharma Limited FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 65862-466_540df288-bae8-462c-a8e5-950092d3ec69 65862-466 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA091114 Aurobindo Pharma Limited FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 65862-467_540df288-bae8-462c-a8e5-950092d3ec69 65862-467 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA091114 Aurobindo Pharma Limited FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 65862-468_172c68e6-a902-4723-94fb-63ce6980c1cc 65862-468 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-469_172c68e6-a902-4723-94fb-63ce6980c1cc 65862-469 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-470_172c68e6-a902-4723-94fb-63ce6980c1cc 65862-470 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-471_b1c86ca7-9169-43a3-b167-214bb5306f29 65862-471 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20110330 ANDA ANDA091163 Aurobindo Pharma Limited FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-472_b1c86ca7-9169-43a3-b167-214bb5306f29 65862-472 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20110330 ANDA ANDA091163 Aurobindo Pharma Limited FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-473_b1c86ca7-9169-43a3-b167-214bb5306f29 65862-473 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20110330 ANDA ANDA091163 Aurobindo Pharma Limited FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-474_93e51728-9b2a-40cd-a559-0f401bb4895c 65862-474 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Aurobindo Pharma Limited RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-475_93e51728-9b2a-40cd-a559-0f401bb4895c 65862-475 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Aurobindo Pharma Limited RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-476_93e51728-9b2a-40cd-a559-0f401bb4895c 65862-476 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Aurobindo Pharma Limited RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-477_93e51728-9b2a-40cd-a559-0f401bb4895c 65862-477 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Aurobindo Pharma Limited RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-489_a423e921-4280-45dc-be41-a0d65909b1e1 65862-489 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Aurobindo Pharma Limited QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 65862-490_a423e921-4280-45dc-be41-a0d65909b1e1 65862-490 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Aurobindo Pharma Limited QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 65862-491_a423e921-4280-45dc-be41-a0d65909b1e1 65862-491 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Aurobindo Pharma Limited QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 65862-492_a423e921-4280-45dc-be41-a0d65909b1e1 65862-492 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Aurobindo Pharma Limited QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] 65862-493_a423e921-4280-45dc-be41-a0d65909b1e1 65862-493 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Aurobindo Pharma Limited QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 65862-494_a423e921-4280-45dc-be41-a0d65909b1e1 65862-494 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Aurobindo Pharma Limited QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 65862-495_a423e921-4280-45dc-be41-a0d65909b1e1 65862-495 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Aurobindo Pharma Limited QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 65862-496_87582e1f-4f11-42d5-930f-48f4ddd216a3 65862-496 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 20100608 ANDA ANDA091348 Aurobindo Pharma Limited SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 65862-501_60800334-a01c-455c-ba18-829315315244 65862-501 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091569 Aurobindo Pharma Limited AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 65862-502_60800334-a01c-455c-ba18-829315315244 65862-502 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091569 Aurobindo Pharma Limited AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 65862-503_60800334-a01c-455c-ba18-829315315244 65862-503 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091568 Aurobindo Pharma Limited AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 65862-512_0a0e8c4c-772e-41fd-98ae-c1c220c3c1cb 65862-512 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130213 ANDA ANDA200268 Aurobindo Pharma Limited PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 65862-513_0a0e8c4c-772e-41fd-98ae-c1c220c3c1cb 65862-513 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130213 ANDA ANDA200268 Aurobindo Pharma Limited PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 65862-514_0a0e8c4c-772e-41fd-98ae-c1c220c3c1cb 65862-514 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130213 ANDA ANDA200268 Aurobindo Pharma Limited PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 65862-515_d0071aa7-19ea-49f9-a565-03be60ef9f28 65862-515 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20111031 ANDA ANDA200629 Aurobindo Pharma Limited NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65862-516_d0071aa7-19ea-49f9-a565-03be60ef9f28 65862-516 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20111031 ANDA ANDA200629 Aurobindo Pharma Limited NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65862-520_09b30856-5eb2-4a58-8fe9-e2487e4db5c3 65862-520 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20111108 ANDA ANDA200429 Aurobindo Pharma Limited NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65862-521_09b30856-5eb2-4a58-8fe9-e2487e4db5c3 65862-521 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20111108 ANDA ANDA200429 Aurobindo Pharma Limited NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65862-522_09b30856-5eb2-4a58-8fe9-e2487e4db5c3 65862-522 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20111108 ANDA ANDA200429 Aurobindo Pharma Limited NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65862-523_f0fa819e-c736-429d-9d99-ad08dd7cb3b0 65862-523 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111006 ANDA ANDA200651 Aurobindo Pharma Limited GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65862-524_f0fa819e-c736-429d-9d99-ad08dd7cb3b0 65862-524 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111006 ANDA ANDA200651 Aurobindo Pharma Limited GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65862-525_09c496a0-7f0c-40d2-8f21-feae59aa1fb7 65862-525 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride and Metformin Hydrochloride Pioglitazone Hydrochloride and Metformin Hydrochloride TABLET, FILM COATED ORAL 20130213 ANDA ANDA200823 Aurobindo Pharma Limited METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 65862-526_09c496a0-7f0c-40d2-8f21-feae59aa1fb7 65862-526 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride and Metformin Hydrochloride Pioglitazone Hydrochloride and Metformin Hydrochloride TABLET, FILM COATED ORAL 20130213 ANDA ANDA200823 Aurobindo Pharma Limited METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850; 15 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 65862-527_4cda48b7-bd17-4220-939e-4ef5c2b5ad1c 65862-527 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA200834 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-528_4cda48b7-bd17-4220-939e-4ef5c2b5ad1c 65862-528 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA200834 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-533_9660a38f-66b4-4288-8ba9-ba903e5ff97c 65862-533 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 Aurobindo Pharma Limited AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 65862-534_9660a38f-66b4-4288-8ba9-ba903e5ff97c 65862-534 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 Aurobindo Pharma Limited AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 65862-535_d8f3701a-e494-4671-8077-436241a6c31c 65862-535 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201091 Aurobindo Pharma Limited AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 65862-536_9aad5ace-c0ba-4a68-a3a4-399c9e633bfd 65862-536 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Aurobindo Pharma Limited LEVOFLOXACIN 250 mg/1 65862-537_9aad5ace-c0ba-4a68-a3a4-399c9e633bfd 65862-537 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Aurobindo Pharma Limited LEVOFLOXACIN 500 mg/1 65862-538_9aad5ace-c0ba-4a68-a3a4-399c9e633bfd 65862-538 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Aurobindo Pharma Limited LEVOFLOXACIN 750 mg/1 65862-547_d8c0769c-a05a-4a39-8584-4cdb99698ce1 65862-547 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-548_d8c0769c-a05a-4a39-8584-4cdb99698ce1 65862-548 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-549_d8c0769c-a05a-4a39-8584-4cdb99698ce1 65862-549 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-550_d8c0769c-a05a-4a39-8584-4cdb99698ce1 65862-550 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-551_d8c0769c-a05a-4a39-8584-4cdb99698ce1 65862-551 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-552_4fc69d11-eba7-43eb-86aa-474e86930217 65862-552 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20111117 ANDA ANDA202032 Aurobindo Pharma Limited LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 65862-553_4fc69d11-eba7-43eb-86aa-474e86930217 65862-553 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20111117 ANDA ANDA202032 Aurobindo Pharma Limited LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 65862-554_7902fe40-154c-45f3-ae2b-f5fe7f02e267 65862-554 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121119 ANDA ANDA202261 Aurobindo Pharma Limited MINOCYCLINE HYDROCHLORIDE 45 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 65862-556_7902fe40-154c-45f3-ae2b-f5fe7f02e267 65862-556 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121119 ANDA ANDA202261 Aurobindo Pharma Limited MINOCYCLINE HYDROCHLORIDE 90 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 65862-558_7902fe40-154c-45f3-ae2b-f5fe7f02e267 65862-558 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121119 ANDA ANDA202261 Aurobindo Pharma Limited MINOCYCLINE HYDROCHLORIDE 135 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 65862-559_2fb32ea7-852b-498f-a412-d1e7a146b655 65862-559 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20120928 ANDA ANDA202038 Aurobindo Pharma Limited PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 65862-560_2fb32ea7-852b-498f-a412-d1e7a146b655 65862-560 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20120928 ANDA ANDA202038 Aurobindo Pharma Limited PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 65862-561_2737c30d-f7be-42e7-a40f-86c94af8825d 65862-561 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Aurobindo Pharma Limited OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 65862-562_2737c30d-f7be-42e7-a40f-86c94af8825d 65862-562 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Aurobindo Pharma Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 65862-563_2737c30d-f7be-42e7-a40f-86c94af8825d 65862-563 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Aurobindo Pharma Limited OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 65862-564_2737c30d-f7be-42e7-a40f-86c94af8825d 65862-564 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Aurobindo Pharma Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 65862-565_2737c30d-f7be-42e7-a40f-86c94af8825d 65862-565 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Aurobindo Pharma Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 65862-566_2737c30d-f7be-42e7-a40f-86c94af8825d 65862-566 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Aurobindo Pharma Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 65862-567_21680fbc-e356-4a05-936b-14b39c3c555a 65862-567 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA202096 Aurobindo Pharma Limited MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 65862-568_21680fbc-e356-4a05-936b-14b39c3c555a 65862-568 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA202096 Aurobindo Pharma Limited MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 65862-574_704c332a-264d-4ae8-b650-efa50eb03803 65862-574 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA202468 Aurobindo Pharma Limited MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 65862-579_9f57c6f6-4450-4c57-abac-1f35776cd8cf 65862-579 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120629 ANDA ANDA202759 Aurobindo Pharma Limited GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 65862-580_9f57c6f6-4450-4c57-abac-1f35776cd8cf 65862-580 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120629 ANDA ANDA202759 Aurobindo Pharma Limited GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 65862-581_9f57c6f6-4450-4c57-abac-1f35776cd8cf 65862-581 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120629 ANDA ANDA202759 Aurobindo Pharma Limited GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 65862-582_fa5b1054-846d-45be-b727-e9b8263ad2aa 65862-582 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Aurobindo Pharma Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 65862-583_fa5b1054-846d-45be-b727-e9b8263ad2aa 65862-583 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Aurobindo Pharma Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 65862-584_fa5b1054-846d-45be-b727-e9b8263ad2aa 65862-584 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Aurobindo Pharma Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 65862-585_fa5b1054-846d-45be-b727-e9b8263ad2aa 65862-585 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Aurobindo Pharma Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 65862-586_fa5b1054-846d-45be-b727-e9b8263ad2aa 65862-586 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Aurobindo Pharma Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 65862-587_fa5b1054-846d-45be-b727-e9b8263ad2aa 65862-587 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Aurobindo Pharma Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 65862-594_808d9596-30cc-4768-b648-1325b84afbe9 65862-594 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140602 ANDA ANDA202419 Aurobindo Pharma Limited DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65862-595_808d9596-30cc-4768-b648-1325b84afbe9 65862-595 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140602 ANDA ANDA202419 Aurobindo Pharma Limited DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65862-596_ddb57a16-8ba1-4ce3-9924-d83e93716daf 65862-596 HUMAN PRESCRIPTION DRUG Clindamycin Palmitate Hydrochloride (Pediatric) Clindamycin Palmitate Hydrochloride (Pediatric) SOLUTION ORAL 20130430 ANDA ANDA202409 Aurobindo Pharma Limited CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 65862-597_1a123145-2d63-484a-a0a0-061890796137 65862-597 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20120515 ANDA ANDA202418 Aurobindo Pharma Limited LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 65862-598_5d7dbb14-5657-4072-906d-c2253373718f 65862-598 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130430 ANDA ANDA202433 Aurobindo Pharma Limited TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 65862-599_d721ceaf-782a-43d7-a5f2-9e827bcfd554 65862-599 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20121231 ANDA ANDA202490 Aurobindo Pharma Limited RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 65862-600_d721ceaf-782a-43d7-a5f2-9e827bcfd554 65862-600 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20121231 ANDA ANDA202490 Aurobindo Pharma Limited RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 65862-601_54404a81-d9d8-4f43-a754-6c37179a40e2 65862-601 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20120927 ANDA ANDA202566 Aurobindo Pharma Limited MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 65862-602_54404a81-d9d8-4f43-a754-6c37179a40e2 65862-602 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20120927 ANDA ANDA202566 Aurobindo Pharma Limited MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 65862-603_d6789c17-4a2f-4519-9060-e3b0dba422f0 65862-603 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride TABLET, FILM COATED ORAL 20140304 ANDA ANDA202632 Aurobindo Pharma Limited MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 65862-604_603be0f7-0e08-41bf-9c8b-a605cff50653 65862-604 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Aurobindo Pharma Limited PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65862-605_603be0f7-0e08-41bf-9c8b-a605cff50653 65862-605 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Aurobindo Pharma Limited PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65862-606_603be0f7-0e08-41bf-9c8b-a605cff50653 65862-606 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Aurobindo Pharma Limited PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65862-607_603be0f7-0e08-41bf-9c8b-a605cff50653 65862-607 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Aurobindo Pharma Limited PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65862-608_603be0f7-0e08-41bf-9c8b-a605cff50653 65862-608 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Aurobindo Pharma Limited PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65862-609_603be0f7-0e08-41bf-9c8b-a605cff50653 65862-609 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Aurobindo Pharma Limited PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 65862-617_00efb2cd-607c-4b40-88a0-9ab51ec75500 65862-617 HUMAN PRESCRIPTION DRUG Quinapril Quinapril Hydrochloride TABLET, FILM COATED ORAL 20130429 ANDA ANDA202725 Aurobindo Pharma Limited QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-618_00efb2cd-607c-4b40-88a0-9ab51ec75500 65862-618 HUMAN PRESCRIPTION DRUG Quinapril Quinapril Hydrochloride TABLET, FILM COATED ORAL 20130429 ANDA ANDA202725 Aurobindo Pharma Limited QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-619_00efb2cd-607c-4b40-88a0-9ab51ec75500 65862-619 HUMAN PRESCRIPTION DRUG Quinapril Quinapril Hydrochloride TABLET, FILM COATED ORAL 20130429 ANDA ANDA202725 Aurobindo Pharma Limited QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-620_00efb2cd-607c-4b40-88a0-9ab51ec75500 65862-620 HUMAN PRESCRIPTION DRUG Quinapril Quinapril Hydrochloride TABLET, FILM COATED ORAL 20130429 ANDA ANDA202725 Aurobindo Pharma Limited QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 65862-625_a8e37688-426c-4290-933d-54a34ae86000 65862-625 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA203062 Aurobindo Pharma Limited RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 65862-626_a8e37688-426c-4290-933d-54a34ae86000 65862-626 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA203062 Aurobindo Pharma Limited RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 65862-629_542818a0-6e21-4d62-97cd-bcb6295d0cbc 65862-629 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130222 ANDA ANDA203630 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-630_542818a0-6e21-4d62-97cd-bcb6295d0cbc 65862-630 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130222 ANDA ANDA203630 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 65862-637_d8cd85d0-a301-4e78-8ba7-d90b182a53e2 65862-637 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA203081 Aurobindo Pharma Limited IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65862-638_d8cd85d0-a301-4e78-8ba7-d90b182a53e2 65862-638 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA203081 Aurobindo Pharma Limited IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65862-639_d8cd85d0-a301-4e78-8ba7-d90b182a53e2 65862-639 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA203081 Aurobindo Pharma Limited IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 65862-656_4d768cfe-3b20-4127-95b9-b4151b28afcc 65862-656 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140515 ANDA ANDA203708 Aurobindo Pharma Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 65862-657_4d768cfe-3b20-4127-95b9-b4151b28afcc 65862-657 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140515 ANDA ANDA203708 Aurobindo Pharma Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 65862-658_4d768cfe-3b20-4127-95b9-b4151b28afcc 65862-658 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140515 ANDA ANDA203708 Aurobindo Pharma Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 65862-659_4d768cfe-3b20-4127-95b9-b4151b28afcc 65862-659 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140515 ANDA ANDA203708 Aurobindo Pharma Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 65862-667_f479c5b3-1042-4bee-96a1-e30cd2809bfe 65862-667 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED ORAL 20140331 ANDA ANDA203494 Aurobindo Pharma Limited TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 65862-670_68064989-47ea-4ed5-a20e-43c4ef6ec271 65862-670 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20140122 ANDA ANDA203820 Aurobindo Pharma Limited REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 65862-671_68064989-47ea-4ed5-a20e-43c4ef6ec271 65862-671 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20140122 ANDA ANDA203820 Aurobindo Pharma Limited REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 65862-672_68064989-47ea-4ed5-a20e-43c4ef6ec271 65862-672 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20140122 ANDA ANDA203820 Aurobindo Pharma Limited REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 65862-673_dd39c559-5c5d-4d3b-9228-c44085e1699f 65862-673 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130117 ANDA ANDA203417 Aurobindo Pharma Limited FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 65862-674_dd39c559-5c5d-4d3b-9228-c44085e1699f 65862-674 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130117 ANDA ANDA203417 Aurobindo Pharma Limited FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 65862-675_dd39c559-5c5d-4d3b-9228-c44085e1699f 65862-675 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130117 ANDA ANDA203417 Aurobindo Pharma Limited FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 65862-686_40200a6c-bd2f-4f8a-aad3-fc09cc9dfeb3 65862-686 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20131105 20150930 ANDA ANDA203687 Aurobindo Pharma Limited FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 65862-697_4cda48b7-bd17-4220-939e-4ef5c2b5ad1c 65862-697 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111123 ANDA ANDA200834 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 65862-698_a4da74a2-7a57-4e07-a8cb-6e4e57f41fb5 65862-698 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 Aurobindo Pharma Limited CEFUROXIME AXETIL 125 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-699_a4da74a2-7a57-4e07-a8cb-6e4e57f41fb5 65862-699 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 Aurobindo Pharma Limited CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-700_a4da74a2-7a57-4e07-a8cb-6e4e57f41fb5 65862-700 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 Aurobindo Pharma Limited CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 65862-706_234d0dfc-cb24-413f-b798-129c73eb848e 65862-706 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20140915 ANDA ANDA204030 Aurobindo Pharma Limited AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 65862-707_234d0dfc-cb24-413f-b798-129c73eb848e 65862-707 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20140915 ANDA ANDA204030 Aurobindo Pharma Limited AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 65862-927_40200a6c-bd2f-4f8a-aad3-fc09cc9dfeb3 65862-927 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20140920 ANDA ANDA203687 Aurobindo Pharma Limited FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 65862-959_2eedee65-36fc-47bd-b2e2-ae4f3800cf79 65862-959 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141024 ANDA ANDA090554 Aurobindo Pharma Limited DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 65864-001_273556b3-afbd-4db2-a118-d08198b08d83 65864-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19370101 UNAPPROVED MEDICAL GAS RCS Management Corporation OXYGEN 99 L/100L 65868-001_f2c58c37-d398-4521-9437-42f3c7735af1 65868-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Mercy Medical Center- Clinton dba Mercy Home Medical Equipment OXYGEN 99 L/100L 65903-171_8b291140-d4a3-4952-a404-1c0b008e3b2b 65903-171 HUMAN OTC DRUG UV Defense Fluid Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 H2O Plus TITANIUM DIOXIDE; ZINC OXIDE 11; 14 g/100mL; g/100mL 65903-185_33949022-7ab6-48c6-9932-b98bb77b10f5 65903-185 HUMAN OTC DRUG CC Fair/Light Titanium Dioxide CREAM TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 H2O Plus TITANIUM DIOXIDE 8.5 g/100mL 65903-186_33949022-7ab6-48c6-9932-b98bb77b10f5 65903-186 HUMAN OTC DRUG CC Light / MediumFair/Light Titanium Dioxide CREAM TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 H2O Plus TITANIUM DIOXIDE 8.5 g/100mL 65903-242_60b452e3-2135-45de-a1fa-18c5141a64d2 65903-242 HUMAN OTC DRUG Anti Acne Exfoliating Cleansing Pads Salicylic Acid SWAB TOPICAL 20080901 OTC MONOGRAPH FINAL part333D H2O Plus SALICYLIC ACID 10 uL/mL 65903-247_66d51ead-8eae-43d5-98a8-cde6ab9ac918 65903-247 HUMAN OTC DRUG Anti Acne Clarifying Face Wash Salicylic Acid GEL TOPICAL 20090401 OTC MONOGRAPH FINAL part358B H2O Plus SALICYLIC ACID 15 uL/mL 65903-250_85527fb2-ccec-4fbd-b0a7-c44eeeee018f 65903-250 HUMAN OTC DRUG WhiteWater Advanced Brightening WhiteWater Advanced Brightening SPF30 Homosalate,Oxybenzone,Octisalate,Avobenzone LOTION TOPICAL 20120301 OTC MONOGRAPH FINAL part352 H2O PLUS AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 8; 4; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 65903-270_064707b2-95bb-4409-8bc1-cfd4dad625f0 65903-270 HUMAN OTC DRUG Face Oasis Hydrating Face Oasis Hydrating SPF 30 Avobenzone,Homosalate,Octisalate,Oxybenzone LOTION TOPICAL 20120301 OTC MONOGRAPH FINAL part352 H2O PLUS AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 8; 4; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 65903-272_fd1b2bcb-ac4b-4c98-a752-a6e808c1f4a3 65903-272 HUMAN OTC DRUG Anti Acne Calming Corrector Salicylic Acid GEL TOPICAL 20100301 OTC MONOGRAPH FINAL part333D H2O Plus SALICYLIC ACID 15 uL/mL 65903-276_5a1f5f5e-7602-4493-a9dc-b7229f61692d 65903-276 HUMAN OTC DRUG Sea Results Line Resolution Sea Results Line Resolution SPF30 Avobenzone,Homosalate,Octisalate,Oxybenzone CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 H2O PLUS AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 8; 4; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 65903-295_c482c8a4-3e32-4950-969c-cc09a455ac2b 65903-295 HUMAN OTC DRUG Sea Pure Hydrating Sea Pure Hydrating SPF20 Titanium Dioxide LOTION TOPICAL 20100610 OTC MONOGRAPH FINAL part352 H2O PLUS TITANIUM DIOXIDE 40 uL/mL 65903-360_019738f9-6d73-4376-86c8-d1025bb9a62f 65903-360 HUMAN OTC DRUG Raspberry Guava Antibacterial ALCOHOL GEL TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part333E H2O Plus ALCOHOL 68 mL/100mL 65903-361_019738f9-6d73-4376-86c8-d1025bb9a62f 65903-361 HUMAN OTC DRUG Sea Marine Antibacterial ALCOHOL GEL TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part333E H2O Plus ALCOHOL 68 mL/100mL 65909-089_50e0768b-260a-0b95-8685-1095713008f7 65909-089 HUMAN PRESCRIPTION DRUG STRONTIUM CHLORIDE Sr-89 STRONTIUM CHLORIDE SR-89 INJECTION INTRAVENOUS 20030106 ANDA ANDA075941 BIO NUCLEONICS INC STRONTIUM CHLORIDE SR-89 1 mCi/mL 65912-110_ba926fe9-ed00-411e-92d4-b8e7ba9764b4 65912-110 HUMAN OTC DRUG Liquid Layer SPF 30 Titanium Dioxide EMULSION TOPICAL 20120509 OTC MONOGRAPH NOT FINAL part352 ELEMIS LIMITED TITANIUM DIOXIDE 2.8 mL/40mL 65912-436_72f1c42d-9276-4d27-be88-d9dffd99037e 65912-436 HUMAN OTC DRUG Soin Solaire Complete SPF30 Titanium Dioxide, .ALPHA.-TOCOPHEROL ACETATE, PANTHENOL, TOCOPHEROL, CALCIUM ASCORBATE, and CALCIUM THREONATE EMULSION TOPICAL 20120327 OTC MONOGRAPH NOT FINAL part352 ELEMIS LIMITED .ALPHA.-TOCOPHEROL ACETATE; CALCIUM ASCORBATE; CALCIUM THREONATE; PANTHENOL; TITANIUM DIOXIDE; TOCOPHEROL .5; .0085; .0005; .375; 3.5; .5 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL 65919-001_21cc6cc8-1528-434c-b851-61eb88e28bb0 65919-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20000601 UNAPPROVED MEDICAL GAS Clinical 1 Home Medical, Inc. OXYGEN 99 L/100L 65919-002_d8eca97b-a4ed-4d1a-a336-4b09dad1508c 65919-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20000601 UNAPPROVED MEDICAL GAS Clinical 1 Home Medical, Inc. NITROGEN 99 L/100L 65923-001_56ad4e64-6c4c-402c-b35e-17348247fc07 65923-001 HUMAN OTC DRUG Coralite ANTIBACTERIAL BANDAGE WITH NON STICK PAD BENZALKONIUM CHLORIDE PATCH TOPICAL 20140219 OTC MONOGRAPH NOT FINAL part333A UNITED EXCHANGE CORP BENZALKONIUM CHLORIDE .12 mg/100mg 65923-002_c0402b4a-db64-4e99-a981-29e603023006 65923-002 HUMAN OTC DRUG Coralite ALCOHOL PADS ISOPROPYL ALCOHOL LIQUID TOPICAL 20120114 OTC MONOGRAPH FINAL part333A UNITED EXCHANGE CORP. ISOPROPYL ALCOHOL 70 mg/100mg 65923-003_7cabd213-8446-4e6b-a204-9a6b213d2f01 65923-003 HUMAN OTC DRUG Family Care Hemorrhoidal Mineral oil OINTMENT TOPICAL 20141124 OTC MONOGRAPH FINAL part346 United Exchange Corp MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 749; 2.5 mg/100g; mg/100g; mg/100g 65923-004_76cd96fa-f9d8-4b01-8a97-f8218e524b8b 65923-004 HUMAN OTC DRUG FAMILY CARE BACITRACIN BACITRACIN OINTMENT TOPICAL 20120301 OTC MONOGRAPH FINAL part333B UNITED EXCHANGE CORP. BACITRACIN 500 [USP'U]/g 65923-005_d2cd70ba-6e8c-4cc2-8bfb-0e66dc243306 65923-005 HUMAN OTC DRUG FAMILY CARE CHILDRENS DECONGESTANT NOSE DROPS PHENYLEPHRINE HYDROCHLORIDE SOLUTION NASAL 20120110 OTC MONOGRAPH FINAL part341 UNITED EXCHANGE CORP PHENYLEPHRINE HYDROCHLORIDE 1.25 mg/mL 65923-006_86c884f5-70c9-480c-abb5-a8c8be8c8267 65923-006 HUMAN OTC DRUG FAMILY CARE ACNE TREATMENT BENZOYL PEROXIDE CREAM TOPICAL 20120207 OTC MONOGRAPH FINAL part333D UNITED EXCHANGE CORP. BENZOYL PEROXIDE 10 g/100g 65923-007_12fb6064-c3d4-4355-b6b3-0a93dbc5c95a 65923-007 HUMAN OTC DRUG FAMILY CARE TRIPLE ANTIBIOTIC PAIN RELIEF NEOMYCIN SULFATE OINTMENT TOPICAL 20120207 OTC MONOGRAPH FINAL part333B UNITED EXCHANGE CORP. NEOMYCIN SULFATE 3.5 mg/g 65923-008_4f4b6d04-acf9-488a-87b7-90453d516be4 65923-008 HUMAN OTC DRUG FAMILY CARE ULTRA STRENGTH PAIN RELIEF CAMPHOR, MENTHOL OINTMENT TOPICAL 20120214 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP. CAMPHOR (SYNTHETIC); MENTHOL 110; 110 mg/g; mg/g 65923-009_7c6a5eb5-fe38-4708-ae24-362499edd522 65923-009 HUMAN OTC DRUG FAMILY CARE HEMORRHOIDAL MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL OINTMENT TOPICAL 20120301 OTC MONOGRAPH FINAL part346 UNITED EXCHANGE CORP. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 140; 719; 2.5; 30 mg/g; mg/g; mg/g; mg/g 65923-010_2ae3fd7b-8630-49fb-ba13-b7c0f0c7a1e8 65923-010 HUMAN OTC DRUG Iodent Maximum Strength Oral Analgesic BENZOCAINE GEL TOPICAL 20130531 OTC MONOGRAPH NOT FINAL part356 United Exchange Corp BENZOCAINE 20 g/100g 65923-011_6fedc5b3-ca4a-46f3-a0ca-f0716acebab5 65923-011 HUMAN OTC DRUG Family Care Nasal Relief OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20130531 OTC MONOGRAPH FINAL part341 United Exchange Corp OXYMETAZOLINE HYDROCHLORIDE 5 g/100mL 65923-012_b9b4142f-f721-4e0b-b02b-156a9fdc96a9 65923-012 HUMAN OTC DRUG Family Care Thera Flex Menthol Glycol Salicylate Nonivamide Tocopherol Acetate PATCH TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. ALPHA-TOCOPHEROL ACETATE; GLYCOL SALICYLATE; MENTHOL; NONIVAMIDE .93; 4.66; 6.53; .01 mg/100mg; mg/100mg; mg/100mg; mg/100mg 65923-046_3aa9ddcd-a84a-4812-9724-db89ab987300 65923-046 HUMAN OTC DRUG Family Care Triple Antibiotic Neomycin, Bacitracin, Polymyxin B OINTMENT TOPICAL 20140619 OTC MONOGRAPH FINAL part333B United Exchange Corp. BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 65923-077_9dc2303f-9008-4a57-b351-e1b533812223 65923-077 HUMAN OTC DRUG SHOPKO ORIGINAL NASAL OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20120301 OTC MONOGRAPH FINAL part341 UNITED EXCHANGE CORP. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 65923-100_9b3d09c8-60c7-41e2-a500-30f72194f73d 65923-100 HUMAN OTC DRUG FAMILY CARE THERA FLEX PAIN CAPSAICIN, CAMPHOR, MENTHOL, METHYL SALICYLATE, PEPPERMINT OIL, ZINC OXIDE PATCH TOPICAL 20120930 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP CAMPHOR (SYNTHETIC); CAPSAICIN; MENTHOL; METHYL SALICYLATE; PEPPERMINT OIL; ZINC OXIDE 1.48; .0056; 3.95; 3.95; 1.95; 18.77 g/1; g/1; g/1; g/1; g/1; g/1 65923-101_90ba8d31-b29c-47de-b9b1-0d33f7aa788e 65923-101 HUMAN OTC DRUG Iodent Sensitive Fresh Mint Potassium nitrate and sodium floride PASTE DENTAL 20141023 OTC MONOGRAPH NOT FINAL part356 United Exchange Corp. POTASSIUM NITRATE; SODIUM FLUORIDE 5; .15 mg/100g; mg/100g 65923-102_510d34bc-cfdf-4d03-bbd8-a8f2c8f469ef 65923-102 HUMAN OTC DRUG Iodent Fluoride Regular Fluoride PASTE DENTAL 20141023 OTC MONOGRAPH FINAL part355 United Exchange Corp. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 65923-104_a954f3d9-06b6-48b1-acba-665286b5cf87 65923-104 HUMAN OTC DRUG Family Care Maximum Strength Medicated Anti Itch Menthol CREAM TOPICAL 20141124 OTC MONOGRAPH FINAL part346 United Exchange Corp MENTHOL; PRAMOXINE HYDROCHLORIDE 10; 10 mg/g; mg/g 65923-105_dee44102-ca4c-4552-aa1e-0c62a0be1115 65923-105 HUMAN OTC DRUG Iodent Sensitive Extra Whitening Sodium Fluoride Potassium Nitrate PASTE DENTAL 20141023 OTC MONOGRAPH NOT FINAL part356 United Exchange Corp. POTASSIUM NITRATE; SODIUM FLUORIDE 2.43; 5 mg/g; mg/g 65923-107_e84d391f-1723-4666-ac9f-f2b8b573954e 65923-107 HUMAN OTC DRUG Iodent Animal Kingdom Fruity Fluoride PASTE DENTAL 20140616 OTC MONOGRAPH FINAL part355 United Exchange Corp. SODIUM FLUORIDE .22 g/100g 65923-108_f011f94c-ec44-4a46-8563-bfc2a98a6475 65923-108 HUMAN OTC DRUG SoundBody Tolnaftate Antifungal Tolnaftate CREAM TOPICAL 20140226 OTC MONOGRAPH FINAL part333C United Exchange Corp. TOLNAFTATE 10 mg/g 65923-132_deb18773-7b20-4734-a595-20052304f477 65923-132 HUMAN OTC DRUG Coralite Antibacterial Triclocarban SOAP TOPICAL 20130904 OTC MONOGRAPH NOT FINAL part333A United Exchange Corp TRICLOCARBAN 2.6 g/10g 65923-133_dc3a0b28-0476-4505-9f65-e63851c13d18 65923-133 HUMAN OTC DRUG Coralite Antibacterial Natural Oat triclocarban SOAP TOPICAL 20130905 OTC MONOGRAPH NOT FINAL part333A United Exchange Corp TRICLOCARBAN 1.3 g/10g 65923-136_acf942c0-1f22-4726-b782-951cf0051e8b 65923-136 HUMAN OTC DRUG Nu Pore Acne Salicyilc acid CLOTH TOPICAL 20131204 OTC MONOGRAPH FINAL part333D United Exchange Corp. SALICYLIC ACID .05 mg/100mg 65923-139_536909dd-be68-4850-9ee8-c37b4137cd56 65923-139 HUMAN OTC DRUG SoundBody Clotrimazole Antifungal Clotrimazole CREAM TOPICAL 20140226 OTC MONOGRAPH FINAL part333C United Exchange Corp. CLOTRIMAZOLE 10 mg/g 65923-150_3880fc26-4265-42ec-a683-4d7f8dcbef09 65923-150 HUMAN OTC DRUG Coralite Pain Relief Menthol PATCH TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. MENTHOL 5 mg/g 65923-151_ad58ebd4-0035-45f3-8edc-d3defe4f3810 65923-151 HUMAN OTC DRUG Coralite Cold and Hot Menthol PATCH TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. MENTHOL 5 mg/g 65923-152_725e4b44-2fc6-4280-8962-17b24c9153d4 65923-152 HUMAN OTC DRUG Coralite Pain Relief Menthol Capsaicin PATCH TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. CAPSAICIN; MENTHOL 8.3; 30 mg/g; mg/g 65923-153_eb8758da-ee82-4610-abe9-3510a33e722e 65923-153 HUMAN OTC DRUG Coralite Cold and Hot Menthol PATCH TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. MENTHOL 5 mg/g 65923-155_48823b51-638b-463d-a92b-07da24c1dcc5 65923-155 HUMAN OTC DRUG Coralite Muscle Joint Camphor Menthol Menthyl Salicylate PATCH TOPICAL 20131211 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE .012; .057; .063 mg/100mg; mg/100mg; mg/100mg 65923-156_104a2663-244b-4043-b588-2d33fa611046 65923-156 HUMAN OTC DRUG Coralite Pain Relief DL-Camphor, L-Menthol, Methylsalicylate PATCH TOPICAL 20140326 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 1.2; 5.7; 6.3 g/100g; g/100g; g/100g 65923-181_07b03013-7264-4dc3-b4b2-bff11a29767f 65923-181 HUMAN OTC DRUG Idodent Flouride Mint Fluoride PASTE DENTAL 20141023 OTC MONOGRAPH FINAL part355 United Exchange Corp. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 65923-385_81fdbf83-21e6-4e28-b688-a17f686a69be 65923-385 HUMAN OTC DRUG Family Care Pain Relief DL-Camphor, L-Menthol, Methylsalicylate PATCH TOPICAL 20131126 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 1.2; 5.7; 6.3 g/100g; g/100g; g/100g 65923-387_95464e95-b6f8-4cf2-a805-092ff16a010c 65923-387 HUMAN OTC DRUG Assured Nasal Relief Oxymetazoline Hydrochloride SPRAY NASAL 20131120 OTC MONOGRAPH FINAL part341 United Exchange Corp. OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL 65923-472_55bd55b0-625c-4451-935a-13b6f9c1f498 65923-472 HUMAN OTC DRUG FAMILY CARE HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP. HYDROCORTISONE 1 g/100g 65923-492_18f3072a-07e0-4907-8825-6ff335775933 65923-492 HUMAN OTC DRUG Family Care Hydrocortisone Hydrocortisone OINTMENT TOPICAL 20141124 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. HYDROCORTISONE 1 g/100g 65923-495_bf06744c-d19e-49be-a34d-1c787367b51b 65923-495 HUMAN OTC DRUG Family Care Anti-Itch Diphenhydramine hydrochloride Zinc Acetate CREAM TOPICAL 20141124 OTC MONOGRAPH FINAL part347 United Exchange Corp. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1; .1 g/100g; g/100g 65923-496_850ba379-d32a-4bec-b718-5f6ecdf12383 65923-496 HUMAN OTC DRUG Family Care Bacitracin Anti-Infection Bacitracin OINTMENT TOPICAL 20141203 OTC MONOGRAPH FINAL part333B United Exchange Corp. BACITRACIN 500 [USP&apos'U]/g 65923-498_b3043a3d-89af-4a88-b709-9f08ca2249c1 65923-498 HUMAN OTC DRUG FAMILY CARE MUSCLE RUB PAIN RELIEVER MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20120930 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g 65923-502_08f8ed7f-2755-4650-87ab-1644d5858e3d 65923-502 HUMAN OTC DRUG Family Care Tolnaftate Tolnaftate CREAM TOPICAL 20130430 OTC MONOGRAPH FINAL part333C United Exchange Corp. TOLNAFTATE 10 mg/g 65923-505_283adf47-2c15-4fe6-ac04-d5a81a7155c1 65923-505 HUMAN OTC DRUG FAMILY CARE CLOTRIMAZOLE ANTIFUNGAL CLOTRIMAZOLE CREAM TOPICAL 20120501 OTC MONOGRAPH FINAL part333C United Exchange Corp. CLOTRIMAZOLE 1 g/100g 65923-510_8e016b49-13e5-49b1-843a-1f9e654ac908 65923-510 HUMAN OTC DRUG Family Care Original Eye TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION/ DROPS OPHTHALMIC 20141125 OTC MONOGRAPH FINAL part349 United Exchange Corp TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 65923-511_976d6fec-ea58-4eac-9f92-a47637a7cd79 65923-511 HUMAN OTC DRUG Family Care Advanced Formula Eye Tetrahydrozoline hydrochloride, dextran 70, polyethylene glycol 400, povidone SOLUTION/ DROPS OPHTHALMIC 20141125 OTC MONOGRAPH FINAL part349 United Exchange Corp DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL 65923-513_43d78cf5-1a1e-4a4f-b250-1a4c6baf88ff 65923-513 HUMAN OTC DRUG FAMILY CARE ANTIBIOTIC NEOMYCIN SULFATE OINTMENT TOPICAL 20121130 OTC MONOGRAPH FINAL part333B UNITED EXCHANGE CORP. NEOMYCIN SULFATE 3.5 mg/g 65923-514_28ab61f3-d5ce-4bad-9eab-39358158136d 65923-514 HUMAN OTC DRUG FAMILY CARE MUSCLE AND JOINT VANISHING SCENT MENTHOL GEL TOPICAL 20141124 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP. MENTHOL 2.5 g/100g 65923-523_21ec048b-3d74-42f5-9038-ab3a71445ed7 65923-523 HUMAN OTC DRUG Family Care Triple Antibiotic Plus Pain Relief Bacitracin Neomycin Sulfate Polymyxin B Sulfate Pramoxine Hydrochloride OINTMENT TOPICAL 20141124 OTC MONOGRAPH FINAL part333B United Exchange Corp. BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP&apos'U]/g; mg/g; [USP&apos'U]/g; mg/g 65923-532_e5718299-b96e-42bc-9a3d-30c54cc32059 65923-532 HUMAN OTC DRUG Coralite Ultra Strength Pain Relief Camphor Menthol OINTMENT TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. CAMPHOR (SYNTHETIC); MENTHOL 110; 110 mg/g; mg/g 65923-551_c4e866a6-8dd7-4695-97a0-5daccbe34f55 65923-551 HUMAN OTC DRUG Family Care Nasal Relief OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20130630 OTC MONOGRAPH FINAL part341 United Exchange Corp OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 65923-555_27548db5-0d29-485b-8e85-c75a0e112af8 65923-555 HUMAN OTC DRUG FAMILY CARE LUBRICANT SINGLE USE EYE CARBOXYMETHYLCELLULOSE SODIUM SOLUTION OPHTHALMIC 20130228 OTC MONOGRAPH FINAL part349 UNITED EXCHANGE CORP CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL 65923-557_709eba12-9d76-41ae-8362-453be1f62c2c 65923-557 HUMAN OTC DRUG Family Care Premium Saline Nasal Sodium chloride SOLUTION NASAL 20140602 OTC MONOGRAPH FINAL part349 United Exchange Corp SODIUM CHLORIDE .29 mg/44mL 65923-559_109d51b6-58e3-4dac-bff3-053e305c47c0 65923-559 HUMAN OTC DRUG Sound Body Original Eye Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20140519 OTC MONOGRAPH FINAL part349 United Exchange Corp TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/10mg 65923-565_256a32b9-d8bb-468f-8822-4862fd60f05c 65923-565 HUMAN OTC DRUG Sound Body Artificial Tears Polyvinyl alcohol, povidone SOLUTION/ DROPS OPHTHALMIC 20140225 OTC MONOGRAPH FINAL part349 United Exchange Corp. POLYVINYL ALCOHOL; POVIDONE 5; 6 mg/mL; mg/mL 65923-637_70332973-4a38-4a69-bab3-18c91a532664 65923-637 HUMAN OTC DRUG SoundBody Advanced Relief Dextarn 70, Polyethylene glycol 400, Povidone, Tetrahydrozoline HCI SOLUTION/ DROPS OPHTHALMIC 20141125 OTC MONOGRAPH FINAL part349 United Exchange Corp. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL 65923-644_dab231dc-834d-408c-ba82-a95a48f3ac7f 65923-644 HUMAN OTC DRUG SoundBody Long Lasting Lubricant Polyethylene glycol 400, Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20140226 OTC MONOGRAPH FINAL part349 United Exchange Corp. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL 65923-699_10e57f86-ebee-4705-9638-7b81f274b4a2 65923-699 HUMAN OTC DRUG SHOPKO HYDROCORTISONE WITH ALOE HYDROCORTISONE CREAM TOPICAL 20121231 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP HYDROCORTISONE 1 g/100g 65923-700_c6d8df9e-06a7-4266-9b22-cfd91172120b 65923-700 HUMAN OTC DRUG PAIN RELIEF THERAPY PATCH MENTHOL PATCH TOPICAL 20130131 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP MENTHOL 750 mg/1 65923-701_dc5263cb-36f2-4900-a769-4804b5b35b60 65923-701 HUMAN OTC DRUG Extra Strength Pain Relief Therapy Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp MENTHOL 750 mg/1 65923-702_9b8e9fe9-a33d-4ad7-bf20-2c74227d4cca 65923-702 HUMAN OTC DRUG Extra Strength Pain Relief Therapy Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp MENTHOL 750 mg/1 65923-703_9d4634b7-c635-45d3-b003-ad87af8fc4c6 65923-703 HUMAN OTC DRUG Extra Strength Pain Relief Therapy Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp MENTHOL 750 mg/1 65923-704_593b7c85-4c0c-48a9-a148-91a38a84c943 65923-704 HUMAN OTC DRUG Extra Strength Pain Relief Therapy Menthol PATCH TOPICAL 20140828 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp MENTHOL 750 mg/1 65923-777_7efa7bd4-6f86-46bf-9ebc-2ca3fcc88edc 65923-777 HUMAN OTC DRUG SHOPKO HEMORRHOIDAL MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL OINTMENT TOPICAL 20110321 OTC MONOGRAPH FINAL part346 UNITED EXCHANGE CORP. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 140; 719; 2.5; 30 mg/g; mg/g; mg/g; mg/g 65923-778_7c49c02b-3d97-4de7-8dc3-45b8a493a40c 65923-778 HUMAN OTC DRUG Shopko Hemorrhoidal Mineral Oil OINTMENT TOPICAL 20130630 OTC MONOGRAPH FINAL part346 United Exchange Corp MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 749; 2.5 mg/100g; mg/100g; mg/100g 65923-802_ab346b45-079f-48c4-94ec-1ccb12ffd229 65923-802 HUMAN OTC DRUG FAMILY CARE MEDICATED HEMORRHOIDAL WITCH HAZEL CLOTH TOPICAL 20110720 OTC MONOGRAPH FINAL part346 UNITED EXCHANGE CORPORATION WITCH HAZEL 5 g/1 65923-803_53e21456-c1f4-419f-856e-c27d26617327 65923-803 HUMAN OTC DRUG Family Care Pain Relief DL-Camphor,L-Menthol,Methyl Salicylate PATCH TOPICAL 20110920 OTC MONOGRAPH FINAL part348 United Exchange Corporation CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 1.2; 5.7; 6.3 g/100g; g/100g; g/100g 65923-807_4da68b98-6858-415e-850c-3ff2ef727ef6 65923-807 HUMAN OTC DRUG Coralite Ultra Antibacterial Deodorant TRICLOCARBAN SOAP TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part333A United Exchange Corp TRICLOCARBAN .3 g/100g 65923-831_4d439c48-8348-4de1-9cd4-b77c199adedb 65923-831 HUMAN OTC DRUG Coralite Antibacterial Moist Benzalkonium Chloride SOLUTION TOPICAL 20130926 OTC MONOGRAPH NOT FINAL part333A United Exchange Corp. BENZALKONIUM CHLORIDE .115 g/1 65923-901_44ebfbf1-aa96-491c-b3ef-19018d6856a4 65923-901 HUMAN OTC DRUG FAMILY CARE BACK PAIN THERAPY CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM OLEORESIN PATCH TOPICAL 20111227 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP CAMPHOR (SYNTHETIC); CAPSICUM OLEORESIN; MENTHOL 80; 16; 24 mg/1; mg/1; mg/1 65923-902_552b3beb-3130-4670-98a4-494f3df0c3c7 65923-902 HUMAN OTC DRUG FAMILY CARE MENTHOL RELIEF MENTHOL, METHYL SALICYLATE STICK TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP. MENTHOL; METHYL SALICYLATE 4; 1 g/100g; g/100g 65923-977_29fd623b-37fe-4e11-b5af-3559cfc0be2a 65923-977 HUMAN OTC DRUG SHOPKO EXTRA MOISTURIZING NASAL OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20120301 OTC MONOGRAPH FINAL part341 UNITED EXCHANGE CORP. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 65923-978_4b0980e0-b345-4c32-9458-cedb3b9224aa 65923-978 HUMAN OTC DRUG SHOPKO SEVERE CONGESTION NASAL OXYMETAZOLINE HCL SPRAY NASAL 20120301 OTC MONOGRAPH FINAL part341 UNITED EXCHANGE CORP. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 65952-575_bfe45b6f-c017-4514-9e29-6391641b92f6 65952-575 HUMAN OTC DRUG Sani Guard Alcohol Free BENZETHONIUM CHLORIDE LIQUID TOPICAL OTC MONOGRAPH NOT FINAL part333 DEM Technology, LLC BENZETHONIUM CHLORIDE 2 mg/mL 65954-002_ddb01802-192a-4338-9c6a-c21bae7df346 65954-002 HUMAN OTC DRUG Colgate Total Whitening Sodium Fluoride and Triclosan GEL, DENTIFRICE DENTAL 20091001 NDA NDA020231 Mission Hills, S.A. de C.V. SODIUM FLUORIDE; TRICLOSAN 2.4; 3 mg/g; mg/g 65954-003_57e6ce72-21c2-4eb4-88de-b03877bf0191 65954-003 HUMAN OTC DRUG Colgate Total Whitening Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20091001 NDA NDA020231 Mission Hills, S.A. de C.V. SODIUM FLUORIDE; TRICLOSAN 2.4; 3 mg/g; mg/g 65954-007_5b238118-7618-4de8-9426-a81418c86aa7 65954-007 HUMAN OTC DRUG Colgate Sparkling White Mint Zing SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110820 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 65954-007_7dda1560-4137-46dd-9e50-8110b003ee70 65954-007 HUMAN OTC DRUG Colgate Sparkling White Mint Zing SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110720 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g 65954-007_a94dbdfa-6e2a-4293-bb1b-8b250e8de0bc 65954-007 HUMAN OTC DRUG Colgate Sparkling White Mint Zing SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110820 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 65954-007_e8d21624-c8f2-4ef5-b4eb-94ea0875da99 65954-007 HUMAN OTC DRUG Colgate Sparkling White Mint Zing SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110820 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 65954-008_ae0ab2d7-be83-4307-9602-48739c8b8e34 65954-008 HUMAN OTC DRUG COLGATE SPARKLING WHITE CINNAMINT SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-010_b0f36912-2fc2-4f65-b72c-72255276ec13 65954-010 HUMAN OTC DRUG Colgate MaxFresh Fresh Mint SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20130108 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-013_a857ebc0-d4b8-431d-a8fb-037eb8a59637 65954-013 HUMAN OTC DRUG Colgate Max Fresh Clean Mint SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110801 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM FLUORIDE 1.1 mg/g 65954-014_e42ecebb-8634-4d73-adf4-a4244a804b7b 65954-014 HUMAN OTC DRUG Colgate Max Fresh Cool Mint SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110801 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-022_3c1317de-fd30-4a2e-97fd-0f96cd4b27b8 65954-022 HUMAN OTC DRUG Colgate Luminous Crystal Fluoride SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20091103 OTC MONOGRAPH FINAL part355 Mission Hills S.A. de C.V. SODIUM FLUORIDE 1.1 mg/g 65954-023_0ca4d1b9-2888-4fcc-a8b6-9728257ac1fa 65954-023 HUMAN OTC DRUG Colgate Fresh Mint SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20130508 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-036_3dc7fed9-18da-4638-9a99-4cd92222d52c 65954-036 HUMAN OTC DRUG COLGATE KIDS WATERMELON FLAVOR SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110726 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-037_15a6a29c-aa27-48a3-b256-41dd62faa9ea 65954-037 HUMAN OTC DRUG COLGATE KIDS 2IN1 STRAWBERRY SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110726 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-038_01fe7a1e-7d3f-4ea1-bae6-dd886531786b 65954-038 HUMAN OTC DRUG COLGATE 2IN1 WHITENING STAIN LIFTERS SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110726 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-041_043786ef-d0f0-49dd-9edb-40f9575925e0 65954-041 HUMAN OTC DRUG COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110726 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-042_35ef7565-f9d5-401f-aaad-b153ce9ea8ff 65954-042 HUMAN OTC DRUG Colgate Max White Crystal Mint SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20090127 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-044_e3fac013-0dfd-4914-9b62-651b5c8f3d01 65954-044 HUMAN OTC DRUG Colgate Sensitive Enamel Protect SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20101130 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.1 mg/g; mg/g 65954-046_32a2782e-4591-4edf-9015-7f2f5cbaa77d 65954-046 HUMAN OTC DRUG Colgate Sensitive Multiprotection SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20100112 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.1 mg/g; mg/g 65954-046_4aec6fb0-d3a3-4eee-93ff-f65a1a0d7fcb 65954-046 HUMAN OTC DRUG Colgate Sensitive Multiprotection SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20100621 OTC MONOGRAPH FINAL part355 Mission Hills S.A. de C.V. POTASSIUM NITRATE; SODIUM FLUORIDE 50; 2.4 mg/g; mg/g 65954-047_cec8e0bc-1503-4bdb-a02c-b54522c4166b 65954-047 HUMAN OTC DRUG Colgate Max White Polar Rush SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM FLUORIDE 2.4 mg/g 65954-049_dcae866b-a388-46cc-988d-6e5e271e58fd 65954-049 HUMAN OTC DRUG COLGATE SENSITIVE SMARTFOAM WITH WHITENING POTASSIUM NITRATE and SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130501 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.1 mg/g; mg/g 65954-060_cd8e2bd9-35b5-47be-a5e6-a4d4a6364d81 65954-060 HUMAN OTC DRUG COLGATE Great Regular Flavor SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20051105 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g 65954-062_eae85be7-a7c8-4fbe-be2e-63113feda71d 65954-062 HUMAN OTC DRUG Colgate MaxFresh CoolScrub Mintblast with Whitening SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20130522 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-063_2ebfd20c-fcbd-4c24-ad20-7ac2edbff539 65954-063 HUMAN OTC DRUG Colgate ULTRA BRITE Baking Soda and Peroxide Whitening SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 65954-064_4d84e665-c688-4092-9976-f509905d3b1a 65954-064 HUMAN OTC DRUG COLGATE ULTRA BRITE ADVANCED WHITENING ALL IN ONE CLEAN MINT SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20051105 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-065_118e71e6-a9fa-4799-8daa-78d903f23711 65954-065 HUMAN OTC DRUG Colgate Kids Mild Bubble Fruit Flavor SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110112 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-068_d02824b8-40c3-4997-9846-b9e3a8d80057 65954-068 HUMAN OTC DRUG Colgate Sparkling White Mint Zing SODIUM MONOFLUOROPHOSPHATE GEL, DENTIFRICE DENTAL 20130301 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g 65954-069_65bba2e3-f933-4d90-8f93-7c7df12464a3 65954-069 HUMAN OTC DRUG Colgate Turtles Mild Bubble Fruit SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130604 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-070_69c69489-2d8d-4385-8325-8b13245a96b9 65954-070 HUMAN OTC DRUG Colgate Monster High Mild Bubble Fruit SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130604 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-162_58a88630-447d-4bd0-b6c6-a23a85d29b5d 65954-162 HUMAN OTC DRUG Colgate Tartar Control Whitening Crisp Mint SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20110108 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-327_7a621e18-a8a4-4650-84df-86470a2e9101 65954-327 HUMAN OTC DRUG Colgate Junior Bubble Fruit SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-353_34312b6f-36d6-4352-8222-975b6a72b333 65954-353 HUMAN OTC DRUG Colgate Total Advanced Clean SODIUM FLUORIDE and TRICLOSAN PASTE, DENTIFRICE DENTAL 20090707 NDA NDA020231 Colgate-Palmolive Company SODIUM FLUORIDE; TRICLOSAN 2.4; 3 mg/g; mg/g 65954-354_08a0db89-03a1-4178-85bb-43ac057d3b30 65954-354 HUMAN OTC DRUG Colgate Total Advanced Clean SODIUM FLUORIDE and TRICLOSAN GEL, DENTIFRICE DENTAL 20090707 NDA NDA020231 Colgate-Palmolive Company SODIUM FLUORIDE; TRICLOSAN 2.4; 3 mg/g; mg/g 65954-355_3c8cb9db-9dc1-489e-b83b-e0750b5092f3 65954-355 HUMAN OTC DRUG COLGATE 2IN1 ICY BLAST SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110726 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-358_36f04289-797a-466a-b346-4b05c4f8ecce 65954-358 HUMAN OTC DRUG Colgate Sensitive Maximum Strength Whitening SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20110726 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A. de C.V. POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.1 mg/g; mg/g 65954-372_b7a458ae-3b71-4f12-ac17-6df6d927a14c 65954-372 HUMAN OTC DRUG COLGATE 2IN1 OXYGEN WHITENING COOL MINT FLUORIDE SODIUM MONOFLUOROPHOSPHATE GEL, DENTIFRICE DENTAL 20110726 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g 65954-381_4fc4a24d-a1af-4c9d-983c-460a07b7e1cb 65954-381 HUMAN OTC DRUG Colgate Max Clean Effervescent Mint SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110318 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-382_edcebd1a-c533-4b59-aae7-1be68435d603 65954-382 HUMAN OTC DRUG Colgate Max Clean Spearmint Blast SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110801 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-504_0ed9700c-f5c3-46d4-bcd6-8ee264024d4b 65954-504 HUMAN OTC DRUG Colgate Kids Halloween Wicked Watermelon SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110726 OTC MONOGRAPH FINAL part355 Mission Hills S.A. de C.V. SODIUM FLUORIDE 1.1 mg/g 65954-531_085af535-6ec3-4d4d-80a3-4e299f3dbb1d 65954-531 HUMAN OTC DRUG Colgate Junior Sponge Bob SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM FLUORIDE 1.1 mg/g 65954-534_8de3c2ea-e011-42d1-9add-19d9efd7b675 65954-534 HUMAN OTC DRUG Colgate Junior Dora SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM FLUORIDE 1.1 mg/g 65954-536_b4e581f5-03b5-4a46-8132-4325f424e731 65954-536 HUMAN OTC DRUG Colgate Triple Action SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20101201 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-538_20796620-2be2-4af7-a462-63f9e03cb3c6 65954-538 HUMAN OTC DRUG Colgate Winter Watermelon Flavor SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20121101 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-545_caf8de03-0b06-4636-89a9-e4dd833734a4 65954-545 HUMAN OTC DRUG Colgate Jr Littlest Pet Shop SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM FLUORIDE .24 mg/g 65954-547_5eff59e9-d140-4ba6-a3f8-7d4e935895c4 65954-547 HUMAN OTC DRUG Colgate Junior Transformers SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM FLUORIDE .24 mg/g 65954-548_2ff17e33-f2c0-4353-b474-7a0eb972628f 65954-548 HUMAN OTC DRUG Colgate Sensitive Pro Relief Whitening SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20100906 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.1 mg/g; mg/g 65954-549_206d36f2-755e-45da-b911-199919707c26 65954-549 HUMAN OTC DRUG Colgate Sensitive Pro Relief SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20100906 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.1 mg/g; mg/g 65954-552_5865db43-dc6f-4da4-a1f1-3c24ed65be33 65954-552 HUMAN OTC DRUG Colgate Optic White Sparkling Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20111208 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g 65954-553_6b419ae1-bf23-44c6-b8c0-a5afda8f5aa4 65954-553 HUMAN OTC DRUG Colgate Sensitive Pro Relief Enamel Repair SODIUM MONOFLUOROPHOSPHATE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20110112 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V POTASSIUM NITRATE; SODIUM MONOFLUOROPHOSPHATE 50; 1.5 mg/g; mg/g 65954-554_a19871fe-1e30-41f3-b98a-3906b3e86e4f 65954-554 HUMAN OTC DRUG Colgate Max Fresh Intense SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20111208 OTC MONOGRAPH FINAL part355 Mission Hills S.A. de C.V. SODIUM FLUORIDE 1.1 mg/g 65954-556_7d3a66c5-9498-41c7-982a-cf976539c319 65954-556 HUMAN OTC DRUG Colgate Junior Fresh Protect SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Mission Hills, S.A.de C.V. SODIUM FLUORIDE .24 mg/g 65954-559_affb597b-0812-4163-9e10-4f26783a40aa 65954-559 HUMAN OTC DRUG Colgate Cavity Protection SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20120225 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-560_59358456-751a-40ef-ad08-8a999653e803 65954-560 HUMAN OTC DRUG Colgate Optic White Cool Mild Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20130102 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g 65954-560_889e3730-c9d4-475a-8ff2-60e21fab33b0 65954-560 HUMAN OTC DRUG Colgate Optic White Cool Mild Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20120101 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g 65954-561_e47cdc8f-dd2c-4aaf-8951-27ec66e16321 65954-561 HUMAN OTC DRUG Colgate Optic White Enamel White SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20120625 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g 65954-563_a2b80a64-ee9f-4d42-bc0c-f824f5438864 65954-563 HUMAN OTC DRUG Colgate Optic White Dual Action Crystal Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20121220 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g 65954-564_11d0b755-0233-46b7-a668-d6a538ec2f24 65954-564 HUMAN OTC DRUG Colgate Max Fresh Cool Mint SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20080406 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-580_86eb79cc-2b46-4eae-9c91-9bd09767d51f 65954-580 HUMAN OTC DRUG Colgate Advanced Sensitive Plus Whitening SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20121223 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.1 mg/g; mg/g 65954-584_c1a0c979-23db-4774-b933-a92e145fd7a3 65954-584 HUMAN OTC DRUG Colgate Fresh N Protect Mild Mint SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20120106 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-587_12a3ce6b-3b92-4801-988d-29ac27f0ad2d 65954-587 HUMAN OTC DRUG Colgate Optic White Platinum Crystal Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20131118 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g 65954-588_bde04a53-8166-48f2-8b97-ff1cdf3f6f1f 65954-588 HUMAN OTC DRUG Colgate Optic White Platinum Cool Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20131118 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g 65954-591_8eb430a7-1a7e-4f3f-8341-a8f95d762ece 65954-591 HUMAN OTC DRUG Colgate Cavity Protection SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20140406 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-765_60ac73ae-3c75-4394-a03b-16714e7b61b2 65954-765 HUMAN OTC DRUG COLGATE Baking Soda and Peroxide Whitening Brisk Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110820 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM MONOFLUOROPHOSPHATE 1 mg/g 65954-768_e33bcd1c-d51b-4a06-81e1-052c38d090f2 65954-768 HUMAN OTC DRUG Colgate Baking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110820 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g 65954-769_14cba09e-0f3a-4468-8740-5600e579498d 65954-769 HUMAN OTC DRUG Colgate Optic White Icy Fresh Cool Fresh Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20131118 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g 65954-770_967df5ca-3fb2-4b2f-9aee-44fecb5d726a 65954-770 HUMAN OTC DRUG Colgate Sensitive Prevent and Repair SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20131218 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.1 mg/g; mg/g 65954-771_157fa11b-380a-4b45-b8b9-f68eb538de9f 65954-771 HUMAN OTC DRUG Colgate Optic White Sparkling Mint Flavor SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20131218 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g 65954-772_c5513d42-1b79-4e21-9898-a7db40eb72d3 65954-772 HUMAN OTC DRUG Colgate Optic White Enamel White Luminous Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20131218 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g 65954-773_c3e55aed-5e54-457c-86cc-65ec2fada675 65954-773 HUMAN OTC DRUG Colgate Sensitive Complete Protection SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20131218 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.1 mg/g; mg/g 65954-774_a301c256-8fed-4063-b7e0-378841faaaf3 65954-774 HUMAN OTC DRUG Colgate Optic White Platinum Express White Fresh Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20141031 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g 65954-775_530b8079-2fa6-469e-be9c-1be37effdfe4 65954-775 HUMAN OTC DRUG Colgate MaxFresh Anticavity Fluoride Electric Mint SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20141031 OTC MONOGRAPH FINAL part355 Mission Hills, S.A de C.V SODIUM FLUORIDE 1.1 mg/g 65954-776_3795d44d-ac49-47ba-80da-9c789bb99d46 65954-776 HUMAN OTC DRUG Colgate Sensitive Maximum Strength Mint Clean SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20140105 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.1 mg/g; mg/g 65954-900_36dbcd71-676d-41b4-b344-6e0f1ab3cba1 65954-900 HUMAN OTC DRUG Speed Stick 24/7 Fresh Rush ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20120401 OTC MONOGRAPH FINAL part350 Mission Hills S.A de C.V ALUMINUM CHLOROHYDRATE .1128 g/mL 65954-901_62db583f-ef64-4569-8d43-c06073412153 65954-901 HUMAN OTC DRUG Lady Speed Stick 24/7 Fresh Fusion ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20120401 OTC MONOGRAPH FINAL part350 Mission Hills S.A de C.V ALUMINUM CHLOROHYDRATE .1128 g/mL 65966-001_edabc2ce-e1c0-4db5-9d14-46294e20d231 65966-001 HUMAN OTC DRUG LA MER THE TREATMENT FLUID FOUNDATION SPF 15 TITANIUM DIOXIDE OCTINOXATE LIQUID TOPICAL 20000901 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC OCTINOXATE; TITANIUM DIOXIDE 2.2; 4.7 mL/100mL; mL/100mL 65966-009_56070748-6ce4-4c1b-826c-d704245d9528 65966-009 HUMAN OTC DRUG LA MER THE SPF 30 UV PROTECTING FLUID ZINC OXIDE, OCTINOXATE LIQUID TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC OCTINOXATE; ZINC OXIDE 7.5; 10 mL/100mL; mL/100mL 65966-010_a75e9378-d2a7-42e9-955a-558f5f84a1f7 65966-010 HUMAN OTC DRUG THE RADIANT CONCEALER SPF 15 TITANIUM DIOXIDE CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC TITANIUM DIOXIDE 4.65 g/100g 65966-011_708d9bb3-dcae-4afc-b8dd-51091774a325 65966-011 HUMAN OTC DRUG LA MER THE REPARATIVE FACE SUN Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE LOTION TOPICAL 20121111 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .0312; .052; .052; .02808; .0312 g/mL; g/mL; g/mL; g/mL; g/mL 65966-014_51797e8c-f078-4b37-a379-cac675095e17 65966-014 HUMAN OTC DRUG LA MER THE REPARATIVE BODY SUN Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE LOTION TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .0312; .052; .052; .02808; .0312 g/mL; g/mL; g/mL; g/mL; g/mL 65966-016_30c27a5d-5c99-464f-988e-6ee341a267a1 65966-016 HUMAN OTC DRUG LA MER THE BROAD SPECTRUM SPF 50 UV PROTECTING FLUID AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE LOTION TOPICAL 20130505 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .0312; .052; .052; .02808; .0312 g/mL; g/mL; g/mL; g/mL; g/mL 65966-111_0ef63975-eca4-41b6-a80c-0bafc0019d5a 65966-111 HUMAN OTC DRUG THE TREATMENT POWDER FOUNDATION SPF 15 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC OCTINOXATE; TITANIUM DIOXIDE 4.5; 4.9 g/100g; g/100g 65966-918_4eea5e21-1fc9-4259-aeb0-9642cb92477d 65966-918 HUMAN OTC DRUG THE SPF 18 FLUID TINT OCTINOXATE, HOMOSALATE, and AVOBENZONE LOTION TOPICAL 20050601 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC AVOBENZONE; HOMOSALATE; OCTINOXATE 3; 3.5; 7.5 mL/100mL; mL/100mL; mL/100mL 65974-162_ad24ba10-6133-49d5-8b14-0366cd58bf3e 65974-162 HUMAN PRESCRIPTION DRUG Sotradecol Sodium Tetradecyl Sulfate INJECTION, SOLUTION INTRAVENOUS 20041201 ANDA ANDA040541 Angiodynamics TETRADECYL HYDROGEN SULFATE (ESTER) 10 mg/mL 65974-163_ad24ba10-6133-49d5-8b14-0366cd58bf3e 65974-163 HUMAN PRESCRIPTION DRUG Sotradecol Sodium Tetradecyl Sulfate INJECTION, SOLUTION INTRAVENOUS 20041201 ANDA ANDA040541 Angiodynamics TETRADECYL HYDROGEN SULFATE (ESTER) 30 mg/mL 65976-100_e9ad8dff-1c43-4823-b244-2443ba595b34 65976-100 HUMAN PRESCRIPTION DRUG Arestin Minocycline Hydrochloride POWDER ORAL 20110321 NDA NDA050781 OraPharma, Inc. MINOCYCLINE HYDROCHLORIDE 1 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 65977-5025_61788ac8-2837-4419-942d-cb47143c95f2 65977-5025 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET ORAL 20100607 ANDA ANDA090061 Hetero Drugs Limited FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 65977-5033_98457ee9-35be-4d2f-84c2-b3283e553bbd 65977-5033 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20091106 ANDA ANDA090200 Hetero Drugs Limited Unit III METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 65977-5034_98457ee9-35be-4d2f-84c2-b3283e553bbd 65977-5034 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20091106 ANDA ANDA090200 Hetero Drugs Limited Unit III METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 65977-5036_b9acd365-1b80-4428-bd33-3a5eac814677 65977-5036 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101008 ANDA ANDA090515 Hetero Drugs Ltd., LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65977-5037_b9acd365-1b80-4428-bd33-3a5eac814677 65977-5037 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101008 ANDA ANDA090515 Hetero Drugs Ltd., LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65977-5038_b9acd365-1b80-4428-bd33-3a5eac814677 65977-5038 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101008 ANDA ANDA090515 Hetero Drugs Ltd., LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65977-5039_b9acd365-1b80-4428-bd33-3a5eac814677 65977-5039 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101008 ANDA ANDA090515 Hetero Drugs Ltd., LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 65977-5042_110aada7-dfe8-4ecf-80c7-4dac8907ad29 65977-5042 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20110412 ANDA ANDA091240 Hetero Drugs Ltd., INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65977-5043_110aada7-dfe8-4ecf-80c7-4dac8907ad29 65977-5043 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20110412 ANDA ANDA091240 Hetero Drugs Ltd., INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 65977-5044_5d414505-02dd-40a0-8777-cc798088b6dd 65977-5044 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20090925 ANDA ANDA090702 Hetero Drugs Limited LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] 65977-5045_5d414505-02dd-40a0-8777-cc798088b6dd 65977-5045 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20090925 ANDA ANDA090702 Hetero Drugs Limited LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 65977-5046_5d414505-02dd-40a0-8777-cc798088b6dd 65977-5046 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20090925 ANDA ANDA090702 Hetero Drugs Limited LITHIUM CARBONATE 600 mg/1 Mood Stabilizer [EPC] 66007-145_a7e74856-eb57-4153-bae9-008f0cfdbbf9 66007-145 HUMAN OTC DRUG Junior Strength Pain Relief Acetaminophen TABLET ORAL 20100726 OTC MONOGRAPH NOT FINAL part343 Capricorn Pharma Inc. ACETAMINOPHEN 160 mg/1 66007-204_bfb607f0-1c6a-470c-ad3b-933b3f5897f4 66007-204 HUMAN OTC DRUG Expectorant plus Cough Relief Guaifenesin and Dextromethorphan GRANULE ORAL 20100806 OTC MONOGRAPH FINAL part341 Capricorn Pharma Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/1; mg/1 66007-212_557a995c-3fe4-411c-94ef-f6d4f1bd0a55 66007-212 HUMAN OTC DRUG Childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20100929 OTC MONOGRAPH FINAL part341 Capricorn Pharma Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 66010-515_edcab71e-e03a-485e-8e50-839d883102c4 66010-515 HUMAN OTC DRUG American Continental Techlabs, LLC INSTANT HAND SANITIZER ethanol GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 American Continental Techlabs ETHANOL 600 mL/1000mL 66019-301_4079504a-ddfa-41c1-be06-893fe21b902d 66019-301 VACCINE FluMist Quadrivalent Influenza Vaccine Live Intranasal SPRAY NASAL 20140701 BLA BLA125020 MedImmune, LLC INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) LIVE (ATTENUATED) ANTIGEN; INFLUENZA A VIRUS A/TEXAS/50/2012 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 LIVE (ATTENUATED) ANTIGEN 10000000; 10000000; 10000000; 10000000 mg/.2mL; mg/.2mL; mg/.2mL; mg/.2mL Live Attenuated Influenza A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Influenza Vaccines [Chemical/Ingredient],Vaccines, Attenuated [Chemical/Ingredient] 66051-210_9d6dc4cb-ee23-4286-bddc-a8c59df112c4 66051-210 HUMAN OTC DRUG Haws Eyewash Additive purified water SOLUTION, CONCENTRATE CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL 20140703 OTC MONOGRAPH FINAL part349 Haws Corporation WATER 889.6 g/1000mL 66059-0001_d521df41-f102-4176-acc5-91dda4f437a5 66059-0001 HUMAN OTC DRUG RAMEDICA RAMEDICA OINTMENT TOPICAL 20001213 OTC MONOGRAPH NOT FINAL part348 Ramedicare Sdn. Bhd. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL; METHYL SALICYLATE 2.53; 2.3; 1.84; 2.3 g/g; g/g; g/g; g/g 66077-773_812707d0-433f-4f50-921c-48b64b5726f2 66077-773 HUMAN OTC DRUG Instant Foam ALCOHOL AEROSOL, FOAM TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part333 Ultra-Chem Inc. ALCOHOL 620 mg/g 66078-033_b558a27e-dcde-4ccd-a82c-d6c2a091a538 66078-033 HUMAN OTC DRUG Benzoyl Peroxide Benzoyl Peroxide GEL TOPICAL 20010923 OTC MONOGRAPH FINAL part333D MD Formulation BENZOYL PEROXIDE 10 g/100g 66078-035_6e906461-55a1-4620-9406-c0f50cf9d221 66078-035 HUMAN OTC DRUG Glycare Acne Glycolic Acid GEL TOPICAL 20011007 OTC MONOGRAPH FINAL part333D MD Formulation SALICYLIC ACID 1 g/100g 66078-110_c3fad29a-9dc1-4a2d-9bb1-3d745068b4d2 66078-110 HUMAN OTC DRUG Total Protrector 15 Octinoxate, Zinc Oxide CREAM TOPICAL 20070708 OTC MONOGRAPH NOT FINAL part352 MD Formulation OCTINOXATE; ZINC OXIDE 7.5; 4.9 g/100g; g/100g 66078-368_53a19b28-930b-45b1-ac78-aba6f64f8bd7 66078-368 HUMAN OTC DRUG Total Protector 30 Zinc Oxide,Octinaxade,Octisalate CREAM TOPICAL 20011213 OTC MONOGRAPH FINAL part352 MD Formulation OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 4; 7.8 g/100g; g/100g; g/100g 66078-440_73126032-358a-46f5-b86d-e69c5a355836 66078-440 HUMAN OTC DRUG Sun Total Protector 30 broad spectrum SPF 30 daily protection Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20120815 OTC MONOGRAPH NOT FINAL part352 MD Formulation. OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 4; 7.8 g/100g; g/100g; g/100g 66078-503_a6cc9a25-ad18-4d07-8efa-8ef185552e6f 66078-503 HUMAN OTC DRUG Sun Total Protector Color 30 Light Tint Zinc Oxide, Octisalate, Octinoxate CREAM TOPICAL 20070520 OTC MONOGRAPH NOT FINAL part352 MD Formulations OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 4; 7.8 mL/100mL; mL/100mL; mL/100mL 66078-504_22437a1e-58af-4812-a9c1-17c492077efd 66078-504 HUMAN OTC DRUG Total Protector Color 30 Medium Tint Octinoxate CREAM TOPICAL 20050128 OTC MONOGRAPH NOT FINAL part352 MD Formulation OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 4; 7.8 g/100g; g/100g; g/100g 66078-505_e95e2ede-4887-4900-ae8d-a1b8a1b9ec62 66078-505 HUMAN OTC DRUG Sun Total Protector Color 30 Dark Tint Sun Total Protector Color 30 Dark Tint CREAM TOPICAL 20070520 OTC MONOGRAPH NOT FINAL part352 MD Formulations OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 4; 7.8 mL/100mL; mL/100mL; mL/100mL 66083-741_fbfd6217-d2ac-4f10-b44d-1b35cea90f0b 66083-741 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Boone Drugs, Inc OXYGEN 99 L/100L 66096-113_872d9465-deca-4bc7-888b-26b8860277b2 66096-113 HUMAN OTC DRUG ANXIETY/STRESS RELIEF Argentum Nitricum, Aurum Metallicum, Avena Sativa, Gelsemium Sempervirens, Hyoscyamus Niger, Ignatia Amara, Moschus, Natrum Muriaticum, Passiflora Incarnata, Valeriana Officinalis. SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. AVENA SATIVA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLD; HYOSCYAMUS NIGER; MOSCHUS MOSCHIFERUS WHOLE; PASSIFLORA INCARNATA TOP; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; TIN; VALERIAN 2; 13; 13; 13; 13; 2; 8; 13; 13; 13; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 66096-125_8ed078ba-478d-4352-a33f-645bc10cd424 66096-125 HUMAN OTC DRUG Weight Control Aceticum Ac, Anacard Or, Baryta Iod, Calc Carb, Capsicum, Fucus, Graphites,, Nat Sulphuricum, Phytolacca, Stannum Met, Thyroidinum, Zinc Met. SPRAY ORAL 20130930 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ACETIC ACID; BARIUM IODIDE; CAPSICUM; FUCUS VESICULOSUS; GRAPHITE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; SEMECARPUS ANACARDIUM JUICE; SODIUM SULFATE; THYROID, UNSPECIFIED; TIN; ZINC 10; 12; 14; 5; 14; 14; 7; 14; 14; 12; 16; 14 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 66096-175_80c1ab00-ff7f-447a-80e8-78e044f07704 66096-175 HUMAN OTC DRUG OHM Endocrine Feminine Terrain Cyclamen Europaeum, Erigeron Canadensis, Ignatia Amara, Lachesis Mutus, Moschus, Oophorinum, Pulsatilla, Sepia, Thlaspi Bursa-Pastoris, Viburnum Opulus. LIQUID ORAL 20120312 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. CAPSELLA BURSA-PASTORIS; CONYZA CANADENSIS; CYCLAMEN PURPURASCENS TUBER; LACHESIS MUTA VENOM; MOSCHUS MOSCHIFERUS WHOLE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; SUS SCROFA OVARY; VIBURNUM OPULUS BARK 6; 6; 7; 12; 12; 12; 12; 12; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 66096-678_4d0c940b-588f-43ee-963c-e85814d2af72 66096-678 HUMAN OTC DRUG Rejuvenate 2000 Maximum Strength Formula For Men rSomatotropin, rIGF-I, rIGF-II, RNA, DNA,Glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met. SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; COBALT; DALOTUZUMAB; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; HERRING SPERM DNA; IRON; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK LIVER; POTASSIUM PHOSPHATE, DIBASIC; SACCHAROMYCES CEREVISIAE RNA; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SOMATROPIN; STRYCHNOS IGNATII SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; TRIBASIC CALCIUM PHOSPHATE; ZINC 10; 10; 10; 10; 10; 12; 6; 10; 10; 10; 6; 10; 12; 10; 12; 12; 10; 10; 6; 12; 6; 12; 10; 10; 6; 10; 6; 6; 6; 6; 6; 6; 10; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 66096-682_e0053003-1528-42c0-83f4-80af96ea809a 66096-682 HUMAN OTC DRUG Rejuvenate 2000 Maximum Strength Formula For Women rSomatotropin, rIGF-I, rIGF-II, RNA, DNA,Glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met. SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; COBALT; DALOTUZUMAB; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; HERRING SPERM DNA; IRON; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK LIVER; POTASSIUM PHOSPHATE, DIBASIC; SACCHAROMYCES CEREVISIAE RNA; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SOMATROPIN; STRYCHNOS IGNATII SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; SUS SCROFA PLACENTA; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; TRIBASIC CALCIUM PHOSPHATE; ZINC 10; 10; 10; 10; 10; 12; 6; 10; 10; 10; 6; 10; 12; 10; 12; 12; 10; 10; 6; 12; 6; 12; 10; 10; 6; 10; 6; 6; 6; 6; 6; 6; 10; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 66096-683_d4dbd302-7b8d-4d5f-a0c1-82cfccd25bf2 66096-683 HUMAN OTC DRUG Rejuvenate 2000 Power Up Formula For Men rSomatotropin, rIGF-I, rIGF-II, RNA, DNA,Glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met. SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; COBALT; DALOTUZUMAB; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; HERRING SPERM DNA; IRON; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK LIVER; POTASSIUM PHOSPHATE, DIBASIC; SACCHAROMYCES CEREVISIAE RNA; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SOMATROPIN; STRYCHNOS IGNATII SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; TRIBASIC CALCIUM PHOSPHATE; ZINC 10; 10; 10; 10; 10; 12; 6; 10; 10; 10; 6; 10; 12; 10; 12; 12; 10; 10; 6; 12; 6; 12; 10; 10; 6; 10; 6; 6; 6; 6; 6; 6; 10; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 66096-684_96a1a4f5-c98e-48b5-a8b8-a5d3d66ba9cd 66096-684 HUMAN OTC DRUG Rejuvenate 2000 PM Formula For Men rSomatotropin, rIGF-I, rIGF-II, RNA, DNA,Glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met. SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; COBALT; DALOTUZUMAB; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; HERRING SPERM DNA; IRON; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK LIVER; POTASSIUM PHOSPHATE, DIBASIC; SACCHAROMYCES CEREVISIAE RNA; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SOMATROPIN; STRYCHNOS IGNATII SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; TRIBASIC CALCIUM PHOSPHATE; ZINC 10; 10; 10; 10; 10; 12; 6; 10; 10; 10; 6; 10; 12; 10; 12; 12; 10; 10; 6; 12; 6; 12; 10; 10; 6; 10; 6; 6; 6; 6; 6; 6; 10; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 66096-685_77dce39e-524d-422b-b355-e64d9fcdf176 66096-685 HUMAN OTC DRUG Rejuvenate 2000 PM Formula For Women rSomatotropin, rIGF-I, rIGF-II, RNA, DNA,Glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met. SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; COBALT; DALOTUZUMAB; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; HERRING SPERM DNA; IRON; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK LIVER; POTASSIUM PHOSPHATE, DIBASIC; SACCHAROMYCES CEREVISIAE RNA; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SOMATROPIN; STRYCHNOS IGNATII SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; SUS SCROFA PLACENTA; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; TRIBASIC CALCIUM PHOSPHATE; ZINC 10; 10; 10; 10; 10; 12; 6; 10; 10; 10; 6; 10; 12; 10; 12; 12; 10; 10; 6; 12; 6; 12; 10; 10; 6; 10; 6; 6; 6; 6; 6; 6; 10; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 66096-686_83a794d4-9d73-4769-83e1-50efdb889012 66096-686 HUMAN OTC DRUG Rejuvenate 2000 Athletic Formula For Women rSomatotropin, rIGF-I, rIGF-II, RNA, DNA,Glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met. SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; COBALT; DALOTUZUMAB; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; HERRING SPERM DNA; IRON; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK LIVER; POTASSIUM PHOSPHATE, DIBASIC; SACCHAROMYCES CEREVISIAE RNA; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SOMATROPIN; STRYCHNOS IGNATII SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; SUS SCROFA PLACENTA; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; TRIBASIC CALCIUM PHOSPHATE; ZINC 10; 10; 10; 10; 10; 12; 6; 10; 10; 10; 6; 10; 12; 10; 12; 12; 10; 10; 6; 12; 6; 12; 10; 10; 6; 10; 6; 6; 6; 6; 6; 6; 10; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 66096-687_c7f29d1b-48fb-496b-b730-c7bc15d3746a 66096-687 HUMAN OTC DRUG Rejuvenate 2000 Athletic Formula For Men rSomatotropin, rIGF-I, rIGF-II, RNA, DNA,Glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met. SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; COBALT; DALOTUZUMAB; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; HERRING SPERM DNA; IRON; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK LIVER; POTASSIUM PHOSPHATE, DIBASIC; SACCHAROMYCES CEREVISIAE RNA; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SOMATROPIN; STRYCHNOS IGNATII SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; TRIBASIC CALCIUM PHOSPHATE; ZINC 10; 10; 10; 10; 10; 12; 6; 10; 10; 10; 6; 10; 12; 10; 12; 12; 10; 10; 6; 12; 6; 12; 10; 10; 6; 10; 6; 6; 6; 6; 6; 6; 10; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 66096-688_fec678e9-4432-4342-86c4-0fad4925303c 66096-688 HUMAN OTC DRUG KENZAPUR Glonoinum, Lachesis mutus, Natrum muriaticum, Natrum sulphuricum, Thuja occidentalis LIQUID ORAL 20130701 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. LACHESIS MUTA VENOM; NITROGLYCERIN; SODIUM CHLORIDE; SODIUM SULFATE; THUJA OCCIDENTALIS LEAFY TWIG 12; 6; 6; 6; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 66097-001_566b85fe-7294-48d0-a4da-910cb72a2e82 66097-001 HUMAN OTC DRUG SISLEYA Global Anti-Age Hand care SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20130120 OTC MONOGRAPH NOT FINAL part352 C.F.E.B. Sisley AVOBENZONE; OCTINOXATE; OCTISALATE 20; 50; 30 mg/g; mg/g; mg/g 66097-002_24f1ed75-2006-4b85-a9e3-b3e435d3f2ff 66097-002 HUMAN OTC DRUG SUNLEYA Age minimizing sun care SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20130121 OTC MONOGRAPH NOT FINAL part352 C.F.E.B. Sisley AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 50; 50; 40 mg/g; mg/g; mg/g; mg/g 66097-003_44d08d5d-2f13-4aec-b051-12c145f00339 66097-003 HUMAN OTC DRUG SUNLEYA Age minimizing sun care SPF 50 plus AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20130121 OTC MONOGRAPH NOT FINAL part352 C.F.E.B. Sisley AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 150; 50; 100 mg/g; mg/g; mg/g; mg/g 66097-004_15e8fdee-9aad-4a8f-bced-953db3e4bae9 66097-004 HUMAN OTC DRUG SUPER CREME SOLAIRE CORPS Body sun care SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20130121 OTC MONOGRAPH NOT FINAL part352 C.F.E.B. Sisley AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 50; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL 66097-005_f68ec431-417a-4a5a-b703-2eab8a7c4c72 66097-005 HUMAN OTC DRUG SUPER STICK SOLAIRE sun-sensitive areas colorless SPF 30 TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part352 C.F.E.B. Sisley TITANIUM DIOXIDE; ZINC OXIDE 95; 187.5 mg/g; mg/g 66097-006_c00757cf-4966-4809-9cdb-3d9312c4129a 66097-006 HUMAN OTC DRUG SUPER STICK SOLAIRE sun-sensitive areas tinted SPF 30 TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part352 C.F.E.B. Sisley TITANIUM DIOXIDE; ZINC OXIDE 95; 187.5 mg/g; mg/g 66116-223_42a9d92c-f6d9-42b8-a58c-fd51cca49258 66116-223 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 MedVantx, Inc. AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 66116-234_ce37a533-6f4c-4263-a8c6-d61b76d56adb 66116-234 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19730112 ANDA ANDA083177 MedVantx, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 66116-255_937ecebf-af54-431b-a326-3b4662853b49 66116-255 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 19900930 ANDA ANDA062702 MedVantx, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 66116-300_0e7e3947-be0e-4407-a424-a365f99f4350 66116-300 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA075776 MedVantx, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 66116-310_cd217f3c-5a6e-4def-a125-e70ad4874e9b 66116-310 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075752 MedVantx, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 66116-316_bb0802ae-207d-40c7-8e80-4dcc8ebe94e2 66116-316 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 MedVantx, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66116-329_690f0271-5966-4015-8bb2-56f941f14c50 66116-329 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20070222 ANDA ANDA077048 MedVantx, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66116-344_ff5aa574-0ef8-482f-815f-32357a959707 66116-344 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 MedVantx, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 66116-346_dad83d68-f35a-42ca-a65c-f95677e1c9ca 66116-346 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20060425 ANDA ANDA076056 MedVantx, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66116-352_ab1bacf9-00fa-4332-8cb8-a5071b2a7723 66116-352 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077038 MedVantx, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66116-353_9171c747-d032-4732-b067-17cd9c77357a 66116-353 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077038 MedVantx, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66116-357_9426f88d-2f3f-4dc9-ba17-f4bc0be91963 66116-357 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 19930324 ANDA ANDA073137 MedVantx, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 66116-358_6b3ca748-7172-4c53-b5ae-7e17dad918eb 66116-358 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 MedVantx, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 66116-359_2c04fc9b-5f83-4a3a-87e3-2b07affd0ad0 66116-359 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070974 MedVantx, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 66116-360_a53e29b3-7436-419f-ad6c-0a805d97ab1a 66116-360 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20110718 ANDA ANDA074388 MedVantx, Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 66116-361_b4647b22-9a70-4259-a8f6-fac0ce1ac5c5 66116-361 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20110913 ANDA ANDA076373 MedVantx, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 66116-366_c6c3b8b0-4932-4cee-af0b-f14425925c50 66116-366 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 MedVantx, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66116-367_c6c3b8b0-4932-4cee-af0b-f14425925c50 66116-367 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 MedVantx, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66116-368_c6c3b8b0-4932-4cee-af0b-f14425925c50 66116-368 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 MedVantx, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66116-369_f8f30cc7-94e3-49f4-84c5-1f43ccdabc35 66116-369 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 MedVantx, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 66116-370_5fb922d2-e71b-4f67-847e-92d820ebc3d6 66116-370 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20100727 ANDA ANDA075978 MedVantx, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 66116-371_1743d408-6eac-41ae-8f80-0053f9d24e85 66116-371 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 MedVantx, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66116-372_8d53dc31-a51f-4326-a6cd-5aa6aebda3ed 66116-372 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 MedVantx, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 66116-375_918887d8-5c36-49e9-832d-d03a1d15f2a8 66116-375 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 MedVantx, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 66116-376_478b6915-9d73-4681-bee0-0f4540fd4839 66116-376 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 MedVantx, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66116-377_c3162f51-f3d1-4269-8d56-e56dc9da43fd 66116-377 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 MedVantx, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66116-378_5fb922d2-e71b-4f67-847e-92d820ebc3d6 66116-378 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20100727 ANDA ANDA075978 MedVantx, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 66116-388_9479a921-2778-47be-9833-23106e4e64c3 66116-388 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20080118 ANDA ANDA065248 MedVantx, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 66116-389_f9bd1793-4e13-47e0-98cd-30ee06390a64 66116-389 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 MedVantx, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 66116-390_197c51b6-d0b8-4cd6-89f6-be666168092c 66116-390 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077038 MedVantx, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66116-391_26ce821b-bb78-4afd-96ee-528b1dbf88c4 66116-391 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075752 MedVantx, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 66116-392_3ba4c6e0-cb83-43b5-a623-1f2af9c2b07c 66116-392 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20061002 ANDA ANDA078008 MedVantx, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66116-393_f6bf82d1-b768-49de-bc6c-1078dfc3c359 66116-393 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20061002 ANDA ANDA078008 MedVantx, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66116-398_9ef147ae-fcc5-4fd1-b65c-7a37dae89b91 66116-398 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060201 ANDA ANDA065215 MedVantx, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 66116-400_eac25cfc-92cb-411c-b109-25731815b936 66116-400 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 MedVantx, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 66116-401_b8585313-58f6-42af-bab7-e524ccdacd08 66116-401 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20091110 ANDA ANDA078254 MedVantx, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 66116-402_6b1141e6-f233-4440-87c2-cd349d76d1ec 66116-402 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110120 ANDA ANDA071523 MedVantx, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 66116-403_e65e3c28-a40b-4daa-8fd5-29f112575b68 66116-403 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 MedVantx, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66116-404_0060d1b1-4cfc-4b69-86a8-9bd44a071e94 66116-404 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 MedVantx, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66116-405_789d1ece-181b-4eca-b449-f15b6071de90 66116-405 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 MedVantx, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66116-406_cc8258c3-6265-4b26-a1bf-df6476cc962a 66116-406 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 MedVantx, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66116-407_38d9d7d7-9f81-4517-acee-e34232215800 66116-407 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 MedVantx, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 66116-408_84e3af60-8814-49f6-918e-a4e1c702aa05 66116-408 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 MedVantx, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66116-409_b6052b11-a7c1-4f55-8ef5-239541c466ff 66116-409 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 MedVantx, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66116-412_c525925d-e16d-434c-a25d-4c5ff1b5ef24 66116-412 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 MedVantx, Inc. DOXYCYCLINE HYCLATE 100 mg/1 66116-413_2fbc01fb-b787-4ff1-bb9f-280dfe975531 66116-413 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET, FILM COATED ORAL 20100922 ANDA ANDA076840 MedVantx, Inc. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 66116-414_7b7f90ab-8336-48a2-9762-c23a02f9172e 66116-414 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970423 ANDA ANDA074556 MedVantx, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 66116-415_69605072-f130-4054-95b0-ff3c34554fb9 66116-415 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090382 MedVantx, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 66116-417_010ea8e3-4955-4332-8cca-f45977ab56c6 66116-417 HUMAN OTC DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20091019 ANDA ANDA078862 MedVantx, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 66116-418_1e505c90-79e4-4267-83c4-2fbb93d75cc6 66116-418 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20111024 ANDA ANDA065153 MedVantx, Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 66116-419_40eb0186-e55e-4f93-9233-996297910dbd 66116-419 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20120316 ANDA ANDA018413 MedVantx, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 66116-427_6a957e2e-f1ea-416b-81de-f273234e6db9 66116-427 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20120318 ANDA ANDA074497 MedVantx, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 66116-428_a9942f9c-5929-4b9b-aa27-64f7f9b164e3 66116-428 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 MedVantx, Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 66116-429_40a98410-9568-4278-959e-ca3517a9b119 66116-429 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070906 ANDA ANDA076373 MedVantx, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 66116-432_3f626e54-b043-4556-9568-ace556cff9e9 66116-432 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120419 ANDA ANDA076802 MedVantx, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 66116-433_a098f1d0-577e-474e-baab-d200c896a294 66116-433 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100611 ANDA ANDA076269 MedVantx, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 66116-434_b1894876-1824-4f87-95ed-d2a805683e15 66116-434 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20051003 ANDA ANDA076618 MedVantx, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66116-435_cf8f5d60-a2f8-4fa4-ba39-6d175cf3abce 66116-435 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100427 ANDA ANDA077630 MedVantx, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 66116-436_cbcb4427-7a99-467c-915f-a8b4c90e2832 66116-436 HUMAN PRESCRIPTION DRUG Tri-Sprintec norgestimate and ethinyl estradiol KIT 20110125 ANDA ANDA075808 MedVantx, Inc. 66116-437_c6bf064f-e5d9-42e3-b2e5-86ae3836d357 66116-437 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950222 ANDA ANDA074056 MedVantx, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 66116-439_aafd2b0f-435a-4805-9b17-c02f99df59d5 66116-439 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20101014 ANDA ANDA077936 MedVantx, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66116-443_d224143d-2199-4969-a64f-dc2e6b865ec4 66116-443 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060720 ANDA ANDA077936 MedVantx, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66116-444_6fa84b06-4292-43c2-888e-3e62b4c19a3d 66116-444 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110913 ANDA ANDA075435 MedVantx Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 66116-445_16bda7b5-a5a5-4478-9df3-beb396bd677f 66116-445 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20120424 ANDA ANDA077048 MedVantx, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66116-446_213502a2-f667-4da6-a4b9-462eb303c401 66116-446 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100323 ANDA ANDA076846 MedVantx, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 66116-447_0cca3e8d-bf4d-4119-90b4-91144c73e226 66116-447 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 MedVantx, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66116-450_7306dad3-30ed-47ed-9fb9-d5d9e1ec5247 66116-450 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101220 ANDA ANDA077157 MedVantx, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 66116-452_f88c39fa-ed74-42f4-a886-c268daf8f3a6 66116-452 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101228 ANDA ANDA076958 MedVantx, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 66116-453_7125a96a-0e98-4984-8b57-a2e7a99b7b0d 66116-453 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20120320 ANDA ANDA076001 MedVantx, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66116-455_5665e444-b914-460d-a023-8a241c18cbb6 66116-455 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20071108 ANDA ANDA077048 MedVantx, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66116-464_f1a9e2fc-f75a-46a6-82f1-c11fa0b281a2 66116-464 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 MedVantx, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66116-467_c0e3e84e-2c4e-45d9-b2e2-7c4d208eca67 66116-467 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 MedVantx, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66116-470_b61cdce5-9fb5-4901-a768-4282a684db3f 66116-470 HUMAN PRESCRIPTION DRUG Gianvi Drospirenone and ethinyl estradiol KIT 20101022 NDA NDA021676 MedVantx, Inc. 66116-471_26b0400e-edce-44f2-84de-67f178488683 66116-471 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide SPRAY, METERED NASAL 20110406 ANDA ANDA078104 MedVantx, Inc. TRIAMCINOLONE ACETONIDE 55 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 66116-473_04d66f28-86eb-4c3e-b31f-26e5324cf48b 66116-473 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20110407 ANDA ANDA090510 MedVantx, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 66116-477_bc4ce768-a615-4458-9d60-baeada6886cd 66116-477 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 MedVantx, Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 66116-478_ee4c9c41-8ac4-4647-a765-731d8376c2d2 66116-478 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20111116 ANDA ANDA065096 MedVantx, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 66116-479_16a686e6-63f4-478f-a673-02dde9474eda 66116-479 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20090618 ANDA ANDA065359 MedVantx, Inc. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 66116-480_c4022360-6081-451e-806e-4632a05c6e57 66116-480 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 MedVantx, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 66116-481_892aa268-0790-4e2c-8faa-d8cbeb200abd 66116-481 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20111221 ANDA ANDA076077 MedVantx, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 66116-482_d7aa2791-95d9-4732-afe4-89d70f01d152 66116-482 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 MedVantx, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 66116-484_a63d3ace-768f-4e1b-a5e9-dad1817453b9 66116-484 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER MedVantx, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 66116-485_1acbda65-ead7-4947-841c-8788c3ee4c00 66116-485 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 MedVantx, Inc. PREDNISONE 5 mg/1 66116-487_f754cce8-1871-4bd6-9082-86607da9c8ae 66116-487 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 MedVantx, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 66116-494_89033966-72f2-44b3-8335-3d12e82f27fe 66116-494 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA076999 MedVantx, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 66116-498_a0bd00e9-9813-4ea7-b640-1eb59202751b 66116-498 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 MedVantx, Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66116-503_b24549cf-6c14-4e49-8756-5bd6d88ec6b8 66116-503 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA078605 MedVantx, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 66116-504_a3ae5cba-f495-4593-b8fc-5ada34790745 66116-504 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 MedVantx, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 66116-507_d50f36f5-5f08-444b-8c9f-11774629273f 66116-507 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 MedVantx, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 66116-508_6fecbc15-915c-4434-b9e3-cfc1aa33a1ba 66116-508 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET ORAL 20040609 ANDA ANDA076089 MedVantx, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 66116-509_60bf8e22-284b-4dc0-9c03-694813cc89ac 66116-509 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065153 MedVantx, Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 66116-510_8267f4f7-a557-400e-a1d8-07825c39f9ef 66116-510 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 MedVantx, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 66116-512_4b4d9e67-2cca-4c64-80f2-b4f03950b6b3 66116-512 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19900930 ANDA ANDA072488 MedVantx, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 66116-513_edde25d4-9ac3-4b11-8b65-be221e06f37e 66116-513 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20080125 ANDA ANDA081297 MedVantx, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 66116-516_5a0e55c9-950b-4d23-b125-e6ffd42b518f 66116-516 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA077655 MedVantx, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 66116-518_b499b520-e7d8-4a21-8ff1-222925577d38 66116-518 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 19970912 ANDA ANDA075165 MedVantx, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 66116-521_47072dcb-fe13-4aa3-849b-b7b3fbb94c51 66116-521 HUMAN PRESCRIPTION DRUG clonidine hydrochloride Clonidine Hydrochloride TABLET ORAL 20111213 ANDA ANDA091368 MedVantx, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 66116-524_4e9ac94f-4d85-4731-8b7f-6188209b4a9c 66116-524 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin Monohydrate POWDER, FOR SUSPENSION ORAL 20080922 ANDA ANDA065419 MedVantx, Inc. AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 66116-527_6a682677-4a99-43a5-a991-af7f2d69aca1 66116-527 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19950929 ANDA ANDA074421 MedVantx, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 66116-529_877417ef-7706-44cf-a8a7-1fec3e7a0266 66116-529 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20071214 ANDA ANDA070756 MedVantx, Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66116-601_e186510b-9fa5-4325-b4ed-90aa0c5e181f 66116-601 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070033 MedVantx, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 66116-603_da5df185-b694-4855-b31f-24fed4b806d7 66116-603 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 19981211 ANDA ANDA089081 MedVantx, Inc. PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 66116-604_ff3765cb-352c-48ad-a1a0-04a1777f1713 66116-604 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 MedVantx, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 66116-605_adb0c2bc-adc3-4f53-a3df-65c48c02d2e4 66116-605 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20060718 ANDA ANDA040622 MedVantx, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 66116-607_ca2ed054-b1a5-4174-b107-a26d8c9b31b2 66116-607 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 MedVantx, Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 66116-810_96e73d2d-4fd5-4ab0-99d9-6d396231645f 66116-810 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 19950406 ANDA ANDA074141 MedVantx, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 66116-821_3bf1718a-fedc-4834-831e-b3b044f80ee6 66116-821 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19900930 ANDA ANDA061926 MedVantx, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 66116-841_c41f391a-f83c-4779-b5cb-4019c959b6ce 66116-841 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075752 MedVantx, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 66125-001_c973aeee-c119-4426-ab51-f174cdd4acea 66125-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Keene Medical Products, Inc. OXYGEN 99 L/100L 66129-010_8cd1bbaf-1a66-4501-bac4-6ffc3242db3e 66129-010 HUMAN OTC DRUG Topiclear Skin Lightening Hydroquinone CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 1; .25 g/50g; g/50g 66129-011_3f238fee-d6a7-461c-83ce-0d0310ef9fbd 66129-011 HUMAN OTC DRUG Topiclear Lemon HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 1; .25 g/50g; g/50g 66129-012_a00a4385-86e1-4beb-a83f-8f6bc2c9776f 66129-012 HUMAN OTC DRUG Topiclear Cocoa Butter HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 1; .25 g/50g; g/50g 66129-015_ece9fad2-01b6-4316-a743-9c85930ace28 66129-015 HUMAN OTC DRUG Topiclear Carrot HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 1; .25 g/50g; g/50g 66129-020_845405e7-dab2-425f-9a87-7e9ec1debb42 66129-020 HUMAN OTC DRUG Topiclear Hydroquinone LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 10; 2.5 mL/500mL; mL/500mL 66129-028_207152a7-4ca6-4dbe-b2c4-c1cafb1f6ab4 66129-028 HUMAN OTC DRUG Topiclear Xtra beauty HYDROQUINONE LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 10; 2.5 mL/500mL; mL/500mL 66129-031_57f4cf56-d0e0-498c-8835-eacdf01eff36 66129-031 HUMAN OTC DRUG Topiclear Xtra lemon beauty HYDROQUINONE LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 10; 2.5 mL/500mL; mL/500mL 66129-032_06de2dba-989d-49dc-bc24-53ef09729984 66129-032 HUMAN OTC DRUG Topiclear Cocoa Butter beauty HYDROQUINONE LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 10; 2.5 mL/500mL; mL/500mL 66129-035_e84c9401-4f99-4e39-be46-ea8dd05404c6 66129-035 HUMAN OTC DRUG Topiclear Xtra beauty HYDROQUINONE LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 10; 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OXYGEN 99 L/100L 66141-640_6298478d-16d8-4901-8770-e4224cb802c9 66141-640 HUMAN OTC DRUG Thursday Plantation Tea Tree Antiseptic OIL TOPICAL 20100301 UNAPPROVED DRUG OTHER Integria Healthcare Ballina TEA TREE OIL 25 mL/25mL 66141-641_f8b79c4b-e6fa-44f9-89d9-67bddda77289 66141-641 HUMAN OTC DRUG Thursday Plantation Tea Tree Antiseptic OIL TOPICAL 20100301 UNAPPROVED DRUG OTHER Integria Healthcare Ballina AUSTRALIAN TEA TREE OIL 50 mL/50mL 66141-643_568dd84f-a59f-4ce3-aaf6-6180045b8490 66141-643 HUMAN OTC DRUG Thursday Plantation Tea Tree Antiseptic Cream CREAM TOPICAL 20100301 UNAPPROVED DRUG OTHER Integria Healthcare Ballina AUSTRALIAN TEA TREE OIL 5 g/100g 66141-644_bbe03f6e-37db-49c2-8930-77727aba77bf 66141-644 HUMAN OTC DRUG Thursday Plantation Tea Tree Antiseptic OINTMENT TOPICAL 20100301 UNAPPROVED DRUG OTHER Integria Healthcare Ballina TEA TREE OIL 3 g/50g 66171-123_df7244d8-331d-4e41-8b9e-edf2be7c0d50 66171-123 HUMAN OTC DRUG Dr.Denese SPF 30 Defense Day ZINC OXIDE, OCTINOXATE CREAM TOPICAL 20110521 OTC MONOGRAPH FINAL part352 SkinScience Labs, Inc OCTINOXATE; 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TITANIUM DIOXIDE .6; 7.5 mL/30mL; mL/30mL 66184-401_e837b008-0ff4-4a8d-943c-a61ce2082124 66184-401 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen 050 Ivory Titanium Dioxide and Octinoxate LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .606; .302 g/30mL; g/30mL 66184-402_d105bde0-f783-4ccf-8c2e-591ca8749444 66184-402 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen 350 Warm Sand Titanium Dioxide and Octinoxate LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .606; .302 g/30mL; g/30mL 66184-405_240a0a22-eb1c-4884-a4f0-a6e94b69696b 66184-405 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen Titanium Dioxide LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .6; 7.5 mL/30mL; mL/30mL 66184-410_1e00556d-f222-47c4-af45-8a225be20d0a 66184-410 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen Titanium Dioxide LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .6; 7.5 mL/30mL; mL/30mL 66184-415_67903236-dad1-421d-972c-4bca1ce941d5 66184-415 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen Titanium Dioxide LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .6; 7.5 mL/30mL; mL/30mL 66184-420_891a328d-d81e-4244-afa0-3e633fd0c0b8 66184-420 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen Titanium Dioxide LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .6; 7.5 mL/30mL; mL/30mL 66184-425_714c3a9a-8472-4d8d-be16-7af988e851e1 66184-425 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen Titanium Dioxide LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .6; 7.5 mL/30mL; mL/30mL 66184-430_ff1f61bf-fb95-4296-a969-bb996dfb7321 66184-430 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen Titanium Dioxide LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .6; 7.5 mL/30mL; mL/30mL 66184-435_c219cb36-5d14-4e78-84b0-eeb261a86eda 66184-435 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen Titanium Dioxide LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .6; 7.5 mL/30mL; mL/30mL 66184-436_a73079b6-4688-41b6-9290-cbb2b9a7180b 66184-436 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen 850 Toffee Titanium Dioxide and Octinoxate LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .606; .302 g/30mL; g/30mL 66184-437_48ac482f-e7a1-45ea-80ad-1cc4f3e11bb0 66184-437 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen 900 Walnut Titanium Dioxide and Octinoxate LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .606; .302 g/30mL; g/30mL 66184-438_052f6f12-d319-4084-bf1d-3bfe5cb05f78 66184-438 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen 950 Espresso Titanium Dioxide and Octinoxate LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .606; .302 g/30mL; g/30mL 66184-440_4e3a1517-3a7f-40d0-a758-8ad02839eb5a 66184-440 HUMAN OTC DRUG ckone waterfresh face make up SPF 15 100 porcelain Titanium Dioxide CREAM TOPICAL 20120119 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE 2.4; 4.95 mL/9.9g; mL/9.9g 66184-445_710ff1f2-4f10-4f4e-9497-39f3aaafe9e3 66184-445 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 200 fair Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE 2.4; 4.95 mL/9.9g; mL/9.9g 66184-450_da022522-4d07-46e0-869d-d5549788ae6c 66184-450 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 300 sand Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE 2.4; 4.95 mL/9.9g; mL/9.9g 66184-455_ebc87358-cbe9-466f-be2d-0443203e7349 66184-455 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 350 beige Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE 2.4; 4.95 mL/9.9g; mL/9.9g 66184-460_b061a903-746b-4b5d-8077-010292c4ef43 66184-460 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 400 bisque Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE 2.4; 4.95 mL/9.9g; mL/9.9g 66184-465_af503a65-f996-485c-94f8-1d72ad56ec7e 66184-465 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 450 golden Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE 2.4; 4.95 mL/9.9g; mL/9.9g 66184-470_746cec21-9366-41e3-9799-3a712d1c3cc5 66184-470 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 500 tan Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE 2.4; 4.95 mL/9.9g; mL/9.9g 66184-475_2d916e0f-0dd1-416f-8f92-9d5186c2eca9 66184-475 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 600 honey Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE 2.4; 4.95 mL/9.9g; mL/9.9g 66184-480_eff07827-591e-423b-9a28-22fb6e0d0fc5 66184-480 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 700 caramel Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE 2.4; 4.95 mL/9.9g; mL/9.9g 66184-485_dd6b5d41-08a7-4cc1-bb2f-a786568256f4 66184-485 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 800 cappucino Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE 2.4; 4.95 mL/9.9g; mL/9.9g 66184-490_d6103ba2-6d63-4492-900e-50810f6d0b94 66184-490 HUMAN OTC DRUG ck one airlight pressed powder spf 15 porcelain 100 Titanium Dioxide POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; ZINC OXIDE 1.475; 100 mg/10g; mg/10g 66184-495_8647421e-830c-4573-bbe3-3813fc3f2474 66184-495 HUMAN OTC DRUG ck one airlight pressed powder spf 15 fair 200 Titanium Dioxide POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; ZINC OXIDE 1.475; 100 mg/10g; mg/10g 66184-500_33dd86e2-8c6c-407b-a4fa-d086bde8a648 66184-500 HUMAN OTC DRUG ck one airlight pressed powder spf 15 sand 300 Titanium Dioxide POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; ZINC OXIDE 1.475; 100 mg/10g; mg/10g 66184-505_9d2457ac-3cf8-4942-8565-b1df6127ea94 66184-505 HUMAN OTC DRUG ck one airlight pressed powder spf 15 bisque 400 Titanium Dioxide POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; ZINC OXIDE 1.475; 100 mg/10g; mg/10g 66184-510_f6cc5b60-ad4d-4a9e-92fe-2f382a569b25 66184-510 HUMAN OTC DRUG ck one airlight pressed powder spf 15 tan 500 Titanium Dioxide POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; ZINC OXIDE 1.475; 100 mg/10g; mg/10g 66184-515_e58eb419-134e-4af1-b551-af66182a469d 66184-515 HUMAN OTC DRUG ck one airlight pressed powder spf 15 honey 600 Titanium Dioxide POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; ZINC OXIDE 1.475; 100 mg/10g; mg/10g 66184-520_7394e4ce-11f4-49d4-a8df-6525d4981af8 66184-520 HUMAN OTC DRUG ck one airlight pressed powder spf 15 caramel 700 Titanium Dioxide POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; ZINC OXIDE 1.475; 100 mg/10g; mg/10g 66184-525_d9e3549f-83ae-4785-8044-0f77a5e77a08 66184-525 HUMAN OTC DRUG ck one airlight pressed powder spf 15 cappuccino 700 Titanium Dioxide POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; ZINC OXIDE 1.475; 100 mg/10g; mg/10g 66184-526_e31ae71d-f095-408b-a910-76633f993b19 66184-526 HUMAN OTC DRUG ck one all day perfection face makeup spf 20 sunscreen 050 Ivory Titanium Dioxide and Octinoxate LOTION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .999; 1.648359 g/30mL; g/30mL 66184-527_7311bdc8-6e79-4ab7-8d17-09880f88ec6b 66184-527 HUMAN OTC DRUG ck one all day perfection face makeup spf 20 sunscreen Titanium Dioxide and Octinoxate LOTION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .999; 1.648359 g/30mL; g/30mL 66184-528_3be15f7f-21fa-4269-83a3-32e6484ebdee 66184-528 HUMAN OTC DRUG ck one all day perfection face makeup spf 20 sunscreen 100 Porcelain Titanium Dioxide and Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .999; 1.648359 g/30mL; g/30mL 66184-529_e0aa0900-284d-44b5-9a47-fa83fdc5e89c 66184-529 HUMAN OTC DRUG ck one all day perfection face makeup spf 20 sunscreen 300 Sand Titanium Dioxide and Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .999; 1.648359 g/30mL; g/30mL 66184-530_d46c2ef4-e883-4c59-9d81-b5260de37fa5 66184-530 HUMAN OTC DRUG ck one all day perfection face makeup spf 20 sunscreen 350 Warm Sand Titanium Dioxide and Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .999; 1.648359 g/30mL; g/30mL 66184-531_9f754fb4-d1ea-4e71-b13c-a181559a42b8 66184-531 HUMAN OTC DRUG ck one all day perfection face makeup spf 20 sunscreen 400 Bisque Titanium Dioxide and Octinoxate LOTION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .999; 1.648359 g/30mL; g/30mL 66184-532_c1d7827a-aac0-415f-8862-39a4aee899c3 66184-532 HUMAN OTC DRUG ck one all day perfection face makeup spf 20 sunscreen 500 Tan Titanium Dioxide and Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .999; 1.648359 g/30mL; g/30mL 66184-533_0e06b90d-6afd-4120-9dbe-b2905e440b89 66184-533 HUMAN OTC DRUG ck one all day perfection face makeup spf 20 sunscreen 600 Honey Titanium Dioxide and Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Coty US LLC OCTINOXATE; TITANIUM DIOXIDE .999; 1.648359 g/30mL; g/30mL 66213-115_a8c5db51-e8b2-4594-8b05-aaa78ca0682d 66213-115 HUMAN PRESCRIPTION DRUG Compazine Prochlorperazine Maleate TABLET, FILM COATED ORAL 20140401 ANDA ANDA040120 PBM Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 66213-117_a8c5db51-e8b2-4594-8b05-aaa78ca0682d 66213-117 HUMAN PRESCRIPTION DRUG Compazine Prochlorperazine Maleate TABLET, FILM COATED ORAL 20140401 ANDA ANDA040120 PBM Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 66213-200_284067bf-3b79-49ac-aae3-5a1cf182216d 66213-200 HUMAN PRESCRIPTION DRUG Compazine Prochlorperazine SUPPOSITORY RECTAL 20130701 ANDA ANDA040246 PBM Pharmaceuticals, Inc PROCHLORPERAZINE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 66213-421_03a3609f-520f-4e7b-8d7b-1652881723c0 66213-421 HUMAN PRESCRIPTION DRUG Donnatal Extentabs Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080507 UNAPPROVED DRUG OTHER PBM Pharmaceuticals, Inc ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0582; .3111; 48.6; .0195 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 66213-422_09f51f78-ba70-4753-a0ae-9574cf22c9e0 66213-422 HUMAN PRESCRIPTION DRUG Donnatal PHENOBARBITAL ELIXIR ELIXIR ORAL 20110701 UNAPPROVED DRUG OTHER PBM Pharmaceuticals Inc. ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 66213-422_fcbb3938-fca3-4ed6-96e4-446b7cdef5d6 66213-422 HUMAN PRESCRIPTION DRUG Donnatal phenobarbital elixir ELIXIR ORAL 20110701 UNAPPROVED DRUG OTHER PBM Pharmaceuticals Inc. ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 66213-423_5357c5a7-6413-4ece-9bde-c08763c19f50 66213-423 HUMAN PRESCRIPTION DRUG Donnatal PHENOBARBITAL ELIXIR ELIXIR ORAL 20091101 UNAPPROVED DRUG OTHER PBM Pharmaceuticals Inc. ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 66213-423_f2607865-8e51-4fc8-a703-b9eb499f890d 66213-423 HUMAN PRESCRIPTION DRUG Donnatal PHENOBARBITAL ELIXIR ELIXIR ORAL 20091101 UNAPPROVED DRUG OTHER PBM Pharmaceuticals Inc. ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 66213-425_05653083-535e-473b-bd53-e17df9ddc1dd 66213-425 HUMAN PRESCRIPTION DRUG Donnatal PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE TABLET ORAL 20080507 UNAPPROVED DRUG OTHER PBM Pharmaceuticals Inc. ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 66213-542_b4abec8b-4e5a-4374-bb05-bebd71523c96 66213-542 HUMAN PRESCRIPTION DRUG Animi-3 with Vitamin D Folic Acid, Cholecalciferol, Pyridoxine Hydrochloride, Cyanocobalamin, Omega-3 Fatty Acids, Doconexent, Icosapent CAPSULE ORAL 20110601 UNAPPROVED DRUG OTHER PBM Pharmaceuticals, Inc CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FOLIC ACID; ICOSAPENT; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; SOY STEROL 1000; 500; 250; 1; 35; 500; 12.5; 200 [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] 66213-543_5e947d00-9af4-4632-bca3-e8b30ce39100 66213-543 HUMAN PRESCRIPTION DRUG Animi-3 Folic Acid, Cholecalciferol, Pyridoxine Hydrochloride, Cyanocobalamin, Omega-3 Fatty Acids, Doconexent, Icosapent, Phytosterols CAPSULE ORAL 20110601 UNAPPROVED DRUG OTHER PBM Pharmaceuticals, Inc CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FOLIC ACID; ICOSAPENT; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; SOY STEROL 1000; 500; 250; 1; 35; 500; 12.5; 200 [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 66215-016_169135a6-04bf-48ff-a5c9-8d90baa79bb5 66215-016 HUMAN PRESCRIPTION DRUG VALCHLOR mechlorethamine hydrochloride GEL TOPICAL 20131021 NDA NDA202317 Actelion Pharmaceuticals US, Inc. MECHLORETHAMINE .012 g/60g Alkylating Activity [MoA],Alkylating Drug [EPC] 66215-101_569ae365-529f-42d0-a721-f40f4a396e52 66215-101 HUMAN PRESCRIPTION DRUG Tracleer bosentan TABLET, FILM COATED ORAL 20011120 NDA NDA021290 Actelion Pharmaceuticals US, Inc. BOSENTAN 62.5 mg/1 Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA] 66215-102_569ae365-529f-42d0-a721-f40f4a396e52 66215-102 HUMAN PRESCRIPTION DRUG Tracleer bosentan TABLET, FILM COATED ORAL 20011120 NDA NDA021290 Actelion Pharmaceuticals US, Inc. BOSENTAN 125 mg/1 Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA] 66215-201_54c867b3-b9f5-47fa-a845-ec581f855a35 66215-201 HUMAN PRESCRIPTION DRUG Zavesca miglustat CAPSULE ORAL 20030731 NDA NDA021348 Actelion Pharmaceuticals US, Inc. MIGLUSTAT 100 mg/1 Glucosylceramide Synthase Inhibitor [EPC],Glucosylceramide Synthase Inhibitors [MoA] 66215-302_4cd9977f-d5eb-4a6e-a833-9e980e807fdb 66215-302 HUMAN PRESCRIPTION DRUG Ventavis iloprost SOLUTION RESPIRATORY (INHALATION) 20050507 NDA NDA021779 Actelion Pharmaceuticals US, Inc. ILOPROST .01 mg/mL Prostacycline [EPC],Prostaglandins I [Chemical/Ingredient] 66215-303_4cd9977f-d5eb-4a6e-a833-9e980e807fdb 66215-303 HUMAN PRESCRIPTION DRUG Ventavis iloprost SOLUTION RESPIRATORY (INHALATION) 20090824 NDA NDA021779 Actelion Pharmaceuticals US, Inc. ILOPROST .02 mg/mL Prostacycline [EPC],Prostaglandins I [Chemical/Ingredient] 66215-401_c21fe239-6ac6-46a2-b97c-84d9ad1a5c98 66215-401 HUMAN PRESCRIPTION DRUG Veletri epoprostenol sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100422 NDA NDA022260 Actelion Pharmaceuticals US, Inc. EPOPROSTENOL SODIUM 1500000 ng/10mL Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] 66215-402_2338f36d-d36f-4f71-8584-2490394e7b03 66215-402 HUMAN PRESCRIPTION DRUG Veletri epoprostenol INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100422 NDA NDA022260 Actelion Pharmaceuticals US, Inc. EPOPROSTENOL 1500000 ng/10mL Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] 66215-403_2338f36d-d36f-4f71-8584-2490394e7b03 66215-403 HUMAN PRESCRIPTION DRUG Veletri epoprostenol INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100422 NDA NDA022260 Actelion Pharmaceuticals US, Inc. EPOPROSTENOL 500000 ng/10mL Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] 66215-501_ca323db7-6e33-4584-a72a-70dbce196d7d 66215-501 HUMAN PRESCRIPTION DRUG OPSUMIT macitentan TABLET, FILM COATED ORAL 20131001 NDA NDA204410 Actelion Pharmaceuticals US, Inc. MACITENTAN 10 mg/1 Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA] 66220-160_84734a3c-6a8f-4688-abd4-573d20a6b0cf 66220-160 HUMAN PRESCRIPTION DRUG VAPRISOL DEXTROSE IN PLASTIC CONTAINER conivaptan hydrochloride INJECTION, SOLUTION INTRAVENOUS 20081008 NDA NDA021697 Cumberland Pharmaceuticals Inc. CONIVAPTAN HYDROCHLORIDE 20 mg/100mL Antidiuretic Hormone Antagonists [MoA],Vasopressin Antagonist [EPC] 66220-207_74796172-7d5d-4e77-beec-fcde5c1b5cab 66220-207 HUMAN PRESCRIPTION DRUG ACETADOTE Acetylcysteine INJECTION, SOLUTION INTRAVENOUS 20110122 NDA NDA021539 Cumberland Pharmaceuticals Inc. ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 66220-287_a8e3ca83-b736-4ec6-868b-48f5e40ad3c5 66220-287 HUMAN PRESCRIPTION DRUG Caldolor ibuprofen INJECTION INTRAVENOUS 20090611 NDA NDA022348 Cumberland Pharmaceuticals Inc. IBUPROFEN 100 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66220-719_345383dc-2e49-462c-b304-d49c3be6783e 66220-719 HUMAN PRESCRIPTION DRUG Kristalose lactulose POWDER, FOR SOLUTION ORAL 20120120 ANDA ANDA074712 Cumberland Pharmaceuticals Inc. LACTULOSE 10 g/10g Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 66220-729_345383dc-2e49-462c-b304-d49c3be6783e 66220-729 HUMAN PRESCRIPTION DRUG Kristalose lactulose POWDER, FOR SOLUTION ORAL 20120120 ANDA ANDA074712 Cumberland Pharmaceuticals Inc. LACTULOSE 20 g/20g Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 66222-0001_f9ed7960-4a85-45aa-8e48-68c9991e93d7 66222-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20010209 UNAPPROVED MEDICAL GAS JCMH Home Health Products OXYGEN 99 L/100L 66228-001_0427d2a2-64d2-4993-966f-d5ade0d01383 66228-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19910401 NDA NDA206023 CLAY COUNTY HOSPITAL DME OXYGEN 990 1/L 66259-424_590fdd52-5a49-4cc1-bba1-3d0f235e85ab 66259-424 HUMAN PRESCRIPTION DRUG Indocyanine green Indocyanine green INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120701 ANDA ANDA040811 Novadaq Technologies Inc. INDOCYANINE GREEN 25 mg/1 66259-701_b346daf5-b33e-4d8f-b031-f8bc34c0e1dd 66259-701 HUMAN PRESCRIPTION DRUG IC-Green Indocyanine Green INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130925 NDA NDA011525 Novadaq Technologies Inc. INDOCYANINE GREEN 25 mg/1 66273-0001_357f1627-0281-4a30-be09-9ae2933be6d8 66273-0001 HUMAN OTC DRUG EXENCE WHITE HYDROQUINONE CREAM CUTANEOUS 20110712 OTC MONOGRAPH NOT FINAL part358A AQUIMPEX SPA HYDROQUINONE 4 mL/200mL 66273-0002_f8f3f653-d438-47d5-a846-918652369467 66273-0002 HUMAN OTC DRUG EXENCE WHITE HYDROQUINONE LOTION CUTANEOUS 20110712 OTC MONOGRAPH NOT FINAL part358A AQUIMPEX SPA HYDROQUINONE 4 mL/200mL 66273-0003_aed6d52b-47fb-4d19-8c4d-c81e20d104f7 66273-0003 HUMAN OTC DRUG CLEAR ACTION HYDROQUINONE CREAM CUTANEOUS 20110719 OTC MONOGRAPH NOT FINAL part358A AQUIMPEX SPA HYDROQUINONE 10 mL/500mL 66273-0004_f8ccdf5e-20ce-490a-bb5c-be34b30444e4 66273-0004 HUMAN OTC DRUG CLEAR ACTION HYDROQUINONE LOTION CUTANEOUS 20110719 OTC MONOGRAPH NOT FINAL part358A AQUIMPEX SPA HYDROQUINONE 10 mL/500mL 66288-1100_f620fe7d-90ba-49d4-a035-1eb1366e34ce 66288-1100 HUMAN PRESCRIPTION DRUG CEFAZOLIN CEFAZOLIN SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20070101 ANDA ANDA065141 Samson Medical Technologies, L.L.C. CEFAZOLIN SODIUM 100 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 66288-1300_f620fe7d-90ba-49d4-a035-1eb1366e34ce 66288-1300 HUMAN PRESCRIPTION DRUG CEFAZOLIN CEFAZOLIN SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20070101 ANDA ANDA065141 Samson Medical Technologies, L.L.C. CEFAZOLIN SODIUM 300 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 66288-2075_055f264a-ca6d-4866-81c2-6b2898460880 66288-2075 HUMAN PRESCRIPTION DRUG Cefuroxime Sodium Cefuroxime Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100201 ANDA ANDA065251 Samson Medical Technologies, L.L.C. CEFUROXIME SODIUM 75 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 66288-2225_055f264a-ca6d-4866-81c2-6b2898460880 66288-2225 HUMAN PRESCRIPTION DRUG Cefuroxime Sodium Cefuroxime Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100201 ANDA ANDA065251 Samson Medical Technologies, L.L.C. CEFUROXIME SODIUM 225 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 66288-6100_5cd2d96f-83e5-4326-ae87-d0ede4ba493a 66288-6100 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140630 ANDA ANDA090057 Samson Medical Technologies, LLC CEFTRIAXONE SODIUM 100 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 66291-001_98d450d5-db50-42e9-a7bc-f9a9b3cf1b17 66291-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19910101 UNAPPROVED MEDICAL GAS The 3700 Company LLC dba Air Options Respiratory Care OXYGEN 99 L/100L 66302-101_3f5cc113-28d7-4b1c-a89a-89c502ebce3b 66302-101 HUMAN PRESCRIPTION DRUG Remodulin treprostinil INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20020522 NDA NDA021272 United Therapeutics Corporation TREPROSTINIL 20 mg/20mL Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] 66302-102_3f5cc113-28d7-4b1c-a89a-89c502ebce3b 66302-102 HUMAN PRESCRIPTION DRUG Remodulin treprostinil INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20020522 NDA NDA021272 United Therapeutics Corporation TREPROSTINIL 50 mg/20mL Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] 66302-105_3f5cc113-28d7-4b1c-a89a-89c502ebce3b 66302-105 HUMAN PRESCRIPTION DRUG Remodulin treprostinil INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20020522 NDA NDA021272 United Therapeutics Corporation TREPROSTINIL 100 mg/20mL Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] 66302-110_3f5cc113-28d7-4b1c-a89a-89c502ebce3b 66302-110 HUMAN PRESCRIPTION DRUG Remodulin treprostinil INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20020522 NDA NDA021272 United Therapeutics Corporation TREPROSTINIL 200 mg/20mL Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] 66302-206_2bb6d2ff-a260-4fb8-864e-464b304b1517 66302-206 HUMAN PRESCRIPTION DRUG TYVASO treprostinil INHALANT ORAL 20090814 NDA NDA022387 United Therapeutics Corp. TREPROSTINIL 1.74 mg/2.9mL Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] 66302-300_bc508fd7-4700-4e18-ad43-9ccea53eeac5 66302-300 HUMAN PRESCRIPTION DRUG Orenitram treprostinil TABLET, EXTENDED RELEASE ORAL 20131220 NDA NDA203496 United Therapeutics Corp. TREPROSTINIL .125 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] 66302-302_bc508fd7-4700-4e18-ad43-9ccea53eeac5 66302-302 HUMAN PRESCRIPTION DRUG Orenitram treprostinil TABLET, EXTENDED RELEASE ORAL 20131220 NDA NDA203496 United Therapeutics Corp. TREPROSTINIL .25 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] 66302-310_bc508fd7-4700-4e18-ad43-9ccea53eeac5 66302-310 HUMAN PRESCRIPTION DRUG Orenitram treprostinil TABLET, EXTENDED RELEASE ORAL 20131220 NDA NDA203496 United Therapeutics Corp. TREPROSTINIL 1 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] 66302-325_bc508fd7-4700-4e18-ad43-9ccea53eeac5 66302-325 HUMAN PRESCRIPTION DRUG Orenitram treprostinil TABLET, EXTENDED RELEASE ORAL 20131220 NDA NDA203496 United Therapeutics Corp. TREPROSTINIL 2.5 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] 66302-467_29997d3f-4861-415a-bc8f-570622a53b48 66302-467 HUMAN PRESCRIPTION DRUG ADCIRCA Tadalafil TABLET ORAL 20090522 NDA NDA022332 United Therapeutics Corporation TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 66312-110_a5e6a6c7-c452-45fa-94f2-aae8391de28b 66312-110 HUMAN PRESCRIPTION DRUG Oraqix lidocaine and prilocaine GEL PERIODONTAL 20040102 NDA NDA021451 DENTSPLY Pharmaceutical LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 66312-176_9d5805cb-aac8-467a-9f17-928007a5e74f 66312-176 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 19850122 NDA NDA088390 Dentsply Pharmaceutical EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE 10; 20 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 66312-181_9d5805cb-aac8-467a-9f17-928007a5e74f 66312-181 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 19850122 NDA NDA088389 Dentsply Pharmaceutical EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE 20; 20 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 66312-441_f9e8985b-3062-4f13-bf13-61355de3f41e 66312-441 HUMAN PRESCRIPTION DRUG Polocaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 19841010 NDA NDA088387 Dentsply Pharmaceutical MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 66312-540_45057970-f6b8-4b63-866d-8526a753d59b 66312-540 HUMAN PRESCRIPTION DRUG Citanest Forte prilocaine hydrochloride and epinephrine bitartrate INJECTION, SOLUTION DENTAL 19651118 NDA NDA021383 Dentsply Pharmaceutical Inc. EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE .005; 40 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 66312-601_d5b5d6b5-0148-44f7-8486-e3599cff2c5a 66312-601 HUMAN PRESCRIPTION DRUG Articadent Articaine hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20000403 NDA NDA020971 Dentsply Pharmaceutical ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .01 mg/mL; mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 66312-602_d5b5d6b5-0148-44f7-8486-e3599cff2c5a 66312-602 HUMAN PRESCRIPTION DRUG Articadent Articaine hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20000403 NDA NDA020971 Dentsply Pharmaceutical ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 66312-630_bc17490e-2f2b-44c2-b6d0-d92c5717144c 66312-630 HUMAN PRESCRIPTION DRUG Citanest Plain prilocaine hydrochloride INJECTION, SOLUTION DENTAL 19651118 ANDA ANDA079235 Dentsply Pharmaceutical Inc. PRILOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 66314-001_d5bf5610-0579-4922-af21-13e01766cd69 66314-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Med Resources, Inc. OXYGEN 99 L/100L 66336-002_9a13b0e4-5d05-4eb8-91f7-642e45d95d50 66336-002 HUMAN OTC DRUG good sense all day pain relief Naproxen Sodium TABLET ORAL 19970114 ANDA ANDA074661 Dispensing Solutions, Inc. NAPROXEN SODIUM 220 mg/1 66336-010_a7810248-3b03-4564-a0b8-cee4637d8254 66336-010 HUMAN OTC DRUG EXTRA STRENGTH STOOL SOFTENER LAXATIVE DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120329 OTC MONOGRAPH NOT FINAL part334 Dispensing Solutions, Inc. DOCUSATE SODIUM 250 mg/1 66336-012_e0e97c61-89c6-4f1c-9d3d-5cff90cf40c5 66336-012 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19960229 ANDA ANDA040144 Dispensing Solutions, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 66336-019_8f22cff6-3614-4217-9339-754ad3855309 66336-019 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19960229 ANDA ANDA040144 Dispensing Solutions, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 66336-027_1063e26b-f183-465a-b3a7-dac7e5ee3c67 66336-027 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Dispensing Solutions, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 66336-028_a4fd73f5-7135-4508-a332-4431daad6bdc 66336-028 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Dispensing Solutions, Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 66336-030_2956210a-1b0b-4b63-bf6f-2de8f1374380 66336-030 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Dispensing Solutions, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66336-033_c55cb2d2-2cba-4ca3-b0ef-50c003b920de 66336-033 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Dispensing Solutions, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 66336-046_f9d114cb-c8ad-4660-ba45-4c08e60839d0 66336-046 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20110923 ANDA ANDA073192 Dispensing Solutions, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 66336-047_ed7a1b9f-57f7-40df-9fdc-89810fbb5547 66336-047 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 Dispensing Solutions, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 66336-052_1397062c-64a5-49b9-b3f3-fe7c0edd8f7a 66336-052 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Dispensing Solutions, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 66336-055_72c74c12-f8d9-47e4-968c-95591f7766d2 66336-055 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Dispensing Solutions, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 66336-056_ec976214-bd1c-4319-b472-98e6cf831c78 66336-056 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20080606 ANDA ANDA077239 Dispensing Solutions, Inc. ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 66336-058_5806e4cf-77b1-4d57-8ce8-ef11dc30144c 66336-058 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA084122 Dispensing Solutions, Inc. PREDNISONE 10 mg/1 66336-058_cb2e8970-aff2-4196-87de-29b458336284 66336-058 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA084122 Dispensing Solutions, Inc. PREDNISONE 10 mg/1 66336-059_30993951-a2b3-4106-9ff1-639c17d8ff0e 66336-059 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 Dispensing Solutions, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII 66336-063_d4f90f31-4a9f-43c4-8ade-5841fc60f0f3 66336-063 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Dispensing Solutions, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 66336-074_3fe12e39-1a78-4177-b703-cad97bcd26b4 66336-074 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20060329 ANDA ANDA065255 Dispensing Solutions, Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 66336-080_58228cbd-44f7-4482-ab77-df7e4e60b688 66336-080 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Dispensing Solutions, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 66336-085_3dfdb1c3-342c-411c-a214-4d0ebeb6be8c 66336-085 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20060718 ANDA ANDA040622 Dispensing Solutions, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 66336-086_0b50bcf8-f907-4d0b-90a2-19498757fe36 66336-086 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20050527 ANDA ANDA040574 Dispensing Solutions, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 66336-094_b8c45bf4-669b-434a-a646-9891555c263d 66336-094 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 Dispensing Solutions, Inc. PREDNISONE 20 mg/1 66336-096_7b4582e6-e63b-49a6-ab60-608ef3897946 66336-096 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET ORAL 19941001 OTC MONOGRAPH FINAL part341 Dispensing Solutions, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 66336-099_4473f13c-d981-44d8-88cf-8976a911727f 66336-099 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20091201 ANDA ANDA077918 Dispensing Solutions, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66336-106_1405c0fe-a865-445f-940f-52db142784a4 66336-106 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19960412 ANDA ANDA040157 Dispensing Solutions, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 66336-115_34dce80b-24b6-4df8-b006-de2d135efbc0 66336-115 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Dispensing Solutions, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 66336-115_562fa13f-1a38-40f0-8ac4-8de2a46ed25e 66336-115 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Dispensing Solutions, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 66336-127_753fe817-2105-4f60-8144-5f2560496201 66336-127 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20071003 ANDA ANDA077410 Dispensing Solutions, Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 66336-135_697f587f-f37e-4ed2-9d54-dd346766346c 66336-135 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20090730 ANDA ANDA076758 Dispensing Solutions, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 66336-147_9c4d3166-fb57-445e-b13e-1d19a0a5b0cb 66336-147 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20110308 ANDA ANDA040545 Dispensing Solutions, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 66336-168_0e4c59f8-9fb0-42b3-9464-10d4c54b0289 66336-168 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 Dispensing Solutions, Inc. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 66336-184_5f07db7c-c369-4635-b44c-6cd2a75aca8a 66336-184 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20030329 ANDA ANDA040412 Dispensing Solutions, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 66336-185_fe6e20b4-0ab2-4ff4-8992-2f3ac8eac2ce 66336-185 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE ORAL 19980601 ANDA ANDA040875 Dispensing Solutions, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 66336-187_3899134c-fa4f-435f-9786-ffc605963e1b 66336-187 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Dispensing Solutions, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 66336-214_cf313cc0-44c0-4f55-a021-8fab00af41ca 66336-214 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, FILM COATED ORAL 20071012 NDA NDA022145 Dispensing Solutions, Inc. RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] 66336-219_ce688852-a790-4180-92db-b83cbdab8c3d 66336-219 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087801 Dispensing Solutions, Inc. PREDNISONE 2.5 mg/1 66336-224_0a4641d5-de81-4696-a35b-9d2174a347a5 66336-224 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Dispensing Solutions, Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 66336-233_8e39026d-40d6-4235-8422-08408281f3f6 66336-233 HUMAN OTC DRUG Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Dispensing Solutions, Inc. ACETAMINOPHEN 650 mg/1 66336-238_ef637460-8812-461e-a394-21a610bbebd4 66336-238 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Dispensing Solutions, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66336-269_4bbb1030-1e27-4761-9414-2a1f3384894a 66336-269 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031101 ANDA ANDA076467 Dispensing Solutions, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 66336-316_4f00b5a8-165b-4081-99c7-a33bf3273416 66336-316 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Dispensing Solutions, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66336-336_64486ca9-85d5-40d1-9a5b-01d52521ed7b 66336-336 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077946 Dispensing Solutions, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 66336-337_9e8fb504-77b7-4765-9191-aadff6316cd5 66336-337 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM ANHYDROUS .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 66336-338_1239c290-23b1-4b83-97b9-d9e5e45fa30b 66336-338 HUMAN PRESCRIPTION DRUG METHOTREXATE METHOTREXATE TABLET ORAL 19531207 NDA NDA008085 Dispensing Solutions, Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 66336-340_d26d25bc-6674-4a2a-b6b1-46beec6554b6 66336-340 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 66336-341_d26d25bc-6674-4a2a-b6b1-46beec6554b6 66336-341 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 66336-342_d26d25bc-6674-4a2a-b6b1-46beec6554b6 66336-342 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 66336-344_9705bec8-2f8d-4aa0-9009-7b4e83077958 66336-344 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040527 Dispensing Solutions, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 66336-354_00c820ad-3f5e-4a79-a864-4e674da6f285 66336-354 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Dispensing Solutions, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 66336-357_9e8fb504-77b7-4765-9191-aadff6316cd5 66336-357 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20071001 NDA NDA021210 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM ANHYDROUS .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 66336-363_7ed5ee28-ccc4-43ea-8c05-4626e0c9fae2 66336-363 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070103 ANDA ANDA071403 Dispensing Solutions, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 66336-367_b8ad55d8-697c-4859-b1b9-56e2c7ee8260 66336-367 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20060727 ANDA ANDA077836 Dispensing Solutions, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 66336-377_5c6c99d0-578e-49a1-847d-4b1f7cceaab6 66336-377 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063065 Dispensing Solution, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 66336-393_fe36b318-a80b-4c21-9280-0a50e441dafb 66336-393 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Dispensing Solutions, Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 66336-402_f2b44f85-db0d-46e4-9fa0-282203cc6578 66336-402 HUMAN PRESCRIPTION DRUG Methergine methylergonovine maleate TABLET, COATED ORAL 19461119 NDA NDA006035 Dispensing Solutions, Inc. METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 66336-406_04707455-a0b9-41ce-9b94-fd416ad2aaf8 66336-406 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19960222 ANDA ANDA040143 Dispensing Solutions, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 66336-408_a97c38c3-d6af-44e0-94ba-e8457f992469 66336-408 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040356 Dispensing Solutions, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 66336-427_9e8fb504-77b7-4765-9191-aadff6316cd5 66336-427 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM ANHYDROUS .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 66336-428_cb2e8970-aff2-4196-87de-29b458336284 66336-428 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087800 Dispensing Solutions, Inc. PREDNISONE 1 mg/1 66336-429_5afb5523-36b4-4def-af52-36cc92d187a9 66336-429 HUMAN PRESCRIPTION DRUG clarithromycin clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080101 ANDA ANDA065145 Dispensing Solutions, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 66336-430_2956210a-1b0b-4b63-bf6f-2de8f1374380 66336-430 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Dispensing Solutions, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66336-437_7da07df7-0b87-4c0d-9600-1d9189391587 66336-437 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 Dispensing Solutions, Inc. ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 66336-439_7d9f35d2-ad0e-415c-b145-10382b7b5a7f 66336-439 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 Dispensing Solutions, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 66336-442_c2b43b77-8ebb-4559-aaae-2d17741bce3e 66336-442 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19881202 ANDA ANDA089971 Dispensing Solutions, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 66336-444_90381683-704b-410f-91ad-1a5c41fcf657 66336-444 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 Dispensing Solutions, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 66336-460_72ea5fd8-73c4-47a8-976c-3245bba15f11 66336-460 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Dispensing Solutions, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 66336-463_2925c37a-365e-472b-ac2c-6216247d7bd2 66336-463 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Dispensing Solutions, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66336-470_697f587f-f37e-4ed2-9d54-dd346766346c 66336-470 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20090730 ANDA ANDA076758 Dispensing Solutions, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 66336-478_3b4adae5-b1f7-4df1-a3d5-d7aea1200059 66336-478 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Dispensing Solutions, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 66336-479_22d12fc3-c111-4b1a-908e-f65725378066 66336-479 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 Dispensing Solutions, Inc. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 66336-486_9b60cb0d-4259-49dc-8b29-0dcf504cf40f 66336-486 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077068 Dispensing Solutions, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 66336-488_891a2078-2804-4766-98fe-584fe503b34d 66336-488 HUMAN OTC DRUG ED A-HIST CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20111008 OTC MONOGRAPH FINAL part341 Dispensing Solutions, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 66336-502_f7aa7607-6319-4a5e-9a21-3a3e97b2e499 66336-502 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080317 NDA NDA022207 Dispensing Solutions, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 66336-533_1635b9ca-beee-46ec-97a9-2cda23cad167 66336-533 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100628 ANDA ANDA090568 Dispensing Solutions, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 66336-536_7604a761-8bd8-49de-a2be-4ef59212f0dd 66336-536 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 66336-537_7604a761-8bd8-49de-a2be-4ef59212f0dd 66336-537 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 66336-554_4a306212-0548-4ad5-9885-2198944bc6f5 66336-554 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Dispensing Solutions, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 66336-555_450d00fd-2711-4689-9fb3-1e6cac7fafb7 66336-555 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20090107 ANDA ANDA040766 Dispensing Solutions, Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 66336-556_2956210a-1b0b-4b63-bf6f-2de8f1374380 66336-556 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Dispensing Solutions, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66336-558_3ecd7b1f-5aef-41b8-8ab7-1897f87c347c 66336-558 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19860710 ANDA ANDA062676 Dispensing Solutions, Inc. DOXYCYCLINE HYCLATE 50 mg/1 66336-560_368c7e88-5379-430b-b396-18a6b34cb10d 66336-560 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20110808 ANDA ANDA076447 Dispensing Solutions, Inc. FEXOFENADINE HYDROCHLORIDE 60 mg/1 66336-561_7c798476-f38e-40df-8755-a0edc055ec21 66336-561 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Dispensing Solutions, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 66336-566_02ba1d7c-aeef-452b-b748-6ecc1d88e340 66336-566 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Dispensing Solutions, Inc. TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 66336-567_7d9f35d2-ad0e-415c-b145-10382b7b5a7f 66336-567 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 Dispensing Solutions, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 66336-570_9edeab5c-754e-4739-89c1-a47f7a7f9873 66336-570 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20101201 ANDA ANDA076077 Dispensing Solutions, Inc. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 66336-571_1ec9d9bb-619a-461f-b5ff-8ea35a02b3f9 66336-571 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 66336-572_e920b01c-e21f-434e-b760-6dbd1b187ef6 66336-572 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20061002 ANDA ANDA077912 Dispensing Solutions, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 66336-579_fbb3d03a-51e4-4e49-99c3-c8ad36737d28 66336-579 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071134 Dispensing Solutions, Inc. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 66336-581_09c8569c-3a69-4d0b-8dd5-7c66bc47d534 66336-581 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19890503 ANDA ANDA071611 Dispensing Solutions, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 66336-586_221b9a3d-d734-443f-94b4-270a4d90fcc9 66336-586 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20010209 ANDA ANDA075665 Dispensing Solutions, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66336-588_31703dcf-5f13-4729-8e4d-9ed581b4cfd9 66336-588 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Dispensing Solutions, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 66336-591_c12f402b-f00b-466d-a6ea-862f00f81ec7 66336-591 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 66336-600_ecb43b12-9ed4-45f7-8eb3-a03b985e912c 66336-600 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20010525 NDA NDA021301 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 66336-601_ecb43b12-9ed4-45f7-8eb3-a03b985e912c 66336-601 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20010525 NDA NDA021301 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 66336-602_e395e4b2-97f1-4910-b1d6-024b2020d9c3 66336-602 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Dispensing Solutions, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66336-603_9e7d698d-43c2-4ea4-b5ae-298d3bc2f4d6 66336-603 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 20110118 ANDA ANDA040159 Dispensing Solutions, Inc. MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 66336-604_95753e38-0d1c-410c-9d1e-7e09dea1437c 66336-604 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20070511 ANDA ANDA076745 Dispensing Solutions, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 66336-608_15395dfd-3685-45ef-bbcb-13f95dcedf4d 66336-608 HUMAN PRESCRIPTION DRUG misoprostol MISOPROSTOL TABLET ORAL 20091227 NDA AUTHORIZED GENERIC NDA019268 Dispensing Solutions, Inc. MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 66336-619_9b1cedc1-d578-4e5e-a130-21dca030f666 66336-619 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine TABLET ORAL 19790605 ANDA ANDA086162 Dispensing Solutions, Inc. ASPIRIN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 66336-620_f78847e5-3b80-4508-b030-452441c74a4e 66336-620 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110120 ANDA ANDA071523 Dispensing Solutions, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 66336-623_5c5af70c-6daf-4514-823e-b089adc31785 66336-623 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20120116 ANDA ANDA040734 Dispensing Solutions, Inc. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 66336-624_8e2fad31-7e6d-426c-b2f4-487d870f2374 66336-624 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20100618 NDA NDA021906 Dispensing Solutions, Inc. LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA] 66336-635_ddc02aa9-0009-49f7-9efc-d52acf1eacd6 66336-635 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 Dispensing Solutions, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 66336-663_5270706a-c8eb-47c1-9650-e80d26407ba8 66336-663 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET OCCLUSIVE DRESSING TECHNIQUE 20081223 ANDA ANDA089859 Dispensing Solutions, Inc. CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 66336-665_e1947fbe-c5d4-4f6c-b364-a4734ff91775 66336-665 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101228 ANDA ANDA076958 Dispensing Solutions, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 66336-666_e1947fbe-c5d4-4f6c-b364-a4734ff91775 66336-666 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101228 ANDA ANDA076958 Dispensing Solutions, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 66336-669_d3212136-8ef9-4e20-9395-27f5bf63e5ca 66336-669 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Dispensing Solutions, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 66336-670_37836856-4c09-43d3-ba39-f42da6614a05 66336-670 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 Dispensing Solutions, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 66336-673_0a4641d5-de81-4696-a35b-9d2174a347a5 66336-673 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Dispensing Solutions, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 66336-687_8af5d40d-42f1-4201-9ec6-bd96efcd6e3a 66336-687 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20101206 ANDA ANDA091549 Dispensing Solutions, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66336-706_64218455-e1e2-4e40-bd32-5002d2d1555d 66336-706 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20121212 ANDA ANDA075876 Dispensing Solutions, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 66336-712_57076caf-0ccd-484f-9e80-8bd934593387 66336-712 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19990512 ANDA ANDA074686 Dispensing Solutions, Inc. GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 66336-718_09e0c026-4724-4844-8c63-a4bb5f5d068b 66336-718 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Dispensing Solutions, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 66336-718_e0d2aa04-ee64-4806-9ef0-7a79cd869aa7 66336-718 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Dispensing Solutions, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 66336-720_201a5bf4-905f-4a4f-856b-114f90dce681 66336-720 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET, FILM COATED ORAL 20110906 ANDA ANDA090199 Dispensing Solutions, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 66336-722_07a2440f-fa26-4502-bd79-f4c6d1942c8c 66336-722 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET ORAL 20010131 ANDA ANDA075845 Dispensing Solutions, Inc. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66336-748_877be95b-3967-4f8b-b8d7-686fd27c9b21 66336-748 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19970414 ANDA ANDA040155 Dispensing Solutions, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 66336-774_b755804d-e016-433c-bb54-760ad571e5af 66336-774 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20091201 ANDA ANDA077918 Dispensing Solutions, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66336-776_b32626f0-8320-437e-ae46-1c265f73fb32 66336-776 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040742 Dispensing Solutions, Inc. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 66336-786_bdaaa82c-2eae-48cb-832f-4a7f4b2c1fd6 66336-786 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Dispensing Solutions, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 66336-792_fb030a15-7594-4ab1-8162-5ca19944229f 66336-792 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Dispensing Solutions, Inc. DOCUSATE SODIUM 100 mg/1 66336-793_ace9dc28-4a9d-4e37-b445-564afb44b268 66336-793 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Dispensing Solutions, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 66336-800_ed7a1b9f-57f7-40df-9fdc-89810fbb5547 66336-800 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070108 ANDA ANDA071141 Dispensing Solutions, Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 66336-801_c6ad56eb-e84c-457a-becd-9ae66729cedd 66336-801 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20110501 NDA NDA021342 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 66336-815_f9f24b7c-2184-463c-bd18-70edd0b271db 66336-815 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20120201 ANDA ANDA091416 Dispensing Solutions, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66336-817_373fcf1b-f3b5-4a6b-b4da-12e81fceb7fb 66336-817 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Dispensing Solutions, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66336-819_31703dcf-5f13-4729-8e4d-9ed581b4cfd9 66336-819 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Dispensing Solutions, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 66336-834_9b60cb0d-4259-49dc-8b29-0dcf504cf40f 66336-834 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077156 Dispensing Solutions, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 66336-843_9cf56195-c94a-4fb0-8ce7-813c55a0502f 66336-843 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Dispensing Solutions, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 66336-851_cbc61b79-5794-4e61-b33c-a11638848845 66336-851 HUMAN PRESCRIPTION DRUG CALCITRIOL CALCITRIOL CAPSULE ORAL 20090826 NDA AUTHORIZED GENERIC NDA018044 Dispensing Solutions, Inc. CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 66336-857_6a51f874-89d9-4437-a8a8-462bb3a08801 66336-857 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA200044 Dispensing Solutions, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 66336-871_bd7d3e87-d87b-456e-b23f-5ee3b45ad366 66336-871 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide TABLET ORAL 20110216 ANDA ANDA091528 Dispensing Solutions, Inc. HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 66336-878_1ceb01db-7890-43fa-b31c-1c73a56e7032 66336-878 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980520 ANDA ANDA075009 Dispensing Solutions, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66336-897_05293257-1c22-45f7-8c6a-204043bab144 66336-897 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET OCCLUSIVE DRESSING TECHNIQUE 20080312 ANDA ANDA077455 Dispensing Solutions, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 66336-902_6b11fa9e-c8a5-4497-b5c5-13945879cdbb 66336-902 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100715 ANDA ANDA090931 Dispensing Solutions, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 66336-907_553f273b-5017-4e27-bf7c-7828a5f74c54 66336-907 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20090817 ANDA ANDA040833 Dispensing Solutions, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 66336-911_43b8794f-1137-4f23-be99-f2c7c3a63444 66336-911 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 Dispensing Solutions, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 66336-915_54c08b26-940a-468e-9b3d-9bda465caa48 66336-915 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 Dispensing Solutions, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 66336-916_3924e768-3967-4e22-9b2c-ac8bb80dcc27 66336-916 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Dispensing Solutions, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 66336-921_2c4f8e57-2745-43cd-a209-30d4c9ad58a7 66336-921 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine maleate TABLET ORAL 19980301 ANDA ANDA040268 Dispensing Solutions, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 66336-932_dfa9fa44-a29c-4f1f-9249-23ecd9e2efdf 66336-932 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20080925 ANDA ANDA078491 Dispensing Solutions, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 66336-940_d68cf56e-4789-449f-aab0-49d58b2e2f76 66336-940 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 19981002 NDA NDA020998 Dispensing Solutions, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66336-945_5819342b-4010-426a-96c2-cff5fdc5d1be 66336-945 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20100526 ANDA ANDA074424 Dispensing Solutions, Inc. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 66336-973_8194964b-a7fb-4f75-98b4-3a48f4f20a34 66336-973 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Dispensing Solutions, Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 66336-980_31703dcf-5f13-4729-8e4d-9ed581b4cfd9 66336-980 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Dispensing Solutions, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 66348-4105_4ad5dd24-c826-4975-8682-8080fec442ad 66348-4105 HUMAN OTC DRUG CRC Sunscreen Towel CRC Sunscreen Towel CLOTH TOPICAL 20100301 OTC MONOGRAPH FINAL part352 CRC Industries, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 40; 50 g/856mL; g/856mL; g/856mL; g/856mL 66353-100_b2f5820a-d726-4a8c-9d8c-fed4d4d697dc 66353-100 HUMAN OTC DRUG Harmon Face Values Advanced Severe Dry Skin Therapy Petrolatum OINTMENT TOPICAL 20111121 OTC MONOGRAPH FINAL part347 Delta Pharma Inc. PETROLATUM 41 g/100g 66353-200_6ea7d048-f495-45d9-b06f-e3f606f593ce 66353-200 HUMAN OTC DRUG Harmon Face Values Baby Healing Advanced Therapy Petrolatum OINTMENT TOPICAL 20120511 OTC MONOGRAPH FINAL part347 Delta Pharma Inc. PETROLATUM 41 g/100g 66357-180_7e869207-f60f-494b-a4c0-4e257f7afcdf 66357-180 HUMAN OTC DRUG DermaSav Zinc Oxide, Calamine CREAM TOPICAL 20130415 OTC MONOGRAPH FINAL part347 Biofilm, Inc FERRIC OXIDE RED; ZINC OXIDE 10; 180 mg/g; mg/g 66365-001_81afde70-94c4-4cd9-b44b-4753017e366e 66365-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20010601 UNAPPROVED MEDICAL GAS Medical Comfort Systems Inc OXYGEN 998 mL/L 66382-003_e93b9abc-099f-4dca-b66d-68400554f416 66382-003 HUMAN OTC DRUG Vichy Normaderm Pore Unclogging Daily Scrub Salicylic Acid GEL TOPICAL 20120201 OTC MONOGRAPH FINAL part333D Laboratoires Industriels de Vichy (LIDV) SALICYLIC ACID .625 mL/125mL 66382-004_ad15c8d0-3344-4bb0-8da1-e0843a895272 66382-004 HUMAN OTC DRUG Vichy Normaderm Purifying pore tightening toner Salicylic Acid LIQUID TOPICAL 20120201 OTC MONOGRAPH FINAL part333D Laboratoires Industriels de Vichy (LIDV) SALICYLIC ACID 1 mL/200mL 66382-005_b63eec47-7c3d-4252-94dc-330938ab150f 66382-005 HUMAN OTC DRUG Vichy Normaderm Daily deep cleansing Salicylic Acid GEL TOPICAL 20120201 OTC MONOGRAPH FINAL part333D Laboratoires Industriels de Vichy (LIDV) SALICYLIC ACID 1 mL/200mL 66382-157_7f87a97d-0418-4156-97ad-50d29387d851 66382-157 HUMAN OTC DRUG La Roche-Posay Laboratoire Pharmacetique HydraPhase UV Eyes Hydrating Protective Cream SPF 29 Octinoxate Titanium dioxide LOTION TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 Laboratoires Industriels de Vichy (LIDV) OCTINOXATE; TITANIUM DIOXIDE 1.125; 1.14 mL/15mL; mL/15mL 66382-222_874dcec4-35d9-4f60-a2e2-92205f688f12 66382-222 HUMAN OTC DRUG La Roche-Posay Laboratoire Dermatologique Anthelios 45 Ultra Light Sunscreen Fluid SPF 45 Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 Laboratoires Industriels de Vichy (LIDV) AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 5; 2.5; 2.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL 66382-223_d8778a68-b76b-4bfb-801b-961b67f17b20 66382-223 HUMAN OTC DRUG La RochePosay Laboratoire Dermatologique Effaclar K Salicylic Acid Acne Treatment Salicylic acid LOTION TOPICAL 20110701 OTC MONOGRAPH FINAL part333D Laboratoires Industriels de Vichy (LIDV) SALICYLIC ACID .45 mL/30mL 66382-229_9c21388f-4943-43ee-9940-04951a301c98 66382-229 HUMAN OTC DRUG Vichy Laboratoires Normaderm Triple Action Anti Acne Hydrating Salicylic Acid LOTION TOPICAL 20110301 OTC MONOGRAPH FINAL part333D Laboratoires Industriels de Vichy (LIDV) SALICYLIC ACID .5 mL/50mL 66382-254_e32f9500-dd8e-4ba4-a2ed-102682f549b3 66382-254 HUMAN OTC DRUG Vichy Laboratoires LiftActiv Retinol HA Total Anti-Wrinkle Daily Intervention SPF 18 Avobenzone Octisalate Octocrylene LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 Laboratoires Industriels de Vichy (LIDV) AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.2; 2; 2.8 mL/40mL; mL/40mL; mL/40mL 66382-299_9f47cf4b-da23-4516-95ab-efe193239312 66382-299 HUMAN OTC DRUG La Roche-Posay Laboratoire Dermatologique Anthelios 60 Ultra Light Sunscreen Fluid Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Laboratoires Industriels de Vichy (LIDV) AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 7.5; 2.5; 2.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL 66382-446_393aaeea-bbc8-4ceb-91cd-e441b856876f 66382-446 HUMAN OTC DRUG Vichy Laboratoires Normaderm Pro Mat Ultra Mattifying Oil-Free Lotion SPF 15 Ensulizole Octinoxate LOTION TOPICAL 20090727 OTC MONOGRAPH NOT FINAL part352 Laboratoires Industriels de Vichy (LIDV) ENSULIZOLE; OCTINOXATE .54; 2.25 mL/30mL; mL/30mL 66382-515_4b3e16a9-c70d-43ca-862f-0dc1085bbb0b 66382-515 HUMAN OTC DRUG Vichy Laboratoires Aqualia Antiox Pro-Youth Anti-Oxidant 24Hr Hydrating Fluid SPF 12 Avobenzone Octisalate Octocrylene LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 Laboratoires Industriels de Vichy (LIDV) AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.2; 2; 2 mL/40mL; mL/40mL; mL/40mL 66382-542_7b3894e8-6a3e-4d87-917a-8b25b89b4fc0 66382-542 HUMAN OTC DRUG La Roche-Posay Laboratoire Pharmaceutique Rosaliac UV Fortifying Anti-Redness Moisturizer SPF 15 Avobenzone Octisalate Octocrylene LOTION TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 Laboratoires Industriels de Vichy (LIDV) AVOBENZONE; OCTISALATE; OCTOCRYLENE .8; 1.32; 1.848 mL/40mL; mL/40mL; mL/40mL 66389-0001_10925f51-ce53-40db-a180-e5ec4e736268 66389-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20010417 UNAPPROVED MEDICAL GAS Griffin Home Health Care, Inc. OXYGEN 99 L/100L 66390-0001_a7ad812d-6aaf-44b2-a6a9-e106d44f05d3 66390-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000915 UNAPPROVED MEDICAL GAS Cache Valley Oxygen OXYGEN 99 L/100L 66391-0046_0d2db50d-5660-4d9d-af2a-f2ec0a2cc900 66391-0046 HUMAN OTC DRUG Miracle of Aloe Rub Roll On Menthol LIQUID TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part348 Winning Solutions MENTHOL 1.8 mL/90mL 66391-0301_5b156439-edab-40ec-bdfa-d46de0fc9534 66391-0301 HUMAN OTC DRUG Miracle Foot Repair Cream Menthol CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part348 Winning Solutions MENTHOL .224 g/224g 66391-0303_fcd72628-595e-4318-830e-e9ff88be7663 66391-0303 HUMAN OTC DRUG Miracle Rash Repair Salicylic Acid CREAM TOPICAL 20051128 OTC MONOGRAPH FINAL part358H Winning Solutions SALICYLIC ACID 2.016 g/112g 66391-0504_42072e37-eb03-4d14-a0c8-b80adb46832f 66391-0504 HUMAN OTC DRUG Miracle Foot Repair Menthol CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part348 Winning Solutions MENTHOL .028 g/28g 66391-0603_ea76436a-7eff-4d45-afdc-448b7399fc17 66391-0603 HUMAN OTC DRUG Miracle Rub Menthol, Methyl Salicylate CREAM TOPICAL 20050201 OTC MONOGRAPH NOT FINAL part348 Winning Solutions MENTHOL; METHYL SALICYLATE 2.475; 9.9 g/99g; g/99g 66391-0604_d68f0880-cec3-48aa-abc9-cbd9712b2448 66391-0604 HUMAN OTC DRUG Miracle Heel Repair Allantoin , Dimethicone CREAM TOPICAL 20090316 OTC MONOGRAPH NOT FINAL part347 Winning Solutions ALLANTOIN; DIMETHICONE 1.12; 1.12 g/112g; g/112g 66391-0610_611b0f79-aba0-4489-8306-c823e383d308 66391-0610 HUMAN OTC DRUG Miracle Foot Repair Menthol CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part348 Winning Solutions MENTHOL .224 g/224g 66403-308_2adf540d-c417-4f6f-bb20-4cb81535c7b6 66403-308 HUMAN OTC DRUG Tiger Balm Red Extra Strength Camphor (Synthetic) and Menthol OINTMENT TOPICAL 20020125 OTC MONOGRAPH NOT FINAL part348 Tiger Balm (Malaysia) Sdn. Bhd. CAMPHOR (SYNTHETIC); MENTHOL 110; 100 mg/g; mg/g 66403-309_f1c4249a-f220-4da9-b208-5220c4b8d6e3 66403-309 HUMAN OTC DRUG Tiger Balm White Regular Strength Camphor (Synthetic) and Menthol OINTMENT TOPICAL 20020125 OTC MONOGRAPH NOT FINAL part348 Tiger Balm (Malaysia) Sdn. Bhd. CAMPHOR (SYNTHETIC); MENTHOL 110; 80 mg/g; mg/g 66403-315_a09409ab-9c28-4745-b93f-4ff27e7de143 66403-315 HUMAN OTC DRUG Tiger Balm Ultra Strength Camphor (Synthetic) and Menthol OINTMENT TOPICAL 20020125 OTC MONOGRAPH NOT FINAL part348 Tiger Balm (Malaysia) Sdn. Bhd. CAMPHOR (SYNTHETIC); MENTHOL 110; 110 mg/g; mg/g 66414-001_d69759ab-92bb-4abb-807b-b1a099c6e7a1 66414-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20031001 UNAPPROVED MEDICAL GAS Garland Welding Supply Company OXYGEN 992 mL/L 66424-020_db28ac66-6fe4-4c73-8caa-b0e53c9a3006 66424-020 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20100127 OTC MONOGRAPH FINAL part341 SDA Laboratories, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 66424-021_64e6c69b-2376-4107-bf8a-7264917b877e 66424-021 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20100127 OTC MONOGRAPH FINAL part341 SDA Laboratories, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 66424-030_c7bb68e7-5479-467d-9fc0-fdf5a459486a 66424-030 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20100915 OTC MONOGRAPH NOT FINAL part334 SDA Laboratories, Inc. DOCUSATE SODIUM 100 mg/1 66424-034_bfa490bf-965b-4d6d-94fe-5aef98ab6b09 66424-034 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET ORAL 20100519 OTC MONOGRAPH FINAL part341 SDA Laboratories, Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 66424-045_e00c89cf-22f2-4da7-b3d6-32962dc1de39 66424-045 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate TABLET, CHEWABLE ORAL 20120927 OTC MONOGRAPH FINAL part335 SDA Laboratories, Inc. BISMUTH SUBSALICYLATE 262 mg/1 66424-520_3373f193-9c52-4b7c-b00f-67cda7bd311f 66424-520 HUMAN PRESCRIPTION DRUG Antipyrine and Benzocaine Antipyrine and Benzocaine SOLUTION AURICULAR (OTIC) 20000101 UNAPPROVED DRUG OTHER SDA Laboratories ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 66424-996_47cf8f81-1101-49bf-8e43-ed7761f1d1dd 66424-996 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110127 ANDA ANDA075661 SDA Laboratories, Inc. IBUPROFEN 200 mg/1 66428-002_a9bbadd5-6e2d-4221-b508-a9719779b3ce 66428-002 HUMAN OTC DRUG TheradermSPF 43 SPF 43 Zinc Oxide, Octinoxate, Octisalate EMULSION TOPICAL 20120120 OTC MONOGRAPH FINAL part352 Therapon Skin Health, LP OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 2.5; 7.5 mL/100mL; mL/100mL; mL/100mL 66428-003_e4a89a61-d8f4-4549-94bf-b9d5f6aa8e41 66428-003 HUMAN OTC DRUG Reversion Acne Control Clarifying Cleanser salicylic acid LIQUID TOPICAL 20120907 OTC MONOGRAPH FINAL part333D Therapon Skin Health, LP SALICYLIC ACID 1 mL/100mL 66428-004_a33debd0-2772-467c-9561-3ef9a32d6176 66428-004 HUMAN OTC DRUG Reversion Acne Control Clarifying Cleanser Face And Body salicylic acid LIQUID TOPICAL 20120907 OTC MONOGRAPH FINAL part333D Therapon Skin Health, LP SALICYLIC ACID 1 mL/100mL 66428-005_a1444fb7-62a5-4890-ad5a-65f3cf161fa0 66428-005 HUMAN OTC DRUG Reversion Acne Control Purifying Toner salicylic acid LIQUID TOPICAL 20120907 OTC MONOGRAPH FINAL part333D Therapon Skin Health, LP SALICYLIC ACID 2 mL/100mL 66428-006_b872ae97-15c0-4dfa-b63b-b79714602d3b 66428-006 HUMAN OTC DRUG Reversion Acne Control Spot Treatment PM benzoyl peroxide LIQUID TOPICAL 20120907 OTC MONOGRAPH FINAL part333D Therapon Skin Health, LP BENZOYL PEROXIDE 7.5 mL/100mL 66435-101_e579d82c-af3c-4331-aeba-0882a5ae9758 66435-101 HUMAN PRESCRIPTION DRUG Ribasphere Ribavirin CAPSULE ORAL 20040407 ANDA ANDA076203 Kadmon Pharmaceuticals, LLC RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 66435-102_783cb5f5-2429-4a7a-a531-64d8a4ed9d15 66435-102 HUMAN PRESCRIPTION DRUG RIBASPHERE ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077456 Kadmon Pharmaceuticals, LLC RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 66435-103_783cb5f5-2429-4a7a-a531-64d8a4ed9d15 66435-103 HUMAN PRESCRIPTION DRUG RIBASPHERE ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077456 Kadmon Pharmaceuticals, LLC RIBAVIRIN 400 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 66435-104_783cb5f5-2429-4a7a-a531-64d8a4ed9d15 66435-104 HUMAN PRESCRIPTION DRUG RIBASPHERE ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077456 Kadmon Pharmaceuticals, LLC RIBAVIRIN 600 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 66435-105_783cb5f5-2429-4a7a-a531-64d8a4ed9d15 66435-105 HUMAN PRESCRIPTION DRUG RIBASPHERE RibaPak ribavirin TABLET ORAL 20100101 ANDA ANDA077456 Kadmon Pharmaceuticals, LLC RIBAVIRIN 400 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 66435-106_783cb5f5-2429-4a7a-a531-64d8a4ed9d15 66435-106 HUMAN PRESCRIPTION DRUG RIBASPHERE RibaPak ribavirin KIT 20100101 ANDA ANDA077456 Kadmon Pharmaceuticals, LLC 66435-107_783cb5f5-2429-4a7a-a531-64d8a4ed9d15 66435-107 HUMAN PRESCRIPTION DRUG RIBASPHERE RibaPak ribavirin TABLET ORAL 20100101 ANDA ANDA077456 Kadmon Pharmaceuticals, LLC RIBAVIRIN 600 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 66435-108_783cb5f5-2429-4a7a-a531-64d8a4ed9d15 66435-108 HUMAN PRESCRIPTION DRUG RIBASPHERE RibaPak ribavirin KIT 20120601 ANDA ANDA077456 Kadmon Pharmaceuticals, LLC 66435-301_80ecf7b9-2cb2-4059-aa37-873e32ff028d 66435-301 HUMAN PRESCRIPTION DRUG AMPHOTEC Amphotericin B INJECTION, LIPID COMPLEX INTRAVENOUS 20050520 NDA NDA050729 Kadmon Pharmaceuticals LLC AMPHOTERICIN B 50 mg/50mg Lipid-based Polyene Antifungal [EPC],Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 66435-302_80ecf7b9-2cb2-4059-aa37-873e32ff028d 66435-302 HUMAN PRESCRIPTION DRUG AMPHOTEC Amphotericin B INJECTION, LIPID COMPLEX INTRAVENOUS 20050520 NDA NDA050729 Kadmon Pharmaceuticals LLC AMPHOTERICIN B 100 mg/100mg Lipid-based Polyene Antifungal [EPC],Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 66435-410_715620fb-614f-40b6-8d3d-8494843d8518 66435-410 HUMAN PRESCRIPTION DRUG Topotecan Hydrochloride topotecan hydrochloride INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20101202 ANDA ANDA091199 Three Rivers Pharmaceuticals, LLC. TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 66435-415_37ab9c22-1f7c-4a54-a143-753b353d96a4 66435-415 HUMAN PRESCRIPTION DRUG Anastrozole anastrozole TABLET, FILM COATED ORAL 20100628 ANDA ANDA091164 Kadmon Pharmaceuticals, LLC ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 66449-003_fd81c32e-24ab-40ba-a430-94f3464001c1 66449-003 HUMAN OTC DRUG Germicida Antimicrobial Triclosan SOAP TOPICAL 20120630 OTC MONOGRAPH NOT FINAL part333A Laboratorios Roldan, S.A. TRICLOSAN 1 g/100g 66449-004_44912ec3-e2bc-4e51-a911-37639196b8bc 66449-004 HUMAN OTC DRUG Germicida Antimicrobial Triclosan SOAP TOPICAL 20120630 OTC MONOGRAPH NOT FINAL part333A Laboratorios Roldan, S.A. TRICLOSAN 2 g/100g 66467-1081_c372c3f2-18ea-4b55-a883-cb89bb39f4fa 66467-1081 HUMAN PRESCRIPTION DRUG SuperDent Hemal Aluminum Chloride SOLUTION DENTAL 19630219 UNAPPROVED DRUG OTHER Darby Dental Supply LLC ALUMINUM CHLORIDE 250 mg/g 66467-2000_2a7410b2-86cb-437d-bdba-4276a22659f0 66467-2000 HUMAN PRESCRIPTION DRUG Superdent Raspberry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Darby Dental Supply LLC BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 66467-2001_2a7410b2-86cb-437d-bdba-4276a22659f0 66467-2001 HUMAN PRESCRIPTION DRUG Superdent Bubble Gum Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Darby Dental Supply LLC BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 66467-2002_2a7410b2-86cb-437d-bdba-4276a22659f0 66467-2002 HUMAN PRESCRIPTION DRUG Superdent Cherry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Darby Dental Supply LLC BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 66467-2003_2a7410b2-86cb-437d-bdba-4276a22659f0 66467-2003 HUMAN PRESCRIPTION DRUG Superdent Mint Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Darby Dental Supply LLC BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 66467-2004_2a7410b2-86cb-437d-bdba-4276a22659f0 66467-2004 HUMAN PRESCRIPTION DRUG Superdent Pina Colada Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Darby Dental Supply LLC BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 66467-2005_2a7410b2-86cb-437d-bdba-4276a22659f0 66467-2005 HUMAN PRESCRIPTION DRUG Superdent Banana Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Darby Dental Supply LLC BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 66467-2006_2a7410b2-86cb-437d-bdba-4276a22659f0 66467-2006 HUMAN PRESCRIPTION DRUG Superdent Strawberry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Darby Dental Supply LLC BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 66467-2120_7acdfd7c-cdb2-4602-9e1a-6a95c24dba11 66467-2120 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Sodium Fluoride GEL DENTAL 20101217 UNAPPROVED DRUG OTHER Darby Dental Supply Co Inc SODIUM FLUORIDE .0272 g/mL 66467-2130_80bb2368-6c3b-41bf-b689-9028775de1c0 66467-2130 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Sodium Fluoride GEL DENTAL 20101109 UNAPPROVED DRUG OTHER Darby Dental Supply Co Inc SODIUM FLUORIDE .0272 g/mL 66467-2140_84c72812-9e25-4e6b-987a-b29a4bb9c1df 66467-2140 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Sodium Fluoride GEL DENTAL 20101112 UNAPPROVED DRUG OTHER Darby Dental Supply Co Inc SODIUM FLUORIDE .0272 g/mL 66467-2150_e47ed005-49f0-4f20-b49f-2fcb58732054 66467-2150 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Sodium Fluoride GEL DENTAL 20101112 UNAPPROVED DRUG OTHER Darby Dental Supply Co Inc SODIUM FLUORIDE .0272 g/mL 66467-2160_0e43649a-d3be-49e0-812e-ab066b5428a3 66467-2160 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Sodium Fluoride GEL DENTAL 20101118 UNAPPROVED DRUG OTHER Darby Dental Supply Co Inc SODIUM FLUORIDE .0272 g/mL 66467-2170_c0b04311-5658-4bcf-99c2-930795ab3e48 66467-2170 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Sodium Fluoride GEL DENTAL 20101112 UNAPPROVED DRUG OTHER Darby Dental Supply Co Inc SODIUM FLUORIDE .0272 g/mL 66467-2190_ea7b0f4b-6633-4805-a88d-4e68b6242f7b 66467-2190 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Sodium Fluoride GEL DENTAL 20101112 UNAPPROVED DRUG OTHER Darby Dental Supply Co Inc SODIUM FLUORIDE .0272 g/mL 66467-2560_73f7bbf5-93bb-4705-8075-93a4ad5c6a3d 66467-2560 HUMAN PRESCRIPTION DRUG Superdent Chlorhexidine Gluconate Oral Rinse Chlorhexidine Gluconate LIQUID DENTAL 20060702 ANDA ANDA077789 Darby Dental Supply, LLC CHLORHEXIDINE GLUCONATE .12 g/100mL Decreased Cell Wall Integrity [PE] 66467-3720_c8224ef4-d66c-416c-a96c-fc5dc7fc38b2 66467-3720 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Watermelon Sodium Fluoride AEROSOL, FOAM DENTAL 20120131 UNAPPROVED DRUG OTHER Darby Dental Supply Co SODIUM FLUORIDE .0272 g/g 66467-3730_7fcb5aa9-bd10-42a0-beb4-49a3f8ff332b 66467-3730 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Bubble Gum Sodium Fluoride AEROSOL, FOAM DENTAL 20120131 UNAPPROVED DRUG OTHER Darby Dental Supply Co SODIUM FLUORIDE .0272 g/g 66467-3740_5da0455a-3e76-4d9e-ac7a-20d38313c51f 66467-3740 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Cherry Sodium Fluoride AEROSOL, FOAM DENTAL 20120131 UNAPPROVED DRUG OTHER Darby Dental Supply Co SODIUM FLUORIDE .0272 g/g 66467-3750_81e3f20a-202c-44c1-82ce-e9a63357f458 66467-3750 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Grape Sodium Fluoride AEROSOL, FOAM DENTAL 20120131 UNAPPROVED DRUG OTHER Darby Dental Supply Co SODIUM FLUORIDE .0272 g/g 66467-3760_17633c15-5c8a-472b-a5a6-439edf233f6b 66467-3760 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Mint Sodium Fluoride AEROSOL, FOAM DENTAL 20120131 UNAPPROVED DRUG OTHER Darby Dental Supply Co SODIUM FLUORIDE .0272 g/g 66467-3770_9b533173-ef9a-4e25-8a4a-dca65362a737 66467-3770 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Orange Sodium Fluoride AEROSOL, FOAM DENTAL 20120131 UNAPPROVED DRUG OTHER Darby Dental Supply Co SODIUM FLUORIDE .0272 g/g 66467-3790_39b3eeeb-5308-4b8f-9771-5b37ae47a23d 66467-3790 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Strawberry Sodium Fluoride AEROSOL, FOAM DENTAL 20120131 UNAPPROVED DRUG OTHER Darby Dental Supply Co SODIUM FLUORIDE .0272 g/g 66467-9710_216bd2e3-0d78-4819-be50-bbdbbabe3bb7 66467-9710 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20110114 ANDA ANDA088389 Darby Dental Supply, LLC EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .02; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 66467-9730_bfbde814-d94e-47f9-973b-a3b4f0a9affb 66467-9730 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20110114 ANDA ANDA088390 Darby Dental Supply, LLC EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 66467-9760_36147b88-e551-46af-b3e7-f3e3f02ffcfd 66467-9760 HUMAN PRESCRIPTION DRUG Mepivacaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20110114 ANDA ANDA088387 Darby Dental Supply, LLC MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 66467-9790_1d8eb60e-8232-411f-b214-5a8f7fa3a467 66467-9790 HUMAN PRESCRIPTION DRUG Mepivacaine Hydrochloride and Levonordefrin Mepivacaine Hydrochloride and Levonordefrin INJECTION, SOLUTION SUBCUTANEOUS 20110114 ANDA ANDA088388 Darby Dental Supply, LLC LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE .05; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 66472-023_0b5bca77-7810-4560-922d-09e51a60a87b 66472-023 HUMAN OTC DRUG Benefit Triple Performing Facial Emulsion Broad Spectrum SPF 15 AVOBENZONE, OCTOCRYLENE, OCTINOXATE, SULISOBENZONE EMULSION TOPICAL 20110728 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE; SULISOBENZONE 30; 74.9; 20; 15 mg/mL; mg/mL; mg/mL; mg/mL 66472-024_fafec8e0-92b0-4934-a95f-004040452442 66472-024 HUMAN OTC DRUG HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - Im So Glamber OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 66472-025_2aa26fb5-9dbf-40f8-ad7d-f9964a910ab2 66472-025 HUMAN OTC DRUG HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - Im All The Rage OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 66472-026_b38716fa-bc12-4834-a05e-fda3e6bed7ab 66472-026 HUMAN OTC DRUG HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - CHEERS TO ME OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 66472-027_e7ddebed-3b7c-434e-b579-c54c06c8ffee 66472-027 HUMAN OTC DRUG HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - Im Hopelessly Hot OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 66472-028_8d81bf67-0cf6-44fb-982b-d7163adc7e7d 66472-028 HUMAN OTC DRUG HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - IM SO MONEY OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 66472-029_0b0ea9e1-1ae8-4804-9a06-a0c6b5c1489d 66472-029 HUMAN OTC DRUG HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - BELIEVE IN ME OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 66472-030_050540cd-5fc8-40c4-8ee8-216116f1e8c9 66472-030 HUMAN OTC DRUG HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - IM PURE 4 SURE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 66472-031_4beb4e93-06fb-4cd9-8209-0855798d0b69 66472-031 HUMAN OTC DRUG HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - GOTTA KNOW ME OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 66472-032_72947b6c-9947-4882-ad4a-9e897a4f6ebd 66472-032 HUMAN OTC DRUG HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - IM PLUSH AND PRECIOUS OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 66472-033_2a182f48-a429-426a-8e22-3f10dc75561f 66472-033 HUMAN OTC DRUG HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - WARM ME UP OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL 66472-034_570f7ec6-b5f4-4610-86aa-2a0b57940a66 66472-034 HUMAN OTC DRUG Benefit BOO BOO ZAP Medicated Acne Treatment SALICYLIC ACID CREAM TOPICAL 20111229 OTC MONOGRAPH FINAL part333D Benefit Cosmetics, LLC SALICYLIC ACID .5 mL/100mL 66472-035_8c629dbb-f3b3-4c36-87a1-a6a391d42e41 66472-035 HUMAN OTC DRUG benefit BIG EASY BROAD SPECTRUM SPF 35 SUNSCREEN multi-balancing complexion perfector - 01 FAIR OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20131113 OTC MONOGRAPH NOT FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 50; 47 mg/mL; mg/mL; mg/mL 66472-036_3aa1fe4f-1ec2-4763-ab7e-e79aae391fe9 66472-036 HUMAN OTC DRUG benefit BIG EASY BROAD SPECTRUM SPF 35 SUNSCREEN multi-balancing complexion perfector - 02 LIGHT OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20131112 OTC MONOGRAPH NOT FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 50; 47 mg/mL; mg/mL; mg/mL 66472-037_3c4a1ae4-2617-4524-b254-2d8c5d7409d1 66472-037 HUMAN OTC DRUG benefit BIG EASY BROAD SPECTRUM SPF 35 SUNSCREEN multi-balancing complexion perfector - 03 LIGHTMEDIUM OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20131113 OTC MONOGRAPH NOT FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 50; 47 mg/mL; mg/mL; mg/mL 66472-038_82724908-5b42-4a41-ade7-8cce6379a9fd 66472-038 HUMAN OTC DRUG benefit BIG EASY BROAD SPECTRUM SPF 35 SUNSCREEN multi-balancing complexion perfector - 04 MEDIUM OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20131113 OTC MONOGRAPH NOT FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 50; 47 mg/mL; mg/mL; mg/mL 66472-039_fbf55cac-a106-4c08-a0de-2568c01a8b23 66472-039 HUMAN OTC DRUG benefit BIG EASY BROAD SPECTRUM SPF 35 SUNSCREEN multi-balancing complexion perfector - 05 BEIGE OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20131113 OTC MONOGRAPH NOT FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 50; 47 mg/mL; mg/mL; mg/mL 66472-040_4be8c7bb-11d1-488e-8a38-77b045923ad5 66472-040 HUMAN OTC DRUG benefit BIG EASY BROAD SPECTRUM SPF 35 SUNSCREEN multi-balancing complexion perfector - 06 DEEP BEIGE OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20131113 OTC MONOGRAPH NOT FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 50; 47 mg/mL; mg/mL; mg/mL 66472-041_55c11913-2906-4a7c-bdd1-e65b89bb2e3f 66472-041 HUMAN OTC DRUG benefit DREAM SCREEN BROAD SPECTRUM SPF 45 SUNSCREEN FOR FACE AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20131112 OTC MONOGRAPH NOT FINAL part352 Benefit Cosmetics, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL 66479-582_e0403b6a-bb39-4f86-b1fc-0669127deed2 66479-582 HUMAN PRESCRIPTION DRUG Roxicodone oxycodone hydrochloride TABLET ORAL 20000831 20150731 NDA NDA021011 Xanodyne Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 66479-592_22f8d64e-e73d-4cd7-8ec2-9597da573e20 66479-592 HUMAN PRESCRIPTION DRUG Zipsor diclofenac potassium CAPSULE, LIQUID FILLED ORAL 20100430 20150228 NDA NDA022202 Xanodyne Pharmaceuticals, Inc. DICLOFENAC POTASSIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66487-001_fe50ec36-7d03-4b3d-bfbd-7003d22edb69 66487-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990109 NDA NDA205840 ROBINSON`S INDUSTRIAL GAS & EQUIPMENT CORP. OXYGEN 997 mL/L 66487-002_6b5be74c-a69f-4f81-b699-fe16f3594283 66487-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen LIQUID RESPIRATORY (INHALATION) 20100901 NDA NDA205839 ROBINSON`S INDUSTRIAL GAS & EQUIPMENT CORP. NITROGEN 997 mL/L 66490-041_d896558b-f3fe-4663-bac8-730c379767ce 66490-041 HUMAN PRESCRIPTION DRUG D.H.E. 45 Dihydroergotamine Mesylate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20011003 NDA NDA005929 Valeant Pharmaceuticals North America DIHYDROERGOTAMINE MESYLATE 1 mg/mL Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient] 66490-650_94accc84-3469-4a64-9bf7-e050d75c3804 66490-650 HUMAN PRESCRIPTION DRUG Diastat diazepam GEL RECTAL 19970729 NDA NDA020648 Valeant Pharmaceuticals North America LLC DIAZEPAM 2.5 mg/.5mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 66490-690_8e3319b6-61dd-4243-a9cf-b5acc34358ad 66490-690 HUMAN PRESCRIPTION DRUG Mysoline Primidone TABLET ORAL 20090624 NDA NDA009170 Valeant Pharmaceuticals North America PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 66490-691_8e3319b6-61dd-4243-a9cf-b5acc34358ad 66490-691 HUMAN PRESCRIPTION DRUG Mysoline Primidone TABLET ORAL 20090624 NDA NDA009170 Valeant Pharmaceuticals North America PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 66497-0001_d5b80023-ce5c-472c-bc7b-63aad334c839 66497-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020613 UNAPPROVED MEDICAL GAS Boll Medical Inc. OXYGEN 99 L/100L 66506-181_d3ea5494-00a7-4fa1-a469-eed5a06e5d01 66506-181 HUMAN OTC DRUG Cheezheng Pain Relieving Camphor (Natural) PATCH TOPICAL 20130120 OTC MONOGRAPH FINAL part348 Tibet Cheezheng Tibetan Medicine Co. Ltd. CAMPHOR (NATURAL) 13.875 mg/h 66513-220_08d58a1a-c769-4209-b83d-2c792a991d96 66513-220 HUMAN OTC DRUG Bronco Rub Camphor Eucalyptus Menthol OINTMENT TOPICAL 20140815 OTC MONOGRAPH FINAL part341 Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 g/100g; g/100g; g/100g 66513-222_4d1e7e82-c8e8-4d94-915c-26b3616b5335 66513-222 HUMAN OTC DRUG Broncolin Camphor Menthol OINTMENT TOPICAL 20110615 OTC MONOGRAPH FINAL part341 Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V. CAMPHOR (NATURAL); MENTHOL 5.3; 2.8 g/100g; g/100g 66521-112_51abe0e0-adb8-11de-85ae-0002a5d5c51b 66521-112 VACCINE Fluvirin Influenza Virus Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 19980812 BLA BLA103837 Novartis Vaccines and Diagnostics Ltd INFLUENZA A VIRUS A/BRISBANE/59/2007(H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/URUGUAY/716/2007(H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL Inactivated Influenza A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient],Inactivated Influenza B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient] 66521-113_02286c32-5387-4591-a1db-aed0e9466bd1 66521-113 VACCINE FLUVIRIN INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/VICTORIA/210/2009 X-187 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATE INJECTION, SUSPENSION INTRAMUSCULAR 19880812 BLA BLA103837 Novartis Vaccines and Diagnostics Limited INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/210/2009 X-187 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL Inactivated Influenza A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient],Inactivated Influenza B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient] 66521-114_962ce54b-4ace-430d-80e5-5e7a8c03c723 66521-114 VACCINE FLUVIRIN INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/VICTORIA/210/2009 X-187 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20110701 BLA BLA103837 Novartis Vaccines and Diagnostics Limited INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/210/2009 X-187 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL Inactivated Influenza B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient] 66521-115_3d88e51e-06cd-4ae3-b45e-7f24e39c308c 66521-115 VACCINE FLUVIRIN INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20120720 BLA BLA103837 Novartis Vaccines and Diagnostics Limited INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL 66521-200_04366dc0-ba66-11de-a487-0002a5d5c51b 66521-200 VACCINE Influenza A (H1N1) 2009 Monovalent Vaccine Influenza A (H1N1) 2009 Monovalent Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20090915 BLA BLA103837 Novartis Vaccines and Diagnostics Ltd INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug/.5mL 66530-249_6efaa46c-309a-48c6-b62c-414de9e05fa6 66530-249 HUMAN PRESCRIPTION DRUG FLUOROURACIL fluorouracil CREAM TOPICAL 20080411 ANDA ANDA077524 Spear Dermatology Products FLUOROURACIL 50 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 66530-250_4ba85926-5af5-4a5f-9542-aab4d12be688 66530-250 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20130731 ANDA ANDA202026 Spear Dermatology Products TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 66530-251_4ba85926-5af5-4a5f-9542-aab4d12be688 66530-251 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20130731 ANDA ANDA202567 Spear Dermatology Products TRETINOIN .04 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 66530-253_fc1e1da6-06a8-4578-9d09-5a33be194501 66530-253 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20140206 NDA AUTHORIZED GENERIC NDA019049 Spear Dermatology Products Inc TRETINOIN .025 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 66530-254_fc1e1da6-06a8-4578-9d09-5a33be194501 66530-254 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20140206 NDA AUTHORIZED GENERIC NDA017522 Spear Dermatology Products Inc TRETINOIN .05 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 66530-255_fc1e1da6-06a8-4578-9d09-5a33be194501 66530-255 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20140206 NDA AUTHORIZED GENERIC NDA017340 Spear Dermatology Products Inc TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 66530-256_fc1e1da6-06a8-4578-9d09-5a33be194501 66530-256 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20140206 NDA AUTHORIZED GENERIC NDA017955 Spear Dermatology Products Inc TRETINOIN .01 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 66530-257_fc1e1da6-06a8-4578-9d09-5a33be194501 66530-257 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20140206 NDA AUTHORIZED GENERIC NDA017579 Spear Dermatology Products Inc TRETINOIN .025 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 66530-258_41b7c43d-1935-4d3a-83f0-ee5b02b8ba83 66530-258 HUMAN PRESCRIPTION DRUG Fluorouracil fluorouracil CREAM TOPICAL 20141028 NDA AUTHORIZED GENERIC NDA020985 Spear Dermatology Products Inc FLUOROURACIL 5 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 66530-259_4aaccfbc-9391-4e3f-b25f-7e55406195ad 66530-259 HUMAN PRESCRIPTION DRUG Tretinoin Gel Microsphere Tretinoin GEL TOPICAL 20141001 NDA AUTHORIZED GENERIC NDA020475 Spear Dermatology Products Inc TRETINOIN .04 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 66530-260_4aaccfbc-9391-4e3f-b25f-7e55406195ad 66530-260 HUMAN PRESCRIPTION DRUG Tretinoin Gel Microsphere Tretinoin GEL TOPICAL 20141001 NDA AUTHORIZED GENERIC NDA020475 Spear Dermatology Products Inc TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 66538-101_5f1ee376-412a-4978-ab8e-0480170b280a 66538-101 HUMAN OTC DRUG SUNSCREEN SPF 28 OCTINOXATE ZINC OXIDE CREAM TOPICAL 20111128 OTC MONOGRAPH NOT FINAL part352 COSMOCEUTICAL RESEARCH CENTER INC OCTINOXATE; ZINC OXIDE 7.5; 6 g/100g; g/100g 66538-201_70881c46-85f5-4a89-b5b4-5f97d53c8ce2 66538-201 HUMAN OTC DRUG LIGHTENER HYDROQUINONE CREAM TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part358A CRC (Cosmoceutical Research Center) HYDROQUINONE 1.9 g/100g 66538-301_4d4670cb-bb74-4963-adfc-9b2998d26ef4 66538-301 HUMAN PRESCRIPTION DRUG ANESTHETIC LIDOCAINE HYDROCHLORIDE BENZOCAINE GEL TOPICAL 20120218 OTC MONOGRAPH NOT FINAL part348 COSMOCEUTICAL RESEARCH CENTER INC LIDOCAINE HYDROCHLORIDE 5 g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 66538-401_1a3710a7-5f90-41d8-a2e3-fc0542849d83 66538-401 HUMAN OTC DRUG NUJEVI ACNE BENZOYL PEROXIDE CREAM TOPICAL 20140828 OTC MONOGRAPH FINAL part333D COSMOCEUTICAL RESEARCH CENTER INC BENZOYL PEROXIDE 2.5 g/100g 66538-501_2fed1af5-6095-49b7-ae99-8a9d8f8cc33f 66538-501 HUMAN PRESCRIPTION DRUG Trichloroacetic Acid 15% Trichloroacetic Acid LIQUID TOPICAL 20140924 UNAPPROVED DRUG OTHER CRC (Cosmoceutical Research Center) TRICHLOROACETIC ACID 15 g/100mL 66538-502_dd7e800e-23af-4f4d-b3a4-d582ae94891e 66538-502 HUMAN PRESCRIPTION DRUG Trichloroacetic Acid 30% Trichloroacetic Acid LIQUID TOPICAL 20140924 UNAPPROVED DRUG OTHER CRC (Cosmoceutical Research Center) TRICHLOROACETIC ACID 30 g/100mL 66538-503_16263082-c179-4375-93bd-acefa4181226 66538-503 HUMAN PRESCRIPTION DRUG Trichloroacetic Acid 50% Trichloroacetic Acid LIQUID TOPICAL 20140924 UNAPPROVED DRUG OTHER CRC (Cosmoceutical Research Center) TRICHLOROACETIC ACID 30 g/100mL 66552-0001_7ced7f77-b265-41c9-9a61-921172f46632 66552-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20010711 UNAPPROVED MEDICAL GAS Alpine Home Medical Equipment OXYGEN 99 L/100L 66559-1471_02028bea-3836-46d2-af7b-b5c7868985c9 66559-1471 HUMAN OTC DRUG Amazing Face Skin Balancing Flexible Coverage Foundation Octisalate and Octinoxate POWDER TOPICAL 20100517 OTC MONOGRAPH FINAL part352 Cosmetica Laboratories Inc. OCTINOXATE; OCTISALATE .45; .27 g/9g; g/9g 66559-1472_02028bea-3836-46d2-af7b-b5c7868985c9 66559-1472 HUMAN OTC DRUG Amazing Face Skin Balancing Flexible Coverage Foundation Octisalate and Octinoxate POWDER TOPICAL 20100517 OTC MONOGRAPH FINAL part352 Cosmetica Laboratories Inc. OCTINOXATE; OCTISALATE .45; .27 g/9g; g/9g 66559-1473_02028bea-3836-46d2-af7b-b5c7868985c9 66559-1473 HUMAN OTC DRUG Amazing Face Skin Balancing Flexible Coverage Foundation Octisalate and Octinoxate POWDER TOPICAL 20100517 OTC MONOGRAPH FINAL part352 Cosmetica Laboratories Inc. OCTINOXATE; OCTISALATE .45; .27 g/9g; g/9g 66559-1474_02028bea-3836-46d2-af7b-b5c7868985c9 66559-1474 HUMAN OTC DRUG Amazing Face Skin Balancing Flexible Coverage Foundation Octisalate and Octinoxate POWDER TOPICAL 20100517 OTC MONOGRAPH FINAL part352 Cosmetica Laboratories Inc. OCTINOXATE; OCTISALATE .45; .27 g/9g; g/9g 66559-1475_02028bea-3836-46d2-af7b-b5c7868985c9 66559-1475 HUMAN OTC DRUG Amazing Face Skin Balancing Flexible Coverage Foundation Octisalate and Octinoxate POWDER TOPICAL 20100517 OTC MONOGRAPH FINAL part352 Cosmetica Laboratories Inc. OCTINOXATE; OCTISALATE .45; .27 g/9g; g/9g 66559-2977_6dcdd70a-6b2f-477f-8f91-189a9c32089a 66559-2977 HUMAN OTC DRUG No7 CC LIGHT Octocrylene and Octinoxate EMULSION TOPICAL 20140501 OTC MONOGRAPH FINAL part352 Cosmetica Laboratories Inc. OCTINOXATE; OCTOCRYLENE 75; 80 mg/mL; mg/mL 66559-2978_6dcdd70a-6b2f-477f-8f91-189a9c32089a 66559-2978 HUMAN OTC DRUG No7 CC MEDIUM Octocrylene and Octinoxate EMULSION TOPICAL 20140501 OTC MONOGRAPH FINAL part352 Cosmetica Laboratories Inc. OCTINOXATE; OCTOCRYLENE 75; 80 mg/mL; mg/mL 66579-0008_4ff9b5d9-3430-4a92-8240-9d8e4aa64eb1 66579-0008 HUMAN OTC DRUG Tremor Plex Agaricus muscarius, Argentum nitricum, Aurum sulphuratum, Causticum, Gelsemium sempervirens, Heloderma, Hyoscyamus niger, Manganum aceticum, Mercurius solubilis, Stramonium, Zincum metallicum LIQUID ORAL 20140821 UNAPPROVED HOMEOPATHIC New Sun Inc. AMANITA MUSCARIA FRUITING BODY; CAUSTICUM; DATURA STRAMONIUM; GELSEMIUM SEMPERVIRENS ROOT; GOLD MONOSULFIDE; HELODERMA HORRIDUM VENOM; HYOSCYAMUS NIGER; MANGANESE ACETATE TETRAHYDRATE; MERCURIUS SOLUBILIS; SILVER NITRATE; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0009_90c87a4a-c448-4bcd-96d0-043842fe68b3 66579-0009 HUMAN OTC DRUG Sleep Eezzz Aconitum napellus, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Passiflora incarnata, Pulsatilla, Valeriana officinalis LIQUID ORAL 20140730 UNAPPROVED HOMEOPATHIC New Sun Inc. ACONITUM NAPELLUS; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; AVENA SATIVA FLOWERING TOP; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; CYPRIPEDIUM PARVIFOLUM ROOT; HYOSCYAMUS NIGER; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA VULGARIS; VALERIAN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0010_3563d170-e38f-4916-816d-304fe5b78073 66579-0010 HUMAN OTC DRUG Acne Clear Antimonium tartaricum, Asterias rubens, Ferrum metallicum, Hepar sulphuris calcareum, Kali bromatum, Natrum muriaticum, Sanguinaria canadensis, Selenium metallicum, Sepia, Silicea, Sulphur, thuja occidentalis LIQUID ORAL 20100721 UNAPPROVED HOMEOPATHIC New Sun Inc. ANTIMONY POTASSIUM TARTRATE; ASTERIAS RUBENS; CALCIUM SULFIDE; IRON; POTASSIUM BROMIDE; SANGUINARIA CANADENSIS ROOT; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CHLORIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0013_9a881380-886b-445a-941f-5938729aac41 66579-0013 HUMAN OTC DRUG Detox and Drainage, Blood and Kidney Arsenicum album, Baptisia tinctoria, Carbo vegetabilis, Chininum sulphuricum, Cinchona officinalis, Conium maculatum, Echinacea purpurea, Ferrum metallicum, Hydrastis canadensis, Kali chloricum, Mercurius corrosivus, Serum anguillae LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC New Sun Inc. ACTIVATED CHARCOAL; ANGUILLA ROSTRATA BLOOD SERUM; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; ECHINACEA PURPUREA; GOLDENSEAL; IRON; MERCURIC CHLORIDE; POTASSIUM CHLORATE; QUININE SULFATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0014_dc78cf98-45f0-4af6-af8c-51b890e32013 66579-0014 HUMAN OTC DRUG Detox and Drainage, Liver Arsenicum album, Baptisia tinctoria, Berberis vulgaris, Bryonia, Carduus marianus, Chelidonium majus, Chionanthus virginica, Cinchona officinalis, Lycopodium clavatum Manganum muriaticum, Natrum sulphuricum, Nux vomica, Phosphorus, Sulphur, Taraxacum officinale LIQUID ORAL 20140730 UNAPPROVED HOMEOPATHIC New Sun Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; MANGANESE CHLORIDE; MILK THISTLE; PHOSPHORUS; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SULFUR; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0018_edf85228-abd3-4f67-8a53-48fdc8678e26 66579-0018 HUMAN OTC DRUG Stress and Anxiety Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Cistus canadensis, Clematis erecta, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Impatiens glandulifera, flos, Ornithogalum umbellatum, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, Sulphur, Symphytum officinale, Veratrum album LIQUID ORAL 20140717 UNAPPROVED HOMEOPATHIC New Sun Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CLEMATIS RECTA FLOWERING TOP; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; MATRICARIA RECUTITA; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; STRYCHNOS IGNATII SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0019_5f89edcb-2acc-4c97-9117-1eef01c0eee9 66579-0019 HUMAN OTC DRUG Acute Viro Reliever Aconitum napellus, Belladonna, Chininum sulphuricum, Ferrum phosphoricum, Hepar sulphuris calcareum, Mercurius corrosivus, Natrum muriaticum, Nux vomica, Phosphorus, Pulsatilla, Sarcolacticum acidum, Sulphur LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC New Sun Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; CALCIUM SULFIDE; FERROSOFERRIC PHOSPHATE; LACTIC ACID, L-; MERCURIC CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; QUININE SULFATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0023_35127dbb-ea5f-43d6-8577-423e42ed883e 66579-0023 HUMAN OTC DRUG Bacterial Reliever Allium sativum, Arsenicum album, Baptisia tinctoria, Belladonna, Echinacea purpurea, Eucalyptus globulus, Hydrastis canadensis, Lac caninum, Myristica sebifera, Myrtus communis, Phosphorus, Phytolacca decandra LIQUID ORAL 20140917 UNAPPROVED HOMEOPATHIC New Sun Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; CANIS LUPUS FAMILIARIS MILK; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; GARLIC; GOLDENSEAL; MYRTUS COMMUNIS TOP; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; VIROLA SEBIFERA RESIN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0026_da840a58-8724-4b2c-b0f6-2d3c698fd793 66579-0026 HUMAN OTC DRUG Sinus Relief Apis mellifica, Baptisia tinctoria, Colocythis, Hepar sulphuris calcareum, Histaminum hydrochloricum, Hydrastis canadensis, Ignatia amara, Kali bichromicum, Lemna minor, Mercurius vivus, Pulsatilla, Rhus toxicodendron, Sabadilla, Thuja occidentalis LIQUID ORAL 20140717 UNAPPROVED HOMEOPATHIC New Sun Inc. APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; CITRULLUS COLOCYNTHIS FRUIT PULP; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; LEMNA MINOR; MERCURY; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; STRYCHNOS IGNATII SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0028_4662f6d8-2b3a-4f2d-8d1a-4662a3514eb6 66579-0028 HUMAN OTC DRUG Back, Neck, Muscle, and Joint Injuries Relief Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Cimicifuga racemosa, Cobaltum metallicum, Gnaphalium polycephalum, Hypericum perforatum, Kali carbonicum, Kali phosphoricum, Magnesia phosphorica, Oxalicum acidum, Phosphorus, Rhus toxicodendron, Ruta graveolens, Sepia, Zincum metallicum LIQUID ORAL 20140908 UNAPPROVED HOMEOPATHIC New Sun Inc. ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; COBALT; HORSE CHESTNUT; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; SEPIA OFFICINALIS JUICE; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0035_19c534c3-9c21-4b24-9e1e-4b477a8e0835 66579-0035 HUMAN OTC DRUG Allergies Southern US Adenosinun cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Alnus serrulata, Carduus benedictus, Cichorium intybus, Cortisone aceticum, Dolichos pruriens, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum Mucosa nasalis suis, Nasturtium aquaticum, Natrum muriaticum, Rhus toxicodendron, RNA, Sabadilla, Sassafras officinale LIQUID ORAL 20140730 UNAPPROVED HOMEOPATHIC New Sun Inc. ADENOSINE CYCLIC PHOSPHATE; ALNUS SERRULATA BARK; CENTAUREA BENEDICTA; CHICORY ROOT; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; MUCUNA PRURIENS FRUIT TRICHOME; NASTURTIUM OFFICINALE; ONION; POTASSIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SASSAFRAS ALBIDUM ROOT BARK; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL 66579-0036_442f8b16-ae69-4015-afb5-807cf61f32d1 66579-0036 HUMAN OTC DRUG Allergies Total Mold Control Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Asarum canadense, Cortisone aceticum, Eupatorium aromaticum, Euphrasia officinalis, Fraxinus americana, Galphimia glauca, Helianthus annuus, Histaminum hydrochloricum, Juniperus virginiana, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Plantago major, RNA, Rumex crispus, Sabadilla, Senecio jacobaea LIQUID ORAL 20140804 UNAPPROVED HOMEOPATHIC New Sun Inc. ADENOSINE CYCLIC PHOSPHATE; AGERATINA AROMATICA ROOT; ASARUM CANADENSE ROOT; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; FRAXINUS AMERICANA BARK; GALPHIMIA GLAUCA FLOWERING TOP; HELIANTHUS ANNUUS FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JACOBAEA VULGARIS; JUNIPERUS VIRGINIANA TWIG; ONION; PLANTAGO MAJOR; POTASSIUM CHLORIDE; RUMEX CRISPUS ROOT; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL 66579-0037_3fd0b083-1d2b-4d50-bd50-c431b4567599 66579-0037 HUMAN OTC DRUG Allergies Northeastern US Adenosinum cyclophosphoricum, Adren alinum, Adrenocorticotrophin, Agraphis nutans, allium cepa, Collinsonia canadensis, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Salvia officinalis, Tanacetum vulgare, Trifolium pratense, Vinca minor LIQUID ORAL 20120417 UNAPPROVED HOMEOPATHIC New Sun Inc. ADENOSINE CYCLIC PHOSPHATE; COLLINSONIA CANADENSIS ROOT; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; HYACINTHOIDES NON-SCRIPTA; ONION; POTASSIUM CHLORIDE; RUMEX CRISPUS ROOT; SACCHAROMYCES CEREVISIAE RNA; SAGE; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; TANACETUM VULGARE TOP; TRIFOLIUM PRATENSE FLOWER; VINCA MINOR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL 66579-0038_bab037fb-8655-45b1-864f-a871981800c6 66579-0038 HUMAN OTC DRUG Allergies Total Mold Control Arsenicum album, Baptisia tinctoria, Chloramphenicolum, Echinacea, Elaeis guineensis, Hydrastis canadensis, Hydrastis canadensis, Mercurius solubilis, Myrrha, Nasturtium aquaticum, Nux vomica, Phosphorus, Phytolacca decandra, Pulsatilla, Ricinus communis, Sepia, Xanthoxylum fraxineum LIQUID ORAL 20140805 UNAPPROVED HOMEOPATHIC New Sun Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CHLORAMPHENICOL; ECHINACEA, UNSPECIFIED; ELAEIS GUINEENSIS FRUIT; GOLDENSEAL; MERCURIUS SOLUBILIS; MYRRH; NASTURTIUM OFFICINALE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RICINUS COMMUNIS SEED; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; ZANTHOXYLUM AMERICANUM BARK 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL 66579-0049_9831a2f2-19f4-469e-beed-c4c97c57a7ab 66579-0049 HUMAN OTC DRUG Calm Aconitum napellus, Alfalfa, Argentum nitricum, Avena sativa, Chamomilla, Gelsemium sempervirens, Glonoinum, Histaminum hydrochloricum, Ignatia amara, Kali phosphoricum, Passiflora incarnata, Phosphorus, Veratrum album LIQUID ORAL 20140729 UNAPPROVED HOMEOPATHIC New Sun Inc. ACONITUM NAPELLUS; ALFALFA; AVENA SATIVA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; MATRICARIA RECUTITA; NITROGLYCERIN; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; SILVER NITRATE; STRYCHNOS IGNATII SEED; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL 66579-0055_b46b5e93-2d25-497b-9482-20a75633d2a1 66579-0055 HUMAN OTC DRUG Bio Reset Jet Lag/Shift Change Cocculus indicus, Colchicum autumnale, Gelsemium sempervirens, Juniperus communis, Kali carbonicum, Kali phosphoricum Nux vomica, Passiflora incarnata, Phosphoricum acidum, Phosphorus LIQUID ORAL 20110106 UNAPPROVED HOMEOPATHIC New Sun Inc. ANAMIRTA COCCULUS SEED; COLCHICUM AUTUMNALE BULB; GELSEMIUM SEMPERVIRENS ROOT; JUNIPER BERRY; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0056_0cc79cbd-3d99-4133-b3fe-2967d977805d 66579-0056 HUMAN OTC DRUG ICV Toxi Formula Antimonium crudum, Arsenicum album, Cinchona officinalis, Colocynthis, Gambogia, Gentiana lutea, Magnesia phosphorica, Natrum sulphuricum, Nux vomica, Phosphorus LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC New Sun Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; GAMBOGE; GENTIANA LUTEA ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHORUS; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0057_a0313141-41db-43b0-b885-9d78c5b5ca31 66579-0057 HUMAN OTC DRUG Gout Symptom Reliever Ammonium phosphoricum, Belladonna, Colchicum autumnale, Formicum acidum, Fraxinus excelsior, Ledum palustre, Natrum carbonicum, Nux vomica, Urtica urens LIQUID ORAL 20140829 UNAPPROVED HOMEOPATHIC New Sun Inc. AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; FRAXINUS EXCELSIOR BARK; FRAXINUS EXCELSIOR LEAF; LEDUM PALUSTRE TWIG; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0058_286ae8df-bed4-4800-b3a0-c33a4d13a455 66579-0058 HUMAN OTC DRUG Detox and Drainage, Lymph Belladonna, Calcarea iodata, Conium maculatum, Echinacea purpurea, Hepar sulphuris calcareum, Kali iodatum, Kali muriaticum, Mercurius vivus, Phytolacca decandra, Pulsatilla, Ricinus communis, Scrophularia nodosa, Solidago virgaurea, Sulphur iodatum, LIQUID ORAL 20140908 UNAPPROVED HOMEOPATHIC New Sun Inc. ATROPA BELLADONNA; CALCIUM IODIDE; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; ECHINACEA PURPUREA; MERCURY; PHYTOLACCA AMERICANA ROOT; POTASSIUM CHLORIDE; POTASSIUM IODIDE; PULSATILLA VULGARIS; RICINUS COMMUNIS SEED; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR IODIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0060_cdbc07f9-6bfc-4c39-893c-0fb6ba1a4607 66579-0060 HUMAN OTC DRUG Headache Relief II Gelsemium sempervirens, Glonoinum, Iris versicolor, Kali carbonicum, Lycopodium clavatum, Natrum muriaticum, Niccolum metallicum, Nux vomica, Sanguinaria canadensis, Secale cornutum, Spigelia anthelmia, Sulphur LIQUID ORAL 20110428 UNAPPROVED HOMEOPATHIC New Sun Inc. CLAVICEPS PURPUREA SCLEROTIUM; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; NICKEL; NITROGLYCERIN; POTASSIUM CARBONATE; SANGUINARIA CANADENSIS ROOT; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0061_e86d9c4d-d19e-41b2-88d4-fd95fb9c33e2 66579-0061 HUMAN OTC DRUG Yeast Freee Abies nigra, Antimonium crudum, Asafoetida, Baptisia tinctoria, Borax, Candida albicans, Lachesis mutus, Phytolacca decandra, Phosphoricum acidum, Pulsatilla, Sticta pulmonaria, Sulphur, Thuja occidentalis LIQUID ORAL 20140819 UNAPPROVED HOMEOPATHIC New Sun Inc. ANTIMONY TRISULFIDE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; CANDIDA ALBICANS; LACHESIS MUTA VENOM; LOBARIA PULMONARIA; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PICEA MARIANA RESIN; PULSATILLA VULGARIS; SODIUM BORATE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0064_68510a4a-d5ed-40e9-b3cd-6d4a4f9e1cfd 66579-0064 HUMAN OTC DRUG Constitutional Immuno Aconitum napellus, Arsenicum album,Baryta carbonica, Bryonia, Calcarea carbonica, Cantharis, Gelsemium sempervirens, Graphites, Hydrastis canadensis, Kali carbonicum, Lachesis mutus, Lycopodium clavatum, Mercurius vivus, Natrum muriaticum, Nux vomica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhus toxicodendron, Sepia, Silicea, Sulphur LIQUID ORAL 20140730 UNAPPROVED HOMEOPATHIC New Sun Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; GRAPHITE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MERCURY; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0065_cf980642-bf60-4308-bd7b-84f441d897f3 66579-0065 HUMAN OTC DRUG Allergies Foundational Formula Adenosinum cyclophosphoricum, Adrenocorticotrophin, Allium cepa, Arsenicum album, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Sabadilla LIQUID ORAL 20140716 UNAPPROVED HOMEOPATHIC New Sun Inc. ADENOSINE CYCLIC PHOSPHATE; ARSENIC TRIOXIDE; CORTICOTROPIN; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; ONION; POTASSIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL 66579-0067_9825b009-6638-4a73-89df-849e0eeb4b60 66579-0067 HUMAN OTC DRUG Lungs and Bronchial Relief Ammonium carbonicum, Antimonium arsenicicum, Antimonium tartaricum, Arsenicum album, Bromium, Carbo vegetabilis, Chlorinum, Kali carbonicum, Lobelia inflata, Stannum metallicum, Sulphuricum acidum LIQUID ORAL 20140717 UNAPPROVED HOMEOPATHIC New Sun Inc. ACTIVATED CHARCOAL; AMMONIUM CARBONATE; ANTIMONY ARSENATE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BROMINE; CHLORINE; LOBELIA INFLATA; POTASSIUM CARBONATE; SULFURIC ACID; TIN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0069_c2f87820-19f7-4679-902b-8e6e74cd4b8f 66579-0069 HUMAN OTC DRUG Anti-Aging and Wrinkles Abrotanum, Anacardium orientale, Arsenicum album, Baryta Carbonica, Baryta muriatica, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Ferrum metallicum, Fucus vesiculosus, Hekla lava, Helleborus niger, Ignatia amara, Lycopodium clavatum, Nicotinamidum, Secale cornutum, Silicea LIQUID ORAL 20140729 UNAPPROVED HOMEOPATHIC New Sun Inc. ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CALCIUM FLUORIDE; CLAVICEPS PURPUREA SCLEROTIUM; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; IRON; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; STRYCHNOS IGNATII SEED; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0070_77460a04-b411-4236-8cdf-1dcc4704227e 66579-0070 HUMAN OTC DRUG Weight and Appetite Control Abies canadensis, Ammonium bromatum, Ammonium muriaticum, Anacardium orientale, Antimonium crudum, Argentum metallicum, Calcarea carbonica, Capsicum annuum, Cinchona officinalis, Ferrum metallicum, Fucus vesiculosus, Ignatia amara, Kali bichromicum, Lycopodium clavatum, Mercurius solubilis, Natrum sulphuricum, Oleander, Phosphorus, Phytolacca decandra, Sabadilla, Staphysagria, Sulphur, Thyroidinum, Veratrum album LIQUID ORAL 20110824 UNAPPROVED HOMEOPATHIC New Sun Inc. AMMONIUM BROMIDE; AMMONIUM CHLORIDE; ANTIMONY TRISULFIDE; CAPSICUM; CINCHONA OFFICINALIS BARK; DELPHINIUM STAPHISAGRIA SEED; FUCUS VESICULOSUS; IRON; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NERIUM OLEANDER LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; SCHOENOCAULON OFFICINALE SEED; SEMECARPUS ANACARDIUM JUICE; SILVER; SODIUM SULFATE; STRYCHNOS IGNATII SEED; SULFUR; THYROID, UNSPECIFIED; TSUGA CANADENSIS BARK; TSUGA CANADENSIS FLOWER BUD; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0075_5d98074b-6d44-485a-816e-121b9043879c 66579-0075 HUMAN OTC DRUG Smoke Freee Arsenicum album, Caladium seguinum, Carbolicum acidum, Daphne indica, Eugenia jambosa, Kali phosphoricum, Lobelia inflata, Nicotinum, Nux vomica, Plantago major, Saccharum officinale, Staphysagria, Tabacum, Thuja occidentalis LIQUID ORAL 20120202 UNAPPROVED HOMEOPATHIC New Sun Inc. ARSENIC TRIOXIDE; DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; LOBELIA INFLATA; NICOTINE; PHENOL; PLANTAGO MAJOR; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; SUCROSE; SYZYGIUM JAMBOS SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0078_f14cff3e-b098-4bcd-b349-896c98c064af 66579-0078 HUMAN OTC DRUG Bladder Incontinence Formula Belladonna, Bellis perennis, Benzoicum acidum, Benzoicum acidum, Causticum, Equisetum hyemale, Lycopodium clavatum, Phosphorus, Plantago major, Rhus aromatica, Sepia LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC New Sun Inc. ATROPA BELLADONNA; BELLIS PERENNIS; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0079_e915d6b6-3b00-430c-82e2-18b1f187c9d6 66579-0079 HUMAN OTC DRUG Allergy and Red Eye Relief Aconitum napellus, Allium cepa, Ambrosia artemisiaefolia, Apis mellifica, arsenicum album, Belladonna, Cactus grandiflorus, Dulcamara, Euphrasia officinalis, Gelsemium sempervirens, Graphites, Hamamelis virginiana, Hepar sulphuris calcareum, Kali iodatum, Mercurius vivus, Natrum muriaticum, Pulsatilla, Rhus toxicodendron, Ruta graveolens, Sabadilla, Sulphur, Thuja occidentalis, Zincum metallicum LIQUID ORAL 20141020 UNAPPROVED HOMEOPATHIC New Sun Inc. ACONITUM NAPELLUS; AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CALCIUM SULFIDE; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MERCURY; ONION; POTASSIUM IODIDE; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; SELENICEREUS GRANDIFLORUS STEM; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0080_c5335667-d8ef-4a77-b161-23f6fc099c18 66579-0080 HUMAN OTC DRUG Menopause Amyl nitrosum, Calcarea carbonica, Caulophyllum thalictroides, Cimicifuga racemosa, Ferrum metallicum, Gelsemium sempervirens, Lachesis mutus, Pulsatilla, Sanguinaria canadensis, Sepia, Sulphur, Sulphuricum acidum LIQUID ORAL 20120222 UNAPPROVED HOMEOPATHIC New Sun Inc. AMYL NITRITE; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; GELSEMIUM SEMPERVIRENS ROOT; IRON; LACHESIS MUTA VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SULFUR; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66579-0090_18089f3e-d601-4140-a539-49256ab77a25 66579-0090 HUMAN OTC DRUG Colds and Flu/Multi Symptom Reliever Arsenicum album, Baptisia tinctoria, Bryonia, Dulcamara, Echinacea, Echinacea purpurea, Eupatorium purpureum, Ferrum phosphoricum, Gelsemium sempervirens, Kali muriaticum, Phosphorus, Pulsatilla, Sulphur, Zincum aceticum, Zincum carbonicum, Zincum metallicum, Zincum muriaticum, Zincum oxydatum, Zincum picricum, Zincum valerianicum LIQUID ORAL 20140820 UNAPPROVED HOMEOPATHIC New Sun Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; ECHINACEA PURPUREA; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORUS; POTASSIUM CHLORIDE; PULSATILLA VULGARIS; SOLANUM DULCAMARA TOP; SULFUR; ZINC; ZINC ACETATE ANHYDROUS; ZINC CARBONATE; ZINC CHLORIDE; ZINC OXIDE; ZINC PICRATE NONAHYDRATE; ZINC VALERATE DIHYDRATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 66582-311_c1513088-ed6a-44a8-910e-42fb694bb7e8 66582-311 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 Merck Sharp & Dohme Corp. EZETIMIBE; SIMVASTATIN 10; 10 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66582-312_c1513088-ed6a-44a8-910e-42fb694bb7e8 66582-312 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 Merck Sharp & Dohme Corp. EZETIMIBE; SIMVASTATIN 10; 20 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66582-313_c1513088-ed6a-44a8-910e-42fb694bb7e8 66582-313 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 Merck Sharp & Dohme Corp. EZETIMIBE; SIMVASTATIN 10; 40 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66582-315_c1513088-ed6a-44a8-910e-42fb694bb7e8 66582-315 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 Merck Sharp & Dohme Corp. EZETIMIBE; SIMVASTATIN 10; 80 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66582-320_347a5713-b2be-4df2-87fe-0bea7ff1c0ad 66582-320 HUMAN PRESCRIPTION DRUG LIPTRUZET ezetimibe and atorvastatin TABLET, FILM COATED ORAL 20130503 NDA NDA200153 Merck Sharp & Dohme Corp. ATORVASTATIN CALCIUM; EZETIMIBE 10; 10 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66582-321_347a5713-b2be-4df2-87fe-0bea7ff1c0ad 66582-321 HUMAN PRESCRIPTION DRUG LIPTRUZET ezetimibe and atorvastatin TABLET, FILM COATED ORAL 20130503 NDA NDA200153 Merck Sharp & Dohme Corp. ATORVASTATIN CALCIUM; EZETIMIBE 20; 10 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66582-322_347a5713-b2be-4df2-87fe-0bea7ff1c0ad 66582-322 HUMAN PRESCRIPTION DRUG LIPTRUZET ezetimibe and atorvastatin TABLET, FILM COATED ORAL 20130503 NDA NDA200153 Merck Sharp & Dohme Corp. ATORVASTATIN CALCIUM; EZETIMIBE 40; 10 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66582-323_347a5713-b2be-4df2-87fe-0bea7ff1c0ad 66582-323 HUMAN PRESCRIPTION DRUG LIPTRUZET ezetimibe and atorvastatin TABLET, FILM COATED ORAL 20130503 NDA NDA200153 Merck Sharp & Dohme Corp. ATORVASTATIN CALCIUM; EZETIMIBE 80; 10 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66582-414_118dae5a-a857-4edd-9c64-dbb9ecee7942 66582-414 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20021025 NDA NDA021445 Merck Sharp & Dohme Corp. EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] 66586-1073_3bfe5567-9570-427d-9297-e51bb2b0fd07 66586-1073 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20050101 UNAPPROVED MEDICAL GAS Merwin Home Medical dba Robin Drup Corp. OXYGEN 99 L/100L 66593-3125_a8e22fc7-9201-471f-aa68-808a7fe3978b 66593-3125 HUMAN PRESCRIPTION DRUG Vancocin vancomycin hydrochloride CAPSULE ORAL 19860415 NDA NDA050606 ViroPharma VANCOMYCIN HYDROCHLORIDE 125 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 66593-3126_a8e22fc7-9201-471f-aa68-808a7fe3978b 66593-3126 HUMAN PRESCRIPTION DRUG Vancocin vancomycin hydrochloride CAPSULE ORAL 19860415 NDA NDA050606 ViroPharma VANCOMYCIN HYDROCHLORIDE 250 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 66594-321_43da4965-15ef-4716-95a6-ea67a636ae43 66594-321 HUMAN OTC DRUG PRO-CHLO Chlophedianol Hydrochloride, Phenylephrine Hydrochloride, Pyrilamine Maleate LIQUID ORAL 20111212 OTC MONOGRAPH FINAL part341 Pro-Pharma, LLC CHLOPHEDIANOL HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE 12.5; 5; 12.5 mg/5mL; mg/5mL; mg/5mL 66594-333_a63ff20f-e825-4b62-b7e1-775ec3ab4b80 66594-333 HUMAN OTC DRUG PRO-CLEAR AC Codeine Phosphate and Pyrilamine Maleate SYRUP ORAL 20080908 OTC MONOGRAPH FINAL part341 Pro-Pharma LLC CODEINE PHOSPHATE; PYRILAMINE MALEATE 9; 8.33 mg/5mL; mg/5mL CV 66594-499_cc958709-6208-4ae0-8d57-2361bf78d826 66594-499 HUMAN OTC DRUG PRO-RED AC Codeine Phosphate, Dexchorpheniramine Maleate, Phenylephrine Hydrochloride SYRUP ORAL 20130930 OTC MONOGRAPH FINAL part341 Pro-Pharma, LLC CODEINE PHOSPHATE; DEXCHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 9; 1; 5 mg/5mL; mg/5mL; mg/5mL CV 66608-515_46c1ccb5-6129-4585-99f0-80f3539f1d0d 66608-515 HUMAN OTC DRUG Vindicator Instant Hand Sanitizer alcohol GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 Kimball Midwest ALCOHOL 600 mL/1000mL 66613-8142_0637c366-969c-4eec-810e-a8914a09bf47 66613-8142 HUMAN OTC DRUG Rohto Cool Naphazoline hydrochloride, Polysorbate LIQUID OPHTHALMIC 20010821 OTC MONOGRAPH FINAL part349 Rohto Pharmaceutical Co Ltd NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80 .12; 2 mg/mL; mg/mL 66613-8143_b2d9111e-a88d-49b2-87ad-e826d8fe0c97 66613-8143 HUMAN OTC DRUG Rohto Ice Hypromellose, Tetrahydrozoline HCl, Zinc sulfate LIQUID OPHTHALMIC 20050927 OTC MONOGRAPH FINAL part349 Rohto Pharmaceutical Co Ltd HYPROMELLOSES; TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE 2; .5; 2.5 mg/mL; mg/mL; mg/mL 66613-8144_e0fc747e-d7ec-4852-9599-69c014aa03f5 66613-8144 HUMAN OTC DRUG Rohto Arctic Hypromellose, Tetrahydrozoline hydrochloride LIQUID OPHTHALMIC 20060824 OTC MONOGRAPH FINAL part349 Rohto Pharmaceutical Co Ltd HYPROMELLOSES; TETRAHYDROZOLINE HYDROCHLORIDE 3.5; .5 mg/mL; mg/mL 66613-8148_8c282777-d644-4820-b288-d00c2e1e5114 66613-8148 HUMAN OTC DRUG Rohto Hydra Hydroxyethyl cellulose LIQUID OPHTHALMIC 20110103 OTC MONOGRAPH FINAL part349 Rohto Pharmaceutical Co. Ltd. HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) 6 mg/mL 66613-8149_046b6903-861b-4abe-8986-58e2ae8c966b 66613-8149 HUMAN OTC DRUG Rohto Relief hypromellose, tetrahydrozoline HCl, zinc sulfate LIQUID OPHTHALMIC 20111201 OTC MONOGRAPH FINAL part349 Rohto Pharmaceutical Co Ltd HYPROMELLOSES; TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE 2; .5; 2.5 mg/mL; mg/mL; mg/mL 66613-8159_b3c35906-151e-4a2f-b27d-2e90627d6273 66613-8159 HUMAN OTC DRUG Rohto Cool Max Naphazoline hydrochloride, Polysorbate 80 LIQUID OPHTHALMIC 20140505 OTC MONOGRAPH FINAL part349 Rohto Pharmaceutical Co. Ltd. NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80 .3; 2 mg/mL; mg/mL 66621-0150_1af197eb-94a9-449a-9667-1e3911255e43 66621-0150 HUMAN PRESCRIPTION DRUG ANASCORP CENTRUROIDES (Scorpion) IMMUNE F(ab)2 (EQUINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110803 BLA BLA125335 Rare Disease Therapeutics, Inc CENTRUROIDES FAB2 ANTIVENIN (EQUINE) 24 mg/mL Antivenin [EPC],Passively Acquired Immunity [PE],Venom Neutralization [MoA],Antivenins [Chemical/Ingredient] 66621-1002_26ff8b9d-8138-4176-807e-da779bb3004e 66621-1002 HUMAN PRESCRIPTION DRUG ORFADIN nitisinone CAPSULE ORAL 20020118 20150731 NDA NDA021232 Rare Disease Therapeutics, Inc. NITISINONE 2 mg/1 Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA] 66621-1005_26ff8b9d-8138-4176-807e-da779bb3004e 66621-1005 HUMAN PRESCRIPTION DRUG ORFADIN nitisinone CAPSULE ORAL 20020118 20150731 NDA NDA021232 Rare Disease Therapeutics, Inc. NITISINONE 5 mg/1 Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA] 66621-1010_26ff8b9d-8138-4176-807e-da779bb3004e 66621-1010 HUMAN PRESCRIPTION DRUG ORFADIN nitisinone CAPSULE ORAL 20020118 20150731 NDA NDA021232 Rare Disease Therapeutics, Inc. NITISINONE 10 mg/1 Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA] 66621-4000_7cd3e5d2-1cc8-4757-a098-9530b24f3b32 66621-4000 HUMAN PRESCRIPTION DRUG Cystadane betaine POWDER, FOR SOLUTION ORAL 19961025 NDA NDA020576 Rare Disease Therapeutics, Inc. BETAINE 6 g/1 Methylating Activity [MoA],Methylating Agent [EPC] 66657-301_91011848-9bcb-4ccc-83b1-a53c4d8e219b 66657-301 HUMAN PRESCRIPTION DRUG GANITE Gallium nitrate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20030917 NDA NDA019961 Genta Incorporated GALLIUM NITRATE 25 mg/mL 66658-102_7f2f99ca-faa2-42e6-b72a-a1eb82666e59 66658-102 HUMAN PRESCRIPTION DRUG Orfadin Nitisinone CAPSULE ORAL 20140401 NDA NDA021232 SWEDISH ORPHAN BIOVITRUM AB (PUBL) NITISINONE 2 mg/1 Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA] 66658-105_7f2f99ca-faa2-42e6-b72a-a1eb82666e59 66658-105 HUMAN PRESCRIPTION DRUG Orfadin Nitisinone CAPSULE ORAL 20140401 NDA NDA021232 SWEDISH ORPHAN BIOVITRUM AB (PUBL) NITISINONE 5 mg/1 Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA] 66658-110_7f2f99ca-faa2-42e6-b72a-a1eb82666e59 66658-110 HUMAN PRESCRIPTION DRUG Orfadin Nitisinone CAPSULE ORAL 20140401 NDA NDA021232 SWEDISH ORPHAN BIOVITRUM AB (PUBL) NITISINONE 10 mg/1 Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA] 66658-112_1cf1e381-844f-4c03-8c6f-581b0b79b3bf 66658-112 HUMAN PRESCRIPTION DRUG Kepivance palifermin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091215 BLA BLA125103 Swedish Orphan Biovitrum AB (publ) PALIFERMIN 6.25 mg/1.2mL Fibroblast Growth Factor 7 [Chemical/Ingredient],Increased Epithelial Proliferation [PE],Mucocutaneous Epithelial Cell Growth Factor [EPC] 66658-234_5888e955-91e4-4c46-95bb-46e7ba8d0aa1 66658-234 HUMAN PRESCRIPTION DRUG Kineret anakinra INJECTION, SOLUTION SUBCUTANEOUS 20091215 BLA BLA103950 Swedish Orphan Biovitrum AB (publ) ANAKINRA 100 mg/.67mL Interleukin 1 Receptor Antagonists [MoA],Interleukin-1 Receptor Antagonist [EPC] 66663-103_eea6a0b9-3f5f-4726-a59d-63d36cbe78f3 66663-103 HUMAN PRESCRIPTION DRUG AVC Vaginal sulfanilamide CREAM VAGINAL 19650605 NDA NDA006530 Jazz Pharmaceuticals Commercial Corp. SULFANILAMIDE 15 g/100g 66663-219_693eb049-72dc-4a8b-92b9-5bbd65c058c2 66663-219 HUMAN PRESCRIPTION DRUG Urelle hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate TABLET ORAL 20020101 UNAPPROVED DRUG OTHER Jazz Pharmaceuticals Commercial Corp. HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .12; 81; 10.8; 32.4; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1 66685-1001_1a9f0915-df68-4167-b484-6bba58095be3 66685-1001 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021121 ANDA ANDA065093 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 66685-1002_1a9f0915-df68-4167-b484-6bba58095be3 66685-1002 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021127 ANDA ANDA065117 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 66685-1011_1a9f0915-df68-4167-b484-6bba58095be3 66685-1011 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20040813 ANDA ANDA065098 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 66685-1012_1a9f0915-df68-4167-b484-6bba58095be3 66685-1012 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20040813 ANDA ANDA065098 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 66689-008_c47643bb-a732-4652-a9c7-4f1cba7609e0 66689-008 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20120501 ANDA ANDA065422 VistaPharm Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 66689-009_45471b6a-07c5-4303-8108-65ae35718276 66689-009 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20120816 ANDA ANDA074978 VistaPharm, Inc. IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66689-020_df2d1fe3-3a4b-4d50-9abf-52b51b9c93a2 66689-020 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20120822 ANDA ANDA075671 VistaPharm, Inc. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 66689-023_d529e9a6-1036-42ba-9215-068e07cba97e 66689-023 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen SOLUTION ORAL 20120220 ANDA ANDA200343 VistaPharm Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII 66689-025_f2a55f54-3c43-4de5-8380-f924c8a6a2a9 66689-025 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20120815 ANDA ANDA202537 VistaPharm, Inc. OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 66689-028_3802e015-d1cc-43ae-9144-42e8f4d49c70 66689-028 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20100125 ANDA ANDA078976 VistaPharm, Inc LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 66689-031_eb7f2aed-5c8b-4ab5-bdc2-3c7fdfa916ac 66689-031 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride SOLUTION ORAL 20100212 ANDA ANDA075051 VistaPharm Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 66689-032_f46689af-6985-4d7a-a29a-6eef570ea963 66689-032 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20120301 ANDA ANDA201947 VistaPharm Inc. MORPHINE SULFATE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 66689-033_f46689af-6985-4d7a-a29a-6eef570ea963 66689-033 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20120301 ANDA ANDA201947 VistaPharm Inc. MORPHINE SULFATE 20 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 66689-036_594306c3-9ccc-4cb1-b338-4362f25773e4 66689-036 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20100510 ANDA ANDA040342 VistaPharm Inc. PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 66689-037_d6909bbf-a121-43c8-ad0c-5bc9f64c8c1d 66689-037 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20100510 ANDA ANDA064142 VistaPharm, Inc NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 66689-038_7845c8aa-e4eb-4aae-8242-c2073fe180b6 66689-038 HUMAN PRESCRIPTION DRUG LACTULOSE LACTULOSE SOLUTION ORAL 20100510 ANDA ANDA074138 VistaPharm, Inc LACTULOSE 20 g/30mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 66689-039_7845c8aa-e4eb-4aae-8242-c2073fe180b6 66689-039 HUMAN PRESCRIPTION DRUG LACTULOSE LACTULOSE SOLUTION ORAL 20100510 ANDA ANDA074138 VistaPharm, Inc LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 66689-201_1f9c3884-566a-4919-a5de-08ba71961534 66689-201 HUMAN OTC DRUG INSTA-CHAR AQUEOUS POISON TREATMENT ADSORBENT SUSPENSION SUSPENSION ORAL 20061003 OTC MONOGRAPH NOT FINAL part357 VISTAPHARM INC ACTIVATED CHARCOAL 50 g/240mL 66689-202_b4e1ac0c-c106-4c8f-abdf-72c165dba08e 66689-202 HUMAN OTC DRUG INSTA-CHAR AQUEOUS CHERRY POISON TREATMENT ADSORBENT SUSPENSION SUSPENSION ORAL 20071211 OTC MONOGRAPH NOT FINAL part357 VISTAPHARM INC ACTIVATED CHARCOAL 50 g/240mL 66689-203_f99ae4d7-0bae-440c-a9a0-1ef5fe75ba74 66689-203 HUMAN OTC DRUG INSTA-CHAR SORBITOL POISON TREATMENT ADSORBENT SUSPENSION SUSPENSION ORAL 20080328 OTC MONOGRAPH NOT FINAL part357 VISTAPHARM INC ACTIVATED CHARCOAL 50 g/240mL 66689-401_1da6295d-d01a-42d0-b9cd-a213a4b87e48 66689-401 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20120315 NDA NDA201194 VistaPharm Inc. OXYCODONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 66689-403_1da6295d-d01a-42d0-b9cd-a213a4b87e48 66689-403 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20120315 NDA NDA201194 VistaPharm Inc. OXYCODONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 66689-694_2c783c74-4fbc-48cc-87be-a77dac934d87 66689-694 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride CONCENTRATE ORAL 20091030 ANDA ANDA040088 VistaPharm Inc METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 66689-695_2c783c74-4fbc-48cc-87be-a77dac934d87 66689-695 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride CONCENTRATE ORAL 20111201 ANDA ANDA040088 VistaPharm Inc METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 66689-711_ae5ad2f5-404f-409a-8283-b760989e2f6f 66689-711 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride SOLUTION ORAL 20100801 ANDA ANDA090707 VistaPharm Inc METHADONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 66689-712_ae5ad2f5-404f-409a-8283-b760989e2f6f 66689-712 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride SOLUTION ORAL 20100801 ANDA ANDA090707 VistaPharm Inc METHADONE HYDROCHLORIDE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 66689-790_7aa1261e-a731-4f08-849f-03a1ce65c5c1 66689-790 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate SUSPENSION ORAL 20120816 NDA NDA019183 VistaPharm, Inc. SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 66689-810_d173904f-c6e4-4094-8d62-99052f228ab5 66689-810 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 19980529 ANDA ANDA040241 VistaPharm, Inc. METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 66689-898_89e14157-ad0c-4c55-9db1-716cacec31c2 66689-898 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 19980325 ANDA ANDA075082 VistaPharm, Inc. METHADONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 66694-001_29695452-f329-4875-aa6a-1d46f23b2d77 66694-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Procaire, LLC OXYGEN 99 L/100L 66715-4905_62d16a09-1352-4bfb-9de5-255dd902df8b 66715-4905 HUMAN OTC DRUG Legatrin PM Acetaminophen and Diphenhydramine Hydrochloride TABLET ORAL 20091102 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 50 mg/1; mg/1 66715-5301_559c7bf9-920a-4117-8a67-a971c3d822e7 66715-5301 HUMAN OTC DRUG Goodys Cool Orange Acetaminophen, Aspirin, and Caffeine POWDER ORAL 20140301 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 325; 500; 65 mg/1; mg/1; mg/1 66715-5631_ab2bac94-f014-4ba9-9e19-666fbfa00f5d 66715-5631 HUMAN OTC DRUG Daytime Cold and Flu Circle K Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20141101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 66715-5637_44dd1b82-8da3-4f0a-b45e-40f0cf4ae36c 66715-5637 HUMAN OTC DRUG Circle K Pain Reliever Acetaminophen TABLET ORAL 20141101 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc ACETAMINOPHEN 500 mg/1 66715-5728_e21fd85c-06da-447d-a8f0-a47b0cbe51bf 66715-5728 HUMAN OTC DRUG Circle K Cold Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20141101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 66715-5730_7b5ec337-6d2a-4191-a7f7-7d299181cbb3 66715-5730 HUMAN OTC DRUG Circle K NoSnooze Caffeine TABLET ORAL 20141101 OTC MONOGRAPH FINAL part340 Lil' Drug Store Products, Inc CAFFEINE 200 mg/1 66715-5731_ab2bac94-f014-4ba9-9e19-666fbfa00f5d 66715-5731 HUMAN OTC DRUG Daytime Cold and Flu Circle K Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20141101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 66715-5734_bdb14ba4-7e2b-4a35-a852-ef65369f7f13 66715-5734 HUMAN OTC DRUG Circle K Nighttime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20141101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 66715-5737_44dd1b82-8da3-4f0a-b45e-40f0cf4ae36c 66715-5737 HUMAN OTC DRUG Circle K Pain Reliever Acetaminophen TABLET ORAL 20141101 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc ACETAMINOPHEN 500 mg/1 66715-5738_b9eeccee-a2f5-4299-822d-4fdbc078a8ce 66715-5738 HUMAN OTC DRUG Circle K Headache Relief Acetaminophen, Aspirin, and Caffeine TABLET ORAL 20141101 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 66715-5739_e5a7e517-1797-441e-9d3b-09f1ba4ad812 66715-5739 HUMAN OTC DRUG Circle K Ibuprofen Ibuprofen TABLET, COATED ORAL 20141101 ANDA ANDA075010 Lil' Drug Store Products, Inc IBUPROFEN 200 mg/1 66715-5744_8bf3b747-1fed-4f23-852c-f16de8381452 66715-5744 HUMAN OTC DRUG Circle K Multi-Symptom Sinus Relief Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20110601 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 66715-5754_65694734-cb7f-4404-8f11-6fc6d5880dd4 66715-5754 HUMAN OTC DRUG Circle K Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20141101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 66715-5755_30bda851-65d0-435c-a9ac-f24794bef2ba 66715-5755 HUMAN OTC DRUG Circle K Stomach Bismuth Subsalicylate LIQUID ORAL 20141101 OTC MONOGRAPH FINAL part335 Lil' Drug Store Products, Inc BISMUTH SUBSALICYLATE 525 mg/30mL 66715-5759_83f542a5-78c0-4048-8b62-5477dd54e28e 66715-5759 HUMAN OTC DRUG Circle K Anti-Diarrheal Loperamide Hydrochloride TABLET ORAL 20141101 NDA NDA021855 Lil' Drug Store Products, Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 66715-5760_8bc09489-7bf2-4fb2-9a50-7772e8117c9e 66715-5760 HUMAN OTC DRUG Circle K Congestion Relief Oxymetazoline Hydrochloride SPRAY NASAL 20141101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 66715-5761_f831b3e6-a2ba-4f86-be34-79768c07c8e9 66715-5761 HUMAN OTC DRUG Hand Sanitizer Circle K Alcohol GEL TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part333E Lil' Drug Store Products, Inc ALCOHOL 70 mL/100mL 66715-5762_d25c2730-ece4-4b79-82f0-6d98ec84d00f 66715-5762 HUMAN OTC DRUG Antibacterial Hand Wipes Circle K Benzalkonium chloride CLOTH TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part333A Lil' Drug Store Products, Inc BENZALKONIUM CHLORIDE 1.3 mg/1 66715-5831_28cdafe4-d0fb-44c0-b5af-d6a06e8606ca 66715-5831 HUMAN OTC DRUG Circle K Daytime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride LIQUID ORAL 20141101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 66715-5834_34eba204-e015-41e4-9a3c-1eefa31408a4 66715-5834 HUMAN OTC DRUG Circle K Nighttime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate LIQUID ORAL 20141101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 66715-5854_65694734-cb7f-4404-8f11-6fc6d5880dd4 66715-5854 HUMAN OTC DRUG Circle K Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20141101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 66715-5954_65694734-cb7f-4404-8f11-6fc6d5880dd4 66715-5954 HUMAN OTC DRUG Circle K Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20141101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 66715-6831_faf2a015-984a-4c67-9cac-0767b7d72eab 66715-6831 HUMAN OTC DRUG Cold and Flu Daytime Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140905 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 66715-6834_32d85c14-6e1e-4220-8754-47568823112a 66715-6834 HUMAN OTC DRUG Cold and Flu Nighttime Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20140905 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 66715-6843_d6fdbb4e-1c1a-48c3-ad8c-631607345246 66715-6843 HUMAN OTC DRUG Nighttime Sleep-Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140905 OTC MONOGRAPH FINAL part338 Lil' Drug Store Products, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 66715-6845_37a07482-ef67-4d6e-825a-9804429ee24b 66715-6845 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Lil Drug Store Products Isopropyl alcohol LIQUID TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part333A Lil' Drug Store Products, Inc ISOPROPYL ALCOHOL 500 mg/mL 66715-6846_b29e2d28-fd82-486a-bc08-7a93a7a5c329 66715-6846 HUMAN OTC DRUG Hydrogen Peroxide Lil Drug Store Products Hydrogen Peroxide LIQUID TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part333A Lil' Drug Store Products, Inc HYDROGEN PEROXIDE 3 mL/100mL 66715-6850_07b7096d-a531-4a1a-a003-cc535fccfc6f 66715-6850 HUMAN OTC DRUG 24 Hour Allergy Lil Drug Store Products Cetirizine hydrochloride TABLET ORAL 20141101 ANDA ANDA078780 Lil' Drug Store Products, Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 66715-6855_881e2abb-8af8-4711-979d-4e85510ec872 66715-6855 HUMAN OTC DRUG Stomach Lil Drug Store Products Bismuth Subsalicylate LIQUID ORAL 20141201 OTC MONOGRAPH FINAL part335 Lil' Drug Store Products, Inc BISMUTH SUBSALICYLATE 525 mg/30mL 66715-6856_66578fe5-6ae2-4ec1-b940-1063c1f05b2e 66715-6856 HUMAN OTC DRUG Childrens Pain and Fever Lil Drug Store Products Acetaminophen LIQUID ORAL 20141201 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc ACETAMINOPHEN 160 mg/5mL 66715-6858_e687259e-b7e4-498a-b2d0-c3683a6cc752 66715-6858 HUMAN OTC DRUG Adult Tussin DM Lil Drug Store Products Dextromethorphan Hydrobromide and Guaifenesin LIQUID ORAL 20141201 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 66715-6860_3d2bc2ec-2383-436a-ab64-bc42c6022281 66715-6860 HUMAN OTC DRUG Congestion Relief Lil Drug Store Products Oxymetazoline Hydrochloride SPRAY NASAL 20141201 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 66715-6861_7f092f11-2c30-49b9-ae7c-300cc0f547b6 66715-6861 HUMAN OTC DRUG Antiseptic Lil Drug Store Products Eucalyptol, Menthol, Unspecified Form, Methyl salicylate, and Thymol LIQUID ORAL 20141201 OTC MONOGRAPH NOT FINAL part356 Lil' Drug Store Products, Inc EUCALYPTOL; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 66715-6931_ac7c58d6-3135-467b-99a3-03605af0e091 66715-6931 HUMAN OTC DRUG Daytime Cold and Flu Lil Drug Store Products Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride LIQUID ORAL 20141201 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 66715-6934_737275c9-2118-42d6-833d-0961e4b52964 66715-6934 HUMAN OTC DRUG Nighttime Cold and Flu Lil Drug Store Products Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate LIQUID ORAL 20141201 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 66715-9700_0eb9881b-8bd2-4ad6-872f-e05813d5b3f1 66715-9700 HUMAN OTC DRUG Advil Ibuprofen TABLET, COATED ORAL 20100222 NDA NDA018989 Lil' Drug Store Products, Inc. IBUPROFEN 200 mg/1 66715-9702_7af0475d-33d5-4c13-ad06-5bb66465eb94 66715-9702 HUMAN OTC DRUG Aleve Naproxen Sodium TABLET ORAL 20000101 NDA NDA020204 Lil' Drug Store Products, Inc NAPROXEN SODIUM 220 mg/1 66715-9704_760515e1-dfae-40b8-b6ca-450eafe842c6 66715-9704 HUMAN OTC DRUG DayQuil Severe Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20130701 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 66715-9706_fc926f1b-800d-4a65-a2a8-a8a736ee5173 66715-9706 HUMAN OTC DRUG Benadryl Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20100916 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 66715-9707_fea699e4-6a51-4ba5-8f70-d78defbcab46 66715-9707 HUMAN OTC DRUG Allegra Allergy Fexofenadine Hydrochloride TABLET ORAL 20140901 NDA NDA020872 Lil' Drug Store Products, Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 66715-9708_99eb2139-f82e-4b87-babb-6c9ae16d7718 66715-9708 HUMAN OTC DRUG DayQuil Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20100916 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 66715-9709_23eb7c64-9642-4cc0-bcfd-90483722143b 66715-9709 HUMAN OTC DRUG Dramamine Dimenhydrinate TABLET, CHEWABLE ORAL 20100510 OTC MONOGRAPH FINAL part336 Lil' Drug Store Products, Inc. DIMENHYDRINATE 50 mg/1 66715-9710_86e0b034-0a75-4376-9c5d-52fcb7f26ca8 66715-9710 HUMAN OTC DRUG Excedrin Extra Strength Acetaminophen, Aspirin, and Caffeine TABLET ORAL 20100510 OTC MONOGRAPH FINAL part343 Lil' Drug Store Products, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 66715-9712_991872d6-18a5-4edb-9547-dadeb440da2c 66715-9712 HUMAN OTC DRUG Motrin IB Ibuprofen TABLET, COATED ORAL 20100510 NDA NDA019012 Lil' Drug Store Products, Inc. IBUPROFEN 200 mg/1 66715-9713_44d470ae-5245-4ac7-afdf-a1f1ab3f8d32 66715-9713 HUMAN OTC DRUG NyQuil Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20100916 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 66715-9720_cfde4a27-e410-40a9-ad01-1011f2fbbb61 66715-9720 HUMAN OTC DRUG Imodium AD Loperamide Hydrochloride TABLET, COATED ORAL 20100510 NDA NDA019860 Lil' Drug Store Products, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 66715-9723_045455cf-fd71-409a-be8b-60b2796f057c 66715-9723 HUMAN OTC DRUG Pepto-Bismol Bismuth subsalicylate TABLET, CHEWABLE ORAL 20100916 OTC MONOGRAPH FINAL part335 Lil' Drug Store Products, Inc. BISMUTH SUBSALICYLATE 262 mg/1 66715-9724_b3602311-f85a-47ac-bb8e-b027da4dd192 66715-9724 HUMAN OTC DRUG Mucinex DM Guaifenesin and Dextromethorphan Hydrobromide TABLET ORAL 20100510 NDA NDA021620 Lil' Drug Store Products, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30; 600 mg/1; mg/1 66715-9726_ba250132-6df0-4dc6-ada4-7de82a1d55da 66715-9726 HUMAN OTC DRUG BAYER ASPIRIN TABLET ORAL 20090701 OTC MONOGRAPH FINAL part343 Lil' Drug Store Products, Inc. ASPIRIN 325 mg/1 66715-9727_fcdc55ad-2c1e-4217-8dc8-9dd590e5380a 66715-9727 HUMAN OTC DRUG Lil Drug Store Allergy Sinus Relief Acetaminophen, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride TABLET ORAL 20110208 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 66715-9728_345d093d-4896-4a6a-b077-7ef4c8d1ea62 66715-9728 HUMAN OTC DRUG Lil Drug Store Cold Relief Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20110203 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 66715-9730_7564789d-50d9-490e-b9fd-0d5c6ce49580 66715-9730 HUMAN OTC DRUG Lil Drug Store NoSnooze Caffeine TABLET ORAL 20110208 OTC MONOGRAPH FINAL part340 Lil' Drug Store Products, Inc. CAFFEINE 200 mg/1 66715-9732_34f3c557-db6f-4531-8254-8cc8b5111423 66715-9732 HUMAN OTC DRUG Claritin Antihistamine Loratadine TABLET ORAL 20041123 NDA NDA019658 Lil' Drug Store Products, Inc LORATADINE 10 mg/1 66715-9733_f944ec73-8742-404c-8b33-1f8c4fd27e95 66715-9733 HUMAN OTC DRUG Advil PM Ibuprofen and Diphenhydramine citrate TABLET, COATED ORAL 20100511 NDA NDA021394 Lil' Drug Store Products, Inc. DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 66715-9735_2cdd4508-98cd-4854-a421-3d1dac80b9ac 66715-9735 HUMAN OTC DRUG Alka-Seltzer Plus Aspirin, Chlorpheniramine Maleate, and Phenylephrine Bitartrate TABLET, EFFERVESCENT ORAL 20000101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 66715-9736_e2d5313a-77f3-4402-914c-c4ab0b904b1d 66715-9736 HUMAN OTC DRUG Zantac 150 Acid Reducer Ranitidine TABLET ORAL 20101101 NDA NDA021698 Lil' Drug Store Products, Inc RANITIDINE HYDROCHLORIDE 150 mg/1 66715-9737_791853b0-759b-495d-a119-5d9fe8fa6220 66715-9737 HUMAN OTC DRUG Lil Drug Store Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20110127 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc. ACETAMINOPHEN 500 mg/1 66715-9738_cad11b4d-82f6-4463-9f8f-cc72de52ea25 66715-9738 HUMAN OTC DRUG Lil Drug Store Headache Relief Extra Strength Acetaminophen, Aspirin, and Caffeine TABLET ORAL 20110127 ANDA ANDA075794 Lil' Drug Store Products, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 66715-9739_1a6017a9-2d67-40c9-9107-05b3a8949877 66715-9739 HUMAN OTC DRUG Lil Drug Store Ibuprofen Ibuprofen TABLET ORAL 20110127 ANDA ANDA075010 Lil' Drug Store Products, Inc. IBUPROFEN 200 mg/1 66715-9740_57fc2e5c-24d0-4e57-89df-bcecb2689fe5 66715-9740 HUMAN OTC DRUG Lil Drug Store Pain Relief All Day Naproxen Sodium TABLET ORAL 20110127 ANDA ANDA079096 Lil' Drug Store Products, Inc. NAPROXEN SODIUM 220 mg/1 66715-9741_42c786ab-ea6f-4d21-97b6-0f92bce76191 66715-9741 HUMAN OTC DRUG Advil Congestion Relief Ibuprofen and Phenylephrine Hydrochloride TABLET, COATED ORAL 20110501 NDA NDA022565 Lil' Drug Store Products, Inc IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 66715-9743_90ed04b8-019e-498b-bd62-987d8736705e 66715-9743 HUMAN OTC DRUG Lil Drug Store Nighttime Sleep-Aid Diphenhydramine Hydrochloride TABLET ORAL 20110602 OTC MONOGRAPH FINAL part338 Lil' Drug Store Products, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 66715-9744_4667b227-e261-47b6-9231-b7b9e1741b9d 66715-9744 HUMAN OTC DRUG Lil Drug Store Multi-Symptom Sinus Relief Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20110601 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 66715-9745_2b5dc9dd-0e2a-4cea-beff-51a4d7b7bed2 66715-9745 HUMAN OTC DRUG Midol Complete Acetaminophen, Caffeine, and Pyrilamine Maleate TABLET ORAL 20111201 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 66715-9747_9aca213a-6bc5-4353-9bc2-a7a837629f96 66715-9747 HUMAN OTC DRUG TYLENOL EXTRA STRENGTH Acetaminophen TABLET, COATED ORAL 20110809 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc. ACETAMINOPHEN 500 mg/1 66715-9752_bd3bf070-e91f-4660-8e8c-1df392154e80 66715-9752 HUMAN OTC DRUG Advil Liquigels Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120501 NDA NDA020402 Lil' Drug Store Products, Inc IBUPROFEN 200 mg/1 66715-9754_391abeec-6baf-408d-b227-5f8e5ea7d769 66715-9754 HUMAN OTC DRUG Lil Drug Store Anti-Diarrheal Loperamide Hydrochloride TABLET ORAL 20120901 ANDA ANDA075232 Lil' Drug Store Products, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 66715-9815_1ab56648-1186-4d1b-98d7-9462b489d3da 66715-9815 HUMAN OTC DRUG BC Cherry Aspirin and Caffeine POWDER ORAL 20140301 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc ASPIRIN; CAFFEINE 845; 65 mg/1; mg/1 66715-9823_c9674bc1-237e-4cbe-9df4-7f5984f0b9aa 66715-9823 HUMAN OTC DRUG 7-Select Pepto Bismol Bismuth Subsalicylate TABLET, CHEWABLE ORAL 20110801 OTC MONOGRAPH FINAL part335 Lil' Drug Store Products, Inc BISMUTH SUBSALICYLATE 262 mg/1 66715-9827_fcdc55ad-2c1e-4217-8dc8-9dd590e5380a 66715-9827 HUMAN OTC DRUG Lil Drug Store Allergy Sinus Relief Acetaminophen, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride TABLET ORAL 20110208 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 66715-9828_345d093d-4896-4a6a-b077-7ef4c8d1ea62 66715-9828 HUMAN OTC DRUG Lil Drug Store Cold Relief Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20110203 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 66715-9830_7564789d-50d9-490e-b9fd-0d5c6ce49580 66715-9830 HUMAN OTC DRUG Lil Drug Store NoSnooze Caffeine TABLET ORAL 20110208 OTC MONOGRAPH FINAL part340 Lil' Drug Store Products, Inc. CAFFEINE 200 mg/1 66715-9833_6bbcc644-080b-4529-8524-de14610b55aa 66715-9833 HUMAN OTC DRUG 7-Select Advil PM Ibuprofen and Diphenhydramine Citrate TABLET, COATED ORAL 20110601 NDA NDA021394 Lil' Drug Store Products, Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 66715-9837_791853b0-759b-495d-a119-5d9fe8fa6220 66715-9837 HUMAN OTC DRUG Lil Drug Store Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20110127 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc. ACETAMINOPHEN 500 mg/1 66715-9843_90ed04b8-019e-498b-bd62-987d8736705e 66715-9843 HUMAN OTC DRUG Lil Drug Store Nighttime Sleep-Aid Diphenhydramine Hydrochloride TABLET ORAL 20110602 OTC MONOGRAPH FINAL part338 Lil' Drug Store Products, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 66715-9844_4667b227-e261-47b6-9231-b7b9e1741b9d 66715-9844 HUMAN OTC DRUG Lil Drug Store Multi-Symptom Sinus Relief Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20110601 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 66733-948_63642894-aaa8-4e5b-97fd-3c44aeeedd8a 66733-948 HUMAN PRESCRIPTION DRUG ERBITUX cetuximab SOLUTION INTRAVENOUS 20040212 BLA BLA125084 ImClone LLC CETUXIMAB 2 mg/mL Epidermal Growth Factor Receptor Antagonist [EPC],HER1 Antagonists [MoA] 66733-958_63642894-aaa8-4e5b-97fd-3c44aeeedd8a 66733-958 HUMAN PRESCRIPTION DRUG ERBITUX cetuximab SOLUTION INTRAVENOUS 20071002 BLA BLA125084 ImClone LLC CETUXIMAB 2 mg/mL Epidermal Growth Factor Receptor Antagonist [EPC],HER1 Antagonists [MoA] 66738-701_667c3712-791e-4427-98b7-5eff292346af 66738-701 HUMAN OTC DRUG Pit Boss Antiperspirant and Deodorant Antiperspirant/Deodorant STICK TOPICAL 20121206 OTC MONOGRAPH FINAL part350 Jack Black L.L.C. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 25 g/100g 66758-004_02db44b0-7a66-4964-9df5-4d186c8fb155 66758-004 HUMAN PRESCRIPTION DRUG L-Cysteine Hydrochloride L-Cysteine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20081201 UNAPPROVED DRUG OTHER Sandoz Inc CYSTEINE HYDROCHLORIDE 50 mg/mL 66758-005_083366d6-0437-4ee0-90d4-440a5b5d03b5 66758-005 HUMAN PRESCRIPTION DRUG L-Cysteine Hydrochloride L-Cysteine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20081201 UNAPPROVED DRUG OTHER Sandoz Inc CYSTEINE HYDROCHLORIDE 50 mg/mL 66758-008_f953f018-d9da-404d-9615-5577155b3fdf 66758-008 HUMAN PRESCRIPTION DRUG Ephedrine Sulfate Ephedrine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20040326 UNAPPROVED DRUG OTHER Sandoz Inc EPHEDRINE SULFATE 50 mg/mL 66758-014_b82546c4-bd74-4475-84e7-e5ce0574a55a 66758-014 HUMAN PRESCRIPTION DRUG Papaverine Hydrochloride Papaverine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20081201 UNAPPROVED OTHER Ebewe Parenta Pharmaceuticals Inc PAPAVERINE HYDROCHLORIDE 30 mg/mL 66758-015_b82546c4-bd74-4475-84e7-e5ce0574a55a 66758-015 HUMAN PRESCRIPTION DRUG Papaverine Hydrochloride Papaverine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20081201 UNAPPROVED OTHER Ebewe Parenta Pharmaceuticals Inc PAPAVERINE HYDROCHLORIDE 30 mg/mL 66758-016_fa6aaa7c-d85d-496b-914d-aa07bafd7e79 66758-016 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050625 UNAPPROVED DRUG OTHER Sandoz Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 66758-017_fa6aaa7c-d85d-496b-914d-aa07bafd7e79 66758-017 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050625 UNAPPROVED DRUG OTHER Sandoz Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 66758-035_48c3201e-bf32-42bf-9696-03062d5fbbc8 66758-035 HUMAN PRESCRIPTION DRUG Granisetron Granisetron INJECTION INTRAVENOUS 20080630 ANDA ANDA078835 Sandoz Inc GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 66758-036_48c3201e-bf32-42bf-9696-03062d5fbbc8 66758-036 HUMAN PRESCRIPTION DRUG Granisetron Granisetron INJECTION INTRAVENOUS 20080630 ANDA ANDA078835 Sandoz Inc GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 66758-040_b4c82062-08eb-482e-ba9d-6423ad032a98 66758-040 HUMAN PRESCRIPTION DRUG Methotrexate Sodium Methotrexate Sodium INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20090601 ANDA ANDA090039 Sandoz Inc METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 66758-041_b4c82062-08eb-482e-ba9d-6423ad032a98 66758-041 HUMAN PRESCRIPTION DRUG Methotrexate Sodium Methotrexate Sodium INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20090601 ANDA ANDA090029 Sandoz Inc METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 66758-042_516afd6b-38ec-4819-9bb1-37606c0d6739 66758-042 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride Epirubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20091222 ANDA ANDA065339 Sandoz Inc EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 66758-043_68db34d0-9187-414a-b1d2-7418da85dac0 66758-043 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION INTRAVENOUS 20080102 ANDA ANDA078167 Sandoz Inc. PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 66758-044_19dd287f-9d5d-4742-913f-25afa34bf277 66758-044 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20080910 ANDA ANDA040772 Sandoz Inc FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 66758-045_5906f55a-6fed-43e0-bdd6-4635845427e0 66758-045 HUMAN PRESCRIPTION DRUG Vinorelbine tartrate Vinorelbine tartrate INJECTION, SOLUTION INTRAVENOUS 20080213 ANDA ANDA078408 Sandoz Inc. VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 66758-046_ff9d0403-be44-469d-9dfe-d2156094bf60 66758-046 HUMAN PRESCRIPTION DRUG Fludarabine Phosphate Fludarabine Phosphate INJECTION, SOLUTION INTRAVENOUS 20071012 NDA NDA022137 Sandoz Inc FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 66758-047_4ab1835d-95a1-4864-9739-d26fee1e4d8b 66758-047 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION, SOLUTION INTRAVENOUS 20100131 ANDA ANDA078280 Sandoz Inc CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 66758-048_88b91f04-681a-4158-ad7a-77be249a6689 66758-048 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20091130 ANDA ANDA090137 Sandoz Inc IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 66758-050_d2c1c731-9c3d-4b06-9b37-0938dae9bfc4 66758-050 HUMAN PRESCRIPTION DRUG Docetaxel docetaxel INJECTION, SOLUTION INTRAVENOUS 20110629 NDA NDA201525 Sandoz Inc DOCETAXEL 10 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 66758-051_6bc88223-4de9-4ff7-b59f-e479c1fce600 66758-051 HUMAN PRESCRIPTION DRUG Topotecan Topotecan INJECTION INTRAVENOUS 20110225 NDA NDA200199 Sandoz Inc TOPOTECAN HYDROCHLORIDE 1 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 66758-054_1b835751-d6a4-49b6-b0f8-23ab31b0d04e 66758-054 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20110502 ANDA ANDA091299 Sandoz Inc FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 66758-055_615d206a-b178-4ff4-b6c1-7e349099f3c7 66758-055 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride Idarubicin Hydrochloride INJECTION INTRAVENOUS 20110329 ANDA ANDA091293 Sandoz Inc IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 66758-110_f2b0dc7a-dc28-40d6-8261-41389ed1413e 66758-110 HUMAN PRESCRIPTION DRUG KLOR-CON potassium chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140901 NDA NDA019123 Sandoz Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 66758-120_8bf572d8-031a-4144-8b26-40e1aa103184 66758-120 HUMAN PRESCRIPTION DRUG KLOR-CON potassium chloride POWDER, FOR SOLUTION ORAL 20140901 UNAPPROVED DRUG OTHER Sandoz Inc. POTASSIUM CHLORIDE 20 meq/1.5g Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 66758-130_8bf572d8-031a-4144-8b26-40e1aa103184 66758-130 HUMAN PRESCRIPTION DRUG KLOR-CON/25 potassium chloride POWDER, FOR SOLUTION ORAL 20140901 UNAPPROVED DRUG OTHER Sandoz Inc. POTASSIUM CHLORIDE 25 meq/1.875g Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 66758-140_bf7893d6-6ead-4c63-b71d-2862fa8a6d52 66758-140 HUMAN PRESCRIPTION DRUG KLOR-CON/EF Potassium Bicarbonate TABLET, EFFERVESCENT ORAL 20140901 UNAPPROVED DRUG OTHER Sandoz Inc. POTASSIUM BICARBONATE 978 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 66758-160_f2b0dc7a-dc28-40d6-8261-41389ed1413e 66758-160 HUMAN PRESCRIPTION DRUG KLOR-CON potassium chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140901 NDA NDA019123 Sandoz Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 66758-170_5ef35497-03a1-497a-b86e-1ae441dc2349 66758-170 HUMAN PRESCRIPTION DRUG KLOR-CON M potassium chloride TABLET, EXTENDED RELEASE ORAL 20140901 ANDA ANDA074726 Sandoz Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 66758-180_5ef35497-03a1-497a-b86e-1ae441dc2349 66758-180 HUMAN PRESCRIPTION DRUG KLOR-CON M potassium chloride TABLET, EXTENDED RELEASE ORAL 20140901 ANDA ANDA074726 Sandoz Inc. POTASSIUM CHLORIDE 1125 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 66758-190_5ef35497-03a1-497a-b86e-1ae441dc2349 66758-190 HUMAN PRESCRIPTION DRUG KLOR-CON M potassium chloride TABLET, EXTENDED RELEASE ORAL 20140901 ANDA ANDA074726 Sandoz Inc. POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 66761-122_8d848ae9-7dfe-4273-b991-2b3f64f831d1 66761-122 HUMAN OTC DRUG Tiger Balm Muscle Rub Pain Relieving Methyl Salicylate, Menthol, and Camphor (Synthetic) CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 30; 50; 150 mg/g; mg/g; mg/g 66761-308_908ef81d-ab06-4115-816a-c819aca97918 66761-308 HUMAN OTC DRUG Tiger Balm Red Extra Strength Camphor (Synthetic) and Menthol OINTMENT TOPICAL 20050817 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. CAMPHOR (SYNTHETIC); MENTHOL 110; 100 mg/g; mg/g 66761-309_03084075-e885-4789-a9a7-4145e7a6ee6d 66761-309 HUMAN OTC DRUG Tiger Balm White Regular Strength Camphor (Synthetic) and Menthol OINTMENT TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. CAMPHOR (SYNTHETIC); MENTHOL 110; 80 mg/g; mg/g 66761-311_f707aa94-8516-43c5-9c3b-b07ce3485a86 66761-311 HUMAN OTC DRUG Kwan Loong Methyl salicylate and Menthol OIL TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. MENTHOL; METHYL SALICYLATE 160; 350 mg/mL; mg/mL 66761-315_b3f16e29-a7de-4c9f-915b-5723151c377b 66761-315 HUMAN OTC DRUG Tiger Balm Ultra Strength Camphor (Synthetic) and Menthol OINTMENT TOPICAL 20050817 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. CAMPHOR (SYNTHETIC); MENTHOL 110; 110 mg/g; mg/g 66761-321_e058d38b-55c7-49ca-878d-9471146c0749 66761-321 HUMAN OTC DRUG Tiger Balm Camphor (Synthetic) and Menthol PATCH TOPICAL 20070115 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. CAMPHOR (SYNTHETIC); MENTHOL 230; 70 mg/1; mg/1 66761-322_bf19f922-c685-4049-a91f-95604c133eec 66761-322 HUMAN OTC DRUG Tiger Balm Camphor (Synthetic), Menthol, and Capsicum PATCH TOPICAL 20011115 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. CAMPHOR (SYNTHETIC); CAPSICUM; MENTHOL 80; 16; 24 mg/1; mg/1; mg/1 66761-333_a7e08966-67b4-479b-88b4-bc689848c169 66761-333 HUMAN OTC DRUG Tiger Balm Methyl Salicylate and Menthol LINIMENT TOPICAL 20051208 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. MENTHOL; METHYL SALICYLATE 148.8; 260.4 mg/mL; mg/mL 66761-341_311e857e-2570-4005-a0a2-96709e2eb840 66761-341 HUMAN OTC DRUG Tiger Balm Neck and Shoulder Rub Camphor (Synthetic) and Menthol CREAM TOPICAL 20081024 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. CAMPHOR (SYNTHETIC); MENTHOL 11; 10 mg/g; mg/g 66761-710_bb0b4119-ddcf-4cb1-b97f-fdb3e0e90690 66761-710 HUMAN OTC DRUG Tiger Balm Ultra Thin Methyl Salicylate and Menthol PATCH TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. MENTHOL; METHYL SALICYLATE 60; 200 mg/1; mg/1 66774-1001_06ab05e1-e358-4cfe-b092-e5eacf629918 66774-1001 HUMAN OTC DRUG Blister Blaster Benzalkonium chloride LIQUID TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part333A Quadex Pharmaceuticals, LLC BENZALKONIUM CHLORIDE .12 g/100mL 66774-1003_4fc1e4bd-01d8-4675-9e2e-a4ff884bda11 66774-1003 HUMAN OTC DRUG Viroxyn Professional Use Benzalkonium chloride and Benzocaine LIQUID TOPICAL 20121022 OTC MONOGRAPH NOT FINAL part348 Quadex Pharmaceuticals LLC BENZALKONIUM CHLORIDE; BENZOCAINE 1.14; 65.775 mg/mL; mg/mL 66780-115_32b1c1a8-3a24-4b78-b78b-2d272f46a81d 66780-115 HUMAN PRESCRIPTION DRUG SymlinPen pramlintide acetate INJECTION SUBCUTANEOUS 20050316 NDA NDA021332 Amylin Pharmaceuticals, LLC PRAMLINTIDE ACETATE 1000 ug/mL Amylin Agonists [MoA],Amylin Analog [EPC] 66780-121_32b1c1a8-3a24-4b78-b78b-2d272f46a81d 66780-121 HUMAN PRESCRIPTION DRUG SymlinPen pramlintide acetate INJECTION SUBCUTANEOUS 20050316 NDA NDA021332 Amylin Pharmaceuticals, LLC PRAMLINTIDE ACETATE 1000 ug/mL Amylin Agonists [MoA],Amylin Analog [EPC] 66780-210_97c31596-6a6e-4bf6-9364-13872be40d99 66780-210 HUMAN PRESCRIPTION DRUG Byetta exenatide INJECTION SUBCUTANEOUS 20050428 NDA NDA021773 Amylin Pharmaceuticals, LLC EXENATIDE 250 ug/mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] 66780-212_97c31596-6a6e-4bf6-9364-13872be40d99 66780-212 HUMAN PRESCRIPTION DRUG Byetta exenatide INJECTION SUBCUTANEOUS 20050428 NDA NDA021773 Amylin Pharmaceuticals, LLC EXENATIDE 250 ug/mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] 66780-219_6d234cef-f3fd-4a28-918c-0b0c9549d54a 66780-219 HUMAN PRESCRIPTION DRUG BYDUREON exenatide KIT 20120127 NDA NDA022200 Amylin Pharmaceuticals, LLC 66780-226_6d234cef-f3fd-4a28-918c-0b0c9549d54a 66780-226 HUMAN PRESCRIPTION DRUG BYDUREON exenatide KIT 20120127 NDA NDA022200 Amylin Pharmaceuticals, LLC 66780-310_189c7038-2646-4dfe-b299-7d77e2e7718c 66780-310 HUMAN PRESCRIPTION DRUG MYALEPT Metreleptin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20140522 BLA BLA125390 Amylin Pharmaceuticals, LLC METRELEPTIN 11.3 mg/2.2mL Leptin Analog [EPC],Analogs/Derivatives [Chemical/Ingredient],Leptin [Chemical/Ingredient] 66794-011_4f7880f3-5710-4dcb-92fd-4f7e0119eabe 66794-011 HUMAN PRESCRIPTION DRUG Terrell Isoflurane INHALANT NASAL 20100228 ANDA ANDA074416 Piramal Critical Care Inc. ISOFLURANE 99.9 mL/100mL General Anesthesia [PE],General Anesthetic [EPC] 66794-012_1b95a1f2-09b5-49d2-819f-b390a24e9768 66794-012 HUMAN PRESCRIPTION DRUG Sojourn Sevoflurane INHALANT NASAL 20100413 ANDA ANDA077867 Piramal Critical Care Inc SEVOFLURANE 99.9 mL/100mL General Anesthesia [PE],General Anesthetic [EPC] 66794-015_952653bd-c595-4676-9285-135a365bdb4f 66794-015 HUMAN PRESCRIPTION DRUG Sevoflurane Sevoflurane INHALANT NASAL 20110715 ANDA ANDA077867 Piramal Critical Care Inc SEVOFLURANE 99.9 mL/100mL General Anesthesia [PE],General Anesthetic [EPC] 66794-017_23685d50-7218-476e-aeeb-9348da2218f2 66794-017 HUMAN PRESCRIPTION DRUG Isoflurane Isoflurane INHALANT NASAL 20111007 ANDA ANDA074502 Piramal Critical Care Inc ISOFLURANE 99.9 mL/100mL General Anesthesia [PE],General Anesthetic [EPC] 66794-019_830d6e61-eb4d-4b25-a370-6f1c1d663c9c 66794-019 HUMAN PRESCRIPTION DRUG Terrell Isoflurane LIQUID RESPIRATORY (INHALATION) 20120321 ANDA ANDA074502 Piramal Critical Care Inc ISOFLURANE 1 mL/mL General Anesthesia [PE],General Anesthetic [EPC] 66794-020_13c9c37a-0c3d-450a-a61e-d2796818b18f 66794-020 HUMAN PRESCRIPTION DRUG Isoflurane Isoflurane LIQUID NASAL 20131113 ANDA ANDA074416 Piramal Critical Care Inc ISOFLURANE 1 mL/mL General Anesthesia [PE],General Anesthetic [EPC] 66803-001_e981f8e3-5c82-4160-9c00-c1242346d63c 66803-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Georgia Oxygen & Home Health OXYGEN 99 L/100L 66828-0030_d56c24fb-196d-4775-b67f-13c5e41bd150 66828-0030 HUMAN PRESCRIPTION DRUG Gleevec imatinib mesylate TABLET ORAL 20010515 NDA NDA021588 Novartis Pharma Produktions GmbH IMATINIB MESYLATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 66831-123_b7144551-cebd-4345-b476-307289789f45 66831-123 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19860101 UNAPPROVED MEDICAL GAS Arroyo Medical Supply dba Zia Health Care OXYGEN 99 L/100L 66854-001_d5e0b1f7-aecb-40d6-b2ea-41257b43cc5f 66854-001 HUMAN OTC DRUG Spai-Sons Calendula/Marigold Calendula Officinalis Flower Extract CREAM TOPICAL 20040601 OTC MONOGRAPH FINAL part358H SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS CALENDULA OFFICINALIS FLOWER; SULFUR 20; .11 g/100g; g/100g 66854-002_4e7897cf-7e6f-4f68-bb1c-660f2ab94dd9 66854-002 HUMAN OTC DRUG FEIX BIOAZUFRE / BIOSULPHUR SULFUR SOAP TOPICAL 20060501 OTC MONOGRAPH NOT FINAL part358H SPAI-SONS PHAMACEUTICAL INTERNATIONAL COSMETICS SULFUR 2 g/100g 66854-003_63764ca7-1280-4fec-a562-b73eb70644b3 66854-003 HUMAN OTC DRUG GYNOX-SOFT BORIC ACID EMULSION TOPICAL 20120630 UNAPPROVED DRUG OTHER SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS BORIC ACID 7 mg/100mL 66854-004_232823a8-d199-498c-98b3-15e8ad88ee2f 66854-004 HUMAN PRESCRIPTION DRUG DERMAPROT TRICLOTREX-B TRICLOSAN LIQUID TOPICAL 20120830 OTC MONOGRAPH FINAL part333E SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS TRICLOSAN .3 mg/100mL 66854-006_2cab6659-fb21-4d52-98bc-366ddf39ee6a 66854-006 HUMAN OTC DRUG SPAI-SONS FLOOP C ALUMINUM CHLOROHYDRATE CREAM TOPICAL 20090901 OTC MONOGRAPH FINAL part350 SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS ALUMINUM CHLOROHYDRATE 28 g/100g 66854-007_314f1ebc-353d-413e-beff-ddf3336e051a 66854-007 HUMAN PRESCRIPTION DRUG SPAI-SONS PROLAC-VIT BIOTIN LIQUID TOPICAL 20120806 UNAPPROVED DRUG OTHER SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS BIOTIN .01 mg/100mL 66854-008_85a6c379-b149-49e9-a2a9-bf2c1758b033 66854-008 HUMAN OTC DRUG SPAI-SONS FLOOP R ALUMINUM CHLOROHYDRATE EMULSION TOPICAL 20071101 OTC MONOGRAPH FINAL part350 SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS ALUMINUM CHLOROHYDRATE 280 mL/1000mL 66854-009_ad451d2e-292a-42db-8b48-0a98e11637da 66854-009 HUMAN OTC DRUG EOUX DEODORANT ALUMINUM CHLOROHYDRATE EMULSION TOPICAL 20120531 OTC MONOGRAPH FINAL part350 SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS ALUMINUM CHLOROHYDRATE 280 mL/1000mL 66854-010_e6c652d5-fd27-4b09-aa3f-262fa3076532 66854-010 HUMAN OTC DRUG BIONA-VIT CONTROLS AND PREVENTS HAIR LOSS BIOTIN LIQUID TOPICAL 20120630 UNAPPROVED DRUG OTHER SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS BIOTIN .01 mL/100mL 66854-011_79484ac9-ea4f-438a-af6f-b58bc8c5e118 66854-011 HUMAN OTC DRUG SPAI-SONS PROCAPELL BIOTIN LIQUID TOPICAL 20120630 UNAPPROVED DRUG OTHER SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS BIOTIN .01 mL/100mL 66854-013_02b48851-bdcc-4a02-8168-35a65d768f73 66854-013 HUMAN OTC DRUG DERMAPROT TRICLOTREX-B TRICLOSAN LIQUID TOPICAL 20120531 OTC MONOGRAPH FINAL part333E SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS TRICLOSAN .3 mL/100mL 66854-015_73093bfc-143f-4c62-a590-29cba99d0ff5 66854-015 HUMAN OTC DRUG TRICLOTREX-B ANTIBACTERIAL TRICLOSAN GEL TOPICAL 20120416 OTC MONOGRAPH FINAL part333E SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS TRICLOSAN .3 g/100g 66854-016_7d5b0d07-c818-43eb-991e-9f8db5a36101 66854-016 HUMAN OTC DRUG TRICLOTREX-B ANTIBACTERIAL (NEUTRAL) TRICLOSAN GEL TOPICAL 20120416 OTC MONOGRAPH FINAL part333E SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS TRICLOSAN .3 g/100g 66854-017_0e71594b-a004-44cb-a8ae-f76ee1b1db4b 66854-017 HUMAN OTC DRUG SPAI-SONS ALKALINE DRY-DANDRUFF PYRITHIONE ZINC SHAMPOO TOPICAL 20120630 OTC MONOGRAPH FINAL part358H SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS PYRITHIONE ZINC 1 mL/100mL 66854-018_58da040b-6dcb-47d4-8617-b5eae34c1718 66854-018 HUMAN OTC DRUG SPAI-SONS FINE TALCUM TALC POWDER TOPICAL 20120630 OTC MONOGRAPH NOT FINAL part347 SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS TALC; ZINC OXIDE 81; 5 g/100g; g/100g 66854-020_69fcc2d1-dcb1-4a73-8a3a-4f8e411620b2 66854-020 HUMAN OTC DRUG TK-NAX BIOTIN LIQUID TOPICAL 20120630 UNAPPROVED DRUG OTHER SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS BIOTIN .01 mL/100mL 66854-021_e8a9a451-b8b7-4ed3-8ca9-26ac2aee1bd1 66854-021 HUMAN OTC DRUG SPAI-SONS ACID ANTI-DANDRUFF SULFUR SHAMPOO TOPICAL 20120630 OTC MONOGRAPH FINAL part358H SPAI-SONS PHARAMCUETICAL INTERNATIONAL COSMETICS SULFUR .4 mL/100mL 66854-023_c18084e3-4a9d-4622-8d28-32fc10c29656 66854-023 HUMAN OTC DRUG SPAI-SONS MARIGOLD OILY SKIN SULFUR CREAM TOPICAL 20120630 OTC MONOGRAPH FINAL part358H SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS SULFUR .1 g/100g 66854-024_08e18a05-4766-4a2a-9c3f-372a4a274853 66854-024 HUMAN OTC DRUG FEIX FACIAL SULFUR LIQUID TOPICAL 20120630 OTC MONOGRAPH FINAL part358H SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS DIPYRITHIONE; SULFUR .5; .2 mL/100mL; mL/100mL 66854-025_469199f3-6194-4eda-8351-c99130f06299 66854-025 HUMAN OTC DRUG SPA SKILHA HELIOPROT AB SPF 40 BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE CREAM TOPICAL 20120630 OTC MONOGRAPH FINAL part352 SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS AVOBENZONE; BEMOTRIZINOL; OCTINOXATE; TITANIUM DIOXIDE 4; 1.5; 7.5; 2 g/100g; g/100g; g/100g; g/100g 66854-026_3aa210bd-65ec-411f-9328-2dc7ae4cd504 66854-026 HUMAN OTC DRUG DERMAPROT HELIOPROT AB SPF 30 OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE LOTION TOPICAL 20120630 OTC MONOGRAPH FINAL part352 SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS AVOBENZONE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 2.5; 7.5; 1.5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL 66869-104_b5e8d6e7-8ec4-4f72-9a54-ee4d69858eee 66869-104 HUMAN PRESCRIPTION DRUG Livalo pitavastatin calcium TABLET, FILM COATED ORAL 20100515 NDA NDA022363 Kowa Pharmaceuticals America, Inc. PITAVASTATIN CALCIUM 1.045 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66869-137_7aebd437-8796-4e28-880b-790b8e00ffff 66869-137 HUMAN PRESCRIPTION DRUG LIPOFEN fenofibrate CAPSULE ORAL 20071001 NDA NDA021612 Kowa Pharmaceuticals America Inc. FENOFIBRATE 50 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 66869-147_7aebd437-8796-4e28-880b-790b8e00ffff 66869-147 HUMAN PRESCRIPTION DRUG LIPOFEN fenofibrate CAPSULE ORAL 20071001 NDA NDA021612 Kowa Pharmaceuticals America Inc. FENOFIBRATE 150 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 66869-204_b5e8d6e7-8ec4-4f72-9a54-ee4d69858eee 66869-204 HUMAN PRESCRIPTION DRUG Livalo pitavastatin calcium TABLET, FILM COATED ORAL 20100515 NDA NDA022363 Kowa Pharmaceuticals America, Inc. PITAVASTATIN CALCIUM 2.09 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66869-404_b5e8d6e7-8ec4-4f72-9a54-ee4d69858eee 66869-404 HUMAN PRESCRIPTION DRUG Livalo pitavastatin calcium TABLET, FILM COATED ORAL 20100515 NDA NDA022363 Kowa Pharmaceuticals America, Inc. PITAVASTATIN CALCIUM 4.18 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 66887-001_938c29c0-fae8-11e3-a3ac-0800200c9a66 66887-001 HUMAN PRESCRIPTION DRUG Testim testosterone GEL TRANSDERMAL 20021031 NDA NDA021454 Auxilium Pharmaceuticals, Inc. TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 66887-003_aaa32fb5-a294-4b27-904c-fbbcc05bdfd9 66887-003 HUMAN PRESCRIPTION DRUG XIAFLEX collagenase clostridium histolyticum KIT 20100222 BLA BLA125338 Auxilium Pharmaceuticals, Inc. 66887-004_4c1b1129-f5b5-4d39-9c2a-50d34c059edc 66887-004 HUMAN PRESCRIPTION DRUG Testopel testosterone PELLET SUBCUTANEOUS 20141031 ANDA ANDA080911 Auxilium Pharmaceuticals, Inc. TESTOSTERONE 75 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 66887-005_30101891-99b7-4d60-91e0-27656b0b9d61 66887-005 HUMAN PRESCRIPTION DRUG Dilatrate SR isosorbide dinitrate CAPSULE ORAL 20141024 NDA NDA019790 Auxilium Pharmaceuticals, Inc. ISOSORBIDE DINITRATE 40 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 66894-0000_b0a72b13-14a5-4086-a05c-6c9a515374ce 66894-0000 HUMAN OTC DRUG Country Gent SODIUM FLUORIDE POWDER, DENTIFRICE DENTAL 20120101 OTC MONOGRAPH FINAL part355 Heavenly Harvest, Inc. SODIUM FLUORIDE 1.88 mg/g 66897-001_8e9b32da-635b-450a-b533-189d2643d16a 66897-001 HUMAN OTC DRUG Wong To Yick External Analgesic Camphor Menthol Methyl Salicylate OIL TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part348 Wicsun Trading Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 1; 1.6; 5 mL/10mL; mL/10mL; mL/10mL 66897-002_c53860a3-0adc-4741-80ef-21e6470466ee 66897-002 HUMAN OTC DRUG Easy Menthol PATCH TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 Wicsun Trading MENTHOL 4 g/1 66897-003_2ddbd651-6eff-4b7e-a4f9-c6c519dcc833 66897-003 HUMAN OTC DRUG Herbalgy Camphor Menthol Methyl Salicylate OIL TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part348 Wicsun Trading CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 10; 16; 31.5 mL/100mL; mL/100mL; mL/100mL 66898-100_efcea474-f352-4b6f-8859-f9faece1f41f 66898-100 HUMAN OTC DRUG Herbalgy Camphor Menthol Methyl Salicylate OIL TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part348 Herbalgy Pharmaceutical Limited CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 10; 16; 31.5 mL/100mL; mL/100mL; mL/100mL 66902-000_63543250-0b90-4d14-98a1-3869738d2822 66902-000 HUMAN OTC DRUG Fast Freeze CAMPHOR (NATURAL), Menthol GEL TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part348 Natural Essentials Inc. CAMPHOR (NATURAL); MENTHOL 2; 35 mg/g; mg/g 66902-001_48c1d301-036a-4610-b82c-555aef7e382d 66902-001 HUMAN OTC DRUG Fast Freeze CAMPHOR (NATURAL), MENTHOL SPRAY TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part348 Natural Essentials Inc. CAMPHOR (NATURAL); MENTHOL 2; 100 mg/g; mg/g 66902-015_a002aea7-72b8-4e17-ab97-fbcd04967874 66902-015 HUMAN OTC DRUG Fast Freeze MENTHOL SPRAY TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Natural Essentials Inc. MENTHOL 100 mg/g 66902-016_f78e1578-1fb0-4096-b299-64d661f911a9 66902-016 HUMAN OTC DRUG Fast Freeze Menthol GEL TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Natural Essentials Inc. MENTHOL 35 mg/g 66902-228_0a8f4510-8190-412d-90bc-d74df8cf65b9 66902-228 HUMAN OTC DRUG ZIMS ADVANCED CRACK CREME WITH HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 NATURAL ESSENTIALS, INC. HYDROCORTISONE 10 mg/L 66902-229_517b8c41-6282-48da-a136-d6e13464f26a 66902-229 HUMAN OTC DRUG ZIMS ADVANCED HYDROCORTISONE CONTINUOUS WITH ORGANIC ARNICA AND ALOE HYDROCORTISONE SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 NATURAL ESSENTIALS, INC. HYDROCORTISONE 10 g/L 66902-700_afec96f0-c8b9-4a16-98e4-d4820590b4cb 66902-700 HUMAN OTC DRUG ZIMS ARNICA MAX MENTHOL GEL TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 NATURAL ESSENTIALS, INC. MENTHOL 20 g/L 66902-800_a506d6a5-03e8-4a45-a7c3-32387aead9da 66902-800 HUMAN OTC DRUG ZIMS ADVANCED ACEMANNAN AND ARNICA ALLANTOIN GEL TOPICAL 20140101 OTC MONOGRAPH FINAL part347 NATURAL ESSENTIALS, INC. ALLANTOIN 5.5 g/L 66908-053_4af4e49c-7792-42fc-a33b-55eb38948c28 66908-053 HUMAN OTC DRUG ProFormance Series Antibacterial Triclosan LIQUID TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Pro-Link, Inc. TRICLOSAN .3 mL/100mL 66908-106_44a94ac1-9eef-4b78-8064-3c27f6ec0f13 66908-106 HUMAN OTC DRUG ProFormance Series Foam Non-Alcohol Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Pro-Link, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL 66908-107_987b5df0-f88f-4d4b-af0b-19322ee90618 66908-107 HUMAN OTC DRUG ProFormance Series Foam Alcohol Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Pro-Link, Inc. ALCOHOL 72 mL/100mL 66908-532_3b1cffd1-cee3-4874-85fb-dd6d1c88f4f1 66908-532 HUMAN OTC DRUG Proformance Antibacterial Triclosan LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333A Pro-Link, Inc. TRICLOSAN .3 mg/100mL 66908-700_61103ae7-7cfa-4d03-ba29-277eb248af68 66908-700 HUMAN OTC DRUG Proformance Foam Alcohol Sanitizer Ethyl Alcohol LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E Pro-Link, Inc. ALCOHOL 70 mL/100mL 66915-122_8ffe1f7a-f11a-4f61-91b1-7a00163c6dbd 66915-122 HUMAN OTC DRUG Apres Peel Soothing Balm Hydrocortisone CREAM TOPICAL 20110830 OTC MONOGRAPH NOT FINAL part348 CoValence, Inc. HYDROCORTISONE .05 mg/g 66915-300_0476ef1e-5392-2361-e054-00144ff8d46c 66915-300 HUMAN OTC DRUG Diaper Rash Zinc Oxide OINTMENT TOPICAL 20141002 OTC MONOGRAPH FINAL part347 CoValence, Inc. ZINC OXIDE .1 g/g 66915-301_044a84cf-ec8c-5e5e-e054-00144ff8d46c 66915-301 HUMAN OTC DRUG Stiptik Ferric Subsulfate SOLUTION TOPICAL 20141014 UNAPPROVED DRUG OTHER CoValence, Inc. FERRIC SUBSULFATE 1 g/g 66915-413_f6cafef6-e4ff-43f0-8c7e-0c5324747832 66915-413 HUMAN OTC DRUG Superlightener Hydroquinone GEL TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part358A CoValence Inc HYDROQUINONE 20 mg/g 66915-414_584b3231-9a88-458b-91df-99740e0f53e3 66915-414 HUMAN OTC DRUG gloTriple Action Serum Hydroquinone GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part358A CoValence Inc. HYDROQUINONE 20 mg/g 66915-436_5a1e61d7-b626-4fde-8be3-e716eb29a008 66915-436 HUMAN OTC DRUG Magic Marker Benzoyl Peroxide GEL TOPICAL 20100809 OTC MONOGRAPH FINAL part333D CoValence Inc. BENZOYL PEROXIDE 52.5 mg/g 66915-450_66735ebf-3513-4536-a897-c45332bdedcd 66915-450 HUMAN OTC DRUG Sulfur Cleanser Colloidal Sulfur 3% LIQUID TOPICAL 20131213 OTC MONOGRAPH FINAL part333D CoValence, Inc. SULFUR .03 g/g 66915-531_77a8eb20-9461-43ac-872e-11c3259a2167 66915-531 HUMAN OTC DRUG Refuge HC Hydrocortisone CREAM TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part348 CoValence Inc. HYDROCORTISONE .01 mg/g 66915-602_dd4e277a-6287-4c9a-9e94-cfe7952c8c89 66915-602 HUMAN OTC DRUG Sol Protect Zinc Oxide CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 CoValence, Inc. ZINC OXIDE .0702 mg/g 66915-604_8e9938c1-6190-4eeb-a607-8a7427df491b 66915-604 HUMAN OTC DRUG Natural SPF 28 Zinc Oxide 11.6%, Titanium Dioxide 0.67% CREAM TOPICAL 20131202 OTC MONOGRAPH FINAL part352 CoValence, Inc. TITANIUM DIOXIDE; ZINC OXIDE .0067; .116 g/g; g/g 66915-605_f45e2037-c767-4e52-9cc9-9402c132208b 66915-605 HUMAN OTC DRUG Day Cream SPF 30 Ethylhexyl Methoxycinnamate 7.5%, Benzophenone-3 6%, Ethylhexyl Salicylate 5%, Butyl Methoxydibenzoylmethane 1% CREAM TOPICAL 20130722 OTC MONOGRAPH FINAL part352 CoValence, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE .01; .075; .05; .06 g/g; g/g; g/g; g/g 66915-608_019d3983-de6f-4e2b-9d42-50df6876c8ce 66915-608 HUMAN OTC DRUG SPF 20 Zinc Oxide 15% CREAM TOPICAL 20131218 OTC MONOGRAPH FINAL part352 CoValence, Inc. ZINC OXIDE .15 g/g 66915-610_f72edd44-1b20-4c0a-8b45-6488e9c85fd7 66915-610 HUMAN OTC DRUG Elite Natural SPF 30 Zinc Oxide CREAM TOPICAL 20110831 OTC MONOGRAPH FINAL part352 CoValence, Inc. ZINC OXIDE .135 mg/g 66915-611_8ea410a3-0ef1-4567-b367-390626c5e1fc 66915-611 HUMAN OTC DRUG Daytime Defense SPF 30 ZINC OXIDE CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 CoValence, Inc. ZINC OXIDE .135 mg/g 66915-612_f0bc18fc-8d95-4724-8def-623049e5b804 66915-612 HUMAN OTC DRUG DNA Prime Natural SPF 45 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20140729 OTC MONOGRAPH FINAL part352 CoValence, Inc TITANIUM DIOXIDE; ZINC OXIDE .02; .225 mg/g; mg/g 66915-613_1ad1aed5-c455-4510-b419-3ca2063817a6 66915-613 HUMAN OTC DRUG Unscented SPF 17 Zinc Oxide 7% CREAM TOPICAL 20130812 OTC MONOGRAPH FINAL part352 CoValence, Inc. ZINC OXIDE .07 g/g 66915-619_066932af-b4e9-6771-e054-00144ff8d46c 66915-619 HUMAN OTC DRUG Natural SPF 28 Soy Free Zinc Oxide 11.6%, Titanium Dioxide 0.67% CREAM TOPICAL 20141001 OTC MONOGRAPH FINAL part352 CoValence, Inc. TITANIUM DIOXIDE; ZINC OXIDE .0067; .116 g/g; g/g 66923-406_92842690-217a-4066-87e0-2204a474a932 66923-406 HUMAN OTC DRUG Abridge Cold Sore Treatment Benzalkonium Chloride CREAM TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333A Ranir LLC BENZALKONIUM CHLORIDE 1.3 mg/g 66923-407_7ee416e0-d9e0-42b5-a3c7-c59c8c1813af 66923-407 HUMAN OTC DRUG Abridge Cold Sore Treatment Camphor CREAM TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Ranir LLC BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g 66944-001_af841143-97c4-4b26-87c3-bcf4b79042a3 66944-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020130 UNAPPROVED MEDICAL GAS Halifax Medical Equipment OXYGEN 99 L/100L 66949-052_6ec1b2f6-9bbd-40d6-8fd5-1ec5b8de2075 66949-052 HUMAN OTC DRUG Zep Professional Mild Antimicrobial Hand Cleaner Triclosan LIQUID TOPICAL 20091005 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL 66949-109_8264d85f-6ddc-46f9-995b-a0fd7c9810e2 66949-109 HUMAN OTC DRUG Zep Professional Alcohol Hand Sanitizing Ethanol LIQUID TOPICAL 20090407 OTC MONOGRAPH NOT FINAL part333A Zep Inc. ALCOHOL 6 mL/10mL 66949-112_2f2e9c05-a945-42ff-b220-8414b2e97070 66949-112 HUMAN OTC DRUG Zep Professional E-2 Hand Cleaner Benzalkonium Chloride LIQUID TOPICAL 20090407 OTC MONOGRAPH NOT FINAL part333A Zep Inc. BENZALKONIUM CHLORIDE .013 g/10mL 66949-206_cf0c2cdb-09aa-4f6e-bc65-5d4f60baa665 66949-206 HUMAN OTC DRUG Zep Professional Tranquil Meadows Triclosan LIQUID TOPICAL 20091005 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL 66949-207_b9bbc692-a610-4457-ab1e-017fada46897 66949-207 HUMAN OTC DRUG Zep Professional Z-Verdant Foaming Triclosan LIQUID TOPICAL 20090608 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL 66949-210_0ba7caaf-35b1-4923-8321-3d0c8bd777e5 66949-210 HUMAN OTC DRUG Zep Professional Healthcare Worker Triclosan LIQUID TOPICAL 20091005 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL 66949-246_f1fc53fb-1aac-44fb-8bdb-3dc3f17493d6 66949-246 HUMAN OTC DRUG Zep Instant Hand Sanitizer Ethanol LIQUID TOPICAL 20040129 OTC MONOGRAPH NOT FINAL part333A Zep Inc. ALCOHOL 6 mL/10mL 66949-248_6ae468cc-0284-4d92-99f6-dd3499d37966 66949-248 HUMAN OTC DRUG Zep Non Alcohol Foam Sanitizer Benzethonium Chloride LIQUID TOPICAL 20110714 OTC MONOGRAPH NOT FINAL part333E Zep, Inc BENZETHONIUM CHLORIDE .02 g/10mL 66949-252_bb1faeee-6806-416c-9a1b-5ea77802bcd7 66949-252 HUMAN OTC DRUG Zep Anti-Bacterial Foaming Hand Cleaner Triclosan LIQUID TOPICAL 20110714 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .1 g/100mL 66949-271_7f673310-29a7-4a17-be40-b273a710041a 66949-271 HUMAN OTC DRUG Zep E-2 Foaming Sanitizing Hand Cleaner Chloroxylenol LIQUID TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part333E Zep Inc. CHLOROXYLENOL .3 g/10mL 66949-277_d2430986-027f-4f0c-bebd-269445e063ab 66949-277 HUMAN OTC DRUG Zep Mango Foaming Triclosan LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL 66949-339_1ed9f19c-0906-4577-bf3f-703bafa0cdbb 66949-339 HUMAN OTC DRUG Zep Commercial Antibacterial Pear Triclosan LIQUID TOPICAL 20060407 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL 66949-357_cc3e73bf-b673-4ff6-a7d1-9f736b39f1ef 66949-357 HUMAN OTC DRUG Zep Alcohol Sanitizer Ethanol LIQUID TOPICAL 20000807 OTC MONOGRAPH NOT FINAL part333A Zep Inc. ALCOHOL 6.2 mL/10mL 66949-517_712be378-0853-4741-a482-d4b855886286 66949-517 HUMAN OTC DRUG Zep Provisions Pot and Pan Premium Triclosan LIQUID TOPICAL 20080124 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL 66949-601_60ec5a69-80ea-4fb2-b584-4d73809e0326 66949-601 HUMAN OTC DRUG Zep Aspen Triclosan LIQUID TOPICAL 20020314 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL 66949-607_ba74e96a-ccff-4eb9-b014-d25e1da6a79c 66949-607 HUMAN OTC DRUG Zep Provisions Pot and Pan Premium FF Triclosan LIQUID TOPICAL 20080124 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL 66949-769_95fb1d24-8022-4d91-8e32-70a55b27d5c3 66949-769 HUMAN OTC DRUG Zep Blue Sky Foaming Triclosan LIQUID TOPICAL 20080714 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL 66949-874_08f4df49-8c00-4485-ab85-4f59bf11e89f 66949-874 HUMAN OTC DRUG Zep Mango Foaming Triclosan LIQUID TOPICAL 20030916 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL 66949-875_7dd3e18b-b67a-487e-8ab6-b34c8139c168 66949-875 HUMAN OTC DRUG Zep Pear Anti-Bacterial Triclosan LIQUID TOPICAL 20030311 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL 66949-878_f1fc53fb-1aac-44fb-8bdb-3dc3f17493d6 66949-878 HUMAN OTC DRUG Zep Instant Hand Sanitizer Ethanol LIQUID TOPICAL 20040129 OTC MONOGRAPH NOT FINAL part333A Zep Inc. ALCOHOL 6 mL/10mL 66949-880_6ae468cc-0284-4d92-99f6-dd3499d37966 66949-880 HUMAN OTC DRUG Zep Foam San Benzethonium Chloride LIQUID TOPICAL 20030318 OTC MONOGRAPH NOT FINAL part333E Zep, Inc BENZETHONIUM CHLORIDE .02 g/10mL 66949-898_d45a1236-2234-4282-a7ed-674e8ed33de2 66949-898 HUMAN OTC DRUG Zep Cherry Creme Triclosan LIQUID TOPICAL 20030226 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL 66949-900_cc3e73bf-b673-4ff6-a7d1-9f736b39f1ef 66949-900 HUMAN OTC DRUG Zep Alcohol Sanitizer Ethanol LIQUID TOPICAL 20000807 OTC MONOGRAPH NOT FINAL part333A Zep Inc. ALCOHOL 6.2 mL/10mL 66949-901_c3440c82-8ade-4be0-8988-19f4b47af380 66949-901 HUMAN OTC DRUG Zep FS Antimicrobial Hand Cleaner Benzalkonium Chloride LIQUID TOPICAL 19930226 OTC MONOGRAPH NOT FINAL part333A Zep Inc. BENZALKONIUM CHLORIDE .013 g/10mL 66949-908_f1fc53fb-1aac-44fb-8bdb-3dc3f17493d6 66949-908 HUMAN OTC DRUG Zep Instant Hand Sanitizer Ethanol LIQUID TOPICAL 20040129 OTC MONOGRAPH NOT FINAL part333A Zep Inc. ALCOHOL 6 mL/10mL 66949-920_78e870ed-b98e-4ad4-b868-2fdf602f9a19 66949-920 HUMAN OTC DRUG Zep E-2 Hand Sanitizing Cleaner Chloroxylenol LIQUID TOPICAL 19880615 OTC MONOGRAPH NOT FINAL part333E Zep Inc. CHLOROXYLENOL .3 g/10mL 66949-923_7a353229-49b2-4638-aef7-197b7db4246f 66949-923 HUMAN OTC DRUG Zep Applaud Hand Cleaner Triclosan SOAP TOPICAL 20030226 OTC MONOGRAPH NOT FINAL part333A Zep Inc. CHLOROXYLENOL; TRICLOSAN .02; .02 g/10mL; g/10mL 66949-928_bca4e486-38ea-4527-8a8e-0af666a324df 66949-928 HUMAN OTC DRUG Zepaseptic Chloroxylenol LIQUID TOPICAL 19890420 OTC MONOGRAPH NOT FINAL part333E Zep Inc. CHLOROXYLENOL .3 g/10mL 66949-939_ad530c4e-7fde-4a8c-bedd-adb2cb70975d 66949-939 HUMAN OTC DRUG Zep Round One Hand Cleaner Chloroxylenol LIQUID TOPICAL 19880615 OTC MONOGRAPH NOT FINAL part333A Zep Inc. CHLOROXYLENOL .04 g/10L 66949-947_913d39c9-e8a9-43e3-b953-0d6c2c9cbbaa 66949-947 HUMAN OTC DRUG Zep Tranquil Meadows Triclosan LIQUID TOPICAL 20080124 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL 66949-994_7f673310-29a7-4a17-be40-b273a710041a 66949-994 HUMAN OTC DRUG Zep E-2 Foaming Sanitizing Hand Cleaner Chloroxylenol LIQUID TOPICAL 20000619 OTC MONOGRAPH NOT FINAL part333E Zep Inc. CHLOROXYLENOL .3 g/10mL 66949-996_f086405e-1660-44a2-b73e-a0fa57a64168 66949-996 HUMAN OTC DRUG Zep FS Antimicrobial Foaming Hand Cleaner Benzalkonium Chloride LIQUID TOPICAL 20060412 OTC MONOGRAPH NOT FINAL part333A Zep Inc. BENZALKONIUM CHLORIDE .0013 g/mL 66949-999_a9bd0c7c-bddf-4e50-a100-e5b16853da41 66949-999 HUMAN OTC DRUG Zep Acclaim Triclosan LIQUID TOPICAL 19950329 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL 66961-100_6a589a08-58e4-462b-85ce-8ae4b59ac5b9 66961-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020212 UNAPPROVED MEDICAL GAS Victor Welding Supply Company OXYGEN 992 mL/L 66961-120_9af4bc08-5f3e-4844-ae18-44cfd85211db 66961-120 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20020212 UNAPPROVED MEDICAL GAS Victor Welding Supply Company NITROGEN 992 mL/L 66966-0001_8d39dce2-67af-4c33-93e3-d8beffaca08e 66966-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020103 UNAPPROVED MEDICAL GAS Riverside Health Equipment OXYGEN 99 L/100L 66969-6001_739df1e9-10d8-429d-ba22-a98fa862b6d8 66969-6001 HUMAN OTC DRUG Buenos Dias de Personna original Eucalyptol , Menthol, Methyl Salicylate ,Thymol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL 66969-6002_4499bc3c-b193-4581-bea3-3128ae4c63ca 66969-6002 HUMAN OTC DRUG Buenos Dias de Personna mint Eucalyptol, Menthol,Methyl Salicylate, Thymol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL 66969-6003_d8d0b131-f60e-426c-b7e6-b8044ddbb35b 66969-6003 HUMAN OTC DRUG Buenos Dias de Personna cool mint Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL 66969-6012_a861cd9a-2d37-4861-8270-d8c30bb91e7c 66969-6012 HUMAN OTC DRUG Oral Dent Amber Eucalyptol ,Thymol, Methyl Salicylate, Menthol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetic Limited EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL 66969-6013_42347a25-20e2-4347-ac47-8f0d163b3c6e 66969-6013 HUMAN OTC DRUG Oral Dent Fresh Mint Eucalyptol, Thymol, Methyl Salicylate, Menthol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL 66969-6014_cc3b68a6-d2d9-447d-8015-d740aa16bd12 66969-6014 HUMAN OTC DRUG ORAL-DENT Blue Mint Eucalyptol, Thymol, Methyl Salicylate, Menthol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetic Limited EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL 66969-6015_2faeb6db-8f12-448e-b7ad-19b86f506192 66969-6015 HUMAN OTC DRUG Oral Dent Citrus Eucalyptol, Thymol, Methyl Salicylate, Menthol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetic Limited EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL 66969-6020_ca0ba7c9-eea2-4ee5-aea6-fa573db38e16 66969-6020 HUMAN OTC DRUG Oral Dent Amber Eucalyptol, Thymol, Methyl Salicylate, Menthol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL 66969-6021_7f775c60-b6fc-4dae-9a29-bc6b0e4a5ebe 66969-6021 HUMAN OTC DRUG Oral Dent Fresh Mint Eucalyptol, Thymol, Methyl Salicylate , Menthol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL 66969-6022_00127bd3-c4a8-49d7-ba32-beeab6b018b5 66969-6022 HUMAN OTC DRUG Oral Dent Blue Mint Eucalyptol, Thymol, Methyl Salicylate, Menthol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL 66969-6023_980e99ae-8be7-48fa-af5f-33972ee3b795 66969-6023 HUMAN OTC DRUG Oral Dent Citrus Eucalyptol, Thymol, Methyl Salicylate, Menthol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL 66969-6024_68679312-84e8-4e5d-aaca-13625ba89e1d 66969-6024 HUMAN OTC DRUG Buenos Dias de Personna citrus flavour Eucalyptol , Menthol , Methyl Salicylate, Thymol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL 66975-050_a4931840-0bfb-4e7e-b024-951babe93a04 66975-050 HUMAN PRESCRIPTION DRUG Iris 60 Second APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Benco Dental SODIUM FLUORIDE 5.6 g/454g 66975-051_48c4827c-17e5-435b-907d-34e0b40e68a3 66975-051 HUMAN PRESCRIPTION DRUG Iris 60 Second APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Benco Dental SODIUM FLUORIDE 5.6 g/454g 66975-052_8a7bf830-c9b4-4087-8743-045bd216e9eb 66975-052 HUMAN PRESCRIPTION DRUG Iris 60 Second APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Benco Dental SODIUM FLUORIDE 5.6 g/454g 66975-053_d686d3f5-1115-49a5-b2fb-effd0474f55e 66975-053 HUMAN PRESCRIPTION DRUG Iris 60 Second APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Benco Dental SODIUM FLUORIDE 5.6 g/454g 66975-054_ac2d5b1c-2d7f-4931-8cdc-b81664096f5a 66975-054 HUMAN PRESCRIPTION DRUG Iris 60 Second APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Benco Dental SODIUM FLUORIDE 5.6 g/454g 66975-101_faf6eda4-7205-48e5-8e03-481e6f997397 66975-101 HUMAN OTC DRUG natural extensions Fragrance- Free Instant Hand Sanitizer Alcohol GEL TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part333E Benco Dental Company ALCOHOL 60 mL/100mL 66975-102_c7945e12-602e-451d-aac1-758f0f7de625 66975-102 HUMAN OTC DRUG natural extensions Antibacterial Liquid Hand Wash TRICLOSAN SOAP TOPICAL 20101015 OTC MONOGRAPH NOT FINAL part333E Benco Dental Company TRICLOSAN 3 mL/1000mL 66975-103_00a40d27-74a0-4c79-9bae-01054ca1f0e0 66975-103 HUMAN OTC DRUG natural extensions Antibacterial Foaming Hand Wash Triclosan SOAP TOPICAL 20101115 OTC MONOGRAPH NOT FINAL part333E Benco Dental Company TRICLOSAN 3 mL/1000mL 66975-350_aa02c752-6c50-4523-8198-7177fe773dba 66975-350 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g 66975-351_6b848efe-593a-497b-9336-7a3d2b467425 66975-351 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g 66975-352_5d9d36b7-aa52-4c6d-a34c-56ffbfadd00c 66975-352 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g 66975-353_e38a1b59-efda-49fb-9609-8800b4b9e860 66975-353 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g 66975-354_23a9482f-e9c5-4b93-bec3-7cc99503320e 66975-354 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g 66975-355_ff623398-f21d-4bd3-93c1-9fa35a88a9a5 66975-355 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g 66975-356_d3255804-d0e2-4994-9f05-e9136e0b11fd 66975-356 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g 66975-357_72500c3b-3260-4cda-bf6a-c88bc7e055d9 66975-357 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g 66975-358_ab9e215e-b8e2-459c-826f-06415cb7a91b 66975-358 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g 66975-406_6b6c054c-dcb5-4d4b-9aa3-c91c91c3a684 66975-406 HUMAN PRESCRIPTION DRUG Mepivacaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA088387 Benco Dental MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 66975-415_42255c05-2c21-46bd-927d-6eb39fea56a0 66975-415 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111207 ANDA ANDA088389 Benco Dental EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .02; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 66975-416_6b6c054c-dcb5-4d4b-9aa3-c91c91c3a684 66975-416 HUMAN PRESCRIPTION DRUG Mepivacaine With Levonordefrin Mepivacaine Hydrochloride and Levonordefrin INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA088388 Benco Dental LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE .05; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 66975-425_080c1273-1d45-4b93-b41c-fdc2f8ffa6fc 66975-425 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111207 ANDA ANDA088390 Benco Dental EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 66977-022_1c718944-86af-4bc3-b7a6-8a8133d274e0 66977-022 HUMAN OTC DRUG Norml Shield dimethicone CREAM TOPICAL 19930201 OTC MONOGRAPH NOT FINAL part356 MPM Medical, Inc. DIMETHICONE 45 mg/g 66977-023_a09a309c-075c-4832-8de2-0aa3b9b167d4 66977-023 HUMAN OTC DRUG Anti-Fungal clotrimazole CREAM TOPICAL 20021014 OTC MONOGRAPH FINAL part333C MPM Medical, Inc. CLOTRIMAZOLE 10 mg/g 66977-032_89f7bc8e-68b0-4e62-b67c-d1f129513507 66977-032 HUMAN OTC DRUG Antiseptic benzethonium chloride SOLUTION TOPICAL 19970601 OTC MONOGRAPH NOT FINAL part333A MPM Medical, Inc. BENZETHONIUM CHLORIDE 1 mg/mL 66977-107_8c4a924e-8f26-4e85-82ed-b9939d1d674c 66977-107 HUMAN OTC DRUG REGENECARE HA lidocaine HCl GEL TOPICAL 20070105 OTC MONOGRAPH NOT FINAL part348 MPM Medical, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/g 66977-117_a99d01c1-4e4a-49b9-8b98-35ead76e4c3e 66977-117 HUMAN OTC DRUG REGENECARE HA lidocaine HCl GEL TOPICAL 20090601 OTC MONOGRAPH NOT FINAL part348 MPM Medical, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL 66988-100_a6bbb5f3-323e-4288-93af-6a6ce004ca8f 66988-100 HUMAN PRESCRIPTION DRUG Oxygen OXYGEN GAS RESPIRATORY (INHALATION) 20100614 UNAPPROVED MEDICAL GAS Jenco Medical and Mobility, Inc OXYGEN 1 L/L 66992-281_faf50d93-ff0d-464b-89e2-ff2abe2cc2fb 66992-281 HUMAN OTC DRUG Entex T Guaifenesin and Pseudoephedrine Hydrochloride TABLET ORAL 20100930 OTC MONOGRAPH FINAL part341 WraSer Pharmaceuticals, LLC GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 375; 60 mg/1; mg/1 66992-340_e87737f3-85f9-4e86-b66a-a59765b77611 66992-340 HUMAN PRESCRIPTION DRUG Trezix acetaminophen, caffeine, dihydrocodeine bitartrate CAPSULE ORAL 20090901 ANDA ANDA040688 WraSer LLC ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 320.5; 30; 16 mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 66992-399_1a5d7233-4453-42a5-8144-a4276db39660 66992-399 HUMAN PRESCRIPTION DRUG Regimex benzphetamine hydrochloride TABLET ORAL 20130201 ANDA ANDA090473 Wraser Pharmaceuticals BENZPHETAMINE HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 66992-490_768fad6d-02fa-4c77-b3ee-dc890b77bf1c 66992-490 HUMAN OTC DRUG VAZOBID-PD Brompheniramine maleate and Phenylephrine hydrochloride LIQUID ORAL 20111201 OTC MONOGRAPH FINAL part341 Wraser Pharmaceuticals BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1.2; 2 mg/mL; mg/mL 66992-840_42b7a53c-5674-4da0-a04f-f2c1d4245c45 66992-840 HUMAN PRESCRIPTION DRUG Trezix acetaminophen, caffeine, dihydrocodeine bitartrate CAPSULE ORAL 20141201 ANDA ANDA204785 WraSer LLC ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 320.5; 30; 16 mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 66993-021_d1a209d1-389d-4722-9598-dbd96d52fb28 66993-021 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride Levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20120820 NDA AUTHORIZED GENERIC NDA020837 Prasco Laboratories LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 66993-022_d1a209d1-389d-4722-9598-dbd96d52fb28 66993-022 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20120820 NDA AUTHORIZED GENERIC NDA020837 Prasco Laboratories LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 66993-023_d1a209d1-389d-4722-9598-dbd96d52fb28 66993-023 HUMAN PRESCRIPTION DRUG Levalbuterol hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20120820 NDA AUTHORIZED GENERIC NDA020837 Prasco Laboratories LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 66993-025_9c0f688c-0cc4-4a69-8cf8-75cd3c8cd7f9 66993-025 HUMAN PRESCRIPTION DRUG Desmopressin Acetate DESMOPRESSIN ACETATE SPRAY NASAL 20140101 NDA AUTHORIZED GENERIC NDA021333 Prasco Laboratories DESMOPRESSIN ACETATE 10 ug/.1mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 66993-057_182b36c9-4e35-40a5-b620-e84b9ef66a4d 66993-057 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET ORAL 20130628 NDA AUTHORIZED GENERIC NDA009768 Prasco Laboratories HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 66993-060_2bfb3482-68ec-45fe-a185-5ebbd00a9cdd 66993-060 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil HCl atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20120727 NDA AUTHORIZED GENERIC NDA021078 Prasco Laboratories ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 66993-062_ec493472-dd0b-491e-a962-316d74cc1c8a 66993-062 HUMAN PRESCRIPTION DRUG Atovaquone atovaquone SUSPENSION ORAL 20140320 NDA AUTHORIZED GENERIC NDA020500 Prasco Laboratories ATOVAQUONE 750 mg/5mL Antimalarial [EPC],Antiprotozoal [EPC] 66993-070_b0e133c7-60fe-450e-8ee0-ab292a9a7282 66993-070 HUMAN PRESCRIPTION DRUG Mefenamic Acid mefenamic acid CAPSULE ORAL 20110711 NDA AUTHORIZED GENERIC NDA015034 Prasco Laboratories MEFENAMIC ACID 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 66993-075_c6468771-ad2f-4423-9929-fee6c45771c5 66993-075 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140124 NDA AUTHORIZED GENERIC NDA021427 Prasco Laboratories DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66993-076_c6468771-ad2f-4423-9929-fee6c45771c5 66993-076 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140124 NDA AUTHORIZED GENERIC NDA021427 Prasco Laboratories DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66993-077_c6468771-ad2f-4423-9929-fee6c45771c5 66993-077 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140124 NDA AUTHORIZED GENERIC NDA021427 Prasco Laboratories DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66993-090_430adfa1-d2da-491c-adb3-cd7c74f7cae9 66993-090 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid TABLET ORAL 20100517 NDA AUTHORIZED GENERIC NDA022430 Prasco Laboratories TRANEXAMIC ACID 650 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 66993-114_d2fdcf18-3c74-43d5-8579-2604a3acdca8 66993-114 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141022 NDA AUTHORIZED GENERIC NDA021416 Prasco Laboratories PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] 66993-115_d2fdcf18-3c74-43d5-8579-2604a3acdca8 66993-115 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141022 NDA AUTHORIZED GENERIC NDA021416 Prasco Laboratories PROPAFENONE HYDROCHLORIDE 325 mg/1 Antiarrhythmic [EPC] 66993-116_d2fdcf18-3c74-43d5-8579-2604a3acdca8 66993-116 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141022 NDA AUTHORIZED GENERIC NDA021416 Prasco Laboratories PROPAFENONE HYDROCHLORIDE 425 mg/1 Antiarrhythmic [EPC] 66993-121_a2b02c92-a449-4624-9936-423a9c0993e2 66993-121 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid TABLET ORAL 20100517 NDA AUTHORIZED GENERIC NDA022430 Prasco Laboratories TRANEXAMIC ACID 650 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 66993-160_1d044024-733a-4c91-a415-035c4c7a47a1 66993-160 HUMAN PRESCRIPTION DRUG leflunomide leflunomide TABLET, FILM COATED ORAL 19980910 NDA AUTHORIZED GENERIC NDA020905 Prasco LLC LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] 66993-161_1d044024-733a-4c91-a415-035c4c7a47a1 66993-161 HUMAN PRESCRIPTION DRUG leflunomide leflunomide TABLET, FILM COATED ORAL 19980910 NDA AUTHORIZED GENERIC NDA020905 Prasco LLC LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] 66993-175_720b2f05-f5f4-40b8-a2c7-b3e8967249cb 66993-175 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride dorzolamide hydrochloride SOLUTION OPHTHALMIC 19941209 NDA NDA020408 Prasco Laboratories DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] 66993-185_ec729b40-778d-4045-8af2-4bbe335de014 66993-185 HUMAN PRESCRIPTION DRUG Doxercalciferol doxercalciferol CAPSULE, LIQUID FILLED ORAL 20140114 NDA AUTHORIZED GENERIC NDA020862 Prasco Laboratories DOXERCALCIFEROL .5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] 66993-186_ec729b40-778d-4045-8af2-4bbe335de014 66993-186 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol CAPSULE, LIQUID FILLED ORAL 20140114 NDA AUTHORIZED GENERIC NDA020862 Prasco Laboratories DOXERCALCIFEROL 1 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] 66993-187_b21ad877-298b-432d-b16c-0123968da751 66993-187 HUMAN PRESCRIPTION DRUG Doxercalciferol doxercalciferol CAPSULE, LIQUID FILLED ORAL 20140114 NDA AUTHORIZED GENERIC NDA020862 Prasco Laboratories DOXERCALCIFEROL 2.5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] 66993-190_2f0247ac-9650-4db2-a81f-70490d87aba5 66993-190 HUMAN PRESCRIPTION DRUG dorzolamide hydrochloride-timolol maleate dorzolamide hydrochloride and timolol maleate SOLUTION OPHTHALMIC 19980407 NDA NDA020869 Prasco Laboratories DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] 66993-210_57c219d8-58ec-4e9a-86d1-9a8627822e2f 66993-210 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride vancomycin hydrochloride CAPSULE ORAL 20120410 NDA AUTHORIZED GENERIC NDA050606 Prasco Laboratories VANCOMYCIN HYDROCHLORIDE 125 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 66993-211_57c219d8-58ec-4e9a-86d1-9a8627822e2f 66993-211 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride vancomycin hydrochloride CAPSULE ORAL 20120410 NDA AUTHORIZED GENERIC NDA050606 Prasco Laboratories VANCOMYCIN HYDROCHLORIDE 250 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 66993-405_90593214-5e4d-4b91-b308-a82311a3e4f9 66993-405 HUMAN PRESCRIPTION DRUG Ursodiol Tablets, 250 mg Ursodiol TABLET, FILM COATED ORAL 20090701 NDA AUTHORIZED GENERIC NDA020675 PRASCO Laboratories URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 66993-406_90593214-5e4d-4b91-b308-a82311a3e4f9 66993-406 HUMAN PRESCRIPTION DRUG Ursodiol Tablets, 500 mg ursodiol TABLET, FILM COATED ORAL 20090701 NDA AUTHORIZED GENERIC NDA020675 PRASCO Laboratories URSODIOL 500 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 66993-407_c9d1cfcb-7fd7-4256-a819-dedfd67de358 66993-407 HUMAN PRESCRIPTION DRUG Carbamazepine carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20111215 NDA AUTHORIZED GENERIC NDA020712 Prasco Laboratories CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 66993-408_c9d1cfcb-7fd7-4256-a819-dedfd67de358 66993-408 HUMAN PRESCRIPTION DRUG Carbamazepine carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20111215 NDA AUTHORIZED GENERIC NDA020712 Prasco Laboratories CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 66993-409_c9d1cfcb-7fd7-4256-a819-dedfd67de358 66993-409 HUMAN PRESCRIPTION DRUG Carbamazepine carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20111215 NDA AUTHORIZED GENERIC NDA020712 Prasco Laboratories CARBAMAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 66993-410_22ff580c-e26b-4f25-a874-63fd6b016a2d 66993-410 HUMAN PRESCRIPTION DRUG Mesalamine mesalamine CAPSULE ORAL 19930510 NDA NDA020049 Prasco Laboratories MESALAMINE 250 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 66993-411_22ff580c-e26b-4f25-a874-63fd6b016a2d 66993-411 HUMAN PRESCRIPTION DRUG Mesalamine mesalamine CAPSULE ORAL 20040708 NDA NDA020049 Prasco Laboratories MESALAMINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 66993-412_8e0bc714-1de5-45ef-960a-9186b2d0236f 66993-412 HUMAN PRESCRIPTION DRUG omeprazole/sodium bicarbonate omeprazole, sodium bicarbonate CAPSULE ORAL 20060227 NDA AUTHORIZED GENERIC NDA021849 Prasco, Laboratories OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 66993-413_8e0bc714-1de5-45ef-960a-9186b2d0236f 66993-413 HUMAN PRESCRIPTION DRUG omeprazole/sodium bicarbonate omeprazole, sodium bicarbonate CAPSULE ORAL 20060227 NDA AUTHORIZED GENERIC NDA021849 Prasco, Laboratories OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 66993-416_87aa6bdc-f97c-46f9-9d83-1b954151af0c 66993-416 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium GRANULE ORAL 20130726 NDA AUTHORIZED GENERIC NDA021409 Prasco Laboratories MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 66993-417_b99be7b4-5049-4869-8257-4f95c94d42d1 66993-417 HUMAN PRESCRIPTION DRUG Raloxifene hydrochloride Raloxifene hydrochloride TABLET ORAL 20140301 NDA AUTHORIZED GENERIC NDA020815 Prasco Laboratories RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 66993-460_e153dd10-b2d7-44ff-9615-46355d7708fe 66993-460 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 Prasco Laboratories OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 66993-461_e153dd10-b2d7-44ff-9615-46355d7708fe 66993-461 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 Prasco Laboratories OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 66993-462_e153dd10-b2d7-44ff-9615-46355d7708fe 66993-462 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 Prasco Laboratories OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 66993-463_e153dd10-b2d7-44ff-9615-46355d7708fe 66993-463 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 Prasco Laboratories OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 66993-464_e153dd10-b2d7-44ff-9615-46355d7708fe 66993-464 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 Prasco Laboratories OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 66993-465_e153dd10-b2d7-44ff-9615-46355d7708fe 66993-465 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 Prasco Laboratories OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 66993-466_e153dd10-b2d7-44ff-9615-46355d7708fe 66993-466 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20111025 ANDA ANDA091415 Prasco Laboratories OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 66993-467_e153dd10-b2d7-44ff-9615-46355d7708fe 66993-467 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20111025 ANDA ANDA091415 Prasco Laboratories OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 66993-468_e153dd10-b2d7-44ff-9615-46355d7708fe 66993-468 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20111025 ANDA ANDA091415 Prasco Laboratories OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 66993-469_e153dd10-b2d7-44ff-9615-46355d7708fe 66993-469 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20111025 ANDA ANDA091415 Prasco Laboratories OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 66993-470_3a9d3763-8f4e-42ad-815a-a98f146f9812 66993-470 HUMAN PRESCRIPTION DRUG Cromolyn Sodium Cromolyn Sodium SOLUTION, CONCENTRATE ORAL 20111212 NDA AUTHORIZED GENERIC NDA020479 Prasco Laboratories CROMOLYN SODIUM 20 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] 66993-471_c694ddbc-2d58-4aba-b5a1-013caf2e16f3 66993-471 HUMAN PRESCRIPTION DRUG Nitrofurantoin nitrofurantoin SUSPENSION ORAL 20110816 NDA AUTHORIZED GENERIC NDA009175 Prasco Laboratories NITROFURANTOIN 25 mg/5mL Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 66993-472_656694fd-7f17-4d51-826f-f76cce72bc16 66993-472 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120227 NDA AUTHORIZED GENERIC NDA020356 Prasco Laboratories NISOLDIPINE 8.5 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 66993-473_656694fd-7f17-4d51-826f-f76cce72bc16 66993-473 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120227 NDA AUTHORIZED GENERIC NDA020356 Prasco Laboratories NISOLDIPINE 17 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 66993-475_656694fd-7f17-4d51-826f-f76cce72bc16 66993-475 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120227 NDA AUTHORIZED GENERIC NDA020356 Prasco Laboratories NISOLDIPINE 34 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] 66993-478_5a2da285-1aa1-428b-8e65-261ef625e41e 66993-478 HUMAN PRESCRIPTION DRUG Lamivudine lamivudine TABLET, FILM COATED ORAL 20140905 NDA AUTHORIZED GENERIC NDA021003 Prasco Laboratories LAMIVUDINE 100 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 66993-534_824d2e75-f8a4-4e36-b0ae-273d5f3026a5 66993-534 HUMAN PRESCRIPTION DRUG R-Tanna Phenylephrine Tannate and Chlorpheniramine Tannate TABLET ORAL 20051019 UNAPPROVED DRUG OTHER Prasco Laboratories CHLORPHENIRAMINE TANNATE; PHENYLEPHRINE TANNATE 9; 25 mg/1; mg/1 alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 66993-537_1b31e22b-3367-4e55-9930-d9b526fa0d91 66993-537 HUMAN PRESCRIPTION DRUG R-Tanna Pediatric Suspension Phenylephrine Tannate, Chlorpheniramine Tannate SUSPENSION ORAL 20100203 UNAPPROVED DRUG OTHER Prasco Laboratories CHLORPHENIRAMINE TANNATE; PHENYLEPHRINE TANNATE 4.5; 5 mg/5mL; mg/5mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 66993-662_c77a3350-24a8-43ad-b08a-f44cc4687168 66993-662 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Prasco Laboratories DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66993-663_c77a3350-24a8-43ad-b08a-f44cc4687168 66993-663 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Prasco Laboratories DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66993-664_c77a3350-24a8-43ad-b08a-f44cc4687168 66993-664 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Prasco Laboratories DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 66993-709_adb0fcf4-599f-40b1-b608-7399946e9765 66993-709 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20010112 NDA AUTHORIZED GENERIC NDA021208 Prasco Laboratories MIRTAZAPINE 15 mg/1 66993-711_adb0fcf4-599f-40b1-b608-7399946e9765 66993-711 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20010112 NDA AUTHORIZED GENERIC NDA021208 Prasco Laboratories MIRTAZAPINE 30 mg/1 66993-712_adb0fcf4-599f-40b1-b608-7399946e9765 66993-712 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20010112 NDA AUTHORIZED GENERIC NDA021208 Prasco Laboratories MIRTAZAPINE 45 mg/1 66993-875_39f2b134-d4dc-49bd-8709-e4d8e33814a6 66993-875 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide sulfacetamide sodium LOTION TOPICAL 19961223 NDA AUTHORIZED GENERIC NDA019931 Prasco Laboratories SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 66993-877_9bc5c05f-8dc1-45f3-8ff4-caaffc66339d 66993-877 HUMAN PRESCRIPTION DRUG Calcipotriene Calcipotriene CREAM TOPICAL 19961001 NDA NDA020554 Prasco Laboratories CALCIPOTRIENE 50 ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 66993-878_e7f1be67-61eb-484d-9f4b-14a909019866 66993-878 HUMAN PRESCRIPTION DRUG calcipotriene calcipotriene OINTMENT TOPICAL 20130701 NDA AUTHORIZED GENERIC NDA020273 Prasco Laboratories CALCIPOTRIENE 50 ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 66993-879_5f2a008d-f5ef-48f3-8329-2251e5c0bc6e 66993-879 HUMAN PRESCRIPTION DRUG Econazole Nitrate econazole nitrate CREAM TOPICAL 20070901 20150228 ANDA ANDA076574 Prasco Laboratories ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 66993-880_a241f69a-4de4-441a-a3eb-4c9e82d7a5bd 66993-880 HUMAN PRESCRIPTION DRUG Prednicarbate Prednicarbate CREAM TOPICAL 20070430 NDA AUTHORIZED GENERIC NDA020279 Prasco Laboratories PREDNICARBATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 66993-884_8fbc1e15-f9d1-46cd-980d-38afa0e22cb0 66993-884 HUMAN PRESCRIPTION DRUG ADAPALENE ADAPALENE GEL TOPICAL 20140101 NDA AUTHORIZED GENERIC NDA021753 Prasco Laboratories ADAPALENE 3 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 66993-887_64aa4b2e-75f5-4960-bdc3-e7beab8ebede 66993-887 HUMAN PRESCRIPTION DRUG Aliclen Salicylic Acid SHAMPOO TOPICAL 20110202 UNAPPROVED DRUG OTHER Prasco Laboratories SALICYLIC ACID 60 mg/mL 66993-888_3930d48d-3963-4e24-904e-62ea6eb79d85 66993-888 HUMAN PRESCRIPTION DRUG CLOBETASOL PROPIONATE clobetasol propionate AEROSOL, FOAM TOPICAL 20100115 NDA NDA021142 Prasco Laboratories CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 66993-893_0e6536a9-21a9-4164-a9b6-3c0b5265056f 66993-893 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Emulsion clobetasol propionate AEROSOL, FOAM TOPICAL 20130201 NDA AUTHORIZED GENERIC NDA022013 Prasco Laboratories CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 66993-894_7485bbf6-1c8c-4ae8-9549-3379af67e32c 66993-894 HUMAN PRESCRIPTION DRUG ACITRETIN acitretin CAPSULE ORAL 20130719 NDA AUTHORIZED GENERIC NDA019821 Prasco Laboratories ACITRETIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 66993-896_7485bbf6-1c8c-4ae8-9549-3379af67e32c 66993-896 HUMAN PRESCRIPTION DRUG ACITRETIN acitretin CAPSULE ORAL 20130719 NDA AUTHORIZED GENERIC NDA019821 Prasco Laboratories ACITRETIN 25 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 66993-897_ac7db056-5b42-41d9-8c5d-8dbb24e93e9e 66993-897 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate betamethasone dipropionate OINTMENT TOPICAL 20120515 NDA AUTHORIZED GENERIC NDA018741 Prasco Laboratories BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 66993-898_b55e700d-ae7b-4347-99f9-96e37b170d8a 66993-898 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM TOPICAL 19840710 NDA NDA018827 Prasco Laboratories BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE .5; 10 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 66993-902_c53bd3e5-6f8b-4f70-8303-102a5ac239a9 66993-902 HUMAN PRESCRIPTION DRUG Prascion Cleanser Sodium Sulfacetamide and Sulfur SOAP TOPICAL 20110805 UNAPPROVED DRUG OTHER Prasco Laboratories SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 66993-904_011573f5-f2be-478a-9578-b720cb572759 66993-904 HUMAN PRESCRIPTION DRUG Prascion RA Sodium Sulfacetamide and Sulfur CREAM TOPICAL 20101222 UNAPPROVED DRUG OTHER Prasco Laboratories SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 66993-905_0271490b-5dc6-4734-92f9-f26eeddf5ab6 66993-905 HUMAN PRESCRIPTION DRUG Prascion FC Sodium Sulfacetamide and Sulfur CLOTH TOPICAL 20110808 UNAPPROVED DRUG OTHER Prasco Laboratories SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 66993-925_9c745460-b5ba-4c38-ba35-f2d48cde1004 66993-925 HUMAN PRESCRIPTION DRUG Prascion RA Cream with Sunscreens Sodium sulfacetamide and sulfur CREAM TOPICAL 20090630 UNAPPROVED OTHER Prasco Laboratories SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/45g; mg/45g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 66993-934_50362a60-00c2-11e4-9191-0800200c9a66 66993-934 HUMAN PRESCRIPTION DRUG Testosterone Gel testosterone GEL TRANSDERMAL 20140609 NDA AUTHORIZED GENERIC NDA021454 Prasco Laboratories TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 66993-935_39a5bd5e-e3fe-44ee-ba61-6d4b8bdb0b18 66993-935 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole GEL VAGINAL 20070331 NDA AUTHORIZED GENERIC NDA020208 Prasco Laboratories METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 66993-942_b8d1bcf6-eb84-4efc-9e5b-d6b210618c23 66993-942 HUMAN PRESCRIPTION DRUG Mupirocin Calcium mupirocin calcium CREAM TOPICAL 20130128 NDA AUTHORIZED GENERIC NDA050746 Prasco Laboratories MUPIROCIN CALCIUM 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 66993-949_59ee0e43-5574-41d9-b8c1-a1d536097ebe 66993-949 HUMAN PRESCRIPTION DRUG Clindamycin - Benzoyl Peroxide clindamycin phosphate and benzoyl peroxide GEL TOPICAL 20120627 NDA AUTHORIZED GENERIC NDA050741 Prasco Laboratories BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 50; 10 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 66993-960_e371c845-0a47-4afd-a51a-ebf4608f2f28 66993-960 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE CREAM TOPICAL 20090618 NDA AUTHORIZED GENERIC NDA020531 Prasco Laboratories METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 66993-961_a2cb7441-96fb-4afe-8bb6-44f00ac486c9 66993-961 HUMAN PRESCRIPTION DRUG metronidazole metronidazole LOTION TOPICAL 20090528 NDA AUTHORIZED GENERIC NDA020901 Prasco Laboratories METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 66993-962_8badc209-30e6-4bc6-895c-b8324600eaac 66993-962 HUMAN PRESCRIPTION DRUG Metronidazole Topical Gel metronidazole GEL TOPICAL 20140301 NDA AUTHORIZED GENERIC NDA019737 Prasco Laboratories METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 67015-0000_cdb34602-be7c-4abe-943f-3d9de4fe9509 67015-0000 HUMAN OTC DRUG EAU THERMALE Avene Moderate Protection BROAD SPECTRUM SPF 20 OCTOCRYLENE, OCTINOXATE, TITANIUM DIOXIDE SPRAY TOPICAL 20130429 20170228 OTC MONOGRAPH NOT FINAL part352 Pierre Fabre Dermo-Cosmetique USA, Inc. OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 75; 100; 38 mg/mL; mg/mL; mg/mL 67015-0001_05f44c7c-696a-40c1-b62f-aea9f9d59e23 67015-0001 HUMAN OTC DRUG EAU THERMALE Avene Antirougeurs DAY Redness-relief Soothing BROAD SPECTRUM SPF 25 OCTOCRYLENE, OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20130429 OTC MONOGRAPH NOT FINAL part352 Pierre Fabre Dermo Cosmetique OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 75; 40; 45 mg/mL; mg/mL; mg/mL 67015-0002_e4958ec7-562d-43a2-8272-a7ecee89b103 67015-0002 HUMAN OTC DRUG EAU THERMALE Avene Hydrance Optimale Hydrating BROAD SPECTRUM SPF 25 TITANIUM DIOXIDE CREAM TOPICAL 20130429 OTC MONOGRAPH NOT FINAL part352 Pierre Fabre Dermo Cosmetique OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 75; 80; 32 mg/mL; mg/mL; mg/mL 67015-0003_5093ebc6-cec5-42cd-a23e-a546986b0c80 67015-0003 HUMAN OTC DRUG EAU THERMALE Avene High Protection Mineral BROAD SPECTRUM SPF 50 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130429 20170630 OTC MONOGRAPH NOT FINAL part352 Pierre Fabre Dermo-Cosmetique USA, Inc. TITANIUM DIOXIDE; ZINC OXIDE 107.8; 24 mg/mL; mg/mL 67015-0004_5a681337-388d-4deb-a1be-453642de6040 67015-0004 HUMAN OTC DRUG EAU THERMALE AVENE Akerat S Psoriasis Skin SALICYLIC ACID CREAM TOPICAL 20130429 20160303 OTC MONOGRAPH FINAL part358H Pierre Fabre Dermo-Cosmetique USA, Inc. SALICYLIC ACID 20 mg/mL 67015-1100_0fd30277-3ae0-4795-b944-0f2a8de90e89 67015-1100 HUMAN OTC DRUG HAUTE PROTECTION High Protection Tinted Compact BROAD SPECTRUM SPF 50 BEIGE TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part352 Pierre Fabre Dermo Cosmetique TITANIUM DIOXIDE; ZINC OXIDE 18; 4.9 g/100g; g/100g 67015-1101_1397c8f4-8832-4f4e-b42c-9d4b2860cdc6 67015-1101 HUMAN OTC DRUG HAUTE PROTECTION High Protection Tinted Compact BROAD SPECTRUM SPF 50 HONEY TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part352 Pierre Fabre Dermo Cosmetique TITANIUM DIOXIDE; ZINC OXIDE 18; 4.9 g/100g; g/100g 67015-1200_ea503de1-604a-4e43-a2e4-855133b2f3cb 67015-1200 HUMAN OTC DRUG Glytone Suncare SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SPRAY TOPICAL 20110609 OTC MONOGRAPH FINAL part352 Pierre Fabre Dermo-Cosmetique USA, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL 67024-001_470fed10-71f1-43c3-9e35-d2cbae3e1704 67024-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020308 UNAPPROVED MEDICAL GAS The Service Center LLC OXYGEN 992 mL/L 67038-100_1374b442-9657-4e3c-8a68-b7d5ad9a804b 67038-100 HUMAN OTC DRUG LABORATOIRE REMEDE TRANSLUCENT UV COAT TINT 0 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20100720 OTC MONOGRAPH FINAL part352 Bliss World, LLC OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 2; 8.8 mL/100mL; mL/100mL; mL/100mL 67038-101_17f6a927-0944-43d6-b66a-40d2e4c02c38 67038-101 HUMAN OTC DRUG LABORATOIRE REMEDE TRANSLUCENT UV COAT TINT 1 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20100720 OTC MONOGRAPH FINAL part352 Bliss World, LLC OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 2; 8.8 mL/100mL; mL/100mL; mL/100mL 67038-102_39dcd94a-c0e8-4cef-bc98-a8ec8736d7d0 67038-102 HUMAN OTC DRUG LABORATOIRE REMEDE TRANSLUCENT UV COAT TINT 2 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20100720 OTC MONOGRAPH FINAL part352 Bliss World, LLC OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 2; 8.8 mL/100mL; mL/100mL; mL/100mL 67038-103_c6064267-5da8-434e-9e75-fa5ee178597e 67038-103 HUMAN OTC DRUG LABORATOIRE REMEDE TRANSLUCENT UV COAT TINT 3 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20100720 OTC MONOGRAPH FINAL part352 Bliss World, LLC OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 2; 8.8 mL/100mL; mL/100mL; mL/100mL 67038-104_742e3e62-e15e-4778-bc4d-c967bbbd8cc7 67038-104 HUMAN OTC DRUG no zit sherlock acnespot treatment spot treatment SALICYLIC ACID GEL TOPICAL 20101101 OTC MONOGRAPH FINAL part333D Bliss World LLC SALICYLIC ACID 3 mg/15mL 67038-105_e6a2b08e-b63d-45b8-b799-3b7e6166225d 67038-105 HUMAN OTC DRUG fabulous face spf 15 AVOBENZONE, HOMOSALATE, OXYBENZONE LOTION TOPICAL 20110601 OTC MONOGRAPH FINAL part352 Bliss World LLC AVOBENZONE; HOMOSALATE; OXYBENZONE 1.5; 4; 1.75 g/50mL; g/50mL; g/50mL 67038-106_5217c88c-a43f-4eb9-bcac-62c4a494eafd 67038-106 HUMAN OTC DRUG no zit sherlock acne correcting SALICYLIC ACID GEL TOPICAL 20100401 OTC MONOGRAPH FINAL part333D Bliss World LLC SALICYLIC ACID 1 mL/100mL 67038-107_638f3c5c-ea90-4ca1-ab47-418260f4f3e3 67038-107 HUMAN OTC DRUG no zit sherlock acne oil control SALICYLIC ACID CREAM TOPICAL 20100401 OTC MONOGRAPH FINAL part333D Bliss World LLC SALICYLIC ACID 2 mL/100mL 67038-108_5bb766ed-4fb7-4356-ac5b-8b14d00a87c5 67038-108 HUMAN OTC DRUG no zit sherlock acne purifying cleanser toner SALICYLIC ACID GEL TOPICAL 20100401 OTC MONOGRAPH FINAL part333D Bliss World LLC SALICYLIC ACID 2 mL/100mL 67038-110_50b7ded3-9737-448a-b063-9fdc641373df 67038-110 HUMAN OTC DRUG THE YOUTH AS WE KNOW IT AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20120201 OTC MONOGRAPH FINAL part352 Bliss World LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 1.5; 4; 3.75; 2.5; 1.75 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL 67046-010_460a2e4d-f1a2-4e08-b2da-f10bc63391db 67046-010 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20100216 ANDA ANDA085966 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 67046-011_c958b45e-7ca1-400a-b723-56e8c3aa98d8 67046-011 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 67046-012_460a2e4d-f1a2-4e08-b2da-f10bc63391db 67046-012 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20100216 ANDA ANDA085968 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 67046-013_c958b45e-7ca1-400a-b723-56e8c3aa98d8 67046-013 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 67046-014_460a2e4d-f1a2-4e08-b2da-f10bc63391db 67046-014 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20100216 ANDA ANDA085971 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 67046-015_460a2e4d-f1a2-4e08-b2da-f10bc63391db 67046-015 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20100216 ANDA ANDA085967 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 67046-016_c958b45e-7ca1-400a-b723-56e8c3aa98d8 67046-016 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 67046-017_c958b45e-7ca1-400a-b723-56e8c3aa98d8 67046-017 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 67046-020_0fa44b89-29b3-44c7-b9b2-87fb0c226f5e 67046-020 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 19920731 NDA AUTHORIZED GENERIC NDA019787 Contract Pharmacy Services-PA AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 67046-024_6a175aa5-62de-4096-be2d-b0bf66f5e82a 67046-024 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20100802 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacy Services-PA ACETAMINOPHEN 325 mg/1 67046-025_21cbb0e9-4d1e-4a55-bc5a-a4086ca14356 67046-025 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20100802 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacy Services-PA ACETAMINOPHEN 325 mg/1 67046-026_065b4f7d-ec2f-4cdd-bab6-383e3c8a57fb 67046-026 HUMAN OTC DRUG Extra Strength Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20100802 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacy Services-PA ACETAMINOPHEN 500 mg/1 67046-027_b74b720d-3692-44f1-ab40-55ff612a95a6 67046-027 HUMAN OTC DRUG Extra Strength Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20100802 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacy Services-PA ACETAMINOPHEN 500 mg/1 67046-030_a2d29601-21aa-4e78-a725-6c1ea982e3ac 67046-030 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100407 ANDA ANDA073025 Contract Pharmacy Services-PA ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67046-031_b8cfe18e-7328-4832-aff8-0b4b9e715172 67046-031 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20110130 ANDA ANDA077877 Contract Pharmacy Services-PA ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67046-042_8ab4fb43-045f-4104-bd62-55f8d3bae95a 67046-042 HUMAN PRESCRIPTION DRUG benztropine mesylate benztropine mesylate TABLET ORAL 20100628 ANDA ANDA040103 Contract Pharmacy Services-PA BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 67046-043_8ab4fb43-045f-4104-bd62-55f8d3bae95a 67046-043 HUMAN PRESCRIPTION DRUG benztropine mesylate benztropine mesylate TABLET ORAL 20100628 ANDA ANDA040103 Contract Pharmacy Services-PA BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 67046-044_bcf6a343-36e4-482c-883f-09d020eedf16 67046-044 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20020802 ANDA ANDA075584 Contract Pharmacy Services-PA BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 67046-045_bcf6a343-36e4-482c-883f-09d020eedf16 67046-045 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20020702 ANDA ANDA075584 Contract Pharmacy Services-PA BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 67046-075_9ac9a12c-25a1-4547-8a79-a79f83854dc5 67046-075 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100224 ANDA ANDA075491 Contract Pharmacy Services-PA BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 67046-076_9ac9a12c-25a1-4547-8a79-a79f83854dc5 67046-076 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100224 ANDA ANDA075491 Contract Pharmacy Services-PA BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 67046-084_49a643c3-14ef-4bfd-bb66-be05e1696c7e 67046-084 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20100809 ANDA ANDA063083 Contract Pharmacy Services-PA CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 67046-085_9891d1bd-b662-4242-a01e-8151463bbf2d 67046-085 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE, GELATIN COATED ORAL 20100702 ANDA ANDA065194 Contract Pharmacy Services-PA CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 67046-086_8e06995c-26c9-4ef3-9421-16a2360db628 67046-086 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 20100224 ANDA ANDA070541 Contract Pharmacy Services-PA CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 67046-089_4ea37cb2-af4c-4fad-bcc4-c7a0e8101e9f 67046-089 HUMAN OTC DRUG Chlorpheniramine maleate Chlorpheniramine maleate TABLET ORAL 20110110 OTC MONOGRAPH FINAL part341 Contract Pharmacy Services-PA CHLORPHENIRAMINE MALEATE 4 mg/1 67046-092_e041ed3c-36d8-4a51-9ebc-b364be9016a4 67046-092 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET ORAL 20100825 OTC MONOGRAPH FINAL part341 Contract Pharmacy Services-PA CHLORPHENIRAMINE MALEATE 4 mg/1 67046-093_6747500f-a88c-41bc-8355-cb56a56b6b8f 67046-093 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET ORAL 20100830 OTC MONOGRAPH FINAL part341 Contract Pharmacy Services-PA CHLORPHENIRAMINE MALEATE 4 mg/1 67046-095_a0bd2115-4159-4277-84e9-f4d4bb0942c1 67046-095 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 20100818 ANDA ANDA070925 Contract Pharmacy Services-PA CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 67046-098_854c5011-1abf-4ce8-bc8f-65cd02483c72 67046-098 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20100729 ANDA ANDA070317 Contract Pharmacy Services-PA CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 67046-103_533f3ed8-4569-48e2-95ee-efe428896b8d 67046-103 HUMAN PRESCRIPTION DRUG chlorpromazine hydrochloride chlorpromazine hydrochloride TABLET, SUGAR COATED ORAL 20100225 ANDA ANDA084113 Contract Pharmacy Services-PA CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 67046-104_533f3ed8-4569-48e2-95ee-efe428896b8d 67046-104 HUMAN PRESCRIPTION DRUG chlorpromazine hydrochloride chlorpromazine hydrochloride TABLET, SUGAR COATED ORAL 20100225 ANDA ANDA084114 Contract Pharmacy Services-PA CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 67046-107_dce6a871-db80-4b59-9b30-ff970a05fa35 67046-107 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100630 ANDA ANDA077289 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-108_dce6a871-db80-4b59-9b30-ff970a05fa35 67046-108 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100630 ANDA ANDA077289 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-109_dce6a871-db80-4b59-9b30-ff970a05fa35 67046-109 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100630 ANDA ANDA077289 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-110_34d1685a-8e6a-46bc-8977-550979bf4ddd 67046-110 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20100701 ANDA ANDA078216 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-111_30abc373-2373-449c-9bb1-b22238402357 67046-111 HUMAN PRESCRIPTION DRUG Perrigo Citalopram Citalopram TABLET ORAL 20100225 ANDA ANDA077042 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-112_653233ce-04c3-4059-9d45-a7075ddbf920 67046-112 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20100406 ANDA ANDA077031 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-113_34d1685a-8e6a-46bc-8977-550979bf4ddd 67046-113 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20100701 ANDA ANDA078216 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-114_34d1685a-8e6a-46bc-8977-550979bf4ddd 67046-114 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20100701 ANDA ANDA078216 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-115_653233ce-04c3-4059-9d45-a7075ddbf920 67046-115 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20100407 ANDA ANDA077031 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-116_b808f809-40fa-43c6-a33f-2ec21a293051 67046-116 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20090901 ANDA ANDA077044 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-119_e9063c42-e71a-4cce-9cd9-9ed6a192c6bb 67046-119 HUMAN PRESCRIPTION DRUG cyclobenzaprine hydrochloride cyclobenzaprine hydrochloride TABLET ORAL 20100423 ANDA ANDA077563 Contract Pharmacy Services-PA CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 67046-120_ea1966a2-794c-434e-a9da-57890bd182fc 67046-120 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078182 Contract Pharmacy Services-PA DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 67046-121_ea1966a2-794c-434e-a9da-57890bd182fc 67046-121 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078182 Contract Pharmacy Services-PA DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 67046-122_a24e8e53-07b3-49be-87e4-124f7d3aeac1 67046-122 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100818 ANDA ANDA077567 Contract Pharmacy Services-PA DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 67046-124_1b53ec3a-dec0-48c2-831d-72b3d88242f1 67046-124 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20100830 OTC MONOGRAPH FINAL part341 Contract Pharmacy Services-PA DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 67046-125_1d026ead-c3de-4dc6-9d3c-5a603f6dde4e 67046-125 HUMAN OTC DRUG DIPHENDYDRAMINE HYDROCHLORIDE DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20100805 OTC MONOGRAPH FINAL part345 Contract Pharmacy Services-PA DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 67046-126_1d026ead-c3de-4dc6-9d3c-5a603f6dde4e 67046-126 HUMAN OTC DRUG DIPHENDYDRAMINE HYDROCHLORIDE DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20100805 OTC MONOGRAPH FINAL part345 Contract Pharmacy Services-PA DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 67046-127_c3be33a2-b7eb-4826-9c0c-9de24d54c173 67046-127 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20100805 ANDA ANDA080738 Contract Pharmacy Services-PA DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 67046-128_e08dc0ab-3c86-43d4-ab18-ce4212657484 67046-128 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110131 NDA NDA020690 Contract Pharmacy Services-PA DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 67046-129_e08dc0ab-3c86-43d4-ab18-ce4212657484 67046-129 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110131 NDA NDA020690 Contract Pharmacy Services-PA DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 67046-131_1edc1fca-9ac7-4adf-b894-bf8ca392ce4d 67046-131 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20100406 ANDA ANDA070791 Contract Pharmacy Services-PA DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 67046-132_1edc1fca-9ac7-4adf-b894-bf8ca392ce4d 67046-132 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20100406 ANDA ANDA070791 Contract Pharmacy Services-PA DOXEPIN HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] 67046-133_1edc1fca-9ac7-4adf-b894-bf8ca392ce4d 67046-133 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20100406 ANDA ANDA070791 Contract Pharmacy Services-PA DOXEPIN HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 67046-134_ec5cc9e9-aa3a-4c54-b0a1-de1449701f78 67046-134 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 Contract Pharmacy Services-PA DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 67046-135_b34eb07b-d8a7-4762-a457-9d64dd86b205 67046-135 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20100310 ANDA ANDA062396 Contract Pharmacy Services-PA DOXYCYCLINE HYCLATE 100 mg/1 67046-136_ec5cc9e9-aa3a-4c54-b0a1-de1449701f78 67046-136 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 Contract Pharmacy Services-PA DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 67046-139_808abf28-a936-4d62-bb94-9fbe51c571c4 67046-139 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20100730 OTC MONOGRAPH NOT FINAL part334 Contract Pharmacy Services-PA DOCUSATE SODIUM 100 mg/1 67046-140_0e96c2fb-21b3-4a49-96fd-51efb872342d 67046-140 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20070122 OTC MONOGRAPH NOT FINAL part334 Contract Pharmacy Services-PA DOCUSATE SODIUM 100 mg/1 67046-156_66f5c697-4daa-4b5f-8ee2-40fc70960459 67046-156 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20100802 ANDA ANDA075483 Contract Pharmacy Services-PA ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 67046-157_3980589d-98fd-4bf4-9e99-1084bcfd5946 67046-157 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20100407 ANDA ANDA075480 Contract Pharmacy Services-PA ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 67046-158_3980589d-98fd-4bf4-9e99-1084bcfd5946 67046-158 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20100407 ANDA ANDA075480 Contract Pharmacy Services-PA ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 67046-159_3980589d-98fd-4bf4-9e99-1084bcfd5946 67046-159 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20100628 ANDA ANDA075480 Contract Pharmacy Services-PA ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 67046-160_66f5c697-4daa-4b5f-8ee2-40fc70960459 67046-160 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20100802 ANDA ANDA075483 Contract Pharmacy Services-PA ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 67046-161_66f5c697-4daa-4b5f-8ee2-40fc70960459 67046-161 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20100802 ANDA ANDA075483 Contract Pharmacy Services-PA ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 67046-162_579dc7cc-903e-4c51-be12-ba6aa0c3a74e 67046-162 HUMAN OTC DRUG ASPIRIN Aspirin TABLET, FILM COATED ORAL 20100810 OTC MONOGRAPH FINAL part343 Contract Pharmacy Services-PA ASPIRIN 325 mg/1 67046-163_283f3428-3cd4-4f43-92ae-06c4b2ff3f37 67046-163 HUMAN OTC DRUG ASPIRIN LOW DOSE Aspirin TABLET, FILM COATED ORAL 20100817 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacy Services-PA ASPIRIN 81 mg/1 67046-164_4f9bd0b1-0836-473d-bf08-b7894984dc59 67046-164 HUMAN OTC DRUG ASPIRIN Aspirin TABLET, FILM COATED ORAL 20101101 OTC MONOGRAPH FINAL part343 Contract Pharmacy Services-PA ASPIRIN 325 mg/1 67046-165_390334bc-5c58-4c43-8d1c-6a9dc017891b 67046-165 HUMAN OTC DRUG ASPIRIN LOW DOSE CHEWABLE Aspirin TABLET, CHEWABLE ORAL 20100809 OTC MONOGRAPH FINAL part343 Contract Pharmacy Services-PA ASPIRIN 81 mg/1 67046-166_466f6fa5-79f9-4f53-971d-a5254b0750e3 67046-166 HUMAN OTC DRUG ASPIRIN LOW DOSE Aspirin TABLET, FILM COATED ORAL 20100809 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacy Services-PA ASPIRIN 81 mg/1 67046-167_5af27c8a-9b53-49fd-a518-fa95053b11da 67046-167 HUMAN OTC DRUG ASPIRIN LOW DOSE Aspirin TABLET, FILM COATED ORAL 20100810 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacy Services-PA ASPIRIN 81 mg/1 67046-168_24262441-3582-42b8-853e-6393bef275d1 67046-168 HUMAN OTC DRUG ASPIRIN LOW DOSE Aspirin TABLET, FILM COATED ORAL 20101103 OTC MONOGRAPH FINAL part343 Contract Pharmacy Services-PA ASPIRIN 81 mg/1 67046-205_e1e31142-4256-4b12-8d2b-29a6cf45dc91 67046-205 HUMAN OTC DRUG Fiber Lax Fiber lax TABLET ORAL 20100809 OTC MONOGRAPH NOT FINAL part334 Contract Pharmacy Services-PA CALCIUM POLYCARBOPHIL 500 mg/1 67046-210_8609ed02-0b30-4c82-bab1-4d51d92ec224 67046-210 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20100730 ANDA ANDA075452 Contract Pharmacy Services-PA FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-211_4e4d8017-9c1d-41eb-affb-8046e3548be9 67046-211 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20100405 ANDA ANDA075245 Contract Pharmacy Services-PA FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-212_a2d6beb9-bec4-4623-bcc9-7f1bfddb9f0b 67046-212 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20110125 ANDA ANDA076001 Contract Pharmacy Services-PA FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-215_b561a04c-b0a6-4da1-9955-172672f10669 67046-215 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20100413 ANDA ANDA080600 Contract Pharmacy Services-PA FOLIC ACID 1 mg/1 67046-216_a5477715-93d0-4240-9a96-c4f47e99604c 67046-216 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20101109 ANDA ANDA040756 Contract Pharmacy Services-PA FOLIC ACID 1 mg/1 67046-221_54410c7f-83a9-4797-9f81-7ca568130298 67046-221 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110208 ANDA ANDA018413 Contract Pharmacy Services-PA FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 67046-222_aae04ef8-9438-43f4-9418-66b55d7bd7dc 67046-222 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20100412 NDA NDA018569 Contract Pharmacy Services-PA FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 67046-223_9c400666-a559-471f-9024-2f5b24455dee 67046-223 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100719 ANDA ANDA078428 Contract Pharmacy Services-PA GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67046-224_9c400666-a559-471f-9024-2f5b24455dee 67046-224 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100412 ANDA ANDA078428 Contract Pharmacy Services-PA GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67046-227_33b9c9ba-f71c-49f9-9bfc-f0d8a68aeab6 67046-227 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20090830 ANDA ANDA077662 Contract Pharmacy Services-PA GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67046-228_1d44526e-563e-4cd2-9625-983d8c31a434 67046-228 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110501 ANDA ANDA078010 Contract Pharmacy Services-PA FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 67046-230_1c8945d1-2292-4c31-8ba4-19bece8cec8d 67046-230 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20100405 ANDA ANDA074256 Contract Pharmacy Services-PA GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 67046-231_e2ec8e47-8f4e-44cc-82ff-1d4511d3fadd 67046-231 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20101109 ANDA ANDA077836 Contract Pharmacy Services-PA GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 67046-235_e1f70f24-1a4d-4861-9917-859bca58b865 67046-235 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20100405 ANDA ANDA074223 Contract Pharmacy Services-PA GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 67046-240_b61ab462-de4d-4ec4-b0b1-5e6863d9279e 67046-240 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20020806 ANDA ANDA076257 Contract Pharmacy Services-PA GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 67046-250_78987a51-82f7-4ca6-80ad-fa22d1f3e11a 67046-250 HUMAN PRESCRIPTION DRUG Guaifenesin guaifenesin TABLET ORAL 20101006 UNAPPROVED DRUG OTHER Contract Pharmacy Services-PA GUAIFENESIN 200 mg/1 67046-251_9de5e639-d676-4379-9cb5-d99014ebca6c 67046-251 HUMAN OTC DRUG Guaifenesin GUAIFENESIN TABLET ORAL 20110127 OTC MONOGRAPH FINAL part341 Contract Pharmacy Services-PA GUAIFENESIN 200 mg/1 67046-268_0027b8a3-73bf-4005-a7e3-b035f451a861 67046-268 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20100728 ANDA ANDA070278 Contract Pharmacy Services-PA HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 67046-271_e6edac46-8e5d-4180-a35e-510ecd534367 67046-271 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20101109 ANDA ANDA084878 Contract Pharmacy Services-PA HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 67046-272_e6edac46-8e5d-4180-a35e-510ecd534367 67046-272 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20101109 ANDA ANDA084878 Contract Pharmacy Services-PA HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 67046-273_fbd5b7f2-5571-4361-af2b-4149b5f72f03 67046-273 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100309 ANDA ANDA083177 Contract Pharmacy Services-PA HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 67046-274_fbd5b7f2-5571-4361-af2b-4149b5f72f03 67046-274 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100309 ANDA ANDA083177 Contract Pharmacy Services-PA HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 67046-275_fe6200cc-3182-473c-a90a-a8caa2fb2818 67046-275 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100816 ANDA ANDA040702 Contract Pharmacy Services-PA HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 67046-276_fe6200cc-3182-473c-a90a-a8caa2fb2818 67046-276 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100816 ANDA ANDA040702 Contract Pharmacy Services-PA HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 67046-281_2bbcabc3-657f-4b2e-a473-774adfeba78e 67046-281 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate HYDROXYZINE PAMOATE CAPSULE ORAL 20100816 ANDA ANDA087479 Contract Pharmacy Services-PA HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 67046-282_2bbcabc3-657f-4b2e-a473-774adfeba78e 67046-282 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate HYDROXYZINE PAMOATE CAPSULE ORAL 20100816 ANDA ANDA086183 Contract Pharmacy Services-PA HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 67046-300_b022458f-564e-4b5f-9541-80fadd61b733 67046-300 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100414 ANDA ANDA075682 Contract Pharmacy Services-PA IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67046-302_ebf71efe-e39a-4642-bf3a-e4781360ec7b 67046-302 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20100816 ANDA ANDA072096 Contract Pharmacy Services-PA IBUPROFEN 200 mg/1 67046-303_beec2bfd-1ba9-46b2-84f0-6a47766048e4 67046-303 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20100802 ANDA ANDA072096 Contract Pharmacy Services-PA IBUPROFEN 200 mg/1 67046-308_b022458f-564e-4b5f-9541-80fadd61b733 67046-308 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100412 ANDA ANDA075682 Contract Pharmacy Services-PA IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67046-309_6f3018fb-cec9-4908-8c70-ceeedd7d240d 67046-309 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20090922 ANDA ANDA075682 Contract Pharmacy Services-PA IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67046-310_6f3018fb-cec9-4908-8c70-ceeedd7d240d 67046-310 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20090922 ANDA ANDA075682 Contract Pharmacy Services-PA IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67046-311_6f3018fb-cec9-4908-8c70-ceeedd7d240d 67046-311 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091001 ANDA ANDA075682 Contract Pharmacy Services-PA IBUPROFEN 800 1/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67046-312_b022458f-564e-4b5f-9541-80fadd61b733 67046-312 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100414 ANDA ANDA075682 Contract Pharmacy Services-PA IBUPROFEN 800 1/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67046-330_3d5df05a-f4af-48d8-b880-97dfb92e900c 67046-330 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20100730 NDA NDA018858 Contract Pharmacy Services-PA INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67046-331_3d5df05a-f4af-48d8-b880-97dfb92e900c 67046-331 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20100730 ANDA ANDA070624 Contract Pharmacy Services-PA INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67046-333_ec0df56a-7746-45f2-88dc-a975cf48abc9 67046-333 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20100802 ANDA ANDA080937 Contract Pharmacy Services-PA ISONIAZID 300 mg/1 Antimycobacterial [EPC] 67046-350_cd9e04d1-4a0a-4885-9ccb-8a51ff112465 67046-350 HUMAN PRESCRIPTION DRUG Klor-Con Extended-release Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Contract Pharmacy Services-PA POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 67046-425_db57a1c8-83d3-4348-85e5-8fe3b950cce5 67046-425 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100812 ANDA ANDA077321 Contract Pharmacy Services-PA LISINOPRIL 10 mg/1 67046-426_350e0a50-2819-4de3-83cf-73c63ac248df 67046-426 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020702 ANDA ANDA075944 Contract Pharmacy Services-PA LISINOPRIL 10 mg/1 67046-427_db57a1c8-83d3-4348-85e5-8fe3b950cce5 67046-427 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100812 ANDA ANDA077321 Contract Pharmacy Services-PA LISINOPRIL 20 mg/1 67046-428_350e0a50-2819-4de3-83cf-73c63ac248df 67046-428 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020802 ANDA ANDA075944 Contract Pharmacy Services-PA LISINOPRIL 20 mg/1 67046-430_1bde6fe0-fc5a-4ad5-95a2-71d5ad7824c0 67046-430 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 20100406 NDA NDA017812 Contract Pharmacy Services-PA LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 67046-431_95330e0b-3884-495c-bf57-6bcafebba5e8 67046-431 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20100406 ANDA ANDA076243 Contract Pharmacy Services-PA LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 67046-460_463f684a-cd09-4b3a-8dca-8398125183fd 67046-460 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100409 ANDA ANDA077064 Contract Pharmacy Services-PA METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 67046-461_463f684a-cd09-4b3a-8dca-8398125183fd 67046-461 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100729 ANDA ANDA077064 Contract Pharmacy Services-PA METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 67046-462_463f684a-cd09-4b3a-8dca-8398125183fd 67046-462 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100729 ANDA ANDA077064 Contract Pharmacy Services-PA METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 67046-466_09721fb9-d3bd-4fc3-be79-79bc653a8289 67046-466 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Contract Pharmacy Services-PA METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 67046-467_396ddbcd-82cb-4ac1-b80d-a00b290ccd0f 67046-467 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20100301 ANDA ANDA090200 Contract Pharmacy Services-PA METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 67046-474_deb70186-796e-4e52-a7e8-afd8c17e637c 67046-474 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20110125 ANDA ANDA078459 Contract Pharmacy Services-PA METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67046-475_bc1f3dcd-f929-4c16-ac8e-59105fa46c2d 67046-475 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090610 ANDA ANDA073288 Contract Pharmacy Services-PA METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67046-477_bc1f3dcd-f929-4c16-ac8e-59105fa46c2d 67046-477 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090610 ANDA ANDA073289 Contract Pharmacy Services-PA METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67046-481_912e850f-a0bf-4e07-a800-43479eeffb05 67046-481 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20100630 ANDA ANDA076122 Contract Pharmacy Services-PA MIRTAZAPINE 15 mg/1 67046-482_912e850f-a0bf-4e07-a800-43479eeffb05 67046-482 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20100630 ANDA ANDA076122 Contract Pharmacy Services-PA MIRTAZAPINE 30 mg/1 67046-483_912e850f-a0bf-4e07-a800-43479eeffb05 67046-483 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20100630 ANDA ANDA076122 Contract Pharmacy Services-PA MIRTAZAPINE 45 mg/1 67046-489_bc6e059d-1951-4fa3-b904-230d4165724d 67046-489 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20100319 NDA NDA021487 Contract Pharmacy Services-PA MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] 67046-499_2c4f826c-e71b-4462-a025-19730701a9de 67046-499 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100319 ANDA ANDA078250 Contract Pharmacy Services-PA NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67046-500_2c4f826c-e71b-4462-a025-19730701a9de 67046-500 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100319 ANDA ANDA078250 Contract Pharmacy Services-PA NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67046-501_2c4f826c-e71b-4462-a025-19730701a9de 67046-501 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100319 ANDA ANDA078250 Contract Pharmacy Services-PA NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67046-515_43062486-bbac-47e4-bae1-16924338c8d8 67046-515 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100413 NDA NDA019684 Contract Pharmacy Services-PA NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 67046-520_ab5f9512-335f-4490-a6a9-12f611646991 67046-520 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20100309 ANDA ANDA075410 Contract Pharmacy Services-PA OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 67046-530_32fd11aa-2996-496d-ac3b-76a6afe22e3c 67046-530 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET, FILM COATED ORAL 20100811 ANDA ANDA077584 Contract Pharmacy Services-PA PAROXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-531_32fd11aa-2996-496d-ac3b-76a6afe22e3c 67046-531 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET, FILM COATED ORAL 20100811 ANDA ANDA077584 Contract Pharmacy Services-PA PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-532_32fd11aa-2996-496d-ac3b-76a6afe22e3c 67046-532 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET, FILM COATED ORAL 20100811 ANDA ANDA077584 Contract Pharmacy Services-PA PAROXETINE HYDROCHLORIDE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-533_32fd11aa-2996-496d-ac3b-76a6afe22e3c 67046-533 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET, FILM COATED ORAL 20100811 ANDA ANDA077584 Contract Pharmacy Services-PA PAROXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-535_7c958802-daad-4c7e-88eb-73be7d2261d8 67046-535 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20100226 NDA NDA020987 Contract Pharmacy Services-PA PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 67046-540_f2c7e54b-ed7c-4d8f-a86d-5099a8b52f28 67046-540 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20100407 ANDA ANDA089684 Contract Pharmacy Services-PA PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 67046-541_f2c7e54b-ed7c-4d8f-a86d-5099a8b52f28 67046-541 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20100407 ANDA ANDA089685 Contract Pharmacy Services-PA PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 67046-585_da966d98-94a6-463e-aff7-771406c4c836 67046-585 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20100406 ANDA ANDA040684 Contract Pharmacy Services-PA PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67046-588_dbd309c5-7205-41e3-b8c4-cb06df375528 67046-588 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20100802 ANDA ANDA074726 Contract Pharmacy Services-PA POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 67046-589_0c0a180b-f4f4-4122-9e29-ac7160a9f519 67046-589 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20100802 ANDA ANDA075604 Contract Pharmacy Services-PA POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 67046-590_dbd309c5-7205-41e3-b8c4-cb06df375528 67046-590 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20100802 ANDA ANDA074726 Contract Pharmacy Services-PA POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 67046-604_e5a90643-3f0e-45a2-a9a4-65229c38d6ab 67046-604 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 19990226 NDA NDA020839 Contract Pharmacy Services-PA CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 67046-640_82effea8-5782-4aa5-969e-b635423ae3c6 67046-640 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20101206 ANDA ANDA076228 Contract Pharmacy Services-PA RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 67046-641_82effea8-5782-4aa5-969e-b635423ae3c6 67046-641 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20101206 ANDA ANDA076228 Contract Pharmacy Services-PA RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 67046-642_82effea8-5782-4aa5-969e-b635423ae3c6 67046-642 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20101206 ANDA ANDA076228 Contract Pharmacy Services-PA RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 67046-643_82effea8-5782-4aa5-969e-b635423ae3c6 67046-643 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20101206 ANDA ANDA076228 Contract Pharmacy Services-PA RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 67046-644_82effea8-5782-4aa5-969e-b635423ae3c6 67046-644 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20101206 ANDA ANDA076228 Contract Pharmacy Services-PA RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 67046-645_82effea8-5782-4aa5-969e-b635423ae3c6 67046-645 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20101206 ANDA ANDA076228 Contract Pharmacy Services-PA RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 67046-650_d79fa307-a4fa-4ded-af53-31df482510dc 67046-650 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20100311 ANDA ANDA075180 Contract Pharmacy Services-PA RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 67046-651_a0a40104-2196-4ea2-9577-63b86d6acb65 67046-651 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20100630 ANDA ANDA077824 Contract Pharmacy Services-PA RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 67046-653_2e5c6b7f-1d57-4114-9067-79dca009c4cc 67046-653 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20100825 ANDA ANDA078040 Contract Pharmacy Services-PA RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 67046-654_2e5c6b7f-1d57-4114-9067-79dca009c4cc 67046-654 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20100825 ANDA ANDA078040 Contract Pharmacy Services-PA RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 67046-655_2e5c6b7f-1d57-4114-9067-79dca009c4cc 67046-655 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20100825 ANDA ANDA078040 Contract Pharmacy Services-PA RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 67046-656_2e5c6b7f-1d57-4114-9067-79dca009c4cc 67046-656 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20100825 ANDA ANDA078040 Contract Pharmacy Services-PA RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 67046-657_2e5c6b7f-1d57-4114-9067-79dca009c4cc 67046-657 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20100825 ANDA ANDA078040 Contract Pharmacy Services-PA RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 67046-658_2e5c6b7f-1d57-4114-9067-79dca009c4cc 67046-658 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20100825 ANDA ANDA078040 Contract Pharmacy Services-PA RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 67046-660_276e53bf-d3c0-4457-a76e-ee39c1cd2a3d 67046-660 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 67046-661_276e53bf-d3c0-4457-a76e-ee39c1cd2a3d 67046-661 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 67046-662_276e53bf-d3c0-4457-a76e-ee39c1cd2a3d 67046-662 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 67046-663_276e53bf-d3c0-4457-a76e-ee39c1cd2a3d 67046-663 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 67046-664_276e53bf-d3c0-4457-a76e-ee39c1cd2a3d 67046-664 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 67046-665_3e2cb0ae-2284-44d0-9eff-f7d4ab6501a5 67046-665 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 20100315 NDA NDA019839 Contract Pharmacy Services-PA SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67046-666_276e53bf-d3c0-4457-a76e-ee39c1cd2a3d 67046-666 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 67046-670_727b02f3-bcd1-4568-9a0d-7723b6264800 67046-670 HUMAN OTC DRUG Senna-S docusate sodium and sennosides TABLET, FILM COATED ORAL 20100817 OTC MONOGRAPH NOT FINAL part334 Contract Pharmacy Services-PA DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 67046-671_13c80d46-429e-4007-8f89-eed2ed96eccf 67046-671 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20100617 ANDA ANDA077752 Contract Pharmacy Services-PA SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 67046-672_7fce939e-c38e-497f-ba3f-e7b6ba44bfd9 67046-672 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20100825 ANDA ANDA077837 Contract Pharmacy Services-PA SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 67046-674_13c80d46-429e-4007-8f89-eed2ed96eccf 67046-674 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20100617 ANDA ANDA077752 Contract Pharmacy Services-PA SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 67046-675_7fce939e-c38e-497f-ba3f-e7b6ba44bfd9 67046-675 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20100825 ANDA ANDA077837 Contract Pharmacy Services-PA SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 67046-714_dff887ee-43c7-40fc-9c5f-76014616c461 67046-714 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20110114 ANDA ANDA090828 Contract Pharmacy Services-PA SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 67046-715_a03f40f5-068e-41f2-826d-6ed627dd8776 67046-715 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100406 ANDA ANDA078060 Contract Pharmacy Services-PA SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 67046-720_7350ad6e-7745-4743-9aa4-2a14ff01fef4 67046-720 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100728 ANDA ANDA078225 Contract Pharmacy Services-PA TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 67046-728_13a23307-61e4-4094-9132-68e38d200d18 67046-728 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20100315 ANDA ANDA060704 Contract Pharmacy Services-PA TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 67046-730_a1527d3b-85a5-4588-8ce3-533ecb48ab7f 67046-730 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20100226 ANDA ANDA076003 Contract Pharmacy Services-PA TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 67046-739_4e0ce52d-2639-42a2-a4e4-7854421fa1b6 67046-739 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20100811 ANDA ANDA072192 Contract Pharmacy Services-PA TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 67046-740_28080f0c-0b6c-4d95-8a53-6474bb876b0e 67046-740 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochoride TABLET ORAL 20100309 ANDA ANDA071523 Contract Pharmacy Services-PA TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 67046-741_28080f0c-0b6c-4d95-8a53-6474bb876b0e 67046-741 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20100309 ANDA ANDA071524 Contract Pharmacy Services-PA TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 67046-742_4e0ce52d-2639-42a2-a4e4-7854421fa1b6 67046-742 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20100811 ANDA ANDA072193 Contract Pharmacy Services-PA TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 67046-805_6541ab19-3cfc-4786-9cfe-0455f428edb5 67046-805 HUMAN PRESCRIPTION DRUG Valproic Valproic Acid CAPSULE, LIQUID FILLED ORAL 20100405 ANDA ANDA073484 Contract Pharmacy Services-PA VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 67046-806_9fbfe4dc-c4df-4911-a440-099c860cb923 67046-806 HUMAN PRESCRIPTION DRUG Valproic Valproic Acid CAPSULE, LIQUID FILLED ORAL 20100405 ANDA ANDA073229 Contract Pharmacy Services-PA VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 67046-901_17b567bb-05c1-4309-b8ea-59009f08abd5 67046-901 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20100216 ANDA ANDA040419 Contract Pharmacy Services-PA ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII 67046-902_078eac0c-1589-4c6e-96ca-7543a4c1277e 67046-902 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 Contract Pharmacy Services-PA ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII 67046-906_7abac94c-ba0e-415b-9196-72caf153cc7c 67046-906 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20110329 ANDA ANDA071858 Contract Pharmacy Services-PA CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67046-910_720bb488-30df-4eca-8b5d-87b73272a509 67046-910 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20100407 ANDA ANDA084769 Contract Pharmacy Services-PA CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67046-915_52a03dbc-0510-40ec-8a33-15bf1c404622 67046-915 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20100701 ANDA ANDA074869 Contract Pharmacy Services-PA CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67046-917_52a03dbc-0510-40ec-8a33-15bf1c404622 67046-917 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20100701 ANDA ANDA074869 Contract Pharmacy Services-PA CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67046-919_52a03dbc-0510-40ec-8a33-15bf1c404622 67046-919 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20100701 ANDA ANDA074869 Contract Pharmacy Services-PA CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67046-925_e45a941e-4f98-43ca-adae-9e1c02f949e4 67046-925 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20110218 ANDA ANDA089883 Contract Pharmacy Services-PA ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67046-926_ab6b4c39-b2d4-4c63-8821-b0560f781287 67046-926 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA089160 Contract Pharmacy Services-PA ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67046-927_deaf83c4-6df1-4f11-82cc-9fed561e8b40 67046-927 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040729 Contract Pharmacy Services-PA ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67046-928_2ebcbba3-36bb-49ec-8625-43d60fb730ee 67046-928 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19881202 ANDA ANDA089971 Contract Pharmacy Services-PA ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67046-941_59f7ce6d-5811-40cc-900e-47a5fdb42a98 67046-941 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20110801 ANDA ANDA071135 Contract Pharmacy Services-PA DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67046-942_59f7ce6d-5811-40cc-900e-47a5fdb42a98 67046-942 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20110329 ANDA ANDA071136 Contract Pharmacy Services-PA DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67046-950_e8e1b3d7-0272-4278-b2a3-1d10dbeb0a5a 67046-950 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20030201 UNAPPROVED DRUG OTHER Contract Pharmacy Services-PA PHENOBARBITAL 32.4 mg/1 CIV 67046-953_e8e1b3d7-0272-4278-b2a3-1d10dbeb0a5a 67046-953 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20011201 UNAPPROVED DRUG OTHER Contract Pharmacy Services-PA PHENOBARBITAL 64.8 mg/1 CIV 67046-960_366500a0-6e91-4aaf-802a-8966b1c5a3e5 67046-960 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20110325 ANDA ANDA074112 Contract Pharmacy Services-PA ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67046-961_366500a0-6e91-4aaf-802a-8966b1c5a3e5 67046-961 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20110325 ANDA ANDA074112 Contract Pharmacy Services-PA ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67046-962_366500a0-6e91-4aaf-802a-8966b1c5a3e5 67046-962 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20110325 ANDA ANDA074112 Contract Pharmacy Services-PA ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67046-963_c4520457-0b0e-493f-805c-c04a788268ee 67046-963 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Contract Pharmacy Services-PA ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67046-964_c4520457-0b0e-493f-805c-c04a788268ee 67046-964 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Contract Pharmacy Services-PA ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67046-965_c4520457-0b0e-493f-805c-c04a788268ee 67046-965 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Contract Pharmacy Services-PA ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67046-980_0209bb1e-b8fa-4fa9-a533-4dda028bd369 67046-980 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110329 ANDA ANDA071403 Contract Pharmacy Services-PA LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67046-981_0209bb1e-b8fa-4fa9-a533-4dda028bd369 67046-981 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110329 ANDA ANDA071404 Contract Pharmacy Services-PA LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67046-982_0209bb1e-b8fa-4fa9-a533-4dda028bd369 67046-982 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110329 ANDA ANDA071141 Contract Pharmacy Services-PA LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67091-119_2e5464d2-84ae-4a29-93e9-402e772da4ef 67091-119 HUMAN OTC DRUG Childrens Pain Relief Dye-Free Acteaminophen SUSPENSION ORAL 20141212 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ACETAMINOPHEN 160 mg/5mL 67091-120_0d1ac3ab-f454-4d2a-840a-1416056a7545 67091-120 HUMAN OTC DRUG Childrens Pain Relief Dye-Free Acteaminophen SUSPENSION ORAL 20141212 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ACETAMINOPHEN 160 mg/5mL 67091-121_5beb16ed-aa93-4f93-9538-c0a071eb6346 67091-121 HUMAN OTC DRUG Infants Pain Relief Dye-Free Acteaminophen SUSPENSION ORAL 20141212 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ACETAMINOPHEN 160 mg/5mL 67091-142_f7378fc3-332a-402e-8b5d-3f7caf80bed8 67091-142 HUMAN OTC DRUG WinCo Foods Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20141126 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 67091-143_61f8b3ab-ca35-497f-a163-87b909eca797 67091-143 HUMAN OTC DRUG WinCo Foods Nighttime Severe Cold and Cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20141126 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 67091-180_7d698427-dafa-4598-922d-b9a201c2ec1e 67091-180 HUMAN OTC DRUG WinCo Foods Hypoallergenic Benzalkonium chloride CLOTH TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part333A WinCo Foods, LLC BENZALKONIUM CHLORIDE .115 g/1 67091-191_4f2ca6d9-400a-439a-be9a-37879650f0a9 67091-191 HUMAN OTC DRUG WinCo Foods Extra Moisturizing Nasal Relief Oxymetazoline HCL SPRAY NASAL 20141126 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC OXYMETAZOLINE HYDROCHLORIDE .005 g/100mL 67091-192_93f6157e-b479-448a-9aba-21b461a44c8c 67091-192 HUMAN OTC DRUG WinCo Foods Severe Congestion Nasal Relief Oxymetazoline HCL SPRAY NASAL 20141201 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 67091-193_70dd3aef-3b10-4c0b-a720-a28fadcf299e 67091-193 HUMAN OTC DRUG WinCo Foods Original Nasal Oxymetazoline HCL SPRAY NASAL 20141126 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 67091-194_c388fdf8-b62e-4be8-81b1-6ffd4f58958c 67091-194 HUMAN OTC DRUG WinCo Foods Saline Nasal Sodium Chloride SPRAY NASAL 20141126 OTC MONOGRAPH FINAL part349 WinCo Foods, LLC SODIUM CHLORIDE .65 g/100mL 67091-195_2a97b2e5-71d9-4c57-9037-698c8accbad7 67091-195 HUMAN OTC DRUG WinCo Foods Maximum Strength Acne Treatment Benzoyl peroxide CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part333D WinCo Foods, LLC BENZOYL PEROXIDE 10 g/100g 67091-198_6afa8c40-efa6-45fe-902a-c85596159a36 67091-198 HUMAN OTC DRUG WinCo Foods Maximum Strength Oral Analgesic Benzocaine GEL TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part356 WinCo Foods, LLC BENZOCAINE 200 mg/g 67091-218_994d9096-a622-493d-b128-9509d0629dc9 67091-218 HUMAN OTC DRUG Infants Gas Relief Drops simethicone EMULSION ORAL 20141124 OTC MONOGRAPH FINAL part332 WinCo Foods, LLC DIMETHICONE 20 mg/.3mL 67091-219_1221d072-35cc-4aae-b5fe-e6591b881077 67091-219 HUMAN OTC DRUG Childrens Allergy Relief Dye Free Cherry Diphenhydramine HCl LIQUID ORAL 20141212 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 67091-220_0cf27702-8bc4-4713-9700-61cb386e2931 67091-220 HUMAN OTC DRUG Childrens Multi-symptom Cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141212 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL 67091-221_b3474b52-7894-4762-a4f8-b11160f4adc6 67091-221 HUMAN OTC DRUG Childrens Multi-Symptom Cold and Fever Relief Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141212 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL 67091-222_59c09459-35e7-4a29-905d-e38df277ee8d 67091-222 HUMAN OTC DRUG Fiber Psyllium Husk CAPSULE ORAL 20141212 OTC MONOGRAPH NOT FINAL part334 WinCo Foods, LLC PSYLLIUM HUSK .52 g/1 67091-224_8203a070-053f-458f-b5a2-68467da607de 67091-224 HUMAN OTC DRUG Antacid calcium carbonate TABLET, CHEWABLE ORAL 20141212 OTC MONOGRAPH FINAL part331 WinCo Foods, LLC CALCIUM CARBONATE 500 mg/1 67091-225_1f83fc6e-b40d-4b68-a159-3d1731a260cc 67091-225 HUMAN OTC DRUG Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20141212 OTC MONOGRAPH FINAL part331 WinCo Foods, LLC CALCIUM CARBONATE 500 mg/1 67091-226_6b20d593-562b-48c8-96f7-4974ccfa43a2 67091-226 HUMAN OTC DRUG Antacid Ultra Strength Assorted Berries Calcium carbonate TABLET, CHEWABLE ORAL 20141212 OTC MONOGRAPH FINAL part331 WinCo Foods, LLC CALCIUM CARBONATE 1000 mg/1 67091-227_66d928cf-89c7-40f2-aca2-f6fa34da0e55 67091-227 HUMAN OTC DRUG Antacid Extra Strength Assorted Berries Calcium carbonate TABLET, CHEWABLE ORAL 20141212 OTC MONOGRAPH FINAL part331 WinCo Foods, LLC CALCIUM CARBONATE 750 mg/1 67091-228_28c197e4-24ab-4278-8457-56ce75aafebf 67091-228 HUMAN OTC DRUG Antacid Extra Strength Assorted Fruit Calcium antacid TABLET, CHEWABLE ORAL 20141212 OTC MONOGRAPH FINAL part331 WinCo Foods, LLC CALCIUM CARBONATE 750 mg/1 67091-229_9ef5ee3a-feb8-42fb-80e6-9a46d89291af 67091-229 HUMAN OTC DRUG Antacid Extra Strength Assorted Fruit Calcium antacid TABLET, CHEWABLE ORAL 20141212 OTC MONOGRAPH FINAL part331 WinCo Foods, LLC CALCIUM CARBONATE 750 mg/1 67091-232_0902418a-788d-4335-9d91-ecbccbae8710 67091-232 HUMAN OTC DRUG Gas Relief Extra Strength Cherry simethicone TABLET, CHEWABLE ORAL 20141212 OTC MONOGRAPH FINAL part332 WinCo Foods, LLC DIMETHICONE 125 mg/1 67091-233_79312415-f737-4482-9344-acd747f4e126 67091-233 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate LIQUID ORAL 20141212 OTC MONOGRAPH FINAL part335 WinCo Foods, LLC BISMUTH SUBSALICYLATE 262 mg/15mL 67091-234_61b94eed-aada-4453-8659-4d9f57705d0b 67091-234 HUMAN OTC DRUG Maximum strength Stomach Relief Bismuth Subsalicylate LIQUID ORAL 20141212 OTC MONOGRAPH FINAL part335 WinCo Foods, LLC BISMUTH SUBSALICYLATE 525 mg/15mL 67091-235_ceb15e78-59ec-4b59-b5e8-7703524562cd 67091-235 HUMAN OTC DRUG Stomach Relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20141212 OTC MONOGRAPH FINAL part335 WinCo Foods, LLC BISMUTH SUBSALICYLATE 262 mg/1 67091-239_d5251391-32d1-4c0f-9cd4-b0b9bb0e71b0 67091-239 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 WinCo Foods, LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 67091-240_d5251391-32d1-4c0f-9cd4-b0b9bb0e71b0 67091-240 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 WinCo Foods, LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 67091-241_d622b654-bd85-4da9-aeaa-3c6a362e5b0b 67091-241 HUMAN OTC DRUG Famotidine - Acid Controller Famotidine TABLET, FILM COATED ORAL 20120501 ANDA ANDA090283 WinCo Foods, LLC FAMOTIDINE 20 mg/1 67091-242_d622b654-bd85-4da9-aeaa-3c6a362e5b0b 67091-242 HUMAN OTC DRUG Famotidine - Acid Controller Famotidine TABLET, FILM COATED ORAL 20120501 ANDA ANDA090283 WinCo Foods, LLC FAMOTIDINE 10 mg/1 67091-243_6fb74c00-4901-4cd0-87d7-7c14b4fb14e1 67091-243 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20120815 ANDA ANDA200536 WinCo Foods, LLC RANITIDINE HYDROCHLORIDE 150 mg/1 67091-244_70bc7062-ab3c-43eb-b524-0d8c6d1a674d 67091-244 HUMAN OTC DRUG Acid Reducer Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20120802 ANDA ANDA201745 WinCo Foods, LLC RANITIDINE HYDROCHLORIDE 75 mg/1 67091-247_75838b78-8a5d-4f35-8be1-76d398cf1c9a 67091-247 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20120120 ANDA ANDA077498 WinCo Foods, LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 67108-3565_cd5d24e5-8c35-46d9-9a9c-4840f474ff19 67108-3565 HUMAN PRESCRIPTION DRUG MESNEX MESNA TABLET, FILM COATED ORAL 20020321 NDA NDA020855 Baxter Healthcare Corporation MESNA 400 mg/1 Cytoprotective Agent [EPC] 67112-101_5a06c2d0-a77e-43c0-b518-c4f2ff8be784 67112-101 HUMAN PRESCRIPTION DRUG TRICARE PRENATAL ASCORBIC ACID, CHOLECALCIFEROL, DL-.ALPHA.-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARAT TABLET, COATED ORAL 20021111 UNAPPROVED DRUG OTHER Medecor Pharma, LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; ZINC OXIDE 30; 100; 200; 400; 2; 12; 27; 1; 20; 3.1; 1.6; 1.6; 10 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 67112-101_964fa59a-d227-49d3-966a-2e64fedca709 67112-101 HUMAN PRESCRIPTION DRUG TRICARE PRENATAL ASCORBIC ACID, CHOLECALCIFEROL, DL-.ALPHA.-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARAT TABLET, COATED ORAL 20120101 UNAPPROVED DRUG OTHER Medecor Pharma, LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; ZINC OXIDE 30; 100; 200; 400; 2; 12; 27; 1; 20; 3.1; 1.6; 1.6; 10 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 67112-401_55378cfe-01a7-4c13-9469-2d652698964c 67112-401 HUMAN PRESCRIPTION DRUG TRICARE PRENATAL DHA ONE MULTIVITAMIN/MINERAL CAPSULE, GELATIN COATED ORAL 20100113 UNAPPROVED DRUG OTHER Medecor Pharma, LLC ALPHA-TOCOPHEROL, D-; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CUPRIC SULFATE ANHYDROUS; CYANOCOBALAMIN; DOCONEXENT; DOCUSATE SODIUM; FERROUS FUMARATE; FISH OIL; FOLIC ACID; ICOSAPENT; INOSITOL NIACINATE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC SULFATE MONOHYDRATE 30; 60; 300; 800; 2; 100; 215; 25; 27; 500; 1; 45; 20; 25; 3.4; 3; 10 [iU]/1; mg/1; ug/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 67112-401_78462d8d-122c-48c9-b9b9-395974d833eb 67112-401 HUMAN PRESCRIPTION DRUG TRICARE PRENATAL DHA ONE FISH OIL, DOCONEXENT, ICOSAPENT, THIAMINE MONONITRATE, RIBOFLAVIN, INOSITOL NIACINATE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, FOLIC ACID, ASCORBIC ACID, CHOLECALCIFEROL, D-ALPHA-TOCOPHEROL, BIOTIN, CAPSULE, GELATIN COATED ORAL 20120101 UNAPPROVED DRUG OTHER Medecor Pharma, LLC ALPHA-TOCOPHEROL, D-; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CUPRIC SULFATE ANHYDROUS; CYANOCOBALAMIN; DOCONEXENT; DOCUSATE SODIUM; FERROUS FUMARATE; FISH OIL; FOLIC ACID; ICOSAPENT; INOSITOL NIACINATE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC SULFATE MONOHYDRATE 30; 60; 300; 800; 2; 100; 215; 25; 27; 500; 1; 45; 20; 25; 3.4; 3; 10 [iU]/1; mg/1; ug/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 67112-501_5b37f2b7-8dba-4d41-a535-d4517013587a 67112-501 HUMAN PRESCRIPTION DRUG TRICARE PRENATAL COMPLEAT KIT ESSENTIAL FATTY ACIDS, MULTIVITAMINS, MINERALS KIT 20130321 UNAPPROVED DRUG OTHER Medecor Pharma, LLC 67138-533_86239ca0-709d-45e4-97b1-c185dc945efb 67138-533 HUMAN OTC DRUG Polar Frost Cold Menthol GEL TOPICAL 20021111 OTC MONOGRAPH NOT FINAL part348 Mettler Electronics Corp. MENTHOL 40 mg/mL 67143-0100_71c70eda-c2a8-4a59-9470-4db06c51280f 67143-0100 HUMAN OTC DRUG Dermasil Advanced dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL 67143-0101_c4e2b772-dbfe-443b-99a3-7bf1dd1b16a0 67143-0101 HUMAN OTC DRUG Dermasil dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL 67143-0102_ff7d39c0-75f6-443b-899e-4bfd3f058050 67143-0102 HUMAN OTC DRUG Dermasil Sensitive dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL 67143-1100_ff061e46-2b45-44a7-92c8-7bf28e41efdd 67143-1100 HUMAN OTC DRUG Dermasil Advanced dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL 67143-2100_052f3034-1f54-472e-915d-f3b2eb23cdd3 67143-2100 HUMAN OTC DRUG Dermasil Advanced dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL 67143-2101_b3f36982-ea69-4add-a392-7beac82b7245 67143-2101 HUMAN OTC DRUG Dermasil Dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL 67143-2101_b6eb8c3f-5c7c-443b-9a8d-a602652adfe3 67143-2101 HUMAN OTC DRUG Dermasil dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL 67143-2102_b4a5bc77-01cb-44b0-b0ba-2c58d7645e3d 67143-2102 HUMAN OTC DRUG Dermasil Sensitive dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL 67143-3102_29d0c5f0-fa5a-4d89-a123-63cbea6c8587 67143-3102 HUMAN OTC DRUG Dermasil Sensitive dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL 67147-221_6e737375-cf4a-4271-b222-3c350a1542f7 67147-221 HUMAN OTC DRUG Hanitizer ALCOHOL GEL TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333E Apple Products, Inc. ALCOHOL .7 mL/mL 67147-544_19520d37-fd12-4727-a056-a82e5df86d36 67147-544 HUMAN OTC DRUG Pro-Care CHLOROXYLENOL SOAP TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333E Apple Products, Inc. CHLOROXYLENOL .003 mL/mL 67147-576_668fb3b4-2658-45ec-a01c-aef3caa51813 67147-576 HUMAN OTC DRUG DermaCare TRICLOSAN SOAP TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333E Apple Products, Inc. TRICLOSAN .003 mL/mL 67147-585_b8a35dcd-dba7-46d8-91f7-79c09b97eb87 67147-585 HUMAN OTC DRUG Al CaFoam ALCOHOL LIQUID TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333E Apple Products, Inc. ALCOHOL .7 mL/mL 67147-855_be49866d-0c0b-463a-8ba3-a1c684e44588 67147-855 HUMAN OTC DRUG Al CaFoam ALCOHOL LIQUID TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333E Apple Products, Inc. ALCOHOL .62 mL/mL 67151-303_ca5a8530-8187-40f8-9f80-daf97623758f 67151-303 HUMAN OTC DRUG Wipes Plus Benzalkonium Chloride SWAB TOPICAL 20120111 OTC MONOGRAPH FINAL part333E Progressive Products, LLC BENZALKONIUM CHLORIDE .0062 g/1 67151-404_df2d617d-26bb-4702-9efd-5cf9133f3950 67151-404 HUMAN OTC DRUG Alcohol Alcohol SWAB TOPICAL 20140607 OTC MONOGRAPH NOT FINAL part356 Progressive Products, LLC ALCOHOL 1.31 g/1 67152-001_e9e4bdc1-36e0-41e7-892f-007bbeaebabb 67152-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20101028 UNAPPROVED MEDICAL GAS Two MP Investments, Inc. dba Respicare OXYGEN 1 L/L 67172-011_a168aa95-402e-4476-ba95-f267d4d86684 67172-011 HUMAN OTC DRUG Chloraseptic Sore Throat Liquid Center Menthol and Benzocaine LOZENGE ORAL 20100801 OTC MONOGRAPH FINAL part341 Prestige Brands Holdings, Inc. BENZOCAINE; MENTHOL 6; 10 mg/1; mg/1 67172-012_a168aa95-402e-4476-ba95-f267d4d86684 67172-012 HUMAN OTC DRUG Chloraseptic Sore Throat Liquid Center Menthol and Benzocaine LOZENGE ORAL 20100801 OTC MONOGRAPH FINAL part341 Prestige Brands Holdings, Inc. BENZOCAINE; MENTHOL 6; 10 mg/1; mg/1 67172-013_a168aa95-402e-4476-ba95-f267d4d86684 67172-013 HUMAN OTC DRUG Chloraseptic Sore Throat Liquid Center Menthol and Benzocaine LOZENGE ORAL 20100801 OTC MONOGRAPH FINAL part341 Prestige Brands Holdings, Inc. BENZOCAINE; MENTHOL 6; 10 mg/1; mg/1 67172-014_cad8e141-a8c9-4868-81a2-074955088206 67172-014 HUMAN OTC DRUG Chloraseptic Sore Throat Liquid Center Menthol and Benzocaine LOZENGE ORAL 20100801 OTC MONOGRAPH FINAL part341 Prestige Brands Holdings, Inc. BENZOCAINE; MENTHOL 6; 10 mg/1; mg/1 67172-015_512b4cc3-ed37-43e8-b57e-754678da845b 67172-015 HUMAN OTC DRUG Chloraseptic Sore Throat Liquid Center Menthol and Benzocaine and Dextromethorphan Hydrobromide LOZENGE ORAL 20100801 OTC MONOGRAPH FINAL part356 Prestige Brands Holdings, Inc. BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL 6; 5; 10 mg/1; mg/1; mg/1 67172-016_2ea435c4-5440-4872-9f1e-2e795d9a6812 67172-016 HUMAN OTC DRUG Chloraseptic Sore Throat Liquid Center Menthol and Benzocaine and Dextromethorphan Hydrobromide LOZENGE ORAL 20100801 OTC MONOGRAPH FINAL part356 Prestige Brands Holdings, Inc. BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL 6; 5; 10 mg/1; mg/1; mg/1 67172-017_ce1ccd55-680c-4854-af4c-19b71b44ec58 67172-017 HUMAN OTC DRUG Chloraseptic Warming Sore Throat Benzocaine LOZENGE ORAL 20120101 OTC MONOGRAPH FINAL part346 Prestige Brands Holdings, Inc. BENZOCAINE 15 mg/1 67172-018_ce1ccd55-680c-4854-af4c-19b71b44ec58 67172-018 HUMAN OTC DRUG Chloraseptic Warming Sore Throat Benzocaine LOZENGE ORAL 20120901 OTC MONOGRAPH FINAL part346 Prestige Brands Holdings, Inc. BENZOCAINE 15 mg/1 67172-111_7c8fdecf-8f84-4519-8548-670a2421435d 67172-111 HUMAN OTC DRUG Chloraseptic Sore Throat Cherry Phenol SPRAY ORAL 20100901 OTC MONOGRAPH FINAL part348 Prestige Brands Holdings, Inc. PHENOL 3.5 mg/.7mL 67172-112_7c8fdecf-8f84-4519-8548-670a2421435d 67172-112 HUMAN OTC DRUG Chloraseptic Sore Throat Citrus Phenol SPRAY ORAL 20100901 OTC MONOGRAPH FINAL part348 Prestige Brands Holdings, Inc. PHENOL 3.5 mg/.7mL 67172-113_7c8fdecf-8f84-4519-8548-670a2421435d 67172-113 HUMAN OTC DRUG Chloraseptic Sore Throat Menthol Phenol SPRAY ORAL 20100901 OTC MONOGRAPH FINAL part348 Prestige Brands Holdings, Inc. PHENOL 3.5 mg/.7mL 67172-174_6c4af544-de64-4504-ae68-31b3e4d37c6d 67172-174 HUMAN OTC DRUG Chloraseptic Sore Throat Max Liquid Center Menthol and Benzocaine LOZENGE ORAL 20100801 OTC MONOGRAPH FINAL part341 Prestige Brands Holdings, Inc. BENZOCAINE; MENTHOL 15; 10 mg/1; mg/1 67172-181_543d8448-9ee6-4c1b-b692-bc470c502564 67172-181 HUMAN OTC DRUG Artificial Tears Lubricant Eye Polyvinyl Alcohol and Povidone LIQUID OPHTHALMIC 20120601 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. POLYVINYL ALCOHOL; POVIDONES 5; 6 mg/mL; mg/mL 67172-212_37119f1b-4200-46f1-ab35-6b6c8f6522cb 67172-212 HUMAN OTC DRUG Chloraseptic Warming Sore Throat Phenol SPRAY ORAL 20120701 OTC MONOGRAPH FINAL part348 Prestige Brands Holdings, Inc. PHENOL 3.5 mg/.7mL 67172-292_2f20039f-8632-48e4-a99c-25f4d9d7b9ba 67172-292 HUMAN OTC DRUG Clear Eyes Cooling Itchy Eye Relief Naphazoline Hydrochloride and Glycerin and Zinc Sulfate LIQUID OPHTHALMIC 20110215 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. GLYCERIN; NAPHAZOLINE HYDROCHLORIDE; ZINC SULFATE .0025; .00012; .0025 mg/mL; mg/mL; mg/mL 67172-393_c35cbbe6-ecca-4a42-9597-98b94630b3d1 67172-393 HUMAN OTC DRUG Clear Eyes Cooling Redness Relief Glycerin and Naphazoline Hydrochloride LIQUID OPHTHALMIC 20110215 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. GLYCERIN; NAPHAZOLINE HYDROCHLORIDE .0025; .00012 mg/mL; mg/mL 67172-494_ab8d8203-b50f-4b47-96f4-1eaff944eb37 67172-494 HUMAN OTC DRUG Clear Eyes Maximum Redness Relief Naphazoline Hydrochloride and Glycerin LIQUID OPHTHALMIC 20100901 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. GLYCERIN; NAPHAZOLINE HYDROCHLORIDE .0025; .00015 mL/mL; mg/mL 67172-557_b92d7564-cf9b-43e8-901a-f0b886492dbc 67172-557 HUMAN OTC DRUG Clear Eyes Natural Tears Polyvinyl alcohol and Povidone LIQUID OPHTHALMIC 20121001 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. POLYVINYL ALCOHOL; POVIDONES 5; 6 mg/mL; mg/mL 67172-574_4c67e61f-98cf-4f9f-a2d9-1a9571b8e464 67172-574 HUMAN OTC DRUG Murine Tears for Dry Eyes Polyvinyl Alcohol and Povidone LIQUID OPHTHALMIC 20121001 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. POLYVINYL ALCOHOL; POVIDONES .05; .06 mL/mL; mL/mL 67172-585_f640ef6f-b8b9-4172-b04f-f16591912496 67172-585 HUMAN OTC DRUG Clear Eyes Travelers Eye Relief Polyvinyl Alcohol and Povidone and Tetrahydrozoline Hydrochloride LIQUID OPHTHALMIC 20111115 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. POLYVINYL ALCOHOL; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .005; .006; .0005 mL/mL; mL/mL; mL/mL 67172-595_183db81c-7986-4626-88a6-341db9be25ce 67172-595 HUMAN OTC DRUG Clear Eyes Complete 7 Symptom Relief Hypromellose and Naphazoline Hydrochloride and Polysorbate 80 and Zinc Sulfate LIQUID OPHTHALMIC 20100301 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. HYPROMELLOSE; NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80; ZINC SULFATE .5; .0625; 1.25; .625 mL/mL; mL/mL; mL/mL; mL/mL 67172-686_def2a245-07e1-4550-89e3-2777d678fe30 67172-686 HUMAN OTC DRUG Clear Eyes Outdoor Dry Eye Protection Polyvinyl Alcohol and Povidone LIQUID OPHTHALMIC 20111115 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. POLYVINYL ALCOHOL; POVIDONE .075; .09 mL/mL; mL/mL 67172-696_d238336c-2e1c-4eea-80a4-d307ff408007 67172-696 HUMAN OTC DRUG Clear Eyes Maximum Redness Relief Naphazoline Hydrochloride and Glycerin LIQUID OPHTHALMIC 20100901 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. GLYCERIN; NAPHAZOLINE HYDROCHLORIDE .0025; .00015 mL/mL; mg/mL 67172-707_00de5b39-5db6-4089-8426-579eeb733946 67172-707 HUMAN OTC DRUG Clear Eyes Complete 7 Sympton Relief Hypromellose, Naphazoline Hydrochloride, Polysorbate 80 and Zinc Sulfate LIQUID OPHTHALMIC 20130612 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. HYPROMELLOSES; NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80; ZINC SULFATE .5; .0625; 1.25; .625 mg/mL; mg/mL; mg/mL; mg/mL 67172-797_88d8422b-1852-4947-b27b-43cc89c47668 67172-797 HUMAN OTC DRUG Clear Eyes Redness Relief Naphazoline Hydrochloride and Glycerin LIQUID OPHTHALMIC 20110427 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. GLYCERIN; NAPHAZOLINE HYDROCHLORIDE .0025; .00012 mL/mL; mL/mL 67172-898_8539c3d6-c842-4be8-92c7-4878e8804b5c 67172-898 HUMAN OTC DRUG Clear Eyes Triple Action Polyvinyl Alcohol and Povidone and Tetrahydrozoline Hydrochloride LIQUID OPHTHALMIC 20110315 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. POLYVINYL ALCOHOL; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .00125; .0015; .000125 mL/mL; mL/mL; mL/mL 67172-935_5403aab0-4cee-45b4-a466-ebee062133c9 67172-935 HUMAN OTC DRUG Chloraseptic Sore Throat Phenol SPRAY ORAL 20100901 OTC MONOGRAPH FINAL part348 Prestige Brands Holdings, Inc. PHENOL 3.5 mg/.7mL 67172-937_66632afd-d7f3-4b99-97e2-36a6d77e69b5 67172-937 HUMAN OTC DRUG Chloraseptic Sore Throat Max Phenol and Glycerin SPRAY ORAL 20110201 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. GLYCERIN; PHENOL 330; 15 mg/mL; mg/mL 67172-999_329e0d5f-8da7-4493-8e42-5e94f5e0b11e 67172-999 HUMAN OTC DRUG Clear Eyes Maximum Itchy Eye Relief Glycerin and Naphazoline Hydrochloride and Zinc Sulfate LIQUID OPHTHALMIC 20110315 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. GLYCERIN; NAPHAZOLINE HYDROCHLORIDE; ZINC SULFATE .625; .21; .625 mL/mL; mL/mL; mL/mL 67184-0507_16b0d44e-66e0-449a-ae5c-d9ec98c15051 67184-0507 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140908 ANDA ANDA203711 Qilu Pharmaceutical Co., Ltd. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 67191-001_15572093-1eb2-4cc3-b666-b33843a4c2b1 67191-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130222 UNAPPROVED MEDICAL GAS Clinical Medical Services Inc. OXYGEN 99 L/100L 67225-0001_f07e841e-c5bc-4c49-94ca-d34be80c1c16 67225-0001 HUMAN OTC DRUG Dental Clinic 2080 Cavity Protection Sodium Monofluorophosphate PASTE DENTAL 20121201 OTC MONOGRAPH FINAL part355 Aekyung Ind. Co., Ltd. SODIUM MONOFLUOROPHOSPHATE .156 g/120g 67225-0002_7ae81c2f-2d34-41af-b1d4-14e7dd554a37 67225-0002 HUMAN OTC DRUG Dental Clinic 2080 K Strong Winter Green SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20140516 OTC MONOGRAPH FINAL part355 Aekyung Ind. Co., Ltd. SODIUM FLUORIDE .1 g/100g 67225-0003_46dbc0b3-59e7-4459-8061-f4c275da7f76 67225-0003 HUMAN OTC DRUG Dental Clinic 2080 K Citrus Cool Mint SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20140516 OTC MONOGRAPH FINAL part355 Aekyung Ind. Co., Ltd. SODIUM FLUORIDE .1 g/100g 67226-1020_2a9195bf-1427-487f-bfb1-5f6b07ab9f40 67226-1020 HUMAN OTC DRUG SkinTX Medicated Acne Wash SALICYLIC ACID LIQUID TOPICAL 20110119 OTC MONOGRAPH FINAL part333D Vivier Pharma, Inc. SALICYLIC ACID 2 mL/100mL 67226-1040_0fbce541-7cea-4523-83b3-bc8ef2a066f2 67226-1040 HUMAN OTC DRUG Seequin 4 Hydroquinone LIQUID TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma, Inc. HYDROQUINONE 4 g/100mL 67226-2030_4083e597-c4aa-4b40-b462-d158942ca214 67226-2030 HUMAN OTC DRUG Vivierskin Sunscreen SPF 30 AVOBENZONE, OCTINOXATE, ENSULIZOLE LOTION TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part352 Vivier Pharma, Inc. AVOBENZONE; ENSULIZOLE; OCTINOXATE 2.5; 2; 5.5 mL/100mL; mL/100mL; mL/100mL 67226-2040_a85fc760-1d86-4ff1-9f3a-5299b309e85a 67226-2040 HUMAN OTC DRUG Clarite 4 Hydroquinone CREAM TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma, Inc. HYDROQUINONE 4 g/100mL 67226-2045_cac1d9bf-1138-41bd-9052-4ce24e5b0b6a 67226-2045 HUMAN OTC DRUG VivierSkin Sun Protection SPF 45 ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20110325 OTC MONOGRAPH NOT FINAL part352 Vivier Pharma, Inc. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 7.5; 4.8 mL/100mL; mL/100mL; mL/100mL 67226-2050_63523a9a-38ec-44bb-a664-4c1aa774d803 67226-2050 HUMAN OTC DRUG SkinTx Acne Treatment BENZOYL PEROXIDE LOTION TOPICAL 20111101 OTC MONOGRAPH FINAL part333D Vivier Pharma, Inc. BENZOYL PEROXIDE 50 mg/mL 67226-2130_cb894e36-ba10-41d6-83c2-1db2f65a1077 67226-2130 HUMAN OTC DRUG SkinTx Sunscreen SPF 30 AVOBENZONE, OCTINOXATE, ENSULIZOLE LOTION TOPICAL 20110322 OTC MONOGRAPH NOT FINAL part352 Vivier Pharma, Inc. AVOBENZONE; ENSULIZOLE; OCTINOXATE 2.5; 2; 5.5 mL/100mL; mL/100mL; mL/100mL 67226-2140_337cf88c-f17b-448e-a2a3-48924ce302be 67226-2140 HUMAN OTC DRUG Active 4 Hydroquinone CREAM TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma, Inc. HYDROQUINONE 4 g/100mL 67226-2145_1dc862f7-951c-4365-b0ad-a3f18de4a298 67226-2145 HUMAN OTC DRUG SkinTx Daily Defense SPF 45 ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20110321 OTC MONOGRAPH NOT FINAL part352 Vivier Pharma, Inc. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 7.8; 4.8 mL/100mL; mL/100mL; mL/100mL 67226-2230_1758e1b9-ee73-47d9-b941-d7b5e591adcf 67226-2230 HUMAN OTC DRUG TRIPLE PROTECTION BROAD SPECTRUM SUNSCREENSPF 30 SPF 30 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20101124 OTC MONOGRAPH NOT FINAL part352 VIVIER PHARMA INC TITANIUM DIOXIDE; ZINC OXIDE 100; 80 mg/mL; mg/mL 67226-2330_57618b68-238d-4a53-b7eb-fb5843f1e510 67226-2330 HUMAN OTC DRUG Physical Facial Block SPF 30 ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20060828 OTC MONOGRAPH NOT FINAL part352 Vivier Pharma, Inc. TITANIUM DIOXIDE; ZINC OXIDE 6; 4.8 g/100mL; g/100mL 67226-2620_a39e0e11-37aa-4e3a-a205-2ec1a5fcba3f 67226-2620 HUMAN OTC DRUG SEEQUIN 2 Hydroquinone LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma, Inc. HYDROQUINONE 2 g/100mL 67226-2621_0e845254-635d-49bd-b8fa-6aea1b542c2a 67226-2621 HUMAN OTC DRUG Advanced Skin Lightening Serum Hydroquinone LIQUID TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma, Inc. HYDROQUINONE 2 g/100mL 67226-2720_06d2f445-cbcb-42d6-89ac-7ac89ef85093 67226-2720 HUMAN OTC DRUG Activator Light Hydroquinone LOTION TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma, Inc. HYDROQUINONE 2 g/100mL 67226-2820_8e8a91b1-066e-4be5-b80a-ece34d5d71e7 67226-2820 HUMAN OTC DRUG Corrector Light Hydroquinone LOTION TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma, Inc. HYDROQUINONE 2 g/100mL 67226-3025_1272bba8-988a-49c7-a9d1-b2a0ff8bfbb5 67226-3025 HUMAN OTC DRUG SkinTx Acne Treatment System SALICYLIC ACID, BENZOYL PEROXIDE KIT TOPICAL 20110307 OTC MONOGRAPH FINAL part333D Vivier Pharma 67234-001_837de2d4-b8fa-46fe-8840-e46d912e6048 67234-001 HUMAN OTC DRUG Natureplex ZINC OXIDE OINTMENT TOPICAL 20050102 OTC MONOGRAPH FINAL part347 Natureplex LLC ZINC OXIDE 400 mg/g 67234-002_a8055722-b283-4fe5-a096-7050a770f9c2 67234-002 HUMAN OTC DRUG Muscle Rub Ultra Strength MENTHOL and METHYL SALICYLATE CREAM TOPICAL 20070102 OTC MONOGRAPH NOT FINAL part348 Natureplex LLC MENTHOL; METHYL SALICYLATE .01; .15 mg/g; mg/g 67234-007_4947cae6-11af-4edd-93d7-eacac8a2f99e 67234-007 HUMAN OTC DRUG Acne Treatment SALICYLIC ACID GEL TOPICAL 20070102 OTC MONOGRAPH FINAL part333D Natureplex LLC SALICYLIC ACID .005 mg/g 67234-008_fb8e209f-f13a-47a3-a39a-32df64c34e4a 67234-008 HUMAN OTC DRUG Anti Itch Maximum Relief Pramoxine Hydrochloride and Menthol CREAM TOPICAL 20080102 OTC MONOGRAPH NOT FINAL part347 Natureplex LLC MENTHOL; PRAMOXINE HYDROCHLORIDE 10; 10 mg/g; mg/g 67234-009_ff6f63aa-4a3d-401f-ab2f-f6d2950c4aae 67234-009 HUMAN OTC DRUG Athlete s Foot Afac Clotrimazole CREAM TOPICAL 20080122 OTC MONOGRAPH FINAL part333C Natureplex, LLC CLOTRIMAZOLE .01 g/g 67234-010_8cf7a124-7d5b-403b-b87d-b4e0a55181b3 67234-010 HUMAN OTC DRUG Natureplex Hydrocortisone Hydro Hydrocortisone CREAM TOPICAL 20080122 OTC MONOGRAPH NOT FINAL part348 Natureplex, LLC HYDROCORTISONE .01 g/g 67234-014_fbb5cfe0-5f1e-4eb7-8495-6436dfaf32a7 67234-014 HUMAN OTC DRUG PRO-EX Anti Fungal Clotrimazole CREAM TOPICAL 20080122 OTC MONOGRAPH FINAL part333C Natureplex, LLC CLOTRIMAZOLE .01 g/g 67234-020_e7083d33-afc1-4edd-b23c-8ff660c31b0c 67234-020 HUMAN OTC DRUG NATUREPLEX Enema (saline) ENEMA RECTAL 20100601 OTC MONOGRAPH NOT FINAL part334 Natureplex, LLC SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/133mL; g/133mL 67234-022_a2742167-6d66-4a98-9122-9b37d168b056 67234-022 HUMAN OTC DRUG Bella Flore POVIDONE-IODINE KIT 20120102 OTC MONOGRAPH NOT FINAL part333A Natureplex LLC 67234-023_55c36e01-b58d-4270-8b10-fadf793ada71 67234-023 HUMAN OTC DRUG Dermamine Extra Strength Itch Stopping DIPHENHYDRAMINE and ZINC ACETATE CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part348 Natureplex LLC DIPHENHYDRAMINE; ZINC ACETATE .02; .001 mg/g; U/g 67234-024_85545e30-a9a5-468d-94ce-f926d7df78f6 67234-024 HUMAN OTC DRUG Natureplex Hemorrhoidal WITCH HAZEL and PHENYLEPHRINE HYDROCHLORIDE GEL TOPICAL 20140318 OTC MONOGRAPH FINAL part346 Natureplex LLC PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .0025; .5 mg/g; mg/g 67234-025_09e338d3-26a3-4e68-9c8a-78a3c767b402 67234-025 HUMAN OTC DRUG Natureplex Hemorrhoidal GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, and PETROLATUM CREAM TOPICAL 20140301 OTC MONOGRAPH FINAL part346 Natureplex LLC GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE .144; .15; .0025; .1 mg/g; mg/g; mg/g; mg/g 67234-030_0da82214-074b-4e37-88fa-7583cd68fc50 67234-030 HUMAN OTC DRUG A and D Diaper Rash and Skin Protectant Lanolin and Petrolatum CREAM TOPICAL 20141112 OTC MONOGRAPH FINAL part347 Natureplex LLC LANOLIN; PETROLATUM .15; .53 mg/g; mg/g 67239-0201_548c1a4d-7487-4e48-8761-71f5bdfdbb48 67239-0201 HUMAN PRESCRIPTION DRUG MEPIVACAINE HYDROCHLORIDE Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA088387 Safco Dental Supply Co. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 67239-0202_c1d28174-f269-438d-a7b2-d3f88a90bf44 67239-0202 HUMAN OTC DRUG Topical Anesthetic Cherry Benzocaine GEL DENTAL 20120806 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g 67239-0203_bf706626-b8e6-4528-8416-ed846c8749f4 67239-0203 HUMAN OTC DRUG Topical Anesthetic Mint Benzocaine GEL DENTAL 20120806 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g 67239-0204_e5a4848d-a586-4b5f-bdf5-e9445e01c633 67239-0204 HUMAN OTC DRUG Topical Anesthetic Banana Benzocaine GEL DENTAL 20120806 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g 67239-0205_0b8e2094-efb7-438b-afac-6ddfb4f55203 67239-0205 HUMAN OTC DRUG Topical Anesthetic Pina Colada Benzocaine GEL DENTAL 20120806 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g 67239-0206_fe13be14-68f7-4250-93fa-280b7a1d5ac8 67239-0206 HUMAN OTC DRUG Topical Anesthetic Bubble Gum Benzocaine GEL DENTAL 20120806 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g 67239-0207_c052d058-c325-4ec7-988c-6584265e4917 67239-0207 HUMAN OTC DRUG Topical Anesthetic Strawberry Benzocaine GEL DENTAL 20120806 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g 67239-0208_a9a58fb8-869e-4862-ba7e-442da4cbec74 67239-0208 HUMAN OTC DRUG Topical Anesthetic Raspberry Benzocaine GEL DENTAL 20120806 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g 67239-0240_5dc32aee-6543-4f40-a857-978dc846bb5c 67239-0240 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088390 Safco Dental Supply Co EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE .01; 20 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 67253-011_befe82b9-e822-4917-9774-b4cbd0c66a1e 67253-011 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20140501 ANDA ANDA065330 DAVA Pharmaceuticals Inc CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 67253-012_c2e19cf4-d7cf-4adc-86de-0bc0144af88d 67253-012 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20140501 ANDA ANDA065337 DAVA Pharmaceuticals Inc CEFDINIR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 67253-013_c2e19cf4-d7cf-4adc-86de-0bc0144af88d 67253-013 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20140501 ANDA ANDA065337 DAVA Pharmaceuticals Inc CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 67253-100_11ad5e85-3bbc-49c7-a379-dbc3f49e2a09 67253-100 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 19970422 ANDA ANDA074833 DAVA Pharmaceuticals, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 67253-101_11ad5e85-3bbc-49c7-a379-dbc3f49e2a09 67253-101 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19971119 ANDA ANDA074946 DAVA Pharmaceuticals, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 67253-102_11ad5e85-3bbc-49c7-a379-dbc3f49e2a09 67253-102 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19971119 ANDA ANDA074946 DAVA Pharmaceuticals, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 67253-140_e1f82195-86fb-426c-8772-36d05c4a6f1a 67253-140 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19880225 ANDA ANDA062884 DAVA Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-141_e1f82195-86fb-426c-8772-36d05c4a6f1a 67253-141 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19880225 ANDA ANDA062881 DAVA Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-142_e1f82195-86fb-426c-8772-36d05c4a6f1a 67253-142 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin FOR SUSPENSION ORAL 19881125 ANDA ANDA062927 DAVA Pharmaceuticals, Inc. AMOXICILLIN 25 mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-143_e1f82195-86fb-426c-8772-36d05c4a6f1a 67253-143 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin FOR SUSPENSION ORAL 19881125 ANDA ANDA062927 DAVA Pharmaceuticals, Inc. AMOXICILLIN 50 mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-144_5f55a89f-a7ca-497f-a17c-f751431e2cfb 67253-144 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20140801 ANDA ANDA064076 DAVA Pharmaceuticals Inc AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-145_e1f82195-86fb-426c-8772-36d05c4a6f1a 67253-145 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET ORAL 20090715 ANDA ANDA065344 DAVA Pharmaceuticals, Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-146_5f55a89f-a7ca-497f-a17c-f751431e2cfb 67253-146 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20140801 ANDA ANDA065387 DAVA Pharmaceuticals Inc AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-147_5f55a89f-a7ca-497f-a17c-f751431e2cfb 67253-147 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20140801 ANDA ANDA065378 DAVA Pharmaceuticals Inc AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-148_5f55a89f-a7ca-497f-a17c-f751431e2cfb 67253-148 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20140801 ANDA ANDA065387 DAVA Pharmaceuticals Inc AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-149_5f55a89f-a7ca-497f-a17c-f751431e2cfb 67253-149 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20140801 ANDA ANDA065378 DAVA Pharmaceuticals Inc AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-150_5f55a89f-a7ca-497f-a17c-f751431e2cfb 67253-150 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20140801 ANDA ANDA064076 DAVA Pharmaceuticals Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-151_e1f82195-86fb-426c-8772-36d05c4a6f1a 67253-151 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, CHEWABLE ORAL 19960129 ANDA ANDA064139 DAVA Pharmaceuticals, Inc. AMOXICILLIN 125 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-152_e1f82195-86fb-426c-8772-36d05c4a6f1a 67253-152 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, CHEWABLE ORAL 19960129 ANDA ANDA064139 DAVA Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-180_1422ac93-067c-489b-9b95-17cd00303f4c 67253-180 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 19880225 ANDA ANDA062882 DAVA Pharmaceuticals, Inc. AMPICILLIN TRIHYDRATE 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-181_1422ac93-067c-489b-9b95-17cd00303f4c 67253-181 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 19880225 ANDA ANDA062882 DAVA Pharmaceuticals, Inc. AMPICILLIN TRIHYDRATE 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-182_4dd38d9b-c5cf-450a-8c78-0ba312bdbf6f 67253-182 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Trihydrate SUSPENSION ORAL 19890210 ANDA ANDA062982 DAVA Pharmaceuticals, Inc. AMPICILLIN TRIHYDRATE 25 mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-183_4dd38d9b-c5cf-450a-8c78-0ba312bdbf6f 67253-183 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Trihydrate SUSPENSION ORAL 19890210 ANDA ANDA062982 DAVA Pharmaceuticals, Inc. AMPICILLIN TRIHYDRATE 50 mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67253-191_0353c7a7-53e1-4628-8585-049afbc48c1b 67253-191 HUMAN PRESCRIPTION DRUG bicalutamide bicalutamide TABLET, FILM COATED ORAL 20090706 ANDA ANDA077973 Dava Pharmaceuticals, Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 67253-200_0168e983-9624-4d6a-a774-c3419e86aa69 67253-200 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062936 DAVA Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 250 mg/1 67253-201_0168e983-9624-4d6a-a774-c3419e86aa69 67253-201 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062935 DAVA Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 67253-202_0168e983-9624-4d6a-a774-c3419e86aa69 67253-202 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium FOR SOLUTION ORAL 20040201 ANDA ANDA062981 DAVA Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 25 mg/mL 67253-203_0168e983-9624-4d6a-a774-c3419e86aa69 67253-203 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium FOR SOLUTION ORAL 20040201 ANDA ANDA062981 DAVA Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 50 mg/mL 67253-231_d2dbfc48-063b-41c0-864c-2c9426ba89c1 67253-231 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20140801 ANDA ANDA065235 DAVA Pharmaceuticals Inc CEFPROZIL 250 mg/1 67253-232_d2dbfc48-063b-41c0-864c-2c9426ba89c1 67253-232 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20140801 ANDA ANDA065235 DAVA Pharmaceuticals Inc CEFPROZIL 500 mg/1 67253-233_d2dbfc48-063b-41c0-864c-2c9426ba89c1 67253-233 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20140801 ANDA ANDA065257 DAVA Pharmaceuticals Inc CEFPROZIL 125 mg/5mL 67253-234_d2dbfc48-063b-41c0-864c-2c9426ba89c1 67253-234 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20140801 ANDA ANDA065257 DAVA Pharmaceuticals Inc CEFPROZIL 250 mg/5mL 67253-263_1e22a445-fde5-40f8-846c-f20c77980a57 67253-263 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19880405 ANDA ANDA071783 DAVA Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 67253-264_1e22a445-fde5-40f8-846c-f20c77980a57 67253-264 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19880405 ANDA ANDA071784 DAVA Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 67253-265_1e22a445-fde5-40f8-846c-f20c77980a57 67253-265 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19880405 ANDA ANDA071785 DAVA Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 67253-320_9c4a4784-b063-4c8f-b915-aeb18cb149be 67253-320 HUMAN PRESCRIPTION DRUG METHOTREXATE METHOTREXATE TABLET ORAL 19531207 NDA NDA008085 DAVA Pharmaceuticals, Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 67253-380_8aeeea4b-69f2-48c3-acf5-205073b09bfa 67253-380 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20040610 ANDA ANDA076161 DAVA Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 67253-381_8aeeea4b-69f2-48c3-acf5-205073b09bfa 67253-381 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20040610 ANDA ANDA076161 DAVA Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 67253-382_8aeeea4b-69f2-48c3-acf5-205073b09bfa 67253-382 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20040610 ANDA ANDA076161 DAVA Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 67253-383_8aeeea4b-69f2-48c3-acf5-205073b09bfa 67253-383 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20040610 ANDA ANDA076161 DAVA Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 67253-388_5ee53b51-c671-4f26-b2b5-58d968095818 67253-388 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840911 ANDA ANDA062500 DAVA Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 50 mg/1 67253-389_5ee53b51-c671-4f26-b2b5-58d968095818 67253-389 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840911 ANDA ANDA062500 DAVA Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 67253-391_c16af9ab-f34b-4747-8cc9-a40231c5a6d3 67253-391 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 19840911 ANDA ANDA062505 DAVA Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 67253-460_6803013c-f287-4733-b6a4-b76411562abd 67253-460 HUMAN PRESCRIPTION DRUG GlyBURIDE GlyBURIDE TABLET ORAL 19971222 ANDA ANDA074591 DAVA Pharmaceuticals, Inc. GLYBURIDE 1.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 67253-461_6803013c-f287-4733-b6a4-b76411562abd 67253-461 HUMAN PRESCRIPTION DRUG GlyBURIDE GlyBURIDE TABLET ORAL 19971222 ANDA ANDA074591 DAVA Pharmaceuticals, Inc. GLYBURIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 67253-462_6803013c-f287-4733-b6a4-b76411562abd 67253-462 HUMAN PRESCRIPTION DRUG GlyBURIDE GlyBURIDE TABLET ORAL 19971222 ANDA ANDA074591 DAVA Pharmaceuticals, Inc. GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 67253-540_b75e6570-c96a-4362-b1e6-2690b859816a 67253-540 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19820727 NDA NDA018415 DAVA Pharmaceuticals, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 67253-541_b75e6570-c96a-4362-b1e6-2690b859816a 67253-541 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19820727 NDA NDA018415 DAVA Pharmaceuticals, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 67253-542_b75e6570-c96a-4362-b1e6-2690b859816a 67253-542 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19820727 NDA NDA018415 DAVA Pharmaceuticals, Inc. FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 67253-580_0cbea1d5-7849-4b0b-acbc-5bd5544759d0 67253-580 HUMAN PRESCRIPTION DRUG Rheumatrex Dose Pack Methotrexate TABLET ORAL 19530712 NDA NDA008085 DAVA Pharmaceuticals, Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 67253-651_981ee2a4-861b-49b5-a1ae-15c424b797cd 67253-651 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 20100129 NDA NDA006188 DAVA International Inc. PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 67253-660_6456d188-4ee2-4630-bffc-d41e04d17e53 67253-660 HUMAN PRESCRIPTION DRUG Pyrazinamide Pyrazinamide TABLET ORAL 19710603 ANDA ANDA080157 DAVA Pharmaceuticals, Inc. PYRAZINAMIDE 500 mg/1 Antimycobacterial [EPC] 67253-700_1506c0d8-a0a8-4917-9d38-a78244c172cc 67253-700 HUMAN PRESCRIPTION DRUG SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE CAPSULE ORAL 20061104 ANDA ANDA075352 DAVA Pharmaceuticals, Inc. SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] 67253-741_d746e4cb-a6b7-4d1c-8686-f435b03aa608 67253-741 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19930927 ANDA ANDA074270 DAVA Pharmaceuticals, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 67253-820_4d57a23d-ee3b-47ea-a823-4f28e90fb98a 67253-820 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19801105 ANDA ANDA087059 DAVA Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 67253-821_4d57a23d-ee3b-47ea-a823-4f28e90fb98a 67253-821 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19801105 ANDA ANDA087068 DAVA Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 67253-900_eba936b6-7a9f-46af-abee-5762e03c5801 67253-900 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 DAVA Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67253-901_eba936b6-7a9f-46af-abee-5762e03c5801 67253-901 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 DAVA Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67253-902_eba936b6-7a9f-46af-abee-5762e03c5801 67253-902 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 DAVA Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67253-903_eba936b6-7a9f-46af-abee-5762e03c5801 67253-903 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 DAVA Pharmaceuticals, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67253-940_e116c26e-09fe-4508-a16d-21380c0d8c00 67253-940 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20101101 ANDA ANDA077051 DAVA Pharmaceuticals, Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 67253-941_e116c26e-09fe-4508-a16d-21380c0d8c00 67253-941 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20101101 ANDA ANDA077051 DAVA Pharmaceuticals, Inc. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 67253-942_e116c26e-09fe-4508-a16d-21380c0d8c00 67253-942 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20101101 ANDA ANDA077051 DAVA Pharmaceuticals, Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 67253-943_e116c26e-09fe-4508-a16d-21380c0d8c00 67253-943 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20101101 ANDA ANDA077051 DAVA Pharmaceuticals, Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 67296-0016_63fa3273-38d3-4855-aa4d-a4ff5b572fd2 67296-0016 HUMAN PRESCRIPTION DRUG Hydrocodone Acetaminophen HYDROCODONE, ACETAMINOPHEN TABLET ORAL 20110303 ANDA ANDA081083 RedPharm Drug Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67296-0023_1d333c09-ee5d-4d2a-bf1e-a68b939794f7 67296-0023 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20100128 ANDA ANDA061926 RedPharm Drug Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67296-0041_3175135b-1d6e-4dab-bb21-ed2c73d4a963 67296-0041 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20101007 ANDA ANDA088628 RedPharm Drug Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 CIII 67296-0042_38ef1f00-b8c5-4070-b518-8a3396b694a4 67296-0042 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19880415 ANDA ANDA071194 RedPharm Drug Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67296-0053_c9a70da5-765d-4c5d-a80c-34856c88338e 67296-0053 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20070101 ANDA ANDA077797 RedPharm Drug Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 67296-0055_39e6ab5d-c74c-48c5-a9af-6af8d0e8c4e8 67296-0055 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20101207 ANDA ANDA088618 RedPharm Drug Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 67296-0104_59cf923a-4424-4cca-b1e3-5904e234e4d4 67296-0104 HUMAN PRESCRIPTION DRUG PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN propoxyphene napsylate and acetaminophen TABLET ORAL 20090608 ANDA ANDA075738 RedPharm Drug Inc. ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 650; 100 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 67296-0105_6be07b28-c93f-4ad3-97f9-861c540455ef 67296-0105 HUMAN PRESCRIPTION DRUG PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN propoxyphene napsylate and acetaminophen TABLET ORAL 20090608 ANDA ANDA075738 RedPharm Drug Inc. ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 650; 100 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 67296-0106_1404b726-4ca2-44df-91ce-afabe0525ce1 67296-0106 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20100712 ANDA ANDA074421 RedPharm Drug Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 67296-0122_cfb75e69-e5a4-4b51-ab3c-e0e4cfa4b709 67296-0122 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 20110120 ANDA ANDA062286 RedPharm Drug Inc. DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67296-0140_c7dc85a9-193a-4f03-983d-1f6c8da6537e 67296-0140 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA085162 RedPharm Drug Inc. PREDNISONE 10 mg/1 67296-0152_291ca54c-dadb-4e47-abb3-8f937ab6ef08 67296-0152 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20100701 ANDA ANDA088496 RedPharm Drug Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 67296-0154_4c8fe3c9-0537-4fda-aef5-918f0a961a8b 67296-0154 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride TABLET, FILM COATED ORAL 20110225 NDA NDA021085 RedPharm Drug Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 67296-0220_e8c2f6fc-ccc4-47c8-9091-0a9ee553ef22 67296-0220 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20071101 ANDA ANDA065291 RedPharm Drug Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67296-0271_15a13d7b-63f9-4c78-9ca8-2416bf41d70a 67296-0271 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 RedPharm Drug Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 67296-0306_8aac15c2-c997-4aae-a382-b1c424e930f8 67296-0306 HUMAN PRESCRIPTION DRUG LORAZEPAM lorazepam TABLET ORAL 19911031 ANDA ANDA072927 RedPharm Drug Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67296-0315_93149232-fbfa-443b-ae5b-b7302ebe5442 67296-0315 HUMAN PRESCRIPTION DRUG clindamycin hydrochloride clindamycin hydrochloride CAPSULE ORAL 20061101 ANDA ANDA065442 RedPharm Drug Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 67296-0320_76d06a53-0446-440a-9786-8ced37e43f04 67296-0320 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051201 ANDA ANDA065229 RedPharm Drug Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 67296-0362_96235673-b0d8-40aa-9115-c181a416af00 67296-0362 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 20100422 ANDA ANDA040409 RedPharm Drug Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67296-0369_1cc23bf2-170e-4170-9299-bfaa55d06ec7 67296-0369 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen TABLET ORAL 20110118 ANDA ANDA073517 RedPharm Drug Inc. KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67296-0372_9ee3191e-6836-4324-892c-1ccd55baf473 67296-0372 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 RedPharm Drug Inc. LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 67296-0375_75712ad2-36fe-4a9d-a722-970e4e594bec 67296-0375 HUMAN PRESCRIPTION DRUG ACYCLOVIR acyclovir TABLET ORAL 20090401 ANDA ANDA074596 RedPharm Drug Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 67296-0377_23e2cf2e-a51b-4c3a-82b9-b3aaf3d52290 67296-0377 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040769 RedPharm Drug Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67296-0378_9ba73fe0-6055-41e1-9a04-7c07e5e8f20c 67296-0378 HUMAN PRESCRIPTION DRUG Propoxyphene Napsylate and Acetaminophen Propoxyphene Napsylate and Acetaminophen TABLET, FILM COATED ORAL 20091125 ANDA ANDA074119 RedPharm Drug Inc. ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 650; 100 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 67296-0381_1cb85a09-685d-498e-89e1-d4cf7666ab19 67296-0381 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20090807 ANDA ANDA088349 RedPharm Drug Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 67296-0431_c9495efd-8822-45ae-ac8c-2ede51b63b23 67296-0431 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080201 ANDA ANDA074112 RedPharm Drug Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67296-0447_dcde7446-4610-452d-ac4b-9eb57f78c252 67296-0447 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100218 ANDA ANDA078218 RedPharm Drug Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 67296-0466_3409547b-5675-4e7d-8498-27b3138012b7 67296-0466 HUMAN PRESCRIPTION DRUG Hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20100118 ANDA ANDA040729 RedPharm Drug Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67296-0469_8c09ec2d-1a14-4b90-9d22-beeeb7a40a5c 67296-0469 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20070501 ANDA ANDA065264 RedPharm Drug Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 67296-0470_6ba7a36b-e85b-44e0-b066-967c9a5a81fe 67296-0470 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 19981202 ANDA ANDA089971 RedPharm Drug Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67296-0492_0537f016-22d4-4f35-9a27-b41399c619c0 67296-0492 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Tablets Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040748 RedPharm Drug Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67296-0499_fcf959cd-925b-4eb1-8a7a-b5e25e64cad0 67296-0499 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040746 RedPharm Drug Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67296-0505_f44273ab-8fd1-4b8f-92a8-b57e5d6f0baa 67296-0505 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 RedPharm Drug, Inc. ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 67296-0506_0f905f40-eed8-47a7-bd55-0fdacc5fcc55 67296-0506 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060501 ANDA ANDA071135 RedPharm Drug Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67296-0515_300e099d-aa1b-460a-8b1d-44765cfdbbac 67296-0515 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 RedPharm Drug Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67296-0522_09105b89-85a1-40da-a83b-5d3c887f1746 67296-0522 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040777 RedPharm Drug Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 67296-0527_94abb33a-586c-4d91-8253-79e050a023d1 67296-0527 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20100716 ANDA ANDA070719 RedPharm Drug Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67296-0528_0c040e84-c16a-4fea-b2bb-dc83ae0887a5 67296-0528 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin (monohydrate/macrocrystals) CAPSULE ORAL 19701125 ANDA ANDA080043 RedPharm Drug Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 67296-0529_ac20e366-ef84-4159-bddc-a4b10ff33f3a 67296-0529 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080601 ANDA ANDA074112 RedPharm ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67296-0537_89666922-fdfa-4644-a2e9-678c1836d74c 67296-0537 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070504 ANDA ANDA078413 RedPharm Drug, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 67296-0538_5b1d2ccf-10ff-43ba-9f4e-5d0722a91f1f 67296-0538 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 RedPharm Drug Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67296-0542_0e9d8cc1-dd98-48a8-ac5c-01c3ed29670b 67296-0542 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020702 ANDA ANDA075944 RedPharm Drug Inc. LISINOPRIL 20 mg/1 67296-0543_6150bd37-2019-48fa-8dde-5b361f61cedc 67296-0543 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride tablet TABLET ORAL 20110404 ANDA ANDA076089 RedPharm Drug Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 67296-0544_980307ab-36fe-453a-b5e4-eaf528919dd1 67296-0544 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 RedPharm Drug Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII 67296-0556_d13edce7-4b1b-418d-9879-54d1436d9a99 67296-0556 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20020917 ANDA ANDA075907 RedPharm Drug Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 67296-0560_08ca2c4e-2f88-4628-98c6-642874a35c48 67296-0560 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20070401 ANDA ANDA018851 RedPharm Drug Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67296-0567_8b3f6f42-e692-4b93-9e10-1537261b6d08 67296-0567 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100113 ANDA ANDA040682 RedPharm Drug Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 67296-0574_3f875486-bfd5-423f-8c77-5852c5fa7ed0 67296-0574 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 RedPharm Drug Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67296-0579_98eb16dd-de60-471b-a2da-dc9334f7e409 67296-0579 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20090801 ANDA ANDA077859 RedPharm Drug Inc. CIPROFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 67296-0580_3392ce15-9b61-4777-8785-fa1d200ae385 67296-0580 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 RedPharm Drug Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 67296-0581_c69fc778-67bf-40cf-b91a-f5e1e98e5875 67296-0581 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 RedPharm Drug Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 67296-0584_8a27ef49-e58a-4860-8a49-b98d11f1bf7b 67296-0584 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 RedPharm Drug Inc. LEVOFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 67296-0586_f988da15-db11-448a-b10b-e06ed3dbb758 67296-0586 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 RedPharm Drug Inc. LEVOFLOXACIN 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 67296-0589_fae37249-5c97-450a-89d2-fb3639833b6b 67296-0589 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 RedPharm Drug Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67296-0590_f4127116-3810-414d-9acf-ddb8e16fffbc 67296-0590 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET ORAL 20051208 ANDA ANDA065276 RedPharm Drug Inc. CEFPROZIL 500 mg/1 67296-0595_1f185c52-0399-4844-8e3e-6b48c6c221b1 67296-0595 HUMAN PRESCRIPTION DRUG ETODOLAC etodolac TABLET, FILM COATED ORAL 20081201 ANDA ANDA074819 RedPharm Drug Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67296-0599_066c92b9-dd45-47a4-8eca-28a553e0fb96 67296-0599 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 RedPharm Drug Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 67296-0600_e59e1b07-a2b8-4d9b-9536-1734234d78dc 67296-0600 HUMAN PRESCRIPTION DRUG PREDNISONE prednisone TABLET ORAL 20030212 ANDA ANDA040392 RedPharm Drug Inc. PREDNISONE 20 mg/1 67296-0602_5c51a954-e9a5-46e0-96fd-ae310d246b0c 67296-0602 HUMAN PRESCRIPTION DRUG PREDNISONE prednisone TABLET ORAL 20020712 ANDA ANDA040256 RedPharm Drug Inc. PREDNISONE 10 mg/1 67296-0608_2b413941-3bde-4c99-8778-b08bd8feae88 67296-0608 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 RedPharm Drug Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 67296-0616_2af471ba-4ea3-48ee-85a2-d013e958abbe 67296-0616 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 RedPharm Drug Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67296-0618_aa400ebf-b711-4302-acae-5f6b8122f576 67296-0618 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 RedPharm Drug Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67296-0619_076feca1-d3a1-4733-8fbc-176063693b3a 67296-0619 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 RedPharm Drug Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 67296-0620_266375f9-0826-434d-99fe-bd6b47bb0a89 67296-0620 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 RedPharm Drug Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 67296-0622_280a6a29-4cb2-471a-a85b-6604a2b60118 67296-0622 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20051117 ANDA ANDA077321 RedPharm Drug Inc. LISINOPRIL 10 mg/1 67296-0627_33b58390-3857-4813-a4e4-a32601166209 67296-0627 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 RedPharm Drug Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67296-0628_a11bffa2-a62e-467f-819c-bbabe82bb568 67296-0628 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20060329 ANDA ANDA065255 RedPharm Drug Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 67296-0630_365c85fe-7466-4687-a6a1-0a36772a082f 67296-0630 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 RedPharm Drug Inc. LISINOPRIL 20 mg/1 67296-0642_fc24c4f6-e7fe-42a2-b994-3c5be77b31f5 67296-0642 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 19960412 ANDA ANDA040157 RedPharm Drug Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67296-0643_3632a93c-5fcc-423e-b268-fbdc4165676e 67296-0643 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 19960229 ANDA ANDA040144 RedPharm Drug Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67296-0648_733c7067-a5bc-402a-acba-69d784b6f2a2 67296-0648 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 RedPharm Drug Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 67296-0649_d0ef9b30-5af2-41e1-ab50-29c6562dca8f 67296-0649 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 20000531 ANDA ANDA040356 RedPharm Drug Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67296-0650_73b6c4d0-18f6-4a87-b0f4-14a502f6f98c 67296-0650 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 RedPharm Drug Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 67296-0651_096ab05e-19ed-4a20-b014-d9c0bab6fb19 67296-0651 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 19960426 ANDA ANDA040119 RedPharm Drug Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL CV 67296-0658_fda7b707-6391-403d-afd8-f825dc76777c 67296-0658 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20110110 ANDA ANDA073652 RedPharm Drug Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 67296-0671_1fbe2e01-e100-4324-91b8-06254f08f604 67296-0671 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 RedPharm Drug Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67296-0672_881854c7-5b09-4a6a-8b47-dd6018bceb40 67296-0672 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 19920731 NDA AUTHORIZED GENERIC NDA019787 RedPharm Drug Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 67296-0673_c993ef46-71d6-4118-9749-73f347cd10a7 67296-0673 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 19920731 NDA AUTHORIZED GENERIC NDA019787 RedPharm Drug Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 67296-0674_70cf4771-54a3-45ab-8020-45d0e9a0afad 67296-0674 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 RedPharm Drug Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67296-0676_f78df56b-0a2e-402a-be14-15350eaf5318 67296-0676 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 RedPharm Drug Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67296-0677_18070724-8a6b-4386-8c8e-4021869d3e21 67296-0677 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 RedPharm Drug Inc. CAPTOPRIL 15 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 67296-0678_0188b189-ceb0-492d-a252-f00de0f616a2 67296-0678 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 RedPharm Drug Inc. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 67296-0681_1ba40f55-ff0f-4b7d-b104-ce85f04cf9c2 67296-0681 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20070905 ANDA ANDA078251 RedPharm Drug Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 67296-0683_c20e9153-7427-44bd-9806-bc1a5fd1e439 67296-0683 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 RedPharm Drug Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67296-0716_8253cee0-e372-4f2c-9f90-2b26d31123d6 67296-0716 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20080201 ANDA ANDA065109 RedPharm Drug Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 67296-0718_b52013af-ca95-4ef1-bcfd-15d49dd04df7 67296-0718 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 20030827 ANDA ANDA040511 RedPharm Drug Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 67296-0719_0253ef3f-b35b-4f42-ab27-75b3e66ca2a7 67296-0719 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN ydrocodone bitartrate and acetaminophen TABLET ORAL 19960222 ANDA ANDA040143 RedPharm Drug Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67296-0726_4a401ce3-1d88-427f-a854-9e7283ec0aaa 67296-0726 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20100518 ANDA ANDA077657 RedPharm Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67296-0755_962c51e5-5728-4c10-b3ed-d58aad030262 67296-0755 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 RedPharm Drug Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67296-0759_2ac71f36-5d44-41fd-b850-d3c20d968623 67296-0759 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET ORAL 20081121 ANDA ANDA078616 RedPharm Drug Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] 67296-0801_d5691a6a-4f57-4ddc-8ee7-0d2b56cf43ed 67296-0801 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE Acetazolamide TABLET ORAL 19780331 ANDA ANDA084840 RedPharm Drug Inc. ACETAZOLAMIDE 250 1/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 67296-0803_8fa98bad-bdd8-444f-abc6-0b864ea000c0 67296-0803 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 RedPharm Drug Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 67296-0804_a6765670-7036-4d4b-9349-94969b6841d4 67296-0804 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 RedPharm Drug Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67296-0822_ad7a1d63-e799-43b4-9c23-f426151ade6e 67296-0822 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 RedPharm Drug Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 67303-501_a0965ef4-74e4-49ae-b4f3-0d49f78b5b3d 67303-501 HUMAN OTC DRUG SmileActives Pro Whitening Fluoride PASTE, DENTIFRICE DENTAL 20140128 OTC MONOGRAPH NOT FINAL part356 Oraceutical SODIUM FLUORIDE .24 g/100g 67308-101_05d770b7-bd7e-ad2f-4ad4-2ac2f59967bb 67308-101 HUMAN PRESCRIPTION DRUG LEVULAN KERASTICK aminolevulinic acid hydrochloride KIT 20000904 NDA NDA020965 DUSA Pharmaceuticals, Inc. 67318-001_409e00d3-2fa6-49fa-a72f-8b9725cdb1ce 67318-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Tru-Care Medical, Inc. OXYGEN 99 L/100L 67326-350_f8875943-2004-4b86-9b1c-e1dcb9dfd67c 67326-350 HUMAN OTC DRUG Prep Solution Topical Antiseptic Microbicide Povidone-Iodine SOLUTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333 Degasa SA de CV POVIDONE-IODINE .1 mL/mL 67326-351_85bab255-1ff5-4324-b9aa-f753bb94e4ea 67326-351 HUMAN OTC DRUG Surgical Scrub Skin Cleanser Povidone-Iodine SOLUTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333 Degasa SA De CV POVIDONE-IODINE .075 mL/mL 67334-0457_9545cf71-0ba2-4098-87ff-31b10f143f5a 67334-0457 STANDARDIZED ALLERGENIC T.R.U.E. Test Thin-Layer Rapid Use Patch Test Standardized Allergenic KIT 20120301 BLA BLA103738 SmartPractice Denmark ApS 67345-0001_03ffb5a5-ba6b-4c4c-8e76-9fa6db458b77 67345-0001 HUMAN OTC DRUG Purminerals 4-in-1 Mineral Tinted Moisturizer Broad Spectrum SPF 20 (LIGHT) Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 Purminerals TITANIUM DIOXIDE; ZINC OXIDE 5; 5 g/100g; g/100g 67345-0002_03ffb5a5-ba6b-4c4c-8e76-9fa6db458b77 67345-0002 HUMAN OTC DRUG Purminerals 4-in-1 Mineral Tinted Moisturizer Broad Spectrum SPF 20 (MEDIUM) Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 Purminerals TITANIUM DIOXIDE; ZINC OXIDE 5; 5 g/100g; g/100g 67345-0003_03ffb5a5-ba6b-4c4c-8e76-9fa6db458b77 67345-0003 HUMAN OTC DRUG Purminerals 4-in-1 Mineral Tinted Moisturizer Broad Spectrum SPF 20 (TAN) Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 Purminerals TITANIUM DIOXIDE; ZINC OXIDE 5; 5 g/100g; g/100g 67345-0004_03ffb5a5-ba6b-4c4c-8e76-9fa6db458b77 67345-0004 HUMAN OTC DRUG Purminerals 4-in-1 Mineral Tinted Moisturizer Broad Spectrum SPF 20 (DARK) Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 Purminerals TITANIUM DIOXIDE; ZINC OXIDE 5; 5 g/100g; g/100g 67345-0005_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0005 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (LIGHT) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL 67345-0006_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0006 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (BLUSH MEDIUM) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL 67345-0007_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0007 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (GOLDEN MEDIUM) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL 67345-0008_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0008 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (LIGHT TAN) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL 67345-0009_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0009 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (TAN) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL 67345-0010_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0010 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (MEDIUM DARK) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL 67345-0011_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0011 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (GOLDEN DARK) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL 67345-0012_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0012 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (DEEP) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL 67345-0013_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0013 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (DEEPER) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL 67345-0509_529bac52-8605-4e20-8490-3c4577f63dd7 67345-0509 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Porcelain Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g 67345-0510_8e5953f8-367c-4ab8-aae8-3743338fbae4 67345-0510 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Light Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PURMINERALS TITANIUM DIOXIDE .387 g/4.3g 67345-0511_a7a9f744-970e-401f-8958-01bf3ba10646 67345-0511 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Blush Medium Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g 67345-0512_34a22d13-f32d-41ee-a0e4-e0b71edda171 67345-0512 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Golden Medium Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .38 g/4.25g 67345-0513_f783a5e5-4f99-4751-beb2-65e20697721d 67345-0513 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Tan Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PURMINERALS TITANIUM DIOXIDE .387 g/4.3g 67345-0514_d79bb970-c0bd-41af-a970-7ce0859f419f 67345-0514 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Dark Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g 67345-0515_5cf3e82b-747a-4ea0-9b1e-9d44730f5f16 67345-0515 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Medium Dark Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g 67345-0516_1308d29d-34a4-4079-921c-0a69191c23e2 67345-0516 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Deep Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .38 g/4.25g 67345-0517_56457907-730d-4885-bda3-a5ed85e99b46 67345-0517 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Deepest Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .38 g/4.25g 67345-0518_3fec5ed5-6fea-43a8-9965-8cb9fe7febd5 67345-0518 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Deeper Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .38 g/4.25g 67345-0611_e3a50694-fa40-4dc9-be4c-1bcf5b943834 67345-0611 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Light Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0631_f4dc348c-041f-4358-8a1a-fe1b53edc440 67345-0631 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Tan Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0641_6c661a83-e337-44c1-b268-8cf03677a37d 67345-0641 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Dark Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0661_1037daf6-796d-4f6f-8488-9644dbd38c17 67345-0661 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Golden Medium Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0671_03609d73-958d-42ce-a2b2-d1baaea34527 67345-0671 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Medium Dark Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0681_98de3bfe-f380-478f-b5b4-e2135413b872 67345-0681 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Deep Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0691_d7716db1-b586-47a1-8825-de06b06a4fef 67345-0691 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Deeper Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0701_f554472c-b478-4232-8a64-cc516f01bd60 67345-0701 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Deepest Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0702_6400d4c9-0f13-4250-9034-29cee8127fdb 67345-0702 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Porcelain Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0703_3b9b67c1-e612-4939-8de1-b3a94697aa7c 67345-0703 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Blush Medium Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PURMINERALS TITANIUM DIOXIDE .72 g/8g 67345-0780_fad4c10c-e44f-4d0b-afa3-cea163c96863 67345-0780 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Porcelain Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0781_e5d669fe-4f6d-4e3d-be9d-f8ae69e5aeea 67345-0781 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Light Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0782_5c7bc64d-ffc0-4473-aa4f-d63fbf253eec 67345-0782 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Blush Medium Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0783_e032225c-cfdd-4461-8f10-7933da6fdaf9 67345-0783 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Golden Medium Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0784_82372610-b63f-4d50-a6df-aed20e939036 67345-0784 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Light Tan Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0785_ef57a371-9fdc-4a1d-ac18-db0c426e7b7b 67345-0785 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Tan Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0786_75702240-c939-48c1-a17c-15f7a1f9310b 67345-0786 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Medium Dark Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0787_a5bb2e2e-3d96-46ff-a6cc-d94a7950c9eb 67345-0787 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Golden Dark Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0788_c34d07c4-6993-42a3-85be-34576165d619 67345-0788 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Deep Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-0789_27552de9-6555-414b-9daf-2cc1c3665efb 67345-0789 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Deeper Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g 67345-6080_9d94185f-b71b-401a-9204-59efbe1200ba 67345-6080 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Golden Dark Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g 67345-6082_7295fb80-1926-446f-9ea2-96c5bf91987d 67345-6082 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Porcelain Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g 67345-6083_817215de-707e-4e7e-8f27-57be15a2d87c 67345-6083 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Light Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g 67345-6084_040d9923-42ad-415e-807d-3c0bf3ed950e 67345-6084 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Blush Medium Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g 67345-6085_768678a7-0132-4308-9a6d-545ff982c3c3 67345-6085 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Medium Dark Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g 67345-6086_10863efd-d894-4350-9507-bf95f3756caa 67345-6086 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Golden Medium Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g 67345-6087_45370c67-e4d7-4e68-96fc-cedc79aee6a8 67345-6087 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Light Tan Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g 67345-6088_f034a4b4-b551-4929-ba15-78e7195365d9 67345-6088 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Tan Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g 67361-001_6deb627a-b6bf-42b2-8b1e-7d5996313315 67361-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020801 UNAPPROVED MEDICAL GAS American Home Health Care, Inc. OXYGEN 210 mL/L 67365-001_db0ede99-c87b-4148-a67e-34fdf24c4c90 67365-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130313 UNAPPROVED MEDICAL GAS Camelot Healthcare Management Inc. dba Suncare Respiratory Services OXYGEN 99 L/100L 67378-001_a3db2964-5284-4598-8a8f-fb8c25f57d6d 67378-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS B-Pharm, Inc dba Remedies Medical Equipment OXYGEN 99 L/100L 67386-111_45d728d5-3552-458f-aa0a-9f4f68f269cc 67386-111 HUMAN PRESCRIPTION DRUG SABRIL vigabatrin TABLET, FILM COATED ORAL 20090821 NDA NDA020427 Lundbeck LLC VIGABATRIN 500 mg/1 Anti-epileptic Agent [EPC] 67386-211_f00630d9-11fe-46d7-b0cf-1d6bfda9d0b4 67386-211 HUMAN PRESCRIPTION DRUG SABRIL vigabatrin POWDER, FOR SOLUTION ORAL 20090821 NDA NDA022006 Lundbeck LLC VIGABATRIN 50 mg/mL Anti-epileptic Agent [EPC] 67386-310_ef6adad4-4b43-4d8e-a9dc-d3cc985e38c9 67386-310 HUMAN PRESCRIPTION DRUG Onfi clobazam TABLET ORAL 20111021 20160228 NDA NDA202067 Lundbeck LLC CLOBAZAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Cytochrome P450 2D6 Inhibitors [MoA] CIV 67386-311_ef6adad4-4b43-4d8e-a9dc-d3cc985e38c9 67386-311 HUMAN PRESCRIPTION DRUG Onfi clobazam TABLET ORAL 20130812 20160430 NDA NDA202067 Lundbeck LLC CLOBAZAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Cytochrome P450 2D6 Inhibitors [MoA] CIV 67386-312_ef6adad4-4b43-4d8e-a9dc-d3cc985e38c9 67386-312 HUMAN PRESCRIPTION DRUG Onfi clobazam TABLET ORAL 20130812 20160630 NDA NDA202067 Lundbeck LLC CLOBAZAM 20 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Cytochrome P450 2D6 Inhibitors [MoA] CIV 67386-313_ef6adad4-4b43-4d8e-a9dc-d3cc985e38c9 67386-313 HUMAN PRESCRIPTION DRUG Onfi clobazam SUSPENSION ORAL 20121214 NDA NDA203993 Lundbeck LLC CLOBAZAM 2.5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Cytochrome P450 2D6 Inhibitors [MoA] CIV 67386-314_ef6adad4-4b43-4d8e-a9dc-d3cc985e38c9 67386-314 HUMAN PRESCRIPTION DRUG Onfi clobazam TABLET ORAL 20131210 NDA NDA202067 Lundbeck LLC CLOBAZAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Cytochrome P450 2D6 Inhibitors [MoA] CIV 67386-315_ef6adad4-4b43-4d8e-a9dc-d3cc985e38c9 67386-315 HUMAN PRESCRIPTION DRUG Onfi clobazam TABLET ORAL 20131210 NDA NDA202067 Lundbeck LLC CLOBAZAM 20 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Cytochrome P450 2D6 Inhibitors [MoA] CIV 67386-421_269a1a41-c2d1-435f-92e5-1b69a2e99389 67386-421 HUMAN PRESCRIPTION DRUG Xenazine tetrabenazine TABLET ORAL 20081124 NDA NDA021894 Lundbeck Inc. TETRABENAZINE 12.5 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] 67386-422_269a1a41-c2d1-435f-92e5-1b69a2e99389 67386-422 HUMAN PRESCRIPTION DRUG Xenazine tetrabenazine TABLET ORAL 20081124 NDA NDA021894 Lundbeck Inc. TETRABENAZINE 25 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] 67386-820_32c0f213-4479-4a01-b6fe-e58a104735c7 67386-820 HUMAN PRESCRIPTION DRUG Northera droxidopa CAPSULE ORAL 20140901 NDA NDA203202 Lundbeck LLC DROXIDOPA 100 mg/1 Catecholamines [Chemical/Ingredient],Increased Blood Pressure [PE] 67386-821_32c0f213-4479-4a01-b6fe-e58a104735c7 67386-821 HUMAN PRESCRIPTION DRUG Northera droxidopa CAPSULE ORAL 20140901 NDA NDA203202 Lundbeck LLC DROXIDOPA 200 mg/1 Catecholamines [Chemical/Ingredient],Increased Blood Pressure [PE] 67386-822_32c0f213-4479-4a01-b6fe-e58a104735c7 67386-822 HUMAN PRESCRIPTION DRUG Northera droxidopa CAPSULE ORAL 20140901 NDA NDA203202 Lundbeck LLC DROXIDOPA 300 mg/1 Catecholamines [Chemical/Ingredient],Increased Blood Pressure [PE] 67402-021_827f05fc-94d5-4bde-8c2f-e97d250d9660 67402-021 HUMAN PRESCRIPTION DRUG NeoBenz Micro Plus Pack benzoyl peroxide KIT 20090416 UNAPPROVED DRUG OTHER SkinMedica Pharmaceuticals, Inc. 67405-100_30911e24-bba3-b7f8-dd0f-e9e5a2af1aea 67405-100 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20060823 ANDA ANDA077447 Harris Pharmaceutical, Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 67405-110_a04c0094-b66a-6690-5c2f-299b10cf3131 67405-110 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole CREAM TOPICAL 20080313 ANDA ANDA077549 Harris Pharmaceutical, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 67405-275_e1c9385c-0117-c179-37c4-6a8bb1b4ce80 67405-275 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate SOLUTION TOPICAL 20140304 ANDA ANDA077678 Harris Pharmaceutical, Inc. MOMETASONE FUROATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 67405-300_84e2046f-b47c-a7de-8505-39e1a9d3388a 67405-300 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20061018 ANDA ANDA077401 Harris Pharmaceutical, Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 67405-435_510bb42a-bb41-46e3-a98c-dd8ea86282ba 67405-435 HUMAN PRESCRIPTION DRUG Topical Cleanser Benzoyl Peroxide SOAP TOPICAL 20101118 UNAPPROVED DRUG OTHER Harris Pharmaceutical, Inc. BENZOYL PEROXIDE 60 mg/g 67405-450_de4400f7-a371-ee85-e41b-e76724c90be0 67405-450 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SOLUTION TOPICAL 20070919 ANDA ANDA078233 Harris Pharmaceutical, Inc. CICLOPIROX 80 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 67405-500_51498134-4f1d-4193-b1c3-e2b2471d98d2 67405-500 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20140813 ANDA ANDA077137 Harris Pharmaceutical, Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 67405-543_6154aa0a-55b4-478b-9edd-503a96ec0dac 67405-543 HUMAN PRESCRIPTION DRUG Terbinafine Terbinafine TABLET ORAL 20070730 ANDA ANDA077919 HARRIS Pharmaceutical, Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 67405-550_944e8f19-7b3d-491e-bb3e-fcfea33952f0 67405-550 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 Harris Pharmaceutical, Inc DOXYCYCLINE HYCLATE 100 mg/1 67405-575_1544ea6c-fc7e-4745-8d02-9f96198cab0f 67405-575 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20070629 ANDA ANDA040808 HARRIS Pharmaceutical, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 67405-577_1544ea6c-fc7e-4745-8d02-9f96198cab0f 67405-577 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20070629 ANDA ANDA040808 HARRIS Pharmaceutical, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 67405-650_5d135bd6-99e3-43b4-8e72-c297473b246d 67405-650 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Harris Pharmaceutical, Inc DOXYCYCLINE HYCLATE 50 mg/1 67405-651_5d135bd6-99e3-43b4-8e72-c297473b246d 67405-651 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Harris Pharmaceutical, Inc DOXYCYCLINE HYCLATE 100 mg/1 67405-671_1544ea6c-fc7e-4745-8d02-9f96198cab0f 67405-671 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20070629 ANDA ANDA040808 HARRIS Pharmaceutical, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 67405-825_b1583972-8ae0-457b-9ddf-f8e61135484e 67405-825 HUMAN OTC DRUG Benzoyl Peroxide Benzoyl Peroxide LIQUID TOPICAL 20111118 OTC MONOGRAPH FINAL part333D Harris Pharmaceutical, Inc. BENZOYL PEROXIDE 50 mg/mL 67405-830_3ee955d3-53e2-4a01-992c-084762e4bef6 67405-830 HUMAN OTC DRUG Benzoyl Peroxide Benzoyl Peroxide LIQUID TOPICAL 20111118 OTC MONOGRAPH FINAL part333D Harris Pharmaceutical, Inc. BENZOYL PEROXIDE 100 mg/mL 67405-835_ef512c34-7112-47d4-a67b-3fe2695817ef 67405-835 HUMAN OTC DRUG Benzoyl Peroxide Benzoyl Peroxide LIQUID TOPICAL 20111118 OTC MONOGRAPH FINAL part333D Harris Pharmaceutical, Inc. BENZOYL PEROXIDE 60 mg/mL 67425-002_ec2bd376-a904-8ef4-0daf-0b071de70e9c 67425-002 HUMAN PRESCRIPTION DRUG VITRASE hyaluronidase, ovine INJECTION, SOLUTION SUBCUTANEOUS 20050201 NDA NDA021640 ISTA Pharmaceuticals, Inc. HYALURONIDASE, OVINE 200 [USP'U]/mL Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient] 67425-003_49b5de8f-1a37-4d82-7d6d-ab8ab0d57e66 67425-003 HUMAN PRESCRIPTION DRUG Istalol timolol maleate SOLUTION OPHTHALMIC 20040801 NDA NDA021516 ISTA PHARMACEUTICALS, INC. TIMOLOL MALEATE 5 mg/mL 67425-999_91c8f7cb-a7cc-ae34-87ff-fa94aafe6cea 67425-999 HUMAN PRESCRIPTION DRUG Bromday bromfenac SOLUTION/ DROPS OPHTHALMIC 20100920 NDA NDA021664 Ista Pharmaceuticals, Inc BROMFENAC SODIUM .9 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67441-0001_5de233fa-49c1-48e6-b2f6-2f702c80913b 67441-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030301 UNAPPROVED MEDICAL GAS Plaza Home Care, Inc. OXYGEN 99 L/100L 67457-001_5371c3c1-9f61-4554-a463-b9eda227761f 67457-001 HUMAN PRESCRIPTION DRUG Ketamine Hydrochloride Ketamine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130604 ANDA ANDA076092 Mylan Institutional LLC KETAMINE HYDROCHLORIDE 50 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII 67457-108_5371c3c1-9f61-4554-a463-b9eda227761f 67457-108 HUMAN PRESCRIPTION DRUG Ketamine Hydrochloride Ketamine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130604 ANDA ANDA076092 Mylan Institutional LLC KETAMINE HYDROCHLORIDE 100 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII 67457-118_f67ce1df-27ea-4c67-a8a3-daf3fb3b9a92 67457-118 HUMAN PRESCRIPTION DRUG Ascorbic Acid Ascorbic Acid INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19990601 UNAPPROVED DRUG OTHER Mylan Institutional LLC ASCORBIC ACID 500 mg/mL 67457-124_4d59f9ec-c2d5-41b2-b9f2-d056db9417dd 67457-124 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130509 ANDA ANDA040498 Mylan Institutional LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 67457-134_5d074715-0142-4e7f-af09-2956d21c675e 67457-134 HUMAN PRESCRIPTION DRUG Magnesium Chloride magnesium chloride INJECTION INTRAVENOUS 20130314 UNAPPROVED DRUG OTHER Mylan Institutional LLC MAGNESIUM CHLORIDE 200 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 67457-146_9160e788-7e5f-41ef-89f6-0350c132fa39 67457-146 HUMAN PRESCRIPTION DRUG Vitamin B Complex thiamine hydrochloride, riboflavin 5 phosphate sodium, dexpanthenol and niacinamide INJECTION INTRAVENOUS 20130510 UNAPPROVED DRUG OTHER Mylan Institutional LLC DEXPANTHENOL; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE 2; 100; 2; 2; 100 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 67457-148_e00ff589-c7b3-4f35-ae68-05aa484482da 67457-148 HUMAN PRESCRIPTION DRUG Mesna mesna INJECTION, SOLUTION INTRAVENOUS 20120403 ANDA ANDA076488 Mylan Institutional LLC MESNA 100 mg/mL Cytoprotective Agent [EPC] 67457-153_97588271-5cf3-4101-8b1c-3b2a9b70cdfe 67457-153 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride amiodarone hydrochloride INJECTION, SOLUTION INTRAVENOUS 20021014 ANDA ANDA076217 Mylan Institutional LLC AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 67457-162_299c3a3f-da6e-439d-872f-15f761c152d8 67457-162 HUMAN PRESCRIPTION DRUG Sotradecol tetradecyl hydrogen sulfate (ester) INJECTION, SOLUTION INTRAVENOUS 20130429 ANDA ANDA040541 Mylan Institutional LLC TETRADECYL HYDROGEN SULFATE (ESTER) 10 mg/mL 67457-163_299c3a3f-da6e-439d-872f-15f761c152d8 67457-163 HUMAN PRESCRIPTION DRUG Sotradecol tetradecyl hydrogen sulfate (ester) INJECTION, SOLUTION INTRAVENOUS 20130429 ANDA ANDA040541 Mylan Institutional LLC TETRADECYL HYDROGEN SULFATE (ESTER) 30 mg/mL 67457-176_79325341-258f-4ad1-b554-8b51512f0e9f 67457-176 HUMAN PRESCRIPTION DRUG Sotalol hydrochloride Sotalol hydrochloride INJECTION INTRAVENOUS 20090930 NDA NDA022306 Mylan Institutional LLC SOTALOL HYDROCHLORIDE 15 mg/mL Antiarrhythmic [EPC] 67457-177_3cda0c5c-23fc-4f9a-bfbc-3f39ac09de9c 67457-177 HUMAN PRESCRIPTION DRUG RIMSO-50 Dimethyl Sulfoxide IRRIGANT INTRAVESICAL 19780404 NDA NDA017788 Mylan Institutional LLC DIMETHYL SULFOXIDE .54 g/mL 67457-181_5371c3c1-9f61-4554-a463-b9eda227761f 67457-181 HUMAN PRESCRIPTION DRUG Ketamine Hydrochloride Ketamine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130604 ANDA ANDA076092 Mylan Institutional LLC KETAMINE HYDROCHLORIDE 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII 67457-182_aaa7c217-e7e3-4e8e-88ea-6ec5c1a8d1b9 67457-182 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride esmolol hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130221 ANDA ANDA076474 Mylan Institutional LLC ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67457-183_1bf58b60-2972-4900-b2cd-300fb79edf7c 67457-183 HUMAN PRESCRIPTION DRUG Etomidate etomidate INJECTION, SOLUTION INTRAVENOUS 20130426 ANDA ANDA091297 Mylan Institutional LLC ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 67457-187_2459a429-7031-454e-a6ef-144bb4cd1870 67457-187 HUMAN PRESCRIPTION DRUG Aloprim Allopurinol INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19960501 NDA NDA020298 Mylan Institutional LLC ALLOPURINOL 500 mg/25mL Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 67457-189_890c93dd-26ea-4f3b-9a45-e37fba0ecc1f 67457-189 HUMAN PRESCRIPTION DRUG MEFOXIN cefoxitin sodium INJECTION, SOLUTION INTRAVENOUS 20110222 ANDA ANDA063182 Bioniche Pharma USA LLC CEFOXITIN SODIUM 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 67457-190_91687c49-8f28-499e-9999-9b51154ad379 67457-190 HUMAN PRESCRIPTION DRUG Enlon edrophonium chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130422 ANDA ANDA088873 Mylan Institutional LLC EDROPHONIUM CHLORIDE 10 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 67457-192_91173b67-b234-4b01-8598-5e14b8ef2fe4 67457-192 HUMAN PRESCRIPTION DRUG Enlon Plus Edrophonium Chloride and Atropine Sulfate INJECTION, SOLUTION INTRAVENOUS 19911106 NDA NDA019678 Mylan Institutional LLC ATROPINE SULFATE; EDROPHONIUM CHLORIDE .14; 10 mg/mL; mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 67457-195_5d8d726f-5a26-4de9-b663-5753013604d4 67457-195 HUMAN PRESCRIPTION DRUG Melphalan Hydrochloride Melphalan Hydrochloride KIT 20130110 ANDA ANDA090270 Mylan Institutional LLC 67457-196_6f1105a8-624b-4a74-a14f-8738ef4d7193 67457-196 HUMAN PRESCRIPTION DRUG Thiamine Hydrochloride thiamine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130604 ANDA ANDA091623 Mylan Institutional LLC THIAMINE HYDROCHLORIDE 100 mg/mL 67457-197_9d2a06da-dea1-439e-97a3-41067cb102ef 67457-197 HUMAN PRESCRIPTION DRUG Tranexamic Acid tranexamic acid INJECTION, SOLUTION INTRAVENOUS 20111129 ANDA ANDA091657 Mylan Institutional LLC TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 67457-198_93ecfc3d-7910-43eb-bd90-5fe8c7ba4696 67457-198 HUMAN PRESCRIPTION DRUG Ultiva Remifentanil Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19960712 NDA NDA020630 Mylan Institutional LLC REMIFENTANIL HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 67457-207_f9a492db-f9dc-4065-b11b-2e14bd2162a3 67457-207 HUMAN PRESCRIPTION DRUG Dexrazoxane Hydrochloride dexrazoxane KIT 20111118 ANDA ANDA200752 Mylan Institutional LLC 67457-208_f9a492db-f9dc-4065-b11b-2e14bd2162a3 67457-208 HUMAN PRESCRIPTION DRUG Dexrazoxane Hydrochloride dexrazoxane KIT 20111118 ANDA ANDA200752 Mylan Institutional LLC 67457-210_cdf09920-bfe5-407c-921f-f4aefca3e29e 67457-210 HUMAN PRESCRIPTION DRUG Cidofovir Cidofovir Anhydrous INJECTION, SOLUTION INTRAVENOUS 20130603 ANDA ANDA201276 Mylan Institutional LLC CIDOFOVIR 75 mg/mL Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient] 67457-211_0962bbdd-0d84-4e9a-b330-7d645599bcb0 67457-211 HUMAN PRESCRIPTION DRUG Fomepizole Fomepizole INJECTION, SOLUTION INTRAVENOUS 20121009 ANDA ANDA078639 Mylan Institutional LLC FOMEPIZOLE 1 g/mL Antidote [EPC] CIII 67457-215_5d8d726f-5a26-4de9-b663-5753013604d4 67457-215 HUMAN PRESCRIPTION DRUG Melphalan Hydrochloride Melphalan Hydrochloride KIT 20130110 ANDA ANDA090270 Mylan Institutional LLC 67457-216_890c93dd-26ea-4f3b-9a45-e37fba0ecc1f 67457-216 HUMAN PRESCRIPTION DRUG MEFOXIN cefoxitin sodium INJECTION, SOLUTION INTRAVENOUS 20110222 ANDA ANDA063182 Bioniche Pharma USA LLC CEFOXITIN SODIUM 2 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 67457-217_7cd01164-a9a8-42c5-9f5f-12e933cc78cb 67457-217 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19470813 NDA NDA021624 Mylan Institutional LLC METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 67457-218_e3b05939-069f-4822-8694-b693a044adb3 67457-218 HUMAN PRESCRIPTION DRUG Duraclon clonidine hydrochloride INJECTION, SOLUTION EPIDURAL 19961002 NDA NDA020615 Mylan Institutional LLC CLONIDINE HYDROCHLORIDE .1 mg/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 67457-219_e3b05939-069f-4822-8694-b693a044adb3 67457-219 HUMAN PRESCRIPTION DRUG Duraclon clonidine hydrochloride INJECTION, SOLUTION EPIDURAL 19961002 NDA NDA020615 Mylan Institutional LLC CLONIDINE HYDROCHLORIDE .5 mg/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 67457-220_edbeada8-1521-4961-8fc1-fd9794cfa35b 67457-220 HUMAN PRESCRIPTION DRUG Isosulfan Blue Isosulfan Blue INJECTION, SOLUTION SUBCUTANEOUS 20130314 ANDA ANDA090874 Mylan Institutional LLC ISOSULFAN BLUE 10 mg/mL 67457-221_314a6af2-e75d-4dfe-a944-8298d03db6c2 67457-221 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120627 ANDA ANDA040716 Mylan Institutional LLC METHOTREXATE 1 g/40mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 67457-222_7214b684-0407-4d5b-ad56-1a97fdd4cc93 67457-222 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080630 ANDA ANDA065401 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 67457-224_ce2304e0-b9fd-4612-96b0-ef611a71cd4e 67457-224 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride nicardipine hydrochloride INJECTION, SOLUTION INTRAVENOUS 20111223 ANDA ANDA090664 Mylan Institutional LLC NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 67457-225_7214b684-0407-4d5b-ad56-1a97fdd4cc93 67457-225 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120110 ANDA ANDA065401 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 67457-226_dac011a9-684b-4bda-b48b-3fb24a438dff 67457-226 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam ampicillin and sulbactam INJECTION, POWDER, FOR SUSPENSION INTRAMUSCULAR; INTRAVENOUS 20121127 ANDA ANDA065316 Mylan Institutional LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 250; 125 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 67457-227_f2f081d1-7608-417b-ba54-957a03e8cb85 67457-227 HUMAN PRESCRIPTION DRUG Cosyntropin cosyntropin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130508 ANDA ANDA090574 Mylan Institutional LLC COSYNTROPIN .25 mg/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] 67457-228_26fd96eb-9128-4ae1-bc61-2cf0f2a060b8 67457-228 HUMAN PRESCRIPTION DRUG Rocuronium Bromide rocuronium bromide INJECTION INTRAVENOUS 20130424 ANDA ANDA079199 Mylan Institutional LLC ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 67457-230_dac011a9-684b-4bda-b48b-3fb24a438dff 67457-230 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam ampicillin and sulbactam INJECTION, POWDER, FOR SUSPENSION INTRAMUSCULAR; INTRAVENOUS 20121127 ANDA ANDA065316 Mylan Institutional LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 250; 125 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 67457-238_bb24d345-8c08-4b1d-8a35-19ab05c0c1fc 67457-238 HUMAN PRESCRIPTION DRUG Fludarabine Phosphate Fludarabine Phosphate INJECTION, SOLUTION INTRAVENOUS 20130130 ANDA ANDA090724 Mylan Institutional LLC FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 67457-239_17dd21b1-fe77-4ef6-b06f-e0d57be58d71 67457-239 HUMAN PRESCRIPTION DRUG Octreotide Acetate octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20130425 ANDA ANDA079198 Mylan Institutional LLC OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 67457-245_17dd21b1-fe77-4ef6-b06f-e0d57be58d71 67457-245 HUMAN PRESCRIPTION DRUG Octreotide Acetate octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20130425 ANDA ANDA079198 Mylan Institutional LLC OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 67457-246_17dd21b1-fe77-4ef6-b06f-e0d57be58d71 67457-246 HUMAN PRESCRIPTION DRUG Octreotide Acetate octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20130425 ANDA ANDA079198 Mylan Institutional LLC OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] 67457-251_ebdfe2e8-30ca-4f18-935a-41bcbbce4937 67457-251 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride dexmedetomidine hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140818 ANDA ANDA202881 Mylan Institutional LLC DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] 67457-255_82f9fa22-9853-4865-99b2-b675cca2fc96 67457-255 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION INTRAVENOUS 20111110 NDA NDA202543 Mylan Institutional LLC LEVETIRACETAM 5 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67457-257_f2f081d1-7608-417b-ba54-957a03e8cb85 67457-257 HUMAN PRESCRIPTION DRUG Cosyntropin cosyntropin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130508 ANDA ANDA090574 Mylan Institutional LLC COSYNTROPIN .25 mg/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] 67457-259_edbeada8-1521-4961-8fc1-fd9794cfa35b 67457-259 HUMAN PRESCRIPTION DRUG Isosulfan Blue Isosulfan Blue INJECTION, SOLUTION SUBCUTANEOUS 20130314 ANDA ANDA090874 Mylan Institutional LLC ISOSULFAN BLUE 10 mg/mL 67457-263_db000162-0c09-45ad-974e-73d4b4541429 67457-263 HUMAN PRESCRIPTION DRUG chlorothiazide sodium chlorothiazide sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140808 ANDA ANDA202493 Mylan Institutional LLC CHLOROTHIAZIDE SODIUM 500 mg/18mL Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 67457-265_82f9fa22-9853-4865-99b2-b675cca2fc96 67457-265 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION INTRAVENOUS 20111110 NDA NDA202543 Mylan Institutional LLC LEVETIRACETAM 10 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67457-266_82f9fa22-9853-4865-99b2-b675cca2fc96 67457-266 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION INTRAVENOUS 20111110 NDA NDA202543 Mylan Institutional LLC LEVETIRACETAM 15 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67457-268_bb24d345-8c08-4b1d-8a35-19ab05c0c1fc 67457-268 HUMAN PRESCRIPTION DRUG Fludarabine Phosphate Fludarabine Phosphate INJECTION, SOLUTION INTRAVENOUS 20130130 ANDA ANDA090724 Mylan Institutional LLC FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 67457-273_78cdd6ef-0a76-411b-94a5-c1d8f5fc25d8 67457-273 HUMAN PRESCRIPTION DRUG METHOCARBAMOL methocarbamol INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20141205 ANDA ANDA204404 Mylan Institutional LLC METHOCARBAMOL 100 mg/mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 67457-280_b871d5af-6b2a-4939-a357-3e3779aac9f6 67457-280 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride labetalol INJECTION, SOLUTION INTRAVENOUS 20120629 ANDA ANDA090699 Mylan Institutional LLC LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67457-292_47a284bb-cf9c-4765-adb9-0ed84f3cb604 67457-292 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride naloxone hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20141217 ANDA ANDA204997 Mylan Institutional LLC NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 67457-293_9d2a06da-dea1-439e-97a3-41067cb102ef 67457-293 HUMAN PRESCRIPTION DRUG Tranexamic Acid tranexamic acid INJECTION, SOLUTION INTRAVENOUS 20111129 ANDA ANDA091657 Mylan Institutional LLC TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] 67457-303_f67ce1df-27ea-4c67-a8a3-daf3fb3b9a92 67457-303 HUMAN PRESCRIPTION DRUG Ascorbic Acid Ascorbic Acid INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19990601 UNAPPROVED DRUG OTHER Mylan Institutional LLC ASCORBIC ACID 500 mg/mL 67457-339_58613d32-2eea-4392-8744-cbe9945ac417 67457-339 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065397 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 67457-340_58613d32-2eea-4392-8744-cbe9945ac417 67457-340 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065397 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 67457-341_6cb412f8-6bd4-4d99-87ee-0af611e1336f 67457-341 HUMAN PRESCRIPTION DRUG vancomycin hydrochloride vancomycin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065432 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 5 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 67457-342_02015f06-356b-4898-ae98-ecefdd3bf480 67457-342 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110919 ANDA ANDA091554 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 10 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 67457-357_d75c17f4-b7f2-4218-8688-c7257ed377a4 67457-357 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride Epirubicin Hydrochloride INJECTION INTRAVENOUS 20130731 ANDA ANDA091599 Mylan Institutional LLC EPIRUBICIN HYDROCHLORIDE 50 mg/25mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 67457-358_d75c17f4-b7f2-4218-8688-c7257ed377a4 67457-358 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride Epirubicin Hydrochloride INJECTION INTRAVENOUS 20130731 ANDA ANDA091599 Mylan Institutional LLC EPIRUBICIN HYDROCHLORIDE 200 mg/100mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 67457-366_17751c36-e5ea-4d11-8103-3b3df46e6874 67457-366 HUMAN PRESCRIPTION DRUG Ibutilide Fumarate Ibutilide Fumarate INJECTION, SOLUTION INTRAVENOUS 20130108 ANDA ANDA090643 Mylan Institutional LLC IBUTILIDE FUMARATE .1 mg/mL Antiarrhythmic [EPC] 67457-381_5cb2c072-8782-4f5b-834f-6fe97991598c 67457-381 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20130423 ANDA ANDA075440 Mylan Institutional LLC HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] 67457-382_5cb2c072-8782-4f5b-834f-6fe97991598c 67457-382 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20130423 ANDA ANDA075440 Mylan Institutional LLC HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] 67457-390_0ddb0724-9733-442c-85ea-6620816b062d 67457-390 HUMAN PRESCRIPTION DRUG Zoledronic acid Zoledronic acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130305 ANDA ANDA202650 Mylan Institutional LLC ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 67457-393_73da585e-dd6c-4c51-852d-cd77783fcb9e 67457-393 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION INTRAVENOUS 20120214 ANDA ANDA200901 Mylan Institutional LLC DOXORUBICIN HYDROCHLORIDE 10 mg/5mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 67457-394_73da585e-dd6c-4c51-852d-cd77783fcb9e 67457-394 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION INTRAVENOUS 20120214 ANDA ANDA200901 Mylan Institutional LLC DOXORUBICIN HYDROCHLORIDE 20 mg/10mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 67457-395_73da585e-dd6c-4c51-852d-cd77783fcb9e 67457-395 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION INTRAVENOUS 20120214 ANDA ANDA200901 Mylan Institutional LLC DOXORUBICIN HYDROCHLORIDE 50 mg/25mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 67457-396_73da585e-dd6c-4c51-852d-cd77783fcb9e 67457-396 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION INTRAVENOUS 20120214 ANDA ANDA200901 Mylan Institutional LLC DOXORUBICIN HYDROCHLORIDE 200 mg/100mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 67457-409_5cb2c072-8782-4f5b-834f-6fe97991598c 67457-409 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20130423 ANDA ANDA075440 Mylan Institutional LLC HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] 67457-410_5cb2c072-8782-4f5b-834f-6fe97991598c 67457-410 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20130423 ANDA ANDA075440 Mylan Institutional LLC HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] 67457-418_572896a4-c8fe-49ef-be5f-1cde07766629 67457-418 HUMAN PRESCRIPTION DRUG Dexamethasone sodium phosphate Dexamethasone sodium phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Mylan Institutional LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 67457-419_572896a4-c8fe-49ef-be5f-1cde07766629 67457-419 HUMAN PRESCRIPTION DRUG Dexamethasone sodium phosphate Dexamethasone sodium phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Mylan Institutional LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 67457-420_d080dd60-fbaf-4f87-af5b-03a1e28b889d 67457-420 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110511 ANDA ANDA040802 Mylan Institutional LLC DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 67457-421_d080dd60-fbaf-4f87-af5b-03a1e28b889d 67457-421 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Mylan Institutional LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 67457-422_d080dd60-fbaf-4f87-af5b-03a1e28b889d 67457-422 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Mylan Institutional LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 67457-423_d080dd60-fbaf-4f87-af5b-03a1e28b889d 67457-423 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Mylan Institutional LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 67457-424_601e6d97-95d4-4ef8-9c70-1abdb57e3df3 67457-424 HUMAN PRESCRIPTION DRUG Cisplatin Cisplatin INJECTION INTRAVENOUS 20120419 ANDA ANDA091062 Mylan Institutional LLC CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 67457-425_601e6d97-95d4-4ef8-9c70-1abdb57e3df3 67457-425 HUMAN PRESCRIPTION DRUG Cisplatin Cisplatin INJECTION INTRAVENOUS 20120419 ANDA ANDA091062 Mylan Institutional LLC CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 67457-426_8f6d2394-ed41-4307-80de-28fbeea85bcb 67457-426 HUMAN PRESCRIPTION DRUG HALOPERIDOL LACTATE HALOPERIDOL LACTATE INJECTION, SOLUTION INTRAMUSCULAR 20110510 ANDA ANDA078347 Mylan Institutional LLC HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] 67457-427_99315f03-ebbe-4879-97e5-7b9352c9c297 67457-427 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION INTRAMUSCULAR; INTRAVENOUS 20080312 ANDA ANDA065407 Mylan Institutional LLC TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 67457-428_1454cd5d-3df9-4f07-8e00-830844a0f8b3 67457-428 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION INTRAMUSCULAR; INTRAVENOUS 20110510 ANDA ANDA065407 Mylan Institutional LLC TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 67457-429_4a2f8f58-5b87-44f9-aa33-28efd5064293 67457-429 HUMAN PRESCRIPTION DRUG Ifosfamide Ifosfamide INJECTION, SOLUTION INTRAVENOUS 20121127 ANDA ANDA201689 Mylan Institutional LLC IFOSFAMIDE 50 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] 67457-430_8d56d4aa-61a1-4fcf-a067-8c584823ad18 67457-430 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION INTRAVENOUS 20081101 ANDA ANDA078520 Mylan Institutional LLC PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 67457-431_d30f4706-0bbc-4dd4-aa1d-51173270ccbe 67457-431 HUMAN PRESCRIPTION DRUG Vinorelbine Vinorelbine INJECTION, SOLUTION INTRAVENOUS 20120901 ANDA ANDA200148 Mylan Institutional LLC VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 67457-432_99315f03-ebbe-4879-97e5-7b9352c9c297 67457-432 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION INTRAMUSCULAR; INTRAVENOUS 20080312 ANDA ANDA065407 Mylan Institutional LLC TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 67457-433_6d429238-3064-45d5-af55-3cbf22e53d58 67457-433 HUMAN PRESCRIPTION DRUG Famotidine Famotidine INJECTION INTRAVENOUS 20080626 ANDA ANDA078642 Mylan Institutional LLC FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 67457-434_0670b0a1-8b62-4314-b681-768437c448a2 67457-434 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION INTRAVENOUS 20110930 ANDA ANDA091540 Mylan Institutional LLC PACLITAXEL 300 mg/50mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 67457-436_bb405a38-3e4e-49af-b30d-fb728f209022 67457-436 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20111029 ANDA ANDA200170 Mylan Institutional LLC DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 67457-437_ba85f48b-1ffa-432f-8384-c4becb9f872b 67457-437 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120821 ANDA ANDA091406 Mylan Institutional LLC DOXYCYCLINE HYCLATE 100 mg/10mL 67457-438_b2017e7b-8edf-4f86-87a7-322b64e30dec 67457-438 HUMAN PRESCRIPTION DRUG VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110511 ANDA ANDA090243 Mylan Institutional LLC VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 67457-442_5a707c9a-845a-4741-b5d1-a8a1fc1c55c8 67457-442 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20120809 ANDA ANDA091358 Mylan Institutional LLC OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 67457-443_4a2f8f58-5b87-44f9-aa33-28efd5064293 67457-443 HUMAN PRESCRIPTION DRUG Ifosfamide Ifosfamide INJECTION, SOLUTION INTRAVENOUS 20121127 ANDA ANDA201689 Mylan Institutional LLC IFOSFAMIDE 50 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] 67457-444_51f59d64-76b8-4edb-b127-277621cfe029 67457-444 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078595 Mylan Institutional LLC FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 67457-445_7aa6ddc9-8ce4-4080-ac10-845a6b5bdd39 67457-445 HUMAN PRESCRIPTION DRUG Rifampin Rifampin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080523 ANDA ANDA065421 Mylan Institutional LLC RIFAMPIN 600 mg/10mL Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 67457-446_8d56d4aa-61a1-4fcf-a067-8c584823ad18 67457-446 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION INTRAVENOUS 20081101 ANDA ANDA078520 Mylan Institutional LLC PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 67457-447_51f59d64-76b8-4edb-b127-277621cfe029 67457-447 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078595 Mylan Institutional LLC FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] 67457-448_6d429238-3064-45d5-af55-3cbf22e53d58 67457-448 HUMAN PRESCRIPTION DRUG Famotidine Famotidine INJECTION INTRAVENOUS 20080626 ANDA ANDA078641 Mylan Institutional LLC FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 67457-449_0670b0a1-8b62-4314-b681-768437c448a2 67457-449 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION INTRAVENOUS 20110930 ANDA ANDA091540 Mylan Institutional LLC PACLITAXEL 100 mg/16.7mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 67457-450_69aee660-f40b-46e8-97de-0cfc2caf4377 67457-450 HUMAN PRESCRIPTION DRUG Cladribine Cladribine INJECTION INTRAVENOUS 20110710 ANDA ANDA200510 Mylan Institutional LLC CLADRIBINE 1 mg/mL Purine Antimetabolite [EPC] 67457-451_8efa6c2f-2221-47ae-a60d-7fcca4061be0 67457-451 HUMAN PRESCRIPTION DRUG Cladribine Cladribine INJECTION INTRAVENOUS 20111007 ANDA ANDA200510 Mylan Institutional LLC CLADRIBINE 1 mg/mL Purine Antimetabolite [EPC] 67457-452_8eb6d1e3-267f-4b87-8e97-8e51da741d80 67457-452 HUMAN PRESCRIPTION DRUG Cytarabine Cytarabine INJECTION INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS 20120131 ANDA ANDA201784 Mylan Institutional LLC CYTARABINE 2 g/20mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 67457-454_a6463842-d20c-4552-adee-c4a1d5de8cbc 67457-454 HUMAN PRESCRIPTION DRUG Cytarabine Cytarabine INJECTION INTRAVENOUS; SUBCUTANEOUS 20111214 ANDA ANDA200914 Mylan Institutional LLC CYTARABINE 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 67457-456_63b9c250-88d2-4b24-83f4-5b8ce14ee95c 67457-456 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION, SOLUTION INTRAVENOUS 20120203 ANDA ANDA078289 Mylan Institutional LLC ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 67457-457_6d429238-3064-45d5-af55-3cbf22e53d58 67457-457 HUMAN PRESCRIPTION DRUG Famotidine Famotidine INJECTION INTRAVENOUS 20080626 ANDA ANDA078641 Mylan Institutional LLC FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 67457-462_45f4931e-56db-41d5-83c1-7a0be8215d1b 67457-462 HUMAN PRESCRIPTION DRUG GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA200145 Mylan Institutional LLC GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 67457-463_45f4931e-56db-41d5-83c1-7a0be8215d1b 67457-463 HUMAN PRESCRIPTION DRUG GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA200145 Mylan Institutional LLC GEMCITABINE HYDROCHLORIDE 2 g/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 67457-464_45f4931e-56db-41d5-83c1-7a0be8215d1b 67457-464 HUMAN PRESCRIPTION DRUG GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA200145 Mylan Institutional LLC GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 67457-465_26308cf7-b6db-4f5f-8894-373597a3d910 67457-465 HUMAN PRESCRIPTION DRUG methotrexate sodium methotrexate sodium INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Mylan Institutional LLC METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 67457-466_0ab21edf-c92c-4acd-a7ea-0734c880f7e1 67457-466 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Mylan Institutional LLC METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 67457-467_0ab21edf-c92c-4acd-a7ea-0734c880f7e1 67457-467 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Mylan Institutional LLC METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 67457-468_a7bb542e-29f6-4b99-8fa3-f9e5de822a6e 67457-468 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin POWDER, FOR SOLUTION INTRAVENOUS 20120809 ANDA ANDA200979 Mylan Institutional LLC OXALIPLATIN 50 mg/10mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 67457-469_5a707c9a-845a-4741-b5d1-a8a1fc1c55c8 67457-469 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20120809 ANDA ANDA091358 Mylan Institutional LLC OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 67457-471_0670b0a1-8b62-4314-b681-768437c448a2 67457-471 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION INTRAVENOUS 20110930 ANDA ANDA091540 Mylan Institutional LLC PACLITAXEL 30 mg/5mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 67457-473_1454cd5d-3df9-4f07-8e00-830844a0f8b3 67457-473 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION INTRAMUSCULAR; INTRAVENOUS 20110510 ANDA ANDA065407 Mylan Institutional LLC TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 67457-474_72d829bb-4c11-4ccb-8a3d-005d7c1d6ffe 67457-474 HUMAN PRESCRIPTION DRUG TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120829 ANDA ANDA091542 Mylan Institutional LLC TOPOTECAN HYDROCHLORIDE 4 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 67457-475_b2017e7b-8edf-4f86-87a7-322b64e30dec 67457-475 HUMAN PRESCRIPTION DRUG VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110511 ANDA ANDA090243 Mylan Institutional LLC VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 67457-476_a7bb542e-29f6-4b99-8fa3-f9e5de822a6e 67457-476 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin POWDER, FOR SOLUTION INTRAVENOUS 20120809 ANDA ANDA200979 Mylan Institutional LLC OXALIPLATIN 100 mg/20mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 67457-477_63b9c250-88d2-4b24-83f4-5b8ce14ee95c 67457-477 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION, SOLUTION INTRAVENOUS 20120203 ANDA ANDA078289 Mylan Institutional LLC ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] 67457-478_bb405a38-3e4e-49af-b30d-fb728f209022 67457-478 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20111029 ANDA ANDA200170 Mylan Institutional LLC DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] 67457-479_d30f4706-0bbc-4dd4-aa1d-51173270ccbe 67457-479 HUMAN PRESCRIPTION DRUG Vinorelbine Vinorelbine INJECTION, SOLUTION INTRAVENOUS 20120901 ANDA ANDA200148 Mylan Institutional LLC VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 67457-480_6b7654e0-62c0-4e62-bbb9-9aa4f8032dc9 67457-480 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201530 Mylan Institutional LLC METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 67457-481_98de626d-80d1-4da0-b530-08bb45e14d92 67457-481 HUMAN PRESCRIPTION DRUG vinorelbine vinorelbine INJECTION, SOLUTION INTRAVENOUS 20120901 ANDA ANDA200148 Mylan Institutional LLC VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 67457-482_98de626d-80d1-4da0-b530-08bb45e14d92 67457-482 HUMAN PRESCRIPTION DRUG vinorelbine vinorelbine INJECTION, SOLUTION INTRAVENOUS 20120901 ANDA ANDA200148 Mylan Institutional LLC VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] 67457-483_572896a4-c8fe-49ef-be5f-1cde07766629 67457-483 HUMAN PRESCRIPTION DRUG Dexamethasone sodium phosphate Dexamethasone sodium phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110511 ANDA ANDA040802 Mylan Institutional LLC DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 67457-484_572896a4-c8fe-49ef-be5f-1cde07766629 67457-484 HUMAN PRESCRIPTION DRUG Dexamethasone sodium phosphate Dexamethasone sodium phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Mylan Institutional LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 67457-485_0ab21edf-c92c-4acd-a7ea-0734c880f7e1 67457-485 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Mylan Institutional LLC METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 67457-486_0ab21edf-c92c-4acd-a7ea-0734c880f7e1 67457-486 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Mylan Institutional LLC METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 67457-491_5677d335-1e80-4ec0-b1a9-8143856e7a34 67457-491 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION INTRAVENOUS 20111109 ANDA ANDA091063 Mylan Institutional LLC CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 67457-492_5677d335-1e80-4ec0-b1a9-8143856e7a34 67457-492 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION INTRAVENOUS 20111109 ANDA ANDA091063 Mylan Institutional LLC CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 67457-493_5677d335-1e80-4ec0-b1a9-8143856e7a34 67457-493 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION INTRAVENOUS 20111109 ANDA ANDA091063 Mylan Institutional LLC CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 67457-494_5677d335-1e80-4ec0-b1a9-8143856e7a34 67457-494 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION INTRAVENOUS 20111109 ANDA ANDA091063 Mylan Institutional LLC CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 67457-495_7c3713bd-288b-42df-94e2-8873675e9f2b 67457-495 HUMAN PRESCRIPTION DRUG Fludarabine Phosphate Fludarabine Phosphate INJECTION INTRAVENOUS 20111222 ANDA ANDA200647 Mylan Institutional LLC FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 67457-505_dcebf389-1c64-4f3e-b06a-f151ab3126dd 67457-505 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION INFILTRATION; INTRAVENOUS 20100912 ANDA ANDA091056 Mylan Institutional LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 67457-506_dcebf389-1c64-4f3e-b06a-f151ab3126dd 67457-506 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION INFILTRATION; INTRAVENOUS 20100912 ANDA ANDA091056 Mylan Institutional LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 67457-507_dcebf389-1c64-4f3e-b06a-f151ab3126dd 67457-507 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION INFILTRATION; INTRAVENOUS 20100912 ANDA ANDA091056 Mylan Institutional LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 67457-510_ce77e0be-37bc-43ca-a224-6ebd8f6baa65 67457-510 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION INFILTRATION; INTRAVENOUS 20101001 ANDA ANDA091058 Mylan Institutional LLC LIDOCAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 67457-511_ce77e0be-37bc-43ca-a224-6ebd8f6baa65 67457-511 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION EPIDURAL; INFILTRATION; INTRACAUDAL 20101001 ANDA ANDA091058 Mylan Institutional LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 67457-521_3008018f-a493-47d3-b0f4-daa70399d4fc 67457-521 HUMAN PRESCRIPTION DRUG piperacillin and tazobactam piperacillin and tazobactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140816 ANDA ANDA065458 Mylan Institutional LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 67457-522_3008018f-a493-47d3-b0f4-daa70399d4fc 67457-522 HUMAN PRESCRIPTION DRUG piperacillin and tazobactam piperacillin and tazobactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140816 ANDA ANDA065458 Mylan Institutional LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 67457-523_3008018f-a493-47d3-b0f4-daa70399d4fc 67457-523 HUMAN PRESCRIPTION DRUG piperacillin and tazobactam piperacillin and tazobactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140816 ANDA ANDA065458 Mylan Institutional LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 67457-524_ced73a8a-532f-45d0-b820-1fac8b746346 67457-524 HUMAN PRESCRIPTION DRUG ibandronate sodium ibandronate sodium INJECTION, SOLUTION INTRAVENOUS 20140902 ANDA ANDA202671 Mylan Institutional LLC IBANDRONATE SODIUM 3 mg/3mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 67457-560_dcebf389-1c64-4f3e-b06a-f151ab3126dd 67457-560 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION INFILTRATION; INTRAVENOUS 20100912 ANDA ANDA091056 Mylan Institutional LLC LIDOCAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 67457-571_c9802f33-2ece-445b-9201-3138de6a6c92 67457-571 HUMAN PRESCRIPTION DRUG VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110511 ANDA ANDA090243 Mylan Institutional LLC VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 67457-572_c9802f33-2ece-445b-9201-3138de6a6c92 67457-572 HUMAN PRESCRIPTION DRUG VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110511 ANDA ANDA090243 Mylan Institutional LLC VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 67457-573_26fd96eb-9128-4ae1-bc61-2cf0f2a060b8 67457-573 HUMAN PRESCRIPTION DRUG Rocuronium Bromide rocuronium bromide INJECTION INTRAVENOUS 20140929 ANDA ANDA079199 Mylan Institutional LLC ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 67457-574_26fd96eb-9128-4ae1-bc61-2cf0f2a060b8 67457-574 HUMAN PRESCRIPTION DRUG Rocuronium Bromide rocuronium bromide INJECTION INTRAVENOUS 20140929 ANDA ANDA079199 Mylan Institutional LLC ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] 67457-579_7349a5f7-0b8d-4055-98b2-3b4b2629dd1f 67457-579 HUMAN PRESCRIPTION DRUG Melphalan Hydrochloride Melphalan Hydrochloride KIT 20140929 ANDA ANDA090270 Mylan Institutional LLC 67457-582_6fd85033-baaa-48f5-a369-143530de8e50 67457-582 HUMAN PRESCRIPTION DRUG fondaparinux sodium fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20140514 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 2.5 mg/.5mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 67457-583_6fd85033-baaa-48f5-a369-143530de8e50 67457-583 HUMAN PRESCRIPTION DRUG fondaparinux sodium fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20140514 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 5 mg/.4mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 67457-584_6fd85033-baaa-48f5-a369-143530de8e50 67457-584 HUMAN PRESCRIPTION DRUG fondaparinux sodium fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20140514 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 7.5 mg/.6mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 67457-585_6fd85033-baaa-48f5-a369-143530de8e50 67457-585 HUMAN PRESCRIPTION DRUG fondaparinux sodium fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20140501 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 10 mg/.8mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 67457-592_4a2b35dc-5b64-48b6-840c-dc3fc51f9b88 67457-592 HUMAN PRESCRIPTION DRUG Arixtra fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20140514 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 2.5 mg/.5mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 67457-593_4a2b35dc-5b64-48b6-840c-dc3fc51f9b88 67457-593 HUMAN PRESCRIPTION DRUG Arixtra fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20140514 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 5 mg/.4mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 67457-594_4a2b35dc-5b64-48b6-840c-dc3fc51f9b88 67457-594 HUMAN PRESCRIPTION DRUG Arixtra fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20140514 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 7.5 mg/.6mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 67457-595_4a2b35dc-5b64-48b6-840c-dc3fc51f9b88 67457-595 HUMAN PRESCRIPTION DRUG Arixtra fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20140501 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 10 mg/.8mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] 67457-599_47a284bb-cf9c-4765-adb9-0ed84f3cb604 67457-599 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride naloxone hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20141217 ANDA ANDA204997 Mylan Institutional LLC NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 67457-608_cea63fe8-1839-4bbf-a818-5a549abbf073 67457-608 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION INTRAVENOUS 20111109 ANDA ANDA091063 Mylan Institutional LLC CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] 67457-609_9273052f-cd52-4452-b3eb-a78984b852ad 67457-609 HUMAN PRESCRIPTION DRUG Ifosfamide Ifosfamide INJECTION, SOLUTION INTRAVENOUS 20121127 ANDA ANDA201689 Mylan Institutional LLC IFOSFAMIDE 50 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] 67457-610_0405479b-5075-42cd-a71b-440a413203e2 67457-610 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION INTRAVENOUS 20081101 ANDA ANDA078520 Mylan Institutional LLC PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 67457-611_a548402e-f9bd-4de2-a67a-535649a7cdfa 67457-611 HUMAN PRESCRIPTION DRUG vancomycin hydrochloride vancomycin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065397 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 67457-612_a548402e-f9bd-4de2-a67a-535649a7cdfa 67457-612 HUMAN PRESCRIPTION DRUG vancomycin hydrochloride vancomycin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065397 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 67457-613_d1e08b5b-7223-467d-9bc8-dd4a04ed64da 67457-613 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065432 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 5 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 67457-614_a759b52d-48f8-4e8a-aaaf-e2f88298f617 67457-614 HUMAN PRESCRIPTION DRUG Vancomycin hydrochloride Vancomycin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110919 ANDA ANDA091554 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 10 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 67457-615_9c5179ca-1a55-4e41-8994-ed0ce2489f34 67457-615 HUMAN PRESCRIPTION DRUG cytarabine Cytarabine INJECTION INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS 20120131 ANDA ANDA201784 Mylan Institutional LLC CYTARABINE 2 g/20mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 67465-0001_e6aa8897-c0c7-4676-8618-5cd6b107e37f 67465-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20051001 UNAPPROVED MEDICAL GAS Mt. Vernon Community Pharmacy, Inc. d/b/a The Medicine Shoppe OXYGEN 99 L/100L 67467-182_aae10ecc-a31e-d699-eff2-7540089705c4 67467-182 PLASMA DERIVATIVE Wilate - von Willebrand Factor/Coagulation Factor VIII Complex (Human) von Willebrand Factor/Coagulation Factor VIII Complex (Human) POWDER, FOR SOLUTION INTRAVENOUS 20091204 BLA BLA125251 Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. ANTIHEMOPHILIC FACTOR HUMAN; VON WILLEBRAND FACTOR HUMAN 100; 100 [iU]/mL; [iU]/mL Human Antihemophilic Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Factor VIII [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Platelet Aggregation [PE],Increased Coagulation Activity [PE],von Willebrand Factor [Chemical/Ingredient],Blood Coagulation Factors [Chemical/Ingredient] 67467-623_0115cedc-4781-0619-f8c9-82e8199df443 67467-623 HUMAN PRESCRIPTION DRUG Albumin (Human) Albumin Human SOLUTION INTRAVENOUS 20061017 BLA BLA125154 Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. ALBUMIN (HUMAN) 50 g/1000mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 67467-633_7fc09e55-b28d-9197-a808-a6b341102f06 67467-633 HUMAN PRESCRIPTION DRUG Albumin (Human) Albumin Human SOLUTION INTRAVENOUS 20061017 BLA BLA125154 Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. ALBUMIN (HUMAN) 200 g/1000mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 67467-643_be20e36e-0b6e-7b05-82ac-7078b2befd03 67467-643 HUMAN PRESCRIPTION DRUG Albumin (Human) Albumin Human SOLUTION INTRAVENOUS 20061017 BLA BLA125154 Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. ALBUMIN (HUMAN) 250 g/1000mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 67467-843_0fe33130-c3e4-4baa-db1f-4ce138e6c2e5 67467-843 HUMAN PRESCRIPTION DRUG Octagam Immune Globulin (Human) Immune Globulin SOLUTION INTRAVENOUS 20040521 BLA BLA125062 Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. HUMAN IMMUNOGLOBULIN G 50 mg/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 67473-103_07e06871-2141-46b7-84b2-dbd169c52128 67473-103 HUMAN OTC DRUG SHENG CHUN HERBAL Pain Relieving MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20051101 OTC MONOGRAPH NOT FINAL part348 Sheng Chun Tang Pharmaceutical Industrial Co., Ltd MENTHOL; METHYL SALICYLATE .05; .01 g/g; g/g 67475-112_1934f220-5c1d-4b0a-b5cf-f3e98c672542 67475-112 HUMAN OTC DRUG Golden Sunshine Far Infrared HOT Herbal Topical Analgesic PATCH TOPICAL 20040802 OTC MONOGRAPH NOT FINAL part348 Golden Sunshine International, Inc. MENTHOL; METHYL SALICYLATE .03; .005 g/g; g/g 67475-114_5d9674de-4b4e-4313-8b77-7672277ace5c 67475-114 HUMAN OTC DRUG Golden Sunshine Herbal Topical Analgesic SPRAY TOPICAL 20040802 OTC MONOGRAPH NOT FINAL part348 Golden Sunshine International, Inc. MENTHOL; METHYL SALICYLATE .00781; .03 g/g; g/g 67475-123_29fe4406-528a-4b2d-be62-2e2438bf80f2 67475-123 HUMAN OTC DRUG Golden Sunshine Herbal Topical Analgesic CREAM TOPICAL 20100615 OTC MONOGRAPH NOT FINAL part348 Golden Sunshine International, Inc. MENTHOL; METHYL SALICYLATE .02; .005 g/g; g/g 67475-211_f3b7da5b-8739-4014-9d29-a3e2443c8176 67475-211 HUMAN OTC DRUG Golden Sunshine Far Infrared Herbal Topical Analgesic PASTE TOPICAL 20090223 OTC MONOGRAPH NOT FINAL part348 Golden Sunshine International, Inc. MENTHOL; METHYL SALICYLATE .03; .03 g/g; g/g 67475-212_c8e34306-2e3f-43f7-a790-6a6336df24e9 67475-212 HUMAN OTC DRUG Golden Sunshine Far Infrared COOL Herbal Topical Analgesic PATCH TOPICAL 20040802 OTC MONOGRAPH NOT FINAL part348 Golden Sunshine International, Inc. MENTHOL; METHYL SALICYLATE .03; .005 g/g; g/g 67475-312_a2e6005a-a1c9-4a2a-b692-b16147a7f461 67475-312 HUMAN OTC DRUG PAIN Terminator Analgesic Topical Analgesic PATCH TOPICAL 20060518 OTC MONOGRAPH NOT FINAL part348 Golden Sunshine International, Inc. MENTHOL; METHYL SALICYLATE .03; .005 g/g; g/g 67475-313_8965c3b0-43ac-400d-b41d-a6e52dff29a3 67475-313 HUMAN OTC DRUG PAIN Terminator Analgesic Topical Analgesic CREAM TOPICAL 20090223 OTC MONOGRAPH NOT FINAL part348 Golden Sunshine International, Inc. MENTHOL; METHYL SALICYLATE .02; .005 g/g; g/g 67490-0001_1ba22c62-74c2-42de-aec3-a4eff6f8a1ea 67490-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091112 UNAPPROVED MEDICAL GAS Scott Medical Supply Inc. OXYGEN 99 L/100L 67491-7777_21091b5b-5aee-4e6f-ae8b-f067b107d9db 67491-7777 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20021015 UNAPPROVED MEDICAL GAS Med-Core Services, Inc. OXYGEN 99 L/100L 67492-104_eb2fb9c9-ab4b-4c5f-ad2d-53b1b87a80ba 67492-104 HUMAN OTC DRUG Calmol 4 Zinc Oxide and Cocoa Butter SUPPOSITORY RECTAL 20060513 OTC MONOGRAPH FINAL part346 Resical Inc. COCOA BUTTER; ZINC OXIDE 2052; 270 mg/1; mg/1 67492-105_c98f421e-503e-42f2-83ba-77bbb5870239 67492-105 HUMAN OTC DRUG Resinol PETROLATUM and RESORCINOL OINTMENT TOPICAL 20020629 OTC MONOGRAPH NOT FINAL part348 ResiCal, Inc. PETROLATUM; RESORCINOL 55; 2 g/100g; g/100g 67493-0009_5f396ef0-7a2f-4caa-89f2-820b0c986967 67493-0009 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020926 UNAPPROVED MEDICAL GAS Buckeye Home Health Center, Inc. OXYGEN 99 L/100L 67510-0005_281d03f2-ce0f-4cc0-b3a7-048d7d094f72 67510-0005 HUMAN OTC DRUG Muscle and Joint Menthol GEL TOPICAL 20110811 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. MENTHOL 2.5 g/100g 67510-0008_7238bb4f-cde7-4a16-b0f3-51faa9b9c67b 67510-0008 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20111123 OTC MONOGRAPH FINAL part343 Kareway Product, Inc. ASPIRIN 325 mg/1 67510-0011_11323c7e-ab6e-447c-9cfe-68aed7a5e7bb 67510-0011 HUMAN OTC DRUG Mint Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20110815 OTC MONOGRAPH FINAL part355 Kareway Product, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 67510-0012_3d1c92e6-ae26-4e8c-90c4-c8cea73322f4 67510-0012 HUMAN OTC DRUG Regular Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20110815 OTC MONOGRAPH FINAL part355 Kareway Product, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 67510-0016_b1933159-1485-4898-b563-61e4efece407 67510-0016 HUMAN OTC DRUG Antibacterial Gold Triclocarban SOAP TOPICAL 20110907 OTC MONOGRAPH NOT FINAL part333E Kareway Product, Inc. TRICLOCARBAN .1 g/100g 67510-0017_e785d52c-f47a-4a29-bad1-5d44c0bfe09c 67510-0017 HUMAN OTC DRUG Antibacterial Beauty Triclocarban SOAP TOPICAL 20110907 OTC MONOGRAPH NOT FINAL part333E Kareway Product, Inc. TRICLOCARBAN .1 g/100g 67510-0026_7e224d37-7b46-4440-a283-d6b8b79f0bcd 67510-0026 HUMAN OTC DRUG Medicated Pain Relief Hot Menthol, Capsicum extract PATCH TOPICAL 20110916 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. CAPSICUM OLEORESIN; MENTHOL .166; 29.44 mg/1; mg/1 67510-0030_0e4685a5-0970-4167-87b7-c5c4d43ea248 67510-0030 HUMAN OTC DRUG Cold and Hot Pain Relief Menthol PATCH TOPICAL 20110912 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. MENTHOL 400 mg/1 67510-0043_feae241c-d9a2-4328-99bc-7a7e50e3b8d4 67510-0043 HUMAN OTC DRUG Pine Salt Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110822 OTC MONOGRAPH FINAL part355 Kareway Product, Inc. SODIUM FLUORIDE 2.2 mg/g 67510-0054_be678cc6-c06b-459e-b831-08694aa9ce70 67510-0054 HUMAN OTC DRUG Anti Itch Diphenhydramine HCl, Zinc acetate CREAM TOPICAL 20110811 OTC MONOGRAPH FINAL part336 Kareway Product, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 67510-0055_64e859d4-1ed6-4b9f-9dbe-dd45ef7aa1b2 67510-0055 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20120724 OTC MONOGRAPH FINAL part333B Kareway Product, Inc. BACITRACIN ZINC 500 [USP'U]/g 67510-0056_34a8ecee-2848-4827-9b4e-910a7aaed43d 67510-0056 HUMAN OTC DRUG Hemorrhoidal MINERAL OIL,PETROLATUM,PHENYLEPHRINE OINTMENT TOPICAL 20120702 OTC MONOGRAPH FINAL part346 Kareway Product, Inc. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 71.9; .25 g/100g; g/100g; g/100g 67510-0057_71baab80-d653-4013-ac1d-3b7dae4c46f8 67510-0057 HUMAN OTC DRUG Tolnaftate Tolnaftate CREAM TOPICAL 20110811 OTC MONOGRAPH FINAL part333C Kareway Product, Inc. TOLNAFTATE 1 g/100g 67510-0058_9e235599-4d71-41b1-8743-d647468b19f9 67510-0058 HUMAN OTC DRUG Oral Pain Relief Oral Pain Reliever GEL TOPICAL 20110717 OTC MONOGRAPH NOT FINAL part356 Kareway Product, Inc. BENZOCAINE 200 mg/g 67510-0062_a316a6dd-c83c-4cd7-a0d5-4a169c4c3ab9 67510-0062 HUMAN OTC DRUG Redness reliever tetrahydrozoline HCl LIQUID OPHTHALMIC 20110811 OTC MONOGRAPH FINAL part349 Kareway Product, Inc. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 67510-0063_82004441-694e-44b1-ba1d-75b159ed8d1b 67510-0063 HUMAN OTC DRUG Tears lubricant glycerin, hypromelloses, polyethylene glycol 400 LIQUID OPHTHALMIC 20100829 OTC MONOGRAPH FINAL part349 Kareway Product, Inc. GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2; 2; 10 mg/mL; mg/mL; mg/mL 67510-0064_fbe34271-e49c-48b2-adfe-406f104cd300 67510-0064 HUMAN OTC DRUG Advanced relief dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl LIQUID OPHTHALMIC 20110811 OTC MONOGRAPH FINAL part349 Kareway Product, Inc. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL 67510-0065_fafbe0ef-db8b-4ce2-a431-b464dd391fb8 67510-0065 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. HYDROCORTISONE 1 h/100g 67510-0066_5fd00e8b-9d7f-42d0-a156-42a92f34d567 67510-0066 HUMAN OTC DRUG Antibiotic Neomycin Sulfate OINTMENT TOPICAL 20110811 OTC MONOGRAPH FINAL part333B Kareway Product, Inc. NEOMYCIN SULFATE 3.5 mg/g 67510-0068_48193a7f-daa2-4eb5-8820-a8d6fc67b4a5 67510-0068 HUMAN OTC DRUG Nasal Decongestant Oxymetazoline HCl SPRAY NASAL 20110812 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 67510-0069_91f22696-59ac-49b1-8356-7407295fb60d 67510-0069 HUMAN OTC DRUG Nasal Decongestant Extra Moisturizing Oxymetazoline HCl SPRAY NASAL 20110812 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 67510-0070_4d4d5279-f24f-47b4-aac0-79fef99b7006 67510-0070 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B OINTMENT TOPICAL 20110810 OTC MONOGRAPH FINAL part333B Kareway Product, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 67510-0081_97f69d01-0ab7-4065-90ac-f77363e41169 67510-0081 HUMAN OTC DRUG Face and Body Sunscreen Octinoxate and Titanium dioxide LOTION TOPICAL 20130124 OTC MONOGRAPH NOT FINAL part352 Kareway Product, Inc. OCTINOXATE; TITANIUM DIOXIDE 7; 2.8 g/100mL; g/100mL 67510-0082_1e2791e7-8a1e-4b54-96a0-2313bf4e5f94 67510-0082 HUMAN OTC DRUG Kids Sunscreen Octinoxate and Titanium Dioxide LOTION TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Kareway Product, Inc. OCTINOXATE; TITANIUM DIOXIDE 7; 2.8 g/100mL; g/100mL 67510-0083_adc62a58-e025-4231-a80a-4c1b4073c755 67510-0083 HUMAN OTC DRUG Sport Sunblock Octinoxate and Titanium Dioxide LOTION TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part352 Kareway Product, Inc. OCTINOXATE; TITANIUM DIOXIDE 7; 2.8 g/100mL; g/100mL 67510-0085_812af3dc-733f-4833-bb37-c7fab12e8827 67510-0085 HUMAN OTC DRUG Cold and Hot Pain Relief Sleeve Menthol PATCH TOPICAL 20120419 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. MENTHOL 400 mg/1 67510-0152_84eeab00-7b87-4312-b172-a645485b3b69 67510-0152 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110811 OTC MONOGRAPH NOT FINAL part343 Kareway Product, Inc. ACETAMINOPHEN 500 mg/1 67510-0153_84eeab00-7b87-4312-b172-a645485b3b69 67510-0153 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110811 OTC MONOGRAPH NOT FINAL part343 Kareway Product, Inc. ACETAMINOPHEN 500 mg/1 67510-0154_d2524712-3485-4e1c-9e7b-2cd5bc8df6fc 67510-0154 HUMAN OTC DRUG Acetaminophen PM Acetaminophen, diphenhydramine HCl TABLET ORAL 20110128 OTC MONOGRAPH NOT FINAL part343 Kareway Product, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 67510-0156_ee1471a9-f299-4373-8754-a1acca87d16a 67510-0156 HUMAN OTC DRUG Multi Sympton Cold Day Night Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20120501 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. 67510-0158_55dc0484-2c66-4aed-a077-4b78f92d4810 67510-0158 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET ORAL 20110818 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 67510-0159_1cf99cf6-1836-4888-a5cc-f7ea5c6bb5f0 67510-0159 HUMAN OTC DRUG Allergy Relief CHLORPHENIRAMINE MALEATE TABLET ORAL 20110818 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 67510-0160_5e9a6c00-38aa-4e50-aa1e-f67f20f15e8b 67510-0160 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl TABLET ORAL 20110818 OTC MONOGRAPH FINAL part338 Kareway Product, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 67510-0171_786f3341-b5f3-496b-b249-7f935f8445c6 67510-0171 HUMAN OTC DRUG Gentle Laxative BIisacodyl TABLET, COATED ORAL 20120215 OTC MONOGRAPH NOT FINAL part334 Kareway Product, Inc. BISACODYL 5 mg/1 67510-0172_a16753f1-eb22-4488-9d22-a954c1cc4a13 67510-0172 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20120901 OTC MONOGRAPH FINAL part332 Kareway Product, Inc. DIMETHICONE 125 mg/1 67510-0251_9eb88e7a-f54f-4a8f-a3aa-feeebbc88f61 67510-0251 HUMAN OTC DRUG Alcohol Prep Pads isopropyl alcohol SWAB TOPICAL 20130820 OTC MONOGRAPH NOT FINAL part333A Kareway Product, Inc. ISOPROPYL ALCOHOL 70 1/1 67510-0301_cfd90953-404e-4944-8126-5a6406fb640c 67510-0301 HUMAN OTC DRUG Medicated Pain Relief Menthol PATCH TOPICAL 20110912 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. MENTHOL 428.5 mg/1 67510-0302_2456d211-71f9-4ce6-8a21-add3a15b040d 67510-0302 HUMAN OTC DRUG Medicated Pain Relief Menthol PATCH TOPICAL 20110907 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. MENTHOL 428.5 mg/1 67510-0303_32c033cf-319f-4e39-bf43-4bcc985a56ba 67510-0303 HUMAN OTC DRUG Capsaicin Pain Relief Capsaicin PATCH TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. CAPSAICIN .702 mg/1 67510-0305_ba741f37-ade4-4b06-a0df-8a3a32edd17f 67510-0305 HUMAN OTC DRUG Pain Relief DL-Camphor, L-Menthol, Methyl Salicylate patch PATCH TOPICAL 20120125 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE .4; 1.8; 2 mg/1; mg/1; mg/1 67510-0378_71bc154c-4e50-4e8a-97bf-87f1ee87d126 67510-0378 HUMAN OTC DRUG Tinted BB Octinoxate and Titanium dioxide CREAM TOPICAL 20131011 OTC MONOGRAPH FINAL part352 Kareway Product, Inc. OCTINOXATE; TITANIUM DIOXIDE 6; 8.5 mg/100mg; mg/100mg 67510-0487_16bde801-42e2-4993-bebf-1a26e18394e1 67510-0487 HUMAN OTC DRUG Hand Sanitizer ALCOHOL GEL TOPICAL 20131007 OTC MONOGRAPH NOT FINAL part333E Kareway Product, Inc. ALCOHOL 62 mL/100mL 67510-0501_e1147c11-b7c7-4426-8dae-835da9205faa 67510-0501 HUMAN OTC DRUG Night Time Cold/Flu Relief Original Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110826 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 67510-0502_28a6585c-656a-41b0-abcb-fcf95b9ac65a 67510-0502 HUMAN OTC DRUG Diaper Rash Zinc Oxide CREAM TOPICAL 20110825 OTC MONOGRAPH FINAL part347 Kareway Product, Inc. ZINC OXIDE .1 g/g 67510-0503_fb220855-dc51-43cf-8a9b-f04ed170a667 67510-0503 HUMAN OTC DRUG Night Time Cough Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120711 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 6.25 mg/15mL; mg/15mL 67510-0505_1a79d259-9965-4ace-ad33-2bc01ba8f2ec 67510-0505 HUMAN OTC DRUG Pink Bismuth Bismuth Subsalicylate LIQUID ORAL 20110829 OTC MONOGRAPH FINAL part335 Kareway Product, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL 67510-0506_e039c466-6788-4aaf-b15b-275c2cfe796e 67510-0506 HUMAN OTC DRUG Tussin CF Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20110826 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 67510-0507_6038afb7-254e-4b5c-b586-f5833c75c8d3 67510-0507 HUMAN OTC DRUG Night Time Cold/Flu Relief Cherry Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110826 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 67510-0508_b9c37609-fab1-48bc-b9a2-64c67e9760d4 67510-0508 HUMAN OTC DRUG Childrens Non Aspirin Acetaminophen LIQUID ORAL 20110902 OTC MONOGRAPH NOT FINAL part343 Kareway Product, Inc. ACETAMINOPHEN 160 mg/5mL 67510-0521_9ea99d30-2c01-4899-8557-55ff3710818d 67510-0521 HUMAN OTC DRUG Night Time Gelcap Acetaminophen, Dextromethorphan, Doxylamine CAPSULE, LIQUID FILLED ORAL 20110601 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 10; 5 mg/1; mg/1; mg/1 67510-0523_57c0ea57-c0f3-48e1-a8bd-834047b7f839 67510-0523 HUMAN OTC DRUG Day Time Gelcap Acetaminophen, Dextromethorphan, Phenylephrine CAPSULE, LIQUID FILLED ORAL 20110601 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 67510-0526_0d5c9dfc-7adc-499d-8da9-0ccd034826bb 67510-0526 HUMAN OTC DRUG Tussin Chest Guaifenesin LIQUID ORAL 20110829 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. GUAIFENESIN 100 mg/5mL 67510-0527_c9e1677e-3bca-499d-beb1-309aeb11bd0b 67510-0527 HUMAN OTC DRUG Tussin DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20110826 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 67510-0544_f32e3302-f170-4be8-a351-8b383d43052d 67510-0544 HUMAN OTC DRUG Day Time Cold/Flu Relief Acetaminophen, Dextromethorphan, Phenylephrine LIQUID ORAL 20110906 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 67510-0557_4294707b-3c0b-4a75-96e0-61a18ba498d7 67510-0557 HUMAN OTC DRUG Nighttime Sleepaid Diphenhydramine Hydrochloride CAPSULE, GELATIN COATED ORAL 20141022 OTC MONOGRAPH FINAL part338 Kareway Product, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/21 67510-0631_6271f697-4234-4e31-818e-b9160c0e0f94 67510-0631 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B OINTMENT TOPICAL 20131212 OTC MONOGRAPH FINAL part333B Kareway Product, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 67510-0632_8769074a-6255-4fd7-848c-bc93999d601a 67510-0632 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. HYDROCORTISONE 1 g/100g 67510-0633_4ec1997f-e3e6-441e-863e-68f06818c667 67510-0633 HUMAN OTC DRUG Anti-Itch Diphenhydramine HCl, Zinc acetate CREAM TOPICAL 20131213 OTC MONOGRAPH FINAL part347 Kareway Product, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 67510-0634_dab5107b-62a3-4512-a0d5-dc8323660161 67510-0634 HUMAN OTC DRUG Muscle and Joint Menthol GEL TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. MENTHOL 2.5 g/100g 67510-0657_54143236-dd40-4f00-8d3f-6db2e3408e2e 67510-0657 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20110811 OTC MONOGRAPH FINAL part333C Kareway Product, Inc. CLOTRIMAZOLE 1 g/100g 67510-0659_13a08c90-44c8-4acf-bb01-06d0d9ae94b5 67510-0659 HUMAN OTC DRUG Muscle Rub Ultra Camphor,Menthol, methyl salicylate CREAM TOPICAL 20110811 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. CAMPHOR (NATURAL); MENTHOL; MENTHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g 67510-0662_9d3e152e-0ec1-4aa1-bcbe-0c413abfc2e0 67510-0662 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20110908 OTC MONOGRAPH FINAL part349 Kareway Product, Inc. WATER 99.05 mL/100mL 67510-0663_2a1549eb-704f-42ed-a54c-d73147215fba 67510-0663 HUMAN OTC DRUG Eye Lubricant polyethylene gloycol, propylene glycol LIQUID OPHTHALMIC 20121001 OTC MONOGRAPH FINAL part349 Kareway Product, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL 67510-0663_672d04af-0109-4b06-91f9-d98861679f06 67510-0663 HUMAN OTC DRUG Eye Lubricant polyethylene gloycol, propylene glycol LIQUID OPHTHALMIC 20120111 OTC MONOGRAPH FINAL part349 Kareway Product, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL 67510-0665_197ee658-8541-41eb-89a3-7db6da809652 67510-0665 HUMAN OTC DRUG Seasonal itchy and Red eye relief tetrahydrozoline HCl, Zinc sulfate LIQUID OPHTHALMIC 20131112 OTC MONOGRAPH FINAL part349 Kareway Product, Inc. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .05; .25 mg/mL; mg/mL 67510-0667_1131c892-2a86-4409-ba5d-39113222a3ee 67510-0667 HUMAN OTC DRUG Saline Nasal Sodium chloride SPRAY NASAL 20110207 UNAPPROVED DRUG OTHER Kareway Product, Inc. SODIUM CHLORIDE 6.5 mg/mL 67510-0670_969a2577-ac11-4818-a76d-eb0dc7323612 67510-0670 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20110912 OTC MONOGRAPH FINAL part333B Kareway Product, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g 67510-0672_8ed606be-41ee-42b4-a48d-260740d367e5 67510-0672 HUMAN OTC DRUG Vaporizing Chest Rub Camphor, Eucalyptus Oil, Menthol GEL TOPICAL 20110909 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 1 g/100g; g/100g; g/100g 67510-1501_489bf408-8a99-488b-b6ec-3901d8e9b3b5 67510-1501 HUMAN OTC DRUG Night Time Cold/Flu Relief Original Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120730 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 67510-1507_649e7b4c-23a5-4b95-8947-6a0afaa3701c 67510-1507 HUMAN OTC DRUG Night Time Cold/Flu Relief Cherry Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120711 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 67510-1561_704ed99a-5917-4bcc-a9ed-7a195f013060 67510-1561 HUMAN OTC DRUG Night Time Cold/Flu Relief Cherry Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20131212 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 67510-1562_d56b2225-d9de-4cca-8e6b-310a344a0b85 67510-1562 HUMAN OTC DRUG Night Time Cold/Flu Relief Original Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20131212 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 67510-9156_ee1471a9-f299-4373-8754-a1acca87d16a 67510-9156 HUMAN OTC DRUG Multi Sympton Cold Day Night Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20120501 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. 67512-224_c0949181-0e93-48cf-a2cd-1d4774a5f485 67512-224 HUMAN OTC DRUG La Roche Posay Redermic plus UV Intensive Daily Antiwrinkle Firming Fill In Care Avobenzone Octisalate Octocrylene LOTION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 La Roche-Posay Laboratoire Pharmaceutique AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.2; 2; 2.8 mL/40mL; mL/40mL; mL/40mL 67525-100_52898227-6686-4079-933e-279c4f211602 67525-100 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20050101 UNAPPROVED MEDICAL GAS Spectrum Gas Products, Inc OXYGEN 99 L/100L 67536-223_a9833cba-2a70-4a84-bde1-37e5452e7110 67536-223 HUMAN OTC DRUG Absorbine BACK Therapeutic Pain Relief MENTHOL PATCH TOPICAL 20131010 OTC MONOGRAPH NOT FINAL part348 Teh Seng Pharmaceutical Mfg. Co., Ltd. MENTHOL 5 g/100g 67542-010_31aef1dd-2dcc-42fc-b46b-c80a66bf8bbd 67542-010 HUMAN OTC DRUG BAUME PRODIGIEUX LEVRES 01 NATURAL CRYSTAL NUTRI-PROTECTING LIP CARE SPF 15 OCTINOXATE, AVOBENZONE LIPSTICK TOPICAL 20060501 OTC MONOGRAPH FINAL part352 LABORATOIRE NUXE AVOBENZONE; OCTINOXATE 2.9; 7.3 mL/100mL; mL/100mL 67542-020_7309b478-33c8-40f5-b1bb-90b6e38533b8 67542-020 HUMAN OTC DRUG BAUME PRODIGIEUX LEVRES 02 LEGENDAIRE PINK NUTRI-PROTECTING LIP CARE SPF 15 OCTINOXATE, AVOBENZONE LIPSTICK TOPICAL 20070501 OTC MONOGRAPH FINAL part352 LABORATOIRE NUXE AVOBENZONE; OCTINOXATE 2.9; 7.3 mL/100mL; mL/100mL 67542-030_4d11554a-6806-4a8c-a161-5c9cdd83cdfa 67542-030 HUMAN OTC DRUG BAUME PRODIGIEUX LEVRES 03 SHIMMERING CHOCOLATE NUTRI-PROTECTING LIP CARE SPF 15 OCTINOXATE, AVOBENZONE LIPSTICK TOPICAL 20070501 OTC MONOGRAPH FINAL part352 LABORATOIRE NUXE AVOBENZONE; OCTINOXATE 2.9; 7.3 mL/100mL; mL/100mL 67542-040_c449bdb6-5d09-4d64-81a4-edbef8b8feb3 67542-040 HUMAN OTC DRUG BAUME PRODIGIEUX LEVRES 04 RED CHARISMATIC NUTRI-PROTECTING LIP CARE SPF 15 OCTINOXATE, AVOBENZONE LIPSTICK TOPICAL 20090401 OTC MONOGRAPH FINAL part352 LABORATOIRE NUXE AVOBENZONE; OCTINOXATE 2.9; 7.3 mL/100mL; mL/100mL 67544-001_90f66ef7-4b4c-4386-a1fa-56d0cbc08d1e 67544-001 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 Aphena Pharma Solutions - Tennessee, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 67544-002_90f66ef7-4b4c-4386-a1fa-56d0cbc08d1e 67544-002 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 Aphena Pharma Solutions - Tennessee, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 67544-003_90f66ef7-4b4c-4386-a1fa-56d0cbc08d1e 67544-003 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 Aphena Pharma Solutions - Tennessee, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 67544-005_02a9e5f5-eeaf-49fa-b28d-1b1f560ea902 67544-005 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Aphena Pharma Solutions - Tennessee, LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-012_97a0746d-58ce-4eab-8a2e-231e6988448c 67544-012 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 Aphena Pharma Solutions - Tennessee, LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 67544-021_f2c3a3a3-2b0d-46eb-94fb-2b708690c0eb 67544-021 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 Aphena Pharma Solutions - Tennessee, LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 67544-023_5d9e47c2-cf3a-4def-a906-1d7fe00c6620 67544-023 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA089160 Aphena Pharma Solutions - Tennessee, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67544-024_5d9e47c2-cf3a-4def-a906-1d7fe00c6620 67544-024 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040201 Aphena Pharma Solutions - Tennessee, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67544-025_5d9e47c2-cf3a-4def-a906-1d7fe00c6620 67544-025 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040201 Aphena Pharma Solutions - Tennessee, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67544-026_5d9e47c2-cf3a-4def-a906-1d7fe00c6620 67544-026 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040084 Aphena Pharma Solutions - Tennessee, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67544-038_100df325-8fc5-4e54-95d9-19c8b1f81a13 67544-038 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19880112 ANDA ANDA071427 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-052_bc534aeb-3ada-4dc5-8d65-d7b321f4b500 67544-052 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 67544-057_31c3f6b2-2ac4-440f-90bc-15aae152d990 67544-057 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20030201 UNAPPROVED DRUG OTHER Aphena Pharma Solutions - Tennessee, Inc. PHENOBARBITAL 32.4 mg/1 CIV 67544-060_de793f36-7be2-4f3e-89d9-0db5067cf561 67544-060 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20000407 NDA NDA020702 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 67544-061_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-061 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 67544-070_bc534aeb-3ada-4dc5-8d65-d7b321f4b500 67544-070 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 67544-075_ca0bf468-958c-439f-9568-defb902354cf 67544-075 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 Aphena Pharma Solutions - Tennessee, LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 67544-078_31bfccac-afec-4ca6-aa1f-024e6e54aff3 67544-078 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950406 ANDA ANDA074132 Aphena Pharma Solutions - Tennessee, LLC NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 67544-080_bedd246d-d8fe-4d00-98bd-8042d81f964b 67544-080 HUMAN PRESCRIPTION DRUG Zoloft SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Aphena Pharma Solutions - Tennessee, LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67544-085_0c1f0c4b-ed50-47ad-94a6-98a47ead9315 67544-085 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aphena Pharma Solutions - Tennessee, LLC AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 67544-087_74ba9277-cf16-4079-ad5b-b444357bf663 67544-087 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073025 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67544-097_b9b84358-3975-4cee-a86f-7c61c2c0f55e 67544-097 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Aphena Pharma Solutions - Tennessee, LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 67544-102_cb3df109-9a12-43f9-b1dd-99e156d81b11 67544-102 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20110209 NDA NDA019129 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 67544-106_8eccf91e-8dd6-406a-bfe2-a45d49012d13 67544-106 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075636 Aphena Pharma Solutions - Tennessee, LLC LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 67544-117_e3c09b61-e055-476c-b814-9ef152507f28 67544-117 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE, GELATIN COATED ORAL 20070102 ANDA ANDA072251 Aphena Pharma Solutions - Tennessee, LLC OXAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-127_20ae218f-ccab-4c28-98c0-1a41b8e8f008 67544-127 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20121025 ANDA ANDA070920 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-136_349eedc7-991d-4012-9c58-0179f7350568 67544-136 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 19870803 ANDA ANDA071638 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-142_3437598f-3128-4bd3-a0e5-f55b485dee04 67544-142 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072928 Aphena Pharma Solutions - Tennessee, LLC LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-154_c3fb8c8c-fa8d-4890-a843-1999add4d22b 67544-154 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Aphena Pharma Solutions - Tennessee, LLC POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 67544-161_74ba9277-cf16-4079-ad5b-b444357bf663 67544-161 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 ANDA ANDA074052 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67544-185_28f2a162-654f-48d1-b0d8-41e06d8eca95 67544-185 HUMAN PRESCRIPTION DRUG Adalat CC nifedipine TABLET, FILM COATED ORAL 19930421 NDA NDA020198 Aphena Pharma Solutions - Tennessee, LLC NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 67544-189_d6e1473b-b1ff-4562-b1ab-65e820de2692 67544-189 HUMAN PRESCRIPTION DRUG Effexor XR Extended-Release venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Aphena Pharma Solutions - Tennessee, Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67544-191_3437598f-3128-4bd3-a0e5-f55b485dee04 67544-191 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072926 Aphena Pharma Solutions - Tennessee, LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-194_bc534aeb-3ada-4dc5-8d65-d7b321f4b500 67544-194 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 67544-195_bc534aeb-3ada-4dc5-8d65-d7b321f4b500 67544-195 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 67544-204_a427cdfd-7e1f-4f7c-ba6a-167e56d9d340 67544-204 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Aphena Pharma Solutions - Tennessee, LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67544-206_0c1f0c4b-ed50-47ad-94a6-98a47ead9315 67544-206 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aphena Pharma Solutions - Tennessee, LLC AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 67544-217_20ae218f-ccab-4c28-98c0-1a41b8e8f008 67544-217 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20121025 ANDA ANDA070920 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-224_4c645cf7-1073-45c1-a01f-537f067833f2 67544-224 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Aphena Pharma Solutions - Tennessee, LLC ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 67544-225_8eccf91e-8dd6-406a-bfe2-a45d49012d13 67544-225 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075636 Aphena Pharma Solutions - Tennessee, LLC LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 67544-236_74bda58d-0659-4d1d-b968-a2d3fbf6e50d 67544-236 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Aphena Pharma Solutions - Tennessee, LLC ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 67544-237_c3fb8c8c-fa8d-4890-a843-1999add4d22b 67544-237 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Aphena Pharma Solutions - Tennessee, LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 67544-245_8eccf91e-8dd6-406a-bfe2-a45d49012d13 67544-245 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075636 Aphena Pharma Solutions - Tennessee, LLC LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 67544-247_de793f36-7be2-4f3e-89d9-0db5067cf561 67544-247 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 67544-250_2c24af9b-48af-4f5b-b4e5-50e0f2f87ed7 67544-250 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20130122 ANDA ANDA076113 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 67544-251_a5cc3bc3-6e0e-4c01-b631-c927413f459b 67544-251 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19890503 ANDA ANDA071611 Aphena Pharma Solutions - Tennessee, LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 67544-252_a6d39b9c-024a-4c09-b0c3-263456317fb4 67544-252 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 19990610 ANDA ANDA075191 Aphena Pharma Solutions - Tennessee, LLC PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 67544-253_0c1f0c4b-ed50-47ad-94a6-98a47ead9315 67544-253 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aphena Pharma Solutions - Tennessee, LLC AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 67544-261_3437598f-3128-4bd3-a0e5-f55b485dee04 67544-261 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 Aphena Pharma Solutions - Tennessee, LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-268_e3c09b61-e055-476c-b814-9ef152507f28 67544-268 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE, GELATIN COATED ORAL 20070102 ANDA ANDA072252 Aphena Pharma Solutions - Tennessee, LLC OXAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-273_dd9b82e8-41a2-469e-b6fb-2332a1a38912 67544-273 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 Aphena Pharma Solutions - Tennessee, LLC DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 67544-276_8630b890-129e-4ef3-b8cb-afc47305a71e 67544-276 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 67544-287_349eedc7-991d-4012-9c58-0179f7350568 67544-287 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 19870803 ANDA ANDA071638 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-289_23891fcd-df44-428d-b328-335ca1b7c777 67544-289 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 Aphena Pharma Solutions - Tennessee, LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-290_02a9e5f5-eeaf-49fa-b28d-1b1f560ea902 67544-290 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Aphena Pharma Solutions - Tennessee, LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-298_bedd246d-d8fe-4d00-98bd-8042d81f964b 67544-298 HUMAN PRESCRIPTION DRUG Zoloft SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Aphena Pharma Solutions - Tennessee, LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67544-301_23891fcd-df44-428d-b328-335ca1b7c777 67544-301 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 Aphena Pharma Solutions - Tennessee, LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-302_b9b84358-3975-4cee-a86f-7c61c2c0f55e 67544-302 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Aphena Pharma Solutions - Tennessee, LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 67544-306_1e4cd5c0-6b72-4fae-a4c7-95f8ef34cc87 67544-306 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040423 ANDA ANDA076483 Aphena Pharma Solutions - Tennessee, Inc. FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 67544-318_7092a87a-54fb-4f82-8f58-0a950bf0db3d 67544-318 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 67544-322_1e4cd5c0-6b72-4fae-a4c7-95f8ef34cc87 67544-322 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040423 ANDA ANDA076483 Aphena Pharma Solutions - Tennessee, Inc. FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 67544-326_045a1d78-1ac0-4f65-958e-8777ab4b1cf2 67544-326 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950222 ANDA ANDA074056 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67544-332_74ba9277-cf16-4079-ad5b-b444357bf663 67544-332 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073026 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67544-338_5d3ad7cd-d844-49b9-adde-a05f12d0ea8a 67544-338 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 67544-346_5d3ad7cd-d844-49b9-adde-a05f12d0ea8a 67544-346 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 67544-349_feae1673-5b26-40a2-9127-24426383a86b 67544-349 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 Aphena Pharma Solutions - Tennessee, Inc. POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 67544-353_03cba200-f94b-4357-bee2-b32b12f19891 67544-353 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67544-354_03cba200-f94b-4357-bee2-b32b12f19891 67544-354 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67544-355_adc5a44a-091a-4541-95af-9e3ec75f0eef 67544-355 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Aphena Pharma Solutions - Tennessee, LLC SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 67544-356_adc5a44a-091a-4541-95af-9e3ec75f0eef 67544-356 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Aphena Pharma Solutions - Tennessee, LLC SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 67544-361_03cba200-f94b-4357-bee2-b32b12f19891 67544-361 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67544-371_64ebbee6-7e2a-455f-9f96-92bc25d3e691 67544-371 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Aphena Pharma Solutions - Tennessee, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 67544-373_100df325-8fc5-4e54-95d9-19c8b1f81a13 67544-373 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19880112 ANDA ANDA071428 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-394_68d8e3a9-cabb-46aa-b327-9d024d41a6e7 67544-394 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030827 ANDA ANDA040511 Aphena Pharma Solutions - Tennessee, LLC ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 67544-401_bc534aeb-3ada-4dc5-8d65-d7b321f4b500 67544-401 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 67544-403_948ffea7-be2c-4b21-9880-8e27af9a4090 67544-403 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Aphena Pharma Solutions - Tennessee, LLC VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 67544-404_948ffea7-be2c-4b21-9880-8e27af9a4090 67544-404 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Aphena Pharma Solutions - Tennessee, LLC VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 67544-408_cb3df109-9a12-43f9-b1dd-99e156d81b11 67544-408 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20110209 NDA NDA019129 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 67544-412_23891fcd-df44-428d-b328-335ca1b7c777 67544-412 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 Aphena Pharma Solutions - Tennessee, LLC CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-431_da02b76d-00ea-4733-aef8-7808b0b45d47 67544-431 HUMAN PRESCRIPTION DRUG Fosinopril sodium Fosinopril sodium TABLET ORAL 20050621 ANDA ANDA077222 Aphena Pharma Solutions - Tennessee, LLC FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 67544-456_81d7938c-6dd1-4368-a5fc-0b7b6c2b2ded 67544-456 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Aphena Pharma Solutions - Tennessee, LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67544-464_75f35191-7de2-4503-a06e-134999aa98b9 67544-464 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20031125 ANDA ANDA075932 Aphena Pharma Solutions - Tennessee, LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 67544-468_c6cea106-a61e-4ee6-9961-c0e89109c372 67544-468 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH FINAL part343 Aphena Pharma Solutions - Tennessee, LLC ASPIRIN 325 mg/1 67544-474_6d0a1553-38cf-41c5-a7a4-1d738112d94c 67544-474 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089828 Aphena Pharma Solutions - Tennessee, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 67544-475_81d7938c-6dd1-4368-a5fc-0b7b6c2b2ded 67544-475 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Aphena Pharma Solutions - Tennessee, LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67544-479_4c40fbad-f018-45a5-813f-5a7dca18c9a6 67544-479 HUMAN PRESCRIPTION DRUG Valproic Acid valproic acid CAPSULE ORAL 19911029 ANDA ANDA073229 Aphena Pharma Solutions - Tennessee, LLC VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 67544-507_2f463f71-cfb1-4db3-a004-02b88ceae1ad 67544-507 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20080515 NDA NDA021400 APHENA PHARMA SOLUTIONS - TENNESSEE, INC. VARDENAFIL HYDROCHLORIDE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 67544-510_6651d00a-865c-49c9-aa6f-b67b20893c1c 67544-510 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20021104 ANDA ANDA075410 Aphena Pharma Solutions - Tennessee, LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 67544-511_4cb7dc91-6c9a-4feb-b2aa-7b4724e9f681 67544-511 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET ORAL 20050628 ANDA ANDA076716 Aphena Pharma Solutions - Tennessee, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 67544-512_2f463f71-cfb1-4db3-a004-02b88ceae1ad 67544-512 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20080515 NDA NDA021400 APHENA PHARMA SOLUTIONS - TENNESSEE, INC. VARDENAFIL HYDROCHLORIDE 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 67544-524_4022ec92-1e3c-40a7-9a23-e28f40e79a12 67544-524 HUMAN OTC DRUG Aspirin EC Aspirin TABLET, COATED ORAL 19940205 OTC MONOGRAPH FINAL part343 Aphena Pharma Solutions - Tennessee, LLC ASPIRIN 81 mg/1 67544-534_4638c35e-72ef-4f22-832c-de21700093dc 67544-534 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19801126 NDA NDA017812 Aphena Pharma Solutions - Tennessee, Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 67544-562_e880cdbb-908e-45e2-83c7-0742a66a1ef0 67544-562 HUMAN PRESCRIPTION DRUG Terazosin hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Aphena Pharma Solutions - Tennessee, LLC TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 67544-563_e880cdbb-908e-45e2-83c7-0742a66a1ef0 67544-563 HUMAN PRESCRIPTION DRUG Terazosin hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Aphena Pharma Solutions - Tennessee, LLC TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 67544-564_e880cdbb-908e-45e2-83c7-0742a66a1ef0 67544-564 HUMAN PRESCRIPTION DRUG Terazosin hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20041221 ANDA ANDA075317 Aphena Pharma Solutions - Tennessee, LLC TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 67544-567_f3bcf3f8-72ce-4359-877e-13cef7ecf1c1 67544-567 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130422 ANDA ANDA076704 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67544-568_7a2b5130-7c3c-4407-94dc-085e4e3652d1 67544-568 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19910313 ANDA ANDA070086 Aphena Pharma Solutions - Tennessee, LLC FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 67544-570_37fa075f-798b-4335-8f5f-d76d513acdd8 67544-570 HUMAN PRESCRIPTION DRUG Pacerone Amiodarone Hydrochloride TABLET ORAL 20110119 ANDA ANDA075135 Aphena Pharma Solutions - Tennessee, LLC AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 67544-581_e880cdbb-908e-45e2-83c7-0742a66a1ef0 67544-581 HUMAN PRESCRIPTION DRUG Terazosin hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Aphena Pharma Solutions - Tennessee, LLC TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 67544-627_f3bcf3f8-72ce-4359-877e-13cef7ecf1c1 67544-627 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130422 ANDA ANDA076704 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67544-629_02a9e5f5-eeaf-49fa-b28d-1b1f560ea902 67544-629 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Aphena Pharma Solutions - Tennessee, LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-655_88c9255c-f367-4bfa-9179-15d0ac6d326a 67544-655 HUMAN OTC DRUG Bisacodyl Enteric Coated Bisacodyl TABLET, COATED ORAL 20081024 OTC MONOGRAPH NOT FINAL part334 Aphena Pharma Solutions - Tennessee, LLC BISACODYL 5 mg/1 67544-656_7bba784e-b2dd-4662-a66d-09246be23c7c 67544-656 HUMAN PRESCRIPTION DRUG Renagel Renagel TABLET ORAL 20080606 NDA NDA021179 Aphena Pharma Solutions - Tennessee, LLC SEVELAMER HYDROCHLORIDE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 67544-662_12218dbe-1891-4491-b98c-caf6750ae792 67544-662 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Aphena Pharma Solutions - Tennessee, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 67544-670_5d9e47c2-cf3a-4def-a906-1d7fe00c6620 67544-670 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040400 Aphena Pharma Solutions - Tennessee, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 67544-679_81d7938c-6dd1-4368-a5fc-0b7b6c2b2ded 67544-679 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Aphena Pharma Solutions - Tennessee, LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67544-697_37c91b72-c47b-4200-a66a-2f3a24de2e43 67544-697 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Aphena Pharma Solutions - Tennessee, LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-700_b13be519-3c63-40cb-a3ee-66ec6238310f 67544-700 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 20121012 ANDA ANDA072741 Aphena Pharma Solutions - Tennessee, LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 67544-720_d6b6a9b8-aa6a-4b5d-b5ce-564b858d67e9 67544-720 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Aphena Pharma Solutions - Tennessee, LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-725_7db1e55e-aa96-49a3-b21e-62e198e1877a 67544-725 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 19940601 ANDA ANDA074224 Aphena Pharma Solutions - Tennessee, Inc. TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-747_12218dbe-1891-4491-b98c-caf6750ae792 67544-747 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Aphena Pharma Solutions - Tennessee, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 67544-807_b6848545-e2e1-40d1-aa7e-e5f6100b9edd 67544-807 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 19940126 ANDA ANDA074131 Aphena Pharma Solutions - Tennessee, LLC PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67544-840_f4f39613-d1df-48ec-9b69-2ec30b4a5dc4 67544-840 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Aphena Pharma Solutions - Tennessee, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67544-848_b6d3beec-9ded-46ae-9122-462504bf2741 67544-848 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20020129 ANDA ANDA075049 Aphena Pharma Solutions - Tennessee, LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 67544-870_dc10ad3e-db44-4346-8945-fe25b0999f9f 67544-870 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20130305 ANDA ANDA077657 Aphena Pharma Solutions - Tennessee, LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-879_dc10ad3e-db44-4346-8945-fe25b0999f9f 67544-879 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20130305 ANDA ANDA077657 Aphena Pharma Solutions - Tennessee, LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-882_6d0a1553-38cf-41c5-a7a4-1d738112d94c 67544-882 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 Aphena Pharma Solutions - Tennessee, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 67544-883_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-883 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 67544-884_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-884 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 67544-885_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-885 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 67544-886_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-886 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 67544-887_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-887 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 67544-888_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-888 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 67544-889_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-889 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 67544-890_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-890 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020224 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 67544-891_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-891 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 67544-892_4656613f-ab12-4d5f-a7ad-573b6f0e2e3a 67544-892 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Aphena Pharma Solutions - Tennessee, LLC BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 67544-899_f4f39613-d1df-48ec-9b69-2ec30b4a5dc4 67544-899 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Aphena Pharma Solutions - Tennessee, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67544-911_f3bcf3f8-72ce-4359-877e-13cef7ecf1c1 67544-911 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130422 ANDA ANDA076704 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67544-946_4638c35e-72ef-4f22-832c-de21700093dc 67544-946 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19870128 NDA NDA017812 Aphena Pharma Solutions - Tennessee, Inc. LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] 67544-982_dc10ad3e-db44-4346-8945-fe25b0999f9f 67544-982 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20130305 ANDA ANDA077657 Aphena Pharma Solutions - Tennessee, LLC LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67544-988_64ebbee6-7e2a-455f-9f96-92bc25d3e691 67544-988 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Aphena Pharma Solutions - Tennessee, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 67546-111_51903bf9-4f7c-4150-b9b2-ee504272e324 67546-111 HUMAN PRESCRIPTION DRUG Alinia nitazoxanide TABLET ORAL 20040721 NDA NDA021497 Romark Laboratories, LC NITAZOXANIDE 500 mg/1 Antiprotozoal [EPC] 67546-212_51903bf9-4f7c-4150-b9b2-ee504272e324 67546-212 HUMAN PRESCRIPTION DRUG Alinia nitazoxanide POWDER, FOR SUSPENSION ORAL 20021122 NDA NDA021498 Romark Laboratories, LC NITAZOXANIDE 100 mg/5mL Antiprotozoal [EPC] 67555-140_a769b672-5a74-4d2a-a01a-e7c3c124d94e 67555-140 HUMAN PRESCRIPTION DRUG MaxFe ascorbic acid, folic acid, vitamin b-12, biotin, iron, magnesium, zinc TABLET ORAL 20140601 UNAPPROVED DRUG OTHER Pronova Corporation ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DOCUSATE SODIUM; FOLIC ACID; IRON; MAGNESIUM; ZINC 100; 150; 60; 50; 1; 160; 6.5; 12 mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 67555-153_b2ade83e-2dee-43e2-be8f-2e0a39057bba 67555-153 HUMAN PRESCRIPTION DRUG Folet DHA DHA (docosahexaenoic acid), Vit.A (beta-carotine), Vit.C (ascorbic acid), Vit.D-3 (cholecalciferol), Vit.E (d-alpha-tocopheryl acetate), Vit.B-1 (thiamine HCl), Vit.B-2 (riboflavin), Vit.B-3 (niacinamide), Vit.B-6 (pyridoxine HCl), Folate (1.85 mg (6S)-5-methyltetrahydrofolate-Quatrefolic), Vit.B-12 (cyanocobalamin), Iron (carbonyl iron -Ferronyl and ferrous bis-glycinate chelate -Ferrochel), Magnesium (magnesium oxide), Zinc (zinc bis-glycinate chelate -TRAACS), Selenium (sodium selenate), Docusate Sodium KIT 20140828 UNAPPROVED DRUG OTHER Pronova Corporation 67555-154_fb5ae915-5d9b-49ef-b9bf-e6c3198681fb 67555-154 HUMAN PRESCRIPTION DRUG Folet One Vitamin C, Vitamin D, Vitamine E, Vitamine B6, Folate, Vitamine B12, Iron, Zinc, Magnesium, Docusate Sodium, DHA CAPSULE, LIQUID FILLED ORAL 20140601 UNAPPROVED DRUG OTHER Pronova Corporation .ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON; MAGNESIUM; PYRIDOXINE HYDROCHLORIDE; ZINC 15; 18; 250; 15; 225; 25; 1; 38; 15; 30; 20 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 67567-0306_ccd725b8-1d98-4864-9429-b27d8498e7fe 67567-0306 HUMAN OTC DRUG HeadOn Ultimate Relief Iris Versicolor Root and Bryonia Alba Root STICK TOPICAL 20100601 UNAPPROVED HOMEOPATHIC American Health Distributions Inc. BRYONIA ALBA ROOT; IRIS VERSICOLOR ROOT 12; 12 [hp_X]/1; [hp_X]/1 67573-0101_bfadc1ca-4577-4a92-97b8-c4c71ac14002 67573-0101 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19770101 UNAPPROVED MEDICAL GAS B&J Welding Supply LTD OXYGEN 99.5 L/100L 67587-001_1d3b0ea6-b2b8-43df-b001-ece1677f6f89 67587-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19840101 UNAPPROVED MEDICAL GAS Allina Home Oxygen and Medical Equipment OXYGEN 99 L/100L 67596-001_d7239550-acf2-48fc-a3a5-f6c7907f5711 67596-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20011101 UNAPPROVED MEDICAL GAS Compressed Gas Solutions Inc OXYGEN 995 mL/L 67603-001_0f064971-97de-42c3-a733-4c8e86f022ab 67603-001 HUMAN OTC DRUG Cellex-C Sun Care Octinoxate 7.5%, Octisalate 5.0% Titanium Dioxide 3.0%, Zinc Oxide 7.0% CREAM TOPICAL 20140630 OTC MONOGRAPH FINAL part352 Cellex-C International Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 3; 7 mg/100mL; mg/100mL; mg/100mL; mg/100mL 67603-002_37f113a2-db7b-4ca3-aaf8-58eab12686ad 67603-002 HUMAN OTC DRUG Cellex-C Sun Shade Octinoxate 7.5%, Octisalate 5.0% Titanium Dioxide 3.0%, Zinc Oxide 7.0% CREAM TOPICAL 20140630 OTC MONOGRAPH FINAL part352 Cellex-C International Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 3; 7 mg/100mL; mg/100mL; mg/100mL; mg/100mL 67618-100_72533570-14da-f3c0-9873-a8d87ba759cd 67618-100 HUMAN OTC DRUG Colace Docusate sodium CAPSULE ORAL 19970130 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP DOCUSATE SODIUM 50 mg/1 67618-101_72533570-14da-f3c0-9873-a8d87ba759cd 67618-101 HUMAN OTC DRUG Colace Docusate sodium CAPSULE ORAL 19970130 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP DOCUSATE SODIUM 100 mg/1 67618-106_f63ecf22-fb2b-8677-5bfe-c6ac368977a3 67618-106 HUMAN OTC DRUG Peri-Colace Docusate sodium - sennosides TABLET, FILM COATED ORAL 19570208 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 67618-148_2f07daa4-86ee-4a2d-ae3a-c3a7b574ed10 67618-148 HUMAN OTC DRUG Betadine POVIDONE-IODINE SPRAY TOPICAL 19920415 OTC MONOGRAPH NOT FINAL part333A Purdue Products LP POVIDONE-IODINE .05 mL/mL 67618-149_5a71a971-4397-4bde-b14f-47adc2785ca2 67618-149 HUMAN OTC DRUG Betadine Skin Cleanser POVIDONE-IODINE SOLUTION TOPICAL 19730715 OTC MONOGRAPH NOT FINAL part333A Purdue Products LP POVIDONE-IODINE .075 mL/mL 67618-150_41891599-420e-48d2-8e31-d28a2209e383 67618-150 HUMAN OTC DRUG Betadine POVIDONE-IODINE SOLUTION TOPICAL 19960715 OTC MONOGRAPH NOT FINAL part333A Purdue Products LP POVIDONE-IODINE .01 mL/mL 67618-151_1ad39e11-ea1e-44a4-8224-93f8135436c2 67618-151 HUMAN OTC DRUG Betadine Surgical Scrub POVIDONE-IODINE SOLUTION TOPICAL 19800615 OTC MONOGRAPH NOT FINAL part333A Purdue Products LP POVIDONE-IODINE .075 mL/mL 67618-152_d032d0f7-3cdc-29d9-7320-188113b08e30 67618-152 HUMAN OTC DRUG Betadine POVIDONE-IODINE SWAB TOPICAL 19920401 OTC MONOGRAPH NOT FINAL part333A Purdue Products LP POVIDONE-IODINE 100 mg/mL 67618-153_0707b259-52a4-4ae6-b176-d093865906e7 67618-153 HUMAN OTC DRUG Betadine Solution Swabsticks POVIDONE-IODINE SWAB TOPICAL 19720915 OTC MONOGRAPH NOT FINAL part333A Purdue Products LP POVIDONE-IODINE .01 mL/1 67618-200_c1883003-f8e9-438e-93aa-27a95a2a90a4 67618-200 HUMAN PRESCRIPTION DRUG BETASEPT Antiseptic Surgical Scrub SOLUTION TOPICAL 19930601 NDA NDA019125 Purdue Products LP CHLORHEXIDINE GLUCONATE .04 mg/mL Decreased Cell Wall Integrity [PE] 67618-300_73128a8a-bc7a-4e34-a211-0adaf7628ff6 67618-300 HUMAN OTC DRUG Senokot standardized senna concentrate TABLET ORAL 19560601 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP SENNOSIDES 8.6 mg/1 67618-310_7ff38123-df25-8403-c30f-0084ea8f78ec 67618-310 HUMAN OTC DRUG Senokot-S standardized senna concentrate and docusate sodium TABLET ORAL 19741001 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 67618-315_08e1a2f2-be14-95ba-f1ae-f7744e8af835 67618-315 HUMAN OTC DRUG SenokotXTRA standardized senna concentrate TABLET ORAL 19880901 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP SENNOSIDES 17.2 mg/1 67659-041_3c62d647-d17e-4da8-a141-48dc6bff4242 67659-041 HUMAN OTC DRUG Laura Lynn Anticavity Sodium Fluoride PASTE DENTAL 20060829 OTC MONOGRAPH FINAL part355 Team Technologies, Inc SODIUM FLUORIDE 2.43 mg/g 67659-062_57b1a2f3-8c90-4b32-8533-894237cf293d 67659-062 HUMAN OTC DRUG Walgreens Anticavity and Antigingivits Whitening Fluoride Toothpaste Anticavity and Antigingivitis Whitening Fluoride PASTE, DENTIFRICE DENTAL 20081124 UNAPPROVED OTHER Team Technologies, Inc SODIUM FLUORIDE 2.43 mg/g 67659-078_f4b1f6e9-1f51-4204-a2d0-bbcf28baa62c 67659-078 HUMAN OTC DRUG Up and Up Sensitive Toothpaste Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20100825 OTC MONOGRAPH NOT FINAL part356 Team Technologies, Inc POTASSIUM NITRATE; SODIUM FLUORIDE 5; 2.43 mg/g; mg/g 67659-079_18708150-8558-400f-84b2-62ea4a8ddc0e 67659-079 HUMAN OTC DRUG Up and Up Sensitive Toothpaste Whitening Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20100825 OTC MONOGRAPH NOT FINAL part356 Team Technologies, Inc POTASSIUM NITRATE; SODIUM FLUORIDE 5; 2.43 mg/g; mg/g 67659-080_a82a82ab-ee33-4a07-8a3b-354c1394fd96 67659-080 HUMAN OTC DRUG Up and UP Sensitive Toothpaste Enamel Strengthening formula Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20100825 OTC MONOGRAPH NOT FINAL part356 Team Technologies, Inc POTASSIUM NITRATE; SODIUM FLUORIDE 5; 1.5 mg/g; mg/g 67659-081_0b63aecc-599e-4662-a77e-e2a0a47bb051 67659-081 HUMAN OTC DRUG Up and UP Sensitive Toothpaste Enamel Strengthening formula plus whitening Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20100825 OTC MONOGRAPH NOT FINAL part356 Team Technologies, Inc POTASSIUM NITRATE; SODIUM FLUORIDE 5; 1.5 mg/g; mg/g 67659-082_a4b74051-aca6-4926-a464-41bf4539d968 67659-082 HUMAN OTC DRUG Up and Up Anticavity Toothpaste Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100825 OTC MONOGRAPH FINAL part355 Team Technologies, Inc SODIUM FLUORIDE 2.43 mg/g 67659-083_b0b132a3-c7b9-4996-b326-36b7fe1c0167 67659-083 HUMAN OTC DRUG Up and Up Anticavity Toothpaste Multi Function Stannous Fluoride PASTE, DENTIFRICE DENTAL 20100825 OTC MONOGRAPH FINAL part355 Team Technologies, Inc STANNOUS FLUORIDE 4.54 mg/g 67659-084_586b4bf2-5c80-40b8-bcad-44d678a6d40c 67659-084 HUMAN OTC DRUG Up and UP Anticavity Toothpaste Whitening Plus Mouthwash Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100825 OTC MONOGRAPH FINAL part355 Team Technologies, Inc SODIUM FLUORIDE 2.43 mg/g 67659-085_33e7c7b7-299b-42c2-86e4-fcc30dbeb8b1 67659-085 HUMAN OTC DRUG Walgreens Scooby Doo Fluoride Gel Toothpaste Sodium Fluoride PASTE DENTAL 20100802 OTC MONOGRAPH FINAL part355 Team Technologies, Inc SODIUM FLUORIDE 2.4 mg/g 67662-001_286fff75-296a-4268-be96-5b63a797ee41 67662-001 HUMAN OTC DRUG Mediflex Menthol CREAM TOPICAL 20100329 OTC MONOGRAPH NOT FINAL part348 SAS Group Inc. MENTHOL 5 1/85g 67668-161_89050554-8e16-41ce-88a5-30718b7f6f9c 67668-161 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Unique Pharmaceutical Laboratories CETIRIZINE HYDROCHLORIDE 5 mg/1 67668-162_ba27b932-bae3-41d2-bfe4-017c4f036670 67668-162 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Unique Pharmaceutical Laboratories CETIRIZINE HYDROCHLORIDE 10 mg/1 67676-002_01375d99-2cf8-4315-b23c-ed78c9a14c73 67676-002 HUMAN OTC DRUG Joint Formula 88 MAX PLUS CAMPHOR CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part341 Sarati International, Inc. CAMPHOR (SYNTHETIC) 3.18 g/100g 67676-101_7d6ec75d-9f3f-488e-abad-fdd33a33a8f8 67676-101 HUMAN OTC DRUG OsmoFlex Menthol CREAM TOPICAL 19930101 OTC MONOGRAPH FINAL part341 Sarati International, Inc. MENTHOL 1.3 g/100g 67684-1000_70b15a48-02f0-4066-b6a1-ea057e5ad710 67684-1000 HUMAN PRESCRIPTION DRUG Oxilan Ioxilan Injection INJECTION, SOLUTION INTRAVASCULAR 20020318 NDA NDA020316 Guerbet LLC IOXILAN 300 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 67684-1001_70b15a48-02f0-4066-b6a1-ea057e5ad710 67684-1001 HUMAN PRESCRIPTION DRUG Oxilan Ioxilan Injection INJECTION, SOLUTION INTRAVASCULAR 20020318 NDA NDA020316 Guerbet LLC IOXILAN 350 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 67684-1901_777709cc-dfe7-40a4-abbf-98f7a10cb0fc 67684-1901 HUMAN PRESCRIPTION DRUG LIPIODOL ethiodized oil INJECTION INTRA-ARTERIAL; INTRALYMPHATIC; INTRAUTERINE 20140321 NDA NDA009190 Guerbet LLC ETHIODIZED OIL 480 mg/mL 67684-2000_105319ef-8135-4ffb-b551-6c46b1fea6a3 67684-2000 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20130426 NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] 67684-2000_712e7ffc-134e-41f1-bfe5-b9252d3d48ac 67684-2000 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20130320 NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] 67684-5505_0133b6a1-075a-495d-ae44-ef936a0da170 67684-5505 HUMAN PRESCRIPTION DRUG HEXABRIX ioxaglate meglumine and ioxaglate sodium INJECTION INTRAVASCULAR 20090409 NDA NDA018905 Guerbet LLC IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM 393; 196 mg/mL; mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 67691-100_7a8c3b04-8b4b-45f4-9595-911fb70c1c9b 67691-100 HUMAN OTC DRUG Plum Emergency Eyewash Water LIQUID OPHTHALMIC 20080208 OTC MONOGRAPH NOT FINAL part349 Bel-Art Products WATER 99.1 mL/100mL 67691-101_70bfa882-16fa-41aa-9eae-b7e0b366f756 67691-101 HUMAN OTC DRUG Plum Duo Emergency Eyewash Water LIQUID OPHTHALMIC 20100623 OTC MONOGRAPH NOT FINAL part349 Bel-Art Products WATER 99.1 mL/100mL 67691-200_89d4dd83-4cd0-408d-aa0a-827a98d7ab83 67691-200 HUMAN OTC DRUG Plum Emergency Eyewash pH Neutralizing Water LIQUID OPHTHALMIC 20080601 OTC MONOGRAPH NOT FINAL part349 Bel-Art Products WATER 95.1 mL/100mL 67691-201_f243741a-8189-4359-8a8a-29d1bd166c86 67691-201 HUMAN OTC DRUG Plum Duo Emergency Eyewash pH Neutralizing Water LIQUID OPHTHALMIC 20100623 OTC MONOGRAPH NOT FINAL part349 Bel-Art Products WATER 95.1 mL/100mL 67691-769_28332612-0bd9-4a45-88fa-0ee7bdeb7393 67691-769 HUMAN OTC DRUG Scienceware Eyewash Water SOLUTION OPHTHALMIC 19940101 OTC MONOGRAPH FINAL part349 Bel-Art Products WATER 98.5 mL/100mL 67692-000_ed5bd9f4-c3e4-4e26-8e1f-f43bab6a90a5 67692-000 HUMAN OTC DRUG Lumene Vitamin C BB Illuminating Anti-Age BB Sunscreen Broad Spectrum SPF 20 Medium OCTINOXATE CREAM TOPICAL 20120808 OTC MONOGRAPH FINAL part352 Lumene Oy OCTINOXATE 6 mL/100mL 67692-001_05205467-bd3d-49d1-a1b6-6c8012743136 67692-001 HUMAN OTC DRUG Lumene Vitamin C BB Illuminating Anti-Age BB Sunscreen Broad Spectrum SPF 20 Light OCTINOXATE CREAM TOPICAL 20120808 OTC MONOGRAPH FINAL part352 Lumene Oy OCTINOXATE 6 mL/100mL 67692-072_6caaa39f-b303-48b9-8506-bf589649e12b 67692-072 HUMAN OTC DRUG Lumene Excellent Future Age-Defying and Repairing Day SPF 15 Sunscreen AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20120912 OTC MONOGRAPH FINAL part352 LUMENE OY AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 6; 2; 2.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 67692-081_16f5bbe8-68fc-4aae-ae26-36653d579c01 67692-081 HUMAN OTC DRUG Lumene Vitamin C Pure Radiance Day AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20101122 OTC MONOGRAPH NOT FINAL part352 LUMENE OY AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 4; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 67692-141_fa986ca9-27a7-4edd-9c4d-5b121404cdef 67692-141 HUMAN OTC DRUG Lumene Bright Now Vitamin C Day SPF 15 Sunscreen Broad Spectrum OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20130904 OTC MONOGRAPH NOT FINAL part352 LUMENE OY AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL 67692-148_f910813c-d297-4c7c-8ef9-6f8b3edd20b7 67692-148 HUMAN OTC DRUG Lumene Bright Now Vitamin C BB SPF 20 Sunscreen Broad Spectrum 01 Light OCTINOXATE CREAM TOPICAL 20130904 OTC MONOGRAPH NOT FINAL part352 LUMENE OY OCTINOXATE 60 mg/mL 67692-149_cac30152-ef63-46de-87c2-6bba125c77a1 67692-149 HUMAN OTC DRUG Lumene Bright Now Vitamin C BB SPF 20 Sunscreen Broad Spectrum 02 Medium OCTINOXATE CREAM TOPICAL 20130904 OTC MONOGRAPH NOT FINAL part352 LUMENE OY OCTINOXATE 60 mg/mL 67692-241_8fb3cfee-5924-409e-bf46-646a89bf518b 67692-241 HUMAN OTC DRUG LUMENE Sensitive Touch Daily Moisture SPF 15 Sunscreen AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20121129 OTC MONOGRAPH NOT FINAL part352 LUMENE OY AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 70; 20; 27 mg/mL; mg/mL; mg/mL; mg/mL 67692-290_f8c559b4-f78b-47d9-bdc9-86825d436b1c 67692-290 HUMAN OTC DRUG Lumene Bright Now Visible Repair Day SPF 15 Sunscreen Broad Spectrum AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20140514 OTC MONOGRAPH NOT FINAL part352 LUMENE OY AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 60; 20; 27.5 mg/mL; mg/mL; mg/mL; mg/mL 67692-332_e24a000e-e2fa-4f76-ab9a-34cd42e8ebb2 67692-332 HUMAN OTC DRUG Lumene Time Freeze Firming Day SPF 15 Sunscreen Broad Spectrum AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20130904 OTC MONOGRAPH NOT FINAL part352 LUMENE OY AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 60; 20; 27 mg/mL; mg/mL; mg/mL; mg/mL 67692-339_720e594c-95a5-4d89-8cd0-70534fe577ff 67692-339 HUMAN OTC DRUG Lumene Time Freeze Targeted Dark Spot Corrector Sunscreen SPF 30 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20130821 OTC MONOGRAPH NOT FINAL part352 LUMENE OY OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 75; 60; 70 mg/mL; mg/mL; mg/mL 67692-340_08c42984-cc37-498c-807b-80b15c18af2e 67692-340 HUMAN OTC DRUG LUMENE TIME FREEZE FIRMING DAY SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20131107 OTC MONOGRAPH NOT FINAL part352 LUMENE OY AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 60; 20; 27 mg/mL; mg/mL; mg/mL; mg/mL 67692-361_0f970676-bb93-4d72-a505-b17e1c3389c1 67692-361 HUMAN OTC DRUG LUMENE TIME FREEZE FIRMING DAY SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20101119 OTC MONOGRAPH NOT FINAL part352 LUMENE OY AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL 67692-470_3e29e49e-4993-4909-8a1e-fc696c575f8a 67692-470 HUMAN OTC DRUG Lumene Complete Rewind Recovery Day SPF 15 Sunscreen Broad Spectrum AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20130411 OTC MONOGRAPH NOT FINAL part352 LUMENE OY AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 60; 20; 27 mg/mL; mg/mL; mg/mL; mg/mL 67692-500_c0bd36e4-76e3-43ce-93e7-11d5de84447e 67692-500 HUMAN OTC DRUG LUMENE PREMIUM BEAUTY REJUVENATING DAY AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20101119 OTC MONOGRAPH NOT FINAL part352 LUMENE OY AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 4; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 67692-810_9f3df133-6972-4e67-853f-6c75c396a902 67692-810 HUMAN OTC DRUG Lumene Time Freeze Anti-Age CC Color Correcting SPF 20 Sunscreen Broad Spectrum LIGHT OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20130409 OTC MONOGRAPH NOT FINAL part352 LUMENE OY OCTINOXATE; TITANIUM DIOXIDE 40; 8.3 mg/mL; mg/mL 67692-811_7e7d7996-7d03-43ff-9262-8705732621a8 67692-811 HUMAN OTC DRUG Lumene Time Freeze Anti-Age CC Color Correcting SPF 20 Sunscreen Broad Spectrum MEDIUM OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20130409 OTC MONOGRAPH NOT FINAL part352 LUMENE OY OCTINOXATE; TITANIUM DIOXIDE 40; 8.3 mg/mL; mg/mL 67711-001_4c90f372-42df-4146-a11a-55c41da7acda 67711-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20030101 UNAPPROVED MEDICAL GAS AIRSERVE, LLC OXYGEN 991 mL/L 67718-893_af74aa01-7237-4b4b-a512-b9420f63fe9c 67718-893 HUMAN OTC DRUG Garnier Fructis Antidandruff Mint Cleanse Pyrithione Zinc SHAMPOO TOPICAL 20110301 OTC MONOGRAPH FINAL part358H L'Oreal USA Florence Manufacturing PYRITHIONE ZINC 3.84 mL/384mL 67718-938_8eb943db-d446-4184-a34c-d7deb18d7875 67718-938 HUMAN OTC DRUG Garnier Fructis Antidandruff Clean and Fresh Pyrithione Zinc SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358 L'Oreal USA Florence Manufacturing PYRITHIONE ZINC 3.84 mL/384mL 67718-939_81e5565c-bdd2-42f6-8019-21ffe5ef2eec 67718-939 HUMAN OTC DRUG Garnier Fructis Antidandruff Clean and Fresh 2 in 1 Pyrithione Zinc SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358 L'Oreal USA Florence Manufacturing PYRITHIONE ZINC 3.84 mL/384mL 67718-941_bfc8e562-ca15-4e10-8668-83125f6f65e4 67718-941 HUMAN OTC DRUG Garnier Fructis Antidandruff Clean and Fresh 2 in 1 Pyrithione Zinc SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358 L'Oreal USA Florence Manufacturing PYRITHIONE ZINC 7.5 mL/750mL 67718-942_83185022-b482-423e-9f42-cbcd15b45d09 67718-942 HUMAN OTC DRUG Garnier Fructis Antidandruff Dry Scalp Pyrithione Zinc SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358 L'Oreal USA Florence Manufacturing PYRITHIONE ZINC 3.84 mL/384mL 67718-943_2c2ef2f5-1f11-4ce7-b3aa-e4563b376baf 67718-943 HUMAN OTC DRUG Garnier Fructis Antidandruff Dry Scalp Pyrithione Zinc SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358 L'Oreal USA Florence Manufacturing PYRITHIONE ZINC 7.5 mL/750mL 67718-948_9694c39c-693e-46f8-bb3f-5e5045bb4d27 67718-948 HUMAN OTC DRUG Garnier Fructis Antidandruff Intense Cleanse Pyrithione Zinc SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358 L'Oreal USA Florence Manufacturing PYRITHIONE ZINC 3.84 mL/384mL 67718-963_6b6b32f6-ec59-45f0-98b1-e1be3d648317 67718-963 HUMAN OTC DRUG Garnier Fructis Antidandruff Clear Control Salicylic Acid SHAMPOO TOPICAL 20110301 OTC MONOGRAPH FINAL part358H L'Oreal USA Florence Manufacturing SALICYLIC ACID 11.52 mL/384mL 67750-1234_ead891eb-55c6-4153-b5f5-e9b02075de62 67750-1234 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030228 UNAPPROVED MEDICAL GAS J & L Medical Services LLC OXYGEN 99 L/100L 67751-002_eb55b81b-e9e5-4b3f-b2a6-3994e913a103 67751-002 HUMAN OTC DRUG Handy Solutions Rubbing Alcohol ISOPROPYL ALCOHOL LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333A Navajo Manufacturing Company Inc. ISOPROPYL ALCOHOL 700 mg/mL 67751-009_8909f5e5-2267-44a0-a30c-e5b3882e8f89 67751-009 HUMAN OTC DRUG Handy Solutions GENUINE ASPIRIN BAYER Aspirin TABLET ORAL 20130821 OTC MONOGRAPH FINAL part343 Navajo Manufacturing Company Inc. ASPIRIN 325 mg/1 67751-011_49794b5a-d9d2-4fa1-9690-7cd9c2594602 67751-011 HUMAN OTC DRUG HAND SANITIZER ALCOHOL LIQUID TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part333E Navajo Manufacturing Company Inc. ALCOHOL 36.58 mL/59mL 67751-011_7d49ec0b-bd39-4efa-a1cc-5701b7c7f992 67751-011 HUMAN OTC DRUG HAND SANITIZER Alcohol LIQUID TOPICAL 20110711 OTC MONOGRAPH NOT FINAL part333E Navajo Manufacturing Company Inc. ALCOHOL 36.58 mL/59mL 67751-011_cdc1cd37-db67-4d32-83a2-2cf255502f96 67751-011 HUMAN OTC DRUG HAND SANITIZER alcohol LIQUID TOPICAL 20110630 OTC MONOGRAPH NOT FINAL part333E Navajo Manufacturing Company Inc. ALCOHOL 6.2 mL/10mL 67751-052_65a0acbf-abb8-4444-a74c-4b96c8d87c69 67751-052 HUMAN OTC DRUG Handy Solutions Crest Cavity Protection FLUORIDE ANTICAVITY SODIUM FLUORIDE PASTE, DENTIFRICE ORAL 20130624 OTC MONOGRAPH FINAL part355 Navajo Manufacturing Company Inc SODIUM FLUORIDE .15 g/100g 67751-053_49087629-8798-47c1-afc4-77a3425ae32b 67751-053 HUMAN OTC DRUG Head and Shoulders Classic Clean Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20130531 OTC MONOGRAPH FINAL part358H Navajo Manufacturing Company Inc PYRITHIONE ZINC 10 mg/mL 67751-058_97a90348-bca0-4386-b263-339e2f38420d 67751-058 HUMAN OTC DRUG Degree Shower Clean Anti-perspirant and Deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20130603 OTC MONOGRAPH FINAL part350 Navajo Manufacturing Company Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 182 mg/g 67751-085_7d0e16b0-d2e7-4ae7-80ba-d02b0539a7dc 67751-085 HUMAN OTC DRUG Handy Solutions Instant Hand Sanitizer With Aloe And Vitamin E ALCOHOL LIQUID TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333E Navajo Manufacturing Company Inc. ALCOHOL 62 mL/100mL 67751-094_656b96fa-8545-4671-9e7a-36c3f8298ddd 67751-094 HUMAN OTC DRUG Handy Solutions Kidz Crest Sparkle Fun Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130821 OTC MONOGRAPH FINAL part355 Navajo Manufacturing Company Inc. SODIUM FLUORIDE .243 mg/100g 67751-095_f4ff486f-f651-44d8-bb4b-a79b74a62d26 67751-095 HUMAN OTC DRUG Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus Scope SODIUM FLUORIDE PASTE, DENTIFRICE ORAL 20130816 OTC MONOGRAPH FINAL part355 Navajo Manufacturing Company Inc SODIUM FLUORIDE .15 g/100g 67751-102_76d9b2e7-4f8e-4134-a9ab-7e23d8e2b5f4 67751-102 HUMAN OTC DRUG Handy Solutions LISTERINE ANTISEPTIC MOUTHWASH Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20130821 OTC MONOGRAPH NOT FINAL part356 Navajo Manufacturing Company Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 67751-103_d8e0c456-22ea-43e3-8977-f17a38d02329 67751-103 HUMAN OTC DRUG Handy Solutions Cool Mint LISTERINE ANTISEPTIC MOUTHWASH Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20130821 OTC MONOGRAPH NOT FINAL part356 Navajo Manufacturing Company Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 67751-130_338673d0-861f-4ef5-8570-0212379a1996 67751-130 HUMAN OTC DRUG Refresh Tears Lubricant CARBOXYMETHYLCELLULOSE SODIUM SOLUTION/ DROPS OPHTHALMIC 20040901 OTC MONOGRAPH FINAL part349 Navajo Manufacturing Company Inc. CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL 67751-131_79851f73-9c84-4559-9103-068c4a53ba92 67751-131 HUMAN OTC DRUG Colgate Total Clean Mint ANTIGINGIVITIS SODIUM FLUORIDE PASTE, DENTIFRICE ORAL 20130624 NDA NDA020231 Navajo Manufacturing Company Inc SODIUM FLUORIDE; TRICLOSAN .14; .3 g/100g; g/100g 67751-132_a82ca29d-9531-4efe-8ef0-95c0aec2ae2f 67751-132 HUMAN OTC DRUG Handy Solutions Colgate Cavity Protection SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20130816 OTC MONOGRAPH FINAL part355 Navajo Manufacturing Company Inc SODIUM MONOFLUOROPHOSPHATE .15 g/100g 67751-134_bed740fc-b821-40ea-9f11-d42e516f2716 67751-134 HUMAN OTC DRUG Handy Solutions Dove Cool Essential Cucumber and Green Tea Scent Anti-Perspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130816 OTC MONOGRAPH FINAL part350 Navajo Manufacturing Company Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g 67751-135_871c28b1-11ec-4e00-9dde-1a92cd74d933 67751-135 HUMAN OTC DRUG Lady Speed INVISIBLE DRY antiperspirant deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20130624 OTC MONOGRAPH FINAL part350 Navajo Manufacturing Company Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.4 g/100g 67751-140_2af930ea-9dbf-443e-ac6e-e50db60fb08a 67751-140 HUMAN OTC DRUG Handy Solutions Antiseptic Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20120418 OTC MONOGRAPH NOT FINAL part333A Navajo Manuracturing Company BENZALKONIUM CHLORIDE .13 g/100g 67752-0001_928c5bfc-70bc-4ff6-a6db-7b404538ec79 67752-0001 HUMAN OTC DRUG AMSure Alcohol Prep ISOPROPYL ALCOHOL SWAB TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333A Amsino International, Inc. ISOPROPYL ALCOHOL .7 mL/mL 67752-2003_9bd269b7-ebe5-4c99-8dd6-3023cdd3f3f0 67752-2003 HUMAN OTC DRUG AMSure Three Povidone-Iodine Swabsticks Povidone-Iodine SWAB TOPICAL 20120106 OTC MONOGRAPH FINAL part333C Amsino International, Inc. POVIDONE-IODINE .1 mg/mL 67760-001_a8720875-eb13-4a8e-a48f-6ac72cd27b99 67760-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130712 UNAPPROVED MEDICAL GAS Respiratory At Home Plus OXYGEN 99 L/100L 67767-117_12698fb6-1b50-4060-8904-bb1c620108d9 67767-117 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20080312 ANDA ANDA077475 Actavis South Atlantic LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 67767-133_9a504cce-efd9-44f7-b67e-00f55a4295c9 67767-133 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080312 ANDA ANDA077455 Actavis South Atlantic LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 67767-135_9a504cce-efd9-44f7-b67e-00f55a4295c9 67767-135 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100719 ANDA ANDA077455 Actavis South Atlantic LLC BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 67767-141_8d33a46e-5c0b-4af4-ae66-9130f52e9aef 67767-141 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100331 ANDA ANDA077285 Actavis South Atlantic LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 67767-142_8d33a46e-5c0b-4af4-ae66-9130f52e9aef 67767-142 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100331 ANDA ANDA077285 Actavis South Atlantic LLC BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 67767-171_9a504cce-efd9-44f7-b67e-00f55a4295c9 67767-171 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100719 ANDA ANDA077455 Actavis South Atlantic LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 67767-200_937d1bad-0c6a-43ab-8dc7-0bb376054d80 67767-200 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120103 ANDA ANDA078458 Actavis South Atlantic LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 67767-201_937d1bad-0c6a-43ab-8dc7-0bb376054d80 67767-201 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120103 ANDA ANDA078458 Actavis South Atlantic LLC METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 67767-202_937d1bad-0c6a-43ab-8dc7-0bb376054d80 67767-202 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120103 ANDA ANDA078458 Actavis South Atlantic LLC METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 67772-011_ea5ce013-7202-4b0d-af22-d6df4b7a2f8d 67772-011 HUMAN OTC DRUG Hand Sanitizer CDS Office Products Alcohol LIQUID TOPICAL 20100808 OTC MONOGRAPH NOT FINAL part333 Jiangxi Sencen Hygienic Products Co., Ltd. ALCOHOL 62 g/100g 67772-015_c5829dd3-a1f8-467b-bca9-db949b0dcdf6 67772-015 HUMAN OTC DRUG EZY-TM CHLORHEXIDINE GLUCONATE CLOTH TOPICAL 20110712 UNAPPROVED DRUG OTHER Jiangxi Sencen Hygienic Products Co., Ltd. CHLORHEXIDINE GLUCONATE 2 g/100g 67773-001_74a33f6c-5ef3-411f-b352-daf82eb3ea1c 67773-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100712 UNAPPROVED MEDICAL GAS Oxygen Plus OXYGEN 99 L/100L 67777-001_3e1d46cb-a7a3-4bdb-9f5b-b612134d2c24 67777-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Oxygen Plus OXYGEN 99 L/100L 67777-100_890dd3e0-7033-4fc2-9893-5fec73b7c054 67777-100 HUMAN OTC DRUG povidine iodine povidine iodine SOLUTION TOPICAL 20020103 OTC MONOGRAPH FINAL part333C Dynarex Corporation POVIDONE-IODINE 10 mL/100mL 67777-110_434448c6-21ce-4e2e-85ee-38f366e6510b 67777-110 HUMAN OTC DRUG povidine iodine povidine iodine SOLUTION TOPICAL 20020103 OTC MONOGRAPH FINAL part333C Dynarex Corporation POVIDONE-IODINE 7.5 mL/100mL 67777-120_3254578d-a959-4e2b-880d-56b12be39c14 67777-120 HUMAN OTC DRUG Alcohol Swabstick Alcohol Swabstick SWAB TOPICAL 20100301 OTC MONOGRAPH FINAL part344 Dynarex Corporation ISOPROPYL ALCOHOL 1.4 mL/1 67777-121_09e84582-1bb5-4fc6-9e39-1da1d974aecd 67777-121 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation ISOPROPYL ALCOHOL .7 mL/mL 67777-130_6e0bb046-ea9e-471b-82aa-815a291dbaef 67777-130 HUMAN OTC DRUG povidine iodine povidine iodine SWAB TOPICAL 20100510 OTC MONOGRAPH FINAL part333C Dynarex Corporation POVIDONE-IODINE 10 mg/mL 67777-140_56609c63-de60-4111-a317-4f0fc1db502b 67777-140 HUMAN OTC DRUG povidine iodine povidine iodine SWAB TOPICAL 20100510 OTC MONOGRAPH FINAL part333 Dynarex Corporation POVIDONE-IODINE 10 mL/100mL 67777-160_4385d760-1b33-4570-82d6-7fec76a38b34 67777-160 HUMAN OTC DRUG Lemon Glycerin Glycerin SWAB ORAL 20110621 OTC MONOGRAPH NOT FINAL part356 Dynarex Corporation GLYCERIN 7.5 mL/100mL 67777-171_d7333da1-d49a-4966-b31b-35aa1f81665e 67777-171 HUMAN OTC DRUG Morning Fresh Sodium Monofluorophosphate PASTE ORAL 20100608 OTC MONOGRAPH FINAL part355 Dynarex Corporation SODIUM MONOFLUOROPHOSPHATE 1 mg/g 67777-172_59c0872c-839a-4289-8af0-7f53c9784010 67777-172 HUMAN OTC DRUG Morning Fresh Sodium Monofluorophosphate PASTE ORAL 20130405 OTC MONOGRAPH FINAL part355 Dynarex Corporation SODIUM MONOFLUOROPHOSPHATE 1 mg/g 67777-173_640c16fc-0e0f-4b38-a4f7-eedb6b90059e 67777-173 HUMAN OTC DRUG Morning Fresh Sodium Monofluorophosphate PASTE ORAL 20130405 OTC MONOGRAPH FINAL part355 Dynarex Corporation SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 67777-174_ef3e3c40-6cd3-4f6f-a2c7-51ea1c64cf83 67777-174 HUMAN OTC DRUG Morning Fresh Sodium Fluoride PASTE ORAL 20140514 OTC MONOGRAPH FINAL part355 Dynarex Corporation SODIUM FLUORIDE 2.2 mg/g 67777-211_98f2d4bc-3a59-45d5-91c1-11833a06dc89 67777-211 HUMAN OTC DRUG PETROLATUM PETROLATUM JELLY TOPICAL 20100131 OTC MONOGRAPH FINAL part347 Dynarex Corporation PETROLATUM 1 g/g 67777-214_78a75618-8d98-4dc6-845a-4e10daaff9cd 67777-214 HUMAN OTC DRUG Vitamin A D PETROLATUM OINTMENT TOPICAL 20100324 OTC MONOGRAPH FINAL part347 Dynarex Corporation PETROLATUM .76 g/g 67777-215_4b346a37-9ad3-4854-8a45-79a8764f5016 67777-215 HUMAN OTC DRUG Vitamin A D PETROLATUM OINTMENT TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Dynarex Corporation PETROLATUM .93 g/g 67777-217_795e566e-737a-4501-a6e8-ac735d65f1f2 67777-217 HUMAN OTC DRUG bacitracin zinc, neomycin sulfate and polymyxin b sulfate bacitracin zinc, neomycin sulfate and polymyxin b sulfate OINTMENT TOPICAL 20091201 OTC MONOGRAPH FINAL part333B Dynarex Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [iU]/g; mg/g; [iU]/g 67777-219_eb0099e9-bf25-48df-b434-17eb039c31da 67777-219 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20091201 OTC MONOGRAPH FINAL part333B Dynarex Corporation BACITRACIN 500 [iU]/g 67777-220_c161ee33-f163-420c-8884-c59efc7600eb 67777-220 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20091201 OTC MONOGRAPH FINAL part333B Dynarex Corporation BACITRACIN ZINC 500 [USP'U]/g 67777-222_7051fce6-dc97-4d02-85a7-0f26c545a1ed 67777-222 HUMAN OTC DRUG Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20100316 OTC MONOGRAPH FINAL part347 Dynarex Corporation ZINC OXIDE 200 mg/g 67777-224_c2021669-a5b8-4b54-bf4d-74f2922efc69 67777-224 HUMAN OTC DRUG Hydrocortisone Hydrocortisone Acetate CREAM TOPICAL 20100202 OTC MONOGRAPH NOT FINAL part348 Dynarex Corporation HYDROCORTISONE ACETATE 1 g/100g 67777-226_a137e963-1fa0-4772-a6a1-1d7a01bf1040 67777-226 HUMAN OTC DRUG zinc oxide zinc oxide OINTMENT TOPICAL 20110201 OTC MONOGRAPH FINAL part347 Dynarex Corporation ZINC OXIDE 1.8 g/100g 67777-228_00f98114-0277-4d4f-ba9d-59e1af5e8fa9 67777-228 HUMAN OTC DRUG Dynashield with Dimethicone zinc oxide and dimethicone CREAM TOPICAL 20090901 OTC MONOGRAPH FINAL part347 Dynarex Corporation DIMETHICONE; ZINC OXIDE 18; 200 mg/g; mg/g 67777-231_7c21a5e5-9390-40bb-95d7-165f1c842aa5 67777-231 HUMAN OTC DRUG Dynarex Antifungal antifungal CREAM TOPICAL 20100518 OTC MONOGRAPH FINAL part333C Dynarex Corporation CLOTRIMAZOLE 1 g/100g 67777-232_a2902a28-599d-4c10-8a0c-957b4bed94f2 67777-232 HUMAN OTC DRUG Lanolin Lanolin OINTMENT TOPICAL 20100512 OTC MONOGRAPH FINAL part347 Dynarex Corporation LANOLIN 50 g/100g 67777-233_6575bb22-da84-4249-a064-8e0db3d8e419 67777-233 HUMAN OTC DRUG Dynarex Hydrogel glycerin GEL TOPICAL 20100526 OTC MONOGRAPH FINAL part346 Dynarex Corporation GLYCERIN 20 g/100g 67777-234_5c83272b-4e2b-4400-b709-681fdc60b895 67777-234 HUMAN OTC DRUG Menthol and Zinc Oxide Menthol and Zinc Oxide OINTMENT TOPICAL 20100511 OTC MONOGRAPH FINAL part347 Dynarex Corporation MENTHOL; ZINC OXIDE .44; 21 g/100g; g/100g 67777-235_30ff050f-234c-41e0-8552-c780c02b7574 67777-235 HUMAN OTC DRUG Benzocaine Benzocaine SWAB TOPICAL 20110124 OTC MONOGRAPH FINAL part348 Dynarex Corporation BENZOCAINE .12 mL/1 67777-237_489256ed-4c2a-4ab5-9728-612498b677fa 67777-237 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20100202 OTC MONOGRAPH FINAL part348 Dynarex Corporation HYDROCORTISONE 1 g/100g 67777-238_3865719d-c769-45ea-b91a-126f78dfd72a 67777-238 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20091201 OTC MONOGRAPH FINAL part333B Dynarex Corporation BACITRACIN ZINC 500 [iU]/g 67777-239_656a9b59-1f64-41e4-9f8d-6870a1eda963 67777-239 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20091201 OTC MONOGRAPH FINAL part333B Dynarex Corporation BACITRACIN ZINC 500 [iU]/g 67777-240_17776a1c-d279-4cdc-8860-ce18c2ceca34 67777-240 HUMAN OTC DRUG bacitracin zinc, neomycin sulfate and polymyxin b sulfate bacitracin zinc, neomycin sulfate and polymyxin b sulfate OINTMENT TOPICAL 20110316 OTC MONOGRAPH FINAL part333B Dynarex Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 67777-243_b8f6de9b-7011-4467-8503-fecb9c61d7c4 67777-243 HUMAN OTC DRUG BZK Pads Benzalkonium Chloride SWAB TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL 67777-244_dc72eb70-9500-409c-b763-ece157e6dee0 67777-244 HUMAN OTC DRUG BZK Pads Benzalkonium Chloride SWAB TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL 67777-245_25d83334-f978-4569-8c03-b7bcca7b7ca4 67777-245 HUMAN OTC DRUG BZK Pads Benzalkonium Chloride SWAB TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL 67777-246_4ab503a7-b332-4ca1-ad11-e58f99ad0b5d 67777-246 HUMAN OTC DRUG Benzocaine Benzocaine SWAB TOPICAL 20110720 OTC MONOGRAPH FINAL part348 Dynarex Corporation BENZOCAINE 60 mg/mL 67777-251_fd97cde7-7b3b-40c0-8dbd-86dc1005fced 67777-251 HUMAN OTC DRUG Ammonia Inhalants Ammonia Inhalants INHALANT RESPIRATORY (INHALATION) 19760214 UNAPPROVED DRUG OTHER Dynarex Corporation AMMONIA .05 g/.33mL 67777-300_53857704-e6fd-4174-bf40-71251d644bc6 67777-300 HUMAN OTC DRUG Alcohol Alcohol SWAB TOPICAL 20120607 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation ISOPROPYL ALCOHOL .7 mL/mL 67777-301_99a0044c-71d6-4377-9834-8c573d088bf0 67777-301 HUMAN OTC DRUG povidine iodine povidine iodine SWAB TOPICAL 20120210 OTC MONOGRAPH FINAL part333C Dynarex Corporation POVIDONE-IODINE 10 mL/100mL 67777-304_39d6dde5-524e-46fe-b3e0-3afcc2bfb116 67777-304 HUMAN OTC DRUG Alcohol Isopropyl Alcohol LIQUID TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation ISOPROPYL ALCOHOL .7 mL/mL 67777-305_8a2edc76-a746-436e-bb18-2dd174fd8466 67777-305 HUMAN OTC DRUG Alcohol Isopropyl Alcohol LIQUID TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation ISOPROPYL ALCOHOL .99 mL/mL 67777-306_cbff770c-92d2-481a-8ba5-6f08854c24ae 67777-306 HUMAN OTC DRUG Dynarex HP 3 Hydrogen peroxide LIQUID TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part356 Dynarex Corporation HYDROGEN PEROXIDE 2.65 mL/100mL 67777-307_c3984737-3b99-4011-b17b-dc3d3ffec4be 67777-307 HUMAN OTC DRUG Dynarex Green ALCOHOL LIQUID TOPICAL 20140128 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation ALCOHOL .3 mL/mL 67777-308_f470020d-a25d-4ed5-ae66-d5f6e3b0bd2f 67777-308 HUMAN OTC DRUG Dynarex Green ALCOHOL LIQUID TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation ALCOHOL .3 mL/mL 67777-400_b582c7fd-fb35-42a1-a897-3bb219d19851 67777-400 HUMAN OTC DRUG PETROLATUM PETROLATUM JELLY TOPICAL 20100323 OTC MONOGRAPH FINAL part347 Dynarex Corporation PETROLATUM 1 g/g 67777-401_23a57e7f-1318-42e3-ba0b-7a1849000cf4 67777-401 HUMAN OTC DRUG Mineral Oil MINERAL OIL ENEMA RECTAL 20120829 OTC MONOGRAPH NOT FINAL part334 Dynarex Corporation MINERAL OIL 118 mg/118mL 67777-402_1b7d3bcf-b2b6-43ff-9422-5bea71d87f3b 67777-402 HUMAN OTC DRUG Saline Enema Sodium Phosphate Monobasic, Sodium Phosphate Dibasic ENEMA RECTAL 20120829 OTC MONOGRAPH NOT FINAL part334 Dynarex Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL 67777-404_4b1b8aeb-f368-46a2-8bfd-516e2a1436b9 67777-404 HUMAN OTC DRUG DYNAREX LAXATIVE MINERAL OIL LIQUID ORAL 20140305 OTC MONOGRAPH NOT FINAL part334 Dynarex Corporation MINERAL OIL 99 g/100g 67777-405_8258c2d4-e0f9-45fe-8ce0-bf9acf607524 67777-405 HUMAN OTC DRUG Medicaine Sting and Bite Benzocaine SWAB TOPICAL 19760214 UNAPPROVED DRUG OTHER Dynarex Corporation BENZOCAINE .12 g/.6mL 67777-406_8b291cc6-df75-445a-bad5-6cd29f05fa2c 67777-406 HUMAN OTC DRUG Muscle rub Menthol, Camphor, Methyl Salicylate CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part348 Dynarex Corporation CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g 67777-407_92fa4cde-86a1-4fec-b4dc-71be29ff8d6b 67777-407 HUMAN OTC DRUG Dynashield zinc oxide OINTMENT TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Dynarex Corporation ZINC OXIDE 1.8 g/100g 67777-408_20f612df-d984-44f3-8ccf-2c073be8a4b9 67777-408 HUMAN OTC DRUG Dynashield with Dimethicone zinc oxide OINTMENT TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Dynarex Corporation DIMETHICONE; ZINC OXIDE 1.8; 2 g/100g; g/100g 67777-409_eb1c3ee3-da0c-4fc9-b9ca-dae83ae09492 67777-409 HUMAN OTC DRUG Menthol and Zinc Oxide Menthol and Zinc Oxide OINTMENT TOPICAL 20141011 OTC MONOGRAPH FINAL part347 Dynarex Corporation MENTHOL; ZINC OXIDE .44; 21 g/100g; g/100g 67777-410_75d4bffb-cc22-40c2-a8cd-442239d4067c 67777-410 HUMAN OTC DRUG Lanashield Lanolin OINTMENT TOPICAL 20141012 OTC MONOGRAPH FINAL part347 Dynarex Corporation LANOLIN 50 g/100g 67781-251_64f121d8-f082-471a-9756-cc5ac544543c 67781-251 HUMAN PRESCRIPTION DRUG Uniphyl theophylline anhydrous TABLET ORAL 19820901 ANDA ANDA087571 Purdue Pharmaceutical Products LP THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 67781-252_64f121d8-f082-471a-9756-cc5ac544543c 67781-252 HUMAN PRESCRIPTION DRUG Uniphyl theophylline anhydrous TABLET ORAL 19960607 ANDA ANDA040086 Purdue Pharmaceutical Products LP THEOPHYLLINE ANHYDROUS 600 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 67795-033_6572c787-f082-4140-910b-45878f2e25c2 67795-033 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000110 UNAPPROVED MEDICAL GAS RoadRunner Oxygen Service, Inc. OXYGEN 99 L/100L 67795-100_bdccab07-090e-4f6f-a578-014f3c9948c3 67795-100 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Roadrunner Oxygen Service NITROGEN 99 L/100L 67850-011_3c219760-e94e-de53-2b3a-2155fe2224b1 67850-011 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101018 ANDA ANDA090767 Methapharm, Inc. LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67850-012_3c219760-e94e-de53-2b3a-2155fe2224b1 67850-012 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101018 ANDA ANDA090767 Methapharm, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67850-013_3c219760-e94e-de53-2b3a-2155fe2224b1 67850-013 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101018 ANDA ANDA090767 Methapharm, Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67850-014_3c219760-e94e-de53-2b3a-2155fe2224b1 67850-014 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101018 ANDA ANDA090767 Methapharm, Inc. LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67857-700_8d674ec6-61e4-41f2-91f8-4a0df9c141b9 67857-700 HUMAN PRESCRIPTION DRUG SECTRAL acebutolol hydrochloride CAPSULE ORAL 19841228 NDA NDA018917 Promius Pharma, LLC ACEBUTOLOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67857-701_8d674ec6-61e4-41f2-91f8-4a0df9c141b9 67857-701 HUMAN PRESCRIPTION DRUG SECTRAL acebutolol hydrochloride CAPSULE ORAL 19841228 NDA NDA018917 Promius Pharma, LLC ACEBUTOLOL HYDROCHLORIDE 400 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67857-705_1b6fa629-ed24-8a9c-de2a-36bf69ea2e4d 67857-705 HUMAN PRESCRIPTION DRUG TENEX guanfacine hydrochloride TABLET ORAL 19861027 NDA NDA019032 Promius Pharma, LLC GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 67857-706_1b6fa629-ed24-8a9c-de2a-36bf69ea2e4d 67857-706 HUMAN PRESCRIPTION DRUG TENEX guanfacine hydrochloride TABLET ORAL 19861027 NDA NDA019032 Promius Pharma, LLC GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 67857-804_903dbe4b-2e34-4359-a442-baf4e96c0dac 67857-804 HUMAN PRESCRIPTION DRUG Cloderm clocortolone pivalate CREAM TOPICAL 19770822 NDA NDA017765 Promius Pharma, LLC CLOCORTOLONE PIVALATE .001 g/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 67858-001_bb0d0cdf-8539-46f5-91fe-83e9873cb3bf 67858-001 HUMAN OTC DRUG Ovation Instant Hand Sanitizer Benzethonium chloride LIQUID TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part333A QuestVapco Corporation BENZETHONIUM CHLORIDE 1 mg/50mL 67858-515_21559649-01ea-40a3-a847-b399a55da3d5 67858-515 HUMAN OTC DRUG hand san INSTANT HAND SANITIZER HUSKY 515 GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 Environmental Chemical Inc. ALCOHOL 600 mL/1000mL 67868-054_bfa1413c-d38a-4d3b-b129-9eb5e323dec0 67868-054 HUMAN OTC DRUG Freds Antiseptic Wash BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE LIQUID TOPICAL 20100708 OTC MONOGRAPH FINAL part333A Pharma Pac, LLC BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 20 mg/mL; mg/mL 67868-117_d1f9eabc-99ec-4daa-a999-47aaca7d1aa0 67868-117 HUMAN OTC DRUG BENZOCAINE and RESORCINOL BENZOCAINE and RESORCINOL CREAM TOPICAL 20090519 OTC MONOGRAPH NOT FINAL part348 Pharma Pac, LLC BENZOCAINE; RESORCINOL 200; 20 mg/g; mg/g 67871-007_6b61a6f9-0cc7-47bf-a600-ae8bb89a9501 67871-007 HUMAN PRESCRIPTION DRUG Elliotts B sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate INJECTION INTRATHECAL 20060927 NDA NDA020577 QOL Medical, LLC ANHYDROUS DEXTROSE; CALCIUM CHLORIDE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE 8; 2; 3; 3; 19; 73; 2 mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 67871-111_889f8f9d-c8aa-4ea1-903a-8a2b8e699a9e 67871-111 HUMAN PRESCRIPTION DRUG SUCRAID sacrosidase SOLUTION ORAL 19980409 NDA NDA020772 QOL Medical, LLC SACROSIDASE 8500 [iU]/mL Sucrose-specific Enzyme [EPC] 67871-479_c863b995-b91f-4ee3-b9a4-493cf812f722 67871-479 HUMAN PRESCRIPTION DRUG Ethamolin Ethanolamine Oleate INJECTION, SOLUTION INTRAVENOUS 19981222 NDA NDA019357 QOL Medical, LLC. ETHANOLAMINE OLEATE 50 mg/mL Sclerosing Activity [MoA],Sclerosing Agent [EPC],Vascular Sclerosing Activity [PE] 67877-105_75cdeaee-7a49-4386-b4e1-baca5e98afac 67877-105 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Ascend Laboratories LLC BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 67877-106_75cdeaee-7a49-4386-b4e1-baca5e98afac 67877-106 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 Ascend Laboratories LLC BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 67877-116_aa8e14c1-fbfd-4e4d-b59e-2d4ae1ca815f 67877-116 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20120116 ANDA ANDA090635 Ascend Laboratories, LLC METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 67877-119_95a71bca-6bdd-4a52-bab5-96bce3c03c21 67877-119 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20090206 ANDA ANDA078329 Ascend Laboratories, LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67877-120_95a71bca-6bdd-4a52-bab5-96bce3c03c21 67877-120 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20090206 ANDA ANDA078329 Ascend Laboratories, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67877-121_95a71bca-6bdd-4a52-bab5-96bce3c03c21 67877-121 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20090206 ANDA ANDA078329 Ascend Laboratories, LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67877-124_4d53c3ed-098a-4540-8866-29f02084ef73 67877-124 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 19851223 NDA NDA018810 Ascend Laboratories, LLC SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 67877-146_92b119d2-8554-4610-a37d-93d9e8e300f0 67877-146 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 Ascend Laboratories, LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67877-147_92b119d2-8554-4610-a37d-93d9e8e300f0 67877-147 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 Ascend Laboratories, LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67877-148_92b119d2-8554-4610-a37d-93d9e8e300f0 67877-148 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20120628 ANDA ANDA071457 Ascend Laboratories, LLC TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67877-149_92b119d2-8554-4610-a37d-93d9e8e300f0 67877-149 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20120628 ANDA ANDA071457 Ascend Laboratories, LLC TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 67877-159_93cce808-2234-4bb5-a03d-15d037800bb7 67877-159 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20130301 ANDA ANDA201991 Ascend Laboratories, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 67877-164_2ff6983b-28c6-4730-8ba6-62c1113115be 67877-164 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110622 ANDA ANDA200694 Ascend Laboratories, LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 67877-165_2ff6983b-28c6-4730-8ba6-62c1113115be 67877-165 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110622 ANDA ANDA200694 Ascend Laboratories, LLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 67877-166_2ff6983b-28c6-4730-8ba6-62c1113115be 67877-166 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110622 ANDA ANDA200694 Ascend Laboratories, LLC LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 67877-167_2ff6983b-28c6-4730-8ba6-62c1113115be 67877-167 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110622 ANDA ANDA200694 Ascend Laboratories, LLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 67877-169_48f2e53d-f154-4ebf-b7cb-2d17a452f20b 67877-169 HUMAN PRESCRIPTION DRUG ondansetron ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Ascend Laboratories, LLC ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 67877-170_48f2e53d-f154-4ebf-b7cb-2d17a452f20b 67877-170 HUMAN PRESCRIPTION DRUG ondansetron ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Ascend Laboratories, LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 67877-171_0952644e-ef42-4dcb-b07f-6901cda78ec0 67877-171 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100628 ANDA ANDA079220 Ascend Laboratories, LLC ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 67877-171_4dcb2dbc-c4c1-43a4-950d-b24062e4d174 67877-171 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100628 ANDA ANDA079220 Ascend Laboratories, LLC ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 67877-184_de33da5e-1833-4875-915c-578380409b54 67877-184 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride TABLET ORAL 20100101 ANDA ANDA078969 Ascend Laboratories, LLC GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 67877-197_53dfef4a-a4b4-4509-b075-a01ad04b9a6d 67877-197 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20101020 ANDA ANDA078925 Ascend Laboratories, LLC AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 67877-198_53dfef4a-a4b4-4509-b075-a01ad04b9a6d 67877-198 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20101020 ANDA ANDA078925 Ascend Laboratories, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 67877-199_53dfef4a-a4b4-4509-b075-a01ad04b9a6d 67877-199 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20101020 ANDA ANDA078925 Ascend Laboratories, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 67877-210_2f44db39-e1d9-451e-ba31-e4b10366a430 67877-210 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20101215 ANDA ANDA078989 Ascend Laboratories, LLC ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 67877-211_2f44db39-e1d9-451e-ba31-e4b10366a430 67877-211 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20101215 ANDA ANDA078989 Ascend Laboratories, LLC ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV 67877-215_c479a484-940d-413b-9275-1fcd7fca060a 67877-215 HUMAN PRESCRIPTION DRUG Cefuroxime axetil Cefuroxime axetil TABLET, FILM COATED ORAL 20101201 ANDA ANDA065496 Ascend Laboratories, LLC CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 67877-216_c479a484-940d-413b-9275-1fcd7fca060a 67877-216 HUMAN PRESCRIPTION DRUG Cefuroxime axetil Cefuroxime axetil TABLET, FILM COATED ORAL 20101201 ANDA ANDA065496 Ascend Laboratories, LLC CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 67877-217_5036898b-af0f-40e5-a3b8-b1a8ba947de5 67877-217 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Ascend Laboratories, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 67877-218_5036898b-af0f-40e5-a3b8-b1a8ba947de5 67877-218 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Ascend Laboratories, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 67877-219_c000482e-30ee-4143-a39d-92fbc153df26 67877-219 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110120 ANDA ANDA090836 Ascend Laboratories, LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 67877-220_c000482e-30ee-4143-a39d-92fbc153df26 67877-220 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110120 ANDA ANDA090836 Ascend Laboratories, LLC CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 67877-221_5036898b-af0f-40e5-a3b8-b1a8ba947de5 67877-221 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Ascend Laboratories, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 67877-222_2f3d901a-6f50-4893-abc6-5b325af3e740 67877-222 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Ascend Laboratories, LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67877-223_2f3d901a-6f50-4893-abc6-5b325af3e740 67877-223 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Ascend Laboratories, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67877-224_2f3d901a-6f50-4893-abc6-5b325af3e740 67877-224 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Ascend Laboratories, LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 67877-225_519c5699-0704-4d4e-b69b-d6575631d558 67877-225 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET, FILM COATED ORAL 20111128 ANDA ANDA091249 Ascend Laboratories, LLC MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 67877-229_4803da82-c0c2-4c1b-bb89-3bc39585058d 67877-229 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION OPHTHALMIC 20110309 ANDA ANDA077259 Ascend Laboratories, LLC TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 67877-230_673ceb5f-38ef-44e1-8da9-f5f162ef8796 67877-230 HUMAN PRESCRIPTION DRUG Mycophenolate mofetil Mycophenolate mofetil POWDER, FOR SUSPENSION ORAL 20141117 ANDA ANDA203005 Ascend Laboratories, LLC MYCOPHENOLATE MOFETIL 200 mg/mL Antimetabolite Immunosuppressant [EPC] 67877-240_6b8eebc0-0c5c-40b2-b449-e10d7658f2f2 67877-240 HUMAN PRESCRIPTION DRUG ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET ORAL 20110901 ANDA ANDA090258 Ascend Laboratories, LLC ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 67877-241_6b8eebc0-0c5c-40b2-b449-e10d7658f2f2 67877-241 HUMAN PRESCRIPTION DRUG ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET ORAL 20110901 ANDA ANDA090258 Ascend Laboratories, LLC ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 67877-242_f2e10990-cec1-4d81-9f70-311ee8114f9e 67877-242 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Ascend Laboratories, LLC QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 67877-245_f2e10990-cec1-4d81-9f70-311ee8114f9e 67877-245 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Ascend Laboratories, LLC QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] 67877-246_f2e10990-cec1-4d81-9f70-311ee8114f9e 67877-246 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Ascend Laboratories, LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 67877-247_f2e10990-cec1-4d81-9f70-311ee8114f9e 67877-247 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Ascend Laboratories, LLC QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 67877-248_f2e10990-cec1-4d81-9f70-311ee8114f9e 67877-248 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Ascend Laboratories, LLC QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 67877-249_f2e10990-cec1-4d81-9f70-311ee8114f9e 67877-249 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Ascend Laboratories, LLC QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 67877-250_f2e10990-cec1-4d81-9f70-311ee8114f9e 67877-250 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Ascend Laboratories, LLC QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 67877-251_235cc145-0232-4504-b4f2-fa6dd5f02a2c 67877-251 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 Ascend Laboratories, LLC TRIAMCINOLONE ACETONIDE 1 mg/g 67877-254_c000482e-30ee-4143-a39d-92fbc153df26 67877-254 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120604 ANDA ANDA090836 Ascend Laboratories, LLC CEPHALEXIN 333 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 67877-255_c000482e-30ee-4143-a39d-92fbc153df26 67877-255 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120604 ANDA ANDA090836 Ascend Laboratories, LLC CEPHALEXIN 750 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 67877-266_519c5699-0704-4d4e-b69b-d6575631d558 67877-266 HUMAN PRESCRIPTION DRUG mycophenolate mofetil mycophenolate mofetil CAPSULE ORAL 20100101 ANDA ANDA200197 Ascend Laboratories, LLC MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 67877-268_2c1bb382-e246-4976-aaa1-6aac9394eaaf 67877-268 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium, Sulfur Sulfacetamide Sodium, Sulfur LOTION TOPICAL 20111108 UNAPPROVED DRUG OTHER Ascend Laboratories, LLC SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 67877-269_ff2f0d9b-5aea-4a43-968c-8acd9eb02f64 67877-269 HUMAN PRESCRIPTION DRUG Pramoxine-HC Hydrocortisone / Chloroxylenol / Pramoxine HCl SOLUTION/ DROPS AURICULAR (OTIC) 20110926 UNAPPROVED DRUG OTHER Ascend Laboratories, LLC CHLOROXYLENOL; HYDROCORTISONE; PRAMOXINE HYDROCHLORIDE 1; 10; 10 mg/mL; mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 67877-272_324d6901-cca8-4177-9cb9-fa7169d6cd3e 67877-272 HUMAN PRESCRIPTION DRUG Urea Urea CREAM TOPICAL 20120116 UNAPPROVED DRUG OTHER Ascend Laboratories, LLC UREA 400 mg/g 67877-273_324d6901-cca8-4177-9cb9-fa7169d6cd3e 67877-273 HUMAN PRESCRIPTION DRUG Urea Urea LOTION TOPICAL 20120116 UNAPPROVED DRUG OTHER Ascend Laboratories, LLC UREA 400 mg/mL 67877-290_e9bd55cd-318f-4dae-8555-67b954205545 67877-290 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100524 ANDA ANDA200737 Ascend Laboratories, LLC HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 67877-291_e9bd55cd-318f-4dae-8555-67b954205545 67877-291 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20091124 ANDA ANDA200737 Ascend Laboratories, LLC HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 67877-292_e9bd55cd-318f-4dae-8555-67b954205545 67877-292 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100524 ANDA ANDA200737 Ascend Laboratories, LLC HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 67877-293_e9bd55cd-318f-4dae-8555-67b954205545 67877-293 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100524 ANDA ANDA200737 Ascend Laboratories, LLC HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 67877-294_20b162c8-6e92-4008-a075-fd362c42301c 67877-294 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120222 ANDA ANDA090796 Ascend Laboratories, LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67877-295_20b162c8-6e92-4008-a075-fd362c42301c 67877-295 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120222 ANDA ANDA090796 Ascend Laboratories, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67877-296_20b162c8-6e92-4008-a075-fd362c42301c 67877-296 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120222 ANDA ANDA090796 Ascend Laboratories, LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 67877-305_17d56b39-9fd8-4253-b33a-d54f2cc82ef5 67877-305 HUMAN PRESCRIPTION DRUG Urea Urea CREAM TOPICAL 20130601 UNAPPROVED DRUG OTHER Ascend Laboratories, LLC UREA 390 mg/g 67877-312_1895dc98-ff36-4d29-9e00-b577de53a837 67877-312 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate Hydrocortisone Acetate SUPPOSITORY RECTAL 20131001 UNAPPROVED DRUG OTHER Ascend Laboratories, LLC HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 67905-0001_dc2c7562-dfe3-44c0-b849-a9bb7d267450 67905-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091014 UNAPPROVED MEDICAL GAS Osborn Drugs Inc OXYGEN 99 L/100L 67919-011_7eed8741-5e7c-4b68-9a56-f18beb38a6a7 67919-011 HUMAN PRESCRIPTION DRUG Cubicin Daptomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20030912 NDA NDA021572 Cubist Pharmaceuticals, Inc. DAPTOMYCIN 500 mg/10mL Lipopeptide Antibacterial [EPC],Lipopeptides [Chemical/Ingredient] 67919-020_c527840e-83ee-4cbd-a6fd-5c6c58bcd961 67919-020 HUMAN PRESCRIPTION DRUG Entereg alvimopan CAPSULE ORAL 20120416 NDA NDA021775 Cubist Pharmaceuticals, Inc. ALVIMOPAN 12 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] 67919-030_911fc3b8-8d94-4541-a48c-5ab7e0ff826c 67919-030 HUMAN PRESCRIPTION DRUG ZERBAXA ceftolozane sulfate and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141219 NDA NDA206829 Cubist Pharmaceuticals, Inc. CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM 1; .5 g/1; g/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 67919-040_1091d1d9-8f24-4601-9423-7ebfac5863b4 67919-040 HUMAN PRESCRIPTION DRUG SIVEXTRO tedizolid phosphate POWDER, FOR SOLUTION INTRAVENOUS 20140620 NDA NDA205436 Cubist Pharmaceuticals, Inc. TEDIZOLID PHOSPHATE 200 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] 67919-041_1091d1d9-8f24-4601-9423-7ebfac5863b4 67919-041 HUMAN PRESCRIPTION DRUG SIVEXTRO tedizolid phosphate TABLET, COATED ORAL 20140620 NDA NDA205435 Cubist Pharmaceuticals, Inc. TEDIZOLID PHOSPHATE 200 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] 67933-0003_45417465-164e-4095-b6a0-19d2cb81b787 67933-0003 HUMAN OTC DRUG PerCara Original Medicated Powder Menthol, Zinc Oxide POWDER TOPICAL 20120822 OTC MONOGRAPH FINAL part348 Willard Manufacturing Inc. MENTHOL; ZINC OXIDE .1; 1 g/100g; g/100g 67938-0105_ada6ff1f-ad9e-4dc5-86a3-09a539a0da20 67938-0105 HUMAN OTC DRUG Eight Hour Cream Skin Protectant Petrolatum LOTION TOPICAL 20091103 OTC MONOGRAPH FINAL part347 Elizabeth Arden, Inc PETROLATUM 28.4 g/50g 67938-0577_281b08c1-d524-47ba-9635-16ead1dcc9b6 67938-0577 HUMAN OTC DRUG Intervene Daily Moisture SPF 15 Oil Free OCTINOXATE and OXYBENZONE LOTION TOPICAL 20130924 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OXYBENZONE 3600; 1800 mg/50mL; mg/50mL 67938-0732_0f754894-4e0b-453b-b1fa-6af0e7e8db5a 67938-0732 HUMAN OTC DRUG Ceramide Time Complex Moisture Cream SPF 15 Octinoxate CREAM TOPICAL 20070327 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 3 g/50g 67938-0772_42873170-b324-4670-a0c9-8b2baeba044f 67938-0772 HUMAN OTC DRUG Ceramide EyeWish Eye Sunscreen SPF 10 OCTINOXATE and OXYBENZONE CREAM TOPICAL 20060316 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OXYBENZONE .852; .071 g/14.2g; g/14.2g 67938-0774_1eef0736-09fc-40de-b8c0-a745842f4ea6 67938-0774 HUMAN OTC DRUG Eight Hour Cream Lip Protectant SPF 15 Petrolatum STICK TOPICAL 20060531 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OXYBENZONE; PADIMATE O; PETROLATUM .111; .296; 1.12 g/3.7g; g/3.7g; g/3.7g 67938-0801_ae6f4a9b-b4b6-4642-ac04-553fbd0571b9 67938-0801 HUMAN OTC DRUG Elizabeth Arden Moisture Shield SPF 15 Octinoxate LOTION TOPICAL 20060626 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE .75; 3.125; 2.5; 1 mL/50mL; mL/50mL; mL/50mL; mL/50mL 67938-0802_d0dedb46-ba65-4bc0-af6e-28a0d80f0778 67938-0802 HUMAN OTC DRUG Ceramide Lift And Firm Day Broad Spectrum Sunscreen SPF 30 OCTINOXATE, OXYBENZONE, OCTISALATE, and AVOBENZONE LOTION TOPICAL 20090227 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 1; 3.75; 2.5; 2.5 g/50g; g/50g; g/50g; g/50g 67938-0808_3f4438b9-4b70-4c46-88b0-8daac18d00a4 67938-0808 HUMAN OTC DRUG Intervene Radiance Boosting Moisture SPF 15 Octinoxate LOTION TOPICAL 20090818 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc AVOBENZONE; OCTINOXATE; OXYBENZONE 1.5; 3.75; 1.5 mL/50mL; mL/50mL; mL/50mL 67938-0821_ab072a1f-93c7-4fb9-bdfa-6e1f7a7358e3 67938-0821 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Ivory Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-0823_bdff6bd1-cd7f-4f41-a2a6-78f36c5ec0b1 67938-0823 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Cream Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-0824_bcd7ff5d-04e1-4e91-ab12-57d4d3d1e325 67938-0824 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Cameo Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-0825_ae7eb263-735f-4526-80b9-3741e750c8dd 67938-0825 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Bisque Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-0826_87b3ccaf-2440-4136-883a-de2a42a613ed 67938-0826 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Buff Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-0827_8eaa327b-5393-4bb9-8dd4-c6092f755586 67938-0827 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Honey Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-0828_1a2c11d0-4343-43d8-896b-e963b37ed07f 67938-0828 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Fawn Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-0830_a5ec33a9-475f-4c03-a317-84e0be04f11e 67938-0830 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Beige Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-0831_82b419d0-04a2-45f1-9b5a-97d35ea5fecf 67938-0831 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Mocha Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-0834_b0462d94-f054-46e3-b44d-01bac0efc22f 67938-0834 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Camellia Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-0858_023c7728-8edf-480d-a7b0-c95ed8775065 67938-0858 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Toasty Beige Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-0859_271a0451-07d4-4e0d-8a24-439dda4eb863 67938-0859 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Honey Beige Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-0860_b5136a5c-eb17-4cf8-af67-3be426d3d7d9 67938-0860 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Perfect Beige Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-0866_ef12b107-049f-43c9-acaa-552bda7c8fdb 67938-0866 HUMAN OTC DRUG Eight Hour Cream Intensive Daily Moisturizer For Face SPF 15 Octinoxate CREAM TOPICAL 20081006 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc AVOBENZONE; OCTINOXATE; OXYBENZONE .98; 2.94; 1.47 g/49g; g/49g; g/49g 67938-0904_9f69f4f0-b49a-4b08-b3fe-691cf0fa03d3 67938-0904 HUMAN OTC DRUG Prevage Anti Aging Moisture Broad Spectrum Sunscreen SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, and AVOBENZONE LOTION TOPICAL 20090604 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 10; 35; 25; 11; 25 mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL 67938-0906_b096eeb9-8445-4bad-b2d7-a5604456fc5a 67938-0906 HUMAN OTC DRUG Pure Finish Mineral Tinted Moisturizer SPF 15 Fair Octinoxate LOTION TOPICAL 20100726 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3; 2; 2.15 mL/50mL; mL/50mL; mL/50mL 67938-0907_2bb58a3e-805d-4a3a-8be7-0857fca1e68a 67938-0907 HUMAN OTC DRUG Pure Finish Mineral Tinted Moisturizer SPF 15 Light Octinoxate LOTION TOPICAL 20100726 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3; 2; 2.15 mL/50mL; mL/50mL; mL/50mL 67938-0908_d153c6d4-5408-4c0a-9ab3-5371220bc93c 67938-0908 HUMAN OTC DRUG Pure Finish Mineral Tinted Moisturizer SPF 15 Medium Octinoxate LOTION TOPICAL 20100726 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3; 2; 2.15 mL/50mL; mL/50mL; mL/50mL 67938-0909_644b092f-9fbf-466c-9471-0e3f2c42d0b5 67938-0909 HUMAN OTC DRUG Pure Finish Mineral Tinted Moisturizer SPF 15 Deep Octinoxate LOTION TOPICAL 20100726 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3; 2; 2.15 mL/50mL; mL/50mL; mL/50mL 67938-091_3d2ed268-8c53-483d-843d-04565252e06d 67938-091 HUMAN OTC DRUG Intervene Makeup SPF 15 Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL 67938-0936_3732eea0-dcd9-46d0-b346-69496fefee21 67938-0936 HUMAN OTC DRUG Ceramide Lift and Firm Makeup Broad Spectrum Sunscreen SPF 15 Ecru OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g 67938-0937_a6ad9680-d3b6-41e7-b632-73c99eddcd5b 67938-0937 HUMAN OTC DRUG Ceramide Lift and Firm Makeup Broad Spectrum Sunscreen SPF 15 Vanilla Shell OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g 67938-0938_48ec1956-3a6f-4f6f-adb6-e9b0050200a5 67938-0938 HUMAN OTC DRUG Ceramide Lift and Firm Makeup Broad Spectrum Sunscreen SPF 15 Warm Sunbeige OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g 67938-0939_5aa6217a-41ce-4a07-8acb-5513d5bd1536 67938-0939 HUMAN OTC DRUG Ceramide Lift And Firm Makeup Broad Sprectrum Sunscreen SPF 15 Sandstone OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g 67938-0940_85e678d5-eeff-41ee-a538-0ccf6e25901b 67938-0940 HUMAN OTC DRUG Ceramide Lift And Firm Makeup Broad Spectrum Sunscreen SPF 15 Cream OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g 67938-0941_16cf7f26-0736-4097-8bf6-c039f812c482 67938-0941 HUMAN OTC DRUG Ceramide Lift And Firm Makeup Broad Spectrum Sunscreen SPF 15 Beige OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g 67938-0942_5965adbc-7815-4d18-83e0-7f9c2d460cbc 67938-0942 HUMAN OTC DRUG Ceramide Lift And Firm Makeup Broad Spectrum Sunscreen SPF 15 Cameo OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g 67938-0943_f1f15c9f-3491-49a7-ab96-7c71e5c16a57 67938-0943 HUMAN OTC DRUG Ceramide Lift And Firm Makeup Broad Spectrum Sunscreen SPF 15 Buff OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g 67938-0944_b636f3d4-5b99-468a-baef-ac6d0341b135 67938-0944 HUMAN OTC DRUG Ceramide Lift And Firm Makeup Broad Spectrum Sunscreen SPF 15 Warm Honey OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g 67938-0945_a46bf143-dc4a-44ca-8a4d-d6f5a20e8ea7 67938-0945 HUMAN OTC DRUG Ceramide Lift And Firm Makeup Broad Spectrum Sunscreen SPF 15 Bisque OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g 67938-0946_b905d989-4041-4292-9b91-fd7e6073dad3 67938-0946 HUMAN OTC DRUG Ceramide Lift And Firm Makeup Broad Spectrum Sunscreen SPF 15 Cognac OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g 67938-0947_fabb9a74-ef89-4b17-86fc-e782f0cab3c1 67938-0947 HUMAN OTC DRUG Ceramide Lift And Firm Makeup Broad Spectrum Sunscreen SPF 15 Toast OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g 67938-0948_b1055291-482f-4e2d-8af2-f489337b849f 67938-0948 HUMAN OTC DRUG Ceramide Lift And Firm Makeup Broad Spectrum Sunscreen SPF 15 Mocha OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g 67938-0949_ad210b46-69b1-4edf-95c4-9230d6165e20 67938-0949 HUMAN OTC DRUG Ceramide Lift And Firm Makeup Broad Spectrum Sunscreen SPF 15 Warm Bronze OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g 67938-0950_73ab9f80-e3ad-4fd0-980f-a163f1b20cda 67938-0950 HUMAN OTC DRUG Ceramide Lift And Firm Makeup Broad Spectrum Sunscreen SPF 15 Cocoa OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g 67938-0951_aa9d1f8a-1d38-49fb-9f80-74dff27163df 67938-0951 HUMAN OTC DRUG Ceramide Lift and Firm Makeup Broad Spectrum Sunscreen SPF 15 Spice OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g 67938-0964_787b5e53-6a3b-4c2d-8387-fed1e9d0e350 67938-0964 HUMAN OTC DRUG Ceramide Lift And Firm Day Broad Spectrum Sunscreen SPF 30 OCTINOXATE, OXYBENZONE, OCTISALATE, OCTOCRYLENE, and AVOBENZONE CREAM TOPICAL 20090227 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .98; 3.675; 2.45; 1.078; 2.45 g/49g; g/49g; g/49g; g/49g; g/49g 67938-0967_588818aa-fbaf-4526-a529-a86215802e29 67938-0967 HUMAN OTC DRUG Ceramide Plump Perfect Lip Moisture SPF 30 Octinoxate CREAM TOPICAL 20040430 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE .4365; 1.091; .7275; .3928 g/14.55g; g/14.55g; g/14.55g; g/14.55g 67938-0990_052fcac6-645a-447f-a693-43991bb4362f 67938-0990 HUMAN OTC DRUG Prevage Anti Agining Triple Defense Shield Broad Spectrum Sunscreen SPF 50 OCTINOXATE, OXYBENZONE, OCTISALATE, OCTOCRYLENE, and AVOBENZONE LOTION TOPICAL 20111214 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 75; 50; 40; 60 mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL 67938-0993_79efd427-1b07-4443-9b13-3665b646ed01 67938-0993 HUMAN OTC DRUG Ceramide Lift And Firm Eye Sunscreen SPF 15 OCTINOXATE and OXYBENZONE CREAM TOPICAL 20100427 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OXYBENZONE .58896; .2016 g/14.4g; g/14.4g 67938-1000_28434e69-3527-4030-bb7a-3f551a30bf9f 67938-1000 HUMAN OTC DRUG VISIBLE DIFFERENCE SKIN BALANCING SUNSCREEN SPF 15 OCTINOXATE and OXYBENZONE LOTION TOPICAL 20111116 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OXYBENZONE 60; 30 mg/50mL; mg/50mL 67938-102_9dff3920-a9a8-4071-9ed2-d96ebae108bd 67938-102 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g 67938-1022_6e9d7251-4f6c-4f94-aaf9-47fcec4d3b52 67938-1022 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Vanilla Shell Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-1023_b07b9ceb-e5b9-41a6-bd88-3401fdaf054f 67938-1023 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Warm Sunbeige Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-1024_0aa1b448-db4c-42f9-870f-6ae910e22d32 67938-1024 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Warm Bronze Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-1025_2613eafe-5cff-4ba0-8ab5-871f34f4ec99 67938-1025 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Warm Cappuccino Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-1026_5f047c47-991a-4a6f-a706-a12ad0856767 67938-1026 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Warm Mahogany Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL 67938-1044_7ea82ff0-45b3-4b0e-9d08-c10873534efa 67938-1044 HUMAN OTC DRUG Intervene Radiance Boosting Moisture SPF 15 Octinoxate CREAM TOPICAL 20090727 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc AVOBENZONE; OCTINOXATE; OXYBENZONE 1.5; 3.75; 1.5 g/50g; g/50g; g/50g 67938-1074_4ef908e8-5754-42bb-8dc3-d807bd5e5348 67938-1074 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Porcelain Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL 67938-1075_bd24d360-ba0f-439c-96bc-29a367fd3dbd 67938-1075 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Shell Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL 67938-1076_b0971fb3-4e62-4cd5-b027-57889a51aba2 67938-1076 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Sunbeige Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL 67938-1077_614e6cb3-f4a1-4e36-bdba-3562e34dbd2c 67938-1077 HUMAN OTC DRUG Intervene Makeup Broad Spectrum Sunscreen SPF 15 Soft Cream OCTINOXATE CREAM TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 g/30g 67938-1078_de160499-21c9-4076-a448-9cd8f4ba4f48 67938-1078 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Sand Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL 67938-1079_ddf42248-de19-4cae-9950-3f94ad63315b 67938-1079 HUMAN OTC DRUG Intervene Makeup Broad Spectrum Sunscreen SPF 15 Soft Cameo OCTINOXATE CREAM TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 g/30g 67938-1080_865912e4-c63e-46e7-9fd7-63b2bc076108 67938-1080 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Beige Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL 67938-1081_a970399e-5c2d-4949-9f4b-699dc69fa61c 67938-1081 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Bisque Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL 67938-1082_87348e8c-b0bf-4f0a-a6b6-9b699b60ce10 67938-1082 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Wheat Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL 67938-1083_bbf219d2-42b9-4113-85f5-ce304a4eb179 67938-1083 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Honey Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL 67938-1084_dd22002f-b58b-4b4b-a195-6d566fc8906c 67938-1084 HUMAN OTC DRUG Intervene Makeup Broad Spectrum Sunscreen SPF 15 Soft Cognac OCTINOXATE CREAM TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 g/30g 67938-1085_038ec972-f4b2-4f5f-a1a7-6764b7a45dad 67938-1085 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Toast Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL 67938-1086_6267433f-0a70-482b-9079-b8aa2b0d4a1a 67938-1086 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Bronze Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL 67938-1087_48ca5384-182b-4a9b-989d-689ed9666591 67938-1087 HUMAN OTC DRUG Intervene Makeup Broad Spectrum Sunscreen SPF 15 Soft Tan OCTINOXATE CREAM TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 g/30g 67938-1088_e5a7e429-a4c6-4bfa-88fb-d2346d42cfe9 67938-1088 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Toffee Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL 67938-1089_2e8d0219-cbcf-4837-a8cb-34ae7b525c7c 67938-1089 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Cocoa Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL 67938-1094_3b8062cc-06a4-496e-8aa5-8fe2a940014d 67938-1094 HUMAN OTC DRUG Eight Hour Cream Sun Defense for Face SPF 50 Sunscreen Zinc Oxide LOTION TOPICAL 20101214 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OCTISALATE; ZINC OXIDE 3.922; 2.65; 6.159 g/53g; g/53g; g/53g 67938-110_aae738b0-8868-4a6a-89b9-01fbb4e7160a 67938-110 HUMAN OTC DRUG Pure Finish Mineral Tinted Moisturizer SPF 15 Octinoxate LOTION TOPICAL 20100726 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3; 2; 2.15 mL/50mL; mL/50mL; mL/50mL 67938-1111_97dab94c-6a46-48c9-9427-68be6eb6e103 67938-1111 HUMAN OTC DRUG Eight Hour Cream Nourishing Lip Balm SPF 20 OCTINOXATE and AVOBENZONE SALVE TOPICAL 20120724 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc AVOBENZONE; OCTINOXATE .426; .568 g/14.2g; g/14.2g 67938-1126_b9134ec2-2e8d-4685-b162-20ede195bf0a 67938-1126 HUMAN OTC DRUG Prevage Anti Aging Eye Sunscreen SPF 15 OCTINOXATE and OXYBENZONE CREAM TOPICAL 20110314 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OXYBENZONE .613; .21 g/15g; g/15g 67938-1130_fa51c66b-22fb-44cc-8a99-b4178c023739 67938-1130 HUMAN OTC DRUG Eight Hour Cream Targeted Sun Defense SPF 50 Homosalate STICK TOPICAL 20100712 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE .14; .51; .51; .34; .27 g/6.8g; g/6.8g; g/6.8g; g/6.8g; g/6.8g 67938-1145_565e6022-cfef-4384-b96c-b5269ae5e711 67938-1145 HUMAN OTC DRUG Ceramide Premier Intense Moisture and Renewal Activation Broad Spectrum SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, and AVOBENZONE CREAM TOPICAL 20111222 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .98; 3.68; 2.45; 1.47; 1.96 g/49g; g/49g; g/49g; g/49g; g/49g 67938-1149_9f78a938-c8af-460d-ae67-e75a5b1f6ad6 67938-1149 HUMAN OTC DRUG EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE PETROLATUM CREAM TOPICAL 20110707 OTC MONOGRAPH FINAL part347 Elizabeth Arden, Inc PETROLATUM 28.4 g/50g 67938-1152_478bdcd5-6ad2-44d1-8fb7-094e573fa951 67938-1152 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Bisque Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE .59; 1.19 g/17g; g/17g 67938-1153_03cd0b1d-835d-4de3-b457-36dab5381d99 67938-1153 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Camellia Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE .59; 1.19 g/17g; g/17g 67938-1154_cf5cf4bd-7b5b-4a5e-a346-6d08164fc4bc 67938-1154 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Sunbeige Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE .59; 1.19 g/17g; g/17g 67938-1156_cd07f964-259f-490f-a993-fe57e141a701 67938-1156 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Golden Beige Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE .59; 1.19 g/17g; g/17g 67938-1157_006ab296-53b0-495a-aa52-f572728485f3 67938-1157 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Vanilla Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE .59; 1.19 g/17g; g/17g 67938-1158_937ecbc9-200a-4887-add5-070aa6dcaf6b 67938-1158 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Cream Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE .59; 1.19 g/17g; g/17g 67938-1159_81d5086a-8be0-4aa8-8354-e44c2dd79d1b 67938-1159 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Cameo Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE .59; 1.19 g/17g; g/17g 67938-1161_2c3a1f37-5d50-43be-8728-9b36ffa62586 67938-1161 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Buff Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE .59; 1.19 g/17g; g/17g 67938-1162_25618c97-46ef-4ddb-91e8-05b83b93e8fd 67938-1162 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Honey Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE .59; 1.19 g/17g; g/17g 67938-1163_6e35f920-aefe-4cad-b3b8-6cd3d149b7e6 67938-1163 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Shell Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE .59; 1.19 g/17g; g/17g 67938-1164_22f4f6ec-ffe3-4c2a-95df-637bbea2da39 67938-1164 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Beige Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE .59; 1.19 g/17g; g/17g 67938-1165_fd591eb9-d3d3-4991-a826-4f813d841bbd 67938-1165 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Mocha Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE .59; 1.19 g/17g; g/17g 67938-1169_9730a816-2019-4dd9-90c2-9fe8320017fd 67938-1169 HUMAN OTC DRUG Visible Difference Gentle Hydrating Broad Spectrum Sunscreen SPF 15 OCTINOXATE, AVOBENZONE, and OXYBENZONE CREAM TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc AVOBENZONE; OCTINOXATE; OXYBENZONE 1.5; 3.75; 1.5 g/50g; g/50g; g/50g 67938-1171_1a853083-a2fd-4f41-9413-4256950634a7 67938-1171 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Ivory Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE .59; 1.19 g/17g; g/17g 67938-1172_b1125143-4906-4c0b-a662-9d781d7ca1f4 67938-1172 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Fawn Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE .59; 1.19 g/17g; g/17g 67938-1390_ad45ffb5-5db6-4712-856a-8b2d9b495d67 67938-1390 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 1 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g 67938-1391_6acb79d2-f096-453f-a3b2-a865d660a369 67938-1391 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 2 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g 67938-1392_cc1b63a0-262e-44d1-a8c1-d2592790e516 67938-1392 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 3 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g 67938-1393_74268960-ce35-405b-954a-838c0a7367f7 67938-1393 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 4 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g 67938-1394_fd135a20-8a9a-4a60-a6d7-36b3dd77cc61 67938-1394 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 5 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g 67938-1395_df3caf7c-01d4-4fcb-b1db-ea0bbd365d12 67938-1395 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 6 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g 67938-1396_b7c0e970-ad29-4b0e-b840-061fd7ca93f2 67938-1396 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 7 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g 67938-1397_9a5fb2ce-fe10-4f20-b62f-4f3869bafb09 67938-1397 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 8 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g 67938-1401_8f1f6012-7e09-4f2d-84b4-1f331a77d829 67938-1401 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 9 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g 67938-1407_3cc368d7-5027-41f3-a078-fcd9e874edf5 67938-1407 HUMAN OTC DRUG Eight Hour Cream Lip Protectant Sheer Tint SPF 15 Honey Petrolatum STICK TOPICAL 20060328 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OXYBENZONE; PADIMATE O; PETROLATUM .111; .296; 1.117 g/3.7g; g/3.7g; g/3.7g 67938-1408_c1dc4abb-217c-4c63-9e38-02b17d42e199 67938-1408 HUMAN OTC DRUG Eight Hour Cream Lip Protectant Sheer Tint SPF 15 Blush Petrolatum STICK TOPICAL 20060328 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OXYBENZONE; PADIMATE O; PETROLATUM .111; .296; 1.117 g/3.7g; g/3.7g; g/3.7g 67938-1409_89ab540c-b3f0-4771-bf9c-613f9aa2e3e0 67938-1409 HUMAN OTC DRUG Eight Hour Cream Lip Protectant Sheer Tint SPF 15 Plum Petrolatum STICK TOPICAL 20060328 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OXYBENZONE; PADIMATE O; PETROLATUM .111; .296; 1.117 g/3.7g; g/3.7g; g/3.7g 67938-1410_b091c953-431d-42d4-a4dd-5c3144705d1f 67938-1410 HUMAN OTC DRUG Eight Hour Cream Lip Protectant Sheer Tint SPF 15 Chestnut Petrolatum STICK TOPICAL 20060328 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OXYBENZONE; PADIMATE O; PETROLATUM .111; .296; 1.117 g/3.7g; g/3.7g; g/3.7g 67938-1435_b14135f7-f575-4d2b-a719-7875c5f0b6a5 67938-1435 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 10 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g 67938-1436_79fa635c-aef0-4e57-84a3-529287035a1e 67938-1436 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 11 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g 67938-1470_e3a8a087-3248-4c3b-9c0c-e92958888a70 67938-1470 HUMAN OTC DRUG Eight Hour Cream Lip Protectant Sheer Tint SPF 15 Melon Petrolatum STICK TOPICAL 20060328 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OXYBENZONE; PADIMATE O; PETROLATUM .111; .296; 1.117 g/3.7g; g/3.7g; g/3.7g 67938-1472_54448ac9-5df9-4b54-8ca9-edb8123f39b5 67938-1472 HUMAN OTC DRUG Eight Hour Cream Lip Protectant Sheer Tint SPF 15 Berry Petrolatum STICK TOPICAL 20060328 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OXYBENZONE; PADIMATE O; PETROLATUM .111; .296; 1.117 g/3.7g; g/3.7g; g/3.7g 67938-2001_6c9bc32a-a84d-4cfb-b56a-80977727a280 67938-2001 HUMAN OTC DRUG EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER DIMETHICONE CREAM TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part310.545 Elizabeth Arden, Inc DIMETHICONE .9 g/45g 67938-2002_ba106598-24ea-4b9e-b6c4-24aeaf7d6ee0 67938-2002 HUMAN OTC DRUG VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 1 OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 2.55; 1.7; 1.02; 1.95 g/34g; g/34g; g/34g; g/34g 67938-2003_2d6c77af-2d61-4834-9af5-6264d44be206 67938-2003 HUMAN OTC DRUG VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 2.55; 1.7; 1.02; 1.95 g/34g; g/34g; g/34g; g/34g 67938-2004_2db8ac12-cc7c-4067-9163-f1254e98cd27 67938-2004 HUMAN OTC DRUG VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 3 OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 2.55; 1.7; 1.02; 1.95 g/34g; g/34g; g/34g; g/34g 67938-2005_7fd98d21-94a0-44c2-8101-cd461bbfc17f 67938-2005 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE LINEN OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2006_49970f06-2837-4c4b-80bd-7a2d8addbba4 67938-2006 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE ALABASTER OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2007_bc30d9f9-6245-4009-b2db-8836023e37d1 67938-2007 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE VANILLA SHELL OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2008_8651bf8a-0bbe-4f8d-8527-d03aeef79fc6 67938-2008 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE CREAM NUDE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2009_b9daf843-0207-496b-bdf7-5695b4499540 67938-2009 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE NATURAL OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2010_fd9481eb-edc6-4a04-a158-f2bfa55c7e11 67938-2010 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE WARM SUNBEIGE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2011_0d66d8a1-541c-4603-ab1d-823f476c146c 67938-2011 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE GOLDEN NUDE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2012_21c853af-7632-4b29-9e74-42319ef654e9 67938-2012 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE CASHMERE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2013_bc2a6fbc-6eca-4686-ac82-7cc3ef662668 67938-2013 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE BUFF OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2014_679d8f20-eeee-4d99-9348-e6c3f755f324 67938-2014 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE TAWNY OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2015_62c6c703-963c-4097-926f-8cf33f8e9c12 67938-2015 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE SOFT BEIGE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2016_499a88f2-e4e4-4659-9042-a89f1a4e4e64 67938-2016 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2017_a940e6a5-1cff-46b0-a4e4-eb166504c9c4 67938-2017 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE BEIGE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2018_f7749993-a38b-416b-9ffb-c917a50d0913 67938-2018 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE CAMEO OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2019_6a5672ce-62d0-45fa-8873-3388baea7a31 67938-2019 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE HONEY BEIGE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2020_eb36f46a-c975-459b-bc0e-6a58c64ea57d 67938-2020 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE TOASTED ALMOND OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2021_f257c3a2-4655-47b9-8b8b-6abf9d791b9d 67938-2021 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE BISQUE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2022_4013b575-afaa-4d26-a0e4-99ff1ab2e82c 67938-2022 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE CASHEW OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2023_07257470-7587-4bbd-af8a-abaf55c0e7c7 67938-2023 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE TOASTY BEIGE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2024_f6474248-5de3-4bb2-b392-dd8baa35f0fe 67938-2024 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE CARAMEL OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2025_8396b4ad-385b-4575-ae91-7428bafe9ba1 67938-2025 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE WARM CAPPUCCINO OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2026_479c5a0d-d029-44e7-9471-2172d05ddb02 67938-2026 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE WARM MAHOGANY OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2027_cedfd055-e137-478d-a327-5287dc10deaa 67938-2027 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE COCOA OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2028_23abfe4c-ee4e-4eea-bbf4-08f5a44ff586 67938-2028 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE SIENNA OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2029_6eace8fc-bad3-4b6c-89fc-843bf1e8fd7e 67938-2029 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE SPICE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2030_30243138-e310-4ab0-bdbb-3175a67e0857 67938-2030 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE CHESTNUT OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg 67938-2050_bd1f6a62-b6e3-45df-a94a-718c927b25db 67938-2050 HUMAN OTC DRUG FLAWLESS FUTURE MOISTURE OCTINOXATE, OCTISALATE, OXYBENZONE AND AVOBENZONE CREAM TOPICAL 20141107 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 1.5; 3.57; 2.375; 2 g/g; g/g; g/g; g/g 67938-9144_4a35d8eb-5ba6-4e63-a407-1522330489c3 67938-9144 HUMAN OTC DRUG Prevage Anti Aging Moisture Broad Spectrum Sunscreen SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, and AVOBENZONE CREAM TOPICAL 20110622 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1; 3.75; 2.5; 1.1; 2.5 g/50g; g/50g; g/50g; g/50g; g/50g 67942-2100_41f2c0d1-4184-4df8-873d-030957094e33 67942-2100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030430 UNAPPROVED MEDICAL GAS VNA Homecare Services OXYGEN 99 L/100L 67979-001_fc591924-62a3-44c6-8d0e-34794296a0a2 67979-001 HUMAN PRESCRIPTION DRUG Valstar valrubicin SOLUTION, CONCENTRATE INTRAVESICAL 19981001 NDA NDA020892 Endo Pharmaceuticals Solutions Inc. VALRUBICIN 40 mg/mL 67979-002_ca69e7e6-e25f-4565-9843-93dbc7346cbe 67979-002 HUMAN PRESCRIPTION DRUG SUPPRELIN LA histrelin acetate IMPLANT SUBCUTANEOUS 20070531 NDA NDA022058 Endo Pharmaceuticals Solutions Inc. HISTRELIN ACETATE 50 mg/1 Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] 67979-500_ca63bdb8-ff1b-464b-a5f8-4231148fd1cd 67979-500 HUMAN PRESCRIPTION DRUG Vantas histrelin acetate IMPLANT SUBCUTANEOUS 20041101 NDA NDA021732 Endo Pharmaceuticals Solutions Inc. HISTRELIN ACETATE 50 mg/1 Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] 67979-501_2a0a0785-20cc-4f5c-884f-9aa7f8ea07ba 67979-501 HUMAN PRESCRIPTION DRUG DELATESTRYL TESTOSTERONE ENANTHATE INJECTION, SOLUTION INTRAMUSCULAR 19531224 NDA NDA009165 Endo Pharmaceuticals Solutions Inc. TESTOSTERONE ENANTHATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 67979-511_3cd75ed2-8ae5-4033-a5de-1d2ca84b858f 67979-511 HUMAN PRESCRIPTION DRUG Aveed testosterone undecanoate INJECTION INTRAMUSCULAR 20140305 NDA NDA022219 Endo Pharmaceuticals Solutions Inc. TESTOSTERONE UNDECANOATE 250 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII 67989-011_54e8282d-592d-4a21-ab01-2da34170792e 67989-011 HUMAN PRESCRIPTION DRUG Nitric Oxide Nitrogen Mix Nitric Oxide Nitrogen Mix GAS RESPIRATORY (INHALATION) 20100501 UNAPPROVED MEDICAL GAS Airgas Specialty Gases NITRIC OXIDE; NITROGEN 5; 955 mL/L; mL/L Vasodilation [PE],Vasodilator [EPC] 67996-938_3ea77080-e488-41ab-8829-92e8e1e089eb 67996-938 HUMAN OTC DRUG Sani-Soft ALCOHOL LOTION TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part333E Select Specialty Products ALCOHOL .7 mL/mL 68001-001_cb116487-adfa-400a-bbb5-08f4cd9204f5 68001-001 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20130320 NDA NDA020064 BluePoint Laboratories NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 68001-002_14088bf3-10b3-486a-a5a0-db814ae7d47a 68001-002 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20130320 NDA NDA016620 BluePoint Laboratories NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 68001-003_14088bf3-10b3-486a-a5a0-db814ae7d47a 68001-003 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20130320 NDA NDA016620 BluePoint Laboratories NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 68001-004_bc0039c6-348e-4fdb-86c3-88c67908dd17 68001-004 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20140422 ANDA ANDA203399 BluePoint Laboratories METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68001-005_a91f119c-9765-4a6f-b636-4470d11dc3d2 68001-005 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 20130802 ANDA ANDA040189 BluePoint Laboratories METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68001-006_5f976844-ef02-4dd1-b73c-d7c21713e6c0 68001-006 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20130724 ANDA ANDA078926 BluePoint Laboratories GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68001-007_5f976844-ef02-4dd1-b73c-d7c21713e6c0 68001-007 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20130724 ANDA ANDA078926 BluePoint Laboratories GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68001-105_86645b38-9b97-4175-9927-9ffff13f2cb3 68001-105 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131008 ANDA ANDA078239 BluePoint Laboratories DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68001-106_86645b38-9b97-4175-9927-9ffff13f2cb3 68001-106 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131008 ANDA ANDA078239 BluePoint Laboratories DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68001-111_924c5a35-4804-4e14-a2fc-2b84d186d257 68001-111 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20131209 ANDA ANDA091269 BluePoint Laboratoires LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68001-112_924c5a35-4804-4e14-a2fc-2b84d186d257 68001-112 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20131209 ANDA ANDA091269 BluePoint Laboratoires LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68001-113_96ea8ff7-2b0f-4b2c-b63d-90dcf1544a61 68001-113 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, EXTENDED RELEASE ORAL 20140213 ANDA ANDA091399 BluePoint Laboratories LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68001-114_96ea8ff7-2b0f-4b2c-b63d-90dcf1544a61 68001-114 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, EXTENDED RELEASE ORAL 20140213 ANDA ANDA091399 BluePoint Laboratories LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68001-115_9cc796e7-77db-4bf9-9eb9-1bebf33476d3 68001-115 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20140224 ANDA ANDA090025 BluePoint Laboratories LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68001-116_9cc796e7-77db-4bf9-9eb9-1bebf33476d3 68001-116 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20140224 ANDA ANDA078154 BluePoint Laboratories LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68001-117_9cc796e7-77db-4bf9-9eb9-1bebf33476d3 68001-117 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20140224 ANDA ANDA078154 BluePoint Laboratories LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68001-118_9cc796e7-77db-4bf9-9eb9-1bebf33476d3 68001-118 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20140224 ANDA ANDA078154 BluePoint Laboratories LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68001-119_c8b8e6d6-8c79-4334-bcb5-0582afa75508 68001-119 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20131125 ANDA ANDA078889 BluePoint Laboratories METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68001-120_c8b8e6d6-8c79-4334-bcb5-0582afa75508 68001-120 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20131125 ANDA ANDA078889 BluePoint Laboratories METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68001-121_4f83142b-e4d1-4ea5-9afc-f757b0fa8b66 68001-121 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140101 ANDA ANDA090617 BluePoint Laboratories METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68001-122_4f83142b-e4d1-4ea5-9afc-f757b0fa8b66 68001-122 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140101 ANDA ANDA090617 BluePoint Laboratories METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68001-129_77404b81-bf77-4765-9869-a380882c7e60 68001-129 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20131223 ANDA ANDA090223 BluePoint Laboratories FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68001-130_0b6c0fdc-2868-45e6-800e-0349f5eee746 68001-130 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20140213 ANDA ANDA078466 BluePoint Laboratories AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68001-131_0b6c0fdc-2868-45e6-800e-0349f5eee746 68001-131 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20140213 ANDA ANDA078466 BluePoint Laboratories AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68001-132_0b6c0fdc-2868-45e6-800e-0349f5eee746 68001-132 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20140213 ANDA ANDA078466 BluePoint Laboratories AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68001-133_0b6c0fdc-2868-45e6-800e-0349f5eee746 68001-133 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20140213 ANDA ANDA078466 BluePoint Laboratories AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68001-134_0b6c0fdc-2868-45e6-800e-0349f5eee746 68001-134 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20140213 ANDA ANDA078466 BluePoint Laboratories AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68001-135_0b6c0fdc-2868-45e6-800e-0349f5eee746 68001-135 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20140213 ANDA ANDA078466 BluePoint Laboratories AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68001-136_9cd37ec6-e568-4b1a-88de-e0fd33965534 68001-136 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20140226 ANDA ANDA077560 BluePoint Laboratories ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 68001-137_9cd37ec6-e568-4b1a-88de-e0fd33965534 68001-137 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20140226 ANDA ANDA077560 BluePoint Laboratories ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 68001-138_9cd37ec6-e568-4b1a-88de-e0fd33965534 68001-138 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20140226 ANDA ANDA077560 BluePoint Laboratories ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 68001-139_9cd37ec6-e568-4b1a-88de-e0fd33965534 68001-139 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20140226 ANDA ANDA077560 BluePoint Laboratories ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 68001-140_719ad307-a7ff-4f8b-ab58-cbd7a61517c0 68001-140 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140101 ANDA ANDA078832 BluePoint Laboratories RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68001-141_719ad307-a7ff-4f8b-ab58-cbd7a61517c0 68001-141 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140101 ANDA ANDA078832 BluePoint Laboratories RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68001-142_719ad307-a7ff-4f8b-ab58-cbd7a61517c0 68001-142 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140101 ANDA ANDA078832 BluePoint Laboratories RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68001-143_719ad307-a7ff-4f8b-ab58-cbd7a61517c0 68001-143 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140101 ANDA ANDA078832 BluePoint Laboratories RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68001-144_9cf8b105-6e4b-485f-9c29-a1e06e671bd8 68001-144 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20131202 20151031 ANDA ANDA202128 BluePoint Laboratories POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68001-150_a056eb8b-04e8-42fb-a4ff-42f017a113cb 68001-150 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20140207 ANDA ANDA065264 BluePoint Laboratories CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68001-151_8d2c4ed7-9a51-4dc4-b914-0b5ef8242de1 68001-151 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20140422 ANDA ANDA077614 BluePoint Laboratories CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68001-152_8d2c4ed7-9a51-4dc4-b914-0b5ef8242de1 68001-152 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20140422 ANDA ANDA077614 BluePoint Laboratories CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68001-153_8d2c4ed7-9a51-4dc4-b914-0b5ef8242de1 68001-153 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20140422 ANDA ANDA077614 BluePoint Laboratories CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68001-154_8d2c4ed7-9a51-4dc4-b914-0b5ef8242de1 68001-154 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20140422 ANDA ANDA077614 BluePoint Laboratories CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68001-155_4f8dce1f-ba62-424f-bdaa-c171a1ebd917 68001-155 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, COATED ORAL 20140101 ANDA ANDA078921 BluePoint Laboratories ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 68001-156_26349216-275e-450e-94b9-73727b66b775 68001-156 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20131125 ANDA ANDA077653 BluePoint Laboratories VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68001-157_26349216-275e-450e-94b9-73727b66b775 68001-157 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20131125 ANDA ANDA077653 BluePoint Laboratories VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68001-158_26349216-275e-450e-94b9-73727b66b775 68001-158 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20131125 ANDA ANDA077653 BluePoint Laboratories VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68001-159_26349216-275e-450e-94b9-73727b66b775 68001-159 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20131125 ANDA ANDA077653 BluePoint Laboratories VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68001-160_26349216-275e-450e-94b9-73727b66b775 68001-160 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20131125 ANDA ANDA077653 BluePoint Laboratories VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68001-161_44cd6d46-fbb9-4836-9426-d8ce2cb6d66d 68001-161 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20140113 ANDA ANDA040596 BluePoint Laboratories PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68001-162_44cd6d46-fbb9-4836-9426-d8ce2cb6d66d 68001-162 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20140113 ANDA ANDA040596 BluePoint Laboratories PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68001-163_44cd6d46-fbb9-4836-9426-d8ce2cb6d66d 68001-163 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20140113 ANDA ANDA040596 BluePoint Laboratories PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68001-171_b286a2f7-3600-414d-b97c-d1f2cdbd2fd0 68001-171 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20140122 ANDA ANDA202323 BluePoint Laboratories CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 68001-172_b286a2f7-3600-414d-b97c-d1f2cdbd2fd0 68001-172 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20140122 ANDA ANDA202323 BluePoint Laboratories CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 68001-176_6d821e04-0643-4000-8ecc-3172f6ef632f 68001-176 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET ORAL 20140204 ANDA ANDA202025 BluePoint Laboratories SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 68001-177_40cd6505-6640-4e0c-92bf-f664a2f113fd 68001-177 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20140226 ANDA ANDA078181 BluePoint Laboratories GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68001-178_40cd6505-6640-4e0c-92bf-f664a2f113fd 68001-178 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20140226 ANDA ANDA078181 BluePoint Laboratories GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68001-179_40cd6505-6640-4e0c-92bf-f664a2f113fd 68001-179 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20140226 ANDA ANDA078181 BluePoint Laboratories GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68001-180_c10c3be3-bbb6-43f2-a6d1-145385543365 68001-180 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20130228 ANDA ANDA201109 BluePoint Laboratories QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 68001-181_c10c3be3-bbb6-43f2-a6d1-145385543365 68001-181 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20130228 ANDA ANDA201109 BluePoint Laboratories QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 68001-182_c10c3be3-bbb6-43f2-a6d1-145385543365 68001-182 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20130228 ANDA ANDA201109 BluePoint Laboratories QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 68001-183_c10c3be3-bbb6-43f2-a6d1-145385543365 68001-183 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20130228 ANDA ANDA201109 BluePoint Laboratories QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 68001-184_c10c3be3-bbb6-43f2-a6d1-145385543365 68001-184 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20130228 ANDA ANDA201109 BluePoint Laboratories QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 68001-185_c10c3be3-bbb6-43f2-a6d1-145385543365 68001-185 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20130228 ANDA ANDA201109 BluePoint Laboratories QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 68001-186_044546db-a563-12f0-e054-00144ff88e88 68001-186 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20140225 20160430 ANDA ANDA077690 BluePoint Laboratories QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68001-187_044546db-a563-12f0-e054-00144ff88e88 68001-187 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20140225 ANDA ANDA077690 BluePoint Laboratories QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68001-188_044546db-a563-12f0-e054-00144ff88e88 68001-188 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20140225 ANDA ANDA077690 BluePoint Laboratories QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68001-189_044546db-a563-12f0-e054-00144ff88e88 68001-189 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20140225 ANDA ANDA077690 BluePoint Laboratories QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68001-195_a98f0040-e8e4-464e-a6fb-1ece98213497 68001-195 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20140206 ANDA ANDA202280 BluePoint Laboratories ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68001-196_a98f0040-e8e4-464e-a6fb-1ece98213497 68001-196 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20140206 ANDA ANDA202280 BluePoint Laboratories ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68001-197_a98f0040-e8e4-464e-a6fb-1ece98213497 68001-197 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20140206 ANDA ANDA202280 BluePoint Laboratories ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68001-198_670da3b2-e93f-4a09-9130-45af3895cbfa 68001-198 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20140207 ANDA ANDA075584 BluePoint Laboratories BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68001-199_670da3b2-e93f-4a09-9130-45af3895cbfa 68001-199 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20140207 ANDA ANDA075584 BluePoint Laboratories BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68001-200_95e1bf64-a2a7-491c-a803-3bd364b3e769 68001-200 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20140224 ANDA ANDA074394 BluePoint Laboratories DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68001-201_95e1bf64-a2a7-491c-a803-3bd364b3e769 68001-201 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20140224 ANDA ANDA074376 BluePoint Laboratories DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68001-202_95e1bf64-a2a7-491c-a803-3bd364b3e769 68001-202 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20140224 ANDA ANDA074376 BluePoint Laboratories DICLOFENAC SODIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68001-204_573b0aad-fb5c-4bf5-8feb-d39ccd7bb49d 68001-204 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20140226 ANDA ANDA075113 BluePoint Laboratories LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68001-205_573b0aad-fb5c-4bf5-8feb-d39ccd7bb49d 68001-205 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20140226 ANDA ANDA075113 BluePoint Laboratories LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68001-206_573b0aad-fb5c-4bf5-8feb-d39ccd7bb49d 68001-206 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20140226 ANDA ANDA075113 BluePoint Laboratories LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68001-207_b4ef3cdc-4e37-4435-94ae-148f8294648c 68001-207 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140204 ANDA ANDA075994 BluePoint Laboratories LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68001-208_b4ef3cdc-4e37-4435-94ae-148f8294648c 68001-208 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 BluePoint Laboratories LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68001-209_b4ef3cdc-4e37-4435-94ae-148f8294648c 68001-209 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140204 ANDA ANDA075994 BluePoint Laboratories LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68001-210_b4ef3cdc-4e37-4435-94ae-148f8294648c 68001-210 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140204 ANDA ANDA075994 BluePoint Laboratories LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68001-211_b4ef3cdc-4e37-4435-94ae-148f8294648c 68001-211 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140205 ANDA ANDA075994 BluePoint Laboratories LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68001-212_b4ef3cdc-4e37-4435-94ae-148f8294648c 68001-212 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140204 ANDA ANDA075994 BluePoint Laboratories LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68001-213_51d1f1be-0da3-4917-8220-adc0ce4a6878 68001-213 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140210 ANDA ANDA075636 BluePoint Laboratories LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68001-214_51d1f1be-0da3-4917-8220-adc0ce4a6878 68001-214 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140210 ANDA ANDA075636 BluePoint Laboratories LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68001-215_8850dc0e-4be0-4688-ab62-0dce9b078594 68001-215 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 20140226 ANDA ANDA072011 BluePoint Laboratories HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68001-216_8850dc0e-4be0-4688-ab62-0dce9b078594 68001-216 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 20140226 ANDA ANDA073281 BluePoint Laboratories HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68001-219_0152dffb-6575-4d15-9d67-019efa6ae5f6 68001-219 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20140205 ANDA ANDA074501 BluePoint Laboratories NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68001-220_0152dffb-6575-4d15-9d67-019efa6ae5f6 68001-220 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20140205 ANDA ANDA074501 BluePoint Laboratories NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68001-221_0152dffb-6575-4d15-9d67-019efa6ae5f6 68001-221 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20140205 ANDA ANDA074501 BluePoint Laboratories NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68001-222_f6b4e8b5-1a45-4ba0-8416-4261b95c2f51 68001-222 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20140206 ANDA ANDA089367 BluePoint Laboratories ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68001-223_f6b4e8b5-1a45-4ba0-8416-4261b95c2f51 68001-223 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20140206 ANDA ANDA086221 BluePoint Laboratories ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68001-224_51d1f1be-0da3-4917-8220-adc0ce4a6878 68001-224 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140210 ANDA ANDA075636 BluePoint Laboratories LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68001-225_f6b4e8b5-1a45-4ba0-8416-4261b95c2f51 68001-225 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20140206 ANDA ANDA086223 BluePoint Laboratories ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68001-226_62f0c1cd-5030-4347-9d80-c2bef26001a5 68001-226 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET, FILM COATED ORAL 20140227 ANDA ANDA200826 BluePoint Laboratories URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 68001-227_62f0c1cd-5030-4347-9d80-c2bef26001a5 68001-227 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET, FILM COATED ORAL 20140227 ANDA ANDA200826 BluePoint Laboratories URSODIOL 500 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 68001-228_1c6c8d9c-619b-4f68-8921-ba365c2afbfd 68001-228 HUMAN PRESCRIPTION DRUG Trospium Chloride Trospium Chloride CAPSULE, EXTENDED RELEASE ORAL 20140311 ANDA ANDA091289 BluePoint Laboratories TROSPIUM CHLORIDE 60 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 68001-229_c550b7bf-50ee-4833-b63f-fed6af068db6 68001-229 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20140313 ANDA ANDA070035 BluePoint Laboratories METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 68001-230_c550b7bf-50ee-4833-b63f-fed6af068db6 68001-230 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20140313 20151231 ANDA ANDA070044 BluePoint Laboratories METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 68001-231_b4276f14-ee47-4931-b8c4-37639eb280af 68001-231 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20140226 ANDA ANDA201089 BluePoint Laboratories DICLOFENAC SODIUM; MISOPROSTOL 50; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 68001-232_b4276f14-ee47-4931-b8c4-37639eb280af 68001-232 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20140226 ANDA ANDA201089 BluePoint Laboratories DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 68001-233_3704c3d1-1cc0-4194-b071-c718ac53ec35 68001-233 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20140227 ANDA ANDA076470 BluePoint Laboratories DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 68001-234_3704c3d1-1cc0-4194-b071-c718ac53ec35 68001-234 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20140227 ANDA ANDA076470 BluePoint Laboratories DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 68001-235_221a887f-6ad1-4868-97f8-0893d29c2450 68001-235 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20140225 ANDA ANDA076368 BluePoint Laboratories POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68001-236_3013dea9-799e-4741-84f9-45df1320d6d9 68001-236 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140224 ANDA ANDA077715 BluePoint Laboratories BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68001-237_1ea412db-d847-4094-be83-e3bd7328537a 68001-237 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20140303 ANDA ANDA070974 BluePoint Laboratories CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68001-238_1ea412db-d847-4094-be83-e3bd7328537a 68001-238 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20140303 ANDA ANDA070975 BluePoint Laboratories CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68001-239_1ea412db-d847-4094-be83-e3bd7328537a 68001-239 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20140303 ANDA ANDA070976 BluePoint Laboratories CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68001-240_61d1a34a-3d08-483b-9861-9f7b2d54bb40 68001-240 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20140407 ANDA ANDA078916 BluePoint Laboratories FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68001-241_61d1a34a-3d08-483b-9861-9f7b2d54bb40 68001-241 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20140407 ANDA ANDA078916 BluePoint Laboratories FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68001-242_59424254-18d0-418f-9480-804d7a59a266 68001-242 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20140313 ANDA ANDA077651 BluePoint Laboratories ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68001-243_59424254-18d0-418f-9480-804d7a59a266 68001-243 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20140313 ANDA ANDA077651 BluePoint Laboratories ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68001-244_59424254-18d0-418f-9480-804d7a59a266 68001-244 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20140313 ANDA ANDA077651 BluePoint Laboratories ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68001-245_989dead5-9b9e-4ce2-b685-cbb6ae57afd3 68001-245 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20140313 ANDA ANDA091211 BluePoint Laboratories ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 68001-246_87f20f04-2da4-435b-b311-67f2e963751f 68001-246 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20140313 ANDA ANDA078152 BluePoint Laboratories ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68001-247_87f20f04-2da4-435b-b311-67f2e963751f 68001-247 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20140313 ANDA ANDA078152 BluePoint Laboratories ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68001-248_fc9bae7b-fff2-43f5-bd35-85974cf93ed0 68001-248 HUMAN PRESCRIPTION DRUG montelukast sodium montelukast sodium TABLET, FILM COATED ORAL 20140313 ANDA ANDA090926 BluePoint Laboratories MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 68001-249_cf8d2ac5-27f1-4cf6-af6b-8d0545d17400 68001-249 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20140313 ANDA ANDA201779 BluePoint Laboratories ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68001-250_cf8d2ac5-27f1-4cf6-af6b-8d0545d17400 68001-250 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20140313 ANDA ANDA201779 BluePoint Laboratories ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68001-251_3fd512c3-126f-49cc-91ef-6767c3312398 68001-251 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140313 ANDA ANDA077253 BluePoint Laboratories FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68001-252_3fd512c3-126f-49cc-91ef-6767c3312398 68001-252 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140313 ANDA ANDA077253 BluePoint Laboratories FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68001-253_3fd512c3-126f-49cc-91ef-6767c3312398 68001-253 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140313 ANDA ANDA077253 BluePoint Laboratories FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68001-254_3fd512c3-126f-49cc-91ef-6767c3312398 68001-254 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140313 ANDA ANDA077253 BluePoint Laboratories FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68001-255_790d68c0-8f23-4c27-add2-02c8abdbb961 68001-255 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140314 ANDA ANDA090739 BluePoint Laboratories DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68001-256_790d68c0-8f23-4c27-add2-02c8abdbb961 68001-256 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140314 ANDA ANDA090739 BluePoint Laboratories DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68001-257_790d68c0-8f23-4c27-add2-02c8abdbb961 68001-257 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140314 ANDA ANDA090739 BluePoint Laboratories DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68001-259_d056a31d-bba9-4bc6-ae32-57fe33e29fd3 68001-259 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20130623 ANDA ANDA202128 BluePoint Laboratories POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68001-260_044546db-a563-12f0-e054-00144ff88e88 68001-260 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20140718 ANDA ANDA077690 BluePoint Laboratories QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68001-263_c550b7bf-50ee-4833-b63f-fed6af068db6 68001-263 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20140924 ANDA ANDA070044 BluePoint Laboratories METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 68001-264_1622e085-a565-4b48-89d5-2fb06a032b75 68001-264 HUMAN PRESCRIPTION DRUG bupropion bupropion TABLET, EXTENDED RELEASE ORAL 20141003 ANDA ANDA201567 BluePoint Laboratories BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68001-265_157d4e0f-806d-4011-9dec-97e2449e507b 68001-265 HUMAN PRESCRIPTION DRUG Etoposide Etoposide INJECTION INTRAVENOUS 20131114 ANDA ANDA074513 BluePoint Laboratories ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] 68001-266_513ca7e7-6867-4f15-b688-6469bb8c82de 68001-266 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20141215 ANDA ANDA040743 BluePoint Laboratories FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 68001-266_d91670fd-7825-4fb9-afc7-a03a595fc70c 68001-266 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20141216 ANDA ANDA040798 BluePoint Laboratories FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 68007-200_6eb2e368-fe0b-4c3a-9bb0-3603c6646813 68007-200 HUMAN OTC DRUG TIANHE GUBEN YAOSHEN TIE GAO MENTHOL PATCH TRANSDERMAL 20100426 OTC MONOGRAPH NOT FINAL part348 GUILIN TIANHE PHARMACEUTICAL CO LTD MENTHOL 3 g/1 68007-201_e564e77f-d241-4a0b-8a5f-4a49a75a74cf 68007-201 HUMAN OTC DRUG TIANHE GUTONG TIEGAO EXTERNAL ANALGESIC PATCH PATCH TRANSDERMAL 20100524 OTC MONOGRAPH NOT FINAL part348 GUILIN TIANHE PHARMACEUTICAL CO LTD CAMPHOR (NATURAL); CAPSAICIN; MENTHOL 3.5; .25; 3.05 g/1; g/1; g/1 68007-202_fb358e32-8e4d-4041-8cf6-e07425c14706 68007-202 HUMAN OTC DRUG TIANHE GUTONG TIEGAO (IN POLYISOBUTYLENE CARRIER) EXTERNAL ANALGESIC PATCH PATCH TRANSDERMAL 20100524 OTC MONOGRAPH NOT FINAL part348 GUILIN TIANHE PHARMACEUTICAL CO LTD CAMPHOR (NATURAL); CAPSAICIN; MENTHOL 4; .25; 3.05 g/1; g/1; g/1 68007-203_d61ccc5c-3720-4bfe-a92a-259e08939a88 68007-203 HUMAN OTC DRUG TIANHE ZHUANGGU GAO PAIN RELIEVING PLASTER PLASTER TRANSDERMAL 20100525 OTC MONOGRAPH NOT FINAL part348 GUILIN TIANHE PHARMACEUTICAL CO LTD CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 3.22; 1.39; 15.01 g/1; g/1; g/1 68007-204_292712a8-5152-442d-8277-f40923fd935f 68007-204 HUMAN OTC DRUG TIANHE ZHUIFENG GAO CAMPHOR, CAPSAICIN AND MENTHOL PLASTER TRANSDERMAL 20100527 OTC MONOGRAPH NOT FINAL part348 GUILIN TIANHE PHARMACEUTICAL CO LTD CAMPHOR (NATURAL); CAPSAICIN; MENTHOL 4.75; .25; 1.4 g/1; g/1; g/1 68012-002_2aefec2f-ed8a-4d4a-90cf-6d3b45680c4b 68012-002 HUMAN PRESCRIPTION DRUG Glumetza metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060801 NDA NDA021748 Santarus, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68012-003_2aefec2f-ed8a-4d4a-90cf-6d3b45680c4b 68012-003 HUMAN PRESCRIPTION DRUG Glumetza metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080617 NDA NDA021748 Santarus, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68012-052_13a61575-ee8c-4a61-aafe-6e85502bff76 68012-052 HUMAN PRESCRIPTION DRUG Zegerid omeprazole, sodium bicarbonate POWDER, FOR SUSPENSION ORAL 20040615 NDA NDA021636 Santarus, Inc. OMEPRAZOLE; SODIUM BICARBONATE 20; 1680 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68012-054_13a61575-ee8c-4a61-aafe-6e85502bff76 68012-054 HUMAN PRESCRIPTION DRUG Zegerid omeprazole, sodium bicarbonate POWDER, FOR SUSPENSION ORAL 20040615 NDA NDA021636 Santarus, Inc. OMEPRAZOLE; SODIUM BICARBONATE 40; 1680 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68012-102_13a61575-ee8c-4a61-aafe-6e85502bff76 68012-102 HUMAN PRESCRIPTION DRUG Zegerid omeprazole, sodium bicarbonate CAPSULE ORAL 20060227 NDA NDA021849 Santarus, Inc. OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68012-104_13a61575-ee8c-4a61-aafe-6e85502bff76 68012-104 HUMAN PRESCRIPTION DRUG Zegerid omeprazole, sodium bicarbonate CAPSULE ORAL 20060227 NDA NDA021849 Santarus, Inc. OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68012-258_70daac32-1a32-4f09-b698-b37f7751dfbd 68012-258 HUMAN PRESCRIPTION DRUG CYCLOSET bromocriptine mesylate TABLET ORAL 20101115 NDA NDA020866 Santarus, Inc. BROMOCRIPTINE MESYLATE .8 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 68012-309_97510ba6-8ede-4703-a011-7bcf3d09b61f 68012-309 HUMAN PRESCRIPTION DRUG Uceris budesonide TABLET, EXTENDED RELEASE ORAL 20130114 NDA NDA203634 Santarus, Inc. BUDESONIDE 9 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68012-350_2aec6843-07b1-4b87-b7a4-ba6ea0711d52 68012-350 HUMAN PRESCRIPTION DRUG Ruconest c1 esterase inhibitor recombinant INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140922 BLA BLA125495 Santarus, Inc. CONESTAT ALFA 2100 U/1 68012-490_c249d29e-ed1d-4e8e-999e-409cc541576c 68012-490 HUMAN PRESCRIPTION DRUG Fenoglide fenofibrate TABLET ORAL 20101118 NDA NDA022118 Santarus, Inc. FENOFIBRATE 40 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68012-495_c249d29e-ed1d-4e8e-999e-409cc541576c 68012-495 HUMAN PRESCRIPTION DRUG Fenoglide fenofibrate TABLET ORAL 20101118 NDA NDA022118 Santarus, Inc. FENOFIBRATE 120 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68016-002_111d0e65-49de-4bd9-9ae7-ac047f9fe313 68016-002 HUMAN OTC DRUG Stool Softener with Laxative Docusate sodium and Sennosides TABLET ORAL 20100708 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC (Premier Value) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 68016-004_af25e84a-1da4-47c9-a8fc-be6b9c6ab6f8 68016-004 HUMAN OTC DRUG Antacid Antigas Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part331 Premier Value ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 68016-005_5c169066-20ad-4b96-88f8-59da57e4684b 68016-005 HUMAN OTC DRUG Premier Value Cavity Protection Mint SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20030908 OTC MONOGRAPH FINAL part355 Premier Value SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 68016-006_d9a640aa-f42c-4c42-ae0d-ccf69cd8663b 68016-006 HUMAN OTC DRUG Hair Regrowth Treatment for Women Minoxidil SOLUTION TOPICAL 20000101 ANDA ANDA074588 Premier Value MINOXIDIL 2 g/100mL 68016-008_d93df710-c5c7-4807-bdc2-4cbccb1518b5 68016-008 HUMAN OTC DRUG Premier Value Famotidine Famotidine TABLET, FILM COATED ORAL 20100723 ANDA ANDA090283 Premier Value FAMOTIDINE 20 mg/1 68016-009_fe334d32-c3ae-42f2-b79f-a3fe823b0e92 68016-009 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone OINTMENT TOPICAL 20060908 OTC MONOGRAPH NOT FINAL part348 Premier Value HYDROCORTISONE 1 g/100g 68016-010_d93df710-c5c7-4807-bdc2-4cbccb1518b5 68016-010 HUMAN OTC DRUG Premier Value Famotidine Famotidine TABLET, FILM COATED ORAL 20100625 ANDA ANDA090283 Premier Value FAMOTIDINE 10 mg/1 68016-011_61a9c394-22f6-4c7c-964c-3235012301de 68016-011 HUMAN OTC DRUG Lice Treatment permethrin LOTION TOPICAL 20050308 ANDA ANDA075014 Premier Value PERMETHRIN 1 mg/100mL 68016-012_766687c8-3394-467a-a95e-31521899a69f 68016-012 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20110421 OTC MONOGRAPH NOT FINAL part333A Chain Drug Consortium, LLC ISOPROPYL ALCOHOL 1.4 mL/1 68016-013_2089e3cb-5fe8-4aec-a5c9-3d0aea4ec941 68016-013 HUMAN OTC DRUG povidine iodine povidine iodine SOLUTION TOPICAL 20110317 OTC MONOGRAPH FINAL part333C Chain Drug Consortium, LLC POVIDONE-IODINE 10 mL/100mL 68016-014_4eedcf7f-412d-4d50-b50e-48b9fd4c6a1c 68016-014 HUMAN OTC DRUG PREMIER VALUE TOLNAFTATE ANTIFUNGAL TOLNAFTATE CREAM TOPICAL 20120120 OTC MONOGRAPH FINAL part333C CHAIN DRUG CONSORTIUM, LLC TOLNAFTATE 10 mg/g 68016-016_98be0564-53f0-4bd6-b1ed-4cee7b0b2df5 68016-016 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090813 OTC MONOGRAPH FINAL part335 Premier Value BISMUTH SUBSALICYLATE 262 mg/15mL 68016-018_5e1a7b93-dc36-424e-b8db-d5c2bc84f508 68016-018 HUMAN OTC DRUG Tussin DM COUGH SUPPRESSANT/EXPECTORANT DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20120901 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 68016-018_e0fad907-2a44-4790-a182-e7c41dca8cc7 68016-018 HUMAN OTC DRUG Tussin DM Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20100108 OTC MONOGRAPH FINAL part341 Premier Value DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 68016-019_d1aaab91-6cbe-4cee-bb2f-de8d4e311921 68016-019 HUMAN OTC DRUG Premier Value Chest Congestion Relief Guaifenesin TABLET ORAL 20090504 OTC MONOGRAPH FINAL part341 Premier Value GUAIFENESIN 400 mg/1 68016-020_4e1b822a-7207-4c59-bb85-ad4db9754b39 68016-020 HUMAN OTC DRUG Tussin EXPECTORANT GUAIFENESIN LIQUID ORAL 20120907 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC GUAIFENESIN 100 mg/5mL 68016-021_8172b221-6e78-4ace-b255-502318e30b75 68016-021 HUMAN OTC DRUG Premier Value Chest and Sinus Congestion relief Guaifenesin/phenylephrine TABLET ORAL 20060201 OTC MONOGRAPH FINAL part341 Premier Value GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 68016-022_ca523028-2349-4201-a3ff-7ba4d4b00050 68016-022 HUMAN OTC DRUG Complete Allergy Medicine Diphenhydramine HCl CAPSULE ORAL 20110323 OTC MONOGRAPH FINAL part336 Chain Drug Consortium, LLC (Premier Value) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 68016-023_82a61a5f-5cb3-4b5e-b039-345d5fd46478 68016-023 HUMAN OTC DRUG Childrens Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Chain Drug Consortium, LLC (Premier Value) CETIRIZINE HYDROCHLORIDE 5 mg/5mL 68016-024_19a92cfe-b417-4d1c-95b3-9a33642854fa 68016-024 HUMAN OTC DRUG Peptic Relief Maximum Strength BISMUTH SUBSALICYLATE SUSPENSION ORAL 20090708 OTC MONOGRAPH FINAL part341 Premier Value BISMUTH SUBSALICYLATE 525 mg/15mL 68016-025_2ba3b3c2-622d-4d35-908d-9564a372242c 68016-025 HUMAN OTC DRUG Childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20120924 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 68016-026_1e92cbc2-8ec7-442e-a6ec-d069080c53fd 68016-026 HUMAN OTC DRUG Adult Long Lasting-Cough Relief Dextromethorphan HBr,USP CAPSULE ORAL 20130522 OTC MONOGRAPH FINAL part341 Chain Drug Consortium LLC DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 68016-027_336b9ad8-cb28-4648-afad-2a8f6da923d0 68016-027 HUMAN OTC DRUG Vitamin A D Petrolatum OINTMENT TOPICAL 20100511 OTC MONOGRAPH FINAL part347 Chain Drug Consortium, LLC PETROLATUM .76 g/g 68016-029_05e11584-1877-0207-e054-00144ff88e88 68016-029 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET, COATED ORAL 20070901 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium, LLC ACETAMINOPHEN 500 mg/1 68016-030_17331594-e332-4ada-9b6b-3805d92f0e98 68016-030 HUMAN OTC DRUG Ibuprofen Pain reliever/ Fever Reducer Ibuprofen 200 mg TABLET ORAL 20141230 ANDA ANDA019355 Chain Drug Consortium IBUPROFEN 200 mg/1 68016-035_099e9bb6-439f-406c-bf5f-1b09028e23ab 68016-035 HUMAN OTC DRUG Antifungal Clotrimazole clotrimazole CREAM TOPICAL 20030911 OTC MONOGRAPH FINAL part333C Premier Value CLOTRIMAZOLE 10 mg/g 68016-045_38879eff-947e-4d34-879c-98ba61cfdc67 68016-045 HUMAN OTC DRUG Aspirin Enteric Coated Regular Strength Aspirin TABLET ORAL 20141027 OTC MONOGRAPH FINAL part343 Chain Drug Consortium ASPIRIN 325 mg/1 68016-050_9deb0741-ce9e-4ade-91f1-6805999a5e6d 68016-050 HUMAN OTC DRUG Antacid Antigas Maximum Strength Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part331 Premier Value ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 400; 40; 400 mg/5mL; mg/5mL; mg/5mL 68016-059_11748a92-d3ea-49eb-bb72-8bc856a715dd 68016-059 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20141104 ANDA ANDA079129 Chain Drug Consortium IBUPROFEN 200 mg/1 68016-063_1292049d-3d33-486d-8bf7-e413d7efac73 68016-063 HUMAN OTC DRUG Premier Value Hydrocortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Chain Drug Consortium HYDROCORTISONE 1 g/100g 68016-065_a0ade520-248d-4d51-8099-3be7716e8203 68016-065 HUMAN OTC DRUG Ibuprofen Caplet Ibuprofen CAPSULE ORAL 20141104 ANDA ANDA079129 Chain Drug Consortium IBUPROFEN 200 mg/1 68016-069_5bd06420-06ab-46ae-9705-d40d3521606b 68016-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 20090112 OTC MONOGRAPH FINAL part347 Chain Drug Consortium PETROLATUM 1 g/g 68016-070_9ac52f1f-0eb8-4264-bd43-0689165e069d 68016-070 HUMAN OTC DRUG Premier Value Miconazole 3 Miconazole Nitrate CREAM VAGINAL 20050302 ANDA ANDA076773 Chain Drug Consortium MICONAZOLE NITRATE 40 mg/g 68016-072_5d35c185-11aa-4ead-8f58-aeeb19487451 68016-072 HUMAN OTC DRUG Night Time Cherry DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20090825 OTC MONOGRAPH FINAL part341 Premier Value DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 135 mg/15mL; mg/5mL 68016-073_1f147b23-b340-4ba7-9455-da43bd3eecdf 68016-073 HUMAN OTC DRUG Miconazole 7 miconazole nitrate CREAM VAGINAL 20030911 ANDA ANDA074164 Premier Value MICONAZOLE NITRATE 2 g/100g 68016-075_b9a1ccee-d10e-48f0-82a5-9898a6dc288e 68016-075 HUMAN OTC DRUG Premier Value Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Chain Drug Consortium BACITRACIN ZINC 500 [iU]/g 68016-076_b832f9e3-8841-4352-9dd4-2eba2505d46b 68016-076 HUMAN OTC DRUG Premier Value Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Chain Drug Consortium NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g 68016-078_0b838bfa-d39a-4c31-b113-f1b95878fe7a 68016-078 HUMAN OTC DRUG Milk of Magnesia Original Magnesium Hydroxide SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part334 Premier Value MAGNESIUM HYDROXIDE 1200 mg/15mL 68016-078_f89af977-fb1e-4df6-bbc5-d2a9588d312d 68016-078 HUMAN OTC DRUG Milk of Magnesia Original Magnesium Hydroxide SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part334 Premier Value MAGNESIUM HYDROXIDE 1200 mg/15mL 68016-080_da5d518e-300c-472c-b8e0-b2f8fb4eb3e7 68016-080 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Chain Drug Constortium TERBINAFINE HYDROCHLORIDE 1 g/100g 68016-081_cb5c72db-ffe0-418e-b885-3e86dcc42604 68016-081 HUMAN OTC DRUG Milk of Magnesia Mint Magnesium Hydroxide SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part334 Premier Value MAGNESIUM HYDROXIDE 1200 mg/15mL 68016-081_f082a0c7-3fcd-47fa-b232-de2a03298f43 68016-081 HUMAN OTC DRUG Milk of Magnesia Mint Magnesium Hydroxide SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part334 Premier Value MAGNESIUM HYDROXIDE 1200 mg/15mL 68016-085_c25f5945-5bef-4b8f-aeca-7f8d976ee08f 68016-085 HUMAN OTC DRUG Premier Value Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Chain Drug Constortium LORATADINE 5 mg/5mL 68016-089_c80f9197-3cc0-40c5-a1c7-d0ef653c5efe 68016-089 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin TABLET, DELAYED RELEASE ORAL 20110322 OTC MONOGRAPH FINAL part343 Chain Drug Consortium, LLC (Premier Value) ASPIRIN 81 mg/1 68016-098_6b95bf05-c5d0-44a2-88ea-ef77a6bfdb33 68016-098 HUMAN OTC DRUG Tussin Long Acting Cough Dextromethorphan HBr LIQUID ORAL 20130129 OTC MONOGRAPH FINAL part341 Premier Value (Chain Drug Consortium, LLC) DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL 68016-099_d8e0161e-c1f3-444a-9d20-0795a2da9fa4 68016-099 HUMAN OTC DRUG Premier Value Hydrocortisone Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Chain Drug Consortium HYDROCORTISONE 1 g/100g 68016-100_e288ca41-a79d-40c0-bb11-5ad8b56d7f1f 68016-100 HUMAN OTC DRUG Tussin Sugar Free Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20090209 OTC MONOGRAPH FINAL part341 Premier Value DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 68016-101_ea86dc55-6109-4d93-9e53-5fdeb20ed5fb 68016-101 HUMAN OTC DRUG Night time sinus Acetaminophen, Doxylamine succinate, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20100713 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC (Premier Value) ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 68016-102_1d5ba76a-2623-4792-aa80-4fc46e4af329 68016-102 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20060908 OTC MONOGRAPH NOT FINAL part348 Premier Value HYDROCORTISONE 1 g/100g 68016-103_7b9c817f-91d9-4bbb-b805-44dc4ffd452c 68016-103 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen LIQUID ORAL 20141003 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium (Premier Value) ACETAMINOPHEN 160 mg/5mL 68016-104_197bf99f-a28e-4520-a011-4ad16b1117bf 68016-104 HUMAN OTC DRUG Milk of Magnesia Wild Cherry MAGNESIUM HYDROXIDE SUSPENSION ORAL 20100108 OTC MONOGRAPH FINAL part334 Premier Value MAGNESIUM HYDROXIDE 1200 mg/15mL 68016-104_b1e6d570-46fa-47bd-b352-95294f341a2f 68016-104 HUMAN OTC DRUG Milk of Magnesia Wild Cherry MAGNESIUM HYDROXIDE SUSPENSION ORAL 20100108 OTC MONOGRAPH FINAL part334 Premier Value MAGNESIUM HYDROXIDE 1200 mg/15mL 68016-106_a1f265ee-1502-403e-9947-d08dbe4054e6 68016-106 HUMAN OTC DRUG Childrens Cetirzine Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Chain Drug Consortium CETIRIZINE HYDROCHLORIDE 5 mg/5mL 68016-109_0707409f-91e0-22b1-e054-00144ff8d46c 68016-109 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20051101 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC DOCUSATE SODIUM 100 mg/1 68016-110_07097099-a2e9-4b8d-e054-00144ff88e88 68016-110 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen, Aspirin, Caffeine TABLET, COATED ORAL 20080401 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium, LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 68016-111_3df3538a-4bf4-4410-b64e-f41e5c348c03 68016-111 HUMAN OTC DRUG Gas Relief SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100719 OTC MONOGRAPH FINAL part332 Chain Drug Consortium, LLC (Premier Value) DIMETHICONE 125 mg/1 68016-112_7570c75f-def2-420a-91e4-d447eb7e8188 68016-112 HUMAN OTC DRUG Premier Value Antibacterial Hand sanitizingenriched with ALO enriched with ALOE VERA BENZALKONIUM CHLORIDE CLOTH TOPICAL 20130716 OTC MONOGRAPH NOT FINAL part333A Premier Value (Chain Drug Consortium, LLC) BENZALKONIUM CHLORIDE .13 g/100g 68016-113_0050c01b-a3d2-4a1a-9f8a-1c280195c438 68016-113 HUMAN OTC DRUG Night Time Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20100413 OTC MONOGRAPH FINAL part341 Premier Value ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 68016-115_6306b5be-b433-43aa-affb-d476b8b9c2c9 68016-115 HUMAN OTC DRUG Premier Value Medicated Chest Rub Camphor Eucalyptus Menthol OINTMENT TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part348 Chain Drug Consortium CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 g/100g; g/100g; g/100g 68016-116_f3d6cd7f-f1c1-4b98-ac22-04bca6c0864d 68016-116 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100708 ANDA ANDA078682 Premier Value (Chain Drug Consortium, LLC) IBUPROFEN 200 mg/1 68016-117_7048935f-40c4-4c9e-96e3-793453c8420d 68016-117 HUMAN OTC DRUG Senna SENNOSIDES TABLET ORAL 20110418 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC (Premier Value) SENNOSIDES 8.6 mg/1 68016-119_2f87982e-06cf-4ad8-bb64-812481010f95 68016-119 HUMAN OTC DRUG Fexofenadine HCl Fexofenadine HCl TABLET ORAL 20120618 ANDA ANDA079112 Chain Drug Consortium, LLC (Premier Value) FEXOFENADINE HYDROCHLORIDE 180 mg/1 68016-123_7367d376-3c77-4df6-b88a-5f0cf1591847 68016-123 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Premier Value LOPERAMIDE HYDROCHLORIDE 2 mg/1 68016-125_8a41f37f-954c-4099-b02f-b424d554caa8 68016-125 HUMAN OTC DRUG Premier Value Infants Ibuprofen concetrated ibuprofen SUSPENSION ORAL 20091201 ANDA ANDA079058 Premier Value IBUPROFEN 50 mg/1.25mL 68016-126_7bbc3ce2-1ce5-415b-8e88-495b95f2a75a 68016-126 HUMAN OTC DRUG Tussin CF DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20120515 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DEXTROMETHORPHAN HYDROBROMIDE; 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DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 68016-200_e9d111fe-bec5-4df0-84d5-3feb6f19044f 68016-200 HUMAN OTC DRUG Daytime sinus Non Drowsy Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20121115 OTC MONOGRAPH FINAL part341 Premier Value (Chain Drug Consortium, LLC) ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 68016-201_fe10b59d-20d6-4f32-a12e-dd76125c30dc 68016-201 HUMAN OTC DRUG Nighttime Sinus Multi symptom Acetaminophen, Doxylamine succinate and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20121018 OTC MONOGRAPH FINAL part341 Premier Value (Chain Drug Consortium, LLC) ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 68016-202_f817e430-d7ed-41a9-908f-4ba9422ffb3f 68016-202 HUMAN OTC DRUG Multi symptom Nighttime cold and flu relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20121115 OTC MONOGRAPH FINAL part341 Premier Value (Chain Drug Consortium, LLC) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 68016-203_f707a548-afc2-43ec-a366-81b4f5594db2 68016-203 HUMAN OTC DRUG DayTime Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20121115 OTC MONOGRAPH FINAL part341 Premier Value (Chain Drug Consortium, LLC) 68016-204_17637d49-c602-4c91-891d-83e13d5f21a8 68016-204 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Premier Value PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 68016-206_c4691af0-db4b-4cc0-8fc1-784a2bb96f9b 68016-206 HUMAN OTC DRUG Senna S Stool Softener with Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20130308 OTC MONOGRAPH NOT FINAL part334 Premier Value (Chain Drug Consortium, LLC) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 68016-210_083a52a8-22fe-43fb-9c8c-02b730358546 68016-210 HUMAN OTC DRUG ultra strength gas relief Simethicone CAPSULE, LIQUID FILLED ORAL 20100708 OTC MONOGRAPH FINAL part332 Premier Value (Chain Drug Consortium, LLC) DIMETHICONE 180 mg/1 68016-213_8f3932e0-7f94-488f-a51b-0fbbc34f8e4e 68016-213 HUMAN OTC DRUG Premier Value Daily Facial Moisturizer Avobenzone, Octocrylene CREAM TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Chain Drug Consortium, LLC AVOBENZONE; OCTOCRYLENE 3; 10 g/100mL; g/100mL 68016-216_d58330fe-2106-4f3d-abd5-8f25bf511e23 68016-216 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20121231 OTC MONOGRAPH NOT FINAL part334 Premier Value (Chain Drug Consortium, LLC) SENNOSIDES 25 mg/1 68016-217_ffb26b7b-ffc7-467a-b54e-5098fa38f62e 68016-217 HUMAN OTC DRUG Ibuprofen and Diphenhydramine HCl IBUPROFEN, DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED ORAL 20130104 ANDA ANDA090397 Premier Value (Chain Drug Consortium, LLC) DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25; 200 mg/1; mg/1 68016-221_6f328004-04d9-44c4-9d1c-d0e0401d0dbc 68016-221 HUMAN OTC DRUG Severe Congestion and Cough MAX Maxium Strength DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20130101 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL 68016-222_3d12cfdb-3cd0-44be-8816-0062d6a9a42e 68016-222 HUMAN OTC DRUG DM MAX Maxium Strength DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20130101 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL 68016-224_7c8f6aa5-051e-413c-97e1-480a66e7b0cd 68016-224 HUMAN OTC DRUG Childrens Cold, Cough and Sore Throat ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL LIQUID ORAL 20130101 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL 68016-227_b7a8d658-657b-48f2-85fb-3dcec0a6f5a2 68016-227 HUMAN OTC DRUG Complete Allergy Antihistamine Diphenhydramine HCl TABLET ORAL 20100713 OTC MONOGRAPH FINAL part336 Premier Value (Chain Drug Consortium, LLC) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 68016-233_bb3c6517-982d-4006-bae2-09151abe9be1 68016-233 HUMAN OTC DRUG Cold and Allergy Phenylephrine HCl and Chlorpheniramine maleate TABLET ORAL 20141229 OTC MONOGRAPH FINAL part341 Chain Drug Consortium CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 68016-235_696ae801-7817-4e6f-b750-2b27ab12c65d 68016-235 HUMAN OTC DRUG Nasal Decongestant Phenylephrine HCl TABLET ORAL 20100712 OTC MONOGRAPH FINAL part341 Premier Value (Chain Drug Consortium, LLC) PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 68016-246_8d72814c-5630-4bb6-a79f-43949bf844c5 68016-246 HUMAN OTC DRUG Pain Relief Regular Strength Acetaminophen TABLET ORAL 20141119 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium ACETAMINOPHEN 325 mg/1 68016-250_fd189157-b213-4146-921f-575feeb1458b 68016-250 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20121206 ANDA ANDA074916 Premier Value IBUPROFEN 100 mg/5mL 68016-252_3dbd86db-de04-44c2-a59f-d5faa6de1d80 68016-252 HUMAN OTC DRUG Premier Value Zinc Oxide Zinc Oxide CREAM TOPICAL 20130430 OTC MONOGRAPH FINAL part347 Chain Drug Consortium, LLC ZINC OXIDE 20 g/100g 68016-254_cf2f1559-8ee7-47cb-bc44-f35402594469 68016-254 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130315 OTC MONOGRAPH FINAL part343 Premier Value (Chain Drug Consortium, LLC) ASPIRIN 81 mg/1 68016-255_a615f137-3ba2-4eba-998c-70c8d446bbaa 68016-255 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Premier Value IBUPROFEN 100 mg/5mL 68016-261_a615f137-3ba2-4eba-998c-70c8d446bbaa 68016-261 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Premier Value IBUPROFEN 100 mg/5mL 68016-262_a615f137-3ba2-4eba-998c-70c8d446bbaa 68016-262 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Premier Value IBUPROFEN 100 mg/5mL 68016-263_a615f137-3ba2-4eba-998c-70c8d446bbaa 68016-263 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Premier Value IBUPROFEN 100 mg/5mL 68016-264_890c3981-9dfa-4bb4-9b3c-84ac09d60415 68016-264 HUMAN OTC DRUG Non-Aspirin PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130315 OTC MONOGRAPH FINAL part341 Premier Value (Chain Drug Consortium, LLC) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 68016-277_6283953c-b181-46c2-afa1-cdbb2c090445 68016-277 HUMAN OTC DRUG Complete Allergy Medicine Diphenhydramine HCl CAPSULE ORAL 20110323 OTC MONOGRAPH FINAL part336 Premier Value (Chain Drug Consortium, LLC) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 68016-278_76b57c55-ea43-4e20-82d5-80e9023f68e0 68016-278 HUMAN OTC DRUG Senna Natural Vegetable Laxative SENNOSIDES TABLET ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 Premier Value (Chain Drug Consortium, LLC) SENNOSIDES 8.6 mg/1 68016-279_425642e3-c255-4122-985e-1b1c5203ac50 68016-279 HUMAN OTC DRUG All Day Allergy Antihistamine Cetirizine Hydrochloride CAPSULE ORAL 20130601 NDA NDA022429 Premier Value (Chain Drug Consortium, LLC) CETIRIZINE HYDROCHLORIDE 10 mg/1 68016-280_bbd9863b-92ed-4e46-b355-99f12c39e8c5 68016-280 HUMAN OTC DRUG Nicotine Polacrilex, Coated Mint Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20130701 ANDA ANDA076569 Premier Value NICOTINE 2 mg/1 68016-281_bbd9863b-92ed-4e46-b355-99f12c39e8c5 68016-281 HUMAN OTC DRUG Nicotine Polacrilex, Coated Mint Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20130601 ANDA ANDA076568 Premier Value NICOTINE 4 mg/1 68016-282_218199aa-9b6e-4f8a-936a-c1e01c9d045f 68016-282 HUMAN OTC DRUG Nicotine Polacrilex, Original Nicotine Polacrilex GUM, CHEWING BUCCAL 20130901 ANDA ANDA074507 Premier Value NICOTINE 2 mg/1 68016-283_218199aa-9b6e-4f8a-936a-c1e01c9d045f 68016-283 HUMAN OTC DRUG Nicotine Polacrilex, Original Nicotine Polacrilex GUM, CHEWING BUCCAL 20130701 ANDA ANDA074507 Premier Value NICOTINE 4 mg/1 68016-284_bbd9863b-92ed-4e46-b355-99f12c39e8c5 68016-284 HUMAN OTC DRUG Nicotine Polacrilex, Coated Mint Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20130601 ANDA ANDA076569 Premier Value NICOTINE 2 mg/1 68016-285_bbd9863b-92ed-4e46-b355-99f12c39e8c5 68016-285 HUMAN OTC DRUG Nicotine Polacrilex, Coated Mint Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20130901 ANDA ANDA076568 Premier Value NICOTINE 4 mg/1 68016-286_218199aa-9b6e-4f8a-936a-c1e01c9d045f 68016-286 HUMAN OTC DRUG Nicotine Polacrilex, Original Nicotine Polacrilex GUM, CHEWING BUCCAL 20130701 ANDA ANDA074507 Premier Value NICOTINE 2 mg/1 68016-287_218199aa-9b6e-4f8a-936a-c1e01c9d045f 68016-287 HUMAN OTC DRUG Nicotine Polacrilex, Original Nicotine Polacrilex GUM, CHEWING BUCCAL 20130601 ANDA ANDA074507 Premier Value NICOTINE 4 mg/1 68016-288_50e7e379-59d7-470e-8074-951a942c2d5a 68016-288 HUMAN OTC DRUG Nicotine Transdermal System Step 1 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 19991001 ANDA ANDA074612 Premier Value NICOTINE 21 mg/24h 68016-289_50e7e379-59d7-470e-8074-951a942c2d5a 68016-289 HUMAN OTC DRUG Nicotine Transdermal System Step 2 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 19991001 ANDA ANDA074612 Premier Value NICOTINE 14 mg/24h 68016-290_50e7e379-59d7-470e-8074-951a942c2d5a 68016-290 HUMAN OTC DRUG Nicotine Transdermal System Step 3 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 19991001 ANDA ANDA074612 Premier Value NICOTINE 7 mg/24h 68016-291_aa719a8e-e4bd-459d-9f70-972ea588eb4b 68016-291 HUMAN OTC DRUG Miconazole miconazole nitrate CREAM TOPICAL 20090515 OTC MONOGRAPH FINAL part333C Premier Value MICONAZOLE NITRATE 2 g/100g 68016-295_733d3671-2924-49d3-ad1d-c577a441ace8 68016-295 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130507 ANDA ANDA091237 Chain Drug Consortium LLC IBUPROFEN 200 mg/1 68016-298_56ef46ad-1576-4cbf-bc97-99ffd24d6c8b 68016-298 HUMAN OTC DRUG Flu and Sore Throat Relief ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL LIQUID ORAL 20140718 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL 68016-299_f9563898-b7ed-4867-bba6-7803331676a2 68016-299 HUMAN OTC DRUG Cold and Chest Congestion Relief ACETAMINOPHEN, GUAIFENESIN , PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20140718 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium, LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/15mL; mg/15mL; mg/15mL 68016-300_f6dbf93e-dbac-49e2-b63c-e3483f34de4d 68016-300 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20130614 OTC MONOGRAPH NOT FINAL part343 Premier Value (Chain Drug Consortium, LLC) ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 68016-302_d52c0cc9-758f-4f38-98db-eee64023d25c 68016-302 HUMAN OTC DRUG Premier Value Sleep-Aid Diphenhydramine HCL CAPSULE ORAL 20130531 OTC MONOGRAPH FINAL part341 Chain Drug Consortium LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 68016-304_64d70729-bd4e-432e-8eaa-475b83cdc9a0 68016-304 HUMAN OTC DRUG Nasal Decongestant Extra Moisturizing Premier Value 0.05% Oxymetazoline HCl SPRAY NASAL 20141104 OTC MONOGRAPH FINAL part341 Premier Value OXYMETAZOLINE HYDROCHLORIDE .05 mg/mL 68016-307_6e77fa98-7ba8-4f7c-b6bf-1b44f1da65b9 68016-307 HUMAN OTC DRUG Nasal Decongestant Sinus Premier Value Oxymetazoline HCl 0.05% SPRAY NASAL 20141104 OTC MONOGRAPH FINAL part341 Premier Value OXYMETAZOLINE HYDROCHLORIDE .05 mg/mL 68016-308_62807708-efc8-44fc-89f9-0d0a0e30305e 68016-308 HUMAN OTC DRUG No Drip Premier Value Oxymetazoline HCl Nasal Solution SPRAY NASAL 20141104 OTC MONOGRAPH FINAL part341 Premier Value OXYMETAZOLINE HYDROCHLORIDE .05 mg/mL 68016-314_3006a9f8-42d7-449e-917c-7125d615aef5 68016-314 HUMAN OTC DRUG Ultra Fine Mist Premier Value Oxymetazoline HCl Nasal Solution SPRAY NASAL 20141104 OTC MONOGRAPH FINAL part341 Premier Value OXYMETAZOLINE HYDROCHLORIDE .05 mg/mL 68016-316_97f170cb-a6bf-41f0-9aca-60e7feb05ff2 68016-316 HUMAN OTC DRUG Nasal Decongestant Premier Value Oxymetazoline HCl 0.05% SPRAY NASAL 20141104 OTC MONOGRAPH FINAL part341 Premier Value OXYMETAZOLINE HYDROCHLORIDE .05 mg/mL 68016-318_455709b4-a56e-46ca-a681-70ca913a2b64 68016-318 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20030819 OTC MONOGRAPH NOT FINAL part356 Chain Drug Consortium, LLc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 68016-333_d5e7572a-ae59-4bf0-a8e8-3200cea61dbd 68016-333 HUMAN OTC DRUG Premier Value Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Premier Value ACETAMINOPHEN 650 mg/1 68016-336_c5e48cf2-e442-4c06-926f-1a4e135d7fe6 68016-336 HUMAN OTC DRUG Premier Value Arthritis 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Premier Value ACETAMINOPHEN 650 mg/1 68016-340_8e256543-de5d-4e4f-a0b0-792ff5ba7f00 68016-340 HUMAN OTC DRUG Premier Value Arthritis Pain Reliever Acetaminophen TABLET, EXTENDED RELEASE ORAL 20121221 ANDA ANDA078569 Premier Value ACETAMINOPHEN 650 mg/1 68016-351_ddf34e72-a3b2-4904-910c-35c0f8f70858 68016-351 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20120330 ANDA ANDA200536 Premier Value RANITIDINE HYDROCHLORIDE 150 mg/1 68016-352_6f3cdce7-0c98-4b55-b0dc-5b0db835db9b 68016-352 HUMAN OTC DRUG Ranitidine - Acid Reducer Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20120710 ANDA ANDA201745 Premier Value RANITIDINE HYDROCHLORIDE 75 mg/1 68016-353_eb7fc54d-0dd6-4851-b9ab-23709ce16754 68016-353 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20130910 ANDA ANDA090142 Chain Drug Consortium, LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 68016-376_45211b15-b13b-4a19-8d2d-bdc324251eb7 68016-376 HUMAN OTC DRUG Nighttime Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Premier Value (Chain Drug Consortium, LLC) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 68016-378_4c6d99b4-3c12-4b5b-905b-b27db86de9bf 68016-378 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH FINAL part347 Premier Value (Chain Drug Consortium, LLC) DIMETHICONE 125 mg/1 68016-381_66059729-25f2-486f-8018-b93f3436967c 68016-381 HUMAN OTC DRUG Premier Value Antacid and Pain Relief Medicine Aspirin, Citric Acid Monohydrate, and Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20060529 OTC MONOGRAPH FINAL part343 Premier Value ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 68016-382_3ae5d98a-9855-4889-a4c1-5df4c1ddcecc 68016-382 HUMAN OTC DRUG Minoxidil Form Men extra strength Minoxidil SOLUTION TOPICAL 20030911 ANDA ANDA075518 Premier Value MINOXIDIL 50 mg/mL 68016-402_62a24a99-a1cc-4c46-907f-6b6261189a83 68016-402 HUMAN OTC DRUG Ultra Lubricant Eye Drops Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20140110 OTC MONOGRAPH FINAL part349 Premier Value POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL 68016-403_7a680d76-0e7e-4c18-8482-d00dda41057b 68016-403 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140110 ANDA ANDA077958 Premier Value KETOTIFEN FUMARATE .35 mg/mL 68016-404_f56a87a6-9615-42ac-87bb-1ad6e157bf19 68016-404 HUMAN OTC DRUG Lubricant Eye Drops Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20140110 OTC MONOGRAPH FINAL part349 Premier Value POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL 68016-405_bcb9dcda-897b-4320-910f-c49091f416b1 68016-405 HUMAN OTC DRUG Moisturizing Lubricant Eye Drops Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20140110 OTC MONOGRAPH FINAL part349 Premier Value CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL 68016-407_48e07ed1-6cfa-41cf-90a4-f5d949874067 68016-407 HUMAN OTC DRUG Premier Value Cold Sore Treatment Camphor CREAM TOPICAL 20130416 OTC MONOGRAPH NOT FINAL part348 Premier Value BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g 68016-409_97a6cb83-eff3-4cb0-a548-cf26269031ee 68016-409 HUMAN OTC DRUG PREMIER VALUE MEDICATED WIPES WITCH HAZEL CLOTH TOPICAL 20110601 OTC MONOGRAPH FINAL part346 CHAIN DRUG CONSORTIUM, LLC WITCH HAZEL 5 g/1 68016-410_ec9cf647-851b-4a1a-82f0-e1b6caf47d35 68016-410 HUMAN OTC DRUG PREMIER VALUE MEDICATED PADS WITCH HAZEL SOLUTION RECTAL; TOPICAL 20110601 OTC MONOGRAPH FINAL part346 CHAIN DRUG CONSORTIUM, LLC WITCH HAZEL .5 mL/mL 68016-414_e6c5d92d-29f0-4bcd-827c-74174162dbaf 68016-414 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20131009 ANDA ANDA074165 Premier Value CLOTRIMAZOLE 1 g/100g 68016-423_1b3ce34f-aae3-43e6-ad62-1253f7878a77 68016-423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Premier Value IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 68016-430_c53ef4e1-007b-4fd3-ad8e-df6de5d83745 68016-430 HUMAN OTC DRUG Premier Value Hemorrhoidal Hemorrhoidal Rectal Suppositories SUPPOSITORY RECTAL 20141001 OTC MONOGRAPH FINAL part346 Chain Drug Consortium COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 88.44; .25 g/100g; g/100g 68016-440_3308f5b6-ee25-4635-9995-629a68ae0f7a 68016-440 HUMAN OTC DRUG Premier Value Adult Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20141001 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium GLYCERIN 83 g/100g 68016-440_960c5483-f262-4880-948a-427bbe6a172c 68016-440 HUMAN OTC DRUG Premier Value Adult Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20141002 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium GLYCERIN 83 g/100g 68016-440_9b54e7a2-75b4-4fe6-9e05-f02a14bdf3ce 68016-440 HUMAN OTC DRUG Premier Value Adult Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20141002 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium GLYCERIN 83 g/100g 68016-441_1ecabb39-078d-43a3-aa27-10670407b363 68016-441 HUMAN OTC DRUG Premier Value Pediatric Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20141002 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium GLYCERIN 83 g/100g 68016-448_7a6061ad-2683-4a36-ba73-5e184647602d 68016-448 HUMAN OTC DRUG Premier Value Original Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20140127 OTC MONOGRAPH FINAL part349 Chain Drug Consortium, LLC TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL 68016-449_bd295fc2-574d-4eb4-8c10-cc614bdd5b89 68016-449 HUMAN OTC DRUG Premier Value Sterile Eye Drops Dextran 70 Polyethylene Glycol 400 Povidone Tetrahydrozoline HCI SOLUTION/ DROPS OPHTHALMIC 20140123 OTC MONOGRAPH FINAL part349 Chain Drug Consortium, LLC DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .001; .01; .01; .0005 mg/mL; mg/mL; mg/mL; mg/mL 68016-450_b9103c90-5517-4310-80b2-327db9fb6c00 68016-450 HUMAN OTC DRUG Allergy Eye Drops Naphazoline hydrochloride and Pheniramine Maleate SOLUTION/ DROPS OPHTHALMIC 20140110 ANDA ANDA202795 Premier Value NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .25; 3 mg/mL; mg/mL 68016-460_3498fad1-3437-4cef-ad99-4877344d6152 68016-460 HUMAN OTC DRUG Premier Value Bisacodyl Laxative Bisacodyl Suppository SUPPOSITORY RECTAL 20141001 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium BISACODYL 10 mg/2000mg 68016-462_7ec7fc28-b863-4ba1-b7cc-a55ed7053888 68016-462 HUMAN OTC DRUG Naproxen Naproxen Sodium CAPSULE ORAL 20141027 ANDA ANDA090545 Chain Drug Consortium NAPROXEN SODIUM 220 mg/1 68016-464_2fd47996-c0eb-4672-9437-185a34d27e88 68016-464 HUMAN OTC DRUG Naproxen Naproxen Sodium TABLET ORAL 20141027 ANDA ANDA090545 Chain Drug Consortium NAPROXEN SODIUM 220 mg/1 68016-470_b3f0acc3-f623-44a4-a49e-923d41748bdd 68016-470 HUMAN OTC DRUG Day Time Cold non drowsy cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20100712 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC (Premier Value) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 68016-472_ed58d4b5-46c1-44af-9141-f3c541046c76 68016-472 HUMAN OTC DRUG Childrens Allergy Fexofenadine Hydrochloride Fexofenadine Hydrochloride SUSPENSION ORAL 20141219 ANDA ANDA203330 Premier Value FEXOFENADINE HYDROCHLORIDE 30 mg/5mL 68016-490_77dcee0d-0078-4d4e-a4c4-59321d42bcaf 68016-490 HUMAN OTC DRUG Day-Time Night-Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20100712 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC (Premier Value) 68016-500_380c3f69-cda5-48f1-a155-adb25527e272 68016-500 HUMAN OTC DRUG Premier Value Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Chain Drug Consortium BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 68016-523_dfb43a3f-20fa-4247-9f69-b0d4e696157b 68016-523 HUMAN OTC DRUG Premier Value Illuminating Daily Moisturizer Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Chain Drug Consortium, LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 g/100mL; g/100mL; g/100mL 68016-526_ff6c4d5a-54af-4dde-b50c-feead82efbc8 68016-526 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Premier Value LORATADINE 10 mg/1 68016-527_13fdbde7-41db-4cf8-94b9-ce42bd3d8da0 68016-527 HUMAN OTC DRUG Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Premier Value LORATADINE 10 mg/1 68016-532_52dc95b6-9568-4966-9d2e-2414662d2265 68016-532 HUMAN OTC DRUG STOOL SOFTENER Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 Premier Value (Chain Drug Consortium, LLC) DOCUSATE SODIUM 250 mg/1 68016-593_b58a9f9c-4339-4b0e-b2f1-80eba8fa9a11 68016-593 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20140831 OTC MONOGRAPH FINAL part347 Premier Value (Chain Drug Consortium, LLC) WITCH HAZEL 842 mg/mL 68016-693_d6a4bcc9-22b8-4e9e-b75e-96e2a996f569 68016-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19931004 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium MAGNESIUM CITRATE 1.745 g/29.6mL 68016-724_914a6d06-62ef-4675-83b3-d5578de7584b 68016-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Premier Value LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 68016-731_5bef17ad-5c23-4d0b-992d-8f25d9b97adf 68016-731 HUMAN OTC DRUG Miconazole 3 Combination Pack Miconazole Nitrate KIT 20030911 ANDA ANDA074926 Premier Value 68016-760_75dd429a-2a81-c18e-864e-d1993db001bd 68016-760 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20131126 ANDA ANDA078878 Chain Drug Consortium, LLC OMEPRAZOLE MAGNESIUM 20 mg/1 68016-804_5b5c898c-9f2e-4b0d-bee0-55f56709de89 68016-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20030815 OTC MONOGRAPH NOT FINAL part333A Chain Drug Consotium ISOPROPYL ALCOHOL .91 mg/mL 68016-822_a9ee7d52-1fb2-424a-b851-a9a4511d8694 68016-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 20030815 OTC MONOGRAPH FINAL part347 Chain Drug Consortium, LLC WITCH HAZEL 18 kg/100L 68016-823_7abd5317-86e4-46a9-b504-8955d5861fff 68016-823 HUMAN OTC DRUG Childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20120911 OTC MONOGRAPH FINAL part336 Chain Drug Consortium, LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 68016-855_56d2cb5f-41d0-40e4-9d2b-bbabd03875a6 68016-855 HUMAN OTC DRUG Tussin DM COUGH SUPPRESSANT/EXPECTORANT DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20120901 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 68016-871_30fa1e48-705f-406f-b60a-2f47179595d6 68016-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20030813 OTC MONOGRAPH NOT FINAL part333A Chain Drug Consortium, LLC HYDROGEN PEROXIDE .3 kg/100L 68016-939_420dc5b2-b249-413a-aa9e-4cfce60be6c8 68016-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Premier Value CETIRIZINE HYDROCHLORIDE 10 mg/1 68016-952_6215d94c-10e9-4014-88e2-bcedf06eca55 68016-952 HUMAN OTC DRUG Hand wash Benzalkonium chloride LIQUID TOPICAL 20140828 OTC MONOGRAPH NOT FINAL part333A Chain Drug Consortium BENZALKONIUM CHLORIDE 1.3 mg/mL 68021-1001_14e6bc69-81e3-46c0-9ca6-232d82a0cbf8 68021-1001 HUMAN OTC DRUG Erborian BB Creme Au Ginseng TITANIUM DIOXIDE CREAM TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part352 Kolmar Korea Co Ltd OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 6.388; 1.96 mL/100mL; mL/100mL; mL/100mL 68021-1002_9ff74873-57a3-4c17-bbc8-95f652f98de6 68021-1002 HUMAN OTC DRUG Erborian BB Creme Au Ginseng Dore Titanium Dioxide CREAM TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part352 Kolmar Korea Co Ltd OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 6.39; 1.92 mL/100mL; mL/100mL; mL/100mL 68022-0001_badeb55f-a1e5-486d-88fb-1b7dad9c7a73 68022-0001 HUMAN PRESCRIPTION DRUG Malathion Malathion LOTION TOPICAL 20140220 ANDA ANDA091559 Suven Life Sciences Limited MALATHION .005 g/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68025-037_7fda4bfa-e98e-4b85-90d5-4b9b9a241bbe 68025-037 HUMAN PRESCRIPTION DRUG Zotex-C CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE AND PYRILAMINE MALEATE SYRUP ORAL 20081010 UNAPPROVED DRUG OTHER Vertical Pharmaceuticals, Inc. CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE 10; 5; 5 mg/5mL; mg/5mL; mg/5mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] CV 68025-040_c45555c7-1afc-43c3-a057-28659b38ca89 68025-040 HUMAN PRESCRIPTION DRUG ZyPram Hydrocortisone Acetate and Pramoxine Hydrochloride CREAM TOPICAL 20090721 UNAPPROVED OTHER Vertical Pharmaceuticals, Inc HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 705; 300 mg/30g; mg/30g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68025-041_1960c29a-4512-4146-93bb-2070d4d3a76a 68025-041 HUMAN PRESCRIPTION DRUG Trioxin Chloroxylenol, Benzocaine and Hydrocortisone Acetate SOLUTION/ DROPS AURICULAR (OTIC) 20090702 UNAPPROVED OTHER Vertical Pharmaceuticals, Inc BENZOCAINE; CHLOROXYLENOL; HYDROCORTISONE ACETATE 15; 1; 10 mg/mL; mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68025-046_bdd61b83-5bcd-4d23-8ef5-aeb9ca2f7c14 68025-046 HUMAN PRESCRIPTION DRUG Lorzone chlorzoxazone TABLET ORAL 20111001 ANDA ANDA040861 Vertical Pharmaceuticals, Inc. CHLORZOXAZONE 375 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68025-047_bdd61b83-5bcd-4d23-8ef5-aeb9ca2f7c14 68025-047 HUMAN PRESCRIPTION DRUG Lorzone chlorzoxazone TABLET ORAL 20111001 ANDA ANDA040861 Vertical Pharmaceuticals, Inc. CHLORZOXAZONE 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68025-053_4084dcf5-c68a-4ce7-8fce-1f16f5f9a6b2 68025-053 HUMAN PRESCRIPTION DRUG ConZip tramadol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110831 NDA NDA022370 Vertical Pharmaceuticals Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 68025-055_4084dcf5-c68a-4ce7-8fce-1f16f5f9a6b2 68025-055 HUMAN PRESCRIPTION DRUG ConZip tramadol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110831 NDA NDA022370 Vertical Pharmaceuticals Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 68025-056_4084dcf5-c68a-4ce7-8fce-1f16f5f9a6b2 68025-056 HUMAN PRESCRIPTION DRUG ConZip tramadol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110831 NDA NDA022370 Vertical Pharmaceuticals Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 68025-058_b85137e4-5e8b-4134-9a8e-1e6f9da63f92 68025-058 HUMAN PRESCRIPTION DRUG Zonatuss benzonatate CAPSULE ORAL 20111101 ANDA ANDA040851 Vertical Pharmaceuticals, Inc. BENZONATATE 150 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 68025-065_d68ac2d4-c579-4b40-99ca-980c869ec8a1 68025-065 HUMAN PRESCRIPTION DRUG DiviGel Estradiol GEL TOPICAL 20141027 NDA NDA022038 Vertical Pharmaceuticals, LLC ESTRADIOL .25 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 68025-066_d68ac2d4-c579-4b40-99ca-980c869ec8a1 68025-066 HUMAN PRESCRIPTION DRUG DiviGel Estradiol GEL TOPICAL 20141027 NDA NDA022038 Vertical Pharmaceuticals, LLC ESTRADIOL .5 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 68025-067_d68ac2d4-c579-4b40-99ca-980c869ec8a1 68025-067 HUMAN PRESCRIPTION DRUG DiviGel Estradiol GEL TOPICAL 20141027 NDA NDA022038 Vertical Pharmaceuticals, LLC ESTRADIOL 1 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 68025-071_12fa67e4-f47e-4118-aeef-9f9cd723947f 68025-071 HUMAN PRESCRIPTION DRUG ConZip tramadol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110831 NDA NDA022370 Vertical Pharmaceuticals, LLC TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68025-072_12fa67e4-f47e-4118-aeef-9f9cd723947f 68025-072 HUMAN PRESCRIPTION DRUG ConZip tramadol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110831 NDA NDA022370 Vertical Pharmaceuticals, LLC TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68025-073_12fa67e4-f47e-4118-aeef-9f9cd723947f 68025-073 HUMAN PRESCRIPTION DRUG ConZip tramadol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110831 NDA NDA022370 Vertical Pharmaceuticals, LLC TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68026-101_54987ae2-beec-4a66-a21e-788655dab609 68026-101 HUMAN OTC DRUG Skin Caviar Concealer Foundation SPF 15 - Porcelaine Blush OCTINOXATE LIQUID TOPICAL 20110407 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 60 mg/mL 68026-102_5db35c96-97a8-443f-9e3d-4a5774428b23 68026-102 HUMAN OTC DRUG SKIN CAVIAR CONCEALER FOUNDATION SUNSCREEN SPF 15 - Creme Peche OCTINOXATE LIQUID TOPICAL 20131021 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 60 mg/mL 68026-103_a44ba8c7-9964-4182-8a79-51bf12785c01 68026-103 HUMAN OTC DRUG SKIN CAVIAR CONCEALER FOUNDATION SUNSCREEN SPF 15 - Creme Blush OCTINOXATE LIQUID TOPICAL 20131021 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 60 mg/mL 68026-104_38ed13bd-212b-4e15-b92f-0b431a39006b 68026-104 HUMAN OTC DRUG SKIN CAVIAR CONCEALER FOUNDATION SUNSCREEN SPF 15 - Peche OCTINOXATE LIQUID TOPICAL 20131021 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 60 mg/mL 68026-105_ec9e7937-98fb-4a62-9dcc-352838beceb7 68026-105 HUMAN OTC DRUG SKIN CAVIAR CONCEALER FOUNDATION SUNSCREEN SPF 15 - Sand Beige OCTINOXATE LIQUID TOPICAL 20131021 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 60 mg/mL 68026-106_aebc32e0-98f5-4ed0-8b3b-81f322d69bcc 68026-106 HUMAN OTC DRUG SKIN CAVIAR CONCEALER FOUNDATION SUNSCREEN SPF 15 - Honey Beige OCTINOXATE LIQUID TOPICAL 20131021 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 60 mg/mL 68026-107_50a9bd6a-7ff7-4a82-81ac-d9432729ad07 68026-107 HUMAN OTC DRUG SKIN CAVIAR CONCEALER FOUNDATION SUNSCREEN SPF 15 - Soleil Peche OCTINOXATE LIQUID TOPICAL 20131021 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 60 mg/mL 68026-108_a022d902-312f-4134-812c-4702b097f903 68026-108 HUMAN OTC DRUG SKIN CAVIAR CONCEALER FOUNDATION SUNSCREEN SPF 15 - Golden Beige OCTINOXATE LIQUID TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 60 mg/mL 68026-112_62936a97-fb41-4fe4-a789-2e666ea9b39d 68026-112 HUMAN OTC DRUG SKIN CAVIAR CONCEALER FOUNDATION SUNSCREEN SPF 15 - Mocha OCTINOXATE LIQUID TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 60 mg/mL 68026-113_332d9eb4-d465-4d37-b68d-0b68ed62ad24 68026-113 HUMAN OTC DRUG SKIN CAVIAR CONCEALER FOUNDATION SUNSCREEN SPF 15 - Ivoire OCTINOXATE LIQUID TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 60 mg/mL 68026-114_4aca20d8-d937-4986-a4ea-19ed5ece6f7d 68026-114 HUMAN OTC DRUG SKIN CAVIAR CONCEALER FOUNDATION SUNSCREEN SPF 15 - Soft Beige OCTINOXATE LIQUID TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 60 mg/mL 68026-115_d95dd090-04d2-4368-9932-f52f2a1af468 68026-115 HUMAN OTC DRUG SKIN CAVIAR CONCEALER FOUNDATION SUNSCREEN SPF 15 - Beige OCTINOXATE LIQUID TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 60 mg/mL 68026-241_c30a798e-18a3-40c0-8af3-4737977b903a 68026-241 HUMAN OTC DRUG ADVANCED MARINE BIOLOGY DAY SUNSCREEN BROAD SPECTRUM SPF 20 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL 68026-341_a303e11e-8ee9-4523-8a61-80884bfc57d5 68026-341 HUMAN OTC DRUG WHITE CAVIAR ILLUMINATING HAND SUNSCREEN BROAD SPECTRUM SPF 15 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 50; 40; 30; 15 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 68026-342_b67931fe-d101-4e3a-9bd2-d9f5ccf98f61 68026-342 HUMAN OTC DRUG WHITE CAVIAR ILLUMINATING HAND SUNSCREEN BROAD SPECTRUM SPF 15 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 50; 40; 30; 15 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 68026-414_36ce76fa-9857-4d65-a9b7-595ca7f42c18 68026-414 HUMAN OTC DRUG CELLULAR ANTI-WRINKLE SUN SUNCREEN BROAD SPECTRUM SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 75; 26; 24; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 68026-421_8e373c14-2cd2-4e21-aea9-c69bda5e9b4e 68026-421 HUMAN OTC DRUG ULTRA PROTECTION EYE LIP NOSE SUNSCREEN BROAD SPECTRUM SPF 40 AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE STICK TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 7; 5; 2 g/100g; g/100g; g/100g; g/100g 68026-422_f5861fbc-b1ce-426b-b13a-0a9b188870ce 68026-422 HUMAN OTC DRUG SUN PROTECTION FACE SUNSCREN BROAD SPECTRUM SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE EMULSION TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 26; 24; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL 68026-423_2c9e3b35-b578-4205-8846-0fed7ac8bec4 68026-423 HUMAN OTC DRUG SUN PROTECTION BODY SUNSCREEN BROAD SPECTRUM SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 30; 70; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL 68026-501_fa42cd6a-bce7-4521-aa29-847bb63d80cc 68026-501 HUMAN OTC DRUG ANTI-AGING EYE SUNSCREEN BROAD SPECTRUM SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20110412 OTC MONOGRAPH FINAL part352 La Prairie, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 20; 75; 30 mg/mL; mg/mL; mg/mL 68026-502_0a74aac1-1079-462d-8458-d72bb85181ef 68026-502 HUMAN OTC DRUG ANTI-AGING SUNSCREEN BROAD SPECTRUM SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE EMULSION TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 28; 75; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL 68026-503_c58a7ae3-00f9-420a-a8f9-f16924bd37ed 68026-503 HUMAN OTC DRUG ANTI-AGING DAY SUNSCREEN BROAD SPECTRUM SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 75; 50; 25 mg/mL; mg/mL; mg/mL; mg/mL 68026-521_50563a5b-89c6-44b7-8c21-b835c1c34bf3 68026-521 HUMAN OTC DRUG Anti-Aging Foundation SPF 15 Shade 100 OCTINOXATE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 75 mg/mL 68026-522_250d8f86-cb52-45ae-92a7-fada5fba8044 68026-522 HUMAN OTC DRUG Anti-Aging Foundation SPF 15 Shade 200 OCTINOXATE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 75 mg/mL 68026-523_309741f8-3606-45ea-8463-b4a163db102a 68026-523 HUMAN OTC DRUG Anti-Aging Foundation SPF 15 Shade 300 OCTINOXATE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 75 mg/mL 68026-524_902aeeda-1db6-4efb-8b8a-7836685b9fb5 68026-524 HUMAN OTC DRUG Anti-Aging Foundation SPF 15 Shade 400 OCTINOXATE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 75 mg/mL 68026-525_d86731e0-32d7-44cf-ab67-77abafc2a984 68026-525 HUMAN OTC DRUG Anti-Aging Foundation SPF 15 Shade 500 OCTINOXATE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 75 mg/mL 68026-526_66d534d1-5d2d-45ef-8b09-86b122ba08ac 68026-526 HUMAN OTC DRUG Anti-Aging Foundation SPF 15 Shade 600 OCTINOXATE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 75 mg/mL 68026-527_45a87715-a400-48ee-8fe1-c095247f3f07 68026-527 HUMAN OTC DRUG Anti-Aging Foundation SPF 15 Shade 700 OCTINOXATE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 75 mg/mL 68026-528_acbf7c9d-1876-4770-b4a7-7e37f151eeed 68026-528 HUMAN OTC DRUG Anti-Aging Foundation SPF 15 Shade 800 OCTINOXATE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 75 mg/mL 68026-531_a2ad3d2e-ff62-427c-a171-fcd77fea2019 68026-531 HUMAN OTC DRUG ANTI-AGING CONCEALER FACE EYES SUNSCREEN SPF 20 Shade 10 OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 75; 5; 2 mg/mL; mg/mL; mg/mL 68026-532_2af6acbd-0139-4c24-8029-80165d34ab5c 68026-532 HUMAN OTC DRUG ANTI-AGING CONCEALER FACE EYES SUNSCREEN SPF 20 Shade 20 OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 75; 5; 2 mg/mL; mg/mL; mg/mL 68026-533_8f06b30c-1591-4e96-835c-4a24da8c51d3 68026-533 HUMAN OTC DRUG ANTI-AGING CONCEALER FACE EYES SUNSCREEN SPF 20 Shade 30 OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 75; 5; 2 mg/mL; mg/mL; mg/mL 68026-534_aaef34dc-01b0-4a7a-86d5-cd2f846163ec 68026-534 HUMAN OTC DRUG ANTI-AGING CONCEALER FACE EYES SUNSCREEN SPF 20 Shade 40 OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 75; 5; 2 mg/mL; mg/mL; mg/mL 68026-541_4a5794d5-08e9-4940-bad1-63b2dbacaa49 68026-541 HUMAN OTC DRUG Anti-Aging Hydra Tint SPF 20 Shade 10 OCTINOXATE, OXYBENZONE CREAM TOPICAL 20131023 OTC MONOGRAPH FINAL part352 La Prairie, Inc. OCTINOXATE; OXYBENZONE 75; 35 mg/mL; mg/mL 68026-542_1dfe7fea-18a9-411e-b61d-d03e36c85cd8 68026-542 HUMAN OTC DRUG Anti-Aging Hydra Tint SPF 20 Shade 20 OCTINOXATE, OXYBENZONE CREAM TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. OCTINOXATE; OXYBENZONE 75; 35 mg/mL; mg/mL 68026-543_aa0eb1b3-d1f1-4e1d-ac13-dba241aaf3d4 68026-543 HUMAN OTC DRUG Anti-Aging Hydra Tint SPF 20 Shade 30 OCTINOXATE, OXYBENZONE CREAM TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. OCTINOXATE; OXYBENZONE 75; 35 mg/mL; mg/mL 68026-544_7b184d54-7672-49db-af28-28e639262fdb 68026-544 HUMAN OTC DRUG Anti-Aging Hydra Tint SPF 20 Shade 40 OCTINOXATE, OXYBENZONE CREAM TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. OCTINOXATE; OXYBENZONE 75; 35 mg/mL; mg/mL 68026-650_961fd5f4-2735-4763-a4c0-0ae83da6daf1 68026-650 HUMAN OTC DRUG CELLULAR RADIANCE SUNSCREEN SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE EMULSION TOPICAL 20131022 OTC MONOGRAPH FINAL part352 La Prairie, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 30 mg/mL; mg/mL; mg/mL 68040-702_4acf85e5-f2d5-40b0-8562-2427a2ab56be 68040-702 HUMAN PRESCRIPTION DRUG Alcortin 1% iodoquinol - 2% hydrocortisone GEL TOPICAL 20030725 UNAPPROVED DRUG OTHER Primus Pharmaceuticals HYDROCORTISONE; IODOQUINOL 2; 1 g/100g; g/100g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68040-705_9cb495f1-7fac-495a-8775-c9388c8a15d3 68040-705 HUMAN PRESCRIPTION DRUG Alcortin A HYDROCORTISONE ACETATE, ALOE VERA LEAF and Iodoquinol GEL TOPICAL 20100101 UNAPPROVED OTHER Primus Pharmaceuticals ALOE VERA LEAF; HYDROCORTISONE ACETATE; IODOQUINOL 10; 20; 10 mg/g; mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68040-706_610958fb-6663-430c-854a-1b7f36c8c80a 68040-706 HUMAN PRESCRIPTION DRUG Aloquin Aloe Vera Leaf and Iodoquinol GEL TOPICAL 20090706 UNAPPROVED OTHER Primus Pharmaceuticals ALOE VERA LEAF; IODOQUINOL 10; 12.5 mg/g; mg/g 68046-001_597ffa8b-a6a4-49db-b878-f17327bc97b6 68046-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130823 UNAPPROVED MEDICAL GAS P.A.L. Home Diagnostics & Respiratory Care Inc. OXYGEN 99 L/100L 68047-051_4ca73174-fa95-4afa-aef1-4879dbcfcbc3 68047-051 HUMAN PRESCRIPTION DRUG Oto End 10 Pramoxine HCl / Hydrocortisone / Chloroxylenol SOLUTION/ DROPS AURICULAR (OTIC) 20071012 UNAPPROVED DRUG OTHER Larken Laboratories, Inc. CHLOROXYLENOL; HYDROCORTISONE; PRAMOXINE HYDROCHLORIDE 1; 10; 10 mg/mL; mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68047-057_b55e894b-4483-4cb4-a296-04d3623bf6ff 68047-057 HUMAN PRESCRIPTION DRUG Pennacaine benzocaine SOLUTION/ DROPS AURICULAR (OTIC) 20110808 UNAPPROVED DRUG OTHER Larken Laboratories, Inc. BENZOCAINE 200 mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 68047-120_bcf0e30c-3269-41bb-9bd4-70f0be8449d8 68047-120 HUMAN OTC DRUG LoHist D Chlorpheniramine Maleate / Pseudoephedrine HCl LIQUID ORAL 20030915 OTC MONOGRAPH FINAL part341 Larken Laboratories, Inc. CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 30 mg/5mL; mg/5mL 68047-129_102ed202-f5f2-4923-9958-4a81b11f5a13 68047-129 HUMAN OTC DRUG LoHist DM Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20120601 OTC MONOGRAPH FINAL part341 Larken Laboratories, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/5mL; mg/5mL; mg/5mL 68047-143_b13c6c74-2a3e-48be-872b-7940cc11b416 68047-143 HUMAN OTC DRUG EndaCof DM Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20120330 OTC MONOGRAPH FINAL part341 Larken Laboratories, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL 68047-149_091acdd1-f145-4d40-b904-a0d834e07fae 68047-149 HUMAN OTC DRUG EndaCof C Codeine Phosphate and Chlorpheniramine Maleate LIQUID ORAL 20090525 OTC MONOGRAPH FINAL part341 Larken Laboratories, Inc. CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 2; 10 mg/5mL; mg/5mL CV 68047-155_f68b76be-08e4-4bf9-b798-3b989a976e65 68047-155 HUMAN OTC DRUG ExeFen DMX Dextromethorphan Hydrobromide, Guaifenesin and Pseudoephedrine Hydrochloride TABLET ORAL 20110328 OTC MONOGRAPH FINAL part341 Larken Laboratories, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 20; 400; 60 mg/1; mg/1; mg/1 68047-157_67e35b1d-ac0b-49b3-b1a6-2d6a1e496144 68047-157 HUMAN OTC DRUG ExeFen IR Guaifenesin and Pseudoephedrine Hydrochloride TABLET ORAL 20110110 OTC MONOGRAPH FINAL part341 Larken Laboratories, Inc. GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 400; 60 mg/1; mg/1 68047-185_0307deb5-c508-4915-bc32-9074865f0cf1 68047-185 HUMAN OTC DRUG NoHist LQ Chlorpheniramine Maleate and Phenylephrine Hydrochloride LIQUID ORAL 20110106 OTC MONOGRAPH FINAL part341 Larken Laboratories, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/5mL; mg/5mL 68047-186_77e3bfcc-f384-451a-a065-dc58b7a15bf2 68047-186 HUMAN OTC DRUG NoHist DM Chlorpheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20110106 OTC MONOGRAPH FINAL part341 Larken Laboratories, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 15; 10 mg/5mL; mg/5mL; mg/5mL 68047-222_5e470c5c-528b-4d2d-a73a-b58f08f0517d 68047-222 HUMAN PRESCRIPTION DRUG ExeClear C Codeine Phosphate / Guaifenesin LIQUID ORAL 20081017 UNAPPROVED DRUG OTHER Larken Laboratories, Inc. CODEINE PHOSPHATE; GUAIFENESIN 10; 2 mg/5mL; mg/5mL CV 68047-252_dee0db04-0ee0-4aa7-a333-e7848883cff4 68047-252 HUMAN PRESCRIPTION DRUG OSCIMIN Hyoscyamine Sulfate TABLET ORAL 20110803 UNAPPROVED DRUG OTHER Larken Laboratories, Inc. HYOSCYAMINE SULFATE .125 mg/1 68047-253_0b18fdd9-afd3-4500-ae20-854ef9bcf78e 68047-253 HUMAN PRESCRIPTION DRUG OSCIMIN Hyoscyamine Sulfate TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20110803 UNAPPROVED DRUG OTHER Larken Laboratories, Inc. HYOSCYAMINE SULFATE .125 mg/1 68047-254_5bfaf3fd-06a9-4585-b9f2-01da31ab08eb 68047-254 HUMAN PRESCRIPTION DRUG OSCIMIN Hyoscyamine Sulfate TABLET, ORALLY DISINTEGRATING ORAL 20110803 UNAPPROVED DRUG OTHER Larken Laboratories, Inc. HYOSCYAMINE SULFATE .125 mg/1 68047-255_723e7cab-1921-4af4-a27c-03c4ea6f012e 68047-255 HUMAN PRESCRIPTION DRUG OSCIMIN Hyoscyamine Sulfate TABLET, EXTENDED RELEASE ORAL 20110803 UNAPPROVED DRUG OTHER Larken Laboratories, Inc. HYOSCYAMINE SULFATE .375 mg/1 68047-340_732d201e-a7eb-4374-b9aa-6f03b459ef28 68047-340 HUMAN OTC DRUG LoHist PEB Brompheniramine Maleate and Phenylephrine Hydrochloride LIQUID ORAL 20110106 OTC MONOGRAPH FINAL part341 Larken Laboratories, Inc. BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/5mL; mg/5mL 68047-341_0119c58f-46f6-419d-b761-634af080a231 68047-341 HUMAN OTC DRUG LoHist PEB DM Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20110106 OTC MONOGRAPH FINAL part341 Larken Laboratories, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 20; 10 mg/5mL; mg/5mL; mg/5mL 68047-714_63d79530-85a9-4939-a0e1-a78722ab4f07 68047-714 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20101115 ANDA ANDA065287 Larken Laboratories, Inc. DOXYCYCLINE HYCLATE 20 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 68048-822_a33b8d79-3c08-4d7c-a131-c006d06d541b 68048-822 HUMAN OTC DRUG Jimin Zhuifeng Gao Menthol, Methyl Salicylate PLASTER TRANSDERMAL 20070701 OTC MONOGRAPH NOT FINAL part348 Guangdong Zhanjiang Jimin Pharmaceutical Co. Ltd MENTHOL; METHYL SALICYLATE 9; 9 g/100g; g/100g 68083-111_32cf74d8-23f2-40a0-b9a6-30df1cf17eb9 68083-111 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20120419 ANDA ANDA090699 Gland Pharma Limited LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68083-131_47e20cb8-c2be-42cb-aeef-13d403ecb693 68083-131 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION INTRAVENOUS 20141006 ANDA ANDA204205 Gland Pharma Limited METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68083-199_0ecf91ee-4392-42bc-9489-db9b1f8fbcb6 68083-199 HUMAN PRESCRIPTION DRUG Azithromycin monohydrate Azithromycin monohydrate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091109 ANDA ANDA065501 Gland Pharma Limited AZITHROMYCIN MONOHYDRATE 500 mg/10mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68084-002_39d504f9-250a-458e-aa65-7439fa25aaeb 68084-002 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20130624 ANDA ANDA090695 American Health Packaging LOXAPINE SUCCINATE 10 mg/1 68084-003_39d504f9-250a-458e-aa65-7439fa25aaeb 68084-003 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20130624 ANDA ANDA090695 American Health Packaging LOXAPINE SUCCINATE 25 mg/1 68084-004_39d504f9-250a-458e-aa65-7439fa25aaeb 68084-004 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20130624 ANDA ANDA090695 American Health Packaging LOXAPINE SUCCINATE 50 mg/1 68084-005_ad42c611-c15a-472f-a701-0d722d3819f7 68084-005 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20130515 ANDA ANDA078281 American Health Packaging PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68084-006_ad42c611-c15a-472f-a701-0d722d3819f7 68084-006 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20130515 ANDA ANDA078281 American Health Packaging PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68084-007_fb7c569a-d41d-429d-8e05-e73c1ae4b380 68084-007 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20130612 ANDA ANDA203081 American Health Packaging IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68084-008_2964a1de-2eb6-4011-9c38-52fb4e738402 68084-008 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20130719 ANDA ANDA077636 American Health Packaging ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-009_a6fb8945-77ed-46e3-a68f-0fc9dd7eb4b1 68084-009 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20130723 ANDA ANDA070581 American Health Packaging METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 68084-013_fa7e641b-90c5-4fc1-90d3-29ee922086ce 68084-013 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride TABLET ORAL 20130708 ANDA ANDA076286 American Health Packaging TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68084-014_5a956d5a-9981-42d9-8b8b-992c6d9106a8 68084-014 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20060621 20150904 ANDA ANDA076796 American Health Packaging FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 68084-016_5a956d5a-9981-42d9-8b8b-992c6d9106a8 68084-016 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20060622 ANDA ANDA076796 American Health Packaging FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 68084-017_5a956d5a-9981-42d9-8b8b-992c6d9106a8 68084-017 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20060622 20150913 ANDA ANDA076796 American Health Packaging FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 68084-018_cae60d4e-ef06-4cd9-bdb2-07f682d2de6e 68084-018 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20130528 ANDA ANDA074112 American Health Packaging ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-019_cae60d4e-ef06-4cd9-bdb2-07f682d2de6e 68084-019 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20130528 ANDA ANDA074112 American Health Packaging ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-020_cae60d4e-ef06-4cd9-bdb2-07f682d2de6e 68084-020 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20130528 ANDA ANDA074112 American Health Packaging ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-021_01e46f58-8bda-4ff3-ab21-57d5b540d440 68084-021 HUMAN PRESCRIPTION DRUG Abacavir Abacavir Sulfate TABLET, FILM COATED ORAL 20130207 ANDA ANDA077844 American Health Packaging ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 68084-022_ea5edb3f-f718-4e48-aac6-57aefef60bbc 68084-022 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE, LIQUID FILLED ORAL 20130605 ANDA ANDA072579 American Health Packaging NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68084-027_f124cc2b-2b1a-40f8-b203-515069d4c08e 68084-027 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20120402 ANDA ANDA040301 American Health Packaging WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 68084-028_cb914667-0b1b-4584-a40c-7d34198bf459 68084-028 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20130528 ANDA ANDA074253 American Health Packaging BUSPIRONE HYDROCHLORIDE 5 mg/1 68084-029_cb914667-0b1b-4584-a40c-7d34198bf459 68084-029 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20130528 ANDA ANDA074253 American Health Packaging BUSPIRONE HYDROCHLORIDE 10 mg/1 68084-030_cb914667-0b1b-4584-a40c-7d34198bf459 68084-030 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20130528 ANDA ANDA074253 American Health Packaging BUSPIRONE HYDROCHLORIDE 15 mg/1 68084-031_64c74ccf-23c4-42c3-b55a-3c5d18056ea8 68084-031 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20110519 ANDA ANDA073553 American Health Packaging NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 68084-032_64c74ccf-23c4-42c3-b55a-3c5d18056ea8 68084-032 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20110519 ANDA ANDA073554 American Health Packaging NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 68084-038_e06518e7-4503-40da-829c-6000dc757367 68084-038 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20110421 ANDA ANDA072824 American Health Packaging BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 68084-039_e06518e7-4503-40da-829c-6000dc757367 68084-039 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20110421 ANDA ANDA072825 American Health Packaging BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 68084-040_f902a2a6-0420-4632-a19b-050e40db6803 68084-040 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20130716 ANDA ANDA091667 American Health Packaging MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 68084-041_f902a2a6-0420-4632-a19b-050e40db6803 68084-041 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20130716 ANDA ANDA091667 American Health Packaging MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] 68084-044_4a9fd4a5-1fa5-4d6e-a1c1-0cc9e05fda84 68084-044 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20110519 ANDA ANDA077584 American Health Packaging PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-045_4a9fd4a5-1fa5-4d6e-a1c1-0cc9e05fda84 68084-045 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20110519 ANDA ANDA077584 American Health Packaging PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-046_4a9fd4a5-1fa5-4d6e-a1c1-0cc9e05fda84 68084-046 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20110519 ANDA ANDA077584 American Health Packaging PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-047_4a9fd4a5-1fa5-4d6e-a1c1-0cc9e05fda84 68084-047 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20110519 ANDA ANDA077584 American Health Packaging PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-048_eb81c007-9f19-47dc-8a36-69770676fc5d 68084-048 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20140925 ANDA ANDA077290 American Health Packaging OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68084-050_86aec0c3-0032-415c-928f-ba2232b12e8f 68084-050 HUMAN OTC DRUG Senna Plus Senna Plus TABLET ORAL 20100114 UNAPPROVED DRUG OTHER American Health Packaging DOCUSATE SODIUM; SENNOSIDES 50; 8.6 ug/1; mg/1 68084-051_66b54afb-dd2e-4a9a-b523-10330e0ed163 68084-051 HUMAN PRESCRIPTION DRUG Nabumetone Nabumentone TABLET ORAL 20131028 ANDA ANDA075280 American Health Packaging NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68084-052_7dc13ebc-914c-4237-9298-b708239b380c 68084-052 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20121212 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68084-052_f7a87108-c0f7-424d-8616-1b42afef9a53 68084-052 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20121211 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68084-053_7dc13ebc-914c-4237-9298-b708239b380c 68084-053 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20121212 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68084-053_f7a87108-c0f7-424d-8616-1b42afef9a53 68084-053 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20121211 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68084-054_7dc13ebc-914c-4237-9298-b708239b380c 68084-054 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20121212 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68084-054_f7a87108-c0f7-424d-8616-1b42afef9a53 68084-054 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20121211 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68084-055_7dc13ebc-914c-4237-9298-b708239b380c 68084-055 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20121212 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68084-055_f7a87108-c0f7-424d-8616-1b42afef9a53 68084-055 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20121211 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68084-056_9e12e018-ea14-4da2-a6f5-d9934c0511c3 68084-056 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130626 ANDA ANDA090200 American Health Packaging METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68084-057_9e12e018-ea14-4da2-a6f5-d9934c0511c3 68084-057 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130626 ANDA ANDA090200 American Health Packaging METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68084-059_a60f39f6-d590-4b00-8751-7f12b7ec5385 68084-059 HUMAN PRESCRIPTION DRUG Zafirlukast Zafirlukast TABLET, FILM COATED ORAL 20130607 ANDA ANDA090372 American Health Packaging ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68084-060_2c4c085b-45b4-4b11-9a1c-820bb8a97a64 68084-060 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20050922 ANDA ANDA078402 American Health Packaging LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-061_2c4c085b-45b4-4b11-9a1c-820bb8a97a64 68084-061 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20050922 ANDA ANDA078402 American Health Packaging LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-062_2c4c085b-45b4-4b11-9a1c-820bb8a97a64 68084-062 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20050922 ANDA ANDA078402 American Health Packaging LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-064_2c4c085b-45b4-4b11-9a1c-820bb8a97a64 68084-064 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20050922 20151205 ANDA ANDA078402 American Health Packaging LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-065_89242d27-8db8-4975-90f3-0e00d0d3d32f 68084-065 HUMAN PRESCRIPTION DRUG Nephrocaps Ascorbic Acid, Folic Acid, Niacin, Thiamine, Riboflavin, Pyridoxine, Cyanocobalamin, Pantothenic Acid, Biotin CAPSULE, LIQUID FILLED ORAL 20100114 UNAPPROVED DRUG OTHER American Health Packaging ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; THIAMINE 100; 150; 6; 1; 20; 5; 10; 1.7; 1.5 mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 68084-066_09853e2b-6b8c-4a03-b458-5fd988b36d7b 68084-066 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20130725 ANDA ANDA077031 American Health Packaging CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-069_dd0442f8-0e41-4251-9b4b-53d5a33b24fe 68084-069 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20130708 ANDA ANDA076794 American Health Packaging CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68084-070_dd0442f8-0e41-4251-9b4b-53d5a33b24fe 68084-070 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20130708 ANDA ANDA076794 American Health Packaging CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68084-071_dd0442f8-0e41-4251-9b4b-53d5a33b24fe 68084-071 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20130708 ANDA ANDA076794 American Health Packaging CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68084-072_a57dab54-fe14-420b-88ca-d4270e7689f2 68084-072 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101021 ANDA ANDA078596 American Health Packaging METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68084-074_4d68cce9-d9f1-4260-9e68-a106b4fdd4b3 68084-074 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 20080827 ANDA ANDA077246 American Health Packaging DANAZOL 200 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 68084-075_b22d5a07-623a-4645-b87d-a151b86da8d5 68084-075 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CAPSULE ORAL 20130718 ANDA ANDA201687 American Health Packaging TRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] 68084-077_9b15533c-61e8-4d76-8323-012c2e922bbe 68084-077 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20140217 NDA NDA016620 American Health Packaging NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 68084-078_9b15533c-61e8-4d76-8323-012c2e922bbe 68084-078 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20140217 NDA NDA016620 American Health Packaging NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 68084-079_21d73b96-9ca5-4959-91e7-c8536118a761 68084-079 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041210 ANDA ANDA075350 AMERISOURCEBERGEN DRUG CORPORATION GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-081_21d73b96-9ca5-4959-91e7-c8536118a761 68084-081 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041210 ANDA ANDA075350 AMERISOURCEBERGEN DRUG CORPORATION GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-082_5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1 68084-082 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 20131015 ANDA ANDA086925 American Health Packaging ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68084-083_5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1 68084-083 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 20131015 ANDA ANDA087537 American Health Packaging ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68084-084_c1829c84-80f5-4513-af2e-fc7a0476a0ba 68084-084 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20100112 ANDA ANDA077414 American Health Packaging DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 68084-085_c1829c84-80f5-4513-af2e-fc7a0476a0ba 68084-085 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20100112 ANDA ANDA077414 American Health Packaging DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 68084-086_8d26afa4-4523-4b8d-81ea-9a38351562c4 68084-086 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20120402 ANDA ANDA040412 American Health Packaging HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68084-088_09eb2286-4886-4f12-8a3a-a293c65c28c7 68084-088 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20080501 ANDA ANDA071403 American Health Packaging LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-089_09eb2286-4886-4f12-8a3a-a293c65c28c7 68084-089 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20080501 ANDA ANDA071404 American Health Packaging LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-090_09eb2286-4886-4f12-8a3a-a293c65c28c7 68084-090 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20080501 ANDA ANDA071141 American Health Packaging LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-091_53a6d422-f831-4d09-bf2a-590878eedfae 68084-091 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide hydrochloride TABLET ORAL 20050623 ANDA ANDA070581 American Health Packaging METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 68084-093_dbeede8d-f137-43e7-889d-9661b69e63c2 68084-093 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20050713 ANDA ANDA074260 American Health Packaging CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 68084-094_dbeede8d-f137-43e7-889d-9661b69e63c2 68084-094 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20060831 ANDA ANDA074260 American Health Packaging CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 68084-097_cbb36391-3522-4ef2-a5bb-8e93a765adb8 68084-097 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130709 ANDA ANDA090548 American Health Packaging ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-098_cbb36391-3522-4ef2-a5bb-8e93a765adb8 68084-098 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130709 ANDA ANDA090548 American Health Packaging ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-099_cbb36391-3522-4ef2-a5bb-8e93a765adb8 68084-099 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130709 ANDA ANDA090548 American Health Packaging ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-100_8405318a-b8f2-4905-a89d-9500b1807dd0 68084-100 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130625 20161006 ANDA ANDA040148 American Health Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 68084-101_ec81c914-34b5-4fef-88be-4bc6b1185d05 68084-101 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20131210 ANDA ANDA078619 American Health Packaging FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-103_ba039e48-7bde-4fc5-bd39-8c9dfa98fada 68084-103 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20141204 ANDA ANDA077561 American Health Packaging ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 68084-104_ba039e48-7bde-4fc5-bd39-8c9dfa98fada 68084-104 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20141204 ANDA ANDA077561 American Health Packaging ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 68084-105_ba039e48-7bde-4fc5-bd39-8c9dfa98fada 68084-105 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20141204 ANDA ANDA077561 American Health Packaging ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 68084-106_ba039e48-7bde-4fc5-bd39-8c9dfa98fada 68084-106 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20141204 ANDA ANDA077561 American Health Packaging ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 68084-107_9d16ea0c-5b51-43b8-bf1a-bee84a6a764b 68084-107 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20140129 ANDA ANDA075677 American Health Packaging ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68084-108_70038a69-badc-4073-a13e-ebc9bb8146bc 68084-108 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140129 ANDA ANDA077309 American Health Packaging ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68084-109_70038a69-badc-4073-a13e-ebc9bb8146bc 68084-109 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140129 ANDA ANDA077309 American Health Packaging ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68084-110_c91b3369-9646-4be6-9a7e-42abf7dc715d 68084-110 HUMAN PRESCRIPTION DRUG bethanechol chloride bethanechol chloride TABLET ORAL 20070220 ANDA ANDA040534 American Health Packaging BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 68084-111_f006b29a-4549-4787-8936-34c878f42649 68084-111 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080609 ANDA ANDA076467 American Health Packaging GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68084-112_f006b29a-4549-4787-8936-34c878f42649 68084-112 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080609 ANDA ANDA076467 American Health Packaging GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68084-119_dfeb6d93-c280-430d-b45c-84ebebbb84f3 68084-119 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20051031 ANDA ANDA076921 American Health Packaging MIRTAZAPINE 15 mg/1 68084-120_dfeb6d93-c280-430d-b45c-84ebebbb84f3 68084-120 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20051031 ANDA ANDA076921 American Health Packaging MIRTAZAPINE 30 mg/1 68084-121_dfeb6d93-c280-430d-b45c-84ebebbb84f3 68084-121 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20051221 ANDA ANDA076921 American Health Packaging MIRTAZAPINE 45 mg/1 68084-122_e3641eac-d900-4b27-9436-fde708da427d 68084-122 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20070802 ANDA ANDA077662 American Health Packaging GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-123_e3641eac-d900-4b27-9436-fde708da427d 68084-123 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20070813 ANDA ANDA077662 American Health Packaging GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-124_6bcbc9f1-43a5-4110-9d12-b0fcfa62f0dc 68084-124 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20131216 ANDA ANDA072192 American Health Packaging TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 68084-125_6bcbc9f1-43a5-4110-9d12-b0fcfa62f0dc 68084-125 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20131216 ANDA ANDA072193 American Health Packaging TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 68084-126_d92a09ae-017e-487c-bbd7-b284dce406ee 68084-126 HUMAN PRESCRIPTION DRUG Nephrocaps Ascorbic Acid, Folic Acid, Niacin, Thiamine, Riboflavin, Pyridoxine, Cyanocobalamin, Pantothenic Acid, Biotin CAPSULE, LIQUID FILLED ORAL 20130828 UNAPPROVED DRUG OTHER American Health Packaging ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; THIAMINE 100; 150; 6; 1; 20; 5; 10; 1.7; 1.5 mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 68084-127_d6f4dd14-f67a-4fe3-b356-02096c3e338a 68084-127 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20130930 ANDA ANDA091305 American Health Packaging NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68084-128_5e9364c6-6fe1-4c7f-af32-6592c58c1a6c 68084-128 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20091207 ANDA ANDA075576 American Health Packaging OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68084-129_2a849f8b-84fd-4564-9665-9a32c08fdb01 68084-129 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20110308 ANDA ANDA075133 American Health Packaging LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-135_6aeb78ea-1d73-4d27-bedc-9a19f3bcccb2 68084-135 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20131218 ANDA ANDA203399 American Health Packaging METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68084-149_a6406459-a1cc-41f6-b7cb-87daf86bdc8e 68084-149 HUMAN PRESCRIPTION DRUG MethylPREDNISolone methylprednisolone TABLET ORAL 20131125 ANDA ANDA040183 American Health Packaging METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68084-150_24c3b88a-8839-40e5-83c0-07224e42c8f2 68084-150 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20061130 ANDA ANDA077094 American Health Packaging RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 68084-154_f6c624f4-89cf-46bb-a36c-963d671e0f2e 68084-154 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20130719 ANDA ANDA040596 American Health Packaging PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68084-155_f6c624f4-89cf-46bb-a36c-963d671e0f2e 68084-155 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20130719 ANDA ANDA040596 American Health Packaging PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68084-157_a35f34bc-186a-4270-a78c-0430d8605477 68084-157 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130621 ANDA ANDA074862 American Health Packaging MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68084-158_a35f34bc-186a-4270-a78c-0430d8605477 68084-158 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130621 ANDA ANDA074862 American Health Packaging MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68084-159_a35f34bc-186a-4270-a78c-0430d8605477 68084-159 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130621 ANDA ANDA074862 American Health Packaging MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68084-160_a35f34bc-186a-4270-a78c-0430d8605477 68084-160 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130621 ANDA ANDA074769 American Health Packaging MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68084-166_c91b3369-9646-4be6-9a7e-42abf7dc715d 68084-166 HUMAN PRESCRIPTION DRUG bethanechol chloride bethanechol chloride TABLET ORAL 20070220 ANDA ANDA040533 American Health Packaging BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] 68084-172_0eef69c8-a0b6-47e2-b2ed-2c67e9fb7676 68084-172 HUMAN PRESCRIPTION DRUG FAMOTIDINE FAMOTIDINE TABLET ORAL 20130705 ANDA ANDA090837 American Health Packaging FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68084-174_f47df011-74a3-4fbd-a1c2-9caa002a90e4 68084-174 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20100907 ANDA ANDA078292 American Health Packaging DRONABINOL 2.5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 68084-175_f47df011-74a3-4fbd-a1c2-9caa002a90e4 68084-175 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20100907 ANDA ANDA078292 American Health Packaging DRONABINOL 5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII 68084-177_13205ebb-2a2d-4e4d-99e9-3d3d66b71a33 68084-177 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20100114 ANDA ANDA065433 American Health Packaging MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 68084-178_13205ebb-2a2d-4e4d-99e9-3d3d66b71a33 68084-178 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET ORAL 20100114 ANDA ANDA065477 American Health Packaging MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 68084-179_3999b25c-097c-4b15-a6b4-40e730cfef81 68084-179 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin CAPSULE ORAL 20061130 ANDA ANDA077224 American Health Packaging RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 68084-180_ea049814-c0fa-49f0-a8b3-de168700c886 68084-180 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20101216 ANDA ANDA077397 American Health Packaging SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-181_ea049814-c0fa-49f0-a8b3-de168700c886 68084-181 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20110406 ANDA ANDA077397 American Health Packaging SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-182_ea049814-c0fa-49f0-a8b3-de168700c886 68084-182 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20101215 ANDA ANDA077397 American Health Packaging SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-183_43a091e8-00b7-478e-843c-354a846fc3ab 68084-183 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20091210 ANDA ANDA077651 American Health Packaging ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-184_8c3e312d-c7e7-49f2-9e6c-776f3a387d86 68084-184 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20100115 ANDA ANDA076636 American Health Packaging OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 68084-185_8c3e312d-c7e7-49f2-9e6c-776f3a387d86 68084-185 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20100115 ANDA ANDA076636 American Health Packaging OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 68084-189_752c0ee4-5bb8-4316-9e9d-e6e6802797ba 68084-189 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, COATED ORAL 20140107 ANDA ANDA077322 American Health Packaging ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 68084-190_43a091e8-00b7-478e-843c-354a846fc3ab 68084-190 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20091210 ANDA ANDA077651 American Health Packaging ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-195_b9ff238b-1e7c-4663-aa70-81425d0ced9e 68084-195 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20140120 ANDA ANDA090429 American Health Packaging ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68084-196_c9490e6e-c186-4a1b-9c92-dca5023e74f1 68084-196 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131223 ANDA ANDA077321 American Health Packaging LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-197_c9490e6e-c186-4a1b-9c92-dca5023e74f1 68084-197 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131223 ANDA ANDA077321 American Health Packaging LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-198_c9490e6e-c186-4a1b-9c92-dca5023e74f1 68084-198 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131223 ANDA ANDA077321 American Health Packaging LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-199_c9490e6e-c186-4a1b-9c92-dca5023e74f1 68084-199 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131223 ANDA ANDA077321 American Health Packaging LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-200_752c0ee4-5bb8-4316-9e9d-e6e6802797ba 68084-200 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, COATED ORAL 20140107 ANDA ANDA077322 American Health Packaging ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 68084-201_b9ff238b-1e7c-4663-aa70-81425d0ced9e 68084-201 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20140120 ANDA ANDA090429 American Health Packaging ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68084-202_afb6f0dd-dd1a-4e1c-bd23-06159add7641 68084-202 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20070614 ANDA ANDA084903 American Health Packaging PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-203_afb6f0dd-dd1a-4e1c-bd23-06159add7641 68084-203 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20070614 ANDA ANDA084903 American Health Packaging PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-204_60f7b19f-6a84-4eb9-b02d-8d067579c4d4 68084-204 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 20070730 ANDA ANDA071826 American Health Packaging MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 68084-205_60f7b19f-6a84-4eb9-b02d-8d067579c4d4 68084-205 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 20070730 ANDA ANDA071839 American Health Packaging MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 68084-206_ce56049c-388f-4953-bab3-6a137c50f04f 68084-206 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20100414 ANDA ANDA040750 American Health Packaging SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 68084-207_ce56049c-388f-4953-bab3-6a137c50f04f 68084-207 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20110610 ANDA ANDA040750 American Health Packaging SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 68084-208_ce56049c-388f-4953-bab3-6a137c50f04f 68084-208 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20110610 ANDA ANDA040750 American Health Packaging SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 68084-213_8557f6f0-c798-478b-ae8c-9f7b34d84af5 68084-213 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20091105 NDA NDA019594 American Health Packaging URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 68084-214_9a71725a-64b6-4800-a79c-aa4b2d74d44f 68084-214 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20111003 ANDA ANDA040597 American Health Packaging BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 68084-215_23fb4162-2310-486c-ba9f-f7c94b793e56 68084-215 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20140228 ANDA ANDA090682 American Health Packaging VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68084-216_82a2043b-6287-462d-a7a8-0b177ffdb173 68084-216 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20140120 ANDA ANDA070035 Amerincan Health Packaging METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 68084-217_9a9e74f6-f6bd-4b30-87dc-036cb3224d44 68084-217 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20141215 ANDA ANDA202910 American Health Packaging IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68084-220_3d24ed55-336b-4143-bb37-817e147591bb 68084-220 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20120501 ANDA ANDA078539 American Health Packaging ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68084-221_3d24ed55-336b-4143-bb37-817e147591bb 68084-221 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20120501 ANDA ANDA078539 American Health Packaging ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68084-225_2a5c9a51-29de-4f83-b02e-98774d8a69e4 68084-225 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET ORAL 20091014 ANDA ANDA078426 American Health Packaging ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 68084-226_2a5c9a51-29de-4f83-b02e-98774d8a69e4 68084-226 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET ORAL 20091014 ANDA ANDA078426 American Health Packaging ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 68084-227_269345eb-4e9b-423c-83d9-2def768fe942 68084-227 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20091215 20161006 ANDA ANDA076642 American Health Packaging HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII 68084-229_4e27c381-4ec8-4965-8e1c-8bcaa4e62a44 68084-229 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20080222 ANDA ANDA077621 American Health Packaging AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 68084-230_65057096-1df9-4cb8-829e-8c8bec006d60 68084-230 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20130626 ANDA ANDA076899 American Health Packaging SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 68084-235_de69eafe-b9d3-4dd3-915d-ff2edafc14f4 68084-235 HUMAN PRESCRIPTION DRUG Amoxicillin and Calvulanate Potassium Amoxicillin and Clavulanate Potassium TABLET ORAL 20091211 ANDA ANDA065109 American Health Packaging AMOXICILLIN; CLAVULANIC ACID 500; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 68084-236_de69eafe-b9d3-4dd3-915d-ff2edafc14f4 68084-236 HUMAN PRESCRIPTION DRUG Amoxicillin and Calvulanate Potassium Amoxicillin and Clavulanate Potassium TABLET ORAL 20091211 ANDA ANDA065109 American Health Packaging AMOXICILLIN; CLAVULANIC ACID 875; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 68084-240_9bcaa0b3-86df-4698-be10-896aca698142 68084-240 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20100511 ANDA ANDA076514 American Health Packaging MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 68084-241_9bcaa0b3-86df-4698-be10-896aca698142 68084-241 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20100511 ANDA ANDA076514 American Health Packaging MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 68084-243_7e6c8170-d9f1-4f95-8fd3-ac64e5679dbb 68084-243 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20080422 ANDA ANDA065061 American Health Packaging CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 68084-244_7e6c8170-d9f1-4f95-8fd3-ac64e5679dbb 68084-244 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20080422 ANDA ANDA065061 American Health Packaging CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 68084-248_3ac9b0b2-50a3-48b3-8048-e8e9312e0b4c 68084-248 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20130614 UNAPPROVED DRUG OTHER American Health Packaging LORATADINE 10 mg/1 68084-249_828a617a-79ac-41e3-9ad2-ce5251d5d418 68084-249 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080304 ANDA ANDA077580 American Health Packaging HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] 68084-250_828a617a-79ac-41e3-9ad2-ce5251d5d418 68084-250 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080402 ANDA ANDA077580 American Health Packaging HALOPERIDOL 20 mg/1 Typical Antipsychotic [EPC] 68084-251_d02d39ef-fc9e-4096-bfaf-da51fba4d8b1 68084-251 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141105 ANDA ANDA077285 American Health Packaging BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68084-252_46199d76-9470-4c63-ab27-ee6e00bc5b48 68084-252 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130620 ANDA ANDA077284 American Health Packaging BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68084-253_6d0ed378-4805-4343-a40f-4f6e89163174 68084-253 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20090113 ANDA ANDA040786 American Health Packaging HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 68084-254_6d0ed378-4805-4343-a40f-4f6e89163174 68084-254 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20090113 ANDA ANDA040787 American Health Packaging HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 68084-255_6d0ed378-4805-4343-a40f-4f6e89163174 68084-255 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20090113 ANDA ANDA040788 American Health Packaging HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 68084-256_eb828a02-51f2-4f60-b7cd-c29a6a1aaf39 68084-256 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate TABLET ORAL 20080312 ANDA ANDA077152 American Health Packaging TERBUTALINE SULFATE 2.5 mg/1 68084-257_eb828a02-51f2-4f60-b7cd-c29a6a1aaf39 68084-257 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate TABLET ORAL 20080312 ANDA ANDA077152 American Health Packaging TERBUTALINE SULFATE 5 mg/1 68084-258_7b37c4c5-d2d3-44fe-9024-dc2c04f78555 68084-258 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140203 ANDA ANDA077955 American Health Packaging AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68084-259_7b37c4c5-d2d3-44fe-9024-dc2c04f78555 68084-259 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140203 ANDA ANDA077955 American Health Packaging AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68084-260_7b37c4c5-d2d3-44fe-9024-dc2c04f78555 68084-260 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140203 ANDA ANDA077955 American Health Packaging AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68084-261_f97c5b65-4458-47bc-b85f-27bb369f1013 68084-261 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20080703 ANDA ANDA077614 American Health Packaging CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68084-262_f97c5b65-4458-47bc-b85f-27bb369f1013 68084-262 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20080703 ANDA ANDA077614 American Health Packaging CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68084-263_f97c5b65-4458-47bc-b85f-27bb369f1013 68084-263 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20080703 ANDA ANDA077614 American Health Packaging CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68084-264_f97c5b65-4458-47bc-b85f-27bb369f1013 68084-264 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20080703 ANDA ANDA077614 American Health Packaging CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68084-266_c2af142a-e0d4-4d3b-af58-cf69f462d835 68084-266 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20080122 ANDA ANDA076549 American Health Packaging RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-267_c2af142a-e0d4-4d3b-af58-cf69f462d835 68084-267 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20080122 ANDA ANDA076549 American Health Packaging RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-268_c2af142a-e0d4-4d3b-af58-cf69f462d835 68084-268 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20080122 ANDA ANDA076549 American Health Packaging RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-269_ca1f9b0f-fcb3-43dc-81d7-15ff544f2b1d 68084-269 HUMAN PRESCRIPTION DRUG Hydroxychloroquine sulfate Hydroxychloroquine sulfate TABLET, FILM COATED ORAL 20080805 ANDA ANDA040657 American Health Packaging HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 68084-270_27f89aba-8767-46c9-acbf-45cecbbee88d 68084-270 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 American Health Packaging RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 68084-271_27f89aba-8767-46c9-acbf-45cecbbee88d 68084-271 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 American Health Packaging RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 68084-272_27f89aba-8767-46c9-acbf-45cecbbee88d 68084-272 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 American Health Packaging RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 68084-273_27f89aba-8767-46c9-acbf-45cecbbee88d 68084-273 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 American Health Packaging RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 68084-274_27f89aba-8767-46c9-acbf-45cecbbee88d 68084-274 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 American Health Packaging RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 68084-275_03cd3cc8-0214-4624-8571-b45e9e3522ab 68084-275 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20130614 ANDA ANDA040411 American Health Packaging METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 68084-276_03cd3cc8-0214-4624-8571-b45e9e3522ab 68084-276 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20130614 ANDA ANDA040411 American Health Packaging METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 68084-277_27f89aba-8767-46c9-acbf-45cecbbee88d 68084-277 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 American Health Packaging RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 68084-278_14ed41da-9719-40cd-8967-7aa280013610 68084-278 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20130719 ANDA ANDA065404 American Health Packaging AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68084-279_14ed41da-9719-40cd-8967-7aa280013610 68084-279 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20130719 ANDA ANDA065404 American Health Packaging AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68084-280_d32e9865-8edd-4644-9939-62ed119db3ef 68084-280 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET ORAL 20100114 ANDA ANDA078939 American Health Packaging ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] 68084-281_a8855b15-e995-4782-a0b8-b563e9c0a3a4 68084-281 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20130712 ANDA ANDA077828 American Health Packaging CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 68084-282_a8855b15-e995-4782-a0b8-b563e9c0a3a4 68084-282 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20130712 ANDA ANDA077828 American Health Packaging CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 68084-283_3a8352f0-569d-4d7e-b42a-392feb9e31a5 68084-283 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20110207 ANDA ANDA077058 American Health Packaging PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68084-284_1861b97c-ef26-4eac-ac4b-fee643450cf7 68084-284 HUMAN PRESCRIPTION DRUG Hydroxyurea Hydroxyurea CAPSULE ORAL 20080812 ANDA ANDA075340 American Health Packaging HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] 68084-286_00fc4909-d33f-4e73-a63d-10058624915b 68084-286 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET ORAL 20091209 ANDA ANDA076502 American Health Packaging FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 68084-287_00fc4909-d33f-4e73-a63d-10058624915b 68084-287 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET ORAL 20091209 ANDA ANDA076502 American Health Packaging FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 68084-288_001e72ea-2c9e-468c-90cc-6c347234e2a9 68084-288 HUMAN PRESCRIPTION DRUG Fludrocortisone Acetate Fludrocortisone Acetate TABLET ORAL 20080509 ANDA ANDA040431 American Health Packaging FLUDROCORTISONE ACETATE .1 mg/1 68084-289_8c7c9d05-8cdb-4c00-9809-aa10ec613967 68084-289 HUMAN PRESCRIPTION DRUG MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE ORAL 20080827 ANDA ANDA065005 American Health Packaging MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 68084-291_a8e1e7e8-45ee-41de-af32-9a3f8332ca19 68084-291 HUMAN PRESCRIPTION DRUG NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET, FILM COATED ORAL 20120102 ANDA ANDA076264 American Health Packaging NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] 68084-292_24220035-37fe-4d90-aae6-f8963fb77fa9 68084-292 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20130624 UNAPPROVED DRUG OTHER American Health Packaging PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 68084-293_24220035-37fe-4d90-aae6-f8963fb77fa9 68084-293 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20130624 UNAPPROVED DRUG OTHER American Health Packaging PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 68084-294_c2af142a-e0d4-4d3b-af58-cf69f462d835 68084-294 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20080609 ANDA ANDA076549 American Health Packaging RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-295_f006b29a-4549-4787-8936-34c878f42649 68084-295 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081030 ANDA ANDA076467 American Health Packaging GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68084-299_8150a710-aee5-4841-ae1b-7d2e61281a8f 68084-299 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20140117 ANDA ANDA078225 American Health Packaging TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68084-300_b243682b-78be-4c16-a172-3d631a2c09f1 68084-300 HUMAN PRESCRIPTION DRUG Dantrolene Sodium Dantrolene Sodium CAPSULE ORAL 20080925 ANDA ANDA076856 American Health Packaging DANTROLENE SODIUM 25 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] 68084-301_7e54c03b-27aa-4006-9e4a-2a2b8800f6ce 68084-301 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100813 ANDA ANDA090615 American Health Packaging METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-302_7e54c03b-27aa-4006-9e4a-2a2b8800f6ce 68084-302 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100813 ANDA ANDA090615 American Health Packaging METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-303_7e54c03b-27aa-4006-9e4a-2a2b8800f6ce 68084-303 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100813 ANDA ANDA090615 American Health Packaging METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-304_7e54c03b-27aa-4006-9e4a-2a2b8800f6ce 68084-304 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100813 ANDA ANDA090615 American Health Packaging METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-305_71704334-a1c7-42dc-bfc8-e9cebb02a726 68084-305 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20130705 ANDA ANDA079050 American Health Packaging ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68084-306_71704334-a1c7-42dc-bfc8-e9cebb02a726 68084-306 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20130705 ANDA ANDA079050 American Health Packaging ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68084-307_71704334-a1c7-42dc-bfc8-e9cebb02a726 68084-307 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20130705 ANDA ANDA079050 American Health Packaging ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68084-308_71704334-a1c7-42dc-bfc8-e9cebb02a726 68084-308 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20130705 ANDA ANDA079050 American Health Packaging ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68084-309_23fb4162-2310-486c-ba9f-f7c94b793e56 68084-309 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20140228 ANDA ANDA090682 American Health Packaging VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68084-310_a8ba3986-1ded-44a8-8d10-d0f252a07794 68084-310 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131121 ANDA ANDA078239 American Health Packaging DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68084-311_b9ff238b-1e7c-4663-aa70-81425d0ced9e 68084-311 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20140120 ANDA ANDA090429 American Health Packaging ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68084-313_1c4ea059-ab57-41ab-90ab-fd50540028a4 68084-313 HUMAN PRESCRIPTION DRUG divalproex sodium divalproex sodium CAPSULE, COATED PELLETS ORAL 20090401 ANDA ANDA078919 American Health Packaging DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68084-314_9fef0f9c-e6ed-4b29-a473-525f2aba70bd 68084-314 HUMAN PRESCRIPTION DRUG Divalproex Sodium DR Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20091014 ANDA ANDA078790 American Health Packaging DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68084-315_9fef0f9c-e6ed-4b29-a473-525f2aba70bd 68084-315 HUMAN PRESCRIPTION DRUG Divalproex Sodium DR Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20091014 ANDA ANDA078790 American Health Packaging DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68084-316_3700405c-5743-4c82-a3fb-48dae904eed6 68084-316 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM EXTENDED-RELEASE DIVALPROEX SODIUM EXTENDED-RELEASE TABLET, EXTENDED RELEASE ORAL 20091014 ANDA ANDA078705 American Health Packaging DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68084-317_3700405c-5743-4c82-a3fb-48dae904eed6 68084-317 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM EXTENDED-RELEASE DIVALPROEX SODIUM EXTENDED-RELEASE TABLET, EXTENDED RELEASE ORAL 20091014 ANDA ANDA078705 American Health Packaging DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68084-318_a5983905-7b8c-4e1a-8c44-aa41eef07808 68084-318 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130705 ANDA ANDA077633 American Health Packaging LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68084-319_a5983905-7b8c-4e1a-8c44-aa41eef07808 68084-319 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130705 ANDA ANDA077633 American Health Packaging LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68084-320_a5983905-7b8c-4e1a-8c44-aa41eef07808 68084-320 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130705 ANDA ANDA077633 American Health Packaging LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68084-322_6add39ee-2c4d-4071-b160-8c38b43e86e0 68084-322 HUMAN PRESCRIPTION DRUG ALENDRONATE SODIUM ALENDRONATE SODIUM TABLET ORAL 20091104 ANDA ANDA076984 American Health Packaging ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 68084-325_f9419de3-5378-49a1-a99c-f47ac4a61094 68084-325 HUMAN PRESCRIPTION DRUG mercaptopurine mercaptopurine TABLET ORAL 20130315 ANDA ANDA040461 American Health Packaging MERCAPTOPURINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 68084-326_65216872-dc40-41bf-9c2d-ce39417113b2 68084-326 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20090512 ANDA ANDA077091 American Health Packaging GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68084-327_65216872-dc40-41bf-9c2d-ce39417113b2 68084-327 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20090512 ANDA ANDA077091 American Health Packaging GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68084-328_642550fb-839c-4b15-9d95-4dd9fff36ed5 68084-328 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20141020 ANDA ANDA076509 American Health Packaging FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68084-329_070e1734-84c9-407e-91bc-3f8c2946b46e 68084-329 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20141001 ANDA ANDA075868 American Health Packaging FENOFIBRATE 200 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68084-330_d94ad2c8-dc26-4d3d-b6a0-0d7069d890b5 68084-330 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20090113 ANDA ANDA077653 American Health Packaging VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-331_d94ad2c8-dc26-4d3d-b6a0-0d7069d890b5 68084-331 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20090113 ANDA ANDA077653 American Health Packaging VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-332_b9ff238b-1e7c-4663-aa70-81425d0ced9e 68084-332 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20140120 ANDA ANDA090429 American Health Packaging ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68084-333_55bfb3b3-dc73-4e16-833f-b04a163ea96d 68084-333 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20090402 ANDA ANDA077863 American Health Packaging DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68084-335_fc158f5c-4e60-44b8-adba-fbcbc6e734ec 68084-335 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET, CHEWABLE ORAL 20110617 ANDA ANDA076928 American Health Packaging LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68084-336_4671df2f-7481-4d1b-90eb-10d1e6e7a8c4 68084-336 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20100128 ANDA ANDA078154 American Health Packaging LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-337_4671df2f-7481-4d1b-90eb-10d1e6e7a8c4 68084-337 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20100128 ANDA ANDA078154 American Health Packaging LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-338_4671df2f-7481-4d1b-90eb-10d1e6e7a8c4 68084-338 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120402 ANDA ANDA078154 American Health Packaging LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-339_3b517e0e-7848-418c-8599-fce46f3bedcd 68084-339 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET, COATED ORAL 20130705 ANDA ANDA076933 American Health Packaging SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68084-340_3b517e0e-7848-418c-8599-fce46f3bedcd 68084-340 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET, COATED ORAL 20130705 ANDA ANDA076933 American Health Packaging SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68084-341_3b517e0e-7848-418c-8599-fce46f3bedcd 68084-341 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET, COATED ORAL 20130705 ANDA ANDA076933 American Health Packaging SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68084-342_fae90a53-23a8-4b91-9f8a-cc4971f4120d 68084-342 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20120601 ANDA ANDA078235 American Health Packaging TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-343_fae90a53-23a8-4b91-9f8a-cc4971f4120d 68084-343 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20120601 20150327 ANDA ANDA078235 American Health Packaging TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-344_fae90a53-23a8-4b91-9f8a-cc4971f4120d 68084-344 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20120601 ANDA ANDA078235 American Health Packaging TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-345_fae90a53-23a8-4b91-9f8a-cc4971f4120d 68084-345 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20120601 ANDA ANDA078235 American Health Packaging TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-346_6936d50e-ff58-4279-8500-1da491da486d 68084-346 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20130613 ANDA ANDA078243 American Health Packaging LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68084-347_6936d50e-ff58-4279-8500-1da491da486d 68084-347 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20130613 ANDA ANDA078243 American Health Packaging LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68084-348_6936d50e-ff58-4279-8500-1da491da486d 68084-348 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20130613 ANDA ANDA078243 American Health Packaging LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68084-349_6d84c3fd-697f-4bc2-aa18-d7a9adcc9ca8 68084-349 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril HCL Amlodipine Besylate and Benazepril HCL CAPSULE ORAL 20100922 ANDA ANDA078466 American Health Packaging AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68084-350_6d84c3fd-697f-4bc2-aa18-d7a9adcc9ca8 68084-350 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril HCL Amlodipine Besylate and Benazepril HCL CAPSULE ORAL 20100922 ANDA ANDA078466 American Health Packaging AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68084-351_6d84c3fd-697f-4bc2-aa18-d7a9adcc9ca8 68084-351 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril HCL Amlodipine Besylate and Benazepril HCL CAPSULE ORAL 20100922 ANDA ANDA078466 American Health Packaging AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68084-354_aa7ac2bf-d9ed-445d-b394-4d3fe39780ca 68084-354 HUMAN PRESCRIPTION DRUG Oxycodone Hydchloride Oxycodone Hydrochloride TABLET ORAL 20091209 ANDA ANDA091393 American Health Packaging OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68084-355_b5d50907-864c-4bb1-bc80-09ecbacd1818 68084-355 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20090923 ANDA ANDA040777 American Health Packaging ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68084-356_cda0475c-3b86-4328-b8f6-a99a6a2ebc14 68084-356 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101229 ANDA ANDA090025 American Health Packaging LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-357_19ee9e18-d437-4bb2-9ad8-75c8f283a2df 68084-357 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20090925 ANDA ANDA065390 American Health Packaging RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 68084-358_19ee9e18-d437-4bb2-9ad8-75c8f283a2df 68084-358 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20090925 ANDA ANDA065390 American Health Packaging RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 68084-359_1d1e0f1b-902e-45d6-b50a-12aadd462da5 68084-359 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20091013 ANDA ANDA071135 American Health Packaging DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-360_3171e688-3a7f-4b00-a4f4-99b15a51cde3 68084-360 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20100121 ANDA ANDA076368 American Health Packaging POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68084-361_8c0b74de-bddc-4fbc-bfd0-22ed95ced524 68084-361 HUMAN PRESCRIPTION DRUG Propafenone HCl Propafenone hydrochloride TABLET, FILM COATED ORAL 20120501 ANDA ANDA075203 American Health Packaging PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] 68084-364_82a2043b-6287-462d-a7a8-0b177ffdb173 68084-364 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20140120 ANDA ANDA070044 Amerincan Health Packaging METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 68084-366_ff4b326d-a55d-4f9b-92d4-ed555fbf2454 68084-366 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20140923 ANDA ANDA078556 American Health Packaging DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 68084-368_78819fa3-5953-4917-b524-2a9268ecbb99 68084-368 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20090922 20161006 ANDA ANDA040736 American Health Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 68084-371_e6a8ed4f-a343-42d7-a35e-8ad820f3da23 68084-371 HUMAN PRESCRIPTION DRUG AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET ORAL 20090925 ANDA ANDA079029 American Health Packaging AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 68084-372_8e68de4c-3d6d-479a-b730-9ff43ab948f4 68084-372 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine Phosphate acetaminophen and codeine phosphate TABLET ORAL 20100113 ANDA ANDA089805 American Health Packaging ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 68084-373_8e68de4c-3d6d-479a-b730-9ff43ab948f4 68084-373 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine Phosphate acetaminophen and codeine phosphate TABLET ORAL 20100113 ANDA ANDA089828 American Health Packaging ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 68084-374_acb15f19-762d-497b-9b01-38ff60c4314d 68084-374 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20100113 ANDA ANDA079089 American Health Packaging BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 68084-375_f85296ab-a104-496f-a23d-e0a88cf91ec7 68084-375 HUMAN PRESCRIPTION DRUG Bromocriptine Mesylate Bromocriptine Mesylate CAPSULE ORAL 20100113 ANDA ANDA078899 American Health Packaging BROMOCRIPTINE MESYLATE 5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 68084-376_8ca43d7a-aff0-4a22-ba4b-f2b21cad4188 68084-376 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE ORAL 20130719 ANDA ANDA040765 American Health Packaging PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-378_8646a797-7a70-463b-aafa-a835b3e381d0 68084-378 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20090925 ANDA ANDA040535 American Health Packaging ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68084-379_8646a797-7a70-463b-aafa-a835b3e381d0 68084-379 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20090925 ANDA ANDA040535 American Health Packaging ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68084-380_62096762-af2d-4025-9386-a6b45ca25737 68084-380 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20100115 ANDA ANDA040245 American Health Packaging CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 68084-381_82d4396f-91c3-4c46-8e3b-7e8b254a746b 68084-381 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20100114 ANDA ANDA040738 American Health Packaging BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 68084-388_82d4396f-91c3-4c46-8e3b-7e8b254a746b 68084-388 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20100114 ANDA ANDA040742 American Health Packaging BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 68084-389_82d4396f-91c3-4c46-8e3b-7e8b254a746b 68084-389 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20100114 ANDA ANDA040715 American Health Packaging BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 68084-390_08f90170-f53c-4272-92ae-951cf115e271 68084-390 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20090526 ANDA ANDA075483 American Health Packaging ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68084-391_08f90170-f53c-4272-92ae-951cf115e271 68084-391 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20090526 ANDA ANDA075483 American Health Packaging ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68084-392_08f90170-f53c-4272-92ae-951cf115e271 68084-392 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20090526 ANDA ANDA075483 American Health Packaging ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68084-393_107e852d-500a-4c7a-b5ff-78e3b0f17a91 68084-393 HUMAN PRESCRIPTION DRUG PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN propoxyphene napsylate and acetaminophen TABLET ORAL 20090925 ANDA ANDA074843 American Health Packaging ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 650; 100 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68084-396_d473f34f-c3d7-4772-ae21-2aae6dc25729 68084-396 HUMAN PRESCRIPTION DRUG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET ORAL 20120601 ANDA ANDA040511 American Health Packaging ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 68084-397_14cc23fe-9ea0-4118-ab76-cfa1e9705401 68084-397 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20091014 ANDA ANDA077797 American Health Packaging CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68084-398_08fc1bae-4196-4cb0-89c9-e99599c61556 68084-398 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20130708 ANDA ANDA075907 American Health Packaging HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68084-399_80a1dd88-3880-45a6-87bf-520dadd96294 68084-399 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20120217 ANDA ANDA077914 American Health Packaging FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 68084-400_248ab64b-358e-4b59-bd6c-3d1a6b633fcc 68084-400 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 20100113 ANDA ANDA075079 American Health Packaging OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 68084-401_7c9ac4b0-fcac-483e-aaa4-43e76faaa4b7 68084-401 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide CAPSULE, EXTENDED RELEASE ORAL 20100414 ANDA ANDA040904 American Health Packaging ACETAZOLAMIDE 500 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 68084-407_b07f23d8-97ec-4a50-984a-b7dea69f9705 68084-407 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20101007 ANDA ANDA078938 American Health Packaging TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68084-408_1837c22b-f066-470a-95a7-9b1274d0bd14 68084-408 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET ORAL 20100621 ANDA ANDA076588 American Health Packaging VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68084-409_1837c22b-f066-470a-95a7-9b1274d0bd14 68084-409 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET ORAL 20100621 ANDA ANDA076588 American Health Packaging VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68084-411_79ca69d5-7e5d-4303-8f4e-321b0bed131e 68084-411 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20100326 ANDA ANDA079175 American Health Packaging INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68084-412_f0db00dd-d63e-4111-aec2-240304acc71a 68084-412 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20130619 ANDA ANDA071403 American Health Packaging LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-413_f0db00dd-d63e-4111-aec2-240304acc71a 68084-413 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20130619 ANDA ANDA071404 American Health Packaging LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-414_f0db00dd-d63e-4111-aec2-240304acc71a 68084-414 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20130619 ANDA ANDA071141 American Health Packaging LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-415_a8ba3986-1ded-44a8-8d10-d0f252a07794 68084-415 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131121 ANDA ANDA078239 American Health Packaging DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68084-416_d9370dfc-283b-4a91-8e5e-18c35d2a78e6 68084-416 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20140220 ANDA ANDA202418 American Health Packaging LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 68084-417_34868f95-78d0-4089-8cbd-bec1cb730eda 68084-417 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20101004 ANDA ANDA076732 American Health Packaging METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 68084-418_34868f95-78d0-4089-8cbd-bec1cb730eda 68084-418 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20101004 ANDA ANDA076466 American Health Packaging METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 68084-419_4b06f42e-d61e-406a-ac32-370b2967dd64 68084-419 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20120702 NDA AUTHORIZED GENERIC NDA018238 American Health Packaging POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68084-420_8e86b2c6-b449-4abc-97fb-e78702bb1b83 68084-420 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET ORAL 20100528 ANDA ANDA080439 American Health Packaging CHLORPROMAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68084-421_8e86b2c6-b449-4abc-97fb-e78702bb1b83 68084-421 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET ORAL 20100528 ANDA ANDA080439 American Health Packaging CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68084-422_8e86b2c6-b449-4abc-97fb-e78702bb1b83 68084-422 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET ORAL 20100528 ANDA ANDA080439 American Health Packaging CHLORPROMAZINE HYDROCHLORIDE 200 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68084-423_fc7470cc-95aa-49c0-af23-ee7393f82280 68084-423 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20130717 ANDA ANDA078439 American Health Packaging HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68084-424_b3d24364-f4fc-4aac-ac5c-651ae7f6f9b6 68084-424 HUMAN PRESCRIPTION DRUG Oxandrolone oxandrolone TABLET ORAL 20130624 ANDA ANDA077827 American Health Packaging OXANDROLONE 2.5 mg/1 CIII 68084-430_11a432b9-2374-4bdc-ac9b-9f45fb942905 68084-430 HUMAN OTC DRUG healthylax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20110201 ANDA ANDA090812 American Health Packaging POLYETHYLENE GLYCOL 3350 17 g/17g 68084-431_09aee1f2-d5f0-4544-9949-14e425219220 68084-431 HUMAN PRESCRIPTION DRUG DIDANOSINE DIDANOSINE CAPSULE, DELAYED RELEASE ORAL 20091208 ANDA ANDA077167 American Health Packaging DIDANOSINE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 68084-432_09aee1f2-d5f0-4544-9949-14e425219220 68084-432 HUMAN PRESCRIPTION DRUG DIDANOSINE DIDANOSINE CAPSULE, DELAYED RELEASE ORAL 20091208 ANDA ANDA077167 American Health Packaging DIDANOSINE 400 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 68084-435_7d7a0453-5216-49c0-8861-f28f10f13b1b 68084-435 HUMAN PRESCRIPTION DRUG Isosorbide mononitrate Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130708 ANDA ANDA076813 American Health Packaging ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68084-436_7d7a0453-5216-49c0-8861-f28f10f13b1b 68084-436 HUMAN PRESCRIPTION DRUG Isosorbide mononitrate Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130708 ANDA ANDA076813 American Health Packaging ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68084-437_e0631ff1-5b29-42d5-a07b-88ded6871201 68084-437 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20130620 ANDA ANDA065266 American Health Packaging CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68084-440_c6c20c9a-53ea-4584-8122-481d2962cfeb 68084-440 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20110501 ANDA ANDA078920 American Health Packaging PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68084-443_84629614-e14c-47c9-b642-c6aa8b431929 68084-443 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20100809 ANDA ANDA065404 American Health Packaging AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68084-444_1dd3d934-efee-4fdb-ae6f-f47b61831a2e 68084-444 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20140415 ANDA ANDA075948 American Health Packaging CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 68084-446_508b2795-d004-4678-9ff2-950b4bb27b8d 68084-446 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin (monohydrate/macrocrystals) CAPSULE ORAL 20101007 ANDA ANDA080043 American Health Packaging NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 68084-447_331dc218-2ef7-4735-9823-f84529b3bb06 68084-447 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100910 ANDA ANDA086242 American Health Packaging HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 68084-448_d1be67b7-61c0-4620-b877-17f7fae0a3b4 68084-448 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, COATED ORAL 20100627 ANDA ANDA078921 American Health Packaging ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 68084-449_61322a53-f4f6-40ad-84e8-7a85d7705a59 68084-449 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20130717 ANDA ANDA090509 American Health Packaging TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 68084-450_61322a53-f4f6-40ad-84e8-7a85d7705a59 68084-450 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20130717 ANDA ANDA090509 American Health Packaging TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 68084-451_61322a53-f4f6-40ad-84e8-7a85d7705a59 68084-451 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20130717 ANDA ANDA090509 American Health Packaging TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] 68084-456_2a849f8b-84fd-4564-9665-9a32c08fdb01 68084-456 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20110308 ANDA ANDA075133 American Health Packaging LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-457_2a849f8b-84fd-4564-9665-9a32c08fdb01 68084-457 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20110308 ANDA ANDA075133 American Health Packaging LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-458_047035e5-59c8-42eb-8a34-da63dcbbf09f 68084-458 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20120102 ANDA ANDA077463 American Health Packaging NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 68084-459_047035e5-59c8-42eb-8a34-da63dcbbf09f 68084-459 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20120102 ANDA ANDA077463 American Health Packaging NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 68084-461_24275018-b4b3-4778-bd4d-73de5e558714 68084-461 HUMAN PRESCRIPTION DRUG Zidovudine zidovudine CAPSULE ORAL 20130705 ANDA ANDA078128 American Health Packaging ZIDOVUDINE 100 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 68084-462_f4534f59-77b6-4a4c-ae64-efed3175ca90 68084-462 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20110103 ANDA ANDA077267 American Health Packaging ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 68084-463_820ad6a8-a5c7-4e3b-a6d0-bbf6c04bab56 68084-463 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20110107 ANDA ANDA040833 American Health Packaging ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 68084-464_62d24da1-2011-460d-a2f8-546049219070 68084-464 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20120702 ANDA ANDA065302 American Health Packaging AZITHROMYCIN ANHYDROUS 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68084-466_5e9364c6-6fe1-4c7f-af32-6592c58c1a6c 68084-466 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20091207 ANDA ANDA075576 American Health Packaging OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68084-467_4b3d430e-e439-4b59-b6d7-5da9b5d24b54 68084-467 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20100915 ANDA ANDA091269 American Health Packaging LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68084-468_4b3d430e-e439-4b59-b6d7-5da9b5d24b54 68084-468 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20100915 ANDA ANDA090763 American Health Packaging LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68084-469_41959de4-8732-43f9-9312-bcff4530c258 68084-469 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20110401 ANDA ANDA040761 American Health Packaging HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68084-470_55d53a9b-fc92-4acf-be34-7daf1a6f2570 68084-470 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110701 ANDA ANDA077455 American Health Packaging BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68084-471_55d53a9b-fc92-4acf-be34-7daf1a6f2570 68084-471 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110701 ANDA ANDA077455 American Health Packaging BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68084-472_fc7470cc-95aa-49c0-af23-ee7393f82280 68084-472 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20130717 ANDA ANDA078439 American Health Packaging HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68084-473_57688690-1ceb-4c4a-b9a0-f8389dedd38b 68084-473 HUMAN PRESCRIPTION DRUG GEMFIBROZIL GEMFIBROZIL TABLET, FILM COATED ORAL 20110601 ANDA ANDA074256 American Health Packaging GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68084-475_c5bf5233-605b-42d7-b9f8-fe29c63331c9 68084-475 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE ORAL 20120301 ANDA ANDA076917 American Health Packaging CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 68084-477_7889f006-4fcd-4d12-898c-8d20c54dd519 68084-477 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110301 ANDA ANDA076786 American Health Packaging DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68084-478_7889f006-4fcd-4d12-898c-8d20c54dd519 68084-478 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110301 ANDA ANDA076786 American Health Packaging DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68084-479_1090762c-eec1-4ab0-9ddc-43caa764cd0e 68084-479 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20130726 ANDA ANDA077728 American Health Packaging CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 68084-479_bb5785a3-ba5b-43b6-9c65-07c56766a3eb 68084-479 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20120827 ANDA ANDA077728 American Health Packaging CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 68084-480_8ade9de4-67ea-42ef-b576-ee517ca2acab 68084-480 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20120110 ANDA ANDA078503 American Health Packaging OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 68084-481_8e3d585c-25b9-4940-b309-82548b8d33cd 68084-481 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110701 ANDA ANDA078424 American Health Packaging LEVOFLOXACIN 250 mg/1 68084-482_8e3d585c-25b9-4940-b309-82548b8d33cd 68084-482 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110701 ANDA ANDA078424 American Health Packaging LEVOFLOXACIN 500 mg/1 68084-483_8e3d585c-25b9-4940-b309-82548b8d33cd 68084-483 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110701 ANDA ANDA078424 American Health Packaging LEVOFLOXACIN 750 mg/1 68084-484_1a5fd3dc-2f46-4884-95df-80b8a46c7e41 68084-484 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078865 American Health Packaging VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-485_1a5fd3dc-2f46-4884-95df-80b8a46c7e41 68084-485 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078865 American Health Packaging VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-486_1a5fd3dc-2f46-4884-95df-80b8a46c7e41 68084-486 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078865 American Health Packaging VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-487_7cf72e59-f83e-4d4d-a96a-820377eb3c66 68084-487 HUMAN PRESCRIPTION DRUG bisoprolol fumarate bisoprolol fumarate TABLET, COATED ORAL 20110801 ANDA ANDA075643 American Health Packaging BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-490_d85f2ccb-95b1-42f6-a4c0-12ac945ca099 68084-490 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20110701 ANDA ANDA201451 American Health Packaging MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 68084-491_d85f2ccb-95b1-42f6-a4c0-12ac945ca099 68084-491 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20110701 ANDA ANDA201451 American Health Packaging MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 68084-494_64ed79b7-9439-483c-9f56-07155a5d24d7 68084-494 HUMAN PRESCRIPTION DRUG Pyridostigmine Bromide PYRIDOSTIGMINE BROMIDE TABLET ORAL 20110930 ANDA ANDA040502 American Health Packaging PYRIDOSTIGMINE BROMIDE 60 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68084-497_9db6a76f-6745-4f26-8fb3-cbf6743a360c 68084-497 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20130612 ANDA ANDA075366 American Health Packaging SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 68084-498_0d1a3686-d8d7-43a3-b38d-df5e6cf71cfa 68084-498 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20130723 ANDA ANDA078500 American Health Packaging AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68084-499_b5650ad5-471d-4639-b8da-bdb3d990c627 68084-499 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20110901 ANDA ANDA040653 American Health Packaging GLYCOPYRROLATE 1 mg/1 68084-500_581f17c6-1d7d-4bf3-9ef7-537a222d0ac1 68084-500 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20111001 ANDA ANDA077751 American Health Packaging PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-501_581f17c6-1d7d-4bf3-9ef7-537a222d0ac1 68084-501 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20111001 ANDA ANDA077751 American Health Packaging PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-502_581f17c6-1d7d-4bf3-9ef7-537a222d0ac1 68084-502 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20111001 ANDA ANDA077751 American Health Packaging PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-503_0225559a-7788-4065-8a79-071d408b4c68 68084-503 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130705 NDA AUTHORIZED GENERIC NDA018553 American Health Packaging PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-504_0225559a-7788-4065-8a79-071d408b4c68 68084-504 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130705 NDA AUTHORIZED GENERIC NDA018553 American Health Packaging PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-505_0d1a3686-d8d7-43a3-b38d-df5e6cf71cfa 68084-505 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20130723 ANDA ANDA078500 American Health Packaging AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68084-506_0d1a3686-d8d7-43a3-b38d-df5e6cf71cfa 68084-506 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20130723 ANDA ANDA078500 American Health Packaging AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68084-508_2ac2f4ec-78a3-45c4-b2ad-056611df5ad2 68084-508 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20110701 ANDA ANDA077002 American Health Packaging DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 68084-509_2ac2f4ec-78a3-45c4-b2ad-056611df5ad2 68084-509 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20110701 ANDA ANDA077002 American Health Packaging DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 68084-510_1d2ff499-ad1a-42b7-80b1-40ac7b9dd391 68084-510 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20110502 ANDA ANDA078103 American Health Packaging SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-511_1d2ff499-ad1a-42b7-80b1-40ac7b9dd391 68084-511 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20110502 ANDA ANDA078103 American Health Packaging SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-512_1d2ff499-ad1a-42b7-80b1-40ac7b9dd391 68084-512 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20110502 ANDA ANDA078103 American Health Packaging SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-513_1d2ff499-ad1a-42b7-80b1-40ac7b9dd391 68084-513 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20110502 ANDA ANDA078103 American Health Packaging SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-514_1d2ff499-ad1a-42b7-80b1-40ac7b9dd391 68084-514 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20110502 ANDA ANDA078103 American Health Packaging SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-519_f5882b3b-f93b-4ebf-893a-22ff17315e08 68084-519 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20130612 ANDA ANDA077912 American Health Packaging HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-520_331dc218-2ef7-4735-9823-f84529b3bb06 68084-520 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20110919 ANDA ANDA086242 American Health Packaging HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 68084-521_776ccac6-471d-4c41-8c52-a8e90bd832c5 68084-521 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE ORAL 20120201 ANDA ANDA072781 American Health Packaging NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68084-523_6e495257-2c4a-484a-999a-5dae4dbe2a19 68084-523 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111201 ANDA ANDA078179 American Health Packaging ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 68084-524_981ca9d3-5dd4-46ab-a799-3506e7b89111 68084-524 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110913 NDA AUTHORIZED GENERIC NDA018279 American Health Packaging POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68084-525_aa688a7c-1e13-4c36-ba0f-2e5b5978f2a4 68084-525 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120501 ANDA ANDA076255 American Health Packaging OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 68084-526_aa688a7c-1e13-4c36-ba0f-2e5b5978f2a4 68084-526 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120501 20150930 ANDA ANDA076255 American Health Packaging OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 68084-527_aa688a7c-1e13-4c36-ba0f-2e5b5978f2a4 68084-527 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120501 20150930 ANDA ANDA076255 American Health Packaging OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 68084-528_c2c67375-9e7a-407f-be86-3fad7ec024ca 68084-528 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120201 ANDA ANDA076133 American Health Packaging OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 68084-529_c2c67375-9e7a-407f-be86-3fad7ec024ca 68084-529 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120201 ANDA ANDA076133 American Health Packaging OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] 68084-530_752fd16b-84c4-4cee-8eff-3e7ae47932cd 68084-530 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 American Health Packaging QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 68084-531_752fd16b-84c4-4cee-8eff-3e7ae47932cd 68084-531 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 American Health Packaging QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 68084-532_752fd16b-84c4-4cee-8eff-3e7ae47932cd 68084-532 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 American Health Packaging QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 68084-533_752fd16b-84c4-4cee-8eff-3e7ae47932cd 68084-533 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 American Health Packaging QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 68084-534_752fd16b-84c4-4cee-8eff-3e7ae47932cd 68084-534 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 American Health Packaging QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 68084-535_752fd16b-84c4-4cee-8eff-3e7ae47932cd 68084-535 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 American Health Packaging QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 68084-536_65ea4dc6-acb2-4609-9a4c-4866ef0ccb11 68084-536 HUMAN PRESCRIPTION DRUG Clopidogrel clopidogrel bisulfate TABLET, FILM COATED ORAL 20140314 ANDA ANDA076274 American Health Packaging CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 68084-537_01af55ee-a92f-4e67-a14f-3621da3ed3f5 68084-537 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20121128 ANDA ANDA202266 American Health Packaging CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 68084-538_5374a4cc-7b97-44aa-a41d-e8785fc06ef3 68084-538 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20120501 ANDA ANDA200265 American Health Packaging VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68084-539_93f183c7-d74a-456d-af20-937fae97d8dc 68084-539 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20130722 ANDA ANDA079234 American Health Packaging TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 68084-540_0904aa6b-c1cc-4137-87d0-d18ec6a69c54 68084-540 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20110714 ANDA ANDA075442 American Health Packaging FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] 68084-541_7bcb16ee-2233-462c-bf6f-4d55eecbed29 68084-541 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE Acetazolamide TABLET ORAL 20111101 ANDA ANDA084840 American Health Packaging ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 68084-542_09796ddd-64db-417d-9bfb-94b6300187a3 68084-542 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20101001 ANDA ANDA078671 American Health Packaging NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68084-548_60a860cb-b338-4a8a-938e-7b1e35ed697a 68084-548 HUMAN PRESCRIPTION DRUG Lithium Carbonate ER Lithium Carbonate TABLET ORAL 20120305 ANDA ANDA091616 American Health Packaging LITHIUM CARBONATE 450 mg/1 68084-549_96e5cd36-b10b-49ab-a867-91bd9a1b64ca 68084-549 HUMAN PRESCRIPTION DRUG TEMAZEPAM temazepam CAPSULE ORAL 20120201 NDA NDA018163 American Health Packaging TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-550_d2690b7a-94d7-42f9-acb5-9556f70fe364 68084-550 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20120106 ANDA ANDA077131 American Health Packaging RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68084-551_d80883d0-5469-4bde-8bcb-ed65127a7555 68084-551 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20120125 ANDA ANDA040591 American Health Packaging ISOSORBIDE DINITRATE 30 mg/1 68084-552_1b515565-a311-4d1a-a2ce-02b16bdb74a5 68084-552 HUMAN PRESCRIPTION DRUG Ketoconazole ketoconazole TABLET ORAL 20120120 ANDA ANDA075597 American Health Packaging KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68084-553_1bf2e449-af17-4cec-95bf-57f794b8f600 68084-553 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE TABLET ORAL 20120127 NDA AUTHORIZED GENERIC NDA011839 American Health Packaging MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 68084-554_fde7483c-1c37-43f0-b905-c68fcc05a6fd 68084-554 HUMAN PRESCRIPTION DRUG Methylergonovine Maleate Methylergonovine Maleate TABLET ORAL 20120501 ANDA ANDA091577 American Health Packaging METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 68084-555_b6f5819b-a668-4696-99c8-4ff13b67e062 68084-555 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20130702 ANDA ANDA075410 American Health Packaging OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68084-556_c8e26b95-96f4-4b0d-929d-31dd240cfe44 68084-556 HUMAN PRESCRIPTION DRUG Tolazamide tolazamide TABLET ORAL 20120213 ANDA ANDA070259 American Health Packaging TOLAZAMIDE 250 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68084-558_a7f953d6-3cc7-46bc-b8fb-b98c9a459b01 68084-558 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20120131 ANDA ANDA075828 American Health Packaging LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-559_a7f953d6-3cc7-46bc-b8fb-b98c9a459b01 68084-559 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20120131 ANDA ANDA075828 American Health Packaging LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-560_a7f953d6-3cc7-46bc-b8fb-b98c9a459b01 68084-560 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20120131 ANDA ANDA075828 American Health Packaging LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-561_eb16404e-48e9-4bd9-a948-7c270f57ff0f 68084-561 HUMAN PRESCRIPTION DRUG Carbamazepine ER Carbamazepine TABLET, EXTENDED RELEASE ORAL 20130624 NDA AUTHORIZED GENERIC NDA020234 American Health Packaging CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 68084-562_eb16404e-48e9-4bd9-a948-7c270f57ff0f 68084-562 HUMAN PRESCRIPTION DRUG Carbamazepine ER Carbamazepine TABLET, EXTENDED RELEASE ORAL 20130624 NDA AUTHORIZED GENERIC NDA020234 American Health Packaging CARBAMAZEPINE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 68084-563_8aa844f5-1123-466f-86d4-735a9144288b 68084-563 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110401 ANDA ANDA075350 American Health Packaging GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-564_ebefc0af-b7f4-4a84-8af3-a42b3b4f3a56 68084-564 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130705 NDA AUTHORIZED GENERIC NDA020702 American Health Packaging ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-565_ebefc0af-b7f4-4a84-8af3-a42b3b4f3a56 68084-565 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130705 NDA AUTHORIZED GENERIC NDA020702 American Health Packaging ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-567_7b35ba9d-5cf5-47d8-b8f4-4e68c80cb3a6 68084-567 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120305 ANDA ANDA091544 American Health Packaging LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 68084-568_6e71e169-bc37-4a1f-bb7d-05bb55345742 68084-568 HUMAN PRESCRIPTION DRUG ASACOL mesalamine TABLET, DELAYED RELEASE ORAL 20120123 NDA NDA019651 American Health Packaging MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 68084-571_0e5bc1a3-6e3c-4ab9-856f-fd953eacf867 68084-571 HUMAN PRESCRIPTION DRUG Isordil Titradose isosorbide dinitrate TABLET ORAL 20120213 NDA NDA012093 American Health Packaging ISOSORBIDE DINITRATE 40 mg/1 68084-577_3a0571c5-97d9-413d-a0c9-549c314913ab 68084-577 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE HYDROCHLORIDE TABLET ORAL 20120301 ANDA ANDA078701 American Health Packaging RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68084-578_b77dd52f-3506-445c-989b-916f844633f6 68084-578 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20120201 ANDA ANDA202032 American Health Packaging LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 68084-580_09853e2b-6b8c-4a03-b458-5fd988b36d7b 68084-580 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20130725 ANDA ANDA077031 American Health Packaging CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-581_0b616868-e70a-0b8b-e054-00144ff88e88 68084-581 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20130702 ANDA ANDA077560 American Health Packaging ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 68084-582_0b616868-e70a-0b8b-e054-00144ff88e88 68084-582 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20130702 20150930 ANDA ANDA077560 American Health Packaging ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 68084-583_0b616868-e70a-0b8b-e054-00144ff88e88 68084-583 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20130702 ANDA ANDA077560 American Health Packaging ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 68084-584_0b616868-e70a-0b8b-e054-00144ff88e88 68084-584 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20130702 ANDA ANDA077560 American Health Packaging ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 68084-585_3e386559-d0dc-4555-8be9-54c8dd3266cf 68084-585 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130506 ANDA ANDA085159 American Health Packaging METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68084-586_3e386559-d0dc-4555-8be9-54c8dd3266cf 68084-586 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130506 ANDA ANDA085123 American Health Packaging METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68084-587_69387493-05b8-4e9a-a478-973bfe92c8e4 68084-587 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20120702 ANDA ANDA090419 American Health Packaging MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 68084-588_69387493-05b8-4e9a-a478-973bfe92c8e4 68084-588 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET, COATED ORAL 20120702 ANDA ANDA090499 American Health Packaging MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 68084-589_ebefc0af-b7f4-4a84-8af3-a42b3b4f3a56 68084-589 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130705 NDA AUTHORIZED GENERIC NDA020702 American Health Packaging ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-590_cbb36391-3522-4ef2-a5bb-8e93a765adb8 68084-590 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130709 ANDA ANDA090548 American Health Packaging ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-591_346b8ab5-e58c-44a3-80cb-16a8c882eac8 68084-591 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130215 ANDA ANDA075155 American Health Packaging ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68084-592_346b8ab5-e58c-44a3-80cb-16a8c882eac8 68084-592 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130215 ANDA ANDA075155 American Health Packaging ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68084-593_d498024c-a0b6-4c8c-8f70-9df654d4b64a 68084-593 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20120301 ANDA ANDA074415 American Health Packaging SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 68084-594_8aa844f5-1123-466f-86d4-735a9144288b 68084-594 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20120305 ANDA ANDA075350 American Health Packaging GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-595_8aa844f5-1123-466f-86d4-735a9144288b 68084-595 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20120305 ANDA ANDA075350 American Health Packaging GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-596_2b872b24-4a06-482e-8716-93d616ccded2 68084-596 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20120301 ANDA ANDA091231 American Health Packaging PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68084-597_b11026f8-dea0-49ac-8725-0ef7dc27923f 68084-597 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120501 ANDA ANDA077127 American Health Packaging NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68084-598_b11026f8-dea0-49ac-8725-0ef7dc27923f 68084-598 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120501 ANDA ANDA077127 American Health Packaging NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68084-599_816a6c5d-fa2f-4b0c-8054-6eebfe20363b 68084-599 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20120903 ANDA ANDA077156 American Health Packaging BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 68084-600_816a6c5d-fa2f-4b0c-8054-6eebfe20363b 68084-600 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20120903 ANDA ANDA077068 American Health Packaging BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 68084-601_b0229f31-883c-42ec-ba1c-399b8d474cde 68084-601 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20120830 20161006 ANDA ANDA040656 American Health Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 68084-602_1ec7c9f1-0450-4796-9421-0b2a3b8b9734 68084-602 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20120404 ANDA ANDA040226 American Health Packaging PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68084-603_b11026f8-dea0-49ac-8725-0ef7dc27923f 68084-603 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120501 ANDA ANDA077410 American Health Packaging NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68084-604_920cfea6-2717-4827-a280-d72fc69e8312 68084-604 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20121008 ANDA ANDA076470 American Health Packaging DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 68084-605_ec81c914-34b5-4fef-88be-4bc6b1185d05 68084-605 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20130204 ANDA ANDA078619 American Health Packaging FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-606_920cfea6-2717-4827-a280-d72fc69e8312 68084-606 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20121008 ANDA ANDA076470 American Health Packaging DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 68084-607_1ec7c9f1-0450-4796-9421-0b2a3b8b9734 68084-607 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20120501 ANDA ANDA040226 American Health Packaging PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68084-608_61e51d10-eceb-48e6-b7a0-c3fa92385bf0 68084-608 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20120903 ANDA ANDA071196 American Health Packaging TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] 68084-609_488e765a-7f2d-4323-8a5c-114a46862e8f 68084-609 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120614 ANDA ANDA090540 American Health Packaging CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 68084-610_8ade9de4-67ea-42ef-b576-ee517ca2acab 68084-610 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20120831 ANDA ANDA078503 American Health Packaging OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 68084-611_ecf99864-ddea-4f29-8b0e-75d58f0a5c60 68084-611 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 20130214 ANDA ANDA071293 American Health Packaging AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 68084-612_aeb2641f-4842-43ff-a4d8-d01b4ab3f47b 68084-612 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET ORAL 20121129 ANDA ANDA079110 American Health Packaging BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 68084-613_21ec48c2-ced0-4eb3-ab4b-08a3852ff1fe 68084-613 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130620 ANDA ANDA200268 American Health Packaging PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 68084-614_21ec48c2-ced0-4eb3-ab4b-08a3852ff1fe 68084-614 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130620 ANDA ANDA200268 American Health Packaging PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 68084-615_21ec48c2-ced0-4eb3-ab4b-08a3852ff1fe 68084-615 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130620 ANDA ANDA200268 American Health Packaging PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 68084-617_eb1691ac-d8e3-4409-ae02-d7e1d9c69153 68084-617 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20130701 ANDA ANDA090432 American Health Packaging ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-618_eb1691ac-d8e3-4409-ae02-d7e1d9c69153 68084-618 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20130701 ANDA ANDA090432 American Health Packaging ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-619_472301fd-d9db-476e-bd0c-d3cdc9389b8b 68084-619 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120702 ANDA ANDA201508 American Health Packaging MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 68084-620_472301fd-d9db-476e-bd0c-d3cdc9389b8b 68084-620 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120702 ANDA ANDA201294 American Health Packaging MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 68084-621_90ece2f8-9d69-49a6-9c79-7fa628acb31f 68084-621 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20140401 ANDA ANDA202566 American Health Packaging MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 68084-622_19f9c778-3b40-4e48-ab6e-b4290514a382 68084-622 HUMAN PRESCRIPTION DRUG Sildenafil Citrate Sildenafil Citrate TABLET, FILM COATED ORAL 20121214 ANDA ANDA091379 American Health Packaging SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] 68084-623_e048083f-43ee-41d6-b4a4-27f0f8e8dddf 68084-623 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20120930 ANDA ANDA063065 American Health Packaging MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 68084-624_4cc679fd-98f0-4cd8-bac4-e52a07868c92 68084-624 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20120831 ANDA ANDA075694 American Health Packaging GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-625_4cc679fd-98f0-4cd8-bac4-e52a07868c92 68084-625 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20120831 ANDA ANDA075694 American Health Packaging GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-629_0bba1c9c-6d8b-4cb2-9682-9f3ae6d792b9 68084-629 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20130625 NDA AUTHORIZED GENERIC NDA021073 American Health Packaging PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 68084-630_0bba1c9c-6d8b-4cb2-9682-9f3ae6d792b9 68084-630 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20130625 NDA AUTHORIZED GENERIC NDA021073 American Health Packaging PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 68084-631_0bba1c9c-6d8b-4cb2-9682-9f3ae6d792b9 68084-631 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20130625 NDA AUTHORIZED GENERIC NDA021073 American Health Packaging PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 68084-632_3eebec68-25af-4d09-bd69-aee3429ddd58 68084-632 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20130118 ANDA ANDA075604 American Health Packaging POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68084-633_6605aaf0-7388-4f92-8499-2777aac23851 68084-633 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED ORAL 20121129 ANDA ANDA090216 American Health Packaging VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68084-634_6605aaf0-7388-4f92-8499-2777aac23851 68084-634 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED ORAL 20121129 20151111 ANDA ANDA090216 American Health Packaging VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68084-635_df4cb252-a5f1-41f9-ae54-02f9c8740fc8 68084-635 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20130131 ANDA ANDA090856 American Health Packaging FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68084-636_df4cb252-a5f1-41f9-ae54-02f9c8740fc8 68084-636 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20130131 ANDA ANDA090856 American Health Packaging FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68084-638_472301fd-d9db-476e-bd0c-d3cdc9389b8b 68084-638 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20130522 ANDA ANDA201508 American Health Packaging MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 68084-639_3f8d493a-df64-4419-85b0-a5809219a9de 68084-639 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20141215 ANDA ANDA077869 American Health Packaging ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-640_7ed5ecc3-181d-432f-b420-3065082becb4 68084-640 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20141013 ANDA ANDA076832 American Health Packaging LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 68084-642_5374a4cc-7b97-44aa-a41d-e8785fc06ef3 68084-642 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20140107 ANDA ANDA200265 American Health Packaging VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68084-643_a26b6ab6-e62e-4a03-954a-4def0f17bae7 68084-643 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20130826 ANDA ANDA078281 American Health Packaging PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68084-644_bba6b8f0-daf5-4b0b-bd07-4f59aa679077 68084-644 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20131016 ANDA ANDA203081 American Health Packaging IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68084-645_ef523acc-06b6-4e1c-a58b-4e5fad3407c2 68084-645 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride TABLET ORAL 20130925 ANDA ANDA076286 American Health Packaging TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68084-647_ed63f206-d8e3-4ea6-ba76-8a4bef93d982 68084-647 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20130904 ANDA ANDA074112 American Health Packaging ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-649_99930370-0a84-40a5-89ab-d87bbb062e77 68084-649 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20140122 ANDA ANDA078670 American Health Packaging PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 68084-651_fa3fd5a2-bdca-4798-9bf4-26f414be0f77 68084-651 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20140416 ANDA ANDA065136 American Health Packaging CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68084-652_99930370-0a84-40a5-89ab-d87bbb062e77 68084-652 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20140122 ANDA ANDA078670 American Health Packaging PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 68084-654_4614480b-b36e-4dbd-9fc0-d083890d297d 68084-654 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20140318 ANDA ANDA076140 American Health Packaging SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 68084-655_d276da3c-9952-4674-a54d-b1258df71b8a 68084-655 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20140113 ANDA ANDA076691 American Health Packaging LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] 68084-656_011fa7e7-e135-429e-9e42-75124132555f 68084-656 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20140217 ANDA ANDA065507 American Health Packaging AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68084-657_a26b6ab6-e62e-4a03-954a-4def0f17bae7 68084-657 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20130826 20150831 ANDA ANDA078281 American Health Packaging PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68084-658_a18c9077-8e71-4fb5-9b1c-34969e59aeb0 68084-658 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20131014 ANDA ANDA078558 American Health Packaging IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68084-659_dfe855b6-3517-4bed-92b2-b911517f4673 68084-659 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140306 ANDA ANDA090617 American Health Packaging METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-660_99930370-0a84-40a5-89ab-d87bbb062e77 68084-660 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20140122 ANDA ANDA078670 American Health Packaging PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 68084-663_011fa7e7-e135-429e-9e42-75124132555f 68084-663 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20140217 ANDA ANDA065509 American Health Packaging AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68084-665_ff6aa7af-399e-4a7d-bbc1-26ad76492cb2 68084-665 HUMAN PRESCRIPTION DRUG Verapamil Verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140114 ANDA ANDA200878 American Health Packaging VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68084-666_dfe855b6-3517-4bed-92b2-b911517f4673 68084-666 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140306 ANDA ANDA090617 American Health Packaging METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-672_ed63f206-d8e3-4ea6-ba76-8a4bef93d982 68084-672 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20130904 ANDA ANDA074112 American Health Packaging ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-673_30d85198-694a-466d-a3a9-213976f584f8 68084-673 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140512 ANDA ANDA078889 American Health Packaging METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-674_ff6aa7af-399e-4a7d-bbc1-26ad76492cb2 68084-674 HUMAN PRESCRIPTION DRUG Verapamil Verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140114 ANDA ANDA200878 American Health Packaging VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68084-675_4616f5fa-8e43-4a44-8484-f4dfd950a9b7 68084-675 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131223 ANDA ANDA090694 American Health Packaging DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-680_ff4b326d-a55d-4f9b-92d4-ed555fbf2454 68084-680 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20140922 ANDA ANDA078556 American Health Packaging DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 68084-682_ff6aa7af-399e-4a7d-bbc1-26ad76492cb2 68084-682 HUMAN PRESCRIPTION DRUG Verapamil Verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140114 ANDA ANDA200878 American Health Packaging VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68084-683_4616f5fa-8e43-4a44-8484-f4dfd950a9b7 68084-683 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131223 ANDA ANDA090694 American Health Packaging DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-692_4616f5fa-8e43-4a44-8484-f4dfd950a9b7 68084-692 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131223 ANDA ANDA090694 American Health Packaging DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-696_f3614316-c120-4d49-9306-22b42dfbc4fd 68084-696 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20140401 ANDA ANDA074501 American Health Packaging NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-698_e05bdeb4-07a9-441e-901b-f2aea550db2b 68084-698 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140203 ANDA ANDA200834 American Health Packaging VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-699_03c9ff0d-46e8-448c-944a-7ad59d1afd6d 68084-699 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20140616 ANDA ANDA202677 American Health Packaging ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 68084-703_a18c9077-8e71-4fb5-9b1c-34969e59aeb0 68084-703 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20131014 ANDA ANDA078558 American Health Packaging IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68084-707_f3614316-c120-4d49-9306-22b42dfbc4fd 68084-707 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20140401 ANDA ANDA074501 American Health Packaging NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-709_e05bdeb4-07a9-441e-901b-f2aea550db2b 68084-709 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140203 ANDA ANDA200834 American Health Packaging VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-710_03c9ff0d-46e8-448c-944a-7ad59d1afd6d 68084-710 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20140616 ANDA ANDA202677 American Health Packaging ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 68084-713_e05bdeb4-07a9-441e-901b-f2aea550db2b 68084-713 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140203 ANDA ANDA200834 American Health Packaging VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-717_3a294ce5-f6a1-46ff-a840-b20973fad9b6 68084-717 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20140707 ANDA ANDA077824 American Health Packaging RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68084-721_90ece2f8-9d69-49a6-9c79-7fa628acb31f 68084-721 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20140401 ANDA ANDA202566 American Health Packaging MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 68084-722_1ed191f5-7df5-488c-bb72-91ac0b618d9a 68084-722 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride TABLET, FILM COATED ORAL 20140320 ANDA ANDA202632 American Health Packaging MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68084-723_aa688a7c-1e13-4c36-ba0f-2e5b5978f2a4 68084-723 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140501 ANDA ANDA076255 American Health Packaging OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 68084-725_bc45263a-21bd-49e8-ad06-0d5f3dc46bfd 68084-725 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20140607 ANDA ANDA090493 American Health Packaging DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68084-726_563eff16-a16f-470c-94ca-08877e4d42f7 68084-726 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20140602 ANDA ANDA077183 American Health Packaging AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68084-727_f5882b3b-f93b-4ebf-893a-22ff17315e08 68084-727 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20140530 ANDA ANDA077912 American Health Packaging HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-728_d7aacee3-9d9c-4b36-b735-39bcb9edf941 68084-728 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140930 ANDA ANDA077731 American Health Packaging FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68084-729_6a3338b4-5ab2-4eec-8e73-599707abc710 68084-729 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20140623 ANDA ANDA090957 American Health Packaging GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68084-734_bc45263a-21bd-49e8-ad06-0d5f3dc46bfd 68084-734 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20140607 ANDA ANDA090493 American Health Packaging DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68084-735_d7aacee3-9d9c-4b36-b735-39bcb9edf941 68084-735 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140825 ANDA ANDA077731 American Health Packaging FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68084-736_1af0c69a-b2cb-4f50-af82-523871bae961 68084-736 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140401 ANDA ANDA071403 American Health Packaging LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-737_25e976c7-d3c4-4801-8ef9-5e7ebdcc8257 68084-737 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20140401 ANDA ANDA077031 American Health Packaging CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-738_f13523cc-394f-4b6c-89b3-da4e96e3cedd 68084-738 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20141002 ANDA ANDA040517 American Health Packaging METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68084-739_b72d60db-7fb8-4b57-94e8-2030f38cee6b 68084-739 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20140527 ANDA ANDA076820 American Health Packaging BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68084-740_aa688a7c-1e13-4c36-ba0f-2e5b5978f2a4 68084-740 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140501 ANDA ANDA076255 American Health Packaging OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 68084-742_1af0c69a-b2cb-4f50-af82-523871bae961 68084-742 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140401 ANDA ANDA071404 American Health Packaging LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-743_712965e2-c089-46c3-9a86-d3f61673b25d 68084-743 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20140602 ANDA ANDA065055 American Health Packaging DOXYCYCLINE 100 mg/1 68084-744_25e976c7-d3c4-4801-8ef9-5e7ebdcc8257 68084-744 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20140401 ANDA ANDA077031 American Health Packaging CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-745_fce33b2c-a12a-442d-95ed-c51bde30b3ee 68084-745 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20140530 ANDA ANDA077870 American Health Packaging GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 68084-746_581f17c6-1d7d-4bf3-9ef7-537a222d0ac1 68084-746 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20140530 ANDA ANDA077751 American Health Packaging PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68084-747_65057096-1df9-4cb8-829e-8c8bec006d60 68084-747 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20140530 ANDA ANDA076899 American Health Packaging SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 68084-748_aaa95a2a-4118-4beb-953e-c4d888c91b5f 68084-748 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine Hydrochloride TABLET ORAL 20140530 ANDA ANDA075109 American Health Packaging GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68084-749_f87902a9-31a9-4ac8-ad86-3aa63987bed8 68084-749 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20140530 ANDA ANDA078385 American Health Packaging HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68084-750_ba764ce4-36fe-4aa4-96a4-d0479b875b4f 68084-750 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20140530 ANDA ANDA071251 American Health Packaging HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68084-753_5f321a03-ccfb-4c11-ac60-a461a5580c69 68084-753 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140530 ANDA ANDA078048 American Health Packaging CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68084-754_1af0c69a-b2cb-4f50-af82-523871bae961 68084-754 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140401 ANDA ANDA071141 American Health Packaging LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-755_5ab64c23-2367-4e82-ba58-c3499d298a8a 68084-755 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20140414 ANDA ANDA074501 American Health Packaging NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-756_649185c5-f1d7-4422-8153-80823d7eefbb 68084-756 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, EXTENDED RELEASE ORAL 20141020 ANDA ANDA090860 American Health Packaging NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 68084-758_c90b0747-9493-4036-9f6b-e71fe7f38dbf 68084-758 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET ORAL 20140602 ANDA ANDA091264 American Health Packaging LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 68084-759_e8da6853-26c8-48b2-a603-5566ef697251 68084-759 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine TABLET ORAL 20140731 ANDA ANDA077533 American Health Packaging TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 68084-762_1d8bbee3-4c95-4e42-b73e-5ad68a3b8e5c 68084-762 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140701 ANDA ANDA075350 American Health Packaging GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-763_5ab64c23-2367-4e82-ba58-c3499d298a8a 68084-763 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20140414 ANDA ANDA074501 American Health Packaging NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-764_09b3fdc2-38de-4a37-ac9b-d7eabb6db0f9 68084-764 HUMAN PRESCRIPTION DRUG Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate TABLET ORAL 20140602 UNAPPROVED DRUG OTHER American Health Packaging POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 155; 852; 130 mg/1; mg/1; mg/1 68084-765_c9490e6e-c186-4a1b-9c92-dca5023e74f1 68084-765 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20140602 ANDA ANDA077321 American Health Packaging LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-766_f5882b3b-f93b-4ebf-893a-22ff17315e08 68084-766 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20140530 ANDA ANDA077912 American Health Packaging HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-772_a18c9077-8e71-4fb5-9b1c-34969e59aeb0 68084-772 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20131014 ANDA ANDA078558 American Health Packaging IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68084-773_649185c5-f1d7-4422-8153-80823d7eefbb 68084-773 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, EXTENDED RELEASE ORAL 20141020 ANDA ANDA090860 American Health Packaging NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 68084-774_1d8bbee3-4c95-4e42-b73e-5ad68a3b8e5c 68084-774 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140701 ANDA ANDA075350 American Health Packaging GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-775_ef523acc-06b6-4e1c-a58b-4e5fad3407c2 68084-775 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride TABLET ORAL 20140602 ANDA ANDA076286 American Health Packaging TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68084-776_c64f50d8-fbca-4273-9618-07ce93885f9d 68084-776 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141007 ANDA ANDA090554 American Health Packaging DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68084-777_ac5b24a4-39a8-4c8a-b293-5f59966fb444 68084-777 HUMAN OTC DRUG Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140827 ANDA ANDA076200 American Health Packaging ACETAMINOPHEN 650 mg/1 68084-779_f1ccc10a-e42d-44f7-b7da-5538f3b39461 68084-779 HUMAN PRESCRIPTION DRUG cilostazol cilostazol TABLET ORAL 20140730 ANDA ANDA077030 American Health Packaging CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 68084-782_c64f50d8-fbca-4273-9618-07ce93885f9d 68084-782 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141007 ANDA ANDA090554 American Health Packaging DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68084-783_1d8bbee3-4c95-4e42-b73e-5ad68a3b8e5c 68084-783 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140701 ANDA ANDA075350 American Health Packaging GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-784_b8fbc985-62a5-4bc2-b9b8-0451926e86de 68084-784 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20140731 ANDA ANDA075731 American Health Packaging CLORAZEPATE DIPOTASSIUM 3.75 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68084-785_85eaf9bc-9a5e-4354-9eac-c9d030bc1be4 68084-785 HUMAN PRESCRIPTION DRUG Doxycycline Monohydrate doxycycline TABLET ORAL 20141215 ANDA ANDA065070 American Health Packaging DOXYCYCLINE 100 mg/1 68084-787_9a19ffd6-2adb-4dbb-b1d0-24b9f3192084 68084-787 HUMAN OTC DRUG ORGAN-I NR guaifenesin TABLET ORAL 20140731 OTC MONOGRAPH FINAL part341 American Health Packaging GUAIFENESIN 200 mg/1 68084-788_65216872-dc40-41bf-9c2d-ce39417113b2 68084-788 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20140730 ANDA ANDA077091 American Health Packaging GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68084-789_fc29adaa-48f1-40d4-a721-307462f3025a 68084-789 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20140616 ANDA ANDA040761 American Health Packaging HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68084-790_1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e 68084-790 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 20140915 ANDA ANDA074694 American Health Packaging CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 68084-793_c6c20c9a-53ea-4584-8122-481d2962cfeb 68084-793 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20140731 ANDA ANDA078920 American Health Packaging PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68084-795_55c30f08-c42d-4d07-a66e-5c5c977e7fae 68084-795 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20141215 ANDA ANDA065379 American Health Packaging MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 68084-796_4d9a1221-8df8-4ed0-bd86-7ca6680a2803 68084-796 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140731 20161006 ANDA ANDA090415 American Health Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 68084-797_57ac19da-e60a-4fd3-a412-bb362f87bd4e 68084-797 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20141103 ANDA ANDA078926 American Health Packaging GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-798_fc7470cc-95aa-49c0-af23-ee7393f82280 68084-798 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20140814 ANDA ANDA078439 American Health Packaging HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68084-799_5067a5f6-b5ad-432f-8a8b-8504ab49a31e 68084-799 HUMAN PRESCRIPTION DRUG Balsalazide Disodium Balsalazide Disodium CAPSULE ORAL 20140731 ANDA ANDA077883 American Health Packaging BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 68084-801_085fa99c-8795-4abf-83cd-b0864f033d19 68084-801 HUMAN PRESCRIPTION DRUG Mycophenolate mofetil Mycophenolate mofetil TABLET ORAL 20141215 ANDA ANDA065451 American Health Packaging MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 68084-802_57ac19da-e60a-4fd3-a412-bb362f87bd4e 68084-802 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20140901 ANDA ANDA078926 American Health Packaging GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-803_0086c523-cf5f-45bd-8ca1-6b06df75f4c5 68084-803 HUMAN PRESCRIPTION DRUG Letrozole Letrozole TABLET, FILM COATED ORAL 20140820 ANDA ANDA091303 American Health Packaging LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 68084-804_250d1f58-83e8-42d3-a4e2-205a3a5c422e 68084-804 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20140721 NDA NDA021283 American Health Packaging VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68084-805_eb9b7377-d918-43fb-8e82-d14c85ed64a8 68084-805 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20140819 ANDA ANDA040300 American Health Packaging METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68084-807_5c9a09b5-d530-48de-97c7-a5aa59bf9b10 68084-807 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20140822 ANDA ANDA077537 American Health Packaging GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68084-808_9893b6c0-fe47-4e56-8857-d3a5a888b9fd 68084-808 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20140821 ANDA ANDA076003 American Health Packaging TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68084-810_a5983905-7b8c-4e1a-8c44-aa41eef07808 68084-810 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20140828 ANDA ANDA077633 American Health Packaging LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68084-813_a26b6ab6-e62e-4a03-954a-4def0f17bae7 68084-813 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20141216 ANDA ANDA078281 American Health Packaging PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68084-814_1c97b14f-b6a9-4f34-891c-f84280729a89 68084-814 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20140829 UNAPPROVED DRUG OTHER American Health Packaging PHENOBARBITAL 32.4 mg/1 CIV 68084-815_83e18e38-5769-4463-a292-a7ae98b3cdef 68084-815 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20140922 NDA AUTHORIZED GENERIC NDA021303 American Health Packaging AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68084-816_0d625419-5131-4a22-9e89-f7e19205525b 68084-816 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride TABLET ORAL 20140904 NDA AUTHORIZED GENERIC NDA021121 American Health Packaging METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68084-817_4a03ae56-4f2a-422a-b08e-e881dd915b15 68084-817 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20140916 ANDA ANDA091519 American Health Packaging HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68084-818_1809bcb4-5fcc-45ca-986a-4fa5edcd4b5e 68084-818 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 20140829 ANDA ANDA074694 American Health Packaging CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 68084-819_e69d2835-fb98-436d-8348-ecbe84b25d65 68084-819 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140929 ANDA ANDA090692 American Health Packaging METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68084-820_17a5fd73-9342-4ce7-8730-530b07337362 68084-820 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE ORAL 20140915 ANDA ANDA040368 American Health Packaging ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68084-822_250d1f58-83e8-42d3-a4e2-205a3a5c422e 68084-822 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20140721 NDA NDA021283 American Health Packaging VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68084-823_eb9b7377-d918-43fb-8e82-d14c85ed64a8 68084-823 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20140819 ANDA ANDA040300 American Health Packaging METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68084-825_ac453fa1-5b39-40e8-bcd1-2dd54e8ce337 68084-825 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED ORAL 20140821 ANDA ANDA077184 American Health Packaging ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68084-827_642550fb-839c-4b15-9d95-4dd9fff36ed5 68084-827 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20141020 ANDA ANDA076509 American Health Packaging FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68084-828_eb81c007-9f19-47dc-8a36-69770676fc5d 68084-828 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20140925 ANDA ANDA077290 American Health Packaging OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68084-829_0d625419-5131-4a22-9e89-f7e19205525b 68084-829 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride TABLET ORAL 20140904 NDA AUTHORIZED GENERIC NDA021121 American Health Packaging METHYLPHENIDATE HYDROCHLORIDE 36 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68084-830_1ec7c9f1-0450-4796-9421-0b2a3b8b9734 68084-830 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20140917 ANDA ANDA040226 American Health Packaging PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68084-832_83e18e38-5769-4463-a292-a7ae98b3cdef 68084-832 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20140912 NDA AUTHORIZED GENERIC NDA021303 American Health Packaging AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68084-833_0d625419-5131-4a22-9e89-f7e19205525b 68084-833 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride TABLET ORAL 20140904 NDA AUTHORIZED GENERIC NDA021121 American Health Packaging METHYLPHENIDATE HYDROCHLORIDE 54 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68084-834_4a03ae56-4f2a-422a-b08e-e881dd915b15 68084-834 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20140916 ANDA ANDA091519 American Health Packaging HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68084-835_070e1734-84c9-407e-91bc-3f8c2946b46e 68084-835 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20141001 ANDA ANDA075868 American Health Packaging FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68084-836_3f4dc1a7-05e6-41d7-908c-30ce2677d87b 68084-836 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20140922 ANDA ANDA075580 American Health Packaging DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68084-837_70c899d8-a2e7-4211-b66b-ba34102fb470 68084-837 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET ORAL 20140929 ANDA ANDA075902 American Health Packaging FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68084-838_e091b8e7-f467-4715-a248-8ca7a26f9731 68084-838 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, COATED ORAL 20140922 ANDA ANDA074903 American Health Packaging ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68084-839_8bab5f89-2c8c-47f9-a479-bb009940a0e1 68084-839 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 20140929 ANDA ANDA040101 American Health Packaging PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68084-841_fcd31ebe-f2b9-46d9-8701-79bd158870f6 68084-841 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20141006 ANDA ANDA076642 American Health Packaging HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII 68084-842_1ec7c9f1-0450-4796-9421-0b2a3b8b9734 68084-842 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20141009 ANDA ANDA040226 American Health Packaging PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68084-843_48104cef-bb7e-4eac-a916-9aa986ffaf66 68084-843 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20141215 ANDA ANDA077614 American Health Packaging CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68084-845_1664b832-7fed-451c-9783-4ad8f8fc354d 68084-845 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20141113 ANDA ANDA078069 American Health Packaging OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-846_653b9cc3-dd87-427e-80f5-1c73bc764393 68084-846 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20141013 ANDA ANDA089742 American Health Packaging FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68084-848_80cb146e-d98b-43e5-8364-ef1e221f7afc 68084-848 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength TABLET ORAL 20140918 OTC MONOGRAPH FINAL part343 American Health Packaging ASPIRIN 325 mg/1 68084-850_1201c777-2388-4235-bb8f-eb7dc1e867f8 68084-850 HUMAN PRESCRIPTION DRUG Potassium Citrate Potassium Citrate TABLET, EXTENDED RELEASE ORAL 20141001 ANDA ANDA203546 American Health Packaging POTASSIUM CITRATE 10 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 68084-851_3f4dc1a7-05e6-41d7-908c-30ce2677d87b 68084-851 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20140922 ANDA ANDA075580 American Health Packaging DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68084-852_6cdd1d05-3706-40e2-982c-1f92c3f6c626 68084-852 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141006 ANDA ANDA090415 American Health Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 300; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 68084-853_1664b832-7fed-451c-9783-4ad8f8fc354d 68084-853 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20141113 ANDA ANDA078069 American Health Packaging OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-854_48104cef-bb7e-4eac-a916-9aa986ffaf66 68084-854 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20141215 ANDA ANDA077614 American Health Packaging CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68084-858_844b64f9-6dae-4076-bda2-fa8cfa730083 68084-858 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141020 ANDA ANDA078540 American Health Packaging PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] 68084-859_fc8bf57e-8aa2-4d3c-856d-b19de65e3ba0 68084-859 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20141215 ANDA ANDA078993 American Health Packaging LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-860_eb9b7377-d918-43fb-8e82-d14c85ed64a8 68084-860 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20140819 ANDA ANDA040300 American Health Packaging METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68084-862_3f4dc1a7-05e6-41d7-908c-30ce2677d87b 68084-862 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20140922 ANDA ANDA075580 American Health Packaging DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68084-863_6c119874-2a82-421b-9f65-5de5776baadc 68084-863 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20141006 ANDA ANDA040656 American Health Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 68084-865_48104cef-bb7e-4eac-a916-9aa986ffaf66 68084-865 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20141215 ANDA ANDA077614 American Health Packaging CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68084-866_5cc17a75-7ea9-4129-a1ee-ba3dcd64df76 68084-866 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Extended-Release Clonidine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141027 ANDA ANDA202984 American Health Packaging CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68084-867_1664b832-7fed-451c-9783-4ad8f8fc354d 68084-867 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20141113 ANDA ANDA078069 American Health Packaging OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-870_fc8bf57e-8aa2-4d3c-856d-b19de65e3ba0 68084-870 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20141215 ANDA ANDA078993 American Health Packaging LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-871_332c627d-f1eb-4f38-9153-d78e0f527e08 68084-871 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET ORAL 20141113 ANDA ANDA090842 American Health Packaging RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 68084-872_3a0919fa-3ff5-43d9-bf37-2da671c34bf2 68084-872 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol CAPSULE ORAL 20141215 ANDA ANDA091433 American Health Packaging DOXERCALCIFEROL .5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] 68084-874_fdeb76f5-e6af-4f8b-b901-731d65a70b18 68084-874 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20141204 ANDA ANDA040439 American Health Packaging AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68084-876_48104cef-bb7e-4eac-a916-9aa986ffaf66 68084-876 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20141215 ANDA ANDA077614 American Health Packaging CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68084-877_735defb6-f30f-48b8-8648-379944bf4bbd 68084-877 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20141215 ANDA ANDA078702 American Health Packaging CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68084-879_a8e29b54-e4ab-4bb9-ab6c-e4414a3f025b 68084-879 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED ORAL 20141215 ANDA ANDA065040 American Health Packaging CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68084-880_83e18e38-5769-4463-a292-a7ae98b3cdef 68084-880 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20141215 NDA AUTHORIZED GENERIC NDA021303 American Health Packaging AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68084-882_fc8bf57e-8aa2-4d3c-856d-b19de65e3ba0 68084-882 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20141215 ANDA ANDA078993 American Health Packaging LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-883_5fb93832-0cab-4c23-a1b0-c40157904ff4 68084-883 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20141215 ANDA ANDA200815 American Health Packaging FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68084-884_fc3c3d40-69ba-4273-b7a1-cf715b68478d 68084-884 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141006 ANDA ANDA040148 American Health Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 68084-886_97ae71b3-6dc1-426d-a5d8-042710d1224f 68084-886 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20141215 ANDA ANDA076449 American Health Packaging MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 68084-887_83e18e38-5769-4463-a292-a7ae98b3cdef 68084-887 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20140915 NDA AUTHORIZED GENERIC NDA021303 American Health Packaging AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68084-888_3286c4e0-8d18-4559-90b0-8fff07f41a2d 68084-888 HUMAN PRESCRIPTION DRUG TROSPIUM CHLORIDE TROSPIUM CHLORIDE TABLET ORAL 20141215 ANDA ANDA091513 American Health Packaging TROSPIUM CHLORIDE 20 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 68084-889_6e495257-2c4a-484a-999a-5dae4dbe2a19 68084-889 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141215 ANDA ANDA078179 American Health Packaging ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 68084-892_e7e3e43e-02dc-4fec-b3bb-608856960838 68084-892 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET, FILM COATED ORAL 20141215 ANDA ANDA200826 American Health Packaging URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 68084-893_fc8bf57e-8aa2-4d3c-856d-b19de65e3ba0 68084-893 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20141215 ANDA ANDA078993 American Health Packaging LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68084-894_7aa162e7-1dc7-4881-8d1b-1a76e11434a8 68084-894 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20141215 ANDA ANDA086221 American Health Packaging ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68084-895_673c132c-fc85-4ddd-b50b-45f93f01fd90 68084-895 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141006 ANDA ANDA040736 American Health Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 68084-897_5ab64c23-2367-4e82-ba58-c3499d298a8a 68084-897 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20141215 ANDA ANDA074501 American Health Packaging NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68084-898_83e18e38-5769-4463-a292-a7ae98b3cdef 68084-898 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20141215 NDA AUTHORIZED GENERIC NDA021303 American Health Packaging AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68084-902_a4ebf74d-4218-44cd-99dc-497aedd93291 68084-902 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141201 ANDA ANDA078458 American Health Packaging METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68084-903_58e0757b-d751-4b31-8bb5-f23678e0a9c4 68084-903 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20141215 ANDA ANDA075994 American Health Packaging LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68084-909_83e18e38-5769-4463-a292-a7ae98b3cdef 68084-909 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20141215 NDA AUTHORIZED GENERIC NDA021303 American Health Packaging AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68085-8012_6bf15075-53a3-468f-be62-b90e56310ff9 68085-8012 HUMAN OTC DRUG Piyanping antiitch Hydrocortisone CREAM TOPICAL 20110416 OTC MONOGRAPH NOT FINAL part348 Guangdong Zhanjiang Jimin Pharmaceutical Company, Ltd. HYDROCORTISONE 1 g/100g 68088-515_4de99e8e-1847-4283-85fa-d87a908f9963 68088-515 HUMAN OTC DRUG LANDRUM INSTANT HAND SANITIZER ethanol GEL TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Kentucky Technology LLC. ETHANOL 600 mL/1000mL 68089-004_7d9a6eba-157f-4113-ae68-e96c4a86ac37 68089-004 HUMAN OTC DRUG Clear Sinus and Ear Pulsatilla Vulgaris, Euphorbia Resinifera Resin, Calcium Sulfate and Oyster Shell Calcium Carbonate, Crude CAPSULE ORAL 20080801 UNAPPROVED HOMEOPATHIC Clear Products, Inc. CALCIUM SULFATE; EUPHORBIA RESINIFERA RESIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS 3; 6; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 68093-7038_8d3ba79a-399a-4e6f-9a74-f895edc41ccd 68093-7038 HUMAN OTC DRUG StingEze Insect Bite Relief Benzocaine, Phenol, Camphor LIQUID TOPICAL 20090201 OTC MONOGRAPH NOT FINAL part348 Wisconsin Pharmacal Company BENZOCAINE; CAMPHOR (SYNTHETIC); PHENOL .05; .03; .0135 g/g; g/g; g/g 68093-7079_7e0c7c7b-6625-46cd-abd6-630d9c78f122 68093-7079 HUMAN OTC DRUG VH Essentials Sensitive Medicated Cream Benzocaine, Benzalkonium Chloride CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part348 Wisconsin Pharmacal Company BENZALKONIUM CHLORIDE; BENZOCAINE .0013; .05 g/g; g/g 68093-7091_86ba82da-448d-4b04-8b85-048bd5d3d9e2 68093-7091 HUMAN OTC DRUG ColemanHand Sanitizer Hand Sanitizer Ethyl Alcohol SPRAY TOPICAL 20090501 OTC MONOGRAPH NOT FINAL part333A Wisconsin Pharmacal Company ALCOHOL .62 g/g 68093-7120_89c233f2-863e-4e96-9ad7-a24336422d87 68093-7120 HUMAN OTC DRUG CVS Sore Muscle Rub Vanishing Scent Menthol CREAM TOPICAL 20080601 OTC MONOGRAPH FINAL part341 Wisconsin Pharmacal Company MENTHOL .025 g/g 68093-7151_8354a619-f4ca-4a16-b040-352c7e47c0ed 68093-7151 HUMAN OTC DRUG StingEze Max Insect Bite Relief Benzocaine, Camphor, Phenol LIQUID TOPICAL 20090201 OTC MONOGRAPH NOT FINAL part348 Wisconsin Pharmacal Company BENZOCAINE; CAMPHOR (SYNTHETIC); PHENOL .1; .03; .0135 g/g; g/g; g/g 68093-7207_0ae8ba89-7926-4b3d-8bdc-dee10f9e3092 68093-7207 HUMAN OTC DRUG MG217 Psoriasis Psoriasis Treatment Intensive Strength Coal Tar OINTMENT TOPICAL 20120601 OTC MONOGRAPH FINAL part358H Wisconsin Pharmacal Company COAL TAR .02 g/g 68093-7208_2c2c395a-0b59-47b8-b973-eed29f2fedbc 68093-7208 HUMAN OTC DRUG MG217 Psoriasis Medicated Conditioning Coal Tar SHAMPOO TOPICAL 20120701 OTC MONOGRAPH FINAL part358H Wisconsin Pharmacal Company COAL TAR .03 g/g 68094-106_59d498ed-5b53-4bda-9e67-e609d0179b0e 68094-106 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride SOLUTION ORAL 20090901 ANDA ANDA073243 Precision Dose Inc. LOPERAMIDE HYDROCHLORIDE 1 mg/5mL 68094-107_5f2e67a7-d105-4208-ad3c-443741367d78 68094-107 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride SUSPENSION ORAL 20140226 ANDA ANDA091292 Precision Dose Inc. LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 68094-108_bc556980-4841-4a2f-a83a-50bdbfb7826f 68094-108 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride SUSPENSION ORAL 20140226 ANDA ANDA091292 Precision Dose Inc. LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 68094-171_40d9120f-c1c1-4b9c-82bd-9227c1c375cc 68094-171 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate SUSPENSION ORAL 20030821 NDA NDA019183 Precision Dose Inc. SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 68094-193_a7098733-ceb2-4bde-baf6-e311194cc3d0 68094-193 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid SOLUTION ORAL 20031210 ANDA ANDA070868 Precision Dose Inc. VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68094-204_6a998559-d8ad-498e-9c14-24f3eca58426 68094-204 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride SOLUTION ORAL 20030821 ANDA ANDA078312 Precision Dose Inc. RANITIDINE HYDROCHLORIDE 150 mg/10mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68094-205_6a998559-d8ad-498e-9c14-24f3eca58426 68094-205 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride SOLUTION ORAL 20061013 ANDA ANDA078312 Precision Dose Inc. RANITIDINE HYDROCHLORIDE 75 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68094-214_00141076-6810-4cd2-b72b-25e6b2f1a2c7 68094-214 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine SUSPENSION ORAL 20030902 ANDA ANDA076729 Precision Dose Inc. CARBAMAZEPINE 200 mg/10mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 68094-217_59d498ed-5b53-4bda-9e67-e609d0179b0e 68094-217 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride SOLUTION ORAL 20090818 ANDA ANDA073243 Precision Dose Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/10mL 68094-250_d40da759-a31d-476e-9199-5d8706208f72 68094-250 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20140623 ANDA ANDA075671 Precision Dose Inc. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 68094-301_00141076-6810-4cd2-b72b-25e6b2f1a2c7 68094-301 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine SUSPENSION ORAL 20070227 ANDA ANDA076729 Precision Dose Inc. CARBAMAZEPINE 100 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 68094-316_6a998559-d8ad-498e-9c14-24f3eca58426 68094-316 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride SOLUTION ORAL 20110425 ANDA ANDA078312 Precision Dose Inc. RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68094-325_bd4b1dfc-f1f9-401f-994e-5684543b0823 68094-325 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride SOLUTION ORAL 20100511 ANDA ANDA077009 Precision Dose Inc. ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68094-361_b729b5b9-bc41-49c9-b6c7-8fced6dd506f 68094-361 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20141008 ANDA ANDA075671 Precision Dose Inc. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 68094-494_1f0d9154-f8e1-47c5-9143-cbba8f7b74ea 68094-494 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20040413 ANDA ANDA074937 Precision Dose Inc. IBUPROFEN 100 mg/5mL 68094-503_1f0d9154-f8e1-47c5-9143-cbba8f7b74ea 68094-503 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060914 ANDA ANDA074937 Precision Dose Inc. IBUPROFEN 200 mg/10mL 68094-518_6ea13580-eb21-41df-9e27-2d9b7902ce4c 68094-518 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20070109 ANDA ANDA075671 Precision Dose Inc. MEGESTROL ACETATE 800 mg/20mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 68094-528_6ea13580-eb21-41df-9e27-2d9b7902ce4c 68094-528 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20040225 ANDA ANDA075671 Precision Dose Inc. MEGESTROL ACETATE 400 mg/10mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 68094-533_15a01f4c-4575-446c-adc8-fe63dcb48625 68094-533 HUMAN PRESCRIPTION DRUG Phenytoin phenytoin SUSPENSION ORAL 20040205 ANDA ANDA040420 Precision Dose Inc. PHENYTOIN 100 mg/4mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68094-586_535e7e54-2303-4358-8236-9246495e2ca1 68094-586 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20140730 OTC MONOGRAPH NOT FINAL part343 Precision Dose Inc. ACETAMINOPHEN 160 mg/5mL 68094-587_e29450a1-9ccd-40c0-aed8-f233b6b5a48c 68094-587 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20140411 OTC MONOGRAPH NOT FINAL part343 Precision Dose Inc. ACETAMINOPHEN 160 mg/5mL 68094-588_b140f0ad-13e3-4f96-b1ef-f4568e1f6edc 68094-588 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20140423 OTC MONOGRAPH NOT FINAL part343 Precision Dose Inc. ACETAMINOPHEN 160 mg/5mL 68094-593_28272ed4-4046-49bc-a28d-49e4054da548 68094-593 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20051025 OTC MONOGRAPH FINAL part343 Precision Dose Inc. ACETAMINOPHEN 160 mg/5mL 68094-599_7105726a-aee9-412a-bcb0-d07ead89e896 68094-599 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20051215 ANDA ANDA062512 Precision Dose, Inc. NYSTATIN 500000 [USP'U]/5mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 68094-614_28272ed4-4046-49bc-a28d-49e4054da548 68094-614 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20080321 OTC MONOGRAPH FINAL part343 Precision Dose Inc. ACETAMINOPHEN 325 mg/10.15mL 68094-650_28272ed4-4046-49bc-a28d-49e4054da548 68094-650 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20080321 OTC MONOGRAPH FINAL part343 Precision Dose Inc. ACETAMINOPHEN 650 mg/20.3mL 68094-676_5ae950c6-668c-47c6-b1ce-aee8f4248b80 68094-676 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride SOLUTION ORAL 20071126 ANDA ANDA074703 Precision Dose Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/10mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 68094-701_a7098733-ceb2-4bde-baf6-e311194cc3d0 68094-701 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid SOLUTION ORAL 20070130 ANDA ANDA070868 Precision Dose Inc. VALPROIC ACID 500 mg/10mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68094-714_6b680ebb-2ded-4d6e-be0f-87e431e99c55 68094-714 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen SOLUTION ORAL 20140227 ANDA ANDA040894 Precision Dose Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII 68094-716_c5e28ed8-c42f-4e80-b2c0-a25ebbf19d85 68094-716 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride SYRUP ORAL 20101011 ANDA ANDA076379 Precision Dose Inc. MIDAZOLAM HYDROCHLORIDE 10 mg/5mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68094-720_a7ade6c3-d53e-4904-81fe-a3b2b3ee9755 68094-720 HUMAN OTC DRUG Childrens Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20090317 ANDA ANDA090254 Precision Dose Inc. CETIRIZINE HYDROCHLORIDE 5 mg/5mL 68094-750_ed2bb1ac-4699-4edb-a344-c9cf1f71c49d 68094-750 HUMAN PRESCRIPTION DRUG Diazepam Diazepam SOLUTION ORAL 20120222 ANDA ANDA070928 Precision Dose Inc. DIAZEPAM 5 mg/5mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68094-752_b4a43784-d0fc-4998-8304-7ddb14dad2ad 68094-752 HUMAN PRESCRIPTION DRUG Digoxin Digoxin SOLUTION ORAL 20120504 NDA NDA021648 Precision Dose Inc. DIGOXIN .05 mg/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 68094-756_039b4fe9-be5c-4588-86a8-06422ba61923 68094-756 HUMAN PRESCRIPTION DRUG Furosemide Furosemide SOLUTION ORAL 20121023 ANDA ANDA070434 Precision Dose Inc. FUROSEMIDE 40 mg/4mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 68094-757_0be4ca00-945d-4c9a-abbe-7e844df508c1 68094-757 HUMAN PRESCRIPTION DRUG Lithium Lithium carbonate SOLUTION ORAL 20121025 NDA NDA018421 Precision Dose Inc. LITHIUM CARBONATE 300 mg/5mL Mood Stabilizer [EPC] 68094-760_88ae4dcd-8d30-48a4-8881-5509d2b6975c 68094-760 HUMAN PRESCRIPTION DRUG Codeine Sulfate Codeine Sulfate SOLUTION ORAL 20130225 NDA NDA202245 Precision Dose Inc. CODEINE SULFATE 15 mg/2.5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68094-761_f7475654-2f0e-4849-ab22-60aa08f4220d 68094-761 HUMAN PRESCRIPTION DRUG Codeine Sulfate Codeine Sulfate SOLUTION ORAL 20130226 NDA NDA202245 Precision Dose Inc. CODEINE SULFATE 30 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68094-852_a0ee27db-3bc9-433e-81d7-24322d5f70ec 68094-852 HUMAN PRESCRIPTION DRUG Hyrdomorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20140217 ANDA ANDA076723 Precision Dose Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68094-853_15d827e4-bb81-4a24-adea-bde29b0d32a1 68094-853 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride naltrexone Hydrochloride TABLET, FILM COATED ORAL 20141029 ANDA ANDA075274 Precision Dose Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] 68099-304_0d1dea88-ec0e-488f-af4c-9ead25b6e8a6 68099-304 HUMAN OTC DRUG Chrono Repair Solaire Octinoxate, Octocrylene, Oxybenzone, Titanium Dioxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Laboratoire Sintyl SA OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 5; 5; 3 mg/100mg; mg/100mg; mg/100mg; mg/100mg 68105-003_45b81918-52ed-4202-b43f-7521d0d46f84 68105-003 HUMAN OTC DRUG Jurlique Moisturizing Hand Sanitizer Natural Antibacterial ALCOHOL LOTION TOPICAL 20110117 OTC MONOGRAPH NOT FINAL part333E Jurlique International Pty. Ltd. ALCOHOL 613.8 mg/mL 68105-004_1027a948-e345-4f76-9c3c-91256e8d9d30 68105-004 HUMAN OTC DRUG Jurlique Purely Sun-Defying Moisturizer with SPF 15 Sunscreen ZINC OXIDE and TITANIUM DIOXIDE CREAM, AUGMENTED TOPICAL 20111101 OTC MONOGRAPH FINAL part352 Jurlique International Pty. Ltd. TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.8 g/100g; g/100g 68105-005_4b7fb903-ee50-4b07-81c6-e0023b652941 68105-005 HUMAN OTC DRUG Jurlique Sun Sunscreen SPF 30 Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide CREAM, AUGMENTED TOPICAL 20130101 OTC MONOGRAPH FINAL part352 Jurlique International Pty. Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 50; 21 mg/mL; mg/mL; mg/mL; mg/mL 68113-107_a93cb1c1-283c-45f4-bfa8-c67c62106b73 68113-107 HUMAN OTC DRUG POVIDONE-IODINE Prep Pad POVIDONE-IODINE SWAB TOPICAL 20130211 OTC MONOGRAPH NOT FINAL part333A Carribbean Medical Brokers d.b.a. Specialty Medical Supplies POVIDONE-IODINE .1 g/1 68113-114_5b2eb257-a084-46fc-84db-b58a9a337723 68113-114 HUMAN OTC DRUG Sterile Alcohol Prep Pads Isopropyl Alcohol LIQUID TOPICAL 20120712 OTC MONOGRAPH NOT FINAL part333A Carribbean Medical Brokers d.b.a. Specialty Medical Supplies ISOPROPYL ALCOHOL .8 g/mL 68113-520_e2785abe-ca1f-4044-9d7b-68ee4ae40f6e 68113-520 HUMAN OTC DRUG Alcohol Prep ISOPROPYL ALCOHOL SWAB TOPICAL 20130418 OTC MONOGRAPH NOT FINAL part333A CARIBBEAN MEDICAL BROKERS, INC ISOPROPYL ALCOHOL 70 1/1 68113-720_76b5e3c5-c014-47e7-b895-fa37f15ea5ee 68113-720 HUMAN OTC DRUG Sterile Alcohol Prep Pad Sterile Alcohol Prep Pad LIQUID TOPICAL 20110224 OTC MONOGRAPH NOT FINAL part333E Caribbean Medical Brokers ALCOHOL .8 g/mL 68113-996_5d7947ab-f60d-499d-84dd-bddd949caf78 68113-996 HUMAN OTC DRUG Alcohol Prep Pad Alcohol Prep Pad LIQUID TOPICAL 20050101 OTC MONOGRAPH NOT FINAL part333E Caribbean Medical Brokers ISOPROPYL ALCOHOL 70 mL/100mL 68121-174_b0594ee0-a10c-4fb0-99f1-d4c26d0d5c6f 68121-174 HUMAN OTC DRUG Morning Fresh Sodium Fluoride PASTE ORAL 20140514 OTC MONOGRAPH FINAL part355 Patcos Cosmetics (India) Private Limited SODIUM FLUORIDE 2.2 mg/g 68134-363_f12a82bb-da8c-4ee0-a3e7-530b11fa4d98 68134-363 HUMAN PRESCRIPTION DRUG Naproxen Naproxen SUSPENSION ORAL 20130625 ANDA ANDA074190 Palmetto Pharmaceuticals NAPROXEN 125 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68135-020_25f27c86-d593-43c6-a030-a104b38f0856 68135-020 HUMAN PRESCRIPTION DRUG NAGLAZYME galsulfase SOLUTION INTRAVENOUS 20050609 BLA BLA125117 BioMarin Pharmaceutical Inc. GALSULFASE 5 mg/5mL alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC] 68135-100_c974794f-a3bc-4c27-b42f-663ecf67389e 68135-100 HUMAN PRESCRIPTION DRUG VIMIZIM elosulfase alfa INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140214 BLA BLA125460 BioMarin Pharmaceutical Inc. ELOSULFASE ALFA 5 mg/5mL alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC] 68135-300_61216a56-21ad-478d-a02d-ac28135b1af9 68135-300 HUMAN PRESCRIPTION DRUG Kuvan SAPROPTERIN DIHYDROCHLORIDE TABLET ORAL 20071214 NDA NDA022181 BioMarin Pharmaceutical Inc. SAPROPTERIN DIHYDROCHLORIDE 100 mg/1 Phenylalanine Hydroxylase Activator [EPC],Phenylalanine Hydroxylase Activators [MoA] 68135-301_61216a56-21ad-478d-a02d-ac28135b1af9 68135-301 HUMAN PRESCRIPTION DRUG Kuvan SAPROPTERIN DIHYDROCHLORIDE POWDER, FOR SOLUTION ORAL 20140221 NDA NDA205065 BioMarin Pharmaceutical Inc. SAPROPTERIN DIHYDROCHLORIDE 100 mg/1 Phenylalanine Hydroxylase Activator [EPC],Phenylalanine Hydroxylase Activators [MoA] 68151-0012_7e5037b1-4d47-4454-8cde-b93717dbcb54 68151-0012 HUMAN OTC DRUG Calcium carbonate Calcium carbonate TABLET ORAL 19990412 OTC MONOGRAPH FINAL part331 Carilion Materials Management CALCIUM CARBONATE 648 mg/1 68151-0017_877cfc62-beb1-43fc-b9fe-ffee0645b6f4 68151-0017 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20020709 ANDA ANDA075616 Carilion Materials Management NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68151-0079_666f12fd-f985-48de-8689-84b8eb95a484 68151-0079 HUMAN PRESCRIPTION DRUG Ticlopidine Hydrochloride Ticlopidine Hydrochloride TABLET, FILM COATED ORAL 19990907 ANDA ANDA075149 Carilion Materials Management TICLOPIDINE HYDROCHLORIDE 250 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 68151-0084_63172c12-aa33-40d2-a08f-c88aa73c6bd9 68151-0084 HUMAN PRESCRIPTION DRUG Flucytosine Flucytosine CAPSULE ORAL 20110715 ANDA ANDA201566 Carilion Materials Management FLUCYTOSINE 250 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] 68151-0088_449f81b8-8255-4348-834e-d37d12f2835e 68151-0088 HUMAN PRESCRIPTION DRUG CALCITRIOL CALCITRIOL CAPSULE ORAL 20090826 NDA AUTHORIZED GENERIC NDA018044 Carilion Materials Management CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 68151-0089_3c9bbefa-bc19-4e72-a6a0-5b0e711ae449 68151-0089 HUMAN PRESCRIPTION DRUG Cardene SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19920221 NDA NDA020005 Carilion Materials Management NICARDIPINE HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68151-0092_53a5bc28-b84f-47aa-a394-574b280fcc72 68151-0092 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride nicardipine hydrochloride CAPSULE ORAL 19960719 ANDA ANDA074642 Carilion Materials Management NICARDIPINE HYDROCHLORIDE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68151-0093_591a435d-3eeb-4dae-bfb4-f8001077fcb4 68151-0093 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride nicardipine hydrochloride CAPSULE ORAL 19960719 ANDA ANDA074642 Carilion Materials Management NICARDIPINE HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68151-0098_57b24663-e4b4-4314-ad46-3bef15727fa8 68151-0098 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 19980617 ANDA ANDA074754 Carilion Materials Management KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68151-0149_ef58e1bd-f9f8-4474-853c-fe46a5ff26b4 68151-0149 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET ORAL 20090704 ANDA ANDA078939 Carilion Materials Management ETHAMBUTOL HYDROCHLORIDE 100 mg/1 Antimycobacterial [EPC] 68151-0155_04cdc6b9-06c5-44ff-84f4-9d7799e047c6 68151-0155 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET ORAL 20100401 ANDA ANDA065425 Carilion Materials Management DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] 68151-0158_c4a9ae69-cdd0-4847-a64e-f7f367f6e3db 68151-0158 HUMAN PRESCRIPTION DRUG Mephyton phytonadione TABLET ORAL 20130319 NDA NDA010104 Carilion Materials Management PHYTONADIONE 5 mg/1 Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 68151-0162_360aba5b-d3e9-4ec0-8eaa-b391651f45c5 68151-0162 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride Amiloride Hydrochloride TABLET ORAL 19860122 ANDA ANDA070346 Carilion Materials Management AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 68151-0177_f825c7cf-8c71-4559-bee6-dcf08c56fb9b 68151-0177 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 Carilion Materials Management SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68151-0182_4655ea9f-2e76-4637-a1b6-18f38232c642 68151-0182 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Carilion Materials Management LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68151-0183_09269f7f-91b7-4bef-9b47-1094b60b7859 68151-0183 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Carilion Materials Management LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68151-0184_d23bd333-a1d5-428b-9b3f-9cb545dac44c 68151-0184 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075718 Carilion Materials Management FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68151-0185_faab6646-d9d0-4835-9b83-d55e34a2520d 68151-0185 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 Carilion Materials Management FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68151-0237_efcddc0e-454b-45e3-b78c-1e9f5a2cdb8a 68151-0237 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 Carilion Materials Management LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 68151-0238_16085835-5a05-4514-8b4d-ee1ec49833a0 68151-0238 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 Carilion Materials Management LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] 68151-0245_972970a5-df24-457b-b22d-fe3c6a86bef1 68151-0245 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20040105 ANDA ANDA076691 Carilion Materials Management LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] 68151-0308_41a09fde-0135-4110-b3f4-90fc3ef8f58d 68151-0308 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20060804 ANDA ANDA076690 Carilion Materials Management VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68151-0314_0865cadb-5b1e-455e-ae44-e67844b8011b 68151-0314 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET ORAL 19930630 NDA AUTHORIZED GENERIC NDA020215 Carilion Materials Management ISOSORBIDE MONONITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68151-0329_c0ef9358-fc50-4d00-9d93-f21361ed1d05 68151-0329 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Carilion Materials Management PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68151-0487_63079f04-872d-412d-b030-244594867225 68151-0487 HUMAN PRESCRIPTION DRUG Chloroquine Chloroquine Phosphate TABLET, COATED ORAL 19990917 ANDA ANDA083082 Carilion Materials Management CHLOROQUINE PHOSPHATE 500 mg/1 Antimalarial [EPC] 68151-0490_a6756f3a-7ee3-444e-adcd-e7ab11e91852 68151-0490 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20100723 ANDA ANDA091004 Carilion Materials Management ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] 68151-0511_8248c857-15e9-4504-a417-38196b6e399d 68151-0511 HUMAN PRESCRIPTION DRUG Plaquenil Hydroxychloroquine Sulfate TABLET ORAL 20130628 NDA NDA009768 Carilion Materials Management HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 68151-0523_3008eb03-1cf6-4dbd-b749-cb99021e0290 68151-0523 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET ORAL 20010131 ANDA ANDA075845 Carilion Materials Management OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68151-0526_eee23048-2a09-4791-b57c-f61b8458ec92 68151-0526 HUMAN PRESCRIPTION DRUG Norpace disopyramide phosphate CAPSULE, GELATIN COATED ORAL 19820720 NDA NDA018655 Carilion Materials Management DISOPYRAMIDE PHOSPHATE 100 mg/1 Antiarrhythmic [EPC] 68151-0527_ab01df3a-64fa-41c8-a5f3-e71003d5b298 68151-0527 HUMAN PRESCRIPTION DRUG Norpace disopyramide phosphate CAPSULE, GELATIN COATED ORAL 19820720 NDA NDA018655 Carilion Materials Management DISOPYRAMIDE PHOSPHATE 150 mg/1 Antiarrhythmic [EPC] 68151-0528_557136f9-cbff-4605-a037-d81fd1aee66e 68151-0528 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 19900930 ANDA ANDA070102 Carilion Materials Management DISOPYRAMIDE PHOSPHATE 150 mg/1 Antiarrhythmic [EPC] 68151-0561_dcd2cd6f-3c05-443e-8920-78f3af8bd887 68151-0561 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19980811 ANDA ANDA075219 Carilion Materials Management DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68151-0574_67134cc2-d227-498b-bfc4-4bdecb13660e 68151-0574 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20110613 ANDA ANDA091083 Carilion Materials Management NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68151-0607_edc24a6c-4754-4695-af73-de2797457ba7 68151-0607 HUMAN PRESCRIPTION DRUG Donnatal PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE TABLET ORAL 20080507 UNAPPROVED DRUG OTHER Carilion Materials Management ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 68151-0609_209a55b3-7e5f-4729-8b66-015b79d3e5e7 68151-0609 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20080825 ANDA ANDA077419 Carilion Materials Management POTASSIUM CHLORIDE 8 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68151-0614_eb9cc48b-4d89-4a5e-a15f-392f13ac3dd2 68151-0614 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20080714 ANDA ANDA040847 Carilion Materials Management GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 68151-0623_b7c33183-d88e-4226-a16c-a0caa07e37d2 68151-0623 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 19951017 ANDA ANDA074145 Carilion Materials Management GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68151-0639_84e084f6-2c6c-47f6-ad6e-8b53781b2afb 68151-0639 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20041028 ANDA ANDA076832 Carilion Materials Management LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 68151-0648_155578ed-dc71-4e4a-9bbc-24776611b706 68151-0648 HUMAN OTC DRUG Senna Sennosides A and B SYRUP ORAL 20120423 OTC MONOGRAPH NOT FINAL part334 Carilion Materials Management SENNOSIDES A AND B 8.8 mg/5mL 68151-0667_be465ab6-b69f-4796-88d8-5deec234d20f 68151-0667 HUMAN PRESCRIPTION DRUG Theophylline Anhydrous Theophylline TABLET, EXTENDED RELEASE ORAL 20120202 ANDA ANDA087571 Carilion Materials Management THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 68151-0681_8135b1f1-f53f-4d0a-8e1c-217044a1f7f1 68151-0681 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 Carilion Materials Management RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68151-0692_ab891965-e4cc-4653-870f-100c2587181e 68151-0692 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19930629 ANDA ANDA072924 Carilion Materials Management VERAPAMIL HYDROCHLORIDE 40 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68151-0703_18a426c3-9e67-4e26-8bf8-49681524c9dd 68151-0703 HUMAN OTC DRUG Acetaminophen and Diphenhydramine HCl Acetaminophen and Diphenhydramine HCl TABLET ORAL 20101006 OTC MONOGRAPH NOT FINAL part343 Carilion Materials Management ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 68151-0738_df2e3dde-cbfb-45c6-aa59-7cda327e0d1b 68151-0738 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20010209 ANDA ANDA075665 Carilion Materials Management ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68151-0757_69d44f92-7e88-4792-9e36-c658681cbbdf 68151-0757 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070611 ANDA ANDA077522 Carilion Materials Management TRANDOLAPRIL 1 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68151-0765_6b01ad0e-72e9-423e-a542-26073a779a80 68151-0765 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031107 ANDA ANDA076467 Carilion Materials Management GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68151-0848_7cb7e276-95ce-4cd8-aeb4-92fd4aa7dd68 68151-0848 HUMAN PRESCRIPTION DRUG Diflunisal Diflunisal TABLET, FILM COATED ORAL 19921101 ANDA ANDA073673 Carilion Materials Management DIFLUNISAL 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68151-0984_4ea002b4-0da9-40c9-b1cd-36c29b156d5f 68151-0984 HUMAN PRESCRIPTION DRUG Methenamine Hippurate Methenamine Hippurate TABLET ORAL 20030701 ANDA ANDA076411 Carilion Materials Management METHENAMINE HIPPURATE 1 g/1 68151-0985_2e50b6c2-4b4e-4fa5-b916-c93b5760483b 68151-0985 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE, COATED ORAL 20010701 ANDA ANDA065028 Carilion Materials Management RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 68151-0995_f67dedc4-07da-403c-9f5b-439c20ff55e4 68151-0995 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Carilion Materials Management AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68151-1008_22a25362-1fb6-44a7-91ec-ff89ce22309c 68151-1008 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine hydrochloride SYRUP ORAL 20080724 ANDA ANDA078398 Carilion Materials Management CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 68151-1013_a08fd783-9a73-402b-8bd8-b45a68addce0 68151-1013 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Carilion Materials Management ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68151-1019_512a691b-3dba-43ce-8265-1f7f000d6ff8 68151-1019 HUMAN PRESCRIPTION DRUG Dilantin Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 19760827 ANDA ANDA084349 Carilion Materials Management PHENYTOIN SODIUM 30 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68151-1020_b0603993-03f4-4b9c-b86c-abe5913a7a87 68151-1020 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA AUTHORIZED GENERIC NDA019885 Carilion Materials Management QUINAPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68151-1021_24da567a-66d8-49c0-91b6-f9258eaa2f11 68151-1021 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA AUTHORIZED GENERIC NDA019885 Carilion Materials Management QUINAPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68151-1022_0e0c7ebe-bdf1-4e38-8ab0-7c25b1dbd032 68151-1022 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA AUTHORIZED GENERIC NDA019885 Carilion Materials Management QUINAPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68151-1164_4374de3e-ac4f-4d50-a202-3ea14f079d03 68151-1164 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 Carilion Materials Management DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68151-1170_8eb5a5b5-ec11-4db7-b4ff-3f1028e0e442 68151-1170 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 Carilion Materials Management ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68151-1174_a613594f-d5fe-4e88-9049-2b21824a061d 68151-1174 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 Carilion Materials Management ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68151-1176_5b184b1d-e798-43d8-ab24-976f69aee72e 68151-1176 HUMAN PRESCRIPTION DRUG Erythromycin Base Erythromycin TABLET, FILM COATED ORAL 20110906 ANDA ANDA061621 Carilion Materials Management ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68151-1281_7769db37-fb59-41a3-bce2-af11e382c104 68151-1281 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20060127 ANDA ANDA077122 Carilion Materials Management DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] 68151-1294_d94dd02c-a6c6-4f35-b663-c9bd335fd478 68151-1294 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 19970326 ANDA ANDA074461 Carilion Materials Management INDAPAMIDE 1.25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 68151-1305_80df79c7-dce2-4a70-830d-5b18c1c733c1 68151-1305 HUMAN PRESCRIPTION DRUG Bromocriptine mesylate Bromocriptine mesylate TABLET ORAL 20081001 ANDA ANDA077646 Carilion Materials Management BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 68151-1313_35f1bc62-d5d4-422f-b1bf-04b80a4a2cf9 68151-1313 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030827 ANDA ANDA040511 Carilion Materials Management ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 68151-1320_27f21670-5c58-4902-8327-b35020828720 68151-1320 HUMAN PRESCRIPTION DRUG Pindolol pindolol TABLET ORAL 19920903 ANDA ANDA074019 Carilion Materials Management PINDOLOL 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68151-1326_3a755dcc-08e8-4965-8290-d3d4187d50f7 68151-1326 HUMAN PRESCRIPTION DRUG Fluvastatin Sodium fluvastatin CAPSULE ORAL 20130319 ANDA ANDA090595 Carilion Materials Management FLUVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68151-1327_d277a6e5-f60f-4265-998d-6c662617d7b9 68151-1327 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine TABLET ORAL 20110101 ANDA ANDA077533 Carilion Materials Management TERBINAFINE HYDROCHLORIDE 250 1/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 68151-1333_3d8f2a9d-e940-469a-8bda-5f7a1dc85689 68151-1333 HUMAN PRESCRIPTION DRUG Isradipine Isradipine CAPSULE ORAL 20060105 ANDA ANDA077317 Carilion Materials Management ISRADIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68151-1334_935629c8-093f-44fc-a629-b1f920153213 68151-1334 HUMAN PRESCRIPTION DRUG Fluvastatin Sodium fluvastatin CAPSULE ORAL 20130319 ANDA ANDA090595 Carilion Materials Management FLUVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68151-1363_fbccf5a8-ac76-4a0c-862e-de13c826e454 68151-1363 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Carilion Materials Management AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68151-1364_31b57d26-77f3-4d79-af60-374f9b2ad1a1 68151-1364 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100205 ANDA ANDA078466 Carilion Materials Management AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68151-1365_21e57f79-f56c-490f-a0b7-40799e7e50f8 68151-1365 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Carilion Materials Management AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68151-1418_ab30ee1b-b482-40ab-8200-fded649c7c1a 68151-1418 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060330 ANDA ANDA076813 Carilion Materials Management ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68151-1437_da6076cb-d606-4903-8f5e-49e92d962c5c 68151-1437 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020228 ANDA ANDA075022 Carilion Materials Management BUSPIRONE HYDROCHLORIDE 5 mg/1 68151-1438_61e55ac3-ea61-46cf-bfb3-a95bd8e38f3f 68151-1438 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020228 ANDA ANDA075022 Carilion Materials Management BUSPIRONE HYDROCHLORIDE 10 mg/1 68151-1452_08022911-f431-47d9-a613-c644d546f01b 68151-1452 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20110808 ANDA ANDA076447 Carilion Materials Management FEXOFENADINE HYDROCHLORIDE 60 mg/1 68151-1463_327d8c6b-2bc1-4f54-9ea4-3d3572e6f0b6 68151-1463 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET ORAL 20000215 ANDA ANDA040327 Carilion Materials Management ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68151-1464_8d35d3f9-d75b-4389-9b38-68f8efd9177e 68151-1464 HUMAN PRESCRIPTION DRUG Flecainide Acetate flecainide acetate TABLET ORAL 20030114 ANDA ANDA076278 Carilion Materials Management FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] 68151-1471_827347b0-4c00-49f2-878f-ca5f72697e05 68151-1471 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL; SUBLINGUAL 20090921 UNAPPROVED DRUG OTHER Carilion Materials Management HYOSCYAMINE SULFATE .125 mg/1 68151-1472_568072e0-58cc-4225-912b-f0013c19370c 68151-1472 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET, FILM COATED ORAL 20030508 ANDA ANDA076204 Carilion Materials Management MOEXIPRIL HYDROCHLORIDE 7.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68151-1480_b2c7edda-beca-4c7d-bf19-cbf196ced2ce 68151-1480 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Carilion Materials Management DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68151-1487_23972e7f-2313-4524-b554-b930e51fed92 68151-1487 HUMAN PRESCRIPTION DRUG Nystatin Nystatin TABLET, FILM COATED ORAL 19900930 ANDA ANDA062506 Carilion Materials Management NYSTATIN 500000 [USP'U]/1 Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 68151-1494_86bb7a01-9ff0-4bea-8643-e40f1a482700 68151-1494 HUMAN PRESCRIPTION DRUG Dyrenium Triamterene CAPSULE ORAL 19991001 NDA NDA013174 Carilion Materials Management TRIAMTERENE 50 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] 68151-1497_75dc9419-1177-4afd-bbc1-f168cf6fa25e 68151-1497 HUMAN PRESCRIPTION DRUG Cimetidine cimetidine TABLET, FILM COATED ORAL 19940517 ANDA ANDA074246 Carilion Materials Management CIMETIDINE 200 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68151-1520_035af2dd-2489-4c0e-af78-53ded51e17bd 68151-1520 HUMAN PRESCRIPTION DRUG Dantrolene Sodium Dantrolene Sodium CAPSULE ORAL 20050301 ANDA ANDA076856 Carilion Materials Management DANTROLENE SODIUM 25 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] 68151-1521_869868ef-73db-4986-87a6-3f636676f92f 68151-1521 HUMAN PRESCRIPTION DRUG Etidronate Disodium etidronate disodium TABLET ORAL 20080102 ANDA ANDA075800 Carilion Materials Management ETIDRONATE DISODIUM 200 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 68151-1602_cdf01423-d033-452a-a862-61ae229ceac3 68151-1602 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Carilion Materials Management DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 68151-1603_f84faf86-75eb-4204-a801-da2a27177ac1 68151-1603 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Carilion Materials Management DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 68151-1610_4950d718-dff7-46b2-acdd-779257fc6570 68151-1610 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Carilion Materials Management RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68151-1712_37dba1f7-1117-4a6e-afe5-e8684883ae2c 68151-1712 HUMAN OTC DRUG Dimenhydrinate Dimenhydrinate TABLET ORAL 20040301 OTC MONOGRAPH FINAL part336 Carilion Materials Management DIMENHYDRINATE 50 mg/1 68151-1738_91720d96-0262-4f70-b731-c42f604f0fbb 68151-1738 HUMAN PRESCRIPTION DRUG Nitro-Time Nitroglycerin CAPSULE ORAL 20040129 UNAPPROVED DRUG OTHER Carilion Materials Management NITROGLYCERIN 9 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68151-1742_7246ff20-10de-42c4-9705-ac2889c77033 68151-1742 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20031124 ANDA ANDA074151 Carilion Materials Management CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68151-1840_81a67005-eb73-4722-8cfb-96b92d907fbf 68151-1840 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140101 ANDA ANDA090617 Carilion Materials Management METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68151-1923_e495fb85-bf37-4c6f-a9c9-31fd73dbe373 68151-1923 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20100924 UNAPPROVED DRUG OTHER Carilion Materials Management SALSALATE 500 mg/1 68151-1924_b6912c9b-480f-4b3a-ba7c-6d289a9bade4 68151-1924 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20100924 UNAPPROVED DRUG OTHER Carilion Materials Management SALSALATE 750 mg/1 68151-1929_aadceb6d-4dd3-49a0-b84e-20dec0de444f 68151-1929 HUMAN OTC DRUG ORGAN-I NR guaifenesin TABLET ORAL 20020701 OTC MONOGRAPH FINAL part341 Carilion Materials Management GUAIFENESIN 200 mg/1 68151-1977_a156e12b-8b55-4195-8c9c-0613a379ea06 68151-1977 HUMAN PRESCRIPTION DRUG Zafirlukast Zafirlukast TABLET, FILM COATED ORAL 20101118 ANDA ANDA090372 Carilion Materials Management ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68151-1980_bc50b130-12ad-4cc9-bad8-a322ec2cf5d4 68151-1980 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19830210 ANDA ANDA087946 Carilion Materials Management ISOSORBIDE DINITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68151-1991_35843ff3-e830-43ff-a9c0-ad7abdcbda15 68151-1991 HUMAN PRESCRIPTION DRUG Quinidine Sulfate Quinidine Sulfate TABLET ORAL 19761124 ANDA ANDA083288 Carilion Materials Management QUINIDINE SULFATE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] 68151-1992_5ef9ac99-fd51-4f37-8c2e-1875a1c0a52f 68151-1992 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110823 UNAPPROVED DRUG OTHER Carilion Materials Management PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 68151-1993_38db7765-dbeb-463a-a064-ece0c613780f 68151-1993 HUMAN PRESCRIPTION DRUG Probenecid probenecid TABLET, FILM COATED ORAL 19760113 ANDA ANDA084211 Carilion Materials Management PROBENECID 500 mg/1 68151-2007_0d791e94-6623-475d-a6a5-51bd00232964 68151-2007 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070027 Carilion Materials Management METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 68151-2010_6ca53b1d-9a7d-4c8f-921a-dbabc2c72ce2 68151-2010 HUMAN PRESCRIPTION DRUG Trimethoprim Trimethoprim TABLET ORAL 20100404 ANDA ANDA070049 Carilion Materials Management TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 68151-2016_2ee64601-bd15-44db-9ef2-6416f94c0168 68151-2016 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Carilion Materials Management PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68151-2022_9714b1c8-cd6b-43c2-afc9-5f2d8c70cc23 68151-2022 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840507 ANDA ANDA062396 Carilion Materials Management DOXYCYCLINE HYCLATE 100 mg/1 68151-2103_fc97c5f7-872a-4268-afdb-001dd07762c9 68151-2103 HUMAN PRESCRIPTION DRUG Rimantadine Hydrochloride Rimantadine Hydrochloride TABLET, FILM COATED ORAL 20050401 ANDA ANDA076132 Carilion Materials Management RIMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 68151-2111_367ce713-69d0-40e7-b32c-cb3fab54f238 68151-2111 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Carilion Materials Management DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68151-2112_f547b534-5451-4c02-8af5-2d2caaf828a7 68151-2112 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Carilion Materials Management DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68151-2113_021a4399-eb47-4b3d-b1d7-fdead43205cd 68151-2113 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Carilion Materials Management DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68151-2114_780c7da8-03a4-4da2-9c5d-49ec32beb0d7 68151-2114 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Carilion Materials Management DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68151-2195_93b368dc-b63f-40f5-84a5-da53f63d4554 68151-2195 HUMAN PRESCRIPTION DRUG Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate TABLET ORAL 20120628 UNAPPROVED DRUG OTHER Carilion Materials Management POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 155; 852; 130 mg/1; mg/1; mg/1 68151-2262_c6f5dc40-eb5d-4885-a97a-09bf27a7871c 68151-2262 HUMAN OTC DRUG Childrens Chewable Mapap Acetaminophen TABLET, CHEWABLE ORAL 20110504 OTC MONOGRAPH NOT FINAL part343 Carilion Materials Management ACETAMINOPHEN 80 mg/1 68151-2269_b0f9b7ea-bac2-427d-92fa-4ccf1b149332 68151-2269 HUMAN PRESCRIPTION DRUG HYDROCORTISONE hydrocortisone TABLET ORAL 20070330 ANDA ANDA040646 Carilion Materials Management HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68151-2298_79371e5b-3968-4c5d-9ef7-c78e92f64080 68151-2298 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 20050928 ANDA ANDA077246 Carilion Materials Management DANAZOL 200 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] 68151-2299_e2eccf74-1ad0-48cb-a2f5-055830d1e81f 68151-2299 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063065 Carilion Materials Management MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 68151-2346_b1b8b509-fc4c-4dae-be09-4a5b0f16b208 68151-2346 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100715 ANDA ANDA090931 Carilion Materials Management TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68151-2347_bd6eb1b5-511e-45e0-984b-9b93233dbf2a 68151-2347 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 19950605 ANDA ANDA074377 Carilion Materials Management MEXILETINE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC] 68151-2456_0381b7d6-b261-4c91-9399-bb31be8aa41d 68151-2456 HUMAN OTC DRUG Clemastine Fumarate Clemastine Fumarate TABLET ORAL 19931031 ANDA ANDA073458 Carilion Materials Management CLEMASTINE FUMARATE 1.34 mg/1 68151-2472_5d292f65-f875-4872-b755-e07da7e84df4 68151-2472 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086066 Carilion Materials Management ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68151-2475_56836c7b-981f-46e1-ba5c-8d0016a256c5 68151-2475 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086067 Carilion Materials Management ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68151-2476_b8be9baa-aebe-4ab1-a860-fcb1b91efff6 68151-2476 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19830210 ANDA ANDA087946 Carilion Materials Management ISOSORBIDE DINITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68151-2481_000e0356-cc97-4c3c-a0f7-57dcf0c52e30 68151-2481 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19950928 ANDA ANDA074376 Carilion Materials Management DICLOFENAC SODIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68151-2482_c6db5bfc-5d59-428a-8238-c9606a3e35d5 68151-2482 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880524 ANDA ANDA072099 Carilion Materials Management DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 68151-2486_7f48aaa3-111d-442c-9470-62fbd019daf1 68151-2486 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 19870623 ANDA ANDA071093 Carilion Materials Management THIOTHIXENE 5 mg/1 Typical Antipsychotic [EPC] 68151-2500_19269587-a4ad-4721-81b8-db2c3f89602a 68151-2500 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride and Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20090923 NDA AUTHORIZED GENERIC NDA012750 Carilion Materials Management CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] 68151-2502_8a839e5c-cbbf-42bd-bd92-cb4fcbceb148 68151-2502 HUMAN PRESCRIPTION DRUG Nitro-Time Nitroglycerin CAPSULE ORAL 20040129 UNAPPROVED DRUG OTHER Carilion Materials Management NITROGLYCERIN 2.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68151-2503_850e4cfc-b38b-47d3-ad77-be560954be75 68151-2503 HUMAN PRESCRIPTION DRUG Nitro-Time Nitroglycerin CAPSULE ORAL 20040129 UNAPPROVED DRUG OTHER Carilion Materials Management NITROGLYCERIN 6.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68151-2506_91201096-1429-489e-bfbd-7747adceaefe 68151-2506 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20100615 ANDA ANDA040644 Carilion Materials Management CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 68151-2510_3974c186-e804-431d-814e-fea7ef9d2ecf 68151-2510 HUMAN PRESCRIPTION DRUG ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE ORAL 20090922 ANDA ANDA040009 Carilion Materials Management ISOSORBIDE DINITRATE 40 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68151-2584_bbb10b8a-d224-4813-878f-5ee89e02f64e 68151-2584 HUMAN OTC DRUG Zantac 75 ranitidine TABLET, COATED ORAL 20061221 NDA NDA020520 Carilion Materials Management RANITIDINE HYDROCHLORIDE 75 mg/1 68151-2609_3a1f8d41-42f4-4194-88b2-cc109052bca4 68151-2609 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 19980729 ANDA ANDA075227 Carilion Materials Management NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68151-2640_70ce3a8c-7cbd-4c07-bb81-d77498883fe4 68151-2640 HUMAN PRESCRIPTION DRUG PRENATAL PLUS VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE TABLET, FILM COATED ORAL 20091202 UNAPPROVED DRUG OTHER Carilion Materials Management .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE; VITAMIN A ACETATE; ZINC OXIDE 22; 920; 120; 200; 400; 2; 12; 27; 1; 20; 10; 3; 1.84; 3080; 25 mg/1; [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 68151-2649_02102eb7-42a1-4dcd-b662-779a29580e56 68151-2649 HUMAN PRESCRIPTION DRUG SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE CAPSULE ORAL 20061104 ANDA ANDA075352 Carilion Materials Management SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] 68151-2694_d132ab2a-1616-4984-b277-e685a5fc0e1f 68151-2694 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20110401 ANDA ANDA091619 Carilion Materials Management DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] 68151-2701_1693e07a-1b5b-49df-bbf4-b0df822aed09 68151-2701 HUMAN PRESCRIPTION DRUG Quinidine Gluconate Quinidine Gluconate TABLET, EXTENDED RELEASE ORAL 19870210 ANDA ANDA089338 Carilion Materials Management QUINIDINE GLUCONATE 324 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] 68151-2702_b61812b9-c2e5-4462-ae85-e854d7260891 68151-2702 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Carilion Materials Management SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC] 68151-2713_6aa9625d-b53e-493b-ba83-6686b52ca8fb 68151-2713 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615 ANDA ANDA075273 Carilion Materials Management KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68151-2718_69ed5aa1-d77e-4067-be3f-3dd65718e7e6 68151-2718 HUMAN PRESCRIPTION DRUG itraconazole ITRACONAZOLE CAPSULE ORAL 20050201 NDA NDA020083 Carilion Materials Management ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68151-2749_36ef72d5-14b1-4eae-802e-4dd749930e0f 68151-2749 HUMAN OTC DRUG Bisacodyl Enteric Coated Bisacodyl TABLET, COATED ORAL 20081024 OTC MONOGRAPH NOT FINAL part334 Carilion Materials Management BISACODYL 5 mg/1 68151-2768_080d3af1-eb4a-4c23-bcb5-b30c26750861 68151-2768 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19831021 ANDA ANDA088292 Carilion Materials Management IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 68151-2780_0df17d77-73b8-4c83-aa20-cd2eb684e6d4 68151-2780 HUMAN PRESCRIPTION DRUG Ergoloid Mesylates Dihydroergocornine Mesylate, Dihydroergocristine Mesylate, Dihydro-.alpha.-ergocryptine mesylate, and Dihydro-.beta.-ergocryptine mesylate TABLET ORAL 19911031 ANDA ANDA081113 Carilion Materials Management DIHYDRO-.ALPHA.-ERGOCRYPTINE MESYLATE; DIHYDRO-.BETA.-ERGOCRYPTINE MESYLATE; DIHYDROERGOCORNINE MESYLATE; DIHYDROERGOCRISTINE MESYLATE .222; .111; .333; .333 mg/1; mg/1; mg/1; mg/1 68151-2781_e4f1bf86-6cc6-48db-b1e5-7eabe0d7c3ab 68151-2781 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19800107 ANDA ANDA083177 Carilion Materials Management HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68151-2857_ce40c3b5-1d3f-4625-8ae5-7c23adcb2c00 68151-2857 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071995 Carilion Materials Management PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68151-2870_81bf021b-a6f9-4a01-a725-2b1c441024a6 68151-2870 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE ORAL 20090811 ANDA ANDA072781 Carilion Materials Management NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68151-2871_b3d696fb-eb14-4e42-acb8-1e897397aeda 68151-2871 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 19900403 ANDA ANDA071795 Carilion Materials Management SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68151-2872_b383bc08-6a0a-43f8-b7ea-33c9b936cfcf 68151-2872 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 19900403 ANDA ANDA071795 Carilion Materials Management SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68151-2875_c88b8fa5-f602-43ca-8bb8-5d7fd7ac3712 68151-2875 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 19880615 ANDA ANDA072204 Carilion Materials Management LOXAPINE SUCCINATE 5 mg/1 68151-2894_4b3ab844-ac13-4428-8fc8-a692afb8a7bb 68151-2894 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Carilion Materials Management NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68151-2895_e8cb3c7e-636d-49a8-a3ef-b8967599788c 68151-2895 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Carilion Materials Management NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68151-2899_5d062dce-fe89-4d6f-b9b6-8fb4f71fa87a 68151-2899 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20040202 ANDA ANDA074151 Carilion Materials Management CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68151-2904_e501dcea-0440-4ff4-9841-d27292932c0f 68151-2904 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20091103 OTC MONOGRAPH FINAL part343 Carilion Materials Management ASPIRIN 81 mg/1 68151-2908_8ef4d40c-5adc-40db-8b2b-1c78cc662f83 68151-2908 HUMAN OTC DRUG Banophen Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 Carilion Materials Management DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 68151-2939_9e090d7a-7e02-4aec-b71f-daded0620ed6 68151-2939 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20041019 ANDA ANDA076698 Carilion Materials Management METOLAZONE 10 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 68151-2943_a1b63804-45df-451a-9cc2-15e0bb45e4b5 68151-2943 HUMAN PRESCRIPTION DRUG Zaroxolyn metolazone TABLET ORAL 19731127 NDA NDA017386 Carilion Materials Management METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 68151-2946_b0a54885-add7-4d27-b60d-86d8106aae75 68151-2946 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110101 ANDA ANDA079234 Carilion Materials Management TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 68151-2949_1406aef6-e37c-4a86-bb7c-868643828262 68151-2949 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110101 ANDA ANDA079234 Carilion Materials Management TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 68151-2958_5eb3f969-cde5-429e-95b0-6291e5c4167f 68151-2958 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20040527 ANDA ANDA076449 Carilion Materials Management MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 68151-2959_d114984b-bc2a-4647-be31-277dc1ea9c7a 68151-2959 HUMAN PRESCRIPTION DRUG Anagrelide Hydrochloride Anagrelide Hydrochloride CAPSULE ORAL 20050418 ANDA ANDA076468 Carilion Materials Management ANAGRELIDE HYDROCHLORIDE .5 mg/1 Decreased Platelet Production [PE],Platelet-reducing Agent [EPC],Phosphodiesterase 3 Inhibitors [MoA] 68151-2985_5b99391b-3e8e-4cf5-b66b-92d05527247f 68151-2985 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 19950605 ANDA ANDA074377 Carilion Materials Management MEXILETINE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] 68151-2986_907d1aee-2ecb-4d7b-96f5-24a0a254f726 68151-2986 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 19950605 ANDA ANDA074377 Carilion Materials Management MEXILETINE HYDROCHLORIDE 250 mg/1 Antiarrhythmic [EPC] 68151-2987_dedee131-e86a-4548-a12b-4e70f2bb0459 68151-2987 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 19871231 NDA AUTHORIZED GENERIC NDA019594 Carilion Materials Management URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 68151-2991_6e84badd-1946-4afd-bb0a-52a5cb7a628d 68151-2991 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19870218 ANDA ANDA071293 Carilion Materials Management AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 68151-3005_5b8abf6f-4aaf-4869-a2be-1e2466653823 68151-3005 HUMAN PRESCRIPTION DRUG Pindolol pindolol TABLET ORAL 19920903 ANDA ANDA074019 Carilion Materials Management PINDOLOL 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68151-3048_d4be8d00-37c0-48d6-b187-fe95cd144076 68151-3048 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Carilion Materials Management CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 68151-3063_fb2229d7-25bc-4798-b07a-793cb6e81fdf 68151-3063 HUMAN PRESCRIPTION DRUG Nephron FA mineral/vitamin supplement TABLET, COATED ORAL 19921101 UNAPPROVED DRUG OTHER Carilion Materials Management ASCORBIC ACID; BIOTIN; COBALAMIN; FOLIC ACID; IRON; NIACINAMIDE; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE 40; .3; .006; 1; 66; 20; 10; 10; 1.7; 1.5 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 68151-3071_be01775a-7100-4a99-8370-202073ec2b1a 68151-3071 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070810 ANDA ANDA078494 Carilion Materials Management PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68151-3083_df940283-205c-41b8-830a-896d48b6b948 68151-3083 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 ANDA ANDA075896 Carilion Materials Management FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68151-3110_e191b251-c4c0-46c6-bbb2-710f51a3368e 68151-3110 HUMAN PRESCRIPTION DRUG Methazolamide methazolamide TABLET ORAL 20100622 ANDA ANDA040062 Carilion Materials Management METHAZOLAMIDE 50 mg/1 68151-3112_952f74d2-4631-4033-98d7-a213a0d90494 68151-3112 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19920430 ANDA ANDA073281 Carilion Materials Management HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68151-3114_a40afc34-d10f-4553-ba73-e9866f4b290e 68151-3114 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 Carilion Materials Management DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68151-3118_6bc0d7c0-6a84-402d-a446-e995b67f5c2b 68151-3118 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA076273 Carilion Materials Management CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 68151-3120_23f7e297-0081-4501-abb5-fbe2caf10c10 68151-3120 HUMAN PRESCRIPTION DRUG Dipentum olsalazine sodium CAPSULE, GELATIN COATED ORAL 19900731 NDA NDA019715 Carilion Materials Management OLSALAZINE SODIUM 250 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 68151-3565_8b322aef-7cc0-477d-9d53-68132909cfa5 68151-3565 HUMAN PRESCRIPTION DRUG Prandin repaglinide TABLET ORAL 20000103 NDA NDA020741 Carilion Materials Management REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 68151-3566_179b453f-4a9c-4970-8f4b-ce084c748458 68151-3566 HUMAN PRESCRIPTION DRUG Prandin repaglinide TABLET ORAL 20000103 NDA NDA020741 Carilion Materials Management REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] 68151-3569_2a8808f6-4ca6-41d8-9205-16eded348d3f 68151-3569 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120330 ANDA ANDA077159 Carilion Materials Management IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68151-3591_276de0a3-febc-4414-a1ed-b27141ab1cc3 68151-3591 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070207 ANDA ANDA077489 Carilion Materials Management TRANDOLAPRIL 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68151-3645_1e3552c1-beca-4ce7-9177-27a77cb60310 68151-3645 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Carilion Materials Management PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68151-3646_b35de24c-6917-442e-8ed0-88bc79450d88 68151-3646 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20070511 ANDA ANDA076745 Carilion Materials Management OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 68151-3660_850426bd-8038-48c3-b947-2f0a8c6f0c8a 68151-3660 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110602 NDA AUTHORIZED GENERIC NDA020699 Carilion Materials Management VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68151-3792_3ef3a1bb-7da0-4e2e-9913-1ceb4d02b0f9 68151-3792 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 Carilion Materials Management PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 68151-3798_7b3823e9-474e-47d6-841f-ff75f0fb3052 68151-3798 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 Carilion Materials Management PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 68151-3826_d19ab868-f012-410e-ac35-48e6b33433f9 68151-3826 HUMAN PRESCRIPTION DRUG FLAVOXATE HYDROCHLORIDE FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED ORAL 20041222 ANDA ANDA076831 Carilion Materials Management FLAVOXATE HYDROCHLORIDE 100 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 68151-3834_b8921358-76a5-4dd3-89b8-f579e2c69272 68151-3834 HUMAN PRESCRIPTION DRUG AcipHex rabeprazole sodium TABLET, DELAYED RELEASE ORAL 19990819 NDA NDA020973 Carilion Materials Management RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68151-3838_88545675-1b7b-4311-946a-186cc26370b0 68151-3838 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 ANDA ANDA078702 Carilion Materials Management CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68151-3844_9382f1af-be95-4093-a3c0-16975044166c 68151-3844 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20050517 ANDA ANDA077024 Carilion Materials Management CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 68151-3858_f266bedc-4724-405e-924f-48884944b922 68151-3858 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 19900930 ANDA ANDA070101 Carilion Materials Management DISOPYRAMIDE PHOSPHATE 100 mg/1 Antiarrhythmic [EPC] 68151-3966_4ed7a60a-84d1-4cbc-b935-aaeda1bd52a9 68151-3966 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Carilion Materials Management PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68151-3971_fad4036a-e9d2-402b-b614-2e1eae5621cd 68151-3971 HUMAN PRESCRIPTION DRUG Aggrenox aspirin and dipyridamole CAPSULE ORAL 19991219 NDA NDA020884 Carilion Materials Management ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 68151-3977_4a7b69a0-d6e0-4b5c-98f5-8e54eb78bf20 68151-3977 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110422 ANDA ANDA076447 Carilion Materials Management FEXOFENADINE HYDROCHLORIDE 180 mg/1 68151-4021_8fa8950e-66eb-4dce-bf2d-07711b65f26a 68151-4021 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20070716 ANDA ANDA040761 Carilion Materials Management HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68151-4068_97bea64c-c8e2-4c8c-9586-430b7b19015a 68151-4068 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100629 NDA NDA020381 Carilion Materials Management NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 68151-4069_689b04f5-4d65-4b73-9200-8d217038df7d 68151-4069 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970728 NDA NDA020381 Carilion Materials Management NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 68151-4071_ecd47bea-9394-4ffc-add6-b7d578c18cab 68151-4071 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Carilion Materials Management ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68151-4072_21c3a12f-954b-4c57-9dfa-0041f51290a6 68151-4072 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Carilion Materials Management ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68151-4073_eb92db26-c812-4ddc-81e7-8429405f2bdd 68151-4073 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Carilion Materials Management ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68151-4123_c2218108-b69d-40aa-8563-9e0cbfd7757e 68151-4123 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20110105 ANDA ANDA077024 Carilion Materials Management CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 68151-4134_39488779-1bd1-4a3a-8e0a-523826a7c14f 68151-4134 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077131 Carilion Materials Management RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68151-4145_b3e2c633-6cfb-4b5d-8661-14c2ce8d7bb5 68151-4145 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914 NDA NDA020838 Carilion Materials Management CANDESARTAN CILEXETIL 4 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68151-4146_1b78d297-67bc-441a-83aa-0ac9c21b8788 68151-4146 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914 NDA NDA020838 Carilion Materials Management CANDESARTAN CILEXETIL 8 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68151-4210_2b7acf3b-fc64-457e-873f-0b75d7c05e47 68151-4210 HUMAN PRESCRIPTION DRUG Theophylline (Anhydrous) Theophylline TABLET, EXTENDED RELEASE ORAL 20070601 ANDA ANDA040560 Carilion Materials Management THEOPHYLLINE ANHYDROUS 600 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 68151-4223_5816a51b-9d21-4b81-951d-162937a6244a 68151-4223 HUMAN PRESCRIPTION DRUG Afeditab CR Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021101 ANDA ANDA075128 Carilion Materials Management NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68151-4235_f1a2f121-c73e-475f-b3e1-1ea5eef3ba3f 68151-4235 HUMAN PRESCRIPTION DRUG GABITRIL tiagabine hydrochloride TABLET ORAL 19971103 NDA NDA020646 Carilion Materials Management TIAGABINE HYDROCHLORIDE 4 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68151-4243_94a27e1f-b271-4b0a-985e-6ec525416e3c 68151-4243 HUMAN PRESCRIPTION DRUG MagneBind 400 Rx vitamin/mineral supplement with magnesium carbonate, calcium carbonate and folic acid TABLET, FILM COATED ORAL 19991018 UNAPPROVED DRUG OTHER Carilion Materials Management CALCIUM CARBONATE; FOLIC ACID; MAGNESIUM CARBONATE 80; 1; 115 mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 68151-4249_103ce92a-9e5b-4a81-b870-31994ad03b51 68151-4249 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20080828 ANDA ANDA076420 Carilion Materials Management LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68151-4290_edde3061-931c-4b39-af25-6f1f41fa3a0e 68151-4290 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Carilion Materials Management LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68151-4319_de33dd7e-4623-434e-aa6b-523acce8702d 68151-4319 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 Carilion Materials Management MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68151-4338_27fdb232-6189-4a53-9ed8-179cf8c887a1 68151-4338 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA078723 Carilion Materials Management MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 68151-4349_27bac5f0-4dda-4f01-b03f-b1ae236eda1b 68151-4349 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Carilion Materials Management VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68151-4361_5079bf70-2e40-473c-b324-e07a4697039d 68151-4361 HUMAN PRESCRIPTION DRUG Colestipol Hydrochloride Colestipol Hydrochloride TABLET ORAL 19940719 NDA AUTHORIZED GENERIC NDA020222 Carilion Materials Management COLESTIPOL HYDROCHLORIDE 1 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 68151-4362_81f3e246-f8c9-418b-ba6d-0940b92da088 68151-4362 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride TABLET, FILM COATED ORAL 20000901 NDA NDA021176 Carilion Materials Management COLESEVELAM HYDROCHLORIDE 625 mg/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] 68151-4374_4e0daaa9-b926-4033-93c4-47fefd919ed3 68151-4374 HUMAN PRESCRIPTION DRUG Budesonide budesonide CAPSULE ORAL 20130823 ANDA ANDA090410 Carilion Materials Management BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68151-4461_9e339850-8d9f-4e5e-a4d2-f4f6927b4794 68151-4461 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Carilion Materials Management ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] 68151-4471_28e0a855-0be8-480d-9aaf-bdf8be6d2df1 68151-4471 HUMAN PRESCRIPTION DRUG Lescol XL fluvastatin sodium TABLET, EXTENDED RELEASE ORAL 20001006 NDA NDA021192 Carilion Materials Management FLUVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68151-4474_4b462464-40ce-4fd7-b054-10cd0e2be86b 68151-4474 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20110916 ANDA ANDA201680 Carilion Materials Management FELBAMATE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68151-4484_e0dfed21-1067-40b2-b482-210d7c971dc8 68151-4484 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 Carilion Materials Management ATOMOXETINE HYDROCHLORIDE 10 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 68151-4485_14eceffd-5c83-412c-a92c-16242be39f1f 68151-4485 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 Carilion Materials Management ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 68151-4486_5abe983f-099f-43c0-a0d3-d7afbdf115f8 68151-4486 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 Carilion Materials Management ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 68151-4487_65551c3d-2206-4944-80f9-8168ee604157 68151-4487 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 Carilion Materials Management ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 68151-4488_666d35f8-531c-4283-b4ea-b46f9e332846 68151-4488 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 Carilion Materials Management ATOMOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] 68151-4504_e3845c28-be37-4c20-8060-f2934ac581e7 68151-4504 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol fumarate TABLET ORAL 20090921 ANDA ANDA078635 Carilion Materials Management BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68151-4633_fc9a33e8-e4ad-4aec-a813-4ab7f493d5a4 68151-4633 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 Carilion Materials Management OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68151-4634_7c43d4c3-6be3-4a73-af0c-0452cb537d8e 68151-4634 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 Carilion Materials Management ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68151-4668_65425d27-f4a7-4341-b5e1-3a4d3f38245f 68151-4668 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 Carilion Materials Management METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68151-4672_b7f87c63-31c5-4a1a-952d-d4cff5403c74 68151-4672 HUMAN OTC DRUG Pain Reliever Plus Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Carilion Materials Management ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 68151-4679_2af07bd5-1130-48d9-a921-6241bb705307 68151-4679 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Carilion Materials Management DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68151-4717_4fc55876-2aa7-448f-82a6-0f75a7de15b5 68151-4717 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20041105 NDA AUTHORIZED GENERIC NDA021656 Carilion Materials Management FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68151-4718_fd016156-c999-4336-b6de-cd5bb030f692 68151-4718 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20041105 NDA AUTHORIZED GENERIC NDA021656 Carilion Materials Management FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68151-4727_9a379a19-a042-42b5-a8b3-52a0f384de06 68151-4727 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140124 NDA AUTHORIZED GENERIC NDA021427 Carilion Materials Management DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68151-4734_ea281201-a47d-48b5-8448-a086cafc2523 68151-4734 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Carilion Materials Management DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68151-4740_f02b07f6-ba0b-45b6-a1fd-79246692a947 68151-4740 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20040404 NDA NDA021688 Carilion Materials Management CINACALCET HYDROCHLORIDE 30 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] 68151-4760_30799fb0-c3e1-4b6e-9b30-5f30409b2b6d 68151-4760 HUMAN PRESCRIPTION DRUG Campral acamprosate calcium TABLET, DELAYED RELEASE ORAL 20050111 NDA NDA021431 Carilion Materials Management ACAMPROSATE CALCIUM 333 mg/1 68151-4769_80e3db92-9352-4e40-9d7e-4b37635ee685 68151-4769 HUMAN PRESCRIPTION DRUG Pentasa mesalamine CAPSULE ORAL 19930510 NDA NDA020049 Carilion Materials Management MESALAMINE 250 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 68151-4952_3770c497-6575-41e9-b795-a60ad5ff2e51 68151-4952 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate TABLET, FILM COATED ORAL 20060510 NDA NDA021928 Carilion Materials Management VARENICLINE TARTRATE 1 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] 68151-4953_88048960-8979-4063-8bbf-6000b8cf3c1a 68151-4953 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate TABLET, FILM COATED ORAL 20060510 NDA NDA021928 Carilion Materials Management VARENICLINE TARTRATE .5 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] 68151-4980_07b73f90-1ccb-4246-b635-a4dbe7798a4d 68151-4980 HUMAN PRESCRIPTION DRUG XIFAXAN RIFAXIMIN TABLET ORAL 20040725 NDA NDA021361 Carilion Materials Management RIFAXIMIN 200 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 68151-4982_6a629958-4f09-4827-8c62-95da3c614bf1 68151-4982 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Carilion Materials Management ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] 68151-5003_fa77ef52-a1a1-485e-96d4-cf2ff432a991 68151-5003 HUMAN PRESCRIPTION DRUG Amitiza lubiprostone CAPSULE, GELATIN COATED ORAL 20060131 NDA NDA021908 Carilion Materials Management LUBIPROSTONE 24 ug/1 Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] 68151-5004_0d137e3d-b4cf-48ba-8d35-f9aa7c100b9c 68151-5004 HUMAN PRESCRIPTION DRUG Ranexa RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060127 NDA NDA021526 Carilion Materials Management RANOLAZINE 500 mg/1 Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 68151-5026_38554d9e-d106-4280-9c55-685a5d076f55 68151-5026 HUMAN PRESCRIPTION DRUG Dexamethasone Intensol Dexamethasone Intensol SOLUTION, CONCENTRATE ORAL 19830901 ANDA ANDA088252 Carilion Materials Management DEXAMETHASONE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68151-5044_e716c1ec-2978-479c-9721-c77de309c791 68151-5044 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Carilion Materials Management VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68151-5048_73197e5a-af6e-4ffd-b1ed-98eefafc923a 68151-5048 HUMAN PRESCRIPTION DRUG COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070209 NDA NDA022012 Carilion Materials Management CARVEDILOL PHOSPHATE 10 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68151-5049_dae5631a-0856-4ace-8f6c-250b930cec22 68151-5049 HUMAN PRESCRIPTION DRUG COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070206 NDA NDA022012 Carilion Materials Management CARVEDILOL PHOSPHATE 20 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68151-5050_13fc879d-3129-4cbc-9778-6cccee67ff61 68151-5050 HUMAN PRESCRIPTION DRUG COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070214 NDA NDA022012 Carilion Materials Management CARVEDILOL PHOSPHATE 40 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68151-5051_58250bb0-cd47-43cd-a48d-55dbf0f7d6a1 68151-5051 HUMAN PRESCRIPTION DRUG COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070220 NDA NDA022012 Carilion Materials Management CARVEDILOL PHOSPHATE 80 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68151-5113_0c5475fd-ad5d-4051-a797-f97db85fd4bb 68151-5113 HUMAN PRESCRIPTION DRUG Renvela SEVELAMER CARBONATE TABLET, FILM COATED ORAL 20090812 NDA NDA022127 Carilion Materials Management SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 68151-5121_29164c8c-b130-4750-b500-41e4227840be 68151-5121 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Carilion Materials Management ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] 68151-5182_3eb793d8-dc08-4995-940d-c41e2afa3b73 68151-5182 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Extended-Release Hyoscyamine Sulfate Extended-Release TABLET ORAL 20100103 UNAPPROVED DRUG OTHER Carilion Materials Management HYOSCYAMINE SULFATE .375 mg/1 68151-5204_92caf563-66f1-43d4-a842-bcde36107f7a 68151-5204 HUMAN PRESCRIPTION DRUG Eliphos Calcium Acetate TABLET ORAL 20090201 ANDA ANDA078502 Carilion Materials Management CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 68151-5230_c31c9215-88c2-4fdf-b671-3def8f4a3c00 68151-5230 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20090801 ANDA ANDA077789 Carilion Materials Management CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] 68151-5652_ab0d9e65-3308-4a7c-a1dd-9d2dd65d1cdc 68151-5652 HUMAN PRESCRIPTION DRUG Delzicol mesalamine CAPSULE, DELAYED RELEASE ORAL 20130301 NDA NDA204412 Carilion Materials Management MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 68152-101_47e3f48c-6c9e-4116-94a7-a08d4ffa4f6f 68152-101 HUMAN PRESCRIPTION DRUG Fusilev levoleucovorin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080815 NDA NDA020140 Spectrum Pharmaceuticals, Inc. LEVOLEUCOVORIN CALCIUM 50 mg/5mL 68152-102_47e3f48c-6c9e-4116-94a7-a08d4ffa4f6f 68152-102 HUMAN PRESCRIPTION DRUG Fusilev levoleucovorin INJECTION, SOLUTION INTRAVENOUS 20110915 NDA NDA020140 Spectrum Pharmaceuticals, Inc. LEVOLEUCOVORIN CALCIUM 10 mg/mL 68152-103_3bf849c2-1738-43e9-bec1-3f6c86e8ff02 68152-103 HUMAN PRESCRIPTION DRUG Zevalin ibritumomab tiuxetan KIT 20020219 BLA BLA125019 Spectrum Pharmaceuticals, Inc. 68152-108_d757b960-71d5-44a7-a490-744bd04e95ef 68152-108 HUMAN PRESCRIPTION DRUG Beleodaq Belinostat INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140721 NDA NDA206256 Spectrum Pharmaceuticals, Inc. BELINOSTAT 500 mg/10mL 68163-081_6bcbff93-c2b7-4ffa-bd41-5e6bc08f7ff9 68163-081 HUMAN OTC DRUG Chewable Adult Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 20130603 OTC MONOGRAPH FINAL part343 Raritan Pharmaceuticals Inc ASPIRIN 81 mg/1 68163-709_893fa061-ba83-485e-a9dc-822313b6065d 68163-709 HUMAN OTC DRUG equate infants gas relief Simethicone EMULSION ORAL 20100308 OTC MONOGRAPH FINAL part332 Raritan Pharmaceuticals Inc DIMETHICONE 20 mg/.3mL 68169-0012_6a31f3f5-eb6e-44de-878c-9994d9acefac 68169-0012 HUMAN OTC DRUG TODAYS HEALTH SINUS NASAL RELIEF OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20101025 OTC MONOGRAPH FINAL part341 TAI GUK PHARM. CO., LTD. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 68169-0013_856cfbbe-f4c8-4266-9792-b8dffe01fbad 68169-0013 HUMAN OTC DRUG TODAYS HEALTH NASAL RELIEF ORIGINAL OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20101022 OTC MONOGRAPH FINAL part341 TAI GUK PHARM. CO., LTD. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 68169-0014_0de2a331-16a4-4d80-9dcb-0704c226ff27 68169-0014 HUMAN OTC DRUG TODAYS HEALTH NASAL RELIEF EXTRA MOISTURIZING OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20101111 OTC MONOGRAPH FINAL part341 TAI GUK PHARM. CO., LTD. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL 68169-0022_cb15cade-4fca-43a3-b4fb-835c9f0f5f7f 68169-0022 HUMAN OTC DRUG SHOPKO TRIPLE ANTIBIOTIC BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE OINTMENT TOPICAL 20101220 OTC MONOGRAPH FINAL part333B TAI GUK PHARM. CO., LTD. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 68169-0049_b99dff4c-9cf4-45f8-ab70-4d5450b85235 68169-0049 HUMAN OTC DRUG FAMILY CARE ANTI-ITCH DIPHENHYDRAMINE HYDROCHLORIDE CREAM TOPICAL 20100416 OTC MONOGRAPH NOT FINAL part348 TAI GUK PHARM. CO., LTD. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/g; mg/g 68169-0061_27e2df4e-a743-4083-a3c4-3fd75efc9f0d 68169-0061 HUMAN OTC DRUG FIRST AID RESEARCH ZINC OXYDE PLUS MENTHOL AND ZINC OXIDE OINTMENT TOPICAL 20100928 OTC MONOGRAPH FINAL part347 TAI GUK PHARM. CO., LTD. MENTHOL; ZINC OXIDE .44; 20 g/100g; g/100g 68169-0094_f6c32a94-75b4-488e-be1f-fc5f43ba6a8e 68169-0094 HUMAN OTC DRUG First Aid Research Bacitracin with Zinc Bacitracin Zinc OINTMENT TOPICAL 20100407 OTC MONOGRAPH FINAL part333 TAI GUK PHARM. CO., LTD. BACITRACIN ZINC 500 [iU]/g 68169-0127_8f6ba017-40c2-4a36-999a-886a1df70cca 68169-0127 HUMAN OTC DRUG PREMIER VALUE ALLERGY DIPHENHYDRAMINE HYDROCHLORIDE CREAM TOPICAL 20100917 OTC MONOGRAPH NOT FINAL part348 TAI GUK PHARM. CO., LTD. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g 68169-0128_e67f37e1-e527-4045-b3eb-689f4addfcc4 68169-0128 HUMAN OTC DRUG PREMIER VALUE DIAPER RASH ZINC OXIDE OINTMENT TOPICAL 20100930 OTC MONOGRAPH FINAL part347 TAI GUK PHARM. CO., LTD. ZINC OXIDE .4 g/g 68169-0129_c6606008-f13d-47f0-b836-4459b05021a9 68169-0129 HUMAN OTC DRUG PREMIER VALUE TRIPLE ANTIBIOTIC PLUS BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE OINTMENT TOPICAL 20101104 OTC MONOGRAPH FINAL part333B TAI GUK PHARM. CO., LTD. BACITRACIN ZINC; NEOMYCIN; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g 68169-0130_8dabf91e-3a88-4053-8e9b-a8ef6b51f103 68169-0130 HUMAN OTC DRUG PREMIER VALUE ZINC OXIDE ZINC OXIDE OINTMENT TOPICAL 20101108 OTC MONOGRAPH FINAL part347 TAI GUK PHARM. CO., LTD. ZINC OXIDE 20 g/100g 68169-0375_65933290-eab5-456c-9ea5-c9d5ff3c614c 68169-0375 HUMAN OTC DRUG WESTERN FAMILY DIAPER RASH ZINC OXIDE OINTMENT TOPICAL 20101005 OTC MONOGRAPH FINAL part347 TAI GUK PHARM. CO., LTD. ZINC OXIDE .4 g/g 68169-3050_87aecaaf-36ab-452c-bf89-cb5e3ac3a4c2 68169-3050 HUMAN OTC DRUG DG ATHLETES FOOT TOLNAFTATE CREAM TOPICAL 20101210 OTC MONOGRAPH FINAL part333C TAI GUK PHARM. CO., LTD. TOLNAFTATE 10 mg/g 68169-3229_026cca97-9385-4bc9-9465-e439cb40586a 68169-3229 HUMAN OTC DRUG BEING WELL DIAPER RASH CREAMY ZINC OXIDE OINTMENT TOPICAL 20101117 OTC MONOGRAPH FINAL part347 TAI GUK PHARM. CO., LTD. ZINC OXIDE .1 g/g 68169-4058_e1503304-00b8-4364-b435-0d1ed448eff3 68169-4058 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY DIAPER RASH ZINC OXIDE CREAM TOPICAL 20100920 OTC MONOGRAPH FINAL part347 TAI GUK PHARM. CO., LTD. ZINC OXIDE .1 g/g 68169-4059_5b8845a7-3d0a-4583-92b0-d875546394f5 68169-4059 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY ACNE TREATMENT BENZOYL PEROXIDE CREAM TOPICAL 20101117 OTC MONOGRAPH NOT FINAL part333D TAI GUK PHARM. CO., LTD. BENZOYL PEROXIDE 10 g/100g 68169-9930_4a7f4a56-1609-4ae0-9a2f-ff15d47cec32 68169-9930 HUMAN OTC DRUG CVS CHILDREN DECONGESTANT NOSE DROPS PHENYLEPHRINE HYDROCHLORIDE SOLUTION NASAL 20100712 OTC MONOGRAPH FINAL part341 TAI GUK PHARM. CO., LTD. PHENYLEPHRINE HYDROCHLORIDE 1.25 mg/mL 68180-099_cc6bc3f7-f9cc-4bbd-832e-eb5eee1f7b22 68180-099 HUMAN PRESCRIPTION DRUG levetiracetam levetiracetam SOLUTION ORAL 20141101 ANDA ANDA090893 Lupin Pharmaceuticals, Inc. LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68180-101_7d664852-33b3-455a-aa09-2d0b031ae491 68180-101 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-102_7d664852-33b3-455a-aa09-2d0b031ae491 68180-102 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-103_7d664852-33b3-455a-aa09-2d0b031ae491 68180-103 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-104_7d664852-33b3-455a-aa09-2d0b031ae491 68180-104 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-105_7d664852-33b3-455a-aa09-2d0b031ae491 68180-105 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-112_425d8b2b-0bb0-4a2a-a9bc-9c1d14ce3274 68180-112 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Lupin Pharmaceuticals, Inc. LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68180-113_425d8b2b-0bb0-4a2a-a9bc-9c1d14ce3274 68180-113 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Lupin Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68180-114_425d8b2b-0bb0-4a2a-a9bc-9c1d14ce3274 68180-114 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Lupin Pharmaceuticals, Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68180-115_425d8b2b-0bb0-4a2a-a9bc-9c1d14ce3274 68180-115 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA090025 Lupin Pharmaceuticals, Inc. LEVETIRACETAM 1000 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68180-116_cc6bc3f7-f9cc-4bbd-832e-eb5eee1f7b22 68180-116 HUMAN PRESCRIPTION DRUG levetiracetam levetiracetam SOLUTION ORAL 20130125 20160731 ANDA ANDA090893 Lupin Pharmaceuticals, Inc. LEVETIRACETAM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68180-117_0ec567ac-9f44-4b97-92af-1bb615d146fb 68180-117 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091399 Lupin Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68180-118_0ec567ac-9f44-4b97-92af-1bb615d146fb 68180-118 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091399 Lupin Pharmaceuticals, Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68180-121_b3e46a2a-9085-493d-806c-efcb5b3736e8 68180-121 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060111 ANDA ANDA065229 Lupin Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-122_b3e46a2a-9085-493d-806c-efcb5b3736e8 68180-122 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060111 ANDA ANDA065229 Lupin Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-123_1931758d-6ab8-4242-a3c7-97bb797468a2 68180-123 HUMAN PRESCRIPTION DRUG cephalexin Cephalexin FOR SUSPENSION ORAL 20060111 ANDA ANDA065234 Lupin Pharmaceuticals, Inc. CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-124_1931758d-6ab8-4242-a3c7-97bb797468a2 68180-124 HUMAN PRESCRIPTION DRUG cephalexin Cephalexin FOR SUSPENSION ORAL 20060111 ANDA ANDA065234 Lupin Pharmaceuticals, Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-128_eb7a3782-739f-40c4-b3bb-2435605bf195 68180-128 HUMAN PRESCRIPTION DRUG Fenofibric acid Fenofibric acid CAPSULE, DELAYED RELEASE ORAL 20131217 ANDA ANDA200750 Lupin Pharmaceuticals, Inc. CHOLINE FENOFIBRATE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68180-129_eb7a3782-739f-40c4-b3bb-2435605bf195 68180-129 HUMAN PRESCRIPTION DRUG Fenofibric acid Fenofibric acid CAPSULE, DELAYED RELEASE ORAL 20131217 ANDA ANDA200750 Lupin Pharmaceuticals, Inc. CHOLINE FENOFIBRATE 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68180-130_178c521e-e5c1-4f95-ab72-b1529e65eab5 68180-130 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20130222 NDA AUTHORIZED GENERIC NDA021695 Lupin Pharmaceuticals, Inc. FENOFIBRATE 43 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68180-131_178c521e-e5c1-4f95-ab72-b1529e65eab5 68180-131 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20130222 NDA AUTHORIZED GENERIC NDA021695 Lupin Pharmaceuticals, Inc. FENOFIBRATE 130 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68180-135_8dd42c82-8266-425a-b5ee-2f1d56105ce4 68180-135 HUMAN PRESCRIPTION DRUG Escitalopram Escitslopram TABLET ORAL 20120910 ANDA ANDA078169 Lupin Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68180-136_8dd42c82-8266-425a-b5ee-2f1d56105ce4 68180-136 HUMAN PRESCRIPTION DRUG Escitalopram Escitslopram TABLET ORAL 20120910 ANDA ANDA078169 Lupin Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68180-137_8dd42c82-8266-425a-b5ee-2f1d56105ce4 68180-137 HUMAN PRESCRIPTION DRUG Escitalopram Escitslopram TABLET ORAL 20120910 ANDA ANDA078169 Lupin Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68180-141_08289303-96b2-465b-b493-ee10b68be6b4 68180-141 HUMAN PRESCRIPTION DRUG Nabumetone nabumetone TABLET, FILM COATED ORAL 20120827 ANDA ANDA090445 Lupin Pharmaceuticals, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68180-142_08289303-96b2-465b-b493-ee10b68be6b4 68180-142 HUMAN PRESCRIPTION DRUG Nabumetone nabumetone TABLET, FILM COATED ORAL 20120827 ANDA ANDA090445 Lupin Pharmaceuticals, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68180-150_77c29140-f626-4c61-a461-6672e72b305d 68180-150 HUMAN PRESCRIPTION DRUG Famotidine Famotidine POWDER, FOR SUSPENSION ORAL 20100629 ANDA ANDA090440 Lupin Pharmaceuticals, Inc FAMOTIDINE 40 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68180-153_6e073a74-2390-41d3-a015-001c8a574f59 68180-153 HUMAN PRESCRIPTION DRUG DESLORATADINE DESLORATADINE TABLET, FILM COATED ORAL 20130214 ANDA ANDA078352 Lupin Pharmaceuticals, Inc. DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 68180-180_4eadb52a-4d0d-49c7-b55f-11b756cfbda0 68180-180 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20080423 ANDA ANDA065392 Lupin Pharmaceuticals, Inc. CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-181_6f07c5ed-ed94-4fb4-a3dc-d3a594b12910 68180-181 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20080423 ANDA ANDA065396 Lupin Pharmaceuticals, Inc. CEFADROXIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-182_6f07c5ed-ed94-4fb4-a3dc-d3a594b12910 68180-182 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20080423 ANDA ANDA065396 Lupin Pharmaceuticals, Inc. CEFADROXIL 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-185_5cee7ad9-b9a8-4a17-8162-8cff7e30c32d 68180-185 HUMAN PRESCRIPTION DRUG Mefenamic Acid Mefenamic Acid CAPSULE ORAL 20110722 ANDA ANDA091322 LUPIN PHARMACEUTICALS INC MEFENAMIC ACID 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68180-193_ed45d4b2-d5f5-40a5-9279-353d2d6f9528 68180-193 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20140807 ANDA ANDA091351 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 40 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-194_ed45d4b2-d5f5-40a5-9279-353d2d6f9528 68180-194 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20140807 ANDA ANDA091351 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 80 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-195_ed45d4b2-d5f5-40a5-9279-353d2d6f9528 68180-195 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20140807 ANDA ANDA091351 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 25; 80 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-196_67dc5329-5b24-4d45-8c2b-80e99cc3ffc6 68180-196 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA201586 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; TELMISARTAN 5; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68180-197_67dc5329-5b24-4d45-8c2b-80e99cc3ffc6 68180-197 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA201586 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; TELMISARTAN 10; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68180-198_67dc5329-5b24-4d45-8c2b-80e99cc3ffc6 68180-198 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA201586 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; TELMISARTAN 5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68180-199_67dc5329-5b24-4d45-8c2b-80e99cc3ffc6 68180-199 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA201586 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; TELMISARTAN 10; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68180-202_73b4ac79-6e4f-464e-853c-eab65a8b7a38 68180-202 HUMAN PRESCRIPTION DRUG SUPRAX CEFIXIME POWDER, FOR SUSPENSION ORAL 20040301 ANDA ANDA065129 Lupin Pharmaceuticals, Inc. CEFIXIME 100 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-210_f506a4a9-bf18-4160-9b02-75f94a631daf 68180-210 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA078232 Lupin Pharmaceuticals, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-211_f506a4a9-bf18-4160-9b02-75f94a631daf 68180-211 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA078232 Lupin Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-212_f506a4a9-bf18-4160-9b02-75f94a631daf 68180-212 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA078232 Lupin Pharmaceuticals, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-215_c17354f9-92f3-487d-b33f-27b5707c4fe4 68180-215 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA078245 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-216_c17354f9-92f3-487d-b33f-27b5707c4fe4 68180-216 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA078245 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-217_c17354f9-92f3-487d-b33f-27b5707c4fe4 68180-217 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA078245 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-220_b6cd089a-94a4-47a4-9fb2-cb21fe56fb71 68180-220 HUMAN PRESCRIPTION DRUG RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA078964 Lupin Pharmaceuticals, Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68180-221_d1b25c10-ddbb-4dd4-a380-d1436bb1a639 68180-221 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, EXTENDED RELEASE ORAL 20140320 ANDA ANDA090860 Lupin Pharmaceuticals, Inc. NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 68180-222_d1b25c10-ddbb-4dd4-a380-d1436bb1a639 68180-222 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, EXTENDED RELEASE ORAL 20140320 ANDA ANDA090892 Lupin Pharmaceuticals, Inc. NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 68180-223_d1b25c10-ddbb-4dd4-a380-d1436bb1a639 68180-223 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, EXTENDED RELEASE ORAL 20140320 ANDA ANDA090446 Lupin Pharmaceuticals, Inc. NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 68180-235_fbb31482-9ac8-48c6-b814-5d467f22051b 68180-235 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20100315 ANDA ANDA078263 Lupin Pharmaceuticals, Inc PERINDOPRIL ERBUMINE 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-236_fbb31482-9ac8-48c6-b814-5d467f22051b 68180-236 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20100315 ANDA ANDA078263 Lupin Pharmaceuticals, Inc PERINDOPRIL ERBUMINE 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-237_fbb31482-9ac8-48c6-b814-5d467f22051b 68180-237 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20100315 ANDA ANDA078263 Lupin Pharmaceuticals, Inc PERINDOPRIL ERBUMINE 8 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-240_5c8549a4-9f30-4c2b-92ca-ee87ef6a9822 68180-240 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA078424 Lupin Pharmaceuticals, Inc. LEVOFLOXACIN 250 mg/1 68180-241_5c8549a4-9f30-4c2b-92ca-ee87ef6a9822 68180-241 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA078424 Lupin Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 68180-242_5c8549a4-9f30-4c2b-92ca-ee87ef6a9822 68180-242 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA078424 Lupin Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 68180-265_04602ef4-3ca7-4ce5-a27b-28260bca7ab3 68180-265 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078790 Lupin Pharmaceuticals, Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68180-266_04602ef4-3ca7-4ce5-a27b-28260bca7ab3 68180-266 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078790 Lupin Pharmaceuticals, Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68180-267_04602ef4-3ca7-4ce5-a27b-28260bca7ab3 68180-267 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078790 Lupin Pharmaceuticals, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68180-280_8889d78c-1b91-42c6-beb1-e3c94c87d119 68180-280 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET ORAL 20090704 ANDA ANDA078939 LUPIN PHARMACEUTICALS INC ETHAMBUTOL HYDROCHLORIDE 100 mg/1 Antimycobacterial [EPC] 68180-281_8889d78c-1b91-42c6-beb1-e3c94c87d119 68180-281 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET ORAL 20090704 ANDA ANDA078939 LUPIN PHARMACEUTICALS INC ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] 68180-284_a2f0a1a8-97b2-40ce-a2f8-bbcf23376bda 68180-284 HUMAN PRESCRIPTION DRUG LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE AND ZIDOVUDINE TABLET ORAL 20120514 ANDA ANDA090246 Lupin Pharmaceuticals, Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 68180-285_0201d563-7035-481a-ae48-81e71f8a1121 68180-285 HUMAN PRESCRIPTION DRUG rifabutin rifabutin CAPSULE ORAL 20140326 ANDA ANDA090033 Lupin Pharmaceuticals, Inc. RIFABUTIN 150 mg/1 Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient] 68180-286_09e0233d-c9f2-4a62-ae66-0f454cfdae76 68180-286 HUMAN PRESCRIPTION DRUG ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET ORAL 20131217 ANDA ANDA202912 Lupin Pharmaceuticals, Inc. ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE 300; 150; 300 mg/1; mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 68180-294_cfe4a206-b8fb-4b40-a98e-42d8d022f19b 68180-294 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090694 Lupin Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68180-295_cfe4a206-b8fb-4b40-a98e-42d8d022f19b 68180-295 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090694 Lupin Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68180-296_cfe4a206-b8fb-4b40-a98e-42d8d022f19b 68180-296 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090694 Lupin Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68180-302_ecc77275-d3b4-4c85-9bad-7a864aa44c62 68180-302 HUMAN PRESCRIPTION DRUG cefuroxime axetil cefuroxime axetil TABLET ORAL 20030725 ANDA ANDA065135 Lupin Pharmaceuticals, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-303_ecc77275-d3b4-4c85-9bad-7a864aa44c62 68180-303 HUMAN PRESCRIPTION DRUG cefuroxime axetil cefuroxime axetil TABLET ORAL 20030725 ANDA ANDA065135 Lupin Pharmaceuticals, Inc. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-311_0311736f-fb5a-4b3c-b978-31063bdc7fed 68180-311 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20101221 ANDA ANDA090443 Lupin Pharmaceuticals, Inc. IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 68180-312_0311736f-fb5a-4b3c-b978-31063bdc7fed 68180-312 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20101221 ANDA ANDA090442 Lupin Pharmaceuticals, Inc. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 68180-313_0311736f-fb5a-4b3c-b978-31063bdc7fed 68180-313 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20101221 ANDA ANDA090441 Lupin Pharmaceuticals, Inc. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 68180-314_e6d2183f-7136-455a-b20e-066588bae078 68180-314 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100416 ANDA ANDA090444 Lupin Pharmaceuticals, Inc. IMIPRAMINE PAMOATE 75 mg/1 Tricyclic Antidepressant [EPC] 68180-315_e6d2183f-7136-455a-b20e-066588bae078 68180-315 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100416 ANDA ANDA090444 Lupin Pharmaceuticals, Inc. IMIPRAMINE PAMOATE 100 mg/1 Tricyclic Antidepressant [EPC] 68180-316_e6d2183f-7136-455a-b20e-066588bae078 68180-316 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100416 ANDA ANDA090444 Lupin Pharmaceuticals, Inc. IMIPRAMINE PAMOATE 125 mg/1 Tricyclic Antidepressant [EPC] 68180-317_e6d2183f-7136-455a-b20e-066588bae078 68180-317 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100416 ANDA ANDA090444 Lupin Pharmaceuticals, Inc. IMIPRAMINE PAMOATE 150 mg/1 Tricyclic Antidepressant [EPC] 68180-322_56783507-49a7-4ea7-bfa8-3015f04618f2 68180-322 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091124 Lupin Pharmaceuticals, Inc. ESZOPICLONE 1 mg/1 CIV 68180-323_56783507-49a7-4ea7-bfa8-3015f04618f2 68180-323 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091124 Lupin Pharmaceuticals, Inc. ESZOPICLONE 2 mg/1 CIV 68180-324_56783507-49a7-4ea7-bfa8-3015f04618f2 68180-324 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091124 Lupin Pharmaceuticals, Inc. ESZOPICLONE 3 mg/1 CIV 68180-331_7a6f060e-cbd8-4988-b84e-45891530ebfb 68180-331 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Lupin Pharmaceuticals, Inc. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] 68180-332_7a6f060e-cbd8-4988-b84e-45891530ebfb 68180-332 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Lupin Pharmaceuticals, Inc. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] 68180-333_7a6f060e-cbd8-4988-b84e-45891530ebfb 68180-333 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Lupin Pharmaceuticals, Inc. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] 68180-334_7a6f060e-cbd8-4988-b84e-45891530ebfb 68180-334 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Lupin Pharmaceuticals, Inc. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] 68180-336_6c1df27f-97e2-47ab-b435-ba56d17a764c 68180-336 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110930 ANDA ANDA090692 LUPIN PHARMACEUTICALS INC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68180-337_6c1df27f-97e2-47ab-b435-ba56d17a764c 68180-337 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110930 ANDA ANDA090692 LUPIN PHARMACEUTICALS INC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68180-351_45f14e51-0132-4275-886e-9a82ba550176 68180-351 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Lupin Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68180-352_45f14e51-0132-4275-886e-9a82ba550176 68180-352 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Lupin Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68180-353_45f14e51-0132-4275-886e-9a82ba550176 68180-353 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Lupin Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68180-360_7adf819f-e6a3-4595-932d-db6c6fd6bca6 68180-360 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20120713 ANDA ANDA090856 Lupin Pharmaceuticals, Inc. FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68180-361_7adf819f-e6a3-4595-932d-db6c6fd6bca6 68180-361 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20120713 ANDA ANDA090856 Lupin Pharmaceuticals, Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68180-379_f94e4f6f-c579-4854-b8dc-fbafda0bae0a 68180-379 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120214 ANDA ANDA091424 Lupin Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 45 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 68180-380_f94e4f6f-c579-4854-b8dc-fbafda0bae0a 68180-380 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120214 ANDA ANDA091424 Lupin Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 90 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 68180-381_f94e4f6f-c579-4854-b8dc-fbafda0bae0a 68180-381 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120214 ANDA ANDA091424 Lupin Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 135 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 68180-383_c2e898d7-d94c-4d73-9609-769e3c08a4b3 68180-383 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110926 20160531 ANDA ANDA200503 Lupin Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 68180-384_c2e898d7-d94c-4d73-9609-769e3c08a4b3 68180-384 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110926 20151130 ANDA ANDA200503 Lupin Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 68180-385_c2e898d7-d94c-4d73-9609-769e3c08a4b3 68180-385 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110926 20151231 ANDA ANDA200503 Lupin Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 68180-392_dda7c7ba-98ac-4dde-b09f-78fb29671573 68180-392 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN KIT 20140606 ANDA ANDA200563 Lupin Pharmaceuticals, Inc. 68180-393_dda7c7ba-98ac-4dde-b09f-78fb29671573 68180-393 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN KIT 20140606 ANDA ANDA200563 Lupin Pharmaceuticals, Inc. 68180-401_387fa023-64aa-415e-8580-32c80c80a4ec 68180-401 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL POWDER, FOR SUSPENSION ORAL 20051201 ANDA ANDA065261 LUPIN PHARMACEUTICALS INC CEFPROZIL 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-402_387fa023-64aa-415e-8580-32c80c80a4ec 68180-402 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL POWDER, FOR SUSPENSION ORAL 20051201 ANDA ANDA065261 LUPIN PHARMACEUTICALS INC CEFPROZIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-403_7c093997-9476-4a50-b95a-c9fdadf7b47b 68180-403 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET ORAL 20051201 ANDA ANDA065276 Lupin Pharmaceuticals, Inc. CEFPROZIL 250 mg/1 68180-404_7c093997-9476-4a50-b95a-c9fdadf7b47b 68180-404 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET ORAL 20051201 ANDA ANDA065276 Lupin Pharmaceuticals, Inc. CEFPROZIL 500 mg/1 68180-410_dcb10589-8d7a-4bdc-8575-77d85afb4c34 68180-410 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20121023 ANDA ANDA201531 Lupin Pharmaceuticals, Inc. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-411_dcb10589-8d7a-4bdc-8575-77d85afb4c34 68180-411 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20121023 ANDA ANDA201531 Lupin Pharmaceuticals, Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-412_dcb10589-8d7a-4bdc-8575-77d85afb4c34 68180-412 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20121023 ANDA ANDA201531 Lupin Pharmaceuticals, Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-413_37b2771b-1688-4b6d-80f4-7e7fd95cec24 68180-413 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130404 ANDA ANDA201524 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-414_37b2771b-1688-4b6d-80f4-7e7fd95cec24 68180-414 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130404 ANDA ANDA201524 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68180-429_cf1451db-6969-4b77-92e2-6bc9f20831ad 68180-429 HUMAN PRESCRIPTION DRUG bimatoprost bimatoprost SOLUTION/ DROPS OPHTHALMIC 20140819 ANDA ANDA203991 Lupin Pharmaceuticals, Inc. BIMATOPROST .3 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 68180-435_0d564756-cbfc-4e90-bd47-8e44d1cc6566 68180-435 HUMAN PRESCRIPTION DRUG Gatifloxacin Gatifloxacin SOLUTION/ DROPS OPHTHALMIC 20131001 ANDA ANDA202653 Lupin Pharmaceuticals, Inc. GATIFLOXACIN 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68180-445_0c522089-ea07-40aa-8644-f6b9ebcca345 68180-445 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] 68180-446_0c522089-ea07-40aa-8644-f6b9ebcca345 68180-446 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] 68180-447_0c522089-ea07-40aa-8644-f6b9ebcca345 68180-447 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] 68180-448_0c522089-ea07-40aa-8644-f6b9ebcca345 68180-448 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 68180-449_0c522089-ea07-40aa-8644-f6b9ebcca345 68180-449 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 68180-450_0c522089-ea07-40aa-8644-f6b9ebcca345 68180-450 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] 68180-467_693a7e34-1f19-43d5-8f39-ff2ebfd8a547 68180-467 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Lupin Pharmaceuticals, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68180-468_693a7e34-1f19-43d5-8f39-ff2ebfd8a547 68180-468 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Lupin Pharmaceuticals, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68180-469_693a7e34-1f19-43d5-8f39-ff2ebfd8a547 68180-469 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Lupin Pharmaceuticals, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68180-478_415a6c35-f3cb-45c2-9ce8-c64ce4f6d66a 68180-478 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070612 ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68180-479_415a6c35-f3cb-45c2-9ce8-c64ce4f6d66a 68180-479 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070614 ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68180-480_415a6c35-f3cb-45c2-9ce8-c64ce4f6d66a 68180-480 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070612 ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68180-481_415a6c35-f3cb-45c2-9ce8-c64ce4f6d66a 68180-481 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070612 ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68180-482_415a6c35-f3cb-45c2-9ce8-c64ce4f6d66a 68180-482 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20090714 ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68180-485_0cf6dde2-7c42-46d5-8c82-eba443440f61 68180-485 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20080724 ANDA ANDA077917 Lupin Pharmaceuticals, Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68180-486_0cf6dde2-7c42-46d5-8c82-eba443440f61 68180-486 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20080724 ANDA ANDA077917 Lupin Pharmaceuticals, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68180-487_0cf6dde2-7c42-46d5-8c82-eba443440f61 68180-487 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20080724 ANDA ANDA077917 Lupin Pharmaceuticals, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68180-488_0cf6dde2-7c42-46d5-8c82-eba443440f61 68180-488 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20080724 ANDA ANDA077917 Lupin Pharmaceuticals, Inc. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68180-501_122e633a-7350-4abe-a7f3-19ff8896fc2b 68180-501 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060719 ANDA ANDA077944 Lupin Pharmaceuticals, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68180-502_122e633a-7350-4abe-a7f3-19ff8896fc2b 68180-502 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060719 ANDA ANDA077944 Lupin Pharmaceuticals, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68180-512_b1888bc5-5e29-4d4d-9ac2-6828aa24f920 68180-512 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Lupin Pharmaceuticals, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-513_b1888bc5-5e29-4d4d-9ac2-6828aa24f920 68180-513 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Lupin Pharmaceuticals, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-514_b1888bc5-5e29-4d4d-9ac2-6828aa24f920 68180-514 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Lupin Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-515_b1888bc5-5e29-4d4d-9ac2-6828aa24f920 68180-515 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Lupin Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-516_b1888bc5-5e29-4d4d-9ac2-6828aa24f920 68180-516 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Lupin Pharmaceuticals, Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-517_b1888bc5-5e29-4d4d-9ac2-6828aa24f920 68180-517 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Lupin Pharmaceuticals, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-518_50197ed7-fd07-45d4-90a8-acb2b3763958 68180-518 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20061004 ANDA ANDA077912 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-519_50197ed7-fd07-45d4-90a8-acb2b3763958 68180-519 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060410 ANDA ANDA077912 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-520_50197ed7-fd07-45d4-90a8-acb2b3763958 68180-520 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060410 ANDA ANDA077912 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-554_9fbe231a-b73e-4430-a8ca-a72ec7c33174 68180-554 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20140801 ANDA ANDA077690 Lupin Pharmaceuticals, Inc. QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-556_9fbe231a-b73e-4430-a8ca-a72ec7c33174 68180-556 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20070226 ANDA ANDA077690 Lupin Pharmaceuticals, Inc. QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-557_9fbe231a-b73e-4430-a8ca-a72ec7c33174 68180-557 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20070226 ANDA ANDA077690 Lupin Pharmaceuticals, Inc. QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-558_9fbe231a-b73e-4430-a8ca-a72ec7c33174 68180-558 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20070226 ANDA ANDA077690 Lupin Pharmaceuticals, Inc. QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-559_9fbe231a-b73e-4430-a8ca-a72ec7c33174 68180-559 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20070226 20160430 ANDA ANDA077690 Lupin Pharmaceuticals, Inc. QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-566_8bd72025-ac84-42d0-8657-ba2fab7972bd 68180-566 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070611 ANDA ANDA077522 Lupin Pharmaceuticals, Inc. TRANDOLAPRIL 1 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-567_8bd72025-ac84-42d0-8657-ba2fab7972bd 68180-567 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070611 ANDA ANDA077522 Lupin Pharmaceuticals, Inc. TRANDOLAPRIL 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-568_8bd72025-ac84-42d0-8657-ba2fab7972bd 68180-568 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070611 ANDA ANDA077522 Lupin Pharmaceuticals, Inc. TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-588_f9240463-b38b-4dc3-8954-a216a85cafa1 68180-588 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080610 ANDA ANDA077626 Lupin Pharmaceuticals, Inc. RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-589_f9240463-b38b-4dc3-8954-a216a85cafa1 68180-589 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080610 ANDA ANDA077626 Lupin Pharmaceuticals, Inc. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-590_f9240463-b38b-4dc3-8954-a216a85cafa1 68180-590 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080610 ANDA ANDA077626 Lupin Pharmaceuticals, Inc. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-591_f9240463-b38b-4dc3-8954-a216a85cafa1 68180-591 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080610 ANDA ANDA077626 Lupin Pharmaceuticals, Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68180-596_facdf14c-e388-4b91-8893-ea46a0cbe284 68180-596 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Lupin Pharmaceuticals, Inc. CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68180-597_facdf14c-e388-4b91-8893-ea46a0cbe284 68180-597 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Lupin Pharmaceuticals, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68180-598_facdf14c-e388-4b91-8893-ea46a0cbe284 68180-598 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Lupin Pharmaceuticals, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68180-599_facdf14c-e388-4b91-8893-ea46a0cbe284 68180-599 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Lupin Pharmaceuticals, Inc. CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68180-611_2a960b86-5051-4b85-8d65-9b094e3b06bb 68180-611 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090601 ANDA ANDA065125 Lupin Pharmaceuticals, Inc. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-622_2a960b86-5051-4b85-8d65-9b094e3b06bb 68180-622 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090601 ANDA ANDA065125 Lupin Pharmaceuticals, Inc. CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-633_2a960b86-5051-4b85-8d65-9b094e3b06bb 68180-633 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090601 ANDA ANDA065125 Lupin Pharmaceuticals, Inc. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-644_2a960b86-5051-4b85-8d65-9b094e3b06bb 68180-644 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090601 ANDA ANDA065125 Lupin Pharmaceuticals, Inc. CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-650_d1e72e66-753f-471a-98ef-05bba404a760 68180-650 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE CAPSULE ORAL 20140414 ANDA ANDA204234 Lupin Pharmaceuticals, Inc. DOXYCYCLINE 50 mg/1 68180-651_d1e72e66-753f-471a-98ef-05bba404a760 68180-651 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE CAPSULE ORAL 20140414 ANDA ANDA204234 Lupin Pharmaceuticals, Inc. DOXYCYCLINE 75 mg/1 68180-652_d1e72e66-753f-471a-98ef-05bba404a760 68180-652 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE CAPSULE ORAL 20140414 ANDA ANDA204234 Lupin Pharmaceuticals, Inc. DOXYCYCLINE 100 mg/1 68180-655_5148a49e-6008-44e7-8bb0-1adec8aecf69 68180-655 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060912 ANDA ANDA065263 Lupin Pharmaceuticals, Inc. CEFTRIAXONE SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-657_32e0a0e6-1494-45a6-a2b8-cd9da25b6164 68180-657 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE FOR SUSPENSION ORAL 20130604 ANDA ANDA201678 Lupin Pharmaceuticals, Inc. DOXYCYCLINE 25 mg/5mL 68180-658_3290688d-ad1f-4579-abfe-2ad2da71f75f 68180-658 HUMAN PRESCRIPTION DRUG rifampin rifampin CAPSULE ORAL 20131028 ANDA ANDA090034 Lupin Pharmaceuticals, Inc. RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 68180-659_3290688d-ad1f-4579-abfe-2ad2da71f75f 68180-659 HUMAN PRESCRIPTION DRUG rifampin rifampin CAPSULE ORAL 20131028 ANDA ANDA090034 Lupin Pharmaceuticals, Inc. RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 68180-697_963a483a-c4e3-486c-9d22-95d581fe5521 68180-697 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20140818 ANDA ANDA200503 Lupin Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68180-698_963a483a-c4e3-486c-9d22-95d581fe5521 68180-698 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20140818 ANDA ANDA200503 Lupin Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68180-699_963a483a-c4e3-486c-9d22-95d581fe5521 68180-699 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20140818 ANDA ANDA200503 Lupin Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68180-711_d8b98e55-6a09-4670-9826-ad0a191b1baa 68180-711 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20070501 ANDA ANDA065264 LUPIN PHARMACEUTICALS INC CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-722_6e3c7876-4ca7-4219-a6c4-5a668dc2c862 68180-722 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070501 ANDA ANDA065259 LUPIN PHARMACEUTICALS INC CEFDINIR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-723_6e3c7876-4ca7-4219-a6c4-5a668dc2c862 68180-723 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070501 ANDA ANDA065259 LUPIN PHARMACEUTICALS INC CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68180-750_05543906-58a3-4337-9101-0c32519925a1 68180-750 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070803 ANDA ANDA078043 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68180-751_05543906-58a3-4337-9101-0c32519925a1 68180-751 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070803 ANDA ANDA078043 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68180-752_05543906-58a3-4337-9101-0c32519925a1 68180-752 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070803 ANDA ANDA078043 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68180-755_43c2eabf-1637-423e-a532-02ee23f972c8 68180-755 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100205 ANDA ANDA078466 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68180-756_43c2eabf-1637-423e-a532-02ee23f972c8 68180-756 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100205 ANDA ANDA078466 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68180-757_43c2eabf-1637-423e-a532-02ee23f972c8 68180-757 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100205 ANDA ANDA078466 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68180-758_43c2eabf-1637-423e-a532-02ee23f972c8 68180-758 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100205 ANDA ANDA078466 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68180-759_43c2eabf-1637-423e-a532-02ee23f972c8 68180-759 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA078466 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68180-760_43c2eabf-1637-423e-a532-02ee23f972c8 68180-760 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA078466 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68180-779_6f7ab3b0-4859-4bc3-ac52-0ede40d0408d 68180-779 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE Zolpidem Tartrate TABLET, EXTENDED RELEASE ORAL 20140407 ANDA ANDA078970 Lupin Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] 68180-780_6f7ab3b0-4859-4bc3-ac52-0ede40d0408d 68180-780 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE Zolpidem Tartrate TABLET, EXTENDED RELEASE ORAL 20140407 ANDA ANDA078970 Lupin Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] 68180-837_94036a51-72bc-4fad-9aaa-d997d3d3880e 68180-837 HUMAN PRESCRIPTION DRUG TRI-LO-MARZIA norgestimate and ethinyl estradiol KIT 20120822 ANDA ANDA200541 Lupin Pharmaceuticals, Inc. 68180-843_4ef52dd8-f875-4767-9ab5-15eee66124e8 68180-843 HUMAN PRESCRIPTION DRUG Levonorgestrel and Ethinyl Estradiol Levonorgestrel and Ethinyl Estradiol KIT 20121024 ANDA ANDA091440 Lupin Pharmaceuticals, Inc. 68180-844_0f148aa5-91e6-4387-b78f-33e7c5ee02c7 68180-844 HUMAN PRESCRIPTION DRUG Kurvelo Levonorgestrel and Ethinyl Estradiol KIT 20121026 ANDA ANDA091408 Lupin Pharmaceuticals, Inc. 68180-846_fdf66569-514e-4447-80d6-1c6f9231ccc9 68180-846 HUMAN PRESCRIPTION DRUG Daysee LEVONORGESTREL AND ETHINYL ESTRADIOL KIT 20130410 ANDA ANDA091467 Lupin Pharmaceuticals, Inc. 68180-848_43a1e121-f1eb-494d-86e3-5d6087fc6c64 68180-848 HUMAN PRESCRIPTION DRUG Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol levonorgestrel and ethinyl estradiol KIT 20111202 ANDA ANDA091674 Lupin Pharmaceuticals, Inc. 68180-853_01daac3e-a0ad-48b1-8899-e8b4a8058c86 68180-853 HUMAN OTC DRUG Fallback Solo levonorgestrel TABLET ORAL 20140722 ANDA ANDA201446 Lupin Pharmaceuticals, Inc. LEVONORGESTREL 1.5 mg/1 68180-854_572ca75b-2690-4d9d-b528-3db59932adb9 68180-854 HUMAN PRESCRIPTION DRUG Levonorgestrel and Ethinyl Estradiol Levonorgestrel and Ethinyl Estradiol KIT 20130320 ANDA ANDA091425 Lupin Pharmaceuticals, Inc. 68180-875_913c8f30-d4fb-473e-94ee-d8ae913c9268 68180-875 HUMAN PRESCRIPTION DRUG Vyfemla norethindrone and ethinyl estradiol KIT 20131223 ANDA ANDA201886 Lupin Pharmaceuticals, Inc. 68180-876_b15d0fbc-d644-4631-ab1d-af96a80959ac 68180-876 HUMAN PRESCRIPTION DRUG NORETHINDRONE NORETHINDRONE TABLET ORAL 20111110 ANDA ANDA091325 Lupin Pharmaceuticals, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 68180-877_ad15141c-cadd-4101-a729-8e1ba2a86905 68180-877 HUMAN PRESCRIPTION DRUG Jencycla norethindrone TABLET ORAL 20130508 ANDA ANDA091323 Lupin Pharmaceuticals, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 68180-882_2adc4516-154f-4d6a-8a86-ee499d61226f 68180-882 HUMAN PRESCRIPTION DRUG ENSKYCE desogestrel and ethinyl estradiol KIT 20130507 ANDA ANDA201887 Lupin Pharmaceuticals, Inc. 68180-886_f1a8f418-9b7f-49f3-85e7-1af0607237bc 68180-886 HUMAN PRESCRIPTION DRUG Nikki drospirenone and ethinyl estradiol KIT 20140730 ANDA ANDA201661 Lupin Pharmaceuticals, Inc. 68180-892_d2750f71-c032-4f0d-862d-bf5bc8320abf 68180-892 HUMAN PRESCRIPTION DRUG PIRMELLA 7/7/7 NORETHINDRONE AND ETHINYL ESTRADIOL KIT 20130515 ANDA ANDA201510 Lupin Pharmaceuticals, Inc. 68180-893_d2750f71-c032-4f0d-862d-bf5bc8320abf 68180-893 HUMAN PRESCRIPTION DRUG PIRMELLA 1/35 NORETHINDRONE AND ETHINYL ESTRADIOL KIT 20130621 ANDA ANDA201512 Lupin Pharmaceuticals, Inc. 68180-897_f704dd21-68d1-4697-b07f-4e07a8a9c29c 68180-897 HUMAN PRESCRIPTION DRUG Norethindrone and Ethinyl Estradiol and Ferrous Fumarate Norethindrone and Ethinyl Estradiol KIT 20111004 NDA AUTHORIZED GENERIC NDA021490 Lupin Pharmaceuticals, Inc. 68180-898_f9cfdf35-7cd0-4984-99e4-0e4a7df91b4e 68180-898 HUMAN PRESCRIPTION DRUG WYMZYA FE norethindrone and ethinyl estradiol, and ferrous fumarate KIT 20121219 NDA AUTHORIZED GENERIC NDA021490 Lupin Pharmaceuticals, Inc. 68180-899_e4a8d988-7070-405e-8972-531ebc7636bb 68180-899 HUMAN PRESCRIPTION DRUG WYMZYA FE norethindrone and ethinyl estradiol, and ferrous fumarate KIT 20121219 NDA AUTHORIZED GENERIC NDA021490 Lupin Pharmaceuticals, Inc. 68180-902_26da46cb-09d4-4d18-a3d4-0c2cb4818725 68180-902 HUMAN PRESCRIPTION DRUG DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE AND ETHINYL ESTRADIOL KIT 20121231 ANDA ANDA201663 Lupin Pharmaceuticals, Inc. 68196-008_80260123-dccb-47da-84d9-60c2b43d3bc3 68196-008 HUMAN OTC DRUG Simply Right Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20120117 ANDA ANDA076779 Sam's West Inc NICOTINE 4 mg/1 68196-019_b7306f51-ece9-411c-a4da-e5cfb136408b 68196-019 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130330 ANDA ANDA202727 SIMPLY RIGHT (Sam's West, Inc.) LANSOPRAZOLE 15 mg/1 68196-029_2c43a498-a4fb-4ed1-b4ae-aecfd334945b 68196-029 HUMAN OTC DRUG members mark nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050930 ANDA ANDA076775 Sam's West Inc NICOTINE 2 mg/1 68196-041_014c4796-722c-4cb4-8b9d-596ac5362733 68196-041 HUMAN OTC DRUG simply right Night Time acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20060830 OTC MONOGRAPH FINAL part341 Sam's West Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 68196-061_c88944cf-d1c1-4a64-a384-e5106bfe4039 68196-061 HUMAN OTC DRUG members mark famotidine Famotidine TABLET ORAL 20060928 ANDA ANDA077351 Sam's West Inc FAMOTIDINE 20 mg/1 68196-102_6b3ea903-4521-4a60-9d5c-fac8a63ae68c 68196-102 HUMAN OTC DRUG SIMPLY RIGHT childrens cetirizine Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Sam's West Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 68196-110_4ee40e37-a0a8-4d89-a305-84f998d041b7 68196-110 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20111030 OTC MONOGRAPH NOT FINAL part334 SIMPLY RIGHT (Sam's West, Inc.) DOCUSATE SODIUM 100 mg/1 68196-115_b846e2f4-1a17-4d14-8cf2-35311246a450 68196-115 HUMAN OTC DRUG simply right nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20120126 ANDA ANDA076775 Sam's West Inc NICOTINE 2 mg/1 68196-117_71fe86cd-c59e-4577-8498-9a5867da2e9d 68196-117 HUMAN OTC DRUG Simply Right Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20140529 ANDA ANDA202319 Sam's West Inc LANSOPRAZOLE 15 mg/1 68196-124_2b5a9df8-5329-491a-8d49-fdfbc7314a41 68196-124 HUMAN OTC DRUG simply right nicotine Nicotine Polacrilex LOZENGE ORAL 20120119 ANDA ANDA090711 Sam's West Inc NICOTINE 2 mg/1 68196-140_243b4126-e3dd-4056-ba8a-1ed691248ee6 68196-140 HUMAN OTC DRUG ANTIBACTERIAL HAND SP WITH LIGHT MOISTURIZERS TRICLOSAN LIQUID TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN .115 L/100L 68196-141_72bb3a24-bca4-4921-92af-cb257bc31a27 68196-141 HUMAN OTC DRUG ANTIBACTERIAL HAND SP WITH LIGHT MOISTURIZERS REFILL TRICLOSAN LIQUID TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN .115 L/100L 68196-142_afaa8535-ca51-4409-87c1-70e2e78e64db 68196-142 HUMAN OTC DRUG ANTIBACTERIAL LIGHT MOISTURIZERS TRICLOSAN LIQUID TOPICAL 20110606 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN .115 L/100L 68196-143_4b587026-1a44-4960-8c27-fdb5415914e9 68196-143 HUMAN OTC DRUG ANTIBACTERIAL LIGHT MOISTURIZERS REFILL TRICLOSAN LIQUID TOPICAL 20110606 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN .115 L/100L 68196-144_34c575c6-c900-4699-8605-7d25b967faae 68196-144 HUMAN OTC DRUG SIMPLY RIGHT BODY CARE ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20121024 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN 1.15 mg/mL 68196-145_394ec837-7cc2-4dd6-a463-6ba1d565c8e0 68196-145 HUMAN OTC DRUG SIMPLY RIGHT BODY CARE ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20121025 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN 1.15 mg/mL 68196-146_a2308485-181b-4423-b3de-e7b8c4e35994 68196-146 HUMAN OTC DRUG SIMPLY RIGHT BODY CARE TRICLOSAN LIQUID TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN 1.15 mg/mL 68196-147_6bd8b2d8-c921-410f-be43-a324b8869355 68196-147 HUMAN OTC DRUG SIMPLY RIGHT BODY CARE TRICLOSAN LIQUID TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN 1.15 mg/mL 68196-149_543742ba-7e3d-4067-bf5e-fbc380e3ec22 68196-149 HUMAN OTC DRUG SIMPLY RIGHT HAND BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131223 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC BENZALKONIUM CHLORIDE 1.5 mg/mL 68196-159_626df06d-dd38-4651-a7ac-fb1aed19e970 68196-159 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin and Caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Sam's West Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 68196-170_8edad777-6491-4ab2-9835-709bf54d5f0c 68196-170 HUMAN OTC DRUG members mark nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20051005 ANDA ANDA076789 Sam's West Inc NICOTINE 4 mg/1 68196-175_90e22583-e04a-47a1-81b5-58cd8e1f36bf 68196-175 HUMAN OTC DRUG Extra Strength Acetaminophen Acetaminophen CAPSULE ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 Sam's West Inc ACETAMINOPHEN 500 mg/1 68196-190_478f6d2d-89c3-492a-9947-bf77258b2f19 68196-190 HUMAN OTC DRUG simply right nicotine Nicotine Polacrilex LOZENGE ORAL 20120116 ANDA ANDA090711 Sam's West Inc NICOTINE 4 mg/1 68196-194_201568f1-6a6d-47b9-b1f3-32a4662dea36 68196-194 HUMAN OTC DRUG Nicotine transdermal system nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20120302 NDA NDA020165 Sam's West Inc NICOTINE 21 mg/24h 68196-201_ef916483-e1f8-475e-b9d4-8d1e45040bde 68196-201 HUMAN OTC DRUG Members Mark Nicotine Nicotine Polacrilex LOZENGE ORAL 20110622 ANDA ANDA090821 Sam's West Inc NICOTINE 2 mg/1 68196-213_95261ac0-1c66-45c4-9cc9-eceddc52f656 68196-213 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130430 OTC MONOGRAPH FINAL part341 SIMPLY RIGHT (Sam's West, Inc.) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 68196-224_7ffcd567-c98f-411d-ac45-5781008367e1 68196-224 HUMAN OTC DRUG simply right anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030429 ANDA ANDA075232 Sam's West Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 68196-236_d30ce5f6-f132-4421-a38b-fba29406631e 68196-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 SIMPLY RIGHT (Sam's West, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 68196-291_62a2f698-6ddb-4139-a019-30ca2658c24f 68196-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 OTC MONOGRAPH NOT FINAL part343 Sam's West Inc IBUPROFEN 200 mg/1 68196-294_783acab1-e4c4-44d7-ab6e-80fe57644678 68196-294 HUMAN OTC DRUG simply right minoxidil Minoxidil AEROSOL, FOAM TOPICAL 20120301 ANDA ANDA091344 Sam's West Inc MINOXIDIL 5 g/100g 68196-299_ae1239d5-5014-47f0-b8aa-ee18e780a4df 68196-299 HUMAN OTC DRUG simply right famotidine Famotidine TABLET ORAL 20120126 ANDA ANDA077351 Sam's West Inc FAMOTIDINE 20 mg/1 68196-300_b69f1052-e83d-468e-909a-6f84cc969dd1 68196-300 HUMAN OTC DRUG Simply Right Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20120121 ANDA ANDA076789 Sam's West Inc NICOTINE 4 mg/1 68196-306_5bc34a90-adc2-4031-b8a6-725829881550 68196-306 HUMAN OTC DRUG Members Mark clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091008 ANDA ANDA090685 Sam's West Inc POLYETHYLENE GLYCOL 3350 17 g/17g 68196-321_b329e721-a22a-417b-a642-6c371cbea558 68196-321 HUMAN OTC DRUG simply right famotidine complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20120310 ANDA ANDA077355 Sam's West Inc CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 68196-324_55dfe27c-ed47-4e30-9f1e-4a50af5f94b5 68196-324 HUMAN OTC DRUG SIMPLY RIGHT BODY CARE DAILY MOISTURIZING DIMETHICONE LOTION TOPICAL 20130206 OTC MONOGRAPH FINAL part347 SAM'S WEST INC. DIMETHICONE 13 mg/mL 68196-324_571d8f2d-71d0-4c6f-acf2-7ce46a4160d6 68196-324 HUMAN OTC DRUG SIMPLY RIGHT BODY CARE DAILY MOISTURIZING DIMETHICONE LOTION TOPICAL 20130206 OTC MONOGRAPH FINAL part347 SAM'S WEST INC. DIMETHICONE 13 mg/mL 68196-329_455f4cc9-fb18-4523-9a82-7e799665e4ed 68196-329 HUMAN OTC DRUG diphenhydramine Diphenhydramine HCl CAPSULE, COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 Sam's West Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 68196-344_b5c67899-3c5c-4dc4-9968-5dce343e0532 68196-344 HUMAN OTC DRUG simply right nicotine Nicotine Polacrilex LOZENGE ORAL 20070907 ANDA ANDA077007 Sam's West Inc NICOTINE 2 mg/1 68196-368_1f256c29-bf6a-4b87-ae93-1ae5bed18bbb 68196-368 HUMAN OTC DRUG members mark naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20070529 ANDA ANDA074661 Sam's West Inc NAPROXEN SODIUM 220 mg/1 68196-375_f43b3f3d-731f-4011-87f2-5c1e4f3e648a 68196-375 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 Sam's West Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 68196-411_9f40d59a-9950-43fa-ae2a-d934f585ddc0 68196-411 HUMAN OTC DRUG Simply Right clearLAX Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20120119 ANDA ANDA090685 Sam's West Inc POLYETHYLENE GLYCOL 3350 17 g/17g 68196-432_14ef1e9a-8a9a-4e5b-8087-5c18f635afe4 68196-432 HUMAN OTC DRUG members mark nasal decongestant maximum strength Pseudoephedrine HCl TABLET, FILM COATED ORAL 19990203 OTC MONOGRAPH FINAL part341 Sam's West Inc PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 68196-455_9e6aa681-a249-4b4b-8532-d1f777e9cd81 68196-455 HUMAN OTC DRUG Allergy Multi-Symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl CAPSULE ORAL 20050626 OTC MONOGRAPH FINAL part341 Sam's West Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 68196-456_f211820b-9bb3-4cce-bbbf-562ba5f279ca 68196-456 HUMAN OTC DRUG simply right nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20120126 ANDA ANDA076777 Sam's West Inc NICOTINE 2 mg/1 68196-458_49a8eea6-80a0-4d42-ac10-45d5bd4bc552 68196-458 HUMAN OTC DRUG Members mark cetirizine Cetirizine Hydrochloride TABLET ORAL 20080324 ANDA ANDA078336 Sam's West Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 68196-463_e3081d30-a476-460e-88a2-1a466ebfceaa 68196-463 HUMAN OTC DRUG simply right arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120128 ANDA ANDA075077 Sam's West Inc ACETAMINOPHEN 650 mg/1 68196-476_740ff017-61d2-41ce-8f0d-70c8376c548c 68196-476 HUMAN OTC DRUG Members Mark Allergy Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20060815 OTC MONOGRAPH FINAL part341 Sam's West Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 68196-479_fbbf5138-53e6-46ff-a208-a8780ddd8116 68196-479 HUMAN OTC DRUG simply right diphenhydramine hydrochloride allergy relief Diphenhydramine Hydrochloride TABLET ORAL 20120127 OTC MONOGRAPH FINAL part341 Sam's West Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 68196-484_7e8e3b9d-14a2-401e-9a5c-7443d169261b 68196-484 HUMAN OTC DRUG Members Mark Acetaminophen Acetaminophen TABLET ORAL 20100208 OTC MONOGRAPH NOT FINAL part343 Sam's West Inc ACETAMINOPHEN 500 mg/1 68196-498_0c0ad682-a542-45d2-b98d-2c252107d55a 68196-498 HUMAN OTC DRUG Simply Right Mucus Relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130820 ANDA ANDA078912 Sam's West Inc GUAIFENESIN 600 mg/1 68196-499_61a2256b-e085-4b6a-a1a8-43e05a3d2b95 68196-499 HUMAN OTC DRUG simply right naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20140212 ANDA ANDA074661 Sam's West Inc NAPROXEN SODIUM 220 mg/1 68196-519_6b792d0d-e0c3-42d3-af9b-ca6ed080e304 68196-519 HUMAN OTC DRUG Extra Strength Acetaminophen Acetaminophen CAPSULE, GELATIN COATED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Sam's West Inc ACETAMINOPHEN 500 mg/1 68196-532_5ffce1f0-f84a-4367-b20f-05fedd1e6a62 68196-532 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20051222 OTC MONOGRAPH FINAL part341 Sam's West Inc GUAIFENESIN 400 mg/1 68196-541_85cdaf2c-8003-4931-9b20-9aa6038b5d25 68196-541 HUMAN OTC DRUG members mark hydrocortisone Hydrocortisone CREAM TOPICAL 20070713 OTC MONOGRAPH NOT FINAL part348 Sam's West Inc HYDROCORTISONE 1 g/100g 68196-544_1c225a56-0725-4b22-b9df-13a60212d6e2 68196-544 HUMAN OTC DRUG members mark arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050831 ANDA ANDA075077 Sam's West Inc ACETAMINOPHEN 650 mg/1 68196-553_30f1f9a5-e347-4baa-8643-5c29ad752424 68196-553 HUMAN OTC DRUG simply right acetaminophen Acetaminophen TABLET ORAL 20140213 OTC MONOGRAPH NOT FINAL part343 Sam's West Inc ACETAMINOPHEN 500 mg/1 68196-571_01ee0f64-8ea5-4727-a681-380e240cc844 68196-571 HUMAN OTC DRUG members mark fexofenadine fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Sam's West Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 68196-600_d1fbaa63-07ad-446d-8ccb-f19d278d84bd 68196-600 HUMAN OTC DRUG Low Dose Adult Aspirin Aspirin TABLET ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 Sam's West Inc ASPIRIN 81 mg/1 68196-604_5d16dcf4-d51f-4ce4-98ef-b7ead987f7be 68196-604 HUMAN OTC DRUG simply right ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20111218 ANDA ANDA072096 Sam's West Inc IBUPROFEN 200 mg/1 68196-612_062c5b19-17a4-4e48-97f6-c2af7d62dc87 68196-612 HUMAN OTC DRUG Members Mark Loratadine Loratadine TABLET ORAL 20070521 ANDA ANDA076301 Sam's West Inc LORATADINE 10 mg/1 68196-690_af2bd762-ca4b-436e-9aa4-95fd9cfcdaa4 68196-690 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20111030 OTC MONOGRAPH FINAL part336 SIMPLY RIGHT (Sam's West, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 68196-702_05fb437b-3771-4814-ae07-6068b009680b 68196-702 HUMAN OTC DRUG simply right cetirizine hydrochloride Cetirizine Hydrochloride TABLET ORAL 20130410 ANDA ANDA078336 Sam's West Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 68196-733_8a6393c7-0b5c-4f76-b24a-9cbc0730bd5a 68196-733 HUMAN OTC DRUG Simply Right Loratadine Loratadine TABLET ORAL 20140103 ANDA ANDA076301 Sam's West Inc LORATADINE 10 mg/1 68196-742_0f6b9ff1-4105-439f-988c-b525644d4cb6 68196-742 HUMAN OTC DRUG simply right naproxen sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20110609 NDA NDA021920 Sam's West Inc NAPROXEN SODIUM 220 mg/1 68196-798_73858a95-4f3f-4b1c-bbd6-2995c79bdca3 68196-798 HUMAN OTC DRUG simply right minoxidil extra strength Minoxidil SOLUTION TOPICAL 20110630 ANDA ANDA075598 Sam's West Inc MINOXIDIL 3 g/60mL 68196-800_a9e8a216-b455-4218-a3d1-bcd89a89a00c 68196-800 HUMAN OTC DRUG Simply Right Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20111228 NDA NDA022032 Sam's West Inc OMEPRAZOLE 20 mg/1 68196-803_791b95e2-c264-425c-9f39-69cf48b8602e 68196-803 HUMAN OTC DRUG SIMPLY RIGHT ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20121015 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN 1.5 mg/mL 68196-804_b50cf0e6-999f-473a-8e4c-4b7842b1dda6 68196-804 HUMAN OTC DRUG ANTIBACTERIAL SPARKLING MIST TRICLOSAN SOLUTION TOPICAL 20110617 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC TRICLOSAN .15 mL/100mL 68196-808_aea2d91d-9cf8-435a-b4b2-35b0389165aa 68196-808 HUMAN OTC DRUG SIMPLY RIGHT SPARKLING MIST TRICLOSAN LIQUID TOPICAL 20130812 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC TRICLOSAN 1.5 mg/mL 68196-809_f1c33970-1c3f-4b87-b743-c943535a4ae0 68196-809 HUMAN OTC DRUG SIMPLY RIGHT BODY CARE SPARKLING MIST TRICLOSAN LIQUID TOPICAL 20130812 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN 1.5 mg/mL 68196-872_059bde44-3210-4e23-8989-6348ef243a6c 68196-872 HUMAN OTC DRUG simply right night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120830 OTC MONOGRAPH FINAL part341 Sam's West Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 68196-873_36c15917-eceb-4f5a-9021-711956e7b51b 68196-873 HUMAN OTC DRUG Members Mark Nicotine Nicotine Polacrilex LOZENGE ORAL 20070907 ANDA ANDA077007 Sam's West Inc NICOTINE 4 mg/1 68196-915_0edfa800-fb14-44dd-9c31-de930b864ef9 68196-915 HUMAN OTC DRUG members mark omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080225 NDA NDA022032 Sam's West Inc OMEPRAZOLE 20 mg/1 68196-930_61ade249-dd2e-4fc4-b182-6f16f2b5f8fa 68196-930 HUMAN OTC DRUG Simply Right Nicotine Nicotine Polacrilex LOZENGE ORAL 20140505 ANDA ANDA077007 Sam's West Inc NICOTINE 4 mg/1 68196-974_927cde6a-f006-42f3-a64f-75d99e7de2be 68196-974 HUMAN OTC DRUG Simply Right Childrens Cetirizine cetirizine hydrochloride LIQUID ORAL 20120126 ANDA ANDA090254 Sam's West Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL 68209-843_0e0a702d-888c-e29e-e8bf-9910b8719d1c 68209-843 PLASMA DERIVATIVE Octagam Immune Globulin (Human) Immune Globulin SOLUTION INTRAVENOUS 20060414 BLA BLA125062 Octapharma AB HUMAN IMMUNOGLOBULIN G 50 mg/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 68210-0001_bc82778e-46c6-4bc3-86f8-c6209faeb8bf 68210-0001 HUMAN OTC DRUG Y LAX DR BISACODYL TABLET, SUGAR COATED ORAL 20100501 OTC MONOGRAPH NOT FINAL part334 SPIRIT PHARMACEUTICALS,LLC BISACODYL 5 mg/1 68210-0002_5d1f922b-62f7-41e7-849d-6bc036138e59 68210-0002 HUMAN OTC DRUG P LAX DR BISACODYL TABLET, SUGAR COATED ORAL 20100501 OTC MONOGRAPH NOT FINAL part334 SPIRIT PHARMACEUTICALS,LLC BISACODYL 5 mg/1 68210-0005_acf830c4-b8b4-4a16-906f-fb3c4f70e7bf 68210-0005 HUMAN OTC DRUG DEXTROMETHORPHAN Hydrobromide DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20141201 OTC MONOGRAPH FINAL part341 Spirit Pharmaceuticals LLC DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 68210-0007_0935b09d-5609-4cc5-a65c-e5da29bc9449 68210-0007 HUMAN OTC DRUG FAMOTIDINE FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130819 ANDA ANDA077146 SPIRIT PHARMACEUTICALS,LLC FAMOTIDINE 10 mg/1 68210-0009_cecc2aed-bb1c-48ec-b1b8-dd6456c9fc2c 68210-0009 HUMAN OTC DRUG IBUPROFEN IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20120501 ANDA ANDA079205 SPIRIT PHARMACEUTICALS,LLC IBUPROFEN 220 mg/1 68210-0101_896b3914-8b53-4fcd-94d9-e84daf967cfe 68210-0101 HUMAN OTC DRUG ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20091015 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 68210-0102_07411e45-3c8d-4353-a9c4-3c14c0e29e67 68210-0102 HUMAN OTC DRUG ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20091015 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 68210-0400_0461de93-404c-41ab-83ab-e59fd0cb96dd 68210-0400 HUMAN OTC DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110801 ANDA ANDA090545 SPIRIT PHARMACEUTICALS,LLC NAPROXEN SODIUM 220 mg/1 68210-0401_09ea20a4-6502-4c60-bca9-86b493b5b1e3 68210-0401 HUMAN OTC DRUG DOCUSATE SODIUM DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100301 OTC MONOGRAPH NOT FINAL part334 SPIRIT PHARMACEUTICALS,LLC DOCUSATE SODIUM 100 mg/1 68210-0402_5a59a01e-65e5-484d-8d4e-a25bef6dc4ab 68210-0402 HUMAN OTC DRUG DOCUSATE SODIUM DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20091001 OTC MONOGRAPH FINAL part310.545 SPIRIT PHARMACEUTICALS,LLC DOCUSATE SODIUM 50 mg/1 68210-1470_a9df99cc-ede3-4b7b-831d-f187e8f4794f 68210-1470 HUMAN OTC DRUG D TIME SINUS ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100301 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS,LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 68210-1480_f717106a-0bf5-4df3-adb1-0d54e406e2a3 68210-1480 HUMAN OTC DRUG N - TIME SINUS ACETAMINOPHEN, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE Hydrochloride CAPSULE, LIQUID FILLED ORAL 20100301 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS,LLC ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 68210-1490_2b51f558-dafe-4807-8bd9-d5753a427bc7 68210-1490 HUMAN OTC DRUG D - TIME ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20100530 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS,LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 68210-1500_fb2cad6f-707b-4e89-80f9-9c155bc7bff6 68210-1500 HUMAN OTC DRUG N - TIME ACETAMINOPHEN, DOXYLAMINE SUCCINATE, and DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20100530 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS,LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 68210-1510_76d8de20-70b3-4727-9dea-d31d1b1e970d 68210-1510 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100601 OTC MONOGRAPH FINAL part338 SPIRIT PHARMACEUTICALS,LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 68210-1520_0fe4df43-f430-4cf1-9033-43387e7db002 68210-1520 HUMAN OTC DRUG FERROUS SULFATE FERROUS SULFATE, DRIED TABLET, FILM COATED ORAL 20101215 UNAPPROVED DRUG OTHER SPIRIT PHARMACEUTICALS,LLC FERROUS SULFATE, DRIED 325 mg/1 68210-1520_a71178c0-3156-4c4e-a189-357939a27e27 68210-1520 HUMAN OTC DRUG FERROUS SULFATE FERROUS SULFATE, DRIED TABLET, FILM COATED ORAL 20101215 UNAPPROVED DRUG OTHER SPIRIT PHARMACEUTICALS,LLC FERROUS SULFATE, DRIED 325 mg/1 68210-1530_9e5110a5-04b0-4442-b095-d45e04c2266a 68210-1530 HUMAN OTC DRUG DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20100715 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS,LLC DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 68210-1901_76774f7e-63c1-4ce3-8e70-07bb9408b59a 68210-1901 HUMAN OTC DRUG SIMETHICONE DIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100301 OTC MONOGRAPH FINAL part332 SPIRIT PHARMACEUTICALS,LLC DIMETHICONE 125 mg/1 68210-1902_ff5ca266-7b84-4f5c-8618-3b08556b964e 68210-1902 HUMAN OTC DRUG SIMETHICONE DIMETHICONE CAPSULE, LIQUID FILLED ORAL 20091001 OTC MONOGRAPH FINAL part310.545 SPIRIT PHARMACEUTICALS,LLC DIMETHICONE 180 mg/1 68220-022_2d0c0036-793a-499a-ae56-5d7dcdb62ef2 68220-022 HUMAN PRESCRIPTION DRUG sF Rowasa Mesalamine SUSPENSION RECTAL 20090901 NDA NDA019618 Alaven Pharmaceutical LLC MESALAMINE 4 g/60mL Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 68220-055_251eb269-e7ae-11e1-aff1-0800200c9a66 68220-055 HUMAN PRESCRIPTION DRUG Anadrol-50 oxymetholone TABLET ORAL 19720601 NDA NDA016848 Alaven Pharmaceutical OXYMETHOLONE 50 mg/1 CIII 68220-066_d17d9288-bdc7-4280-b804-5d544c9b3855 68220-066 HUMAN PRESCRIPTION DRUG Rowasa mesalamine ENEMA RECTAL 19880131 NDA NDA019618 Alaven Pharmaceutical LLC MESALAMINE 4 g/60mL Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 68220-083_083a5779-4727-430f-ae00-674122bbdf51 68220-083 HUMAN PRESCRIPTION DRUG PreferaOB plus DHA FOLIC ACID, Heme Iron Polypeptide, IRON DEXTRAN, Potassium Iodide, Zinc Oxide, Selenium, CUPRIC SULFATE, CHOLECALCIFEROL, THIAMINE MONONITRATE, ALPHA-TOCOPHEROL SUCCINATE, D-, RIBOFLAVIN, NIACINAMIDE, TABLET ORAL 20101115 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC ALPHA-TOCOPHEROL SUCCINATE, D-; BIOTIN; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENIUM; THIAMINE MONONITRATE; ZINC OXIDE 10; 30; 10; 400; .8; 12; 1; 6; 28; 17; 250; 50; 1.6; 65; 1.5; 4.5 [iU]/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1 Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 68220-084_aa72cc66-8257-4185-b563-894032636337 68220-084 HUMAN PRESCRIPTION DRUG PreferaOB FOLIC ACID, Heme Iron Polypeptide, IRON DEXTRAN, Potassium Iodide, Zinc Oxide, Selenium, CUPRIC SULFATE, CHOLECALCIFEROL, THIAMINE MONONITRATE, ALPHA-TOCOPHEROL SUCCINATE, D-, RIBOFLAVIN, NIACINAMIDE, TABLET ORAL 20100927 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC ALPHA-TOCOPHEROL SUCCINATE, D-; BIOTIN; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENIUM; THIAMINE MONONITRATE; ZINC OXIDE 10; 30; 10; 400; .8; 12; 1; 6; 28; 17; 250; 50; 1.6; 65; 1.5; 4.5 [iU]/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 68220-085_ff690efc-acac-4103-98ad-3a1613dc5573 68220-085 HUMAN PRESCRIPTION DRUG BiferaRx FOLIC ACID, Heme Iron Polypeptide, IRON DEXTRAN, and CYANOCOBALAMIN TABLET ORAL 20100501 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC CYANOCOBALAMIN; FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN 25; 1; 6; 22 ug/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 68220-086_69e082a6-77dd-46e0-b3eb-90bb6d167b82 68220-086 HUMAN PRESCRIPTION DRUG PreferaOB One folic acid, heme iron polypeptide, iron dextran, potassium iodide, zinc oxide, ascorbic acid, cholecalciferol, doconexent, .alpha.-tocopherol acetate, dl-, niacinamide, pyridoxine hydrochloride, cyano CAPSULE ORAL 20100401 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; ZINC OXIDE 10; 25; 30; 10; 400; 12; 200; 1; 6; 22; 17; 175; 50; 15 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 68220-089_c697dfae-210c-43a6-b893-f3054e74901c 68220-089 HUMAN PRESCRIPTION DRUG Prefera OB plus DHA FOLIC ACID, Heme Iron Polypeptide, IRON DEXTRAN, Potassium Iodide, Zinc Oxide, Selenium, CUPRIC SULFATE, CHOLECALCIFEROL, THIAMINE MONONITRATE, ALPHA-TOCOPHEROL SUCCINATE, D-, RIBOFLAVIN, NIACINAMIDE, TABLET ORAL 20090401 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC ALPHA-TOCOPHEROL SUCCINATE, D-; BIOTIN; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SELENIUM; THIAMINE MONONITRATE; ZINC OXIDE 10; 30; 10; 400; .8; 12; 1; 6; 22; 17; 175; 50; 1.6; 65; 1.5; 15 [iU]/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1 Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 68220-111_034da52b-7d64-4126-b918-3df9eb478ba2 68220-111 HUMAN PRESCRIPTION DRUG Levsin HYOSCYAMINE SULFATE INJECTION, SOLUTION SUBCUTANEOUS 20081201 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC HYOSCYAMINE SULFATE .5 mg/mL 68220-112_df2a7cba-b81a-4c69-91d9-cbe23cc4a15c 68220-112 HUMAN PRESCRIPTION DRUG Levsin hyoscyamine sulfate TABLET ORAL 19550601 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC HYOSCYAMINE SULFATE .125 mg/1 68220-113_f38ece40-b890-11e2-9e96-0800200c9a66 68220-113 HUMAN PRESCRIPTION DRUG Levsin SL hyoscyamine sulfate TABLET, ORALLY DISINTEGRATING ORAL 20081201 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC HYOSCYAMINE SULFATE .125 mg/1 68220-118_ae2a78b1-b811-11e2-9e96-0800200c9a66 68220-118 HUMAN PRESCRIPTION DRUG NuLev hyoscyamine sulfate TABLET, CHEWABLE ORAL 20081201 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC HYOSCYAMINE SULFATE .125 mg/1 68220-130_98c68a99-158c-11e3-8ffd-0800200c9a66 68220-130 HUMAN PRESCRIPTION DRUG Colyte with flavor packs Polyethylene glycol 3350, Sodium chloride, Potassium chloride, Sodium bicarbonate, and Sodium sulfate POWDER, FOR SOLUTION NASOGASTRIC; ORAL 19990407 NDA NDA018983 Alaven Pharmaceutical LLC POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE 240; 2.98; 6.72; 5.84; 22.72 g/4L; g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68220-131_e0274a28-194d-4d9e-9421-61e399ff0b9b 68220-131 HUMAN PRESCRIPTION DRUG TRILYTE with flavor packs Polyethylene Glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride POWDER, FOR SOLUTION NASOGASTRIC; ORAL 20040624 ANDA ANDA076491 Alaven Pharmaceutical LLC POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420; 1.48; 5.72; 11.2 g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68220-133_98c68a88-158c-11e3-8ffd-0800200c9a66 68220-133 HUMAN PRESCRIPTION DRUG Colyte POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE, and SODIUM SULFATE ANHYDROUS POWDER, FOR SOLUTION NASOGASTRIC; ORAL 20100901 NDA NDA018983 Alaven Pharmaceutical LLC POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE 227.1; 2.82; 6.36; 5.53; 21.5 g/3.785L; g/3.785L; g/3.785L; g/3.785L; g/3.785L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68220-140_90bba35d-271b-4c95-9dde-6e4d43f97822 68220-140 HUMAN PRESCRIPTION DRUG Cortifoam hydrocortisone acetate AEROSOL, FOAM RECTAL 19820212 NDA NDA017351 Alaven Pharmaceutical LLC HYDROCORTISONE ACETATE 1500 mg/15g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68220-141_02ef1480-500b-11e0-b8af-0800200c9a66 68220-141 HUMAN PRESCRIPTION DRUG Proctocream HC Hydrocortisone CREAM TOPICAL 20110318 ANDA ANDA089414 Alaven Pharmaceutical LLC HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68220-142_6a3a7450-e6f4-11e1-aff1-0800200c9a66 68220-142 HUMAN PRESCRIPTION DRUG Proctofoam HC hydrocortisone acetate and pramoxine hydrochloride AEROSOL, FOAM TOPICAL 19780726 ANDA ANDA086195 Alaven Pharmaceutical LLC HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 100; 100 mg/10g; mg/10g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68220-143_f2bdbe25-0124-4b39-ab04-77d2250b5835 68220-143 HUMAN OTC DRUG Proctofoam pramoxine hydrochloride AEROSOL, FOAM RECTAL 19900930 OTC MONOGRAPH FINAL part346 Alaven Pharmaceutical LLC PRAMOXINE HYDROCHLORIDE 150 mg/15g 68220-144_cc56b07d-845a-4729-ad94-ee691215afac 68220-144 HUMAN PRESCRIPTION DRUG Epifoam hydrocortisone acetate and pramoxine hydrochloride AEROSOL, FOAM TOPICAL 19791219 ANDA ANDA086457 Alaven Pharmaceutical LLC HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 100; 100 mg/10g; mg/10g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68220-160_6394448c-9f58-4243-be16-b52fd228ad04 68220-160 HUMAN PRESCRIPTION DRUG Dipentum olsalazine sodium CAPSULE, GELATIN COATED ORAL 19900731 NDA NDA019715 Alaven Pharmaceutical LLC OLSALAZINE SODIUM 250 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 68229-100_be0fda7c-9a8d-489e-b636-e58e57b0c6d6 68229-100 HUMAN OTC DRUG Skin Tag Relief Thuja Occidentalis Leafy Twig OIL TOPICAL 20130521 UNAPPROVED HOMEOPATHIC Quest Products, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/10mL 68229-200_cdb574f7-23b3-4f99-8b63-a92f5625a76a 68229-200 HUMAN OTC DRUG Alocane Lidocaine Hydrochloride OINTMENT TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part348 Quest Products, Inc. LIDOCAINE HYDROCHLORIDE 4 g/100mL 68229-300_a88a45f5-28ad-48b7-bcc6-87c75b15ede3 68229-300 HUMAN OTC DRUG Alocane Plus Lidocaine Hydrochloride and Benzalkonium Chloride OINTMENT TOPICAL 20131211 OTC MONOGRAPH NOT FINAL part348 Quest Products, Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .13; 4 g/100mL; g/100mL 68233-011_8f7da638-8b96-48c6-b747-b37d6332d6ad 68233-011 HUMAN OTC DRUG Max Revive MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20030901 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL; METHYL SALICYLATE .05; .005 g/g; g/g 68233-012_8e0ab908-76d4-4767-9512-99a37aaa056c 68233-012 HUMAN OTC DRUG Herbal UTAPLAS.TN MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20041201 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL; METHYL SALICYLATE .05; .005 g/g; g/g 68233-021_78f91c58-6d48-4ef0-85a2-2f38f973ce4b 68233-021 HUMAN OTC DRUG PAIN FREE MENTHOL, METHYL SALYCILATE, BORNEOL OINTMENT TOPICAL 20051101 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. BORNEOL; MENTHOL; METHYL SALICYLATE .02; .02; .01 g/g; g/g; g/g 68233-031_68da1c7d-cdc0-4152-9e52-a82d35dbbac0 68233-031 HUMAN OTC DRUG Max Revive MENTHOL, METHYL SALICYLATE SPRAY TOPICAL 20030901 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL; METHYL SALICYLATE .0781; .0302 g/mL; g/mL 68233-901_5343a067-6336-4fdc-b309-26065a5148e5 68233-901 HUMAN OTC DRUG Herbal UTAPLAS.TN MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20041201 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL; METHYL SALICYLATE .05; .01 g/g; g/g 68233-902_0093fb0e-d3ec-451f-8a78-edc85a760374 68233-902 HUMAN OTC DRUG Max Revive MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20030901 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL; METHYL SALICYLATE .05; .01 g/g; g/g 68258-1104_0f8b0d18-94a9-4e99-a354-0f0fc40039dd 68258-1104 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20110818 ANDA ANDA091211 Dispensing Solutions, Inc. ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 68258-1107_6b55d24c-094e-4ff0-80af-494574378d75 68258-1107 HUMAN PRESCRIPTION DRUG XIFAXAN RIFAXIMIN TABLET ORAL 20040725 NDA NDA021361 Dispensing Solutions, Inc. RIFAXIMIN 200 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] 68258-1972_dbcafc5a-44f8-4f8f-92ed-ed6c3b466f6e 68258-1972 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20100618 NDA NDA021906 Dispensing Solutions, Inc. LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA] 68258-2003_c8366081-d57b-4c2e-8000-d4c607d6029f 68258-2003 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20091113 ANDA ANDA078783 Dispensing Solutions, Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 68258-2012_602e7e89-3dfe-40fe-82ae-de285a2496f6 68258-2012 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Butalbital, Acetaminophen, Caffeine and Codeine Phosphate CAPSULE ORAL 20040701 ANDA ANDA076560 Dispensing Solutions, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII 68258-2992_be0d579b-3b66-4227-b532-b0ee186a24ad 68258-2992 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20091029 ANDA ANDA077086 Dispensing Solutions, Inc. LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] 68258-2993_c13a4b50-3fd0-4242-a7e8-09516ec2ea08 68258-2993 HUMAN OTC DRUG MEDROX MENTHOL, CAPSAICIN PATCH TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part348 Dispensing Solutions, Inc. CAPSAICIN; MENTHOL .0375; 5 g/100g; g/100g 68258-2994_a601000f-dbf5-4d7b-b1d2-72bfb36db5ea 68258-2994 HUMAN OTC DRUG Good Sense ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20041109 ANDA ANDA076359 Dispensing Solutions, Inc. IBUPROFEN 100 mg/1 68258-2997_9dc38d56-7e5a-4938-b63b-6ca4aecbca94 68258-2997 HUMAN OTC DRUG Dendracin Neurodendraxcin Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20110722 OTC MONOGRAPH NOT FINAL part348 Dispensing Solutions, Inc. CAPSAICIN; MENTHOL; METHYL SALICYLATE .025; 10; 30 g/60mL; g/60mL; g/60mL 68258-3000_c5e7e4ab-39fc-4095-818e-c1e43fb1d77b 68258-3000 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090413 ANDA ANDA090278 Dispensing Solutions Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68258-3001_c5e7e4ab-39fc-4095-818e-c1e43fb1d77b 68258-3001 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090413 ANDA ANDA090278 Dispensing Solutions Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68258-3002_c5e7e4ab-39fc-4095-818e-c1e43fb1d77b 68258-3002 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090413 ANDA ANDA090278 Dispensing Solutions Inc. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68258-3006_26c7935e-4425-4a24-a7af-caa1db3585a1 68258-3006 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20090122 ANDA ANDA075616 Dispensing Solutions Inc. NIZATIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68258-3008_88e7bd4f-82ac-4d50-bbb1-a30340412e80 68258-3008 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET, FILM COATED ORAL 20090303 NDA NDA020132 Dispensing Solutions Inc. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68258-3009_88e7bd4f-82ac-4d50-bbb1-a30340412e80 68258-3009 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET, FILM COATED ORAL 20090303 NDA NDA020132 Dispensing Solutions Inc. SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68258-3011_8ea345d3-5453-4c02-bbfd-55f0bdacffb2 68258-3011 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE SUPPOSITORY RECTAL 20031219 ANDA ANDA123456 Dispensing Solutions Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68258-3012_9203a55b-aa44-428c-890a-58208fd01bf4 68258-3012 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080530 ANDA ANDA065405 Dispensing Solutions Inc. AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68258-3013_e048ce21-7296-4163-9528-8a1b7c9d6ad1 68258-3013 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20080529 ANDA ANDA040256 Dispensing Solutions Inc. PREDNISONE 5 mg/1 68258-3014_8de3b358-74d1-485b-bf3d-f70a6140bf81 68258-3014 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20090303 ANDA ANDA076984 Dispensing Solutions Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 68258-3016_06275476-cfae-4a8b-91bb-3c812d50ff86 68258-3016 HUMAN PRESCRIPTION DRUG LIDODERM lidocaine PATCH CUTANEOUS 19990320 NDA NDA020612 Dispensing Solutions, Inc. LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 68258-3023_0cd9cc40-f972-4d65-8d4a-cff05c03ad07 68258-3023 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20061106 ANDA ANDA077449 Dispensing Solutions Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68258-3024_0cd9cc40-f972-4d65-8d4a-cff05c03ad07 68258-3024 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20061106 ANDA ANDA077449 Dispensing Solutions Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68258-3025_0cd9cc40-f972-4d65-8d4a-cff05c03ad07 68258-3025 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20061106 ANDA ANDA077449 Dispensing Solutions Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68258-3028_71576bbf-c1ec-4747-9e44-5b0923c96cbe 68258-3028 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090528 ANDA ANDA083312 Dispensing Solutions Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68258-3029_dcfe1d2f-5f47-4d8d-9afb-b33d7425dff5 68258-3029 HUMAN PRESCRIPTION DRUG Next Choice levonorgestrel TABLET ORAL 20090904 ANDA ANDA078665 Dispensing Solutions, Inc. LEVONORGESTREL .75 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 68258-3030_342b7e19-49d6-4d0b-950a-cc00f4b79924 68258-3030 HUMAN PRESCRIPTION DRUG RELENZA zanamivir POWDER RESPIRATORY (INHALATION) 20021222 NDA NDA021036 Dispensing Solutions Inc. ZANAMIVIR 5 mg/1 Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] 68258-3031_e96f8cfb-3613-4b43-86eb-25efe9f2e601 68258-3031 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER ORAL; RESPIRATORY (INHALATION) 20010205 NDA NDA021077 Dispensing Solutions Inc. FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 250; 50 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68258-3032_6f5962a5-487d-4d7d-a3eb-ec9d1e77caca 68258-3032 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 20091008 NDA NDA020830 Dispensing Solutions Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 68258-3033_6f5962a5-487d-4d7d-a3eb-ec9d1e77caca 68258-3033 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, FILM COATED ORAL 20091008 NDA NDA020829 Dispensing Solutions Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 68258-3034_5fc17019-fe62-4eb2-96af-c79467313ed2 68258-3034 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET OCCLUSIVE DRESSING TECHNIQUE 19990715 NDA NDA021073 Dispensing Solutions, Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 68258-3035_f7d4a75c-bde1-4166-b6f8-70b8df2e7fe9 68258-3035 HUMAN PRESCRIPTION DRUG Mucinex D Guaifenesin and Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20080208 NDA NDA021585 Dispensing Solutions Inc. GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] 68258-3036_db169f6d-67b5-4328-9796-fdf7a57422be 68258-3036 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040923 ANDA ANDA077253 Dispensing Solutions Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68258-3037_0c9aea94-8edb-47c6-844d-27c0877f65c3 68258-3037 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20090722 NDA NDA020983 Dispensing Solutions Inc. ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 68258-3040_10d4c04c-52d8-4692-b1a7-660ddb87dff7 68258-3040 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20041001 NDA NDA019813 Dispensing Solutions, Inc. FENTANYL 12 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68258-3042_f11aa988-f958-4f75-ab9b-89c24998faff 68258-3042 HUMAN PRESCRIPTION DRUG ENGERIX-B Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR 20090528 BLA BLA103239 Dispensing Solutions Inc. HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 20 ug/mL 68258-3046_74567b8a-65a1-45be-8f6d-12261d9118ef 68258-3046 HUMAN PRESCRIPTION DRUG Nystatin nystatin CREAM TOPICAL 20060531 ANDA ANDA065315 Dispensing Solutions, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 68258-3051_3d465feb-afd8-4252-9c9e-3a4be10a6ebd 68258-3051 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 19990212 NDA NDA050693 Dispensing Solutions, Inc. AZITHROMYCIN 1 g/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68258-3053_d42fd817-f90a-4077-9db6-d7a7014d7aaa 68258-3053 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070501 ANDA ANDA065259 Dispensing Solutions, Inc. CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68258-3978_52eeaf00-babe-4eab-916f-47834846eec4 68258-3978 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20061110 ANDA ANDA087385 Dispensing Solutions, Inc. TRIAMCINOLONE ACETONIDE 5 mg/g 68258-3981_2ea41ae0-8f33-4902-bff1-606437d1da9c 68258-3981 HUMAN OTC DRUG New Terocin Methyl Salicylate, Capsaicin, and Menthol LOTION TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part348 Dispensing Solutions, Inc. CAPSAICIN; MENTHOL; METHYL SALICYLATE .025; 10; 25 g/100mL; g/100mL; g/100mL 68258-3984_77c9d2e7-6ce0-43dd-9537-a01d087e4d2d 68258-3984 HUMAN OTC DRUG Medrox METHYL SALICYLATE, MENTHOL, CAPSAICIN OINTMENT TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part348 Dispensing Solutions, Inc. CAPSAICIN; MENTHOL; METHYL SALICYLATE .0375; 5; 20 g/100g; g/100g; g/100g 68258-3996_6b02cebe-eea9-464f-88eb-7c9db13b79fc 68258-3996 HUMAN PRESCRIPTION DRUG Ciclopirox Olamine Ciclopirox Olamine CREAM TOPICAL 20091113 ANDA ANDA090273 Dispensing Solutions, Inc. CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 68258-3997_66802b4e-32f9-42a2-bb4a-b6aa7734b1e3 68258-3997 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20061018 ANDA ANDA077401 Dispensing Solutions, Inc. MOMETASONE FUROATE 1 mg/g 68258-3998_3f184545-ae45-4fcb-a640-930401accb0b 68258-3998 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 Dispensing Solutions, Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68258-4985_cf4f9c26-4eda-4269-a918-39e87c35beb7 68258-4985 HUMAN OTC DRUG Laxacin Docusate sodium and sennosides TABLET ORAL 20111001 OTC MONOGRAPH NOT FINAL part334 Dispensing Solutions, Inc. DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 68258-4987_8b728ea1-486f-4d61-b7c9-1ad8ce994dd4 68258-4987 HUMAN OTC DRUG Promolaxin Docusate sodium TABLET ORAL 20110415 OTC MONOGRAPH NOT FINAL part334 Dispensing Solutions, Inc. DOCUSATE SODIUM 100 mg/1 68258-5005_bb5b62e3-b229-4c86-ab21-8f21eeb82d50 68258-5005 HUMAN PRESCRIPTION DRUG Necon 777 777 norethindrone and ethinyl estradiol KIT 20021207 NDA NDA018985 Dispensing Solutions, Inc. 68258-5230_5fc17019-fe62-4eb2-96af-c79467313ed2 68258-5230 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET OCCLUSIVE DRESSING TECHNIQUE 19990715 NDA NDA021073 Dispensing Solutions, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] 68258-5948_951444e0-5267-469a-9243-00952fc6b90c 68258-5948 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68258-5972_6c676e5d-352e-4ab5-bb2f-6aceec0e2f3e 68258-5972 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68258-5973_6c676e5d-352e-4ab5-bb2f-6aceec0e2f3e 68258-5973 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68258-5974_6c676e5d-352e-4ab5-bb2f-6aceec0e2f3e 68258-5974 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68258-5978_cb3ae439-62fe-48c7-94de-a6e5f518a973 68258-5978 HUMAN PRESCRIPTION DRUG Prempro conjugated estrogens and medroxyprogesterone acetate TABLET, SUGAR COATED ORAL 20090921 NDA NDA020527 Dispensing Solutions, Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .3; 1.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 68258-5980_cb3ae439-62fe-48c7-94de-a6e5f518a973 68258-5980 HUMAN PRESCRIPTION DRUG Prempro conjugated estrogens and medroxyprogesterone acetate TABLET, SUGAR COATED ORAL 20090921 NDA NDA020527 Dispensing Solutions, Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .625; 2.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 68258-6010_69a5de8c-248f-4613-b495-ea310d23fdfd 68258-6010 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Dispensing Solutions, Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68258-6019_3334d650-acaf-4ae0-bfac-25a6df21476f 68258-6019 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20090804 ANDA ANDA076862 Dispensing Solutions, Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68258-6023_1cae4261-d794-41d6-b8b1-1555852cbbbd 68258-6023 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 Dispensing Solutions, Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68258-6024_0993e676-7476-48e9-8bbb-ee393783ad9f 68258-6024 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Dispensing Solutions, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68258-6031_649fa3d9-0775-4a82-81f8-39c49f9c47f8 68258-6031 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20100406 ANDA ANDA090528 Dispensing Solutions, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68258-6032_bff5e40f-d32d-4ff9-8735-8c326b75fe92 68258-6032 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100629 NDA NDA020381 Dispensing Solutions, Inc. NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 68258-6033_c036bb97-36e7-42d0-a807-2f30a7503ca7 68258-6033 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20040115 ANDA ANDA076670 Dispensing Solutions, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68258-6034_2990467e-9e2d-4a9d-ba40-64675ae2a5e5 68258-6034 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081001 ANDA ANDA074501 Dispensing Solutions, Inc. NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68258-6036_8e2b971c-d0c4-4016-b62f-08488a6ec166 68258-6036 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20051117 ANDA ANDA077321 Dispensing Solutions, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68258-6037_569ac5fc-e35b-4e0e-97d1-9327a1c1b511 68258-6037 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970728 NDA NDA020381 Dispensing Solutions, Inc. NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 68258-6040_17c70627-857f-40ad-836e-2b15336bd8d6 68258-6040 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20101004 ANDA ANDA078235 Dispensing Solutions, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68258-6041_1667ff8f-da0d-4026-8ba5-e1444f57bbd4 68258-6041 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Dispensing Solutions, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68258-6042_1667ff8f-da0d-4026-8ba5-e1444f57bbd4 68258-6042 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Dispensing Solutions, Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68258-6043_1667ff8f-da0d-4026-8ba5-e1444f57bbd4 68258-6043 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Dispensing Solutions, Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68258-6044_1667ff8f-da0d-4026-8ba5-e1444f57bbd4 68258-6044 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Dispensing Solutions, Inc. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68258-6046_4eceff12-b13c-429c-b859-d9c0cfddf9f5 68258-6046 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Dispensing Solutions, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68258-6047_85ac20d9-9737-449c-9929-e84c649f5a00 68258-6047 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20110101 ANDA ANDA074787 Dispensing Solutions, Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68258-6053_9dd376a1-3a4f-4e38-ae5a-0f2ae7c310f4 68258-6053 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Dispensing Solutions, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68258-6056_5ce44a1d-f91e-4cd8-a51c-6993bbb9e56e 68258-6056 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Dispensing Solutions, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68258-6095_c2f46e16-af36-41ea-a860-47f23b9612b4 68258-6095 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 NDA AUTHORIZED GENERIC NDA020818 Dispensing Solutions, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68258-6096_c2f46e16-af36-41ea-a860-47f23b9612b4 68258-6096 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 NDA AUTHORIZED GENERIC NDA020818 Dispensing Solutions, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68258-6099_d5178c9e-f740-42a9-a93d-3f554095a1da 68258-6099 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20040610 ANDA ANDA076161 Dispensing Solutions, Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68258-6100_67029d98-f499-4123-a1e9-6422f0e72c0d 68258-6100 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070207 ANDA ANDA077489 Dispensing Solutions, Inc. TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68258-6106_649f5bc7-7ee3-42bd-84b0-8a0650a9582c 68258-6106 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040423 ANDA ANDA076483 Dispensing Solutions, Inc. FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68258-6969_21fa3398-430e-465d-8ef4-6b06d781fda5 68258-6969 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Dispensing Solutions, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68258-6972_1b1be459-a727-487a-aefd-f3c3757b6cc9 68258-6972 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Dispensing Solutions, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68258-6973_1b1be459-a727-487a-aefd-f3c3757b6cc9 68258-6973 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Dispensing Solutions, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68258-6992_cbd5e14a-1476-490d-8ab4-308ea767b51f 68258-6992 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Dispensing Solutions, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68258-6993_cbd5e14a-1476-490d-8ab4-308ea767b51f 68258-6993 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Dispensing Solutions, Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68258-7001_865ab1fc-2dc9-43bd-8c7e-0ad3763b9dcc 68258-7001 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED OCCLUSIVE DRESSING TECHNIQUE 20000207 ANDA ANDA075584 Dispensing Solutions, Inc. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68258-7013_e42a2997-38cb-4a35-be8b-b7a4bc9a0075 68258-7013 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 Dispensing Solutions, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68258-7047_fa5746b6-3e07-423b-8fcb-660fd1404475 68258-7047 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Dispensing Solutions, Inc. PREGABALIN 150 mg/1 CV 68258-7048_abf41383-30a2-43ec-b4d3-1c17836b8900 68258-7048 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 Dispensing Solutions, Inc. ESZOPICLONE 2 mg/1 CIV 68258-7049_abf41383-30a2-43ec-b4d3-1c17836b8900 68258-7049 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 Dispensing Solutions, Inc. ESZOPICLONE 3 mg/1 CIV 68258-7056_c5e7e4ab-39fc-4095-818e-c1e43fb1d77b 68258-7056 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090413 ANDA ANDA090278 Dispensing Solutions Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68258-7067_e8cf3fb8-27c3-4e9f-8db4-8cc6d93566e2 68258-7067 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070613 ANDA ANDA077715 Dispensing Solutions, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68258-7068_212b3aaa-746d-4702-9789-8fee4e9be397 68258-7068 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Dispensing Solutions, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68258-7077_1a577f08-1a85-45a0-81b9-265be154dc66 68258-7077 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071207 Dispensing Solutions, Inc. HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] 68258-7087_8df6cacc-6679-47e3-98cb-8e9ab984421a 68258-7087 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Dispensing Solutions, Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 68258-7089_39ab0a80-121a-41ac-94b8-de8165fbd7b0 68258-7089 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Dispensing Solutions, Inc. LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68258-7090_32a1e443-4d13-47ea-a3fb-85e4de4d8845 68258-7090 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19970623 NDA NDA020592 Dispensing Solutions, Inc. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 68258-7091_32a1e443-4d13-47ea-a3fb-85e4de4d8845 68258-7091 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 Dispensing Solutions, Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 68258-7092_32a1e443-4d13-47ea-a3fb-85e4de4d8845 68258-7092 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 Dispensing Solutions, Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 68258-7093_32a1e443-4d13-47ea-a3fb-85e4de4d8845 68258-7093 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20000110 NDA NDA020592 Dispensing Solutions, Inc. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 68258-7095_2e7299de-62ca-4372-94ce-62f5621a930f 68258-7095 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Dispensing Solutions, Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] 68258-7096_2e7299de-62ca-4372-94ce-62f5621a930f 68258-7096 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Dispensing Solutions, Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] 68258-7100_86de2f42-f64d-4801-98a8-b879a4779840 68258-7100 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 Dispensing Solutions, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68258-7103_9a4bcae1-f67a-443e-a946-8e92cebbc01f 68258-7103 HUMAN PRESCRIPTION DRUG ZOMIG Zolmitriptan TABLET ORAL 20100518 NDA NDA020768 Dispensing Solutions, Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68258-7114_c89655ee-1e40-4aea-838a-31efde68e839 68258-7114 HUMAN PRESCRIPTION DRUG sumatriptan succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA078295 Dispensing Solutions, Inc. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68258-7126_e8cf3fb8-27c3-4e9f-8db4-8cc6d93566e2 68258-7126 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081126 ANDA ANDA077715 Dispensing Solutions, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68258-7128_c36c58df-fc65-4072-ac8c-3b168c2bcd1b 68258-7128 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 Dispensing Solutions, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68258-7150_666a7201-2cec-49a0-b590-8e9866958b0b 68258-7150 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20110829 ANDA ANDA078722 Dispensing Solutions, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68258-7152_f546cd57-6d18-4096-a519-c12c62ec817c 68258-7152 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Dispensing Solutions, Inc. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] 68258-7153_f546cd57-6d18-4096-a519-c12c62ec817c 68258-7153 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Dispensing Solutions, Inc. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] 68258-7154_f546cd57-6d18-4096-a519-c12c62ec817c 68258-7154 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Dispensing Solutions, Inc. OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] 68258-7156_29d8c0dd-978b-49e3-be25-8e80b1ae0823 68258-7156 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Dispensing Solutions, Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68258-7157_1638838c-d5e5-46f3-b5f1-f8332b3beb42 68258-7157 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 Dispensing Solutions, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68258-7159_3883ec95-e22d-4190-aa4a-c85b5cbc11f6 68258-7159 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Dispensing Solutions, Inc. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68258-7160_e4a5719d-bb90-435d-a9ef-604023aae517 68258-7160 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Dispensing Solutions, Inc. AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] 68258-7162_ec4d59ce-00e6-4dcd-a59b-ff74d334eec4 68258-7162 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090918 ANDA ANDA090429 Dispensing Solutions, Inc. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68258-7163_c5dd57e1-930a-4942-97ac-2b63f1d9a7f2 68258-7163 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Dispensing Solutions, Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68258-7980_04ac4476-c8ce-4c16-a8d5-484492d52c5d 68258-7980 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Dispensing Solutions, Inc. PREGABALIN 75 mg/1 CV 68258-7981_d0d3dac4-a8c8-4c05-abfa-aad2ee2f41f6 68258-7981 HUMAN PRESCRIPTION DRUG modafinil modafinil TABLET ORAL 20120329 NDA AUTHORIZED GENERIC NDA020717 Dispensing Solutions, Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV 68258-7991_4b7832cb-8420-47b0-b947-363aa54e2ca1 68258-7991 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex LOZENGE ORAL 20091128 ANDA ANDA077007 Dispensing Solutions, Inc. NICOTINE 2 mg/1 68258-7992_40855932-0f9c-4ee0-96a5-4512c6ba9d66 68258-7992 HUMAN OTC DRUG good sense nicotine Nicotine Polacrilex LOZENGE ORAL 20061227 ANDA ANDA077007 Dispensing Solutions, Inc. NICOTINE 4 mg/1 68258-8000_7c6d5ac1-5bee-4c72-8240-10a7f2568260 68258-8000 HUMAN OTC DRUG Rugby Nasal Decongestant Nasal Decongestant Pseudoephedrine Hydrochloride LIQUID ORAL 19990726 OTC MONOGRAPH FINAL part341 Dispensing Solutions, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5mL 68258-8001_fa09c411-6ac1-4d89-8eaa-7e8810bba033 68258-8001 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP OCCLUSIVE DRESSING TECHNIQUE 19980130 ANDA ANDA074749 Dispensing Solutions, Inc. ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 68258-8899_5d8213bc-800b-4e52-af9e-3ba3e5f2650c 68258-8899 HUMAN PRESCRIPTION DRUG NovoLog insulin aspart INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20030122 NDA NDA020986 Dispensing Solutions, Inc. INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 68258-8900_02ad0855-49aa-44a6-80ef-e8a0be13eec2 68258-8900 HUMAN OTC DRUG good neighbor pharmacy eye itch relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20101113 ANDA ANDA077958 Dispensing Solutions, Inc. KETOTIFEN FUMARATE .25 mg/mL 68258-8902_1876c780-20ee-4f51-91a1-f7ae376a2dda 68258-8902 HUMAN OTC DRUG Good Neighbor Pharmacy Ibuprofen Cold and Sinus Ibuprofen, Pseudoephedrine Hydrochloride TABLET ORAL 20011015 ANDA ANDA074567 Dispensing Solutions, Inc. IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 68258-8903_af60c3f8-367c-431b-bf14-c9927b2abdce 68258-8903 HUMAN PRESCRIPTION DRUG KENALOG-10 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL 20090601 NDA NDA012041 Dispensing Solutions, Inc. TRIAMCINOLONE ACETONIDE 10 mg/mL 68258-8904_ef2f000e-865b-4a31-831f-eef6ca717f7a 68258-8904 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate SOLUTION ORAL 20061001 OTC MONOGRAPH FINAL part341 Dispensing Solutions, Inc. CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 68258-8905_e606d0c5-b79d-4687-8d3c-24a0c4b5f101 68258-8905 HUMAN OTC DRUG good sense tussin dm cough and chest congestion Dextromethorphan HBr, Guaifenesin LIQUID ORAL 19940920 OTC MONOGRAPH FINAL part341 Dispensing Solutions, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 68258-8907_2f0453e0-6c62-4ee0-94d8-5c354adb562d 68258-8907 HUMAN OTC DRUG Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080410 ANDA ANDA077170 Dispensing Solutions, Inc. CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 68258-8910_b530e3ad-d9c7-4946-b19e-eef2ca16e407 68258-8910 HUMAN PRESCRIPTION DRUG BICILLIN CR penicillin G benzathine and penicillin G procaine INJECTION, SUSPENSION INTRAMUSCULAR 19530518 NDA NDA050138 Dispensing Solutions, Inc. PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE 600000; 600000 [iU]/2mL; [iU]/2mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 68258-8912_c319ee15-43a9-4864-a4c1-40ffb50d9e5a 68258-8912 VACCINE HAVRIX Hepatitis A Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20070413 BLA BLA103475 Dispensing Solutions, Inc. HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 1440 [iU]/mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] 68258-8922_478e24f9-c2b6-4b8e-bfff-73f19b671e86 68258-8922 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20081119 ANDA ANDA077519 Dispensing Solutions, Inc. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68258-8961_198f20a2-218e-4a0f-a4c1-ae7c3b62e1c6 68258-8961 HUMAN PRESCRIPTION DRUG SEREVENT DISKUS salmeterol xinafoate POWDER, METERED ORAL; RESPIRATORY (INHALATION) 19971125 NDA NDA020692 Dispensing Solutions, Inc. SALMETEROL XINAFOATE 50 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 68258-8973_8c80bd8d-d5cf-41a5-8391-0a2fc4a76dee 68258-8973 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110502 ANDA ANDA075857 Dispensing Solutions, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68258-8976_309e27fc-3503-4307-880c-2d9492423870 68258-8976 HUMAN PRESCRIPTION DRUG Xalatan latanoprost SOLUTION OPHTHALMIC 19950320 NDA NDA020597 Dispensing Solutions, Inc. LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] 68258-8977_082bc713-cea6-4af8-b2be-65622cb897d0 68258-8977 HUMAN PRESCRIPTION DRUG Levemir insulin detemir IMPLANT SOFT TISSUE 20060327 NDA NDA021536 Dispensing Solutions, Inc. INSULIN DETEMIR 14.2 mg/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] 68258-8978_d9c34849-a809-4a5c-884d-b877006a7e3a 68258-8978 HUMAN PRESCRIPTION DRUG Cefazolin cefazolin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090201 ANDA ANDA063207 Dispensing Solutions, Inc. CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68258-8981_b5c3b5fc-3d14-4da6-8b9e-dc04ba5cab51 68258-8981 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110503 ANDA ANDA075293 Dispensing Solutions, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68258-8987_85f672a6-a6bb-40af-944c-b7a2d3a5af74 68258-8987 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 20030227 ANDA ANDA040401 Dispensing Solutions, Inc. PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68275-320_2e956093-0266-4a5a-8926-610a8ff7cdfd 68275-320 HUMAN PRESCRIPTION DRUG Colocynthis Homaccord GNAPHALIUM and CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20090909 UNAPPROVED HOMEOPATHIC JENAHEXAL PHARMA GMBH CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED; CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED; CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED; CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED; GNAPHALIUM; GNAPHALIUM; GNAPHALIUM; GNAPHALIUM 10; 200; 30; 4; 10; 200; 3; 30 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL 68276-004_fe6a7986-2443-4e19-a830-42b4aa604e13 68276-004 HUMAN OTC DRUG Bouton Eye Wash Water RINSE OPHTHALMIC 20100115 OTC MONOGRAPH FINAL part349 Aaxis Pacific WATER 98.6 mL/100mL 68276-005_80984d7b-efbd-452b-aea4-8f1d83d5ee25 68276-005 HUMAN OTC DRUG Salinaax Eye Wash and Skin Flush Water RINSE OPHTHALMIC 20110311 OTC MONOGRAPH FINAL part349 Aaxis Pacific WATER 98.6 mL/100mL 68276-006_60803d8a-3927-4e56-9af4-88221b9ebc3d 68276-006 HUMAN OTC DRUG Salinaax Eye Wash Water RINSE OPHTHALMIC 20100618 OTC MONOGRAPH FINAL part349 Aaxis Pacific WATER 98.6 mL/100mL 68289-008_24fc53ef-d9ef-401a-8bbe-3fc0d76a6cf8 68289-008 HUMAN PRESCRIPTION DRUG Cephalexin USP Cephalexin SUSPENSION ORAL 20090901 ANDA ANDA065444 Jazeera Pharmaceutical CEPHALEXIN ANHYDROUS 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68289-009_24fc53ef-d9ef-401a-8bbe-3fc0d76a6cf8 68289-009 HUMAN PRESCRIPTION DRUG Cephalexin USP Cephalexin SUSPENSION ORAL 20090901 ANDA ANDA065444 Jazeera Pharmaceutical CEPHALEXIN ANHYDROUS 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68304-141_374a861e-f2b7-499e-b3aa-783768cb9630 68304-141 HUMAN OTC DRUG Supreme Chloroxylenol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Brookmeade Hardware & Supply Co. CHLOROXYLENOL 3.75 mg/mL 68306-101_33c89e2f-3332-4e25-ac2c-cdcc0acae918 68306-101 HUMAN OTC DRUG Avant Original Instant Hand Sanitizer Alcohol GEL TOPICAL 20101005 OTC MONOGRAPH NOT FINAL part333E B4 Ventures LLC ALCOHOL 60 mL/100mL 68306-104_3b716461-0dfd-42f9-8e5c-d4d12fe05f70 68306-104 HUMAN OTC DRUG Avant EX Alcohol GEL TOPICAL 20100515 OTC MONOGRAPH NOT FINAL part333E B4 Ventures LLC ALCOHOL 70 mL/100mL 68306-105_db364ab9-aea4-41e8-9825-08cf7abd1bd6 68306-105 HUMAN OTC DRUG Aterra Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20101118 OTC MONOGRAPH NOT FINAL part333E B4 Ventures LLC TRICLOSAN 3 mL/1000mL 68306-106_e1c93cb4-1416-47f1-b898-e72031190863 68306-106 HUMAN OTC DRUG Avant Original - Fragrance Free Alcohol GEL TOPICAL 20100515 OTC MONOGRAPH NOT FINAL part333E B4 Ventures LLC ALCOHOL 60 mL/100mL 68306-108_21f2aaae-93f3-4d86-bb43-0ac3035d92c4 68306-108 HUMAN OTC DRUG Aterra Antibacterial Foaming Hand Wash Triclosan SOAP TOPICAL 20101115 OTC MONOGRAPH NOT FINAL part333E B4 Ventures, LLC TRICLOSAN 3 mL/1000mL 68306-109_d301ef51-4da7-4ecb-a9c2-a114f5086532 68306-109 HUMAN OTC DRUG Avant Foaming Hand Sanitizer Alcohol LIQUID TOPICAL 20101208 OTC MONOGRAPH NOT FINAL part333E B4 Ventures LLC ALCOHOL 62 mL/100mL 68306-113_8102e2ec-05b8-4a45-9a15-93370687b1cc 68306-113 HUMAN OTC DRUG Aterra E-2 Sanitizing Foam Hand Wash Benzalkonium Chloride SOAP TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333E B4 Ventures, LLC BENZALKONIUM CHLORIDE 25 mL/1000mL 68306-114_48489051-fba8-49d1-94e9-6027a615b77b 68306-114 HUMAN OTC DRUG Avant Eco-Premium Instant Hand Sanitizer Alcohol GEL TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part333E B4 Ventures LLC ALCOHOL 70 mL/100mL 68308-020_bd101328-bd33-44ce-8625-7c8cc917c4a0 68308-020 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20140612 ANDA ANDA204092 Midlothian Laboratories OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68308-108_4c3af76c-a506-406e-ad93-74e5ce38f1cf 68308-108 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 ANDA ANDA091313 Mayne Pharma OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68308-111_4c3af76c-a506-406e-ad93-74e5ce38f1cf 68308-111 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 ANDA ANDA091313 Mayne Pharma OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68308-112_4c3af76c-a506-406e-ad93-74e5ce38f1cf 68308-112 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 ANDA ANDA091313 Mayne Pharma OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68308-145_e9b6da26-e764-44ee-951e-3d6270d67937 68308-145 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE ORAL 20120731 ANDA ANDA203107 Midlothian Laboratories OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68308-152_38efa04f-1da5-4220-905f-06bf9749fbda 68308-152 HUMAN PRESCRIPTION DRUG Nystatin Nystatin POWDER TOPICAL 20090915 ANDA ANDA065203 Midlothian Laboratories, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 68308-165_7d93ca77-68f9-4b29-ac00-8c9a755e7f7c 68308-165 HUMAN PRESCRIPTION DRUG Foltabs Prenatal Prenatal Vitamins and Minerals Tablets TABLET ORAL 20090101 UNAPPROVED DRUG OTHER Midlothian Laboratories .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CALCIUM CITRATE; CHOLECALCIFEROL; CUPRIC OXIDE; DOCUSATE SODIUM; FERROUS GLUCONATE; FOLIC ACID; IRON PENTACARBONYL; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 30; 120; 125; 400; 2; 50; 13; 1; 14; 20; 150; 30; 3.4; 3; 25 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 68308-167_dd5e102c-0114-4c84-bccc-5d4d15edc5f9 68308-167 HUMAN PRESCRIPTION DRUG Folcaps Care One calcium ascorbate, calcium threonate, Cholecalciferol, ALPHA-TOCOPHERYL ACETATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CALCIUM CARBONATE, IRON, IODINE, MAGNESIUM, ZINC, DOCUSA CAPSULE, GELATIN COATED ORAL 20090501 UNAPPROVED DRUG OTHER Midlothian Laboratories ALPHA-TOCOPHEROL ACETATE; BIOTIN; CALCIUM ASCORBATE; CALCIUM CARBONATE; CALCIUM THREONATE; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; ICOSAPENT; IODINE; IRON; LINOLENIC ACID; MAGNESIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; ZINC 15; 300; 24; 100; 1; 800; 350; 50; 1; 100; 150; 27; 50; 50; 10; 50; 1.5; 5 [iU]/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68308-219_c5827155-c339-4f7e-829b-6cf4edc581af 68308-219 HUMAN PRESCRIPTION DRUG Esgic butalbital, acetaminophen and caffeine CAPSULE ORAL 20140501 ANDA ANDA089007 Midlothian Laboratories ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 68308-220_0fae8fb3-adac-43d4-bf37-785b00b3dab3 68308-220 HUMAN PRESCRIPTION DRUG Esgic butalbital, acetaminophen and caffeine TABLET ORAL 20140501 ANDA ANDA089175 Midlothian Laboratories ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 68308-221_0e7f448e-e0ec-40ce-ba0e-5baece064ee4 68308-221 HUMAN PRESCRIPTION DRUG LORCET Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 ANDA ANDA090118 Midlothian Laboratories ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 68308-222_0e7f448e-e0ec-40ce-ba0e-5baece064ee4 68308-222 HUMAN PRESCRIPTION DRUG LORCET PLUS Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 ANDA ANDA090118 Midlothian Laboratories ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 68308-223_0e7f448e-e0ec-40ce-ba0e-5baece064ee4 68308-223 HUMAN PRESCRIPTION DRUG LORCET HD Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 ANDA ANDA090118 Midlothian Laboratories ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 68308-224_a39c5907-503c-4da6-87bc-95acd6a8c954 68308-224 HUMAN PRESCRIPTION DRUG LORCET Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 ANDA ANDA090118 Mayne Pharma ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 68308-225_a39c5907-503c-4da6-87bc-95acd6a8c954 68308-225 HUMAN PRESCRIPTION DRUG LORCET PLUS Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 ANDA ANDA090118 Mayne Pharma ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 68308-226_a39c5907-503c-4da6-87bc-95acd6a8c954 68308-226 HUMAN PRESCRIPTION DRUG LORCET HD Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 ANDA ANDA090118 Mayne Pharma ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 68308-250_5002cbf2-ac8f-41c8-8a1f-46099a458a7e 68308-250 HUMAN PRESCRIPTION DRUG erythromycin erythromycin CAPSULE, DELAYED RELEASE PELLETS ORAL 20130729 NDA AUTHORIZED GENERIC NDA050536 Midlothian Laboratories ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68308-269_77fab8e2-96c1-4f68-b621-0bf46da87df5 68308-269 HUMAN PRESCRIPTION DRUG Folcaps Omega-3 CALCIUM ASCORBATE, CALCIUM THREONATE, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CALCIUM, IRON, FERROUS ASPARTO GLYCINATE, DOCONEXENT, ICOSAPENT, and LINOLENIC AC CAPSULE, GELATIN COATED ORAL 20110103 UNAPPROVED DRUG OTHER Midlothian Laboratories ALPHA-TOCOPHEROL ACETATE; CALCIUM; CALCIUM ASCORBATE; CALCIUM THREONATE; CHOLECALCIFEROL; DOCONEXENT; FERROUS ASPARTO GLYCINATE; FOLIC ACID; ICOSAPENT; IRON; LINOLENIC ACID; PYRIDOXINE HYDROCHLORIDE 30; 150; 24; 1; 170; 260; 7; 1; 40; 20; 30; 25 [iU]/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] 68308-324_8b0fdb13-30a7-406c-ae5f-cb986179689b 68308-324 HUMAN PRESCRIPTION DRUG Folcaps Vitamins Tablets TABLET ORAL 20090101 UNAPPROVED DRUG OTHER Midlothian Laboratories CYANOCOBALAMIN; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE 500; 2.2; 25 ug/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 68308-325_a0c87255-6105-4ae6-a698-dae0115265ab 68308-325 HUMAN PRESCRIPTION DRUG Foltabs 800 Vitamins Tablets TABLET ORAL 20090101 UNAPPROVED DRUG OTHER Midlothian Laboratories CYANOCOBALAMIN; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE 115; 800; 115 ug/1; ug/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 68308-326_baf8cfad-1ff4-4baf-9179-3dad9d36fbb0 68308-326 HUMAN PRESCRIPTION DRUG FaBB Tablets Vitamins Tablets TABLET ORAL 20090101 UNAPPROVED DRUG OTHER Midlothian Laboratories CYANOCOBALAMIN; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE 1; 2.2; 25 mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 68308-352_c76b9fa3-f6f2-49b1-a251-69d250c25dd9 68308-352 HUMAN PRESCRIPTION DRUG Folcal DHA ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, FERROUS FUMARATE, DOCUSATE SODIUM, DOCONEXENT, and TRIBASIC CALCIUM PHOSPHATE CAPSULE, GELATIN COATED ORAL 20101201 UNAPPROVED DRUG OTHER Midlothian Laboratories ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; TRIBASIC CALCIUM PHOSPHATE 30; 28; 400; 300; 55; 27; 1.25; 25; 160 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 68308-405_682397e3-0835-471f-b8fa-02e498d861a6 68308-405 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Midlothian Laboratories ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68308-475_682397e3-0835-471f-b8fa-02e498d861a6 68308-475 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Midlothian Laboratories ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68308-480_682397e3-0835-471f-b8fa-02e498d861a6 68308-480 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Midlothian Laboratories ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68308-502_cec8bd3a-7b8d-43dd-b815-6a2daf3a1cf6 68308-502 HUMAN PRESCRIPTION DRUG Mi-Omega NF Multiple Vitamin Capsule CAPSULE ORAL 20090101 UNAPPROVED DRUG OTHER Midlothian Laboratories, LLC CYANOCOBALAMIN; FOLIC ACID; OMEGA-3-ACID ETHYL ESTERS; PYRIDOXINE HYDROCHLORIDE; SITOSTEROL, BETA- 500; 1; 500; 12.5; 200 ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 68308-505_0040c308-8be1-4b01-9d63-cefc72ecf76b 68308-505 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 ANDA ANDA091313 Midlothian Laboratories OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68308-554_ac7e8ce7-088f-4d9c-ad52-2af60436d836 68308-554 HUMAN PRESCRIPTION DRUG Zebutal butalbital, acetaminophen and caffeine CAPSULE ORAL 20131226 ANDA ANDA089007 Midlothian Laboratories ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 68308-710_dda5f56c-75ee-4516-bb4c-d68c763e1cba 68308-710 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20130708 NDA AUTHORIZED GENERIC NDA050795 Midlothian Laboratories DOXYCYCLINE HYCLATE 100 mg/1 68308-715_dda5f56c-75ee-4516-bb4c-d68c763e1cba 68308-715 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20140202 NDA AUTHORIZED GENERIC NDA050795 Midlothian Laboratories DOXYCYCLINE HYCLATE 150 mg/1 68308-775_dda5f56c-75ee-4516-bb4c-d68c763e1cba 68308-775 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20130708 NDA AUTHORIZED GENERIC NDA050795 Midlothian Laboratories DOXYCYCLINE HYCLATE 75 mg/1 68308-840_5afca226-41b8-4db8-aaef-a68dc7fb8a2b 68308-840 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Mayne Pharma ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 2.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68308-841_5afca226-41b8-4db8-aaef-a68dc7fb8a2b 68308-841 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Mayne Pharma ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68308-842_5afca226-41b8-4db8-aaef-a68dc7fb8a2b 68308-842 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Mayne Pharma ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68308-843_5afca226-41b8-4db8-aaef-a68dc7fb8a2b 68308-843 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Mayne Pharma ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 10 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68308-910_5c8d104d-feb4-4a1b-aa1c-b2ebbcbc5ccc 68308-910 HUMAN PRESCRIPTION DRUG Iron Chews Mineral Tablet TABLET, CHEWABLE ORAL 20090101 UNAPPROVED DRUG OTHER Midlothian Laboratories IRON PENTACARBONYL 15 mg/1 68327-001_927673ce-8a91-42a2-b425-f99050f14481 68327-001 HUMAN OTC DRUG Total Cover FX OCTOCRYLENE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20120824 OTC MONOGRAPH NOT FINAL part352 Cover FX Skin Care, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8.5 g/100g; g/100g; g/100g 68327-002_45f8e99c-9a20-44ad-bf4b-1cd53d0fb2e5 68327-002 HUMAN OTC DRUG Natural FX OCTINOXATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Cover FX Skin Care, Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3.4; 2.2; .9 g/100mL; g/100mL; g/100mL 68327-003_d9d95792-6a64-4b61-9fe7-10ca55c7f0c4 68327-003 HUMAN OTC DRUG Skin Tint FX OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110920 OTC MONOGRAPH NOT FINAL part352 Cover FX Skin Care, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 6.5; 3.5; 2.1; 5.5; 5.5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 68327-004_bc82ac98-ca84-407d-98fc-af300754202e 68327-004 HUMAN OTC DRUG Mint Glaze FX OCTINOXATE, OXYBENZONE OINTMENT TOPICAL 20100409 OTC MONOGRAPH NOT FINAL part352 Cover FX Skin Care, Inc. OCTINOXATE; OXYBENZONE 7.5; 2.5 g/100mL; g/100mL 68327-005_048bb7e5-b132-4b36-8274-8c8db1c1fb07 68327-005 HUMAN OTC DRUG BritePrep FX OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 Cover FX Skin Care, Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 9; 3; 1.5 g/100mL; g/100mL; g/100mL; g/100mL 68327-006_05ed1245-f8fd-45d1-85ad-5dad98bf568e 68327-006 HUMAN OTC DRUG ClearPrep FX SALICYLIC ACID GEL TOPICAL 20110701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID 1 g/100mL 68327-010_20b2c5ff-19eb-4427-9d33-38c18054d639 68327-010 HUMAN OTC DRUG COVER FX TOTAL COVER FOUNDATION SPF 30 OCTOCRYLENE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Cover FX Skin Care, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8.5 mg/g; mg/g; mg/g 68327-011_217fb307-0671-4325-b80e-8f65e22f0fd0 68327-011 HUMAN OTC DRUG COVER FX PROTECTION PRIMER SPF 30 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 Cover FX Skin Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3.5; 7.5; 5; 11 g/100mL; g/100mL; g/100mL; g/100mL 68327-012_65da03f9-358b-4727-b473-55e9e959d82c 68327-012 HUMAN OTC DRUG COVER FX MATTIFYING PRIMER with ANTI-ACNE TREATMENT SALICYLIC ACID CREAM TOPICAL 20130101 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID 1 mg/100mL 68327-013_8cab26db-e187-4a84-bb83-3e2ba9f40bb6 68327-013 HUMAN OTC DRUG COVER FX CC TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Cover FX Skin Care, Inc. TITANIUM DIOXIDE; ZINC OXIDE 1; 1 mg/10mL; mg/10mL 68327-014_2c63097f-bf2f-4e1e-9e2f-15ac27b5117e 68327-014 HUMAN OTC DRUG COVER FX BLEMISH TREATMENT PRIMER SALICYLIC ACID GEL TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .1425 g/30mL 68327-020_92a829c9-586a-46db-929a-906ca4a817a6 68327-020 HUMAN OTC DRUG Cover Fx BB Gel Mattifying Anti-Blemish N Light SALICYLIC ACID GEL TOPICAL 20140425 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .3 mg/30mL 68327-021_92a829c9-586a-46db-929a-906ca4a817a6 68327-021 HUMAN OTC DRUG Cover Fx BB Gel Mattfying Anti-Blemish N Medium SALICYLIC ACID GEL TOPICAL 20140425 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .3 mg/30mL 68327-022_92a829c9-586a-46db-929a-906ca4a817a6 68327-022 HUMAN OTC DRUG Cover Fx BB Gel Mattfying Anti-Blemish N Deep SALICYLIC ACID GEL TOPICAL 20140425 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .3 mg/30mL 68327-023_1ff25cb9-d376-4369-b896-80445e90b41f 68327-023 HUMAN OTC DRUG Cover Fx BB Gel Mattifying Anti-Blemish N Med-Deep SALICYLIC ACID GEL TOPICAL 20140425 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .3 mg/30mL 68327-024_1ff25cb9-d376-4369-b896-80445e90b41f 68327-024 HUMAN OTC DRUG Cover Fx BB Gel Mattfying Anti-Blemish N X-Deep SALICYLIC ACID GEL TOPICAL 20140425 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .3 mg/30mL 68327-025_2d8c0d42-e15f-4eff-8be0-1d92138ca8d1 68327-025 HUMAN OTC DRUG Cover Fx BB Gel Mattifying Anti-Blemish P Light-Med SALICYLIC ACID GEL TOPICAL 20140425 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .3 mg/30mL 68327-026_2d8c0d42-e15f-4eff-8be0-1d92138ca8d1 68327-026 HUMAN OTC DRUG Cover Fx BB Gel Mattfying Anti-Blemish P Med-Deep SALICYLIC ACID GEL TOPICAL 20140425 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .3 mg/30mL 68327-027_03976463-8cfa-4560-8cc8-42385dd4b6d0 68327-027 HUMAN OTC DRUG Cover Fx BB Gel Mattifying Anti-Blemish G Light-Med SALICYLIC ACID GEL TOPICAL 20140425 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .3 mg/30mL 68327-028_03976463-8cfa-4560-8cc8-42385dd4b6d0 68327-028 HUMAN OTC DRUG Cover Fx BB Gel Mattfying Anti-Blemish G Med-Deep SALICYLIC ACID GEL TOPICAL 20140425 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .3 mg/30mL 68327-029_03976463-8cfa-4560-8cc8-42385dd4b6d0 68327-029 HUMAN OTC DRUG Cover Fx BB Gel Mattifying Anti-Blemish G Deep SALICYLIC ACID GEL TOPICAL 20140425 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .3 mg/30mL 68327-030_182b09b6-7281-4773-8a09-075920f29e3b 68327-030 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer N X-Light SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g 68327-031_182b09b6-7281-4773-8a09-075920f29e3b 68327-031 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer N Light SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g 68327-032_182b09b6-7281-4773-8a09-075920f29e3b 68327-032 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer N Medium SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g 68327-033_182b09b6-7281-4773-8a09-075920f29e3b 68327-033 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer N Med-Deep SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g 68327-034_182b09b6-7281-4773-8a09-075920f29e3b 68327-034 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer N Deep SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g 68327-035_182b09b6-7281-4773-8a09-075920f29e3b 68327-035 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer N X-Deep SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g 68327-036_0da4f19d-d42d-4c8f-8355-8f558dd25840 68327-036 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer G Light SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g 68327-037_0da4f19d-d42d-4c8f-8355-8f558dd25840 68327-037 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer G Medium SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g 68327-038_27dc687d-c9ca-4229-bd9a-58e69596ca60 68327-038 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer P Light SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g 68327-039_27dc687d-c9ca-4229-bd9a-58e69596ca60 68327-039 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer P Medium SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g 68330-001_4e15b344-d5b4-415b-8ce1-a856dc37a13c 68330-001 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080715 ANDA ANDA065294 Cephazone Pharma LLC CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68330-002_4e15b344-d5b4-415b-8ce1-a856dc37a13c 68330-002 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080715 ANDA ANDA065294 Cephazone Pharma LLC CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68330-003_4e15b344-d5b4-415b-8ce1-a856dc37a13c 68330-003 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080715 ANDA ANDA065294 Cephazone Pharma LLC CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68330-004_4e15b344-d5b4-415b-8ce1-a856dc37a13c 68330-004 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080715 ANDA ANDA065294 Cephazone Pharma LLC CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68330-005_4e15b344-d5b4-415b-8ce1-a856dc37a13c 68330-005 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080715 ANDA ANDA065294 Cephazone Pharma LLC CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68330-006_4e15b344-d5b4-415b-8ce1-a856dc37a13c 68330-006 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080715 ANDA ANDA065294 Cephazone Pharma LLC CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68343-001_6f388c5d-a5a4-4e17-8b83-34347b4a3fdf 68343-001 HUMAN OTC DRUG Dermisa Skin Fade Hydroquinone Padimate O CREAM TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part358A Montani Cosmetics Inc HYDROQUINONE; PADIMATE O 2; .6 g/100g; g/100g 68343-002_bdf1a88b-bee3-4fd1-b9e4-46d626599200 68343-002 HUMAN OTC DRUG Dermisa CLEAR SKIN Benzoyl Peroxide CREAM TOPICAL 20130228 OTC MONOGRAPH NOT FINAL part333D Montani Cosmetics Inc BENZOYL PEROXIDE 5 g/100g 68345-100_d73bfd7c-502e-4f10-a0bb-e625deb2b853 68345-100 HUMAN PRESCRIPTION DRUG Repara Silver Nitrate Applicators Silver Nitrate STICK TOPICAL 20121026 UNAPPROVED DRUG OTHER PSS World Medical, Inc. POTASSIUM NITRATE; SILVER NITRATE 25; 75 mg/1; mg/1 68345-270_3ca4e1f1-1204-47e3-95b5-372683c5b71f 68345-270 HUMAN OTC DRUG REPARA Zinc Oxide DRESSING TOPICAL 20100517 OTC MONOGRAPH FINAL part347 PSS World Medical, Inc. ZINC OXIDE 25 g/1 68345-272_1d1142e3-db77-407f-bb28-7c9ecf46f801 68345-272 HUMAN OTC DRUG REPARA Zinc Oxide, Calamine DRESSING TOPICAL 20100517 OTC MONOGRAPH FINAL part347 PSS World Medical, Inc. FERRIC OXIDE RED; ZINC OXIDE; ZINC OXIDE .0195; 1.2805; 25 g/1; g/1; g/1 68345-620_167249b8-6ea3-4429-bb39-ce706cc5a5ae 68345-620 HUMAN OTC DRUG Antimicrobial Antiseptic Hand Wash CHLOROXYLENOL SOAP TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 PSS World Medical, Inc. CHLOROXYLENOL .005 mL/mL 68345-652_b840ef53-f095-4d3d-a4d3-e773d1a5573a 68345-652 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL GEL TOPICAL 20100421 OTC MONOGRAPH NOT FINAL part333 PSS World Medical, Inc. ALCOHOL .62 mL/mL 68345-711_7c00d669-dee7-4d20-8ff3-7b25d39610db 68345-711 HUMAN OTC DRUG Antiseptic Hand Gel with Aloe ALCOHOL GEL TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part333 PSS World Medical, Inc. ALCOHOL 620 mg/g 68345-720_28028226-a6ae-4ca1-9461-2bbd339133c9 68345-720 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part333A PSS World Medical, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 68345-721_28028226-a6ae-4ca1-9461-2bbd339133c9 68345-721 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part333A PSS World Medical, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 68345-814_3ac1ceb7-c80f-48fc-b6a5-a5029c37fb02 68345-814 HUMAN OTC DRUG Select Medical Products Triple Antibiotic BACITRACIN, NEOMYCIN and POLYMYXIN B OINTMENT TOPICAL 20071201 OTC MONOGRAPH FINAL part333B PSS WORLD MEDICAL, INC. BACITRACIN; NEOMYCIN; POLYMYXIN B 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 68345-817_e521695f-36e0-4d1c-a3a0-1347f5104ed6 68345-817 HUMAN OTC DRUG Antifungal Miconazole Nitrate CREAM TOPICAL 20120905 OTC MONOGRAPH FINAL part333C PSS World Medical, Inc. MICONAZOLE NITRATE 20 mg/g 68345-818_1af9e8e1-3f2a-4b9b-93fd-e0588feec24d 68345-818 HUMAN OTC DRUG Repara Lanolin OINTMENT TOPICAL 20140806 OTC MONOGRAPH FINAL part347 PSS World Medical, Inc. LANOLIN 5 g/10g 68345-820_9a511d5b-c719-4a2e-81fb-0cc6c55ad8a6 68345-820 HUMAN OTC DRUG Repara Triple Antibiotic BACITRACIN, NEOMYCIN and POLYMYXIN B OINTMENT TOPICAL 20071201 OTC MONOGRAPH FINAL part333B PSS WORLD MEDICAL, INC. BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 68345-850_7ff937a6-6d51-401c-b4a6-3340aa758a6f 68345-850 HUMAN OTC DRUG EVOKE Antiperspirant and Deodorant Roll-on ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20110615 OTC MONOGRAPH FINAL part350 PSS World Medical ALUMINUM CHLOROHYDRATE 78 mg/mL 68345-852_0eed01c0-bac1-4ed1-90ba-b815a22c1c99 68345-852 HUMAN OTC DRUG EVOKE Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE SPRAY TOPICAL 20110615 OTC MONOGRAPH FINAL part350 PSS World Medical ALUMINUM CHLOROHYDRATE 78 mg/mL 68345-862_8d53ce3d-0651-41cd-a790-1d1be5f7efaf 68345-862 HUMAN OTC DRUG POVIDONE IODINE SWABSTICS ANTISEPTIC GERMICIDE POVIDONE-IODINE SWAB TOPICAL 20100512 OTC MONOGRAPH FINAL part333 PSS World Medical POVIDONE-IODINE 10 1/1001 68345-862_cfc88621-5010-42d0-b7f3-500cfc1b7371 68345-862 HUMAN OTC DRUG POVIDONE IODINE SWABSTICS ANTISEPTIC GERMICIDE POVIDONE-IODINE SWAB TOPICAL 20100512 OTC MONOGRAPH FINAL part333 PSS World Medical POVIDONE-IODINE 10 1/1001 68345-863_ba566fab-596d-4c6d-a462-4fe8aa03b7c0 68345-863 HUMAN OTC DRUG Povidone Iodine Povidone-Iodine SWAB TOPICAL 20120905 OTC MONOGRAPH FINAL part333C PSS World Medical, Inc. POVIDONE-IODINE 100 mg/mL 68345-864_45e00e0f-5c36-4913-be46-1eaf58ca23ec 68345-864 HUMAN OTC DRUG ISOPROPYL ALCOHOL ANTISEPTIC GERMICIDE ISOPROPYL ALCOHOL SWAB TOPICAL 20100503 OTC MONOGRAPH FINAL part333 PSS World Medical ISOPROPYL ALCOHOL .7 1/1 68345-865_0124fdce-8659-41cb-bd51-b8a6a7acf56a 68345-865 HUMAN OTC DRUG Isopropyl Alcohol Swabsticks Isopropyl Alcohol SWAB TOPICAL 20130110 OTC MONOGRAPH FINAL part344 PSS World Medical, Inc. ISOPROPYL ALCOHOL 70 mL/100mL 68345-872_a30b96db-faf9-47ad-9d38-032beea44818 68345-872 HUMAN OTC DRUG Alcohol Prep Pads - Sterile ISOPROPYL ALCOHOL LIQUID TOPICAL 20100603 OTC MONOGRAPH FINAL part333 PSS World Medical ISOPROPYL ALCOHOL 70 g/100g 68345-874_6510f43f-a345-46a6-a8f9-e372863de1a6 68345-874 HUMAN OTC DRUG Alcohol Prep Pads - Non Sterile ISOPROPYL ALCOHOL LIQUID TOPICAL 20100603 OTC MONOGRAPH FINAL part333 PSS World Medical ISOPROPYL ALCOHOL 70 g/100g 68345-876_956c31c4-fad3-4121-9f0a-d3d0d3fd9d80 68345-876 HUMAN OTC DRUG Alcohol Prep Pads Lightweight Non-Sterile ISOPROPYL ALCOHOL LIQUID TOPICAL 20100903 OTC MONOGRAPH FINAL part333A PSS World Medical ISOPROPYL ALCOHOL 70 g/100g 68345-881_1833d872-a7ff-42e0-9923-7aa7730b1d32 68345-881 HUMAN OTC DRUG Obstetrical Antiseptic Towelette BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130619 OTC MONOGRAPH NOT FINAL part333E PSS World Medical, Inc. BENZALKONIUM CHLORIDE .13 g/100g 68345-883_dd2a5290-ea6d-4c5b-9242-0d2a4bad07f0 68345-883 HUMAN OTC DRUG Benzalkonium Chloride Towelette BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130620 OTC MONOGRAPH NOT FINAL part333E PSS World Medical, Inc. BENZALKONIUM CHLORIDE .13 g/100g 68345-908_fb5a8090-ca3a-4a0d-859b-8add23231e07 68345-908 HUMAN OTC DRUG Regimen Ethyl Alcohol GEL TOPICAL 20111102 OTC MONOGRAPH NOT FINAL part333A PSS World Medical, Inc. ALCOHOL 62 mL/100mL 68345-965_df06608b-92b9-4aaf-8b14-70b969abd68c 68345-965 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL GEL TOPICAL 20100421 OTC MONOGRAPH NOT FINAL part333 PSS World Medical, Inc. ALCOHOL .62 mL/mL 68354-131_0528b1bf-f155-5b3d-e054-00144ff88e88 68354-131 HUMAN OTC DRUG ARTREX Camphor, Menthol, and Turpentine CREAM TOPICAL 20040401 OTC MONOGRAPH NOT FINAL part348 Bioved Pharmaceuticals CAMPHOR (NATURAL); MENTHOL; TURPENTINE 3; 1.8; 6 g/60g; g/60g; g/60g 68356-109_02d78902-fd10-499f-a609-9243152be47b 68356-109 HUMAN OTC DRUG POVIDONE-IODINE POVIDONE-IODINE SWAB TOPICAL 20100104 OTC MONOGRAPH FINAL part333 LernaPharm Loris Inc. POVIDONE-IODINE .05 g/1 68356-117_c8839887-5e13-4dae-95b8-64b84516df05 68356-117 HUMAN OTC DRUG ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL SWAB TOPICAL 20100104 OTC MONOGRAPH FINAL part333 LernaPharm Loris Inc. ISOPROPYL ALCOHOL .238 mL/1 68356-119_0c6f2817-5b61-4d07-8789-fc95c1d513df 68356-119 HUMAN OTC DRUG Loris Povidone-Iodine Solution Povidone-Iodine LIQUID TOPICAL 20130416 OTC MONOGRAPH NOT FINAL part333E LernaPharm Loris Inc. POVIDONE-IODINE 1 g/100mL 68356-126_be4a880c-5ad3-4848-81b2-32add237ae51 68356-126 HUMAN OTC DRUG Loris BZK Antiseptic Wipes Benzalkonium Chloride SWAB TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part333A LernaPharm Loris Inc. BENZALKONIUM CHLORIDE .13 g/100g 68368-151_04312f13-b43b-4e5f-a4b3-dd6251fafd33 68368-151 HUMAN OTC DRUG White Glo Professional Choice SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20141203 OTC MONOGRAPH FINAL part355 Barros Laboratories Pty Limited SODIUM MONOFLUOROPHOSPHATE .76 g/100g 68368-152_c6652303-fa2e-4d73-87c5-6799bd9b0e95 68368-152 HUMAN OTC DRUG White Glo Smokers Formula SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20141203 OTC MONOGRAPH FINAL part355 Barros Laboratories Pty Limited SODIUM MONOFLUOROPHOSPHATE .76 g/100g 68368-153_82f0965a-6780-4959-a176-ee32c96c0df2 68368-153 HUMAN OTC DRUG White Glo Coffee Tea Drinkers Formula SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20141203 OTC MONOGRAPH FINAL part355 Barros Laboratories Pty Limited SODIUM MONOFLUOROPHOSPHATE .76 g/100g 68368-154_c1d9c355-07e4-48bc-a357-0e682e1ab709 68368-154 HUMAN OTC DRUG White Glo 2 in 1 with Mouthwash SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20141203 OTC MONOGRAPH FINAL part355 Barros Laboratories Pty Limited SODIUM MONOFLUOROPHOSPHATE .76 g/100g 68382-001_c04e2e1b-7647-4131-b46f-3b53613efe69 68382-001 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Zydus Pharmaceuticals (USA) Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68382-003_d02d7824-4280-4a30-9dd3-734cb80d15c3 68382-003 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20070711 ANDA ANDA077621 Zydus Pharmaceuticals (USA) Inc. AZATHIOPRINE 50 1/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] 68382-004_e17fdd5e-f059-4a9e-8659-3b7f178a26df 68382-004 HUMAN PRESCRIPTION DRUG topiramate topiramate CAPSULE, COATED PELLETS ORAL 20091014 ANDA ANDA078877 Zydus Pharmaceuticals (USA) Inc. TOPIRAMATE 15 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68382-005_e17fdd5e-f059-4a9e-8659-3b7f178a26df 68382-005 HUMAN PRESCRIPTION DRUG topiramate topiramate CAPSULE, COATED PELLETS ORAL 20091014 ANDA ANDA078877 Zydus Pharmaceuticals (USA) Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68382-006_5f1e4fb2-8a36-4ec3-90f9-f93f73e68723 68382-006 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Zydus Pharmaceuticals (USA) Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68382-007_5f1e4fb2-8a36-4ec3-90f9-f93f73e68723 68382-007 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Zydus Pharmaceuticals (USA) Inc. LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68382-008_5f1e4fb2-8a36-4ec3-90f9-f93f73e68723 68382-008 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Zydus Pharmaceuticals (USA) Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68382-009_5f1e4fb2-8a36-4ec3-90f9-f93f73e68723 68382-009 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Zydus Pharmaceuticals (USA) Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68382-010_5f1e4fb2-8a36-4ec3-90f9-f93f73e68723 68382-010 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Zydus Pharmaceuticals (USA) Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68382-011_5f1e4fb2-8a36-4ec3-90f9-f93f73e68723 68382-011 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Zydus Pharmaceuticals (USA) Inc. LAMOTRIGINE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68382-015_bb24a9bb-eb75-4db1-95ec-7d89921e15b8 68382-015 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121110 ANDA ANDA077652 Zydus Pharmaceuticals (USA) Inc. LEVOFLOXACIN 250 mg/1 68382-016_bb24a9bb-eb75-4db1-95ec-7d89921e15b8 68382-016 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121110 ANDA ANDA077652 Zydus Pharmaceuticals (USA) Inc. LEVOFLOXACIN 500 mg/1 68382-017_bb24a9bb-eb75-4db1-95ec-7d89921e15b8 68382-017 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121110 ANDA ANDA077652 Zydus Pharmaceuticals (USA) Inc. LEVOFLOXACIN 750 mg/1 68382-018_de566363-6eed-4877-b796-fbafcf5a6bfa 68382-018 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 Zydus Pharmaceuticals (USA) Inc. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68382-019_de566363-6eed-4877-b796-fbafcf5a6bfa 68382-019 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 Zydus Pharmaceuticals (USA) Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68382-020_de566363-6eed-4877-b796-fbafcf5a6bfa 68382-020 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 Zydus Pharmaceuticals (USA) Inc. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68382-021_de566363-6eed-4877-b796-fbafcf5a6bfa 68382-021 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 Zydus Pharmaceuticals (USA) Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68382-022_67b0aead-e8c8-4799-a9ac-536dfbe89d2b 68382-022 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 Zydus Pharmaceuticals (USA) Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68382-023_67b0aead-e8c8-4799-a9ac-536dfbe89d2b 68382-023 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 Zydus Pharmaceuticals (USA) Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68382-024_67b0aead-e8c8-4799-a9ac-536dfbe89d2b 68382-024 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 Zydus Pharmaceuticals (USA) Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68382-027_aa67d6ec-1ffc-4c90-bfc7-4cdb894e67fc 68382-027 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20050928 ANDA ANDA077060 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68382-028_24abc718-802b-4916-992e-88d0baabc877 68382-028 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100320 ANDA ANDA077064 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68382-028_aa67d6ec-1ffc-4c90-bfc7-4cdb894e67fc 68382-028 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68382-029_24abc718-802b-4916-992e-88d0baabc877 68382-029 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100320 ANDA ANDA077064 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68382-029_aa67d6ec-1ffc-4c90-bfc7-4cdb894e67fc 68382-029 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68382-030_24abc718-802b-4916-992e-88d0baabc877 68382-030 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100320 ANDA ANDA077064 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68382-030_aa67d6ec-1ffc-4c90-bfc7-4cdb894e67fc 68382-030 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68382-031_fba17212-10ca-475a-b432-70fb95603eb0 68382-031 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20100306 ANDA ANDA077100 Zydus Pharmaceuticals (USA) Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68382-032_fba17212-10ca-475a-b432-70fb95603eb0 68382-032 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20100306 ANDA ANDA077100 Zydus Pharmaceuticals (USA) Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68382-033_fba17212-10ca-475a-b432-70fb95603eb0 68382-033 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20100306 ANDA ANDA077100 Zydus Pharmaceuticals (USA) Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68382-034_18744487-e641-4ea6-8782-a5f90af53f7a 68382-034 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 Zydus Pharmaceuticals (USA) Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68382-035_18744487-e641-4ea6-8782-a5f90af53f7a 68382-035 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 Zydus Pharmaceuticals (USA) Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68382-036_18744487-e641-4ea6-8782-a5f90af53f7a 68382-036 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 Zydus Pharmaceuticals (USA) Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68382-039_aa67d6ec-1ffc-4c90-bfc7-4cdb894e67fc 68382-039 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20050928 ANDA ANDA077078 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68382-040_78ba1bcb-7edd-41e3-9df8-5ba9f49aa4e4 68382-040 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Zydus Pharmaceuticals (USA) Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68382-041_78ba1bcb-7edd-41e3-9df8-5ba9f49aa4e4 68382-041 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Zydus Pharmaceuticals (USA) Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68382-042_78ba1bcb-7edd-41e3-9df8-5ba9f49aa4e4 68382-042 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Zydus Pharmaceuticals (USA) Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68382-046_557e22a8-a84d-4aed-a08b-2b7fd6a47276 68382-046 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077094 Zydus Pharmaceuticals (USA) Inc. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 68382-050_7b44082e-a936-4a4b-901f-1f420a4534ad 68382-050 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 Zydus Pharmaceuticals (USA) Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68382-051_7b44082e-a936-4a4b-901f-1f420a4534ad 68382-051 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 Zydus Pharmaceuticals (USA) Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68382-052_dc0932d3-5088-4c7e-a3be-f409be80c8a7 68382-052 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 68382-053_dc0932d3-5088-4c7e-a3be-f409be80c8a7 68382-053 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 68382-054_dc0932d3-5088-4c7e-a3be-f409be80c8a7 68382-054 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 68382-055_dc0932d3-5088-4c7e-a3be-f409be80c8a7 68382-055 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 68382-056_dc0932d3-5088-4c7e-a3be-f409be80c8a7 68382-056 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 68382-057_dc0932d3-5088-4c7e-a3be-f409be80c8a7 68382-057 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 68382-058_dc0932d3-5088-4c7e-a3be-f409be80c8a7 68382-058 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 68382-059_dc0932d3-5088-4c7e-a3be-f409be80c8a7 68382-059 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 68382-064_dc0932d3-5088-4c7e-a3be-f409be80c8a7 68382-064 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] 68382-065_865cdf24-1d5d-454c-959c-7ebad886426a 68382-065 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Zydus Pharmaceuticals (USA) Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68382-066_865cdf24-1d5d-454c-959c-7ebad886426a 68382-066 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Zydus Pharmaceuticals (USA) Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68382-067_865cdf24-1d5d-454c-959c-7ebad886426a 68382-067 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Zydus Pharmaceuticals (USA) Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68382-068_865cdf24-1d5d-454c-959c-7ebad886426a 68382-068 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Zydus Pharmaceuticals (USA) Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68382-069_865cdf24-1d5d-454c-959c-7ebad886426a 68382-069 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Zydus Pharmaceuticals (USA) Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68382-070_39081a42-2c2b-476d-a515-831fc5df5fe3 68382-070 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Zydus Pharmaceuticals (USA) Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68382-071_39081a42-2c2b-476d-a515-831fc5df5fe3 68382-071 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Zydus Pharmaceuticals (USA) Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68382-072_39081a42-2c2b-476d-a515-831fc5df5fe3 68382-072 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Zydus Pharmaceuticals (USA) Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68382-073_39081a42-2c2b-476d-a515-831fc5df5fe3 68382-073 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Zydus Pharmaceuticals (USA) Inc. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68382-077_3cc4a8a5-f457-a9f7-9ff6-a7a8c0c79a2c 68382-077 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20081215 NDA AUTHORIZED GENERIC NDA022224 Zydus Pharmaceuticals USA Inc FENOFIBRIC ACID 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 68382-078_3cc4a8a5-f457-a9f7-9ff6-a7a8c0c79a2c 68382-078 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20081215 NDA AUTHORIZED GENERIC NDA022224 Zydus Pharmaceuticals USA Inc FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] 68382-079_943d342e-5413-40d3-9ecc-3a4691df8061 68382-079 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080103 ANDA ANDA077580 Zydus Pharmaceuticals (USA) Inc. HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 68382-080_943d342e-5413-40d3-9ecc-3a4691df8061 68382-080 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080103 ANDA ANDA077580 Zydus Pharmaceuticals (USA) Inc. HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] 68382-081_943d342e-5413-40d3-9ecc-3a4691df8061 68382-081 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080103 ANDA ANDA077580 Zydus Pharmaceuticals (USA) Inc. HALOPERIDOL 20 mg/1 Typical Antipsychotic [EPC] 68382-092_cfe94fe0-0aec-42ec-8098-9177a0d41001 68382-092 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Zydus Pharmaceuticals (USA) Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68382-093_cfe94fe0-0aec-42ec-8098-9177a0d41001 68382-093 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Zydus Pharmaceuticals (USA) Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68382-094_cfe94fe0-0aec-42ec-8098-9177a0d41001 68382-094 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Zydus Pharmaceuticals (USA) Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68382-095_cfe94fe0-0aec-42ec-8098-9177a0d41001 68382-095 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Zydus Pharmaceuticals (USA) Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68382-096_516307ec-dd56-4abe-bb4c-2ff0e35a1a77 68382-096 HUMAN PRESCRIPTION DRUG Hydroxychloroquine sulfate Hydroxychloroquine sulfate TABLET, FILM COATED ORAL 20080103 ANDA ANDA040657 Zydus Pharmaceuticals (USA) Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC] 68382-097_c04e2e1b-7647-4131-b46f-3b53613efe69 68382-097 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Zydus Pharmaceuticals (USA) Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68382-098_c04e2e1b-7647-4131-b46f-3b53613efe69 68382-098 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Zydus Pharmaceuticals (USA) Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68382-099_c04e2e1b-7647-4131-b46f-3b53613efe69 68382-099 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Zydus Pharmaceuticals (USA) Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68382-101_de566363-6eed-4877-b796-fbafcf5a6bfa 68382-101 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 Zydus Pharmaceuticals (USA) Inc. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68382-106_5350d912-f6ef-4ecb-a7d6-13ec38c62e8f 68382-106 HUMAN PRESCRIPTION DRUG divalproex sodium divalproex sodium CAPSULE, COATED PELLETS ORAL 20090127 ANDA ANDA078919 Zydus Pharmaceuticals (USA) Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68382-108_5f1e4fb2-8a36-4ec3-90f9-f93f73e68723 68382-108 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090123 ANDA ANDA078009 Zydus Pharmaceuticals (USA) Inc. LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68382-109_5f1e4fb2-8a36-4ec3-90f9-f93f73e68723 68382-109 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090123 ANDA ANDA078009 Zydus Pharmaceuticals (USA) Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68382-110_42c0761d-0d0f-4051-9bdd-af8bc6f97f1a 68382-110 HUMAN PRESCRIPTION DRUG Bromocriptine mesylate Bromocriptine mesylate CAPSULE ORAL 20090123 ANDA ANDA078899 Zydus Pharmaceuticals (USA) Inc. BROMOCRIPTINE MESYLATE 5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] 68382-112_e6275072-05b3-4062-af0b-0075a6d86c30 68382-112 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 68382-113_e6275072-05b3-4062-af0b-0075a6d86c30 68382-113 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 68382-114_e6275072-05b3-4062-af0b-0075a6d86c30 68382-114 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 68382-115_e6275072-05b3-4062-af0b-0075a6d86c30 68382-115 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 68382-116_e6275072-05b3-4062-af0b-0075a6d86c30 68382-116 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 68382-117_e6275072-05b3-4062-af0b-0075a6d86c30 68382-117 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 68382-121_e928758b-8452-4a4e-8d0a-76741f9a8d70 68382-121 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070921 ANDA ANDA078226 Zydus Pharmaceuticals (USA) Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68382-122_e928758b-8452-4a4e-8d0a-76741f9a8d70 68382-122 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070921 ANDA ANDA078226 Zydus Pharmaceuticals (USA) Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68382-123_e928758b-8452-4a4e-8d0a-76741f9a8d70 68382-123 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070921 ANDA ANDA078226 Zydus Pharmaceuticals (USA) Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68382-127_557e22a8-a84d-4aed-a08b-2b7fd6a47276 68382-127 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077094 Zydus Pharmaceuticals (USA) Inc. RIBAVIRIN 400 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 68382-128_557e22a8-a84d-4aed-a08b-2b7fd6a47276 68382-128 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077094 Zydus Pharmaceuticals (USA) Inc. RIBAVIRIN 500 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 68382-129_557e22a8-a84d-4aed-a08b-2b7fd6a47276 68382-129 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077094 Zydus Pharmaceuticals (USA) Inc. RIBAVIRIN 600 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 68382-130_f67f2a1b-167a-49c7-bbb1-8f6d5c5b3cdc 68382-130 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20090504 ANDA ANDA065433 Zydus Pharmaceuticals (USA) Inc. MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] 68382-131_f67f2a1b-167a-49c7-bbb1-8f6d5c5b3cdc 68382-131 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET, FILM COATED ORAL 20090504 ANDA ANDA065477 Zydus Pharmaceuticals (USA) Inc. MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] 68382-132_326431ad-543f-461f-83f7-45b9ae22d27f 68382-132 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078225 Zydus Pharmaceuticals (USA) Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68382-133_840260bf-27dd-4de5-93d8-b9d558e595d1 68382-133 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130107 ANDA ANDA078239 Zydus Pharmaceuticals (USA) Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68382-134_840260bf-27dd-4de5-93d8-b9d558e595d1 68382-134 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130107 ANDA ANDA078239 Zydus Pharmaceuticals (USA) Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68382-135_f2879c62-764d-4225-aa53-cede7a9dbae5 68382-135 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Zydus Pharmaceuticals (USA) Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68382-136_f2879c62-764d-4225-aa53-cede7a9dbae5 68382-136 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Zydus Pharmaceuticals (USA) Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68382-137_f2879c62-764d-4225-aa53-cede7a9dbae5 68382-137 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Zydus Pharmaceuticals (USA) Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68382-138_813ee2fe-b982-437f-b3f8-67fb389d71b0 68382-138 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Zydus Pharmaceuticals (USA) Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68382-139_813ee2fe-b982-437f-b3f8-67fb389d71b0 68382-139 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Zydus Pharmaceuticals (USA) Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68382-140_813ee2fe-b982-437f-b3f8-67fb389d71b0 68382-140 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Zydus Pharmaceuticals (USA) Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68382-141_813ee2fe-b982-437f-b3f8-67fb389d71b0 68382-141 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Zydus Pharmaceuticals (USA) Inc. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68382-142_b27a120e-6611-458c-90d5-a69dc71a8bf8 68382-142 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20101004 ANDA ANDA078385 Zydus Pharmaceuticals (USA) Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68382-143_b27a120e-6611-458c-90d5-a69dc71a8bf8 68382-143 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20101004 ANDA ANDA078385 Zydus Pharmaceuticals (USA) Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68382-144_1e1bb78f-8cf9-4f16-b27b-20501bc34aa9 68382-144 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20101120 ANDA ANDA078832 Zydus Pharmaceuticals (USA) Inc. RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68382-145_1e1bb78f-8cf9-4f16-b27b-20501bc34aa9 68382-145 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20101120 ANDA ANDA078832 Zydus Pharmaceuticals (USA) Inc. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68382-146_1e1bb78f-8cf9-4f16-b27b-20501bc34aa9 68382-146 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20101120 ANDA ANDA078832 Zydus Pharmaceuticals (USA) Inc. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68382-147_1e1bb78f-8cf9-4f16-b27b-20501bc34aa9 68382-147 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20101120 ANDA ANDA078832 Zydus Pharmaceuticals (USA) Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68382-154_843c46a0-d820-4f50-afcc-3b91a4c7db57 68382-154 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100629 ANDA ANDA078516 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 68382-155_843c46a0-d820-4f50-afcc-3b91a4c7db57 68382-155 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100629 ANDA ANDA078516 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 68382-156_843c46a0-d820-4f50-afcc-3b91a4c7db57 68382-156 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100629 ANDA ANDA078516 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 68382-161_4dd0a923-1766-4255-9d36-58a65a12cb43 68382-161 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140415 ANDA ANDA090321 Zydus Pharmaceuticals (USA) Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68382-162_4dd0a923-1766-4255-9d36-58a65a12cb43 68382-162 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140415 ANDA ANDA090321 Zydus Pharmaceuticals (USA) Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68382-163_4dd0a923-1766-4255-9d36-58a65a12cb43 68382-163 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140415 ANDA ANDA090321 Zydus Pharmaceuticals (USA) Inc. PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68382-164_4dd0a923-1766-4255-9d36-58a65a12cb43 68382-164 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140415 ANDA ANDA090321 Zydus Pharmaceuticals (USA) Inc. PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68382-177_4cc00eb6-d4a7-4bca-a72e-c19aa17f9811 68382-177 HUMAN PRESCRIPTION DRUG galantamine galantamine TABLET, FILM COATED ORAL 20111010 ANDA ANDA078898 Zydus Pharmaceuticals (USA) Inc. GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68382-178_4cc00eb6-d4a7-4bca-a72e-c19aa17f9811 68382-178 HUMAN PRESCRIPTION DRUG galantamine galantamine TABLET, FILM COATED ORAL 20111010 ANDA ANDA078898 Zydus Pharmaceuticals (USA) Inc. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68382-179_4cc00eb6-d4a7-4bca-a72e-c19aa17f9811 68382-179 HUMAN PRESCRIPTION DRUG galantamine galantamine TABLET, FILM COATED ORAL 20111010 ANDA ANDA078898 Zydus Pharmaceuticals (USA) Inc. GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68382-180_bd3b45eb-1c32-48aa-b2a8-621c96a0282a 68382-180 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Zydus Pharmaceuticals (USA) Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 68382-181_bd3b45eb-1c32-48aa-b2a8-621c96a0282a 68382-181 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Zydus Pharmaceuticals (USA) Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 68382-182_bd3b45eb-1c32-48aa-b2a8-621c96a0282a 68382-182 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Zydus Pharmaceuticals (USA) Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 68382-183_bd3b45eb-1c32-48aa-b2a8-621c96a0282a 68382-183 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Zydus Pharmaceuticals (USA) Inc. BUSPIRONE HYDROCHLORIDE 30 mg/1 68382-187_065490a5-ca9d-4b62-9419-67e72f2bb943 68382-187 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080522 ANDA ANDA040874 Zydus Pharmaceuticals (USA) Inc. DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 68382-188_065490a5-ca9d-4b62-9419-67e72f2bb943 68382-188 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080522 ANDA ANDA040874 Zydus Pharmaceuticals (USA) Inc. DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 68382-189_065490a5-ca9d-4b62-9419-67e72f2bb943 68382-189 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080522 ANDA ANDA040874 Zydus Pharmaceuticals (USA) Inc. DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] 68382-196_190f33ad-d7e1-4b1c-b8d0-b56769bda6b0 68382-196 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100710 ANDA ANDA078920 Zydus Pharmaceuticals (USA) Inc. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68382-197_190f33ad-d7e1-4b1c-b8d0-b56769bda6b0 68382-197 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100710 ANDA ANDA078920 Zydus Pharmaceuticals (USA) Inc. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68382-198_190f33ad-d7e1-4b1c-b8d0-b56769bda6b0 68382-198 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100710 ANDA ANDA078920 Zydus Pharmaceuticals (USA) Inc. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68382-199_190f33ad-d7e1-4b1c-b8d0-b56769bda6b0 68382-199 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100710 ANDA ANDA078920 Zydus Pharmaceuticals (USA) Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68382-200_190f33ad-d7e1-4b1c-b8d0-b56769bda6b0 68382-200 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100710 ANDA ANDA078920 Zydus Pharmaceuticals (USA) Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68382-201_16c1b04a-86e5-385f-c15b-7f0c3ce01454 68382-201 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140630 NDA AUTHORIZED GENERIC NDA020381 Zydus Pharmaceuticals USA Inc NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 68382-202_16c1b04a-86e5-385f-c15b-7f0c3ce01454 68382-202 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140630 NDA AUTHORIZED GENERIC NDA020381 Zydus Pharmaceuticals USA Inc NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 68382-203_16c1b04a-86e5-385f-c15b-7f0c3ce01454 68382-203 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140630 NDA AUTHORIZED GENERIC NDA020381 Zydus Pharmaceuticals USA Inc NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] 68382-204_52480206-22d3-4ea2-a080-f49be7b47277 68382-204 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20121016 ANDA ANDA078926 Zydus Pharmaceuticals (USA) Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68382-205_52480206-22d3-4ea2-a080-f49be7b47277 68382-205 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20121016 ANDA ANDA078926 Zydus Pharmaceuticals (USA) Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68382-209_928f3b9d-2e89-45ad-a108-f9d6f8d4f64f 68382-209 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, COATED ORAL 20100627 ANDA ANDA078921 Zydus Pharmaceuticals (USA) Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 68382-224_af818819-5947-4fd9-8ab6-1255529bfd71 68382-224 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20090706 ANDA ANDA079089 Zydus Pharmaceuticals (USA) Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] 68382-227_2f701839-e0b5-4a1e-8d1e-983a62613073 68382-227 HUMAN PRESCRIPTION DRUG Amiodarone hydrochloride Amiodarone hydrochloride TABLET ORAL 20090810 ANDA ANDA079029 Zydus Pharmaceuticals (USA) Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 68382-228_2e7c10f7-4d4d-34dc-f8e2-efe6667d4857 68382-228 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20041105 NDA AUTHORIZED GENERIC NDA021656 Zydus Pharmaceuticals USA Inc FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68382-230_2e7c10f7-4d4d-34dc-f8e2-efe6667d4857 68382-230 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20041105 NDA AUTHORIZED GENERIC NDA021656 Zydus Pharmaceuticals USA Inc FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68382-247_e2bba53d-1517-4a74-aa5e-67788a3a8874 68382-247 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070904 ANDA ANDA040597 Zydus Pharmaceuticals (USA) Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 68382-248_e2bba53d-1517-4a74-aa5e-67788a3a8874 68382-248 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070904 ANDA ANDA040597 Zydus Pharmaceuticals (USA) Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 68382-260_4a0dce65-f3da-49fa-96d7-bd252ffdc676 68382-260 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin CAPSULE ORAL 20060125 ANDA ANDA077224 Zydus Pharmaceuticals (USA) Inc. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] 68382-261_1684907f-f963-4a77-aff5-2b13b2c71613 68382-261 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide CAPSULE, EXTENDED RELEASE ORAL 20081215 ANDA ANDA040904 Zydus Pharmaceuticals (USA) Inc. ACETAZOLAMIDE 500 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] 68382-266_7ee4f94d-a2b2-ec1c-42cb-cddc5a1a654f 68382-266 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20100614 NDA AUTHORIZED GENERIC NDA021606 Zydus Pharmaceuticals USA Inc PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 68382-267_7ee4f94d-a2b2-ec1c-42cb-cddc5a1a654f 68382-267 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20100614 NDA AUTHORIZED GENERIC NDA021606 Zydus Pharmaceuticals USA Inc PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] 68382-271_cebd2973-f32b-4686-b719-9fd2ca8beba2 68382-271 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140215 ANDA ANDA091134 Zydus Pharmaceuticals (USA) Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68382-272_cebd2973-f32b-4686-b719-9fd2ca8beba2 68382-272 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140215 ANDA ANDA091134 Zydus Pharmaceuticals (USA) Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68382-273_cebd2973-f32b-4686-b719-9fd2ca8beba2 68382-273 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140215 ANDA ANDA091134 Zydus Pharmaceuticals (USA) Inc. ETODOLAC 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68382-302_f40c602a-5eb9-4029-8f64-c3056e04cef0 68382-302 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20110525 ANDA ANDA090100 Zydus Pharmaceuticals (USA) Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68382-303_f40c602a-5eb9-4029-8f64-c3056e04cef0 68382-303 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20110525 ANDA ANDA090100 Zydus Pharmaceuticals (USA) Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68382-314_090b6596-8a11-5342-6274-e6863e5ef081 68382-314 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended-Release Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20000804 NDA AUTHORIZED GENERIC NDA021168 Zydus Pharmaceuticals USA Inc DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68382-315_090b6596-8a11-5342-6274-e6863e5ef081 68382-315 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended-Release Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20130812 NDA AUTHORIZED GENERIC NDA021168 Zydus Pharmaceuticals USA Inc DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68382-319_5829d6f0-fc09-48fc-9ba4-818765e9ff0c 68382-319 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110131 ANDA ANDA090404 Zydus Pharmaceuticals (USA) Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68382-334_db075272-a0bb-4435-86c5-fad790ace35f 68382-334 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET, FILM COATED ORAL 20121015 ANDA ANDA090460 Zydus Pharmaceuticals (USA) Inc. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68382-338_3f97ceb5-e483-4ede-b0d7-2cd20131ccb8 68382-338 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Zydus Pharmaceuticals (USA) Inc. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68382-339_3f97ceb5-e483-4ede-b0d7-2cd20131ccb8 68382-339 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Zydus Pharmaceuticals (USA) Inc. ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68382-340_3f97ceb5-e483-4ede-b0d7-2cd20131ccb8 68382-340 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Zydus Pharmaceuticals (USA) Inc. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68382-341_3f97ceb5-e483-4ede-b0d7-2cd20131ccb8 68382-341 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Zydus Pharmaceuticals (USA) Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68382-342_3f97ceb5-e483-4ede-b0d7-2cd20131ccb8 68382-342 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Zydus Pharmaceuticals (USA) Inc. ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68382-343_3f97ceb5-e483-4ede-b0d7-2cd20131ccb8 68382-343 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Zydus Pharmaceuticals (USA) Inc. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68382-344_3f97ceb5-e483-4ede-b0d7-2cd20131ccb8 68382-344 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Zydus Pharmaceuticals (USA) Inc. ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68382-346_f0698742-1f99-43d7-8bc3-0e499d9d726b 68382-346 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20110511 ANDA ANDA090175 Zydus Pharmaceuticals (USA) Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68382-347_f0698742-1f99-43d7-8bc3-0e499d9d726b 68382-347 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20110511 ANDA ANDA090175 Zydus Pharmaceuticals (USA) Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68382-354_82d9da92-e6c5-4faa-aba5-982ef296fd8b 68382-354 HUMAN PRESCRIPTION DRUG bupropion bupropion TABLET, EXTENDED RELEASE ORAL 20140215 ANDA ANDA201567 Zydus Pharmaceuticals (USA) Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68382-363_a7dfded8-37bd-4d82-afff-2065e6ba24a8 68382-363 HUMAN PRESCRIPTION DRUG letrozole letrozole TABLET, FILM COATED ORAL 20110603 ANDA ANDA090405 Zydus Pharmaceuticals (USA) Inc. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] 68382-385_e078646f-0ba6-4215-b5f2-337f6abb7de8 68382-385 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140527 ANDA ANDA090739 Zydus Pharmaceuticals (USA) Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68382-386_e078646f-0ba6-4215-b5f2-337f6abb7de8 68382-386 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140527 ANDA ANDA090739 Zydus Pharmaceuticals (USA) Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68382-387_e078646f-0ba6-4215-b5f2-337f6abb7de8 68382-387 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140527 ANDA ANDA090739 Zydus Pharmaceuticals (USA) Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68382-398_50e01e7f-651a-f99a-237a-2fa7532721aa 68382-398 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140116 NDA AUTHORIZED GENERIC NDA018279 Zydus Pharmaceuticals USA Inc POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68382-411_f2c559ed-150c-407b-b0a2-e36fd9899d36 68382-411 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20121123 ANDA ANDA091352 Zydus Pharmaceuticals (USA) Inc. OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68382-412_f2c559ed-150c-407b-b0a2-e36fd9899d36 68382-412 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20121123 ANDA ANDA091352 Zydus Pharmaceuticals (USA) Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68382-418_f98fc905-f9bc-4237-b193-e5be2977df46 68382-418 HUMAN OTC DRUG OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED NASAL 20090924 OTC MONOGRAPH NOT FINAL part341 Zydus Pharmaceuticals (USA) Inc. OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL 68382-422_e9a56501-e027-49db-8592-eeba0df04de2 68382-422 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20130301 ANDA ANDA091534 Zydus Pharmaceuticals (USA) Inc. RANITIDINE HYDROCHLORIDE 25 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68382-423_e9a56501-e027-49db-8592-eeba0df04de2 68382-423 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20130301 ANDA ANDA091534 Zydus Pharmaceuticals (USA) Inc. RANITIDINE HYDROCHLORIDE 25 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68382-443_f4d37571-27b3-4d2b-a211-c21491d75718 68382-443 HUMAN PRESCRIPTION DRUG ethosuximide ethosuximide CAPSULE ORAL 20121010 ANDA ANDA200892 Zydus Pharmaceuticals (USA) Inc. ETHOSUXIMIDE 250 1/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68382-444_a8010e10-68fd-455f-968f-d62a1c3e0ffd 68382-444 HUMAN PRESCRIPTION DRUG Famotidine Famotidine POWDER, FOR SUSPENSION ORAL 20100527 ANDA ANDA091020 Zydus Pharmaceuticals USA Inc FAMOTIDINE 40 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68382-471_903da259-32f7-44e9-be7a-c72dd3523fbd 68382-471 HUMAN PRESCRIPTION DRUG telmisartan telmisartan TABLET ORAL 20140827 ANDA ANDA203325 Zydus Pharmaceuticals (USA) Inc. TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68382-472_903da259-32f7-44e9-be7a-c72dd3523fbd 68382-472 HUMAN PRESCRIPTION DRUG telmisartan telmisartan TABLET ORAL 20140827 ANDA ANDA203325 Zydus Pharmaceuticals (USA) Inc. TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68382-473_903da259-32f7-44e9-be7a-c72dd3523fbd 68382-473 HUMAN PRESCRIPTION DRUG telmisartan telmisartan TABLET ORAL 20140827 ANDA ANDA203325 Zydus Pharmaceuticals (USA) Inc. TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68382-500_f2c559ed-150c-407b-b0a2-e36fd9899d36 68382-500 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20121123 ANDA ANDA091352 Zydus Pharmaceuticals (USA) Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68382-520_3e935587-d5e2-47b2-b986-3f0113d19377 68382-520 HUMAN PRESCRIPTION DRUG sirolimus sirolimus TABLET, FILM COATED ORAL 20140115 ANDA ANDA201676 Zydus Pharmaceuticals (USA) Inc. SIROLIMUS .5 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA] 68382-536_df4421ad-772d-46cf-9fe9-c1b58060706a 68382-536 HUMAN PRESCRIPTION DRUG Potassium Citrate Potassium Citrate TABLET, EXTENDED RELEASE ORAL 20140812 ANDA ANDA203546 Zydus Pharmaceuticals (USA) Inc. POTASSIUM CITRATE 5 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 68382-537_df4421ad-772d-46cf-9fe9-c1b58060706a 68382-537 HUMAN PRESCRIPTION DRUG Potassium Citrate Potassium Citrate TABLET, EXTENDED RELEASE ORAL 20140812 ANDA ANDA203546 Zydus Pharmaceuticals (USA) Inc. POTASSIUM CITRATE 10 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 68382-538_df4421ad-772d-46cf-9fe9-c1b58060706a 68382-538 HUMAN PRESCRIPTION DRUG Potassium Citrate Potassium Citrate TABLET, EXTENDED RELEASE ORAL 20140812 ANDA ANDA203546 Zydus Pharmaceuticals (USA) Inc. POTASSIUM CITRATE 15 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 68382-543_7fe8812d-fd51-4360-8dec-79f7b31ff1f2 68382-543 HUMAN PRESCRIPTION DRUG lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20130823 ANDA ANDA202366 Zydus Pharmaceuticals (USA) Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68382-544_7fe8812d-fd51-4360-8dec-79f7b31ff1f2 68382-544 HUMAN PRESCRIPTION DRUG lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20130823 ANDA ANDA202366 Zydus Pharmaceuticals (USA) Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68382-600_50e01e7f-651a-f99a-237a-2fa7532721aa 68382-600 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110222 NDA AUTHORIZED GENERIC NDA018279 Zydus Pharmaceuticals USA Inc POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68382-650_897a0327-25d4-4769-bd6a-0e674264017f 68382-650 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET ORAL 20131219 ANDA ANDA075395 Zydus Pharmaceuticals (USA) Inc. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68382-651_897a0327-25d4-4769-bd6a-0e674264017f 68382-651 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET ORAL 20131219 ANDA ANDA075395 Zydus Pharmaceuticals (USA) Inc. ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68382-652_897a0327-25d4-4769-bd6a-0e674264017f 68382-652 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET ORAL 20131219 ANDA ANDA075395 Zydus Pharmaceuticals (USA) Inc. ISOSORBIDE MONONITRATE 120 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68382-701_085f053d-1010-4dca-ab2b-c1dc68e40beb 68382-701 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20101025 NDA AUTHORIZED GENERIC NDA018238 Zydus Pharmaceuticals (USA) Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68382-702_085f053d-1010-4dca-ab2b-c1dc68e40beb 68382-702 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20101025 NDA AUTHORIZED GENERIC NDA018238 Zydus Pharmaceuticals (USA) Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68382-715_559ee5a7-3897-4a78-859e-d398d3220631 68382-715 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130516 ANDA ANDA202890 Zydus Pharmaceuticals (USA) Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68382-717_559ee5a7-3897-4a78-859e-d398d3220631 68382-717 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130516 ANDA ANDA202890 Zydus Pharmaceuticals (USA) Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68382-758_aa67d6ec-1ffc-4c90-bfc7-4cdb894e67fc 68382-758 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20141209 ANDA ANDA203686 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68382-759_aa67d6ec-1ffc-4c90-bfc7-4cdb894e67fc 68382-759 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20141209 ANDA ANDA203686 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68382-760_aa67d6ec-1ffc-4c90-bfc7-4cdb894e67fc 68382-760 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20141209 ANDA ANDA203686 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68382-761_a16e919f-fd51-a678-693e-9f7c4fb0b6be 68382-761 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 19911031 NDA NDA050662 Zydus Pharmaceuticals USA Inc CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68382-762_a16e919f-fd51-a678-693e-9f7c4fb0b6be 68382-762 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 19911031 NDA NDA050662 Zydus Pharmaceuticals USA Inc CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68382-763_a16e919f-fd51-a678-693e-9f7c4fb0b6be 68382-763 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000303 NDA NDA050775 Zydus Pharmaceuticals USA Inc CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68382-764_a16e919f-fd51-a678-693e-9f7c4fb0b6be 68382-764 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin FOR SUSPENSION ORAL 19911031 NDA NDA050698 Zydus Pharmaceuticals USA Inc CLARITHROMYCIN 125 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68382-765_a16e919f-fd51-a678-693e-9f7c4fb0b6be 68382-765 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin FOR SUSPENSION ORAL 19911031 NDA NDA050698 Zydus Pharmaceuticals USA Inc CLARITHROMYCIN 250 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68382-776_50e01e7f-651a-f99a-237a-2fa7532721aa 68382-776 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140116 NDA AUTHORIZED GENERIC NDA018279 Zydus Pharmaceuticals USA Inc POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68382-791_ee7afbc4-5ccb-4513-94a2-5f8e5406d402 68382-791 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140910 ANDA ANDA204314 Zydus Pharmaceuticals (USA) Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68382-792_ee7afbc4-5ccb-4513-94a2-5f8e5406d402 68382-792 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140910 ANDA ANDA204314 Zydus Pharmaceuticals (USA) Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68382-793_86b99b2c-a270-4390-b386-496fddbb2702 68382-793 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20121226 ANDA ANDA077290 Zydus Pharmaceuticals (USA) Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68382-794_86b99b2c-a270-4390-b386-496fddbb2702 68382-794 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20121226 ANDA ANDA077290 Zydus Pharmaceuticals (USA) Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68382-795_86b99b2c-a270-4390-b386-496fddbb2702 68382-795 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20121226 ANDA ANDA077290 Zydus Pharmaceuticals (USA) Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68382-796_86b99b2c-a270-4390-b386-496fddbb2702 68382-796 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20121226 ANDA ANDA077290 Zydus Pharmaceuticals (USA) Inc. OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68382-797_86b99b2c-a270-4390-b386-496fddbb2702 68382-797 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20121226 ANDA ANDA077290 Zydus Pharmaceuticals (USA) Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68387-100_a347924e-dd03-47c2-84f5-b27f6ec1c494 68387-100 HUMAN PRESCRIPTION DRUG Propoxyphene and Acetaminophen propoxyphene napsylate and acetaminophen TABLET, FILM COATED ORAL 20090301 ANDA ANDA074843 Keltman Pharmaceuticals Inc. ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 650; 100 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68387-106_b09ca9eb-a382-42fb-85bc-ef9ae7105ffb 68387-106 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20100115 ANDA ANDA076615 Keltman Pharmaceuticals Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68387-108_654dcfdc-4012-426e-bcd3-eb21b8e3ce2a 68387-108 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20080625 ANDA ANDA040486 Keltman Pharmaceuticals Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68387-119_6617ac19-8910-4f15-9980-80d3d8628340 68387-119 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20110909 ANDA ANDA077397 Keltman Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68387-130_8eba76b2-3510-40b2-a169-e8c1aea145e1 68387-130 HUMAN PRESCRIPTION DRUG TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET ORAL 20050601 ANDA ANDA076347 Keltman Pharmaceuticals Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68387-140_8eba76b2-3510-40b2-a169-e8c1aea145e1 68387-140 HUMAN PRESCRIPTION DRUG TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET ORAL 20050601 ANDA ANDA076347 Keltman Pharmaceuticals Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68387-165_698b68f2-a474-4a72-a3b4-54bcc4a1d9bb 68387-165 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20101117 ANDA ANDA072192 Keltman Pharmaceuticals Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 68387-166_698b68f2-a474-4a72-a3b4-54bcc4a1d9bb 68387-166 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20101117 ANDA ANDA072193 Keltman Pharmaceuticals Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 68387-170_3bea99e4-ca58-4fb1-b08d-f482b136a5ad 68387-170 HUMAN PRESCRIPTION DRUG Methylprednisolone methylprednisolone TABLET ORAL 20070914 NDA NDA011153 Keltman Pharmaceuticals Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68387-208_a0e7b75d-817b-4584-b5cc-8eeb31fd06f2 68387-208 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20070824 ANDA ANDA078558 Keltman Pharmaceuticals Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68387-210_a0e7b75d-817b-4584-b5cc-8eeb31fd06f2 68387-210 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20070824 ANDA ANDA078558 Keltman Pharmaceuticals Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68387-214_847dce67-5308-4ef6-acb4-e8f54959c743 68387-214 HUMAN OTC DRUG ACETAMINOPHEN Acetaminophen TABLET ORAL 20110101 OTC MONOGRAPH FINAL part343 Keltman Pharmaceuticals Inc. ACETAMINOPHEN 500 mg/1 68387-230_5d819e04-2719-49b2-be5c-f7967563b3fa 68387-230 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100701 ANDA ANDA089699 Keltman Pharmaceuticals Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 68387-235_6baa87dc-cd24-4cc9-8e7d-4bf27484745a 68387-235 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20101117 ANDA ANDA040746 Keltman Pharmaceuticals Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 68387-236_566bd196-3c0c-4f05-9e2e-4803ad3126d4 68387-236 HUMAN PRESCRIPTION DRUG Norco Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20080201 ANDA ANDA040099 Keltman Pharmaceuticals Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 68387-240_8f56731f-733c-4f54-8fb3-296413c22832 68387-240 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20070423 ANDA ANDA083677 Keltman Pharmaceuticals Inc. PREDNISONE 20 mg/1 68387-241_8f56731f-733c-4f54-8fb3-296413c22832 68387-241 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20080707 ANDA ANDA083677 Keltman Pharmaceuticals Inc. PREDNISONE 10 mg/1 68387-250_813e328e-b953-413e-b467-33e71b9211db 68387-250 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 20090319 ANDA ANDA089805 Keltman Pharmaceuticals Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII 68387-260_4b03d85a-0a8d-40e8-b8b1-57184ec19082 68387-260 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20090701 ANDA ANDA077863 Keltman Pharmaceuticals Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68387-310_3c25b886-348e-490c-88ff-b7633a1efcb5 68387-310 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA074467 Keltman Pharmaceuticals Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68387-340_164d7dfa-e10c-4ca9-863a-1837e73b6522 68387-340 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20070725 ANDA ANDA085159 Keltman Pharmaceuticals Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68387-342_164d7dfa-e10c-4ca9-863a-1837e73b6522 68387-342 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20090508 ANDA ANDA085159 Keltman Pharmaceuticals Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68387-345_7e1f7076-7c07-4f46-ba25-9dd18aa47baa 68387-345 HUMAN PRESCRIPTION DRUG Indomethacin extended-release Indomethacin extended-release CAPSULE ORAL 20060109 ANDA ANDA074464 Keltman Pharmaceuticals Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68387-375_5af155d7-3780-435b-9a87-0ce01f1ed6ec 68387-375 HUMAN PRESCRIPTION DRUG Parafon DSC Chlorzoxazone TABLET ORAL 20040620 ANDA ANDA089895 Keltman Pharmaceuticals Inc. CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68387-381_b13ea7d4-6d5a-4dd1-906a-6479480453ab 68387-381 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20110110 ANDA ANDA065095 Keltman Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 100 mg/1 68387-385_43ff2749-e5bb-4baf-8d73-7c56b7cd2eb4 68387-385 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100301 ANDA ANDA076899 Keltman Pharmaceuticals Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 68387-404_5ff43590-6bcd-4b01-8922-ed2089e9ec37 68387-404 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091215 ANDA ANDA078428 Keltman Pharmaceuticals Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68387-410_5ff43590-6bcd-4b01-8922-ed2089e9ec37 68387-410 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091215 ANDA ANDA078428 Keltman Pharmaceuticals Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68387-420_5ff43590-6bcd-4b01-8922-ed2089e9ec37 68387-420 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091215 ANDA ANDA078428 Keltman Pharmaceuticals Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68387-440_2f99c62e-06ed-4e9b-8e53-18d9a85e1e7d 68387-440 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20100420 ANDA ANDA074754 Keltman Pharmaceuticals Inc. KETOROLAC TROMETHAMINE 10 mg/1 68387-450_36c67b60-9529-4f19-a4b8-b68788f836c1 68387-450 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 20070310 ANDA ANDA018578 Keltman Pharmaceuticals Inc. SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 68387-456_9c160477-60c6-4f71-9269-48432b6799f1 68387-456 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20110127 NDA NDA022122 Keltman Pharmaceuticals Inc. DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68387-491_b3fe37b1-8adc-4728-a7c7-9fec050b21ec 68387-491 HUMAN PRESCRIPTION DRUG SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM SOLUTION OPHTHALMIC 20100110 ANDA ANDA089560 Keltman Pharmaceuticals Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 68387-497_daef6ebf-66a8-4909-90e1-20d39ed5ed20 68387-497 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen tramadol hydrochloride and acetaminophen TABLET ORAL 20091019 ANDA ANDA076475 Keltman Pharmaceuticals Inc. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 68387-500_a29e48fd-183b-49af-ba71-7eec24bcd115 68387-500 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20060824 ANDA ANDA071611 Keltman Pharmaceuticals Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68387-502_a29e48fd-183b-49af-ba71-7eec24bcd115 68387-502 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20100610 ANDA ANDA071611 Keltman Pharmaceuticals Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68387-520_d1eae935-c3c2-48fc-8cbd-3e97f62f42fb 68387-520 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine BUTALBITAL AND ACETAMINOPHEN AND CAFFEINE TABLET ORAL 20070829 ANDA ANDA040336 Keltman Pharmaceuticals Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 68387-521_986cbe30-d77a-4ab9-95ba-891b453e6309 68387-521 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20101210 ANDA ANDA076063 Keltman Pharmaceuticals Inc. LISINOPRIL 20 mg/1 68387-531_49cd8e11-2282-4c5b-bb4f-95526a9e2d6b 68387-531 HUMAN PRESCRIPTION DRUG Pentazocine and naloxone PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET ORAL 20090721 ANDA ANDA074736 Keltman Pharmaceuticals Inc. NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE .5; 50 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] 68387-545_f3d225b4-4057-4b9d-b560-d8d3357f9561 68387-545 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20101210 ANDA ANDA078432 Keltman Pharmaceuticals Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68387-550_dacd7084-7ed1-4371-91ea-c797f4636afa 68387-550 HUMAN PRESCRIPTION DRUG Mupirocin mupirocin OINTMENT TOPICAL 20090622 ANDA ANDA065192 Keltman Pharmaceuticals Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 68387-552_8988f2ff-e9e5-47c4-816b-0fc28a599780 68387-552 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 20060301 NDA NDA020998 Keltman Pharmaceuticals Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68387-558_f66fe0dd-f036-43c8-8527-c1384dbd6791 68387-558 HUMAN PRESCRIPTION DRUG Topiramate TOPIRAMATE TABLET ORAL 20100730 ANDA ANDA079162 Keltman Pharmaceuticals Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68387-559_f66fe0dd-f036-43c8-8527-c1384dbd6791 68387-559 HUMAN PRESCRIPTION DRUG Topiramate TOPIRAMATE TABLET ORAL 20100730 ANDA ANDA079162 Keltman Pharmaceuticals Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68387-560_f66fe0dd-f036-43c8-8527-c1384dbd6791 68387-560 HUMAN PRESCRIPTION DRUG Topiramate TOPIRAMATE TABLET ORAL 20100730 ANDA ANDA079162 Keltman Pharmaceuticals Inc. TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68387-600_ec7bacfe-34c8-48a0-b064-fc9367b81150 68387-600 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070810 ANDA ANDA040124 Keltman Pharmaceuticals Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68387-690_1df7b178-a093-4436-81da-a213d1b7cdcd 68387-690 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20070731 ANDA ANDA040527 Keltman Pharmaceuticals Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 68387-695_0a14fdc5-2428-46bf-b6d0-88bac7f9158e 68387-695 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Immediate-Release Diethylpropion hydrochloride TABLET ORAL 20100607 ANDA ANDA011722 Keltman Pharmaceuticals Inc. DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 68387-696_0a14fdc5-2428-46bf-b6d0-88bac7f9158e 68387-696 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 20100607 ANDA ANDA011722 Keltman Pharmaceuticals Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 68387-700_9d3e528b-a748-4bc5-b604-e7e9c5ab9183 68387-700 HUMAN PRESCRIPTION DRUG Feldene Piroxicam CAPSULE ORAL 20070918 ANDA ANDA074131 Keltman Pharmaceuticals Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68387-800_e242ccf8-7339-4a43-82ff-a7b0a6384799 68387-800 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20090427 ANDA ANDA075927 Keltman Pharmaceuticals Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68387-801_e242ccf8-7339-4a43-82ff-a7b0a6384799 68387-801 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20090427 ANDA ANDA075927 Keltman Pharmaceuticals Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68387-802_e242ccf8-7339-4a43-82ff-a7b0a6384799 68387-802 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20101004 ANDA ANDA075927 Keltman Pharmaceuticals Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68387-900_d24bc5c8-18dc-40a6-b54f-7d4e20175950 68387-900 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20090630 ANDA ANDA076003 Keltman Pharmaceuticals Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 68391-029_f669ce7e-8814-44e8-88e1-30f335f88e8f 68391-029 HUMAN OTC DRUG berkley and jensen nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20060119 ANDA ANDA076775 BJWC NICOTINE 2 mg/1 68391-046_dd0dbea7-95e4-406d-a880-d06666f34d31 68391-046 HUMAN OTC DRUG Berkley and Jensen Pain Relief Acetaminophen CAPSULE, GELATIN COATED ORAL 20091223 OTC MONOGRAPH NOT FINAL part343 BJWC ACETAMINOPHEN 500 mg/1 68391-047_9f218892-a9e2-498f-b518-502299e81afd 68391-047 HUMAN OTC DRUG berkley and jensen acid reducer maximum strength Ranitidine TABLET ORAL 20090923 ANDA ANDA078653 BJWC RANITIDINE HYDROCHLORIDE 150 mg/1 68391-050_4308ed13-8996-4ddc-b81c-da7ff7a2f922 68391-050 HUMAN OTC DRUG berkley and jensen ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090427 ANDA ANDA079113 BJWC DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 68391-067_cec26aab-cd87-4c4c-b3f5-6a956aeb9de3 68391-067 HUMAN OTC DRUG Berkley and Jensen Triple Antibiotic bacitracin, neomycin salfate, polymyxin B sulfate OINTMENT TOPICAL 20081216 OTC MONOGRAPH FINAL part333B BJWC BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 68391-094_fb21aac4-35b5-4e44-b27f-4fe4afc78dbf 68391-094 HUMAN OTC DRUG Berkley and Jensen Nasal Decongestant PE Non-Drowsy Maximum Strength Phenylephrine Hydrochloride TABLET ORAL 20090605 OTC MONOGRAPH FINAL part341 BJWC PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 68391-100_5cc6e4f6-c62d-4923-9726-9dbc569a3f49 68391-100 HUMAN OTC DRUG berkley and jensen anti itch Hydrocortisone CREAM TOPICAL 20141209 OTC MONOGRAPH NOT FINAL part348 BJWC HYDROCORTISONE 1 g/100g 68391-110_9a461566-91d5-404b-9875-7d0b04767e11 68391-110 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE ORAL 20130610 OTC MONOGRAPH NOT FINAL part334 BJWC (Berkley & Jensen / BJ's) DOCUSATE SODIUM 100 mg/1 68391-117_be19017a-4e7c-4da9-948a-88a5167c1f8a 68391-117 HUMAN OTC DRUG Berkley and Jensen Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120522 ANDA ANDA202319 BJWC LANSOPRAZOLE 15 mg/1 68391-121_fac5e42a-8d01-4f85-ac6c-cca9a768f5d7 68391-121 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120901 ANDA ANDA202300 BJWC IBUPROFEN 200 mg/1 68391-141_46451256-08fe-4e9e-a0c9-f486368c62c5 68391-141 HUMAN OTC DRUG ANTIBACTERIAL WITH LIGHT MOISTURIZERS TRICLOSAN SOAP TOPICAL 20100723 OTC MONOGRAPH NOT FINAL part333E BJWC TRICLOSAN .115 mL/100mL 68391-149_6111ec2c-0586-4fea-bb17-e510f4c4a17b 68391-149 HUMAN OTC DRUG BERKELEY AND JENSEN ANTIBACTERIAL BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140409 OTC MONOGRAPH NOT FINAL part333E BJWC BENZALKONIUM CHLORIDE .13 mg/mL 68391-150_fc6359ec-d9c4-4111-9234-9e1c26497ca2 68391-150 HUMAN OTC DRUG BERKLEY JENSEN ANTIBACTERIAL HAND BENZALKONIUM CHLORIDE LIQUID TOPICAL 20141209 OTC MONOGRAPH NOT FINAL part333E BJWC BENZALKONIUM CHLORIDE 1.3 mg/mL 68391-161_1c3f6436-ad11-4d98-a8b9-f28ac99c5bfb 68391-161 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130115 OTC MONOGRAPH NOT FINAL part343 BJWC (Berkley & Jensen / BJ's) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 68391-170_48f1e424-0ee3-4791-b0f6-1edb97465716 68391-170 HUMAN OTC DRUG berkley and jensen nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20060118 ANDA ANDA076789 BJWC NICOTINE 4 mg/1 68391-175_c560c5c1-6569-4bb5-8d9d-72a06fbffe17 68391-175 HUMAN OTC DRUG berkley and jensen pain relief Acetaminophen SUSPENSION ORAL 20110128 OTC MONOGRAPH NOT FINAL part343 BJWC ACETAMINOPHEN 160 mg/5mL 68391-194_8fb4f16b-97d4-415c-9401-cf5bc8fd22af 68391-194 HUMAN OTC DRUG berkley and jensen acid controller Famotidine TABLET ORAL 20061108 ANDA ANDA077351 BJWC FAMOTIDINE 20 mg/1 68391-199_0d96cc5c-e262-4866-a3cc-31c565d93dca 68391-199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130515 ANDA ANDA078682 BJWC (Berkley & Jensen / BJ's) IBUPROFEN 200 mg/1 68391-200_b52fc311-8853-4116-941b-8be35456abba 68391-200 HUMAN OTC DRUG Berkley and Jensen Allergy Relief Diphenhydramine Hydrochloride TABLET ORAL 20131210 OTC MONOGRAPH FINAL part341 BJWC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 68391-207_e81d32cb-4512-4b25-8d63-e3335e8e8ecf 68391-207 HUMAN OTC DRUG berkley and jensen triple antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20141030 OTC MONOGRAPH FINAL part333B BJWC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP&apos'U]/g; mg/g; [USP&apos'U]/g 68391-213_fc45ddfa-04c1-4973-a616-9ea496605849 68391-213 HUMAN OTC DRUG Non Aspirin PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130430 OTC MONOGRAPH FINAL part341 BJWC (Berkley & Jensen / BJ's) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 68391-224_dc29a8e9-f916-49d2-b9a6-d2b4537d7b58 68391-224 HUMAN OTC DRUG berkley and jensen anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030419 ANDA ANDA075232 BJWC LOPERAMIDE HYDROCHLORIDE 2 mg/1 68391-227_018c1f57-224e-420b-bc2e-73a68559f5ab 68391-227 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130331 OTC MONOGRAPH FINAL part343 BJWC (Berkley & Jensen / BJ's) ASPIRIN 81 mg/1 68391-238_ab82f447-555d-4359-8d2a-0f8a889d7658 68391-238 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130708 OTC MONOGRAPH NOT FINAL part334 BJWC (Berkley & Jensen / BJ's) DOCUSATE SODIUM 100 mg/1 68391-242_4c0d3b89-d8e2-466f-a1f7-f411cb5b87bc 68391-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131015 OTC MONOGRAPH FINAL part347 BJWC (Berkley & Jensen / BJ's) DIMETHICONE 125 mg/1 68391-267_0e951192-7f44-4d00-81d4-62e4d53eb2c2 68391-267 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110106 OTC MONOGRAPH NOT FINAL part333E BJWC ALCOHOL 65 mL/100mL 68391-267_7fae4a5c-b4f9-4d87-b68a-d3cd323b0d72 68391-267 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110106 OTC MONOGRAPH NOT FINAL part333E BJWC ALCOHOL 65 mL/100mL 68391-300_93c857e4-72b3-433e-ae6f-281cd57e3996 68391-300 HUMAN OTC DRUG berkley and jensen famotidine Famotidine TABLET ORAL 20131209 ANDA ANDA077351 BJWC FAMOTIDINE 20 mg/1 68391-306_cb80c901-7386-4089-b399-a116310da6e2 68391-306 HUMAN OTC DRUG berkley and jensen clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091217 ANDA ANDA090685 BJWC POLYETHYLENE GLYCOL 3350 17 g/17g 68391-314_58359c61-75df-4bdb-aa65-617911663a12 68391-314 HUMAN OTC DRUG Berkley and Jensen Allergy Relief Loratadine TABLET ORAL 20090417 ANDA ANDA076301 BJWC LORATADINE 10 mg/1 68391-319_c16a3898-1093-4df5-a8b0-756c4b293d42 68391-319 HUMAN OTC DRUG Berkley and Jensen Hydrocortisone Hydrocortisone CREAM TOPICAL 20081204 OTC MONOGRAPH NOT FINAL part348 BJWC HYDROCORTISONE 1 g/100g 68391-321_f58a3f75-9962-46ac-a7aa-1a1a1384885c 68391-321 HUMAN OTC DRUG Berkley and Jensen Acid Controller Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20090708 ANDA ANDA077355 BJWC CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE 800; 10; 165 mg/1; mg/1; mg/1 68391-344_d42876ef-b9f8-4660-b274-9180417377ec 68391-344 HUMAN OTC DRUG berkley and jensen nicotine Nicotine Polacrilex LOZENGE ORAL 20060502 ANDA ANDA077007 BJWC NICOTINE 2 mg/1 68391-352_815a7c24-8e2a-4e3f-8127-a59ee4336fd9 68391-352 HUMAN OTC DRUG Berkley and Jensen nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20080921 ANDA ANDA078547 BJWC NICOTINE 2 mg/1 68391-359_e17658e1-d849-48df-8ffb-bfb28d97c2ec 68391-359 HUMAN OTC DRUG berkley and jensen adult tussin dm Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20030419 OTC MONOGRAPH FINAL part341 BJWC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 68391-368_557f5164-934e-4a77-aed1-8317c6676afb 68391-368 HUMAN OTC DRUG Berkley and Jensen Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20070917 ANDA ANDA074661 BJWC NAPROXEN SODIUM 220 mg/1 68391-374_cefc890b-fecd-4b22-bf7e-8d27289990a1 68391-374 HUMAN OTC DRUG berkley and jensen migraine relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20040610 ANDA ANDA075794 BJWC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 68391-416_09b469fe-4aec-4cf5-94aa-c386fb796352 68391-416 HUMAN OTC DRUG Berkley and Jensen Aspirin Aspirin TABLET ORAL 20080723 OTC MONOGRAPH NOT FINAL part343 BJWC ASPIRIN 325 mg/1 68391-456_2cc56d7c-4cbc-44ca-97bd-afba7ae44353 68391-456 HUMAN OTC DRUG berkley and jensen nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070531 ANDA ANDA076777 BJWC NICOTINE 2 mg/1 68391-458_2be5f9a7-3eed-40b3-b39f-ae857c451900 68391-458 HUMAN OTC DRUG Berkley and Jensen Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20090427 ANDA ANDA078336 BJWC CETIRIZINE HYDROCHLORIDE 10 mg/1 68391-479_379d9648-1143-4415-a528-3b18cddcfa9e 68391-479 HUMAN OTC DRUG berkley and jensen allergy Diphenhydramine Hydrochloride TABLET ORAL 20081031 OTC MONOGRAPH FINAL part341 BJWC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 68391-484_02af4491-4d7e-4696-a0cc-a310a30256f3 68391-484 HUMAN OTC DRUG berkley and jensen pain relief extra strength Acetaminophen TABLET ORAL 20060918 OTC MONOGRAPH NOT FINAL part343 BJWC ACETAMINOPHEN 500 mg/1 68391-490_4656a257-c0aa-4f63-af8e-e52a56478557 68391-490 HUMAN OTC DRUG Daytime Nighttime Cold/Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130115 OTC MONOGRAPH FINAL part341 BJWC (Berkley & Jensen / BJ's) 68391-498_8f07cd17-1898-4f03-8b82-a31fe8ec04bc 68391-498 HUMAN OTC DRUG Berkley and Jensen Mucus Relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20141107 ANDA ANDA078912 BJWC GUAIFENESIN 600 mg/1 68391-500_caa22bcb-6617-4724-8dcb-e63bfeef41a9 68391-500 HUMAN OTC DRUG Berkley and Jensen Allergy Relief Cetirizine Hydrochloride TABLET ORAL 20131126 ANDA ANDA078336 BJWC CETIRIZINE HYDROCHLORIDE 10 mg/1 68391-517_5a9e4533-d9ed-49fc-8488-95139e1ae40a 68391-517 HUMAN OTC DRUG berkley and jensen ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090115 ANDA ANDA077349 BJWC IBUPROFEN 200 mg/1 68391-532_ad64c904-3b58-4e67-90bb-cd857e41d3fd 68391-532 HUMAN OTC DRUG berkley and jensen nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070531 ANDA ANDA076779 BJWC NICOTINE 4 mg/1 68391-536_084219c6-b1fc-49e2-bbcd-a9e0881819f4 68391-536 HUMAN OTC DRUG berkley and jensen migraine formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20140221 ANDA ANDA075794 BJWC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 68391-544_f628f60b-1398-47ea-8db8-333fd4292903 68391-544 HUMAN OTC DRUG berkley and jensen acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080428 ANDA ANDA075077 BJWC ACETAMINOPHEN 650 mg/1 68391-550_ad83cde8-345a-4e36-8c32-e25b56f5631d 68391-550 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20130715 OTC MONOGRAPH FINAL part332 BJWC (Berkley & Jensen / BJ's) DIMETHICONE 125 mg/1 68391-571_df68533e-69e8-46e0-95ef-8000ca548dd4 68391-571 HUMAN OTC DRUG Berkley and Jensen Allergy Relief fexofenadine hcl TABLET, FILM COATED ORAL 20110811 ANDA ANDA076447 BJWC FEXOFENADINE HYDROCHLORIDE 180 mg/1 68391-604_2a906c54-75c7-437c-8501-3df04b9c2d54 68391-604 HUMAN OTC DRUG Berkley and Jensen Ibuprofen Ibuprofen TABLET ORAL 20070620 ANDA ANDA072096 BJWC IBUPROFEN 200 mg/1 68391-612_a5c79624-27d3-472d-8d9f-0143f48dfc4b 68391-612 HUMAN OTC DRUG berkley and jensen loratadine non drowsy Loratadine TABLET ORAL 20090417 ANDA ANDA076301 BJWC LORATADINE 10 mg/1 68391-669_4bda0989-5161-49a8-970f-16a30a024eef 68391-669 HUMAN OTC DRUG Berkley and Jensen Arthritis Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140508 ANDA ANDA075077 BJWC ACETAMINOPHEN 650 mg/1 68391-685_e89c34f1-92a2-43cf-8375-8c843a43f69a 68391-685 HUMAN OTC DRUG Berkley and Jensen ibuprofen childrens dye free Ibuprofen LIQUID ORAL 20100107 ANDA ANDA074937 BJWC IBUPROFEN 100 mg/5mL 68391-837_e469f8b1-8c56-4f83-9090-f836d10beb9e 68391-837 HUMAN OTC DRUG Berkley and Jensen Ranitidine Ranitidine TABLET, FILM COATED ORAL 20140701 ANDA ANDA091429 BJWC RANITIDINE HYDROCHLORIDE 150 mg/1 68391-873_f6bfd783-e1ad-4f45-9e36-017d13ced0b5 68391-873 HUMAN OTC DRUG berkley and jensen nicotine polacrilex Nicotine Polacrilex LOZENGE ORAL 20060502 ANDA ANDA077007 BJWC NICOTINE 4 mg/1 68391-915_f1474b3e-0d20-41fd-aa70-f41503ad3b09 68391-915 HUMAN OTC DRUG Berkley and Jensen Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080228 NDA NDA022032 BJWC OMEPRAZOLE 20 mg/1 68391-950_b63b57c4-eaf4-47e1-ba93-5fe2533903d4 68391-950 HUMAN OTC DRUG berkley and jensen acid reducer Ranitidine TABLET, FILM COATED ORAL 20120203 ANDA ANDA091429 BJWC RANITIDINE HYDROCHLORIDE 150 mg/1 68391-974_efc0a9ef-200a-4b1b-843c-cc7e90685871 68391-974 HUMAN OTC DRUG berkley and jensen childrens cetirizine hydrochloride cetirizine hydrochloride LIQUID ORAL 20110513 ANDA ANDA090254 BJWC CETIRIZINE HYDROCHLORIDE 5 mg/5mL 68400-105_82e0ab2f-0e08-4902-a2f4-cf200805799a 68400-105 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-106_55968f18-b6d0-4ad0-8f7c-49307fd54f03 68400-106 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-107_2242a3b6-3b54-498e-9ec0-53690a0606a4 68400-107 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121218 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-108_e825d252-a5ee-4895-bef6-376262f9442b 68400-108 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-109_94339422-ccd9-4fef-8f70-b5d902750073 68400-109 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-110_f3d2ae75-ba9d-41f6-b173-d125973fb6e7 68400-110 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-111_207cec7c-53f6-4709-b57b-ac8792bb28bf 68400-111 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-112_1a1000f1-1629-4576-a912-62c7da89f0d8 68400-112 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130327 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 1.5375 g/125g 68400-113_8bcadb14-32d1-4acb-a1bc-6eb5fa6671ce 68400-113 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130327 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 1.5375 g/125g 68400-114_d8a522e4-b8f6-4565-aa29-64bdd758d715 68400-114 HUMAN PRESCRIPTION DRUG Gelato Neutral pH Sodium Fluoride GEL DENTAL 20130301 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 4.086 g/454g 68400-115_e45830a8-7f1f-486e-b8bd-cf182bec40e9 68400-115 HUMAN PRESCRIPTION DRUG Gelato Neutral pH Sodium Fluoride GEL DENTAL 20130301 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 4.086 g/454g 68400-116_882b853b-0a7e-4542-a36c-3879d66b93dd 68400-116 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130327 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc SODIUM FLUORIDE 1.5375 g/125g 68400-117_79f7f678-04b6-4e96-8811-f604c504abae 68400-117 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130327 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc SODIUM FLUORIDE 1.5375 g/125g 68400-118_1117a2da-e0f2-469d-8b25-eee214012ab4 68400-118 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130327 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 1.5375 g/125g 68400-120_25fe0d6e-63ff-4c64-8a0a-f9d0105ec57f 68400-120 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-121_e24d64a9-b8e2-4e14-84fe-afb7226a0509 68400-121 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-122_9f9e90e1-9f6f-4f64-89dc-e45d39cab525 68400-122 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-134_af2680c7-9e56-42b6-a1c0-22b7570a13e2 68400-134 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130327 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 1.5375 g/125g 68400-135_a995325b-e153-43d5-9e22-508db1a9616d 68400-135 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121218 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-136_d4152902-30a1-4385-aac5-00d3020d3264 68400-136 HUMAN PRESCRIPTION DRUG Gelato Neutral pH Sodium Fluoride GEL DENTAL 20130301 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc SODIUM FLUORIDE 4.086 g/454g 68400-138_202c46b4-9136-4bce-8cee-82718ebb3818 68400-138 HUMAN PRESCRIPTION DRUG Gelato Neutral PH Sodium Fluoride AEROSOL, FOAM DENTAL; ORAL; TOPICAL 20110811 UNAPPROVED DRUG OTHER Deepak Products, inc. SODIUM FLUORIDE 2.5 g/125g 68400-201_6b12195a-7145-4acb-b0f4-48bb4a071904 68400-201 HUMAN OTC DRUG Gelato Homecare Stannous Fluoride GEL DENTAL 20130105 OTC MONOGRAPH FINAL part355 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. STANNOUS FLUORIDE .116 g/120g 68400-202_61a36062-e3c3-4aa2-8c0d-368166090b7d 68400-202 HUMAN PRESCRIPTION DRUG Gelato Perio Maintenance Rinse Stannous Fluoride CONCENTRATE DENTAL 20130201 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. STANNOUS FLUORIDE .34 g/283.5g 68400-203_eb73af5b-9851-446a-a4d0-1e731d6cfd95 68400-203 HUMAN PRESCRIPTION DRUG Hemox A Aluminum Chloride SOLUTION DENTAL 20130115 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. ALUMINUM CHLORIDE 7500 mg/30mL 68400-205_f323d024-6401-4201-8bcd-69dbf2bbb225 68400-205 HUMAN OTC DRUG Gelato Homecare Stannous Fluoride GEL DENTAL 20130105 OTC MONOGRAPH FINAL part355 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. STANNOUS FLUORIDE .116 g/120g 68400-206_4cc89690-63df-4790-9e96-8398b9104211 68400-206 HUMAN PRESCRIPTION DRUG Gelato Perio Maintenance Rinse Stannous Fluoride CONCENTRATE DENTAL 20130201 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. STANNOUS FLUORIDE .34 g/283.5g 68400-207_8b5eca4f-58d1-4904-9f88-f5eeafa2664e 68400-207 HUMAN PRESCRIPTION DRUG Gelato Homecare Vivid Neutral Sodium Fluoride GEL DENTAL 20130315 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE .597 g/120g 68400-208_db210473-199e-47a5-89ac-187e01d68299 68400-208 HUMAN PRESCRIPTION DRUG Gelato Homecare Vivid Neutral Sodium Fluoride GEL DENTAL 20130315 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE .597 g/120g 68400-305_28a6f94a-2279-4776-977a-60498a29f9ef 68400-305 HUMAN PRESCRIPTION DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20121212 20160331 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. BENZOCAINE 6 g/30g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 68400-306_458d5818-617f-48e9-bba1-dae47bea9d6e 68400-306 HUMAN PRESCRIPTION DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20121212 20160228 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. BENZOCAINE 6 g/30g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 68400-307_ca733732-7f49-466c-90af-0d8aeebed354 68400-307 HUMAN PRESCRIPTION DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20121212 20160430 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. BENZOCAINE 6 g/30g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 68400-308_91317f5d-e8da-4f04-8539-1d884f550991 68400-308 HUMAN PRESCRIPTION DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20121212 20160430 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. BENZOCAINE 6 g/30g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 68400-309_c0b67069-6f9d-4417-b929-4bbe8c161b22 68400-309 HUMAN PRESCRIPTION DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20121212 20160630 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. BENZOCAINE 6 g/30g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 68400-310_0a71b1bf-232e-408f-9cc7-2bcd5f498ed1 68400-310 HUMAN PRESCRIPTION DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20121212 20160630 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. BENZOCAINE 6 g/30g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 68400-311_372f4a9d-fb7a-4d22-a356-14265f46b0b2 68400-311 HUMAN PRESCRIPTION DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20121212 20150430 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. BENZOCAINE 6 g/30g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 68400-312_ff461f5a-6226-4284-9704-f0de3310a3dc 68400-312 HUMAN PRESCRIPTION DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20121212 20150531 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. BENZOCAINE 6 g/30g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 68400-316_f5df02ae-3d7c-4945-80e4-bb7b855e6b3a 68400-316 HUMAN PRESCRIPTION DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20121212 20150331 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. BENZOCAINE 6 g/30g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 68400-323_94a574d6-ec2b-42f7-b07c-23e96116b589 68400-323 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine SPRAY, METERED DENTAL 20130729 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 11.4 g/57g 68400-350_08e86fb8-a86b-410d-ac89-9e19e1b3a221 68400-350 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g 68400-351_39815eed-5a98-441a-8280-6f786c50129e 68400-351 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g 68400-352_66be47fc-75ee-4cec-a12e-fdbc20def385 68400-352 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g 68400-353_69f114bf-6497-4dc1-bd46-249f13a37217 68400-353 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g 68400-354_829071e6-abaa-449a-aa3e-40ebb66b48d9 68400-354 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g 68400-355_8ddf8793-00a4-483a-b0ca-d7d21e919965 68400-355 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g 68400-356_2fe53f0a-9d44-40fd-9ce7-4cb77acc3832 68400-356 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g 68400-357_f41baae1-66cc-472a-9c7d-72f8e4b9c410 68400-357 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g 68400-358_4ce86d92-3c00-4a8c-ac87-5691d6752b8e 68400-358 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g 68400-700_c5a808a5-a566-4636-9d9e-f37c6473f16f 68400-700 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-701_d9ca94fc-bed3-481c-9bd6-945fae0f3803 68400-701 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-702_6a67a7a9-a1d1-41c2-a283-cc5d328a931e 68400-702 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-703_d851761a-4183-4359-bc63-bceb0ac7f06c 68400-703 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-704_eebc32c7-db13-4370-8625-99a081f73e3a 68400-704 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-705_5921f8b2-d908-404b-8554-ff29b01b43b0 68400-705 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-706_d409ad68-a47e-4224-88cd-880a91cf3841 68400-706 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-707_6b35e9f7-e488-4a06-b167-bc09d8abf265 68400-707 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-708_d811efe2-3964-4f7d-8304-84e10601fe61 68400-708 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g 68400-800_2d56c92c-cae2-48d6-8cbd-ac2bada8b1aa 68400-800 HUMAN OTC DRUG Sorbet Homecare Stannous Fluoride GEL DENTAL 20130105 OTC MONOGRAPH FINAL part355 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. STANNOUS FLUORIDE .116 g/120g 68400-850_cd13222e-0232-49b2-8119-1620949048c1 68400-850 HUMAN PRESCRIPTION DRUG Sorbet Neutral Sodium Fluoride GEL DENTAL 20130315 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE .597 g/120g 68403-1100_1e18e7a3-5890-45d1-ac79-e44ea37301aa 68403-1100 HUMAN PRESCRIPTION DRUG BabyBIG human botulinum neurotoxin a/b immune globulin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20031023 BLA BLA125034 CALIFORNIA DEPARTMENT OF PUBLIC HEALTH HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN 50 mg/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Bacterial Neurotoxin Neutralization [MoA],Antitoxins [Chemical/Ingredient] 68405-002_e751bc77-460c-4a1e-b29f-a769bbcf92f1 68405-002 HUMAN PRESCRIPTION DRUG Senophylline THEOPHYLLINE ANHYDROUS, CHOLINE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-003_f6b33067-062a-4da6-b5cc-a0ad73a348f2 68405-003 HUMAN PRESCRIPTION DRUG Trazamine TRAZODONE HYDROCHLORIDE, CHOLINE KIT 20110203 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-004_73f4e5b1-cc7c-4d0f-98f4-825964523317 68405-004 HUMAN PRESCRIPTION DRUG Gabitidine RANITIDINE HYDROCHLORIDE, CHOLINE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-007_c68ba550-cc4d-4f27-93bb-37728b417a69 68405-007 HUMAN PRESCRIPTION DRUG Lytensopril-90 LISINOPRIL, ARGININE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-009_b27748be-affb-470d-937e-588b0007dd28 68405-009 HUMAN PRESCRIPTION DRUG Appbutamone-D BUPROPION HYDROCHLORIDE, TYROSINE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-011_c2b824a4-e49b-4e0f-903e-6703a402cbac 68405-011 HUMAN PRESCRIPTION DRUG Appformin METFORMIN HYDROCHLORIDE, TYROSINE KIT 20110207 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-012_da62fe3b-d00c-40df-8904-be0bb152a82f 68405-012 HUMAN PRESCRIPTION DRUG Sentralopram AM-10 CITALOPRAM HYDROBROMIDE, CHOLINE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-013_73930acb-c116-402a-87db-f02222e3ff25 68405-013 HUMAN PRESCRIPTION DRUG Strazepam TEMAZEPAM, CHOLINE KIT 20110215 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-014_794754fb-bcdf-4534-ba9c-f56137e49ef2 68405-014 HUMAN PRESCRIPTION DRUG Gaboxetine FLUOXETINE HYDROCHLORIDE, CHOLINE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-016_ed862e14-d132-44ff-9d91-0d6c01dc3976 68405-016 HUMAN PRESCRIPTION DRUG Trepoxen-250 NAPROXEN,HISTIDINE KIT 20110203 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-017_838ef755-dcea-470d-b304-7c5f54995dc1 68405-017 HUMAN PRESCRIPTION DRUG Hypertensolol METOPROLOL TARTRATE, ARGININE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-018_24300c7f-429f-41d7-9897-824ffb2fafad 68405-018 HUMAN PRESCRIPTION DRUG Theraproxen-90 NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID KIT 20110205 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-019_1c042875-bd4e-49d6-818c-e5a15fa769d7 68405-019 HUMAN PRESCRIPTION DRUG Appformin-D METFORMIN HYDROCHLORIDE, TYROSINE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-021_58c5e8e2-b963-40bd-bf1c-991e0a97b1e2 68405-021 HUMAN PRESCRIPTION DRUG Appbutamone BUPROPION HYDROCHLORIDE, TYROSINE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-022_f4732465-fc71-43ec-9b91-8951a07815a4 68405-022 HUMAN PRESCRIPTION DRUG Sentraflox AM-10 FLUOXETINE HYDROCHLORIDE, CHOLINE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-023_6e82a8c5-4361-48ac-ab68-5b659af80c40 68405-023 HUMAN PRESCRIPTION DRUG Sentrazolpidem PM-5 ZOLPIDEM TARTRATE, CHOLINE KIT ORAL 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-024_c43f32dd-2eef-444b-9451-c5c4b99f1f37 68405-024 HUMAN PRESCRIPTION DRUG Gabazolamine ALPRAZOLAM, CHOLINE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-027_c197ac31-54de-4e62-9483-2b98a40861ce 68405-027 HUMAN PRESCRIPTION DRUG Hypertenevide-12.5 CARVEDILOL, ARGININE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-028_270a6659-91e5-447b-a088-ae1fa26e8353 68405-028 HUMAN PRESCRIPTION DRUG Prazolamine CARISOPRODOL, GABA KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-032_75dadcca-edd3-44a4-a1da-9aca87cf5099 68405-032 HUMAN PRESCRIPTION DRUG Sentrazolam AM ALPRAZOLAM, CHOLINE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-033_2286790f-eda4-4267-9cff-7e0c67f39f6e 68405-033 HUMAN PRESCRIPTION DRUG Sentradine RANITIDINE HYDROCHLORIDE, CHOLINE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-034_2adb76a0-44f1-45cc-98db-352f41f042c5 68405-034 HUMAN PRESCRIPTION DRUG Gabazolamine-0.5 ALPRAZOLAM, CHOLINE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-036_04a69316-b068-48df-8566-192738857d51 68405-036 HUMAN PRESCRIPTION DRUG Trepoxicam-7.5 MELOXICAM, HISTIDINE KIT 20110131 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-037_d53898b9-1426-4954-a7f3-945918a4e46a 68405-037 HUMAN PRESCRIPTION DRUG Hypertenipine AMLODIPINE BESYLATE, ARGININE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-038_373e8770-80e0-45af-acea-e6bcf0283b44 68405-038 HUMAN PRESCRIPTION DRUG Theratramadol-90 TRAMADOL HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID KIT 20110204 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-043_3aa7fe20-ca1e-4fba-a62a-aa7c39c6adbf 68405-043 HUMAN PRESCRIPTION DRUG Sentroxatine FLUOXETINE HYDROCHLORIDE, CHOLINE KIT 20110217 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-044_74ee69ec-2e92-4874-9292-c4a226b15402 68405-044 HUMAN PRESCRIPTION DRUG Gabazolpidem-5 ZOLPIDEM TARTRATE, CHOLINE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-053_eaf2a5be-0223-4e92-b22e-ac05508c61ed 68405-053 HUMAN PRESCRIPTION DRUG Sentravil PM-25 AMITRIPTYLINE HYDROCHLORIDE, CHOLINE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-054_d332a12f-931a-4c0b-9b17-04b60725f689 68405-054 HUMAN PRESCRIPTION DRUG Gabavale-5 DIAZEPAM, CHOLINE KIT 20110507 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-058_b64337aa-e6f2-4a47-9385-570e8a4e23bb 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68405-188_b05ca6d9-8154-47c4-9d34-8c8f91f1f9a3 68405-188 HUMAN PRESCRIPTION DRUG Theraprofen-800 IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID KIT 20110207 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-198_dddfb8cb-9096-4aa6-acc9-b4d071c90341 68405-198 HUMAN PRESCRIPTION DRUG Theracodophen-650 HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID KIT 20110306 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-298_6182ff10-ebf1-406a-8493-d05490a140a6 68405-298 HUMAN PRESCRIPTION DRUG Theracodophen-Low-90 HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID KIT 20110202 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-380_ad239126-e630-4ba1-bc08-8117a4ae0d55 68405-380 HUMAN PRESCRIPTION DRUG Theratramadol-60 TRAMADOL HYDROCHLORIDE, GABA KIT 20110520 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-398_a0141edc-ba7c-4bae-beca-8827f191bec1 68405-398 HUMAN PRESCRIPTION DRUG Theracodeine-300 ACETAMINOPHEN, CODEINE PHOSPHATE, .GAMMA.-AMINOBUTYRIC ACID KIT ORAL 20110215 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-498_22cb359c-06f0-4415-932e-0a64f1c40532 68405-498 HUMAN PRESCRIPTION DRUG Theracodophen-750 HYDROCODONE, ACETAMINOPHEN, .GAMMA.-AMINOBUTYRIC ACID KIT 20110209 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-580_cca43854-d81c-4056-bf54-89f03d20bed7 68405-580 HUMAN PRESCRIPTION DRUG Therabenzaprine-60 CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID KIT 20110515 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-680_9f97326f-9bfc-47dd-bb56-f43028928168 68405-680 HUMAN PRESCRIPTION DRUG Therapentin-60 GABAPENTIN, .GAMMA.-AMINOBUTYRIC ACID KIT 20110517 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68405-880_f9e41972-e777-4562-a16a-034b1eeb4998 68405-880 HUMAN PRESCRIPTION DRUG Theraprofen-60 IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID KIT 20110719 UNAPPROVED DRUG OTHER Physician Therapeutics LLC 68411-4057_ac196ff8-98ae-4e74-a33f-a4fabdd56ca7 68411-4057 HUMAN OTC DRUG Minus-Sol Facial Sun Protection Sunscreen Broad Spectrum SPF 30 Plus White OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120322 OTC MONOGRAPH NOT FINAL part352 Aledian Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4; 2; 5 g/100g; g/100g; g/100g 68411-4058_3367a078-fe41-4de6-9310-35dc25d24e70 68411-4058 HUMAN OTC DRUG Minus-Sol Facial Sun Protection Sunscreen Broad Spectrum SPF 30 Plus Ivory OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120322 OTC MONOGRAPH NOT FINAL part352 Aledian Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4; 5; 5 g/100g; g/100g; g/100g 68419-0001_e5b529a2-46bf-4856-867d-6292b6406c0b 68419-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20031001 UNAPPROVED MEDICAL GAS American Medical Gas LLC OXYGEN 99 L/100L 68421-5100_e5cabec2-8b68-4f0a-b21f-f59d63e8ab88 68421-5100 HUMAN OTC DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SPRAY TOPICAL 20130418 OTC MONOGRAPH NOT FINAL part348 Cintas First Aid & Safety LIDOCAINE HYDROCHLORIDE 20 g/L 68421-5100_fa736b99-c1d8-49e9-8809-4319b2b69ce1 68421-5100 HUMAN OTC DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SPRAY TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 Cintas First Aid & Safety LIDOCAINE HYDROCHLORIDE 20 g/L 68421-5400_64a235b9-fcb1-48ca-a16e-fb094a0a5dab 68421-5400 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SPRAY TOPICAL 20130418 OTC MONOGRAPH NOT FINAL part333A Cintas First Aid & Safety HYDROGEN PEROXIDE 43.275 g/L 68421-5400_77f1c8ee-1c61-4898-985a-e2515716b000 68421-5400 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SPRAY TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part333A Cintas First Aid & Safety HYDROGEN PEROXIDE 43.275 g/L 68421-5500_57a04181-6cff-4425-a2d7-d82c8f5758df 68421-5500 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SPRAY TOPICAL 20130418 OTC MONOGRAPH NOT FINAL part333A Cintas First Aid & Safety ISOPROPYL ALCOHOL 550.2 g/L 68421-5500_c0e8f662-9d1e-4332-8255-699b8740bb7d 68421-5500 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SPRAY TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333A Cintas First Aid & Safety ISOPROPYL ALCOHOL 550.2 g/L 68421-6500_c514a8d6-f62a-4acb-ad42-2df85edb3b7c 68421-6500 HUMAN OTC DRUG First Aid Triple Antibiotic with Pain Reliever bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine OINTMENT TOPICAL 20070330 OTC MONOGRAPH FINAL part333B Cintas First Aid & Safety BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 40; 3.5; 5000 [iU]/g; mg/g; mg/g; [iU]/g 68421-7120_8366774a-a3a7-48c5-85c2-b5d6410f7fdb 68421-7120 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part333E Cintas First Aid & Safety BENZALKONIUM CHLORIDE 1.2478 g/L 68421-7120_95ff0240-ab05-4367-be60-9cdef441634b 68421-7120 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part333E Cintas First Aid & Safety BENZALKONIUM CHLORIDE 1.2478 g/L 68421-8100_8ec8d90f-887b-4538-a31f-2b768e80e9de 68421-8100 HUMAN OTC DRUG Dental Relief benzocaine LIQUID TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part356 Cintas First Aid & Safety BENZOCAINE 200 mg/g 68421-8300_35236268-4230-42ca-8489-8b6d1c1eb448 68421-8300 HUMAN OTC DRUG Itch Relief diphenhydramine hydrochloride LIQUID TOPICAL 20130513 OTC MONOGRAPH NOT FINAL part348 Cintas First Aid & Safety DIPHENHYDRAMINE HYDROCHLORIDE 20.3 g/L 68421-8300_e33cfffd-5e2a-4d76-a9e0-afc05d1f4bf3 68421-8300 HUMAN OTC DRUG Itch Relief diphenhydramine hydrochloride LIQUID TOPICAL 20130513 OTC MONOGRAPH NOT FINAL part348 Cintas First Aid & Safety DIPHENHYDRAMINE HYDROCHLORIDE 20.3 g/L 68428-001_6a1c7e0b-dcaf-4b66-899d-95b042f5ed28 68428-001 HUMAN OTC DRUG Spongatos ACONITUM NAPELLUS - CALCIUM SULFIDE - SPONGIA OFFICINALIS LIQUID ORAL 20100407 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS; CALCIUM SULFIDE; SPONGIA OFFICINALIS SKELETON, ROASTED 3; 12; 3 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL 68428-002_fa04cb05-e71a-4f29-a133-bdb57d23820c 68428-002 HUMAN OTC DRUG Diarrhea ARSENIC TRIOXIDE - CUPRIC ARSENITE - VERATRUM ALBUM ROOT PELLET ORAL 20100812 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIOXIDE; CUPRIC ARSENITE; VERATRUM ALBUM ROOT 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-003_886767c0-3423-472e-bb1c-69b2b362abef 68428-003 HUMAN OTC DRUG Sinus CALCIUM CARBONATE - GOLDENSEAL - POTASSIUM DICHROMATE PELLET ORAL 20100512 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM CARBONATE; GOLDENSEAL; POTASSIUM DICHROMATE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-004_af2dc80f-048a-4dd6-9138-81bd46856b75 68428-004 HUMAN OTC DRUG Stomach Disorders SOLANUM DULCAMARA TOP - ACTIVATED CHARCOAL - CHELONE GLABRA - GOLDENSEAL PELLET ORAL 20100713 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACTIVATED CHARCOAL; CHELONE GLABRA; GOLDENSEAL; SOLANUM DULCAMARA TOP 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-005_1a7ecefb-ec6f-4797-9c72-0a754fbf6fc1 68428-005 HUMAN OTC DRUG Teething TRIBASIC CALCIUM PHOSPHATE - MATRICARIA RECUTITA - ARABICA COFFEE BEAN PELLET ORAL 20100824 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARABICA COFFEE BEAN; MATRICARIA RECUTITA; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-006_f05d7090-1798-40c6-8f5a-ac0e42864195 68428-006 HUMAN OTC DRUG Dry Eyes PULSATILLA VULGARIS - SILICON DIOXIDE - SULFUR PELLET ORAL 20100820 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PULSATILLA VULGARIS; SILICON DIOXIDE; SULFUR 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 68428-007_e4062730-2165-4b2c-8c50-c06fe34f9166 68428-007 HUMAN OTC DRUG Flatulence ASAFETIDA - STRYCHNOS IGNATII SEED - NUTMEG PELLET ORAL 20100713 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ASAFETIDA; NUTMEG; STRYCHNOS IGNATII SEED 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-008_ebe32f39-0c5f-4e4b-90c7-5a93926708cd 68428-008 HUMAN OTC DRUG Flu-like Symptoms ARSENIC TRIIODIDE - EUPATORIUM PERFOLIATUM FLOWERING TOP - GELSEMIUM SEMPERVIRENS ROOT PELLET ORAL 20100623 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIIODIDE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-009_fc073a12-15ee-476a-aecf-da5e11d86e16 68428-009 HUMAN OTC DRUG Fungus GRAPHITE - SEPIA OFFICINALIS JUICE - SULFUR - THUJA OCCIDENTALIS LEAFY TWIG PELLET ORAL 20100707 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GRAPHITE; SEPIA OFFICINALIS JUICE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-010_55bbf799-333d-475a-a105-16339e11b59c 68428-010 HUMAN OTC DRUG Constipation CHILI PEPPER - GOLDENSEAL - CULVERS ROOT - STRYCHNOS NUX-VOMICA SEED - PODOPHYLLUM RESIN PELLET ORAL 20100707 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHILI PEPPER; CULVER'S ROOT; GOLDENSEAL; PODOPHYLLUM RESIN; STRYCHNOS NUX-VOMICA SEED 6; 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-011_20bd63e5-0d0b-4767-a0a9-42d6f5492e7d 68428-011 HUMAN OTC DRUG Hay Fever ONION - ANTHOXANTHUM ODORATUM - SCHOENOCAULON OFFICINALE SEED PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTHOXANTHUM ODORATUM; ONION; SCHOENOCAULON OFFICINALE SEED 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-012_54ad6de2-e240-428b-8986-33a610b3f198 68428-012 HUMAN OTC DRUG Headache Congested CALCIUM FLUORIDE - FERRUM PHOSPHORICUM - SODIUM PHOSPHATE, DIBASIC ANHYDROUS - SODIUM CHLORIDE PELLET ORAL 20100504 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM FLUORIDE; FERRUM PHOSPHORICUM; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC ANHYDROUS 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-013_7c7dadc8-fe87-46c6-b305-76094c348b4c 68428-013 HUMAN OTC DRUG Minor Arthritic Pain APIS MELLIFERA - BLACK COHOSH - CALCIUM FLUORIDE - SODIUM PHOSPHATE, DIBASIC ANHYDROUS - SODIUM CHLORIDE PELLET ORAL 20100707 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products APIS MELLIFERA; BLACK COHOSH; CALCIUM FLUORIDE; SODIUM PHOSPHATE, DIBASIC ANHYDROUS; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-014_50b300b8-8783-4ce2-904a-45dd3820614c 68428-014 HUMAN OTC DRUG Painful Urination BERBERIS VULGARIS ROOT BARK - TURPENTINE - LYCOPODIUM CLAVATUM SPORE PELLET ORAL 20100723 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BERBERIS VULGARIS ROOT BARK; LYCOPODIUM CLAVATUM SPORE; TURPENTINE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-015_48d94187-0ec5-4cef-a403-dbaa3a8265ee 68428-015 HUMAN OTC DRUG Calcarea Phos Kit Refill TRIBASIC CALCIUM PHOSPHATE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TRIBASIC CALCIUM PHOSPHATE 30 [hp_C]/1 68428-016_6fb014e3-db85-412d-aa05-55a42b43eb8d 68428-016 HUMAN OTC DRUG Skin Irritation ARSENIC TRIOXIDE - CALCIUM SULFATE ANHYDROUS - SODIUM PHOSPHATE, DIBASIC ANHYDROUS - SILICON DIOXIDE PELLET ORAL 20100707 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIOXIDE; CALCIUM SULFATE ANHYDROUS; SILICON DIOXIDE; SODIUM PHOSPHATE, DIBASIC ANHYDROUS 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-017_e43c1962-a9a6-41a7-9ccf-93f01e2c3c23 68428-017 HUMAN OTC DRUG Acne ANTIMONY TRISULFIDE - MAHONIA AQUIFOLIUM ROOT BARK - LYCOPODIUM CLAVATUM SPORE PELLET ORAL 20100402 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTIMONY TRISULFIDE; MAHONIA AQUIFOLIUM ROOT BARK; SEPIA OFFICINALIS JUICE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-018_fead19a0-c968-4af5-a60b-49776b6d0951 68428-018 HUMAN OTC DRUG Colds and Cough ACONITUM NAPELLUS - BRYONIA ALBA ROOT - SANGUINARIA CANADENSIS ROOT PELLET ORAL 20100402 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS; BRYONIA ALBA ROOT; SANGUINARIA CANADENSIS ROOT 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-019_4e2d62dd-d0d8-4898-b8b8-49322f336722 68428-019 HUMAN OTC DRUG Head Cold POTASSIUM MERCURIC IODIDE - GELSEMIUM SEMPERVIRENS ROOT - EUPHRASIA STRICTA PELLET ORAL 20100824 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM MERCURIC IODIDE 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 68428-020_38f5b1d2-e322-4ab1-827d-ec5e8518c34f 68428-020 HUMAN OTC DRUG Hot Flashes AMYL NITRITE - LACHESIS MUTA VENOM - SANGUINARIA CANADENSIS ROOT PELLET ORAL 20100402 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMYL NITRITE; LACHESIS MUTA VENOM; SANGUINARIA CANADENSIS ROOT 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-021_a18740cc-8eb8-455a-8c47-601f52bbaeb5 68428-021 HUMAN OTC DRUG Insomnia MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - PASSIFLORA INCARNATA TOP PELLET ORAL 20100402 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARABICA COFFEE BEAN; HYOSCYAMUS NIGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA TOP; STRYCHNOS IGNATII SEED 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 68428-022_c92913a4-153a-43c3-926f-ed63f21fdcdc 68428-022 HUMAN OTC DRUG Low Back Pain BLACK COHOSH - COLCHICUM AUTUMNALE BULB - POTASSIUM IODIDE PELLET ORAL 20100727 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BLACK COHOSH; COLCHICUM AUTUMNALE BULB; POTASSIUM IODIDE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-023_2db0a3bb-9d2a-497f-9d96-4d5d1e766545 68428-023 HUMAN OTC DRUG Headache EPIFAGUS VIRGINIANA - IRIS VERSICOLOR ROOT - POTASSIUM IODIDE PELLET ORAL 20100331 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EPIFAGUS VIRGINIANA; IRIS VERSICOLOR ROOT; STRYCHNOS NUX-VOMICA SEED 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 68428-026_1e705382-f746-4975-ae01-050598befeed 68428-026 HUMAN OTC DRUG Aconitum Napellus Kit Refill ACONITUM NAPELLUS PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS 200 [hp_C]/1 68428-027_3e7d3364-85fd-49ef-85f5-22dbbe073ca8 68428-027 HUMAN OTC DRUG Calcarea Phos Kit Refill TRIBASIC CALCIUM PHOSPHATE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TRIBASIC CALCIUM PHOSPHATE 200 [hp_C]/1 68428-028_22114a37-6ba7-45fb-8573-0e58b88c0368 68428-028 HUMAN OTC DRUG Allium Cepa Kit Refill ONION PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ONION 200 [hp_C]/1 68428-029_adadb1cf-2e75-43e7-aad3-1898c0168136 68428-029 HUMAN OTC DRUG Antimonium Tart Kit Refill ANTIMONY POTASSIUM TARTRATE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTIMONY POTASSIUM TARTRATE 200 [hp_C]/1 68428-030_377342ee-b4a5-4460-84e0-269c9edea610 68428-030 HUMAN OTC DRUG Apis Mellifica Kit Refill APIS MELLIFERA PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products APIS MELLIFERA 200 [hp_C]/1 68428-031_66340c97-3e36-45e3-9141-195fa0bcaa3a 68428-031 HUMAN OTC DRUG Argentum Nitricum Kit Refill SILVER NITRATE PELLET ORAL 20100506 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SILVER NITRATE 200 [hp_C]/1 68428-032_682eadf6-b1af-4f43-afcb-f433e97ad7c6 68428-032 HUMAN OTC DRUG Arnica Montana Kit Refill ARNICA MONTANA PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARNICA MONTANA 200 [hp_C]/1 68428-033_dc3c6ce6-2e60-4fb5-b252-7f1b36ca303e 68428-033 HUMAN OTC DRUG Arsenicum Album Kit Refill ARSENIC TRIOXIDE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIOXIDE 200 [hp_C]/1 68428-034_c7d8f50b-ae08-4fb4-9ce5-30b131535c9c 68428-034 HUMAN OTC DRUG Belladonna Kit Refill ATROPA BELLADONNA PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ATROPA BELLADONNA 200 [hp_C]/1 68428-035_03e644ef-dd28-49dd-bedf-a3875316f1a7 68428-035 HUMAN OTC DRUG Bryonia Alba Kit Refill BRYONIA ALBA ROOT PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BRYONIA ALBA ROOT 200 [hp_C]/1 68428-036_f61e82b2-934a-4585-a1e5-0fa2b1195734 68428-036 HUMAN OTC DRUG Calcarea Carbonica Kit Refill OYSTER SHELL CALCIUM CARBONATE, CRUDE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products OYSTER SHELL CALCIUM CARBONATE, CRUDE 200 [hp_C]/1 68428-037_adbefdd1-7dab-4c53-be4b-2a0b66f93031 68428-037 HUMAN OTC DRUG Calendula Officinalis Kit Refill CALENDULA OFFICINALIS FLOWERING TOP PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALENDULA OFFICINALIS FLOWERING TOP 200 [hp_C]/1 68428-038_b490a49b-f6d1-43fc-bb96-509ef3a38653 68428-038 HUMAN OTC DRUG Cantharis Kit Refill LYTTA VESICATORIA PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LYTTA VESICATORIA 200 [hp_C]/1 68428-039_2bfd4061-71a3-454c-94cb-9e0035187138 68428-039 HUMAN OTC DRUG Carbo Vegetabilis Kit Refill ACTIVATED CHARCOAL PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACTIVATED CHARCOAL 200 [hp_C]/1 68428-040_f1d0a6f7-23b3-414c-8ea0-9f45cfe88c42 68428-040 HUMAN OTC DRUG Caulophyllum Thal Kit Refill CAULOPHYLLUM THALICTROIDES ROOT PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAULOPHYLLUM THALICTROIDES ROOT 200 [hp_C]/1 68428-041_e8cf756d-c44d-45dd-9622-038a9ae8182d 68428-041 HUMAN OTC DRUG Causticum Kit Refill CAUSTICUM PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAUSTICUM 200 [hp_C]/1 68428-042_0600c2fc-ef26-4d52-b668-52f50aceff2c 68428-042 HUMAN OTC DRUG Chamomilla Kit Refill MATRICARIA RECUTITA PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MATRICARIA RECUTITA 200 [hp_C]/1 68428-043_7436eb61-4321-40b5-9a3e-4dd73ed6827e 68428-043 HUMAN OTC DRUG Cinchona Officinalis Kit Refill CINCHONA OFFICINALIS BARK PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CINCHONA OFFICINALIS BARK 200 [hp_C]/1 68428-044_b78487e8-e2fb-48a7-bc06-83ef4b3970f2 68428-044 HUMAN OTC DRUG Cocculus Indicus Kit Refill ANAMIRTA COCCULUS SEED PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANAMIRTA COCCULUS SEED 200 [hp_C]/1 68428-045_f1f89e0d-5eb4-4d28-9d57-0dcf0b354942 68428-045 HUMAN OTC DRUG Coffea Cruda Kit Refill ARABICA COFFEE BEAN PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARABICA COFFEE BEAN 200 [hp_C]/1 68428-046_5f8817c9-71d3-4a55-9f77-7cb97238406a 68428-046 HUMAN OTC DRUG Colocynthis Kit Refill CITRULLUS COLOCYNTHIS FRUIT PULP PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CITRULLUS COLOCYNTHIS FRUIT PULP 200 [hp_C]/1 68428-047_f00a2d3e-ff1a-4471-878a-79cdb4303fe2 68428-047 HUMAN OTC DRUG Euphrasia Officinalis Kit Refill EUPHRASIA STRICTA PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUPHRASIA STRICTA 200 [hp_C]/1 68428-048_c958e7cb-e89f-426f-a74d-425d99ce28e3 68428-048 HUMAN OTC DRUG Ferrum Phos Kit Refill FERRUM PHOSPHORICUM PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERRUM PHOSPHORICUM 200 [hp_C]/1 68428-049_7e954553-fdd5-44cd-a171-2467ba9f2531 68428-049 HUMAN OTC DRUG Gelsemium Semp Kit Refill GELSEMIUM SEMPERVIRENS ROOT PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GELSEMIUM SEMPERVIRENS ROOT 200 [hp_C]/1 68428-050_6658017c-6238-4b1a-9d81-8a512db65667 68428-050 HUMAN OTC DRUG Glonoinum Kit Refill NITROGLYCERIN PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NITROGLYCERIN 200 [hp_C]/1 68428-051_56a82a20-88c6-4a0b-b4f9-6650ac913b7f 68428-051 HUMAN OTC DRUG Hepar Sulph Calc Kit Refill CALCIUM SULFIDE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM SULFIDE 200 [hp_C]/1 68428-052_edc1c2ca-6b9e-47b1-9b54-c3be5e1e6990 68428-052 HUMAN OTC DRUG Hypericum Perf Kit Refill HYPERICUM PERFORATUM PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HYPERICUM PERFORATUM 200 [hp_C]/1 68428-053_1223495c-a192-4b6d-9309-3447247f8cbc 68428-053 HUMAN OTC DRUG Ignatia Amara Kit Refill STRYCHNOS IGNATII SEED PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STRYCHNOS IGNATII SEED 200 [hp_C]/1 68428-054_cadad0ce-b68c-44c0-8b32-7862220f9feb 68428-054 HUMAN OTC DRUG Ipecacuanha Kit Refill IPECAC PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IPECAC 200 [hp_C]/1 68428-055_656feb85-a0e4-4ed8-9c4a-1bfe33f9a594 68428-055 HUMAN OTC DRUG Kali Bichromicum Kit Refill POTASSIUM DICHROMATE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM DICHROMATE 200 [hp_C]/1 68428-056_c7824253-0168-4115-8728-0e760d8b74f4 68428-056 HUMAN OTC DRUG Lachesis Mutus Kit Refill LACHESIS MUTA VENOM PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LACHESIS MUTA VENOM 200 [hp_C]/1 68428-057_d604d029-454c-41fa-98b7-3a3bf1f88250 68428-057 HUMAN OTC DRUG Ledum Palustre Kit Refill LEDUM PALUSTRE TWIG PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LEDUM PALUSTRE TWIG 200 [hp_C]/1 68428-058_f8366a0f-a0d0-4c9b-8877-bbcb8b5e588a 68428-058 HUMAN OTC DRUG Lycopodium Kit Refill LYCOPODIUM CLAVATUM SPORE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LYCOPODIUM CLAVATUM SPORE 200 [hp_C]/1 68428-059_b90b0b19-51cc-402f-b463-c1669bce739d 68428-059 HUMAN OTC DRUG Magnesia Phos Kit Refill MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 200 [hp_C]/1 68428-060_4b00db1c-2cf3-480b-8df7-c6f247a2dda1 68428-060 HUMAN OTC DRUG Mercurius Vivus Kit Refill MERCURY PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MERCURY 200 [hp_C]/1 68428-061_d4459ee3-857c-41bc-9633-99541e27c9d4 68428-061 HUMAN OTC DRUG Natrum Muriaticum Kit Refill SODIUM CHLORIDE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington 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68428-075_4961eb3a-ab2b-4b2e-8882-b9253f74c252 68428-075 HUMAN OTC DRUG Thuja Occidentalis Kit Refill THUJA OCCIDENTALIS LEAFY TWIG PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products THUJA OCCIDENTALIS LEAFY TWIG 200 [hp_C]/1 68428-076_ebc89d54-014b-431a-bef6-cfbcd7a8655e 68428-076 HUMAN OTC DRUG Homeopathic Remedy Kit 200c 50 Remedy Kit PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS; ACTIVATED CHARCOAL; ANAMIRTA COCCULUS SEED; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARABICA COFFEE BEAN; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CAULOPHYLLUM THALICTROIDES ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; EUPHRASIA STRICTA; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; IPECAC; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; MERCURY; NITROGLYCERIN; ONION; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RANCID BEEF; RUTA GRAVEOLENS FLOWERING TOP; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON RADICANS LEAF; TRIBASIC CALCIUM PHOSPHATE 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 68428-077_22024ef2-d355-4790-87e5-788cd62ab7b1 68428-077 HUMAN OTC DRUG Aconitum Napellus Kit Refill ACONITUM NAPELLUS PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS 30 [hp_C]/1 68428-078_1614b7d7-0513-4c52-a100-5ee043495343 68428-078 HUMAN OTC DRUG Allium Cepa Kit Refill ONION PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ONION 30 [hp_C]/1 68428-079_ad912dbb-4ee5-4585-885c-a7513f6ea33c 68428-079 HUMAN OTC DRUG Antimonium Tart Kit Refill ANTIMONY POTASSIUM TARTRATE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTIMONY POTASSIUM TARTRATE 30 [hp_C]/1 68428-080_780564ad-d02d-4b95-84b4-18e0c74c46e4 68428-080 HUMAN OTC DRUG Apis Mellifica Kit Refill APIS MELLIFERA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products APIS MELLIFERA 30 [hp_C]/1 68428-081_03e57823-40ec-4782-8210-d5734d4dbd21 68428-081 HUMAN OTC DRUG Argentum Nitricum Kit Refill SILVER NITRATE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SILVER NITRATE 30 [hp_C]/1 68428-082_c7420322-5259-4187-92d8-6e2b2bc3bdae 68428-082 HUMAN OTC DRUG Arnica Montana Kit Refill ARNICA MONTANA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARNICA MONTANA 30 [hp_C]/1 68428-083_248bd6c3-161f-4ba6-8840-5fa159927929 68428-083 HUMAN OTC DRUG Arsenicum Album Kit Refill ARSENIC TRIOXIDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIOXIDE 30 [hp_C]/1 68428-084_77aa7a3d-ad47-40c4-929e-2c6a6a1f1e8b 68428-084 HUMAN OTC DRUG Belladonna Kit Refill ATROPA BELLADONNA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ATROPA BELLADONNA 30 [hp_C]/1 68428-085_c6067ec0-8a7b-4747-9fa7-d7adfbf0c45a 68428-085 HUMAN OTC DRUG Bryonia Alba Kit Refill BRYONIA ALBA ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BRYONIA ALBA ROOT 30 [hp_C]/1 68428-086_ff91e47d-19df-4a96-8e13-a26a52b42ffe 68428-086 HUMAN OTC DRUG Calcarea Carbonica Kit Refill OYSTER SHELL CALCIUM CARBONATE, CRUDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_C]/1 68428-087_5eb0f134-7f2d-433e-bfc5-57ffb24bde51 68428-087 HUMAN OTC DRUG Calendula Officinalis Kit Refill CALENDULA OFFICINALIS FLOWERING TOP PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALENDULA OFFICINALIS FLOWERING TOP 30 [hp_C]/1 68428-088_d024b578-429e-429f-a8ed-fb9a64c60052 68428-088 HUMAN OTC DRUG Cantharis Kit Refill LYTTA VESICATORIA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LYTTA VESICATORIA 30 [hp_C]/1 68428-089_16916ee1-015e-49e6-b051-66d4eb5431f3 68428-089 HUMAN OTC DRUG Carbo Vegetabilis Kit Refill ACTIVATED CHARCOAL PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACTIVATED CHARCOAL 30 [hp_C]/1 68428-090_ac993e91-e76d-4497-8f82-105437837530 68428-090 HUMAN OTC DRUG Caulophyllum Thal Kit Refill CAULOPHYLLUM THALICTROIDES ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAULOPHYLLUM THALICTROIDES ROOT 30 [hp_C]/1 68428-091_aa37374f-075e-4274-b9ed-80cd1ce5871f 68428-091 HUMAN OTC DRUG Causticum Kit Refill CAUSTICUM PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAUSTICUM 30 [hp_C]/1 68428-092_3ab9a109-eec9-478e-ab81-4b321917f5ee 68428-092 HUMAN OTC DRUG Chamomilla Kit Refill MATRICARIA RECUTITA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MATRICARIA RECUTITA 30 [hp_C]/1 68428-093_28bd4819-dbb5-4657-888a-d15f622fc3db 68428-093 HUMAN OTC DRUG Cinchona Officinalis Kit Refill CINCHONA OFFICINALIS BARK PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CINCHONA OFFICINALIS BARK 30 [hp_C]/1 68428-094_a1e844a6-33a2-4617-b633-cfade5326251 68428-094 HUMAN OTC DRUG Cocculus Indicus Kit Refill ANAMIRTA COCCULUS SEED PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANAMIRTA COCCULUS SEED 30 [hp_C]/1 68428-095_41dffefc-1b72-4546-9958-4982d9a76564 68428-095 HUMAN OTC DRUG Coffea Cruda Kit Refill ARABICA COFFEE BEAN PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARABICA COFFEE BEAN 30 [hp_C]/1 68428-096_86f7e1d4-e1e2-4240-879e-e28d22e814ec 68428-096 HUMAN OTC DRUG Colocynthis Kit Refill CITRULLUS COLOCYNTHIS FRUIT PULP PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CITRULLUS COLOCYNTHIS FRUIT PULP 30 [hp_C]/1 68428-097_7e4cc308-ff8b-4841-961e-98b6c1162029 68428-097 HUMAN OTC DRUG Euphrasia Officinalis Kit Refill EUPHRASIA STRICTA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUPHRASIA STRICTA 30 [hp_C]/1 68428-098_9afb3bb1-17e6-40ad-8bb2-e82c49a094e4 68428-098 HUMAN OTC DRUG Ferrum Phos Kit Refill FERRUM PHOSPHORICUM PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERRUM PHOSPHORICUM 30 [hp_C]/1 68428-099_91a8abe6-27a8-4f12-ab2f-341e7ac105f3 68428-099 HUMAN OTC DRUG Gelsemium Semp Kit Refill GELSEMIUM SEMPERVIRENS ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GELSEMIUM SEMPERVIRENS ROOT 30 [hp_C]/1 68428-100_fc823950-1ce2-4d6e-8c5e-66ab60b919fd 68428-100 HUMAN OTC DRUG Glonoinum Kit Refill NITROGLYCERIN PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NITROGLYCERIN 30 [hp_C]/1 68428-101_e7875e44-1168-4b45-991a-b4bc7d10aedb 68428-101 HUMAN OTC DRUG Hepar Sulph Calc Kit Refill CALCIUM SULFIDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM SULFIDE 30 [hp_C]/1 68428-102_7deb178f-e16b-4b67-9857-ec49c8f2359f 68428-102 HUMAN OTC DRUG Hypericum Perf Kit Refill HYPERICUM PERFORATUM PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HYPERICUM PERFORATUM 30 [hp_C]/1 68428-103_588b727f-c9e9-4ee6-9386-b5b857bef04e 68428-103 HUMAN OTC DRUG Ignatia Amara Kit Refill STRYCHNOS IGNATII SEED PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STRYCHNOS IGNATII SEED 30 [hp_C]/1 68428-104_8e7da391-0115-4730-b4f2-22e23d3b5911 68428-104 HUMAN OTC DRUG Ipecacuanha Kit Refill IPECAC PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IPECAC 30 [hp_C]/1 68428-105_d9f7042f-5d26-4581-8207-9440931ddf7b 68428-105 HUMAN OTC DRUG Kali Bichromicum Kit Refill POTASSIUM DICHROMATE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM DICHROMATE 30 [hp_C]/1 68428-106_f6e60533-306f-445b-8396-d5d9cdf1fa57 68428-106 HUMAN OTC DRUG Lachesis Mutus Kit Refill LACHESIS MUTA VENOM PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LACHESIS MUTA VENOM 30 [hp_C]/1 68428-107_740b001a-dc99-4ec7-9e70-387a7293b8de 68428-107 HUMAN OTC DRUG Ledum Palustre Kit Refill LEDUM PALUSTRE TWIG PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LEDUM PALUSTRE TWIG 30 [hp_C]/1 68428-108_bb3909ad-542a-4273-80e2-761c62acdba0 68428-108 HUMAN OTC DRUG Lycopodium Kit Refill LYCOPODIUM CLAVATUM SPORE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LYCOPODIUM CLAVATUM SPORE 30 [hp_C]/1 68428-109_28309324-4e42-47df-b044-2a24ca8b1b51 68428-109 HUMAN OTC DRUG Magnesia Phos Kit Refill MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 30 [hp_C]/1 68428-110_b713c312-b805-4a25-9046-2c92c57ca10d 68428-110 HUMAN OTC DRUG Mercurius Vivus Kit Refill MERCURY PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MERCURY 300 [hp_C]/1 68428-111_b0b4d774-617a-4e51-bd86-761729619e2d 68428-111 HUMAN OTC DRUG Natrum Muriaticum Kit Refill SODIUM CHLORIDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM CHLORIDE 30 [hp_C]/1 68428-112_268eae26-0b6d-4ae0-9cd2-ab4373c67b3b 68428-112 HUMAN OTC DRUG Nux Vomica Kit Refill STRYCHNOS NUX-VOMICA SEED PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/1 68428-113_9572c7db-e5f4-475f-b117-87180de6eb50 68428-113 HUMAN OTC DRUG Phosphorus Kit Refill PHOSPHORUS PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHOSPHORUS 30 [hp_C]/1 68428-114_1551a077-b68f-4e26-bfd5-c6ebde6e6f12 68428-114 HUMAN OTC DRUG Phytolacca Kit Refill PHYTOLACCA AMERICANA ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHYTOLACCA AMERICANA ROOT 30 [hp_C]/1 68428-115_e5b68a79-a971-428a-b93c-549597656291 68428-115 HUMAN OTC DRUG Pulsatilla Kit Refill PULSATILLA VULGARIS PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PULSATILLA VULGARIS 30 [hp_C]/1 68428-116_6437ec56-eab1-4ae4-a805-6f06e7040167 68428-116 HUMAN OTC DRUG Pyrogenium Kit Refill RANCID BEEF PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RANCID BEEF 30 [hp_C]/1 68428-117_77214e99-210c-4a1d-ba66-35e0b3efb212 68428-117 HUMAN OTC DRUG Rhus Tox Kit Refill TOXICODENDRON RADICANS LEAF PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TOXICODENDRON RADICANS LEAF 30 [hp_C]/1 68428-118_b93af7e0-f611-4af6-9bde-cf53fd5cf8bb 68428-118 HUMAN OTC DRUG Ruta Graveolens Kit Refill RUTA GRAVEOLENS FLOWERING TOP PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RUTA GRAVEOLENS FLOWERING TOP 30 [hp_C]/1 68428-119_0314166a-898e-4994-8a1f-b42ce7832fe0 68428-119 HUMAN OTC DRUG Sepia Kit Refill SEPIA OFFICINALIS JUICE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SEPIA OFFICINALIS JUICE 30 [hp_C]/1 68428-120_1caaf30b-4435-4139-b945-5ce66a88965f 68428-120 HUMAN OTC DRUG Silicea Kit Refill SILICON DIOXIDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SILICON DIOXIDE 30 [hp_C]/1 68428-121_2c00a120-c8b2-424f-be52-c4ceb0dfdef6 68428-121 HUMAN OTC DRUG Spongia Tosta Kit Refill SILICON DIOXIDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SPONGIA OFFICINALIS SKELETON, ROASTED 30 [hp_C]/1 68428-122_b0431e68-b8f4-45fa-81ef-3c7243cf5e8b 68428-122 HUMAN OTC DRUG Staphysagria Kit Refill DELPHINIUM STAPHISAGRIA SEED PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DELPHINIUM STAPHISAGRIA SEED 30 [hp_C]/1 68428-123_ce712653-b393-4016-9cab-d0a1665fe8cd 68428-123 HUMAN OTC DRUG Sulphur Kit Refill SULFUR PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SULFUR 30 [hp_C]/1 68428-124_9423a5a3-2b72-4cbb-a7e3-5be55cd7b5a0 68428-124 HUMAN OTC DRUG Symphytum Off Kit Refill COMFREY ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COMFREY ROOT 30 [hp_C]/1 68428-125_78b304af-a3b4-4358-9902-fe42bf4d259e 68428-125 HUMAN OTC DRUG Thuja Occidentalis Kit Refill THUJA OCCIDENTALIS LEAFY TWIG PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products THUJA OCCIDENTALIS LEAFY TWIG 30 [hp_C]/1 68428-126_a9cf4400-49f0-4aec-813d-f6f8bbc86fb9 68428-126 HUMAN OTC DRUG Homeopathic Remedy Kit 30c 50 Remedy Kit PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS; ACTIVATED CHARCOAL; ANAMIRTA COCCULUS SEED; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARABICA COFFEE BEAN; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CAULOPHYLLUM THALICTROIDES ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; EUPHRASIA STRICTA; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; IPECAC; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; MERCURY; NITROGLYCERIN; ONION; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; RANCID BEEF; RUTA GRAVEOLENS FLOWERING TOP; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON RADICANS LEAF; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 68428-127_572a2853-e558-488c-a083-bb1b566b140b 68428-127 HUMAN OTC DRUG Aesculus Hipp Kit Refill HORSE CHESTNUT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HORSE CHESTNUT 30 [hp_C]/1 68428-128_9dfaf311-714f-4385-a9a3-e1b942cdf18a 68428-128 HUMAN OTC DRUG Agaricus Muscarius Kit Refill AMANITA MUSCARIA VAR. MUSCARIA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMANITA MUSCARIA VAR. MUSCARIA 30 [hp_C]/1 68428-129_df6cb74e-8a9e-4a40-b656-586ef48ee4dd 68428-129 HUMAN OTC DRUG Aloe Socotrina Kit Refill ALOE VERA LEAF PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALOE VERA LEAF 30 [hp_C]/1 68428-130_1f12fd6a-8f5f-4273-96d0-104423aa11db 68428-130 HUMAN OTC DRUG Anacard Orient Kit Refill SEMECARPUS ANACARDIUM JUICE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SEMECARPUS ANACARDIUM JUICE 30 [hp_C]/1 68428-131_bb9e8c04-d80d-43c0-9b83-00a4f8151edd 68428-131 HUMAN OTC DRUG Antimonium Crudum Kit Refill ANTIMONY TRISULFIDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTIMONY TRISULFIDE 30 [hp_C]/1 68428-132_8a61ed1e-9891-47ea-ae1d-5593c7b4b9f1 68428-132 HUMAN OTC DRUG Baptisia Tinctoria Kit Refill BAPTISIA TINCTORIA ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BAPTISIA TINCTORIA ROOT 30 [hp_C]/1 68428-133_a47e6e71-288b-47cc-9cda-c13692fcfbcd 68428-133 HUMAN OTC DRUG Bellis Perennis Kit Refill BELLIS PERENNIS PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BELLIS PERENNIS 30 [hp_C]/1 68428-134_057f73d5-9a64-4583-b778-1a4e28046390 68428-134 HUMAN OTC DRUG Berberis Vulgaris Kit Refill BERBERIS VULGARIS ROOT BARK PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BERBERIS VULGARIS ROOT BARK 30 [hp_C]/1 68428-135_8b5424ef-1543-4423-b827-1196bd8b4b1c 68428-135 HUMAN OTC DRUG Cactus Grandiflorus Kit Refill SELENICEREUS GRANDIFLORUS STEM PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SELENICEREUS GRANDIFLORUS STEM 30 [hp_C]/1 68428-136_caee34f4-52ff-41a4-900d-7a3e45420407 68428-136 HUMAN OTC DRUG Calcarea Fluorica Kit Refill CALCIUM FLUORIDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM FLUORIDE 30 [hp_C]/1 68428-137_9254f34a-622c-4d24-8660-2bd08548c6e6 68428-137 HUMAN OTC DRUG Calcarea Sulphurica Kit Refill CALCIUM SULFATE ANHYDROUS PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM SULFATE ANHYDROUS 30 [hp_C]/1 68428-138_904501c8-b8ff-47d6-90d2-10ea1b2804b1 68428-138 HUMAN OTC DRUG Cimicifuga Racemosa Kit Refill BLACK COHOSH PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BLACK COHOSH 30 [hp_C]/1 68428-139_467dfa8d-6ac1-46ff-a774-77982f673626 68428-139 HUMAN OTC DRUG Conium Maculatum Kit Refill CONIUM MACULATUM FLOWERING TOP PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CONIUM MACULATUM FLOWERING TOP 30 [hp_C]/1 68428-140_218739d8-e513-4914-91dc-47842f780dff 68428-140 HUMAN OTC DRUG Cuprum Metallicum Kit Refill COPPER PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COPPER 30 [hp_C]/1 68428-141_af222bc0-21c4-4079-9124-dd2f0f950d87 68428-141 HUMAN OTC DRUG Digitalis Purpurea Kit Refill DIGITALIS PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DIGITALIS 30 [hp_C]/1 68428-142_d24b4abd-3d2f-4ea9-a6fb-5d9fea0c10f1 68428-142 HUMAN OTC DRUG Drosera Rotundifolia Kit Refill DROSERA ROTUNDIFOLIA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DROSERA ROTUNDIFOLIA 30 [hp_C]/1 68428-143_d9b642ed-33c6-41ec-927a-bd416aa065b7 68428-143 HUMAN OTC DRUG Echinacea Ang Kit Refill ECHINACEA ANGUSTIFOLIA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ECHINACEA ANGUSTIFOLIA 30 [hp_C]/1 68428-144_fafed6e1-d9b6-4725-8324-929cca6b6a98 68428-144 HUMAN OTC DRUG Eupatorium Perf Kit Refill EUPATORIUM PERFOLIATUM FLOWERING TOP PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUPATORIUM PERFOLIATUM FLOWERING TOP 30 [hp_C]/1 68428-145_d0b93c1b-c69d-43f2-b130-4fca9b8b8e5e 68428-145 HUMAN OTC DRUG Graphites Kit Refill GRAPHITE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GRAPHITE 30 [hp_C]/1 68428-146_88e43736-94f0-4304-94dc-8b580e5cd5d0 68428-146 HUMAN OTC DRUG Hamamelis Virginiana Kit Refill HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 30 [hp_C]/1 68428-147_fa42106e-b347-4b59-8d8d-25de437472aa 68428-147 HUMAN OTC DRUG Kali Carbonicum Kit Refill POTASSIUM CARBONATE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM CARBONATE 30 [hp_C]/1 68428-148_6b61ba89-52fe-4c22-9d46-0d7f14007cfe 68428-148 HUMAN OTC DRUG Kali Muriaticum Kit Refill POTASSIUM CHLORIDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM CHLORIDE 30 [hp_C]/1 68428-149_b0303d92-fec5-43b9-a38e-cc699a4c8e16 68428-149 HUMAN OTC DRUG Kali Phosphoricum Kit Refill POTASSIUM PHOSPHATE, DIBASIC PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM PHOSPHATE, DIBASIC 30 [hp_C]/1 68428-150_940a7f7d-7730-4351-a392-4cd9aef2cc85 68428-150 HUMAN OTC DRUG Lac Caninum Kit Refill CANIS LUPUS FAMILIARIS MILK PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CANIS LUPUS FAMILIARIS MILK 30 [hp_C]/1 68428-151_43e77339-10f4-4c4c-8466-45d9dab3fc32 68428-151 HUMAN OTC DRUG Mercurius Corr Kit Refill MERCURIC CHLORIDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MERCURIC CHLORIDE 30 [hp_C]/1 68428-152_0ae717b3-9117-42fc-bcbb-7de533f2088c 68428-152 HUMAN OTC DRUG Natrum Phos Kit Refill SODIUM PHOSPHATE, DIBASIC ANHYDROUS PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM PHOSPHATE, DIBASIC ANHYDROUS 30 [hp_C]/1 68428-153_37f957b3-cdc7-4b39-8efc-27d4a24b14d2 68428-153 HUMAN OTC DRUG Natrum Sulphuricum Kit Refill SODIUM SULFATE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM SULFATE 30 [hp_C]/1 68428-154_f5040d17-fb33-479a-80f0-4fad6f38a6e7 68428-154 HUMAN OTC DRUG Petroleum Kit Refill KEROSENE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products KEROSENE 30 [hp_C]/1 68428-155_2d4e8f5c-d196-42ea-9b10-ca571d36c84c 68428-155 HUMAN OTC DRUG Phosphoricum Acidum Kit Refill PHOSPHORIC ACID PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHOSPHORIC ACID 30 [hp_C]/1 68428-156_3a71eed5-7a5b-493f-b488-739d3fd107da 68428-156 HUMAN OTC DRUG Podophyllum Pelt Kit Refill PODOPHYLLUM PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PODOPHYLLUM 30 [hp_C]/1 68428-157_ae2ff1b0-cb1d-4d4a-8dbe-d7565561c3a5 68428-157 HUMAN OTC DRUG Rumex Crispus Kit Refill RUMEX CRISPUS ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RUMEX CRISPUS ROOT 30 [hp_C]/1 68428-158_93d15d20-8713-4403-a278-b3c47d7dc641 68428-158 HUMAN OTC DRUG Sabadilla Kit Refill SCHOENOCAULON OFFICINALE SEED PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SCHOENOCAULON OFFICINALE SEED 30 [hp_C]/1 68428-159_da0e8294-ba84-4a51-bc98-9779634c95b9 68428-159 HUMAN OTC DRUG Sabina Kit Refill JUNIPERUS SABINA LEAF PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products JUNIPERUS SABINA LEAF 30 [hp_C]/1 68428-160_ad67817e-b4e3-4d77-bb25-95d1b58a2b85 68428-160 HUMAN OTC DRUG Sanguinaria Can Kit Refill SANGUINARIA CANADENSIS ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SANGUINARIA CANADENSIS ROOT 30 [hp_C]/1 68428-161_550bc7b7-9e88-4bc4-a1a1-f7cedfd60ca5 68428-161 HUMAN OTC DRUG Sarsaparilla Kit Refill SARSAPARILLA ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SARSAPARILLA ROOT 30 [hp_C]/1 68428-162_ea39c740-0486-462f-a7c7-b8713c44b41d 68428-162 HUMAN OTC DRUG Secale Cornutum Kit Refill CLAVICEPS PURPUREA SCLEROTIUM PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CLAVICEPS PURPUREA SCLEROTIUM 30 [hp_C]/1 68428-163_32f46255-e72c-4e90-9635-5b720bd0384d 68428-163 HUMAN OTC DRUG Spigelia Anthelmia Kit Refill SPIGELIA ANTHELMIA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SPIGELIA ANTHELMIA 30 [hp_C]/1 68428-164_157fc270-c097-40ee-8dd9-5791f9b6c12a 68428-164 HUMAN OTC DRUG Urtica Urens Kit Refill URTICA URENS PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products URTICA URENS 30 [hp_C]/1 68428-165_7957a8ad-1d8d-425c-92ed-1bf0ad20b85c 68428-165 HUMAN OTC DRUG Valeriana Officinalis Kit Refill VALERIAN PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VALERIAN 30 [hp_C]/1 68428-166_1e92f96a-8b66-4d26-9190-d5b5a08fd4cb 68428-166 HUMAN OTC DRUG Veratrum Album Kit Refill VERATRUM ALBUM ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VERATRUM ALBUM ROOT 30 [hp_C]/1 68428-167_531c43f2-f578-489e-9869-99300d30b634 68428-167 HUMAN OTC DRUG Zincum Metallicum Kit Refill ZINC PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ZINC 30 [hp_C]/1 68428-170_9ab911a4-83eb-45fe-9e57-ec1c5572a396 68428-170 HUMAN OTC DRUG Abelmoschus ABELMOSCHUS MOSCHATUS SEED PELLET ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ABELMOSCHUS MOSCHATUS SEED 30 [hp_C]/1 68428-718_6ed99730-027c-4a48-ae24-ff28f2a172d0 68428-718 HUMAN OTC DRUG Be gone Bruises and Bumps TM ARNICA MONTANA OINTMENT TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARNICA MONTANA 1 [hp_X]/56g 68428-719_46ca6604-96c0-4877-a62d-79ecb01b8500 68428-719 HUMAN OTC DRUG Be gone Cuts and Scrapes TM CALENDULA OFFICINALIS FLOWERING TOP OINTMENT TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/56g 68428-720_bb562395-2e3f-42ea-9778-57b6aecf5a51 68428-720 HUMAN OTC DRUG Be gone Minor Arthritic Pain TM ARNICA MONTANA - RHUS TOXICODENDRON - RUTA GRAVEOLENS OINTMENT TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARNICA MONTANA; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 3; 3; 3 [hp_X]/56g; [hp_X]/56g; [hp_X]/56g 68428-721_1d026dc3-7793-49d7-9d8c-4b5f74e51421 68428-721 HUMAN OTC DRUG Be gone Scars TM THIOSINAMINUM OINTMENT TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALLYLTHIOUREA 2 [hp_X]/56g 68428-722_41335180-694e-46e5-89c1-f1f28b911eba 68428-722 HUMAN OTC DRUG Be gone Warts and Tired Feet TM THUJA OCCIDENTALIS OINTMENT TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products THUJA OCCIDENTALIS LEAFY TWIG 1 [hp_X]/56g 68428-723_8c7e6ea0-25cd-4879-aa50-96c67f7ab4ba 68428-723 HUMAN OTC DRUG Poison Ivy Pills TOXICODENDRON PUBESCENS LEAF PELLET ORAL 20100824 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TOXICODENDRON PUBESCENS LEAF 4 [hp_X]/28g 68428-725_a0ac4ccc-58fb-4929-9cb8-e29b151e9591 68428-725 HUMAN OTC DRUG Be gone Poison Ivy TM TOXICODENDRON PUBESCENS LEAF PELLET ORAL 20130228 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TOXICODENDRON PUBESCENS LEAF 4 [hp_X]/28g 68428-726_217a194b-10c1-4770-aa7d-d6f69984909d 68428-726 HUMAN OTC DRUG Be gone Insomnia MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - STRYCHNOS NUX-VOMICA SEED -PASSIFLORA INCARNATA TOP PELLET ORAL 20130301 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARABICA COFFEE BEAN; HYOSCYAMUS NIGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED 6; 6; 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-727_7a74cf98-a923-42d4-9fc6-9f8cfae9ba9c 68428-727 HUMAN OTC DRUG Be gone SCRATCH-N-ITCH TM GRINDELIA SQUARROSA FLOWERING TOP - CAMPHOR (NATURAL) SPRAY TOPICAL 20121101 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAMPHOR (NATURAL); GRINDELIA SQUARROSA FLOWERING TOP 1; 1 [hp_X]/60mL; [hp_X]/60mL 68428-728_6eb23d33-7787-408d-a0cf-d7f10c08fef3 68428-728 HUMAN OTC DRUG Minor Arthritic Pain APIS MELLIFERA - BLACK COHOSH - CALCIUM FLUORIDE - SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE - TOXICODENDRON PUBESCENS LEAF PELLET ORAL 20130228 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products APIS MELLIFERA; BLACK COHOSH; CALCIUM FLUORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-729_e1a2e5bc-58c6-46e2-80d9-daec62b68d33 68428-729 HUMAN OTC DRUG Be gone Motion Sickness TM ANAMIRTA COCCULUS SEED - STRYCHNOS NUX-VOMICA SEED - KEROSENE PELLET ORAL 20130228 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANAMIRTA COCCULUS SEED; KEROSENE; STRYCHNOS NUX-VOMICA SEED 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-730_dfd2cb6b-0ff4-42d8-8bdd-43e253cc9c6c 68428-730 HUMAN OTC DRUG Be gone Sinus Congestion TM OYSTER SHELL CALCIUM CARBONATE, CRUDE - GOLDENSEAL - POTASSIUM DICHROMATE PELLET ORAL 20130228 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GOLDENSEAL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-731_4de14774-1384-4ee4-89cd-9d42d71e031d 68428-731 HUMAN OTC DRUG Be gone Smoking DIEFFENBACHIA SEGUINE - DAPHNE ODORA BARK - STRYCHNOS NUX-VOMICA SEED - PLANTAGO MAJOR - DELPHINIUM STAPHISAGRIA SEED - TOBACCO LEAF PELLET ORAL 20130301 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; PLANTAGO MAJOR; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 6; 6; 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-732_c847e490-1e2b-42b7-bea2-1b9579cfcfa1 68428-732 HUMAN OTC DRUG Be gone Stomach Disorders TM SOLANUM DULCAMARA TOP - ACTIVATED CHARCOAL - CHELONE GLABRA - GOLDENSEAL PELLET ORAL 20130311 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACTIVATED CHARCOAL; CHELONE GLABRA; GOLDENSEAL; SOLANUM DULCAMARA TOP 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-733_79cf3fcd-3060-4a2d-b150-65db810eea10 68428-733 HUMAN OTC DRUG WHP Be gone Dry Eyes TM PULSATILLA VULGARIS - SILICON DIOXIDE - SULFUR PELLET ORAL 20130716 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PULSATILLA VULGARIS; SILICON DIOXIDE; SULFUR 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-734_32c97fd8-d5ae-40d1-ade3-c787bacd13bb 68428-734 HUMAN OTC DRUG WHP Be gone Flu-like Symptoms TM ARSENIC TRIIODIDE - EUPATORIUM PERFOLIATUM FLOWERING TOP - GELSEMIUM SEMPERVIRENS ROOT PELLET ORAL 20130711 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIIODIDE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-735_d945de83-99c0-4533-82e9-6d48c7c876d0 68428-735 HUMAN OTC DRUG WHP Be gone Hay Fever TM ONION - ANTHOXANTHUM ODORATUM - SCHOENOCAULON OFFICINALE SEED PELLET ORAL 20130722 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTHOXANTHUM ODORATUM; ONION; SCHOENOCAULON OFFICINALE SEED 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-736_8ba71e76-1845-440d-8dbb-74888dba20fc 68428-736 HUMAN OTC DRUG WHP Be gone Fungus TM GRAPHITE - SEPIA OFFICINALIS JUICE - SULFUR - THUJA OCCIDENTALIS LEAFY TWIG PELLET ORAL 20130726 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GRAPHITE; SEPIA OFFICINALIS JUICE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-737_3b03b58a-c73c-4c24-89d2-2a9a641f0372 68428-737 HUMAN OTC DRUG WHP Be gone Hot Flashes TM AMYL NITRITE - LACHESIS MUTA VENOM - SANGUINARIA CANADENSIS ROOT PELLET ORAL 20130708 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMYL NITRITE; LACHESIS MUTA VENOM; SANGUINARIA CANADENSIS ROOT 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-738_b06efeb5-0bd2-4c9b-b234-2b4f6fe124df 68428-738 HUMAN OTC DRUG WHP Be gone Acne TM ANTIMONY TRISULFIDE - MAHONIA AQUIFOLIUM ROOT BARK - LYCOPODIUM CLAVATUM SPORE PELLET ORAL 20130731 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTIMONY TRISULFIDE; MAHONIA AQUIFOLIUM ROOT BARK; SEPIA OFFICINALIS JUICE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-739_ca2c08f0-8bcf-4121-b93d-ee5e37cb6bc9 68428-739 HUMAN OTC DRUG WHP Be gone Low Back Pain TM BLACK COHOSH - COLCHICUM AUTUMNALE BULB - POTASSIUM IODIDE PELLET ORAL 20130904 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BLACK COHOSH; COLCHICUM AUTUMNALE BULB; POTASSIUM IODIDE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-740_8bfb97e8-47d8-4c34-bb96-7bb3a6b74d79 68428-740 HUMAN OTC DRUG WHP Be gone Headache TM EPIFAGUS VIRGINIANA - IRIS VERSICOLOR ROOT - POTASSIUM IODIDE PELLET ORAL 20130904 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EPIFAGUS VIRGINIANA; IRIS VERSICOLOR ROOT; STRYCHNOS NUX-VOMICA SEED 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-741_e23be424-6413-4701-ba90-3874fae895fe 68428-741 HUMAN OTC DRUG WHP Be gone Colds and Cough TM ACONITUM NAPELLUS - BRYONIA ALBA ROOT - SANGUINARIA CANADENSIS ROOT PELLET ORAL 20130909 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS; BRYONIA ALBA ROOT; SANGUINARIA CANADENSIS ROOT 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-742_505372bb-0006-445b-8686-17b57640cade 68428-742 HUMAN OTC DRUG WHP Be gone Head Cold TM POTASSIUM MERCURIC IODIDE - GELSEMIUM SEMPERVIRENS ROOT - EUPHRASIA STRICTA PELLET ORAL 20130909 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM MERCURIC IODIDE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68428-743_66524af2-a051-492f-be18-ae95c062861f 68428-743 HUMAN OTC DRUG WHP Be gone Constipation TM CAPSICUM - GOLDENSEAL - CULVERS ROOT - STRYCHNOS NUX-VOMICA SEED - PODOPHYLLUM RESIN PELLET ORAL 20130910 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAPSICUM; GOLDENSEAL; PODOPHYLLUM RESIN; STRYCHNOS NUX-VOMICA SEED; VERONICASTRUM VIRGINICUM ROOT 6; 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g 68429-201_8988afe9-2661-4826-8039-7cb2d9a4cb50 68429-201 HUMAN OTC DRUG Blue Star Camphor OINTMENT TOPICAL 20121030 OTC MONOGRAPH FINAL part346 GHC Group, LLC CAMPHOR (NATURAL) 12.4 mg/g 68436-110_7c81d5d0-b1f1-401e-b53f-848d2d6b57db 68436-110 HUMAN PRESCRIPTION DRUG Oticin HC Ear Drops Pramoxine HCl / Hydrocortisone / Chloroxylenol SOLUTION/ DROPS AURICULAR (OTIC) 20091112 UNAPPROVED DRUG OTHER Teral, Inc. CHLOROXYLENOL; HYDROCORTISONE; PRAMOXINE HYDROCHLORIDE .01; .1; .01 g/10mL; g/10mL; g/10mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68436-115_76684dbf-5277-4a24-bd0c-80e9719ed71b 68436-115 HUMAN PRESCRIPTION DRUG Oticin Chloroxylenol / Pramoxine HCl SOLUTION/ DROPS AURICULAR (OTIC) 20091112 UNAPPROVED DRUG OTHER Teral, Inc. CHLOROXYLENOL; PRAMOXINE HYDROCHLORIDE .01; .1 g/10mL; g/10mL 68437-010_4d6d0a50-40fe-4366-9f26-331fe901ae4f 68437-010 HUMAN OTC DRUG Sulfur Sulfur OINTMENT TOPICAL 20121201 OTC MONOGRAPH FINAL part333D GRISI Hnos, S.A DE C.V SULFUR 10 g/100g 68437-011_054206cd-c5ee-41c2-a2d8-6cde28fcb08b 68437-011 HUMAN OTC DRUG Sulfur Sulfur SOAP TOPICAL 20121201 OTC MONOGRAPH FINAL part333D GRISI Hnos, S.A DE C.V SULFUR 10 g/100g 68453-170_a795ef75-bee2-4893-8ea7-b4ce9904227e 68453-170 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine CAPSULE ORAL 19981028 ANDA ANDA040261 Victory Pharmaceutical ACETAMINOPHEN; BUTALBITAL; CAFFEINE 500; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 68453-375_0551b032-9385-47cc-975a-2ea941023114 68453-375 HUMAN PRESCRIPTION DRUG NAPRELAN naproxen sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960105 NDA NDA020353 Victory Pharma, Inc. NAPROXEN SODIUM 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68453-777_0551b032-9385-47cc-975a-2ea941023114 68453-777 HUMAN PRESCRIPTION DRUG NAPRELAN naproxen sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081219 NDA NDA020353 Victory Pharma, Inc. NAPROXEN SODIUM 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68453-850_0551b032-9385-47cc-975a-2ea941023114 68453-850 HUMAN PRESCRIPTION DRUG NAPRELAN naproxen sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960105 NDA NDA020353 Victory Pharma, Inc. NAPROXEN SODIUM 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68453-900_0551b032-9385-47cc-975a-2ea941023114 68453-900 HUMAN PRESCRIPTION DRUG NAPRELAN naproxen sodium KIT ORAL 20091015 NDA NDA020353 Victory Pharma, Inc. 68453-950_3c79395e-abe2-4cec-8bd3-b9a6bdfec7d9 68453-950 HUMAN PRESCRIPTION DRUG Fexmid cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20081101 ANDA ANDA071611 Victory Pharma, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68462-101_2f2101c8-be50-44d9-9800-26210fb15fda 68462-101 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Glenmark Generics Inc., USA FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68462-102_2f2101c8-be50-44d9-9800-26210fb15fda 68462-102 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Glenmark Generics Inc., USA FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68462-103_2f2101c8-be50-44d9-9800-26210fb15fda 68462-103 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Glenmark Generics Inc., USA FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68462-104_2f2101c8-be50-44d9-9800-26210fb15fda 68462-104 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Glenmark Generics Inc., USA FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68462-105_f0f58f56-d258-4ddb-b402-a38dbfdfbf1c 68462-105 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077535 Glenmark Generics Inc., USA ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68462-106_f0f58f56-d258-4ddb-b402-a38dbfdfbf1c 68462-106 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077535 Glenmark Generics Inc., USA ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68462-107_f0f58f56-d258-4ddb-b402-a38dbfdfbf1c 68462-107 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077535 Glenmark Generics Inc., USA ONDANSETRON HYDROCHLORIDE 24 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68462-108_ce67c4b8-6c95-4ab3-b170-c268c3b90d20 68462-108 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Glenmark Generics Inc., USA TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68462-109_ce67c4b8-6c95-4ab3-b170-c268c3b90d20 68462-109 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Glenmark Generics Inc., USA TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68462-110_ce67c4b8-6c95-4ab3-b170-c268c3b90d20 68462-110 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Glenmark Generics Inc., USA TOPIRAMATE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68462-113_a2e433a6-ad8c-48d9-b52a-398b1168a053 68462-113 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20090227 ANDA ANDA077654 Glenmark Generics Inc., USA CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68462-114_a2e433a6-ad8c-48d9-b52a-398b1168a053 68462-114 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20090227 ANDA ANDA077654 Glenmark Generics Inc., USA CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68462-115_a2e433a6-ad8c-48d9-b52a-398b1168a053 68462-115 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20090227 ANDA ANDA077654 Glenmark Generics Inc., USA CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68462-126_108f3609-672c-4ccd-aaca-557aa282619f 68462-126 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Glenmark Generics Inc., USA GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68462-127_108f3609-672c-4ccd-aaca-557aa282619f 68462-127 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Glenmark Generics Inc., USA GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68462-128_17fd3235-62a3-4e1d-9e83-7e345bd5983b 68462-128 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20060130 ANDA ANDA077651 Glenmark Generics Inc., USA ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68462-129_17fd3235-62a3-4e1d-9e83-7e345bd5983b 68462-129 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20060130 ANDA ANDA077651 Glenmark Generics Inc., USA ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68462-130_17fd3235-62a3-4e1d-9e83-7e345bd5983b 68462-130 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20060130 ANDA ANDA077651 Glenmark Generics Inc., USA ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68462-137_72edfb02-a5b2-42e3-93a8-75eed075e53b 68462-137 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077802 Glenmark Generics Inc., USA OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68462-138_72edfb02-a5b2-42e3-93a8-75eed075e53b 68462-138 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077802 Glenmark Generics Inc., USA OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68462-139_72edfb02-a5b2-42e3-93a8-75eed075e53b 68462-139 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077802 Glenmark Generics Inc., USA OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68462-140_d2dc9488-1f39-4f0c-9b8d-fe58073ca396 68462-140 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060719 ANDA ANDA077932 Glenmark Generics Inc., USA MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68462-141_d2dc9488-1f39-4f0c-9b8d-fe58073ca396 68462-141 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060719 ANDA ANDA077932 Glenmark Generics Inc., USA MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68462-153_ce67c4b8-6c95-4ab3-b170-c268c3b90d20 68462-153 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Glenmark Generics Inc., USA TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68462-157_f0f58f56-d258-4ddb-b402-a38dbfdfbf1c 68462-157 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Glenmark Generics Inc., USA ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68462-158_f0f58f56-d258-4ddb-b402-a38dbfdfbf1c 68462-158 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Glenmark Generics Inc., USA ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68462-159_b174882f-87f8-4e55-82c6-c8ab8fcc8462 68462-159 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20080523 ANDA ANDA078170 Glenmark Generics Inc., USA METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68462-160_b174882f-87f8-4e55-82c6-c8ab8fcc8462 68462-160 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20080523 ANDA ANDA078170 Glenmark Generics Inc., USA METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68462-161_b174882f-87f8-4e55-82c6-c8ab8fcc8462 68462-161 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20080523 ANDA ANDA078170 Glenmark Generics Inc., USA METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68462-162_2875b35b-0753-4d2a-8acf-73a4a12b21ea 68462-162 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Glenmark Generics Inc., USA CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68462-163_2875b35b-0753-4d2a-8acf-73a4a12b21ea 68462-163 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Glenmark Generics Inc., USA CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68462-164_2875b35b-0753-4d2a-8acf-73a4a12b21ea 68462-164 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Glenmark Generics Inc., USA CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68462-165_2875b35b-0753-4d2a-8acf-73a4a12b21ea 68462-165 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Glenmark Generics Inc., USA CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68462-178_1abc073c-87bb-47e8-a697-934b3a1c4c2b 68462-178 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070801 ANDA ANDA078314 Glenmark Generics Inc., USA NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68462-179_1abc073c-87bb-47e8-a697-934b3a1c4c2b 68462-179 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070801 ANDA ANDA078314 Glenmark Generics Inc., USA NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68462-180_fc7c2b93-5837-47ca-95eb-2a0f85be3873 68462-180 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20110608 ANDA ANDA090480 Glenmark Generics Inc.,USA MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 68462-181_72bfae43-534d-4b62-a407-a81bc9534d07 68462-181 HUMAN PRESCRIPTION DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20100804 ANDA ANDA090219 Glenmark Generics Inc., USA CLOTRIMAZOLE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 68462-188_1abc073c-87bb-47e8-a697-934b3a1c4c2b 68462-188 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Glenmark Generics Inc., USA NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68462-189_1abc073c-87bb-47e8-a697-934b3a1c4c2b 68462-189 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Glenmark Generics Inc., USA NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68462-190_1abc073c-87bb-47e8-a697-934b3a1c4c2b 68462-190 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Glenmark Generics Inc., USA NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68462-192_a4054a20-9abb-4477-a4ba-f31066848641 68462-192 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20080528 ANDA ANDA078541 Glenmark Generics Inc., USA MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 68462-195_8d4f0d79-aae2-4b31-b22c-270d4d234a68 68462-195 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 Glenmark Generics Inc., USA PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68462-196_8d4f0d79-aae2-4b31-b22c-270d4d234a68 68462-196 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 Glenmark Generics Inc., USA PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68462-197_8d4f0d79-aae2-4b31-b22c-270d4d234a68 68462-197 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 Glenmark Generics Inc., USA PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68462-198_8d4f0d79-aae2-4b31-b22c-270d4d234a68 68462-198 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20071228 ANDA ANDA077987 Glenmark Generics Inc., USA PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68462-199_c6eb489d-2946-4c14-839f-d4af761ead31 68462-199 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20140707 ANDA ANDA090032 Glenmark Generics Inc., USA TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68462-200_c6eb489d-2946-4c14-839f-d4af761ead31 68462-200 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20140707 ANDA ANDA090032 Glenmark Generics Inc., USA TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68462-201_c6eb489d-2946-4c14-839f-d4af761ead31 68462-201 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20140707 ANDA ANDA090032 Glenmark Generics Inc., USA TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68462-204_8a833cc0-9bfb-4538-813b-b4d06f31ec6a 68462-204 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE ORAL 20101215 NDA AUTHORIZED GENERIC NDA200534 Glenmark Generics, Inc OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68462-205_30b478aa-eb7f-4a97-9cd0-edfc0f368e7a 68462-205 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100318 ANDA ANDA090718 Glenmark Generics Inc., USA HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 25; 15 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68462-206_30b478aa-eb7f-4a97-9cd0-edfc0f368e7a 68462-206 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100318 ANDA ANDA090718 Glenmark Generics Inc., USA HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5; 15 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68462-207_30b478aa-eb7f-4a97-9cd0-edfc0f368e7a 68462-207 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100318 ANDA ANDA090718 Glenmark Generics Inc., USA HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE 12.5; 7.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68462-208_242d7eaf-0fab-424f-8e54-a753efef830a 68462-208 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET, FILM COATED ORAL 20101231 ANDA ANDA090416 Glenmark Generics Inc., USA MOEXIPRIL HYDROCHLORIDE 15 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68462-209_242d7eaf-0fab-424f-8e54-a753efef830a 68462-209 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET, FILM COATED ORAL 20101231 ANDA ANDA090416 Glenmark Generics Inc., USA MOEXIPRIL HYDROCHLORIDE 7.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68462-220_36ac5e3c-5dc1-493b-94ea-3c2fcfa44d9c 68462-220 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20090203 ANDA ANDA079139 Glenmark Generics Inc., USA LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] 68462-221_36ac5e3c-5dc1-493b-94ea-3c2fcfa44d9c 68462-221 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20090203 ANDA ANDA079139 Glenmark Generics Inc., USA LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 68462-222_36ac5e3c-5dc1-493b-94ea-3c2fcfa44d9c 68462-222 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20090203 ANDA ANDA079139 Glenmark Generics Inc., USA LITHIUM CARBONATE 600 mg/1 Mood Stabilizer [EPC] 68462-223_e12f08ab-3d13-4d3c-a8a0-342b03c128b4 68462-223 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101227 ANDA ANDA091544 Glenmark Generics Inc., USA LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 68462-224_c7864a5b-c6ad-498d-b609-691877b089e8 68462-224 HUMAN PRESCRIPTION DRUG Lithium Carbonate ER Lithium Carbonate TABLET ORAL 20110214 ANDA ANDA091616 Glenmark Generics Inc., USA LITHIUM CARBONATE 450 mg/1 68462-225_b5c899d6-70fa-4609-84ca-0ec2b604aef5 68462-225 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone furoate OINTMENT TOPICAL 20080528 ANDA ANDA078571 Glenmark Generics Inc., USA MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 68462-226_ac539a72-77e4-419c-b1d9-42002e9cecf7 68462-226 HUMAN PRESCRIPTION DRUG Ezetimibe Ezetimibe TABLET ORAL 20111231 ANDA ANDA078560 Glenmark Generics Inc., USA EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] 68462-228_dd0daddf-8732-4527-a46a-5eb66a834fb6 68462-228 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090219 ANDA ANDA079099 Glenmark Generics Inc., USA LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68462-229_dd0daddf-8732-4527-a46a-5eb66a834fb6 68462-229 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090219 ANDA ANDA079099 Glenmark Generics Inc., USA LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68462-230_ba1b1d02-21f8-40b0-a6ef-0c0e0cb89ff0 68462-230 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Glenmark Generics Inc., USA OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68462-231_ba1b1d02-21f8-40b0-a6ef-0c0e0cb89ff0 68462-231 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Glenmark Generics Inc., USA OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68462-232_ba1b1d02-21f8-40b0-a6ef-0c0e0cb89ff0 68462-232 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Glenmark Generics Inc., USA OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68462-233_7d7e7667-76be-4c07-b270-dbd4cf18fe4b 68462-233 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA090365 Glenmark Generics, Inc. USA FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68462-234_7d7e7667-76be-4c07-b270-dbd4cf18fe4b 68462-234 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA090365 Glenmark Generics, Inc. USA FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68462-235_7d7e7667-76be-4c07-b270-dbd4cf18fe4b 68462-235 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA090365 Glenmark Generics, Inc. USA FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68462-243_c8edc9b4-0036-404f-95ae-586315fdc380 68462-243 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20120504 ANDA ANDA090169 Glenmark Generics Inc., USA LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68462-244_c8edc9b4-0036-404f-95ae-586315fdc380 68462-244 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20120504 ANDA ANDA090169 Glenmark Generics Inc., USA LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68462-245_c8edc9b4-0036-404f-95ae-586315fdc380 68462-245 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20120504 ANDA ANDA090169 Glenmark Generics Inc., USA LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68462-246_c8edc9b4-0036-404f-95ae-586315fdc380 68462-246 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20120504 ANDA ANDA090169 Glenmark Generics Inc., USA LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68462-248_342c8499-74fe-4f3b-97c0-f144244b2f8e 68462-248 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Glenmark Generics Inc., USA RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68462-249_342c8499-74fe-4f3b-97c0-f144244b2f8e 68462-249 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Glenmark Generics Inc., USA RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68462-253_68585b72-49f7-4b89-8fde-eb706febf38b 68462-253 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Glenmark Generics Inc., USA ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68462-254_68585b72-49f7-4b89-8fde-eb706febf38b 68462-254 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Glenmark Generics Inc., USA ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68462-255_68585b72-49f7-4b89-8fde-eb706febf38b 68462-255 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Glenmark Generics Inc., USA ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68462-256_68585b72-49f7-4b89-8fde-eb706febf38b 68462-256 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Glenmark Generics Inc., USA ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68462-257_68585b72-49f7-4b89-8fde-eb706febf38b 68462-257 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Glenmark Generics Inc., USA ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68462-258_68585b72-49f7-4b89-8fde-eb706febf38b 68462-258 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Glenmark Generics Inc., USA ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68462-259_68585b72-49f7-4b89-8fde-eb706febf38b 68462-259 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Glenmark Generics Inc., USA ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68462-260_f861e8ad-a3cb-4e11-bba6-205091e450f5 68462-260 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090917 ANDA ANDA078906 Glenmark Generics Inc.,USA VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68462-290_d12e2203-43c6-497d-852d-e4b1f6a644d2 68462-290 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20080923 ANDA ANDA078930 Glenmark Generics Inc., USA BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68462-291_4f70fb45-84d5-46ec-af54-871064650ab4 68462-291 HUMAN PRESCRIPTION DRUG Linezolid Linezolid TABLET ORAL 20111231 ANDA ANDA078987 Glenmark Generics Inc., USA LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] 68462-292_f861e8ad-a3cb-4e11-bba6-205091e450f5 68462-292 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA090700 Glenmark Generics Inc.,USA VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68462-293_f861e8ad-a3cb-4e11-bba6-205091e450f5 68462-293 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA090700 Glenmark Generics Inc.,USA VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68462-294_ab4db523-c971-4d92-80f8-b7ddddfd712f 68462-294 HUMAN PRESCRIPTION DRUG Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100830 ANDA ANDA079135 Glenmark Generics Inc., USA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 1; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68462-295_ab4db523-c971-4d92-80f8-b7ddddfd712f 68462-295 HUMAN PRESCRIPTION DRUG Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100526 ANDA ANDA079135 Glenmark Generics Inc., USA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2; 180 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68462-296_ab4db523-c971-4d92-80f8-b7ddddfd712f 68462-296 HUMAN PRESCRIPTION DRUG Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100526 ANDA ANDA079135 Glenmark Generics Inc., USA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68462-297_33c30504-24b6-470a-8077-59926fe61132 68462-297 HUMAN PRESCRIPTION DRUG Ciclopirox Olamine Ciclopirox Olamine CREAM TOPICAL 20091113 ANDA ANDA090273 Glenmark Generics Inc., USA CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 68462-299_2969e37b-c7f1-4b23-b151-d2c96610a8b8 68462-299 HUMAN PRESCRIPTION DRUG Alclometasone Dipropionate Alclometasone Dipropionate OINTMENT TOPICAL 20090730 ANDA ANDA079227 Glenmark Generics Inc., USA ALCLOMETASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68462-300_2969e37b-c7f1-4b23-b151-d2c96610a8b8 68462-300 HUMAN PRESCRIPTION DRUG Alclometasone Dipropionate Alclometasone Dipropionate CREAM TOPICAL 20090623 ANDA ANDA079061 Glenmark Generics Inc., USA ALCLOMETASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68462-302_e704c26d-f5c4-4b38-b24a-5dcb4e7c8d48 68462-302 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 Glenmark Generics Inc., USA INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68462-303_bac27291-bf77-4545-ad48-772eb780aa66 68462-303 HUMAN PRESCRIPTION DRUG HEATHER Norethindrone TABLET ORAL 20100423 ANDA ANDA090454 Glenmark Generics Inc NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 68462-304_80a6bc90-96e5-4572-98ea-5c01183f4bbe 68462-304 HUMAN PRESCRIPTION DRUG Norethindrone Acetate Norethindrone Acetate TABLET ORAL 20100721 ANDA ANDA091090 Glenmark Generics Inc., USA NORETHINDRONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 68462-305_b521a5f0-83f8-4037-a2e4-eb64bc57830c 68462-305 HUMAN PRESCRIPTION DRUG Norethindrone Norethindrone TABLET ORAL 20101103 ANDA ANDA091209 Glenmark Generics Inc.,USA NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 68462-309_b2881eb1-5660-4b62-b0d6-e8c8792d231b 68462-309 HUMAN PRESCRIPTION DRUG Norgestimate and Ethinyl Estradiol Norgestimate and Ethinyl Estradiol KIT 20120406 ANDA ANDA200538 Glenmark Generics Inc., USA 68462-310_b0ac6afd-4888-4bf0-9178-553e53819708 68462-310 HUMAN PRESCRIPTION DRUG Calcipotriene Calcipotriene OINTMENT TOPICAL 20100324 ANDA ANDA090633 Glenmark Generics Inc., USA CALCIPOTRIENE 50 ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] 68462-316_00d127e2-3ee8-4dc9-b210-7aa3a380b92a 68462-316 HUMAN PRESCRIPTION DRUG BRIELLYN Norethindrone and Ethinyl Estradiol KIT 20110323 ANDA ANDA090538 Glenmark Generics Inc., USA 68462-318_644dec7a-1c0d-4161-a454-e280023f5735 68462-318 HUMAN PRESCRIPTION DRUG VIORELE Desogestrel and Ethinyl Estradiol and Ethinyl Estradiol KIT 20120404 ANDA ANDA091346 Glenmark Generics Inc., USA 68462-329_ab4db523-c971-4d92-80f8-b7ddddfd712f 68462-329 HUMAN PRESCRIPTION DRUG Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100505 ANDA ANDA079135 Glenmark Generics Inc., USA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 4; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68462-330_f5c8c8b1-aac3-4de5-999b-9087c3102913 68462-330 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20101008 ANDA ANDA090781 Glenmark Generics Inc., USA PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68462-331_f5c8c8b1-aac3-4de5-999b-9087c3102913 68462-331 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20101008 ANDA ANDA090781 Glenmark Generics Inc., USA PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68462-332_f5c8c8b1-aac3-4de5-999b-9087c3102913 68462-332 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20101008 ANDA ANDA090781 Glenmark Generics Inc., USA PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68462-333_f5c8c8b1-aac3-4de5-999b-9087c3102913 68462-333 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20101008 ANDA ANDA090781 Glenmark Generics Inc., USA PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68462-334_f5c8c8b1-aac3-4de5-999b-9087c3102913 68462-334 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20101008 ANDA ANDA090781 Glenmark Generics Inc., USA PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] 68462-339_e45624a4-58bf-47c2-9a22-de072ae7c662 68462-339 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20110114 ANDA ANDA090828 Glenmark Generics Inc. USA SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 68462-340_e45624a4-58bf-47c2-9a22-de072ae7c662 68462-340 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20110114 ANDA ANDA090828 Glenmark Generics Inc. USA SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 68462-341_92acaa5e-4231-4391-90aa-81ed4cf1c21c 68462-341 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Glenmark Generics Inc., USA HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 68462-342_92acaa5e-4231-4391-90aa-81ed4cf1c21c 68462-342 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Glenmark Generics Inc., USA HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 68462-343_92acaa5e-4231-4391-90aa-81ed4cf1c21c 68462-343 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Glenmark Generics Inc., USA HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 68462-344_92acaa5e-4231-4391-90aa-81ed4cf1c21c 68462-344 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Glenmark Generics Inc., USA HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 68462-346_b1e205dc-66aa-40bd-b892-9ba669540ac2 68462-346 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET ORAL 20110225 ANDA ANDA090385 Glenmark Generics Inc.,USA LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 68462-347_af29571c-f584-4a5b-aca1-eb2e4e6fa09d 68462-347 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20101220 NDA AUTHORIZED GENERIC NDA200535 Glenmark Generics, Inc OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 68462-356_b66a2af9-ac24-436e-94ed-5137f204152a 68462-356 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20100713 ANDA ANDA090355 Glenmark Generics Inc., USA THEOPHYLLINE ANHYDROUS 600 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 68462-358_5276f530-14bc-492d-974b-913fd06bf52e 68462-358 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Glenmark Generics Inc., USA NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68462-359_5276f530-14bc-492d-974b-913fd06bf52e 68462-359 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Glenmark Generics Inc., USA NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68462-360_a2d99900-2c52-47f9-b155-4cda6711b6e7 68462-360 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080301 ANDA ANDA040812 Glenmark Generics Inc., USA HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 68462-361_a2d99900-2c52-47f9-b155-4cda6711b6e7 68462-361 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080301 ANDA ANDA040812 Glenmark Generics Inc., USA HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 68462-362_a2d99900-2c52-47f9-b155-4cda6711b6e7 68462-362 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080301 ANDA ANDA040812 Glenmark Generics Inc., USA HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 68462-380_b66a2af9-ac24-436e-94ed-5137f204152a 68462-380 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20100713 ANDA ANDA090355 Glenmark Generics Inc., USA THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 68462-381_f1ce57e8-d3fe-422c-8724-3101c258898a 68462-381 HUMAN PRESCRIPTION DRUG Riluzole Riluzole TABLET, FILM COATED ORAL 20130618 ANDA ANDA091394 Glenmark Generics Inc.,USA RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] 68462-382_28bbc85a-b315-4a78-b606-c40ceb7a0554 68462-382 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091166 Glenmark Generics Inc. USA ESZOPICLONE 1 mg/1 CIV 68462-383_28bbc85a-b315-4a78-b606-c40ceb7a0554 68462-383 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091166 Glenmark Generics Inc. USA ESZOPICLONE 2 mg/1 CIV 68462-384_28bbc85a-b315-4a78-b606-c40ceb7a0554 68462-384 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091166 Glenmark Generics Inc. USA ESZOPICLONE 3 mg/1 CIV 68462-385_f9d37016-5714-4e6d-a834-8e932b486427 68462-385 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate LOTION TOPICAL 20100809 ANDA ANDA078541 Glenmark Generics Inc., USA MOMETASONE FUROATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] 68462-388_00dc82a1-2d44-499b-9f88-d693fdb0dd50 68462-388 HUMAN PRESCRIPTION DRUG MARLISSA Levonorgestrel and Ethinyl Estradiol KIT 20120229 ANDA ANDA091452 Glenmark Generics Inc.,USA 68462-392_adc73278-2cfd-44b0-a80d-3f58fb6690bc 68462-392 HUMAN PRESCRIPTION DRUG montelukast sodium montelukast sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA090926 Glenmark Generics Inc., USA MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 68462-394_07ffded5-bd9a-4ca7-b722-bc8afb3cde8b 68462-394 HUMAN PRESCRIPTION DRUG ALYACEN 1/35 norethindrone and ethinyl estradiol KIT 20120119 ANDA ANDA091634 Glenmark Generics Inc., USA 68462-403_2ce5d9d8-6010-405c-a293-0be8a8f998a9 68462-403 HUMAN PRESCRIPTION DRUG Adapalene Adapalene GEL TOPICAL 20100701 ANDA ANDA091314 Glenmark Generics Inc., USA ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 68462-404_f663c018-c985-4292-9d52-886af43f1842 68462-404 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20110818 ANDA ANDA091211 Glenmark Generics Inc., USA ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 68462-406_e704c26d-f5c4-4b38-b24a-5dcb4e7c8d48 68462-406 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 Glenmark Generics Inc., USA INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68462-425_471123bb-f0b6-486b-b5f8-b0d3e06fe56c 68462-425 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20110715 ANDA ANDA090618 Glenmark Generics Inc.,USA NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68462-426_471123bb-f0b6-486b-b5f8-b0d3e06fe56c 68462-426 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20110715 ANDA ANDA090618 Glenmark Generics Inc.,USA NIZATIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68462-427_98b6ba2d-a485-47f2-b320-783f959fedd2 68462-427 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate LOTION TOPICAL 20111013 ANDA ANDA090759 Glenmark Generics Inc., USA FLUTICASONE PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68462-435_43e9ef60-2d85-4394-906b-93042fea099a 68462-435 HUMAN PRESCRIPTION DRUG Acamprosate Calcium Acamprosate Calcium TABLET, DELAYED RELEASE ORAL 20130716 ANDA ANDA202229 Glenmark Generics Inc.,USA ACAMPROSATE CALCIUM 333 mg/1 68462-455_4aef3b99-7e37-4f37-84f2-2488b8ff5fd1 68462-455 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox GEL TOPICAL 20120229 ANDA ANDA091595 Glenmark Generics CICLOPIROX 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 68462-461_519e72cb-3c08-49dc-aa51-d098dc152937 68462-461 HUMAN PRESCRIPTION DRUG Trospium Chloride Trospium Chloride TABLET, FILM COATED ORAL 20100813 ANDA ANDA091575 Glenmark Generics Inc., USA TROSPIUM CHLORIDE 20 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 68462-464_8a58561e-790c-4115-824b-dedfaa10eec5 68462-464 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate Hydrocortisone Butyrate CREAM TOPICAL 20131205 ANDA ANDA202145 Glenmark Generics Inc.,USA HYDROCORTISONE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68462-465_99c66300-bd75-4b31-9fab-88c6e4b12688 68462-465 HUMAN PRESCRIPTION DRUG rizatriptan benzoate rizatriptan benzoate TABLET ORAL 20121231 ANDA ANDA201967 Glenmark Generics Inc., USA RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68462-466_99c66300-bd75-4b31-9fab-88c6e4b12688 68462-466 HUMAN PRESCRIPTION DRUG rizatriptan benzoate rizatriptan benzoate TABLET ORAL 20121231 ANDA ANDA201967 Glenmark Generics Inc., USA RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68462-467_4de33a24-db69-444a-b04d-c69ccba57ab2 68462-467 HUMAN PRESCRIPTION DRUG rizatriptan benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA201914 Glenmark Generics Inc., USA RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68462-468_4de33a24-db69-444a-b04d-c69ccba57ab2 68462-468 HUMAN PRESCRIPTION DRUG rizatriptan benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA201914 Glenmark Generics Inc., USA RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68462-473_eed3b473-17ae-4e51-8442-63d2173a8e2a 68462-473 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET ORAL 20110712 ANDA ANDA090801 Glenmark Generics Inc.,USA URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 68462-474_eed3b473-17ae-4e51-8442-63d2173a8e2a 68462-474 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET ORAL 20110712 ANDA ANDA090801 Glenmark Generics Inc.,USA URSODIOL 500 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] 68462-497_333caafc-2e63-49f8-a0c6-534e528d228d 68462-497 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20130514 ANDA ANDA201779 Glenmark Generics Inc.,USA ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68462-498_333caafc-2e63-49f8-a0c6-534e528d228d 68462-498 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20130514 ANDA ANDA201779 Glenmark Generics Inc.,USA ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68462-499_a734b368-6008-441c-ab44-5634e46be9a4 68462-499 HUMAN PRESCRIPTION DRUG zolmiptriptan zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130514 ANDA ANDA202560 Glenmark Generics Inc.,USA ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68462-500_a734b368-6008-441c-ab44-5634e46be9a4 68462-500 HUMAN PRESCRIPTION DRUG zolmiptriptan zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130514 ANDA ANDA202560 Glenmark Generics Inc.,USA ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68462-505_50f1c216-78c6-4b93-b732-b3beeb78bd62 68462-505 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20140714 ANDA ANDA091282 Glenmark Generics Inc., USA FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68462-531_ea742af6-9359-46c3-9164-ab53e8c1461e 68462-531 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 20130920 ANDA ANDA202838 Glenmark Generics Inc.,USA DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68462-536_663e39a9-a29e-473f-89ec-4c7c6bc27b8a 68462-536 HUMAN PRESCRIPTION DRUG Imiquimod Imiquimod CREAM TOPICAL 20120306 ANDA ANDA201994 Glenmark Generics Inc.,USA IMIQUIMOD 50 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 68462-554_f87ddb8c-2601-4a75-9241-63cb11b49b1f 68462-554 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20090709 ANDA ANDA090228 Glenmark Generics Inc., USA FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68462-555_f87ddb8c-2601-4a75-9241-63cb11b49b1f 68462-555 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20090709 ANDA ANDA090228 Glenmark Generics Inc., USA FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68462-556_07ffded5-bd9a-4ca7-b722-bc8afb3cde8b 68462-556 HUMAN PRESCRIPTION DRUG ALYACEN 7/7/7 norethindrone and ethinyl estradiol KIT 20120119 ANDA ANDA091636 Glenmark Generics Inc., USA 68462-563_054a0948-4520-4df2-8780-59efb95e9827 68462-563 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Pediatric atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20110915 NDA AUTHORIZED GENERIC NDA021078 Glenmark Generics Inc ATOVAQUONE; PROGUANIL HYDROCHLORIDE 62.5; 25 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] 68462-564_e21e4a5b-d32e-452f-aed3-ad4f6f49a35a 68462-564 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin CREAM TOPICAL 20130124 ANDA ANDA201587 Glenmark Generics Inc., USA MUPIROCIN CALCIUM 2 g/100g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 68462-565_4d4d99b8-929c-419a-a760-8f07d7d0179d 68462-565 HUMAN PRESCRIPTION DRUG Norgestimate and Ethinyl Estradiol Norgestimate and Ethinyl Estradiol KIT 20110617 ANDA ANDA200494 Glenmark Generics Inc., USA 68470-1001_41f362a0-4996-42fb-8ca2-3b4f1ca7cbcd 68470-1001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20051111 UNAPPROVED MEDICAL GAS Super Care Inc OXYGEN 99 L/100L 68472-028_b84ce3ef-a468-413c-ad33-3a4e67ad5c09 68472-028 HUMAN OTC DRUG Botanics Complexion Refining Day Moisture Lotion Sunscreen SPF 12 Octinoxate and Avobenzone LOTION TOPICAL 20100127 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE 2.25; 3.75 mL/75mL; mL/75mL 68472-049_3e1b23c3-3ef8-4876-ab8b-843f4cfe03cb 68472-049 HUMAN OTC DRUG Botanics Daily Hand Therapy Sunscreen SPF 10 Octinoxate and Avobenzone CREAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE 1.5; 3 mL/75mL; mL/75mL 68472-050_ddc7e748-7ac2-4b0f-bd0f-0ad02d680f3a 68472-050 HUMAN OTC DRUG No7 Stay Perfect Foundation Compact Sunscreen SPF 15 New Ivory Octinoxate and Titanium Dioxide POWDER TOPICAL 20100303 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE .6; .144 g/12g; g/12g 68472-052_eead2ef6-ed55-43f3-825f-17606f05fce8 68472-052 HUMAN OTC DRUG No7 Stay Perfect Foundation Compact Sunscreen SPF 15 Blonde Octinoxate and Titanium Dioxide POWDER TOPICAL 20100303 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE .6; .144 g/12g; g/12g 68472-054_cdbc22f2-9711-4227-a125-f624a20ce1ac 68472-054 HUMAN OTC DRUG No7 Stay Perfect Foundation Compact Sunscreen SPF 15 Almond Octinoxate and Titanium Dioxide POWDER TOPICAL 20100303 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE .6; .144 g/12g; g/12g 68472-056_baf9148b-fb54-48ef-a82f-f0a3d66b4822 68472-056 HUMAN OTC DRUG BOTANICS FACE RENEWAL CREAM SUNSCREEN SPF 15 OCTINOXATE AND AVOBENZONE CREAM TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE 1.5; 3 mL/50mL; mL/50mL 68472-057_e943640c-90ec-4636-afe6-356b4dd33945 68472-057 HUMAN OTC DRUG BOTANICS FACE LIFT FIRMING CREAM SUNSCREEN SPF 10 OCTINOXATE, AVOBENZONE AND OCTISALATE CREAM TOPICAL 20100222 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3.75; 1.25 mL/50mL; mL/50mL; mL/50mL 68472-060_56965549-2268-4282-9a18-4fe4d32b9296 68472-060 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 New Ivory 10 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-062_069b2791-f716-4e6e-99b3-efdc26b038e7 68472-062 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Blonde 20 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-063_6cdf56cd-53a4-4258-8164-406ed224f568 68472-063 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Almond 30 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-066_fc0d5d03-c54e-4bdd-96f2-bc03cfbb947c 68472-066 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Vanilla 25 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-067_964b87c9-42d7-46c8-93f4-28b39e087b79 68472-067 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Truffle 50 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-069_48b4dcec-cfe1-484d-bfcf-4a7e2a415f51 68472-069 HUMAN OTC DRUG No7 Soft and Sheer Tinted Moisturiser Fair Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100305 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; .95 mL/50mL; mL/50mL 68472-070_208ae123-310c-40eb-96aa-d169115cf0d0 68472-070 HUMAN OTC DRUG No7 Soft and Sheer Tinted Moisturiser Medium Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100305 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; .95 mL/50mL; mL/50mL 68472-071_0108adde-d97f-4904-bce7-83605ad03ea9 68472-071 HUMAN OTC DRUG No7 Soft and Sheer Tinted Moisturiser Dark Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100305 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; .95 mL/50mL; mL/50mL 68472-072_b5c376ef-e8a3-4f6a-b513-2bf5624595a3 68472-072 HUMAN OTC DRUG No7 Advanced Hydration Day Cream Sunscreen SPF 12 Octinoxate and Avobenzone CREAM TOPICAL 20091203 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE 1.5; 2.5 mL/50mL; mL/50mL 68472-073_b4c0b7db-4845-4504-b965-271b3d9a94f9 68472-073 HUMAN OTC DRUG No7 Time Resisting Day Cream Sunscreen SPF 12 Octinoxate and Avobenzone CREAM TOPICAL 20091208 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE 1.25; 2.5 mL/50mL; mL/50mL 68472-074_fe204e2f-8eb3-4a47-a5a6-508bc3eb99fd 68472-074 HUMAN OTC DRUG Botanics Day Moisture Sunscreen SPF 12 Octinoxate, Avobenzone and Octisalate CREAM TOPICAL 20100225 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3.75; 1.25 mL/50mL; mL/50mL; mL/50mL 68472-075_8ff99d51-0e1f-4854-813d-31a4d3eed7b3 68472-075 HUMAN OTC DRUG No7 Lifting and Firming Day Sunscreen SPF 8 Octinoxate, Avobenzone and Octisalate EMULSION TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3.75; 1 mL/50mL; mL/50mL; mL/50mL 68472-077_2b0c3b4e-34ef-4d95-be8b-e68f3508ad2b 68472-077 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Porcelain 05 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-078_c56c486d-9d17-4f54-bb67-b3969f856fd3 68472-078 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 New Ivory 10 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-079_ddb6adde-e0bf-485d-8361-8f389e75c8ea 68472-079 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Nude 15 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-080_2e2e580d-79d3-44d1-a53a-7dfa9fdea2b1 68472-080 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Blonde 20 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100111 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-081_689ceca5-95fb-4134-90ca-a77337121bdb 68472-081 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Vanilla 25 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-082_93323e81-3ad1-4b49-9d2c-6c43ac357a54 68472-082 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Almond 35 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100111 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-083_f18b20b5-5fc9-49cb-aadb-f767799669fa 68472-083 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Walnut 45 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-084_5780f42e-69f8-4742-a934-fed281b6ad03 68472-084 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Truffle 50 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-087_195fe603-04b5-42cc-8fbc-8af1302d6bae 68472-087 HUMAN OTC DRUG No7 Stay Perfect Foundation Compact Sunscreen SPF 15 Buff Octinoxate and Titanium Dioxide POWDER TOPICAL 20100303 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE .6; .144 g/12g; g/12g 68472-088_581733b5-767d-4adf-9baf-e4e3b2a58d68 68472-088 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 05 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-089_d9f074c3-f0c7-44a2-8222-e88b770c9352 68472-089 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Buff 15 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-090_02a34595-7f97-4c08-9965-2b1ca0c2d0b4 68472-090 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Suede 40 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-091_8c5f665d-4b60-40c8-8635-fe9861f109ca 68472-091 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Espresso 45 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-092_c0afb538-57bb-4ea6-9ab2-4b0888760583 68472-092 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Tan 35 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-093_a9ede626-6d99-496c-9cce-47eedfa547b1 68472-093 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Cocoa 55 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-094_b14b538b-ba15-4180-a1d5-d990fedc19e9 68472-094 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Mocha 60 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-095_4d7e37f1-cc33-4ab2-8ff0-e9641d00d362 68472-095 HUMAN OTC DRUG No7 Radiant Glow Foundation Sunscreen SPF 15 Cream 05 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100324 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-096_e6a5a4ea-c0dd-4295-9f13-c086ed1b805f 68472-096 HUMAN OTC DRUG No7 Radiant Glow Foundation Sunscreen SPF 15 Buff 15 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100324 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-097_8cf10399-edd8-4d8b-89d5-6a10ae1debc8 68472-097 HUMAN OTC DRUG No7 Radiant Glow Foundation Sunscreen SPF 15 Suede 40 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100324 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-098_cd9ae219-8d48-4cf2-b0a7-04bf1ac39ddb 68472-098 HUMAN OTC DRUG No7 Radiant Glow Foundation Sunscreen SPF 15 Cocoa 55 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100324 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL 68472-099_bd355393-0a28-4ce0-ba32-fb588a9c2982 68472-099 HUMAN OTC DRUG BOTANICS TRIPLE ACTION DAY MOISTURE CREAM SUNSCREEN SPF 15 OCTINOXATE AND AVOBENZONE CREAM TOPICAL 20100120 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE 1.5; 2.25 mL/50mL; mL/50mL 68472-100_c20ef608-54c8-4cf1-94d4-9a6eb42b5298 68472-100 HUMAN OTC DRUG No7 Protect and Perfect Day Cream Sunscreen SPF 15 Avobenzone , Octinoxate and Octisalate EMULSION TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3; 1.25 mL/50mL; mL/50mL; mL/50mL 68472-101_bc37ce36-982d-4726-ad5b-aa0aa9c68355 68472-101 HUMAN OTC DRUG No7 Protect and Perfect Hand Cream Sunscreen SPF 15 Octinoxate, Avobenzone and Octisalate CREAM TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE; OCTISALATE 2.25; 5.625; 1.5 mL/75mL; mL/75mL; mL/75mL 68472-102_2a56fde5-475d-4449-8c84-9ac076774c9b 68472-102 HUMAN OTC DRUG No7 Rebalancing Day Fluid Sunscreen SPF 15 Octinoxate and Avobenzone and Ensulizole LOTION TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; ENSULIZOLE; OCTINOXATE 2; 2; 6 mL/100mL; mL/100mL; mL/100mL 68472-103_088d00b8-1da6-4637-abd1-e416399b5e3d 68472-103 HUMAN OTC DRUG No7 Protect and Perfect Skincare System Day Sunscreen SPF 15 Octinoxate, Avobenzone and Octisalate EMULSION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3; 1.25 mL/50mL; mL/50mL; mL/50mL 68472-104_072059a5-0135-4222-9968-a20f24bcad2d 68472-104 HUMAN OTC DRUG No7 Lifting and Firming Skincare System Day Sunscreen SPF 8 Avobenzone, Octinoxate and Octisalate EMULSION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3.75; 1 mL/50mL; mL/50mL; mL/50mL 68472-105_15eb367a-9154-44dd-99f1-a2a995057523 68472-105 HUMAN OTC DRUG No7 Beautiful Skin Day Normal Oily Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 mL/50mL; mL/50mL; mL/50mL 68472-106_2fcc888b-ba01-4e62-9710-481764748332 68472-106 HUMAN OTC DRUG No7 Beautiful Skin day Normal Dry Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 mL/50mL; mL/50mL; mL/50mL 68472-107_8d304fbb-7082-4912-bf04-196d3bae803c 68472-107 HUMAN OTC DRUG No7 Beautiful Skin Day Dry Very Dry Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 mL/50mL; mL/50mL; mL/50mL 68472-108_6c38b673-07f7-43a7-974e-ec172a0c7e85 68472-108 HUMAN OTC DRUG No7 Beautiful Skin Oil Free Skin Protector All Skin Types SPF 25 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.75; 3.25 mL/50mL; mL/50mL; mL/50mL 68472-109_55d85b4c-bc8f-4dab-9f92-0670e18ae36f 68472-109 HUMAN OTC DRUG No7 Protect and Perfect Day Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3; 1.25 mL/50mL; mL/50mL; mL/50mL 68472-110_4791f277-99bc-4ba4-a238-54b8e0d9e4cb 68472-110 HUMAN OTC DRUG No7 Lift and Luminate Day Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octocrylene CREAM TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.5; 2.5; .5 mL/50mL; mL/50mL; mL/50mL 68472-111_25eb489f-ac73-4e84-9397-88fb9effcfc8 68472-111 HUMAN OTC DRUG No7 Protect and Perfect Hand Cream Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE; OCTISALATE 2.25; 5.625; 1.5 mL/75mL; mL/75mL; mL/75mL 68472-114_a315a37b-81c7-45dc-bd58-fd51d54f92fd 68472-114 HUMAN OTC DRUG No7 Lift and Luminate Day Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octocrylene EMULSION TOPICAL 20120530 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.5; 2.5; .5 mL/50mL; mL/50mL; mL/50mL 68472-117_bcfa06d4-6751-4990-9c09-7bc38489a4d2 68472-117 HUMAN PRESCRIPTION DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Calico OCTINOXATE EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g 68472-118_1fd70fad-163f-4f1e-9194-5452e451e0fb 68472-118 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g 68472-119_9cda6ede-594b-4caf-bbf2-b1aaf2de333b 68472-119 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g 68472-120_0e00ba2f-71f5-473a-b930-4dd5a256800a 68472-120 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Cool Beige OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g 68472-121_2884016a-e302-4364-8d71-3f3e50c40e9a 68472-121 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g 68472-122_01bf7485-87ad-40b0-99c3-d2fe7ab6f27d 68472-122 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Wheat OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g 68472-123_e0f06191-8954-4d5f-a6d9-b8c677d2d739 68472-123 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Honey OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g 68472-124_79d6ee52-b386-4732-bbcc-217545c33311 68472-124 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Mocha OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g 68472-125_002162bf-1086-4491-94c4-4f67bb81e736 68472-125 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Ebony OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g 68472-126_90a573b2-aac5-433b-8be9-3283d919d2df 68472-126 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Calico Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 2.25 g/30g 68472-127_c94cbbf3-4f0d-4aa5-a19b-373dc34a1abd 68472-127 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 2.25 g/30g 68472-128_b06de144-d8ff-4116-8099-ae8f83e210ff 68472-128 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 2.25 g/30g 68472-129_406f8f5a-75a7-4eac-a53f-05ad332b0dab 68472-129 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Cool Beige Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 2.25 g/30g 68472-130_ed2a2cb7-17ae-4127-ad9a-568aec5153b2 68472-130 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 2.25 g/30g 68472-131_f356851f-0259-46f4-b5dd-fe7aadb356a3 68472-131 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Wheat Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 2.25 g/30g 68472-132_43dc78ed-5236-4fa8-a6d0-ee0844f0f730 68472-132 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Mocha Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 2.25 g/30g 68472-133_7354c9b3-8b3b-4678-8bba-0b996b43b893 68472-133 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Ebony Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 2.25 g/30g 68472-134_c72b87cb-710b-4e79-b0fb-cb5202af3fad 68472-134 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g 68472-135_8bd3e2f3-a821-4017-9318-a80dd1d3b752 68472-135 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g 68472-136_23c52464-241a-454d-b22a-5f4499d4d246 68472-136 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Beige Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g 68472-137_1dbf699e-be1f-4bf3-b2fa-d96a8f671f9d 68472-137 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g 68472-138_4e5baf67-7194-46f9-bf8f-c76b86e2f3d0 68472-138 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Wheat Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g 68472-139_87b2faa3-3ae1-4123-8477-cade940866f9 68472-139 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Mocha Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g 68472-140_6706ceca-3443-47c1-859c-f38f4dc2c1ca 68472-140 HUMAN OTC DRUG No7 Dual Action Tinted Moisturiser Fair Avobenzone, Octisalate and Octocrylene EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g 68472-141_aee6a64c-183b-4dc4-b9b6-de9e98fbdc59 68472-141 HUMAN OTC DRUG No7 Dual Action Tinted Moisturiser Medium Avobenzone, Octisalate and Octocrylene EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g 68472-159_1f793a15-0adf-4d94-b53b-9dcedf799621 68472-159 HUMAN OTC DRUG No7 CC Cream Light Octinoxate, Octocrylene EMULSION TOPICAL 20140430 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; OCTOCRYLENE 3; 3.2 g/40g; g/40g 68472-160_689749bd-595c-4302-a4e5-e6814e3379a0 68472-160 HUMAN OTC DRUG No7 CC Cream Medium Octinoxate, Octocrylene EMULSION TOPICAL 20140430 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; OCTOCRYLENE 3; 3.2 g/40g; g/40g 68479-000_7d487462-89bc-4a73-989d-cad0eae0614f 68479-000 HUMAN OTC DRUG Solar Defense Booster SPF50 Avobenzone and Octinoxate LOTION TOPICAL 20120213 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE; OCTINOXATE 30; 70 mg/mL; mg/mL 68479-013_fea6881c-3e18-4da6-8232-a460c3e4d7ce 68479-013 HUMAN OTC DRUG Sebum Clearing Masque Salicylic Acid LOTION TOPICAL 20110513 OTC MONOGRAPH FINAL part358H Dermalogica SALICYLIC ACID 5 mg/mL 68479-040_46138481-0e29-406e-80a7-bab174f0f195 68479-040 HUMAN OTC DRUG Clearing Skin Wash Salicylic Acid LIQUID TOPICAL 20091230 OTC MONOGRAPH FINAL part358H Dermalogica, Inc. SALICYLIC ACID 5 mg/mL 68479-101_823154b8-06d2-4909-ab27-24481023fa7c 68479-101 HUMAN OTC DRUG Breakout Clearing Foaming Wash Salicylic Acid LIQUID TOPICAL 20130513 OTC MONOGRAPH FINAL part358H Dermalogica SALICYLIC ACID 5 mg/mL 68479-110_f9a1752f-92c2-448e-b13b-8616e20ea211 68479-110 HUMAN OTC DRUG Oil Free Matte SPF 30 Avobenzone, Homosalate, Octisalate, and Oxybenzone LOTION TOPICAL 20120216 OTC MONOGRAPH FINAL part352 Dermalogica AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 30; 80; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL 68479-116_a0667aa0-90f7-4c4b-9488-99c2e0facbb4 68479-116 HUMAN OTC DRUG Concealing Spot Treatment Sulfur LOTION TOPICAL 20101005 OTC MONOGRAPH FINAL part358H Dermalogica, Inc. SULFUR 50 mg/mL 68479-120_c381475c-62e6-4d59-9934-04eb3e01b72c 68479-120 HUMAN OTC DRUG UltraSensitive Tint SPF 30 Titanium Dioxide LOTION TOPICAL 20120314 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. TITANIUM DIOXIDE 110 mg/mL 68479-130_2408bb22-2617-4a16-acf4-5bb3039f9d6c 68479-130 HUMAN OTC DRUG SkinPerfect Primer SPF 30 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20120213 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. TITANIUM DIOXIDE; ZINC OXIDE 40; 140 mg/mL; mg/mL 68479-140_539d880a-3bfd-4912-af64-4efe8b8bd3ec 68479-140 HUMAN OTC DRUG Oil Clearing Matte Moisturizer Avobenzone, Octinoxate, OXYBENZONE, and Octisalate LOTION TOPICAL 20130829 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 25; 60; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL 68479-150_b41fdde8-89c5-4231-a1b6-f95528952998 68479-150 HUMAN OTC DRUG Super Sensitive Shield SPF 30 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20120305 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. TITANIUM DIOXIDE; ZINC OXIDE 70; 90 mg/mL; mg/mL 68479-160_31e69885-5f3f-4bcc-b62c-f2752d5dc63f 68479-160 HUMAN OTC DRUG Breakout Clearing Daytime Treatment Benzoyl Peroxide LOTION TOPICAL 20130604 OTC MONOGRAPH FINAL part333D Dermalogica, Inc. BENZOYL PEROXIDE 25 mg/mL 68479-200_dfbbafcf-cdd3-42d7-9b26-144039c17de8 68479-200 HUMAN OTC DRUG Sheer Tint SPF20 - Light Zinc Oxide and Octinoxate LOTION TOPICAL 20120901 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. OCTINOXATE; ZINC OXIDE 45; 95 mg/mL; mg/mL 68479-202_a428575c-cefa-4f1d-8712-faf36371ae8c 68479-202 HUMAN OTC DRUG Breakout Clearing Emergency Spot Fix Benzoyl Peroxide LOTION TOPICAL 20130603 OTC MONOGRAPH FINAL part333D Dermalogica, Inc. BENZOYL PEROXIDE 50 mg/mL 68479-216_19d3e75e-5c85-48a7-bdae-57f0e6ef4517 68479-216 HUMAN OTC DRUG Redness Relief SPF 20 Octinoxate and Zinc Oxide LOTION TOPICAL 20120411 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. OCTINOXATE; ZINC OXIDE 50; 55 mg/mL; mg/mL 68479-220_8bef6340-4330-4617-84ea-98d85da9566d 68479-220 HUMAN OTC DRUG Cover Tint SPF 20 - Light Avobenzone, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20120427 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 70; 40; 40 mg/mL; mg/mL; mg/mL; mg/mL 68479-230_f245ca49-37d6-4fee-9d1a-bbf838030c47 68479-230 HUMAN OTC DRUG Protection 50 Body Avobenzone and Octinoxate LOTION TOPICAL 20130808 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE; OCTINOXATE 30; 75 mg/mL; mg/mL 68479-300_dfbbafcf-cdd3-42d7-9b26-144039c17de8 68479-300 HUMAN OTC DRUG Sheer Tint SPF20 - Dark Zinc Oxide and Octinoxate LOTION TOPICAL 20120901 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. OCTINOXATE; ZINC OXIDE 45; 95 mg/mL; mg/mL 68479-312_dae6a0bd-aebb-45af-bc39-07db70052c10 68479-312 HUMAN OTC DRUG Breakout Clearing All Over Toner Salicylic Acid LIQUID TOPICAL 20130905 OTC MONOGRAPH FINAL part358H Dermalogica, Inc. SALICYLIC ACID 10 mg/mL 68479-313_1278f223-284b-4de2-a570-b7fb0394aa41 68479-313 HUMAN OTC DRUG Breakout Clearing Overnight Treatment Salicylic Acid LOTION TOPICAL 20130906 OTC MONOGRAPH FINAL part358H Dermalogica, Inc. SALICYLIC ACID 20 mg/mL 68479-318_caf8ab2d-70d2-4ae7-9065-baaaf1c85902 68479-318 HUMAN OTC DRUG Dynamic Skin Recovery SPF 50 Avobenzone and Octinoxate LOTION TOPICAL 20131209 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE; OCTINOXATE 30; 75 mg/mL; mg/mL 68479-360_8296bbf4-b9ea-4037-ab3c-9a9458575188 68479-360 HUMAN OTC DRUG Total Eye Care SPF 15 Titanium Dioxide LOTION TOPICAL 20120329 OTC MONOGRAPH FINAL part352 Dermalogica TITANIUM DIOXIDE 45 mg/mL 68479-400_8bef6340-4330-4617-84ea-98d85da9566d 68479-400 HUMAN OTC DRUG Cover Tint SPF 20 - Medium Avobenzone, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20120427 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 70; 40; 40 mg/mL; mg/mL; mg/mL; mg/mL 68479-411_7d4209a2-c13b-453b-a239-91bf683adb61 68479-411 HUMAN OTC DRUG Clearing Mattifier Salicylic Acid LOTION TOPICAL 20090417 OTC MONOGRAPH FINAL part358H Dermalogica, Inc. SALICYLIC ACID 20 mg/mL 68479-412_e0c857a8-e943-41b0-8241-4313c4451d2e 68479-412 HUMAN OTC DRUG Dynamic Skin Recovery SPF 30 Avobenzone, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20090428 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL 68479-500_1b6ecbbe-bb23-44b1-b839-f7abfbfd282c 68479-500 HUMAN OTC DRUG Breakout Clearing Cooling Masque Salicylic Acid LOTION TOPICAL 20130918 OTC MONOGRAPH FINAL part358H Dermalogica, Inc. SALICYLIC ACID 20 mg/mL 68479-503_bf5b7df5-2e8c-45e3-85fa-9f2d40d74beb 68479-503 HUMAN OTC DRUG Special Clearing Booster Benzoyl Peroxide LIQUID TOPICAL 20110922 OTC MONOGRAPH FINAL part333D Dermalogica, Inc. BENZOYL PEROXIDE 50 mg/mL 68479-600_8bef6340-4330-4617-84ea-98d85da9566d 68479-600 HUMAN OTC DRUG Cover Tint SPF 20 - Dark Avobenzone, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20120427 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 70; 40; 40 mg/mL; mg/mL; mg/mL; mg/mL 68479-700_c91f05b9-ef2f-4046-95ad-44ad29f85188 68479-700 HUMAN OTC DRUG PureLight SPF 30 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20080307 OTC MONOGRAPH FINAL part352 Dermalogica TITANIUM DIOXIDE; ZINC OXIDE 62; 85 mg/mL; mg/mL 68479-706_45650f2d-f580-4f29-9e00-c48028fbe0e7 68479-706 HUMAN OTC DRUG Overnight Clearing Salicylic Acid GEL TOPICAL 20070501 OTC MONOGRAPH FINAL part358H Dermalogica, Inc. SALICYLIC ACID 20 mg/mL 68479-800_c9c4b1e1-6886-4726-8f13-b06f083983f6 68479-800 HUMAN OTC DRUG Daily Defense SPF 15 Avobenzone, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20120413 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 65; 30; 35 mg/mL; mg/mL; mg/mL; mg/mL 68479-804_3e46cffd-252e-42f0-9bf2-d4f073215041 68479-804 HUMAN OTC DRUG MediBac Clearing Complex Salicylic Acid LIQUID TOPICAL 20070509 OTC MONOGRAPH FINAL part358H Dermalogica, Inc. SALICYLIC ACID 5 mg/mL 68479-808_48ad2b83-d8e8-4d12-bf6a-cc5e2338fd17 68479-808 HUMAN OTC DRUG Oil Control Salicylic Acid LOTION TOPICAL 20031204 OTC MONOGRAPH FINAL part358H Dermalogica, Inc. SALICYLIC ACID 10 mg/mL 68479-900_dfbbafcf-cdd3-42d7-9b26-144039c17de8 68479-900 HUMAN OTC DRUG Sheer Tint SPF20 - Medium Zinc Oxide and Octinoxate LOTION TOPICAL 20120901 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. OCTINOXATE; ZINC OXIDE 45; 95 mg/mL; mg/mL 68511-350_0588618d-ba35-4588-a6f6-bba696427df2 68511-350 HUMAN OTC DRUG Mayinglong Hemorrhoids Zinc Oxide SUPPOSITORY RECTAL 20090715 OTC MONOGRAPH FINAL part346 Mayinglong Pharmaceutical Group Co., Ltd ZINC OXIDE 1.7 g/1 68511-360_2995e63f-48a0-4593-b7dd-523ae49f7f3c 68511-360 HUMAN OTC DRUG MAYINGLONG HEMORRHOIDS Zinc Oxide, Petrolatum, Lanolin OINTMENT TOPICAL 20031215 OTC MONOGRAPH FINAL part346 Mayinglong Pharmaceutical Group Co Ltd LANOLIN; PETROLATUM; ZINC OXIDE 500; 7850; 350 mg/10000mg; mg/10000mg; mg/10000mg 68511-460_d23c7ca8-4e63-4162-88fb-8c463ffb4b81 68511-460 HUMAN OTC DRUG Licorice Coughing Liquid Guaifenesin LIQUID ORAL 20031215 OTC MONOGRAPH FINAL part341 Mayinglong Pharmaceutical Group Co., Ltd GUAIFENESIN 5 g/100mL 68515-001_45710f8c-3d88-4154-b790-4b0698cb0013 68515-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20110103 UNAPPROVED MEDICAL GAS American Home Respiratory Care, Inc. OXYGEN 992 mL/L 68516-3201_80980169-caa0-483b-83a6-d31db7317120 68516-3201 PLASMA DERIVATIVE Profilnine factor ix complex KIT INTRAVENOUS 19810720 BLA BLA102476 GRIFOLS USA, LLC 68516-3202_80980169-caa0-483b-83a6-d31db7317120 68516-3202 PLASMA DERIVATIVE Profilnine factor ix complex KIT INTRAVENOUS 19810720 BLA BLA102476 GRIFOLS USA, LLC 68516-3203_80980169-caa0-483b-83a6-d31db7317120 68516-3203 PLASMA DERIVATIVE Profilnine factor ix complex KIT INTRAVENOUS 19810720 BLA BLA102476 GRIFOLS USA, LLC 68516-3601_17a172a4-b1ae-438c-88c3-d1d663fd77a7 68516-3601 PLASMA DERIVATIVE AlphaNine SD COAGULATION FACTOR IX (HUMAN) KIT INTRAVENOUS 19901231 BLA BLA103249 GRIFOLS USA, LLC 68516-3602_17a172a4-b1ae-438c-88c3-d1d663fd77a7 68516-3602 PLASMA DERIVATIVE AlphaNine SD COAGULATION FACTOR IX (HUMAN) KIT INTRAVENOUS 19901231 BLA BLA103249 GRIFOLS USA, LLC 68516-3603_17a172a4-b1ae-438c-88c3-d1d663fd77a7 68516-3603 PLASMA DERIVATIVE AlphaNine SD COAGULATION FACTOR IX (HUMAN) KIT INTRAVENOUS 19901231 BLA BLA103249 GRIFOLS USA, LLC 68516-4601_2cf60103-1ae7-4187-84ca-6e1cea458e02 68516-4601 PLASMA DERIVATIVE Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human) KIT INTRAVENOUS 20070131 BLA BLA102475 GRIFOLS USA, LLC 68516-4602_2cf60103-1ae7-4187-84ca-6e1cea458e02 68516-4602 PLASMA DERIVATIVE Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human) KIT INTRAVENOUS 20070131 BLA BLA102475 GRIFOLS USA, LLC 68516-4603_2cf60103-1ae7-4187-84ca-6e1cea458e02 68516-4603 PLASMA DERIVATIVE Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human) KIT INTRAVENOUS 20070131 BLA BLA102475 GRIFOLS USA, LLC 68516-4604_2cf60103-1ae7-4187-84ca-6e1cea458e02 68516-4604 PLASMA DERIVATIVE Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human) KIT INTRAVENOUS 20070131 BLA BLA102475 GRIFOLS USA, LLC 68516-4609_2cf60103-1ae7-4187-84ca-6e1cea458e02 68516-4609 PLASMA DERIVATIVE Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human) KIT INTRAVENOUS 20140930 BLA BLA102475 GRIFOLS USA, LLC 68516-5214_6cf5ee08-0ee4-4282-9d06-069c1527c377 68516-5214 PLASMA DERIVATIVE Albutein Albumin (Human) INJECTION, SOLUTION INTRAVENOUS 19780815 BLA BLA102478 GRIFOLS USA, LLC ALBUMIN (HUMAN) 12.5 g/250mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 68516-5215_4a5d42cb-c554-43fa-92ac-18a481877e81 68516-5215 PLASMA DERIVATIVE Albutein Albumin (Human) INJECTION, SOLUTION INTRAVENOUS 19780815 BLA BLA102478 GRIFOLS USA, LLC ALBUMIN (HUMAN) 10 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 68516-5216_4e974ba8-0ea5-4019-86c4-027ad6e7ce8c 68516-5216 PLASMA DERIVATIVE Albutein Albumin (Human) INJECTION, SOLUTION INTRAVENOUS 19780815 BLA BLA102478 GRIFOLS USA, LLC ALBUMIN (HUMAN) 12.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 68540-001_04e8930d-c3e2-46d0-96b6-feb5d28e9b35 68540-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020101 UNAPPROVED MEDICAL GAS Price Rite Medical Equipment, Inc. OXYGEN 990 mL/L 68546-142_90b04c60-03b0-4e85-8ec3-591362f22e11 68546-142 HUMAN PRESCRIPTION DRUG Azilect Rasagiline Mesylate TABLET ORAL 20060710 NDA NDA021641 Teva Neuroscience, Inc. RASAGILINE MESYLATE .5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] 68546-229_90b04c60-03b0-4e85-8ec3-591362f22e11 68546-229 HUMAN PRESCRIPTION DRUG Azilect Rasagiline Mesylate TABLET ORAL 20060710 NDA NDA021641 Teva Neuroscience, Inc. RASAGILINE MESYLATE 1 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] 68546-317_35322042-4933-46b4-9cd5-5f29cd3d3b9e 68546-317 HUMAN PRESCRIPTION DRUG COPAXONE glatiramer acetate INJECTION, SOLUTION SUBCUTANEOUS 20080428 NDA NDA020622 Teva Neuroscience, Inc. GLATIRAMER ACETATE 20 mg/mL 68546-325_35322042-4933-46b4-9cd5-5f29cd3d3b9e 68546-325 HUMAN PRESCRIPTION DRUG COPAXONE glatiramer acetate INJECTION, SOLUTION SUBCUTANEOUS 20140129 NDA NDA020622 Teva Neuroscience, Inc. GLATIRAMER ACETATE 40 mg/mL 68570-704_3cc600e6-ec61-4d17-8065-66ed3615e41f 68570-704 HUMAN OTC DRUG shu uemura UV underbase SPF 20 sunscreen Octinoxate Titanium Dioxide LIQUID TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part352 Cosmelor Ltd OCTINOXATE; TITANIUM DIOXIDE .84; 1.428 mL/28mL; mL/28mL 68570-744_59a7f077-a60a-4383-be34-5a0788848d87 68570-744 HUMAN OTC DRUG shu uemura UV under base mousse SPF 30 sunscreen Octinoxate Octisalate Octocrylene Titanium Dioxide AEROSOL, FOAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 Cosmelor Ltd OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 4.6; 3.1; 1.9; 3.1 g/65g; g/65g; g/65g; g/65g 68570-812_2cf51200-e9b6-4138-8270-6596371f6c73 68570-812 HUMAN OTC DRUG shu uemura face architect glow enhancing foundation SPF 26 Octinoxate Zinc Oxide POWDER TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 Cosmelor Ltd OCTINOXATE; ZINC OXIDE .8; .48 g/14g; g/14g 68572-3004_9ff93dcb-3487-465c-aed0-a0551d1f740d 68572-3004 HUMAN OTC DRUG Karavita Face Essential with SPF 15 Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20040101 OTC MONOGRAPH FINAL part352 Kara Vita, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 3; 5 g/59mL; g/59mL; g/59mL 68572-4004_dcb3d9ca-11c9-47b9-b9fa-83417d886d3a 68572-4004 HUMAN OTC DRUG Enlighten Me Hydroquinone LOTION TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part358A Kara Vita, Inc. HYDROQUINONE 2 g/14.25g 68572-4014_215f6cfa-8790-4f6e-b225-e47b49b64e78 68572-4014 HUMAN OTC DRUG Clearly It Salicylic Acid LOTION TOPICAL 20040101 OTC MONOGRAPH FINAL part358 Kara Vita, Inc. SALICYLIC ACID .5 g/59g 68572-6005_92f9fc14-74c4-4e2a-a0bc-b7a13121a51c 68572-6005 HUMAN OTC DRUG All Day Sunscreen with SPF 30 Oxybenzone, Octinoxate, Octisalate, and Homosalate LOTION TOPICAL 20040101 OTC MONOGRAPH FINAL part352 Kara Vita, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 5.9; 8.9; 5.9; 8.9 g/118mL; g/118mL; g/118mL; g/118mL 68572-6007_34b7ba5f-84e4-406a-8850-9fd0d3053cbd 68572-6007 HUMAN OTC DRUG Parsol Suncare SPF 29 Oxybenzone, Octinoxate, Octisalate, Homosalate, and Avobenzone LOTION TOPICAL 20040101 OTC MONOGRAPH FINAL part352 Kara Vita, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.4; 5.9; 8.9; 5.9; 5.9 g/118mL; g/118mL; g/118mL; g/118mL; g/118mL 68599-0123_1499cdee-5168-4659-a5d3-2a0c49da1d04 68599-0123 HUMAN OTC DRUG McKesson Fluoride Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20120217 OTC MONOGRAPH FINAL part355 McKesson Medical-Surgical SODIUM MONOFLUOROPHOSPHATE 2.43 mg/g 68599-0201_05a1cbda-54a2-4b83-ab91-4993dad37f0d 68599-0201 HUMAN OTC DRUG THERA Antimicrobial Body Cleanser Benzalkonium Chloride LIQUID TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333E McKesson Medical-Surgical Inc. BENZALKONIUM CHLORIDE 1.3 uL/mL 68599-0202_5f1ea385-208a-4b71-9726-c621d01a5ae6 68599-0202 HUMAN OTC DRUG THERA Moisturizing Body Cleanser Dimethicone LIQUID TOPICAL 20110901 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical Inc. DIMETHICONE 17.5 uL/mL 68599-0203_03cadffe-c466-417e-9bae-eb26381da4e0 68599-0203 HUMAN OTC DRUG THERA Dimethicone Body Shield Dimethicone CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical Inc. DIMETHICONE 50 uL/mL 68599-0204_365bb9ee-b1ee-4ee2-8c39-d107b15debaf 68599-0204 HUMAN OTC DRUG THERA Moisturizing Body Shield Dimethicone CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical Inc. DIMETHICONE 15 mg/g 68599-0205_12014396-6d05-40ed-a3c7-f60712562a32 68599-0205 HUMAN OTC DRUG THERA Calazinc Body Shield Zinc Oxide PASTE TOPICAL 20110901 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical Inc. ZINC OXIDE 200 mg/g 68599-0207_d7593af7-3af3-4e78-b62f-8afcfeba72cf 68599-0207 HUMAN OTC DRUG THERA Antifungal Body Miconazole Nitrate POWDER TOPICAL 20110901 OTC MONOGRAPH FINAL part333C McKesson Medical-Surgical Inc. MICONAZOLE NITRATE 20 mg/g 68599-0208_1e65e502-5c19-4837-ad6b-14fbf70de191 68599-0208 HUMAN OTC DRUG THERA Moisturizing Body Dimethicone CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical Inc. DIMETHICONE 17.5 uL/mL 68599-1180_eee7be86-80e9-4367-bfd2-6d885471145f 68599-1180 HUMAN OTC DRUG McKesson Vitamin A and D Petrolatum OINTMENT TOPICAL 20111201 OTC MONOGRAPH FINAL part347 McKesson Medical Surgical, Inc. PETROLATUM 937.5 mg/g 68599-2301_69fead9f-b393-4f40-b86b-c8a4a7c47b30 68599-2301 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20131009 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical Inc. HYDROGEN PEROXIDE 30 mg/mL 68599-2302_0a3f928a-15af-4282-8a91-201bf4b23287 68599-2302 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20131009 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical Inc. ISOPROPYL ALCOHOL 700 mg/mL 68599-2303_5b00b568-1cc0-4964-a526-b70e3ebdcf9a 68599-2303 HUMAN OTC DRUG Roll On Anti-Perspirant (Alcohol Free) ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20130805 OTC MONOGRAPH FINAL part350 McKesson Medical-Surgical, Inc. ALUMINUM CHLOROHYDRATE .1 mg/mL 68599-2304_c53a023c-8c0b-4d7b-8611-dda33a5a3c46 68599-2304 HUMAN OTC DRUG Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE SPRAY TOPICAL 20131009 OTC MONOGRAPH FINAL part350 McKesson Medical-Surgical Inc. ALUMINUM CHLOROHYDRATE 130 mg/mL 68599-2305_28e51c76-4963-4b88-804e-39683264c9e2 68599-2305 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20131114 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical Inc. HYDROGEN PEROXIDE 30 mg/mL 68599-2306_1340886c-3017-498a-9804-e1f3647f586e 68599-2306 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20131114 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical Inc. ISOPROPYL ALCOHOL 700 mg/mL 68599-5301_046a724b-94d8-4b2d-92ef-04fa51aca16e 68599-5301 HUMAN OTC DRUG Mckesson Antimicrobial Hand Triclosan SOAP TOPICAL 20030101 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical Inc. TRICLOSAN 3.75 mg/mL 68599-5302_538fa98f-82ae-4f68-9c01-c3e24ea8b644 68599-5302 HUMAN OTC DRUG McKesson Antimicrobial Hand Triclosan SOAP TOPICAL 20140502 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical Inc. TRICLOSAN 3.75 mg/mL 68599-5303_696c9d7c-6d15-4826-afb6-8b1a3b4f113b 68599-5303 HUMAN OTC DRUG Medi-Pak Performance Antimicrobial with Aloe CHLOROXYLENOL SOAP TOPICAL 20030101 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical Inc. CHLOROXYLENOL .95 mL/100mL 68599-5306_cf5b1a1c-3786-4259-872d-ae92a23401a5 68599-5306 HUMAN OTC DRUG Medi-Pak Performance Instant Hand Sanitizer Alcohol GEL TOPICAL 20030101 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical Inc. ALCOHOL 64.5 mL/100mL 68599-5309_0cb64d73-9c20-469b-a6b9-d3bf4cb44e48 68599-5309 HUMAN OTC DRUG Medi-Pak Performance Instant Hand Sanitizer with Aloe Alcohol GEL TOPICAL 20030101 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical Inc. ALCOHOL 64.5 mL/100mL 68599-5312_797bf710-5d68-4cc3-a9b0-81eff4556d99 68599-5312 HUMAN OTC DRUG McKesson Skin Protectant ZINC OXIDE CREAM TOPICAL 20140424 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical Inc. ZINC OXIDE 50 mg/mL 68599-5804_aa85684d-5391-4442-8a9c-b2964e4eea90 68599-5804 HUMAN OTC DRUG McKesson Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20100409 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical ISOPROPYL ALCOHOL .7 mL/mL 68599-6103_a29c9af0-87d1-4212-a429-ba11e14e6d73 68599-6103 HUMAN OTC DRUG DERMA GRAN Aluminium Hydroxide OINTMENT TOPICAL 20131112 OTC MONOGRAPH FINAL part331 McKesson Medical-Surgical ALUMINUM HYDROXIDE .275 g/100g 68599-6105_e2716b5a-efd4-4ed0-bfa3-1c47010b2f9a 68599-6105 HUMAN OTC DRUG DERMA GRAN BC PERINEAL PROTECTANT Zinc Oxide, Petrolatum OINTMENT TOPICAL 20131112 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical PETROLATUM; ZINC OXIDE 30; 20 g/100g; g/100g 68599-6106_2661f0c4-16bb-421c-9fd4-7623a1e31499 68599-6106 HUMAN OTC DRUG DERMA GRAN GP Petrolatum OINTMENT TOPICAL 20131112 OTC MONOGRAPH FINAL part346 McKesson Medical-Surgical PETROLATUM 85 g/100g 68599-6109_daf497d0-c518-488a-b1a8-46513dbe96dd 68599-6109 HUMAN OTC DRUG MEDI-PAK Zinc Oxide DRESSING TOPICAL 20100805 OTC MONOGRAPH FINAL part347 MCKESSON MEDICAL-SURGICAL ZINC OXIDE 25 g/1 68599-6110_d6649b1c-33bb-4daa-85e4-d5a0a33d9c6b 68599-6110 HUMAN OTC DRUG MEDI-PAK Zinc Oxide, Calamine DRESSING TOPICAL 20100805 OTC MONOGRAPH FINAL part347 MCKESSON MEDICAL-SURGICAL FERRIC OXIDE RED; ZINC OXIDE; ZINC OXIDE .015; .985; 25 g/1; g/1; g/1 68599-6111_4f802dd8-3790-4cc0-a08e-d5b683ae888a 68599-6111 HUMAN OTC DRUG McKesson Unna Boot 3 Zinc Oxide DRESSING TOPICAL 20140701 OTC MONOGRAPH FINAL part346 McKesson Medical-Surgical ZINC OXIDE 19.8 g/165g 68599-6112_a6f4cd2e-1c48-4210-ab34-952051d1e9c1 68599-6112 HUMAN OTC DRUG McKesson Unna Boot with Calamine 3 Zinc Oxide and Ferric Oxide Red DRESSING TOPICAL 20140701 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical FERRIC OXIDE RED; ZINC OXIDE .35; 4.95 g/165g; g/165g 68599-6113_4f802dd8-3790-4cc0-a08e-d5b683ae888a 68599-6113 HUMAN OTC DRUG McKesson Unna Boot 4 Zinc Oxide DRESSING TOPICAL 20140701 OTC MONOGRAPH FINAL part346 McKesson Medical-Surgical ZINC OXIDE 24.6 g/205g 68599-6114_a6f4cd2e-1c48-4210-ab34-952051d1e9c1 68599-6114 HUMAN OTC DRUG McKesson Unna Boot with Calamine 4 Zinc Oxide and Ferric Oxide Red DRESSING TOPICAL 20140701 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical FERRIC OXIDE RED; ZINC OXIDE .43; 6.15 g/205g; g/205g 68604-023_96793af4-13d0-46af-ae70-d7d52c696a53 68604-023 HUMAN OTC DRUG Hand Kleen Premium Antibacterial Hand Triclosan SOAP TOPICAL 20130322 OTC MONOGRAPH NOT FINAL part333A Auto-Chlor System, LLC TRICLOSAN .3 g/100mL 68604-231_bb2d97f7-e71c-4cde-8ee0-85c13a6a23ed 68604-231 HUMAN OTC DRUG Hand Kleen Foaming Antibacterial Hand Triclosan LIQUID TOPICAL 20121217 OTC MONOGRAPH NOT FINAL part333A Auto-Chlor System, LLC TRICLOSAN .3 g/100mL 68604-235_a3ea5c6e-0691-4450-bcbe-db8a01295308 68604-235 HUMAN OTC DRUG Hand Kleen Golden Touch Antibacterial Hand Cleanser Triclosan LIQUID TOPICAL 20121220 OTC MONOGRAPH NOT FINAL part333A Auto-Chlor System, LLC TRICLOSAN .5 g/100mL 68604-237_a5509979-d2b3-41eb-b16a-c5f6d12e1242 68604-237 HUMAN OTC DRUG Hand Kleen Foaming Instant Hand Sanitizer Benzethonium Chloride LIQUID TOPICAL 20121231 OTC MONOGRAPH NOT FINAL part333E Auto-Chlor System, LLC BENZETHONIUM CHLORIDE .2 g/100mL 68604-238_51ad68f1-0d1b-4c1d-9fac-be0531e2361b 68604-238 HUMAN OTC DRUG Hand Kleen Southern OrchardAntibacterial Han Antibacterial Hand Cleanser Triclosan SOAP TOPICAL 20140804 OTC MONOGRAPH NOT FINAL part333A Auto-Chlor System, LLC TRICLOSAN .3 g/100mL 68605-2001_f21b567e-7251-4ab4-ad90-bce91c9c721e 68605-2001 HUMAN OTC DRUG END-ZIT SULFUR LOTION, AUGMENTED TOPICAL 20040420 OTC MONOGRAPH FINAL part333D ABBE Laboratories, Inc. SULFUR .05 g/mL 68605-2002_f21b567e-7251-4ab4-ad90-bce91c9c721e 68605-2002 HUMAN OTC DRUG END-ZIT SULFUR LOTION, AUGMENTED TOPICAL 20040420 OTC MONOGRAPH FINAL part333D ABBE Laboratories, Inc. SULFUR .05 g/g 68605-2003_f21b567e-7251-4ab4-ad90-bce91c9c721e 68605-2003 HUMAN OTC DRUG END-ZIT SULFUR LOTION, AUGMENTED TOPICAL 20040420 OTC MONOGRAPH FINAL part333D ABBE Laboratories, Inc. SULFUR .05 g/g 68605-2006_f21b567e-7251-4ab4-ad90-bce91c9c721e 68605-2006 HUMAN OTC DRUG END-ZIT SULFUR LOTION, AUGMENTED TOPICAL 20040420 OTC MONOGRAPH FINAL part333D ABBE Laboratories, Inc. SULFUR .05 g/g 68609-575_5b0775d8-0e68-44cc-8b9f-c7597d35d5a4 68609-575 HUMAN OTC DRUG Sani-Foam Instant Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20040131 OTC MONOGRAPH NOT FINAL part333 General Products & Supply, Inc. BENZETHONIUM CHLORIDE 2 mg/mL 68611-190_7e9f69be-77a9-4b2d-843f-9e094ac3f9f6 68611-190 HUMAN PRESCRIPTION DRUG Iluvien fluocinolone acetonide IMPLANT INTRAVITREAL 20141015 NDA NDA201923 Alimera Sciences, Inc. FLUOCINOLONE ACETONIDE .19 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68624-001_d53ffba8-cd95-4923-8043-d64cfe582947 68624-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040101 UNAPPROVED MEDICAL GAS Tech Air of Naugatuck LLC OXYGEN 990 mL/L 68624-002_f3ee5a93-9e83-40c1-9e33-3b85cfee028b 68624-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20051201 UNAPPROVED MEDICAL GAS Tech Air of Naugatuck, LLC NITROGEN 990 mL/L 68628-500_3c409f54-abda-4ee4-8393-497c71c04fd4 68628-500 HUMAN PRESCRIPTION DRUG SURFAXIN lucinactant SUSPENSION ENDOTRACHEAL 20131101 NDA NDA021746 Discovery Laboratories, Inc. 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-(PHOSPHO-RAC-(1-GLYCEROL)), SODIUM SALT; COLFOSCERIL PALMITATE; PALMITIC ACID; SINAPULTIDE 7.5; 22.5; 4.05; .862 mg/mL; mg/mL; mg/mL; mg/mL 68634-0029_2a94857e-50e3-48f6-bfbc-25ac68d6ae5b 68634-0029 HUMAN OTC DRUG age renewal deep wrinkle moisturizer Homosalate, Octisalate, Oxybenzone, Avobenzone, Octocrylene CREAM TOPICAL 20100112 OTC MONOGRAPH FINAL part352 AMCOL Health and Beauty Solutions, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .02; .1; .05; .015; .02 g/g; g/g; g/g; g/g; g/g 68634-0031_3d6d5909-5da6-4436-a39a-e7a3a2a3986e 68634-0031 HUMAN OTC DRUG age renewal firming and hydrating moisturizer Octinoxate, Octisalate, Oxybenzone, Zinc Oxide CREAM TOPICAL 20091222 OTC MONOGRAPH FINAL part352 AMCOL Health and Beauty Solutions, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .075; .05; .04; .02 g/g; g/g; g/g; g/g 68634-0032_e8bc0518-5921-4505-99fc-b8c4f30b58c6 68634-0032 HUMAN OTC DRUG Glycolic Day Cream SPF 30 Homosalate, Octisalate, Octocrylene, Oxybenzone, Avobenzone CREAM TOPICAL 20100104 OTC MONOGRAPH FINAL part352 AMCOL Health and Beauty Solutions, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .1; .05; .02; .05 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL 68639-0001_a2b0d552-5eba-4be3-9c34-5065f39814d9 68639-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20031013 UNAPPROVED MEDICAL GAS RX O2 Oxygen & Medical Equipment Supply OXYGEN 99 L/100L 68642-783_9db5510f-c646-48f6-8389-f38a5e6a6aa0 68642-783 HUMAN OTC DRUG Sani Wipes ALCOHOL CLOTH TOPICAL 20090801 OTC MONOGRAPH NOT FINAL part333 Omega Industrial Supply, Inc. ALCOHOL 620 mg/g 68645-020_f1102345-7a13-47d3-b7bc-8686b7ef5729 68645-020 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20110209 ANDA ANDA062505 Legacy Pharmaceutical Packaging DOXYCYCLINE HYCLATE 100 mg/1 68645-021_af206cfa-2d91-49e2-b60d-90a7348fb706 68645-021 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20100501 ANDA ANDA065095 Legacy Pharmaceutical Packaging DOXYCYCLINE HYCLATE 100 mg/1 68645-060_c87b05a1-82c0-4e4a-b144-6ef0e5665dd4 68645-060 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED ORAL 20110412 ANDA ANDA075817 Legacy Pharmaceutical Packaging CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68645-130_c59509bb-034c-467c-891e-c6b631a7d8bd 68645-130 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20110125 ANDA ANDA076001 Legacy Pharmaceutical Packaging FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68645-131_daac9d5a-3f33-4005-abac-659cb96fc5e9 68645-131 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20110131 ANDA ANDA076001 Legacy Pharmaceutical Packaging FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68645-140_9663b28a-e796-4417-9023-3a5d17fc1e1e 68645-140 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20091026 ANDA ANDA075511 Legacy Pharmaceutical Packaging FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68645-141_9663b28a-e796-4417-9023-3a5d17fc1e1e 68645-141 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20091026 ANDA ANDA075511 Legacy Pharmaceutical Packaging FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68645-150_42dddd23-5dea-4f56-881a-54008397e2d9 68645-150 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Legacy Pharmaceutical Packaging GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68645-151_42dddd23-5dea-4f56-881a-54008397e2d9 68645-151 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Legacy Pharmaceutical Packaging GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68645-160_20fd1a9b-ba61-4258-a38e-8d4f570f5831 68645-160 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090911 ANDA ANDA074532 Legacy Pharmaceutical Packaging CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68645-161_20fd1a9b-ba61-4258-a38e-8d4f570f5831 68645-161 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090911 ANDA ANDA074532 Legacy Pharmaceutical Packaging CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68645-162_20fd1a9b-ba61-4258-a38e-8d4f570f5831 68645-162 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090911 ANDA ANDA074532 Legacy Pharmaceutical Packaging CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68645-163_20fd1a9b-ba61-4258-a38e-8d4f570f5831 68645-163 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090911 ANDA ANDA074532 Legacy Pharmaceutical Packaging CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68645-190_14addbac-cc1a-423b-ac39-3e686ccfe789 68645-190 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Legacy Pharmaceutical Packaging METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68645-191_14addbac-cc1a-423b-ac39-3e686ccfe789 68645-191 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Legacy Pharmaceutical Packaging METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68645-201_16e8cce7-e7db-4be9-8a68-b3f762a12047 68645-201 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Legacy Pharmaceutical Packaging POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68645-202_16e8cce7-e7db-4be9-8a68-b3f762a12047 68645-202 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Legacy Pharmaceutical Packaging POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 68645-210_a7ef3595-91e6-4f96-964d-4542a8758a89 68645-210 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20100518 NDA AUTHORIZED GENERIC NDA017532 Legacy Pharmaceutical Packaging GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68645-211_a7ef3595-91e6-4f96-964d-4542a8758a89 68645-211 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20100518 20150331 NDA AUTHORIZED GENERIC NDA017532 Legacy Pharmaceutical Packaging GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68645-220_9c369d7e-f0e8-4fb4-9faa-efdd346ec50e 68645-220 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20081120 20150831 ANDA ANDA075682 Legacy Pharmaceutical Packaging IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68645-221_9c369d7e-f0e8-4fb4-9faa-efdd346ec50e 68645-221 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20081120 20150831 ANDA ANDA075682 Legacy Pharmaceutical Packaging IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68645-222_9c369d7e-f0e8-4fb4-9faa-efdd346ec50e 68645-222 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20081120 20150930 ANDA ANDA075682 Legacy Pharmaceutical Packaging IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68645-230_cd548efc-2b66-414b-b8b5-d9f60d122a86 68645-230 HUMAN PRESCRIPTION DRUG Belladonna Alkaloids with Phenobartbital Belladonna Alkaloids with Phenobartbital TABLET ORAL 20001201 UNAPPROVED DRUG OTHER Legacy Pharmaceutical Packaging ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE .0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 68645-252_697f72ae-d7fb-4736-953a-685027b03f9b 68645-252 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET ORAL 20100430 ANDA ANDA077289 Legacy Pharmaceutical Packaging CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68645-261_7ca18492-8ba1-4b24-97b3-fec147799031 68645-261 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20101001 ANDA ANDA077752 Legacy Pharmaceutical Packaging SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-262_7ca18492-8ba1-4b24-97b3-fec147799031 68645-262 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20101001 ANDA ANDA077752 Legacy Pharmaceutical Packaging SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-263_82a864ad-1652-405f-bbfa-b8ece0089165 68645-263 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Legacy Pharmaceutical Packaging SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-272_6ef589c7-9309-4f1c-8bf0-c1548636acc3 68645-272 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20101001 ANDA ANDA076059 Legacy Pharmaceutical Packaging LISINOPRIL 20 mg/1 68645-282_9e60b794-bc6a-40f2-87a1-7d4679535f4f 68645-282 HUMAN PRESCRIPTION DRUG Citalopram hydrobromide Citalopram hydrobromide TABLET ORAL 20101001 ANDA ANDA077038 Legacy Pharmaceutical Packaging CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68645-300_fd0ecaea-190b-47c2-a725-60918d85c60f 68645-300 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20120113 ANDA ANDA077095 Legacy Pharmaceutical Packaging METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68645-310_aaae8446-f6e8-4f45-9e59-69fb5585914b 68645-310 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Legacy Pharmaceutical Packaging ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68645-320_53fa7646-2047-4e70-abec-ab8c3382d8e5 68645-320 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20120207 ANDA ANDA075576 Legacy Pharmaceutical Packaging OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68645-340_042c967b-29de-440b-ae48-abd0fde417aa 68645-340 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20020917 ANDA ANDA075907 Legacy Pharmaceutical Packaging HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68645-341_1ca96cd5-8cfc-4491-8722-9c4a3f45fedc 68645-341 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 Legacy Pharmaceutical Packaging HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68645-350_b634510c-92af-4e80-b79c-0ae7356a1d51 68645-350 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Legacy Pharmaceutical Packaging CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68645-351_b634510c-92af-4e80-b79c-0ae7356a1d51 68645-351 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Legacy Pharmaceutical Packaging CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68645-400_8d86f464-7509-450a-a9ba-ae305e9a16b8 68645-400 HUMAN PRESCRIPTION DRUG Pantoprazole Pantoprazole TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA077619 Legacy Pharmaceutical Packaging PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68645-401_230961d4-5f66-4fae-a16a-8400fea96550 68645-401 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 Legacy Pharmaceutical Packaging PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68645-402_ca03c297-b4af-4ecd-9bfe-36b714ce1fb8 68645-402 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Legacy Pharmaceutical Packaging ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-403_ca03c297-b4af-4ecd-9bfe-36b714ce1fb8 68645-403 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Legacy Pharmaceutical Packaging ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-404_3ed4d464-6a78-406f-9338-823e4972d8b0 68645-404 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120330 ANDA ANDA077159 Legacy Pharmaceutical Packaging IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68645-405_63e83822-798e-46e0-87bf-45e9d2910184 68645-405 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20120330 ANDA ANDA077369 Legacy Pharmaceutical Packaging HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68645-406_12e84698-a323-4f68-8c25-7c4ac86f9798 68645-406 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA078232 Legacy Pharmaceutical Packaging LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68645-407_1faed63f-410c-4c55-8d40-25597d8f5d7e 68645-407 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Legacy Pharmaceutical Packaging LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68645-408_12e84698-a323-4f68-8c25-7c4ac86f9798 68645-408 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20110221 ANDA ANDA078232 Legacy Pharmaceutical Packaging LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68645-409_1faed63f-410c-4c55-8d40-25597d8f5d7e 68645-409 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Legacy Pharmaceutical Packaging LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68645-410_12e84698-a323-4f68-8c25-7c4ac86f9798 68645-410 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA078232 Legacy Pharmaceutical Packaging LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68645-411_1faed63f-410c-4c55-8d40-25597d8f5d7e 68645-411 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Legacy Pharmaceutical Packaging LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68645-412_01088a07-95bb-4600-ae27-ef7297e0d136 68645-412 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA090150 Legacy Pharmaceutical Packaging HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68645-417_09d95da4-4a68-4281-a362-42ac6d80a5b4 68645-417 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Legacy Pharmaceutical Packaging ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-418_09d95da4-4a68-4281-a362-42ac6d80a5b4 68645-418 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Legacy Pharmaceutical Packaging ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-430_1191b0c2-049d-4401-8a63-e92d8ef3908c 68645-430 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA076999 Legacy Pharmaceutical Packaging CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 68645-443_3b633199-420d-4e25-b835-81be160fea3f 68645-443 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120517 20160131 ANDA ANDA076999 Legacy Pharmaceutical Packaging CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 68645-444_4968c5f2-c875-4a9e-adba-a09050d9d4f9 68645-444 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Legacy Pharmaceutical Packaging AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68645-445_4968c5f2-c875-4a9e-adba-a09050d9d4f9 68645-445 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Legacy Pharmaceutical Packaging AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68645-446_b197b528-d488-40a6-a4ec-2e89fabefcaf 68645-446 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20100801 ANDA ANDA090061 Legacy Pharmaceutical Packaging FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 68645-447_7a0cc776-591a-4b21-a938-5f2cc88800e1 68645-447 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET ORAL 20120911 ANDA ANDA078604 Legacy Pharmaceutical Packaging ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68645-448_7a0cc776-591a-4b21-a938-5f2cc88800e1 68645-448 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET ORAL 20120911 ANDA ANDA078604 Legacy Pharmaceutical Packaging ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68645-449_a1f34153-7b0e-4310-90d0-b9c3253bf5bb 68645-449 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120402 ANDA ANDA090478 Legacy Pharmaceutical Packaging CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68645-450_a1f34153-7b0e-4310-90d0-b9c3253bf5bb 68645-450 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120402 ANDA ANDA090478 Legacy Pharmaceutical Packaging CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68645-451_c96d3261-b6d6-4161-bf77-27421c382297 68645-451 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071258 Legacy Pharmaceutical Packaging TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 68645-452_c96d3261-b6d6-4161-bf77-27421c382297 68645-452 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071196 Legacy Pharmaceutical Packaging TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 68645-454_9ef048ae-5594-47c1-80c6-d8411a1a0720 68645-454 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Legacy Pharmaceutical Packaging ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68645-455_9ef048ae-5594-47c1-80c6-d8411a1a0720 68645-455 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Legacy Pharmaceutical Packaging ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68645-456_9ef048ae-5594-47c1-80c6-d8411a1a0720 68645-456 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Legacy Pharmaceutical Packaging ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68645-457_9ef048ae-5594-47c1-80c6-d8411a1a0720 68645-457 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Legacy Pharmaceutical Packaging ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68645-458_72a3cde7-f07c-44f9-a4f9-5bf8545c4c08 68645-458 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130101 NDA AUTHORIZED GENERIC NDA020702 Legacy Pharmaceutical Packaging ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-459_72a3cde7-f07c-44f9-a4f9-5bf8545c4c08 68645-459 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Legacy Pharmaceutical Packaging ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-460_72a3cde7-f07c-44f9-a4f9-5bf8545c4c08 68645-460 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Legacy Pharmaceutical Packaging ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-461_72a3cde7-f07c-44f9-a4f9-5bf8545c4c08 68645-461 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Legacy Pharmaceutical Packaging ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-463_58b05c47-25f8-44fa-b593-55e61ad64db2 68645-463 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Legacy Pharmaceutical Packaging DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68645-464_58b05c47-25f8-44fa-b593-55e61ad64db2 68645-464 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Legacy Pharmaceutical Packaging DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68645-465_58b05c47-25f8-44fa-b593-55e61ad64db2 68645-465 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Legacy Pharmaceutical Packaging DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68645-466_1ba45367-4dbd-4c1c-ac34-0fe069244931 68645-466 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, COATED ORAL 20120806 ANDA ANDA201582 Legacy Pharmaceutical Packaging MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 68645-467_dba6f07c-b581-4613-826a-df7565349067 68645-467 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 Legacy Pharmaceutical Packaging CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68645-468_1632c321-ba2f-42f9-9891-395f5f5e34d3 68645-468 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Legacy Pharmaceutical Packaging CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68645-469_74ab6f64-d0a0-4f31-9d42-c813a6a62478 68645-469 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Legacy Pharmaceutical Packaging LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68645-470_1f16c291-f4b9-46a4-b3cb-97ccca06179b 68645-470 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20070601 ANDA ANDA078103 Legacy Pharmaceutical Packaging SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-471_1f16c291-f4b9-46a4-b3cb-97ccca06179b 68645-471 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20070601 ANDA ANDA078103 Legacy Pharmaceutical Packaging SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-472_1f16c291-f4b9-46a4-b3cb-97ccca06179b 68645-472 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20070601 ANDA ANDA078103 Legacy Pharmaceutical Packaging SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-473_e7189acb-e06b-4c4a-b784-edc67c329fd9 68645-473 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Legacy Pharmaceutical Packaging OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68645-474_bc557f7b-908c-4e34-8722-3e48ba7a0c70 68645-474 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110228 ANDA ANDA090796 Legacy Pharmaceutical Packaging IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68645-475_bc557f7b-908c-4e34-8722-3e48ba7a0c70 68645-475 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110228 ANDA ANDA090796 Legacy Pharmaceutical Packaging IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68645-476_bc557f7b-908c-4e34-8722-3e48ba7a0c70 68645-476 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110228 ANDA ANDA090796 Legacy Pharmaceutical Packaging IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68645-477_3605699b-4b47-4324-a325-45c0e2ca38bb 68645-477 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Legacy Pharmaceutical Packaging METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68645-478_3605699b-4b47-4324-a325-45c0e2ca38bb 68645-478 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Legacy Pharmaceutical Packaging METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68645-479_64c2815a-ae64-4535-a8b4-6b4d06efb47a 68645-479 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA078889 Legacy Pharmaceutical Packaging METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68645-480_53c6ec96-f7fa-4166-ab6f-5527b1f08c12 68645-480 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Legacy Pharmaceutical Packaging ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-481_53c6ec96-f7fa-4166-ab6f-5527b1f08c12 68645-481 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Legacy Pharmaceutical Packaging ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-482_e9051a0f-dfc1-45cc-a35a-539990a7fca8 68645-482 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Legacy Pharmaceutical Packaging ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-483_e9051a0f-dfc1-45cc-a35a-539990a7fca8 68645-483 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Legacy Pharmaceutical Packaging ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68645-484_6f1d5e12-4869-4cd1-ae7b-09d863684d4d 68645-484 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA201294 Legacy Pharmaceutical Packaging MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 68645-485_fdcd1464-69f7-4754-ba8b-c9144ca5ee01 68645-485 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20140402 ANDA ANDA202942 Legacy Pharmaceutical Packaging PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 68645-486_eef83d1e-23b7-4a9d-a4e0-a8668c9b386b 68645-486 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090790 Legacy Pharmaceutical Packaging LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68645-487_7064e50e-14a8-498e-9734-cc0db7c26367 68645-487 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Legacy Pharmaceutical Packaging SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68645-488_7064e50e-14a8-498e-9734-cc0db7c26367 68645-488 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Legacy Pharmaceutical Packaging SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68645-489_7064e50e-14a8-498e-9734-cc0db7c26367 68645-489 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Legacy Pharmaceutical Packaging SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68645-490_64f50c17-8c46-435a-8ace-cdac2adca9d4 68645-490 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 Legacy Pharmaceutical Packaging PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68645-491_d5766ce3-1a70-4c44-ac3a-0717c3e6b859 68645-491 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 Legacy Pharmaceutical Packaging PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68645-492_28c70c7f-459b-49a8-bec8-d6ec65c6e561 68645-492 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 Legacy Pharmaceutical Packaging PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68645-493_47077d04-4bf5-4634-8a73-1f55c9cf6bb2 68645-493 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 Legacy Pharmaceutical Packaging ATENOLOL 50 mg/mg Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68645-494_5056af36-234f-4a59-a6d3-690f75be3045 68645-494 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Legacy Pharmaceutical Packaging LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68647-102_36a1fca4-9c57-4cb8-b83a-ebf7f92deee1 68647-102 HUMAN OTC DRUG K-OK Kiddie Calmer Silicea , Aconite , Sucrose TABLET ORAL 20100715 UNAPPROVED HOMEOPATHIC Feelgood Health ACONITUM NAPELLUS; SILICON DIOXIDE 6; 6 [hp_C]/1; [hp_C]/1 68647-103_80e4e2bc-6b1f-41c8-a1cc-a7a141c732d8 68647-103 HUMAN OTC DRUG iBaba Chamomilla , Mag phos, Sucrose GRANULE ORAL 20100802 UNAPPROVED HOMEOPATHIC Feelgood Health MAGNESIUM PHOSPHATE; MATRICARIA RECUTITA 6; 6 [hp_C]/100mg; [hp_C]/100mg 68647-106_e024f096-2285-44bc-a0ba-fcc36297f7c3 68647-106 HUMAN OTC DRUG CroupEx Sprinkles Aconitum nap , Hepar sulph calc , Kali mur , Mag phos , Rumex crisp , Sucrose GRANULE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ACONITUM NAPELLUS; CALCIUM SULFIDE; MAGNESIUM PHOSPHATE; POTASSIUM CHLORIDE; RUMEX CRISPUS POLLEN 30; 6; 6; 6; 6 [hp_C]/40mg; [hp_C]/40mg; [hp_X]/40mg; [hp_X]/40mg; [hp_C]/40mg 68647-112_6ed4bff3-77bd-4ea3-8003-9fe83c405e56 68647-112 HUMAN OTC DRUG Hang-Over Morning Mend Humulus , Lobelia inf , Nux vom , Lactose TABLET ORAL 20100715 UNAPPROVED HOMEOPATHIC Feelgood Health HOPS; LOBELIA; STRYCHNOS NUX-VOMICA SEED 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 68647-115_1b7ceedb-3942-4940-b097-b28b2915d785 68647-115 HUMAN OTC DRUG BladderWell Sarsaparilla, Ferrum phos, Apis mel, Equisetum arv, Cantharis TABLET ORAL 20100713 UNAPPROVED HOMEOPATHIC Feelgood Health APIS MELLIFERA; EQUISETUM ARVENSE TOP; FERRUM PHOSPHORICUM; LYTTA VESICATORIA; SARSAPARILLA ROOT 30; 30; 6; 30; 30 [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1 68647-117_679a30f8-f46b-4362-9984-b9102f26a36f 68647-117 HUMAN OTC DRUG FluGo Ferrum phos, Nat mur, Belladonna, Alium cepa, Arsenicum iod TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ARSENIC TRIIODIDE; ATROPA BELLADONNA ROOT; FERRUM PHOSPHORICUM; ONION; SODIUM CHLORIDE 30; 30; 6; 30; 6 [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1 68647-118_d54fc24a-a270-4997-9df2-e737bc85461b 68647-118 HUMAN OTC DRUG RosaRex Carbo veg, Calc phos , Kali brom, Calc sil Violo tric , Lactose . TABLET ORAL 20100719 UNAPPROVED HOMEOPATHIC Feelgood Health ACTIVATED CHARCOAL; CALCIUM SILICATE; POTASSIUM BROMIDE; TRIBASIC CALCIUM PHOSPHATE; VIOLA TRICOLOR 30; 30; 30; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_C]/1 68647-120_ff68c632-e24e-4898-a801-8ccd440aede7 68647-120 HUMAN OTC DRUG BaniFlu Influenzinum , Bacillinum , Gelsemium , Lactose TABLET ORAL 20100719 UNAPPROVED HOMEOPATHIC Feelgood Health ESCHERICHIA COLI; GELSEMIUM SEMPERVIRENS ROOT; HAEMOPHILUS INFLUENZAE TYPE B 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 68647-122_8f39f7f4-8382-4be3-9f89-1d36e73c1354 68647-122 HUMAN OTC DRUG Easy Air Travel ACONITUM, ARG NIT, ARSENICUM ALB TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ACONITUM NAPELLUS; ARSENIC TRIOXIDE; SILVER NITRATE 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 68647-130_e16922bf-6b2b-4ba5-a301-f42c84e998b4 68647-130 HUMAN OTC DRUG Triple Complex Nerve Tonic Ferrum phos , Kali phos, Mag phos TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health FERRUM PHOSPHORICUM; MAGNESIUM PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 68647-131_4a39a724-8a68-4fb8-99cc-3eebd8e0760c 68647-131 HUMAN OTC DRUG Triple Complex Digestion Tonic Kali phos, Nat phos , Calc phos, Lactose TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, DIBASIC ANHYDROUS; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 68647-134_9854269d-ac34-4bce-83eb-5953c5f646c2 68647-134 HUMAN OTC DRUG Triple Complex Diabetonic Kali sulph , Nat sulphuricum , Calc phos , Lactose TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health POTASSIUM SULFATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 68647-160_de2842ca-f315-463d-b5f1-b634abea58e7 68647-160 HUMAN OTC DRUG CanTravel Mentha pip, Zingiber, Pulsatilla , Cocculus , Kali phos , Sucrose GRANULE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ANAMIRTA COCCULUS SEED; CARDAMOM; PEPPERMINT; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA PATENS 6; 3; 3; 6; 6 [hp_C]/50mg; [hp_X]/50mg; [hp_X]/50mg; [hp_C]/50mg; [hp_C]/50mg 68647-161_8c783a96-f56f-4ab4-835d-bbcba42395aa 68647-161 HUMAN OTC DRUG Eddy Ear Sprinkles Echinacea purp, Chamomilla , Calc sulph , Ferrum phos, Pulsatilla , Belladonna GRANULE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ATROPA BELLADONNA; CALCIUM SULFATE ANHYDROUS; CHAMOMILE; ECHINACEA PURPUREA; FERRUM PHOSPHORICUM; PULSATILLA VULGARIS 30; 6; 3; 3; 6; 12 [hp_C]/33.3mg; [hp_X]/33.3mg; [hp_X]/33.3mg; [hp_X]/33.3mg; [hp_X]/33.3mg; [hp_C]/33.3mg 68647-163_3231db0b-cd48-43e0-b8bf-058d788b6c7e 68647-163 HUMAN OTC DRUG KiddieVom Zingiber, Cocculus, Chamomilla , Arsenicum alb , Ipecac , Sucrose GRANULE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ARSENIC TRIOXIDE; ASCLEPIAS CURASSAVICA; CARDAMOM; CHAMOMILE; JATEORHIZA CALUMBA ROOT 6; 6; 3; 30; 3 [hp_C]/40mg; [hp_C]/40mg; [hp_X]/40mg; [hp_C]/40mg; [hp_C]/40mg 68647-165_4d3ab8fa-4961-4dd0-8361-e7c92e3bb5f6 68647-165 HUMAN OTC DRUG Oral Soothe Passiflora, Chamomilla, Calc fluor, Calc phos, Chamomilla GRANULE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ANHYDROUS DIBASIC CALCIUM PHOSPHATE; CALCIUM FLUORIDE; MATRICARIA RECUTITA; MATRICARIA RECUTITA; PASSIFLORA INCARNATA TOP 6; 6; 3; 6; 3 [hp_X]/40mg; [hp_X]/40mg; [hp_C]/40mg; [hp_X]/40mg; [hp_X]/40mg 68647-166_381e7a4c-732a-4da8-bce0-e2e5b545d376 68647-166 HUMAN OTC DRUG Acid Free-Flux Calc phos, Carbo veg, Nat phos , Mag carb, Silicea TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ACTIVATED CHARCOAL; MAGNESIUM CARBONATE; SILICON DIOXIDE; SODIUM PHOSPHATE, DIBASIC ANHYDROUS; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6; 6; 6 [hp_C]/33.3mL; [hp_C]/33.3mL; [hp_X]/33.3mL; [hp_X]/33.3mL; [hp_X]/33.3mL 68647-167_4e004023-51f7-460d-b121-6f5dc0281abf 68647-167 HUMAN OTC DRUG HayFever Fighter Arsen iod , Euphrasia , Allium cepa , Wyethia , Kali bich , Sambucus TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health AMERICAN ELDERBERRY; ARSENIC TRIIODIDE; EUPHRASIA STRICTA; ONION; POTASSIUM DICHROMATE; WYETHIA HELENIOIDES ROOT 6; 6; 6; 6; 6; 6 [hp_C]/33.3mL; [hp_C]/33.3mL; [hp_C]/33.3mL; [hp_C]/33.3mL; [hp_C]/33.3mL; [hp_C]/33.3mL 68647-168_160ecf24-1f35-4a71-a5ad-8d3c4b0cb880 68647-168 HUMAN OTC DRUG Gout-Gone Antimonium crud , Quercus , Rhododendron, Benzoic ac , Silicea , Nux vom , Ledum , Citricidal Extract TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health 2-ETHYLHEXYL 4-PHENYLBENZOPHENONE-2'-CARBOXYLATE; ANTIMONY TRISULFIDE; CANDIDA PARAPSILOSIS; LEDUM PALUSTRE TWIG; LEDUM PALUSTRE TWIG; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED 6; 6; 12; 6; 6; 6; 6 [hp_C]/28.5mL; [hp_C]/28.5mL; [hp_C]/28.5mL; [hp_C]/28.5mL; [hp_C]/28.5mL; [hp_X]/28.5mL; [hp_C]/28.5mL 68647-169_e113e22d-085d-4cf2-a835-b71a12a3aeca 68647-169 HUMAN OTC DRUG Anal Itch Ease Fagopyrum, Croton , Aesculus, Sulphur , Kali sulph , Cina TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health AESCULUS CARNEA FLOWER; ARTEMISIA CINA FLOWER; BUCKWHEAT; CASTOR OIL; POTASSIUM SULFATE; SULFUR 12; 6; 12; 6; 6; 12 [hp_C]/33.3mL; [hp_C]/33.3mL; [hp_C]/33.3mL; [hp_C]/33.3mL; [hp_X]/33.3mL; [hp_C]/33.3mL 68647-170_a76d953e-092b-47f0-acff-e12537fe34ca 68647-170 HUMAN OTC DRUG Leg Cramp Away Calc phos, Mag phos, Rhus tox , Nux vom , Citricidal extract TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE 6; 12; 6; 6 [hp_X]/50mL; [hp_C]/50mL; [hp_C]/50mL; [hp_X]/50mL 68647-171_effedad7-579e-45c7-9e6c-66c42d9bd2bb 68647-171 HUMAN OTC DRUG Headache Soothe China , Nux vom, Chamomilla, Kali phos , Mag phos TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health AILANTHUS ALTISSIMA FLOWERING TWIG; CHAMOMILE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED 12; 12; 6; 6; 12 [hp_C]/40mL; [hp_C]/40mL; [hp_X]/40mL; [hp_X]/40mL; [hp_C]/40mL 68647-172_eafeb411-a014-4dd0-98cd-866626884e53 68647-172 HUMAN OTC DRUG ORAL ASSIST ORAL ASSIST TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health BELLADONNA LEAF; CALCIUM SULFIDE; FERRUM PHOSPHORICUM; MERCURIUS SOLUBILIS; SALICYLIC ACID; SILICON DIOXIDE 30; 12; 6; 12; 6; 6 [hp_C]/33.33mg; [hp_C]/33.33mg; [hp_X]/33.33mg; [hp_C]/33.33mg; [hp_C]/33.33mg; [hp_X]/33.33mg 68647-173_27e95fa0-5ddb-4f31-ad34-4125256dfd0b 68647-173 HUMAN OTC DRUG Conjunct-a-Clear Euphrasia , Pulsatilla , Psorinum , Merc sol , Graphites, Citricidal Extract TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health EUPHRASIA STRICTA; GRAPHITE; MERCURIUS SOLUBILIS; PULSATILLA PATENS; SCABIES LESION LYSATE (HUMAN) 6; 6; 6; 12; 12 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL 68647-174_d7bd3d3e-1aa2-4ef5-a6e0-8c151e401220 68647-174 HUMAN OTC DRUG Conjunct-a-Clear Wash Euphrasia , Calendula, Agrimony, Arg nit TINCTURE OPHTHALMIC 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health AGRIMONIA EUPATORIA; CALENDULA OFFICINALIS FLOWER; EUPHRASIA STRICTA; SILVER NITRATE 3; 3; 6; 5 [hp_X]/50mL; [hp_X]/50mL; [hp_C]/50mL; [hp_X]/50mL 68647-175_952d9161-6d01-4e65-a1c8-13f08501faf8 68647-175 HUMAN OTC DRUG Tic Tamer TicTam TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ARTEMISIA CINA FLOWER; CHAMOMILE; HYOSCYAMUS; ZINC METHIONINE SULFATE 30; 12; 30; 30 [hp_C]/50mg; [hp_C]/50mg; [hp_C]/50mg; [hp_C]/50mg 68647-176_892023f3-579b-46ab-82fd-7254aa842084 68647-176 HUMAN OTC DRUG Vagi Soothe Kreosotum, Merc sol, Lycopodium , Calc carb, Sepia TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ACANTHOSEPION CUTTLEFISH; CALCIUM CARBONATE; LARREA TRIDENTATA TOP; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS 6; 6; 12; 12; 30 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL 68647-177_24c97740-6018-41fe-b1b9-5e2c949dbfe7 68647-177 HUMAN OTC DRUG Scab Ease Itch Relief Psorinum , Staphisagria , Viola tri TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health DELPHINIUM STAPHISAGRIA SEED; SCABIES LESION LYSATE (HUMAN); VIOLA TRICOLOR 12; 12; 12 [hp_C]/66.6mL; [hp_C]/66.6mL; [hp_C]/66.6mL 68647-178_2102cd03-fdba-4eb3-9dcc-b65ff595c0e1 68647-178 HUMAN OTC DRUG AngerSoothe AngerSoothe TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; MINT; STRYCHNOS NUX-VOMICA SEED 5; 6; 1; 6 [hp_C]/50mg; [hp_C]/50mg; [hp_X]/10mg; [hp_C]/50mg 68647-179_53e902b8-d0a3-4f78-908b-a0b4707d8575 68647-179 HUMAN OTC DRUG SAD Soother Calc carb, Alumina , Aurum met, Nat mur , Kali phos TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ALUMINUM OXIDE; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE 30; 30; 6; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_X]/40mL; [hp_X]/40mL 68647-180_3cd890ab-63fe-4518-858a-972c9e8fbf68 68647-180 HUMAN OTC DRUG Mucus Clear Kali mur , Kali sulph , Kali bich , Citricidal Extract TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; POTASSIUM SULFATE 6; 6; 6 [hp_X]/50mL; [hp_C]/50mL; [hp_X]/50mL 68647-181_475cf82e-8ada-4bce-bd69-a7b45fe5f8ea 68647-181 HUMAN OTC DRUG Sweat-Less Nat mur , Lupulus, Castoreum , Argentum nit , Syphilinum TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health BOWFIN; CALIFORNIA SHEEPHEAD; HOPS; SILVER NITRATE; SODIUM CHLORIDE 30; 30; 30; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_X]/40mL 68647-182_4558f8f1-501a-4058-b09e-97edd77a4fd0 68647-182 HUMAN OTC DRUG Inflammago Arnica , Dulcamara, Bryonia , Berberis , Rhus tox TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ARNICA ANGUSTIFOLIA FLOWER; BERBERIS VULGARIS FRUIT; BRYONIA ALBA ROOT; SOLANUM DULCAMARA FLOWER; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 30 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL 68647-192_811fee6a-17fa-484a-b4c9-0c5f96bf3560 68647-192 HUMAN OTC DRUG Nutra RX Arnica Pain and Healing Bellis, Symphytum, Arnica , Mag phos, Chamomilla TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ARNICA MONTANA; BELLIS PERENNIS; COMFREY ROOT; MAGNESIUM PHOSPHATE; MATRICARIA RECUTITA 6; 3; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 68647-193_7489efee-9123-4411-a252-99edf07f8ebd 68647-193 HUMAN OTC DRUG NutraRX Inflam Dr. Arnica, Dulcamara , Bryonia , Berberis , Rhus tox TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; SOLANUM DULCAMARA TOP; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 30 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL 68647-194_82f591bb-ef54-456f-bfcf-cec88942b079 68647-194 HUMAN OTC DRUG NutraRX Digest-Able Kali phos, Nat phos, Calc phos TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, DIBASIC ANHYDROUS; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 68647-195_434f6be2-60d1-4a6f-bd8d-4e200546f70f 68647-195 HUMAN OTC DRUG StyeGone Pulsatilla , Staphagria , Psorinum , Graphites TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health DELPHINIUM STAPHISAGRIA SEED; GRAPHITE; PULSATILLA PATENS; SCABIES LESION LYSATE (HUMAN) 6; 6; 6; 6 [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL 68647-196_e8601657-633a-4e7e-9e82-2e6c347c2443 68647-196 HUMAN OTC DRUG QueaseX Anti Nausea Drops Nux vom, Pulsatilla , Ipecac, Chamomilla, Zingiber TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health CARDAMOM; CHAMOMILE; IPECAC; PULSATILLA PATENS; STRYCHNOS NUX-VOMICA SEED 6; 12; 6; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL 68647-197_62305208-119e-4a40-a465-be6eadfe1181 68647-197 HUMAN OTC DRUG FibroFree Complex Bryonia, Calcarea carb, Ranunculus bulb, Rhus tox, Staphagria TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health BRYONIA ALBA ROOT; DELPHINIUM STAPHISAGRIA SEED; OYSTER SHELL CALCIUM CARBONATE, CRUDE; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL 68647-198_ff615db3-bb22-481b-ab85-1681e9f25b99 68647-198 HUMAN OTC DRUG Digesto-K Melissa , Mentha pip, Mag phos , Nat sulphuricum, Phos GRANULE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health LEMON BALM OIL; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PEPPERMINT; PHOSPHORUS; SODIUM SULFATE 3; 6; 3; 6; 6 [hp_X]/40mg; [hp_X]/40mg; [hp_X]/40mg; [hp_C]/40mg; [hp_X]/40mg 68647-200_04a0573b-8da5-4a17-9f29-ec5dff8ef299 68647-200 HUMAN OTC DRUG StretchEasy Formula Calc fluor , Calc phos, Nat mur TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ANHYDROUS DIBASIC CALCIUM PHOSPHATE; CALCIUM FLUORIDE; SODIUM CHLORIDE 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 68647-201_7893454f-f5f6-4e32-85fd-1a286f64b342 68647-201 HUMAN OTC DRUG Vagi-Clear Sepia, Kreosotum, Kali phos , Pulsatilla, Nitricum ac TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health LARREA TRIDENTATA TOP; NITRIC ACID; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA PATENS; SEPIA OFFICINALIS JUICE 6; 6; 6; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_X]/40mL; [hp_C]/40mL; [hp_C]/40mL 68647-202_38b0b2d2-5bf0-43ad-a099-5ff39c845b86 68647-202 HUMAN OTC DRUG Stomach Flu Fighter Arsenicum alb, Colocynthis , Pulsatilla , Mag phos TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ARSENIC TRIOXIDE; CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE; PULSATILLA PATENS 6; 6; 6; 6 [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL 68647-203_9323eddd-34ab-453c-abb6-ab17cbb148aa 68647-203 HUMAN OTC DRUG Boil-Rx Hepar sulph, Silica mar, Sulfur iod, Echinacea , Calc sil, Citricidal Extract TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health CALCIUM SILICATE; CALCIUM SULFIDE; ECHINACEA; SILICON DIOXIDE; SULFUR IODIDE 6; 6; 6; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_X]/40mL; [hp_C]/40mL 68647-204_392b2086-fe0d-43c6-a692-8281d94db32b 68647-204 HUMAN OTC DRUG Kidney Stone Clear Berberis vulg, Calc carb, Cantharis, Lycopodium, Belladonna TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ATROPA BELLADONNA; BERBERIS VULGARIS FRUIT; CALCIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA 6; 6; 6; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL 68647-205_ddea6f89-5da8-4f02-8edd-3a5944be2fed 68647-205 HUMAN OTC DRUG Hive Away Urtica ur , Apis mel, Chamomilla , Ammon carb, Rhus tox TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health AMMONIUM CARBONATE; APIS MELLIFERA; CHAMOMILE; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 6; 6; 6; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL 68647-206_e2311abe-7c79-44ee-b73e-1b4746c87a1d 68647-206 HUMAN OTC DRUG Sinus Soothe Kali bich, Pulsatilla, Hepar sulph , Thuja occ , Spigelia anth TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health CALCIUM SULFIDE; CEDAR LEAF OIL; POTASSIUM DICHROMATE; PULSATILLA PATENS; SPIGELIA 6; 12; 6; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL 68647-207_cdf25d0e-be83-4a9e-8d2b-27a585174fc6 68647-207 HUMAN OTC DRUG Triple Complex Calm Tonic Ferrum phos , Kali phos, Mag phos TABLET ORAL 20110620 UNAPPROVED HOMEOPATHIC Feelgood Health FERRUM PHOSPHORICUM; MAGNESIUM PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 68654-575_4a118beb-d5e9-4aee-9f0a-b5cdc6190c8d 68654-575 HUMAN OTC DRUG Insti-Foam Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL OTC MONOGRAPH NOT FINAL part333 Share Corporation BENZETHONIUM CHLORIDE 2 mg/mL 68654-585_2e007cec-4db3-4991-99df-9bf2df750dcb 68654-585 HUMAN OTC DRUG Foamahol ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333 Share Corporation ALCOHOL .7 mL/mL 68654-773_1a3bf123-1926-4474-aa7e-24c21fa6776c 68654-773 HUMAN OTC DRUG Handful Sanitizer ALCOHOL AEROSOL, FOAM TOPICAL 20090831 OTC MONOGRAPH NOT FINAL part333 Share Corporation ALCOHOL 620 mg/g 68654-855_9aa0d6c7-4a77-4c07-b388-a2a7346011a2 68654-855 HUMAN OTC DRUG Foamahol ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333E Share Corporation ALCOHOL .62 mL/mL 68669-135_8622403c-ba1b-42a6-a7d6-b2fa9112c02e 68669-135 HUMAN PRESCRIPTION DRUG QUIXIN levofloxacin SOLUTION OPHTHALMIC 20001001 NDA NDA021199 Vistakon Pharmaceuticals LLC LEVOFLOXACIN 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68669-145_6236a560-8bb3-4002-9208-979b8f06eaac 68669-145 HUMAN PRESCRIPTION DRUG IQUIX levofloxacin SOLUTION OPHTHALMIC 20040601 NDA NDA021571 Vistakon Pharmaceuticals LLC LEVOFLOXACIN 15 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68669-522_d3344ae3-17c8-47d4-988b-e872240bffcf 68669-522 HUMAN PRESCRIPTION DRUG Betimol timolol SOLUTION OPHTHALMIC 20001001 NDA NDA020439 Vistakon Pharmaceuticals LLC TIMOLOL 2.5 mg/mL 68669-525_d3344ae3-17c8-47d4-988b-e872240bffcf 68669-525 HUMAN PRESCRIPTION DRUG Betimol timolol SOLUTION OPHTHALMIC 20001001 NDA NDA020439 Vistakon Pharmaceuticals LLC TIMOLOL 5 mg/mL 68682-004_92a43a43-9038-4af5-b27c-763324dc841a 68682-004 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil CREAM TOPICAL 20060901 20150131 NDA NDA016831 Oceanside Pharmaceuticals FLUOROURACIL 5 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] 68682-065_28cdcef9-0623-4c5a-bd18-aa3d2a3d40f8 68682-065 HUMAN PRESCRIPTION DRUG Methoxsalen Methoxsalen CAPSULE, LIQUID FILLED ORAL 20140715 NDA AUTHORIZED GENERIC NDA019600 Oceanside Pharmaceuticals METHOXSALEN 10 mg/1 Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE],Psoralen [EPC],Psoralens [Chemical/Ingredient] 68682-101_c28cf3c3-8c13-46c6-a051-6de99db19882 68682-101 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, EXTENDED RELEASE ORAL 20140822 ANDA ANDA075028 Oceanside Pharmaceuticals PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 68682-146_5135c69d-7158-4366-8a47-fc48cad5d9b3 68682-146 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleate and Hydrochlorothiazide TABLET ORAL 19861031 NDA AUTHORIZED GENERIC NDA019221 Oceanside Pharmaceuticals ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68682-200_39049ed2-b4c2-499b-a9d6-005a906c8d99 68682-200 HUMAN PRESCRIPTION DRUG Carbidopa Carbidopa Tablets TABLET ORAL 20140404 NDA AUTHORIZED GENERIC NDA017830 Oceanside Pharmaceuticals CARBIDOPA 25 mg/1 68682-302_b37704b4-5fbf-4d15-9d3b-37d94c175862 68682-302 HUMAN PRESCRIPTION DRUG Pyridostigmine Bromide Pyridostigmine Bromide TABLET ORAL 20071030 NDA AUTHORIZED GENERIC NDA009829 Oceanside Pharmaceuticals PYRIDOSTIGMINE BROMIDE 60 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68682-357_977de209-c53a-4cb4-9f3f-1e850600a9dc 68682-357 HUMAN PRESCRIPTION DRUG Dihydroergotamine Mesylate dihydroergotamine mesylate SPRAY NASAL 20130318 NDA AUTHORIZED GENERIC NDA020148 Oceanside Pharmaceuticals DIHYDROERGOTAMINE MESYLATE 4 mg/mL Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient] 68682-367_0b5f7d30-7b5e-4fb5-9fd9-b7f248e37036 68682-367 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA AUTHORIZED GENERIC NDA020401 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68682-368_0b5f7d30-7b5e-4fb5-9fd9-b7f248e37036 68682-368 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA AUTHORIZED GENERIC NDA020401 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68682-369_0b5f7d30-7b5e-4fb5-9fd9-b7f248e37036 68682-369 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA AUTHORIZED GENERIC NDA020401 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68682-370_0b5f7d30-7b5e-4fb5-9fd9-b7f248e37036 68682-370 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA AUTHORIZED GENERIC NDA020401 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68682-371_0b5f7d30-7b5e-4fb5-9fd9-b7f248e37036 68682-371 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA AUTHORIZED GENERIC NDA020401 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68682-372_0b5f7d30-7b5e-4fb5-9fd9-b7f248e37036 68682-372 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA AUTHORIZED GENERIC NDA020401 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68682-409_3fcc6460-5173-40f5-973c-8709eeb0737e 68682-409 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride and Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20090923 NDA AUTHORIZED GENERIC NDA012750 Oceanside Pharmaceuticals CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] 68682-513_d3c528d2-429d-4f37-9ebf-eee8b9fd3050 68682-513 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20130314 NDA AUTHORIZED GENERIC NDA020475 Oceanside Pharmaceuticals TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 68682-514_d3c528d2-429d-4f37-9ebf-eee8b9fd3050 68682-514 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20130314 NDA AUTHORIZED GENERIC NDA020475 Oceanside Pharmaceuticals TRETINOIN .4 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 68682-519_39ac6363-93bc-4e12-a7a7-667eafac42a5 68682-519 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin TABLET, FILM COATED ORAL 20121203 NDA AUTHORIZED GENERIC NDA050475 Oceanside Pharmaceuticals GRISEOFULVIN 125 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 68682-520_39ac6363-93bc-4e12-a7a7-667eafac42a5 68682-520 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin TABLET, FILM COATED ORAL 20121203 NDA AUTHORIZED GENERIC NDA050475 Oceanside Pharmaceuticals GRISEOFULVIN 250 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] 68682-521_19c71336-68e8-4bd7-9fe0-8a6867b8db5e 68682-521 HUMAN PRESCRIPTION DRUG Diltiazem HCl CD Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20120718 NDA AUTHORIZED GENERIC NDA020062 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68682-525_2e172c97-8870-43c3-99f4-6912559501a5 68682-525 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20120625 20150930 ANDA ANDA090715 Oceanside Pharmaceuticals FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68682-528_2e172c97-8870-43c3-99f4-6912559501a5 68682-528 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20120625 20151031 ANDA ANDA090715 Oceanside Pharmaceuticals FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68682-638_2137f45d-4715-4ae4-a805-ccf0c480d399 68682-638 HUMAN PRESCRIPTION DRUG Tretinoin TRETINOIN CREAM TOPICAL 20110201 ANDA ANDA076498 Oceanside Pharmaceuticals TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 68682-705_73b3607a-99d0-44d8-92ef-0074684c9d7d 68682-705 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride Extended-Release Tablets TABLET, EXTENDED RELEASE ORAL 20140206 NDA AUTHORIZED GENERIC NDA021392 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68682-706_73b3607a-99d0-44d8-92ef-0074684c9d7d 68682-706 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride Extended-Release Tablets TABLET, EXTENDED RELEASE ORAL 20140206 NDA AUTHORIZED GENERIC NDA021392 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68682-707_73b3607a-99d0-44d8-92ef-0074684c9d7d 68682-707 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride Extended-Release Tablets TABLET, EXTENDED RELEASE ORAL 20140206 NDA AUTHORIZED GENERIC NDA021392 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68682-708_73b3607a-99d0-44d8-92ef-0074684c9d7d 68682-708 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride Extended-Release Tablets TABLET, EXTENDED RELEASE ORAL 20140206 NDA AUTHORIZED GENERIC NDA021392 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68682-709_73b3607a-99d0-44d8-92ef-0074684c9d7d 68682-709 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride Extended-Release Tablets TABLET, EXTENDED RELEASE ORAL 20140206 NDA AUTHORIZED GENERIC NDA021392 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68682-992_39fc0af0-ed32-4183-9984-5eb5213f5e6b 68682-992 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide CREAM TOPICAL 20140106 NDA AUTHORIZED GENERIC NDA021758 Oceanside Pharmaceuticals FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68682-993_43892b97-449d-45bc-bb09-29d47c655d65 68682-993 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 OCEANSIDE PHARMACEUTICALS DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68682-994_43892b97-449d-45bc-bb09-29d47c655d65 68682-994 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 OCEANSIDE PHARMACEUTICALS DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68682-995_7b7eb673-398f-460d-a584-25d53754fb6b 68682-995 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir OINTMENT TOPICAL 20121003 20160630 NDA AUTHORIZED GENERIC NDA018604 Oceanside Pharmaceuticals ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68682-997_43892b97-449d-45bc-bb09-29d47c655d65 68682-997 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 OCEANSIDE PHARMACEUTICALS DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68682-998_43892b97-449d-45bc-bb09-29d47c655d65 68682-998 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 OCEANSIDE PHARMACEUTICALS DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68685-0001_6ceddeb1-5ab7-4cef-a2eb-aec70b897c5f 68685-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040221 UNAPPROVED MEDICAL GAS All American Medical Equipment, Inc. OXYGEN 99 L/100L 68693-001_4937c3a8-8e93-446c-bade-b2d7c7727067 68693-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19950101 UNAPPROVED MEDICAL GAS Specialty Gases of America OXYGEN 99 L/100L 68693-003_38ab4134-fc83-45cc-9873-2839dec8eee6 68693-003 HUMAN PRESCRIPTION DRUG COMPRESSED GAS OXIDIZING,N.O.S. CARBON DIOXIDE OXYGEN MIXTURE GAS RESPIRATORY (INHALATION) 19950101 UNAPPROVED MEDICAL GAS Specialty Gases of America OXYGEN 80 L/100L 68693-004_38ab4134-fc83-45cc-9873-2839dec8eee6 68693-004 HUMAN PRESCRIPTION DRUG COMPRESSED GAS OXIDIZING,N.O.S. CARBON DIOXIDE OXYGEN MIXTURE GAS RESPIRATORY (INHALATION) 19950101 UNAPPROVED MEDICAL GAS Specialty Gases of America OXYGEN 90 L/100L 68693-005_38ab4134-fc83-45cc-9873-2839dec8eee6 68693-005 HUMAN PRESCRIPTION DRUG COMPRESSED GAS OXIDIZING,N.O.S. CARBON DIOXIDE OXYGEN MIXTURE GAS RESPIRATORY (INHALATION) 19950101 UNAPPROVED MEDICAL GAS Specialty Gases of America OXYGEN 96 L/100L 68693-006_38ab4134-fc83-45cc-9873-2839dec8eee6 68693-006 HUMAN PRESCRIPTION DRUG COMPRESSED GAS OXIDIZING,N.O.S. CARBON DIOXIDE OXYGEN MIXTURE GAS RESPIRATORY (INHALATION) 19950101 UNAPPROVED MEDICAL GAS Specialty Gases of America OXYGEN 95 L/100L 68693-010_6c197296-6a1f-4553-a7a2-eba1011c46a3 68693-010 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19950101 UNAPPROVED MEDICAL GAS Specialty Gases of America NITROUS OXIDE 99 kg/100kg 68693-011_b88625fa-12a5-49e1-beb2-5b2cfad204f3 68693-011 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19950101 UNAPPROVED MEDICAL GAS Specialty Gases of America NITROGEN 99 L/100L 68693-012_91072629-5ee3-4427-9362-64fcea5511bb 68693-012 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19950101 UNAPPROVED MEDICAL GAS Specialty Gases of America CARBON DIOXIDE 99 kg/100kg Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] 68693-018_afc2605b-60a0-494d-af0f-826d5d1e9129 68693-018 HUMAN PRESCRIPTION DRUG HELIUM HELIUM GAS RESPIRATORY (INHALATION) 19950101 UNAPPROVED MEDICAL GAS Specialty Gases of America, Inc HELIUM 99 L/100L 68693-021_02476476-9c24-4a8c-afbb-fcdf717491f8 68693-021 HUMAN PRESCRIPTION DRUG AIR COMPRESSED AIR COMPRESSED GAS RESPIRATORY (INHALATION) 19950101 UNAPPROVED MEDICAL GAS Specialty Gases of America OXYGEN 20 L/100L 68698-001_309c4ecf-9a4e-4b78-af8e-cb4bceadb631 68698-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20030101 UNAPPROVED MEDICAL GAS Oxygen Plus LLC OXYGEN 99 L/100L 68703-002_4e023ebf-ad99-4105-976e-788ef1625502 68703-002 HUMAN OTC DRUG MediAc Carbo veg , Causticum, Hepar sulph, Silicea , Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20130115 UNAPPROVED HOMEOPATHIC Native Remedies LLC ACTIVATED CHARCOAL; CALCIUM SULFIDE; CAUSTICUM; SILICON DIOXIDE 30; 30; 30; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 68703-003_48ce9c77-71b3-4ca7-8e39-a473078e19d0 68703-003 HUMAN OTC DRUG Be-Dry Equisetum arv TABLET ORAL 20130102 UNAPPROVED HOMEOPATHIC Native Remedies, LLC EQUISETUM ARVENSE TOP 6 [hp_C]/1 68703-004_1ab1357d-8220-4289-b896-2aa937edeba7 68703-004 HUMAN OTC DRUG SocialFear Relief Cacao, Gelsemium, Graphites, Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20130117 UNAPPROVED HOMEOPATHIC Native Remedies, LLC COCOA; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 68703-005_0da3b1c6-6ac8-40de-8a20-8afae1ffb740 68703-005 HUMAN OTC DRUG Skin Dr Galium, Kali mur, Kali sulph, Nat mur, Urtica ur, Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20130115 UNAPPROVED HOMEOPATHIC Native Remedies LLC GALIUM APARINE; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM CHLORIDE; URTICA URENS 3; 6; 6; 6; 6 [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 68703-006_5481ad2f-e078-4036-8014-691daf4041c9 68703-006 HUMAN OTC DRUG HaliTonic Carduus mar, Kali phos, Nat sulphuricum, Nux vom, Silicea, Acacia gum, Lactose, Magnesium stearate, Corn starch, Sucrose. TABLET ORAL 20121228 UNAPPROVED HOMEOPATHIC Native Remedies LLC POTASSIUM PHOSPHATE, DIBASIC; SILICON DIOXIDE; SILYBUM MARIANUM SEED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED 6; 6; 3; 6; 3 [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1 68703-007_797bb695-f030-42e5-b44a-4d66947aa0e0 68703-007 HUMAN OTC DRUG DeodoRite Calc sulph, Carduus mar, Galium, Mag phos, Merc solub, Silicea, Acacia gum, lactose, magnesium stearate, starch, sucrose TABLET ORAL 20130102 UNAPPROVED HOMEOPATHIC Native Remedies LLC CALCIUM SULFATE ANHYDROUS; GALIUM APARINE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS; SILICON DIOXIDE; SILYBUM MARIANUM SEED 6; 3; 8; 30; 8; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1 68703-008_bc3fe345-3a2b-479f-aaf9-1f7cec8d2d2e 68703-008 HUMAN OTC DRUG TremorSoothe Agaricus musc, Mag phos, Stramonium, Tarentula hisp TABLET ORAL 20130130 UNAPPROVED HOMEOPATHIC Native Remedies, LLC AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; DATURA STRAMONIUM; LYCOSA TARANTULA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6; 6; 6; 8 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1 68703-009_c49d071d-21cd-443c-a782-8867b0c9dc7c 68703-009 HUMAN OTC DRUG VertiFree Bryonia , Cocculus, Gelsemium, Lobelia inf, Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Native Remedies LLC ANAMIRTA COCCULUS SEED; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; LOBELIA INFLATA 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 68703-016_61adb221-415f-4b73-a739-c54f24828633 68703-016 HUMAN OTC DRUG AnemiCare Calc phos, Ferrum met, Ferrum phos TABLET ORAL 20130115 UNAPPROVED HOMEOPATHIC Native Remedies, LLC FERROSOFERRIC PHOSPHATE; IRON; TRIBASIC CALCIUM PHOSPHATE 8; 6; 8 [hp_X]/1; [hp_C]/1; [hp_X]/1 68703-017_310a00cb-fd87-4816-8ef4-2c5156a0c33e 68703-017 HUMAN OTC DRUG Bad Dream Sprinkles Aconitum nap 30C HPUS, Chamomilla 3X HPUS, Kali phos 6C HPUS, Nat sulphuricum 6C HPUS, Passiflora 3X HPUS GRANULE ORAL 20120701 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACONITUM NAPELLUS; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; SODIUM SULFATE 30; 3; 3; 6; 6 [hp_C]/40mg; [hp_X]/40mg; [hp_X]/40mg; [hp_C]/40mg; [hp_C]/40mg 68703-018_4700bc5d-8708-4e2a-a5d3-61c791b75247 68703-018 HUMAN OTC DRUG MoodCalm Hyoscyamus, Kali phos, Nat sulphuricum, Tarentula hisp, Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20120615 UNAPPROVED HOMEOPATHIC Native Remedies, LLC HYOSCYAMUS NIGER; LYCOSA TARANTULA; POTASSIUM PHOSPHATE, DIBASIC; SODIUM SULFATE 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1 68703-024_c66c997b-b4b1-4efc-978a-871483f78be1 68703-024 HUMAN OTC DRUG ProState Relief Chimaphila umb, Clematis virg, Conium, Cubeba, Sabal TABLET ORAL 20130130 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CHIMAPHILA UMBELLATA; CLEMATIS VIRGINIANA TOP; CONIUM MACULATUM FLOWERING TOP; PIPER CUBEBA FRUIT; SAW PALMETTO 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 68703-026_5130eca8-a93d-4027-9c6c-a5f9427009e3 68703-026 HUMAN OTC DRUG Sniffly Sprinkles Allium cepa, Ferrum phos, Nat mur, Nuz vom, Pulsatilla GRANULE ORAL 20130130 UNAPPROVED HOMEOPATHIC Native Remedies, LLC FERROSOFERRIC PHOSPHATE; ONION; PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 8; 6; 6; 6; 30 [hp_X]/16mg; [hp_C]/16mg; [hp_C]/16mg; [hp_X]/16mg; [hp_C]/16mg 68703-027_212ac96f-5c63-4cef-8cc0-a2e55d35d572 68703-027 HUMAN OTC DRUG Good Morning Mama Ferrum phos, Mentha pip, Nat mur, Nat phos, Nux vom, Zingiber GRANULE ORAL 20121227 UNAPPROVED HOMEOPATHIC Native Remedies, LLC FERROSOFERRIC PHOSPHATE; GINGER; MENTHA PIPERITA; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED 6; 3; 3; 6; 6; 30 [hp_X]/13.33mg; [hp_X]/13.33mg; [hp_X]/13.33mg; [hp_X]/13.33mg; [hp_X]/13.33mg; [hp_C]/13.33mg 68703-028_f484a88f-452d-44d7-82a3-cb88b0b18759 68703-028 HUMAN OTC DRUG Melancholy Lift Ignatia, Kali phos, Nat sulphuricum, Staphysagria TABLET ORAL 20120801 UNAPPROVED HOMEOPATHIC Native Remedies, LLC DELPHINIUM STAPHISAGRIA SEED; POTASSIUM PHOSPHATE, DIBASIC; SODIUM SULFATE; STRYCHNOS IGNATII SEED 6; 6; 6; 6 [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 68703-029_cb3c7fda-f6e6-4520-9a01-017a9368f99f 68703-029 HUMAN OTC DRUG Tula Tantrum Tamer Chamomilla, Cina GRANULE ORAL 20120701 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARTEMISIA CINA PRE-FLOWERING TOP; MATRICARIA RECUTITA 6; 6 [hp_C]/50mg; [hp_C]/50mg 68703-030_7f0a13d4-90a7-4d89-8fb1-f71cc9bed052 68703-030 HUMAN OTC DRUG CanTravel Cocculusm, Kali phos, Mentha pip, Pulsatilla, Zingiber GRANULE OCCLUSIVE DRESSING TECHNIQUE 20120801 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ANAMIRTA COCCULUS SEED; GINGER; MENTHA PIPERITA; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS 5; 3; 3; 6; 6 [hp_C]/40mg; [hp_X]/40mg; [hp_X]/40mg; [hp_C]/40mg; [hp_C]/40mg 68703-031_f69ab50a-f015-4074-bb0d-df999977d308 68703-031 HUMAN OTC DRUG BladderWell Apis mel, Cantharis, Equisetum arv, Ferrum phos, Sarsaparilla, Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20120629 UNAPPROVED HOMEOPATHIC Native Remedies, LLC APIS MELLIFERA; EQUISETUM ARVENSE TOP; FERROSOFERRIC PHOSPHATE; LYTTA VESICATORIA; SMILAX REGELII ROOT 30; 30; 8; 30; 30 [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1 68703-033_5939f755-e4c5-4505-b4be-3a35d2b015d9 68703-033 HUMAN OTC DRUG Birth-Heal Angelica, Arnica, Mag phos, Passiflora, Silicea TABLET ORAL 20120801 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ANGELICA SINENSIS ROOT; ARNICA MONTANA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PASSIFLORA INCARNATA FLOWERING TOP; SILICON DIOXIDE 6; 6; 8; 3; 8 [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 68703-035_e54cf84c-cbe9-4b12-b584-2066829440b7 68703-035 HUMAN OTC DRUG BaniFlu Gelsemium, Influenzinum, Nux vom TABLET ORAL 20130102 UNAPPROVED HOMEOPATHIC Native Remedies, LLC GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS A/NEW CALEDONIA/20/99 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/PANAMA/2007/99 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/HONG KONG/330/2001 ANTIGEN (PROPIOLACTONE INACTIVATED); STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 68703-036_66b26b36-b184-4aea-97a9-588f16b6550c 68703-036 HUMAN OTC DRUG AgoraFear Relief Aconitum nap, Calc carb, Nat carb TABLET OCCLUSIVE DRESSING TECHNIQUE 20120901 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACONITUM NAPELLUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CARBONATE 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 68703-037_9d071d82-8b78-4155-9140-aae04f49f1f1 68703-037 HUMAN OTC DRUG Triple Complex Brain Tonic Calc phos, Kali phos, Nat mur TINCTURE ORAL 20130304 UNAPPROVED HOMEOPATHIC Native Remedies, LLC POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; TRIBASIC CALCIUM PHOSPHATE 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68703-038_3289f39c-d2f6-4b4d-a9ef-f10495cc64eb 68703-038 HUMAN OTC DRUG Triple Complex BronchoSoothe Kali phos, Mag phos, Nat sulphuricum TINCTURE ORAL 20130320 UNAPPROVED HOMEOPATHIC Native Remedies, LLC MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM SULFATE 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68703-039_d87ba6c9-96a1-4230-913b-7257930437c9 68703-039 HUMAN OTC DRUG BrightSpark Arg nit, Arsenicum iod, Hyoscyamus, Veratrum alb TABLET ORAL 20121004 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARSENIC TRIIODIDE; HYOSCYAMUS NIGER; SILVER NITRATE; VERATRUM ALBUM ROOT 30; 30; 6; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 68703-040_6c5c5d19-9db2-4954-9b67-915dc2c16b4f 68703-040 HUMAN OTC DRUG CoughEx Sprinkles Aconitum nap, Hepar sulph calc, Kali mur, Mag phos, Rumex crisp GRANULE ORAL 20121127 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACONITUM NAPELLUS; CALCIUM SULFIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; RUMEX CRISPUS ROOT 30; 6; 8; 6; 6 [hp_C]/16mg; [hp_C]/16mg; [hp_X]/16mg; [hp_X]/16mg; [hp_C]/16mg 68703-042_5b57ed03-0fba-444b-9a42-349712bc12f5 68703-042 HUMAN OTC DRUG Triple Complex Diabetonic Calc phos, Kali sulph, Nat sulphuricum TINCTURE ORAL 20130329 UNAPPROVED HOMEOPATHIC Native Remedies, LLC POTASSIUM SULFATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68703-043_8f8a347b-b8d4-4df1-9d71-bb97da8d924a 68703-043 HUMAN OTC DRUG Triple Complex Digestion Tonic Calc phos, Kali phos, Nat Phos TINCTURE ORAL 20130403 UNAPPROVED HOMEOPATHIC Native Remedies, LLC POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TRIBASIC CALCIUM PHOSPHATE 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68703-045_b1986c97-b2f3-4433-b5cb-2a7cc0e0c260 68703-045 HUMAN OTC DRUG FluGo Allium cepa, Arsenicum iod, Belladonna, Ferrum phos, Nat mur TABLET ORAL 20120901 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARSENIC TRIIODIDE; ATROPA BELLADONNA; FERROSOFERRIC PHOSPHATE; ONION; SODIUM CHLORIDE 30; 30; 8; 30; 6 [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1 68703-047_291cf044-01d9-409f-9fcb-09cdc246f734 68703-047 HUMAN OTC DRUG iBaba Chamomilla, Mag phos GRANULE ORAL 20130107 UNAPPROVED HOMEOPATHIC Native Remedies, LLC MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA 6; 6 [hp_C]/40mg; [hp_C]/40mg 68703-049_838468cd-25e2-4df4-abc4-ddc572984215 68703-049 HUMAN OTC DRUG K-OK Kiddie Calmer Aconitinum, silicea GRANULE ORAL 20120801 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACONITUM NAPELLUS; SILICON DIOXIDE 6; 6 [hp_C]/100mg; [hp_C]/100mg 68703-051_b51045f3-ae0f-423e-99ac-389143c0ec98 68703-051 HUMAN OTC DRUG Triple Complex Mood Tonic Kali phos, Nat phos, Nat sulph TINCTURE ORAL 20130403 UNAPPROVED HOMEOPATHIC Native Remedies, LLC POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68703-052_6d49ebc2-3915-487c-ab53-09e391c8011a 68703-052 HUMAN OTC DRUG Moms Magic Trauma Sprinkles Aconitum nap, Arnica, Chamomilla, Passiflora, Scutellaria, Citric acid, corn starch, potassium sorbate, sucrose GRANULE ORAL 20130117 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACONITUM NAPELLUS; ARNICA MONTANA; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA 30; 6; 30; 3; 3 [hp_C]/16mg; [hp_C]/16mg; [hp_C]/16mg; [hp_X]/16mg; [hp_X]/16mg 68703-053_166cc43d-5c7d-4da8-9ca0-6dab8598881d 68703-053 HUMAN OTC DRUG N-Con Tonic Calc fluor, Equisetum arv, Nat phos, Nat sulphuricum, Pulsatilla, Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20130116 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CALCIUM FLUORIDE; EQUISETUM ARVENSE TOP; PULSATILLA VULGARIS; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE 6; 3; 3; 6; 6 [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1 68703-054_867b2237-4439-4cd5-a1d3-b04c0921f071 68703-054 HUMAN OTC DRUG Triple Complex Calm Tonic Ferrum phos, Kali phos, Mag phos TINCTURE ORAL 20130403 UNAPPROVED HOMEOPATHIC Native Remedies, LLC FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM PHOSPHATE, DIBASIC 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68703-055_a53d5003-fbaf-48da-a604-cf5eac543493 68703-055 HUMAN OTC DRUG Triple Complex NicoTonic Kali ohosphoricum, Natrum muriaticum, Natrum ohosphoricum TINCTURE ORAL 20130403 UNAPPROVED HOMEOPATHIC Native Remedies, LLC POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68703-056_a7ce84ba-001a-4a0f-89a6-6f2689ccacbf 68703-056 HUMAN OTC DRUG OralSoothe Calc fluor, Calc phos, Chamomilla, Chamomilla, Passiflora GRANULE ORAL 20130108 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CALCIUM FLUORIDE; MATRICARIA RECUTITA; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE 8; 3; 6; 3; 8 [hp_X]/16mg; [hp_C]/16mg; [hp_X]/16mg; [hp_X]/16mg; [hp_X]/16mg 68703-066_06f5a319-a80b-42fa-b8fc-dc3d13e0f8fb 68703-066 HUMAN OTC DRUG RealHeal Arnica, Bellis, Chamomilla, Mag phos, Symphytum, Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20130121 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARNICA MONTANA; BELLIS PERENNIS; COMFREY ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA 3; 3; 3; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 68703-067_5e066355-00fe-48be-be6e-a7ad1d148e74 68703-067 HUMAN OTC DRUG RosaRex Calc phos, Calc sil, Carbo veg, Kali brom, Viola tri TABLET ORAL 20120801 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACTIVATED CHARCOAL; CALCIUM SILICATE; POTASSIUM BROMIDE; TRIBASIC CALCIUM PHOSPHATE; VIOLA TRICOLOR 30; 30; 30; 8; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_C]/1 68703-069_34e51e9d-9076-4013-b800-33276a1a1a89 68703-069 HUMAN OTC DRUG Triple Complex Sleep Tonic Cacl phos, Calc sulph, Mag phos TINCTURE ORAL 20130404 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CALCIUM SULFATE ANHYDROUS; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TRIBASIC CALCIUM PHOSPHATE 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68703-070_29cab8e0-1c0f-4c09-99f7-f65f23e2b467 68703-070 HUMAN OTC DRUG TripleComplex Slimmers Assist Calc fluor, Calc phos, Hali phos TINCTURE ORAL 20130404 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CALCIUM FLUORIDE; POTASSIUM PHOSPHATE, DIBASIC; TRIBASIC CALCIUM PHOSPHATE 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68703-071_3af572fc-0c99-4d5f-ba43-95f2568d6892 68703-071 HUMAN OTC DRUG Throar Dr. Belladonna, Gelsemium, Hepar sulph calc, Merc sol, Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20130124 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ATROPA BELLADONNA; CALCIUM SULFIDE; GELSEMIUM SEMPERVIRENS ROOT; MERCURIUS SOLUBILIS 30; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 68703-072_d3d8098e-1ade-4f34-9025-8b1b347f6287 68703-072 HUMAN OTC DRUG Triple Complex UT Tonic Ferrum phos, Kali sulp, Nat phos TINCTURE ORAL 20130424 UNAPPROVED HOMEOPATHIC Native Remedies, LLC FERROSOFERRIC PHOSPHATE; POTASSIUM SULFATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68703-074_ca968f76-9349-4fae-9f28-ac920ea03270 68703-074 HUMAN OTC DRUG Kidney Stone Clear Belladona, Berberis vulgaris, Calc carb, Cantharis, Lycopodium TINCTURE ORAL 20130327 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; OYSTER SHELL CALCIUM CARBONATE, CRUDE 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 68703-075_511338f6-3dd0-462d-ba82-5bbe166521ec 68703-075 HUMAN OTC DRUG Scab-Ease Itch Relief Arum triph, Staphysagria, Viola tri TINCTURE ORAL 20130320 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARISAEMA TRIPHYLLUM ROOT; DELPHINIUM STAPHISAGRIA SEED; VIOLA TRICOLOR 6; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 68703-076_f1e53ef8-eefb-4f83-98e7-fd8c1d1ef9a3 68703-076 HUMAN OTC DRUG Acid Free-Flux Calc phos, Carbo veg, Mag carb, Nat phos, Silicea TINCTURE ORAL 20130424 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACTIVATED CHARCOAL; MAGNESIUM CARBONATE; SILICON DIOXIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68703-077_f445d7a3-55c0-434c-b7b2-f5e2b7a14a65 68703-077 HUMAN OTC DRUG Anal Itch Assist Aesculus, Cina, Croton, Fagopyrum, Kali sulph, Sulphur TINCTURE ORAL 20131021 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARTEMISIA CINA PRE-FLOWERING TOP; CROTON TIGLIUM SEED; FAGOPYRUM ESCULENTUM; HORSE CHESTNUT; POTASSIUM SULFATE; SULFUR 6; 6; 12; 12; 6; 12 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL 68703-078_af9ebf8c-e2bc-4fe0-a0ef-55dc3cfd4549 68703-078 HUMAN OTC DRUG Anger Soothe Chamomilla, Lycopodium, Nux vomica TINCTURE ORAL 20130404 UNAPPROVED HOMEOPATHIC Native Remedies, LLC LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; STRYCHNOS NUX-VOMICA SEED 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 68703-079_3223487b-1cac-4880-8048-028439aced0b 68703-079 HUMAN OTC DRUG Boil-Rx Calc sil, Echinacea, Hepar sulph, Silica mar, Sulfur iod TINCTURE ORAL 20130424 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CALCIUM SILICATE; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; SILICON DIOXIDE; SULFUR IODIDE 6; 6; 6; 8; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 68703-080_34cf01a7-038d-4211-a0a4-ef452e54efc5 68703-080 HUMAN OTC DRUG Conjunct-a-Clear Euphrasia, Graphites, Mer sol, Pulsatilla, Psorinum TINCTURE ORAL 20130424 UNAPPROVED HOMEOPATHIC Native Remedies, LLC EUPHRASIA STRICTA; GRAPHITE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SCABIES LESION LYSATE (HUMAN) 6; 6; 6; 12; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 68703-081_c9b87567-00b5-41bd-96dd-3180b46aed1f 68703-081 HUMAN OTC DRUG Conjunct-a-Clear Wash Agrimony, Arg nit, Calendula, Euphrasia TINCTURE ORAL 20130424 UNAPPROVED HOMEOPATHIC Native Remedies, LLC AGRIMONIA EUPATORIA; CALENDULA OFFICINALIS FLOWERING TOP; EUPHRASIA STRICTA; SILVER NITRATE 8; 3; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL 68703-082_e7738006-b17e-4bda-ba39-e0b61482251a 68703-082 HUMAN OTC DRUG FibroFree Complex Bryonia, Calc carb, Ranunc bulb, Rhus tox, Staphysag TINCTURE ORAL 20130425 UNAPPROVED HOMEOPATHIC Native Remedies, LLC BRYONIA ALBA ROOT; DELPHINIUM STAPHISAGRIA SEED; OYSTER SHELL CALCIUM CARBONATE, CRUDE; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 68703-083_a915c04b-7c1c-4ebe-bf9e-519e0182a458 68703-083 HUMAN OTC DRUG Gout Gone Antimoium crud, Benzoic ac, Ledum, Nux vom, Quercus, Rhododendron, Silicea TINCTURE ORAL 20130415 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ANTIMONY TRISULFIDE; BENZOIC ACID; LEDUM PALUSTRE TWIG; QUERCUS ROBUR NUT; RHODODENDRON AUREUM LEAF; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED 6; 6; 6; 12; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 68703-084_4c831aa9-ba38-4c0a-9890-3bd61f07614b 68703-084 HUMAN OTC DRUG HayFever Fighter Allium cepa, Arsen iod, Euphrasia, Kali bich, Sambucus, Wyethia TINCTURE ORAL 20130411 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARSENIC TRIIODIDE; EUPHRASIA STRICTA; ONION; POTASSIUM DICHROMATE; SAMBUCUS CANADENSIS FLOWER; WYETHIA HELENIOIDES ROOT 6; 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 68703-085_cf06c8c2-da4d-4f5d-be57-a1b4acecc4ac 68703-085 HUMAN OTC DRUG Headache Soothe Chamomilla, Cinchona, Kali phos, Mag phos, Nux vom TINCTURE ORAL 20130411 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CINCHONA OFFICINALIS BARK; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED 12; 12; 12; 6; 12 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 68703-086_0a20e1b2-eed6-408d-b258-56d568d782a5 68703-086 HUMAN OTC DRUG Hive Away Ammonium carbonicum, Apis mellifica, Chamomilla, Rhus toxicodendron, Urtica urens TINCTURE ORAL 20130411 UNAPPROVED HOMEOPATHIC Native Remedies, LLC AMMONIUM CARBONATE; APIS MELLIFERA; MATRICARIA RECUTITA; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 68703-087_2a672b49-3204-4ce5-8798-8574aae40a9f 68703-087 HUMAN OTC DRUG Inflammago Arnica, Dulcamara, Berberis, Bryonia, Rhus tox TINCTURE ORAL 20130410 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; SOLANUM DULCAMARA TOP; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 68703-088_630b52cc-a15f-4ebb-8bbc-022c2f22b154 68703-088 HUMAN OTC DRUG Leg Cramp Away Calc phos, Mag phos, Nux vom, Rhus tox TINCTURE ORAL 20130410 UNAPPROVED HOMEOPATHIC Native Remedies, LLC MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE 6; 12; 6; 6 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 68703-089_cd9d4d3a-89db-44e3-b67a-508ae6dad583 68703-089 HUMAN OTC DRUG Mucus-Clear Kali muriaticum, Kali sulphuricum, Kali bichromicum TINCTURE ORAL 20130325 UNAPPROVED HOMEOPATHIC Native Remedies, LLC POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; POTASSIUM SULFATE 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 68703-090_080b1975-6256-4e2f-9aed-656dcd384eeb 68703-090 HUMAN OTC DRUG Oral Assist Belladonna 30C HPUS, Ferrum phosphoricum 12 X HPUS, Hepar sulphuris 12C HPUS, Mercurius solubilis 12C HPUS, Salicylicum acidum 6C HPUS, Silicea 6X HPUS TINCTURE ORAL 20130409 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ATROPA BELLADONNA; CALCIUM SULFIDE; FERROSOFERRIC PHOSPHATE; MERCURIUS SOLUBILIS; SALICYLIC ACID; SILICON DIOXIDE 30; 12; 12; 12; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL 68703-091_e0d5f30c-33a3-468f-bb5b-07dc73bb2bde 68703-091 HUMAN OTC DRUG QueaseX Anti Nausea Drops Cahmomilla, Ipecac, Nux vom, Pulsatilla, Zingiber TINCTURE ORAL 20130409 UNAPPROVED HOMEOPATHIC Native Remedies, LLC GINGER; IPECAC; MATRICARIA RECUTITA; PULSATILLA VULGARIS; STRYCHNOS NUX-VOMICA SEED 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 68703-092_10a18e2a-2e17-4627-8118-6bb2d3335dc3 68703-092 HUMAN OTC DRUG SAD Soother Alumina, Aurum met, Calc carb, Kali phos, Nar mur TINCTURE ORAL 20130325 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ALUMINUM OXIDE; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE 30; 30; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL 68703-093_53952697-6db3-4d73-bc15-b197a79c432f 68703-093 HUMAN OTC DRUG Sinus Soothe Kali bich, Pulsatilla, Hepar sulph, Thuja occ, Spigelia anth TINCTURE ORAL 20130408 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CALCIUM SULFIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SPIGELIA ANTHELMIA; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 6; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 68703-094_f9e1b5d6-a6f3-4d4b-a282-3a5f93e8a337 68703-094 HUMAN OTC DRUG StyeGone Pulsatilla, Staphysagria, Psorinum, Graphites TINCTURE ORAL 20130327 UNAPPROVED HOMEOPATHIC Native Remedies, LLC DELPHINIUM STAPHISAGRIA SEED; GRAPHITE; PULSATILLA VULGARIS; SCABIES LESION LYSATE (HUMAN) 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 68703-095_05bff9ca-58ea-4c94-847b-ebba5d80e5a7 68703-095 HUMAN OTC DRUG Sweat Less Argentum nit, Castoreum, Lupulus, Nat mur, Syphilinum TINCTURE ORAL 20130408 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CASTOR FIBER SCENT GLAND SECRETION; HOPS; SILVER NITRATE; SODIUM CHLORIDE; TREPONEMIC SKIN CANKER HUMAN 30; 30; 6; 6; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL 68703-096_f01db789-926e-4aee-b0f6-d2123e18e7d8 68703-096 HUMAN OTC DRUG Tic Tamer Hyoscyamus, Zinc met, Cina, Chamomilla TINCTURE ORAL 20130329 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARTEMISIA CINA PRE-FLOWERING TOP; HYOSCYAMUS NIGER; MATRICARIA RECUTITA; ZINC 30; 30; 12; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 68703-097_1bc086e7-7bf3-4435-8191-63ad1a117fa7 68703-097 HUMAN OTC DRUG Vagi-Soothe Calc carb, Kreosotum, Lycopodium, Merc sol, Sepia TINCTURE ORAL 20130329 UNAPPROVED MEDICAL GAS Native Remedies, LLC LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE; WOOD CREOSOTE 12; 30; 6; 6; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 68703-098_2e94be05-4919-4788-b554-c9caf8497ac9 68703-098 HUMAN OTC DRUG Vagi-Clear Kali phosphoricum, Kreosotum, Nitricum acidum, Pulsatilla, Sepia TINCTURE ORAL 20130405 UNAPPROVED HOMEOPATHIC Native Remedies, NITRIC ACID; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; WOOD CREOSOTE 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 68703-099_23db1934-668a-4802-ab35-06359ec92272 68703-099 HUMAN OTC DRUG Red Eye Reducer Aconitum napellus, Allium cepa, Ambrosia artemisiaefolia, Apis mellifica, Arsenicum album, Belladonna, Cactus grandiflorus, Dulcamara, Euphrasia officinalis, Gelsemium sempervirens, Graphites, Hamamelis virginiana, Hepar sulphuris calcareum, Kali iodatum, Mercurius vivus, Natrum muriaticum, Pulsatilla, Rhus toxicodendron, Ruta graveolens, Sabadilla, Sulphur, Thuja occidentalis, Zincum metallicum SPRAY ORAL 20130713 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACONITUM NAPELLUS; AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CALCIUM SULFIDE; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MERCURY; ONION; POTASSIUM IODIDE; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; SELENICEREUS GRANDIFLORUS STEM; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-100_86364e60-73a7-447e-9373-4ada1dde0378 68703-100 HUMAN OTC DRUG AppetiteGo Adrenalinum, Adrenocorticotrophin, Agrimonia eupatoria flos, Anacardium orientale, Antimonium crudum, Calcarea carbonica, Castanea sativa flos, Cortisone aceticum, Fucus vesiculosus, Hypothalamus , Kali bichromicum, Oleander, Pituitarum posterium, Sabadilla, Staphysagria, Thyroidinum SPRAY ORAL 20130604 UNAPPROVED HOMEOPATHIC Native Remedies, LLC AGRIMONIA EUPATORIA FLOWER; ANTIMONY TRISULFIDE; BOS TAURUS HYPOTHALAMUS; CASTANEA SATIVA FLOWER; CORTICOTROPIN; CORTISONE ACETATE; DELPHINIUM STAPHISAGRIA SEED; EPINEPHRINE; FUCUS VESICULOSUS; NERIUM OLEANDER LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; SCHOENOCAULON OFFICINALE SEED; SEMECARPUS ANACARDIUM JUICE; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-101_cd809f51-1e5d-4cdc-8acf-6559550ba899 68703-101 HUMAN OTC DRUG BoneBuildPro Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Equisetum hyemale, Hekla lava, Phosphorus, Silicea SPRAY ORAL 20130626 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CALCIUM FLUORIDE; EQUISETUM HYEMALE; HEKLA LAVA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-102_c9e93a53-153e-4005-bcab-871465c6917a 68703-102 HUMAN OTC DRUG AllergyEase Grain and Gluten Arsenicum album, Bryonia alba, Histamimum hydrochloricum, Hydrastis canadensis, Lycopodium clavatum, Natrum muriaticum, Pulsatilla, Sabadilla, Secale cornutum, Sulphur SPRAY ORAL 20130605 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CLAVICEPS PURPUREA SCLEROTIUM; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-103_674ea646-d803-4587-a937-8202693c37e6 68703-103 HUMAN OTC DRUG AllergyEase Northeastern Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Agraphis nutans, Allium cepa, Collinsonia canadensis, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crisp, Sabadilla, Salvia officinalis, Tanacetum vulgare, Trofolium pratense, Vinca minor SPRAY ORAL 20130627 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ADENOSINE CYCLIC PHOSPHATE; COLLINSONIA CANADENSIS ROOT; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; HYACINTHOIDES NON-SCRIPTA; ONION; POTASSIUM CHLORIDE; RUMEX CRISPUS ROOT; SACCHAROMYCES CEREVISIAE RNA; SAGE; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; TANACETUM VULGARE TOP; TRIFOLIUM PRATENSE FLOWER; VINCA MINOR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-104_f8398470-313b-4c72-abcd-4b6c833f70ad 68703-104 HUMAN OTC DRUG TMJ Ease Baptisia tinctoria, Calcarea fluorica, Causticum, Hepar sulphuris calcareum, Hypericum perforatum, Ignatia amara, Kalmia latifolia, Nux vomica, Phytolacca decandra, Rhus toxicodendron, Sanguinaria canadensis, Symphytum officinale SPRAY ORAL 20130627 UNAPPROVED HOMEOPATHIC Native Remedies, LLC BAPTISIA TINCTORIA ROOT; CALCIUM FLUORIDE; CALCIUM SULFIDE; CAUSTICUM; COMFREY ROOT; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; PHYTOLACCA AMERICANA ROOT; SANGUINARIA CANADENSIS ROOT; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; 1/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-105_01309f97-f58e-43fa-8fe8-566eea137072 68703-105 HUMAN OTC DRUG VaricoGo Aesculus hippocastanum, Arnica montana, Calcarea fluorica, Carduus marianus, Carbo vegetabilis, Collinsonia canadensis, Echinacea purpurea, Hamamelis virginiana, Lachesis mutus, Pulsatilla, Secale cornutum SPRAY ORAL 20130626 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACTIVATED CHARCOAL; ARNICA MONTANA; CALCIUM FLUORIDE; CLAVICEPS PURPUREA SCLEROTIUM; COLLINSONIA CANADENSIS ROOT; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SILYBUM MARIANUM SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-106_ed5fd0fd-0872-473e-ad82-7c6486421d92 68703-106 HUMAN OTC DRUG Gallbladder Dr. Berberis vulgaris, Bryonia alba, Carduus marianus, Chelidonium majus, Cholesterinum, Chichona officinalis, Colocynthis, Dioscorea villosa, Lycopodium clavatum, Natrum sulphuricum SPRAY ORAL 20130722 UNAPPROVED HOMEOPATHIC Native Remedies, LLC BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; LYCOPODIUM CLAVATUM SPORE; SILYBUM MARIANUM SEED; SODIUM SULFATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-107_1fdf4ff1-b1b0-46dc-931c-974ef5c01c9f 68703-107 HUMAN OTC DRUG CataractClear Calc carb, Calc fluor, Casuticum, Cineraria, Euphrasia, Napthalinum, Nat mur, Phos, Quassia, Silicea SPRAY ORAL 20130724 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CALCIUM FLUORIDE; CAUSTICUM; EUPHRASIA STRICTA; JACOBAEA MARITIMA; NAPHTHALENE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; QUASSIA AMARA WOOD; SILICON DIOXIDE; SODIUM CHLORIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-108_dae22f30-af57-4cf3-aa2d-968f3626f7d0 68703-108 HUMAN OTC DRUG AllergyEase Desert Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Alfalfa, Allium cepa, Ambrosia artemisiaefolia, Cortisone aceticum, Erechtites hieracifolia, Erigeron canadensis, Euonymus atropurpureus, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Sabadilla, Stramonium, Triticum repens SPRAY ORAL 20130628 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ADENOSINE CYCLIC PHOSPHATE; ALFALFA; AMBROSIA ARTEMISIIFOLIA; CONYZA CANADENSIS; CORTICOTROPIN; CORTISONE ACETATE; DATURA STRAMONIUM; ELYMUS REPENS ROOT; EPINEPHRINE; ERECHTITES HIERACIIFOLIUS; EUONYMUS ATROPURPUREUS BRANCH BARK/ROOT BARK; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; ONION; POTASSIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-109_adcf6864-60dc-4ce7-8a28-02f99c20c193 68703-109 HUMAN OTC DRUG AllergyEase Great Lakes Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemisiaefolia, Chelidonium majus, Chenopodium vulvaria, Cichorium intybus, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Hereda helix, Histaminum hydrochloricum, Junglans cinerea, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Pulsatilla nuttalliana, RNA, Sabadilla, Teucrium scorodonia SPRAY ORAL 20130628 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ADENOSINE CYCLIC PHOSPHATE; AMBROSIA ARTEMISIIFOLIA; ANEMONE PATENS; CHELIDONIUM MAJUS; CHENOPODIUM VULVARIA; CHICORY ROOT; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; ONION; POTASSIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; TEUCRIUM SCORODONIA FLOWERING TOP 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-110_0617f99f-d07e-4bbc-a999-92dd05e4c44d 68703-110 HUMAN OTC DRUG AllergyEase Hawaii Adenosinum cyclophosphoricum, Adrenalium, Adrenocorticotrophin, Allium cepa, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Juniperus virginiana, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Runex crisp, Sabadilla SPRAY ORAL 20130607 UNAPPROVED HOMEOPATHIC Native Remedies ADENOSINE CYCLIC PHOSPHATE; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; ONION; POTASSIUM CHLORIDE; RUMEX CRISPUS ROOT; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-111_8adb5cf3-9e65-4f3c-9c65-32e93fc806fc 68703-111 HUMAN OTC DRUG AllergyEase Pacific Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Alfalfa, Allium cepa, Bellis perennis, Conium maculatum, Cortisone aceticum, Equisetum hyemale, Euphrasia officinalis, Fogopyrum esculentum, Galphimia glauca, Histaminum hydrochloricum, kali muriaticum, Millefolium, Mucosa nasalis suis, Natrum muriaticum, Prunus spinosa, RNA, Sabadilla, Solidago virgaurea SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACHILLEA MILLEFOLIUM; ADENOSINE CYCLIC PHOSPHATE; ALFALFA; BELLIS PERENNIS; CONIUM MACULATUM FLOWERING TOP; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EQUISETUM HYEMALE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; ONION; POTASSIUM CHLORIDE; PRUNUS SPINOSA FLOWER BUD; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA NASAL MUCOSA 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; h/59mL; h/59mL; [hp_X]/59mL; [hp_X]/59mL; h/59mL; [hp_X]/59mL; h/59mL; h/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-112_ba29c138-4083-4c10-a745-c5b0e8f81ee7 68703-112 HUMAN OTC DRUG AllergyEase Plains Absinthium, Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemissfolia, Caulophyllum thalictroides, Conium maculatum, Cortisone aceticum, Euphrasia officinalis, Fagopyrum esculentum, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Melilotus officinalis, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Secale cornutum SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ADENOSINE CYCLIC PHOSPHATE; AMBROSIA ARTEMISIIFOLIA; CAULOPHYLLUM THALICTROIDES ROOT; CLAVICEPS PURPUREA SCLEROTIUM; CONIUM MACULATUM FLOWERING TOP; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; MELILOTUS OFFICINALIS TOP; ONION; POTASSIUM CHLORIDE; RUMEX CRISPUS ROOT; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; WORMWOOD 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-113_7ce80488-ffe6-4c53-bf01-14735dd5766e 68703-113 HUMAN OTC DRUG AllergyEase Rocky Mtns Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Agrimonia eupatoria, Agrostemma githago, Ailanthus glandulosus, Allium cepa, Cortisone aceticum, Cynodon dactylon, Equisetum hyemale, Euprhrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Platanus, Populus candicans, RNA, Sabadilla, Solidago virgaurea SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ADENOSINE CYCLIC PHOSPHATE; AGRIMONIA EUPATORIA; AGROSTEMMA GITHAGO SEED; AILANTHUS ALTISSIMA FLOWERING TWIG; CORTICOTROPIN; CORTISONE ACETATE; CYNODON DACTYLON; EPINEPHRINE; EQUISETUM HYEMALE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; ONION; PLATANUS X ACERIFOLIA WHOLE; POPULUS BALSAMIFERA LEAF BUD; POTASSIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA NASAL MUCOSA 12; 12; 12; 12; 12; 12; 12; 12; 12; 59; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-114_fda2dd63-4370-4614-9e1c-68dfd169db92 68703-114 HUMAN OTC DRUG AllergyEase Southern Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Alnus serrulata, Carduus benedictus, Cichorium intybus, Cortisone aceticum, Dolichos pruriens, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Mucosa nasalis suis, Nasturtium, Natrum muriaticum, Rhus tox, RNA, Sabadilla, Sassafras officinale SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ADENOSINE CYCLIC PHOSPHATE; ALNUS SERRULATA BARK; CENTAUREA BENEDICTA; CHICORY ROOT; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; MUCUNA PRURIENS FRUIT TRICHOME; NASTURTIUM OFFICINALE; ONION; POTASSIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SASSAFRAS ALBIDUM ROOT BARK; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; h/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-115_99d49750-ba00-4005-aa1e-11600f1bc6e3 68703-115 HUMAN OTC DRUG AllergyEase Southwestern Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Asarum canadense, Cortisone aceticum, Eupatorium aromaticum, Euphrasia officinalis, Fraxinus americana, Galphimia glauca, Helianthus annus, Histaminum hydrochloricum, Juniperus virginiana, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Plantago major, RNA, Rumex crispus, Sabadilla, Senecio jacobaea SPRAY ORAL 20130702 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ADENOSINE CYCLIC PHOSPHATE; AGERATINA AROMATICA ROOT; ASARUM CANADENSE ROOT; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; FRAXINUS AMERICANA BARK; GALPHIMIA GLAUCA FLOWERING TOP; HELIANTHUS ANNUUS FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JACOBAEA VULGARIS; JUNIPERUS VIRGINIANA TWIG; ONION; PLANTAGO MAJOR; POTASSIUM CHLORIDE; RUMEX CRISPUS ROOT; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; SUS SCROFA NASAL MUCOSA 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-116_7ef8d2be-6f2a-440c-8ca0-7522d9c86ef9 68703-116 HUMAN OTC DRUG AllergyEase Weather Changes Alumen, Benzoicum acidum, Cadmium sulphuricum, Chelidonium majus, Colchicum autumnale, Dulcamara, Hypothalamus, Manganum aceticum, Mercurius solubilis, Natrum muriaticum, Nitricum acidum, Phosphorus, Ranunculus bulbosus, Rhododendron chrysanthum, Thyroidinum SPRAY ORAL 20130724 UNAPPROVED HOMEOPATHIC Native Remedies, LLC BENZOIC ACID; BOS TAURUS HYPOTHALAMUS; CADMIUM SULFATE; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; MANGANESE ACETATE TETRAHYDRATE; MERCURIUS SOLUBILIS; NITRIC ACID; PHOSPHORUS; POTASSIUM ALUM; RANUNCULUS BULBOSUS; RHODODENDRON AUREUM LEAF; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-117_f87e61c9-0981-45cb-8b3b-5f9267acefaa 68703-117 HUMAN OTC DRUG AllerguEase Food and Chemical Allium sativum, Anacardium orientale, Apis mellifica, Gambogia, Mercuris solubilis, Natrum carbonicum, Nitricum acidum, Nux vomica, Phosphorus, Pulsatilla, Sulphur SPRAY ORAL 20130702 UNAPPROVED HOMEOPATHIC Native Remedies, LLC APIS MELLIFERA; GAMBOGE; GARLIC; MERCURIUS SOLUBILIS; NITRIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-118_8a2169ad-fa57-45ee-be7f-6aef9411687d 68703-118 HUMAN OTC DRUG AllergyEase Animal Hair and Dander Aralia racemosa, Arsenicum album, Histaminum hydrochloricum, Nux vomica, Oleum animale, Phosphorus, Silicea, Sulphur SPRAY ORAL 20130612 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; CERVUS ELAPHUS HORN OIL; HISTAMINE DIHYDROCHLORIDE; PHOSPHORUS; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-119_fa322b3d-482e-4e84-a197-56722865a84b 68703-119 HUMAN OTC DRUG AllergyEase Dairy Aethusa cynapium, Anacardium orientale, Apium graveolens, Calc carbonica, Gambogia, Histaminum hydrochloricum, Hydrastis canadensis, Lac defloratum, Lac vaccinum, Pulsatilla, Sepia, Sulphur SPRAY ORAL 20130612 UNAPPROVED HOMEOPATHIC Native Remedies, LLC AETHUSA CYNAPIUM; CELERY SEED; COW MILK; GAMBOGE; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SKIM MILK; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-120_39702d68-c692-4fb8-bd08-2f29043ce900 68703-120 HUMAN OTC DRUG AllergyEase Dust Mites and Roaches Aralia racemosa, Blatta americana, Blatta orientalis, Chelidonium majus, Hydrastis canadensis, Linum usitatissimum, Phosphorus, Sulphur, Trifolium pratense SPRAY ORAL 20130703 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARALIA RACEMOSA ROOT; BLATTA ORIENTALIS; CHELIDONIUM MAJUS; FLAX SEED; GOLDENSEAL; PERIPLANETA AMERICANA; PHOSPHORUS; SULFUR; TRIFOLIUM PRATENSE FLOWER 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-121_2893d162-1459-4532-9676-cbc68b5b2f51 68703-121 HUMAN OTC DRUG AllergyEase Egg and Meat Calcarea carbonica, Causticum, Chloramphenicolum, Colchicum autumnale, Gambonia, Histaminum hydrochloricum, Hydrastis canadensis, Ichthyolum, Lecithin, Ova tosta, Ovi gallinae pellicula, Pulsatilla, Pyrogenium SPRAY ORAL 20130626 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CAUSTICUM; CHLORAMPHENICOL; COLCHICUM AUTUMNALE BULB; EGG PHOSPHOLIPIDS; EGG SHELL MEMBRANE; EGG SHELL, COOKED; GAMBOGE; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; ICHTHAMMOL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS; RANCID BEEF 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-122_c8284a2e-16a7-46bb-ba7a-4ef4362e5468 68703-122 HUMAN OTC DRUG AllergyEase Scent and Phenol Acetaldehyde, Arsenicum album, Balsamum peruvianum, Calcarea carbonica, Carbolicum acidum, Conium, Coumarinum, Crocus sativus, Histaminum hydrochloricum, Lachesis, Lycopodium, Phosphorus, Sepia SPRAY ORAL 20130729 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACETALDEHYDE; ARSENIC TRIOXIDE; BALSAM PERU; CONIUM MACULATUM FLOWERING TOP; COUMARIN; HISTAMINE DIHYDROCHLORIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHENOL; PHOSPHORUS; SAFFRON; SEPIA OFFICINALIS JUICE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-123_df91ffd7-cbe5-4417-9e99-4fcb8c6e664f 68703-123 HUMAN OTC DRUG AllergyEase Nut and Seed Adrenalinum, Chelidonium majus, Cucurbita pepo semen, Hsitaminum hydrochloricum, Hydrastis canadensis, Ricinus communis, sabadilla SPRAY ORAL 20130729 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CHELIDONIUM MAJUS; EPINEPHRINE; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; PUMPKIN SEED; RICINUS COMMUNIS SEED; SCHOENOCAULON OFFICINALE SEED 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-124_b52f36f0-9fed-4191-b7eb-67552b3bf4e4 68703-124 HUMAN OTC DRUG AllergyEase Shellfish and Seafood Adrenalinum, Belladona, Bromium, Carbo animalis, Colchicum autumnale, Colocynthis, Histaminum hydrochloricum, Hydrstis canadensis, Kali carbonicum, Lycopodium clavatum, Mercuris solubilis, Pulsatilla, Urtica urens SPRAY ORAL 20130613 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ATROPA BELLADONNA; BROMINE; CARBO ANIMALIS; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; EPINEPHRINE; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; URTICA URENS 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-125_a7e25685-6adb-428b-a81f-75b53bc5f496 68703-125 HUMAN OTC DRUG AllergyEase Mold Arsenicum album, Baptisia tinctoria, Chloramphenicolum, Echinacea, Elais guineensis, Hydrastis canadensis, Mercuris solubilis, Myrrha, Nasturtium aquaticum, Nux vomica, Phosphorus, Phytolacca decandra, Pulsatilla, Ricinus communis, Sepia, Xanthoxylum fraxineum SPRAY ORAL 20130729 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CHLORAMPHENICOL; ECHINACEA, UNSPECIFIED; ELAEIS GUINEENSIS FRUIT; GOLDENSEAL; MERCURIUS SOLUBILIS; MYRRH; NASTURTIUM OFFICINALE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RICINUS COMMUNIS SEED; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; ZANTHOXYLUM AMERICANUM BARK 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-126_c621bb47-5e00-45b5-a3ad-b4dcb2f74906 68703-126 HUMAN OTC DRUG Triple Complex Glucose Control Calc phos, Kali sulph, Nat sulphuricum TINCTURE ORAL 20140617 UNAPPROVED HOMEOPATHIC Native Remedies, LLC POTASSIUM SULFATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68703-136_360d54d7-7b65-4908-b65c-36b57b67d821 68703-136 HUMAN OTC DRUG Be-Dry Equisetum arv PELLET ORAL 20130828 UNAPPROVED HOMEOPATHIC Native Remedies, LLC EQUISETUM ARVENSE TOP 6 [hp_C]/19g 68703-137_17f165bf-0cb4-4991-8a79-5800e30dcc7a 68703-137 HUMAN OTC DRUG TremorSoothe Agaricus musc, Mag phos, Stramonium, Tarentula hisp PELLET ORAL 20130828 UNAPPROVED HOMEOPATHIC Native Remedies, LLC AMANITA MUSCARIA FRUITING BODY; DATURA STRAMONIUM; LYCOSA TARANTULA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6; 6; 6; 8 [hp_C]/19g; [hp_C]/19g; [hp_C]/19g; [hp_X]/19g 68703-138_43c49f19-1f04-4bdb-88b0-cf3688ea4ec0 68703-138 HUMAN OTC DRUG BladderWell Apis mel, Cantharis, Equisetum arv, Ferrum phos, Sarsaparilla PELLET ORAL 20130828 UNAPPROVED HOMEOPATHIC Native Remedies, LLC APIS MELLIFERA; EQUISETUM ARVENSE TOP; FERROSOFERRIC PHOSPHATE; LYTTA VESICATORIA; SMILAX REGELII ROOT 30; 30; 8; 30; 30 [hp_C]/19g; [hp_C]/19g; [hp_X]/19g; [hp_C]/19g; [hp_C]/19g 68703-139_8d375ef2-6362-4e35-bdce-9d76a989e5a3 68703-139 HUMAN OTC DRUG ProState Relief Chimaphila umb, Clematis virg, Conium, Cubeba, Sabal PELLET ORAL 20130826 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CHIMAPHILA UMBELLATA; CLEMATIS VIRGINIANA TOP; CONIUM MACULATUM FLOWERING TOP; PIPER CUBEBA FRUIT; SAW PALMETTO 6; 6; 6; 6; 6 [hp_C]/19g; [hp_C]/19g; [hp_C]/19g; [hp_C]/19g; [hp_C]/19g 68703-140_27bf8d0c-610b-4a84-8f70-1d310c5751f5 68703-140 HUMAN OTC DRUG SocialFear Relief Cacao, Gelsemium, Graphites PELLET ORAL 20130820 UNAPPROVED HOMEOPATHIC Native Remedies, LLC COCOA; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE 30; 30; 30 [hp_C]/19g; [hp_C]/19g; [hp_C]/19g 68703-151_4320549b-df93-4ea1-8f81-ce2f21dcdd2b 68703-151 HUMAN OTC DRUG EyeClear Pro Calc carb, Calc fluor, Casuticum, Cineraria, Euphrasia, Napthalinum, Nat mur, Phos, Quassia, Silicea SPRAY ORAL 20140712 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CALCIUM FLUORIDE; CAUSTICUM; EUPHRASIA STRICTA; JACOBAEA MARITIMA; NAPHTHALENE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; QUASSIA AMARA WOOD; SILICON DIOXIDE; SODIUM CHLORIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 68703-153_89aa506d-64d5-4c44-8ef1-0f3a2d3ca183 68703-153 HUMAN OTC DRUG SciatiGon-M Aconitum napellus, Berberis vulgaris, Chamomilla, Colocynthis, Magnesia phosphorica, Rhus toxicodendron TINCTURE ORAL 20141207 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACONITUM NAPELLUS; BERBERIS VULGARIS ROOT BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; TOXICODENDRON PUBESCENS LEAF 6; 3; 30; 8; 2; 30 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL 68712-003_6c590b36-e9af-4df8-922e-1616900acdee 68712-003 HUMAN PRESCRIPTION DRUG Aclaro Hydroquinone Hydroquinone EMULSION TOPICAL 20040601 UNAPPROVED DRUG OTHER Innocutis HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 68712-004_03808cdc-9792-43c5-b50d-80a9f7f0e8c3 68712-004 HUMAN PRESCRIPTION DRUG Umecta Urea Urea EMULSION TOPICAL 20040601 UNAPPROVED DRUG OTHER Innocutis Holdings LLC UREA 400 mg/g 68712-005_65b23d9e-800e-4c12-bea9-6087c68f283b 68712-005 HUMAN PRESCRIPTION DRUG Umecta Urea Urea SUSPENSION TOPICAL 20040601 UNAPPROVED DRUG OTHER Innocutis Holdings, LLC UREA 400 mg/g 68712-010_fdccb6dc-4a61-4eec-8f5e-ec9129e4309e 68712-010 HUMAN PRESCRIPTION DRUG Umecta Urea Urea FILM TOPICAL 20060601 UNAPPROVED DRUG OTHER Innocutis Holdings LLC UREA 400 mg/g 68712-015_eb831083-6566-47bd-ba84-6211b0c86f06 68712-015 HUMAN PRESCRIPTION DRUG Aclaro PD Hydroquinone Hydroquinone EMULSION TOPICAL 20110401 UNAPPROVED DRUG OTHER Innocutis Holdings LLC HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 68712-017_da03771c-15c5-4bcc-8d22-6aec7033182e 68712-017 HUMAN PRESCRIPTION DRUG Umecta PD Urea Urea EMULSION TOPICAL 20070601 UNAPPROVED DRUG OTHER Innocutis Holdings LLC UREA 400 mg/g 68712-018_a8911b59-8789-45f3-88e3-d812eb5755a8 68712-018 HUMAN PRESCRIPTION DRUG Umecta PD Urea Urea SUSPENSION TOPICAL 20070601 UNAPPROVED DRUG OTHER Innocutis Holdings LLC UREA 400 mg/g 68712-020_0e33cbf4-abba-49e1-9ade-8c3e4a7358e5 68712-020 HUMAN PRESCRIPTION DRUG Umecta Mousse Urea Urea Foam AEROSOL, FOAM TOPICAL 20070901 UNAPPROVED DRUG OTHER Innocutis Holdings LLC UREA 400 mg/g 68712-027_b367ac0c-2c88-4c37-809b-da4297a47cc6 68712-027 HUMAN PRESCRIPTION DRUG CNL8 Ciclopirox SOLUTION TOPICAL 20081031 ANDA ANDA078270 Innocutis Holdings LLC CICLOPIROX 2.28 g/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 68712-034_9e2a4c23-6765-41bb-9264-70a575bacff3 68712-034 HUMAN PRESCRIPTION DRUG Halonate Halobetasol OINTMENT TOPICAL 20090801 ANDA ANDA077721 Innocutis Holding LLC HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68712-037_6646577b-d69b-4fd1-83b9-786f0488ebb3 68712-037 HUMAN PRESCRIPTION DRUG Terbinex Terbinafine Hydrochloride TABLET ORAL 20090131 ANDA ANDA077533 Innocutis TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 68712-042_4f228fb5-84b5-4661-8630-a740b3591575 68712-042 HUMAN PRESCRIPTION DRUG Halonate Pac Halobetasol OINTMENT TOPICAL 20100501 ANDA ANDA077721 Innocutis Holdings LLC HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68712-049_fce6c25f-1dcd-4e56-a73e-f77307531128 68712-049 HUMAN PRESCRIPTION DRUG Sitavig Acyclovir TABLET, DELAYED RELEASE BUCCAL 20140320 NDA NDA203791 Innocutis Holdings, LLC ACYCLOVIR 50 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68715-084_220ba6dc-ab4d-4b63-ab2b-392efbb4970f 68715-084 HUMAN OTC DRUG Derma Doctor Born to be Mild Cleanser Pyrithione Zinc GEL TOPICAL 20051201 OTC MONOGRAPH FINAL part358H DERMAdoctor PYRITHIONE ZINC 2 g/100mL 68723-306_681cc3eb-5f80-4c84-88fc-f19688b748b8 68723-306 HUMAN OTC DRUG Benzoyl Peroxide 10% Gel Benzoyl Peroxide GEL TOPICAL 20141001 OTC MONOGRAPH FINAL part333D Axia Medical Solutions, LLC BENZOYL PEROXIDE 100 mg/g 68726-068_7bdabc2c-5179-494e-a2de-27019810c058 68726-068 HUMAN OTC DRUG PCA SKIN ACNE SALICYLIC ACID GEL TOPICAL 20040501 OTC MONOGRAPH FINAL part333D Physicians Care Alliance dba PCA Skin SALICYLIC ACID 2 g/100mL 68726-167_846e82e7-c15a-4524-ae0e-f70a13009034 68726-167 HUMAN OTC DRUG PCA SKIN Body Hydrator SPF30 Zinc Oxide and Octinoxate LOTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 Physicians Care Alliance, LLC DBA PCA SKIN OCTINOXATE; ZINC OXIDE 7.5; 9.8 g/100g; g/100g 68726-169_e2b4cd0c-1ec6-4b4d-8573-4006dfacc70c 68726-169 HUMAN OTC DRUG PCA SKIN Acne Benzoyl Perozide CREAM TOPICAL 20100401 OTC MONOGRAPH FINAL part333D Physicians Care Alliance DBA PCA SKIN BENZOYL PEROXIDE 5 g/100g 68727-100_4ae8a42b-e6a0-4ee8-a35f-1226a54bf760 68727-100 HUMAN PRESCRIPTION DRUG Xyrem sodium oxybate SOLUTION ORAL 20020717 NDA NDA021196 Jazz Pharmaceuticals, Inc. SODIUM OXYBATE .5 g/mL Central Nervous System Depressant [EPC],Central Nervous System Depression [PE],Decreased Central Nervous System Organized Electrical Activity [PE] CIII 68727-600_fe0df22b-33c7-496c-b6c8-a16691af4f62 68727-600 HUMAN PRESCRIPTION DRUG Luvox CR fluvoxamine maleate CAPSULE, EXTENDED RELEASE ORAL 20080228 NDA NDA022033 Jazz Pharmaceuticals, Inc. FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68727-601_fe0df22b-33c7-496c-b6c8-a16691af4f62 68727-601 HUMAN PRESCRIPTION DRUG Luvox CR fluvoxamine maleate CAPSULE, EXTENDED RELEASE ORAL 20080228 NDA NDA022033 Jazz Pharmaceuticals, Inc. FLUVOXAMINE MALEATE 150 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68737-223_432a298f-3538-4980-9421-c9a75f57ff77 68737-223 HUMAN OTC DRUG Allergy Get Relief Diphenhydramine Hydrochloride TABLET ORAL 20120630 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 68737-224_8bf7e7ac-aa38-4ba5-8c4f-55d15e27f7b0 68737-224 HUMAN OTC DRUG PM Get Relief Acetaminophen and Diphenhydramine Hydrochloride TABLET ORAL 20120630 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 68737-225_2596b3d9-3b6c-4325-9a9d-dfe4bb3c3e91 68737-225 HUMAN OTC DRUG ConRx Allergy Sinus Multi-Symptoms Acetaminophen, Chlorpheniramine maleate, and Phenylephrine Hydrochloride TABLET ORAL 20120711 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 68737-226_896dcc9f-86b2-4fbd-8bf4-22d7c15b43a2 68737-226 HUMAN OTC DRUG ConRx Sinus Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20120711 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 68737-227_027ea3a1-9733-468e-9ae5-872c11381309 68737-227 HUMAN OTC DRUG ConRx Cold Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20120710 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 68737-229_c4310dbf-b2cf-4d72-a63a-11b34b148aef 68737-229 HUMAN OTC DRUG ConRx Alert Caffeine TABLET ORAL 20130215 OTC MONOGRAPH FINAL part340 Eagle Distributors,Inc. CAFFEINE 200 mg/1 68737-230_ba486804-de1f-4762-959a-42aa87259b98 68737-230 HUMAN OTC DRUG ConRx Allergy Diphenhydramine Hydrochloride TABLET ORAL 20130215 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 68737-231_2eee76ce-e881-4ca7-b7d5-2dbf60dbff77 68737-231 HUMAN OTC DRUG ConRx Allergy Sinus Acetaminophen, Chlorpheniramine maleate, and Phenylephrine Hydrochloride TABLET ORAL 20130215 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 68737-232_fe6658d7-6785-4f88-b192-36ae6f8e11ca 68737-232 HUMAN OTC DRUG ConRx Cold Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20130215 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 68737-233_4be86d0c-da24-4a2a-ab46-43c657d1d986 68737-233 HUMAN OTC DRUG ConRx Extra Strength Acetaminophen TABLET ORAL 20130215 OTC MONOGRAPH NOT FINAL part343 Eagle Distributors,Inc. ACETAMINOPHEN 500 mg/1 68737-234_a4c899e8-155f-4dd0-a8a5-002aba7230d6 68737-234 HUMAN OTC DRUG ConRx pain Reliever Acetaminophen, Aspirin, and Caffeine TABLET ORAL 20130215 OTC MONOGRAPH FINAL part343 Eagle Distributors,Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 68737-235_e0d78b48-3e06-408b-ac88-3461cf878645 68737-235 HUMAN OTC DRUG ConRx PM Acetaminophen and Diphenhydramine Hydrochloride TABLET ORAL 20130215 OTC MONOGRAPH FINAL part338 Eagle Distributors,Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 68737-236_c46d5213-7c5b-4435-9fac-c2323e6e1699 68737-236 HUMAN OTC DRUG ConRx Sinus Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20130215 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 68737-237_71fe9cd2-cd77-406e-9dc9-9d977871ae01 68737-237 HUMAN OTC DRUG ConRx AR ALUMINUM HYDROXIDE and MAGNESIUM HYDROXIDE TABLET, CHEWABLE ORAL 20130318 OTC MONOGRAPH FINAL part331 Eagle Distributors,Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE 160; 105 mg/1; mg/1 68737-238_13b8d214-6167-49c7-bca3-acb3ea7515a5 68737-238 HUMAN OTC DRUG ConRX DayTime Phenylephrine Hydrochloride, Acetaminophen, Dextromethorphan Hydrobromide, and Guaifenesin TABLET ORAL 20140131 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 68737-239_490fee50-f524-48dc-ad57-8bfa983f9e46 68737-239 HUMAN OTC DRUG ConRx NightTime Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate TABLET ORAL 20140210 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 68737-240_ba30bedb-b54d-447c-a17c-088c0fe5cd38 68737-240 HUMAN OTC DRUG ConRX Pain Reliever Sinus Headache Phenylephrine Hydrochloride and Acetaminophen TABLET ORAL 20140131 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 68745-1018_d3a6b963-ef1d-4219-ac47-9989a14b6339 68745-1018 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 12 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL 68745-1019_d3a6b963-ef1d-4219-ac47-9989a14b6339 68745-1019 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 22 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL 68745-1020_d3a6b963-ef1d-4219-ac47-9989a14b6339 68745-1020 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 32 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL 68745-1021_d3a6b963-ef1d-4219-ac47-9989a14b6339 68745-1021 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 42 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL 68745-1022_d3a6b963-ef1d-4219-ac47-9989a14b6339 68745-1022 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 52 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL 68745-1023_d3a6b963-ef1d-4219-ac47-9989a14b6339 68745-1023 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 10 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL 68745-1024_d3a6b963-ef1d-4219-ac47-9989a14b6339 68745-1024 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 20 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL 68745-1025_d3a6b963-ef1d-4219-ac47-9989a14b6339 68745-1025 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 30 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL 68745-1026_d3a6b963-ef1d-4219-ac47-9989a14b6339 68745-1026 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 40 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL 68745-1027_d3a6b963-ef1d-4219-ac47-9989a14b6339 68745-1027 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 50 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL 68745-1034_c01c3235-ce5d-4f00-9d64-c90c5019626d 68745-1034 HUMAN OTC DRUG VITALUMIERE MOISTURE-RICH RADIANCE SUNSCREEN FLUID MAKEUP, BROAD SPECTRUM SPF 15, 20 CLAIR OCTINOXATE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 50 mg/mL 68745-1035_c01c3235-ce5d-4f00-9d64-c90c5019626d 68745-1035 HUMAN OTC DRUG VITALUMIERE MOISTURE-RICH RADIANCE SUNSCREEN FLUID MAKEUP, BROAD SPECTRUM SPF 15, 30 CENDRE OCTINOXATE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 50 mg/mL 68745-1036_c01c3235-ce5d-4f00-9d64-c90c5019626d 68745-1036 HUMAN OTC DRUG VITALUMIERE MOISTURE-RICH RADIANCE SUNSCREEN FLUID MAKEUP, BROAD SPECTRUM SPF 15, 40 BEIGE OCTINOXATE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 50 mg/mL 68745-1037_c01c3235-ce5d-4f00-9d64-c90c5019626d 68745-1037 HUMAN OTC DRUG VITALUMIERE MOISTURE-RICH RADIANCE SUNSCREEN FLUID MAKEUP, BROAD SPECTRUM SPF 15, 50 NATUREL OCTINOXATE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 50 mg/mL 68745-1038_c01c3235-ce5d-4f00-9d64-c90c5019626d 68745-1038 HUMAN OTC DRUG VITALUMIERE MOISTURE-RICH RADIANCE SUNSCREEN FLUID MAKEUP, BROAD SPECTRUM SPF 15, 07 IVOIRE OCTINOXATE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 50 mg/mL 68745-1039_c01c3235-ce5d-4f00-9d64-c90c5019626d 68745-1039 HUMAN OTC DRUG VITALUMIERE MOISTURE-RICH RADIANCE SUNSCREEN FLUID MAKEUP, BROAD SPECTRUM SPF 15, 35 SOFT BISQUE OCTINOXATE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 50 mg/mL 68745-1040_c01c3235-ce5d-4f00-9d64-c90c5019626d 68745-1040 HUMAN OTC DRUG VITALUMIERE MOISTURE-RICH RADIANCE SUNSCREEN FLUID MAKEUP, BROAD SPECTRUM SPF 15, 41 NATURAL BEIGE OCTINOXATE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 50 mg/mL 68745-1041_c01c3235-ce5d-4f00-9d64-c90c5019626d 68745-1041 HUMAN OTC DRUG VITALUMIERE MOISTURE-RICH RADIANCE SUNSCREEN FLUID MAKEUP, BROAD SPECTRUM SPF 15, 51 TAWNY BEIGE OCTINOXATE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 50 mg/mL 68745-1042_ec791a81-0e76-4f02-96ba-21e791522b70 68745-1042 HUMAN OTC DRUG LIFT LUMIERE FIRMING AND SMOOTHING SUNSCREEN FLUID MAKEUP BROAD SPECTRUM SPF 15, 14 IVOIRE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 2.25; 1.68 mL/30mL; mL/30mL 68745-1043_ec791a81-0e76-4f02-96ba-21e791522b70 68745-1043 HUMAN OTC DRUG LIFT LUMIERE FIRMING AND SMOOTHING SUNSCREEN FLUID MAKEUP BROAD SPECTRUM SPF 15, 20 CLAIR OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 2.25; 1.68 mL/30mL; mL/30mL 68745-1044_ec791a81-0e76-4f02-96ba-21e791522b70 68745-1044 HUMAN OTC DRUG LIFT LUMIERE FIRMING AND SMOOTHING SUNSCREEN FLUID MAKEUP BROAD SPECTRUM SPF 15, 30 CENDRE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 2.25; 1.68 mL/30mL; mL/30mL 68745-1045_ec791a81-0e76-4f02-96ba-21e791522b70 68745-1045 HUMAN OTC DRUG LIFT LUMIERE FIRMING AND SMOOTHING SUNSCREEN FLUID MAKEUP BROAD SPECTRUM SPF 15, 40 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 2.25; 1.68 mL/30mL; mL/30mL 68745-1046_ec791a81-0e76-4f02-96ba-21e791522b70 68745-1046 HUMAN OTC DRUG LIFT LUMIERE FIRMING AND SMOOTHING SUNSCREEN FLUID MAKEUP BROAD SPECTRUM SPF 15, 47 NATURAL BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 2.25; 1.68 mL/30mL; mL/30mL 68745-1047_ec791a81-0e76-4f02-96ba-21e791522b70 68745-1047 HUMAN OTC DRUG LIFT LUMIERE FIRMING AND SMOOTHING SUNSCREEN FLUID MAKEUP BROAD SPECTRUM SPF 15, 50 NATUREL OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 2.25; 1.68 mL/30mL; mL/30mL 68745-1048_ec791a81-0e76-4f02-96ba-21e791522b70 68745-1048 HUMAN OTC DRUG LIFT LUMIERE FIRMING AND SMOOTHING SUNSCREEN FLUID MAKEUP BROAD SPECTRUM SPF 15, 66 TAWNY BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 2.25; 1.68 mL/30mL; mL/30mL 68745-1049_ec791a81-0e76-4f02-96ba-21e791522b70 68745-1049 HUMAN OTC DRUG LIFT LUMIERE FIRMING AND SMOOTHING SUNSCREEN FLUID MAKEUP BROAD SPECTRUM SPF 15, 41 SOFT BISQUE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 2.25; 1.68 mL/30mL; mL/30mL 68745-1050_21f692db-ec83-43eb-bc01-4c2cbf5d3574 68745-1050 HUMAN OTC DRUG VITALUMIERE AQUA FRESH AND HYDRATING COMPACT SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 22 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .48; .612 g/12g; g/12g 68745-1051_21f692db-ec83-43eb-bc01-4c2cbf5d3574 68745-1051 HUMAN OTC DRUG VITALUMIERE AQUA FRESH AND HYDRATING COMPACT SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 32 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .48; .612 g/12g; g/12g 68745-1052_21f692db-ec83-43eb-bc01-4c2cbf5d3574 68745-1052 HUMAN OTC DRUG VITALUMIERE AQUA FRESH AND HYDRATING COMPACT SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 42 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .48; .612 g/12g; g/12g 68745-1053_21f692db-ec83-43eb-bc01-4c2cbf5d3574 68745-1053 HUMAN OTC DRUG VITALUMIERE AQUA FRESH AND HYDRATING COMPACT SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 52 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .48; .612 g/12g; g/12g 68745-1054_21f692db-ec83-43eb-bc01-4c2cbf5d3574 68745-1054 HUMAN OTC DRUG VITALUMIERE AQUA FRESH AND HYDRATING COMPACT SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 10 BEIGE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .48; .612 g/12g; g/12g 68745-1055_21f692db-ec83-43eb-bc01-4c2cbf5d3574 68745-1055 HUMAN OTC DRUG VITALUMIERE AQUA FRESH AND HYDRATING COMPACT SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 20 BEIGE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .48; .612 g/12g; g/12g 68745-1056_21f692db-ec83-43eb-bc01-4c2cbf5d3574 68745-1056 HUMAN OTC DRUG VITALUMIERE AQUA FRESH AND HYDRATING COMPACT SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 30 BEIGE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .48; .612 g/12g; g/12g 68745-1057_21f692db-ec83-43eb-bc01-4c2cbf5d3574 68745-1057 HUMAN OTC DRUG VITALUMIERE AQUA FRESH AND HYDRATING COMPACT SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 40 BEIGE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .48; .612 g/12g; g/12g 68745-1058_21f692db-ec83-43eb-bc01-4c2cbf5d3574 68745-1058 HUMAN OTC DRUG VITALUMIERE AQUA FRESH AND HYDRATING COMPACT SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 50 BEIGE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .48; .612 g/12g; g/12g 68745-1059_21f692db-ec83-43eb-bc01-4c2cbf5d3574 68745-1059 HUMAN OTC DRUG VITALUMIERE AQUA FRESH AND HYDRATING COMPACT SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 60 BEIGE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .48; .612 g/12g; g/12g 68745-1062_55332fb6-aeb9-4060-85a9-0bb48ce8290a 68745-1062 HUMAN OTC DRUG PERFECTION LUMIERE LONG-WEAR FLAWLESS FLUID SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 114 AMBRE TITANIUM DIOXIDE EMULSION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE 31 mg/mL 68745-1065_55332fb6-aeb9-4060-85a9-0bb48ce8290a 68745-1065 HUMAN OTC DRUG PERFECTION LUMIERE LONG-WEAR FLAWLESS FLUID SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 12 BEIGE ROSE TITANIUM DIOXIDE EMULSION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE 31 mg/mL 68745-1066_55332fb6-aeb9-4060-85a9-0bb48ce8290a 68745-1066 HUMAN OTC DRUG PERFECTION LUMIERE LONG-WEAR FLAWLESS FLUID SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 22 BEIGE ROSE TITANIUM DIOXIDE EMULSION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE 31 mg/mL 68745-1067_55332fb6-aeb9-4060-85a9-0bb48ce8290a 68745-1067 HUMAN OTC DRUG PERFECTION LUMIERE LONG-WEAR FLAWLESS FLUID SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 32 BEIGE ROSE TITANIUM DIOXIDE EMULSION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE 31 mg/mL 68745-1068_55332fb6-aeb9-4060-85a9-0bb48ce8290a 68745-1068 HUMAN OTC DRUG PERFECTION LUMIERE LONG-WEAR FLAWLESS FLUID SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 42 BEIGE ROSE TITANIUM DIOXIDE EMULSION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE 31 mg/mL 68745-1069_55332fb6-aeb9-4060-85a9-0bb48ce8290a 68745-1069 HUMAN OTC DRUG PERFECTION LUMIERE LONG-WEAR FLAWLESS FLUID SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 52 BEIGE ROSE TITANIUM DIOXIDE EMULSION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE 31 mg/mL 68745-1070_55332fb6-aeb9-4060-85a9-0bb48ce8290a 68745-1070 HUMAN OTC DRUG PERFECTION LUMIERE LONG-WEAR FLAWLESS FLUID SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 10 BEIGE TITANIUM DIOXIDE EMULSION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE 31 mg/mL 68745-1087_55332fb6-aeb9-4060-85a9-0bb48ce8290a 68745-1087 HUMAN OTC DRUG PERFECTION LUMIERE LONG-WEAR FLAWLESS FLUID SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 20 BEIGE TITANIUM DIOXIDE EMULSION TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE 31 mg/mL 68745-1088_55332fb6-aeb9-4060-85a9-0bb48ce8290a 68745-1088 HUMAN OTC DRUG PERFECTION LUMIERE LONG-WEAR FLAWLESS FLUID SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 30 BEIGE TITANIUM DIOXIDE EMULSION TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE 31 mg/mL 68745-1089_55332fb6-aeb9-4060-85a9-0bb48ce8290a 68745-1089 HUMAN OTC DRUG PERFECTION LUMIERE LONG-WEAR FLAWLESS FLUID SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 40 BEIGE TITANIUM DIOXIDE EMULSION TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE 31 mg/mL 68745-1090_55332fb6-aeb9-4060-85a9-0bb48ce8290a 68745-1090 HUMAN OTC DRUG PERFECTION LUMIERE LONG-WEAR FLAWLESS FLUID SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 60 BEIGE TITANIUM DIOXIDE EMULSION TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE 31 mg/mL 68745-1091_55332fb6-aeb9-4060-85a9-0bb48ce8290a 68745-1091 HUMAN OTC DRUG PERFECTION LUMIERE LONG-WEAR FLAWLESS FLUID SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 70 BEIGE TITANIUM DIOXIDE EMULSION TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE 31 mg/mL 68745-1092_55332fb6-aeb9-4060-85a9-0bb48ce8290a 68745-1092 HUMAN OTC DRUG PERFECTION LUMIERE LONG-WEAR FLAWLESS FLUID SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 80 BEIGE TITANIUM DIOXIDE EMULSION TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE 31 mg/mL 68745-1093_73463ea4-68ac-4e26-9c1b-c31217db9229 68745-1093 HUMAN OTC DRUG UV ESSENTIEL COMPLETE SUNSCREEN UV PROTECTION ANTI-POLLUTION BROAD SPECTRUM SPF 20 ENSULIZOLE, OCTINOXATE, and TITANIUM DIOXIDE EMULSION TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 30; 20; 102 mg/mL; mg/mL; mg/mL 68745-1094_62c222d0-404f-45a0-895e-8e5ff14e2f78 68745-1094 HUMAN OTC DRUG UV ESSENTIEL COMPLETE SUNSCREEN UV PROTECTION ANTI-POLLUTION BROAD SPECTRUM SPF 30 ENSULIZOLE, OCTINOXATE, and TITANIUM DIOXIDE EMULSION TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 27; 20; 126 mg/mL; mg/mL; mg/mL 68745-1095_32f5b9a8-43d4-48af-88f7-047f0aca91c8 68745-1095 HUMAN OTC DRUG UV ESSENTIEL COMPLETE SUNSCREEN UV PROTECTION ANTI-POLLUTION BROAD SPECTRUM SPF 50 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE EMULSION TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 75; 16; 171 mg/mL; mg/mL; mg/mL 68745-1101_7d75fbeb-c850-4d03-8818-aae9e2781f57 68745-1101 HUMAN OTC DRUG AQUALUMIERE SPF 15 SHEER COLOUR LIPSHINE LIPSTICK TOPICAL 20040401 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE AVOBENZONE; OCTINOXATE .035; .2625 g/3.5g; g/3.5g 68745-1125_2e2c7970-11ef-469e-8b76-1e70bad1d651 68745-1125 HUMAN OTC DRUG BEAUTE INITIALE SPF 15 ENERGIZING MULTI-PROTECTION CREAM CREAM TOPICAL 20070801 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE AVOBENZONE; OCTINOXATE 1; 3.75 g/50g; g/50g 68745-1126_d9742499-2ecc-4817-af0f-c7cce94a0e60 68745-1126 HUMAN OTC DRUG BEAUTE INITIALE SPF 15 Energizing Multi-Protection Fluid EMULSION TOPICAL 20080701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE AVOBENZONE; OCTINOXATE 1; 3.75 mL/50mL; mL/7.5mL 68745-1127_094c2eba-ded1-4ed5-a7f7-a7bdedb2e519 68745-1127 HUMAN OTC DRUG BEAUTE INITIALE SPF 15 Energizing Multi-Protection Healthy Glow Fluid EMULSION TOPICAL 20080701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE AVOBENZONE; OCTINOXATE 1.5; 3.75 mL/50mL; mL/50mL 68745-1128_49a2b2f7-eb84-43ba-855f-99cc1b0b4580 68745-1128 HUMAN OTC DRUG BEAUTE INITIALE SPF 15 Energizing Multi-Protection Eye Cream CREAM TOPICAL 20080701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE AVOBENZONE; OCTINOXATE .45; 1.125 mL/15mL; mL/15mL 68745-1131_32cbf0b7-ff93-4ef1-97a9-d35b50388ef9 68745-1131 HUMAN OTC DRUG ULTRA CORRECTION LINE REPAIR SPF 15 ANTI-WRINKLE DAY CREAM CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE AVOBENZONE; OCTINOXATE 1.5; 3.75 g/50g; g/50g 68745-1132_ba3e4c65-fb28-42bc-9a1a-08224ff23da4 68745-1132 HUMAN OTC DRUG ULTRA CORRECTION SPF 15 ANTI-WRINKLE DAY FLUID EMULSION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE AVOBENZONE; OCTINOXATE 1.5; 3.75 mL/50mL; mL/50mL 68745-1133_761a168d-985b-48b9-b69b-17246bc935a4 68745-1133 HUMAN OTC DRUG ULTRA CORRECTION LIFT SPF 15 Lifting Firming Day Cream CREAM TOPICAL 20090903 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE AVOBENZONE; OCTINOXATE 1.5; 3.75 g/50g; g/50g 68745-1134_639a405f-80d6-426f-8be1-ec203a373dad 68745-1134 HUMAN OTC DRUG ULTRA CORRECTION LIFT SPF 15 LIFTING FIRMING DAY FLUID EMULSION TOPICAL 20090903 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE AVOBENZONE; OCTINOXATE 1.5; 3.75 mL/50mL; mL/50mL 68745-1141_09eb2e66-dd3e-4448-9b31-66d86dac617e 68745-1141 HUMAN OTC DRUG HYDRAMAX ACTIVE TEINTE SPF 15 Active Moisture Tinted Lotion LOTION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; OXYBENZONE 3; .8 mL/40mL; mL/40mL 68745-1145_816f9c84-04ed-427d-bed1-3cff78036da7 68745-1145 HUMAN OTC DRUG VITALUMIERE SPF 15 Moisture-Rich Fluid Makeup EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 1.5 mL/30mL 68745-1150_0be4a0c6-d43d-43b9-9152-bc0a69e4ea42 68745-1150 HUMAN OTC DRUG UV ESSENTIEL SPF 50 Multi-Protection Daily UV Care EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.25; .6; 5.13 mL/30mL; mL/30mL; mL/30mL 68745-1151_e8cc1c8c-f6ef-416e-8649-2ee8b85f0065 68745-1151 HUMAN OTC DRUG ULTRA CORRECTION LINE REPAIR SPF 15 ANTI-WRINKLE DAY CREAM CREAM TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE AVOBENZONE; OCTINOXATE 1.5; 3.75 g/50g; g/50g 68745-1152_9f1bf2c9-2197-4f01-9d92-256c31cd9948 68745-1152 HUMAN OTC DRUG VITALUMIERE AQUA SPF 15 ULTRA-LIGHT SKIN PERFECTING MAKEUP LIQUID TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 1.8; 1.68 mL/30mL; mL/30mL 68745-1153_9f148490-c610-4a79-8bc8-3c1802026847 68745-1153 HUMAN OTC DRUG PERFECTION LUMIERE Long-Wear Flawless Fluid Makeup SPF 10 Titanium Dioxide EMULSION TOPICAL 20110905 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE .93 mL/30mL 68745-1154_bda3ab19-f62f-451f-85de-b4bb55275a6b 68745-1154 HUMAN OTC DRUG LIFT LUMIERE FIRMING AND SMOOTHING FLUID MAKEUP SPF 15 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20090112 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 2.25; 1.68 mL/30mL; mL/30mL 68745-1155_b652fca3-30d3-463b-845f-109ce59b5e3c 68745-1155 HUMAN OTC DRUG MAT LUMIERE LONG-LASTING SOFT MATTE MAKEUP TITANIUM DIOXIDE EMULSION TOPICAL 20080114 OTC MONOGRAPH NOT FINAL part352 CHANEL PARUMS BEAUTE TITANIUM DIOXIDE 1.8 mL/30mL 68745-1156_bc09cd57-261c-4e57-8ce8-2925c924b481 68745-1156 HUMAN OTC DRUG VITALUMIERE AQUA FRESH AND HYDRATING CREAM COMPACT MAKEUP OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .48; .612 g/12g; g/12g 68745-2001_3e8ec8d5-0a76-405c-919c-d8d6e34f4c3a 68745-2001 HUMAN OTC DRUG DOUBLE PERFECTION LUMIERE LONG-WEAR FLAWLESS SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 12 BEIGE ROSE TITANIUM DIOXIDE POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE .494 g/13g 68745-2002_3e8ec8d5-0a76-405c-919c-d8d6e34f4c3a 68745-2002 HUMAN OTC DRUG DOUBLE PERFECTION LUMIERE LONG-WEAR FLAWLESS SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 22 BEIGE ROSE TITANIUM DIOXIDE POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE .494 g/13g 68745-2003_3e8ec8d5-0a76-405c-919c-d8d6e34f4c3a 68745-2003 HUMAN OTC DRUG DOUBLE PERFECTION LUMIERE LONG-WEAR FLAWLESS SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 32 BEIGE ROSE TITANIUM DIOXIDE POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE .494 g/13g 68745-2004_3e8ec8d5-0a76-405c-919c-d8d6e34f4c3a 68745-2004 HUMAN OTC DRUG DOUBLE PERFECTION LUMIERE LONG-WEAR FLAWLESS SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 35 BEIGE ROSE TITANIUM DIOXIDE POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE .494 g/13g 68745-2005_3e8ec8d5-0a76-405c-919c-d8d6e34f4c3a 68745-2005 HUMAN OTC DRUG DOUBLE PERFECTION LUMIERE LONG-WEAR FLAWLESS SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 42 BEIGE ROSE TITANIUM DIOXIDE POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE .494 g/13g 68745-2006_3e8ec8d5-0a76-405c-919c-d8d6e34f4c3a 68745-2006 HUMAN OTC DRUG DOUBLE PERFECTION LUMIERE LONG-WEAR FLAWLESS SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 52 BEIGE ROSE TITANIUM DIOXIDE POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE .494 g/13g 68745-2007_3e8ec8d5-0a76-405c-919c-d8d6e34f4c3a 68745-2007 HUMAN OTC DRUG DOUBLE PERFECTION LUMIERE LONG-WEAR FLAWLESS SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 62 BEIGE ROSE TITANIUM DIOXIDE POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE .494 g/13g 68745-2008_3e8ec8d5-0a76-405c-919c-d8d6e34f4c3a 68745-2008 HUMAN OTC DRUG DOUBLE PERFECTION LUMIERE LONG-WEAR FLAWLESS SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 10 BEIGE TITANIUM DIOXIDE POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE .494 g/13g 68745-2009_3e8ec8d5-0a76-405c-919c-d8d6e34f4c3a 68745-2009 HUMAN OTC DRUG DOUBLE PERFECTION LUMIERE LONG-WEAR FLAWLESS SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 20 BEIGE TITANIUM DIOXIDE POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE .494 g/13g 68745-2010_3e8ec8d5-0a76-405c-919c-d8d6e34f4c3a 68745-2010 HUMAN OTC DRUG DOUBLE PERFECTION LUMIERE LONG-WEAR FLAWLESS SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 30 BEIGE TITANIUM DIOXIDE POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE .494 g/13g 68745-2011_3e8ec8d5-0a76-405c-919c-d8d6e34f4c3a 68745-2011 HUMAN OTC DRUG DOUBLE PERFECTION LUMIERE LONG-WEAR FLAWLESS SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 40 BEIGE TITANIUM DIOXIDE POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE .494 g/13g 68745-2012_3e8ec8d5-0a76-405c-919c-d8d6e34f4c3a 68745-2012 HUMAN OTC DRUG DOUBLE PERFECTION LUMIERE LONG-WEAR FLAWLESS SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 60 BEIGE TITANIUM DIOXIDE POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE .494 g/13g 68745-2013_3e8ec8d5-0a76-405c-919c-d8d6e34f4c3a 68745-2013 HUMAN OTC DRUG DOUBLE PERFECTION LUMIERE LONG-WEAR FLAWLESS SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 80 BEIGE TITANIUM DIOXIDE POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE .494 g/13g 68745-2014_3e8ec8d5-0a76-405c-919c-d8d6e34f4c3a 68745-2014 HUMAN OTC DRUG DOUBLE PERFECTION LUMIERE LONG-WEAR FLAWLESS SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 74 AMBRE TITANIUM DIOXIDE POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE .494 g/13g 68745-2015_3e8ec8d5-0a76-405c-919c-d8d6e34f4c3a 68745-2015 HUMAN OTC DRUG DOUBLE PERFECTION LUMIERE LONG-WEAR FLAWLESS SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 114 AMBRE TITANIUM DIOXIDE POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE .494 g/13g 68745-2016_4be5a2b5-06ff-48f1-9c0e-18e7cc005f47 68745-2016 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW SHEER COLOUR, BROAD SPECTRUM SPF 15 SUNSCREEN, No 10 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .84; .96 g/12g; g/12g 68745-2017_4be5a2b5-06ff-48f1-9c0e-18e7cc005f47 68745-2017 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW SHEER COLOUR, BROAD SPECTRUM SPF 15 SUNSCREEN, No 20 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .84; .96 g/12g; g/12g 68745-2018_4be5a2b5-06ff-48f1-9c0e-18e7cc005f47 68745-2018 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW SHEER COLOUR, BROAD SPECTRUM SPF 15 SUNSCREEN, No 30 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .84; .96 g/12g; g/12g 68745-2019_4be5a2b5-06ff-48f1-9c0e-18e7cc005f47 68745-2019 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW SHEER COLOUR, BROAD SPECTRUM SPF 15 SUNSCREEN, No 40 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .84; .96 g/12g; g/12g 68745-2020_4be5a2b5-06ff-48f1-9c0e-18e7cc005f47 68745-2020 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW SHEER COLOUR, BROAD SPECTRUM SPF 15 SUNSCREEN, No 50 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .84; .96 g/12g; g/12g 68745-2021_4be5a2b5-06ff-48f1-9c0e-18e7cc005f47 68745-2021 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW SHEER COLOUR, BROAD SPECTRUM SPF 15 SUNSCREEN, No 60 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .84; .96 g/12g; g/12g 68745-2022_4be5a2b5-06ff-48f1-9c0e-18e7cc005f47 68745-2022 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW SHEER COLOUR, BROAD SPECTRUM SPF 15 SUNSCREEN, No 70 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .84; .96 g/12g; g/12g 68745-2023_5bfc3690-5bca-4384-b567-68865e997356 68745-2023 HUMAN OTC DRUG CC COMPLETE CORRECTION SUNSCREEN BROAD SPECTRUM SPF 30, 20 BEIGE Titanium dioxide CREAM TOPICAL 20130624 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE 120 mg/mL 68745-2024_6472a6b9-7134-4bdb-8158-f4007b6e5c94 68745-2024 HUMAN OTC DRUG LE BLANC LIGHT REVEALING BRIGHTENING MAKEUP BASE BROAD SPECTRUM SPF 30 SUNSCREEN, 10 ROSEE Ensulizole, Octinoxate, and Titanium dioxide EMULSION TOPICAL 20130902 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 27; 30; 92 mg/mL; mg/mL; mg/mL 68745-2025_1015852f-128e-434e-9a9a-dd0b622fc694 68745-2025 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 12 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL 68745-2026_1015852f-128e-434e-9a9a-dd0b622fc694 68745-2026 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 22 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL 68745-2027_1015852f-128e-434e-9a9a-dd0b622fc694 68745-2027 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 10 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL 68745-2028_1015852f-128e-434e-9a9a-dd0b622fc694 68745-2028 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 20 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL 68745-2029_1015852f-128e-434e-9a9a-dd0b622fc694 68745-2029 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 30 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL 68745-2030_1015852f-128e-434e-9a9a-dd0b622fc694 68745-2030 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 40 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL 68745-2031_1015852f-128e-434e-9a9a-dd0b622fc694 68745-2031 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 50 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL 68745-2032_1015852f-128e-434e-9a9a-dd0b622fc694 68745-2032 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 60 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL 68745-2033_1015852f-128e-434e-9a9a-dd0b622fc694 68745-2033 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 70 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL 68745-2034_13d485ee-0a97-46e1-8afe-7f28b2c7fb51 68745-2034 HUMAN OTC DRUG LES BEIGES ALL-IN-ONE HEALTHY GLOW FLUID, BROAD SPECTRUM SPF 15 SUNSCREEN, No 10 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 25; 64 mg/mL; mg/mL 68745-2035_13d485ee-0a97-46e1-8afe-7f28b2c7fb51 68745-2035 HUMAN OTC DRUG LES BEIGES ALL-IN-ONE HEALTHY GLOW FLUID, BROAD SPECTRUM SPF 15 SUNSCREEN, No 20 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 25; 64 mg/mL; mg/mL 68745-2036_13d485ee-0a97-46e1-8afe-7f28b2c7fb51 68745-2036 HUMAN OTC DRUG LES BEIGES ALL-IN-ONE HEALTHY GLOW FLUID, BROAD SPECTRUM SPF 15 SUNSCREEN, No 30 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 25; 64 mg/mL; mg/mL 68745-2037_13d485ee-0a97-46e1-8afe-7f28b2c7fb51 68745-2037 HUMAN OTC DRUG LES BEIGES ALL-IN-ONE HEALTHY GLOW FLUID, BROAD SPECTRUM SPF 15 SUNSCREEN, No 40 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 25; 64 mg/mL; mg/mL 68745-2038_13d485ee-0a97-46e1-8afe-7f28b2c7fb51 68745-2038 HUMAN OTC DRUG LES BEIGES ALL-IN-ONE HEALTHY GLOW FLUID, BROAD SPECTRUM SPF 15 SUNSCREEN, No 50 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 25; 64 mg/mL; mg/mL 68745-2039_13d485ee-0a97-46e1-8afe-7f28b2c7fb51 68745-2039 HUMAN OTC DRUG LES BEIGES ALL-IN-ONE HEALTHY GLOW FLUID, BROAD SPECTRUM SPF 15 SUNSCREEN, No 60 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 25; 64 mg/mL; mg/mL 68745-2040_1f706ede-45cd-45a2-a8e6-7da9df449b4a 68745-2040 HUMAN OTC DRUG CC COMPLETE CORRECTION SUNSCREEN BROAD SPECTRUM SPF 25, 32 BEIGE ROSE Titanium dioxide CREAM TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE TITANIUM DIOXIDE 120 mg/mL 68745-2041_968c7cf3-4d6d-44bd-8f84-2939821d39c9 68745-2041 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW MULTI-COLOUR, BROAD SPECTRUM SPF 15 SUNSCREEN, NO 01 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .77; .88 g/11g; g/11g 68745-2042_968c7cf3-4d6d-44bd-8f84-2939821d39c9 68745-2042 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW MULTI-COLOUR, BROAD SPECTRUM SPF 15 SUNSCREEN, NO 02 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .77; .88 g/11g; g/11g 68745-2043_d3a6b963-ef1d-4219-ac47-9989a14b6339 68745-2043 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 70 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20131104 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL 68747-6027_77714ef0-e991-4294-9566-9117cf851d6d 68747-6027 HUMAN OTC DRUG Freshmint Anticavity Fluoride Gel Toothpaste Fluoride Toothpaste PASTE, DENTIFRICE DENTAL 20090825 OTC MONOGRAPH FINAL part355 Dabur India Limited SODIUM FLUORIDE 2.2 mg/g 68747-6028_7b64f179-d501-48d7-80d6-40485dda052d 68747-6028 HUMAN OTC DRUG Maxixum Security Gel Toothpaste Fluoride Toothpaste PASTE, DENTIFRICE DENTAL 20090825 OTC MONOGRAPH FINAL part355 Dabur India Limited SODIUM FLUORIDE 2.2 mg/g 68747-6029_3161f610-bf6e-45ee-89b4-10f65c908c61 68747-6029 HUMAN OTC DRUG Iodent Fluoride Toothpaste Fluoride Toothpaste PASTE, DENTIFRICE DENTAL 20090825 OTC MONOGRAPH FINAL part355 Dabur India Limited SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 68747-6030_8eea2823-e207-4870-b9f9-25eae9637a7c 68747-6030 HUMAN OTC DRUG Maxixum Security Gel Toothpaste Fluoride Toothpaste PASTE, DENTIFRICE DENTAL 20090825 OTC MONOGRAPH FINAL part355 Dabur India Limited SODIUM FLUORIDE 2.2 mg/g 68747-6031_7bbd3de6-b26b-49bf-80e8-717d6b33ed17 68747-6031 HUMAN OTC DRUG Freshmint Sensitive Toothpaste Fluoride Toothpaste PASTE, DENTIFRICE DENTAL 20090825 OTC MONOGRAPH FINAL part355 Dabur India Limited POTASSIUM NITRATE; SODIUM FLUORIDE 50; 2.4 mg/g; mg/g 68747-6032_0b12c46c-f046-4cb1-a290-4795b196e2ff 68747-6032 HUMAN OTC DRUG Iodent Fluoride Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20120228 OTC MONOGRAPH FINAL part355 Dabur India Limited SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 68747-6033_0595271e-2083-4c54-9201-ec3a7672dad7 68747-6033 HUMAN OTC DRUG Bee Smart SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20120228 OTC MONOGRAPH FINAL part355 Dabur India Limited SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g 68752-005_5846e561-28dd-44fb-8f29-7c7ce2bb8cfb 68752-005 HUMAN OTC DRUG Cetirizine hydrochloride Cetirizine hydrochloride TABLET ORAL 20100625 ANDA ANDA077498 TriMarc Labs CETIRIZINE HYDROCHLORIDE 10 mg/1 68752-012_361b28aa-e306-46e6-9506-ba9a09a24dcf 68752-012 HUMAN OTC DRUG GUAIFENESIN DM GUAIFENESIN DEXTROMETHORPHAN TABLET ORAL 20120417 OTC MONOGRAPH FINAL part341 PD-Rx Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 68752-015_08c0f6c6-d9ba-42fb-8635-dc5d560a9272 68752-015 HUMAN OTC DRUG Lidocaine 5% Lidocaine 5% CREAM TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part348 TriMarc Labs LIDOCAINE 5 g/100g 68752-022_f8b2e1f9-3c39-4f07-bff8-d026c377c08e 68752-022 HUMAN OTC DRUG EC-81Aspirin Enteric Coated Aspirin TABLET ORAL 20100811 OTC MONOGRAPH FINAL part343 TriMarc Labs ASPIRIN 81 mg/1 68752-024_1bed918f-2201-4817-b8e8-307756fb1b27 68752-024 HUMAN OTC DRUG Lidocaine Lidocaine CREAM TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part348 PD-Rx Pharmaceuticals, Inc. LIDOCAINE 4 g/100g 68752-025_35c73fd8-be30-4c29-89e0-dcbe684222b5 68752-025 HUMAN PRESCRIPTION DRUG Nitroglycerin ER Nitroglycerin CAPSULE ORAL 20100510 ANDA ANDA087814 PD-Rx Pharmaceuticals, Inc. NITROGLYCERIN 2.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68752-034_8b08f442-5483-4d46-a981-b89227b597f8 68752-034 HUMAN OTC DRUG BENZOYL PEROXIDE BENZOYL PEROXIDE LOTION TOPICAL 20041116 OTC MONOGRAPH FINAL part333D TriMarc Labs BENZOYL PEROXIDE 50 mg/g 68752-047_4bf8ed7b-1486-42be-8401-ab91ce2e5a95 68752-047 HUMAN OTC DRUG BENZOYL PEROXIDE BENZOYL PEROXIDE LOTION TOPICAL 20041116 OTC MONOGRAPH FINAL part333D TriMarc Labs BENZOYL PEROXIDE 100 mg/g 68752-065_9eeff1ab-09b1-4180-bce0-9198065605e0 68752-065 HUMAN PRESCRIPTION DRUG Nitroglycerin ER Nitroglycerin CAPSULE ORAL 20100510 ANDA ANDA087815 PD-Rx Pharmaceuticals, Inc. NITROGLYCERIN 6.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68752-090_13a6b628-7d82-4b96-8bee-9c9656fec904 68752-090 HUMAN PRESCRIPTION DRUG Nitroglycerin ER Nitroglycerin CAPSULE ORAL 20100510 ANDA ANDA087816 PD-Rx Pharmaceuticals, Inc. NITROGLYCERIN 9 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68752-205_c7564424-fd93-4aba-96ac-617494f9dd7c 68752-205 HUMAN OTC DRUG BENZOYL PEROXIDE BENZOYL PEROXIDE GEL TOPICAL 20041116 OTC MONOGRAPH FINAL part333D TriMarc Labs BENZOYL PEROXIDE 50 mg/g 68752-210_348768a6-a23b-421f-8831-4a63f23be087 68752-210 HUMAN OTC DRUG BENZOYL PEROXIDE BENZOYL PEROXIDE GEL TOPICAL 20041116 OTC MONOGRAPH FINAL part333D TriMarc Labs BENZOYL PEROXIDE 100 mg/g 68754-150_50092344-ecd8-4da4-aa57-3132bbb8c8a8 68754-150 HUMAN OTC DRUG Medicated Anti-Fungal Miconazole Miconazole Nitrate LIQUID TOPICAL 20100602 OTC MONOGRAPH FINAL part333 American Spraytech, LLC MICONAZOLE NITRATE 2 g/100g 68758-009_24a1d522-1d6d-4ec2-a80e-971908135b34 68758-009 HUMAN OTC DRUG EXTEN-10 INSTANT YOUTH BOOSTING MOISTURIZER SPF 15 OCTINOXATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20100415 OTC MONOGRAPH NOT FINAL part352 GOOD SKIN DERMACARE AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 mL/100mL; mL/100mL; mL/100mL 68758-010_25b253bd-6daa-47f1-bdcb-66812d2671a7 68758-010 HUMAN OTC DRUG BB10 INSTANT SKIN PERFECTOR BROAD SPECTRUM SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE LIQUID TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part352 GOOD SKIN DERMACARE OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .08175; .0436; .02725; .01199 g/mL; g/mL; g/mL; g/mL 68759-003_d0b487ac-4e50-45d1-b5ae-844b65e3c8af 68759-003 HUMAN OTC DRUG YOUTH FULL TINTED MOISTURIZER SPF 15 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMERICAN BEAUTY COSMETICS OCTINOXATE; TITANIUM DIOXIDE 7.5; 3 mL/100mL; mL/100mL 68762-107_04f5a95a-2315-407f-9579-ff51c88cd2cf 68762-107 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040201 UNAPPROVED MEDICAL GAS American Home Medical Equipment Co. LLC OXYGEN 99 L/100L 68769-002_ff1e816b-ec2f-45d2-8c9b-e0efa83651ae 68769-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Dealer's Medical Equipment Solutions Inc dba Colorado Compressed Gases, Inc. OXYGEN 99 L/100L 68770-101_f5ab18fa-f612-4a84-afcc-69c65b226a07 68770-101 HUMAN OTC DRUG Womens Dry Eye Pulsatilla, Sepia, Euphrasia, Alumina, Arsenicum album, Nux mosch, Zincum m LIQUID INTRAOCULAR 20040601 UNAPPROVED HOMEOPATHIC Natural Ophthalmics, Inc ALUMINUM OXIDE; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; NUTMEG; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; ZINC 10; 12; 5; 6; 8; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68770-102_9f73d25b-93f4-4081-bc9f-5fc6913def8b 68770-102 HUMAN OTC DRUG Dry Eye Forte Sulphur, Strychnos Nux-Vomica Seed, Euphrasia Stricta, Aluminum Oxide, Arsenic Trioxide, Nutmeg, Zinc LIQUID INTRAOCULAR 20040601 UNAPPROVED HOMEOPATHIC Natural Ophthalmics, Inc ALUMINUM OXIDE; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; NUTMEG; STRYCHNOS NUX-VOMICA SEED; SULFUR; ZINC 10; 12; 5; 6; 12; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68770-120_31a0aa57-48af-41a6-b47e-16ba10cd6fd6 68770-120 HUMAN OTC DRUG Allergy Desensitization Onion, Apis Mellifera, Schoenocaulon Officinale Seed, Euphrasia Stricta LIQUID INTRAOCULAR 20040601 UNAPPROVED HOMEOPATHIC Natural Ophthalmics, Inc APIS MELLIFERA; EUPHRASIA STRICTA; ONION; SCHOENOCAULON OFFICINALE SEED 6; 4; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68770-130_13dd31b5-2390-4faf-9a0f-542a67c006ee 68770-130 HUMAN OTC DRUG Cataract Crystalline Lens Cineraria Maritima, Euphrasia Strictica, Causticum, Calcarea phosphorica, Sepia, Calcarea flourica, Silicea LIQUID INTRAOCULAR 20040601 UNAPPROVED HOMEOPATHIC Natural Ophthalmics, Inc CALCIUM FLUORIDE; CAUSTICUM; EUPHRASIA STRICTA; JACOBAEA MARITIMA; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE 11; 6; 6; 5; 6; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68770-142_34eca2e8-9066-4cff-b9b7-4ebaefdf43d3 68770-142 HUMAN OTC DRUG Ortho-K Thin (Daytime) Aluminum Oxide, Apis mellifera, Arsenic Trioxide, Calendula Officinalis Flowering Top, Tribasic Calcium Phosphate, Euphrasia Stricta, Delphinium Staphisagria Seeds, Sulphur LIQUID INTRAOCULAR 20040601 UNAPPROVED HOMEOPATHIC Natural Ophthalmics, Inc ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; CALENDULA OFFICINALIS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; EUPHRASIA STRICTA; SULFUR; TRIBASIC CALCIUM PHOSPHATE 12; 6; 8; 7; 6; 6; 7; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68770-143_1b374437-92d5-4b9d-a832-3a5ad26bc7bb 68770-143 HUMAN OTC DRUG Ortho-K Thick (Night) Euphrasia Stricta, Aluminum Oxide, Arsenic Trioxide, Apis mellifera, Tribasic Calcium Phosphate, Delphinium Staphisagria Seeds, Sulphur, Calendula Officinalis Flowering Top LIQUID INTRAOCULAR 20040601 UNAPPROVED HOMEOPATHIC Natural Ophthalmics, Inc ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; CALENDULA OFFICINALIS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; EUPHRASIA STRICTA; SULFUR; TRIBASIC CALCIUM PHOSPHATE 12; 6; 8; 7; 6; 6; 7; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 68774-400_af2f181f-66e2-49b4-b9dd-a43054c73274 68774-400 HUMAN PRESCRIPTION DRUG Albuterol Sulfate ER Albuterol Sulfate TABLET, EXTENDED RELEASE ORAL 20020930 ANDA ANDA076130 DAVA Pharmaceuticals, Inc. ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 68774-401_af2f181f-66e2-49b4-b9dd-a43054c73274 68774-401 HUMAN PRESCRIPTION DRUG Albuterol Sulfate ER Albuterol Sulfate TABLET, EXTENDED RELEASE ORAL 20020930 ANDA ANDA076130 DAVA Pharmaceuticals, Inc. ALBUTEROL SULFATE 8 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 68774-600_acb1b240-b030-4f33-a091-dfb1a07981a1 68774-600 HUMAN PRESCRIPTION DRUG VoSpire ER Albuterol Sulfate TABLET, EXTENDED RELEASE ORAL 20020930 ANDA ANDA076130 DAVA Pharmaceuticals, Inc. ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 68774-601_acb1b240-b030-4f33-a091-dfb1a07981a1 68774-601 HUMAN PRESCRIPTION DRUG VoSpire ER Albuterol Sulfate TABLET, EXTENDED RELEASE ORAL 20020930 ANDA ANDA076130 DAVA Pharmaceuticals, Inc. ALBUTEROL SULFATE 8 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 68776-1001_25d2009c-2f79-4de4-9670-2f2b6a29eed1 68776-1001 HUMAN OTC DRUG Wyandotte Sanifect E3 ALCOHOL LOTION TOPICAL 20061001 OTC MONOGRAPH NOT FINAL part333E Alex C. Fergusson, Inc. ALCOHOL 60.1 L/100L 68776-1003_57b676c7-a336-4def-871e-2b3ebb19348a 68776-1003 HUMAN OTC DRUG WYANDOTTE SANIFECT E3-NA BENZALKONIUM CHLORIDE LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Alex C. Fergusson, Inc. BENZALKONIUM CHLORIDE 99468.4 g/100L 68776-1004_6af3eca5-f342-4442-b497-b78d380daa81 68776-1004 HUMAN OTC DRUG WYANDOTTE SANIFECT E2 BENZALKONIUM CHLORIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333A Alex C. Fergusson, Inc. BENZALKONIUM CHLORIDE 268575.42 mg/208198mL 68776-1005_abcebd68-bb93-42bd-826b-7968c14f55f4 68776-1005 HUMAN OTC DRUG WYANDOTTE SANIFECT FOAM-E II CHLOROXYLENOL LIQUID TOPICAL 20090106 OTC MONOGRAPH NOT FINAL part333A Alex C. Fergusson, Inc. CHLOROXYLENOL 2081980 mg/208198mL 68776-1006_8076d92c-76dd-4da7-b3e5-51a0210cca43 68776-1006 HUMAN OTC DRUG AFCO 5512 BENZALKONIUM CHLORIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333A Alex C. Fergusson, Inc. BENZALKONIUM CHLORIDE 1.29 mg/mL 68782-001_a4d5e348-5caf-4840-a7ea-e77d1923fda5 68782-001 HUMAN PRESCRIPTION DRUG Macugen pegaptanib sodium INJECTION, SOLUTION INTRAVITREAL 20041217 NDA NDA021756 Eyetech Inc. PEGAPTANIB SODIUM 3.47 mg/mL Oligonucleotides [Chemical/Ingredient],Aptamers, Nucleotide [Chemical/Ingredient] 68784-101_9fbf7acd-f075-4a82-a47d-d0484055bfc5 68784-101 HUMAN OTC DRUG Hemorrhoidal COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY RECTAL 20140401 OTC MONOGRAPH FINAL part346 Acino Products, LLC. COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 1768.8; 5 mg/1; mg/1 68784-102_80ab9dbd-08db-4aa1-afff-6daf6987b2b7 68784-102 HUMAN OTC DRUG BISACODYL BISACODYL SUPPOSITORY RECTAL 20050101 OTC MONOGRAPH NOT FINAL part334 Acino Products, LLC BISACODYL 10 mg/1 68784-108_7b79a8c2-83a2-46ff-99bc-01b1c61bfd74 68784-108 HUMAN PRESCRIPTION DRUG Rectacort - HC HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 20061101 UNAPPROVED DRUG OTHER Acino Products, LLC. HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68786-120_785db725-1549-4af4-bd79-3eae8658adea 68786-120 HUMAN OTC DRUG alcohol alcohol SWAB TOPICAL 20111219 OTC MONOGRAPH FINAL part344 Sion Biotext Medical Ltd ISOPROPYL ALCOHOL .7 mL/mL 68786-121_950a3dc6-7a57-4341-8d64-7721071a4c24 68786-121 HUMAN OTC DRUG alcohol alcohol SWAB TOPICAL 20120629 OTC MONOGRAPH NOT FINAL part333A Sion Biotext Medical Ltd ISOPROPYL ALCOHOL .7 mL/mL 68786-122_f56a7ef1-3180-46f0-916f-ff354bcbc63d 68786-122 HUMAN OTC DRUG alcohol alcohol SWAB TOPICAL 20140425 OTC MONOGRAPH FINAL part344 Sion Biotext Medical Ltd ISOPROPYL ALCOHOL .7 mL/mL 68786-130_ff0021d3-be67-4e30-b86c-593cc279e122 68786-130 HUMAN OTC DRUG Povidone Iodine POVIDONE-IODINE SWAB TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part333A Sion Biotext Medical Ltd POVIDONE-IODINE .1 g/1 68786-140_95e3d9a2-9981-4dc2-9f21-4859fd2e3eaf 68786-140 HUMAN OTC DRUG Povidone Iodine POVIDONE-IODINE SWAB TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part333A Sion Biotext Medical Ltd POVIDONE-IODINE .1 g/1 68786-160_0a4fa09b-09a8-40f2-a280-1df8d8bc852c 68786-160 HUMAN OTC DRUG Lemon Glycerin SWAB ORAL 20130411 OTC MONOGRAPH NOT FINAL part356 Sion Biotext Medical Ltd GLYCERIN 7.5 1/1 68786-211_b0733a84-dee5-4a0b-a501-aa819d9f17c4 68786-211 HUMAN OTC DRUG PETROLATUM PETROLATUM JELLY TOPICAL 20121204 OTC MONOGRAPH FINAL part347 Sion Biotext Medical Ltd PETROLATUM 1 g/g 68786-212_43831d2a-705c-4715-bfaf-f8f61443ec58 68786-212 HUMAN OTC DRUG Vitamin A D PETROLATUM OINTMENT TOPICAL 20120709 OTC MONOGRAPH FINAL part347 Sion Biotext Medical Ltd. PETROLATUM .75 g/g 68786-216_9986626d-c09a-4bc6-9190-a9c59ba336d8 68786-216 HUMAN OTC DRUG bacitracin zinc, neomycin sulfate and polymyxin b sulfate bacitracin zinc, neomycin sulfate and polymyxin b sulfate OINTMENT TOPICAL 20120709 OTC MONOGRAPH FINAL part333B Sion Biotext Medical Ltd BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [iU]/g; mg/g; [iU]/g 68786-218_79407333-c9ab-4dca-a6df-1b5ade485918 68786-218 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20120709 OTC MONOGRAPH FINAL part333B Sion Biotext Medical Ltd BACITRACIN 500 [iU]/g 68786-220_12837633-fbd1-4a13-bbd7-6cf053c915f4 68786-220 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20120706 OTC MONOGRAPH FINAL part333B Sion Biotext Medical Ltd BACITRACIN ZINC 500 [iU]/g 68786-224_66c7bef8-ba65-41a5-8a51-954b2c4025a1 68786-224 HUMAN OTC DRUG Hydrocortisone Hydrocortisone Acetate CREAM TOPICAL 20120706 OTC MONOGRAPH NOT FINAL part348 Sion Biotext Medical Ltd HYDROCORTISONE ACETATE 1 g/100g 68786-226_c310d58b-765f-46fb-8814-49245c9b5734 68786-226 HUMAN OTC DRUG zinc oxide zinc oxide OINTMENT TOPICAL 20100201 OTC MONOGRAPH FINAL part347 Sion Biotext Medical Ltd ZINC OXIDE 1.8 g/100g 68786-228_f967244a-c42c-4406-99ba-40d2c0135fc4 68786-228 HUMAN OTC DRUG zinc oxide zinc oxide OINTMENT TOPICAL 20100201 OTC MONOGRAPH FINAL part347 Sion Biotext Medical Ltd ZINC OXIDE 1.8 g/100g 68786-232_77de996f-4d00-42bf-9a52-daefa0c732c6 68786-232 HUMAN OTC DRUG Lanolin Lanolin OINTMENT TOPICAL 20120709 OTC MONOGRAPH FINAL part347 Sion Biotext Medical Ltd LANOLIN 50 g/100g 68788-0005_8f6f6c40-f8d7-4c3c-a570-86ec234c6f73 68788-0005 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110209 ANDA ANDA077032 Preferred Pharmaceuticals, Inc CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-0007_22e98bda-195f-4301-b0ea-ae99edf68ed5 68788-0007 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20141017 ANDA ANDA077534 Preferred Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-0012_5bd95efc-8ec5-4600-b145-4a55c7cf2b5a 68788-0012 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20090204 ANDA ANDA077519 Preferred Pharmaceuticals, Inc. BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-0013_5bd95efc-8ec5-4600-b145-4a55c7cf2b5a 68788-0013 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20090204 ANDA ANDA077519 Preferred Pharmaceuticals, Inc. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-0014_7d957735-44cd-44af-bc12-edbb13cc2e3b 68788-0014 HUMAN OTC DRUG Rugby Hemorrhoidal Phenylephrine Hydrochloride and Fat, Hard SUPPOSITORY RECTAL 20131007 OTC MONOGRAPH FINAL part346 Preferred Pharmaceuticals, Inc. FAT, HARD; PHENYLEPHRINE HYDROCHLORIDE 1.86; .00525 g/1; g/1 68788-0039_e19a5fd5-1a79-46ab-abf7-72315637b4b8 68788-0039 HUMAN OTC DRUG Tears Renewed Lubricant DEXTRAN 70 SOLUTION OPHTHALMIC 20101116 OTC MONOGRAPH FINAL part349 Preferred Pharmaceuticals, Inc DEXTRAN 70; HYPROMELLOSES .001; .003 mL/mL; mL/mL 68788-0046_cbe863a8-51f3-4fcb-a365-bedfffe7c832 68788-0046 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19930401 ANDA ANDA073589 Preferred Pharmaceuticals, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 68788-0047_b10cf380-c345-4b60-84be-443d6a2d1eb9 68788-0047 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20110331 ANDA ANDA065191 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 68788-0048_e8f4d01d-73ca-4a04-9682-1f3a7c3a26c6 68788-0048 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20130606 ANDA ANDA090467 Preferred Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68788-0053_a4a75549-b795-47d9-9579-fd3c0fd7a32e 68788-0053 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20130624 ANDA ANDA074253 Preferred Pharmaceuticals, Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 68788-0070_35fcd59e-9d23-468f-9168-a5fc8513a3f9 68788-0070 HUMAN OTC DRUG Clotrimazole CLOTRIMAZOLE CREAM TOPICAL 20130806 OTC MONOGRAPH FINAL part333C Preferred Pharmaceuticals, Inc. CLOTRIMAZOLE 10 mg/g 68788-0074_5fb4a596-7d7a-437a-a4c8-7920886f5521 68788-0074 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130318 ANDA ANDA075828 Preferred Pharmaceuticals, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-0076_2505a038-cfe8-4b40-8da9-edc0c61cd2d2 68788-0076 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 20110301 ANDA ANDA040119 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 68788-0118_dec9c5f6-929e-493d-ac4f-c24cf1f9e6ef 68788-0118 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20121213 OTC MONOGRAPH FINAL part336 Preferred Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 68788-0134_f54e6b32-4a34-4cfe-8351-68e3eb8d9bb6 68788-0134 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19970917 ANDA ANDA074880 Preferred Pharmaceuticals, Inc ALBUTEROL SULFATE .83 mg/mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 68788-0139_cb4cf79b-3521-4727-ae32-e61bc3786300 68788-0139 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20140521 NDA NDA019117 Preferred Pharmaceuticals, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-0141_d6f0ae55-e620-4590-9e3e-a8e93677c210 68788-0141 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20130218 ANDA ANDA075795 Preferred Pharmaceuticals, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68788-0142_d6f0ae55-e620-4590-9e3e-a8e93677c210 68788-0142 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20130218 ANDA ANDA075795 Preferred Pharmaceuticals, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68788-0149_cca0ec29-4b48-4d2d-9117-2f60400ffab8 68788-0149 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20140820 ANDA ANDA086413 Preferred Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 5 mg/g 68788-0167_5bd6a89c-b140-4c78-ba36-46450ed5cfc1 68788-0167 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130319 ANDA ANDA077127 Preferred Pharmaceuticals, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68788-0169_d3a3b759-ad13-4936-b63a-b4bc140264d3 68788-0169 HUMAN OTC DRUG Clotrimazole clotrimazole CREAM VAGINAL 20130806 ANDA ANDA074165 Preferred Pharmaceuticals, Inc. CLOTRIMAZOLE 1 g/100g 68788-0173_55038df8-077c-416c-ba5e-aa7fad9f390b 68788-0173 HUMAN OTC DRUG DocQLace docusate sodium CAPSULE ORAL 20141112 OTC MONOGRAPH NOT FINAL part334 Preferred Pharmaceuticals, Inc. DOCUSATE SODIUM 100 mg/1 68788-0177_bdc73a7d-27c9-47d2-8c44-467451a65aea 68788-0177 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 19891205 ANDA ANDA072637 Preferred Pharmaceuticals, Inc. ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 68788-0178_a6b33844-2be4-417e-90b9-e5e3914741a2 68788-0178 HUMAN PRESCRIPTION DRUG Nystatin nystatin CREAM TOPICAL 20140113 ANDA ANDA065315 Preferred Pharmaceuticals, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 68788-0179_f509237c-77d9-4d8e-87b5-0ff1831e8c70 68788-0179 HUMAN OTC DRUG FERROUS SULFATE IRON SUPPLEMENT TABLET ORAL 20040618 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc. FERROUS SULFATE 325 mg/1 68788-0186_b7209391-86c9-4f9c-867e-24d559101b94 68788-0186 HUMAN OTC DRUG aspirin aspirin TABLET, COATED ORAL 20100628 OTC MONOGRAPH FINAL part343 Preferred Pharmaceuticals, Inc ASPIRIN 81 mg/1 68788-0190_5e641313-bf08-40b4-a292-0ccdceb5b0b4 68788-0190 HUMAN OTC DRUG Pink Bismuth Bismuth Subsalicylate TABLET, CHEWABLE ORAL 20101201 OTC MONOGRAPH FINAL part335 Preferred Pharmaceuticals, Inc BISMUTH SUBSALICYLATE 262 mg/1 68788-0225_57f21b4e-a012-4c93-9468-dfb622f15d02 68788-0225 HUMAN OTC DRUG Earwax Removal Aid CARBAMIDE PEROXIDE LIQUID AURICULAR (OTIC) 20110523 OTC MONOGRAPH FINAL part344 Preferred Pharmaceuticals, Inc. CARBAMIDE PEROXIDE 65 mg/mL 68788-0241_47baa471-b3b5-431b-a2e5-e302c4c7a8f8 68788-0241 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20130827 ANDA ANDA072927 Preferred Pharmaceuticals, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-0253_ac3d3aa4-c029-468f-a49c-e6a93fc92111 68788-0253 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA076649 Preferred Pharmaceuticals, Inc CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68788-0254_cb8b6e75-6865-4f77-924c-147774e15e31 68788-0254 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA076649 Preferred Pharmaceuticals, Inc CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68788-0255_bdc73a7d-27c9-47d2-8c44-467451a65aea 68788-0255 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 19891205 ANDA ANDA072637 Preferred Pharmaceuticals, Inc. ALBUTEROL SULFATE 2 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 68788-0285_ba198676-f065-4798-bbec-5f0e9d59c2e0 68788-0285 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20110317 ANDA ANDA088628 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 68788-0320_a8da6642-94c4-495a-86d6-8c073b73f33c 68788-0320 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20110308 ANDA ANDA075536 Preferred Pharmaceuticals, Inc DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68788-0332_a6263943-bd35-4964-9db0-992553c3fa8e 68788-0332 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate OINTMENT TOPICAL 20130419 ANDA ANDA074221 Preferred Pharmaceuticals, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-0344_3d834359-b870-45ff-8d64-006e1cbc2c92 68788-0344 HUMAN OTC DRUG Miconazole Nitrate miconazole nitrate CREAM TOPICAL 20140902 OTC MONOGRAPH FINAL part333C Preferred Pharmaceuticals, Inc. MICONAZOLE NITRATE 20 mg/g 68788-0353_2b1a9b82-4637-4dc9-83c5-ac34cb14372f 68788-0353 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SOLUTION ORAL 20130923 ANDA ANDA040891 Preferred Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68788-0384_0d2aa12b-bab0-472c-9e69-d3eee29e3be4 68788-0384 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 20130314 ANDA ANDA040101 Preferred Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68788-0397_2fb16dcb-df51-451c-9194-39eceaafab7b 68788-0397 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Preferred Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68788-0408_d3d33307-05c1-4573-9804-93087189ae80 68788-0408 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 20120127 ANDA ANDA071108 Preferred Pharmaceuticals, Inc FLURAZEPAM HYDROCHLORIDE 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-0426_f9403333-32b2-476e-b124-40d5645b10aa 68788-0426 HUMAN OTC DRUG acetaminophen for children Acetaminophen SUPPOSITORY RECTAL 20101028 ANDA ANDA070607 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN 120 mg/1 68788-0430_bf492f66-080c-42ae-af1b-e14a26b3dde5 68788-0430 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20130401 ANDA ANDA070184 Preferred Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 68788-0435_2fb16dcb-df51-451c-9194-39eceaafab7b 68788-0435 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Preferred Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68788-0446_0ee246f1-fc85-453c-83a7-211752a85ec0 68788-0446 HUMAN PRESCRIPTION DRUG AK-Con Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20050324 ANDA ANDA083590 Preferred Pharmaceuticals, Inc. NAPHAZOLINE HYDROCHLORIDE 1 mg/mL 68788-0453_8e2de7dc-72bc-44cc-97bf-efe776331a2d 68788-0453 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20140820 ANDA ANDA089808 Preferred Pharmaceuticals, Inc. THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 68788-0474_2fb16dcb-df51-451c-9194-39eceaafab7b 68788-0474 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Preferred Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68788-0483_c9d0b574-7d47-41e7-8a16-973dfeb136a7 68788-0483 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111107 ANDA ANDA201091 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 68788-0504_8f406d3b-d87c-43c7-989e-e7b89c48614d 68788-0504 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19990305 ANDA ANDA075382 Preferred Pharmaceuticals, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68788-0505_8f406d3b-d87c-43c7-989e-e7b89c48614d 68788-0505 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19990305 ANDA ANDA075382 Preferred Pharmaceuticals, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68788-0511_e79c9247-0e11-425c-9301-c63a2364a370 68788-0511 HUMAN PRESCRIPTION DRUG Proctosol-HC Hydrocortisone CREAM TOPICAL 20141119 ANDA ANDA088799 Preferred Pharmaceuticals, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-0518_bfba5de0-7abb-4b88-9715-088224b219f0 68788-0518 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20140213 NDA NDA020064 Preferred Pharmaceuticals, Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] 68788-0522_250c440d-9148-4fdf-81af-48544b20e3c0 68788-0522 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20040701 ANDA ANDA072824 Preferred Pharmaceuticals, Inc BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 68788-0523_361b5973-e138-49b5-b52a-54d73e0f9cca 68788-0523 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20040721 ANDA ANDA086183 Preferred Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 68788-0547_d41e43e6-cb50-443f-800f-5c80a51798c8 68788-0547 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20130222 ANDA ANDA075562 Preferred Pharmaceuticals, Inc IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 68788-0561_f6f3e978-dd1d-4d5c-bf7d-1fbc9fe05d0b 68788-0561 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060927 ANDA ANDA077912 Preferred Pharmaceuticals, Inc HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68788-0575_d8f2d888-f5b8-4acb-afb0-342addfa38c5 68788-0575 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19991229 ANDA ANDA074112 Preferred Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-0597_7ca0e960-8ec1-4715-b961-7d7e5d0bd9fa 68788-0597 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate CREAM TOPICAL 20141126 ANDA ANDA070050 Preferred Pharmaceuticals, Inc. BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-0598_b10cf380-c345-4b60-84be-443d6a2d1eb9 68788-0598 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20110331 ANDA ANDA065191 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 68788-0600_1e2350d2-4579-4c21-b219-f574a28ccd7e 68788-0600 HUMAN PRESCRIPTION DRUG Thermazene Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 20130904 NDA NDA018810 Preferred Pharmaceuticals, Inc. SILVER SULFADIAZINE 10 mg/g 68788-0603_3e72d0c6-4374-4dde-bbee-92507f54bc2d 68788-0603 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET, COATED ORAL 20091001 ANDA ANDA071587 Preferred Pharmaceuticals, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 68788-0616_4acf4763-b978-4ca5-8e2d-e6f153bb4025 68788-0616 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20130919 ANDA ANDA065442 Preferred Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 68788-0617_f11b01ea-5be5-49af-afda-4a648edba228 68788-0617 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxaxin SOLUTION/ DROPS AURICULAR (OTIC) 20130322 ANDA ANDA076616 Preferred Pharmaceuticals, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68788-0625_abb61929-9939-425c-96b4-13da1c76fddd 68788-0625 HUMAN PRESCRIPTION DRUG VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20130926 ANDA ANDA090529 Preferred Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68788-0633_f6e5d260-d7c3-48d4-96fc-8998690f5f85 68788-0633 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 20130314 ANDA ANDA064048 Preferred Pharmaceuticals, Inc. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 68788-0645_f01242d2-ae87-46a5-816a-77feec744023 68788-0645 HUMAN OTC DRUG hydrocortisone hydrocortisone OINTMENT TOPICAL 20140123 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc. HYDROCORTISONE 1 g/100g 68788-0681_665bf04b-9732-4e24-944b-6599ba2730de 68788-0681 HUMAN PRESCRIPTION DRUG METHIMAZOLE METHIMAZOLE TABLET ORAL 20140227 ANDA ANDA202068 Preferred Pharmaceuticals, Inc. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] 68788-0686_bc1323b9-d8b4-4c11-a517-118774d1b381 68788-0686 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 20140212 NDA NDA012546 Preferred Pharmaceuticals, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 68788-0708_72ce2984-4d47-4764-8a92-190a72b9efe4 68788-0708 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20141020 ANDA ANDA065392 Preferred Pharmaceuticals, Inc. CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68788-0713_68a18412-49b7-491d-8a62-29c52f0fa6a9 68788-0713 HUMAN PRESCRIPTION DRUG azithromycin AZITHROMYCIN POWDER, FOR SUSPENSION ORAL 19990212 NDA NDA050693 Preferred Pharmaceuticals, Inc. AZITHROMYCIN DIHYDRATE 1 g/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68788-0715_f1d500d6-fbe8-4454-b365-53d5ef591795 68788-0715 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir SUSPENSION ORAL 20110318 ANDA ANDA077026 Preferred Pharmaceuticals, Inc ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68788-0736_99db9629-5678-4471-8555-332064f4d3d4 68788-0736 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20140428 ANDA ANDA040074 Preferred Pharmaceuticals, Inc. PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] 68788-0748_a0972291-45a1-4aea-9470-b0f0ac81cbe3 68788-0748 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20110609 ANDA ANDA040218 Preferred Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 68788-0758_990ebac2-e65d-409f-b979-36f52b13e26e 68788-0758 HUMAN OTC DRUG PHAZYME Simethicone CAPSULE, GELATIN COATED ORAL 20140203 OTC MONOGRAPH FINAL part332 Preferred Pharmaceuticals, Inc. DIMETHICONE 410 180 mg/1 68788-0763_3d185629-4e6b-4276-8d6d-45a09578e89c 68788-0763 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20110518 ANDA ANDA065255 Preferred Pharmaceuticals, Inc AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 68788-0768_e082d783-793f-4c17-b124-04fe377fb272 68788-0768 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 20140820 NDA NDA020998 Preferred Pharmaceuticals, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-0790_4d8de895-99b6-403a-b5f3-35170fa105a2 68788-0790 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Preferred Pharmaceuticals, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 68788-0797_7d1b0cdd-4111-4859-99cc-1aab30bfb081 68788-0797 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Preferred Pharmaceuticals, Inc PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-0802_212a7dc4-1bcf-43b3-8515-4c509b2bb6e3 68788-0802 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20130326 ANDA ANDA078216 Preferred Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-0816_d98c5a63-e5c9-44d4-9359-fbef7a3a94fb 68788-0816 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20101007 ANDA ANDA078938 Preferred Pharmaceuticals, Inc TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68788-0825_1b664106-570f-447e-8a3d-106f4a161a45 68788-0825 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP ORAL 20110603 ANDA ANDA074749 Preferred Pharmaceuticals, inc ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 68788-0839_4104aad8-ded6-4e46-a5c1-4b7120180941 68788-0839 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan HBr and Guiafenesin TABLET, FILM COATED ORAL 20090212 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 68788-0842_9d529239-be05-4022-8864-43b07b2e02c2 68788-0842 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride cetirizine hydrochloride SYRUP ORAL 20101220 ANDA ANDA078496 Preferred Pharmaceuticals, Inc CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 68788-0843_f6f3e978-dd1d-4d5c-bf7d-1fbc9fe05d0b 68788-0843 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060927 ANDA ANDA077912 Preferred Pharmaceuticals, Inc HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68788-0852_6c130ae2-6aca-4264-95e3-dc820abb311c 68788-0852 HUMAN OTC DRUG Q-Tapp DM Elixir Brompheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide ELIXIR ORAL 20010405 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 5; 15 mg/5mL; mg/5mL; mg/5mL 68788-0881_b22d36c8-d346-4853-a73e-fb653231ed3a 68788-0881 HUMAN PRESCRIPTION DRUG Skelaxin Metaxalone TABLET ORAL 20030130 NDA NDA013217 Preferred Pharmaceuticals, Inc METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68788-0920_65c195b1-db3e-4e8f-9d97-fa88d615c6dd 68788-0920 HUMAN PRESCRIPTION DRUG Tetracaine Hydrochloride Tetracaine Hydrochloride SOLUTION OPHTHALMIC 20130516 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc. TETRACAINE HYDROCHLORIDE 5 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] 68788-0926_5fb4a596-7d7a-437a-a4c8-7920886f5521 68788-0926 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130318 ANDA ANDA075828 Preferred Pharmaceuticals, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-0972_333f374f-e0f9-4ac7-8f03-ae1fcc86d79c 68788-0972 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate OINTMENT TOPICAL 19870203 ANDA ANDA071012 Preferred Pharmaceuticals, Inc BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-0985_60d634f5-8da5-4af8-aeaa-4451b4812a30 68788-0985 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 68788-0999_cadeb5b8-985a-452a-ad2e-bffaaea94ca9 68788-0999 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA076649 Preferred Pharmaceuticals, Inc CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68788-1473_e08ba5ea-edb7-439a-8dda-4e1288cc4161 68788-1473 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130619 ANDA ANDA085162 Preferred Pharmaceuticals, Inc. PREDNISONE 10 mg/1 68788-1554_8752e76c-1220-48b2-b394-7536245707e1 68788-1554 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20131118 ANDA ANDA075576 Preferred Pharmaceuticals, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68788-1701_cd7f1d6f-b735-454b-ab37-cd9fa83ad0c6 68788-1701 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20130315 ANDA ANDA077927 Preferred Pharmaceuticals, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-1737_4d11a254-8128-4df0-95f4-fa9e79af60da 68788-1737 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Preferred Pharmaceuticals, Inc AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68788-1738_4d11a254-8128-4df0-95f4-fa9e79af60da 68788-1738 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Preferred Pharmaceuticals, Inc AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68788-1966_ed3a1863-a8ef-4325-bf30-b8fd8e9a4ba7 68788-1966 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20130320 NDA NDA018823 Preferred Pharmaceuticals, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 68788-2027_d8f2d888-f5b8-4acb-afb0-342addfa38c5 68788-2027 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19991229 ANDA ANDA074112 Preferred Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-2029_d8f2d888-f5b8-4acb-afb0-342addfa38c5 68788-2029 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19991229 ANDA ANDA074112 Preferred Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-2112_d0035a8f-2d8f-4b03-91e2-4f613b418cd6 68788-2112 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20131217 ANDA ANDA062269 Preferred Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 68788-2115_3e72d0c6-4374-4dde-bbee-92507f54bc2d 68788-2115 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET, COATED ORAL 20091001 ANDA ANDA071586 Preferred Pharmaceuticals, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 68788-2212_a0972291-45a1-4aea-9470-b0f0ac81cbe3 68788-2212 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20110609 ANDA ANDA040218 Preferred Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 68788-2213_a0972291-45a1-4aea-9470-b0f0ac81cbe3 68788-2213 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20110609 ANDA ANDA040218 Preferred Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 68788-2518_81b5dfb2-5a4a-4b4a-8329-9d48f8a0064d 68788-2518 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140113 ANDA ANDA077253 Preferred Pharmaceuticals, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68788-2582_8cec0a99-5357-484f-bb3a-5d56e342ec9d 68788-2582 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20110615 ANDA ANDA040245 Preferred Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 68788-2634_5fb4a596-7d7a-437a-a4c8-7920886f5521 68788-2634 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130318 ANDA ANDA075828 Preferred Pharmaceuticals, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-4593_ebe4f4a5-3fec-4f30-8289-25e594162c49 68788-4593 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 20130903 ANDA ANDA040189 Preferred Pharmaceuticals, Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-5665_a339af11-bf0a-4fe1-9bd5-5d57e273fcd5 68788-5665 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20120329 ANDA ANDA075022 Preferred Pharmaceuticals, Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 68788-5928_84c72316-dca6-4811-b623-8022dbc6f41f 68788-5928 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20140115 ANDA ANDA087022 Preferred Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 68788-6755_b46a5734-ff83-49ab-86f6-ee86aefbbabc 68788-6755 HUMAN OTC DRUG MEDROX MENTHOL, CAPSAICIN PATCH TOPICAL 20120727 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc. CAPSAICIN; MENTHOL .0375; 5 g/100g; g/100g 68788-6757_8834bbd7-c7ae-41e0-9d54-0178f76886ae 68788-6757 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 20120724 NDA NDA019614 Preferred Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68788-6759_9f887922-1781-4d46-bd83-a153883cf491 68788-6759 HUMAN OTC DRUG Diabetic Siltussin DAS-Na Guaifenesin LIQUID ORAL 20120724 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals Inc. GUAIFENESIN 100 mg/5mL 68788-6760_9c7ab0c9-169f-47e8-9e35-5a6b74121bf7 68788-6760 HUMAN OTC DRUG Diabetic Siltussin DM DAS-Na Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 20120724 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 68788-6761_299c10c0-f54c-40f0-b84c-8b9a70cae004 68788-6761 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20120726 ANDA ANDA078955 Preferred Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68788-6762_299c10c0-f54c-40f0-b84c-8b9a70cae004 68788-6762 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20120726 ANDA ANDA078955 Preferred Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68788-6763_1ed2a01c-6521-451e-819f-7464562314a3 68788-6763 HUMAN PRESCRIPTION DRUG Promethazine VC Promethazinehydrochloride and phenylephrine hydrochloride SYRUP ORAL 20120725 ANDA ANDA040654 Preferred Pharmaceuticals, Inc. PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 5; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 68788-6766_15453da2-c60b-42ca-a997-8ec7bc7dcade 68788-6766 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine Maleate TABLET ORAL 20120726 ANDA ANDA040268 Preferred Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68788-6767_1f4f3819-b4d6-4e52-b50e-cfc315f2e831 68788-6767 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120725 ANDA ANDA200272 Preferred Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 68788-7365_5b9e2fb2-47bb-4a6e-a728-e36a291e1540 68788-7365 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20110321 ANDA ANDA076958 Preferred Pharmaceuticals, Inc LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68788-8001_20030c53-ad1d-41bf-bf24-4c27959cc9fd 68788-8001 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110331 ANDA ANDA074984 Preferred Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68788-8033_e0e25674-a9a8-4ad8-98b7-fcadce79d6be 68788-8033 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20130422 ANDA ANDA017340 Preferred Pharmaceuticals, Inc. TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 68788-8999_c7d02978-a24a-4322-ac5c-0bc9525fc40d 68788-8999 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130604 ANDA ANDA202176 Preferred Pharmaceuticals, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68788-9001_10263c3a-3a35-4f3d-9291-3b465410468e 68788-9001 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100316 ANDA ANDA078561 Preferred Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9002_10263c3a-3a35-4f3d-9291-3b465410468e 68788-9002 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100316 ANDA ANDA078561 Preferred Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9003_10263c3a-3a35-4f3d-9291-3b465410468e 68788-9003 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100316 ANDA ANDA078561 Preferred Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9004_fc8a8367-d2e2-43ba-a3d6-12436e50a183 68788-9004 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20110608 ANDA ANDA076847 Preferred Pharmaceuticals, Inc SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68788-9005_fc8a8367-d2e2-43ba-a3d6-12436e50a183 68788-9005 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20110608 ANDA ANDA076847 Preferred Pharmaceuticals, Inc SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68788-9006_defcab81-92f8-4e70-a21b-e7ad879569de 68788-9006 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20110614 ANDA ANDA075593 Preferred Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68788-9009_a0972291-45a1-4aea-9470-b0f0ac81cbe3 68788-9009 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20110609 ANDA ANDA040218 Preferred Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 68788-9012_6d98efb5-ef6f-487f-ae80-19fea82c2e26 68788-9012 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20110610 ANDA ANDA076639 Preferred Pharmaceuticals, Inc CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68788-9013_e0b4dc05-ab1f-419b-9587-7333386a8622 68788-9013 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 Preferred Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 68788-9014_e0b4dc05-ab1f-419b-9587-7333386a8622 68788-9014 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 Preferred Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 68788-9015_e0b4dc05-ab1f-419b-9587-7333386a8622 68788-9015 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 Preferred Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 68788-9016_e0b4dc05-ab1f-419b-9587-7333386a8622 68788-9016 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085967 Preferred Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] 68788-9017_c24d270d-8c0e-4896-9ee9-de1de02cc671 68788-9017 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20110615 ANDA ANDA065322 Preferred Pharmaceuticals, Inc. AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 68788-9018_c24d270d-8c0e-4896-9ee9-de1de02cc671 68788-9018 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20110615 ANDA ANDA065325 Preferred Pharmaceuticals, Inc. AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 68788-9019_c24d270d-8c0e-4896-9ee9-de1de02cc671 68788-9019 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20110615 ANDA ANDA065322 Preferred Pharmaceuticals, Inc. AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 68788-9020_610575e2-e0f6-4830-9cd3-fcc073d4bd83 68788-9020 HUMAN PRESCRIPTION DRUG ANTIPYRINE AND BENZOCAINE ANTIPYRINE AND BENZOCAINE SOLUTION AURICULAR (OTIC) 20090430 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc. ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 68788-9021_57d4e53a-d3d6-4f40-8e9b-04b34bd49156 68788-9021 HUMAN PRESCRIPTION DRUG SULFASALAZINE SULFASALAZINE TABLET ORAL 20100609 ANDA ANDA087197 Preferred Pharmaceuticals, Inc SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] 68788-9022_c469dded-01b1-46ed-bd20-e5a4eca7a938 68788-9022 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Preferred Pharmaceuticals, Inc NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9023_49549e3f-1e05-4202-ab7c-88cb93d308ca 68788-9023 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Preferred Pharmaceuticals, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68788-9024_defcab81-92f8-4e70-a21b-e7ad879569de 68788-9024 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Preferred Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68788-9025_2bce8717-5beb-4609-9bed-80c33d11e964 68788-9025 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 19950612 ANDA ANDA089718 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 68788-9026_c7400845-fb6b-4338-a6a1-55330bcd021e 68788-9026 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Preferred Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68788-9027_c7400845-fb6b-4338-a6a1-55330bcd021e 68788-9027 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Preferred Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68788-9032_79a045fa-0554-4b67-a671-c732e11b3bf2 68788-9032 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20100101 ANDA ANDA065291 Preferred Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 68788-9033_79a045fa-0554-4b67-a671-c732e11b3bf2 68788-9033 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20100101 ANDA ANDA065291 Preferred Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 68788-9035_bcb7d4f0-33a8-4583-a54c-bb371d985289 68788-9035 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20110725 ANDA ANDA065334 Preferred Pharmaceuticals, Inc AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 68788-9037_ef84272d-6014-4aed-9bb3-c8c09e1c919b 68788-9037 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20110609 ANDA ANDA062396 Preferred Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 68788-9038_e8d81096-c1d1-4027-a044-b7f2c0d3c80b 68788-9038 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 19960718 NDA AUTHORIZED GENERIC NDA050711 Preferred Pharmaceuticals, Inc. AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68788-9041_08ec739b-77c2-492d-bce4-f5178455c657 68788-9041 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Preferred Pharmaceuticals, Inc ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 68788-9042_7b791688-d32a-429c-886e-ffbe57ac0733 68788-9042 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Preferred Pharmaceuticals, Inc ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] 68788-9043_3f5f1132-0819-4c49-bcbf-6190cee07470 68788-9043 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20110125 ANDA ANDA065096 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 68788-9045_fbd94cc6-cf60-4c10-9924-a85dd68bf2a6 68788-9045 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin Monohydrate POWDER, FOR SUSPENSION ORAL 20110310 ANDA ANDA065419 Preferred Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68788-9046_fbd94cc6-cf60-4c10-9924-a85dd68bf2a6 68788-9046 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin Monohydrate POWDER, FOR SUSPENSION ORAL 20110310 ANDA ANDA065419 Preferred Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68788-9047_a740e308-a005-43bf-9667-7b1a29f7e8ea 68788-9047 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Preferred Pharmaceuticals, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68788-9048_a740e308-a005-43bf-9667-7b1a29f7e8ea 68788-9048 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Preferred Pharmaceuticals, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68788-9049_a740e308-a005-43bf-9667-7b1a29f7e8ea 68788-9049 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Preferred Pharmaceuticals, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68788-9050_989900de-360f-4a72-9a2a-35345dbebd54 68788-9050 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Preferred Pharmaceuticals, Inc BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68788-9051_989900de-360f-4a72-9a2a-35345dbebd54 68788-9051 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Preferred Pharmaceuticals, Inc BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68788-9052_989900de-360f-4a72-9a2a-35345dbebd54 68788-9052 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Preferred Pharmaceuticals, Inc BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68788-9053_989900de-360f-4a72-9a2a-35345dbebd54 68788-9053 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Preferred Pharmaceuticals, Inc BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68788-9054_43cd0f65-c2ff-4f32-bd85-7966fd9bbd2a 68788-9054 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE CAPSULE ORAL 20080407 ANDA ANDA040587 Preferred Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 68788-9055_3f5f1132-0819-4c49-bcbf-6190cee07470 68788-9055 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120125 ANDA ANDA065101 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 68788-9056_97487323-0c0d-4dd9-aa7b-39bfe201effa 68788-9056 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110629 ANDA ANDA077455 Preferred Pharmaceuticals, Inc BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68788-9064_351bdcf3-3491-4a55-a27e-50fad226b49b 68788-9064 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20110706 ANDA ANDA074151 Preferred Pharmaceuticals, Inc CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68788-9066_d9887a0d-29d5-483d-94fe-ce99e3a4a8b9 68788-9066 HUMAN OTC DRUG Cheratussin AC codeine phosphate and guaifenesin LIQUID ORAL 19960901 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 68788-9067_54c7dce2-7ec4-4b07-bf60-1bc910381c3d 68788-9067 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20110705 ANDA ANDA076925 Preferred Pharmaceuticals, Inc IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9069_c2692865-e2e6-4497-aeeb-8eb75b620edf 68788-9069 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20110707 ANDA ANDA077797 Preferred Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68788-9070_e731a479-1e8c-4e9d-afd3-614c74d74162 68788-9070 HUMAN OTC DRUG PHAZYME simethicone CAPSULE, GELATIN COATED ORAL 20110504 20150930 OTC MONOGRAPH FINAL part332 Preferred Pharmaceuticals, Inc. DIMETHICONE 410 180 mg/1 68788-9072_fdc76ebd-959d-4185-8906-81755f089fbd 68788-9072 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20050628 ANDA ANDA065148 Preferred Pharmaceuticals, Inc NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 68788-9074_7d1b0cdd-4111-4859-99cc-1aab30bfb081 68788-9074 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Preferred Pharmaceuticals, Inc PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9075_9c7254f4-4129-4dab-aaba-8394cc3e3ec4 68788-9075 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20100806 ANDA ANDA040489 Preferred Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68788-9076_9c7254f4-4129-4dab-aaba-8394cc3e3ec4 68788-9076 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20100806 ANDA ANDA040489 Preferred Pharmaceuticals, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68788-9077_98c45385-6138-44d6-92ae-c744540369cd 68788-9077 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 Preferred Pharmaceuticals, Inc AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68788-9078_98c45385-6138-44d6-92ae-c744540369cd 68788-9078 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065405 Preferred Pharmaceuticals, Inc AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68788-9079_c6a3322d-943c-4f7a-9975-94d3fa38b12c 68788-9079 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20110128 ANDA ANDA073192 Preferred Pharmaceuticals, Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 68788-9080_1cab271a-1c2e-4cd3-8447-e290964413ff 68788-9080 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 Preferred Pharmaceuticals, Inc LORATADINE 10 mg/1 68788-9081_36231ec1-97c0-4931-a689-ac74268a6bb7 68788-9081 HUMAN OTC DRUG Q-Tussin Guaifenesin SOLUTION ORAL 19971001 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc GUAIFENESIN 100 mg/5mL 68788-9082_704dacd4-ecb9-45d7-bf07-b726054c3610 68788-9082 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070027 Preferred Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 68788-9083_704dacd4-ecb9-45d7-bf07-b726054c3610 68788-9083 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070033 Preferred Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 68788-9085_33c2bcaf-65c9-4401-8056-3cf45fb2b906 68788-9085 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Preferred Pharmaceuticals, Inc MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 68788-9086_62e18e8f-676c-4ae7-82c4-20e534f35694 68788-9086 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20070125 ANDA ANDA078060 Preferred Pharmaceuticals, Inc SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 68788-9087_f29d91c8-332c-4069-ac66-3834c1ee2172 68788-9087 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20051005 ANDA ANDA065136 Preferred Pharmaceuticals, Inc CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68788-9088_dc21a4f9-d8f3-4804-ba3e-a26cae143f26 68788-9088 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 20110118 ANDA ANDA073517 Preferred Pharmaceuticals, Inc KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9089_43a04d8f-9dc1-4760-98fc-8f976ddc8a4b 68788-9089 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET ORAL 20050303 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68788-9091_119bd962-30d2-49a6-8aee-238f82527cb0 68788-9091 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Preferred Pharmaceuticals, Inc TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68788-9092_119bd962-30d2-49a6-8aee-238f82527cb0 68788-9092 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Preferred Pharmaceuticals, Inc TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68788-9093_db3cc1b1-ab22-44e6-846c-ce1231f4daf7 68788-9093 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20090313 ANDA ANDA078807 Preferred Pharmaceuticals, Inc METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 68788-9094_5831d093-9a92-43c2-a384-1ba1537dbcf7 68788-9094 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20110629 ANDA ANDA077919 Preferred Pharmaceuticals, Inc TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 68788-9095_7169248d-ee02-45bd-b689-14bcbb078df6 68788-9095 HUMAN OTC DRUG Qdryl Allergy Diphenhydramine Hydrochloride SOLUTION ORAL 19971201 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 68788-9096_cbd19d91-68c9-42d9-bb17-60c7d85448a5 68788-9096 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 20030227 ANDA ANDA040401 Preferred Pharmaceuticals, Inc PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9097_43dd6bbb-89ee-4a0d-bb62-ebd7e70c3d9b 68788-9097 HUMAN PRESCRIPTION DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL 20060214 ANDA ANDA040649 Preferred Pharmaceuticals, Inc DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68788-9098_264abf3d-c466-4209-b911-29ce18b0b816 68788-9098 HUMAN OTC DRUG Siltussin SA Guaifenesin LIQUID ORAL 19981005 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc GUAIFENESIN 100 mg/5mL 68788-9100_b00b296d-6c34-48c8-9cfb-71ccc5c9a908 68788-9100 HUMAN PRESCRIPTION DRUG Promethazine VC Promethazinehydrochloride and phenylephrine hydrochloride SYRUP ORAL 20061207 ANDA ANDA040654 Preferred Pharmaceuticals, Inc PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 5; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 68788-9101_7e2ca78a-5479-48e3-9497-8884d24236e7 68788-9101 HUMAN OTC DRUG Q Tussin DM Dextromethorphan HBr and Guaifenesin SYRUP ORAL 19950401 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 68788-9102_1cb7d58e-0499-483e-8af6-4280f071c750 68788-9102 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 20040806 ANDA ANDA074650 Preferred Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 68788-9103_9dc928f7-d07e-4b1e-ae12-18a2fbd3226b 68788-9103 HUMAN OTC DRUG Siltussin DM Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 19920905 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 68788-9107_bd041ef5-6bbd-4d94-b532-fecdb320668e 68788-9107 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20100730 ANDA ANDA018851 Preferred Pharmaceuticals, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9108_bd041ef5-6bbd-4d94-b532-fecdb320668e 68788-9108 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20100730 ANDA ANDA018851 Preferred Pharmaceuticals, Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9109_da685bb0-9b81-4df6-9e71-92f7dbfb4a42 68788-9109 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20110824 ANDA ANDA074916 Preferred Pharmaceuticals, Inc IBUPROFEN 100 mg/5mL 68788-9110_3ec152d2-fe90-4a16-a53b-1d814aad91a8 68788-9110 HUMAN PRESCRIPTION DRUG IBUPROFEN Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Preferred Pharmaceuticals, Inc IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9111_3ec152d2-fe90-4a16-a53b-1d814aad91a8 68788-9111 HUMAN PRESCRIPTION DRUG IBUPROFEN Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Preferred Pharmaceuticals, Inc IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9112_3ec152d2-fe90-4a16-a53b-1d814aad91a8 68788-9112 HUMAN PRESCRIPTION DRUG IBUPROFEN Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Preferred Pharmaceuticals, Inc IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9113_30343076-a968-45ae-b341-84c621e628f4 68788-9113 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Preferred Pharmaceuticals, Inc IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9114_30343076-a968-45ae-b341-84c621e628f4 68788-9114 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Preferred Pharmaceuticals, Inc IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9115_30343076-a968-45ae-b341-84c621e628f4 68788-9115 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Preferred Pharmaceuticals, Inc IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9116_c1b2fea4-7b5a-43c7-9834-5c734fc920ad 68788-9116 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20040830 ANDA ANDA087425 Preferred Pharmaceuticals, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] 68788-9117_af82a6f7-64bf-4274-a70d-0a14b58c3961 68788-9117 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 20110531 ANDA ANDA075273 Preferred Pharmaceuticals, Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68788-9118_f3ea45e6-0c8d-47cd-ac99-ffd7d47af443 68788-9118 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 Preferred Pharmaceuticals, Inc PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9120_0f09bcda-5041-48f6-8107-2785875efd51 68788-9120 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone neomycin sulfate, polymyxin b sulfate and dexamethasone SUSPENSION OPHTHALMIC 19960221 ANDA ANDA062341 Preferred Pharmaceuticals, Inc DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9121_edc03446-1b59-4f1a-a5a6-46d071c11bce 68788-9121 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Preferred Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68788-9122_edc03446-1b59-4f1a-a5a6-46d071c11bce 68788-9122 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Preferred Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68788-9124_7a0bba98-8f39-4020-b2a5-c487278a057a 68788-9124 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET ORAL 19940325 ANDA ANDA040353 Preferred Pharmaceuticals, Inc SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 68788-9125_24029270-25a9-40eb-ad9b-fb935b0472d7 68788-9125 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20110901 ANDA ANDA040656 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 68788-9126_2d190efb-2129-4b39-8671-7cacb89b5c15 68788-9126 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Preferred Pharmaceuticals, Inc ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 68788-9127_2d190efb-2129-4b39-8671-7cacb89b5c15 68788-9127 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Preferred Pharmaceuticals, Inc ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 68788-9128_add47035-af93-46be-a1e9-d77c2a3d6600 68788-9128 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20050628 ANDA ANDA076716 Preferred Pharmaceuticals, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 68788-9129_361b5973-e138-49b5-b52a-54d73e0f9cca 68788-9129 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20040721 ANDA ANDA087479 Preferred Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 68788-9131_21f5c7f4-344d-4fd3-bf24-be32eaf97e03 68788-9131 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl Phenazopyridine HCl TABLET ORAL 20100910 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 68788-9132_21f5c7f4-344d-4fd3-bf24-be32eaf97e03 68788-9132 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl Phenazopyridine HCl TABLET ORAL 20100910 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 68788-9133_4108b906-36c7-408a-a8dd-902da01b639c 68788-9133 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20140102 OTC MONOGRAPH NOT FINAL part343 Preferred Pharmaceuticals, Inc. IBUPROFEN 200 mg/1 68788-9135_7466b9b8-36af-44a0-a248-1b09cbec6d94 68788-9135 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 Preferred Pharmaceuticals, Inc ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 68788-9137_151f416e-07d7-4429-88e0-9bb079035c2d 68788-9137 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20090909 ANDA ANDA040655 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 68788-9138_8f8594bc-cb61-4f02-9954-7a961c48d36f 68788-9138 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Preferred Pharmaceuticals, Inc ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68788-9141_bc60f74e-872e-48e6-95be-960e9d1dbfd4 68788-9141 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20110722 ANDA ANDA040355 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 68788-9146_97ce900d-b32b-4c72-8af7-419f1fe914c4 68788-9146 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110813 ANDA ANDA076361 Preferred Pharmaceuticals, Inc LEVOFLOXACIN 750 mg/1 68788-9148_2c2f172b-e780-49f6-8af4-1a9d87251fe8 68788-9148 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110813 ANDA ANDA076361 Preferred Pharmaceuticals, Inc LEVOFLOXACIN 500 mg/1 68788-9149_483428f4-7df8-43f9-9567-1fdcc4f85bf7 68788-9149 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20110101 ANDA ANDA077836 Preferred Pharmaceuticals, Inc GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 68788-9150_0f50125a-6d89-4b2b-b48b-daac6129182c 68788-9150 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Preferred Pharmaceuticals, Inc ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68788-9151_db142333-5880-44ed-9fc7-db21bff3c66e 68788-9151 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Preferred Pharmaceuticals, Inc NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9152_2289900b-889b-4536-9ed0-3bddb20c9387 68788-9152 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20050923 ANDA ANDA065170 Preferred Pharmaceuticals, Inc MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 68788-9154_a8da6642-94c4-495a-86d6-8c073b73f33c 68788-9154 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20110308 ANDA ANDA075536 Preferred Pharmaceuticals, Inc DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68788-9155_c49835ea-8850-4bae-8968-398ad4cb7980 68788-9155 HUMAN OTC DRUG Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20090317 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc OXYMETAZOLINE HYDROCHLORIDE 5 g/100mL 68788-9156_8e2849ce-084f-4900-b5ba-ab7726b4a182 68788-9156 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68788-9157_65ced429-1cad-4023-a4da-8acc71cf953d 68788-9157 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68788-9158_eb09a435-0600-494a-801f-3d9c32648a11 68788-9158 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20110922 ANDA ANDA040377 Preferred Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 68788-9159_a3524443-47b2-46ac-b8d5-d276b612c9e4 68788-9159 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68788-9160_3440fa05-8159-41bf-8236-277f6ba0e213 68788-9160 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68788-9161_e8683375-1726-4761-9ba8-cf3455f59551 68788-9161 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68788-9162_13275af8-a429-4c74-a6b1-90489a82ef7d 68788-9162 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68788-9163_4d2358b7-94a3-4f0e-b3ea-5701883046a6 68788-9163 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68788-9164_f35e4787-f636-4ad7-8381-065feb891efa 68788-9164 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68788-9165_e0261137-e0c7-4001-a55a-6575d16fcd16 68788-9165 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68788-9168_a248280a-a0d1-4fd6-9fd5-16632db8e309 68788-9168 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68788-9172_cca0ec29-4b48-4d2d-9117-2f60400ffab8 68788-9172 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20080610 ANDA ANDA086414 Preferred Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g 68788-9175_4cf70d03-f989-4c7e-9d9a-9609210147af 68788-9175 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20101231 ANDA ANDA090066 Preferred Pharmaceuticals, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9176_a64bfad9-b711-49cb-9e09-0bf97d0cf956 68788-9176 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20110425 ANDA ANDA074305 Preferred Pharmaceuticals,Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68788-9177_69677bc9-8f1b-4191-ab1f-4f274df3f3d3 68788-9177 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20110721 ANDA ANDA040256 Preferred Pharmaceuticals, Inc. PREDNISONE 5 mg/1 68788-9178_34579c05-a0b3-4ded-af08-4c1a8daa2516 68788-9178 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20110721 ANDA ANDA040256 Preferred Pharmaceuticals, Inc. PREDNISONE 10 mg/1 68788-9179_0cf2c4d3-9df2-4de2-8fac-e8081e63354c 68788-9179 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20110721 ANDA ANDA040392 Preferred Pharmaceuticals, Inc. PREDNISONE 20 mg/1 68788-9180_c9a957b3-1d7f-4f61-a7d7-38f2edbeb69b 68788-9180 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20051027 ANDA ANDA075828 Preferred Pharmaceuticals, Inc LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-9181_ec92b6a0-7a4c-4a17-99a4-a867dcb621c0 68788-9181 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20051027 ANDA ANDA075828 Preferred Pharmaceuticals, Inc LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-9182_535a477c-f742-4033-be18-05ec78414357 68788-9182 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20051027 ANDA ANDA075828 Preferred Pharmaceuticals, Inc LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-9183_2eac48a8-a07d-430a-9315-81da24b51845 68788-9183 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19730919 ANDA ANDA083426 Preferred Pharmaceuticals, Inc PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68788-9184_12789360-0d40-4cf3-99a3-271920752a55 68788-9184 HUMAN OTC DRUG Q-Tapp Brompheniramine maleate and Pseudoephedrine hydrochloride ELIXIR ORAL 20010405 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 15 mg/5mL; mg/5mL 68788-9185_759e2ff2-a63a-4bf2-bf93-b1a69836ec23 68788-9185 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 20100518 ANDA ANDA075281 Preferred Pharmaceuticals, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9190_5447f51d-4ed4-4f1f-9391-e788ba64a3f1 68788-9190 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20141027 ANDA ANDA077253 Preferred Pharmaceuticals, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68788-9196_cbdc71e9-13ed-4f0e-b0b2-4864a46b7852 68788-9196 HUMAN OTC DRUG Extra Strength QPAP Acetaminophen TABLET ORAL 20111103 OTC MONOGRAPH NOT FINAL part343 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN 500 mg/1 68788-9199_40f293da-e62e-4a5d-9423-6dc44954e99c 68788-9199 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20091123 ANDA ANDA076003 Preferred Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68788-9203_c782dfc3-4d5e-432c-b576-bd1aeb0fe300 68788-9203 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19960718 ANDA ANDA064030 Preferred Pharmaceuticals, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68788-9204_a71358c4-0e8f-4d48-9e25-7fbfba7fecec 68788-9204 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20040514 ANDA ANDA076622 Preferred Pharmaceuticals, Inc OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68788-9205_153d3376-4e38-4f5e-8bf7-4b77bcbb2ebe 68788-9205 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20100420 ANDA ANDA074754 Preferred Pharmaceuticals, Inc KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9207_887e88a1-0802-4bc3-a9f3-5af501a6cfe9 68788-9207 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20111109 ANDA ANDA071322 Preferred Pharmaceuticals, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9208_887e88a1-0802-4bc3-a9f3-5af501a6cfe9 68788-9208 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20111109 ANDA ANDA071321 Preferred Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9209_d502f0d7-da39-4e39-849a-d3eaa2dd42c1 68788-9209 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20111108 ANDA ANDA063083 Preferred Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 68788-9212_14603059-8773-43b1-adb5-ff3fbed2e5d8 68788-9212 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20111110 ANDA ANDA070974 Preferred Pharmaceuticals, Inc CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68788-9213_7ced4016-b788-4256-8dbe-94e1e6b392f6 68788-9213 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20111110 ANDA ANDA070975 Preferred Pharmaceuticals, Inc CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68788-9214_e15653c8-f0e0-4520-b4d0-b6dfc5619728 68788-9214 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 20111110 ANDA ANDA070925 Preferred Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68788-9215_84c72316-dca6-4811-b623-8022dbc6f41f 68788-9215 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20141110 ANDA ANDA087022 Preferred Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 68788-9218_33d17918-0658-4783-8045-cdeb51dc0e08 68788-9218 HUMAN PRESCRIPTION DRUG MethylPREDNISolone methylprednisolone TABLET ORAL 20141008 ANDA ANDA040183 Preferred Pharmaceuticals, Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9219_5683885d-461c-4e7e-bbe8-dc231d706192 68788-9219 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20140919 ANDA ANDA076592 Preferred Pharmaceuticals, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9220_7be0dbac-8282-4a41-b2ad-577deae16712 68788-9220 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075718 Preferred Pharmaceuticals, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68788-9221_eb058d7b-fb5d-46fe-bf1a-942d075db0fd 68788-9221 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20141013 NDA NDA021342 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68788-9222_cbfe24cb-42f0-43a0-a739-4cc842283e4e 68788-9222 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Preferred Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9223_65219191-9a11-4894-a38f-91cedd005533 68788-9223 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Preferred Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9224_740fd60b-ebb8-493b-aadb-55eee80f09fe 68788-9224 HUMAN OTC DRUG PHAZYME Simethicone CAPSULE, GELATIN COATED ORAL 20141014 OTC MONOGRAPH FINAL part332 Preferred Pharmaceuticals, Inc. DIMETHICONE 180 mg/1 68788-9225_fe6ed22b-f41f-4fae-9092-6c1253e09bd6 68788-9225 HUMAN OTC DRUG Virtussin AC Codeine Phosphate and Guaifenesin LIQUID ORAL 20141006 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 68788-9226_fd3ac5d4-f240-4f3d-a76f-67702a92feca 68788-9226 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Preferred Pharmaceuticals, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 68788-9227_3befad3c-b6fb-495a-a4d0-9893ec13e4c4 68788-9227 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20141017 ANDA ANDA089424 Preferred Pharmaceuticals, Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 68788-9228_3bb48a8e-d600-4af3-827d-4fee612d672c 68788-9228 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20141112 ANDA ANDA077859 Preferred Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68788-9229_80accf43-494a-48cb-98e0-6ff27bc0838f 68788-9229 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20141016 ANDA ANDA202800 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 68788-9230_12901032-a38c-4ce5-9ce5-a869c3971832 68788-9230 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20141020 ANDA ANDA090082 Preferred Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9231_4cf70d03-f989-4c7e-9d9a-9609210147af 68788-9231 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA090066 Preferred Pharmaceuticals, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9232_acdb92ef-d91b-463c-9abb-a10b2b55cee6 68788-9232 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20141006 ANDA ANDA201384 Preferred Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68788-9233_91b3473d-b95b-4b7d-a1d4-3ff2cb75a9b9 68788-9233 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19921029 NDA AUTHORIZED GENERIC NDA020246 Preferred Pharmaceuticals, Inc MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 68788-9234_eb058d7b-fb5d-46fe-bf1a-942d075db0fd 68788-9234 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20141013 NDA NDA021342 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68788-9235_eb058d7b-fb5d-46fe-bf1a-942d075db0fd 68788-9235 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20141013 NDA NDA021342 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68788-9236_b2d04a26-408f-4d18-82e8-66fe4092a78d 68788-9236 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20141009 ANDA ANDA073025 Preferred Pharmaceuticals, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68788-9237_acdb92ef-d91b-463c-9abb-a10b2b55cee6 68788-9237 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20141006 ANDA ANDA201384 Preferred Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68788-9238_77d38000-3d3d-4d05-a74a-2fcc11849ae7 68788-9238 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20141013 ANDA ANDA091153 Preferred Pharmaceuticals, Inc. ESZOPICLONE 3 mg/1 CIV 68788-9245_82af879c-9ecf-4f9a-b00f-779ab4104a2f 68788-9245 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20141027 ANDA ANDA077731 Preferred Pharmaceuticals, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68788-9246_58416ceb-994f-4571-afbd-c2171823f528 68788-9246 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20141022 ANDA ANDA078220 Preferred Pharmaceuticals, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 68788-9247_28051258-478b-4c8e-ab48-3c3f40de2321 68788-9247 HUMAN PRESCRIPTION DRUG nystatin nystatin CREAM TOPICAL 20141113 ANDA ANDA062129 Preferred Pharmaceuticals, Inc. NYSTATIN 100000 [USP&apos'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 68788-9249_142b1561-4310-494e-8a82-662c12de2cd1 68788-9249 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20141120 ANDA ANDA091643 Preferred Pharmaceuticals, Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 68788-9250_1bf4d591-b3c6-42c6-b038-ef1f52cfdf68 68788-9250 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141103 ANDA ANDA040736 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 68788-9251_aff1aa12-5f9d-4ba8-875b-cf804f371111 68788-9251 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141127 ANDA ANDA079095 Preferred Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68788-9254_30f408b6-5344-47c2-8084-d465bc094cdf 68788-9254 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20141201 ANDA ANDA077056 Preferred Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68788-9255_f9378e0d-f502-4f8c-b953-713e4b36cf02 68788-9255 HUMAN PRESCRIPTION DRUG bupropion bupropion TABLET, EXTENDED RELEASE ORAL 20141103 ANDA ANDA201567 Preferred Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68788-9259_ce06497d-12a6-4e79-967e-378b3a7dd61d 68788-9259 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 20141113 ANDA ANDA089828 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 68788-9261_27a9570c-78cd-45f1-87b5-83eea59d5099 68788-9261 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED ORAL 20141111 ANDA ANDA077184 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68788-9262_076af3a1-bbf6-407c-90c2-51a61eace283 68788-9262 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20141125 ANDA ANDA090778 Preferred Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9263_30f408b6-5344-47c2-8084-d465bc094cdf 68788-9263 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20141201 ANDA ANDA077056 Preferred Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68788-9264_86eab8ac-b66c-4edf-9f76-0af9dbb7abc9 68788-9264 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20131113 ANDA ANDA040755 Preferred Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 68788-9265_4df20000-01dd-4a82-b5d5-0177d8b219fd 68788-9265 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20141203 ANDA ANDA077614 Preferred Pharmaceuticals,Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68788-9266_e89e6f78-1769-42de-828b-376893a40710 68788-9266 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20141118 ANDA ANDA090723 Preferred Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9330_7feaf530-8124-4171-a5d8-18f1f7dcf30d 68788-9330 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20141021 ANDA ANDA076794 Preferred Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68788-9331_ed5e565c-cf5a-4236-ba5b-fb4c4fc79704 68788-9331 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20141020 ANDA ANDA090637 Preferred Pharmaceuticals, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 68788-9333_bb93e48c-b988-4eac-83d5-1c82aeb951d1 68788-9333 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20140918 ANDA ANDA065166 Preferred Pharmaceuticals, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68788-9338_9c4c44f5-33fd-4829-829f-caa132e90475 68788-9338 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20141008 NDA NDA022122 Preferred Pharmaceuticals, Inc. DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9345_01139e81-a4fa-4e13-acdf-c75c79a1aa9c 68788-9345 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20141124 ANDA ANDA078925 Preferred Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68788-9361_0755ade3-edbc-4b34-b261-99b15b759599 68788-9361 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20141020 ANDA ANDA091153 Preferred Pharmaceuticals, Inc. ESZOPICLONE 1 mg/1 CIV 68788-9367_9fb9e559-6941-439f-882a-4447a509680e 68788-9367 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20141119 ANDA ANDA090082 Preferred Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9368_b6b103c6-8101-425f-b619-1f711b124d9e 68788-9368 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20140612 ANDA ANDA078539 Preferred Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68788-9370_2ce7fff4-28ac-4723-bc1d-bab4ad3b4fb8 68788-9370 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140820 ANDA ANDA202045 Preferred Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9371_2ce7fff4-28ac-4723-bc1d-bab4ad3b4fb8 68788-9371 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140820 ANDA ANDA202045 Preferred Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9372_481c16d5-bba3-4fd7-b7bf-df1339bdeedc 68788-9372 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20141007 ANDA ANDA079067 Preferred Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 68788-9373_b12866e9-92ce-4c17-8b5d-fa755dd717ef 68788-9373 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin, Polymyxin B Sulfates, Dexamethasone OINTMENT OPHTHALMIC 20140902 ANDA ANDA062938 Preferred Pharmaceuticals, Inc. DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 68788-9374_490c0e17-0df1-46e1-9666-436a7613e499 68788-9374 HUMAN PRESCRIPTION DRUG Fenoprofen fenoprofen CAPSULE ORAL 20140820 NDA NDA017604 Preferred Pharmaceuticals, Inc. FENOPROFEN CALCIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9375_9f2ed180-1a04-4a94-ae91-644f4aba455e 68788-9375 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140908 ANDA ANDA078866 Preferred Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68788-9376_6424580d-31af-4ba6-9755-283de288b63d 68788-9376 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20141125 ANDA ANDA090200 Preferred Pharmaceuticals, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68788-9378_a3a6575c-b896-4670-aecc-f77061fc701b 68788-9378 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20140728 ANDA ANDA074569 Preferred Pharmaceuticals, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9379_a3a6575c-b896-4670-aecc-f77061fc701b 68788-9379 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20140728 ANDA ANDA074569 Preferred Pharmaceuticals, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9380_6a8b9b84-9942-4edd-8df9-319880d2feab 68788-9380 HUMAN PRESCRIPTION DRUG cilostazol cilostazol TABLET ORAL 20140728 ANDA ANDA077030 Preferred Pharmaceuticals, Inc. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] 68788-9381_9a002ccd-8547-4d69-8955-b54f578fa465 68788-9381 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20140730 ANDA ANDA073085 Preferred Pharmaceuticals, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9385_09442938-34d5-495f-8833-73cf1e7131c9 68788-9385 HUMAN PRESCRIPTION DRUG promethazine hydrochloride and codeine phosphate promethazine hydrochloride and codeine phosphate SYRUP ORAL 20140722 ANDA ANDA090180 Preferred Pharmaceuticals, Inc. CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 68788-9386_2b62abf5-54ed-47be-a4d7-4169c005e2e5 68788-9386 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20140723 ANDA ANDA201507 Preferred Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 68788-9387_eb058d7b-fb5d-46fe-bf1a-942d075db0fd 68788-9387 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20141013 NDA NDA021342 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] 68788-9388_89719699-695b-4592-bfef-0cdc300d9e3b 68788-9388 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20141118 ANDA ANDA086989 Preferred Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68788-9389_9a2df245-1b84-40ea-9f22-21f7c487ad76 68788-9389 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140717 NDA AUTHORIZED GENERIC NDA020254 Preferred Pharmaceuticals, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9390_edc03446-1b59-4f1a-a5a6-46d071c11bce 68788-9390 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Preferred Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 68788-9391_b9eae7c0-4a58-44c4-9e10-aef2dd379c5d 68788-9391 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS TOPICAL 20140703 ANDA ANDA077689 Preferred Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68788-9392_7d12557a-a156-4ca4-9926-a3da5addd65e 68788-9392 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20140703 ANDA ANDA077691 Preferred Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-9393_d8952bd4-927b-4bdf-8e13-95a08fca2784 68788-9393 HUMAN PRESCRIPTION DRUG erythromycin erythromycin OINTMENT OPHTHALMIC 20140703 ANDA ANDA062447 Preferred Pharmaceuticals, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68788-9394_80242590-6be9-41cd-8f1e-5fd89151e738 68788-9394 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN TABLET ORAL 20140624 OTC MONOGRAPH NOT FINAL part343 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN 500 mg/1 68788-9395_c6844506-6c8a-4ded-b15f-82f25991b934 68788-9395 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141119 ANDA ANDA201013 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 68788-9396_9fb9e559-6941-439f-882a-4447a509680e 68788-9396 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20141022 ANDA ANDA090082 Preferred Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9397_481c16d5-bba3-4fd7-b7bf-df1339bdeedc 68788-9397 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20131216 ANDA ANDA079067 Preferred Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 68788-9398_bb172b8f-f179-47bc-a369-486e123f88b1 68788-9398 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140617 ANDA ANDA201013 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 68788-9399_c14ae56d-f8ec-496e-b581-42267e1750b4 68788-9399 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20140616 OTC MONOGRAPH NOT FINAL part343 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN 500 mg/1 68788-9400_51cc682c-6b56-4fe9-bd95-09bdbe35e252 68788-9400 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole SHAMPOO, SUSPENSION TOPICAL 20140616 ANDA ANDA076942 Preferred Pharmaceuticals, Inc. KETOCONAZOLE 20.5 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68788-9401_0bcce31c-35cb-44f9-94fc-692a3fc74d9e 68788-9401 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20140616 ANDA ANDA040807 Preferred Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68788-9402_b6b103c6-8101-425f-b619-1f711b124d9e 68788-9402 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20140612 ANDA ANDA078539 Preferred Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68788-9403_a3c98d44-c77e-42ef-a52c-f46cacca7763 68788-9403 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20140617 ANDA ANDA040779 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 68788-9404_00362165-347f-4352-99b7-53bd5bca1648 68788-9404 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20140528 ANDA ANDA065253 Preferred Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68788-9405_e199dbfa-6d79-4c20-9984-9cd0c1907510 68788-9405 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20141103 ANDA ANDA080937 Preferred Pharmaceuticals, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] 68788-9406_09a7dc01-4657-48a8-884d-8444ff323b2f 68788-9406 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20140523 ANDA ANDA201921 Preferred Pharmaceuticals, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68788-9407_53048b99-bb1a-4821-94e2-b7999d5617b8 68788-9407 HUMAN OTC DRUG SENEXON-S DOCUSATE SODIUM -SENNOSIDES TABLET, COATED ORAL 20140521 OTC MONOGRAPH NOT FINAL part334 Preferred Pharmaceuticals, Inc. DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 68788-9411_92921e88-c9b8-4f12-8961-d544d0647f35 68788-9411 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20130502 ANDA ANDA203508 Preferred Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68788-9412_69d6802e-86b1-43f7-86ef-982ffd24511d 68788-9412 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140602 ANDA ANDA075492 Preferred Pharmaceuticals, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9413_c6844506-6c8a-4ded-b15f-82f25991b934 68788-9413 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140514 ANDA ANDA201013 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 68788-9414_572f5428-5978-4e3a-8877-ba514f382cc9 68788-9414 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine maleate TABLET ORAL 20140513 ANDA ANDA040268 Preferred Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68788-9415_85f47a6f-bd76-4369-bcb4-e70281a0ec28 68788-9415 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate and hydrocortisone SUSPENSION AURICULAR (OTIC) 20140513 ANDA ANDA062488 Preferred Pharmaceuticals, Inc. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9416_7bc58020-727f-483e-95de-15cbe327c673 68788-9416 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20141204 ANDA ANDA040114 Preferred Pharmaceuticals, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 68788-9418_cd7f1d6f-b735-454b-ab37-cd9fa83ad0c6 68788-9418 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20140507 ANDA ANDA077927 Preferred Pharmaceuticals, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9419_d9f3fd45-dba2-4013-9111-850fac3f6c47 68788-9419 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA090074 Preferred Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68788-9421_feebbae8-f226-45b2-b284-edf43b178fbb 68788-9421 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20140508 ANDA ANDA090931 Preferred Pharmaceuticals, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68788-9422_2722942a-7225-43bd-8814-52147fe6f7f2 68788-9422 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20140507 ANDA ANDA065308 Preferred Pharmaceuticals, Inc. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68788-9423_4bf6ac3d-78e9-4110-809b-791a36c11622 68788-9423 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride ER Diethylpropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140429 ANDA ANDA091680 Preferred Pharmaceuticals, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 68788-9424_5b7deb33-be18-400f-b03b-ef3e91a1743e 68788-9424 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20141113 ANDA ANDA065098 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 68788-9425_1a666faf-d9fa-4ed7-8d78-8372c024368f 68788-9425 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140418 NDA AUTHORIZED GENERIC NDA020699 Preferred Pharmaceuticals, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9426_f2d2677e-8bd1-4c1c-8991-ea07009490d5 68788-9426 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20140421 ANDA ANDA074356 Preferred Pharmaceuticals, Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] 68788-9429_e507e3f6-6690-4c93-922d-2b665cd23225 68788-9429 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20141021 ANDA ANDA078155 Preferred Pharmaceuticals, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-9432_67d48963-f7bb-438c-9ad6-45f753e3422f 68788-9432 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET ORAL 20140912 ANDA ANDA077478 Preferred Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68788-9433_c659b5fd-a52d-4e4c-b322-38c51fdca9ab 68788-9433 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20140908 ANDA ANDA201090 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 68788-9439_030edd89-4d48-4741-bebc-e22ec053613a 68788-9439 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, CHEWABLE ORAL 20140505 ANDA ANDA091588 Preferred Pharmaceuticals, Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 68788-9456_297e889d-d22b-476f-b4d8-3a51636fedd4 68788-9456 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20140925 ANDA ANDA090432 Preferred Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9463_de178171-a3a5-42c6-ad19-74e4668ab633 68788-9463 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20140521 ANDA ANDA077982 Preferred Pharmaceuticals, Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 68788-9479_bb310224-d5b6-4151-87e8-803bdce459c1 68788-9479 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20140414 ANDA ANDA040625 Preferred Pharmaceuticals, Inc. FOLIC ACID 1 mg/1 68788-9481_a1e2d82a-ff0d-46ae-a818-7ee540dcca47 68788-9481 HUMAN OTC DRUG ED A-HIST CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20140401 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 68788-9487_6de40b0a-870e-4322-9b5b-66ce876be96d 68788-9487 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20140423 ANDA ANDA202152 Preferred Pharmaceuticals, Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] 68788-9488_6b5d9180-ea2f-4bb7-9e88-b596b638cb1d 68788-9488 HUMAN OTC DRUG Double Antibiotic Bacitracin Zinc and Polymyxin B Sulfate OINTMENT TOPICAL 20140520 OTC MONOGRAPH FINAL part333B Preferred Pharmaceuticals, Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g 68788-9490_8626710e-571b-449a-8235-74f49b611732 68788-9490 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20140331 ANDA ANDA201504 Preferred Pharmaceuticals, Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] 68788-9492_a3edf23f-c1e7-49ef-8efe-5276b9bbebde 68788-9492 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20140402 ANDA ANDA077272 Preferred Pharmaceuticals, Inc. CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 68788-9493_7fa54999-fc16-49e4-ab62-ac3a5532cf37 68788-9493 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20140402 ANDA ANDA078488 Preferred Pharmaceuticals, Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 68788-9494_871a6920-da41-4869-ade2-ddc0fbb4b979 68788-9494 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20140402 ANDA ANDA071251 Preferred Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68788-9495_fa391ced-0648-483e-b926-a22e1d50993c 68788-9495 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20140402 ANDA ANDA077856 Preferred Pharmaceuticals, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9496_1402d6fc-73e9-4702-a2e3-71485d37122f 68788-9496 HUMAN OTC DRUG Terocin Methyl Salicylate, Capsaicin, Menthol and Lidocaine Hydrochloride LOTION TOPICAL 20140320 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc. CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE .025; 2.5; 10; 25 g/100mL; g/100mL; g/100mL; g/100mL 68788-9497_e47f2934-f961-4588-a218-b7f8b10d1163 68788-9497 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20140326 ANDA ANDA076533 Preferred Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68788-9499_5d4301d0-c224-4962-9bf3-118d754311f0 68788-9499 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20140314 ANDA ANDA090278 Preferred Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68788-9500_59ba0c26-2d7f-46de-af49-f034dace2c84 68788-9500 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20140305 ANDA ANDA076817 Preferred Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 68788-9501_dbb8a14f-bfa3-4357-9695-f5fbe5c5f70b 68788-9501 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20131203 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 68788-9502_71cb77d0-f315-4eb4-90b4-36155c1433b4 68788-9502 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20140801 ANDA ANDA040749 Preferred Pharmaceuticals, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 68788-9503_e08ba5ea-edb7-439a-8dda-4e1288cc4161 68788-9503 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130619 ANDA ANDA085161 Preferred Pharmaceuticals, Inc. PREDNISONE 20 mg/1 68788-9504_7397f901-7ce5-4751-a996-22d51d95a888 68788-9504 HUMAN PRESCRIPTION DRUG Ofloxacin Otic Ofloxacin SOLUTION AURICULAR (OTIC) 20140221 ANDA ANDA076527 Preferred Pharmaceuticals, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68788-9505_b4fc8a0e-978d-438c-a94d-7c9cc1ae2af8 68788-9505 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20140227 ANDA ANDA070035 Preferred Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 68788-9506_a9c09fd0-628b-4e80-961c-7873417fccc7 68788-9506 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20140225 ANDA ANDA040419 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 68788-9507_7a18a4f4-5487-4cf6-a46d-58369dc5833c 68788-9507 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20140228 ANDA ANDA075581 Preferred Pharmaceuticals, Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68788-9508_271fcc8d-e127-48d5-8f2e-e444c9ac45d3 68788-9508 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140226 ANDA ANDA078048 Preferred Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68788-9509_31b6dae3-2ddf-4a01-98e9-abe318a09963 68788-9509 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140228 ANDA ANDA090858 Preferred Pharmaceuticals, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68788-9510_8a3f2fd8-d8a0-4307-85b6-ff9217b54324 68788-9510 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140218 ANDA ANDA202038 Preferred Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68788-9511_8e44d4f5-eb44-49ba-9570-298c14359694 68788-9511 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140205 ANDA ANDA078203 Preferred Pharmaceuticals, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 68788-9512_bbad2036-e2a8-4c56-bb92-dea833598ebc 68788-9512 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 20140212 ANDA ANDA091348 Preferred Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 68788-9513_6e3d5abd-f89a-4404-a8cb-be87fa4feeaf 68788-9513 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140303 ANDA ANDA083677 Preferred Pharmaceuticals, Inc. PREDNISONE 20 mg/1 68788-9514_e47f2934-f961-4588-a218-b7f8b10d1163 68788-9514 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20140305 ANDA ANDA076533 Preferred Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68788-9515_0696e79f-4411-41ca-9d5a-6b3e47501a94 68788-9515 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140305 ANDA ANDA090797 Preferred Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68788-9516_d234e9b2-2a9e-405b-a60e-9132352b679f 68788-9516 HUMAN PRESCRIPTION DRUG Nystatin Nystatin OINTMENT TOPICAL 20140210 ANDA ANDA062472 Preferred Pharmaceuticals, Inc. NYSTATIN 100000 [USP&apos'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 68788-9517_24934770-72cc-4a08-b557-f1c53ccfc923 68788-9517 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20130206 ANDA ANDA076436 Preferred Pharmaceuticals, Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 68788-9518_4bb3d1fa-746c-41ed-9662-22950343ea93 68788-9518 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate OINTMENT TOPICAL 20140305 ANDA ANDA074407 Preferred Pharmaceuticals, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9519_db499a51-42f2-40bd-afe6-b2a715e723be 68788-9519 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET ORAL 20140206 ANDA ANDA090061 Preferred Pharmaceuticals, Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 68788-9520_494ea722-450d-48bd-9f6e-f46a1c04caf6 68788-9520 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20140206 NDA NDA020987 Preferred Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68788-9521_65bed6d5-6e85-49f2-a6e5-8ca7a556cc2c 68788-9521 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20140206 ANDA ANDA065509 Preferred Pharmaceuticals, Inc. AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68788-9522_e3baaa92-8668-441c-a2cc-ca4f85e67d4a 68788-9522 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride hydroxyzine hydrochloride SOLUTION ORAL 20140206 ANDA ANDA040010 Preferred Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 68788-9523_e5ccad39-ddab-4dff-b8ff-be00a2d96f06 68788-9523 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140203 ANDA ANDA076201 Preferred Pharmaceuticals, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9524_58571c86-e748-43a8-aed3-30750047efac 68788-9524 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140127 ANDA ANDA077284 Preferred Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68788-9525_0df8f80b-e05c-4f6f-b055-3dde08a1b7b4 68788-9525 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 20140221 ANDA ANDA085223 Preferred Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 68788-9526_0501592b-f7bf-4b0e-bae1-89ddc3ad8fc1 68788-9526 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20140120 ANDA ANDA079132 Preferred Pharmaceuticals, Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68788-9527_ceb35d45-acd5-4980-baf7-f572e39f30f5 68788-9527 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131223 ANDA ANDA075743 Preferred Pharmaceuticals, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68788-9529_65bed6d5-6e85-49f2-a6e5-8ca7a556cc2c 68788-9529 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20140206 ANDA ANDA065507 Preferred Pharmaceuticals, Inc. AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68788-9530_13602c1d-d1c9-496b-baa6-8dee92519d67 68788-9530 HUMAN PRESCRIPTION DRUG Amantadine HCl AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20131220 ANDA ANDA078720 Preferred Pharmaceuticals, Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] 68788-9532_a54d4f0a-d09d-436e-ab89-bba88e07a9bc 68788-9532 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20131218 ANDA ANDA090278 Preferred Pharmacetucals, Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68788-9533_a54d4f0a-d09d-436e-ab89-bba88e07a9bc 68788-9533 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20131218 ANDA ANDA090278 Preferred Pharmacetucals, Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68788-9534_b78a92bc-6cd6-4808-84a3-861e95797409 68788-9534 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20140825 ANDA ANDA202248 Preferred Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 68788-9535_a49142e8-e6aa-4904-9632-4a690ae953f0 68788-9535 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20141022 ANDA ANDA077901 Preferred Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 68788-9536_ceb35d45-acd5-4980-baf7-f572e39f30f5 68788-9536 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131203 ANDA ANDA075743 Preferred Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68788-9537_dbb8a14f-bfa3-4357-9695-f5fbe5c5f70b 68788-9537 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20131203 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 68788-9538_07631a8b-eb84-46aa-844e-e93e548cb9b2 68788-9538 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20131203 ANDA ANDA062703 Preferred Pharmaceuticals, Inc. CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68788-9539_07631a8b-eb84-46aa-844e-e93e548cb9b2 68788-9539 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20131203 ANDA ANDA062703 Preferred Pharmaceuticals, Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68788-9542_611724e3-af8a-4e1c-9d45-6855905c2f92 68788-9542 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 20131105 ANDA ANDA074224 Preferred Pharmaceuticals, Inc. TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9543_1f0e63f9-ea9d-4aff-94a5-530c0709d127 68788-9543 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SOLUTION ORAL 20131113 ANDA ANDA040891 Preferred Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68788-9545_71d300eb-b3fc-46b2-a23b-295c1eefc425 68788-9545 HUMAN PRESCRIPTION DRUG PrednisoLONE Prednisolone SYRUP ORAL 20131025 ANDA ANDA040775 Preferred Pharmaceuticals, Inc. PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9546_2b18b5db-2657-4b32-b034-52d97c797938 68788-9546 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20131022 ANDA ANDA077789 Preferred Pharmaceuticals, Inc. CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] 68788-9547_f2e7d756-1e12-462a-a43f-a9d860b11ee8 68788-9547 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20131024 ANDA ANDA078327 Preferred Pharmaceuticals, Inc. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68788-9548_c9533697-1607-4a96-a6ff-15b775919d37 68788-9548 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131114 ANDA ANDA201043 Preferred Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 68788-9549_8147caca-8c23-464b-a3ec-b549e9880684 68788-9549 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20131230 ANDA ANDA075786 Preferred Pharmaceuticals, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68788-9550_1e958146-6457-44e4-967f-aec7f599679e 68788-9550 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20131022 ANDA ANDA202477 Preferred Pharmaceuuticals, Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68788-9551_f89bd1dc-88cd-4aef-a7ae-6310f38a3423 68788-9551 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140423 ANDA ANDA040256 Preferred Pharmaceuticals, Inc. PREDNISONE 5 mg/1 68788-9552_acc9a53e-304d-44e4-b4ab-5303d1361118 68788-9552 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20131010 NDA NDA020983 Preferred Pharmaceuticals, Inc. ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 68788-9553_dead7515-8312-4c37-8cd8-e47b51e7ed60 68788-9553 HUMAN OTC DRUG Berri-Freez MENTHOL GEL TOPICAL 20131007 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc. MENTHOL 4.5 g/100g 68788-9554_8ef17b69-b81a-4df4-b738-0c602d99184b 68788-9554 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED ORAL 20131003 ANDA ANDA090216 Preferred Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68788-9555_23843354-e242-4a8a-8818-897592d4d9a0 68788-9555 HUMAN OTC DRUG Terocin Lidocaine, Menthol PATCH TOPICAL 20130923 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc. LIDOCAINE; MENTHOL 600; 600 mg/1; mg/1 68788-9556_a61b1da3-cc66-41ef-8de1-494bcee448c6 68788-9556 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130415 ANDA ANDA090548 Preferred Pharmaceuticals, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-9557_b84682bf-0693-4f22-8ebf-36870072d55b 68788-9557 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20131118 ANDA ANDA091231 Preferred Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68788-9558_9ea01674-ef5f-49ec-a9c2-300bb12d6254 68788-9558 HUMAN OTC DRUG Natural Fiber Therapy Natural Laxative Psyllium Husk POWDER, FOR SOLUTION ORAL 20131114 OTC MONOGRAPH NOT FINAL part334 Preferred Pharmaceuticals, Inc. PSYLLIUM HUSK 3.4 g/7g 68788-9559_b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da 68788-9559 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20130827 ANDA ANDA090469 Preferred Pharmaceuticals, Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68788-9660_f9bdd283-ac31-47a8-9ed0-c2e7d524ff0d 68788-9660 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20130822 ANDA ANDA090901 Preferred Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68788-9661_ceb35d45-acd5-4980-baf7-f572e39f30f5 68788-9661 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131203 ANDA ANDA075743 Preferred Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68788-9662_39e14cf5-2463-41e1-95cc-5df97b2a3052 68788-9662 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 20130816 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc. HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9664_5521d2b6-c792-424c-b6cd-680c3d2e2c10 68788-9664 HUMAN PRESCRIPTION DRUG Quazepam QUAZEPAM TABLET ORAL 20130815 NDA NDA018708 Preferred Pharmaceuticals, Inc. QUAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9665_624827d6-dbf8-4f3d-a8c0-c92474cad7de 68788-9665 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM VAGINAL 20130805 ANDA ANDA072641 Preferred Pharmaceuticals, Inc. CLOTRIMAZOLE 1 g/100g 68788-9666_3c1a0020-f3aa-49c9-89ff-b5c548494619 68788-9666 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 20130805 ANDA ANDA062447 Preferred Pharmaceuticals, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68788-9667_ea4df37b-21e9-4dc3-83af-1be1b50bfdc9 68788-9667 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130725 ANDA ANDA075991 Preferred Pharmaceuticals, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-9668_ea4df37b-21e9-4dc3-83af-1be1b50bfdc9 68788-9668 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130729 ANDA ANDA075991 Preferred Pharmaceuticals, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-9669_dbc0f86b-55e7-4667-a26e-47b948f608bd 68788-9669 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130725 ANDA ANDA078866 Preferred Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68788-9670_4b6ef4cb-4993-494a-bf52-901e545d1a81 68788-9670 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20130724 ANDA ANDA090469 Preferred Pharmaceuticals, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68788-9671_ab008c38-bea4-4484-a2f8-627def008a5c 68788-9671 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20130606 OTC MONOGRAPH FINAL part343 Preferred Pharmaceuticals, Inc. ASPIRIN 81 mg/1 68788-9672_324acb82-06c4-4c53-9113-e0a297568fa9 68788-9672 HUMAN OTC DRUG LenzaGel LIDOCAINE HYDROCHLORIDE, MENTHOL GEL TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g 68788-9673_333dfa43-3554-48e9-ab02-429ea4020c2b 68788-9673 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20130712 ANDA ANDA075498 Preferred Pharmaceuticals, Inc. TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68788-9675_e5ffa951-ec5f-47b4-8dba-09466ca0f47c 68788-9675 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20130624 ANDA ANDA075580 Preferred Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68788-9676_8c5eb53a-841e-4ee8-acd1-fb4b33460613 68788-9676 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20130515 NDA NDA021134 Preferred Pharmaceuticals, Inc. NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 68788-9677_db0df90b-3f42-4288-ae23-c83aea044a45 68788-9677 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130604 ANDA ANDA077255 Preferred Pharmaceuticals, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] 68788-9678_4916301d-bcc8-4cd1-86b4-7bf0aecfbf68 68788-9678 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20130422 ANDA ANDA077538 Preferred Pharmaceuticals, Inc. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9679_45fab260-6959-4d43-984f-2ce4c6d557f1 68788-9679 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20130424 ANDA ANDA040863 Preferred Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68788-9680_484749dc-5abc-4f55-9e46-ac6b71c81026 68788-9680 HUMAN PRESCRIPTION DRUG Naphazoline Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20130422 ANDA ANDA083590 Preferred Pharmaceuticals, Inc. NAPHAZOLINE HYDROCHLORIDE 1 mg/mL 68788-9681_a61b1da3-cc66-41ef-8de1-494bcee448c6 68788-9681 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130415 ANDA ANDA090548 Preferred Pharmaceuticals, Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-9682_e42cc3b5-35fe-4805-9515-8224c075a203 68788-9682 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20130422 ANDA ANDA090871 Preferred Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9683_a61b1da3-cc66-41ef-8de1-494bcee448c6 68788-9683 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130415 ANDA ANDA090548 Preferred Pharmaceuticals, Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-9684_4cb3471c-c68f-48f6-a5d0-ebaa2531c0ef 68788-9684 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET ORAL 20130423 ANDA ANDA078536 Preferred Pharmaceuticals, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 68788-9685_487de613-59a5-480d-9556-6b9790a4a56e 68788-9685 HUMAN OTC DRUG Senna-Lax Sennosides TABLET ORAL 20130328 OTC MONOGRAPH NOT FINAL part334 Preferred Pharmaceuticals, Inc. SENNOSIDES A AND B 8.6 mg/1 68788-9686_8d79ceac-bb0d-4d84-a301-afeb32dc877c 68788-9686 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20130328 ANDA ANDA078459 Preferred Pharmaceuticals, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68788-9687_47be0d84-89b8-4e16-a87a-599d7e74467c 68788-9687 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20130327 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 68788-9688_47be0d84-89b8-4e16-a87a-599d7e74467c 68788-9688 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20100127 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 68788-9690_e7591486-afb6-495a-889e-e6c5a8581786 68788-9690 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20130326 ANDA ANDA075090 Preferred Pharmaceuticals, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68788-9691_b6a1bb7f-d5c4-4859-8471-a3a1036f26ed 68788-9691 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130327 ANDA ANDA078332 Preferred Pharmaceuticals, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68788-9692_212a7dc4-1bcf-43b3-8515-4c509b2bb6e3 68788-9692 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20130326 ANDA ANDA078216 Preferred Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9693_c300ee1d-c1c5-442b-85d2-01a8a13e1935 68788-9693 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20130325 ANDA ANDA077397 Preferred Pharmaceuticals, Inc SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9694_23fe21de-9d46-4f88-af66-cb01fa757c78 68788-9694 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20130326 ANDA ANDA075356 Preferred Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9695_78b220b0-90f1-45b9-9dc7-3c36528c6361 68788-9695 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET ORAL 20130327 ANDA ANDA090722 Preferred Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 68788-9696_eb4df59b-db85-4c63-acbe-f432fc805d84 68788-9696 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20130422 ANDA ANDA088496 Preferred Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 68788-9697_1782e06f-32d5-4b49-bd34-1b34a9fcac64 68788-9697 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20130319 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 68788-9698_1782e06f-32d5-4b49-bd34-1b34a9fcac64 68788-9698 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20130319 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 68788-9699_c7aeab93-756e-4370-9989-8dfe3e2ff627 68788-9699 HUMAN PRESCRIPTION DRUG Hydroquinone Hydroquinone CREAM TOPICAL 20130318 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 68788-9700_c1545307-d2b3-4bf6-8789-fa49734470dc 68788-9700 HUMAN PRESCRIPTION DRUG cefuroxime axetil cefuroxime axetil TABLET ORAL 20130315 ANDA ANDA065135 Preferred Pharmaceuticals, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68788-9701_c1545307-d2b3-4bf6-8789-fa49734470dc 68788-9701 HUMAN PRESCRIPTION DRUG cefuroxime axetil cefuroxime axetil TABLET ORAL 20130315 ANDA ANDA065135 Preferred Pharmaceuticals, Inc. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68788-9702_449a6fd8-c2ac-40d0-b74a-e5c7fc6670f3 68788-9702 HUMAN PRESCRIPTION DRUG Neomycin Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 20130314 ANDA ANDA064135 Preferred Pharmaceuticals, Inc. DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9703_4acf4763-b978-4ca5-8e2d-e6f153bb4025 68788-9703 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20130308 ANDA ANDA065442 Preferred Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 68788-9704_6270ee8b-fa2c-4f06-8eaf-fc81716d9921 68788-9704 HUMAN OTC DRUG loperamide hydrochloride loperamide HCl LIQUID ORAL 20130308 ANDA ANDA091292 Preferred Pharmaceuticals, Inc. LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL 68788-9705_49190dbd-f329-4f2a-8534-1d05bc8fcdfc 68788-9705 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 20130218 ANDA ANDA085082 Preferred Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 68788-9706_5be0c7c9-2d88-46fc-8d7f-350969bb9d68 68788-9706 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20130206 ANDA ANDA071250 Preferred Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 68788-9707_bdf7dd97-2b9f-4a0c-b803-840b103ca12c 68788-9707 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110813 ANDA ANDA201043 Preferred Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 68788-9708_b58e29a9-890e-418a-bb97-55fbc588495d 68788-9708 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 20130205 ANDA ANDA075319 Preferred Pharmaceuticals, Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68788-9709_3bb4d8c3-d8b0-4f54-9267-13f2bf09176e 68788-9709 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20130204 ANDA ANDA090367 Preferred Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 68788-9710_70c451ca-3f09-4946-990a-588fdccaa1cf 68788-9710 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20130130 ANDA ANDA065271 Preferred Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 68788-9711_9621fe17-1b63-436e-b696-cb80e54baf5f 68788-9711 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine TABLET ORAL 20130130 ANDA ANDA089175 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325; 50; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] 68788-9712_093d61e0-645f-4ddd-8483-fef855dff764 68788-9712 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20130125 ANDA ANDA090083 Preferred Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 68788-9713_18a6b996-bd56-456e-8b60-d96d3c0b4193 68788-9713 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20130205 ANDA ANDA090836 Preferred Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68788-9714_ba84bc12-19b6-450b-aa51-b1655da3311b 68788-9714 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20130118 ANDA ANDA090432 Preferred Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9715_e05143f7-6d76-4492-9d49-7e3947d93c90 68788-9715 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20130114 ANDA ANDA088799 Preferred Pharmaceuticals, Inc HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9716_cf2403bc-73f2-45d4-bb44-527995304503 68788-9716 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20130110 ANDA ANDA077870 Preferred Pharmaceuticals, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 68788-9717_17d768ea-8b6f-4a0e-821c-20c187ba68a4 68788-9717 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20130107 ANDA ANDA077751 Preferred Pharmaceuticals, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-9718_da0a8f1e-44ad-4487-9bdc-ddbce9a23321 68788-9718 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20121220 ANDA ANDA078406 Preferred Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9719_da0a8f1e-44ad-4487-9bdc-ddbce9a23321 68788-9719 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20121220 ANDA ANDA078406 Preferred Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9721_eb4f916b-e9ef-4230-ad94-050985d2fca5 68788-9721 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 20121213 ANDA ANDA074532 Preferred Pharmaceuticals, Inc. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68788-9723_f0f88667-2888-4176-98ba-cac06b75bf32 68788-9723 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20121213 OTC MONOGRAPH FINAL part336 Preferred Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 68788-9724_3bb48a8e-d600-4af3-827d-4fee612d672c 68788-9724 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20121121 ANDA ANDA077859 Preferred Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68788-9725_7f8b11b9-68a3-4c82-9426-5048142243d7 68788-9725 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20121119 ANDA ANDA091569 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 68788-9726_7f8b11b9-68a3-4c82-9426-5048142243d7 68788-9726 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20121119 ANDA ANDA091568 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 68788-9727_e304d55a-7a2e-4635-9d02-b617933fb25a 68788-9727 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20121115 ANDA ANDA078387 Preferred Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9728_cf2403bc-73f2-45d4-bb44-527995304503 68788-9728 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20121114 ANDA ANDA077870 Preferred Pharmaceuticals, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] 68788-9729_6878653f-d45f-4ac5-8ac4-35f40307fc06 68788-9729 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20121031 ANDA ANDA091426 Preferred Pharmaceuticals, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 68788-9730_b1dd5fd3-010d-45ba-aebf-d4c7a4c74c61 68788-9730 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20121031 ANDA ANDA079153 Preferred Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68788-9731_eb4f916b-e9ef-4230-ad94-050985d2fca5 68788-9731 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 20121213 ANDA ANDA074532 Preferred Pharmaceuticals, Inc. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68788-9732_d1f5095e-199a-4be8-a1fb-7c01c5054ff9 68788-9732 HUMAN PRESCRIPTION DRUG Gentak Gentamicin Sulfate OINTMENT OPHTHALMIC 20121023 ANDA ANDA064093 Preferred Pharmaceuticals, Inc. GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 68788-9733_4bf2d51d-2944-4450-a817-1baec6a909ef 68788-9733 HUMAN PRESCRIPTION DRUG PREDNISOLONE ACETATE prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 20121023 NDA AUTHORIZED GENERIC NDA017011 Preferred Pharmaceuticals, Inc. PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9734_0349b228-0f87-41d3-9fce-4e1142005db2 68788-9734 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20121022 ANDA ANDA090182 Preferred Pharmaceuticals, Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL 68788-9735_5a2e876c-1255-47e3-90f9-7e3c8bc97114 68788-9735 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20120430 ANDA ANDA077068 Preferred Pharmaceuticals, Inc BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 68788-9737_10d5c641-e53c-40a3-b635-de4b612659a5 68788-9737 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20121008 ANDA ANDA040786 Preferred Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 68788-9738_b6a1bb7f-d5c4-4859-8471-a3a1036f26ed 68788-9738 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20121001 ANDA ANDA078332 Preferred Pharmaceuticals, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68788-9739_e72386cf-722b-4beb-ac18-b7ff89ad87ae 68788-9739 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120928 ANDA ANDA090796 Preferred Pharmaceuticals, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9740_e72386cf-722b-4beb-ac18-b7ff89ad87ae 68788-9740 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120928 ANDA ANDA090796 Preferred Pharmaceuticals, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9741_e72386cf-722b-4beb-ac18-b7ff89ad87ae 68788-9741 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120928 ANDA ANDA090796 Preferred Pharmaceuticals, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9742_ff347283-b9ce-4570-8501-43cab7e2ecc8 68788-9742 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 20120928 ANDA ANDA075191 Preferred Pharmaceuticals, Inc. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 68788-9743_9a5b9ba2-fe9b-495a-80a2-b8a317ad4538 68788-9743 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 19970819 ANDA ANDA085588 Preferred Pharmaceuticals, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 68788-9744_73506290-e863-4782-94d4-933b1fffccb9 68788-9744 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 Preferred Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 68788-9745_29e7e0cf-c294-4765-ae75-80a863687386 68788-9745 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20120925 NDA NDA050725 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 68788-9747_e507e3f6-6690-4c93-922d-2b665cd23225 68788-9747 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20120228 ANDA ANDA078155 Preferred Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-9748_4565de36-b28b-43b6-ac5a-de2ee9c05cd2 68788-9748 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20120110 ANDA ANDA076048 Preferred Pharmaceuticals, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68788-9749_79f0ef18-6c56-41d2-83c9-f358c23ccd80 68788-9749 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20120305 ANDA ANDA074132 Preferred Pharmaceuticals, Inc NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 68788-9750_8adb81e9-2ada-47be-bac8-990f25db9bf2 68788-9750 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20120130 ANDA ANDA076063 Preferred Pharmaceuticals, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68788-9751_b4dc1dde-c28e-43fd-9bbc-f0e0f6c8da60 68788-9751 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110531 20151031 ANDA ANDA090425 Preferred Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 68788-9752_a35fc563-9bf1-4242-92f8-638c6827eba1 68788-9752 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Preferred Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68788-9754_be430d5e-0007-431c-922f-29a546432d86 68788-9754 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen HYDROCODONE BITARTRATE, ACETAMINOPHEN TABLET ORAL 20120814 ANDA ANDA040846 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 68788-9756_3f3be283-2331-441a-90b5-4bfe9699a3b1 68788-9756 HUMAN OTC DRUG GERI-LANTA ANTACID ANTIGAS aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20120727 OTC MONOGRAPH FINAL part331 Preferred Pharmaceuticals, Inc. ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 68788-9764_c58da659-26ce-4af1-931d-9a2269b24ac7 68788-9764 HUMAN PRESCRIPTION DRUG Proctozone HC hydrocortisone CREAM TOPICAL 20120821 ANDA ANDA089682 Preferred Pharmaceuticals, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9769_b2718aa0-6714-4974-b8e1-7ddc117b7fe7 68788-9769 HUMAN OTC DRUG Pediatric Cough and Cold Medicine Chlorpheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide LIQUID ORAL 20120727 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 5; 15 mg/5mL; mg/5mL; mg/5mL 68788-9770_340f1a87-0bc6-46bf-8f16-80a5348ad15f 68788-9770 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20120727 ANDA ANDA077535 Preferred Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68788-9771_7b81c589-85d9-4f31-b110-c3da4cf6ea86 68788-9771 HUMAN OTC DRUG MILK OF MAGNESIA ORIGINAL magnesium hydroxide LIQUID ORAL 20120726 OTC MONOGRAPH FINAL part331 Preferred Pharmaceuticals, Inc. MAGNESIUM HYDROXIDE 1200 mg/15mL 68788-9772_af34793c-3492-4b25-b33e-a27f7e20ebdb 68788-9772 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20120727 ANDA ANDA074164 Preferred Pharmaceuticals, Inc. MICONAZOLE NITRATE 20 mg/g 68788-9773_ad232149-329c-4f3d-b1c9-b34975a428fb 68788-9773 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride SOLUTION ORAL 20120727 ANDA ANDA074352 Preferred Pharmaceuticals, Inc. LOPERAMIDE HYDROCHLORIDE 1 mg/5mL 68788-9774_3e1cfe73-1d7f-4807-a26d-0d4c2b4894d9 68788-9774 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine Lidocaine and Prilocaine CREAM TOPICAL 20120726 ANDA ANDA076290 Preferred Pharmaceuticals, Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] 68788-9775_c9009b9a-71b7-4956-a1d2-98adc2457c2b 68788-9775 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20120725 ANDA ANDA075693 Preferred Pharmaceuticals, Inc. IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 68788-9776_84065605-11a6-465c-a86c-ce0d7829091c 68788-9776 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride HydrOXYzine Hydrochloride SOLUTION ORAL 20120727 ANDA ANDA040010 Preferred Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 68788-9777_101da703-5159-4d99-99dc-7d56cb0d28f2 68788-9777 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20120727 ANDA ANDA079237 Preferred Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68788-9778_9283b506-5444-43ed-bb84-11efe2e3015a 68788-9778 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20120725 ANDA ANDA078010 Preferred Pharmaceuticals, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 68788-9779_8147caca-8c23-464b-a3ec-b549e9880684 68788-9779 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20120727 ANDA ANDA075786 Preferred Pharmaceuticals, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68788-9780_ed194106-cb01-4a7b-87a2-64bcaac231e5 68788-9780 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate GEL TOPICAL 20120727 ANDA ANDA064160 Preferred Pharmaceuticals, Inc. CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 68788-9781_bed65850-a169-461e-9bea-1aea88cad038 68788-9781 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20120727 ANDA ANDA075584 Preferred Pharmaceuticals,Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] 68788-9782_53176c67-ebcd-4b07-a08a-f2df3c541af9 68788-9782 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20120727 ANDA ANDA074543 Preferred Pharmaceuticals, Inc. ALBUTEROL SULFATE 5 mg/mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 68788-9783_bdee576a-24bf-41a0-b948-e4c8a33cc8d0 68788-9783 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir SUSPENSION ORAL 20120727 ANDA ANDA074738 Preferred Pharmaceuticals, Inc. ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 68788-9784_e83c14c4-de23-47f1-b4d3-b6b2760b76cf 68788-9784 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120717 NDA NDA022370 Preferred Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 68788-9785_2ddfb83f-73ef-4ccb-b537-2438f6a828d1 68788-9785 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA076273 Preferred Pharmaceuticals, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] 68788-9786_89d4ca14-b58c-43b0-8cf7-617b0c09ebce 68788-9786 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120604 ANDA ANDA065271 Preferred Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 68788-9787_2a77cd73-05f2-40be-b0b8-37b4c2b7eb82 68788-9787 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120604 ANDA ANDA075910 Preferred Pharmaceuticals, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9789_4df20000-01dd-4a82-b5d5-0177d8b219fd 68788-9789 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20120604 ANDA ANDA077614 Preferred Pharmaceuticals,Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 68788-9790_af1249b0-e889-4f02-bdc2-54862de0545e 68788-9790 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120604 ANDA ANDA078906 Preferred Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 68788-9791_9c1743c8-2c87-4a86-84de-306739754603 68788-9791 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20120430 ANDA ANDA073449 Preferred Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68788-9792_9c1743c8-2c87-4a86-84de-306739754603 68788-9792 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20120430 ANDA ANDA071851 Preferred Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 50; 75 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68788-9793_6e55081c-2531-43a2-9c9c-a56ea72e0e16 68788-9793 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20120430 NDA NDA019129 Preferred Pharmaceuticals, Inc HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68788-9794_b84d8603-9f8d-47c9-bb3c-be0834e821fe 68788-9794 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20120430 OTC MONOGRAPH FINAL part333B Preferred Pharmaceuticals, Inc BACITRACIN 500 [USP'U]/g 68788-9795_3defb1a7-01f9-4996-a7bf-29850287f7b4 68788-9795 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20120430 ANDA ANDA090035 Preferred Pharmaceuticals, Inc. FOLIC ACID 1 mg/1 68788-9796_5a2e876c-1255-47e3-90f9-7e3c8bc97114 68788-9796 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20120430 ANDA ANDA077156 Preferred Pharmaceuticals, Inc BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 68788-9797_f7556a21-b0de-4757-bab1-d30950a35c02 68788-9797 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20120508 ANDA ANDA078722 Preferred Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68788-9798_a3735b57-ecc7-43e2-859a-c43e2502779b 68788-9798 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan TABLET ORAL 20120604 ANDA ANDA076554 Preferred Pharmaceuticals, Inc. SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 68788-9799_17473441-f4fa-4fa7-8c56-771cbe544b52 68788-9799 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 20120430 ANDA ANDA040014 Preferred Pharmaceuticals, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 68788-9800_e207eed9-db55-4f03-8305-ff9f01d48ccd 68788-9800 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20120430 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc. HYDROCORTISONE 1 g/100g 68788-9801_d0ce87b8-d484-4307-95a9-05705a6caf85 68788-9801 HUMAN OTC DRUG Emetrol Cherry phosphorated carbohydrate SOLUTION ORAL 20120423 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc PHOSPHORIC ACID; SUCROSE 21.5; 3.74 mg/5mL; g/5mL 68788-9802_fdf78605-1d20-4edd-8864-35ca3e07fc79 68788-9802 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate OINTMENT TOPICAL 20120423 ANDA ANDA074248 Preferred Pharmaceuticals, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9803_0f0610c5-8b27-4aed-8473-8498e97dd54c 68788-9803 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 20120423 ANDA ANDA074249 Preferred Pharmaceuticals, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9804_7c48d641-23ee-456d-9eac-e093aa33ae04 68788-9804 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20120423 ANDA ANDA078930 Preferred Pharmaceuticals, Inc BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9805_366e4040-638d-49cb-b569-c8f2ac2552e0 68788-9805 HUMAN OTC DRUG Loratadine Loratadine SOLUTION ORAL 20120509 ANDA ANDA077421 Preferred Pharmaceuticals, Inc LORATADINE 5 mg/5mL 68788-9807_5aa18b0b-4688-493a-a5ae-cb056ea6c0e3 68788-9807 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20120423 ANDA ANDA077912 Preferred Pharmaceuticals, Inc HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68788-9808_5aa18b0b-4688-493a-a5ae-cb056ea6c0e3 68788-9808 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20120423 ANDA ANDA077912 Preferred Pharmaceuticals, Inc HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68788-9809_5aa18b0b-4688-493a-a5ae-cb056ea6c0e3 68788-9809 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20120423 ANDA ANDA077912 Preferred Pharmaceuticals, Inc HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68788-9810_72923be6-d49c-4ea9-8e20-f9beec10b86e 68788-9810 HUMAN OTC DRUG Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20120423 ANDA ANDA074937 Preferred Pharmaceuticals, Inc IBUPROFEN 100 mg/5mL 68788-9811_149065ec-0c18-43e7-89de-6540bf48207b 68788-9811 HUMAN OTC DRUG TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sulfate OINTMENT TOPICAL 20120425 OTC MONOGRAPH FINAL part333B Preferred Pharmaceuticals, Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 68788-9812_b387be7e-e619-46b5-a7cc-2fcc0484e30a 68788-9812 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, CHEWABLE ORAL 20120423 ANDA ANDA075687 Preferred Pharmaceuticals, Inc CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 68788-9813_1b0ea019-4a51-4eb4-a22e-379785a1b84c 68788-9813 HUMAN OTC DRUG good sense tussin cf cough and cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20120405 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 68788-9814_6016e546-6c02-4af0-888c-c0899865c5f0 68788-9814 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20120405 ANDA ANDA077511 Preferred Pharmaceuticals, Inc TERBINAFINE HYDROCHLORIDE 1 g/100g 68788-9815_9d8fd052-b478-447e-a884-74fcd21275bb 68788-9815 HUMAN PRESCRIPTION DRUG Terazosin hydrochloride Terazosin hydrochloride CAPSULE ORAL 20120405 ANDA ANDA075317 Preferred Pharmaceuticals, Inc TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68788-9816_9d8fd052-b478-447e-a884-74fcd21275bb 68788-9816 HUMAN PRESCRIPTION DRUG Terazosin hydrochloride Terazosin hydrochloride CAPSULE ORAL 20120405 ANDA ANDA075317 Preferred Pharmaceuticals, Inc TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68788-9817_9d8fd052-b478-447e-a884-74fcd21275bb 68788-9817 HUMAN PRESCRIPTION DRUG Terazosin hydrochloride Terazosin hydrochloride CAPSULE ORAL 20120405 ANDA ANDA075317 Preferred Pharmaceuticals, Inc TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 68788-9818_62016bd1-2502-4bca-8274-2caa24fc0c06 68788-9818 HUMAN PRESCRIPTION DRUG Thermazene Silver Sulfadiazine CREAM TOPICAL 20120405 NDA NDA018810 Preferred Pharmaceuticals, Inc SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 68788-9819_5f0ca173-a6af-4deb-87d5-86b5313a4c8e 68788-9819 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 20120405 ANDA ANDA040120 Preferred Pharmaceuticals, Inc PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 68788-9820_394ee5cc-9b4c-42eb-b519-08931a1a8c39 68788-9820 HUMAN PRESCRIPTION DRUG POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate SOLUTION/ DROPS OPHTHALMIC 20120405 NDA AUTHORIZED GENERIC NDA050567 Preferred Pharmaceuticals, Inc POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 68788-9821_631825ef-67f4-473a-a2b8-90cb3edfc4df 68788-9821 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20120405 ANDA ANDA078402 Preferred Pharmaceuticals, Inc LISINOPRIL 40 mg/1 68788-9822_631825ef-67f4-473a-a2b8-90cb3edfc4df 68788-9822 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20120405 ANDA ANDA078402 Preferred Pharmaceuticals, Inc LISINOPRIL 20 mg/1 68788-9823_631825ef-67f4-473a-a2b8-90cb3edfc4df 68788-9823 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20120405 ANDA ANDA078402 Preferred Pharmaceuticals, Inc LISINOPRIL 10 mg/1 68788-9826_70aa7ff2-5780-4ffb-890f-8c862f535541 68788-9826 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20120405 ANDA ANDA071601 Preferred Pharmaceuticals, Inc DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 68788-9827_1761f780-df31-4b10-8b2a-539e0af0ecfd 68788-9827 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20120405 ANDA ANDA040682 Preferred Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 68788-9828_774e51bc-53bc-448c-b6af-4a9a07356125 68788-9828 HUMAN OTC DRUG Analgesic Balm Menthol and Methyl Salicylate OINTMENT ENTERAL 20120405 20150531 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc MENTHOL; METHYL SALICYLATE 6; 14 g/100g; g/100g 68788-9831_7a072f02-05ac-4ce0-8fa4-04a2ad8986fb 68788-9831 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20120604 NDA NDA018877 Preferred Pharmaceuticals, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 68788-9832_ed5e565c-cf5a-4236-ba5b-fb4c4fc79704 68788-9832 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20120604 ANDA ANDA090637 Preferred Pharmaceuticals, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 68788-9833_e3d00b1d-0c68-44cc-ab5b-d76547283090 68788-9833 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin CREAM TOPICAL 20120329 ANDA ANDA075213 Preferred Pharmaceuticals, Inc TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 68788-9834_e3d00b1d-0c68-44cc-ab5b-d76547283090 68788-9834 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin CREAM TOPICAL 20120329 ANDA ANDA075265 Preferred Pharmaceuticals, Inc TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 68788-9835_9cc664c2-873e-440a-bb6d-a2dcef62165d 68788-9835 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20120329 ANDA ANDA077752 Preferred Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-9836_9cc664c2-873e-440a-bb6d-a2dcef62165d 68788-9836 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20120329 ANDA ANDA077752 Preferred Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-9837_8273f9b4-828d-46b3-9bee-8928dbbd6eb7 68788-9837 HUMAN OTC DRUG Childrens QPAP acetaminophen SOLUTION ORAL 20120329 OTC MONOGRAPH NOT FINAL part343 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN 160 mg/5mL 68788-9838_b616ab13-ff66-420a-8ee2-3a6351b51d06 68788-9838 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20120329 ANDA ANDA090618 Preferred Pharmaceuticals, Inc NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68788-9839_aa13aa41-720c-46e3-bf95-34fff5048581 68788-9839 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20120329 ANDA ANDA076045 Preferred Pharmaceuticals, Inc LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9840_aa13aa41-720c-46e3-bf95-34fff5048581 68788-9840 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20120329 ANDA ANDA076045 Preferred Pharmaceuticals, Inc LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9841_17cb3dd4-210c-457b-ba5f-806d50fae513 68788-9841 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate clindamycin phosphate CREAM VAGINAL 20120329 ANDA ANDA065139 Preferred Pharmaceuticals, Inc. CLINDAMYCIN PHOSPHATE 20 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 68788-9842_e5bcfb42-db9c-4fd7-a9c0-aba287f821ab 68788-9842 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Preferred Pharmaceuticals, Inc. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68788-9843_e5bcfb42-db9c-4fd7-a9c0-aba287f821ab 68788-9843 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20120329 ANDA ANDA074505 Preferred Pharmaceuticals, Inc. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68788-9844_a339af11-bf0a-4fe1-9bd5-5d57e273fcd5 68788-9844 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20120329 ANDA ANDA075022 Preferred Pharmaceuticals, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 68788-9845_a339af11-bf0a-4fe1-9bd5-5d57e273fcd5 68788-9845 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20120329 ANDA ANDA075022 Preferred Pharmaceuticals, Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 68788-9846_9073ac12-54a1-4a07-b904-e6af94c909ed 68788-9846 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20120328 ANDA ANDA072234 Preferred Pharmaceuticals, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 68788-9847_7c225e94-28bf-4d0e-ba98-c596c34407c7 68788-9847 HUMAN PRESCRIPTION DRUG AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin and clavulanate potassium POWDER ORAL 20120330 NDA NDA050755 Preferred Pharmaceuticals, Inc AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 68788-9848_4b52b62b-c2a9-4d35-b7f0-ced920793a3f 68788-9848 HUMAN PRESCRIPTION DRUG Econazole Nitrate Econazole Nitrate CREAM TOPICAL 20120329 ANDA ANDA076005 Preferred Pharmaceuticals, Inc. ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 68788-9849_e733babc-7065-4cbf-ab6a-df19c3d8af63 68788-9849 HUMAN OTC DRUG GAVILAX Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20120329 ANDA ANDA091077 Preferred Pharmaceuticals, Inc. POLYETHYLENE GLYCOL 3350 17 g/17g 68788-9852_0fadc788-fdd8-4bfe-b518-e5892a553615 68788-9852 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 20120314 ANDA ANDA060456 Preferred Pharmaceuticals, Inc PENICILLIN V POTASSIUM 250 mg/5mL 68788-9853_0fadc788-fdd8-4bfe-b518-e5892a553615 68788-9853 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 20120314 ANDA ANDA060456 Preferred Pharmaceuticals, Inc PENICILLIN V POTASSIUM 125 mg/5mL 68788-9854_e6204fc5-f198-4afe-bbcd-45ae2ab5297d 68788-9854 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20120329 ANDA ANDA065435 Preferred Pharmaceuticals, Inc PENICILLIN V POTASSIUM 500 mg/1 68788-9855_e14a98fd-3b83-46dc-a5e0-17cd55dcafa1 68788-9855 HUMAN OTC DRUG Medrox METHYL SALICYLATE, MENTHOL, CAPSAICIN OINTMENT TOPICAL 20120312 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc CAPSAICIN; MENTHOL; METHYL SALICYLATE .0375; 5; 20 g/100g; g/100g; g/100g 68788-9856_56772747-1078-44a8-8afd-3568279ce331 68788-9856 HUMAN OTC DRUG Hydrocortisone hydrocortisone CREAM TOPICAL 20120312 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc HYDROCORTISONE 10 mg/g 68788-9857_bd2f5cb0-b1eb-4964-8a07-538088a7a889 68788-9857 HUMAN OTC DRUG Docuprene DOCUSATE SODIUM TABLET ORAL 20120312 OTC MONOGRAPH NOT FINAL part334 Preferred Pharmaceuticals, Inc DOCUSATE SODIUM 100 mg/1 68788-9858_95cd5442-e62d-4dee-9da3-d8b6868dfe68 68788-9858 HUMAN OTC DRUG Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20120313 OTC MONOGRAPH FINAL part349 Preferred Pharmaceuticals, Inc POLYVINYL ALCOHOL 14 mg/mL 68788-9859_e6ab3ac4-e84b-42f0-9f98-ae39a0c35616 68788-9859 HUMAN PRESCRIPTION DRUG ANUCORT-HC Hydrocortisone Acetate SUPPOSITORY RECTAL 20120312 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9860_b9df7953-db50-4c87-b60f-cc61c7be4bf5 68788-9860 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20120228 ANDA ANDA071524 Preferred Pharmaceuticals, Inc TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 68788-9861_b9df7953-db50-4c87-b60f-cc61c7be4bf5 68788-9861 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20120228 ANDA ANDA071523 Preferred Pharmaceuticals, Inc TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 68788-9864_73099108-cee2-4c3d-8b9a-f66cb9795b30 68788-9864 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20120228 ANDA ANDA071457 Preferred Pharmaceuticals, Inc TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9865_73099108-cee2-4c3d-8b9a-f66cb9795b30 68788-9865 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20120228 ANDA ANDA071456 Preferred Pharmaceuticals, Inc TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9868_e507e3f6-6690-4c93-922d-2b665cd23225 68788-9868 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20120228 ANDA ANDA078155 Preferred Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-9869_e507e3f6-6690-4c93-922d-2b665cd23225 68788-9869 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20120228 ANDA ANDA078155 Preferred Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 68788-9870_f25741dd-a1d5-43fd-a21f-746d53f97c24 68788-9870 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 20120228 ANDA ANDA064052 Preferred Pharmaceuticals, Inc TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 68788-9871_cf0cc763-49b5-435d-852b-e7617c8d3286 68788-9871 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium sulfacetamide sodium SOLUTION/ DROPS OPHTHALMIC 20120228 ANDA ANDA040066 Preferred Pharmaceuticals, Inc SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 68788-9872_c300ee1d-c1c5-442b-85d2-01a8a13e1935 68788-9872 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20120227 ANDA ANDA077397 Preferred Pharmaceuticals, Inc SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9873_c300ee1d-c1c5-442b-85d2-01a8a13e1935 68788-9873 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20120227 ANDA ANDA077397 Preferred Pharmaceuticals, Inc SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68788-9874_1d6b4ff2-eb02-419a-8d82-75e42780514a 68788-9874 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20120227 ANDA ANDA077824 Preferred Pharmaceuticals, Inc RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68788-9875_1d6b4ff2-eb02-419a-8d82-75e42780514a 68788-9875 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20120227 ANDA ANDA077824 Preferred Pharmaceuticals, Inc RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 68788-9876_90fba723-51b1-4404-a30b-816f35001d91 68788-9876 HUMAN PRESCRIPTION DRUG PRED MILD prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 20120305 NDA NDA017100 Preferred Pharmaceuticals, Inc PREDNISOLONE ACETATE 1.2 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9877_e062f22c-b3e3-4f7e-8701-fbe9cbd47be8 68788-9877 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120305 ANDA ANDA040525 Preferred Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 68788-9879_79f0ef18-6c56-41d2-83c9-f358c23ccd80 68788-9879 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20120305 ANDA ANDA074132 Preferred Pharmaceuticals, Inc NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 68788-9880_79f0ef18-6c56-41d2-83c9-f358c23ccd80 68788-9880 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20120305 ANDA ANDA074132 Preferred Pharmaceuticals, Inc NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 68788-9881_a92bf444-0ae7-4365-831e-9fd37d59d5fa 68788-9881 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20120312 ANDA ANDA074661 Preferred Pharmaceuticals, Inc NAPROXEN SODIUM 220 mg/1 68788-9882_8e467d61-e26f-410e-b582-465432f087c1 68788-9882 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin and Polymyxin B Sulfates and Dexamethasone OINTMENT OPHTHALMIC 20120402 NDA AUTHORIZED GENERIC NDA050065 Preferred Pharmaceuticals, Inc DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [iU]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9883_dec1337a-0ff1-44c0-9f7c-7e5ef18d6fbd 68788-9883 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide CREAM TOPICAL 20120214 ANDA ANDA040671 Preferred Pharmaceuticals, Inc TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9884_03dc63f5-78cc-495a-a80b-fb77aeed8815 68788-9884 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20120214 ANDA ANDA075855 Preferred Pharmaceuticals, Inc OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9885_8818fc86-56a3-44d3-8347-8ef48e71ad84 68788-9885 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120214 ANDA ANDA090649 Preferred Pharmaceuticals, Inc NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68788-9886_8818fc86-56a3-44d3-8347-8ef48e71ad84 68788-9886 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120214 ANDA ANDA090649 Preferred Pharmaceuticals, Inc NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 68788-9887_918f50d4-5468-400e-b51f-72ac883af46e 68788-9887 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole GEL VAGINAL 20120214 NDA AUTHORIZED GENERIC NDA020208 Preferred Pharmaceuticals, Inc METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 68788-9888_4a38f753-a2bf-40af-b638-00c3e409fb98 68788-9888 HUMAN PRESCRIPTION DRUG Next Choice levonorgestrel TABLET ORAL 20120214 ANDA ANDA078665 Preferred Pharmaceuticals, Inc LEVONORGESTREL .75 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] 68788-9889_d62307f8-7110-410d-b4fb-80572b547b9c 68788-9889 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20120214 ANDA ANDA074644 Preferred Pharmaceuticals, Inc METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68788-9890_d62307f8-7110-410d-b4fb-80572b547b9c 68788-9890 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20120214 ANDA ANDA074644 Preferred Pharmaceuticals, Inc METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 68788-9891_6d1a2c50-5e9f-49f4-a304-884cb87d9284 68788-9891 HUMAN PRESCRIPTION DRUG mupirocin Mupirocin OINTMENT TOPICAL 20120214 ANDA ANDA065123 Preferred Pharmaceuticals, Inc MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] 68788-9892_6e6543df-d371-4103-a08c-9b12e4c6ec22 68788-9892 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET ORAL 20120214 ANDA ANDA077851 Preferred Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68788-9893_6e6543df-d371-4103-a08c-9b12e4c6ec22 68788-9893 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET ORAL 20120214 ANDA ANDA077851 Preferred Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68788-9894_7c45c2a6-0565-44e6-b538-a15a1bf72007 68788-9894 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20120214 ANDA ANDA077557 Preferred Pharmaceuticals, Inc ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 68788-9895_05ee5bda-6c95-4ee8-ba95-7485603eae93 68788-9895 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20120214 ANDA ANDA040650 Preferred Pharmaceuticals, Inc CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV 68788-9896_5c489585-7839-4701-8b26-bb84f0e970c1 68788-9896 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20120214 NDA NDA013217 Preferred Pharmaceuticals, Inc METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 68788-9897_2db605f1-e52b-4fc1-8695-1399e1a73f27 68788-9897 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20120214 ANDA ANDA077921 Preferred Pharmaceuticals, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9898_2db605f1-e52b-4fc1-8695-1399e1a73f27 68788-9898 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20120214 ANDA ANDA077921 Preferred Pharmaceuticals, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9899_37275fd0-eb24-40a4-a93f-b818bb98414e 68788-9899 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 20120213 ANDA ANDA040159 Preferred Pharmaceuticals, Inc MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 68788-9900_7bdda27b-e123-4f33-87e2-63f33b2b061e 68788-9900 HUMAN PRESCRIPTION DRUG PROAIR HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20120213 NDA NDA021457 Preferred Pharmaceuticals, Inc ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 68788-9901_c137c163-4e17-414b-a443-fff56ffe530c 68788-9901 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20120213 ANDA ANDA040197 Preferred Pharmaceuticals, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 68788-9902_d35cfb88-c1e8-4b7e-b223-3b43ee8701f6 68788-9902 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 20120130 ANDA ANDA074220 Preferred Pharmaceuticals, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9903_2c0d33bb-f4bb-4331-a640-10fc802ef3fd 68788-9903 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole SHAMPOO, SUSPENSION TOPICAL 20120130 ANDA ANDA076419 Preferred Pharmaceuticals, Inc. KETOCONAZOLE 20 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68788-9904_d726af1c-277c-45fe-90c3-098477cadb32 68788-9904 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20120130 ANDA ANDA078616 Preferred Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 68788-9905_d726af1c-277c-45fe-90c3-098477cadb32 68788-9905 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20120130 ANDA ANDA078616 Preferred Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 68788-9906_6d757241-53f8-4498-999a-87dfe3cb4d17 68788-9906 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20120130 ANDA ANDA075927 Preferred Pharmaceuticals, Inc NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9907_6d757241-53f8-4498-999a-87dfe3cb4d17 68788-9907 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20120130 ANDA ANDA075927 Preferred Pharmaceuticals, Inc NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9908_f907e0cb-7e1b-43ec-a11b-ea0b3737683c 68788-9908 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20120130 ANDA ANDA078671 Preferred Pharmaceuticals, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9909_f907e0cb-7e1b-43ec-a11b-ea0b3737683c 68788-9909 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20120130 ANDA ANDA078671 Preferred Pharmaceuticals, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9910_8adb81e9-2ada-47be-bac8-990f25db9bf2 68788-9910 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20120130 ANDA ANDA076063 Preferred Pharmaceuticals, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68788-9911_8adb81e9-2ada-47be-bac8-990f25db9bf2 68788-9911 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20120130 ANDA ANDA076063 Preferred Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68788-9912_8adb81e9-2ada-47be-bac8-990f25db9bf2 68788-9912 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20120130 ANDA ANDA076063 Preferred Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 68788-9915_899a9cb9-09b2-4e16-baa3-058eaab04739 68788-9915 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20120130 ANDA ANDA075638 Preferred Pharmaceuticals, Inc KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 68788-9916_ebcc0570-4a54-4f10-be90-da603ccf96d4 68788-9916 HUMAN PRESCRIPTION DRUG Hydroquinone with sunscreens HYDROQUINONE, DIOXYBENZONE, OXYBENZONE, PADIMATE O CREAM TOPICAL 20120130 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc DIOXYBENZONE; HYDROQUINONE; OXYBENZONE; PADIMATE O 30; 40; 20; 80 mg/g; mg/g; mg/g; mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 68788-9917_26d86098-6514-4fdf-96bd-04fde1d50c1e 68788-9917 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20120130 ANDA ANDA077537 Preferred Pharmaceuticals, Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68788-9918_3ee49946-db65-4667-bd5d-92b112e9ed02 68788-9918 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20120130 ANDA ANDA074305 Preferred Pharmaceuticals, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 68788-9919_de3ae961-8ed1-4192-bfa2-2819e9fc732c 68788-9919 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20120130 ANDA ANDA040412 Preferred Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68788-9920_de3ae961-8ed1-4192-bfa2-2819e9fc732c 68788-9920 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20120130 ANDA ANDA040412 Preferred Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68788-9921_df6fcd1e-8bb8-4004-b941-4c8d973907bf 68788-9921 HUMAN PRESCRIPTION DRUG GENTAMICIN SULFATE gentamicin sulfate SOLUTION/ DROPS OPHTHALMIC 20140325 ANDA ANDA062452 Preferred Pharmaceuticals, Inc. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] 68788-9922_0baded3b-3b24-449e-b920-03dfbfc52ea2 68788-9922 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20120127 ANDA ANDA085025 Preferred Pharmaceuticals, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9923_d4c367ce-718b-42c7-8220-f21ced523a29 68788-9923 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20120127 ANDA ANDA200651 Preferred Pharmaceuticals, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 68788-9924_8776131f-ada3-4262-ac18-6143dd394d2c 68788-9924 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 20120118 ANDA ANDA064065 Preferred Pharmaceuticals, Inc. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] 68788-9925_3e710670-b72c-4a84-8c52-3ebae8783a32 68788-9925 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20120118 ANDA ANDA077570 Preferred Pharmaceuticals, Inc FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9926_693e1c9f-9260-4e85-9932-4ef7ee6def00 68788-9926 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20120118 ANDA ANDA076077 Preferred Pharmaceuticals, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68788-9927_693e1c9f-9260-4e85-9932-4ef7ee6def00 68788-9927 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20120118 ANDA ANDA076077 Preferred Pharmaceuticals, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] 68788-9928_05b00849-d8e3-4855-badf-18d8ebbebec9 68788-9928 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20120118 ANDA ANDA075009 Preferred Pharmaceuticals, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9929_384af51f-6f1b-4c76-9ded-d948652c9c34 68788-9929 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20120117 ANDA ANDA075074 Preferred Pharmaceuticals, Inc ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9930_384af51f-6f1b-4c76-9ded-d948652c9c34 68788-9930 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20120117 ANDA ANDA075078 Preferred Pharmaceuticals, Inc ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 68788-9931_fb88c505-580e-4e91-86a2-24b3bb8c6a24 68788-9931 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20120117 ANDA ANDA075483 Preferred Pharmaceuticals, Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68788-9932_fb88c505-580e-4e91-86a2-24b3bb8c6a24 68788-9932 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20120117 ANDA ANDA075483 Preferred Pharmaceuticals, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68788-9933_fb88c505-580e-4e91-86a2-24b3bb8c6a24 68788-9933 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20120117 ANDA ANDA075483 Preferred Pharmaceuticals, Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68788-9934_95daf8b8-77ee-40cd-9918-3f650317e669 68788-9934 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 Preferred Pharmaceuticals, Inc DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 68788-9935_e6ed8f98-559e-415a-9331-a6696c18a159 68788-9935 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 20120117 ANDA ANDA040204 Preferred Pharmaceuticals, Inc DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 68788-9936_3e02d0e0-e7e0-45e4-8d9d-c4d3925519ad 68788-9936 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20120117 ANDA ANDA077749 Preferred Pharmaceuticals, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9937_3e02d0e0-e7e0-45e4-8d9d-c4d3925519ad 68788-9937 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20120117 ANDA ANDA077749 Preferred Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9938_d37a2991-c74b-40ef-870c-d783d06ea073 68788-9938 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 20120117 ANDA ANDA088238 Preferred Pharmaceuticals, Inc. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9939_d37a2991-c74b-40ef-870c-d783d06ea073 68788-9939 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 20120117 ANDA ANDA088160 Preferred Pharmaceuticals, Inc. DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68788-9940_897c2304-9197-4efc-a4f9-3842094a7fd6 68788-9940 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20120117 ANDA ANDA074869 Preferred Pharmaceuticals, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9941_897c2304-9197-4efc-a4f9-3842094a7fd6 68788-9941 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20120117 ANDA ANDA074869 Preferred Pharmaceuticals, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9942_599cf74f-58d8-4d1f-ad84-5a6cf170993c 68788-9942 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20120116 ANDA ANDA065061 Preferred Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 68788-9943_599cf74f-58d8-4d1f-ad84-5a6cf170993c 68788-9943 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20120116 ANDA ANDA065061 Preferred Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] 68788-9944_98d8e8b5-13ae-48ab-b408-5dc5008d3811 68788-9944 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20120112 ANDA ANDA076673 Preferred Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 68788-9945_fe9e9710-e1c9-4d58-bee1-f48383ee8276 68788-9945 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20120112 ANDA ANDA076402 Preferred Pharmaceuticals, Inc BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68788-9946_fe9e9710-e1c9-4d58-bee1-f48383ee8276 68788-9946 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20120112 ANDA ANDA076402 Preferred Pharmaceuticals, Inc BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68788-9947_fe9e9710-e1c9-4d58-bee1-f48383ee8276 68788-9947 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20120112 ANDA ANDA076402 Preferred Pharmaceuticals, Inc BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] 68788-9948_fc2b070c-4bb5-4279-83c0-c242d0b44563 68788-9948 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20120112 ANDA ANDA065387 Preferred Pharmaceuticals, Inc. AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 68788-9949_fc2b070c-4bb5-4279-83c0-c242d0b44563 68788-9949 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20120112 ANDA ANDA065387 Preferred Pharmaceuticals, Inc. AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 68788-9950_dbb85c63-f85d-443e-ba5b-640bb398c849 68788-9950 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120305 ANDA ANDA065248 Preferred Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68788-9951_dbb85c63-f85d-443e-ba5b-640bb398c849 68788-9951 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120305 ANDA ANDA065248 Preferred Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68788-9952_39192971-a732-4d14-a055-51ed39ff951d 68788-9952 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20120112 ANDA ANDA078491 Preferred Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9953_39192971-a732-4d14-a055-51ed39ff951d 68788-9953 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20120112 ANDA ANDA078491 Preferred Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9954_39192971-a732-4d14-a055-51ed39ff951d 68788-9954 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20120112 ANDA ANDA078491 Preferred Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 68788-9955_4565de36-b28b-43b6-ac5a-de2ee9c05cd2 68788-9955 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20120110 ANDA ANDA076048 Preferred Pharmaceuticals, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 68788-9956_620e84c3-4761-42d2-8ec4-8e06186eb780 68788-9956 HUMAN PRESCRIPTION DRUG cephalexin Cephalexin FOR SUSPENSION ORAL 20120110 ANDA ANDA065234 Preferred Pharmaceuticals, Inc. CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68788-9957_620e84c3-4761-42d2-8ec4-8e06186eb780 68788-9957 HUMAN PRESCRIPTION DRUG cephalexin Cephalexin FOR SUSPENSION ORAL 20120110 ANDA ANDA065234 Preferred Pharmaceuticals, Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 68788-9958_3f0bbf9d-09d4-44ed-8b62-cfb509855e8c 68788-9958 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20120110 ANDA ANDA065246 Preferred Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68788-9959_3f0bbf9d-09d4-44ed-8b62-cfb509855e8c 68788-9959 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20120110 ANDA ANDA065246 Preferred Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] 68788-9960_d9053d25-6250-47de-9a2f-c504b31d9630 68788-9960 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20120109 NDA NDA050564 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 68788-9961_d9053d25-6250-47de-9a2f-c504b31d9630 68788-9961 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20120109 NDA NDA050720 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] 68788-9962_26db00ff-75e8-4113-9ac5-1eb48e1d2541 68788-9962 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION ORAL 20120110 ANDA ANDA078105 Preferred Pharmaceuticals, Inc ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 68788-9979_6119892d-ce34-4b3e-9a3e-3f8a94f3fbca 68788-9979 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20131009 OTC MONOGRAPH FINAL part349 Preferred Pharmaceuticals, Inc. WATER 99.05 mL/100mL 68788-9992_02119f5d-7294-4cf0-9c93-6bc5a53a4ac8 68788-9992 HUMAN OTC DRUG SENNA TIME SENNOSIDES TABLET, COATED ORAL 20130329 OTC MONOGRAPH NOT FINAL part334 Preferred Pharmaceuticals, Inc. SENNOSIDES A AND B 8.6 mg/1 68788-9994_f6f3e978-dd1d-4d5c-bf7d-1fbc9fe05d0b 68788-9994 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060927 ANDA ANDA077912 Preferred Pharmaceuticals, Inc HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 68791-100_d5e3e9d0-a9a9-472a-ae49-54d4eb632ba4 68791-100 HUMAN PRESCRIPTION DRUG pediapred PREDNISOLONE SODIUM PHOSPHATE SOLUTION ORAL 20030326 ANDA ANDA075183 Royal Pharmaceuticals PREDNISOLONE SODIUM PHOSPHATE 5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68791-101_7d77937f-c3a3-49ec-85f0-cbd991c31e66 68791-101 HUMAN PRESCRIPTION DRUG Derma-Smoothe/FS fluocinolone acetonide OIL TOPICAL 19950216 NDA NDA019452 Royal Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68791-102_62936c57-d43b-4d60-b02a-ccf2b85a8963 68791-102 HUMAN PRESCRIPTION DRUG Derma-Smoothe/FS fluocinolone acetonide OIL TOPICAL 19950216 NDA NDA019452 Royal Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68791-103_9039b56d-17da-46ac-bfe4-32d2d20917ea 68791-103 HUMAN PRESCRIPTION DRUG DermOtic fluocinolone acetonide OIL AURICULAR (OTIC) 20051109 NDA NDA019452 Royal Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68796-5626_6dbd157a-7539-4992-9618-f59d7cf61084 68796-5626 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20031001 UNAPPROVED MEDICAL GAS Covenant Home Medical OXYGEN 99 L/100L 68803-612_7b707773-40d8-4896-85db-e96b5fed1a4b 68803-612 HUMAN PRESCRIPTION DRUG VisionBlue Trypan Blue INJECTION, SOLUTION INTRAOCULAR; OPHTHALMIC 20041216 NDA NDA021670 Dutch Ophthalmic Research Center International B.V. TRYPAN BLUE .3 mg/.5mL 68803-672_190d903b-660d-4a2b-8281-9b7961ac50b2 68803-672 HUMAN PRESCRIPTION DRUG MembraneBlue Trypan Blue INJECTION, SOLUTION INTRAOCULAR; OPHTHALMIC 20090220 NDA NDA022278 Dutch Ophthalmic Research Center International B.V. TRYPAN BLUE .75 mg/.5mL 68807-301_34f18c0f-1669-44f9-b200-2bededba9ec5 68807-301 HUMAN PRESCRIPTION DRUG La Prairie Switzerland Cellular Radiance Emulsion Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Temmentec Ag AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 kg/100kg; kg/100kg; kg/100kg 68809-544_839ed82a-ef77-4bad-af8b-c28f86e9d423 68809-544 HUMAN OTC DRUG Heavy Duty Hand Cleaner CHLOROXYLENOL SOAP TOPICAL 20040427 OTC MONOGRAPH NOT FINAL part333E MPI Chemicals, Inc. CHLOROXYLENOL 3 mg/mL 68814-111_e7d16a16-da4c-4510-b314-5d1bfd710b9a 68814-111 HUMAN OTC DRUG Molton Brown Anti-Perspirant Stick Cool Buchu Aluminum Zirconium Tetrachlorohydrex STICK TOPICAL 20100401 OTC MONOGRAPH FINAL part350 Molton Brown Ltd. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 68814-128_bb2c37df-ecd6-483b-b20d-3a13da408485 68814-128 HUMAN OTC DRUG Karanja Tree Sunshield SPF 30 Molton Brown Skin Care Avobenzone, Ensulizole, Octinoxate, Octocrylene CREAM TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part352 Molton Brown LTD AVOBENZONE; ENSULIZOLE; OCTINOXATE; OCTOCRYLENE 3; 3; 7.5; 2 g/100mL; g/100mL; g/100mL; g/100mL 68814-145_887f8a54-2fc9-484b-abd6-31a7a969f645 68814-145 HUMAN OTC DRUG Sport Anti-Perpirant Sportstick Molton Brown London Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130115 OTC MONOGRAPH FINAL part350 Molton Brown LTD (UK) ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 14.4 g/75g 68814-250_e235ef04-0b51-4d82-a518-f1bb2b37236c 68814-250 HUMAN OTC DRUG Skin Firm Lipoamino hydrator SPF 15 Molton Brown Avobenzone, Ensulizole, Octinoxate, Octocrylene LOTION TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 Molton Brown LTD AVOBENZONE; ENSULIZOLE; OCTINOXATE; OCTOCRYLENE 3; 1; 5; 2 g/100mL; g/100mL; g/100mL; g/100mL 68814-489_b2bbfded-289a-436c-b6ea-b9ae3fab215f 68814-489 HUMAN OTC DRUG Re-Charge Black Pepper Antiperspirant Molton Brown Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101123 OTC MONOGRAPH FINAL part350 Molton Brown LTD ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g 68817-134_5836ac7d-ba4a-4f85-bacc-ffcf82bbd5e7 68817-134 HUMAN PRESCRIPTION DRUG ABRAXANE Paclitaxel INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION INTRAVENOUS 20050210 NDA NDA021660 Abraxis BioScience, LLC PACLITAXEL 100 mg/20mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] 68820-105_4b03f280-f14e-4a58-9ebc-c32d56b2848c 68820-105 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120707 ANDA ANDA091123 Orchid Healthcare (a division of Orchid Chemicals & Pharmaceuticals Ltd.) VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68820-106_4b03f280-f14e-4a58-9ebc-c32d56b2848c 68820-106 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120707 ANDA ANDA091123 Orchid Healthcare (a division of Orchid Chemicals & Pharmaceuticals Ltd.) VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68820-107_4b03f280-f14e-4a58-9ebc-c32d56b2848c 68820-107 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120707 ANDA ANDA091123 Orchid Healthcare (a division of Orchid Chemicals & Pharmaceuticals Ltd.) VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68828-046_540c038c-5736-4ce9-a4d6-cda4623d1444 68828-046 HUMAN OTC DRUG OIL CONTROLLING MAKEUP SPF 15 OCTINOXATE OCTISALATE OXYBENZONE LOTION TOPICAL 20120419 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL 68828-047_18abcbd7-0299-4c20-9fd7-317a988b891d 68828-047 HUMAN OTC DRUG SKIN DEFENSE MAKEUP SPF 15 OCTINOXATE OCTISALATE OXYBENZONE LOTION TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL 68828-048_c0aa639c-80e2-4ee9-bdff-20156248716a 68828-048 HUMAN OTC DRUG MOISTURIZING MAKEUP SPF 15 OCTINOXATE OCTISALATE OXYBENZONE LOTION TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL 68828-049_c7e9de04-14d8-4e1b-b480-05711986a194 68828-049 HUMAN OTC DRUG JAFRA PRO FACE LIFT SPF 20 OCTOCRYLENE OCTISALATE HOMOSALATE AVOBENZONE LOTION TOPICAL 20120504 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 7 g/100mL; g/100mL; g/100mL; g/100mL 68828-052_5f535b60-24e3-4113-937e-52a381023a91 68828-052 HUMAN OTC DRUG JAFRA DAILY FLORAL MIST FOR WOMEN ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY LOTION TOPICAL 20120424 OTC MONOGRAPH FINAL part350 JAFRA COSMETICS INTERNATIONAL ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15 g/100g 68828-053_c9b75af0-88ad-4d3c-a1e7-b35345162e40 68828-053 HUMAN OTC DRUG JAFRA DAILY POWDER FRESH FOR WOMEN ALUMINUM CHLOROHYDRATE LOTION TOPICAL 20120424 OTC MONOGRAPH FINAL part350 JAFRA COSMETICS INTERNATIONAL ALUMINUM CHLOROHYDRATE 12.3 g/100g 68828-054_0f9997cc-6ace-4e05-aaa1-c6d659ebb79d 68828-054 HUMAN OTC DRUG FACE PROTECTOR SPF 40 OCTINOXATE OXYBENZONE OCTISALATE OCTOCRYLENE TITANIUM DIOXIDE LOTION TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 5; 2; 2; 2 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 68828-055_9cbcd855-2de2-48c1-b4b7-143d94ba9a6c 68828-055 HUMAN OTC DRUG CALMING DYNAMICS SPF 15 OCTINOXATE OCTISALATE OXYBENZONE CREAM TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 7; 4; 2 g/100mL; g/100mL; g/100mL 68828-057_77df7252-0230-4020-95a8-3616fe7a25e0 68828-057 HUMAN OTC DRUG 2 IN 1 POWDER MAKE-UP SPF 15 OCTINOXATE TITANIUM DIOXIDE POWDER TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 5; 3.25 g/100g; g/100g 68828-059_f908b859-c350-4b06-8e86-cabe83cc1e39 68828-059 HUMAN OTC DRUG Cafe Mocha Always Stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130225 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-060_714465bd-2186-4e99-9fb7-4eb6c509b56e 68828-060 HUMAN OTC DRUG TENDER MOMENTS SPF 45 HOMOSALATE OCTINOXATE OCTISALATE OXYBENZONE TITANIUM DIOXIDE OCTOCRYLENE LOTION TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 10; 7.7; 5; 1.5; 5; 5.5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 68828-061_0176ac8a-911b-4b73-9581-334e92be335a 68828-061 HUMAN OTC DRUG Cashmere Always Stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, TItanium Dioxide LIQUID TOPICAL 20130226 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-062_3c9bb4a7-14c1-45e2-af9c-1b1863093f31 68828-062 HUMAN OTC DRUG Cocoa Always Color Stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130226 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-064_45b4c3c2-a20c-4f94-969b-0c8d1de34dc5 68828-064 HUMAN OTC DRUG Golden Tan Always Stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130227 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-065_d4633a3b-6c9a-4ac8-8db9-497cc48b17c2 68828-065 HUMAN OTC DRUG Ivory Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-066_ec09c2fe-dafe-4c72-a90a-c213ec5bf6b7 68828-066 HUMAN OTC DRUG Natural Tan Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-067_2195dc81-3dec-457c-865c-88c8863c83b9 68828-067 HUMAN OTC DRUG Porcelain Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-068_4d72a003-b164-4d35-be98-a24bf5bca236 68828-068 HUMAN OTC DRUG Quiet Rose Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-069_34e863a4-b18d-4dad-ba6d-4f3d15c24b38 68828-069 HUMAN OTC DRUG Sandy Beige Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-070_1300837e-e4f2-4f28-8074-9a06f5588e2f 68828-070 HUMAN OTC DRUG True Beige Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMethoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-071_1dbb9732-5ece-409b-a4ab-028542664abf 68828-071 HUMAN OTC DRUG Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMethoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-072_dc7c63bb-dc21-4584-bc77-e07dcc78c8c2 68828-072 HUMAN OTC DRUG Beauty Dynamics SPF 15 Daily Eye Treatment Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20120518 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 7.5; 5; 1.75 mL/100mL; mL/100mL; mL/100mL; mL/100mL 68828-074_adae0d15-c992-4680-ae7d-b2e82aec5ae4 68828-074 HUMAN OTC DRUG Jafra Clear Blemish Treatment Salicylic Acid GEL TOPICAL 20120518 OTC MONOGRAPH FINAL part358H JAFRA COSMETICS INTERNATIONAL SALICYLIC ACID 2 mL/100mL 68828-075_40c5674b-eebd-4344-812a-d5047975d827 68828-075 HUMAN OTC DRUG Bisque Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMethoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-076_6225d5ff-50f7-4904-8f02-518247fb3f81 68828-076 HUMAN OTC DRUG Ivory Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-077_1bf948ae-672c-4a0d-9adc-eee79243e000 68828-077 HUMAN OTC DRUG Quiet Rose Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-078_cc31d229-ded0-4bbb-9d41-ff3e32168457 68828-078 HUMAN OTC DRUG Simply Beige Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-079_d777e6f4-29ea-4faf-b499-d1eadb19ba8d 68828-079 HUMAN OTC DRUG Sandy Beige Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-080_17b7a8de-d2cc-4900-8f46-178e3bde97eb 68828-080 HUMAN OTC DRUG Desert Beige Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-081_1cbfa5b0-e74a-441e-9b80-aa6ba0db01c9 68828-081 HUMAN OTC DRUG Cashmere Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-082_ae45ed21-758f-43d8-9015-b30a6cf8835a 68828-082 HUMAN OTC DRUG Toast Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-083_ff2f0eb4-333b-4c4f-8c8f-5e6b00c557df 68828-083 HUMAN OTC DRUG Cafe Au Lait Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-084_ac200ea2-3377-4aae-8528-ed661705327a 68828-084 HUMAN OTC DRUG Warm Ginger Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-085_22dad215-e37c-41aa-896a-91816bb1342e 68828-085 HUMAN OTC DRUG Toffee Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-086_586b21fb-d87e-4846-a302-1e0ab7896e1f 68828-086 HUMAN OTC DRUG Golden Tan Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-087_40337664-4115-4e92-a93b-a81e8f14b248 68828-087 HUMAN OTC DRUG Natural Tan Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-088_8b9a31fd-87d6-453e-b7ec-a9615a22054b 68828-088 HUMAN OTC DRUG Cafe Mocha Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-089_594d6df9-17e2-4a6e-a3a5-43e5f25e7c29 68828-089 HUMAN OTC DRUG Cocoa Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-090_24912ca5-119f-450e-9b78-d49e5a964322 68828-090 HUMAN OTC DRUG Soft Beige Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; 8 mL/100mL; mL/100mL 68828-091_0e9a4398-3df5-4534-8262-2280aae07698 68828-091 HUMAN OTC DRUG Brightening Hand Broad Spectrum SPF 20 Jafra avobenzone, octinoxate, octisalate, octocrylene CREAM TOPICAL 20120530 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 7.5; 5; 7 g/100mL; g/100mL; g/100mL; g/100mL 68828-092_20684ed5-35c3-4aaf-a2a5-1be32741fc6b 68828-092 HUMAN OTC DRUG Face and Body Sunscreen Spray SPF 35 Homosalate, Oxybenzone, Octinoxate, Octisalate, Octocrylene LOTION TOPICAL 20120605 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 10; 3; 5; 2.79; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 68828-093_f91b8df2-4121-44f0-9d79-221964a725ba 68828-093 HUMAN OTC DRUG Three step hand care Day Care SPF 15 Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 2 mL/100mL; mL/100mL; mL/100mL 68828-094_da9804f0-f5ec-4678-85ac-7a6d3c2811b7 68828-094 HUMAN OTC DRUG Sunscreen SPF 30 Jafra Sun Homosalate, Octisalate, Octocrylene, Oxybenzone, Avobenzone CREAM TOPICAL 20120531 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.79; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 68828-095_bb2d966a-0438-4027-85c2-e2df71a16dc8 68828-095 HUMAN OTC DRUG Tender Moments Baby Bottom Balm Zinc Oxide, Dimethicone CREAM TOPICAL 20120607 OTC MONOGRAPH NOT FINAL part347 JAFRA COSMETICS INTERNATIONAL DIMETHICONE; ZINC OXIDE 2; 10 mL/100mL; mL/100mL 68828-096_2a61837c-f8dd-45a2-88d1-6e420eabe96e 68828-096 HUMAN OTC DRUG Foaming Cleanser Jafra Salicylic Acid GEL TOPICAL 20120515 OTC MONOGRAPH FINAL part333D JAFRA COSMETICS INTERNATIONAL SALICYLIC ACID .5 g/100mL 68828-097_24878110-604c-4327-9ede-40e16eedcd9a 68828-097 HUMAN OTC DRUG Protector SPF 15 Jafra Sun Avobenzone, Homosalate, Octisalate, Oxybenzone STICK TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 2.5; 7.5; 2; 5 g/100g; g/100g; g/100g; g/100g 68828-098_bf3b0d26-ca18-4563-821b-86c469f5c24b 68828-098 HUMAN OTC DRUG Time Dynamics Time Protector Daily Defense SPF 15 Octinoxate, Zinc Oxide CREAM, AUGMENTED TOPICAL 20120530 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; ZINC OXIDE 3.75; 1.5 mL/50mL; mL/50mL 68828-100_4f655bf0-349f-4783-ade0-5b88120654f6 68828-100 HUMAN OTC DRUG Men Dynamics Double Duty Face Protector SPF 15 Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20120530 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 5.625; 3.75; 1.5 mL/75mL; mL/75mL; mL/75mL 68828-101_d39adcf6-9f3d-42a9-907b-c89de9cebd39 68828-101 HUMAN OTC DRUG Jafra Brightening Brightening SPF 15 Otinoxate, Zinc Oxide LOTION TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; ZINC OXIDE 2.5; 2 mL/50mL; mL/50mL 68828-102_761c3301-a69f-4521-9aa2-555a9e567ed1 68828-102 HUMAN OTC DRUG Mattifying Tonic Jafra Salicylic Acid LIQUID TOPICAL 20120619 OTC MONOGRAPH FINAL part333D JAFRA COSMETICS INTERNATIONAL SALICYLIC ACID .5 g/100mL 68828-103_08e90f7b-714b-4cdb-a88e-0bf886af1bf3 68828-103 HUMAN OTC DRUG Active Sport Family Sunscreen SPF 35 Octinoxate, Octisalate, Avobenzone, Octocrylene CREAM TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2.5; 9.375; 6.25; 1.875 mL/125mL; mL/125mL; mL/125mL; mL/125mL 68828-104_d510046d-f6c1-48d4-9062-23b2a449873b 68828-104 HUMAN OTC DRUG Clear Pore Clarifier Matte Dynamics Salicylic Acid GEL TOPICAL 20120605 OTC MONOGRAPH FINAL part333D Jafra Cosmetics International Inc SALICYLIC ACID 1 g/100mL 68828-105_4f85b3fe-4b3e-4d1c-975d-f62af753a8d0 68828-105 HUMAN OTC DRUG Oil Control testers SPF 15 Octinoxate, Octisalate, Octocrylene LOTION TOPICAL 20120605 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 4.8; 2.4; 1.6 mL/80mL; mL/80mL; mL/80mL 68828-106_b7139484-a367-449d-b3b5-dcc388d497b8 68828-106 HUMAN PRESCRIPTION DRUG Jafra Always Color Stay-on Makeup SPF 10 Titanium Dioxide, Octinoxate LIQUID TOPICAL 20120730 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; TITANIUM DIOXIDE 2; 6.4 mL/80mL; mL/80mL 68828-108_af461be4-a018-43c5-bf94-85d9c6ddd6ed 68828-108 HUMAN OTC DRUG Jafra Always color stay on makeup SPF 10 Titanium Dioxide, Octinoxate LOTION TOPICAL 20120730 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 2; 6.4 mL/80mL; mL/80mL 68828-109_64de502e-7858-4584-b824-0fa6c712ae28 68828-109 HUMAN OTC DRUG Jafra Calming Dynamics Calming Testers KIT 20120630 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc 68828-111_ad22c152-00ea-4fb8-bd10-e749369ed9a5 68828-111 HUMAN OTC DRUG Jafra Pro Avobenzone, Homosalate, Octisalate, Octocrylene KIT TOPICAL 20120730 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc 68828-113_7ba21de0-305e-4aee-b06f-52b6a95d092c 68828-113 HUMAN OTC DRUG Balancing SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20121024 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.5; 7; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL 68828-114_60340c97-f5ac-4c23-92d4-57113cc1ccba 68828-114 HUMAN OTC DRUG Mattifying Broad Spectrum SPF 15 Jafra Avobenzone, Octisalate, Octocrylene,Oxybenzone LOTION TOPICAL 20121025 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.75; 5; 7.5; 2 g/100mL; g/100mL; g/100mL; g/100mL 68828-115_7c1342ad-01eb-40c6-86e6-a6e376c05a6f 68828-115 HUMAN OTC DRUG Gentle Hydrating Day Cream Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.5; 7; 4; 1 g/100mL; g/100mL; g/100mL; g/100mL 68828-116_7e3cb24d-8218-4c71-bf2b-749df422cec4 68828-116 HUMAN OTC DRUG Moisuture Replenishing Broad Spectrum SPf 15 Jafra Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20121114 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.5; 6.5; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL 68828-117_437b1a20-4e79-45cb-822b-791b29ca2707 68828-117 HUMAN OTC DRUG Skin Defense Concealer Broad Spectrum SPF 15 Jafra Cosmetics Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL 68828-118_321522e8-16cc-40dc-acdf-1aecf0adb572 68828-118 HUMAN OTC DRUG Hand Care Day care Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL 68828-119_b3330ad8-065f-4d6c-8bbc-d3485443716a 68828-119 HUMAN OTC DRUG Tea Blend Samples Jafra Avobenzone, Octinoxate, Octisalate KIT 20130118 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL 68828-121_0e3dd6c0-cce8-4391-9fa9-592b15f563bc 68828-121 HUMAN OTC DRUG Control Dynamics kit Jafra Control Dynamics tester KIT 20130122 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc 68828-123_547d6c02-55fa-4d31-a309-d213fcab06d6 68828-123 HUMAN OTC DRUG Tender Moments Baby Sunscreen Broad Spectrum SPF 45 Jafra Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20130213 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 7; 2 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 68828-124_0b39592e-7915-4932-a0f1-b7598e043f8e 68828-124 HUMAN OTC DRUG Hand Complex Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Oxybenzone JELLY TOPICAL 20130213 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 2 g/75mL; g/75mL; g/75mL; g/75mL 68828-125_83df8f52-f366-4cba-9a6d-98bcafea87d7 68828-125 HUMAN OTC DRUG Soft Ivory Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-126_2be4224d-abca-48dc-aa09-5cdd9642245f 68828-126 HUMAN OTC DRUG Soft Beige Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-127_12ce168c-288e-4237-b512-3e10453169cb 68828-127 HUMAN OTC DRUG Toast Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-128_22f886d2-4c43-4fdd-a9cc-45fcbd642d6d 68828-128 HUMAN OTC DRUG Toffee Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-129_5daadac0-815f-4320-befb-d246022433bf 68828-129 HUMAN OTC DRUG Clear Blemish Treatment Jafra Salicylic Acid GEL TOPICAL 20120619 OTC MONOGRAPH FINAL part358H JAFRA COSMETICS INTERNATIONAL SALICYLIC ACID 2 g/151mL 68828-130_09d8409f-3809-4a11-84e0-a0b7fdcb4191 68828-130 HUMAN OTC DRUG True Beige Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-131_a2971002-0c1b-45ed-9606-5c11e1854426 68828-131 HUMAN OTC DRUG Daily Defense SPF 15 Jafra Octinoxate, Zinc Oxide CREAM TOPICAL 20120530 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; ZINC OXIDE 7.5; 3 g/100mL; g/100mL 68828-132_0ec90acf-e136-4d58-bf64-dd6582911753 68828-132 HUMAN OTC DRUG Broad Spectrum SPF 15 Daily Eye Treat Jafra Avobenzone, Homosalate, Octisalate, Octoorylene CREAM TOPICAL 20130408 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 7.5; 5; 1.75 g/100mL; g/100mL; g/100mL; g/100mL 68828-133_d6e1f3aa-ad38-447a-8b5e-0c85b32c23cf 68828-133 HUMAN OTC DRUG Face Lift Broad Spectrum SPF 20 Jafra Pro Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 7 g/100mL; g/100mL; g/100mL; g/100mL 68828-134_fba6fea6-ff9b-4663-8e3e-347857d42d40 68828-134 HUMAN OTC DRUG Pure Porcelain Skin Defense Makeup SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL 68828-135_fba6fea6-ff9b-4663-8e3e-347857d42d40 68828-135 HUMAN OTC DRUG Pure Ivory Skin Defense Makeup SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL 68828-136_fba6fea6-ff9b-4663-8e3e-347857d42d40 68828-136 HUMAN OTC DRUG Pure Champagne Skin Defense Makeup SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL 68828-137_fba6fea6-ff9b-4663-8e3e-347857d42d40 68828-137 HUMAN OTC DRUG Pure Tan Skin Defense Makeup SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL 68828-138_fba6fea6-ff9b-4663-8e3e-347857d42d40 68828-138 HUMAN OTC DRUG Pure Cashmere Skin Defense Makeup SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL 68828-139_e4dc7528-9efe-4164-97bc-4c772a70a9b5 68828-139 HUMAN OTC DRUG Natural Tan Oil Controlling Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LIQUID TOPICAL 20130419 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL 68828-140_e4dc7528-9efe-4164-97bc-4c772a70a9b5 68828-140 HUMAN OTC DRUG Ivory Oil Controlling Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LIQUID TOPICAL 20130419 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL 68828-141_e4dc7528-9efe-4164-97bc-4c772a70a9b5 68828-141 HUMAN OTC DRUG Barely Beige Oil Controlling Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LIQUID TOPICAL 20130419 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL 68828-142_4cc7bf50-a93d-4223-bb0e-8a020930259b 68828-142 HUMAN OTC DRUG Natural Tan Moisturizing Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LIQUID TOPICAL 20130423 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL 68828-143_4cc7bf50-a93d-4223-bb0e-8a020930259b 68828-143 HUMAN OTC DRUG Ivory Moisturizing Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LIQUID TOPICAL 20130423 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL 68828-144_4cc7bf50-a93d-4223-bb0e-8a020930259b 68828-144 HUMAN OTC DRUG Barely Beige Moisturizing Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LIQUID TOPICAL 20130423 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL 68828-145_4cc7bf50-a93d-4223-bb0e-8a020930259b 68828-145 HUMAN OTC DRUG Cashmere Moisturizing Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LIQUID TOPICAL 20130423 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL 68828-146_097724fb-0dc0-4450-bf94-fa7d6ff42f1b 68828-146 HUMAN OTC DRUG Warm Ginger Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-147_9f38acf2-5ebc-4c2a-83b6-2813563edcc3 68828-147 HUMAN OTC DRUG SKIN DEFENSE MAKEUP SPF-15 OCTINOXATE OCTISALATE OXYBENZONE LOTION TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL 68828-148_d87ff653-9abc-45f2-b8b5-61570538ac8e 68828-148 HUMAN OTC DRUG Bisque Always Color Stay-on Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium dioxide LIQUID TOPICAL 20130221 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-149_d48b8744-03bf-42eb-b336-643736e7b85c 68828-149 HUMAN OTC DRUG Hydration Dynamics Kit Jafra Kit KIT 20130125 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL 68828-150_3a483673-b894-4efe-9021-5c10cdd637ee 68828-150 HUMAN OTC DRUG BALANCE DYNAMICS BALANCING SPF 15 OCTISALATE OXYBENZONE OCTINOXATE LOTION TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 7; 4; 2 g/100mL; g/100mL; g/100mL 68828-152_61349046-fe58-4069-b4ab-67fab71de0af 68828-152 HUMAN OTC DRUG Calming Dynamics Kit Jafra Calming Testers KIT 20121114 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc 68828-154_9d5b3184-9594-40ad-88f8-39a377f6e336 68828-154 HUMAN OTC DRUG Balancing Dynamics Kit Jafra Balancing Dynamics KIT 20121116 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL 68828-155_33f8450a-f387-401c-8ed6-cb98a87793cf 68828-155 HUMAN OTC DRUG CALM DYNAMICS GENTLE HYDRATING DAY SPF 15 OCTINOXATE OCTISALATE OXYBENZONE CREAM TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 7; 4; 2 g/100mL; g/100mL; g/100mL 68828-156_b3ef9b24-e8b0-4787-a9a4-21aee5a47a48 68828-156 HUMAN OTC DRUG HYDRATION DYNAMICS MOISTURE REPLENISHMENT SPF 15 OCTINOXATE OCTISALATE OXYBENZONE CREAM TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 6.5; 4; 2 g/100mL; g/100mL; g/100mL 68828-158_4913fc30-23a1-463b-9d86-16c39762d979 68828-158 HUMAN OTC DRUG CONTROL DYNAMICS MATTIFYING SPF 15 OCTINOXATE OCTISALATE OXYBENZONE LOTION TOPICAL 20120514 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 7; 4; 2 g/100mL; g/100mL; g/100mL 68828-159_dc716edf-ed5d-4977-bcfd-7f273021c969 68828-159 HUMAN OTC DRUG Facial Boosting Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 25; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL 68828-160_a8a781de-d2c9-4a3f-99ec-6f1053197410 68828-160 HUMAN OTC DRUG Tea Blend Daily Moisturizer SPF 15 Jafra Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20120312 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; OCTINOXATE; OCTISALATE 2.5; 7.5; 5 g/100mL; g/100mL; g/100mL 68828-161_a06fb75e-f5c0-4823-ae22-598895b4dbb4 68828-161 HUMAN OTC DRUG Double Duty Face Protector SPF 15 Jafra Octinoxate, Octisalate, Zinc Oxide LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 2.9 g/100mL; g/100mL; g/100mL 68828-162_3c87fec9-444d-4427-a2c8-28fd80bc1540 68828-162 HUMAN OTC DRUG Sunscreen SPF 30 Jafra Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.79; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 68828-163_471ec4a3-3e85-4fce-be2d-b2dbdadd35d7 68828-163 HUMAN OTC DRUG HARMONY DYNAMICS FACIAL BOOSTING SPF 15 OCTINOXATE OCTISALATE OXYBENZONE CREAM TOPICAL 20120419 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 7; 4; 2 g/100mL; g/100mL; g/100mL 68828-164_45815c73-2e38-4d98-9087-da2d1ffb4215 68828-164 HUMAN OTC DRUG Always Color Stay on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide CREAM TOPICAL 20121126 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 7.3 g/100mL; g/100mL; g/100mL 68828-165_970edce0-ce69-4992-a3e1-72cf8e764831 68828-165 HUMAN OTC DRUG Sunscreen Broad Spectrum SPF 50 Jafra Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20130219 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 10; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 68828-166_1e447ef1-a385-4cb7-8907-b8e3d491b4fd 68828-166 HUMAN OTC DRUG Face and Body Sunscreen SPF 35 Jafra Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.79; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 68828-167_00a13542-f01a-42a6-9ab3-f790e11e07f3 68828-167 HUMAN OTC DRUG Face Protector Broad Spectrum SPF 40 Jafra Octinoxate, Octisalate, Octocrylene, Oxybenzone, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 1.5; 2; 4.25; 2.9 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 68828-168_46d49ac8-2bc8-4402-81ae-542c481727fe 68828-168 HUMAN OTC DRUG Cafe au lait Always Stay-on Makeup Broad Spectrum SPF 15 Jafra octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130222 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-169_02e486a3-ba31-4e14-8eab-16f2622c4e31 68828-169 HUMAN OTC DRUG SImply Beige Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-170_ffca8a22-795a-41ea-b917-35c7897b17ca 68828-170 HUMAN OTC DRUG Light Skin Defense Concealer Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL 68828-171_ffca8a22-795a-41ea-b917-35c7897b17ca 68828-171 HUMAN OTC DRUG Medium Skin Defense Concealer Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL 68828-172_ffca8a22-795a-41ea-b917-35c7897b17ca 68828-172 HUMAN OTC DRUG Dark Skin Defense Concealer Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL 68828-173_2cffc2ae-a29e-4c51-921a-924469c5f053 68828-173 HUMAN OTC DRUG Desert Beige Always Stay-on Makeup SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130227 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL 68828-174_12b10ce1-0d84-41b2-b4f6-7d154bf14708 68828-174 HUMAN OTC DRUG BeCause Antibacterial Hand Jafra Ethyl Alcohol GEL TOPICAL 20130730 OTC MONOGRAPH NOT FINAL part333E Jafra Cosmetics International Inc ALCOHOL 62 g/100mL 68828-175_a51d62e3-72a6-4b77-95f6-04597ca9597e 68828-175 HUMAN OTC DRUG BeCause Antibacterial Hand Jafra Triclosan CREAM TOPICAL 20130731 OTC MONOGRAPH NOT FINAL part333A Jafra Cosmetics International Inc TRICLOSAN .3 g/100mL 68828-177_82304d10-ab20-41ce-91c5-9f412d777084 68828-177 HUMAN OTC DRUG Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Jafra Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LIQUID TOPICAL 20130930 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 7; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 68828-178_3c7865ef-2d2d-4a32-a7f7-739f170f204c 68828-178 HUMAN OTC DRUG Balancing Day Moisture Broad Spectrum SPF 15 Jafra Avobenzone,Octinoxate, Octisalate, Octisalate, Oxybenzone CREAM TOPICAL 20131028 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.75; 7.5; 5; 2 g/100mL; g/100mL; g/100mL; g/100mL 68828-179_fc4a5bf0-8e8b-45d8-b6f8-4a2c6b6f50b7 68828-179 HUMAN OTC DRUG Hydrating day moisture broad spectrum SPF15 Jafra Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20131125 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.5; 6.5; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL 68828-180_41f21db1-3d44-47d6-a308-b74258017f35 68828-180 HUMAN OTC DRUG Mattifying Day Moisture Broad Spectrum SPF 15 Jafra Avobenzone, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20131126 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.75; 5; 7.5; 2 g/100mL; g/100mL; g/100mL; g/100mL 68828-181_9f2b18c2-f0b9-45f5-ac7d-ed0073e80215 68828-181 HUMAN OTC DRUG Advanced Dynamics Soothing day Moisture Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Octocrylene, oxybenzone CREAM TOPICAL 20131126 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.5; 6.5; 4; 2.75; 2 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 68828-182_8e2b8f94-bea8-4f14-a7fb-1a4d322ba397 68828-182 HUMAN OTC DRUG Balancing Day Moisture Broad Spectrum SPF 15 Jafra Avobenzone,Octinoxate, Octisalate, Octisalate, Oxybenzone CREAM TOPICAL 20131028 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.75; 7.5; 5; 2 g/100mL; g/100mL; g/100mL; g/100mL 68828-183_6ca921a3-a09e-49c3-9d7a-08f4dc5a0992 68828-183 HUMAN OTC DRUG Tawny Beige Always Color Stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide CREAM TOPICAL 20131212 OTC MONOGRAPH FINAL part352 Jafra Cosmetics international OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.29 g/100mL; g/100mL; g/100mL 68828-184_16316d05-823f-42d1-8516-a1529a9f2107 68828-184 HUMAN OTC DRUG Sienna Always Color Stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide CREAM TOPICAL 20131212 OTC MONOGRAPH FINAL part352 Jafra Cosmetics international OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.29 g/100mL; g/100mL; g/100mL 68828-185_3653cf60-d5c1-41a0-ab3e-53956e8f7344 68828-185 HUMAN OTC DRUG Warm Honey Always Color Stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide CREAM TOPICAL 20131212 OTC MONOGRAPH FINAL part352 Jafra Cosmetics international OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.29 g/100mL; g/100mL; g/100mL 68828-186_0542540e-ba6b-4a58-9bee-cb9b9c654d75 68828-186 HUMAN OTC DRUG Ships Ahoy Seashore Sunscreen Broad Spectrum SPF 30 Jafra Avobenzone, Homosalate,Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20140224 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.79; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 68828-187_a0c694ec-7006-42e1-a77c-35eaa4a0fe97 68828-187 HUMAN OTC DRUG Sun Broad Spectrum SPF 30 Jafra Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20140226 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.79; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 68828-188_349b60f8-8518-46a6-9dce-e8ae90c69d91 68828-188 HUMAN OTC DRUG Sun Face Protector Sunscreen Broad Spectrum SPF 50 Jafra Avobenzone, Homosalate, Octisalate,Octocrylene, Oxybenzone LOTION TOPICAL 20140227 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 10; 10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 68828-190_720cb22b-5b7c-49df-a8ae-f4bdfcf4bebc 68828-190 HUMAN OTC DRUG CC Cream Complexion Corrector Light Medium Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20140303 OTC MONOGRAPH FINAL part352 Jafra cosmetics International AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 5; 4; 1.8 g/100mL; g/100mL; g/100mL; g/100mL 68828-191_b74fd82f-a434-402f-96e8-21457c43d3f8 68828-191 HUMAN OTC DRUG CC Cream Complexion Corrector Medium Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20140303 OTC MONOGRAPH FINAL part352 Jafra cosmetics International AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 5; 4; 1.8 g/100mL; g/100mL; g/100mL; g/100mL 68828-192_76b8b357-aeea-4252-b63b-625f03ee5b5c 68828-192 HUMAN OTC DRUG CC Cream Complexion Corrector Medium Dark Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20140303 OTC MONOGRAPH FINAL part352 Jafra cosmetics International AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 5; 4; 1.8 g/100mL; g/100mL; g/100mL; g/100mL 68828-193_69747210-d7ce-41bf-ab33-8bb7d96172ac 68828-193 HUMAN OTC DRUG CC Cream Complexion Corrector Dark Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20140303 OTC MONOGRAPH FINAL part352 Jafra cosmetics International AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 5; 4; 1.8 g/100mL; g/100mL; g/100mL; g/100mL 68828-194_5004376e-cc15-4ce1-880e-41019a7ad329 68828-194 HUMAN OTC DRUG Skin Balancing Makeup Broad Spectrum SPF 20 Jafra Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part352 Jafra Cosmetics AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 6; 4; 2.7 g/100mL; g/100mL; g/100mL; g/100mL 68828-197_fee5bf5c-bb6d-4d47-a155-eab47470a7eb 68828-197 HUMAN OTC DRUG Sensitive Skin antiperspirant deodorant roll-on Jafra Daily Aluminum Chlorohydrate LIQUID TOPICAL 20140902 OTC MONOGRAPH FINAL part350 Jafra cosmetics International ALUMINUM CHLOROHYDRATE 12.3 g/100mL 68828-198_a220fce8-5d5e-407b-937e-108253d71303 68828-198 HUMAN OTC DRUG Antiperspirant Deodorant Roll-on Jafra Daily Aluminum Chlorohydrate LIQUID TOPICAL 20140814 OTC MONOGRAPH FINAL part350 Jafra cosmetics International ALUMINUM CHLOROHYDRATE 12.3 g/100mL 68828-199_f2fc3dbb-1ed9-4eec-940e-ef009f6f31f3 68828-199 HUMAN OTC DRUG Skin brightening antiperspirant deodorant roll-on Jafra Daily Aluminum Chlorohydrate LIQUID TOPICAL 20140903 OTC MONOGRAPH FINAL part350 Jafra cosmetics International ALUMINUM CHLOROHYDRATE 12.3 g/100mL 68828-200_d7f34951-c81a-42ed-b1c7-04830fd637ea 68828-200 HUMAN OTC DRUG hair minimizing antiperspirant deodorant roll-on Jafra Daily Aluminum Chlorohydrate LIQUID TOPICAL 20140904 OTC MONOGRAPH FINAL part350 Jafra cosmetics International ALUMINUM CHLOROHYDRATE 100 g/100mL 68828-201_b823ff10-571b-40ac-bb79-470b7256f971 68828-201 HUMAN OTC DRUG defy time protector moisturizer broad spectrum SPF 15 Jafra time dynamics Octinoxate, Zinc Oxide CREAM TOPICAL 20141125 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International OCTINOXATE; ZINC OXIDE 7.5; 3 g/100mL; g/100mL 68828-202_779eb2d2-a312-4349-baf0-01e762cc8e6b 68828-202 HUMAN OTC DRUG recover skin boosting moisturizer broad spectrum SPF 15 Jafra gold dynamics Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.5; 7.5; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL 68850-001_e5d67a25-6e03-40ee-8290-5f41583e51b1 68850-001 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone ELIXIR ORAL 19760921 ANDA ANDA084754 STI Pharma LLC DEXAMETHASONE .5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 68850-004_f8939d3c-f0f7-4fb3-baf6-6b150c426f50 68850-004 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET, FILM COATED ORAL 20061215 NDA AUTHORIZED GENERIC NDA016320 STI Pharma ETHAMBUTOL HYDROCHLORIDE 100 mg/1 Antimycobacterial [EPC] 68850-005_f8939d3c-f0f7-4fb3-baf6-6b150c426f50 68850-005 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET, FILM COATED ORAL 20061215 NDA AUTHORIZED GENERIC NDA016320 STI Pharma ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] 68850-010_b0eebb21-6f21-4399-a9f4-36a821380584 68850-010 HUMAN PRESCRIPTION DRUG Myambutol Ethambutol hydrochloride TABLET, FILM COATED ORAL 20070810 NDA NDA016320 STI Pharma, LLC ETHAMBUTOL HYDROCHLORIDE 100 mg/1 Antimycobacterial [EPC] 68850-012_b0eebb21-6f21-4399-a9f4-36a821380584 68850-012 HUMAN PRESCRIPTION DRUG Myambutol Ethambutol hydrochloride TABLET, FILM COATED ORAL 20070810 NDA NDA016320 STI Pharma, LLC ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] 68852-7777_7003bd4f-4d67-4de9-b18e-a0946ebe0844 68852-7777 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN COMPRESSED GAS RESPIRATORY (INHALATION) 20041010 UNAPPROVED MEDICAL GAS Wolf Industries dba Grace Healthcare, Inc OXYGEN 99 L/100L 68852-7778_7003bd4f-4d67-4de9-b18e-a0946ebe0844 68852-7778 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20040801 UNAPPROVED MEDICAL GAS Wolf Industries dba Grace Healthcare, Inc OXYGEN 99 L/100L 68858-100_d41de66f-5264-40f0-80e1-753964e9a67b 68858-100 HUMAN OTC DRUG MAZON MEDICATED PSORIASIS COAL TAR CREAM TOPICAL 20101101 OTC MONOGRAPH FINAL part358H Advantage Sales and Marketing COAL TAR .55 g/100g 68875-0101_6852733b-dd5d-4232-a3c1-123c49eaa61b 68875-0101 HUMAN PRESCRIPTION DRUG Gattex teduglutide INJECTION, POWDER, FOR SOLUTION SUBCUTANEOUS 20121221 NDA NDA203441 NPS Pharmaceuticals TEDUGLUTIDE 5 mg/1 68875-0102_6852733b-dd5d-4232-a3c1-123c49eaa61b 68875-0102 HUMAN PRESCRIPTION DRUG Gattex teduglutide KIT 20121221 NDA NDA203441 NPS Pharmaceuticals 68875-0103_6852733b-dd5d-4232-a3c1-123c49eaa61b 68875-0103 HUMAN PRESCRIPTION DRUG Gattex teduglutide KIT 20121221 NDA NDA203441 NPS Pharmaceuticals 68877-001_132f0046-9189-400f-b0ab-f084d7c1470a 68877-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040525 UNAPPROVED MEDICAL GAS United States Cylinder Gas Corporation OXYGEN 990 mL/L 68877-002_4913eea7-4558-463d-a1fc-f096fdf655d3 68877-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20101010 UNAPPROVED MEDICAL GAS United States Cylinder Gas Corporation NITROGEN 900 mL/L 68878-115_9944bf93-ebbc-4589-97da-4b87cf781c06 68878-115 HUMAN OTC DRUG ANTIBACTERIAL AMBER FLORAL Antibacterial Amber Floral Hand Soap LIQUID TOPICAL 20040506 OTC MONOGRAPH NOT FINAL part333A Theochem Laboratories Inc TRICLOSAN 2 g/L 68878-118_4c10210c-8cff-4931-a507-bb01e8d5003e 68878-118 HUMAN OTC DRUG Theochem Foaming Hand Sanitizer FOAMING HAND SANTIZER LIQUID TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part333E Theochem Laboratories Inc BENZALKONIUM CHLORIDE .1 mg/mL 68878-119_518ac54d-fdd1-4eda-ab42-8818bb33d176 68878-119 HUMAN OTC DRUG Foaming Hand Sanitizer Foaming Hand Sanitizer LIQUID TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part333A Theochem Laboratories Inc BENZALKONIUM CHLORIDE .1 mg/mL 68878-120_c9a39a32-00de-42f0-ba65-c1ee1ce214ca 68878-120 HUMAN OTC DRUG Theochem Tea Tree Hand and Body Wash Tea Tree Hand and Body Wash SOAP TOPICAL 20040916 OTC MONOGRAPH NOT FINAL part333A Theochem Laboratories TRICLOSAN 2 g/L 68878-130_6a1a4089-eb4e-4e37-a968-e99e5eaacd01 68878-130 HUMAN OTC DRUG Theochem White Tea Hand and Body Wash White Tea Hand and Body Wash SOAP TOPICAL 20080110 OTC MONOGRAPH NOT FINAL part333A Theochem Laboratories Inc TRICLOSAN 2 g/L 68878-131_8cab5a87-2828-409b-8884-2638198e7758 68878-131 HUMAN OTC DRUG White Tea Antibacterial White Tea Antibacterial SOAP TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part333A Theochem Laboratories, Inc TRICLOSAN .002 g/mL 68878-140_32a6f64d-784d-49d0-a5bd-37a5dc5f2420 68878-140 HUMAN OTC DRUG Theochem Tea Tree Hand and Body Wash Tea Tree Hand and Body Wash SOAP TOPICAL 20080923 OTC MONOGRAPH NOT FINAL part333A Theochem Laboratories Inc TRICLOSAN .002 g/mL 6889-0312_63411e08-6c53-49c2-8671-03930db33868 6889-0312 HUMAN OTC DRUG Beautipharm All Day Moisturizing Balm SPF 10 Sunscreen CREAM TOPICAL 20140630 OTC MONOGRAPH FINAL part352 Linde Eckstein GmbH + Co. KG OCTINOXATE; OCTOCRYLENE 2; 2 g/50mL; g/50mL 6889-0315_e760d894-9834-4c04-b910-a73f52b57f6f 6889-0315 HUMAN OTC DRUG Beautipharm Body Moisturizer SPF 10 Sunscreen CREAM TOPICAL 20140630 OTC MONOGRAPH FINAL part352 Linde Eckstein GmbH + Co. KG OCTINOXATE; OCTOCRYLENE 10; 10 g/250mL; g/250mL 6889-0319_d7f6b0c2-e85c-4587-8b4a-ba79d6c6ad4d 6889-0319 HUMAN OTC DRUG Beautipharm Eye Care Balm SPF 10 Sunscreen CREAM TOPICAL 20140630 OTC MONOGRAPH FINAL part352 Linde Eckstein GmbH + Co. KG OCTINOXATE; OCTOCRYLENE 1.33; 1.33 g/30mL; g/30mL 68899-0001_c7af6197-fded-4de9-aa64-7535d3dda2db 68899-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040424 UNAPPROVED MEDICAL GAS Western Reserve Home Medical Eq. OXYGEN 99 L/100L 68915-256_16b04391-8d87-4796-9323-a0a960eb592a 68915-256 HUMAN OTC DRUG AVVA vaginal Benzalkonium Chloride DOUCHE VAGINAL 20110520 OTC MONOGRAPH NOT FINAL part333A Eastern Century Pharmaceuticals BENZALKONIUM CHLORIDE .1 mL/100mL 68915-280_5e976930-5765-48e6-a8c5-92a18e931e7b 68915-280 HUMAN OTC DRUG Guardian Vaginal Benzalkonium Chloride DOUCHE VAGINAL 20110523 OTC MONOGRAPH NOT FINAL part333A Eastern Century Pharmaceuticals BENZALKONIUM CHLORIDE 1 mg/mL 68927-0819_5948e403-a8b9-450c-8890-74af7639bf08 68927-0819 HUMAN OTC DRUG Visco-Gel Medicated Round Callus Removers SALICYLIC ACID DISC TOPICAL 20130601 OTC MONOGRAPH FINAL part358F PEDIFIX, INC. SALICYLIC ACID 17.67 mg/1 68927-3063_9b4e4d4d-7c10-4431-86b3-77e7b9497c41 68927-3063 HUMAN OTC DRUG Pedi-Quick OneStep Corn Removers SALICYLIC ACID STRIP TOPICAL 20130601 OTC MONOGRAPH FINAL part358F PEDIFIX, INC. SALICYLIC ACID 4.42 mg/1 68927-3490_603e1c40-92b9-4508-99f0-46c7167fab41 68927-3490 HUMAN OTC DRUG ClotrimazOil Antifungal CLOTRIMAZOLE SOLUTION TOPICAL 20130619 OTC MONOGRAPH FINAL part333C Pedifix, Inc. CLOTRIMAZOLE 10 mg/mL 68927-3491_c61c85e2-e0b8-47e1-b02e-31a00d11138f 68927-3491 HUMAN OTC DRUG Clotrimazole Clotrimazole LIQUID TOPICAL 20140505 OTC MONOGRAPH FINAL part333C Pedifix CLOTRIMAZOLE 10 mg/mL 68927-3492_526db92b-9af6-4bf0-884c-c997b438f22d 68927-3492 HUMAN OTC DRUG FungaZoil Advanced Clotrimazole 1% LIQUID TOPICAL 20140615 OTC MONOGRAPH FINAL part333C Pedifix CLOTRIMAZOLE 10 mg/mL 68957-1092_1b254e29-5a44-4363-a5d6-b1b55c38377c 68957-1092 HUMAN OTC DRUG Hand Sanitizer ALCOHOL GEL TOPICAL 20101004 OTC MONOGRAPH NOT FINAL part333E Suite K Value Added Services LLC ALCOHOL 60 mL/100mL 68968-0514_83198ef0-11c4-11e4-9191-0800200c9a66 68968-0514 HUMAN PRESCRIPTION DRUG CombiPatch (estradiol/norethindrone acetate transdermal system) estradiol/norethindrone acetate transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 19980807 NDA NDA020870 Noven Therapeutics, LLC ESTRADIOL; NORETHINDRONE ACETATE .05; .14 mg/d; mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 68968-0525_83198ef0-11c4-11e4-9191-0800200c9a66 68968-0525 HUMAN PRESCRIPTION DRUG CombiPatch (estradiol/norethindrone acetate transdermal system) estradiol/norethindrone acetate transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 19980807 NDA NDA020870 Noven Therapeutics, LLC ESTRADIOL; NORETHINDRONE ACETATE .05; .25 mg/d; mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 68968-2010_58000094-10f3-11e4-9191-0800200c9a66 68968-2010 HUMAN PRESCRIPTION DRUG PEXEVA paroxetine mesylate TABLET, FILM COATED ORAL 20030703 NDA NDA021299 NOVEN THERAPEUTICS, LLC PAROXETINE MESYLATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68968-2020_58000094-10f3-11e4-9191-0800200c9a66 68968-2020 HUMAN PRESCRIPTION DRUG PEXEVA paroxetine mesylate TABLET, FILM COATED ORAL 20030703 NDA NDA021299 NOVEN THERAPEUTICS, LLC PAROXETINE MESYLATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68968-2030_58000094-10f3-11e4-9191-0800200c9a66 68968-2030 HUMAN PRESCRIPTION DRUG PEXEVA paroxetine mesylate TABLET, FILM COATED ORAL 20030703 NDA NDA021299 NOVEN THERAPEUTICS, LLC PAROXETINE MESYLATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68968-2040_58000094-10f3-11e4-9191-0800200c9a66 68968-2040 HUMAN PRESCRIPTION DRUG PEXEVA paroxetine mesylate TABLET, FILM COATED ORAL 20030703 NDA NDA021299 NOVEN THERAPEUTICS, LLC PAROXETINE MESYLATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68968-3125_6c1c7387-6c54-42f3-82b3-5be32070a14a 68968-3125 HUMAN PRESCRIPTION DRUG STAVZOR valproic acid CAPSULE, DELAYED RELEASE ORAL 20080801 20150228 NDA NDA022152 Noven Therapeutics, LLC VALPROIC ACID 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68968-3250_6c1c7387-6c54-42f3-82b3-5be32070a14a 68968-3250 HUMAN PRESCRIPTION DRUG STAVZOR valproic acid CAPSULE, DELAYED RELEASE ORAL 20080801 20150228 NDA NDA022152 Noven Therapeutics, LLC VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68968-3500_6c1c7387-6c54-42f3-82b3-5be32070a14a 68968-3500 HUMAN PRESCRIPTION DRUG STAVZOR valproic acid CAPSULE, DELAYED RELEASE ORAL 20080801 20150228 NDA NDA022152 Noven Therapeutics, LLC VALPROIC ACID 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 68968-4492_6e8385da-1715-486c-abf2-fa8e33350368 68968-4492 HUMAN PRESCRIPTION DRUG LITHOBID lithium carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19790427 NDA NDA018027 NOVEN THERAPEUTICS, LLC LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] 68968-5552_367271f1-642e-11e3-949a-0800200c9a66 68968-5552 HUMAN PRESCRIPTION DRUG Daytrana methylphenidate PATCH TRANSDERMAL 20060406 NDA NDA021514 Noven Therapeutics, LLC METHYLPHENIDATE 10 mg/9h Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68968-5553_367271f1-642e-11e3-949a-0800200c9a66 68968-5553 HUMAN PRESCRIPTION DRUG Daytrana methylphenidate PATCH TRANSDERMAL 20060406 NDA NDA021514 Noven Therapeutics, LLC METHYLPHENIDATE 15 mg/9h Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68968-5554_367271f1-642e-11e3-949a-0800200c9a66 68968-5554 HUMAN PRESCRIPTION DRUG Daytrana methylphenidate PATCH TRANSDERMAL 20060406 NDA NDA021514 Noven Therapeutics, LLC METHYLPHENIDATE 20 mg/9h Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68968-5555_367271f1-642e-11e3-949a-0800200c9a66 68968-5555 HUMAN PRESCRIPTION DRUG Daytrana methylphenidate PATCH TRANSDERMAL 20060406 NDA NDA021514 Noven Therapeutics, LLC METHYLPHENIDATE 30 mg/9h Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 68968-6610_98db0f80-459e-11e4-916c-0800200c9a66 68968-6610 HUMAN PRESCRIPTION DRUG Minivelle estradiol FILM, EXTENDED RELEASE TRANSDERMAL 20121220 NDA NDA203752 Noven Therapeutics, LLC ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 68968-6625_98db0f80-459e-11e4-916c-0800200c9a66 68968-6625 HUMAN PRESCRIPTION DRUG Minivelle estradiol FILM, EXTENDED RELEASE TRANSDERMAL 20121220 NDA NDA203752 Noven Therapeutics, LLC ESTRADIOL .025 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 68968-6637_98db0f80-459e-11e4-916c-0800200c9a66 68968-6637 HUMAN PRESCRIPTION DRUG Minivelle estradiol FILM, EXTENDED RELEASE TRANSDERMAL 20121220 NDA NDA203752 Noven Therapeutics, LLC ESTRADIOL .0375 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 68968-6650_98db0f80-459e-11e4-916c-0800200c9a66 68968-6650 HUMAN PRESCRIPTION DRUG Minivelle estradiol FILM, EXTENDED RELEASE TRANSDERMAL 20121220 NDA NDA203752 Noven Therapeutics, LLC ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 68968-6675_98db0f80-459e-11e4-916c-0800200c9a66 68968-6675 HUMAN PRESCRIPTION DRUG Minivelle estradiol FILM, EXTENDED RELEASE TRANSDERMAL 20121220 NDA NDA203752 Noven Therapeutics, LLC ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] 68968-9075_1125def0-7aa3-11e4-82f8-0800200c9a66 68968-9075 HUMAN PRESCRIPTION DRUG BRISDELLE paroxetine CAPSULE ORAL 20130628 NDA NDA204516 Noven Therapeutics, LLC PAROXETINE MESYLATE 7.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 68971-001_72184c71-b543-4075-8c74-07303e2d79b0 68971-001 HUMAN OTC DRUG X-PEL Anti-Lice Apis Mellifica, Carbolicum Acidum, Ledum Palustre SHAMPOO TOPICAL 20140415 UNAPPROVED HOMEOPATHIC Briangeli Beauty Enterprises APIS MELLIFERA; LEDUM PALUSTRE TWIG; PHENOL 15; 15; 15 [hp_X]/170g; [hp_X]/170g; [hp_X]/170g 68971-002_f4883afe-8ee1-4bad-a973-60392b36d51b 68971-002 HUMAN OTC DRUG X-PEL PURE Anti-Lice Apis Mellifica, Carbolicum Acidum, Ledum Palustre SHAMPOO TOPICAL 20140415 UNAPPROVED HOMEOPATHIC Briangelis Beauty Entps Corp APIS MELLIFERA; LEDUM PALUSTRE TWIG; PHENOL 15; 15; 15 [hp_X]/170g; [hp_X]/170g; [hp_X]/170g 68973-001_f18f14a5-84ba-47a4-bc6c-23f5c232a8c5 68973-001 HUMAN OTC DRUG Bon Balm Penetrating Pain Relief Menthol Methyl Salicylate OIL TOPICAL 20140515 OTC MONOGRAPH NOT FINAL part348 PMC TRADE, EXPORT AND IMPORT CAMPHOR (SYNTHETIC); MENTHOL 6; 1.25 g/100mL; g/100mL 68973-002_b7c1dcd4-75d3-44c2-8344-ca5e0ddabddc 68973-002 HUMAN OTC DRUG Renuee dimethicone CREAM TOPICAL 20140715 OTC MONOGRAPH FINAL part347 PMC TRADE, EXPORT AND IMPORT DIMETHICONE 2 g/100g 68982-850_85bd450d-78a0-495d-be01-00194a92dcbe 68982-850 PLASMA DERIVATIVE Octagam Immune Globulin (Human) Immune Globulin SOLUTION INTRAVENOUS 20040521 BLA BLA125062 Octapharma USA Inc HUMAN IMMUNOGLOBULIN G 100 mg/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 68983-001_d70f5474-0ac6-4267-8d98-430cf956a75b 68983-001 HUMAN OTC DRUG Pac-Dent Top Gel Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Pac-Dent International, Inc. BENZOCAINE 200 mg/g 68983-002_8d727668-4d6f-4231-ba4c-6eea6f64b3b7 68983-002 HUMAN OTC DRUG Pac-Dent Top Gel Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Pac-Dent International, Inc. BENZOCAINE 200 mg/g 68983-003_37c27613-db0b-48ac-942f-e689b5ddfb13 68983-003 HUMAN OTC DRUG Pac-Dent Top Gel Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Pac-Dent International, Inc. BENZOCAINE 200 mg/g 68983-004_b1d92ffc-79ba-4bbb-a294-8fbcf595faf9 68983-004 HUMAN OTC DRUG Pac-Dent Top Gel Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Pac-Dent International, Inc. BENZOCAINE 200 mg/g 68983-005_268d2f91-0e5a-4004-bc98-b417116a5b92 68983-005 HUMAN OTC DRUG Pac-Dent Top Gel Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Pac-Dent International, Inc. BENZOCAINE 200 mg/g 68984-001_9455ae0a-ddd9-4f21-ba3e-f1543cf719c3 68984-001 HUMAN OTC DRUG Vagical CALENDULA OFFICINALIS FLOWERING TOP INSERT VAGINAL 20140529 UNAPPROVED HOMEOPATHIC Farmina sp. z o.o. CALENDULA OFFICINALIS FLOWERING TOP 150 mg/1 68987-001_90970167-adbb-478d-9e47-7b9118ce8c39 68987-001 HUMAN OTC DRUG PureLife Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 PureLife Dental BENZOCAINE 200 mg/g 68987-002_49956e63-dea3-412f-a27e-629f39f28d18 68987-002 HUMAN OTC DRUG PureLife Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 PureLife Dental BENZOCAINE 200 mg/g 68987-003_4038d5fd-6c8b-4f1e-ab52-6f376cef7035 68987-003 HUMAN OTC DRUG PureLife Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 PureLife Dental BENZOCAINE 200 mg/g 68987-004_8a9080de-328f-4f07-8409-0fb7d2319cc1 68987-004 HUMAN OTC DRUG PureLife Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 PureLife Dental BENZOCAINE 200 mg/g 68987-005_181bc740-2575-473f-b12c-f5658e27bc7c 68987-005 HUMAN OTC DRUG PureLife Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 PureLife Dental BENZOCAINE 200 mg/g 68987-006_5eb24723-28f3-447c-abf3-a64408b75b54 68987-006 HUMAN OTC DRUG PureLife Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 PureLife Dental BENZOCAINE 200 mg/g 68987-007_28e840b1-d8d7-4c2a-90a9-b6cb3e1dcab7 68987-007 HUMAN OTC DRUG PureLife Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 PureLife Dental BENZOCAINE 200 mg/g 68987-008_b05c1381-97a7-4a5d-a14e-9c32da1f52ce 68987-008 HUMAN OTC DRUG PureLife Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 PureLife Dental BENZOCAINE 200 mg/g 68987-010_d03fc029-b547-461d-954e-733bdcc53cc8 68987-010 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride GEL DENTAL 20121218 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 5.6 g/454g 68987-011_f1501f81-0646-4134-b864-4df92b016827 68987-011 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride GEL DENTAL 20121218 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 5.6 g/454g 68987-012_5409e6f0-70c0-4f94-a24e-82e9ad1c52a5 68987-012 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride GEL DENTAL 20121218 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 5.6 g/454g 68987-013_cd3394d1-b5ab-425f-95b2-c75acc7fa7cf 68987-013 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride GEL DENTAL 20121218 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 5.6 g/454g 68987-014_35f6a08f-bcb4-4862-a28d-ccfe8a297d5d 68987-014 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride GEL DENTAL 20121218 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 5.6 g/454g 68987-020_4691f44e-1199-4335-aeeb-295eb8afc6bd 68987-020 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130327 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 1.5375 g/125g 68987-021_5198f457-335d-4559-9bad-366c3c2923f5 68987-021 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130327 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 1.5375 g/125g 68987-022_156d6f85-3151-4728-a8a7-85ead3da6f1f 68987-022 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130327 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 1.5375 g/125g 68987-023_d249cff8-92ec-440c-89cb-9b61e0adca0c 68987-023 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130327 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 1.5375 g/125g 68987-024_db76ff96-2fda-4424-b937-90bbb738b5e0 68987-024 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130327 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 1.5375 g/125g 68988-010_ff0a4d93-9b22-4912-9cee-14bf4939d7c5 68988-010 HUMAN OTC DRUG PLAGENTRA MOTHERS BELLY Dimethicone LOTION TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. DIMETHICONE 3 mg/150mL 68988-020_d5ec9155-07c0-4923-b00b-31891275f103 68988-020 HUMAN OTC DRUG PLAGENTRA MOTHERS BELLY Glycerin CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. GLYCERIN 24 g/120g 68988-030_24737d57-e310-465f-ba48-784ee6082cbd 68988-030 HUMAN OTC DRUG PLAGENTRA MOTHERS BELLY Allantoin OIL TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. ALLANTOIN .75 mg/150mL 68988-040_fc769023-e438-4ac4-95e0-119339d9da25 68988-040 HUMAN OTC DRUG PLAGENTRA INTENSIVE CARE Dimethicone CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. DIMETHICONE 2 g/100g 68988-050_103494f4-734e-4bf4-b958-17632f70339d 68988-050 HUMAN OTC DRUG PLAGENTRA INTENSIVE CARE Dimethicone LOTION TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. DIMETHICONE 3 mg/150mL 68988-060_a501ba90-bab6-41ad-87db-9e1156474990 68988-060 HUMAN OTC DRUG PLAGENTRA BABY Dimethicone CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. DIMETHICONE 1 g/100g 68988-070_fb018c88-d502-4095-a538-f8084fd67123 68988-070 HUMAN OTC DRUG PLAGENTRA BABY Glycerin LOTION TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. GLYCERIN 20 mg/100mL 68988-080_103fde0f-196c-4c2a-8295-db3384bb9a12 68988-080 HUMAN OTC DRUG PLAGENTRA BABY BUBBLE WASH Allantoin AEROSOL, FOAM TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. ALLANTOIN 1.25 mg/250mL 68988-090_79cb3c5f-6d46-4843-8780-51252a079b90 68988-090 HUMAN OTC DRUG PLAGENTRA BABY SUNCITY OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 C.A Pharm Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 4.5; 3; 1.8 g/60g; g/60g; g/60g 68988-100_92ee52fc-7fbe-4d53-91aa-1f346f2fdaea 68988-100 HUMAN OTC DRUG PLAGENTRA BABY SOOTHING RELIEF Dimethicone CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. DIMETHICONE 1.6 g/80g 68988-110_1c5a2989-d244-4468-b01b-3ac337d33ee0 68988-110 HUMAN OTC DRUG PLAGENTRA SOOTHING REVOLUTION BB Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 C.A Pharm Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.25; 2.77; .35 g/30g; g/30g; g/30g 68988-120_f15581ea-514d-44c8-af6d-0472d5d4bf0c 68988-120 HUMAN OTC DRUG PLAGENTRA SOOTHING REVOLUTION SUNCITY OCTINOXATE, OCTISALATE CREAM TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 C.A Pharm Co., Ltd. OCTINOXATE; OCTISALATE 2.25; 2.25 g/45g; g/45g 68989-575_b305ec3a-6ecf-4f9b-9594-d28e4178e83f 68989-575 HUMAN OTC DRUG Happy Hands Foaming Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E On The Job, LLC BENZETHONIUM CHLORIDE 2 mg/mL 68990-001_af1ae44b-daee-435f-92f3-fc332e54f383 68990-001 HUMAN OTC DRUG SYS Octinoxate, Titanium Dioxide LOTION TOPICAL 20140601 OTC MONOGRAPH FINAL part352 AdvoCare International L.P. OCTINOXATE; TITANIUM DIOXIDE 3.75; 3 g/50mL; g/50mL 68991-001_0d52149c-7534-43f5-980c-9d17a88b9dd6 68991-001 HUMAN OTC DRUG KANG DU QING POLOXAMER 188 GEL VAGINAL 20110520 OTC MONOGRAPH NOT FINAL part333A Shenzhen Senton Science & Technology Co. Ltd POLOXAMER 188 2.7 g/100g 68994-1001_8355c4a6-f9a4-4ab1-9b46-92c09a7ec0fe 68994-1001 HUMAN OTC DRUG Hyundai Moolpas F METHYL SALICYLATE SOLUTION TRANSDERMAL 20140516 OTC MONOGRAPH NOT FINAL part348 Scott Holdings Co., Ltd. METHYL SALICYLATE 3 g/100mL 68994-2001_05999698-c1da-4f28-a82e-1ca80271eb8c 68994-2001 HUMAN OTC DRUG Bumooly-S METHYL SALICYLATE SOLUTION TRANSDERMAL 20140516 OTC MONOGRAPH NOT FINAL part348 Scott Holdings Co., Ltd. METHYL SALICYLATE 3 g/100mL 68994-3001_0ad679b4-61fd-4dbe-a4f4-14145f379aaf 68994-3001 HUMAN OTC DRUG Hyundai Moolpas F METHYL SALICYLATE SOLUTION TRANSDERMAL 20140925 OTC MONOGRAPH FINAL part348 Scott Holdings Co., Ltd. METHYL SALICYLATE 3 g/100mL 68994-4001_55447fd9-cf7d-4aa3-bc71-8663ced28016 68994-4001 HUMAN OTC DRUG Bumooly-S METHYL SALICYLATE SOLUTION TRANSDERMAL 20140925 OTC MONOGRAPH FINAL part348 Scott Holdings Co., Ltd. METHYL SALICYLATE 3 g/100mL 68998-311_f7e29886-158c-4431-8ac4-dc148e333d08 68998-311 HUMAN OTC DRUG Day Time Cold and Flu non drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 68998-343_65a71c83-e66d-4f99-99e8-4d709e21af2a 68998-343 HUMAN OTC DRUG Nighttime Cold and Flu cherry Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 68998-344_4311232f-ef13-4904-a661-0eb51bc9757e 68998-344 HUMAN OTC DRUG Nighttime Cold and Flu original Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL 68998-345_cccef4d4-7a5a-4cdf-9668-1c5f05cb282c 68998-345 HUMAN OTC DRUG Night Time Cough cherry Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL 68998-382_14e80c39-41ff-463e-a271-63b8e9508c4b 68998-382 HUMAN OTC DRUG Tussin CF Adult Multi Symptom Cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20140930 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 68998-385_f23837e9-e778-402c-bb0e-f83814ef262e 68998-385 HUMAN OTC DRUG Tussin DM Cough and Chest Congestion Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20141130 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 68999-626_4585502f-856f-4bc5-9ba3-2382ae42be94 68999-626 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 CHARTWELL GOVERNMENTAL & SPECIALTY RX LLC DOXYCYCLINE HYCLATE 100 mg/1 68999-984_6670b07b-76f9-4ed2-9626-01f4f59448fb 68999-984 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Chartwell Governmental and Specialty RX LLC DOXYCYCLINE HYCLATE 50 mg/1 68999-985_6670b07b-76f9-4ed2-9626-01f4f59448fb 68999-985 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Chartwell Governmental and Specialty RX LLC DOXYCYCLINE HYCLATE 100 mg/1 69000-010_4ca66249-7358-40b6-9ca8-778752bc2663 69000-010 HUMAN OTC DRUG Time Frame Future Resist Foundation Broad Spectrum SPF 20 Delilah Cosmetics Titanium Dioxide LIQUID TOPICAL 20141007 OTC MONOGRAPH FINAL part352 Delilah Cosmetics TITANIUM DIOXIDE 5 g/100mL 69000-011_5d037928-aadf-4be6-bade-7edf4470e799 69000-011 HUMAN OTC DRUG Time Frame Future Resist Foundation Broad Spectrum SPF 20 Delilah Cosmetics Avobenzone, Octinoxate, Octocrylene LIQUID TOPICAL 20141007 OTC MONOGRAPH FINAL part352 Delilah Cosmetics AVOBENZONE; OCTINOXATE; OCTOCRYLENE .6; 3; 3 g/100mL; g/100mL; g/100mL 69000-018_4bf8b28b-c965-46d7-9fab-94a8d3385769 69000-018 HUMAN OTC DRUG Shell Future Resist Foundation Broad Spectrum SPF 20 Delilah Titanium Dioxide LOTION TOPICAL 20141013 OTC MONOGRAPH FINAL part352 Delilah Cosmetics TITANIUM DIOXIDE 5 g/100mL 69000-019_dabe0091-4630-467a-955c-084ab2a2934e 69000-019 HUMAN OTC DRUG Lace Future Resist Broad Spectrum SPF 20 Foundation Delilah Titanium Dioxide LOTION TOPICAL 20141013 OTC MONOGRAPH FINAL part352 Delilah Cosmetics TITANIUM DIOXIDE 5 g/100mL 69000-020_9a173b1b-a2a6-49f0-8ad4-a41b32807103 69000-020 HUMAN OTC DRUG Buttermilk Future Resist Foundation Broad Spectrum SPF 20 Delilah Titanium Dioxide LOTION TOPICAL 20141013 OTC MONOGRAPH FINAL part352 Delilah Cosmetics TITANIUM DIOXIDE 5 g/100mL 69000-021_fb8c1c3b-6c42-4db9-b59e-d7ec934542c9 69000-021 HUMAN OTC DRUG Pebble Future Resist Foundation Broad Spectrum SPF 20 Foundation Delilah Titanium Dioxide LIQUID TOPICAL 20141013 OTC MONOGRAPH FINAL part352 Delilah Cosmetics TITANIUM DIOXIDE 5 g/100mL 69000-022_a47dd4a1-b86a-4b4a-80f6-48972c08795e 69000-022 HUMAN OTC DRUG Maple Future Resist Foundation Broad Spectrum SPF 20 Foundation Delilah Titanium Dioxide LIQUID TOPICAL 20141013 OTC MONOGRAPH FINAL part352 Delilah Cosmetics TITANIUM DIOXIDE 5 g/100mL 69000-023_0dab3b97-9e75-4b21-afb6-c63c17582401 69000-023 HUMAN OTC DRUG Nutmeg Future Resist Foundation Broad Spectrum SPF 20 Foundation Delilah Titanium Dioxide LIQUID TOPICAL 20141013 OTC MONOGRAPH FINAL part352 Delilah Cosmetics TITANIUM DIOXIDE 5 g/100mL 69000-024_eb57be5d-1580-42f7-9a03-9cdd75c3b174 69000-024 HUMAN OTC DRUG Chestnut Future Resist Foundation Broad Spectrum Foundation Delilah Titanium Dioxide LIQUID TOPICAL 20141013 OTC MONOGRAPH FINAL part352 Delilah Cosmetics TITANIUM DIOXIDE 5 g/100mL 69003-412_385aafba-7dda-490b-b86f-afaf1bb79e29 69003-412 HUMAN OTC DRUG Naruko Taiwan Magnolia Firming Smooth Finish Cream Makeup Ethylhexyl Methoxycinnamate, Octocrylene, Zinc Oxide CREAM TOPICAL 20140514 OTC MONOGRAPH FINAL part352 Beauty Essentials Limited, Taiwan Branch OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 7.65; 3.08; 3.04 g/100g; g/100g; g/100g 69004-001_11fbeca7-3726-47e2-8cf4-d9cd9e307571 69004-001 HUMAN OTC DRUG GPS Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Group Practice Solutions, Inc. BENZOCAINE 200 mg/g 69004-002_6a32dfdd-d6c1-4b25-8bc2-43449afba71a 69004-002 HUMAN OTC DRUG GPS Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Group Practice Solutions, Inc. BENZOCAINE 200 mg/g 69004-003_6e5c6371-b8e5-4cea-9861-1e6030ab81ed 69004-003 HUMAN OTC DRUG GPS Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Group Practice Solutions, Inc. BENZOCAINE 200 mg/g 69004-004_60af33f2-0eb1-47e8-9f15-40cd86060e40 69004-004 HUMAN OTC DRUG GPS Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Group Practice Solutions, Inc. BENZOCAINE 200 mg/g 69004-005_5257f1ed-3ac9-4655-ad31-5e039ff9e518 69004-005 HUMAN OTC DRUG GPS Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Group Practice Solutions, Inc. BENZOCAINE 200 mg/g 69004-006_7d5e7715-7c65-4a2b-9d43-2fba7d662499 69004-006 HUMAN OTC DRUG GPS Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Group Practice Solutions, Inc. BENZOCAINE 200 mg/g 69006-001_613bfe26-b0be-4a3a-bef9-ee248d423879 69006-001 HUMAN OTC DRUG TetraStem TETRACYCLINE HYDROCHLORIDE OINTMENT TOPICAL 20140528 OTC MONOGRAPH FINAL part333B VIADERMA II, INC. TETRACYCLINE HYDROCHLORIDE 30 mg/g 69007-765_2e1e6952-44a0-41fa-83c5-5c4b9aecdb2d 69007-765 HUMAN PRESCRIPTION DRUG desonide desonide LOTION TOPICAL 19841214 NDA AUTHORIZED GENERIC NDA019048 Owen Laboratories, Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 69007-770_2e1e6952-44a0-41fa-83c5-5c4b9aecdb2d 69007-770 HUMAN PRESCRIPTION DRUG desonide desonide CREAM TOPICAL 19841214 NDA AUTHORIZED GENERIC NDA019048 Owen Laboratories, Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 69007-822_879483a3-93ed-4ef3-bf68-197ca9ebfbd2 69007-822 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE CAPSULE, DELAYED RELEASE ORAL 20100514 NDA AUTHORIZED GENERIC NDA050805 Owen Laboratories, Inc. DOXYCYCLINE 40 mg/1 69007-912_37259cdb-ed05-4e36-9ff6-e67b41cad7d7 69007-912 HUMAN PRESCRIPTION DRUG adapalene adapalene LOTION TOPICAL 20100331 NDA AUTHORIZED GENERIC NDA022502 Owen Laboratories, Inc. ADAPALENE .1 g/100mL Retinoid [EPC],Retinoids [Chemical/Ingredient] 69007-918_33e7f83d-6987-4d72-9606-b2814f92d664 69007-918 HUMAN PRESCRIPTION DRUG adapalene adapalene GEL TOPICAL 20090915 NDA AUTHORIZED GENERIC NDA021753 Owen Laboratories, Inc. ADAPALENE 3 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 69013-001_b956e2e1-999a-47ac-bcc0-ec248e7a3851 69013-001 HUMAN OTC DRUG Always Triple BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Elishacoy Co., Inc. TITANIUM DIOXIDE; ZINC OXIDE 5; .5 g/50g; g/50g 69013-002_b704a7f9-e572-49ac-9083-8bb2c29e5dc1 69013-002 HUMAN OTC DRUG Premium Gold Mineral BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140528 OTC MONOGRAPH FINAL part352 Elishacoy Co., Inc. TITANIUM DIOXIDE; ZINC OXIDE 5; 3 g/50g; g/50g 69013-003_d04d33fe-55f8-41dd-ae9d-88ed636e1d57 69013-003 HUMAN OTC DRUG Time Machine BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140528 OTC MONOGRAPH FINAL part352 Elishacoy Co., Inc. TITANIUM DIOXIDE; ZINC OXIDE 3; 2 g/30g; g/30g 69013-004_b8ca76a3-adab-4ff9-a376-fa6e5a5250a2 69013-004 HUMAN OTC DRUG Always Nuddy CC Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140528 OTC MONOGRAPH FINAL part352 Elishacoy Co., Inc. TITANIUM DIOXIDE; ZINC OXIDE 4; 1 g/50g; g/50g 69013-005_a5111aeb-fd1d-4219-a95a-d1b818075562 69013-005 HUMAN OTC DRUG Always Perfect CC Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140529 OTC MONOGRAPH FINAL part352 Elishacoy Co., Inc. TITANIUM DIOXIDE; ZINC OXIDE 5; 3 g/50g; g/50g 69015-100_b0101700-c3ac-4ed0-8eaf-06b8deca2dd5 69015-100 HUMAN OTC DRUG ULTIMATE AQUA BLANC PROTECTIVE OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE LOTION TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 Racinne (Hong Kong) Limited AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 1.5; 3.75; 2.5; 2 mg/50mL; mg/50mL; mg/50mL; mg/50mL 69015-110_b3bf2015-0b08-46a0-b3ab-87a80e952f12 69015-110 HUMAN OTC DRUG ULTIMATE AQUA BLANC PROTECTIVE 10mL OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE LOTION TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 Racinne (Hong Kong) Limited AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .3; .75; .5; .4 mg/10mL; mg/10mL; mg/10mL; mg/10mL 69016-001_e6cff231-ba97-4016-ab47-323461fb6d70 69016-001 HUMAN OTC DRUG Relief OTC antacid CALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE LIQUID ORAL 20140528 OTC MONOGRAPH FINAL part331 Tummy Company, Inc. CALCIUM CARBONATE; POTASSIUM BICARBONATE; SODIUM BICARBONATE 545; 905; 2110 mg/118mL; mg/118mL; mg/118mL 69017-101_360b982c-9eb0-499b-abf9-6b4cc9c62f09 69017-101 HUMAN OTC DRUG ANTI-BLEMISH MATTE PRIMER SALICLYLIC ACID LOTION TOPICAL 20140101 OTC MONOGRAPH FINAL part333D Jouer Cosmetics LLC SALICYLIC ACID 1 mg/100mL 69017-101_b8bbedb2-be19-4c9a-a470-93422c8dbcda 69017-101 HUMAN OTC DRUG ANTI-BLEMISH MATTE PRIMER SALICLYLIC ACID LOTION TOPICAL 20140101 OTC MONOGRAPH FINAL part333D Jouer Cosmetics LLC SALICYLIC ACID 1 mg/100mL 69017-201_a8d1361d-9081-4c4e-8fa7-41d6aa0026a4 69017-201 HUMAN OTC DRUG MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 HAZEL ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 3 mg/100mL; mg/100mL 69017-202_8ced08a3-bb4f-4e59-a556-2b95f02c4a21 69017-202 HUMAN OTC DRUG MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 Nude ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 3 mg/100mL; mg/100mL 69017-203_9717e234-8533-4745-8582-f68ff372542f 69017-203 HUMAN OTC DRUG MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 BEIGE ROSE ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 3 mg/100mL; mg/100mL 69017-204_fe1cd8a0-3812-45f0-a099-12d19b738827 69017-204 HUMAN OTC DRUG MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 CHAMOMILE ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 3 mg/100mL; mg/100mL 69017-205_d1dcd94a-a0dc-4db0-9b21-d0a7f0ec475d 69017-205 HUMAN OTC DRUG MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 Linen ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 3 mg/100mL; mg/100mL 69017-206_76041780-8991-45b2-8b30-cd0c3f18689d 69017-206 HUMAN OTC DRUG MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 Porcelain ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 3 mg/100mL; mg/100mL 69017-301_361d845a-1901-4979-bb3f-3a6d2916c072 69017-301 HUMAN OTC DRUG LUMINIZING MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 20 BLUSH ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 5 mg/100mL; mg/100mL 69017-302_e198612f-3274-4e11-993f-892f7858f254 69017-302 HUMAN OTC DRUG LUMINIZING MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 20 BRONZED ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 5 mg/100mL; mg/100mL 69017-303_93320269-96df-43ee-b7d2-1551c9e253f8 69017-303 HUMAN OTC DRUG LUMINIZING MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 20 DEEP BRONZE ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 5 mg/100mL; mg/100mL 69017-304_629ee131-8f57-45ce-8778-50aa7d5d4cb7 69017-304 HUMAN OTC DRUG LUMINIZING MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 20 GLOW ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 5 mg/100mL; mg/100mL 69017-305_be7c3616-4e6d-4bad-a81d-09df69173732 69017-305 HUMAN OTC DRUG LUMINIZING MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 20 GOLDEN ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 5 mg/100mL; mg/100mL 69017-306_1a4ad9e0-97ea-4c58-9809-0b3be84dd05c 69017-306 HUMAN OTC DRUG LUMINIZING MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 20 OPAL ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 5 mg/100mL; mg/100mL 69017-307_574ab28c-41dd-42ad-a8ad-d5f462adc340 69017-307 HUMAN OTC DRUG LUMINIZING MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 20 PEARL ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 5 mg/100mL; mg/100mL 69020-200_35287aa1-48f4-48fd-9ec2-39971c02c56f 69020-200 HUMAN OTC DRUG MakeSense Extra Strength Muscle Rub Menthol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part348 Cherry Hill Sales Co MENTHOL 2.5 g/100g 69020-201_675f8ce3-c1dc-4767-9156-69cd0a805cf9 69020-201 HUMAN OTC DRUG MAKESENSE with Aloe Vera and Vitamin E Camphor Menthol CREAM TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part348 Cherry Hill Sales Co CAMPHOR (SYNTHETIC); MENTHOL 1; 1 g/100g; g/100g 69020-202_278b82f7-db0d-4be1-8a3b-21909a937103 69020-202 HUMAN OTC DRUG MAKESENSE First Aid Bacitracin Zinc Neomycin Polymyxin B Sulfate OINTMENT TOPICAL 20140615 OTC MONOGRAPH FINAL part333B Cherry Hill Sales Co BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 69020-203_732c95f3-363c-432c-95b5-0f2507191dca 69020-203 HUMAN OTC DRUG MakeSense Clotrimazole CREAM TOPICAL 20140615 OTC MONOGRAPH FINAL part333C Cherry Hill Sales Co CLOTRIMAZOLE 1 g/100g 69020-204_b3eab8bc-a307-43c4-9691-6541b7e3646d 69020-204 HUMAN OTC DRUG MAKESENSE MAXIMUM STRENGTH Hydrocortisone CREAM TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part348 Cherry Hill Sales Co HYDROCORTISONE 1 g/100g 69020-205_08a315bb-41c8-4cc9-9754-ec3b3bb5e7d7 69020-205 HUMAN OTC DRUG MAKESENSE Phenylephrine Hydrochloride Zinc oxide CREAM TOPICAL 20140731 OTC MONOGRAPH FINAL part346 Cherry Hill Sales Co PHENYLEPHRINE HYDROCHLORIDE; ZINC OXIDE .25; 12.5 g/100g; g/100g 69020-206_90caa440-ee24-40b9-9ea6-6e4003469c8c 69020-206 HUMAN OTC DRUG MAKESENSE Junior Pain Relief Benzocaine GEL TOPICAL 20140715 OTC MONOGRAPH NOT FINAL part356 Cherry Hill Sales Co BENZOCAINE 7.5 g/100g 69020-207_dbb2fffb-9c0c-4df5-ac7e-b15a9f83e28a 69020-207 HUMAN OTC DRUG MAKESENSE Pain Relief Benzocaine GEL TOPICAL 20140715 OTC MONOGRAPH NOT FINAL part356 Cherry Hill Sales Co BENZOCAINE 20 g/100g 69020-208_cd1f86f8-255a-480e-bc47-1cb177465eb8 69020-208 HUMAN OTC DRUG MakeSense Miconazole CREAM TOPICAL 20140715 OTC MONOGRAPH FINAL part333C Cherry Hill Sales Co MICONAZOLE NITRATE 2 g/100g 69020-209_46674f2f-860b-44b2-8f74-75b9d9956d04 69020-209 HUMAN OTC DRUG MakeSense Feminine Anti-itch Benzocaine Benzalkonium chloride CREAM TOPICAL 20140731 OTC MONOGRAPH NOT FINAL part348 Cherry Hill Sales Co BENZALKONIUM CHLORIDE; BENZOCAINE 130; 5 mg/100g; g/100g 69020-210_b0528b58-df31-46c8-8b0b-b3bf03d0480e 69020-210 HUMAN OTC DRUG MAKESENSE First Aid Lidocaine Hydrochloride Phenol CREAM TOPICAL 20140731 OTC MONOGRAPH NOT FINAL part333E Cherry Hill Sales Co LIDOCAINE HYDROCHLORIDE ANHYDROUS; PHENOL .5; .5 g/100g; g/100g 69022-001_d72dfb3d-666b-48c0-a674-b7bf5ea65174 69022-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140601 UNAPPROVED MEDICAL GAS American Home Medical Equipment and Services, Inc. OXYGEN 99 L/100L 69023-100_5ac0eadd-ce2d-47df-9f86-9513defd288e 69023-100 HUMAN OTC DRUG One Gel Sport Pain relieving Camphor (Synthetic) and Menthol GEL TOPICAL 20140704 OTC MONOGRAPH NOT FINAL part348 Phyto Creativ CAMPHOR (SYNTHETIC); MENTHOL 30; 22 mg/mL; mg/mL 69024-001_0b235482-1c2b-4543-a887-fa6222e523d9 69024-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140601 UNAPPROVED MEDICAL GAS OxyPros Plus OXYGEN 99 L/100L 69026-253_b5345439-9273-449c-b6c1-e17623559da2 69026-253 HUMAN OTC DRUG Beauty Counter Protect All over Sunscreen SPF30 Zinc Oxide EMULSION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 Counter Brands LLC ZINC OXIDE 19 g/100mL 69028-0001_e8feaaa2-329c-3a53-b52b-8e51dc3c8fab 69028-0001 HUMAN PRESCRIPTION DRUG Drainage Carduus mar., Cynara, Solidago, Taraxacum, Benzoicum ac., Berberis vulg., Bryonia, Cantharis, Carduus ben., Ceanothus, Chelidonium maj., Chionanthus. Cinchona, Dioscorea, Dolichos, Iris vers., Juniperus com., Nux vom., Ptelea, Uricum ac. LIQUID ORAL 20140929 UNAPPROVED HOMEOPATHIC Xymogen BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; DIOSCOREA VILLOSA TUBER; IRIS VERSICOLOR ROOT; JUNIPER BERRY; LYTTA VESICATORIA; MUCUNA PRURIENS FRUIT TRICHOME; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; URIC ACID 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 15; 15; 3; 3; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] 69031-001_b2f2b1d6-3d9d-45a5-9424-b68c75086dd2 69031-001 HUMAN OTC DRUG Soothix Acne Treatment and Blemish Prevention Formula Salicylic Acid LOTION TOPICAL 20140717 OTC MONOGRAPH FINAL part333D Electrolyzed Innovations, LLC SALICYLIC ACID 1 g/100g 69031-002_ed7ff357-4b60-4115-a1bb-ef997b2df236 69031-002 HUMAN OTC DRUG Soothix Antiseptic Hand Sanitizing Benzalkonium chlroide LOTION TOPICAL 20140717 OTC MONOGRAPH NOT FINAL part333A Electrolyzed Innovations, LLC BENZALKONIUM CHLORIDE .13 g/100g 69031-003_28d1670c-f73b-47f3-a55b-5918ba264efd 69031-003 HUMAN OTC DRUG Soothix Psoriasis and Seborrheic Dermatitis Formula Salicylic Acid LOTION TOPICAL 20140717 OTC MONOGRAPH FINAL part358H Electrolyzed Innovations, LLC SALICYLIC ACID 2 g/100g 69033-001_22754c5b-532a-484c-9a61-50226d9d6767 69033-001 HUMAN OTC DRUG La mer Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20140606 OTC MONOGRAPH NOT FINAL part333E Five Star Beach Properties ALCOHOL 62 mL/100mL 69034-001_8bc84124-769f-4436-8827-e7cdaa83b342 69034-001 HUMAN OTC DRUG kiwi crate Liquid Hand Triclosan SOAP TOPICAL 20140606 OTC MONOGRAPH NOT FINAL part333E Kiwi Crate TRICLOSAN .3 g/100mL 69036-098_949bb4f0-f6c7-4a16-99c3-8f177174adaf 69036-098 HUMAN PRESCRIPTION DRUG Captracin Menthol and Capsaicin PATCH TOPICAL 20141201 UNAPPROVED DRUG OTHER Sallus Laboratories, LLC CAPSAICIN; MENTHOL, UNSPECIFIED FORM .0375; 5 g/1; g/1 69036-110_67df3c55-a2b0-4185-8a0d-18754cdae920 69036-110 HUMAN OTC DRUG LORTUSS LQ Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID ORAL 20140801 OTC MONOGRAPH FINAL part341 Sallus Laboratories, LLC DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 6.25; 30 mg/5mL; mg/5mL 69036-120_41999ae8-18fc-49a0-a55c-ffa00f353ddd 69036-120 HUMAN OTC DRUG LORTUSS DM Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID ORAL 20140614 OTC MONOGRAPH FINAL part341 Sallus Laboratories, LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 15; 6.25; 30 mg/5mL; mg/5mL; mg/5mL 69036-130_ec543c14-8427-4659-bcc0-3cdcd149ba81 69036-130 HUMAN OTC DRUG LORTUSS EX Codeine Phosphate, Guaifenesin, Pseudoephedrine Hydrochloride LIQUID ORAL 20140601 OTC MONOGRAPH FINAL part341 Sallus Laboratories, LLC CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 100; 30 mg/5mL; mg/5mL; mg/5mL CV 69038-001_9ae3d963-c738-44a7-a097-17dc629eb335 69038-001 HUMAN OTC DRUG BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 FAIR 01 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; TITANIUM DIOXIDE 60; 20 mg/mL; mg/mL 69038-002_10b0193f-ab85-4dfa-a7e4-3f09aa14a486 69038-002 HUMAN OTC DRUG BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 MEDIUM 02 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; TITANIUM DIOXIDE 60; 20 mg/mL; mg/mL 69038-003_7a663802-c4ed-4d24-bfa5-fe1e9d76a3d2 69038-003 HUMAN OTC DRUG BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 DARK 03 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; TITANIUM DIOXIDE 60; 20 mg/mL; mg/mL 69038-004_d234c21b-640c-4d7b-b5e2-d97be003127d 69038-004 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Almond No. 43 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL 69038-005_a03cd781-67e9-4dda-94e7-a89eb78e2ad8 69038-005 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Beige No. 26 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL 69038-006_60e66bac-69c8-4266-8787-d600e59fec30 69038-006 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Camel No. 42 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL 69038-007_4f3c3c4f-0888-4a53-90d2-4eb2442a7c08 69038-007 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Chestnut No. 60 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL 69038-008_2e527705-27c8-4667-b419-a7f866d1fca1 69038-008 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Dark Sable No. 36 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL 69038-009_833d27cb-aecc-4f21-9d3c-c558b7ca6281 69038-009 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Deep Brown No. 66 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL 69038-010_c6ee91b8-6563-4834-817a-a9899d52ea00 69038-010 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Honey No. 32 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL 69038-011_65e09c05-c632-44a8-81d6-fbeed5b866d8 69038-011 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Mocha No. 64 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL 69038-012_28468317-522c-4dcc-9662-e326d4c02ad0 69038-012 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Ochre No. 20 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL 69038-013_4646cfa5-2ab5-4d0c-93bc-23bfef5bb9b3 69038-013 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Ochre Nude No. 12 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL 69038-014_7f16052d-54ea-47ea-8617-43c10d35557d 69038-014 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Porcelain No. 11 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL 69038-015_e2b40120-8b12-4e66-815b-32163b003ad1 69038-015 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Rosy Nude No. 31 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL 69038-016_fd6bb99a-048e-4ebe-a666-bd5f7edc6323 69038-016 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Warm Honey No. 38 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL 69038-017_3bfc5020-0db0-43ec-95bf-bd6179ef960f 69038-017 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Warm Nude No. 34 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL 69039-101_5221e564-48c7-4405-b07b-d0da2e1d29b3 69039-101 HUMAN OTC DRUG Natural Sunscreen Broad Spectrum SPF 30 Baby Bum Zinc Oxide LOTION TOPICAL 20140626 OTC MONOGRAPH FINAL part352 Sun Bum LLC ZINC OXIDE 22 g/100mL 69039-102_7bea8f85-15a3-4a30-bc2b-7f240e2588b3 69039-102 HUMAN OTC DRUG Sunscreen Stick Broad Spectrum SPF 30 Sunscreen baby Bum Zinc Oxide STICK TOPICAL 20140628 OTC MONOGRAPH FINAL part352 Sun Bum LLC ZINC OXIDE 20 g/100g 69041-001_056039eb-7412-41a3-9ec6-9ef721379648 69041-001 HUMAN OTC DRUG Polyethylene Glycol (3350) polyethylene glycol (3350) POWDER, FOR SOLUTION ORAL 20140924 ANDA ANDA091077 CRH Medical Corporation POLYETHYLENE GLYCOL 3500 17 g/17g 69041-002_0283e6fb-63e4-4fb5-ae0d-1004e2335f59 69041-002 HUMAN OTC DRUG CRH Medsense Bisacodyl Stimulant Laxative Bisacodyl TABLET, COATED ORAL 20140925 OTC MONOGRAPH NOT FINAL part334 CRH Medical Corporation BISACODYL 5 mg/1 69041-003_48bf96f6-76d6-499e-a751-5a9cf4922b94 69041-003 HUMAN OTC DRUG Magnesium Citrate Saline Laxative MAGNESIUM CITRATE POWDER, FOR SOLUTION ORAL 20140925 OTC MONOGRAPH NOT FINAL part334 CRH Medical Corporation MAGNESIUM CITRATE 17 g/17g 69041-004_517df872-366c-4822-a86e-a4593e0b63e3 69041-004 HUMAN OTC DRUG CRH Medsense Simethicone 125mg Antigas Simethicone CAPSULE, LIQUID FILLED ORAL 20110912 OTC MONOGRAPH FINAL part332 CRH Medical Corporation DIMETHICONE 125 mg/1 69043-001_79975c20-b9d8-4e26-a2a4-a7685f3a8c07 69043-001 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Cronus Pharma LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 69043-002_79975c20-b9d8-4e26-a2a4-a7685f3a8c07 69043-002 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Cronus Pharma LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 69043-003_79975c20-b9d8-4e26-a2a4-a7685f3a8c07 69043-003 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Cronus Pharma LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 69044-123_249c55d1-b693-4466-93f8-12f3835fde4c 69044-123 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20140612 UNAPPROVED MEDICAL GAS OXYGEN UTAH OXYGEN 210 mL/L 69047-001_11f4dd9c-4dc1-41b9-be80-220568b72e45 69047-001 HUMAN OTC DRUG Youth Cell Day Cream Broad Spectrum SPF-15 Sunscreen (50 ml) SPF 15 Cream CREAM TOPICAL 20131016 OTC MONOGRAPH FINAL part352 Iluminage Beauty, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 5.994; 3; 2.4 mg/100mL; mg/100mL; mg/100mL; mg/100mL 69053-008_60c70d4b-2bb6-4fe4-a1ac-2758c6bc3111 69053-008 HUMAN PRESCRIPTION DRUG Ephedrine Sulfate Ephedrine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20141101 UNAPPROVED DRUG OTHER Andersen Pharma LLC EPHEDRINE SULFATE 50 mg/mL 69054-210_41bc18d9-9498-41c4-b84e-5bb6d2d52543 69054-210 HUMAN PRESCRIPTION DRUG Ocuvel Ocuvel CAPSULE ORAL 20141105 UNAPPROVED DRUG OTHER Adler-Stern Pharmaceuticals, LLC ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; COPPER; FOLIC ACID; LUTEIN; ZEAXANTHIN; ZINC OXIDE 400; 500; 2; 1; 10; 2; 80 [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 69054-211_856ddba0-ef2e-43d7-bde6-682c15a5086a 69054-211 HUMAN PRESCRIPTION DRUG Ocuvel Ocuvel CAPSULE ORAL 20141201 UNAPPROVED DRUG OTHER Adler-Stern Pharmaceuticals, LLC ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; COPPER; FOLIC ACID; LUTEIN; ZEAXANTHIN; ZINC OXIDE 200; 250; 1; .5; 5; 1; 40 [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 69054-220_9d69df78-e2e6-4a9a-a06e-bb91754da440 69054-220 HUMAN PRESCRIPTION DRUG Ciferex Ciferex CAPSULE ORAL 20141111 UNAPPROVED DRUG OTHER Adler-Stern Pharmaceuticals, LLC CHOLECALCIFEROL; FOLIC ACID 3775; 1 [iU]/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 69054-231_e0017329-4705-4120-b003-9a4242163c22 69054-231 HUMAN PRESCRIPTION DRUG LIDOPIN Lidocaine Hydrochloride CREAM TOPICAL 20141111 UNAPPROVED DRUG OTHER Adler-Stern Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE ANHYDROUS 32.5 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 69054-500_3b07cf01-09e8-462a-925a-18be35e3f7f3 69054-500 HUMAN PRESCRIPTION DRUG Zeruvia Lidocaine Hydrochloride and Menthol PATCH TOPICAL 20141114 UNAPPROVED DRUG OTHER Adler-Stern Pharmaceuticals,LLC LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 69061-101_b341f1e2-214f-4db6-8129-f5c07fe05afa 69061-101 HUMAN OTC DRUG FUNGUS MD TOLNAFTATE LIQUID TOPICAL 20140718 OTC MONOGRAPH FINAL part333C Orly International Inc TOLNAFTATE 1 g/100mL 69065-001_24aa1424-21f1-465e-a047-84ab3569b959 69065-001 HUMAN OTC DRUG Gadis Lip Moisturizer SPF15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140806 OTC MONOGRAPH NOT FINAL part352 Gadis Ingenious Gadgets Inc. OCTINOXATE; OXYBENZONE 7; 3 g/100g; g/100g 69069-101_0a928e3a-3508-4ef7-9057-536274aa91b7 69069-101 HUMAN OTC DRUG INFINITE ALOE ALL-IN-ONE SKIN CARE ALLANTOIN, COLLOIDAL OATMEAL LOTION TOPICAL 20140701 OTC MONOGRAPH FINAL part347 Economical Solutions, Inc. (DBA INFINITE ALOE) ALLANTOIN; OATMEAL .5; .07 g/100mL; g/100mL 69072-010_a08f95b5-ff62-42e9-96a9-3416122b27aa 69072-010 HUMAN OTC DRUG MOIST MOISTURE BB Titanium Dioxide, Zinc Oxide, OCTINOXATE CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SEINDNI CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.5; 3.5; 3.5 mg/50mL; mg/50mL; mg/50mL 69072-020_3a69a0a2-0616-4bac-97f3-bfa992d262a2 69072-020 HUMAN OTC DRUG MOIST MOISTURE CC OCTINOXATE, Titanium Dioxide, OCTISALATE CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SEINDNI CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 2.01; .75; 1.26 mg/30mL; mg/30mL; mg/30mL 69072-030_28218ed9-e7b2-4085-872a-c98253595931 69072-030 HUMAN OTC DRUG O2 Bubble Pack Wash Dimethicone LIQUID TOPICAL 20140601 OTC MONOGRAPH FINAL part347 SEINDNI CO., LTD. DIMETHICONE 1 mg/100mL 69072-040_d4c971f5-7975-4c26-aa43-594a7ff868b8 69072-040 HUMAN OTC DRUG MOIST MOISTURE Dimethicone CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 SEINDNI CO., LTD. DIMETHICONE 3 mg/300mL 69072-050_bcba3d1d-4499-4abc-9b81-85267e8d15f7 69072-050 HUMAN OTC DRUG MOIST MOISTURE EYE Dimethicone CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 SEINDNI CO., LTD. DIMETHICONE .35 g/35g 69072-060_cf0ec5a4-c021-49ea-ae13-d3e0ff89c1c3 69072-060 HUMAN OTC DRUG MOIST MOISTURE ESSENCE FACE MASK Dimethicone PATCH TOPICAL 20140601 OTC MONOGRAPH FINAL part347 SEINDNI CO., LTD. DIMETHICONE .22 mg/22mL 69072-070_d0b64b13-0efb-4f06-9c27-2f3a16bf8418 69072-070 HUMAN OTC DRUG askinDr MOIST MOISTURE Dimethicone CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 SEINDNI CO., LTD. DIMETHICONE .6 mg/60g 69072-080_19fa1cec-fc91-4b53-94f9-5ab2e381526a 69072-080 HUMAN OTC DRUG MOIST MOISTURE SKIN TONER Dimethicone CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 SEINDNI CO., LTD. DIMETHICONE 2 mg/200mL 69072-090_5945b7a3-9546-41c3-bdee-224d48958e61 69072-090 HUMAN OTC DRUG MOIST MOISTURE EMULSION Dimethicone CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 SEINDNI CO., LTD. DIMETHICONE 2 mg/200mL 69072-100_5f12105a-b7ad-402c-bbf3-c5882f039ffc 69072-100 HUMAN OTC DRUG HYALURONIC ACID COLLAGEN ESSENCE MASK Dimethicone PATCH TOPICAL 20140601 OTC MONOGRAPH FINAL part347 SEINDNI CO., LTD. DIMETHICONE .22 mg/22mL 69075-001_58656d15-4108-4598-9f78-4e06afff02cc 69075-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140801 UNAPPROVED MEDICAL GAS VirtAir Inc. OXYGEN 990 mL/L 69077-101_8c6dba80-1cb5-4448-b9d3-531da8aabf24 69077-101 HUMAN OTC DRUG SILKEN HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140628 OTC MONOGRAPH NOT FINAL part333E COSMOBEAUTI LABORATORIES & MANUFACTURING, INC. ALCOHOL 62 mL/100mL 69078-101_8af0c0e2-58c9-495d-93e8-167d5dc909ab 69078-101 HUMAN OTC DRUG LACURA FACE CARE Q10 DAY SPF-15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20141212 OTC MONOGRAPH FINAL part352 MAXIM Markenprodukte GmbH & Co. KG AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 8; 4; 1.5 g/100g; g/100g; g/100g; g/100g 69081-002_7fe5540d-43bd-41de-8320-d56f6db5bd32 69081-002 HUMAN OTC DRUG Gloves in a Bottle with SPF15 Octinoxate, octisalate, homosalate LOTION TOPICAL 20140707 OTC MONOGRAPH FINAL part352 Gloves in a Bottle, Inc HOMOSALATE; OCTINOXATE; OCTISALATE .03; .07; .05 g/g; g/g; g/g 69082-400_dde8b71f-5d01-44e7-b306-456b8eed6b67 69082-400 HUMAN OTC DRUG BAC-D Antibacterial Wound sanitizer Benzalkonium Chloride SPRAY TOPICAL 20140812 OTC MONOGRAPH NOT FINAL part333A RDM Products, Inc BENZALKONIUM CHLORIDE .13 g/100mL 69082-500_57ab099d-59de-410a-a37a-a1875d30589d 69082-500 HUMAN OTC DRUG BAC-D Antibacterial Wound and Skin care Benzalkonium Chloride SPRAY TOPICAL 20140812 OTC MONOGRAPH NOT FINAL part333A RDM Products, Inc BENZALKONIUM CHLORIDE .13 g/100mL 69082-500_8d29cf1e-1078-40c0-8010-7aca9998c496 69082-500 HUMAN OTC DRUG BAC-D Antibacterial Wound and Skin care Benzalkonium Chloride SPRAY TOPICAL 20140812 OTC MONOGRAPH NOT FINAL part333A RDM Products, Inc BENZALKONIUM CHLORIDE .13 g/100mL 69082-600_d78da8c8-5203-4a22-a275-96ba6f6386d7 69082-600 HUMAN OTC DRUG BAC-D Foaming Antibacterial Hand sanitizer Benzalkonium Chloride LIQUID TOPICAL 20140812 OTC MONOGRAPH NOT FINAL part333A RDM Products, Inc BENZALKONIUM CHLORIDE .13 g/100mL 69082-700_f8e637df-3520-485d-9740-7c3e806592b3 69082-700 HUMAN OTC DRUG BAC-D Foaming Antibacterial Wound sanitizer Benzalkonium Chloride LIQUID TOPICAL 20140812 OTC MONOGRAPH NOT FINAL part333A RDM Products, Inc BENZALKONIUM CHLORIDE .13 g/100mL 69083-101_1ee3b02a-39cd-4bbf-a295-3fed9a697a36 69083-101 HUMAN OTC DRUG Seldicine (Massage Cream) CAMPHOR, MENTHOL CREAM TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part348 Orye Life Science Co., Ltd. CAMPHOR OIL; MENTHOL 1; 1 g/100g; g/100g 69086-1001_6b5ead19-c310-46f4-a237-013c4de4017d 69086-1001 HUMAN OTC DRUG Sensible SODIUM LAURYL SULFATE PASTE DENTAL 20140711 OTC MONOGRAPH NOT FINAL part356 Guardian Angel of Preventive Dentistry SODIUM LAURYL SULFATE 2 g/100g 69088-101_aa6acc09-9ee0-445a-8d1c-63904bff94fa 69088-101 HUMAN OTC DRUG Personal Wash Cloths Benzalkonium chloride CLOTH TOPICAL 20140714 OTC MONOGRAPH NOT FINAL part333A Leading Age Supplies BENZALKONIUM CHLORIDE .0155 g/1 69089-101_1ae3422d-9b8e-4297-8ecd-bd0655a5e62f 69089-101 HUMAN OTC DRUG Personal Wash Cloths Benzalkonium chloride CLOTH TOPICAL 20140714 OTC MONOGRAPH NOT FINAL part333A Ginni Filaments Limited BENZALKONIUM CHLORIDE .0155 g/1 69090-0100_befbb401-5456-4e1b-82a6-8408f307d36e 69090-0100 HUMAN OTC DRUG SPF-30 BB Zinc Oxide LOTION TOPICAL 20140120 OTC MONOGRAPH FINAL part352 ZION HEALTH ZINC OXIDE 20 g/100mL 69092-001_c6248bef-a477-465f-a1ba-023dc55a6c29 69092-001 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part333E Matrix Source USA, Inc ALCOHOL 62 mL/100mL 69093-1001_af6bc443-664b-4fbc-878b-bc1a724eeb7d 69093-1001 HUMAN OTC DRUG Flex Power Cream GLYCERIN CREAM TOPICAL 20140703 OTC MONOGRAPH FINAL part347 FLEX-POWER KOREA INC GLYCERIN 4 g/100mL 69094-226_c73ebe35-33bd-45b0-8a20-fbec28f278a1 69094-226 HUMAN OTC DRUG 1st RELIEF TOPICAL LIDOCAINE AND MENTHOL SPRAY TOPICAL 20141202 OTC MONOGRAPH NOT FINAL part348 1st Class Pharmaceuticals, Inc. LIDOCAINE; MENTHOL 40; 10 mg/mL; mg/mL 69096-0100_1a5917aa-cddd-4225-b2df-f9e177533c0e 69096-0100 HUMAN OTC DRUG Linea Jose Ignacio Sunscreen Broad Spectrum SPF30 Avobenzone, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20121210 OTC MONOGRAPH FINAL part352 Linea Jose Ignacio AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 15; 75; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL 69097-112_93618003-21c5-4b03-a565-329c56f3c82c 69097-112 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET ORAL 20141120 ANDA ANDA077335 Cipla USA Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 69097-122_ae861424-3168-4d83-a591-94b18ce1e1b4 69097-122 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Cipla USA Inc. TOPIRAMATE 25 meq/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 69097-123_ae861424-3168-4d83-a591-94b18ce1e1b4 69097-123 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Cipla USA Inc. TOPIRAMATE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 69097-124_ae861424-3168-4d83-a591-94b18ce1e1b4 69097-124 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Cipla USA Inc. TOPIRAMATE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 69097-125_ae861424-3168-4d83-a591-94b18ce1e1b4 69097-125 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Cipla USA Inc. TOPIRAMATE 200 1/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 69097-126_8e9a1a44-678c-4422-99d4-d0847248bd8e 69097-126 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 Cipla USA Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 69097-127_8e9a1a44-678c-4422-99d4-d0847248bd8e 69097-127 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 Cipla USA Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 69097-128_8e9a1a44-678c-4422-99d4-d0847248bd8e 69097-128 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 Cipla USA Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 69097-148_23558714-cd2c-4bd8-961b-303c15241dde 69097-148 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20101101 ANDA ANDA077783 Cipla USA Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 69097-149_23558714-cd2c-4bd8-961b-303c15241dde 69097-149 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20101101 ANDA ANDA077783 Cipla USA Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 69097-151_23558714-cd2c-4bd8-961b-303c15241dde 69097-151 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20101101 ANDA ANDA077783 Cipla USA Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 69097-152_23558714-cd2c-4bd8-961b-303c15241dde 69097-152 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20101101 ANDA ANDA077783 Cipla USA Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 69097-153_4051eab0-4c5d-4dde-a240-4dd0bd9675ad 69097-153 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET ORAL 20100524 ANDA ANDA077135 Cipla USA Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 69097-154_4051eab0-4c5d-4dde-a240-4dd0bd9675ad 69097-154 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET ORAL 20100524 ANDA ANDA077135 Cipla USA Inc. VALACYCLOVIR HYDROCHLORIDE 1000 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 69097-155_9e8d32ff-d62d-4801-b465-72edee82ea93 69097-155 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20070206 ANDA ANDA077162 Cipla Limited SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 69097-156_9e8d32ff-d62d-4801-b465-72edee82ea93 69097-156 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20070206 ANDA ANDA077162 Cipla Limited SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 69097-157_9e8d32ff-d62d-4801-b465-72edee82ea93 69097-157 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20070206 ANDA ANDA077162 Cipla Limited SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 69097-158_6ce1f6d1-71b3-4b95-bd2a-087d8c3f039c 69097-158 HUMAN PRESCRIPTION DRUG MELOXICAM meloxicam TABLET ORAL 20060719 ANDA ANDA077929 Cipla USA Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 69097-159_6ce1f6d1-71b3-4b95-bd2a-087d8c3f039c 69097-159 HUMAN PRESCRIPTION DRUG MELOXICAM meloxicam TABLET ORAL 20060719 ANDA ANDA077929 Cipla USA Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 69097-173_cda8a848-c7c2-4677-b68c-73490c01f708 69097-173 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20071231 ANDA ANDA077559 Cipla Limited ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 2.5; .5 mg/3mL; mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 69097-195_304fa966-ae86-48a7-8785-0b96f20e82ee 69097-195 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20071231 ANDA ANDA078262 Cipla Limited GRANISETRON HYDROCHLORIDE .1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 69097-196_81de223f-8c50-4e5e-9de8-71433b843858 69097-196 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20080630 ANDA ANDA078258 Cipla Limited GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 69097-197_81de223f-8c50-4e5e-9de8-71433b843858 69097-197 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20080630 ANDA ANDA078258 Cipla Limited GRANISETRON HYDROCHLORIDE 4 mg/4mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 69097-225_d06eb627-6dd7-4b7b-bb8d-249edb7a03f8 69097-225 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Cipla USA, Inc. DOXYCYCLINE HYCLATE 50 mg/1 69097-226_d06eb627-6dd7-4b7b-bb8d-249edb7a03f8 69097-226 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Cipla USA, Inc. DOXYCYCLINE HYCLATE 100 mg/1 69097-227_2d708b1e-0332-48e0-893b-9957ad611668 69097-227 HUMAN PRESCRIPTION DRUG doxycycline hyclate doxycycline hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 Cipla USA, Inc. DOXYCYCLINE HYCLATE 100 mg/1 69100-1001_3e2faada-17fe-47c5-8abf-f3bf18665a67 69100-1001 HUMAN OTC DRUG TMC-A Hair Tonic OATMEAL LIQUID TOPICAL 20140711 OTC MONOGRAPH FINAL part347 Gahwa Well Food Co.,Ltd OATMEAL .0001 g/100mL 69100-2001_83d30a96-9213-41d1-8131-05be7db54db5 69100-2001 HUMAN OTC DRUG TMC-A Anti Hairloss GLYCERIN SHAMPOO TOPICAL 20140711 OTC MONOGRAPH FINAL part347 Gahwa Well Food Co.,Ltd GLYCERIN 2 g/100g 69101-001_14193f04-0258-46bc-8830-ff6113a50033 69101-001 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20140929 ANDA ANDA065287 Burke Therapeutics, LLC DOXYCYCLINE HYCLATE 20 mg/1 69103-2400_294cef14-6b97-4221-9f9e-13e9529194ff 69103-2400 HUMAN OTC DRUG Biotic-Plus bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine OINTMENT TOPICAL 20140724 OTC MONOGRAPH FINAL part333B Provision Medical BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; .4; 3.5; 5000 [iU]/g; mg/g; mg/g; [iU]/g 69103-3500_ee784266-bfe1-4518-b47e-7224dc58b834 69103-3500 HUMAN OTC DRUG Burn with Aloe Lidocaine Hydrochloride SPRAY TOPICAL 20140829 OTC MONOGRAPH NOT FINAL part348 Provision Medical LIDOCAINE HYDROCHLORIDE 200 g/L 69103-3501_ed3cb7fd-75d1-4b20-ad45-39fd5763a751 69103-3501 HUMAN OTC DRUG First Aid Antiseptic benzalkonium chloride and benzocaine SPRAY TOPICAL 20140829 OTC MONOGRAPH NOT FINAL part333A Provision Medical BENZALKONIUM CHLORIDE; BENZOCAINE 1; 50 g/L; g/L 69103-3502_fc8fa480-192d-4854-9a8e-7819f561dbec 69103-3502 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SPRAY TOPICAL 20140829 OTC MONOGRAPH NOT FINAL part333A Provision Medical ISOPROPYL ALCOHOL 700 mL/L 69103-3503_e4dd0127-0322-4b4f-9b60-6c44b57e0991 69103-3503 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SPRAY TOPICAL 20140829 OTC MONOGRAPH NOT FINAL part333A Safetec of America, Inc. HYDROGEN PEROXIDE 30 mL/L 69103-3553_82d0a229-1c96-43b2-9f8c-44af83fae748 69103-3553 HUMAN OTC DRUG First Aid benzalkonium chloride and lidocaine CREAM TOPICAL 20141202 OTC MONOGRAPH NOT FINAL part333A Provision Medical BENZALKONIUM CHLORIDE; LIDOCAINE 1.3; 5 mg/g; mg/g 69103-5005_2a1ca9f4-e0b9-4540-bb99-091ad0404e17 69103-5005 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20140829 OTC MONOGRAPH FINAL part333B Provision Medical BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g 69106-010_bc78e6e2-db9a-4a2b-8da0-e996931721aa 69106-010 HUMAN OTC DRUG IT RADIANT CC IN MELTING FOUNDATION BE10 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .71; 1.68 g/13g; g/13g 69106-020_7cee0024-ea4d-4793-b789-e4331f8f664b 69106-020 HUMAN OTC DRUG IT RADIANT CC IN MELTING FOUNDATION BE15 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .71; 1.68 g/13g; g/13g 69106-030_84cab501-bf11-42c5-8766-d73c0e48c079 69106-030 HUMAN OTC DRUG IT RADIANT CC IN MELTING FOUNDATION BE20 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .71; 1.68 g/13g; g/13g 69106-040_4010e579-1c03-48ca-994d-f9318b8c33b7 69106-040 HUMAN OTC DRUG IT RADIANT CC CUSHION BE10 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 1.05; .45; 1.07 g/15g; g/15g; g/15g 69106-050_f14cbfae-e07e-4271-a30e-0b32a2e2b768 69106-050 HUMAN OTC DRUG IT RADIANT CC CUSHION BP15 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 1.05; .45; 1.07 g/15g; g/15g; g/15g 69106-060_22037846-fd28-448b-93f2-ab4deeb4ffe5 69106-060 HUMAN OTC DRUG IT RADIANT CC CUSHION BE20 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 1.05; .45; 1.07 g/15g; g/15g; g/15g 69106-070_b39ff79b-270b-44ab-b936-51d3c3ce131c 69106-070 HUMAN OTC DRUG IT RADIANT GLOW BB TRUE BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 2.9; .88 mg/30mL; mg/30mL; mg/30mL 69106-080_46fa36af-230b-4d91-82fa-228a59d56429 69106-080 HUMAN OTC DRUG IT RADIANT GLOW BB CLASSIC BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 2.9; .88 mg/30mL; mg/30mL; mg/30mL 69106-090_eb17f988-7d9e-4079-bbeb-4d19dfbf545e 69106-090 HUMAN OTC DRUG IT RADIANT MULTIPLE CC FOR MAN OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 2.1; .9; 2.09 mg/30mL; mg/30mL; mg/30mL 69106-100_90657a17-065e-4bb4-80d8-e08486132ebc 69106-100 HUMAN OTC DRUG IT RADIANT CC OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 2.01; .75; 1.27 mg/30mL; mg/30mL; mg/30mL 69106-110_6f4b362a-ac93-4660-bb55-97d75b495dc8 69106-110 HUMAN OTC DRUG IT RADIANT BRIGHTENING Dimethicone CREAM TOPICAL 20140701 OTC MONOGRAPH FINAL part347 F&CO Co., Ltd. DIMETHICONE 1 mg/50mL 69106-120_ade417ab-dcda-4ace-901d-0488699c29ff 69106-120 HUMAN OTC DRUG CLEAN IT ZERO RADIANCE Mineral Oil CREAM TOPICAL 20140701 OTC MONOGRAPH FINAL part347 F&CO Co., Ltd. MINERAL OIL 63.2 mg/100mL 69106-130_b305007d-38f2-40c5-ab51-b09c917be4b3 69106-130 HUMAN OTC DRUG PRIME PRIMER FINISH Dimethicone POWDER TOPICAL 20140701 OTC MONOGRAPH FINAL part347 F&CO Co., Ltd. DIMETHICONE 2.16 g/12g 69106-140_492e03c3-5c44-461c-b920-38f686c64d52 69106-140 HUMAN OTC DRUG PRIME PRIMER HYDRATING FINISH Dimethicone POWDER TOPICAL 20140701 OTC MONOGRAPH FINAL part347 F&CO Co., Ltd. DIMETHICONE 1.85 g/12g 69106-150_84efea03-9cfb-4795-9ca5-4280d9491130 69106-150 HUMAN OTC DRUG PRIME PRIMER HYDRATING BALM Titanium Dioxide CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE .02 g/20g 69106-160_ae7953b0-2cdd-4ebc-a296-d6f02de4abbd 69106-160 HUMAN OTC DRUG PRIME PRIMER CLASSIC Dimethicone CREAM TOPICAL 20140701 OTC MONOGRAPH FINAL part347 F&CO Co., Ltd. DIMETHICONE 1.5 mg/30mL 69106-170_ff72b1d3-31f8-4664-a490-8190cf0ba08b 69106-170 HUMAN OTC DRUG PRIME PRIMER HYDRATING Dimethicone CREAM TOPICAL 20140701 OTC MONOGRAPH FINAL part347 F&CO Co., Ltd. DIMETHICONE .9 mg/30mL 69106-180_c5529b40-6053-4e66-bb11-426358163845 69106-180 HUMAN OTC DRUG PRIME PRIMER BB SHEER Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 2.9; .88 mg/30mL; mg/30mL; mg/30mL 69106-190_e2cfd4e5-8a0f-41e5-bdfb-fa7acb2bec09 69106-190 HUMAN OTC DRUG PRIME PRIMER BB NUDE Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 2.9; .88 mg/30mL; mg/30mL; mg/30mL 69108-001_26bc01dd-3752-48a4-bb65-a04867b0d414 69108-001 HUMAN OTC DRUG smilecare SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20140601 OTC MONOGRAPH FINAL part355 Shantou MContinents Trading Co, LTD SODIUM MONOFLUOROPHOSPHATE 64 mg/8g 69109-004_fc59ad0a-e1a6-40e9-a273-07086413c616 69109-004 HUMAN OTC DRUG Simplicity Desensitizing Lidocaine GEL TOPICAL 20140715 OTC MONOGRAPH NOT FINAL part348 Simplicity Laser, LLC LIDOCAINE 40 mg/mL 69114-1001_1751bc34-4dd1-4169-a3d5-2cc522213838 69114-1001 HUMAN OTC DRUG Narasoo Healing SALICYLIC ACID SHAMPOO TOPICAL 20140716 OTC MONOGRAPH FINAL part358H RAKU STORY Co., Ltd SALICYLIC ACID .06 g/mL 69114-2001_bbdc50eb-77ac-4b8b-b0ac-a046f4487890 69114-2001 HUMAN OTC DRUG Narasoo Hair Tonic SALICYLIC ACID LIQUID TOPICAL 20140716 OTC MONOGRAPH FINAL part358H RAKU STORY Co., Ltd SALICYLIC ACID .06 g/mL 69119-001_fc134c19-d4aa-46cb-ac13-07a1e192bb08 69119-001 HUMAN OTC DRUG BANDAGE benzalkonium chloride SWAB TOPICAL 20140716 OTC MONOGRAPH NOT FINAL part333A Dongyang Haodi Medical CO.,Ltd BENZALKONIUM CHLORIDE .0012 mg/mg 69120-1000_f41fdc85-3c23-4bf6-a4ca-684a12e20b59 69120-1000 HUMAN PRESCRIPTION DRUG Relyyks Patch Menthol, Lidocaine PATCH TOPICAL 20141111 UNAPPROVED DRUG OTHER Kaylana Pharm, Inc LIDOCAINE; MENTHOL 4; 4 g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 69121-001_c2439eb0-35a1-4954-af4b-d0bdac16c768 69121-001 HUMAN OTC DRUG TopicSkin HYDRASTIS CANADENSIS WHOLE, MENTHA PIPERITA, MELISSA OFFICINALIS CREAM TOPICAL 20141110 UNAPPROVED HOMEOPATHIC ZBM Natural Medicine Ltd. HYDRASTIS CANADENSIS WHOLE; MELISSA OFFICINALIS; MENTHA PIPERITA 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 69123-111_7d1c93bb-808e-4e8d-9670-af940f07a4bc 69123-111 HUMAN OTC DRUG Skin Protectant Colloidal Oatmeal OINTMENT TOPICAL 20140725 OTC MONOGRAPH FINAL part347 ELAJ, LLC OATMEAL .57 g/57g 69124-001_d928dae1-fb21-4492-bae2-91bee00b5862 69124-001 HUMAN OTC DRUG Purse Essentials hand sanitizer Anti-Bacterial Hand Wild Passion Flower ALCOHOL GEL TOPICAL 20140716 OTC MONOGRAPH NOT FINAL part333E Kingsbridge International, Inc. ALCOHOL 650 mg/mL 69124-002_34f191cd-822e-4256-967b-ddd5e90b6a3c 69124-002 HUMAN OTC DRUG Purse Essentials hand sanitizer Anti-Bacterial Hand Vanilla Sugar ALCOHOL GEL TOPICAL 20140716 OTC MONOGRAPH NOT FINAL part333E Kingsbridge International, Inc. ALCOHOL 650 mg/mL 69124-003_42365e27-ce8a-4a2b-ab30-4226680dcf34 69124-003 HUMAN OTC DRUG Purse Essentials hand sanitizer Anti-Bacterial Hand Berry Sorbet ALCOHOL GEL TOPICAL 20140716 OTC MONOGRAPH NOT FINAL part333E Kingsbridge International, Inc. ALCOHOL 650 mg/mL 69125-001_3b4535d4-b08e-4498-8805-9f8e7b508915 69125-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140718 UNAPPROVED MEDICAL GAS SMP Home Medical OXYGEN 99 L/100L 69126-001_be04e0ca-726b-4575-af94-34f92f44c377 69126-001 HUMAN PRESCRIPTION DRUG Ammonia N 13 Ammonia N 13 INJECTION INTRAVENOUS 20141031 ANDA ANDA204465 Global Isotopes, LLC d/b/a Zevacor Molecular AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 69126-002_0a83df9e-faf4-4c0b-80d2-366efa5ccfde 69126-002 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 Sodium Fluoride F 18 INJECTION INTRAVENOUS 20141031 ANDA ANDA204464 Global Isotopes, LLC d/b/a Zevacor Molecular FLUORIDE ION F-18 10 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 69126-003_ba41f87d-23b3-410f-b9c9-346e742d40ca 69126-003 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F 18 INJECTION INTRAVENOUS 20141031 ANDA ANDA204463 Global Isotopes, LLC d/b/a Zevacor Molecular FLUDEOXYGLUCOSE F-18 20 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 69128-001_fbb1eee7-5268-43f7-9cf3-2a26af58be56 69128-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140721 UNAPPROVED MEDICAL GAS Imedequip dba Independent Medical Equipment OXYGEN 99 L/100L 69129-010_23e9fa8e-7332-47dd-9129-93298029a6e7 69129-010 HUMAN OTC DRUG Hydro Kleen AF Benzalkonium Chloride LIQUID TOPICAL 20140731 OTC MONOGRAPH NOT FINAL part333E Productive Practices BENZALKONIUM CHLORIDE .13 g/mL 69133-010_b7733180-bd35-40f2-9572-af592e7277fb 69133-010 HUMAN OTC DRUG BIOXIDEA MIRACLE 48 EXCELLENCE DIAMOND MASK Allantoin GEL TOPICAL 20140701 OTC MONOGRAPH FINAL part347 Cosmetics Institute Technology Co., Ltd. ALLANTOIN .15 g/31 69133-020_8ff80105-46ff-49d9-85fe-8a3a9cdf0c2c 69133-020 HUMAN OTC DRUG BIOXIDEA MIRACLE 48 EXCELLENCE GOLD MASK Allantoin GEL TOPICAL 20140701 OTC MONOGRAPH FINAL part347 Cosmetics Institute Technology Co., Ltd. ALLANTOIN .15 g/31 69133-030_a629289f-6bfb-4012-aaeb-cc0af33d17d4 69133-030 HUMAN OTC DRUG BIOXIDEA ELEMENT 48 NATURA DIAMOND MASK Allantoin PATCH TOPICAL 20140701 OTC MONOGRAPH FINAL part347 Cosmetics Institute Technology Co., Ltd. ALLANTOIN .15 g/31 69133-040_03897604-650a-49d6-89ab-6810deb7503a 69133-040 HUMAN OTC DRUG BIOXIDEA ELEMENT 48 NATURA GOLD MASK Allantoin PATCH TOPICAL 20140701 OTC MONOGRAPH FINAL part347 Cosmetics Institute Technology Co., Ltd. ALLANTOIN .15 g/31 69134-0001_a8afd835-93ef-4a93-a361-46d4ad790ac7 69134-0001 HUMAN OTC DRUG Lymph Drainage not applicable LIQUID ORAL 20140828 UNAPPROVED HOMEOPATHIC Carnivora Research International ACTIVATED CHARCOAL; ARANEUS DIADEMATUS; ARSENIC TRIIODIDE; BAPTISIA TINCTORIA; CAPSICUM; CARPINUS BETULUS FLOWERING TOP; CENTAURIUM ERYTHRAEA FLOWER; COPPER GLUCONATE; ECHINACEA ANGUSTIFOLIA; LACHESIS MUTA VENOM; LARIX DECIDUA FLOWERING TOP; LEMON JUICE; LOBELIA INFLATA; MANGANESE GLUCONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; POTASSIUM CHLORIDE; SCROPHULARIA NODOSA; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; ZINC GLUCONATE 8; 8; 8; 3; 6; 8; 8; 6; 2; 8; 8; 3; 3; 6; 8; 3; 3; 6; 2; 8; 12; 8; 3; 4; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 69138-783_ed539e7d-d566-44e3-b20d-879767a8f002 69138-783 HUMAN OTC DRUG Sani Claw Wipes ALCOHOL CLOTH TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part333E Homeland Industrial Supply ALCOHOL 620 mg/g 69139-001_871fa8e9-533a-471c-8f83-6d2446e56a07 69139-001 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333A YIWU HAODING MEDICAL CO.,LTD ALCOHOL 70 mL/100mL 69139-101_185e8564-274d-4813-8616-7d4cc6792bfe 69139-101 HUMAN OTC DRUG Royal ANTIBACTERIAL BANDAGE benzalkonium chloride SWAB TOPICAL 20140912 OTC MONOGRAPH NOT FINAL part333A YIWU HAODING MEDICAL CO.,LTD BENZALKONIUM CHLORIDE .12 g/100g 69139-102_fe26b5ea-3013-4bc7-a1f4-9753facf4a43 69139-102 HUMAN OTC DRUG Assured ANTIBACTERIAL BANDAGE benzalkonium chloride SWAB TOPICAL 20140912 OTC MONOGRAPH NOT FINAL part333A YIWU HAODING MEDICAL CO.,LTD BENZALKONIUM CHLORIDE .12 g/100g 69139-103_974e56b8-9728-49bd-b345-caef92077a1b 69139-103 HUMAN OTC DRUG Equate ANTIBACTERIAL BANDAGE benzalkonium chloride SWAB TOPICAL 20140912 OTC MONOGRAPH NOT FINAL part333A YIWU HAODING MEDICAL CO.,LTD BENZALKONIUM CHLORIDE .12 g/100g 69142-001_abb19068-91b0-4f21-b3d2-b3c138507876 69142-001 HUMAN OTC DRUG Breast Essence II Dimethicone, Allantoin CREAM TOPICAL 20140729 OTC MONOGRAPH FINAL part347 yeojaya ALLANTOIN; DIMETHICONE 1; .5 mg/50mL; mg/50mL 69145-201_98aac02a-f7d4-4376-ad23-0aa794f03c99 69145-201 HUMAN OTC DRUG Desert Harvest RELEVEUM LIDOCAINE CREAM TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part348 Desert Harvest Inc. LIDOCAINE 40 mg/mL 69147-196_7ae3abda-27ff-4a9f-9214-fd3c36c206f3 69147-196 HUMAN OTC DRUG FRENCH SECRET SPF - 15 Day Broad-Spectrum TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 Manupro, Inc. TITANIUM DIOXIDE; ZINC OXIDE 35; 35 mg/mL; mg/mL 69148-001_01867a4d-1d9b-4ffc-aa1d-80675a1b8219 69148-001 HUMAN OTC DRUG ARC Skin Protectant ALLANTOIN OINTMENT TOPICAL 20140806 OTC MONOGRAPH FINAL part347 Anjon Biologics, Inc ALLANTOIN .5 g/100g 69149-100_79d7196c-41c5-4bb0-be8d-c3c0cebd1e35 69149-100 HUMAN OTC DRUG PHS Hair Science Pro Hair Loss Tonic Salicylic Acid, Niacinamide, Menthol LIQUID TOPICAL 20140825 UNAPPROVED DRUG OTHER Revamp International Pte. Ltd. MENTHOL; NIACINAMIDE; SALICYLIC ACID .3; .3; .3 1/100mL; 1/100mL; 1/100mL 69149-101_a18d381b-314c-436f-8398-d9866e5c82b2 69149-101 HUMAN OTC DRUG PHS Hair Science Fem Hair Loss Tonic Salicylic Acid, Niacinamide, Menthol LIQUID TOPICAL 20140826 UNAPPROVED DRUG OTHER Revamp International Pte. Ltd. MENTHOL; NIACINAMIDE; SALICYLIC ACID .3; .3; .3 1/100mL; 1/100mL; 1/100mL 69149-102_8a2afc0e-2be6-476d-a0c6-5e394e5f3d9f 69149-102 HUMAN OTC DRUG PHS Hair Science Hom Hair Loss Tonic Salicylic Acid, Niacinamide, Menthol LIQUID TOPICAL 20140917 UNAPPROVED DRUG OTHER Revamp International Pte. Ltd. MENTHOL; NIACINAMIDE; SALICYLIC ACID .3; .3; .3 1/100mL; 1/100mL; 1/100mL 69149-103_2a417d0b-10a9-4614-bf0c-c8192155351d 69149-103 HUMAN OTC DRUG PHS Hair Science Adv Revitalizing Scalp Ampoule Eucalyptus Oil, Allantoin LIQUID TOPICAL 20140917 UNAPPROVED DRUG OTHER Revamp International Pte. Ltd. ALLANTOIN; EUCALYPTUS OIL .1; .05 1/10mL; 1/10mL 69150-400_bf68e5f3-a07d-4674-bc03-d4ba7bf42df4 69150-400 HUMAN PRESCRIPTION DRUG Ibuprofen IBUPROFEN TABLET, COATED ORAL 20090502 ANDA ANDA078329 Biomes Pharmaceuticals LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 69150-600_5f358a9c-46a2-40b3-a09b-dec0f23111df 69150-600 HUMAN PRESCRIPTION DRUG Ibuprofen IBUPROFEN TABLET, COATED ORAL 20090502 ANDA ANDA078329 Biomes Pharmaceuticals LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 69150-800_8a81f004-63e2-4cc7-b779-43a75bc26673 69150-800 HUMAN PRESCRIPTION DRUG Ibuprofen IBUPROFEN TABLET, COATED ORAL 20090502 ANDA ANDA078329 Biomes Pharmaceuticals LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 69151-100_e1b2de5a-624b-4b38-806f-697bc1e3542f 69151-100 HUMAN OTC DRUG Aspi-Rub Pain Reliever Methyl Salicylate SPRAY TOPICAL 20140829 OTC MONOGRAPH NOT FINAL part348 AspiRub Enterprises LLC METHYL SALICYLATE 23 g/100g 69152-0001_0449db5e-2b58-3333-e054-00144ff8d46c 69152-0001 HUMAN OTC DRUG Dilon 40 (Number 1) Cactus Grandiflorus, Carbo Vegetabilis PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ACTIVATED CHARCOAL; SELENICEREUS GRANDIFLORUS STEM 200; 30 [hp_C]/1; [hp_C]/1 69152-0005_0784fdc7-8d28-4f9a-e054-00144ff8d46c 69152-0005 HUMAN OTC DRUG Nonak 40 (Number 5) Ipecacuanha, Bryonia Alba PELLET ORAL 20141110 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; IPECAC 30; 200 [hp_C]/1; [hp_C]/1 69152-0006_044a84cf-ec88-5e5e-e054-00144ff8d46c 69152-0006 HUMAN OTC DRUG Cals 40 (Number 6) Antimonium Crudum, Mezereum PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ANTIMONY TRISULFIDE; DAPHNE MEZEREUM BARK 6; 200 [hp_C]/1; [hp_C]/1 69152-0007_079ab69e-698f-4b6e-e054-00144ff8d46c 69152-0007 HUMAN OTC DRUG Kalop 40 (Number 7) Pulsatilla Nigricans, Nux Vomica PELLET ORAL 20141111 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC PULSATILLA PRATENSIS; STRYCHNOS NUX-VOMICA SEED 200; 200 [hp_C]/1; [hp_C]/1 69152-0008_0449ba1f-849e-15c0-e054-00144ff88e88 69152-0008 HUMAN OTC DRUG Bejinj 40 (Number 8) Antimonium Crudum, Arnica Montana PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ANTIMONY TRISULFIDE; ARNICA MONTANA 200; 3 [hp_C]/1; [hp_C]/1 69152-0010_084413d5-d269-12d8-e054-00144ff88e88 69152-0010 HUMAN OTC DRUG Panuls 40 (Number 10) Antimonium crudum, Arnica montana PELLET ORAL 20141120 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ANTIMONY TRISULFIDE; ARNICA MONTANA 200; 200 [hp_C]/1; [hp_C]/1 69152-0011_0784fdc7-8d3d-4f9a-e054-00144ff8d46c 69152-0011 HUMAN OTC DRUG Onemet 40 (Number 11) Argentum Metallicum, Caladium Seguinum PELLET ORAL 20141110 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC DIEFFENBACHIA SEGUINE; SILVER 200; 30 [hp_C]/1; [hp_C]/1 69152-0013_06f9a4fe-016c-14e1-e054-00144ff88e88 69152-0013 HUMAN OTC DRUG Bedin 40 (Number 13) Thuja Occidentalis, Belladonna PELLET ORAL 20141103 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; THUJA OCCIDENTALIS LEAFY TWIG 3; 200 [hp_C]/1; [hp_C]/1 69152-0014_067bf5f8-83cd-49ac-e054-00144ff88e88 69152-0014 HUMAN OTC DRUG Rugin 40 (Number 14) Argentum Metallicum, Stramonium PELLET ORAL 20141028 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC DATURA STRAMONIUM; SILVER 200; 200 [hp_C]/1; [hp_C]/1 69152-0017_070bac62-2772-5f0d-e054-00144ff8d46c 69152-0017 HUMAN OTC DRUG Bulb 40 (Number 17) Calcarea Carbonica, Ledum Palustre PELLET ORAL 20141104 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC LEDUM PALUSTRE TWIG; OYSTER SHELL CALCIUM CARBONATE, CRUDE 30; 200 [hp_C]/1; [hp_C]/1 69152-0018_03fd2b10-96f2-6868-e054-00144ff88e88 69152-0018 HUMAN OTC DRUG Basaki 40 (Number 18) Conium Maculatum, Phytolacca PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CONIUM MACULATUM FLOWERING TOP; PHYTOLACCA AMERICANA ROOT 30; 30 [hp_C]/1; [hp_C]/1 69152-0022_03fd2b10-96d1-6868-e054-00144ff88e88 69152-0022 HUMAN OTC DRUG Bauri 40 (Number 22) Lycopodium, Bryonia alba PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; LYCOPODIUM CLAVATUM SPORE 30; 30 [hp_C]/1; [hp_C]/1 69152-0024_044d5d70-cdd1-44cf-e054-00144ff88e88 69152-0024 HUMAN OTC DRUG Sivil 40 (Number 24) Ignatia Amara, Nux Vomica PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED 200; 200 [hp_C]/1; [hp_C]/1 69152-0029_070b7c1b-86fa-163a-e054-00144ff88e88 69152-0029 HUMAN OTC DRUG Biracktam 40 (Number 29) Atropa Belladonna, Pulsatilla Nigricans PELLET ORAL 20141104 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; PULSATILLA PRATENSIS 200; 30 [hp_C]/1; [hp_C]/1 69152-0030_044b5b74-cc91-0f74-e054-00144ff8d46c 69152-0030 HUMAN OTC DRUG Jakritin 40 (Number 30) Anacardium, Capsicum PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CAPSICUM; SEMECARPUS ANACARDIUM JUICE 200; 200 [hp_C]/1; [hp_C]/1 69152-0031_063204c8-ab91-1ecd-e054-00144ff88e88 69152-0031 HUMAN OTC DRUG Lungin 40 (Number 31) Chelidonium Majus, Allium Cepa PELLET ORAL 20141027 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CHELIDONIUM MAJUS; ONION 6; 200 [hp_X]/1; [hp_C]/1 69152-0033_044d5d70-cdba-44cf-e054-00144ff88e88 69152-0033 HUMAN OTC DRUG Sponcer 40 (Number 33) Arnica Montana, Kalmia Latifolia PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; KALMIA LATIFOLIA LEAF 200; 200 [hp_C]/1; [hp_C]/1 69152-0034_0795a24d-4fbd-2039-e054-00144ff88e88 69152-0034 HUMAN OTC DRUG Ruman 40 (Number 34) Lycopodium clavatum, Nux Vomica PELLET ORAL 20141111 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED 200; 200 [hp_C]/1; [hp_C]/1 69152-0035_0709a5fb-acec-51f1-e054-00144ff88e88 69152-0035 HUMAN OTC DRUG Bendin 40 (Number 35) Nux Vomica, Lycopodium Clavatum PELLET ORAL 20141104 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED 30; 200 [hp_C]/1; [hp_C]/1 69152-0036_06bb9c09-4e1a-4859-e054-00144ff88e88 69152-0036 HUMAN OTC DRUG Utom 40 (Number 36) Sepia, Conium Maculatum, Thuja Occidentalis PELLET ORAL 20141031 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CONIUM MACULATUM FLOWERING TOP; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 3; 200; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 69152-0038_06ba7913-2885-1723-e054-00144ff8d46c 69152-0038 HUMAN OTC DRUG Tamcon 40 (Number 38) Belladonna, Cimicifuga Racemosa PELLET ORAL 20141031 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; BLACK COHOSH 200; 200 [hp_C]/1; [hp_C]/1 69152-0040_0849f10e-45e1-1c40-e054-00144ff8d46c 69152-0040 HUMAN OTC DRUG Pyrocom 40 (Number 40) Belladonna, Rhus toxicodendron PELLET ORAL 20141120 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF 200; 200 [hp_C]/1; [hp_C]/1 69152-0043_044af4a9-fc96-5c41-e054-00144ff88e88 69152-0043 HUMAN OTC DRUG Drosy 40 (Number 43) Gelsemium Sempervirens, Rhus Toxicodendron PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON PUBESCENS LEAF 6; 200 [hp_C]/1; [hp_C]/1 69152-0044_054f5cf3-7660-652c-e054-00144ff88e88 69152-0044 HUMAN OTC DRUG Bandblid 40 (Number 44) Arnica montana, Antimonium crudum PELLET ORAL 20141014 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ANTIMONY TRISULFIDE; ARNICA MONTANA 200; 30 [hp_C]/1; [hp_C]/1 69152-0045_07c336e9-9e8d-68a0-e054-00144ff8d46c 69152-0045 HUMAN OTC DRUG Spaskas 40 (Number 45) Calcarea Sulphurica, Atropa Belladonna PELLET ORAL 20141113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; CALCIUM SULFATE ANHYDROUS 30; 6 [hp_C]/1; [hp_C]/1 69152-0046_044af4a9-fca0-5c41-e054-00144ff88e88 69152-0046 HUMAN OTC DRUG Galan 40 (Number 46) Belladonna, Argentum Metallicum PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; SILVER 200; 30 [hp_C]/1; [hp_C]/1 69152-0047_061c423d-6f36-2e4d-e054-00144ff8d46c 69152-0047 HUMAN OTC DRUG Ghumer 40 (Number 47) Hyoscyamus Niger, Aurum Metallicum PELLET ORAL 20141023 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC GOLD; HYOSCYAMUS NIGER 30; 6 [hp_C]/1; [hp_C]/1 69152-0048_03fbe424-c973-204a-e054-00144ff88e88 69152-0048 HUMAN OTC DRUG Antina 40 (Number 48) Cimicifuga Racemosa Root, Bryonia Alba Root PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BLACK COHOSH; BRYONIA ALBA ROOT 200; 200 [hp_C]/1; [hp_C]/1 69152-0049_06ba032d-b58f-115f-e054-00144ff88e88 69152-0049 HUMAN OTC DRUG Stibin 40 (Number 49) Coffea Cruda, Sepia PELLET ORAL 20141031 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARABICA COFFEE BEAN; SEPIA OFFICINALIS JUICE 200; 200 [hp_C]/1; [hp_C]/1 69152-0050_070aa9bc-84e4-6ed7-e054-00144ff88e88 69152-0050 HUMAN OTC DRUG Baman 40 (Number 50) Chelidonium Majus, Aethusa Cynapium PELLET ORAL 20141104 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC AETHUSA CYNAPIUM; CHELIDONIUM MAJUS 30; 200 [hp_C]/1; [hp_C]/1 69152-0051_06195cfa-f81a-2298-e054-00144ff88e88 69152-0051 HUMAN OTC DRUG Disprol 40 (Number 51) Bryonia Alba, Cimicifuga Racemosa PELLET ORAL 20141023 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BLACK COHOSH; BRYONIA ALBA ROOT 200; 30 [hp_C]/1; [hp_C]/1 69152-0053_07550725-52e4-23f5-e054-00144ff8d46c 69152-0053 HUMAN OTC DRUG Lukis 40 (Number 53) Arsenicum album, Cimicifuga PELLET ORAL 20141108 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARSENIC TRIOXIDE; BLACK COHOSH 30; 200 [hp_C]/1; [hp_C]/1 69152-0054_044a84cf-ec7d-5e5e-e054-00144ff8d46c 69152-0054 HUMAN OTC DRUG Bijon 40 (Number 54) Cimicifuga Racemosa, Hypericum Perforatum PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BLACK COHOSH; HYPERICUM PERFORATUM 200; 30 [hp_C]/1; [hp_C]/1 69152-0055_044b5b74-cc9c-0f74-e054-00144ff8d46c 69152-0055 HUMAN OTC DRUG Lipen 40 (Number 55) Potassium Carbonate, Bryonia Alba PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; POTASSIUM CARBONATE 200; 30 [hp_C]/1; [hp_C]/1 69152-0057_044c8ea0-8225-3896-e054-00144ff8d46c 69152-0057 HUMAN OTC DRUG Parinum 40 (Number 57) Atropa Belladonna, Arnica Montana PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; ATROPA BELLADONNA 200; 30 [hp_C]/1; [hp_C]/1 69152-0058_07879288-8e33-35a7-e054-00144ff8d46c 69152-0058 HUMAN OTC DRUG Racktim 40 (Number 58) Nux Vomica, Podophyllum Peltatum PELLET ORAL 20141110 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC PODOPHYLLUM; STRYCHNOS NUX-VOMICA SEED 30; 200 [hp_C]/1; [hp_C]/1 69152-0059_0602f1c6-b32f-00d2-e054-00144ff88e88 69152-0059 HUMAN OTC DRUG Disfas 40 (Number 59) Phytolacca, Belladonna PELLET ORAL 20141022 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; PHYTOLACCA AMERICANA ROOT 30; 30 [hp_C]/1; [hp_C]/1 69152-0060_0666d58a-280c-06e5-e054-00144ff88e88 69152-0060 HUMAN OTC DRUG Moutal 40 (Number 60) Calcarea sulphurica, Arsenicum album PELLET ORAL 20141027 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARSENIC TRIOXIDE; CALCIUM SULFATE ANHYDROUS 30; 30 [hp_C]/1; [hp_C]/1 69152-0062_05efd4b8-5b60-1aeb-e054-00144ff88e88 69152-0062 HUMAN OTC DRUG Danton 40 (Number 62) Mezereum, Atropa belladonaa PELLET ORAL 20141021 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; DAPHNE MEZEREUM BARK 30; 6 [hp_C]/1; [hp_C]/1 69152-0063_062e78dc-1495-22e4-e054-00144ff88e88 69152-0063 HUMAN OTC DRUG Hemorin 40 (Number 63) Millefolium, Arnica Montana PELLET ORAL 20141024 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ACHILLEA MILLEFOLIUM; ARNICA MONTANA 6; 200 [hp_C]/1; [hp_C]/1 69152-0064_07c2cc3e-3d8c-0547-e054-00144ff88e88 69152-0064 HUMAN OTC DRUG Sidni 40 (Number 64) Mercurius Solubilis, Silicea PELLET ORAL 20141113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC MERCURIUS SOLUBILIS; SILICON DIOXIDE 30; 30 [hp_C]/1; [hp_C]/1 69152-0065_044c92b3-b046-3a4d-e054-00144ff8d46c 69152-0065 HUMAN OTC DRUG Panace 40 (Number 65) Capsicum, Lycopodium PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CAPSICUM; LYCOPODIUM CLAVATUM SPORE 30; 30 [hp_C]/1; [hp_C]/1 69152-0067_044d5d70-cdc6-44cf-e054-00144ff88e88 69152-0067 HUMAN OTC DRUG Sisamo 40 (Number 67) Alumina, Bryonia Alba PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ALUMINUM OXIDE; BRYONIA ALBA ROOT 200; 30 [hp_C]/1; [hp_C]/1 69152-0068_05a2d47a-7f23-36ad-e054-00144ff88e88 69152-0068 HUMAN OTC DRUG Dirin 40 (Number 68) Argentum nitricum, Pulsatilla nigricans PELLET ORAL 20141018 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC PULSATILLA PRATENSIS; SILVER NITRATE 30; 30 [hp_C]/1; [hp_C]/1 69152-0069_04eeebb7-669d-5d8f-e054-00144ff8d46c 69152-0069 HUMAN OTC DRUG Adikan 40 (Number 69) Podophyllum peltatum, Arsenicum album PELLET ORAL 20141010 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARSENIC TRIOXIDE; PODOPHYLLUM 200; 30 [hp_C]/1; [hp_C]/1 69152-0070_044c92b3-b05c-3a4d-e054-00144ff8d46c 69152-0070 HUMAN OTC DRUG Respen 40 (Number 70) Arnica Montana, Atropa Belladonna PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; ATROPA BELLADONNA 30; 30 [hp_C]/1; [hp_C]/1 69152-0072_06fb3ad3-3f97-354d-e054-00144ff8d46c 69152-0072 HUMAN OTC DRUG Amhed 40 (Number 72) Atropa Belladonna, Sepia PELLET ORAL 20141103 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; SEPIA OFFICINALIS JUICE 200; 200 [hp_C]/1; [hp_C]/1 69152-0073_04c79f3a-99de-4a24-e054-00144ff8d46c 69152-0073 HUMAN OTC DRUG Adipros 40 (number 73) Helonias chamaelirium, Mezereum PELLET ORAL 20141008 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CHAMAELIRIUM LUTEUM ROOT; DAPHNE MEZEREUM BARK 30; 200 [hp_C]/1; [hp_C]/1 69152-0075_051654e9-8327-14e6-e054-00144ff88e88 69152-0075 HUMAN OTC DRUG Badispen 40 (Number 75) Caulophyllum thalictroides, Secale cornutum PELLET ORAL 20141010 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CAULOPHYLLUM THALICTROIDES ROOT; CLAVICEPS PURPUREA SCLEROTIUM 200; 30 [hp_C]/1; [hp_C]/1 69152-0076_066e20dc-0e6a-3784-e054-00144ff8d46c 69152-0076 HUMAN OTC DRUG Sirpa 40 (Number 76) Rhus Toxicodendron, Atropa Belladonna PELLET ORAL 20141027 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF 30; 200 [hp_C]/1; [hp_C]/1 69152-0078_044af4a9-fcaf-5c41-e054-00144ff88e88 69152-0078 HUMAN OTC DRUG Haran 40 (Number 78) Arnica Montana, Ledum PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; LEDUM PALUSTRE TWIG 30; 30 [hp_C]/1; [hp_C]/1 69152-0079_06a389b3-d9cd-5a0d-e054-00144ff8d46c 69152-0079 HUMAN OTC DRUG Birin 40 (Number 79) Bismuthum, Arsenicum album PELLET ORAL 20141030 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARSENIC TRIOXIDE; BISMUTH SUBNITRATE 200; 200 [hp_C]/1; [hp_C]/1 69152-0080_06bae61d-037d-3189-e054-00144ff88e88 69152-0080 HUMAN OTC DRUG Trilif 40 (Number 80) Antimonium Crudum, Graphites PELLET ORAL 20141031 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ANTIMONY TRISULFIDE; GRAPHITE 30; 30 [hp_C]/1; [hp_C]/1 69152-0086_07873e50-4edc-2252-e054-00144ff88e88 69152-0086 HUMAN OTC DRUG Onepis 40 (Number 86) Bryonia Alba, Apis Mellifica PELLET ORAL 20141110 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC APIS MELLIFERA; BRYONIA ALBA ROOT 6; 200 [hp_C]/1; [hp_C]/1 69152-0089_07bfe1bf-8de6-5b33-e054-00144ff8d46c 69152-0089 HUMAN OTC DRUG Stoul 40 (Number 89) Iris Versicolor, Arsenicum Album PELLET ORAL 20141113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARSENIC TRIOXIDE; IRIS VERSICOLOR ROOT 3; 30 [hp_C]/1; [hp_C]/1 69152-0090_070c6f25-4e72-3466-e054-00144ff88e88 69152-0090 HUMAN OTC DRUG Hardmet Car 40 (Number 90) Argentum Nitricum, Aurum Metallicum PELLET ORAL 20141104 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC GOLD; SILVER NITRATE 30; 30 [hp_C]/1; [hp_C]/1 69152-0092_062a3310-9e58-04e8-e054-00144ff88e88 69152-0092 HUMAN OTC DRUG Gallkid 40 (Number 92) Sarsaparilla, Tabacum PELLET ORAL 20141024 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SMILAX REGELII ROOT; TOBACCO LEAF 200; 30 [hp_C]/1; [hp_C]/1 69152-0093_067f9f73-8626-5fc5-e054-00144ff88e88 69152-0093 HUMAN OTC DRUG Poisthum 40 (Number 93) Ipecacuanha, Bismuthum Subnitricum PELLET ORAL 20141029 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BISMUTH SUBNITRATE; IPECAC 6; 200 [hp_C]/1; [hp_C]/1 69152-0104_07c20fac-0e3a-39e8-e054-00144ff8d46c 69152-0104 HUMAN OTC DRUG Sloth 40 (Number 104) Argentum Metallicum, Rhus Toxicodendron PELLET ORAL 20141113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SILVER NITRATE; TOXICODENDRON PUBESCENS LEAF 200; 200 [hp_C]/1; [hp_C]/1 69152-0105_07c0fb5c-187d-70da-e054-00144ff8d46c 69152-0105 HUMAN OTC DRUG Softcarb 40 (Number 105) Antimonium Crudum, Arsenicum Album PELLET ORAL 20141113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE 30; 30 [hp_C]/1; [hp_C]/1 69152-0107_070c6f25-4e8b-3466-e054-00144ff88e88 69152-0107 HUMAN OTC DRUG Inkar 40 (Number 107) Blatta Orientalis, Ipecacuanha PELLET ORAL 20141104 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BLATTA ORIENTALIS; IPECAC 30; 200 [hp_C]/1; [hp_C]/1 69152-0110_03fbe424-c97f-204a-e054-00144ff88e88 69152-0110 HUMAN OTC DRUG Alpan 40 (Number 110) Nux Vomica 200C HPUS, Bryonia Alba Root 30C PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; STRYCHNOS NUX-VOMICA SEED 30; 200 [hp_C]/1; [hp_C]/1 69152-0111_067c5c20-3b01-68ab-e054-00144ff88e88 69152-0111 HUMAN OTC DRUG Ginos 40 (Number 111) Conium Maculatum, Ignatia Amara PELLET ORAL 20141028 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CONIUM MACULATUM FLOWERING TOP; STRYCHNOS IGNATII SEED 30; 30 [hp_C]/1; [hp_C]/1 69152-0113_09763398-b7ac-0532-e054-00144ff8d46c 69152-0113 HUMAN OTC DRUG Drich 40 (Number 113) Antimonium crudum, Hepar sulphuris calcareum PELLET ORAL 20141205 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ANTIMONY TRISULFIDE; CALCIUM SULFIDE 30; 200 [hp_C]/1; [hp_C]/1 69152-0114_0551a58c-fc95-3c75-e054-00144ff88e88 69152-0114 HUMAN OTC DRUG Comsal 40 (Number 114) Platinum metallicum, Medorrhinum PELLET ORAL 20141014 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC GONORRHEAL URETHRAL SECRETION HUMAN; PLATINUM 30; 30 [hp_C]/1; [hp_C]/1 69152-0119_0691e4e0-571d-6fc1-e054-00144ff88e88 69152-0119 HUMAN OTC DRUG Glowin 40 (Number 119) Secale Cornutum, Phosphorus PELLET ORAL 20141029 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CLAVICEPS PURPUREA SCLEROTIUM; PHOSPHORUS 30; 6 [hp_C]/1; [hp_C]/1 69152-0120_0691705e-371f-73d3-e054-00144ff8d46c 69152-0120 HUMAN OTC DRUG Npto 40 (Number 120) Arnica Montana, Graphites PELLET ORAL 20141029 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; GRAPHITE 30; 30 [hp_C]/1; [hp_C]/1 69152-0123_07c40915-2f3f-3093-e054-00144ff88e88 69152-0123 HUMAN OTC DRUG Sadaton 40 (Number 123) Bryonia Alba, Belladonna PELLET ORAL 20141113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; BRYONIA ALBA ROOT 200; 30 [hp_C]/1; [hp_C]/1 69152-0125_04eb9a32-8ecb-06bc-e054-00144ff88e88 69152-0125 HUMAN OTC DRUG Adinos 40 (Number 125) Lycopodium Clavatum, Ipecacuanha PELLET ORAL 20141009 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC IPECAC; LYCOPODIUM CLAVATUM SPORE 200; 200 [hp_C]/1; [hp_C]/1 69152-0128_079bede5-f5fe-03ed-e054-00144ff8d46c 69152-0128 HUMAN OTC DRUG Penpil 40 (Number 128) Sulphur, Atropa Belladonna PELLET ORAL 20141111 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; SULFUR 200; 30 [hp_C]/1; [hp_C]/1 69152-0136_0514156a-417f-694d-e054-00144ff88e88 69152-0136 HUMAN OTC DRUG Bishala 40 (Number 136) Hypericum perforatum, Arnica montana PELLET ORAL 20141010 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; HYPERICUM PERFORATUM 30; 30 [hp_C]/1; [hp_C]/1 69152-0139_06908d5d-03b8-3a05-e054-00144ff8d46c 69152-0139 HUMAN OTC DRUG Makros 40 (Number 139) Chamomilla, Arsenicum album PELLET ORAL 20141029 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARSENIC TRIOXIDE; MATRICARIA RECUTITA 200; 200 [hp_C]/1; [hp_C]/1 69152-0143_061acc74-eb53-6887-e054-00144ff8d46c 69152-0143 HUMAN OTC DRUG Fludblid 40 (Number 143) Cimicifuga Racemosa, Bovista PELLET ORAL 20141023 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BLACK COHOSH; LYCOPERDON UTRIFORME FRUITING BODY 200; 30 [hp_C]/1; [hp_C]/1 69152-0501_0693e472-47bc-559f-e054-00144ff8d46c 69152-0501 HUMAN OTC DRUG Bacnos 40 (Number 501) Mezereum, Graphites PELLET ORAL 20141029 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC DAPHNE MEZEREUM BARK; GRAPHITE 200; 30 [hp_C]/1; [hp_C]/1 69152-0506_0798e401-824d-2fce-e054-00144ff8d46c 69152-0506 HUMAN OTC DRUG Rattle 40 (Number 506) Bryonia Alba, Ipecacuanha PELLET ORAL 20141111 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; IPECAC 200; 200 [hp_C]/1; [hp_C]/1 69152-0507_0679f8de-a466-1c14-e054-00144ff88e88 69152-0507 HUMAN OTC DRUG Trigon 40 (Number 507) Belladonna, Ignatia amara PELLET ORAL 20141028 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; STRYCHNOS IGNATII SEED 200; 30 [hp_C]/1; [hp_C]/1 69152-0508_06a4d145-6305-1b60-e054-00144ff8d46c 69152-0508 HUMAN OTC DRUG Bitu 40 (Number 508) Antimonium crudum, Ruta graveolens PELLET ORAL 20141030 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ANTIMONY TRISULFIDE; RUTA GRAVEOLENS FLOWERING TOP 30; 6 [hp_C]/1; [hp_C]/1 69152-0510_05a2d47a-7f12-36ad-e054-00144ff88e88 69152-0510 HUMAN OTC DRUG Conpil 40 (Number 510) Conium maculatum, Nux vomica PELLET ORAL 20141018 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CONIUM MACULATUM FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED 30; 200 [hp_C]/1; [hp_C]/1 69152-0519_071c6e97-324b-026d-e054-00144ff8d46c 69152-0519 HUMAN OTC DRUG Klothem (Number 519) Pulsatilla nigricans, Belladonna PELLET ORAL 20141106 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; PULSATILLA PRATENSIS 200; 30 [hp_C]/1; [hp_C]/1 69152-0520_066cb017-12c0-03ec-e054-00144ff8d46c 69152-0520 HUMAN OTC DRUG Phitinum 40 (Number 520) Atropa Belladonna, Sanguinaria PELLET ORAL 20141027 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; SANGUINARIA CANADENSIS ROOT 200; 30 [hp_C]/1; [hp_C]/1 69152-0524_067dc60b-155b-27b6-e054-00144ff88e88 69152-0524 HUMAN OTC DRUG Alartem 40 (Number 524) Artemisia Vulgaris, Cuprum Metallicum PELLET ORAL 20141028 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARTEMISIA VULGARIS ROOT; COPPER 6; 200 [hp_C]/1; [hp_C]/1 69152-0527_067d9633-bdb2-3df0-e054-00144ff8d46c 69152-0527 HUMAN OTC DRUG Ames 40 (Number 527) Veratrum Album, Mercurius Solubilis PELLET ORAL 20141028 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC MERCURIUS SOLUBILIS; VERATRUM ALBUM ROOT 6; 30 [hp_C]/1; [hp_C]/1 69152-0528_03fd2b10-96c4-6868-e054-00144ff88e88 69152-0528 HUMAN OTC DRUG Anchin 40 (Number 528) ACONITUM NAPELLUS,CONIUM MACULATUM PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences ACONITUM NAPELLUS; CONIUM MACULATUM FLOWERING TOP 30; 200 [hp_C]/1; [hp_C]/1 69152-0532_0514156a-4167-694d-e054-00144ff88e88 69152-0532 HUMAN OTC DRUG Batinha 40 (Number 532) Hypericum peltatum, Arsenicum album PELLET ORAL 20141010 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF 30; 6 [hp_C]/1; [hp_C]/1 69152-0536_085cdf30-fd37-62e5-e054-00144ff88e88 69152-0536 HUMAN OTC DRUG Blith 40 (Number 536) Lithium carbonicum, Rhus toxicodendron PELLET ORAL 20141121 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC LITHIUM CARBONATE; TOXICODENDRON PUBESCENS LEAF 6; 200 [hp_C]/1; [hp_C]/1 69152-0537_06a193cb-3644-26db-e054-00144ff8d46c 69152-0537 HUMAN OTC DRUG Bontu 40 (Number 537) Arnica montana, Calcarea phosphorica PELLET ORAL 20141030 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; TRIBASIC CALCIUM PHOSPHATE 30; 30 [hp_C]/1; [hp_C]/1 69152-0539_06901397-6e05-251f-e054-00144ff88e88 69152-0539 HUMAN OTC DRUG Buchap 40 (Number 539) Bryonia alba, Arnica montana PELLET ORAL 20141029 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; BRYONIA ALBA ROOT 200; 200 [hp_C]/1; [hp_C]/1 69152-0544_059ee5b8-ad0a-58d5-e054-00144ff8d46c 69152-0544 HUMAN OTC DRUG Chinibes 40 (Number 544) Lycopodium clavatum, Chelidonium majus PELLET ORAL 20141018 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE 200; 30 [hp_C]/1; [hp_C]/1 69152-0546_05906f8e-ed76-0145-e054-00144ff88e88 69152-0546 HUMAN OTC DRUG Chulin 40 (Number 546) Graphites, Lycopodium Clavatum PELLET ORAL 20141017 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC GRAPHITE; LYCOPODIUM CLAVATUM SPORE 30; 30 [hp_C]/1; [hp_C]/1 69152-0548_061a1d52-51aa-41f2-e054-00144ff8d46c 69152-0548 HUMAN OTC DRUG Cytopan 40 (Number 548) Arnica Montana, Rhus Toxicodendron PELLET ORAL 20141023 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF 30; 200 [hp_C]/1; [hp_C]/1 69152-0552_05ecda10-bf96-57ab-e054-00144ff8d46c 69152-0552 HUMAN OTC DRUG Dorspi 40 (Number 552) Rhus toxicodendron, Bryonia alba PELLET ORAL 20141021 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; TOXICODENDRON PUBESCENS LEAF 30; 200 [hp_C]/1; [hp_C]/1 69152-0553_061acc74-eb40-6887-e054-00144ff8d46c 69152-0553 HUMAN OTC DRUG Eutopa 40 (Number 553 Sepia, Aurum Metallicum PELLET ORAL 20141023 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC GOLD; SEPIA OFFICINALIS JUICE 30; 6 [hp_C]/1; [hp_C]/1 69152-0556_061d3abf-6af6-2043-e054-00144ff88e88 69152-0556 HUMAN OTC DRUG Gallchi 40 (Number 556) Nux Vomica, Cinchona Officinalis PELLET ORAL 20141023 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CINCHONA OFFICINALIS BARK; STRYCHNOS NUX-VOMICA SEED 6; 200 [hp_C]/1; [hp_C]/1 69152-0568_08365334-ee83-2c42-e054-00144ff88e88 69152-0568 HUMAN OTC DRUG Indigit 40 (Number 568) Arnica montana, Aconitum napellus PELLET ORAL 20141119 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ACONITUM NAPELLUS; ARNICA MONTANA 30; 30 [hp_C]/1; [hp_C]/1 69152-0570_063044c7-c018-3919-e054-00144ff88e88 69152-0570 HUMAN OTC DRUG Jalpet 40 (Number 570) Capsicum Annuum, Arsenicum Album PELLET ORAL 20141024 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARSENIC TRIOXIDE; CAPSICUM 200; 200 [hp_C]/1; [hp_C]/1 69152-0571_0679f8de-a469-1c14-e054-00144ff88e88 69152-0571 HUMAN OTC DRUG Jarin 40 (Number 571) Belladonna, Bryonia alba PELLET ORAL 20141028 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; BRYONIA ALBA ROOT 30; 30 [hp_C]/1; [hp_C]/1 69152-0598_066b9a20-d515-43c3-e054-00144ff8d46c 69152-0598 HUMAN OTC DRUG Pitamarin 40 (Number 598) Lycopodium Clavatum, Berberis Vulgaris PELLET ORAL 20141027 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BERBERIS VULGARIS ROOT BARK; LYCOPODIUM CLAVATUM SPORE 30; 30 [hp_C]/1; [hp_C]/1 69152-0603_06908d5d-03b6-3a05-e054-00144ff8d46c 69152-0603 HUMAN OTC DRUG Sar 40 (Number 603) Bryonia Alba, Lycopodium Clavatum PELLET ORAL 20141029 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; LYCOPODIUM CLAVATUM SPORE 30; 30 [hp_C]/1; [hp_C]/1 69152-0606_07c18f4e-8e22-53f9-e054-00144ff88e88 69152-0606 HUMAN OTC DRUG Sodanum 40 (Number 606) Cantharis, Rhus Toxicodendron PELLET ORAL 20141113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC LYTTA VESICATORIA; TOXICODENDRON PUBESCENS LEAF 30; 200 [hp_C]/1; [hp_C]/1 69152-0614_0680c1b9-449c-142d-e054-00144ff88e88 69152-0614 HUMAN OTC DRUG Ameno 40 (Number 614) Sepia, Bryonia Alba PELLET ORAL 20141028 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; SEPIA OFFICINALIS JUICE 30; 200 [hp_C]/1; [hp_C]/1 69152-0615_063122d3-497d-023d-e054-00144ff8d46c 69152-0615 HUMAN OTC DRUG Kanmet 40 (Number 615) Chamomilla, Belladonna PELLET ORAL 20141024 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; MATRICARIA RECUTITA 30; 200 [hp_C]/1; [hp_C]/1 69152-1008_06a73426-7112-5d7e-e054-00144ff88e88 69152-1008 HUMAN OTC DRUG Arnica Montana 3C Arnica Montana PELLET ORAL 20141030 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA 3 [hp_C]/1 69153-010_d5b7b377-f5af-4609-8b08-63c87839946d 69153-010 HUMAN OTC DRUG HERBAL DAHUIN BEAUTY OATMEAL SOAP TOPICAL 20140801 OTC MONOGRAPH FINAL part347 AN Co Ltd. OATMEAL .007 g/31 69153-020_14071c01-e34f-403a-9507-03617782ad7a 69153-020 HUMAN OTC DRUG AN ADC FACE UP SPECIAL PROGRAM OATMEAL SOLUTION TOPICAL 20140801 OTC MONOGRAPH FINAL part347 AN Co Ltd. OATMEAL .00007 mg/101 69153-030_8dbe6c83-21fc-4d2a-87fa-0c0515bf859b 69153-030 HUMAN OTC DRUG AN ADC EGF WRINKLE EYE Glycerin CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 AN Co Ltd. GLYCERIN 5 g/25g 69153-040_5177928d-3c59-4b3d-b93a-66af8347b5f5 69153-040 HUMAN OTC DRUG AN ADC WHITENING ESSENCE OATMEAL CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 AN Co Ltd. OATMEAL .003 g/55g 69153-050_55f3cbd5-f186-44da-b9c1-fdd7e1cec6a2 69153-050 HUMAN OTC DRUG AN ADC WRINKLE Dimethicone CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 AN Co Ltd. DIMETHICONE .65 g/50g 69153-060_cd5c1ea8-b21c-4438-8056-fa8147417a35 69153-060 HUMAN OTC DRUG AN ADC WHITENING BB Titanium Dioxide CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 AN Co Ltd. TITANIUM DIOXIDE 2.6 g/50g 69154-010_e8ad9ea3-a238-48f5-be2a-5e3629f721d3 69154-010 HUMAN OTC DRUG THE YEON CMK PORE BLEMISH BC 01 PINK BEIGE TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 The Yeon Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .9; 2.11 g/12g; g/12g 69154-020_d58fae40-f56b-4eb9-8a4c-0d4059624d1a 69154-020 HUMAN OTC DRUG THE YEON CMK PORE BLEMISH BC 02 NATURAL BEIGE TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 The Yeon Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE .9; 2.11 g/12g; g/12g 69154-030_5fc99c8d-b6e8-47c6-9ed5-8660506073df 69154-030 HUMAN OTC DRUG THE YEON LOTUS FLOWER BC CUSHION PACT 01 LIGHT BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 The Yeon Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1; 1.4; .001 g/14g; g/14g; g/14g 69154-040_9da2a2d7-847d-4e1b-a9fb-38b8052bf078 69154-040 HUMAN OTC DRUG THE YEON LOTUS FLOWER BC CUSHION PACT 02 NATURAL BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 The Yeon Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1; 1.4; .001 g/14g; g/14g; g/14g 69154-050_53f8451d-6f40-44f0-bb85-9d03e7e3c326 69154-050 HUMAN OTC DRUG THE YEON STYLE Y LONG WEAR PERFECT FIT BB 21 LIGHT BEIGE TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 The Yeon Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE 1.05; 3.75 mg/30mL; mg/30mL 69154-060_524e6df1-0f7f-4151-a953-d4a94adf1c78 69154-060 HUMAN OTC DRUG THE YEON STYLE Y LONG WEAR PERFECT FIT BB 23 NATURAL BEIGE TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 The Yeon Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE 1.05; 3.75 mg/30mL; mg/30mL 69154-070_c00c16f3-a2e7-4624-9caf-209a0a7a3072 69154-070 HUMAN OTC DRUG THE YEON STYLE Y Y GLAM LUMINOUS CC TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 The Yeon Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.84; 1.74 mg/30mL; mg/30mL 69154-080_5b8018c6-b520-4146-a9de-693a9af776ab 69154-080 HUMAN OTC DRUG THE YEON STYLE Y Y GLAM WATER BOMB CC TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 The Yeon Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.75; 1.05 mg/30mL; mg/30mL 69158-000_3171e373-6375-4467-b3f0-872e9221a773 69158-000 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 GLENVIEW PHARMA INC. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] 69158-001_3171e373-6375-4467-b3f0-872e9221a773 69158-001 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 GLENVIEW PHARMA INC. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] 69158-002_3171e373-6375-4467-b3f0-872e9221a773 69158-002 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 GLENVIEW PHARMA INC. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] 69158-003_baeb6724-4be7-43cb-9271-a4ceb28bcefb 69158-003 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 19970328 ANDA ANDA074532 GLENVIEW PHARMA INC. CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 69158-004_baeb6724-4be7-43cb-9271-a4ceb28bcefb 69158-004 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 19970328 ANDA ANDA074532 GLENVIEW PHARMA INC. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 69158-005_baeb6724-4be7-43cb-9271-a4ceb28bcefb 69158-005 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 19970328 ANDA ANDA074532 GLENVIEW PHARMA INC. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 69161-001_602a701a-b450-4bf7-b9ab-a63d9faff161 69161-001 HUMAN OTC DRUG No Pain More Gain Menthol CREAM TOPICAL 20140829 OTC MONOGRAPH NOT FINAL part348 Lugus Group LLC MENTHOL 10 mg/100mg 69161-002_b276dcef-f5c9-4560-888d-fda79fb16193 69161-002 HUMAN OTC DRUG No Pain More Gain Menthol AEROSOL, FOAM TOPICAL 20140829 OTC MONOGRAPH NOT FINAL part348 Lugus Group LLC MENTHOL 5 mg/100mg 69163-4131_8b24a2cb-c95f-411c-aeb7-6305b85e6ee7 69163-4131 HUMAN OTC DRUG ZymaDerm Iodine, Thuja Occidentalis Whole and Echinacea, Unspecified LIQUID TOPICAL 20130422 UNAPPROVED HOMEOPATHIC Naturopathix, Inc. ECHINACEA, UNSPECIFIED; IODINE; THUJA OCCIDENTALIS WHOLE 5; 5; 5 [hp_C]/13mL; [hp_X]/13mL; [hp_C]/13mL 69163-4132_4a30769a-2610-4f56-b868-82f1d28e6916 69163-4132 HUMAN OTC DRUG ZymaDerm for Cold Sores Iodine, Cinnamomum Camphora Whole, Melissa Officinalis, Beta Vulgaris, Basil and Mentha Piperita LIQUID TOPICAL 20050615 UNAPPROVED HOMEOPATHIC Naturopathix, Inc. BASIL; BETA VULGARIS; CINNAMOMUM CAMPHORA WHOLE; IODINE; MELISSA OFFICINALIS; MENTHA PIPERITA 5; 4; 5; 5; 3; 3 [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL 69163-4134_b39fa36e-b4d3-418e-9980-59746b711a67 69163-4134 HUMAN OTC DRUG ZymaDerm for Warts Iodine, Thuja Occidentalis Whole, Origanum Vulgare Subsp. Hirtum Whole, Myrtus Communis Whole, Cymbopogon Citratus Whole, and Pelargonium Graveolens Whole LIQUID TOPICAL 20050615 UNAPPROVED HOMEOPATHIC Naturopathix, Inc. CYMBOPOGON CITRATUS WHOLE; IODINE; MYRTUS COMMUNIS WHOLE; ORIGANUM VULGARE SUBSP. HIRTUM WHOLE; PELARGONIUM GRAVEOLENS WHOLE; THUJA OCCIDENTALIS WHOLE 5; 5; 3; 3; 5; 3 [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL 69163-4135_fbfce570-c344-41a8-aa8a-70e0ee592435 69163-4135 HUMAN OTC DRUG ZymaDerm for Shingles Iodine, Pelargonium Graveolens Whole, Melissa Officinalis, Beta Vulgaris, Cymbopogon Citratus Whole and Mentha Piperita LIQUID TOPICAL 20050615 UNAPPROVED HOMEOPATHIC Naturopathix, Inc. BETA VULGARIS; CYMBOPOGON CITRATUS WHOLE; IODINE; MELISSA OFFICINALIS; MENTHA PIPERITA; PELARGONIUM GRAVEOLENS WHOLE 4; 5; 5; 3; 3; 5 [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL 69164-1001_01030021-757c-446f-9833-564372485118 69164-1001 HUMAN OTC DRUG Colloidal Iodine GLYCERIN CREAM TOPICAL 20140827 OTC MONOGRAPH FINAL part347 JCI INSTITUTE OF MEDICAL SCIENCE GLYCERIN 1 g/100mL 69164-2001_99764a2f-83fc-4b5b-b71c-d606fda2b9fe 69164-2001 HUMAN OTC DRUG Colloidal Iodine IODINE SOLUTION TOPICAL 20140827 OTC MONOGRAPH NOT FINAL part333A JCI INSTITUTE OF MEDICAL SCIENCE IODINE 2 g/100mL 69164-3001_b033986f-34ca-4918-91e3-2e928eea028b 69164-3001 HUMAN OTC DRUG Colloidal Iodine Ophthalmic IODINE SOLUTION TOPICAL 20140827 OTC MONOGRAPH NOT FINAL part333A JCI INSTITUTE OF MEDICAL SCIENCE IODINE .1 g/100mL 69165-101_95beb730-ec50-4fea-bd4b-146437b7092e 69165-101 HUMAN OTC DRUG PAIN CHLORPHENIRAMINE MALEATE, METHYL SALICYLATE, SCOPOLIA CARNIOLICA WHOLE, MENTHOL, PEPPERMINT, CAMPHOR (SYNTHETIC), PHELLODENDRON AMURENSE WHOLE PATCH TOPICAL 20140812 UNAPPROVED HOMEOPATHIC GEORGE L. RODRIGUEZ M.D., PC CAMPHOR (SYNTHETIC); CHLORPHENIRAMINE MALEATE; MENTHOL; METHYL SALICYLATE; PEPPERMINT OIL; PHELLODENDRON AMURENSE WHOLE; SCOPOLIA CARNIOLICA WHOLE 13.4; 13.4; 26.9; 26.9; 26.9; 13.4; 2.7 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 69165-201_f50769ca-2c0d-422d-91ea-1c37b5a64b4c 69165-201 HUMAN OTC DRUG ANTIPAIN-S RADIX CLEMATIDIS, SEMEN MOMORDICAE, MYRRHA, OLIBANUM, MENTHOL, METHYL SALICYLATE OINTMENT TOPICAL 20140812 UNAPPROVED HOMEOPATHIC GEORGE L. RODRIGUEZ M.D., PC CLEMATIS HEXAPETALA WHOLE; FRANKINCENSE OIL; MENTHOL; MOMORDICA CHARANTIA WHOLE; MYRRH 30; 20; 50; 15; 20 mg/g; mg/g; mg/g; mg/g; mg/g 69168-029_b431a1a3-39c4-4d6c-afdc-c8b017ad89da 69168-029 HUMAN OTC DRUG Tension Headache Relief Tension Headache Relief CAPSULE ORAL 20141126 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN; CAFFEINE 500; 65 ug/1; mg/1 69168-046_015ca07a-f6b5-4741-a7b0-821cf6d4e418 69168-046 HUMAN OTC DRUG Bismuth Bismuth subsalicylate TABLET ORAL 20141223 OTC MONOGRAPH FINAL part335 Allegiant Health BISMUTH SUBSALICYLATE 262 mg/1 69168-048_c2823bad-540f-4662-8dcc-58e9f0d94efb 69168-048 HUMAN OTC DRUG Allergy Diphenhydramine HCl TABLET ORAL 20141215 OTC MONOGRAPH FINAL part341 Allegiant Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 69168-219_551d6135-2650-4c27-a20d-d56a9aba7b71 69168-219 HUMAN OTC DRUG Calcium Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20141216 OTC MONOGRAPH FINAL part331 Allegiant Health CALCIUM CARBONATE 500 mg/1 69168-226_b5d0bdf6-d934-4d79-bc66-5c25c1bfe99c 69168-226 HUMAN OTC DRUG Laxative Bisacodyl TABLET ORAL 20141223 OTC MONOGRAPH NOT FINAL part334 Allegiant Health BISACODYL 5 mg/1 69168-229_51dd53e8-22ff-4967-9124-f15c3986e4dd 69168-229 HUMAN OTC DRUG Calcium Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20141216 OTC MONOGRAPH FINAL part331 Allegiant Health CALCIUM CARBONATE 750 mg/1 69168-235_de064623-31ad-4d37-8025-922d39624f27 69168-235 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen 500 mg TABLET ORAL 20141217 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN 500 mg/1 69168-243_b4b5341d-c1b2-4cbd-9c86-bee80283fc7a 69168-243 HUMAN OTC DRUG Anti Gas Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20141216 OTC MONOGRAPH FINAL part332 Allegiant Health DIMETHICONE 125 mg/1 69168-261_a1a8c1b0-1c3d-4d32-b505-e92a19623f65 69168-261 HUMAN OTC DRUG Acetaminophen Phenylephrine HCl Acetaminophen 500mg Phenylephrine HCl 5mg TABLET ORAL 20141201 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 69168-267_91ba1618-1b2e-4281-a5e1-ba7acbae8346 69168-267 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen 500 mg and Diphenhydramine HCl 25 mg TABLET ORAL 20141223 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 69168-270_b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f 69168-270 HUMAN OTC DRUG Sinus Headache PE Maximum Strength Non-Drowsy Acetaminophen and Phenylephrine HCl TABLET ORAL 20141222 OTC MONOGRAPH FINAL part341 Allegiant Health ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 69168-272_7aef00df-816a-4ea2-a2ad-beed66dd2fe4 69168-272 HUMAN OTC DRUG Nasal Decongestant PE Maximum Strength Non-Drowsy Phenylephrine 10 mg TABLET ORAL 20141223 OTC MONOGRAPH FINAL part341 Allegiant Health PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 69168-277_4305ad50-d2a5-4d3e-9d92-cbf26e856a16 69168-277 HUMAN OTC DRUG Allergy Chlorpheniramine maleate TABLET ORAL 20141215 OTC MONOGRAPH FINAL part341 Allegiant Health CHLORPHENIRAMINE MALEATE 4 mg/1 69168-288_92b8637b-03a9-461f-b2f6-6eddaa214953 69168-288 HUMAN OTC DRUG Aspirin Chewable Aspirin 81 mg TABLET ORAL 20141218 OTC MONOGRAPH FINAL part343 Allegiant Health ASPIRIN 81 mg/1 69168-302_439b0113-2b2b-4369-b019-1437e5720f7c 69168-302 HUMAN OTC DRUG Cold and Allergy Phenylephrine HCl and Chlorpheniramine maleate TABLET ORAL 20141223 OTC MONOGRAPH FINAL part341 Allegiant Health CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 69168-309_0991388a-2eb8-4913-9efc-adf411eddf3a 69168-309 HUMAN OTC DRUG Allergy Relief Loratadine TABLET ORAL 20141216 ANDA ANDA076471 Allegiant Health LORATADINE 10 mg/1 69168-310_c0b578fb-8313-4478-b16a-d19f8ec20453 69168-310 HUMAN OTC DRUG Allergy Relief Cetirizine HCl 10 mg TABLET ORAL 20141216 ANDA ANDA078317 Allegiant Health CETIRIZINE HYDROCHLORIDE 10 mg/1 69168-312_88b54062-8b3d-4024-a957-62b3255184b9 69168-312 HUMAN OTC DRUG Aspirin Aspirin 325 mg TABLET ORAL 20141218 OTC MONOGRAPH FINAL part343 Allegiant Health ASPIRIN 325 mg/1 69168-314_418d81eb-933b-4457-ac20-603cc985d0f2 69168-314 HUMAN OTC DRUG Stool Softener Docusate Sodium 100 mg CAPSULE ORAL 20141223 OTC MONOGRAPH NOT FINAL part334 Allegiant Health DOCUSATE SODIUM 100 mg/1 69168-318_3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe5 69168-318 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin 81 mg TABLET ORAL 20141218 OTC MONOGRAPH FINAL part343 Allegiant Health ASPIRIN 81 mg/1 69168-319_3f020cf2-6011-4216-9b39-0b3dc5f0749c 69168-319 HUMAN OTC DRUG Cold Multi-Symptom Night-time Acetaminophen,Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCI TABLET ORAL 20141223 OTC MONOGRAPH FINAL part341 Allegiant Health ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 69168-323_38bedaf5-44be-4695-9c21-ef40a0a0c960 69168-323 HUMAN OTC DRUG Cold Multi-Symptom Day-time Acetaminophen,Guaifenesin, Dextromethorphan HBr and Phenylephrine HCI TABLET ORAL 20141223 OTC MONOGRAPH FINAL part341 Allegiant Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 69168-328_8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7 69168-328 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen 500 mg TABLET ORAL 20141217 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN 500 mg/1 69168-330_9f384bbe-077d-47da-866d-9b29d1bbe8d9 69168-330 HUMAN OTC DRUG Mucus Relief Immediate Release Guaifenesin TABLET ORAL 20141223 OTC MONOGRAPH FINAL part341 Allegiant Health GUAIFENESIN 400 mg/1 69168-331_0d735b0d-9e20-45e1-8186-476dd24a53b7 69168-331 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin 325 mg TABLET ORAL 20141218 OTC MONOGRAPH FINAL part343 Allegiant Health ASPIRIN 325 mg/1 69168-335_dd63b011-0573-4374-9669-8d29146e5fc9 69168-335 HUMAN OTC DRUG Ibuprofen Fast relief medicine for pain Ibuprofen 200 mg TABLET ORAL 20141219 ANDA ANDA079129 Allegiant Health IBUPROFEN 200 mg/1 69168-338_4c517518-6618-4ebe-a05a-3c668e2954a0 69168-338 HUMAN OTC DRUG Ibuprofen Pain reliever/fever reducer Ibuprofen 200 mg TABLET ORAL 20141222 ANDA ANDA091355 Allegiant Health IBUPROFEN 200 mg/1 69168-345_e3774f74-ee88-48f9-9745-012ab7b8a4f5 69168-345 HUMAN OTC DRUG Mucus Relief DM Immediate Release Dextromethorphan HBr and Guaifenesin TABLET ORAL 20141223 OTC MONOGRAPH FINAL part341 Allegiant Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 69168-346_3eab9688-5054-4280-b88c-fcf9de26a0d2 69168-346 HUMAN OTC DRUG Allergy Softgel Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20141215 OTC MONOGRAPH FINAL part341 Allegiant Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 69168-353_01d11093-e9d4-4786-91af-17060380d705 69168-353 HUMAN OTC DRUG Pain Relief Extra Strength Easy to Swallow Acetaminophen 500 mg TABLET ORAL 20141217 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN 500 mg/1 69168-354_0b2a2dac-7e5c-411b-bedb-87141a11d93d 69168-354 HUMAN OTC DRUG Mucus Relief D Immediate Release Guaifenesin and Phenylephrine HCl TABLET ORAL 20141223 OTC MONOGRAPH FINAL part341 Allegiant Health GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 69168-361_1b97ae91-7304-49f3-a5aa-38973bb61c49 69168-361 HUMAN OTC DRUG Naproxen All day relief for pain Naproxen Sodium 220 mg TABLET ORAL 20141223 ANDA ANDA090545 Allegiant Health NAPROXEN SODIUM 220 mg/1 69168-362_0f1e4e8d-41fe-483f-9e80-7d3969bb891a 69168-362 HUMAN OTC DRUG Naproxen Caplets All day relief for pain Naproxen Sodium 220 mg TABLET ORAL 20141223 ANDA ANDA090545 Allegiant Health NAPROXEN SODIUM 220 mg/1 69168-363_bd0caf34-91ef-4dd4-9d03-a48385ffceea 69168-363 HUMAN OTC DRUG Ibuprofen Liqui-gels Ibuprofen 200 mg CAPSULE, LIQUID FILLED ORAL 20141222 ANDA ANDA079205 Allegiant Health IBUPROFEN 200 mg/1 69170-102_e1b40b9c-e70b-410f-ab5c-3118425d041e 69170-102 HUMAN OTC DRUG LICE ICE NEEM OIL, TEA TREE OIL GEL TOPICAL 20140815 UNAPPROVED HOMEOPATHIC NATURALRX LLC AZADIRACHTA INDICA SEED OIL; TEA TREE OIL .937; .937 [hp_X]/100mL; [hp_X]/100mL 69174-125_cc2a6f91-531c-4d6c-9886-8166709070a3 69174-125 HUMAN OTC DRUG Tenzer Baby PETROLATUM JELLY TOPICAL 20120530 OTC MONOGRAPH FINAL part347 Collection 2000 PETROLATUM 99.7 g/100g 69174-126_685fa740-cc03-4508-b5a7-6a097d82597d 69174-126 HUMAN OTC DRUG Tenzer Baby PETROLATUM JELLY TOPICAL 20120530 OTC MONOGRAPH FINAL part347 Collection 2000 Cosmetics,Inc. PETROLATUM 100 g/100g 69176-025_7668b6d3-fdae-496e-a8ce-74edec75e56f 69176-025 HUMAN PRESCRIPTION DRUG Renovo Menthol and Capsaicin PATCH TOPICAL 20140925 UNAPPROVED DRUG OTHER TMIG, Inc. CAPSAICIN; MENTHOL .0375; 5 g/100g; g/100g 69179-490_6036adcd-8611-43ae-94d0-119ea85b024a 69179-490 HUMAN OTC DRUG HEM-EASY RELIEF Herbal Hemorrhoidal LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20140820 OTC MONOGRAPH FINAL part346 Batool Pharma International, Inc LIDOCAINE 45 mg/mL 69179-491_6eff1d34-9b36-45c6-814a-e28a1fd6399e 69179-491 HUMAN OTC DRUG HEM-EASY RELIEF Herbal Anti-Itch MAXIMUM ITCH RELIEF HYDROCORTISONE CREAM TOPICAL 20140827 OTC MONOGRAPH NOT FINAL part348 Batool Pharma International, Inc HYDROCORTISONE 10 mg/mL 69184-001_7fea3489-7ded-4ca2-a4c7-3e00aa0b2153 69184-001 HUMAN OTC DRUG Super BB All-In-1 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140917 OTC MONOGRAPH FINAL part352 Mei Shual Cosmetics Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 15; 10 mg/100mg; 1/100mg 69184-002_59525604-c133-4e46-9173-c74a40c26ef9 69184-002 HUMAN OTC DRUG Mineral Wear titanium dioxide, zinc oxide POWDER TOPICAL 20141208 OTC MONOGRAPH FINAL part352 Mei Shual Cosmetics Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 6; 4.2 g/100g; g/100g 69186-001_ff2aee16-3d78-430e-a439-a16d49691664 69186-001 HUMAN OTC DRUG Actiogen Acne Dots Treatment Acne Treatment PATCH TOPICAL 20140801 OTC MONOGRAPH FINAL part333D Actiogen Corp SALICYLIC ACID 2 mg/100mg 69190-111_a606020c-4f3f-4e4d-b965-4e45e9a89f58 69190-111 HUMAN OTC DRUG CURE ATHLETES FOOT UNDECYLENIC ACID OIL TOPICAL 20140901 OTC MONOGRAPH FINAL part333C R AND S RESEARCH UNDECYLENIC ACID 10 g/100g 69190-258_9a4d17c2-98fd-4301-960f-e3db4848a7bb 69190-258 HUMAN OTC DRUG BLUMJK PAIN RELIEF TROLAMINE SALICYLATE LIQUID TOPICAL 20140802 OTC MONOGRAPH NOT FINAL part348 R AND S RESEARCH TROLAMINE SALICYLATE 10 g/100g 69190-322_8981c6fa-0524-42f2-8e51-45fe03c04df3 69190-322 HUMAN OTC DRUG FUNGAL FREE NAILS EUCALYPTUS GLOBULUS LEAF, MELALEUCA ALTERNIFOLIA LEAF OIL TOPICAL 20140827 UNAPPROVED HOMEOPATHIC R AND S RESEARCH EUCALYPTUS GLOBULUS LEAF; MELALEUCA ALTERNIFOLIA LEAF 5; 5 g/100g; g/100g 69190-326_980b1be0-4ef2-4f6e-919d-7586ffaf154a 69190-326 HUMAN OTC DRUG FungiClear Natural EUCALYPTUS GLOBULUS LEAF, MELALEUCA ALTERNIFOLIA LEAF OIL TOPICAL 20140802 UNAPPROVED HOMEOPATHIC R AND S RESEARCH EUCALYPTUS GLOBULUS LEAF; MELALEUCA ALTERNIFOLIA LEAF 5; 5 g/100g; g/100g 69190-336_37429304-6ae3-45b1-b8e5-729ec0c99fa4 69190-336 HUMAN OTC DRUG Fungal Free Nails Natural EUCALYPTUS GLOBULUS LEAF, MELALEUCA ALTERNIFOLIA LEAF OIL TOPICAL 20140802 UNAPPROVED HOMEOPATHIC R AND S RESEARCH EUCALYPTUS GLOBULUS LEAF; MELALEUCA ALTERNIFOLIA LEAF 5; 5 g/100g; g/100g 69191-500_3e5d5843-6d2c-4e6e-ae3b-fe7a6b3461eb 69191-500 HUMAN OTC DRUG Dr. Richs Numbing LIDOCAINE GEL TOPICAL 20140827 OTC MONOGRAPH NOT FINAL part348 GenZ Online LLC LIDOCAINE 4 g/100g 69195-1001_02505212-2247-4de8-866d-fe5ac88ee6b2 69195-1001 HUMAN OTC DRUG Haben Herb CHLORPHENIRAMINE MALEATE CAPSULE ORAL 20140827 OTC MONOGRAPH FINAL part341 Beverly Hills Holdings Co,. Ltd. CHLORPHENIRAMINE MALEATE 1.25 mg/1 69196-1001_ce8c09a2-e08f-4830-9e12-c199e86599d6 69196-1001 HUMAN OTC DRUG Niagara S GLYCERIN SOAP TOPICAL 20140911 OTC MONOGRAPH FINAL part347 Sungwon Cosmetics GLYCERIN 1 g/100g 69196-2001_e7233e02-3272-46b6-b30f-13a33925cd69 69196-2001 HUMAN OTC DRUG Miracle of the Mose Hair Bar GLYCERIN SOAP TOPICAL 20140911 OTC MONOGRAPH FINAL part347 Sungwon Cosmetics GLYCERIN 1 g/100g 69197-001_3edb54c8-961a-4620-9375-cab11eb724e9 69197-001 HUMAN OTC DRUG MAX LAX CHERRY Magnesium citrate LIQUID ORAL 20140901 OTC MONOGRAPH NOT FINAL part334 Command Brands, LLC MAGNESIUM CITRATE 2.65 mg/100mL 69197-002_cd9c3fa5-bf5b-4e94-9a00-62b421930446 69197-002 HUMAN OTC DRUG MAX LAX LEMON Magnesium citrate LIQUID ORAL 20140901 OTC MONOGRAPH NOT FINAL part334 Command Brands, LLC MAGNESIUM CITRATE 2.65 mg/100mL 69198-700_0e4fd924-efec-4461-b42b-5eb93b1d7db0 69198-700 HUMAN OTC DRUG MANCORE MUSCLE MEND ROLL-ON PAIN RELIEVER HISTAMINE DIHYDROCHLORIDE LOTION TOPICAL 20140827 OTC MONOGRAPH NOT FINAL part348 R2 Distribution, LLC HISTAMINE DIHYDROCHLORIDE .6 mg/mL 69199-010_5d8624e1-eec9-494e-8370-49ea8b8a1bdd 69199-010 HUMAN OTC DRUG Milky Dress The White Platinum Dimethicone CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 JR Cosmetic Co., Ltd DIMETHICONE 1.62 mg/65mL 69201-241_0e833d42-3995-4ca5-b392-138cafaeac20 69201-241 HUMAN OTC DRUG Vine Vera Resveratrol Zinfandel Radiance Octinoxate, Homosalate, Octisilate, Oxybenzone and Avobenzone CREAM TOPICAL 20141003 OTC MONOGRAPH NOT FINAL part352 Vivo Per-lei, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 1.5; 6.2; 7.4; 5; 3.1 g/100g; g/100g; g/100g; g/100g; g/100g 69201-852_efe14f38-3320-41ee-9538-6019e6d2938a 69201-852 HUMAN OTC DRUG 24K Bio-Brightening Skin Tone Moisturizer SPF 30 Octinoxate, Homosalate, Octisilate, Oxybenzone and Avobenzone CREAM TOPICAL 20141003 OTC MONOGRAPH NOT FINAL part352 Vivo Per-lei, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 1.5; 6.2; 7.4; 5; 3.1 g/100g; g/100g; g/100g; g/100g; g/100g 69201-966_0246bcd5-2aff-47bc-8528-1aea6067ecc1 69201-966 HUMAN OTC DRUG 24K Bio-Brightening Dark Circle Eye SPF 30 Zinc Oxide and Titanium Oxide SOLUTION TOPICAL 20141003 OTC MONOGRAPH NOT FINAL part352 Vivo Per-lei, Inc. TITANIUM DIOXIDE; ZINC OXIDE 5; 10 g/100mL; g/100mL 69204-001_47448380-2c96-41b5-b691-86f8f4aa48cb 69204-001 HUMAN OTC DRUG Nasol Capsicum, Eucalyptus SPRAY NASAL 20140301 UNAPPROVED HOMEOPATHIC Natures Formulae Health Products Ltd. CAPSICUM; EUCALYPTUS GLOBULUS LEAF 4; 4 [hp_X]/30mL; [hp_X]/30mL 69207-0001_c3c54d7e-13b2-45cd-8eda-3b186e991efc 69207-0001 HUMAN OTC DRUG ESSENTIAL WEIGHT LOSS AMMONIUM BROMATUM, FUCUS VESICULOSUS, NATRUM SULPHURICUM, NICOTINAMIDUM, SPONGIA TOSTA, THIAMINUM HYDROCHLORICUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THYROIDINUM (BOVINE), CALCAREA CARBONICA, GRAPHITES LIQUID ORAL 20141203 UNAPPROVED HOMEOPATHIC Integrative Health Alliance AMMONIUM BROMIDE; FUCUS VESICULOSUS; GRAPHITE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; THIAMINE HYDROCHLORIDE; THYROID, BOVINE 3; 3; 12; 3; 12; 6; 6; 3; 3; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 69216-001_e2363d79-3c6d-479d-9e3a-ff61b8bec029 69216-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140901 UNAPPROVED MEDICAL GAS Stateserv Medical of Arizona OXYGEN 99 L/100L 69219-101_07d9fa3a-8e57-495c-91aa-6e029876d832 69219-101 HUMAN OTC DRUG PROTECTIVE MOISTURIZER SPF 15 ZINC OXIDE, OCTINOXATE LOTION TOPICAL 20141001 OTC MONOGRAPH FINAL part352 SCIENCE OF SKINCARE LLC OCTINOXATE; ZINC OXIDE 3.3; 4.2 g/100g; g/100g 69219-102_15fe749d-7629-4b94-8e73-e9e940a1e86a 69219-102 HUMAN OTC DRUG ECLIPSE SPF 50 ALL SHADES TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20141001 OTC MONOGRAPH FINAL part352 SCIENCE OF SKINCARE LLC TITANIUM DIOXIDE; ZINC OXIDE 5.2; 1.1 g/100g; g/100g 69219-103_844a73b3-9e3f-4a55-8b41-483f87c06a6a 69219-103 HUMAN OTC DRUG EXTREME PROTECT SPF 30 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20141001 OTC MONOGRAPH FINAL part352 SCIENCE OF SKINCARE LLC OCTINOXATE; ZINC OXIDE 5.5; 4.12 g/100g; g/100g 69221-101_97a9f3ef-645e-4211-9391-4e76ca6a67c3 69221-101 HUMAN OTC DRUG GermFree24 Health-care Personnel Handwash BENZALKONIUM CHLORIDE Health-care Personnel Handwash SOLUTION TOPICAL 20140920 OTC MONOGRAPH NOT FINAL part333E ZOONO USA, LLC BENZALKONIUM CHLORIDE 1.3 g/100mL 69221-201_415208fd-b96f-429e-8192-072c1d4e0417 69221-201 HUMAN OTC DRUG GermFree24 Antiseptic Handwash BENZALKONIUM CHLORIDE Health-care Personnel Handwash SOLUTION TOPICAL 20140920 OTC MONOGRAPH NOT FINAL part333E ZOONO USA, LLC BENZALKONIUM CHLORIDE 1.3 g/100mL 69222-000_26f5b55e-8a0b-4a6c-8dd0-f68a24f7b4a6 69222-000 HUMAN OTC DRUG whole health Hand Sanitizers 3-pack ETHYL ALCOHOL KIT 20140917 OTC MONOGRAPH NOT FINAL part333E Suzhou Jingying Daily Necessities Co., Ltd. 69223-000_e9b2fd44-cb77-4f2c-98f7-25289dc97eb1 69223-000 HUMAN OTC DRUG Colgate Anticavity Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20140922 OTC MONOGRAPH FINAL part355 Zhuhai Jenny's Choice Manufacturing Limited SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g 69224-1001_4b22d96e-ff3e-4621-a8d1-1568b90c5220 69224-1001 HUMAN OTC DRUG ATO ALL GLYCERIN LIQUID TOPICAL 20141017 OTC MONOGRAPH FINAL part347 GL BioTech GLYCERIN 2 g/100mL 69224-2001_5bc6c8aa-7b68-4a1b-96ef-6b47c4978327 69224-2001 HUMAN OTC DRUG AC ALL GLYCERIN LIQUID TOPICAL 20141017 OTC MONOGRAPH FINAL part347 GL BioTech GLYCERIN 2 g/100mL 69224-3001_7fa39a20-1da9-4810-a145-541095b074d1 69224-3001 HUMAN OTC DRUG Yeo Danbi GLYCERIN LIQUID TOPICAL 20141017 OTC MONOGRAPH FINAL part347 GL BioTech GLYCERIN 2 g/100mL 69225-1000_e50d75d0-b3e6-41d3-b335-969c9d0c7907 69225-1000 HUMAN OTC DRUG Antiseptic Bandages Benzalkonium chloride DRESSING TOPICAL 20140109 OTC MONOGRAPH NOT FINAL part333E Pharmaband BENZALKONIUM CHLORIDE .042 mg/1 69226-010_a02d6e27-8c77-4410-9777-1f6571a8a996 69226-010 HUMAN OTC DRUG REMAN HOMME SUN PROTECTION TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE STICK TOPICAL 20140930 OTC MONOGRAPH NOT FINAL part352 Pf Nature OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.54; 2.13; 1.66 g/22g; g/22g; g/22g 69231-001_6133d897-475d-429a-a4ae-6dc8b57180c8 69231-001 HUMAN OTC DRUG IQueen CCC Light Titanium Dioxide, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate CREAM TOPICAL 20140925 OTC MONOGRAPH NOT FINAL part352 KW ABSC, INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.75; 1.5; 4.25 mg/50mL; mg/50mL; mg/50mL 69231-002_1234462d-026d-409b-90ee-20c021b4211f 69231-002 HUMAN OTC DRUG IQueen CCC Medium Titanium Dioxide, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate CREAM TOPICAL 20140925 OTC MONOGRAPH NOT FINAL part352 KW ABSC, INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.75; 1.5; 4.25 mg/50mL; mg/50mL; mg/50mL 69231-003_8308d279-44f6-403b-a4bf-f5e75f97525d 69231-003 HUMAN OTC DRUG IQueen CCC Dark Titanium Dioxide, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate CREAM TOPICAL 20140925 OTC MONOGRAPH NOT FINAL part352 KW ABSC, INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.75; 1.5; 4.25 mg/50mL; mg/50mL; mg/50mL 69232-001_e4f02d2c-ebef-491d-82ad-3d9513889483 69232-001 HUMAN OTC DRUG Natural Epsom Salt magnesium sulfate POWDER TOPICAL 20141009 OTC MONOGRAPH NOT FINAL part334 Anhui Twowin Machinery Imp. & Exp. Co., Ltd. MAGNESIUM SULFATE 10 g/10g 69233-644_1842b5c5-3d44-4a06-bad3-ba922cb897fd 69233-644 HUMAN OTC DRUG Reliaderm METHYL SALICYLATE, MENTHOL, CAPSAICIN CREAM TOPICAL 20140625 OTC MONOGRAPH NOT FINAL part348 Icon Health Services, Llc CAPSAICIN; MENTHOL; METHYL SALICYLATE .035; 10; 25 g/100g; g/100g; g/100g 69234-003_9e83d0f8-c292-432c-b175-e1e332dbb98f 69234-003 HUMAN OTC DRUG RITUALS SMOOTH OPERATOR caring lip balm broad spectrum SPF15 sunscreen 4.8g AVOBENZONE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20140929 OTC MONOGRAPH NOT FINAL part352 Delarange Cosmetics B.V. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 30; 60; 60 mg/g; mg/g; mg/g 69235-310_629858bd-c07c-4ce6-8725-43b598bc36da 69235-310 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840911 ANDA ANDA062500 MHC Pharma, LLC DOXYCYCLINE HYCLATE 100 mg/1 69235-320_a233a01d-6859-4d95-b27e-589a614ae8b5 69235-320 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 MHC Pharma, LLC DOXYCYCLINE HYCLATE 100 mg/1 69235-350_629858bd-c07c-4ce6-8725-43b598bc36da 69235-350 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840911 ANDA ANDA062500 MHC Pharma, LLC DOXYCYCLINE HYCLATE 50 mg/1 69238-1101_db2c439a-2749-4d05-b7aa-cf653c499785 69238-1101 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20140401 ANDA ANDA078329 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 69238-1102_db2c439a-2749-4d05-b7aa-cf653c499785 69238-1102 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20140401 ANDA ANDA078329 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 69238-1103_db2c439a-2749-4d05-b7aa-cf653c499785 69238-1103 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20140401 ANDA ANDA078329 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 69238-1251_2d2c1a0f-49c6-4b74-a7a7-a26340d6f77c 69238-1251 HUMAN PRESCRIPTION DRUG Lopreeza estradiol/norethindrone acetate TABLET, FILM COATED ORAL 20141001 NDA AUTHORIZED GENERIC NDA020907 Amneal Pharmaceuticals of New York, LLC ESTRADIOL; NORETHINDRONE ACETATE 1; .5 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 69238-1252_2d2c1a0f-49c6-4b74-a7a7-a26340d6f77c 69238-1252 HUMAN PRESCRIPTION DRUG Lopreeza estradiol/norethindrone acetate TABLET, FILM COATED ORAL 20141001 NDA AUTHORIZED GENERIC NDA020907 Amneal Pharmaceuticals of New York, LLC ESTRADIOL; NORETHINDRONE ACETATE .5; .1 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] 69240-001_b2ea6d6c-4c3e-4b47-977a-ecee2e494fbb 69240-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20140901 NDA NDA205767 Acute Care Gases, Inc. OXYGEN 99 L/100L 69241-001_386a0834-1bdb-41ea-b46f-6d8b3df1c066 69241-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20140901 NDA NDA205849 RTA Pediatric Care Inc. OXYGEN 99 L/100L 69243-0610_52e7bb87-cebf-4c79-9631-b40cef0b7f2d 69243-0610 HUMAN OTC DRUG Germ Bloc Hand Sanitizer Benzalkonium Chloride LOTION TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A Willspeed Technologies LLC BENZALKONIUM CHLORIDE .0013 g/mL 69243-0710_3e8b9567-acad-4d91-9997-5dc8bbebf2f5 69243-0710 HUMAN OTC DRUG Germ Bloc Hand Sanitizer Foam Peppermint Benzalkonium Chloride LIQUID TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A Willspeed Technologies LLC BENZALKONIUM CHLORIDE .001 g/mL 69243-0810_9fdb21b9-7a73-40af-a1ef-2716f5fb7506 69243-0810 HUMAN OTC DRUG Germ Bloc Hand Sanitizer Benzalkonium Chloride SPRAY TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A Willspeed Technologies LLC BENZALKONIUM CHLORIDE .0013 g/mL 69244-1001_5ddb195a-0f97-4b8f-b208-645382e98d0a 69244-1001 HUMAN OTC DRUG Medicell Scalp GLYCERIN SHAMPOO TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Dr. Forhair GLYCERIN 2 g/100mL 69244-2001_75308357-d2f5-4807-9efe-5d8820b4a050 69244-2001 HUMAN OTC DRUG Plant Stemcell VEGF bFGF Tonic ALLANTOIN LIQUID TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Dr. Forhair ALLANTOIN .1 g/100mL 69244-3001_c80fb134-df25-46b2-a96d-4732a0a82b73 69244-3001 HUMAN OTC DRUG Plant Stemcell VEGF bFGF Ample GLYCERIN LIQUID TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Dr. Forhair GLYCERIN 3 g/100mL 69244-4001_5976c7d3-b7b1-40cb-87e9-22b0ee76fbb6 69244-4001 HUMAN OTC DRUG FOLLIGEN PYRITHIONE ZINC SHAMPOO TOPICAL 20141001 OTC MONOGRAPH FINAL part358H Dr. Forhair PYRITHIONE ZINC 2.1 g/100mL 69245-1001_ef10ac61-6ffa-40d8-9124-ece4507438f0 69245-1001 HUMAN OTC DRUG Chun-Shim Haedoksan REHMANNIA GLUTINOSA ROOT POWDER ORAL 20130708 UNAPPROVED DRUG OTHER HAMABIO Co., Ltd. REHMANNIA GLUTINOSA ROOT 5 g/100g 69246-001_094b3b08-a438-49db-93dd-e09fc24b7039 69246-001 HUMAN OTC DRUG Antiseptic Hand Cleansing Gel ETHYL ALCOHOL GEL TOPICAL 20140924 OTC MONOGRAPH NOT FINAL part333E Playaction LLC ALCOHOL 62 mL/100mL 69249-000_88c07515-1db8-4745-9721-6cbdd24a5469 69249-000 HUMAN OTC DRUG POVIOFIX Antiseptic POVIDONE-IODINE SOLUTION TOPICAL 20140925 OTC MONOGRAPH NOT FINAL part333E Naturel Medikal Kagit ve Gida San.Tic. Ltd Sti POVIDONE-IODINE 100 mg/mL 69250-661_03be8a96-c164-0e22-e054-00144ff8d46c 69250-661 HUMAN OTC DRUG Alcohol Prep Pad Alcohol Prep Pad SPONGE TOPICAL 20141030 UNAPPROVED DRUG OTHER BioMed Resource Inc. ISOPROPYL ALCOHOL 7 mL/10mL 69255-010_1b7c5434-ae74-46e6-91a6-2b096acb414a 69255-010 HUMAN OTC DRUG DR DENTAL CARE 750ML SODIUM FLUORIDE LIQUID TOPICAL 20140801 OTC MONOGRAPH FINAL part355 Jangin Pharm Co., Ltd. SODIUM FLUORIDE .15 mg/750mL 69255-020_7bfc899b-6f39-484b-8976-55b260f37744 69255-020 HUMAN OTC DRUG DR DENTAL CARE 250ML SODIUM FLUORIDE LIQUID TOPICAL 20140801 OTC MONOGRAPH FINAL part355 Jangin Pharm Co., Ltd. SODIUM FLUORIDE .05 mg/250mL 69255-030_9103dfa2-8347-4dc7-861d-6b0bb249796f 69255-030 HUMAN OTC DRUG DR DENTAL CARE 80ML SODIUM FLUORIDE LIQUID TOPICAL 20140801 OTC MONOGRAPH FINAL part355 Jangin Pharm Co., Ltd. SODIUM FLUORIDE .016 mg/80mL 69256-268_0ee6d9a4-a94b-4591-9011-fd04459cabcd 69256-268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part356 Harris Teeter, LLC HYDROGEN PEROXIDE 2.65 mL/100mL 69256-275_8caddaba-4b52-4114-acbd-4e5238705e23 69256-275 HUMAN OTC DRUG Rubbing Alcohol 70 Percent Isopropyl Isopropyl Alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A Harris Teeter, LLC ISOPROPYL ALCOHOL 70 mL/100mL 69257-110_e611c0fa-fda6-474b-af93-af4915cb702b 69257-110 HUMAN OTC DRUG Muscle Mist menthol, camphor SOLUTION TOPICAL 20141020 OTC MONOGRAPH NOT FINAL part348 Signature Formulations LLC CAMPHOR (SYNTHETIC); MENTHOL 2; 6 g/100mL; g/100mL 69259-1101_1ef11335-2546-4bce-b6e0-2f78c218b4bb 69259-1101 HUMAN OTC DRUG YOUR SKIN BUT BETTER FAIR TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20141025 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL 69259-1101_2c7219ef-380c-4929-acf8-02fd7739d223 69259-1101 HUMAN OTC DRUG YOUR SKIN BUT BETTER FAIR TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20141025 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL 69259-1102_92675096-a320-4dbd-b16f-3751859ed57a 69259-1102 HUMAN OTC DRUG YOUR SKIN BUT BETTER LIGHT TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20141021 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL 69259-2101_7cbdf959-ef9b-40e8-a6fb-911aa73ca3a2 69259-2101 HUMAN OTC DRUG CC VEIL BEAUTY FLUID FOUNDATION FAIR Titanium dioxide and zinc oxide EMULSION TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 12.1; 6.3 g/100mL; g/100mL 69259-2102_7cbdf959-ef9b-40e8-a6fb-911aa73ca3a2 69259-2102 HUMAN OTC DRUG CC VEIL BEAUTY FLUID FOUNDATION LIGHT Titanium dioxide and zinc oxide EMULSION TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 12.1; 6.3 g/100mL; g/100mL 69259-2104_7cbdf959-ef9b-40e8-a6fb-911aa73ca3a2 69259-2104 HUMAN OTC DRUG CC VEIL BEAUTY FLUID FOUNDATION MEDIUM Titanium dioxide and zinc oxide EMULSION TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 12.1; 6.3 g/100mL; g/100mL 69259-2201_7cbdf959-ef9b-40e8-a6fb-911aa73ca3a2 69259-2201 HUMAN OTC DRUG CC VEIL BEAUTY FLUID FOUNDATION TAN Titanium dioxide and zinc oxide EMULSION TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 12.1; 6.3 g/100mL; g/100mL 69259-2202_7cbdf959-ef9b-40e8-a6fb-911aa73ca3a2 69259-2202 HUMAN OTC DRUG CC VEIL BEAUTY FLUID FOUNDATION RICH Titanium dioxide and zinc oxide EMULSION TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 12.1; 6.3 g/100mL; g/100mL 69259-3300_4b22849f-3bed-4640-a215-ff5a1b71b2fe 69259-3300 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC EYE FAIR TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL 69259-3317_4b22849f-3bed-4640-a215-ff5a1b71b2fe 69259-3317 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC EYE LIGHT TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL 69259-3324_4b22849f-3bed-4640-a215-ff5a1b71b2fe 69259-3324 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC EYE MEDIUM TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL 69259-3331_4b22849f-3bed-4640-a215-ff5a1b71b2fe 69259-3331 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC EYE TAN TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL 69259-3348_4b22849f-3bed-4640-a215-ff5a1b71b2fe 69259-3348 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC EYE RICH TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL 69261-001_4010d26f-6591-4838-85ec-aebf3c57ddbb 69261-001 HUMAN OTC DRUG Quip SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20141001 OTC MONOGRAPH FINAL part355 Quip NYC Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g 69263-020_3d3e2f05-4483-40ef-bbf0-d6cf3b1f3c37 69263-020 HUMAN PRESCRIPTION DRUG Sinelee Menthol and Capsaicin PATCH TOPICAL 20141112 UNAPPROVED DRUG OTHER OakLock, LLC CAPSAICIN; MENTHOL .0375; 5 g/100g; g/100g 69264-014_4a8a9ec2-6fc1-4881-8a5b-a4f229933cfc 69264-014 HUMAN OTC DRUG Callus Removal Foot Pack Salicylic acid 0.19% PATCH TOPICAL 20141016 OTC MONOGRAPH FINAL part358B POLAROISIN INTERNATIONAL CO., LTD. SALICYLIC ACID .19 mg/1 69267-101_057842c3-d85b-3282-e054-00144ff88e88 69267-101 HUMAN PRESCRIPTION DRUG Atenolol Scopolamine Atenolol Scopolamine TABLET BUCCAL; ORAL; SUBLINGUAL; TRANSMUCOSAL 20141001 UNAPPROVED DRUG OTHER TPS ATENOLOL; SCOPOLAMINE HYDROBROMIDE 25; .25 mg/25.25mg; mg/25.25mg Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 69267-102_05797362-8cc2-35b7-e054-00144ff88e88 69267-102 HUMAN PRESCRIPTION DRUG Atenolol Scopolamine Atenolol Scopolamine TABLET ORAL 20141001 UNAPPROVED DRUG OTHER TPS ATENOLOL; SCOPOLAMINE HYDROBROMIDE 50; .5 mg/50.5mg; mg/50.5mg Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 69267-201_0579a12e-690c-3fa0-e054-00144ff88e88 69267-201 HUMAN PRESCRIPTION DRUG Propranolol Scopolamine Propranolol Scopolamine TABLET ORAL 20141001 UNAPPROVED DRUG OTHER TPS PROPRANOLOL HYDROCHLORIDE; SCOPOLAMINE HYDROBROMIDE 20; .25 mg/20.25mg; mg/20.25mg Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 69267-202_05797362-8cc7-35b7-e054-00144ff88e88 69267-202 HUMAN PRESCRIPTION DRUG Propranolol Scopolamine Propranolol Scopolamine TABLET ORAL 20141001 UNAPPROVED DRUG OTHER TPS PROPRANOLOL HYDROCHLORIDE; SCOPOLAMINE HYDROBROMIDE 40; .5 mg/40.5mg; mg/40.5mg Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] 69269-100_65ead756-de0f-4164-8b1b-732c93d47994 69269-100 HUMAN PRESCRIPTION DRUG Obagi Nu-Derm HYDROQUINONE CREAM TOPICAL 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 69269-101_6ec74b33-d4f9-495f-8a81-2abd2a575462 69269-101 HUMAN PRESCRIPTION DRUG Obagi Nu-Derm HYDROQUINONE CREAM TOPICAL 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 69269-103_6266f1a4-e31b-4f0a-81b5-0d88aaaaae5a 69269-103 HUMAN OTC DRUG Obagi TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20141014 OTC MONOGRAPH FINAL part352 YS PLUS CORPORATION TITANIUM DIOXIDE; ZINC OXIDE 20; 155 mg/mL; mg/mL 69269-104_26b273dc-a6b0-4134-a190-881397fc787a 69269-104 HUMAN OTC DRUG Obagi OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20141001 OTC MONOGRAPH FINAL part352 YS PLUS CORPORATION OCTINOXATE; ZINC OXIDE 75; 105 mg/g; mg/g 69269-105_8727dc18-aeff-49af-bbab-86e785abdfe3 69269-105 HUMAN PRESCRIPTION DRUG Obagi - C HYDROQUINONE LIQUID TOPICAL 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 69269-106_60b418a3-5276-4549-99cc-294c69fea1b9 69269-106 HUMAN PRESCRIPTION DRUG Obagi - C HYDROQUINONE LIQUID TOPICAL 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION HYDROQUINONE 40 mg/mL Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 69269-107_2b968de1-e4fd-431f-a30b-125112b8835b 69269-107 HUMAN OTC DRUG Obagi OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20141001 OTC MONOGRAPH FINAL part352 YS PLUS CORPORATION OCTINOXATE; ZINC OXIDE 75; 90 mg/mL; mg/mL 69269-108_67709305-19d3-455e-8bc5-b45417217f08 69269-108 HUMAN OTC DRUG Obagi OCTISALATE, OCTINOXATE, OXYBENZONE LOTION TOPICAL 20141001 OTC MONOGRAPH FINAL part352 YS PLUS CORPORATION OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 40 mg/mL; mg/mL; mg/mL 69269-110_89db11e9-fe33-4ce8-a1c7-68dc3090c1ee 69269-110 HUMAN OTC DRUG Obagi SALICYLIC ACID GEL TOPICAL 20141015 OTC MONOGRAPH FINAL part333D YS PLUS CORPORATION SALICYLIC ACID 20 mg/mL 69269-111_616f93e7-c209-47e5-89c8-746c839e4d18 69269-111 HUMAN OTC DRUG Obagi SALICYLIC ACID GEL TOPICAL 20141015 OTC MONOGRAPH FINAL part333D YS PLUS CORPORATION SALICYLIC ACID 20 mg/mL 69269-113_64e80a62-8a69-476f-bee2-f22393b847d2 69269-113 HUMAN OTC DRUG Obagi BENZOYL PEROXIDE LOTION TOPICAL 20141015 OTC MONOGRAPH FINAL part333D YS PLUS CORPORATION BENZOYL PEROXIDE 50 mg/mL 69269-114_42ffeff2-7c61-40b9-b91c-d23838216f11 69269-114 HUMAN OTC DRUG Obagi GLYCERIN CREAM TOPICAL 20141014 OTC MONOGRAPH FINAL part347 YS PLUS CORPORATION GLYCERIN 200 mg/mL 69269-116_4228c85d-e87f-48e5-b4ae-4f2759c0c24b 69269-116 HUMAN PRESCRIPTION DRUG Obagi Nu-Derm Sunfader HYDROQUINONE, OCTINOXATE, OXYBENZONE CREAM TOPICAL 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION HYDROQUINONE; OCTINOXATE; OXYBENZONE 40; 75; 55 mg/g; mg/g; mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 69269-121_8ec9667f-f95c-490c-8b38-4352259518e0 69269-121 HUMAN OTC DRUG Obagi OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH FINAL part352 YS PLUS CORPORATION OCTINOXATE; ZINC OXIDE 75; 105 mg/g; mg/g 69269-122_8f11dec7-cc47-439f-8501-125dea60c546 69269-122 HUMAN PRESCRIPTION DRUG Obagi - C HYDROQUINONE LIQUID TOPICAL 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION HYDROQUINONE 40 mg/mL Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] 69269-125_400dae03-77e9-4393-85e4-db94a5d981f3 69269-125 HUMAN OTC DRUG Obagi OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20141001 OTC MONOGRAPH FINAL part352 YS PLUS CORPORATION OCTINOXATE; ZINC OXIDE 75; 105 mg/g; mg/g 69269-126_69dd1e47-e34c-488c-8d18-e36c4b831623 69269-126 HUMAN OTC DRUG Obagi OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH FINAL part352 YS PLUS CORPORATION OCTINOXATE; ZINC OXIDE 75; 105 mg/g; mg/g 69269-128_2f6dc2a8-dceb-4726-a1a3-a364a4d4dabe 69269-128 HUMAN OTC DRUG Obagi AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20141001 OTC MONOGRAPH FINAL part352 YS PLUS CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 27.9; 30 mg/g; mg/g; mg/g; mg/g; mg/g 69269-129_2ca060fe-189d-4909-88e3-37f7c6aab2d0 69269-129 HUMAN OTC DRUG Obagi SALICYLIC ACID GEL TOPICAL 20141015 OTC MONOGRAPH FINAL part333D YS PLUS CORPORATION SALICYLIC ACID 20 mg/mL 69269-130_6bff70af-c4d0-439f-996b-858dc6b096cc 69269-130 HUMAN OTC DRUG Obagi AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20141001 OTC MONOGRAPH FINAL part352 YS PLUS CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 27.9; 30 mg/g; mg/g; mg/g; mg/g; mg/g 69269-131_440a5670-9dbf-4b47-9a41-202784a6bd74 69269-131 HUMAN OTC DRUG Obagi HOMOSALATE, OCTINOXATE, OCTOCRYLENE, ZINC OXIDE LOTION TOPICAL 20141001 OTC MONOGRAPH FINAL part352 YS PLUS CORPORATION HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 120; 75; 20; 49 mg/g; mg/g; mg/g; mg/g 69269-200_49e59d27-add3-4fb2-b4b8-141f5ea84858 69269-200 HUMAN OTC DRUG Obagi OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH FINAL part352 YS PLUS CORPORATION OCTINOXATE; ZINC OXIDE 75; 90 mg/mL; mg/mL 69269-243_4df0e640-bc62-4d40-a2b8-780e781a2a99 69269-243 HUMAN PRESCRIPTION DRUG Tretinoin Cream TRETINOIN CREAM TOPICAL 20141001 ANDA ANDA075264 YS PLUS CORPORATION TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 69269-300_277374be-6b16-4144-8221-3a85e4fa81bf 69269-300 HUMAN OTC DRUG Obagi AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20141001 OTC MONOGRAPH FINAL part352 YS PLUS CORPORATION AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 10; 75; 50; 50 mg/g; mg/g; mg/g; mg/g 69269-415_61ffab45-36e5-4c8c-b0c1-a5acadb3b6d4 69269-415 HUMAN PRESCRIPTION DRUG Obagi TRETINOIN CREAM TOPICAL 20141001 NDA AUTHORIZED GENERIC NDA017522 YS PLUS CORPORATION TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 69269-416_2ce692f7-346d-44b5-88d5-59c972fcedcf 69269-416 HUMAN PRESCRIPTION DRUG Obagi TRETINOIN CREAM TOPICAL 20141001 NDA AUTHORIZED GENERIC NDA017340 YS PLUS CORPORATION TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] 69269-511_4b2b3a2e-a19f-44bd-9166-489a12866c5a 69269-511 HUMAN OTC DRUG Obagi SALICYLIC ACID, BENZOYL PEROXIDE KIT 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION 69269-512_8b7311b4-15ef-4c92-81cd-3fb898fe2d20 69269-512 HUMAN OTC DRUG Obagi BENZOYL PEROXIDE, GLYCERIN KIT 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION 69269-520_4c9543eb-8848-474a-a29d-1fc3f473c374 69269-520 HUMAN PRESCRIPTION DRUG Obagi HYDROQUINONE, OCTINOXATE, ZINC OXIDE KIT 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION 69269-523_4d250dca-d5a3-49d2-8bbb-f848dbcc1989 69269-523 HUMAN PRESCRIPTION DRUG Obagi HYDROQUINONE, OCTINOXATE, ZINC OXIDE KIT 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION 69269-524_4e982198-63ad-4d22-b2a6-d35922bf4dab 69269-524 HUMAN PRESCRIPTION DRUG Obagi HYDROQUINONE KIT TOPICAL 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION 69269-525_692880ca-4f0c-482d-9e65-4cce2e01a544 69269-525 HUMAN OTC DRUG Obagi AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE KIT 20141001 OTC MONOGRAPH FINAL part352 YS PLUS CORPORATION 69269-800_820448e1-a5e9-4377-9fdc-84b19fed0c0e 69269-800 HUMAN OTC DRUG Obagi ASCORBIC ACID, ASCORBYL GLUCOSIDE LIQUID TOPICAL 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION ASCORBIC ACID; ASCORBYL GLUCOSIDE 3.6; 2.4 mg/30mL; mg/30mL 69269-815_4c44e34f-66bc-40b1-bd3f-8961af98b000 69269-815 HUMAN OTC DRUG Obagi ASCORBIC ACID, ASCORBYL GLUCOSIDE LIQUID TOPICAL 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION ASCORBIC ACID; ASCORBYL GLUCOSIDE 3; 1.5 g/30g; g/30g 69269-820_4ee45050-0425-4c9f-868a-417795d1df2d 69269-820 HUMAN OTC DRUG Obagi ASCORBIC ACID, ASCORBYL GLUCOSIDE LIQUID TOPICAL 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION ASCORBIC ACID; ASCORBYL GLUCOSIDE 3.6; 2.4 g/30g; g/30g 69269-830_83fbc9a4-d4fe-45b1-a406-ca3ab081ba15 69269-830 HUMAN OTC DRUG Obagi ARBUTIN CREAM TOPICAL 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION ARBUTIN 4.03 mg/57g 69269-831_2c7427da-2402-49e6-8f3d-a05e2506b69c 69269-831 HUMAN OTC DRUG Obagi Nu-Derm Clear Fx ARBUTIN CREAM TOPICAL 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION ARBUTIN 4.02 mg/57g 69269-840_6568b781-6026-4ba7-adf1-fb53742f71f4 69269-840 HUMAN OTC DRUG ObagiGentle Rejuvenati Gentle Rejuvenation KINETIN, ZEATIN LOTION TOPICAL 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION KINETIN; ZEATIN .03; .03 mg/30g; mg/30g 69274-001_08b1f358-f446-5080-e054-00144ff8d46c 69274-001 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 50% Isopropyl Alcohol LIQUID TOPICAL 20141125 OTC MONOGRAPH NOT FINAL part333A FOUR SEASONS TRADING INC ISOPROPYL ALCOHOL 50 mL/100mL 69274-002_08b28434-5da3-54b9-e054-00144ff88e88 69274-002 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 50% with Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20141125 OTC MONOGRAPH NOT FINAL part333A FOUR SEASONS TRADING INC ISOPROPYL ALCOHOL 50 mL/100mL 69274-003_08b28434-5db7-54b9-e054-00144ff88e88 69274-003 HUMAN OTC DRUG Vaporizing Chest Rub Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20141125 OTC MONOGRAPH NOT FINAL part348 FOUR SEASONS TRADING INC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.7; 1; 1 g/100g; g/100g; g/100g 69274-004_08b343dd-3ca9-6ff6-e054-00144ff88e88 69274-004 HUMAN OTC DRUG Blue Ice Topical Analgesic Menthol and Camphor GEL TOPICAL 20141125 OTC MONOGRAPH NOT FINAL part348 FOUR SEASONS TRADING INC CAMPHOR (SYNTHETIC); MENTHOL .5; 1 g/100g; g/100g 69278-100_c1513101-e753-42e4-ade4-13e653e48c4a 69278-100 HUMAN OTC DRUG Dr Cellapy SR Premium ascorbic acid KIT 20141010 UNAPPROVED DRUG OTHER GM Holdings Co., Ltd 69278-103_90904d1a-0be8-4337-932f-91c84cb0441f 69278-103 HUMAN OTC DRUG Cellapy A Repair Cream Ceramide 3 CREAM TOPICAL 20141015 UNAPPROVED DRUG OTHER GM Holdings Co., Ltd CERAMIDE 3 .1 1/100mL 69278-104_e80a9aaa-9240-4048-a38f-f421c6e72c55 69278-104 HUMAN OTC DRUG Cellapy A Repair Ceramide 3 LOTION TOPICAL 20141022 UNAPPROVED DRUG OTHER GM Holdings Co., Ltd CERAMIDE 3 .05 1/200mL 69278-105_9742929c-d8a3-49d3-a7e9-d4d8c390277e 69278-105 HUMAN OTC DRUG Cellapy MGF Hydro Gel Intense Mask Allantoin PATCH TOPICAL 20141022 OTC MONOGRAPH FINAL part347 GM Holdings Co., Ltd ALLANTOIN .5 1/25g 69281-010_4900940f-db08-4b55-aa1b-600920ea4eb6 69281-010 HUMAN OTC DRUG DHT X TONIC OATMEAL SOLUTION TOPICAL 20141001 OTC MONOGRAPH FINAL part347 IDOOGEN CO., LTD. OATMEAL .003 mg/55mL 69281-020_d7d315aa-12a6-4001-a323-2780ddecae42 69281-020 HUMAN OTC DRUG DHT X OATMEAL SHAMPOO TOPICAL 20141001 OTC MONOGRAPH FINAL part347 IDOOGEN CO., LTD. OATMEAL .025 g/360g 69281-030_3297e9a9-e215-487d-8e88-22e117469ca9 69281-030 HUMAN OTC DRUG DHT X HAIRLOSS Niacinamide SHAMPOO TOPICAL 20141101 UNAPPROVED DRUG OTHER IDOOGEN CO., LTD. NIACINAMIDE 1.08 g/360g 69282-001_86b0af44-48f7-4fcc-b6c0-731ce46f0ec9 69282-001 HUMAN OTC DRUG Nioxin Hair Regrowth Treatment for Women Minoxidil SOLUTION TOPICAL 20141101 ANDA ANDA075357 The Wella Corporation MINOXIDIL 2 g/100mL 69282-002_0e228336-a1b0-4bd4-b66c-0a1da606f1eb 69282-002 HUMAN OTC DRUG Nioxin Hair Regrowth Treatment Extra Strength for Men Minoxidil SOLUTION TOPICAL 20141101 ANDA ANDA075357 The Wella Corporation MINOXIDIL 5 g/100mL 69282-003_ffe33676-62ff-408a-afd0-f6af95bc0fb3 69282-003 HUMAN OTC DRUG Nioxin Scalp Optimizing Conditioner Advanced Thinning Pyrithione Zinc LOTION TOPICAL 20141110 OTC MONOGRAPH FINAL part358H The Wella Corporation PYRITHIONE ZINC .5 g/100mL 69282-004_bded8ad1-8ffb-411a-bd72-b4dc3e331ef1 69282-004 HUMAN OTC DRUG Nioxin Scalp Optimizing Cleanser Advanced Thinning Pyrithione Zinc SHAMPOO TOPICAL 20141110 OTC MONOGRAPH FINAL part358H The Wella Corporation PYRITHIONE ZINC 1 g/100mL 69286-001_f55f9e7d-4701-4887-9426-72714ed89a37 69286-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20141014 UNAPPROVED MEDICAL GAS Advantage Respiratory Services OXYGEN 900 mL/L 69288-001_ab5a9756-1232-48bf-bb5d-e03948c609cf 69288-001 HUMAN OTC DRUG NDM SCALP Biotin, Nicotinamide, DPanthenol, Pyrithione Zinc SHAMPOO TOPICAL 20141027 UNAPPROVED DRUG OTHER Damomedical Ltd. BIOTIN; DEXPANTHENOL; NIACINAMIDE; PYRITHIONE ZINC .168; 1.4; .84; .168 g/280mL; g/280mL; g/280mL; g/280mL 69288-002_980b8f7a-5108-4972-9b07-e35109d33c2e 69288-002 HUMAN OTC DRUG NDM SCALP Tonic Salicylic Acid, Nicotinamide LIQUID TOPICAL 20141027 UNAPPROVED DRUG OTHER Damomedical Ltd. NIACINAMIDE; SALICYLIC ACID .27; .45 g/90mL; g/90mL 69289-010_8b343f56-3ce2-4fd0-9c90-e61060840a96 69289-010 HUMAN OTC DRUG Max2 Eyelash Eyebrow Tonic Essence Gold OATMEAL SOLUTION TOPICAL 20140401 OTC MONOGRAPH FINAL part347 EYEMEE THE BEAUTY CO.,LTD OATMEAL .0007 mg/10mL 69290-140_431e550e-3a78-4295-8783-6262a3147eae 69290-140 HUMAN OTC DRUG Love and Beauty Coconut Vanilla Essence Antibacterial Scented Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141017 OTC MONOGRAPH NOT FINAL part333E Forever 21 ALCOHOL 17.98 mL/29mL 69290-141_c113a509-12b8-49c5-90c8-e11f433222c0 69290-141 HUMAN OTC DRUG Love and Beauty Floral Rose Essence Antibacterial Scented Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141017 OTC MONOGRAPH NOT FINAL part333E Forever 21 ALCOHOL 17.98 mL/29mL 69290-142_787a9514-fcdc-485e-ab15-db32659887ff 69290-142 HUMAN OTC DRUG Love and Beauty Grapefruit Citrus Essence Antibacterial Scented Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141017 OTC MONOGRAPH NOT FINAL part333E Forever 21 ALCOHOL 17.98 mL/29mL 69290-143_2c2cefc5-025e-49c5-b4ac-c6108107e355 69290-143 HUMAN OTC DRUG Love and Beauty Lemon Fresh Essence Antibacterial Scented Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141017 OTC MONOGRAPH NOT FINAL part333E Forever 21 ALCOHOL 17.98 mL/29mL 69290-144_b58ac9b7-1248-4e13-874d-b8b5fe83967a 69290-144 HUMAN OTC DRUG Love and Beauty Sweet Berry Essence Antibacterial Scented Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141017 OTC MONOGRAPH NOT FINAL part333E Forever 21 ALCOHOL 17.98 mL/29mL 69293-565_d34f72fd-4ef7-44fa-9fed-d3e4d12f4dc4 69293-565 HUMAN OTC DRUG Migrenol Acetaminophen, Caffeine TABLET ORAL 20141110 OTC MONOGRAPH NOT FINAL part343 Four Ventures Enterprises, Inc. ACETAMINOPHEN; CAFFEINE 500; 6 mg/1; mg/1 69294-1001_9980f7cd-f70b-46a2-b03b-5a52a3122da0 69294-1001 HUMAN OTC DRUG JINHANCHO SALICYLIC ACID SHAMPOO TOPICAL 20141017 OTC MONOGRAPH FINAL part358H The Anna SALICYLIC ACID .5 g/100mL 69299-101_a6a4d99b-290f-41c3-91d5-7375dccf096b 69299-101 HUMAN OTC DRUG QUICK DRY ACNE TREATMENT SULFUR LOTION TOPICAL 20141117 OTC MONOGRAPH FINAL part333D DR. THROWER'S SKINCARE, INC. SULFUR 10 g/100mL 69301-001_c933cccc-4d31-430a-9d08-654b23bce3e8 69301-001 HUMAN OTC DRUG Top Quality Mfg. Topical Anesthetic Benzocaine GEL DENTAL 20140501 OTC MONOGRAPH NOT FINAL part356 Top Quality Manufacturing, Inc. BENZOCAINE 200 mg/g 69301-002_acebcd30-cb6a-4827-901b-d4fa8a367600 69301-002 HUMAN OTC DRUG Top Quality Mfg. Topical Anesthetic Benzocaine GEL DENTAL 20140501 OTC MONOGRAPH NOT FINAL part356 Top Quality Manufacturing, Inc. BENZOCAINE 200 mg/g 69301-003_a46b6b37-8f51-4b49-93ff-4a3d33754987 69301-003 HUMAN OTC DRUG Top Quality Mfg. Topical Anesthetic Benzocaine GEL DENTAL 20140501 OTC MONOGRAPH NOT FINAL part356 Top Quality Manufacturing, Inc. BENZOCAINE 200 mg/g 69301-004_9d24ef78-82a0-4e5e-a6ed-b6b319d13223 69301-004 HUMAN OTC DRUG Top Quality Mfg. Topical Anesthetic Benzocaine GEL DENTAL 20140501 OTC MONOGRAPH NOT FINAL part356 Top Quality Manufacturing, Inc. BENZOCAINE 200 mg/g 69301-005_fa2557b1-29b6-41e0-b164-24a2070b0fe5 69301-005 HUMAN OTC DRUG Top Quality Mfg. Topical Anesthetic Benzocaine GEL DENTAL 20140501 OTC MONOGRAPH NOT FINAL part356 Top Quality Manufacturing, Inc. BENZOCAINE 200 mg/g 69301-006_a8535539-2121-461b-bdf8-97a5576a8c8e 69301-006 HUMAN OTC DRUG Top Quality Mfg. Topical Anesthetic Benzocaine GEL DENTAL 20140501 OTC MONOGRAPH NOT FINAL part356 Top Quality Manufacturing, Inc. BENZOCAINE 200 mg/g 69301-007_3bfcb37c-8a8f-4dcf-8889-98c90938a50a 69301-007 HUMAN OTC DRUG Top Quality Mfg. Topical Anesthetic Benzocaine GEL DENTAL 20140501 OTC MONOGRAPH NOT FINAL part356 Top Quality Manufacturing, Inc. BENZOCAINE 200 mg/g 69301-025_7220336e-2d2b-4762-95fe-5d01a0e121c3 69301-025 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g 69301-026_875b96b0-2c19-46ef-86da-69cd556e7f13 69301-026 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g 69301-027_656f8eac-157f-461e-8c89-3e3ac03e0b7b 69301-027 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g 69301-028_ca1b5714-b8b9-40b0-b50b-081001ba22ec 69301-028 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g 69301-029_2a6367a4-7c38-4f74-a52c-af2a1f749d58 69301-029 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g 69301-030_b9ec9899-3042-46c3-9b24-b3f8bdce5336 69301-030 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g 69301-031_029712b8-6de9-4568-8def-df4649cc391a 69301-031 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g 69301-032_b5edebf6-866e-481c-9d7a-8c763f0d0987 69301-032 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g 69301-033_86bb401e-66af-4b18-ab3e-dd4144f5aa98 69301-033 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g 69301-034_13873209-29fb-45a8-866c-ba301e4a7976 69301-034 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g 69301-050_644c66d1-27b7-4fe8-8686-c527298eb638 69301-050 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride AEROSOL, FOAM DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 1.5375 g/125g 69301-051_d348f3f1-d867-4922-bfff-d2236c0ef153 69301-051 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride AEROSOL, FOAM DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 1.5375 g/125g 69301-052_af95ce5b-a593-4a9d-b13e-e9515fc06d60 69301-052 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride AEROSOL, FOAM DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 1.5375 g/125g 69301-053_55d1df94-64fd-4bcb-80b5-e2452c0235f3 69301-053 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride AEROSOL, FOAM DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 1.5375 g/125g 69301-054_f386db71-9d5e-4e70-b954-2e68a9cdba08 69301-054 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride AEROSOL, FOAM DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 1.5375 g/125g 69301-055_3b6588fa-38c5-4cde-9abe-481e9bb38b8e 69301-055 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride AEROSOL, FOAM DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 1.5375 g/125g 69303-630_f3a56588-7965-4a55-83b6-a46a245dbe3c 69303-630 HUMAN OTC DRUG The Organic Pharmacy Cellular Protection Sunscreen SPF 30 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140715 OTC MONOGRAPH NOT FINAL part352 The organic pharmacy TITANIUM DIOXIDE; ZINC OXIDE 1; 10 g/100g; g/100g 69303-650_f3a56588-7965-4a55-83b6-a46a245dbe3c 69303-650 HUMAN OTC DRUG The Organic Pharmacy Cellular Protection Sunscreen SPF 50 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140715 OTC MONOGRAPH NOT FINAL part352 The organic pharmacy TITANIUM DIOXIDE; ZINC OXIDE 1; 12.5 g/100g; g/100g 69305-000_3899892d-2cff-450f-b573-f133bd51c76a 69305-000 HUMAN OTC DRUG Prolongz Damiana, Ginseng STRIP ORAL 20141024 UNAPPROVED HOMEOPATHIC Advanced Men's Institute LLC ASIAN GINSENG; TURNERA DIFFUSA LEAF 1; 1 [hp_X]/1001; [hp_X]/1001 69307-1024_05f1030d-1a9d-05df-e054-00144ff8d46c 69307-1024 HUMAN PRESCRIPTION DRUG Vanilla SilQ Barium Sulfate SUSPENSION ORAL 20141027 UNAPPROVED DRUG OTHER Genus Medical Technologies, LLC BARIUM SULFATE 21 mg/mL 69308-000_12d8696b-8ddb-4e17-abf7-0f093a59c3d7 69308-000 HUMAN OTC DRUG Prolongz Damiana, Ginseng STRIP ORAL 20141024 UNAPPROVED HOMEOPATHIC Guangdong Classic Health-Care Products Co., Ltd. ASIAN GINSENG; TURNERA DIFFUSA LEAF 1; 1 [hp_X]/1001; [hp_X]/1001 69309-1001_5b889b18-4310-44f4-8294-2b99e5a8235e 69309-1001 HUMAN OTC DRUG MIRACLE ATO GLYCERIN CREAM TOPICAL 20141022 OTC MONOGRAPH FINAL part347 Dr. Ha Skin Lab Co. GLYCERIN 2 g/100mL 69309-2001_7a72f61b-3778-47fd-b7aa-795eda6c8d3f 69309-2001 HUMAN OTC DRUG REMEMBER SERUM GLYCERIN LIQUID TOPICAL 20141022 OTC MONOGRAPH FINAL part347 Dr. Ha Skin Lab Co. GLYCERIN 2 g/100mL 69312-001_0acfcbe9-b3a6-56e8-e054-00144ff8d46c 69312-001 HUMAN OTC DRUG ISOPROPYL RUBBING ALCOHOL 50% Isopropyl Alcohol LIQUID TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part333A CONVENIENT CASH AND CARRY INC ISOPROPYL ALCOHOL 50 mL/100mL 69312-002_0a94f0c2-9982-2d45-e054-00144ff8d46c 69312-002 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 50% with Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part333A CONVENIENT CASH AND CARRY INC ISOPROPYL ALCOHOL 50 mL/100mL 69312-003_0a9505ff-941c-14a3-e054-00144ff8d46c 69312-003 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70% Isopropyl Alcohol LIQUID TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part333A CONVENIENT CASH AND CARRY INC ISOPROPYL ALCOHOL 70 mL/100mL 69312-004_0a94f0c2-9994-2d45-e054-00144ff8d46c 69312-004 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70% with Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part333A CONVENIENT CASH AND CARRY INC ISOPROPYL ALCOHOL 70 mL/100mL 69312-005_0a94f4af-1621-4e62-e054-00144ff8d46c 69312-005 HUMAN OTC DRUG Vaporizing Chest Rub Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part348 CONVENIENT CASH AND CARRY INC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.7; 1; 1 g/100g; g/100g; g/100g 69312-006_0a94f4af-1630-4e62-e054-00144ff8d46c 69312-006 HUMAN OTC DRUG Blue Ice Topical Analgesic Menthol and Camphor GEL TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part348 CONVENIENT CASH AND CARRY INC CAMPHOR (SYNTHETIC); MENTHOL .5; 1 g/100g; g/100g 69314-101_2f2f9a83-987b-4673-828c-31ac55f55872 69314-101 HUMAN OTC DRUG thermal-AID Headache Relief BRYONIA ALBA ROOT and TOXICODENDRON PUBESCENS LEAF CREAM TOPICAL 20140408 UNAPPROVED HOMEOPATHIC Pacific Shore Holdings, Inc. BRYONIA ALBA ROOT; TOXICODENDRON PUBESCENS LEAF 6; 6 [hp_X]/57g; [hp_X]/57g 69316-321_e0ba97d6-f857-4afe-9097-310b437f3377 69316-321 HUMAN OTC DRUG Mae by Damiva Calendula and Hamamelis SUPPOSITORY VAGINAL 20141110 UNAPPROVED HOMEOPATHIC Damiva Inc. CALENDULA OFFICINALIS FLOWER; HAMAMELIS VIRGINIANA LEAF 1; 6 [hp_X]/1; [hp_X]/1 69318-001_02133579-068a-40cf-a9e9-771d211334de 69318-001 HUMAN OTC DRUG AN12 Allantoin, Glycerin GEL TOPICAL 20141024 UNAPPROVED DRUG OTHER DoctorAN ALLANTOIN; GLYCERIN .3; 3 mg/150mL; mg/150mL 69319-001_57c687c3-82ed-4066-9553-2178da695fb5 69319-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20141020 UNAPPROVED MEDICAL GAS Med Way Medical OXYGEN 99 L/100L 69320-100_3487086f-31ed-45f1-af77-9d5ab3f2cb10 69320-100 HUMAN OTC DRUG Arhtri Plus Menthol,Eucalyptus Oil,Clove Oil SPRAY TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part348 Distributions Ar?mes d`Espagne Enr CLOVE OIL; EUCALYPTUS OIL; MENTHOL .25; .72; 2.5 g/100g; g/100g; g/100g 69327-1001_5457f375-87f9-4a74-ab2a-34961b28cd62 69327-1001 HUMAN OTC DRUG Fikia Marine Brightening Serum GLYCERIN LIQUID TOPICAL 20141025 OTC MONOGRAPH FINAL part347 Beauty Line Co., Ltd. GLYCERIN 2 g/100mL 69327-2001_7ff2ee7c-cef6-4f78-92c2-50871b530fad 69327-2001 HUMAN OTC DRUG Fikia Marine Delight Soothing Mist ALLANTOIN LIQUID TOPICAL 20141025 OTC MONOGRAPH FINAL part347 Beauty Line Co., Ltd. ALLANTOIN .1 g/100mL 69327-3001_89348ef4-5656-49ee-8ce6-17e609259c5c 69327-3001 HUMAN OTC DRUG Fikia Marine Eclipse Sun Block SPF 50 PA TITANIUM DIOXIDE CREAM TOPICAL 20141025 OTC MONOGRAPH FINAL part352 Beauty Line Co., Ltd. TITANIUM DIOXIDE 5 g/100mL 69327-4001_b36f5003-4d52-4688-a38e-3f259eabf398 69327-4001 HUMAN OTC DRUG Fikia Marine Natural Sun BB SPF 50 PA TITANIUM DIOXIDE CREAM TOPICAL 20141025 OTC MONOGRAPH FINAL part352 Beauty Line Co., Ltd. TITANIUM DIOXIDE 7.5 g/100mL 69327-5001_ea64286e-cc16-482f-9249-2b641d601bcd 69327-5001 HUMAN OTC DRUG Fikia Marine Velvet Whitening GLYCERIN CREAM TOPICAL 20141025 OTC MONOGRAPH FINAL part347 Beauty Line Co., Ltd. GLYCERIN 10 g/100mL 69327-6001_08f6985a-3476-47b8-beee-99a8cddce1e1 69327-6001 HUMAN OTC DRUG M-Rose Seaweed Sun BB SPF 50 PA TITANIUM DIOXIDE CREAM TOPICAL 20141025 OTC MONOGRAPH FINAL part352 Beauty Line Co., Ltd. TITANIUM DIOXIDE 5.269 g/100mL 69327-7001_661accce-3446-4ab4-b2c4-3b0db2173ae5 69327-7001 HUMAN OTC DRUG M-Rose Seaweed Lifting Revitalizing ALLANTOIN CREAM TOPICAL 20141025 OTC MONOGRAPH FINAL part347 Beauty Line Co., Ltd. ALLANTOIN 1 g/100mL 69327-8001_e789c3dd-0256-41bf-a0c1-fda808b152af 69327-8001 HUMAN OTC DRUG M-Rose Seaweed Essence Serum ALLANTOIN CREAM TOPICAL 20141025 OTC MONOGRAPH FINAL part347 Beauty Line Co., Ltd. ALLANTOIN 1 g/100mL 69327-9001_53c0f923-8980-4865-9f2a-a4e71e2fab77 69327-9001 HUMAN OTC DRUG M-Rose Seaweed Hydrogel Mask ALLANTOIN PATCH TOPICAL 20141025 OTC MONOGRAPH FINAL part347 Beauty Line Co., Ltd. ALLANTOIN .2 g/100g 69329-002_081c276b-f716-081e-e054-00144ff88e88 69329-002 HUMAN OTC DRUG Lidonexe LIDOCAINE, MENTHOL PATCH TOPICAL 20141110 OTC MONOGRAPH NOT FINAL part348 Patchwerx Labs, Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g 69329-013_07eec701-f57a-7394-e054-00144ff88e88 69329-013 HUMAN OTC DRUG MENDEX MENTHOL, CAPSAICIN PATCH TOPICAL 20141110 OTC MONOGRAPH NOT FINAL part348 Patchwerx Labs, Inc CAPSAICIN; MENTHOL .0375; 5 g/100g; g/100g 69329-017_07e9972b-b74c-4eb5-e054-00144ff88e88 69329-017 HUMAN PRESCRIPTION DRUG Lidenza Patch Lidocaine Hydrochloride PATCH TOPICAL 20131001 UNAPPROVED DRUG OTHER Patchwerx Labs, Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 69329-025_07eaac2c-60ae-578b-e054-00144ff8d46c 69329-025 HUMAN PRESCRIPTION DRUG Releevia Menthol and Capsaicin PATCH TOPICAL 20141117 UNAPPROVED DRUG OTHER Patchwerx Labs, Inc CAPSAICIN; MENTHOL .0375; 5 g/100g; g/100g 69332-001_bb0abd16-92d4-465c-8d17-e6130b3b4965 69332-001 HUMAN OTC DRUG Protection U.V. Broad Spectrum SPF 25 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20141102 OTC MONOGRAPH NOT FINAL part352 BR SAS TITANIUM DIOXIDE; ZINC OXIDE 25; 38 mg/mL; mg/mL 69335-001_ca41e282-80b8-42d7-bcc2-6cf01569ddd3 69335-001 HUMAN OTC DRUG Alpha BAC Stop E-2 CHLOROXYLENOL SOLUTION TOPICAL 20141104 OTC MONOGRAPH NOT FINAL part333A Alpha Chemical Services, Inc. CHLOROXYLENOL 1.5 g/100mL 69335-002_455a6718-b1e2-47a1-9346-09b66f84ab4c 69335-002 HUMAN OTC DRUG Alpha E-3 Instant Hand Sanitizer Ethanol SPRAY TOPICAL 20141104 OTC MONOGRAPH NOT FINAL part333E Alpha Chemical Services, Inc. ALCOHOL 710 g/1000mL 69336-200_afefd4b0-e489-458c-b2ac-387720185314 69336-200 HUMAN PRESCRIPTION DRUG Synvexia Lidocaine Hydrochloride and Menthol PATCH TOPICAL 20141114 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals,LLC LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 69336-201_d2a5f2a5-6c0c-46ea-a06e-a71950ce359f 69336-201 HUMAN PRESCRIPTION DRUG Synvexia TC Lidocaine Hydrochloride and Menthol CREAM TOPICAL 20141201 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 69336-300_3bf343b9-b399-4360-aec1-c272b5350860 69336-300 HUMAN PRESCRIPTION DRUG Durachol Durachol CAPSULE ORAL 20141116 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals,LLC CHOLECALCIFEROL; FOLIC ACID 3775; 1 [iU]/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 69336-400_4811c191-05e8-4dc4-85c0-9cedd8af1226 69336-400 HUMAN PRESCRIPTION DRUG Macuvex Macuvex CAPSULE ORAL 20141116 UNAPPROVED DRUG OTHER Sterling-knight Pharmaceuticals,LLC ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; COPPER; FOLIC ACID; LUTEIN; ZEAXANTHIN; ZINC OXIDE 200; 250; 1; 1; 5; 1; 40 [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 69336-500_fc406432-3581-4a20-ae71-0386b8ed47dd 69336-500 HUMAN PRESCRIPTION DRUG Adazin Capsaicin/Benzocaine/Lidocaine/Methyl Salicylate CREAM TOPICAL 20141203 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals, LLC BENZOCAINE; CAPSAICIN; LIDOCAINE; METHYL SALICYLATE 2; .035; 2; 1 g/100g; g/100g; g/100g; g/100g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 69338-001_7ac8f3c3-5c15-44fe-9b13-6f5af2c174f0 69338-001 HUMAN OTC DRUG FreshDent Kids Strawberry Anticavity Tooth Sodium Fluoride PASTE, DENTIFRICE DENTAL 20141106 OTC MONOGRAPH FINAL part355 FreshDent LLC SODIUM FLUORIDE .65 mg/g 69338-002_a5acc4f6-b53f-4a17-a889-ef681cfdf27b 69338-002 HUMAN OTC DRUG FreshDent Cavity Protection Anticavity SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20141106 OTC MONOGRAPH FINAL part355 FreshDent LLC SODIUM MONOFLUOROPHOSPHATE .85 mg/g 69342-001_071433cd-3730-468f-88a4-b428bd259fc0 69342-001 HUMAN OTC DRUG Dr. Selby Curative Diaper Rash and Skin Protectant ZINC OXIDE OINTMENT TOPICAL 20141030 OTC MONOGRAPH FINAL part347 Tactical Products International, LLC ZINC OXIDE 65 mg/g 69343-121_0b6ae4b6-dd4c-4ca7-9ad5-552cb250f10d 69343-121 HUMAN OTC DRUG Elyptol Antimicrobial Hand Gel Ethanol GEL TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part333A Elyptol Inc. ALCOHOL 7 mL/10mL 69343-221_5a330797-433e-4722-9218-b752a8b54ce6 69343-221 HUMAN OTC DRUG Elyptol Antimicrobial Rub Ethanol SOLUTION TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part333A Elyptol Inc. ALCOHOL 7 mL/10mL 69346-1001_babab33c-5f4c-466d-97ba-cee6c5f2d32d 69346-1001 HUMAN OTC DRUG WELLAGE POST PROCEDURE GLYCERIN CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 HUGEL PHARMA CO.,LTD. GLYCERIN 5 g/100mL 69346-2001_375cdc70-f1fd-41ca-a7e1-946e34d2c310 69346-2001 HUMAN OTC DRUG WELLAGE DEEP LAYER MOISTURIZER SLEEPING MASK GLYCERIN CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 HUGEL PHARMA CO.,LTD. GLYCERIN .2 g/100mL 69346-3001_11705090-d00d-41d1-ba71-369ab35fe21b 69346-3001 HUMAN OTC DRUG B BIND REJUVENATING NEOENDORPHIN MASK PACK GLYCERIN LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part347 HUGEL PHARMA CO.,LTD. GLYCERIN 10 g/100g 69348-100_b27e1b3d-0b34-4f32-a775-bb4deb3e22ec 69348-100 HUMAN OTC DRUG BSafe Instant Foaming Hand Sanitizer Benzalkonium Chloride AEROSOL, FOAM TOPICAL 20141204 OTC MONOGRAPH NOT FINAL part333E Med-Dev Corporation BENZALKONIUM CHLORIDE 1 mg/1000mL 69349-100_0888d96b-76a8-0d18-e054-00144ff8d46c 69349-100 HUMAN OTC DRUG FOUNDATION BALANCED SATIN FINISH SPF15 TITANIUM DIOXIDE LIQUID TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 Modern Beauty OCTINOXATE; TITANIUM DIOXIDE 2.5; 10 mg/mL; mg/mL 69351-010_8dcdacbb-11f3-4f73-a24a-45eac4b3e2d2 69351-010 HUMAN OTC DRUG SOOSUL ESSENCE ALLANTOIN CREAM TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Sang Hwang Mi-in Co., Ltd. ALLANTOIN .28 mg/40mL 69351-020_598018af-49e1-41c4-9a1c-4deeb9e5faaa 69351-020 HUMAN OTC DRUG SOOSUL GINSENG DIMETHICONE CREAM TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Sang Hwang Mi-in Co., Ltd. DIMETHICONE 1.2 g/60g 69351-030_8225def9-211e-40df-834a-80cf32c77b21 69351-030 HUMAN OTC DRUG SOOSUL WHITENING SLEEPING PACK DIMETHICONE CREAM TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Sang Hwang Mi-in Co., Ltd. DIMETHICONE 1.44 g/120g 69352-010_672f88f0-5d75-4cc0-9703-822a1fd618ff 69352-010 HUMAN OTC DRUG AMARTE NATURAL FINISH BB Titanium Dioxide, Octinoxate CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 AMARTEINTERNATIONAL CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 2; 2.8 mg/40mL; mg/40mL 69352-020_58ef885c-a5d3-43f6-9836-28af1229416d 69352-020 HUMAN OTC DRUG AMARTE ULTRA VEIL ULTRA LIGHT SUNSCREEN FLUID Octinoxate, Titanium Dioxide, Octisalate, Zinc Oxide CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 AMARTEINTERNATIONAL CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 4.9; 3.5; 3.78; 2.1 mg/70mL; mg/70mL; mg/70mL; mg/70mL 69353-001_89eae280-f8ae-45a8-9e09-aa90c970c6c7 69353-001 HUMAN OTC DRUG Singiso Red Ginseng TABLET ORAL 20141115 UNAPPROVED DRUG OTHER FDA TRADING CO.,LTD. ASIAN GINSENG .125 g/1 69356-001_fcd12a70-6a42-4603-8f8a-b00540e77c1d 69356-001 HUMAN OTC DRUG GAUKE Alcohol Prep Pad ISOPROPYL ALCOHOL PATCH TOPICAL 20141124 OTC MONOGRAPH NOT FINAL part333A Gauke Healthcare (Hubei) Co., Ltd ISOPROPYL ALCOHOL 70 g/100g 69356-002_7bea6cbb-8b1d-4a37-895f-ddc436a48f09 69356-002 HUMAN OTC DRUG GAUKE Antiseptic Towelette Benzalkonium Chloride PATCH TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part333A Gauke Healthcare (Hubei) Co., Ltd BENZALKONIUM CHLORIDE .133 g/100g 69356-003_5a570742-121f-4faf-b8d3-dcaefe402115 69356-003 HUMAN OTC DRUG GAUKE Antiseptic Povidone-Iodine Prep Pad POVIDONE-IODINE PATCH TOPICAL 20141124 OTC MONOGRAPH FINAL part333C Gauke Healthcare (Hubei) Co., Ltd POVIDONE-IODINE 10 g/100g 69356-004_d5360b72-2518-45ba-ba54-e7953b488879 69356-004 HUMAN OTC DRUG GAUKE Sting Relief Pad BENZOCAINE, ISOPROPYL ALCOHOL PATCH TOPICAL 20141124 OTC MONOGRAPH NOT FINAL part333A Gauke Healthcare (Hubei) Co., Ltd BENZOCAINE; ISOPROPYL ALCOHOL 6; 60 g/100g; g/100g 69358-0001_4c50d980-5301-4830-814e-311f69550dd6 69358-0001 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20141112 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL 69358-0002_0273254a-bbbc-4a71-af37-4b04fc452571 69358-0002 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20141112 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL 69358-0003_a162f7fd-3113-4132-881d-15d020ebfe59 69358-0003 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20141112 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL 69358-0004_c1de95a1-c4b6-46ee-98c5-62d519198075 69358-0004 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20141112 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL 69358-0005_fd6c93aa-fa04-4088-8c06-20f63ce24002 69358-0005 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20141112 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL 69358-0006_49cf4cd6-7df1-4b74-9da4-dc62ea382096 69358-0006 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20141112 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL 69358-0007_f23c99a9-4ec4-4c0d-a9d9-ddcb8bf49626 69358-0007 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20141112 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL 69362-250_ac1a9e79-eb02-44fe-80e9-664c0feee1a8 69362-250 HUMAN OTC DRUG GREEN BAMBOO MENTHOL CREAM TOPICAL 20141110 OTC MONOGRAPH NOT FINAL part348 Balance Center, Inc. MENTHOL 5 g/100g 69379-016_093efd77-4070-2006-e054-00144ff88e88 69379-016 HUMAN PRESCRIPTION DRUG Velma Pain Relief Patch Velma Pain Relief Patch PATCH TOPICAL 20141118 UNAPPROVED DRUG OTHER Home Aide Diagnostics, Inc. LIDOCAINE; MENTHOL; METHYL SALICYLATE 4; 2; 16 g/100g; g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 69379-037_093edffd-e151-5f8e-e054-00144ff8d46c 69379-037 HUMAN PRESCRIPTION DRUG Silvera Pain Relief Patch Silvera Pain Relief Patch PATCH TOPICAL 20141118 UNAPPROVED DRUG OTHER Home Aide Diagnostics, Inc. CAPSAICIN; LIDOCAINE; MENTHOL .0375; 1; 5 g/100g; g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 69381-2500_e19f65cd-0b11-410c-aa62-2d332c9339e2 69381-2500 HUMAN OTC DRUG Raw Ice menthol GEL TOPICAL 20141218 OTC MONOGRAPH NOT FINAL part348 Rescue Dog Health MENTHOL 3.5 mg/L 69381-2501_7891d767-c934-4e5f-ac35-2e7c4d04ad81 69381-2501 HUMAN OTC DRUG Raw Heat menthol GEL TOPICAL 20141218 OTC MONOGRAPH NOT FINAL part348 Rescue Dog Health MENTHOL 3.5 mg/L 69384-010_a2ef22ac-00fa-47d8-8fe9-b148a04e275a 69384-010 HUMAN OTC DRUG HAIRJOY PYRITHIONE ZINC SHAMPOO TOPICAL 20141001 OTC MONOGRAPH FINAL part358H HAIRJOY PYRITHIONE ZINC 6 mg/300mL 69384-020_2692f18d-8afe-4258-97db-d61e48c9e7b1 69384-020 HUMAN OTC DRUG HAIRJOY TONIC Allantoin SOLUTION TOPICAL 20141001 OTC MONOGRAPH FINAL part347 HAIRJOY ALLANTOIN .96 mg/120mL 69388-1001_e81880b1-eb47-4a06-92fd-727a780c864e 69388-1001 HUMAN OTC DRUG LANCELL HUITOMO HAIR LOSS PREVENTION HAIR GROWER CLEAN FORMULA PYRITHIONE ZINC LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part358H Lancell Bio Co., Ltd. PYRITHIONE ZINC 2.1 g/100mL 69388-2001_ea13edcf-20dc-44d9-aace-84a33da79c5b 69388-2001 HUMAN OTC DRUG LANCELL HUITOMO HAIR LOSS PREVENTION HAIR GROWING TONIC SALICYLIC ACID LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part358H Lancell Bio Co., Ltd. SALICYLIC ACID .5 g/100mL 69388-3001_5a514bd1-616b-4187-8914-7426107f5880 69388-3001 HUMAN OTC DRUG HUITOMI GLYCERIN CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Lancell Bio Co., Ltd. GLYCERIN 5 g/100mL 69388-4001_cb526852-6c4d-4468-a97f-726165f4b10d 69388-4001 HUMAN OTC DRUG HUITOMI SLIMMING SPORTS MENTHOL GEL TOPICAL 20141101 OTC MONOGRAPH FINAL part341 Lancell Bio Co., Ltd. MENTHOL .3 g/100mL 69388-5001_4dabaab6-b0ba-4a7b-96db-b53ded67c014 69388-5001 HUMAN OTC DRUG HUITOMI SERUM GLYCERIN LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Lancell Bio Co., Ltd. GLYCERIN 5 g/100mL 69402-011_09e4b381-5934-58c3-e054-00144ff8d46c 69402-011 HUMAN OTC DRUG BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20141210 OTC MONOGRAPH NOT FINAL part333E SANI PRODUCTS INC. BENZALKONIUM CHLORIDE .13 g/mL 69402-012_0a1a4ca8-e3fa-161c-e054-00144ff8d46c 69402-012 HUMAN OTC DRUG BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20141213 OTC MONOGRAPH NOT FINAL part333E SANI PRODUCTS INC. BENZALKONIUM CHLORIDE .13 g/mL 69410-0001_f08d9c42-e1fe-41a7-98d1-3bbf2dcb5490 69410-0001 HUMAN OTC DRUG Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20141126 OTC MONOGRAPH NOT FINAL part333E PrimeCare + Inc. ALCOHOL 75 mL/100mL 69414-0001_be0b8d9b-00da-4937-9be2-81ee6dc2ac33 69414-0001 HUMAN OTC DRUG LIVER ALIGN CHELIDONIUM MAJUS, CHOLESTERINUM, ARSENICUM ALBUM, BELLADONNA, LYCOPODIUM CLAVATUM, TARENTULA HISPANA LIQUID ORAL 20141210 UNAPPROVED HOMEOPATHIC Evolution ARSENIC TRIOXIDE; ATROPA BELLADONNA; CHELIDONIUM MAJUS; CHOLESTEROL; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA 1; 1; 3; 30; 1; 10 [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL 69414-0002_86ca31e2-0e95-43fa-bbcf-a3151ca6b362 69414-0002 HUMAN OTC DRUG GALLBLADDER ALIGN FEL TAURI, CHIONANTHUS VIRGINICA, ARSENICUM ALBUM, NUX VOMICA, PLATINUM METALLICUM LIQUID ORAL 20141211 UNAPPROVED HOMEOPATHIC Evolution ARSENIC TRIOXIDE; BOS TAURUS BILE; CHIONANTHUS VIRGINICUS BARK; PLATINUM; STRYCHNOS NUX-VOMICA SEED 1; 3; 30; 1; 1 [hp_M]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL 69418-001_09763398-b7b1-0532-e054-00144ff8d46c 69418-001 HUMAN OTC DRUG AmeriPatch menthol and capsaicin PATCH TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part348 Meds Direct Rx of NY LLC CAPSAICIN; MENTHOL .0375; 5 g/100g; g/100g 69422-1001_b3242b0e-32da-433d-9597-1687f264b3c1 69422-1001 HUMAN OTC DRUG FACIAL LIFTING ALLANTOIN GEL TOPICAL 20141208 OTC MONOGRAPH FINAL part347 General Bio Co., Ltd. ALLANTOIN .1 g/100mL 69422-2001_301c6f5d-af3b-4fa3-8991-8c58023df3c6 69422-2001 HUMAN OTC DRUG VFB BIO PEEL ALUMINUM OXIDE POWDER TOPICAL 20141209 UNAPPROVED DRUG OTHER General Bio Co., Ltd. ALUMINUM OXIDE 6.5 mg/g 69422-3001_30d69684-4534-4ed3-a16f-239e63cc2709 69422-3001 HUMAN OTC DRUG AB DUO WHITENING A GLYCERIN SOLUTION TOPICAL 20141208 OTC MONOGRAPH FINAL part347 General Bio Co., Ltd. GLYCERIN 10 g/100mL 69422-4001_f610c1d9-3e70-47cb-93f5-fd3b40b62246 69422-4001 HUMAN OTC DRUG P9 PHOTO CLEANSER GLYCERIN SOLUTION TOPICAL 20141208 OTC MONOGRAPH FINAL part347 General Bio Co., Ltd. GLYCERIN 69.8 g/100mL 69422-5001_61840956-ea63-4855-b862-223d6327a39d 69422-5001 HUMAN OTC DRUG HYDRO H ARBUTIN SOLUTION TOPICAL 20141209 UNAPPROVED DRUG OTHER General Bio Co., Ltd. ARBUTIN 2.5 mg/mL 69422-6001_5721e7fd-5943-4338-8e15-9ac623b6eb2d 69422-6001 HUMAN OTC DRUG POST CARE ALLANTOIN SOLUTION TOPICAL 20141208 OTC MONOGRAPH FINAL part347 General Bio Co., Ltd. ALLANTOIN .1 g/100mL 69423-002_75b3351a-92c2-4958-bb9a-57066c86ab12 69423-002 HUMAN OTC DRUG Secret Clinical Strength Smooth ooh la la lavender scent Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g 69423-003_960c9896-0d0a-4e58-9469-3d14e4fee402 69423-003 HUMAN OTC DRUG Secret Clinical Strength Smooth Sport Fresh Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g 69423-004_dc85c3b1-d7f0-43b8-b074-46c53472639e 69423-004 HUMAN OTC DRUG Secret Clinical Strength Smooth Light and Fresh Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g 69423-006_a9bd0d44-74ec-408a-86ce-d414c2a97385 69423-006 HUMAN OTC DRUG Secret Clinical Strength Smooth Mean Stinks Fearlessly Fresh Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g 69423-007_3921c827-faa8-4055-bb93-f85337f70d71 69423-007 HUMAN OTC DRUG Secret Clinical Strength Smooth Calming Aloe Scent Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g 69425-001_ff0c3001-f76a-46ce-9d33-12f317d5ae76 69425-001 HUMAN OTC DRUG antibacterial Hand Sanitizing wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333A Wuhan Bright Paper Factory BENZALKONIUM CHLORIDE .115 g/100g 69439-1001_35142eae-2c5c-4ae8-bbe0-79755bcf21cb 69439-1001 HUMAN OTC DRUG DR ANGIO Glycerin POWDER TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part334 Angio Lab Co., Ltd. GLYCERIN 8 g/100g 69439-2001_1d0a2717-7f3a-4810-af97-35b6750e2707 69439-2001 HUMAN OTC DRUG OB-X Glycerin POWDER TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part334 Angio Lab Co., Ltd. GLYCERIN 8 g/100g 69440-001_29323b3e-f2ef-47e8-9529-6e970652ca63 69440-001 HUMAN PRESCRIPTION DRUG Pain Relief Patch MENTHOL, CAPSAICIN PATCH TOPICAL 20141201 UNAPPROVED DRUG OTHER Binger Consulting Corporation CAPSAICIN; MENTHOL, UNSPECIFIED FORM .0375; 5 g/100g; g/100g 69440-002_854b9500-e9a6-48ba-996c-b90eeafd3bc1 69440-002 HUMAN PRESCRIPTION DRUG Pain Relief Patch LIDOCAINE, MENTHOL PATCH TOPICAL 20141201 UNAPPROVED DRUG OTHER Binger Consulting Corporation LIDOCAINE; MENTHOL, UNSPECIFIED FORM 5; 1 g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 69440-003_212b154d-7b2e-4346-be11-4931f05dcd67 69440-003 HUMAN PRESCRIPTION DRUG Scar Patch ALLANTOIN, LIDOCAINE, PETROLATUM PATCH TOPICAL 20141201 UNAPPROVED DRUG OTHER Binger Consulting Corporation ALLANTOIN; LIDOCAINE; PETROLATUM 2; 5; 30 g/100g; g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 69444-010_6cea476f-1297-4df7-9a11-cc34f1396b00 69444-010 HUMAN OTC DRUG Seo Sa Hyang Daily Moisture E Tox OATMEAL CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Ltd.SEO SA HYANG OATMEAL .015 g/150g 69449-1001_1ea4d8e4-9c9d-411c-b543-c9cb1d9ea0d2 69449-1001 HUMAN OTC DRUG REAL SUMMER SODIUM CHLORIDE PATCH TRANSDERMAL 20141208 OTC MONOGRAPH FINAL part349 Kayone SODIUM CHLORIDE .03 g/g 69454-001_a66f71fa-517d-4ded-a492-4b4ae8344f54 69454-001 HUMAN OTC DRUG Timeless Anti-Aging BB Broad Spectrum SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20141212 OTC MONOGRAPH NOT FINAL part352 JuCa L.L.C AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g 69455-101_40a73778-208a-4382-a274-7289d3644675 69455-101 HUMAN OTC DRUG DRUNK ELEPHANT UMBRA SHEER DEFENSE SPF-30 ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Drunk Elephant Distributors, LLC ZINC OXIDE 20 g/100g 69456-227_ba1c68c3-4fc5-4c57-a732-cc41711888d2 69456-227 HUMAN OTC DRUG BioBlast Pain Relief MENTHOL GEL TOPICAL 20141211 OTC MONOGRAPH NOT FINAL part348 SMART MEDICAL SUPPLIERS INC. MENTHOL 100 mg/mL 69463-1001_b48600d6-12c6-499e-9bdc-5b0e7ac6451c 69463-1001 HUMAN OTC DRUG Mecell Rose Coenzyme Q10 Serum Mask Pack GLYCERIN LIQUID TOPICAL 20141208 OTC MONOGRAPH FINAL part347 TERAECO GLYCERIN .03 g/g 69463-2001_1088daa2-18b3-4882-9a9e-18b04817957f 69463-2001 HUMAN OTC DRUG Mecell Red Ginseng Collagen 3D Mask Pack GLYCERIN LIQUID TOPICAL 20141208 OTC MONOGRAPH FINAL part347 TERAECO GLYCERIN .03 g/g 69480-001_ee660751-0895-47eb-8c56-147ee740ebd5 69480-001 HUMAN OTC DRUG Savannah First Aid Antiseptic Moist Towelette BENZALKONIUM CHLORIDE PATCH TOPICAL 20141223 OTC MONOGRAPH NOT FINAL part333A JRMI Ltd. BENZALKONIUM CHLORIDE .13 g/100g 69491-060_cad12bdd-bec9-4db6-b2e2-d1c8c4f17d0d 69491-060 HUMAN OTC DRUG Colgate SODIUM FLUORIDE PASTE DENTAL 20141203 OTC MONOGRAPH FINAL part355 Buzz Products Pty., Ltd SODIUM FLUORIDE 7.6 mg/g 69491-831_d980a4e5-2757-40fd-a774-bf693cc32caa 69491-831 HUMAN OTC DRUG Crest SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20141223 OTC MONOGRAPH FINAL part355 Buzz Products Pty., Ltd SODIUM FLUORIDE 1.5 mg/g 69502-500_417de836-aaf8-486c-ba9c-84aeb25b889e 69502-500 HUMAN OTC DRUG Touchless Care Antifungal MICONAZOLE NITRATE LIQUID TOPICAL 20141229 OTC MONOGRAPH FINAL part333C Crawford Healthcare, Inc. MICONAZOLE NITRATE 2 g/100g 69502-501_9b9214c6-0740-4cab-a8ae-ef599c735709 69502-501 HUMAN OTC DRUG Touchless Care CLEAR PROTECTANT DIMETHICONE SPRAY TOPICAL 20141229 OTC MONOGRAPH FINAL part347 Crawford Healthcare, Inc. DIMETHICONE 20 g/100g 69502-502_366a1999-118d-4a47-9ecc-bdb59a125181 69502-502 HUMAN OTC DRUG Touchless Care FIRST AID ANTIBIOTIC BACITRACIN SPRAY TOPICAL 20141229 OTC MONOGRAPH FINAL part333B Crawford Healthcare, Inc. BACITRACIN 500 [USP&apos'U]/g 69502-503_f2a5beb4-83a6-45d6-8341-713c8154b73a 69502-503 HUMAN OTC DRUG Touchless Care ZINC OXIDE PROTECTANT ZINC OXIDE SPRAY TOPICAL 20141229 OTC MONOGRAPH FINAL part347 Crawford Healthcare, Inc. ZINC OXIDE 25 g/100g 70253-004_743445c9-5266-41a4-976e-d619e128d816 70253-004 HUMAN OTC DRUG Antacid Antigas Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part331 Nash Finch Company ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 20; 200 mg/5mL; mg/5mL; mg/5mL 70253-016_20f0c950-4d46-41e3-be22-e71b6481ad94 70253-016 HUMAN OTC DRUG Our Family Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Nash-Finch Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g 70253-018_7b8bd848-7faf-4ea0-9d18-d8c2b2969a8c 70253-018 HUMAN OTC DRUG Tussin DM Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Nash-Finch Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 70253-018_92b2e66e-4ab3-4228-b612-f4b299809359 70253-018 HUMAN OTC DRUG Tussin DM Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20090603 OTC MONOGRAPH FINAL part341 Nash-Finch Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 70253-019_1f5b0719-4346-4dcf-9748-ba4560bddb9a 70253-019 HUMAN OTC DRUG Heartburn Relief 24 hour Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130327 ANDA ANDA202727 OUR FAMILY (Nash Finch Company) LANSOPRAZOLE 15 mg/1 70253-020_1a26391e-9352-4091-bc82-d6d01afc130c 70253-020 HUMAN OTC DRUG Tussin Original GUAIFENESIN LIQUID ORAL 20090320 OTC MONOGRAPH FINAL part341 Nash-Finch Company GUAIFENESIN 100 mg/5mL 70253-022_db1c765e-4b2e-454c-8b3c-0705db682bb4 70253-022 HUMAN OTC DRUG Our Family Athletes Foot Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Nash Finch Company CLOTRIMAZOLE 10 mg/g 70253-025_34982006-90bc-4065-89fe-25d93e670e93 70253-025 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part341 Nash-Finch Company DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 70253-059_55c7ef73-d31e-46df-9130-3fafdbe4cd9e 70253-059 HUMAN OTC DRUG Our Family Hydrocortisone with Aloe Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Nash-Finch Company HYDROCORTISONE 1 g/100g 70253-069_27080afc-4411-48b0-abaf-88d3c1c2f7e7 70253-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 19900115 OTC MONOGRAPH FINAL part347 Nash Finch Company PETROLATUM 1 g/g 70253-078_0db6f24e-bb4c-4cb7-b480-37a85cad07e2 70253-078 HUMAN OTC DRUG Milk of Magnesia Original Magnesium Hydroxide SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part334 Nash-Finch Company MAGNESIUM HYDROXIDE 1200 mg/15mL 70253-078_6cc30ecd-6567-42f1-9227-21ece59fc322 70253-078 HUMAN OTC DRUG Milk of Magnesia Original Magnesium Hydroxide SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part334 Nash-Finch Company MAGNESIUM HYDROXIDE 1200 mg/15mL 70253-081_1ede8023-c4d1-4633-bc1a-5ebe72fa7a0e 70253-081 HUMAN OTC DRUG Milk of Magnesia Mint MAGNESIUM HYDROXIDE SUSPENSION ORAL 20090320 OTC MONOGRAPH FINAL part334 Nash-Finch Company MAGNESIUM HYDROXIDE 1200 mg/15mL 70253-081_e0e3c759-dd51-466e-ab5d-02878366f1be 70253-081 HUMAN OTC DRUG Milk of Magnesia Mint Magnesium Hydroxide SUSPENSION ORAL 20090320 OTC MONOGRAPH FINAL part334 Nash-Finch Company MAGNESIUM HYDROXIDE 1200 mg/15mL 70253-104_3631bdb8-227d-4fda-8082-8620593865e7 70253-104 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 19900713 OTC MONOGRAPH FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN 325 mg/1 70253-106_8266106e-e387-40b2-8dc0-251a3335b54f 70253-106 HUMAN OTC DRUG Our Family Childrens Cetirizine Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Nash Finch Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL 70253-112_06272f4e-03d2-459a-97e2-c5fa12721be0 70253-112 HUMAN OTC DRUG Night Time Original Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20051108 OTC MONOGRAPH FINAL part341 Nash-Finch Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 70253-112_7247d22c-ce36-49cf-929f-43f34f184244 70253-112 HUMAN OTC DRUG Night Time Original Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20051108 OTC MONOGRAPH FINAL part341 Nash-Finch Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 70253-113_674c2039-adc2-429a-b4bd-8613596bc822 70253-113 HUMAN OTC DRUG Night Time Cherry Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20051108 OTC MONOGRAPH FINAL part341 Nash-Finch Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 70253-113_6f4fa628-0553-4a04-9ebf-954de341dce4 70253-113 HUMAN OTC DRUG Night Time Cherry Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20051108 OTC MONOGRAPH FINAL part341 Nash-Finch Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL 70253-128_5af0651f-ab83-4792-b462-4793f4d0c643 70253-128 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20131015 ANDA ANDA077146 OUR FAMILY (Nash Finch Company) FAMOTIDINE 10 mg/1 70253-129_cfb58d0b-4e30-40d2-b808-cefb41f96af8 70253-129 HUMAN OTC DRUG All Day Allergy Relief 24 Hour Cetirizine HCl TABLET ORAL 20130315 ANDA ANDA078780 OUR FAMILY (NASH FINCH COMPANY) CETIRIZINE HYDROCHLORIDE 10 mg/1 70253-142_90faf656-ee74-4938-846c-c25749f25c07 70253-142 HUMAN OTC DRUG Day Time with PE Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20070102 OTC MONOGRAPH FINAL part341 Nash-Finch Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL 70253-153_b02e567e-1cba-4c16-a1b3-7dba95881bd8 70253-153 HUMAN OTC DRUG Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 19980605 OTC MONOGRAPH FINAL part358 Nash Finch Company PYRITHIONE ZINC 1 kg/100kg 70253-159_7f07976a-5dc0-46f7-acd7-205c3add0958 70253-159 HUMAN OTC DRUG Headache Relief Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 70253-175_54788934-e7f6-4d53-a3f7-3fa6748bdeda 70253-175 HUMAN OTC DRUG Pain Reliever Acetaminophen TABLET ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN 500 mg/1 70253-190_93b75f48-b44c-44e5-8e43-7a0180dc3b1e 70253-190 HUMAN OTC DRUG Allergy Complete Relief Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part336 NASH-FINCH COMPANY DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 70253-199_19a6fe87-33b9-4815-9ca7-98e251dc9b7a 70253-199 HUMAN OTC DRUG Ibuprofen IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20130430 ANDA ANDA078682 OUR FAMILY (Nash Finch Company) IBUPROFEN 200 mg/1 70253-214_c6416a55-c644-4bc7-8202-e6c808ab2581 70253-214 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090821 OTC MONOGRAPH NOT FINAL part356 Nash Finch HYDROGEN PEROXIDE 2.65 mL/100mL 70253-218_e94a4aee-bbc7-4a69-b801-8ec7852f6321 70253-218 HUMAN OTC DRUG Low Dose Chewable Aspirin Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ASPIRIN 81 mg/1 70253-225_e91cc306-fb7b-4d45-9512-3b11cc4bf6b7 70253-225 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH FINAL part338 OUR FAMILY (Nash Finch Company) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 70253-226_1a5df1dd-a6dc-452e-84c3-2d62522bc86b 70253-226 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19921121 OTC MONOGRAPH FINAL part340 NASH-FINCH COMPANY CAFFEINE 200 mg/1 70253-229_fcd5ab97-c87c-4e21-9f0e-1f08c1745670 70253-229 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130331 OTC MONOGRAPH FINAL part338 OUR FAMILY (Nash Finch Company) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 70253-233_d3cbae4f-2314-459f-9039-98c57f266191 70253-233 HUMAN OTC DRUG Mucus Relief Cold, Flu and Sore Throat Maximum Strength Mucinex Fast Max Cold, Flu and Sore Throat Maximum Strength LIQUID ORAL 20131121 OTC MONOGRAPH FINAL part341 Nash Finch ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL 70253-235_ff793ee7-3832-4c86-8552-df73623074c6 70253-235 HUMAN OTC DRUG Pain Reliever PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 70253-236_4e224d76-dbbe-4599-9edf-2f7c1974d22e 70253-236 HUMAN OTC DRUG Nighttime Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 OUR FAMILY (Nash Finch Company) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 70253-242_516e2677-54cf-4699-ba9d-5ad9b74a2230 70253-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH FINAL part347 OUR FAMILY (Nash Finch Company) DIMETHICONE 125 mg/1 70253-250_a8faebd0-6e9d-4022-9148-2cf823547ef4 70253-250 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen LIQUID ORAL 20140319 ANDA ANDA079058 Nash-Finch Company (Our Family) IBUPROFEN 50 mg/1.25mL 70253-255_d467001a-84a0-49ae-8a85-4625f463a803 70253-255 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SOLUTION ORAL 20060718 ANDA ANDA074916 Nash-Finch Company (Our Family) IBUPROFEN 100 mg/5mL 70253-263_262032ec-1bb7-4ce4-8c1a-a019d64b16af 70253-263 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SOLUTION ORAL 20060718 ANDA ANDA074916 Nash-Finch Company (Our Family) IBUPROFEN 100 mg/5mL 70253-291_64bcf03a-c131-4b49-8385-cafd5ab12307 70253-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 NASH-FINCH COMPANY IBUPROFEN 200 mg/1 70253-292_fca52e74-e2f8-4a03-a922-31572f47fc48 70253-292 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, COATED ORAL 19880524 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY IBUPROFEN 200 mg/1 70253-299_6d0853b6-8851-4f83-9c5c-3921265a0d6c 70253-299 HUMAN OTC DRUG Allergy Complete Relief Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20010913 OTC MONOGRAPH FINAL part336 NASH-FINCH COMPANY DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 70253-301_5258de9d-21d6-4beb-a13a-b4589796b18b 70253-301 HUMAN OTC DRUG Magnesium Citrate Magnesium Citrate LIQUID ORAL 20090821 OTC MONOGRAPH NOT FINAL part334 Nash Finch MAGNESIUM CITRATE 2.65 mL/100mL 70253-307_fd1f72ea-07f5-403e-a9a3-5e0dc677c93c 70253-307 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090821 OTC MONOGRAPH FINAL part333 Nash Finch ISOPROPYL ALCOHOL 70 mL/100mL 70253-308_1f561102-8dfa-4d79-950b-2f6d862601e6 70253-308 HUMAN OTC DRUG Wintergreen Isopropyl Alcohol Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20090821 OTC MONOGRAPH FINAL part333 Nash Finch ISOPROPYL ALCOHOL 70 mL/100mL 70253-326_273e35f7-d797-492c-925e-70db6354ce21 70253-326 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20050212 OTC MONOGRAPH NOT FINAL part334 NASH-FINCH COMPANY BISACODYL 5 mg/1 70253-327_45427f80-0aa3-4c73-9b0d-cd165699556e 70253-327 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 NASH-FINCH COMPANY BISACODYL 5 mg/1 70253-329_e8d5d673-e554-46f8-b030-90abee889b37 70253-329 HUMAN OTC DRUG Allergy Complete Relief Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 NASH-FINCH COMPANY DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 70253-348_c5e498dd-b6d2-40d6-9e16-bbcefa47491a 70253-348 HUMAN OTC DRUG Maximum Strength Laxative Sennosides TABLET, COATED ORAL 20030104 OTC MONOGRAPH NOT FINAL part334 NASH-FINCH COMPANY SENNOSIDES 25 mg/1 70253-367_89ea4d54-bc9e-4eff-bc86-ef1fc1310878 70253-367 HUMAN OTC DRUG Rest Simply Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 NASH-FINCH COMPANY DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 70253-375_d38c08ac-730f-4426-b830-4c94e0efc154 70253-375 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl CAPSULE ORAL 20050503 ANDA ANDA076497 NASH-FINCH COMPANY LOPERAMIDE HYDROCHLORIDE 2 mg/1 70253-392_537e1786-fe31-4745-9ab3-c38e13c61643 70253-392 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20020330 ANDA ANDA075139 NASH-FINCH COMPANY IBUPROFEN 200 mg/1 70253-393_953f9b8b-bf7e-4d65-8901-5040312f6b77 70253-393 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, COATED ORAL 20020408 ANDA ANDA075139 NASH-FINCH COMPANY IBUPROFEN 200 mg/1 70253-397_114c3ad9-b4f7-41b2-8f06-1638d5a1392f 70253-397 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 20010904 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ASPIRIN 81 mg/1 70253-403_1619f14c-64ce-403a-816f-2fb4f4a9fe78 70253-403 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 NASH-FINCH COMPANY MECLIZINE HYDROCHLORIDE 25 mg/1 70253-453_70e7ff9b-8768-4887-b983-58adff1424e2 70253-453 HUMAN OTC DRUG Suphedrine PE Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 NASH-FINCH COMPANY PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 70253-455_80d4975b-ffa2-4b5f-ae78-2bf8c97b5180 70253-455 HUMAN OTC DRUG Allergy Multi-Symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20050628 OTC MONOGRAPH FINAL part341 NASH-FINCH COMPANY ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 70253-470_6bda14af-c402-4114-a7af-12e3a917a2a8 70253-470 HUMAN OTC DRUG Day Time Cold/Flu Relief ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED ORAL 20130531 OTC MONOGRAPH FINAL part341 OUR FAMILY (Nash Finch Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 70253-480_218b24df-f440-4ea5-b28c-0952d10cb07e 70253-480 HUMAN OTC DRUG Nite Time Cold/Flu Relief ACETAMINOHPEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20130531 OTC MONOGRAPH FINAL part341 OUR FAMILY (Nash Finch Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 70253-514_02fb621a-6823-4d4f-a2dd-c056c7592536 70253-514 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090821 OTC MONOGRAPH NOT FINAL part356 Nash Finch HYDROGEN PEROXIDE 2.65 mL/100mL 70253-519_c367fa0f-4cfc-4bc3-a903-936c3ab9a571 70253-519 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen CAPSULE, LIQUID FILLED ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN 500 mg/1 70253-527_45dca0b1-e810-4159-8888-06a48a333f05 70253-527 HUMAN OTC DRUG Sinus Congestion and Pain Severe Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, COATED ORAL 20050806 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 70253-531_108a368b-b48a-4d19-acae-5eb11cbd241c 70253-531 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen TABLET ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN 500 mg/1 70253-532_2e33755e-d7d4-4f73-a28a-9a482e21dd48 70253-532 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, FILM COATED ORAL 20051222 OTC MONOGRAPH FINAL part341 NASH-FINCH COMPANY GUAIFENESIN 400 mg/1 70253-533_7ed6f003-878f-4f92-b65d-535e2c4cb171 70253-533 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan HBr and Guiafenesin TABLET, FILM COATED ORAL 20051231 OTC MONOGRAPH FINAL part341 NASH-FINCH COMPANY DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 70253-556_47a10a41-8ce9-4f64-995d-baef6b8d7d2c 70253-556 HUMAN OTC DRUG Extra Strength Pain Reliever PM Acetaminophen, Diphenhydramine HCl CAPSULE ORAL 20071217 OTC MONOGRAPH NOT FINAL part341 NASH-FINCH COMPANY ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 70253-558_8ea4e308-b7ad-4d16-a085-69d6813827fe 70253-558 HUMAN OTC DRUG Sinus Congestion and Pain Daytime Acetaminophen and Phenylephrine HCl CAPSULE ORAL 20080317 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 70253-600_7d449d57-a5f2-4232-a7f0-0a087e382261 70253-600 HUMAN OTC DRUG Enteric Coated Aspirin Aspirin TABLET ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ASPIRIN 81 mg/1 70253-620_7750f19e-db97-4c67-8e1f-94a9beb8fa3c 70253-620 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20130615 ANDA ANDA200536 NASH-FINCH COMPANY RANITIDINE HYDROCHLORIDE 150 mg/1 70253-660_5485a3e0-a141-4981-8557-3aeb10f59d5f 70253-660 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20090821 OTC MONOGRAPH NOT FINAL part334 Nash Finch MINERAL OIL 15 mL/15mL 72036-001_853d77fd-3492-4b02-96f8-4acf3f2e10df 72036-001 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20110301 OTC MONOGRAPH FINAL part355 Harris Teeter SODIUM FLUORIDE 1 mg/mL 72036-004_0f3922e5-a951-4030-806a-6bd45d5b8ddc 72036-004 HUMAN OTC DRUG Antacid Antigas Mylanta SUSPENSION ORAL 20100122 OTC MONOGRAPH FINAL part331 Harris Teeter ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE 200; 200; 200 mg/5mL; mg/5mL; mg/5mL 72036-025_f4faaa12-e847-4b4d-811d-0cde9024a1a9 72036-025 HUMAN OTC DRUG Childrens Allergy Benadryl LIQUID ORAL 20100119 OTC MONOGRAPH FINAL part341 Harris Teeter DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 72036-055_2a21a223-dc90-42e9-baf9-cb1f42bfd847 72036-055 HUMAN OTC DRUG yourhome fresh scent Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Harris Teeter BENZALKONIUM CHLORIDE .115 g/1 72036-069_6c69f311-c66b-4694-b2ee-ca828f3058ac 72036-069 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20090209 OTC MONOGRAPH FINAL part347 Harris Teeter PETROLATUM 1 g/g 72036-153_f1418245-a528-4ca5-b8e2-6a8b53caf1e8 72036-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Harris Teeter PYRITHIONE ZINC 1 kg/100L 72036-163_6401cd2f-5966-414f-b4c7-f1dc5f224b39 72036-163 HUMAN OTC DRUG ANTIBACTERIAL FOAMING PEAR SCENT TRICLOSAN SOAP TOPICAL 20101115 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER TRICLOSAN .46 mL/100mL 72036-168_344ffb50-e024-4fcc-877a-7aedcd6ecc91 72036-168 HUMAN OTC DRUG Harris Teeter Foaming TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Harris Teeter TRICLOSAN .6 mL/100mL 72036-168_5975f954-f4cc-45a1-8d51-339b583dbdb3 72036-168 HUMAN OTC DRUG Harris Teeter Foaming TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Harris Teeter TRICLOSAN .6 mL/100mL 72036-177_78639d39-dee1-4bc8-9610-f74a1d2ea7e5 72036-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110322 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER TRICLOSAN .46 mL/100mL 72036-220_1bd6a5c9-612b-4072-b8a2-9c5a1fc5afeb 72036-220 HUMAN OTC DRUG Harris Teeter Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER TRICLOSAN .15 mL/100mL 72036-220_1cf9ad82-fc49-4c08-b777-45ac2792aa3d 72036-220 HUMAN OTC DRUG Harris Teeter Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER TRICLOSAN .15 mL/100mL 72036-220_ca72f631-774d-46db-a6fc-375aa549f321 72036-220 HUMAN OTC DRUG Harris Teeter Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER TRICLOSAN .15 mL/100mL 72036-223_687c4a1e-0aef-494f-8019-24c4040ed147 72036-223 HUMAN OTC DRUG Harris Teeter Hand Sanitizer With Vitamin E and Aloe Alcohol GEL TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Harris Teeter ALCOHOL 62 mL/100mL 72036-223_6e1b868b-4d3d-44cd-9033-e9d872a81815 72036-223 HUMAN OTC DRUG Harris Teeter Hand Sanitizer With Vitamin E and Aloe Alcohol GEL TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Harris Teeter ALCOHOL 62 mL/100mL 72036-227_109051a4-c6b2-49b3-a5c2-489506e2aa7b 72036-227 HUMAN OTC DRUG Harris Teeter Hand Sanitizer With Vitamin E Alcohol GEL TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Harris Teeter ALCOHOL 62 mL/100mL 72036-227_5b1cc4bd-c951-4d6a-a890-a2b45dac5610 72036-227 HUMAN OTC DRUG HARRIS TEETER HAND SANITIZER WITH VITAMIN E ALCOHOL GEL TOPICAL 20110126 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER ALCOHOL 62 mL/100mL 72036-227_f3830943-bcea-4ddb-b5bd-fe989800cb3d 72036-227 HUMAN OTC DRUG Harris Teeter Hand Sanitizer With Vitamin E Alcohol GEL TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Harris Teeter ALCOHOL 62 mL/100mL 72036-230_7fa5e510-38ef-4062-901d-c0a36d65bc2e 72036-230 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20111025 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER ALCOHOL 62 mL/100mL 72036-240_5b1e92d6-be03-4c12-a958-e6fa010b544d 72036-240 HUMAN OTC DRUG FOAMING HAND SANITIZER WITH ALOE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20101116 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER BENZALKONIUM CHLORIDE .1 mL/100mL 72036-294_e9480321-a0ab-4422-aa30-b7edf95ea224 72036-294 HUMAN OTC DRUG HARRIS TEETER ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120802 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER TRICLOSAN .15 mg/100mL 72036-311_0e48b4e2-6958-496e-bc86-9291fd37e859 72036-311 HUMAN OTC DRUG Dandruff Dandruff LOTION/SHAMPOO TOPICAL 20040518 OTC MONOGRAPH FINAL part358H Harris Teeter PYRITHIONE ZINC 1 kg/100kg 72036-370_9c7d7160-0a1f-48dd-bd32-7971258c048c 72036-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20140717 OTC MONOGRAPH NOT FINAL part333A Harris Teeter, LLC ALCOHOL 70 mL/100mL 72036-439_daf0f192-c716-4b3a-a859-1478f108dcd7 72036-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140718 OTC MONOGRAPH NOT FINAL part333A Harris Teeter ALCOHOL 700 mg/mL 72036-720_663da610-5cd4-41aa-924b-658b1b171ae7 72036-720 HUMAN OTC DRUG Harris Teeter Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Harris Teeter TRICLOSAN .115 mL/100mL 75826-104_57a0d269-57f4-4305-bc9f-b578f8762cf5 75826-104 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20110825 OTC MONOGRAPH FINAL part343 Winder Laboratories, LLC ASPIRIN 325 mg/1 75830-001_f14d2229-6671-4f15-aeb8-ace34ea3a0ea 75830-001 HUMAN OTC DRUG Super Viragon Bryonia Alba, Pulsatilla LIQUID ORAL 20110701 20160101 UNAPPROVED HOMEOPATHIC Baseline Nutritionals Inc. BRYONIA ALBA ROOT; PULSATILLA VULGARIS 30; 30 [hp_X]/59mL; [hp_X]/59mL 75830-002_8add58f8-4e01-4e29-921d-7d79ef73d0e7 75830-002 HUMAN OTC DRUG KGP Flush Berberis Vulgaris, Nux Vomica LIQUID ORAL 20111101 UNAPPROVED HOMEOPATHIC Baseline Nutritionals Inc. BERBERIS VULGARIS ROOT BARK; STRYCHNOS NUX-VOMICA SEED 6; 6 [hp_X]/118mL; [hp_X]/118mL 75831-7732_1fbf1947-3e30-430e-9dd9-f41f35026597 75831-7732 HUMAN OTC DRUG DoctorRelief Menthol, Methyl Salicylate GEL TOPICAL 20091204 OTC MONOGRAPH FINAL part348 KPC Products Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 23; 75; 38 mg/g; mg/g; mg/g 75834-040_908b202b-0135-41cd-97c1-dc6bd39f7204 75834-040 HUMAN OTC DRUG Nivanex DMX GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20141124 OTC MONOGRAPH FINAL part341 Nivagen Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 380; 10 mg/1; mg/1; mg/1 75834-060_a3ec1e40-ffc2-4180-8c31-c3f398c1b849 75834-060 HUMAN OTC DRUG Niva-Hist DM BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20141124 OTC MONOGRAPH FINAL part341 Nivagen Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 15; 7.5 mg/5mL; mg/5mL; mg/5mL 75834-500_d01b63e6-70e5-4679-b377-1e0fb78a87b5 75834-500 HUMAN PRESCRIPTION DRUG Metformin hydrochloride ER Metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20131101 ANDA ANDA201991 Nivagen Pharmaceuticals Inc METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 75835-268_a93ff5c0-6e31-4523-9621-dce1b098cfa5 75835-268 HUMAN OTC DRUG Own Breakout Control Fast Acne Remover Salicylic Acid CREAM TOPICAL 20100924 OTC MONOGRAPH FINAL part333D Own Products Inc. SALICYLIC ACID 20 mg/mL 75835-269_dbe69168-0d3e-4d16-9efc-481b5a84cb1b 75835-269 HUMAN OTC DRUG Own Breakout Control Purifying Face Wash Salicylic Acid SOLUTION TOPICAL 20100924 OTC MONOGRAPH FINAL part333D Own Products Inc. SALICYLIC ACID 10 mg/mL 75835-270_b7775770-3349-4952-9fff-59214fea4f17 75835-270 HUMAN OTC DRUG Own Breakout Control Shineless Face Salicylic Acid LOTION TOPICAL 20100924 OTC MONOGRAPH FINAL part333D Own Products Inc. SALICYLIC ACID 10 mg/mL 75840-111_72b163e6-9f58-44a0-bc51-a804036b7da1 75840-111 HUMAN PRESCRIPTION DRUG METHOTREXATE SODIUM METHOTREXATE SODIUM TABLET ORAL 20121001 NDA NDA008085 GenPak Solutions LLC METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] 75847-1001_5c6847fd-3b32-40e6-abb5-f1f3e11d89ac 75847-1001 HUMAN OTC DRUG IASO A5 Super Brightening Formula adenosine CREAM TOPICAL 20101221 UNAPPROVED DRUG OTHER IASO Inc ADENOSINE .0004 mL/mL 75847-1101_bd15c5eb-39c0-4979-b7e6-d7dd9ab9ffb3 75847-1101 HUMAN OTC DRUG IASO Triple Protection BB SPF 30 PA adenosine CREAM TOPICAL 20110109 UNAPPROVED DRUG OTHER IASO Inc ADENOSINE .0004 g/g 75847-1201_ed11f3a1-8584-4e43-b79d-17dc6429e883 75847-1201 HUMAN OTC DRUG IASO White Science EX arbutin CREAM TOPICAL 20110117 UNAPPROVED DRUG OTHER IASO Inc ARBUTIN .02 g/g 75847-1301_9720729f-47e0-479b-ad55-08c1366e4369 75847-1301 HUMAN OTC DRUG IASO White Science EX Emulsion arbutin CREAM TOPICAL 20110117 UNAPPROVED DRUG OTHER IASO Inc ARBUTIN .02 mL/mL 75847-1401_ed75ab89-aa3c-4c75-bf9e-159a1857846f 75847-1401 HUMAN OTC DRUG IASO White Science EX Serum LEVOMENOL LIQUID TOPICAL 20110205 UNAPPROVED DRUG OTHER IASO Inc LEVOMENOL .02 mL/mL 75847-1501_006b6bec-4fb2-4188-9fd2-8c54db8aa352 75847-1501 HUMAN OTC DRUG IASO White Science EX Toner LEVOMENOL LIQUID TOPICAL 20110201 UNAPPROVED DRUG OTHER IASO Inc LEVOMENOL .02 mL/mL 75847-1601_79edf130-0387-43e8-88cc-37279ce90346 75847-1601 HUMAN OTC DRUG DR. IASO OCTINOXATE CREAM TOPICAL 20120617 UNAPPROVED DRUG OTHER IASO Inc OCTINOXATE 7.5 mL/100mL 75847-1701_6ab320ac-2c9c-4a16-9315-80681ed28a92 75847-1701 HUMAN OTC DRUG IASO FOR MEN WHITE EX AFTER SHAVE SUPREME GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc GLYCERIN .01 g/mL 75847-1702_9edb2caa-4c8f-44f5-b101-4ad20c913198 75847-1702 HUMAN OTC DRUG IASO FOR MEN WHITE EX SUPREME GLYCERIN EMULSION TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc GLYCERIN .034 g/mL 75847-1703_30b297ec-0c15-421f-98cf-2293feb9e526 75847-1703 HUMAN OTC DRUG IASO FOR MEN WHITE EX 2-IN-1 FLUID SUPREME GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc GLYCERIN .0001 g/mL 75847-1704_e2abcffc-1fde-41fe-8b5d-9847fbe5ba35 75847-1704 HUMAN OTC DRUG DR.ISAO VITA WHITE SERUM GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc GLYCERIN .0125 g/mL 75847-1705_71969c3b-0b4f-4c23-9b56-75f1a1a1608e 75847-1705 HUMAN OTC DRUG DR. IASO VITA WHITE GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc GLYCERIN .04 g/mL 75847-1706_f19ab15f-f0e4-4fdb-bd0a-8c096c3e1c60 75847-1706 HUMAN OTC DRUG IASO PROGRESSIVE AGE CARE GLYCERIN EMULSION TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc GLYCERIN .02 g/mL 75847-1707_2056a221-1ca5-47e1-8bb9-e600f5b71d6a 75847-1707 HUMAN OTC DRUG IASO INTENSIVE CLEAR CONDITIONER GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc GLYCERIN .04 g/mL 75847-1708_fae69e61-0191-46cc-a5f9-778caa7b872d 75847-1708 HUMAN OTC DRUG DR. IASO UV TOTAL BASE SPF 46 PA GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc GLYCERIN .05 g/mL 75847-1709_5b2ceff6-9a86-49f2-b625-792877a965c2 75847-1709 HUMAN OTC DRUG IASO SMART POWDER PACT 23 ZINC OXIDE POWDER TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc ZINC OXIDE .0291 g/g 75847-1710_9b23a5b6-e517-4d48-ab01-f4ae9b303fe8 75847-1710 HUMAN OTC DRUG IASO COVER VEIL PACT 25 ZINC OXIDE POWDER TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc ZINC OXIDE .0192 g/g 75847-1711_aa3ab49e-639f-489e-b81f-c5b47d4a550b 75847-1711 HUMAN OTC DRUG DR. IASO POWER 23 ZINC OXIDE POWDER TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc ZINC OXIDE .0192 g/g 75847-1712_b5b5a81c-1281-465a-ae1a-99c765e3a3ee 75847-1712 HUMAN OTC DRUG IASO CONTROL MAKE UP BASE 60 ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc ZINC OXIDE .03 g/mL 75847-2001_c8ed08fe-de32-44c6-a686-eba3fc2e30a0 75847-2001 HUMAN OTC DRUG IASO progressive age care toner adenosine LIQUID TOPICAL 20110101 UNAPPROVED DRUG OTHER IASO Inc ADENOSINE .0004 mL/mL 75847-3001_e72531f1-c2e3-4596-b2c9-e31fd722660e 75847-3001 HUMAN OTC DRUG IASO progressive age care emulsion adenosine CREAM TOPICAL 20110101 UNAPPROVED DRUG OTHER IASO Inc ADENOSINE .0004 mL/mL 75847-4001_c98edb97-8e71-4dd1-b50e-4461b7a1fe06 75847-4001 HUMAN OTC DRUG IASO progressive age care serum adenosine CREAM TOPICAL 20110109 UNAPPROVED DRUG OTHER IASO Inc ADENOSINE .0004 mL/mL 75847-5001_31f2c9fe-815b-42f2-921e-dce31ec19494 75847-5001 HUMAN OTC DRUG IASO progressive age care adenosine CREAM TOPICAL 20110109 UNAPPROVED DRUG OTHER IASO Inc ADENOSINE .0004 g/g 75847-6001_0141eb71-343e-4160-88c3-a4a3f932bb4a 75847-6001 HUMAN OTC DRUG IASO Pregressive Age Care Eye adenosine CREAM TOPICAL 20110109 UNAPPROVED DRUG OTHER IASO Inc ADENOSINE .0004 g/g 75847-7001_e980c0b9-df77-4852-858d-7b6fbe7ffe35 75847-7001 HUMAN OTC DRUG IASO Intensive Clear Booster SALICYLIC ACID LIQUID TOPICAL 20110109 UNAPPROVED DRUG OTHER IASO Inc SALICYLIC ACID .003 mL/mL 75847-8001_3373c99e-1329-41c1-8fc4-2cad5888ed8e 75847-8001 HUMAN OTC DRUG IASO Intensive Clear Conditioner salicylic acid LIQUID TOPICAL 20110109 UNAPPROVED DRUG OTHER IASO Inc SALICYLIC ACID .0001 mL/mL 75847-9001_2a06053b-f263-4dde-ba43-b3726d721eaa 75847-9001 HUMAN OTC DRUG UV Shield SPF 42 OCTINOXATE LIQUID TOPICAL 20110109 UNAPPROVED DRUG OTHER IASO Inc OCTINOXATE .075 mL/mL 75848-0100_b3a725f7-3438-4b76-893b-acd7b724d231 75848-0100 HUMAN OTC DRUG Almond Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Harrison Specialty Co., Inc. ALCOHOL 62 mL/100mL 75848-0200_604648ff-7f35-4067-9443-8575f3e62024 75848-0200 HUMAN OTC DRUG Coconut Lime Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Harrison Specialty Co., Inc. ALCOHOL 62 mL/100mL 75848-0300_c986c640-7029-466b-9434-011cc9dc742e 75848-0300 HUMAN OTC DRUG Egyptian Cotton Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Harrison Specialty Co., Inc. ALCOHOL 62 mL/100mL 75848-0400_666f6221-f84e-4b3a-bb1a-78bdcc7e57d8 75848-0400 HUMAN OTC DRUG Lavender Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Harrison Specialty Co., Inc. ALCOHOL 62 mL/100mL 75848-0500_71ee0d29-bdad-492e-baf6-ca061d3ac3d7 75848-0500 HUMAN OTC DRUG Lavender de Provence Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Harrison Specialty Co., Inc. ALCOHOL 62 mL/100mL 75848-0600_32e3cdc0-1a61-4fd9-ab46-7a3098789010 75848-0600 HUMAN OTC DRUG Lemon Thyme Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Harrison Specialty Co., Inc. ALCOHOL 62 mL/100mL 75848-0700_409da2b5-d468-43b6-86d1-839bb8c67153 75848-0700 HUMAN OTC DRUG Mandarin Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Harrison Specialty Co., Inc. ALCOHOL 62 mL/100mL 75848-0800_2e76ed69-6c43-4db9-a2a0-1a8616c79865 75848-0800 HUMAN OTC DRUG Olive Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Harrison Specialty Co., Inc. ALCOHOL 62 mL/100mL 75848-0900_eb3cc9ef-4407-4552-9499-d166a33ae9ef 75848-0900 HUMAN OTC DRUG Vanilla Bean Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Harrison Specialty Co., Inc. ALCOHOL 62 mL/100mL 75849-100_8e47d845-a8ab-4e13-8b1d-f2b3638ca960 75849-100 HUMAN OTC DRUG Valtrum US Soothing Topical Analgesic CAMPHOR (SYNTHETIC), MENTHOL OINTMENT TOPICAL 20110309 OTC MONOGRAPH FINAL part348 Laboratorios Quantium LLC CAMPHOR (SYNTHETIC); MENTHOL 3; 3 g/100g; g/100g 75849-200_594ad900-912c-422a-98a2-579112e85d29 75849-200 HUMAN OTC DRUG Valtrum US Aerobic Sport IMMEDIATE ACTION CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE LIQUID TOPICAL 20130606 OTC MONOGRAPH NOT FINAL part348 Laboratorios Quantium LLC CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 2.5; 2.5; 10 g/100g; g/100g; g/100g 75854-102_f02f98cd-e3fd-4c8b-9cc3-4fa5508062e2 75854-102 HUMAN PRESCRIPTION DRUG Ana-Lex hydrocortisone acetate and lidocaine hydrochloride CREAM TOPICAL 20080228 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE 20; 20 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 75854-201_30371119-beaf-4ade-a9d5-12adc09f7827 75854-201 HUMAN PRESCRIPTION DRUG DISALCID Salsalate TABLET ORAL 20140918 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC SALSALATE 500 mg/1 75854-202_30371119-beaf-4ade-a9d5-12adc09f7827 75854-202 HUMAN PRESCRIPTION DRUG DISALCID Salsalate TABLET ORAL 20140918 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC SALSALATE 750 mg/1 75854-301_ae24a5b1-0688-4c76-ac39-770bb5377091 75854-301 HUMAN PRESCRIPTION DRUG Prenate Elite .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, zinc oxide and cupric oxide TABLET, COATED ORAL 20120806 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE; ZINC OXIDE 10; 2600; 75; 330; 100; 6; 450; 1.5; 13; 26; 1; 25; 21; 150; 21; 3.5; 3; 15 [iU]/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 75854-302_d4ee6ee8-e5c2-464e-b68c-a6510c32a098 75854-302 HUMAN PRESCRIPTION DRUG PRENATE DHA ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, magnesium oxide and doconexent CAPSULE, GELATIN COATED ORAL 20120131 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC .ALPHA.-TOCOPHEROL, DL-; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE 10; 90; 145; 220; 13; 300; 28; 1; 50; 26 [iU]/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 75854-303_09e2b1e8-94fa-4015-9cc4-9e81b605c6c0 75854-303 HUMAN PRESCRIPTION DRUG prenate essential - ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent TABLET, COATED ORAL 20121112 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC .ALPHA.-TOCOPHEROL, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; ICOSAPENT; MAGNESIUM OXIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE 10; 90; 280; 145; 220; 13; 300; 29; 1; 40; 50; 150; 26 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 75854-304_2f878a07-6f89-4ef2-8f53-26d2768155d1 75854-304 HUMAN PRESCRIPTION DRUG prenate mini ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, iron pentacarbonyl, potassium iodide, magnesium oxide, doconexent and lowbush blueberry CAPSULE, GELATIN COATED ORAL 20120515 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC .ALPHA.-TOCOPHEROL, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FOLIC ACID; IRON PENTACARBONYL; LOWBUSH BLUEBERRY; MAGNESIUM OXIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE 10; 60; 280; 100; 220; 13; 350; 1; 29; 25; 25; 150; 26 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 75854-305_9412fffa-6a5b-4dde-a0f4-07b6d71280a4 75854-305 HUMAN PRESCRIPTION DRUG FeRiva ferrous bisglycinate, ascorbic acid, folic acid, cyanocobalamin, biotin CAPSULE ORAL 20121230 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; FERROUS BISGLYCINATE; FOLIC ACID 175; 300; 120; 75; 1 mg/1; ug/1; ug/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 75854-306_46d0309d-b2c8-40ee-a076-063e513ada52 75854-306 HUMAN PRESCRIPTION DRUG Prenate Chewable calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin and bilberry TABLET, CHEWABLE ORAL 20130116 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC BILBERRY; BIOTIN; BORON; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; MAGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE 25; 280; 250; 500; 300; 125; 1; 50; 10 mg/1; ug/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 75854-307_961e9823-88be-44fa-9148-b4704aa3b74e 75854-307 HUMAN PRESCRIPTION DRUG Prenate AM .pyridoxine hydrochloride, cyanocobalamin, calcium carbonate and folic acid TABLET, COATED ORAL 20130615 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC CALCIUM CARBONATE; CYANOCOBALAMIN; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE 200; 12; 1; 75 mg/1; ug/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 75854-308_1076ba9a-0168-492f-ba9b-99fa02186092 75854-308 HUMAN PRESCRIPTION DRUG PRENATE Restore ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent CAPSULE, GELATIN COATED ORAL 20130917 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; LACTIC ACID; MAGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE 10; 85; 500; 155; 1000; 12; 400; 27; 1; 10; 45; 25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 75854-309_cf10de09-6ed5-4a66-84fa-2da4f668bbe6 75854-309 HUMAN PRESCRIPTION DRUG PRENATE Enhance ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent CAPSULE, GELATIN COATED ORAL 20130917 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM OXIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE 10; 85; 500; 155; 1000; 12; 400; 28; 1; 50; 150; 25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 75854-310_ca59cff2-82ec-4959-94d0-c46b13db5aca 75854-310 HUMAN PRESCRIPTION DRUG FeRivaFA ferrous bisglycinate, ascorbic acid, folic acid, cyanocobalamin, biotin, cupric oxide and docusate sodium CAPSULE, GELATIN COATED ORAL 20140102 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC ASCORBIC ACID; BIOTIN; CUPRIC OXIDE; CYANOCOBALAMIN; DOCUSATE SODIUM; FERROUS BISGLYCINATE; FOLIC ACID 175; 300; 1; 12; 50; 110; 1 mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 75854-311_e853c0be-6cfb-4174-b020-1ea2bc35af1a 75854-311 HUMAN PRESCRIPTION DRUG Prenate Star .beta.-carotene, ascorbic acid, cholecalciferol, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, zinc oxide and cupric oxide TABLET, COATED ORAL 20140605 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC .BETA.-CAROTENE; ASCORBIC ACID; BIOTIN; CALCIUM FORMATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS ASPARTO GLYCINATE; FOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 3300; 75; 330; 155; 6; 450; 1.5; 12; 20; 1; 25; 21; 150; 21; 2; 1.5; 15 [iU]/1; mg/1; ug/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 75854-312_8f2eca71-9a82-4a19-9206-36a04b865fe1 75854-312 HUMAN PRESCRIPTION DRUG PRENATE DHA ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent CAPSULE, GELATIN COATED ORAL 20140605 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC .ALPHA.-TOCOPHEROL, DL-; ASCORBIC ACID; CALCIUM FORMATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS ASPARTO GLYCINATE; FOLIC ACID; MAGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE 40; 90; 155; 400; 25; 300; 18; 1; 50; 26 [iU]/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 75854-313_e5acfb2a-0959-4542-9b4c-790be194d581 75854-313 HUMAN PRESCRIPTION DRUG Prenate Essential ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent CAPSULE, GELATIN COATED ORAL 20140718 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; 5-METHYLTETRAHYDROFOLIC ACID; ASCORBIC ACID; BIOTIN; CALCIUM FORMATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS ASPARTO GLYCINATE; FOLIC ACID; ICOSAPENT; MAGNESIUM OXIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE 10; 600; 90; 280; 155; 220; 13; 300; 18; 400; 40; 50; 150; 26 [iU]/1; ug/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 75854-314_9b79c950-4312-4a53-9e36-fb8e00b053df 75854-314 HUMAN PRESCRIPTION DRUG Prenate Elite .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, calcium formate, ferrous asparto glycinate, cyanocobalamin, biotin, potassium iodide, magnesium oxide, zinc oxide and cupric oxide TABLET, COATED ORAL 20140605 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; 5-METHYLTETRAHYDROFOLIC ACID; ASCORBIC ACID; BIOTIN; CALCIUM FORMATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS ASPARTO GLYCINATE; FOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 40; 2600; 600; 75; 330; 155; 600; 1.5; 13; 20; 400; 25; 21; 150; 21; 3.5; 3; 15 [iU]/1; [iU]/1; ug/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 75854-342_8ac1cdd0-e6b4-4cdf-9448-a7aaf9cba55b 75854-342 HUMAN PRESCRIPTION DRUG Nicomide niacinamide, folic acid, zinc oxide and cupric oxide TABLET ORAL 20120615 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC CUPRIC OXIDE; FOLIC ACID; NIACINAMIDE; ZINC OXIDE 1.5; 500; 750; 25 mg/1; ug/1; mg/1; mg/1 75854-601_ce17984c-e5d8-4966-a606-f8b7f44b14af 75854-601 HUMAN PRESCRIPTION DRUG Falessa Levonorgestrel and Ethinyl Estradiol KIT 20140217 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC 75857-0001_1a8886dc-280d-4247-b4e0-5b29d2298c18 75857-0001 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130814 OTC MONOGRAPH NOT FINAL part333E Ningbo Dowland Daily Health Co., Ltd BENZALKONIUM CHLORIDE .13 g/100g 75857-0003_63df1418-b9cc-45cd-9839-d86ea4e77c76 75857-0003 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130828 OTC MONOGRAPH NOT FINAL part333E Ningbo Dowland Daily Health Co., Ltd BENZALKONIUM CHLORIDE .13 g/100g 75857-1000_e0608e5f-8c0d-4d39-aa4e-13835133ed60 75857-1000 HUMAN OTC DRUG Antibacterial Hand Sanitizer - Citrus Scent ETHYL ALCOHOL GEL TOPICAL 20110127 OTC MONOGRAPH NOT FINAL part333A Ningbo Dowland Daily Health Co., Ltd ALCOHOL 62 g/100g 75857-1001_d112aff3-838b-413b-a2d7-e2a0bb95b5be 75857-1001 HUMAN OTC DRUG Antibacterial Hand Sanitizer Citrus Scent ALCOHOL GEL TOPICAL 20120705 OTC MONOGRAPH FINAL part333E Ningbo Dowland Daily Health Co., Ltd ALCOHOL 62 mL/100mL 75857-1100_1e8ecd20-1870-46ea-adac-bfea3f6b802f 75857-1100 HUMAN OTC DRUG Antibactierial Hand Sanitizer ETHYL ALCOHOL LIQUID ORAL 20130201 OTC MONOGRAPH NOT FINAL part333E Ningbo Dowland Daily Health Co., Ltd ALCOHOL 62 mL/100mL 75857-1101_faf3d060-63e4-416a-8a6d-2cb6367e5cb1 75857-1101 HUMAN OTC DRUG Antibactierial Hand Sanitizer ETHYL ALCOHOL LIQUID ORAL 20130201 OTC MONOGRAPH NOT FINAL part333E Ningbo Dowland Daily Health Co., Ltd ALCOHOL 62 mL/100mL 75857-1102_1cf5902f-a387-4ed1-a40a-9c4da88b171e 75857-1102 HUMAN OTC DRUG Antibactierial Hand Sanitizer ETHYL ALCOHOL LIQUID ORAL 20130201 OTC MONOGRAPH NOT FINAL part333E Ningbo Dowland Daily Health Co., Ltd ALCOHOL 62 mL/100mL 75857-1103_0f2f3fbe-2c29-4a91-a57a-0d8cac7a5560 75857-1103 HUMAN OTC DRUG Antibactierial Hand Sanitizer ETHYL ALCOHOL LIQUID ORAL 20130201 OTC MONOGRAPH NOT FINAL part333E Ningbo Dowland Daily Health Co., Ltd ALCOHOL 62 mL/100mL 75857-1104_6bc93d5d-58d7-4402-b2da-c3f128605335 75857-1104 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20131211 OTC MONOGRAPH NOT FINAL part333E Ningbo Dowland Daily Health Co., Ltd ALCOHOL 62 mL/100mL 75857-1105_c1a4c0b7-5ae2-43e6-8f7e-ef70534f29ef 75857-1105 HUMAN OTC DRUG Antibactierial Hand Sanitizer ETHYL ALCOHOL LIQUID ORAL 20130201 OTC MONOGRAPH NOT FINAL part333E Ningbo Dowland Daily Health Co., Ltd ALCOHOL 62 mL/100mL 75857-1106_edc406c2-0211-48cf-a719-d02597b217af 75857-1106 HUMAN OTC DRUG Antibactierial Hand Sanitizer ETHYL ALCOHOL LIQUID ORAL 20130201 OTC MONOGRAPH NOT FINAL part333E Ningbo Dowland Daily Health Co., Ltd ALCOHOL 62 mL/100mL 75857-1107_5e027b7b-f1cf-4232-aabe-a998a326608c 75857-1107 HUMAN OTC DRUG Antibactierial Hand Sanitizer ETHYL ALCOHOL LIQUID ORAL 20130201 OTC MONOGRAPH NOT FINAL part333E Ningbo Dowland Daily Health Co., Ltd ALCOHOL 62 mL/100mL 75857-1108_f4da6a01-e012-464e-83d7-a4386aa925ac 75857-1108 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20131211 OTC MONOGRAPH NOT FINAL part333E Ningbo Dowland Daily Health Co., Ltd ALCOHOL 62 mL/100mL 75857-1112_97138fe1-5c6a-4fc9-959d-7410ed9631c1 75857-1112 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20131211 OTC MONOGRAPH NOT FINAL part333E Ningbo Dowland Daily Health Co., Ltd ALCOHOL 62 mL/100mL 75857-1123_1cabd0e4-2938-4291-87c2-09725ee7b150 75857-1123 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20131211 OTC MONOGRAPH NOT FINAL part333E Ningbo Dowland Daily Health Co., Ltd ALCOHOL 62 mL/100mL 75857-1147_65e32d99-637c-4638-93d0-0db0425d6592 75857-1147 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20131211 OTC MONOGRAPH NOT FINAL part333E Ningbo Dowland Daily Health Co., Ltd ALCOHOL 62 mL/100mL 75857-1201_48211f76-6815-4119-9773-07a6186bd3d7 75857-1201 HUMAN OTC DRUG Alcohol Free HAND SANITIZER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140623 OTC MONOGRAPH NOT FINAL part333E Ningbo Dowland Daily Health Co., Ltd BENZALKONIUM CHLORIDE 1 mg/mL 75857-1203_b07a6d0c-1b5f-44b0-95f6-08fb79ac0810 75857-1203 HUMAN OTC DRUG Alcohol Free HAND SANITIZER BENZALKONIUM CHLORIDE GEL TOPICAL 20140623 OTC MONOGRAPH NOT FINAL part333E Ningbo Dowland Daily Health Co., Ltd BENZALKONIUM CHLORIDE 1 mg/mL 75857-2150_75d5e4f2-2a9f-45f6-b133-0946acb55e28 75857-2150 HUMAN OTC DRUG SPF 15 Sunscreen OCTINOXATE, OXYBENZONE, OCTISALATE, TITANIUM DIOXIDE LOTION TOPICAL 20130918 OTC MONOGRAPH NOT FINAL part352 Ningbo Dowland Daily Health Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 10; 15; 20 mg/mL; mg/mL; mg/mL; mg/mL 75857-2151_5f52e999-5238-4149-b289-43a8f7a246f6 75857-2151 HUMAN OTC DRUG SPF 15 Sunscreen OCTINOXATE, OXYBENZONE, OCTISALATE, TITANIUM DIOXIDE LOTION TOPICAL 20130918 OTC MONOGRAPH NOT FINAL part352 Ningbo Dowland Daily Health Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 10; 15; 20 mg/mL; mg/mL; mg/mL; mg/mL 75857-2153_e3c29a85-b867-4dc5-a8bf-ecd6f95a57d2 75857-2153 HUMAN OTC DRUG SPF 15 Sunscreen OCTINOXATE, OXYBENZONE, OCTISALATE, TITANIUM DIOXIDE LOTION TOPICAL 20130620 OTC MONOGRAPH NOT FINAL part352 Ningbo Dowland Daily Health Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 10; 15; 20 mg/mL; mg/mL; mg/mL; mg/mL 75857-2155_4edaa77a-06e8-476a-ae3d-e48b92f171a8 75857-2155 HUMAN OTC DRUG SPF 15 Sunscreen OCTINOXATE, OXYBENZONE, OCTISALATE, TITANIUM DIOXIDE LOTION TOPICAL 20130620 OTC MONOGRAPH NOT FINAL part352 Ningbo Dowland Daily Health Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 10; 15; 20 mg/mL; mg/mL; mg/mL; mg/mL 75857-2156_a7ba677d-0e03-4f14-b7ea-7f27fe6e2fa5 75857-2156 HUMAN OTC DRUG SPF 15 Sunscreen OCTINOXATE, OXYBENZONE, OCTISALATE, TITANIUM DIOXIDE LOTION TOPICAL 20130620 OTC MONOGRAPH NOT FINAL part352 Ningbo Dowland Daily Health Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 10; 15; 20 mg/mL; mg/mL; mg/mL; mg/mL 75857-2300_c14909e5-acd8-414f-9f4d-76f49c21a7be 75857-2300 HUMAN OTC DRUG SunscreenSPF 30 SPF 30 Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part352 Ningbo Dowland Daily Health Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 2.5 mg/mL; mg/mL; mg/mL; mg/mL 75857-2301_d08bb047-1a05-4636-a9b2-f7823dcd6488 75857-2301 HUMAN OTC DRUG SunscreenSPF 30 SPF 30 Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part352 Ningbo Dowland Daily Health Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 2.5 mg/mL; mg/mL; mg/mL; mg/mL 75857-2302_718e7e11-6625-4897-834f-b07b9d95050d 75857-2302 HUMAN OTC DRUG SunscreenSPF 30 SPF 30 Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part352 Ningbo Dowland Daily Health Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 2.5 mg/mL; mg/mL; mg/mL; mg/mL 75857-2303_b1d8070b-286d-40ec-8dfe-8227f2eaff7e 75857-2303 HUMAN OTC DRUG SunscreenSPF 30 SPF 30 Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part352 Ningbo Dowland Daily Health Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 2.5 mg/mL; mg/mL; mg/mL; mg/mL 75857-2304_256887ed-1270-4b40-aef7-e20258b1ec3c 75857-2304 HUMAN OTC DRUG Sunscreen SPF 30 Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20130624 OTC MONOGRAPH NOT FINAL part352 Ningbo Dowland Daily Health Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 2.5 mg/mL; mg/mL; mg/mL; mg/mL 75857-2305_e347996a-8d8f-4dd4-955f-bc6bcce7c8df 75857-2305 HUMAN OTC DRUG SunscreenSPF 30 SPF 30 Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part352 Ningbo Dowland Daily Health Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 2.5 mg/mL; mg/mL; mg/mL; mg/mL 75857-2306_a2ad6630-1dd0-4e51-abcc-3974e3b20df2 75857-2306 HUMAN OTC DRUG SunscreenSPF 30 SPF 30 Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part352 Ningbo Dowland Daily Health Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 2.5 mg/mL; mg/mL; mg/mL; mg/mL 75857-3151_e122952a-0881-4d19-ba20-e0f8774ede4e 75857-3151 HUMAN OTC DRUG Lip Balm SPF 15 OCTINOXATE, OXYBENZONE STICK TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Ningbo Dowland Daily Health Co., Ltd OCTINOXATE; OXYBENZONE .075; .03 g/g; g/g 75857-9300_38939e22-fc3d-4c81-9b16-0400a891268c 75857-9300 HUMAN OTC DRUG SPF 30 Sunscreen Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20140108 OTC MONOGRAPH NOT FINAL part352 Ningbo Dowland Daily Health Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 25 mg/mL; mg/mL; mg/mL; mg/mL 75857-9301_fdecae19-ce0b-4942-a83f-fe9c006f345a 75857-9301 HUMAN OTC DRUG SPF 30 Sunscreen Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20140108 OTC MONOGRAPH NOT FINAL part352 Ningbo Dowland Daily Health Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 25 mg/mL; mg/mL; mg/mL; mg/mL 75862-001_f353b745-3138-4002-be33-7349c31d418f 75862-001 HUMAN OTC DRUG HAND SANITIZING GREEN APPLE ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC ALCOHOL 62 mL/100mL 75862-002_90c44300-4eb7-4718-8255-e98ae56ded19 75862-002 HUMAN OTC DRUG HAND SANITIZING MANDARIN ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC ALCOHOL 62 mg/100mL 75862-003_17989b32-ecb8-49a4-a039-043f67ca1bf9 75862-003 HUMAN OTC DRUG HAND SANITIZING BLUEBERRY ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC ALCOHOL 62 mg/100mL 75862-004_14e3e0f4-67ee-416d-b7cc-a4effcc288b4 75862-004 HUMAN OTC DRUG HAND SANITIZING STRAWBERRY ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC ALCOHOL 62 mL/100mL 75862-005_52c97bfd-76fe-42d1-96cb-3d3a3055ed08 75862-005 HUMAN OTC DRUG HAND SANITIZING UNSCENTED ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC ALCOHOL 62 mg/100mL 75862-006_b2aaf77a-6927-4d65-b17d-8f7640bbb911 75862-006 HUMAN OTC DRUG HAND SANITIZING SPECIAL TEACHER GREEN APPLE ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC ALCOHOL 62 mg/100mL 75862-007_5ce9138b-6c0c-49af-8aa5-0893fe4b753c 75862-007 HUMAN OTC DRUG HAND SANITIZING TEACHERS RULE MANDARIN ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC ALCOHOL 62 mg/mL 75862-008_919344a2-c303-4edf-b161-340a0b5f8fcb 75862-008 HUMAN OTC DRUG HAND SANITIZING A PLUS TEACHER UNSCENTED ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC ALCOHOL 62 mg/100mL 75862-009_3ebba235-a0a8-4f0d-bd1a-44529a6229bf 75862-009 HUMAN OTC DRUG BIRDS GARDEN LIP BALM CERULEAN WARBLER SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 GANZ U.S.A., LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 7; 5 g/100g; g/100g; g/100g; g/100g 75862-010_323ed60f-0a71-4cf6-b794-3b43ca8a74e4 75862-010 HUMAN OTC DRUG BIRDS GARDEN LIP BALM WESTERN TANAGER - SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 GANZ U.S.A., LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 7; 5 g/100g; g/100g; g/100g; g/100g 75862-011_dd48e273-44e3-48cd-b59d-ac34723d68e5 75862-011 HUMAN OTC DRUG BIRDS GARDEN LIP BALM DARK EYED JUNCO SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 GANZ U.S.A., LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 7; 5 g/100g; g/100g; g/100g; g/100g 75862-012_c0595792-471f-43c5-985b-8074f12a9c9f 75862-012 HUMAN OTC DRUG Lip Remedy Medicinal Lip Balm BLUE PETROLATUM STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part346 GANZ U.S.A., LLC PETROLATUM 32.3 g/100g 75862-013_c0595792-471f-43c5-985b-8074f12a9c9f 75862-013 HUMAN OTC DRUG Lip Remedy Medicinal Lip Balm GREEN PETROLATUM STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part346 GANZ U.S.A., LLC PETROLATUM 32.3 g/100g 75862-014_c0595792-471f-43c5-985b-8074f12a9c9f 75862-014 HUMAN OTC DRUG Lip Remedy Medicinal Lip Balm RED PETROLATUM STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part346 GANZ U.S.A., LLC PETROLATUM 32.3 g/100g 75862-015_7520e137-ca8e-4dcd-af38-79a2f74a6175 75862-015 HUMAN OTC DRUG Sun-Kissed Lip Balm Lemon Lime SPF30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 GANZ U.S.A., LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 7; 5 g/100g; g/100g; g/100g; g/100g 75862-016_7520e137-ca8e-4dcd-af38-79a2f74a6175 75862-016 HUMAN OTC DRUG Kiss and Shield Lip Balm Lemon Lime SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 GANZ U.S.A., LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 7; 5 g/100g; g/100g; g/100g; g/100g 75862-017_7520e137-ca8e-4dcd-af38-79a2f74a6175 75862-017 HUMAN OTC DRUG Inspired by Color Lemon Lime SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 GANZ U.S.A., LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 7; 5 g/100g; g/100g; g/100g; g/100g 75862-018_8eeb92ef-bf4c-436e-a70c-2538df88cb72 75862-018 HUMAN OTC DRUG FOR THE GARDENER LIP BALM SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 GANZ U.S.A., LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 7; 5 g/100g; g/100g; g/100g; g/100g 75862-019_fb6e2d48-8b3b-4062-b097-9fbea6ce07d5 75862-019 HUMAN OTC DRUG Gourmet Kitchen Regenerating Anti-Bacterial Fresh Picked Fig Benzalkonium Chloride LOTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC BENZALKONIUM CHLORIDE .1 g/100mL 75862-020_f3f77dcc-d5d4-4f76-897e-3d3461ca3758 75862-020 HUMAN OTC DRUG Teacher Collection Anti Bacterial Country Apple Benzalkonium Chloride LOTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC BENZALKONIUM CHLORIDE .1 g/100mL 75862-021_f3f77dcc-d5d4-4f76-897e-3d3461ca3758 75862-021 HUMAN OTC DRUG Teacher Collection Anti Bacterial Sweet Apple Benzalkonium Chloride LOTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC BENZALKONIUM CHLORIDE .1 g/100mL 75862-022_f3f77dcc-d5d4-4f76-897e-3d3461ca3758 75862-022 HUMAN OTC DRUG Teacher Collection Anti Bacterial Delicious Apple Benzalkonium Chloride LOTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC BENZALKONIUM CHLORIDE .1 g/100mL 75862-023_fb6e2d48-8b3b-4062-b097-9fbea6ce07d5 75862-023 HUMAN OTC DRUG Gourmet Kitchen Regenerating Anti-Bacterial Sweet Plum Benzalkonium Chloride LOTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC BENZALKONIUM CHLORIDE .1 g/100mL 75863-1001_9b0f7b93-3696-4db4-b00c-96485c926739 75863-1001 HUMAN OTC DRUG Cheongin Samrakhwan lactic acid PELLET ORAL 20110217 UNAPPROVED DRUG OTHER Entechbio Co., Ltd LACTIC ACID .001 g/g 75863-2001_8bc8211c-e3b9-4815-865d-3719847b1220 75863-2001 HUMAN OTC DRUG Cheongin Haejanghwan lactic acid PELLET ORAL 20110218 UNAPPROVED DRUG OTHER Entechbio Co., Ltd LACTIC ACID .001 g/g 75863-3001_b9ee848e-2150-4024-8d9f-0c48744f8ffb 75863-3001 HUMAN OTC DRUG Cheongin Haewoohwan lactic acid PELLET ORAL 20110218 UNAPPROVED DRUG OTHER Entechbio Co., Ltd LACTIC ACID .001 g/g 75866-001_c8d3457f-68cb-43ce-9a38-0a5bccae280f 75866-001 HUMAN OTC DRUG Antibacterial Hand Cleanser, Non-Alcohol BENZALKONIUM CHLORIDE GEL TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part333E Beacon Promotions BENZALKONIUM CHLORIDE 1 mg/mL 75866-301_1f7524e4-1a47-4f7b-87f2-697ffc1edf8a 75866-301 HUMAN OTC DRUG Bubble Gum Sunscreen Lip Moisturizer OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part352 Beacon Promotions OCTINOXATE; OXYBENZONE 7; 3 g/100g; g/100g 75866-302_7fe3037a-97f1-4c59-bd0b-69a975db8ab3 75866-302 HUMAN OTC DRUG Coconut Sunscreen Lip Moisturizer OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part352 Beacon Promotions, Inc. OCTINOXATE; OXYBENZONE 7; 3 g/100g; g/100g 75866-303_284ce01e-75d3-46b1-a932-a921c7b69d98 75866-303 HUMAN OTC DRUG Cotton Candy Sunscreen Lip Moisturizer OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part352 Beacon Promotions, Inc. OCTINOXATE; OXYBENZONE 7; 3 g/100g; g/100g 75866-304_014af8a3-f126-435e-9b05-83bbdcec8c53 75866-304 HUMAN OTC DRUG Mint Sunscreen Lip Moisturizer OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part352 Beacon Promotions, Inc. OCTINOXATE; OXYBENZONE 7; 3 g/100g; g/100g 75866-305_94cf85f0-6f27-4f43-8912-63b594cbb5d2 75866-305 HUMAN OTC DRUG Pineapple Sunscreen Lip Moisturizer OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part352 Beacon Promotions, Inc. OCTINOXATE; OXYBENZONE 7; 3 g/100g; g/100g 75866-306_6e0e43bf-2b0a-49d6-aef1-4a7db3d07ae4 75866-306 HUMAN OTC DRUG Strawberry Sunscreen Lip Moisturizer OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part352 Beacon Promotions, Inc. OCTINOXATE; OXYBENZONE 7; 3 g/100g; g/100g 75866-307_c2ffc690-8b5b-41d5-8587-47dae254ad9c 75866-307 HUMAN OTC DRUG Vanilla Sunscreen Lip Moisturizer OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part352 Beacon Promotions, Inc. OCTINOXATE; OXYBENZONE 7; 3 g/100g; g/100g 75870-001_213c1e4e-5d9d-4b58-8bdf-f5813719ed4e 75870-001 HUMAN OTC DRUG LIFT THERAPY FORCE LIFT DAY 20 SPF OCTOCRYLENE, COTINOXATE, AVOBENZONE CREAM TOPICAL 20110115 OTC MONOGRAPH NOT FINAL part352 LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.75; 3.75; 5 mL/50mL; mL/50mL; mL/50mL 75870-002_debf540c-ac04-4732-8ea1-9b1f1c2793e4 75870-002 HUMAN OTC DRUG SOFT DERM INTENSIVE DEFENSE 8 SPF OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20070701 OTC MONOGRAPH NOT FINAL part352 LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA OCTINOXATE; TITANIUM DIOXIDE 10; 7.045 mL/50mL; mL/50mL 75870-003_2d837941-c926-4706-b5c1-fe44ab27d103 75870-003 HUMAN OTC DRUG DESPIGMEN PROTECTIVE 25 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20070701 OTC MONOGRAPH NOT FINAL part352 LABORATORIOS DE COSMETICA SCIENTIFICA AT OCTINOXATE; TITANIUM DIOXIDE 3; .88 mL/50mL; mL/50mL 75870-006_c2955e48-40cc-433b-ba15-3228a0c6fdc9 75870-006 HUMAN OTC DRUG SUN PREMIUM FACE 50 SPF OXYBENZONE, OCTINOXATE, AVOBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20070515 OTC MONOGRAPH NOT FINAL part352 LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA AVOBENZONE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 1.5; 3.75; 3.75; 1.185 mL/75mL; mL/75mL; mL/75mL; mL/75mL 75870-007_ec831854-bda7-467b-b309-ed1519b1ea7e 75870-007 HUMAN OTC DRUG Oily SK Specific Solutions SALICYLIC ACID GEL TOPICAL 20080715 OTC MONOGRAPH FINAL part333D LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SALICYLIC ACID .06 mL/15mL 75870-008_dd76ce3c-1349-4357-912c-be7fca98c83d 75870-008 HUMAN OTC DRUG Oily SK Cleansing SALICYLIC ACID GEL TOPICAL 20080715 OTC MONOGRAPH FINAL part333D LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SALICYLIC ACID 1.15 mL/115mL 75870-009_3d1c0612-3dc2-40b1-ac4c-18bbebac7b07 75870-009 HUMAN OTC DRUG Oily SK Balancing I SALICYLIC ACID CREAM TOPICAL 20070715 OTC MONOGRAPH FINAL part333D LABORATORIOS DE COSMETICA SCIENTIFI SALICYLIC ACID .5 mL/50mL 75874-424_6e73b170-b84e-4e37-ac0f-7ba7f60c057f 75874-424 HUMAN PRESCRIPTION DRUG Indocyanine green Indocyanine green INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20111201 ANDA ANDA040811 Novadaq Technologies Inc. INDOCYANINE GREEN 25 mg/1 Diagnostic Dye [EPC],Dyes [MoA] 75874-701_368890cf-c636-473b-9894-9982dcf6d49f 75874-701 HUMAN PRESCRIPTION DRUG IC-Green Indocyanine Green INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130915 NDA NDA011525 Novadaq Technologies Inc. INDOCYANINE GREEN 25 mg/1 75874-820_6e73b170-b84e-4e37-ac0f-7ba7f60c057f 75874-820 HUMAN PRESCRIPTION DRUG Indocyanine green Indocyanine green KIT 19810720 ANDA ANDA040811 Novadaq Technologies Inc. 75878-001_03212fb9-b67c-4098-8a76-8fd8c0d51e51 75878-001 HUMAN OTC DRUG Raggedy Ann and Andy Cotton Candy Triclosan SOAP TOPICAL 20101220 OTC MONOGRAPH NOT FINAL part333E My Habitat Brands LLC TRICLOSAN .002 g/mL 75878-002_8c997368-03bc-4552-bc8d-ea0c2f161141 75878-002 HUMAN OTC DRUG Raggedy Ann and Andy Tropical Breeze Triclosan SOAP TOPICAL 20101220 OTC MONOGRAPH NOT FINAL part333E My Habitat Brands LLC TRICLOSAN .002 g/mL 75878-003_5ea32d43-20f9-4459-80c3-5a5a42d9778f 75878-003 HUMAN OTC DRUG Raggedy Ann and Andy Foam Vanilla Bean Benzalkonium Chloride SOAP TOPICAL 20101220 OTC MONOGRAPH NOT FINAL part333E My Habitat Brands LLC BENZALKONIUM CHLORIDE .0013 g/mL 75878-004_9dde556e-a098-46da-a4b3-d60b3ea6c580 75878-004 HUMAN OTC DRUG Raggedy Ann and Andy Foam Wacky Watermelon Blast Benzalkonium Chloride SOAP TOPICAL 20101220 OTC MONOGRAPH NOT FINAL part333E My Habitat Brands LLC BENZALKONIUM CHLORIDE .0013 g/mL 75884-100_792e8ce2-1d3b-4edd-a6cb-7bd637db02be 75884-100 HUMAN OTC DRUG Halsa Pyrithione Zinc Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20101215 OTC MONOGRAPH FINAL part358H Momentum Brands dba 99 Cents Only Stores PYRITHIONE ZINC 1 mL/100mL 75884-200_497ba136-6387-4746-be75-a296501006a8 75884-200 HUMAN OTC DRUG Halsa Pyrithione Zinc Dandruff - Dry Scalp Care PYRITHIONE ZINC SHAMPOO TOPICAL 20110107 OTC MONOGRAPH FINAL part358H Momentum Brands dba 99 Cents Only Stores PYRITHIONE ZINC 1 mL/100mL 75885-010_cd93b0ad-b8ec-455c-a530-9735905b1d51 75885-010 HUMAN OTC DRUG PUTTO ATO SECRET UV FACE SPF 6 ZINC OXIDE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 AGABANG & COMPANY TITANIUM DIOXIDE; ZINC OXIDE 1.34; 2.7 mL/80mL; mL/80mL 75885-020_2a90f358-5079-4c62-ba83-42712f2bc1b5 75885-020 HUMAN OTC DRUG Putto Secret Sun Screen TITANIUM DIOXIDE CREAM TOPICAL 20130713 OTC MONOGRAPH FINAL part352 AGABANG & COMPANY TITANIUM DIOXIDE 6 mg/100mL 75885-030_cef50561-35f6-4582-a872-2a9fb67b5a29 75885-030 HUMAN OTC DRUG Putto Secret UV Face TITANIUM DIOXIDE CREAM TOPICAL 20130826 OTC MONOGRAPH FINAL part352 AGABANG & COMPANY TITANIUM DIOXIDE 2.6 mg/100mL 75885-040_08b6098d-d9e0-4a06-ad4d-f312635ca155 75885-040 HUMAN OTC DRUG Putto Secret UV Face TITANIUM DIOXIDE CREAM TOPICAL 20130903 OTC MONOGRAPH FINAL part352 AGABANG & COMPANY TITANIUM DIOXIDE 2.96 mg/100mL 75887-001_c434da1f-1978-4fb1-a3c2-6cfc97ceb191 75887-001 HUMAN OTC DRUG Hand Sanitizer Anticeptic ALCOHOL GEL TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part333A Aztex Enterprises ALCOHOL 5 mL/8mL 75887-002_b04a8c62-4b69-43d1-8429-1531c35076df 75887-002 HUMAN OTC DRUG Lip Balm Unflavored Octinoxate, Octisalate, Oxybenzone STICK TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part352 Aztex Enterprises OCTINOXATE; OCTISALATE; OXYBENZONE .3; .08; .13 g/4.2g; g/4.2g; g/4.2g 75887-003_1a05b791-a0ae-48b3-a951-b6928d0bfa44 75887-003 HUMAN OTC DRUG Sunscreen 30 SPF OCTINOXATE, OXYBENZONE LOTION TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part352 Aztex Enterprises OCTINOXATE; OXYBENZONE 22; 16 mL/30mL; mL/30mL 75892-001_34838ce0-e96d-495c-a0e3-2204b230ebd9 75892-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20101222 UNAPPROVED MEDICAL GAS Ohio Valley Acquisition Corp dba Ohio Valley Medical Gas & Supply, Inc. OXYGEN 99 L/100L 75902-1001_a07e92c3-0b69-4290-bac0-61651c32ac86 75902-1001 HUMAN OTC DRUG Whitening Foaming Sodium fluoride MOUTHWASH DENTAL 20101217 UNAPPROVED DRUG OTHER Dio Corporation ALLANTOIN; SODIUM FLUORIDE .0005; .001 mL/mL; mL/mL 75902-2001_96986790-e17a-494c-8008-e60e0702d743 75902-2001 HUMAN OTC DRUG Whitening Foaming-Toothpaste Sodium fluoride GEL, DENTIFRICE DENTAL 20111004 UNAPPROVED DRUG OTHER Dio Corporation ALLANTOIN; SODIUM FLUORIDE .0005; .001 mL/mL; mL/mL 75902-3001_b8bb3cb2-4a74-48a6-84a2-26dc9fcb0a2a 75902-3001 HUMAN OTC DRUG DIO PORORO KIDS FOAMING Sodium fluoride PASTE, DENTIFRICE DENTAL 20141104 UNAPPROVED DRUG OTHER Dio Corporation ALLANTOIN; SODIUM FLUORIDE .05; .1 g/100mL; g/100mL 75904-3246_5ba9ed70-fdbd-435c-ae6f-b6f14e573bca 75904-3246 HUMAN OTC DRUG CalmaFX Moisture Barrier MENTHOL, CALAMINE, ZINC OXIDE OINTMENT TOPICAL 20110228 OTC MONOGRAPH FINAL part347 First Choice Medical Supply FERRIC OXIDE RED; MENTHOL; ZINC OXIDE 20; 4.5; 180 mg/g; mg/g; mg/g 75904-3343_7ea32c8e-f745-4325-a0c2-a891f0f7f55f 75904-3343 HUMAN OTC DRUG PrimaGuard Daily Care Skin Protectant LANOLIN OINTMENT TOPICAL 20110228 OTC MONOGRAPH FINAL part347 First Choice Medical Supply LANOLIN 300 mg/g 75908-017_158c8d15-57e2-48e0-9263-f22ab1671533 75908-017 HUMAN OTC DRUG Periogel hydrogen peroxide GEL DENTAL 20110401 OTC MONOGRAPH NOT FINAL part356 QNT Anderson, LLC HYDROGEN PEROXIDE 17 mg/g 75909-100_0b3e35f8-4276-4149-9c7b-f9f8c7e1c3d7 75909-100 HUMAN OTC DRUG REOROM MULTI DEFENSE DAILY SUN BLOCK TITANIUM DIOXIDE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 HANBUL COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.22; .65 mL/60mL; mL/60mL 75909-110_7ebe43c4-6a04-438d-aa64-d00301c6af85 75909-110 HUMAN OTC DRUG ICS PLATINUM MULTI FINISH BB SPF 47 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 HANBUL COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.69; .67 mL/35mL; mL/35mL 75909-120_539cd2d5-3f08-4718-8aa7-9644a3fdfbe5 75909-120 HUMAN OTC DRUG ICS PERFECT SOLUTION ANTI WRINKLE EYE DIMETHICONE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 HANBUL COSMETICS CO., LTD. DIMETHICONE 1.39 mL/30mL 75909-130_be126176-28d1-47f3-8d5b-b964634671de 75909-130 HUMAN OTC DRUG ICS PERFECT FINISH BB EX SPF 17 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 HANBUL COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.86; .49 mL/50mL; mL/50mL 75909-140_b8bad5d0-c1b8-439f-9825-8ab6f4dd746b 75909-140 HUMAN OTC DRUG LUICHEL SHINY CAKE NO 21 GOLD GIFT SET TITANIUM DIOXIDE POWDER CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 HANBUL COSMETICS CO., LTD. TITANIUM DIOXIDE .92 g/13g 75909-150_dd9534d2-2770-4a16-8e49-a4d002df8756 75909-150 HUMAN OTC DRUG LUICHEL SHINY CAKE NO 23 GOLD GIFT SET TITANIUM DIOXIDE POWDER CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 HANBUL COSMETICS CO., LTD. TITANIUM DIOXIDE .92 g/13g 75909-160_184f98bf-437d-44db-961f-a67db8c2aed9 75909-160 HUMAN OTC DRUG LUICHEL SHINY CAKE NO 33 GOLD GIFT SET TITANIUM DIOXIDE POWDER CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 HANBUL COSMETICS CO., LTD. TITANIUM DIOXIDE .92 g/13g 75913-113_c0a2f539-8c7d-4570-8a92-b4b413e3f101 75913-113 HUMAN PRESCRIPTION DRUG Ammonia N 13 NH3N13 INJECTION INTRAVENOUS 20120320 ANDA ANDA204506 Washington University School of Medicine AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 75913-647_e39657a5-93f1-40b7-b5b3-a9cdfedafc93 75913-647 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F 18 INJECTION INTRAVENOUS 20110102 ANDA ANDA203935 Washington University School of Medicine FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 75916-0634_3a0493c9-c58d-4d92-9345-e0bc231b3763 75916-0634 HUMAN OTC DRUG SnowSkin Sunscreen Zinc OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20110127 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 2.35; 4.2 g/100g; g/100g; g/100g 75916-0635_0c1ac175-0b54-45de-822a-f1d803f53289 75916-0635 HUMAN OTC DRUG GolfersSkin Sunscreen Zinc OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20110127 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 2.35; 4.2 g/100g; g/100g; g/100g 75916-0636_94f4872f-0945-4c31-b37a-b786bffbbc94 75916-0636 HUMAN OTC DRUG SurfersSkin Sunscreen Zinc OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20110127 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 2.35; 4.2 g/100g; g/100g; g/100g 75916-0641_526a2a52-0b3b-4664-816e-537b0783946c 75916-0641 HUMAN OTC DRUG SnowSkin Face Sunscreen OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20110117 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 6; 3.3; 14.25 g/100g; g/100g; g/100g 75916-0659_4921d750-f94a-4603-9f5d-15c32b0fe3ef 75916-0659 HUMAN OTC DRUG Snow Skin Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTOCRYLENE STICK TOPICAL 20110117 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 2.5; 7.5; 5 g/100g; g/100g; g/100g 75916-0660_6d887782-a098-40f7-b9b0-419be858a36a 75916-0660 HUMAN OTC DRUG Surfers Skin Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTOCRYLENE STICK TOPICAL 20110117 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 2.5; 7.5; 5 g/100g; g/100g; g/100g 75916-0664_6fa34154-3763-4ee4-89c0-49bea4fd9b7e 75916-0664 HUMAN OTC DRUG GolfersSkin Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTOCRYLENE STICK TOPICAL 20110119 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 2.5; 7.5; 5 g/100g; g/100g; g/100g 75916-3024_1038067f-2930-480b-9f46-a2a528261727 75916-3024 HUMAN OTC DRUG GolfersSkin Face Sunscreen OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20110127 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 6; 3.3; 14.25 g/100g; g/100g; g/100g 75916-3025_238f55ee-7fb7-4121-8260-1d515709712c 75916-3025 HUMAN OTC DRUG SurfersSkin Face Sunscreen OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20110127 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 6; 3.3; 14.25 g/100g; g/100g; g/100g 75916-4018_27823bb3-6e22-4736-916c-f5fe060cc499 75916-4018 HUMAN OTC DRUG SnowSkin Sunscreen OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110105 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 3.45; 1; 1.95 mL/100mL; mL/100mL; mL/100mL; mL/100mL 75916-4019_1bcab3f2-a9fd-4f3a-8f34-528b3223b54c 75916-4019 HUMAN OTC DRUG Surfers Skin Sunscreen OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 3.45; 1; 1.95 mL/100mL; mL/100mL; mL/100mL; mL/100mL 75916-4020_2a94667f-ffcd-4282-a74e-2b675d019b31 75916-4020 HUMAN OTC DRUG Golfers Skin Broad Spectrum SPF 30 Plus Sunscreen OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 75; 34.5; 10; 19.5 mg/mL; mg/mL; mg/mL; mg/mL 75920-0464_9d3ef929-ec3b-8c82-adca-95593885e99c 75920-0464 HUMAN OTC DRUG Blowfish Aspirin, Caffeine TABLET, EFFERVESCENT ORAL 20110723 OTC MONOGRAPH NOT FINAL part343 Rally Labs LLC ASPIRIN; CAFFEINE 500; 60 mg/1; mg/1 75921-011_2a7c7458-c134-448b-82c6-011889f2f1f3 75921-011 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120118 ANDA ANDA040787 Life Line Home Care Services, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 75921-025_19a1ef21-8020-4246-a46c-e0549260f691 75921-025 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20080331 ANDA ANDA040876 Life Line Home Care Services, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV 75921-045_ace35603-63a6-41dc-9dca-a4c05776d2fa 75921-045 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 Life Line Home Care Services, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII 75921-119_3306f31a-bdf7-4ae3-a6e0-b8692b54cfb6 75921-119 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20120208 ANDA ANDA062676 Life Line Home Care Services, Inc. DOXYCYCLINE HYCLATE 100 mg/1 75921-121_7b333259-a3e0-4997-9c5b-cf3c7ccf2219 75921-121 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride TABLET ORAL 20100604 ANDA ANDA040659 Life Line Home Care Services, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 75921-125_f55a66b0-c052-46e2-ab65-89a43f304aa5 75921-125 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060807 ANDA ANDA077927 Life Line Home Care Services, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 75921-130_8f681b23-29c3-4b42-98e2-71306ca9716d 75921-130 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20120208 ANDA ANDA090510 Life Line Home Care Services, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 75921-133_c9134869-a1de-44e6-9843-f9d1c576846c 75921-133 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE CAPSULE ORAL 20120112 ANDA ANDA040587 Life Line Home Care Services, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] 75921-158_afb09fe8-8038-49ff-b492-d5780171df80 75921-158 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20120229 ANDA ANDA075576 Life Line Home Care Services, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 75921-190_a6a104e3-e634-4f9d-bdfb-33b429b8de1b 75921-190 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Life Line Home Care Services, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 75921-200_d0676c30-33fe-46f3-995b-9116c6cc106a 75921-200 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Life Line Home Care Services, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 75921-208_396aa302-3785-46a0-8369-256f458ebcd3 75921-208 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, COATED ORAL 20100524 ANDA ANDA077478 Life Line Home Care Services, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] 75921-241_11adb6a6-f550-4c38-96c4-4092bc84d956 75921-241 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 Life Line Home Care Services, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 75921-397_7a705103-c019-47c8-b0b3-014fade00636 75921-397 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET ORAL 20020130 ANDA ANDA075967 Life Line Home Care Services, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 75921-402_b95a1e89-9d39-4267-af6f-3a8642043685 75921-402 HUMAN OTC DRUG Cetirizine Cetirizine Hydrochloride TABLET ORAL 20120203 ANDA ANDA077829 Life Line Home Care Services, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 75921-409_355eb776-d27a-400f-a07c-073f581c69ee 75921-409 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Life Line Home Care Services, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 75921-412_17081ef1-c58a-47fc-9683-d9b6776234f8 75921-412 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20120206 ANDA ANDA076639 Life Line Home Care Services, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 75921-438_c6ca168c-85f1-4654-9f6e-2f82f44ee87e 75921-438 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20060718 ANDA ANDA040622 Life Line Home Care Services, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 75921-459_0e655e4b-acb1-4326-8204-44c406a0c4eb 75921-459 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Life Line Home Care Services, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 75921-466_52cab568-ce9d-4005-bcb0-b30bb539787e 75921-466 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20120213 ANDA ANDA078558 Life Line Home Care Services, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 75921-469_eb620096-d9a7-47da-8b98-3568e35a3169 75921-469 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Life Line Home Care Services, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 75921-490_547fccd0-546e-4e62-812d-9585ae02721f 75921-490 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Life Line Home Care Services SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 75921-513_9ab6e359-74b7-4fb3-ac1c-4d59de089604 75921-513 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 19871101 ANDA ANDA087499 Life Line Home Care Services, Inc CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV 75921-515_dc47be05-6e52-4233-90c4-a987cfcaaf8a 75921-515 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100812 ANDA ANDA077321 Life Line Home Care Services, Inc. LISINOPRIL 20 mg/1 75921-578_71f91916-f638-4af0-8c6d-d0fc0a79b83f 75921-578 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20070125 ANDA ANDA078060 Life Line Home Care Services, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 75921-627_d8c3b83b-3f99-41ed-83b4-3d20b19612dd 75921-627 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20110101 ANDA ANDA076003 Life Line Home Care Services, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 75921-648_79f46038-1a1b-4150-8c2f-c0aa160c9846 75921-648 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20120116 ANDA ANDA076001 Life Line Home Care Services, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 75921-795_1e266e28-ad46-45dd-9b2a-91d1edcd8b52 75921-795 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 20120207 ANDA ANDA085223 Life Line Home Care Services, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 75921-881_b653e3b2-984b-49d7-ae0f-7f120f5d9831 75921-881 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19881202 ANDA ANDA089971 Life Line Home Care Services, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 75921-901_7529098f-5707-46ac-b7cd-bc9c24a728d0 75921-901 HUMAN PRESCRIPTION DRUG ALPRAZOLAM Alprazolam TABLET ORAL 20120126 ANDA ANDA074174 Life Line Home Care Services, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 75921-962_56e7edc4-198d-4556-b1e3-28bef7b587cc 75921-962 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20111208 ANDA ANDA065136 Life Line Home Care Services, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 75928-001_a5207872-6e00-42dc-8068-cfc8a2d91e4d 75928-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Nor-Lea Hospital District dba Nor-Lea Home Medical OXYGEN 99 L/100L 75930-001_0f530898-6355-44d0-a05a-a54a247e20cf 75930-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS S & G Home Care dba R & M Transfill OXYGEN 99 L/100L 75932-1001_0ef868bb-d1b3-4e47-b33a-5844616e4150 75932-1001 HUMAN OTC DRUG MORISU HYALURONIC ACID SOLUTION TOPICAL 20110208 UNAPPROVED DRUG OTHER KIT Living Science of Kyungnam College University of Information & Technology HYALURONIC ACID .01 mL/100mL 75933-1425_506650c0-1839-11e0-8305-0002a5d5c51b 75933-1425 HUMAN OTC DRUG Yuma OATMEAL SOAP TOPICAL 20110601 OTC MONOGRAPH FINAL part347 Yuma Outdoors LLC OATMEAL 1.205 g/1 75935-001_a0033ee1-d965-4fec-b23c-b8141741f2a7 75935-001 CELLULAR THERAPY LAVIV azficel-T INJECTION, SUSPENSION INTRADERMAL 20110715 BLA BLA125348 Fibrocell Technologies, Inc. AZFICEL-T 15000000 1/mL Autologous Cultured Cell [EPC],Cells, Cultured, Autologous [Chemical/Ingredient],Fibroblasts [Chemical/Ingredient] 75936-110_c61a9cc4-ed09-4b0f-9b65-3b6e7de3c59b 75936-110 HUMAN OTC DRUG Doctor Ts Super goop Homosalate, Octisalate, Avobenzene, Octocrylene CREAM TOPICAL 20110104 OTC MONOGRAPH FINAL part352 Super Goop AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 8; 4; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 75936-111_972afcb7-3479-4d79-8d06-dc9b69151600 75936-111 HUMAN OTC DRUG City Sunscreen serum SPF 30 Supergoop Homosalate, Octisalate, Avobenzene, Octocrylene CREAM TOPICAL 20101207 OTC MONOGRAPH FINAL part352 Taylor James, Ltd. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 8; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL 75936-112_bd76265e-8f30-42c2-917d-9608dc33ae3d 75936-112 HUMAN OTC DRUG Gradual Self-tanning sunscreen SPF 20 Doctor Ts Supergoop Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20120706 OTC MONOGRAPH NOT FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 5.13; 12.8; 8.6; 4.3 g/171mL; g/171mL; g/171mL; g/171mL 75936-113_97084fad-b993-4b4f-9495-dda5e2adfc8d 75936-113 HUMAN OTC DRUG Mint Fusion Lip Balm SPF 30 Supergoop Octinoxate, Octisalate, Avobenzone CREAM TOPICAL 20120831 OTC MONOGRAPH NOT FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; OCTINOXATE; OCTISALATE .44; 1.11; .74 g/14.79mL; g/14.79mL; g/14.79mL 75936-114_e21c6260-2e2d-403d-b58c-27044217552d 75936-114 HUMAN OTC DRUG Everyday Face and body Broad Spectrum SPF 30 Supergoop Avobenzone, Octinoxate, Octisalate, Octocrylene LOTION TOPICAL 20120622 OTC MONOGRAPH NOT FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 1.32; 3.3; 2.2; 1.232 g/44mL; g/44mL; g/44mL; g/44mL 75936-115_792876b2-435b-4bef-9cac-95696c980bcd 75936-115 HUMAN OTC DRUG Save Face AM Moisturizer Broad Spectrum SPF 35 Supergoop Avobenzone,Octinoxate, Octisalate,Octocrylene LOTION TOPICAL 20120628 OTC MONOGRAPH NOT FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2.7; 6.75; 4.5; 2.51 g/90mL; g/90mL; g/90mL; g/90mL 75936-116_8ca78ea3-3f00-4fa7-95a6-2c5f51c63bbc 75936-116 HUMAN OTC DRUG Sunstick Broad Spectrum SPF 30 Supergoop Octinoxate, Octocrylene, Zinc Oxide CREAM TOPICAL 20120620 OTC MONOGRAPH NOT FINAL part352 TAYLOR JAMES, LTD. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE .38; .23; 1.55 g/7.65mL; g/7.65mL; g/7.65mL 75936-117_3ef96e78-c59b-4262-a704-77ead7977147 75936-117 HUMAN OTC DRUG Sunscreen Day Broad Spectrum SPF 40 Supergoop Octinoxate, Zinc Oxide CREAM TOPICAL 20120626 OTC MONOGRAPH NOT FINAL part352 TAYLOR JAMES, LTD. OCTINOXATE; ZINC OXIDE 2.25; 3.03 g/30mL; g/30mL 75936-118_cc0bb943-1a69-428e-aa2c-1346ee310584 75936-118 HUMAN OTC DRUG Acaifusion Lip Balm Broad Spectrum SPF 30 Supergoop Avobenzone, Octinoxate, Octisalate OINTMENT TOPICAL 20120628 OTC MONOGRAPH NOT FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; OCTINOXATE; OCTISALATE .44; 1.11; .74 g/14.79mL; g/14.79mL; g/14.79mL 75936-119_52088ecc-ac44-448a-ac8a-3c5a6991fcac 75936-119 HUMAN OTC DRUG Sunscreen Day SPF 50 Supergoop Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120630 OTC MONOGRAPH NOT FINAL part352 Taylor James Ltd OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 5.24; 2.13; 2.34; 14.2 g/71mL; g/71mL; g/71mL; g/71mL 75936-120_b9df6f46-2ae0-4426-a3d9-eb4f0a83d846 75936-120 HUMAN OTC DRUG Advanced Anti-Aging Eye Broad Spectrum SPF 37 Supergoop Octinoxate, Zinc Oxide CREAM TOPICAL 20130102 OTC MONOGRAPH NOT FINAL part352 TAYLOR JAMES, LTD. OCTINOXATE; ZINC OXIDE 75; 10.1 mg/mL; mg/mL 75936-121_275d4e9c-b76a-4665-96a1-5ced7e7bbd21 75936-121 HUMAN OTC DRUG CC Daily Correct Broad Spectrum SPF 35 Sunscreen Supergoop Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20130104 OTC MONOGRAPH NOT FINAL part352 TAYLOR JAMES, LTD. TITANIUM DIOXIDE; ZINC OXIDE 20; 200 mg/mL; mg/mL 75936-122_b1428591-04ce-43de-9a57-b5a8fa56f73c 75936-122 HUMAN OTC DRUG CC Daily Correct Broad Spectrum SPF 35 Sunscreen Supergoop Titanium DIoxide, Zinc Oxide CREAM TOPICAL 20130107 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. TITANIUM DIOXIDE; ZINC OXIDE 14.2; 200 mg/mL; mg/mL 75936-123_6db0d03d-c4d2-4e6e-a350-3463db98b5e0 75936-123 HUMAN OTC DRUG Sunscreen Mist Broad Spectrum SPF 30 Supergoop Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene SPRAY TOPICAL 20130107 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 10; 7.5; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 75936-124_d083ff3e-47cc-4bba-9ce2-9132e46a8274 75936-124 HUMAN OTC DRUG Sunscreen Mist Broad Spectrum SPF 50 Supergoop Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene SPRAY TOPICAL 20130129 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 10; 7.5; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 75936-125_1991ad90-280b-48ad-a871-ccec6ceccccb 75936-125 HUMAN OTC DRUG Sun-Defying Sunscreen Oil Broad Spectrum SPF 50 Supergoop Avobenzone, Homosalate, Octisalate, Octocrylene, Octinoxate OIL TOPICAL 20131203 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 15; 7.5; 5; 7 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 75936-126_1a420d48-2112-4b6a-bfe0-2aec2f47373f 75936-126 HUMAN OTC DRUG CC Cream Daily Correct Broad Spectrum SPF 40 Sunscreen Supergooop Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20131204 OTC MONOGRAPH FINAL part352 Taylor James LTD TITANIUM DIOXIDE; ZINC OXIDE 2; 20 g/100mL; g/100mL 75936-128_cf3c135a-2c17-4308-a3ca-6ac706d1c9d9 75936-128 HUMAN OTC DRUG Forever Young Hand Broad Spectrum SPF 40 Supergoop Avobenzone, Homosalate, Octinoxate, Octocrylene CREAM TOPICAL 20140120 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3; 10; 7; 5 g/100mL; g/100mL; g/100mL; g/100mL 75936-129_99e76b0c-3f77-4cc4-8dba-7155f9642f5c 75936-129 HUMAN OTC DRUG Skin Soothing Mineral Sunscreen Broad Spectrum SPF 40 Supergoop Octinoxate, Zinc Oxide CREAM TOPICAL 20140122 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. OCTINOXATE; ZINC OXIDE 7.5; 10.1 g/100mL; g/100mL 75936-130_4135e003-35ef-4b79-8744-a0fdc8f8b6c7 75936-130 HUMAN OTC DRUG Everyday Sunscreen Broad Spectrum SPF 30 Supergoop Homosalate, Octilsalate, Avobenzone, Octocrylene LOTION TOPICAL 20140123 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 8; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL 75936-131_d8e61435-b2c8-4b56-9aeb-db7917b0d4b5 75936-131 HUMAN OTC DRUG Everyday Sunscreen Broad Spectrum SPF 50 Supergoop homosalate, octocrylene, octisalate, Avobenzone CREAM TOPICAL 20140128 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 g/100mL; g/100mL; g/100mL; g/100mL 75939-9876_410a54c1-cdb4-465b-83f6-9986185f2ff1 75939-9876 HUMAN OTC DRUG Liqufruta GUAIFENESIN SYRUP ORAL 20110101 OTC MONOGRAPH FINAL part341 Alston Garrard & Co GUAIFENESIN 50 mg/5mL 75939-9876_ffde5fe1-c84d-4ccf-a417-36ff56b47790 75939-9876 HUMAN OTC DRUG Liqufruta GUAIFENESIN SYRUP ORAL 20110101 OTC MONOGRAPH FINAL part341 Alston Garrard & Co GUAIFENESIN 50 mg/5mL 75940-111_a48d0d1f-9cd4-4170-91ea-c2270ce26e07 75940-111 HUMAN OTC DRUG Pasta de Lassar Andromaco Zinc Oxide CREAM TOPICAL 20140701 OTC MONOGRAPH FINAL part347 MarcasUSA LLC ZINC OXIDE 250 mg/g 75940-121_daf1a114-98d1-4a1a-92de-7a6db9057ca7 75940-121 HUMAN OTC DRUG Conazol Miconazole Nitrate CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part333C MarcasUSA LLC MICONAZOLE NITRATE 20 mg/g 75940-122_529386ad-ddbe-4eb3-a253-00d87f89b8d8 75940-122 HUMAN OTC DRUG CICLOFERON benzalkonium chloride and lidocaine hydrochloride GEL TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333A MarcasUSA LLC BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 20 mg/g; mg/g 75940-127_54c2ead1-8b2d-4024-ab16-ae6bd2644994 75940-127 HUMAN OTC DRUG Conazol Miconazole Nitrate SPRAY TOPICAL 20140625 OTC MONOGRAPH FINAL part333C MarcasUSA LLC MICONAZOLE NITRATE 20 mg/g 75940-131_08949577-e982-49d6-b0fa-2c96191a312c 75940-131 HUMAN OTC DRUG Syncol Acetaminophen, Pamabrom, Pyrilamine Maleate CAPSULE ORAL 20120315 OTC MONOGRAPH NOT FINAL part343 MarcasUSA LLC ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 75942-001_c0e15e03-c564-428a-b6c9-46d114062fd2 75942-001 HUMAN OTC DRUG Adult Low Dose Aspirin Enteric Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 20110118 OTC MONOGRAPH FINAL part343 Zandi LLC ASPIRIN 81 mg/1 75944-100_b1e56151-1121-47fa-9dfa-d59fbb0a6f5f 75944-100 HUMAN OTC DRUG SOL LEON Sunscreen SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20101215 OTC MONOGRAPH FINAL part352 Bottega di Lungavita Srl AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 8; 5; 8 mL/100mL; mL/100mL; mL/100mL; mL/100mL 75944-200_4c218401-e440-4a07-80da-5fbb6041a552 75944-200 HUMAN OTC DRUG SOL LEON Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE CREAM TOPICAL 20101215 OTC MONOGRAPH FINAL part352 Bottega di Lungavita Srl AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 8; 7.5; 5; 8 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 75949-1001_72ca1818-496a-4219-8913-7f9c0272c7d1 75949-1001 HUMAN OTC DRUG Elcure Ato MORUS ALBA ROOT BARK LOTION TOPICAL 20110211 UNAPPROVED DRUG OTHER Elcure Co., Ltd. HYALURONATE SODIUM; JOJOBA OIL; MORUS ALBA ROOT BARK; PLATYCODON GRANDIFLORUM LEAF 65; 5; 10; 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL 75949-2001_69cdb15c-4b82-4df0-bc85-3a2e29ae8549 75949-2001 HUMAN OTC DRUG ELCURE Vitamin C Serum MAGNESIUM ASCORBYL PHOSPHATE LIQUID TOPICAL 20110822 UNAPPROVED DRUG OTHER Elcure Co., Ltd. MAGNESIUM ASCORBYL PHOSPHATE 1.5 mL/50mL 75949-3001_278dba66-83b4-4a48-a31f-b540fc4bb683 75949-3001 HUMAN OTC DRUG ELCURE AOUT Rose adenosine LIQUID TOPICAL 20110822 UNAPPROVED DRUG OTHER Elcure Co., Ltd. ADENOSINE .04 mL/100mL 75949-4001_19b5fe91-a0a3-4b84-9b77-a6721bc7b77e 75949-4001 HUMAN OTC DRUG ELCURE AC-LEX Serum AZELAIC ACID LIQUID TOPICAL 20111124 UNAPPROVED DRUG OTHER Elcure Co., Ltd. AZELAIC ACID 2.5 mL/50mL 75949-5001_2b986c12-4090-45fb-adeb-8d34cc970305 75949-5001 HUMAN OTC DRUG ELCURE C Serum MAGNESIUM ASCORBYL PHOSPHATE LIQUID TOPICAL 20121231 UNAPPROVED DRUG OTHER Elcure Co., Ltd. MAGNESIUM ASCORBYL PHOSPHATE 500 mg/50mL 75949-6001_9457eb1a-a1a1-4a5f-9648-740ad1917122 75949-6001 HUMAN OTC DRUG Elcure Q Serum ADENOSINE LIQUID TOPICAL 20130718 UNAPPROVED DRUG OTHER Elcure Co., Ltd. ADENOSINE 25 mg/50mL 75949-7001_8f9f9335-477e-4274-91e0-95259efb740f 75949-7001 HUMAN OTC DRUG ELCURE CUREKIN CENTELLA ASIATICA SHAMPOO TOPICAL 20130718 UNAPPROVED DRUG OTHER Elcure Co., Ltd. CENTELLA ASIATICA 3000 mg/300mL 75956-145_5023056c-49c6-4e78-819e-1d861d8b8302 75956-145 HUMAN OTC DRUG Male Desensitizer Pleasure Balm Benzocaine GEL TOPICAL 20110214 OTC MONOGRAPH FINAL part348 Kama Sutra BENZOCAINE 3 g/100mL 75956-147_77379b35-c902-451b-b3c7-985ddd809611 75956-147 HUMAN OTC DRUG Pleasure Balm Kama Sutra Benzocaine GEL TOPICAL 20130912 OTC MONOGRAPH FINAL part348 Kama Sutra BENZOCAINE 5 g/100mL 75957-001_8c456365-71e6-47eb-85e1-f4c7bd793fbc 75957-001 HUMAN OTC DRUG Pampers Kandoo Benzalkonium Chloride SOLUTION CUTANEOUS 20110214 OTC MONOGRAPH NOT FINAL part333E Nehemiah Manufacturing BENZALKONIUM CHLORIDE 1.3 mg/mL 75957-002_8c456365-71e6-47eb-85e1-f4c7bd793fbc 75957-002 HUMAN OTC DRUG Pampers Kandoo Benzalkonium Chloride SOLUTION CUTANEOUS 20110214 OTC MONOGRAPH NOT FINAL part333E Nehemiah Manufacturing BENZALKONIUM CHLORIDE 2.6 mg/2mL 75958-1001_97670bb0-6eb8-4079-805c-41f093237c04 75958-1001 HUMAN OTC DRUG Insan Bamboosalt toothpaste CALCIUM CARBONATE PASTE, DENTIFRICE DENTAL 20110213 UNAPPROVED DRUG OTHER Insan Bamboo Salt Inc CALCIUM CARBONATE 31.25 g/100g 75963-125_f413f3df-ff3e-4640-8f84-d13f951ab746 75963-125 HUMAN OTC DRUG Reactice Reactivating Ice Baume Menthol CREAM TOPICAL 20110721 OTC MONOGRAPH NOT FINAL part348 Rejuventus, Inc. MENTHOL 118.29 mL/100mL 75963-126_e164cea7-2085-4617-a595-f90032c53ce3 75963-126 HUMAN OTC DRUG Reactheat Heat Baume Menthol, Capsicum Annum Extract CREAM TOPICAL 20110820 OTC MONOGRAPH FINAL part348 Rejuventus BIRD PEPPER; MENTHOL .5; 5 mL/100mL; mL/100mL 75974-100_64fa5e20-6161-4ce5-9ef8-70b10f6939cc 75974-100 HUMAN OTC DRUG ANC Neverpain External Analgesic MENTHOL SPRAY TOPICAL 20110324 OTC MONOGRAPH NOT FINAL part348 ANC Amazon Natural Corp. MENTHOL 5 mL/100mL 75977-8142_55115d24-691c-426f-95d3-f6aa0d1c217c 75977-8142 HUMAN OTC DRUG Rohto Cool Naphazoline hydrochloride, Polysorbate 80 LIQUID OPHTHALMIC 20120201 OTC MONOGRAPH FINAL part349 Rohto-Mentholatum (Vietnam) Co. Ltd. NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80 .12; 2 mg/mL; mg/mL 75977-8143_c1da5f7a-a1aa-4bdc-aae7-03d3ab82dc50 75977-8143 HUMAN OTC DRUG Rohto Ice hypromellose, tetrahydrozoline HCl, zinc sulfate LIQUID OPHTHALMIC 20110801 OTC MONOGRAPH FINAL part349 Rohto-Mentholatum (Vietnam) Co. Ltd. HYPROMELLOSES; TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE 2; .5; 2.5 mg/mL; mg/mL; mg/mL 75977-8144_12ad07c6-87a6-4d05-98f5-22e7b6330da9 75977-8144 HUMAN OTC DRUG Rohto Arctic Hypromellose, Tetrahydrozoline hydrochloride LIQUID OPHTHALMIC 20120301 OTC MONOGRAPH FINAL part349 Rohto-Mentholatum (Vietnam) Co. Ltd. HYPROMELLOSE 2208 (100 MPA.S); TETRAHYDROZOLINE HYDROCHLORIDE 3.5; .5 mg/mL; mg/mL 75977-8148_1ac9e1f3-9222-4d51-ae7f-0c0c55fc9a2e 75977-8148 HUMAN OTC DRUG Rohto Hydra Hydroxyethyl cellulose LIQUID OPHTHALMIC 20120315 OTC MONOGRAPH FINAL part349 Rohto-Mentholatum (Vietnam) Co. Ltd. HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) 6 mg/mL 75977-8149_aaaee138-ebcb-4e79-bc55-9ea305597cb2 75977-8149 HUMAN OTC DRUG Rohto Relief hypromellose, tetrahydrozoline HCl, zinc sulfate LIQUID OPHTHALMIC 20130601 OTC MONOGRAPH FINAL part349 Rohto-Mentholatum (Vietnam) Co. Ltd. HYPROMELLOSES; TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE 2; .5; 2.5 mg/mL; mg/mL; mg/mL 75978-3048_98fd25cc-3f88-4cb7-9b6a-819058a64e56 75978-3048 HUMAN OTC DRUG Thai Herbal Balm Lemon Grass Menthol and Camphor (synthetic) OINTMENT TOPICAL 20070109 OTC MONOGRAPH NOT FINAL part348 Thai Herb and Spa MENTHOL; METHYL SALICYLATE 5; 6 g/50g; g/50g 75978-3049_a3d2b62f-d104-4e93-8711-d84cc5a5aade 75978-3049 HUMAN OTC DRUG Thai Herbal Balm Lavender Menthol and Camphor (synthetic) OINTMENT TOPICAL 20070109 OTC MONOGRAPH NOT FINAL part348 Thai Herb and Spa CAMPHOR (SYNTHETIC); MENTHOL 1.5; 2.5 g/50g; g/50g 75979-1146_31577dd2-d7ed-4239-a76c-52f1a5190c4c 75979-1146 HUMAN OTC DRUG Imbue Pain Relief menthol - methyl salicylate PATCH TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part356 Imbue Body LLC MENTHOL; METHYL SALICYLATE 51; 15 mg/1; mg/1 75979-1146_a8afe16c-2d30-4ace-a701-78f7a1856fa8 75979-1146 HUMAN OTC DRUG Imbue Pain Relief menthol - methyl salicylate PATCH TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part356 Imbue Body LLC MENTHOL; METHYL SALICYLATE 51; 15 mg/1; mg/1 75981-001_64004b37-45f5-4c5d-a712-929413eff18b 75981-001 HUMAN OTC DRUG GOODSENSE Alcohol ISOPROPYL ALCOHOL LIQUID TOPICAL 20110630 OTC MONOGRAPH NOT FINAL part333A GEISS, DESTIN AND DUNN, INC. ISOPROPYL ALCOHOL 70 g/100g 75981-004_be5e0db6-8ef6-43c8-9416-0af055f0c8ac 75981-004 HUMAN OTC DRUG GOODSENSE ANTIBACTERIAL MOISTURIZING BENZALKONIUM CHLORIDE FILM TOPICAL 20110221 OTC MONOGRAPH NOT FINAL part333A GEISS, DESTIN AND DUNN, INC. BENZALKONIUM CHLORIDE .115 g/1001 75981-007_2cf927a5-aed6-4316-ae4c-71d810f4c6bc 75981-007 HUMAN OTC DRUG GOODSENSE MEDICATED PADS WITCH HAZEL SOLUTION RECTAL; TOPICAL 20110601 OTC MONOGRAPH FINAL part346 GEISS, DESTIN AND DUNN, INC. WITCH HAZEL .5 mL/mL 75981-063_5f09a3f8-b471-4562-9510-95b6ecd6faab 75981-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19920915 OTC MONOGRAPH FINAL part347 Geiss, Destin and Dunn, Inc FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL 75981-069_cde875fa-21cc-4b19-88d5-83d0e6e3ca30 75981-069 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 19920615 OTC MONOGRAPH FINAL part347 Geiss, Destin and Dunn, Inc PETROLATUM 1 g/g 75981-124_ecfe8535-bb84-4407-bfb6-fccf7325b649 75981-124 HUMAN OTC DRUG Goodsense Extra Strength Cold and Hot Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Geiss, Destin and Dunn, Inc. MENTHOL 750 mg/1 75981-125_b0cc42b4-b957-4d23-b909-fb16348ea5da 75981-125 HUMAN OTC DRUG Goodsense Extra Strength Cold and Hot medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Geiss, Destin and Dunn, Inc. MENTHOL 750 mg/1 75981-153_ebfb59d3-5808-4b68-b2ad-fa798ad034b9 75981-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090518 OTC MONOGRAPH FINAL part358H Geiss, Destin + Dunn, Inc PYRITHIONE ZINC 1 g/100mL 75981-210_e5a7d306-dcea-45ae-984a-ce6342917de0 75981-210 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL MOUTHWASH ORAL 19930709 OTC MONOGRAPH NOT FINAL part348 Geiss, Destin + Dunn EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 75981-213_35497993-615b-4e57-87a8-da03214720ec 75981-213 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20070817 OTC MONOGRAPH FINAL part355 Geiss, Destin + Dunn, Inc SODIUM FLUORIDE .05 kg/100L 75981-226_657a4902-7aa7-47b9-b1a1-34143e078518 75981-226 HUMAN OTC DRUG Creamy Diaper Rash Zinc Oxide OINTMENT TOPICAL 19931027 OTC MONOGRAPH FINAL part347 Geiss, Destin + Dunn, Inc ZINC OXIDE 13 kg/100kg 75981-299_3780f82a-1779-4852-93e3-427719802972 75981-299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 19930920 OTC MONOGRAPH NOT FINAL part356 Geiss, Destin and Dunn, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL 75981-318_06eff263-2357-4626-a29b-6ae5b42cc3bf 75981-318 HUMAN OTC DRUG Antiseptic Eucayptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19900915 OTC MONOGRAPH NOT FINAL part356 Geiss, Destin + Dunmn, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L 75981-370_160c1bec-33a8-4c3e-bd30-963f1d94d9c5 75981-370 HUMAN OTC DRUG Advanced Ethyl Alcohol GEL TOPICAL 20120920 OTC MONOGRAPH NOT FINAL part333A Geiss, Destin + Dunn, Inc ALCOHOL 70 kg/100L 75981-602_9a1f35b8-a437-47ed-8765-6f1c08a8ab47 75981-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 19920715 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin and Dunn, Inc MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g 75981-664_5df1eb70-56ac-4cf8-a9f8-94dd4b52739f 75981-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19921001 OTC MONOGRAPH NOT FINAL part356 Geiss, Destin + Dunn, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL 75981-667_372bc4ef-9189-443a-ae33-35f6e935481d 75981-667 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 20090518 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin & Dunn, Inc. MAGNESIUM CITRATE 1.745 g/29.61mL 75981-686_c71b1bc6-168f-4608-9143-0325ca73224c 75981-686 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20090518 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin & Dunn, Inc. MAGNESIUM CITRATE 1.745 g/29.61mL 75981-693_6d1c9200-a777-489a-8700-b28534445827 75981-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20090518 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin & Dunn, Inc. MAGNESIUM CITRATE 1.745 g/29.61mL 75981-909_c632ad07-fa27-46a7-b3d8-ec0586d53c62 75981-909 HUMAN OTC DRUG Beauty Hydrating Octinoxate, Zinc Oxide LOTION TOPICAL 20061108 OTC MONOGRAPH NOT FINAL part352 Geiss, Destin + Dunn, Inc OCTINOXATE; ZINC OXIDE 61.2; 30.6 mg/mL; mg/mL 75983-000_3a73150d-1f03-4eb0-a402-1abb1bcd01ef 75983-000 HUMAN OTC DRUG First Aid Antibiotic Bacitraycin Plus Bacitracin CREAM TOPICAL 20130630 OTC MONOGRAPH FINAL part333B First Aid Research Corp. BACITRACIN 500 [USP'U]/g 75983-003_37cb9844-d639-46ce-913e-8057f7c08fa5 75983-003 HUMAN OTC DRUG First Aid Original Bacitraycin Plus Bacitraycin OINTMENT TOPICAL 20140305 OTC MONOGRAPH FINAL part333B First Aid Research Corp. BACITRACIN 500 [USP'U]/g 75983-420_dcb0b4c4-5cc7-463f-ad26-0d1f493fa048 75983-420 HUMAN OTC DRUG First Aid Research Antifungal .5oz Clotrimazole CREAM TOPICAL 20141014 OTC MONOGRAPH FINAL part333C First Aid Research Corp. CLOTRIMAZOLE 10 mg/g 75983-464_fca0c59d-8a8f-405b-80ab-d70a31ad7fab 75983-464 HUMAN OTC DRUG First Aid Research Antifungal Cream 1oz Clotrimazole CREAM TOPICAL 20141014 OTC MONOGRAPH FINAL part333C First Aid Research Corp. CLOTRIMAZOLE 10 mg/g 75983-495_3c1b34e4-3db3-465a-b220-0f15640bd63f 75983-495 HUMAN OTC DRUG First Aid Macimum Sterngth Bacitraycin Plus Bacitracin OINTMENT TOPICAL 20130630 OTC MONOGRAPH FINAL part333B First Aid Research Corp BACITRACIN; LIDOCAINE 500; 40 [USP'U]/g; mg/g 75983-515_1b89ee06-bee4-4eff-a7ce-19895a877bb6 75983-515 HUMAN OTC DRUG First Aid Antifungal Medicated Cream 0.5 oz Tolnaftate CREAM TOPICAL 20141009 OTC MONOGRAPH FINAL part333C First Aid Reserach Corp TOLNAFTATE 10 mg/g 75983-537_c7319ee5-9106-4f5c-b9e0-1d5cb5e0cc7b 75983-537 HUMAN OTC DRUG First Aid Antifungal Medicated Cream 1oz Tolnaftate CREAM TOPICAL 20141009 OTC MONOGRAPH FINAL part333C First Aid Reserach Corp TOLNAFTATE 10 mg/g 75983-555_3579504f-9904-4be5-862c-09424f6f0fc1 75983-555 HUMAN OTC DRUG First Aid Research Bacitraycin Plus Maximum Vertical Bacitracin Lidocaine OINTMENT TOPICAL 20140306 OTC MONOGRAPH FINAL part333B First Aid Research Corp. BACITRACIN; LIDOCAINE 500; 40 [USP'U]/g; mg/g 75983-738_b55dceb1-8133-4df6-b070-4810666a951f 75983-738 HUMAN OTC DRUG FIRST AID RESEARCH CHAFE AWAY MEDICATED HEALING MENTHOL AND ZINC OXIDE OINTMENT TOPICAL 20130101 OTC MONOGRAPH FINAL part347 FIRST AID RESEARCH CORP. MENTHOL; ZINC OXIDE .44; 20 g/100g; g/100g 75984-001_e5506944-d50a-4086-8976-f6e608b87cf8 75984-001 HUMAN OTC DRUG NEW DOCTOR AG PLUS GOLD SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20100901 OTC MONOGRAPH FINAL part355 HANIL PHARMACEUTICAL CO., LTD. SODIUM MONOFLUOROPHOSPHATE .15 g/150g 75987-010_c54a0fd6-bb6a-4589-a7fd-2e9aac0e445c 75987-010 HUMAN PRESCRIPTION DRUG DUEXIS Ibuprofen and Famotidine TABLET, COATED ORAL 20110429 NDA NDA022519 Horizon Pharma Inc. FAMOTIDINE; IBUPROFEN 26.6; 800 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 75987-020_2e32d121-bd9c-442f-a8d2-83672df13e7b 75987-020 HUMAN PRESCRIPTION DRUG RAYOS prednisone TABLET, DELAYED RELEASE ORAL 20120727 NDA NDA202020 Horizon Pharma Inc. PREDNISONE 1 mg/1 75987-021_2e32d121-bd9c-442f-a8d2-83672df13e7b 75987-021 HUMAN PRESCRIPTION DRUG RAYOS prednisone TABLET, DELAYED RELEASE ORAL 20120727 NDA NDA202020 Horizon Pharma Inc. PREDNISONE 2 mg/1 75987-022_2e32d121-bd9c-442f-a8d2-83672df13e7b 75987-022 HUMAN PRESCRIPTION DRUG RAYOS prednisone TABLET, DELAYED RELEASE ORAL 20120727 NDA NDA202020 Horizon Pharma Inc. PREDNISONE 5 mg/1 75987-030_18a4cb32-c363-4e7b-ae0d-fb75ddc33216 75987-030 HUMAN PRESCRIPTION DRUG Vimovo Naproxen and Esomeprazole Magnesium TABLET, DELAYED RELEASE ORAL 20140101 NDA NDA022511 Horizon Pharma Inc. ESOMEPRAZOLE MAGNESIUM; NAPROXEN 20; 500 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 75987-031_18a4cb32-c363-4e7b-ae0d-fb75ddc33216 75987-031 HUMAN PRESCRIPTION DRUG Vimovo Naproxen and Esomeprazole Magnesium TABLET, DELAYED RELEASE ORAL 20140101 NDA NDA022511 Horizon Pharma Inc. ESOMEPRAZOLE MAGNESIUM; NAPROXEN 20; 375 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 75989-550_9ae48262-aeb4-11e3-a5e2-0800200c9a66 75989-550 HUMAN PRESCRIPTION DRUG Aerospan flunisolide AEROSOL, METERED RESPIRATORY (INHALATION) 20120301 NDA NDA021247 Acton Pharmaceuticals, Inc. FLUNISOLIDE 80 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 75990-007_87ae6fae-62b6-42f3-9e18-394f2c039677 75990-007 HUMAN OTC DRUG Celox Ultra ALCOHOL LIQUID TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. ALCOHOL .7 mL/mL 75990-221_35324617-5ece-4d58-ade3-60838136be9e 75990-221 HUMAN OTC DRUG Celox Antiseptic ALCOHOL GEL TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. ALCOHOL .7 mL/mL 75990-300_25e7f9a9-a63b-4f71-8fa5-547e80d08c8a 75990-300 HUMAN OTC DRUG Purgo Ultra PC CHLOROXYLENOL SOAP TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. CHLOROXYLENOL 6 mg/mL 75990-3018_8d98ed62-13c8-4cff-87cc-4420b14faf8a 75990-3018 HUMAN OTC DRUG Certus Alcohol Prep ISOPROPYL ALCOHOL SWAB TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333A Certus Medical, Inc. ISOPROPYL ALCOHOL .7 mL/mL 75990-3111_4953d7ab-9b9e-434e-9bdb-c04d0d4a0199 75990-3111 HUMAN OTC DRUG Certus Alcohol Prep ISOPROPYL ALCOHOL SWAB TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333A Certus Medical, Inc. ISOPROPYL ALCOHOL .7 mL/mL 75990-365_01d51044-b305-4c8e-817b-4ad616583aa5 75990-365 HUMAN OTC DRUG Recens Ultra ALCOHOL LOTION TOPICAL 20110728 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. ALCOHOL .7 mL/mL 75990-4019_fc50a967-7f03-44c3-80e5-ebd469a9c979 75990-4019 HUMAN OTC DRUG Certus PVP-1 Prep Swabstick POVIDONE-IODINE SWAB TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. POVIDONE-IODINE .1 mL/mL 75990-5008_e5e298f9-51c0-42ed-bc49-163b6a8a2c9a 75990-5008 HUMAN OTC DRUG Certus BZK Antiseptic Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333A Certus Medical, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL 75990-5018_dbe9775a-2a9d-4317-aa96-92b0c9e61366 75990-5018 HUMAN OTC DRUG Certus Antiseptic Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333A Certus Medical, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL 75990-5028_51a62225-1e11-45bd-9b56-8703e4e44253 75990-5028 HUMAN OTC DRUG Certus Wash Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333A Certus Medical, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL 75990-572_6da92fda-1e25-4b86-b7fa-b7404602e62f 75990-572 HUMAN OTC DRUG Purgo Ultra TRICLOSAN SOAP TOPICAL 20110429 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. TRICLOSAN 3 mg/mL 75990-575_54c76a08-929f-420a-b316-977ab50e76d4 75990-575 HUMAN OTC DRUG Secure BENZETHONIUM CHLORIDE LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. BENZETHONIUM CHLORIDE 2 mg/mL 75990-576_66918764-8f63-46db-8d27-0e41cd1c86ea 75990-576 HUMAN OTC DRUG Purgo Ultra Foam TRICLOSAN SOAP TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. TRICLOSAN 3 mg/mL 75990-605_c8b5c9ef-0ab3-4bb7-ab31-5294f28adb07 75990-605 HUMAN OTC DRUG Recens ALCOHOL GEL TOPICAL 20110519 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. ALCOHOL .7 mL/mL 75990-7008_ecba17ad-283a-422b-9d84-3a19cc9783c9 75990-7008 HUMAN OTC DRUG Certus Sting Relief Prep Pad BENZOCAINE SWAB TOPICAL 20110501 OTC MONOGRAPH FINAL part348 Certus Medical, Inc. BENZOCAINE .06 mL/mL 75990-773_af64a9ac-a2cb-4f14-a187-5267d9730607 75990-773 HUMAN OTC DRUG Recens A ALCOHOL AEROSOL, FOAM TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. ALCOHOL 620 mg/g 75990-783_a192b620-ab5e-4cec-840c-94170240997f 75990-783 HUMAN OTC DRUG Recens Hand Sanitizer Wipes ALCOHOL CLOTH TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. ALCOHOL 620 mg/g 75990-959_5e1b2182-a1c9-480d-a262-04950a3f1d90 75990-959 HUMAN OTC DRUG Purgo Satin Foam TRICLOSAN SOAP TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. TRICLOSAN 3 mg/mL 75990-968_8fdd46cf-4128-482f-81f2-0a87df1cb3b4 75990-968 HUMAN OTC DRUG Recens Foam ALCOHOL LIQUID TOPICAL 20110519 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. ALCOHOL .7 mL/mL 75992-0004_bf218557-5d81-42ac-ba3c-20d75eccd9f4 75992-0004 HUMAN OTC DRUG Advantage Weight Loss and Hunger Control Natural Medicine LIQUID ORAL 20111207 UNAPPROVED HOMEOPATHIC Bouari Clinic ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CHLORIDE DIHYDRATE; BOS TAURUS HYPOTHALAMUS; CLAVICEPS PURPUREA SCLEROTIUM; FUCUS VESICULOSUS; GRAPHITE; HELLEBORUS NIGER ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS IGNATII SEED; THYMUS SERPYLLUM; THYROID, UNSPECIFIED; TRIBASIC CALCIUM PHOSPHATE 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 8; 8; 8; 8 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 75997-011_5124e681-9799-49ef-b539-aba1c901e147 75997-011 HUMAN OTC DRUG Vanilla Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL 75997-012_30188485-116b-471b-a786-e23aae3a5a65 75997-012 HUMAN OTC DRUG Unscented Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL 75997-014_84bc30bc-8928-41e5-ba41-fde8c1d18a6e 75997-014 HUMAN OTC DRUG Raspberry Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL 75997-018_edcef76c-9b31-413f-aa7f-7ad9c3857d5e 75997-018 HUMAN OTC DRUG Vanilla Fig Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL 75997-019_a6218fc5-4437-4e87-b73c-d8a89e777bf5 75997-019 HUMAN OTC DRUG Pomegranate Rose Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL 75997-020_55a4d96b-9c52-4989-928d-4378119e14be 75997-020 HUMAN OTC DRUG Honeysuckle Ginger Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL 75997-021_9caf9ca3-3e12-4f84-b759-912bfb60249b 75997-021 HUMAN OTC DRUG Sunkissed Honeydew Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL 75997-022_f082cad4-665e-48cb-8e9f-6020d0fb595e 75997-022 HUMAN OTC DRUG Coconut Vanilla Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL 75997-023_de45a87c-9518-494a-9224-46475c880e54 75997-023 HUMAN OTC DRUG Aqua Sunset Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL 75997-024_5bba53fe-5954-4c79-9a46-04b7e11a1b57 75997-024 HUMAN OTC DRUG Lemon Lime Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL 75997-025_3a3c942c-5a75-4370-8795-9b85d9b25d15 75997-025 HUMAN OTC DRUG Strawberry Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL 75997-026_57ca0e0a-2d23-4ada-bf4a-e82e080a67d7 75997-026 HUMAN OTC DRUG Vanilla Hand Sanitizer with Vitamin E and Aloe ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL 75997-027_47dfc2bd-f8d9-429e-aabb-39f7515448d3 75997-027 HUMAN OTC DRUG Gum Drop Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL 75997-028_c637b1c8-d2ae-45fa-aa71-a3fc73105c31 75997-028 HUMAN OTC DRUG Peppermint Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL 75997-029_9b154db6-3d76-446b-b25f-546869a62d55 75997-029 HUMAN OTC DRUG Frosted Berry Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL 75997-030_ccfd5ae0-44a6-41bc-b0c8-8e0cccbb148d 75997-030 HUMAN OTC DRUG Hand Sanitizer Gift Set 3-pack ALCOHOL KIT 20110706 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. DBA Noteworthy 76000-179_595445fb-4e15-443b-b3ed-73d2da14eedd 76000-179 HUMAN OTC DRUG St. Joseph Chewable Aspirin ASPIRIN TABLET, CHEWABLE ORAL 20120305 OTC MONOGRAPH NOT FINAL part343 Ilex Consumer Products Group, LLC ASPIRIN 81 mg/1 76000-180_7e89e155-a8e3-4f0e-9081-849324d698e4 76000-180 HUMAN OTC DRUG St. Joseph Safety Coated Aspirin ASPIRIN TABLET, COATED ORAL 20120305 OTC MONOGRAPH NOT FINAL part343 Ilex Consumer Products Group, LLC ASPIRIN 81 mg/1 76000-231_eb2bcdef-55ff-4486-892f-15d2124d36ca 76000-231 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20140530 OTC MONOGRAPH FINAL part343 Bedrock Brands, LLC (ST. JOSEPH) ASPIRIN 81 mg/1 76000-370_6d51f232-9a44-49f3-9f22-f0b3947c8daa 76000-370 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20120315 OTC MONOGRAPH FINAL part343 ILEX Consumer Products Group, LLC (ST. JOSEPH) ASPIRIN 325 mg/1 76000-375_ccdd1aec-6d5c-40c7-8e82-24aeaa1493a5 76000-375 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl CAPSULE ORAL 20050503 ANDA ANDA076497 Bedrock Brands, LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 76000-411_f0ac3d48-1ba8-4a0f-b5c8-0a79b8096cca 76000-411 HUMAN OTC DRUG Cough and Cold Relief HBP Chlorpheniramine maleate and Dextromethorphan HBr TABLET ORAL 20030503 OTC MONOGRAPH FINAL part341 Ilex Consumer Products Group, LLC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 76000-414_2cd3804f-f1ed-408f-8096-3b2dd11a74f7 76000-414 HUMAN OTC DRUG Adult Low Strength Aspirin Aspirin TABLET, COATED ORAL 20040114 OTC MONOGRAPH FINAL part343 Ilex Consumer Products Group, LLC ASPIRIN 81 mg/1 76000-460_80fdd075-f435-4c91-9a8f-ad36b594acd8 76000-460 HUMAN OTC DRUG High Blood Pressure Cold and Flu Acetaminophen and Chlorpheniramine Maleate TABLET, COATED ORAL 20050531 OTC MONOGRAPH NOT FINAL part343 Ilex Consumer Products Group, LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 325; 2 mg/1; mg/1 76000-461_297bd265-f054-4cfe-8af9-87c63d7511c1 76000-461 HUMAN OTC DRUG Maximum Strength Flu HBP Acetaminophen, Dextromethorphan HBr, Chlorpheniramine maleate TABLET, FILM COATED ORAL 20050601 OTC MONOGRAPH NOT FINAL part343 Ilex Consumer Products Group, LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 500; 2; 15 mg/1; mg/1; mg/1 76000-533_085e5deb-b53a-4e69-8f57-45f568db34e4 76000-533 HUMAN OTC DRUG High Blood Pressure Chest Congestion and Cough Dextromethorphan HBr and Guiafenesin TABLET, FILM COATED ORAL 20051231 OTC MONOGRAPH FINAL part341 Ilex Consumer Products Group, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 76007-011_90411ee3-f9eb-463b-96d5-d2dc4b3e2dcd 76007-011 HUMAN OTC DRUG First Aid Pocket Pack - 40 Pieces BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE, ISOPROPYL ALCOHOL, BENZALKONIUM CHLORIDE KIT 20110204 OTC MONOGRAPH NOT FINAL part333A Ready America, Inc. 76007-012_aeec6803-ea14-44db-8766-26dbc8185f69 76007-012 HUMAN OTC DRUG First Aid Value Pack - 77 Pieces BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE, ISOPROPYL ALCOHOL, BENZALKONIUM CHLORIDE KIT 20110204 OTC MONOGRAPH NOT FINAL part333A Ready America, Inc. 76008-1272_6f8eacc4-e0d3-4c44-9297-38e739145eae 76008-1272 HUMAN OTC DRUG Comfort Touch Antibacterial Moist Wipes Benzalkonium Chloride SWAB TOPICAL 20110216 OTC MONOGRAPH NOT FINAL part333A Sintal International Inc DBA Comfort Touch BENZALKONIUM CHLORIDE .13 g/100g 76014-001_40b93b60-b073-4842-b66e-5dfd491e4cfa 76014-001 HUMAN PRESCRIPTION DRUG Hycet hydrocodone bitartrate and acetaminophen SYRUP ORAL 20110801 ANDA ANDA040482 Eclat Pharmaceuticals, LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 76014-002_d3e91f6c-b7de-4abb-a11f-6fbb42432fcc 76014-002 HUMAN PRESCRIPTION DRUG Bloxiverz Neostigmine Methylsulfate INJECTION INTRAVENOUS 20130724 NDA NDA204078 Eclat Pharmaceuticals, LLC NEOSTIGMINE METHYLSULFATE .5 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 76014-003_d3e91f6c-b7de-4abb-a11f-6fbb42432fcc 76014-003 HUMAN PRESCRIPTION DRUG Bloxiverz Neostigmine Methylsulfate INJECTION INTRAVENOUS 20130724 NDA NDA204078 Eclat Pharmaceuticals, LLC NEOSTIGMINE METHYLSULFATE 1 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 76014-004_6027cc40-329e-11e4-8c21-0800200c9a66 76014-004 HUMAN PRESCRIPTION DRUG Vazculep Phenylephrine Hydrochloride INJECTION INTRAVENOUS 20140701 NDA NDA204300 Eclat Pharmaceuticals, LLC PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] 76015-100_765acac5-0d77-46f7-851e-db3e320cdd33 76015-100 HUMAN OTC DRUG DR DEEP MULTIEMULSION GLYCERIN ALLANTOIN EMULSION TOPICAL 20110410 OTC MONOGRAPH FINAL part347 MineralHouse Corporation ALLANTOIN; GLYCERIN .45; 9 mL/150mL; mL/150mL 76015-200_bdd27bb8-dd0f-489f-ad37-01ff9ed422b3 76015-200 HUMAN OTC DRUG DR DEEP SKINTONER GLYCERIN ALLANTOIN LOTION TOPICAL 20110410 OTC MONOGRAPH FINAL part347 MineralHouse Corporation ALLANTOIN; GLYCERIN .2; 4 mL/200mL; mL/200mL 76015-300_21075960-6851-4a6b-8090-59a4ea2f2cd0 76015-300 HUMAN OTC DRUG DR DEEP SKINTONER GLYCERIN ALLANTOIN LOTION TOPICAL 20120101 OTC MONOGRAPH FINAL part347 MineralHouse Corporation ALLANTOIN; GLYCERIN .2; 2 mL/200mL; mL/200mL 76015-400_ed677e76-e9c4-4ae9-b274-b1abdc050afd 76015-400 HUMAN OTC DRUG DR DEEP AQUA WRINKLECREAM ALLANTOIN ADENOSINE CREAM TOPICAL 20120101 OTC MONOGRAPH FINAL part347 MineralHouse Corporation ADENOSINE; ALLANTOIN .04; 1 mL/100mL; mL/100mL 76016-544_6b75cea8-8adf-4f87-aec9-dfa2b69b9fa9 76016-544 HUMAN OTC DRUG Pure Kleen CHLOROXYLENOL SOAP TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Arrow-Magnolia International, Inc. CHLOROXYLENOL .003 mL/mL 76017-100_26115390-560e-4ab2-8add-6c9ac141bbd6 76017-100 HUMAN OTC DRUG Australian Dream Pain Relieving Arthritis HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part348 Nature's Health Connection HISTAMINE DIHYDROCHLORIDE .025 g/100g 76017-200_bdeaa4bc-25be-481d-900e-66db9e96fab8 76017-200 HUMAN OTC DRUG Australian Dream Back Pain Cream HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20140710 OTC MONOGRAPH NOT FINAL part348 Nature's Health Connection HISTAMINE DIHYDROCHLORIDE .05 g/g 76018-100_14d2bd62-08f7-4dcf-b7ec-1695832c4a6b 76018-100 HUMAN OTC DRUG Arth Arrest METHYL NICOTINATE, CAPSAICIN CREAM TOPICAL 20110211 OTC MONOGRAPH FINAL part348 Key 2 Health, Inc. CAPSAICIN; METHYL NICOTINATE .025; .5 g/100g; g/100g 76019-100_ab59381e-5d2a-43f4-b5ba-1e8a69c4829b 76019-100 HUMAN OTC DRUG BioRelief Ice Pain Relieving MENTHOL SPRAY TOPICAL 20110214 OTC MONOGRAPH FINAL part348 Mekt, LLC MENTHOL 59 mL/100mL 76020-100_7a5e27d2-3c36-402e-ace4-cf2b6955e7ab 76020-100 HUMAN OTC DRUG HomeHealth Antifungal TOLNAFTATE LOTION TOPICAL 20110214 OTC MONOGRAPH FINAL part333C Home Health TOLNAFTATE 1 mL/100mL 76020-200_35d2aa94-53fd-4be5-865f-9f411db2cb20 76020-200 HUMAN OTC DRUG Home Health Everclean Antidandruff SALICYLIC ACID SHAMPOO TOPICAL 20110214 OTC MONOGRAPH FINAL part358H Home Health SALICYLIC ACID 1.8 mL/100mL 76020-300_36f31ffe-61b4-41c7-9c67-e89597088b2f 76020-300 HUMAN OTC DRUG Home Health Psoriasis Medicated Scalp and Body Wash SALICYLIC ACID LIQUID TOPICAL 20110212 OTC MONOGRAPH FINAL part358H Home Health SALICYLIC ACID 2 mL/100mL 76020-400_37c270a7-3b07-452a-99d3-5b45f3a182cb 76020-400 HUMAN OTC DRUG Home Health Psoriasis SALICYLIC ACID CREAM TOPICAL 20110213 OTC MONOGRAPH FINAL part358H Home Health SALICYLIC ACID 2 g/100g 76021-100_5f0cc147-aa59-4211-bc7d-35391502e9ec 76021-100 HUMAN OTC DRUG Life Extension Sun Protection SPF 30 OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE SPRAY TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part352 LifeExtension Foundation AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE .65; 7.5; 3; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL 76025-100_106c0b56-b42e-4d3f-aebd-c625bae8e2e6 76025-100 HUMAN OTC DRUG Color Me With KidsUV SPF30 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20110211 OTC MONOGRAPH FINAL part352 Kids uv Suncare Products TITANIUM DIOXIDE; ZINC OXIDE 6; 6 mL/100mL; mL/100mL 76026-200_172c35eb-36de-a788-1b1f-8bc5100b0f34 76026-200 HUMAN OTC DRUG puristics baby zinc oxide diaper rash zinc oxide CREAM TOPICAL 20101220 OTC MONOGRAPH NOT FINAL part347 Scerene Healthcare, Inc. ZINC OXIDE 15 g/100g 76026-204_60c21025-8be5-98d6-cf9a-bff672eb9224 76026-204 HUMAN OTC DRUG puristics totally ageless spf 15 daily anti-aging zinc oxide LOTION TOPICAL 20101220 OTC MONOGRAPH NOT FINAL part352 Scerene Healthcare, Inc. ZINC OXIDE 7.5 mL/100mL 76026-304_5f4eb2f6-04e3-8103-88ea-bb3b615c8174 76026-304 HUMAN OTC DRUG puristics totallyageless spf 15 daily anti-aging octisalate, zinc oxide LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Scerene Healthcare, Inc. OCTISALATE; ZINC OXIDE 5; 3.75 mL/100mL; mL/100mL 76029-001_6eb185c2-a897-4ae6-9c38-18f31e66ac60 76029-001 HUMAN OTC DRUG Pain Relief Ruta Graveolens CREAM TOPICAL 20110401 UNAPPROVED HOMEOPATHIC Active Release Techniques LLC RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]/50g 76029-002_9757bc14-c08d-41bb-a310-3d6c9fc11de7 76029-002 HUMAN OTC DRUG Nerve Pain Relief Capsicum CREAM TOPICAL 20110420 UNAPPROVED HOMEOPATHIC Active Release Techniques CAPSICUM 2 [hp_C]/50g 76029-003_6b19cb05-d693-4975-abe9-25409fe02c9f 76029-003 HUMAN OTC DRUG Wound Healing Calendula Officinalis CREAM TOPICAL 20110420 UNAPPROVED HOMEOPATHIC Active Release Techniques CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_C]/35g 76038-089_defa4f98-a2bd-4c36-84fd-23caf77f0020 76038-089 HUMAN OTC DRUG MEDITOWEL PAIN RELIEF MENTHOL CLOTH TOPICAL 20110101 OTC MONOGRAPH FINAL part348 MICRO CONNECTION ENTERPRISES INC MENTHOL .05 g/mL 76038-090_cbfa3113-13e3-4a50-a02c-648266d4bbb3 76038-090 HUMAN OTC DRUG MEDITOWEL ILLUMINATING SKIN BRIGHTENING HYDROQUINONE CLOTH TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A MICRO CONNECTION ENTERPRISES INC HYDROQUINONE 2 g/100mL 76038-091_c04c6bfd-96b5-4028-bd1a-b3f581b5931f 76038-091 HUMAN OTC DRUG MEDITOWEL ANTIBACTERIAL FIRST AID BENZOCAINE BENZALKONIUM CHLORIDE CLOTH TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333B MICRO CONNECTION ENTERPRISES INC BENZALKONIUM CHLORIDE; BENZOCAINE 2; 2 mg/mL; mg/mL 76041-712_00e135c8-ef9d-452f-b3c7-c33d88b12c66 76041-712 HUMAN OTC DRUG Moisturising Sunscreen SPF 30 ZINC OXIDE LOTION TOPICAL 20110610 OTC MONOGRAPH NOT FINAL part352 Neals Yard (Natural Remedies) Limited ZINC OXIDE 17.5 mL/100mL 76041-713_5c58de2e-9acc-48f2-b804-2b1aaaadbc44 76041-713 HUMAN OTC DRUG Wild Rose Daily Moisture Sunscreen SPF 30 ZINC OXIDE LOTION TOPICAL 20110610 OTC MONOGRAPH NOT FINAL part352 Neal's Yard (Natural Remedies) Limited ZINC OXIDE 19 mL/100mL 76045-001_d919e887-f70d-4382-80cf-05206eeee7b5 76045-001 HUMAN PRESCRIPTION DRUG Midazolam Midazolam Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20141003 ANDA ANDA203460 BD Rx Inc. MIDAZOLAM HYDROCHLORIDE 2 mg/2mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76045-002_d919e887-f70d-4382-80cf-05206eeee7b5 76045-002 HUMAN PRESCRIPTION DRUG Midazolam Midazolam Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20141003 ANDA ANDA203460 BD Rx Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76045-003_d919e887-f70d-4382-80cf-05206eeee7b5 76045-003 HUMAN PRESCRIPTION DRUG Midazolam Midazolam Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20141003 ANDA ANDA203460 BD Rx Inc. MIDAZOLAM HYDROCHLORIDE 10 mg/2mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76045-004_07a87d97-95a5-4899-a88c-9fb3966548b4 76045-004 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAVENOUS 20130214 NDA NDA204223 BD Rx Inc. MORPHINE SULFATE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 76045-005_07a87d97-95a5-4899-a88c-9fb3966548b4 76045-005 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAVENOUS 20130214 NDA NDA204223 BD Rx Inc. MORPHINE SULFATE 4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 76045-006_07a87d97-95a5-4899-a88c-9fb3966548b4 76045-006 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAVENOUS 20130214 NDA NDA204223 BD Rx Inc. MORPHINE SULFATE 5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 76045-007_07a87d97-95a5-4899-a88c-9fb3966548b4 76045-007 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAVENOUS 20130214 NDA NDA204223 BD Rx Inc. MORPHINE SULFATE 8 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 76045-008_07a87d97-95a5-4899-a88c-9fb3966548b4 76045-008 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAVENOUS 20130214 NDA NDA204223 BD Rx Inc. MORPHINE SULFATE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 76045-101_0e8a5b93-2504-48c6-b014-71ae5e2bd43a 76045-101 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130503 ANDA ANDA091392 BD Rx Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/2mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 76045-102_56ed5882-f9dc-4c84-adef-8442d2567d9c 76045-102 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130408 ANDA ANDA091526 BD Rx Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 76045-103_f627d6eb-6336-4633-8f36-dc6ea9e901c8 76045-103 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130823 ANDA ANDA202253 BD Rx Inc. ONDANSETRON HYDROCHLORIDE 4 mg/2mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] 76049-001_dd9b9e6c-f24d-4c00-8e1c-98960314caf4 76049-001 HUMAN OTC DRUG stila CC color correcting broad-spectrum SPF 20 01 FAIR OCTOCRYLENE, OCTISALATE, AVOBENZONE, OCTINOXATE STICK TOPICAL 20130228 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 15; 65; 40; 40 mg/g; mg/g; mg/g; mg/g 76049-002_07758ac1-72f7-4a33-9e0a-d204342b758c 76049-002 HUMAN OTC DRUG stila CC color correcting broad-spectrum SPF 20 02 LIGHT OCTOCRYLENE, OCTISALATE, AVOBENZONE, OCTINOXATE STICK TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 15; 65; 40; 40 mg/g; mg/g; mg/g; mg/g 76049-003_cbc96697-82cf-4e71-b39f-762a752582d2 76049-003 HUMAN OTC DRUG stila CC color correcting broad-spectrum SPF 20 03 TONE OCTOCRYLENE, OCTISALATE, AVOBENZONE, OCTINOXATE STICK TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 15; 65; 40; 40 mg/g; mg/g; mg/g; mg/g 76049-004_15e72b7e-62d8-45a1-aa8c-3ec1b9fe2d10 76049-004 HUMAN OTC DRUG stila CC color correcting broad-spectrum SPF 20 04 MEDIUM OCTOCRYLENE, OCTISALATE, AVOBENZONE, OCTINOXATE STICK TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 15; 65; 40; 40 mg/g; mg/g; mg/g; mg/g 76049-005_8e00156e-2843-4329-9b0b-92a4e2a597b1 76049-005 HUMAN OTC DRUG stila CC color correcting broad-spectrum SPF 20 05 RICH MEDIUM OCTOCRYLENE, OCTISALATE, AVOBENZONE, OCTINOXATE STICK TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 15; 65; 40; 40 mg/g; mg/g; mg/g; mg/g 76049-006_69a67886-8134-448b-9d66-0eaa1ae0994b 76049-006 HUMAN OTC DRUG stila CC color correcting broad-spectrum SPF 20 06 WARM OCTOCRYLENE, OCTISALATE, AVOBENZONE, OCTINOXATE STICK TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 15; 65; 40; 40 mg/g; mg/g; mg/g; mg/g 76049-007_c924b10c-279f-402e-a525-4f6bb8512ff7 76049-007 HUMAN OTC DRUG stila CC color correcting broad-spectrum SPF 20 07 DARK OCTOCRYLENE, OCTISALATE, AVOBENZONE, OCTINOXATE STICK TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 15; 65; 40; 40 mg/g; mg/g; mg/g; mg/g 76049-008_e6d2ff0c-bfe4-4bca-8970-39b898331deb 76049-008 HUMAN OTC DRUG stila CC color correcting broad-spectrum SPF 20 08 TAN OCTOCRYLENE, OCTISALATE, AVOBENZONE, OCTINOXATE STICK TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 15; 65; 40; 40 mg/g; mg/g; mg/g; mg/g 76049-121_89d9b005-7f25-436a-a976-38c75dab56b7 76049-121 HUMAN OTC DRUG jane Be Beautiful Multi-Benefit BB Broad Spectrum SPF 30 Dark OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20131031 OTC MONOGRAPH NOT FINAL part352 Stila Styles OCTINOXATE; ZINC OXIDE 50; 186 mg/mL; mg/mL 76049-122_89d9b005-7f25-436a-a976-38c75dab56b7 76049-122 HUMAN OTC DRUG jane Be Beautiful Multi-Benefit BB Broad Spectrum SPF 30 Medium OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20131031 OTC MONOGRAPH NOT FINAL part352 Stila Styles OCTINOXATE; ZINC OXIDE 50; 186 mg/mL; mg/mL 76049-123_89d9b005-7f25-436a-a976-38c75dab56b7 76049-123 HUMAN OTC DRUG jane Be Beautiful Multi-Benefit BB Broad Spectrum SPF 30 Light OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20131031 OTC MONOGRAPH NOT FINAL part352 Stila Styles OCTINOXATE; ZINC OXIDE 50; 186 mg/mL; mg/mL 76049-554_0c87966d-a42a-45f3-9301-e38c61b37f7e 76049-554 HUMAN OTC DRUG stila bronzing tinted moisturizer oil-free SPF 20 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20130831 OTC MONOGRAPH FINAL part347 Stila Styles, LLC TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL 76049-555_cde70a36-38fa-44b4-9036-d6a5b1ea7a48 76049-555 HUMAN OTC DRUG Stila illuminating tinted moisturizer broad spectrum SPF 20 (All Shades) Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20130831 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL 76049-556_2c27ca70-fb9b-4c9f-9c78-93f9a6dc7c03 76049-556 HUMAN OTC DRUG Stila Sheer color tinted moisturizer BS SPF20 (All Shades) Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20130831 OTC MONOGRAPH FINAL part347 Stila Styles, LLC TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL 76049-620_2b674434-a7bf-4d46-88b9-29cfbc5cfdf7 76049-620 HUMAN OTC DRUG stila illuminate and shine Octinoxate, Avobenzoate, and Octisalate KIT 20130831 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC 76049-715_388fe1a5-c183-4bdd-a6ac-e491714c5161 76049-715 HUMAN OTC DRUG Stila Hydrating Primer Oil-Free SPF 30 (All Shades) Avobenzone, Octisalate, and Octinoxate LOTION TOPICAL 20130830 OTC MONOGRAPH FINAL part352 Stila Styles, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 mg/mL; mg/mL; mg/mL 76049-877_44d23dcb-2f83-4a53-b31c-a95ec6fc0c32 76049-877 HUMAN OTC DRUG Stila Stay All Day 10-in-1 HD Beauty Balm Broad Spectrum SPF 30 OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20130831 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC OCTINOXATE; ZINC OXIDE 50; 186 mg/mL; mg/mL 76049-879_41edcff8-9174-4870-9a70-dad66add9f83 76049-879 HUMAN OTC DRUG Stila Stay All Day 10-in-1 HD Illuminating Beauty Balm Broad Spectrum SPF 30 OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20130831 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC OCTINOXATE; ZINC OXIDE 50; 186 mg/mL; mg/mL 76049-899_e916e9be-077a-4f96-8bb9-ac6916f9d2ab 76049-899 HUMAN OTC DRUG Stila CC Color Correcting Broad-Spectrum SPF 20 (All Shades) Octocrylene, Octisalate, Avobenzone, and Octinoxate STICK TOPICAL 20130831 OTC MONOGRAPH FINAL part352 Stila Styles, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 15; 65; 40; 40 mg/g; mg/g; mg/g; mg/g 76049-906_fd45043a-ca8a-4284-868d-f940b7b19f33 76049-906 HUMAN OTC DRUG Stila Color Correcting Broad Spectrum SPF 20 (All Shades) OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 75; 50; 10 mg/mL; mg/mL; mg/mL 76053-001_6be7e206-e0d1-49a2-ad73-955dd8269be9 76053-001 HUMAN OTC DRUG Cargo Tinted Moisturizer SPF 20 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20110412 OTC MONOGRAPH FINAL part352 Cargo Cosmetics Corp. TITANIUM DIOXIDE; ZINC OXIDE 2.5; 2.5 mL/mL; mL/mL 76053-002_6be7e206-e0d1-49a2-ad73-955dd8269be9 76053-002 HUMAN OTC DRUG Cargo Tinted Moisturizer SPF 20 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20110412 OTC MONOGRAPH FINAL part352 Cargo Cosmetics Corp. TITANIUM DIOXIDE; ZINC OXIDE 2.5; 2.5 mL/mL; mL/mL 76053-003_6be7e206-e0d1-49a2-ad73-955dd8269be9 76053-003 HUMAN OTC DRUG Cargo Tinted Moisturizer SPF 20 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20110412 OTC MONOGRAPH FINAL part352 Cargo Cosmetics Corp. TITANIUM DIOXIDE; ZINC OXIDE 2.5; 2.5 mL/mL; mL/mL 76053-004_6be7e206-e0d1-49a2-ad73-955dd8269be9 76053-004 HUMAN OTC DRUG Cargo Tinted Moisturizer SPF 20 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20110412 OTC MONOGRAPH FINAL part352 Cargo Cosmetics Corp. TITANIUM DIOXIDE; ZINC OXIDE 2.5; 2.5 mL/mL; mL/mL 76056-001_403da693-ab6f-4b45-ac4e-6c2fb3cb7a34 76056-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS White's Inc. OXYGEN 99 L/100L 76058-100_9ea6b4ad-4980-4f58-8d7d-1a2875fba5c9 76058-100 HUMAN OTC DRUG SIRINMEDI ONE SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110301 OTC MONOGRAPH FINAL part355 Sungwon Pharmaceutical Co., Ltd. SODIUM MONOFLUOROPHOSPHATE 1460 mg/200g 76058-101_a642700c-81e5-4575-8986-67e0925d8963 76058-101 HUMAN OTC DRUG Newchito Plus One SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110301 OTC MONOGRAPH FINAL part355 Sungwon Pharmaceutical Co., Ltd. SODIUM MONOFLUOROPHOSPHATE 1452 mg/220g 76058-102_57e835b1-883a-4da7-bf8d-206fe898166f 76058-102 HUMAN OTC DRUG Apatite SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110301 OTC MONOGRAPH FINAL part355 Sungwon Pharmaceutical Co., Ltd. SODIUM MONOFLUOROPHOSPHATE 1380 mg/200g 76058-103_af1e41b4-c82d-49c7-b516-5292ab890826 76058-103 HUMAN OTC DRUG Dental guardian SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110602 OTC MONOGRAPH FINAL part355 Sungwon Pharmaceutical Co., Ltd. SODIUM MONOFLUOROPHOSPHATE 172 mg/25g 76058-104_a6bab6a8-c93f-46ff-a1a4-64ed552d931a 76058-104 HUMAN OTC DRUG Cool Ice SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20010805 OTC MONOGRAPH FINAL part355 Sungwon Pharmaceutical Co., Ltd. SODIUM MONOFLUOROPHOSPHATE 60 mg/120g 76058-105_a8304627-38ab-4d59-9ef1-72c842c6b1fc 76058-105 HUMAN OTC DRUG Anti E-Sirin SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20111011 OTC MONOGRAPH FINAL part355 Sungwon Pharmaceutical Co., Ltd. SODIUM MONOFLUOROPHOSPHATE 1460 mg/200g 76058-106_22c417e4-da00-4acf-871f-9cbcd2a64f8c 76058-106 HUMAN OTC DRUG APATITE PROFESSIONAL CALCIUM CARBONATE PASTE DENTAL 20130314 UNAPPROVED DRUG OTHER Sungwon Pharmaceutical Co., Ltd. CALCIUM CARBONATE 36.4 g/130g 76058-107_efd023ff-f0bd-4909-9efc-afd99ef57598 76058-107 HUMAN OTC DRUG ESIRIN X Sodium Monofluorophosphate PASTE DENTAL 20130331 OTC MONOGRAPH FINAL part355 Sungwon Pharmaceutical Co., Ltd. SODIUM MONOFLUOROPHOSPHATE 1.4 g/200g 76063-738_fb0a4a4e-74e6-4d6d-ac52-ff2ea95e061b 76063-738 HUMAN OTC DRUG Handi-Sani ALCOHOL LIQUID TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333E Chromate Industrial Corporation ALCOHOL .7 mL/mL 76063-773_658bf66d-8bcd-4e13-89fa-514b7259ea1e 76063-773 HUMAN OTC DRUG Sani-Smooth ALCOHOL AEROSOL, FOAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333E Chromate Industrial Corporation ALCOHOL 620 mg/g 76066-001_fdc5f262-151b-45ae-8e5c-c4ba982495a6 76066-001 HUMAN OTC DRUG EczeNil Colloidal Oatmeal CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part347 Healingsmith Institute Inc. OATMEAL 2.3 g/113.2g 76066-002_c2fa9e06-b36b-4b7a-90d1-31628423a1b6 76066-002 HUMAN OTC DRUG PsoraCare Salicylic Acid CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part358H Healingsmith Institute Inc. SALICYLIC ACID 1.1 g/56.7g 76067-100_63b83bc5-216e-4c28-adc9-e8ece493eaed 76067-100 HUMAN OTC DRUG SAVONE Skin Therapy Age Essentials SPF 30 Sports Sunscreen OCTINOXATE, OCTISALATE, OXYBENZONE SPRAY TOPICAL 20110211 OTC MONOGRAPH FINAL part352 Herbal Authority OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 3; 5 mL/100mL; mL/100mL; mL/100mL 76069-100_1dd421d5-ddc7-43e2-906c-28d619162292 76069-100 HUMAN OTC DRUG Arth RX Topical Analgesic METHYL NICOTINATE, CAPSAICIN LOTION TOPICAL 20110212 OTC MONOGRAPH FINAL part348 HCD Sales CAPSAICIN; METHYL NICOTINATE .025; .5 g/100g; g/100g 76070-100_0d3e268a-efe3-4641-894b-90a7d954a01c 76070-100 HUMAN OTC DRUG Bilboa Capri Sunscreen SPF 15 AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20110308 OTC MONOGRAPH FINAL part352 Cadey S.r.l. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 3; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL 76070-110_ecb642a6-8c81-48b9-96e2-aba76e934f31 76070-110 HUMAN OTC DRUG Bilboa Capri Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20110308 OTC MONOGRAPH FINAL part352 Cadey S.r.l. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 3; 2; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 76070-120_5659e368-7aa9-4e32-b43c-b5c9cec1e585 76070-120 HUMAN OTC DRUG Bilboa Capri Sunscreen SPF 50 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20110308 OTC MONOGRAPH FINAL part352 Cadey S.r.l. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 3; 2; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 76070-130_4bde1f2c-9b3f-4b8f-a43a-6902d4207a1f 76070-130 HUMAN OTC DRUG Bilboa Kids Sunscreen SPF 50 Plus HOMOSALATE, OCTISALATE, OXYBENZONE, ZINC OXIDE LOTION TOPICAL 20110308 OTC MONOGRAPH FINAL part352 Cadey S.r.l. HOMOSALATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 13; 3; 6; 11.52 mL/100mL; mL/100mL; mL/100mL; mL/100mL 76071-1001_b0d0e21d-fc62-4bd6-b94b-ed4b06d824d5 76071-1001 HUMAN OTC DRUG Stem Cell Renew adenosine CREAM TOPICAL 20110406 UNAPPROVED DRUG OTHER Medon Co., Ltd ADENOSINE .04 mL/mL 76071-2001_423b475b-deff-44b4-9e3f-1b0df7d76666 76071-2001 HUMAN OTC DRUG Stem Cell Wrinkle Serum adenosine LIQUID TOPICAL 20110406 UNAPPROVED DRUG OTHER Medon Co., Ltd ADENOSINE .0004 mL/mL 76071-3001_14cfdf50-cac6-4c94-83d8-ec7663ef920f 76071-3001 HUMAN OTC DRUG Stem Cell Whitening Serum NIACINAMIDE LIQUID TOPICAL 20110406 UNAPPROVED DRUG OTHER Medon Co., Ltd NIACINAMIDE .02 mL/mL 76074-120_343e2c19-1c1f-4fa9-9d25-42e696869d67 76074-120 HUMAN OTC DRUG Topical Pain Relief Methyl Salicylate, Menthol, capsaicin CREAM TOPICAL 20110115 OTC MONOGRAPH NOT FINAL part348 Two Hip Consulting, LLC CAPSAICIN; MENTHOL; METHYL SALICYLATE .0355; 5; 20 g/100g; g/100g; g/100g 76074-121_c7bf90c3-8f68-4674-8c25-4f742abe6502 76074-121 HUMAN OTC DRUG MEDI-DERM TOPICAL PAIN RELIEF METHYL SALICYLATE MENTHOL CAPSAICIN CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part348 Two Hip Consulting, LLC CAPSAICIN; MENTHOL; METHYL SALICYLATE .0355; 5; 20 g/100mL; g/100mL; g/100mL 76074-122_dbc0dfeb-7813-4108-9e47-b36d0113fc69 76074-122 HUMAN OTC DRUG MEDI-SULTING TOPICAL PAIN RELIEF METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE CREAM TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part348 Two Hip Consulting, LLC CAPSAICIN; LIDOCAINE; MENTHOL; METHYL SALICYLATE .0355; 4; 5; 20 g/100mL; g/100mL; g/100mL; g/100mL 76074-123_8faa67cb-c922-4aee-bb76-7c721d5e6528 76074-123 HUMAN OTC DRUG MEDI-SULTING TOPICAL PAIN RELIEF METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE PATCH TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part348 Two Hip Consulting, LLC CAPSAICIN; LIDOCAINE; MENTHOL; METHYL SALICYLATE .035; .5; 5; 20 g/100g; g/100g; g/100g; g/100g 76074-132_b18b0e40-4bd3-4b47-a454-b8f0eec82231 76074-132 HUMAN OTC DRUG MEDI-DERM / L WITH LIDOCAINE METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE CREAM TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part348 Two Hip Consulting, LLC CAPSAICIN; LIDOCAINE; MENTHOL; METHYL SALICYLATE .0355; 4; 5; 20 g/100mL; g/100mL; g/100mL; g/100mL 76074-133_f5862a9c-7a8d-436f-a698-1066ac127733 76074-133 HUMAN OTC DRUG MEDI-PATCH WITH LIDOCAINE CAPSAICIN, LIDOCAINE, MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part348 Two Hip Consulting, LLC CAPSAICIN; LIDOCAINE; MENTHOL; METHYL SALICYLATE .035; .5; 5; 20 g/1; g/1; g/1; g/1 76074-140_e203d87c-d0fd-4768-8a4f-4b414df846b2 76074-140 HUMAN PRESCRIPTION DRUG TOPICAL PAIN RELIEF RX METHYL SALICYLATE MENTHOL CAPSAICIN CREAM TOPICAL 20120818 UNAPPROVED DRUG OTHER Two Hip Consulting, LLC CAPSAICIN; MENTHOL; METHYL SALICYLATE .0355; 5; 20 g/100mL; g/100mL; g/100mL 76074-141_1f39b89b-a8c3-440a-a253-4ad20cdfd28a 76074-141 HUMAN PRESCRIPTION DRUG DOLORACIN RX METHYL SALICYLATE, MENTHOL AND CAPSAICIN CREAM TOPICAL 20130811 UNAPPROVED DRUG OTHER Two Hip Consulting, LLC CAPSAICIN; MENTHOL; METHYL SALICYLATE .035; 5; 20 g/100mL; g/100mL; g/100mL 76074-142_ecf39cad-335f-4475-b9d1-c342cf9d872a 76074-142 HUMAN PRESCRIPTION DRUG DOLORACIN/L RX WITH LIDOCAINE METHYL SALICYLATE, MENTHOL, CAPSAICIN AND LIDOCAINE CREAM TOPICAL 20130731 UNAPPROVED DRUG OTHER Two Hip Consulting, LLC CAPSAICIN; LIDOCAINE; MENTHOL; METHYL SALICYLATE .035; 4; 5; 20 g/100mL; g/100mL; g/100mL; g/100mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 76074-143_fd5884ef-8247-4c6e-ac69-06657b7684b4 76074-143 HUMAN PRESCRIPTION DRUG DOLOR-PARCHE WITH LIDOCAINE-RX CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE PATCH TOPICAL 20130731 UNAPPROVED DRUG OTHER Two Hip Consulting, LLC CAPSAICIN; LIDOCAINE; MENTHOL; METHYL SALICYLATE .035; .5; 5; 20 g/1; g/1; g/1; g/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 76074-151_35bc35b3-d6ae-4b75-8b7c-4e77c786238a 76074-151 HUMAN PRESCRIPTION DRUG MEDI-DERM RX METHYL SALICYLATE, MENTHOL AND CAPSAICIN CREAM TOPICAL 20120818 UNAPPROVED DRUG OTHER Two Hip Consulting, LLC CAPSAICIN; MENTHOL; METHYL SALICYLATE .035; 5; 20 g/100mL; g/100mL; g/100mL 76074-152_1f008948-cec7-43af-ada8-edd357f72304 76074-152 HUMAN PRESCRIPTION DRUG MEDI-DERM / L WITH LIDOCAINE RX METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE CREAM TOPICAL 20120818 UNAPPROVED DRUG OTHER Two Hip Consulting, LLC CAPSAICIN; LIDOCAINE; MENTHOL; METHYL SALICYLATE .0355; 4; 5; 20 g/100mL; g/100mL; g/100mL; g/100mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 76074-153_8e8ddf61-2d9f-48b3-9b59-501c5e0a7d23 76074-153 HUMAN PRESCRIPTION DRUG MEDI-PATCH WITH LIDOCAINE RX CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE PATCH TOPICAL 20120818 UNAPPROVED DRUG OTHER Two Hip Consulting, LLC CAPSAICIN; LIDOCAINE; MENTHOL; METHYL SALICYLATE .0175; .25; 2.5; 10 g/1; g/1; g/1; g/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 76074-251_ee7718be-f13c-4c98-b2bb-1490019c6827 76074-251 HUMAN PRESCRIPTION DRUG MEDI-FLEXX RX JOINT SUPPORT FORMULA GLUCOSAMINE SULFATE CHONDROITIN SULFATE (BOVINE) DIMETHYL SULFONE TABLET ORAL 20141205 UNAPPROVED DRUG OTHER Two Hip Consulting, LLC CHONDROITIN SULFATE (CHICKEN); DIMETHYL SULFONE; GLUCOSAMINE SULFATE 400; 200; 500 mg/1; mg/1; mg/1 76074-351_42590fa2-771c-417c-b548-9aad72118b30 76074-351 HUMAN PRESCRIPTION DRUG MEDI-LAXX RX STOOL SOFTENER AND LAXATIVE DOCUSATE SODIUM SENNOSIDES TABLET ORAL 20141205 UNAPPROVED DRUG OTHER Two Hip Consulting, LLC DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 76074-451_981517b9-9964-41a1-9bdf-83204ca2870e 76074-451 HUMAN PRESCRIPTION DRUG MEDI-DOZE RX SLEEP AID MELATONIN .GAMMA.-AMINOBUTYRIC ACID VALERIAN TABLET ORAL 20130220 UNAPPROVED DRUG OTHER Two Hip Consulting, LLC .GAMMA.-AMINOBUTYRIC ACID; MELATONIN; VALERIAN 30; 6; 50 mg/1; mg/1; mg/1 76075-101_e86af1ff-4109-4ef2-815c-7491d37987f5 76075-101 HUMAN PRESCRIPTION DRUG KYPROLIS carfilzomib INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120720 NDA NDA202714 Onyx Pharmaceuticals, Inc. CARFILZOMIB 60 mg/30mL Proteasome Inhibitor [EPC],Proteasome Inhibitors [MoA] 76077-100_7889c1e5-b6bf-4e8f-bb70-a4f73ca9bbcc 76077-100 HUMAN OTC DRUG Novana Wash Perineal Skin Cleanser Benzethonium Chloride SOLUTION TOPICAL 20120404 OTC MONOGRAPH NOT FINAL part333E NOVANA MEDICAL LLC BENZETHONIUM CHLORIDE .001 mL/mL 76077-200_041a4d30-30e6-4049-b74e-32e7a6529250 76077-200 HUMAN OTC DRUG Novana Moisturizing Dimethicone CREAM TOPICAL 20120404 OTC MONOGRAPH FINAL part347 NOVANA MEDICAL LLC DIMETHICONE .02 mL/mL 76077-300_7dfb8b9c-ad7a-4ba9-bbc9-3e356fd002ae 76077-300 HUMAN OTC DRUG Novana Protect Barrier Zinc Oxide CREAM TOPICAL 20120404 OTC MONOGRAPH FINAL part352 NOVANA MEDICAL LLC ZINC OXIDE .12 mL/mL 76077-400_34463f8e-014f-4ad5-80b3-ad5542a541bd 76077-400 HUMAN OTC DRUG Novana Antifungal Barrier with Miconazole Miconazole Nitrate CREAM TOPICAL 20120404 OTC MONOGRAPH FINAL part333C Novana Medical, LLC MICONAZOLE NITRATE .02 mL/mL 76077-500_c0b20660-4e87-4171-9c70-b6192b224f2c 76077-500 HUMAN OTC DRUG Novana All-In-One One Step Perineal Dimethicone LOTION TOPICAL 20120404 OTC MONOGRAPH NOT FINAL part356 NOVANA MEDICAL LLC DIMETHICONE .02 mL/mL 76079-001_eb06bf7a-9d16-4dc8-b541-2867adf0ad36 76079-001 HUMAN OTC DRUG Steiro BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Bioblockade LLC BENZALKONIUM CHLORIDE .13 mL/100mL 76081-010_18a4c3f0-c2d2-4cae-9389-444ad9c83393 76081-010 HUMAN OTC DRUG DAMOAE THERAPY PYRITHIONE ZINC SHAMPOO CUTANEOUS 20100801 OTC MONOGRAPH FINAL part358H DUALLIFE CO., LTD. PYRITHIONE ZINC 3 g/300g 76081-020_ea25800d-87f4-4545-a28d-b9138f8b115e 76081-020 HUMAN OTC DRUG DAMOAE THERAPY TONIC SALICYLIC ACID SOLUTION TOPICAL 20110901 OTC MONOGRAPH FINAL part358H DUALLIFE CO., LTD. SALICYLIC ACID 2.4 mL/120mL 76082-210_18b72e5d-776e-4c60-b6cb-f66003f5e972 76082-210 HUMAN OTC DRUG NOURISHING hydrator AVOBENZONE, OCTINOXATE, and OXYBENZONE CREAM TOPICAL 20111024 OTC MONOGRAPH NOT FINAL part352 Precision Dermatology, Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .0224; .084; .0392 g/mL; g/mL; g/mL 76084-1001_0a3c59b4-be55-499e-a5f3-c755aa957ef2 76084-1001 HUMAN OTC DRUG Lancell hair loss prevention hair grower clean formula panthenol LIQUID TOPICAL 20110408 UNAPPROVED DRUG OTHER MICELLBio Co., Ltd BIOTIN; NIACINAMIDE; PANTHENOL; PYRITHIONE ZINC .0006; .003; .005; .021 mL/mL; mL/mL; mL/mL; mL/mL 76084-2001_f6198b38-314f-438e-9df3-bcd74bf21080 76084-2001 HUMAN OTC DRUG Lancell hair loss prevention hair grower tonic SALICYLIC ACID LIQUID TOPICAL 20100408 UNAPPROVED DRUG OTHER MICELLBio Co., Ltd NIACINAMIDE; SALICYLIC ACID .003; .005 mL/mL; mL/mL 76084-3001_ef3b1b6a-9976-4cc2-bdcf-c56e6798a988 76084-3001 HUMAN OTC DRUG Lancell Slimming lanthanum chloride GEL TOPICAL 20100819 UNAPPROVED DRUG OTHER MICELLBio Co., Ltd LANTHANUM; STYPOCAULON SCOPARIUM 2.5; 2 mL/100mL; mL/100mL 76088-100_41ef7380-304d-4f30-b28a-38d35f3a4733 76088-100 HUMAN OTC DRUG Invisible Solid Xtreme Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE STICK TOPICAL 20110302 OTC MONOGRAPH FINAL part350 King Import Warehouse ALUMINUM CHLOROHYDRATE 20 g/100g 76088-101_4517f0e1-10ec-4025-bd6c-6ab894ce06a9 76088-101 HUMAN OTC DRUG Silky Smooth Anti-Perspirant Deodorant Invisible Solid ALUMINUM CHLOROHYDRATE STICK TOPICAL 20110302 OTC MONOGRAPH FINAL part350 King Import Warehouse ALUMINUM CHLOROHYDRATE 20 g/100g 76088-200_70ea2053-c282-4798-9c44-b0250ef1e816 76088-200 HUMAN OTC DRUG Hand Antibacterial Premium TRICLOSAN SOAP TOPICAL 20110302 OTC MONOGRAPH NOT FINAL part333E King Import Warehouse TRICLOSAN .2 mL/100mL 76088-300_c650de35-a75a-405e-baee-911b54a6581e 76088-300 HUMAN OTC DRUG Instant Hand Sanitizer Original ALCOHOL LIQUID TOPICAL 20110302 OTC MONOGRAPH NOT FINAL part333E King Import Warehouse ALCOHOL 62 mL/100mL 76088-301_faaf8a92-a793-40ab-bde1-d45b4bd0f2de 76088-301 HUMAN OTC DRUG Instant Hand Sanitizer Original With Aloe Vera And Vitamin E ALCOHOL LIQUID TOPICAL 20110302 OTC MONOGRAPH NOT FINAL part333E King Import Warehouse ALCOHOL 62 mL/100mL 76091-001_cfb1e46a-6a5a-40cd-ab80-0507876f5003 76091-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20020101 UNAPPROVED MEDICAL GAS Isis Medical, Inc. OXYGEN 99 L/100L 76092-101_fd8d9ad8-bfeb-49b9-90e7-37cf335a8cb5 76092-101 HUMAN OTC DRUG SMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM Camphor, Menthol, Methyl Salicylate PATCH TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part348 M J Winston International Ltd.. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 1.2; 5.7; 6.3 mg/1; mg/1; mg/1 76095-001_1eacda2f-5b58-4bbf-b2ce-12a9a9c232f6 76095-001 HUMAN OTC DRUG head and shoulders dandruff moisturizing action pyrithione zinc SHAMPOO TOPICAL 20110630 OTC MONOGRAPH FINAL part358H Midway Importing PYRITHIONE ZINC 1 mL/100mL 76095-003_787d7c39-0475-4499-bb2d-d8baca56d1ef 76095-003 HUMAN OTC DRUG Sedalmex Pain Reliever acetaminophen and caffeine TABLET ORAL 20110815 OTC MONOGRAPH NOT FINAL part343 Midway Importing, Inc ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 76095-100_6431ef64-58eb-4968-bae4-e8defbd4cd47 76095-100 HUMAN OTC DRUG CALCID ANTACID CALCIUM SUPPLEMENT REGULAR STRENGTH Calcium carbonate TABLET, CHEWABLE ORAL 20111230 OTC MONOGRAPH FINAL part331 Midway Importing CALCIUM CARBONATE 500 mg/1 76095-101_e7f7e6af-a4fc-4201-a9ca-0fd2fc59fd25 76095-101 HUMAN OTC DRUG CALCID ANTACID CALCIUM SUPPLEMENT REGULAR STRENGTH Calcium carbonate TABLET, CHEWABLE ORAL 20111230 OTC MONOGRAPH FINAL part331 Midway Importing CALCIUM CARBONATE 500 mg/1 76097-002_4e719a24-3424-4404-8416-852b7346d6ab 76097-002 HUMAN OTC DRUG Pollen Guard Grass Mix Grass Pollen Hay Fever Symptom Relief Anthoxanthum odaratum LIQUID ORAL 20111003 UNAPPROVED HOMEOPATHIC Western Allergy Services Ltd. ANTHOXANTHUM ODORATUM 1 [hp_X]/5mL 76097-003_a57dc676-bf56-4bd3-a285-5d81c3366213 76097-003 HUMAN OTC DRUG Pollen Guard Ragweed Ragweed Hay Fever Symptom Relief Ambrosia Artemisiaefolia LIQUID ORAL 20111003 UNAPPROVED HOMEOPATHIC Western Allergy Services Ltd. AMBROSIA ARTEMISIIFOLIA 1 [hp_X]/5mL 76097-004_a29d8b34-e132-4a33-8315-0c29c2882ffb 76097-004 HUMAN OTC DRUG Pollen Guard Weed Mix Weed Pollen Hay Fever Symptom Relief Plantago lanceolata LIQUID ORAL 20111003 UNAPPROVED HOMEOPATHIC Western Allergy Services Ltd. PLANTAGO LANCEOLATA POLLEN 1 [hp_X]/5mL 76102-100_54f80007-44ed-4d40-a192-22c69db117a9 76102-100 HUMAN OTC DRUG Bakers Best Arthritis Pain Relief METHYL SALICYLATE, MENTHOL, LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part348 Baker's Best LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE 1; 2.5; 4.5 g/100g; g/100g; g/100g 76103-004_ba07fb8f-073f-4f5c-8961-3ba2877971a1 76103-004 HUMAN OTC DRUG Correct Dose Childrens Allergy Relief Diphenhydramine Hydrochloride LIQUID ORAL 20110615 OTC MONOGRAPH FINAL part341 BFS Pharma, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 76105-479_b61ebcf6-dc18-493f-a569-492d30dbf4ca 76105-479 HUMAN OTC DRUG Eco SPF 30 Zinc Oxide LOTION TOPICAL 20110322 OTC MONOGRAPH FINAL part346 Eco Skin Care ZINC OXIDE 22 g/100g 76105-525_61881ec0-07c6-4007-b445-1ed41851f5b5 76105-525 HUMAN OTC DRUG SPF 30 Face Zinc Oxide LOTION TOPICAL 20110322 OTC MONOGRAPH FINAL part346 Eco Skin Care ZINC OXIDE 20 g/100g 76105-714_90b164dc-7c5b-4df1-9ca9-3d08569c7cf7 76105-714 HUMAN OTC DRUG All Natural Suncreen Zinc Oxide LOTION TOPICAL 20110322 OTC MONOGRAPH FINAL part346 Eco Skin Care ZINC OXIDE 22.5 g/100g 76113-012_6123be18-1ee6-46bd-994e-f44b57b4cea4 76113-012 HUMAN OTC DRUG American Infection Control Antiseptic Hand Wipes Alcohol CLOTH TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333E American Infection Control, Inc. ALCOHOL .62 mL/mL 76113-012_f7f20fc3-e0d0-4954-ac59-208ea984d55f 76113-012 HUMAN OTC DRUG American Infection Control Antiseptic Hand Wipes Alcohol CLOTH TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333E American Infection Control, Inc. ALCOHOL .62 mL/mL 76113-112_d2a4d18d-8a38-498f-8cb9-f0bd8a76cd74 76113-112 HUMAN OTC DRUG American Infection Control Antiseptic Body Wipes Alcohol CLOTH TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333E American Infection Control, Inc. ALCOHOL .62 mL/mL 76116-100_1d35322c-192f-4926-86d2-21720ec7b06a 76116-100 HUMAN OTC DRUG first depHense Alcohol-Free Antiseptic Foam Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20110113 OTC MONOGRAPH FINAL part333E First Dephense, LLC BENZALKONIUM CHLORIDE .13 mL/100mL 76117-001_a2362d50-4bb2-4ec9-864a-791a378618ad 76117-001 HUMAN OTC DRUG Rycontuss Cherry Flavor CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20110531 OTC MONOGRAPH FINAL part341 Okendpharma, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/5mL; mg/5mL; mg/5mL 76119-1170_543156d2-2004-4809-9fda-72fa8979d1e4 76119-1170 HUMAN OTC DRUG mally Perfect Prep Poreless Primer Avobenzone, Octinoxate CREAM TOPICAL 20120329 OTC MONOGRAPH FINAL part352 MallyGirl, LLC AVOBENZONE; OCTINOXATE .6; 2.25 g/30mL; g/30mL 76119-1211_e0928ce5-dca2-4604-b119-4cb78b6a9711 76119-1211 HUMAN OTC DRUG mally Poreless Perfection Glowing Foundation Fair OCTINOXATE, OXYBENZONE, ZINC OXIDE, TITANIUM DIOXIDE POWDER TOPICAL 20110317 OTC MONOGRAPH NOT FINAL part352 MallyGirl, LLC OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 2.5; .8; 7.5; 5 g/100g; g/100g; g/100g; g/100g 76119-1212_267f6706-d233-431e-984a-7f7b573d32b0 76119-1212 HUMAN OTC DRUG mally Poreless Perfection Glowing Foundation Light OCTINOXATE, OXYBENZONE, ZINC OXIDE, TITANIUM DIOXIDE POWDER TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part352 MallyGirl, LLC OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 2.5; .8; 7.5; 5 g/100g; g/100g; g/100g; g/100g 76119-1213_f7d8acda-cd9a-4ef9-979c-0d860a87c841 76119-1213 HUMAN OTC DRUG mally Poreless Perfection Glowing Foundation Medium OCTINOXATE, OXYBENZONE, ZINC OXIDE, TITANIUM DIOXIDE POWDER TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part352 MallyGirl, LLC OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 2.5; .8; 7.5; 5 g/100g; g/100g; g/100g; g/100g 76119-1214_0c6d3a63-0d87-4039-8d43-2f7afa1abf2e 76119-1214 HUMAN OTC DRUG mally Poreless Perfection Glowing Foundation Tan OCTINOXATE, OXYBENZONE, ZINC OXIDE, TITANIUM DIOXIDE POWDER TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part352 MallyGirl, LLC OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 2.5; .8; 7.5; 5 g/100g; g/100g; g/100g; g/100g 76119-1215_65e35c36-a54f-4c33-9dfb-c5121c78f133 76119-1215 HUMAN OTC DRUG mally Poreless Perfection Glowing Foundation Rich OCTINOXATE, OXYBENZONE, ZINC OXIDE, TITANIUM DIOXIDE POWDER TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part352 MallyGirl, LLC OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 2.5; .8; 7.5; 5 g/100g; g/100g; g/100g; g/100g 76119-1325_3014331a-7f13-41cf-9e3e-44113e5a2f47 76119-1325 HUMAN OTC DRUG mally Face Defender Foundation TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120329 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mL/53.2mL; mL/53.2mL 76119-1326_2e9c2b9a-aee8-4e18-9ffe-afc1db4ca10b 76119-1326 HUMAN OTC DRUG mally Face Defender Foundation TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120329 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mL/53.2mL; mL/53.2mL 76119-1327_6134846b-37d8-4411-a683-0ba9ca8698a1 76119-1327 HUMAN OTC DRUG mally Face Defender Foundation TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120329 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mL/53.2mL; mL/53.2mL 76119-1328_9e518ddf-9ed6-49e0-94dd-d22e96f3c97f 76119-1328 HUMAN OTC DRUG mally Face Defender Foundation TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120329 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mL/53.2mL; mL/53.2mL 76119-1329_cec26507-b11c-404c-b56b-ba4486090366 76119-1329 HUMAN OTC DRUG mally Face Defender Foundation TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120329 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mL/53.2mL; mL/53.2mL 76119-1440_debb8c13-91aa-4ed0-9c93-ce2bad2239ff 76119-1440 HUMAN OTC DRUG mally Face Defender Foundation BB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140203 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mg/53.2mL; mg/53.2mL 76119-1441_040b1272-ddd6-47fd-9a67-bf001c5635f0 76119-1441 HUMAN OTC DRUG mally Face Defender Foundation BB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140203 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mg/53.2mL; mg/53.2mL 76119-1442_6344cef0-4ce2-4343-86ce-beb371a77aab 76119-1442 HUMAN OTC DRUG mally Face Defender Foundation BB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140203 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mg/53.2mL; mg/53.2mL 76119-1443_f43df4fb-f834-4d53-af7c-50939b9a8dd3 76119-1443 HUMAN OTC DRUG mally Face Defender Foundation BB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140203 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mg/53.2mL; mg/53.2mL 76119-1444_20855b84-ad10-4599-aaa7-c3220e103d27 76119-1444 HUMAN OTC DRUG mally Face Defender Foundation BB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140203 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mg/53.2mL; mg/53.2mL 76119-1445_a65b3ae4-8b1c-4a87-b4cc-9529c1ea8d3f 76119-1445 HUMAN OTC DRUG mally Face Defender Foundation BB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140203 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mg/53.2mL; mg/53.2mL 76119-1446_b361e96a-6d3a-4673-9eaf-0f5f61426169 76119-1446 HUMAN OTC DRUG mally Face Defender Foundation BB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140203 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mg/53.2mL; mg/53.2mL 76119-1447_49b91377-dd77-4cd8-b09e-a055e74a8460 76119-1447 HUMAN OTC DRUG mally Face Defender Foundation BB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140203 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mg/53.2mL; mg/53.2mL 76119-5305_e0107e7b-3575-471e-a011-5869c6a0d874 76119-5305 HUMAN OTC DRUG mally Lip Defender AVOBENZONE, OCTINOXATE GEL TOPICAL 20120501 OTC MONOGRAPH FINAL part352 MallyGirl, LLC AVOBENZONE; OCTINOXATE .07; .245 g/3.5g; g/3.5g 76119-5306_42aacbf3-7841-44f2-9d06-3601138aa376 76119-5306 HUMAN OTC DRUG mally Lip Defender AVOBENZONE, OCTINOXATE GEL TOPICAL 20120501 OTC MONOGRAPH FINAL part352 MallyGirl, LLC AVOBENZONE; OCTINOXATE .07; .245 g/3.5g; g/3.5g 76119-5307_edc9dc16-4785-4116-8c9e-061a0e0dbb17 76119-5307 HUMAN OTC DRUG mally Lip Defender AVOBENZONE, OCTINOXATE GEL TOPICAL 20120501 OTC MONOGRAPH FINAL part352 MallyGirl, LLC AVOBENZONE; OCTINOXATE .07; .245 g/3.5g; g/3.5g 76119-5308_f8f7e779-29ae-47f5-b3e9-9da1bfafac7b 76119-5308 HUMAN OTC DRUG mally Lip Defender AVOBENZONE, OCTINOXATE GEL TOPICAL 20120501 OTC MONOGRAPH FINAL part352 MallyGirl, LLC AVOBENZONE; OCTINOXATE .07; .245 g/3.5g; g/3.5g 76119-5309_9ae7fca0-2500-40f1-b5d9-0651c56176be 76119-5309 HUMAN OTC DRUG mally Lip Defender AVOBENZONE, OCTINOXATE GEL TOPICAL 20120501 OTC MONOGRAPH FINAL part352 MallyGirl, LLC AVOBENZONE; OCTINOXATE .07; .245 g/3.5g; g/3.5g 76119-5310_8fbc79be-ea92-486f-a37e-a5c52ed11b9f 76119-5310 HUMAN OTC DRUG mally Lip Defender AVOBENZONE, OCTINOXATE GEL TOPICAL 20120501 OTC MONOGRAPH FINAL part352 MallyGirl, LLC AVOBENZONE; OCTINOXATE .07; .245 g/3.5g; g/3.5g 76123-120_7467de37-c515-4756-95c4-208e2619a0dc 76123-120 HUMAN OTC DRUG Alcohol Isopropyl Alcohol SWAB TOPICAL 20110405 OTC MONOGRAPH FINAL part344 School Health Corporation ISOPROPYL ALCOHOL .7 mL/mL 76123-121_274e5756-531b-4605-8186-b659f30d747d 76123-121 HUMAN OTC DRUG School Health Sterile Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20120503 OTC MONOGRAPH FINAL part344 School Health Corporation ISOPROPYL ALCOHOL .7 mL/mL 76123-243_291e65e5-2e47-4a7f-8797-896c5c4001be 76123-243 HUMAN OTC DRUG BZK Cleansing Benzalkonium Chloride SWAB TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333A School Health Corporation BENZALKONIUM CHLORIDE 1 mL/750mL 76123-245_1032a9d1-e6f3-4722-845f-b011f451b0c7 76123-245 HUMAN OTC DRUG BZK Antiseptic Benzalkonium Chloride SWAB TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333A School Health Corporation BENZALKONIUM CHLORIDE 1 mL/750mL 76125-250_438b89e3-ce40-9212-a9bd-212037e7c678 76125-250 PLASMA DERIVATIVE Koate -DVI Antihemophilic Factor (Human) KIT 19990520 BLA BLA101130 KEDRION BIOPHARMA, INC 76125-667_438b89e3-ce40-9212-a9bd-212037e7c678 76125-667 PLASMA DERIVATIVE Koate -DVI Antihemophilic Factor (Human) KIT 19990520 BLA BLA101130 KEDRION BIOPHARMA, INC 76125-783_ccc03011-5f48-5501-a38e-315a24fb45c7 76125-783 PLASMA DERIVATIVE Albuked Albumin (Human) SOLUTION INTRAVENOUS 19810728 BLA BLA101138 KEDRION BIOPHARMA, INC ALBUMIN (HUMAN) 10 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 76125-784_0e0fa161-4ed0-6026-5756-69e801ba44ee 76125-784 PLASMA DERIVATIVE Albuked Albumin (Human) SOLUTION INTRAVENOUS 19421021 BLA BLA101138 KEDRION BIOPHARMA, INC ALBUMIN (HUMAN) 5 g/20mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 76125-785_637f3098-8b1f-6b86-a3fa-6fc7cc757e61 76125-785 PLASMA DERIVATIVE Albuked Albumin (Human) SOLUTION INTRAVENOUS 19760826 BLA BLA101138 KEDRION BIOPHARMA, INC ALBUMIN (HUMAN) 2.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 76125-790_aebdf4b8-36e9-3de1-6370-52437b86838b 76125-790 PLASMA DERIVATIVE Albuked Albumin (Human) SOLUTION INTRAVENOUS 19760826 BLA BLA101138 KEDRION BIOPHARMA, INC ALBUMIN (HUMAN) 2.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 76125-791_928c48d7-6fcc-e467-a75b-e681e1900549 76125-791 PLASMA DERIVATIVE Albuked Albumin (Human) SOLUTION INTRAVENOUS 19810728 BLA BLA101138 KEDRION BIOPHARMA, INC ALBUMIN (HUMAN) 10 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 76125-792_61e9e171-3137-8907-ce13-3cb762885cef 76125-792 PLASMA DERIVATIVE Albuked Albumin (Human) SOLUTION INTRAVENOUS 19421021 BLA BLA101138 KEDRION BIOPHARMA, INC ALBUMIN (HUMAN) 5 g/20mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 76125-900_6eea2e64-5873-74bf-7785-aa7efad2ac2f 76125-900 PLASMA DERIVATIVE GAMMAKED Human Immunoglobulin G INJECTION INTRAVENOUS 20101013 BLA BLA125046 KEDRION BIOPHARMA, INC HUMAN IMMUNOGLOBULIN G 10 g/100mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] 76126-007_ef4b039e-11a4-423d-81b7-54c1fff48983 76126-007 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130107 ANDA ANDA091068 AGILA SPECIALTIES PRIVATE LIMITED CEFTRIAXONE SODIUM 10 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 76126-026_31c117c6-b0d5-449b-9bb3-06b008b18a2b 76126-026 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140410 ANDA ANDA201025 AGILA SPECIALTIES PRIVATE LIMITED AMPICILLIN SODIUM 250 mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 76126-027_31c117c6-b0d5-449b-9bb3-06b008b18a2b 76126-027 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140410 ANDA ANDA201025 AGILA SPECIALTIES PRIVATE LIMITED AMPICILLIN SODIUM 500 mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 76126-028_31c117c6-b0d5-449b-9bb3-06b008b18a2b 76126-028 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140410 ANDA ANDA201025 AGILA SPECIALTIES PRIVATE LIMITED AMPICILLIN SODIUM 1 g/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 76126-035_ded105f4-19b2-4f6e-a601-16dd87b81c68 76126-035 HUMAN PRESCRIPTION DRUG Ampicillin Sodium and Sulbactam Sodium Ampicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140408 ANDA ANDA201024 AGILA SPECIALTIES PRIVATE LIMITED AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/3g; g/3g Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 76126-041_46607aef-bb2a-4d9f-ae4a-12815571dc36 76126-041 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION INFILTRATION; INTRAVENOUS 20140412 ANDA ANDA202242 AGILA SPECIALTIES PRIVATE LIMITED LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 76126-047_31c117c6-b0d5-449b-9bb3-06b008b18a2b 76126-047 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140410 ANDA ANDA201025 AGILA SPECIALTIES PRIVATE LIMITED AMPICILLIN SODIUM 2 g/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 76126-049_c33a167d-7e89-4dce-857f-ef141b9a80e7 76126-049 HUMAN PRESCRIPTION DRUG Ampicillin Sodium and Sulbactam Sodium Ampicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140408 ANDA ANDA202197 AGILA SPECIALTIES PRIVATE LIMITED AMPICILLIN SODIUM; SULBACTAM SODIUM 10; 5 g/15g; g/15g Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 76126-050_bc7d766c-448d-4382-8eca-c34bd1684c6f 76126-050 HUMAN PRESCRIPTION DRUG Ampicillin Sodium Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140408 ANDA ANDA202198 AGILA SPECIALTIES PRIVATE LIMITED AMPICILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 76126-072_9ef3da7e-bc38-46ee-b200-b317406495ba 76126-072 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan INJECTION SUBCUTANEOUS 20140415 ANDA ANDA203322 AGILA SPECIALTIES PRIVATE LIMITED SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] 76126-075_f9dac281-857e-4566-a76e-63fba4298dcc 76126-075 HUMAN PRESCRIPTION DRUG mesna mesna INJECTION, SOLUTION INTRAVENOUS 20140719 ANDA ANDA203364 AGILA SPECIALTIES PRIVATE LIMITED MESNA 100 mg/mL Cytoprotective Agent [EPC] 76126-100_9e6b3906-502d-4e2f-a393-8c1842e9d61e 76126-100 HUMAN PRESCRIPTION DRUG oxacillin oxacillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140826 ANDA ANDA091486 AGILA SPECIALTIES PRIVATE LIMITED OXACILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 76126-101_9e6b3906-502d-4e2f-a393-8c1842e9d61e 76126-101 HUMAN PRESCRIPTION DRUG oxacillin oxacillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140826 ANDA ANDA091486 AGILA SPECIALTIES PRIVATE LIMITED OXACILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 76126-104_134ef680-fb89-4b71-b7fa-4406457c5524 76126-104 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20140322 ANDA ANDA078640 AGILA SPECIALTIES PRIVATE LIMITED ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] 76126-202_888ad933-52a4-4d4d-91e9-bb8908ab7770 76126-202 HUMAN PRESCRIPTION DRUG Ketorolac tromethamine Ketorolac tromethamine INJECTION INTRAMUSCULAR; INTRAVENOUS 20140805 ANDA ANDA201155 AGILA SPECIALTIES PRIVATE LIMITED KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 76126-203_888ad933-52a4-4d4d-91e9-bb8908ab7770 76126-203 HUMAN PRESCRIPTION DRUG Ketorolac tromethamine Ketorolac tromethamine INJECTION INTRAMUSCULAR; INTRAVENOUS 20140805 ANDA ANDA201155 AGILA SPECIALTIES PRIVATE LIMITED KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 76126-204_888ad933-52a4-4d4d-91e9-bb8908ab7770 76126-204 HUMAN PRESCRIPTION DRUG Ketorolac tromethamine Ketorolac tromethamine INJECTION INTRAMUSCULAR 20140805 ANDA ANDA201155 AGILA SPECIALTIES PRIVATE LIMITED KETOROLAC TROMETHAMINE 60 mg/2mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 76126-273_ded105f4-19b2-4f6e-a601-16dd87b81c68 76126-273 HUMAN PRESCRIPTION DRUG Ampicillin Sodium and Sulbactam Sodium Ampicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140408 ANDA ANDA201024 AGILA SPECIALTIES PRIVATE LIMITED AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1.5g; g/1.5g Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] 76126-290_e729c612-2212-48c1-b510-359e3f5e0a84 76126-290 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110702 ANDA ANDA091469 AGILA SPECIALTIES PRIVATE LIMITED VANCOMYCIN HYDROCHLORIDE 10 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] 76128-155_c91fc19e-03f7-4b91-8158-343cd07762fa 76128-155 HUMAN PRESCRIPTION DRUG PHOTOFRIN porfimer sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19951227 NDA NDA020451 Pinnacle Biologics, Inc. PORFIMER SODIUM 75 mg/31.8mL Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE] 76134-1111_76fa163e-73dd-4e91-8167-9cadf685d05c 76134-1111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333E Stericycle, Inc. ALCOHOL 665 mL/L 76138-001_1b91ac3e-2ded-413a-8293-0e1a1101ed36 76138-001 HUMAN OTC DRUG Antiseptic Hand Sanitizer Alcohol GEL TOPICAL 20110327 OTC MONOGRAPH NOT FINAL part333A Innovation Specialties ALCOHOL 36.58 mL/59mL 76138-101_ab0543ac-4b29-4c6e-94e6-265864c1d815 76138-101 HUMAN OTC DRUG Hand Sanitizer Alcohol SPRAY TOPICAL 20100505 OTC MONOGRAPH NOT FINAL part333A INNOVATION SPECIALTIES ALCOHOL 62 mL/100mL 76138-102_bf4238dc-fd42-446b-9f44-84f7f5a005e8 76138-102 HUMAN OTC DRUG Credit Card Shape Hand Sanitizer Alcohol SPRAY TOPICAL 20100505 OTC MONOGRAPH NOT FINAL part333A INNOVATION SPECIALTIES ALCOHOL 62 mL/100mL 76138-103_d81bea62-cd01-4dd7-bac4-4b16269186ec 76138-103 HUMAN OTC DRUG Compact Hand Sanitizer Alcohol GEL TOPICAL 20100505 OTC MONOGRAPH NOT FINAL part333A INNOVATION SPECIALTIES ALCOHOL 62 mL/100mL 76138-104_303a11ff-8301-49d3-87a7-d5c03932feec 76138-104 HUMAN OTC DRUG Hand Sanitizer w/Carabiner Alcohol GEL TOPICAL 20100505 OTC MONOGRAPH NOT FINAL part333A INNOVATION SPECIALTIES ALCOHOL 62 mL/100mL 76138-106_0acdc0af-86b0-47f1-854d-735f33eb18c9 76138-106 HUMAN OTC DRUG Compact Hand Sanitizer Alcohol GEL TOPICAL 20080505 OTC MONOGRAPH NOT FINAL part333A INNOVATION SPECIALTIES ALCOHOL 62 mL/100mL 76138-107_2f21302c-99ae-448b-ba10-53fe62cc1594 76138-107 HUMAN OTC DRUG Hand Sanitizer bottle with carabiner Alcohol LIQUID TOPICAL 20080505 OTC MONOGRAPH NOT FINAL part333A INNOVATION SPECIALTIES ALCOHOL 62 mL/100mL 76138-107_e142fcad-0cf3-48fb-92fd-a342fe55eec7 76138-107 HUMAN OTC DRUG Hand Sanitizer bottle with carabiner Alcohol LIQUID TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333A INNOVATION SPECIALTIES ALCOHOL 62 mL/100mL 76138-111_9e970965-ca83-483a-a173-a000ff027637 76138-111 HUMAN OTC DRUG Antibacterial Hand Sanitizer Ethyl alcohol SPRAY TOPICAL 20140710 OTC MONOGRAPH NOT FINAL part333A Innovation Specialties ALCOHOL 62 mL/100mL 76138-111_d04669af-5e5c-444b-845b-70517ce382d8 76138-111 HUMAN OTC DRUG Antibacterial Hand Sanitizer Ethyl alcohol SPRAY TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part333A Innovation Specialties ALCOHOL 62 mL/100mL 76138-201_aafeca9c-6b43-443e-b22c-26e2a6436407 76138-201 HUMAN OTC DRUG SPF 30 Sunscreen Tottle AVOBENZONE, OXYBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 INNOVATION SPECIALTIES AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 1; 5; 7.5; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 76138-202_3ceedd56-d024-40d7-9df3-6398035dcc46 76138-202 HUMAN OTC DRUG SPF 30 Sunscreen Tottle w Carabiner AVOBENZONE, OXYBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part352 INNOVATION SPECIALTIES AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 1; 5; 7.5; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 76138-203_7a2b3590-021b-4796-9a8d-ad22703146cb 76138-203 HUMAN OTC DRUG SPF 30 Sunscreen OCTINOXATE, OXYBENZONE, OCTISALATE LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 INNOVATION SPECIALTIES OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 1; 4 g/100mL; g/100mL; g/100mL 76138-204_43aa6fc2-8ea9-4795-8885-b3da02eee2bb 76138-204 HUMAN OTC DRUG SPF 30 Sunscreen Octinoxate, Oxybenzone, Octisalate, Titanium Dioxide LOTION TOPICAL 20130605 OTC MONOGRAPH NOT FINAL part352 INNOVATION SPECIALTIES OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 2; 4; 2.5 mg/mL; mg/mL; mg/mL; mg/mL 76140-105_c89c0e5d-c78a-41b2-84b6-33a32ffbb403 76140-105 HUMAN OTC DRUG Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride LIQUID ORAL 20130410 OTC MONOGRAPH FINAL part341 davAgen Pharmaceutical, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL 76140-106_0e6409bc-15a7-4d73-b4de-3952e31cb7f3 76140-106 HUMAN OTC DRUG Tussin DM Dextromethorphan Hydrobromide and Guaifenesin LIQUID ORAL 20130410 OTC MONOGRAPH FINAL part341 davAgen Pharmaceutical, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 76141-368_e031f411-f6af-4130-b693-50a5da636514 76141-368 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20080820 ANDA ANDA074661 Maximino Import NAPROXEN SODIUM 220 mg/1 76144-000_e6869df4-86ae-42e1-b312-ce2c24baea9f 76144-000 HUMAN OTC DRUG PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20130411 OTC MONOGRAPH NOT FINAL part352 Paula's Choice, Inc TITANIUM DIOXIDE; ZINC OXIDE 23.2; 60 mg/mL; mg/mL 76147-123_eb73028a-b80b-4adb-a269-f8d102506cd4 76147-123 HUMAN OTC DRUG StriVectin-SH NIA-114 UVA UVB Shields SPF 30 HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20110406 OTC MONOGRAPH FINAL part352 StriVectin Operating Company Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.6; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 76151-105_83123704-1ed3-4704-bb15-dfdc300de784 76151-105 HUMAN OTC DRUG Oil-Free Daily Hydration SPF 15 OCTINOXATE, AVOBENZONE CREAM TOPICAL 20110416 OTC MONOGRAPH FINAL part352 Boscia LLC AVOBENZONE; OCTINOXATE 3; 5 mL/100mL; mL/100mL 76151-106_27253c3f-9774-4cd4-a130-44aeba6a6d35 76151-106 HUMAN OTC DRUG Boscia Daily Hydration SPF 15 Broad Spectrum For Normal To Oily Skin AVOBENZONE, OCTINOXATE CREAM TOPICAL 20121108 OTC MONOGRAPH FINAL part352 Boscia LLC AVOBENZONE; OCTINOXATE 30; 60 mg/mL; mg/mL 76151-207_b3cc5a9d-defc-47a5-8630-3cfc6b44aebf 76151-207 HUMAN OTC DRUG Restorative Day Moisture SPF 15 OCTINOXATE, AVOBENZONE CREAM TOPICAL 20110416 OTC MONOGRAPH FINAL part352 Boscia LLC AVOBENZONE; OCTINOXATE 3; 5 mL/100mL; mL/100mL 76151-210_975d9669-fc15-4026-8b39-f7b7d966b1e1 76151-210 HUMAN OTC DRUG Boscia BB SPF 27 PA TITANIUM DIOXIDE CREAM TOPICAL 20110511 OTC MONOGRAPH FINAL part352 Boscia LLC TITANIUM DIOXIDE 6.4 g/100g 76151-211_29ab97a6-8d80-44f5-8c78-fe58cc78ff5c 76151-211 HUMAN OTC DRUG Boscia BB Broad Spectrum SPF 27 PA Self Adjusting Shade TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20121107 OTC MONOGRAPH FINAL part352 Boscia LLC TITANIUM DIOXIDE; ZINC OXIDE 10.02; .97 g/100g; g/100g 76151-217_14a23c01-fbbd-4ad9-8829-4b4618c831ee 76151-217 HUMAN OTC DRUG Boscia Restorative Day Moisture Broad Spectrum SPF 15 For Dry Skin AVOBENZONE, OCTINOXATE CREAM TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 Boscia LLC AVOBENZONE; OCTINOXATE 30; 65 mg/mL; mg/mL 76151-221_779b02f7-b51b-43f0-8187-ccdab1ce5e8f 76151-221 HUMAN OTC DRUG Boscia BB BRONZE Broad Spectrum SPF 27 PA Self-Adjusting Shade TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20121107 OTC MONOGRAPH FINAL part352 Boscia LLC TITANIUM DIOXIDE; ZINC OXIDE 7.55; .98 g/100g; g/100g 76151-231_2c45d0fc-f946-4452-ac8e-fcb0cf6d4255 76151-231 HUMAN OTC DRUG Boscia B.B. LIGHT Broad Spectrum SPF 27 PA Self-Adjusting Shade TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20121106 OTC MONOGRAPH FINAL part352 Boscia LLC TITANIUM DIOXIDE; ZINC OXIDE 11.25; .98 g/100g; g/100g 76151-241_16209fb9-ca41-4820-809f-b845dbb772fc 76151-241 HUMAN OTC DRUG Boscia Daily Defense Sunscreen Broad Spectrum SPF 50 PA OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20121107 OTC MONOGRAPH FINAL part352 Boscia LLC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.25; 5.742; 4.75 g/100g; g/100g; g/100g 76151-251_6eeeb3f7-ebb9-4a2b-a08b-5f4a708cbab9 76151-251 HUMAN OTC DRUG Boscia Self-Defense Vital Antioxidant Moisture Broad Spectrum SPF 30 AVOBENZONE, OCTINOXATE CREAM TOPICAL 20121103 OTC MONOGRAPH FINAL part352 Boscia LLC AVOBENZONE; OCTINOXATE 30; 75 mg/mL; mg/mL 76151-261_e8b32518-712d-47e4-bb3b-f424b93283df 76151-261 HUMAN OTC DRUG Boscia All In One B.B. Eye Brightener Broad Spectrum SPF 20 TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Boscia LLC TITANIUM DIOXIDE 6.45 g/100g 76159-001_84374af4-c328-4bc7-987c-ddb2c027de69 76159-001 HUMAN OTC DRUG 3LAB PERFECT BB SPF 40 Broad Spectrum 01 TITANIUM DIOXIDE CREAM TOPICAL 20130110 OTC MONOGRAPH FINAL part352 3LAB, Inc TITANIUM DIOXIDE 121.6 mg/mL 76159-002_633a9c4a-6527-4794-9ed9-5c51fdf80eb7 76159-002 HUMAN OTC DRUG 3LAB PERFECT BB SPF 40 Broad Spectrum 02 TITANIUM DIOXIDE CREAM TOPICAL 20130110 OTC MONOGRAPH FINAL part352 3LAB, Inc TITANIUM DIOXIDE 121.6 mg/mL 76159-003_e6a36d6e-3a91-4d30-993e-182c406037a1 76159-003 HUMAN OTC DRUG 3LAB PERFECT BB SPF 40 Broad Spectrum 03 TITANIUM DIOXIDE CREAM TOPICAL 20130110 OTC MONOGRAPH FINAL part352 3LAB, Inc TITANIUM DIOXIDE 77.2 mg/mL 76159-004_da16efaf-dbca-481e-b594-9b8677968ff8 76159-004 HUMAN OTC DRUG 3LAB Aqua BB SPF 40 BROAD SPECTRUM 01 TITANIUM DIOXIDE CREAM TOPICAL 20131118 OTC MONOGRAPH NOT FINAL part352 3LAB, Inc. TITANIUM DIOXIDE 78.6 mg/mL 76159-005_314ce73c-4d8b-4ffb-8f14-8df268468faf 76159-005 HUMAN OTC DRUG 3LAB Aqua BB SPF 40 BROAD SPECTRUM 02 TITANIUM DIOXIDE CREAM TOPICAL 20131118 OTC MONOGRAPH NOT FINAL part352 3LAB, Inc. TITANIUM DIOXIDE 78.6 mg/mL 76159-006_d3536448-ece4-41db-9795-c4abbf4895a0 76159-006 HUMAN OTC DRUG 3LAB Aqua BB SPF 40 BROAD SPECTRUM 03 TITANIUM DIOXIDE CREAM TOPICAL 20131118 OTC MONOGRAPH NOT FINAL part352 3LAB, Inc. TITANIUM DIOXIDE 78.6 mg/mL 76159-124_83d7b0fa-f63d-4b3f-9b09-14bd918a4499 76159-124 HUMAN OTC DRUG 3LAB Hydra Day SPF 20 Broad Spectrum Water-Based Sunscreen OCTINOXATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20121015 OTC MONOGRAPH FINAL part352 3LAB, Inc AVOBENZONE; OCTINOXATE; OCTISALATE 2; 75; 46 mg/mL; mg/mL; mg/mL 76159-234_bfcebd50-7c6b-467f-a563-4b3c76ac06bb 76159-234 HUMAN OTC DRUG 3LAB PERFECT Lite Sunscreen SPF 30 Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110415 OTC MONOGRAPH FINAL part352 3LAB, Inc TITANIUM DIOXIDE; ZINC OXIDE 24.8; 60 mg/mL; mg/mL 76159-345_a95cbdf5-16b6-44b1-8c34-032c80019703 76159-345 HUMAN OTC DRUG 3LAB PERFECT Sunscreen SPF 50 Plus Broad Spectrum HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20110421 OTC MONOGRAPH FINAL part352 3LAB, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 26 mg/mL; mg/mL; mg/mL; mg/mL 76161-001_7e1fa295-a007-4597-a00c-58ab2f0f7e29 76161-001 HUMAN OTC DRUG Alcohol Prep ISOPROPYL ALCOHOL SWAB TOPICAL 20110420 OTC MONOGRAPH NOT FINAL part333A KYJ Medical Products Co.,Ltd. ISOPROPYL ALCOHOL .7 mL/1 76162-101_a9a4c1e7-d75b-4cda-b1f2-2fb3ae714095 76162-101 HUMAN OTC DRUG Antibacterial Antibacterial LIQUID TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333E Topco Associates LLC TRICLOSAN .476 mL/340mL 76162-102_a9a4c1e7-d75b-4cda-b1f2-2fb3ae714095 76162-102 HUMAN OTC DRUG Antibacterial Antibacterial LIQUID TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333E Topco Associates LLC TRICLOSAN .476 mL/340mL 76162-103_a9a4c1e7-d75b-4cda-b1f2-2fb3ae714095 76162-103 HUMAN OTC DRUG Antibacterial Antibacterial LIQUID TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333E Topco Associates LLC TRICLOSAN .476 mL/340mL 76162-809_0a96632e-984d-4503-82c9-16b2db07403f 76162-809 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20110713 OTC MONOGRAPH NOT FINAL part333A Topco Associates ISOPROPYL ALCOHOL 70 mL/100mL 76163-010_75e7420a-7f83-4fb4-b6a5-c242fecc0ba5 76163-010 HUMAN OTC DRUG DR.OH PATCH CAMPHOR (NATURAL) PATCH CUTANEOUS 20110201 OTC MONOGRAPH NOT FINAL part348 YEPHARM CAMPHOR (NATURAL); MENTHOL 28.4; 16 mg/2000mg; mg/2000mg 76166-001_2b8b55cf-347b-4675-bf90-ce0e67071052 76166-001 HUMAN OTC DRUG ELF Personal Blend Foundation SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 Shanghai Justking Enterprise Co. Ltd. TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; g/100g 76166-002_186327da-050b-4e68-ab44-e7ed34d29140 76166-002 HUMAN OTC DRUG ELF Mineral Moisturizing Lip Tint SPF 8 TITANIUM DIOXIDE POWDER TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 Shanghai Justking Enterprise Co. Ltd. TITANIUM DIOXIDE 4 g/100g 76167-001_1148ea39-fe60-4c27-bd40-181fd492fabf 76167-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 FLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION INTRAVENOUS 20141112 ANDA ANDA204385 Children's Hospital of Michigan FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 76167-002_c849e41b-ab04-4c4b-a055-57e87ce42915 76167-002 HUMAN PRESCRIPTION DRUG Sodium FluorideF 18 F 18 SODIUM FLUORIDE F-18 INJECTION INTRAVENOUS 20120612 UNAPPROVED DRUG OTHER Children's Hospital of Michigan SODIUM FLUORIDE F-18 200 mg/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 76167-003_248c7653-7014-48fd-98df-998225515102 76167-003 HUMAN PRESCRIPTION DRUG AmmoniaN 13 N 13 AMMONIA N-13 INJECTION INTRAVENOUS 20120130 UNAPPROVED DRUG OTHER Children's Hospital of Michigan AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 76168-009_5a83ea7c-214c-4a89-9e10-dede03f58db3 76168-009 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20110401 OTC MONOGRAPH NOT FINAL part343 Velocity Pharma ASPIRIN 81 mg/1 76168-010_b3795b58-f7b7-4a62-89c8-23d11e38f44c 76168-010 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20121205 OTC MONOGRAPH NOT FINAL part343 Velocity Pharma ACETAMINOPHEN 500 mg/1 76168-011_e0595668-bbee-4f87-92cb-2a987105d2c0 76168-011 HUMAN OTC DRUG Pain Relief PM Acetaminophen PM TABLET ORAL 20121205 OTC MONOGRAPH NOT FINAL part343 Velocity Pharma ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 76168-012_62377580-5148-43ee-936f-0624149301d7 76168-012 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20120701 ANDA ANDA091239 Velocity Pharma IBUPROFEN 200 mg/1 76168-013_4abf1358-6f58-4ef4-b467-03418e46a522 76168-013 HUMAN OTC DRUG Allergy Diphenhydramine Hydrochloride TABLET ORAL 20120512 OTC MONOGRAPH FINAL part341 Velocity Pharma DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 76168-021_240453b0-189a-401e-9f2e-2bf977f7aaa6 76168-021 HUMAN OTC DRUG Pain Reliever Fever Reducer Acetaminophen,Dextromethorphan hydrobromide,Phenylephrine Hydrochloride,Chlorpheniramine Maleate TABLET, EFFERVESCENT ORAL 20140815 OTC MONOGRAPH FINAL part341 Velocity Pharma ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 250; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 76168-055_b3bacaef-5dd7-4237-a327-ed4ee33274ee 76168-055 HUMAN OTC DRUG DayTime Cold and Flu Acetaminophen,Dextromethorphan,Phenylephrine CAPSULE, LIQUID FILLED ORAL 20140501 OTC MONOGRAPH FINAL part341 Velocity Pharma ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 76168-056_311d7647-9347-4548-8c4a-024b88d7b66a 76168-056 HUMAN OTC DRUG NightTime Cold and Flu Acetaminophen,Dextromethorphan,Doxylamine CAPSULE, LIQUID FILLED ORAL 20140501 OTC MONOGRAPH FINAL part341 Velocity Pharma ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 10; 6.25 mg/1; mg/1; mg/1 76168-057_f905bb92-063f-4b40-882d-f2e4514d8d8b 76168-057 HUMAN OTC DRUG DAYTIME NIGHTTIME COLD/FLU acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl KIT ORAL 20140715 OTC MONOGRAPH FINAL part341 Velocity Pharma 76168-064_1f5a9653-ad96-4723-8ec2-4e0815495c66 76168-064 HUMAN OTC DRUG Menstrual Relief Acetaminophen,Caffeine,Pyrilamine TABLET ORAL 20130501 OTC MONOGRAPH NOT FINAL part343 Velocity Pharma ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 76168-065_311b4f30-bb33-4664-bb63-f059c7bf6385 76168-065 HUMAN OTC DRUG Nightime Sleep Aid Diphenhydramine CAPSULE, LIQUID FILLED ORAL 20140331 OTC MONOGRAPH FINAL part341 Velocity Pharma DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 76168-066_3699cb9c-31a9-43ef-981a-0a35c910a0e4 76168-066 HUMAN OTC DRUG ZzzSleep Diphenhydramine CAPSULE, LIQUID FILLED ORAL 20131015 OTC MONOGRAPH FINAL part341 Velocity Pharma DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 76168-069_5d5cb3d5-4364-4980-93b0-c75f5c482601 76168-069 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20130401 OTC MONOGRAPH NOT FINAL part334 Velocity Pharma DOCUSATE SODIUM 100 mg/1 76169-101_4f8cbaac-2de0-46b8-90f4-7b38e2eed150 76169-101 HUMAN OTC DRUG Renewing Antioxidant Treatment SPF 6 GNLD International Octyl Methoxycinnamate, Avobenzone CREAM TOPICAL 20110422 OTC MONOGRAPH FINAL part352 GNLD International AVOBENZONE; OCTINOXATE 1.7; 6 g/100g; g/100g 76169-102_3cff951c-c569-48a9-9b08-1f057687465e 76169-102 HUMAN OTC DRUG Renewing Antioxidant Treatment SPF 6 GNLD International Avobenzone, Octyl Methoxycinnamate CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part352 GNLD International AVOBENZONE; OCTINOXATE 1.7; 6 g/100g; g/100g 76170-101_47fb2ea9-27da-2057-f277-834e1d982b01 76170-101 HUMAN OTC DRUG Dentree sodium fluoride GEL, DENTIFRICE DENTAL 20120401 OTC MONOGRAPH FINAL part355 e-soup Co., Ltd. SODIUM FLUORIDE .22 g/1000mL 76170-102_ad16ca7f-43be-bcfb-2aa3-87bd5d7f5fdf 76170-102 HUMAN OTC DRUG Dentree sodium fluoride GEL, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 e-soup Co., Ltd. SODIUM FLUORIDE .22 g/100mL 76170-103_1d0e5655-c373-06cd-d387-8a2e10d3a0fc 76170-103 HUMAN OTC DRUG Dentree sodium fluoride GEL, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 e-soup Co., Ltd. SODIUM FLUORIDE .22 g/100mL 76173-1001_7c58d52c-941e-4806-8348-388e1b92c62f 76173-1001 HUMAN OTC DRUG Rendrevie Sun Screen SPF35 PA OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20110720 OTC MONOGRAPH NOT FINAL part352 Cellinbio Co Ltd OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 5.625; 2.25; 3.89 mL/75mL; mL/75mL; mL/75mL 76173-1002_1aab8317-c273-439c-a159-f92e8f1d2f76 76173-1002 HUMAN OTC DRUG BONNOIR HAIR MEDI PYRITHIONE ZINC, PANTHENOL, NIACINAMIDE, BIOTIN SHAMPOO TOPICAL 20110727 UNAPPROVED DRUG OTHER Cellinbio Co Ltd BIOTIN; NIACINAMIDE; PANTHENOL; PYRITHIONE ZINC .21; 1.05; 1.75; 7.35 mL/350mL; mL/350mL; mL/350mL; mL/350mL 76173-1003_3eaf2422-e6e7-45ed-afbd-8dd677ce8e7e 76173-1003 HUMAN OTC DRUG Vita Fresh SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110727 OTC MONOGRAPH FINAL part355 Cellinbio Co Ltd SODIUM MONOFLUOROPHOSPHATE 1.125 g/150g 76173-1004_442dec39-3f85-4b5d-9fe9-fecc13372abb 76173-1004 HUMAN OTC DRUG The Cellin EOP B.B Cream TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE EMULSION TOPICAL 20110727 OTC MONOGRAPH NOT FINAL part352 Cellinbio Co Ltd OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; 2.556; .768 mL/40mL; mL/40mL; mL/40mL 76173-1005_fc97a0da-00cc-4efb-b6ec-7017df10d2d3 76173-1005 HUMAN OTC DRUG SUYAN CHUNGSOO ARBUTIN, GLYCERIN LIQUID TOPICAL 20111007 OTC MONOGRAPH FINAL part347 Cellinbio Co Ltd ARBUTIN; GLYCERIN .26; .26 mL/130mL; mL/130mL 76173-1006_9c2a55f2-eeb5-4280-a063-470b625c8371 76173-1006 HUMAN OTC DRUG SUYAN CHUNGSYU ARBUTIN, GLYCERIN EMULSION TOPICAL 20111108 OTC MONOGRAPH FINAL part347 Cellinbio Co Ltd ARBUTIN; GLYCERIN 2.6; 4.9 mL/130mL; mL/130mL 76173-1007_379cbc65-9c8a-4c51-80bc-f6458432c8ea 76173-1007 HUMAN OTC DRUG SUYAN JEONGBAEK GLYCERIN, ARBUTIN CREAM TOPICAL 20111109 OTC MONOGRAPH FINAL part347 Cellinbio Co Ltd ARBUTIN; GLYCERIN 1; 4.8 mL/50mL; mL/50mL 76173-1008_87edc4e4-ccea-4fd2-a258-5b2e5bbbf108 76173-1008 HUMAN OTC DRUG SUYAN JEONGDAN TEA TREE OIL SOAP TOPICAL 20111212 UNAPPROVED DRUG OTHER Cellinbio Co Ltd TEA TREE OIL .5 g/100g 76173-1100_568e8df7-60d0-4b07-966e-ec01a306507b 76173-1100 HUMAN OTC DRUG The Cellin SC BB Cream SPF 25 PA TITANIUM DIOXIDE CREAM TOPICAL 20130828 OTC MONOGRAPH NOT FINAL part352 Cellinbio Co Ltd OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 6.39; 1.92 g/30g; g/30g; g/30g 76173-1101_cc4a811c-1c63-47a8-80bb-3fd5d02b9c88 76173-1101 HUMAN OTC DRUG THE CELLIN SUN SCREEN SPF35 PA PLUS PLUS Octinoxate, Titanium Dioxide, Octisalate CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 Cellinbio Co Ltd OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 5.62; 2.25; 3.89 mg/75mL; mg/75mL; mg/75mL 76174-100_e903affc-b833-4294-ab5c-0d4b11d135ea 76174-100 HUMAN OTC DRUG Scape SPF 50 Athlete Sunblock AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20110422 OTC MONOGRAPH FINAL part352 Nupur Formulations Inc AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 6; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL 76174-110_3f6fcaf8-0226-4391-b58c-200b79ff9cb1 76174-110 HUMAN OTC DRUG Scape SPF 30 Athlete Sunblock AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20110422 OTC MONOGRAPH FINAL part352 Nupur Formulations Inc AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 6; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL 76174-120_b567e06e-965a-45c7-974c-10ff1c9b11e4 76174-120 HUMAN OTC DRUG 2X Sunblock SPF 50 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE LIQUID TOPICAL 20110422 OTC MONOGRAPH FINAL part352 Nupur Formulations Inc AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 6; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL 76174-130_c7b93248-4907-4add-887e-b606a0a0e217 76174-130 HUMAN OTC DRUG Scape SPF 50 Moisturizing Face AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20110422 OTC MONOGRAPH FINAL part352 Nupur Formulations Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 6; 6 g/100g; g/100g; g/100g; g/100g; g/100g 76174-140_518c5edb-652c-4695-9097-7524edcab3fd 76174-140 HUMAN OTC DRUG SCAPE SPF 30 LIP BALM AVOBENZONE, OCTINOXATE, OCTISALATE,OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20110427 OTC MONOGRAPH FINAL part352 Nupur Formulations Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 7.5; 5; 6; 5 g/100g; g/100g; g/100g; g/100g; g/100g 76176-003_582ae543-a5f2-4fad-9cee-765ef78d507a 76176-003 HUMAN OTC DRUG SANITAXE HAND SANITIZER LIQUID TOPICAL 20140731 OTC MONOGRAPH NOT FINAL part333A NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD ALCOHOL 62 mL/100mL 76176-017_b1b6f9cd-d97f-4788-a761-8bc0a9e2ccf6 76176-017 HUMAN OTC DRUG PHARMACYS PRESCRIPTION ANALGESIC GEL TOPICAL 20140101 OTC MONOGRAPH FINAL part346 NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD MENTHOL 1 g/100g 76176-018_d26db1fe-d788-4175-b933-dc4cb597fb3c 76176-018 HUMAN OTC DRUG PHARMACYS PRESCRIPTION VAPOR RUB GEL TOPICAL 20140101 OTC MONOGRAPH FINAL part346 NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD MENTHOL 1 g/100g 76179-025_de6ce48a-970a-d0ab-0a84-6ed7644735f2 76179-025 PLASMA DERIVATIVE KEDBUMIN Albumin (Human) INJECTION, SOLUTION INTRAVENOUS 20110915 BLA BLA125384 Kedrion S.p.A ALBUMIN (HUMAN) 12.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] 76181-001_7fc94125-7ed6-43e1-879a-fd58a5585578 76181-001 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen SYRUP ORAL 20110801 ANDA ANDA040482 Talec Pharma, LLC ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 76181-002_f56ea6e8-265a-4e2c-a489-2ad8a50d3157 76181-002 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate SOLUTION ORAL 20140106 ANDA ANDA040776 Talec Pharma, LLC DEXTROAMPHETAMINE SULFATE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII 76182-001_b3167729-0d12-4cfc-a8e2-9fb66ed7f287 76182-001 HUMAN OTC DRUG HUA TUO XIAN GAO CLOTRIMAZOLE OINTMENT TOPICAL 20110428 OTC MONOGRAPH FINAL part333C SHANGHAI SONGHUA PHARMACEUTICAL CO LTD CLOTRIMAZOLE 1 mg/100g 76187-762_057ffbb0-db08-4b22-8d8b-94a78c9c2d07 76187-762 HUMAN OTC DRUG Ageless Pain Relief METHYL SALICYLATE, MENTHOL CREAM TOPICAL 20110423 OTC MONOGRAPH NOT FINAL part348 Isagenix International, LLC MENTHOL; METHYL SALICYLATE 7; 14 mL/100mL; mL/100mL 76187-850_acc860e0-7142-4a7d-a4e2-5ea5d6be1ba4 76187-850 HUMAN OTC DRUG Isa SunGuard SPF 30 ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20110526 OTC MONOGRAPH FINAL part352 Isagenix International, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.3; 6 mL/100mL; mL/100mL 76187-860_1f8e222b-b905-492f-96d3-a0ba9477cd77 76187-860 HUMAN OTC DRUG Rejuvity moisturizing day cream BROAD SPECTRUM SPF 15 SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130523 OTC MONOGRAPH NOT FINAL part352 Isagenix International, LLC TITANIUM DIOXIDE; ZINC OXIDE 10; 65 mg/mL; mg/mL 76189-534_853bcdc0-4a8c-4264-9fa9-faa9d4b55623 76189-534 HUMAN PRESCRIPTION DRUG Iclusig ponatinib hydrochloride TABLET, FILM COATED ORAL 20121214 NDA NDA203469 ARIAD Pharmaceuticals, Inc. PONATINIB HYDROCHLORIDE 45 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 76189-535_853bcdc0-4a8c-4264-9fa9-faa9d4b55623 76189-535 HUMAN PRESCRIPTION DRUG Iclusig ponatinib hydrochloride TABLET, FILM COATED ORAL 20121214 NDA NDA203469 ARIAD Pharmaceuticals, Inc. PONATINIB HYDROCHLORIDE 15 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] 76204-002_f54c79f2-308f-4c04-8a6f-186fbc90bb8c 76204-002 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20121201 NDA AUTHORIZED GENERIC NDA020837 Ritedose Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 76204-003_f54c79f2-308f-4c04-8a6f-186fbc90bb8c 76204-003 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20121201 NDA AUTHORIZED GENERIC NDA020837 Ritedose Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 76204-100_757ca397-242f-4db3-b7e3-474160446cf3 76204-100 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20110201 ANDA ANDA075693 Ritedose Pharmaceuticals, LLC IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] 76204-200_57b0103f-0612-4806-a8a8-8cd02e107d96 76204-200 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20111205 ANDA ANDA077839 Ritedose Pharmaceuticals, LLC ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 76204-600_c722c52c-9d6a-4645-aed2-24128958e4e0 76204-600 HUMAN PRESCRIPTION DRUG IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20121015 ANDA ANDA202496 Ritedose Pharmaceuticals, LLC ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 2.5; .5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] 76206-001_533bb57a-b5dc-4527-a92a-6644617e265d 76206-001 HUMAN OTC DRUG COUGH BE GONE Dextromethorphan Hydrobromide Guaifenesin LIQUID ORAL 20140130 OTC MONOGRAPH FINAL part341 RFX Pharmaceutical Co., Ltd. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL 76206-002_ae0d530f-6f9a-4fdd-81c9-d7e42d421cc1 76206-002 HUMAN OTC DRUG COUGH MEDICINE soothing relief Dextromethorphan LIQUID ORAL 20140130 OTC MONOGRAPH FINAL part341 RFX Pharmaceutical Co., Ltd. DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL 76209-123_3ffce1e0-443a-42a0-815a-c1b6d7c82b87 76209-123 HUMAN OTC DRUG Cellular Laboratories De-Aging Sunscreen Broad Spectrum SPF 50 Plus HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20110503 OTC MONOGRAPH NOT FINAL part352 Market America AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 26 mg/mL; mg/mL; mg/mL; mg/mL 76209-234_0763a12b-9f53-4716-93ae-9108e1963edd 76209-234 HUMAN OTC DRUG De-Aging Moisturizing Day Creme With Sunscreen SPF 20 OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20110608 OTC MONOGRAPH FINAL part352 Market America OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 3; 3; .4 mL/100mL; mL/100mL; mL/100mL; mL/100mL 76214-001_b0ca328d-8f2d-4199-b45b-aa00c98fb956 76214-001 HUMAN OTC DRUG GOLD CAVIAR COLLAGEN SERUM FOR COSMECEUTICAL FOR WRINKLE CARE DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 1.8 mL/45mL 76214-002_96fb05a2-9b64-4dc3-88c5-bfe2367980d0 76214-002 HUMAN OTC DRUG GOLDKIWI DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 3.69 g/55g 76214-003_8d38537b-055d-47fb-8b5f-87570120411c 76214-003 HUMAN OTC DRUG AGAVE CACTUS SERUM DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE .45 mL/45mL 76214-004_5dedd490-d283-41f5-affc-840ff01ff889 76214-004 HUMAN OTC DRUG AGAVE CACTUS LIGHT DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE .45 g/45g 76214-005_698e7d93-c8a4-449c-964c-089f141a9c72 76214-005 HUMAN OTC DRUG TOMATO WHITENING SERUM DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE .35 mL/35mL 76214-006_51f56b56-9824-4309-ae05-76ef163267e5 76214-006 HUMAN OTC DRUG AGAVE CACTUS HYDRATING DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE .9 g/45g 76214-007_d8cbfe3f-0d83-436b-8995-e00bde49aac7 76214-007 HUMAN OTC DRUG OMIJA WHITENING DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 2 g/50g 76214-008_765773c1-b9b9-45d0-afb4-09329e0797df 76214-008 HUMAN OTC DRUG PLATINUM GRAPE CELL EMULSION DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 1.8 mL/130mL 76214-009_3a568818-3564-4540-8bb4-1e074db8feb0 76214-009 HUMAN OTC DRUG LEMON GINGER TEA DEODORANT ALUMINUM CHLOROHYDRATE SPRAY CUTANEOUS 20110301 OTC MONOGRAPH FINAL part350 SKINFOOD CO., LTD. ALUMINUM CHLOROHYDRATE 3 mL/100mL 76214-010_4b26437a-7999-4ae7-99a7-5bbbc01e6300 76214-010 HUMAN OTC DRUG GOLD CAVIAR SERUM DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 3.51 mL/45mL 76214-011_e833d5ab-51bd-4d3a-9661-2bbb5406f915 76214-011 HUMAN OTC DRUG ANCIENT RICE SERUM DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE .51 mL/50mL 76214-012_6209c189-d628-4727-8aac-a565a7424afb 76214-012 HUMAN OTC DRUG PEACH SAKE SUN SPF32 PA Plus Plus OCTINOXATE LOTION CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 5.25; 2.47 mL/75mL; mL/75mL 76214-013_0dff75e2-4230-4392-ac26-8b16abcaeaa9 76214-013 HUMAN OTC DRUG GOLDKIWI SUN SPF50 Plus PA Plus Plus OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.75; 1.45; 2.45 g/50g; g/50g; g/50g 76214-014_1413e5f0-f500-4104-b733-9512050efe31 76214-014 HUMAN OTC DRUG CARROT SUN SPF30 PA Plus Plus OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. AVOBENZONE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .75; 3; 2.5; 1.7 g/50g; g/50g; g/50g; g/50g 76214-015_783fcb21-2ce4-4843-bff3-52a4b600a6ed 76214-015 HUMAN OTC DRUG YAM DOUBLE CARE FLUID SPF17 PA Plus Plus OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. AVOBENZONE; ENSULIZOLE; OCTINOXATE 2.1; 1.4; 5.6 mL/140mL; mL/140mL; mL/140mL 76214-016_f16d6eda-1d77-4497-92a4-8fbdde3d1558 76214-016 HUMAN OTC DRUG PEACH SAKE PORE BB SPF20 PA Plus Number2 Natural Beige TITANIUM DIOXIDE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .9; 2.32 mL/30mL; mL/30mL 76214-017_27141064-de15-4df1-8e62-5f706f46bd8d 76214-017 HUMAN OTC DRUG PEACH SAKE PORE BB SPF20 PA Plus Number1 Light Beige TITANIUM DIOXIDE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .9; 2.32 mL/30mL; mL/30mL 76214-018_3d60ff48-3b2a-4ead-9122-980f52a42be1 76214-018 HUMAN OTC DRUG BROCCOLI SUN SPF42 PA PLUS PLUS PLUS OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.5; 2.5; 1.44; 1.9 mL/50mL; mL/50mL; mL/50mL; mL/50mL 76214-019_cb4b69e6-01fe-4955-a69c-16ff4169822c 76214-019 HUMAN OTC DRUG ALOE SUN SPF28 PA PLUS PLUS OCTINOXATE SPRAY CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. ENSULIZOLE; OCTINOXATE 2; 7 mL/100mL; mL/100mL 76214-020_19a60948-95ea-47d6-9dd6-59f466310504 76214-020 HUMAN OTC DRUG WHITENING MILK AND GREEN TEA SERUM FOR MEN DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE .35 mL/35mL 76214-021_144835d7-0fee-4568-acfb-be5f8052fbbd 76214-021 HUMAN OTC DRUG FERMENTED SOY MILK WRINKLE CARE SLEEPING MASK DIMETHICONE PATCH CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 4 g/100g 76214-022_6b4bd020-e7c3-47c6-ab29-a084d0670a47 76214-022 HUMAN OTC DRUG FERMENTED POMEGRANTE WHITENING SLEEPING MASK DIMETHICONE PATCH CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 4 g/100g 76214-023_6dd3ec2f-f08d-44ba-a515-730cfd100d21 76214-023 HUMAN OTC DRUG FRESH JUICE C WHITENING CARE DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE .5 g/50g 76214-024_ccf3634f-6479-4cf0-8a6e-67686c586b43 76214-024 HUMAN OTC DRUG FRESH JUICE E SERUM WRINKLE CARE DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 2.65 mL/50mL 76214-025_e064fb1b-2a12-463b-9308-d3c7238d8652 76214-025 HUMAN OTC DRUG FRESH JUICE E WRINKLE CARE DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 2.25 g/50g 76214-026_20289cb9-2840-4bc3-af59-b1521eb6e216 76214-026 HUMAN OTC DRUG BETULA ALBA JUICE WHITE GEL FOR MEN DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 2.72 g/50g 76214-027_273ed941-47b6-4a11-98c9-ecc2a5f7bbba 76214-027 HUMAN OTC DRUG ALOE SUN BB SPF20 PA PLUS NUMBER1 RADIANT SKIN TITANIUM DIOXIDE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 1.5; 3.86 g/50g; g/50g 76214-028_3bed856d-ed90-4ba5-be88-42bd5478f70d 76214-028 HUMAN OTC DRUG ALOE SUN BB SPF20 PA PLUS NUMBER1 NATURAL SKIN TITANIUM DIOXIDE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 1.5; 3.86 g/50g; g/50g 76214-029_11caa614-8cf5-4bba-818e-0c210f3f93f4 76214-029 HUMAN OTC DRUG TOMATO WRINKLE SUN SPF36 PA PLUS PLUS OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.5; 2.05; 1.43 mL/50mL; mL/50mL; mL/50mL 76214-030_f4bd8668-f3a0-4e83-a124-bc272714dee9 76214-030 HUMAN OTC DRUG ALOE SUN ESSENCE SPF 27 PA PLUS PLUS OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 3.5; 1.24 mL/50mL; mL/50mL 76214-031_4c5fa4ee-7698-43ef-bc32-8f277e86ffbb 76214-031 HUMAN OTC DRUG QUINCE WHITENING SUN SPF 34 PA PLUS PLUS OCTINOXATE LOTION CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 4.9; 3.5; .65 mL/70mL; mL/70mL; mL/70mL 76214-032_b3caa79f-5693-4ea6-abe6-524971743799 76214-032 HUMAN OTC DRUG CACTUS WHITENING SUN SPF 34 PA PLUS PLUS FOR MEN OCTINOXATE LOTION CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 4.9; 3.5; .65 mL/70mL; mL/70mL; mL/70mL 76214-033_d93f439a-dad7-4ad4-b856-ae5382b43383 76214-033 HUMAN OTC DRUG GOAT MILK AND LAVENDER SUN FOR BABY SPF 20 PA PLUS PLUS OCTINOXATE LOTION CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; OCTISALATE 4.9; 3.15 mL/70mL; mL/70mL 76214-034_dfb9c43e-537a-4ea3-ada2-5ac2d7cc7b23 76214-034 HUMAN OTC DRUG GOLDKIWI SUN SPF 36 PA PLUS PLUS OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.5; 2.05; 1.42 g/50g; g/50g; g/50g 76214-035_dda70e19-38b7-499a-8f60-f4dc0652e117 76214-035 HUMAN OTC DRUG TOMATO SUN SPF 36 PA PLUS PLUS OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.25; 2.12; 1.75 mL/50mL; mL/50mL; mL/50mL 76214-036_96c5bcb8-dabe-4cdd-a92c-42bee7aedf0d 76214-036 HUMAN OTC DRUG BETULA ALBA JUICE BB SPF 30 PA PLUS PLUS FOR MEN OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 3.75; 2 g/50g; g/50g 76214-037_97613899-2dd5-470d-9a9e-4634f385e6c4 76214-037 HUMAN OTC DRUG RED ORANGE SUN PACT SPF 50 PLUS PA PLUS PLUS PLUS OCTINOXATE POWDER CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .66; .29; .27 g/9.5g; g/9.5g; g/9.5g 76214-038_3cb0defc-b395-41bd-ad8a-ec355965965b 76214-038 HUMAN OTC DRUG RED ORANGE SUN SPF 45 PA PLUS PLUS PLUS TITANIUM DIOXIDE POWDER CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.79; .59 g/20g; g/20g 76214-039_74f19ed5-a039-49c9-9b0d-d664fcb2e20d 76214-039 HUMAN OTC DRUG GOLDKIWI SUN SPF 50 PLUS PA PLUS PLUS PLUS OCTINOXATE STICK CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.47; .87; 1.03 g/21g; g/21g; g/21g 76214-040_4fab789a-1295-4326-ad61-9b41d2241fac 76214-040 HUMAN OTC DRUG SKINFOOD CACAO HAND BALM HIGH MOIST TYPE GLYCERIN CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. GLYCERIN 19.2 g/48g 76214-041_9b6c2df3-1a6e-4844-8751-6a04cfe2ca89 76214-041 HUMAN OTC DRUG SKINFOOD HONEY MELON HAND BALM MOIST TYPE GLYCERIN CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. GLYCERIN 16.8 g/48g 76214-042_8b8589a9-50a1-44b6-940d-5eb9450dcda0 76214-042 HUMAN OTC DRUG RED ORANGE JELLY BB SPF20 PA PLUS PLUS NO.1 TITANIUM DIOXIDE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. TITANIUM DIOXIDE 2.32 g/25g 76214-043_7b48f300-cd09-416e-9bef-aa46ad13ae4a 76214-043 HUMAN OTC DRUG RED ORANGE JELLY BB SPF20 PA PLUS PLUS NO.2 TITANIUM DIOXIDE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. TITANIUM DIOXIDE 2.32 g/25g 76214-044_5b5187bb-b88b-4477-b32a-c086b5e93bcd 76214-044 HUMAN OTC DRUG GOOD AFTERNOON BERRY BERRY TEA BB SPF35 PA PLUS PLUS NO.1 TITANIUM DIOXIDE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 2.9; .88 g/30g; g/30g; g/30g 76214-045_86563d4d-eab9-4e6b-aa2e-3147e8ad7bc0 76214-045 HUMAN OTC DRUG GOOD AFTERNOON BERRY BERRY TEA BB SPF35 PA PLUS PLUS NO.2 TITANIUM DIOXIDE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 2.9; .88 g/30g; g/30g; g/30g 76214-046_47b3aadf-1f53-4275-853b-9681da318602 76214-046 HUMAN OTC DRUG ALOE SUN BB SPF50 PLUS PA PLUS PLUS PLUS ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.5; 1.75; 2.36; 2.7 g/50g; g/50g; g/50g; g/50g 76214-047_89a3cb88-5d41-4740-ad8e-6593481248d3 76214-047 HUMAN OTC DRUG SKINFOOD ALOE SUN BB ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.5; 1.75; 2.36; 2.7 g/50g; g/50g; g/50g; g/50g 76214-048_409ae570-45a5-4ad3-82bc-f19a53e4fc16 76214-048 HUMAN OTC DRUG VITA WATER DROP CC TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 2.15; .29 g/30g; g/30g; g/30g 76218-0405_d0d27637-35fb-4bf3-aa6e-bd8933ce1e83 76218-0405 HUMAN PRESCRIPTION DRUG Quazepam QUAZEPAM TABLET ORAL 20130808 NDA NDA018708 KLE 2, Inc. QUAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76218-0708_a59adc64-f753-4b11-887a-401106f65e5c 76218-0708 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120314 NDA NDA022370 KLE 2, Inc. TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 76218-1215_7fe1991a-0b9c-4ff5-8dc0-568e235a4ad8 76218-1215 HUMAN PRESCRIPTION DRUG Fenoprofen fenoprofen CAPSULE ORAL 20140714 NDA NDA017604 KLE 2, Inc. FENOPROFEN CALCIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 76218-1219_c8b3ebad-9f16-4079-a243-7be385852405 76218-1219 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20110829 ANDA ANDA078722 KLE 2, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 76224-101_08b50aa0-79e9-4d93-a3bc-bf61410f21d4 76224-101 HUMAN OTC DRUG SPF 15 Self Tanner OCTINOXATE,OXYBENZONE LOTION TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part352 Whish Body Holdings Inc OCTINOXATE; OXYBENZONE 7.5; 5 mL/100mL; mL/100mL 76229-123_4c9f424a-e87e-489c-89c7-3d24e0cf8ad0 76229-123 HUMAN OTC DRUG Likewise Hand Moisturizer - Sun Protectant SPF 50 OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20110620 OTC MONOGRAPH FINAL part352 Likewise Incorporated OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 11.16 mL/100mL; mL/100mL; mL/100mL 76229-234_190c9fd2-dbbf-476b-9385-e45d476d05a1 76229-234 HUMAN OTC DRUG Likewise Facial Moisturizer - Sun Protectant SPF 50 Oily Skin TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110620 OTC MONOGRAPH FINAL part352 Likewise Incorporated TITANIUM DIOXIDE; ZINC OXIDE 6.5; 6.65 mL/100mL; mL/100mL 76229-345_fe78d256-7f16-4d49-a724-8582eb8b0d89 76229-345 HUMAN OTC DRUG Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Oily Skin OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20110620 OTC MONOGRAPH FINAL part352 Likewise Incorporated OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 11.16 mL/100mL; mL/100mL; mL/100mL 76229-456_54c08f20-4302-4b63-87dc-dd2d06b2e767 76229-456 HUMAN OTC DRUG Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Dry Skin OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20110514 OTC MONOGRAPH FINAL part352 Likewise Incorporated OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 11.16 mL/100mL; mL/100mL; mL/100mL 76230-727_58d2f63d-fc89-4630-b456-7b22be39073b 76230-727 HUMAN OTC DRUG Everyday Facial Moisturizer And Sunscreen SPF 20 ZINC OXIDE CREAM TOPICAL 20110609 OTC MONOGRAPH FINAL part352 714 Essentials LTD ZINC OXIDE 16.32 mL/100mL 76234-000_c5b3af32-3502-4828-8de2-cccb3f2a3994 76234-000 HUMAN PRESCRIPTION DRUG Aceon perindopril erbumine TABLET ORAL 19931230 NDA NDA020184 XOMA (US) LLC PERINDOPRIL ERBUMINE 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76234-001_c5b3af32-3502-4828-8de2-cccb3f2a3994 76234-001 HUMAN PRESCRIPTION DRUG Aceon perindopril erbumine TABLET ORAL 19931230 NDA NDA020184 XOMA (US) LLC PERINDOPRIL ERBUMINE 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76234-002_c5b3af32-3502-4828-8de2-cccb3f2a3994 76234-002 HUMAN PRESCRIPTION DRUG Aceon perindopril erbumine TABLET ORAL 19931230 NDA NDA020184 XOMA (US) LLC PERINDOPRIL ERBUMINE 8 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76237-100_a205f605-59ea-4348-8587-93b538e41302 76237-100 HUMAN OTC DRUG Mapap ACETAMINOPHEN TABLET ORAL 20110829 UNAPPROVED DRUG OTHER McKesson Contract Packaging ACETAMINOPHEN 325 mg/1 76237-101_573be06c-e271-4443-b727-5e4506fa28e5 76237-101 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN CAPSULE ORAL 20111004 UNAPPROVED HOMEOPATHIC McKesson Contract Packaging ACETAMINOPHEN 500 mg/1 76237-102_3808efbf-a81b-4ce2-8db0-56fa676d736b 76237-102 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN TABLET ORAL 20111220 UNAPPROVED DRUG OTHER McKesson Contract Packaging ACETAMINOPHEN 500 mg/1 76237-103_79fb3828-3b00-4b01-a135-b3ca456168ed 76237-103 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20111021 ANDA ANDA088628 McKesson Contract Packaging ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII 76237-104_c58b2502-67fa-4535-97a0-4c6b4043a38f 76237-104 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20111216 ANDA ANDA018659 McKesson Contract Packaging ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] 76237-105_a0bc8740-7a93-444d-9d6e-d40faa1d58cc 76237-105 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20111024 ANDA ANDA074342 McKesson Contract Packaging ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76237-106_a0bc8740-7a93-444d-9d6e-d40faa1d58cc 76237-106 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20111017 ANDA ANDA074342 McKesson Contract Packaging ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76237-107_a0bc8740-7a93-444d-9d6e-d40faa1d58cc 76237-107 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20111017 ANDA ANDA074342 McKesson Contract Packaging ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76237-108_48f8c54d-0d7e-4469-86ca-93221d6c8f7d 76237-108 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20120103 ANDA ANDA075315 McKesson Contract Packaging AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] 76237-109_48072673-1f7f-4fa8-aebb-00b4dba4a0ae 76237-109 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20110914 ANDA ANDA076418 McKesson Contract Packaging AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 76237-110_48072673-1f7f-4fa8-aebb-00b4dba4a0ae 76237-110 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20110914 ANDA ANDA076418 McKesson Contract Packaging AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 76237-111_48072673-1f7f-4fa8-aebb-00b4dba4a0ae 76237-111 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20110914 ANDA ANDA076418 McKesson Contract Packaging AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 76237-112_5f410e51-c1a4-4b1b-8d18-fef788bb5c04 76237-112 HUMAN OTC DRUG Micro-Coated Aspirin Micro-Coated Aspirin TABLET ORAL 20110930 UNAPPROVED DRUG OTHER McKesson Contract Packaging ASPIRIN 325 mg/1 76237-113_20e6238d-9c29-494a-82ab-ea45736dda07 76237-113 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 20111117 UNAPPROVED MEDICAL GAS McKesson Contract Packaging ASPIRIN 81 mg/1 76237-115_865ea555-ba24-4f2c-8791-cf681b76ad3f 76237-115 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20111003 ANDA ANDA074052 McKesson Contract Packaging ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 76237-116_cad3d03b-4e1b-434f-90f1-cca2789e96ab 76237-116 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20111228 ANDA ANDA073457 McKesson Contract Packaging ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 76237-117_6dee51a6-9a37-4cb2-9266-b8a698402aa2 76237-117 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20111114 ANDA ANDA072234 McKesson Contract Packaging BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 76237-118_6dee51a6-9a37-4cb2-9266-b8a698402aa2 76237-118 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20111212 ANDA ANDA072235 McKesson Contract Packaging BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] 76237-120_4e15d6e7-7f85-44a0-8169-aa1312a32f37 76237-120 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20111208 ANDA ANDA089059 McKesson Contract Packaging BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 76237-121_aca8b358-d172-43d6-95bb-8064b8ed680c 76237-121 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20111107 ANDA ANDA075022 McKesson Contract Packaging BUSPIRONE HYDROCHLORIDE 5 mg/1 76237-122_aca8b358-d172-43d6-95bb-8064b8ed680c 76237-122 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20111121 ANDA ANDA075022 McKesson Contract Packaging BUSPIRONE HYDROCHLORIDE 10 mg/1 76237-126_a3f9a1e3-133e-4a97-be1e-d92deef34ddc 76237-126 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 20111007 ANDA ANDA070541 McKesson Contract Packaging CARBAMAZEPINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 76237-127_6fca30bd-28e5-4e32-b194-97c84966900d 76237-127 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET, CHEWABLE ORAL 20110901 ANDA ANDA075712 McKesson Contract Packaging CARBAMAZEPINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA] 76237-129_d17e17d5-f73a-49c5-b1bd-2543cc486edf 76237-129 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20111011 ANDA ANDA074260 McKesson Contract Packaging CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 76237-130_d17e17d5-f73a-49c5-b1bd-2543cc486edf 76237-130 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20111221 ANDA ANDA074260 McKesson Contract Packaging CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 76237-131_577b23c1-bd6d-41a4-a7c5-ebe7b92e37bd 76237-131 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20110920 ANDA ANDA078227 McKesson Contract Packaging CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 76237-132_577b23c1-bd6d-41a4-a7c5-ebe7b92e37bd 76237-132 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20110922 ANDA ANDA078227 McKesson Contract Packaging CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 76237-133_577b23c1-bd6d-41a4-a7c5-ebe7b92e37bd 76237-133 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20110921 ANDA ANDA078227 McKesson Contract Packaging CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 76237-134_577b23c1-bd6d-41a4-a7c5-ebe7b92e37bd 76237-134 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20110921 ANDA ANDA078227 McKesson Contract Packaging CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] 76237-135_9ce0e304-583e-4850-ba40-c3534cf1b068 76237-135 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110922 ANDA ANDA077048 McKesson Contract Packaging CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76237-136_9ce0e304-583e-4850-ba40-c3534cf1b068 76237-136 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110901 ANDA ANDA077048 McKesson Contract Packaging CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76237-137_9ce0e304-583e-4850-ba40-c3534cf1b068 76237-137 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110922 ANDA ANDA077048 McKesson Contract Packaging CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76237-138_5da72d49-de2b-4e23-bb78-9eb4d98b8974 76237-138 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20111011 ANDA ANDA074869 McKesson Contract Packaging CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76237-139_5da72d49-de2b-4e23-bb78-9eb4d98b8974 76237-139 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20111012 ANDA ANDA074869 McKesson Contract Packaging CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76237-140_5da72d49-de2b-4e23-bb78-9eb4d98b8974 76237-140 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20111018 ANDA ANDA074869 McKesson Contract Packaging CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76237-141_835bb6d3-6437-499d-85e5-e012f17d356c 76237-141 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20120110 ANDA ANDA070974 McKesson Contract Packaging CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 76237-142_835bb6d3-6437-499d-85e5-e012f17d356c 76237-142 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20111003 ANDA ANDA070975 McKesson Contract Packaging CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 76237-143_19567e4e-2afe-41e7-b8d1-956843b75687 76237-143 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20110929 ANDA ANDA077797 McKesson Contract Packaging CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 76237-144_facbab47-582b-4ad6-b18f-8ecf1d4bc8fb 76237-144 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20111013 ANDA ANDA071321 McKesson Contract Packaging DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76237-145_facbab47-582b-4ad6-b18f-8ecf1d4bc8fb 76237-145 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20091109 ANDA ANDA071322 McKesson Contract Packaging DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76237-146_6873ef01-b305-4a94-89ff-89d93298920c 76237-146 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20111011 ANDA ANDA077002 McKesson Contract Packaging DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 76237-147_2ff06b26-430d-4710-99ee-1f060079cc58 76237-147 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20111104 ANDA ANDA072838 McKesson Contract Packaging DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 76237-148_2ff06b26-430d-4710-99ee-1f060079cc58 76237-148 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20110922 ANDA ANDA072838 McKesson Contract Packaging DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] 76237-149_127adef8-5b73-4217-899c-31fbd95c6bdf 76237-149 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20111107 ANDA ANDA085762 McKesson Contract Packaging ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV 76237-150_54f6e14f-7c38-4c4f-85fc-cf5b25589ba9 76237-150 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110103 ANDA ANDA078182 McKesson Contract Packaging DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 76237-151_54f6e14f-7c38-4c4f-85fc-cf5b25589ba9 76237-151 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111017 ANDA ANDA078182 McKesson Contract Packaging DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 76237-152_54f6e14f-7c38-4c4f-85fc-cf5b25589ba9 76237-152 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110829 ANDA ANDA078182 McKesson Contract Packaging DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 76237-153_cf18a4c9-ba0b-4ac3-88b8-cc5889b0898f 76237-153 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120223 ANDA ANDA077567 McKesson Contract Packaging DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 76237-154_cf18a4c9-ba0b-4ac3-88b8-cc5889b0898f 76237-154 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111014 ANDA ANDA077567 McKesson Contract Packaging DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 76237-155_c41abc6d-1918-4b35-80cc-2b3c019822d6 76237-155 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium CAPSULE ORAL 20111214 ANDA ANDA078979 McKesson Contract Packaging DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 76237-157_a6355634-dab6-4995-b608-898988d14ad9 76237-157 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20111025 ANDA ANDA075511 McKesson Contract Packaging FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 76237-159_28d1233a-12b6-4b24-9ab6-079b005826ae 76237-159 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20111017 ANDA ANDA076001 McKesson Contract Packaging FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76237-160_7bdfb785-2462-4b8e-bdaf-508f9b464526 76237-160 HUMAN PRESCRIPTION DRUG folic acid folic acid TABLET ORAL 20120305 ANDA ANDA080600 McKesson Contract Packaging FOLIC ACID 1 mg/1 76237-161_ede2dd16-2ab8-40c3-b490-8cc760c8278e 76237-161 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20111007 ANDA ANDA018413 McKesson Contract Packaging FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 76237-162_ede2dd16-2ab8-40c3-b490-8cc760c8278e 76237-162 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20111011 ANDA ANDA018413 McKesson Contract Packaging FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 76237-163_3a2c0f3a-7cdb-49b2-9215-e8efcc66e05f 76237-163 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110829 ANDA ANDA018569 McKesson Contract Packaging FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] 76237-164_78edc5af-9a37-45f7-893a-414eb890f07b 76237-164 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110829 ANDA ANDA075350 McKesson Contract Packaging GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76237-165_66e3f3fd-5e5e-4db6-a32e-40a88fef42fc 76237-165 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110829 ANDA ANDA075350 McKesson Contract Packaging GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76237-166_78edc5af-9a37-45f7-893a-414eb890f07b 76237-166 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20111209 ANDA ANDA075350 McKesson Contract Packaging GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76237-167_8a300ebc-7f47-42e7-942b-921584eada3d 76237-167 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111109 ANDA ANDA075694 McKesson Contract Packaging GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76237-168_694abc50-a512-423f-9bf0-f8d9ac99f030 76237-168 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20110919 ANDA ANDA074256 McKesson Contract Packaging GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 76237-169_a82e0444-5ea7-45e6-9cde-97af77eb9a8e 76237-169 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20111003 ANDA ANDA074226 McKesson Contract Packaging GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 76237-170_a82e0444-5ea7-45e6-9cde-97af77eb9a8e 76237-170 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20111122 ANDA ANDA074226 McKesson Contract Packaging GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 76237-171_4dc7d63c-a178-4d8a-bfb8-2bfb974021a2 76237-171 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20120109 ANDA ANDA074388 McKesson Contract Packaging GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 76237-172_6ce41f90-e721-4141-8ea6-8c89e64099dd 76237-172 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20111202 ANDA ANDA087836 McKesson Contract Packaging HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 76237-173_6ce41f90-e721-4141-8ea6-8c89e64099dd 76237-173 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20111025 ANDA ANDA086961 McKesson Contract Packaging HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 76237-174_6ce41f90-e721-4141-8ea6-8c89e64099dd 76237-174 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20111025 ANDA ANDA086962 McKesson Contract Packaging HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] 76237-175_7048941e-b9b0-4d40-96bd-66f7a5b0bd5e 76237-175 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 19961227 NDA AUTHORIZED GENERIC NDA020504 McKesson Contract Packaging HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 76237-176_329f0bd2-e285-4d97-b3c1-f710699a0f41 76237-176 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20111012 ANDA ANDA040412 McKesson Contract Packaging HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 76237-177_a6de48ff-3c76-451c-94f7-de8e8df694b2 76237-177 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111005 ANDA ANDA040400 McKesson Contract Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 76237-178_a6de48ff-3c76-451c-94f7-de8e8df694b2 76237-178 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111017 ANDA ANDA040201 McKesson Contract Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 76237-179_a6de48ff-3c76-451c-94f7-de8e8df694b2 76237-179 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111122 ANDA ANDA040084 McKesson Contract Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 650; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 76237-180_a6de48ff-3c76-451c-94f7-de8e8df694b2 76237-180 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111010 ANDA ANDA040409 McKesson Contract Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 76237-181_a6de48ff-3c76-451c-94f7-de8e8df694b2 76237-181 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111010 ANDA ANDA089160 McKesson Contract Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 76237-182_a6de48ff-3c76-451c-94f7-de8e8df694b2 76237-182 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111006 ANDA ANDA040405 McKesson Contract Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 76237-183_a6de48ff-3c76-451c-94f7-de8e8df694b2 76237-183 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111017 ANDA ANDA040201 McKesson Contract Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 500; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 76237-185_a6de48ff-3c76-451c-94f7-de8e8df694b2 76237-185 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111104 ANDA ANDA040084 McKesson Contract Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 750; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 76237-186_7e5df0ab-3d66-43c8-80a6-f1ad8a95b43c 76237-186 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120123 ANDA ANDA040787 McKesson Contract Packaging HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] 76237-187_85b6a65b-fde0-47bf-91a1-4acc6d7d5846 76237-187 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20120105 ANDA ANDA078558 McKesson Contract Packaging IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 76237-188_85b6a65b-fde0-47bf-91a1-4acc6d7d5846 76237-188 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20111222 ANDA ANDA078558 McKesson Contract Packaging IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 76237-189_778d36de-3d3b-4d56-9e33-3cc2a3178c7a 76237-189 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 20110922 ANDA ANDA086066 McKesson Contract Packaging ISOSORBIDE DINITRATE 10 mg/1 76237-190_778d36de-3d3b-4d56-9e33-3cc2a3178c7a 76237-190 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 20111104 ANDA ANDA088088 McKesson Contract Packaging ISOSORBIDE DINITRATE 20 mg/1 76237-191_f160ab83-126f-4e99-845a-7b27622c377f 76237-191 HUMAN PRESCRIPTION DRUG Isosorbide mononitrate Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110913 ANDA ANDA076813 McKesson Contract Packaging ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 76237-192_f160ab83-126f-4e99-845a-7b27622c377f 76237-192 HUMAN PRESCRIPTION DRUG Isosorbide mononitrate Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111128 ANDA ANDA076813 McKesson Contract Packaging ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 76237-193_c555224c-2d01-4dc7-b5de-6edf095d6313 76237-193 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20111205 ANDA ANDA074726 McKesson Contract Packaging POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 76237-194_c555224c-2d01-4dc7-b5de-6edf095d6313 76237-194 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20111207 ANDA ANDA074726 McKesson Contract Packaging POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 76237-195_234ea375-5df6-4e0e-b3bc-2a08fa5a0b11 76237-195 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20110901 ANDA ANDA078402 McKesson Contract Packaging LISINOPRIL 2.5 mg/1 76237-196_234ea375-5df6-4e0e-b3bc-2a08fa5a0b11 76237-196 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20110907 ANDA ANDA078402 McKesson Contract Packaging LISINOPRIL 5 mg/1 76237-197_234ea375-5df6-4e0e-b3bc-2a08fa5a0b11 76237-197 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20110908 ANDA ANDA078402 McKesson Contract Packaging LISINOPRIL 10 mg/1 76237-198_234ea375-5df6-4e0e-b3bc-2a08fa5a0b11 76237-198 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20110909 ANDA ANDA078402 McKesson Contract Packaging LISINOPRIL 20 mg/1 76237-199_234ea375-5df6-4e0e-b3bc-2a08fa5a0b11 76237-199 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20110916 ANDA ANDA078402 McKesson Contract Packaging LISINOPRIL 40 mg/1 76237-200_39deeb78-f9c3-421e-8455-ff5ab6820718 76237-200 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 20120126 ANDA ANDA072741 McKesson Contract Packaging LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] 76237-201_7145015c-8c81-4ca2-9a7d-e6b71d789707 76237-201 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20110926 ANDA ANDA075209 McKesson Contract Packaging LORATADINE 10 mg/1 76237-202_0d266c0d-167c-4a28-a6ef-924d5d117e50 76237-202 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20111223 ANDA ANDA077936 McKesson Contract Packaging MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 76237-205_9558e870-aa8b-4646-a701-1e9416c02f11 76237-205 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride TABLET ORAL 20111004 ANDA ANDA072801 McKesson Contract Packaging METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 76237-206_201e71d6-6a69-4ca8-9eb6-9821f45f8d18 76237-206 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide hydrochloride TABLET ORAL 20110930 ANDA ANDA070581 McKesson Contract Packaging METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 76237-207_d2fbe47f-2f30-4442-857d-c6b517a2c5e4 76237-207 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20111006 ANDA ANDA076704 McKesson Contract Packaging METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 76237-208_d0f4d3f2-af08-447a-848f-cfd7bddd2034 76237-208 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20111004 ANDA ANDA074644 McKesson Contract Packaging METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 76237-209_d0f4d3f2-af08-447a-848f-cfd7bddd2034 76237-209 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20111104 ANDA ANDA074644 McKesson Contract Packaging METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 76237-210_d9578264-6ae5-44e3-90af-6ba61fe270a5 76237-210 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20111026 ANDA ANDA076122 McKesson Contract Packaging MIRTAZAPINE 15 mg/1 76237-211_d9578264-6ae5-44e3-90af-6ba61fe270a5 76237-211 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20120131 ANDA ANDA076122 McKesson Contract Packaging MIRTAZAPINE 30 mg/1 76237-214_b62dfe64-7212-48ae-b8cd-d426c7f178cd 76237-214 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20120125 ANDA ANDA074201 McKesson Contract Packaging NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 76237-215_25f60261-6c53-42ac-905b-48f7ee87589d 76237-215 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20030128 ANDA ANDA075757 McKesson Contract Packaging OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] 76237-216_0c019ff6-ce85-4711-a9d1-39804ebfae56 76237-216 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 20111223 ANDA ANDA075079 McKesson Contract Packaging OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 76237-217_e2d6e56e-43dc-4724-a158-0a690c644d97 76237-217 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111012 ANDA ANDA076702 McKesson Contract Packaging OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 76237-218_e2d6e56e-43dc-4724-a158-0a690c644d97 76237-218 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110919 ANDA ANDA076644 McKesson Contract Packaging OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 76237-221_ea2e434b-c25a-4761-a81c-a4a1a0e0d579 76237-221 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20110916 ANDA ANDA077584 McKesson Contract Packaging PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76237-222_4d2db83d-8df4-46de-bf04-91405a166b8d 76237-222 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120220 UNAPPROVED DRUG OTHER McKesson Contract Packaging PHENOBARBITAL 15 mg/1 CIV 76237-223_4d2db83d-8df4-46de-bf04-91405a166b8d 76237-223 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20111024 UNAPPROVED DRUG OTHER McKesson Contract Packaging PHENOBARBITAL 30 mg/1 CIV 76237-224_4d2db83d-8df4-46de-bf04-91405a166b8d 76237-224 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20111114 UNAPPROVED DRUG OTHER McKesson Contract Packaging PHENOBARBITAL 60 mg/1 CIV 76237-225_6b902d5e-1526-4f80-bb31-57c1b4e5a4f5 76237-225 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120130 ANDA ANDA074425 McKesson Contract Packaging PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] 76237-226_c020c1e8-5d37-4e7e-a7c2-b7ded1b8a60b 76237-226 HUMAN PRESCRIPTION DRUG Phenytoin Sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20110919 ANDA ANDA040298 McKesson Contract Packaging PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76237-227_f55cecd1-013d-4db5-9d62-e2cd53f253e4 76237-227 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20111012 ANDA ANDA080352 McKesson Contract Packaging PREDNISONE 5 mg/1 76237-228_f55cecd1-013d-4db5-9d62-e2cd53f253e4 76237-228 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20111220 ANDA ANDA084122 McKesson Contract Packaging PREDNISONE 10 mg/1 76237-229_4e6e3e52-a978-4550-be38-21e74bda5a6a 76237-229 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20111227 ANDA ANDA084903 McKesson Contract Packaging PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76237-230_0af133fc-a27d-4099-908a-0bdf7c64f22b 76237-230 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110914 ANDA ANDA084234 McKesson Contract Packaging PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 76237-231_474075ad-691d-4d9b-8b4c-b661a48a76f0 76237-231 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20111026 ANDA ANDA075165 McKesson Contract Packaging RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 76237-232_1b8dae50-1ae4-4cad-859d-feac54d06abc 76237-232 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20111013 ANDA ANDA076288 McKesson Contract Packaging RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] 76237-233_1b8dae50-1ae4-4cad-859d-feac54d06abc 76237-233 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20111013 ANDA ANDA076288 McKesson Contract Packaging RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] 76237-234_1b8dae50-1ae4-4cad-859d-feac54d06abc 76237-234 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20110922 ANDA ANDA072688 McKesson Contract Packaging RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] 76237-235_1b8dae50-1ae4-4cad-859d-feac54d06abc 76237-235 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20110914 ANDA ANDA072688 McKesson Contract Packaging RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] 76237-236_1b8dae50-1ae4-4cad-859d-feac54d06abc 76237-236 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20120103 ANDA ANDA072688 McKesson Contract Packaging RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] 76237-237_5ab88ada-8c6d-4cda-a8ef-8ab07cc53a9a 76237-237 HUMAN OTC DRUG Senna-Lax SENNOSIDES A AND B TABLET, FILM COATED ORAL 20110928 OTC MONOGRAPH NOT FINAL part334 McKesson Contract Packaging SENNOSIDES A AND B 8.6 mg/1 76237-239_22cb97e4-02b9-4e7b-8540-14659739dad4 76237-239 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20110927 ANDA ANDA077397 McKesson Contract Packaging SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76237-240_22cb97e4-02b9-4e7b-8540-14659739dad4 76237-240 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20110927 ANDA ANDA077397 McKesson Contract Packaging SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76237-241_22cb97e4-02b9-4e7b-8540-14659739dad4 76237-241 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20110927 ANDA ANDA077397 McKesson Contract Packaging SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76237-242_dcd8802a-bf53-40da-8489-686f4a0610b3 76237-242 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111013 ANDA ANDA077752 McKesson Contract Packaging SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 76237-243_dcd8802a-bf53-40da-8489-686f4a0610b3 76237-243 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20110818 ANDA ANDA077752 McKesson Contract Packaging SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 76237-244_dcd8802a-bf53-40da-8489-686f4a0610b3 76237-244 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111014 ANDA ANDA077752 McKesson Contract Packaging SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 76237-246_6ac04cc4-b044-45a3-ac41-a4dfc4969697 76237-246 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20111207 ANDA ANDA040424 McKesson Contract Packaging SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] 76237-247_2bde09da-d053-447e-84e5-a3cc29abd91b 76237-247 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20111129 ANDA ANDA070848 McKesson Contract Packaging SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] 76237-248_24b0946d-25dd-457b-b1bf-7fbc7521a84b 76237-248 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20110922 ANDA ANDA076899 McKesson Contract Packaging SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] 76237-250_3a334e15-2b7f-4d75-8df4-d50f047ec831 76237-250 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20111206 ANDA ANDA071427 McKesson Contract Packaging TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76237-251_3a334e15-2b7f-4d75-8df4-d50f047ec831 76237-251 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20111121 ANDA ANDA071428 McKesson Contract Packaging TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76237-252_d0d913a9-cfe8-4a7e-b20d-ea51828a01a1 76237-252 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20120223 ANDA ANDA076286 McKesson Contract Packaging TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] 76237-253_376c3363-2a07-4ddf-8b31-8c32fbe1e99a 76237-253 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride tramadol hydrochloride TABLET, FILM COATED ORAL 20111019 ANDA ANDA075986 McKesson Contract Packaging TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV 76237-254_072c4627-897d-4659-bbb3-aa3777e161de 76237-254 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20111011 ANDA ANDA071523 McKesson Contract Packaging TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] 76237-255_072c4627-897d-4659-bbb3-aa3777e161de 76237-255 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20120125 ANDA ANDA071524 McKesson Contract Packaging TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] 76237-257_d8e85f5e-381a-485b-9aba-78fa0837aab0 76237-257 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20111020 ANDA ANDA077322 McKesson Contract Packaging ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 76237-258_d8e85f5e-381a-485b-9aba-78fa0837aab0 76237-258 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20111021 ANDA ANDA077322 McKesson Contract Packaging ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV 76237-259_b4b398bc-399c-4832-adef-baf2019c633d 76237-259 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, EXTENDED RELEASE ORAL 20120208 ANDA ANDA075091 McKesson Contract Packaging CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA] 76237-260_d7583513-56e8-4e9e-a7b9-f56cb15e85b6 76237-260 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20130410 ANDA ANDA070278 McKesson Contract Packaging HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] 76237-261_867fb3a7-615d-4e06-9a9c-1c6a0285bbc0 76237-261 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20120321 ANDA ANDA074787 McKesson Contract Packaging LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 76237-262_2c979c14-8820-4101-8ecd-f6efb2dddcc7 76237-262 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111130 ANDA ANDA076388 McKesson Contract Packaging LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 76237-263_2c979c14-8820-4101-8ecd-f6efb2dddcc7 76237-263 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130513 ANDA ANDA076388 McKesson Contract Packaging LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] 76237-264_f44e0069-84cf-40e2-a4e8-57494131c65d 76237-264 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20111012 ANDA ANDA076919 McKesson Contract Packaging LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76237-265_f44e0069-84cf-40e2-a4e8-57494131c65d 76237-265 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20111123 ANDA ANDA076919 McKesson Contract Packaging LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76237-269_1b8dae50-1ae4-4cad-859d-feac54d06abc 76237-269 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20130513 ANDA ANDA076288 McKesson Contract Packaging RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] 76237-270_dcab3f2d-1b03-4316-8540-9f974c289215 76237-270 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 20120103 ANDA ANDA087128 McKesson Contract Packaging MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] 76237-271_c6c86ef1-5a9d-4fa8-9996-d61d3c5f5f16 76237-271 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20120118 ANDA ANDA075978 McKesson Contract Packaging METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 76237-272_c6c86ef1-5a9d-4fa8-9996-d61d3c5f5f16 76237-272 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20120117 ANDA ANDA075978 McKesson Contract Packaging METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] 76237-273_097505e3-6abd-490d-89b9-334944c59b04 76237-273 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20120202 ANDA ANDA040863 McKesson Contract Packaging PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] 76237-274_4c29b6c0-174b-4de2-b1da-7033397db7d3 76237-274 HUMAN PRESCRIPTION DRUG benztropine mesylate benztropine mesylate TABLET ORAL 20130221 ANDA ANDA040103 McKesson Contract Packaging BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 76237-275_4c29b6c0-174b-4de2-b1da-7033397db7d3 76237-275 HUMAN PRESCRIPTION DRUG benztropine mesylate benztropine mesylate TABLET ORAL 20120207 ANDA ANDA040103 McKesson Contract Packaging BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 76237-276_894ece20-b681-4b7b-a452-113844594b31 76237-276 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20120416 ANDA ANDA076001 McKesson Contract Packaging FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76237-277_bd50c5cf-37b6-46af-9b53-6b018e872cef 76237-277 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20130410 ANDA ANDA201001 McKesson Contract Packaging DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 76237-278_bd50c5cf-37b6-46af-9b53-6b018e872cef 76237-278 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20130410 ANDA ANDA201001 McKesson Contract Packaging DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] 76237-279_997a751c-9ce1-4089-872b-380abed42706 76237-279 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20130415 NDA AUTHORIZED GENERIC NDA018238 McKesson Contract Packaging POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 76237-280_4d201395-b244-423f-9f6b-91f88cca6971 76237-280 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20130409 ANDA ANDA077728 McKesson Contract Packaging CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 76237-282_12049b80-7800-4f13-a799-45009661b8d1 76237-282 HUMAN OTC DRUG mapap arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130409 ANDA ANDA075077 McKesson Contract Packaging ACETAMINOPHEN 650 mg/1 76237-284_d1f6fa09-cea1-4086-8c2a-e27e9a409253 76237-284 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20130410 ANDA ANDA076958 McKesson Contract Packaging LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 76237-285_1fea6d90-2211-4005-b8b1-280b9abf59c7 76237-285 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20130412 ANDA ANDA076056 McKesson Contract Packaging PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 76237-286_148826a2-5a25-4e70-a086-a2f04eff9849 76237-286 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20130510 ANDA ANDA090408 McKesson Contract Packaging TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 76237-289_62b4c73b-416b-4cbc-af96-37e703ff6078 76237-289 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20120828 ANDA ANDA077657 McKesson Contract Packaging LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76237-290_62b4c73b-416b-4cbc-af96-37e703ff6078 76237-290 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20120907 ANDA ANDA077657 McKesson Contract Packaging LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76237-291_62b4c73b-416b-4cbc-af96-37e703ff6078 76237-291 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20121018 ANDA ANDA077657 McKesson Contract Packaging LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV 76237-294_30198c4d-0f5e-4de5-a314-e134890d5983 76237-294 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20120928 ANDA ANDA076268 McKesson Contract Packaging DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] 76237-296_48d366cd-69c1-459a-b1f1-25e470184d3a 76237-296 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20121026 ANDA ANDA077691 McKesson Contract Packaging SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 76237-297_48d366cd-69c1-459a-b1f1-25e470184d3a 76237-297 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130219 ANDA ANDA077691 McKesson Contract Packaging SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 76237-299_aaa54641-99e7-4082-83ae-8a7c84fcae04 76237-299 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20130314 ANDA ANDA070581 McKesson Contract Packager METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] 76237-300_b407f9c5-721e-4cfd-8bc2-b22c8646bc29 76237-300 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20130328 ANDA ANDA090598 McKesson Contract Packaging ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 76237-301_b407f9c5-721e-4cfd-8bc2-b22c8646bc29 76237-301 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20130228 ANDA ANDA090598 McKesson Contract Packaging ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 76237-302_891194e8-7083-4438-8d27-c72f2372e40f 76237-302 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130613 ANDA ANDA200270 McKesson Contract Packaging ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 76237-303_891194e8-7083-4438-8d27-c72f2372e40f 76237-303 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130613 ANDA ANDA200495 McKesson Contract Packaging ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 76237-304_194344a6-13c8-4b24-9ad9-8fe0adcf0485 76237-304 HUMAN PRESCRIPTION DRUG Lisinopril 2.5mg Lisinopril TABLET ORAL 20130801 ANDA ANDA075994 Mckesson Contract Packaging LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76237-307_194344a6-13c8-4b24-9ad9-8fe0adcf0485 76237-307 HUMAN PRESCRIPTION DRUG Lisinopril 5mg Lisinopril TABLET ORAL 20130801 ANDA ANDA075994 Mckesson Contract Packaging LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76237-309_194344a6-13c8-4b24-9ad9-8fe0adcf0485 76237-309 HUMAN PRESCRIPTION DRUG Lisinopril 10mg Lisinopril TABLET ORAL 20130801 ANDA ANDA075994 Mckesson Contract Packaging LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76237-312_194344a6-13c8-4b24-9ad9-8fe0adcf0485 76237-312 HUMAN PRESCRIPTION DRUG Lisinopril 20mg Lisinopril TABLET ORAL 20130801 ANDA ANDA075994 Mckesson Contract Packaging LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76237-314_194344a6-13c8-4b24-9ad9-8fe0adcf0485 76237-314 HUMAN PRESCRIPTION DRUG Lisinopril 40mg Lisinopril TABLET ORAL 20130801 ANDA ANDA075994 Mckesson Contract Packaging LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76237-315_a3dba79a-a210-426c-bb16-b5fcad72f577 76237-315 HUMAN OTC DRUG SENEXON-S DOCUSATE SODIUM -SENNOSIDES TABLET, COATED ORAL 20130729 OTC MONOGRAPH NOT FINAL part334 McKesson Contract Packaging DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 76237-316_5a5588f0-9452-4e48-8876-6dafbf37a767 76237-316 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140317 ANDA ANDA075350 McKesson Contract Packaging GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76237-336_1b613496-07ab-4e62-9e80-1dcebea58ed6 76237-336 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111010 ANDA ANDA040409 McKesson Contract Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 76237-400_1b613496-07ab-4e62-9e80-1dcebea58ed6 76237-400 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111006 ANDA ANDA040405 McKesson Contract Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 76237-515_1b613496-07ab-4e62-9e80-1dcebea58ed6 76237-515 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111005 ANDA ANDA040400 McKesson Contract Packaging ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII 76245-101_278a47b1-084b-47b8-8a58-e5bd85483d8f 76245-101 HUMAN OTC DRUG SK1N NATURAL SUNSCREEN SPF 20 ZINC OXIDE LOTION TOPICAL 19960101 OTC MONOGRAPH NOT FINAL part352 True Nature Group, Inc. ZINC OXIDE 19 g/142g 76245-102_c7175015-e944-452c-af7c-67e5e1d27330 76245-102 HUMAN OTC DRUG SK1N NATURAL SUNSCREEN SPF 40 ZINC OXIDE LOTION TOPICAL 19960101 OTC MONOGRAPH NOT FINAL part352 True Nature Group, Inc. ZINC OXIDE 25 g/142g 76245-216_d3dc37cd-b99c-4d88-8c4d-db7c55dddf43 76245-216 HUMAN OTC DRUG True Natural broad sptectum spf 50 Unscented face and sensitive skin ZINC OXIDE CREAM TOPICAL 20120312 OTC MONOGRAPH FINAL part347 True Nature Group, Inc. ZINC OXIDE 10 mL/50mL 76245-217_d893b899-abf8-4e47-af34-a76be7ab0445 76245-217 HUMAN OTC DRUG True Natural broad spectrum spf 50 all natural vanilla-coconut sunscreen ZINC OXIDE SPRAY TOPICAL 20120312 OTC MONOGRAPH FINAL part347 True Nature Group, Inc. ZINC OXIDE 24 mL/120mL 76245-218_0285e5bd-0b83-49f1-94e0-0760c647ff62 76245-218 HUMAN OTC DRUG True Natural broad spectrum spf 50 all natural vanilla-coconut sunscreen ZINC OXIDE LOTION TOPICAL 20120312 OTC MONOGRAPH FINAL part347 True Nature Group, Inc. ZINC OXIDE 20 mL/100mL 76245-219_17060d05-3987-4fd8-9399-17f7105453ab 76245-219 HUMAN OTC DRUG True Natural broad spectrum spf 50 all natural baby and sensitive skin sunscreen ZINC OXIDE LOTION TOPICAL 20120312 OTC MONOGRAPH FINAL part347 True Nature Group, Inc. ZINC OXIDE 20 mL/100mL 76245-220_c4262e75-f650-4038-97ea-9f348625103f 76245-220 HUMAN OTC DRUG True Natural broad spectrum spf 50 all natural sunscreen Limited Edition ZINC OXIDE CREAM TOPICAL 20120312 OTC MONOGRAPH FINAL part347 True Nature Group, Inc. ZINC OXIDE 10 mL/50mL 76250-110_f679c9ef-689d-4953-a6d2-f85e21787fc8 76250-110 HUMAN OTC DRUG E3 Foaming Hand Sanitizer Problend benzalkonium chloride LIQUID TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part333E Seatex Ltd BENZALKONIUM CHLORIDE 1 g/1000mL 76250-1195_f95e9652-ef11-4753-a393-ac948f859891 76250-1195 HUMAN OTC DRUG Antibacterial CHLOROXYLENOL SOAP TOPICAL 20110914 OTC MONOGRAPH NOT FINAL part333E Seatex Ltd CHLOROXYLENOL 40 g/kg 76250-123_266fc891-6cb4-4b54-b447-56ad6ce6ee2d 76250-123 HUMAN OTC DRUG Antibacterial CHLOROXYLENOL SOAP TOPICAL 20111014 OTC MONOGRAPH NOT FINAL part333E Seatex Ltd CHLOROXYLENOL 40 g/kg 76250-495_cd114f15-78fe-4c1d-a483-4cfbaff4d872 76250-495 HUMAN OTC DRUG Seatex Hand Sanitizer ISOPROPYL ALCOHOL GEL TOPICAL 20110701 OTC MONOGRAPH FINAL part344 Seatex Ltd ISOPROPYL ALCOHOL 700 g/kg 76250-595_63d97469-eabb-4623-922d-8c0b949b43d3 76250-595 HUMAN OTC DRUG Alcohol Hand Problend ISOPROPYL ALCOHOL GEL TOPICAL 20130809 OTC MONOGRAPH FINAL part344 Seatex Ltd ISOPROPYL ALCOHOL 700 mL/1000mL 76250-641_698eb99d-7661-44c2-a2d2-c18c4687a09f 76250-641 HUMAN OTC DRUG Alcohol Hand Sanitizer Problend ISOPROPYL ALCOHOL GEL TOPICAL 20130809 OTC MONOGRAPH FINAL part344 Seatex Ltd ISOPROPYL ALCOHOL 700 mL/1000mL 76250-786_f9a666d2-29e0-4918-8848-7ba188774e7f 76250-786 HUMAN OTC DRUG Antibacterial Hand Problend CHLOROXYLENOL SOAP TOPICAL 20110531 OTC MONOGRAPH NOT FINAL part333E Seatex Ltd CHLOROXYLENOL 4 g/1000mL 76250-995_4581e04a-bd9e-4989-bce1-3b8cf1d0b420 76250-995 HUMAN OTC DRUG Anti Bacterial Foam Hand Problend benzalkonium chloride SOAP TOPICAL 20120531 OTC MONOGRAPH NOT FINAL part333E Seatex Ltd BENZALKONIUM CHLORIDE 1.3 g/1000mL 76254-1001_def2c725-39ce-4f67-bcfd-0a9ce59ffd3a 76254-1001 HUMAN OTC DRUG Probee propolis PASTE, DENTIFRICE ORAL 20110810 UNAPPROVED DRUG OTHER Seoul Propolis PROPOLIS WAX 5 g/100g 76254-2001_cf5ec092-5e14-4852-9cde-c3ce6f18144b 76254-2001 HUMAN OTC DRUG Robongbang Propolis propolis CAPSULE ORAL 20110816 UNAPPROVED DRUG OTHER Seoul Propolis PROPOLIS WAX 85 mg/1 76254-3001_648756b1-2113-4fae-a21d-f2c40e308b43 76254-3001 HUMAN OTC DRUG Robongbang water soluble propolis propolis LIQUID ORAL 20110816 UNAPPROVED DRUG OTHER Seoul Propolis PROPOLIS WAX .364 mL/mL 76254-4001_e8f4de87-3563-491d-afd9-49fa34491923 76254-4001 HUMAN OTC DRUG Probee water soluble propolis propolis LIQUID ORAL 20110816 UNAPPROVED DRUG OTHER Seoul Propolis PROPOLIS WAX .329 mL/mL 76254-5001_64145159-4c6f-4b96-864a-d12ff32a47de 76254-5001 HUMAN OTC DRUG Seoul Propolia propolis LIQUID ORAL 20110816 UNAPPROVED DRUG OTHER Seoul Propolis PROPOLIS WAX .99 mL/mL 76255-1001_a9eb2e2a-f4e4-43e5-a7e5-50fc62232080 76255-1001 HUMAN OTC DRUG Volcano Power EUCOMMIA ULMOIDES CAPSULE ORAL 20110611 UNAPPROVED DRUG OTHER H&C 21 America Inc EUCOMMIA ULMOIDES BARK 54 mg/1 76255-2001_dd69ed67-5608-4dbd-9543-48734bef70f7 76255-2001 HUMAN OTC DRUG Letomint clove TABLET ORAL 20110618 UNAPPROVED DRUG OTHER H&C 21 America Inc CLOVE 18 mg/1 76260-101_1f924be6-18a8-4ea6-853e-22e5f661610b 76260-101 HUMAN OTC DRUG Aqua Maris Isotonised Sodium chloride LIQUID NASAL 20011228 UNAPPROVED DRUG OTHER JGL North America LLC SODIUM CHLORIDE 11.25 mg/mL 76260-102_d0a918a0-0a5b-4d58-9501-85c29bfbcbe8 76260-102 HUMAN OTC DRUG Aqua Maris Strong Sodium chloride SPRAY NASAL 20090318 UNAPPROVED HOMEOPATHIC JGL North America LLC SODIUM CHLORIDE 37.5 mg/mL 76260-103_eca045d7-e921-49ec-af67-2d4f68d717ae 76260-103 HUMAN OTC DRUG Aqua Maris Baby Sodium chloride LIQUID NASAL 20100708 UNAPPROVED DRUG OTHER JGL North America LLC SODIUM CHLORIDE 11.25 mg/mL 76260-104_467bad22-2fd7-4009-907e-165168607882 76260-104 HUMAN OTC DRUG Aqua Maris Ear Sodium Chloride SPRAY AURICULAR (OTIC) 20091029 UNAPPROVED DRUG OTHER JGL North America LLC SODIUM CHLORIDE 11.25 mg/mL 76260-105_5d386ab7-f2a7-410f-b6f1-9526361da8d7 76260-105 HUMAN OTC DRUG Aqua Maris Throat Sodium chloride SPRAY ORAL 20050420 UNAPPROVED DRUG OTHER JGL North America LLC SODIUM CHLORIDE 37.5 mg/mL 76260-106_b70ba985-2894-493f-a4cf-c9102fe36d97 76260-106 HUMAN OTC DRUG Aqua Maris Fast Acting Decongestant Xylometazoline HCL SPRAY NASAL 20121215 OTC MONOGRAPH FINAL part341 JGL North America LLC XYLOMETAZOLINE HYDROCHLORIDE 10 mg/10mL 76260-107_28ca2b5e-5642-46ca-9303-8e9a19bec60d 76260-107 HUMAN OTC DRUG Aqua Maris Kids Fast Acting Decongestant Xylometazoline HCL SPRAY NASAL 20100927 OTC MONOGRAPH FINAL part341 JGL North America LLC XYLOMETAZOLINE HYDROCHLORIDE .05 mg/10mL 76261-125_a14210e4-bfeb-461a-b6af-87946ec1cd8f 76261-125 HUMAN OTC DRUG ASAP Skin Products Moisturising Daily Defense SPF 30 Octocrylene,Zinc Oxide, Avobenzone, Ensulizone, Titanium Dioxide LOTION TOPICAL 20110603 OTC MONOGRAPH NOT FINAL part352 Australian Skin Products pty ltd AVOBENZONE; ENSULIZOLE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 2; 1.5; 6; 1; 2.75 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 76261-126_56f3b078-ed8d-4b8b-9214-43644b68b2b0 76261-126 HUMAN OTC DRUG correcting cream Broad Spectrum SPF 15 asap avobenzone, Octinoxate, Octocrylene, Oxybenzone, Zinc Oxide LOTION TOPICAL 20140804 OTC MONOGRAPH FINAL part352 AUSTRALIAN SKIN PRODUCTS PTY LTD AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 3; 4; 2.7; 3; 4.5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL 76261-127_76039001-5295-415d-9010-930f5019b7a7 76261-127 HUMAN OTC DRUG Hydrating Lip Balm SPF 15 sunscreen ASAP Avobenzone, Homosalate, Octocrylene, Octisalate GEL TOPICAL 20140807 OTC MONOGRAPH FINAL part352 AUSTRALIAN SKIN PRODUCTS PTY LTD AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3.5; 5; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL 76261-250_73e7910d-2bc1-4a68-8218-1b7994190391 76261-250 HUMAN OTC DRUG Sheer Tint Moisturizer SPF 15 ASAP Skin Products Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 AUSTRALIAN SKIN PRODUCTS PTY LTD TITANIUM DIOXIDE; ZINC OXIDE 4; 1 g/100mL; g/100mL 76267-060_fb817546-31ae-410a-812d-0e5ceafbf1dc 76267-060 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20121231 ANDA ANDA202710 Allied Pharma Inc CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 76267-061_fb817546-31ae-410a-812d-0e5ceafbf1dc 76267-061 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20121231 ANDA ANDA202710 Allied Pharma Inc CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 76267-150_cc42779d-9cf2-4dc5-a770-483c0ab7d976 76267-150 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20130602 ANDA ANDA203244 Allied Pharma Inc GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76267-151_cc42779d-9cf2-4dc5-a770-483c0ab7d976 76267-151 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20130602 ANDA ANDA203244 Allied Pharma Inc GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76268-001_d8bd636b-0010-4e50-b3a0-7956e0eb476f 76268-001 HUMAN OTC DRUG Antibacterial Hand Benzalkonium Chloride GEL TOPICAL 20110727 OTC MONOGRAPH NOT FINAL part333A ORGANICA (UK) LTD BENZALKONIUM CHLORIDE .1 mL/100mL 76268-002_c0035b50-75c2-46fd-a258-61b36e8eee58 76268-002 HUMAN OTC DRUG Antibacterial Hand Mousse Benzalkonium Chloride LIQUID TOPICAL 20110728 OTC MONOGRAPH NOT FINAL part333A ORGANICA (UK) LTD BENZALKONIUM CHLORIDE .13 mL/100mL 76269-187_e9c90ac7-88e3-48ed-a6ff-ebd6ae4ba642 76269-187 HUMAN OTC DRUG Lip Balm Vanilla SPF-15 Octinoxate, Oxybenzone OINTMENT TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 Teton Outfitters LLC dba Klim Aggressive Sledwear OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 76270-101_b8ad9828-410d-43d5-aebc-8ea15a4d6946 76270-101 HUMAN OTC DRUG STOOL SOFTENER GENTLE RELIEF DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH NOT FINAL part334 PuraVation Pharmaceuticals Inc DOCUSATE SODIUM 100 mg/1 76270-103_aff5dfcc-20a2-454b-8839-4699ac032ce9 76270-103 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20130915 OTC MONOGRAPH FINAL part332 PuraVation Pharmaceuticals Inc DIMETHICONE 125 mg/1 76270-104_496c2004-9787-4879-a1f9-7842e2debe59 76270-104 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH FINAL part347 PuraVation Pharmaceuticals Inc DIMETHICONE 180 mg/1 76270-106_02cef47e-42b7-446a-bc81-3ab3406d5942 76270-106 HUMAN OTC DRUG NITE TIME COLD AND FLU acetaminophen, dextromethorphan hydrobromide, doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH FINAL part341 PuraVation Pharmaceuticals Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 76270-108_1c33f87a-9ed5-4bc0-8ff0-8f72edb6531c 76270-108 HUMAN OTC DRUG DYE-FREE ALLERGY RELIEF DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20130912 OTC MONOGRAPH FINAL part336 PuraVation Pharmaceuticals Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 76270-109_e93aca52-10ac-4cc6-9952-33491d8b4d03 76270-109 HUMAN OTC DRUG NIGHTTIME SLEEP AID DIPHENHYDRAMINE HYDROCHLORIDE 50 mg CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH FINAL part341 PuraVation Pharmaceuticals Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 76270-113_14098a32-358e-4db0-8cab-f98ce2e62bdb 76270-113 HUMAN OTC DRUG NON-DROWSY DAYTIME SINUS RELIEF acetaminophen, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20130915 OTC MONOGRAPH FINAL part341 PuraVation Pharmaceuticals Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 76270-114_72108487-8914-4462-bfd5-794ab52654a7 76270-114 HUMAN OTC DRUG Multi-Symptom Nighttime Sinus Relief Acetaminophen, Doxylamine succinate, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20130915 OTC MONOGRAPH FINAL part341 PuraVation Pharmaceuticals Inc ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 76270-116_25ddc785-b5ac-41e4-b700-d3443c3648c6 76270-116 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM 50 MG DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131112 OTC MONOGRAPH NOT FINAL part334 PuraVation Pharmaceuticals Inc DOCUSATE SODIUM 50 mg/1 76270-150_bf08f3ab-7641-4e67-b49f-afda7d1f9dda 76270-150 HUMAN OTC DRUG SLEEP AID DIPHENHYDRAMINE HYDROCHLORIDE 25 mg CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH FINAL part341 PuraVation Pharmaceuticals Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 76271-001_c6e98d27-268e-4ab6-98d6-746b45d4c56c 76271-001 HUMAN OTC DRUG DR. WALTONS BABY POWDER TALC POWDER TOPICAL 20110709 OTC MONOGRAPH NOT FINAL part347 Dr. Waltons, Incorporated ALPHA-TOCOPHEROL; ZINC OXIDE 5.2; 5.13 g/675g; g/675g 76271-002_d5c05f56-3b4d-487b-9cb3-fdd0651d6a06 76271-002 HUMAN OTC DRUG DR WALTONS PETROLEUM PETROLATUM JELLY TOPICAL 20110709 OTC MONOGRAPH FINAL part346 Dr. Waltons, Incorporated PETROLATUM 226 g/226g 76271-003_936924f1-0689-445f-99a7-ac3dd7372b06 76271-003 HUMAN OTC DRUG DR. WALTONS COOL AND HOT ANALGESIC MENTHOL GEL TOPICAL 20110714 OTC MONOGRAPH FINAL part346 DR. WALTONS, INCORPORATED MENTHOL 2.27 g/227g 76271-004_84149f61-14f9-44af-b3c3-6dec83130e07 76271-004 HUMAN OTC DRUG DR WALTONS VAPOR RUB VAPOR RUB GEL TOPICAL 20110714 OTC MONOGRAPH FINAL part346 DR. WALTONS, INCORPORATED CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 5.3; 1.13; 2.26 g/113g; g/113g; g/113g 76273-001_b36e8ab8-cb05-4d04-951e-7722b38a00bd 76273-001 HUMAN OTC DRUG Antibacterial Hand BENZALKONIUM CHLORIDE GEL TOPICAL 20110727 OTC MONOGRAPH NOT FINAL part333A MAYBORN USA, INC. BENZALKONIUM CHLORIDE .1 mL/100mL 76273-002_2d1ede75-60b2-4614-9013-85d33ee09baa 76273-002 HUMAN OTC DRUG Antibacterial Hand Mousse BENZALKONIUM CHLORIDE LIQUID TOPICAL 20110728 OTC MONOGRAPH NOT FINAL part333A MAYBORN USA, INC. BENZALKONIUM CHLORIDE .13 mL/100mL 76277-100_c00e2ed3-d977-4ad6-8242-1f7005d60b7e 76277-100 HUMAN OTC DRUG OCUMEND Arnica Montana, Ledum Palustre PELLET ORAL 20120101 UNAPPROVED HOMEOPATHIC Cearna, Inc. ARNICA MONTANA; LEDUM PALUSTRE TWIG 50; 50 [hp_M]/1; [hp_M]/1 76277-211_28f09ade-a67b-4c93-a857-7aece06b3ee6 76277-211 HUMAN OTC DRUG OcuMend Arnica Montana, Ledum Palustre KIT 20120517 UNAPPROVED HOMEOPATHIC Cearna, Inc. 76277-612_b459c3dd-79a2-4852-9570-92174f495589 76277-612 HUMAN OTC DRUG OcuMend Healing Gels Arnica Montana, Ledum Palustre PATCH TOPICAL 20120501 UNAPPROVED HOMEOPATHIC Cearna, Inc. ARNICA MONTANA; LEDUM PALUSTRE TWIG 50; 50 [hp_M]/1; [hp_M]/1 76279-420_72af2948-94c6-4db2-90b3-698291b6f118 76279-420 HUMAN OTC DRUG Softone Luxury Foam Antibacterial Skin Cleanser Triclosan SOLUTION TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part333E Brady Industries LLC TRICLOSAN 5 g/L 76280-231_c21be104-1535-49c0-8ec3-8859b67da5f8 76280-231 HUMAN OTC DRUG Octisalate, Avobenzone, Homosalate, Octocrylene SPF30 Julep Solace Oil-Free Sunscreen Broad Spectrum LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Julep Nail Parlor AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 2.7 g/89mL; g/89mL; g/89mL; g/89mL 76280-232_203701d9-0a3c-4322-83e1-9f60bd488375 76280-232 HUMAN OTC DRUG Octisalate, Avobenzone, Homosalate, Octocrylene SPF30 Julep Time Machine KIT TOPICAL 20130910 OTC MONOGRAPH NOT FINAL part352 Julep Nail Parlor 76281-301_658d8d06-b4b9-49a5-9f32-d5a22033bc59 76281-301 HUMAN OTC DRUG Childrens Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20130821 OTC MONOGRAPH FINAL part341 AptaPharma Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL 76281-302_0fa300f5-d15a-4ad7-874e-d4a0bc6a1b94 76281-302 HUMAN OTC DRUG Childrens Pain and Fever ACETAMINOPHEN LIQUID ORAL 20130821 OTC MONOGRAPH NOT FINAL part343 AptaPharma Inc. ACETAMINOPHEN 160 mg/5mL 76282-200_604ec2bb-cbe4-4688-b23d-785cbb465c19 76282-200 HUMAN PRESCRIPTION DRUG Fosinopril sodium Fosinopril sodium TABLET ORAL 20050621 ANDA ANDA077222 Exelan Pharmaceuticals, Inc. FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76282-201_604ec2bb-cbe4-4688-b23d-785cbb465c19 76282-201 HUMAN PRESCRIPTION DRUG Fosinopril sodium Fosinopril sodium TABLET ORAL 20050621 ANDA ANDA077222 Exelan Pharmaceuticals, Inc. FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76282-202_604ec2bb-cbe4-4688-b23d-785cbb465c19 76282-202 HUMAN PRESCRIPTION DRUG Fosinopril sodium Fosinopril sodium TABLET ORAL 20050621 ANDA ANDA077222 Exelan Pharmaceuticals, Inc. FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76282-206_ae237968-36dd-4ca0-b521-a8fca64d08a6 76282-206 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM TABLET ORAL 20121001 ANDA ANDA077534 Exelan Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76282-207_ae237968-36dd-4ca0-b521-a8fca64d08a6 76282-207 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM TABLET ORAL 20121001 ANDA ANDA077534 Exelan Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76282-208_ae237968-36dd-4ca0-b521-a8fca64d08a6 76282-208 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM TABLET ORAL 20121001 ANDA ANDA077534 Exelan Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76282-209_6dc279cc-9861-4fa8-8083-ca3b3c57b513 76282-209 HUMAN PRESCRIPTION DRUG Terbinafine Terbinafine TABLET ORAL 20120425 ANDA ANDA077533 Exelan Pharmaceuticals Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] 76282-210_067aaa4f-6e77-44d4-a648-df1c2611e730 76282-210 HUMAN PRESCRIPTION DRUG FOLIC ACID FOLIC ACID TABLET ORAL 20100406 ANDA ANDA090035 Exelan Pharmaceuticals, Inc. FOLIC ACID 1 mg/1 76282-212_ab94fd4c-09d0-424f-9810-560b97c0fc20 76282-212 HUMAN PRESCRIPTION DRUG SERTRALINE Sertraline TABLET, FILM COATED ORAL 20120820 ANDA ANDA077397 Exelan Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76282-213_ab94fd4c-09d0-424f-9810-560b97c0fc20 76282-213 HUMAN PRESCRIPTION DRUG SERTRALINE Sertraline TABLET, FILM COATED ORAL 20120820 ANDA ANDA077397 Exelan Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76282-214_ab94fd4c-09d0-424f-9810-560b97c0fc20 76282-214 HUMAN PRESCRIPTION DRUG SERTRALINE Sertraline TABLET, FILM COATED ORAL 20120820 ANDA ANDA077397 Exelan Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76282-225_c00c79b0-4127-4d16-b956-e68da794df57 76282-225 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20061020 ANDA ANDA077836 Exelan Pharmaceuticals, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] 76282-228_24284954-0c29-458f-a9f8-97a7ad418ca7 76282-228 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20060705 ANDA ANDA077869 Exelan Pharmaceuticals, Inc. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76282-237_efd9eda5-f497-45a3-ae13-dee729add999 76282-237 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20071102 ANDA ANDA077955 Exelan Pharmaceuticals, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 76282-238_efd9eda5-f497-45a3-ae13-dee729add999 76282-238 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20071102 ANDA ANDA077955 Exelan Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 76282-239_efd9eda5-f497-45a3-ae13-dee729add999 76282-239 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20071102 ANDA ANDA077955 Exelan Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] 76282-246_28c0e61e-1af9-410a-9fa9-b71bf99a776b 76282-246 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078234 Exelan Pharmaceuticals, Inc. LEVETIRACETAM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76282-247_28c0e61e-1af9-410a-9fa9-b71bf99a776b 76282-247 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078234 Exelan Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76282-248_28c0e61e-1af9-410a-9fa9-b71bf99a776b 76282-248 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078234 Exelan Pharmaceuticals, Inc. LEVETIRACETAM 750 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76282-249_72431695-3c65-4206-8187-4c86af3fd57d 76282-249 HUMAN PRESCRIPTION DRUG Escitalopram oxalate escitalopram TABLET, FILM COATED ORAL 20121001 ANDA ANDA078604 Exelan Pharmaceuticals Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76282-250_72431695-3c65-4206-8187-4c86af3fd57d 76282-250 HUMAN PRESCRIPTION DRUG Escitalopram oxalate escitalopram TABLET, FILM COATED ORAL 20121001 ANDA ANDA078604 Exelan Pharmaceuticals Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76282-251_72431695-3c65-4206-8187-4c86af3fd57d 76282-251 HUMAN PRESCRIPTION DRUG Escitalopram oxalate escitalopram TABLET, FILM COATED ORAL 20121001 ANDA ANDA078604 Exelan Pharmaceuticals Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76282-256_cfc5eee1-98e1-4afa-afa9-890989713c4a 76282-256 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET, FILM COATED ORAL 20141112 ANDA ANDA090842 Exelan Pharmaceuticals, Inc. RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] 76282-257_47b9ce83-9be8-4e5b-8c9e-84a734db0028 76282-257 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20140315 ANDA ANDA078671 Exelan Pharmaceuticals Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 76282-258_47b9ce83-9be8-4e5b-8c9e-84a734db0028 76282-258 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20140315 ANDA ANDA078671 Exelan Pharmaceuticals Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 76282-271_2e6303e8-1c22-451f-8733-a55e237ff961 76282-271 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080627 ANDA ANDA078745 Exelan Pharmaceuticals, Inc. RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76282-272_2e6303e8-1c22-451f-8733-a55e237ff961 76282-272 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080627 ANDA ANDA078745 Exelan Pharmaceuticals, Inc. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76282-273_2e6303e8-1c22-451f-8733-a55e237ff961 76282-273 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080627 ANDA ANDA078745 Exelan Pharmaceuticals, Inc. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76282-274_2e6303e8-1c22-451f-8733-a55e237ff961 76282-274 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080627 ANDA ANDA078745 Exelan Pharmaceuticals, Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76282-302_99248cfc-084e-4a1a-97f2-6a4ab2cdd3ad 76282-302 HUMAN PRESCRIPTION DRUG Alfuzosin hydrochloride Alfuzosin hydrochloride TABLET, EXTENDED RELEASE ORAL 20121002 ANDA ANDA090284 Exelan Pharmaceuticals Inc. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] 76282-321_38005734-2fc0-4f9e-bf7f-eab5d6c9be75 76282-321 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20100426 ANDA ANDA090705 Exelan Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76282-322_38005734-2fc0-4f9e-bf7f-eab5d6c9be75 76282-322 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20100426 ANDA ANDA090705 Exelan Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76282-323_38005734-2fc0-4f9e-bf7f-eab5d6c9be75 76282-323 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20100426 ANDA ANDA090705 Exelan Pharmaceuticals, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76282-377_f055ad87-1683-4d1a-970f-e1b0ffaecb6e 76282-377 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20140414 ANDA ANDA203135 Exelan Pharmaceuticals, Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 76282-405_323dad14-ded9-4432-a265-c957e46cc6db 76282-405 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin TABLET, FILM COATED ORAL 20121102 ANDA ANDA202764 Exelan Pharmaceuticals Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76282-406_323dad14-ded9-4432-a265-c957e46cc6db 76282-406 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin TABLET, FILM COATED ORAL 20121102 ANDA ANDA202764 Exelan Pharmaceuticals Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] 76282-412_25d2fc9a-f095-4937-bdc0-80a9670ba5ed 76282-412 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20130917 ANDA ANDA090061 Exelan Pharmaceuticals Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] 76282-417_bcfc48dc-8900-4f28-8221-a4c0515eff0e 76282-417 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140315 ANDA ANDA203508 Exelan Pharmaceuticals Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76282-418_bcfc48dc-8900-4f28-8221-a4c0515eff0e 76282-418 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140315 ANDA ANDA203508 Exelan Pharmaceuticals Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76282-419_bcfc48dc-8900-4f28-8221-a4c0515eff0e 76282-419 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140315 ANDA ANDA203508 Exelan Pharmaceuticals Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76282-420_bcfc48dc-8900-4f28-8221-a4c0515eff0e 76282-420 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140315 ANDA ANDA203508 Exelan Pharmaceuticals Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76282-421_bcfc48dc-8900-4f28-8221-a4c0515eff0e 76282-421 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140315 ANDA ANDA203508 Exelan Pharmaceuticals Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76282-422_bcfc48dc-8900-4f28-8221-a4c0515eff0e 76282-422 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140315 ANDA ANDA203508 Exelan Pharmaceuticals Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] 76284-001_f0abfebd-a1bc-4b43-94f2-07acb3933173 76284-001 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20110627 OTC MONOGRAPH FINAL part344 Ningbo Timedo Medical Supply Co.,Ltd. ISOPROPYL ALCOHOL .7 mL/1 76284-002_cc74e6a6-caca-4cd2-8c35-bb3f803c26c0 76284-002 HUMAN OTC DRUG Alcohol Cotton Ball ISOPROPYL ALCOHOL SWAB TOPICAL 20110629 OTC MONOGRAPH FINAL part344 Ningbo Timedo Medical Supply Co.,Ltd. ISOPROPYL ALCOHOL .7 mL/1 76287-576_843a31ee-0551-48de-8b61-fdc84bc4bf87 76287-576 HUMAN OTC DRUG FresHands TRICLOSAN SOAP TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333E Spa Concepts, Inc. TRICLOSAN 3 mg/mL 76290-001_059763f6-72bd-4588-a239-88579c6d70e6 76290-001 HUMAN OTC DRUG Seven Skin Healing and Moisturizing Calendula officinalis CREAM TOPICAL 20111121 UNAPPROVED HOMEOPATHIC Robin Logan Consulting CALENDULA OFFICINALIS FLOWER 1.2 mL/60mL 76293-015_dc185d05-bca1-465b-a06a-9247d36683b2 76293-015 HUMAN OTC DRUG Avail Body with Sunscreen Homosalate, Octocrylene, Octisalate, and Avobenzone LOTION TOPICAL 20141104 OTC MONOGRAPH FINAL part352 Emeis Cosmetics Pty Ltd AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1050; 3500; 1750; 2800 mg/35g; mg/35g; mg/35g; mg/35g 76293-037_3a947dd1-5147-4c62-9b0c-8dc8b18f3fb4 76293-037 HUMAN OTC DRUG Sage And Zinc Facial Hydrating SPF 15 Zinc Oxide CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Emeis Cosmetics Pty Ltd ZINC OXIDE .26 g/1.54g 76293-052_33cb261d-b49a-47d6-af07-2ad96fce14b9 76293-052 HUMAN OTC DRUG Avail Lip Balm with Sunscreen Zinc Oxide and Octocrylene STICK TOPICAL 20131201 OTC MONOGRAPH FINAL part352 Emeis Cosmetics Pty Ltd OCTOCRYLENE; ZINC OXIDE .00047; .00058 g/.011g; g/.011g 76296-005_1a2ee757-9305-49fe-a0c8-241f7450f593 76296-005 HUMAN OTC DRUG VINOPERFECT BROAD SPECTRUM SPF 15 DAY PERFECTING AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20120607 OTC MONOGRAPH FINAL part352 Caudalie USA Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 39.96; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL 76296-006_5960c203-c4c6-425c-a734-347b78ba2437 76296-006 HUMAN OTC DRUG VINOPERFECT BROAD SPECTRUM SPF 15 DAY PERFECTING FLUID AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LIQUID TOPICAL 20120608 OTC MONOGRAPH FINAL part352 Caudalie USA Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 39.96; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL 76296-007_27ec6474-ec96-4c86-8b8d-b622b61f7bbb 76296-007 HUMAN OTC DRUG VINEXPERT BROAD SPECTRUM SPF 15 RADIANCE DAY AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20120621 OTC MONOGRAPH FINAL part352 Caudalie USA Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 3.996; 5; 8 mL/100mL; mL/100mL; mL/100mL; mL/100mL 76296-008_312160c1-9aaa-4864-898e-7b92774af364 76296-008 HUMAN OTC DRUG VINEXPERT BROAD SPECTRUM SPF 15 RADIANCE DAY FLUID AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LIQUID TOPICAL 20120621 OTC MONOGRAPH FINAL part352 Caudalie USA Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 3.996; 5; 8 mL/100mL; mL/100mL; mL/100mL; mL/100mL 76296-009_d713e7e2-a168-4b6c-8a16-6f19b70dda41 76296-009 HUMAN OTC DRUG POLYPHENOL C15 BROAD SPECTRUM SPF20 ANTI-WRINKLE PROTECT FLUID AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LIQUID TOPICAL 20140102 OTC MONOGRAPH NOT FINAL part352 Caudalie USA Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 40; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL 76296-010_5d5cc019-2ac2-4b0e-8a1e-eb8942744cd8 76296-010 HUMAN OTC DRUG VINOPERFECT BROAD SPECTRUM SPF 15 DAY PERFECTING FLUID AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Caudalie USA Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 39.96; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL 76296-011_b5b65d91-68a7-431d-b29a-db6a80f10490 76296-011 HUMAN OTC DRUG Radiance Tinted Moisturizer Broad Spectrum SPF20 Light OCTINOXATE CREAM TOPICAL 20141129 OTC MONOGRAPH NOT FINAL part352 Caudalie USA Inc. OCTINOXATE 70 mg/mL 76296-012_d974c79a-f544-42ad-9725-88bb934b800e 76296-012 HUMAN OTC DRUG Radiance Tinted Moisturizer Broad Spectrum SPF20 Medium 02 OCTINOXATE CREAM TOPICAL 20141129 OTC MONOGRAPH NOT FINAL part352 Caudalie USA Inc. OCTINOXATE 70 mg/mL 76299-420_10b9e464-63f7-43c6-9f85-88f1dc2daa7f 76299-420 HUMAN PRESCRIPTION DRUG INDERAL XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140201 NDA NDA021438 Mist Pharmaceuticals, LLC PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 76299-422_10b9e464-63f7-43c6-9f85-88f1dc2daa7f 76299-422 HUMAN PRESCRIPTION DRUG INDERAL XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140201 NDA NDA021438 Mist Pharmaceuticals, LLC PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 76305-300_d003e69b-358b-4021-a37b-4ed8e297d60b 76305-300 HUMAN OTC DRUG China-Gel Topical Pain Reliever Menthol and Camohor (synthetic) CREAM TOPICAL 20000819 OTC MONOGRAPH NOT FINAL part348 China-Gel, Inc. CAMPHOR (SYNTHETIC); MENTHOL 30; 50 mg/g; mg/g 76308-001_e2106329-5ca2-4274-9fe4-46e888ee08f8 76308-001 HUMAN OTC DRUG Hand Sanitizer ETHANOL GEL TOPICAL 20110905 OTC MONOGRAPH NOT FINAL part333E Just Play, LLC ALCOHOL 600 mL/1000mL 76310-001_54da98d1-fae2-4cce-b322-99dd3ad465f3 76310-001 HUMAN PRESCRIPTION DRUG Foscavir UK foscarnet sodium INJECTION, SOLUTION INTRAVENOUS 20100922 20150101 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Clinigen Healthcare Ltd. FOSCARNET SODIUM 24 mg/mL DNA Polymerase Inhibitors [MoA],Pyrophosphate Analog [Chemical/Ingredient],Pyrophosphate Analog DNA Polymerase Inhibitor [EPC] 76310-024_088a873a-be77-4f2a-9e97-2aaa8949b868 76310-024 HUMAN PRESCRIPTION DRUG Foscavir foscarnet sodium INJECTION, SOLUTION INTRAVENOUS 20140401 NDA NDA020068 Clinigen Healthcare Ltd. FOSCARNET SODIUM 24 mg/mL DNA Polymerase Inhibitors [MoA],Pyrophosphate Analog [Chemical/Ingredient],Pyrophosphate Analog DNA Polymerase Inhibitor [EPC] 76310-024_88e208bb-8404-4a3e-91e4-e23a4fb3b4a3 76310-024 HUMAN PRESCRIPTION DRUG Foscavir foscarnet sodium INJECTION, SOLUTION INTRAVENOUS 20120709 NDA NDA020068 Clinigen Healthcare Ltd. FOSCARNET SODIUM 24 mg/mL DNA Polymerase Inhibitors [MoA],Pyrophosphate Analog [Chemical/Ingredient],Pyrophosphate Analog DNA Polymerase Inhibitor [EPC] 76312-001_18da1eae-4f67-40fd-a59f-ba3c1527bf75 76312-001 HUMAN OTC DRUG TriCalm Hydrogel Aluminum Acetate GEL TOPICAL 20131101 OTC MONOGRAPH FINAL part347 Cosmederm Bioscience ALUMINUM ACETATE 2 mg/mL 76314-001_6b6af266-629f-4f94-bfb3-9dd77dbbad0b 76314-001 HUMAN OTC DRUG FixMySkin Healing Balm Vanilla Fragrance HYDROCORTISONE OINTMENT TOPICAL 20111117 OTC MONOGRAPH FINAL part348 Lovely Skin, Inc HYDROCORTISONE 1 mL/100mL 76314-002_3ad55f6c-ad6b-42ee-8c97-1f805cdfe676 76314-002 HUMAN OTC DRUG FixMySkin Healing Balm Fragrance-Free HYDROCORTISONE OINTMENT TOPICAL 20111117 OTC MONOGRAPH FINAL part348 Lovely Skin, Inc. HYDROCORTISONE 1 mL/100mL 76314-003_ae2d43f9-3f1c-4b03-9978-bc77545c7be7 76314-003 HUMAN OTC DRUG FixMySkin Healing Balm Unflavored HYDROCORTISONE OINTMENT TOPICAL 20111117 OTC MONOGRAPH FINAL part348 Lovely Skin, Inc. HYDROCORTISONE 1 mL/100mL 76314-004_df20bfb1-659e-4896-bfb2-e478f8ae6ecb 76314-004 HUMAN OTC DRUG FixMySkin Healing Balm Vanilla Flavor HYDROCORTISONE OINTMENT TOPICAL 20111117 OTC MONOGRAPH FINAL part348 Lovely Skin, Inc. HYDROCORTISONE 1 mL/100mL 76318-334_6d7074ec-601b-4ab1-9609-c6474695dcad 76318-334 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F-18 INJECTION, SOLUTION INTRAVENOUS 20111030 ANDA ANDA204333 The General Hospital Corporation FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 76323-001_bc4ae8ec-66cb-40ff-8eaa-e01b07710e1f 76323-001 HUMAN OTC DRUG PF ANTI-BACTERIAL HAND SANITIZING WIPES BENZALKONIUM CHLORIDE LIQUID TOPICAL 20110701 OTC MONOGRAPH FINAL part333E Premium Formulations LLC BENZALKONIUM CHLORIDE .12 g/100g 76323-002_eb9309a0-d7ce-4c69-9187-3cafd8983de5 76323-002 HUMAN OTC DRUG PF ANTI-BACTERIAL HAND SANITIZING WIPES BENZALKONIUM CHLORIDE LIQUID TOPICAL 20110701 OTC MONOGRAPH FINAL part333E Premium Formulations LLC BENZALKONIUM CHLORIDE .12 g/100g 76323-003_31912690-bc61-4a1f-8a38-db15dd7b9e63 76323-003 HUMAN OTC DRUG PF ANTI-BACTERIAL HAND SANITIZING WIPES BENZALKONIUM CHLORIDE LIQUID TOPICAL 20110701 OTC MONOGRAPH FINAL part333E Premium Formulations LLC BENZALKONIUM CHLORIDE .12 g/100g 76323-004_e1e6efb5-54dd-4948-9741-3636d79330e5 76323-004 HUMAN OTC DRUG PF FOAMING ANTI-BACTERIAL HAND SANITIZING BENZALKONIUM CHLORIDE SOAP TOPICAL 20110701 OTC MONOGRAPH FINAL part333E Premium Formulations LLC BENZALKONIUM CHLORIDE .12 mL/100mL 76323-005_a00b372c-a174-42cc-992a-ec6603710e4b 76323-005 HUMAN OTC DRUG PF HAND SANITIZING ETHYL ALCOHOL SPRAY TOPICAL 20110701 OTC MONOGRAPH FINAL part333E Premium Formulations LLC ALCOHOL 70 mL/100mL 76325-100_e3f10bc0-6ed9-11e2-bcfd-0800200c9a66 76325-100 HUMAN PRESCRIPTION DRUG Ravicti glycerol phenylbutyrate LIQUID ORAL 20130228 NDA NDA203284 Hyperion Therapeutics, Inc. GLYCEROL PHENYLBUTYRATE 1.1 g/mL 76325-188_7aa6525f-32e0-40e8-88af-b5cfaa1a2039 76325-188 HUMAN PRESCRIPTION DRUG Buphenyl sodium phenylbutyrate POWDER ORAL 19960430 NDA NDA020573 Hyperion Therapeutics, Inc. SODIUM PHENYLBUTYRATE .94 g/g Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] 76325-496_7aa6525f-32e0-40e8-88af-b5cfaa1a2039 76325-496 HUMAN PRESCRIPTION DRUG BUPHENYL sodium phenylbutyrate TABLET ORAL 19960513 NDA NDA020572 Hyperion Therapeutics, Inc. SODIUM PHENYLBUTYRATE 500 mg/1 Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] 76328-100_7c50a663-7866-40c9-a293-7d4a0cc12153 76328-100 HUMAN OTC DRUG Ancient Secrets Breathe Again Sodium Chloride AEROSOL, SPRAY NASAL 20110815 OTC MONOGRAPH FINAL part349 LOTUS BRANDS, INC. SODIUM CHLORIDE 20 mg/100mL 76328-101_879336d3-14c7-45dd-9b92-c02c4fecb542 76328-101 HUMAN OTC DRUG Ancient Secrets Breathe Again Childrens Sodium Chloride AEROSOL, SPRAY NASAL 20110815 OTC MONOGRAPH FINAL part349 LOTUS BRANDS, INC. SODIUM CHLORIDE 20 mg/100mL 76328-221_22e86631-5490-4842-9d75-48e7b511accd 76328-221 HUMAN OTC DRUG EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon SODIUM BICARBONATE LIQUID ORAL 20130601 OTC MONOGRAPH NOT FINAL part356 Lotus Brands, Inc. SODIUM BICARBONATE 25 mg/mL 76328-222_2236e496-e8e4-4185-8fc6-193fe92fcbc8 76328-222 HUMAN OTC DRUG EcoDent Res-Q-Dent Potassium Nitrate PASTE ORAL 20130601 OTC MONOGRAPH NOT FINAL part356 Lotus Brands, Inc. POTASSIUM NITRATE 50 mg/g 76328-223_52dd9942-cdea-483f-9f23-028d3bc2f7ad 76328-223 HUMAN OTC DRUG EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint SODIUM BICARBONATE LIQUID ORAL 20130601 OTC MONOGRAPH NOT FINAL part356 Lotus Brands, Inc. SODIUM BICARBONATE 25 mg/mL 76328-332_978ed130-1e60-4a98-a64f-ac2530eebeca 76328-332 HUMAN OTC DRUG Beauty Without Cruelty - Broad Spectrum SPF 30 ZINC OXIDE LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Lotus Brands, Inc. ZINC OXIDE 200 mg/mL 76328-333_b7db9261-84b7-48fa-9ed8-64af6fbd7ede 76328-333 HUMAN OTC DRUG Beauty Without Cruelty - Broad Spectrum SPF 18 OCTISALATE, AVOBENZONE, and OCTOCRYLENE LOTION TOPICAL 20130601 OTC MONOGRAPH FINAL part352 Lotus Brands, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 25; 50; 50 mg/mL; mg/mL; mg/mL 76328-334_76092920-80c6-4cf1-ad8b-856b55755768 76328-334 HUMAN OTC DRUG Beauty Without Cruelty - Broad Spectrum SPF 17 Vitamin C with CoQ10 ZINC OXIDE LOTION TOPICAL 20130601 OTC MONOGRAPH FINAL part352 Lotus Brands, Inc. ZINC OXIDE 140 mg/mL 76329-1240_1043c307-03e2-4725-93cf-55902c525b35 76329-1240 HUMAN PRESCRIPTION DRUG Phytonadione Phytonadione INJECTION, EMULSION PARENTERAL 20030418 ANDA ANDA083722 International Medication Systems, Limited PHYTONADIONE 1 mg/.5mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] 76329-1469_ad380cb1-fecb-47a5-a8d8-2e70803aabdc 76329-1469 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION PARENTERAL 19880401 ANDA ANDA072076 International Medication Systems, Limited NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 76329-1911_af10412b-a481-47f1-9ff8-d03e49ce5170 76329-1911 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAVENOUS 19870327 UNAPPROVED DRUG OTHER International Medication Systems, Limited MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII 76329-3011_64725ea9-d14b-4fc8-9128-a990223634cf 76329-3011 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 International Medication Systems, Limited LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 76329-3012_64725ea9-d14b-4fc8-9128-a990223634cf 76329-3012 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 International Medication Systems, Limited LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 76329-3013_64725ea9-d14b-4fc8-9128-a990223634cf 76329-3013 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 International Medication Systems, Limited LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 76329-3015_64725ea9-d14b-4fc8-9128-a990223634cf 76329-3015 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 International Medication Systems, Limited LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 76329-3301_3770a5fc-b58f-4c84-9670-46c2e57c9ddf 76329-3301 HUMAN PRESCRIPTION DRUG Dextrose Monohydrate Dextrose Monohydrate INJECTION PARENTERAL 20000601 UNAPPROVED DRUG OTHER International Medication Systems, Limited DEXTROSE MONOHYDRATE 250 mg/mL 76329-3304_b0599926-bad9-4374-990f-73e6c59a98db 76329-3304 HUMAN PRESCRIPTION DRUG Calcium Chloride Calcium Chloride INJECTION INTRAVENOUS; INTRAVENTRICULAR 19730501 UNAPPROVED DRUG OTHER International Medication Systems, Limited CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 76329-3316_dc99c577-4492-4e9f-ace8-cadb9d202b5e 76329-3316 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION INTRACARDIAC; INTRAVENOUS 19761201 UNAPPROVED DRUG OTHER International Medication Systems, Limited EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 76329-3339_9e04b177-41ee-46ed-8d52-dc943dad032c 76329-3339 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION PARENTERAL 20000601 UNAPPROVED DRUG OTHER International Medication Systems, Limited ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] 76329-3352_10566f6f-fe55-41e5-94b1-36e796c26529 76329-3352 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION INTRAVENOUS 20000601 UNAPPROVED DRUG OTHER International Medication Systems, Limited SODIUM BICARBONATE 84 mg/mL 76329-3369_ad380cb1-fecb-47a5-a8d8-2e70803aabdc 76329-3369 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION PARENTERAL 20010601 ANDA ANDA072076 International Medication Systems, Limited NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] 76329-3390_819afa93-34ba-45da-8960-b6b080feee27 76329-3390 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION INTRAVENOUS 20010601 ANDA ANDA083173 International Medication Systems, Limited LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 76329-6300_ee76dc23-4128-445d-bbd6-9148f1477467 76329-6300 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION TOPICAL 20120619 ANDA ANDA086364 International Medication Systems, Limited LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 76329-8251_2d329975-1e6b-4e03-87d3-b8fb74f113a2 76329-8251 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 20121201 ANDA ANDA076150 International Medication Systems, Limited LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 76329-8261_2d329975-1e6b-4e03-87d3-b8fb74f113a2 76329-8261 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 20121201 ANDA ANDA076150 International Medication Systems, Limited LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 76329-9061_440456fe-0bb9-4ac1-b6d3-99c3167a4888 76329-9061 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION PARENTERAL 20000701 UNAPPROVED DRUG OTHER International Medication Systems, Limited EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] 76330-100_eef48335-b1b4-431c-8c73-09171d9eba10 76330-100 HUMAN OTC DRUG Bum Ease Zinc Oxide LIQUID TOPICAL 20110701 OTC MONOGRAPH FINAL part347 Wake Innovation, LLC ZINC OXIDE 10 g/100mL 76331-807_67a0880b-c11c-43e8-ba6f-0a8bf56861eb 76331-807 HUMAN PRESCRIPTION DRUG Duet DHA .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, IRON, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, IODINE, OMEGA-3 FATTY ACIDS KIT ORAL 20110909 UNAPPROVED DRUG OTHER WH Nutritionals, LLC 76331-808_75b7cd4d-09b8-4e09-b179-853d55ccf238 76331-808 HUMAN PRESCRIPTION DRUG Duet DHA .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, IRON, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, IODINE, OMEGA-3 FATTY ACIDS KIT ORAL 20110909 UNAPPROVED DRUG OTHER WH Nutritionals, LLC 76331-809_36314732-1eac-4720-8a34-aeee9d70c869 76331-809 HUMAN PRESCRIPTION DRUG Duet DHA .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, IRON, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, IODINE, OMEGA-3 FATTY ACIDS KIT ORAL 20110909 UNAPPROVED DRUG OTHER WH Nutritionals, LLC 76331-810_8f760271-1b05-42cb-8304-ff9c1be51877 76331-810 HUMAN PRESCRIPTION DRUG Duet DHA .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, IRON, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, IODINE, OMEGA-3 FATTY ACIDS KIT ORAL 20110909 UNAPPROVED DRUG OTHER WH Nutritionals, LLC 76331-900_4f619836-f77d-433a-b8db-2a08b6e3fdde 76331-900 HUMAN PRESCRIPTION DRUG HEMETAB FOLIC ACID, CYANOCOBALAMIN, IRON SUCROSE, HEME IRON POLYPEPTIDE TABLET ORAL 20120501 UNAPPROVED DRUG OTHER WH Nutritionals, LLC CYANOCOBALAMIN; FOLIC ACID; HEME IRON POLYPEPTIDE; IRON SUCROSE 25; 1; 6; 22 ug/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 76331-901_0ac91e69-55af-47da-a726-6657cba05a1e 76331-901 HUMAN PRESCRIPTION DRUG HemeNatal OB CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL SUCCINATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, IRON SUCROSE, HEME IRON POLYPEPTIDE, POTASSIUM IODIDE, ZINC OXIDE, SODIUM SELENATE, CUPRIC SULFATE TABLET ORAL 20120308 UNAPPROVED DRUG OTHER WH Nutritionals, LLC .ALPHA.-TOCOPHEROL SUCCINATE, D-; BIOTIN; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FOLIC ACID; HEME IRON POLYPEPTIDE; IRON SUCROSE; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM SELENATE; THIAMINE MONONITRATE; ZINC OXIDE 10; 30; 10; 400; .8; 12; 1; 6; 28; 17; 250; 50; 1.6; 65; 1.5; 4.5 [iU]/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 76331-904_6f065bf4-8aca-43e8-b951-8036fe5fcb12 76331-904 HUMAN PRESCRIPTION DRUG HemeNatal OB plus DHA CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL SUCCINATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, IRON SUCROSE, HEME IRON POLYPEPTIDE, POTASSIUM IODIDE, ZINC OXIDE, SODIUM SELENATE, CUPRIC SULFATE, DOCONEXENT, LINOLENIC ACID, OSBOND ACID KIT 20120308 UNAPPROVED DRUG OTHER WH Nutritionals, LLC 76331-905_8b17d2c3-f799-4d42-85c3-bd79695487bd 76331-905 HUMAN PRESCRIPTION DRUG Nutri-Tab OB SODIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM FORMATE, CALCIUM CARBONATE, FERROUS BISGLYCINATE, POTASSIUM IODIDE, ZINC OXIDE, CHOLINE BITARTRATE TABLET ORAL 20120503 UNAPPROVED DRUG OTHER WH Nutritionals, LLC .ALPHA.-TOCOPHEROL ACETATE, D-; CALCIUM CARBONATE; CALCIUM FORMATE; CHOLECALCIFEROL; CHOLINE BITARTRATE; CYANOCOBALAMIN; FERROUS BISGLYCINATE; FOLIC ACID; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC OXIDE 30; 45; 155; 450; 55; 10; 32; 1000; 20; 100; 50; 3; 120; 3; 10 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 76331-908_63070a7f-f5d7-4a19-a68e-a5aea95e5db9 76331-908 HUMAN PRESCRIPTION DRUG Nutri-Tab OB plus DHA SODIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM FORMATE, CALCIUM CARBONATE, FERROUS BISGLYCINATE, POTASSIUM IODIDE, ZINC OXIDE, CHOLINE BITARTRATE, DOCONEXENT, ICOSAPENT KIT 20120503 UNAPPROVED DRUG OTHER WH Nutritionals, LLC 76331-909_25110de3-c0be-4b94-bb18-d989051f2f67 76331-909 HUMAN PRESCRIPTION DRUG Nata Komplete VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACIN, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, PANTOTHENIC ACID, CALCIUM, IRON, MAGNESIUM, ZINC, SELENIUM, COPPER, CHOLINE BITARTRATE TABLET ORAL 20110625 UNAPPROVED DRUG OTHER WH Nutritionals, LLC .ALPHA.-TOCOPHEROL; ASCORBIC ACID; BIOTIN; CALCIUM; CHOLECALCIFEROL; CHOLINE BITARTRATE; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; SELENIUM; THIAMINE; VITAMIN A; ZINC 20; 120; 30; 100; 400; 55; 2; 12; 1; 25; 50; 20; 8; 30; 3.5; 50; 3; 2700; 15 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; [iU]/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] 76331-910_7ace3676-d9de-44c1-8f90-bfabc3c660c6 76331-910 HUMAN PRESCRIPTION DRUG Niron Komplete ASCORBIC ACID, .ALPHA.-TOCOPHEROL, FOLIC ACID, CYANOCOBALAMIN, IRON TABLET ORAL 20110625 UNAPPROVED DRUG OTHER WH Nutritionals, LLC .ALPHA.-TOCOPHEROL; ASCORBIC ACID; CYANOCOBALAMIN; FOLIC ACID; IRON 20; 120; 12; 1; 30 [iU]/1; mg/1; ug/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 76332-001_ff4c94f1-767c-4cc5-8111-76507f40a8a7 76332-001 HUMAN OTC DRUG AVAPTA Menthol CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part348 Neel Products LLC MENTHOL 4 g/100g 76332-002_15c7eac6-5bd6-472a-9891-4420e558796e 76332-002 HUMAN OTC DRUG AVAPTA ALLANTOIN, HEXYLRESORCINOL, MENTHOL, WHITE CAMPHOR SPRAY TOPICAL 20120816 OTC MONOGRAPH NOT FINAL part347 Neel Products LLC ALLANTOIN; CAMPHOR (NATURAL); HEXYLRESORCINOL; MENTHOL 5; 9; 1; 4 mg/mL; mg/mL; mg/mL; mg/mL 76332-003_4b5e7741-a66f-46c2-a3f4-354bd96317be 76332-003 HUMAN OTC DRUG AVAPTA BENZALKONIUM CHLORIDE, HEXYLRESORCINOL, ZINC CHLORIDE SPRAY ORAL 20120816 OTC MONOGRAPH NOT FINAL part356 Neel Products LLC BENZALKONIUM CHLORIDE; HEXYLRESORCINOL; ZINC CHLORIDE .2; 1; 2 mg/mL; mg/mL; mg/mL 76332-004_8e6a1c55-6a13-4617-8b4d-649bcea71d10 76332-004 HUMAN OTC DRUG AVAPTA HEXYLRESORCINOL SPRAY ORAL 20120816 OTC MONOGRAPH NOT FINAL part356 Neel Products LLC HEXYLRESORCINOL 1 mg/mL 76334-001_d2bd802d-8b2a-45a9-bbd5-62df04fe1436 76334-001 HUMAN OTC DRUG PEN Prep MAGNESIUM CITRATE POWDER, FOR SOLUTION ORAL 20100701 OTC MONOGRAPH FINAL part331 PEN Prep LLC MAGNESIUM CITRATE 17 g/100g 76334-002_411ab635-a095-416a-b679-e0b4c4e3dcf8 76334-002 HUMAN OTC DRUG PEN Prep Plus MAGNESIUM CITRATE POWDER, FOR SOLUTION ORAL 20100701 OTC MONOGRAPH FINAL part331 PEN Prep LLC DIMETHICONE; MAGNESIUM CITRATE .08; 17 g/100g; g/100g 76335-001_c23fba7e-a958-4412-933b-6782485cab43 76335-001 HUMAN OTC DRUG Energy Enhancer Alfalfa, Ambra Grisea, Anacardium Orientale, Argenticum Nitricum, Aurum Metallicum, Avena Sativa, Caladium Seguinum, Calcarea Carbonica, Cocculus Indicus, Gelsemium, Ignatia Amara, Kali Phosphoricum, Lycopodium, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Phosphorus, Selenium, Sepia, Silicea, Sulphur PATCH TOPICAL 20091231 UNAPPROVED HOMEOPATHIC Lifewave, Inc. ALFALFA; AMBERGRIS; ANAMIRTA COCCULUS SEED; AVENA SATIVA FLOWERING TOP; DIEFFENBACHIA SEGUINE; GELSEMIUM SEMPERVIRENS ROOT; GOLD; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SILVER NITRATE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 76335-002_81b051a9-c820-4ecf-a85e-a53d6c398797 76335-002 HUMAN OTC DRUG Silent Nights Aconitum Napellus, Arsenicum Album, Avena Sativa, Belladonna, Camphora, Cinchona Officinalis, Coffea Cruda, Cypripedium Pubescens, Hyoscyamus Niger, Passiflora Incarnata, Pulsatilla, Valeriana Officinalis PATCH TOPICAL 20091231 UNAPPROVED HOMEOPATHIC Lifewave, Inc. ACONITUM NAPELLUS; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BELLADONNA LEAF; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; CYPRIPEDIUM PARVIFOLUM ROOT; HYOSCYAMUS NIGER; PASSIFLORA INCARNATA FLOWER; PULSATILLA VULGARIS; VALERIAN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 76335-003_ad893816-b204-4661-8ad3-009d6bda7d8c 76335-003 HUMAN OTC DRUG SP6 Complete Abies Canadensis, Ammonium Bromatum, Ammonium Muriaticum, Anaradium Orientale, Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Capsicum, Cinchona, Ferrum Metallicum, Fucus, Ignatia, Kali Bichromicum, Natrum Sulphuricum, Oleander, Phosphorus, Phytolacca, Sabadilla, Staphysagria, Sulphur, Thyroidinum, Veratrum Album PATCH TOPICAL 20091231 UNAPPROVED HOMEOPATHIC Lifewave, Inc. AMMONIUM BROMIDE; AMMONIUM CHLORIDE; ANTIMONY TRISULFIDE; CAPSICUM; CINCHONA OFFICINALIS BARK; DELPHINIUM STAPHISAGRIA SEED; FUCUS VESICULOSUS; IRON; NERIUM OLEANDER LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; SCHOENOCAULON OFFICINALE SEED; SEMECARPUS ANACARDIUM JUICE; SILVER; SODIUM SULFATE; STRYCHNOS IGNATII SEED; SULFUR; THYROID, UNSPECIFIED; TSUGA CANADENSIS BARK; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 76335-004_8feec555-4603-4521-9528-0520259fa8d9 76335-004 HUMAN OTC DRUG Y-Age Carnosine Abrotanum, Anacardium, Arsenicum Album, Baryta Carbonica, Baryta Muriatium, Calcarea Carbonica, Calcarea Flourica, Calcarea Phosphorica, Ferrum Metallicum, Fucus Vesiculosus, Hekla, Helleborus Niger, Ignatia Amara, Lycopodium, Nicotinamidum, Secale, Silicea PATCH TOPICAL 20091231 UNAPPROVED HOMEOPATHIC Lifewave, Inc. ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CALCIUM FLUORIDE; CALCIUM PHOSPHATE; CLAVICEPS PURPUREA SCLEROTIUM; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; IRON; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; SILVER; STRYCHNOS IGNATII SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 76335-005_72fea124-d288-4687-abae-76846f07c9cf 76335-005 HUMAN OTC DRUG Y-age AEON Aconitum Napellus, Arsenicum Album, Bryonia Alba, Baryta Carbonica, Calcarea Carbonica, Cantharis, Gelsemium Sempervirens, Graphites, Hydrastis Canadensis, Kali Iodatum, Lachesis Mutus, Lycopodium Clavatum, Mercurius Vivus, Natrum Muriaticum, Nux Vomica, Phosphorus, Phytolacca Decandra, Pulsatilla, Rhus Toxicodendron, Sepia, Silicea, Sulphur PATCH TOPICAL 20091231 UNAPPROVED HOMEOPATHIC Lifewave, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; GRAPHITE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; MERCURY; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM IODIDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 76335-006_dfea59ca-3ce8-45c1-a068-d7c85457f74d 76335-006 HUMAN OTC DRUG Icewave Actaea, Aesculus Hipp, Arnica, Bellis, Bryonia, Calc Carb, Calc Fluor, Causticum, Cimicifuga, Formicum Acidum, Hypericum, Ledum, Lithium Carb, Mag Phos, Phosphorus, Phytolacca Decandra, Pulsatilla, Rhododendron, Rhus Tox, Ruta, Salicylicum Acidum, Sepia, Zinc Metallicum PATCH TOPICAL 20091231 UNAPPROVED HOMEOPATHIC Lifewave, Inc. ACTAEA SPICATA ROOT; AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAUSTICUM; FORMIC ACID; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 76335-007_6400df76-6838-4b86-871c-ae68e43f1a89 76335-007 HUMAN OTC DRUG Y-Age Glutathione Abrotanum, Anacardium, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Fluor, Calc Phos, Ferrum Met, Fucus, Hekla, Hellbor Nig, Ignatia, Lycopodium, Nicotinamidum, Secale, Silicea PATCH TOPICAL 20091231 UNAPPROVED HOMEOPATHIC Lifewave, Inc. ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CALCIUM FLUORIDE; CALCIUM PHOSPHATE; CLAVICEPS PURPUREA SCLEROTIUM; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; IRON; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEMECARPUS ANACARDIUM JUICE; SILICON DIOXIDE; STRYCHNOS IGNATII SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 76336-455_e197feb2-9524-4620-a67f-4c3a1c792c84 76336-455 HUMAN PRESCRIPTION DRUG METOPiRONE Metyrapone CAPSULE, GELATIN COATED ORAL 20140814 NDA NDA012911 Laboratoire HRA Pharma METYRAPONE 250 mg/1 Adrenal Steroid Synthesis Inhibitor [EPC],Adrenal Steroid Synthesis Inhibitors [MoA] 76340-1001_8bf094ed-d730-445e-a5ae-8c65ac55ec9b 76340-1001 HUMAN OTC DRUG YS Solution Ac control Skin Regular Mild salicylic acid LIQUID TOPICAL 20110810 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd SALICYLIC ACID .47 mL/100mL 76340-1101_e331d4c1-599f-4c21-8a10-e5d7626425af 76340-1101 HUMAN OTC DRUG YS Solution Intensive AC Care salicylic acid GEL TOPICAL 20110810 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd SALICYLIC ACID .47 mL/100mL 76340-1201_9a44ef62-8e9c-4417-8747-6daef042424a 76340-1201 HUMAN OTC DRUG Dr. Eslee Physical Sunscreen Zinc oxide CREAM TOPICAL 20130628 OTC MONOGRAPH FINAL part347 Ajou Medics Co., Ltd ZINC OXIDE .01248 g/g 76340-1301_08fa2bfb-cfb9-4b85-bbc5-e850ddfdb5ac 76340-1301 HUMAN OTC DRUG Dr.eslee Intensive Recovery Blemish Balm Zinc oxide CREAM TOPICAL 20140723 OTC MONOGRAPH FINAL part347 Ajou Medics Co., Ltd ZINC OXIDE .01248 g/g 76340-2001_1fa11bd2-9f9e-4f2f-9046-615f8db02a0f 76340-2001 HUMAN OTC DRUG YS Solution Ac Care salicylic acid CREAM TOPICAL 20110810 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd SALICYLIC ACID .47 mL/100mL 76340-3001_0b744657-b585-4a20-927a-d5a88a11f12b 76340-3001 HUMAN OTC DRUG Dr.eslee Sun Matte OCTINOXATE LIQUID TOPICAL 20110810 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd OCTINOXATE 7.5 g/100g 76340-4001_8193343f-408d-41ac-80b1-e3ceca18c791 76340-4001 HUMAN OTC DRUG Dr.eslee Sun Protection OCTINOXATE CREAM TOPICAL 20110810 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd OCTINOXATE 7 g/100g 76340-5001_a9970e98-7bad-4f2e-b25f-0f60ca838dcb 76340-5001 HUMAN OTC DRUG Dr.eslee Skin Mild salicylic acid LIQUID TOPICAL 20110810 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd SALICYLIC ACID .48 mL/100mL 76340-6001_93559658-a3bb-4b6b-9aa6-3aee6f8690ad 76340-6001 HUMAN OTC DRUG Dr.eslee Triple Action BB ADENOSINE CREAM TOPICAL 20110913 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd ADENOSINE .2 g/100g 76340-7001_943d8c5d-db3a-4a7c-9182-f930594d0959 76340-7001 HUMAN OTC DRUG Bellaskin Brightening Contour Essence NIACINAMIDE CREAM TOPICAL 20110913 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd NIACINAMIDE 2 mL/100mL 76340-8001_aea72323-c81e-44db-847b-96e6b3948ed2 76340-8001 HUMAN OTC DRUG Bellaskin Skin-rebirth Contour ADENOSINE CREAM TOPICAL 20110913 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd ADENOSINE .04 mL/100mL 76340-9001_9bf31400-7baf-46b0-afb8-434c8289a396 76340-9001 HUMAN OTC DRUG YS Solution Ac control Skin Regular Mild salicylic acid LIQUID TOPICAL 20111025 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd SALICYLIC ACID .47 mL/100mL 76344-2001_68b04481-27e7-4ffe-a53d-5b47bce9707c 76344-2001 HUMAN OTC DRUG MediSpa Sunspray (sunblock) OCTINOXATE, AMILOXATE, BEMOTRIZINOL, TITANIUM DIOXIDE SPRAY TOPICAL 20130329 OTC MONOGRAPH NOT FINAL part352 Humex,Inc. AMILOXATE; BEMOTRIZINOL; OCTINOXATE; TITANIUM DIOXIDE 2; 2; 7.5; 1.4 g/100mL; g/100mL; g/100mL; g/100mL 76344-4001_a32c41ef-3e72-4eb3-9903-da892a731378 76344-4001 HUMAN OTC DRUG Laser Sun Block 100 SPF50 OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20130515 OTC MONOGRAPH NOT FINAL part352 Humex,Inc. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 2.49; 4.8 g/100mL; g/100mL; g/100mL; g/100mL 76344-6001_8d87fd3e-beb9-4a6c-88b6-1fe82e3e9338 76344-6001 HUMAN OTC DRUG Derma Blemish Balm Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20130422 OTC MONOGRAPH NOT FINAL part352 Humex,Inc. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 6.5; 4.24; 3.5 g/100mL; g/100mL; g/100mL 76345-8179_fc79c87a-9714-44d1-b93c-bded4e9149d7 76345-8179 HUMAN OTC DRUG Nurigene Nourishing Daytime SPF 15 Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20110815 OTC MONOGRAPH FINAL part352 Peninsula Skincare Labs Inc OCTINOXATE; OCTISALATE; OXYBENZONE 75; 45; 30 mg/mL; mg/mL; mg/mL 76346-073_01eb0b50-0bba-4dec-bebb-93304584e2e6 76346-073 HUMAN PRESCRIPTION DRUG Korlym Mifepristone TABLET ORAL 20120217 NDA NDA202107 Corcept Therapeutics Inc MIFEPRISTONE 300 mg/1 Progestational Hormone Receptor Antagonists [MoA],Progestin Antagonist [EPC] 76347-120_12069c64-ceed-44ac-a283-ee64cbe4a25a 76347-120 HUMAN OTC DRUG Foot Rehab Pain relief and moisturizer Mission Menthol, Methyl Salicylate CREAM TOPICAL 20121105 OTC MONOGRAPH NOT FINAL part348 Mission Product Holdings MENTHOL; METHYL SALICYLATE 8.5; 12.75 g/85g; g/85g 76347-125_0a3a1775-46a6-4d6c-a6e9-c0122165240f 76347-125 HUMAN OTC DRUG Anti-Chafe Stick Pro Series Allantoin STICK TOPICAL 20110726 OTC MONOGRAPH FINAL part347 Mission Product Holdings ALLANTOIN .5 g/100g 76347-126_1f873653-30e1-4cfd-9f45-37c0a86382db 76347-126 HUMAN OTC DRUG Blister Armour Anti-Friction Mission Allantoin STICK TOPICAL 20110726 OTC MONOGRAPH FINAL part347 Mission Product Holdings ALLANTOIN .5 g/100g 76348-401_6a7d5d56-5941-4ef3-8a7c-de7c276dfb91 76348-401 HUMAN OTC DRUG Molecular AF Tolnaftate OIL TOPICAL 20110701 OTC MONOGRAPH FINAL part333C Renu Laboratories, Inc. TOLNAFTATE .01 mg/mL 76349-001_61f22a5c-8307-47c4-a1fe-256aef35635f 76349-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20110701 UNAPPROVED MEDICAL GAS Southern Gas and Supply LLC OXYGEN 995 mL/L 76349-002_75eb1d60-28a6-423d-bd31-fb621d036b6f 76349-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20111101 UNAPPROVED MEDICAL GAS Southern Gas & Supply LLC NITROGEN 995 mL/L 76351-100_9fcf3934-4860-4dcb-99a4-bbcc5ae2c9ee 76351-100 HUMAN OTC DRUG Tinted Moisturizer SPF-15 Octinoxate, Octisalate and Titanium Dioxide CREAM TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part352 Femme Couture International, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.06; 2.04; 1.53 g/51.03g; g/51.03g; g/51.03g 76352-001_d28a311d-6483-4df0-aaaf-67f9e768b3bb 76352-001 HUMAN OTC DRUG Beautos Antibacterial Hand Sanitizer Lemon ALCOHOL LIQUID TOPICAL 20110802 OTC MONOGRAPH NOT FINAL part333E Artec Chemical Company Limited ALCOHOL 62 g/100g 76352-002_ba72fa57-ddab-4f03-afe9-4a1ed212daf2 76352-002 HUMAN OTC DRUG HAND SANITIZER ALCOHOL GEL TOPICAL 20140714 OTC MONOGRAPH NOT FINAL part333E Artec Chemical Company Limited ALCOHOL 65 mL/100mL 76354-001_06ecd42c-57dd-42b0-b68b-b411ec21bfdc 76354-001 HUMAN OTC DRUG ELF Clarifying Pressed SALICYLIC ACID POWDER TOPICAL 20111001 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100g 76354-002_770a04d4-b06b-4de6-ad8b-844134c32476 76354-002 HUMAN OTC DRUG eyes lips face Mineral Blemish Kit Box SULFUR POWDER TOPICAL 20101201 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SULFUR 3 g/100g 76354-003_c57f553c-0f12-4a56-880e-2791e7d8e677 76354-003 HUMAN OTC DRUG ELF Zit Zapper SALICYLIC ACID LIQUID TOPICAL 20111009 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100g 76354-004_373f9ebc-1c67-4927-8d1d-d7fbba9e12a7 76354-004 HUMAN OTC DRUG ELF Conceler Pencil and Brush SALICYLIC ACID PASTE TOPICAL 20111001 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID 2 g/100g 76354-005_7b1b209a-bb90-42bb-ad82-c540afc7a903 76354-005 HUMAN OTC DRUG ELF Super Glossy Lip Shine SPF 15 OXYBENZONE CREAM TOPICAL 20111009 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g 76354-006_18a261f3-a4c9-4c08-9d82-0403cfb9baa5 76354-006 HUMAN OTC DRUG ELF Tinted Moisturizer SPF 15 OXYBENZONE CREAM TOPICAL 20111009 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE 7.5; 3.5 g/100g; g/100g 76354-007_46fd6413-2d52-4e15-b1c7-5862a9a8875e 76354-007 HUMAN OTC DRUG ELF Mineral Foundation SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20111009 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; g/100g 76354-008_eae6dcae-f600-48e5-82a1-365265d1729b 76354-008 HUMAN OTC DRUG eyes lips face Mineral Concealer SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20111009 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; g/100g 76354-009_842b8834-ad10-43c1-b074-42e6fbef78dd 76354-009 HUMAN OTC DRUG ELF Personal Blend Foundation SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; g/100g 76354-010_ea6530da-ae23-4a46-a161-7d43d62792d6 76354-010 HUMAN OTC DRUG ELF Mineral Lip Tint SPF 8 TITANIUM DIOXIDE POWDER TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE 4 g/100g 76354-011_c4b1fc33-34d8-44b7-ad07-870c9ad4941c 76354-011 HUMAN OTC DRUG ELF Conditioning Lip Balm SPF 15 OXYBENZONE CREAM TOPICAL 20111008 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g 76354-012_7b1564ad-8c9b-4881-b1d9-d3ac83a8f4a1 76354-012 HUMAN OTC DRUG ELF Lip Balm SPF 15 OXYBENZONE CREAM TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE 7.5; 5 g/100g; g/100g 76354-013_85c9673e-8c23-4d5e-a317-5bdf16dc579c 76354-013 HUMAN OTC DRUG ELF Lip Balm SPF 15 Color OXYBENZONE CREAM TOPICAL 20111008 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE 7.5; 5 g/100g; g/100g 76354-014_b99dd686-5122-4d5b-9501-e8cad64ee7ab 76354-014 HUMAN OTC DRUG ELF Flawless Finish Foundation SPF 15 Oil Free TITANIUM DIOXIDE CREAM TOPICAL 20111003 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; TROLAMINE SALICYLATE 5.5; 2 g/100g; g/100g 76354-015_17c68a53-3e2b-46e3-b302-2c4ac1b6dfe1 76354-015 HUMAN OTC DRUG ELF Tinted Moisturizer SPF 20 OXYBENZONE CREAM TOPICAL 20111010 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 6; 3.5; 5 g/100g; g/100g; g/100g 76354-016_3cfa20d3-3d15-45d6-b446-d434c0f60674 76354-016 HUMAN OTC DRUG ELF SPF 45 Sunscreen UVA/UVB Protection TITANIUM DIOXIDE POWDER TOPICAL 20111022 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; ZINC OXIDE 23.3; 18.7 g/100g; g/100g 76354-017_0da93bfa-fe51-40fb-9e38-1983a5b7d8b1 76354-017 HUMAN OTC DRUG ELF Zit Eraser SALICYLIC ACID LIQUID TOPICAL 20120129 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100g 76354-018_6cd7b4d5-fd54-47d5-b07b-75ddd62bfe5e 76354-018 HUMAN OTC DRUG ELF Zit Zapping Conceler SALICYLIC ACID PASTE TOPICAL 20120102 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100g 76354-019_9d992249-d527-4b0a-8761-87e51d643293 76354-019 HUMAN OTC DRUG ELF ACNE Fighting Foundation SALICYLIC ACID CREAM TOPICAL 20130309 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL 76354-101_475770fe-c7e3-4cba-bfa4-adfe3e67cf7d 76354-101 HUMAN OTC DRUG ELF BB SPF-20 OXYBENZONE, OCTISALATE, AND OCTINOXATE CREAM TOPICAL 20131010 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 4 g/100g; 1/100g; g/100g 76354-102_71f6322f-35fc-47cf-adb8-41e658982c1c 76354-102 HUMAN OTC DRUG ELF TINTED MOISTURIZER SPF-20 OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE CREAM TOPICAL 20131010 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 6; 3.5; 5 g/100mL; 1/100mL; g/100mL 76354-103_5c4bf2cf-3501-40e5-85cc-4bdbf79cd625 76354-103 HUMAN OTC DRUG MINERAL FOUNDATION SPF 15 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20131010 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; 1/100g 76354-104_b2d22849-2d43-4286-a9d1-cff30680e9ff 76354-104 HUMAN OTC DRUG PERSONAL BLEND FOUNDATION SPF 15 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20131010 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; 1/100g 76354-105_23529c68-00c0-499d-86d4-c1c9e699c3c6 76354-105 HUMAN OTC DRUG ELF Super Glossy Lip Shine SPF 15 OXYBENZONE, OCTINOXATE CREAM TOPICAL 20111009 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g 76354-106_0093cbb0-585f-4188-aedb-05cde9b94b2a 76354-106 HUMAN OTC DRUG FLAWLESS FINISH FOUNDATION SPF 15 SUNSCREEN OCTISALATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131010 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC OCTISALATE; TITANIUM DIOXIDE 2; 5.5 g/100g; 1/100g 76354-107_1629814c-6550-4ec0-b4b1-5ef80843dcfa 76354-107 HUMAN OTC DRUG SPF-45 SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20140512 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; ZINC OXIDE 23.3; 18.7 g/100g; 1/100g 76354-108_7051244f-cd47-498e-a489-0e738ed21b92 76354-108 HUMAN OTC DRUG SPF-20 FACE PRIMER OCTINOXATE, OXYBENZONE, OCTISALATE CREAM TOPICAL 20140512 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OCTISALATE; OXYBENZONE 7; 5; 5 g/100g; g/100g; g/100g 76354-109_cd855251-daf3-4e9e-b9ce-695ac9d26f4a 76354-109 HUMAN OTC DRUG MINERAL CONCEALER SPF 20 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20131010 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; 1/100g 76354-110_27bf3917-40f1-45a5-83f9-d398c36439ce 76354-110 HUMAN OTC DRUG LIP BALM SPF 15 OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20140610 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE 7.5; 5 g/100g; g/100g 76354-112_2bdf899a-05d5-4c24-b7ce-03c8971179de 76354-112 HUMAN OTC DRUG ELF TINTED MOISTURIZER SPF-20 OCTINOXATE, OXYBENZONE, OCTISALATE CREAM TOPICAL 20140826 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 3 g/100mL; g/100mL; 1/100mL 76354-201_fdba8c12-9186-4605-9cbc-216a4a1f176f 76354-201 HUMAN OTC DRUG CLARIFYING PRESSED POWDER SALICYLIC ACID POWDER TOPICAL 20131010 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100g 76354-202_0cf32254-c84c-4f5a-8e3e-2eac2bf37e9f 76354-202 HUMAN OTC DRUG ZIT ZAPPER SALICYLIC ACID CREAM TOPICAL 20131010 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100g 76354-203_5442cc78-46c4-4ac0-8dc8-4938aa81d00e 76354-203 HUMAN OTC DRUG ACNE FIGHTING FOUNDATION SALICYLIC ACID CREAM TOPICAL 20140202 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL 76354-204_326e4709-c99b-4276-80a6-53f7bbe2c3ad 76354-204 HUMAN OTC DRUG CONCEALER PENCIL AND BRUSH SALICYLIC ACID CREAM TOPICAL 20140202 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SALICYLIC ACID 2 1/100g 76354-205_17074116-d927-4be7-8556-458e2417165f 76354-205 HUMAN OTC DRUG MINERAL BLEMISH KIT SULFUR POWDER TOPICAL 20131010 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SULFUR 3 1/100g 76354-206_53d31a29-b5f8-42e5-8774-ea72a764493a 76354-206 HUMAN OTC DRUG ZIT ERASER SALICYLIC ACID CREAM TOPICAL 20131010 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100g 76357-106_f89f4900-e664-4495-ad93-e867c84b0b24 76357-106 HUMAN OTC DRUG SmartMouth Advance Clinical Formula Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20110617 OTC MONOGRAPH FINAL part355 Triumph Pharmaceuticals Inc. SODIUM MONOFLUOROPHOSPHATE 17 g/170g 76357-200_61db32ff-d376-4c7b-846d-69071cfcd763 76357-200 HUMAN OTC DRUG SmartMouth Advance Clinical Formula Mint Cetylpyridinium Chloride KIT 20110617 OTC MONOGRAPH NOT FINAL part356 Triumph Pharmaceuticals Inc. 76357-212_64dd6731-01c9-410e-a733-608500be8f14 76357-212 HUMAN OTC DRUG SmartMouth Advance Clinical Formula Cinnamon Cetylpyridinium Chloride KIT 20110625 OTC MONOGRAPH NOT FINAL part356 Triumph Pharmaceuticals Inc. 76363-029_69d4e189-3862-45ee-8a86-5adcb7478a9b 76363-029 HUMAN OTC DRUG LOVEA Titanium dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH FINAL part352 Laboratoires Biocos TITANIUM DIOXIDE 12.1 g/100g 76365-0101_f719162f-cb78-487c-b172-ac10d009e6f5 76365-0101 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine hydrochloride CAPSULE ORAL 20120601 ANDA ANDA075464 Prodigy Health Supplier FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76365-0102_f719162f-cb78-487c-b172-ac10d009e6f5 76365-0102 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine hydrochloride CAPSULE ORAL 20120601 ANDA ANDA075464 Prodigy Health Supplier FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] 76366-001_17021a4d-7bf2-4f5e-b0b2-eb1de1c665f9 76366-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19930101 UNAPPROVED MEDICAL GAS Cryo Weld Corporation OXYGEN 99 L/100L 76366-002_4b7fa3b3-61c5-48b3-8bd5-f7254da352b6 76366-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20120601 UNAPPROVED MEDICAL GAS Cryo Weld Corporation NITROGEN 99 L/100L 76369-1001_b2ca2351-0c83-4085-b2d7-4f775d4dbf38 76369-1001 HUMAN OTC DRUG Clara PSYLLIUM HUSK GRANULE ORAL 20110826 UNAPPROVED DRUG OTHER Handock Cosmetics Inc PSYLLIUM HUSK 3.25 g/5g 76369-2001_0af8b8c1-6825-420f-846d-7d398e56cc02 76369-2001 HUMAN OTC DRUG MSM (MoSaengMo) POLYQUATERNIUM-10 (400 CPS AT 2%) SHAMPOO TOPICAL 20110830 UNAPPROVED DRUG OTHER Handock Cosmetics Inc POLYQUATERNIUM-10 (400 CPS AT 2%) .4 mL/200mL 76369-3001_d9895fee-6b24-46b0-b8fd-735c23e1059e 76369-3001 HUMAN OTC DRUG MSM (MoSaengMo) PROPYLENE GLYCOL LIQUID TOPICAL 20110830 UNAPPROVED DRUG OTHER Handock Cosmetics Inc PROPYLENE GLYCOL 23.85 mL/150mL 76369-4001_43b82c7a-5c61-48d7-9e50-4878a42aee6b 76369-4001 HUMAN OTC DRUG MSM (MoSaengMo) POLYQUATERNIUM-10 (400 CPS AT 2%) SHAMPOO TOPICAL 20110830 UNAPPROVED DRUG OTHER Handock Cosmetics Inc POLYQUATERNIUM-10 (400 CPS AT 2%) .4 mL/200mL 76369-5001_01778970-950f-43ff-b8b8-4e90e98f8e25 76369-5001 HUMAN OTC DRUG MSM (MoSaengMo) PROPYLENE GLYCOL LIQUID TOPICAL 20111111 UNAPPROVED DRUG OTHER Handock Cosmetics Inc PROPYLENE GLYCOL 23.85 mL/150mL 76369-6001_668ce835-5a1c-4454-9360-e7b74a4576b5 76369-6001 HUMAN OTC DRUG MSM (MoSaengMo) PROPYLENE GLYCOL LIQUID TOPICAL 20111111 UNAPPROVED DRUG OTHER Handock Cosmetics Inc PROPYLENE GLYCOL 23.85 mL/150mL 76369-7001_c0cedb80-4476-4814-b542-61b38ff47de2 76369-7001 HUMAN OTC DRUG Clara PSYLLIUM HUSK GRANULE ORAL 20111111 UNAPPROVED DRUG OTHER Handock Cosmetics Inc PSYLLIUM HUSK 3.25 g/5g 76370-0001_213a6eaf-171d-4dd0-9851-833ef5e186cf 76370-0001 HUMAN OTC DRUG Tazza Benzalkonium Chloride CLOTH TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part333E Terraboost Media LLC BENZALKONIUM CHLORIDE .0062 g/1 76378-011_0d71b8ab-a8f1-45e3-bf3d-ebf6c87d81e8 76378-011 HUMAN OTC DRUG Servo Stat-Foam Alcohol LIQUID TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333A Enzyme Solutions, Inc. ALCOHOL 62 mL/100mL 76378-012_9140f7cc-cb62-4857-a084-c119435e9c35 76378-012 HUMAN OTC DRUG Servo-Stat T Triclosan LIQUID TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333A Enzyme Solutions, Inc. TRICLOSAN .3 mL/100mL 76378-013_ecd181cb-587e-4f45-810a-968c9f09d668 76378-013 HUMAN OTC DRUG Servo-Stat TE Triclosan LIQUID TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333A Enzyme Solutions, Inc. TRICLOSAN .3 mL/100mL 76378-014_7f5dcc02-f810-4a35-abbd-e6b3a46dc6a5 76378-014 HUMAN OTC DRUG Servo-Stat T Foam Triclosan LIQUID TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333A Enzyme Solutions, Inc. TRICLOSAN .3 mL/100mL 76378-015_e763efd9-071d-4094-9138-da787c53888a 76378-015 HUMAN OTC DRUG Servo-Stat Alcohol GEL TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333A Enzyme Solutions, Inc. ALCOHOL 62 mL/100mL 76378-016_5be6c348-c031-498a-a6b5-bee5e709731f 76378-016 HUMAN OTC DRUG Servo-Stat Balm Alcohol GEL TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333A Enzyme Solutions, Inc. ALCOHOL 62 mL/100mL 76378-017_0f59fb74-ab4b-41b5-b8cc-1937c5e06214 76378-017 HUMAN OTC DRUG Servo-Stat P Chloroxylenol LIQUID TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333A Enzyme Solutions, Inc. CHLOROXYLENOL .6 mL/100mL 76378-020_135e864b-449f-4e9c-aaa8-16c1e9075fef 76378-020 HUMAN OTC DRUG Servo Stat BAC BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131114 OTC MONOGRAPH NOT FINAL part333A Enzyme Solutions, Inc. BENZALKONIUM CHLORIDE 1 mg/mL 76379-100_48ca69c4-d391-4ee9-ad2d-ba266b55c574 76379-100 HUMAN OTC DRUG Game Day MSC Mainstreet Collection Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110803 OTC MONOGRAPH FINAL part333E Mainstreet Collection ALCOHOL 75 mL/100mL 76384-001_cac36aa0-45ea-45f5-983f-72f933c36c79 76384-001 HUMAN OTC DRUG Quality Petroleum Jelly White petroleum JELLY TOPICAL 20110815 OTC MONOGRAPH FINAL part347 Worldwide Sales & Distribution Corp. PETROLATUM 1 g/g 76384-002_cac36aa0-45ea-45f5-983f-72f933c36c79 76384-002 HUMAN OTC DRUG Quality Petroleum Jelly Baby Fresh Scent White petroleum JELLY TOPICAL 20110815 OTC MONOGRAPH FINAL part347 Worldwide Sales & Distribution Corp. PETROLATUM 1 g/g 76384-003_cac36aa0-45ea-45f5-983f-72f933c36c79 76384-003 HUMAN OTC DRUG Quality Petroleum Cocoa Butter Scent White petroleum JELLY TOPICAL 20101101 OTC MONOGRAPH FINAL part347 Worldwide Sales & Distribution Corp. PETROLATUM 1 g/g 76384-004_cac36aa0-45ea-45f5-983f-72f933c36c79 76384-004 HUMAN OTC DRUG Quality Petroleum Aloe Vera White petroleum JELLY TOPICAL 20110815 OTC MONOGRAPH FINAL part347 Worldwide Sales & Distribution Corp. PETROLATUM 1 g/g 76384-005_b20373e6-e571-4556-94d9-42dd43d15865 76384-005 HUMAN OTC DRUG ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL LIQUID TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333A Worldwide Sales & Distribution Corp. ISOPROPYL ALCOHOL 50 mL/100mL 76384-006_b25a1d39-4bc1-4d80-b756-10a7ec4d9f8d 76384-006 HUMAN OTC DRUG ISOPROPYL WINTER GREEN RUBBING ALCOHOL ISOPROPYL ALCOHOL LIQUID TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333A Worldwide Sales & Distribution Corp. ISOPROPYL ALCOHOL 50 mL/100mL 76384-007_e853c662-f640-481a-866c-35e1aebe957d 76384-007 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20110825 OTC MONOGRAPH NOT FINAL part333A Worldwide Sales & Distribution Corp. HYDROGEN PEROXIDE .3 kg/100L 76385-100_c265374e-9962-4004-a74b-6605330055c7 76385-100 HUMAN PRESCRIPTION DRUG METHSCOPOLAMINE BROMIDE methscopolamine bromide TABLET ORAL 20131001 ANDA ANDA200602 BAYSHORE PHARMACEUTICALS LLC METHSCOPOLAMINE BROMIDE 2.5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 76385-101_c265374e-9962-4004-a74b-6605330055c7 76385-101 HUMAN PRESCRIPTION DRUG METHSCOPOLAMINE BROMIDE methscopolamine bromide TABLET ORAL 20131001 ANDA ANDA200602 BAYSHORE PHARMACEUTICALS LLC METHSCOPOLAMINE BROMIDE 5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] 76385-102_3d0927b4-586c-44de-979b-2874ec0e2ee4 76385-102 HUMAN PRESCRIPTION DRUG Primaquine Phosphate Primaquine Phosphate TABLET ORAL 20140801 ANDA ANDA204476 Bayshore Pharmaceuticals, LLC PRIMAQUINE PHOSPHATE 15 mg/1 Antimalarial [EPC] 76385-103_cdf18706-fdca-4551-8373-f3da9619dac5 76385-103 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20140131 ANDA ANDA090168 Bayshore Pharmaceuticals, LLC BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 76385-104_cdf18706-fdca-4551-8373-f3da9619dac5 76385-104 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20140131 ANDA ANDA090168 Bayshore Pharmaceuticals, LLC BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 76385-105_cdf18706-fdca-4551-8373-f3da9619dac5 76385-105 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20140131 ANDA ANDA090168 Bayshore Pharmaceuticals, LLC BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 76388-635_37120d60-9477-4629-a746-e70bee7ddf97 76388-635 HUMAN PRESCRIPTION DRUG LEUKERAN chlorambucil TABLET, FILM COATED ORAL 19850213 NDA NDA010669 Aspen Global Inc. CHLORAMBUCIL 2 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 76388-713_5fcf4541-4b08-407d-b67f-6ac95f759f90 76388-713 HUMAN PRESCRIPTION DRUG MYLERAN busulfan TABLET, FILM COATED ORAL 19850321 NDA NDA009386 Aspen Global Inc. BUSULFAN 2 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] 76388-880_f20f28e5-1a12-499b-adbc-8c949d7e1aa1 76388-880 HUMAN PRESCRIPTION DRUG TABLOID thioguanine TABLET ORAL 20130312 NDA NDA012429 Aspen Global Inc. THIOGUANINE 40 mg/1 Antimetabolite [EPC] 76391-234_f82f89c8-df9d-4b1b-b873-372c68740c2f 76391-234 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Bluegrass Oxygen, Inc. OXYGEN 99 L/100L 76394-3811_63e3538c-ee5a-40a0-9eb2-8d6290dd3d7c 76394-3811 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F 18 INJECTION INTRAVENOUS 20130627 ANDA ANDA203811 University of California, Los Angeles FLUDEOXYGLUCOSE F-18 40 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 76394-3812_bf4da480-c72f-4943-aab0-8a3f969cb501 76394-3812 HUMAN PRESCRIPTION DRUG Ammonia N 13 AMMONIA N-13 INJECTION INTRAVENOUS 20130627 ANDA ANDA203812 University of California, Los Angeles AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 76398-001_c08ab60d-9dea-4c24-9951-3baf4a1da91b 76398-001 HUMAN OTC DRUG ILLUMINATING PROTECTIVE PRIMER SPF 12 OCTINOXATE, HOMOSALATE CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 TOM FORD BEAUTY DIST HOMOSALATE; OCTINOXATE 5; 7.5 mL/100mL; mL/100mL 76398-003_d960df1a-d844-4461-be4d-6a39691a173e 76398-003 HUMAN OTC DRUG TRACELESS PERFECTING FOUNDATION BROAD SPECTRUM SPF 15 octinoxate and titanium dioxide LIQUID TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 TOM FORD BEAUTY DIST OCTINOXATE; TITANIUM DIOXIDE .03132; .01728 g/100mL; g/100mL 76401-1001_39669a6b-9ab6-4a99-8e78-95db3a7ccefd 76401-1001 HUMAN OTC DRUG Korea Gongjin-Dan PANAX GINSENG FRUIT PELLET ORAL 20120622 UNAPPROVED DRUG OTHER Songjeongo OM Clinic PANAX GINSENG FRUIT 229 mg/4g 76402-410_4acdbf3e-fa79-468f-9e18-fcf9b1f35707 76402-410 HUMAN OTC DRUG Hillyard Foaming Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20120207 OTC MONOGRAPH NOT FINAL part333E Hillyard GMP ALCOHOL 62 mL/100mL 76405-010_865235f8-9151-47c5-96f8-b531c8abeff7 76405-010 HUMAN OTC DRUG Spa Originals Instant Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110822 OTC MONOGRAPH NOT FINAL part333E Custom Solutions, Inc. ALCOHOL 62 mL/100mL 76405-011_9078ddd7-2401-4e8d-8dac-98d1e2b4f279 76405-011 HUMAN OTC DRUG Spa Originals Antibacterial Gold Hand TRICLOSAN SOAP TOPICAL 20110822 OTC MONOGRAPH NOT FINAL part333E Custom Solutions, Inc TRICLOSAN .12 mL/100mL 76414-010_f78ed317-18b3-4ddb-9087-51e2da410fdf 76414-010 HUMAN OTC DRUG E ENZYME SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110301 OTC MONOGRAPH FINAL part355 SAMJOKO SKYBLUE CO., LTD. SODIUM MONOFLUOROPHOSPHATE 1.2 g/200g 76417-8200_ba834958-0a80-4778-9383-e3dfc259a2eb 76417-8200 HUMAN OTC DRUG Analgesic menthol SPRAY TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part348 Ouwee Jones, LLC MENTHOL 700 mL/L 76419-111_5f12a74d-5877-4392-af9f-9012d9a614d8 76419-111 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F 18 INJECTION INTRAVENOUS 20140824 ANDA ANDA203937 Hot Shots NM, LLC dba Midwest Positron Technology, LC FLUDEOXYGLUCOSE F-18 500 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 76419-211_bb070745-362d-4478-a78a-2be214ddc2a7 76419-211 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F-18 INJECTION INTRAVENOUS 20140821 ANDA ANDA204530 Hot Shots NM, LLC dba Midwest Positron Technology, LC SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] 76420-372_279237de-eecc-44e1-9b97-8eeef6a3363a 76420-372 HUMAN OTC DRUG Aphen Acetaminophen TABLET ORAL 20110801 OTC MONOGRAPH NOT FINAL part343 MedChem Manufacturing, Inc ACETAMINOPHEN 325 mg/1 76420-449_b3ba0c50-ef10-4d3c-a092-1561d0c19147 76420-449 HUMAN OTC DRUG XOLIDO Lidocaine HCl CREAM TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Enovachem Manufacturing LIDOCAINE HYDROCHLORIDE 2 g/mL 76420-450_de864daf-cc3c-4cfd-985a-598edb682c62 76420-450 HUMAN OTC DRUG Calypxo Pain Relief Methyl Salicylate, Menthol CREAM TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part348 Enovachem Manufacturing MENTHOL; METHYL SALICYLATE 3; 10 g/100g; g/100g 76420-451_559b2ced-a926-4bb8-a1dc-8f8f7c41a06b 76420-451 HUMAN OTC DRUG XOLIDO Lidocaine HCl CREAM TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Enovachem Manufacturing LIDOCAINE HYDROCHLORIDE 4 g/mL 76420-470_4738bd27-48ce-4978-b740-ae911c0e408c 76420-470 VACCINE Physicians EZ Use Flu Kit influenza a virus a/christchurch/16/2010 nib-74 (h1n1) antigen (propiolactone inactivated), influenza a virus a/victoria/361/2011 ivr-165 (h3n2) antigen (propiolactone inactivated), influenza b virus b/hubei-wujiagang/158/2009 bx-39 antigen (propiolactone inactivated) and Isopropyl Alcohol KIT INTRAMUSCULAR; TOPICAL 20130401 BLA BLA103837 MedChem Manufacturing Inc. dba Enovachem 76420-471_dfff8237-021f-4504-aa21-7def22d6b09e 76420-471 VACCINE Medical Provider Single Use EZ Flu Shot Kit influenza a virus a/christchurch/16/2010 nib-74 (h1n1) antigen (propiolactone inactivated), influenza a virus a/victoria/361/2011 ivr-165 (h3n2) antigen (propiolactone inactivated), influenza b virus b/hubei-wujiagang/158/2009 bx-39 antigen (propiolactone inactivated) and Isopropyl Alcohol KIT INTRAMUSCULAR; TOPICAL 20130530 BLA BLA103837 MedChem Manufacturing Inc. dba Enovachem 76420-481_459a05f8-6b3b-453d-a8ec-c69dd22c91f5 76420-481 VACCINE Medical Provider Single Use EZ Flu Shot 2013-2014 influenza a virus a/christchurch/16/2010 nib-74 (h1n1) antigen (propiolactone inactivated), influenza a virus a/victoria/361/2011 ivr-165 (h3n2) antigen (propiolactone inactivated), influenza b virus b/hubei-wujiagang/158/2009 bx-39 antigen (propiolactone inactivated) and Isopropyl Alcohol KIT INTRAMUSCULAR; TOPICAL 20130915 BLA BLA103837 MedChem Manufacturing Inc. dba Enovachem 76420-482_857235e7-a1d4-41fb-b9b6-9d7291ed579f 76420-482 VACCINE Medical Provider Single Use EZ Flu Shot 2013-2014 influenza a virus a/christchurch/16/2010 nib-74 (h1n1) antigen (propiolactone inactivated), influenza a virus a/victoria/361/2011 ivr-165 (h3n2) antigen (propiolactone inactivated), influenza b virus b/hubei-wujiagang/158/2009 bx-39 antigen (propiolactone inactivated) and Isopropyl Alcohol KIT INTRAMUSCULAR; TOPICAL 20130530 BLA BLA103914 MedChem Manufacturing Inc. dba Enovachem 76420-483_857235e7-a1d4-41fb-b9b6-9d7291ed579f 76420-483 VACCINE Medical Provider Single Use EZ Flu Shot 2013-2014 influenza a virus a/christchurch/16/2010 nib-74 (h1n1) antigen (propiolactone inactivated), influenza a virus a/victoria/361/2011 ivr-165 (h3n2) antigen (propiolactone inactivated), influenza b virus b/hubei-wujiagang/158/2009 bx-39 antigen (propiolactone inactivated) and Isopropyl Alcohol KIT INTRAMUSCULAR; TOPICAL 20130530 BLA BLA103914 MedChem Manufacturing Inc. dba Enovachem 76420-491_891e1993-503a-4700-9f78-799b96caf154 76420-491 VACCINE Medical Provider Single Use EZ Flu Shot Fluvirin 2014-2015 influenza a virus a/christchurch/16/2010 nib-74 (h1n1) antigen (propiolactone inactivated), influenza a virus a/victoria/361/2011 ivr-165 (h3n2) antigen (propiolactone inactivated), influenza b virus b/hubei-wujiagang/158/2009 bx-39 antigen (propiolactone inactivated) and Isopropyl Alcohol KIT INTRAMUSCULAR; TOPICAL 20130915 BLA BLA103837 Asclemed USA, Inc. 76420-493_3bfb0420-80c7-4eb2-8bb2-69556e0de417 76420-493 VACCINE Medical Provider Single Use EZ Flu Shot Flucelvax 2014-2015 Kit influenza a virus a/brisbane/10/2010 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/texas/50/2012 x-223a (h3n2) antigen (mdck cell derived, propiolactone inactivated), and influenza b virus b/massachusetts/2/2012 antigen (mdck cell derived, propiolactone inactivated) and Isopropyl Alcohol KIT INTRAMUSCULAR; TOPICAL 20130701 20150630 BLA BLA125408 Asclemed USA, Inc. 76420-520_698833df-1caa-4e18-bce7-e96882f36a4f 76420-520 HUMAN PRESCRIPTION DRUG Physicians EZ Use M-pred METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE KIT EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE; TOPICAL 20130530 NDA NDA016964 MedChem Manufacturing Inc. dba Enovachem 76420-524_ee2ce525-4aa4-4bf6-9791-28beafdfa8ca 76420-524 HUMAN PRESCRIPTION DRUG Physician EZ Use Joint Tunnel and Trigger Kit AMMONIA, LIDOCAINE HYDROCHLORIDE, TRIAMCINOLONE ACETONIDE, POVIDONE-IODINE KIT INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; RESPIRATORY (INHALATION); TOPICAL 20130530 NDA NDA014901 MedChem Manufacturing Inc. dba Enovachem 76420-527_f68bac38-2d3c-4dc9-8778-ca7c606fe50f 76420-527 HUMAN PRESCRIPTION DRUG Physicians EZ Use B-12 Compliance Physicians EZ Use B-12 Compliance KIT INTRAMUSCULAR; SUBCUTANEOUS; TOPICAL 20001018 ANDA ANDA080557 MedChem Manufacturing Inc. dba Enovachem Manufacturing 76420-611_a415309b-bf4c-4c90-8220-9b91c33848a5 76420-611 HUMAN PRESCRIPTION DRUG Joint Maintenance Compliance Kit IBUPROFEN, METHYL SALICYLATE, MENTHOL, CAPSAICIN KIT ORAL; TOPICAL 20091123 ANDA ANDA078558 Enovachem Manufacturing 76420-620_505726b7-3536-4976-8b0c-732d8059cf9c 76420-620 HUMAN PRESCRIPTION DRUG Advanced DNA Medicated Collection LIDOCAINE HYDROCHLORIDE, GLYCERIN KIT ORAL; TOPICAL 19950710 ANDA ANDA040014 MedChem Manufacturing Inc. dba Enovachem 76420-635_4bde2874-4253-4687-97f1-a7f207dfbd6c 76420-635 HUMAN PRESCRIPTION DRUG Advanced DNA Medicated Collection Kit II LIDOCAINE HYDROCHLORIDE, GLYCERIN KIT ORAL; TOPICAL 20140204 ANDA ANDA040014 Asclemed USA, Inc. 76420-720_528221e7-1df3-4b08-b722-96550e850cff 76420-720 HUMAN PRESCRIPTION DRUG Bupivilog Kit marcaine, kenalog, povidone iodine KIT EPIDURAL; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL 20140204 NDA NDA016964 Asclemed USA, Inc. 76420-730_c0b35fb5-37d7-4938-ae8c-c6ee2040b5e0 76420-730 HUMAN PRESCRIPTION DRUG Marlido Kit marcaine, lidocaine, povidone iodine KIT EPIDURAL; INFILTRATION; TOPICAL 20140204 NDA NDA016964 Asclemed USA, Inc. 76420-735_679c11d0-21e9-47ad-80fd-4574ee412627 76420-735 HUMAN PRESCRIPTION DRUG Marlido 25 Kit Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine KIT EPIDURAL; INFILTRATION; TOPICAL; TOPICAL 20090908 NDA NDA016964 Asclemed USA, Inc. 76420-740_c4807eeb-5438-473b-85c4-af2b74562900 76420-740 HUMAN PRESCRIPTION DRUG MLK F1 Kit marcaine, lidocaine, kenalog, povidone iodine KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR 20140116 NDA NDA014901 Asclemed USA, Inc. 76420-742_cec890d9-5927-4e91-9dfa-9b6c11a37295 76420-742 HUMAN PRESCRIPTION DRUG MLK Kit F2 marcaine, lidocaine, kenalog, povidone iodine KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL 20140204 NDA NDA016964 Asclemed USA, Inc. 76420-743_254029f8-3fb6-4669-be8b-d1c01c4e97b4 76420-743 HUMAN PRESCRIPTION DRUG MLK F3 Kit marcaine, lidocaine, kenalog, povidone iodine KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL 20140204 NDA NDA016964 Asclemed USA, Inc. 76420-744_d6788e34-d8c9-46ae-8294-f6aeeebb3809 76420-744 HUMAN PRESCRIPTION DRUG MLK F4 Kit Triamcinolone Acetonide, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine KIT EPIDURAL; INFILTRATION; INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL 20090601 NDA NDA014901 Asclemed USA, Inc. 76420-750_9b5da9eb-b6f6-41bd-a6fe-392cc229d16a 76420-750 HUMAN PRESCRIPTION DRUG Dyural 40 Kit Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Sodium Chloride, Isopropyl Alcohol KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE; SUBCUTANEOUS; TOPICAL 20140725 NDA NDA011757 Asclemed USA, Inc. 76420-755_28789e3f-6f36-4d6f-adb4-d86262cfbbe4 76420-755 HUMAN PRESCRIPTION DRUG Dyural 80 Kit Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Sodium Chloride, Isopropyl Alcohol KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE; SUBCUTANEOUS; TOPICAL 19590528 NDA NDA011757 Asclemed USA, Inc. 76420-760_3f109a04-5dce-4288-9889-d6d83d4e7e95 76420-760 HUMAN PRESCRIPTION DRUG Lidolog Kit lidocaine, kenalog, povidone iodine KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL 20140204 NDA NDA016964 Asclemed USA, Inc. 76420-765_fe903c24-cf80-4333-a2d4-a33eb2742df9 76420-765 HUMAN PRESCRIPTION DRUG Betalido Kit Betamethasone Sodium Phosphate, Betamethasone Acetate, Lidocaine, Povidine Iodine KIT INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; PERINEURAL; TOPICAL 20140613 ANDA ANDA090747 Asclemed USA, Inc. 76420-766_b9197908-b841-49c3-a6f1-2775209c97a3 76420-766 HUMAN PRESCRIPTION DRUG DoubleDex Kit Dexamethasone Sodium Phosphate, Povidine Iodine KIT INTRAMUSCULAR; INTRAVENOUS; TOPICAL 20140725 ANDA ANDA040491 Asclemed USA, Inc. 76420-767_307e409f-0dfd-4978-901f-a127bea7d5a8 76420-767 HUMAN PRESCRIPTION DRUG Dexlido Kit Dexamethasone Sodium Phosphate, Lidocaine Hydrochloride, Povidine Iodine KIT INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL 20140725 ANDA ANDA040491 Asclemed USA, Inc. 76420-769_3811f322-3852-4fdc-988a-53e7f7c0c7b4 76420-769 HUMAN PRESCRIPTION DRUG Dexlido-M Kit Dexamethasone Sodium Phosphate, Lidocaine Hydrochloride, Maricaine, Povidine Iodine KIT EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL 20140725 ANDA ANDA040491 Asclemed USA, Inc. 76420-770_83633b57-d4a7-454a-84d7-999824fb8a99 76420-770 HUMAN PRESCRIPTION DRUG Interarticular Joint Kit AMMONIA, LIDOCAINE HYDROCHLORIDE ANHYDROUS, TRIAMCINOLONE ACETONIDE, POVIDONE-IODINE KIT INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; RESPIRATORY (INHALATION); TOPICAL 20140205 NDA NDA014901 Asclemed USA, Inc. 76420-771_1ac9d3b2-a246-4117-93dc-e7ccc6a7ac0e 76420-771 HUMAN PRESCRIPTION DRUG Ketorocaine L Kit Ketorolac Tromethamine, Lidocaine Hydrochloride, Povidine Iodine KIT INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL 19970605 ANDA ANDA074802 Asclemed USA, Inc. 76420-772_f4a07aaa-a7f6-49e1-b100-40725ffbd365 76420-772 HUMAN PRESCRIPTION DRUG Ketorocaine LM Kit Ketorolac Tromethamine, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine KIT EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL 19970605 ANDA ANDA074802 Asclemed USA, Inc. 76420-775_31989839-a391-4f5b-8430-cae0c50d176c 76420-775 HUMAN PRESCRIPTION DRUG Dyural L Kit Methylprednisolone Acetate, Lidocaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol KIT INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE; TOPICAL 19590528 NDA NDA011757 Asclemed USA, Inc. 76420-780_53f3c96c-6360-4082-85f4-204066545562 76420-780 HUMAN PRESCRIPTION DRUG Multi-Specialty Kit Depo-Medrol, Lidocaine, Isopropyl Alcohol KIT INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE; TOPICAL 20140206 NDA NDA011757 Asclemed USA, Inc. 76420-782_2466e8b9-7011-4028-9ba3-8cc972290aa2 76420-782 HUMAN PRESCRIPTION DRUG Marbeta L Kit Betamethasone Sodium Phosphate, Betamethasone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; TOPICAL 20100428 ANDA ANDA090747 Asclemed USA, Inc. 76420-785_83119181-366d-4619-ba60-1b8a7b1e3a2e 76420-785 HUMAN PRESCRIPTION DRUG Marbeta 25 Kit Betamethasone Sodium Phosphate and Betamethasone Acetate, Bupivacaine Hydrochloride, Povidine Iodine KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; TOPICAL 20100428 ANDA ANDA090747 Asclemed USA, Inc. 76420-795_d376a354-fe32-4ae7-90ee-6444baf7a623 76420-795 HUMAN PRESCRIPTION DRUG Dyural LM Kit Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE; TOPICAL 19590528 NDA NDA011757 Asclemed USA, Inc. 76420-810_4da9e3c6-2788-4986-a7bc-75144247487e 76420-810 HUMAN PRESCRIPTION DRUG Mardex 25 Kit Dexamethasone Sodium Phosphate, Bupivacaine Hydrochloride, Povidine Iodine KIT EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL 20030529 ANDA ANDA040491 Asclemed USA, Inc. 76420-944_5d731ec6-8ccc-47de-b54c-e128eee72c96 76420-944 HUMAN OTC DRUG EXOTEN-C Methyl salicylate, Menthol, Capsaicin LOTION TOPICAL 20120508 OTC MONOGRAPH NOT FINAL part348 MedChem Manufacturing Inc. CAPSAICIN; MENTHOL; METHYL SALICYLATE .002; 10; 20 g/100g; g/100g; g/100g 76426-010_73e23486-6e4a-42cb-ac08-5ce03358dfc2 76426-010 HUMAN OTC DRUG GFS BIOPROTECT HAND SANITIZER ALOE VERA BENZALKONIUM CHLORIDE AEROSOL, FOAM TOPICAL 20110920 OTC MONOGRAPH NOT FINAL part333A GFS US LLC BENZALKONIUM CHLORIDE .0013 g/g 76426-011_2c12dd4f-dbdc-49ee-bac6-5ddd0fff5d70 76426-011 HUMAN OTC DRUG GFS BIOPROTECT HAND SANITIZER ALOE VERA - BENZALKONIUM CHLORIDE SPRAY TOPICAL 20110920 OTC MONOGRAPH NOT FINAL part333A GFS US LLC BENZALKONIUM CHLORIDE .0013 g/g 76426-012_a99bdb46-8246-4ff6-a5e1-5b25f896b06b 76426-012 HUMAN OTC DRUG GFS BioProtect Hand Sanitizer Aloe Vera Benzalkonium Chloride GEL TOPICAL 20110926 OTC MONOGRAPH NOT FINAL part333A GFS US LLC BENZALKONIUM CHLORIDE .0013 g/g 76431-105_be9e6e65-21c7-11e4-8c21-0800200c9a66 76431-105 HUMAN PRESCRIPTION DRUG Juxtapid lomitapide mesylate CAPSULE ORAL 20130103 NDA NDA203858 Aegerion Pharmaceuticals, Inc. LOMITAPIDE MESYLATE 5 mg/1 Microsomal Triglyceride Transfer Protein Inhibitor [EPC],Microsomal Triglyceride Transfer Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 76431-110_be9e6e65-21c7-11e4-8c21-0800200c9a66 76431-110 HUMAN PRESCRIPTION DRUG Juxtapid lomitapide mesylate CAPSULE ORAL 20130103 NDA NDA203858 Aegerion Pharmaceuticals, Inc. LOMITAPIDE MESYLATE 10 mg/1 Microsomal Triglyceride Transfer Protein Inhibitor [EPC],Microsomal Triglyceride Transfer Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 76431-120_be9e6e65-21c7-11e4-8c21-0800200c9a66 76431-120 HUMAN PRESCRIPTION DRUG Juxtapid lomitapide mesylate CAPSULE ORAL 20130103 NDA NDA203858 Aegerion Pharmaceuticals, Inc. LOMITAPIDE MESYLATE 20 mg/1 Microsomal Triglyceride Transfer Protein Inhibitor [EPC],Microsomal Triglyceride Transfer Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] 76433-002_39e3807c-deb1-4274-9950-ad65b8776ce3 76433-002 HUMAN OTC DRUG Tapout Muscle Recovery Rapid Pain Relief Camphor SPRAY TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part348 Revive Bioscience, Inc. CAMPHOR (SYNTHETIC) 1 mL/30mL 76433-003_66e67e18-4ec4-4c88-91a1-11c9e91d737d 76433-003 HUMAN OTC DRUG TapouT Muscle Recovery Camphor CLOTH TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part348 Revive Bioscience, Inc. CAMPHOR (SYNTHETIC) 1 mL/1 76433-004_9e334bf4-0401-432d-8403-b73f21e679cb 76433-004 HUMAN OTC DRUG O24 Essential Oil Pain Relieving Camphor SPRAY TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part348 Revive Bioscience, Inc. CAMPHOR (SYNTHETIC) 1 mL/30mL 76433-005_0e7ddd10-34a5-4e0b-ae7f-528346e5eb7a 76433-005 HUMAN OTC DRUG O24 Essential Oil Pain Relieving Camphor CLOTH TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part348 Revive Bioscience, Inc. CAMPHOR (SYNTHETIC) 1 mL/1 76436-101_38a7deac-cacc-404e-939c-b28cc2bf9d87 76436-101 HUMAN OTC DRUG DERMOPLUS MEDICATED TRICLOSAN SOAP TOPICAL 20140322 OTC MONOGRAPH NOT FINAL part333E Viny Health and Beauty Inc TRICLOSAN .3 g/100g 76436-127_da6ed796-7525-4212-959f-a56c5c055f86 76436-127 HUMAN OTC DRUG Sof Skin Vaporizing Chest Rub and Cough Suppressant Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20100310 OTC MONOGRAPH FINAL part341 Viny Health and Beauty Inc CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 5.31; 1.13; 2.26 g/113g; g/113g; g/113g 76436-128_2b05c596-b156-4223-a0c2-c4f7c23243eb 76436-128 HUMAN OTC DRUG Sof Skin Pure Petroleum Petrolatum JELLY TOPICAL 20070327 OTC MONOGRAPH FINAL part347 Viny Health and Beauty Inc PETROLATUM 100 g/100g 76436-129_2ef4e0df-84e8-4782-90c2-15a3e678741e 76436-129 HUMAN OTC DRUG Sof Skin Baby Petroleum Petrolatum JELLY TOPICAL 20070327 OTC MONOGRAPH FINAL part347 Viny Health and Beauty Inc PETROLATUM 99.9 g/100g 76436-130_d5421ee8-3b33-45d0-afa6-0a462221bebd 76436-130 HUMAN OTC DRUG Sof Skin Pure Petroleum Cocoa Butter Scented Petrolatum JELLY TOPICAL 20070327 OTC MONOGRAPH FINAL part347 Viny Health and Beauty Inc PETROLATUM 99.9 g/100g 76436-131_f719019c-1629-4d2a-a494-c909c77cfe0a 76436-131 HUMAN OTC DRUG Sof Skin Baby Oil Mineral Oil OIL TOPICAL 20070327 OTC MONOGRAPH FINAL part347 Vini Health & Beauty Inc MINERAL OIL 1 mL/mL 76436-133_88a65e01-987a-43ab-83bc-736fcbfc1fcf 76436-133 HUMAN OTC DRUG Sof Skin Icy Blue Menthol GEL TOPICAL 20070327 OTC MONOGRAPH FINAL part341 Viny Health and Beauty Inc MENTHOL 1 g/100g 76436-135_26a05bab-eb65-43a9-9e6b-5d0aa164263b 76436-135 HUMAN OTC DRUG Sof Skin Baby Powder Talc POWDER TOPICAL 20070327 OTC MONOGRAPH NOT FINAL part347 Viny Health and Beauty Inc TALC 1 g/g 76436-137_63e03d9c-12bc-4fe7-8e85-74b17d51df81 76436-137 HUMAN OTC DRUG Dusting Powder Talc POWDER TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part347 Viny Health and Beauty Inc TALC 99 g/100g 76436-201_1f908f82-097d-4be6-b193-955eaa5548e7 76436-201 HUMAN OTC DRUG SOFT AND PRECIOUS NURSERY WITH ALOE AND VITAMIN E Petrolatum JELLY TOPICAL 20140719 OTC MONOGRAPH FINAL part347 Viny Health and Beauty Inc PETROLATUM 99.9 g/100g 76436-202_8e0cc131-0725-4fcd-9ecd-7ac2f963533a 76436-202 HUMAN OTC DRUG SOFT AND PRECIOUS NURSERY BABY POWDER SCENT Petrolatum JELLY TOPICAL 20140719 OTC MONOGRAPH FINAL part347 Viny Health and Beauty Inc PETROLATUM 99.9 g/100g 76436-203_c2a28ec7-1f81-4899-aab4-4ee591c9ffec 76436-203 HUMAN OTC DRUG SOFT AND PRECIOUS NURSERY WITH LAVENDER AND CHAMOMILE Petrolatum JELLY TOPICAL 20140719 OTC MONOGRAPH FINAL part347 Viny Health and Beauty Inc PETROLATUM 99.8 g/100g 76436-204_0ba71fd3-e783-4a77-9b3f-cdcc1642e97c 76436-204 HUMAN OTC DRUG SOFT AND PRECIOUS NURSERY INFUSED WITH SHEA BUTTER Petrolatum JELLY TOPICAL 20140719 OTC MONOGRAPH FINAL part347 Viny Health and Beauty Inc PETROLATUM 99.6 g/100g 76436-301_5bd47867-2493-4f07-bc24-88eca27e8c61 76436-301 HUMAN OTC DRUG RUBBING ALCOHOL 50 PERCENT ISOPROPYL ALCOHOL LIQUID TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333A Viny Health and Beauty Products Inc ISOPROPYL ALCOHOL 50 mL/100mL 76436-302_44a2dff5-fe86-42be-8eea-3c4e05e343a5 76436-302 HUMAN OTC DRUG RUBBING ALCOHOL 50 PERCENT with Wintergreen ISOPROPYL ALCOHOL LIQUID TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333A Viny Health and Beauty Products Inc ISOPROPYL ALCOHOL 50 mL/100mL 76436-303_dc4c440c-e009-44ad-aa9d-19bf217e622f 76436-303 HUMAN OTC DRUG RUBBING ALCOHOL 70 PERCENT ISOPROPYL ALCOHOL LIQUID TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333A Viny Health and Beauty Products Inc ISOPROPYL ALCOHOL 70 mL/100mL 76436-304_e16a1709-e38c-4d63-9b95-e1084d3f77a7 76436-304 HUMAN OTC DRUG RUBBING ALCOHOL 70 PERCENT with Wintergreen ISOPROPYL ALCOHOL LIQUID TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333A Viny Health and Beauty Products Inc ISOPROPYL ALCOHOL 70 mL/100mL 76437-609_29f3069a-f2e2-4368-9698-d8b87fb3b8e9 76437-609 HUMAN OTC DRUG Reed Therapeutics Pain Relieving Therapy Methyl Salicylate, Menthol USP, Camphor GEL TOPICAL 20130109 OTC MONOGRAPH NOT FINAL part356 Reed Therapeutics CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE .2; 4; 12.5 g/100g; g/100g; g/100g 76437-609_bfbc2af5-0f4b-46cc-aae4-44d25994b14d 76437-609 HUMAN OTC DRUG Reed Therapeutics Pain Relieving Therapy Methyl Salicylate, Menthol USP, Camphor GEL TOPICAL 20130323 OTC MONOGRAPH NOT FINAL part356 Reed Therapeutics CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE .2; 4; 12.5 g/100g; g/100g; g/100g 76437-609_f1f6551d-a099-427f-a223-79a6151523ee 76437-609 HUMAN OTC DRUG Reed Therapeutics Pain Relieving Therapy Methyl Salicylate, Menthol USP, Camphor GEL TOPICAL 20130329 OTC MONOGRAPH NOT FINAL part356 Reed Therapeutics CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE .2; 4; 12.5 g/100g; g/100g; g/100g 76439-101_8268a098-c5e2-4558-93fd-17c64f5af19c 76439-101 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120112 ANDA ANDA062713 Virtus Pharmaceuticals, LLC CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 76439-102_8268a098-c5e2-4558-93fd-17c64f5af19c 76439-102 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120112 ANDA ANDA062713 Virtus Pharmaceuticals, LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] 76439-103_4fac215d-f2d9-4d23-a336-e8a5923e083e 76439-103 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120112 ANDA ANDA062058 Virtus Pharmaceuticals, LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 76439-104_4fac215d-f2d9-4d23-a336-e8a5923e083e 76439-104 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120112 ANDA ANDA062058 Virtus Pharmaceuticals, LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] 76439-107_8c63ec87-8a49-49b3-82ac-0672ea0d8764 76439-107 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET ORAL 20120701 ANDA ANDA078355 Virtus Pharmaceuticals DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] 76439-120_76d34f18-aab8-4c58-9903-32526c5c9c42 76439-120 HUMAN PRESCRIPTION DRUG acarbose acarbose TABLET ORAL 20131009 ANDA ANDA091343 Virtus Pharmaceuticals LLC ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 76439-121_76d34f18-aab8-4c58-9903-32526c5c9c42 76439-121 HUMAN PRESCRIPTION DRUG acarbose acarbose TABLET ORAL 20131009 ANDA ANDA091343 Virtus Pharmaceuticals LLC ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 76439-122_76d34f18-aab8-4c58-9903-32526c5c9c42 76439-122 HUMAN PRESCRIPTION DRUG acarbose acarbose TABLET ORAL 20131009 ANDA ANDA091343 Virtus Pharmaceuticals LLC ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] 76439-123_6732b231-8c92-4f82-a674-5f04c810a2d2 76439-123 HUMAN PRESCRIPTION DRUG glimepiride glimepiride TABLET ORAL 20131215 ANDA ANDA202112 Virtus Pharmaceuticals LLC GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 76439-124_6732b231-8c92-4f82-a674-5f04c810a2d2 76439-124 HUMAN PRESCRIPTION DRUG glimepiride glimepiride TABLET ORAL 20131215 ANDA ANDA202112 Virtus Pharmaceuticals LLC GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 76439-125_6732b231-8c92-4f82-a674-5f04c810a2d2 76439-125 HUMAN PRESCRIPTION DRUG glimepiride glimepiride TABLET ORAL 20131215 ANDA ANDA202112 Virtus Pharmaceuticals LLC GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] 76439-130_affd8073-4528-4bff-a09d-8bedf070d817 76439-130 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20131215 ANDA ANDA090258 Virtus Pharmaceuticals ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 76439-131_affd8073-4528-4bff-a09d-8bedf070d817 76439-131 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20131215 ANDA ANDA090258 Virtus Pharmaceuticals ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] 76439-134_d5c0a940-82b3-4c0c-bd5f-7d367c72c48c 76439-134 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET, FILM COATED ORAL 20131215 ANDA ANDA200958 Virtus Pharmaceuticals METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 76439-135_d5c0a940-82b3-4c0c-bd5f-7d367c72c48c 76439-135 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET, FILM COATED ORAL 20131215 ANDA ANDA200958 Virtus Pharmaceuticals METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 76439-136_56dafd4d-6fa6-4579-8634-e02ec978c37b 76439-136 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED ORAL 20140220 ANDA ANDA091498 Virtus Pharmaceuticals LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 76439-140_1f9cba87-afd4-48e6-9e9f-2d13a6cfd0ba 76439-140 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20140325 ANDA ANDA090382 Virtus Pharmaceuticals LLC LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 76439-141_1f9cba87-afd4-48e6-9e9f-2d13a6cfd0ba 76439-141 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20140325 ANDA ANDA090382 Virtus Pharmaceuticals LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 76439-142_1f9cba87-afd4-48e6-9e9f-2d13a6cfd0ba 76439-142 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20140325 ANDA ANDA090382 Virtus Pharmaceuticals LLC LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] 76439-201_924426c6-53c1-478c-ba34-058c18bd9c62 76439-201 HUMAN PRESCRIPTION DRUG Virt-Vite Forte folic acid, pyridoxine hydrochloride and cyanocobalamin TABLET, FILM COATED ORAL 20140409 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC CYANOCOBALAMIN; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE 2; 2.5; 25 mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 76439-205_a2ca9d47-8705-4817-94fd-4c64a13a2cb7 76439-205 HUMAN PRESCRIPTION DRUG L-Methylfolate Calcium LEVOMEFOLATE CALCIUM TABLET, COATED ORAL 20120315 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LEVOMEFOLATE CALCIUM 15 mg/1 76439-205_e6543530-df14-4d6a-b513-169387dd5513 76439-205 HUMAN PRESCRIPTION DRUG L-Methyl-B6-B12 Levomefolate Calcium, Pyridoxal 5-Phosphate, and Methylcobalamin TABLET, COATED ORAL 20120315 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; PYRIDOXAL 5-PHOSPHATE 15; 2; 35 mg/1; mg/1; mg/1 76439-206_f64314ca-7f56-4a57-9afe-f2100cfeded6 76439-206 HUMAN PRESCRIPTION DRUG L-Methylfolate Calcium LEVOMEFOLATE CALCIUM TABLET, COATED ORAL 20120315 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LEVOMEFOLATE CALCIUM 7.5 mg/1 76439-207_1ff89bb3-b424-40c8-9872-483a4ebdcdb9 76439-207 HUMAN PRESCRIPTION DRUG L-Methyl MC Levomefolate Calcium, Riboflavin, Cyanocobalamin, and Pyridoxine TABLET, COATED ORAL 20120301 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals CYANOCOBALAMIN; LEVOMEFOLATE CALCIUM; PYRIDOXINE; RIBOFLAVIN 1; 6; 50; 5 mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 76439-208_fa081c39-5fcb-4805-ae6c-4fae52b1bf4b 76439-208 HUMAN PRESCRIPTION DRUG L-Methyl MC NAC levomefolate calcium, methylcobalamin and acetylcysteine TABLET, COATED ORAL 20140409 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC ACETYLCYSTEINE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN 600; 6; 2 mg/1; mg/1; mg/1 Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 76439-209_973b81de-db5f-4569-b25d-2654385001d1 76439-209 HUMAN PRESCRIPTION DRUG Virt-Vite folic acid, pyridoxine hydrochloride and cyanocobalamin TABLET ORAL 20140104 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC CYANOCOBALAMIN; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE 1; 2.5; 25 mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 76439-210_3baa4138-2342-46d5-9f68-8d17823f5986 76439-210 HUMAN PRESCRIPTION DRUG Virt-Vite Plus folic acid, cyanocobalamin, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, niacinamide, ascorbic acid, calcium pantothenate and biotin TABLET ORAL 20140114 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE 60; 300; 10; 1; 5; 20; 50; 1.5; 1.5 mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 76439-217_1ba0b4be-b4be-4033-8113-f984ea3c037c 76439-217 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20140409 OTC MONOGRAPH FINAL part331 Virtus Pharmaceuticals LLC MAGNESIUM OXIDE 400 mg/1 76439-218_273b525b-7df7-42d8-a402-954802d1f5ac 76439-218 HUMAN PRESCRIPTION DRUG L-Methyl-B6-B12 Levomefolate Calcium, Pyridoxal 5-Phosphate, and Methylcobalamin TABLET, COATED ORAL 20120315 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; PYRIDOXAL 5-PHOSPHATE 15; 2; 35 mg/1; mg/1; mg/1 76439-221_59fa624c-0a99-4db5-9b28-e6e06d505e1f 76439-221 HUMAN PRESCRIPTION DRUG VP-ZEL Niacinamide, Azelaic Acid, Zinc, Pyridoxine, Cupric Oxide, and Folic Acid TABLET, COATED ORAL 20120301 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals AZELAIC ACID; CUPRIC OXIDE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; ZINC 5; 1.5; 500; 600; 5; 10 mg/1; mg/1; ug/1; mg/1; mg/1; mg/1 Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE] 76439-223_b372b9c4-f71a-4f0d-b1ce-6be07209f24c 76439-223 HUMAN PRESCRIPTION DRUG VP-PNV-DHA Folic Acid, Pyridoxine, Calcium Carbonate, Thiamine Mononitrate, Cholecalciferol, .Alpha.-Tocopherol, D-, Cyanocobalamin, Ferrous Fumarate, Magnesium Oxide, Riboflavin, Niacin, Ascorbic Acid, Cupric Sulfate, Vitamin A Palmitate, Zinc Oxide, Doconexent, and Ethyl Icosapentate CAPSULE, GELATIN COATED ORAL 20120401 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals .ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; DOCONEXENT; ETHYL ICOSAPENTATE; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM OXIDE; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A PALMITATE; ZINC OXIDE 30; 80; 50; 400; 1; 12; 200; 15.8; 28; 1; 30; 20; 16; 2.2; 6; 2500; 20 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC] 76439-224_568480c0-24e3-4593-b6ea-50b923e066e4 76439-224 HUMAN PRESCRIPTION DRUG VP-CH-PNV CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, DOCONEXENT, and ICOSAPENT CAPSULE ORAL 20120315 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals .ALPHA.-TOCOPHEROL ACETATE, DL-; CALCIUM CITRATE; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; ICOSAPENT; IRON PENTACARBONYL; PYRIDOXINE HYDROCHLORIDE 30; 104; 400; 260; 50; 1; 2.6; 30; 25 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 76439-225_0326b0d6-d3ea-4463-98be-a7cd1dcf5256 76439-225 HUMAN PRESCRIPTION DRUG Virt-Bal DHA Plus Folic Acid, Pyridoxine, Calcium Carbonate, Sodium Ascorbate, Cholecalciferol, Acetate Ion, Thiamine Mononitrate, Riboflavin, Niacinamide, Cyanocobalamin, Ferrous Bisglycinate Hydrochloride, Iodine, Zinc Oxide, Cupric Oxide, .Beta.-Carotene, Magnesium Oxide, Doconexent, and Icosapent KIT 20120712 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals 76439-226_88f25581-9825-4bad-8679-f3f31d647598 76439-226 HUMAN PRESCRIPTION DRUG V-Natal Folic Acid, pyridoxine, Calcium formate, Calcium carbonate, sodium ascorbate, cholecalciferol, acetate ion, thiamine mononitrate, riboflavin, niacinamide, cyanocobalamin, ferrous bisglycinate, potassium iodide, zinc oxide, and choline bitartrate TABLET, COATED ORAL 20120712 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals ACETATE ION; CALCIUM CARBONATE; CALCIUM FORMATE; CHOLECALCIFEROL; CHOLINE BITARTRATE; CYANOCOBALAMIN; FERROUS BISGLYCINATE; FOLIC ACID; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC OXIDE 30; 45; 155; 450; 55; 10; 32; 1000; 20; 100; 50; 3; 120; 3; 10 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 76439-230_c8bb97bf-1a30-4aaf-87b6-ff84173bfc7d 76439-230 HUMAN PRESCRIPTION DRUG Iron Polysaccharides Folic Acid DHA .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron dextran, potassium iodide, magnesium oxide, zinc oxide, cupric oxide and doconexent TABLET, FILM COATED ORAL 20131220 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; DOCONEXENT; FOLIC ACID; IRON DEXTRAN; MAGNESIUM OXIDE; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 20; 1100; 30; 1000; 2; 12; 200; 1; 29; 20; 15; 150; 2.5; 1.8; 1.6; 25 mg/1; [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 76439-232_a147459b-d68f-4c6c-989a-610f86ea1e3e 76439-232 HUMAN PRESCRIPTION DRUG VP-Precip linseed oil, evening primrose oil and bilberry CAPSULE, GELATIN COATED ORAL 20120518 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC BILBERRY; EVENING PRIMROSE OIL; LINSEED OIL 40; 500; 1000 mg/1; mg/1; mg/1 76439-233_8b23f206-43eb-454b-9608-b9cb985209cd 76439-233 HUMAN PRESCRIPTION DRUG VP-GGR-B6 pyridoxine hydrochloride, folic acid, calcium phosphate, dibasic, anhydrous, tricalcium phosphate and ginger TABLET ORAL 20130613 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; FOLIC ACID; GINGER; PYRIDOXINE HYDROCHLORIDE; TRICALCIUM PHOSPHATE 62.05; 1.2; 100; 40; 62.05 mg/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] 76439-237_8e5ec80f-4720-4dfe-9f9b-67b4e2b8a336 76439-237 HUMAN PRESCRIPTION DRUG VP-HEME OB cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, iron sucrose, heme iron polypeptide, potassium iodide, zinc oxide, sodium selenate and copper gluconate TABLET, FILM COATED ORAL 20131014 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC .ALPHA.-TOCOPHEROL SUCCINATE, D-; BIOTIN; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; COPPER GLUCONATE; CYANOCOBALAMIN; FOLIC ACID; HEME IRON POLYPEPTIDE; IRON SUCROSE; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM SELENATE; THIAMINE MONONITRATE; ZINC OXIDE 10; 30; 10; 400; .8; 12; 1; 6; 28; 17; 250; 50; 1.6; 65; 1.5; 4.5 [iU]/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 76439-238_d3fff3b8-44b7-44b9-8dc7-2c734bc1eb41 76439-238 HUMAN PRESCRIPTION DRUG VP-HEME OB DHA beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide,omega-3 fatty acids KIT ORAL 20131201 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC 76439-240_ed6b58f2-da48-4173-853b-7b24b463e92d 76439-240 HUMAN PRESCRIPTION DRUG VP-HEME One folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent capsule, gelatin CAPSULE, GELATIN COATED ORAL 20130301 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FOLIC ACID; HEME IRON POLYPEPTIDE; IRON SUCROSE; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; ZINC OXIDE 10; 25; 30; 10; 400; 12; 200; 1; 6; 22; 17; 175; 50; 15 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC] 76439-241_962ae7d1-8a70-4ed2-a809-733d72f93223 76439-241 HUMAN PRESCRIPTION DRUG Virt-Pn LEVOMEFOLIC ACID, PYRIDOXINE, .BETA.-CAROTENE, CALCIUM CARBONATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, CYANOCOBALAMIN, FERROUS FUMARATE, POTASSIUM IODIDE, ZINC OXIDE, BIOTIN, CALCIUM PANTOTHENATE, MAGNESIUM OXIDE, and CUPRIC OXIDE TABLET, COATED ORAL 20120712 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals .ALPHA.-TOCOPHEROL; .BETA.-CAROTENE; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; LEVOMEFOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 10; 2500; 80; 300; 120; 6; 400; 2; 12; 27; 1; 30; 20; 150; 20; 3.4; 3; 15 [iU]/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 76439-242_ae8d74a6-0265-4ff2-b656-7f771e671b58 76439-242 HUMAN PRESCRIPTION DRUG VP CH Plus calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium and doconexent CAPSULE, GELATIN COATED ORAL 20140409 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; CALCIUM CITRATE; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON PENTACARBONYL; PYRIDOXINE HYDROCHLORIDE 30; 104; 400; 265; 50; 1; 29; 25 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 76439-243_1189d7d6-d0ee-4576-a531-effb52ba7d8b 76439-243 HUMAN PRESCRIPTION DRUG Virt-PN Plus folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent CAPSULE, GELATIN COATED ORAL 20130301 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC .ALPHA.-TOCOPHEROL; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; ICOSAPENT; MAGNESIUM OXIDE; POTASSIUM IODIDE; PYRIDOXINE 10; 85; 250; 140; 200; 12; 300; 28; 1; 40; 45; 150; 25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 76439-244_45e09e7f-6db8-4ba2-bdbc-322c370df79f 76439-244 HUMAN PRESCRIPTION DRUG NATALVIRT CA CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, POTASSIUM IODIDE, ZINC OXIDE, CUPRIC OXIDE, and DOCONEXENT KIT 20130115 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals 76439-245_ded2c146-91d4-4986-90be-aa667aeb5b3b 76439-245 HUMAN PRESCRIPTION DRUG NATALVIRT 90DHA CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, ASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, IODINE, ZINC, COPPER, and DOCONEXENT KIT 20130115 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals 76439-247_e75c64e6-9c5e-4001-a164-993248b89a07 76439-247 HUMAN PRESCRIPTION DRUG Natalvirt FLT ferrous gluconate, folic acid, cyanocobalamin, ascorbic acid and docusate sodium TABLET, FILM COATED ORAL 20130401 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC ASCORBIC ACID; CYANOCOBALAMIN; DOCUSATE SODIUM; FERROUS GLUCONATE; FOLIC ACID 120; 12; 50; 90; 1 mg/1; ug/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 76439-249_d2bfd061-a2d4-4c42-898d-329956b6349e 76439-249 HUMAN PRESCRIPTION DRUG Virt-Select Folic Acid, Pyridoxine, Calcium Phosphate, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol, D-, Ferrous Fumarate, Docusate Sodium, and Doconexent CAPSULE, GELATIN COATED ORAL 20121018 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals .ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CALCIUM PHOSPHATE; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; PYRIDOXINE 30; 28; 160; 800; 325; 55; 29; 1.25; 25 [iU]/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 76439-251_d426fcad-0b68-4412-b5bb-0187892f07eb 76439-251 HUMAN PRESCRIPTION DRUG Extra-Virt Plus DHA ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, folic acid, biotin, calcium carbonate, docusate calcium, ferrous fumarate and doconexent CAPSULE, GELATIN COATED ORAL 20121228 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC .ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE CALCIUM; FERROUS FUMARATE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE 30; 28; 250; 158; 800; 350; 55; 29; 1; 25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 76439-252_1f7db699-8b83-450e-8ff8-c44f3247e1a3 76439-252 HUMAN OTC DRUG Virtussin AC Codeine Phosphate and Guaifenesin LIQUID ORAL 20131211 OTC MONOGRAPH FINAL part341 Virtus Pharmaceuticals LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL 76439-252_58aaee70-a0dc-495b-8bfc-80d7ee7ac622 76439-252 HUMAN OTC DRUG Virtussin AC Codeine Phosphate and Guaifenesin LIQUID ORAL 20140409 OTC MONOGRAPH FINAL part341 Virtus Pharmaceuticals LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV 76439-253_71f47a1e-c757-490d-bea6-ab556f57b2b5 76439-253 HUMAN OTC DRUG Virtussin DAC Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride LIQUID ORAL 20141121 OTC MONOGRAPH FINAL part341 Virtus Pharmaceuticals CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 100; 30 mg/5mL; mg/5mL; mg/5mL CV 76439-258_d68362a4-05ca-4062-8863-62c5a2d8177a 76439-258 HUMAN PRESCRIPTION DRUG PrePLUS .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide and cupric oxide TABLET ORAL 20140404 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 22; 4000; 120; 200; 400; 2; 12; 27; 1; 20; 10; 3; 1.84; 25 mg/1; [iU]/1; mg/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 76439-259_3c2df670-f894-48e5-b08a-6ad5d293429b 76439-259 HUMAN PRESCRIPTION DRUG PreTAB .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, potassium iodide and zinc oxide TABLET ORAL 20140409 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 30; 4000; 120; 200; 400; 8; 29; 1; 20; 150; 3; 3; 3; 15 [iU]/1; [iU]/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] 76439-260_2d207dad-c8bf-44d9-9065-692a3ea5217b 76439-260 HUMAN PRESCRIPTION DRUG Virt-Caps ascorbic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin and calcium pantothenate CAPSULE, GELATIN COATED ORAL 20140401 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE 100; 150; 5; 6; 1; 20; 10; 1.7; 1.5 mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 76439-261_a781b3ec-f20d-47d2-b696-06d44522ba52 76439-261 HUMAN PRESCRIPTION DRUG Potassium Citrate Citric Acid Crystals Potassium Citrate and Citric Acid GRANULE, FOR SOLUTION ORAL 20140613 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC CITRIC ACID MONOHYDRATE; POTASSIUM CITRATE 1.002; 3.3 g/1; g/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 76439-269_c4a3b80a-26d8-430c-9b7c-2e6de0fb2e7b 76439-269 HUMAN PRESCRIPTION DRUG Niaacinamide Azelaic AC TURMER FA B6 Zinc Ox Copper Niacinamide Azelaic AC TURMER FA B6 Zinc Ox Copper TABLET, COATED ORAL 20140509 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC CUPRIC OXIDE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; ZINC OXIDE 2; 500; 700; 8; 12 mg/1; ug/1; mg/1; mg/1; mg/1 Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 76439-273_0f8e6147-cffc-4a22-b644-d049d8c698b3 76439-273 HUMAN PRESCRIPTION DRUG PNV Ferrous Fumarate Docusate Folic Acid PNV Ferrous Fumarate Docusate Folic Acid TABLET ORAL 20140422 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ASCORBIC ACID; CALCIUM CARBONATE; CALCIUM PANTOTHENATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCUSATE SODIUM; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE 30; 1000; 100; 200; 7; 400; 12; 25; 29; 1; 15; 20; 3; 3; 20 [iU]/1; [iU]/1; mg/1; mg/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] 76439-274_12f8a334-39f5-4106-941d-5ca6efbb7040 76439-274 HUMAN PRESCRIPTION DRUG VP CH Ultra calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium and doconexent CAPSULE, GELATIN COATED ORAL 20140414 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC .ALPHA.-TOCOPHEROL ACETATE, DL-; CALCIUM CITRATE; CHOLECALCIFEROL; DOCONEXENT; DOCUSATE SODIUM; FOLIC ACID; IRON PENTACARBONYL; PYRIDOXINE HYDROCHLORIDE 30; 104; 400; 260; 50; 1; 27; 25 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] 76439-302_a03ca7ef-3035-4e81-a581-68615d1e7a56 76439-302 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride/Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20120608 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] 76439-304_cc9f7c11-866b-406f-b827-abb995b04458 76439-304 HUMAN PRESCRIPTION DRUG Antipyrine and Benzocaine Antipyrine and Benzocaine SOLUTION AURICULAR (OTIC) 20120912 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals ANTIPYRINE; BENZOCAINE 55; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 76439-305_8cd9f27c-5616-4e46-8d2c-183c20c0cf4b 76439-305 HUMAN PRESCRIPTION DRUG Antipyrine and Benzocaine Antipyrine and Benzocaine LIQUID TOPICAL 20120912 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals ANTIPYRINE; BENZOCAINE 54; 14 mg/mL; mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] 76439-307_98e3c1cf-091e-4912-8caa-c296ca58318a 76439-307 HUMAN PRESCRIPTION DRUG hyoscyamine sulfate hyoscyamine sulfate TABLET, ORALLY DISINTEGRATING ORAL 20110904 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals HYOSCYAMINE SULFATE .125 mg/1 76439-308_4a7c0244-c7d1-42b1-8fea-8a94f63489ff 76439-308 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL 20110904 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals HYOSCYAMINE SULFATE .125 mg/1 76439-309_60e454ff-c132-4435-b1f7-fbff7d1b4391 76439-309 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate SL Hyoscyamine Sulfate TABLET ORAL 20110904 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals HYOSCYAMINE SULFATE .125 mg/1 76439-321_78a0757b-9a09-4bf9-a0e2-1730f15ef1ec 76439-321 HUMAN PRESCRIPTION DRUG Virti-SULF SULFACETAMIDE SODIUM AND SULFUR CREAM TOPICAL 20120912 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 76439-322_81292445-7c41-4c3e-93cb-5b0ef280da56 76439-322 HUMAN PRESCRIPTION DRUG levomefolate calcium and schizochytrium dha Levomefolate Calcium and Algal Powder CAPSULE ORAL 20130613 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LEVOMEFOLATE CALCIUM; SCHIZOCHYTRIUM DHA OIL 15; 90.314 mg/1; mg/1 76439-323_66b8781a-6c11-4cf2-81c6-ee36f3e764d8 76439-323 HUMAN PRESCRIPTION DRUG levomefolate calcium and schizochytrium dha Levomefolate Calcium and Algal Powder CAPSULE ORAL 20130613 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LEVOMEFOLATE CALCIUM; SCHIZOCHYTRIUM DHA OIL 7.5; 90.314 mg/1; mg/1 76439-324_ebce1ffd-5df2-4e18-853b-95665e459a96 76439-324 HUMAN PRESCRIPTION DRUG Levomefolate Calcium, Acetylcysteine, Mecobalamin and Algal levomefolate calcium, methylcobalamin, acetylcysteine and schizochytrium dha oil TABLET ORAL 20130613 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC ACETYLCYSTEINE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; SCHIZOCHYTRIUM DHA OIL 600; 6; 2; 90.314 mg/1; mg/1; mg/1; mg/1 Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 76439-325_45633453-c5d7-4c31-a0fd-05b64152aaf6 76439-325 HUMAN PRESCRIPTION DRUG levomefolate calcium, pyridoxal 5-phosphate, methylcobalamin and schizochytrium dha oil Levomefolate Calcium and Algal Powder CAPSULE ORAL 20130613 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; PYRIDOXAL 5-PHOSPHATE; SCHIZOCHYTRIUM DHA OIL 3; 2; 35; 90.314 mg/1; mg/1; mg/1; mg/1 76439-326_fb842e29-0c11-4541-887e-7f354a19b7a0 76439-326 HUMAN PRESCRIPTION DRUG levomefolate calcium, cyanocobalamin and pyridoxine hydrochloride levomefolate calcium, cyanocobalamin and pyridoxine hydrochloride TABLET ORAL 20140613 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC CYANOCOBALAMIN; LEVOMEFOLATE CALCIUM; PYRIDOXINE HYDROCHLORIDE 2; 1.13; 25 mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] 76439-329_15267184-6f61-41ef-98fa-b039c66b3bfe 76439-329 HUMAN PRESCRIPTION DRUG Levomefolate Calcium Acetylcysteine and Mecobalamin Algal levomefolate calcium, methylcobalamin, acetylcysteine and schizochytrium TABLET, COATED ORAL 20140509 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals ACETYLCYSTEINE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; SCHIZOCHYTRIUM DHA OIL 600; 6; 2; 90.314 mg/1; mg/1; mg/1; mg/1 Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] 76439-340_8352bf3b-c6ec-4790-88ec-88ed2d99438c 76439-340 HUMAN PRESCRIPTION DRUG Virt-Pn DHA LEVOMEFOLATE CALCIUM, PYRIDOXINE, CALCIUM CARBONATE, SODIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, D-, CYANOCOBALAMIN, FERROUS FUMARATE, MAGNESIUM OXIDE, and DOCONEXENT CAPSULE, GELATIN COATED ORAL 20120712 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals .ALPHA.-TOCOPHEROL, D-; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; LEVOMEFOLATE CALCIUM; MAGNESIUM OXIDE; PYRIDOXINE; SODIUM ASCORBATE 10; 140; 200; 12; 300; 27; 1; 45; 25; 85 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA] 76439-343_9167d9c2-5507-48a5-ab03-3fc9210c6dd9 76439-343 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride POWDER, FOR SOLUTION ORAL 20131009 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC POTASSIUM CHLORIDE 1.5 g/1.74g Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 76439-345_90bd3d30-cca1-4d90-b294-7283e46fea65 76439-345 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride POWDER, FOR SOLUTION ORAL 20140613 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC POTASSIUM CHLORIDE 25 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] 76441-902_7cd2f3b6-3b50-4a00-99d5-86d7dd298efa 76441-902 HUMAN OTC DRUG Licel Piperonly Butoxide, Pyrethrum Extract OIL TOPICAL 20120620 OTC MONOGRAPH FINAL part358G Sujanil Chemo Industries PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL 76441-903_dbfbc2a6-6e3b-4aff-bf91-3747563a1f5a 76441-903 HUMAN OTC DRUG Lice-Nil Lice and Eggs Killer Piperonly Butoxide, Pyrethrum Extract OIL TOPICAL 20130618 OTC MONOGRAPH FINAL part358G Sujanil Chemo Industries PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL 76446-001_27b238db-0a0e-4591-8668-6ca1d2ef6ab7 76446-001 HUMAN OTC DRUG Anna Lotan Triple Benefit Tinted Moisturizing Day Broad Spectrum SPF 30 OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20120119 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 2.5; 6.65 mL/100mL; mL/100mL; mL/100mL 76446-002_1d1b99c6-cf1a-4c46-bf5b-90b8e43c07c3 76446-002 HUMAN OTC DRUG ANNA LOTAN Premium B.B. UVA UVB SPF 36 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20120616 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd OCTINOXATE; TITANIUM DIOXIDE 15; 30 mL/100mL; mL/100mL 76446-003_a541893c-e891-4f26-adbb-a7e9da4b341b 76446-003 HUMAN OTC DRUG ANNA LOTAN Clear Protector Free Broad Spectrum SPF 32 Sunscreen HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE GEL TOPICAL 20120616 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.75; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL 76446-004_a5fe9557-9e8e-4c54-9eb1-d419892ca74b 76446-004 HUMAN OTC DRUG ANNA LOTAN Rejuvenating Day Broad Spectrum SPF 34 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120619 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd OCTINOXATE; TITANIUM DIOXIDE 7.5; 4.4 mL/100mL; mL/100mL 76446-005_d6b3298e-b647-4eb3-9abe-c0dfacde3ef6 76446-005 HUMAN OTC DRUG anna lotan PRO CC Color Control SPF25 Broad Spectrum Protection for All Skin Types TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20131111 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd OCTINOXATE; TITANIUM DIOXIDE 75; 110 mg/mL; mg/mL 76446-006_2c9dd40c-bfdd-4793-b2e1-8f695f5a3de3 76446-006 HUMAN OTC DRUG anna lotan PRO PORCELAIN COVER SPF32 Tinted with Broad Spectrum Protection for All Skin Types TITANIUM DIOXIDE, OCTINOXATE LOTION TOPICAL 20131111 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd OCTINOXATE; TITANIUM DIOXIDE 75; 134 mg/mL; mg/mL 76446-007_1e6a2703-6fdb-4e1d-9887-afb0c2a2a569 76446-007 HUMAN OTC DRUG anna lotan PRO Protective LIGHTENING CARE UVA/UVB SPF 15 For Sun Damaged Skin OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20131111 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 70; 30; 21 mg/mL; mg/mL; mg/mL 76449-050_8d673888-8afe-4340-a182-05dfedc64ece 76449-050 HUMAN OTC DRUG Blemish Control Blotting Paper Salicylic Acid STRIP TOPICAL 20111215 OTC MONOGRAPH FINAL part358H NYX Los Angeles Inc. SALICYLIC ACID .03 mg/1 76450-050_fbc5a4ec-466f-476f-97d5-4e86c0e5f660 76450-050 HUMAN OTC DRUG MOISTURISING SUN PROTECTION SPF50 OCTINOXATE LOTION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Mesoestetic, S.L. AVOBENZONE; ENSULIZOLE; ENZACAMENE; OCTINOXATE 1.5; 1; 1.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL 76450-051_2a6178b0-752d-4ebd-ab95-2c002b5d5616 76450-051 HUMAN OTC DRUG DERMATOLOGICAL SUN PROTECTION OCTINOXATE LOTION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Mesoestetic, S.L. AVOBENZONE; ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 1.75; 1.5; 3.75; 3; 2; 3.5 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL 76452-001_d2e425f0-6031-4ba8-9b3a-49298b96570b 76452-001 HUMAN OTC DRUG Zaliex ALCOHOL-FREE Antiseptic Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part333E SAS Healthcare Inc BENZALKONIUM CHLORIDE .13 mL/100mL 76452-002_7318b746-f215-4ac9-9d0e-d2a71658134f 76452-002 HUMAN OTC DRUG Zaliex Antiseptic Hand BENZALKONIUM CHLORIDE SOAP TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part333E SAS Healthcare Inc BENZALKONIUM CHLORIDE .13 mg/mL 76452-003_170f4fa5-da5d-4caf-8a7b-8f5ebfd00445 76452-003 HUMAN OTC DRUG Zaliex Alcohol-Free Antiseptic Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120913 OTC MONOGRAPH NOT FINAL part333E SAS Healthcare Inc BENZALKONIUM CHLORIDE .13 mg/mL 76452-004_2b543a16-e2bf-4b00-822e-01326f57cd0e 76452-004 HUMAN OTC DRUG Zaliex Alcohol-Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part333E SAS Healthcare Inc BENZALKONIUM CHLORIDE .1 mg/.001L 76454-100_698fa2f5-9044-430a-a8a0-aed3d056bd53 76454-100 HUMAN OTC DRUG NATURES GUM BALM SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20111001 20181001 OTC MONOGRAPH FINAL part355 Widepipe Corp SODIUM MONOFLUOROPHOSPHATE 8.4 mg/g 76454-101_8fa43213-34bb-4291-9560-ed59d4daf16b 76454-101 HUMAN OTC DRUG NATURES SMILE SODIUM FLUORIDE MOUTHWASH DENTAL 20111001 20181001 OTC MONOGRAPH FINAL part355 Widepipe Corp SODIUM FLUORIDE .2 mg/mL 76457-001_943e1fc5-dee8-435c-981a-c87c09aea5aa 76457-001 HUMAN OTC DRUG Aluminum hydroxide and Magnesium carbonate ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE TABLET, CHEWABLE ORAL 20121115 OTC MONOGRAPH FINAL part331 Simpex Pharma Pvt. Ltd ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 76457-002_02ac9591-9bec-49ef-8751-feb461860024 76457-002 HUMAN OTC DRUG diphenhydramine hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20121115 OTC MONOGRAPH FINAL part341 Simpex Pharma Pvt. Ltd DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 76457-003_c31b1400-a62b-4319-84ff-f76c5e86b3b9 76457-003 HUMAN OTC DRUG SIMPEX Bisacodyl laxative BISACODYL TABLET, COATED ORAL 20131107 OTC MONOGRAPH NOT FINAL part334 Simpex Pharma Pvt. Ltd BISACODYL 5 mg/1 76457-004_32ab94e5-e61a-4831-97aa-42e92840da7e 76457-004 HUMAN OTC DRUG SIMPEX Guaifenesin GUAIFENESIN TABLET ORAL 20131107 OTC MONOGRAPH FINAL part341 Simpex Pharma Pvt. Ltd GUAIFENESIN 400 mg/1 76458-201_05a63c49-1974-4b26-b070-b32813cb0852 76458-201 HUMAN OTC DRUG Light Day Sunscreen Broad Spectrum SPF 37 Avobenzone, Octinoxate and Octocrylene LOTION TOPICAL 20120715 OTC MONOGRAPH NOT FINAL part352 Circadia by Dr Pugliese, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE .03; .075; .028 mL/mL; mL/mL; mL/mL 76458-333_fb4cc832-4cfd-4e29-a78e-ab848681a224 76458-333 HUMAN OTC DRUG Nighttime Control Benzoyl Peroxide LOTION TOPICAL 20120715 OTC MONOGRAPH NOT FINAL part333D Circadia by Dr Pugliese, Inc. BENZOYL PEROXIDE .05 mL/mL 76461-003_1ff5bbec-0496-4cc1-9122-ec77c82adf70 76461-003 HUMAN OTC DRUG SMITH BROS NON-DROWSY DAY TIME COLD and FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE POWDER, FOR SOLUTION ORAL 20140709 OTC MONOGRAPH FINAL part341 Universal Holdings I LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 76461-004_f5a4e5fd-3b0c-4f47-8380-cf49a5c777fd 76461-004 HUMAN OTC DRUG SMITH BROS NON-DROWSY MULTI-SYMPTOM COLD and FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE POWDER, FOR SOLUTION ORAL 20140705 OTC MONOGRAPH FINAL part341 Universal Holdings I LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 76461-005_5a57ca54-7452-447a-b158-1c8b83fd8396 76461-005 HUMAN OTC DRUG SMITH BROS NIGHT TIME COUGH and CONGESTION ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE POWDER, FOR SOLUTION ORAL 20140709 OTC MONOGRAPH FINAL part341 Universal Holdings I LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 12.5; 10 mg/1; mg/1; mg/1; mg/1 76461-020_4b3befd8-e067-4288-803f-36566fc4b0e9 76461-020 HUMAN OTC DRUG SMITH BROS Sugar-Free BLACK CHERRY Cough Drops MENTHOL LOZENGE ORAL 20130523 OTC MONOGRAPH FINAL part341 Universal holdings I LLC dba Smith Brothers Company MENTHOL 5.8 mg/1 76461-021_514205c8-131e-42bf-bc0b-d245849b9cc2 76461-021 HUMAN OTC DRUG SMITH BROS WILD CHERRY Throat Drops PECTIN LOZENGE ORAL 20130523 OTC MONOGRAPH NOT FINAL part356 Universal holdings I LLC dba Smith Brothers Company PECTIN 2.8 mg/1 76461-022_766a01f9-6b88-4776-ba6e-3a1f416a0da8 76461-022 HUMAN OTC DRUG SMITH BROS BLACK LICORICE Throat Drops PECTIN LOZENGE ORAL 20130523 OTC MONOGRAPH NOT FINAL part356 Universal holdings I LLC dba Smith Brothers Company PECTIN 2.8 mg/1 76461-023_16c425fa-b51d-4950-8f90-070d0fdf7159 76461-023 HUMAN OTC DRUG SMITH BROS HONEY LEMON Cough Drops MENTHOL LOZENGE ORAL 20130523 OTC MONOGRAPH FINAL part341 Universal holdings I LLC dba Smith Brothers Company MENTHOL 9.1 mg/1 76461-024_c5e1a805-a5b2-4827-8788-d50224725c36 76461-024 HUMAN OTC DRUG SMITH BROS MENTHOL EUCALYPTUS Cough Drops MENTHOL LOZENGE ORAL 20130523 OTC MONOGRAPH FINAL part341 Universal holdings I LLC dba Smith Brothers Company MENTHOL 6.5 mg/1 76461-114_3ec25d28-eae5-4945-b825-a1b976fc503c 76461-114 HUMAN OTC DRUG SMITH BROS WARM APPLE PIE WITH CINNAMON FLAVOR BEADS Warming Throat Drops PECTIN LOZENGE ORAL 20130523 OTC MONOGRAPH NOT FINAL part356 Universal holdings I LLC dba Smith Brothers Company PECTIN 2 mg/1 76461-500_b5de2c76-66e6-4c88-93ca-d13281448a01 76461-500 HUMAN OTC DRUG SMITH BROS WILD CHERRY DAY TIME with Caffeine Soothing Drops CAFFEINE LOZENGE ORAL 20130529 OTC MONOGRAPH FINAL part340 Universal holdings I LLC dba Smith Brothers Company CAFFEINE 50 mg/1 76461-598_189db144-fa41-4831-a2ff-c51a894886fc 76461-598 HUMAN OTC DRUG PharmaRight Extra Strength Antacid PEPPERMINT CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20130529 OTC MONOGRAPH FINAL part331 Universal holdings I LLC dba Smith Brothers Company CALCIUM CARBONATE 750 mg/1 76461-599_75ce0328-e434-4ae7-9773-192986e10d42 76461-599 HUMAN OTC DRUG PharmaRight Extra Strength Antacid ASSORTED FRUIT CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20130529 OTC MONOGRAPH FINAL part331 Universal holdings I LLC dba Smith Brothers Company CALCIUM CARBONATE 750 mg/1 76461-910_d1304e5b-559b-41b9-a43c-b3019f2b0745 76461-910 HUMAN OTC DRUG SMITH BROS WILD CHERRY Throat Drops PECTIN LOZENGE ORAL 20130523 OTC MONOGRAPH NOT FINAL part356 Universal holdings I LLC dba Smith Brothers Company PECTIN 1.7 mg/1 76461-915_d131b3ca-ba87-4ecb-9427-b1326264477b 76461-915 HUMAN OTC DRUG SMITH BROS BLACK LICORICE Throat Drops PECTIN LOZENGE ORAL 20130523 OTC MONOGRAPH NOT FINAL part356 Universal holdings I LLC dba Smith Brothers Company PECTIN 1.7 mg/1 76463-585_88a9eb0a-d10f-4060-9f3c-e06187864c3e 76463-585 HUMAN OTC DRUG Foam Aid ALCOHOL LIQUID TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part333E Gil Manufacturing, Inc. ALCOHOL .62 mL/mL 76464-001_c4b4600a-351e-4593-9f26-090a05ef78b9 76464-001 HUMAN OTC DRUG Chopper Chap Lip Balm Octinoxate, Oxybenzone STICK TOPICAL 20060408 OTC MONOGRAPH NOT FINAL part352 Cruising Chrome Cosmetics, LLC OCTINOXATE; OXYBENZONE 70; 30 mg/g; mg/g 76466-010_00f75b55-0728-47b7-95fe-1a2c8cedc524 76466-010 HUMAN OTC DRUG VAGI-CURE (MAXIMUM STRENGTH) BENZOCAINE, RESORCINOL CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part348 SCI International, Inc. DBA Continental Pharmaceuticals BENZOCAINE; RESORCINOL 200; 30 mg/g; mg/g 76466-075_78c63339-9b07-4445-b7cb-be970b3216b7 76466-075 HUMAN OTC DRUG VAGI-CURE (REGULAR STRENGTH) BENZOCAINE, BENZALKONIUM CHLORIDE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part348 SCI International, Inc. DBA Continental Pharmaceuticals BENZALKONIUM CHLORIDE; BENZOCAINE .13; 50 mg/g; mg/g 76466-500_c77b5c0b-972b-475c-bed3-0117d47842c0 76466-500 HUMAN OTC DRUG Well at Walgreens Anti-Itch Maximum Strength Benzocaine and Resorcinol CREAM TOPICAL 20140519 OTC MONOGRAPH FINAL part346 SCI International BENZOCAINE; RESORCINOL 200; 30 mg/g; mg/g 76468-121_460dfdb8-48a4-4980-9180-a47a55047068 76468-121 HUMAN OTC DRUG REZIL CAPSAICIN LOTION TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part348 Toqara, Inc. CAPSAICIN .025 mL/100mL 76470-002_2c7f4b5f-07b5-48b0-9f90-d71ffb2cebbb 76470-002 HUMAN OTC DRUG EZ2go Stimu-Lax MAGNESIUM CITRATE POWDER, FOR SOLUTION ORAL 20111101 OTC MONOGRAPH FINAL part331 Valley Medical Products, LLC MAGNESIUM CITRATE 17 g/17g 76470-003_ae774fac-70e1-4e66-858b-acd1cbdafa0d 76470-003 HUMAN OTC DRUG EZ2go Zero DIMETHICONE TABLET ORAL 20111101 OTC MONOGRAPH FINAL part332 Valley Medical Products, LLC DIMETHICONE 80 mg/1 76470-004_4c6d1760-38d1-462d-a339-b753ba6f4ee9 76470-004 HUMAN OTC DRUG EZ2go Stimu-Lax BISACODYL TABLET ORAL 20120401 OTC MONOGRAPH NOT FINAL part334 Valley Medical Products, LLC BISACODYL 5 mg/5mg 76470-005_2cb78293-bb32-4052-ad6a-f86dbe2440d0 76470-005 HUMAN OTC DRUG EZ2go POLYETHYLENE GLYCOL 3350 POWDER ORAL 20121020 ANDA ANDA091077 Valley Medical Products,LLC POLYETHYLENE GLYCOL 3350 17 g/17g 76470-006_182890e3-612d-436c-b741-253e517fb85a 76470-006 HUMAN OTC DRUG EZ2go PEG 3350 POLYETHYLENE GLYCOL 3350 POWDER ORAL 20121020 ANDA ANDA091077 Valley Medical Products,LLC POLYETHYLENE GLYCOL 3350 17 g/17g 76472-1123_1617a49a-cf00-4765-8e9a-1551f0d1e67d 76472-1123 HUMAN OTC DRUG ACONITUM NAPELLUS ACONITUM NAPELLUS PELLET SUBLINGUAL 20111212 UNAPPROVED HOMEOPATHIC BrandStorm HBC ACONITUM NAPELLUS 30 [hp_C]/1 76472-1124_32f2fe50-8e57-4f83-92d3-3f775eede19b 76472-1124 HUMAN OTC DRUG Allium Cepa Allium Cepa PELLET SUBLINGUAL 20111120 UNAPPROVED HOMEOPATHIC BrandStorm HBC ONION 30 [hp_C]/1 76472-1125_79396a6b-5278-4261-87a6-02360cbcbcb4 76472-1125 HUMAN OTC DRUG APIS MELLIFERA APIS MELLIFERA PELLET SUBLINGUAL 20111123 UNAPPROVED HOMEOPATHIC BrandStorm HBC APIS MELLIFERA 30 [hp_C]/1 76472-1126_3c443a40-bf05-4155-b2a0-fbb4ca4ee43c 76472-1126 HUMAN OTC DRUG Argentum Nitricum SILVER NITRATE PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC SILVER NITRATE 30 [hp_C]/1 76472-1127_5a5c26f3-8521-4320-8fac-61102d901bd4 76472-1127 HUMAN OTC DRUG Arnica 12c ARNICA MONTANA PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC ARNICA MONTANA 12 [hp_C]/1 76472-1128_042e139a-c9ea-48be-b76d-4fd060400889 76472-1128 HUMAN OTC DRUG Arnica ARNICA MONTANA PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC ARNICA MONTANA 200 {kp_C}/1 76472-1129_0ceee6b9-8e97-4bea-9aa9-9e861079b6b1 76472-1129 HUMAN OTC DRUG Arnica 30c ARNICA MONTANA PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC ARNICA MONTANA 30 [hp_C]/1 76472-1130_5481a0b1-50ed-498d-b226-2ddf38fdeffb 76472-1130 HUMAN OTC DRUG Arnica ARNICA MONTANA PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC ARNICA MONTANA 30 [hp_X]/1 76472-1131_e74ca016-b585-45b1-9f8c-3239b3885601 76472-1131 HUMAN OTC DRUG Arnica 6c ARNICA MONTANA PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC ARNICA MONTANA 6 [hp_C]/1 76472-1132_dc76db68-cf76-4a23-adf8-24c99b9cb456 76472-1132 HUMAN OTC DRUG Arsenicum Album 30c ARSENIC TRIOXIDE PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC ARSENIC TRIOXIDE 30 [hp_C]/1 76472-1133_2e633f05-1fee-4914-9658-cd0f5bed2daf 76472-1133 HUMAN OTC DRUG Belladonna ATROPA BELLADONNA PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC ATROPA BELLADONNA 30 [hp_C]/1 76472-1134_2ffbac3c-1188-460d-90fb-229097feca2c 76472-1134 HUMAN OTC DRUG Borax SODIUM BORATE PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC SODIUM BORATE 30 [hp_C]/1 76472-1135_9d048d56-430c-4747-9f52-b37e70917a8d 76472-1135 HUMAN OTC DRUG Bryonia Alba 30c BRYONIA ALBA ROOT PELLET SUBLINGUAL 20111122 UNAPPROVED HOMEOPATHIC BrandStorm HBC BRYONIA ALBA ROOT 30 [hp_C]/1 76472-1136_04f02fa6-3d5c-4d02-941d-56639f6f3fd0 76472-1136 HUMAN OTC DRUG Calcarea Carbonic 30c OYSTER SHELL CALCIUM CARBONATE, CRUDE PELLET SUBLINGUAL 20111122 UNAPPROVED HOMEOPATHIC BrandStorm HBC OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_C]/1 76472-1137_152f84e7-2efd-4570-a2e0-107fe90a9f90 76472-1137 HUMAN OTC DRUG Calcarea Sulphurica 30c CALCIUM SULFATE ANHYDROUS PELLET SUBLINGUAL 20111122 UNAPPROVED HOMEOPATHIC BrandStorm HBC CALCIUM SULFATE ANHYDROUS 30 [hp_C]/1 76472-1138_613a507c-f578-4220-bd58-27108fa42986 76472-1138 HUMAN OTC DRUG Cantharis 30c LYTTA VESICATORIA PELLET SUBLINGUAL 20111122 UNAPPROVED HOMEOPATHIC BrandStorm HBC LYTTA VESICATORIA 30 [hp_C]/1 76472-1139_81277024-40a6-4f88-a539-64d39e303cf8 76472-1139 HUMAN OTC DRUG Carbo Vegetabilis 30c ACTIVATED CHARCOAL PELLET SUBLINGUAL 20111122 UNAPPROVED HOMEOPATHIC BrandStorm HBC ACTIVATED CHARCOAL 30 [hp_C]/1 76472-1140_70b7a93f-352e-477b-8c05-5be111c651a3 76472-1140 HUMAN OTC DRUG Chamomilla 30c MATRICARIA RECUTITA PELLET SUBLINGUAL 20111124 UNAPPROVED HOMEOPATHIC BrandStorm HBC MATRICARIA RECUTITA 30 [hp_C]/1 76472-1141_82fef432-e3d3-4f94-9dc0-713332498b7a 76472-1141 HUMAN OTC DRUG Coffea Cruda 30c ARABICA COFFEE BEAN PELLET SUBLINGUAL 20111124 UNAPPROVED HOMEOPATHIC BrandStorm HBC ARABICA COFFEE BEAN 30 [hp_C]/1 76472-1142_70b33c76-9418-4ff7-ae74-d9774c70a9e6 76472-1142 HUMAN OTC DRUG Gelsemium Sempervirens 30c GELSEMIUM SEMPERVIRENS ROOT PELLET SUBLINGUAL 20111124 UNAPPROVED HOMEOPATHIC BrandStorm HBC GELSEMIUM SEMPERVIRENS ROOT 30 [hp_C]/1 76472-1143_f041aded-17bf-45b5-a140-38f1f118ff3d 76472-1143 HUMAN OTC DRUG Hamamelis Virginiana 30c HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK PELLET SUBLINGUAL 20111124 UNAPPROVED HOMEOPATHIC BrandStorm HBC HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 30 [hp_C]/1 76472-1144_aace12ee-e694-4b5c-abff-e6c03855f9d0 76472-1144 HUMAN OTC DRUG Hepar Sulphuris Calcareum 30c CALCIUM SULFIDE PELLET SUBGINGIVAL 20111124 UNAPPROVED HOMEOPATHIC BrandStorm HBC CALCIUM SULFIDE 30 [hp_C]/1 76472-1145_fda110dc-efcc-4533-bf7f-fdeb1de06500 76472-1145 HUMAN OTC DRUG Histaminum Hydrochloricum HISTAMINE DIHYDROCHLORIDE PELLET SUBLINGUAL 20111201 UNAPPROVED HOMEOPATHIC BrandStorm HBC HISTAMINE DIHYDROCHLORIDE 30 [hp_C]/1 76472-1146_44b64de5-cdb0-43f9-98a5-6ce12d366441 76472-1146 HUMAN OTC DRUG HYDRASTIS CANADENSIS GOLDENSEAL PELLET SUBLINGUAL 20111115 UNAPPROVED HOMEOPATHIC BrandStorm HBC GOLDENSEAL 30 [hp_C]/1 76472-1147_2d5c5f02-5c3c-4363-8676-2defd3190f42 76472-1147 HUMAN OTC DRUG Hypericum Perforatum 30c HYPERICUM PERFORATUM PELLET SUBLINGUAL 20111115 UNAPPROVED HOMEOPATHIC BrandStorm HBC HYPERICUM PERFORATUM 30 [hp_C]/1 76472-1148_4638a39c-4482-44c4-9a63-709798f04477 76472-1148 HUMAN OTC DRUG Ignatia Amara 30c STRYCHNOS IGNATII SEED PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC STRYCHNOS IGNATII SEED 30 [hp_C]/1 76472-1149_e1bfd6b2-5dc2-446a-9c21-312c5700f5aa 76472-1149 HUMAN OTC DRUG Kali Bichromicum 30c POTASSIUM DICHROMATE PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC POTASSIUM DICHROMATE 30 [hp_C]/1 76472-1150_716ebe62-a55b-4bdf-83ab-12ef3f3e920c 76472-1150 HUMAN OTC DRUG Lachesis Mutus LACHESIS MUTA VENOM PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC LACHESIS MUTA VENOM 30 [hp_C]/1 76472-1151_90a1d5d8-8cf1-4584-872d-d0b1bc41aa95 76472-1151 HUMAN OTC DRUG Ledum Palustre 30c LEDUM PALUSTRE TWIG PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC LEDUM PALUSTRE TWIG 30 [hp_C]/1 76472-1152_c6ea8f22-c119-4899-8a1b-0b64c453a616 76472-1152 HUMAN OTC DRUG Lycopodium Clavatum LYCOPODIUM CLAVATUM SPORE PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC LYCOPODIUM CLAVATUM SPORE 30 [hp_C]/1 76472-1153_4000db6a-df7c-417f-839e-d87f7d6f2abf 76472-1153 HUMAN OTC DRUG Mercurius Solubilis MERCURIUS SOLUBILIS PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC MERCURIUS SOLUBILIS 30 [hp_C]/1 76472-1154_a47f5d83-1816-470b-ac9c-760b67fc0c17 76472-1154 HUMAN OTC DRUG Natrum Muriaticum SODIUM CHLORIDE PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC SODIUM CHLORIDE 30 [hp_C]/1 76472-1155_c19295ef-4e46-401c-987e-a8a216912b6f 76472-1155 HUMAN OTC DRUG Nux Vomica STRYCHNOS NUX-VOMICA SEED PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/1 76472-1156_263ae04c-341a-4a75-9a5f-0d8cb6b9e41a 76472-1156 HUMAN OTC DRUG Phosphorus PHOSPHORUS PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC PHOSPHORUS 30 [hp_C]/1 76472-1157_aaf9c500-cb74-4bb7-a45a-733520aca71f 76472-1157 HUMAN OTC DRUG Phytolacca Decandra PHYTOLACCA AMERICANA ROOT PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC PHYTOLACCA AMERICANA ROOT 30 [hp_C]/1 76472-1158_bec5d910-aede-44be-89a6-6abb94ab19ef 76472-1158 HUMAN OTC DRUG Pulsatilla PULSATILLA VULGARIS PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC PULSATILLA VULGARIS 30 [hp_C]/1 76472-1159_31d9e6c4-abbc-40d1-ac1e-af8baa88296b 76472-1159 HUMAN OTC DRUG Rhus Toxicodendron TOXICODENDRON PUBESCENS LEAF PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC TOXICODENDRON PUBESCENS LEAF 30 [hp_C]/1 76472-1160_44807d8b-f144-4b82-a690-21ba5f4a86a5 76472-1160 HUMAN OTC DRUG Ruta Graveolens RUTA GRAVEOLENS FLOWERING TOP PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC RUTA GRAVEOLENS FLOWERING TOP 30 [hp_C]/1 76472-1161_26c90f3e-9851-4301-bf26-c82303f5a26c 76472-1161 HUMAN OTC DRUG Sepia 30c SEPIA OFFICINALIS JUICE PELLET SUBLINGUAL 20111108 UNAPPROVED HOMEOPATHIC BrandStorm HBC SEPIA OFFICINALIS JUICE 30 [hp_C]/1 76472-1162_89a1b77d-6e84-477e-a6c9-52d748594abd 76472-1162 HUMAN OTC DRUG Silicea SILICON DIOXIDE PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC SILICON DIOXIDE 30 [hp_C]/1 76472-1163_d8a7ee13-fb0f-4cd8-afba-dc2b7b1859af 76472-1163 HUMAN OTC DRUG Spongia Tosta SPONGIA OFFICINALIS SKELETON, ROASTED PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC SPONGIA OFFICINALIS SKELETON, ROASTED 30 [hp_C]/1 76472-1164_dbb556ab-f22b-4d47-adc2-5f280a4107ee 76472-1164 HUMAN OTC DRUG Staphysagria DELPHINIUM STAPHISAGRIA SEED PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC DELPHINIUM STAPHISAGRIA SEED 30 [hp_C]/1 76472-1165_86f4525f-fca4-4c8e-a5b5-54f44d942a2c 76472-1165 HUMAN OTC DRUG SULPHUR SULFUR PELLET SUBLINGUAL 20111115 UNAPPROVED HOMEOPATHIC BrandStorm HBC SULFUR 30 [hp_C]/1 76472-1166_c97a7df5-63fb-4c54-a71c-5fb4c4a1222b 76472-1166 HUMAN OTC DRUG Symphytum Officinale COMFREY ROOT PELLET SUBLINGUAL 20111115 UNAPPROVED HOMEOPATHIC BrandStorm HBC COMFREY ROOT 30 [hp_C]/1 76472-1167_35b74c69-c045-4abc-bf5d-bcce9e2b9109 76472-1167 HUMAN OTC DRUG Thuja Occidentalis THUJA OCCIDENTALIS LEAFY TWIG PELLET SUBLINGUAL 20111115 UNAPPROVED HOMEOPATHIC BrandStorm HBC THUJA OCCIDENTALIS LEAFY TWIG 30 [hp_C]/1 76478-001_d1c26bc8-7ca6-4e46-affc-1847bd82e720 76478-001 HUMAN PRESCRIPTION DRUG Betimol Timolol SOLUTION/ DROPS OPHTHALMIC 20140102 NDA NDA020439 Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) (968937719) TIMOLOL 2.56 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 76478-002_d1c26bc8-7ca6-4e46-affc-1847bd82e720 76478-002 HUMAN PRESCRIPTION DRUG Betimol Timolol SOLUTION/ DROPS OPHTHALMIC 20140102 NDA NDA020439 Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) (968937719) TIMOLOL 5.12 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] 76478-289_ab302927-21d6-4916-b750-51bf1592b2c9 76478-289 HUMAN PRESCRIPTION DRUG EMLA lidocaine and prilocaine CREAM TOPICAL 20121112 NDA NDA019941 Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 76478-479_1a428a1c-fcf8-4c4c-a67c-aac5bc5348da 76478-479 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride JELLY TOPICAL 20120701 NDA NDA008816 Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) LIDOCAINE HYDROCHLORIDE .5 mg/18mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] 76478-501_e40293a3-3017-4755-afd1-47541113d4b4 76478-501 HUMAN PRESCRIPTION DRUG Nembutal Sodium pentobarbital sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083246 Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) PENTOBARBITAL SODIUM 50 mg/mL CII 76478-611_a0a8d263-2bcb-4ff7-a8ed-43794f9aeb21 76478-611 HUMAN PRESCRIPTION DRUG Cogentin benztropine mesylate INJECTION INTRAMUSCULAR; INTRAVENOUS 19590805 NDA NDA012015 Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) BENZTROPINE MESYLATE 1 mg/mL Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] 76478-711_aebe3b0a-b212-49cf-ae95-73f6f4be2e7f 76478-711 HUMAN PRESCRIPTION DRUG Sodium Diuril chlorothiazide sodium INJECTION INTRAVENOUS 19581003 NDA NDA011145 Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) CHLOROTHIAZIDE SODIUM .5 mg/18mL Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] 76479-4403_f33bb874-d16e-4926-b066-a323b9b3c161 76479-4403 HUMAN OTC DRUG Eco.kid PIPERONYL BUTOXIDE SHAMPOO TOPICAL 20111001 OTC MONOGRAPH FINAL part358G Fravin Pty Ltd PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 2; .17 mL/100mL; mL/100mL 76482-013_2deddc27-52fd-4021-bb95-36862e4dfc22 76482-013 HUMAN OTC DRUG LEudine Anti-dandruff Pyrithione Zinc SHAMPOO TOPICAL 20130401 OTC MONOGRAPH FINAL part358H B&R Products Inc PYRITHIONE ZINC 1 g/100mL 76484-948_55480e63-4b5c-4230-905b-5edfc1f7bb18 76484-948 HUMAN OTC DRUG 20/20 Topical Anesthetic BENZOCAINE STRIP DENTAL 20120228 OTC MONOGRAPH FINAL part356 Advanced Dental Anesthetics BENZOCAINE 10 mg/1 76485-1000_6ad836e5-3e2c-4f88-a3c7-1b704fdd6991 76485-1000 HUMAN OTC DRUG Moisture Renew Coral Shimmer (120) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1001_49ca4d03-ed54-4488-a1f8-34ee4e6f01e1 76485-1001 HUMAN OTC DRUG Moisture Renew Dreamy (140) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1002_c672f55a-9ecf-4ae9-af6a-1a437e6aeca7 76485-1002 HUMAN OTC DRUG Moisture Renew Pink Chic (220) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1003_c2a12fbc-9cc1-490f-b6ea-ab48dd3de2fd 76485-1003 HUMAN OTC DRUG Moisture Renew Pink Star (235) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1004_0d37a18a-520a-41cc-9d62-d7445daa0446 76485-1004 HUMAN OTC DRUG Moisture Renew Latino (240) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1005_c71c5065-3f28-4aad-a931-2b528ad4fe96 76485-1005 HUMAN OTC DRUG Moisture Renew Rose Blush (300) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1007_5cbeb24a-6012-4849-a62b-48c7999b2537 76485-1007 HUMAN OTC DRUG Moisture Renew Rose Shimmer (370) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1008_d7adcc9c-e1f1-4655-b618-8d77994a6154 76485-1008 HUMAN OTC DRUG Moisture Renew Vintage Pink (380) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1009_af10ab70-9d05-4f09-ab93-f8a7eafbd887 76485-1009 HUMAN OTC DRUG Moisture Renew Crystal Mauve (420) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1010_22312a94-eb3e-4091-98b7-e0c3584738db 76485-1010 HUMAN OTC DRUG Moisture Renew Mauve Pink (460) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1011_4515e12d-499c-439d-b22c-41936c27c02e 76485-1011 HUMAN OTC DRUG Moisture Renew Berry Rose (500) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1012_2eb02ce7-f1b3-44cd-ac7d-fa0e75696b29 76485-1012 HUMAN OTC DRUG Moisture Renew Violet Pop (520) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1013_0fd04a18-572e-40fb-a049-c7d8d6fdda57 76485-1013 HUMAN OTC DRUG Moisture Renew Burgundy Lustre (540) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1014_7d9a0153-7af9-4330-9e06-bef9618caac2 76485-1014 HUMAN OTC DRUG Moisture Renew Summer Angel (640) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1015_356fff2a-bc73-4a7e-b934-d5b1d58cd11a 76485-1015 HUMAN OTC DRUG Moisture Renew Nude Delight (642) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1016_9e7d2948-6a86-43fd-bce6-f62bd84040a1 76485-1016 HUMAN OTC DRUG Moisture Renew Dusty Rose (645) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1017_2392d607-fb9a-4980-bcf8-0ed7b66cb7b1 76485-1017 HUMAN OTC DRUG Moisture Renew Precious Brown (680) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1018_fcb84a41-1e1d-436b-92a8-63d8f78d20c6 76485-1018 HUMAN OTC DRUG Moisture Renew Iced Coffee (700) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1019_0bc82e46-2c87-4992-9b57-432100d4c51a 76485-1019 HUMAN OTC DRUG Moisture Renew Auburn Breeze (740) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1020_edf37953-6ed1-4705-b023-7d0508878330 76485-1020 HUMAN OTC DRUG Moisture Renew Cherrylicious (820) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1021_98443dfc-4f10-456f-86f8-062dfa60b0fe 76485-1021 HUMAN OTC DRUG Moisture Renew Burgundy Shine (840) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1022_29588ca6-3c9a-47ac-bf9b-c58888a02a7e 76485-1022 HUMAN OTC DRUG Moisture Renew Rouge (850) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1023_612d1a0d-66e6-4a64-95f1-0fa44901510e 76485-1023 HUMAN OTC DRUG Moisture Renew Red Alert (900) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g 76485-1024_0454a7fe-f85d-4ec5-a389-5359436537d9 76485-1024 HUMAN OTC DRUG Rimmel BB Beauty Balm Light Avobenzone, Octinoxate, Octisalate and Octocrylene LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .9; 1.2; 1.2; .6 mL/30mL; mL/30mL; mL/30mL; mL/30mL 76485-1025_f4414210-3dae-4be5-819d-bf7e50fb26a8 76485-1025 HUMAN OTC DRUG Rimmel BB Beauty Balm Medium Avobenzone, Octinoxate, Octisalate and Octocrylene LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .9; 1.2; 1.2; .6 mL/30mL; mL/30mL; mL/30mL; mL/30mL 76485-1026_e8275f1d-9373-4c7a-899e-ea0df170b96d 76485-1026 HUMAN OTC DRUG Rimmel BB Beauty Balm Medium Dark Avobenzone, Octinoxate, Octisalate and Octocrylene LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .9; 1.2; 1.2; .6 mL/30mL; mL/30mL; mL/30mL; mL/30mL 76485-1027_db4ffd79-a6a8-4458-ac1b-8736d2f795fe 76485-1027 HUMAN OTC DRUG Match Perfection SPF 18 Classic Ivory 101 Octinoxate Titanium Dioxide LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.2; 1.5 mL/30mL; mL/30mL 76485-1028_4f72c004-b2b9-4cf0-9156-f5f91c33ee18 76485-1028 HUMAN OTC DRUG Match Perfection SPF 18 Light Nude 102 Octinoxate Titanium Dioxide LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.2; 1.5 mL/30mL; mL/30mL 76485-1029_8f129af1-dde9-4b94-8a70-f544b4f4983e 76485-1029 HUMAN OTC DRUG Match Perfection SPF 18 Ivory 120 Octinoxate and Titanium Dioxide LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.2; 1.5 mL/30mL; mL/30mL 76485-1030_90c712dd-72a4-497f-87ed-4e1a798bfd18 76485-1030 HUMAN OTC DRUG Match Perfection SPF 18 True Ivory 130 Octinoxate Titanium Dioxide LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.2; 1.5 mL/30mL; mL/30mL 76485-1031_0772dedd-cc81-4760-9a10-95cb7205cafa 76485-1031 HUMAN OTC DRUG Match Perfection SPF 18 Nude 202 Octinoxate Titanium Dioxide LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.2; 1.5 mL/30mL; mL/30mL 76485-1032_6c7b91dc-9751-41d7-8165-fa597dbc1b29 76485-1032 HUMAN OTC DRUG Match Perfection SPF 18 Soft Beige 240 Octinoxate Titanium Dioxide LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.2; 1.5 mL/30mL; mL/30mL 76485-1033_7a02b4e8-608e-4f5e-b86b-40341e0989f7 76485-1033 HUMAN OTC DRUG Match Perfection SPF 18 Classic Beige 250 Octinoxate and Titanium Dioxide LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.2; 1.5 mL/30mL; mL/30mL 76485-1034_b46c4c51-0fce-4aa7-97fe-d5f38eb9b870 76485-1034 HUMAN OTC DRUG Match Perfection SPF 18 Sand 330 Octinoxate Titanium Dioxide LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.2; 1.5 mL/30mL; mL/30mL 76485-1035_54439149-ec52-44c5-b2ce-d87c25311e41 76485-1035 HUMAN OTC DRUG Long Lasting Finish with Comfort Serum SPF 20 Light Ivory Titanium Dioxide, Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE .8325; 2.9574 g/301mL; g/301mL 76485-1036_ec8597fa-3641-4520-b88e-2aad855e2a9f 76485-1036 HUMAN OTC DRUG Long Lasting Finish with Comfort Serum SPF 20 Ivory Titanium Dioxide, Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE .8325; 2.9574 g/301mL; g/301mL 76485-1037_a02d12ac-68d6-429b-92aa-2cd2ed60d0b8 76485-1037 HUMAN OTC DRUG Long Lasting Finish with Comfort Serum SPF 20 Classic Ivory Titanium Dioxide, Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE .8325; 2.9574 g/301mL; g/301mL 76485-1038_ca5f29a1-06c0-417d-8b89-06db1a7ea7c4 76485-1038 HUMAN OTC DRUG Long Lasting Finish with Comfort Serum SPF 20 Soft Beige Titanium Dioxide, Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE .8325; 2.9574 g/301mL; g/301mL 76485-1039_71b3200d-5ce0-4cd4-a014-5ff6fdd92913 76485-1039 HUMAN OTC DRUG Long Lasting Finish with Comfort Serum SPF 20 Classic Beige Titanium Dioxide, Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE .8325; 2.9574 g/301mL; g/301mL 76485-1040_2428a126-dbba-4396-b7d7-29d4b06f9a5d 76485-1040 HUMAN OTC DRUG Long Lasting Finish with Comfort Serum SPF 20 True Beige Titanium Dioxide, Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE .8325; 2.9574 g/301mL; g/301mL 76485-1041_31d64730-5e73-4e86-a192-ebc7753ef8f8 76485-1041 HUMAN OTC DRUG Long Lasting Finish with Comfort Serum SPF 20 Sand Titanium Dioxide, Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE .8325; 2.9574 g/301mL; g/301mL 76485-1042_284151c0-52f4-4130-8905-fa9f0f3de865 76485-1042 HUMAN OTC DRUG Rimmel BB Cream Beauty Balm Radiance SPF 20 Light Avobenzone, Octinoxate, Octisalate, Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 1.008; 1.008; 1.344; 1.008 g/30mL; g/30mL; g/30mL; 1/30mL 76485-1043_ab393b15-c976-4769-9cc1-2e9849474594 76485-1043 HUMAN OTC DRUG Rimmel BB Cream Beauty Balm Radiance SPF 20 Medium Avobenzone, Octinoxate, Octisalate, Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 1.008; 1.008; 1.344; 1.008 g/30mL; g/30mL; g/30mL; 1/30mL 76485-1044_09f334bc-894b-4a52-88d9-62a9545909d1 76485-1044 HUMAN OTC DRUG Rimmel BB Cream Matte 9-IN-1 Skin Perfecting Super Makeup SPF 15 Light Octinoxate, Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTOCRYLENE 2.3; .3 g/30mL; g/30mL 76485-1045_43060345-d87f-4002-bc49-0b5697e4cec9 76485-1045 HUMAN OTC DRUG Rimmel BB Cream Matte 9-IN-1 Skin Perfecting Super Makeup SPF 15 Light Octinoxate, Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTOCRYLENE 2.3; .3 g/30mL; g/30mL 76485-1046_599b2097-6df7-44e0-8b2d-130c093e25fc 76485-1046 HUMAN OTC DRUG Rimmel BB Cream Matte 9-IN-1 Skin Perfecting Super Makeup SPF 15 Medium Dark Octinoxate, Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTOCRYLENE 2.3; .3 g/30mL; g/30mL 76485-1047_8d11a6dd-290d-436a-9a1e-b167176a2ad9 76485-1047 HUMAN OTC DRUG Rimmel BB Cream Matte 9-IN-1 Skin Perfecting Super Makeup SPF 15 Light Medium Octinoxate, Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTOCRYLENE 2.3; .3 g/30mL; g/30mL 76485-1048_06d75389-4f47-4ab0-9320-53eba6cceb46 76485-1048 HUMAN OTC DRUG Rimmel BB Cream 9-IN-1 Skin Perfecting Super Makeup Light Medium Avobenzone, Octinoxate, Octisalate, Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .9; 1.3; 1.3; .6 g/30mL; g/30mL; g/30mL; 1/30mL 76489-001_a2ac1115-42a8-11e1-b86c-0800200c9a66 76489-001 CELLULAR THERAPY HemaCord HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL INJECTION INTRAVENOUS 20111110 BLA BLA125397 New York Blood Center HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL 500000000 1/25mL Allogeneic Cord Blood Hematopoietic Progenitor Cell Therapy [EPC],Hematopoietic Stem Cells [Chemical/Ingredient],Cells, Allogeneic [Chemical/Ingredient] 76490-0010_df50bade-c0e2-4958-9d19-1db4ddac7e4c 76490-0010 HUMAN OTC DRUG Hevert Stress Relief BLACK COHOSH, ANAMIRTA COCCULUS SEED, CYPRIPEDIUM PARVIFOLUM ROOT, STRYCHNOS IGNATII SEED, LILIUM LANCIFOLIUM FLOWERING TOP, PASSIFLORA INCARNATA FLOWERING TOP, PLATINUM, VALERIAN, and ZINC VALERATE DIHYDRATE TABLET ORAL 20111115 20151231 UNAPPROVED HOMEOPATHIC EuroHom LLC ANAMIRTA COCCULUS SEED; BLACK COHOSH; CYPRIPEDIUM PARVIFOLUM ROOT; LILIUM LANCIFOLIUM WHOLE FLOWERING; PASSIFLORA INCARNATA FLOWERING TOP; PLATINUM; STRYCHNOS IGNATII SEED; VALERIAN; ZINC VALERATE DIHYDRATE 6; 4; 6; 6; 3; 8; 6; 2; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 76490-0011_d0199faf-58f7-4032-ad75-10c7265f876d 76490-0011 HUMAN OTC DRUG Hevert Sinus Relief APIS MELLIFERA, BAPTISIA TINCTORIA, ECHINACEA, UNSPECIFIED, CALCIUM SULFIDE, POTASSIUM DICHROMATE, LACHESIS MUTA VENOM, LUFFA OPERCULATA FRUIT, SILICON DIOXIDE, and SPONGIA OFFICINALIS SKELETON, ROASTED TABLET ORAL 20111115 UNAPPROVED HOMEOPATHIC EuroHom LLC APIS MELLIFERA; BAPTISIA TINCTORIA; CALCIUM SULFIDE; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; LUFFA OPERCULATA FRUIT; POTASSIUM DICHROMATE; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED 4; 4; 4; 2; 8; 6; 8; 2; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 76499-002_2f1bcc70-8bbc-4b60-847b-4c6f22470bbf 76499-002 HUMAN OTC DRUG Shaving Factory Disposable Styptic Pencil ALUMINUM SULFATE STICK TOPICAL 20120101 OTC MONOGRAPH FINAL part347 Derby International LLC ALUMINUM SULFATE 9 mL/10mL 76509-001_85541720-1282-4fd8-ba80-6e93fc7a2741 76509-001 HUMAN OTC DRUG MAXRELIEF ARNICA MONTANA FLOWER SPRAY TOPICAL 20120101 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd ARNICA MONTANA FLOWER; EUCALYPTUS OIL; ROSEMARY OIL 50; 6; 110 mg/120mL; mg/120mL; mg/120mL 76509-050_895a085e-3ec5-47f2-a8ba-90081566a7a9 76509-050 HUMAN OTC DRUG Kids Travel Sickness Cocculus 30C, Nux Vomica 30C, Borax 6C LOZENGE ORAL 20140211 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA JATEORHIZA CALUMBA ROOT; SODIUM BORATE; STRYCHNOS NUX-VOMICA SEED 30; 6; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 76509-100_64217008-f13d-4ad5-8ec0-1b815a18876f 76509-100 HUMAN OTC DRUG kids throat Aconite 30C, Belladonna 30C, Chamomilla 30C, Phytolacca 30C LOZENGE ORAL 20140212 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA ACONITUM NAPELLUS; BELLADONNA LEAF; MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 76509-150_289aaee7-1d88-4140-aa3a-90ce1ee74e28 76509-150 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C LOZENGE ORAL 20140212 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA ATROPA BELLADONNA; DROSERA INTERMEDIA; IPECAC; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS WHOLE 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 76509-151_24047d42-b37a-4a8f-bac3-02a39276a9c4 76509-151 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA ATROPA BELLADONNA; DROSERA INTERMEDIA; IPECAC; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS WHOLE 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 76509-152_2c9aa74d-941f-4035-8b35-73e11f8f909d 76509-152 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA ATROPA BELLADONNA; DROSERA INTERMEDIA; IPECAC; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS WHOLE 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 76509-180_4ff88769-7699-42c4-ac40-86fc9c6b441e 76509-180 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA ATROPA BELLADONNA; DROSERA INTERMEDIA; IPECAC; PHOSPHORUS; POTASSIUM CARBONATE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS WHOLE 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 76509-200_620ee495-da43-45d4-8b51-f06c588e1581 76509-200 HUMAN OTC DRUG kids cold Allium Cepa 30C, Kali Bichromium 30C, Kali Sulphuricum 30C, Nux Vomica 30C, Natrum Muriaticum 30C, Pulsatilla 30C, Silicea 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA ONION; POTASSIUM DICHROMATE; POTASSIUM SULFATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 76509-400_2947edb5-cf6e-4472-8d3c-84a73495e7da 76509-400 HUMAN OTC DRUG kids cough cold and throat Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C KIT 20140430 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA 76509-700_4d499417-f4fb-47f9-b75e-3ac7e1b416d6 76509-700 HUMAN OTC DRUG MaxRelief Arnica camphor CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part348 Natures Investment Holdings Pty Ltd dba Maxrelief USA CAMPHOR (NATURAL) 30 mg/1000mg 76509-800_676d83c7-ffe3-4d9d-8d57-182de5980c08 76509-800 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipecacuhuana 30C, Pulsatilla 30C, Belladonna 30C KIT 20140430 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA 76518-100_28931b86-a3a1-42b5-a2df-45be00c37de3 76518-100 HUMAN OTC DRUG Sennazon Sennosides A and B SYRUP ORAL 20120501 OTC MONOGRAPH NOT FINAL part334 Bayshore Pharmaceuticals LLC [FL] SENNOSIDES A AND B 8.8 mg/5mL 76519-1000_1987e93d-951f-4738-af92-6196f753d121 76519-1000 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20110829 ANDA ANDA078722 H.J. Harkins Company, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] 76519-1001_989e7994-d299-4a68-ae22-259fd0290a3e 76519-1001 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20111122 ANDA ANDA076361 H.J. Harkins Company, Inc. LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] 76519-1003_c92ab250-669c-4b29-945f-c6320a6a4edc 76519-1003 HUMAN OTC DRUG DOK EXTRA STRENGTH STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20020827 OTC MONOGRAPH NOT FINAL part334 H.J. Harkins Company, Inc. DOCUSATE SODIUM 250 mg/1 76519-1004_25eeeb36-7337-49e8-a1ef-731e8afcca43 76519-1004 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20070816 ANDA ANDA078425 H.J. Harkins Company, Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] 76519-1005_dae1ab04-6614-4083-b7b6-2612c4be0fe2 76519-1005 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20111227 ANDA ANDA079081 H.J. Harkins Company, Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] 76519-1007_4c109ffc-d99f-4beb-bc0a-4e340b56396c 76519-1007 HUMAN PRESCRIPTION DRUG Nystatin Nystatin POWDER TOPICAL 20090915 ANDA ANDA065203 H.J. Harkins Company, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] 76519-1009_f16375f3-737f-41b8-a412-6962874bd080 76519-1009 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120314 NDA NDA022370 H.J. Harkins Company, Inc. TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] 76519-1011_f83eee6e-4593-47b2-b948-d06a31eab363 76519-1011 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen HYDROCODONE BITARTRATE, ACETAMINOPHEN TABLET ORAL 20120517 ANDA ANDA040846 H.J. Harkins Company, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 2.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII 76519-1017_70ee2244-de89-4c89-8a23-b23d2843f281 76519-1017 HUMAN PRESCRIPTION DRUG Sprix ketorolac tromethamine SPRAY, METERED NASAL 20110426 NDA NDA022382 H.J. Harkins Company, Inc. KETOROLAC TROMETHAMINE 15.75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] 79596-090_91a8f2e4-648e-4fd7-8ca9-7f77183882ea 79596-090 HUMAN OTC DRUG Too Faced Tinted Beauty Balm SPF-20 TITANIUM DIOXIDE ZINC OXIDE CREAM TOPICAL 20121214 OTC MONOGRAPH FINAL part352 TOO FACED COSMETICS TITANIUM DIOXIDE; ZINC OXIDE 5; 5 g/100mL; g/100mL 79596-096_5061cfdc-3dc4-4c21-a23a-3c1e6a2afd0e 79596-096 HUMAN OTC DRUG Too Faced BB Creme Complete Coverage Make-Up SPF-20 SNOW GLOW TITANIUM DIOXIDE CREAM TOPICAL 20121214 OTC MONOGRAPH FINAL part352 TOO FACED COSMETICS TITANIUM DIOXIDE 8.3 g/100g 79596-097_db32e599-9e5d-4467-8aba-62ea222e12c3 79596-097 HUMAN OTC DRUG Too Faced BB Creme Complete Coverage Make-Up SPF-20 VANILLA GLOW TITANIUM DIOXIDE CREAM TOPICAL 20121214 OTC MONOGRAPH FINAL part352 TOO FACED COSMETICS TITANIUM DIOXIDE 8.3 g/100g 79596-098_365d74d4-7172-4478-98b9-8e2553222ca1 79596-098 HUMAN OTC DRUG Too Faced BB Creme Complete Coverage Make-Up SPF-20 CREAM GLOW TITANIUM DIOXIDE CREAM TOPICAL 20121214 OTC MONOGRAPH FINAL part352 TOO FACED COSMETICS TITANIUM DIOXIDE 8.3 g/100g 79596-099_dc0a1453-3c55-494b-a1bf-63bf913cfc65 79596-099 HUMAN OTC DRUG Too Faced BB Creme Complete Coverage Make-Up SPF-20 LINEN GLOW TITANIUM DIOXIDE CREAM TOPICAL 20121214 OTC MONOGRAPH FINAL part352 TOO FACED COSMETICS TITANIUM DIOXIDE 8.3 g/100g 79596-100_2bc77006-026f-49f3-a738-6461eaf35841 79596-100 HUMAN OTC DRUG Too Faced BB Creme Complete Coverage Make-Up SPF-20 NUDE GLOW TITANIUM DIOXIDE CREAM TOPICAL 20121214 OTC MONOGRAPH FINAL part352 TOO FACED COSMETICS TITANIUM DIOXIDE 8.3 g/100g 8290-3268_34ae7fdd-28e6-41f2-86a9-54f5eb60388c 8290-3268 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 19931001 OTC MONOGRAPH NOT FINAL part333A Becton Dickinson and Company ISOPROPYL ALCOHOL .75 g/1 86227-000_4bab2f34-5966-4fb5-a081-bec2a811b314 86227-000 HUMAN OTC DRUG Sure Comfort Alcohol Prep Pads ISOPROPYL ALCOHOL LIQUID TOPICAL 20131204 OTC MONOGRAPH NOT FINAL part333A Allison Medical Inc. ISOPROPYL ALCOHOL 70 g/100g 8880-9505_1394ceab-ed35-41fe-8ceb-bd2a83912d0f 8880-9505 HUMAN PRESCRIPTION DRUG Thermazene Silver Sulfadiazine CREAM TOPICAL 20120820 NDA NDA018810 COVIDIEN INC. SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] 89156-000_77605a16-00c4-4108-a207-67cbb01f5bdb 89156-000 HUMAN OTC DRUG Global EASY PREP alcohol prep pads ISOPROPYL ALCOHOL LIQUID TOPICAL 20140319 OTC MONOGRAPH NOT FINAL part333A Global Diabetic Distributors ISOPROPYL ALCOHOL 70 g/100g 89474-100_074ad390-ab24-0e7a-e054-00144ff88e88 89474-100 HUMAN OTC DRUG CareFine Alcohol Swabs 100 ct Isopropyl Alcohol Swab SWAB TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A Facet Technologies ISOPROPYL ALCOHOL 70 mL/100mL 89474-102_074c7751-c3a7-3ab6-e054-00144ff8d46c 89474-102 HUMAN OTC DRUG CareFine Alcohol Swabs 200 Ct Isopropyl Alcohol Swab SWAB TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A Facet Technologies ISOPROPYL ALCOHOL 70 mL/100mL 98132-121_f6ca65be-cdef-4f41-a842-0925ad450bb7 98132-121 HUMAN OTC DRUG Deep Bisque Original Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100105 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 16; 10 g/100g; g/100g 98132-122_46ef8e6f-96f3-441e-a4ef-dc3a6d5f863e 98132-122 HUMAN OTC DRUG bareMinerals Natural Sunscreen Light Titanium Dioxide POWDER TOPICAL 20090131 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 12 g/100g 98132-123_d9c5bb8f-e1e7-4b4a-89db-78c1f34454b5 98132-123 HUMAN OTC DRUG BareMinerals Natural Sunscreen Medium Titanium Dioxide POWDER TOPICAL 20090131 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 12 g/100g 98132-124_8a86b900-d14d-4842-842d-2a631f14c38a 98132-124 HUMAN OTC DRUG Natural Sunscreen Tan Titanium Dioxide POWDER TOPICAL 20090131 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 12 g/100g 98132-128_2421e199-7229-46a7-b3b5-4a669006dba0 98132-128 HUMAN OTC DRUG BareMinerals Fair Matte Fair Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-129_2421e199-7229-46a7-b3b5-4a669006dba0 98132-129 HUMAN OTC DRUG BareMinerals Light Matte Light Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-130_2421e199-7229-46a7-b3b5-4a669006dba0 98132-130 HUMAN OTC DRUG BareMinerals Fairly Light matte Fairly Light Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-131_2421e199-7229-46a7-b3b5-4a669006dba0 98132-131 HUMAN OTC DRUG BareMinerals Medium Beige matte Medium Beige Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-132_2421e199-7229-46a7-b3b5-4a669006dba0 98132-132 HUMAN OTC DRUG BareMinerals Medium Matte Medium Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-133_2421e199-7229-46a7-b3b5-4a669006dba0 98132-133 HUMAN OTC DRUG BareMinerals Medium Tan matte Medium Tan Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-134_2421e199-7229-46a7-b3b5-4a669006dba0 98132-134 HUMAN OTC DRUG BareMinerals Golden Medium matte Golden Medium Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-135_2421e199-7229-46a7-b3b5-4a669006dba0 98132-135 HUMAN OTC DRUG BareMinerals Warm Tan Warm Tan Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-136_2421e199-7229-46a7-b3b5-4a669006dba0 98132-136 HUMAN OTC DRUG BareMinerals Tan Matte Tan Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-137_2421e199-7229-46a7-b3b5-4a669006dba0 98132-137 HUMAN OTC DRUG BareMinerals Dark Matte Dark Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-138_2421e199-7229-46a7-b3b5-4a669006dba0 98132-138 HUMAN OTC DRUG BareMinerals Golden Deep matte Golden Deep Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-139_2421e199-7229-46a7-b3b5-4a669006dba0 98132-139 HUMAN OTC DRUG BareMinerals Medium Deep matte Medium Deep Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-140_2421e199-7229-46a7-b3b5-4a669006dba0 98132-140 HUMAN OTC DRUG BareMinerals Deepest Deep matte Deepest Deep Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-141_2421e199-7229-46a7-b3b5-4a669006dba0 98132-141 HUMAN OTC DRUG BareMinerals Golden Dark matte Golden Dark Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-142_2421e199-7229-46a7-b3b5-4a669006dba0 98132-142 HUMAN OTC DRUG BareMinerals Medium Dark matte Medium Dark Matte Titanium Dioxide and Zinc Oxide POULTICE TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-147_cdafa965-da3d-4ab2-a1c0-6e95ee138512 98132-147 HUMAN OTC DRUG Golden Tan Original Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100105 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11.7; 20 g/100g; g/100g 98132-148_84629839-2271-430a-a37f-e7b6e06f5c44 98132-148 HUMAN OTC DRUG Warm Dark Original Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100105 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 20 g/100g; g/100g 98132-149_22c8402f-b073-47c9-87a6-c7e978f78539 98132-149 HUMAN OTC DRUG Warm Deep Original Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100105 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 20 g/100g; g/100g 98132-151_a61583dc-9515-42a5-94a4-70c42e61378e 98132-151 HUMAN OTC DRUG bareMinerals Golden Fair Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-152_a61583dc-9515-42a5-94a4-70c42e61378e 98132-152 HUMAN OTC DRUG bareMinerals Fairly Medium Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-153_2421e199-7229-46a7-b3b5-4a669006dba0 98132-153 HUMAN OTC DRUG BareMinerals Golden Tan matte Golden Tan Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-154_a61583dc-9515-42a5-94a4-70c42e61378e 98132-154 HUMAN OTC DRUG bareMinerals Warm Dark Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-155_a61583dc-9515-42a5-94a4-70c42e61378e 98132-155 HUMAN OTC DRUG bareMinerals Medium Beige Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-156_3bba3e6a-2928-4f50-8535-7ef85d2a1880 98132-156 HUMAN OTC DRUG Warm Deep Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100105 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-158_4dea5c89-c41a-47ed-a8bd-76a8ca83983a 98132-158 HUMAN OTC DRUG BareMinerals Faux Tan Faux Tan Titanium Dioxide POWDER TOPICAL 20110105 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 25 g/100g 98132-159_d06886ac-6218-48c3-a2b5-b08f055dc444 98132-159 HUMAN OTC DRUG BareMinerals Mineral Veil Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090730 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 25; 10 g/100g; g/100g 98132-160_d06886ac-6218-48c3-a2b5-b08f055dc444 98132-160 HUMAN OTC DRUG BareMinerals Tinted Mineral Veil Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090730 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 25; 10 g/100g; g/100g 98132-161_e393dbba-bc6a-463f-bb3e-3afc30d6b2c5 98132-161 HUMAN OTC DRUG BareMinerals Bronzing Mineral Veil Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20110105 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 25; 10 g/100g; g/100g 98132-162_7b4cf4ec-8db5-4db6-91a2-4dea25f70457 98132-162 HUMAN OTC DRUG bareMinerals Well-rested Titanium Dioxide POWDER TOPICAL 20110105 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 20 g/100g 98132-163_11552850-abf2-40ca-9530-627246a3b27e 98132-163 HUMAN OTC DRUG Ready Foundation Fair Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-164_11552850-abf2-40ca-9530-627246a3b27e 98132-164 HUMAN OTC DRUG Ready Foundation Fairly Light Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-165_11552850-abf2-40ca-9530-627246a3b27e 98132-165 HUMAN OTC DRUG Ready Foundation Golden Fair Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-166_11552850-abf2-40ca-9530-627246a3b27e 98132-166 HUMAN OTC DRUG Ready Foundation Light Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-167_11552850-abf2-40ca-9530-627246a3b27e 98132-167 HUMAN OTC DRUG Ready Foundation Fairly Medium Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-168_11552850-abf2-40ca-9530-627246a3b27e 98132-168 HUMAN OTC DRUG Ready Foundation Medium Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-169_11552850-abf2-40ca-9530-627246a3b27e 98132-169 HUMAN OTC DRUG Ready Foundation Medium Beige Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-170_11552850-abf2-40ca-9530-627246a3b27e 98132-170 HUMAN OTC DRUG Ready Foundation Golden Medium Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-171_11552850-abf2-40ca-9530-627246a3b27e 98132-171 HUMAN OTC DRUG Ready Foundation Medium Tan Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-172_11552850-abf2-40ca-9530-627246a3b27e 98132-172 HUMAN OTC DRUG Ready Foundation Tan Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-173_11552850-abf2-40ca-9530-627246a3b27e 98132-173 HUMAN OTC DRUG Ready Foundation Warm Tan Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-174_11552850-abf2-40ca-9530-627246a3b27e 98132-174 HUMAN OTC DRUG Ready Foundation Golden Tan Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-175_11552850-abf2-40ca-9530-627246a3b27e 98132-175 HUMAN OTC DRUG Ready Foundation Dark Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-176_11552850-abf2-40ca-9530-627246a3b27e 98132-176 HUMAN OTC DRUG Ready Foundation Medium Dark Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-177_11552850-abf2-40ca-9530-627246a3b27e 98132-177 HUMAN OTC DRUG Ready Foundation Warm Dark Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-178_11552850-abf2-40ca-9530-627246a3b27e 98132-178 HUMAN OTC DRUG Ready Foundation Golden Dark Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-179_11552850-abf2-40ca-9530-627246a3b27e 98132-179 HUMAN OTC DRUG Ready Foundation Medium Deep Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-180_11552850-abf2-40ca-9530-627246a3b27e 98132-180 HUMAN OTC DRUG Ready Foundation Deepest Deep Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-181_11552850-abf2-40ca-9530-627246a3b27e 98132-181 HUMAN OTC DRUG Ready Foundation Golden Deep Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-182_11552850-abf2-40ca-9530-627246a3b27e 98132-182 HUMAN OTC DRUG Ready Foundation Warm Deep Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g 98132-184_13e5d3d9-928d-4e92-a382-7e084f48f85c 98132-184 HUMAN OTC DRUG Antioxidant Primer Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20130331 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 26; 62 mg/mL; mg/mL 98132-186_7797d4f9-33ac-4327-bd21-479ecf67ea43 98132-186 HUMAN OTC DRUG Pure Transformation Sheer Fair Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 18; 5 g/100g; g/100g 98132-187_5a51c4b8-6823-4813-9a24-05e9c2289cf5 98132-187 HUMAN OTC DRUG Pure Transformation Sheer Light Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-188_5a51c4b8-6823-4813-9a24-05e9c2289cf5 98132-188 HUMAN OTC DRUG Pure Transformation Sheer Medium Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-189_7797d4f9-33ac-4327-bd21-479ecf67ea43 98132-189 HUMAN OTC DRUG Pure Transformation Sheer Tan Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 18; 5 g/100g; g/100g 98132-190_d9974e93-5303-4639-b933-5c438d49dc2f 98132-190 HUMAN OTC DRUG Pure Transformation Sheer Clear Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 19; 5 g/100g; g/100g 98132-191_5a51c4b8-6823-4813-9a24-05e9c2289cf5 98132-191 HUMAN OTC DRUG Pure Transformation Sheer Dark Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g 98132-2131_6e877759-8ddb-49d8-be13-25eb21229299 98132-2131 HUMAN OTC DRUG bareMinerals Ready SPF 15 Touch Up Veil Titanium Dioxide POWDER TOPICAL 20110820 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 1.2 g/10g 98132-2132_6e877759-8ddb-49d8-be13-25eb21229299 98132-2132 HUMAN OTC DRUG bareMinerals Ready SPF 15 Touch Up Veil Titanium Dioxide POWDER TOPICAL 20110820 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 1.2 g/10g 98132-300_e4641aaf-fdfd-4ba7-888c-1ef8edaee397 98132-300 HUMAN OTC DRUG bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Translucent Titanium Dioxide and Zinc oxide POWDER TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 1470; 100 mg/10g; mg/10g 98132-301_e4641aaf-fdfd-4ba7-888c-1ef8edaee397 98132-301 HUMAN OTC DRUG bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Tan Titanium Dioxide and Zinc oxide POWDER TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 1470; 100 mg/10g; mg/10g 98132-302_e4641aaf-fdfd-4ba7-888c-1ef8edaee397 98132-302 HUMAN OTC DRUG bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Light Titanium Dioxide and Zinc oxide POWDER TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 1470; 100 mg/10g; mg/10g 98132-303_e4641aaf-fdfd-4ba7-888c-1ef8edaee397 98132-303 HUMAN OTC DRUG bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Medium Titanium Dioxide and Zinc oxide POWDER TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 1470; 100 mg/10g; mg/10g 98132-304_e4641aaf-fdfd-4ba7-888c-1ef8edaee397 98132-304 HUMAN OTC DRUG bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Dark Titanium Dioxide and Zinc oxide POWDER TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 1470; 100 mg/10g; mg/10g 98132-305_e4641aaf-fdfd-4ba7-888c-1ef8edaee397 98132-305 HUMAN OTC DRUG bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Deep Titanium Dioxide and Zinc oxide POWDER TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 1470; 100 mg/10g; mg/10g 98132-664_782d8e17-e356-4504-b328-ef58861e42cf 98132-664 HUMAN OTC DRUG BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE .3 g/2g 98132-665_782d8e17-e356-4504-b328-ef58861e42cf 98132-665 HUMAN OTC DRUG BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE .3 g/2g 98132-666_782d8e17-e356-4504-b328-ef58861e42cf 98132-666 HUMAN OTC DRUG BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE .3 g/2g 98132-667_782d8e17-e356-4504-b328-ef58861e42cf 98132-667 HUMAN OTC DRUG BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE .3 g/2g 98132-668_782d8e17-e356-4504-b328-ef58861e42cf 98132-668 HUMAN OTC DRUG BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE .3 g/2g 98132-669_782d8e17-e356-4504-b328-ef58861e42cf 98132-669 HUMAN OTC DRUG BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE .3 g/2g 98132-670_782d8e17-e356-4504-b328-ef58861e42cf 98132-670 HUMAN OTC DRUG BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE .3 g/2g 98132-671_782d8e17-e356-4504-b328-ef58861e42cf 98132-671 HUMAN OTC DRUG BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE .3 g/2g 98132-700_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-700 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Candlelit Peach Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL 98132-701_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-701 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Radiant Sand Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL 98132-702_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-702 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Soft Shell Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL 98132-703_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-703 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Elegant Taupe Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL 98132-704_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-704 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Soft Linen Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL 98132-705_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-705 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Sweet Spice Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL 98132-706_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-706 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Delicate Moss Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL 98132-707_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-707 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Barely Nude Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL 98132-708_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-708 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Blushing Pink Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL 98132-709_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-709 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Divine Wine Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL 98132-710_c37b213d-d584-4947-a8e4-6056c457b7a6 98132-710 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Fair Game Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL 98132-711_c37b213d-d584-4947-a8e4-6056c457b7a6 98132-711 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Dim The Light Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL 98132-712_c37b213d-d584-4947-a8e4-6056c457b7a6 98132-712 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 In The Buff Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL 98132-713_c37b213d-d584-4947-a8e4-6056c457b7a6 98132-713 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Youre A Natural Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL 98132-714_c37b213d-d584-4947-a8e4-6056c457b7a6 98132-714 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Meet Me Latte Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL 98132-715_c37b213d-d584-4947-a8e4-6056c457b7a6 98132-715 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Sweet As Honey Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL 98132-716_c37b213d-d584-4947-a8e4-6056c457b7a6 98132-716 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Tan-Talize Me Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL 98132-717_c37b213d-d584-4947-a8e4-6056c457b7a6 98132-717 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Almond The Nude Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL 98132-718_c37b213d-d584-4947-a8e4-6056c457b7a6 98132-718 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Caramel Kisses Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL 98132-719_c37b213d-d584-4947-a8e4-6056c457b7a6 98132-719 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 In The Dark Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL 98132-720_3c85e1ac-7b22-445c-bd55-ef7d5448f30d 98132-720 HUMAN OTC DRUG bareMinerals Advanced Protection SPF 20 Moisturizer Combination Skin Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20131231 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE 50; 30 mg/mL; mg/mL 98132-721_7f668ca5-1357-4899-b8b5-d39825aa1db8 98132-721 HUMAN OTC DRUG bareMinerals Advanced Protection SPF 20 Moisturizer Sheer Tint Combination Skin Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20131231 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE 50; 30 mg/mL; mg/mL 98132-722_605838e6-ee08-42c8-be1a-a3aa20b9b50c 98132-722 HUMAN OTC DRUG bareMinerals Advanced Protection SPF 20 Moisturizer Normal to Dry Skin Titanium Dioxide LOTION TOPICAL 20131231 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 60 mg/mL 98132-723_63d8d0cd-6fa7-4ed5-a014-a4b09ba348a9 98132-723 HUMAN OTC DRUG bareMinerals Advanced Protection SPF 20 Moisturizer Sheer Tint Normal to Dry Skin Titanium Dioxide LOTION TOPICAL 20131231 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 60 mg/mL 98132-724_9de5fcaf-8ee5-4b95-9c4e-3dd5a5774b02 98132-724 HUMAN OTC DRUG bareMinerals Daily Defense Broad Spectrum SPF 30 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20131231 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE 30; 1530 mg/mL; mg/mL 98132-725_a3f1626d-a481-4615-bd93-23d9e71dbf4a 98132-725 HUMAN OTC DRUG bareMinerals Blemish Therapy Sulfur POWDER TOPICAL 20131231 OTC MONOGRAPH FINAL part333D Bare Escentuals Beauty, Inc. SULFUR 30 mg/g 98132-726_e5f6f077-bbe4-4ec2-a089-c7b2b32c680f 98132-726 HUMAN OTC DRUG bareMinerals Prime Time BB Primer Daily Defense Broad Spectrum SPF 30 Fair Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE 26; 62 mg/mL; mg/mL 98132-727_e5f6f077-bbe4-4ec2-a089-c7b2b32c680f 98132-727 HUMAN OTC DRUG bareMinerals Prime Time BB Primer Daily Defense Broad Spectrum SPF 30 Light Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE 26; 62 mg/mL; mg/mL 98132-728_e5f6f077-bbe4-4ec2-a089-c7b2b32c680f 98132-728 HUMAN OTC DRUG bareMinerals Prime Time BB Primer Daily Defense Broad Spectrum SPF 30 Medium Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE 26; 62 mg/mL; mg/mL 98132-729_e5f6f077-bbe4-4ec2-a089-c7b2b32c680f 98132-729 HUMAN OTC DRUG bareMinerals Prime Time BB Primer Daily Defense Broad Spectrum SPF 30 Tan Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE 26; 62 mg/mL; mg/mL 98132-730_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-730 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Porcelain Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-731_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-731 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Shell Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-732_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-732 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Linen Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-733_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-733 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Ivory Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-734_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-734 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Cream Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-735_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-735 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Satin Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-736_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-736 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Natural Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-737_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-737 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Beige Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-738_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-738 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Nude Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-739_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-739 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Buff Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-740_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-740 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Latte Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-741_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-741 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Sand Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-742_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-742 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Tan Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-743_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-743 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Caramel Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-744_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-744 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Honey Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-745_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-745 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Almond Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-746_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-746 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Maple Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-747_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-747 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Walnut Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-748_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-748 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Espresso Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-749_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-749 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Mocha Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL 98132-750_80d8d989-51d6-4912-bfd0-ca99b69be7c3 98132-750 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Mineral Veil Finishing Broad Spectrum SPF 20 Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20140315 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE .2; .2 g/g; g/g 98132-870_3d4a19fe-fbe5-455a-82f6-c40666ae7b37 98132-870 HUMAN OTC DRUG Medium Tan Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20101021 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 6; 22 g/100g; g/100g 98132-871_9868751e-eb22-4e5d-9475-014cefd78a54 98132-871 HUMAN OTC DRUG Fair Foundation SPF 15 Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20101016 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 25; 19 g/100g; g/100g 98132-872_2d9bce93-3f3d-4795-ba1b-27bbf735b228 98132-872 HUMAN OTC DRUG Fairly Light Foundation SPF 15 Titanium Dioxide POWDER TOPICAL 20101006 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 25 g/100g 98132-873_eeefcd92-db23-4f7f-8605-4b7b2b70580e 98132-873 HUMAN OTC DRUG Light Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20101002 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 16; 18 g/100g; g/100g 98132-876_3713ec88-b55b-4951-b52d-45bdc9efc2b0 98132-876 HUMAN OTC DRUG Bisque Foundation SPF 20 Titanium Dioxide POWDER TOPICAL 20120525 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 24 g/100g 98132-877_eeefcd92-db23-4f7f-8605-4b7b2b70580e 98132-877 HUMAN OTC DRUG Light Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 16; 18 g/100g; g/100g 98132-879_9868751e-eb22-4e5d-9475-014cefd78a54 98132-879 HUMAN OTC DRUG Fair Foundation SPF 15 Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 25; 19 g/100g; g/100g 98132-880_179c1df2-9660-4c0d-b9a5-4128d08d2260 98132-880 HUMAN OTC DRUG Medium Foundation SPF 15 Titanium Dioxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 25 g/100g 98132-881_467bc3ea-a9bd-475a-8f9a-a958a1ce6638 98132-881 HUMAN OTC DRUG Medium Beige Foundation SPF 15 Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20120114 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 12; 21 g/100g; g/100g 98132-882_3d4a19fe-fbe5-455a-82f6-c40666ae7b37 98132-882 HUMAN OTC DRUG Medium Tan Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 6; 22 g/100g; g/100g 98132-883_5a5251e4-13f1-466a-8966-fcd37664318f 98132-883 HUMAN OTC DRUG Tan Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 20 g/100g; g/100g 98132-884_e1270697-fded-43ab-b53d-07b67b14d05a 98132-884 HUMAN OTC DRUG Warm Tan Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 20 g/100g; g/100g 98132-885_5190d2ac-334d-4720-a452-d4f2ec089d96 98132-885 HUMAN OTC DRUG Golden Deep Foundation SPF 15 Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 20 g/100g; g/100g 98132-887_015dd32a-11cc-433c-8b97-f636e956782b 98132-887 HUMAN OTC DRUG Deepest Deep Zinc Oxide POWDER TOPICAL 20100113 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE 18 g/100g 98132-888_50a12509-b6de-4abd-a1aa-8aff0b4ebf21 98132-888 HUMAN OTC DRUG Medium Deep Foundation SPF 15 Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20120730 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 20 g/100g; g/100g 98132-889_3ee69419-86c7-4177-886e-bafc40ea4cfe 98132-889 HUMAN OTC DRUG Medium Dark Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 20 g/100g; g/100g 98132-890_3b6f890b-9ec7-4fa2-a3f8-1d24233cd35d 98132-890 HUMAN OTC DRUG Golden Dark Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 20 g/100g; g/100g 98132-891_39b9a8d9-05db-41d9-b8fd-60a714d1aa18 98132-891 HUMAN OTC DRUG Golden Medium Foundation SPF 15 Titanium Dioxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 25 g/100g 98132-893_d1d7af80-6692-4807-b904-acf8e1a5fa06 98132-893 HUMAN OTC DRUG Dark Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 20 g/100g; g/100g 98132-902_5a9b2d8b-9eff-4367-8a75-1e61ab27f9e7 98132-902 HUMAN OTC DRUG Honey Bisque Foundation SPF 20 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 20; 20 g/100g; g/100g 98132-903_44fec199-21ac-44f0-a0d6-9130cb48ad31 98132-903 HUMAN OTC DRUG Summer Bisque Foundation SPF 20 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120212 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 20; 20 g/100g; g/100g 98132-904_ea41fc02-08ed-47b9-953c-da23330ec2f8 98132-904 HUMAN OTC DRUG BareMinerals Multi-Tasking SPF 20 Concealer Dark Bisque Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 20; 20 g/100g; g/100g 98132-920_ca213e30-9b91-4ec2-8b4d-7304545affe8 98132-920 HUMAN OTC DRUG Deep Bisque Foundation SPF 20 Titanium Dioxide, Zinc oxide POWDER TOPICAL 20120212 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 16; 10 g/100g; g/100g 98132-923_810dc98b-c256-4f0c-8a33-ec41137e20e6 98132-923 HUMAN OTC DRUG Golden Fair Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 25; 7.2 g/100g; g/100g 98132-924_822c0ccb-3a77-436d-88c6-dacc56749a95 98132-924 HUMAN OTC DRUG Fairly Medium Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 25; 9.3 g/100g; g/100g 99207-010_c966c002-0982-4fc2-8704-3273f7d9e3a0 99207-010 HUMAN PRESCRIPTION DRUG Loprox ciclopirox SHAMPOO TOPICAL 20030320 NDA NDA021159 Medicis Pharmaceutical Corp CICLOPIROX 10 mg/.96mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] 99207-130_c08e30fc-ad8b-4bc0-ab9f-644021a906bb 99207-130 HUMAN PRESCRIPTION DRUG MetroGel-Vaginal metronidazole GEL VAGINAL 20111128 NDA NDA020208 Medicis Pharmaceutical Corp METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] 99207-170_f1db175a-67bb-4cd3-8df6-19178cf92f70 99207-170 HUMAN PRESCRIPTION DRUG Minitran NITROGLYCERIN PATCH TRANSDERMAL 20120221 ANDA ANDA089771 Medicis Pharmaceutical Corp NITROGLYCERIN 9 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 99207-171_f1db175a-67bb-4cd3-8df6-19178cf92f70 99207-171 HUMAN PRESCRIPTION DRUG Minitran NITROGLYCERIN PATCH TRANSDERMAL 20120221 ANDA ANDA089772 Medicis Pharmaceutical Corp NITROGLYCERIN 18 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 99207-172_f1db175a-67bb-4cd3-8df6-19178cf92f70 99207-172 HUMAN PRESCRIPTION DRUG Minitran NITROGLYCERIN PATCH TRANSDERMAL 20120221 ANDA ANDA089773 Medicis Pharmaceutical Corp NITROGLYCERIN 36 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 99207-173_f1db175a-67bb-4cd3-8df6-19178cf92f70 99207-173 HUMAN PRESCRIPTION DRUG Minitran NITROGLYCERIN PATCH TRANSDERMAL 20120221 ANDA ANDA089774 Medicis Pharmaceutical Corp NITROGLYCERIN 54 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] 99207-240_f27e8127-5650-452e-a4ce-6f7ff49de135 99207-240 HUMAN PRESCRIPTION DRUG Calcium Disodium Versenate EDETATE CALCIUM DISODIUM INJECTION INTRAMUSCULAR; INTRAVENOUS 20130621 NDA NDA008922 Medicis Pharmaceutical Corp EDETATE CALCIUM DISODIUM 200 mg/mL Lead Chelating Activity [MoA],Lead Chelator [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] 99207-260_abff0acf-1669-4caa-b031-dd83d6a4bac3 99207-260 HUMAN PRESCRIPTION DRUG Aldara imiquimod CREAM TOPICAL 20111128 NDA NDA020723 Medicis Pharmaceutical Corp IMIQUIMOD 50 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 99207-270_5891741a-0467-4e69-a361-d4a1b48421b3 99207-270 HUMAN PRESCRIPTION DRUG Zyclara imiquimod CREAM TOPICAL 20111128 NDA NDA022483 Medicis Pharmaceutical Corp IMIQUIMOD 37.5 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 99207-271_5891741a-0467-4e69-a361-d4a1b48421b3 99207-271 HUMAN PRESCRIPTION DRUG Zyclara imiquimod CREAM TOPICAL 20120101 NDA NDA022483 Medicis Pharmaceutical Corp IMIQUIMOD 37.5 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 99207-276_5891741a-0467-4e69-a361-d4a1b48421b3 99207-276 HUMAN PRESCRIPTION DRUG Zyclara imiquimod CREAM TOPICAL 20120229 NDA NDA022483 Medicis Pharmaceutical Corp IMIQUIMOD 2.5 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] 99207-290_3b1df201-0ddf-4de8-8e75-ebbc9eea0331 99207-290 HUMAN OTC DRUG Esoterica Nighttime with Moisturizers hydroquinone CREAM TOPICAL 20050601 OTC MONOGRAPH NOT FINAL part358A Medicis Pharmaceutical Corp HYDROQUINONE 20 mg/g 99207-291_922de4ce-7b60-418b-8b71-ddd2f6c311f3 99207-291 HUMAN OTC DRUG Esoterica Daytime with Moisturizers and Sunscreen hydroquinone, oxybenzone, and padimate o CREAM TOPICAL 20050601 OTC MONOGRAPH NOT FINAL part358A Medicis Pharmaceutical Corp HYDROQUINONE; OXYBENZONE; PADIMATE O 20; 25; 33 mg/g; mg/g; mg/g 99207-292_7be41565-1714-46da-bb4c-2ba6957780d4 99207-292 HUMAN OTC DRUG Esoterica Daytime with Sunscreen hydroquinone, oxybenzone, and padimate o CREAM TOPICAL 20050601 OTC MONOGRAPH NOT FINAL part358A Medicis Pharmaceutical Corp HYDROQUINONE; OXYBENZONE; PADIMATE O 20; 25; 33 mg/g; mg/g; mg/g 99207-300_44970114-46e6-431e-bc73-fe5195fa3ea2 99207-300 HUMAN PRESCRIPTION DRUG ZIANA clindamycin phosphate and tretinoin GEL TOPICAL 20061201 NDA NDA050802 Medicis Pharmaceutical Corp CLINDAMYCIN PHOSPHATE; TRETINOIN 12; .25 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient],Retinoid [EPC],Retinoids [Chemical/Ingredient] 99207-463_374f2082-ede9-4188-82c3-7a61794b0a13 99207-463 HUMAN PRESCRIPTION DRUG Solodyn minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090723 NDA NDA050808 Medicis Pharmaceutical Corp. MINOCYCLINE HYDROCHLORIDE 65 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 99207-464_374f2082-ede9-4188-82c3-7a61794b0a13 99207-464 HUMAN PRESCRIPTION DRUG Solodyn minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090723 NDA NDA050808 Medicis Pharmaceutical Corp. MINOCYCLINE HYDROCHLORIDE 115 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 99207-465_374f2082-ede9-4188-82c3-7a61794b0a13 99207-465 HUMAN PRESCRIPTION DRUG Solodyn minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100927 NDA NDA050808 Medicis Pharmaceutical Corp. MINOCYCLINE HYDROCHLORIDE 55 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 99207-466_374f2082-ede9-4188-82c3-7a61794b0a13 99207-466 HUMAN PRESCRIPTION DRUG Solodyn minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100927 NDA NDA050808 Medicis Pharmaceutical Corp. MINOCYCLINE HYDROCHLORIDE 80 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 99207-467_374f2082-ede9-4188-82c3-7a61794b0a13 99207-467 HUMAN PRESCRIPTION DRUG Solodyn minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100927 NDA NDA050808 Medicis Pharmaceutical Corp. MINOCYCLINE HYDROCHLORIDE 105 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] 99207-500_2ff599d6-c672-4b7c-898f-e0e1ae8b818c 99207-500 HUMAN PRESCRIPTION DRUG Dysport botulinum toxin type a INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20090525 BLA BLA125274 Medicis Pharmaceutical Corp BOTULINUM TOXIN TYPE A 300 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] 99207-525_0d3d7d01-e405-4410-b2d7-27a9acf5f333 99207-525 HUMAN PRESCRIPTION DRUG Vanos fluocinonide CREAM TOPICAL 20060313 NDA NDA021758 Medicis Pharmaceutical Corp FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] 99207-850_67655661-38cd-4ded-8e78-98922ef0a156 99207-850 HUMAN PRESCRIPTION DRUG Luzu LULICONAZOLE CREAM TOPICAL 20131114 NDA NDA204153 Medicis Pharmaceutical Corp. LULICONAZOLE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] 99528-3590_b7bd09a7-0c7a-44f1-b14e-fc823dcd813f 99528-3590 HUMAN OTC DRUG Kool Comfort Pain Relieving Roll-On Menthol LOTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part348 Wonder Laboratories MENTHOL 3.5 g/100g